Document 3e1gNMQY18j3NEqaJKGNK58yn

Sponsor: 3M St. Paul, Minnesota FINAL REPORT Study Title: 26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys Author: Peter J. Thomford, PhD Study Completion Date: January 11, 2002 Testing Facility: Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Laboratory Study Identification: Covance 6329-223 Sponsor Study Identification: 3M Study No. T-6295.7 Volume I of II Page 1 of 1086 Covance 6329-223 3M T-6295.7 COMPLIANCE STATEMENT 26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys All aspects of this study were in accordance with the Environmental Protection Agency Good Laboratory Practice Regulations, 40 CFR 792, with the exception that the analysis of fecal samples for urobilinogen at the Mayo Clinic were not done in compliance with Good Laboratory Practice Regulations. Andrew M. Seacat, PhD Date Study Monitor 3M 2 Covance 6329-223 3M T-6295.7 QUALITY ASSURANCE STATEMENT This report has been reviewed by the Quality Assurance Unit of Covance Laboratories Inc., in accordance with the Environmental Protection Agency (EPA) Good Laboratory Practice Standards, 40 CFR 792. The following inspections were conducted and findings reported to the study director and study director management. Inspection Dates From To 08/06/98 08/06/98 08/24/98 08/24/98 11/25/98 11/25/98 03/03/99 03/03/99 04/09/99 04/12/99 05/23/99 05/23/99 09/27/99 09/27/99 10/22/99 10/25/99 10/20/99 10/27/99 02/11/00 02/13/00 03/16/00 03/16/00 03/13/00 03/23/00 04/04/00 04/04/00 04/18/00 05/05/00 05/31/00 05/31/00 10/23/01 10/23/01 12/18/01 12/18/01 Phase Test Article Preparation Protocol Review Body Weight Analytical Laboratory Inspection Protocol Amendment Review Protocol Amendment Review Protocol Amendment Review Data Review Data Review Protocol Amendment Review Protocol Amendment Review Data Review Protocol Amendment Review Report Review Protocol Amendment Review Protocol Amendment Review Report Review Date Reported to Study Director and Study Director Management 08/06/98 08/24/98 11/25/98 03/03/99 04/12/99 05/23/99 09/27/99 10/27/99 10/27/99 02/13/00 03/16/00 03/23/00 04/04/00 05/09/00 05/31/00 10/23/01 12/18/01 3 Covance 6329-223 3M T-6295.7 STUDY IDENTIFICATION 26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys Test Material Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) Sponsor 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Study Monitor Andrew M. Seacat, PhD 3M 651.575.3161 Alternate Study Monitor Marvin T. Case, DVM, PhD 3M Toxicology Services 651.733.5180 Study Location Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Study Director Peter J. Thomford, PhD Covance Laboratories Inc. PO Box 7545 Madison, Wisconsin 53707-7545 608.241.7207 Study Timetable Study Initiation Date In-Life (Experimental) Start Date In-Life Termination Date Experimental Termination Date August 20, 1998 August 26, 1998 March 8, 2000 December 21, 2001 4 Covance 6329-223 3M T-6295.7 KEY PERSONNEL 26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys Study Director Study Toxicologist Study Coordinator Manager, Large Animal Toxicology Supervisor, Dose Formulation Associate Director, Laboratory Animal Medicine Clinical Pathologist Supervisor, Clinical Pathology Anatomic Pathologist Supervisor, Anatomic Pathology Supervisor, Anatomic Pathology Consultant Consultant Consultant Consultant Consultant Peter J. Thomford, PhD Dale Aldridge, BS Elizabeth A. Disch, BA Sharon Dunn, LATG, AT Dixie Bushee, BS, LATG Donna J. Clemons, DVM, MS Diplomate, ACLAM Robert L. Hall, DVM, PhD Diplomate, ACVP (Clinical Pathology) Ronald Markevitch, BS, MT (ASCP) Robert A. Leedle, DVM, PhD Diplomate, ACVP Laurie J. Schuller, BA, LAT Kimberly W. Durland, BS, HT Stephen I. Bistner, DVM Diplomate, ACVO Veterinary Ophthalmologist Dr. Saroj Das AniLytics Inc. Sandra R. Eldridge, PhD Pathology Associates North Carolina Division, A Charles River Company Sharon Ambrose Pathology Associates North Carolina Division, A Charles River Company Dr. Joe McConnell Mayo Clinic 5 Covance 6329-223 3M T-6295.7 VOLUME I OF II CONTENTS Page ABSTRACT.................................................................................................................. 11 PURPOSE..................................................................................................................... 14 REGULATORY COMPLIANCE.................................................................................. 14 TEST MATERIAL, VEHICLE, AND SOLVENT......................................................... 14 Test Material ............................................................................................................. 14 Vehicle...................................................................................................................... 14 Solvent ...................................................................................................................... 15 Gelatin Capsules........................................................................................................ 15 Reserve (Archive) Samples........................................................................................ 15 Disposition ................................................................................................................ 15 TEST ANIMALS AND HUSBANDRY........................................................................ 15 Animals..................................................................................................................... 15 Identification ............................................................................................................. 16 Justification ............................................................................................................... 16 Husbandry................................................................................................................. 16 Acclimation............................................................................................................... 17 PROCEDURES............................................................................................................. 17 Group Designations and Dosage Levels..................................................................... 17 Dosing Procedures..................................................................................................... 18 Dose Analyses........................................................................................................... 19 Observation of Animals............................................................................................. 19 Clinical Pathology ..................................................................................................... 20 Blood Hormone Determination.................................................................................. 21 Serum PFOS Level Determination............................................................................. 21 Additional Serum Collection ..................................................................................... 22 Urine and Feces PFOS Level Determination.............................................................. 22 Additional Fecal Samples .......................................................................................... 23 Interim Liver Biopsy Samples ................................................................................... 23 Terminal Liver Biopsy Samples................................................................................. 23 Anatomic Pathology - Terminal Sacrifice .................................................................. 24 Anatomic Pathology - Recovery Sacrifice.................................................................. 26 Statistical Analyses.................................................................................................... 27 Record Retention....................................................................................................... 28 6 Covance 6329-223 3M T-6295.7 VOLUME I OF II CONTENTS (Continued) Page RESULTS AND DISCUSSION .................................................................................... 28 Observation of Animals............................................................................................. 28 Clinical Pathology ..................................................................................................... 30 Palmitoyl CoA Oxidase Determination...................................................................... 31 Blood Hormone Determination.................................................................................. 31 Anatomic Pathology .................................................................................................. 31 CONCLUSION............................................................................................................. 33 SIGNATURES.............................................................................................................. 34 REFERENCES.............................................................................................................. 35 OPHTHALMOLOGY REPORT ................................................................................... 36 PATHOLOGY REPORT............................................................................................... 37 COMMENTS ON THE DATA ..................................................................................... 45 CODES, ABBREVIATIONS, AND UNITS.................................................................. 47 General Codes and Abbreviations.............................................................................. 48 Codes for Clinical Pathology..................................................................................... 49 Abbreviations and Units for Clinical Hematology...................................................... 52 Abbreviations and Units for Clinical Chemistry......................................................... 54 Abbreviations and Units for Clinical Urinalysis......................................................... 56 Codes for Anatomic Pathology.................................................................................. 57 FIGURES 1 Mean Body Weight Data (kg) - Males.................................................................. 59 2 Mean Body Weight Data (kg) - Females .............................................................. 60 TABLES 1 Summary of Clinical Observations - Treatment ................................................... 61 2 Summary of Clinical Observations - Recovery (Days 186 through 365)............... 65 3 Summary of Clinical Observations - Recovery (Days 366 through 561)............... 66 4 Summary of Ophthalmic Observations - Treatment ............................................. 68 5 Summary of Ophthalmic Observations - Recovery............................................... 70 6 Summary of Body Weight Data (kg) - Treatment................................................. 71 7 Summary of Body Weight Data (kg) - Recovery.................................................. 76 8 Summary of Clinical Hematology Data - Day -27................................................ 84 9 Summary of Clinical Hematology Data - Day 37 ................................................. 88 10 Summary of Clinical Hematology Data - Day 62 ................................................. 92 11 Summary of Clinical Hematology Data - Day 91 ................................................. 96 7 Covance 6329-223 3M T-6295.7 VOLUME I OF II CONTENTS (Continued) Page TABLES 12 Summary of Clinical Hematology Data - Day 153 ............................................. 100 13 Summary of Clinical Hematology Data - Day 182 ............................................. 104 14 Summary of Clinical Hematology Data - Day 217 ............................................. 108 15 Summary of Clinical Hematology Data - Day 245 ............................................. 112 16 Summary of Clinical Hematology Data - Day 274 ............................................. 116 17 Summary of Clinical Hematology Data - Day 322 ............................................. 120 18 Summary of Clinical Hematology Data - Day 364 ............................................. 124 19 Summary of Clinical Hematology Data - Day 456 ............................................. 128 20 Summary of Clinical Hematology Data - Day 546 ............................................. 132 21 Summary of Clinical Chemistry Data - Day -27................................................. 136 22 Summary of Clinical Chemistry Data - Day 37 .................................................. 142 23 Summary of Clinical Chemistry Data - Day 62 .................................................. 148 24 Summary of Clinical Chemistry Data - Day 91 .................................................. 154 25 Summary of Clinical Chemistry Data - Day 153 ................................................ 160 26 Summary of Clinical Chemistry Data - Day 182 ................................................ 166 27 Summary of Clinical Chemistry Data - Day 217 ................................................ 172 28 Summary of Clinical Chemistry Data - Day 245 ................................................ 178 29 Summary of Clinical Chemistry Data - Day 274 ................................................ 184 30 Summary of Clinical Chemistry Data - Day 322 ................................................ 190 31 Summary of Clinical Chemistry Data - Day 364 ................................................ 196 32 Summary of Clinical Chemistry Data - Day 456 ................................................ 202 33 Summary of Clinical Chemistry Data - Day 546 ................................................ 208 34 Summary of Clinical Urinalysis Data - Day -27 ................................................. 214 35 Summary of Clinical Urinalysis Data - Day 37 .................................................. 216 36 Summary of Clinical Urinalysis Data - Day 62 .................................................. 218 37 Summary of Clinical Urinalysis Data - Day 91 .................................................. 220 38 Summary of Clinical Urinalysis Data - Day 153 ................................................ 222 39 Summary of Clinical Urinalysis Data - Day 182 ................................................ 224 40 Summary of Clinical Urinalysis Data - Day 217 ................................................ 226 41 Summary of Clinical Urinalysis Data - Day 245 ................................................ 228 42 Summary of Clinical Urinalysis Data - Day 274 ................................................ 230 43 Summary of Clinical Urinalysis Data - Day 322 ................................................ 232 44 Summary of Clinical Urinalysis Data - Day 364 ................................................ 234 45 Summary of Clinical Urinalysis Data - Day 456 ................................................ 236 46 Summary of Clinical Urinalysis Data - Day 546 ................................................ 238 47 Summary of Palmitoyl CoA Oxidase Determinations - Terminal Sacrifice......... 240 48 Summary of Organ Weight Data - Terminal Sacrifice ........................................ 242 49 Incidence of Macroscopic Observations - Terminal Sacrifice ............................. 272 50 Incidence of Macroscopic Observations - Recovery Sacrifice ............................ 275 8 Covance 6329-223 3M T-6295.7 VOLUME I OF II CONTENTS (Continued) Page TABLES 51 Incidence of Microscopic Observations - Terminal Sacrifice.............................. 276 52 Incidence of Microscopic Observations - Recovery Sacrifice ............................. 286 APPENDIX 1.............................................................................................................. 287 Protocol Deviations ................................................................................................. 288 Protocol................................................................................................................... 293 Protocol Amendment No. 1 ..................................................................................... 311 Protocol Amendment No. 2 ..................................................................................... 320 Protocol Amendment No. 3 ..................................................................................... 328 Protocol Amendment No. 4 ..................................................................................... 334 APPENDIX 2.............................................................................................................. 336 Individual Animal Fate Data.................................................................................... 337 Individual Clinical Observations.............................................................................. 339 Individual Ophthalmic Observations........................................................................ 481 APPENDIX 3.............................................................................................................. 496 Individual Body Weight Data (kg)........................................................................... 497 VOLUME II OF II APPENDIX 4.............................................................................................................. 511 Individual Clinical Hematology Data....................................................................... 512 Individual Clinical Chemistry Data.......................................................................... 614 Individual Clinical Urinalysis Data.......................................................................... 728 APPENDIX 5.............................................................................................................. 818 Individual Palmitoyl CoA Oxidase Determinations.................................................. 819 Individual Anatomic Pathology Data ....................................................................... 823 APPENDIX 6.............................................................................................................. 907 AniLytics Inc. Quality Assurance Statements .......................................................... 908 Summary and Individual Blood Hormone Determination......................................... 917 APPENDIX 7.............................................................................................................. 963 Cell Proliferation Report ......................................................................................... 964 APPENDIX 8.............................................................................................................. 977 Electron Microscopic Evaluation of Liver in Cynomolgus Monkeys........................ 978 9 Covance 6329-223 3M T-6295.7 VOLUME II OF II CONTENTS (Continued) Page APPENDIX 9............................................................................................................ 1069 Urobilinogen Analysis Report ............................................................................... 1070 APPENDIX 10.......................................................................................................... 1072 Dose Confirmation Analysis Report ...................................................................... 1073 Compound Stability Report ................................................................................... 1078 Analytical Laboratory Report ................................................................................ 1080 Certificate of Analysis ........................................................................................... 1083 Quality Assurance Statement ................................................................................. 1086 10 ABSTRACT Covance 6329-223 3M T-6295.7 The purpose of this study was to assess the effect of the test material, Perfluorooctane Sulfonic Acid Potassium Salt [PFOS; T-6295 (hereafter referred to as PFOS)] on critical enzyme levels, hormones, and other selected biochemical parameters when administered daily by oral capsule to cynomolgus monkeys for at least 26 weeks. The treatment period was followed by an approximate 52-week recovery period. Male and female cynomolgus monkeys were assigned to four groups (six animals/sex in Groups 1, 3, and 4; four animals/sex in Group 2). Each group received dose preparations containing the vehicle, lactose, or 0.03, 0.15, or 0.75 mg of PFOS/kg of body weight/day (mg/kg/day). Two animals/group in Groups 1, 3, and 4 were in a recovery period and were not treated for at least 52 weeks following the 26 week treatment period. Food was provided ad libitum, except when animals were fasted. Water was provided ad libitum. The animals were observed twice daily (a.m. and p.m.) for mortality and moribundity. At least once daily, animals were examined for abnormalities and signs of toxicity, and food consumption was assessed qualitatively. Ophthalmic examinations were done before initiation of treatment and during Weeks 26 and 52. Body weight data were recorded weekly before initiation of treatment, on Days -1 and 1, and weekly thereafter. Blood and urine samples were collected for clinical hematology, clinical chemistry, and urinalysis tests before initiation of treatment and at specified intervals during treatment and recovery. Blood was also collected for blood hormone and PFOS level determinations before, during, and after treatment at specified intervals. Feces and liver samples were also collected at specified intervals. On Day 155 (Week 23), one male given 0.75 mg/kg/day died, and on Day 179 (Week 26), one male given 0.75 mg/kg/day was sacrificed due to poor health. On Days 184 and 185 (Week 27), four animals/sex/group (Groups 1 through 3) and four females and two males (Group 4) were anesthetized, weighed, exsanguinated, and necropsied. At necropsy at the scheduled and unscheduled sacrifices, a serum sample was collected, macroscopic observations were recorded, selected organs were weighed, and selected tissues were collected and preserved. Microscopic examinations were done on tissues from each animal in the control and high-dose groups and selected tissues from animals in the low-and mid-dose groups. Tissues were also collected for palmitoyl CoA oxidase determination, cell proliferation evaluation, PFOS determination, and electron microscopy. Additionally, the bile was collected from the gallbladder, and the gallbladder was preserved. At the recovery sacrifice on Day 549, the remaining Group 4 11 Covance 6329-223 3M T-6295.7 animals were anesthetized, weighed, exsanguinated, and necropsied. Macroscopic observations were recorded and specified tissues and serum were collected. Remaining animals in Groups 1 and 3 were transferred to Covance stock or transferred to a follow-up study, Covance 6329-268. At all dose levels, clinical observations, ophthalmic observations, and palmitoyl CoA oxidase determinations do not appear to be affected by treatment with PFOS. Two males given 0.75 mg/kg/day did not survive to scheduled termination. These deaths were preceded by some adverse clinical observations (constricted pupil, pale gums, abnormal feces, excessive salivation, labored respiration, dehydrated appearance, hypoactive, ataxic, recumbent, low food consumption) and appeared to be related to the administration of PFOS. When compared with animals given the control material, covariate adjusted mean body weights (CAM) for males given 0.75 mg/kg/day were slightly lower beginning at Week 21, and for females given 0.75 mg/kg/day CAM body weights were, in general, significantly lower beginning at Week 11. Similar decreases were not seen in the other treated groups; therefore, this finding is likely test material-related. Test material-related effects on body weights were not apparent during recovery. Low food consumption was noted sporadically for animals in the groups given the control material and 0.03 mg/kg/day throughout treatment. The incidence of low food consumption was generally higher in the groups given 0.15 or 0.75 mg/kg/day as compared to animals given the control material and appeared to be test material-related. During recovery, effects on food consumption were reversed. Estradiol values were generally lower on Days 62, 91, and 182 in males given 0.75 mg/kg/day, although because of the variation in the data only the Day 182 value was significant. Estrone values were generally higher in all of the treated females on Days 37, 62, and 91, although because of the variation in the data none of these values were significantly different, and this difference was not apparent on Day 182. Triiodothyronine values were notably lower in both males and females given 0.15 and 0.75 mg/kg/day on Days 91 and 182. With the single exception of males given 0.15 mg/kg/day on Day 91, all values were significantly lower. During recovery were occasional instances in which the hormone values in treated groups differed slightly from those of controls, but those differences were not consistent over time or between sexes, were not clearly dose-related, and did not appear to be clearly related to the administration of the test material. Apparent differences in the sexual maturity of both males and females used in this study complicates the interpretation of the hormone data. 12 Covance 6329-223 3M T-6295.7 The only clinical pathology parameters considered related to the test material were lower total cholesterol for animals given 0.75 mg/kg/day and lower high density lipoprotein cholesterol for animals given 0.15 or 0.75 mg/kg/day. These effects were reversed within the first 5 and 9 weeks of recovery, respectively. At the terminal sacrifice, increased liver weights, macroscopic observations of mottled liver, hepatocellular hypertrophy, and hepatocellular vacuolation in animals given 0.75 mg/kg/day were considered related to PFOS treatment. However, the microscopic examination liver biopsies taken during recovery did not indicate any test material-related findings and none of the macroscopic observations made at the recovery sacrifice were considered test material-related. There were no microscopic findings in the liver from the animals in the high-dose recovery group. This indicates that the hepatic test material-related effects were reversible. Treatment with PFOS by oral capsule for at least 26 weeks is generally well-tolerated in male and female cynomolgus monkeys at doses up to 0.15 mg/kg/day. Clinical and pathological findings considered to be associated with the treatment of PFOS after at least 26 weeks of treatment were found to be reversible during a 52-week recovery period. Based on the data presented in this report, the no-observable-adverse-effect level is 0.15 mg/kg/day. Dose analyses (provided by the Sponsor), fecal analysis results (provided by the Mayo Clinic) and electron microscopy results (provided by Pathology Associates North Carolina Division, A Charles River Company), were provided for inclusion in the final report. 13 PURPOSE Covance 6329-223 3M T-6295.7 The purpose of this study was to assess the effect of the test material on critical enzyme levels, hormones, and other selected biochemical parameters when administered daily by capsule to cynomolgus monkeys for at least 26 weeks. The treatment period was followed by an approximate 52-week recovery period. REGULATORY COMPLIANCE All aspects of this study were done in accordance with the Environmental Protection Agency Good Laboratory Practice Regulations, 40 CFR 792, with the exception that the analysis of fecal samples for urobilinogen at the Mayo Clinic were not done in compliance with Good Laboratory Practice Regulations. TEST MATERIAL, VEHICLE, AND SOLVENT Test Material The test material, Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295), Lot No. 217 (expiration date: August 31, 2001), is a white to off-white powder and is 86.9% pure. It was received at Covance on September 4, 1997. The test material was stored at room temperature. Information on synthesis methods, composition, or other characteristics that define the test material is on file with the Sponsor. Vehicle The vehicle was lactose (Spectrum, New Brunswick, New Jersey), Lot No. NN0192 (expiration date February 13, 1999). It was received at Covance on March 30, 1998. The vehicle was stored at room temperature. Information on synthesis methods, purity, stability, composition, or other characteristics that define the vehicle is on file with the manufacturer. 14 Covance 6329-223 3M T-6295.7 Solvent The solvent was acetone (Spectrum, Gardena, California), Lot No. LH0253, (expiration date June 2000). It was received at Covance on June 23, 1997. The solvent was stored at room temperature. Information on synthesis methods, composition, or other characteristics that define the solvent is on file with the manufacturer. Gelatin Capsules Gelatin capsules, Size Nos. 2 (Lot No. 122932, expiration date June 12, 2003) and 4 (Lot No. 544043, expiration date August 1, 2002) were manufactured by Torpac Inc., (Fairfield, New Jersey). Lot No. 122932 was received at Covance on June 12, 1998, and Lot No. 544043 was received on September 1 and November 10, 1998. The capsules were stored at room temperature. A copy of the Certificate of Analysis provided by the manufacturer is maintained in the data. Reserve (Archive) Samples A reserve sample (1 g) of each lot of the test material, vehicle, and each test material/lactose dilution was taken and stored at room temperature. These samples were transferred to the Sponsor after completion of the treatment phase (see Protocol Deviations). Disposition Remaining test material will be retained at Covance for use in possible future studies. TEST ANIMALS AND HUSBANDRY Animals Young adult to adult cynomolgus monkeys were obtained from Covance Research Products Inc. (Denver, Pennsylvania) on June 30, 1998. The animals weighed 2.4 to 4.4 kg at initiation of treatment. 15 Covance 6329-223 3M T-6295.7 Identification Each animal was assigned a permanent number upon arrival and identified with a collar tag before initiation of treatment. All data for an animal are recorded under this number. Justification PFOS is a known hepatic peroxisome proliferator (PP) in the rat. When exposed to a PP, nonhuman primates (such as the cynomolgus monkey) respond similarly to humans (i.e., low to no hepatic response) and therefore are an appropriate human surrogate species. Husbandry Animal Rooms 251, 258, 259, and 527 were used for this study. Environmental controls for the animal rooms were set to maintain 18 to 29oC, a relative humidity of 30 to 70%, and a 12-hour light/12-hour dark cycle. Variations from these conditions are documented in the data and are considered to have had no effect on the outcome of the study. The animals were housed individually in suspended, stainless-steel cages. Certified primate diet (#8726C, Harlan Teklad) was provided once or twice daily, unless otherwise specified. The lot numbers are recorded in the data. The diet is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Results of specified nutrient and contaminant analyses are on file with Covance-Madison. Fruits or additional supplements were provided, but did not require analysis. Water was provided ad libitum. Samples of the water are analyzed for specified microorganisms and environmental contaminants. The results are on file with Covance-Madison. There were no known contaminants in the diet or water at levels that would have interfered with this study. 16 Covance 6329-223 3M T-6295.7 Acclimation Twenty-four males and 24 females were received on June 30, 1998, and acclimated in Animal Room 251 for 57 days before initiation of treatment. In general, animals in this shipment appeared healthy. During acclimation, the animals were examined for abnormalities indicative of health problems. In addition, three tuberculosis tests, a physical examination, and a fecal flotation for parasites were performed on each animal. PROCEDURES This study was conducted in accordance with the Protocol dated August 20, 1998, and Protocol Amendment Nos. 1, 2, 3, and 4. The protocol, protocol amendments, and protocol deviations are in Appendix 1. Group Designations and Dosage Levels Selection of animals for the study was based on data collected during acclimation. Animals were assigned to treatment groups using a computerized blocking procedure designed to achieve body weight balance with respect to treatment group. Group 1 2 3 4 Dose Level (mg/kg/day)a 0a 0.03 0.15 0.75 Total Material Dose Level (mg/kg/day)b 30a 15b 6c 30c Number of Animals Males 6d Females 6d 4 4 6d 6d 6d 6d a The control group (Group 1) received the equivalent amount of lactose in gelatin capsules as the total material administered to Group 4. b The low-dose (Group 2) received the test material diluted with lactose (1:499, w:w). c The mid-dose (Group 3) and high-dose (Group 4) groups received the test material diluted with lactose (1:39, w:w). d Two animals in Groups 1, 3, and 4 designated as recovery animals were treated for at least 26 weeks, then treatment was discontinued, and the animals were observed for reversibility, persistence, or delayed occurrence of toxic effects for at least 52 weeks posttreatment. 17 Covance 6329-223 3M T-6295.7 Dosing Procedures Vehicle. Dose levels were based on the vehicle as supplied for Group 1. For Group 1 dose preparations, the specified amount of lactose was weighed, transferred into gelatin capsules, and the top and bottom halves of each capsule were joined. Capsules were prepared at least once weekly. Test Material. The test material/lactose preparations for Groups 2 through 4 were diluted once before initiation of treatment; capsules were prepared at least once weekly. A specified amount of test material was weighed, placed into a labeled mixing container, and the appropriate volume of acetone was added. After stirring manually until the test material was dissolved, the required amount of lactose was weighed and transferred to the container. The components were mixed thoroughly using a spatula. The prepared test material dilution was stirred periodically while allowed to stand exposed to the air until the acetone had evaporated. Preparations were diluted to facilitate capsule preparation. Samples of the finished mixture for dose analyses were taken directly from the container. The dose preparations were stored at room temperature between capsule preparations. The appropriate amount of prepared test material was weighed and transferred into Size 2 (Days 1 through 8) or 4 (Days 9 through 184) gelatin capsules and the top and bottom halves of each capsule were joined. Size 4 capsules were used instead of Size 2 to better facilitate dose administration. Individual daily doses were based on the most recently recorded body weight, with the exception of doses given on days when body weight measurements were performed; on those days, the previous body weight was used. All capsule preparations were stored at room temperature until used for dosing. Method of Administration. Gelatin capsules were used to facilitate comparison with data from previous toxicology studies that used the oral route. Also, oral is the most likely route of exposure in humans. Partial or intact capsules were noted in the vomitus of several animals on occasion; however, this is not considered to have adversely affected the results of the study. The dose preparations were administered orally in gelatin capsules once daily 7 days/week for at least 26 weeks (see Protocol Deviations for exceptions). 18 Covance 6329-223 3M T-6295.7 Dose Analyses Homogeneity and stability analyses were the responsibility of the Sponsor. Samples (approximately 1 g each) were taken from the top, middle, and bottom of the test material/lactose preparations on Day -15 for homogeneity analysis. Samples collected from the middle of the preparations were also designated for prestudy stability analysis. A set of samples (approximately 1 g each) were taken from the low- and high-dose test material/lactose preparations at the end of the treatment phase for test material content analysis. All samples were stored at room temperature until sent under ambient conditions to the Sponsor for analysis. Results of dose analyses were provided for inclusion in the final report. Observation of Animals Clinical Observations. The animals were observed twice daily (a.m. and p.m.) for mortality and moribundity. Animals were also observed at least once daily (a.m.) for signs of poor health or abnormal behavior, and food consumption was assessed qualitatively; only abnormal findings were recorded. Once weekly and on the day of scheduled sacrifice, each animal was observed; abnormal findings or an indication of normal was recorded (see Protocol Deviations for exceptions). Additionally, postdose observations were recorded during treatment approximately 30 to 90 minutes after the last dose administration; only abnormal findings were recorded. Ophthalmology. Ophthalmic examinations were done on each animal before initiation of treatment, before the scheduled terminal sacrifice during Week 26, and during Week 52 (see Protocol Deviations). The pupils were dilated with 1% Mydriacyl and the anterior portion of the eye, optic media, and ocular fundus were examined with an indirect ophthalmoscope by a board-certified ophthalmologist. Body Weights. Individual body weight data were recorded weekly before initiation of treatment, on Day -1, on the first day of treatment, and weekly thereafter. 19 Covance 6329-223 3M T-6295.7 Clinical Pathology Blood and urine samples were collected from each animal once before initiation of treatment (Day -27); on Days 37, 62, 91, 153, and 182 of treatment; and on Days 217, 245, 274, 322, 364, 456, and 546 during recovery (see Protocol Deviations). Animals were fasted overnight, and urine was collected overnight on wet ice before blood sampling; water was provided ad libitum. Blood was collected from the femoral vein. Potassium EDTA was the anticoagulant used for hematology tests; no anticoagulant was used for the chemistry tests. Blood samples were collected from the animal that was sacrificed at an unscheduled interval. Animals were bled in sequential order on Days 37, 62, and 91 and in random order at all other scheduled collections; this is not expected to have an impact on the clinical pathology results. The following were evaluated (see Protocol Deviations for exceptions). Hematology red blood cell (erythrocyte) count differential blood cell count hemoglobin segmented neutrophil count hematocrit lymphocyte count mean corpuscular volume monocyte count mean corpuscular hemoglobin eosinophil count mean corpuscular hemoglobin basophil count concentration blood cell morphology platelet count reticulocyte count white blood cell (leukocyte) count glucose urea nitrogen creatinine total protein albumin globulin total bilirubin cholesterol triglycerides alanine aminotransferase alkaline phosphatase aspartate aminotransferase gamma glutamyltransferase Clinical Chemistry sorbitol dehydrogenase creatine kinase calcium inorganic phosphorus sodium potassium chloride bile acids amylase lipase pancreatic-specific amylase high density lipoprotein (HDL) (effective with collection on Day 153) 20 Covance 6329-223 3M T-6295.7 volume (approximately 16 hours) specific gravity pH protein glucose ketones Urinalysis bilirubin blood urobilinogen microscopic examination of sediment appearance Blood Hormone Determination Blood samples (approximately 5 mL) were collected from each animal three times before initiation of treatment (Days -50, -40, and -27); on Days 37, 62, 91, and 182 of treatment; and on Days 217, 245, 274, 322, 364, 456, and 546 during recovery (see Protocol Deviations). Animals were fasted overnight. Blood was collected from a femoral vein without using an anticoagulant. Samples were allowed to clot and centrifuged within 1 hour after collection; serum was harvested. The serum was divided into two approximately equal aliquots and stored in a freezer, set to maintain -60 to -80oC, until packed on dry ice and shipped to AniLytics Inc. for analysis of cortisol, testosterone, estradiol, estrone, estriol, thyroid stimulating hormone, total triiodothyronine, and total thyroxin. Beginning with the collection on Day 322 the samples were also analyzed for free triiodothyronine and free thyroxin. Serum PFOS Level Determination Blood samples (approximately 2 mL) were collected from each animal once before initiation of treatment (Day -27); during Weeks 1 (Day 7), 2, 4, 6, 8, 12, 16, 20, 24, and 26, and 27 (Day 183) of treatment; and during Weeks 27 (Days 184, 185, and 187), 28 (Day 190), 29 (Day 198), 30 (Day 204), 31 (Day 211), 35, 39, 43, 47, 51, 53, 57, 61, 65, 69, 73, 77, and 79 (see Protocol Deviations). Animals were fasted overnight and water was provided ad libitum. Blood was collected from a femoral vein without using an anticoagulant. Samples were centrifuged within 1 hour after collection and serum was harvested. Serum samples were stored in a freezer, set to maintain -60 to -80oC, until packed on dry ice and shipped to the Sponsor for analysis. Results will reported separately. 21 Covance 6329-223 3M T-6295.7 Additional Serum Collection At the scheduled terminal necropsy and the necropsy of Animal No. I05506 (Group 4 male), blood samples (approximately 20 mL) were collected from the vena cava at the time of exsanguination. Samples were collected without using an anticoagulant and centrifuged within 1 hour of collection. Serum was harvested and stored in a freezer, set to maintain -60 to -80oC, until packed on dry ice and shipped to the Sponsor for possible future analysis. An aliquot (0.8 ml) of the additional serum collection samples collected from all animals from Groups 1, 2, 3, and 4 sacrificed at the terminal necropsy were sent on dry ice by the Sponsor to AniLytics for total triiodothyronine, total thyroxin, free triiodothyronine, and free thyroxin determinations. Additional serum samples collected at the terminal and recovery sacrifices were transferred by the Sponsor to Anilytics for analysis of estradiol, follicle stimulating hormone (FSH), and lutenizing hormone (LH) for females, and estradiol in males. Results were provided for inclusion in the final report. Additionally, samples were transferred by the Sponsor to the Mayo Clinic for analysis of triiodothyronine (T3), total thyroxin (T4), free thyroxin (free T4), and thyroid stimulating hormone (TSH). Additional reserve samples of serum were transferred for possible future anlaysis for estradiol. Any unused serum will be returned to the Sponsor. Results were provided for inclusion in the final report. Urine and Feces PFOS Level Determination Urine [at least 2 mL (see Protocol Deviations)] and feces (at least 5 g) were collected overnight on the first day of recovery (Day 184) and on Days 189, 216, 275, 321, and 366 during recovery. In addition, a 24-hour sample of urine and feces was collected before the completion of 52 weeks of recovery. Except for the first day of recovery, animals were not fasted. Samples were stored in a freezer set to maintain -10 to -30oC, until they were packed on dry ice and shipped to the Sponsor. The samples will be analyzed for PFOS. Results will be reported separately. 22 Covance 6329-223 3M T-6295.7 Additional Fecal Samples During Week 23, a fresh fecal sample (up to 5 g) was collected from all animals in the control and high-dose groups. Samples were collected in white polypropylene containers after pans were cleaned in the morning to ensure that the fecal samples were not more than 6 hours old (see Protocol Deviations). Samples were packed on dry ice and shipped to the Mayo Clinic for analysis of urobilinogen using a routine, standardized, colormetric assay. Results were provided for inclusion in the final report. Interim Liver Biopsy Samples A sample of liver (approximately 1 to 2 g) was collected by biopsy from animals in Group 4 only during recovery [Week 57 (Day 393), on the same day as the serum PFOS blood collection]. This sample was divided into four portions as follows. One subsample was preserved in 10% neutral-buffered formalin, embedded in paraffin, sectioned, stained with hematoxylin and eosin (duplicate slides were prepared), and examined microscopically. The second subsample was flash-frozen in liquid nitrogen and stored in a freezer, set to maintain -60 to -80oC, until shipped to the Sponsor for analysis (see Protocol Deviations). Results will be reported separately. The third subsample was processed to block stage for electron microscopic evaluation. The tissue blocks and a hematoxylin and eosin-stained slide for light microscopy were transferred to Pathology Associates. Tissues were processed and evaluated by electron microscopy by Pathology Associates. A report was provided by Pathology Assoicates for inclusion in the final report. The fourth subsample was flash-frozen in liquid nitrogen and stored in a freezer, set to maintain -60 to -80oC, until transferred to the Sponsor for possible future analysis. Terminal Liver Biopsy Samples A sample of liver (approximately 1 g) was collected by biopsy from all animals in Group 3 during recovery [Week 80 (Day 554), one week after the serum PFOS blood collection (see Protocol Deviations)]. This sample was flash-frozen in liquid nitrogen and stored in a freezer, set to maintain -60 to -80oC, until shipped to the Sponsor for analysis. Results will be reported separately. 23 Covance 6329-223 3M T-6295.7 Anatomic Pathology - Terminal Sacrifice Necropsy. A necropsy was done on Animal No. I05509 (Group 4 male) that died on Day 155 (Week 23) and Animal No. I05506 (Group 4 male) that was sacrificed in a moribund condition on Day 179 (Week 26). During Week 27 (Days 184 and 185) four animals/sex/group (Groups 1 through 3) and four females and two males (Group 4) were fasted overnight, anesthetized with ketamine and xylazine, weighed, bled for required tests, exsanguinated, and necropsied. Animals were necropsied in random order. The necropsy included a macroscopic examination of the external surface of the body; all orifices; the cranial cavity; the external surface of the brain; the nasal cavity and paranasal sinuses; cervical tissues and organs; and the thoracic, abdominal, and pelvic cavities and viscera. Organ Weights. At scheduled and unscheduled sacrifices, the following organs (when present) were weighed; paired organs were weighed separately. adrenal (2) brain epididymis (2) kidney (2) liver ovary (2) pancreas testis (2) thyroid (2) with parathyroid Organ-to-body weight percentages and organ-to-brain weight ratios were calculated. Palmitoyl CoA Oxidase Determinations. Representative samples of the right lateral lobe of liver were collected from each animal at the scheduled sacrifice, weighed, flash-frozen in liquid nitrogen, and stored in a freezer, set to maintain -60 to -80oC, until analyzed for palmitoyl CoA oxidase activity. Cell Proliferation Evaluation. Representative samples of the left lateral lobe of the liver, left and right testes, and pancreas were collected and preserved in zinc formalin. A second set of tissues (representative samples of the left lateral lobe of the liver, left and right testes, and pancreas) preserved in formalin without zinc were also prepared. After fixation, samples were embedded in paraffin and shipped to Pathology Associates North Carolina Division, A Charles River Company (Pathology Associates) for proliferation cell nuclear antigen (PCNA) evaluation, including the examination of slides stained with 24 Covance 6329-223 3M T-6295.7 hematoxylin and eosin (see Protocol Deviations). Results were provided by Pathology Associates for inclusion in the final report (Appendix 7). Liver PFOS Determination. A section of liver (approximately 20 g) was collected from each animal at the scheduled sacrifice, weighed, flash-frozen in liquid nitrogen, and stored in a freezer, set to maintain -60 to -80oC, until shipped with plasma samples to the Sponsor. Results will be reported separately. Gallbladder and Bile Collection. At the scheduled terminal sacrifice for each animal, bile was collected from the gallbladder, measured, transferred into a cryovial, and flash-frozen in liquid nitrogen. The gallbladder, once emptied, was weighed, and a section (approximately 4 to 5 mm) from the mid-portion was collected. The remaining gallbladder was placed in a cryovial and flash-frozen in liquid nitrogen. The bile and gallbladder samples were stored on dry ice until transferred to a freezer set to maintain -60 to -80oC. Samples were packed on dry ice and shipped to the Sponsor for possible future analysis. Tissue Preservation. The following tissues (when present) or representative samples were collected and preserved in 10% neutral-buffered formalin, unless otherwise specified (see Protocol Deviations). adrenal (2) aorta brain cecum cervix colon duodenum epididymis (2) esophagus eyes [(2) preserved in Davidson's fixative for all sacrificed animals] femur with bone marrow (articular surface of the distal end) gallbladder heart ileum jejunum kidney (2) lesions liver lung mammary gland mesenteric lymph node ovary (2) pancreas pituitary prostate rectum salivary gland [mandibular (2)] sciatic nerve seminal vesicle (2) skeletal muscle (thigh) skin spinal cord (cervical, thoracic, and lumbar) spleen 25 sternum with bone marrow stomach testis [(2) preserved in Bouin's solution for all sacrificed animals] thymus Covance 6329-223 3M T-6295.7 thyroid (2) with parathyroid trachea urinary bladder uterus vagina Histopathology. Tissues (as appropriate) were embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically from each animal in the control and high-dose groups (see Protocol Deviations for exceptions). In addition, liver and thymus for all animals in the low- and mid-dose groups and spinal cord gray matter from females in the low- and mid-dose groups were embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically. Other tissues, as appropriate, will be retained for possible future examination. Bone marrow smears from the sternum of each animal at scheduled and unscheduled sacrifices were prepared, stained with Wright's stain, and retained for possible examination. Electron Microscopy. A sample of the liver was collected from each animal at the scheduled terminal sacrifice. Tissues were processed into blocks and, along with a hematoxylin and eosin-stained slide, were shipped to Pathology Associates for analysis. Results were provided for inclusion in the final report. Anatomic Pathology - Recovery Sacrifice Termination. Remaining animals in Group 1 were transferred to Covance stock on Day 549 and remaining animals in Group 3 were transferred to Covance 6329-268 on Day 561. On Day 549, remaining animals in Group 4 were fasted overnight, anesthetized with ketamine and xylazine, weighed, exsanguinated, and necropsied. The necropsy of the animals in Group 4 included a macroscopic examination of the external surface of the body; all orifices; the cranial cavity; the external surface of the brain; the nasal cavity and paranasal sinuses; cervical tissues and organs; and the thoracic, abdominal, and pelvic cavities and viscera. Liver Samples. Samples of liver were collected from animals in Group 4 as follows. 26 Covance 6329-223 3M T-6295.7 One sample was preserved in 10% neutral-buffered formalin, embedded in paraffin, sectioned, stained with hematoxylin and eosin (duplicate slides were prepared), and examined microscopically. The second sample was flash-frozen in liquid nitrogen and stored in a freezer, set to maintain -60 to -80oC, until shipped to the Sponsor for analysis. Results will be reported separately. The third sample was processed to block stage for electron microscopic evaluation. The tissue blocks and a hematoxylin and eosin-stained slide for light microscopy were transferred to Pathology Associates. Tissues were processed and evaluated by electron microscopy by Pathology Associates. A report was provided by Pathology Associates for inclusion in the final report. Additional Tissue and Serum Samples. Samples of lung, kidney, spleen, thyroid, brain, abdominal fat, heart, (approximately 3 g each, if possible), and bile and serum (each as much as possible) were collected. These samples were flash-frozen in liquid nitrogen and stored in a freezer, set to maintain -60 to -80oC, until shipped to the Sponsor for possible future analysis. Statistical Analyses Levene's test (Levene, 1960) was done to test for variance homogeneity. In the case of heterogeneity of variance at p < 0.05, transformations were used to stabilize the variance. Comparison tests took variance heterogeneity into consideration. One-way analysis of variance [ANOVA (Winer, 1971a)] was used (if applicable) to analyze initial body weights, organ weights, palmitoyl CoA oxidase activities, continuous clinical pathology values, and blood hormone determinations. If the ANOVA was significant, Dunnett's t-test (Dunnett, 1964) was used for control versus treated group comparisons. One-way analysis of covariance [ANCOVA (Winer, 1971b)] was used to analyze body weights, with initial body weights as the covariate. If the ANCOVA was significant, covariate-adjusted means were used for control versus treated group comparisons. 27 Covance 6329-223 3M T-6295.7 Group comparisons (Groups 2 through 4 versus Group 1) were evaluated at the 5.0%, two-tailed probability level. Only data collected on or after the first day of treatment were analyzed statistically. Statistical analyses were not performed on data collected during recovery. Record Retention All raw data, documentation, records, protocol, and specimens generated as a result of this study will be archived in the storage facilities of Covance-Madison for a period of at least 1 year. At least one year after the submission of the final report, the Sponsor will determine the final disposition of the materials. All raw data stored on magnetic media and the protocol, study correspondence, and an original copy of the final report will be retained by Covance-Madison. Within 1 year after submission of the final report, all of the aforementioned materials from the Sponsor's designees (AniLytics Inc., 3M E. T. & S, Mayo Clinic, and Pathology Associates) will be sent to the Sponsor (Andrew Seacat, PhD, 3M) by the Sponsor's designees. RESULTS AND DISCUSSION Observation of Animals Clinical Observations. Clinical observations are summarized in Tables 1, 2, and 3; individual data are presented in Appendix 2. Individual animal fate data are also presented in Appendix 2. Animal Nos. I05506 and I05509 given 0.75 mg/kg/day (Group 4 males) did not survive to the scheduled terminal sacrifice. All other animals survived to the scheduled study termination. No clinical observations noted in the animals that survived to the terminal sacrifice or recovery were attributable to the administration of PFOS. Animal No. I05509 (Group 4 male) died after dosing on Day 155 (Week 23). On Day 154 (Week 22) observations of constricted pupil in both eyes and pale gums were noted. Observations noted on Day 155 prior to dosing included few, mucoid, liquid, and black-colored feces and low food consumption. Approximately 15 minutes after dosing, the animal was observed as hypoactive with labored respiration and pale gums. This 28 Covance 6329-223 3M T-6295.7 animal also appeared dehydrated and was cold to the touch. These observations persisted until approximately 30 minutes postdose when the animal was also noted as recumbent. Shortly thereafter, the animal died during an examination by a laboratory animal veterinarian. An enlarged liver was detected by palpation. The cause of death was determined to be pulmonary necrosis with severe acute inflammation. On Day 179 (Week 26), Animal No. I05506 (Group 4 male) was sacrificed in a moribund condition. Low food consumption was noted on Day 178 (Week 26) and at the a.m. observation interval on Day 179. Approximately 5 to 10 minutes postdose on Day 179, the animal had excessive salivation, labored respiration, and hypoactive and ataxic behavior. With the exception of excessive salivation, these findings continued to be observed approximately 3 hours postdose. The cause of the moribund condition was not determined. Two additional animals had noteworthy observations during treatment. One female in the group given the control material, Animal No. I05529, was examined by a laboratory animal veterinarian on Day 5 (Week 1) due to observations of dehydration, thin appearance, clear oral and nasal discharge, excessive salivation, and audible respiration. This animal was diagnosed with pneumonia and treated with Lactated Ringer's solution and antibiotics. This animal had recovered by Day 14 (Week 2). Animal No. I05534 (Group 4 female) was diagnosed with a tapeworm infection during Week 23 and was treated with praziquantel. Neither infection was test material-related. Clinical observations during recovery were typical of laboratory primates. Ophthalmology. Ophthalmic observations are summarized in Tables 4 and 5; individual data are presented in Appendix 2. There were no ophthalmic observations at the Week 26 or Week 52 examinations that were test material-related. Animal No. I05529 (Group 1 female) was noted as having increased myelination of the right optic nerve at the baseline and Week 52 ophthalmic examinations. Because this is a permanent, congenital condition, it was noted at the baseline and recovery examinations only and is not related to treatment with PFOS. Body Weights. Body weight data are illustrated in Figures 1 and 2 and summarized in Tables 6 and 7; individual data are presented in Appendix 3. 29 Covance 6329-223 3M T-6295.7 Covariate-adjusted mean (CAM) body weights were slightly lower in males given 0.75 mg/kg/day when compared with males given the control material beginning at Week 21; the difference was significant at Weeks 23 and 27. In females given 0.75 mg/kg/day, CAM body weights were significantly lower at Weeks 11 through 16, 19 through 23, and 25 through 27 when compared with females given the control material. These decreases were likely test material-related. Differences in body weights were not apparent during the recovery period. Food Consumption. Food consumption data are summarized in Tables 1, 2, and 3 (Summary of Clinical Observations); individual data are included in the individual clinical observations in Appendix 2. Low food consumption was noted sporadically for animals in the groups given the control material and 0.03 mg/kg/day. The incidence of low food consumption was generally higher in the groups given 0.15 and 0.75 mg/kg/day as compared to animals given the control material and appeared to be test material-related. During recovery, instances of low food consumption were sporadic and were similar for animals in the control and treated groups. Clinical Pathology Hematology, clinical chemistry, and urinalysis data are summarized in Tables 8 through 46; individual data are presented in Appendix 4. Administration of PFOS was associated with moderately to markedly lower total cholesterol for males and females given 0.75 mg/kg/day and high density lipoprotein cholesterol for males and females given 0.15 or 0.75 mg/kg/day. During the treatment period, the effect on total cholesterol became progressively worse over time. The effect on cholesterol was reversed within 5 weeks of the end of treatment, and the effect on high density lipoprotein cholesterol was reversed within 9 weeks of the end of treatment. Of uncertain relationship to administration of PFOS was lower total bilirubin concentration for males given 0.75 mg/kg/day and higher serum bile acid concentration for males given 0.75 mg/kg/day. These potential effects of the test material were very mild, and neither was considered adverse. 30 Covance 6329-223 3M T-6295.7 Palmitoyl CoA Oxidase Determination Palmitoyl CoA oxidase determinations are summarized in Table 47; individual data are presented in Appendix 5. Results of palmitoyl CoA oxidase determinations were not considered to be related to the test material. Blood Hormone Determination Summary and Individual Blood Hormone Data are presented in Appendix 6. Estradiol values were generally lower on Days 62, 91, and 182 in males given 0.75 mg/kg/day, although because of the variation in the data only the Day 182 value was significant. Estrone values were generally higher in all of the treated females on Days 37, 62, and 91, although because of the variation in the data none of these values were significantly different, and this difference was not apparent on Day 182. Triiodothyronine values were notably lower on Days 91 and 182 in both males and females given 0.15 or 0.75 mg/kg/day. With the single exception on Day 91 of males given 0.15 mg/kg/day, all values were significantly lower. There were several other instances in which the hormone values in treated groups differed from those of controls, but these differences were not consistent over time or between sexes, were not clearly dose-related, and did not appear to be related to the administration of the test material. During recovery were occasional instances in which the hormone values in treated groups differed slightly from those of controls, but those differences were not consistent over time or between sexes, were not clearly dose-related, and did not appear to be clearly related to the administration of the test material. Apparent differences in the sexual maturity of both males and females used in this study complicates the interpretation of the hormone data. Anatomic Pathology Terminal body weights, absolute organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios are summarized in Table 48; incidences of macroscopic and microscopic observations are summarized in Tables 49 through 52. Individual data are presented in Appendix 5. 31 Covance 6329-223 3M T-6295.7 Two of four males receiving 0.75 mg/kg/day (high dose) did not survive to the scheduled terminal sacrifice at Week 27. At the terminal sacrifice, females in the group receiving 0.75 mg/kg/day had increased absolute liver weight, liver-to-body weight percentages, and liver-to-brain weight ratios. In males, liver-to-body weight percentages were increased in the high-dose group compared to the control group. Absolute and relative liver weight increases were regarded as test material-related. Among the macroscopic observations, only "mottled" liver was considered test material-related. "Mottled" livers were observed in the two high-dose males and in one high-dose female. Of the two males not surviving until the scheduled terminal sacrifice, one had "mottled" and "large" liver. Microscopic examination of animals sacrificed at Week 27 and of the two males sacrificed at an unscheduled interval yielded test material-related observations in the liver. In four of four high-dose males there was hepatocellular hypertrophy, occurring either centrilobullary or without regard to location within hepatic lobules. Hypertrophy, as described in the males, was observed in all high-dose females. The microscopic observations of hepatocellular hypertrophy were reflected in higher liver weights in the high-dose females. Hypertrophy was regarded as test material-dependent in high-dose animals. Centrilobular or diffuse hepatocellular vacuolation was also test material-dependent in high-dose animals, occurring in two of four females and two of four males. Multifocal hepatic vacuoles were not regarded as test material-dependent because they were found in one of four low-dose males, and in a control and a low-dose female. Microscopic examination of liver taken at biopsy on Week 57 from the high-dose animal did not have any test material-related findings. At the recovery sacrifice, one of two males and one of two females did not have macroscopic observations. The observations in the other animals were of adhesions on the lungs or liver and nodules in the thoracic cavity. None of these observations was considered test material-related. Only livers were examined microscopically, and no test material-related observations were made. The hepatic vacuolation observed in terminal sacrifice and unscheduled death animals was not present, indicating that the hepatic test material-related effects were reversible. 32 CONCLUSION Covance 6329-223 3M T-6295.7 Treatment with PFOS by oral capsule for at least 26 weeks is generally well-tolerated in male and female cynomolgus monkeys at doses up to 0.15 mg/kg/day. Clinical and pathological findings considered to be associated with the treatment of PFOS after at least 26 weeks of treatment were found to be reversible during a 52-week recovery period. Based on the data presented in this report, the no-observable-adverse-effect level is 0.15 mg/kg/day. Dose analysis results (provided by the Sponsor), fecal analysis results (provided by the Mayo Clinic), and electron microscopy results (provided by Pathology Associates), were provided for inclusion in the final report. 33 SIGNATURES Covance 6329-223 3M T-6295.7 34 Covance 6329-223 3M T-6295.7 REFERENCES Dunnett, C. W., "New Tables for Multiple Comparisons with a Control," Biometrics, 20:482-491 (1964). Levene, H., "Robust Tests for Equality of Variances," Contributions to Probability and Statistics, (eds.) I. Olkin et al., Ch. 25, pp. 278-292, Stanford University Press: Stanford, California (1960). Winer, B. J., "Design and Analysis of Single-Factor Experiments," Statistical Principles in Experimental Design, Second Ed., Ch. 3, pp. 149-260, McGraw-Hill: New York, New York (1971a). Winer, B. J., "Analysis of Covariance," Statistical Principles in Experimental Design, Second Ed., Ch. 10, pp. 752-812, McGraw-Hill: New York, New York (1971b). 35 OPHTHALMOLOGY REPORT Covance 6329-223 3M T-6295.7 Ophthalmic examinations were done before initiation of treatment and during Weeks 26 and 52. There were no ophthalmic observations at the Week 26 or Week 52 examinations that were test material-related. Animal No. I05529 (Group 1 female) was noted as having increased myelination of the right optic nerve at the baseline and Week 52 ophthalmic examinations. Because this is a permanent, congenital condition, it was noted at the baseline and recovery examinations only and is not related to treatment with PFOS. There were no test material-related observations at any of the examinations. 36 PATHOLOGY REPORT Covance 6329-223 3M T-6295.7 SUMMARY The purpose of the study was to assess the effect of the test material, Perfluorooctane Sulfonic Acid Potassium Salt (PFOS), on critical enzyme levels, hormones, and other selected biochemical parameters when administered daily by capsule to cynomolgus monkeys for at least 26 weeks. The test material was administered at dose levels of 0.03, 0.15, and 0.75 mg/kg/day. One male given 0.75 mg/kg/day died on Day 155 after dose administration and one male given 0.75 mg/kg/day was sacrificed on Day 179 due to poor health. The treatment period was followed by an approximate 52-week recovery period. Administration of PFOS was associated with moderately to markedly lower total cholesterol for males and females given 0.75 mg/kg/day and high density lipoprotein cholesterol for males and females given 0.15 or 0.75 mg/kg/day. During the treatment period, the effect on total cholesterol became progressively worse over time. The effect on cholesterol was reversed within 5 weeks of the end of treatment, and the effect on high density lipoprotein cholesterol was reversed within 9 weeks of the end of treatment. Of uncertain relationship to administration of PFOS was lower total bilirubin concentration for males given 0.75 mg/kg/day and higher serum bile acid concentration for males given 0.75 mg/kg/day. These potential effects of the test material were very mild, and neither was considered adverse. Two of four males receiving 0.75 mg/kg/day did not survive to the scheduled terminal sacrifice at Week 27. At the terminal sacrifice, females in the group receiving 0.75 mg/kg/day had increased absolute liver weight, liver-to-body weight percentages, and liver-to-brain weight ratios. In males, liver-to-body weight percentages were increased in the high-dose group compared to controls. These absolute and relative liver weight increases were regarded as test material-related. Among the macroscopic observations, only "mottled" liver was considered test material-related. "Mottled" livers were observed in the two high-dose males and in one high-dose female. Of the two males not surviving until the scheduled terminal sacrifice, one had "mottled" and "large" liver. 37 Covance 6329-223 3M T-6295.7 Microscopic examination of animals sacrificed at Week 27 and the two unscheduled sacrifice males yielded test material-related observations in the liver. In four of four high-dose males there was hepatocellular hypertrophy, occurring either centrilobullary or without regard to location within hepatic lobules. Hypertrophy, as described in the males, was also observed in four of four high-dose females. The microscopic observations of hepatocellular hypertrophy were reflected in higher liver weights in the high-dose females. Hypertrophy was regarded as test material-dependent in high-dose animals. Centrilobular or diffuse hepatocellular vacuolation was also test material-dependent in high-dose animals, occurring in two of four females and two of four males. Multifocal hepatic vacuoles were not regarded as test material-dependent because they were found in one of four low-dose males, and in a control and a low-dose female. Microscopic examination of liver taken at biopsy on Week 57 from the high-dose animal did not have any test material-related findings. For the recovery sacrifice at Week 79, only high-dose animals were necropsied. One of two males and one of two females did not have macroscopic observations. The observations in the other animals were of adhesions on the lungs or liver and nodules in the thoracic cavity. None of these observations was considered test material-related. Only livers were examined microscopically. No test material-related observations were made. The hepatic vacuolation observed in terminal sacrifice and unscheduled death animals was not present, indicating that the hepatic test material-related effects were reversible. METHODS Four groups of male and female cynomolgus monkeys were administered the test material daily by capsule at a dose level of 0 (control group; received capsules containing lactose), 0.03, 0.15, or 0.75 mg/kg of body weight/day (mg/kg/day). There were six animals/sex in the control group and the groups given 0.15 or 0.75 mg/kg/day; two animals/sex in these groups were designated as recovery animals to be observed for approximately 26 weeks posttreatment. The recovery period was later extended an additional 26 weeks. There were four animals/sex in the group given 0.03 mg/kg/day. 38 Covance 6329-223 3M T-6295.7 One male given 0.75 mg/kg/day died on Day 155 following dose administration, and one male given 0.75 mg/kg/day was sacrificed on Day 179 due to poor health. Blood and urine were collected for hematology, clinical chemistry, and urinalysis tests once before initiation of treatment (Week -4), on Days 37, 62, 91, 153, and 182 and on Days 217, 245, 274, 322, 364, 456, and 546 (recovery animals). High density lipoprotein cholesterol was not measured at the clinical pathology intervals before Day 153. The terminal sacrifice and necropsy occurred on Days 184/185; macroscopic observations were recorded, organ weights were obtained, and tissues were placed in fixative as specified by the protocol. Samples of the right lateral lobe of the liver from each animal were frozen for analysis of palmitoyl CoA oxidase activity. Sections of liver from each animal were processed to block for electron microscopy and shipped to the Sponsor's designee for ultrastructural evaluation. Samples of liver from each animal were frozen and shipped to the Sponsor for PFOS determination. The gallbladders and bile from each animal were collected, frozen, and shipped to the Sponsor. Samples of pancreas, left and right testes, and the left lateral lobe of the liver were preserved for cell proliferation evaluation by the Sponsor's designee using proliferation cell nuclear antigen. Light microscopic examinations were done on collected tissues from control animals and animals given 0.75 mg/kg/day. In addition, liver and thymus from all animals given 0.03 or 0.15 mg/kg/day and spinal cord gray matter from females given 0.03 or 0.15 mg/kg/day were examined by light microscopy. During Week 57, liver biopsies were performed on the recovery animals that had been given 0.75 mg/kg/day. The tissue was divided into four samples. Three of the samples were used for light microscopic examination, ultrastructural examination by the Sponsor's designee, and PFOS analysis by the Sponsor, respectively. The fourth sample was frozen and shipped to the Sponsor for possible analysis. At the end of the recovery period (Week 79), the control animals were returned to the Covance stock colony, the animals that had been given 0.15 mg/kg/day were transferred to a subsequent study for the Sponsor (Covance 6329-268) following liver biopsy for PFOS analysis by the Sponsor, and the animals that had been given 0.75 mg/kg/day were sacrificed and necropsied. At this recovery necropsy, macroscopic observations were recorded, and three samples of liver were collected for light microscopic examination, ultrastructural examination by the Sponsor's designee, and PFOS analysis by the Sponsor, respectively. 39 Covance 6329-223 3M T-6295.7 Statistically significant differences cited in the Results and Discussion are based on comparisons between the control and treated groups. RESULTS AND DISCUSSION Mortality Two of four males receiving 0.75 mg/kg/day (high dose) of the test material did not survive to the scheduled terminal sacrifice at Week 27. One was found dead on Day 155. The other was sacrificed on Day 179 due to poor health. The cause of death in the animal found dead was judged to be pulmonary necrosis with severe acute inflammation. Microscopically, the pulmonary lesion appeared to be an acute exacerbation of a chronic lesion. The cause of death in the moribund animal was not determined. All other animals survived to their scheduled sacrifices. Clinical Pathology Week -4. Results of clinical pathology tests indicated no obvious group or individual health abnormalities. Several animals, however, had mildly elevated alanine aminotransferase activities at Week -4. These animals were primarily females and were dispersed among all of the groups. By Day 37, their alanine aminotransferase activities were no longer elevated. The transient increase in this liver enzyme was considered likely due to subclinical infection with Hepatitis A virus, a common infection in cynomolgus monkeys, and did not negatively impact evaluation of the test material. Days 37, 62, 91, 153, and 182. Although there were several statistically significant or otherwise notable differences for clinical pathology test results between the control and treated animals, most of the differences were inconsistent over time or similar to differences present before initiation of treatment (i.e., Week -4). The only differences considered to represent effects of the test material were lower total cholesterol for males and females given 0.75 mg/kg/day and lower high density lipoprotein cholesterol for males and females given 0.15 or 0.75 mg/kg/day. The effect on total cholesterol became progressively worse over time. At Day 182, the mean total cholesterol concentrations for the males and females given 0.75 mg/kg/day were approximately 68% and 49% lower, respectively, than those for the control males and females. The effect on high density lipoprotein cholesterol, measured only at Days 153 and 182, was proportionately greater than that for total cholesterol. At Day 182, the mean high density lipoprotein cholesterol 40 Covance 6329-223 3M T-6295.7 concentrations for the males and females given 0.75 mg/kg/day were approximately 79% and 62% lower, respectively, than those for the control males and females. Of uncertain relationship to administration of PFOS was lower total bilirubin concentration for males given 0.75 mg/kg/day (statistically lower on Days 91, 153, and 182) and higher serum bile acid concentration for males given 0.75 mg/kg/day (statistically higher on Day 182 only). These potential effects of the test material were very mild, and neither was considered adverse. Statistically significant differences for other test results were considered incidental and unrelated to administration of the test material. These differences were inconsistent over time or were similar to differences that existed before the initiation of treatment. Unscheduled sacrifice Animal No. I05506, a male given 0.75 mg/kg/day, was sacrificed on Day 179. The most notable findings for this animal were a moderate neutrophilic leukocytosis, mildly increased serum bile acid and globulin concentrations, and moderately to markedly decreased total cholesterol and high density lipoprotein cholesterol. Days 217, 245, 274, 322, 364, 456, and 546 (Recovery animals). The effect on cholesterol was reversed by Day 217, and the effect on high density lipoprotein cholesterol was reversed by Day 245. There were no other findings considered to represent persistent or delayed occurrence of toxic effects. Anatomic Pathology Organ Weights. At the terminal sacrifice (Week 27) females in the group receiving 0.75 mg/kg/day (high-dose) had increased absolute liver weight, liver-to-body weight percentages, and liver-to-brain weight ratios. This increase was regarded as test material-related. In females the absolute pancreas weights were higher in animals receiving 0.03 mg/kg/day (low-dose) than in those receiving 0 mg/kg/day (control). Increased pancreatic weights were not regarded as test material-related. In males, liver-to-body weight percentages were increased in the high-dose group compared to controls. The increase was regarded as test material-related. Left adrenal-to-body weight percentages were also increased in high dose males compared to controls. The significance of the increase left adrenal weight percentage was not known. 41 Organ weights were not taken at the recovery sacrifice at Week 79. Covance 6329-223 3M T-6295.7 Macroscopic Observations. Twenty one of 30 animals at the terminal sacrifice had at least one macroscopic observation. One of the observations was obesity; it was not regarded as pathologic. Thus, 20 animals had macroscopic observations. Of all the macroscopic observations, only "mottled" liver was considered test material-related. "Mottled" liver was observed in the two high-dose males and in one high-dose female. The other observations included adhesions and dark or red foci in any of several organs. Among high-dose females, each had at least one observation of a dark or red focus. In addition, adrenal cortices of the two high-dose males and two of four high dose females were recorded as dark. In one high-dose female (Animal No. I05540), the red focus in the lung correlated microscopically with hemorrhage. There were no microscopic correlates for the other observations. Hence, dark or red foci were considered too non-specific to be considered test material-related. Additionally, dark and red foci were observed in animals in other dose groups. Dark adrenal cortices did not have a microscopic correlate; they, too, were not considered test material-related. Of the two males not surviving until the scheduled terminal sacrifice, one did not have any macroscopic observations. The other (Animal No. I05509) had several observations. Of these observations, those in the liver were considered test material-related. The liver observations were "mottled" and "large". For the recovery sacrifice at Week 79, only high dose animals were necropsied. One of two males and one of two females did not have macroscopic observations. The observations in the other animals were of adhesions on the lungs or liver and nodules in the thoracic cavity. None of these observations was considered test material-related. Microscopic Observations. At the terminal sacrifice, all tissues from the control and high dose groups were examined. All tissues were examined on the two high-dose males not surviving until the terminal sacrifice; the microscopic data were grouped with that of the terminal sacrifice animals. Liver, thymus, and spinal cord (females only) were examined from animals in the low and intermediate dose groups. In four of four high-dose males there was hepatocellular hypertrophy, occurring either centrilobullary or without regard to location within hepatic lobules. Hypertrophy, as described in the males, was observed in four of four high-dose females. The microscopic observations of 42 Covance 6329-223 3M T-6295.7 hepatocellular hypertrophy were reflected in higher liver weights in the high-dose females. Hypertrophy was regarded as test material-dependent in high dose animals. Centrilobular or diffuse hepatocellular vacuolation was also test material-dependent in high-dose animals, occurring in two of four females and two of four males. Multifocal hepatic vacuoles were not regarded as test material-dependent. Multifocal hepatic vacuoles were found in one of four low dose males, and in a control and a low-dose female. Two other observations were suggestive of possible test material effects upon examination of only control and high-dose animals. When tissues were examined from the low and intermediate dose groups as well, test material-dependency was not supported. In females, thymic atrophy was more pronounced in dosed animals than in controls. However, there is no clear dose-dependent pattern and thus, thymic atrophy cannot be considered test material-dependent. Intraneuronal pigment was observed in the spinal cord gray matter of two of four high dose, four of four mid-dose, three of four low-dose and one of four control females. And thus, spinal cord pigment was considered unrelated to the test material. Microscopic examination of liver taken at biopsy on Week 57 from the high-dose animal did not have any test material related findings. At the recovery sacrifice, livers were examined from high-dose animals. No test material-related observations were made. The hepatic vacuolation observed in terminal sacrifice and unscheduled death animals was not present, indicating that the hepatic test material-related effects were reversible. In those animals from which all tissues were examined, the width of the femoral growth plates were assessed as a general indication of the maturity of the animals. Based on this indicator, males were less mature than females. 43 Covance 6329-223 3M T-6295.7 44 Covance 6329-223 3M T-6295.7 COMMENTS ON THE DATA Various models of calculators, computers, and computer programs were used to analyze data in this study. Because different models round off or truncate numbers differently, values in some tables (e.g., means, standard deviations, or individual values) may differ slightly from those in other tables, from individually calculated data, or from statistical analysis data. Neither the integrity nor the interpretation of the data was affected by these differences. Some tabular data were compiled using Excel Version 7.0 software. The units for the dose levels on the data collection system (PTS) summary tables are mg/kg/day. The number of animals listed in the heading of the summary table for clinical observations reflects the number of animals assigned to each group at the start of the study. The summary table for clinical observations indicates the number of animals for which a condition was observed without regard to the specific nature, severity, reversibility, number of incidences/animal, or the length of time the condition persisted. Only observations other than normal are indicated on the summary of clinical observations table. The specific details for comments in the individual clinical observations tables that are indicated with a "C" can be found at the end of each group for each sex. The day of initiation of treatment is "Day 1, Week 1." Body weight data are entered at the start of a study week (e.g., a body weight recorded on Day 1 is considered a Week 1 body weight, a body weight recorded on Day 8 is considered a Week 2 body weight). Differences in the population size (N) on the summary tables for clinical and anatomic pathology are explained on the individual data tables. Results of clinical pathology samples collected for animals sacrificed at an unscheduled interval appear on the individual clinical pathology tables for the next scheduled interval. These results are not on the summary tables and are not included in the statistical analyses. Statistical analyses were not done when there were two or fewer values for a parameter. 45 Covance 6329-223 3M T-6295.7 COMMENTS ON THE DATA (continued) Bile volume is located on the individual anatomic pathology table under the heading of "absolute organ weight (grams)". The value listed for bile is not a weight and is designated with a unit of mL. Some clinical observations discussed in the report were documented on the Request for Veterinary Services form and will be archived with the raw data, but they do not appear on the individual clinical observations tables. 46 CODES, ABBREVIATIONS, AND UNITS Covance 6329-223 3M T-6295.7 General Codes and Abbreviations Codes for Clinical Pathology Abbreviations and Units for Clinical Hematology Abbreviations and Units for Clinical Chemistry Abbreviations and Units for Clinical Urinalysis Codes for Anatomic Pathology Note: The following lists of codes, abbreviations, and units are used by Covance. Some, but not necessarily all, of this information may be needed for this report. 47 General Codes and Abbreviations Covance 6329-223 3M T-6295.7 WK N Mean; MEAN CAM SD; S.D.; STAND DEV; STANDARD DEV; sd * -; NA P C UNSCHED DISPATCH TBW # VET EXAM AM OBS 30-90 OB E2 FSH LH T3 T4 FREE T4 TSH Week Number of measurements in a group Arithmetic mean Covariate-adjusted mean Standard deviation Group mean is significantly different from the mean of the control group (Group 1) at p < 0.05 No value; not applicable; not present Present Comment found at the end of each group for each sex Unscheduled Observations transferred from the in-life module of the data collection system to the necropsy module for reference during necropsy. Observations are duplicates of the last in-life observations. Terminal body weight Number Veterinary examination Observations recorded during the daily, morning observation interval. Observations recorded during the 30 to 90 minute postdose observation interval. Estradiol Follicle stimulating hormone Lutenizing hormone Triiodothyronine Total thyroxin Free thyroxin Thyroid stimulating hormone 48 NS QS/QNS NR FS SC SH H SL L SI I NF U DT/DOT DB TJ TE RE EE SE PC PD PI PL PA CO HB PLASMO NO AGG FR UTD NO COAG Covance 6329-223 3M T-6295.7 Codes for Clinical Pathology GENERAL CODES No sample Quantity not sufficient No repeat (sample volume not sufficient for repeat analysis) Fibrin strands Sample clotted Slightly hemolyzed Hemolyzed Slightly lipemic Lipemic Slightly icteric Icteric Animal not fasted Unscheduled/moribund bleed Animal died on test Died during bleeding Technician judgment to repeat test Technical error (instrument or technician error that results in unacceptable data, e.g., unacceptable instrument output, sample spilled, entry of invalid data) Recording error (recorded incorrect data, e.g., wrong number, spelling error, incorrect date) Entry error (incorrect keyboard entry) Sampling error Platelets clumped Platelets decreased Platelets increased Platelets large Platelets appear adequate Color interferes with test Heinz bodies observed Plasmodium No aggregation Fractious Unable to determine No coagulation 49 Covance 6329-223 3M T-6295.7 Codes for Clinical Pathology (Continued) RESULTS NOT INCLUDED IN STATISTICAL ANALYSES Hemolyzed clinical chemistry or coagulation samples Samples from animals at unscheduled intervals Prothrombin times (PT) greater than 50 seconds Activated partial thromboplastin times (PTT) greater than 110 seconds Bleed times (BLETIME) greater than 30 minutes CODES FOR BLOOD CELL MORPHOLOGY The following scale was used to measure the degree of anisocytosis (ANISO), poikilocytosis (POIK), polychromasia (POLY), hypochromasia (HYPO), and toxic neutrophils (TOXNEUT): Scale 1 2 3 4 Degree Normal for the species Slight Moderate Marked Not applicable Presence Not present Rare Few Moderate Many A Pale B Straw C Yellow D Dark yellow URINE APPEARANCE Color E Amber F Brown G Red H Green I Black P Blue/green Q Blue R Orange Clarity J Clear K Hazy L Cloudy Miscellaneous M Debris O Feces 50 Covance 6329-223 3M T-6295.7 Codes for Clinical Pathology (Continued) URINE CHEMISTRY MULTISTIX STRIP Urine Glucose + ++ +++ ++++ +++++ Negative 100 mg/dL 250 mg/dL 500 mg/dL 1,000 mg/dL >2,000 mg/dL Urine Ketone + ++ +++ ++++ +++++ Negative 5 mg/dL 15 mg/dL 40 mg/dL 80 mg/dL 160 mg/dL Urine Blood - Negative + Small ++ Moderate +++ Large Urine Urobilinogen + ++ +++ ++++ 0.2 mg/dL 1 mg/dL 2 mg/dL 4 mg/dL 8 mg/dL (1 mg = approximately 1 Ehrlich unit) Urine Bilirubin - Negative + Small ++ Moderate +++ Large URINE SEDIMENT Cells, Crystals, Casts, and Comments A Amorphous urates B Amorphous phosphates C Uric acid D Triple phosphates E Calcium oxalate F Calcium carbonate G Granular casts H Hyaline casts I Cellular casts J Waxy casts K Unknown crystal P Mucous threads Q Sperm R Fecal contamination S Pinworm ova found T Pinworm larvae found U Parasite ova found 0 Not present 1 1-5 per field 2 6-10 per field 3 11-20 per field 4 >20 per field Bacteria 0 Not present 1 Few 2 Moderate 3 Many 51 Covance 6329-223 3M T-6295.7 Abbreviations and Units for Clinical Hematology Test Red blood cell count Hemoglobin Hematocrit Mean corpuscular volume Mean corpuscular hemoglobin Mean corpuscular hemoglobin concentration Platelet count Mean platelet volume Reticulocyte count Absolute reticulocyte count Heinz body count Erythrocyte sedimentation rate Prothrombin time Activated partial thromboplastin time Thrombin time Activated coagulation time Fibrinogen Fibrin/fibrinogen degradation products Platelet aggregation Collagen Adenosine diphosphate Alpha 2-antiplasmin Bleeding time Methemoglobin Plasma hemoglobin Myeloid/erythroid ratio Estimated myeloid/erythroid ratio White blood cell count Differential blood cell count Nucleated red blood cell count Corrected white blood cell count Segmented neutrophil count Band neutrophil count Lymphocyte count Monocyte count Eosinophil count Basophil count Anisocytosis Polychromasia Poikilocytosis Abbreviation (Units) RBC (E6/UL or X106/mcL) HGB (G/DL) HCT (%) MCV (FL) MCH (PG) MCHC (%) PLT (E3/UL or X103/mcL) MPV (FL) RETIC (%) RETIC (E3/UL or X103/mcL) HEINZ (%) ESR (MM/HR) PT (SEC) PTT (SEC) TT (SEC) ACT (SEC) FBR (MG/DL) FDP (UG/ML) PAGG/COL (%) PAGG/ADP (%) ANTIPLAS (%) BLE TIME (SEC) METHGB (%) PLA HGB (MG/DL) M/E RATIO EST M/E RATIO WBC (E3/UL or X103/mcL) NRBC (/100 WBC) COR WBC (E3/UL or X103/mcL) N-SEG (E3/UL or X103/mcL) and % N-BAND (E3/UL or X103/mcL) and % LYMPH (E3/UL or X103/mcL) and % MONO (E3/UL or X103/mcL) and % EOSIN (E3/UL or X103/mcL) and % BASO (E3/UL or X103/mcL) and % ANISO (-,1,2,3) POLY (-,1,2,3) POIK (-,1,2,3) 52 Covance 6329-223 3M T-6295.7 Abbreviations and Units for Clinical Hematology (Continued) Test Hypochromasia Howell-Jolly bodies Basophilic stippling Toxic neutrophils Atypical lymphocytes Aqueous white blood cell count (right eye) Aqueous white blood cell count (left eye) Abbreviation (Units) HYPO (-,1,2,3) HJBODY (-,1,2,3,4) BASTIP (-,1,2,3) TOXNEUT (-,1,2,3,4) ATYPLYM (-,1,2,3,4) R EYE (WBC/UL) L EYE (WBC/UL) 53 Covance 6329-223 3M T-6295.7 Abbreviations and Units for Clinical Chemistry Test Glucose Urea nitrogen Urea Creatinine Total protein Albumin Globulin Albumin/globulin ratio Total bilirubin Direct bilirubin Indirect bilirubin Cholesterol Triglyceride Urea nitrogen/creatinine ratio Total lipids Phospholipids High-density lipoprotein cholesterol Low-density lipoprotein cholesterol Uric acid Aspartate aminotransferase Alanine aminotransferase Alkaline phosphatase Gamma glutamyl transferase Sorbitol dehydrogenase Lactate dehydrogenase Creatine kinase Amylase Lipase Palmitoyl CoA oxidase Calcium Ionized calcium Inorganic phosphorus Sodium Potassium Chloride Magnesium Zinc Strontium Iron Abbreviation (Units) GLU (MG/DL) UN (MG/DL) UREA (MG/DL) CREAT (MG/DL) T PRO (G/DL) ALB (G/DL) GLOB (G/DL) A/G RATIO T BILI (MG/DL) D BILI (MG/DL) I BILI (MG/DL) CHOL (MG/DL) TRIG (MG/DL) UN/CREAT (RATIO) T LIPIDS (MG/DL) P LIPIDS (MG/DL) HDL (MG/DL) LDL (MG/DL) UA (MG/DL) AST/SGOT (IU/L) ALT/SGPT (IU/L) ALK PHOS (IU/L) GGT (IU/L) SDH (IU/L) LDH (IU/L) CK (IU/L) AMYLASE (IU/L) LIPASE (IU/L) PCOAO (IU/G) CA (MG/DL) ION CA (MG/DL) I PHOS (MG/DL) NA (MMOL/L) K (MMOL/L) CL (MMOL/L) MG (MEQ/L or MG/DL) ZN (MG/L or PPM) SR (MG/L or PPM) FE (UG/DL) 54 Covance 6329-223 3M T-6295.7 Abbreviations and Units for Clinical Chemistry (Continued) Test Excess iron Total iron binding capacity Unbound iron binding capacity Percent iron saturation Plasma cholinesterase Red blood cell cholinesterase Brain cholinesterase Caudate putamen Hippocampus Frontal cortex Cerebellum Bicarbonate Serum hemoglobin Serum bile acids Fecal bile acids Average fecal weight Fecal bile acids (calculation) Osmolality Electrophoresis Albumin Alpha-1-globulin Alpha-2-globulin Beta globulin Gamma globulin High-density lipoprotein Low-density lipoprotein Very-low-density lipoprotein Insulin Adrenocorticotropic hormone Cortisol Glucagon Triiodothyronine Thyroxine Creatine kinase isoenzymes BB MB MM Abbreviation (Units) EX FE (UG/DL) TIBC (UG/DL) UIBC (UG/DL) FE %SAT (%) CHEP (MU/ML) CHER (MU/ML) CHEB (MU/ML) CAUD PUT (UMOL/G) HIPPOCAM (UMOL/G) F CORTEX (UMOL/G) CEREBELL (UMOL/G) BICARB (MMOL/L) SER HGB (MG/DL) SBA (UMOL/L or MG/DL) FBA (UG/ML) FCC WGT (G) FBA (MG/Day) OSMO (MOSM/KG) E ALB (G/DL) E A-1 (G/DL) E A-2 (G/DL) E BETA (G/DL) E GAMMA (G/DL) E-HDL (%) E-LDL (%) E-VLDL (%) INSULIN (UU/ML) ACTH (PG/ML) CORTISOL (UG/ML) GLUCAGON (PG/ML) T3 (NG/DL) T4 (UG/DL) CK-BB (U/L) CK-MB (U/L) CK-MM (U/L) 55 Covance 6329-223 3M T-6295.7 Abbreviations and Units for Clinical Urinalysis Test Urine volume 8 hour urine volume Specific gravity Urine osmolality Quantitative urinary/cerebrospinal fluid protein Urine protein excretion Urine chemistry Multistix strip Urine pH Urine protein Urine glucose Urine ketones Urine bilirubin Urine blood Urine urobilinogen Urine reducing substances Microscopic examination of urine sediment Red blood cells per high-power field White blood cells per high-power field Epithelial cells per high-power field Bacteria per high-power field Casts per low-power field Crystals per low-power field Urine appearance Comments Abbreviation (Units) U VOL (ML) 8 HR VOL (ML) SP GR U OSMO (MOSM/KG) QUAN PRO (MG/DL) PRO EXC (MG) U PH U PRO (MG/DL) U GLU U KET U BILI U BLOOD UROBILI U RE SUB RBC (PER HPF) WBC (PER HPF) EPITH (PER HPF) BACT (PER HPF) CASTS (PER LPF) CRYSTALS (PER LPF1 or PER LPF2) URINE APP1 or URINE APP2 COMMENTS Miscellaneous Codes and Abbreviations for Clinical Pathology Fecal occult blood Not applicable Fecal parasite detection Not applicable Hemolytic potential Not applicable 56 Code T U D M P/O 6 Codes for Anatomic Pathology Definition ANIMAL DEATH CODES Terminal sacrifice Recovery sacrifice Found dead Moribund Transferred to Covance stock Transferred to Covance 6329-268 Covance 6329-223 3M T-6295.7 EX NOT TAKEN MISSING UNSUITABLE AUTOLYTIC EXCLUDE MACROSCOPIC CODES Indicates that organ weight is excluded from calculations Organ weight not taken; explanation given in necropsy notes Organ missing or lost Organ technically unsuitable for weighing Organ autolyzed and could not be weighed Weight was taken, but was excluded from all calculations MICROSCOPIC CODES Codes Prefacing Neoplastic Findings B- Primary, benign neoplasm M- Primary, malignant neoplasm N- Metastatic neoplasm I- Locally invasive neoplasm X- Other neoplasm Distribution of Findings Focal Diffuse Multifocal 57 Covance 6329-223 3M T-6295.7 Codes for Anatomic Pathology (Continued) Code Definition Grades for Severity or Amount 1 Minimal - the least amount of change that can be observed with the light microscope 2 Slight - less than average amount of change, but readily discernible as abnormal 3 Moderate - the average amount of change that is expected for a lesion 4 Moderately severe (marked) - a marked amount of change with possible loss of function of the affected cells or organs 5 Severe - a great amount of change with probable loss of function of the affected cell or organs and frequently involves large areas of the organ Other Microscopic Codes TL Total P Finding present - Finding not present TISSUE ABBREVIATIONS Abbreviation LF RT LN GL STOMACH, GL STOMACH, NONGL SALIV GL, MANDIB LN, ANT MES/PANC AUDITORY SEB GL LACRIMAL GLAND, EX HEMATO NEOPLASIA LACRIMAL GL, INT CAVITY, ABDOM SALIV GL,PAROTID LN, TRACHEOBRON THYROID/PARA Definition Left Right Lymph node Gland Glandular stomach Nonglandular Mandibular salivary gland Anterior mesenteric/pancreatic lymph node Auditory sebaceous gland Exorbital lacrimal gland Hematopoietic neoplasia Internal lacrimal gland Abdominal cavity Parotid salivary gland Tracheobronchial lymph node Thyroid with parathyroid 58 59 60 Table 1 Covance 6329-223 3M T-6295.7 Summary of Clinical Observations Treatment PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED DAYS 1-185 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 6 4 6 6 6 4 6 6 ------------------------------------------------------------------------------------------------------------------------------------ *** TOP OF LIST *** APPEARANCE APPEARS DEHYDRATED 00011000 RECUMBENT 00010000 BEHAVIOR ATAXIC HYPOACTIVE 00010000 00021000 DISCHARGE NASAL CLEAR ORAL CLOUDY VOMITUS WHITE IN COLOR CONTAINING FOOD INTACT CAPSULE PARTIAL CAPSULE EXCESSIVE SALIVATION APPEARS TO BE MENSTRUATING 00001000 00001000 00000100 11312021 00001002 01033003 00011000 00004424 DISCHARGE UNKNOWN SOURCE FOUND IN PAN RED IN COLOR 10001000 61 Table 1 Covance 6329-223 3M T-6295.7 Summary of Clinical Observations Treatment PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED DAYS 1-185 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 6 4 6 6 6 4 6 6 ------------------------------------------------------------------------------------------------------------------------------------ EXCRETION DISCOLORED FECES BLACK IN COLOR RED IN COLOR YELLOW IN COLOR DISCOLORED URINE GREEN IN COLOR RED IN COLOR FEW FECES LIQUID FECES MUCOID FECES NO FECES NON-FORMED FECES SMALL FECES 00010000 00001003 00000001 00000001 00100000 00020235 11012002 00021002 00020111 32112102 00000001 EYES CONSTRICTED PUPIL EYES 00010000 RESPIRATION LABORED 00020000 SKIN & PELAGE ALOPECIA DORSAL DORSAL-THORACIC 00000001 00000001 62 Table 1 Covance 6329-223 3M T-6295.7 Summary of Clinical Observations Treatment PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED DAYS 1-185 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 6 4 6 6 6 4 6 6 ------------------------------------------------------------------------------------------------------------------------------------ SKIN & PELAGE ALOPECIA DORSAL-THORACIC-LEFT FEET HEAD-ENTIRE HEAD-CRANIAL HEAD-MAXILLARY-LEFT HEAD-MAXILLARY-RIGHT LIMB-HIND-LEFT LIMBS-ALL LIMBS-FRONT LIMBS-HIND TAIL BROKEN SKIN HAND-LEFT DIGIT(S)-FRONT-LEFT HEAD-CRANIAL HEAD-MAXILLARY-LEFT HEAD-MAXILLARY-RIGHT MOUTH PERI-ORBITAL-LEFT PERI-ORBITAL-RIGHT TAIL TAIL-DISTAL COLD TO TOUCH BODY-ENTIRE 00000001 00001000 00000001 00000001 00000001 00000001 00000001 00000002 00000001 00001000 00001001 10000000 00010000 00001010 00000100 00000100 00001000 00001101 01000210 10100000 10000000 00010000 63 Table 1 Covance 6329-223 3M T-6295.7 Summary of Clinical Observations Treatment PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED DAYS 1-185 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 6 4 6 6 6 4 6 6 ------------------------------------------------------------------------------------------------------------------------------------ SKIN & PELAGE PALE SKIN HEAD-ENTIRE GUMS RED SKIN LIMB-FRONT-RIGHT SCAB(S) HEAD-MAXILLARY-LEFT LIMB-FRONT-LEFT LIMB-FRONT-RIGHT BRUISED SKIN PERI-ORBITAL-LEFT 00000001 00010000 00001000 00000100 00001000 00001000 00000001 QUALITATIVE FOOD CONSUMPTION LOW *** END OF LIST *** 33665366 64 Table 2 Covance 6329-223 3M T-6295.7 Summary of Clinical Observations Recovery (Days 186 through 365) PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED DAYS 186-365 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 2 0 2 2 2 0 2 2 ------------------------------------------------------------------------------------------------------------------------------------ *** TOP OF LIST *** DISCHARGE APPEARS TO BE MENSTRUATING 00001011 EXCRETION FEW FECES LIQUID FECES NON-FORMED FECES 00000010 00001000 00100001 SKIN & PELAGE ALOPECIA FEET TAIL BROKEN SKIN DIGIT(S)-FRONT-LEFT 00001000 00001000 10000000 QUALITATIVE FOOD CONSUMPTION LOW *** END OF LIST *** 10212022 65 Table 3 Covance 6329-223 3M T-6295.7 Summary of Clinical Observations Recovery (Days 366 through 561) PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED DAYS 368-558 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 2 0 2 2 2 0 2 2 ------------------------------------------------------------------------------------------------------------------------------------ *** TOP OF LIST *** APPEARANCE SWOLLEN HEAD-MAXILLARY-RIGHT 00100000 DISCHARGE VOMITUS CONTAINING FOOD APPEARS TO BE MENSTRUATING 10201010 00001001 DISCHARGE UNKNOWN SOURCE FOUND IN PAN RED IN COLOR 00000011 EXCRETION FEW FECES LIQUID FECES NO FECES NON-FORMED FECES 00100020 00001001 00100020 10111001 SKIN & PELAGE ALOPECIA LIMB-HIND-RIGHT 00001000 66 Table 3 Covance 6329-223 3M T-6295.7 Summary of Clinical Observations Recovery (Days 366 through 561) PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED DAYS 368-558 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 2 0 2 2 2 0 2 2 ------------------------------------------------------------------------------------------------------------------------------------ QUALITATIVE FOOD CONSUMPTION LOW NONE *** END OF LIST *** 10212022 00000020 67 Table 4 Covance 6329-223 3M T-6295.7 Summary of Ophthalmic Observations Treatment PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED WEEK -4 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 6 4 6 6 6 4 6 6 ------------------------------------------------------------------------------------------------------------------------------------ *** TOP OF LIST *** NO VISIBLE LESIONS NO VISIBLE LESIONS EYE-LEFT 00001000 EYES 64665466 MISCELLANEOUS OPHTHALMICS INCREASED MYELINATION OF OPTIC NERVE EYE-RIGHT *** END OF LIST *** 00001000 68 Table 4 Covance 6329-223 3M T-6295.7 Summary of Ophthalmic Observations Treatment PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED WEEK 26 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 6 4 6 5 6 4 6 6 ------------------------------------------------------------------------------------------------------------------------------------ *** TOP OF LIST *** NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 64656466 *** END OF LIST *** 69 Table 5 Covance 6329-223 T-6295.7 Summary of Ophthalmic Observations Recovery PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED WEEK 52 SEX: -------MALE------- ------FEMALE------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 KEYWORD QUALIFIER NUMBER: 2 0 2 2 2 0 2 2 ------------------------------------------------------------------------------------------------------------------------------------ *** TOP OF LIST *** NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 20221022 EYE-LEFT 00001000 MISCELLANEOUS OPHTHALMICS INCREASED MYELINATION OF OPTIC NERVE EYE-RIGHT *** END OF LIST *** 00001000 70 Table 6 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Treatment 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 1 ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------------MALE--------------------- --------------------FEMALE-------------------- GROUP: 1 2 3 4 1 2 3 4 DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ -1a N MEAN S.D. 6 3.2 0.43 4 3.4 0.73 6 3.0 0.33 6 3.3 0.59 6 2.8 0.33 4 3.0 0.55 6 3.0 0.38 6 2.9 0.54 -1b N MEAN S.D. 6 3.3 0.45 4 3.4 0.65 6 3.1 0.34 6 3.4 0.55 6 2.8 0.29 4 3.0 0.55 6 3.0 0.41 6 2.9 0.52 1 N MEAN S.D. 6 3.3 0.45 4 3.4 0.70 6 3.1 0.35 6 3.4 0.55 6 2.8 0.29 4 3.1 0.60 6 3.0 0.41 6 2.9 0.52 2 N CAM MEAN S.D. 6 3.3 3.3 0.44 4 3.2 3.4 0.64 6 3.3 3.1 0.34 6 3.2 3.4 0.62 6 2.9 2.8 0.26 4 3.0 3.1 0.59 6 3.0 3.0 0.43 6 2.9 2.9 0.49 3 N CAM MEAN S.D. 6 3.3 3.3 0.41 4 3.3 3.4 0.68 6 3.3 3.2 0.32 6 3.3 3.4 0.59 6 2.9 2.8 0.38 4 3.0 3.1 0.59 6 2.9 3.0 0.43 6 2.9 2.9 0.49 4 N CAM MEAN S.D. 6 3.3 3.3 0.38 4 3.4 3.5 0.64 6 3.4 3.2 0.34 6 3.4 3.5 0.58 6 3.0 2.9 0.34 4 3.0 3.1 0.65 6 2.9 3.0 0.43 6 2.9 2.9 0.52 5 N CAM MEAN S.D. 6 3.3 3.3 0.39 4 3.4 3.5 0.64 6 3.4 3.2 0.34 6 3.4 3.5 0.60 6 2.9 2.8 0.35 4 2.9 3.1 0.60 6 2.9 3.0 0.44 6 2.8 2.8 0.55 a Day -7. b Day -1. 71 Table 6 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Treatment 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 2 ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------------MALE--------------------- --------------------FEMALE-------------------- GROUP: 1 2 3 4 1 2 3 4 DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 6 N CAM MEAN S.D. 6 3.3 3.3 0.41 4 3.4 3.5 0.63 6 3.4 3.2 0.34 6 3.4 3.5 0.60 6 2.9 2.8 0.36 4 3.0 3.1 0.57 6 2.9 3.0 0.48 6 2.8 2.8 0.55 7 N CAM MEAN S.D. 6 3.3 3.3 0.42 4 3.4 3.5 0.64 6 3.4 3.2 0.33 6 3.4 3.5 0.63 6 3.0 2.8 0.38 4 3.0 3.1 0.61 6 2.9 3.0 0.47 6 2.9 2.9 0.48 8 N CAM MEAN S.D. 6 3.3 3.3 0.39 4 3.4 3.5 0.64 6 3.3 3.2 0.30 6 3.4 3.5 0.65 6 2.9 2.8 0.39 4 3.0 3.1 0.61 6 2.9 3.0 0.47 6 2.9 2.9 0.50 9 N CAM MEAN S.D. 6 3.4 3.4 0.43 4 3.4 3.6 0.60 6 3.4 3.2 0.29 6 3.5 3.5 0.65 6 3.0 2.9 0.40 4 3.0 3.2 0.66 6 3.0 3.0 0.46 6 2.9 2.9 0.55 10 N CAM MEAN S.D. 6 3.4 3.4 0.43 4 3.4 3.6 0.60 6 3.3 3.2 0.33 6 3.4 3.5 0.65 6 3.0 2.9 0.36 4 3.0 3.1 0.62 6 3.0 3.0 0.44 6 2.9 2.9 0.55 11 N CAM MEAN S.D. 6 3.4 3.4 0.46 4 3.5 3.7 0.68 6 3.4 3.2 0.33 6 3.5 3.6 0.66 6 3.0 2.9 0.35 4 3.0 3.1 0.60 6 3.0 3.0 0.46 6 2.8* 2.8 0.51 12 N CAM MEAN S.D. 6 3.4 3.4 0.47 4 3.5 3.7 0.68 6 3.4 3.2 0.29 6 3.4 3.5 0.65 6 3.1 3.0 0.37 4 3.0 3.2 0.59 6 3.0 3.0 0.48 6 2.9* 2.9 0.50 72 Table 6 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Treatment 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 3 ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------------MALE--------------------- --------------------FEMALE-------------------- GROUP: 1 2 3 4 1 2 3 4 DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 13 N CAM MEAN S.D. 6 3.5 3.5 0.46 4 3.6 3.7 0.65 6 3.4 3.3 0.27 6 3.5 3.6 0.66 6 3.1 3.0 0.36 4 3.1 3.2 0.62 6 3.0 3.1 0.47 6 2.8* 2.8 0.46 14 N CAM MEAN S.D. 6 3.5 3.5 0.44 4 3.5 3.7 0.57 6 3.4 3.2 0.31 6 3.4 3.5 0.67 6 3.0 2.9 0.37 4 3.1 3.2 0.62 6 3.0 3.1 0.48 6 2.8* 2.8 0.44 15 N CAM MEAN S.D. 6 3.5 3.5 0.46 4 3.6 3.7 0.61 6 3.4 3.3 0.30 6 3.4 3.5 0.68 6 3.0 2.9 0.38 4 3.1 3.2 0.63 6 3.1 3.1 0.49 6 2.8* 2.8 0.38 16 N CAM MEAN S.D. 6 3.4 3.4 0.48 4 3.6 3.8 0.60 6 3.4 3.3 0.27 6 3.3 3.4 0.71 6 3.0 2.9 0.34 4 3.1 3.2 0.63 6 3.0 3.1 0.45 6 2.8* 2.8 0.38 17 N CAM MEAN S.D. 6 3.5 3.5 0.49 4 3.7 3.8 0.56 6 3.4 3.3 0.26 6 3.4 3.5 0.75 6 3.1 3.0 0.37 4 3.1 3.2 0.70 6 3.1 3.1 0.45 6 2.9 2.9 0.44 18 N CAM MEAN S.D. 6 3.5 3.5 0.50 4 3.6 3.7 0.56 6 3.4 3.3 0.23 6 3.4 3.5 0.69 6 3.1 2.9 0.38 4 3.1 3.2 0.68 6 3.0 3.1 0.48 6 2.9 2.9 0.45 19 N CAM MEAN S.D. 6 3.6 3.6 0.50 4 3.7 3.8 0.59 6 3.5 3.3 0.19 6 3.4 3.5 0.73 6 3.1 3.0 0.34 4 3.1 3.3 0.66 6 3.1 3.1 0.50 6 2.9* 2.9 0.39 73 Table 6 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Treatment 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 4 ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------------MALE--------------------- --------------------FEMALE-------------------- GROUP: 1 2 3 4 1 2 3 4 DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 20 N CAM MEAN S.D. 6 3.5 3.5 0.53 4 3.7 3.8 0.59 6 3.5 3.3 0.22 6 3.3 3.4 0.73 6 3.1 3.0 0.34 4 3.1 3.2 0.67 6 3.1 3.2 0.48 6 2.8* 2.8 0.38 21 N CAM MEAN S.D. 6 3.6 3.6 0.55 4 3.6 3.8 0.64 6 3.4 3.2 0.26 6 3.2 3.3 0.72 6 3.0 2.9 0.34 4 3.1 3.2 0.70 6 3.0 3.0 0.46 6 2.8* 2.8 0.33 22 N CAM MEAN S.D. 6 3.6 3.6 0.56 4 3.7 3.8 0.56 6 3.5 3.3 0.25 6 3.3 3.4 0.62 6 3.1 3.0 0.37 4 3.1 3.2 0.68 6 3.1 3.1 0.44 6 2.8* 2.8 0.31 23 N CAM MEAN S.D. 6 3.6 3.6 0.58 4 3.7 3.8 0.55 6 3.5 3.3 0.25 6 3.2* 3.3 0.67 6 3.0 2.9 0.31 4 3.1 3.2 0.68 6 3.1 3.1 0.46 6 2.8* 2.8 0.35 24 N CAM MEAN S.D. 6 3.6 3.6 0.63 4 3.7 3.9 0.60 6 3.5 3.3 0.26 5 3.3 3.4 0.69 6 3.0 2.9 0.32 4 3.1 3.2 0.76 6 3.1 3.1 0.46 6 2.8 2.8 0.32 25 N CAM MEAN S.D. 6 3.7 3.7 0.61 4 3.8 3.9 0.55 6 3.6 3.4 0.20 5 3.3 3.5 0.72 6 3.1 3.0 0.37 4 3.2 3.3 0.76 6 3.1 3.2 0.46 6 2.8* 2.8 0.31 26 N CAM MEAN S.D. 6 3.7 3.7 0.67 4 3.8 3.9 0.55 6 3.5 3.3 0.20 5 3.3 3.4 0.73 6 3.1 3.0 0.37 4 3.1 3.2 0.79 6 3.1 3.1 0.46 6 2.8* 2.8 0.35 74 Table 6 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Treatment 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 5 ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------------MALE--------------------- --------------------FEMALE-------------------- GROUP: 1 2 3 4 1 2 3 4 DOSE: 0 0.03 0.15 0.75 0 0.03 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 27 N CAM MEAN S.D. 6 3.7 3.7 0.68 4 3.8 3.9 0.56 6 3.5 3.3 0.26 4 3.0* 3.2 0.83 6 3.1 3.0 0.35 4 3.1 3.2 0.72 6 3.0 3.1 0.51 6 2.8* 2.8 0.37 75 Table 7 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Recovery PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------MALE--------------- --------------FEMALE-------------- GROUP: 1 3 4 1 3 4 DOSE: 0 0.15 0.75 0 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 28 N MEAN S.D. 2 3.5 0.42 2 3.1 0.21 2 3.1 0.57 2 2.7 0.35 2 3.3 0.71 2 2.6 0.14 29 N MEAN S.D. 2 3.6 0.42 2 3.1 0.28 2 3.3 0.64 2 2.7 0.42 2 3.4 0.71 2 2.7 0.14 30 N MEAN S.D. 2 3.6 0.42 2 3.0 0.28 2 3.3 0.57 2 2.7 0.35 2 3.3 0.71 2 2.7 0.14 31 N MEAN S.D. 2 3.7 0.42 2 3.1 0.35 2 3.5 0.71 2 2.7 0.42 2 3.4 0.78 2 2.8 0.21 32 N MEAN S.D. 2 3.8 0.42 2 3.2 0.35 2 3.6 0.85 2 2.8 0.35 2 3.5 0.78 2 2.9 0.35 33 N MEAN S.D. 2 3.8 0.42 2 3.2 0.28 2 3.7 0.78 2 2.8 0.42 2 3.5 0.78 2 3.0 0.28 34 N MEAN S.D. 2 3.8 0.42 2 3.2 0.21 2 3.8 0.99 2 2.8 0.35 2 3.4 0.85 2 3.0 0.28 76 Table 7 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Recovery PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------MALE--------------- --------------FEMALE-------------- GROUP: 1 3 4 1 3 4 DOSE: 0 0.15 0.75 0 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 35 N MEAN S.D. 2 3.8 0.35 2 3.1 0.28 2 3.7 0.99 2 2.8 0.35 2 3.5 0.92 2 3.0 0.21 36 N MEAN S.D. 2 3.8 0.42 2 3.3 0.21 2 3.9 1.06 2 2.8 0.35 2 3.6 0.92 2 3.1 0.35 37 N MEAN S.D. 2 3.9 0.42 2 3.2 0.28 2 3.9 1.06 2 2.8 0.42 2 3.6 0.78 2 3.1 0.35 38 N MEAN S.D. 2 3.9 0.42 2 3.2 0.21 2 3.8 0.99 2 2.8 0.35 2 3.5 0.85 2 3.0 0.42 39 N MEAN S.D. 2 3.9 0.35 2 3.1 0.28 2 3.7 0.99 2 2.7 0.42 2 3.5 0.85 2 2.9 0.35 40 N MEAN S.D. 2 3.9 0.35 2 3.1 0.28 2 3.7 1.06 2 2.6 0.42 2 3.4 0.85 2 3.0 0.21 41 N MEAN S.D. 2 4.0 0.42 2 3.3 0.21 2 3.8 0.99 2 2.8 0.42 2 3.6 0.85 2 3.1 0.35 77 Table 7 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Recovery PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------MALE--------------- --------------FEMALE-------------- GROUP: 1 3 4 1 3 4 DOSE: 0 0.15 0.75 0 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 42 N MEAN S.D. 2 4.0 0.28 2 3.2 0.21 2 3.8 1.06 2 2.7 0.42 2 3.6 0.78 2 2.9 0.35 43 N MEAN S.D. 2 4.0 0.28 2 3.2 0.21 2 3.8 0.99 2 2.7 0.42 2 3.6 0.78 2 3.0 0.42 44 N MEAN S.D. 2 4.2 0.28 2 3.3 0.21 2 3.8 0.92 2 2.8 0.35 2 3.7 0.92 2 3.1 0.35 45 N MEAN S.D. 2 4.3 0.21 2 3.3 0.28 2 3.8 0.92 2 2.8 0.42 2 3.7 0.78 2 3.1 0.35 46 N MEAN S.D. 2 4.4 0.21 2 3.3 0.28 2 4.0 0.92 2 2.8 0.42 2 3.6 0.85 2 3.1 0.42 47 N MEAN S.D. 2 4.2 0.14 2 3.2 0.28 2 3.8 0.85 2 2.7 0.42 2 3.6 0.92 2 3.1 0.49 48 N MEAN S.D. 2 4.2 0.18 2 3.2 0.25 2 3.9 0.78 2 2.6 0.35 2 3.6 0.94 2 3.1 0.49 78 Table 7 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Recovery PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------MALE--------------- --------------FEMALE-------------- GROUP: 1 3 4 1 3 4 DOSE: 0 0.15 0.75 0 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 49 N MEAN S.D. 2 4.3 0.21 2 3.3 0.21 2 4.1 0.78 2 2.8 0.35 2 3.7 0.92 2 3.2 0.35 50 N MEAN S.D. 2 4.3 0.21 2 3.2 0.28 2 4.0 0.71 2 2.7 0.35 2 3.6 0.92 2 3.1 0.35 51 N MEAN S.D. 2 4.3 0.21 2 3.3 0.21 2 4.1 0.64 2 2.7 0.42 2 3.7 0.92 2 3.1 0.35 52 N MEAN S.D. 2 4.4 0.21 2 3.3 0.21 2 4.1 0.57 2 2.7 0.28 2 3.7 0.92 2 3.1 0.42 53 N MEAN S.D. 2 4.4 0.21 2 3.2 0.28 2 4.1 0.49 2 2.6 0.28 2 3.6 0.99 2 3.1 0.49 54 N MEAN S.D. 2 4.4 0.28 2 3.3 0.21 2 4.2 0.49 2 2.6 0.28 2 3.6 0.92 2 3.1 0.49 55 N MEAN S.D. 2 4.5 0.28 2 3.3 0.21 2 4.1 0.42 2 2.7 0.35 2 3.5 0.99 2 3.1 0.64 79 Table 7 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Recovery PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------MALE--------------- --------------FEMALE-------------- GROUP: 1 3 4 1 3 4 DOSE: 0 0.15 0.75 0 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 56 N 2 2 2 2 2 2 MEAN 4.4 3.3 4.1 2.7 3.6 3.1 S.D. 0.35 0.14 0.35 0.35 0.92 0.57 57 N MEAN S.D. 2 4.4 0.35 2 3.3 0.21 2 4.0 0.28 2 2.6 0.35 2 3.6 0.92 2 3.0 0.57 58 N MEAN S.D. 2 4.4 0.35 2 3.3 0.14 2 4.1 0.35 2 2.7 0.28 2 3.6 0.78 2 3.0 0.57 59 N MEAN S.D. 2 4.4 0.42 2 3.3 0.14 2 4.1 0.42 2 2.7 0.35 2 3.5 0.71 2 3.0 0.57 60 N MEAN S.D. 2 4.6 0.49 2 3.4 0.14 2 4.3 0.42 2 2.8 0.35 2 3.6 0.85 2 3.2 0.49 61 N MEAN S.D. 2 4.6 0.49 2 3.4 0.14 2 4.3 0.42 2 2.7 0.28 2 3.6 0.78 2 3.2 0.49 62 N MEAN S.D. 2 4.5 0.49 2 3.5 0.21 2 4.4 0.49 2 2.7 0.42 2 3.6 0.78 2 3.2 0.57 80 Table 7 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Recovery PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------MALE--------------- --------------FEMALE-------------- GROUP: 1 3 4 1 3 4 DOSE: 0 0.15 0.75 0 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 63 N MEAN S.D. 2 4.5 0.57 2 3.4 0.14 2 4.4 0.42 2 2.8 0.35 2 3.6 0.71 2 3.2 0.57 64 N MEAN S.D. 2 4.4 0.64 2 3.4 0.14 2 4.5 0.21 2 2.7 0.35 2 3.6 0.78 2 3.2 0.64 65 N MEAN S.D. 2 4.4 0.57 2 3.4 0.07 2 4.4 0.21 2 2.7 0.35 2 3.5 0.78 2 3.1 0.57 66 N MEAN S.D. 2 4.4 0.64 2 3.3 0.14 2 4.3 0.28 2 2.6 0.28 2 3.5 0.78 2 3.1 0.57 67 N MEAN S.D. 2 4.5 0.57 2 3.4 0.14 2 4.4 0.21 2 2.7 0.35 2 3.6 0.71 2 3.2 0.57 68 N MEAN S.D. 2 4.6 0.57 2 3.5 0.21 2 4.5 0.21 2 2.7 0.35 2 3.6 0.78 2 3.2 0.64 69 N MEAN S.D. 2 4.7 0.57 2 3.5 0.14 2 4.5 0.28 2 2.7 0.28 2 3.6 0.85 2 3.2 0.71 81 Table 7 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Recovery PAGE: 7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------MALE--------------- --------------FEMALE-------------- GROUP: 1 3 4 1 3 4 DOSE: 0 0.15 0.75 0 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 70 N MEAN S.D. 2 4.6 0.57 2 3.5 0.07 2 4.5 0.21 2 2.7 0.35 2 3.6 0.78 2 3.2 0.71 71 N MEAN S.D. 2 4.7 0.64 2 3.5 0.07 2 4.4 0.28 2 2.7 0.35 2 3.6 0.85 2 3.2 0.71 72 N MEAN S.D. 2 4.8 0.71 2 3.6 0.07 2 4.5 0.21 2 2.7 0.35 2 3.7 0.78 2 3.3 0.78 73 N MEAN S.D. 2 4.7 0.71 2 3.5 0.07 2 4.4 0.21 2 2.7 0.35 2 3.6 0.85 2 3.2 0.78 74 N MEAN S.D. 2 4.8 0.85 2 3.6 0.07 2 4.5 0.21 2 2.7 0.42 2 3.7 0.78 2 3.3 0.78 75 N MEAN S.D. 2 4.8 0.78 2 3.6 0.07 2 4.5 0.21 2 2.7 0.28 2 3.7 0.78 2 3.3 0.78 76 N MEAN S.D. 2 4.8 0.85 2 3.6 0.07 2 4.5 0.21 2 2.7 0.28 2 3.7 0.71 2 3.4 0.78 82 Table 7 Covance 6329-223 3M T-6295.7 Summary of Body Weight Data (kg) Recovery PAGE: 8 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ SEX: ---------------MALE--------------- --------------FEMALE-------------- GROUP: 1 3 4 1 3 4 DOSE: 0 0.15 0.75 0 0.15 0.75 WEEK UNITS: MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY MG/KG/DAY ------------------------------------------------------------------------------------------------------------------------------------ 77 N MEAN S.D. 2 4.7 0.85 2 3.5 0.07 2 4.4 0.14 2 2.7 0.35 2 3.7 0.78 2 3.3 0.78 78 N MEAN S.D. 2 4.7 0.92 2 3.5 0.07 2 4.4 0.14 2 2.6 0.28 2 3.5 0.85 2 3.2 0.85 79 N MEAN S.D. 2 4.7 0.92 2 3.5 0.00 2 4.4 0.07 2 2.7 0.35 2 3.6 0.85 2 3.3 0.85 80 N 0 2 0 0 2 0 MEAN 3.3 3.4 S.D. 0.21 0.85 83 Table 8 Summary of Clinical Hematology Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.45 12.2 41.2 63.9 19.0 29.8 530 .3 S.D. .275 .36 1.30 2.32 .87 .56 125.0 .19 N 6 6 6 6 6 6 6 6 20 12.6 6 0.03 MEAN 6.99 12.4 42.9 61.5 17.8 29.0 574 .4 S.D. .688 .46 2.95 2.51 1.13 1.34 210.3 .24 N 4 4 4 4 4 4 4 4 24 14.9 4 0.15 MEAN 6.76 12.6 42.9 63.5 18.7 29.5 493 .5 S.D. .315 .41 1.88 2.38 .76 .41 109.0 .53 N 6 6 6 6 6 6 6 6 32 34.5 6 0.75 MEAN 6.88 12.5 43.1 62.8 18.2 29.0 415 .5 S.D. .575 .82 2.06 3.44 1.01 .61 202.6 .47 N 6 6 6 6 6 6 6 6 33 27.8 6 84 Table 8 Summary of Clinical Hematology Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 8.6 3.9 4.0 .6 .1 .0 44 47 7 1 0 S.D. 1.76 1.28 .90 .24 .08 .05 8.9 9.2 2.4 .8 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 11.0 5.2 4.6 .8 .2 .0 47 43 8 2 0 S.D. 1.00 1.88 1.05 .48 .17 .00 15.2 9.4 4.4 1.3 .0 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 11.9 6.6 4.1 .9 .2 .0 54 36 8 2 0 S.D. 1.95 2.42 1.14 .25 .31 .04 13.4 10.9 3.3 2.1 .4 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 9.4 3.7 4.3 1.1 .2 .1 39 46 12 2 1 S.D. 2.53 1.40 1.25 .53 .25 .08 10.9 9.5 3.3 3.3 .8 N 6 6 6 6 6 6 6 6 6 6 6 85 Table 8 Summary of Clinical Hematology Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.09 12.0 39.3 64.7 19.7 30.4 539 .6 S.D. .681 .97 3.93 4.51 1.81 .87 79.5 .46 N 6 6 6 6 6 6 6 6 35 24.2 6 0.03 MEAN 6.31 11.5 39.5 62.7 18.3 29.2 482 .4 S.D. .522 1.06 3.26 4.49 1.73 .71 72.4 .31 N 4 4 4 4 4 4 4 4 27 17.1 4 0.15 MEAN 6.54 12.0 40.1 61.4 18.3 29.8 481 .4 S.D. .320 .49 1.97 2.79 .50 .68 100.9 .26 N 6 6 6 6 6 6 6 6 29 16.2 6 0.75 MEAN 6.50 12.1 41.5 63.9 18.7 29.2 435 .2 S.D. .195 .50 1.68 1.14 .50 .52 108.9 .18 N 6 6 6 6 6 6 6 6 16 11.4 6 86 Table 8 Summary of Clinical Hematology Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 10.2 4.6 4.5 .8 .3 .0 45 44 7 3 0 S.D. 2.52 1.14 1.36 .24 .28 .05 8.3 7.6 1.2 2.1 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 8.7 5.0 2.9 .6 .1 .0 55 35 8 2 0 S.D. 2.41 2.52 .79 .17 .05 .05 14.3 11.6 2.8 .6 .5 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 10.1 5.1 3.8 .8 .3 .0 48 40 9 3 0 S.D. 2.94 2.81 .40 .20 .27 .04 13.0 8.4 3.8 3.0 .4 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 9.0 4.8 3.2 .8 .1 .0 54 35 9 1 0 S.D. 3.08 1.70 1.66 .32 .18 .04 10.7 9.7 4.2 1.4 .4 N 6 6 6 6 6 6 6 6 6 6 6 87 Table 9 Summary of Clinical Hematology Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.45 12.4 40.6 63.0 19.1 30.4 486 .2 S.D. .221 .55 1.44 2.74 .97 .58 117.8 .16 N 6 6 6 6 6 6 6 6 14 10.4 6 0.03 MEAN 6.86 12.5 42.4 61.9 18.2 29.5 532 .4 S.D. .501 .38 3.93 4.61 1.17 1.69 146.1 .35 N 4 4 4 4 4 4 4 4 29 23.8 4 0.15 MEAN 6.66 12.5 41.2 62.0 18.8 30.3 476 .4 S.D. .385 .27 .76 2.96 1.06 .53 59.6 .14 N 6 6 6 6 6 6 6 6 25 10.5 6 0.75 MEAN 6.53 11.8 40.2 61.7 18.1 29.4 383 .4 S.D. .431 .57 1.74 2.63 .85 .57 164.3 .10 N 6 6 6 6 6 6 6 6 25 5.9 6 88 Table 9 Summary of Clinical Hematology Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 7.6 3.9 3.1 .5 .0 .0 50 43 7 1 0 S.D. 1.98 2.01 .67 .31 .08 .08 14.4 12.8 3.4 1.2 .8 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 10.8 6.3 3.7 .5 .2 .0 58 36 5 2 0 S.D. 1.89 2.40 1.26 .17 .05 .00 15.9 14.2 1.7 .5 .0 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 10.0 6.0 3.2 .6 .2 .0 58 33 6 2 0 S.D. 2.06 2.23 .91 .24 .32 .05 12.5 10.4 3.6 2.3 .4 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 10.3 6.6 2.9 .6 .1 .0 62 30 7 1 1 S.D. 4.16 3.69 .52 .18 .11 .05 9.8 7.5 2.7 1.2 .4 N 6 6 6 6 6 6 6 6 6 6 6 89 Table 9 Summary of Clinical Hematology Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.41 12.2 40.5 63.1 19.0 30.2 538 .3 S.D. .351 .69 2.42 2.31 .83 .29 84.2 .16 N 6 6 6 6 6 6 6 6 22 10.8 6 0.03 MEAN 6.60 11.8 40.6 61.8 18.1 29.2 417 .3 S.D. .664 .97 2.92 6.28 1.80 .48 23.6 .28 N 4 4 4 4 4 4 4 4 18 15.6 4 0.15 MEAN 6.55 11.8 39.7 60.7 18.1 29.7 431 .3 S.D. .343 .41 1.06 2.68 .75 .29 85.3 .12 N 6 6 6 6 6 6 6 6 19 8.0 6 0.75 MEAN 6.21 11.6 39.1 63.0 18.6 29.6 469 .3 S.D. .280 .38 1.96 1.48 .44 .89 95.4 .23 N 6 6 6 6 6 6 6 6 20 13.1 6 90 Table 9 Summary of Clinical Hematology Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 12.7 7.8 3.6 1.1 .3 .0 59 30 8 2 0 S.D. 4.75 3.77 1.59 .67 .26 .08 18.2 16.2 2.3 1.7 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 9.6 5.7 2.8 .8 .2 .0 60 29 8 3 0 S.D. 2.37 1.90 .82 .24 .17 .05 10.6 6.0 2.1 2.2 1.0 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 9.1 5.5 2.9 .5 .2 .0 56 35 6 3 0 S.D. 2.66 2.48 .72 .13 .18 .00 17.0 15.7 1.6 1.2 .0 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 8.9 5.3 2.9 .6 .1 .0 56 35 7 1 0 S.D. 2.85 3.19 1.06 .20 .08 .00 15.1 13.7 2.7 1.2 .4 N 6 6 6 6 6 6 6 6 6 6 6 91 Table 10 Summary of Clinical Hematology Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.49 12.5 41.1 63.3 19.2 30.4 522 .3 S.D. .292 .53 1.78 3.03 .95 .84 126.9 .27 N 6 6 6 6 6 6 6 6 18 17.3 6 0.03 MEAN 6.84 12.4 41.4 60.7 18.2 29.9 536 .4 S.D. .437 .33 1.36 2.92 .91 .62 152.1 .45 N 4 4 4 4 4 4 4 4 25 29.6 4 0.15 MEAN 6.60 12.5 40.7 61.7 18.9 30.6 504 .3 S.D. .315 .52 1.42 2.56 .87 .50 97.3 .25 N 6 6 6 6 6 6 6 6 21 17.3 6 0.75 MEAN 6.73 12.3 41.2 61.3 18.3 29.8 437 .3 S.D. .516 .75 2.31 3.02 .72 .52 217.8 .19 N 6 6 6 6 6 6 6 6 19 12.6 6 92 Table 10 Summary of Clinical Hematology Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 7.3 3.0 3.5 .6 .1 .0 42 48 8 2 0 S.D. .81 .68 .87 .26 .08 .05 10.5 8.2 3.2 .8 .8 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 10.5 6.1 * 3.4 .8 .2 .0 58 32 8 2 0 S.D. 1.79 1.51 .82 .38 .05 .00 9.5 6.5 3.5 .5 .0 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 11.8 * 7.0 * 3.9 .7 .2 .0 56 35 7 2 0 S.D. 3.02 3.16 1.18 .40 .13 .05 16.3 14.6 4.0 .8 .4 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 9.6 5.3 3.4 .6 .2 .0 52 38 6 2 0 S.D. 2.97 2.52 .52 .23 .21 .08 10.0 11.2 1.0 2.1 .5 N 6 6 6 6 6 6 6 6 6 6 6 93 Table 10 Summary of Clinical Hematology Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.23 12.3 40.2 64.9 19.9 30.6 572 .4 S.D. .766 .66 3.27 4.33 1.87 1.01 74.6 .22 N 6 6 6 6 6 6 6 6 27 11.2 6 0.03 MEAN 6.48 12.0 40.2 62.4 18.5 29.7 462 .4 S.D. .593 .83 2.39 6.25 2.02 .67 83.8 .37 N 4 4 4 4 4 4 4 4 28 24.1 4 0.15 MEAN 7.00 12.8 42.3 60.5 18.3 30.3 436 .4 S.D. 1.068 2.17 6.70 2.31 .76 .57 133.5 .28 N 6 6 6 6 6 6 6 6 24 18.2 6 0.75 MEAN 6.28 11.8 40.2 64.0 18.9 29.5 504 .3 S.D. .397 .29 1.96 1.27 .72 .70 148.3 .25 N 6 6 6 6 6 6 6 6 17 14.9 6 94 Table 10 Summary of Clinical Hematology Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 11.1 5.8 4.3 .6 .3 .0 50 40 6 2 0 S.D. 2.93 3.08 1.73 .48 .18 .08 17.6 15.9 4.6 2.0 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 8.7 4.4 3.4 .6 .2 .0 50 40 8 2 0 S.D. 1.42 1.59 1.16 .13 .17 .06 14.5 14.9 .5 1.7 .6 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 8.8 4.3 3.6 .5 .3 .0 48 42 6 3 0 S.D. 1.78 1.75 .93 .16 .15 .05 13.1 11.2 2.9 1.6 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 9.3 5.6 3.0 .6 .1 .0 56 36 7 1 0 S.D. 4.59 3.89 1.07 .40 .08 .05 13.2 14.2 2.7 1.0 .4 N 6 6 6 6 6 6 6 6 6 6 6 95 Table 11 Summary of Clinical Hematology Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.43 12.4 40.3 62.8 19.3 30.7 490 .3 S.D. .314 .53 2.17 3.11 1.06 1.00 124.3 .26 N 6 6 6 6 6 6 6 6 21 16.4 6 0.03 MEAN 7.00 12.7 42.5 61.0 18.2 29.8 512 .7 S.D. .628 .55 1.78 3.13 1.02 .43 208.8 .54 N 4 4 4 4 4 4 4 4 47 33.7 4 0.15 MEAN 6.50 12.3 40.4 62.1 19.0 30.6 496 .5 S.D. .295 .16 .93 2.53 .76 .49 82.6 .54 N 6 6 6 6 6 6 6 6 33 32.0 6 0.75 MEAN 6.66 12.2 41.0 61.6 18.2 29.6 * 431 .4 S.D. .488 .81 2.23 2.47 .77 .65 198.6 .19 N 6 6 6 6 6 6 6 6 26 11.8 6 96 Table 11 Summary of Clinical Hematology Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.7 2.4 3.7 .4 .1 .0 37 55 6 2 0 S.D. 1.99 .64 1.24 .16 .08 .04 4.1 2.8 2.1 1.3 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 8.5 4.4 3.3 .6 .2 .0 50 40 * 7 2 0 S.D. 1.60 1.79 .88 .00 .10 .00 13.9 12.6 1.0 1.4 .0 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 10.3 5.7 * 3.7 .6 .2 .0 56 * 36 * 7 2 0 S.D. 3.21 1.85 1.61 .27 .18 .05 9.3 8.4 2.6 1.8 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 9.4 5.1 * 3.5 .6 .2 .0 52 * 38 * 6 2 0 S.D. 2.56 2.06 .71 .28 .16 .05 9.8 7.8 3.2 1.6 .5 N 6 6 6 6 6 6 6 6 6 6 6 97 Table 11 Summary of Clinical Hematology Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.31 12.3 40.3 64.1 19.5 30.4 562 .3 S.D. .565 .77 2.79 3.90 1.21 .33 83.6 .08 N 6 6 6 6 6 6 6 6 20 5.7 6 0.03 MEAN 6.20 11.7 39.2 63.6 19.0 29.9 467 .5 S.D. .472 .97 2.18 7.19 2.78 1.21 33.4 .13 N 4 4 4 4 4 4 4 4 30 7.9 4 0.15 MEAN 6.50 12.0 39.4 60.7 18.6 30.6 442 .2 S.D. .298 .42 1.44 2.35 .78 .57 78.9 .10 N 6 6 6 6 6 6 6 6 14 6.6 6 0.75 MEAN 6.32 11.9 40.3 63.8 18.8 29.4 504 .2 S.D. .210 .36 1.54 1.37 .51 .54 124.1 .15 N 6 6 6 6 6 6 6 6 12 9.4 6 98 Table 11 Summary of Clinical Hematology Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 9.4 4.0 4.3 .6 .4 .0 44 46 7 4 0 S.D. 1.89 1.31 1.59 .10 .27 .04 12.5 10.3 1.0 2.4 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 8.7 4.4 3.2 .8 .2 .0 48 39 9 2 0 S.D. 3.42 2.74 1.22 .41 .10 .10 13.2 11.2 3.9 1.0 1.0 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 8.7 4.4 3.4 .6 .2 .0 51 39 7 2 0 S.D. 1.25 .82 .69 .18 .12 .00 6.4 6.6 1.5 1.0 .4 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 8.1 4.6 2.9 .6 .1 .0 56 36 7 2 0 S.D. 1.91 1.75 1.02 .26 .08 .05 13.1 10.4 3.5 1.2 .5 N 6 6 6 6 6 6 6 6 6 6 6 99 Table 12 Summary of Clinical Hematology Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.68 12.5 40.9 61.4 18.7 30.6 464 .2 S.D. .421 .54 2.28 2.74 .88 .62 131.6 .26 N 6 6 6 6 6 6 6 6 17 18.7 6 0.03 MEAN 7.08 12.6 41.7 59.0 17.8 30.2 483 .2 S.D. .513 .46 1.91 2.70 .90 .82 167.0 .16 N 4 4 4 4 4 4 4 4 14 10.7 4 0.15 MEAN 6.78 12.6 41.3 61.1 18.7 30.6 519 .4 S.D. .479 .38 1.47 2.82 .95 .40 146.4 .15 N 6 6 6 6 6 6 6 6 30 9.6 6 0.75 MEAN 6.65 11.8 40.0 60.3 17.7 29.4 * 398 .6 S.D. .641 1.04 3.32 2.43 .87 .50 199.1 .48 N 6 6 6 6 6 6 6 6 39 30.3 6 100 Table 12 Summary of Clinical Hematology Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 7.3 2.7 3.9 .5 .2 .0 35 54 7 2 0 S.D. 2.62 1.64 .91 .29 .15 .08 8.6 8.3 2.9 2.7 .8 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 9.9 5.6 3.5 .6 .2 .0 56 36 6 2 0 S.D. 1.04 1.70 1.08 .22 .08 .00 15.0 13.5 1.8 1.0 .0 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 10.1 5.2 4.0 .7 .3 .0 49 42 7 2 0 S.D. 2.44 2.81 1.17 .12 .21 .05 18.2 16.4 2.5 2.0 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 9.0 4.3 3.6 .8 .2 .0 45 44 9 2 0 S.D. 2.87 3.02 1.08 .44 .18 .04 16.3 16.1 3.7 1.5 .4 N 6 6 6 6 6 6 6 6 6 6 6 101 Table 12 Summary of Clinical Hematology Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.60 12.4 40.6 61.7 18.8 30.6 520 .4 S.D. .559 .85 2.96 2.45 .77 .46 73.1 .31 N 6 6 6 6 6 6 6 6 24 20.5 6 0.03 MEAN 6.66 12.0 40.4 61.1 18.1 29.6 * 387 .6 S.D. .641 .92 2.44 6.52 2.23 .82 52.3 .61 N 4 4 4 4 4 4 4 4 39 33.6 4 0.15 MEAN 6.66 12.1 39.9 59.8 18.2 30.4 460 .3 S.D. .257 .45 1.31 2.12 .64 .18 83.7 .24 N 6 6 6 6 6 6 6 6 20 16.1 6 0.75 MEAN 6.33 11.7 39.5 62.4 18.5 29.7 * 492 .2 S.D. .288 .44 1.98 2.21 .70 .65 144.0 .12 N 6 6 6 6 6 6 6 6 11 7.9 6 102 Table 12 Summary of Clinical Hematology Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 9.7 4.6 4.1 .8 .2 .0 44 44 9 3 0 S.D. 2.44 2.98 1.08 .30 .18 .05 18.7 15.9 3.9 2.3 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 9.3 5.0 2.9 1.1 .2 .1 50 36 11 2 1 S.D. 4.49 3.55 .62 1.00 .14 .08 12.6 15.6 3.6 1.4 1.0 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 8.1 3.7 3.4 .6 .3 .0 44 44 8 3 0 S.D. 2.23 1.98 .96 .14 .15 .00 14.5 14.4 2.2 1.9 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 9.5 4.4 4.0 .8 .2 .0 46 43 9 2 1 S.D. 2.99 2.33 2.19 .35 .13 .05 17.4 16.5 4.3 .9 .5 N 6 6 6 6 6 6 6 6 6 6 6 103 Table 13 Summary of Clinical Hematology Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.60 12.5 41.1 62.3 18.9 30.3 467 .2 S.D. .354 .50 2.07 2.53 .78 .79 90.4 .08 N 6 6 6 6 6 6 6 6 11 5.8 6 0.03 MEAN 6.96 12.5 42.1 60.7 18.0 29.6 466 .2 S.D. .627 .45 1.79 2.81 1.05 .88 183.0 .17 N 4 4 4 4 4 4 4 4 12 11.8 4 0.15 MEAN 6.65 12.5 41.0 61.8 18.8 30.4 470 .3 S.D. .372 .31 1.15 2.76 .80 .30 63.1 .04 N 6 6 6 6 6 6 6 6 19 3.2 6 0.75 MEAN 6.32 11.4 * 38.8 61.5 17.9 29.2 * 401 .2 S.D. .387 .83 2.45 2.72 1.08 .48 228.0 .24 N 4 4 4 4 4 4 4 4 12 14.6 4 104 Table 13 Summary of Clinical Hematology Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 9.7 4.2 4.4 .7 .2 .0 45 46 7 2 0 S.D. 1.76 1.66 1.46 .46 .18 .05 16.1 12.4 4.1 2.0 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 8.4 4.8 2.8 .6 .2 .0 57 34 6 2 0 S.D. .74 1.46 .74 .26 .06 .00 15.1 10.6 3.8 1.0 .5 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 10.0 5.2 4.1 .5 .2 .0 50 42 5 2 0 S.D. 2.44 2.10 1.39 .14 .20 .00 15.2 13.6 2.4 2.1 .0 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 7.6 2.9 4.0 .5 .1 .0 38 53 7 2 0 S.D. 2.09 1.13 1.16 .12 .10 .06 6.9 9.1 2.9 1.7 .6 N 4 4 4 4 4 4 4 4 4 4 4 105 Table 13 Summary of Clinical Hematology Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.40 12.1 40.8 63.8 19.0 29.7 484 .4 S.D. .461 .64 2.67 2.49 .70 .65 100.1 .24 N 6 6 6 6 6 6 6 6 27 15.1 6 0.03 MEAN 6.15 11.2 38.3 62.3 18.2 29.3 429 .2 S.D. .798 1.66 5.67 6.23 2.09 .94 54.7 .13 N 4 4 4 4 4 4 4 4 13 5.8 4 0.15 MEAN 6.57 11.9 39.9 60.8 18.2 29.9 412 .2 S.D. .256 .62 1.78 2.50 .73 .35 74.4 .12 N 6 6 6 6 6 6 6 6 12 7.5 6 0.75 MEAN 6.09 11.3 39.2 64.3 18.6 29.0 490 .2 S.D. .360 .37 2.17 1.46 .71 1.09 166.0 .21 N 6 6 6 6 6 6 6 6 12 12.7 6 106 Table 13 Summary of Clinical Hematology Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 10.4 5.0 4.3 .7 .2 .0 46 44 8 3 0 S.D. 3.59 3.41 1.96 .15 .19 .05 17.5 15.1 3.4 1.8 .5 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 8.5 4.3 3.2 .7 .3 .0 50 38 8 3 0 S.D. 2.05 1.45 .57 .32 .15 .10 9.3 10.1 2.2 1.4 1.0 N 4 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 9.2 4.5 3.8 .6 .3 .0 48 43 6 3 0 S.D. 1.61 1.73 .61 .18 .24 .04 13.0 11.7 2.1 2.0 .8 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 9.7 4.2 4.6 .7 .2 .1 46 45 8 2 0 S.D. 2.73 1.10 2.70 .32 .08 .05 14.6 14.8 3.4 .8 .5 N 6 6 6 6 6 6 6 6 6 6 6 107 Table 14 Summary of Clinical Hematology Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.26 12.0 38.1 60.8 19.1 31.5 483 .4 S.D. .007 .21 .28 .35 .28 .35 193.7 .07 N 2 2 2 2 2 2 2 2 22 4.2 2 0.15 MEAN 6.49 12.7 40.7 62.8 19.6 31.2 488 .3 S.D. .057 .42 1.27 1.34 .42 .07 118.8 .14 N 2 2 2 2 2 2 2 2 20 9.2 2 0.75 MEAN 5.90 11.6 37.8 64.0 19.5 30.6 469 .4 S.D. .042 .07 .64 .71 .07 .42 22.6 .21 N 2 2 2 2 2 2 2 2 26 12.0 2 108 Table 14 Summary of Clinical Hematology Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN X103/mcL BASO N-SEG% X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 7.3 2.4 4.0 .6 .2 .0 34 54 9 3 1 S.D. 1.70 .14 1.63 .14 .07 .00 4.9 9.9 4.2 .0 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 11.5 6.2 4.5 .6 .3 .0 53 38 6 3 0 S.D. 3.82 2.05 2.12 .21 .14 .00 .0 5.7 3.5 2.8 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 11.8 6.0 4.4 .9 .4 .0 50 39 7 4 0 S.D. 4.10 2.69 .78 .57 .07 .00 5.7 7.1 2.8 .0 .0 N 2 2 2 2 2 2 2 2 2 2 2 109 Table 14 Summary of Clinical Hematology Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 5.94 11.8 36.9 62.0 19.8 32.0 468 .3 S.D. .714 1.20 4.81 .64 .35 .99 111.0 .28 N 2 2 2 2 2 2 2 2 18 19.1 2 0.15 MEAN 6.14 11.9 37.6 61.4 19.5 31.7 408 .4 S.D. .092 .14 .57 .07 .07 .14 37.5 .21 N 2 2 2 2 2 2 2 2 22 13.4 2 0.75 MEAN 6.42 12.0 40.2 62.6 18.7 29.8 444 .5 S.D. .417 .28 2.90 .57 .71 1.34 160.5 .28 N 2 2 2 2 2 2 2 2 32 20.5 2 110 Table 14 Summary of Clinical Hematology Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN X103/mcL BASO N-SEG% X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 8.2 4.6 2.8 .6 .1 .0 55 36 8 2 0 S.D. 2.76 2.12 .35 .28 .00 .00 7.1 7.8 .7 .7 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 7.6 2.6 4.0 .6 .4 .0 34 53 8 4 1 S.D. 1.06 1.20 .35 .14 .21 .07 10.6 11.3 2.8 2.1 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 9.3 2.6 5.8 .6 .2 .0 28 64 6 3 0 S.D. 2.26 .64 1.20 .35 .07 .07 .7 2.1 2.8 1.4 .7 N 2 2 2 2 2 2 2 2 2 2 2 111 Table 15 Summary of Clinical Hematology Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.52 12.6 39.2 60.2 19.4 32.1 556 .2 S.D. .332 .57 1.91 .07 .07 .00 181.7 .14 N 2 2 2 2 2 2 2 2 13 8.5 2 0.15 MEAN 6.78 13.3 42.2 62.1 19.6 31.6 493 .2 S.D. .049 .00 .49 1.13 .28 .21 36.8 .07 N 2 2 2 2 2 2 2 2 10 4.9 2 0.75 MEAN 6.20 11.9 39.5 63.7 19.2 30.1 532 .6 S.D. .191 .71 .64 .99 .49 1.27 43.1 .28 N 2 2 2 2 2 2 2 2 36 16.3 2 112 Table 15 Summary of Clinical Hematology Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN X103/mcL BASO N-SEG% X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 10.0 3.2 6.1 .4 .3 .0 32 60 4 3 0 S.D. 2.90 .78 2.12 .07 .00 .00 1.4 3.5 .7 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 11.4 5.5 4.8 .6 .4 .0 48 42 6 3 0 S.D. 1.13 .42 1.06 .28 .07 .00 .7 4.9 3.5 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 13.4 5.6 6.2 1.0 .5 .1 41 47 8 4 1 S.D. 5.52 2.83 1.77 .64 .14 .00 4.2 5.7 2.1 .0 .0 N 2 2 2 2 2 2 2 2 2 2 2 113 Table 15 Summary of Clinical Hematology Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.22 12.3 38.4 61.6 19.8 32.1 519 .2 S.D. .735 1.41 4.95 .71 .07 .49 82.0 .07 N 2 2 2 2 2 2 2 2 16 6.4 2 0.15 MEAN 6.74 12.7 40.7 60.3 18.8 31.2 425 .2 S.D. .191 .28 .35 1.27 .14 .28 48.1 .07 N 2 2 2 2 2 2 2 2 10 4.2 2 0.75 MEAN 6.70 12.5 42.0 62.7 18.7 29.8 440 .2 S.D. .453 .42 2.97 .21 .71 1.20 149.2 .21 N 2 2 2 2 2 2 2 2 17 15.6 2 114 Table 15 Summary of Clinical Hematology Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN X103/mcL BASO N-SEG% X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 11.4 7.1 3.4 .7 .2 .0 62 30 6 2 0 S.D. 1.56 2.83 .85 .28 .14 .00 16.3 12.0 2.8 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 9.4 3.0 5.0 1.0 .4 .0 28 56 11 4 0 S.D. 2.76 2.97 .49 .00 .28 .07 23.3 21.9 2.8 1.4 .7 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 11.0 3.6 6.2 .9 .2 .1 32 56 8 2 1 S.D. .21 1.34 1.77 .28 .07 .00 12.7 14.8 2.8 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 115 Table 16 Summary of Clinical Hematology Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.72 12.6 40.1 59.6 18.8 31.6 504 .2 S.D. .198 .49 2.12 1.34 .21 .42 228.4 .07 N 2 2 2 2 2 2 2 2 17 4.2 2 0.15 MEAN 6.78 13.1 41.8 61.5 19.3 31.4 496 .4 S.D. .106 .42 2.05 1.98 .28 .49 105.4 .28 N 2 2 2 2 2 2 2 2 27 19.8 2 0.75 MEAN 6.45 12.3 41.0 63.6 19.1 29.9 519 .3 S.D. .495 1.13 2.40 1.13 .21 .92 60.8 .14 N 2 2 2 2 2 2 2 2 19 7.1 2 116 Table 16 Summary of Clinical Hematology Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN X103/mcL BASO N-SEG% X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 7.3 2.6 3.7 .8 .1 .0 36 51 10 2 1 S.D. .42 .28 .42 .35 .00 .07 6.4 2.8 4.2 .0 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 11.5 6.6 4.1 .4 .2 .0 58 36 4 2 0 S.D. 2.26 2.05 .14 .21 .14 .00 6.4 8.5 1.4 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 11.6 5.0 5.4 .8 .4 .0 40 49 7 2 1 S.D. 6.22 3.54 1.91 .49 .21 .07 9.2 9.9 .0 .7 .0 N 2 2 2 2 2 2 2 2 2 2 2 117 Table 16 Summary of Clinical Hematology Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.32 12.3 39.0 61.7 19.5 31.6 510 .4 S.D. 1.082 1.70 7.57 1.41 .71 1.91 135.8 .00 N 2 2 2 2 2 2 2 2 25 4.2 2 0.15 MEAN 6.64 12.6 40.1 60.3 18.8 31.2 423 .4 S.D. .071 .07 .57 .21 .35 .64 5.7 .21 N 2 2 2 2 2 2 2 2 23 14.1 2 0.75 MEAN 6.78 12.5 40.8 60.2 18.4 30.5 440 .4 S.D. .410 .35 1.56 1.34 .64 .35 137.9 .35 N 2 2 2 2 2 2 2 2 30 21.9 2 118 Table 16 Summary of Clinical Hematology Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN X103/mcL BASO N-SEG% X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 8.8 5.4 2.8 .5 .0 .0 60 33 6 1 0 S.D. 1.13 2.40 .99 .14 .07 .00 19.1 15.6 2.8 1.4 .7 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 7.8 2.9 3.8 .6 .4 .0 34 53 8 5 1 S.D. 2.26 2.55 .64 .07 .28 .07 22.6 22.6 .7 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 9.2 4.4 4.1 .6 .1 .0 48 44 6 0 0 S.D. 2.26 .92 .85 .49 .00 .07 2.1 2.1 3.5 .7 .7 N 2 2 2 2 2 2 2 2 2 2 2 119 Table 17 Summary of Clinical Hematology Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.72 12.6 40.2 59.8 18.8 31.5 544 .3 S.D. .078 .35 .57 .07 .28 .42 209.3 .28 N 2 2 2 2 2 2 2 2 20 19.1 2 0.15 MEAN 6.80 13.2 41.9 61.5 19.4 31.5 491 .2 S.D. .127 .57 1.84 1.48 .49 .07 80.6 .07 N 2 2 2 2 2 2 2 2 10 4.9 2 0.75 MEAN 6.22 11.8 38.1 61.1 19.0 31.0 572 .6 S.D. .198 .42 .35 1.34 .07 .71 43.1 .35 N 2 2 2 2 2 2 2 2 34 21.2 2 120 Table 17 Summary of Clinical Hematology Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN X103/mcL BASO N-SEG% X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 8.6 4.2 3.8 .6 .1 .0 48 42 8 1 0 S.D. 1.20 .21 1.06 .07 .00 .00 4.9 6.4 1.4 .0 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 12.8 8.2 3.7 .8 .2 .0 64 30 6 1 0 S.D. 1.34 2.05 .99 .21 .07 .00 9.2 10.6 1.4 .0 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 9.0 4.0 3.9 .8 .2 .0 43 44 10 2 0 S.D. 3.75 2.55 1.13 .07 .07 .07 9.9 6.4 2.8 1.4 .7 N 2 2 2 2 2 2 2 2 2 2 2 121 Table 17 Summary of Clinical Hematology Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.32 12.3 38.4 60.8 19.6 32.1 546 .2 S.D. .403 .64 2.12 .49 .21 .07 140.0 .14 N 2 2 2 2 2 2 2 2 13 9.9 2 0.15 MEAN 6.76 12.5 40.1 59.4 18.4 31.0 472 .4 S.D. .071 .00 .78 1.77 .21 .64 103.9 .07 N 2 2 2 2 2 2 2 2 24 4.9 2 0.75 MEAN 6.50 11.9 39.5 60.8 18.4 30.2 424 .3 S.D. .431 .42 2.19 .64 .64 .71 155.6 .28 N 2 2 2 2 2 2 2 2 20 19.8 2 122 Table 17 Summary of Clinical Hematology Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 11.8 7.2 3.2 1.0 .2 .0 59 30 8 2 0 S.D. 4.38 3.96 .07 .57 .07 .00 11.3 11.3 2.1 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 9.4 4.2 4.2 .6 .4 .0 42 48 7 4 0 S.D. 2.83 3.18 .42 .21 .28 .00 21.2 19.1 4.2 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 8.9 2.7 5.6 .6 .2 .0 30 62 6 2 0 S.D. 1.56 .57 .78 .07 .07 .00 1.4 1.4 .7 .7 .0 N 2 2 2 2 2 2 2 2 2 2 2 123 Table 18 Summary of Clinical Hematology Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.53 12.4 39.5 60.5 19.2 31.6 514 .1 6 S.D. .042 .07 .07 .49 .21 .07 179.6 .14 9.2 N 2 2 2 2 2 2 2 2 2 0.15 MEAN 6.72 13.0 41.2 61.3 19.4 31.7 448 .1 7 S.D. .283 .64 2.97 1.91 .28 .57 68.6 .14 9.9 N 2 2 2 2 2 2 2 2 2 0.75 MEAN S.D. N 6.23 .198 2 12.2 .21 2 38.9 .28 2 62.5 2.40 2 19.5 .28 2 31.2 .85 2 508 17.7 2 .8 1.06 2 46 64.3 2 124 Table 18 Summary of Clinical Hematology Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 10.8 6.6 3.4 .7 .0 .0 61 32 6 0 0 S.D. .14 .99 .92 .14 .07 .07 8.5 9.2 .7 .7 .7 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 12.5 8.2 3.5 .8 .1 .0 64 28 6 0 0 S.D. 1.84 1.98 .71 .49 .14 .00 6.4 10.6 2.8 .7 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 12.2 6.4 4.2 1.1 .4 .0 52 36 9 3 0 S.D. 3.96 2.69 .78 .42 .07 .07 4.9 5.7 .0 .0 .7 N 2 2 2 2 2 2 2 2 2 2 2 125 Table 18 Summary of Clinical Hematology Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.28 12.4 38.1 60.8 19.8 32.6 534 .2 S.D. .453 .78 2.90 .35 .14 .42 142.8 .07 N 2 2 2 2 2 2 2 2 10 4.9 2 0.15 MEAN 6.77 12.6 40.8 60.2 18.6 31.0 456 .2 S.D. .113 .14 1.34 .92 .07 .64 67.9 .07 N 2 2 2 2 2 2 2 2 10 4.2 2 0.75 MEAN 6.54 12.2 40.1 61.3 18.6 30.4 448 .2 S.D. .028 .07 .57 1.13 .14 .78 181.7 .07 N 2 2 2 2 2 2 2 2 10 4.2 2 126 Table 18 Summary of Clinical Hematology Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 7.4 3.4 2.8 1.0 .2 .0 46 37 14 3 0 S.D. 1.48 1.13 .42 .28 .14 .00 6.4 1.4 6.4 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 8.1 3.0 3.7 .9 .4 .0 38 46 11 5 0 S.D. .57 .71 .99 .42 .14 .07 10.6 9.2 4.2 2.8 .7 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 10.8 4.7 5.2 .8 .1 .0 43 48 8 1 0 S.D. .78 .57 .21 .42 .14 .00 1.4 4.9 3.5 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 127 Table 19 Summary of Clinical Hematology Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.63 12.9 40.2 60.7 19.4 32.0 460 .3 S.D. .269 .57 1.34 .42 .00 .28 174.7 .14 N 2 2 2 2 2 2 2 2 20 9.9 2 0.15 MEAN 7.16 14.0 45.6 63.7 19.5 30.6 490 .3 S.D. .049 .21 .99 .92 .14 .21 106.8 .28 N 2 2 2 2 2 2 2 2 22 20.5 2 0.75 MEAN 6.30 12.6 40.6 64.5 19.9 31.0 510 .7 S.D. .530 .92 2.69 1.13 .21 .14 92.6 .99 N 2 2 2 2 2 2 2 2 42 58.7 2 128 Table 19 Summary of Clinical Hematology Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 11.6 6.4 4.4 .6 .1 .0 55 38 6 1 0 S.D. .57 1.48 .78 .07 .00 .07 9.9 8.5 .7 .0 .7 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 11.6 4.9 5.9 .6 .2 .0 42 50 6 2 0 S.D. 1.27 1.13 .42 .21 .00 .00 4.9 2.1 2.1 .7 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 16.6 10.3 4.8 1.2 .4 .1 62 28 6 2 0 S.D. 6.51 3.96 1.77 .64 .21 .00 .7 .7 .7 1.4 .7 N 2 2 2 2 2 2 2 2 2 2 2 129 Table 19 Summary of Clinical Hematology Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.26 12.4 38.5 61.6 19.8 32.2 494 .5 S.D. .884 1.56 5.23 .35 .35 .49 122.3 .14 N 2 2 2 2 2 2 2 2 31 4.2 2 0.15 MEAN 6.66 12.7 40.8 61.4 19.2 31.2 451 .3 S.D. .064 .00 .85 .71 .21 .78 14.1 .14 N 2 2 2 2 2 2 2 2 20 9.2 2 0.75 MEAN 7.06 13.1 42.9 60.8 18.5 30.6 446 .2 S.D. .629 .57 3.18 .92 .78 .92 215.7 .21 N 2 2 2 2 2 2 2 2 12 16.3 2 130 Table 19 Summary of Clinical Hematology Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 8.8 4.4 3.4 .7 .3 .0 50 38 8 3 0 S.D. .78 .14 .64 .14 .14 .00 6.4 3.5 .7 1.4 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 9.9 3.8 4.6 .9 .6 .0 37 48 9 6 0 S.D. 1.70 1.70 .07 .14 .28 .00 11.3 6.4 .0 4.2 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 10.6 3.0 6.2 1.0 .3 .2 29 58 9 3 2 S.D. .92 .71 1.56 .07 .14 .07 9.9 9.9 1.4 1.4 .7 N 2 2 2 2 2 2 2 2 2 2 2 131 Table 20 Summary of Clinical Hematology Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.56 12.6 40.7 61.9 19.2 31.0 434 .5 S.D. .035 .00 1.06 1.27 .07 .71 96.9 .28 N 2 2 2 2 2 2 2 2 33 18.4 2 0.15 MEAN 6.90 13.6 43.9 63.6 19.8 31.1 373 .7 S.D. .141 .21 .42 .71 .00 .28 5.7 .00 N 2 2 2 2 2 2 2 2 48 .7 2 0.75 MEAN 6.42 12.6 42.4 66.0 19.6 29.8 520 .6 S.D. .000 .14 1.56 2.33 .14 .78 59.4 .42 N 2 2 2 2 2 2 2 2 38 27.6 2 132 Table 20 Summary of Clinical Hematology Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 8.4 3.1 4.2 .8 .1 .2 36 52 9 1 2 S.D. 1.77 1.56 .14 .42 .00 .21 11.3 12.0 2.8 .0 2.1 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 10.9 5.0 4.7 .8 .4 .1 46 42 8 2 1 S.D. 3.96 1.70 2.12 .14 .21 .00 1.4 4.2 4.2 .7 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 16.0 9.8 4.4 1.2 .2 .2 62 28 8 2 2 S.D. .35 1.48 1.41 .07 .21 .14 11.3 7.8 .7 .7 .7 N 2 2 2 2 2 2 2 2 2 2 2 133 Table 20 Summary of Clinical Hematology Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE RBC HGB HCT mg/kg/day X106/mcL G/DL % MCV FL MCH PG MCHC % PLT X103/mcL RETIC % RETIC X103/mcL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.02 11.8 37.5 62.5 19.8 31.6 508 .4 S.D. .700 1.06 4.17 .21 .49 .71 35.4 .21 N 2 2 2 2 2 2 2 2 26 9.2 2 0.15 MEAN 6.46 12.3 40.2 62.2 19.0 30.6 406 .4 S.D. .191 .42 1.34 .21 .14 .14 2.1 .21 N 2 2 2 2 2 2 2 2 29 12.7 2 0.75 MEAN 6.72 12.4 40.8 60.8 18.5 30.4 396 .3 S.D. .134 .14 .28 1.56 .57 .14 146.4 .14 N 2 2 2 2 2 2 2 2 20 9.9 2 134 Table 20 Summary of Clinical Hematology Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day WBC N-SEG X103/mcL X103/mcL LYMPH MONO X103/mcL X103/mcL EOSIN BASO N-SEG% X103/mcL X103/mcL LYMPH% MONO% EOSIN% BASO% ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 11.2 7.0 2.8 1.0 .3 .2 58 28 10 2 1 S.D. 6.15 4.95 .49 .42 .14 .07 12.0 11.3 .7 .7 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 11.5 5.4 4.2 1.0 .6 .2 46 37 10 5 2 S.D. 3.25 2.33 1.20 .07 .21 .00 7.1 .0 2.8 2.8 .0 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 10.4 3.1 6.4 .5 .2 .2 30 61 5 2 2 S.D. .85 .14 .92 .00 .14 .07 3.5 4.2 .0 .7 .7 N 2 2 2 2 2 2 2 2 2 2 2 135 Table 21 Summary of Clinical Chemistry Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 76 20 1.2 9.0 4.9 4.1 .6 S.D. 12.5 3.8 .10 .32 .21 .26 .45 N 6 6 6 6 6 6 6 9 138 2.0 33.7 6 6 70 13.3 6 0.03 MEAN 70 20 1.2 9.6 5.2 4.4 .4 S.D. 8.3 6.2 .17 .58 .46 .48 .18 N 4 4 4 4 4 4 4 9 110 1.4 20.1 4 4 61 35.0 4 0.15 MEAN 82 21 1.2 9.5 5.1 4.4 .6 10 151 56 S.D. 30.4 3.3 .22 .44 .34 .26 .37 2.2 26.1 4.9 N 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 73 20 1.3 9.4 5.2 4.3 .5 S.D. 15.4 2.0 .11 .38 .28 .37 .29 N 6 6 6 6 6 6 6 9 138 1.3 29.3 6 6 67 11.0 6 136 Table 21 Summary of Clinical Chemistry Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 56 16.5 6 32 9.7 6 711 252.6 6 134 42.8 6 7 1133 1.9 535.3 6 6 395 93.4 6 55 84.4 6 247 54.0 6 0.03 MEAN S.D. N 44 6.3 4 36 11.2 4 700 265.6 4 141 34.5 4 3 936 476 1.0 709.0 164.6 4 4 4 35 20.6 4 302 107.4 4 0.15 MEAN S.D. N 72 23.5 6 69 35.7 6 770 210.3 6 160 68.4 6 8 1087 5.4 322.3 6 6 386 94.5 6 51 42.4 6 242 62.4 6 0.75 MEAN S.D. N 68 11.7 6 80 54.2 6 840 360.9 6 171 53.3 6 6 1094 1.5 497.4 6 6 529 135.6 6 41 31.8 6 324 72.2 6 137 Table 21 Summary of Clinical Chemistry Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.8 S.D. .60 N 6 6.2 .84 6 159 4.6 6 5.4 .58 6 109 2.9 6 0.03 MEAN S.D. N 11.6 .53 4 6.6 .44 4 164 6.0 4 5.9 .32 4 111 2.2 4 0.15 MEAN S.D. N 11.5 .62 6 7.1 .99 6 163 5.3 6 6.4 .60 6 112 2.7 6 0.75 MEAN S.D. N 11.3 .54 6 6.9 1.06 6 161 4.8 6 5.8 .62 6 108 2.9 6 Covance 6329-223 3M T-6295.7 138 Table 21 Summary of Clinical Chemistry Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 76 22 1.2 9.6 4.9 4.7 .5 S.D. 22.2 1.6 .08 .78 .35 .83 .34 N 6 6 6 6 6 6 6 7 149 1.9 37.2 6 6 73 32.4 6 0.03 MEAN 73 22 1.2 9.3 4.7 4.6 .5 S.D. 10.7 1.3 .08 .50 .18 .41 .17 N 4 4 4 4 4 4 4 6 130 1.7 12.4 4 4 62 7.5 4 0.15 MEAN 76 23 1.1 9.6 4.7 4.9 .6 12 144 58 S.D. 12.0 3.9 .10 .62 .57 .38 .21 12.1 14.0 11.7 N 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 78 24 1.2 9.4 4.8 4.6 .6 S.D. 16.3 3.9 .18 .78 .40 .65 .37 N 6 6 6 6 6 6 6 9 154 1.4 10.1 6 6 61 16.6 6 139 Table 21 Summary of Clinical Chemistry Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 64 6.7 6 140 76.9 6 291 130.1 6 123 54.0 6 4 979 374 1.6 384.3 121.9 6 6 6 28 12.5 6 220 73.1 6 0.03 MEAN S.D. N 54 10.2 4 103 29.4 4 201 12.5 4 94 48.5 4 3 484 378 .8 156.7 153.7 4 4 4 26 15.9 4 237 79.9 4 0.15 MEAN S.D. N 74 35.5 6 110 41.0 6 257 118.5 6 87 32.9 6 4 844 416 2.4 306.4 121.0 6 6 6 35 21.2 6 244 81.3 6 0.75 MEAN S.D. N 72 15.4 6 123 54.2 6 310 141.4 6 75 24.3 6 4 1624 2.0 1251.5 6 6 384 88.6 6 19 15.4 6 247 54.1 6 140 Table 21 Summary of Clinical Chemistry Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 11.4 S.D. 1.10 N 6 6.2 .63 6 163 7.1 6 6.2 .96 6 114 5.0 6 0.03 MEAN S.D. N 10.9 .58 4 4.7 .99 4 163 3.4 4 5.9 .70 4 115 3.3 4 0.15 MEAN S.D. N 11.0 .59 6 5.9 .78 6 162 6.1 6 6.1 .63 6 115 3.1 6 0.75 MEAN S.D. N 11.3 .59 6 5.5 .50 6 163 4.9 6 6.1 .80 6 114 1.5 6 Covance 6329-223 3M T-6295.7 141 Table 22 Summary of Clinical Chemistry Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 60 20 1.1 8.9 4.7 4.2 .8 S.D. 5.9 3.3 .12 .56 .13 .49 .43 N 6 6 6 6 6 6 6 9 140 1.5 22.1 6 6 69 18.7 6 0.03 MEAN 62 18 1.2 9.3 5.0 4.3 .4 S.D. 8.3 3.9 .18 1.02 .46 .85 .16 N 4 4 4 4 4 4 4 8 118 1.3 28.4 4 4 47 4.6 4 0.15 MEAN 61 21 1.2 9.2 4.8 4.4 .6 S.D. 9.8 4.9 .23 .33 .25 .32 .27 N 6 6 6 6 6 6 6 8 146 .8 21.5 6 6 58 5.3 6 0.75 MEAN 65 21 1.3 9.3 5.1 4.2 .4 S.D. 7.8 2.3 .12 .37 .36 .40 .17 N 6 6 6 6 6 6 6 7 130 1.5 18.0 6 6 91 27.3 6 142 Table 22 Summary of Clinical Chemistry Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 45 15.9 6 39 19.5 6 888 339.5 6 134 42.9 6 7 354 374 2.6 461.0 106.3 6 6 6 22 12.5 6 222 58.4 6 0.03 MEAN S.D. N 37 6.3 4 40 13.0 4 876 384.3 4 120 35.4 4 3 191 459 1.5 58.2 149.3 4 4 4 24 13.6 4 282 93.3 4 0.15 MEAN S.D. N 48 15.9 6 50 23.8 6 896 267.3 6 136 57.3 6 5 184 369 3.2 59.7 78.9 6 6 6 40 21.7 6 221 55.5 6 0.75 MEAN S.D. N 43 10.0 6 46 23.0 6 996 417.0 6 142 39.9 6 2* 283 522 .4 149.7 124.7 6 6 6 26 10.9 6 307 55.9 6 143 Table 22 Summary of Clinical Chemistry Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.6 S.D. .25 N 6 6.7 .80 6 160 3.6 6 5.4 .28 6 115 3.4 6 0.03 MEAN S.D. N 11.2 1.12 4 6.9 1.58 4 165 10.1 4 5.8 .74 4 116 4.2 4 0.15 MEAN S.D. N 11.0 .39 6 6.8 1.00 6 160 3.1 6 5.6 .38 6 115 .9 6 0.75 MEAN S.D. N 10.9 .43 6 6.6 1.29 6 162 3.4 6 5.4 .29 6 114 2.7 6 Covance 6329-223 3M T-6295.7 144 Table 22 Summary of Clinical Chemistry Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 58 22 1.1 9.3 4.4 4.9 .6 S.D. 14.7 4.4 .16 .71 .26 .80 .34 N 6 6 6 6 6 6 6 8 147 .5 26.9 6 6 71 25.7 6 0.03 MEAN 67 21 1.1 9.0 4.5 4.5 .5 S.D. 15.2 3.0 .05 .41 .15 .39 .25 N 4 4 4 4 4 4 4 9 124 2.5 11.1 4 4 64 12.0 4 0.15 MEAN 60 20 1.0 9.2 4.3 4.9 .6 S.D. 8.4 3.6 .04 .26 .37 .40 .14 N 6 6 6 6 6 6 6 8 133 3.2 22.4 6 6 57 11.3 6 0.75 MEAN 70 22 1.1 9.1 4.4 4.7 .4 S.D. 11.5 5.4 .14 .31 .10 .38 .15 N 6 6 6 6 6 6 6 7 123 1.2 14.1 6 6 66 23.0 6 145 Table 22 Summary of Clinical Chemistry Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 44 12.1 6 59 30.2 6 362 125.6 6 102 42.9 6 5 240 339 2.4 146.6 89.9 6 6 6 18 13.2 6 194 58.2 6 0.03 MEAN S.D. N 49 15.9 4 70 13.3 4 240 48.7 4 88 54.7 4 3 378 384 1.3 262.2 110.9 4 4 4 28 15.2 4 237 55.5 4 0.15 MEAN S.D. N 36 6.6 6 68 30.9 6 319 129.0 6 76 20.3 6 3 198 414 1.5 101.3 115.1 6 6 6 34 17.4 6 230 70.7 6 0.75 MEAN S.D. N 36 8.0 6 46 7.5 6 415 188.9 6 58 20.0 6 2* 331 373 .9 242.1 83.3 6 6 6 23 5.9 6 230 66.0 6 146 Table 22 Summary of Clinical Chemistry Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.4 S.D. .39 N 6 5.7 .73 6 161 4.9 6 5.7 .38 6 115 4.4 6 0.03 MEAN S.D. N 10.2 .42 4 4.2 * .37 4 161 5.4 4 5.2 .92 4 116 4.3 4 0.15 MEAN S.D. N 9.7 .73 6 5.1 .65 6 157 2.5 6 5.2 .39 6 114 1.1 6 0.75 MEAN S.D. N 10.4 .25 6 5.0 .48 6 160 5.3 6 5.9 .42 6 116 3.0 6 Covance 6329-223 3M T-6295.7 147 Table 23 Summary of Clinical Chemistry Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 59 20 1.1 8.6 4.6 4.0 .7 S.D. 9.1 3.9 .08 .50 .17 .42 .42 N 6 6 6 6 6 6 6 9 153 1.5 23.0 6 6 62 19.0 6 0.03 MEAN 59 20 1.2 9.0 4.7 4.3 .4 10 114 * 60 S.D. 2.9 3.7 .14 .69 .36 .58 .10 2.2 25.1 14.8 N 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 67 18 1.2 8.8 4.6 4.1 .5 10 144 57 S.D. 13.3 3.9 .19 .42 .48 .44 .23 1.7 19.7 13.4 N 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 74 19 1.3 8.8 4.8 4.0 .3 10 125 76 S.D. 10.6 2.6 .12 .41 .53 .59 .06 2.7 20.6 16.6 N 6 6 6 6 6 6 6 6 6 6 148 Table 23 Summary of Clinical Chemistry Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 36 7.9 6 34 15.2 6 839 321.9 6 130 46.2 6 7 132 371 2.3 27.8 115.8 6 6 6 22 13.9 6 224 64.2 6 0.03 MEAN S.D. N 35 7.2 4 35 17.5 4 750 369.9 4 116 25.0 4 4 149 428 1.5 47.7 143.3 4 4 4 21 13.8 4 270 92.9 4 0.15 MEAN S.D. N 40 9.4 6 37 11.7 6 806 237.8 6 128 39.4 6 5 153 344 3.8 19.9 89.3 6 6 6 20 11.3 6 213 61.7 6 0.75 MEAN S.D. N 34 6.3 6 43 16.2 6 823 367.0 6 125 29.9 6 3 203 * 499 .8 57.2 119.4 6 6 6 22 13.4 6 301 53.4 6 149 Table 23 Summary of Clinical Chemistry Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.4 S.D. .39 N 6 7.1 .66 6 160 2.9 6 5.4 .44 6 120 2.5 6 0.03 MEAN S.D. N 10.5 .44 4 6.8 .88 4 166 12.5 4 5.6 .92 4 122 9.3 4 0.15 MEAN S.D. N 10.4 .26 6 6.6 1.08 6 160 3.5 6 5.4 .50 6 120 3.5 6 0.75 MEAN S.D. N 10.5 .60 6 6.8 1.31 6 159 6.4 6 5.6 .63 6 120 2.8 6 Covance 6329-223 3M T-6295.7 150 Table 23 Summary of Clinical Chemistry Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 57 21 1.1 9.0 4.4 4.7 .5 S.D. 10.2 3.5 .13 .57 .21 .75 .24 N 6 6 6 6 6 6 6 9 155 .8 45.4 6 6 86 49.4 6 0.03 MEAN 66 22 1.1 8.8 4.3 4.5 .6 10 127 76 S.D. 17.3 3.4 .05 .44 .10 .46 .26 3.7 11.2 21.5 N 4 4 4 4 4 4 4 4 4 4 0.15 MEAN 62 20 1.0 9.0 4.3 4.7 .6 10 137 64 S.D. 12.6 2.7 .10 .15 .33 .24 .18 3.2 19.5 18.0 N 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 74 20 1.2 9.0 4.4 4.6 .4 S.D. 7.2 5.0 .13 .44 .17 .39 .10 N 6 6 6 6 6 6 6 9 127 1.9 18.9 6 6 61 10.5 6 151 Table 23 Summary of Clinical Chemistry Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 38 3.4 6 53 16.7 6 360 152.5 6 106 47.7 6 4 262 342 1.8 123.6 86.9 6 6 6 14 14.7 6 198 55.5 6 0.03 MEAN S.D. N 45 9.9 4 77 15.8 4 241 45.3 4 84 44.5 4 4 276 358 2.2 67.9 108.3 4 4 4 19 16.7 4 228 55.8 4 0.15 MEAN S.D. N 37 7.8 6 60 29.3 6 305 134.0 6 75 20.8 6 4 194 410 1.0 76.1 129.7 6 6 6 28 19.6 6 234 82.3 6 0.75 MEAN S.D. N 31 7.8 6 42 6.2 6 398 200.5 6 58 20.0 6 2* 243 385 .4 130.1 89.4 6 6 6 27 9.9 6 246 56.7 6 152 Table 23 Summary of Clinical Chemistry Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.0 S.D. .34 N 6 6.0 .36 6 162 6.5 6 5.8 .59 6 120 5.1 6 0.03 MEAN S.D. N 9.9 .22 4 4.6 * .30 4 160 2.9 4 5.2 .43 4 120 2.2 4 0.15 MEAN S.D. N 9.6 .48 6 5.1 * .51 6 160 3.6 6 5.5 .60 6 123 3.0 6 0.75 MEAN S.D. N 10.2 .60 6 5.0 * .30 6 161 3.5 6 5.8 .67 6 120 1.8 6 Covance 6329-223 3M T-6295.7 153 Table 24 Summary of Clinical Chemistry Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 60 20 1.1 8.7 4.8 3.9 .7 S.D. 8.0 4.3 .14 .40 .12 .33 .38 N 6 6 6 6 6 6 6 8 154 1.2 24.6 6 6 68 20.4 6 0.03 MEAN 64 20 1.3 9.6 5.3 * 4.2 .4 S.D. 7.6 4.9 .22 .98 .39 .75 .13 N 4 4 4 4 4 4 4 8 126 .6 14.9 4 4 54 9.8 4 0.15 MEAN 75 19 1.2 9.0 5.0 4.0 .4 S.D. 18.5 4.6 .16 .19 .14 .21 .22 N 6 6 6 6 6 6 6 9 150 2.7 18.8 6 6 50 10.4 6 0.75 MEAN S.D. N 73 19.1 6 19 1.3 6 1.4 .19 6 9.4 .36 6 5.2 * .31 6 4.2 .35 6 .3 * .05 6 10 3.6 6 112 * 27.0 6 73 21.0 6 154 Table 24 Summary of Clinical Chemistry Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 39 7.7 6 35 15.8 6 866 296.2 6 136 50.1 6 7 168 392 2.6 32.4 111.8 6 6 6 33 30.3 6 265 71.2 6 0.03 MEAN S.D. N 35 7.0 4 60 55.8 4 789 401.7 4 131 34.5 4 4 175 465 1.4 42.5 185.6 4 4 4 48 57.9 4 318 125.4 4 0.15 MEAN S.D. N 42 12.2 6 45 22.4 6 851 265.3 6 140 58.6 6 6 164 377 4.3 36.2 94.9 6 6 6 27 18.3 6 258 70.1 6 0.75 MEAN S.D. N 36 6.3 6 44 21.0 6 807 428.6 6 127 27.4 6 2* 214 468 .6 75.7 149.1 6 6 6 32 17.5 6 350 70.4 6 155 Table 24 Summary of Clinical Chemistry Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.3 S.D. .77 N 6 6.8 .37 6 160 7.1 6 5.1 .56 6 117 5.3 6 0.03 MEAN S.D. N 10.5 .79 4 6.7 .70 4 167 4.9 4 5.7 1.04 4 120 4.1 4 0.15 MEAN S.D. N 10.6 .51 6 6.8 1.05 6 161 4.6 6 5.4 .35 6 118 7.0 6 0.75 MEAN S.D. N 10.8 .41 6 6.4 .94 6 163 5.0 6 5.4 .45 6 117 4.2 6 Covance 6329-223 3M T-6295.7 156 Table 24 Summary of Clinical Chemistry Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 66 20 1.2 9.2 4.7 4.6 .4 S.D. 20.5 2.7 .10 .51 .38 .51 .16 N 6 6 6 6 6 6 6 8 166 1.5 42.0 6 6 67 10.9 6 0.03 MEAN 68 22 1.1 9.0 4.6 4.4 .5 S.D. 14.7 3.3 .08 .69 .19 .54 .27 N 4 4 4 4 4 4 4 8 134 1.4 15.6 4 4 61 14.0 4 0.15 MEAN 60 20 1.0 9.1 4.4 4.6 .4 10 140 56 S.D. 12.4 4.2 .05 .24 .41 .32 .10 5.8 13.1 18.0 N 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 79 22 1.2 9.5 4.8 4.7 .3 11 111 * 60 S.D. 15.5 6.3 .19 .45 .29 .33 .08 7.0 26.6 14.4 N 6 6 6 6 6 6 6 6 6 6 157 Table 24 Summary of Clinical Chemistry Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 44 9.1 6 54 17.9 6 329 128.7 6 110 46.5 6 6 786 370 2.2 947.2 87.4 6 6 6 15 17.5 6 236 62.7 6 0.03 MEAN S.D. N 43 14.6 4 79 26.6 4 233 57.5 4 103 78.3 4 4 220 390 4.4 39.4 99.8 4 4 4 18 10.9 4 269 62.5 4 0.15 MEAN S.D. N 37 11.1 6 67 42.8 6 324 140.3 6 74 19.2 6 4 209 442 2.5 81.8 127.6 6 6 6 40 46.1 6 282 87.7 6 0.75 MEAN S.D. N 34 9.8 6 45 13.0 6 388 150.1 6 63 22.3 6 2* 416 379 .5 377.0 96.5 6 6 6 19 13.6 6 263 59.4 6 158 Table 24 Summary of Clinical Chemistry Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.2 S.D. 1.11 N 6 5.7 .66 6 161 5.9 6 5.6 .74 6 118 6.1 6 0.03 MEAN S.D. N 10.2 1.21 4 4.2 * .44 4 161 7.5 4 5.2 .93 4 117 6.8 4 0.15 MEAN S.D. N 10.0 .53 6 5.2 .63 6 160 3.4 6 5.7 .45 6 120 4.2 6 0.75 MEAN S.D. N 10.6 .58 6 5.1 .53 6 162 4.7 6 5.8 .54 6 118 3.9 6 Covance 6329-223 3M T-6295.7 159 Table 25 Summary of Clinical Chemistry Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 60 20 1.1 8.2 4.8 3.4 .7 10 154 60 69 S.D. 8.0 3.0 .12 .45 .19 .34 .41 1.5 29.9 18.3 10.6 N 6 6 6 6 6 6 6 6 6 6 6 0.03 MEAN 61 19 1.2 8.8 5.2 3.6 .4 S.D. 4.3 2.2 .19 .83 .24 .66 .08 N 4 4 4 4 4 4 4 7 120 1.0 16.3 4 4 60 24.9 4 46 * 4.5 4 0.15 MEAN 63 22 1.2 8.8 5.0 3.8 .5 10 149 65 55 * S.D. 9.4 4.5 .18 .55 .31 .61 .20 2.3 22.8 9.5 12.5 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN S.D. N 76 17.0 6 20 2.2 6 1.3 .20 6 9.0 .23 6 4.9 .48 6 4.1 .43 6 .2 * .05 6 14 5.5 6 65 * 20.3 6 60 26.3 6 19 * 6.5 6 160 Table 25 Summary of Clinical Chemistry Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 31 4.9 6 43 27.3 6 792 305.3 6 142 53.1 6 3 165 392 2.6 28.5 112.8 6 6 6 23 10.5 6 276 74.9 6 0.03 MEAN S.D. N 30 6.3 4 36 19.8 4 684 348.2 4 123 32.2 4 2 133 470 1.5 42.6 165.2 4 4 4 41 40.0 4 339 123.2 4 0.15 MEAN S.D. N 40 15.7 6 55 17.2 6 853 207.5 6 148 63.8 6 4 193 429 166 312 3.1 38.4 69.9 339.9 67.7 6 6 6 6 6 0.75 MEAN S.D. N 39 8.8 6 52 26.6 6 646 384.1 6 112 36.1 6 2 352 * 517 1.2 297.5 124.5 6 6 6 32 17.2 6 364 59.9 6 161 Table 25 Summary of Clinical Chemistry Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.1 S.D. .73 N 6 6.6 .31 6 157 6.1 6 5.4 .48 6 116 4.1 6 0.03 MEAN S.D. N 10.8 .56 4 6.3 1.09 4 159 3.9 4 5.5 .67 4 117 4.1 4 0.15 MEAN S.D. N 10.4 .64 6 6.8 1.01 6 158 3.2 6 5.5 .43 6 115 4.2 6 0.75 MEAN S.D. N 10.8 .76 6 6.8 1.66 6 158 7.9 6 5.8 .73 6 113 7.8 6 Covance 6329-223 3M T-6295.7 162 Table 25 Summary of Clinical Chemistry Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 58 20 1.1 8.9 4.7 4.2 .5 S.D. 9.9 4.0 .14 .80 .47 .63 .27 N 6 6 6 6 6 6 6 9 163 1.3 48.5 6 6 80 47.1 6 59 16.8 6 0.03 MEAN 64 20 1.1 8.6 4.4 4.2 .5 S.D. 12.1 6.0 .17 .25 .40 .29 .34 N 4 4 4 4 4 4 4 8 110 * 1.7 22.1 4 4 82 28.5 4 47 9.5 4 0.15 MEAN 57 22 1.1 8.8 4.5 4.2 .5 10 130 69 41 * S.D. 4.9 3.1 .08 .33 .37 .48 .12 3.1 23.2 13.7 9.2 N 6 6 6 6 6 6 6 6 6 6 6 0.75 MEAN 70 18 1.2 8.9 4.5 4.4 .3 15 91 * 64 23 * S.D. 14.6 5.3 .14 .43 .41 .40 .08 13.8 23.1 13.5 4.3 N 6 6 6 6 6 6 6 6 6 6 6 163 Table 25 Summary of Clinical Chemistry Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 36 8.2 6 77 43.3 6 315 143.3 6 112 51.2 6 2 235 373 .8 105.0 74.3 6 6 6 18 17.7 5 256 55.7 6 0.03 MEAN S.D. N 38 16.2 4 80 52.8 4 262 42.2 4 108 97.8 4 2 255 378 .8 131.7 108.8 4 4 4 18 13.5 4 275 67.7 4 0.15 MEAN S.D. N 36 13.4 6 66 34.1 6 308 120.9 6 72 20.3 6 3 242 432 2.5 116.5 165.5 6 6 6 25 15.2 6 293 129.4 6 0.75 MEAN S.D. N 40 18.1 6 48 10.0 6 336 146.9 6 61 24.2 6 2 695 2.3 1217.1 6 6 380 104.1 6 26 10.9 6 281 76.1 6 164 Table 25 Summary of Clinical Chemistry Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.2 S.D. .87 N 6 5.6 .34 6 158 8.5 6 6.0 .81 6 119 7.2 6 0.03 MEAN S.D. N 9.8 1.04 4 4.1 * .84 4 155 6.9 4 5.6 .46 4 116 6.8 4 0.15 MEAN S.D. N 9.8 .42 6 5.0 .96 6 154 2.2 6 5.4 .52 6 116 3.6 6 0.75 MEAN S.D. N 10.5 .67 6 4.9 .71 6 158 5.0 6 6.3 .75 6 116 4.4 6 Covance 6329-223 3M T-6295.7 165 Table 26 Summary of Clinical Chemistry Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 60 18 1.1 8.2 4.8 3.5 .6 S.D. 6.1 3.9 .16 .54 .23 .40 .23 N 6 6 6 6 6 6 6 6 152 .8 27.5 6 6 45 8.7 6 63 11.1 6 0.03 MEAN S.D. N 64 9.1 4 18 6.3 4 1.2 .16 4 8.8 .65 4 5.0 .34 4 3.8 .47 4 .3 * .08 4 5* 110 * .5 17.0 4 4 33 6.6 4 42 * 3.7 4 0.15 MEAN 70 17 1.1 8.5 4.9 3.6 .4 S.D. 8.3 2.6 .17 .30 .31 .17 .10 N 6 6 6 6 6 6 6 6 147 1.3 24.0 6 6 36 10.4 6 48 14.3 6 0.75 MEAN S.D. N 76 12.6 4 22 4.5 4 1.2 .24 4 9.0 .77 4 4.9 .53 4 4.1 .44 4 .2 * .05 4 18 * 8.6 4 48 * 18.8 4 30 11.8 4 13 * 5.4 4 166 Table 26 Summary of Clinical Chemistry Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 32 6.2 6 39 17.9 6 735 318.7 6 150 65.6 6 6 210 393 3.7 158.7 102.8 6 6 6 29 13.4 6 280 68.5 6 0.03 MEAN S.D. N 27 6.2 4 29 8.8 4 604 353.5 4 126 42.6 4 4 138 442 1.9 58.8 136.5 4 4 4 24 10.6 4 314 96.4 4 0.15 MEAN S.D. N 36 13.3 6 47 16.9 6 688 178.3 6 148 55.8 6 6 174 381 3.8 101.5 82.3 6 6 6 30 11.8 6 270 59.0 6 0.75 MEAN S.D. N 34 5.3 4 47 19.7 4 389 155.7 4 104 25.3 4 3 182 446 1.0 64.5 65.3 4 4 4 36 22.2 4 320 25.2 4 167 Table 26 Summary of Clinical Chemistry Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.2 S.D. .43 N 6 6.4 .82 6 154 4.8 6 5.1 .23 6 111 1.5 6 0.03 MEAN S.D. N 10.0 .20 4 5.8 .96 4 156 1.5 4 5.0 .32 4 109 2.2 4 0.15 MEAN S.D. N 10.1 .41 6 6.2 .82 6 154 4.7 6 5.0 .25 6 110 2.9 6 0.75 MEAN S.D. N 10.3 .62 4 6.1 1.22 4 153 6.4 4 5.4 .17 4 106 5.3 4 Covance 6329-223 3M T-6295.7 168 Table 26 Summary of Clinical Chemistry Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 58 20 1.1 8.9 4.7 4.2 .4 S.D. 15.2 3.7 .18 .66 .42 .55 .25 N 6 6 6 6 6 6 6 6 160 .6 46.5 6 6 56 13.3 6 56 16.0 6 0.03 MEAN 54 20 1.0 8.6 4.4 4.2 .5 S.D. 7.8 3.4 .17 .76 .47 .38 .24 N 4 4 4 4 4 4 4 5 122 1.5 21.6 4 4 49 14.7 4 42 9.1 4 0.15 MEAN 64 19 1.0 8.9 4.5 4.4 .4 S.D. 9.0 3.1 .09 .47 .35 .67 .08 N 6 6 6 6 6 6 6 8 129 2.0 22.3 6 6 49 15.8 6 36 * 12.1 6 0.75 MEAN 73 20 1.2 9.2 4.6 4.7 .2 S.D. 11.0 4.7 .16 .37 .31 .63 .08 N 6 6 6 6 6 6 6 7 82 * 53 21 * 3.4 14.7 15.8 7.2 6 6 6 6 169 Table 26 Summary of Clinical Chemistry Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 41 25.0 6 87 85.9 6 283 137.1 6 114 53.3 6 5 212 378 3.1 123.4 84.6 6 6 6 32 37.1 6 258 64.1 6 0.03 MEAN S.D. N 42 14.6 4 72 26.3 4 239 39.7 4 111 99.5 4 6 823 6.0 1281.8 4 4 358 100.7 4 19 15.0 4 260 64.4 4 0.15 MEAN S.D. N 37 13.0 6 53 36.1 6 254 85.3 6 71 19.7 6 7 182 439 5.2 84.7 140.9 6 6 6 33 21.6 6 294 111.7 6 0.75 MEAN S.D. N 33 6.2 6 44 9.9 6 316 172.4 6 64 22.7 6 3 284 375 1.5 119.3 64.9 6 6 6 31 21.2 6 273 43.1 6 170 Table 26 Summary of Clinical Chemistry Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.2 S.D. .68 N 6 5.3 .84 6 156 6.8 6 5.3 .56 6 111 5.0 6 0.03 MEAN S.D. N 9.6 .84 4 4.4 .39 4 152 7.2 4 4.8 .94 4 109 3.6 4 0.15 MEAN S.D. N 9.8 .16 6 4.8 1.10 6 154 3.3 6 5.0 .37 6 110 1.8 6 0.75 MEAN S.D. N 10.3 .69 6 5.2 .76 6 156 4.9 6 5.4 .82 6 110 3.1 6 Covance 6329-223 3M T-6295.7 171 Table 27 Summary of Clinical Chemistry Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 57 16 1.0 8.0 4.6 3.4 .5 12 132 44 58 S.D. 2.8 4.9 .07 .21 .07 .14 .14 1.4 28.3 .7 12.7 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 70 17 .9 9.0 5.1 3.9 .6 16 158 39 61 S.D. 12.0 .0 .14 .42 .00 .42 .21 .0 37.5 2.8 19.8 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 73 14 1.0 8.7 4.6 4.2 .6 14 137 69 28 S.D. 4.2 2.1 .07 .00 .35 .35 .00 3.5 4.2 32.5 7.8 N 2 2 2 2 2 2 2 2 2 2 2 172 Table 27 Summary of Clinical Chemistry Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 22 3.5 2 26 3.5 2 932 316.1 2 150 123.7 2 4 139 338 .7 77.8 87.7 2 2 2 36 7.8 2 250 58.7 2 0.15 MEAN S.D. N 37 8.5 2 44 2.1 2 793 175.4 2 138 68.6 2 12 1.4 2 162 21.9 2 454 42.4 2 46 2.1 2 288 62.2 2 0.75 MEAN S.D. N 32 4.9 2 48 28.3 2 518 27.6 2 143 22.6 2 2 200 505 .7 32.5 53.7 2 2 2 38 21.2 2 346 23.3 2 173 Table 27 Summary of Clinical Chemistry Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.0 S.D. .57 N 2 6.3 1.13 2 152 2.8 2 5.0 .49 2 111 1.4 2 0.15 MEAN S.D. N 11.0 .78 2 6.6 .00 2 155 1.4 2 5.3 .28 2 108 2.8 2 0.75 MEAN S.D. N 10.8 .21 2 6.2 1.13 2 159 2.8 2 5.4 .07 2 111 1.4 2 Covance 6329-223 3M T-6295.7 174 Table 27 Summary of Clinical Chemistry Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 59 16 .8 8.6 4.6 4.0 .4 14 119 72 54 S.D. 11.3 4.9 .14 .42 .21 .21 .42 1.4 46.7 50.2 29.0 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 76 18 1.0 8.7 4.0 4.6 .6 14 145 56 44 S.D. .7 2.1 .00 .14 .07 .21 .00 .7 4.2 4.9 24.7 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 75 23 1.0 9.3 4.6 4.7 .6 19 133 78 34 S.D. 9.9 2.8 .21 .42 .57 .14 .07 7.1 2.8 21.9 12.0 N 2 2 2 2 2 2 2 2 2 2 2 175 Table 27 Summary of Clinical Chemistry Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 34 .7 2 103 24.0 2 184 33.2 2 61 28.3 2 4 137 343 .7 28.3 48.1 2 2 2 13 18.4 2 244 17.7 2 0.15 MEAN S.D. N 26 9.9 2 48 7.8 2 182 97.6 2 70 2.1 2 4 657 486 4.2 763.7 244.0 2 2 2 32 21.9 2 350 163.3 2 0.75 MEAN S.D. N 23 .0 2 50 16.3 2 220 29.0 2 94 37.5 2 4 165 345 2.1 29.7 69.3 2 2 2 38 4.2 2 256 47.4 2 176 Table 27 Summary of Clinical Chemistry Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN S.D. N 9.8 .14 2 4.8 1.56 2 148 4.9 2 5.4 .64 2 108 6.4 2 0.15 MEAN S.D. N 9.8 .14 2 5.5 .28 2 152 3.5 2 5.5 .00 2 110 2.1 2 0.75 MEAN S.D. N 10.3 .14 2 5.8 .64 2 152 .0 2 5.0 .21 2 110 2.1 2 Covance 6329-223 3M T-6295.7 177 Table 28 Summary of Clinical Chemistry Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 101 16 1.1 8.7 4.8 3.8 .4 S.D. 21.2 1.4 .14 .14 .07 .07 .07 N 2 2 2 2 2 2 2 8 134 .7 29.0 2 2 33 7.1 2 77 5.7 2 0.15 MEAN 81 17 1.1 9.0 5.2 3.8 .6 S.D. 2.8 .0 .14 .14 .07 .07 .28 N 2 2 2 2 2 2 2 8 160 4.2 46.0 2 2 48 5.7 2 84 26.9 2 0.75 MEAN 72 17 1.0 8.8 4.6 4.2 .4 11 136 64 52 S.D. 16.3 1.4 .00 .35 .35 .00 .00 5.7 4.9 10.6 2.1 N 2 2 2 2 2 2 2 2 2 2 2 178 Table 28 Summary of Clinical Chemistry Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 27 4.2 2 28 .7 2 900 334.5 2 144 107.5 2 4 177 358 2.8 45.3 72.1 2 2 2 42 13.4 2 270 50.9 2 0.15 MEAN S.D. N 34 21.2 2 40 .0 2 838 62.9 2 142 62.2 2 4 156 462 3.5 46.0 57.3 2 2 2 37 21.2 2 297 79.2 2 0.75 MEAN S.D. N 46 4.9 2 53 28.3 2 680 78.5 2 166 14.1 2 4 257 544 3.5 111.7 118.8 2 2 2 32 21.9 2 372 54.4 2 179 Table 28 Summary of Clinical Chemistry Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.2 S.D. .35 N 2 6.6 .64 2 154 3.5 2 5.0 .00 2 117 .0 2 0.15 MEAN S.D. N 10.9 .57 2 6.6 .21 2 160 .7 2 5.2 .07 2 117 1.4 2 0.75 MEAN S.D. N 10.8 .64 2 7.0 1.13 2 162 3.5 2 5.2 .28 2 116 2.8 2 Covance 6329-223 3M T-6295.7 180 Table 28 Summary of Clinical Chemistry Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 58 18 1.0 9.0 4.6 4.4 .6 S.D. 14.1 3.5 .35 .64 .14 .49 .35 N 2 2 2 2 2 2 2 9 131 1.4 52.3 2 2 57 5.7 2 70 25.5 2 0.15 MEAN 87 20 1.0 9.0 4.1 4.9 .4 11 150 71 72 S.D. 5.7 1.4 .14 .28 .14 .14 .14 1.4 17.7 1.4 27.6 N 2 2 2 2 2 2 2 2 2 2 2 0.75 MEAN 92 22 1.2 9.4 4.7 4.7 .2 15 149 95 64 S.D. .7 .0 .07 .57 .42 .14 .07 5.7 2.8 48.1 13.4 N 2 2 2 2 2 2 2 2 2 2 2 181 Table 28 Summary of Clinical Chemistry Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 36 9.2 2 116 59.4 2 182 30.4 2 58 20.5 2 2 168 329 .7 50.9 48.1 2 2 2 10 14.8 2 242 27.6 2 0.15 MEAN S.D. N 30 9.2 2 66 7.1 2 188 105.4 2 80 4.2 2 3 392 482 2.8 384.0 242.5 2 2 2 34 17.7 2 346 157.7 2 0.75 MEAN S.D. N 25 4.2 2 40 1.4 2 236 17.7 2 98 33.2 2 2 148 331 .7 27.6 76.4 2 2 2 66 66.5 2 250 54.4 2 182 Table 28 Summary of Clinical Chemistry Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN S.D. N 9.7 .14 2 4.6 .28 2 150 4.2 2 4.6 .21 2 114 4.9 2 0.15 MEAN S.D. N 9.8 .49 2 5.4 .28 2 152 4.9 2 5.4 .71 2 118 2.1 2 0.75 MEAN S.D. N 10.6 .57 2 5.4 .71 2 160 7.8 2 5.5 .99 2 120 6.4 2 Covance 6329-223 3M T-6295.7 183 Table 29 Summary of Clinical Chemistry Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 67 16 1.2 8.5 4.7 3.8 .4 S.D. 18.4 3.5 .14 .42 .14 .28 .42 N 2 2 2 2 2 2 2 2 130 .7 26.2 2 2 36 15.6 2 64 14.8 2 0.15 MEAN 74 19 1.0 8.8 5.0 3.8 .4 S.D. 2.8 1.4 .14 .21 .21 .00 .14 N 2 2 2 2 2 2 2 9 168 2.8 50.2 2 2 48 13.4 2 76 26.2 2 0.75 MEAN 70 18 1.2 8.8 4.8 4.0 .3 S.D. 9.2 3.5 .21 .07 .42 .35 .14 N 2 2 2 2 2 2 2 8 139 3.5 5.7 2 2 74 23.3 2 40 7.1 2 184 Table 29 Summary of Clinical Chemistry Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 28 12.7 2 35 5.7 2 842 409.4 2 124 90.5 2 7 176 318 4.2 35.4 71.4 2 2 2 36 7.1 2 239 53.7 2 0.15 MEAN S.D. N 26 6.4 2 39 4.2 2 850 105.4 2 146 70.0 2 4 141 444 2.8 22.6 43.1 2 2 2 39 2.8 2 285 75.0 2 0.75 MEAN S.D. N 38 3.5 2 54 21.2 2 689 186.7 2 164 7.8 2 4 230 512 .7 89.8 84.1 2 2 2 35 24.0 2 354 32.5 2 185 Table 29 Summary of Clinical Chemistry Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.2 S.D. .21 N 2 6.0 1.13 2 154 4.9 2 5.8 .21 2 116 .7 2 0.15 MEAN S.D. N 11.2 1.20 2 6.4 .21 2 159 7.1 2 5.6 .35 2 118 6.4 2 0.75 MEAN S.D. N 11.2 .57 2 6.4 .92 2 160 3.5 2 5.6 .35 2 114 2.1 2 Covance 6329-223 3M T-6295.7 186 Table 29 Summary of Clinical Chemistry Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 56 20 .8 8.7 4.4 4.3 .6 S.D. 15.6 4.9 .00 .85 .28 .57 .57 N 2 2 2 2 2 2 2 8 129 2.1 58.0 2 2 48 7.8 2 62 26.2 2 0.15 MEAN 74 21 .9 8.9 4.0 4.9 .4 S.D. 4.9 2.8 .14 .28 .00 .28 .21 N 2 2 2 2 2 2 2 5 144 .0 6.4 2 2 59 11.3 2 52 22.6 2 0.75 MEAN 92 23 1.0 9.0 4.4 4.6 .1 S.D. 3.5 4.2 .14 .35 .42 .07 .00 N 2 2 2 2 2 2 2 6 144 2.1 .7 2 2 70 31.8 2 56 4.2 2 187 Table 29 Summary of Clinical Chemistry Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 40 9.9 2 104 34.6 2 163 35.4 2 58 17.7 2 3 301 309 1.4 189.5 26.9 2 2 2 9 12.7 2 225 9.9 2 0.15 MEAN S.D. N 37 14.1 2 58 2.1 2 172 94.0 2 76 .7 2 9 1214 7.1 1557.8 2 2 468 256.0 2 74 33.9 2 340 177.5 2 0.75 MEAN S.D. N 29 18.4 2 44 10.6 2 226 25.5 2 87 29.7 2 5 142 316 1.4 31.8 113.8 2 2 2 32 2.1 2 236 83.4 2 188 Table 29 Summary of Clinical Chemistry Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN S.D. N 9.8 .78 2 4.4 .28 2 150 7.8 2 5.0 .92 2 110 4.9 2 0.15 MEAN S.D. N 9.5 .00 2 5.2 .07 2 150 2.8 2 4.8 .92 2 111 5.7 2 0.75 MEAN S.D. N 10.4 .00 2 5.2 .85 2 156 2.1 2 6.0 .07 2 119 2.8 2 Covance 6329-223 3M T-6295.7 189 Table 30 Summary of Clinical Chemistry Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 71 18 1.2 8.6 4.8 3.8 .4 S.D. 4.2 2.1 .07 .07 .14 .07 .57 N 2 2 2 2 2 2 2 6 134 .7 34.6 2 2 52 21.9 2 69 17.0 2 0.15 MEAN 62 28 1.4 8.7 5.1 3.6 .7 S.D. 23.3 2.8 .21 .42 .14 .28 .71 N 2 2 2 2 2 2 2 7 163 1.4 65.1 2 2 61 18.4 2 72 26.2 2 0.75 MEAN 66 18 1.4 8.6 4.7 3.8 .4 S.D. 14.8 .7 .35 .49 .42 .07 .28 N 2 2 2 2 2 2 2 8 136 2.1 .7 2 2 90 51.6 2 39 7.1 2 190 Table 30 Summary of Clinical Chemistry Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 38 5.7 2 38 6.4 2 772 386.8 2 124 105.4 2 4 966 487 1.4 149.2 35.4 2 2 2 94 5.7 2 366 19.8 2 0.15 MEAN S.D. N 53 9.9 2 68 7.1 2 882 159.1 2 140 68.6 2 6 570 1297 710 962 .0 77.1 454.0 227.7 326.7 2 2 2 2 2 0.75 MEAN S.D. N 61 21.2 2 76 23.3 2 708 191.6 2 157 1.4 2 2 1048 1.4 368.4 2 2 625 144.2 2 30 7.8 2 442 85.6 2 191 Table 30 Summary of Clinical Chemistry Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.4 S.D. .49 N 2 5.4 .57 2 150 3.5 2 5.0 .14 2 106 .7 2 0.15 MEAN S.D. N 11.0 .92 2 5.8 .64 2 154 .0 2 5.0 .07 2 106 2.8 2 0.75 MEAN S.D. N 10.6 .92 2 5.8 1.13 2 154 4.9 2 5.4 .35 2 108 .0 2 Covance 6329-223 3M T-6295.7 192 Table 30 Summary of Clinical Chemistry Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 54 15 1.2 8.4 4.4 4.1 .5 10 118 42 58 S.D. 14.1 1.4 .21 .07 .07 .14 .57 4.9 41.7 8.5 23.3 N 2 2 2 2 2 2 2 2 2 2 2 0.15 MEAN 64 28 1.3 8.8 3.9 4.8 .5 S.D. 7.8 .7 .14 .78 .14 .64 .00 N 2 2 2 2 2 2 2 8 148 3.5 9.2 2 2 86 23.3 2 60 19.8 2 0.75 MEAN 85 18 1.5 8.7 4.3 4.4 .0 S.D. 1.4 9.2 .14 .64 .42 .21 .07 N 2 2 2 2 2 2 2 6 129 2.1 14.1 2 2 74 9.2 2 60 .0 2 193 Table 30 Summary of Clinical Chemistry Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 56 14.1 2 87 14.1 2 156 18.4 2 60 30.4 2 4 1118 2.1 132.9 2 2 366 33.9 2 0 268 .0 12.0 2 2 0.15 MEAN S.D. N 48 17.0 2 78 9.9 2 160 64.3 2 73 8.5 2 6 1058 3.5 644.2 2 2 554 237.6 2 73 14.1 2 406 166.9 2 0.75 MEAN S.D. N 44 2.1 2 112 60.1 2 235 21.2 2 80 35.4 2 2 1065 .7 574.2 2 2 449 1.4 2 64 43.1 2 338 1.4 2 194 Table 30 Summary of Clinical Chemistry Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN S.D. N 9.7 .14 2 4.7 .42 2 147 1.4 2 5.0 .21 2 104 4.9 2 0.15 MEAN S.D. N 9.8 .57 2 5.2 .49 2 151 4.2 2 5.2 .07 2 108 1.4 2 0.75 MEAN S.D. N 10.3 .00 2 4.2 .21 2 156 2.8 2 5.5 .42 2 110 1.4 2 Covance 6329-223 3M T-6295.7 195 Table 31 Summary of Clinical Chemistry Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 72 20 1.3 8.9 5.2 3.8 .5 S.D. 2.1 4.9 .00 .00 .21 .21 .28 N 2 2 2 2 2 2 2 6 126 .7 30.4 2 2 40 7.8 2 61 14.1 2 0.15 MEAN 74 26 1.2 8.6 5.2 3.4 .8 S.D. 2.1 3.5 .07 .64 .35 .28 .42 N 2 2 2 2 2 2 2 6 166 .7 55.9 2 2 48 21.9 2 74 27.6 2 0.75 MEAN 70 18 1.2 8.4 4.8 3.6 .4 S.D. 9.2 1.4 .14 .14 .35 .21 .21 N 2 2 2 2 2 2 2 4 119 2.1 4.2 2 2 51 21.2 2 38 4.9 2 196 Table 31 Summary of Clinical Chemistry Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 50 4.9 2 42 4.9 2 714 461.7 2 138 119.5 2 6 2137 3.5 19.8 2 2 376 17.7 2 38 .7 2 272 36.8 2 0.15 MEAN S.D. N 60 6.4 2 66 4.9 2 820 134.4 2 143 63.6 2 8 1495 1294 .7 356.4 489.3 2 2 2 579 302.6 2 958 351.4 2 0.75 MEAN S.D. N 60 2.8 2 66 25.5 2 622 202.2 2 155 1.4 2 4 1310 2.8 980.8 2 2 516 142.1 2 33 2.8 2 358 79.2 2 197 Table 31 Summary of Clinical Chemistry Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.6 S.D. .49 N 2 4.7 .71 2 156 2.1 2 5.4 .14 2 111 .0 2 0.15 MEAN S.D. N 10.9 1.41 2 5.6 .14 2 155 7.1 2 5.4 .49 2 111 2.8 2 0.75 MEAN S.D. N 10.6 .49 2 4.9 .42 2 154 2.1 2 5.4 .64 2 110 3.5 2 Covance 6329-223 3M T-6295.7 198 Table 31 Summary of Clinical Chemistry Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 55 20 1.0 9.0 4.7 4.2 .8 S.D. 1.4 2.1 .14 .07 .00 .07 .49 N 2 2 2 2 2 2 2 6 137 .7 35.4 2 2 49 9.9 2 60 27.6 2 0.15 MEAN 73 24 1.0 8.7 3.9 4.8 .8 S.D. 9.9 2.8 .07 .57 .14 .42 .07 N 2 2 2 2 2 2 2 6 137 .0 1.4 2 2 54 16.3 2 54 24.7 2 0.75 MEAN 88 23 1.2 8.7 4.4 4.2 .4 S.D. 4.2 2.8 .07 .78 .64 .14 .07 N 2 2 2 2 2 2 2 9 142 5.7 14.8 2 2 75 28.3 2 60 7.8 2 199 Table 31 Summary of Clinical Chemistry Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 86 34.6 2 202 135.1 2 162 7.1 2 77 45.3 2 6 2408 1.4 806.1 2 2 398 85.6 2 16 23.3 2 300 50.2 2 0.15 MEAN S.D. N 50 17.7 2 78 24.0 2 148 55.9 2 79 1.4 2 12 4.9 2 871 195.2 2 467 230.5 2 47 7.1 2 345 161.2 2 0.75 MEAN S.D. N 56 15.6 2 80 3.5 2 228 21.2 2 86 43.1 2 4 1797 1.4 786.3 2 2 479 67.9 2 47 .0 2 370 58.7 2 200 Table 31 Summary of Clinical Chemistry Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN S.D. N 9.9 .28 2 4.9 .99 2 148 4.9 2 5.0 .92 2 106 4.2 2 0.15 MEAN S.D. N 9.4 .64 2 4.8 .07 2 148 3.5 2 5.4 .71 2 110 2.1 2 0.75 MEAN S.D. N 10.2 .35 2 4.4 .21 2 155 2.8 2 5.4 .21 2 112 1.4 2 Covance 6329-223 3M T-6295.7 201 Table 32 Summary of Clinical Chemistry Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 74 14 1.2 8.7 5.0 3.6 .6 S.D. 8.5 2.8 .00 .28 .21 .07 .35 N 2 2 2 2 2 2 2 3 132 .0 14.1 2 2 32 .7 2 58 3.5 2 0.15 MEAN 91 16 1.2 9.1 5.4 3.6 .4 S.D. 4.2 1.4 .07 .28 .07 .35 .21 N 2 2 2 2 2 2 2 6 178 .7 54.4 2 2 41 2.8 2 80 36.1 2 0.75 MEAN 70 14 1.2 8.9 5.0 4.0 .6 S.D. 7.8 .7 .21 .57 .64 .07 .35 N 2 2 2 2 2 2 2 4 118 .7 5.7 2 2 59 31.1 2 35 12.7 2 202 Table 32 Summary of Clinical Chemistry Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 24 7.1 2 24 3.5 2 620 320.3 2 124 91.9 2 6 102 298 5.7 34.6 30.4 2 2 2 16 7.1 2 233 18.4 2 0.15 MEAN S.D. N 25 5.7 2 46 .7 2 871 141.4 2 150 68.6 2 2 141 450 .7 31.1 52.3 2 2 2 16 2.1 2 294 83.4 2 0.75 MEAN S.D. N 34 4.9 2 41 12.7 2 418 55.9 2 138 13.4 2 0 202 422 .7 32.5 82.0 2 2 2 16 4.9 2 294 44.5 2 203 Table 32 Summary of Clinical Chemistry Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.2 S.D. .21 N 2 6.0 .49 2 153 4.2 2 5.4 .42 2 111 2.8 2 0.15 MEAN S.D. N 11.8 1.20 2 6.9 .42 2 164 4.2 2 6.0 .49 2 116 3.5 2 0.75 MEAN S.D. N 10.6 .78 2 5.3 1.98 2 155 4.2 2 5.0 .57 2 111 2.8 2 Covance 6329-223 3M T-6295.7 204 Table 32 Summary of Clinical Chemistry Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 64 17 1.0 8.5 4.6 3.9 .6 S.D. 21.9 .0 .07 .28 .00 .28 .49 N 2 2 2 2 2 2 2 6 120 2.1 30.4 2 2 56 5.7 2 50 23.3 2 0.15 MEAN 78 17 1.0 8.7 4.1 4.6 .6 S.D. .7 1.4 .07 .42 .00 .42 .07 N 2 2 2 2 2 2 2 5 144 1.4 .0 2 2 71 17.0 2 47 15.6 2 0.75 MEAN 100 19 1.0 8.7 4.5 4.2 .2 S.D. 2.1 2.8 .07 .64 .57 .07 .07 N 2 2 2 2 2 2 2 4 138 1.4 1.4 2 2 78 50.9 2 64 12.0 2 205 Table 32 Summary of Clinical Chemistry Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 43 18.4 2 134 69.3 2 156 24.7 2 72 33.2 2 4 222 268 2.1 31.1 34.6 2 2 2 10 2.1 2 204 17.0 2 0.15 MEAN S.D. N 32 10.6 2 50 22.6 2 140 65.1 2 78 3.5 2 7 183 339 4.2 100.4 137.2 2 2 2 13 2.8 2 250 87.0 2 0.75 MEAN S.D. N 25 .0 2 54 14.8 2 232 22.6 2 94 43.1 2 2 124 296 2.1 14.1 89.8 2 2 2 18 7.1 2 230 66.5 2 206 Table 32 Summary of Clinical Chemistry Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN S.D. N 9.9 .42 2 5.2 .35 2 148 5.7 2 5.0 .14 2 108 3.5 2 0.15 MEAN S.D. N 9.8 .42 2 5.2 .21 2 152 1.4 2 5.6 .35 2 112 .7 2 0.75 MEAN S.D. N 10.4 .14 2 5.4 .35 2 154 .7 2 6.2 .85 2 116 2.8 2 Covance 6329-223 3M T-6295.7 207 Table 33 Summary of Clinical Chemistry Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 82 16 1.2 8.8 4.7 4.1 .4 S.D. 4.9 2.8 .07 .14 .14 .00 .21 N 2 2 2 2 2 2 2 6 134 .7 21.9 2 2 31 1.4 2 70 9.9 2 0.15 MEAN 79 19 1.2 8.8 5.1 3.7 .4 S.D. 2.8 .0 .07 .28 .28 .00 .21 N 2 2 2 2 2 2 2 4 166 1.4 48.1 2 2 36 6.4 2 92 31.8 2 0.75 MEAN 79 16 1.4 9.4 5.1 4.3 .6 S.D. 5.7 .0 .00 .14 .14 .28 .35 N 2 2 2 2 2 2 2 7 138 4.2 9.2 2 2 44 10.6 2 57 14.1 2 208 Table 33 Summary of Clinical Chemistry Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 24 6.4 2 25 7.1 2 505 277.2 2 116 94.8 2 10 12.7 2 111 46.7 2 262 4.2 2 14 4.9 2 202 1.4 2 0.15 MEAN S.D. N 30 .7 2 34 2.1 2 754 130.1 2 136 60.1 2 3 171 402 2.8 58.0 62.9 2 2 2 12 .7 2 264 81.3 2 0.75 MEAN S.D. N 36 12.7 2 40 3.5 2 404 88.4 2 148 1.4 2 0 165 440 .0 .0 111.0 2 2 2 16 7.8 2 297 52.3 2 209 Table 33 Summary of Clinical Chemistry Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.6 S.D. .21 N 2 6.6 .07 2 160 3.5 2 6.0 .57 2 116 6.4 2 0.15 MEAN S.D. N 11.2 .28 2 7.0 .92 2 166 3.5 2 6.4 .78 2 120 3.5 2 0.75 MEAN S.D. N 11.9 .14 2 5.8 .57 2 172 3.5 2 6.1 .14 2 118 3.5 2 Covance 6329-223 3M T-6295.7 210 Table 33 Summary of Clinical Chemistry Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE mg/kg/day GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL SBA UMOL/L CHOL MG/DL TRIG MG/DL HDL MG/DL ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 60 16 1.0 8.5 4.4 4.1 .6 S.D. 9.9 .7 .07 .42 .00 .42 .35 N 2 2 2 2 2 2 2 6 124 .7 39.6 2 2 53 2.8 2 64 27.6 2 0.15 MEAN 72 18 1.0 8.4 3.8 4.6 .6 S.D. 2.1 1.4 .21 .21 .21 .00 .07 N 2 2 2 2 2 2 2 5 138 .0 12.7 2 2 60 19.1 2 62 34.6 2 0.75 MEAN 96 19 1.2 8.4 4.3 4.2 .3 S.D. 4.9 .0 .00 .78 .42 .35 .00 N 2 2 2 2 2 2 2 5 146 1.4 1.4 2 2 76 50.9 2 74 7.8 2 211 Table 33 Summary of Clinical Chemistry Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS Covance 6329-223 3M T-6295.7 DOSE AST/SGOT ALT/SGPT ALK PHOS mg/kg/day IU/L IU/L IU/L GGT IU/L SDH IU/L CK IU/L AMYLASE IU/L LIPASE IU/L P AMYL U/L ------ -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 42 16.3 2 120 100.4 2 151 28.3 2 69 33.9 2 0 154 280 .0 87.0 50.2 2 2 2 12 .7 2 212 28.3 2 0.15 MEAN S.D. N 26 .7 2 34 4.2 2 146 70.0 2 79 4.2 2 2 94 353 11 261 .7 20.5 142.8 4.2 93.3 2 2 2 2 2 0.75 MEAN S.D. N 28 12.0 2 59 28.3 2 213 38.2 2 89 39.6 2 2 130 311 2.1 47.4 86.3 2 2 2 15 4.2 2 240 64.3 2 212 Table 33 Summary of Clinical Chemistry Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L ------ -------- -------- -------- -------- -------- 0 MEAN 10.1 S.D. .00 N 2 5.4 .28 2 151 1.4 2 5.2 .14 2 110 2.1 2 0.15 MEAN S.D. N 10.0 .28 2 5.2 .35 2 156 1.4 2 5.8 .49 2 114 3.5 2 0.75 MEAN S.D. N 10.5 .28 2 5.6 .35 2 162 4.2 2 6.2 .78 2 120 6.4 2 Covance 6329-223 3M T-6295.7 213 Table 34 Summary of Clinical Urinalysis Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 41.5 1.026 S.D. 17.76 .0050 N 6 6 7.3 .75 6 0.03 MEAN S.D. N 52.5 10.15 4 1.021 .0021 4 7.4 .48 4 0.15 MEAN S.D. N 97.8 71.41 6 1.019 .0078 6 7.1 .20 6 0.75 MEAN S.D. N 83.5 46.63 6 1.018 .0066 6 7.2 .26 6 Covance 6329-223 3M T-6295.7 214 Table 34 Summary of Clinical Urinalysis Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 90.7 1.018 S.D. 75.84 .0060 N 6 6 7.3 .41 6 0.03 MEAN S.D. N 92.5 88.38 4 1.019 .0082 4 7.1 .25 4 0.15 MEAN S.D. N 71.8 33.80 6 1.021 .0052 6 7.8 .42 6 0.75 MEAN S.D. N 88.0 78.91 6 1.020 .0068 6 7.3 .41 6 Covance 6329-223 3M T-6295.7 215 Table 35 Summary of Clinical Urinalysis Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 50.2 1.018 S.D. 13.75 .0071 N 6 6 7.5 .45 6 0.03 MEAN S.D. N 72.5 29.73 4 1.021 .0048 4 7.5 .41 4 0.15 MEAN S.D. N 94.3 105.16 6 1.019 .0092 6 7.2 .27 6 0.75 MEAN S.D. N 79.0 42.12 6 1.018 .0082 6 7.3 .75 6 Covance 6329-223 3M T-6295.7 216 Table 35 Summary of Clinical Urinalysis Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 118.5 1.014 S.D. 218.53 .0103 N 6 6 8.0 .32 6 0.03 MEAN S.D. N 86.8 56.91 4 1.018 .0056 4 7.8 .29 4 0.15 MEAN S.D. N 83.7 53.05 6 1.017 .0076 6 7.5 .32 6 0.75 MEAN S.D. N 100.2 155.27 6 1.022 .0094 6 7.8 .61 6 Covance 6329-223 3M T-6295.7 217 Table 36 Summary of Clinical Urinalysis Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 77.5 1.018 S.D. 50.66 .0054 N 6 6 8.0 .32 6 0.03 MEAN S.D. N 62.2 34.86 4 1.018 .0076 4 8.0 .41 4 0.15 MEAN S.D. N 94.5 59.43 6 1.015 .0095 6 7.8 .42 6 0.75 MEAN S.D. N 68.0 26.39 6 1.017 .0051 6 7.9 .38 6 Covance 6329-223 3M T-6295.7 218 Table 36 Summary of Clinical Urinalysis Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 74.3 1.019 S.D. 61.32 .0076 N 6 6 8.2 .26 6 0.03 MEAN S.D. N 53.5 32.58 4 1.020 .0056 4 7.6 .48 4 0.15 MEAN S.D. N 62.3 28.86 6 1.020 .0061 6 7.8 .26 6 0.75 MEAN S.D. N 81.0 51.27 6 1.017 .0091 6 7.6 * .38 6 Covance 6329-223 3M T-6295.7 219 Table 37 Summary of Clinical Urinalysis Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 47.5 1.024 S.D. 7.31 .0046 N 6 6 7.5 .77 6 0.03 MEAN S.D. N 65.8 40.43 4 1.018 .0062 4 7.8 .29 4 0.15 MEAN S.D. N 101.2 73.16 6 1.014 * .0061 6 7.4 .49 6 0.75 MEAN S.D. N 54.0 19.47 6 1.020 .0066 6 7.2 .88 6 Covance 6329-223 3M T-6295.7 220 Table 37 Summary of Clinical Urinalysis Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 93.3 1.015 S.D. 68.15 .0053 N 6 6 8.0 .00 6 0.03 MEAN S.D. N 64.8 30.02 4 1.018 .0034 4 7.4 .48 4 0.15 MEAN S.D. N 63.2 22.56 6 1.018 .0073 6 7.5 .63 6 0.75 MEAN S.D. N 120.5 125.14 6 1.017 .0096 6 7.8 .42 6 Covance 6329-223 3M T-6295.7 221 Table 38 Summary of Clinical Urinalysis Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 131.3 1.013 S.D. 110.42 .0072 N 6 6 7.1 .49 6 0.03 MEAN S.D. N 55.0 21.32 4 1.020 .0052 4 7.4 .48 4 0.15 MEAN S.D. N 137.8 114.54 6 1.011 .0062 6 7.1 .20 6 0.75 MEAN S.D. N 180.0 136.48 6 1.011 .0082 6 7.1 .58 6 Covance 6329-223 3M T-6295.7 222 Table 38 Summary of Clinical Urinalysis Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 85.2 1.016 S.D. 53.91 .0084 N 6 6 7.5 .32 6 0.03 MEAN S.D. N 60.5 36.93 4 1.016 .0029 4 7.0 .41 4 0.15 MEAN S.D. N 40.7 11.15 6 1.022 .0040 6 7.1 .20 6 0.75 MEAN S.D. N 89.0 93.46 6 1.017 .0085 6 7.1 .66 6 Covance 6329-223 3M T-6295.7 223 Table 39 Summary of Clinical Urinalysis Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 116.2 1.014 S.D. 79.33 .0072 N 6 6 7.9 .20 6 0.03 MEAN S.D. N 75.5 26.20 4 1.017 .0022 4 7.9 .25 4 0.15 MEAN S.D. N 122.3 125.43 6 1.013 .0053 6 7.5 1.00 6 0.75 MEAN S.D. N 121.0 108.83 4 1.013 .0059 4 7.2 .65 4 Covance 6329-223 3M T-6295.7 224 Table 39 Summary of Clinical Urinalysis Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 85.7 1.016 S.D. 40.59 .0050 N 6 6 8.1 .20 6 0.03 MEAN S.D. N 76.2 31.48 4 1.016 .0054 4 7.6 .48 4 0.15 MEAN S.D. N 73.3 25.33 6 1.017 .0055 6 7.9 .20 6 0.75 MEAN S.D. N 131.8 156.54 6 1.014 .0058 6 7.8 .26 6 Covance 6329-223 3M T-6295.7 225 Table 40 Summary of Clinical Urinalysis Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 179.5 1.010 S.D. 24.75 .0000 N 2 2 7.2 .35 2 0.15 MEAN S.D. N 239.5 79.90 2 1.007 .0028 2 7.5 .00 2 0.75 MEAN S.D. N 87.5 36.06 2 1.013 .0028 2 7.0 .71 2 Covance 6329-223 3M T-6295.7 226 Table 40 Summary of Clinical Urinalysis Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 143.0 1.014 S.D. 77.78 .0078 N 2 2 7.8 .35 2 0.15 MEAN S.D. N 121.0 80.61 2 1.015 .0000 2 7.2 .35 2 0.75 MEAN S.D. N 89.0 36.77 2 1.015 .0000 2 7.5 .71 2 Covance 6329-223 3M T-6295.7 227 Table 41 Summary of Clinical Urinalysis Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 195.5 1.009 S.D. 9.19 .0014 N 2 2 7.8 .35 2 0.15 MEAN S.D. N 196.0 132.94 2 1.010 .0064 2 7.5 .00 2 0.75 MEAN S.D. N 83.0 29.70 2 1.017 .0042 2 7.8 .35 2 Covance 6329-223 3M T-6295.7 228 Table 41 Summary of Clinical Urinalysis Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 117.0 1.018 S.D. 100.41 .0113 N 2 2 8.0 .00 2 0.15 MEAN S.D. N 131.5 62.93 2 1.016 .0021 2 7.2 .35 2 0.75 MEAN S.D. N 91.5 48.79 2 1.016 .0035 2 7.8 .35 2 Covance 6329-223 3M T-6295.7 229 Table 42 Summary of Clinical Urinalysis Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 284.0 1.004 S.D. 50.91 .0007 N 2 2 6.8 .35 2 0.15 MEAN S.D. N 234.0 169.71 2 1.007 .0042 2 7.2 .35 2 0.75 MEAN S.D. N 67.5 50.20 2 1.018 .0106 2 7.0 .71 2 Covance 6329-223 3M T-6295.7 230 Table 42 Summary of Clinical Urinalysis Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 141.5 1.006 S.D. 33.23 .0014 N 2 2 7.8 .35 2 0.15 MEAN S.D. N 63.5 37.48 2 1.020 .0050 2 7.5 .00 2 0.75 MEAN S.D. N 64.5 58.69 2 1.010 .0007 2 7.2 1.06 2 Covance 6329-223 3M T-6295.7 231 Table 43 Summary of Clinical Urinalysis Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 296.0 1.008 S.D. 254.56 .0092 N 2 2 6.8 .35 2 0.15 MEAN S.D. N 99.5 94.05 2 1.016 .0099 2 6.5 .71 2 0.75 MEAN S.D. N 47.5 4.95 2 1.020 .0092 2 6.0 .00 2 Covance 6329-223 3M T-6295.7 232 Table 43 Summary of Clinical Urinalysis Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 220.5 1.006 S.D. 188.80 .0050 N 2 2 8.0 .00 2 0.15 MEAN S.D. N 59.0 24.04 2 1.018 .0042 2 6.5 .71 2 0.75 MEAN S.D. N 92.0 29.70 2 1.014 .0035 2 6.8 .35 2 Covance 6329-223 3M T-6295.7 233 Table 44 Summary of Clinical Urinalysis Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 206.5 1.017 S.D. 81.32 .0028 N 2 2 7.8 .35 2 0.15 MEAN S.D. N 74.5 10.61 2 1.018 .0000 2 7.5 .71 2 0.75 MEAN S.D. N 90.0 14.14 2 1.018 .0050 2 6.8 1.06 2 Covance 6329-223 3M T-6295.7 234 Table 44 Summary of Clinical Urinalysis Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 158.0 1.011 S.D. 11.31 .0000 N 2 2 8.0 .00 2 0.15 MEAN S.D. N 68.5 13.44 2 1.021 .0014 2 7.0 .00 2 0.75 MEAN S.D. N 76.0 46.67 2 1.018 .0007 2 7.0 .71 2 Covance 6329-223 3M T-6295.7 235 Table 45 Summary of Clinical Urinalysis Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 185.0 1.010 S.D. 120.21 .0028 N 2 2 8.0 .00 2 0.15 MEAN S.D. N 182.0 147.08 2 1.008 .0050 2 8.0 .00 2 0.75 MEAN S.D. N 84.0 8.49 2 1.012 .0050 2 8.0 .00 2 Covance 6329-223 3M T-6295.7 236 Table 45 Summary of Clinical Urinalysis Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 214.0 1.009 S.D. 164.05 .0057 N 2 2 8.0 .00 2 0.15 MEAN S.D. N 145.0 74.95 2 1.011 .0042 2 7.8 .35 2 0.75 MEAN S.D. N 118.0 82.02 2 1.005 .0042 2 8.0 .00 2 Covance 6329-223 3M T-6295.7 237 Table 46 Summary of Clinical Urinalysis Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 430.0 1.005 S.D. 70.71 .0000 N 2 2 8.0 .00 2 0.15 MEAN S.D. N 300.0 148.49 2 1.006 .0028 2 7.8 .35 2 0.75 MEAN S.D. N 222.5 173.24 2 1.010 .0071 2 8.0 .00 2 Covance 6329-223 3M T-6295.7 238 Table 46 Summary of Clinical Urinalysis Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day U VOL ML SP GR U PH ------ -------- -------- -------- 0 MEAN 132.5 1.011 S.D. 38.89 .0057 N 2 2 8.0 .00 2 0.15 MEAN S.D. N 67.5 24.75 2 1.018 .0014 2 8.0 .00 2 0.75 MEAN S.D. N 99.0 80.61 2 1.014 .0050 2 8.0 .00 2 Covance 6329-223 3M T-6295.7 239 Table 47 Summary of Palmitoyl CoA Oxidase Determinations Terminal Sacrifice Males 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day PCOAO IU/G ------ -------- 0 MEAN 5 S.D. 1.5 N 4 0.03 MEAN 5 S.D. 1.0 N 4 0.15 MEAN 6 S.D. .6 N 4 0.75 MEAN 7 S.D. 1.4 N 2 Covance 6329-223 3M T-6295.7 240 Table 47 Summary of Palmitoyl CoA Oxidase Determinations Terminal Sacrifice Females 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS DOSE mg/kg/day PCOAO IU/G ------ -------- 0 MEAN 4 S.D. .8 N 4 0.03 MEAN 4 S.D. 1.3 N 4 0.15 MEAN 6 S.D. 1.0 N 4 0.75 MEAN 6* S.D. .8 N 4 Covance 6329-223 3M T-6295.7 241 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 1 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LEFT ADRENAL -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 0.2858 0.0083 0.0045 STANDARD DEV: 765.9 0.0195 0.0012 0.0002 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 0.2933 0.0103 0.0052 STANDARD DEV: 304.9 0.0650 0.0016 0.0014 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 0.3105 0.0087 0.0051 STANDARD DEV: 524.0 0.0367 0.0015 0.0008 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 0.3815 0.0132 0.0063 STANDARD DEV: 723.4 0.0508 0.0033 0.0010 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 0.2692 0.0084 0.0043 STANDARD DEV: 199.8 0.0298 0.0006 0.0003 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 0.3400 0.0122 0.0058 STANDARD DEV: 335.9 0.0589 0.0012 0.0010 --------------------------------------------------------------- --------------------------------------------------------------- 242 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 2 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LEFT ADRENAL -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 0.3665 0.0120* 0.0055 STANDARD DEV: 1120.8 0.1237 0.0003 0.0012 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 0.3468 0.0134 0.0061 STANDARD DEV: 403.1 0.0265 0.0029 0.0004 --------------------------------------------------------------- 243 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 3 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RIGHT ADRENAL -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 0.2093 0.0059 0.0033 STANDARD DEV: 765.9 0.0503 0.0011 0.0008 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 0.2178 0.0076 0.0039 STANDARD DEV: 304.9 0.0772 0.0021 0.0016 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 0.2240 0.0063 0.0036 STANDARD DEV: 524.0 0.0243 0.0012 0.0005 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 0.2768 0.0095 0.0046 STANDARD DEV: 723.4 0.0356 0.0020 0.0005 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 0.2135 0.0067 0.0033 STANDARD DEV: 199.8 0.0484 0.0014 0.0006 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 0.2425 0.0088 0.0042 STANDARD DEV: 335.9 0.0377 0.0008 0.0006 --------------------------------------------------------------- --------------------------------------------------------------- 244 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 4 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RIGHT ADRENAL -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 0.2725 0.0090 0.0041 STANDARD DEV: 1120.8 0.0686 0.0011 0.0006 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 0.2535 0.0098 0.0044 STANDARD DEV: 403.1 0.0306 0.0025 0.0004 --------------------------------------------------------------- 245 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 5 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL BRAIN -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 63.1425 1.8330 1.0000 STANDARD DEV: 765.9 1.1363 0.3051 0.0000 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 56.6408 2.0307 1.0000 STANDARD DEV: 304.9 4.1710 0.3056 0.0000 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 61.7943 1.7415 1.0000 STANDARD DEV: 524.0 5.5692 0.3701 0.0000 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 60.6083 2.1053 1.0000 STANDARD DEV: 723.4 2.6726 0.4471 0.0000 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 63.3520 1.9873 1.0000 STANDARD DEV: 199.8 5.3720 0.1406 0.0000 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 58.3910 2.1321 1.0000 STANDARD DEV: 335.9 3.2163 0.2735 0.0000 --------------------------------------------------------------- --------------------------------------------------------------- 246 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 6 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL BRAIN -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 66.2635 2.2566 1.0000 STANDARD DEV: 1120.8 7.8154 0.5678 0.0000 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 57.0957 2.1883 1.0000 STANDARD DEV: 403.1 2.2179 0.3459 0.0000 --------------------------------------------------------------- 247 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 7 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF EPIDIDYMIS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 1.1407 0.0314 0.0180 STANDARD DEV: 765.9 0.5031 0.0076 0.0076 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2821.3 STANDARD DEV: 304.9 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 1.4208 0.0371 0.0243 STANDARD DEV: 524.0 0.9897 0.0196 0.0197 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2988.8 STANDARD DEV: 723.4 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 0.9760 0.0306 0.0155 STANDARD DEV: 199.8 0.0910 0.0027 0.0025 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2768.8 STANDARD DEV: 335.9 --------------------------------------------------------------- --------------------------------------------------------------- 248 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 8 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF EPIDIDYMIS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 1.3095 0.0387 0.0189 STANDARD DEV: 1120.8 1.0812 0.0210 0.0141 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 MEAN: 2653.8 STANDARD DEV: 403.1 --------------------------------------------------------------- 249 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 9 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT EPIDIDYMIS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 1.2160 0.0340 0.0192 STANDARD DEV: 765.9 0.4066 0.0063 0.0061 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2821.3 STANDARD DEV: 304.9 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 1.3563 0.0353 0.0232 STANDARD DEV: 524.0 0.9663 0.0191 0.0192 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2988.8 STANDARD DEV: 723.4 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 1.0213 0.0322 0.0163 STANDARD DEV: 199.8 0.0786 0.0039 0.0025 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2768.8 STANDARD DEV: 335.9 --------------------------------------------------------------- --------------------------------------------------------------- 250 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 10 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT EPIDIDYMIS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 1.3805 0.0396 0.0198 STANDARD DEV: 1120.8 1.3371 0.0290 0.0178 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 MEAN: 2653.8 STANDARD DEV: 403.1 --------------------------------------------------------------- 251 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 11 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF KIDNEY -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 6.2305 0.1780 0.0985 STANDARD DEV: 765.9 0.8729 0.0147 0.0120 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 5.5023 0.1943 0.0978 STANDARD DEV: 304.9 0.9665 0.0191 0.0214 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 6.6015 0.1838 0.1078 STANDARD DEV: 524.0 0.4812 0.0231 0.0163 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 5.8693 0.1993 0.0972 STANDARD DEV: 723.4 0.9019 0.0191 0.0166 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 5.8875 0.1844 0.0936 STANDARD DEV: 199.8 0.6683 0.0157 0.0150 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 5.5955 0.2033 0.0960 STANDARD DEV: 335.9 0.4375 0.0174 0.0090 --------------------------------------------------------------- --------------------------------------------------------------- 252 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 12 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF KIDNEY -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 5.5310 0.1837 0.0828 STANDARD DEV: 1120.8 1.3916 0.0217 0.0112 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 5.7638 0.2190 0.1007 STANDARD DEV: 403.1 0.9586 0.0364 0.0138 --------------------------------------------------------------- 253 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 13 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT KIDNEY -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 6.0052 0.1712 0.0949 STANDARD DEV: 765.9 0.9353 0.0127 0.0130 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 5.2995 0.1876 0.0941 STANDARD DEV: 304.9 0.7814 0.0168 0.0173 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 6.7495 0.1875 0.1104 STANDARD DEV: 524.0 0.6929 0.0228 0.0206 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 5.7718 0.1966 0.0956 STANDARD DEV: 723.4 0.8467 0.0260 0.0163 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 5.7358 0.1795 0.0910 STANDARD DEV: 199.8 0.6730 0.0140 0.0131 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 5.4028 0.1965 0.0926 STANDARD DEV: 335.9 0.4663 0.0210 0.0067 --------------------------------------------------------------- --------------------------------------------------------------- 254 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 14 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT KIDNEY -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 5.4045 0.1801 0.0810 STANDARD DEV: 1120.8 1.2594 0.0247 0.0095 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 5.7878 0.2191 0.1011 STANDARD DEV: 403.1 1.1793 0.0375 0.0181 --------------------------------------------------------------- 255 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 15 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LIVER -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 54.9200 1.5733 0.8689 STANDARD DEV: 765.9 8.1496 0.2144 0.1203 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 51.0925 1.8015 0.9104 STANDARD DEV: 304.9 9.4330 0.1518 0.2199 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 62.0868 1.7413 1.0090 STANDARD DEV: 524.0 5.2757 0.3311 0.0994 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 56.8278 1.9074 0.9392 STANDARD DEV: 723.4 12.5811 0.0398 0.2089 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 57.3325 1.7955 0.9059 STANDARD DEV: 199.8 5.5102 0.0901 0.0581 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 57.0393 2.0747 0.9783 STANDARD DEV: 335.9 3.1240 0.1801 0.0629 --------------------------------------------------------------- --------------------------------------------------------------- 256 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 16 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LIVER -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 85.2815 2.7247* 1.2616 STANDARD DEV: 1120.8 38.3782 0.2548 0.4304 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 75.2997* 2.8466* 1.3189* STANDARD DEV: 403.1 13.3835 0.3447 0.2262 --------------------------------------------------------------- 257 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 17 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF OVARY -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 MEAN: 3540.0 STANDARD DEV: 765.9 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 0.1688 0.0059 0.0030 STANDARD DEV: 304.9 0.0679 0.0022 0.0013 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 MEAN: 3631.3 STANDARD DEV: 524.0 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 0.1723 0.0056 0.0028 STANDARD DEV: 723.4 0.0729 0.0011 0.0012 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 MEAN: 3190.0 STANDARD DEV: 199.8 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 0.1873 0.0067 0.0032 STANDARD DEV: 335.9 0.0847 0.0028 0.0015 --------------------------------------------------------------- --------------------------------------------------------------- 258 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 18 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF OVARY -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 MEAN: 3077.5 STANDARD DEV: 1120.8 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 0.1590 0.0063 0.0028 STANDARD DEV: 403.1 0.0563 0.0031 0.0009 --------------------------------------------------------------- 259 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 19 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT OVARY -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 MEAN: 3540.0 STANDARD DEV: 765.9 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 0.1423 0.0050 0.0025 STANDARD DEV: 304.9 0.0491 0.0012 0.0010 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 MEAN: 3631.3 STANDARD DEV: 524.0 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 0.1788 0.0061 0.0029 STANDARD DEV: 723.4 0.0453 0.0014 0.0007 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 MEAN: 3190.0 STANDARD DEV: 199.8 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 0.1367 0.0049 0.0024 STANDARD DEV: 335.9 0.0353 0.0010 0.0007 --------------------------------------------------------------- --------------------------------------------------------------- 260 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 20 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT OVARY -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 MEAN: 3077.5 STANDARD DEV: 1120.8 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 0.1498 0.0058 0.0026 STANDARD DEV: 403.1 0.0169 0.0015 0.0003 --------------------------------------------------------------- 261 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 21 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF TESTIS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 6.9795 0.1918 0.1100 STANDARD DEV: 765.9 3.7391 0.0803 0.0572 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2821.3 STANDARD DEV: 304.9 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 7.8848 0.2009 0.1369 STANDARD DEV: 524.0 7.4545 0.1587 0.1434 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2988.8 STANDARD DEV: 723.4 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 5.0977 0.1600 0.0814 STANDARD DEV: 199.8 0.6925 0.0215 0.0173 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2768.8 STANDARD DEV: 335.9 --------------------------------------------------------------- --------------------------------------------------------------- 262 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 22 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF TESTIS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 7.0340 0.1946 0.0998 STANDARD DEV: 1120.8 7.9238 0.1866 0.1078 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 MEAN: 2653.8 STANDARD DEV: 403.1 --------------------------------------------------------------- 263 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 23 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT TESTIS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 6.7453 0.1868 0.1064 STANDARD DEV: 765.9 3.3813 0.0764 0.0518 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2821.3 STANDARD DEV: 304.9 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 8.1230 0.2089 0.1403 STANDARD DEV: 524.0 7.2175 0.1504 0.1403 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2988.8 STANDARD DEV: 723.4 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 5.0045 0.1568 0.0798 STANDARD DEV: 199.8 0.7091 0.0194 0.0163 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 MEAN: 2768.8 STANDARD DEV: 335.9 --------------------------------------------------------------- --------------------------------------------------------------- 264 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 24 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT TESTIS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 6.9155 0.1906 0.0980 STANDARD DEV: 1120.8 7.8977 0.1872 0.1076 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 MEAN: 2653.8 STANDARD DEV: 403.1 --------------------------------------------------------------- 265 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 25 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL PANCREAS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 5.4570 0.1576 0.0863 STANDARD DEV: 765.9 0.8021 0.0319 0.0119 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 4.4270 0.1571 0.0787 STANDARD DEV: 304.9 0.4797 0.0097 0.0125 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 4.8133 0.1309 0.0799 STANDARD DEV: 524.0 1.3674 0.0234 0.0298 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 5.9108* 0.2030 0.0982 STANDARD DEV: 723.4 1.0351 0.0437 0.0216 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 4.3790 0.1365 0.0687 STANDARD DEV: 199.8 1.1403 0.0294 0.0138 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 4.6248 0.1678 0.0792 STANDARD DEV: 335.9 0.4099 0.0126 0.0059 --------------------------------------------------------------- --------------------------------------------------------------- 266 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 26 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL PANCREAS -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 4.1355 0.1341 0.0615 STANDARD DEV: 1120.8 1.5450 0.0014 0.0161 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 4.3725 0.1659 0.0768 STANDARD DEV: 403.1 0.4273 0.0119 0.0089 --------------------------------------------------------------- 267 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 27 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF THYROID/PARA -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 0.1675 0.0047 0.0026 STANDARD DEV: 765.9 0.0479 0.0004 0.0007 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 0.2567 0.0088 0.0047 STANDARD DEV: 304.9 0.1415 0.0037 0.0029 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 0.2750 0.0074 0.0046 STANDARD DEV: 524.0 0.1374 0.0028 0.0027 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 0.2138 0.0071 0.0035 STANDARD DEV: 723.4 0.0751 0.0013 0.0012 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 0.2075 0.0064 0.0032 STANDARD DEV: 199.8 0.0792 0.0022 0.0011 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 0.1542 0.0057 0.0027 STANDARD DEV: 335.9 0.0382 0.0018 0.0007 --------------------------------------------------------------- --------------------------------------------------------------- 268 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 28 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LF THYROID/PARA -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 0.2020 0.0063 0.0030 STANDARD DEV: 1120.8 0.1174 0.0015 0.0014 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 0.1872 0.0071 0.0033 STANDARD DEV: 403.1 0.0463 0.0017 0.0008 --------------------------------------------------------------- 269 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 29 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT THYROID/PARA -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3540.0 0.1690 0.0046 0.0027 STANDARD DEV: 765.9 0.0711 0.0009 0.0011 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F1 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2821.3 0.2455 0.0084 0.0044 STANDARD DEV: 304.9 0.1300 0.0034 0.0027 --------------------------------------------------------------- M2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3631.3 0.2632 0.0070 0.0045 STANDARD DEV: 524.0 0.1614 0.0035 0.0031 --------------------------------------------------------------- F2 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2988.8 0.2350 0.0078 0.0039 STANDARD DEV: 723.4 0.0815 0.0016 0.0013 --------------------------------------------------------------- M3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 3190.0 0.2575 0.0080 0.0040 STANDARD DEV: 199.8 0.1150 0.0032 0.0016 --------------------------------------------------------------- F3 ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2768.8 0.1332 0.0048 0.0023 STANDARD DEV: 335.9 0.0279 0.0007 0.0005 --------------------------------------------------------------- --------------------------------------------------------------- 270 TABLE 48 Summary of Organ Weight Data Terminal Sacrifice Covance 6329-223 3M T-6295.7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS PAGE: 30 ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL RT THYROID/PARA -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- M4 -------------------------------- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT GROUP (g) (g) (%) RATIO --------------------------------------------------------------- F4 ------------------------------- NUMBER IN GROUP: 2 2 2 2 MEAN: 3077.5 0.2360 0.0072 0.0034 STANDARD DEV: 1120.8 0.1556 0.0024 0.0019 --------------------------------------------------------------- ------------------------------- NUMBER IN GROUP: 4 4 4 4 MEAN: 2653.8 0.1945 0.0073 0.0034 STANDARD DEV: 403.1 0.0633 0.0019 0.0011 --------------------------------------------------------------- 271 TABLE 49 Incidence of Macroscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- ** TOP OF LIST ** GENERAL COMMENT (GC) ................................. NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 0 0 0 0 0 0 0 0 BONE MARROW SMEAR TAKEN EYES - DAVIDSONS NO MACROSCOPIC LESIONS ANIMAL OBESE 44424444 44424444 22301010 00000100 LUNG (LU) ............................................ NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 3 3 3 2 2 1 1 0 ADHESION(S) RED FOCUS(I)/AREA(S) DARK FOCUS(I)/AREA(S) LIGHT FOCUS(I)/AREA(S) 01102310 10000012 00000212 00000001 LIVER (LI) ........................................... NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 4 4 4 0 3 3 4 3 MOTTLED ADHESION(S) LIGHT FOCUS(I)/AREA(S) 00020001 00000100 00001000 SPLEEN (SP) .......................................... NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 3 3 4 2 4 4 3 4 LARGE ** CONTINUED ON NEXT PAGE ** 11000000 272 TABLE 49 Incidence of Macroscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- ** FROM PREVIOUS PAGE ** SPLEEN (SP) .......................................... NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 3 3 4 2 4 4 3 4 LIGHT FOCUS(I)/AREA(S) 00000010 LN, MESENTERIC (MS) .................................. NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 4 4 4 1 4 4 4 4 DIFFUSELY RED 00010000 ADRENAL, CORTEX (AC) ................................. NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 4 4 4 0 4 4 4 2 DIFFUSELY DARK 00020002 STOMACH, GL (ST) ..................................... NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 4 4 4 2 3 4 4 4 RED FOCUS(I)/AREA(S) 00001000 CECUM (CE) ........................................... NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 4 4 4 2 4 4 2 3 RED FOCUS(I)/AREA(S) DARK FOCUS(I)/AREA(S) 00000020 00000001 273 TABLE 49 Incidence of Macroscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- COLON (CO) ........................................... NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 4 4 4 2 4 4 4 3 DARK FOCUS(I)/AREA(S) 00000001 SKIN (SK) ............................................ NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 3 4 4 2 4 4 4 2 ABRASION(S)/ULCERATION(S) ALOPECIA-DIFFUSE ALOPECIA-FOCAL 10000000 00000001 00000001 TESTIS (TE) .......................................... NUMBER EXAMINED: 4 4 4 2 0 0 0 0 NOT REMARKABLE: 4 3 4 2 0 0 0 0 LARGE 01000000 ADIPOSE TISSUE (AT) .................................. NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 4 4 3 2 4 4 4 3 RAISED FOCUS(I)/AREA(S) ** END OF LIST ** 00100001 274 TABLE 50 Incidence of Macroscopic Observations Covance 6329-223 3M T-6295.7 Recovery Sacrifice PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=4;WEEKS=ALL DEATH=U;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: MALE FEMALE GROUP: -4- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 2 2 ------------------------------------------------------------------------ -=- -= ** TOP OF LIST ** GENERAL COMMENT (GC) ................................. NUMBER EXAMINED: 2 2 NOT REMARKABLE: 1 1 NO MACROSCOPIC LESIONS 11 LUNG (LU) ............................................ NUMBER EXAMINED: 2 2 NOT REMARKABLE: 1 2 ADHESION(S) 10 LIVER (LI) ........................................... NUMBER EXAMINED: 2 2 NOT REMARKABLE: 2 1 ADHESION(S) 01 CAVITY, THORACIC (TA) ................................ NUMBER EXAMINED: 2 2 NOT REMARKABLE: 1 2 NODULE(S) ** END OF LIST ** 10 275 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- ** TOP OF LIST ** BONE, FEMUR (FE) ..................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 0 0 0 0 3 0 0 3 --GROWTH PLATE OPEN 40021001 MARROW, FEMUR (FM) ................................... NUMBER EXAMINED: 1 0 0 0 2 0 0 1 NOT REMARKABLE: 1 0 0 0 2 0 0 1 MARROW, STERNUM (SE) ................................. NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 3 0 0 4 --HYPOCELLULAR, MARROW 00001000 BONE, STERNUM (SB) ................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 4 EYE (EY) ............................................. NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 4 BRAIN (BR) ........................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 2 0 0 0 1 0 0 1 --INFILTRATE, LYMPHOHISTIOCYTIC, PERIVASCULAR --INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR --INFLAMMATION, LYMPHOHISTIOCYTIC 00010000 20023002 00000001 276 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- KIDNEY (KD) .......................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 2 0 0 1 2 0 0 2 --INFILTRATE, LYMPHOHISTIOCYTIC --GLOMERULOSCLEROSIS --MINERALIZATION, CORTEX --MINERALIZATION, MEDULLA 20011000 10001000 00010000 00000002 LUNG (LU) ............................................ NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 0 0 0 2 2 0 0 2 --HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR --FIBROSIS, PLEURAL/SUBPLEURAL --FIBROSIS, INTERSTITIAL --INFILTRATE, MACROPHAGE, ALVEOLAR --HEMORRHAGE 40001001 00002000 00001000 00000001 00000001 HEART (HT) ........................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 4 LIVER (LI) ........................................... NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 0 1 3 0 0 0 1 0 --INFILTRATE, LYMPHOHISTIOCYTIC --GRANULOMA --HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR --HYPERTROPHY, HEPATOCELLULAR ** CONTINUED ON NEXT PAGE ** 43104433 10000000 00010003 00110001 277 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- ** FROM PREVIOUS PAGE ** LIVER (LI) ........................................... NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 0 1 3 0 0 0 1 0 --VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR --VACUOLATION, HEPATOCELLULAR --STASIS, BILE --DEGENERATION/NECROSIS, HEPATOCELLULAR 00010001 01001101 01000000 00000010 GALLBLADDER (GB) ..................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 3 0 0 1 3 0 0 2 --INFILTRATE, LYMPHOHISTIOCYTIC 10011002 SPLEEN (SP) .......................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 4 THYMUS (TH) .......................................... NUMBER EXAMINED: 4 4 4 2 4 4 4 4 NOT REMARKABLE: 3 1 1 0 4 0 0 1 --CYST --ATROPHY 01010112 12320443 LN, MESENTERIC (MS) .................................. NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 2 0 0 1 3 0 0 4 --HEMORRHAGE --INFILTRATE, MACROPHAGE, PIGMENTED 10010000 10001000 278 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- TRACHEA (TR) ......................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 1 0 0 0 2 0 0 0 --INFILTRATE, LYMPHOHISTIOCYTIC --INFLAMMATION, ACUTE 30022004 00010000 ESOPHAGUS (ES) ....................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 3 0 0 4 --INFILTRATE, LYMPHOHISTIOCYTIC 00001000 THYROID (TY) ......................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 3 0 0 1 --INFILTRATE, LYMPHOHISTIOCYTIC --CYST, ULTIMOBRANCHIAL 00001001 00000002 PARATHYROID (PT) ..................................... NUMBER EXAMINED: 4 0 0 2 3 0 0 4 NOT REMARKABLE: 3 0 0 2 3 0 0 4 --CYST 10000000 ADRENAL, CORTEX (AC) ................................. NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 2 0 0 2 3 0 0 3 --HYPERTROPHY, CORTICAL CELL --INFILTRATE, LYMPHOHISTIOCYTIC --PIGMENT 10001001 10000000 00000001 279 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- ADRENAL, MEDULLA (MA) ................................ NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 4 AORTA (AO) ........................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 3 --PROLIFERATION, INTIMAL 00000001 PITUITARY (PI) ....................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 4 SALIV GL, MANDIB (SG) ................................ NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 0 0 0 1 2 0 0 2 --INFILTRATE, LYMPHOHISTIOCYTIC 40012002 MUSCLE, SKELETAL (SM) ................................ NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 3 0 0 2 2 0 0 2 --INFILTRATE, LYMPHOHISTIOCYTIC --DEGENERATION --INFLAMMATION, GRANULOMATOUS --REGENERATION, MYOFIBER --PARASITES, CYST 10000001 00001000 00001000 00001000 00001001 280 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- SPINAL CORD (SC) ..................................... NUMBER EXAMINED: 4 0 0 2 4 4 4 4 NOT REMARKABLE: 4 0 0 2 3 1 0 2 --PIGMENT, NEURONAL 00001342 NERVE, SCIATIC (SN) .................................. NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 4 STOMACH, GL (ST) ..................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 4 DUODENUM (DU) ........................................ NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 3 0 0 2 2 0 0 1 --INFILTRATE, MACROPHAGE, PIGMENTED 10002003 PANCREAS (PA) ........................................ NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 3 0 0 2 4 0 0 4 --INFILTRATE, LYMPHOHISTIOCYTIC 10000000 JEJUNUM (JE) ......................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 3 0 0 0 1 0 0 1 --INFILTRATE, MACROPHAGE, PIGMENTED 10023003 281 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- ILEUM (IL) ........................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 2 0 0 1 1 0 0 2 --INFILTRATE, MACROPHAGE, PIGMENTED 20013002 CECUM (CE) ........................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 3 0 0 2 3 0 0 2 --INFILTRATE, MACROPHAGE, PIGMENTED --PARASITISM 10001001 00000001 COLON (CO) ........................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 2 0 0 2 4 0 0 3 --INFILTRATE, EOSINOPHILIC --PARASITISM, INTRAMUSCULAR 10000000 10000001 RECTUM (RE) .......................................... NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 4 0 0 2 4 0 0 4 SKIN (SK) ............................................ NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 3 0 0 2 4 0 0 2 --HYPERPLASIA, EPIDERMAL (ACANTHOSIS) --INFLAMMATION, CHRONIC-ACTIVE --ULCERATION --HAIR FOLLICLES, DECREASED 10000000 10000000 10000000 00000002 282 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 8 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- MAMMARY, FEMALE (MF) ................................. NUMBER EXAMINED: 0 0 0 0 4 0 0 4 NOT REMARKABLE: 0 0 0 0 2 0 0 4 --INFLAMMATION, ACUTE --INFILTRATE, LYMPHOHISTIOCYTIC 00001000 00001000 MAMMARY, MALE (MM) ................................... NUMBER EXAMINED: 2 0 0 1 0 0 0 0 NOT REMARKABLE: 2 0 0 1 0 0 0 0 URINARY BLADDER (UB) ................................. NUMBER EXAMINED: 4 0 0 2 4 0 0 4 NOT REMARKABLE: 3 0 0 2 1 0 0 3 --INFILTRATE, LYMPHOHISTIOCYTIC 10003001 UTERUS (UT) .......................................... NUMBER EXAMINED: 0 0 0 0 4 0 0 4 NOT REMARKABLE: 0 0 0 0 2 0 0 3 --AMYLOID 00002001 OVARY (OV) ........................................... NUMBER EXAMINED: 0 0 0 0 4 0 0 4 NOT REMARKABLE: 0 0 0 0 3 0 0 2 --MINERALIZATION --AMYLOID --ONE EXAMINED 00001001 00000001 00000001 283 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 9 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- VAGINA (VA) .......................................... NUMBER EXAMINED: 0 0 0 0 4 0 0 4 NOT REMARKABLE: 0 0 0 0 4 0 0 4 CERVIX (CV) .......................................... NUMBER EXAMINED: 0 0 0 0 4 0 0 4 NOT REMARKABLE: 0 0 0 0 4 0 0 4 PROSTATE (PR) ........................................ NUMBER EXAMINED: 4 0 0 2 0 0 0 0 NOT REMARKABLE: 2 0 0 0 0 0 0 0 --INFLAMMATION, LYMPHOHISTIOCYTIC 20020000 SEMINAL VESICLES (SV) ................................ NUMBER EXAMINED: 4 0 0 2 0 0 0 0 NOT REMARKABLE: 4 0 0 2 0 0 0 0 EPIDIDYMIDES (EP) .................................... NUMBER EXAMINED: 4 0 0 2 0 0 0 0 NOT REMARKABLE: 3 0 0 1 0 0 0 0 --HYPOSPERMIA 10010000 TESTIS (TE) .......................................... NUMBER EXAMINED: 4 0 0 2 0 0 0 0 NOT REMARKABLE: 3 0 0 1 0 0 0 0 --IMMATURE 10010000 284 TABLE 51 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 10 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: -------MALE------- ------FEMALE-----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 4 4 4 2 4 4 4 4 ------------------------------------------------------------------------ -=- -=- -=- -=- -=- -=- -=- -=- ADIPOSE TISSUE (AT) .................................. NUMBER EXAMINED: 0 0 0 0 0 0 0 1 NOT REMARKABLE: 0 0 0 0 0 0 0 0 --LYMPHOID TISSUE 00000001 CAUSE OF DEATH (CD) .................................. NUMBER EXAMINED: 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 LN, TRACHEOBRON (TB) ................................. NUMBER EXAMINED: 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 ** END OF LIST ** 285 TABLE 52 Incidence of Microscopic Observations Covance 6329-223 3M T-6295.7 Recovery Sacrifice PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=4;WEEKS=ALL DEATH=U;FIND=ALL;SUBSET=ALL --- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: MALE FEMALE GROUP: -4- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 2 2 ------------------------------------------------------------------------ -=- -=- ** TOP OF LIST ** LIVER, BIOPSYa (LI0) ................................... NUMBER EXAMINED: 2 2 NOT REMARKABLE: 1 2 --PIGMENT, HEPATOCELLULAR 10 LIVER (LI) ........................................... NUMBER EXAMINED: 2 2 NOT REMARKABLE: 0 0 --INFILTRATE, LYMPHOHISTIOCYTIC --PIGMENT, HEPATOCELLULAR --HYPERPLASIA, BILE DUCT --INFLAMMATION, EOSINOPHILIC, PERI-BILE DUCT --FIBROSIS, CAPSULAR 21 10 10 10 01 ** END OF LIST ** a The liver biopsy was taken during Week 57 of recovery. 286 APPENDIX 1 Protocol Deviations Protocol Protocol Amendment No. 1 Protocol Amendment No. 2 Protocol Amendment No. 3 Protocol Amendment No. 4 Covance 6329-223 3M T-6295.7 287 Protocol Deviations Covance 6329-223 3M T-6295.7 Protocol. Reserve (Archive) Samples. "These samples will be transferred to the Sponsor after completion of the in-life phase." Actual Procedure. These samples were shipped to the Sponsor after the dosing phase was competed, which was prior to the end of the in-life phase. Protocol. Dosing Procedures. Method of Administration. "Orally by gelatin capsules, daily (7 days/week) for at least 26 weeks." Actual Procedure. On Day 3, Animal Nos. I05520 (Group 1 male) and I05529 (Group 1 female) did not receive a dose administration due to bleeding and irritation in the throat. Dosing was discontinued for Animal No. I05530 (Group 1 female) from Days 10 through 14 due to a sore inside its mouth. Protocol. Observation of Animals. Clinical Observations. "Once weekly, each animal will be observed; abnormal findings or an indication that the animal was normal will be recorded." Actual Procedure. During the course of the study, several animals did not have a weekly observation of normal of abnormal recorded on various scheduled days. Protocol. Observation of Animals. Ophthalmic Examinations. Before initiation of treatment and before each scheduled sacrifice; the anterior portion of the eye, optic media, and ocular fundus will be examined using an indirect ophthalmoscope by a boardcertified ophthalmologist. Actual Procedure. An ophthalmic examination was completed during Week 52 instead of prior to the recovery sacrifice during Week 79. 288 Protocol Deviations (Continued) Covance 6329-223 3M T-6295.7 Protocol. Clinical Pathology. Frequency. Scheduled Collections. "Once before initiation of treatment; after at least 30, 60, 90, 150, and 180 days of treatment (before the daily dose); and after at least 30, 60, 90, 135, 180, 274, and 365 days of recovery" Actual Procedure. On Day 184, urine samples were collected for several animals; however, these samples were not required by the protocol and were discarded. Samples were collected on Days 273 and 363 of recovery. Protocol. Clinical Pathology. Tests. Hematology. Eleven hematological parameters were to be tested at all intervals. Actual Procedure. In addition to the required hematology tests at the pretreatment interval, mean platelet volume, red blood cell distribution width, platelet distribution width, and plateletcrit were also inadvertently tested for. Protocol. Blood Hormone Determination. Frequency. "Three times before initiation of treatment; after at least 30, 60, 90, and 180 days of treatment; and after at least 30, 60, 90, 135, 180, 274, and 365 days of recovery." Actual Procedure. Samples were collected on Days 273 and 363 of recovery. Protocol. Serum PFOS Level Determination. Method of Collection. "Animals will be fasted overnight; blood (approximately 2 mL) will be collected from a femoral vein without an anticoagulant." Actual Procedure. Animals were not fasted overnight for the scheduled collection on Day 197; however, animals were fasted the following night and collection was done on Day 198. 289 Protocol Deviations (Continued) Covance 6329-223 3M T-6295.7 Protocol. Urine and Feces PFOS Level Determination. Method of Collection. "Animals will not be fasted (except for the first day of recovery); urine (at least 2 mL) and feces (at least 5 g) will be collected overnight." Actual Procedure. The amount of urine collected was not documented at the time of each collection and therefore cannot be verified. Protocol. Additional Fecal Samples. "The samples will be collected in the early afternoon after pans are cleaned in the morning to ensure that they are no more than 6 hours old." Actual Procedure. On Day 160, some fecal samples were collected in the late morning rather than the early afternoon. Protocol. Interim Liver Biopsy Samples. "Kris J. Hansen or her alternate will be notified regarding the shipment of the samples." Actual Procedure. The phone call made to notify Kris J. Hansen prior to shipment of these samples was not documented and therefore cannot be verified. Protocol. Terminal Liver Biopsy Samples. "A sample of liver (approximately 1 g) will be collected by biopsy from all animals in Groups 3 during recovery (Week 79, within 1 day of the serum PFOS blood collection)." Actual Procedure. These samples were collected during Week 80, and were not collected within one day of the serum PFOS blood collection. Protocol. Postmortem Procedures. Cell Proliferation Evaluation. "After fixation, samples for proliferation cell nuclear antigen (PCNA) evaluation will be embedded in paraffin and shipped to:" 290 Protocol Deviations (Continued) Covance 6329-223 3M T-6295.7 Actual Procedure. PCNA analysis was not done for Animal No. I05509 (Group 4 male). Protocol. Termination. Postmortem Procedures. Additional Lung Tissue Samples. "At the terminal necropsy, a sample of lung (approximately 5 g) will be collected from an animal in the high-dose group. This sample will be weighed, flash-frozen in liquid nitrogen, and stored in a freezer, set to maintain -60 to -80-C, until shipped. This frozen sample, and a sample of lung (approximately 1 g, stored in formalin) from Animal No. I05509 (Group 4 male, died January 27, 1999) will be sent separately under appropriate conditions (ambient or packed on dry ice) to: Kris J. Hansen, PhD 3M E. T. & S. Bldg. 2-3E-09 935 Bush Avenue St. Paul, Minnesota 55106 Telephone: 651.778.6018 Facsimile: 651.778.6176 Kris J. Hansen or her alternate will be notified regarding the shipment of the samples." Actual Procedure. This procedure was inadvertently not done at the terminal sacrifice; thus no samples were available for shipment to Kris J. Hansen, PhD. Protocol. Termination. Postmortem Procedures. Tissue Preservation. "The following tissues (when present) from each animal will be preserved in 10% neutral-buffered formalin, unless otherwise specified, for possible future microscopic examination." 291 Protocol Deviations (Continued) Covance 6329-223 3M T-6295.7 Actual Procedure. Femoral bone marrow from Animal Nos. I05517, I05519, I05527 (Group 1 males), I05507, I05509, I05512 (Group 4 males), I05531, I05535 (Group 1 females), I05536, I05540, and I05551 (Group 4 females); mammary gland from Animal Nos. I05508, I05519 (Group 1 males), and I05512 (Group 4 male); and parathyroid from Animal No. I05544 (Group 1 female) were insufficient. These tissues, therefore, were not examined microscopically. Additionally, one ovary of a possible two was examined from Animal No. I05536 (Group 4 female). Missing tissues are listed with appropriate comments in the pathology data sheets for individual animals. Summary tables do not include them as having been examined. These deviations are not expected to have affected the results of the study. 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 PROTOCOL AMENDMENT NO. 2 Covance 6329-223 3M T-6295.7 26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys Sponsor: Study Monitor: Testing Facility: Study Director: 3M, St. Paul, Minnesota Andrew M. Seacat, PhD Covance Laboratories Inc., Madison, Wisconsin Peter J. Thomford, PhD This amendment modifies the following portions of the protocol. Effective February 19, 1999 1. Page 9, Observation of Animals, Clinical Observations, Paragraph 2, Sentence 2. To add an observation on the day of scheduled sacrifice, delete this sentence and replace with the following. Once weekly and on the day of scheduled sacrifice, each animal will be observed; abnormal findings or an indication that the animal is normal will be recorded. Effective June 11, 1999 2. Page 11, Blood Hormone Determination, Tests. To add free triiodothyronine (T3) and free thyroxin (T4) tests, delete the text in this section and replace with the following. Samples will be analyzed by Ani Lytics Inc. for cortisol, testosterone, estradiol, estrone, estriol, thyroid stimulating hormone, total and free triiodothyronine (T3), and total and free thyroxin (T4). 320 Covance 6329-223 3M T-6295.7 Protocol Amendment No. 2 Page 2 3. Page 16, Reports, Final Report, Statistical Evaluation. To add repeated measure statistical analysis of cholesterol and total and free triiodothyronine (T3), add the following to the end of the section. Cholesterol and total and free triiodothyronine (T3) will be analyzed by repeated measures analysis of covariance (ANCOVA) procedure with average pretreatment measurements for the parameters as covariates. Treatment effects under ANOVA or ANCOVA procedures will be evaluated at p = 0.05 level. All post-hoc control-versus-treated-group mean comparisons (including values during recovery) will be conducted using Dunnett's many-on-one t procedure. Analyses will be carried out with SAS procedure PROC MIXED or BMDP, or both. Effective August 24, 1999 4. Page 7, Group Designations and Dosage Levels, Footnote d. To reflect the decision of the Sponsor and the Study Director to extend the length of recovery, delete the text in this footnote and replace with the following. d Two animals in Groups 1, 3, and 4 designated as recovery animals will be treated for at least 26 weeks, then treatment will be discontinued, and the animals will be observed for reversibility, persistence, or delayed occurrence of toxic effects for at least 52 weeks posttreatment. 5. Page 9, Clinical Pathology, Frequency, Scheduled Collections. To reflect the decision of the Sponsor and the Study Director to extend the length of recovery, delete the text in this section and replace with the following. Once before initiation of treatment; after at least 30, 60, 90, 150, and 180 days of treatment (before the daily dose); and after at least 30, 60, 90, 135, 180, 274, and 365 days of recovery 6. Page 10, Blood Hormone Determination, Frequency. To reflect the decision of the Sponsor and the Study Director to extend the length of recovery, delete the text in this section and replace with the following. Three times before initiation of treatment; after at least 30, 60, 90, and 180 days of treatment; and after at least 30, 60, 90, 135, 180, 274, and 365 days of recovery 321 Covance 6329-223 3M T-6295.7 Protocol Amendment No. 2 Page 3 7. Page 11, Serum PFOS Level Determination, Frequency. To reflect the decision of the Sponsor and the Study Director to extend the length of recovery, delete the text in this section and replace with the following. Before initiation of treatment; during Weeks 1 (Day 7), 2, 4, 6, 8, 12, 16, 20, 24, 26, and 27 (Day 183) during treatment; and during Weeks 27 (Days 184, 185, and 187), 28 (Day 190), 29 (Day 197), 30 (Day 204), 31 (Day 211), 35, 39, 43, 47, 51, 53, 57, 61, 65, 69, 73, 77, and 79 Effective August 24, 1999, and January 12 and 21, 2000 8. Page 13, Termination, Scheduled Sacrifices. To reflect the decision of the Sponsor and the Study Director to extend the length of recovery (effective August 24, 1999), to reflect the decision of the Sponsor to cancel the recovery necropsy (effective January 12, 2000), and to subsequently clarify the requirement (effective January 21, 2000), delete the text in this section and replace with the following. After at least 26 weeks of treatment, up to four animals/sex/group will be fasted overnight, then anesthetized with ketamine and xylazine, weighed, exsanguinated, and necropsied. After at least 26 weeks of treatment and at least 52 weeks without treatment, the remaining animals will be removed from the study as follows. Two animals/sex in Group 1 will be returned to the Covance stock. Two animals/sex in Group 3 will be transferred to a subsequent study (Covance 6329-268). Two animals/sex in Group 4 will be fasted overnight, then anesthetized with ketamine and xylazine, weighed, exsanguinated, and necropsied. Effective August 24 and September 22, 1999 9. Page 12, Additional Fecal Samples. At the request of the Sponsor to collect liver samples by biopsy (effective August 24, 1999) and to modify the procedures (effective September 22, 1999), add the following after this section. 322 Covance 6329-223 3M T-6295.7 Protocol Amendment No. 2 Page 4 Interim Liver Biopsy Samples A sample of liver (approximately 1 to 2 g) will be collected by biopsy from animals in Group 4 only during recovery (Week 57, within 1 day of the serum PFOS blood collection). This sample will be divided into four portions as follows. One subsample will be preserved in 10% neutral-buffered formalin, embedded in paraffin, sectioned, stained with hematoxylin and eosin (duplicate slides will be prepared), and examined microscopically. The second subsample will be flash-frozen in liquid nitrogen, and stored in a freezer, set to maintain -60 to -80-C, until shipped for analysis to: Kris J. Hansen, PhD 3M E. T. & S. Bldg. 2-3E-09 935 Bush Avenue St. Paul, Minnesota 55106 Telephone No.: 651.778.6018 Facsimile No.: 651.778.6176 Kris J. Hansen or her alternate will be notified regarding the shipment of the samples. Results will be provided for inclusion in the final report. The third subsample will be processed to block stage for electron microscopic evaluation. The tissue blocks and a hematoxylin and eosin-stained slide for light microscopy will be transferred to: Sharon Ambrose Division Director Pathology Associates International 4915 D. Prospectus Drive Durham, North Carolina 27713 Telephone No.: 919.544.5257 Facsimile No.: 919.544.3218 Tissues will be processed and evaluated by electron microscopy by Pathology Associates International (PAI). A report will be provided by PAI for inclusion in the final report. Sharon Ambrose or her alternate will be notified regarding the shipment of the samples. 323 Covance 6329-223 3M T-6295.7 Protocol Amendment No. 2 Page 5 The fourth subsample will be flash-frozen in liquid nitrogen and stored in a freezer, set to maintain -60 to -80-C, and transferred to the Sponsor for possible future analysis. Effective January 12 and 21, 2000 10. Page 12, Interim Liver Biopsy Samples. At the request of the Sponsor to collect liver samples by biopsy, then terminate the study and transfer the animals to a subsequent study (effective January 12, 2000) and to modify the requirement (effective January 21, 2000), add the following after this section. Terminal Liver Biopsy Samples A sample of liver (approximately 1 g) will be collected by biopsy from all animals in Groups 3 during recovery (Week 79, within 1 day of the serum PFOS blood collection). This sample will be flash-frozen in liquid nitrogen and stored in a freezer, set to maintain -60 to -80-C, until shipped for analysis to: Kris J. Hansen, PhD 3M E. T. & S. Bldg. 2-3E-09 935 Bush Avenue St. Paul, Minnesota 55106 Telephone No.: 651.778.6018 Facsimile No.: 651.778.6176 Kris J. Hansen or her alternate will be notified regarding the shipment of the samples. Results will be provided for inclusion in the final report. Effective January 21, 2000 11. Page 12, Additional Serum Collection. To reflect the decision of the Sponsor to analyze additional serum samples for specified thyroid hormones, add following to the end of this section. An aliquot (0.8 ml) of the additional serum collection samples collected from all animals from Groups 1, 2, 3 and 4 sacrificed at the terminal necropsy will be sent on dry ice by the Sponsor to Dr. Saroj Das, Ani Lytics, for free T3, free T4, total T3, and total T4 determinations. 324 Covance 6329-223 3M T-6295.7 Protocol Amendment No. 2 Page 6 12. Page 12, Urine and Feces PFOS Level Determination, Frequency. To reflect the decision of the Sponsor to collect a 24-hour urine and fecal sample after one year of recovery, delete the text in this section and replace with the following. On the first day of recovery and after at least 6, 30, 90, 135, and 180 days of recovery. In addition, a 24-hour sample of urine and feces will be collected before the completion of 52 weeks of recovery. 13. Page 16, Postmortem Procedures, Histopathology. To define the postmortem procedures for recovery animals in the high-dose group, add the following after this section. Postmortem Procedures for Recovery Animals in the High-Dose Group At necropsy of the recovery animals in the high-dose group, procedures (including organ weights and collection of tissues for histopathological examination) described previously are not required. The following procedures will be done. Necropsy The necropsy will include examination of: all orifices cranial cavity external surface of the brain; the external surface of the spinal cord and cut surfaces of the brain and spinal cord will be examined when tissue trimming is performed cervical tissues and organs thoracic, abdominal, and pelvic cavities and viscera external surface of the body nasal cavity and paranasal sinuses Liver Samples A sample of liver (approximately 1 to 2 g) will be collected. This sample will be divided into three portions as follows. One subsample will be preserved in 10% neutral-buffered formalin, embedded in paraffin, sectioned, stained with hematoxylin and eosin (duplicate slides will be prepared), and examined microscopically. The second subsample will be flash-frozen in liquid nitrogen and stored in a freezer, set to maintain -60 to -80-C, until shipped for analysis to: 325 Covance 6329-223 3M T-6295.7 Protocol Amendment No. 2 Page 7 Kris J. Hansen, PhD 3M E. T. & S. Bldg. 2-3E-09 935 Bush Avenue St. Paul, Minnesota 55106 Telephone No.: 651.778.6018 Facsimile No.: 651.778.6176 Kris J. Hansen or her alternate will be notified regarding the shipment of the samples. Results will be provided for inclusion in the final report. The third subsample will be processed to block stage for electron microscopic evaluation. The tissue blocks and a hematoxylin and eosin-stained slide for light microscopy will be transferred to: Sharon Ambrose Division Director Pathology Associates International 4915 D. Prospectus Drive Durham, North Carolina 27713 Telephone No.: 919.544.5257 Facsimile No.: 919.544.3218 Tissues will be processed and evaluated by electron microscopy by Pathology Associates International (PAI). A report will be provided by PAI for inclusion in the final report. Sharon Ambrose or her alternate will be notified regarding the shipment of the samples. Additional Tissue and Serum Samples Samples of lung, kidney, spleen, thyroid, brain, abdominal fat, heart, bile, (approximately 3 g each), and serum (as much as possible) will be collected. These samples will be flash-frozen in liquid nitrogen and stored in a freezer, set to maintain -60 to -80-C, until shipped for possible future analysis to: Kris J. Hansen, PhD 3M E. T. & S. Bldg. 2-3E-09 935 Bush Avenue St. Paul, Minnesota 55106 Telephone No.: 651.778.6018 Facsimile No.: 651.778.6176 326 Covance 6329-223 3M T-6295.7 Protocol Amendment No. 2 Page 8 Kris J. Hansen or her alternate will be notified regarding the shipment of the samples. Effective February 11 and 15, 2000 14. Page 3, Proposed Study Timetable. To change proposed dates for in-life termination (effective February 11, 2000) and the audited draft report (effective February 15, 2000), delete the text in this section and replace with the following. Experimental Start Date: August 26, 1998 In-life Start Date: August 26, 1998 In-life Termination Date: March 7, 2000 Unaudited Draft Interim Report Date: May 11, 1999 Audited Draft Report Date: May 29, 2000 Experimental Termination Date: To be determined AMENDMENT APPROVAL 327 328 329 330 331 332 333 334 335 APPENDIX 2 Individual Animal Fate Data Individual Clinical Observations Individual Ophthalmic Observations Covance 6329-223 3M T-6295.7 336 APPENDIX 2 Individual Animal Fate Data Covance 6329-223 3M T-6295.7 PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER -----I05508 I05517 I05519 I05520 I05526 I05527 I05514 I05515 I05516 I05521 I05505 I05510 I05518 I05523 I05524 I05528 I05506 I05507 I05509 I05511 I05512 I05522 I05529 I05530 I05531 I05535 I05544 I05549 I05537 I05541 I05547 I05550 I05532 I05538 DOSE GROUP ----- 1 1 1 1 1 1 2 2 2 2 3 3 3 3 3 3 4 4 4 4 4 4 1 1 1 1 1 1 2 2 2 2 3 3 SEX ------ MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE DEATH CODE ----- T T T O O T T T T T 6 T T 6 T T M T D U T U P T T T T P T T T T T T TYPE OF DEATH ----------SCHEDULED SCHEDULED SCHEDULED UNSCHEDULED UNSCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED UNSCHEDULED SCHEDULED UNSCHEDULED SCHEDULED SCHEDULED SCHEDULED UNSCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED UNSCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED DESCRIPTION OF DEATH ------------------------TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE UNSCHEDULED DEATH UNSCHEDULED DEATH TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE SIXTH INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE SIXTH INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE UNSCHEDULED DEATH TERMINAL SACRIFICE UNSCHEDULED DEATH FIRST POST-RECOV SAC TERMINAL SACRIFICE FIRST POST-RECOV SAC UNSCHEDULED DEATH TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE UNSCHEDULED DEATH TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE DATE OF DEATH -------02/25/99 02/25/99 02/25/99 02/25/00 02/25/00 02/25/99 02/25/99 02/26/99 02/26/99 02/26/99 03/08/00 02/26/99 02/26/99 03/08/00 02/26/99 02/26/99 02/20/99 02/25/99 01/27/99 02/25/00 02/25/99 02/25/00 02/25/00 02/25/99 02/26/99 02/26/99 02/25/99 02/25/00 02/25/99 02/26/99 02/26/99 02/26/99 02/25/99 02/25/99 DAY OF STUDY ------184 184 184 549 549 184 184 185 185 185 561 185 185 561 185 185 179 184 155 549 184 549 549 184 185 185 184 549 184 185 185 185 184 184 WEEK OF STUDY ------27 27 27 79 79 27 27 27 27 27 81 27 27 81 27 27 26 27 23 79 27 79 79 27 27 27 27 79 27 27 27 27 27 27 337 APPENDIX 2 Individual Animal Fate Data Covance 6329-223 3M T-6295.7 PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER -----I05539 I05545 I05548 I05552 I05533 I05534 I05536 I05540 I05542 I05551 DOSE GROUP ----- 3 3 3 3 4 4 4 4 4 4 SEX -----FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE DEATH CODE ----- 6 T T 6 U T T T U T TYPE OF DEATH ----------SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED DESCRIPTION OF DEATH ------------------------SIXTH INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE SIXTH INTERIM SACRIFICE FIRST POST-RECOV SAC TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST POST-RECOV SAC TERMINAL SACRIFICE DATE OF DEATH -------03/08/00 02/25/99 02/25/99 03/08/00 02/25/00 02/26/99 02/25/99 02/26/99 02/25/00 02/26/99 DAY OF STUDY ------561 184 184 561 549 185 184 185 549 185 WEEK OF STUDY ------81 27 27 81 79 27 27 27 79 27 338 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05508 T 27 NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 184 P - - P 339 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05517 T 27 NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 184 P - - P QUALITATIVE FOOD CONSUMPTION LOW 102 P - - - 340 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05517 T 27 QUALITATIVE FOOD CONSUMPTION LOW 141 P - - - 176 P - - - 177 P - - - 179 P - - - I05519 T 27 NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 341 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05519 T 27 NORMAL NO REMARKABLE OBSERVATIONS 176 P - - - 183 P - - - 184 P - - P I05520 O 79 DISCHARGE VOMITUS CONTAINING FOOD 141 P - - - EXCRETION LIQUID FECES NON-FORMED FECES 29 - - P - 29 P - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 342 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05520 O 79 NORMAL NO REMARKABLE OBSERVATIONS 134 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - QUALITATIVE FOOD CONSUMPTION LOW 122 P - - - I05526 O 79 EXCRETION NON-FORMED FECES 179 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 343 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05526 O 79 NORMAL NO REMARKABLE OBSERVATIONS 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - I05527 T 27 DISCHARGE UNKNOWN SOURCE FOUND IN PAN RED IN COLOR 144 P - - - EXCRETION NON-FORMED FECES 2 P - - - SKIN & PELAGE BROKEN SKIN HAND-LEFT TAIL 37 P - - - 38 P - P - 39 P - P - 40 P - - - 43 P - - - 168 - - P - 169 P - - - 170 - - P - 176 P - - - 177 - - P - 344 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05527 T 27 SKIN & PELAGE BROKEN SKIN TAIL 178 P - P - 179 P - - - 180 P - - - 181 - - P - 183 P - - - 184 P - - P TAIL-DISTAL 145 - - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 345 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 8 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05527 T 27 NORMAL NO REMARKABLE OBSERVATIONS 155 P - - - 162 P - - - QUALITATIVE FOOD CONSUMPTION LOW 43 P - - - 346 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 9 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05514 T 27 EXCRETION LIQUID FECES NON-FORMED FECES 91 P - - - 105 - - P - 132 - - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 347 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 10 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05514 T 27 NORMAL NO REMARKABLE OBSERVATIONS 183 P - - - 184 P - - P QUALITATIVE FOOD CONSUMPTION LOW 102 P - - - 179 P - - - I05515 T 27 EXCRETION NON-FORMED FECES 69 - - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 348 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 11 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05515 T 27 NORMAL NO REMARKABLE OBSERVATIONS 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 141 P - - - 162 P - - - I05516 T 27 DISCHARGE VOMITUS CONTAINING FOOD PARTIAL CAPSULE 179 P - - - 85 - - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 349 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 12 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05516 T 27 NORMAL NO REMARKABLE OBSERVATIONS 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 179 P - - - I05521 T 27 SKIN & PELAGE BROKEN SKIN PERI-ORBITAL-RIGHT 20 P - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 350 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 13 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05521 T 27 NORMAL NO REMARKABLE OBSERVATIONS 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 P - - P 351 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 14 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05505 6 81 DISCHARGE VOMITUS CONTAINING FOOD 141 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 352 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 15 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05505 6 81 QUALITATIVE FOOD CONSUMPTION LOW 80 P - - - 141 P - - - 180 P - - - I05510 T 27 EXCRETION DISCOLORED URINE RED IN COLOR 97 - - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 134 P - - - 141 P - - - 353 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 16 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05510 T 27 NORMAL NO REMARKABLE OBSERVATIONS 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 67 P - - - 73 P - - - 109 P - - - 127 P - - - 141 P - - - 142 P - - - 148 P - - - 154 P - - - 180 P - - - 183 P - - - I05518 T 27 DISCHARGE VOMITUS CONTAINING FOOD 179 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 354 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 17 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05518 T 27 NORMAL NO REMARKABLE OBSERVATIONS 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 141 P - - - 179 P - - - 355 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 18 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05523 6 81 SKIN & PELAGE BROKEN SKIN TAIL 149 - - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 356 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 19 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05523 6 81 QUALITATIVE FOOD CONSUMPTION LOW 6 P - - - 141 P - - - 179 P - - - I05524 T 27 DISCHARGE VOMITUS CONTAINING FOOD 141 P - - - EXCRETION NON-FORMED FECES 179 P - - - 180 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 357 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 20 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05524 T 27 NORMAL NO REMARKABLE OBSERVATIONS 120 P - - - 127 P - - - 134 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 43 P - - - 65 P - - - 141 P - - - 179 P - - - 180 P - - - I05528 T 27 NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 85 P - - - 358 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 21 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05528 T 27 NORMAL NO REMARKABLE OBSERVATIONS 92 P - - - 99 P - - - 106 P - - - 120 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 78 P - - - 113 P - - - 116 P - - - 127 P - - - 134 P - - - 162 P - - - 176 P - - - 179 P - - - 359 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 22 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05506 M 26 BEHAVIOR ATAXIC <UNSPECIFIED> HYPOACTIVE <UNSPECIFIED> 179 - P - P 179 - P - P DISCHARGE EXCESSIVE SALIVATION 179 - P - - RESPIRATION LABORED 179 - P - P NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 360 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 23 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05506 M 26 NORMAL NO REMARKABLE OBSERVATIONS 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - QUALITATIVE FOOD CONSUMPTION LOW 3 P - - - 141 P - - - 178 P - - - 179 P - - - I05507 T 27 DISCHARGE VOMITUS PARTIAL CAPSULE 11 - - P - 111 - - P - 178 - - P - SKIN & PELAGE BROKEN SKIN DIGIT(S)-FRONT-LEFT 97 - - P - 98 P - P - 99 P - P - 100 P - - - 101 - - P - 102 P - - - 104 P - P - 106 P - P - 107 P - P - 361 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 24 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05507 T 27 SKIN & PELAGE BROKEN SKIN DIGIT(S)-FRONT-LEFT 108 P - - - 111 - - P - 112 P - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 362 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 25 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05507 T 27 NORMAL NO REMARKABLE OBSERVATIONS 184 P - - P QUALITATIVE FOOD CONSUMPTION LOW 141 P - - - I05509 D 23 APPEARANCE APPEARS DEHYDRATED OTHER 155 - P - P 155 - - - PC BEHAVIOR HYPOACTIVE <UNSPECIFIED> 155 - P - P EXCRETION DISCOLORED FECES BLACK IN COLOR FEW FECES LIQUID FECES MUCOID FECES NO FECES 155 P - - - 152 P - - - 155 P - - - 155 P - - - 155 P - - - 154 P - - - EYES CONSTRICTED PUPIL EYES 154 - - P - RESPIRATION LABORED 155 - P - P 363 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 26 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05509 D 23 SKIN & PELAGE COLD TO TOUCH BODY-ENTIRE PALE SKIN GUMS 155 - P - P 154 - - P - 155 - P - P NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 364 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05509 D 23 QUALITATIVE FOOD CONSUMPTION LOW 141 P - - - 152 P - - - 154 P - - - 155 P - - - I05511 U 79 DISCHARGE VOMITUS CONTAINING FOOD PARTIAL CAPSULE 100 P - - - 155 - - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 365 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 28 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05511 U 79 NORMAL NO REMARKABLE OBSERVATIONS 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - QUALITATIVE FOOD CONSUMPTION LOW 57 P - - - 60 P - - - 100 P - - - 102 P - - - 141 P - - - 145 P - - - 148 P - - - 154 P - - - 155 P - - - 170 P - - - 171 P - - - 172 P - - - 173 P - - - 174 P - - - 175 P - - - 176 P - - - 177 P - - - 179 P - - - 180 P - - - 366 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 29 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05512 T 27 DISCHARGE VOMITUS PARTIAL CAPSULE 32 - - P - 37 - - P - EXCRETION FEW FECES NO FECES NON-FORMED FECES 100 P - - - 102 P - - - 105 P - - - 106 P - - - 110 P - - - 125 P - - - 126 P - - - 127 P - - - 128 P - - - 129 P - - - 130 P - - - 133 P - - - 134 P - - - 155 P - - - 156 P - - - 157 P - - - 158 P - - - 159 P - - - 161 P - - - 181 P - - - 183 P - - - 184 P - - - 99 P - - - 131 P - - - 132 P - - - 130 P - - - 367 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 30 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05512 T 27 EXCRETION NON-FORMED FECES 133 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 113 P - - - 120 P - - - 141 P - - - 148 P - - - 162 P - - - 169 P - - - 176 P - - - 184 - - - P QUALITATIVE FOOD CONSUMPTION LOW 17 P - - - 98 P - - - 99 P - - - 100 P - - - 368 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 31 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05512 T 27 QUALITATIVE FOOD CONSUMPTION LOW 102 P - - - 105 P - - - 110 P - - - 116 P - - - 125 P - - - 126 P - - - 127 P - - - 128 P - - - 129 P - - - 130 P - - - 131 P - - - 132 P - - - 133 P - - - 134 P - - - 155 P - - - 156 P - - - 157 P - - - 158 P - - - 159 P - - - 160 P - - - 161 P - - - 162 P - - - 164 P - - - 168 P - - - 174 P - - - 175 P - - - 176 P - - - 178 P - - - 179 P - - - 180 P - - - 181 P - - - 369 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 32 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05512 T 27 QUALITATIVE FOOD CONSUMPTION LOW 183 P - - - I05522 U 79 EXCRETION MUCOID FECES 179 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 370 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 33 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05522 U 79 NORMAL NO REMARKABLE OBSERVATIONS 176 P - - - 183 P - - - QUALITATIVE FOOD CONSUMPTION LOW 102 P - - - 180 P - - - 371 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 34 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY STUDY KEYWORD ANIMAL GROUP DAY WK QUALIFIER FREE-TEXT COMMENT ------------------------------------------------------------------------------------------------------------------------------------ I05509 M4 155 23 APPEARANCE OTHER AFTER DOSING ANIMAL BECAME RECUMBENT. VET WAS CALLED. ANIMAL DIED PRIOR TO VET EXAM. 372 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 35 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05529 P 79 APPEARANCE APPEARS DEHYDRATED 5 - - P - 6 P - - - 7 P - - - BEHAVIOR HYPOACTIVE <UNSPECIFIED> 6 - - P - 7 P - - - 8 P - P - DISCHARGE NASAL CLEAR ORAL CLOUDY EXCESSIVE SALIVATION 5 - - P - 6 P - P - 7 P - - - 8 P - P - 9 P - - - 6 - - P - 7 P - - - 8 P - - - 5 - - P - 6 P - P - 7 P - - - 8 P - - - EXCRETION LIQUID FECES 29 P - - - 30 P - - - 38 P - P - 39 P - - - 373 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 36 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 EXCRETION LIQUID FECES 40 - - P - 41 P - - - 42 P - P - 43 P - - - 44 P - - - 65 - - P - 66 P - - - 67 P - - - 68 P - - - 69 P - - - 70 P - - - 99 - - P - 100 P - P - 101 P - - - 102 P - - - 115 - - P - NON-FORMED FECES 71 P - - - 73 P - - - 77 P - - - 103 P - - - 115 P - - - SKIN & PELAGE ALOPECIA FEET 105 P - P - 106 P - P - 107 P - P - 108 P - P - 109 P - P - 110 P - P - 111 P - P - 374 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 SKIN & PELAGE ALOPECIA FEET 112 P - P - 113 P - P - 114 P - P - 115 P - P - 117 P - P - 118 P - P - 119 P - P - 120 P - P - 121 P - P - 122 - - P - 124 - - P - 125 P - P - 126 P - P - 127 P - P - 128 P - P - 129 - - P - 130 P - P - 131 P - P - 132 P - P - 133 P - P - 134 P - P - 135 P - P - 136 P - P - 137 P - P - 138 P - - - 139 P - P - 140 P - P - 142 P - P - 143 P - P - 146 P - P - 375 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 38 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 SKIN & PELAGE ALOPECIA FEET 147 P - P - 148 P - - - 149 P - P - 150 P - P - 151 P - P - 152 P - P - 153 P - P - 154 P - - - 155 P - - - 156 P - - - 157 P - P - 158 - - P - 162 P - P - 163 P - P - 164 P - P - 165 P - P - 166 P - P - 167 P - P - 168 P - P - 169 P - P - 170 P - P - 171 P - P - 172 P - P - 173 P - P - 174 P - P - 175 P - P - 176 P - P - 177 P - P - 178 P - P - 179 P - P - 376 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 39 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 SKIN & PELAGE ALOPECIA FEET 180 P - P - 181 - - P - 182 P - P - 183 P - P - 184 P - - - 185 P - - - LIMBS-HIND 92 - - P - 93 - - P - 94 P - P - 95 P - P - 96 P - P - 98 P - P - 99 P - P - 100 P - P - 101 P - - - 102 P - P - 142 - - P - 144 - - P - TAIL 134 P - P - 135 P - P - 136 P - P - 137 P - P - 138 P - - - 139 P - P - 140 P - P - 142 P - P - 143 P - P - 146 P - P - 147 P - P - 148 P - - - 377 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 40 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 SKIN & PELAGE ALOPECIA TAIL 149 P - P - 150 P - P - 151 P - P - 152 P - P - 153 P - P - 154 P - - - 155 P - - - 156 P - - - 157 P - P - 158 - - P - 162 P - P - 163 P - P - 164 P - P - 165 P - P - 166 P - P - 167 P - P - 168 P - P - 169 P - P - 170 P - P - 171 P - P - 172 P - P - 173 P - P - 174 P - P - 175 P - P - 176 P - P - 177 P - P - 178 P - P - 179 P - P - 180 P - P - 181 - - P - 378 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 41 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 SKIN & PELAGE ALOPECIA TAIL 182 P - P - 183 P - P - 184 P - - - 185 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 15 P - - - 22 P - - - 36 P - - - 50 P - - - 57 P - - - 64 P - - - 78 P - - - 85 P - - - 92 P - - - 141 P - - - QUALITATIVE FOOD CONSUMPTION LOW 5 P - - - 8 P - - - 41 P - - - 42 P - - - 69 P - - - 72 P - - - 73 P - - - 75 P - - - 102 P - - - 174 P - - - 179 P - - - 379 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 42 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05530 T 27 DISCHARGE VOMITUS PARTIAL CAPSULE APPEARS TO BE MENSTRUATING 97 - - P - 39 - - P - 40 P - - - 92 P - - - 176 P - - - 180 P - - - EXCRETION DISCOLORED FECES RED IN COLOR LIQUID FECES MUCOID FECES NON-FORMED FECES 28 P - - - 27 P - - - 28 P - P - 29 P - - - 31 - - P - 32 P - - - 33 P - - - 34 P - P - 35 P - - - 36 P - - - 37 P - - - 38 P - P - 39 - - P - 40 P - - - 49 P - - - 50 P - - - 51 P - P - 55 P - - - 28 P - - - 12 P - - - 31 P - - - 380 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 43 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05530 T 27 EXCRETION NON-FORMED FECES 41 P - - - 54 P - - - 55 P - - - 57 P - - - SKIN & PELAGE BROKEN SKIN MOUTH 10 - - P - 12 P - - - 15 P - - - 22 P - - - 23 P - - - 25 P - P - 26 P - P - 27 P - P - 28 P - P - 29 P - P - 30 P - P - 31 P - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 43 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 99 P - - - 106 P - - - 113 P - - - 381 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 44 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05530 T 27 NORMAL NO REMARKABLE OBSERVATIONS 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 183 P - - - 184 P - - P QUALITATIVE FOOD CONSUMPTION LOW 26 P - - - 27 P - - - 29 P - - - 141 P - - - I05531 T 27 DISCHARGE VOMITUS CONTAINING FOOD APPEARS TO BE MENSTRUATING 179 P - - - 176 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 382 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 45 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05531 T 27 NORMAL NO REMARKABLE OBSERVATIONS 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 141 P - - - 179 P - - - 383 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 46 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05535 T 27 DISCHARGE APPEARS TO BE MENSTRUATING 37 - - P - 38 P - - - 108 P - P - 137 P - P - 138 P - - - 166 P - P - 167 P - P - SKIN & PELAGE RED SKIN LIMB-FRONT-RIGHT SCAB(S) LIMB-FRONT-LEFT LIMB-FRONT-RIGHT 22 - - P - 23 - - P - 24 P - P - 183 P - - - 22 - - P - 23 - - P - 24 P - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 384 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 47 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05535 T 27 NORMAL NO REMARKABLE OBSERVATIONS 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 185 P - - P I05544 T 27 DISCHARGE VOMITUS CONTAINING FOOD PARTIAL CAPSULE 141 P - - - 29 - - P - 33 - - P - 34 - - P - 66 - - P - 117 - - P - 141 - - P - DISCHARGE UNKNOWN SOURCE FOUND IN PAN RED IN COLOR 112 P - - - 385 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 48 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05544 T 27 NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 134 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 184 P - - P QUALITATIVE FOOD CONSUMPTION LOW 6 P - - - 36 P - - - 38 P - - - 386 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 49 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05544 T 27 QUALITATIVE FOOD CONSUMPTION LOW 42 P - - - 43 P - - - 127 P - - - 171 P - - - 174 P - - - 176 P - - - I05549 P 79 DISCHARGE VOMITUS INTACT CAPSULE PARTIAL CAPSULE APPEARS TO BE MENSTRUATING 111 - - P - 97 - - P - 175 P - - - SKIN & PELAGE BROKEN SKIN HEAD-CRANIAL PERI-ORBITAL-LEFT 3 - - P - 7 - - P - 8 P - P - 15 P - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 387 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 50 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05549 P 79 NORMAL NO REMARKABLE OBSERVATIONS 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - QUALITATIVE FOOD CONSUMPTION LOW 141 P - - - 175 P - - - 388 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 51 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05537 T 27 DISCHARGE VOMITUS WHITE IN COLOR APPEARS TO BE MENSTRUATING 1 - - P - 45 - - P - 46 - - P - 47 P - - - 48 P - - - 49 - - P - 72 P - P - 73 P - P - 74 P - P - 75 P - - - 104 P - - - 105 P - P - 106 P - P - 107 P - - - 168 P - P - 169 P - P - SKIN & PELAGE BROKEN SKIN HEAD-MAXILLARY-RIGHT PERI-ORBITAL-LEFT PERI-ORBITAL-RIGHT 50 - - P - 52 - - P - 8 P - P - 9 P - P - 10 P - P - 3 P - P - 4 P - - - 6 P - P - 7 - - P - 389 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 52 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05537 T 27 NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 176 P - - - 183 P - - - 184 P - - P 390 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 53 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05541 T 27 DISCHARGE APPEARS TO BE MENSTRUATING 99 - - P - 102 P - - - 152 - - P - 154 - - P - EXCRETION FEW FECES 141 P - - - SKIN & PELAGE BROKEN SKIN PERI-ORBITAL-RIGHT 98 - - P - 99 P - P - 102 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 36 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 106 P - - - 120 P - - - 127 P - - - 134 P - - - 148 P - - - 391 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 54 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05541 T 27 NORMAL NO REMARKABLE OBSERVATIONS 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 3 P - - - 22 P - - - 28 P - - - 29 P - - - 43 P - - - 55 P - - - 57 P - - - 76 P - - - 87 P - - - 113 P - - - 140 P - - - 169 P - - - 174 P - - - 179 P - - - I05547 T 27 DISCHARGE APPEARS TO BE MENSTRUATING 129 P - - - 164 - - P - 165 P - - - 167 P - - - EXCRETION FEW FECES 150 P - - - 392 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 55 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05547 T 27 EXCRETION FEW FECES 151 P - - - 152 P - - - 156 P - - - 168 P - - - NO FECES 154 P - - - 155 P - - - NON-FORMED FECES 178 P - - - 181 - - P - SKIN & PELAGE BROKEN SKIN HEAD-MAXILLARY-LEFT SCAB(S) HEAD-MAXILLARY-LEFT 170 P - P - 171 P - P - 172 P - P - 173 - - P - 174 P - P - 175 P - - - 176 P - - - 178 P - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 50 P - - - 57 P - - - 64 P - - - 393 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 56 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05547 T 27 NORMAL NO REMARKABLE OBSERVATIONS 71 P - - - 78 P - - - 85 P - - - 92 P - - - 106 P - - - 113 P - - - 134 P - - - 141 P - - - 148 P - - - 162 P - - - 169 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 17 P - - - 41 P - - - 43 P - - - 55 P - - - 57 P - - - 66 P - - - 99 P - - - 120 P - - - 121 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 150 P - - - 151 P - - - 152 P - - - 394 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 57 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05547 T 27 QUALITATIVE FOOD CONSUMPTION LOW 154 P - - - 155 P - - - 156 P - - - 160 P - - - 161 P - - - 162 P - - - 165 P - - - 167 P - - - 168 P - - - 169 P - - - 170 P - - - 171 P - - - 174 P - - - 175 P - - - 179 P - - - 184 P - - - I05550 T 27 DISCHARGE APPEARS TO BE MENSTRUATING 91 - - P - 92 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 395 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 58 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 0.03 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05550 T 27 NORMAL NO REMARKABLE OBSERVATIONS 64 P - - - 71 P - - - 78 P - - - 85 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 3 P - - - 141 P - - - 179 P - - - 396 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 59 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05532 T 27 SKIN & PELAGE BROKEN SKIN HEAD-CRANIAL PERI-ORBITAL-RIGHT 2 P - P - 3 P - P - 31 - - P - 32 P - P - 33 - - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 397 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 60 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05532 T 27 NORMAL NO REMARKABLE OBSERVATIONS 184 P - - P QUALITATIVE FOOD CONSUMPTION LOW 26 P - - - 29 P - - - 32 P - - - 41 P - - - 55 P - - - 57 P - - - 58 P - - - 65 P - - - 78 P - - - 85 P - - - 115 P - - - 116 P - - - 120 P - - - 126 P - - - 141 P - - - 143 P - - - 147 P - - - 150 P - - - 155 P - - - 162 P - - - 164 P - - - 169 P - - - 170 P - - - 174 P - - - 175 P - - - 176 P - - - 179 P - - - 183 P - - - 398 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 61 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05538 T 27 DISCHARGE VOMITUS CONTAINING FOOD 141 P - - - 179 P - - - EXCRETION FEW FECES 43 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 399 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05538 T 27 NORMAL NO REMARKABLE OBSERVATIONS 176 P - - - 183 P - - - 184 P - - P QUALITATIVE FOOD CONSUMPTION LOW 27 P - - - 41 P - - - 42 P - - - 43 P - - - 141 P - - - 160 P - - - 167 P - - - 174 P - - - 178 P - - - 179 P - - - I05539 6 81 DISCHARGE APPEARS TO BE MENSTRUATING 71 P - P - EXCRETION FEW FECES 141 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 400 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 63 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05539 6 81 NORMAL NO REMARKABLE OBSERVATIONS 57 P - - - 64 P - - - 78 P - - - 92 P - - - 99 P - - - 106 P - - - 120 P - - - 134 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - QUALITATIVE FOOD CONSUMPTION LOW 17 P - - - 18 P - - - 24 P - - - 57 P - - - 60 P - - - 70 P - - - 85 P - - - 109 P - - - 113 P - - - 116 P - - - 127 P - - - 132 P - - - 133 P - - - 138 P - - - 139 P - - - 401 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 64 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05539 6 81 QUALITATIVE FOOD CONSUMPTION LOW 150 P - - - 155 P - - - 158 P - - - 159 P - - - 162 P - - - 171 P - - - 174 P - - - 179 P - - - I05545 T 27 DISCHARGE APPEARS TO BE MENSTRUATING 136 P - P - EXCRETION NO FECES 51 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 127 P - - - 402 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 65 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05545 T 27 NORMAL NO REMARKABLE OBSERVATIONS 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 176 P - - - 183 P - - - 184 P - - P QUALITATIVE FOOD CONSUMPTION LOW 25 P - - - 30 P - - - 35 P - - - 43 P - - - 74 P - - - 78 P - - - 86 P - - - 113 P - - - 116 P - - - 120 P - - - 141 P - - - 149 P - - - 150 P - - - 155 P - - - 161 P - - - 169 P - - - 171 P - - - 174 P - - - 175 P - - - 176 P - - - 179 P - - - 403 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 66 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05545 T 27 QUALITATIVE FOOD CONSUMPTION LOW 180 P - - - 183 P - - - I05548 T 27 DISCHARGE VOMITUS CONTAINING FOOD 141 P - - - EXCRETION FEW FECES 178 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 404 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 67 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05548 T 27 NORMAL NO REMARKABLE OBSERVATIONS 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 184 P - - P QUALITATIVE FOOD CONSUMPTION LOW 18 P - - - 28 P - - - 58 P - - - 141 P - - - 142 P - - - 174 P - - - I05552 6 81 NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 405 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 68 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05552 6 81 NORMAL NO REMARKABLE OBSERVATIONS 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - QUALITATIVE FOOD CONSUMPTION LOW 20 P - - - 141 P - - - 156 P - - - 406 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 69 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05533 U 79 DISCHARGE APPEARS TO BE MENSTRUATING 39 P - P - 40 P - - - SKIN & PELAGE ALOPECIA HEAD-CRANIAL 22 - - P - 24 - - P - 27 P - P - 28 - - P - 29 P - P - 30 P - P - 31 P - P - 32 P - P - 33 - - P - 34 P - P - 35 P - P - 36 P - P - 37 - - P - 38 P - P - 39 P - P - 40 P - - - 41 P - P - 42 P - P - 43 P - P - 44 - - P - 45 - - P - 48 - - P - 49 - - P - 50 P - P - 51 P - P - 52 P - P - 407 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 70 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05533 U 79 SKIN & PELAGE ALOPECIA HEAD-CRANIAL 53 P - P - 54 P - P - 55 P - P - 56 P - P - 57 P - P - 58 P - P - 59 P - P - 60 - - P - 61 - - P - 62 P - - - HEAD-MAXILLARY-LEFT 27 - - P - 28 - - P - 29 P - P - 30 P - P - 31 P - P - 32 P - P - 33 - - P - 34 P - P - 35 P - P - 36 P - P - 37 - - P - 38 P - P - 39 P - P - 40 P - - - 41 P - P - 42 P - P - 43 P - P - 44 - - P - 45 - - P - 48 - - P - 408 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 71 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05533 U 79 SKIN & PELAGE ALOPECIA HEAD-MAXILLARY-LEFT 49 - - P - 50 P - P - 51 P - P - 52 P - P - 53 P - P - 54 P - P - 55 P - P - 56 P - P - 57 P - P - 58 P - P - 59 P - P - 60 - - P - 61 - - P - 62 P - P - 63 P - P - HEAD-MAXILLARY-RIGHT 27 - - P - 28 - - P - 29 P - P - 30 P - P - 31 P - P - 32 P - P - 33 - - P - 34 P - P - 35 P - P - 36 P - P - 37 - - P - 38 P - P - 39 P - P - 40 P - - - 41 P - P - 409 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 72 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05533 U 79 SKIN & PELAGE ALOPECIA HEAD-MAXILLARY-RIGHT 42 P - P - 43 P - P - 44 - - P - 45 - - P - 48 - - P - 49 - - P - 50 P - P - 51 P - P - 52 P - P - 53 P - P - 54 P - P - 55 P - P - 56 P - P - 57 P - P - 58 P - P - 59 P - P - 60 - - P - 61 - - P - 62 P - P - 63 P - P - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 410 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 73 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05533 U 79 NORMAL NO REMARKABLE OBSERVATIONS 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - QUALITATIVE FOOD CONSUMPTION LOW 141 P - - - I05534 T 27 DISCHARGE VOMITUS PARTIAL CAPSULE APPEARS TO BE MENSTRUATING 6 - - P - 10 - - P - 72 - - P - 59 P - - - 98 P - - - 133 P - - - 134 P - - - EXCRETION DISCOLORED FECES RED IN COLOR 149 P - - - 411 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 74 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05534 T 27 EXCRETION DISCOLORED FECES RED IN COLOR 150 P - - - YELLOW IN COLOR 156 P - - - FEW FECES 102 P - - - 105 P - - - 107 P - - - 109 P - - - 113 P - - - 127 P - - - 163 P - - - LIQUID FECES 92 P - - - 93 P - - - 136 P - - - 137 P - P - 138 P - - - 139 P - - - 141 P - P - 142 P - - - 143 P - - - 144 P - - - 156 P - - - 185 P - - - MUCOID FECES 150 P - - - NO FECES 49 P - - - NON-FORMED FECES 110 P - - - 113 P - - - 127 P - - - 137 P - - - 140 P - - - 144 P - - - 145 P - - - 412 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 75 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05534 T 27 EXCRETION NON-FORMED FECES 146 P - - - 147 P - - - 148 P - - - 149 P - - - 150 P - - - SKIN & PELAGE BROKEN SKIN PERI-ORBITAL-LEFT OTHER 70 - - 71 P - 9 PC - 10 PC - 12 PC - 15 PC - P - P - PC - PC - - - PC - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 29 P - - - 36 P - - - 50 P - - - 57 P - - - 64 P - - - 85 P - - - 99 P - - - 106 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 183 P - - - 185 - - - P 413 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 76 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05534 T 27 QUALITATIVE FOOD CONSUMPTION LOW 2 P - - - 3 P - - - 8 P - - - 10 P - - - 22 P - - - 24 P - - - 38 P - - - 43 P - - - 49 P - - - 60 P - - - 63 P - - - 66 P - - - 78 P - - - 80 P - - - 81 P - - - 92 P - - - 93 P - - - 98 P - - - 100 P - - - 102 P - - - 105 P - - - 109 P - - - 113 P - - - 116 P - - - 120 P - - - 122 P - - - 125 P - - - 127 P - - - 128 P - - - 414 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 77 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05534 T 27 QUALITATIVE FOOD CONSUMPTION LOW 129 P - - - 133 P - - - 134 P - - - 137 P - - - 138 P - - - 141 P - - - 148 P - - - 149 P - - - 150 P - - - 154 P - - - 155 P - - - 156 P - - - 157 P - - - 162 P - - - 164 P - - - 167 P - - - 170 P - - - 174 P - - - 175 P - - - 176 P - - - 180 P - - - 184 P - - - I05536 T 27 DISCHARGE VOMITUS CONTAINING FOOD PARTIAL CAPSULE 141 P - - - 30 - - P - EXCRETION DISCOLORED FECES RED IN COLOR 69 - - P - 415 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 78 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05536 T 27 EXCRETION FEW FECES 88 P - - - LIQUID FECES 88 P - - - NON-FORMED FECES 179 P - - - 183 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 36 P - - - 43 P - - - 50 P - - - 57 P - - - 64 P - - - 71 P - - - 78 P - - - 85 P - - - 92 P - - - 99 P - - - 106 P - - - 113 P - - - 120 P - - - 134 P - - - 148 P - - - 155 P - - - 162 P - - - 169 P - - - 176 P - - - 184 P - - P 416 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 79 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05536 T 27 QUALITATIVE FOOD CONSUMPTION LOW 3 P - - - 65 P - - - 72 P - - - 81 P - - - 88 P - - - 114 P - - - 117 P - - - 126 P - - - 127 P - - - 129 P - - - 130 P - - - 141 P - - - 149 P - - - 156 P - - - 157 P - - - 160 P - - - 180 P - - - 181 P - - - I05540 T 27 DISCHARGE VOMITUS INTACT CAPSULE 99 - - P - EXCRETION DISCOLORED FECES RED IN COLOR DISCOLORED URINE GREEN IN COLOR 27 P - P - 28 P - P - 71 P - - - 417 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 80 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 EXCRETION DISCOLORED URINE GREEN IN COLOR 72 P - - - FEW FECES 28 P - - - 29 P - - - MUCOID FECES 28 - - P - 29 P - - - SKIN & PELAGE ALOPECIA DORSAL DORSAL-THORACIC 1 P - - - 141 - - P - 1 - - P - 2 P - P - 3 - - P - 5 - - P - 6 P - P - 7 P - P - 8 P - P - 9 P - P - 10 P - P - 11 P - P - 12 P - P - 13 P - P - 14 P - P - 15 P - P - 16 P - P - 17 P - P - 18 P - P - 19 P - P - 20 P - P - 21 P - P - 418 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 81 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA DORSAL-THORACIC 22 P - P - 23 P - P - 24 P - P - 25 P - P - 26 P - P - 27 P - P - 28 P - P - 29 P - P - 30 P - P - 31 P - P - 32 P - P - 33 P - P - 34 P - P - 35 P - P - 36 P - P - 37 P - P - 38 P - P - 39 P - P - 40 P - - - 41 P - P - 42 P - P - 43 P - P - 44 - - P - 45 - - P - 46 P - P - 47 P - P - 48 - - P - 49 - - P - 50 P - P - 51 P - - - 419 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 82 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA DORSAL-THORACIC 142 P - P - 143 P - P - 146 P - P - 147 P - P - 148 P - P - 149 P - P - 150 P - P - 151 P - P - 152 P - P - 153 P - P - 154 P - P - 155 P - P - 156 P - P - 157 P - P - 158 P - P - 159 P - P - 160 P - P - 161 P - P - 162 P - P - 163 P - P - 164 P - P - 165 P - P - 166 P - P - 167 P - P - 168 P - P - 169 P - P - 170 P - P - 171 P - P - 172 P - P - 173 P - P - 420 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 83 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA DORSAL-THORACIC 174 P - P - 175 P - P - 176 P - P - 177 P - P - 178 P - P - 179 P - P - 180 P - P - 181 P - P - 182 P - P - 183 P - P - 184 P - P - 185 P - - P DORSAL-THORACIC-LEFT 57 - - P - 58 P - P - 59 P - P - 60 P - P - 61 P - P - 62 P - P - 63 P - P - 64 P - P - 65 P - P - 66 P - P - 67 P - P - 68 P - P - 69 P - P - 70 P - P - 71 P - P - 72 P - P - 73 P - P - 74 P - P - 421 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 84 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA DORSAL-THORACIC-LEFT 76 P - P - 77 P - P - 78 P - - - 79 P - P - 80 P - P - 81 P - P - 82 P - P - 83 P - P - 84 P - P - 85 P - P - 86 P - P - 87 P - P - 88 P - - - 89 P - P - 90 P - P - 91 P - P - 92 P - P - 93 P - P - 94 P - P - 95 P - P - 96 P - P - 97 P - P - 98 P - P - 99 P - P - 100 P - P - 101 - - P - 102 P - P - 103 P - P - 104 P - P - 105 P - P - 422 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 85 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA DORSAL-THORACIC-LEFT 106 P - P - 107 P - P - 108 P - P - 109 P - P - 110 P - P - 111 P - P - 112 P - P - 113 P - P - 114 P - P - 115 P - P - 117 P - P - 118 P - P - 119 P - P - 120 P - P - 121 P - P - 122 P - P - 123 P - P - 124 P - P - 125 P - P - 126 P - P - 127 P - P - 128 P - P - 129 - - P - 130 - - P - 131 - - P - 132 P - P - 133 P - P - 134 P - P - 135 P - P - 136 P - P - 423 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 86 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA DORSAL-THORACIC-LEFT 137 P - P - 138 P - P - 139 P - P - 140 P - P - HEAD-ENTIRE 1 P - P - 2 P - P - 3 - - P - 5 - - P - 6 P - P - 7 P - P - 8 P - P - 9 P - P - 10 P - P - 11 P - P - 12 P - P - 13 P - P - 14 P - P - 15 P - P - 16 P - P - 17 P - P - 18 P - P - 19 P - P - 20 P - P - 21 P - P - 22 P - P - 23 P - P - 24 P - P - 25 P - P - 26 P - P - 27 P - P - 424 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 87 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA HEAD-ENTIRE 28 P - P - 29 P - P - 30 P - P - 31 P - P - 32 P - P - 33 P - P - 34 P - P - 35 P - P - 36 P - P - 37 P - P - 38 P - P - 39 P - P - 40 P - - - 41 P - P - LIMB-HIND-LEFT 57 - - P - 58 P - P - 59 P - P - 60 P - P - 61 P - P - 62 P - P - 63 P - P - 64 P - P - 65 P - P - 66 P - P - 67 P - P - 68 P - P - 69 P - P - 70 P - P - 71 P - P - 72 P - P - 425 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 88 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA LIMB-HIND-LEFT 73 P - P - 74 P - P - 76 P - P - 77 P - P - 78 P - - - 79 P - P - 80 P - P - 81 P - P - 82 P - P - 83 P - P - 84 P - P - 85 P - P - 86 P - P - 87 P - P - 88 P - - - 89 P - P - 90 P - P - 91 P - P - 92 P - P - 93 P - P - 94 P - P - 95 P - P - 96 P - P - 97 P - P - 98 P - P - 99 P - P - 100 P - P - 101 - - P - 102 P - P - 103 P - P - 426 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 89 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA LIMB-HIND-LEFT 104 P - - - LIMBS-ALL 42 P - P - 43 P - P - 44 - - P - 45 - - P - 46 P - P - 47 P - P - 48 - - P - 49 - - P - 50 P - P - 51 P - P - 52 P - P - 53 P - P - 54 P - P - 55 P - P - 56 P - - - 57 P - - - LIMBS-FRONT 1 P - P - 2 P - P - 3 - - P - 5 - - P - 6 P - P - 7 P - P - 8 P - P - 9 P - P - 10 P - P - 11 P - P - 12 P - P - 13 P - P - 14 P - P - 427 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 90 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA LIMBS-FRONT 15 P - P - 16 P - P - 17 P - P - 18 P - P - 19 P - P - 20 P - P - 21 P - P - 22 P - P - 23 P - P - 24 P - P - 25 P - P - 26 P - P - 27 P - P - 28 P - P - 29 P - P - 30 P - P - 31 P - P - 32 P - P - 33 P - P - 34 P - P - 35 P - P - 36 P - P - 37 P - P - 38 P - P - 39 P - P - 40 P - - - 41 P - P - TAIL 145 - - P - 146 P - P - 147 P - P - 428 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA TAIL 148 P - P - 149 P - P - 150 P - P - 151 P - P - 152 P - P - 153 P - P - 154 P - P - 155 P - P - 156 P - P - 157 P - P - 158 P - P - 159 P - P - 160 P - P - 161 P - P - 162 P - P - 163 P - P - 164 P - P - 165 P - P - 166 P - P - 167 P - P - 168 P - P - 169 P - P - 170 P - P - 171 P - P - 172 P - P - 173 P - P - 174 P - P - 175 P - P - 176 P - P - 177 P - P - 429 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 92 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05540 T 27 SKIN & PELAGE ALOPECIA TAIL 178 P - P - 179 P - P - 180 P - P - 181 P - P - 182 P - P - 183 P - P - 184 P - P - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 17 P - - - 20 P - - - 25 P - - - 27 P - - - 69 P - - - 71 P - - - 73 P - - - 74 P - - - 78 P - - - 80 P - - - 85 P - - - 87 P - - - 120 P - - - 132 P - - - 137 P - - - 141 P - - - 155 P - - - 179 P - - - 430 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 93 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== I05542 U 79 DISCHARGE VOMITUS INTACT CAPSULE PARTIAL CAPSULE APPEARS TO BE MENSTRUATING 136 P - P - 65 - - P - 78 - - P - 126 - - P - 131 - - P - 71 P - P - 115 P - - - 161 P - - - EXCRETION FEW FECES 155 P - - - 161 P - - - 162 P - - - SKIN & PELAGE PALE SKIN HEAD-ENTIRE 182 - - P - 183 P - - - 184 P - - - NORMAL NO REMARKABLE OBSERVATIONS 1 P - - - 8 P - - - 15 P - - - 22 P - - - 29 P - - - 50 P - - - 57 P - - - 64 P - - - 85 P - - - 431 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 94 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05542 U 79 NORMAL NO REMARKABLE OBSERVATIONS 99 P - - - 106 P - - - 113 P - - - 120 P - - - 127 P - - - 134 P - - - 141 P - - - 148 P - - - 169 P - - - 176 P - - - QUALITATIVE FOOD CONSUMPTION LOW 14 P - - - 36 P - - - 43 P - - - 49 P - - - 57 P - - - 59 P - - - 60 P - - - 65 P - - - 78 P - - - 92 P - - - 98 P - - - 125 P - - - 134 P - - - 139 P - - - 141 P - - - 142 P - - - 143 P - - - 154 P - - - 155 P - - - 432 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 95 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05542 U 79 QUALITATIVE FOOD CONSUMPTION LOW 161 P - - - 162 P - - - 175 P - - - I05551 T 27 DISCHARGE APPEARS TO BE MENSTRUATING 43 - - P - 44 - - P - 45 - - P - 73 P - P - 74 P - P - 75 P - P - 76 P - P - 80 P - - - 112 P - P - 113 P - P - 137 - - P - 138 P - P - 139 P - P - 140 P - P - 141 P - P - 166 P - P - 167 P - P - 168 P - - - EXCRETION FEW FECES SMALL FECES 161 P - - - 49 P - P - SKIN & PELAGE ALOPECIA LIMBS-ALL 1 P - P - 433 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 96 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05551 T 27 SKIN & PELAGE ALOPECIA LIMBS-ALL 2 P - P - 3 - - P - 4 - - P - 5 - - P - 6 P - P - 7 P - P - 8 P - P - 9 P - P - 10 P - P - 11 P - P - 12 P - P - 13 P - P - 14 P - P - 15 P - P - 16 P - P - 17 P - P - 18 P - P - 19 P - P - 20 P - P - 21 P - P - 22 P - P - 23 P - P - 24 P - P - 25 P - P - 26 P - P - 27 P - P - 28 P - P - 29 P - P - 30 P - P - 31 P - P - 434 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 97 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05551 T 27 SKIN & PELAGE ALOPECIA LIMBS-ALL 32 P - P - 33 P - P - 34 P - P - 35 P - P - 36 P - P - 37 P - P - 38 P - P - 39 P - P - 40 P - P - 41 P - P - 42 P - P - 43 P - P - 44 - - P - 45 - - P - 46 P - P - 47 P - P - 48 - - P - 49 P - P - 50 P - P - 51 P - P - 52 P - P - 53 P - P - 54 P - P - 55 P - P - 56 P - P - 57 P - P - 58 P - P - 59 P - P - 60 P - P - 61 P - P - 435 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 98 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05551 T 27 SKIN & PELAGE ALOPECIA LIMBS-ALL 62 P - P - 63 P - P - 64 P - P - 65 P - P - 66 P - P - 67 P - P - 68 P - P - 69 P - P - 70 P - P - 71 P - P - 72 P - P - 73 P - P - 74 P - P - 75 P - P - 76 P - P - 77 P - P - 78 P - P - 79 P - P - 80 P - P - 81 P - P - 82 P - P - 83 P - P - 84 P - P - 85 P - P - 86 P - P - 87 P - P - 88 P - P - 89 P - P - 90 P - P - 91 P - P - 436 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 99 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05551 T 27 SKIN & PELAGE ALOPECIA LIMBS-ALL 92 P - P - 93 P - P - 94 P - P - 95 P - P - 96 P - P - 97 P - P - 98 P - P - 99 P - P - 100 P - P - 101 - - P - 102 P - P - 103 P - P - 104 P - P - 105 P - P - 106 P - P - 107 P - P - 108 P - P - 109 P - P - 110 P - P - 111 P - P - 112 P - P - 113 P - P - 114 P - P - 115 P - P - 116 - - P - 117 P - P - 118 P - P - 119 P - P - 120 P - P - 121 P - P - 437 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 100 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05551 T 27 SKIN & PELAGE ALOPECIA LIMBS-ALL 122 P - P - 123 P - P - 124 P - P - 125 P - P - 126 P - P - 127 P - P - 128 P - P - 129 - - P - 130 - - P - 131 - - P - 132 P - P - 133 P - P - 134 P - P - 135 P - P - 136 P - P - 137 P - P - 138 P - P - 139 P - P - 140 P - P - 141 - - P - 142 P - P - 143 P - P - 144 - - P - 145 - - P - 146 P - P - 147 P - P - 148 P - P - 149 P - P - 150 P - P - 151 P - P - 438 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 101 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05551 T 27 SKIN & PELAGE ALOPECIA LIMBS-ALL 152 P - P - 153 P - P - 154 P - P - 155 P - P - 156 P - P - 157 P - P - 158 P - P - 159 P - P - 160 P - P - 161 P - P - 162 P - P - 163 P - P - 164 P - P - 165 P - P - 166 P - P - 167 P - P - 168 P - P - 169 P - P - 170 P - P - 171 P - P - 172 P - P - 173 P - P - 174 P - P - 175 P - P - 176 P - P - 177 P - P - 178 P - P - 179 P - P - 180 P - P - 181 P - P - 439 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 102 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 1-185 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05551 T 27 SKIN & PELAGE ALOPECIA LIMBS-ALL 182 P - P - 183 P - P - 184 P - P - 185 P - - P QUALITATIVE FOOD CONSUMPTION LOW 72 P - - - 85 P - - - 102 P - - - 146 P - - - 162 P - - - 440 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Treatment PAGE: 103 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY STUDY KEYWORD ANIMAL GROUP DAY WK QUALIFIER FREE-TEXT COMMENT ------------------------------------------------------------------------------------------------------------------------------------ I05534 F4 9 2 TO 15 3 SKIN & PELAGE OTHER BRUISED SKIN PERI-ORBITAL LEFT EYE. 441 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== I05520 O 79 SKIN & PELAGE BROKEN SKIN DIGIT(S)-FRONT-LEFT 361 P - - - 362 P - - - NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 281 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - 442 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05520 O 79 QUALITATIVE FOOD CONSUMPTION LOW 273 P - - - I05526 O 79 NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 281 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - 443 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== I05505 6 81 EXCRETION NON-FORMED FECES 191 P - - - NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 281 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - 444 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05505 6 81 QUALITATIVE FOOD CONSUMPTION LOW 240 P - - - I05523 6 81 NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 281 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - 445 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05523 6 81 QUALITATIVE FOOD CONSUMPTION LOW 247 P - - - 446 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== I05511 U 79 NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 281 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - QUALITATIVE FOOD CONSUMPTION LOW 255 P - - - 447 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== I05522 U 79 NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 281 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - 448 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 8 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== I05529 P 79 EXCRETION LIQUID FECES 277 P - - - 278 P - - - 306 P - - - 308 P - - - SKIN & PELAGE ALOPECIA FEET 186 P - - - 187 P - - - 188 P - - - 189 P - - - 190 P - - - 191 P - - - 192 P - - - 193 P - - - 194 P - - - 195 P - - - 197 P - - - 200 P - - - 201 P - - - 203 P - - - 204 P - - - 206 P - - - 210 P - - - 211 P - - - 213 P - - - 216 P - - - 217 P - - - 218 P - - - 219 P - - - 220 P - - - 449 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 9 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 SKIN & PELAGE ALOPECIA FEET 221 P - - - 222 P - - - 223 P - - - 225 P - - - 226 P - - - 229 P - - - 230 P - - - 231 P - - - 232 P - - - 233 P - - - 234 P - - - 235 P - - - 236 P - - - 237 P - - - 238 P - - - 239 P - - - 240 P - - - 241 P - - - 244 P - - - 245 P - - - 246 P - - - 247 P - - - 248 P - - - 251 P - - - 252 P - - - 253 P - - - 254 P - - - 255 P - - - 257 P - - - 258 P - - - 450 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 10 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 SKIN & PELAGE ALOPECIA FEET 259 P - - - 260 P - - - 261 P - - - 263 P - - - 264 P - - - 265 P - - - 266 P - - - 267 P - - - 268 P - - - 269 P - - - 272 P - - - 273 P - - - 274 P - - - 275 P - - - 276 P - - - 277 P - - - 278 P - - - 279 P - - - 280 P - - - 281 P - - - 288 P - - - 289 P - - - 294 P - - - 295 P - - - 298 P - - - 301 P - - - 302 P - - - 305 P - - - 306 P - - - 308 P - - - 451 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 11 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 SKIN & PELAGE ALOPECIA FEET 309 P - - - 310 P - - - 311 P - - - 314 P - - - TAIL 186 P - - - 187 P - - - 188 P - - - 189 P - - - 190 P - - - 191 P - - - 192 P - - - 193 P - - - 194 P - - - 195 P - - - 197 P - - - 200 P - - - 201 P - - - 203 P - - - 204 P - - - 206 P - - - 210 P - - - 211 P - - - 213 P - - - 216 P - - - 217 P - - - 218 P - - - 219 P - - - 220 P - - - 221 P - - - 222 P - - - 452 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 12 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 SKIN & PELAGE ALOPECIA TAIL 223 P - - - 225 P - - - 226 P - - - 229 P - - - 230 P - - - 231 P - - - 232 P - - - 233 P - - - 234 P - - - 235 P - - - 236 P - - - 237 P - - - 238 P - - - 239 P - - - 240 P - - - 241 P - - - 244 P - - - 245 P - - - 246 P - - - 247 P - - - NORMAL NO REMARKABLE OBSERVATIONS 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - 453 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 13 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 QUALITATIVE FOOD CONSUMPTION LOW 195 P - - - 210 P - - - 247 P - - - 248 P - - - 260 P - - - 272 P - - - 273 P - - - 294 P - - - I05549 P 79 DISCHARGE APPEARS TO BE MENSTRUATING 261 P - - - NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 281 P - - - 288 P - - - 295 P - - - 454 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 14 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05549 P 79 NORMAL NO REMARKABLE OBSERVATIONS 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - QUALITATIVE FOOD CONSUMPTION LOW 195 P - - - 231 P - - - 248 P - - - 272 P - - - 455 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 15 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== I05539 6 81 DISCHARGE APPEARS TO BE MENSTRUATING 216 P - - - 217 P - - - 246 P - - - 275 P - - - EXCRETION FEW FECES 191 P - - - 195 P - - - NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 281 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 456 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 16 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05539 6 81 NORMAL NO REMARKABLE OBSERVATIONS 344 P - - - 351 P - - - 358 P - - - 365 P - - - QUALITATIVE FOOD CONSUMPTION LOW 191 P - - - 195 P - - - 213 P - - - 218 P - - - 251 P - - - 254 P - - - 259 P - - - 269 P - - - 316 P - - - 346 P - - - I05552 6 81 NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 457 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 17 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05552 6 81 NORMAL NO REMARKABLE OBSERVATIONS 281 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - QUALITATIVE FOOD CONSUMPTION LOW 220 P - - - 343 P - - - 344 P - - - 346 P - - - 458 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 18 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== I05533 U 79 EXCRETION NON-FORMED FECES 245 P - - - NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 260 P - - - 267 P - - - 274 P - - - 281 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 344 P - - - 351 P - - - 358 P - - - 365 P - - - 459 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 19 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05533 U 79 QUALITATIVE FOOD CONSUMPTION LOW 241 P - - - 244 P - - - 343 P - - - I05542 U 79 DISCHARGE APPEARS TO BE MENSTRUATING 260 P - - - 299 P - - - NORMAL NO REMARKABLE OBSERVATIONS 190 P - - - 197 P - - - 204 P - - - 211 P - - - 218 P - - - 225 P - - - 232 P - - - 239 P - - - 246 P - - - 253 P - - - 267 P - - - 274 P - - - 288 P - - - 295 P - - - 302 P - - - 309 P - - - 316 P - - - 323 P - - - 330 P - - - 337 P - - - 460 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 186 through 365) PAGE: 20 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCHED 30-90 OB DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 186-365 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05542 U 79 NORMAL NO REMARKABLE OBSERVATIONS 344 P - - - 351 P - - - 358 P - - - 365 P - - - QUALITATIVE FOOD CONSUMPTION LOW 269 P - - - 273 P - - - 275 P - - - 281 P - - - 302 P - - - 343 P - - - 344 P - - - 461 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== I05520 O 79 EXCRETION NON-FORMED FECES 533 P - - - 534 P - - - NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 379 P - - - 386 P - - - 393 P - - - 400 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 484 P - - - 491 P - - - 498 P - - - 505 P - - - 512 P - - - 519 P - - - 526 P - - - 540 P - - - 547 P - - - 462 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05520 O 79 QUALITATIVE FOOD CONSUMPTION LOW 541 P - - - I05526 O 79 DISCHARGE VOMITUS CONTAINING FOOD 535 P - - - 541 P - - - NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 379 P - - - 386 P - - - 393 P - - - 400 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 484 P - - - 491 P - - - 498 P - - - 505 P - - - 512 P - - - 463 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05526 O 79 NORMAL NO REMARKABLE OBSERVATIONS 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - 464 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== I05505 6 81 APPEARANCE SWOLLEN HEAD-MAXILLARY-RIGHT 390 P - - - 391 P - - - 393 P - - - 394 P - - - 395 P - - - 397 P - - - 400 P - - - DISCHARGE VOMITUS CONTAINING FOOD 535 P - - - EXCRETION FEW FECES 555 P - - - NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 379 P - - - 386 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 465 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05505 6 81 NORMAL NO REMARKABLE OBSERVATIONS 484 P - - - 491 P - - - 498 P - - - 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - 554 P - - - QUALITATIVE FOOD CONSUMPTION LOW 375 P - - - 376 P - - - 555 P - - - I05523 6 81 DISCHARGE VOMITUS CONTAINING FOOD 535 P - - - EXCRETION NO FECES NON-FORMED FECES 555 P - - - 556 P - - - 557 P - - - NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 386 P - - - 393 P - - - 400 P - - - 466 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05523 6 81 NORMAL NO REMARKABLE OBSERVATIONS 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 484 P - - - 491 P - - - 498 P - - - 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - 554 P - - - QUALITATIVE FOOD CONSUMPTION LOW 375 P - - - 379 P - - - 553 P P - - 555 P - - - 558 P - - - 467 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== I05511 U 79 NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 379 P - - - 386 P - - - 393 P - - - 400 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 484 P - - - 491 P - - - 498 P - - - 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - 549 P - - P 468 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 8 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== I05522 U 79 EXCRETION NON-FORMED FECES 402 P - - - 403 P - - - NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 379 P - - - 386 P - - - 393 P - - - 400 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 484 P - - - 491 P - - - 498 P - - - 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - 549 P - - P 469 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 9 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05522 U 79 QUALITATIVE FOOD CONSUMPTION LOW 394 P - - - 470 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 10 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== I05529 P 79 EXCRETION LIQUID FECES NON-FORMED FECES 489 P - - - 491 P - - - 492 P - - - 493 P - - - 494 P - - - 496 P - - - SKIN & PELAGE ALOPECIA LIMB-HIND-RIGHT 368 P - - - 369 P - - - 372 P - - - 376 P - - - 377 P - - - 378 P - - - 549 P - - - NORMAL NO REMARKABLE OBSERVATIONS 379 P - - - 386 P - - - 393 P - - - 400 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 471 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 11 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05529 P 79 NORMAL NO REMARKABLE OBSERVATIONS 470 P - - - 477 P - - - 484 P - - - 498 P - - - 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - QUALITATIVE FOOD CONSUMPTION LOW 372 P - - - 376 P - - - 452 P - - - I05549 P 79 DISCHARGE VOMITUS CONTAINING FOOD APPEARS TO BE MENSTRUATING 535 P - - - 372 P - - - 400 P - - - 456 P - - - 484 P - - - 541 P - - - NORMAL NO REMARKABLE OBSERVATIONS 379 P - - - 386 P - - - 393 P - - - 407 P - - - 472 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 12 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05549 P 79 NORMAL NO REMARKABLE OBSERVATIONS 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 463 P - - - 470 P - - - 477 P - - - 491 P - - - 498 P - - - 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - QUALITATIVE FOOD CONSUMPTION LOW 372 P - - - 452 P - - - 473 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 13 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== I05539 6 81 DISCHARGE UNKNOWN SOURCE FOUND IN PAN RED IN COLOR 555 P - - - 556 P - - - EXCRETION FEW FECES NO FECES 404 P - - - 558 P - - - 555 P - - - 556 P - - - 557 P - - - NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 379 P - - - 386 P - - - 393 P - - - 400 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 484 P - - - 491 P - - - 498 P - - - 474 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 14 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05539 6 81 NORMAL NO REMARKABLE OBSERVATIONS 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - 554 P - - - QUALITATIVE FOOD CONSUMPTION LOW NONE 375 P - - - 376 P - - - 399 P - - - 404 P - - - 407 P - - - 553 - P - - 556 P - - - 557 P - - - 558 P - - - 555 P - - - I05552 6 81 DISCHARGE VOMITUS CONTAINING FOOD 535 P - - - EXCRETION FEW FECES NO FECES 555 P - - - 557 P - - - 558 P - - - 556 P - - - 475 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 15 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05552 6 81 NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 379 P - - - 386 P - - - 393 P - - - 400 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 484 P - - - 491 P - - - 498 P - - - 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - 554 P - - - 476 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 16 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05552 6 81 QUALITATIVE FOOD CONSUMPTION LOW NONE 372 P - - - 557 P - - - 558 P - - - 555 P - - - 556 P - - - 477 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 17 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== I05533 U 79 EXCRETION LIQUID FECES NON-FORMED FECES 399 P - - - 400 P - - - 402 P - - - NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 379 P - - - 386 P - - - 393 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 484 P - - - 491 P - - - 498 P - - - 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - 549 P - - P 478 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 18 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05533 U 79 QUALITATIVE FOOD CONSUMPTION LOW 394 P - - - I05542 U 79 DISCHARGE APPEARS TO BE MENSTRUATING 496 P - - - DISCHARGE UNKNOWN SOURCE FOUND IN PAN RED IN COLOR 375 P - - - NORMAL NO REMARKABLE OBSERVATIONS 372 P - - - 379 P - - - 386 P - - - 393 P - - - 400 P - - - 407 P - - - 414 P - - - 421 P - - - 428 P - - - 435 P - - - 442 P - - - 449 P - - - 456 P - - - 463 P - - - 470 P - - - 477 P - - - 484 P - - - 491 P - - - 498 P - - - 479 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Clinical Observations Recovery (Days 366 through 561) PAGE: 19 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY 'C' - COMMENTS LISTED AT END OF OBSERVATIONS FOR SEX/GROUP ANIMAL DEATH WK OF KEYWORD AM OBS UNSCH EXTRA DISPATCH NUMBER CODE DEATH QUALIFIER DAYS 368-558 DAY ==================================================================================================================================== (CONTINUED FROM PREVIOUS PAGE) I05542 U 79 NORMAL NO REMARKABLE OBSERVATIONS 505 P - - - 512 P - - - 519 P - - - 526 P - - - 533 P - - - 540 P - - - 547 P - - - 549 P - - P QUALITATIVE FOOD CONSUMPTION LOW 375 P - - - 394 P - - - 395 P - - - 480 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Treatment PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEKS -4 AND 26 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05508 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05517 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05519 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05520 O 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05526 O 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05527 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 481 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Treatment PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M2 DOSE: 0.03 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEKS -4 AND 26 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05514 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05515 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05516 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05521 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 482 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Treatment PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEKS -4 AND 26 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05505 6 81 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05510 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05518 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05523 6 81 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05524 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05528 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 483 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Treatment PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEKS -4 AND 26 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05506 M 26 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05507 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05509 D 23 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4 I05511 U 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05512 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05522 U 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 484 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Treatment PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEKS -4 AND 26 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05529 P 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYE-LEFT -4 EYES 26 MISCELLANEOUS OPHTHALMICS INCREASED MYELINATION OF OPTIC NERVE EYE-RIGHT -4 I05530 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05531 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05535 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05544 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05549 P 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 485 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Treatment PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 0.03 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEKS -4 AND 26 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05537 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05541 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05547 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05550 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 486 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Treatment PAGE: 7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEKS -4 AND 26 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05532 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05538 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05539 6 81 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05545 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05548 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05552 6 81 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 487 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Treatment PAGE: 8 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEKS -4 AND 26 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05533 U 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05534 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05536 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05540 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05542 U 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 I05551 T 27 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES -4, 26 488 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Recovery PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M1 DOSE: 0 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEK 52 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05520 O 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 I05526 O 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 489 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Recovery PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 0.15 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEK 52 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05505 6 81 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 I05523 6 81 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 490 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Recovery PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 0.75 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEK 52 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05511 U 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 I05522 U 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 491 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Recovery PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F1 DOSE: 0 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEK 52 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05529 P 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYE-LEFT 52 MISCELLANEOUS OPHTHALMICS OTHER EYE-RIGHT 52C I05549 P 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 492 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Recovery PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY STUDY KEYWORD ANIMAL GROUP DAY WK QUALIFIER FREE-TEXT COMMENT ------------------------------------------------------------------------------------------------------------------------------------ I05529 F1 363 52 MISCELLANEOUS OPHTHALMICS OTHER EYE-RIGHT INCREASED MYELINATION OF OPTIC NERVE HEAD THAT MAY BE ASSOCIATED WITH OPTIC NEURITIS. MACULA NORMAL. 493 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Recovery PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F3 DOSE: 0.15 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEK 52 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05539 6 81 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 I05552 6 81 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 494 Appendix 2 Covance 6329-223 3M T-6295.7 Individual Ophthalmic Observations Recovery PAGE: 7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F4 DOSE: 0.75 MG/KG/DAY ANIMAL DEATH WK OF KEYWORD WEEK 52 - OBSERVED DURING THE WEEKS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERVATIONS ------------------------------------------------------------------------------------------------------------------------------------ I05533 U 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 I05542 U 79 NO VISIBLE LESIONS NO VISIBLE LESIONS EYES 52 495 APPENDIX 3 Individual Body Weight Data (kg) Covance 6329-223 3M T-6295.7 496 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Treatment Phase PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL a WEEK b WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER -1 -1 1 2 3 4 5 6 7 8 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: MALE 1 - 0 MG/KG/DAY I05508 I05517 I05519 I05520 I05526 I05527 3.0 3.1 3.1 3.1 3.2 3.2 3.2 3.2 3.2 3.2 3.4 3.4 3.4 3.3 3.2 3.2 3.3 3.3 3.3 3.3 2.9 3.0 3.0 3.0 3.0 3.1 3.1 3.0 3.0 3.1 2.9 2.9 2.9 2.9 3.0 3.1 3.0 3.0 2.9 3.0 3.0 3.0 3.0 3.1 3.2 3.3 3.3 3.3 3.3 3.3 4.0 4.1 4.1 4.1 4.1 4.1 4.1 4.1 4.1 4.1 GROUP: MALE 2 - 0.03 MG/KG/DAY I05514 I05515 I05516 I05521 3.1 3.1 3.1 3.2 3.2 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.2 3.3 3.4 3.4 3.5 3.4 3.4 2.7 2.8 2.8 2.8 2.8 2.9 2.9 2.9 2.9 2.9 4.4 4.3 4.4 4.3 4.4 4.4 4.4 4.4 4.4 4.4 GROUP: MALE 3 - 0.15 MG/KG/DAY I05505 I05510 I05518 I05523 I05524 I05528 3.1 3.2 3.2 3.2 3.3 3.3 3.3 3.3 3.3 3.2 2.9 3.0 2.9 2.9 2.9 3.0 3.0 3.0 3.1 3.1 3.0 3.1 3.1 3.1 3.1 3.2 3.2 3.2 3.2 3.2 2.6 2.7 2.7 2.7 2.8 2.8 2.8 2.8 2.8 2.8 2.9 2.9 2.9 3.0 3.1 3.1 3.1 3.1 3.1 3.0 3.6 3.7 3.7 3.7 3.7 3.8 3.8 3.8 3.8 3.7 GROUP: MALE 4 - 0.75 MG/KG/DAY I05506 I05507 I05509 I05511 I05512 I05522 3.3 3.4 3.4 3.4 3.5 3.5 3.6 3.7 3.7 3.7 4.4 4.4 4.4 4.5 4.5 4.5 4.5 4.5 4.6 4.6 3.1 3.2 3.2 3.1 3.2 3.2 3.3 3.3 3.2 3.2 2.8 2.9 2.9 2.9 2.9 2.9 2.8 2.8 2.8 2.8 2.8 2.9 2.9 2.8 2.9 3.0 3.0 3.0 3.1 3.0 3.4 3.4 3.4 3.4 3.5 3.6 3.6 3.6 3.6 3.6 a Day -7. b Day -1. 497 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Treatment Phase PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL a WEEK b WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER -1 -1 1 2 3 4 5 6 7 8 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: FEMALE 1 - 0 MG/KG/DAY I05529 I05530 I05531 I05535 I05544 I05549 2.5 2.5 2.5 2.7 2.3 2.4 2.4 2.4 2.4 2.4 2.9 2.9 2.9 2.8 2.9 2.9 2.7 2.7 2.8 2.8 2.6 2.6 2.6 2.6 2.6 2.7 2.6 2.6 2.7 2.6 3.4 3.3 3.3 3.3 3.4 3.4 3.4 3.4 3.5 3.5 2.6 2.7 2.7 2.6 2.6 2.7 2.7 2.6 2.6 2.6 2.9 2.9 2.9 2.9 3.0 3.0 3.0 3.0 3.0 3.0 GROUP: FEMALE 2 - 0.03 MG/KG/DAY I05537 I05541 I05547 I05550 3.8 3.8 3.9 3.9 3.9 4.0 3.9 3.9 4.0 4.0 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.6 2.6 2.6 2.9 2.9 2.9 3.0 3.0 3.0 3.0 3.0 3.0 3.0 2.9 2.9 2.9 2.9 2.9 2.8 2.8 2.8 2.9 2.9 GROUP: FEMALE 3 - 0.15 MG/KG/DAY I05532 I05538 I05539 I05545 I05548 I05552 2.7 2.7 2.7 2.7 2.7 2.7 2.7 2.7 2.8 2.8 3.2 3.2 3.2 3.1 3.1 3.0 3.0 3.0 3.0 3.0 3.6 3.7 3.7 3.8 3.8 3.8 3.8 3.9 3.9 3.9 2.6 2.6 2.6 2.7 2.7 2.7 2.6 2.6 2.6 2.6 2.8 2.9 2.9 3.0 2.9 3.0 3.0 3.0 3.0 3.0 2.8 2.8 2.8 2.7 2.7 2.7 2.7 2.7 2.7 2.7 GROUP: FEMALE 4 - 0.75 MG/KG/DAY I05533 I05534 I05536 I05540 I05542 I05551 2.6 2.6 2.6 2.6 2.6 2.6 2.5 2.6 2.6 2.5 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 3.9 3.9 3.9 3.8 3.8 3.9 3.9 3.9 3.8 3.8 2.9 3.0 3.0 3.1 3.1 2.8 2.6 2.6 2.8 2.9 2.8 2.9 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.3 2.4 2.4 2.4 2.4 2.4 2.4 2.3 2.4 2.4 a Day -7. b Day -1. 498 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Treatment Phase PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 9 10 11 12 13 14 15 16 17 18 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: MALE 1 - 0 MG/KG/DAY I05508 I05517 I05519 I05520 I05526 I05527 3.2 3.2 3.2 3.3 3.3 3.3 3.3 3.3 3.4 3.4 3.4 3.3 3.3 3.3 3.3 3.3 3.3 3.1 3.3 3.3 3.1 3.1 3.1 3.1 3.2 3.2 3.2 3.2 3.3 3.2 3.0 3.0 3.1 3.0 3.0 3.1 3.0 3.0 3.0 3.0 3.4 3.4 3.5 3.5 3.6 3.5 3.6 3.6 3.7 3.7 4.2 4.2 4.3 4.3 4.3 4.3 4.3 4.3 4.4 4.4 GROUP: MALE 2 - 0.03 MG/KG/DAY I05514 I05515 I05516 I05521 3.3 3.3 3.4 3.4 3.4 3.4 3.5 3.5 3.6 3.5 3.5 3.5 3.6 3.7 3.7 3.6 3.6 3.7 3.8 3.7 3.0 3.0 3.0 3.0 3.1 3.2 3.2 3.2 3.3 3.2 4.4 4.4 4.6 4.6 4.6 4.5 4.6 4.6 4.6 4.5 GROUP: MALE 3 - 0.15 MG/KG/DAY I05505 I05510 I05518 I05523 I05524 I05528 3.3 3.2 3.3 3.3 3.3 3.2 3.3 3.3 3.3 3.3 3.1 3.1 3.2 3.2 3.3 3.1 3.2 3.2 3.3 3.3 3.3 3.2 3.2 3.3 3.3 3.2 3.2 3.3 3.3 3.3 2.8 2.7 2.8 2.8 2.9 2.9 2.9 2.9 3.0 2.9 3.2 3.0 3.1 3.1 3.1 3.1 3.1 3.1 3.0 3.2 3.7 3.7 3.8 3.7 3.7 3.8 3.8 3.7 3.7 3.6 GROUP: MALE 4 - 0.75 MG/KG/DAY I05506 I05507 I05509 I05511 I05512 I05522 3.8 3.7 3.9 3.8 3.9 3.8 3.9 3.9 4.0 3.9 4.7 4.6 4.7 4.7 4.7 4.6 4.6 4.5 4.6 4.5 3.2 3.2 3.2 3.2 3.2 3.1 3.1 3.0 3.1 3.0 2.9 2.8 2.9 2.9 2.9 2.9 2.9 2.8 2.7 2.8 3.1 3.0 3.1 3.1 3.1 2.9 2.9 2.7 2.8 2.8 3.6 3.6 3.7 3.6 3.7 3.7 3.7 3.6 3.7 3.7 499 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Treatment Phase PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 9 10 11 12 13 14 15 16 17 18 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: FEMALE 1 - 0 MG/KG/DAY I05529 I05530 I05531 I05535 I05544 I05549 2.5 2.5 2.5 2.6 2.6 2.6 2.4 2.5 2.5 2.5 2.9 2.9 3.0 3.1 3.0 3.0 3.0 3.0 3.0 3.0 2.7 2.6 2.7 2.7 2.7 2.7 2.7 2.7 2.8 2.8 3.6 3.5 3.5 3.6 3.6 3.6 3.5 3.5 3.6 3.6 2.6 2.7 2.7 2.7 2.8 2.7 2.7 2.8 2.8 2.7 3.0 3.0 2.9 3.0 3.0 3.0 3.0 3.0 3.1 3.0 GROUP: FEMALE 2 - 0.03 MG/KG/DAY I05537 I05541 I05547 I05550 4.1 4.0 4.0 4.0 4.1 4.1 4.1 4.1 4.2 4.2 2.6 2.6 2.7 2.7 2.7 2.7 2.7 2.7 2.6 2.7 3.0 3.0 3.0 3.1 3.1 3.1 3.0 3.0 3.0 3.0 2.9 2.8 2.8 2.8 2.9 2.9 2.9 2.9 2.9 2.9 GROUP: FEMALE 3 - 0.15 MG/KG/DAY I05532 I05538 I05539 I05545 I05548 I05552 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.9 2.8 3.0 3.0 3.2 3.2 3.3 3.2 3.3 3.3 3.4 3.4 3.9 3.9 3.9 3.9 3.9 4.0 4.0 3.9 3.9 3.9 2.6 2.7 2.7 2.6 2.6 2.7 2.7 2.7 2.7 2.6 3.0 3.0 3.0 3.1 3.1 3.1 3.1 3.0 3.1 3.0 2.8 2.8 2.7 2.7 2.8 2.8 2.8 2.8 2.8 2.8 GROUP: FEMALE 4 - 0.75 MG/KG/DAY I05533 I05534 I05536 I05540 I05542 I05551 2.6 2.6 2.6 2.7 2.7 2.6 2.6 2.6 2.7 2.6 2.9 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.9 2.9 3.9 3.9 3.8 3.8 3.7 3.6 3.5 3.4 3.7 3.6 3.1 3.0 2.8 2.8 2.8 2.7 2.9 3.0 3.1 3.1 2.8 2.7 2.7 2.7 2.7 2.7 2.6 2.6 2.8 2.7 2.3 2.3 2.3 2.3 2.3 2.3 2.4 2.3 2.4 2.3 500 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Treatment Phase PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 19 20 21 22 23 24 25 26 27 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: MALE 1 - 0 MG/KG/DAY I05508 I05517 I05519 I05520 I05526 I05527 3.4 3.4 3.4 3.4 3.4 3.4 3.6 3.6 3.6 3.4 3.4 3.3 3.3 3.3 3.4 3.4 3.3 3.3 3.3 3.2 3.2 3.2 3.3 3.3 3.4 3.4 3.4 3.1 3.0 3.1 3.1 3.1 3.0 3.2 3.2 3.1 3.7 3.7 3.7 3.8 3.7 3.7 3.8 3.9 3.8 4.5 4.5 4.6 4.6 4.7 4.8 4.9 5.0 5.0 GROUP: MALE 2 - 0.03 MG/KG/DAY I05514 I05515 I05516 I05521 3.6 3.6 3.6 3.6 3.7 3.7 3.8 3.8 3.8 3.8 3.8 3.6 3.7 3.7 3.7 3.8 3.8 3.7 3.2 3.2 3.2 3.3 3.3 3.3 3.4 3.4 3.4 4.6 4.6 4.7 4.6 4.6 4.7 4.7 4.7 4.7 GROUP: MALE 3 - 0.15 MG/KG/DAY I05505 I05510 I05518 I05523 I05524 I05528 3.3 3.3 3.2 3.3 3.3 3.3 3.4 3.3 3.2 3.3 3.3 3.2 3.3 3.3 3.4 3.5 3.4 3.4 3.3 3.3 3.2 3.3 3.3 3.3 3.3 3.4 3.3 3.0 3.0 2.9 2.9 2.9 2.9 3.1 3.0 2.9 3.3 3.3 3.2 3.3 3.3 3.3 3.4 3.4 3.3 3.6 3.7 3.7 3.7 3.7 3.7 3.7 3.6 3.7 GROUP: MALE 4 - 0.75 MG/KG/DAY I05506 I05507 I05509 I05511 I05512 I05522 4.0 4.0 3.9 3.9 3.9 4.0 4.0 3.9 4.5 4.4 4.3 4.2 4.2 4.1 4.2 4.2 4.2 3.0 3.1 2.9 3.0 2.8 2.9 2.8 2.6 2.7 2.7 2.8 2.7 2.6 2.5 2.6 2.5 2.6 2.8 2.7 2.6 2.7 2.7 2.5 3.7 3.6 3.6 3.6 3.6 3.6 3.7 3.7 3.5 501 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Treatment Phase PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 19 20 21 22 23 24 25 26 27 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: FEMALE 1 - 0 MG/KG/DAY I05529 I05530 I05531 I05535 I05544 I05549 2.5 2.5 2.5 2.5 2.5 2.6 2.5 2.5 2.4 3.0 3.0 2.9 3.0 3.0 3.0 3.1 3.0 3.0 2.8 2.8 2.7 2.8 2.7 2.7 2.8 2.8 2.9 3.5 3.5 3.5 3.6 3.4 3.5 3.6 3.6 3.5 2.8 2.8 2.8 2.8 2.8 2.8 2.9 2.9 2.9 3.1 3.1 3.0 3.1 3.0 3.0 3.0 3.1 3.0 GROUP: FEMALE 2 - 0.03 MG/KG/DAY I05537 I05541 I05547 I05550 4.2 4.2 4.2 4.2 4.2 4.3 4.4 4.4 4.3 2.7 2.7 2.6 2.7 2.8 2.7 2.8 2.8 2.8 3.1 3.0 3.0 2.9 2.8 2.7 2.8 2.7 2.8 3.0 3.0 2.9 3.0 2.9 3.0 3.1 3.0 3.0 GROUP: FEMALE 3 - 0.15 MG/KG/DAY I05532 I05538 I05539 I05545 I05548 I05552 2.8 2.8 2.7 2.8 2.8 2.8 2.8 2.8 2.7 3.4 3.4 3.3 3.5 3.5 3.4 3.5 3.4 3.5 4.0 4.0 3.8 3.8 3.8 3.9 3.9 3.9 3.9 2.7 2.8 2.6 2.7 2.6 2.7 2.7 2.7 2.7 3.1 3.1 3.0 3.1 3.1 3.1 3.1 3.1 3.1 2.8 2.8 2.7 2.8 2.8 2.8 2.9 2.8 2.7 GROUP: FEMALE 4 - 0.75 MG/KG/DAY I05533 I05534 I05536 I05540 I05542 I05551 2.6 2.6 2.6 2.6 2.6 2.7 2.7 2.7 2.5 2.9 2.8 2.7 2.9 2.8 2.9 2.8 2.7 2.8 3.5 3.5 3.3 3.3 3.4 3.3 3.3 3.4 3.4 3.1 3.0 3.0 2.9 2.9 3.0 3.0 3.0 3.0 2.7 2.7 2.6 2.7 2.6 2.6 2.7 2.6 2.6 2.4 2.4 2.4 2.4 2.4 2.4 2.4 2.4 2.4 502 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Recovery PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 28 29 30 31 32 33 34 35 36 37 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: MALE 1 - 0 MG/KG/DAY I05520 I05526 3.2 3.3 3.3 3.4 3.5 3.5 3.5 3.5 3.5 3.6 3.8 3.9 3.9 4.0 4.1 4.1 4.1 4.0 4.1 4.2 GROUP: MALE 3 - 0.15 MG/KG/DAY I05505 I05523 3.2 3.3 3.2 3.3 3.4 3.4 3.3 3.3 3.4 3.4 2.9 2.9 2.8 2.8 2.9 3.0 3.0 2.9 3.1 3.0 GROUP: MALE 4 - 0.75 MG/KG/DAY I05511 I05522 2.7 2.8 2.9 3.0 3.0 3.1 3.1 3.0 3.1 3.1 3.5 3.7 3.7 4.0 4.2 4.2 4.5 4.4 4.6 4.6 GROUP: FEMALE 1 - 0 MG/KG/DAY I05529 I05549 2.4 2.4 2.4 2.4 2.5 2.5 2.5 2.5 2.5 2.5 2.9 3.0 2.9 3.0 3.0 3.1 3.0 3.0 3.0 3.1 GROUP: FEMALE 3 - 0.15 MG/KG/DAY I05539 I05552 3.8 3.9 3.8 3.9 4.0 4.0 4.0 4.1 4.2 4.1 2.8 2.9 2.8 2.8 2.9 2.9 2.8 2.8 2.9 3.0 GROUP: FEMALE 4 - 0.75 MG/KG/DAY I05533 I05542 2.5 2.6 2.6 2.6 2.7 2.8 2.8 2.8 2.8 2.8 2.7 2.8 2.8 2.9 3.2 3.2 3.2 3.1 3.3 3.3 503 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Recovery PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 38 39 40 41 42 43 44 45 46 47 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: MALE 1 - 0 MG/KG/DAY I05520 3.6 3.6 3.6 3.7 3.8 3.8 4.0 4.1 4.2 4.1 I05526 4.2 4.1 4.1 4.3 4.2 4.2 4.4 4.4 4.5 4.3 GROUP: MALE 3 - 0.15 MG/KG/DAY I05505 I05523 3.3 3.3 3.3 3.4 3.3 3.3 3.4 3.5 3.5 3.4 3.0 2.9 2.9 3.1 3.0 3.0 3.1 3.1 3.1 3.0 GROUP: MALE 4 - 0.75 MG/KG/DAY I05511 I05522 3.1 3.0 2.9 3.1 3.0 3.1 3.2 3.2 3.3 3.2 4.5 4.4 4.4 4.5 4.5 4.5 4.5 4.5 4.6 4.4 GROUP: FEMALE 1 - 0 MG/KG/DAY I05529 I05549 2.5 2.4 2.3 2.5 2.4 2.4 2.5 2.5 2.5 2.4 3.0 3.0 2.9 3.1 3.0 3.0 3.0 3.1 3.1 3.0 GROUP: FEMALE 3 - 0.15 MG/KG/DAY I05539 I05552 4.1 4.1 4.0 4.2 4.1 4.1 4.3 4.2 4.2 4.2 2.9 2.9 2.8 3.0 3.0 3.0 3.0 3.1 3.0 2.9 GROUP: FEMALE 4 - 0.75 MG/KG/DAY I05533 I05542 2.7 2.7 2.8 2.8 2.7 2.7 2.8 2.8 2.8 2.7 3.3 3.2 3.1 3.3 3.2 3.3 3.3 3.3 3.4 3.4 504 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Recovery PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 48 49 50 51 52 53 54 55 56 57 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: MALE 1 - 0 MG/KG/DAY I05520 4.1 4.1 4.1 4.1 4.2 4.2 4.2 4.3 4.2 4.1 I05526 4.3 4.4 4.4 4.4 4.5 4.5 4.6 4.7 4.7 4.6 GROUP: MALE 3 - 0.15 MG/KG/DAY: I05505 I05523 3.4 3.4 3.4 3.4 3.4 3.4 3.4 3.4 3.4 3.4 3.0 3.1 3.0 3.1 3.1 3.0 3.1 3.1 3.2 3.1 GROUP: MALE 4 - 0.75 MG/KG/DAY: I05511 I05522 3.3 3.5 3.5 3.6 3.7 3.7 3.8 3.8 3.9 3.8 4.4 4.6 4.5 4.5 4.5 4.4 4.5 4.4 4.4 4.2 GROUP: FEMALE 1 - 0 MG/KG/DAY: I05529 I05549 2.3 2.5 2.4 2.4 2.5 2.4 2.4 2.4 2.4 2.3 2.8 3.0 2.9 3.0 2.9 2.8 2.8 2.9 2.9 2.8 GROUP: FEMALE 3 - 0.15 MG/KG/DAY: I05539 I05552 4.3 4.3 4.2 4.3 4.3 4.3 4.2 4.2 4.2 4.2 2.9 3.0 2.9 3.0 3.0 2.9 2.9 2.8 2.9 2.9 GROUP: FEMALE 4 - 0.75 MG/KG/DAY: I05533 I05542 2.7 2.9 2.8 2.8 2.8 2.7 2.7 2.6 2.7 2.6 3.4 3.4 3.3 3.3 3.4 3.4 3.4 3.5 3.5 3.4 505 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Recovery PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 58 59 60 61 62 63 64 65 66 67 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: MALE 1 - 0 MG/KG/DAY I05520 I05526 4.2 4.1 4.2 4.2 4.1 4.1 4.0 4.0 4.0 4.1 4.7 4.7 4.9 4.9 4.8 4.9 4.9 4.8 4.9 4.9 GROUP: MALE 3 - 0.15 MG/KG/DAY: I05505 I05523 3.4 3.4 3.5 3.5 3.6 3.5 3.5 3.4 3.4 3.5 3.2 3.2 3.3 3.3 3.3 3.3 3.3 3.3 3.2 3.3 GROUP: MALE 4 - 0.75 MG/KG/DAY: I05511 I05522 3.9 3.8 4.0 4.0 4.0 4.1 4.3 4.2 4.1 4.2 4.4 4.4 4.6 4.6 4.7 4.7 4.6 4.5 4.5 4.5 GROUP: FEMALE 1 - 0 MG/KG/DAY: I05529 I05549 2.5 2.4 2.5 2.5 2.4 2.5 2.4 2.4 2.4 2.4 2.9 2.9 3.0 2.9 3.0 3.0 2.9 2.9 2.8 2.9 GROUP: FEMALE 3 - 0.15 MG/KG/DAY: I05539 I05552 4.1 4.0 4.2 4.1 4.1 4.1 4.1 4.0 4.0 4.1 3.0 3.0 3.0 3.0 3.0 3.1 3.0 2.9 2.9 3.1 GROUP: FEMALE 4 - 0.75 MG/KG/DAY: I05533 I05542 2.6 2.6 2.8 2.8 2.8 2.8 2.7 2.7 2.7 2.8 3.4 3.4 3.5 3.5 3.6 3.6 3.6 3.5 3.5 3.6 506 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Recovery PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 68 69 70 71 72 73 74 75 76 77 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: MALE 1 - 0 MG/KG/DAY I05520 4.2 4.3 4.2 4.2 4.3 4.2 4.2 4.2 4.2 4.1 I05526 5.0 5.1 5.0 5.1 5.3 5.2 5.4 5.3 5.4 5.3 GROUP: MALE 3 - 0.15 MG/KG/DAY: I05505 I05523 3.6 3.6 3.5 3.5 3.6 3.5 3.6 3.6 3.6 3.5 3.3 3.4 3.4 3.4 3.5 3.4 3.5 3.5 3.5 3.4 GROUP: MALE 4 - 0.75 MG/KG/DAY: I05511 I05522 4.3 4.3 4.3 4.2 4.3 4.2 4.3 4.3 4.3 4.3 4.6 4.7 4.6 4.6 4.6 4.5 4.6 4.6 4.6 4.5 GROUP: FEMALE 1 - 0 MG/KG/DAY: I05529 I05549 2.4 2.5 2.4 2.4 2.4 2.4 2.4 2.5 2.5 2.4 2.9 2.9 2.9 2.9 2.9 2.9 3.0 2.9 2.9 2.9 GROUP: FEMALE 3 - 0.15 MG/KG/DAY: I05539 I05552 4.1 4.2 4.1 4.2 4.2 4.2 4.2 4.2 4.2 4.2 3.0 3.0 3.0 3.0 3.1 3.0 3.1 3.1 3.2 3.1 GROUP: FEMALE 4 - 0.75 MG/KG/DAY: I05533 I05542 2.7 2.7 2.7 2.7 2.7 2.6 2.7 2.7 2.8 2.7 3.6 3.7 3.7 3.7 3.8 3.7 3.8 3.8 3.9 3.8 507 Appendix 3 Covance 6329-223 3M T-6295.7 Individual Body Weight Data (kg) Recovery PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK NUMBER 78 79 80 ------------------------------------------------------------------------------------------------------------------------------------ GROUP: I05520 I05526 MALE 1 - 0 MG/KG/DAY 4.0 4.0 5.3 5.3 GROUP: MALE 3 - 0.15 MG/KG/DAY I05505 I05523 3.5 3.5 3.5 3.4 3.5 3.2 GROUP: MALE 4 - 0.75 MG/KG/DAY I05511 I05522 4.3 4.4 4.5 4.5 GROUP: FEMALE 1 - 0 MG/KG/DAY I05529 I05549 2.4 2.4 2.8 2.9 GROUP: FEMALE 3 - 0.15 MG/KG/DAY I05539 I05552 4.1 4.2 4.0 2.9 3.0 2.8 GROUP: FEMALE 4 - 0.75 MG/KG/DAY I05533 I05542 2.6 2.7 3.8 3.9 508 Sponsor: 3M St. Paul, Minnesota FINAL REPORT Study Title: 26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys Author: Peter J. Thomford, PhD Study Completion Date: January 11, 2002 Testing Facility: Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Laboratory Study Identification: Covance 6329-223 Sponsor Study Identification: 3M Study No. T-6295.7 Volume II of II Page 509 of 1086 Covance 6329-223 3M T-6295.7 VOLUME II OF II CONTENTS Page APPENDIX 4.............................................................................................................. 511 Individual Clinical Hematology Data....................................................................... 512 Individual Clinical Chemistry Data.......................................................................... 614 Individual Clinical Urinalysis Data.......................................................................... 728 APPENDIX 5.............................................................................................................. 818 Individual Palmitoyl CoA Oxidase Determinations.................................................. 819 Individual Anatomic Pathology Data ....................................................................... 823 APPENDIX 6.............................................................................................................. 907 AniLytics Inc. Quality Assurance Statements .......................................................... 908 Summary and Individual Blood Hormone Determination......................................... 917 APPENDIX 7.............................................................................................................. 963 Cell Proliferation Report ......................................................................................... 964 APPENDIX 8.............................................................................................................. 977 Electron Microscopic Evaluation of Liver in Cynomolgus Monkeys........................ 978 APPENDIX 9............................................................................................................ 1069 Urobilinogen Analysis Report ............................................................................... 1070 APPENDIX 10.......................................................................................................... 1072 Dose Confirmation Analysis Report ...................................................................... 1073 Compound Stability Report ................................................................................... 1078 Analytical Laboratory Report ................................................................................ 1080 Certificate of Analysis ........................................................................................... 1083 Quality Assurance Statement ................................................................................. 1086 510 APPENDIX 4 Individual Clinical Hematology Data Individual Clinical Chemistry Data Individual Clinical Urinalysis Data Covance 6329-223 3M T-6295.7 511 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.48 12.3 40.3 62.2 19.0 30.5 419 .3 19 6.25 12.8 42.4 67.8 20.5 30.2 380 .5 31 6.97 12.5 42.9 61.5 17.9 29.0 577 .5 35 6.27 11.8 39.4 62.9 18.8 29.9 681 .0 0 6.48 12.0 41.1 63.5 18.6 29.3 472 .2 13 6.27 12.1 40.9 65.3 19.3 29.6 652 .3 19 6.45 12.2 41.2 63.9 19.0 29.8 530 .3 .275 .36 1.30 2.32 .87 .56 125.0 .19 6 6 6 6 6 6 6 6 20 12.6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 7.28 12.5 45.5 62.5 17.2 27.5 469 .5 36 6.22 11.8 39.8 64.0 18.9 29.6 675 .6 37 6.67 12.5 40.9 61.3 18.7 30.6 341 .1 7 7.79 12.9 45.3 58.1 16.6 28.5 813 .2 16 6.99 12.4 42.9 61.5 17.8 29.0 574 .4 .688 .46 2.95 2.51 1.13 1.34 210.3 .24 4 4 4 4 4 4 4 4 24 14.9 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.45 12.6 42.0 65.2 19.6 30.0 469 1.4 90 6.58 11.9 39.7 60.3 18.1 29.9 546 .5 33 7.36 13.0 44.8 60.9 17.6 29.0 375 .7 52 6.73 12.8 43.1 64.1 19.0 29.7 569 .0 0 6.76 13.0 44.6 66.1 19.3 29.2 635 .0 0 6.67 12.6 43.1 64.6 18.9 29.3 366 .3 20 6.76 12.6 42.9 63.5 18.7 29.5 493 .5 .315 .41 1.88 2.38 .76 .41 109.0 .53 6 6 6 6 6 6 6 6 32 34.5 6 512 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 7.63 13.4 45.8 60.0 17.6 29.3 519 .6 46 6.94 12.0 41.5 59.7 17.3 28.9 58 .3 21 6.89 11.9 42.3 61.4 17.3 28.1 409 .4 28 5.90 11.4 40.3 68.4 19.4 28.4 528 1.4 83 7.20 13.1 44.5 61.8 18.1 29.3 342 .2 14 6.73 13.1 44.1 65.5 19.5 29.7 636 .1 7 6.88 12.5 43.1 62.8 18.2 29.0 415 .5 .575 .82 2.06 3.44 1.01 .61 202.6 .47 6 6 6 6 6 6 6 6 33 27.8 6 513 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.6 2.1 4.0 .4 .0 .0 32 61 6 0 0 9.2 3.3 4.7 1.0 .1 .1 36 52 11 1 1 6.7 3.1 3.1 .4 .2 .0 46 46 5 2 0 9.0 5.1 3.0 .8 .0 .1 56 34 9 0 1 11.3 5.4 5.3 .5 .1 .0 48 47 5 1 0 8.9 4.4 3.7 .7 .1 .0 49 41 8 1 0 8.6 3.9 4.0 .6 .1 .0 44 47 7 1 0 1.76 1.28 .90 .24 .08 .05 8.9 9.2 2.4 .8 .5 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 11.7 7.2 4.0 .4 .2 .0 62 34 3 2 0 11.5 3.2 6.2 1.5 .5 .0 28 54 13 4 0 9.5 4.0 4.4 .9 .1 .0 42 47 10 1 0 11.1 6.3 4.0 .6 .2 .0 56 36 6 2 0 11.0 5.2 4.6 .8 .2 .0 47 43 8 2 0 1.00 1.88 1.05 .48 .17 .00 15.2 9.4 4.4 1.3 .0 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 12.5 9.4 2.4 .6 .1 .0 75 19 5 1 0 11.1 5.8 4.2 1.0 .1 .0 52 38 9 1 0 10.7 4.8 4.6 1.3 .0 .0 45 43 12 0 0 15.0 9.8 3.7 .8 .6 .0 66 25 5 4 0 9.4 4.2 4.0 1.1 .0 .1 45 42 12 0 1 12.7 5.3 5.9 .8 .7 .0 42 46 6 5 0 11.9 6.6 4.1 .9 .2 .0 54 36 8 2 0 1.95 2.42 1.14 .25 .31 .04 13.4 10.9 3.3 2.1 .4 6 6 6 6 6 6 6 6 6 6 6 514 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 9.3 3.0 5.0 1.1 .2 .1 32 54 12 2 1 13.7 4.9 6.3 2.1 .1 .2 36 46 15 1 2 7.5 3.3 2.8 .7 .7 .0 44 37 9 9 0 8.0 3.9 3.3 .6 .1 .0 49 41 8 1 0 7.1 1.6 4.3 1.2 .0 .0 22 60 16 0 1 11.0 5.5 4.1 1.1 .2 .1 50 37 10 2 1 9.4 3.7 4.3 1.1 .2 .1 39 46 12 2 1 2.53 1.40 1.25 .53 .25 .08 10.9 9.5 3.3 3.3 .8 6 6 6 6 6 6 6 6 6 6 6 515 Appendix 4 Individual Clinical Hematology Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 - - - - - I05517 - - - - - I05519 - - - - - I05520 - - - - - I05526 - - - - - I05527 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 - - - - - I05515 - - - - - I05516 - - - - - I05521 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05510 - - - - - I05518 - - - - - I05523 - - - - - I05524 - - - - - I05528 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 - - - - - I05507 - - - - - I05509 - - - - - I05511 - - - - - I05512 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 516 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.96 11.5 37.1 62.2 19.3 31.0 631 .4 24 6.78 13.3 45.0 66.4 19.6 29.5 552 .3 20 5.72 10.5 34.7 60.6 18.3 30.2 584 .1 6 6.66 12.2 40.8 61.3 18.3 29.9 577 .5 33 4.98 11.6 36.2 72.7 23.2 31.9 471 1.3 65 6.45 12.6 41.9 65.0 19.5 30.1 417 1.0 64 6.09 12.0 39.3 64.7 19.7 30.4 539 .6 .681 .97 3.93 4.51 1.81 .87 79.5 .46 6 6 6 6 6 6 6 6 35 24.2 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.13 10.6 36.7 59.9 17.3 28.8 529 .3 18 5.78 12.0 40.0 69.1 20.8 30.2 426 .9 52 6.30 10.7 37.4 59.3 17.0 28.6 558 .4 25 7.02 12.8 43.9 62.5 18.2 29.1 414 .2 14 6.31 11.5 39.5 62.7 18.3 29.2 482 .4 .522 1.06 3.26 4.49 1.73 .71 72.4 .31 4 4 4 4 4 4 4 4 27 17.1 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.95 12.7 43.2 62.2 18.2 29.3 433 .4 28 6.16 11.3 38.3 62.1 18.4 29.6 475 .3 18 6.23 11.7 39.2 62.9 18.8 29.9 477 .8 50 6.72 12.3 40.7 60.6 18.3 30.1 325 .1 7 6.76 11.8 38.0 56.2 17.4 31.0 615 .4 27 6.39 12.0 41.1 64.2 18.7 29.1 560 .7 45 6.54 12.0 40.1 61.4 18.3 29.8 481 .4 .320 .49 1.97 2.79 .50 .68 100.9 .26 6 6 6 6 6 6 6 6 29 16.2 6 517 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 6.46 12.1 41.2 63.8 18.7 29.3 337 .2 13 6.72 13.1 44.2 65.8 19.5 29.6 438 .4 27 6.67 12.1 41.7 62.6 18.2 29.1 606 .1 7 6.21 11.8 39.6 63.8 19.0 29.8 433 .0 0 6.57 12.0 42.4 64.5 18.2 28.3 492 .4 26 6.35 11.7 40.0 63.0 18.5 29.4 304 .4 25 6.50 12.1 41.5 63.9 18.7 29.2 435 .2 .195 .50 1.68 1.14 .50 .52 108.9 .18 6 6 6 6 6 6 6 6 16 11.4 6 518 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 7.4 3.4 3.3 .6 .2 .0 45 45 8 2 0 11.7 6.0 4.9 .7 .1 .0 51 42 6 1 0 8.4 5.0 2.6 .7 .1 .1 59 31 8 1 1 12.6 5.0 6.0 .8 .6 .1 39 48 7 5 1 13.0 5.3 5.8 1.2 .7 .0 40 44 9 6 0 8.0 3.1 4.3 .5 .1 .0 38 54 6 2 0 10.2 4.6 4.5 .8 .3 .0 45 44 7 3 0 2.52 1.14 1.36 .24 .28 .05 8.3 7.6 1.2 2.1 .5 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 12.2 8.6 2.7 .6 .2 .0 70 22 5 2 0 8.1 3.0 4.1 .9 .1 .1 36 50 11 1 1 6.8 3.6 2.5 .6 .1 .0 53 36 9 2 0 7.6 4.6 2.4 .5 .1 .0 60 32 6 1 0 8.7 5.0 2.9 .6 .1 .0 55 35 8 2 0 2.41 2.52 .79 .17 .05 .05 14.3 11.6 2.8 .6 .5 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 7.6 2.6 3.6 1.2 .2 .0 35 48 15 2 0 12.0 7.4 3.7 .7 .2 .0 62 31 6 2 0 7.1 2.6 3.5 .9 .2 .0 36 49 12 2 0 14.4 9.4 4.2 .7 .0 .0 65 29 5 0 0 11.3 5.4 4.4 .8 .7 .0 48 39 7 6 0 8.0 3.3 3.4 .7 .6 .1 41 42 9 8 1 10.1 5.1 3.8 .8 .3 .0 48 40 9 3 0 2.94 2.81 .40 .20 .27 .04 13.0 8.4 3.8 3.0 .4 6 6 6 6 6 6 6 6 6 6 6 519 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 10.0 4.1 5.1 .7 .0 .0 41 51 7 0 0 13.3 6.9 5.2 .7 .4 .0 52 39 6 3 0 9.6 4.4 3.5 1.3 .3 .1 46 36 14 3 1 8.9 5.4 2.4 .9 .1 .0 61 27 10 1 0 8.3 5.9 2.0 .4 .0 .0 71 24 4 0 0 3.8 2.0 1.2 .5 .0 .0 53 32 14 1 0 9.0 4.8 3.2 .8 .1 .0 54 35 9 1 0 3.08 1.70 1.66 .32 .18 .04 10.7 9.7 4.2 1.4 .4 6 6 6 6 6 6 6 6 6 6 6 520 Appendix 4 Individual Clinical Hematology Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05530 - - - - - I05531 - - - - - I05535 - - - - - I05544 - - - - - I05549 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 - - - - - I05541 - - - - - I05547 - - - - - I05550 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 - - - - - I05538 - - - - - I05539 - - - - - I05545 - - - - - I05548 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05534 - - - - - I05536 - - - - - I05540 - - - - - I05542 - - - - - I05551 - - - - - Covance 6329-223 3M T-6295.7 521 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.53 13.0 41.4 63.4 19.9 31.4 369 .1 7 6.32 13.0 42.7 67.5 20.5 30.4 443 .2 13 6.83 12.2 40.9 59.8 17.8 29.8 474 .3 20 6.50 12.1 39.5 60.7 18.6 30.7 644 .1 6 6.20 11.6 38.6 62.3 18.7 30.0 375 .1 6 6.34 12.2 40.6 64.0 19.3 30.1 614 .5 32 6.45 12.4 40.6 63.0 19.1 30.4 486 .2 .221 .55 1.44 2.74 .97 .58 117.8 .16 6 6 6 6 6 6 6 6 14 10.4 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 7.32 13.0 47.9 65.5 17.8 27.2 492 .6 44 6.51 12.5 42.5 65.2 19.2 29.4 629 .8 52 6.35 12.2 39.0 61.4 19.2 31.2 344 .3 19 7.26 12.2 40.3 55.6 16.8 30.1 665 .0 0 6.86 12.5 42.4 61.9 18.2 29.5 532 .4 .501 .38 3.93 4.61 1.17 1.69 146.1 .35 4 4 4 4 4 4 4 4 29 23.8 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.34 12.8 41.3 65.1 20.3 31.1 421 .3 19 6.99 12.3 41.5 59.3 17.6 29.7 483 .4 28 7.20 12.7 42.1 58.5 17.7 30.2 498 .6 43 6.78 12.6 41.3 60.9 18.5 30.5 544 .4 27 6.31 12.3 41.4 65.6 19.5 29.7 519 .2 13 6.34 12.1 39.8 62.7 19.1 30.4 388 .3 19 6.66 12.5 41.2 62.0 18.8 30.3 476 .4 .385 .27 .76 2.96 1.06 .53 59.6 .14 6 6 6 6 6 6 6 6 25 10.5 6 522 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 7.03 12.3 41.0 58.3 17.4 29.9 459 .3 21 6.57 11.4 39.6 60.2 17.3 28.7 69 PA .3 20 6.84 12.1 41.9 61.3 17.6 28.8 399 .3 21 5.80 10.9 37.1 63.9 18.8 29.5 490 .4 23 6.60 12.1 40.3 61.0 18.3 30.1 362 .5 33 6.32 12.3 41.5 65.6 19.4 29.6 519 .5 32 6.53 11.8 40.2 61.7 18.1 29.4 383 .4 .431 .57 1.74 2.63 .85 .57 164.3 .10 6 6 6 6 6 6 6 6 25 5.9 6 523 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.2 1.8 2.9 .4 .0 .0 34 57 9 1 0 7.8 2.5 4.2 .9 .0 .2 32 53 12 0 2 7.1 3.5 3.4 .2 .1 .0 49 48 3 1 0 6.8 3.5 2.9 .4 .0 .0 52 43 5 0 0 7.5 4.7 2.2 .3 .2 .0 63 30 4 3 0 11.2 7.5 2.8 .9 .0 .0 67 25 8 0 0 7.6 3.9 3.1 .5 .0 .0 50 43 7 1 0 1.98 2.01 .67 .31 .08 .08 14.4 12.8 3.4 1.2 .8 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 11.9 5.9 5.3 .5 .2 .0 50 44 4 2 0 8.0 3.1 4.1 .6 .2 .0 39 51 7 2 0 12.1 8.2 3.1 .7 .2 .0 67 25 5 2 0 11.0 8.1 2.4 .3 .1 .0 74 22 3 1 0 10.8 6.3 3.7 .5 .2 .0 58 36 5 2 0 1.89 2.40 1.26 .17 .05 .00 15.9 14.2 1.7 .5 .0 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 11.7 9.3 2.0 .2 .3 .0 79 17 2 2 0 8.8 5.1 2.9 .7 .0 .0 58 32 8 1 0 9.4 3.9 4.6 .8 .0 .0 42 49 8 0 0 11.1 7.0 3.6 .4 .1 .0 63 32 4 1 0 6.9 3.5 2.6 .8 .0 .1 50 37 12 0 1 12.4 7.2 3.6 .7 .8 .1 58 30 5 6 0 10.0 6.0 3.2 .6 .2 .0 58 33 6 2 0 2.06 2.23 .91 .24 .32 .05 12.5 10.4 3.6 2.3 .4 6 6 6 6 6 6 6 6 6 6 6 524 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 7.1 3.4 2.9 .7 .1 .0 48 41 9 1 1 17.9 13.3 3.8 .7 .1 .1 74 21 4 0 1 11.6 8.0 2.8 .4 .3 .0 69 24 4 3 0 8.5 5.5 2.4 .5 .1 .1 65 28 6 1 1 6.6 3.5 2.4 .7 .0 .0 53 36 10 0 1 10.2 6.2 3.0 .9 .0 .1 61 30 9 0 1 10.3 6.6 2.9 .6 .1 .0 62 30 7 1 1 4.16 3.69 .52 .18 .11 .05 9.8 7.5 2.7 1.2 .4 6 6 6 6 6 6 6 6 6 6 6 525 Appendix 4 Individual Clinical Hematology Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 - - - - - I05517 - - - - - I05519 - - - - - I05520 - - - - - I05526 - - - - - I05527 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 - - - - - I05515 - - - - - I05516 - - - - - I05521 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05510 - - - - - I05518 - - - - - I05523 - - - - - I05524 - - - - - I05528 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 - - - - - I05507 - - - - - I05509 - - - - - I05511 - - - - - I05512 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 526 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.43 12.3 40.4 62.8 19.1 30.5 647 .3 19 6.51 12.7 42.1 64.7 19.6 30.2 629 .5 33 6.37 11.6 38.8 60.8 18.1 29.8 439 .2 13 6.52 11.8 39.1 60.0 18.0 30.0 538 .1 7 5.78 11.6 37.9 65.6 20.0 30.5 499 .4 23 6.85 13.3 44.4 64.8 19.5 30.0 475 .5 34 6.41 12.2 40.5 63.1 19.0 30.2 538 .3 .351 .69 2.42 2.31 .83 .29 84.2 .16 6 6 6 6 6 6 6 6 22 10.8 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.60 10.9 38.1 57.8 16.6 28.7 448 .3 20 5.70 11.7 40.5 70.9 20.6 29.0 391 .7 40 6.79 11.6 39.0 57.4 17.0 29.7 417 .1 7 7.29 13.2 44.7 61.3 18.1 29.6 411 .1 7 6.60 11.8 40.6 61.8 18.1 29.2 417 .3 .664 .97 2.92 6.28 1.80 .48 23.6 .28 4 4 4 4 4 4 4 4 18 15.6 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.43 11.9 39.5 61.3 18.5 30.1 451 .4 26 6.40 11.3 38.4 60.1 17.7 29.5 398 .4 26 6.35 12.0 40.6 63.8 18.9 29.5 406 .1 6 6.85 12.4 41.2 60.1 18.1 30.1 300 .3 21 7.09 11.9 39.8 56.1 16.8 29.8 553 .3 21 6.19 11.4 38.8 62.7 18.5 29.5 478 .2 12 6.55 11.8 39.7 60.7 18.1 29.7 431 .3 .343 .41 1.06 2.68 .75 .29 85.3 .12 6 6 6 6 6 6 6 6 19 8.0 6 527 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 6.04 11.6 38.0 62.8 19.1 30.5 345 .3 18 5.91 11.3 38.4 65.0 19.2 29.5 532 .7 41 6.43 11.7 41.3 64.2 18.3 28.4 531 .2 13 6.09 11.4 37.1 60.9 18.7 30.8 501 .1 6 6.66 12.2 41.8 62.8 18.3 29.2 555 .2 13 6.12 11.1 37.9 62.0 18.2 29.3 351 .5 31 6.21 11.6 39.1 63.0 18.6 29.6 469 .3 .280 .38 1.96 1.48 .44 .89 95.4 .23 6 6 6 6 6 6 6 6 20 13.1 6 528 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 9.6 6.2 2.8 .5 .1 .0 65 30 5 1 0 12.1 8.3 2.8 1.0 .0 .0 68 23 8 0 0 14.6 11.7 1.9 .9 .1 .1 80 13 6 1 0 21.4 12.2 5.9 2.4 .7 .2 57 28 11 3 1 8.6 2.3 5.2 .7 .3 .0 26 61 8 4 1 10.1 5.9 2.8 1.0 .4 .0 58 28 10 4 0 12.7 7.8 3.6 1.1 .3 .0 59 30 8 2 0 4.75 3.77 1.59 .67 .26 .08 18.2 16.2 2.3 1.7 .5 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 7.7 3.5 2.8 .8 .5 .1 46 36 10 6 2 11.5 6.5 3.7 1.1 .2 .0 56 32 10 2 0 7.3 5.0 1.7 .5 .1 .0 68 24 7 1 0 11.7 7.9 2.8 .8 .2 .0 68 24 6 2 0 9.6 5.7 2.8 .8 .2 .0 60 29 8 3 0 2.37 1.90 .82 .24 .17 .05 10.6 6.0 2.1 2.2 1.0 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 8.0 5.4 2.0 .4 .1 .0 68 25 5 2 0 9.4 5.1 3.4 .6 .3 .0 54 36 6 3 0 4.4 1.2 2.8 .4 .1 .0 26 63 8 2 0 10.0 5.2 3.9 .7 .1 .0 52 39 7 1 0 11.7 7.7 3.0 .5 .4 .0 66 26 4 4 0 11.2 8.2 2.2 .4 .5 .0 73 19 4 4 0 9.1 5.5 2.9 .5 .2 .0 56 35 6 3 0 2.66 2.48 .72 .13 .18 .00 17.0 15.7 1.6 1.2 .0 6 6 6 6 6 6 6 6 6 6 6 529 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 8.8 3.9 4.4 .4 .0 .0 45 50 5 0 0 8.8 4.6 3.0 .9 .2 .0 52 34 11 3 1 7.6 4.8 2.0 .6 .1 .0 63 27 8 2 0 9.7 5.0 3.9 .6 .1 .0 51 40 7 1 0 13.7 11.5 1.8 .4 .0 .0 84 13 3 0 0 5.0 2.2 2.3 .4 .1 .0 44 47 7 2 0 8.9 5.3 2.9 .6 .1 .0 56 35 7 1 0 2.85 3.19 1.06 .20 .08 .00 15.1 13.7 2.7 1.2 .4 6 6 6 6 6 6 6 6 6 6 6 530 Appendix 4 Individual Clinical Hematology Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05530 - - - - - I05531 - - - - - I05535 - - - - - I05544 - - - - - I05549 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 - - - - - I05541 - - - - - I05547 - - - - - I05550 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 - - - - - I05538 - - - - - I05539 - - - - - I05545 - - - - - I05548 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05534 - - - - - I05536 - - - - - I05540 - - - - - I05542 - - - - - I05551 - - - - - Covance 6329-223 3M T-6295.7 531 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.68 13.2 42.0 62.8 19.8 31.5 463 .1 7 6.29 12.9 42.8 68.0 20.4 30.1 423 .5 31 6.93 12.2 41.6 59.9 17.6 29.4 524 .3 21 6.53 12.4 39.9 61.1 18.9 31.0 699 .0 0 6.10 11.7 38.1 62.4 19.1 30.7 377 .1 6 6.43 12.5 42.3 65.8 19.4 29.5 644 .7 45 6.49 12.5 41.1 63.3 19.2 30.4 522 .3 .292 .53 1.78 3.03 .95 .84 126.9 .27 6 6 6 6 6 6 6 6 18 17.3 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.86 12.2 41.7 60.9 17.7 29.1 438 .1 7 6.61 12.6 42.3 63.9 19.1 29.9 647 1.0 66 6.44 12.0 39.4 61.1 18.7 30.6 376 .4 26 7.44 12.7 42.2 56.8 17.1 30.0 684 .0 0 6.84 12.4 41.4 60.7 18.2 29.9 536 .4 .437 .33 1.36 2.92 .91 .62 152.1 .45 4 4 4 4 4 4 4 4 25 29.6 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.47 13.0 41.6 64.2 20.1 31.3 450 .5 32 6.82 12.4 40.1 58.8 18.2 30.9 499 .5 34 7.10 12.7 41.5 58.5 17.8 30.5 578 .6 43 6.51 12.7 40.9 62.8 19.5 31.0 625 .1 7 6.54 12.6 42.1 64.3 19.3 30.0 520 .0 0 6.19 11.5 38.2 61.8 18.6 30.2 349 .2 12 6.60 12.5 40.7 61.7 18.9 30.6 504 .3 .315 .52 1.42 2.56 .87 .50 97.3 .25 6 6 6 6 6 6 6 6 21 17.3 6 532 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 7.46 13.1 43.4 58.2 17.6 30.2 534 .3 22 6.81 12.1 40.5 59.4 17.7 29.8 36 .1 7 6.69 11.9 40.0 59.8 17.7 29.6 480 .5 33 5.86 11.1 37.6 64.1 18.9 29.5 629 .4 23 6.90 12.8 41.6 60.3 18.5 30.7 359 .0 0 6.65 12.8 43.8 65.9 19.3 29.3 586 .4 27 6.73 12.3 41.2 61.3 18.3 29.8 437 .3 .516 .75 2.31 3.02 .72 .52 217.8 .19 6 6 6 6 6 6 6 6 19 12.6 6 533 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 7.4 3.7 3.3 .4 .0 .0 49 45 5 1 0 8.0 2.1 4.7 1.0 .1 .1 27 59 12 1 2 6.7 3.1 3.2 .4 .0 .0 46 48 5 1 0 8.0 3.8 3.4 .6 .1 .1 48 43 7 1 1 6.0 3.2 2.2 .5 .1 .0 52 36 9 2 0 7.8 2.4 4.2 .9 .2 .0 31 54 12 3 0 7.3 3.0 3.5 .6 .1 .0 42 48 8 2 0 .81 .68 .87 .26 .08 .05 10.5 8.2 3.2 .8 .8 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 8.1 5.0 2.3 .5 .2 .0 62 29 6 2 0 10.3 4.6 4.3 1.2 .2 .0 44 42 12 2 0 12.1 7.3 3.5 1.1 .1 .0 61 29 9 1 0 11.6 7.5 3.4 .5 .2 .0 65 29 4 2 0 10.5 6.1 3.4 .8 .2 .0 58 32 8 2 0 1.79 1.51 .82 .38 .05 .00 9.5 6.5 3.5 .5 .0 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 10.8 8.0 2.3 .2 .3 .0 73 21 2 3 0 13.3 8.7 3.7 .7 .1 .0 65 28 6 1 0 9.9 3.2 5.8 .8 .1 .0 32 59 8 1 0 12.7 7.7 4.5 .4 .1 .0 60 36 3 1 0 7.7 3.2 3.4 1.0 .1 .1 41 44 13 1 1 16.4 11.1 3.6 1.3 .4 .1 68 22 8 2 0 11.8 7.0 3.9 .7 .2 .0 56 35 7 2 0 3.02 3.16 1.18 .40 .13 .05 16.3 14.6 4.0 .8 .4 6 6 6 6 6 6 6 6 6 6 6 534 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 6.5 2.5 3.5 .4 .1 .0 38 54 6 1 0 14.6 9.6 3.6 1.0 .2 .2 66 24 7 2 1 10.6 6.4 2.8 .7 .6 .1 60 27 7 6 1 7.7 4.2 3.0 .4 .1 .0 54 39 5 1 0 7.7 3.6 3.5 .6 .0 .0 46 45 8 0 0 10.7 5.5 4.3 .7 .2 .0 51 40 6 2 0 9.6 5.3 3.4 .6 .2 .0 52 38 6 2 0 2.97 2.52 .52 .23 .21 .08 10.0 11.2 1.0 2.1 .5 6 6 6 6 6 6 6 6 6 6 6 535 Appendix 4 Individual Clinical Hematology Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 - - - - - I05517 - - - - - I05519 - - - - - I05520 - - - - - I05526 - - - - - I05527 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 - - - - - I05515 - - - - - I05516 - - - - - I05521 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05510 - - - - - I05518 - - - - - I05523 - - - - - I05524 - - - - - I05528 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 - - - - - I05507 - - - - - I05509 - - - - - I05511 - - - - - I05512 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 536 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.15 12.0 38.4 62.4 19.5 31.3 668 .5 31 5.93 12.1 39.7 66.8 20.3 30.4 515 .6 36 6.56 12.1 40.5 61.6 18.5 30.0 644 .1 7 7.02 12.7 42.4 60.4 18.2 30.0 600 .3 21 4.91 11.5 35.4 72.1 23.4 32.4 506 .7 34 6.83 13.4 44.9 65.8 19.6 29.8 501 .5 34 6.23 12.3 40.2 64.9 19.9 30.6 572 .4 .766 .66 3.27 4.33 1.87 1.01 74.6 .22 6 6 6 6 6 6 6 6 27 11.2 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.44 10.9 37.8 58.8 16.9 28.8 357 .3 19 5.67 12.2 40.5 71.3 21.4 30.1 507 .7 40 6.82 11.9 39.2 57.4 17.4 30.3 548 .8 55 7.01 12.9 43.4 62.0 18.4 29.7 437 .0 0 6.48 12.0 40.2 62.4 18.5 29.7 462 .4 .593 .83 2.39 6.25 2.02 .67 83.8 .37 4 4 4 4 4 4 4 4 28 24.1 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 9.13 17.2 55.9 61.2 18.8 30.8 306 .1 9 6.64 11.8 40.0 60.3 17.8 29.5 456 .6 40 6.45 12.5 40.4 62.6 19.3 30.9 374 .0 0 6.74 12.2 40.3 59.8 18.0 30.2 326 .7 47 6.80 11.7 38.4 56.4 17.2 30.4 667 .3 20 6.21 11.6 38.9 62.6 18.6 29.7 486 .5 31 7.00 12.8 42.3 60.5 18.3 30.3 436 .4 1.068 2.17 6.70 2.31 .76 .57 133.5 .28 6 6 6 6 6 6 6 6 24 18.2 6 537 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 6.04 11.7 39.0 64.6 19.3 29.9 355 .4 24 5.74 11.4 37.9 66.0 19.8 30.0 620 .5 29 6.72 12.2 42.6 63.5 18.2 28.7 622 .1 7 6.13 11.9 39.5 64.5 19.4 30.1 432 .6 37 6.75 12.1 42.6 63.0 18.0 28.5 665 .0 0 6.32 11.7 39.5 62.5 18.6 29.7 333 .1 6 6.28 11.8 40.2 64.0 18.9 29.5 504 .3 .397 .29 1.96 1.27 .72 .70 148.3 .25 6 6 6 6 6 6 6 6 17 14.9 6 538 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.8 2.9 2.2 .5 .1 .0 50 38 9 1 1 13.0 7.8 4.5 .5 .1 .0 60 35 4 1 0 14.1 9.9 3.0 .9 .2 .1 70 22 6 1 1 10.9 3.5 5.4 1.4 .5 .2 32 49 13 5 1 10.5 2.9 7.0 .0 .5 .0 27 67 0 5 0 12.4 7.9 3.7 .4 .3 .0 64 30 3 2 0 11.1 5.8 4.3 .6 .3 .0 50 40 6 2 0 2.93 3.08 1.73 .48 .18 .08 17.6 15.9 4.6 2.0 .5 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 10.6 5.7 3.4 .8 .5 .1 54 33 8 5 1 8.3 2.4 5.0 .6 .2 .1 29 61 8 2 1 7.2 3.7 2.7 .5 .2 .0 52 38 7 2 0 8.8 5.6 2.4 .7 .1 .0 63 27 8 1 0 8.7 4.4 3.4 .6 .2 .0 50 40 8 2 0 1.42 1.59 1.16 .13 .17 .06 14.5 14.9 .5 1.7 .6 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 8.9 5.7 2.3 .7 .1 .0 64 26 8 1 0 10.6 5.7 4.1 .4 .4 .0 54 39 4 4 0 6.1 2.2 3.1 .5 .2 .1 37 51 9 3 1 9.7 4.0 5.0 .5 .2 .0 41 51 5 2 0 7.1 2.3 3.7 .7 .3 .1 32 52 10 5 1 10.1 6.0 3.2 .3 .5 .0 60 32 3 5 0 8.8 4.3 3.6 .5 .3 .0 48 42 6 3 0 1.78 1.75 .93 .16 .15 .05 13.1 11.2 2.9 1.6 .5 6 6 6 6 6 6 6 6 6 6 6 539 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 8.4 3.2 4.8 .4 .0 .0 38 57 4 0 0 18.0 12.8 3.6 1.4 .2 .1 71 20 8 1 0 6.7 3.9 1.8 .7 .2 .1 58 27 11 3 1 8.1 4.5 2.9 .6 .1 .0 55 36 7 1 0 10.0 6.9 2.6 .4 .1 .0 69 27 4 1 0 4.8 2.1 2.3 .3 .1 .0 44 48 6 1 0 9.3 5.6 3.0 .6 .1 .0 56 36 7 1 0 4.59 3.89 1.07 .40 .08 .05 13.2 14.2 2.7 1.0 .4 6 6 6 6 6 6 6 6 6 6 6 540 Appendix 4 Individual Clinical Hematology Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05530 - - - - - I05531 - - - - - I05535 - - - - - I05544 - - - - - I05549 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 - - - - - I05541 - - - - - I05547 - - - - - I05550 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 - - - - - I05538 - - - - - I05539 - - - - - I05545 - - - - - I05548 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05534 - - - - - I05536 - - - - - I05540 - - - - - I05542 - - - - - I05551 - - - - - Covance 6329-223 3M T-6295.7 541 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.39 12.8 39.6 62.0 20.0 32.2 387 .3 19 6.21 12.8 41.3 66.6 20.7 31.1 406 .7 43 6.92 12.2 40.7 58.8 17.6 29.9 475 .1 7 6.45 12.1 39.2 60.8 18.8 30.8 671 .1 6 6.01 11.5 37.4 62.3 19.2 30.8 384 .2 12 6.59 12.8 43.8 66.4 19.4 29.3 614 .6 40 6.43 12.4 40.3 62.8 19.3 30.7 490 .3 .314 .53 2.17 3.11 1.06 1.00 124.3 .26 6 6 6 6 6 6 6 6 21 16.4 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.96 12.3 42.2 60.6 17.7 29.2 389 .3 21 6.71 12.8 42.9 63.9 19.1 29.8 630 1.0 67 6.43 12.2 40.4 62.8 19.0 30.2 290 1.3 84 7.88 13.4 44.7 56.8 17.0 30.0 741 .2 16 7.00 12.7 42.5 61.0 18.2 29.8 512 .7 .628 .55 1.78 3.13 1.02 .43 208.8 .54 4 4 4 4 4 4 4 4 47 33.7 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.07 12.1 39.4 64.8 19.9 30.7 505 1.6 97 6.64 12.2 39.6 59.6 18.3 30.7 487 .4 27 6.95 12.5 40.9 58.8 18.0 30.5 501 .2 14 6.33 12.5 40.0 63.2 19.7 31.2 585 .4 25 6.48 12.4 41.9 64.6 19.2 29.7 555 .2 13 6.51 12.3 40.3 61.8 18.8 30.5 346 .3 20 6.50 12.3 40.4 62.1 19.0 30.6 496 .5 .295 .16 .93 2.53 .76 .49 82.6 .54 6 6 6 6 6 6 6 6 33 32.0 6 542 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 7.22 13.0 42.6 59.0 18.0 30.5 522 .3 22 6.81 11.9 41.5 61.0 17.4 28.6 50 .4 27 6.37 11.3 38.3 60.2 17.7 29.4 475 .6 38 5.94 11.2 38.0 64.0 18.8 29.4 552 .4 24 7.13 12.9 43.0 60.2 18.1 30.0 396 .1 7 6.48 12.7 42.3 65.3 19.5 29.9 592 .6 39 6.66 12.2 41.0 61.6 18.2 29.6 431 .4 .488 .81 2.23 2.47 .77 .65 198.6 .19 6 6 6 6 6 6 6 6 26 11.8 6 543 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.1 2.3 3.2 .3 .2 .0 38 52 5 4 1 7.8 2.9 4.2 .6 .1 .1 37 54 8 1 1 5.8 2.5 3.0 .2 .0 .0 44 52 3 1 0 5.1 1.7 2.9 .4 .1 .0 34 57 8 1 1 5.1 1.7 2.8 .4 .1 .0 34 56 8 3 0 10.2 3.3 6.0 .6 .2 .0 33 59 6 2 0 6.7 2.4 3.7 .4 .1 .0 37 55 6 2 0 1.99 .64 1.24 .16 .08 .04 4.1 2.8 2.1 1.3 .5 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.9 3.5 2.6 .6 .3 .0 50 38 8 4 0 7.7 2.4 4.5 .6 .2 .0 31 58 8 2 0 10.6 6.4 3.4 .6 .1 .0 60 32 6 1 0 8.7 5.3 2.7 .6 .1 .0 61 31 7 1 0 8.5 4.4 3.3 .6 .2 .0 50 40 7 2 0 1.60 1.79 .88 .00 .10 .00 13.9 12.6 1.0 1.4 .0 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 8.9 6.2 2.2 .3 .1 .0 70 25 4 1 0 10.7 6.4 3.2 .9 .1 .1 60 30 9 1 1 15.8 7.9 6.8 1.0 .1 .1 50 43 6 1 1 8.6 4.3 3.7 .4 .1 .0 50 43 5 1 0 6.4 2.8 2.8 .7 .0 .1 44 44 11 0 1 11.4 6.8 3.4 .6 .5 .0 59 30 6 5 0 10.3 5.7 3.7 .6 .2 .0 56 36 7 2 0 3.21 1.85 1.61 .27 .18 .05 9.3 8.4 2.6 1.8 .5 6 6 6 6 6 6 6 6 6 6 6 544 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 7.9 3.6 3.5 .6 .1 .0 46 45 7 1 1 10.3 5.0 3.9 1.1 .2 .1 48 38 10 2 1 9.1 5.3 2.8 .5 .4 .0 58 31 6 5 0 11.5 7.5 3.4 .4 .2 .0 65 30 4 1 0 5.3 2.0 2.7 .5 .0 .1 38 50 10 1 1 12.3 7.0 4.6 .3 .4 .0 57 37 2 3 0 9.4 5.1 3.5 .6 .2 .0 52 38 6 2 0 2.56 2.06 .71 .28 .16 .05 9.8 7.8 3.2 1.6 .5 6 6 6 6 6 6 6 6 6 6 6 545 Appendix 4 Individual Clinical Hematology Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 - - - - - I05517 - - - - - I05519 - - - - - I05520 - - - - - I05526 - - - - - I05527 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 - - - - - I05515 - - - - - I05516 - - - - - I05521 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05510 - - - - - I05518 - - - - - I05523 - - - - - I05524 - - - - - I05528 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 - - - - - I05507 - - - - - I05509 - - - - - I05511 - - - - - I05512 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 546 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.13 11.9 38.3 62.5 19.4 31.0 682 .2 12 6.50 13.0 43.2 66.5 20.0 30.1 556 .3 20 6.44 12.0 39.2 60.9 18.6 30.5 629 .4 26 6.71 12.1 40.1 59.9 18.0 30.1 515 .4 27 5.26 11.3 37.0 70.4 21.5 30.5 446 .3 16 6.81 13.4 44.1 64.7 19.7 30.4 544 .3 20 6.31 12.3 40.3 64.1 19.5 30.4 562 .3 .565 .77 2.79 3.90 1.21 .33 83.6 .08 6 6 6 6 6 6 6 6 20 5.7 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.22 10.6 37.1 59.7 17.0 28.4 492 .5 31 5.52 12.8 40.8 73.9 23.1 31.3 462 .5 28 6.49 11.3 37.5 57.8 17.5 30.2 493 .6 39 6.55 12.2 41.3 63.0 18.6 29.6 422 .3 20 6.20 11.7 39.2 63.6 19.0 29.9 467 .5 .472 .97 2.18 7.19 2.78 1.21 33.4 .13 4 4 4 4 4 4 4 4 30 7.9 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.49 12.2 40.0 61.6 18.8 30.6 423 .2 13 6.70 12.0 40.8 61.0 18.0 29.5 432 .1 7 6.16 12.1 39.3 63.8 19.7 30.8 394 .3 18 6.89 12.7 40.9 59.3 18.4 31.1 355 .3 21 6.59 11.5 37.6 56.9 17.5 30.7 585 .3 20 6.14 11.7 37.8 61.6 19.0 30.9 461 .1 6 6.50 12.0 39.4 60.7 18.6 30.6 442 .2 .298 .42 1.44 2.35 .78 .57 78.9 .10 6 6 6 6 6 6 6 6 14 6.6 6 547 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 6.39 11.9 40.1 62.7 18.7 29.8 328 .1 6 6.06 11.8 39.8 65.7 19.5 29.7 520 .4 24 6.35 11.7 40.4 63.6 18.4 28.9 568 .1 6 6.47 12.5 42.2 65.2 19.3 29.5 597 .3 19 6.57 11.9 41.6 63.3 18.2 28.7 635 .0 0 6.07 11.4 37.8 62.3 18.7 30.1 378 .3 18 6.32 11.9 40.3 63.8 18.8 29.4 504 .2 .210 .36 1.54 1.37 .51 .54 124.1 .15 6 6 6 6 6 6 6 6 12 9.4 6 548 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.4 3.2 2.6 .5 .1 .0 50 41 8 1 1 11.1 6.2 4.1 .6 .2 .0 56 37 5 2 0 9.1 4.7 3.5 .6 .3 .0 51 38 7 3 0 11.7 3.0 7.1 .8 .7 .1 26 61 7 6 1 9.1 2.8 5.1 .6 .7 .0 30 56 6 7 0 8.7 4.4 3.5 .6 .2 .0 50 40 7 2 0 9.4 4.0 4.3 .6 .4 .0 44 46 7 4 0 1.89 1.31 1.59 .10 .27 .04 12.5 10.3 1.0 2.4 .5 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 8.3 3.5 3.0 1.3 .3 .2 42 37 15 3 2 10.4 4.4 4.9 .8 .2 .0 42 47 8 2 0 4.1 1.7 2.0 .3 .1 .0 41 48 8 3 0 12.0 8.2 2.9 .8 .1 .0 68 24 6 1 0 8.7 4.4 3.2 .8 .2 .0 48 39 9 2 0 3.42 2.74 1.22 .41 .10 .10 13.2 11.2 3.9 1.0 1.0 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.5 3.6 2.4 .3 .1 .0 56 37 5 2 0 9.5 5.2 3.2 .8 .2 .0 55 34 9 2 0 8.5 3.3 4.4 .5 .2 .0 39 52 6 2 1 8.8 4.4 3.5 .7 .1 .0 50 40 8 1 0 10.2 5.2 3.9 .7 .3 .0 51 38 7 3 0 8.9 4.9 3.1 .5 .4 .0 55 35 6 4 0 8.7 4.4 3.4 .6 .2 .0 51 39 7 2 0 1.25 .82 .69 .18 .12 .00 6.4 6.6 1.5 1.0 .4 6 6 6 6 6 6 6 6 6 6 6 549 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 8.2 3.1 4.3 .7 .1 .1 38 53 8 1 1 8.5 4.1 3.1 1.0 .2 .1 48 37 12 3 1 5.7 2.8 2.2 .6 .2 .0 50 38 10 3 0 10.7 6.5 3.8 .4 .1 .0 60 35 4 1 0 9.5 7.0 2.2 .3 .0 .0 74 23 3 0 0 6.2 4.1 1.7 .4 .1 .0 66 27 6 1 0 8.1 4.6 2.9 .6 .1 .0 56 36 7 2 0 1.91 1.75 1.02 .26 .08 .05 13.1 10.4 3.5 1.2 .5 6 6 6 6 6 6 6 6 6 6 6 550 Appendix 4 Individual Clinical Hematology Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05530 - - - - - I05531 - - - - - I05535 - - - - - I05544 - - - - - I05549 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 - - - - - I05541 - - - - - I05547 - - - - - I05550 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 - - - - - I05538 - - - - - I05539 - - - - - I05545 - - - - - I05548 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05534 - - - - - I05536 - - - - - I05540 - - - - - I05542 - - - - - I05551 - - - - - Covance 6329-223 3M T-6295.7 551 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.44 12.3 39.3 61.0 19.1 31.4 351 .1 6 6.54 13.1 43.3 66.3 20.0 30.2 379 .2 13 7.40 12.8 42.9 58.0 17.3 29.9 447 .4 30 6.44 12.1 38.7 60.1 18.8 31.2 643 .0 0 6.28 11.7 38.6 61.3 18.7 30.5 354 .1 6 6.95 12.9 42.8 61.6 18.5 30.1 613 .7 49 6.68 12.5 40.9 61.4 18.7 30.6 464 .2 .421 .54 2.28 2.74 .88 .62 131.6 .26 6 6 6 6 6 6 6 6 17 18.7 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.80 12.0 40.8 59.9 17.7 29.5 389 .2 14 7.26 13.0 44.0 60.7 17.9 29.5 618 .2 15 6.55 12.4 39.6 60.5 18.9 31.2 296 .4 26 7.71 12.9 42.4 55.0 16.7 30.4 630 .0 0 7.08 12.6 41.7 59.0 17.8 30.2 483 .2 .513 .46 1.91 2.70 .90 .82 167.0 .16 4 4 4 4 4 4 4 4 14 10.7 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.35 12.6 40.5 63.7 19.9 31.2 406 .5 32 7.19 12.6 41.3 57.5 17.5 30.5 496 .2 14 7.53 13.2 43.4 57.6 17.6 30.5 546 .4 30 6.39 12.2 39.8 62.3 19.2 30.8 783 .4 26 6.74 12.8 42.8 63.5 19.1 30.0 515 .6 40 6.50 12.2 40.2 61.9 18.8 30.4 366 .6 39 6.78 12.6 41.3 61.1 18.7 30.6 519 .4 .479 .38 1.47 2.82 .95 .40 146.4 .15 6 6 6 6 6 6 6 6 30 9.6 6 552 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 7.78 13.4 45.8 59.0 17.3 29.3 486 .4 31 6.93 11.7 39.3 56.7 16.8 29.7 21 .1 7 6.08 10.3 36.1 59.4 16.9 28.5 373 .7 43 6.10 11.1 37.7 61.8 18.2 29.5 553 1.1 67 6.61 12.0 40.4 61.2 18.2 29.7 405 1.2 79 6.38 12.1 40.5 63.6 19.0 29.9 552 .1 6 6.65 11.8 40.0 60.3 17.7 29.4 398 .6 .641 1.04 3.32 2.43 .87 .50 199.1 .48 6 6 6 6 6 6 6 6 39 30.3 6 553 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.3 1.8 2.9 .3 .4 .0 34 54 5 7 0 6.7 1.7 4.5 .4 .0 .0 25 68 6 0 0 6.7 2.9 3.5 .2 .1 .0 43 52 3 1 0 7.8 2.3 4.3 .7 .3 .2 30 55 9 4 2 5.2 1.6 2.9 .6 .1 .0 32 56 11 1 0 12.3 5.9 5.1 1.0 .1 .0 48 42 8 1 0 7.3 2.7 3.9 .5 .2 .0 35 54 7 2 0 2.62 1.64 .91 .29 .15 .08 8.6 8.3 2.9 2.7 .8 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 10.0 6.2 3.0 .4 .3 .0 62 30 4 3 0 8.8 3.1 4.8 .6 .2 .0 35 55 7 3 0 11.3 6.4 3.8 .9 .2 .0 56 34 8 2 0 9.6 6.8 2.3 .5 .1 .0 70 24 5 1 0 9.9 5.6 3.5 .6 .2 .0 56 36 6 2 0 1.04 1.70 1.08 .22 .08 .00 15.0 13.5 1.8 1.0 .0 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 11.8 8.6 2.5 .5 .3 .0 73 21 4 2 0 9.3 5.5 3.1 .6 .1 .0 59 33 7 1 0 9.7 2.9 5.9 .8 .1 .1 30 61 9 1 1 13.8 8.3 4.4 .6 .4 .0 60 32 4 3 0 6.7 1.9 4.1 .7 .1 .1 28 61 10 1 1 9.2 3.8 3.9 .8 .6 .1 42 43 8 6 1 10.1 5.2 4.0 .7 .3 .0 49 42 7 2 0 2.44 2.81 1.17 .12 .21 .05 18.2 16.4 2.5 2.0 .5 6 6 6 6 6 6 6 6 6 6 6 554 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 6.7 2.5 3.6 .5 .1 .0 38 54 7 1 0 8.9 3.9 4.4 .5 .1 .0 44 50 5 1 0 13.2 10.0 1.8 1.4 .0 .0 76 13 11 0 0 5.9 2.2 3.2 .3 .2 .0 37 55 6 3 0 7.6 2.2 4.0 1.2 .1 .0 29 53 15 2 0 11.6 5.2 4.9 .9 .5 .1 45 42 8 4 1 9.0 4.3 3.6 .8 .2 .0 45 44 9 2 0 2.87 3.02 1.08 .44 .18 .04 16.3 16.1 3.7 1.5 .4 6 6 6 6 6 6 6 6 6 6 6 555 Appendix 4 Individual Clinical Hematology Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 - - - - - I05517 - - - - - I05519 - - - - - I05520 - - - - - I05526 - - - - - I05527 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 - - - - - I05515 - - - - - I05516 - - - - - I05521 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05510 - - - - - I05518 - - - - - I05523 - - - - - I05524 - - - - - I05528 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 - - - - - I05507 - - - - - I05509 - - - - - I05511 - - - - - I05512 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 556 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.82 11.3 36.1 61.9 19.3 31.2 609 .2 12 6.31 12.5 41.0 65.1 19.8 30.4 544 .5 32 6.88 12.6 40.7 59.1 18.3 31.0 586 .1 7 7.30 12.9 42.9 58.7 17.7 30.2 469 .0 0 6.25 11.6 38.7 62.0 18.6 30.0 498 .7 44 7.02 13.6 44.4 63.3 19.3 30.5 416 .7 49 6.60 12.4 40.6 61.7 18.8 30.6 520 .4 .559 .85 2.96 2.45 .77 .46 73.1 .31 6 6 6 6 6 6 6 6 24 20.5 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.74 10.9 38.5 57.0 16.2 28.4 322 .4 27 5.74 12.2 40.3 70.3 21.2 30.2 385 1.5 86 6.96 11.7 39.0 56.0 16.8 30.0 450 .1 7 7.20 13.1 43.9 61.0 18.2 29.8 391 .5 36 6.66 12.0 40.4 61.1 18.1 29.6 387 .6 .641 .92 2.44 6.52 2.23 .82 52.3 .61 4 4 4 4 4 4 4 4 39 33.6 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.80 12.5 40.8 60.0 18.4 30.7 424 .7 48 6.37 11.7 38.5 60.5 18.4 30.4 425 .4 25 6.59 12.3 40.6 61.6 18.7 30.3 506 .3 20 7.00 12.7 41.5 59.3 18.1 30.6 326 .0 0 6.84 11.6 38.3 55.9 17.0 30.3 545 .2 14 6.39 11.9 39.4 61.6 18.7 30.3 532 .2 13 6.66 12.1 39.9 59.8 18.2 30.4 460 .3 .257 .45 1.31 2.12 .64 .18 83.7 .24 6 6 6 6 6 6 6 6 20 16.1 6 557 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 6.67 12.2 41.2 61.7 18.4 29.8 320 .3 20 6.20 12.1 41.4 66.7 19.5 29.3 582 .3 19 6.07 11.0 36.8 60.7 18.2 30.0 563 .1 6 5.97 11.5 37.3 62.4 19.2 30.8 491 .0 0 6.56 11.6 40.0 60.9 17.6 28.9 671 .1 7 6.51 11.9 40.3 61.9 18.3 29.6 322 .2 13 6.33 11.7 39.5 62.4 18.5 29.7 492 .2 .288 .44 1.98 2.21 .70 .65 144.0 .12 6 6 6 6 6 6 6 6 11 7.9 6 558 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 8.4 5.1 2.6 .6 .1 .0 60 31 7 1 0 8.3 1.8 5.9 .5 .1 .0 22 70 6 2 0 14.5 9.9 3.8 .7 .1 .0 68 26 5 1 0 8.3 2.4 4.4 1.0 .5 .1 28 52 12 6 1 8.7 2.9 3.9 1.3 .4 .1 34 45 15 5 1 10.0 5.3 3.8 .7 .1 .1 53 38 7 1 1 9.7 4.6 4.1 .8 .2 .0 44 44 9 3 0 2.44 2.98 1.08 .30 .18 .05 18.7 15.9 3.9 2.3 .5 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 8.5 4.2 3.0 .9 .4 .2 49 35 10 4 2 6.5 2.2 3.6 .5 .1 .1 34 56 8 1 1 15.9 10.2 2.8 2.6 .1 .1 64 18 16 1 0 6.4 3.5 2.1 .5 .2 .0 55 34 9 2 0 9.3 5.0 2.9 1.1 .2 .1 50 36 11 2 1 4.49 3.55 .62 1.00 .14 .08 12.6 15.6 3.6 1.4 1.0 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 5.6 2.5 2.4 .6 .1 .0 45 43 10 1 1 10.6 6.6 2.9 .8 .3 .0 63 27 7 3 0 6.3 1.1 4.5 .5 .2 .0 18 71 8 3 0 11.0 5.3 4.8 .6 .2 .0 48 44 5 2 0 7.6 3.2 3.1 .8 .4 .0 42 41 11 5 0 7.5 3.4 3.0 .5 .5 .0 45 40 7 6 1 8.1 3.7 3.4 .6 .3 .0 44 44 8 3 0 2.23 1.98 .96 .14 .15 .00 14.5 14.4 2.2 1.9 .5 6 6 6 6 6 6 6 6 6 6 6 559 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 8.2 2.1 4.9 .9 .2 .1 26 60 11 3 1 13.2 3.8 7.9 1.0 .4 .1 29 60 7 3 1 10.1 6.6 1.9 1.3 .2 .1 65 19 13 2 1 11.7 7.4 3.5 .6 .1 .0 64 30 5 1 0 9.0 5.0 3.6 .3 .2 .0 55 39 3 2 0 4.6 1.7 2.2 .6 .0 .0 38 48 13 1 1 9.5 4.4 4.0 .8 .2 .0 46 43 9 2 1 2.99 2.33 2.19 .35 .13 .05 17.4 16.5 4.3 .9 .5 6 6 6 6 6 6 6 6 6 6 6 560 Appendix 4 Individual Clinical Hematology Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05530 - - - - - I05531 - - - - - I05535 - - - - - I05544 - - - - - I05549 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 - - - - - I05541 - - - - - I05547 - - - - - I05550 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 - - - - - I05538 - - - - - I05539 - - - - - I05545 - - - - - I05548 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05534 - - - - - I05536 - - - - - I05540 - - - - - I05542 - - - - - I05551 - - - - - Covance 6329-223 3M T-6295.7 561 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.43 12.8 40.3 62.7 19.9 31.7 404 .1 6 6.72 13.1 44.2 65.8 19.5 29.6 399 .2 13 7.22 12.7 42.0 58.1 17.6 30.2 445 .2 14 6.17 11.7 38.0 61.6 18.9 30.7 591 .1 6 6.48 12.2 40.4 62.3 18.8 30.2 392 .1 6 6.57 12.3 41.7 63.5 18.8 29.6 571 .3 20 6.60 12.5 41.1 62.3 18.9 30.3 467 .2 .354 .50 2.07 2.53 .78 .79 90.4 .08 6 6 6 6 6 6 6 6 11 5.8 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.88 12.1 42.5 61.7 17.6 28.5 398 .4 28 6.47 12.2 40.7 62.9 18.8 29.9 559 .2 13 6.61 12.5 40.8 61.7 18.9 30.6 246 .0 0 7.86 13.1 44.5 56.6 16.7 29.5 663 .1 8 6.96 12.5 42.1 60.7 18.0 29.6 466 .2 .627 .45 1.79 2.81 1.05 .88 183.0 .17 4 4 4 4 4 4 4 4 12 11.8 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.43 12.5 41.8 65.0 19.5 30.0 411 .3 19 6.98 12.4 40.8 58.4 17.8 30.4 464 .3 21 7.21 12.8 42.1 58.4 17.7 30.4 514 .3 22 6.50 12.6 40.7 62.6 19.3 30.9 526 .3 20 6.57 12.6 41.8 63.5 19.2 30.2 527 .2 13 6.21 11.9 39.0 62.9 19.1 30.4 380 .3 19 6.65 12.5 41.0 61.8 18.8 30.4 470 .3 .372 .31 1.15 2.76 .80 .30 63.1 .04 6 6 6 6 6 6 6 6 19 3.2 6 562 ANIMAL NUMBER ------ Group: 4 I05506 a I05507 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 7.69 13.3 44.3 57.7 17.2 29.9 560 .2 15 6.64 11.0 38.4 57.9 16.5 28.5 78 PA .3 20 5.76 10.4 35.7 62.0 18.1 29.2 486 .5 29 6.46 11.7 39.8 61.6 18.1 29.4 429 .0 0 6.44 12.3 41.5 64.5 19.1 29.6 610 .0 0 6.32 11.4 38.8 61.5 17.9 29.2 401 .2 .387 .83 2.45 2.72 1.08 .48 228.0 .24 4 4 4 4 4 4 4 4 12 14.6 4 a Unscheduled sacrifice on Day 179. 563 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 9.5 3.6 4.8 .6 .5 .0 38 50 6 6 0 9.0 2.6 5.6 .6 .1 .1 30 62 7 1 1 6.8 4.0 2.5 .3 .1 .0 58 37 4 1 0 12.0 5.8 5.0 .7 .4 .1 49 42 6 3 1 10.0 6.7 2.8 .4 .1 .0 67 28 4 1 0 10.8 2.8 6.0 1.6 .3 .1 26 55 15 3 1 9.7 4.2 4.4 .7 .2 .0 45 46 7 2 0 1.76 1.66 1.46 .46 .18 .05 16.1 12.4 4.1 2.0 .5 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 8.9 5.7 2.6 .4 .2 .0 64 30 4 2 0 7.5 2.7 3.6 .9 .2 .0 36 48 12 3 1 8.1 5.8 1.9 .3 .1 .0 71 23 4 1 0 9.1 5.2 3.2 .6 .1 .0 58 35 6 1 0 8.4 4.8 2.8 .6 .2 .0 57 34 6 2 0 .74 1.46 .74 .26 .06 .00 15.1 10.6 3.8 1.0 .5 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 10.3 7.5 2.3 .4 .2 .0 72 22 4 2 0 9.1 4.6 3.9 .4 .1 .0 51 43 5 1 0 13.6 6.6 6.6 .3 .1 .0 48 48 2 0 0 10.8 6.3 3.8 .5 .1 .0 59 35 5 1 0 6.1 1.6 3.8 .5 .1 .0 26 63 9 1 0 10.0 4.6 4.1 .7 .6 .0 46 41 7 6 0 10.0 5.2 4.1 .5 .2 .0 50 42 5 2 0 2.44 2.10 1.39 .14 .20 .00 15.2 13.6 2.4 2.1 .0 6 6 6 6 6 6 6 6 6 6 6 564 ANIMAL NUMBER ------ Group: 4 I05506 a I05507 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 19.7 14.7 4.0 1.0 .0 .0 74 20 5 0 0 9.4 3.9 4.9 .4 .1 .0 42 52 5 1 0 5.1 2.0 2.3 .6 .2 .1 39 45 11 4 1 6.6 1.9 4.3 .4 .0 .0 28 66 5 0 0 9.2 3.9 4.5 .6 .2 .1 43 49 6 2 1 7.6 2.9 4.0 .5 .1 .0 38 53 7 2 0 2.09 1.13 1.16 .12 .10 .06 6.9 9.1 2.9 1.7 .6 4 4 4 4 4 4 4 4 4 4 4 a Unscheduled sacrifice on Day 179. 565 Appendix 4 Individual Clinical Hematology Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 - - - - - I05517 - - - - - I05519 - - - - - I05520 - - - - - I05526 - - - - - I05527 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 - - - - - I05515 - - - - - I05516 b - - - - - I05521 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05510 - - - - - I05518 - - - - - I05523 - - - - - I05524 - - - - - I05528 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 a - - - - - I05507 - - - - - I05511 - - - - - I05512 - - - - - I05522 - - - - - a Unscheduled sacrifice on Day 179. b Plasmodium was observed. 566 Covance 6329-223 3M T-6295.7 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.66 11.0 35.7 63.0 19.5 31.0 595 .2 11 6.38 12.6 42.6 66.8 19.7 29.6 583 .4 26 6.63 12.0 40.5 61.2 18.1 29.5 534 .3 20 7.04 12.7 42.8 60.8 18.1 29.7 369 .2 14 6.20 11.9 40.9 65.9 19.2 29.1 439 .8 50 6.52 12.5 42.3 64.9 19.2 29.6 383 .6 39 6.40 12.1 40.8 63.8 19.0 29.7 484 .4 .461 .64 2.67 2.49 .70 .65 100.1 .24 6 6 6 6 6 6 6 6 27 15.1 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 6.69 10.8 38.9 58.2 16.2 27.9 442 .2 13 5.80 12.2 41.4 71.3 21.1 29.5 380 .2 12 5.20 9.0 30.1 58.0 17.4 30.0 501 .4 21 6.92 12.7 42.7 61.8 18.3 29.7 394 .1 7 6.15 11.2 38.3 62.3 18.2 29.3 429 .2 .798 1.66 5.67 6.23 2.09 .94 54.7 .13 4 4 4 4 4 4 4 4 13 5.8 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.65 12.3 40.8 61.3 18.4 30.1 373 .3 20 6.14 11.0 37.6 61.2 17.9 29.3 381 .3 18 6.67 12.5 41.9 62.7 18.8 29.9 400 .2 13 6.81 12.4 41.0 60.3 18.3 30.3 318 .0 0 6.75 11.3 37.8 56.1 16.8 30.0 484 .2 14 6.38 11.9 40.2 63.0 18.7 29.7 517 .1 6 6.57 11.9 39.9 60.8 18.2 29.9 412 .2 .256 .62 1.78 2.50 .73 .35 74.4 .12 6 6 6 6 6 6 6 6 12 7.5 6 567 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 6.00 11.3 37.6 62.6 18.9 30.1 288 .2 12 5.65 11.0 37.7 66.8 19.4 29.1 587 .5 28 6.08 10.9 39.3 64.6 17.9 27.8 559 .0 0 5.99 11.6 38.6 64.5 19.3 29.9 454 .0 0 6.75 11.9 43.4 64.3 17.7 27.5 725 .4 27 6.09 11.3 38.4 63.1 18.6 29.5 328 .1 6 6.09 11.3 39.2 64.3 18.6 29.0 490 .2 .360 .37 2.17 1.46 .71 1.09 166.0 .21 6 6 6 6 6 6 6 6 12 12.7 6 568 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 14.6 11.4 2.5 .6 .1 .1 78 17 4 1 1 7.3 2.6 3.9 .6 .2 .0 35 54 8 3 0 10.5 5.2 4.3 .7 .2 .1 50 41 7 2 1 13.9 5.5 7.0 1.0 .3 .1 39 50 7 2 1 10.4 2.9 6.2 .6 .6 .0 28 60 6 6 0 5.4 2.4 2.1 .7 .1 .0 44 40 14 2 0 10.4 5.0 4.3 .7 .2 .0 46 44 8 3 0 3.59 3.41 1.96 .15 .19 .05 17.5 15.1 3.4 1.8 .5 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 10.1 5.4 3.1 1.1 .4 .2 54 30 11 4 2 6.6 2.4 3.5 .5 .2 .0 37 53 7 3 0 6.8 4.0 2.4 .4 .1 .0 58 35 6 1 0 10.4 5.5 3.7 .8 .4 .0 53 35 7 4 0 8.5 4.3 3.2 .7 .3 .0 50 38 8 3 0 2.05 1.45 .57 .32 .15 .10 9.3 10.1 2.2 1.4 1.0 4 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 8.2 3.9 3.8 .4 .1 .0 48 46 5 1 0 9.2 4.5 3.8 .6 .3 .0 49 41 6 4 0 7.5 1.6 4.9 .8 .1 .1 22 65 10 2 2 11.0 6.3 3.9 .6 .1 .0 57 36 6 1 0 11.3 6.2 3.7 .6 .7 .0 55 33 5 6 0 8.0 4.3 3.0 .3 .4 .0 54 37 4 4 0 9.2 4.5 3.8 .6 .3 .0 48 43 6 3 0 1.61 1.73 .61 .18 .24 .04 13.0 11.7 2.1 2.0 .8 6 6 6 6 6 6 6 6 6 6 6 569 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 7.5 3.2 3.8 .4 .1 .1 42 51 5 1 1 12.1 5.0 6.0 1.0 .2 .1 41 49 8 1 1 8.4 4.1 2.8 1.2 .2 .1 49 34 14 2 1 10.3 5.9 3.8 .5 .1 .0 58 37 5 1 0 13.4 3.0 9.3 .8 .3 .1 22 69 6 3 0 6.4 4.0 1.8 .5 .1 .0 63 28 8 1 0 9.7 4.2 4.6 .7 .2 .1 46 45 8 2 0 2.73 1.10 2.70 .32 .08 .05 14.6 14.8 3.4 .8 .5 6 6 6 6 6 6 6 6 6 6 6 570 Appendix 4 Individual Clinical Hematology Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05530 - - - - - I05531 - - - - - I05535 - - - - - I05544 - - - - - I05549 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 - - - - - I05541 - - - - - I05547 - - - - - I05550 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 - - - - - I05538 - - - - - I05539 - - - - - I05545 - - - - - I05548 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05534 - - - - - I05536 - - - - - I05540 - - - - - I05542 - - - - - I05551 - - - - - Covance 6329-223 3M T-6295.7 571 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.27 12.1 38.3 61.0 19.3 31.7 620 .3 19 6.26 11.8 37.9 60.5 18.9 31.2 346 .4 25 6.26 12.0 38.1 60.8 19.1 31.5 483 .4 .007 .21 .28 .35 .28 .35 193.7 .07 2 2 2 2 2 2 2 2 22 4.2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.53 13.0 41.6 63.7 19.9 31.3 404 .4 26 6.45 12.4 39.8 61.8 19.3 31.2 572 .2 13 6.49 12.7 40.7 62.8 19.6 31.2 488 .3 .057 .42 1.27 1.34 .42 .07 118.8 .14 2 2 2 2 2 2 2 2 20 9.2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 5.93 11.6 38.2 64.5 19.5 30.3 485 .3 18 5.87 11.5 37.3 63.5 19.6 30.9 453 .6 35 5.90 11.6 37.8 64.0 19.5 30.6 469 .4 .042 .07 .64 .71 .07 .42 22.6 .21 2 2 2 2 2 2 2 2 26 12.0 2 572 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 8.5 2.5 5.2 .5 .3 .0 30 61 6 3 1 6.1 2.3 2.9 .7 .2 .0 37 47 12 3 1 7.3 2.4 4.0 .6 .2 .0 34 54 9 3 1 1.70 .14 1.63 .14 .07 .00 4.9 9.9 4.2 .0 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 8.8 4.7 3.0 .7 .4 .0 53 34 8 5 0 14.2 7.6 6.0 .4 .2 .0 53 42 3 1 0 11.5 6.2 4.5 .6 .3 .0 53 38 6 3 0 3.82 2.05 2.12 .21 .14 .00 .0 5.7 3.5 2.8 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 8.9 4.1 3.9 .5 .4 .0 46 44 5 4 0 14.7 7.9 5.0 1.3 .5 .0 54 34 9 4 0 11.8 6.0 4.4 .9 .4 .0 50 39 7 4 0 4.10 2.69 .78 .57 .07 .00 5.7 7.1 2.8 .0 .0 2 2 2 2 2 2 2 2 2 2 2 573 APPENDIX 4 Individual Clinical Hematology Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 - - - - - I05526 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05523 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 574 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.44 10.9 33.5 61.5 20.1 32.7 547 .1 5 6.45 12.6 40.3 62.4 19.6 31.3 390 .5 32 5.94 11.8 36.9 62.0 19.8 32.0 468 .3 .714 1.20 4.81 .64 .35 .99 111.0 .28 2 2 2 2 2 2 2 2 18 19.1 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.07 11.8 37.2 61.4 19.5 31.8 382 .2 12 6.20 12.0 38.0 61.3 19.4 31.6 435 .5 31 6.14 11.9 37.6 61.4 19.5 31.7 408 .4 .092 .14 .57 .07 .07 .14 37.5 .21 2 2 2 2 2 2 2 2 22 13.4 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.13 11.8 38.2 62.2 19.2 30.8 330 .3 18 6.72 12.2 42.3 63.0 18.2 28.9 557 .7 47 6.42 12.0 40.2 62.6 18.7 29.8 444 .5 .417 .28 2.90 .57 .71 1.34 160.5 .28 2 2 2 2 2 2 2 2 32 20.5 2 575 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 10.1 6.1 3.0 .8 .1 .0 60 30 8 1 0 6.2 3.1 2.5 .4 .1 .0 50 41 7 2 0 8.2 4.6 2.8 .6 .1 .0 55 36 8 2 0 2.76 2.12 .35 .28 .00 .00 7.1 7.8 .7 .7 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.9 1.8 4.3 .7 .2 .1 26 61 10 3 1 8.4 3.5 3.8 .5 .5 .0 41 45 6 6 1 7.6 2.6 4.0 .6 .4 .0 34 53 8 4 1 1.06 1.20 .35 .14 .21 .07 10.6 11.3 2.8 2.1 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 7.7 2.1 5.0 .3 .3 .0 27 65 4 4 0 10.9 3.0 6.7 .8 .2 .1 28 62 8 2 1 9.3 2.6 5.8 .6 .2 .0 28 64 6 3 0 2.26 .64 1.20 .35 .07 .07 .7 2.1 2.8 1.4 .7 2 2 2 2 2 2 2 2 2 2 2 576 APPENDIX 4 Individual Clinical Hematology Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05549 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05542 - - - - - Covance 6329-223 3M T-6295.7 577 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.75 13.0 40.6 60.2 19.3 32.1 685 .1 7 6.28 12.2 37.9 60.3 19.4 32.1 428 .3 19 6.52 12.6 39.2 60.2 19.4 32.1 556 .2 .332 .57 1.91 .07 .07 .00 181.7 .14 2 2 2 2 2 2 2 2 13 8.5 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.75 13.3 42.5 62.9 19.8 31.4 467 .1 7 6.82 13.3 41.8 61.3 19.4 31.7 519 .2 14 6.78 13.3 42.2 62.1 19.6 31.6 493 .2 .049 .00 .49 1.13 .28 .21 36.8 .07 2 2 2 2 2 2 2 2 10 4.9 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.06 11.4 39.0 64.4 18.8 29.2 501 .8 48 6.33 12.4 39.9 63.0 19.5 31.0 562 .4 25 6.20 11.9 39.5 63.7 19.2 30.1 532 .6 .191 .71 .64 .99 .49 1.27 43.1 .28 2 2 2 2 2 2 2 2 36 16.3 2 578 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 12.1 3.8 7.6 .5 .3 .0 31 63 4 2 0 8.0 2.7 4.6 .4 .3 .0 33 58 5 4 0 10.0 3.2 6.1 .4 .3 .0 32 60 4 3 0 2.90 .78 2.12 .07 .00 .00 1.4 3.5 .7 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 10.6 5.2 4.1 .8 .4 .0 49 39 8 4 0 12.2 5.8 5.6 .4 .3 .0 48 46 3 2 0 11.4 5.5 4.8 .6 .4 .0 48 42 6 3 0 1.13 .42 1.06 .28 .07 .00 .7 4.9 3.5 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 9.5 3.6 4.9 .6 .4 .1 38 51 6 4 1 17.3 7.6 7.4 1.5 .6 .1 44 43 9 4 1 13.4 5.6 6.2 1.0 .5 .1 41 47 8 4 1 5.52 2.83 1.77 .64 .14 .00 4.2 5.7 2.1 .0 .0 2 2 2 2 2 2 2 2 2 2 2 579 APPENDIX 4 Individual Clinical Hematology Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 - - - - - I05526 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05523 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 580 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.70 11.3 34.9 61.1 19.8 32.4 577 .2 11 6.74 13.3 41.9 62.1 19.7 31.7 461 .3 20 6.22 12.3 38.4 61.6 19.8 32.1 519 .2 .735 1.41 4.95 .71 .07 .49 82.0 .07 2 2 2 2 2 2 2 2 16 6.4 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.88 12.9 40.9 59.4 18.7 31.4 391 .1 7 6.61 12.5 40.4 61.2 18.9 31.0 459 .2 13 6.74 12.7 40.7 60.3 18.8 31.2 425 .2 .191 .28 .35 1.27 .14 .28 48.1 .07 2 2 2 2 2 2 2 2 10 4.2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.38 12.2 39.9 62.5 19.2 30.7 335 .1 6 7.02 12.8 44.1 62.8 18.2 29.0 546 .4 28 6.70 12.5 42.0 62.7 18.7 29.8 440 .2 .453 .42 2.97 .21 .71 1.20 149.2 .21 2 2 2 2 2 2 2 2 17 15.6 2 581 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 12.5 9.1 2.8 .5 .1 .0 73 22 4 1 0 10.3 5.1 4.0 .9 .3 .0 50 39 8 3 0 11.4 7.1 3.4 .7 .2 .0 62 30 6 2 0 1.56 2.83 .85 .28 .14 .00 16.3 12.0 2.8 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 7.5 .9 5.3 1.0 .2 .1 12 71 13 3 1 11.4 5.1 4.6 1.0 .6 .0 45 40 9 5 0 9.4 3.0 5.0 1.0 .4 .0 28 56 11 4 0 2.76 2.97 .49 .00 .28 .07 23.3 21.9 2.8 1.4 .7 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 10.8 4.5 5.0 1.1 .2 .1 41 46 10 1 1 11.1 2.6 7.5 .7 .3 .1 23 67 6 3 1 11.0 3.6 6.2 .9 .2 .1 32 56 8 2 1 .21 1.34 1.77 .28 .07 .00 12.7 14.8 2.8 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 582 APPENDIX 4 Individual Clinical Hematology Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05549 a - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05542 - - - - - a Plasmodium was observed. Covance 6329-223 3M T-6295.7 583 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.86 13.0 41.6 60.6 19.0 31.3 666 .2 14 6.58 12.3 38.6 58.7 18.7 31.9 343 .3 20 6.72 12.6 40.1 59.6 18.8 31.6 504 .2 .198 .49 2.12 1.34 .21 .42 228.4 .07 2 2 2 2 2 2 2 2 17 4.2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.86 13.4 43.2 62.9 19.5 31.0 421 .6 41 6.71 12.8 40.3 60.1 19.1 31.7 570 .2 13 6.78 13.1 41.8 61.5 19.3 31.4 496 .4 .106 .42 2.05 1.98 .28 .49 105.4 .28 2 2 2 2 2 2 2 2 27 19.8 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.10 11.5 39.3 64.4 18.9 29.3 476 .4 24 6.80 13.1 42.7 62.8 19.2 30.6 562 .2 14 6.45 12.3 41.0 63.6 19.1 29.9 519 .3 .495 1.13 2.40 1.13 .21 .92 60.8 .14 2 2 2 2 2 2 2 2 19 7.1 2 584 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 7.6 2.4 4.0 1.0 .1 .0 32 53 13 2 1 7.0 2.8 3.4 .5 .1 .1 41 49 7 2 1 7.3 2.6 3.7 .8 .1 .0 36 51 10 2 1 .42 .28 .42 .35 .00 .07 6.4 2.8 4.2 .0 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 13.1 8.1 4.0 .6 .3 .0 62 30 5 3 0 9.9 5.2 4.2 .3 .1 .0 53 42 3 1 0 11.5 6.6 4.1 .4 .2 .0 58 36 4 2 0 2.26 2.05 .14 .21 .14 .00 6.4 8.5 1.4 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 7.2 2.5 4.0 .5 .2 .0 34 56 7 2 1 16.0 7.5 6.7 1.2 .5 .1 47 42 7 3 1 11.6 5.0 5.4 .8 .4 .0 40 49 7 2 1 6.22 3.54 1.91 .49 .21 .07 9.2 9.9 .0 .7 .0 2 2 2 2 2 2 2 2 2 2 2 585 APPENDIX 4 Individual Clinical Hematology Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 - - - - - I05526 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05523 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 586 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.55 11.1 33.7 60.7 20.0 33.0 606 .4 22 7.08 13.5 44.4 62.7 19.0 30.3 414 .4 28 6.32 12.3 39.0 61.7 19.5 31.6 510 .4 1.082 1.70 7.57 1.41 .71 1.91 135.8 .00 2 2 2 2 2 2 2 2 25 4.2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.59 12.6 39.7 60.2 19.1 31.7 419 .5 33 6.69 12.5 40.5 60.5 18.6 30.8 427 .2 13 6.64 12.6 40.1 60.3 18.8 31.2 423 .4 .071 .07 .57 .21 .35 .64 5.7 .21 2 2 2 2 2 2 2 2 23 14.1 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.49 12.2 39.7 61.2 18.8 30.7 343 .7 45 7.07 12.7 41.9 59.3 17.9 30.2 538 .2 14 6.78 12.5 40.8 60.2 18.4 30.5 440 .4 .410 .35 1.56 1.34 .64 .35 137.9 .35 2 2 2 2 2 2 2 2 30 21.9 2 587 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 9.6 7.1 2.1 .4 .0 .0 73 22 4 0 0 8.0 3.7 3.5 .6 .1 .0 46 44 8 2 1 8.8 5.4 2.8 .5 .0 .0 60 33 6 1 0 1.13 2.40 .99 .14 .07 .00 19.1 15.6 2.8 1.4 .7 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.2 1.1 4.3 .5 .2 .0 18 69 8 4 1 9.4 4.7 3.4 .6 .6 .1 50 37 7 6 1 7.8 2.9 3.8 .6 .4 .0 34 53 8 5 1 2.26 2.55 .64 .07 .28 .07 22.6 22.6 .7 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 10.8 5.0 4.7 1.0 .1 .1 46 43 9 0 1 7.6 3.7 3.5 .3 .1 .0 49 46 4 1 0 9.2 4.4 4.1 .6 .1 .0 48 44 6 0 0 2.26 .92 .85 .49 .00 .07 2.1 2.1 3.5 .7 .7 2 2 2 2 2 2 2 2 2 2 2 588 APPENDIX 4 Individual Clinical Hematology Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05549 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05542 - - - - - Covance 6329-223 3M T-6295.7 589 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.78 12.9 40.6 59.8 19.0 31.8 692 .5 34 6.67 12.4 39.8 59.7 18.6 31.2 396 .1 7 6.72 12.6 40.2 59.8 18.8 31.5 544 .3 .078 .35 .57 .07 .28 .42 209.3 .28 2 2 2 2 2 2 2 2 20 19.1 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.89 13.6 43.2 62.6 19.8 31.6 434 .2 14 6.71 12.8 40.6 60.5 19.1 31.5 548 .1 7 6.80 13.2 41.9 61.5 19.4 31.5 491 .2 .127 .57 1.84 1.48 .49 .07 80.6 .07 2 2 2 2 2 2 2 2 10 4.9 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.08 11.5 37.8 62.1 18.9 30.5 542 .8 49 6.36 12.1 38.3 60.2 19.0 31.5 603 .3 19 6.22 11.8 38.1 61.1 19.0 31.0 572 .6 .198 .42 .35 1.34 .07 .71 43.1 .35 2 2 2 2 2 2 2 2 34 21.2 2 590 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 9.5 4.3 4.5 .6 .1 .0 45 47 7 1 0 7.8 4.0 3.0 .7 .1 .0 52 38 9 1 0 8.6 4.2 3.8 .6 .1 .0 48 42 8 1 0 1.20 .21 1.06 .07 .00 .00 4.9 6.4 1.4 .0 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 13.7 9.6 3.0 .9 .2 .0 70 22 7 1 0 11.8 6.7 4.4 .6 .1 .0 57 37 5 1 0 12.8 8.2 3.7 .8 .2 .0 64 30 6 1 0 1.34 2.05 .99 .21 .07 .00 9.2 10.6 1.4 .0 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.3 2.2 3.1 .8 .2 .1 36 49 12 3 1 11.6 5.8 4.7 .9 .1 .0 50 40 8 1 0 9.0 4.0 3.9 .8 .2 .0 43 44 10 2 0 3.75 2.55 1.13 .07 .07 .07 9.9 6.4 2.8 1.4 .7 2 2 2 2 2 2 2 2 2 2 2 591 APPENDIX 4 Individual Clinical Hematology Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 - - - - - I05526 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05523 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 592 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.04 11.9 36.9 61.1 19.7 32.2 645 .1 6 6.61 12.8 39.9 60.4 19.4 32.1 447 .3 20 6.32 12.3 38.4 60.8 19.6 32.1 546 .2 .403 .64 2.12 .49 .21 .07 140.0 .14 2 2 2 2 2 2 2 2 13 9.9 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.81 12.5 39.6 58.2 18.3 31.5 399 .4 27 6.71 12.5 40.7 60.7 18.6 30.6 546 .3 20 6.76 12.5 40.1 59.4 18.4 31.0 472 .4 .071 .00 .78 1.77 .21 .64 103.9 .07 2 2 2 2 2 2 2 2 24 4.9 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.20 11.6 37.9 61.2 18.8 30.7 314 .1 6 6.81 12.2 41.0 60.3 17.9 29.7 534 .5 34 6.50 11.9 39.5 60.8 18.4 30.2 424 .3 .431 .42 2.19 .64 .64 .71 155.6 .28 2 2 2 2 2 2 2 2 20 19.8 2 593 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 14.9 10.0 3.2 1.4 .2 .0 67 22 10 1 0 8.7 4.4 3.3 .6 .3 .0 51 38 7 3 0 11.8 7.2 3.2 1.0 .2 .0 59 30 8 2 0 4.38 3.96 .07 .57 .07 .00 11.3 11.3 2.1 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 7.4 2.0 4.5 .7 .2 .0 27 61 10 3 0 11.4 6.5 3.9 .4 .6 .0 57 34 4 5 0 9.4 4.2 4.2 .6 .4 .0 42 48 7 4 0 2.83 3.18 .42 .21 .28 .00 21.2 19.1 4.2 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 7.8 2.3 5.0 .5 .1 .0 29 63 7 1 0 10.0 3.1 6.1 .6 .2 .0 31 61 6 2 0 8.9 2.7 5.6 .6 .2 .0 30 62 6 2 0 1.56 .57 .78 .07 .07 .00 1.4 1.4 .7 .7 .0 2 2 2 2 2 2 2 2 2 2 2 594 APPENDIX 4 Individual Clinical Hematology Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05549 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05542 - - - - - Covance 6329-223 3M T-6295.7 595 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.50 12.5 39.5 60.8 19.3 31.7 641 .2 13 6.56 12.4 39.4 60.1 19.0 31.6 387 .0 0 6.53 12.4 39.5 60.5 19.2 31.6 514 .1 6 .042 .07 .07 .49 .21 .07 179.6 .14 9.2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.92 13.5 43.3 62.7 19.6 31.3 399 .2 14 6.52 12.6 39.1 60.0 19.2 32.1 496 .0 0 6.72 13.0 41.2 61.3 19.4 31.7 448 .1 7 .283 .64 2.97 1.91 .28 .57 68.6 .14 9.9 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.09 12.0 39.1 64.2 19.7 30.6 520 1.5 91 6.37 12.3 38.7 60.8 19.3 31.8 495 .0 0 6.23 .198 2 12.2 .21 2 38.9 .28 2 62.5 2.40 2 19.5 .28 2 31.2 .85 2 508 17.7 2 .8 1.06 2 46 64.3 2 596 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 10.7 5.9 4.1 .6 .0 .1 55 38 6 0 1 10.9 7.3 2.8 .8 .1 .0 67 25 7 1 0 10.8 6.6 3.4 .7 .0 .0 61 32 6 0 0 .14 .99 .92 .14 .07 .07 8.5 9.2 .7 .7 .7 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 13.8 9.6 3.0 1.1 .2 .0 69 21 8 1 0 11.2 6.8 4.0 .4 .0 .0 60 36 4 0 0 12.5 8.2 3.5 .8 .1 .0 64 28 6 0 0 1.84 1.98 .71 .49 .14 .00 6.4 10.6 2.8 .7 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 9.4 4.5 3.7 .8 .3 .0 48 40 9 3 0 15.0 8.3 4.8 1.4 .4 .1 55 32 9 3 1 12.2 6.4 4.2 1.1 .4 .0 52 36 9 3 0 3.96 2.69 .78 .42 .07 .07 4.9 5.7 .0 .0 .7 2 2 2 2 2 2 2 2 2 2 2 597 APPENDIX 4 Individual Clinical Hematology Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO POLY POIK HYPO TOXNEUT -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 - - - - - I05526 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05523 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 598 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.96 11.9 36.1 60.5 19.9 32.9 635 .1 6 6.60 13.0 40.2 61.0 19.7 32.3 433 .2 13 6.28 12.4 38.1 60.8 19.8 32.6 534 .2 .453 .78 2.90 .35 .14 .42 142.8 .07 2 2 2 2 2 2 2 2 10 4.9 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.69 12.5 39.8 59.5 18.7 31.4 408 .2 13 6.85 12.7 41.7 60.8 18.6 30.5 504 .1 7 6.77 12.6 40.8 60.2 18.6 31.0 456 .2 .113 .14 1.34 .92 .07 .64 67.9 .07 2 2 2 2 2 2 2 2 10 4.2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.56 12.2 39.7 60.5 18.7 30.9 320 .1 7 6.52 12.1 40.5 62.1 18.5 29.8 577 .2 13 6.54 12.2 40.1 61.3 18.6 30.4 448 .2 .028 .07 .57 1.13 .14 .78 181.7 .07 2 2 2 2 2 2 2 2 10 4.2 2 599 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 8.5 4.2 3.1 .8 .3 .0 50 36 10 4 0 6.4 2.6 2.5 1.2 .1 .0 41 38 19 2 0 7.4 3.4 2.8 1.0 .2 .0 46 37 14 3 0 1.48 1.13 .42 .28 .14 .00 6.4 1.4 6.4 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 8.5 2.5 4.4 1.2 .3 .1 30 52 14 3 1 7.7 3.5 3.0 .6 .5 .0 45 39 8 7 0 8.1 3.0 3.7 .9 .4 .0 38 46 11 5 0 .57 .71 .99 .42 .14 .07 10.6 9.2 4.2 2.8 .7 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 11.4 5.1 5.1 1.1 .0 .0 44 45 10 0 0 10.3 4.3 5.4 .5 .2 .0 42 52 5 2 0 10.8 4.7 5.2 .8 .1 .0 43 48 8 1 0 .78 .57 .21 .42 .14 .00 1.4 4.9 3.5 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 600 APPENDIX 4 Individual Clinical Hematology Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO POLY POIK HYPO TOXNEUT -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05549 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05542 - - - - - Covance 6329-223 3M T-6295.7 601 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.82 13.3 41.2 60.4 19.4 32.2 584 .4 27 6.44 12.5 39.3 61.0 19.4 31.8 337 .2 13 6.63 12.9 40.2 60.7 19.4 32.0 460 .3 .269 .57 1.34 .42 .00 .28 174.7 .14 2 2 2 2 2 2 2 2 20 9.9 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 7.19 14.1 46.3 64.3 19.6 30.5 415 .5 36 7.12 13.8 44.9 63.0 19.4 30.8 566 .1 7 7.16 14.0 45.6 63.7 19.5 30.6 490 .3 .049 .21 .99 .92 .14 .21 106.8 .28 2 2 2 2 2 2 2 2 22 20.5 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 5.93 11.9 38.7 65.3 20.1 30.9 445 1.4 83 6.68 13.2 42.5 63.7 19.8 31.1 576 .0 0 6.30 12.6 40.6 64.5 19.9 31.0 510 .7 .530 .92 2.69 1.13 .21 .14 92.6 .99 2 2 2 2 2 2 2 2 42 58.7 2 602 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 11.2 5.4 4.9 .7 .1 .1 48 44 6 1 1 12.0 7.5 3.8 .6 .1 .0 62 32 5 1 0 11.6 6.4 4.4 .6 .1 .0 55 38 6 1 0 .57 1.48 .78 .07 .00 .07 9.9 8.5 .7 .0 .7 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 10.7 4.1 5.6 .8 .2 .0 38 52 7 2 0 12.5 5.7 6.2 .5 .2 .0 45 49 4 1 0 11.6 4.9 5.9 .6 .2 .0 42 50 6 2 0 1.27 1.13 .42 .21 .00 .00 4.9 2.1 2.1 .7 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 12.0 7.5 3.5 .7 .2 .1 63 29 6 1 1 21.2 13.1 6.0 1.6 .5 .1 62 28 7 3 0 16.6 10.3 4.8 1.2 .4 .1 62 28 6 2 0 6.51 3.96 1.77 .64 .21 .00 .7 .7 .7 1.4 .7 2 2 2 2 2 2 2 2 2 2 2 603 APPENDIX 4 Individual Clinical Hematology Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO POLY POIK HYPO TOXNEUT -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 - - - - - I05526 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05523 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 604 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.63 11.3 34.8 61.8 20.1 32.6 580 .6 34 6.88 13.5 42.2 61.3 19.6 31.9 407 .4 28 6.26 12.4 38.5 61.6 19.8 32.2 494 .5 .884 1.56 5.23 .35 .35 .49 122.3 .14 2 2 2 2 2 2 2 2 31 4.2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.61 12.7 40.2 60.9 19.3 31.7 441 .4 26 6.70 12.7 41.4 61.9 19.0 30.6 461 .2 13 6.66 12.7 40.8 61.4 19.2 31.2 451 .3 .064 .00 .85 .71 .21 .78 14.1 .14 2 2 2 2 2 2 2 2 20 9.2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.62 12.7 40.7 61.4 19.1 31.2 293 .0 0 7.51 13.5 45.2 60.1 18.0 29.9 598 .3 23 7.06 13.1 42.9 60.8 18.5 30.6 446 .2 .629 .57 3.18 .92 .78 .92 215.7 .21 2 2 2 2 2 2 2 2 12 16.3 2 605 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 8.2 4.5 2.9 .6 .2 .0 55 36 7 2 0 9.3 4.3 3.8 .8 .4 .0 46 41 8 4 0 8.8 4.4 3.4 .7 .3 .0 50 38 8 3 0 .78 .14 .64 .14 .14 .00 6.4 3.5 .7 1.4 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 11.1 5.0 4.7 1.0 .4 .0 45 43 9 3 0 8.7 2.6 4.6 .8 .8 .0 29 52 9 9 0 9.9 3.8 4.6 .9 .6 .0 37 48 9 6 0 1.70 1.70 .07 .14 .28 .00 11.3 6.4 .0 4.2 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 9.9 3.5 5.1 1.0 .2 .1 36 51 10 2 1 11.2 2.5 7.3 .9 .4 .2 22 65 8 4 2 10.6 3.0 6.2 1.0 .3 .2 29 58 9 3 2 .92 .71 1.56 .07 .14 .07 9.9 9.9 1.4 1.4 .7 2 2 2 2 2 2 2 2 2 2 2 606 APPENDIX 4 Individual Clinical Hematology Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO POLY POIK HYPO TOXNEUT -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05549 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05542 - - - - - Covance 6329-223 3M T-6295.7 607 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.54 12.6 39.9 61.0 19.2 31.5 503 .7 46 6.59 12.6 41.4 62.8 19.1 30.5 366 .3 20 6.56 12.6 40.7 61.9 19.2 31.0 434 .5 .035 .00 1.06 1.27 .07 .71 96.9 .28 2 2 2 2 2 2 2 2 33 18.4 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.80 13.5 43.6 64.1 19.8 30.9 377 .7 48 7.00 13.8 44.2 63.1 19.8 31.3 369 .7 49 6.90 13.6 43.9 63.6 19.8 31.1 373 .7 .141 .21 .42 .71 .00 .28 5.7 .00 2 2 2 2 2 2 2 2 48 .7 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.42 12.7 43.5 67.6 19.7 29.2 478 .9 58 6.42 12.5 41.3 64.3 19.5 30.3 562 .3 19 6.42 12.6 42.4 66.0 19.6 29.8 520 .6 .000 .14 1.56 2.33 .14 .78 59.4 .42 2 2 2 2 2 2 2 2 38 27.6 2 608 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 7.1 2.0 4.3 .5 .1 .3 28 60 7 1 4 9.6 4.2 4.1 1.1 .1 .0 44 43 11 1 1 8.4 3.1 4.2 .8 .1 .2 36 52 9 1 2 1.77 1.56 .14 .42 .00 .21 11.3 12.0 2.8 .0 2.1 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 8.1 3.8 3.2 .9 .2 .1 47 39 11 2 1 13.7 6.2 6.2 .7 .5 .1 45 45 5 3 1 10.9 5.0 4.7 .8 .4 .1 46 42 8 2 1 3.96 1.70 2.12 .14 .21 .00 1.4 4.2 4.2 .7 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 15.7 10.9 3.4 1.2 .1 .1 70 22 7 1 1 16.2 8.8 5.4 1.3 .4 .3 54 33 8 2 2 16.0 9.8 4.4 1.2 .2 .2 62 28 8 2 2 .35 1.48 1.41 .07 .21 .14 11.3 7.8 .7 .7 .7 2 2 2 2 2 2 2 2 2 2 2 609 APPENDIX 4 Individual Clinical Hematology Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO POLY POIK HYPO TOXNEUT -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 - - - - - I05526 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 - - - - - I05523 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 - - - - - I05522 - - - - - Covance 6329-223 3M T-6295.7 610 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC X106/mcL HGB G/DL -------- -------- HCT % -------- MCV FL -------- MCH PG -------- MCHC % -------- PLT RETIC X103/mcL % -------- -------- RETIC X103/mcL -------- Dose Level: 0 Dosage Unit: mg/kg/day 5.52 11.1 34.6 62.6 20.1 32.1 533 .6 33 6.51 12.6 40.5 62.3 19.4 31.1 483 .3 20 6.02 11.8 37.5 62.5 19.8 31.6 508 .4 .700 1.06 4.17 .21 .49 .71 35.4 .21 2 2 2 2 2 2 2 2 26 9.2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 6.60 12.6 41.2 62.4 19.1 30.7 405 .3 20 6.33 12.0 39.3 62.1 18.9 30.5 408 .6 38 6.46 12.3 40.2 62.2 19.0 30.6 406 .4 .191 .42 1.34 .21 .14 .14 2.1 .21 2 2 2 2 2 2 2 2 29 12.7 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 6.62 12.5 41.0 61.9 18.9 30.5 293 .2 13 6.81 12.3 40.6 59.7 18.1 30.3 500 .4 27 6.72 12.4 40.8 60.8 18.5 30.4 396 .3 .134 .14 .28 1.56 .57 .14 146.4 .14 2 2 2 2 2 2 2 2 20 9.9 2 611 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Hematology Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS WBC X103/mcL N-SEG LYMPH MONO EOSIN BASO N-SEG% X103/mcL X103/mcL X103/mcL X103/mcL X103/mcL -------- -------- -------- -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN% -------- BASO% -------- Dose Level: 0 Dosage Unit: mg/kg/day 6.9 3.5 2.5 .7 .2 .1 50 36 10 2 1 15.6 10.5 3.2 1.3 .4 .2 67 20 9 3 1 11.2 7.0 2.8 1.0 .3 .2 58 28 10 2 1 6.15 4.95 .49 .42 .14 .07 12.0 11.3 .7 .7 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 13.8 7.1 5.1 1.0 .4 .2 51 37 8 3 2 9.2 3.8 3.4 1.1 .7 .2 41 37 12 7 2 11.5 5.4 4.2 1.0 .6 .2 46 37 10 5 2 3.25 2.33 1.20 .07 .21 .00 7.1 .0 2.8 2.8 .0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 9.8 3.2 5.7 .5 .1 .2 33 58 5 1 2 11.0 3.0 7.0 .5 .3 .1 28 64 5 2 1 10.4 3.1 6.4 .5 .2 .2 30 61 5 2 2 .85 .14 .92 .00 .14 .07 3.5 4.2 .0 .7 .7 2 2 2 2 2 2 2 2 2 2 2 612 APPENDIX 4 Individual Clinical Hematology Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ ANISO POLY POIK HYPO TOXNEUT -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 - - - - - I05549 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 - - - - - I05552 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 - - - - - I05542 - - - - - Covance 6329-223 3M T-6295.7 613 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 62 22 1.0 8.7 4.6 4.1 1.3 5 88 71 76 21 1.3 9.2 4.7 4.5 1.0 11 137 92 74 27 1.2 9.3 5.0 4.3 .3 10 174 58 69 17 1.1 8.7 4.9 3.8 .7 9 111 78 75 19 1.1 9.4 5.2 4.2 .3 9 150 63 99 17 1.2 8.8 4.9 3.9 .2 9 170 58 76 20 1.2 9.0 4.9 4.1 .6 12.5 3.8 .10 .32 .21 .26 .45 6 6 6 6 6 6 6 9 138 2.0 33.7 6 6 70 13.3 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 76 17 1.2 9.7 5.5 4.2 .5 9 138 41 69 17 1.0 9.5 4.6 4.9 .2 8 111 48 58 29 1.1 8.8 5.0 3.8 .6 11 98 113 75 16 1.4 10.2 5.6 4.6 .3 8 93 41 70 20 1.2 9.6 5.2 4.4 .4 8.3 6.2 .17 .58 .46 .48 .18 4 4 4 4 4 4 4 9 110 1.4 20.1 4 4 61 35.0 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 59 20 1.2 9.3 5.2 4.1 1.3 14 186 48 138 16 .9 8.8 4.4 4.4 .3 10 157 59 95 22 1.5 10.1 5.3 4.8 .5 9 124 55 76 20 1.1 9.3 5.2 4.1 .3 8 124 53 69 25 1.4 9.6 5.2 4.4 .7 10 141 62 58 24 1.3 9.7 5.2 4.5 .7 8 175 57 82 21 1.2 9.5 5.1 4.4 .6 10 151 56 30.4 3.3 .22 .44 .34 .26 .37 2.2 26.1 4.9 6 6 6 6 6 6 6 6 6 6 614 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 67 18 1.3 9.6 5.1 4.5 .4 10 129 68 102 22 1.4 9.9 5.0 4.9 .4 7 121 58 71 22 1.4 9.5 5.3 4.2 .8 10 117 62 58 21 1.1 8.8 4.7 4.1 1.0 8 115 55 75 22 1.3 9.2 5.3 3.9 .3 10 188 77 64 18 1.3 9.5 5.5 4.0 .3 9 159 83 73 20 1.3 9.4 5.2 4.3 .5 15.4 2.0 .11 .38 .28 .37 .29 6 6 6 6 6 6 6 9 138 1.3 29.3 6 6 67 11.0 6 615 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 58 24 546 152 84 51 628 125 58 33 514 117 36 26 866 88 58 31 1156 211 43 29 556 113 8 1086 451 12 284 9 1908 508 226 325 9 783 448 12 249 4 660 336 17 220 7 1671 250 25 168 6 692 376 37 235 56 16.5 6 32 9.7 6 711 252.6 6 134 42.8 6 7 1133 1.9 535.3 6 6 395 93.4 6 55 84.4 6 247 54.0 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 53 27 642 155 38 43 787 125 43 48 1002 182 43 26 369 103 4 1955 413 4 348 715 2 848 435 3 595 340 19 243 43 441 60 326 17 196 44 6.3 4 36 11.2 4 700 265.6 4 141 34.5 4 3 936 476 1.0 709.0 164.6 4 4 4 35 20.6 4 302 107.4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 66 99 720 194 39 29 814 130 54 34 579 124 99 78 716 82 84 118 1165 154 93 56 624 278 12 670 367 133 190 4 1109 450 15 301 2 1047 326 33 218 16 1549 471 29 291 10 820 469 56 296 5 1329 236 39 156 72 23.5 6 69 35.7 6 770 210.3 6 160 68.4 6 8 1087 5.4 322.3 6 6 386 94.5 6 51 42.4 6 242 62.4 6 616 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 54 49 1443 167 54 94 447 138 80 181 585 156 71 32 927 199 69 48 646 105 80 78 992 259 6 1602 653 9 575 515 6 1265 704 6 540 543 5 907 396 5 1676 362 52 359 19 326 39 435 99 325 15 274 21 224 68 11.7 6 80 54.2 6 840 360.9 6 171 53.3 6 6 1094 1.5 497.4 6 6 529 135.6 6 41 31.8 6 324 72.2 6 617 Appendix 4 Individual Clinical Chemistry Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 10.2 6.5 154 4.9 106 10.3 5.8 154 4.8 106 11.1 6.6 161 5.9 113 10.5 6.1 158 5.7 111 11.8 7.5 166 6.1 111 10.7 5.0 160 4.9 109 MEAN S.D. N 10.8 .60 6 6.2 .84 6 159 4.6 6 5.4 .58 6 109 2.9 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 12.2 6.5 171 6.2 114 11.3 6.9 159 5.8 110 11.1 7.1 159 5.5 109 12.0 6.1 167 6.1 112 MEAN S.D. N 11.6 .53 4 6.6 .44 4 164 6.0 4 5.9 .32 4 111 2.2 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 11.9 5.9 161 5.8 112 10.7 7.5 156 5.8 111 12.2 6.9 169 7.2 113 11.2 6.6 164 6.1 116 11.9 8.8 168 7.0 110 10.9 6.7 158 6.3 108 MEAN S.D. N 11.5 .62 6 7.1 .99 6 163 5.3 6 6.4 .60 6 112 2.7 6 Covance 6329-223 3M T-6295.7 618 Appendix 4 Individual Clinical Chemistry Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 11.8 8.0 165 6.1 112 11.3 6.0 157 6.5 108 10.9 5.9 158 5.5 104 10.5 6.1 156 4.8 106 11.8 7.0 162 5.8 109 11.7 8.3 168 6.3 110 MEAN S.D. N 11.3 .54 6 6.9 1.06 6 161 4.8 6 5.8 .62 6 108 2.9 6 Covance 6329-223 3M T-6295.7 619 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 54 23 1.2 9.4 5.1 4.3 1.2 7 93 56 108 23 1.3 9.9 5.5 4.4 .3 10 168 91 70 23 1.3 8.6 4.6 4.0 .5 7 137 54 51 19 1.3 9.9 4.6 5.3 .5 4 203 131 82 22 1.2 10.8 4.7 6.1 .4 7 133 56 92 21 1.1 9.0 4.9 4.1 .3 7 159 48 76 22 1.2 9.6 4.9 4.7 .5 22.2 1.6 .08 .78 .35 .83 .34 6 6 6 6 6 6 6 7 149 1.9 37.2 6 6 73 32.4 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 71 21 1.3 10.0 4.9 5.1 .5 66 23 1.2 9.2 4.5 4.7 .7 89 22 1.2 8.9 4.6 4.3 .3 67 24 1.1 9.0 4.8 4.2 .6 5 120 68 6 133 69 9 146 55 6 120 56 73 22 1.2 9.3 4.7 4.6 .5 10.7 1.3 .08 .50 .18 .41 .17 4 4 4 4 4 4 4 6 130 1.7 12.4 4 4 62 7.5 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 86 20 1.2 10.7 5.5 5.2 .8 7 162 50 87 21 1.1 9.8 5.2 4.6 .3 7 142 42 82 29 1.3 9.2 3.9 5.3 .6 7 141 66 72 20 1.1 9.1 4.7 4.4 .9 37 156 74 55 21 1.0 9.1 4.4 4.7 .5 11 122 63 74 27 1.1 9.8 4.6 5.2 .6 6 140 53 76 23 1.1 9.6 4.7 4.9 .6 12 144 58 12.0 3.9 .10 .62 .57 .38 .21 12.1 14.0 11.7 6 6 6 6 6 6 6 6 6 6 620 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 106 27 1.3 9.4 4.9 4.5 .4 11 163 69 71 21 1.4 10.1 5.5 4.6 .4 8 149 65 88 17 1.2 10.5 4.6 5.9 .3 9 137 53 74 26 1.1 8.6 4.4 4.2 .4 8 164 37 71 25 1.3 8.8 4.6 4.2 .5 9 152 86 60 26 .9 8.8 4.5 4.3 1.3 7 158 56 78 24 1.2 9.4 4.8 4.6 .6 16.3 3.9 .18 .78 .40 .65 .37 6 6 6 6 6 6 6 9 154 1.4 10.1 6 6 61 16.6 6 621 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 66 202 195 101 65 211 274 121 75 215 217 98 61 48 550 163 61 82 256 204 55 83 254 50 3 484 425 5 1588 281 7 792 360 5 872 314 3 896 595 3 1242 272 27 265 39 135 46 211 12 184 27 342 19 185 64 6.7 6 140 76.9 6 291 130.1 6 123 54.0 6 4 979 374 1.6 384.3 121.9 6 6 6 28 12.5 6 220 73.1 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 68 89 200 166 54 146 184 72 44 80 210 62 50 98 211 75 2 706 219 3 395 293 3 477 433 4 356 566 25 152 12 189 17 286 48 322 54 10.2 4 103 29.4 4 201 12.5 4 94 48.5 4 3 484 378 .8 156.7 153.7 4 4 4 26 15.9 4 237 79.9 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 77 76 201 127 68 135 454 120 39 65 122 64 140 160 198 41 74 143 334 80 48 78 232 91 2 1192 366 4 1003 411 2 362 269 8 663 484 6 1073 352 3 769 617 35 177 46 230 44 179 25 272 0 210 62 393 74 35.5 6 110 41.0 6 257 118.5 6 87 32.9 6 4 844 416 2.4 306.4 121.0 6 6 6 35 21.2 6 244 81.3 6 622 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 101 216 301 121 63 88 329 64 68 148 575 63 57 126 182 52 74 99 204 79 67 63 269 70 5 3858 411 3 902 545 7 2229 336 4 417 380 3 1377 294 1 964 337 25 269 0 343 15 205 39 223 31 196 4 246 72 15.4 6 123 54.2 6 310 141.4 6 75 24.3 6 4 1624 2.0 1251.5 6 6 384 88.6 6 19 15.4 6 247 54.1 6 623 Appendix 4 Individual Clinical Chemistry Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 10.9 5.8 155 5.6 106 13.0 6.5 173 8.0 119 10.4 5.6 159 5.4 110 12.4 7.1 166 6.4 116 11.5 6.8 167 6.0 118 10.3 5.7 156 5.7 112 MEAN S.D. N 11.4 1.10 6 6.2 .63 6 163 7.1 6 6.2 .96 6 114 5.0 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 10.9 4.4 165 5.2 113 11.7 3.8 164 6.5 117 10.3 4.4 158 5.4 112 10.8 6.1 165 6.5 119 MEAN S.D. N 10.9 .58 4 4.7 .99 4 163 3.4 4 5.9 .70 4 115 3.3 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 11.5 6.2 167 6.4 113 11.5 5.6 164 6.3 116 10.5 6.1 164 6.3 118 10.3 4.9 156 5.3 111 10.6 5.3 152 5.5 112 11.6 7.1 166 7.0 118 MEAN S.D. N 11.0 .59 6 5.9 .78 6 162 6.1 6 6.1 .63 6 115 3.1 6 Covance 6329-223 3M T-6295.7 624 Appendix 4 Individual Clinical Chemistry Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 10.9 5.1 163 5.1 114 11.6 5.7 164 6.3 112 12.1 5.7 168 6.0 115 10.7 6.1 159 6.8 116 11.7 4.7 167 7.1 115 10.7 5.6 155 5.3 113 MEAN S.D. N 11.3 .59 6 5.5 .50 6 163 4.9 6 6.1 .80 6 114 1.5 6 Covance 6329-223 3M T-6295.7 625 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 54 20 1.1 9.2 4.8 4.4 1.4 8 118 70 68 19 1.2 9.9 4.8 5.1 1.1 11 171 85 57 26 1.1 8.5 4.5 4.0 .4 9 161 45 62 19 1.0 8.7 4.8 3.9 .9 7 117 90 54 19 .9 8.4 4.6 3.8 .4 10 134 48 65 16 1.2 8.8 4.8 4.0 .4 8 139 74 60 20 1.1 8.9 4.7 4.2 .8 5.9 3.3 .12 .56 .13 .49 .43 6 6 6 6 6 6 6 9 140 1.5 22.1 6 6 69 18.7 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 65 22 1.4 10.0 5.7 4.3 .6 72 14 1.1 9.9 4.8 5.1 .2 58 21 1.0 7.8 4.7 3.1 .4 53 16 1.3 9.5 4.9 4.6 .4 9 148 51 7 132 45 8 108 50 6 83 41 62 18 1.2 9.3 5.0 4.3 .4 8.3 3.9 .18 1.02 .46 .85 .16 4 4 4 4 4 4 4 8 118 1.3 28.4 4 4 47 4.6 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 52 17 1.1 9.0 5.0 4.0 1.0 62 17 .8 9.0 4.7 4.3 .3 71 19 1.4 9.7 4.9 4.8 .4 68 18 1.1 9.3 5.2 4.1 .3 68 26 1.4 8.8 4.5 4.3 .6 47 28 1.1 9.4 4.7 4.7 .7 7 176 50 7 159 54 8 135 61 8 116 65 7 134 59 9 155 56 61 21 1.2 9.2 4.8 4.4 .6 9.8 4.9 .23 .33 .25 .32 .27 6 6 6 6 6 6 6 8 146 .8 21.5 6 6 58 5.3 6 626 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 58 20 1.4 9.1 4.9 4.2 .5 75 24 1.4 9.4 5.0 4.4 .3 66 19 1.3 9.9 5.4 4.5 .4 54 21 1.1 9.3 4.5 4.8 .7 64 23 1.2 8.8 5.1 3.7 .2 71 18 1.3 9.4 5.5 3.9 .4 8 112 109 6 109 72 6 127 68 5 130 62 8 156 108 9 143 128 65 21 1.3 9.3 5.1 4.2 .4 7.8 2.3 .12 .37 .36 .40 .17 6 6 6 6 6 6 6 7 130 1.5 18.0 6 6 91 27.3 6 627 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 37 30 776 159 4 173 482 21 288 53 59 605 130 7 170 268 23 155 46 28 690 112 11 231 451 12 235 26 23 876 77 5 99 349 11 223 35 27 1552 203 9 160 235 17 152 71 69 830 126 7 1291 462 45 278 45 15.9 6 39 19.5 6 888 339.5 6 134 42.9 6 7 354 374 2.6 461.0 106.3 6 6 6 22 12.5 6 222 58.4 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 30 23 855 144 38 53 999 104 35 36 1284 153 45 46 365 77 2 169 440 4 137 666 2 186 421 5 273 310 14 252 44 391 18 314 20 171 37 6.3 4 40 13.0 4 876 384.3 4 120 35.4 4 3 191 459 1.5 58.2 149.3 4 4 4 24 13.6 4 282 93.3 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 55 58 721 154 10 176 339 29 163 25 20 1042 127 1 138 451 6 295 46 38 733 117 3 140 339 61 212 35 45 878 73 6 143 436 39 264 54 91 1359 103 6 222 407 42 238 70 45 643 239 3 287 240 65 155 48 15.9 6 50 23.8 6 896 267.3 6 136 57.3 6 5 184 369 3.2 59.7 78.9 6 6 6 40 21.7 6 221 55.5 6 628 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 29 20 1772 149 33 35 564 112 54 87 967 169 46 36 798 138 50 43 808 85 48 54 1069 197 3 154 675 2 164 536 2 436 626 2 143 539 2 329 348 2 473 409 38 341 9 329 21 380 35 311 20 236 30 247 43 10.0 6 46 23.0 6 996 417.0 6 142 39.9 6 2 283 522 .4 149.7 124.7 6 6 6 26 10.9 6 307 55.9 6 629 Appendix 4 Individual Clinical Chemistry Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 10.3 7.0 161 5.4 114 11.0 6.7 163 5.8 115 10.6 7.0 155 5.3 112 10.5 6.8 158 5.2 115 10.4 7.4 159 5.2 114 10.7 5.1 165 5.8 122 MEAN S.D. N 10.6 .25 6 6.7 .80 6 160 3.6 6 5.4 .28 6 115 3.4 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 12.9 9.0 180 6.6 121 10.8 6.8 162 6.2 114 10.5 6.5 160 5.1 116 10.7 5.2 158 5.2 111 MEAN S.D. N 11.2 1.12 4 6.9 1.58 4 165 10.1 4 5.8 .74 4 116 4.2 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 11.2 5.4 159 5.1 114 11.2 7.4 161 5.3 116 11.4 6.4 162 5.6 114 10.9 6.9 163 6.1 116 10.4 8.3 163 5.8 115 10.6 6.3 155 5.9 115 MEAN S.D. N 11.0 .39 6 6.8 1.00 6 160 3.1 6 5.6 .38 6 115 .9 6 Covance 6329-223 3M T-6295.7 630 Appendix 4 Individual Clinical Chemistry Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 10.6 7.8 164 5.1 119 10.6 5.1 158 5.1 111 10.9 6.1 162 5.4 115 10.6 5.2 157 5.8 114 11.3 7.8 162 5.5 114 11.6 7.6 166 5.7 113 MEAN S.D. N 10.9 .43 6 6.6 1.29 6 162 3.4 6 5.4 .29 6 114 2.7 6 Covance 6329-223 3M T-6295.7 631 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 50 21 .9 9.2 4.5 4.7 1.1 86 25 1.3 9.0 4.8 4.2 .4 57 25 1.2 8.5 4.4 4.1 .8 43 16 1.1 9.6 4.0 5.6 .3 59 27 1.1 10.6 4.5 6.1 .6 55 18 .9 9.1 4.5 4.6 .2 8 106 64 8 154 56 7 160 65 7 183 123 8 127 63 8 151 56 58 22 1.1 9.3 4.4 4.9 .6 14.7 4.4 .16 .71 .26 .80 .34 6 6 6 6 6 6 6 8 147 .5 26.9 6 6 71 25.7 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 87 20 1.1 9.1 4.4 4.7 .4 5 114 60 65 22 1.1 9.3 4.4 4.9 .8 10 130 78 65 18 1.0 8.4 4.4 4.0 .2 10 137 50 50 25 1.1 9.2 4.7 4.5 .5 10 116 69 67 21 1.1 9.0 4.5 4.5 .5 15.2 3.0 .05 .41 .15 .39 .25 4 4 4 4 4 4 4 9 124 2.5 11.1 4 4 64 12.0 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 53 22 1.0 9.4 4.4 5.0 .7 8 146 60 60 21 1.0 9.0 4.7 4.3 .4 7 105 36 72 15 1.1 9.0 3.9 5.1 .7 7 149 65 64 17 1.0 9.4 4.7 4.7 .6 15 162 66 48 20 1.0 8.9 4.0 4.9 .4 7 114 54 60 25 1.0 9.5 4.0 5.5 .5 7 123 63 60 20 1.0 9.2 4.3 4.9 .6 8.4 3.6 .04 .26 .37 .40 .14 6 6 6 6 6 6 6 8 133 3.2 22.4 6 6 57 11.3 6 632 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 86 27 1.1 9.2 4.3 4.9 .3 70 19 1.3 9.1 4.3 4.8 .3 77 15 1.1 9.6 4.3 5.3 .3 58 21 1.0 9.0 4.5 4.5 .4 74 30 1.2 8.7 4.5 4.2 .4 56 22 .9 8.9 4.4 4.5 .7 9 136 68 6 130 59 7 102 51 6 121 61 7 138 110 6 113 46 70 22 1.1 9.1 4.4 4.7 .4 11.5 5.4 .14 .31 .10 .38 .15 6 6 6 6 6 6 6 7 123 1.2 14.1 6 6 66 23.0 6 633 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 28 36 209 88 54 108 400 98 33 51 330 80 44 38 583 138 44 38 351 164 60 85 298 44 3 109 376 9 205 244 4 156 326 7 180 332 3 274 494 5 518 263 14 232 27 107 38 188 11 186 18 279 0 169 44 12.1 6 59 30.2 6 362 125.6 6 102 42.9 6 5 240 339 2.4 146.6 89.9 6 6 6 18 13.2 6 194 58.2 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 49 73 210 170 68 81 257 65 29 51 193 54 49 76 301 64 3 287 254 2 761 344 3 165 423 5 301 514 24 168 15 218 23 273 50 290 49 15.9 4 70 13.3 4 240 48.7 4 88 54.7 4 3 378 384 1.3 262.2 110.9 4 4 4 28 15.2 4 237 55.5 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 33 35 286 103 41 69 459 90 26 49 130 73 45 125 219 43 35 70 423 70 38 60 396 76 1 206 364 4 121 387 2 110 305 2 267 533 5 123 317 4 363 580 41 172 50 200 36 198 41 282 0 179 36 350 36 6.6 6 68 30.9 6 319 129.0 6 76 20.3 6 3 198 414 1.5 101.3 115.1 6 6 6 34 17.4 6 230 70.7 6 634 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 34 56 305 95 37 35 543 37 42 49 743 52 37 50 269 46 22 40 296 61 45 46 332 60 1 153 404 2 766 485 2 352 341 3 413 394 3 130 233 1 174 383 32 261 15 298 20 203 27 215 24 119 21 284 36 8.0 6 46 7.5 6 415 188.9 6 58 20.0 6 2 331 373 .9 242.1 83.3 6 6 6 23 5.9 6 230 66.0 6 635 Appendix 4 Individual Clinical Chemistry Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 10.5 6.8 151 5.3 108 10.8 5.6 163 6.0 111 9.7 5.0 165 6.2 120 10.6 5.6 161 5.9 117 10.6 6.4 162 5.4 115 10.2 5.0 162 5.4 117 MEAN S.D. N 10.4 .39 6 5.7 .73 6 161 4.9 6 5.7 .38 6 115 4.4 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 9.9 4.7 154 4.0 110 10.7 4.3 166 6.2 118 9.8 3.8 159 5.1 117 10.4 4.2 164 5.5 120 MEAN S.D. N 10.2 .42 4 4.2 .37 4 161 5.4 4 5.2 .92 4 116 4.3 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 9.2 5.5 159 5.0 113 10.0 4.9 154 5.3 114 8.5 5.2 156 5.3 114 10.5 4.0 160 5.0 116 9.7 4.9 155 4.8 113 10.2 5.9 159 5.9 114 MEAN S.D. N 9.7 .73 6 5.1 .65 6 157 2.5 6 5.2 .39 6 114 1.1 6 Covance 6329-223 3M T-6295.7 636 Appendix 4 Individual Clinical Chemistry Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 10.0 5.4 152 5.6 114 10.5 4.1 162 5.9 117 10.6 4.9 161 5.9 117 10.5 5.1 158 6.3 115 10.7 5.4 168 6.3 122 10.3 4.9 158 5.2 114 MEAN S.D. N 10.4 .25 6 5.0 .48 6 160 5.3 6 5.9 .42 6 116 3.0 6 Covance 6329-223 3M T-6295.7 637 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 51 21 1.1 9.1 4.7 4.4 1.3 8 132 67 71 17 1.2 9.3 4.8 4.5 1.0 11 179 97 54 26 1.1 8.4 4.7 3.7 .4 11 178 44 56 16 1.0 8.3 4.4 3.9 .8 8 124 63 52 22 1.0 8.1 4.7 3.4 .3 8 147 48 70 17 1.1 8.2 4.4 3.8 .3 10 158 56 59 20 1.1 8.6 4.6 4.0 .7 9.1 3.9 .08 .50 .17 .42 .42 6 6 6 6 6 6 6 9 153 1.5 23.0 6 6 62 19.0 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 56 18 1.2 8.6 4.9 3.7 .5 13 142 57 62 17 1.3 9.9 4.8 5.1 .4 8 129 73 61 25 1.0 8.4 4.2 4.2 .3 10 98 71 57 18 1.3 9.3 5.0 4.3 .3 9 89 41 59 20 1.2 9.0 4.7 4.3 .4 10 114 60 2.9 3.7 .14 .69 .36 .58 .10 2.2 25.1 14.8 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 58 16 1.1 8.8 4.9 3.9 .9 9 183 53 59 14 .8 8.1 4.1 4.0 .3 8 145 57 83 16 1.3 9.0 4.8 4.2 .3 10 142 48 84 19 1.2 9.0 5.4 3.6 .3 13 130 55 62 22 1.3 8.4 4.4 4.0 .5 10 135 46 54 24 1.2 9.2 4.3 4.9 .5 9 132 83 67 18 1.2 8.8 4.6 4.1 .5 10 144 57 13.3 3.9 .19 .42 .48 .44 .23 1.7 19.7 13.4 6 6 6 6 6 6 6 6 6 6 638 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 68 18 1.3 8.2 4.4 3.8 .3 10 106 70 95 23 1.4 9.1 4.5 4.6 .3 8 104 81 71 18 1.2 9.3 5.1 4.2 .3 14 117 62 67 17 1.1 8.8 4.3 4.5 .4 6 125 56 71 22 1.4 8.4 4.9 3.5 .2 11 144 96 70 17 1.2 8.8 5.7 3.1 .3 9 155 94 74 19 1.3 8.8 4.8 4.0 .3 10 125 76 10.6 2.6 .12 .41 .53 .59 .06 2.7 20.6 16.6 6 6 6 6 6 6 6 6 6 6 639 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 34 24 709 154 44 47 512 102 45 27 742 125 24 21 848 77 33 27 1455 209 33 59 767 114 4 116 510 8 144 280 9 148 448 5 82 365 9 143 197 5 156 428 18 312 47 168 9 235 11 241 20 133 27 256 36 7.9 6 34 15.2 6 839 321.9 6 130 46.2 6 7 132 371 2.3 27.8 115.8 6 6 6 22 13.9 6 224 64.2 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 26 16 634 121 43 57 955 109 38 40 1125 147 34 28 287 87 5 93 359 5 173 641 2 201 383 5 129 331 11 214 38 390 9 295 27 182 35 7.2 4 35 17.5 4 750 369.9 4 116 25.0 4 4 149 428 1.5 47.7 143.3 4 4 4 21 13.8 4 270 92.9 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 44 41 643 143 10 127 305 14 155 23 20 980 134 1 157 442 0 294 38 31 698 109 3 133 327 32 216 41 40 798 80 6 175 436 24 268 49 55 1181 106 9 152 354 23 212 47 33 535 194 2 173 203 26 135 40 9.4 6 37 11.7 6 806 237.8 6 128 39.4 6 5 153 344 3.8 19.9 89.3 6 6 6 20 11.3 6 213 61.7 6 640 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 26 28 1502 139 27 31 462 96 36 64 626 127 43 38 683 127 34 34 725 89 35 63 941 171 4 155 657 2 163 496 2 300 593 2 169 516 3 189 340 3 244 390 38 349 14 312 15 367 20 299 8 237 40 243 34 6.3 6 43 16.2 6 823 367.0 6 125 29.9 6 3 203 499 .8 57.2 119.4 6 6 6 22 13.4 6 301 53.4 6 641 Appendix 4 Individual Clinical Chemistry Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 10.0 6.8 159 4.7 116 10.8 6.9 161 5.7 118 10.6 7.6 157 5.7 121 10.0 6.4 158 5.4 120 10.9 8.2 159 5.0 121 10.3 6.8 165 5.8 123 MEAN S.D. N 10.4 .39 6 7.1 .66 6 160 2.9 6 5.4 .44 6 120 2.5 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 10.0 6.8 160 5.1 117 11.0 7.2 185 7.0 136 10.3 7.5 159 5.2 116 10.7 5.5 161 5.2 120 MEAN S.D. N 10.5 .44 4 6.8 .88 4 166 12.5 4 5.6 .92 4 122 9.3 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 10.6 5.3 158 4.9 121 10.1 7.4 154 4.9 115 10.7 6.6 161 6.1 120 10.4 7.2 162 5.1 121 10.2 7.8 161 5.8 120 10.1 5.3 164 5.3 126 MEAN S.D. N 10.4 .26 6 6.6 1.08 6 160 3.5 6 5.4 .50 6 120 3.5 6 Covance 6329-223 3M T-6295.7 642 Appendix 4 Individual Clinical Chemistry Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 10.0 7.6 159 5.3 121 10.3 6.2 153 5.6 118 10.1 5.9 158 5.3 121 10.1 5.1 152 4.7 115 11.1 8.7 163 6.5 123 11.4 7.3 169 6.0 120 MEAN S.D. N 10.5 .60 6 6.8 1.31 6 159 6.4 6 5.6 .63 6 120 2.8 6 Covance 6329-223 3M T-6295.7 643 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 51 18 .9 8.5 4.4 4.1 .9 8 93 59 69 22 1.2 8.6 4.5 4.1 .3 9 152 59 61 25 1.2 8.5 4.5 4.0 .7 8 176 61 47 16 1.2 9.5 4.2 5.3 .4 9 227 185 67 24 1.2 9.8 4.0 5.8 .6 9 126 79 46 22 1.0 9.3 4.5 4.8 .3 10 156 70 57 21 1.1 9.0 4.4 4.7 .5 10.2 3.5 .13 .57 .21 .75 .24 6 6 6 6 6 6 6 9 155 .8 45.4 6 6 86 49.4 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 92 19 1.1 9.2 4.4 4.8 .4 7 126 87 62 23 1.1 9.2 4.2 5.0 .8 8 130 99 58 19 1.0 8.3 4.3 4.0 .3 15 140 50 54 26 1.1 8.7 4.4 4.3 .8 12 113 68 66 22 1.1 8.8 4.3 4.5 .6 10 127 76 17.3 3.4 .05 .44 .10 .46 .26 3.7 11.2 21.5 4 4 4 4 4 4 4 4 4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 53 20 1.2 9.2 4.7 4.5 .8 10 148 58 60 20 1.0 9.1 4.6 4.5 .4 9 113 33 76 18 1.1 8.9 4.0 4.9 .8 6 153 86 79 16 .9 9.0 4.4 4.6 .4 15 153 62 48 20 1.0 8.8 4.0 4.8 .5 13 112 75 57 24 1.0 9.1 4.0 5.1 .6 9 145 68 62 20 1.0 9.0 4.3 4.7 .6 10 137 64 12.6 2.7 .10 .15 .33 .24 .18 3.2 19.5 18.0 6 6 6 6 6 6 6 6 6 6 644 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 88 19 1.2 8.8 4.4 4.4 .3 9 139 53 73 20 1.4 9.5 4.7 4.8 .5 9 142 63 75 14 1.2 9.6 4.3 5.3 .2 9 101 56 68 18 1.1 9.0 4.5 4.5 .4 12 148 78 74 19 1.2 8.5 4.2 4.3 .3 6 120 68 69 29 1.0 8.7 4.4 4.3 .4 8 111 50 74 20 1.2 9.0 4.4 4.6 .4 7.2 5.0 .13 .44 .17 .39 .10 6 6 6 6 6 6 6 9 127 1.9 18.9 6 6 61 10.5 6 645 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 35 49 245 86 38 49 331 92 32 45 321 83 39 39 665 170 41 49 290 159 40 86 308 48 2 182 352 6 226 272 5 490 346 6 294 330 2 245 498 4 138 251 11 219 5 118 38 201 5 191 26 286 0 170 38 3.4 6 53 16.7 6 360 152.5 6 106 47.7 6 4 262 342 1.8 123.6 86.9 6 6 6 14 14.7 6 198 55.5 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 55 77 241 150 41 98 239 67 33 60 186 53 51 73 297 66 3 316 244 2 334 296 4 182 410 7 270 483 27 166 0 196 12 270 38 280 45 9.9 4 77 15.8 4 241 45.3 4 84 44.5 4 4 276 358 2.2 67.9 108.3 4 4 4 19 16.7 4 228 55.8 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 35 31 233 99 46 87 451 89 29 43 129 72 48 105 202 39 33 41 428 68 33 54 386 81 2 302 365 5 124 381 3 121 271 4 253 528 4 142 310 4 224 605 41 172 35 208 30 180 11 283 0 182 53 380 37 7.8 6 60 29.3 6 305 134.0 6 75 20.8 6 4 194 410 1.0 76.1 129.7 6 6 6 28 19.6 6 234 82.3 6 646 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 29 39 285 96 35 41 506 39 31 44 755 52 31 52 240 48 19 33 250 52 43 42 351 62 2 172 414 2 285 503 1 204 340 2 483 434 2 113 241 2 200 377 30 271 41 317 23 204 34 240 18 161 15 283 31 7.8 6 42 6.2 6 398 200.5 6 58 20.0 6 2 243 385 .4 130.1 89.4 6 6 6 27 9.9 6 246 56.7 6 647 Appendix 4 Individual Clinical Chemistry Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 9.7 5.9 151 4.7 114 9.6 6.2 159 6.3 114 10.4 5.9 166 6.0 123 10.3 6.5 167 6.1 125 9.9 5.7 160 5.5 119 10.3 5.5 168 6.0 125 MEAN S.D. N 10.0 .34 6 6.0 .36 6 162 6.5 6 5.8 .59 6 120 5.1 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 9.7 4.8 159 4.9 120 10.2 4.2 163 5.6 119 10.0 4.4 156 4.8 118 9.8 4.8 160 5.6 123 MEAN S.D. N 9.9 .22 4 4.6 .30 4 160 2.9 4 5.2 .43 4 120 2.2 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 9.7 5.2 166 6.5 127 10.0 4.8 156 5.4 121 8.8 5.3 160 5.6 127 10.1 4.3 158 5.5 121 9.9 5.2 158 4.7 122 9.4 5.8 162 5.1 121 MEAN S.D. N 9.6 .48 6 5.1 .51 6 160 3.6 6 5.5 .60 6 123 3.0 6 Covance 6329-223 3M T-6295.7 648 Appendix 4 Individual Clinical Chemistry Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 9.9 5.0 157 5.4 118 10.8 4.6 163 6.9 121 11.0 5.1 160 6.2 119 9.4 5.2 157 5.8 121 10.4 4.7 164 5.1 119 10.0 5.4 165 5.3 123 MEAN S.D. N 10.2 .60 6 5.0 .30 6 161 3.5 6 5.8 .67 6 120 1.8 6 Covance 6329-223 3M T-6295.7 649 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 53 19 1.0 8.7 4.7 4.0 1.2 64 19 1.3 9.1 4.8 4.3 1.1 57 29 1.1 8.3 4.7 3.6 .5 54 19 1.0 8.4 4.7 3.7 .8 56 17 1.1 8.3 4.8 3.5 .3 74 20 1.3 9.2 5.0 4.2 .4 6 119 61 8 177 101 9 170 56 8 132 81 7 151 43 9 177 66 60 20 1.1 8.7 4.8 3.9 .7 8.0 4.3 .14 .40 .12 .33 .38 6 6 6 6 6 6 6 8 154 1.2 24.6 6 6 68 20.4 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 57 19 1.2 9.0 5.1 3.9 .6 74 14 1.2 10.3 5.2 5.1 .3 64 26 1.1 8.5 5.1 3.4 .4 59 19 1.6 10.5 5.9 4.6 .4 7 143 51 8 132 60 7 109 64 8 119 42 64 20 1.3 9.6 5.3 4.2 .4 7.6 4.9 .22 .98 .39 .75 .13 4 4 4 4 4 4 4 8 126 .6 14.9 4 4 54 9.8 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 65 15 1.2 8.7 5.1 3.6 .8 8 173 49 70 14 1.0 9.0 4.9 4.1 .3 6 163 56 108 19 1.3 9.0 5.0 4.0 .2 8 125 38 78 16 1.0 9.1 5.2 3.9 .3 9 139 48 75 26 1.4 8.8 4.8 4.0 .5 14 136 68 53 22 1.2 9.2 5.0 4.2 .5 8 161 44 75 19 1.2 9.0 5.0 4.0 .4 18.5 4.6 .16 .19 .14 .21 .22 6 6 6 6 6 6 6 9 150 2.7 18.8 6 6 50 10.4 6 650 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 63 20 1.6 9.5 5.5 4.0 .3 9 107 88 111 21 1.6 9.8 5.1 4.7 .2 8 80 57 75 18 1.3 9.8 5.4 4.4 .3 17 90 59 62 18 1.1 9.0 4.7 4.3 .3 9 105 56 63 20 1.4 9.0 5.3 3.7 .2 10 147 68 65 18 1.3 9.5 5.5 4.0 .3 7 141 108 73 19 1.4 9.4 5.2 4.2 .3 10 112 73 19.1 1.3 .19 .36 .31 .35 .05 3.6 27.0 21.0 6 6 6 6 6 6 6 6 6 6 651 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 41 25 706 152 4 222 525 18 359 48 45 533 102 6 164 275 23 184 46 31 782 130 11 166 437 0 261 27 24 901 82 7 120 377 20 275 36 24 1408 226 9 167 251 53 186 36 63 863 126 5 168 487 84 325 39 7.7 6 35 15.8 6 866 296.2 6 136 50.1 6 7 168 392 2.6 32.4 111.8 6 6 6 33 30.3 6 265 71.2 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 26 16 692 127 35 38 824 113 37 46 1306 181 43 142 335 104 5 130 386 10 254 4 153 741 134 492 2 189 396 30 322 5 227 338 18 205 35 7.0 4 60 55.8 4 789 401.7 4 131 34.5 4 4 175 465 1.4 42.5 185.6 4 4 4 48 57.9 4 318 125.4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 46 39 710 143 11 164 356 38 200 25 21 1097 160 1 137 501 5 365 41 37 645 111 4 140 324 25 240 34 38 724 76 11 129 454 25 306 45 87 1271 108 4 194 394 12 266 61 49 660 244 3 220 235 56 174 42 12.2 6 45 22.4 6 851 265.3 6 140 58.6 6 6 164 377 4.3 36.2 94.9 6 6 6 27 18.3 6 258 70.1 6 652 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 29 21 1624 154 30 34 463 108 40 75 563 122 43 35 566 118 31 34 726 95 41 65 900 166 3 133 730 2 174 556 2 305 409 1 204 345 2 157 353 2 308 414 63 433 18 381 26 417 35 320 15 263 38 287 36 6.3 6 44 21.0 6 807 428.6 6 127 27.4 6 2 214 468 .6 75.7 149.1 6 6 6 32 17.5 6 350 70.4 6 653 Appendix 4 Individual Clinical Chemistry Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 9.7 6.9 158 4.7 115 11.0 6.3 160 5.1 117 9.8 6.6 154 4.7 112 10.2 6.7 156 5.2 114 9.5 6.9 159 4.9 119 11.4 7.4 174 6.2 127 MEAN S.D. N 10.3 .77 6 6.8 .37 6 160 7.1 6 5.1 .56 6 117 5.3 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 9.8 6.9 163 4.6 117 10.1 6.7 173 6.8 125 10.6 7.5 163 5.1 117 11.6 5.8 169 6.4 123 MEAN S.D. N 10.5 .79 4 6.7 .70 4 167 4.9 4 5.7 1.04 4 120 4.1 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 11.0 5.8 160 4.8 117 11.4 8.2 169 5.6 129 10.0 6.6 159 5.3 115 10.7 6.5 160 5.7 122 10.4 8.0 162 5.7 110 10.3 5.8 155 5.3 112 MEAN S.D. N 10.6 .51 6 6.8 1.05 6 161 4.6 6 5.4 .35 6 118 7.0 6 Covance 6329-223 3M T-6295.7 654 Appendix 4 Individual Clinical Chemistry Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 10.7 7.1 170 5.1 125 11.2 6.7 160 5.8 114 10.4 5.6 158 5.1 117 10.3 5.0 158 5.0 116 11.2 6.6 163 5.2 115 11.1 7.5 167 6.1 114 MEAN S.D. N 10.8 .41 6 6.4 .94 6 163 5.0 6 5.4 .45 6 117 4.2 6 Covance 6329-223 3M T-6295.7 655 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 48 20 1.0 8.8 4.7 4.1 .7 8 99 65 78 22 1.3 9.8 5.4 4.4 .3 6 189 65 95 21 1.2 8.5 4.5 4.0 .4 10 182 61 58 15 1.2 9.4 4.4 5.0 .3 7 217 88 78 22 1.1 9.7 4.4 5.3 .5 9 136 57 42 18 1.1 9.3 4.7 4.6 .3 9 171 65 66 20 1.2 9.2 4.7 4.6 .4 20.5 2.7 .10 .51 .38 .51 .16 6 6 6 6 6 6 6 8 166 1.5 42.0 6 6 67 10.9 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 81 18 1.1 9.0 4.7 4.3 .3 7 114 53 51 22 1.2 9.8 4.7 5.1 .9 7 143 81 61 22 1.0 8.1 4.3 3.8 .4 8 149 50 80 26 1.1 9.0 4.6 4.4 .4 10 129 60 68 22 1.1 9.0 4.6 4.4 .5 14.7 3.3 .08 .69 .19 .54 .27 4 4 4 4 4 4 4 8 134 1.4 15.6 4 4 61 14.0 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 62 15 1.1 9.2 4.8 4.4 .6 7 153 42 55 20 1.1 9.3 4.9 4.4 .3 7 122 35 74 18 1.0 8.7 3.8 4.9 .4 8 143 77 49 24 1.0 8.9 4.6 4.3 .5 22 151 67 45 17 1.0 9.0 4.3 4.7 .4 10 125 43 74 26 1.0 9.3 4.2 5.1 .4 8 143 72 60 20 1.0 9.1 4.4 4.6 .4 10 140 56 12.4 4.2 .05 .24 .41 .32 .10 5.8 13.1 18.0 6 6 6 6 6 6 6 6 6 6 656 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 84 22 1.2 9.8 4.8 5.0 .3 9 142 62 89 18 1.4 9.5 5.0 4.5 .3 6 131 76 89 14 1.2 9.6 4.5 5.1 .3 6 65 51 63 20 1.4 10.0 5.2 4.8 .3 13 105 53 93 32 1.3 9.1 4.5 4.6 .3 7 115 78 56 26 .9 8.8 4.6 4.2 .5 24 109 42 79 22 1.2 9.5 4.8 4.7 .3 11 111 60 15.5 6.3 .19 .45 .29 .33 .08 7.0 26.6 14.4 6 6 6 6 6 6 6 6 6 6 657 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 36 55 220 81 57 78 322 123 35 43 292 84 53 38 583 161 40 38 274 164 44 74 284 50 3 188 387 9 1481 292 6 128 410 7 2407 350 5 146 510 4 368 269 8 264 0 144 45 259 10 224 25 327 0 198 44 9.1 6 54 17.9 6 329 128.7 6 110 46.5 6 6 786 370 2.2 947.2 87.4 6 6 6 15 17.5 6 236 62.7 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 39 72 219 220 39 80 238 73 30 50 168 53 64 114 307 67 2 247 269 2 250 348 3 165 454 11 217 487 23 190 2 249 23 330 25 306 43 14.6 4 79 26.6 4 233 57.5 4 103 78.3 4 4 220 390 4.4 39.4 99.8 4 4 4 18 10.9 4 269 62.5 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 30 34 235 98 37 57 531 85 23 52 157 69 56 153 229 42 38 54 404 68 40 54 390 82 1 196 447 130 245 4 149 426 41 261 3 107 290 26 213 2 345 520 25 319 7 230 329 0 214 7 227 640 18 443 37 11.1 6 67 42.8 6 324 140.3 6 74 19.2 6 4 209 442 2.5 81.8 127.6 6 6 6 40 46.1 6 282 87.7 6 658 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 35 43 296 106 38 34 447 43 33 42 668 54 31 41 294 52 20 40 280 58 50 71 346 63 1 1132 389 1 476 482 2 367 343 2 141 480 2 105 225 2 276 353 35 281 0 338 18 221 35 292 16 169 12 279 34 9.8 6 45 13.0 6 388 150.1 6 63 22.3 6 2 416 379 .5 377.0 96.5 6 6 6 19 13.6 6 263 59.4 6 659 Appendix 4 Individual Clinical Chemistry Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 10.2 5.5 151 5.0 109 11.1 6.0 168 6.7 125 10.3 4.8 160 5.1 116 11.0 6.8 166 5.7 125 8.1 5.6 160 4.8 118 10.7 5.5 162 6.1 117 MEAN S.D. N 10.2 1.11 6 5.7 .66 6 161 5.9 6 5.6 .74 6 118 6.1 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 9.7 4.5 156 4.6 110 11.5 3.6 170 6.5 122 8.8 4.5 154 4.5 113 10.9 4.0 165 5.4 124 MEAN S.D. N 10.2 1.21 4 4.2 .44 4 161 7.5 4 5.2 .93 4 117 6.8 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 9.7 5.4 160 5.2 116 10.7 5.0 161 6.2 121 9.2 5.4 156 5.3 116 10.1 4.1 156 5.6 118 10.4 5.2 160 5.7 125 9.9 6.0 165 6.3 125 MEAN S.D. N 10.0 .53 6 5.2 .63 6 160 3.4 6 5.7 .45 6 120 4.2 6 Covance 6329-223 3M T-6295.7 660 Appendix 4 Individual Clinical Chemistry Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 10.4 4.9 159 5.4 122 10.5 4.2 165 6.2 124 10.7 5.0 160 5.9 114 11.5 5.8 170 6.6 117 10.6 5.3 163 5.8 118 9.7 5.2 157 5.1 115 MEAN S.D. N 10.6 .58 6 5.1 .53 6 162 4.7 6 5.8 .54 6 118 3.9 6 Covance 6329-223 3M T-6295.7 661 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 57 22 1.0 7.7 4.6 3.1 1.2 8 115 68 58 74 16 1.2 8.9 5.0 3.9 1.2 11 178 82 77 52 25 1.1 7.9 4.7 3.2 .4 12 183 39 84 55 19 1.0 8.2 4.6 3.6 .6 11 124 78 57 60 20 1.2 8.1 5.0 3.1 .4 9 147 42 70 65 20 1.3 8.6 4.9 3.7 .3 10 178 54 67 60 20 1.1 8.2 4.8 3.4 .7 10 154 60 69 8.0 3.0 .12 .45 .19 .34 .41 1.5 29.9 18.3 10.6 6 6 6 6 6 6 6 6 6 6 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 56 18 1.1 8.3 5.0 3.3 .5 63 19 1.3 9.6 5.2 4.4 .3 60 22 1.1 7.9 5.0 2.9 .4 66 17 1.5 9.4 5.5 3.9 .4 7 136 49 52 8 127 97 45 8 117 49 42 6 98 44 43 61 19 1.2 8.8 5.2 3.6 .4 4.3 2.2 .19 .83 .24 .66 .08 4 4 4 4 4 4 4 7 120 1.0 16.3 4 4 60 24.9 4 46 4.5 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 58 21 1.1 8.4 5.3 3.1 .7 11 191 49 74 62 16 .9 8.2 4.7 3.5 .3 7 135 69 60 71 24 1.3 9.3 5.4 3.9 .4 10 145 73 56 74 17 1.1 9.6 4.7 4.9 .2 9 129 74 49 65 27 1.4 8.5 5.0 3.5 .6 11 136 64 53 48 25 1.1 8.6 4.8 3.8 .6 14 157 59 36 63 22 1.2 8.8 5.0 3.8 .5 10 149 65 55 9.4 4.5 .18 .55 .31 .61 .20 2.3 22.8 9.5 12.5 6 6 6 6 6 6 6 6 6 6 6 662 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 80 22 1.6 9.4 5.4 4.0 .2 11 57 51 16 98 23 1.4 9.0 4.8 4.2 .2 14 29 29 9 60 21 1.2 9.0 4.2 4.8 .3 17 65 89 18 55 17 1.0 9.0 4.6 4.4 .3 8 75 41 25 91 19 1.2 8.7 5.1 3.6 .2 24 76 58 27 72 19 1.3 9.2 5.4 3.8 .2 13 87 95 20 76 20 1.3 9.0 4.9 4.1 .2 14 65 60 19 17.0 2.2 .20 .23 .48 .43 .05 5.5 20.3 26.3 6.5 6 6 6 6 6 6 6 6 6 6 6 663 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 29 31 723 156 34 51 490 125 37 29 666 128 23 22 842 79 30 30 1370 238 33 95 659 126 2 157 527 2 130 290 8 194 457 3 135 408 1 184 226 1 191 446 28 377 27 203 12 285 20 307 12 174 39 309 31 4.9 6 43 27.3 6 792 305.3 6 142 53.1 6 3 165 392 2.6 28.5 112.8 6 6 6 23 10.5 6 276 74.9 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 22 13 606 132 35 59 778 109 35 43 1093 163 28 28 258 88 4 92 403 14 273 3 144 713 100 502 1 188 420 19 360 1 108 344 31 220 30 6.3 4 36 19.8 4 684 348.2 4 123 32.2 4 2 133 470 1.5 42.6 165.2 4 4 4 41 40.0 4 339 123.2 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 43 72 740 160 28 43 848 143 33 40 720 129 20 36 897 70 50 75 1241 121 63 63 673 262 4 218 348 30 211 1 178 514 9 392 2 201 356 36 274 1 122 479 28 346 7 213 402 36 282 8 225 475 860 365 40 15.7 6 55 17.2 6 853 207.5 6 148 63.8 6 4 193 429 166 312 3.1 38.4 69.9 339.9 67.7 6 6 6 6 6 664 ANIMAL NUMBER ------ Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 28 24 1262 168 31 39 239 109 52 85 902 88 44 33 415 98 40 46 377 70 37 85 683 141 2 180 758 2 219 499 5 954 504 2 207 494 2 267 439 2 285 406 61 475 9 359 25 371 33 340 25 346 36 296 39 8.8 6 52 26.6 6 646 384.1 6 112 36.1 6 2 352 517 1.2 297.5 124.5 6 6 6 32 17.2 6 364 59.9 6 665 Appendix 4 Individual Clinical Chemistry Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 9.0 6.6 154 4.7 116 11.0 6.2 160 5.4 116 10.3 6.8 150 5.3 110 9.8 6.9 151 5.3 112 9.9 6.9 163 5.8 121 10.8 6.3 164 6.1 119 MEAN S.D. N 10.1 .73 6 6.6 .31 6 157 6.1 6 5.4 .48 6 116 4.1 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 10.2 6.6 154 5.0 113 11.3 6.6 163 6.1 114 10.4 7.2 159 4.9 118 11.2 4.7 161 6.1 122 MEAN S.D. N 10.8 .56 4 6.3 1.09 4 159 3.9 4 5.5 .67 4 117 4.1 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 9.6 5.7 161 5.7 120 10.1 7.2 154 4.8 119 11.3 6.9 159 6.0 114 10.9 6.2 158 5.3 116 9.9 8.6 161 5.6 109 10.3 6.5 154 5.8 112 MEAN S.D. N 10.4 .64 6 6.8 1.01 6 158 3.2 6 5.5 .43 6 115 4.2 6 Covance 6329-223 3M T-6295.7 666 Appendix 4 Individual Clinical Chemistry Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 11.4 7.9 171 6.6 128 10.4 6.7 150 6.4 111 9.5 4.3 153 4.8 107 10.5 5.9 153 5.8 108 11.4 9.1 160 5.1 109 11.3 7.2 163 6.2 114 MEAN S.D. N 10.8 .76 6 6.8 1.66 6 158 7.9 6 5.8 .73 6 113 7.8 6 Covance 6329-223 3M T-6295.7 667 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 48 21 .9 7.6 4.3 3.3 1.0 7 80 53 39 74 22 1.3 9.6 5.6 4.0 .3 9 175 65 73 62 25 1.2 8.2 4.6 3.6 .6 9 177 70 64 57 16 1.2 9.2 4.4 4.8 .4 9 226 175 56 57 23 1.1 9.4 4.6 4.8 .6 9 143 59 42 47 15 1.1 9.3 4.8 4.5 .3 11 175 56 81 58 20 1.1 8.9 4.7 4.2 .5 9.9 4.0 .14 .80 .47 .63 .27 6 6 6 6 6 6 6 9 163 1.3 48.5 6 6 80 47.1 6 59 16.8 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 46 18 1.0 8.6 4.4 4.2 .4 6 102 61 43 70 25 1.3 8.9 4.6 4.3 1.0 9 128 123 61 72 12 .9 8.3 3.8 4.5 .2 10 82 65 41 68 24 1.1 8.5 4.7 3.8 .5 9 127 77 42 64 20 1.1 8.6 4.4 4.2 .5 12.1 6.0 .17 .25 .40 .29 .34 4 4 4 4 4 4 4 8 110 1.7 22.1 4 4 82 28.5 4 47 9.5 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 49 20 1.1 9.2 5.1 4.1 .6 8 133 54 33 53 23 1.0 8.5 4.6 3.9 .3 7 100 57 37 62 18 1.2 8.8 4.2 4.6 .4 9 144 72 56 59 24 1.0 8.3 4.7 3.6 .5 12 136 83 37 58 23 1.1 8.7 4.3 4.4 .4 15 107 86 48 60 27 1.0 9.0 4.1 4.9 .6 8 162 60 34 57 22 1.1 8.8 4.5 4.2 .5 10 130 69 41 4.9 3.1 .08 .33 .37 .48 .12 3.1 23.2 13.7 9.2 6 6 6 6 6 6 6 6 6 6 6 668 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 81 21 1.2 9.6 5.1 4.5 .3 15 100 62 25 74 12 1.4 9.1 4.6 4.5 .3 9 128 69 23 70 13 1.1 9.0 3.9 5.1 .2 8 62 44 20 62 15 1.1 8.7 4.6 4.1 .3 8 80 67 16 87 18 1.1 8.4 4.2 4.2 .4 9 77 84 25 46 26 1.0 8.6 4.6 4.0 .4 43 99 55 28 70 18 1.2 8.9 4.5 4.4 .3 15 91 64 23 14.6 5.3 .14 .43 .41 .40 .08 13.8 23.1 13.5 4.3 6 6 6 6 6 6 6 6 6 6 6 669 ANIMAL NUMBER ------ Group: 1 I05529 I05530 QS I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 52 159 175 78 33 82 305 115 30 51 277 82 31 48 593 171 37 44 266 176 33 79 272 53 3 192 395 1 377 296 2 156 383 2 362 361 1 155 499 2 169 302 11 285 - 175 45 255 8 244 25 342 0 232 36 8.2 6 77 43.3 6 315 143.3 6 112 51.2 6 2 235 373 .8 105.0 74.3 6 6 6 18 17.7 5 256 55.7 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 54 88 221 254 33 70 233 70 17 18 280 42 46 146 312 68 3 395 249 2 293 358 2 79 394 1 253 513 25 182 3 276 11 302 33 341 38 16.2 4 80 52.8 4 262 42.2 4 108 97.8 4 2 255 378 .8 131.7 108.8 4 4 4 18 13.5 4 275 67.7 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 36 47 259 100 31 53 498 78 24 38 169 68 61 131 228 38 26 75 401 67 38 52 292 78 2 268 371 3 118 405 3 201 280 2 330 494 1 126 310 8 412 733 23 212 45 264 34 211 28 322 0 208 19 541 36 13.4 6 66 34.1 6 308 120.9 6 72 20.3 6 3 242 432 2.5 116.5 165.5 6 6 6 25 15.2 6 293 129.4 6 670 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 33 45 285 107 73 42 359 44 34 41 616 47 30 40 230 44 22 62 216 57 46 60 310 66 1 297 374 2 3173 554 7 99 344 2 139 404 1 154 232 1 306 373 33 284 6 406 23 238 36 270 31 178 30 308 40 18.1 6 48 10.0 6 336 146.9 6 61 24.2 6 2 695 2.3 1217.1 6 6 380 104.1 6 26 10.9 6 281 76.1 6 671 Appendix 4 Individual Clinical Chemistry Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 9.4 5.2 144 4.7 107 11.7 6.0 169 6.6 124 10.1 5.8 155 5.8 116 10.7 5.8 163 6.9 125 10.1 5.2 159 5.6 125 9.4 5.8 161 6.5 116 MEAN S.D. N 10.2 .87 6 5.6 .34 6 158 8.5 6 6.0 .81 6 119 7.2 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 8.4 4.0 148 5.1 108 10.9 4.9 163 6.1 118 10.0 3.0 151 5.3 113 10.0 4.6 159 5.8 124 MEAN S.D. N 9.8 1.04 4 4.1 .84 4 155 6.9 4 5.6 .46 4 116 6.8 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 9.5 5.0 153 4.7 110 9.3 3.8 152 5.3 118 9.7 5.7 154 5.8 115 9.9 4.0 152 5.7 114 10.4 5.1 158 4.8 120 10.2 6.3 154 5.9 118 MEAN S.D. N 9.8 .42 6 5.0 .96 6 154 2.2 6 5.4 .52 6 116 3.6 6 Covance 6329-223 3M T-6295.7 672 Appendix 4 Individual Clinical Chemistry Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 10.6 5.0 158 5.3 116 11.7 6.0 166 7.1 114 10.5 5.0 153 7.1 116 10.1 4.0 153 5.9 111 10.6 4.3 161 6.5 124 9.7 5.3 156 5.7 114 MEAN S.D. N 10.5 .67 6 4.9 .71 6 158 5.0 6 6.3 .75 6 116 4.4 6 Covance 6329-223 3M T-6295.7 673 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 64 18 1.1 8.5 4.9 3.6 .9 68 14 1.2 9.1 4.9 4.2 .8 51 25 1.0 7.7 4.6 3.1 .5 59 16 .8 7.7 4.5 3.2 .5 57 21 1.2 8.4 5.1 3.3 .3 64 17 1.2 8.1 4.6 3.5 .4 5 127 45 56 7 166 55 66 5 186 37 82 6 112 35 53 6 165 41 67 6 158 55 54 60 18 1.1 8.2 4.8 3.5 .6 6.1 3.9 .16 .54 .23 .40 .23 6 6 6 6 6 6 6 6 152 .8 27.5 6 6 45 8.7 6 63 11.1 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 62 18 1.2 8.6 4.9 3.7 .3 77 12 1.2 9.1 4.8 4.3 .2 59 27 1.0 8.0 4.8 3.2 .4 57 16 1.4 9.5 5.5 4.0 .3 5 135 28 47 4 104 35 42 5 98 41 38 5 102 27 41 64 18 1.2 8.8 5.0 3.8 .3 9.1 6.3 .16 .65 .34 .47 .08 4 4 4 4 4 4 4 5 110 .5 17.0 4 4 33 6.6 4 42 3.7 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 70 15 1.1 8.6 5.2 3.4 .5 71 13 .8 8.2 4.4 3.8 .2 83 18 1.2 8.5 5.0 3.5 .3 68 16 1.1 9.0 5.2 3.8 .3 72 19 1.3 8.4 4.8 3.6 .4 57 20 1.1 8.2 4.7 3.5 .4 8 190 22 73 5 136 51 53 7 119 31 48 5 137 45 39 5 151 32 42 5 149 35 32 70 17 1.1 8.5 4.9 3.6 .4 8.3 2.6 .17 .30 .31 .17 .10 6 6 6 6 6 6 6 6 147 1.3 24.0 6 6 36 10.4 6 48 14.3 6 674 ANIMAL NUMBER ------ Group: 4 I05506 a I05507 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 107 28 1.8 9.2 4.4 4.8 .2 58 67 75 11 93 22 1.4 9.3 4.8 4.5 .2 28 28 22 8 66 23 .9 8.0 4.2 3.8 .2 18 59 36 20 78 27 1.3 8.8 5.2 3.6 .2 7 38 19 10 67 16 1.4 9.8 5.4 4.4 .3 19 69 44 15 76 22 1.2 9.0 4.9 4.1 .2 18 48 30 13 12.6 4.5 .24 .77 .53 .44 .05 8.6 18.8 11.8 5.4 4 4 4 4 4 4 4 4 4 4 4 a Unscheduled sacrifice on Day 179. 675 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 MEAN S.D. N Group: 2 I05514 I05515 I05516 I05521 MEAN S.D. N Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 28 32 756 169 2 122 524 15 373 35 52 420 126 5 106 308 37 210 41 27 628 149 10 526 440 19 281 23 26 776 72 3 207 388 30 298 30 26 1322 266 7 159 243 22 194 33 69 510 118 11 140 454 51 327 32 6.2 6 39 17.9 6 735 318.7 6 150 65.6 6 6 210 393 3.7 158.7 102.8 6 6 6 29 13.4 6 280 68.5 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 19 16 548 136 34 35 552 100 29 34 1085 182 27 31 233 87 2 93 379 6 219 646 2 143 391 4 96 354 15 260 37 443 15 329 27 224 27 6.2 4 29 8.8 4 604 353.5 4 126 42.6 4 4 138 442 1.9 58.8 136.5 4 4 4 24 10.6 4 314 96.4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 30 39 650 171 4 118 412 36 234 21 20 634 133 3 102 431 7 333 39 51 558 115 7 116 336 36 256 22 58 697 95 3 101 472 36 337 50 69 1035 125 13 296 397 37 277 51 43 557 250 5 314 240 27 184 36 13.3 6 47 16.9 6 688 178.3 6 148 55.8 6 6 174 381 3.8 101.5 82.3 6 6 6 30 11.8 6 270 59.0 6 676 ANIMAL NUMBER ------ Group: 4 I05506 a I05507 I05511 I05512 I05522 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 73 29 876 134 10 4040 738 67 432 30 46 208 110 2 192 474 17 344 41 25 344 101 4 101 524 27 339 36 44 422 71 3 175 379 32 297 30 73 581 132 2 258 408 68 299 34 5.3 4 47 19.7 4 389 155.7 4 104 25.3 4 3 182 446 1.0 64.5 65.3 4 4 4 36 22.2 4 320 25.2 4 a Unscheduled sacrifice on Day 179. 677 Appendix 4 Individual Clinical Chemistry Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 10.1 6.8 156 4.7 111 10.9 5.5 160 5.3 113 10.2 6.5 149 5.2 112 9.7 6.2 151 5.2 109 10.5 7.7 159 5.2 112 9.9 5.6 150 4.9 110 MEAN S.D. N 10.2 .43 6 6.4 .82 6 154 4.8 6 5.1 .23 6 111 1.5 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 9.9 5.7 157 5.1 112 9.9 5.3 155 4.8 107 9.9 7.1 154 4.7 109 10.3 4.9 157 5.4 108 MEAN S.D. N 10.0 .20 4 5.8 .96 4 156 1.5 4 5.0 .32 4 109 2.2 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 10.8 5.0 157 4.8 112 9.7 6.5 152 4.9 113 10.2 6.1 147 5.4 107 10.2 6.3 158 5.2 112 10.1 7.5 158 5.2 110 9.7 5.8 150 4.8 106 MEAN S.D. N 10.1 .41 6 6.2 .82 6 154 4.7 6 5.0 .25 6 110 2.9 6 Covance 6329-223 3M T-6295.7 678 Appendix 4 Individual Clinical Chemistry Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 a 10.6 6.9 157 7.5 111 I05507 10.1 7.2 144 5.5 99 I05511 9.6 4.4 152 5.2 111 I05512 10.3 6.1 157 5.6 109 I05522 11.1 6.7 158 5.4 106 MEAN S.D. N 10.3 .62 4 6.1 1.22 4 153 6.4 4 5.4 .17 4 106 5.3 4 a Unscheduled sacrifice on Day 179. Covance 6329-223 3M T-6295.7 679 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 35 23 .8 8.0 4.4 3.6 .9 58 21 1.3 9.6 5.5 4.1 .3 68 22 1.2 8.4 4.5 3.9 .4 44 16 1.2 9.4 4.7 4.7 .3 75 22 1.2 9.5 4.4 5.1 .4 65 14 1.0 8.7 4.6 4.1 .2 5 87 46 32 6 181 48 71 6 176 74 59 6 226 72 60 7 143 55 43 6 149 44 73 58 20 1.1 8.9 4.7 4.2 .4 15.2 3.7 .18 .66 .42 .55 .25 6 6 6 6 6 6 6 6 160 .6 46.5 6 6 56 13.3 6 56 16.0 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 62 18 1.1 9.1 4.6 4.5 .5 58 18 1.2 9.3 4.7 4.6 .8 53 19 .8 7.6 3.7 3.9 .2 44 25 1.0 8.5 4.6 3.9 .5 4 99 53 33 6 143 66 54 4 109 31 42 7 138 45 37 54 20 1.0 8.6 4.4 4.2 .5 7.8 3.4 .17 .76 .47 .38 .24 4 4 4 4 4 4 4 5 122 1.5 21.6 4 4 49 14.7 4 42 9.1 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 80 17 1.1 9.2 5.0 4.2 .4 10 130 44 25 63 17 .9 8.6 4.6 4.0 .3 7 98 26 34 66 18 1.1 9.0 4.3 4.7 .4 6 154 68 58 56 21 1.0 8.4 4.7 3.7 .5 11 137 56 38 55 16 .9 8.5 4.3 4.2 .3 7 108 37 38 66 24 1.0 9.6 4.0 5.6 .3 7 149 61 25 64 19 1.0 8.9 4.5 4.4 .4 9.0 3.1 .09 .47 .35 .67 .08 6 6 6 6 6 6 6 8 129 2.0 22.3 6 6 49 15.8 6 36 12.1 6 680 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 78 23 1.2 9.1 4.8 4.3 .2 5 88 46 22 74 22 1.4 9.4 4.8 4.6 .2 6 93 77 15 86 12 1.2 9.9 4.0 5.9 .2 5 67 34 21 67 18 1.1 9.1 4.7 4.4 .3 12 76 45 11 80 22 1.1 9.2 4.4 4.8 .2 4 66 67 26 55 25 .9 8.8 4.6 4.2 .4 11 102 50 31 73 20 1.2 9.2 4.6 4.7 .2 11.0 4.7 .16 .37 .31 .63 .08 6 6 6 6 6 6 6 7 82 53 21 3.4 14.7 15.8 7.2 6 6 6 6 681 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 MEAN S.D. N Group: 2 I05537 I05541 I05547 I05550 MEAN S.D. N Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 91 262 169 86 30 55 274 113 25 42 243 81 37 56 554 172 39 61 237 182 26 47 222 48 10 151 350 19 252 2 197 282 16 158 4 84 407 103 274 5 287 351 14 234 7 134 530 41 355 2 422 345 0 275 41 25.0 6 87 85.9 6 283 137.1 6 114 53.3 6 5 212 378 3.1 123.4 84.6 6 6 6 32 37.1 6 258 64.1 6 Dose Level: 0.03 Dosage Unit: mg/kg/day 58 61 207 260 34 60 218 70 26 55 296 50 50 111 236 65 3 2745 254 2 209 337 5 147 347 15 190 496 14 184 12 252 8 265 41 341 42 14.6 4 72 26.3 4 239 39.7 4 111 99.5 4 6 823 6.0 1281.8 4 4 358 100.7 4 19 15.0 4 260 64.4 4 Dose Level: 0.15 Dosage Unit: mg/kg/day 34 38 228 102 29 32 363 69 21 43 118 74 59 126 219 41 42 35 303 65 35 43 295 76 5 167 372 5 95 430 2 238 302 3 321 514 14 109 335 13 164 683 56 204 52 272 42 232 29 323 0 226 17 505 37 13.0 6 53 36.1 6 254 85.3 6 71 19.7 6 7 182 439 5.2 84.7 140.9 6 6 6 33 21.6 6 294 111.7 6 682 ANIMAL NUMBER ------ Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 MEAN S.D. N Appendix 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0.75 Dosage Unit: mg/kg/day 33 43 243 107 33 34 245 43 31 38 659 58 25 37 217 48 32 59 212 63 44 53 320 65 4 253 337 1 203 467 4 189 408 2 296 399 5 515 279 4 251 358 29 256 9 338 19 277 68 252 42 213 20 300 33 6.2 6 44 9.9 6 316 172.4 6 64 22.7 6 3 284 375 1.5 119.3 64.9 6 6 6 31 21.2 6 273 43.1 6 683 Appendix 4 Individual Clinical Chemistry Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 9.1 4.5 142 4.5 102 11.1 6.1 159 6.1 112 9.8 5.2 155 5.1 108 10.6 6.1 159 5.0 112 10.2 5.7 160 5.4 115 10.1 4.1 158 5.7 115 MEAN S.D. N 10.2 .68 6 5.3 .84 6 156 6.8 6 5.3 .56 6 111 5.0 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 9.2 4.2 148 3.9 106 10.9 4.2 163 6.1 114 9.1 5.0 149 4.5 110 9.4 4.3 149 4.5 107 MEAN S.D. N 9.6 .84 4 4.4 .39 4 152 7.2 4 4.8 .94 4 109 3.6 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 9.7 5.4 155 4.8 110 9.6 3.3 149 4.4 108 9.8 5.8 155 5.1 110 9.9 3.7 156 5.1 112 9.6 4.6 151 5.0 113 10.0 5.9 158 5.5 110 MEAN S.D. N 9.8 .16 6 4.8 1.10 6 154 3.3 6 5.0 .37 6 110 1.8 6 Covance 6329-223 3M T-6295.7 684 Appendix 4 Individual Clinical Chemistry Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 9.3 4.7 148 4.3 109 10.8 5.3 160 6.6 113 10.9 5.3 162 5.9 112 9.9 4.4 155 5.0 106 11.0 6.6 158 5.7 107 10.0 5.0 155 4.9 113 MEAN S.D. N 10.3 .69 6 5.2 .76 6 156 4.9 6 5.4 .82 6 110 3.1 6 Covance 6329-223 3M T-6295.7 685 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 59 12 1.1 7.9 4.6 3.3 .6 11 112 43 49 55 19 1.0 8.2 4.7 3.5 .4 13 152 44 67 57 16 1.0 8.0 4.6 3.4 .5 12 132 44 58 2.8 4.9 .07 .21 .07 .14 .14 1.4 28.3 .7 12.7 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 61 17 .8 8.7 5.1 3.6 .8 16 184 37 75 78 17 1.0 9.3 5.1 4.2 .5 16 131 41 47 70 17 .9 9.0 5.1 3.9 .6 16 158 39 61 12.0 .0 .14 .42 .00 .42 .21 .0 37.5 2.8 19.8 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 70 13 1.0 8.7 4.3 4.4 .6 12 140 46 33 76 16 1.1 8.7 4.8 3.9 .6 17 134 92 22 73 14 1.0 8.7 4.6 4.2 .6 14 137 69 28 4.2 2.1 .07 .00 .35 .35 .00 3.5 4.2 32.5 7.8 2 2 2 2 2 2 2 2 2 2 2 686 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 19 23 709 62 24 28 1156 237 3 84 400 4 194 276 30 292 41 209 22 3.5 2 26 3.5 2 932 316.1 2 150 123.7 2 4 139 338 .7 77.8 87.7 2 2 2 36 7.8 2 250 58.7 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 43 45 917 186 11 177 424 48 244 31 42 669 89 13 146 484 45 332 37 8.5 2 44 2.1 2 793 175.4 2 138 68.6 2 12 1.4 2 162 21.9 2 454 42.4 2 46 2.1 2 288 62.2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 36 28 538 127 29 68 499 159 1 177 543 2 223 467 23 362 53 329 32 4.9 2 48 28.3 2 518 27.6 2 143 22.6 2 2 200 505 .7 32.5 53.7 2 2 2 38 21.2 2 346 23.3 2 687 APPENDIX 4 Individual Clinical Chemistry Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 9.6 5.5 150 4.6 112 10.4 7.1 154 5.3 110 MEAN S.D. N 10.0 .57 2 6.3 1.13 2 152 2.8 2 5.0 .49 2 111 1.4 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 11.5 6.6 156 5.5 110 10.4 6.6 154 5.1 106 MEAN S.D. N 11.0 .78 2 6.6 .00 2 155 1.4 2 5.3 .28 2 108 2.8 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 10.6 5.4 157 5.4 112 10.9 7.0 161 5.5 110 MEAN S.D. N 10.8 .21 2 6.2 1.13 2 159 2.8 2 5.4 .07 2 111 1.4 2 Covance 6329-223 3M T-6295.7 688 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 51 19 .7 8.3 4.4 3.9 .7 13 86 108 33 67 12 .9 8.9 4.7 4.2 .1 15 152 37 74 59 16 .8 8.6 4.6 4.0 .4 14 119 72 54 11.3 4.9 .14 .42 .21 .21 .42 1.4 46.7 50.2 29.0 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 76 19 1.0 8.6 4.1 4.5 .6 14 142 59 61 77 16 1.0 8.8 4.0 4.8 .6 13 148 52 26 76 18 1.0 8.7 4.0 4.6 .6 14 145 56 44 .7 2.1 .00 .14 .07 .21 .00 .7 4.2 4.9 24.7 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 82 21 1.1 9.6 5.0 4.6 .6 14 135 62 25 68 25 .8 9.0 4.2 4.8 .5 24 131 93 42 75 23 1.0 9.3 4.6 4.7 .6 19 133 78 34 9.9 2.8 .21 .42 .57 .14 .07 7.1 2.8 21.9 12.0 2 2 2 2 2 2 2 2 2 2 2 689 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 35 120 161 81 34 86 208 41 4 157 377 5 117 309 26 257 0 232 34 .7 2 103 24.0 2 184 33.2 2 61 28.3 2 4 137 343 .7 28.3 48.1 2 2 2 13 18.4 2 244 17.7 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 19 43 113 69 33 54 251 72 1 117 313 7 1197 658 48 235 17 466 26 9.9 2 48 7.8 2 182 97.6 2 70 2.1 2 4 657 486 4.2 763.7 244.0 2 2 2 32 21.9 2 350 163.3 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 23 38 241 121 23 61 200 68 2 144 394 5 186 296 35 289 41 222 23 .0 2 50 16.3 2 220 29.0 2 94 37.5 2 4 165 345 2.1 29.7 69.3 2 2 2 38 4.2 2 256 47.4 2 690 APPENDIX 4 Individual Clinical Chemistry Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 9.7 5.9 145 5.0 103 9.9 3.7 152 5.9 112 MEAN S.D. N 9.8 .14 2 4.8 1.56 2 148 4.9 2 5.4 .64 2 108 6.4 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 9.9 5.7 155 5.5 112 9.7 5.3 150 5.5 109 MEAN S.D. N 9.8 .14 2 5.5 .28 2 152 3.5 2 5.5 .00 2 110 2.1 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 10.4 5.4 152 5.2 111 10.2 6.3 152 4.9 108 MEAN S.D. N 10.3 .14 2 5.8 .64 2 152 .0 2 5.0 .21 2 110 2.1 2 Covance 6329-223 3M T-6295.7 691 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 116 15 1.2 8.8 4.9 3.9 .5 86 17 1.0 8.6 4.8 3.8 .4 8 114 28 73 9 155 38 81 101 16 1.1 8.7 4.8 3.8 .4 21.2 1.4 .14 .14 .07 .07 .07 2 2 2 2 2 2 2 8 134 .7 29.0 2 2 33 7.1 2 77 5.7 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 79 17 1.2 9.1 5.3 3.8 .8 5 193 44 103 83 17 1.0 8.9 5.2 3.7 .4 11 128 52 65 81 17 1.1 9.0 5.2 3.8 .6 2.8 .0 .14 .14 .07 .07 .28 2 2 2 2 2 2 2 8 160 4.2 46.0 2 2 48 5.7 2 84 26.9 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 61 16 1.0 8.6 4.4 4.2 .4 7 132 56 54 84 18 1.0 9.1 4.9 4.2 .4 15 139 71 51 72 17 1.0 8.8 4.6 4.2 .4 11 136 64 52 16.3 1.4 .00 .35 .35 .00 .00 5.7 4.9 10.6 2.1 2 2 2 2 2 2 2 2 2 2 2 692 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 24 27 664 68 30 28 1137 220 2 145 409 6 209 307 33 306 52 234 27 4.2 2 28 .7 2 900 334.5 2 144 107.5 2 4 177 358 2.8 45.3 72.1 2 2 2 42 13.4 2 270 50.9 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 49 40 882 186 19 40 793 98 6 189 422 1 124 503 22 241 52 353 34 21.2 2 40 .0 2 838 62.9 2 142 62.2 2 4 156 462 3.5 46.0 57.3 2 2 2 37 21.2 2 297 79.2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 42 33 736 156 49 73 625 176 1 178 628 6 336 460 17 410 48 333 46 4.9 2 53 28.3 2 680 78.5 2 166 14.1 2 4 257 544 3.5 111.7 118.8 2 2 2 32 21.9 2 372 54.4 2 693 APPENDIX 4 Individual Clinical Chemistry Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 9.9 6.2 152 5.0 117 10.4 7.1 157 5.0 117 MEAN S.D. N 10.2 .35 2 6.6 .64 2 154 3.5 2 5.0 .00 2 117 .0 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 11.3 6.5 160 5.2 118 10.5 6.8 159 5.1 116 MEAN S.D. N 10.9 .57 2 6.6 .21 2 160 .7 2 5.2 .07 2 117 1.4 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 10.4 6.2 159 5.0 118 11.3 7.8 164 5.4 114 MEAN S.D. N 10.8 .64 2 7.0 1.13 2 162 3.5 2 5.2 .28 2 116 2.8 2 Covance 6329-223 3M T-6295.7 694 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 48 20 .7 8.5 4.5 4.0 .8 8 94 61 52 68 15 1.2 9.4 4.7 4.7 .3 10 168 53 88 58 18 1.0 9.0 4.6 4.4 .6 14.1 3.5 .35 .64 .14 .49 .35 2 2 2 2 2 2 2 9 131 1.4 52.3 2 2 57 5.7 2 70 25.5 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 83 19 1.1 8.8 4.0 4.8 .5 12 163 72 91 91 21 .9 9.2 4.2 5.0 .3 10 138 70 52 87 20 1.0 9.0 4.1 4.9 .4 11 150 71 72 5.7 1.4 .14 .28 .14 .14 .14 1.4 17.7 1.4 27.6 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 92 22 1.3 9.8 5.0 4.8 .2 19 151 61 54 91 22 1.2 9.0 4.4 4.6 .3 11 147 129 73 92 22 1.2 9.4 4.7 4.7 .2 15 149 95 64 .7 .0 .07 .57 .42 .14 .07 5.7 2.8 48.1 13.4 2 2 2 2 2 2 2 2 2 2 2 695 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 42 158 160 73 29 74 203 44 2 204 363 3 132 295 21 261 0 222 36 9.2 2 116 59.4 2 182 30.4 2 58 20.5 2 2 168 329 .7 50.9 48.1 2 2 2 10 14.8 2 242 27.6 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 24 61 113 77 37 71 262 83 1 120 311 5 663 654 46 235 21 458 30 9.2 2 66 7.1 2 188 105.4 2 80 4.2 2 3 392 482 2.8 384.0 242.5 2 2 2 34 17.7 2 346 157.7 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 28 41 249 121 22 39 224 74 2 168 385 113 289 1 129 277 19 212 25 4.2 2 40 1.4 2 236 17.7 2 98 33.2 2 2 148 331 .7 27.6 76.4 2 2 2 66 66.5 2 250 54.4 2 696 APPENDIX 4 Individual Clinical Chemistry Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 9.6 4.8 147 4.5 111 9.8 4.4 153 4.8 118 MEAN S.D. N 9.7 .14 2 4.6 .28 2 150 4.2 2 4.6 .21 2 114 4.9 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 9.5 5.6 148 4.9 117 10.2 5.2 155 5.9 120 MEAN S.D. N 9.8 .49 2 5.4 .28 2 152 4.9 2 5.4 .71 2 118 2.1 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 10.2 4.9 155 4.8 116 11.0 5.9 166 6.2 125 MEAN S.D. N 10.6 .57 2 5.4 .71 2 160 7.8 2 5.5 .99 2 120 6.4 2 Covance 6329-223 3M T-6295.7 697 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 80 13 1.3 8.8 4.8 4.0 .7 54 18 1.1 8.2 4.6 3.6 .1 3 112 25 54 2 149 47 75 67 16 1.2 8.5 4.7 3.8 .4 18.4 3.5 .14 .42 .14 .28 .42 2 2 2 2 2 2 2 2 130 .7 26.2 2 2 36 15.6 2 64 14.8 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 76 18 .9 9.0 5.2 3.8 .5 11 203 38 94 72 20 1.1 8.7 4.9 3.8 .3 7 132 57 57 74 19 1.0 8.8 5.0 3.8 .4 2.8 1.4 .14 .21 .21 .00 .14 2 2 2 2 2 2 2 9 168 2.8 50.2 2 2 48 13.4 2 76 26.2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 63 20 1.0 8.8 4.5 4.3 .4 5 135 58 45 76 15 1.3 8.9 5.1 3.8 .2 10 143 91 35 70 18 1.2 8.8 4.8 4.0 .3 9.2 3.5 .21 .07 .42 .35 .14 2 2 2 2 2 2 2 8 139 3.5 5.7 2 2 74 23.3 2 40 7.1 2 698 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 19 31 552 60 4 151 368 31 277 37 39 1131 188 10 201 267 41 201 28 12.7 2 35 5.7 2 842 409.4 2 124 90.5 2 7 176 318 4.2 35.4 71.4 2 2 2 36 7.1 2 239 53.7 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 31 42 925 195 22 36 776 96 2 157 414 6 125 475 41 232 37 338 26 6.4 2 39 4.2 2 850 105.4 2 146 70.0 2 4 141 444 2.8 22.6 43.1 2 2 2 39 2.8 2 285 75.0 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 41 39 821 158 36 69 557 169 3 167 572 4 294 453 18 377 52 331 38 3.5 2 54 21.2 2 689 186.7 2 164 7.8 2 4 230 512 .7 89.8 84.1 2 2 2 35 24.0 2 354 32.5 2 699 APPENDIX 4 Individual Clinical Chemistry Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 10.3 5.2 157 5.9 116 10.0 6.8 150 5.6 115 MEAN S.D. N 10.2 .21 2 6.0 1.13 2 154 4.9 2 5.8 .21 2 116 .7 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 12.0 6.2 164 5.9 123 10.3 6.5 154 5.4 114 MEAN S.D. N 11.2 1.20 2 6.4 .21 2 159 7.1 2 5.6 .35 2 118 6.4 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 10.8 5.7 158 5.4 115 11.6 7.0 163 5.9 112 MEAN S.D. N 11.2 .57 2 6.4 .92 2 160 3.5 2 5.6 .35 2 114 2.1 2 Covance 6329-223 3M T-6295.7 700 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 45 23 .8 8.1 4.2 3.9 1.0 7 88 42 43 67 16 .8 9.3 4.6 4.7 .2 10 170 53 80 56 20 .8 8.7 4.4 4.3 .6 15.6 4.9 .00 .85 .28 .57 .57 2 2 2 2 2 2 2 8 129 2.1 58.0 2 2 48 7.8 2 62 26.2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 78 19 .8 8.7 4.0 4.7 .5 71 23 1.0 9.1 4.0 5.1 .2 5 148 67 68 5 139 51 36 74 21 .9 8.9 4.0 4.9 .4 4.9 2.8 .14 .28 .00 .28 .21 2 2 2 2 2 2 2 5 144 .0 6.4 2 2 59 11.3 2 52 22.6 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 95 20 .9 9.2 4.7 4.5 .1 90 26 1.1 8.7 4.1 4.6 .1 4 145 47 53 7 144 92 59 92 23 1.0 9.0 4.4 4.6 .1 3.5 4.2 .14 .35 .42 .07 .00 2 2 2 2 2 2 2 6 144 2.1 .7 2 2 70 31.8 2 56 4.2 2 701 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 47 128 138 70 33 79 188 45 2 167 328 4 435 290 18 232 0 218 40 9.9 2 104 34.6 2 163 35.4 2 58 17.7 2 3 301 309 1.4 189.5 26.9 2 2 2 9 12.7 2 225 9.9 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 27 60 105 77 4 113 287 50 214 47 57 238 76 14 2316 649 98 465 37 14.1 2 58 2.1 2 172 94.0 2 76 .7 2 9 1214 7.1 1557.8 2 2 468 256.0 2 74 33.9 2 340 177.5 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 42 51 244 108 16 36 208 66 6 165 396 4 120 235 34 295 31 177 29 18.4 2 44 10.6 2 226 25.5 2 87 29.7 2 5 142 316 1.4 31.8 113.8 2 2 2 32 2.1 2 236 83.4 2 702 APPENDIX 4 Individual Clinical Chemistry Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 9.3 4.6 144 4.3 107 10.4 4.2 155 5.6 114 MEAN S.D. N 9.8 .78 2 4.4 .28 2 150 7.8 2 5.0 .92 2 110 4.9 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 9.5 5.3 152 5.4 115 9.5 5.2 148 4.1 107 MEAN S.D. N 9.5 .00 2 5.2 .07 2 150 2.8 2 4.8 .92 2 111 5.7 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 10.4 5.8 154 6.1 121 10.4 4.6 157 6.0 117 MEAN S.D. N 10.4 .00 2 5.2 .85 2 156 2.1 2 6.0 .07 2 119 2.8 2 Covance 6329-223 3M T-6295.7 703 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 74 19 1.3 8.5 4.7 3.8 .8 68 16 1.2 8.6 4.9 3.7 .0 5 109 67 57 6 158 36 81 71 18 1.2 8.6 4.8 3.8 .4 4.2 2.1 .07 .07 .14 .07 .57 2 2 2 2 2 2 2 6 134 .7 34.6 2 2 52 21.9 2 69 17.0 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 45 26 1.3 9.0 5.2 3.8 1.2 78 30 1.6 8.4 5.0 3.4 .2 8 209 48 91 6 117 74 54 62 28 1.4 8.7 5.1 3.6 .7 23.3 2.8 .21 .42 .14 .28 .71 2 2 2 2 2 2 2 7 163 1.4 65.1 2 2 61 18.4 2 72 26.2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 55 18 1.2 8.2 4.4 3.8 .6 76 19 1.7 8.9 5.0 3.9 .2 6 137 54 44 9 136 127 34 66 18 1.4 8.6 4.7 3.8 .4 14.8 .7 .35 .49 .42 .07 .28 2 2 2 2 2 2 2 8 136 2.1 .7 2 2 90 51.6 2 39 7.1 2 704 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 34 34 499 50 42 43 1046 199 3 860 512 5 1071 462 90 380 98 352 38 5.7 2 38 6.4 2 772 386.8 2 124 105.4 2 4 966 487 1.4 149.2 35.4 2 2 2 94 5.7 2 366 19.8 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 60 63 995 189 46 73 770 92 6 515 1618 871 1193 6 624 976 549 731 53 9.9 2 68 7.1 2 882 159.1 2 140 68.6 2 6 570 1297 710 962 .0 77.1 454.0 227.7 326.7 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 76 59 844 156 46 92 573 158 3 787 727 1 1308 523 36 503 25 382 61 21.2 2 76 23.3 2 708 191.6 2 157 1.4 2 2 1048 1.4 368.4 2 2 625 144.2 2 30 7.8 2 442 85.6 2 705 APPENDIX 4 Individual Clinical Chemistry Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 10.1 5.0 148 4.9 107 10.8 5.8 153 5.1 106 MEAN S.D. N 10.4 .49 2 5.4 .57 2 150 3.5 2 5.0 .14 2 106 .7 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 11.6 6.3 154 5.1 104 10.3 5.4 154 5.0 108 MEAN S.D. N 11.0 .92 2 5.8 .64 2 154 .0 2 5.0 .07 2 106 2.8 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 9.9 5.0 151 5.1 108 11.2 6.6 158 5.6 108 MEAN S.D. N 10.6 .92 2 5.8 1.13 2 154 4.9 2 5.4 .35 2 108 .0 2 Covance 6329-223 3M T-6295.7 706 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- SBA UMOL/L -------- CHOL MG/DL -------- TRIG MG/DL -------- HDL MG/DL -------- Dose Level: 0 Dosage Unit: mg/kg/day 44 16 1.4 8.4 4.4 4.0 .9 6 89 48 41 64 14 1.1 8.5 4.3 4.2 .1 13 148 36 74 54 15 1.2 8.4 4.4 4.1 .5 10 118 42 58 14.1 1.4 .21 .07 .07 .14 .57 4.9 41.7 8.5 23.3 2 2 2 2 2 2 2 2 2 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 69 27 1.4 8.2 3.8 4.4 .5 11 141 102 74 58 28 1.2 9.3 4.0 5.3 .5 6 154 69 46 64 28 1.3 8.8 3.9 4.8 .5 7.8 .7 .14 .78 .14 .64 .00 2 2 2 2 2 2 2 8 148 3.5 9.2 2 2 86 23.3 2 60 19.8 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 86 25 1.6 9.1 4.6 4.5 .1 84 12 1.4 8.2 4.0 4.2 .0 8 139 68 60 5 119 81 60 85 18 1.5 8.7 4.3 4.4 .0 1.4 9.2 .14 .64 .42 .21 .07 2 2 2 2 2 2 2 6 129 2.1 14.1 2 2 74 9.2 2 60 .0 2 707 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- ALK PHOS IU/L -------- GGT IU/L -------- SDH IU/L -------- CK IU/L -------- AMYLASE IU/L -------- LIPASE IU/L -------- P AMYL U/L -------- Dose Level: 0 Dosage Unit: mg/kg/day 66 97 143 82 46 77 169 39 2 1212 390 5 1024 342 0 277 0 260 56 14.1 2 87 14.1 2 156 18.4 2 60 30.4 2 4 1118 2.1 132.9 2 2 366 33.9 2 0 268 .0 12.0 2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 36 71 114 67 60 85 205 79 4 602 386 9 1513 722 63 288 83 524 48 17.0 2 78 9.9 2 160 64.3 2 73 8.5 2 6 1058 3.5 644.2 2 2 554 237.6 2 73 14.1 2 406 166.9 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 43 70 250 105 46 155 220 55 2 1471 448 1 659 450 33 337 94 339 44 2.1 2 112 60.1 2 235 21.2 2 80 35.4 2 2 1065 .7 574.2 2 2 449 1.4 2 64 43.1 2 338 1.4 2 708 APPENDIX 4 Individual Clinical Chemistry Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 9.8 5.0 146 5.1 100 9.6 4.4 148 4.8 107 MEAN S.D. N 9.7 .14 2 4.7 .42 2 147 1.4 2 5.0 .21 2 104 4.9 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 9.4 4.8 148 5.2 107 10.2 5.5 154 5.1 109 MEAN S.D. N 9.8 .57 2 5.2 .49 2 151 4.2 2 5.2 .07 2 108 1.4 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 10.3 4.4 154 5.2 109 10.3 4.1 158 5.8 111 MEAN S.D. N 10.3 .00 2 4.2 .21 2 156 2.8 2 5.5 .42 2 110 1.4 2 Covance 6329-223 3M T-6295.7 709 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU UN CREAT T PRO ALB GLOB T BILI SBA CHOL TRIG HDL MG/DL MG/DL MG/DL G/DL G/DL G/DL MG/DL UMOL/L MG/DL MG/DL MG/DL -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 74 17 1.3 8.9 5.0 3.9 .7 71 24 1.3 8.9 5.3 3.6 .3 5 105 35 51 6 148 46 71 72 20 1.3 8.9 5.2 3.8 .5 2.1 4.9 .00 .00 .21 .21 .28 2 2 2 2 2 2 2 6 126 .7 30.4 2 2 40 7.8 2 61 14.1 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 73 23 1.2 9.0 5.4 3.6 1.1 76 28 1.1 8.1 4.9 3.2 .5 7 206 33 93 6 127 64 54 74 26 1.2 8.6 5.2 3.4 .8 2.1 3.5 .07 .64 .35 .28 .42 2 2 2 2 2 2 2 6 166 .7 55.9 2 2 48 21.9 2 74 27.6 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 63 19 1.1 8.3 4.5 3.8 .6 76 17 1.3 8.5 5.0 3.5 .3 6 116 36 41 3 122 66 34 70 18 1.2 8.4 4.8 3.6 .4 9.2 1.4 .14 .14 .35 .21 .21 2 2 2 2 2 2 2 4 119 2.1 4.2 2 2 51 21.2 2 38 4.9 2 710 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT ALT/SGPT ALK PHOS GGT SDH CK AMYLASE LIPASE P AMYL IU/L IU/L IU/L IU/L IU/L IU/L IU/L IU/L U/L -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 46 45 387 53 53 38 1040 222 3 2123 388 8 2151 363 38 298 37 246 50 4.9 2 42 4.9 2 714 461.7 2 138 119.5 2 6 2137 3.5 19.8 2 2 376 17.7 2 38 .7 2 272 36.8 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 64 63 915 188 55 70 725 98 9 1243 1640 8 1747 948 793 1207 365 710 60 6.4 2 66 4.9 2 820 134.4 2 143 63.6 2 8 1495 1294 .7 356.4 489.3 2 2 2 579 302.6 2 958 351.4 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 62 48 765 154 58 84 479 156 6 617 616 2 2004 415 35 414 31 302 60 2.8 2 66 25.5 2 622 202.2 2 155 1.4 2 4 1310 2.8 980.8 2 2 516 142.1 2 33 2.8 2 358 79.2 2 711 APPENDIX 4 Individual Clinical Chemistry Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA I PHOS NA K CL MG/DL MG/DL MMOL/L MMOL/L MMOL/L -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 10.3 4.2 154 5.3 111 11.0 5.2 157 5.5 111 MEAN S.D. N 10.6 .49 2 4.7 .71 2 156 2.1 2 5.4 .14 2 111 .0 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 11.9 5.7 160 5.8 113 9.9 5.5 150 5.1 109 MEAN S.D. N 10.9 1.41 2 5.6 .14 2 155 7.1 2 5.4 .49 2 111 2.8 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 10.2 5.2 153 5.9 113 10.9 4.6 156 5.0 108 MEAN S.D. N 10.6 .49 2 4.9 .42 2 154 2.1 2 5.4 .64 2 110 3.5 2 Covance 6329-223 3M T-6295.7 712 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU UN CREAT T PRO ALB GLOB T BILI SBA CHOL TRIG HDL MG/DL MG/DL MG/DL G/DL G/DL G/DL MG/DL UMOL/L MG/DL MG/DL MG/DL -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 54 21 .9 8.9 4.7 4.2 1.1 56 18 1.1 9.0 4.7 4.3 .4 5 112 56 40 6 162 42 79 55 20 1.0 9.0 4.7 4.2 .8 1.4 2.1 .14 .07 .00 .07 .49 2 2 2 2 2 2 2 6 137 .7 35.4 2 2 49 9.9 2 60 27.6 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 66 22 1.1 8.3 3.8 4.5 .8 80 26 1.0 9.1 4.0 5.1 .7 6 136 66 71 6 138 43 36 73 24 1.0 8.7 3.9 4.8 .8 9.9 2.8 .07 .57 .14 .42 .07 2 2 2 2 2 2 2 6 137 .0 1.4 2 2 54 16.3 2 54 24.7 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 91 21 1.2 9.2 4.9 4.3 .3 13 152 55 55 85 25 1.1 8.1 4.0 4.1 .4 5 131 95 66 88 23 1.2 8.7 4.4 4.2 .4 4.2 2.8 .07 .78 .64 .14 .07 2 2 2 2 2 2 2 9 142 5.7 14.8 2 2 75 28.3 2 60 7.8 2 713 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT ALT/SGPT ALK PHOS GGT SDH CK AMYLASE LIPASE P AMYL IU/L IU/L IU/L IU/L IU/L IU/L IU/L IU/L U/L -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 110 297 157 109 61 106 167 45 7 2978 459 5 1838 338 33 336 0 265 86 34.6 2 202 135.1 2 162 7.1 2 77 45.3 2 6 2408 1.4 806.1 2 2 398 85.6 2 16 23.3 2 300 50.2 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 37 61 109 78 8 733 304 42 231 62 95 188 80 15 1009 630 52 459 50 17.7 2 78 24.0 2 148 55.9 2 79 1.4 2 12 4.9 2 871 195.2 2 467 230.5 2 47 7.1 2 345 161.2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 67 78 243 117 45 83 213 56 5 2353 527 3 1241 431 47 412 47 329 56 15.6 2 80 3.5 2 228 21.2 2 86 43.1 2 4 1797 1.4 786.3 2 2 479 67.9 2 47 .0 2 370 58.7 2 714 APPENDIX 4 Individual Clinical Chemistry Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA I PHOS NA K CL MG/DL MG/DL MMOL/L MMOL/L MMOL/L -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 9.7 5.6 144 4.3 103 10.1 4.2 151 5.6 109 MEAN S.D. N 9.9 .28 2 4.9 .99 2 148 4.9 2 5.0 .92 2 106 4.2 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 9.0 4.8 146 4.9 108 9.9 4.7 151 5.9 111 MEAN S.D. N 9.4 .64 2 4.8 .07 2 148 3.5 2 5.4 .71 2 110 2.1 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 10.5 4.6 153 5.3 111 10.0 4.3 157 5.6 113 MEAN S.D. N 10.2 .35 2 4.4 .21 2 155 2.8 2 5.4 .21 2 112 1.4 2 Covance 6329-223 3M T-6295.7 715 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU UN CREAT T PRO ALB GLOB T BILI SBA CHOL TRIG HDL MG/DL MG/DL MG/DL G/DL G/DL G/DL MG/DL UMOL/L MG/DL MG/DL MG/DL -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 80 12 1.2 8.9 5.2 3.7 .8 68 16 1.2 8.5 4.9 3.6 .3 3 122 31 56 3 142 32 61 74 14 1.2 8.7 5.0 3.6 .6 8.5 2.8 .00 .28 .21 .07 .35 2 2 2 2 2 2 2 3 132 .0 14.1 2 2 32 .7 2 58 3.5 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 88 15 1.2 9.3 5.4 3.9 .6 94 17 1.1 8.9 5.5 3.4 .3 5 216 6 139 39 106 43 55 91 16 1.2 9.1 5.4 3.6 .4 4.2 1.4 .07 .28 .07 .35 .21 2 2 2 2 2 2 2 6 178 .7 54.4 2 2 41 2.8 2 80 36.1 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 64 13 1.0 8.5 4.5 4.0 .8 75 14 1.3 9.3 5.4 3.9 .3 4 122 37 44 3 114 81 26 70 14 1.2 8.9 5.0 4.0 .6 7.8 .7 .21 .57 .64 .07 .35 2 2 2 2 2 2 2 4 118 .7 5.7 2 2 59 31.1 2 35 12.7 2 716 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT ALT/SGPT ALK PHOS GGT SDH CK AMYLASE LIPASE P AMYL IU/L IU/L IU/L IU/L IU/L IU/L IU/L IU/L U/L -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 19 21 394 59 2 77 319 11 246 29 26 847 189 10 126 276 21 220 24 7.1 2 24 3.5 2 620 320.3 2 124 91.9 2 6 102 298 5.7 34.6 30.4 2 2 2 16 7.1 2 233 18.4 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 29 46 971 198 21 45 771 101 2 163 413 1 119 487 14 235 17 353 25 5.7 2 46 .7 2 871 141.4 2 150 68.6 2 2 141 450 .7 31.1 52.3 2 2 2 16 2.1 2 294 83.4 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 37 32 458 129 30 50 379 148 1 179 480 0 225 364 20 326 13 263 34 4.9 2 41 12.7 2 418 55.9 2 138 13.4 2 0 202 422 .7 32.5 82.0 2 2 2 16 4.9 2 294 44.5 2 717 APPENDIX 4 Individual Clinical Chemistry Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA I PHOS NA K CL MG/DL MG/DL MMOL/L MMOL/L MMOL/L -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 10.4 5.7 156 5.7 113 10.1 6.4 150 5.1 109 MEAN S.D. N 10.2 .21 2 6.0 .49 2 153 4.2 2 5.4 .42 2 111 2.8 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 12.6 6.6 167 6.3 118 10.9 7.2 161 5.6 113 MEAN S.D. N 11.8 1.20 2 6.9 .42 2 164 4.2 2 6.0 .49 2 116 3.5 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 10.0 3.9 152 4.6 113 11.1 6.7 158 5.4 109 MEAN S.D. N 10.6 .78 2 5.3 1.98 2 155 4.2 2 5.0 .57 2 111 2.8 2 Covance 6329-223 3M T-6295.7 718 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU UN CREAT T PRO ALB GLOB T BILI SBA CHOL TRIG HDL MG/DL MG/DL MG/DL G/DL G/DL G/DL MG/DL UMOL/L MG/DL MG/DL MG/DL -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 48 17 .9 8.3 4.6 3.7 1.0 79 17 1.0 8.7 4.6 4.1 .3 7 99 60 34 4 142 52 67 64 17 1.0 8.5 4.6 3.9 .6 21.9 .0 .07 .28 .00 .28 .49 2 2 2 2 2 2 2 6 120 2.1 30.4 2 2 56 5.7 2 50 23.3 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 79 16 1.0 8.4 4.1 4.3 .6 78 18 .9 9.0 4.1 4.9 .5 4 144 83 58 6 144 59 36 78 17 1.0 8.7 4.1 4.6 .6 .7 1.4 .07 .42 .00 .42 .07 2 2 2 2 2 2 2 5 144 1.4 .0 2 2 71 17.0 2 47 15.6 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 98 17 1.1 9.1 4.9 4.2 .2 101 21 1.0 8.2 4.1 4.1 .3 5 137 42 55 3 139 114 72 100 19 1.0 8.7 4.5 4.2 .2 2.1 2.8 .07 .64 .57 .07 .07 2 2 2 2 2 2 2 4 138 1.4 1.4 2 2 78 50.9 2 64 12.0 2 719 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT ALT/SGPT ALK PHOS GGT SDH CK AMYLASE LIPASE P AMYL IU/L IU/L IU/L IU/L IU/L IU/L IU/L IU/L U/L -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 56 183 139 96 30 85 174 49 6 200 293 3 244 244 9 216 12 192 43 18.4 2 134 69.3 2 156 24.7 2 72 33.2 2 4 222 268 2.1 31.1 34.6 2 2 2 10 2.1 2 204 17.0 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 25 34 94 76 4 112 242 15 189 40 66 186 81 10 254 436 11 312 32 10.6 2 50 22.6 2 140 65.1 2 78 3.5 2 7 183 339 4.2 100.4 137.2 2 2 2 13 2.8 2 250 87.0 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 25 64 248 124 25 43 216 63 0 134 360 3 114 233 13 277 23 183 25 .0 2 54 14.8 2 232 22.6 2 94 43.1 2 2 124 296 2.1 14.1 89.8 2 2 2 18 7.1 2 230 66.5 2 720 APPENDIX 4 Individual Clinical Chemistry Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA I PHOS NA K CL MG/DL MG/DL MMOL/L MMOL/L MMOL/L -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 9.6 4.9 144 4.9 105 10.2 5.4 152 5.1 110 MEAN S.D. N 9.9 .42 2 5.2 .35 2 148 5.7 2 5.0 .14 2 108 3.5 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 9.5 5.3 151 5.4 111 10.1 5.0 153 5.9 112 MEAN S.D. N 9.8 .42 2 5.2 .21 2 152 1.4 2 5.6 .35 2 112 .7 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 10.3 5.1 155 5.6 114 10.5 5.6 154 6.8 118 MEAN S.D. N 10.4 .14 2 5.4 .35 2 154 .7 2 6.2 .85 2 116 2.8 2 Covance 6329-223 3M T-6295.7 721 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU UN CREAT T PRO ALB GLOB T BILI SBA CHOL TRIG HDL MG/DL MG/DL MG/DL G/DL G/DL G/DL MG/DL UMOL/L MG/DL MG/DL MG/DL -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 79 14 1.2 8.7 4.6 4.1 .5 86 18 1.3 8.9 4.8 4.1 .2 6 119 30 63 5 150 32 77 82 16 1.2 8.8 4.7 4.1 .4 4.9 2.8 .07 .14 .14 .00 .21 2 2 2 2 2 2 2 6 134 .7 21.9 2 2 31 1.4 2 70 9.9 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 77 19 1.2 8.6 4.9 3.7 .6 81 19 1.1 9.0 5.3 3.7 .3 5 200 3 132 31 114 40 69 79 19 1.2 8.8 5.1 3.7 .4 2.8 .0 .07 .28 .28 .00 .21 2 2 2 2 2 2 2 4 166 1.4 48.1 2 2 36 6.4 2 92 31.8 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 75 16 1.4 9.5 5.0 4.5 .8 4 145 37 67 83 16 1.4 9.3 5.2 4.1 .3 10 132 52 47 79 16 1.4 9.4 5.1 4.3 .6 5.7 .0 .00 .14 .14 .28 .35 2 2 2 2 2 2 2 7 138 4.2 9.2 2 2 44 10.6 2 57 14.1 2 722 ANIMAL NUMBER ------ Group: 1 I05520 I05526 MEAN S.D. N Group: 3 I05505 I05523 MEAN S.D. N Group: 4 I05511 I05522 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT ALT/SGPT ALK PHOS GGT SDH CK AMYLASE LIPASE P AMYL IU/L IU/L IU/L IU/L IU/L IU/L IU/L IU/L U/L -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 19 20 309 49 1 78 265 10 203 28 30 701 183 19 144 259 17 201 24 6.4 2 25 7.1 2 505 277.2 2 116 94.8 2 10 12.7 2 111 46.7 2 262 4.2 2 14 4.9 2 202 1.4 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 31 36 846 178 30 33 662 93 1 130 357 5 212 446 12 206 13 321 30 .7 2 34 2.1 2 754 130.1 2 136 60.1 2 3 171 402 2.8 58.0 62.9 2 2 2 12 .7 2 264 81.3 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 45 37 467 149 27 42 342 147 0 165 519 0 165 362 22 334 11 260 36 12.7 2 40 3.5 2 404 88.4 2 148 1.4 2 0 165 440 .0 .0 111.0 2 2 2 16 7.8 2 297 52.3 2 723 APPENDIX 4 Individual Clinical Chemistry Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA I PHOS NA K CL MG/DL MG/DL MMOL/L MMOL/L MMOL/L -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 10.8 6.5 162 6.4 120 10.5 6.6 157 5.6 111 MEAN S.D. N 10.6 .21 2 6.6 .07 2 160 3.5 2 6.0 .57 2 116 6.4 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 11.4 6.3 164 5.8 117 11.0 7.6 169 6.9 122 MEAN S.D. N 11.2 .28 2 7.0 .92 2 166 3.5 2 6.4 .78 2 120 3.5 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 12.0 5.4 174 6.0 121 11.8 6.2 169 6.2 116 MEAN S.D. N 11.9 .14 2 5.8 .57 2 172 3.5 2 6.1 .14 2 118 3.5 2 Covance 6329-223 3M T-6295.7 724 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS GLU UN CREAT T PRO ALB GLOB T BILI SBA CHOL TRIG HDL MG/DL MG/DL MG/DL G/DL G/DL G/DL MG/DL UMOL/L MG/DL MG/DL MG/DL -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 67 17 .9 8.2 4.4 3.8 .8 53 16 1.0 8.8 4.4 4.4 .3 6 96 55 44 5 152 51 83 60 16 1.0 8.5 4.4 4.1 .6 9.9 .7 .07 .42 .00 .42 .35 2 2 2 2 2 2 2 6 124 .7 39.6 2 2 53 2.8 2 64 27.6 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 71 19 1.1 8.5 3.9 4.6 .5 74 17 .8 8.2 3.6 4.6 .6 5 147 73 86 5 129 46 37 72 18 1.0 8.4 3.8 4.6 .6 2.1 1.4 .21 .21 .21 .00 .07 2 2 2 2 2 2 2 5 138 .0 12.7 2 2 60 19.1 2 62 34.6 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 100 19 1.2 9.0 4.6 4.4 .3 93 19 1.2 7.9 4.0 3.9 .3 6 145 40 68 4 147 112 79 96 19 1.2 8.4 4.3 4.2 .3 4.9 .0 .00 .78 .42 .35 .00 2 2 2 2 2 2 2 5 146 1.4 1.4 2 2 76 50.9 2 74 7.8 2 725 ANIMAL NUMBER ------ Group: 1 I05529 I05549 MEAN S.D. N Group: 3 I05539 I05552 MEAN S.D. N Group: 4 I05533 I05542 MEAN S.D. N APPENDIX 4 Covance 6329-223 3M T-6295.7 Individual Clinical Chemistry Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS AST/SGOT ALT/SGPT ALK PHOS GGT SDH CK AMYLASE LIPASE P AMYL IU/L IU/L IU/L IU/L IU/L IU/L IU/L IU/L U/L -------- -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 53 191 131 93 30 49 171 45 0 216 316 0 93 245 11 232 12 192 42 16.3 2 120 100.4 2 151 28.3 2 69 33.9 2 0 154 280 .0 87.0 50.2 2 2 2 12 .7 2 212 28.3 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 27 31 96 76 26 37 195 82 2 80 252 1 109 454 14 195 8 327 26 .7 2 34 4.2 2 146 70.0 2 79 4.2 2 2 94 353 11 261 .7 20.5 142.8 4.2 93.3 2 2 2 2 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 36 79 240 117 19 39 186 61 3 164 372 0 97 250 12 286 18 195 28 12.0 2 59 28.3 2 213 38.2 2 89 39.6 2 2 130 311 2.1 47.4 86.3 2 2 2 15 4.2 2 240 64.3 2 726 APPENDIX 4 Individual Clinical Chemistry Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ CA I PHOS NA K CL MG/DL MG/DL MMOL/L MMOL/L MMOL/L -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 10.1 5.2 150 5.1 108 10.1 5.6 152 5.3 111 MEAN S.D. N 10.1 .00 2 5.4 .28 2 151 1.4 2 5.2 .14 2 110 2.1 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 9.8 5.4 155 5.4 112 10.2 4.9 157 6.1 117 MEAN S.D. N 10.0 .28 2 5.2 .35 2 156 1.4 2 5.8 .49 2 114 3.5 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 10.3 5.9 159 5.6 115 10.7 5.4 165 6.7 124 MEAN S.D. N 10.5 .28 2 5.6 .35 2 162 4.2 2 6.2 .78 2 120 6.4 2 Covance 6329-223 3M T-6295.7 727 Appendix 4 Individual Clinical Urinalysis Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 37.0 1.025 8.0 28.0 1.032 7.0 47.0 1.025 8.0 75.0 1.018 7.5 32.0 1.030 7.5 30.0 1.023 6.0 MEAN S.D. N 41.5 17.76 6 1.026 .0050 6 7.3 .75 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 67.0 1.019 7.0 46.0 1.023 7.5 52.0 1.020 7.0 45.0 1.023 8.0 MEAN S.D. N 52.5 10.15 4 1.021 .0021 4 7.4 .48 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 228.0 1.007 7.0 52.0 1.025 7.0 93.0 1.020 7.0 43.0 1.026 7.0 46.0 1.025 7.5 125.0 1.013 7.0 MEAN S.D. N 97.8 71.41 6 1.019 .0078 6 7.1 .20 6 Covance 6329-223 3M T-6295.7 728 Appendix 4 Individual Clinical Urinalysis Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 43.0 1.026 7.0 59.0 1.022 7.5 68.0 1.018 7.0 173.0 1.008 7.0 92.0 1.013 7.5 66.0 1.022 7.0 MEAN S.D. N 83.5 46.63 6 1.018 .0066 6 7.2 .26 6 Covance 6329-223 3M T-6295.7 729 Appendix 4 Individual Clinical Urinalysis Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 0 - I05517 10 - I05519 0 - I05520 0 + I05526 10 + I05527 0 - +++ - +++ - - - +++ - + - ++ - +++ - - - - - - - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 0 - - - - - I05515 0 - - - - - I05516 10 - ++ - + - I05521 10 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - I05510 10 - I05518 30 + I05523 10 - I05524 10 - I05528 0 - - - - - - - - - ++ - - - - - - - +++ - - - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 10 - I05507 0 - I05509 10 - I05511 0 - I05512 0 - I05522 10 - ++ - - - - - - - + - - - + - ++ - - - - - + - - - Covance 6329-223 3M T-6295.7 730 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 Group: 2 I05514 I05515 I05516 I05521 Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 Appendix 4 Individual Clinical Urinalysis Data Males Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 0 3 0 2B4D 0 DK 0 0 2 3 0 2B4D 0 DK 0 0 0 3 0 4B4E 0 CL 0 0 1 2 0 4B4D 0 BK 0 0 1 2 0 4B3D 0 CK 0 0 0 1 0 4B3E 0 BK Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 1 3 0 4B2E 0 CK 0 0 0 3 0 4B4D 4E CL 0 0 0 3 0 4B2D 0 CK 0 0 0 3 0 4B4D 0 BL Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 1 2 0 3B 0 BK 0 0 0 3 0 4B4D 4E BL 0 0 4 3 0 4B 0 DL 0 0 0 3 0 4B2D 0 BL 0 0 0 3 0 3B4D 0 CK 0 0 1 3 0 4B 0 BK Dose Level: 0.75 Dosage Unit: mg/kg/day 2 0 1 3 0 2B2D 0 CK 0 1 0 3 0 4B4D 0 CL 0 1 4 3 0 4B1E 0 BK 0 0 1 3 0 4B 0 BK 0 0 1 3 0 2B 0 BK 0 1 1 2 0 2B 0 BJ COMMENTS -------- PQ - - - Q Q Q - Covance 6329-223 3M T-6295.7 731 Appendix 4 Individual Clinical Urinalysis Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 52.0 1.017 7.0 100.0 1.020 7.0 57.0 1.020 7.5 45.0 1.023 7.0 240.0 1.007 7.5 50.0 1.023 8.0 MEAN S.D. N 90.7 75.84 6 1.018 .0060 6 7.3 .41 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 225.0 1.007 7.5 48.0 1.023 7.0 45.0 1.024 7.0 52.0 1.023 7.0 MEAN S.D. N 92.5 88.38 4 1.019 .0082 4 7.1 .25 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 140.0 1.012 8.0 61.0 1.023 7.5 53.0 1.026 8.0 62.0 1.018 7.0 64.0 1.020 8.0 51.0 1.025 8.0 MEAN S.D. N 71.8 33.80 6 1.021 .0052 6 7.8 .42 6 Covance 6329-223 3M T-6295.7 732 Appendix 4 Individual Clinical Urinalysis Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 35.0 1.026 7.5 59.0 1.024 8.0 64.0 1.023 7.5 247.0 1.007 7.0 72.0 1.019 7.0 51.0 1.021 7.0 MEAN S.D. N 88.0 78.91 6 1.020 .0068 6 7.3 .41 6 Covance 6329-223 3M T-6295.7 733 Appendix 4 Individual Clinical Urinalysis Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 0 - ++ - - - I05530 10 - - - + - I05531 0 - - - - - I05535 0 - ++ - - - I05544 0 - - - + - I05549 0 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 0 - - - +++ - I05541 0 - + - - - I05547 10 - - - ++ - I05550 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 0 - I05538 0 - I05539 10 - I05545 0 - I05548 0 - I05552 0 - - - + - - - ++ - + - - - - - - - ++ - - - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 10 - +++ - - - I05534 0 - - - - - I05536 0 - - - - - I05540 0 - - - - - I05542 0 - - - - - I05551 0 - + - - - Covance 6329-223 3M T-6295.7 734 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 Group: 2 I05537 I05541 I05547 I05550 Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 Appendix 4 Individual Clinical Urinalysis Data Females Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 1 1 3 1H 3B4D 0 BK 0 0 0 3 0 4B 0 DL 0 0 1 3 0 4B4D 0 CK 0 0 0 3 0 2B2D 0 CL 0 0 2 3 0 4B 0 AK 0 0 0 1 0 4B1D 1E BK Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 1 3 0 4B4D 0 BK 0 1 1 3 0 4B2D 0 DL 0 0 0 3 0 2B 0 DL 0 0 1 2 0 4B1E 0 CK Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 2 2 0 1D4F 0 BJ 0 0 1 2 0 1B1E 1F CK 0 0 1 3 0 4B 0 CK 0 0 1 2 0 4B 0 CK 0 0 0 3 0 2B 0 CL 0 0 2 3 0 4B 0 CL Dose Level: 0.75 Dosage Unit: mg/kg/day 0 1 2 3 0 2B4D 0 DK 0 0 1 2 0 4B4D 0 CL 0 0 1 3 0 3B3D 0 CL 0 0 4 3 0 0 0 AK 0 1 1 3 0 4B1E 0 CK 0 0 1 3 0 4B1D 0 CK COMMENTS -------- P - - - P - - Covance 6329-223 3M T-6295.7 735 Appendix 4 Individual Clinical Urinalysis Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 56.0 1.023 8.0 47.0 1.025 7.0 48.0 1.021 8.0 66.0 1.013 7.0 26.0 1.006 7.5 58.0 1.017 7.5 MEAN S.D. N 50.2 13.75 6 1.018 .0071 6 7.5 .45 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 62.0 1.020 7.0 108.0 1.017 7.5 38.0 1.028 8.0 82.0 1.019 7.5 MEAN S.D. N 72.5 29.73 4 1.021 .0048 4 7.5 .41 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 307.0 1.002 7.0 34.0 1.023 7.5 70.0 1.017 7.5 54.0 1.019 7.5 37.0 1.028 7.0 64.0 1.025 7.0 MEAN S.D. N 94.3 105.16 6 1.019 .0092 6 7.2 .27 6 Covance 6329-223 3M T-6295.7 736 Appendix 4 Individual Clinical Urinalysis Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 50.0 1.023 8.0 52.0 1.026 8.0 36.0 1.023 8.0 110.0 1.008 6.5 146.0 1.007 7.0 80.0 1.018 6.5 MEAN S.D. N 79.0 42.12 6 1.018 .0082 6 7.3 .75 6 Covance 6329-223 3M T-6295.7 737 Appendix 4 Individual Clinical Urinalysis Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 0 - + - - - I05517 0 - ++ - - - I05519 0 - - - - - I05520 0 - +++ - - - I05526 0 - + - - - I05527 0 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 0 - - - - - I05515 0 - - - - - I05516 0 - - - - - I05521 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - - - - - I05510 0 - - - - - I05518 0 - + - - - I05523 0 - - - - - I05524 0 - ++ - - - I05528 0 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 0 - ++ - - - I05507 0 - - - - - I05509 0 - - - - - I05511 0 - + - - - I05512 0 - + - - - I05522 0 - +++ - - - Covance 6329-223 3M T-6295.7 738 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 Group: 2 I05514 I05515 I05516 I05521 Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 Appendix 4 Individual Clinical Urinalysis Data Males Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 2 0 4D 0 BK 0 0 1 2 0 1D 0 CK 0 0 0 2 0 3E3F 0 BK 0 0 1 1 0 0 0 BJ 0 0 0 1 0 1B1D 0 BJ 0 0 0 1 0 4D 0 BJ Dose Level: 0.03 Dosage Unit: mg/kg/day 1 0 1 2 0 2E 0 BK 0 0 0 3 0 4B4D 0 BK 0 0 1 2 0 4B1D 0 CK 0 0 0 2 0 4B2D 1E BL Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 0 0 0 1B 0 AJ 0 0 0 3 0 4D 0 BK 0 0 0 1 0 3D 0 BK 0 0 1 2 0 2D3E 0 BK 0 1 1 1 0 0 0 CK 0 0 0 2 0 4B1E 0 BK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 1 2 0 0 0 BK 0 0 0 1 0 3B4D 0 BK 0 0 1 1 0 0 0 BK 0 0 0 3 0 1B 0 BJ 0 0 0 3 0 2B 0 BJ 0 0 0 2 0 0 0 BK COMMENTS -------- P P PQ P - Q PQ Q - P Q Q Q PQ Covance 6329-223 3M T-6295.7 739 Appendix 4 Individual Clinical Urinalysis Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 14.0 1.010 8.5 20.0 1.003 8.0 31.0 1.026 8.0 564.0 1.001 7.5 38.0 1.020 8.0 44.0 1.021 8.0 MEAN S.D. N 118.5 218.53 6 1.014 .0103 6 8.0 .32 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 170.0 1.011 7.5 46.0 1.020 8.0 76.0 1.016 8.0 55.0 1.024 7.5 MEAN S.D. N 86.8 56.91 4 1.018 .0056 4 7.8 .29 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 78.0 1.014 7.5 186.0 1.006 7.5 66.0 1.019 7.0 85.0 1.012 7.5 47.0 1.024 8.0 40.0 1.026 7.5 MEAN S.D. N 83.7 53.05 6 1.017 .0076 6 7.5 .32 6 Covance 6329-223 3M T-6295.7 740 Appendix 4 Individual Clinical Urinalysis Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 38.0 1.024 8.0 32.0 1.026 8.5 44.0 1.028 8.0 417.0 1.003 8.0 34.0 1.025 7.0 36.0 1.026 7.0 MEAN S.D. N 100.2 155.27 6 1.022 .0094 6 7.8 .61 6 Covance 6329-223 3M T-6295.7 741 Appendix 4 Individual Clinical Urinalysis Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 0 - - - - - I05530 10 - - - ++ - I05531 0 - - - - - I05535 0 - - - +++ - I05544 0 - + - - - I05549 0 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 0 - - - - - I05541 0 - + - - - I05547 0 - - - - - I05550 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 0 - - - - - I05538 0 - - - - - I05539 0 - - - - - I05545 0 - - - - - I05548 0 - + - - - I05552 0 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 0 - + - + - I05534 10 - - - - - I05536 0 - - - - - I05540 0 - - - - - I05542 0 - +++ - - - I05551 0 - - - - - Covance 6329-223 3M T-6295.7 742 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 Group: 2 I05537 I05541 I05547 I05550 Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 Appendix 4 Individual Clinical Urinalysis Data Females Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 2 1 0 1E2F 0 BJ 0 0 0 3 0 4B 0 BLM 0 1 0 2 0 3B4D 0 CL 0 0 1 1 0 0 0 AK 0 0 0 2 0 3B3D 0 BK 0 1 0 3 0 1E1F 0 BK Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 1 2 0 4B 0 BK 0 0 1 2 0 4B4D 0 BK 0 0 0 1 0 2D 0 BK 0 0 0 1 0 1B 0 BK Dose Level: 0.15 Dosage Unit: mg/kg/day 0 1 1 2 0 4B2E 0 BK 0 0 2 1 0 3B 0 BK 0 0 0 3 0 4B3E 0 BK 0 0 1 3 0 4B4D 0 BL 0 0 0 3 0 3B1D 0 BK 0 0 1 1 0 3B1D 1E BL Dose Level: 0.75 Dosage Unit: mg/kg/day 0 1 1 3 0 3B3D 1E BK 0 0 1 1 0 2B4D 0 BK 0 0 0 1 0 4B1D 3E BL 0 0 1 2 0 0 0 AK 0 1 1 1 0 3D 0 BK 0 1 1 2 0 4B1D 0 BK COMMENTS -------- P - P - - P P - Covance 6329-223 3M T-6295.7 743 Appendix 4 Individual Clinical Urinalysis Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 40.0 1.025 8.0 67.0 1.017 8.0 54.0 1.017 8.0 65.0 1.014 7.5 179.0 1.010 8.0 60.0 1.022 8.5 MEAN S.D. N 77.5 50.66 6 1.018 .0054 6 8.0 .32 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 44.0 1.010 8.5 69.0 1.020 8.0 28.0 1.028 7.5 108.0 1.016 8.0 MEAN S.D. N 62.2 34.86 4 1.018 .0076 4 8.0 .41 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 192.0 1.006 8.0 53.0 1.021 8.0 82.0 1.014 8.0 131.0 1.006 7.5 25.0 1.031 8.0 84.0 1.014 7.0 MEAN S.D. N 94.5 59.43 6 1.015 .0095 6 7.8 .42 6 Covance 6329-223 3M T-6295.7 744 Appendix 4 Individual Clinical Urinalysis Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 50.0 1.020 7.5 66.0 1.018 8.0 34.0 1.023 8.0 107.0 1.009 8.0 89.0 1.013 7.5 62.0 1.019 8.5 MEAN S.D. N 68.0 26.39 6 1.017 .0051 6 7.9 .38 6 Covance 6329-223 3M T-6295.7 745 Appendix 4 Individual Clinical Urinalysis Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 10 - ++ - - - I05517 10 - + - - - I05519 0 - - - - - I05520 0 - +++ - - - I05526 0 - + - - - I05527 10 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 0 - - - - - I05515 10 - ++ - - - I05516 10 - ++ - - - I05521 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - I05510 0 - I05518 0 - I05523 0 - I05524 10 - I05528 0 - - - - - - - + - +++ - + - - - - - - - +++ - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 10 - I05507 10 - I05509 10 - I05511 0 - I05512 0 - I05522 10 - +++ - - - - - - - +++ - - - - - - - - - - - - - +++ - Covance 6329-223 3M T-6295.7 746 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 Group: 2 I05514 I05515 I05516 I05521 Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 Appendix 4 Individual Clinical Urinalysis Data Males Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 0 3 0 2B3D 0 CK 0 1 1 2 0 2B2D 0 CK 0 0 1 1 0 2E 0 CK 0 0 1 2 0 2B3D 0 BK 0 0 1 2 0 2B 0 BJ 0 0 1 3 0 2B4D 0 CK Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 1 2 0 2B1E 0 AJ 0 0 1 3 0 2B4D 0 CK 0 0 1 2 0 4D 0 CK 0 0 0 3 0 3B1D 0 BK Dose Level: 0.15 Dosage Unit: mg/kg/day 0 1 0 3 0 4B1D 0 AK 0 0 0 1 0 3B4D 1E CK 0 0 1 3 0 4B3D 0 BK 0 1 1 2 0 2B 0 AK 0 0 1 2 0 2B4D 0 CK 0 0 1 2 0 3B1E 0 BK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 1 1 0 4D 0 CK 0 0 1 2 0 4D 0 CK 0 1 1 1 0 0 0 CK 0 0 1 1 0 2B1D 0 BK 0 0 1 2 0 1D 0 BJ 0 1 0 3 0 1B3D 0 BK COMMENTS -------- Q - Q P - Q P P Q PQ P Q - Covance 6329-223 3M T-6295.7 747 Appendix 4 Individual Clinical Urinalysis Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 62.0 1.020 8.0 68.0 1.022 8.5 31.0 1.024 8.0 195.0 1.005 8.0 60.0 1.016 8.0 30.0 1.026 8.5 MEAN S.D. N 74.3 61.32 6 1.019 .0076 6 8.2 .26 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 97.0 1.015 8.0 18.0 1.028 8.0 50.0 1.018 7.5 49.0 1.021 7.0 MEAN S.D. N 53.5 32.58 4 1.020 .0056 4 7.6 .48 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 98.0 1.010 7.5 56.0 1.022 8.0 47.0 1.022 8.0 98.0 1.016 8.0 30.0 1.028 7.5 45.0 1.020 8.0 MEAN S.D. N 62.3 28.86 6 1.020 .0061 6 7.8 .26 6 Covance 6329-223 3M T-6295.7 748 Appendix 4 Individual Clinical Urinalysis Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 45.0 1.020 7.5 115.0 1.011 8.0 42.0 1.024 7.5 158.0 1.010 8.0 99.0 1.007 7.5 27.0 1.030 7.0 MEAN S.D. N 81.0 51.27 6 1.017 .0091 6 7.6 .38 6 Covance 6329-223 3M T-6295.7 749 Appendix 4 Individual Clinical Urinalysis Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 10 - I05530 10 - I05531 0 - I05535 0 - I05544 0 - I05549 10 - ++++ - - - + - - - ++ - - - - - +++ - - - - - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 10 - - - - - I05541 10 - ++++ - - - I05547 10 - - - - - I05550 10 - ++++ - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 10 - + - - - I05538 10 - - - - - I05539 10 - +++ - - - I05545 0 - - - - - I05548 10 - ++++ - - - I05552 10 - +++ - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 10 - + - - - I05534 0 - - - - - I05536 10 - + - - - I05540 0 - - - - - I05542 0 - - - - - I05551 10 - +++ - - - Covance 6329-223 3M T-6295.7 750 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 Group: 2 I05537 I05541 I05547 I05550 Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 Appendix 4 Individual Clinical Urinalysis Data Females Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 2 0 4D 0 CK 1 0 1 3 0 4B 0 CK 0 1 1 2 0 2B3D 0 CK 0 0 1 2 0 0 0 BJ 0 0 1 1 0 4D1E 0 BK 0 0 1 3 0 2B1D 0 CK Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 1 2 0 2B4D 0 BK 0 1 1 3 0 4B4D 0 CK 0 1 1 1 0 4B2D 0 CK 0 1 2 1 0 2D 0 CK Dose Level: 0.15 Dosage Unit: mg/kg/day 0 4 2 1 0 0 0 BJ 0 0 1 2 0 3B3D 0 CK 0 1 2 1 0 4D 0 CK 0 0 1 1 0 4B1D 0 BK 0 1 1 3 0 4D 0 CK 0 1 0 2 0 2B2D 0 CK Dose Level: 0.75 Dosage Unit: mg/kg/day 1 1 1 2 0 4B2D 0 CK 0 0 2 3 0 4D 0 BK 0 1 1 1 0 3D1E 0 CK 0 1 1 3 0 1B 0 BK 0 1 1 3 0 2B3D 0 AJ 0 1 1 3 0 2B4D 0 CK COMMENTS -------- P P - P P P P P P P - P P P P Covance 6329-223 3M T-6295.7 751 Appendix 4 Individual Clinical Urinalysis Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 46.0 1.023 8.0 40.0 1.026 6.0 60.0 1.017 8.0 43.0 1.023 7.5 52.0 1.026 7.5 44.0 1.031 8.0 MEAN S.D. N 47.5 7.31 6 1.024 .0046 6 7.5 .77 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 29.0 1.010 8.0 I05515 66.0 1.017 8.0 I05516 46.0 1.025 7.5 I05521 a 122.0 1.019 7.5 MEAN S.D. N 65.8 40.43 4 1.018 .0062 4 7.8 .29 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 241.0 1.005 7.0 48.0 1.010 7.0 106.0 1.017 8.0 72.0 1.010 7.0 42.0 1.021 7.5 98.0 1.018 8.0 MEAN S.D. N 101.2 73.16 6 1.014 .0061 6 7.4 .49 6 a Sample collected on Day 92. 752 Covance 6329-223 3M T-6295.7 Appendix 4 Individual Clinical Urinalysis Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 42.0 1.021 6.5 28.0 1.030 8.0 48.0 1.021 8.0 70.0 1.017 8.0 82.0 1.010 6.0 54.0 1.023 7.0 MEAN S.D. N 54.0 19.47 6 1.020 .0066 6 7.2 .88 6 Covance 6329-223 3M T-6295.7 753 Appendix 4 Individual Clinical Urinalysis Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 10 - - - - - I05517 10 - ++++ - - - I05519 10 - + - - - I05520 10 - ++++ - - - I05526 10 - + - - - I05527 10 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 0 - - - - - I05515 10 - - - - - I05516 10 - - - - - I05521 a 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - - - - - I05510 0 - - - - - I05518 0 - - - - - I05523 0 - - - - - I05524 10 - ++ - - - I05528 0 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 10 - ++++ - - - I05507 10 - - - - - I05509 0 - - - - - I05511 0 - - - - - I05512 0 - ++ - - - I05522 10 - - - - - a Sample collected on Day 92. Covance 6329-223 3M T-6295.7 754 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 Group: 2 I05514 I05515 I05516 I05521 a Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 Appendix 4 Individual Clinical Urinalysis Data Males Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 0 3 0 3D2F 0 CK 0 0 2 3 0 4B 0 CK 0 0 0 3 0 3B1D 1F BK 0 0 0 3 0 4B4D 1E BK 0 0 0 2 0 1B4D 0 CK 0 0 0 2 0 4B4D 3E CL Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 0 3 0 4B2E 0 BK 0 0 0 3 0 4B1D 0 BK 0 0 1 3 0 1D 0 CK 0 0 0 1 0 4B2E 0 CK Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 1 2 0 0 0 AJ 0 1 0 3 0 3B 0 BK 0 0 0 3 0 2B1E 0 BL 0 1 0 3 0 4B 0 AK 0 0 1 2 0 0 0 CK 0 0 0 2 0 3B2E 1F BK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 1 1 2 0 0 0 CK 0 0 0 1 0 4B4D 1E CL 0 0 0 3 0 1B 0 BJ 0 0 0 2 0 3B1E 0 BL 0 0 1 2 0 0 0 BJ 0 0 1 1 0 4D 0 BJ COMMENTS -------- P - Q Q PQ PQ PQ P Q PQ Q P Q Covance 6329-223 3M T-6295.7 a Sample collected on Day 92. 755 Appendix 4 Individual Clinical Urinalysis Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 45.0 1.016 8.0 67.0 1.020 8.0 62.0 1.019 8.0 229.0 1.006 8.0 65.0 1.018 8.0 92.0 1.012 8.0 MEAN S.D. N 93.3 68.15 6 1.015 .0053 6 8.0 .00 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 104.0 1.017 7.0 31.0 1.021 7.5 60.0 1.014 7.0 64.0 1.021 8.0 MEAN S.D. N 64.8 30.02 4 1.018 .0034 4 7.4 .48 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 102.0 1.011 8.0 74.0 1.012 7.0 56.0 1.026 7.5 48.0 1.014 6.5 61.0 1.020 8.0 38.0 1.028 8.0 MEAN S.D. N 63.2 22.56 6 1.018 .0073 6 7.5 .63 6 Covance 6329-223 3M T-6295.7 756 Appendix 4 Individual Clinical Urinalysis Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 30.0 1.025 8.0 46.0 1.023 8.0 268.0 1.005 8.0 295.0 1.005 8.0 38.0 1.022 7.0 46.0 1.024 7.5 MEAN S.D. N 120.5 125.14 6 1.017 .0096 6 7.8 .42 6 Covance 6329-223 3M T-6295.7 757 Appendix 4 Individual Clinical Urinalysis Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 10 - - - - - I05530 10 - - - +++ - I05531 10 - - - - - I05535 10 - - - - - I05544 10 - - - - - I05549 0 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 0 - - - - - I05541 10 - + - - - I05547 0 - - - - - I05550 30 - - - +++ - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 10 - - - - - I05538 0 - + - + - I05539 10 - - - - - I05545 0 - + - - - I05548 10 - + - - - I05552 10 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 10 - + - - - I05534 10 - - - - - I05536 0 - - - - - I05540 0 - - - - - I05542 10 - ++ - - - I05551 10 - - - - - Covance 6329-223 3M T-6295.7 758 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 Group: 2 I05537 I05541 I05547 I05550 Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 Appendix 4 Individual Clinical Urinalysis Data Females Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 0 3 0 3B4D 0 BK 4 0 0 3 0 3B4D 0 BL 0 0 0 3 0 4B2E 0 BL 0 0 1 3 0 2B1F 0 BJ 0 0 0 3 0 2B 0 BL 0 0 1 3 0 2B1D 1E BK Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 1 2 0 3B1D 1E BK 0 0 1 3 0 4B4D 1E1F BL 0 0 0 3 0 3B1D 0 BL 4 0 1 3 0 3B 0 CL Dose Level: 0.15 Dosage Unit: mg/kg/day 0 1 4 3 0 1B4D 0 BK 0 0 2 3 0 3D 0 BK 0 0 0 2 0 4B2E 0 BL 0 0 1 1 0 0 0 BK 0 0 1 1 0 4B4D 0 BL 0 0 1 1 0 4B1D 1E CL Dose Level: 0.75 Dosage Unit: mg/kg/day 0 3 1 3 0 4D 0 CK 0 0 0 2 0 4B4D 0 BL 0 0 1 2 0 3D 0 AJ 0 0 2 3 0 0 0 AK 0 2 1 3 0 2B2D 0 BK 0 0 1 3 0 3B1D 0 BL COMMENTS -------- - P - P - P P - Covance 6329-223 3M T-6295.7 759 Appendix 4 Individual Clinical Urinalysis Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 68.0 1.017 7.5 76.0 1.013 7.0 210.0 1.004 7.5 34.0 1.019 6.5 320.0 1.005 6.5 80.0 1.021 7.5 MEAN S.D. N 131.3 110.42 6 1.013 .0072 6 7.1 .49 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 56.0 1.017 7.5 46.0 1.020 7.0 34.0 1.028 7.0 84.0 1.017 8.0 MEAN S.D. N 55.0 21.32 4 1.020 .0052 4 7.4 .48 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 360.0 1.004 7.5 92.0 1.009 7.0 66.0 1.014 7.0 140.0 1.008 7.0 44.0 1.022 7.0 125.0 1.011 7.0 MEAN S.D. N 137.8 114.54 6 1.011 .0062 6 7.1 .20 6 Covance 6329-223 3M T-6295.7 760 Appendix 4 Individual Clinical Urinalysis Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05509 I05511 I05512 I05522 80.0 1.012 7.0 200.0 1.008 7.5 32.0 1.026 6.0 390.0 1.003 7.0 280.0 1.005 7.5 98.0 1.013 7.5 MEAN S.D. N 180.0 136.48 6 1.011 .0082 6 7.1 .58 6 Covance 6329-223 3M T-6295.7 761 Appendix 4 Individual Clinical Urinalysis Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 0 - - - - - I05517 0 - ++ - - - I05519 0 - - - - - I05520 0 - ++++ - - - I05526 0 - + - - - I05527 0 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 0 - ++ - + - I05515 0 - ++ - - - I05516 0 - - - - - I05521 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - - - - - I05510 0 - - - - - I05518 0 - + - - - I05523 0 - - - - - I05524 0 - ++ - - - I05528 0 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 0 - +++ - - - I05507 0 - - - - - I05509 10 - ++ - - - I05511 0 - - - - - I05512 0 - - - - - I05522 0 - - - - - Covance 6329-223 3M T-6295.7 762 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 Group: 2 I05514 I05515 I05516 I05521 Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 Group: 4 I05506 I05507 I05509 I05511 I05512 I05522 Appendix 4 Individual Clinical Urinalysis Data Males Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 3 0 4B 0 BK 0 0 1 2 0 0 0 BK 0 0 0 2 0 0 0 AJ 0 0 1 3 0 0 0 BK 0 0 1 3 0 0 0 AK 0 0 0 3 0 4B4D 0 BL Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 0 3 0 3B1D 1E BK 0 0 1 3 0 1B1D 1E BK 0 0 1 3 0 4B1D 0 BK 0 0 1 3 0 4B4D 0 BL Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 1 3 0 0 0 AK 0 0 1 3 0 0 0 BK 0 0 0 3 0 4B 0 BK 0 1 1 3 0 0 0 BK 0 0 1 2 0 0 0 BK 0 1 1 3 0 0 0 BK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 1 3 0 2B 0 BK 0 0 0 2 0 0 0 AK 0 1 1 3 0 0 0 BK 0 0 0 2 0 0 0 AK 0 0 1 2 0 0 0 AK 0 0 1 3 0 0 0 BK COMMENTS -------- Q P Q PQ PQ PQ - Q Q Q P - Covance 6329-223 3M T-6295.7 763 Appendix 4 Individual Clinical Urinalysis Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05530 I05531 I05535 I05544 I05549 44.0 1.022 7.5 36.0 1.024 8.0 36.0 1.023 7.5 145.0 1.006 7.0 100.0 1.011 7.5 150.0 1.007 7.5 MEAN S.D. N 85.2 53.91 6 1.016 .0084 6 7.5 .32 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 110.0 1.013 7.0 40.0 1.020 7.0 26.0 1.017 6.5 66.0 1.016 7.5 MEAN S.D. N 60.5 36.93 4 1.016 .0029 4 7.0 .41 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 44.0 1.023 7.0 46.0 1.027 7.0 54.0 1.018 7.0 46.0 1.018 7.0 28.0 1.022 7.5 26.0 1.027 7.0 MEAN S.D. N 40.7 11.15 6 1.022 .0040 6 7.1 .20 6 Covance 6329-223 3M T-6295.7 764 Appendix 4 Individual Clinical Urinalysis Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 30.0 1.025 7.0 52.0 1.011 8.0 110.0 1.012 7.5 270.0 1.005 6.0 36.0 1.021 7.0 36.0 1.026 7.0 MEAN S.D. N 89.0 93.46 6 1.017 .0085 6 7.1 .66 6 Covance 6329-223 3M T-6295.7 765 Appendix 4 Individual Clinical Urinalysis Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 10 - + - +++ - I05530 10 - - - - - I05531 0 - + - - - I05535 0 - + - - - I05544 0 - - - - - I05549 0 - - - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 0 - I05541 30 - I05547 10 - I05550 0 - + - ++ - ++++ - + - - - +++ - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 0 - + - - - I05538 0 - +++ - - - I05539 0 - + - - - I05545 0 - ++ - - - I05548 10 - +++ - - - I05552 0 - +++ - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 0 - +++ - - - I05534 0 - - - - - I05536 0 - - - - - I05540 0 - + - - - I05542 0 - ++ - - - I05551 0 - ++ - - - Covance 6329-223 3M T-6295.7 766 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 Group: 2 I05537 I05541 I05547 I05550 Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 Appendix 4 Individual Clinical Urinalysis Data Females Day 153 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 2 1 0 3 0 3B1D 0 BL 0 1 0 3 0 4B4D 0 BL 0 0 0 2 0 4B4D 2E4F BL 0 0 1 2 0 0 0 BK 0 0 1 3 0 4B 0 BL 0 0 2 3 0 0 0 BK Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 1 3 0 2B4D 0 BK 4 1 1 3 0 0 0 CK 0 1 1 3 0 3B2E 0 BL 0 0 2 3 0 0 0 BK Dose Level: 0.15 Dosage Unit: mg/kg/day 0 4 2 2 0 0 0 BK 0 0 1 1 0 1D 0 CK 0 1 3 3 0 1D 0 BK 0 0 2 3 0 4D 0 BK 0 1 1 3 0 4B4D 0 BL 0 0 1 3 0 4D 0 CK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 1 1 3 0 2B2D 0 BK 0 0 1 3 0 2B4D 0 BK 0 1 1 2 0 4B3D 1E BL 0 1 2 1 0 0 0 AK 0 2 1 3 0 2B4D 0 BK 0 1 1 3 0 3B4D 0 CK COMMENTS -------- P - P P - P P P P - Covance 6329-223 3M T-6295.7 767 Appendix 4 Individual Clinical Urinalysis Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05517 I05519 I05520 I05526 I05527 184.0 1.006 8.0 49.0 1.021 7.5 62.0 1.012 8.0 102.0 1.013 8.0 242.0 1.006 8.0 58.0 1.023 8.0 MEAN S.D. N 116.2 79.33 6 1.014 .0072 6 7.9 .20 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 94.0 1.014 8.0 52.0 1.019 7.5 54.0 1.018 8.0 102.0 1.016 8.0 MEAN S.D. N 75.5 26.20 4 1.017 .0022 4 7.9 .25 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05510 I05518 I05523 I05524 I05528 368.0 1.003 8.0 122.0 1.012 8.0 78.0 1.016 8.5 21.0 1.017 6.0 49.0 1.015 6.5 96.0 1.016 8.0 MEAN S.D. N 122.3 125.43 6 1.013 .0053 6 7.5 1.00 6 Covance 6329-223 3M T-6295.7 768 Appendix 4 Individual Clinical Urinalysis Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05507 I05511 I05512 I05522 280.0 1.005 7.5 96.0 1.017 8.0 36.0 1.018 6.5 72.0 1.012 7.0 MEAN S.D. N 121.0 108.83 4 1.013 .0059 4 7.2 .65 4 Covance 6329-223 3M T-6295.7 769 Appendix 4 Individual Clinical Urinalysis Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 10 - - - - - I05517 10 - - - - - I05519 10 - - - - - I05520 10 - - - - - I05526 10 - - - - - I05527 10 - + - - - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 10 - - - - - I05515 10 - - - - - I05516 10 - - - - - I05521 10 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 10 - - - - - I05510 10 - - - - - I05518 10 - - - - - I05523 10 - ++ - - - I05524 10 - - - - - I05528 10 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05507 10 - - - - - I05511 10 - - - - - I05512 10 - - - - - I05522 10 - - - - - Covance 6329-223 3M T-6295.7 770 ANIMAL NUMBER ------ Group: 1 I05508 I05517 I05519 I05520 I05526 I05527 Group: 2 I05514 I05515 I05516 I05521 Group: 3 I05505 I05510 I05518 I05523 I05524 I05528 Group: 4 I05507 I05511 I05512 I05522 Appendix 4 Individual Clinical Urinalysis Data Males Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 0 3 0 2B1E 0 BK 0 0 0 2 0 3B3D 0 BL 0 0 0 3 0 4B 0 BK 0 0 0 3 0 3B1D 0 BL 0 1 0 3 0 2B 0 AK 0 0 0 3 0 4B4D 0 BL Dose Level: 0.03 Dosage Unit: mg/kg/day 0 0 0 2 0 2B2E 0 BK 0 0 0 3 0 4B1E 0 BK 0 0 1 3 0 2B 0 BK 0 0 0 3 0 4B 0 BL Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 0 3 0 2B 0 AK 0 0 1 3 0 2B1E 0 BK 0 0 0 3 0 4B4D 0 BK 0 0 0 1 0 1B 0 BJ 0 0 0 3 0 0 0 BK 0 0 0 1 0 4B1E 0 BL Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 0 1 0 0 0 AJ 0 0 1 2 0 4B 0 BK 0 0 0 2 0 0 0 BJ 0 0 1 2 0 2D 0 BK COMMENTS -------- - Q - P - Q Q P PQ Covance 6329-223 3M T-6295.7 771 Appendix 4 Individual Clinical Urinalysis Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 Dose Level: 50.0 62.0 57.0 159.0 86.0 100.0 0 1.020 1.015 1.023 1.009 1.017 1.013 Dosage 8.0 8.0 8.5 8.0 8.0 8.0 Unit: mg/kg/day MEAN S.D. N 85.7 40.59 6 1.016 .0050 6 8.1 .20 6 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 I05541 I05547 I05550 108.0 1.013 7.0 38.0 1.020 7.5 95.0 1.009 8.0 64.0 1.020 8.0 MEAN S.D. N 76.2 31.48 4 1.016 .0054 4 7.6 .48 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05539 I05545 I05548 I05552 118.0 1.010 8.0 61.0 1.021 8.0 70.0 1.022 8.0 66.0 1.013 7.5 82.0 1.014 8.0 43.0 1.023 8.0 MEAN S.D. N 73.3 25.33 6 1.017 .0055 6 7.9 .20 6 Covance 6329-223 3M T-6295.7 772 Appendix 4 Individual Clinical Urinalysis Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05534 I05536 I05540 I05542 I05551 47.0 1.016 7.5 82.0 1.015 8.0 72.0 1.017 8.0 450.0 1.003 7.5 84.0 1.018 8.0 56.0 1.018 8.0 MEAN S.D. N 131.8 156.54 6 1.014 .0058 6 7.8 .26 6 Covance 6329-223 3M T-6295.7 773 Appendix 4 Individual Clinical Urinalysis Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 10 - - - - - I05530 10 - - - - - I05531 10 - - - - - I05535 10 - - - - - I05544 10 - - - - - I05549 10 - - - + - Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 10 - ++ - - - I05541 10 - ++ - - - I05547 10 - - - - - I05550 10 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 10 - - - - - I05538 10 - - - - - I05539 10 - - - - - I05545 10 - - - - - I05548 10 - - - - - I05552 10 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 30 - I05534 10 - I05536 10 - I05540 10 - I05542 10 - I05551 10 - +++ - - - - - - - - - - - +++ - + - - - - - - - - - Covance 6329-223 3M T-6295.7 774 ANIMAL NUMBER ------ Group: 1 I05529 I05530 I05531 I05535 I05544 I05549 Group: 2 I05537 I05541 I05547 I05550 Group: 3 I05532 I05538 I05539 I05545 I05548 I05552 Group: 4 I05533 I05534 I05536 I05540 I05542 I05551 Appendix 4 Individual Clinical Urinalysis Data Females Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 3 0 4B1D 0 BL 0 0 0 3 0 4B2D 0 BL 0 0 1 3 1G 4B1E 0 BK 0 0 1 3 0 4D 0 BK 0 0 1 3 0 4B 0 BL 0 1 1 3 0 2B1D 0 BK Dose Level: 0.03 Dosage Unit: mg/kg/day 0 1 1 3 0 3B2E 0 BK 0 1 1 3 0 3B1E 0 BL 0 0 1 3 0 4B 0 BK 0 0 1 3 0 4B1E 0 BL Dose Level: 0.15 Dosage Unit: mg/kg/day 0 3 0 3 0 2B2E 0 BK 0 0 1 2 0 4B2E 1F BL 0 0 0 1 0 3B1E 0 BL 0 0 1 2 0 2B2D 0 BK 0 0 1 3 0 3B 0 BK 0 1 1 3 0 3B3D 0 BL Dose Level: 0.75 Dosage Unit: mg/kg/day 2 0 1 3 0 0 0 BK 0 1 1 3 0 3B 0 BL 0 0 2 2 0 4B3D 0 BL 0 0 1 2 0 1B 0 AK 0 0 0 3 0 4B 0 BK 0 1 1 3 0 3B3D 0 BL COMMENTS -------- - P - - - Covance 6329-223 3M T-6295.7 775 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 162.0 1.010 7.5 197.0 1.010 7.0 MEAN S.D. N 179.5 24.75 2 1.010 .0000 2 7.2 .35 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 296.0 1.005 7.5 183.0 1.009 7.5 MEAN S.D. N 239.5 79.90 2 1.007 .0028 2 7.5 .00 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 62.0 1.011 6.5 113.0 1.015 7.5 MEAN S.D. N 87.5 36.06 2 1.013 .0028 2 7.0 .71 2 Covance 6329-223 3M T-6295.7 776 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 0 - - - - - I05526 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - - - - - I05523 0 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 0 - - - + - I05522 0 - - - - - Covance 6329-223 3M T-6295.7 777 ANIMAL NUMBER ------ Group: 1 I05520 I05526 Group: 3 I05505 I05523 Group: 4 I05511 I05522 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 1 0 1 0 4B BK 0 0 1 2 0 4B BJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 0 2 0 2B AJ 0 0 0 2 0 2B AK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 1 3 0 3B BK 0 0 0 3 0 3B BK COMMENTS -------- Q Q - Covance 6329-223 3M T-6295.7 778 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 88.0 1.020 8.0 198.0 1.009 7.5 MEAN S.D. N 143.0 77.78 2 1.014 .0078 2 7.8 .35 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 178.0 1.015 7.5 64.0 1.015 7.0 MEAN S.D. N 121.0 80.61 2 1.015 .0000 2 7.2 .35 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 63.0 1.015 7.0 115.0 1.015 8.0 MEAN S.D. N 89.0 36.77 2 1.015 .0000 2 7.5 .71 2 Covance 6329-223 3M T-6295.7 779 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 0 - - - - - I05549 0 - - - + - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 10 - - - +++ - I05552 10 - + - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 0 - + - - - I05542 0 - - - - - Covance 6329-223 3M T-6295.7 780 ANIMAL NUMBER ------ Group: 1 I05529 I05549 Group: 3 I05539 I05552 Group: 4 I05533 I05542 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 3 0 4B CK 0 0 0 3 0 3B AK Dose Level: 0.15 Dosage Unit: mg/kg/day 4 0 1 3 0 4B3E BK 0 0 1 3 0 4B BK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 1 3 0 4B BK 0 0 0 3 0 3B BK COMMENTS -------- - - P - Covance 6329-223 3M T-6295.7 781 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 202.0 1.008 7.5 189.0 1.010 8.0 MEAN S.D. N 195.5 9.19 2 1.009 .0014 2 7.8 .35 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 290.0 1.005 7.5 102.0 1.014 7.5 MEAN S.D. N 196.0 132.94 2 1.010 .0064 2 7.5 .00 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 62.0 1.014 7.5 104.0 1.020 8.0 MEAN S.D. N 83.0 29.70 2 1.017 .0042 2 7.8 .35 2 Covance 6329-223 3M T-6295.7 782 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 0 - - - - - I05526 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - - - - - I05523 0 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 0 - - - - - I05522 10 - - - - - Covance 6329-223 3M T-6295.7 783 ANIMAL NUMBER ------ Group: 1 I05520 I05526 Group: 3 I05505 I05523 Group: 4 I05511 I05522 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 3 0 0 0 AJ 0 0 0 3 0 1D 0 AJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 0 3 0 0 0 AJ 0 1 1 2 1H 2B2F 0 AJ Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 1 2 0 3D 0 BJ 0 0 0 3 0 4B 0 BL COMMENTS -------- Q - PQ - Covance 6329-223 3M T-6295.7 784 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 46.0 1.026 8.0 188.0 1.010 8.0 MEAN S.D. N 117.0 100.41 2 1.018 .0113 2 8.0 .00 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 176.0 1.015 7.0 87.0 1.018 7.5 MEAN S.D. N 131.5 62.93 2 1.016 .0021 2 7.2 .35 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 57.0 1.014 7.5 126.0 1.019 8.0 MEAN S.D. N 91.5 48.79 2 1.016 .0035 2 7.8 .35 2 Covance 6329-223 3M T-6295.7 785 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 10 - - - - - I05549 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 0 - - - - - I05552 0 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 10 - + - - - I05542 0 - - - - - Covance 6329-223 3M T-6295.7 786 ANIMAL NUMBER ------ Group: 1 I05529 I05549 Group: 3 I05539 I05552 Group: 4 I05533 I05542 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- CRYSTALS PER LPF2 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 0 3 0 3B1D 1E BK 0 0 1 3 0 2B 0 BJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 1 3 0 1B 0 BJ 0 0 1 1 0 4B1E 0 BL Dose Level: 0.75 Dosage Unit: mg/kg/day 0 1 1 3 0 2B1D 0 BK 0 0 1 2 0 3B2E 2F BL COMMENTS -------- - - - Covance 6329-223 3M T-6295.7 787 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 248.0 1.004 6.5 320.0 1.003 7.0 MEAN S.D. N 284.0 50.91 2 1.004 .0007 2 6.8 .35 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 354.0 1.004 7.5 114.0 1.010 7.0 MEAN S.D. N 234.0 169.71 2 1.007 .0042 2 7.2 .35 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 32.0 1.026 6.5 103.0 1.011 7.5 MEAN S.D. N 67.5 50.20 2 1.018 .0106 2 7.0 .71 2 Covance 6329-223 3M T-6295.7 788 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 0 - - - - - I05526 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - - - - - I05523 10 - - - +++ - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 10 - + - - - I05522 0 - - - - - Covance 6329-223 3M T-6295.7 789 ANIMAL NUMBER ------ Group: 1 I05520 I05526 Group: 3 I05505 I05523 Group: 4 I05511 I05522 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 0 3 0 0 AJ 0 0 1 2 0 0 AJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 0 3 0 0 AJ 0 0 0 3 0 0 BJ Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 0 2 0 1B4E BJ 0 0 0 3 0 1B BJ COMMENTS -------- - PQ - Covance 6329-223 3M T-6295.7 790 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 118.0 1.007 7.5 165.0 1.005 8.0 MEAN S.D. N 141.5 33.23 2 1.006 .0014 2 7.8 .35 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 90.0 1.016 7.5 37.0 1.023 7.5 MEAN S.D. N 63.5 37.48 2 1.020 .0050 2 7.5 .00 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 23.0 1.011 8.0 106.0 1.010 6.5 MEAN S.D. N 64.5 58.69 2 1.010 .0007 2 7.2 1.06 2 Covance 6329-223 3M T-6295.7 791 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 0 - - - - - I05549 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 10 - - - - - I05552 10 - ++ - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 10 - - - - - I05542 0 - ++ - - - Covance 6329-223 3M T-6295.7 792 ANIMAL NUMBER ------ Group: 1 I05529 I05549 Group: 3 I05539 I05552 Group: 4 I05533 I05542 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 3 0 0 AJ 0 0 1 3 0 1D AJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 1 1 3 0 1B2E BJ 0 0 1 3 0 4B BL Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 0 3 0 4B BL 0 0 1 3 0 1B BJ COMMENTS -------- P - - P Covance 6329-223 3M T-6295.7 793 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 116.0 1.015 6.5 476.0 1.002 7.0 MEAN S.D. N 296.0 254.56 2 1.008 .0092 2 6.8 .35 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 166.0 1.009 7.0 33.0 1.023 6.0 MEAN S.D. N 99.5 94.05 2 1.016 .0099 2 6.5 .71 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 51.0 1.013 6.0 44.0 1.026 6.0 MEAN S.D. N 47.5 4.95 2 1.020 .0092 2 6.0 .00 2 Covance 6329-223 3M T-6295.7 794 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 0 - +++ - - - I05526 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - - - - - I05523 0 - +++ - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 0 - ++++ - - - I05522 0 - ++++ - - - Covance 6329-223 3M T-6295.7 795 ANIMAL NUMBER ------ Group: 1 I05520 I05526 Group: 3 I05505 I05523 Group: 4 I05511 I05522 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 1 0 1B BJ 0 0 1 1 0 0 AJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 1 1 3 0 3B BJ 0 0 1 3 0 2B BJ Dose Level: 0.75 Dosage Unit: mg/kg/day 0 1 1 2 0 2B BJ 0 0 0 2 0 0 BJ COMMENTS -------- Q - Q Q Covance 6329-223 3M T-6295.7 796 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 87.0 1.010 8.0 354.0 1.003 8.0 MEAN S.D. N 220.5 188.80 2 1.006 .0050 2 8.0 .00 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 76.0 1.015 7.0 42.0 1.021 6.0 MEAN S.D. N 59.0 24.04 2 1.018 .0042 2 6.5 .71 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 71.0 1.017 6.5 113.0 1.012 7.0 MEAN S.D. N 92.0 29.70 2 1.014 .0035 2 6.8 .35 2 Covance 6329-223 3M T-6295.7 797 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 0 - - - - - I05549 10 - - - ++ - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 0 - ++ - - - I05552 0 - +++++ - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 10 - I05542 0 - +++ - - - ++ - - - Covance 6329-223 3M T-6295.7 798 ANIMAL NUMBER ------ Group: 1 I05529 I05549 Group: 3 I05539 I05552 Group: 4 I05533 I05542 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- URINE APP1 -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 1 1 2 0 2B BJ 0 0 1 3 0 0 AJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 1 1 3 0 1D BK 0 0 1 3 0 1B CJ Dose Level: 0.75 Dosage Unit: mg/kg/day 0 1 1 2 0 0 BJ 0 1 1 1 0 0 BJ COMMENTS -------- - - - Covance 6329-223 3M T-6295.7 799 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL SP GR U PH ML -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 149.0 1.019 8.0 264.0 1.015 7.5 MEAN S.D. N 206.5 81.32 2 1.017 .0028 2 7.8 .35 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 82.0 1.018 8.0 67.0 1.018 7.0 MEAN S.D. N 74.5 10.61 2 1.018 .0000 2 7.5 .71 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 100.0 1.015 7.5 80.0 1.022 6.0 MEAN S.D. N 90.0 14.14 2 1.018 .0050 2 6.8 1.06 2 Covance 6329-223 3M T-6295.7 800 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO U GLU U KET U BILI U BLOOD UROBILI MG/DL -------- -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 10 ++++ - - + - I05526 10 + - - + - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 + I05523 10 - - - ++ - + - +++ - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 10 - - - ++ - I05522 10 + - - +++ - Covance 6329-223 3M T-6295.7 801 ANIMAL NUMBER ------ Group: 1 I05520 I05526 Group: 3 I05505 I05523 Group: 4 I05511 I05522 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC WBC EPITH BACT CASTS CRYSTALS CRYSTALS URINE PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2 APP1 -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 1 1 3 0 3B1E 1K BL 0 0 1 3 0 3B1K 0 BL Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 1 2 0 3B3D 0 BL 0 1 1 3 0 3B3D 0 CK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 0 3 0 4B3D 0 BK 0 0 1 3 0 3B 0 BL COMMENTS -------- Q - - Covance 6329-223 3M T-6295.7 802 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL SP GR U PH ML -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 166.0 1.011 8.0 150.0 1.011 8.0 MEAN S.D. N 158.0 11.31 2 1.011 .0000 2 8.0 .00 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 78.0 1.020 7.0 59.0 1.022 7.0 MEAN S.D. N 68.5 13.44 2 1.021 .0014 2 7.0 .00 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 43.0 1.018 6.5 109.0 1.019 7.5 MEAN S.D. N 76.0 46.67 2 1.018 .0007 2 7.0 .71 2 Covance 6329-223 3M T-6295.7 803 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO U GLU U KET U BILI U BLOOD UROBILI MG/DL -------- -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 0 + - - + - I05549 0 + - - + - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 10 - I05552 10 + + - ++ - +++ - ++ - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 10 - I05542 10 + ++ - + - ++ - + - Covance 6329-223 3M T-6295.7 804 ANIMAL NUMBER ------ Group: 1 I05529 I05549 Group: 3 I05539 I05552 Group: 4 I05533 I05542 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC WBC EPITH BACT CASTS CRYSTALS CRYSTALS URINE PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2 APP1 -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 0 3 0 4B2D 3K BL 0 0 1 3 0 4B1D 0 BL Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 1 3 0 4K 0 BK 0 0 1 3 0 3B1D 0 BL Dose Level: 0.75 Dosage Unit: mg/kg/day 0 1 1 3 0 2B 0 BK 0 0 0 3 0 3B3K 0 BL COMMENTS -------- - - - Covance 6329-223 3M T-6295.7 805 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL SP GR U PH ML -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 100.0 1.012 8.0 270.0 1.008 8.0 MEAN S.D. N 185.0 120.21 2 1.010 .0028 2 8.0 .00 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 286.0 1.004 8.0 78.0 1.011 8.0 MEAN S.D. N 182.0 147.08 2 1.008 .0050 2 8.0 .00 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 90.0 1.008 8.0 78.0 1.015 8.0 MEAN S.D. N 84.0 8.49 2 1.012 .0050 2 8.0 .00 2 Covance 6329-223 3M T-6295.7 806 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO U GLU U KET U BILI U BLOOD UROBILI MG/DL -------- -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 0 - - - - - I05526 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - - - - - I05523 10 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 0 - - - - - I05522 0 - - - - - Covance 6329-223 3M T-6295.7 807 ANIMAL NUMBER ------ Group: 1 I05520 I05526 Group: 3 I05505 I05523 Group: 4 I05511 I05522 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC WBC EPITH BACT CASTS CRYSTALS CRYSTALS URINE PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2 APP1 -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 0 3 0 1B1D 0 BK 0 0 1 3 0 0 0 AJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 0 2 0 0 0 AJ 0 0 0 3 0 4B1D 0 BK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 1 3 0 0 0 BJ 0 0 0 3 0 2B4D 0 BJ COMMENTS -------- - Q - Q - Covance 6329-223 3M T-6295.7 808 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL SP GR U PH ML -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 98.0 1.013 8.0 330.0 1.005 8.0 MEAN S.D. N 214.0 164.05 2 1.009 .0057 2 8.0 .00 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 198.0 1.008 7.5 92.0 1.014 8.0 MEAN S.D. N 145.0 74.95 2 1.011 .0042 2 7.8 .35 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 60.0 1.002 8.0 176.0 1.008 8.0 MEAN S.D. N 118.0 82.02 2 1.005 .0042 2 8.0 .00 2 Covance 6329-223 3M T-6295.7 809 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO U GLU U KET U BILI U BLOOD UROBILI MG/DL -------- -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 0 - - - - - I05549 10 - - - +++ - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 0 - - - - - I05552 0 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 0 - - - - - I05542 0 - - - + - Covance 6329-223 3M T-6295.7 810 ANIMAL NUMBER ------ Group: 1 I05529 I05549 Group: 3 I05539 I05552 Group: 4 I05533 I05542 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC WBC EPITH BACT CASTS CRYSTALS CRYSTALS URINE PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2 APP1 -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 3 0 2B4D 0 BK 0 1 1 3 0 0 0 AJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 1 1 3 0 0 0 AJ 0 0 1 3 0 3B 0 BK Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 1 3 0 2B 0 AK 0 0 0 3 0 4B 0 AL COMMENTS -------- - - - Covance 6329-223 3M T-6295.7 811 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL SP GR U PH ML -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 480.0 1.005 8.0 380.0 1.005 8.0 MEAN S.D. N 430.0 70.71 2 1.005 .0000 2 8.0 .00 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 405.0 1.004 7.5 195.0 1.008 8.0 MEAN S.D. N 300.0 148.49 2 1.006 .0028 2 7.8 .35 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 345.0 1.005 8.0 100.0 1.015 8.0 MEAN S.D. N 222.5 173.24 2 1.010 .0071 2 8.0 .00 2 Covance 6329-223 3M T-6295.7 812 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO U GLU U KET U BILI U BLOOD UROBILI MG/DL -------- -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 0 - - - - - I05526 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 0 - - - - - I05523 0 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 0 - - - - - I05522 0 - - - - - Covance 6329-223 3M T-6295.7 813 ANIMAL NUMBER ------ Group: 1 I05520 I05526 Group: 3 I05505 I05523 Group: 4 I05511 I05522 APPENDIX 4 Individual Clinical Urinalysis Data Males Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC WBC EPITH BACT CASTS CRYSTALS CRYSTALS URINE PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2 APP1 -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 0 1 1 0 1B 0 AJ 0 0 0 3 0 1B 0 AJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 0 2 0 0 0 AJ 0 0 0 1 0 2B 0 AJ Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 0 1 0 1B 0 AJ 0 0 0 1 0 2B1D 2E BK COMMENTS -------- Q Q Q - Covance 6329-223 3M T-6295.7 814 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U VOL SP GR U PH ML -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 I05549 105.0 1.015 8.0 160.0 1.007 8.0 MEAN S.D. N 132.5 38.89 2 1.011 .0057 2 8.0 .00 2 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 I05552 85.0 1.017 8.0 50.0 1.019 8.0 MEAN S.D. N 67.5 24.75 2 1.018 .0014 2 8.0 .00 2 Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 I05542 42.0 1.017 8.0 156.0 1.010 8.0 MEAN S.D. N 99.0 80.61 2 1.014 .0050 2 8.0 .00 2 Covance 6329-223 3M T-6295.7 815 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS ANIMAL NUMBER ------ U PRO U GLU U KET U BILI U BLOOD UROBILI MG/DL -------- -------- -------- -------- -------- -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05529 0 - - - - - I05549 0 - - - - - Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05539 10 - - - - - I05552 10 - - - - - Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05533 0 - - - - - I05542 0 - - - +++ - Covance 6329-223 3M T-6295.7 816 ANIMAL NUMBER ------ Group: 1 I05529 I05549 Group: 3 I05539 I05552 Group: 4 I05533 I05542 APPENDIX 4 Individual Clinical Urinalysis Data Females Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS RBC WBC EPITH BACT CASTS CRYSTALS CRYSTALS URINE PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2 APP1 -------- -------- -------- -------- -------- -------- -------- -------- Dose Level: 0 Dosage Unit: mg/kg/day 0 1 0 2 0 2B2D 1F BJ 0 0 0 2 0 2B 0 BJ Dose Level: 0.15 Dosage Unit: mg/kg/day 0 0 0 2 0 3B1E 0 BK 0 0 0 2 0 2B2E 0 BL Dose Level: 0.75 Dosage Unit: mg/kg/day 0 0 0 2 0 3B3D 0 BL 0 1 1 1 0 3B 0 AL COMMENTS -------- - - - Covance 6329-223 3M T-6295.7 817 APPENDIX 5 Covance 6329-223 3M T-6295.7 Individual Palmitoyl CoA Oxidase Determinations Individual Anatomic Pathology Data 818 Appendix 5 Individual Palmitoyl CoA Oxidase Determinations Terminal Sacrifice Males 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 4 I05517 4 I05519 6 I05527 7 MEAN 5 S.D. 1.5 N 4 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 4 I05515 5 I05516 4 I05521 6 MEAN 5 S.D. 1.0 N 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05510 6 I05518 6 I05524 5 I05528 5 MEAN 6 S.D. .6 N 4 Covance 6329-223 3M T-6295.7 819 Appendix 5 Individual Palmitoyl CoA Oxidase Determinations Terminal Sacrifice Males 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05507 8 I05512 6 MEAN 7 S.D. 1.4 N 2 Covance 6329-223 3M T-6295.7 820 Appendix 5 Individual Palmitoyl CoA Oxidase Determinations Terminal Sacrifice Females 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 1 Dose Level: 0 Dosage Unit: mg/kg/day I05530 3 I05531 4 I05535 4 I05544 5 MEAN 4 S.D. .8 N 4 Group: 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05537 4 I05541 4 I05547 2 I05550 5 MEAN 4 S.D. 1.3 N 4 Group: 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 5 I05538 5 I05545 6 I05548 7 MEAN 6 S.D. 1.0 N 4 Covance 6329-223 3M T-6295.7 821 Appendix 5 Individual Palmitoyl CoA Oxidase Determinations Terminal Sacrifice Females 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05534 6 I05536 7 I05540 6 I05551 5 MEAN 6 S.D. .8 N 4 Covance 6329-223 3M T-6295.7 822 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Unscheduled Deaths PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05506 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: UNSCHEDULED (M) DATE OF DEATH: 02/20/99 STUDY DAY OF DEATH: 179 STUDY WEEK OF DEATH: 26 TERMINAL BODY WEIGHT: 3625.0 GRAMS DATE AND TIME OF NECROPSY: 02/20/99 12:40 PROSECTOR: DAVID SCHUETTE RECORDER: NANCY DIEDRICH POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: NANCY DIEDRICH ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .4730 .0130 % .0072 WEIGHT TAKEN RIGHT ADRENAL (AD1) .3840 .0106 % .0058 WEIGHT TAKEN BRAIN (BR) 65.9350 1.8189 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) 1.2760 .0352 % .0194 WEIGHT TAKEN RT EPIDIDYMIS (EP1) 1.2520 .0345 % .0190 WEIGHT TAKEN LF KIDNEY (KD0) 6.1230 .1689 % .0929 WEIGHT TAKEN RT KIDNEY (KD1) 5.9240 .1634 % .0898 WEIGHT TAKEN LIVER (LI) 88.6340 2.4451 % 1.3443 WEIGHT TAKEN LF TESTIS (TE0) 7.0730 .1951 % .1073 WEIGHT TAKEN RT TESTIS (TE1) 7.0020 .1932 % .1062 WEIGHT TAKEN PANCREAS (PA) 6.7010 .1849 % .1016 WEIGHT TAKEN LF THYROID/PARA (TT0) .1980 .0055 % .0030 WEIGHT TAKEN RT THYROID/PARA (TT1) .2070 .0057 % .0031 WEIGHT TAKEN GALLBLADDER (GB) -------- -------- -------- NOT SCHEDULED BILE(VOLUME) (BI) -------- -------- -------- NOT SCHEDULED ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATELY SEVERE BRAIN (BR) : -INFILTRATE, LYMPHOHISTIOCYTIC, PERIVASCULAR,-MINIMAL -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC, MENINGEAL,-SLIGHT KIDNEY (KD) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -CAST, PROTEINACEOUS,-SLIGHT 823 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Unscheduled Deaths PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05506 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: UNSCHEDULED (M) DATE OF DEATH: 02/20/99 STUDY DAY OF DEATH: 179 STUDY WEEK OF DEATH: 26 TERMINAL BODY WEIGHT: 3625.0 GRAMS DATE AND TIME OF NECROPSY: 02/20/99 12:40 PROSECTOR: DAVID SCHUETTE RECORDER: NANCY DIEDRICH POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: NANCY DIEDRICH ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR,-MODERATE, DIFFUSE -STASIS, BILE,-SLIGHT, MULTI-FOCAL THYMUS (TH) : -CYST,-PRESENT -ATROPHY,-MODERATELY SEVERE TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL ESOPHAGUS (ES) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT THYROID (TY) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT -CYST, ULTIMOBRANCHIAL,-PRESENT ADRENAL, CORTEX (AC) : -MINERALIZATION, VASCULAR,-MINIMAL SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT SPINAL CORD (SC) : -INFILTRATION, LYMPHOHISTIOCYTIC MENINGEAL/PERIVASCULAR,- SLIGHT DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 824 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Unscheduled Deaths PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05506 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: UNSCHEDULED (M) DATE OF DEATH: 02/20/99 STUDY DAY OF DEATH: 179 STUDY WEEK OF DEATH: 26 TERMINAL BODY WEIGHT: 3625.0 GRAMS DATE AND TIME OF NECROPSY: 02/20/99 12:40 PROSECTOR: DAVID SCHUETTE RECORDER: NANCY DIEDRICH POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: NANCY DIEDRICH ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- CAUSE OF DEATH (CD) : -UNDETERMINED,-PRESENT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), PANCREAS (PA), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE) ------------------------------------------------------------------------------------------------------------------------------------ 825 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Unscheduled Deaths PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05509 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: UNSCHEDULED (D) DATE OF DEATH: 01/27/99 STUDY DAY OF DEATH: 155 STUDY WEEK OF DEATH: 23 TERMINAL BODY WEIGHT: NOT ENTERED DATE AND TIME OF NECROPSY: 01/27/99 10:21 PROSECTOR: NANCY DIEDRICH RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: NOT AVAILABLE ------------------------------------------------------------------------------------------------------------------------------------ *** ORGAN WEIGHTS WERE NOT RECORDED *** ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATELY SEVERE MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT KIDNEY (KD) : -MINERALIZATION, PAPILLARY,-MODERATE LUNG (LU) : LUNG (LU) : -ADHESION(S); ALL LOBES TO EACH OTHER AND PLEURA: MULTIPLE -FIBROSIS, PLEURAL/SUBPLEURAL,-MODERATE INDISTINCT ADHESIONS; CANNOT DISTINGUISH LOBES FROM ONE -INFILTRATE, MACROPHAGE, ALVEOLAR,-MODERATE ANOTHER; COLLECTED -NECROSIS,-SEVERE -MOTTLED; ALL RIGHT LOBES: RED, DARK RED, AND TAN; LOBES -INFLAMMATION, ACUTE,-SEVERE APPEAR FIRM -FIBRIN, PLEURAL,-MODERATELY SEVERE -EROSION(S)/ULCERATION(S); APPEARS TO BE RIGHT CAUDAL LOBE: SINGLE ULCERATED AREA, 2.5 X 1.5 CM; ULCERATED AREA EXTENDS DEEP INTO LUNG TISSUE; WALLS OF ULCERATION APPEAR GREEN, TAN, GRAY AND MOIST; COLLECTED INTACT LIVER (LI) : LIVER (LI) : -MOTTLED; ALL LOBES: DARK BROWN AND TAN -HYPERTROPHY, HEPATOCELLULAR,-SLIGHT, DIFFUSE -LARGE; ALL LOBES: THICKENED -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE THYMUS (TH) : -ATROPHY,-MODERATE TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 826 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Unscheduled Deaths PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05509 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: UNSCHEDULED (D) DATE OF DEATH: 01/27/99 STUDY DAY OF DEATH: 155 STUDY WEEK OF DEATH: 23 TERMINAL BODY WEIGHT: NOT ENTERED DATE AND TIME OF NECROPSY: 01/27/99 10:21 PROSECTOR: NANCY DIEDRICH RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: NOT AVAILABLE ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT COLON (CO) : COLON (CO) : -DARK FOCUS(I)/AREA(S); WITHIN MUCOSA: SINGLE DARK BROWN >UNREMARKABLE AREA, 0.3 X 0.2 CM; COLLECTED ON ROUTINE SECTION CAUSE OF DEATH (CD) : -NECROSIS, PULMONARY,-PRESENT LN, TRACHEOBRON (TB) : LN, TRACHEOBRON (TB) : -LARGE; UP TO 1.0 X 0.9 X 0.5 CM (CAP 29) -INFLAMMATION, ACUTE,-MODERATE -------------------------------------------- 827 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Unscheduled Deaths PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05509 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: UNSCHEDULED (D) DATE OF DEATH: 01/27/99 STUDY DAY OF DEATH: 155 STUDY WEEK OF DEATH: 23 TERMINAL BODY WEIGHT: NOT ENTERED DATE AND TIME OF NECROPSY: 01/27/99 10:21 PROSECTOR: NANCY DIEDRICH RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: NOT AVAILABLE ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), GENERAL COMMENT (GC), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), LN, MESENTERIC (MS), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), CECUM (CE), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE) ------------------------------------------------------------------------------------------------------------------------------------ 828 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05508 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3285.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 10:24 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2650 .0081 % .0042 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2010 .0061 % .0032 WEIGHT TAKEN BRAIN (BR) 62.3670 1.8985 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) .8310 .0253 % .0133 WEIGHT TAKEN RT EPIDIDYMIS (EP1) 1.0370 .0316 % .0166 WEIGHT TAKEN LF KIDNEY (KD0) 5.8660 .1786 % .0941 WEIGHT TAKEN RT KIDNEY (KD1) 5.4930 .1672 % .0881 WEIGHT TAKEN LIVER (LI) 59.3880 1.8079 % .9522 WEIGHT TAKEN LF TESTIS (TE0) 5.5360 .1685 % .0888 WEIGHT TAKEN RT TESTIS (TE1) 5.1190 .1558 % .0821 WEIGHT TAKEN PANCREAS (PA) 4.3000 .1309 % .0689 WEIGHT TAKEN LF THYROID/PARA (TT0) .1520 .0046 % .0024 WEIGHT TAKEN RT THYROID/PARA (TT1) .1390 .0042 % .0022 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATELY SEVERE KIDNEY (KD) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT -GLOMERULOSCLEROSIS,-MINIMAL LUNG (LU) : LUNG (LU) : -RED FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK RED PINPOINT -HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,- FOCI SLIGHT LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL SPLEEN (SP) : SPLEEN (SP) : -LARGE; 7.0 X 4.0 X 3.0 CM >UNREMARKABLE 829 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05508 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3285.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 10:24 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LN, MESENTERIC (MS) : -HEMORRHAGE,-SLIGHT TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT COLON (CO) : -INFILTRATE, EOSINOPHILIC,-SLIGHT MAMMARY, MALE (MM) : >SECTION EXAMINED; TISSUE NOT PRESENT PROSTATE (PR) : -INFLAMMATION, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.4890 GRAMS BILE VOLUME IS 1.6000 ML -------------------------------------------- 830 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05508 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3285.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 10:24 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), HEART (HT), GALLBLADDER (GB), THYMUS (TH), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), RECTUM (RE), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE) ------------------------------------------------------------------------------------------------------------------------------------ 831 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05517 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3055.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 8:11 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2840 .0093 % .0045 WEIGHT TAKEN RIGHT ADRENAL (AD1) .1430 .0047 % .0023 WEIGHT TAKEN BRAIN (BR) 62.4920 2.0456 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) 1.0930 .0358 % .0175 WEIGHT TAKEN RT EPIDIDYMIS (EP1) 1.2250 .0401 % .0196 WEIGHT TAKEN LF KIDNEY (KD0) 5.9980 .1963 % .0960 WEIGHT TAKEN RT KIDNEY (KD1) 5.7530 .1883 % .0921 WEIGHT TAKEN LIVER (LI) 44.2710 1.4491 % .7084 WEIGHT TAKEN LF TESTIS (TE0) 8.0310 .2629 % .1285 WEIGHT TAKEN RT TESTIS (TE1) 8.1690 .2674 % .1307 WEIGHT TAKEN PANCREAS (PA) 5.8790 .1924 % .0941 WEIGHT TAKEN LF THYROID/PARA (TT0) .1490 .0049 % .0024 WEIGHT TAKEN RT THYROID/PARA (TT1) .1400 .0046 % .0022 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATE MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT LUNG (LU) : -HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,- MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL LN, MESENTERIC (MS) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE 832 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 5 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05517 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3055.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 8:11 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT ADRENAL, CORTEX (AC) : -HYPERTROPHY, CORTICAL CELL,-MINIMAL SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PANCREAS (PA) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL COLON (CO) : -PARASITISM, INTRAMUSCULAR,-PRESENT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.6330 GRAMS BILE VOLUME IS 1.6000 ML -------------------------------------------- 833 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 6 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05517 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3055.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 8:11 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE) ------------------------------------------------------------------------------------------------------------------------------------ 834 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 7 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05519 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3140.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 6:57 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2820 .0090 % .0045 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2330 .0074 % .0037 WEIGHT TAKEN BRAIN (BR) 62.8980 2.0031 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) .7730 .0246 % .0123 WEIGHT TAKEN RT EPIDIDYMIS (EP1) .8270 .0263 % .0131 WEIGHT TAKEN LF KIDNEY (KD0) 5.5490 .1767 % .0882 WEIGHT TAKEN RT KIDNEY (KD1) 5.3860 .1715 % .0856 WEIGHT TAKEN LIVER (LI) 53.1740 1.6934 % .8454 WEIGHT TAKEN LF TESTIS (TE0) 2.7780 .0885 % .0442 WEIGHT TAKEN RT TESTIS (TE1) 2.9990 .0955 % .0477 WEIGHT TAKEN PANCREAS (PA) 5.5570 .1770 % .0883 WEIGHT TAKEN LF THYROID/PARA (TT0) .1310 .0042 % .0021 WEIGHT TAKEN RT THYROID/PARA (TT1) .1220 .0039 % .0019 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATELY SEVERE MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL KIDNEY (KD) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL LUNG (LU) : -HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,- SLIGHT 835 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 8 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05519 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3140.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 6:57 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL GALLBLADDER (GB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT PARATHYROID (PT) : -CYST,-PRESENT ADRENAL, CORTEX (AC) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE CECUM (CE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE MAMMARY, MALE (MM) : >SECTION EXAMINED; TISSUE NOT PRESENT PROSTATE (PR) : -INFLAMMATION, LYMPHOHISTIOCYTIC,-MINIMAL EPIDIDYMIDES (EP) : -HYPOSPERMIA,-MODERATE TESTIS (TE) : -IMMATURE,-PRESENT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS 836 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 9 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05519 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3140.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 6:57 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.7260 GRAMS BILE VOLUME IS 1.2000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), HEART (HT), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), ESOPHAGUS (ES), THYROID (TY), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), COLON (CO), RECTUM (RE), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV) ------------------------------------------------------------------------------------------------------------------------------------ 837 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 10 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05527 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 4680.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 11:00 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3120 .0067 % .0048 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2600 .0056 % .0040 WEIGHT TAKEN BRAIN (BR) 64.8130 1.3849 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) 1.8660 .0399 % .0288 WEIGHT TAKEN RT EPIDIDYMIS (EP1) 1.7750 .0379 % .0274 WEIGHT TAKEN LF KIDNEY (KD0) 7.5090 .1604 % .1159 WEIGHT TAKEN RT KIDNEY (KD1) 7.3890 .1579 % .1140 WEIGHT TAKEN LIVER (LI) 62.8470 1.3429 % .9697 WEIGHT TAKEN LF TESTIS (TE0) 11.5730 .2473 % .1786 WEIGHT TAKEN RT TESTIS (TE1) 10.6940 .2285 % .1650 WEIGHT TAKEN PANCREAS (PA) 6.0920 .1302 % .0940 WEIGHT TAKEN LF THYROID/PARA (TT0) .2380 .0051 % .0037 WEIGHT TAKEN RT THYROID/PARA (TT1) .2750 .0059 % .0042 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-SLIGHT MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL LUNG (LU) : -HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,- SLIGHT LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -GRANULOMA,-MINIMAL, FOCAL 838 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 11 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05527 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 4680.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 11:00 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- THYMUS (TH) : -ATROPHY,-SEVERE SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL MUSCLE, SKELETAL (SM) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE SKIN (SK) : SKIN (SK) : -ABRASION(S)/ULCERATION(S); 2.0 CM FROM TIP OF TAIL: SINGLE -HYPERPLASIA, EPIDERMAL (ACANTHOSIS),-MODERATE RED, MOIST ABRADED AREA, 0.8 CM IN DIAMETER; COLLECTED -INFLAMMATION, CHRONIC-ACTIVE,-SLIGHT -ULCERATION,-MODERATELY SEVERE URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.6430 GRAMS BILE VOLUME IS 2.4000 ML -------------------------------------------- 839 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 12 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05527 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 4680.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 11:00 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), KIDNEY (KD), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), PANCREAS (PA), JEJUNUM (JE), CECUM (CE), COLON (CO), RECTUM (RE), MAMMARY, MALE (MM), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE) ------------------------------------------------------------------------------------------------------------------------------------ 840 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 13 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05514 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3495.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:21 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3620 .0104 % .0058 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2420 .0069 % .0039 WEIGHT TAKEN BRAIN (BR) 62.4280 1.7862 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) 1.1580 .0331 % .0185 WEIGHT TAKEN RT EPIDIDYMIS (EP1) 1.0010 .0286 % .0160 WEIGHT TAKEN LF KIDNEY (KD0) 6.0230 .1723 % .0965 WEIGHT TAKEN RT KIDNEY (KD1) 6.1700 .1765 % .0988 WEIGHT TAKEN LIVER (LI) 64.2170 1.8374 % 1.0287 WEIGHT TAKEN LF TESTIS (TE0) 6.7090 .1920 % .1075 WEIGHT TAKEN RT TESTIS (TE1) 5.1600 .1476 % .0827 WEIGHT TAKEN PANCREAS (PA) 4.7970 .1373 % .0768 WEIGHT TAKEN LF THYROID/PARA (TT0) .3130 .0090 % .0050 WEIGHT TAKEN RT THYROID/PARA (TT1) .3200 .0092 % .0051 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LUNG (LU) : LUNG (LU) : -ADHESION(S); ALL LOBES TO EACH OTHER, PLEURA, PERICARDIAL >NOT REQUIRED TO BE EXAMINED FOR ANIMAL SAC, AND CAUDAL LOBES TO DIAPHRAGM: MULTIPLE RED, TAN, FIBROUS ADHESIONS; COLLECTED INTACT LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL THYMUS (TH) : -ATROPHY,-MODERATE GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS 841 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 14 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05514 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3495.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:21 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.7220 GRAMS BILE VOLUME IS 1.4000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) ------------------------------------------------------------------------------------------------------------------------------------ 842 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 15 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05515 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3475.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 6:45 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2770 .0080 % .0043 WEIGHT TAKEN RIGHT ADRENAL (AD1) .1900 .0055 % .0030 WEIGHT TAKEN BRAIN (BR) 63.7670 1.8350 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) .7590 .0218 % .0119 WEIGHT TAKEN RT EPIDIDYMIS (EP1) .8690 .0250 % .0136 WEIGHT TAKEN LF KIDNEY (KD0) 6.4220 .1848 % .1007 WEIGHT TAKEN RT KIDNEY (KD1) 6.2010 .1784 % .0972 WEIGHT TAKEN LIVER (LI) 55.8260 1.6065 % .8755 WEIGHT TAKEN LF TESTIS (TE0) 2.7190 .0782 % .0426 WEIGHT TAKEN RT TESTIS (TE1) 3.3300 .0958 % .0522 WEIGHT TAKEN PANCREAS (PA) 5.0260 .1446 % .0788 WEIGHT TAKEN LF THYROID/PARA (TT0) .1340 .0039 % .0021 WEIGHT TAKEN RT THYROID/PARA (TT1) .1240 .0036 % .0019 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.4620 GRAMS BILE VOLUME IS 1.2000 ML -------------------------------------------- 843 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 16 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05515 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3475.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 6:45 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: THYMUS (TH) ------------------------------------------------------------------------------------------------------------------------------------ 844 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 17 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05516 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3170.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:15 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2940 .0093 % .0044 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2410 .0076 % .0036 WEIGHT TAKEN BRAIN (BR) 67.0240 2.1143 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) .8820 .0278 % .0132 WEIGHT TAKEN RT EPIDIDYMIS (EP1) .7570 .0239 % .0113 WEIGHT TAKEN LF KIDNEY (KD0) 6.8380 .2157 % .1020 WEIGHT TAKEN RT KIDNEY (KD1) 7.0240 .2216 % .1048 WEIGHT TAKEN LIVER (LI) 68.1040 2.1484 % 1.0161 WEIGHT TAKEN LF TESTIS (TE0) 3.3570 .1059 % .0501 WEIGHT TAKEN RT TESTIS (TE1) 5.1290 .1618 % .0765 WEIGHT TAKEN PANCREAS (PA) 3.0500 .0962 % .0455 WEIGHT TAKEN LF THYROID/PARA (TT0) .2040 .0064 % .0030 WEIGHT TAKEN RT THYROID/PARA (TT1) .1430 .0045 % .0021 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- SPLEEN (SP) : SPLEEN (SP) : -LARGE; 7.0 X 5.0 X 3.0 CM >NOT REQUIRED TO BE EXAMINED FOR ANIMAL THYMUS (TH) : -CYST,-PRESENT TESTIS (TE) : TESTIS (TE) : -LARGE; RIGHT: 2.5 X 1.5 X 1.4 CM (FOR COMPARISON, LEFT IS >NOT REQUIRED TO BE EXAMINED FOR ANIMAL 2.0 X 1.5 X 1.0 CM) GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS 845 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 18 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05516 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3170.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:15 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.6300 GRAMS BILE VOLUME IS 1.4000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) ------------------------------------------------------------------------------------------------------------------------------------ 846 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 19 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05521 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 4385.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 10:48 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3090 .0070 % .0057 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2230 .0051 % .0041 WEIGHT TAKEN BRAIN (BR) 53.9580 1.2305 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) 2.8840 .0658 % .0534 WEIGHT TAKEN RT EPIDIDYMIS (EP1) 2.7980 .0638 % .0519 WEIGHT TAKEN LF KIDNEY (KD0) 7.1230 .1624 % .1320 WEIGHT TAKEN RT KIDNEY (KD1) 7.6030 .1734 % .1409 WEIGHT TAKEN LIVER (LI) 60.2000 1.3729 % 1.1157 WEIGHT TAKEN LF TESTIS (TE0) 18.7540 .4277 % .3476 WEIGHT TAKEN RT TESTIS (TE1) 18.8730 .4304 % .3498 WEIGHT TAKEN PANCREAS (PA) 6.3800 .1455 % .1182 WEIGHT TAKEN LF THYROID/PARA (TT0) .4490 .0102 % .0083 WEIGHT TAKEN RT THYROID/PARA (TT1) .4660 .0106 % .0086 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -VACUOLATION, HEPATOCELLULAR,-MINIMAL, MULTI-FOCAL -STASIS, BILE,-MODERATE, MULTI-FOCAL THYMUS (TH) : -ATROPHY,-MODERATELY SEVERE GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS 847 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 20 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05521 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 4385.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 10:48 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.4810 GRAMS BILE VOLUME IS 1.4000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) ------------------------------------------------------------------------------------------------------------------------------------ 848 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 21 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05510 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3180.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 9:48 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2490 .0078 % .0044 WEIGHT TAKEN RIGHT ADRENAL (AD1) .1600 .0050 % .0028 WEIGHT TAKEN BRAIN (BR) 56.7600 1.7849 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) 1.0910 .0343 % .0192 WEIGHT TAKEN RT EPIDIDYMIS (EP1) 1.0750 .0338 % .0189 WEIGHT TAKEN LF KIDNEY (KD0) 6.4950 .2042 % .1144 WEIGHT TAKEN RT KIDNEY (KD1) 6.1190 .1924 % .1078 WEIGHT TAKEN LIVER (LI) 54.2060 1.7046 % .9550 WEIGHT TAKEN LF TESTIS (TE0) 6.0950 .1917 % .1074 WEIGHT TAKEN RT TESTIS (TE1) 5.8860 .1851 % .1037 WEIGHT TAKEN PANCREAS (PA) 3.8800 .1220 % .0684 WEIGHT TAKEN LF THYROID/PARA (TT0) .1660 .0052 % .0029 WEIGHT TAKEN RT THYROID/PARA (TT1) .1960 .0062 % .0035 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LUNG (LU) : LUNG (LU) : -ADHESION(S); BILATERAL CAUDAL LOBES TO PLEURA AND >NOT REQUIRED TO BE EXAMINED FOR ANIMAL DIAPHRAGM: MULTIPLE TAN, FIBROUS ADHESIONS; COLLECTED INTACT ADIPOSE TISSUE (AT) : ADIPOSE TISSUE (AT) : -RAISED FOCUS(I)/AREA(S); DIFFUSE, THROUGHOUT MESENTERY AND >NOT REQUIRED TO BE EXAMINED FOR ANIMAL THORACIC CAVITY: MULTIPLE, TAN, FIRM NODULES, UP TO 0.6 CM IN DIAMETER WITHIN MESENTERY (CAP 29), UP TO 0.3 CM IN DIAMETER WITHIN THORACIC CAVITY (CAP 30) AND COLLECTED INTACT WITH LUNG ADHESIONS GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS 849 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 22 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05510 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3180.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 9:48 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.6690 GRAMS BILE VOLUME IS 2.4000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), THYMUS (TH) ------------------------------------------------------------------------------------------------------------------------------------ 850 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 23 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05518 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3070.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 9:20 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2790 .0091 % .0044 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2460 .0080 % .0039 WEIGHT TAKEN BRAIN (BR) 62.8420 2.0470 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) .8790 .0286 % .0140 WEIGHT TAKEN RT EPIDIDYMIS (EP1) 1.0970 .0357 % .0175 WEIGHT TAKEN LF KIDNEY (KD0) 5.6790 .1850 % .0904 WEIGHT TAKEN RT KIDNEY (KD1) 5.6110 .1828 % .0893 WEIGHT TAKEN LIVER (LI) 57.5930 1.8760 % .9165 WEIGHT TAKEN LF TESTIS (TE0) 4.5720 .1489 % .0728 WEIGHT TAKEN RT TESTIS (TE1) 4.6220 .1506 % .0735 WEIGHT TAKEN PANCREAS (PA) 3.1580 .1029 % .0503 WEIGHT TAKEN LF THYROID/PARA (TT0) .2450 .0080 % .0039 WEIGHT TAKEN RT THYROID/PARA (TT1) .3110 .0101 % .0049 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- THYMUS (TH) : -ATROPHY,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5320 GRAMS BILE VOLUME IS 1.3000 ML -------------------------------------------- 851 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 24 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05518 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3070.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 9:20 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) ------------------------------------------------------------------------------------------------------------------------------------ 852 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 25 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05524 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3035.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:42 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2420 .0080 % .0038 WEIGHT TAKEN RIGHT ADRENAL (AD1) .1860 .0061 % .0029 WEIGHT TAKEN BRAIN (BR) 63.9330 2.1065 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) .9350 .0308 % .0146 WEIGHT TAKEN RT EPIDIDYMIS (EP1) .9840 .0324 % .0154 WEIGHT TAKEN LF KIDNEY (KD0) 5.0370 .1660 % .0788 WEIGHT TAKEN RT KIDNEY (KD1) 4.8440 .1596 % .0758 WEIGHT TAKEN LIVER (LI) 52.5550 1.7316 % .8220 WEIGHT TAKEN LF TESTIS (TE0) 4.6940 .1547 % .0734 WEIGHT TAKEN RT TESTIS (TE1) 4.2750 .1409 % .0669 WEIGHT TAKEN PANCREAS (PA) 4.6550 .1534 % .0728 WEIGHT TAKEN LF THYROID/PARA (TT0) .1210 .0040 % .0019 WEIGHT TAKEN RT THYROID/PARA (TT1) .1330 .0044 % .0021 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- THYMUS (TH) : -ATROPHY,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.9610 GRAMS BILE VOLUME IS 0.8000 ML -------------------------------------------- 853 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 26 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05524 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3035.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:42 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) ------------------------------------------------------------------------------------------------------------------------------------ 854 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05528 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3475.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 10:19 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3070 .0088 % .0044 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2620 .0075 % .0037 WEIGHT TAKEN BRAIN (BR) 69.8730 2.0107 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) .9990 .0287 % .0143 WEIGHT TAKEN RT EPIDIDYMIS (EP1) .9290 .0267 % .0133 WEIGHT TAKEN LF KIDNEY (KD0) 6.3390 .1824 % .0907 WEIGHT TAKEN RT KIDNEY (KD1) 6.3690 .1833 % .0912 WEIGHT TAKEN LIVER (LI) 64.9760 1.8698 % .9299 WEIGHT TAKEN LF TESTIS (TE0) 5.0300 .1447 % .0720 WEIGHT TAKEN RT TESTIS (TE1) 5.2350 .1506 % .0749 WEIGHT TAKEN PANCREAS (PA) 5.8230 .1676 % .0833 WEIGHT TAKEN LF THYROID/PARA (TT0) .2980 .0086 % .0043 WEIGHT TAKEN RT THYROID/PARA (TT1) .3900 .0112 % .0056 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR,-SLIGHT, DIFFUSE THYMUS (TH) : -ATROPHY,-SLIGHT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5220 GRAMS BILE VOLUME IS 1.8000 ML 855 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 28 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05528 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3475.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 10:19 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) ------------------------------------------------------------------------------------------------------------------------------------ 856 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 29 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05507 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3870.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 8:11 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .4540 .0117 % .0063 WEIGHT TAKEN RIGHT ADRENAL (AD1) .3210 .0083 % .0045 WEIGHT TAKEN BRAIN (BR) 71.7900 1.8550 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) 2.0740 .0536 % .0289 WEIGHT TAKEN RT EPIDIDYMIS (EP1) 2.3260 .0601 % .0324 WEIGHT TAKEN LF KIDNEY (KD0) 6.5150 .1683 % .0908 WEIGHT TAKEN RT KIDNEY (KD1) 6.2950 .1627 % .0877 WEIGHT TAKEN LIVER (LI) 112.4190 2.9049 % 1.5659 WEIGHT TAKEN LF TESTIS (TE0) 12.6370 .3265 % .1760 WEIGHT TAKEN RT TESTIS (TE1) 12.5000 .3230 % .1741 WEIGHT TAKEN PANCREAS (PA) 5.2280 .1351 % .0728 WEIGHT TAKEN LF THYROID/PARA (TT0) .2850 .0074 % .0040 WEIGHT TAKEN RT THYROID/PARA (TT1) .3460 .0089 % .0048 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-SLIGHT MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) : -INFILTRATE, LYMPHOHISTIOCYTIC, PERIVASCULAR,-MINIMAL -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-SLIGHT KIDNEY (KD) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -MINERALIZATION, CORTEX,-MINIMAL LIVER (LI) : LIVER (LI) : -MOTTLED; ALL LOBES: BROWN AND TAN -HYPERTROPHY, HEPATOCELLULAR,-MODERATE, DIFFUSE 857 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 30 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05507 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3870.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 8:11 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR,-MODERATELY SEVERE THYMUS (TH) : -CYST,-PRESENT -ATROPHY,-MODERATELY SEVERE LN, MESENTERIC (MS) : LN, MESENTERIC (MS) : -DIFFUSELY RED; DARK RED >UNREMARKABLE TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT ADRENAL, CORTEX (AC) : ADRENAL, CORTEX (AC) : -DIFFUSELY DARK; BILATERAL: DARK BROWN >UNREMARKABLE JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE PROSTATE (PR) : -INFLAMMATION, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5330 GRAMS BILE VOLUME IS 2.0000 ML -------------------------------------------- 858 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 31 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05507 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3870.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 8:11 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE) ------------------------------------------------------------------------------------------------------------------------------------ 859 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 32 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05512 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2285.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:21 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2790 .0122 % .0046 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2240 .0098 % .0037 WEIGHT TAKEN BRAIN (BR) 60.7370 2.6581 % 1.0000 WEIGHT TAKEN LF EPIDIDYMIS (EP0) .5450 .0239 % .0090 WEIGHT TAKEN RT EPIDIDYMIS (EP1) .4350 .0190 % .0072 WEIGHT TAKEN LF KIDNEY (KD0) 4.5470 .1990 % .0749 WEIGHT TAKEN RT KIDNEY (KD1) 4.5140 .1975 % .0743 WEIGHT TAKEN LIVER (LI) 58.1440 2.5446 % .9573 WEIGHT TAKEN LF TESTIS (TE0) 1.4310 .0626 % .0236 WEIGHT TAKEN RT TESTIS (TE1) 1.3310 .0582 % .0219 WEIGHT TAKEN PANCREAS (PA) 3.0430 .1332 % .0501 WEIGHT TAKEN LF THYROID/PARA (TT0) .1190 .0052 % .0020 WEIGHT TAKEN RT THYROID/PARA (TT1) .1260 .0055 % .0021 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATE MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL LIVER (LI) : LIVER (LI) : -MOTTLED; ALL LOBES: BROWN AND TAN -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT GALLBLADDER (GB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT THYMUS (TH) : -ATROPHY,-MODERATELY SEVERE 860 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 33 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05512 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2285.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:21 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LN, MESENTERIC (MS) : -HEMORRHAGE,-MINIMAL TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT -INFLAMMATION, ACUTE,-MINIMAL ADRENAL, CORTEX (AC) : ADRENAL, CORTEX (AC) : -DIFFUSELY DARK; BILATERAL: BROWN >UNREMARKABLE SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT MAMMARY, MALE (MM) : >SECTION EXAMINED; TISSUE NOT PRESENT PROSTATE (PR) : -INFLAMMATION, LYMPHOHISTIOCYTIC,-MINIMAL EPIDIDYMIDES (EP) : -HYPOSPERMIA,-SEVERE TESTIS (TE) : -IMMATURE,-PRESENT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.3100 GRAMS BILE VOLUME IS 1.2000 ML -------------------------------------------- 861 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 34 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05512 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2285.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:21 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), KIDNEY (KD), LUNG (LU), HEART (HT), SPLEEN (SP), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV) ------------------------------------------------------------------------------------------------------------------------------------ 862 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 35 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05530 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2755.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 11:29 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2480 .0090 % .0041 WEIGHT TAKEN RIGHT ADRENAL (AD1) .1640 .0060 % .0027 WEIGHT TAKEN BRAIN (BR) 60.5500 2.1978 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 5.6520 .2052 % .0933 WEIGHT TAKEN RT KIDNEY (KD1) 5.4770 .1988 % .0905 WEIGHT TAKEN LIVER (LI) 49.1800 1.7851 % .8122 WEIGHT TAKEN LF OVARY (OV0) .1220 .0044 % .0020 WEIGHT TAKEN RT OVARY (OV1) .1280 .0046 % .0021 WEIGHT TAKEN PANCREAS (PA) 4.2470 .1542 % .0701 WEIGHT TAKEN LF THYROID/PARA (TT0) .2100 .0076 % .0035 WEIGHT TAKEN RT THYROID/PARA (TT1) .2150 .0078 % .0036 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MINIMAL BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MODERATE KIDNEY (KD) : -GLOMERULOSCLEROSIS,-MINIMAL LUNG (LU) : LUNG (LU) : -ADHESION(S); ALL LOBES TO EACH OTHER, PLEURA, PERICARDIAL -HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,- SAC, AND CAUDAL LOBES TO DIAPHRAGM: MULTIPLE RED, TAN, MINIMAL FIBROUS ADHESIONS; COLLECTED INTACT -FIBROSIS, PLEURAL/SUBPLEURAL,-SLIGHT LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 863 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 36 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05530 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2755.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 11:29 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- THYROID (TY) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL MUSCLE, SKELETAL (SM) : -DEGENERATION,-SLIGHT -INFLAMMATION, GRANULOMATOUS,-MODERATE -REGENERATION, MYOFIBER,-MODERATELY SEVERE URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5970 GRAMS BILE VOLUME IS 1.2000 ML -------------------------------------------- 864 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05530 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2755.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 11:29 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), ESOPHAGUS (ES), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV) ------------------------------------------------------------------------------------------------------------------------------------ 865 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 38 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05531 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2625.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:15 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2360 .0090 % .0043 WEIGHT TAKEN RIGHT ADRENAL (AD1) .1480 .0056 % .0027 WEIGHT TAKEN BRAIN (BR) 54.3050 2.0688 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 4.3520 .1658 % .0801 WEIGHT TAKEN RT KIDNEY (KD1) 4.2910 .1635 % .0790 WEIGHT TAKEN LIVER (LI) 42.1310 1.6050 % .7758 WEIGHT TAKEN LF OVARY (OV0) .0990 .0038 % .0018 WEIGHT TAKEN RT OVARY (OV1) .0930 .0035 % .0017 WEIGHT TAKEN PANCREAS (PA) 3.9080 .1489 % .0720 WEIGHT TAKEN LF THYROID/PARA (TT0) .1970 .0075 % .0036 WEIGHT TAKEN RT THYROID/PARA (TT1) .1740 .0066 % .0032 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-SLIGHT KIDNEY (KD) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL ADRENAL, CORTEX (AC) : -HYPERTROPHY, CORTICAL CELL,-MINIMAL SPINAL CORD (SC) : -PIGMENT, NEURONAL,-SLIGHT JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE 866 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 39 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05531 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2625.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:15 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MINIMAL UTERUS (UT) : -AMYLOID,-SLIGHT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.7250 GRAMS BILE VOLUME IS 1.8000 ML -------------------------------------------- 867 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 40 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05531 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2625.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:15 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), OVARY (OV), VAGINA (VA), CERVIX (CV) ------------------------------------------------------------------------------------------------------------------------------------ 868 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 41 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05535 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3270.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 8:13 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3770 .0115 % .0073 WEIGHT TAKEN RIGHT ADRENAL (AD1) .3150 .0096 % .0061 WEIGHT TAKEN BRAIN (BR) 51.9670 1.5892 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 6.6940 .2047 % .1288 WEIGHT TAKEN RT KIDNEY (KD1) 6.1830 .1891 % .1190 WEIGHT TAKEN LIVER (LI) 64.3990 1.9694 % 1.2392 WEIGHT TAKEN LF OVARY (OV0) .2280 .0070 % .0044 WEIGHT TAKEN RT OVARY (OV1) .2100 .0064 % .0040 WEIGHT TAKEN PANCREAS (PA) 5.0450 .1543 % .0971 WEIGHT TAKEN LF THYROID/PARA (TT0) .4660 .0143 % .0090 WEIGHT TAKEN RT THYROID/PARA (TT1) .4370 .0134 % .0084 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT LUNG (LU) : LUNG (LU) : -ADHESION(S); ALL LOBES TO EACH OTHER, PLEURA, AND -FIBROSIS, PLEURAL/SUBPLEURAL,-SEVERE PERICARDIAL SAC: MULTIPLE RED, TAN, FIBROUS ADHESIONS; -FIBROSIS, INTERSTITIAL,-MODERATELY SEVERE COLLECTED INTACT LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -VACUOLATION, HEPATOCELLULAR,-MINIMAL, MULTI-FOCAL SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT STOMACH, GL (ST) : STOMACH, GL (ST) : -RED FOCUS(I)/AREA(S); MUCOSA, FUNDIC: SINGLE RED FOCUS, 0.3 >UNREMARKABLE MM IN DIAMETER; FOCUS HAS A STELLATE PATTERN 869 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 42 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05535 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3270.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 8:13 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- STOMACH, GL (ST) : >NOTE:>FUNDIC MUCOSA, ALONG GREATER CURVATURE: SINGLE APPARENT HOOK WORM EMBEDDED INTO MUCOSA, 3.0 X 0.1 X 0.1 CM DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE CECUM (CE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT MAMMARY, FEMALE (MF) : -INFLAMMATION, ACUTE,-MINIMAL URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL UTERUS (UT) : -AMYLOID,-SLIGHT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>ANIMAL APPEARS TO BE IN ESTROUS GALLBLADDER WEIGHT IS 0.6970 GRAMS BILE VOLUME IS 2.6000 ML -------------------------------------------- 870 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 43 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05535 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3270.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 8:13 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), PANCREAS (PA), COLON (CO), RECTUM (RE), SKIN (SK), OVARY (OV), VAGINA (VA), CERVIX (CV) ------------------------------------------------------------------------------------------------------------------------------------ 871 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 44 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05544 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2635.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:55 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3120 .0118 % .0052 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2440 .0093 % .0041 WEIGHT TAKEN BRAIN (BR) 59.7410 2.2672 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 5.3110 .2016 % .0889 WEIGHT TAKEN RT KIDNEY (KD1) 5.2470 .1991 % .0878 WEIGHT TAKEN LIVER (LI) 48.6600 1.8467 % .8145 WEIGHT TAKEN LF OVARY (OV0) .2260 .0086 % .0038 WEIGHT TAKEN RT OVARY (OV1) .1380 .0052 % .0023 WEIGHT TAKEN PANCREAS (PA) 4.5080 .1711 % .0755 WEIGHT TAKEN LF THYROID/PARA (TT0) .1540 .0058 % .0026 WEIGHT TAKEN RT THYROID/PARA (TT1) .1560 .0059 % .0026 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- MARROW, STERNUM (SE) : -HYPOCELLULAR, MARROW,-SLIGHT BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MODERATE LIVER (LI) : LIVER (LI) : -LIGHT FOCUS(I)/AREA(S); TRIM COMMENT: DIAPHRAGMATIC SURFACE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL OF LEFT LATERAL LOBE: SINGLE TAN AREA, 1.0 CM IN DIAMETER; SUBMITTED ON ROUTINE SECTION GALLBLADDER (GB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL LN, MESENTERIC (MS) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 872 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 45 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05544 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2635.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:55 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- ESOPHAGUS (ES) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PARATHYROID (PT) : >SECTION EXAMINED; TISSUE NOT PRESENT MUSCLE, SKELETAL (SM) : -PARASITES, CYST,-PRESENT >NOTE:>HEAVY BURDEN, SARCOCYST-LIKE. DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT MAMMARY, FEMALE (MF) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT OVARY (OV) : -MINERALIZATION,-MODERATE GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.3810 GRAMS BILE VOLUME IS 2.2000 ML -------------------------------------------- 873 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 46 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05544 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2635.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:55 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), BONE, STERNUM (SB), EYE (EY), KIDNEY (KD), LUNG (LU), HEART (HT), SPLEEN (SP), THYMUS (TH), THYROID (TY), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), PANCREAS (PA), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), UTERUS (UT), VAGINA (VA), CERVIX (CV) ------------------------------------------------------------------------------------------------------------------------------------ 874 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 47 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05537 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 4055.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 7:31 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3730 .0092 % .0061 WEIGHT TAKEN RIGHT ADRENAL (AD1) .3030 .0075 % .0049 WEIGHT TAKEN BRAIN (BR) 61.3750 1.5136 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 7.0240 .1732 % .1144 WEIGHT TAKEN RT KIDNEY (KD1) 6.6650 .1644 % .1086 WEIGHT TAKEN LIVER (LI) 75.2140 1.8548 % 1.2255 WEIGHT TAKEN LF OVARY (OV0) .2790 .0069 % .0045 WEIGHT TAKEN RT OVARY (OV1) .2280 .0056 % .0037 WEIGHT TAKEN PANCREAS (PA) 6.1370 .1513 % .1000 WEIGHT TAKEN LF THYROID/PARA (TT0) .3200 .0079 % .0052 WEIGHT TAKEN RT THYROID/PARA (TT1) .3400 .0084 % .0055 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL THYMUS (TH) : -ATROPHY,-MINIMAL SPINAL CORD (SC) : -PIGMENT, NEURONAL,-SLIGHT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -ANIMAL OBESE GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5100 GRAMS BILE VOLUME IS 3.0000 ML -------------------------------------------- 875 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 48 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05537 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 4055.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 7:31 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) ------------------------------------------------------------------------------------------------------------------------------------ 876 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 49 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05541 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2510.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 9:47 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .4170 .0166 % .0066 WEIGHT TAKEN RIGHT ADRENAL (AD1) .3060 .0122 % .0048 WEIGHT TAKEN BRAIN (BR) 63.2760 2.5210 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 4.9450 .1970 % .0781 WEIGHT TAKEN RT KIDNEY (KD1) 4.6880 .1868 % .0741 WEIGHT TAKEN LIVER (LI) 47.6610 1.8988 % .7532 WEIGHT TAKEN LF OVARY (OV0) .1240 .0049 % .0020 WEIGHT TAKEN RT OVARY (OV1) .1570 .0063 % .0025 WEIGHT TAKEN PANCREAS (PA) 5.0750 .2022 % .0802 WEIGHT TAKEN LF THYROID/PARA (TT0) .2130 .0085 % .0034 WEIGHT TAKEN RT THYROID/PARA (TT1) .2300 .0092 % .0036 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LUNG (LU) : LUNG (LU) : -ADHESION(S); RIGHT AND LEFT CAUDAL LOBES AND LEFT >NOT REQUIRED TO BE EXAMINED FOR ANIMAL INTERMEDIATE LOBE TO DIAPHRAGM: MULTIPLE TAN, FIBROUS ADHESIONS; COLLECTED INTACT -DARK FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK BROWN AREAS, PINPOINT AND UP TO 0.7 X 0.4 CM LIVER (LI) : LIVER (LI) : -ADHESION(S); DIAPHRAGMATIC SURFACE OF RIGHT LATERAL LOBE TO -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL SURROUNDING MESENTERY, ALONG MARGIN: MULTIPLE TAN, FIBROUS ADHESIONS (CAP 29) THYMUS (TH) : -ATROPHY,-MODERATE SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MODERATE 877 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 50 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05541 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2510.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 9:47 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5260 GRAMS BILE VOLUME IS 1.0000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) ------------------------------------------------------------------------------------------------------------------------------------ 878 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 51 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05547 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2570.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 9:20 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3130 .0122 % .0051 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2300 .0089 % .0038 WEIGHT TAKEN BRAIN (BR) 60.8690 2.3684 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 5.4180 .2108 % .0890 WEIGHT TAKEN RT KIDNEY (KD1) 5.5840 .2173 % .0917 WEIGHT TAKEN LIVER (LI) 49.9520 1.9437 % .8206 WEIGHT TAKEN LF OVARY (OV0) .1590 .0062 % .0026 WEIGHT TAKEN RT OVARY (OV1) .2030 .0079 % .0033 WEIGHT TAKEN PANCREAS (PA) 5.1480 .2003 % .0846 WEIGHT TAKEN LF THYROID/PARA (TT0) .1550 .0060 % .0025 WEIGHT TAKEN RT THYROID/PARA (TT1) .1410 .0055 % .0023 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LUNG (LU) : LUNG (LU) : -ADHESION(S); LEFT CAUDAL LOBE TO DIAPHRAGM: MULTIPLE TAN, >NOT REQUIRED TO BE EXAMINED FOR ANIMAL FIBROUS ADHESIONS; COLLECTED INTACT -DARK FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK BROWN AREAS, PINPOINT AND UP TO 0.5 X 0.3 CM LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL THYMUS (TH) : -CYST,-PRESENT -ATROPHY,-SLIGHT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS 879 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 52 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05547 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2570.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 9:20 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5380 GRAMS BILE VOLUME IS 1.2000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: SPINAL CORD (SC) ------------------------------------------------------------------------------------------------------------------------------------ 880 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 53 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05550 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2820.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 6:43 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .4230 .0150 % .0074 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2680 .0095 % .0047 WEIGHT TAKEN BRAIN (BR) 56.9130 2.0182 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 6.0900 .2160 % .1070 WEIGHT TAKEN RT KIDNEY (KD1) 6.1500 .2181 % .1081 WEIGHT TAKEN LIVER (LI) 54.4840 1.9321 % .9573 WEIGHT TAKEN LF OVARY (OV0) .1270 .0045 % .0022 WEIGHT TAKEN RT OVARY (OV1) .1270 .0045 % .0022 WEIGHT TAKEN PANCREAS (PA) 7.2830 .2583 % .1280 WEIGHT TAKEN LF THYROID/PARA (TT0) .1670 .0059 % .0029 WEIGHT TAKEN RT THYROID/PARA (TT1) .2290 .0081 % .0040 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LUNG (LU) : LUNG (LU) : -ADHESION(S); ALL LOBES TO EACH OTHER, PLEURA, PERICARDIAL >NOT REQUIRED TO BE EXAMINED FOR ANIMAL SAC, CAUDAL LOBES TO DIAPHRAGM: MULTIPLE RED, TAN, FIBROUS ADHESIONS; COLLECTED INTACT LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -VACUOLATION, HEPATOCELLULAR,-SLIGHT, MULTI-FOCAL THYMUS (TH) : -ATROPHY,-MINIMAL SPINAL CORD (SC) : -PIGMENT, NEURONAL,-SLIGHT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS 881 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 54 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05550 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2820.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 6:43 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.6200 GRAMS BILE VOLUME IS 1.2000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) ------------------------------------------------------------------------------------------------------------------------------------ 882 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 55 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05532 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2550.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 6:47 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3230 .0127 % .0054 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2160 .0085 % .0036 WEIGHT TAKEN BRAIN (BR) 60.2360 2.3622 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 5.0310 .1973 % .0835 WEIGHT TAKEN RT KIDNEY (KD1) 4.9920 .1958 % .0829 WEIGHT TAKEN LIVER (LI) 58.3190 2.2870 % .9682 WEIGHT TAKEN LF OVARY (OV0) .0630 .0025 % .0010 WEIGHT TAKEN RT OVARY (OV1) .0870 .0034 % .0014 WEIGHT TAKEN PANCREAS (PA) 4.5080 .1768 % .0748 WEIGHT TAKEN LF THYROID/PARA (TT0) .1150 .0045 % .0019 WEIGHT TAKEN RT THYROID/PARA (TT1) .1020 .0040 % .0017 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LUNG (LU) : LUNG (LU) : -RED FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK RED PINPOINT >NOT REQUIRED TO BE EXAMINED FOR ANIMAL FOCI THYMUS (TH) : -ATROPHY,-SEVERE SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MODERATE GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.4650 GRAMS BILE VOLUME IS 1.2000 ML -------------------------------------------- 883 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 56 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05532 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2550.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 6:47 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) ------------------------------------------------------------------------------------------------------------------------------------ 884 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 57 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05538 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3200.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 10:25 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3850 .0120 % .0069 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2630 .0082 % .0047 WEIGHT TAKEN BRAIN (BR) 55.6900 1.7403 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 5.8390 .1825 % .1048 WEIGHT TAKEN RT KIDNEY (KD1) 5.3480 .1671 % .0960 WEIGHT TAKEN LIVER (LI) 59.5780 1.8618 % 1.0698 WEIGHT TAKEN LF OVARY (OV0) .2420 .0076 % .0043 WEIGHT TAKEN RT OVARY (OV1) .1690 .0053 % .0030 WEIGHT TAKEN PANCREAS (PA) 4.8070 .1502 % .0863 WEIGHT TAKEN LF THYROID/PARA (TT0) .1350 .0042 % .0024 WEIGHT TAKEN RT THYROID/PARA (TT1) .1480 .0046 % .0027 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LUNG (LU) : LUNG (LU) : -DARK FOCUS(I)/AREA(S); ALL LOBES, DIFFUSE: MULTIPLE BLACK >NOT REQUIRED TO BE EXAMINED FOR ANIMAL PINPOINT FOCI LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL SPLEEN (SP) : SPLEEN (SP) : -LIGHT FOCUS(I)/AREA(S); DIFFUSE: MULTIPLE GRAY AREAS, UP TO >NOT REQUIRED TO BE EXAMINED FOR ANIMAL 1.2 X 0.7 CM THYMUS (TH) : -ATROPHY,-SLIGHT SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MINIMAL CECUM (CE) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL 885 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 58 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05538 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3200.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 10:25 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- CECUM (CE) : -RED FOCUS(I)/AREA(S); SEROSAL SURFACE: MULTIPLE DARK RED FOCI, UP TO 0.5 CM IN DIAMETER; COLLECTED ON ROUTINE SECTION GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5060 GRAMS BILE VOLUME IS 1.6000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) ------------------------------------------------------------------------------------------------------------------------------------ 886 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 59 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05545 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2460.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 7:31 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .2640 .0107 % .0047 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2060 .0084 % .0037 WEIGHT TAKEN BRAIN (BR) 55.6590 2.2626 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 5.4870 .2230 % .0986 WEIGHT TAKEN RT KIDNEY (KD1) 5.2040 .2115 % .0935 WEIGHT TAKEN LIVER (LI) 52.4930 2.1339 % .9431 WEIGHT TAKEN LF OVARY (OV0) .2040 .0083 % .0037 WEIGHT TAKEN RT OVARY (OV1) .1400 .0057 % .0025 WEIGHT TAKEN PANCREAS (PA) 4.1150 .1673 % .0739 WEIGHT TAKEN LF THYROID/PARA (TT0) .2030 .0083 % .0036 WEIGHT TAKEN RT THYROID/PARA (TT1) .1190 .0048 % .0021 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -DEGENERATION/NECROSIS, HEPATOCELLULAR,-MINIMAL, MULTI-FOCAL THYMUS (TH) : -CYST,-PRESENT -ATROPHY,-MINIMAL SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS 887 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 60 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05545 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2460.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 7:31 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.7210 GRAMS BILE VOLUME IS 1.4000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) ------------------------------------------------------------------------------------------------------------------------------------ 888 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 61 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05548 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2865.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 11:00 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3880 .0135 % .0063 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2850 .0099 % .0046 WEIGHT TAKEN BRAIN (BR) 61.9790 2.1633 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 6.0250 .2103 % .0972 WEIGHT TAKEN RT KIDNEY (KD1) 6.0670 .2118 % .0979 WEIGHT TAKEN LIVER (LI) 57.7670 2.0163 % .9320 WEIGHT TAKEN LF OVARY (OV0) .2400 .0084 % .0039 WEIGHT TAKEN RT OVARY (OV1) .1510 .0053 % .0024 WEIGHT TAKEN PANCREAS (PA) 5.0690 .1769 % .0818 WEIGHT TAKEN LF THYROID/PARA (TT0) .1640 .0057 % .0026 WEIGHT TAKEN RT THYROID/PARA (TT1) .1640 .0057 % .0026 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LUNG (LU) : LUNG (LU) : -ADHESION(S); ADHERED TO PLEURA, DIAPHRAGM, PERICARDIUM, AND >NOT REQUIRED TO BE EXAMINED FOR ANIMAL EACH OTHER: MULTIPLE GRAY, FIBROUS ADHESIONS; COLLECTED INTACT LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MODERATE, FOCAL THYMUS (TH) : -ATROPHY,-MODERATELY SEVERE SPINAL CORD (SC) : -PIGMENT, NEURONAL,-SLIGHT CECUM (CE) : CECUM (CE) : -RED FOCUS(I)/AREA(S); DIFFUSE: MULTIPLE DARK RED FOCI, UP >NOT REQUIRED TO BE EXAMINED FOR ANIMAL TO 0.5 CM IN DIAMETER; COLLECTED ON ROUTINE SECTION 889 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05548 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2865.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 11:00 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.7810 GRAMS BILE VOLUME IS 2.6000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) ------------------------------------------------------------------------------------------------------------------------------------ 890 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 63 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05534 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2500.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 8:14 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3290 .0132 % .0061 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2270 .0091 % .0042 WEIGHT TAKEN BRAIN (BR) 54.3510 2.1740 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 4.8280 .1931 % .0888 WEIGHT TAKEN RT KIDNEY (KD1) 4.9920 .1997 % .0918 WEIGHT TAKEN LIVER (LI) 75.5500 3.0220 % 1.3900 WEIGHT TAKEN LF OVARY (OV0) .1600 .0064 % .0029 WEIGHT TAKEN RT OVARY (OV1) .1480 .0059 % .0027 WEIGHT TAKEN PANCREAS (PA) 4.4740 .1790 % .0823 WEIGHT TAKEN LF THYROID/PARA (TT0) .1370 .0055 % .0025 WEIGHT TAKEN RT THYROID/PARA (TT1) .1210 .0048 % .0022 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATE KIDNEY (KD) : -MINERALIZATION, MEDULLA,-MINIMAL LUNG (LU) : LUNG (LU) : -DARK FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK BROWN -HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,- PINPOINT FOCI MINIMAL -LIGHT FOCUS(I)/AREA(S); RIGHT AND LEFT CAUDAL LOBES: -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL MULTIPLE TAN AREAS, UP TO 0.2 X 0.1 CM LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR,-SLIGHT, DIFFUSE -VACUOLATION, HEPATOCELLULAR,-SLIGHT, DIFFUSE 891 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 64 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05534 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2500.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 8:14 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- THYMUS (TH) : -ATROPHY,-MODERATE TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT ADRENAL, CORTEX (AC) : ADRENAL, CORTEX (AC) : -DIFFUSELY DARK; BILATERAL: BROWN >UNREMARKABLE DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT CECUM (CE) : CECUM (CE) : -DARK FOCUS(I)/AREA(S); SEROSAL SURFACE AND LUMEN, DIFFUSE: -PARASITISM,-PRESENT MULTIPLE DARK BROWN, SLIGHTLY RAISED AREAS, UP TO 0.5 X 0.2 CM; COLLECTED ON ROUTINE SECTION COLON (CO) : COLON (CO) : -DARK FOCUS(I)/AREA(S); SEROSAL SURFACE AND LUMEN, DIFFUSE: -PARASITISM, INTRAMUSCULAR,-PRESENT MULTIPLE DARK BROWN, SLIGHTLY RAISED FOCI, UP TO 0.3 CM IN DIAMETER; COLLECTED ON ROUTINE SECTION URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL OVARY (OV) : -MINERALIZATION,-MINIMAL ADIPOSE TISSUE (AT) : ADIPOSE TISSUE (AT) : -RAISED FOCUS(I)/AREA(S); MESENTERY, DIFFUSE: MULTIPLE TAN -LYMPHOID TISSUE,-PRESENT FOCI, UP TO 0.3 CM IN DIAMETER (CAP 29) GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN 892 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 65 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05534 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2500.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 8:14 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL COMMENT (GC) : -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5260 GRAMS BILE VOLUME IS 2.0000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), LN, MESENTERIC (MS), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), PANCREAS (PA), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), UTERUS (UT), VAGINA (VA), CERVIX (CV) ------------------------------------------------------------------------------------------------------------------------------------ 893 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 66 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05536 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3185.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:56 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3290 .0103 % .0056 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2360 .0074 % .0040 WEIGHT TAKEN BRAIN (BR) 58.3990 1.8336 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 6.9900 .2195 % .1197 WEIGHT TAKEN RT KIDNEY (KD1) 7.4110 .2327 % .1269 WEIGHT TAKEN LIVER (LI) 93.8600 2.9469 % 1.6072 WEIGHT TAKEN LF OVARY (OV0) .1010 .0032 % .0017 WEIGHT TAKEN RT OVARY (OV1) .1360 .0043 % .0023 WEIGHT TAKEN PANCREAS (PA) 4.7900 .1504 % .0820 WEIGHT TAKEN LF THYROID/PARA (TT0) .1910 .0060 % .0033 WEIGHT TAKEN RT THYROID/PARA (TT1) .2400 .0075 % .0041 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL LUNG (LU) : LUNG (LU) : -DARK FOCUS(I)/AREA(S); ALL LOBES, DIFFUSE: MULTIPLE >UNREMARKABLE PINPOINT BLACK FOCI LIVER (LI) : LIVER (LI) : -MOTTLED; ALL LOBES: BROWN AND TAN -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR,-MODERATELY SEVERE GALLBLADDER (GB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 894 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 67 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05536 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3185.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:56 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- THYMUS (TH) : -CYST,-PRESENT -ATROPHY,-MODERATELY SEVERE TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT ADRENAL, CORTEX (AC) : ADRENAL, CORTEX (AC) : -DIFFUSELY DARK; BILATERAL: BROWN -HYPERTROPHY, CORTICAL CELL,-MINIMAL -PIGMENT,-SLIGHT SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MODERATE DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT CECUM (CE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT UTERUS (UT) : -AMYLOID,-MODERATE OVARY (OV) : -AMYLOID,-MODERATE -ONE EXAMINED,-PRESENT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN 895 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 68 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05536 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/25/99 STUDY DAY OF DEATH: 184 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 3185.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/99 9:56 PROSECTOR: STEVE VAN ADESTINE RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: TODD ACKER ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- GENERAL COMMENT (GC) : -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.6650 GRAMS BILE VOLUME IS 2.6000 ML -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), KIDNEY (KD), HEART (HT), SPLEEN (SP), LN, MESENTERIC (MS), ESOPHAGUS (ES), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), PANCREAS (PA), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), VAGINA (VA), CERVIX (CV) ------------------------------------------------------------------------------------------------------------------------------------ 896 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 69 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05540 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2700.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 10:20 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3440 .0127 % .0061 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2550 .0094 % .0045 WEIGHT TAKEN BRAIN (BR) 56.3190 2.0859 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 5.2090 .1929 % .0925 WEIGHT TAKEN RT KIDNEY (KD1) 4.8440 .1794 % .0860 WEIGHT TAKEN LIVER (LI) 63.0760 2.3361 % 1.1200 WEIGHT TAKEN LF OVARY (OV0) .1400 .0052 % .0025 WEIGHT TAKEN RT OVARY (OV1) .1410 .0052 % .0025 WEIGHT TAKEN PANCREAS (PA) 4.4510 .1649 % .0790 WEIGHT TAKEN LF THYROID/PARA (TT0) .2480 .0092 % .0044 WEIGHT TAKEN RT THYROID/PARA (TT1) .2540 .0094 % .0045 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-SLIGHT LUNG (LU) : LUNG (LU) : -RED FOCUS(I)/AREA(S); RIGHT CAUDAL AND APICAL LOBES: -HEMORRHAGE,-MODERATE MULTIPLE DARK RED INDISTINCT AREAS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT THYMUS (TH) : -CYST,-PRESENT -ATROPHY,-SLIGHT 897 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 70 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05540 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2700.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 10:20 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT AORTA (AO) : -PROLIFERATION, INTIMAL,-MODERATE MUSCLE, SKELETAL (SM) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT SKIN (SK) : SKIN (SK) : -ALOPECIA-FOCAL; RIGHT DORSAL THORACIC REGION: 0.3 X 2.5 CM -HAIR FOLLICLES, DECREASED,-MODERATE (CAP 29) GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5650 GRAMS BILE VOLUME IS 1.6000 ML -------------------------------------------- 898 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 71 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05540 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2700.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 10:20 PROSECTOR: STEVE VAN ADESTINE RECORDER: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: JOHN S. HALFORD ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), KIDNEY (KD), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), LN, MESENTERIC (MS), ESOPHAGUS (ES), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), PITUITARY (PI), SALIV GL, MANDIB (SG), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV) ------------------------------------------------------------------------------------------------------------------------------------ 899 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 72 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05551 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2230.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:43 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN ORGAN NAME (GRAMS) TO BODY WEIGHT (%) WEIGHT RATIO STATUS ---------------------- -------- -------- -------- ----------- LEFT ADRENAL (AD0) .3850 .0173 % .0065 WEIGHT TAKEN RIGHT ADRENAL (AD1) .2960 .0133 % .0050 WEIGHT TAKEN BRAIN (BR) 59.3140 2.6598 % 1.0000 WEIGHT TAKEN LF KIDNEY (KD0) 6.0280 .2703 % .1016 WEIGHT TAKEN RT KIDNEY (KD1) 5.9040 .2648 % .0995 WEIGHT TAKEN LIVER (LI) 68.7130 3.0813 % 1.1585 WEIGHT TAKEN LF OVARY (OV0) .2350 .0105 % .0040 WEIGHT TAKEN RT OVARY (OV1) .1740 .0078 % .0029 WEIGHT TAKEN PANCREAS (PA) 3.7750 .1693 % .0636 WEIGHT TAKEN LF THYROID/PARA (TT0) .1730 .0078 % .0029 WEIGHT TAKEN RT THYROID/PARA (TT1) .1630 .0073 % .0027 WEIGHT TAKEN ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) : -INFLAMMATION, LYMPHOHISTIOCYTIC,-MINIMAL KIDNEY (KD) : -MINERALIZATION, MEDULLA,-MINIMAL LUNG (LU) : LUNG (LU) : -RED FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK RED FOCI, >UNREMARKABLE PINPOINT AND UP TO 1 MM IN DIAMETER LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT GALLBLADDER (GB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 900 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 73 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05551 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2230.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:43 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ O B S E R V A T I O N S (CONTINUED) NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYROID (TY) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL MUSCLE, SKELETAL (SM) : -PARASITES, CYST,-PRESENT SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MODERATE JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT SKIN (SK) : SKIN (SK) : -ALOPECIA-DIFFUSE; ALL FOUR LIMBS: HAIRCOAT THIN; COLLECTED -HAIR FOLLICLES, DECREASED,-SLIGHT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS GENERAL INFORMATION (XX) : >NOTE:>ANIMAL APPEARS TO BE IN ESTROUS GALLBLADDER WEIGHT IS 0.6040 GRAMS BILE VOLUME IS 1.8000 ML -------------------------------------------- 901 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Terminal Sacrifice PAGE: 74 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05551 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 02/26/99 STUDY DAY OF DEATH: 185 STUDY WEEK OF DEATH: 27 TERMINAL BODY WEIGHT: 2230.0 GRAMS DATE AND TIME OF NECROPSY: 02/26/99 7:43 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ROBERT LEEDLE WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), HEART (HT), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), ESOPHAGUS (ES), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV) ------------------------------------------------------------------------------------------------------------------------------------ 902 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Recovery Sacrifice PAGE: 1 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05511 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST POST-RECOV SAC DATE OF DEATH: 02/25/00 STUDY DAY OF DEATH: 549 STUDY WEEK OF DEATH: 79 TERMINAL BODY WEIGHT: 4240.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/00 7:56 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: AS ASSIGNED WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ *** ORGAN WEIGHTS WERE NOT RECORDED *** ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: LIVER (LI), BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), CAVITY, THORACIC (TA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER, BIOPSY (LI0) ------------------------------------------------------------------------------------------------------------------------------------ 903 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Recovery Sacrifice PAGE: 2 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05522 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST POST-RECOV SAC DATE OF DEATH: 02/25/00 STUDY DAY OF DEATH: 549 STUDY WEEK OF DEATH: 79 TERMINAL BODY WEIGHT: 4350.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/00 8:35 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: AS ASSIGNED WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ *** ORGAN WEIGHTS WERE NOT RECORDED *** ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER, BIOPSY (LI0) : -PIGMENT, HEPATOCELLULAR,-SLIGHT LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MODERATE -PIGMENT, HEPATOCELLULAR,-SLIGHT -HYPERPLASIA, BILE DUCT,-MODERATE -INFLAMMATION, EOSINOPHILIC, PERI-BILE DUCT,-MODERATE LUNG (LU) : LUNG (LU) : -ADHESION(S); ALL LOBES TO EACH OTHER, PLEURA, PERICARDIAL >NOT REQUIRED TO BE EXAMINED FOR ANIMAL SAC AND CAUDAL LOBES TO DIAPHRAGM: MULTIPLE TAN FIBROUS ADHESIONS CAVITY, THORACIC (TA) : -NODULE(S); WITHIN ADHESIONS: MULTIPLE TAN AND FIRM NODULES, UP TO 0.3 CM IN DIAMETER -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: LIVER (LI), BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------------------------ 904 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Recovery Sacrifice PAGE: 3 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05533 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST POST-RECOV SAC DATE OF DEATH: 02/25/00 STUDY DAY OF DEATH: 549 STUDY WEEK OF DEATH: 79 TERMINAL BODY WEIGHT: 2535.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/00 8:58 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: AS ASSIGNED WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ *** ORGAN WEIGHTS WERE NOT RECORDED *** ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : LIVER (LI) : -ADHESION(S); DIAPHRAGMATIC SURFACE OF RIGHT MEDIAN LOBE TO -FIBROSIS, CAPSULAR,-SLIGHT DIAPHRAGM: SINGLE TAN, FIBROUS LINEAR AREA, 2.0 CM IN LENGTH GALLBLADDER (GB) : GALLBLADDER (GB) : >NOTE:>NO BILE AVAILABLE FOR SPECIAL PROCEDURE >NOT REQUIRED TO BE EXAMINED FOR ANIMAL -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), GENERAL COMMENT (GC), CAVITY, THORACIC (TA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER, BIOPSY (LI0) ------------------------------------------------------------------------------------------------------------------------------------ 905 APPENDIX 5 Individual Anatomic Pathology Data Covance 6329-223 3M T-6295.7 Recovery Sacrifice PAGE: 4 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ------------------------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: I05542 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST POST-RECOV SAC DATE OF DEATH: 02/25/00 STUDY DAY OF DEATH: 549 STUDY WEEK OF DEATH: 79 TERMINAL BODY WEIGHT: 3705.0 GRAMS DATE AND TIME OF NECROPSY: 02/25/00 9:23 PROSECTOR: KEVIN BILLINGS RECORDER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: AS ASSIGNED WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------------------------ *** ORGAN WEIGHTS WERE NOT RECORDED *** ------------------------------------------------------------------------------------------------------------------------------------ OBSERVATIONS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: LIVER (LI), BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), CAVITY, THORACIC (TA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER, BIOPSY (LI0) ------------------------------------------------------------------------------------------------------------------------------------ 906 Covance 6329-223 3M T-6295.7 APPENDIX 6 AniLytics Inc. Quality Assurance Statements Summary and Individual Blood Hormone Determination Note: This appendix contains information supplied and audited by AniLytics Inc. 907 Covance 6329-223 3M T-6295.7 908 Covance 6329-223 3M T-6295.7 909 Covance 6329-223 3M T-6295.7 910 Covance 6329-223 3M T-6295.7 911 Covance 6329-223 3M T-6295.7 912 Covance 6329-223 3M T-6295.7 913 Covance 6329-223 3M T-6295.7 914 Covance 6329-223 3M T-6295.7 915 Covance 6329-223 3M T-6295.7 916 Appendix 6 Summary and Individual Blood Hormone Determination Day -50 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05508 I05517 I05519 I05520 I05526 I05527 54.69 49.55 64.74 47.30 60.37 50.69 14.54 3.04 6.12 10.74 0.09 6.48 MEAN S.D. N 54.56 6.785 6 6.84 5.199 6 Group: Male 2 Dose Level: 0.03 I05514 I05515 I05516 I05521 71.04 38.63 58.36 58.05 1.18 9.81 0.34 14.26 MEAN S.D. N 56.52 13.374 4 6.40 6.767 4 Group: Male 3 Dose Level: 0.15 I05505 I05510 I05518 I05523 I05524 I05528 48.00 38.05 50.92 56.98 62.46 63.18 3.04 0.41 3.77 4.38 1.02 0.97 MEAN S.D. N 53.27 9.606 6 2.27 1.674 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 29.48 51.76 31.21 30.92 31.69 43.40 20.01 54.86 17.51 39.76 27.63 24.47 0.00 0.00 0.00 0.00 0.00 0.00 36.41 9.077 6 30.71 14.158 6 0.00 0.000 6 Dosage Unit: mg/kg/day 38.90 27.91 32.30 59.78 51.37 17.75 29.41 62.35 0.00 0.00 0.00 0.00 39.72 14.114 4 40.22 20.296 4 0.00 0.000 4 Dosage Unit: mg/kg/day 43.24 23.74 53.56 43.26 30.26 26.50 30.43 26.96 28.80 39.35 26.55 18.67 0.00 0.00 0.00 0.00 0.00 0.00 36.76 11.692 6 28.46 6.698 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 0.44 0.98 0.92 2.11 0.86 3.34 1.44 1.084 6 1.44 1.04 1.13 1.45 1.27 0.211 4 1.20 0.60 1.67 0.00 0.62 1.04 0.86 0.578 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 89.59 125.67 82.21 122.59 132.25 102.72 109.17 20.673 6 133.26 83.16 138.37 130.08 121.22 25.600 4 122.64 115.95 124.80 162.12 117.52 113.68 126.12 18.122 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.96 3.25 5.11 3.13 3.80 3.52 3.96 0.864 6 6.14 3.32 8.91 4.56 5.73 2.412 4 5.60 3.48 4.29 6.48 4.28 4.49 4.77 1.079 6 917 Appendix 6 Summary and Individual Blood Hormone Determination Day -50 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 4 Dose Level: 0.75 I05506 I05507 I05509 I05511 I05512 I05522 46.92 41.20 65.60 48.27 49.15 44.81 3.31 21.45 2.21 18.86 0.29 12.56 MEAN S.D. N 49.33 8.464 6 9.78 9.117 6 Group: Female 1 Dose Level: 0 I05529 I05530 I05531 I05535 I05544 I05549 68.63 64.90 55.89 51.86 55.61 52.20 0.49 0.03 0.36 0.38 0.38 0.04 MEAN S.D. N 58.18 6.956 6 0.28 0.195 6 Group: Female 2 Dose Level: 0.03 I05537 I05541 I05547 I05550 73.24 82.66 71.82 46.90 0.19 0.66 0.16 0.29 MEAN S.D. N 68.66 15.280 4 0.33 0.230 4 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 26.45 49.83 30.80 32.75 38.12 49.93 29.18 33.79 24.47 46.01 22.90 48.77 0.00 0.00 0.00 0.00 0.00 0.00 37.98 9.951 6 34.19 10.950 6 0.00 0.000 6 Dosage Unit: mg/kg/day 48.75 48.53 53.05 50.13 37.23 50.33 38.12 32.43 61.53 31.55 26.87 27.55 0.00 0.00 0.00 0.00 0.00 0.00 48.0 5.519 6 36.34 12.984 6 0.00 0.000 6 Dosage Unit: mg/kg/day 91.05 60.36 55.87 50.49 129.22 42.73 39.96 46.09 0.00 0.00 0.00 0.00 64.44 18.191 4 64.50 43.219 4 0.00 0.000 4 THYROID STIMULATING U/mL ------------------- 0.08 1.45 1.81 0.42 0.60 1.66 1.00 0.726 6 0.75 0.74 0.30 1.14 2.67 0.69 1.05 0.838 6 0.00 0.65 0.79 0.88 0.58 0.398 4 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 148.18 113.67 112.11 152.20 162.79 151.90 140.14 21.669 6 91.26 153.02 45.26 128.93 96.13 87.95 100.43 37.095 6 158.33 140.97 115.35 107.01 130.42 23.561 4 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.90 4.66 5.14 4.13 4.63 3.36 4.47 0.639 6 5.25 8.79 16.59 3.80 4.13 4.43 7.17 4.963 6 6.80 6.99 4.66 4.27 5.68 1.414 4 918 Appendix 6 Summary and Individual Blood Hormone Determination Day -50 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 3 Dose Level: 0.15 I05532 I05538 I05539 I05545 I05548 I05552 56.59 51.32 66.59 63.69 65.26 49.09 0.13 0.23 0.34 0.25 0.45 0.33 MEAN S.D. N 58.76 7.502 6 0.29 0.110 6 Group: Female 4 Dose Level: 0.75 I05533 I05534 I05536 I05540 I05542 I05551 58.99 59.49 51.68 46.17 87.39 67.04 0.35 0.05 0.29 0.15 0.63 0.38 MEAN S.D. N 61.79 14.438 6 0.31 0.201 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 51.67 52.69 129.12 176.45 63.53 23.32 35.53 35.81 82.62 132.50 47.80 15.96 0.00 0.00 0.00 0.00 0.00 0.00 82.80 57.794 6 58.37 42.484 6 0.00 0.000 6 Dosage Unit: mg/kg/day 96.99 42.90 47.76 54.58 39.07 86.86 64.39 34.98 46.31 88.38 31.81 107.99 0.00 0.00 0.00 0.00 0.00 0.00 61.36 24.447 6 62.31 30.672 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 4.46 0.00 1.48 0.67 0.00 1.52 1.36 1.663 6 2.10 0.98 0.17 1.51 0.32 0.21 0.88 0.795 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 64.50 137.04 117.92 135.57 104.23 71.94 105.20 31.182 6 101.63 97.38 124.27 126.16 109.29 95.16 108.98 13.480 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 5.49 3.21 5.68 5.05 4.24 6.35 5.00 1.123 6 4.25 4.94 5.78 5.23 6.44 5.78 5.40 0.766 6 919 Appendix 6 Summary and Individual Blood Hormone Determination Day -40 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05508 I05517 I05519 I05520 I05526 I05527 57.43 43.65 71.52 52.42 84.79 79.36 3.30 2.35 0.37 11.10 0.21 5.72 MEAN S.D. N 64.86 16.197 6 3.84 4.098 6 Group: Male 2 Dose Level: 0.03 I05514 I05515 I05516 I05521 79.55 67.38 87.16 62.83 1.10 5.86 0.19 9.82 MEAN S.D. N 74.23 11.141 4 4.24 4.473 4 Group: Male 3 Dose Level: 0.15 I05505 I05510 I05518 I05523 I05524 I05528 50.93 77.83 67.52 61.48 63.60 72.30 4.07 0.53 0.93 1.81 0.68 6.04 MEAN S.D. N 65.61 9.320 6 2.34 2.235 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 23.93 42.46 32.19 46.29 26.36 33.96 11.61 29.34 19.63 35.48 20.87 34.93 0.00 0.00 0.00 0.00 0.00 0.00 34.20 8.780 6 25.31 9.507 6 0.00 0.000 6 Dosage Unit: mg/kg/day 35.50 21.00 23.13 63.80 4.64 28.82 23.58 49.29 0.00 0.00 0.00 0.00 35.86 19.695 4 26.58 18.359 4 0.00 0.000 4 Dosage Unit: mg/kg/day 45.97 31.51 45.46 34.64 31.45 28.17 18.34 17.29 25.93 27.49 16.37 13.10 0.00 0.00 0.00 0.00 0.00 0.00 36.20 7.651 6 19.75 5.688 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 0.26 0.50 0.56 0.34 1.13 0.95 0.62 0.345 6 1.16 0.21 0.94 1.12 0.86 0.442 4 0.85 0.69 1.87 0.00 0.75 0.00 0.69 0.689 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 113.08 104.32 122.61 137.32 154.19 99.03 121.76 20.932 6 140.65 97.32 127.13 120.13 121.31 18.118 4 130.66 104.25 145.93 136.56 107.44 111.71 122.76 17.258 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.24 2.99 5.26 3.54 3.86 4.72 4.10 0.819 6 6.28 4.57 5.92 6.34 5.78 0.826 4 6.01 3.94 4.76 5.13 4.14 3.63 4.60 0.881 6 920 Appendix 6 Summary and Individual Blood Hormone Determination Day -40 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 4 Dose Level: 0.75 I05506 I05507 I05509 I05511 I05512 I05522 49.42 44.53 82.95 75.12 81.05 58.08 1.27 7.01 1.03 16.78 0.14 10.11 MEAN S.D. N 65.19 16.683 6 6.06 6.565 6 Group: Female 1 Dose Level: 0 I05529 I05530 I05531 I05535 I05544 I05549 81.80 70.50 85.44 85.08 89.58 66.75 0.41 0.01 0.25 0.37 0.44 0.15 MEAN S.D. N 79.86 9.123 6 0.27 0.168 6 Group: Female 2 Dose Level: 0.03 I05537 I05541 I05547 I05550 79.24 108.45 67.50 89.13 0.17 0.77 0.19 0.23 MEAN S.D. N 86.08 17.337 4 0.34 0.288 4 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 28.98 32.46 27.21 37.12 37.24 52.20 21.20 30.79 14.40 42.06 21.98 49.26 0.00 0.00 0.00 0.00 0.00 0.00 35.87 8.991 6 29.95 13.432 6 0.00 0.000 6 Dosage Unit: mg/kg/day 42.94 90.55 52.80 79.48 72.70 50.29 31.46 65.47 91.87 52.46 46.44 34.57 0.00 0.00 0.00 0.00 0.00 0.00 64.79 18.833 6 53.71 22.407 6 0.00 0.000 6 Dosage Unit: mg/kg/day 59.21 116.25 40.43 62.40 48.11 90.73 67.42 61.31 0.00 0.00 0.00 0.00 69.57 32.593 4 66.89 17.818 4 0.00 0.000 4 THYROID STIMULATING U/mL ------------------- 0.82 1.92 0.57 0.59 0.25 1.54 0.95 0.643 6 0.00 0.00 0.11 0.73 2.16 0.69 0.62 0.827 6 0.01 0.26 1.14 0.93 0.59 0.536 4 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 157.93 88.90 116.45 188.61 169.66 158.85 146.73 36.914 6 75.62 128.68 73.71 125.42 106.71 76.27 97.74 25.813 6 131.29 132.70 86.87 88.98 109.96 25.465 4 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 5.12 6.69 4.44 4.90 3.80 3.42 4.73 1.157 6 4.60 5.65 4.93 4.02 3.73 4.49 4.57 0.680 6 6.03 6.63 4.59 2.99 5.06 1.624 4 921 Appendix 6 Summary and Individual Blood Hormone Determination Day -40 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 3 Dose Level: 0.15 I05532 I05538 I05539 I05545 I05548 I05552 63.15 70.84 68.60 64.50 67.75 53.55 0.06 0.08 0.35 0.13 0.66 0.40 MEAN S.D. N 64.73 6.148 6 0.28 0.234 6 Group: Female 4 Dose Level: 0.75 I05533 I05534 I05536 I05540 I05542 I05551 69.41 60.42 66.67 65.40 92.90 64.20 0.73 0.28 0.15 0.08 0.32 0.42 MEAN S.D. N 69.83 11.681 6 0.33 0.230 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 33.18 53.04 492.12 114.49 75.11 45.64 29.09 40.85 272.75 81.43 55.06 48.94 0.00 0.00 0.00 0.00 0.00 0.00 135.60 176.980 6 88.02 92.174 6 0.00 0.000 6 Dosage Unit: mg/kg/day 90.70 60.87 66.36 35.46 59.88 76.86 76.17 66.05 59.95 33.64 43.92 82.48 0.00 0.00 0.00 0.00 0.00 0.00 65.02 18.541 6 60.37 18.740 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 1.38 0.00 1.33 0.17 0.00 2.13 0.84 0.901 6 0.00 0.13 0.04 1.39 1.02 0.24 0.47 0.587 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 95.64 114.53 114.65 106.43 116.19 82.66 105.02 13.401 6 108.13 81.98 114.01 119.54 151.57 108.31 113.92 22.513 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.36 3.19 6.09 4.61 4.02 4.69 4.49 0.953 6 4.03 4.39 5.41 4.36 7.00 5.21 5.07 1.087 6 922 Appendix 6 Summary and Individual Blood Hormone Determination Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05508 I05517 I05519 I05520 I05526 I05527 59.85 50.40 74.30 55.75 72.92 67.71 2.60 2.25 0.40 3.11 0.48 2.43 MEAN S.D. N 63.49 9.676 6 1.88 1.151 6 Group: Male 2 Dose Level: 0.03 I05514 I05515 I05516 I05521 81.35 77.44 50.15 61.80 1.41 1.40 0.31 3.03 MEAN S.D. N 67.69 14.422 4 1.54 1.121 4 Group: Male 3 Dose Level: 0.15 I05505 I05510 I05518 I05523 I05524 I05528 58.10 68.33 54.45 66.60 91.70 69.75 5.40 0.38 1.06 2.36 1.11 0.74 MEAN S.D. N 68.16 13.025 6 1.84 1.867 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 18.82 35.11 25.09 29.31 22.23 29.56 27.46 41.06 31.24 51.38 21.97 26.74 0.00 0.00 0.00 0.00 0.00 0.00 26.69 5.838 6 33.31 10.926 6 0.00 0.000 6 Dosage Unit: mg/kg/day 31.71 26.17 29.91 40.47 43.75 32.63 35.52 57.63 0.00 0.00 0.00 0.00 32.07 6.060 4 42.38 11.204 4 0.00 0.000 4 Dosage Unit: mg/kg/day 30.42 25.88 26.53 25.62 23.61 22.60 27.04 22.77 39.19 37.12 32.22 21.66 0.00 0.00 0.00 0.00 0.00 0.00 25.78 2.718 6 30.00 7.358 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.000 6 0.00 0.00 0.00 0.00 0.00 0.000 4 0.00 0.00 0.32 0.00 0.00 0.00 0.05 0.131 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 101.15 112.05 112.26 115.75 127.37 92.95 110.26 11.939 6 120.88 126.21 97.87 105.02 112.50 13.269 4 117.98 114.00 149.51 140.05 86.43 100.82 118.13 23.608 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 3.82 3.11 4.39 2.89 2.83 3.90 3.49 0.637 6 5.30 2.51 5.85 4.16 4.46 1.475 4 5.76 3.90 4.50 6.33 3.74 3.55 4.63 1.155 6 923 Appendix 6 Summary and Individual Blood Hormone Determination Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 4 Dose Level: 0.75 I05506 I05507 I05509 I05511 I05512 I05522 47.35 48.45 71.85 71.00 65.67 61.00 0.85 1.81 1.13 2.40 0.17 3.96 MEAN S.D. N 60.89 10.801 6 1.72 1.341 6 Group: Female 1 Dose Level: 0 I05529 I05530 I05531 I05535 I05544 I05549 72.55 76.75 48.35 68.60 52.84 55.44 0.28 0.07 0.50 0.35 0.42 0.07 MEAN S.D. N 62.42 11.701 6 0.28 0.179 6 Group: Female 2 Dose Level: 0.03 I05537 I05541 I05547 I05550 80.90 66.41 83.87 47.16 0.16 0.17 0.46 0.31 MEAN S.D. N 69.59 16.783 4 0.28 0.141 4 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 26.15 32.25 24.92 24.62 33.79 36.25 31.68 32.53 22.42 48.45 36.30 41.15 0.00 0.00 0.00 0.00 0.00 0.00 29.66 5.047 6 35.42 8.885 6 0.00 0.000 6 Dosage Unit: mg/kg/day 35.08 122.95 75.71 61.83 208.06 45.31 49.80 102.72 92.55 59.99 101.29 59.93 0.00 0.00 0.00 0.00 0.00 0.00 91.49 64.841 6 77.71 23.710 6 0.00 0.000 6 Dosage Unit: mg/kg/day 63.92 70.21 65.82 44.95 82.77 78.87 70.18 119.41 0.00 0.00 0.00 0.00 61.23 11.165 4 87.81 21.716 4 0.00 0.000 4 THYROID STIMULATING U/mL ------------------- 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.000 6 0.00 0.01 0.00 0.00 1.26 0.00 0.21 0.514 6 0.00 0.00 0.00 0.00 0.00 0.000 4 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 149.78 117.94 130.15 137.80 128.50 133.19 132.89 10.581 6 82.65 184.14 90.39 109.23 145.88 99.05 118.56 38.982 6 167.85 119.83 284.36 110.60 170.66 79.847 4 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 5.35 6.72 5.49 4.61 3.49 3.60 4.88 1.235 6 4.40 8.76 8.31 5.76 5.54 5.97 6.46 1.705 6 9.01 7.95 6.35 4.93 7.06 1.792 4 924 Appendix 6 Summary and Individual Blood Hormone Determination Day -27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 3 Dose Level: 0.15 I05532 I05538 I05539 I05545 I05548 I05552 57.80 87.05 50.45 57.66 56.95 62.72 0.18 0.09 0.08 0.03 0.59 0.54 MEAN S.D. N 62.11 12.832 6 0.25 0.248 6 Group: Female 4 Dose Level: 0.75 I05533 I05534 I05536 I05540 I05542 I05551 80.05 71.00 48.50 68.05 82.95 63.39 0.55 0.19 0.16 0.05 0.37 0.18 MEAN S.D. N 68.99 12.436 6 0.25 0.179 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 73.31 34.86 45.40 97.36 80.60 35.64 64.68 46.45 87.24 92.73 76.53 71.52 0.00 0.00 0.00 0.00 0.00 0.00 61.20 26.181 6 73.19 16.617 6 0.00 0.000 6 Dosage Unit: mg/kg/day 197.69 75.81 51.69 27.69 53.10 133.61 243.31 98.79 75.52 27.51 54.14 259.85 0.00 0.00 0.00 0.00 0.00 0.00 89.93 63.894 6 126.52 99.828 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 1.98 0.00 0.00 0.00 0.00 0.08 0.34 0.802 6 0.04 0.00 0.00 0.00 0.00 0.00 0.01 0.016 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 221.66 133.62 122.82 126.61 125.43 99.82 138.33 42.411 6 298.47 161.23 130.92 94.60 124.93 119.61 154.96 73.494 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 8.42 6.15 8.69 7.04 5.95 6.53 7.13 1.168 6 7.38 6.76 6.89 4.96 8.88 7.73 7.10 1.295 6 925 Appendix 6 Summary and Individual Blood Hormone Determination Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05508 I05517 I05519 I05520 I05526 I05527 59.57 58.12 56.30 51.45 54.80 56.59 0.56 1.38 0.36 2.11 0.89 10.76 MEAN S.D. N 56.14 2.818 6 2.68 4.010 6 Group: Male 2 Dose Level: 0.03 I05514 I05515 I05516 I05521 72.96 56.42 53.39 60.98 2.64 0.94 0.22 10.10 MEAN S.D. N 60.94 8.601 4 3.48 4.532 4 Group: Male 3 Dose Level: 0.15 I05505 I05510 I05518 I05523 I05524 I05528 61.35 66.10 52.23 61.98 64.07 73.61 0.76 0.60 0.83 2.11 0.68 1.04 MEAN S.D. N 63.22 6.968 6 1.00 0.563 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 14.21 30.66 19.61 31.75 17.02 31.22 21.01 42.28 34.97 65.45 32.02 47.15 0.00 0.00 0.00 0.00 0.00 0.00 24.08 8.004 6 40.48 15.181 6 0.00 0.000 6 Dosage Unit: mg/kg/day 32.81 23.69 14.32 37.38 84.41 39.25 48.23 98.72 0.00 0.00 0.00 0.00 27.05 10.218 4 67.65 28.460 4 0.00 0.000 4 Dosage Unit: mg/kg/day 23.37 24.13 26.75 27.07 15.77 10.40 36.78 29.76 38.59 44.88 33.62 23.33 0.00 0.00 0.00 0.00 0.00 0.00 21.25 6.703 6 34.49 7.452 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 0.02 0.86 0.00 0.00 0.47 0.70 0.34 0.387 6 0.70 0.43 0.13 0.14 0.35 0.272 4 0.07 0.68 0.92 0.00 0.32 0.01 0.33 0.387 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 252.81 298.92 279.29 241.26 316.62 250.74 273.27 30.081 6 306.12 283.59 272.54 229.90 273.04 31.973 4 265.64 255.41 272.85 284.01 221.20 228.32 254.57 25.007 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 3.21 4.67 4.18 4.63 3.30 4.37 4.06 0.649 6 6.21 3.96 4.83 5.43 5.11 0.951 4 4.21 4.29 3.46 5.45 3.41 3.17 4.00 0.844 6 926 Appendix 6 Summary and Individual Blood Hormone Determination Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 4 Dose Level: 0.75 I05506 I05507 I05509 I05511 I05512 I05522 60.57 69.37 86.47 75.68 64.22 53.06 1.13 14.80 1.24 1.50 0.25 37.59 MEAN S.D. N 68.23 11.785 6 9.42 14.866 6 Group: Female 1 Dose Level: 0 I05529 I05530 I05531 I05535 I05544 I05549 58.61 77.09 60.99 61.72 62.18 56.68 0.31 0.08 0.20 0.25 0.46 0.18 MEAN S.D. N 62.88 7.266 6 0.25 0.130 6 Group: Female 2 Dose Level: 0.03 I05537 I05541 I05547 I05550 76.40 81.53 63.15 64.55 0.23 0.31 0.39 0.27 MEAN S.D. N 71.41 8.993 4 0.30 0.068 4 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 24.16 51.78 17.49 6.35 21.10 69.66 182.56 91.86 35.79 35.89 39.97 162.36 0.00 0.00 0.00 0.00 0.00 0.00 31.76 23.908 6 91.41 66.580 6 0.00 0.000 6 Dosage Unit: mg/kg/day 42.85 39.24 88.53 40.91 75.30 65.95 72.21 74.66 208.96 63.01 65.02 56.58 0.00 0.00 0.00 0.00 0.00 0.00 58.80 20.805 6 90.07 58.605 6 0.00 0.000 6 Dosage Unit: mg/kg/day 64.21 61.86 45.86 55.39 177.41 127.77 76.97 143.29 0.00 0.00 0.00 0.00 56.83 8.209 4 131.36 41.770 4 0.00 0.000 4 THYROID STIMULATING U/mL ------------------- 0.00 0.36 0.66 0.14 0.04 0.03 0.21 0.259 6 0.18 0.69 0.27 0.40 2.61 0.21 0.73 0.941 6 0.00 0.01 0.68 0.27 0.24 0.319 4 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 229.83 199.81 259.19 230.58 246.92 270.21 239.42 25.037 6 256.85 189.21 211.24 267.83 216.47 236.08 229.61 29.621 6 279.90 240.82 223.65 232.10 244.12 24.864 4 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 3.61 3.33 4.31 4.22 2.99 3.18 3.61 0.549 6 5.54 8.01 6.09 5.64 4.38 5.23 5.82 1.217 6 6.02 6.09 4.37 3.75 5.06 1.180 4 927 Appendix 6 Summary and Individual Blood Hormone Determination Day 37 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 3 Dose Level: 0.15 I05532 I05538 I05539 I05545 I05548 I05552 66.39 54.30 50.23 46.45 46.73 56.82 0.20 0.07 0.08 0.09 0.30 0.48 MEAN S.D. N 53.49 7.537 6 0.20 0.162 6 Group: Female 4 Dose Level: 0.75 I05533 I05534 I05536 I05540 I05542 I05551 63.27 53.74 55.56 54.54 54.14 68.07 0.29 0.15 0.19 0.07 0.09 0.12 MEAN S.D. N 58.22 5.998 6 0.15 0.080 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 383.80 27.95 38.80 119.09 34.02 27.36 351.81 58.49 86.17 227.52 52.35 51.92 0.00 0.00 0.00 0.00 0.00 0.00 105.17 140.935 6 138.04 124.485 6 0.00 0.000 6 Dosage Unit: mg/kg/day 70.06 49.92 42.44 31.28 67.52 104.58 150.87 123.86 63.03 47.69 67.27 271.41 0.00 0.00 0.00 0.00 0.00 0.00 60.97 25.978 6 120.69 83.839 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 1.56 0.00 1.21 0.00 0.00 0.91 0.61 0.703 6 1.07 1.59 0.00 0.26 0.52 0.10 0.59 0.622 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 192.15 225.80 221.63 237.82 184.62 220.15 213.70 20.701 6 190.90 203.76 204.79 191.80 196.18 190.95 196.40 6.414 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.53 3.21 3.49 4.18 2.78 3.89 3.68 * 0.646 6 3.51 5.03 3.62 3.16 4.84 5.21 4.23 * 0.895 6 928 Appendix 6 Summary and Individual Blood Hormone Determination Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05508 I05517 I05519 I05520 I05526 I05527 64.62 57.71 60.20 50.13 63.25 43.13 0.50 1.30 0.39 2.28 0.65 1.40 MEAN S.D. N 56.51 8.318 6 1.09 0.719 6 Group: Male 2 Dose Level: 0.03 I05514 I05515 I05516 I05521 86.10 59.33 49.45 62.77 2.10 0.67 0.27 3.13 MEAN S.D. N 64.41 15.522 4 1.54 1.318 4 Group: Male 3 Dose Level: 0.15 I05505 I05510 I05518 I05523 I05524 I05528 70.82 58.68 60.80 76.60 62.76 63.38 1.07 0.51 0.77 2.83 0.94 0.77 MEAN S.D. N 65.51 6.813 6 1.15 0.845 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 17.70 35.89 27.43 27.41 15.13 38.03 28.21 51.07 24.22 69.97 34.66 42.05 0.00 0.00 0.00 0.00 0.00 0.00 26.93 9.256 6 41.70 16.877 6 0.00 0.000 6 Dosage Unit: mg/kg/day 29.19 27.02 17.22 44.97 71.76 53.19 77.85 95.20 0.00 0.00 0.00 0.00 29.60 11.494 4 74.50 * 17.333 4 0.00 0.000 4 Dosage Unit: mg/kg/day 34.40 25.73 31.30 35.79 21.61 14.54 36.91 26.22 30.11 62.53 31.79 33.29 0.00 0.00 0.00 0.00 0.00 0.00 27.23 8.199 6 36.81 13.086 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 0.25 1.72 0.00 0.00 0.00 1.42 0.57 0.790 6 0.54 0.11 0.47 0.57 0.42 0.213 4 1.22 1.53 2.85 0.00 0.00 0.29 0.98 1.118 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 119.34 163.61 145.97 164.61 139.41 135.30 144.71 17.407 6 147.03 143.03 118.77 148.62 139.36 13.928 4 131.32 117.68 167.15 166.99 135.36 131.96 141.74 20.528 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 2.89 2.79 2.77 3.81 1.73 2.55 2.76 0.667 6 4.36 3.15 4.47 3.64 3.91 * 0.624 4 3.22 2.56 2.73 4.44 2.60 2.90 3.08 0.711 6 929 Appendix 6 Summary and Individual Blood Hormone Determination Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 4 Dose Level: 0.75 I05506 I05507 I05509 I05511 I05512 I05522 70.92 69.36 80.21 83.50 69.38 65.14 0.61 2.05 1.10 1.52 0.19 1.87 MEAN S.D. N 73.09 * 7.137 6 1.22 0.728 6 Group: Female 1 Dose Level: 0 I05529 I05530 I05531 I05535 I05544 I05549 73.17 80.23 63.57 77.78 72.02 67.18 0.25 0.03 0.23 0.29 0.24 0.11 MEAN S.D. N 72.33 6.264 6 0.19 0.100 6 Group: Female 2 Dose Level: 0.03 I05537 I05541 I05547 I05550 75.87 88.44 67.51 72.45 0.24 0.30 0.41 0.42 MEAN S.D. N 76.07 8.934 4 0.34 0.087 4 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 6.89 14.27 8.28 4.43 20.03 30.27 84.83 50.89 33.16 43.47 35.68 56.44 0.00 0.00 0.00 0.00 0.00 0.00 14.03 9.757 6 50.75 18.886 6 0.00 0.000 6 Dosage Unit: mg/kg/day 42.49 40.60 87.01 135.19 110.97 88.68 95.52 73.45 154.45 166.44 116.03 104.97 0.00 0.00 0.00 0.00 0.00 0.00 84.16 37.377 6 118.48 35.602 6 0.00 0.000 6 Dosage Unit: mg/kg/day 97.35 95.89 71.56 63.70 171.29 128.24 149.12 160.38 0.00 0.00 0.00 0.00 82.13 17.053 4 152.26 18.393 4 0.00 0.000 4 THYROID STIMULATING U/mL ------------------- 0.00 0.33 0.97 0.00 0.00 0.00 0.22 0.392 6 2.88 0.32 0.00 0.00 3.86 0.10 1.19 1.718 6 0.00 0.09 1.74 0.00 0.46 0.856 4 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 110.61 96.11 120.78 133.14 121.31 142.07 120.67 16.237 6 86.34 157.85 105.00 104.25 94.26 141.85 114.93 28.369 6 178.52 124.69 122.85 116.15 135.55 28.879 4 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 2.24 2.24 3.01 3.42 1.84 2.79 2.59 0.585 6 2.55 5.01 3.16 3.14 3.32 3.98 3.53 0.859 6 4.64 5.27 3.51 2.87 4.07 1.083 4 930 Appendix 6 Summary and Individual Blood Hormone Determination Day 62 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 3 Dose Level: 0.15 I05532 I05538 I05539 I05545 I05548 I05552 63.46 62.14 65.91 60.86 48.14 61.25 0.05 0.06 0.00 0.05 0.36 0.44 MEAN S.D. N 60.29 6.228 6 0.16 0.189 6 Group: Female 4 Dose Level: 0.75 I05533 I05534 I05536 I05540 I05542 I05551 68.36 67.55 73.98 73.87 66.81 113.15 1.04 0.05 0.12 0.09 0.40 0.10 MEAN S.D. N 77.29 17.850 6 0.30 0.384 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 196.89 40.91 50.54 142.62 60.76 60.28 162.41 57.31 122.72 226.73 96.83 85.06 0.00 0.00 0.00 0.00 0.00 0.00 92.00 63.048 6 125.18 61.195 6 0.00 0.000 6 Dosage Unit: mg/kg/day 539.64 21.16 53.49 47.69 414.10 98.43 637.44 92.30 103.29 87.57 248.93 208.43 0.00 0.00 0.00 0.00 0.00 0.00 195.75 222.733 6 229.66 210.776 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 3.00 0.00 1.30 0.00 0.48 0.13 0.82 1.176 6 1.64 1.91 0.17 0.00 0.69 0.00 0.74 0.849 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 100.87 122.69 109.98 147.17 99.01 102.13 113.64 18.596 6 92.49 104.34 101.67 102.37 84.83 85.64 95.22 8.753 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.30 1.97 3.15 2.68 1.94 2.55 2.77 0.880 6 2.41 3.70 2.53 1.65 3.75 4.45 3.08 1.049 6 931 Appendix 6 Summary and Individual Blood Hormone Determination Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05508 I05517 I05519 I05520 I05526 I05527 63.12 72.02 68.04 50.11 60.09 48.19 0.65 1.78 0.44 2.53 0.96 1.57 MEAN S.D. N 60.26 9.547 6 1.32 0.786 6 Group: Male 2 Dose Level: 0.03 I05514 I05515 I05516 I05521 70.30 48.85 58.29 64.30 1.86 0.96 0.34 10.76 MEAN S.D. N 60.44 9.148 4 3.48 4.893 4 Group: Male 3 Dose Level: 0.15 I05505 I05510 I05518 I05523 I05524 I05528 63.97 58.44 52.27 64.33 73.62 72.47 1.54 1.05 0.90 2.03 0.82 0.73 MEAN S.D. N 64.18 8.157 6 1.18 0.506 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 3.16 22.72 14.07 19.55 16.52 35.93 20.61 53.30 30.76 65.61 29.74 51.35 0.00 0.00 0.00 0.00 0.00 0.00 18.66 10.784 6 41.90 17.359 6 0.00 0.000 6 Dosage Unit: mg/kg/day 29.08 29.88 28.37 41.20 82.17 40.06 40.27 107.46 0.00 0.00 0.00 0.00 32.13 * 6.076 4 67.49 33.199 4 0.00 0.000 4 Dosage Unit: mg/kg/day 17.57 20.81 20.88 20.84 13.64 21.33 37.08 34.69 26.72 47.88 34.88 23.84 0.00 0.00 0.00 0.00 0.00 0.00 19.18 3.040 6 34.18 8.478 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.000 6 0.00 0.00 0.00 0.00 0.00 0.000 4 0.00 0.00 0.17 0.00 0.00 0.00 0.03 0.069 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 141.51 162.07 144.10 148.94 161.62 162.45 153.45 9.720 6 166.24 148.07 151.67 146.06 153.01 9.120 4 143.76 141.60 156.52 174.10 119.61 143.77 146.56 18.023 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 3.96 4.25 3.67 4.53 2.93 4.02 3.89 0.553 6 5.41 4.38 5.22 6.17 5.30 * 0.735 4 4.56 4.37 4.49 6.03 3.93 3.45 4.47 0.870 6 932 Appendix 6 Summary and Individual Blood Hormone Determination Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 4 Dose Level: 0.75 I05506 I05507 I05509 I05511 I05512 I05522 73.97 49.60 86.62 60.08 64.66 67.73 0.48 2.71 1.73 1.70 0.26 1.87 MEAN S.D. N 67.11 12.571 6 1.46 0.923 6 Group: Female 1 Dose Level: 0 I05529 I05530 I05531 I05535 I05544 I05549 74.49 69.78 50.36 62.89 70.71 65.26 0.55 0.06 0.30 0.29 1.05 0.32 MEAN S.D. N 65.58 8.513 6 0.43 0.342 6 Group: Female 2 Dose Level: 0.03 I05537 I05541 I05547 I05550 75.93 89.16 68.87 61.58 0.30 0.37 0.38 0.28 MEAN S.D. N 73.89 11.748 4 0.33 0.050 4 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 2.29 22.58 4.65 3.05 13.32 19.66 48.87 40.22 34.03 38.67 33.13 57.55 0.00 0.00 0.00 0.00 0.00 0.00 10.93 8.875 6 42.08 9.438 6 0.00 0.000 6 Dosage Unit: mg/kg/day 59.28 30.39 76.52 126.05 218.24 85.32 96.58 37.67 104.81 94.80 115.65 88.15 0.00 0.00 0.00 0.00 0.00 0.00 99.30 66.222 6 89.61 27.146 6 0.00 0.000 6 Dosage Unit: mg/kg/day 276.11 88.60 48.03 34.29 579.38 143.46 87.11 106.94 0.00 0.00 0.00 0.00 111.76 111.968 4 229.22 234.602 4 0.00 0.000 4 THYROID STIMULATING U/mL ------------------- 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.000 6 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.000 6 0.00 0.00 0.00 0.00 0.00 0.000 4 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 107.40 89.57 127.61 144.57 102.29 136.40 117.97 * 21.468 6 95.65 200.64 117.41 144.43 160.65 139.16 142.99 36.187 6 161.68 144.58 121.55 160.17 147.00 18.641 4 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.98 4.45 4.61 5.46 3.78 4.38 4.61 0.570 6 3.94 6.12 4.52 4.54 4.46 5.01 4.77 0.746 6 5.86 6.55 5.03 6.54 6.00 0.720 4 933 Appendix 6 Summary and Individual Blood Hormone Determination Day 91 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 3 Dose Level: 0.15 I05532 I05538 I05539 I05545 I05548 I05552 53.44 54.36 56.38 50.87 46.19 55.40 0.07 0.09 0.01 0.00 0.30 0.38 MEAN S.D. N 52.77 3.737 6 0.14 0.159 6 Group: Female 4 Dose Level: 0.75 I05533 I05534 I05536 I05540 I05542 I05551 63.67 57.80 71.04 85.09 58.02 91.43 0.51 0.04 0.14 0.26 0.23 0.42 MEAN S.D. N 71.18 14.228 6 0.27 0.174 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 208.42 55.31 48.35 64.59 29.92 74.01 161.28 71.47 96.47 142.80 64.58 74.24 0.00 0.00 0.00 0.00 0.00 0.00 80.10 64.629 6 101.81 40.773 6 0.00 0.000 6 Dosage Unit: mg/kg/day 162.24 34.90 29.06 42.06 95.90 394.36 186.20 67.09 60.95 65.39 72.08 503.53 0.00 0.00 0.00 0.00 0.00 0.00 126.42 140.697 6 159.21 175.397 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 0.09 0.00 0.00 0.00 0.00 0.00 0.02 0.037 6 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.000 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 120.33 113.79 114.24 113.45 109.64 92.26 110.62 * 9.628 6 95.87 81.56 92.51 90.84 81.86 83.67 87.72 * 6.128 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.88 3.27 3.49 4.38 3.13 3.47 3.77 0.697 6 4.18 5.45 4.94 3.81 5.99 5.15 4.92 0.807 6 934 Appendix 6 Summary and Individual Blood Hormone Determination Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05508 I05517 I05519 I05520 I05526 I05527 49.36 44.88 54.72 37.96 60.22 39.62 0.80 0.89 0.41 3.20 0.91 2.05 MEAN S.D. N 47.79 8.681 6 1.38 1.049 6 Group: Male 2 Dose Level: 0.03 I05514 I05515 I05516 I05521 57.72 41.90 43.62 53.31 1.43 0.44 0.31 8.03 MEAN S.D. N 49.14 7.613 4 2.55 3.686 4 Group: Male 3 Dose Level: 0.15 I05505 I05510 I05518 I05523 I05524 I05528 42.54 39.10 46.25 57.87 51.67 52.89 0.25 2.63 0.70 2.06 0.73 0.42 MEAN S.D. N 48.39 7.014 6 1.13 0.973 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 11.03 26.64 21.40 19.07 15.79 43.81 16.55 34.19 24.00 35.67 22.56 46.79 0.00 0.00 0.00 0.00 0.00 0.00 22.96 11.485 6 29.96 10.990 6 0.00 0.000 6 Dosage Unit: mg/kg/day 29.26 9.14 16.57 41.46 65.16 29.60 29.96 70.45 0.00 0.00 0.00 0.00 24.11 14.242 4 48.79 22.060 4 0.00 0.000 4 Dosage Unit: mg/kg/day 28.98 25.43 28.63 26.43 20.26 9.63 21.56 19.76 25.41 39.59 20.89 13.61 0.00 0.00 0.00 0.00 0.00 0.00 23.23 7.363 6 23.47 8.774 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 0.01 1.43 0.48 0.35 0.30 0.02 0.43 0.524 6 0.76 0.32 0.11 0.15 0.34 0.298 4 1.10 0.51 2.09 0.18 0.09 0.46 0.74 0.751 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 153.39 155.85 152.78 168.82 162.99 164.16 159.67 6.579 6 148.24 133.97 77.19 117.72 119.28 * 30.705 4 134.08 110.87 136.26 144.20 114.48 107.88 124.63 * 15.365 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.94 4.14 4.19 4.97 3.38 4.68 4.38 0.608 6 5.02 3.70 5.04 5.13 4.72 0.683 4 4.41 3.40 4.42 4.67 3.94 3.12 3.99 0.621 6 935 Appendix 6 Summary and Individual Blood Hormone Determination Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 4 Dose Level: 0.75 I05507 I05511 I05512 I05522 59.90 43.70 70.20 59.49 2.10 0.69 0.04 1.80 MEAN S.D. N 58.32 10.935 4 1.16 0.961 4 Group: Female 1 Dose Level: 0 I05529 I05530 I05531 I05535 I05544 I05549 65.21 74.89 35.19 74.58 61.62 41.85 0.17 0.01 0.03 0.52 0.34 0.02 MEAN S.D. N 58.89 16.743 6 0.18 0.209 6 Group: Female 2 Dose Level: 0.03 I05537 I05541 I05547 I05550 76.03 61.45 39.39 59.31 0.29 0.13 0.26 0.14 MEAN S.D. N 59.05 15.063 4 0.21 0.082 4 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 0.00 1.01 0.00 2.00 33.59 27.68 22.69 36.89 0.00 0.00 0.00 0.00 0.75 * 0.958 4 30.21 6.298 4 0.00 0.000 4 Dosage Unit: mg/kg/day 232.49 47.22 51.65 318.47 162.44 78.63 351.64 68.58 77.36 239.29 153.92 61.78 0.00 0.00 0.00 0.00 0.00 0.00 148.48 110.143 6 158.76 116.512 6 0.00 0.000 6 Dosage Unit: mg/kg/day 254.69 47.66 41.73 156.72 492.79 101.86 164.10 364.55 0.00 0.00 0.00 0.00 125.20 101.227 4 280.83 180.363 4 0.00 0.000 4 THYROID STIMULATING U/mL ------------------- 1.59 0.34 0.59 1.18 0.93 0.566 4 1.33 0.00 0.00 0.06 2.75 0.22 0.73 1.115 6 0.00 0.08 0.85 1.77 0.68 0.824 4 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 58.09 97.68 34.06 75.57 66.35 * 26.941 4 95.65 183.66 115.47 139.41 152.04 125.36 135.27 30.659 6 148.10 131.20 98.77 102.12 120.05 23.703 4 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 5.27 7.00 3.25 5.85 5.34 1.569 4 4.83 7.22 5.01 5.84 5.08 5.95 5.66 0.894 6 5.29 5.85 3.35 2.84 4.33 1.462 4 936 Appendix 6 Summary and Individual Blood Hormone Determination Day 182 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 3 Dose Level: 0.15 I05532 I05538 I05539 I05545 I05548 I05552 47.71 36.38 42.82 48.24 32.13 48.26 0.01 0.04 0.00 0.04 0.03 0.16 MEAN S.D. N 42.59 6.904 6 0.05 0.058 6 Group: Female 4 Dose Level: 0.75 I05533 I05534 I05536 I05540 I05542 I05551 63.42 66.38 51.73 60.27 56.03 96.30 0.17 0.05 0.09 0.15 0.19 0.07 MEAN S.D. N 65.69 15.876 6 0.12 0.058 6 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 197.86 45.10 52.30 52.62 39.61 36.02 141.98 64.69 100.79 74.46 51.74 60.51 0.00 0.00 0.00 0.00 0.00 0.65 70.59 62.705 6 82.36 33.716 6 0.11 0.265 6 Dosage Unit: mg/kg/day 36.11 9.45 0.00 47.41 93.61 52.80 55.31 37.27 53.37 60.05 115.82 99.85 0.00 0.00 0.00 0.00 0.00 0.00 39.90 33.589 6 70.28 30.505 6 0.00 0.000 6 THYROID STIMULATING U/mL ------------------- 4.33 0.25 0.89 0.62 0.98 0.57 1.27 1.520 6 2.31 1.10 0.62 0.21 0.55 0.22 0.84 0.793 6 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 90.44 100.45 106.11 86.22 103.15 93.10 96.58 * 7.824 6 83.76 81.38 76.41 71.65 92.22 104.92 85.06 * 11.963 6 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.36 2.83 3.63 4.00 4.03 4.59 3.91 * 0.622 6 5.31 6.31 5.96 3.74 5.83 6.49 5.61 1.002 6 937 Appendix 6 Summary and Individual Blood Hormone Determination Additional Collection - Terminal Sacrifice 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL -------- Group: Male 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05519 I05527 126.89 110.98 107.16 5.18 3.61 3.83 3.46 2.73 3.56 1.02 0.86 1.15 MEAN S.D. N 115.01 10.464 3 4.21 0.850 3 3.25 0.453 3 1.01 0.145 3 Group: Male 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 111.98 103.61 120.14 106.40 5.14 4.58 5.44 5.36 3.97 3.01 4.11 4.31 1.07 1.10 1.16 1.50 MEAN S.D. N 110.53 7.289 4 5.13 0.388 4 3.85 0.577 4 1.21 0.199 4 Group: Male 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05510 I05518 I05524 I05528 95.90 93.03 86.79 100.26 4.19 4.41 3.88 4.85 2.88 2.49 2.38 3.07 1.02 0.93 0.79 1.01 MEAN S.D. N 94.00 * 5.649 4 4.33 0.408 4 2.71 0.324 4 0.94 0.106 4 Covance 6329-223 3M T-6295.7 938 Appendix 6 Summary and Individual Blood Hormone Determination Additional Collection - Terminal Sacrifice 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL --------- Group: Male 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05512 59.28 55.46 13.96 2.74 3.07 1.55 4.90 3.16 1.83 1.36 1.15 0.86 MEAN S.D. N 42.90 * 25.135 3 2.45 * 0.800 3 3.30 1.540 3 1.12 0.251 3 Group: Female 1 Dose Level: 0 Dosage Unit: mg/kg/day I05530 I05531 I05535 I05544 131.98 87.43 98.87 104.98 5.33 3.10 3.48 4.28 5.50 2.62 4.93 3.52 1.43 0.78 1.17 0.86 MEAN S.D. N 105.82 18.899 4 4.05 0.986 4 4.14 1.313 4 1.06 0.299 4 Group: Female 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05541 I05547 I05550 109.59 81.34 86.09 4.13 3.14 3.49 4.24 3.41 2.80 1.32 0.86 0.85 MEAN S.D. N 92.34 15.127 3 3.59 0.502 3 3.48 0.723 3 1.01 0.269 3 Covance 6329-223 3M T-6295.7 939 Appendix 6 Summary and Individual Blood Hormone Determination Additional Collection - Terminal Sacrifice 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL --------- Group: Female 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05545 I05548 74.72 77.02 72.24 94.86 3.27 2.98 2.96 3.87 3.03 1.89 2.71 3.88 1.04 0.59 0.90 1.06 MEAN S.D. N 79.71 * 10.287 4 3.27 0.424 4 2.88 0.823 4 0.90 0.217 4 Group: Female 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05534 I05536 I05540 I05551 51.14 59.03 60.77 64.05 2.88 2.43 3.13 2.83 4.52 3.87 2.04 3.30 1.49 1.00 0.79 1.03 MEAN S.D. N 58.75 * 5.482 4 2.82 0.290 4 3.43 1.054 4 1.08 0.295 4 Covance 6329-223 3M T-6295.7 940 Appendix 6 Summary and Individual Blood Hormone Determination Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05520 I05526 38.18 44.16 2.66 2.51 MEAN S.D. N 41.17 4.228 2 2.59 0.106 2 Group: Male 3 Dose Level: 0.15 I05505 I05523 27.26 52.61 0.99 3.84 MEAN S.D. N 39.94 17.925 2 2.42 2.015 2 Group: Male 4 Dose Level: 0.75 I05511 I05522 51.54 44.31 4.72 5.36 MEAN S.D. N 47.93 5.112 2 5.04 0.453 2 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 17.90 10.98 64.49 25.43 0.00 0.00 14.44 4.893 2 44.96 27.620 2 0.00 0.000 2 Dosage Unit: mg/kg/day 17.56 21.73 32.66 59.98 0.00 0.00 19.65 2.949 2 46.32 19.318 2 0.00 0.000 2 Dosage Unit: mg/kg/day 0.00 27.09 37.83 70.81 0.00 0.00 13.55 19.156 2 54.32 23.320 2 0.00 0.000 2 THYROID STIMULATING U/mL ------------------- 1.61 2.12 1.87 0.361 2 1.21 0.97 1.09 0.170 2 1.67 1.05 1.36 0.438 2 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 159.60 183.22 171.41 16.702 2 154.43 164.81 159.62 7.340 2 165.18 129.72 147.45 25.074 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 3.75 2.87 3.31 0.622 2 3.28 4.20 3.74 0.651 2 4.74 2.51 3.625 1.577 2 941 Appendix 6 Summary and Individual Blood Hormone Determination Day 217 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 1 Dose Level: 0 I05529 I05549 54.69 40.39 0.86 0.12 MEAN S.D. N 47.54 10.112 2 0.49 0.523 2 Group: Female 3 Dose Level: 0.15 I05539 I05552 57.55 59.07 0.10 0.82 MEAN S.D. N 58.31 1.075 2 0.46 0.509 2 Group: Female 4 Dose Level: 0.75 I05533 I05542 55.91 66.34 0.61 0.37 MEAN S.D. N 61.13 7.375 2 0.49 0.170 2 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 53.08 43.63 83.74 64.84 0.00 0.00 48.36 6.682 2 74.29 13.364 2 0.00 0.000 2 Dosage Unit: mg/kg/day 44.84 68.85 71.13 88.81 0.00 0.00 56.85 16.978 2 79.97 12.502 2 0.00 0.000 2 Dosage Unit: mg/kg/day 133.46 88.23 289.99 154.68 0.00 0.00 110.85 31.982 2 222.34 95.679 2 0.00 0.000 2 THYROID STIMULATING U/mL ------------------- 1.78 1.66 1.72 0.85 2 1.88 0.59 1.24 0.912 2 1.76 1.56 1.66 0.141 2 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 116.20 133.52 124.86 12.247 2 114.34 121.25 117.80 4.886 2 99.29 101.57 100.43 1.612 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.89 6.58 5.74 1.195 2 3.37 3.91 3.64 0.382 2 3.93 3.51 3.72 0.297 2 942 Appendix 6 Summary and Individual Blood Hormone Determination Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05520 I05526 52.17 44.90 2.83 1.40 MEAN S.D. N 48.54 5.141 2 2.12 1.011 2 Group: Male 3 Dose Level: 0.15 I05505 I05523 46.88 54.44 0.50 7.18 MEAN S.D. N 50.66 5.346 2 3.84 4.723 2 Group: Male 4 Dose Level: 0.75 I05511 I05522 37.08 25.17 1.55 2.99 MEAN S.D. N 31.13 8.422 2 2.27 1.018 2 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 40.85 16.61 79.85 31.48 0.00 0.00 28.73 17.140 2 55.67 34.203 2 0.00 0.000 2 Dosage Unit: mg/kg/day 23.84 25.40 43.65 59.41 0.00 0.00 24.62 1.103 2 51.53 11.144 2 0.00 0.000 2 Dosage Unit: mg/kg/day 17.87 26.57 53.06 77.43 0.00 0.00 22.22 6.152 2 65.25 17.232 2 0.00 0.000 2 THYROID STIMULATING U/mL ------------------- 0.25 0.00 0.13 0.177 2 0.10 0.00 0.05 0.071 2 0.67 0.33 0.50 0.240 2 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 171.00 133.39 152.20 26.594 2 154.84 151.74 153.29 2.192 2 170.42 137.27 153.85 23.441 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.18 1.74 2.96 1.725 2 3.79 3.37 3.58 0.297 2 4.18 2.45 3.32 1.223 2 943 Appendix 6 Summary and Individual Blood Hormone Determination Day 245 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 1 Dose Level: 0 I05529 I05549 56.47 43.54 0.12 0.07 MEAN S.D. N 50.01 9.143 2 0.10 0.035 2 Group: Female 3 Dose Level: 0.15 I05539 I05552 63.10 60.29 0.07 0.28 MEAN S.D. N 61.70 1.987 2 0.18 0.148 2 Group: Female 4 Dose Level: 0.75 I05533 I05542 62.75 81.69 0.66 0.06 MEAN S.D. N 72.22 13.393 2 0.36 0.424 2 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 38.61 112.14 95.66 115.58 0.00 0.00 75.38 51.994 2 105.62 14.086 2 0.00 0.000 2 Dosage Unit: mg/kg/day 61.24 88.08 137.78 94.05 0.00 0.00 74.66 18.979 2 115.92 30.922 2 0.00 0.000 2 Dosage Unit: mg/kg/day 257.61 114.63 255.84 120.11 0.00 0.00 186.12 101.102 2 187.98 95.976 2 0.00 0.000 2 THYROID STIMULATING U/mL ------------------- 0.68 0.98 0.83 0.212 2 0.81 0.00 0.41 0.573 2 1.04 0.82 0.93 0.156 2 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 130.32 136.09 133.21 4.080 2 127.17 142.77 134.97 11.031 2 118.99 121.98 120.49 2.114 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.93 5.81 5.37 0.622 2 3.56 3.76 3.66 0.141 2 3.84 3.38 3.61 0.325 2 944 Appendix 6 Summary and Individual Blood Hormone Determination Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Male 1 Dose Level: 0 I05520 I05526 34.89 45.23 1.76 1.40 MEAN S.D. N 40.06 7.311 2 1.58 0.255 2 Group: Male 3 Dose Level: 0.15 I05505 I05523 42.85 61.34 3.64 2.55 MEAN S.D. N 52.10 13.074 2 3.10 0.771 2 Group: Male 4 Dose Level: 0.75 I05511 I05522 59.62 26.17 2.36 4.12 MEAN S.D. N 42.90 23.653 2 3.24 1.245 2 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 17.17 14.11 62.84 34.27 0.00 0.00 15.64 2.164 2 48.56 20.202 2 0.00 0.000 2 Dosage Unit: mg/kg/day 25.06 25.26 39.86 63.44 0.00 0.00 25.16 0.141 2 51.65 16.674 2 0.00 0.000 2 Dosage Unit: mg/kg/day 6.94 30.46 51.42 83.94 0.00 0.00 18.70 16.631 2 67.68 22.995 2 0.00 0.000 2 THYROID STIMULATING U/mL ------------------- 0.00 0.02 0.01 0.014 2 0.25 0.00 0.13 0.177 2 0.24 0.09 0.17 0.106 2 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 134.97 167.54 151.26 23.030 2 146.70 161.73 154.22 10.628 2 163.13 163.73 163.43 0.424 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 5.56 2.40 3.98 2.234 2 2.43 3.31 2.87 0.622 2 4.19 2.36 3.28 1.294 2 945 Appendix 6 Summary and Individual Blood Hormone Determination Day 274 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ Group: Female 1 Dose Level: 0 I05529 I05549 64.71 47.01 0.44 0.02 MEAN S.D. N 55.86 12.516 2 0.23 0.297 2 Group: Female 3 Dose Level: 0.15 I05539 I05552 45.77 44.48 0.04 0.18 MEAN S.D. N 45.13 0.912 2 0.11 0.099 2 Group: Female 4 Dose Level: 0.75 I05533 I05542 49.13 63.28 0.49 0.40 MEAN S.D. N 56.21 10.006 2 0.45 0.064 2 ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- Dosage Unit: mg/kg/day 43.91 42.07 115.88 57.38 0.00 0.00 42.99 1.301 2 86.63 41.366 2 0.00 0.000 2 Dosage Unit: mg/kg/day 48.03 114.70 127.24 124.21 0.00 0.00 81.37 47.143 2 125.73 2.143 2 0.00 0.000 2 Dosage Unit: mg/kg/day 109.08 108.09 153.99 128.04 0.00 0.00 108.59 0.700 2 141.02 18.349 2 0.00 0.000 2 THYROID STIMULATING U/mL ------------------- 0.00 0.68 0.34 0.481 2 0.29 0.00 0.15 0.205 2 0.64 0.01 0.33 0.445 2 TOTAL TRIIODOTHYRONINE ng/dL ---------------- 91.10 130.21 110.66 27.655 2 114.25 103.46 108.86 7.630 2 115.88 85.17 100.53 21.715 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- 4.88 4.88 4.88 0.000 2 3.00 2.98 2.99 0.014 2 2.59 3.22 2.91 0.445 2 946 Appendix 6 Summary and Individual Blood Hormone Determination Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- THYROID STIMULATING U/mL ----------- TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- Group: Male 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 48.93 54.85 1.68 1.47 22.29 12.73 66.72 34.79 0.00 0.00 0.00 0.08 113.68 167.98 4.34 6.23 MEAN S.D. N 51.89 4.186 2 1.58 0.148 2 17.51 6.760 2 50.76 22.578 2 0.00 0.000 2 0.04 0.057 2 140.83 38.396 2 5.29 1.336 2 Group: Male 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 35.82 56.14 0.16 2.50 21.68 21.64 35.93 55.20 0.00 0.00 0.15 0.00 141.49 150.29 4.68 5.39 MEAN S.D. N 45.98 14.368 2 1.33 1.655 2 21.66 0.028 2 45.57 13.626 2 0.00 0.000 2 0.08 0.106 2 145.89 6.223 2 5.04 0.502 2 Group: Male 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 52.62 27.46 1.59 1.66 0.00 14.90 43.71 66.78 0.00 0.00 0.01 0.05 145.00 116.61 4.78 4.24 MEAN S.D. N 40.04 17.791 2 1.63 0.049 2 7.45 10.536 2 55.25 16.313 2 0.00 0.000 2 0.03 0.028 2 130.81 20.075 2 4.51 0.382 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL -------- 3.20 3.35 3.28 0.106 2 1.27 1.26 1.27 0.007 2 3.96 4.09 4.03 0.092 2 1.44 1.51 1.48 0.049 2 4.61 2.84 3.73 1.252 2 1.17 0.95 1.06 0.156 2 947 ANIMAL NUMBER ------ CORTISOL g/dL -------- Group: Female 1 I05529 I05549 60.74 55.31 MEAN S.D. N 58.03 3.840 2 Group: Female 3 I05539 I05552 54.81 61.78 MEAN S.D. N 58.30 4.929 2 Group: Female 4 I05533 I05542 40.44 66.14 MEAN S.D. N 53.29 18.173 2 Appendix 6 Summary and Individual Blood Hormone Determination Day 322 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS TESTOSTERONE ng/mL ------------ ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- THYROID STIMULATING U/mL ----------- TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- Dose Level: 0 Dosage Unit: mg/kg/day 0.66 0.04 93.93 67.50 136.07 78.68 0.00 0.00 0.14 0.22 95.57 102.40 3.84 3.31 0.35 0.438 2 80.72 18.689 2 107.38 40.581 2 0.00 0.000 2 0.18 0.057 2 98.99 4.830 2 3.58 0.375 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 0.00 0.15 46.03 78.67 127.28 179.51 0.00 0.00 0.00 0.33 102.53 86.79 2.30 2.66 0.08 0.106 2 62.35 23.080 2 153.40 36.932 2 0.00 0.000 2 0.17 0.233 2 94.66 11.130 2 2.48 0.255 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 0.02 0.03 95.89 95.19 182.57 116.98 0.00 0.00 0.85 0.00 127.50 94.51 4.40 2.64 0.03 0.007 2 95.54 0.495 2 149.78 46.379 2 0.00 0.000 2 0.43 0.601 2 111.01 23.327 2 3.52 1.245 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL -------- 3.87 4.09 3.98 0.156 2 1.16 1.37 1.27 0.148 2 3.24 3.34 3.29 0.071 2 0.99 1.04 1.02 0.035 2 4.41 4.04 4.23 0.262 2 1.38 1.08 1.23 0.212 2 948 Appendix 6 Summary and Individual Blood Hormone Determination Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- THYROID STIMULATING U/mL ----------- TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- Group: Male 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 56.87 50.92 2.87 2.98 31.48 22.18 71.33 39.48 0.00 0.00 0.00 0.01 142.33 173.51 4.92 5.87 MEAN S.D. N 53.90 4.207 2 2.93 0.078 2 26.83 6.576 2 55.41 22.521 2 0.00 0.000 2 0.01 0.007 2 157.92 22.048 2 5.40 0.672 2 Group: Male 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 35.11 69.91 5.86 3.19 27.97 21.80 33.61 59.64 0.00 0.00 0.15 0.00 141.33 136.42 4.17 4.73 MEAN S.D. N 52.51 24.607 2 4.53 1.888 2 24.89 4.363 2 46.63 18.406 2 0.00 0.000 2 0.08 0.106 2 138.88 3.472 2 4.45 0.396 2 Group: Male 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 53.56 42.27 2.07 1.98 12.59 22.13 50.72 61.86 0.00 0.00 0.00 0.00 189.73 142.92 6.84 6.13 MEAN S.D. N 47.92 7.983 2 2.03 0.064 2 17.36 6.746 2 56.29 7.877 2 0.00 0.000 2 0.00 0.000 2 166.33 33.100 2 6.49 0.502 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL -------- 3.54 3.31 3.43 0.163 2 1.36 1.43 1.40 0.049 2 3.71 3.76 3.74 0.035 2 1.35 1.21 1.28 0.099 2 3.92 3.06 3.49 0.608 2 1.07 1.07 1.07 0.000 2 949 ANIMAL NUMBER ------ CORTISOL g/dL -------- Group: Female 1 I05529 I05549 56.92 54.02 MEAN S.D. N 55.47 2.051 2 Group: Female 3 I05539 I05552 48.00 74.04 MEAN S.D. N 61.02 18.413 2 Group: Female 4 I05533 I05542 61.92 89.59 MEAN S.D. N 75.76 19.566 2 Appendix 6 Summary and Individual Blood Hormone Determination Day 364 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS TESTOSTERONE ng/mL ------------ ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- THYROID STIMULATING U/mL ----------- TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- Dose Level: 0 Dosage Unit: mg/kg/day 0.36 0.01 46.66 72.28 106.07 120.53 0.00 0.00 0.38 0.00 114.22 94.96 3.48 2.75 0.19 0.247 2 59.47 18.116 2 113.30 10.225 2 0.00 0.000 2 0.19 0.269 2 104.59 13.619 2 3.12 0.516 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 0.01 0.13 53.88 25.95 120.92 71.07 0.00 0.00 0.12 0.39 113.58 89.22 2.73 3.99 0.07 0.085 2 39.92 19.749 2 96.00 35.249 2 0.00 0.000 2 0.26 0.191 2 101.40 17.225 2 3.36 0.891 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 0.13 0.07 166.75 164.57 352.52 175.61 0.00 0.00 0.28 0.00 108.62 105.87 3.84 3.34 0.10 0.042 2 165.66 1.541 2 264.07 125.094 2 0.00 0.000 2 0.14 0.198 2 107.25 1.945 2 3.59 0.354 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL -------- 3.48 3.89 3.69 0.290 2 1.17 1.40 1.29 0.163 2 3.40 3.06 3.23 0.240 2 1.10 1.03 1.07 0.049 2 3.20 3.31 3.26 0.078 2 1.15 1.07 1.11 0.057 2 950 Appendix 6 Summary and Individual Blood Hormone Determination Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- THYROID STIMULATING U/mL ----------- TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- Group: Male 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 45.28 42.55 3.12 2.03 24.62 20.60 33.29 17.89 0.00 0.00 4.00 3.18 160.85 158.81 7.90 7.34 MEAN S.D. N 43.92 1.930 2 2.58 0.771 2 22.61 2.843 2 25.59 10.889 2 0.00 0.000 2 3.59 0.580 2 159.83 1.442 2 7.62 0.396 2 Group: Male 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05505 I05523 35.05 58.45 5.77 4.15 33.45 34.94 15.52 31.76 0.00 0.00 3.02 2.40 156.75 189.99 5.12 8.58 MEAN S.D. N 46.75 16.546 2 4.96 1.146 2 34.20 1.054 2 23.64 11.483 2 0.00 0.000 2 2.71 0.438 2 173.37 23.504 2 6.85 2.447 2 Group: Male 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 34.37 18.72 2.19 5.27 15.15 32.89 34.29 47.87 0.00 0.00 2.70 2.67 200.22 142.75 8.55 6.89 MEAN S.D. N 26.55 11.066 2 3.73 2.178 2 24.02 12.544 2 41.08 9.603 2 0.00 0.000 2 2.69 0.021 2 171.49 40.637 2 7.72 1.174 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL -------- 5.07 3.03 4.05 1.442 2 2.53 1.83 2.18 0.495 2 4.10 4.63 4.37 0.375 2 1.85 2.07 1.96 0.156 2 3.56 4.05 3.81 0.346 2 1.51 1.83 1.67 0.226 2 951 ANIMAL NUMBER ------ CORTISOL g/dL -------- Group: Female 1 I05529 I05549 61.24 45.43 MEAN S.D. N 53.34 11.179 2 Group: Female 3 I05539 I05552 59.18 40.35 MEAN S.D. N 49.77 13.315 2 Group: Female 4 I05533 I05542 52.84 88.82 MEAN S.D. N 70.83 25.442 2 Appendix 6 Summary and Individual Blood Hormone Determination Day 456 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS TESTOSTERONE ng/mL ------------ ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- THYROID STIMULATING U/mL ----------- TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- Dose Level: 0 Dosage Unit: mg/kg/day 0.75 0.16 60.82 58.64 62.11 17.39 0.00 0.00 3.41 2.27 131.39 127.08 6.12 5.03 0.46 0.417 2 59.73 1.541 2 39.75 31.622 2 0.00 0.000 2 2.84 0.806 2 129.24 3.048 2 5.58 0.771 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 0.06 0.15 111.82 63.26 73.29 56.27 0.00 0.00 5.31 5.26 127.44 104.90 4.32 5.02 0.11 0.064 2 87.54 34.337 2 64.78 12.035 2 0.00 0.000 2 5.29 0.035 2 116.17 15.938 2 4.67 0.495 2 Dose Level: 0.75 Dosage Unit: mg/kg/day 0.73 0.30 101.24 180.10 86.37 115.95 0.00 0.00 5.20 4.19 140.68 147.41 4.86 4.23 0.52 0.304 2 140.67 55.762 2 101.16 20.916 2 0.00 0.000 2 4.70 0.714 2 144.05 4.759 2 4.55 0.445 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL -------- 4.81 4.72 4.77 0.064 2 2.15 2.27 2.21 0.085 2 3.48 3.31 3.40 0.120 2 1.46 1.10 1.28 0.255 2 3.55 3.15 3.35 0.283 2 1.56 1.11 1.34 0.318 2 952 Appendix 6 Summary and Individual Blood Hormone Determination Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ CORTISOL g/dL -------- TESTOSTERONE ng/mL ------------ ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- THYROID STIMULATING U/mL ----------- TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- Group: Male 1 Dose Level: 0 Dosage Unit: mg/kg/day I05520 I05526 41.44 48.80 3.51 2.29 19.03 21.13 35.81 22.20 0.00 0.00 3.01 3.34 141.17 144.88 5.57 5.51 MEAN 45.12 2.90 20.08 29.01 0.00 S.D. 5.204 0.863 1.485 9.624 0.000 N 2 2 2 2 2 Group: Male 3 Dose Level: 0.15 Dosage Unit: mg/kg/day 3.18 0.233 2 143.03 2.623 2 5.54 0.042 2 I05505 I05523 43.54 55.25 2.03 4.77 22.13 33.60 11.11 27.76 0.00 0.00 3.11 3.17 127.36 164.68 4.68 7.26 MEAN S.D. N 49.40 8.280 2 3.40 1.937 2 27.87 8.111 2 19.44 11.773 2 0.00 0.000 2 3.14 0.042 2 146.02 26.389 2 5.97 1.824 2 Group: Male 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05511 I05522 31.74 17.51 6.17 6.28 27.18 30.18 34.39 40.74 0.00 0.00 1.92 3.36 211.71 133.42 7.91 6.19 MEAN S.D. N 24.63 10.062 2 6.23 0.078 2 28.68 2.121 2 37.57 4.490 2 0.00 0.000 2 2.64 1.018 2 172.57 55.359 2 7.05 1.216 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL -------- 4.31 4.10 4.21 0.148 2 3.06 3.91 3.49 0.601 2 1.98 1.97 1.98 0.007 2 1.51 1.83 1.67 0.226 2 5.89 3.90 4.90 1.407 2 1.92 1.80 1.86 0.085 2 953 ANIMAL NUMBER ------ CORTISOL g/dL -------- Group: Female 1 I05529 I05549 61.95 50.10 MEAN S.D. N 56.03 8.379 2 Group: Female 3 I05539 I05552 58.68 26.08 MEAN S.D. N 42.38 23.052 2 Group: Female 4 I05533 I05542 49.05 82.98 MEAN S.D. N 66.02 23.992 2 Appendix 6 Summary and Individual Blood Hormone Determination Day 546 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS TESTOSTERONE ng/mL ------------ ESTRADIOL pg/mL --------- ESTRONE pg/mL ------- ESTRIOL pg/mL ------- THYROID STIMULATING U/mL ----------- TOTAL TRIIODOTHYRONINE ng/dL ---------------- FREE TRIIODOTHYRONINE pg/mL ---------------- Dose Level: 0 Dosage Unit: mg/kg/day 0.32 0.15 88.86 55.18 60.95 29.70 0.00 0.00 2.28 2.86 113.93 122.28 4.61 4.59 0.24 0.120 2 72.02 23.815 2 45.33 22.097 2 0.00 0.000 2 2.57 0.410 2 118.11 5.904 2 4.60 0.014 2 Dose Level: 0.15 Dosage Unit: mg/kg/day 0.22 0.18 249.40 228.31 112.37 104.83 0.00 0.00 4.32 2.22 133.88 194.67 QNS 7.69 0.20 0.028 2 238.86 14.913 2 108.60 5.332 2 0.00 0.000 2 3.27 1.485 2 164.28 42.985 2 7.69 1 Dose Level: 0.75 Dosage Unit: mg/kg/day 0.73 0.40 89.07 94.97 85.47 46.34 0.00 0.00 3.89 4.50 122.53 131.85 4.63 4.36 0.57 0.233 2 92.02 4.172 2 65.91 27.669 2 0.00 0.000 2 4.20 0.431 2 127.19 6.590 2 4.50 0.191 2 Covance 6329-223 3M T-6295.7 TOTAL THYROXIN g/dL -------- FREE THYROXIN ng/dL -------- 4.23 4.96 4.60 0.516 2 1.65 1.91 1.78 0.184 2 3.65 6.48 5.07 2.001 2 1.63 1.81 1.72 0.127 2 3.41 3.46 3.44 0.035 2 1.41 1.31 1.36 0.071 2 954 Appendix 6 Summary and Individual E2, FSH, and LH Additional Serum Analysis at Anilytics 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ E2 pg/mL --------- FSH ng/mL -------- LH ng/mL --------- Group: Male 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 I05527 0.00 9.89 MEAN S.D. N 4.95 6.993 2 Group: Male 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05514 I05515 I05516 I05521 17.02 0.49 1.53 47.01 MEAN S.D. N 16.51 21.691 4 Group: Male 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05510 I05518 I05524 I05528 6.62 3.35 0.76 3.24 MEAN S.D. N 3.49 2.404 4 Covance 6329-223 3M T-6295.7 955 Appendix 6 Summary and Individual E2, FSH, and LH Additional Serum Analysis at Anilytics 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ E2 pg/mL --------- FSH ng/mL -------- LH ng/mL --------- Group: Male 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05506 I05507 I05512 I05522a I05511a 0.00 0.00 0.00 18.68 12.85 MEAN S.D. N 6.31 8.877 5 a Recovery animal. Covance 6329-223 3M T-6295.7 956 Appendix 6 Summary and Individual E2, FSH, and LH Additional Serum Analysis at Anilytics 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ E2 pg/mL --------- FSH ng/mL -------- LH ng/mL --------- Group: Female 1 Dose Level: 0 Dosage Unit: mg/kg/day I05530 I05531 I05535 I05544 27.79 132.76 27.20 85.52 3.46 1.61 1.21 0.36 0.75 0.81 2.93 1.95 MEAN S.D. N 68.32 50.931 4 1.66 1.308 4 1.61 1.039 4 Group: Female 2 Dose Level: 0.03 Dosage Unit: mg/kg/day I05541 I05547 I05550 76.34 88.20 33.55 2.24 2.83 0.51 2.25 0.83 1.85 MEAN S.D. N 66.03 28.747 3 1.86 1.206 3 1.64 0.732 3 Group: Female 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 I05538 I05545 I05548 40.88 87.24 42.82 33.03 2.03 1.80 0.38 0.42 2.79 2.19 2.17 1.86 MEAN S.D. N 50.99 24.533 4 1.16 0.88 4 2.25 0.389 4 Covance 6329-223 3M T-6295.7 957 Appendix 6 Summary and Individual E2, FSH, and LH Additional Serum Analysis at Anilytics 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS ANIMAL NUMBER ------ E2 pg/mL --------- FSH ng/mL -------- LH ng/mL --------- Group: Female 4 Dose Level: 0.75 Dosage Unit: mg/kg/day I05534 I05536 I05540 I05551 I05542a I05533a 0.00 0.00 4.45 19.30 159.41 122.77 0.38 0.76 0.88 0.32 1.37 1.50 2.20 2.03 2.06 1.73 2.55 1.58 MEAN S.D. N 50.99 71.102 6 0.87 0.490 6 2.03 0.344 6 a Recovery animal. Covance 6329-223 3M T-6295.7 958 Appendix 6 Summary and Individual T3, T4, Free T4, TSH, and Estradiol Additional Serum Analysis at Mayo Clinic - Week 27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS T3 T4 Free T4 TSH ng/dL ug/dL ng/dL mIU/L Group: Male 1 Dose Level: 0 Dosage Unit: mg/kg/day I05508 160 3 1.4 0.24 I05527 132 3.5 1.5 0.86 Estradiol pg/mL <35 <35 Mean 146.0 3.3 SD 19.80 0.35 N 2 2 Group: Male 2 Dose Level: 0.03 I05514 154 3.6 I05515 135 3 I05516 166 4 I05521 126 4.1 1.5 0.6 NA 0.07 0.44 NA 2 2 NA Dosage Unit: mg/kg/day 1.5 0.48 <35 1.4 0.49 <35 1.8 0.7 <35 1.4 0.55 <35 Mean 151.7 3.5 SD 15.63 0.50 N 3 3 Group: Male 3 Dose Level: 0.15 I05510 123 3.2 I05524 128 2.9 I05528 133 2.8 1.6 0.6 NA 0.21 0.12 NA 3 3 NA Dosage Unit: mg/kg/day 1.3 1.5 <35 1.6 0.55 <35 NS NS <35 Mean SD N 128.0 3.0 1.5 1.0 NA 5.00 0.21 0.21 0.67 NA 3 3 2 2 NA NS Test cancelled. Quantity not sufficient. 959 Covance 6329-223 3M T-6295.7 Appendix 6 Summary and Individual T3, T4, Free T4, TSH, and Estradiol Additional Serum Analysis at Mayo Clinic - Week 27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS T3 T4 ng/dL ug/dL Group: Male 4 Dose Level: 0.75 I05506 94 5.6 I05507 81 3.3 I05512 53 2.4 Free T4 TSH Estradiol ng/dL mIU/L pg/mL Dosage Unit: mg/kg/day 1.6 1.7 <35 1.5 1.4 <35 1.4 1.2 <35 Mean 76.0 3.8 1.5 1.4 NA SD 20.95 1.65 0.10 0.25 NA N 3 3 3 3 NA Group: Female 1 Dose Level: 0 Dosage Unit: mg/kg/day I05530 176 4.7 1.8 0.69 <35 I05531 128 2.9 1.4 0.27 146 I05535 134 4.7 1.7 NS <35 I05544 154 2.8 1.2 2.1 83 Mean 148.0 3.8 SD 27.73 1.07 N 4 4 Group: Female 2 Dose Level: 0.03 I05541 140 4.4 I05547 150 4.4 I05550 124 3.3 1.5 1.0 114.5 0.28 0.96 44.55 4 3 2 Dosage Unit: mg/kg/day 2 0.52 73 1.6 0.7 48 1.5 1.1 <35 Mean SD N 138.0 13.11 3 4.0 0.64 3 1.7 0.26 3 0.8 0.30 3 60.5 17.68 2 NS Test cancelled. Quantity not sufficient. 960 Covance 6329-223 3M T-6295.7 Appendix 6 Summary and Individual T3, T4, Free T4, TSH, and Estradiol Additional Serum Analysis at Mayo Clinic - Week 27 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS T3 T4 Free T4 TSH Estradiol ng/dL ug/dL ng/dL mIU/L pg/mL Group: Female 3 Dose Level: 0.15 Dosage Unit: mg/kg/day I05532 100 3.5 1.4 3 <35 I05538 121 2.5 1.1 0.63 78 I05545 105 3.3 1.3 0.68 <35 I05548 137 3.6 1.6 0.99 <35 I05538 121 2.5 1.1 0.63 78 Mean 116.8 3.1 SD 14.70 0.54 N 5 5 Group: Female 4 Dose Level: 0.75 I05534 79 4.2 I05540 101 2.8 I05551 120 4 1.3 1.2 78.0 0.21 1.03 0.00 5 5 2 Dosage Unit: mg/kg/day 1.9 3.3 <35 1.3 1.5 <35 1.6 0.88 <35 Mean SD N 100.0 3.7 1.6 1.9 NA 20.52 0.76 0.30 1.26 NA 3 3 3 3 NA Covance 6329-223 3M T-6295.7 961 Appendix 6 Summary and Individual T3, T4, Free T4, TSH, and Estradiol Additional Serum Analysis at Mayo Clinic - Week 79 26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS T3 T4 ng/dL ug/dL Group: Male 4 Dose Level: 0.75 I05522 132 3 I05511 240 5.3 Free T4 TSH Estradiol ng/dL mIU/L pg/mL Dosage Unit: mg/kg/day 1.2 0.49 <35 1.3 0.035 <35 Mean 186.0 4.2 SD 76.37 1.63 N 2 2 Group: Female 4 Dose Level: 0.75 I05542 134 3.3 I05533 134 3.5 1.3 0.3 NA 0.07 0.32 NA 2 2 NA Dosage Unit: mg/kg/day 1.4 0.79 152 1.4 1.4 53 Mean SD N 134.0 0.00 2 3.4 0.14 2 1.4 0.00 2 1.1 0.43 2 102.5 70.00 2 Covance 6329-223 3M T-6295.7 962 APPENDIX 7 Cell Proliferation Report Covance 6329-223 3M T-6295.7 Note: This appendix contains information supplied and audited by Pathology Associates International (PAI). 963 Covance 6329-223 3M T-6295.7 964 Covance 6329-223 3M T-6295.7 965 Covance 6329-223 3M T-6295.7 966 Covance 6329-223 3M T-6295.7 967 Covance 6329-223 3M T-6295.7 968 Covance 6329-223 3M T-6295.7 969 Covance 6329-223 3M T-6295.7 970 Covance 6329-223 3M T-6295.7 971 Covance 6329-223 3M T-6295.7 972 Covance 6329-223 3M T-6295.7 973 Covance 6329-223 3M T-6295.7 974 Covance 6329-223 3M T-6295.7 975 Covance 6329-223 3M T-6295.7 976 Covance 6329-223 3M T-6295.7 APPENDIX 8 Electron Microscopic Evaluation of Liver in Cynomolgus Monkeys Note: This appendix contains information supplied and audited by Pathology Associates International (PAI). 977 Covance 6329-223 3M T-6295.7 978 Covance 6329-223 3M T-6295.7 979 Covance 6329-223 3M T-6295.7 980 Covance 6329-223 3M T-6295.7 981 Covance 6329-223 3M T-6295.7 982 Covance 6329-223 3M T-6295.7 983 Covance 6329-223 3M T-6295.7 984 Covance 6329-223 3M T-6295.7 985 Covance 6329-223 3M T-6295.7 986 Covance 6329-223 3M T-6295.7 987 Covance 6329-223 3M T-6295.7 988 Covance 6329-223 3M T-6295.7 989 Covance 6329-223 3M T-6295.7 990 Covance 6329-223 3M T-6295.7 991 Covance 6329-223 3M T-6295.7 992 Covance 6329-223 3M T-6295.7 993 Covance 6329-223 3M T-6295.7 994 Covance 6329-223 3M T-6295.7 995 Covance 6329-223 3M T-6295.7 996 Covance 6329-223 3M T-6295.7 997 Covance 6329-223 3M T-6295.7 998 Covance 6329-223 3M T-6295.7 999 Covance 6329-223 3M T-6295.7 1000 Covance 6329-223 3M T-6295.7 1001 Covance 6329-223 3M T-6295.7 1002 Covance 6329-223 3M T-6295.7 1003 Covance 6329-223 3M T-6295.7 1004 Covance 6329-223 3M T-6295.7 1005 Covance 6329-223 3M T-6295.7 1006 Covance 6329-223 3M T-6295.7 1007 Covance 6329-223 3M T-6295.7 1008 Covance 6329-223 3M T-6295.7 1009 Covance 6329-223 3M T-6295.7 1010 Covance 6329-223 3M T-6295.7 1011 Covance 6329-223 3M T-6295.7 1012 Covance 6329-223 3M T-6295.7 1013 Covance 6329-223 3M T-6295.7 1014 Covance 6329-223 3M T-6295.7 1015 Covance 6329-223 3M T-6295.7 1016 Covance 6329-223 3M T-6295.7 1017 Covance 6329-223 3M T-6295.7 1018 Covance 6329-223 3M T-6295.7 1019 Covance 6329-223 3M T-6295.7 1020 Covance 6329-223 3M T-6295.7 1021 Covance 6329-223 3M T-6295.7 1022 Covance 6329-223 3M T-6295.7 1023 Covance 6329-223 3M T-6295.7 1024 Covance 6329-223 3M T-6295.7 1025 Covance 6329-223 3M T-6295.7 1026 Covance 6329-223 3M T-6295.7 1027 Covance 6329-223 3M T-6295.7 1028 Covance 6329-223 3M T-6295.7 1029 Covance 6329-223 3M T-6295.7 1030 Covance 6329-223 3M T-6295.7 1031 Covance 6329-223 3M T-6295.7 1032 Covance 6329-223 3M T-6295.7 1033 Covance 6329-223 3M T-6295.7 1034 Covance 6329-223 3M T-6295.7 1035 Covance 6329-223 3M T-6295.7 1036 Covance 6329-223 3M T-6295.7 1037 Covance 6329-223 3M T-6295.7 1038 Covance 6329-223 3M T-6295.7 1039 Covance 6329-223 3M T-6295.7 1040 Covance 6329-223 3M T-6295.7 1041 Covance 6329-223 3M T-6295.7 1042 Covance 6329-223 3M T-6295.7 1043 Covance 6329-223 3M T-6295.7 1044 Covance 6329-223 3M T-6295.7 1045 Covance 6329-223 3M T-6295.7 1046 Covance 6329-223 3M T-6295.7 1047 Covance 6329-223 3M T-6295.7 1048 Covance 6329-223 3M T-6295.7 1049 Covance 6329-223 3M T-6295.7 1050 Covance 6329-223 3M T-6295.7 1051 Covance 6329-223 3M T-6295.7 1052 Covance 6329-223 3M T-6295.7 1053 Covance 6329-223 3M T-6295.7 1054 Covance 6329-223 3M T-6295.7 1055 Covance 6329-223 3M T-6295.7 1056 Covance 6329-223 3M T-6295.7 1057 Covance 6329-223 3M T-6295.7 1058 Covance 6329-223 3M T-6295.7 1059 Covance 6329-223 3M T-6295.7 1060 Covance 6329-223 3M T-6295.7 1061 Covance 6329-223 3M T-6295.7 1062 Covance 6329-223 3M T-6295.7 1063 Covance 6329-223 3M T-6295.7 1064 Covance 6329-223 3M T-6295.7 1065 Covance 6329-223 3M T-6295.7 1066 Covance 6329-223 3M T-6295.7 1067 Covance 6329-223 3M T-6295.7 1068 APPENDIX 9 Urobilinogen Analysis Report Covance 6329-223 3M T-6295.7 Note: The report in this appendix was supplied by the Sponsor, based on data supplied by the Mayo Clinic. The analysis at the Mayo Clinic was not done in compliance with Good Laboratory Practice Regulations and was not audited by a Quality Assurance Unit. 1069 Covance 6329-223 3M T-6295.7 1070 Covance 6329-223 3M T-6295.7 1071 APPENDIX 10 Dose Confirmation Analysis Report Compound Stability Report Analytical Laboratory Report Certificate of Analysis Quality Assurance Statement Covance 6329-223 3M T-6295.7 Note: This appendix contains information supplied and audited by the Sponsor. 1072 Covance 6329-223 3M T-6295.7 1073 Covance 6329-223 3M T-6295.7 1074 Covance 6329-223 3M T-6295.7 1075 Covance 6329-223 3M T-6295.7 1076 Covance 6329-223 3M T-6295.7 1077 Covance 6329-223 3M T-6295.7 1078 Covance 6329-223 3M T-6295.7 1079 Covance 6329-223 3M T-6295.7 1080 Covance 6329-223 3M T-6295.7 1081 Covance 6329-223 3M T-6295.7 1082 Covance 6329-223 3M T-6295.7 1083 Covance 6329-223 3M T-6295.7 1084 Covance 6329-223 3M T-6295.7 1085 Covance 6329-223 3M T-6295.7 1086