Document zQ10XOBZawXbmVmgo7b7QMr6m

C O V M > THE DEVELOPMENT SERVICES COMPANY Sponsor: 3M St. Paul, Minnesota FINAL REPORT Study Title: 4-Week Range-Finding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Author: Peter J. Thomford, PhD Study Completion Date: July 5, 2000 Performing Laboratory: Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Laboratory Study Identification : Covance 6329-224 Sponsor Project Identification: 3M T-6314.2 Page 1 o f 373 Covance 6329-224 3M T-6314.2 QUALITY ASSURANCE STATEMENT This report, with the exception o f Appendix 7, has been reviewed by the Quality Assurance Unit o f Covance Laboratories Inc., in accordance with the Food and Drug Administration (FDA) Good Laboratory Practice Regulations, 21 CFR 58. The data in Appendix 7 was generated by and is the responsibility o f Pathology Associates International. The following inspections were conducted and findings reported to the study director and study director management. Inspection Dates From To 06/04/98 06/04/98 07/13/98 07/13/98 09/16/98 09/25/98 10/01/98 10/09/98 10/19/98- 10/22/98 06/02/99 06/02/99 05/02/00 05/03/00 Phase Protocol Review Postlife Data Review Data Review Report Review Protocol Amendment Review Report Review Date Reported to Study Director and Study Director Management 06/04/98 07/13/98 09/25/98 10/09/98 10/22/98 06/02/99 05/03/00 filW -_ Representative Quality Assurance Unit Q S ' X U | 1DCO Date 2 Covance 6329-224 3M T-6314.2 STUDY IDENTIFICATION 4-W eek Range-Finding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Test Material N-Methyl Perfluorooctanesulfonamido Ethanol (MeFOSE, T-6314) Sponsor 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Study Monitor Andrew M. Seacat, PhD 3M Toxicology Services 651.575.3161 Alternate Study M onitor 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. P.O. Box 7545 Madison, Wisconsin 53707-7545 608.241.7207 Study Timetable Study Initiation Date In-Life Start Date In-Life End Date Study Completion Date June 8, 1998 June 12, 1998 July 13, 1998 July 5, 2000 . 3 Covance 6329-224 3M T-6314.2 KEY PERSONNEL 4-Week Range-Rnding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Study Director Study Toxicologist Study Coordinator Supervisor, Small Animal Toxicology Supervisor, Dose Formulation Supervisor, Chemistry/Tox Support Supervisor, Laboratory Animal Medicine Clinical Pathologist Supervisor, Clinical Pathology Anatomical Pathologist Supervisor, Anatomical Pathology Peter J. Thomford, PhD Thomas E. Ryan, BS Nii van Bruce-Konuah Nathan E. Snortum, BA, BT, ALAT Dixie Bushee, BS, LATG Brian Schoenike, BS Donna J. Clemons, DVM Diplomate, ACLAM Robert L. Hall, DVM, PhD Diplomate, ACVP (Clinical Pathology) Ronald Markevitch, BS, MT (ASCP) Richard Hamilton Bruner, DVM Diplomate, ACVP Pathology Associates International Deborah Pirkel, ALAT 4 Covance 6329-224 3M T-6314.2 CONTENTS Page A B S T R A C T .................................................................................................................................... 8 P U R P O S E .................................................. 10 REGULATORY COMPLIANCE............................................................................................. 10 TEST M ATERIAL AND VEHICLE........... ............................................................................10 Test M aterial............................................................................................................................ 10 V ehicle.......................................................................................................................................10 Reserve (Archive) Samples.................................................................................................... 11 D isposition................................................................................................................................11 TEST SY STEM ............................................................................. H Test Animal............................................................................................................................. 11 Identification............................................................................................................................. 11 Acclim ation.............................................................................................................................. 11 Housing and M aintenance...................................................................................................... 12 Justification.............................................................................................................................. 12 P R O C E D U R E S ............................ 12 Group Designations and Dietary Levels...............................................................................13 Dose Preparation................................................................... 13 Retention Sam ples................................................................................................................... 14 Dose Analyses.......................................................................................................................... 14 M ethod o f Administration.......................................................................................................15 Clinical O bservations.............................................................................................................. 16 Body W eights........................................................................................................................... 16 Food Consum ption......................................................................................... -...................... 16 Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination...............................16 Clinical Pathology.................................................................................................................... 16 N ecropsy................................................................................................................................... 12 Organ W eights..........................................................................................................................18 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation.....................18 Palmitoyl-CoA Oxidase Tissue Collection and Analyses................................................... 18 Liver PFOS Analyses.............................................................:............................................... 18 Tissue Preservation..................................................................................................................19 Statistical Analyses.......................................................... 20 RECORD R ET EN TIO N ............................................................................................................20 5 Covance 6329-224 3M T-6314.2 CONTENTS (Continued) Page RESU LTS.......................................:........................................................................................... 21 Dose Analyses.............................................. 21 Clinical Observations and Survival....................................................................................... 21 Body Weights and Body Weight Changes.......................................................................... 22 Food Consumption................................................................................................................. 22 Test Material Consumption....................................................................................................23 Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination..............................23 Clinical Pathology....................................................................................................................23 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation....................24 Liver PFOS Determination...................................................................................... ............. 24 Anatomical Pathology.............................................................................................................24 C O N C L U S IO N S .............................................................................................. 25 S I G N A T U R E S ............................................................................................................................. 2 6 R E F E R E N C E S .............................................................................................................................27 PATHOLOGY REPORT.......................................................................... 28 COMMENTS ON THE D A TA .................................................................................................33 CODES, ABBREVIATIONS, AND UNITS......... .................................................................35 General Codes and Abbreviations..........................................................................................36 Codes for Clinical Pathology..................................................................................................37 Abbreviations and Units for Clinical Hematology..............................................................40 Abbreviations and Units for Clinical Chem istry.................................................................42 Abbreviations and Units for Clinical Urinalysis...................................................................44 Codes for Anatomical Pathology................................................................... 45 TABLES * 1 Results o f Homogeneity Analyses (ppm )...................................................................... 47 2 Results o f Stability Analyses (ppm )............................................................................... 49 3 Results o f Dose Preparation Analyses (ppm )................................................................51 4 Summary of Clinical Observations...................................... 53 5 Summary of Body Weight Data (g )............................................................................... 54 6 Summary o f Body Weight Change Data ( g ) ............................................................... 58 7 Summary o f Food Consumption Data (g )..................................................................... 62 8 Summary o f Test Material Consumption Data (mg/kg/day)......................................66 9 Summary o f Clinical Hematology D ata..........................................................................68 10 Summary o f Clinical Chemistry D ata............................................................................. 72 11 Summary o f Clinical Urinalysis D a ta ............................................................................. 76 6 m: Covance 6329-224 3M T-6314.2 CONTENTS (Continued) Page TABLES 12 Summary o f Absolute Organ Weight Data (g )............................................................78 13 Summary o f Organ-to-Body Weight Percentages........................................................81 14 Summary o f Organ-to-Brain Weight Ratios.................................................................. 84 15 Incidence of Macroscopic Observations........................................................................87 16 Incidence of Microscopic Observations.........................................................................89 17 Incidence of Severity o f Selected Microscopic Observations..................................... 97 APPENDIX 1.................. 98 Protocol Deviations................................................................................................................ 99 Protocol................................................................................................................................... 1^0 Protocol Amendment No. 1 ............................................................................................... 117 APPENDIX 2 ............................................................................................................................. 123 Individual Animal Fate D ata..................... 124 Individual Clinical Observations.......................................................................................... 127 APPENDIX 3 ............................................................................................................................. 133 Individual Body Weight Data ( g ) ........................................................................................134 APPENDIX 4 ..............................................................................................................................138 Individual Food Consumption Data (g )..............................................................................139 Individual Test Material Consumption Data (mg/kg/day)................................................ 143 APPENDIX 5 ..................................................................................................... I 46 Individual Clinical Hematology D ata.................................................................................. 147 Individual Clinical Chemistry D a ta ................... ..........................-..................................... 159 Individual Clinical Urinalysis D ata................................................................ ....................167 APPENDIX 6 ............................................................................................................................. 179 Individual Absolute Organ Weight Data ( g ) ......................................................................180 Individual Organ-to-Body Weight Percentages................................................................. 192 Individual Organ-to-Brain Weight R atios..........................................................................204 Individual Animal Pathology D ata...................................................................................... 216 APPENDIX 7 ..............................................................................i.............................................359 Cell Proliferation R eport...................................................................................................... 360 7 ABSTRACT Covance 6329-224 3M T-6314.2 The purpose of this study was to assess the toxicity o f the test material, N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) when administered in the diet to rats for at least 4 weeks. Six groups o f Crl:CD(SD) IGS BR rats were exposed to N-MeFOSE in the diet for at least 4 weeks. Each group contained six males and six females. The dose levels were 0 (control group), 1,10,30,100, and 500 ppm. Food was provided ad libitum , except when animals were fasted. W ater was provided ad libitum . The animals were observed twice daily (a.m. and p.m.) for mortality and moribundity. At least once each week, each animal was removed from its cage and examined for abnormalities and signs o f toxicity. Body weights and food consumption data were collected twice weekly for at least 4 weeks. Blood and urine samples were collected for hematology, clinical chemistry, and urinalysis tests from all surviving animals after 4 weeks o f treatment. After at least 4 weeks o f treatment, blood was also collected from all surviving animals for serum perfluorooctane sulfonic acid (PFOS) analyses. On Day 32, the animals were anesthetized, weighed, exsanguinated, and necropsied. At necropsy, macroscopic observations were recorded, selected organs were weighed, and selected tissues were collected and preserved. Samples o f liver were collected from all surviving animals for palmitoyl-CoA oxidase activity (by Covance) and proliferation cell nuclear antigen (PCNA) evaluation and liver PFOS analysis (by the Sponsor). The animal that died on test was also necropsied, but organ weights were not recorded. Microscopic examinations were done on tissues from each animal. One animal given 500 ppm N-MeFOSE died on Day 25. All other animals survived to the scheduled sacrifice. No clinical observations were noted that were considered to represent primary effects o f the test material. Lower body weight, body weight gains, and food consumption in animals given 500 ppm were test material-related. Dietary administration of N-MeFOSE at a dose level of 500 ppm for approximately 4 weeks was associated with several effects on clinical pathology test results including moderately lower red blood cell count, hemoglobin, and hematocrit; lower absolute eosinophil count; mildly higher urea nitrogen; moderately higher albumin and mildly to 8 Covance 6329-224 3M T-6314.2 moderately lower globulin; markedly lower cholesterol; mildly to moderately higher total bilirubin, aspartate aminotransferase, and alanine aminotransferase; and moderately higher hepatic palmitoyl-CoA oxidase. O f uncertain relationship to administration of N-MeFOSE were lower urine pH for males fed 500 ppm and small differences for animals fed 100 ppm including higher urea nitrogen, albumin, and alanine aminotransferase (males only) and lower cholesterol. O f the differences for animals fed 100 ppm, only the difference for alanine aminotransferase was statistically significant. Mean absolute and relative (to brain and body) liver weights for all males and females given 100 and 500 ppm N-MeFOSE were significantly increased over control values, and these variations were regarded as treatment-related. All additional mean organ weights, which varied significantly from control values, were considered to be within the range or normal biologic variation, or were manifestations of slight weight loss associated with physiologic stress. Treatment-related microscopic findings were restricted to the liver and consisted o f minimal to severe centrilobular hepatocellular hypertrophy. Hypertrophic changes were slightly more severe in males; and at the high-dose level, liver cell swelling in several males was associated with acute necrosis. Necrosis was attributed to restricted blood supply (ischemia) from swollen liver cells rather than direct hepatocellular damage. Additional microscopic findings were consistent with common, spontaneous alterations in laboratory rats or changes associated with stress, nutritional deprivation, or tissue processing artifact. Based on the results o f this study, dietary administration o f N-MeFOSE to Crl:CD(SD) IGS BR rats for at least 4 weeks resulted in adverse effects at a dose level of 500 ppm. The no-observable-adverse-effect level was determined to be 100 ppm. 9 PURPOSE Covance 6329-224 _____3M T-6314.2 The purpose o f this study was to assess the toxicity o f the test material, N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) when administered in the diet to rats for at least 4 weeks. REGULATORY COMPLIANCE The study was conducted in compliance with the Food and Drug Administration Good Laboratory Practice Regulations as set forth in Title 21 o f the US Code o f Federal Regulations, Part 58, issued December 22, 1978 (effective June 20, 1979), and with any applicable amendments. TEST MATERIAL AND VEHICLE Test Material The test material, N-Methyl Perfluorooctanesulfonamido Ethanol (MeFOSE, T-6314), Lot No. F-l 1364, is an off white powder. It was received at Covance on August 3, 1995. Information on synthesis methods, stability, purity, composition, or other characteristics that define the test material is on file with the Sponsor. The test material was stored at room temperature. Vehicle The vehicle was acetone (Spectrum Quality Products Inc., Gardena, California), Lot No. LH0253 (expiration date: June 2000). It was received at Covance on June 23, 1997. The vehicle was stored at room temperature. Information on synthesis methods, stability, purity, composition, or other characteristics that define the acetone is on file with the manufacturer. Covance 6329-224 3M T-6314.2 Reserve (Archive) Samples A reserve sample {approximately 5 g) of the test material was taken and stored at room temperature. These samples will be transferred to the Sponsor after authorization from the Sponsor. Disposition Remaining test material was retained for future use (see Protocol Deviations page for exception). TEST SYSTEM Test Animal Male and female Crl:CD(SD) IGS BR rats were obtained from the Raleigh, North Carolina, facility o f Charles River Laboratories, Inc., on June 2, 1998. The animals were 31 to 37 days old at initiation o f treatment. The males weighed from 144 to 194 g, and the females weighed from 114 to 158 g at initiation o f treatment. Identification Each animal was assigned a temporary number upon arrival Before initiation of treatment, a microchip identification device was implanted into each animal. After randomization for placement on test, each animal was assigned a permanent number, and the microchip was coded with the permanent number. All data for an animal are recorded under these numbers. Acclimation Forty-one males and 41 females were received on June 2, 1998, and acclimated in Animal Room 349 for 10 days before initiation o f treatment. In general, animals in this shipment appeared healthy. During acclimation, the animals were examined for abnormalities indicative o f health problems, and body weights were recorded for all animals at randomization. 11 Covance 6329-224 3M T-6314.2 Housing and Maintenance Animal Room 349 was used for this study. Environmental controls for the animal room were set to maintain 18 to 26 C, a relative humidity o f 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 o f the study. The animals were housed individually (except for the first 7 days o f acclimation when animals were group-housed) in stainless steel, screen-bottom cages. Certified rodent diet #5002 meal, (PMI Nutrition International) was provided ad libitum , except when animals were fasted. The diet is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. The results are on file with Covance-Madison. W ater was provided ad libitum. Samples o f 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. Animals not selected for the study (five males and five females) were removed from the study room and used for training procedures. Justification Rats historically have been used in safety evaluation studies and are recommended by appropriate regulatory agencies. PROCEDURES This study was conducted in accordance with the Protocol dated June 8, 1998, and Protocol Amendment No. 1. The protocol, protocol amendment, and protocol deviations are in Appendix 1. 12 Covance 6329-224 3M T-6314.2 The animals were examined by a laboratory animal veterinarian on June 10,1998, and found to be suitable for study consideration. Selection o f animals for the study was based on clinical observations, body weights, and other data as appropriate. Animals were assigned to treatment groups using a computerized blocking procedure designed to achieve body weight balance with respect to treatment group. At the time of randomization, the weight variation o f the animals for each sex used did not exceed 2 standard deviations o f the mean weight. Group mean body weights were analyzed using Levene's test for homogeneity of variance at the 5.0% probability level and found to be homogeneous. Animals were assigned to the study according to the following design: G roup Designations and D ietary Levels Number o f Animals Dietary Levels Group Male Female (ppm MeFOS)3 1 (Control)b 2 (Low) 66 66 0 1 3 (Low-Mid) 6 6 10 4 (Mid) 66 30 5 (Mid-High) 6 6 100 6 (High) 66 500 a Dose levels were expressed as ppm o f MeFOS. b The control animals received the basal diet only. Dose Preparation Dietary concentrations were based on the test material as supplied. Diets were prepared pretest for homogeneity, and twice for use in the in-life phase. P reparation o f D iet for G ro u p 1. The appropriate amount o f diet was weighed into a labeled container, and acetone was added at the same concentration as the high-dose concentration. The combination o f the diet and acetone was then mixed for 15 minutes. P rep aratio n o f D iet for G ro u p 6. Each dose level was prepared independently. A specified amount o f diet was weighed into a labeled Hobart mixing bowl. The required amount of test material was weighed and transferred into a labeled container. Approximately 5 mL o f acetone was added to the container and mixed manually. 13 Covance 6329-224 ____ 3MT-6314.2 Increments o f approximately 5 mL acetone were added as necessary until the test material had dissolved. To prepare a premix, the diet was transferred into a labeled Hobart mixing bowl. The test material and acetone were added to the mixing bowl, overlaid with a portion o f diet from the mixing bowl, and thoroughly mixed. A portion o f diet from the mixing bowl was transferred to a second mixing bowl, mixed manually to recover residual test material, and returned to the first mixing bowl. The contents o f the mixing bowl were thoroughly mixed. P rep aratio n of Diets for G roups 2 through 5. Each dose level was prepared independently. A specified amount o f diet was weighed into a labeled Hobart mixing bowl and a specified amount o f diet for Group 6 was weighed for each diet. A pocket was formed in the feed in the mixing bowl and the amount o f diet for Group 6 was transferred to the pocket. The contents o f the mixing bowl were thoroughly mixed for 10 minutes. Samples for dose analyses were taken directly from the mixing bowL The prepared test diets were stored at room temperature in covered containers until dispensed into feeding jars. Retention Samples Samples (approximately 100 g) were taken from each dose preparation sampled for dose analyses and stored at room temperature. These samples were discarded on December 9,1998 (see Protocol Deviations page for exception). Dose Analyses Analyses for the concentration o f test material in the dose preparations were done by Covance using an analytical method, MP-M324-MA, supplied by the Sponsor and validated by Covance. Homogeneity was determined for all test material dose preparations once pretest. One sample each (approximately 100 g) from the top, middle, and bottom of the dose preparations mixed for homogeneity analyses was collected, divided into three subsamples for extraction and analyzed for test material content. All samples were stored at room 14 Covance 6329-224 3M T-6314.2 temperature until analyzed. In addition, one sample each (approximately 100 g) from the top, middle, and bottom o f the 1-ppm dose preparation mixed for the in-life portion o f the study was collected, divided into three subsamples for extraction and analysis, and analyzed for test material content. To evaluate the stability o f the test material in the diet, four sets o f samples (approximately 100 g each) were taken from the highest test material concentration used for the study. One set was analyzed on the day o f mixing; a second sample o f the high-dose preparation was stored at room temperature for at least 19 days, then analyzed. The third sample o f the high-dose preparation was stored at room temperature for 32 days, then analyzed. Another sample o f the high-dose preparation was stored at room temperature for 62 days, then analyzed. The remaining sample o f the high-dose preparation was stored in a freezer set to maintain -10 to -30C for 8 weeks, then analyzed. In addition, three samples (approximately 100 g each) were taken from the low-dose level preparation mixed for the in-life portion o f the study and analyzed. Homogeneity samples collected from the middle of the low-dose preparation were analyzed on the day of mixing and used as the baseline value. Samples (approximately 100 g) from all dose preparations were analyzed. The homogeneity sample collected from the middle o f the low-dose level preparation mixed for Weeks 1 through 4 was used for dose confirmation. All samples were stored at room temperature until analyzed. Method of Administration Dietary admixture was used because the potential route of exposure in humans is oral. The dose preparations were administered ad libitum for at least 4 weeks, unless otherwise specified. 15 Covane* 6329-224 3M T-6314.2 Clinical Observations The animals were observed twice daily (a.m. and p.m.) for mortality and moribundity. Signs o f poor health or abnormal behavior were recorded as they were observed. At least once each week, each animal was removed from its cage and examined. Any unusual or abnormal findings were recorded. Body Weights Individual body weight data were recorded on the first day of treatment and twice weekly thereafter. Food Consumption Individual food consumption data were recorded twice weekly during treatment. Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination After at least 4 weeks o f treatment, animals were fasted overnight, anesthetized with carbon dioxide, and blood (as much as possible) was collected via cardiac puncture from all surviving animals. All samples were collected without anticoagulant, allowed to clot, at room temperature and centrifuged. Serum was harvested and stored in a freezer set to maintain -60 to -80C until packed on dry ice and shipped to the Sponsor for analyses. The samples were analyzed for PFOS. Results o f analyses will be reported separately by the Sponsor. Clinical Pathology After at least 4 weeks of treatment, blood and urine samples were collected from each animal. Animals were fasted overnight, and urine was collected chilled (approximately 16 hours before blood sampling); water was provided ad libitum . The animals were anesthetized with carbon dioxide; blood was collected via cardiac puncture. Potassium EDTA was used as anticoagulant for hematology tests. Animals were bled in random order. The following were evaluated. 16 Covance 6329-224 3M T-6314.2 H em atology red blood cell (erythrocyte) count hemoglobin hematocrit mean corpuscular volume mean corpuscular hemoglobin mean corpuscular hemoglobin concentration platelet count white blood cell (leukocyte) count differential blood cell count segmented neutrophil count lymphocyte count monocyte count . eosinophil count basophil count Reticulocyte count smears were made and held for possible future examination. glucose urea nitrogen creatinine total protein albumin globulin cholesterol total bilirubin Clinical Chemistry alanine aminotransferase gamma glutamyltransferase aspartate aminotransferase calcium inorganic phosphorus sodium potassium chloride appearance volume specific gravity pH protein urobilinogen Urinalysis glucose ketones bilirubin blood microscopic examination of sediment The remaining urine (up to 10 mL) for each animal was stored in a freezer set to maintain -1 0 to -3 0 C . Samples were packed on dry ice and shipped to the Sponsor. Urine samples will be stored by the Sponsor for possible future analysis. Necropsy A necropsy was done on the animal that was found dead. After at least 4 weeks o f treatment, all surviving animals were fasted overnight, anesthetized with carbon dioxide, bled for clinical pathology tests and serum PFOS samples, weighed, exsanguinated, and necropsied. Animals were necropsied in random order. 17 Covance 6329-224 3M T-6314.2 The necropsy included a macroscopic examination of the external features o f the carcass; all external body orifices; the abdominal, thoracic, and cranial cavities; organs; and tissues. Organ Weights At the scheduled sacrifice, the following organs (when present) were weighed; paired organs were weighed together (see Protocol Deviations for exception): adrenal (2) brain epididymis (2) kidney (2) liver ovary (2) spleen testis (2) thymus thyroid (2) with parathyroid Organ-to-body weight percentages and organ-to-brain weight ratios were calculated. Cell Proliferation Tissue Collection and Immunohistochemical Evaluation At the scheduled sacrifice, representative samples o f left lateral lobe o f the liver were collected from each animal and preserved in zinc formalin. After fixation, samples were embedded in paraffin and shipped to Pathology Associates International for proliferation cell nuclear antigen (PCNA) evaluatioa Results of the evaluation are in Appendix 7. Palmitoyl-CoA Oxidase Tissue Collection and Analyses At the scheduled sacrifice, a sample (approximately 500 mg) o f the right lateral lobe o f liver was collected from each animal, flash-frozen in liquid nitrogen, and stored in a freezer set to maintain -60 to -80C until analyzed for palmitoyl-CoA oxidase activity. Liver PFOS Analyses A portion o f the liver was collected from each animal at the scheduled sacrifice and stored in a freezer set to maintain -60 to -80C until packed on dry ice and shipped to the Sponsor for PFOS and metabolites analyses. Results o f these analyses will be reported separately by the Sponsor. Covance 6329-224 3M T-6314.2 Tissue Preservation The following tissues (when present) from each animal were collected and preserved in 10% neutral-buffered formalin: adrenal (2) aorta brain cecum cervix colon duodenum esophagus epididymis (2) eye (2) femur with bone marrow (articular surface o f the distal end) Harderian gland heart ileum with Peyer's patch (lymphoid aggregate) jejunum kidney (2) lesions liver lung with mainstem bronchi lymph nodes (mesenteric and mandibular) mammary glands (females only) ovary (2) pancreas pituitary prostate rectum salivary gland [mandibular (2)] sciatic nerve seminal vesicles skeletal muscle (thigh) skin spinal cord (cervical, mid-thoracic, and lumbar) spleen sternum with bone marrow stomach testis [(2) preserved in Bouin's fixative] thymus thyroid (2) with parathyroid trachea urinary bladder uterus vagina Zymbal's gland Tissues were shipped to Pathology Associates International for processing. The adrenals, brain, eyes, kidneys, liver, mesenteric lymph node, pancreas, spleen, testes, and ovaries from each animal were embedded in paraffin, sectioned, and stained with hematoxylin and eosin (see Protocol Deviations). The tissue slides were examined microscopically by Dr. Richard H. Bruner, DVM, DAVCP of Pathology Associates International Bone marrow smears from the femur of each animal at the scheduled sacrifice were prepared, stained with Wright's stain, and retained for possible examination. 19 Covance 6329-224 3M T-6314.2 Statistical Analyses Levene's test was done to test for variance homogeneity. In the case o f heterogeneity o f variance at p * 0.05, transformations were used to stabilize the variance. Comparison tests took variance heterogeneity into consideration. One-way analysis o f variance (ANOVA) was used (if applicable) to analyze body weights, body weight changes, food consumption, continuous clinical pathology values, and organ weight data. If the ANOVA was significant, Dunnett's t-test was used for control versus treated group comparisons. Group comparisons (Groups 2 through 6 versus Group 1) were evaluated at the 5.0%, two-tailed probability level. Only data collected on or after the first day of treatment was analyzed statistically. RECORD RETENTION All raw data, documentation, records, protocol, and specimens generated as a result o f this study will be archived in the storage facilities o f Covance-Madison for a period o f 1 year. One year after the submission o f the final report, the Sponsor will determine the final disposition o f the materials. All raw data stored on magnetic media, the protocol and protocol amendments, study correspondence, and an original copy o f the final report will be retained by Covance-Madison. PCNA evaluation data, paraffin blocks, and tissue slides will be retained by Pathology Associates International. Liver, urine, and serum samples sent to the Sponsor and analysis data will be retained by the Sponsor. 20 RESULTS Covance 6329-224 3M T-6314.2 Dose Analyses Results o f the homogeneity, stability, and dose preparation analyses are in Tables 1 through 3. Mean values o f the homogeneity analyses ranged from 102-268%, 95.9-102%, 93.7-97.0%, 94.4-95.8%, and 94.0-101% o f the theoretical concentrations for the diets containing 1,10, 30,100, and 500 ppmN-MeFOSE, respectively. Because the results of the analyses o f diets mixed on June 11, 1998, for the diet containing 1 ppm were high (118%, 268%, and 129%), they were reanalyzed. The results of the reanalyses were 116%, 114%, and 102%. These results indicate that the mixing procedure produced a homogeneous distribution o f the test material in the dose preparations. Results o f stability analyses of samples stored for 19, 32, and 62 days at room temperature and 8 weeks under frozen conditions, indicated that the mean concentrations were 90.2%, 83.4%, 70.6% and 97.2%, respectively, of the theoretical concentrations of 500 ppm. Results o f stability analyses o f samples from the 1-ppm theoretical concentration, indicated that the mean concentrations were 132% and 72.6% for the diet preparations, mixed pretest and the in-life portion o f the study, respectively. Therefore, the dose preparations were stable for 62 days at room temperature storage and 8 weeks under frozen conditions for mean concentration of 500 and 1 ppm, respectively. The mean concentrations of the dose preparation analyses for all levels ranged from 63.3% to 114% o f the theoretical concentrations. These data indicate that the levels o f N-methyl perfluorooctanesulfonamido ethanol (N-MeFOSE, T-6314) in the dose preparations were acceptable only for dose levels o f 10, 30 100, and 500 ppm. Clinical Observations and Survival Clinical observations are summarized in Table 4; individual data are in Appendix 2. Individual animal fate data are also in Appendix 2. 21 Covance 6329-224 _____3 M T -6314.2 One animal given 500 ppm N-MeFOSE died on Day 25. This animal exhibited severe hepatocellular hypertrophy and moderately-severe liver necrosis at microscopic exam. All other animals survived to the scheduled sacrifice. No clinical observations were noted that were considered effects o f the test material. Body Weights and Body Weight Changes Body weight and body weight change data are summarized in Tables 5 and 6; individual data are in Appendix 3. Although not statistically significant, animals given 1,10, 30, or 100 ppm N-MeFOSE had lower mean body weights than those o f controls for most o f the study. Test material related lower body weight and body weight gains were noted for animals given 500 ppm. For males and females given 500 ppm, statistically lower body weights were apparent beginning on Days 8 and 11, respectively, and continuing through the end o f study. Mean body weight gains for animals given 500 ppm were lower than those o f control animals throughout the study. Food Consumption Food consumption data are summarized in Table 7; individual data are in Appendix 4. Statistically test material related decreases in food consumption were noted in males given 500 ppm throughout the study and in females given 500 ppm beginning on Day 4 and continuing throughout the study. The overall mean food consumption for males fed the 100- or 500-ppm concentration was significantly reduced compared with that o f the controls, and the overall mean food consumption for females fed the 500-ppm concentration was significantly reduced compared with that o f the controls. There were no significant food consumption differences noted in animals given 1, 10 or 30 ppm N-MeFOSE. Covance 6329-224 3M T-6314.2 Test Material Consumption Test material consultation data are summarized in Table 8. Individual data are in Appendix 4. Animals were fed diets containing 1,10, 30, 100, or 500 ppm N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314). The mean amounts of test material consumed by the animals in these groups were 0.087 to 0.140 mg/kg/day; 0.816 to 1.325 mg/kg/day; 2.432 to 4.030 mg/kg/day; 7.768 to 13.192 mg/kg/day; and 35.168 to 62.612 mg/kg/day for males, respectively. Values for females were 0.096 to 0.147 mg/kg/day; 0.848 to 1.399 mg/kg/day; 2.612 to 4.124 mg/kg/day; 8.485 to 13.802; and 38.527 to 62.217, respectively. The overall test material consumption ranged from 0.105 to 44.590 mg/kg/day for the males and 0.111 to 45.050 mg/kg/day for the females. Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination Results o f serum PFOS level determination will be reported separately by the Sponsor. Clinical Pathology Hematology, coagulation, clinical chemistry and urinalysis data are summarized in Tables 9 through 11; individual data are in Appendix 5. The Pathology Report contains a discussion o f the data. Dietary administration of N-MeFOSE at a dose level of 500 ppm for approximately 4 weeks was associated with several effects on clinical pathology test results including moderately lower red blood cell count, hemoglobin, and hematocrit; lower absolute eosinophil count; mildly higher urea nitrogen; moderately higher albumin and mildly to moderately lower globulin; markedly lower cholesterol; mildly to moderately higher total bilirubin, aspartate aminotransferase, and alanine aminotransferase; and moderately higher hepatic palmitoyl-CoA oxidase. O f uncertain relationship to administration of N-MeFOSE were lower urine pH for males fed 500 ppm and small differences for animals fed 100 ppm including higher urea nitrogen, albumin, and alanine aminotransferase (males only) and lower cholesterol. O f the differences for animals fed 100 ppm, only the difference for alanine aminotransferase was statistically significant. 23 Covance 6329-224 _____3M T-6314.2 Cell Proliferation Tissue Collection and Inununohistochemical Evaluation Results o f cell proliferation and immunohistochemical evaluation provided by Pathology Associates International are in Appendix 7. Results o f the cell proliferation evaluation will be provided by Pathology Associates International. Liver PFOS Determination Results o f liver PFOS level determination will be reported separately by the Sponsor. Anatomical Pathology Terminal body weights, absolute organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios are summarized in Tables 12 through 14; incidences o f macroscopic and microscopic observations are summarized in Tables 15 and 16; the incidence o f severity o f microscopic observations is summarized in Table 17. Individual data are in Appendix 6. The Pathology Report contains a discussion o f the data. Mean absolute and relative (to brain and body) liver weights for all males and females given 100 and 500 ppm N-MeFOSE were significantly increased over control values, and these variations were regarded as treatment-related. All additional mean organ weights, which varied significantly from control values, were considered to be within the range or normal biologic variation, or were manifestations o f slight weight loss associated with physiologic stress. Treatment-related microscopic findings were restricted to the liver and consisted o f minimal to severe centrilobular hepatocellular hypertrophy. Hypertrophic changes were slightly more severe in males; and at the high-dose level, liver cell swelling in several males was associated with acute necrosis. Necrosis was attributed to restricted blood supply (ischemia) from swollen liver cells rather than direct hepatocellular damage. Additional microscopic findings were consistent with common, spontaneous alterations in laboratory rats or changes associated with stress, nutritional deprivation, or tissue processing artifact. CONCLUSIONS Covance 6329-224 3M T-6314.2 Based on the results o f this study, dietary administration of N-MeFOSE, T-6314 to Crl:CD(SD) IGS BR rats for at least 4 weeks resulted in adverse effects at a dose level o f 500 ppm. The no-observable-adverse-effect level was determined to be 100 ppm. 25 SIGNATURES Nii van Bruce-Konuah Study Coordinator Covance Laboratories Inc. Covance 6329-224 3M T-6314.2 26 Covance 6329-224 3M T-6314.2 REFERENCES Dunnett, C. W., "New Tables for Multiple Comparisons with a Control," Biometrics, 20:482-491 (1964). Levene, H., "Robust Tests for Equality o f 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 Principlesjn Experimental Design. Second Ed., Ch. 3, pp. 149-260, McGraw-Hill: New York, New York (1971a). Winer, B. J., "Analysis o f Covariance," Statistical Principles in Experimental Design, Second Ed., Ch. 10, pp. 752-812, McGraw-Hill: New York, New York (1971b). 27 PATHOLOGY REPORT Covance 6329-224 3M T-6314.2 SUMMARY The purpose o f this study was to assess the toxicity o f the test material, N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) when administered in the diet to rats for at least 4 weeks. The test material was administered at dose levels o f 1 ,1 0 ,3 0 , 100, and 500 ppm. Dietary administration of N-MeFOSE at a dose level o f 500 ppm for approximately 4 weeks was associated with several effects on clinical pathology test results including moderately lower red blood cell count, hemoglobin, and hematocrit; lower absolute eosinophil count; mildly higher urea nitrogen; moderately higher albumin and mildly to moderately lower globulin; markedly lower cholesterol; mildly to moderately higher total bilirubin, aspartate aminotransferase, and alanine aminotransferase; and moderately higher hepatic palmitoyl-CoA oxidase. O f uncertain relationship to administration o f N-MeFOSE were lower urine pH for males fed 500 ppm and small differences for animals fed 100 ppm including higher urea nitrogen, albumin, and alanine aminotransferase (males only) and lower cholesterol O f the differences for animals fed 100 ppm, only the difference for alanine aminotransferase was statistically significant. Treatment-related microscopic findings were restricted to the liver and consisted o f minimal to severe centrilobular hepatocellular hypertrophy. Hypertrophic changes were slightly more severe in males; and at the high-dose level liver cell swelling in several males was associated with acute necrosis. Necrosis was attributed to restricted blood supply (ischemia) from swollen liver cells rather than direct hepatocellular damage. Additional microscopic findings were consistent with common, spontaneous alterations in laboratory rats or changes associated with stress, nutritional deprivation, or tissue processing artifact. 28 METHODS Covance 6329-224 3M T-6314.2 Six groups o f Crl:CD(SD) IGS BR rats (six animals/sex/group) were fed diets containing the test material at a dose level of 0 (control group; fed basal diet only), 1,10, 30,100, or 500 ppm. Before the schedule sacrifice and necropsy during Week 5, blood and urine were collected for hematology, clinical chemistry, and urinalysis tests. At necropsy, macroscopic observations were recorded, organ weights were obtained, and tissues were placed in fixative as specified by the protocol. In addition, samples of liver were collected for evaluation o f hepatocellular proliferation (by Pathology Associates International), determination o f hepatic palmitoyl-CoA oxidase activity (by Covance), and analysis for PFOS and metabolites (by the Sponsor). The animal that died on test was also necropsied, but organ weights and liver samples for the special analyses were not obtained. Microscopic examinations were done on the following tissues from each animal: adrenals, brain, eyes, kidneys, liver, mesenteric lymph node, pancreas, spleen, testes, ovaries, and lesions. Statistically significant differences cited in the Results and Discussion section are based on comparisons between the control and treated groups. RESULTS AND DISCUSSION Mortality Animal No. C94523 given 500 ppm N-MeFOSE died on Day 25. The remaining animals survived to the scheduled sacrifice. Clinical Pathology Individual values for hematology, clinical chemistry, urinalysis, and hepatic palmitoyl-CoA oxidase are in Appendix 5. Mean values for each group and the results o f statistical comparisons are in Tables 9 through 11. 29 Covance 6329-224 3MT-6314.2 W eek 5. There were several statistically significant or otherwise notable differences for clinical pathology results between control and treated animals; only one o f the statistically significant differences affected animals fed less than 500 ppm. Differences considered to be effects o f the test material were lower red blood cell count, hemoglobin, and hematocrit; lower absolute eosinophil count; higher urea nitrogen; higher albumin and lower globulin; lower cholesterol; higher total bilirubin, aspartate aminotransferase, and alanine aminotransferase; and higher hepatic palmitoyl-CoA oxidase. With the exception o f lower globulin and higher aspartate aminotransferase for the females, these differences were statistically significant. O f uncertain relationship to administration o f N-MeFOSE were lower urine pH for males fed 500 ppm and small differences for animals fed 100 ppm including higher urea nitrogen, albumin, and alanine aminotransferase (males only) and lower cholesterol. O f the differences for animals fed 100 ppm, only the minor difference for alanine aminotransferase was statistically significant. At dose levels below 100 ppm, clinical pathology results were unaffected by treatment. The effects on the erythrocyte parameters (moderately decreased), eosinophil count (decreased), and globulin (mildly to moderately decreased) were consistent with animals in relatively poor health, failing to gain weight appropriately. Mildly higher urea nitrogen and moderately higher albumin were most consistent with mild dehydration and indicated the effects on other parameters (e.g., the erythrocyte parameters) might have been greater if the animals were normovolemic. The mild to moderate effects on alanine aminotransferase, aspartate aminotransferase, and total bilirubin were indicative o f the hepatocellular degeneration. The effect on cholesterol was marked, but the mechanism for change was not apparent. Moderately higher hepatic palmitoyl-CoA oxidase was indicative o f peroxisomal proliferation. Anatomical Pathology Individual anatomical pathology data are in Appendix 6. Individual absolute organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios are also in Appendix 6. M ean values for absolute and relative organ weights for each group are in Tables 12 through 14. Incidence summaries o f the macroscopic and microscopic observations are in Tables 15 and 16; the incidence o f severity o f selected microscopic observations is summarized in Table 17. 30 m Covance 6329-224 3M T-6314.2 Unscheduled Death. Animal No. C94523 given 500 ppm N-MeFOSE died on Day 25. Microscopically, this animal exhibited severe hepatocellular hypertrophy and moderately-severe liver necrosis. Terminal Sacrifice O rgan W eights. Mean absolute and relative (to brain and body) liver weights for all males and females given 100 and 500 ppm N-MeFOSE were significantly increased over control values, and these variations were regarded as treatment-related. All additional mean organ weights, which varied significantly from control values, were considered to be within the range or normal biologic variation, or were manifestations of slight weight loss associated with physiologic stress. M acroscopic Observations. Treatment-related, gross changes were restricted to the liver and stomach of males given 500 ppm N-MeFOSE. Animal Nos. C94521 and C94522 displayed enlarged livers, and in Animal No. C94522, hepatic enlargement was associated with discoloration (diffusely brown with light areas). Microscopically, liver changes were attributed to hepatocellular hypertrophy and necrosis. In addition to liver changes, dark or red mucosal areas were present in the glandular stomach o f Animal Nos. C94521 and C94526 given 500 ppm N-MeFOSE and in the glandular stomach of one control male (Animal No. C94493). Gastric areas were compatible with early "stress" erosions or ulcers. M icroscopic O bservations. Treatment-related microscopic changes were restricted to the liver o f both sexes and consisted o f hypertrophy (swelling) of liver cells in centrilobular regions o f the hepatic lobules. Occasionally, hypertrophic liver cells were associated with acute hepatic necrosis. Hepatocellular hypertrophy was not observed in controls or in animals given 1 or 10 ppm N-MeFOSE. At higher dose levels, hypertrophic changes were slightly more prevalent and severe in males, and at dose levels o f 30,100, and 500 ppm N-MeFOSE, all males displayed minimal to slight, moderate to moderately-severe, and moderately-severe to severe liver cell hypertrophy, respectively. Liver cell hypertrophy was not observed in females given 30 ppm N-MeFOSE; however, at dose levels o f 100 and 500 ppm N-MeFOSE, hepatocellular hypertrophy in females ranged from slight to moderate and from moderate to moderately-severe, respectively. Hepatocellular hypertrophy in both sexes was compatible with the proliferation of 31 Covance 6329-224 _____3M T-6314.2 cytoplasmic smooth endoplasmic reticulum. Although at lower doses hypertrophy was restricted to centrilobular regions, at the high-dose level, hypertrophic hepatocytes often extended into panlobular regions. In addition to hypertrophic changes, moderate liver cell necrosis was observed in two males given 500 ppm. Necrosis was attributed to local ischemia associated with liver cell swelling and occlusion o f regional blood supplies. Minimal hepatic necrosis in one o f six males given 10 o r 100 ppm and in one o f six females given 30 ppm Was consistent with common hepatic alterations in laboratory rats. All other microscopic findings were consistent with common spontaneous alterations in laboratory rats, including changes related to stress, nutritional status or tissue processing artifact. Diplomate, ACVP (Clinical Pathology) Diplomate, ACVP Pathology Associates International Covance 6329-224 3M T-6314.2 COMMENTS ON THE DATA Various models o f 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 o f the data was affected by these differences. The number o f animals listed in the heading o f the summary tables for clinical observations reflects the number o f animals assigned to each group at the start o f the study. The summary table for clinical observations indicate the number o f animals for which a condition was observed without regard to the specific nature, severity, reversibility, number o f incidences/animal, or the length o f time the condition persisted. Only observations other than normal are indicated on the summary clinical observations tables. Each animal with observations recorded as "Normal" throughout the study has the comment "Animal has no significant findings" indicated on the individual clinical observations tables. The specific details for comments in the individual clinical observations tables that are indicated with a "C" can be found at the end o f each group for each sex. The day o f initiation of treatment is "Day 1, W eek 1." Body weight data are entered at the start o f 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). Body weight change data are calculated from the first day o f the study week to the first day o f the following study week (e.g., Week 1 values are calculated from Day 1 through 7) and are indicated in the tables with the day being the first day o f the following week (e.g., Week 1 values are indicated as "Day 8"). Weekly food consumption and test material consumption are calculated from the first day o f the study week to the first day o f the following study week (e.g., Week 1 values are calculated from Day 1 through 7). The values for summary and individual test material consumption are reported with more significant figures than is appropriate for the data due to limitations o f the data collection and reporting software. 33 Covance 6329-224 3M T-6314.2 COM M ENTS ON THE DATA (Continued) Diet test material concentrations provided by the data collection system (PTS) are calculated to the nearest 0.1 ppm. These values are used for calculation o f test material consumption. For diet preparation purposes, the values are rounded to the appropriate accuracy for the balance used. Food consumption values are reported in whole numbers; however, PTS carries food consumption values to one place to the right o f the decimal for test material consumption calculations. The differences in values generated do not influence the interpretation o f the calculation. The comment "SPILLED" on individual food consumption data tables indicates that food consumption was not recorded due to spillage during the interval. The comment "NOT TAKEN" on individual food consumption data tables indicates the animal died before the end o f the food consumption interval. Differences in the population size (N) on the summary tables for clinical and anatomical pathology are explained on the individual data tables or the codes sheets. The calculation for individual test material consumption is: Test material consumption = ___________________________Diet ConcentrationxFood Consumption Food Consumption Intervalx[First Body Weight of Interval+ (Daily Body Weight GainxDay Factor)] where: Daily Body Weight Gain = Last Body Weight o f Interval- First Body Weight o f Interval Day o f Last Body Weight o f Interval- Day of First Body Weight o f Interval and: Day Factor = (Food Consumption Start Day- Day o f First Body Weight " f H - H ) Food ConsumPtion Interval 2 and: Food Consumption Interval = Food Consumption End Day- Food Consumption Start Day On pages 4 and 7 o f the protocol, the test material is indicated as MeFOS, T-6314 instead ofMeFOSE, T-6314. 34 CODES, ABBREVIATIONS, AND UNITS Covance 6329-224 3M T-6314.2 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 Anatomical Pathology Note: The following lists o f codes, abbreviations, and units are used by Covance. Some, but not necessarily all, o f this information may be needed for this report. 35 Covance 6329-224 3M T-6314.2 General Codes and Abbreviations WK N Mean; MEAN SD; S.D.; STAND DEV; STANDARD DEV; sd -;NA P C UNSCHED DISPATCH TBW # CO Week. Number o f measurements in a group. Arithmetic mean. Standard deviation. Group mean is significantly different from the mean of the control group (Group 1) at p s 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. Clinical observatioa 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 NOAGG FR UTD NO COAG Covance 6329-224 3M T-6314.2 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 o f 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 37 Covance 6329-224 3M T-6314.2 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 (BLETEME) 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), or basophilic stippling (BASTEP) or the presence of Howell-Jolly bodies (HJBODY), toxic neutrophils (TOXNEUT), or atypical lymphocytes (ATYPLYM): Scale 1 2 3 4 Degree Normal for the species Slight Moderate Marked N ot 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 0 Feces 38 Covance 6329-224 3M T-6314.2 Codes for Clinical Pathology (Continued) URINE CHEMISTRY MULTISTEX 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, a n d 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 39 Covance 6329-224 3M T-6314.2 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 Abbreviation (Units) RBC (E6/UL or XIOfytL) HGB (G/DL) HCT (%) M C V (FL) MCH (PG) MCHC (%) PLT (E3/UL or XIOV^L) MPV (FL) RETIC (%) RETIC (E3/UL or X103/aL) HEINZ (%) ESR (MM/HR) PT (SEC) PTT (SEC) TT (SEC) ACT (SEC) FBR (MG/DL) FDP (UG/ML) PAGG/COL (%) PAGG/ADP (%) ANTTPLAS (%) BLE TIME (SEC) METHGB (%) PLA HGB (MG/DL) M/E RATIO EST M/E RATIO WBC (E3/UL or X103///L) NRBC (/100 WBC) COR WBC (E3/UL or X103/L) N-SEG (E3/UL or X103///L) and % N-BAND (E3/UL or X103W and % LYMPH (E3/UL or X103//L) and % MONO (E3/UL or XIOV//L) and % EOSIN (E3/UL or X103/L) and % BASO (E3/UL or X103//L) and % ANISO (-,1,2,3) POLY (-,1,2,3) 40 Covance 6329-224 3M T-6314.2 Abbreviations and Units for Clinical Hematology (Continued) Test Pofldlocytosis 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) POIK (-,1,2,3) 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) 41 Covance 6329-224 3M T-6314.2 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) 42 Covance 6329-224 3M T-6314.2 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 A lp h a -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 -l (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) 43 Covance 6329-224 3M T-6314.2 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) SPGR U OSMO (MOSM/KG) QUAN PRO (MG/DL) PRO EXC (MG) UPH U PRO (MG/DL) UGLU UKET U BILI U BLOOD UROBELI 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 Fecal parasite detection Hemolytic potential Osmolality Not applicable N ot applicable Not applicable OSMO (MOSM/KG) 44 >i Code T D Codes for Anatomical Pathology Definition ANIMAL DEATH CODES Terminal sacrifice Found dead Covance 6329-224 _____3M T-6314.2 EX NOT TAKEN M ISSIN G UNSUITABLE AUTOLYTIC EXCLUDE M ACROSCOPIC 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 M ICROSCOPIC CODES 1X T* 21 f2x Codes Prefacing Neoplastic Findings B- Primary, benign neoplasm Primary, malignant neoplasm Metastatic neoplasm Locally invasive neoplasm Other neoplasm Code Definition D istribution of Findings Focal Diffuse Multifocal 45 Covance 6329-224 3MT-6314.2 Codes for Anatomical Pathology (Continued) 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 o f change, but readily discernible as abnormal 3 Moderate - the average amount o f change that is expected for a lesion 4 Moderately severe (marked) - a marked amount of change with possible loss of function o f 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 o f the organ Other Microscopic Codes TL Total P Finding present - funding not present MN Mean TISSUE ABBREVIATIONS Abbreviation LN GL STOMACH, GL STOMACH, NONGL SALIV GL, MAND IB LN, ANT MES/PANC AUDITORY SEB GL LACRIMAL GLAND, EX HEMATO NEOPLASIA LACRIMAL GL, [NT CAVITY, ABDOM SA U V GL,PAROTID LN, TRACHEOBRON CATHETER EXIT CATHETER ENTRANC CATHETER EXIT Definition 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 Catheterization site: exit site from the body Catheterization site: entrance site into the vessel Catheterization site: tissues (vascular or extravascular) associated with the catheter near its tip 46 Table 1 Covance 6329-224 3M T-6314.2 Results o f Homogeneity Analyses (ppm) Mixed 5/19/98 4-Week Range-Finding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Sample Location Replicate ___________ T-6314 (ppm)_________________ 10__________ 30__________ 100 500 Top 1 1.17 10.3 2 1.07 9.27 Middle 3 Mean 1 1.12 1.12 (112)a 1.36 9.20 9.59 (95.9) 9.48 2 1.35 3 1.25 10.4 9.71 Bottom Mean 1 2 1.32(132) 1.89 1.21 9.86 (98.6) 10.6 10.9 3 1.19 9.13 Mean 1.43 (143) 10.2 (102) a Each value in parenthesis is the percent of theoretical. 26.7 27.7 29.9 28.1 (93.7) 30.6 27.5 29.3 29.1 (97.0) 26.7 28.7 30.0 28.5 (95.0) 92.6 93.6 97.0 94.4 (94.4) 95.4 96.2 95.9 95.8 (95.8) 93.3 92.2 97.8 94.4 (94,4) 481 481 481 481 (96.2) 511 482 522 505 (101) 477 468 466 470 (94.0) 47 Table 1 (Continued) Covance 6329-224 3M T-6314.2 Results o f Homogeneity Analyses (ppm) Mixed 6/11/98 4-W eek Range-Fmding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats T-6314 (ppm) Sample Location Replicate___________ 1 T op 1 1.10 2 1.22 3 1.23 Topb Mean 1 1.18 (118) 1.23 2 1.15 3 1.10 Middle Mean 1 1.16(116) 2.91 2 1.40 3 3.73 Middleb Mean 1 2.68 (268) 1.15 2 1.11 3 1.16 Bottom Mean 1 1.14(114) 1.20 2 1.45 3 1.21 Bottomb Mean 1 1.29 (129) 1.01 2 0.986 3 1.06 Mean 1.02 (102) Each value in parenthesis is the percent o f theoretical. Reassay. 48 Covance 6329-224 3M T-6314.2 Table 2 Results of Stability Analyses (ppm) Mixed 5/19/98 4-Week Range-Ending Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Storage Conditions Replicate T-6314 (ppm) 1 500 Initial 1 2 3 Mean 1.36 1.35 1.25 1.32 (132)a 511 482 522 505 (101) At least 19 days, room temperature, 1 2 Mean - 457 444 451 (90.2) At least 32 days, room temperature 1 2 Mean - 420 414 417 (83.4) 8 weeks, frozen 1 2 Mean - 494 477 486 (97.2) 62 days, room temperature 1 2 Mean - 304 402 353 (70.6) a Each value in parentheses is the percent o f theoretical. 49 Covance 6329-224 3M T-6314.2 Table 2 (Continued) Results of Stability Analyses (ppm) Mixed 6/30/98 4-Week Range-Finding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats T-6314 (ppm) Storage Conditions Replicate 1 Initial 1 2 Mean 0.777 0.674 0.726 (72.6)a a Each value in parenthesis is the percent o f theoretical 50 m Covance 6329-224 3M T-6314.2 Table 3 Results o f Dose Preparation Analyses (ppm) 4-Week Range-Finding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Week Replicate 0 1 T-6314 (ppm) 10 30 100 500 l-4 a 1 b 2.91 10.0 25.6 90.1 485 2 b 1.40 8.42 25.7 93.3 487 3 - 3.73 - - - - Mean - 2.68 (268)c 9.21 (92.1) 25.7 (85.7) 91.7 (91.7) 486 (97.2) 1-4M 1 - 1.15 - - - - 2 - 1.11 - - - - 3 - 1.16 - - - - Mean - 1.14(114) - - - - 4 1 b 0.777 10.0 29.3 91.1 488 2 b 0.674 9.27 25.3 89.9 482 Mean - 0.726 (72.6) 9.64 (96.4) 27.3 (91.0) 90.5 (90.5) 485 (97.0) a Results for the 1 ppm levels were derived from the sample collected from the middle o f the dose preparations for homogeneity analysis, b Below the limit o f quantitation (<0.5 ppm), c Each value in parenthesis is the percent o f theoretical, d reassay. 51 *r Covance 6329-224 3MT-6314.2 B Table 3 (Continued) Results o f Dose Preparation Analyses (ppm) 4-Week Range-Finding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Week Replicate 0 T-6314 (ppm) 1 10 30 100 500 4d 1 0.615 2 - 0.651 Mean - 0.633 (63.3)c 23.2 23.9 23.6 (78.7) - c Each value in parenthesis is the percent o f theoretical d reassay. 52 DAYS 1-32 CATEGORY KEYWORD QUALIFIER *** TOP OF LIST *** SKIN & PELAGE SORE/SCAB DORSAL-THORACIC-LEFT DORSAL-THORACIC-RIGHT * * * END OF L I S T * * * Table 4 Summary of Clinical Observations 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- MiILE-- 1234 56 0 1 10 30 100 500 666666 001000 001000 Covance 6329-224 3M T-6314.2 PAGE: 1 53 SEX: - GROUP: 1 DOSE: 0 DAY UNITS: PPM iN 6 MEAN 169 S.D. 11.2 4N 6 MEAN 193 S.D. 11.4 8N 6 MEAN 228 S.D. 13.3 11 N 6 MEAN 251 S.D. 14.8 15 N 6 MEAN 281 S.D. 15.7 18 N 6' MEAN 300 S.D. 18.2 22 N 6 MEAN 329 S.D. 20.8 Table 5 Summary of Body Weight Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------- MALE- 234 1 10 30 PPM PPM PPM 6 167 13.1 6 192 14.1 6 225 15.8 6 248 17.0 6 279 17.6 6 297 18.1 6 324 22.3 6 170 13.4 6 192 14.5 6 227 17.5 6 252 18.1 6 280 19.6 6 299 21.0 6 327 23.9 6 166 14.7 6 188 15.5 6 221 20.7 6 245 19.5 6 271 21.4 6 286 24.3 6 313 28.3 5 100 PPM 6 168 14.6 6 189 15.5 6 221 16.3 6 242 14.4 6 271 14.7 6 286 16/5 6 312 14.5 6 500 PPM 6 164 11.4 6 177 10.5 6 195* 8.3 6 211* 9.9 6 224* 6.8 6 236* 10.7 6 243* 16.0 Covance 6329-224 3M T-6314.2 PAGE: 1 54 SEX: - GROUP: 1 DOSE: 0 DAY UNITS: PPM 25 N 6 MEAN 347 S.D. 24.4 29 N 6 MEAN 367 S.D. 29.3 32 N 6 MEAN 352 S.D. 29.0 Table 5 Summary of Body Weight Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 2 1 PPM 6 342 23.4 6 359 24.6 6 347 24.9 -------- MALE3 10 PPM 4 30 PPM 6 343 23.1 6 362 25.9 6 348 26.4 6 328 30.5 6 350 32.8 6 334 32.0 5 100 PPM 6 327 13.8 6 344 15.7 6 329 14.6 6 500 PPM 5 251* 17.8 5 258* 15.7 5 238* 12.8 Covance 6329-224 3M T-6314.2 PAGE: 2 55 I SEX: - GROUP : 1 DOSE: 0 DAY UNITS: PPM 1N 6 MEAN 137 S.D. 11.7 4N 6 MEAN 152 S.D. 12.5 8N 6 MEAN 172 S.D. 12.4 11 N 6 MEAN 183 S.D. 11.9 15 N 6 MEAN 196 S.D. 13.6 18 N 6 MEAN 201 S.D. 14.8 22 N 6 MEAN 216 S.D. 15.7 Table 5 Summary of Body Weight Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------- FEMALE234 1 10 30 PPM PPM PPM 6 132 7.5 6 150 8.9 6 167 8.6 6 175 6.7 6 187 9.1 6 197 9.1 6 210 10.4 6 135 16.0 6 151 20.5 6 168 19.5 6 178 22.3 6 193 27.1 6 199 26.1 6 209 28.8 6 135 11.2 6 147 13.3 6 166 13.5 6 177 14.3 6 190 16.2 6 195 16.8 6 208 20.3 5 100 PPM 6 132 12.0 6 147 13.7 6 162 15.1 6 173 15.7 6 183 16.7 6 189 16.8 6 201 15.6 6 500 PPM 6 135 12.4 6 138 8.7 6 148 8.7 6 155* 9.7 6 162* 12.0 6 164* 12.8 6 171* 13.3 Covance 6329-224 3M T-6314.2 PAGE: 3 56 SEX: GROUP: DOSE: DAY UNITS: 25 N MEAN S.D. 29 N MEAN S.D. 32 N MEAN S.D. 1 0 PPM 6 225 17.9 6 237 18.5 6 223 18.7 Table 5 Summary of Body Weight Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-63X4) IN RATS ------- FEMALE- 234 1 10 30 PPM PPM PPM 6 218 11.2 6 230 12.7 6 215 11.3 6 218 32.3 6 226 34.4 6 214 31.7 6 217 20.8 6 227 22.2 6 213 20.8 5 100 PPM 6 206 16.7 6 215 16.1 6 202 13.7 6 500 PPM 6 174* 14.3 6 178* 16.0 6 164* 13.8 Covance 6329-224 3M T-6314.2 PAGE: 4 57 HEX. i - GROUP i 1 DOSE: 0 DAY UNITS: PPM 1-4 N MEAN S.D. 4-8 N MEAN S.D. 8-11 N MEAN S.D. 11-15 N MEAN S.D. 15-18 N MEAN S.D. 18-22 N MEAN S.D. 22-25 N MEAN S.D. 6 24 1.9 6 34 3.5 6 23 4.1 6 31 5.4 6 19 3.8 6 29 4.8 6 18 4.3 Table Summary of Body Weight Change Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 2 1 PPM 6 24 1.6 6 33 3.2 6 24 2.3 6 30 4.0 6 19 2.1 6 26 5.9 6 18 3.3 -------- MALE-- 34 10 30 PPM PPM 6 22 1.7 6 35 4.5 6 25 2.1 6 28 5.1 6 19 2.1 6 29 3.7 6 16 2.9 6 22 2.2 6 33 5.9 6 24 2.0 6 26 3.0 6 15 3.7 6 27 4.9 6 15 4.0 5 100 PPM 6 21 2.1 6 32 2.5 6 22 3.3 6 29 2.4 6 15 2.7 6 26 3.0 6 15 1.4 6 500 PPM 6 13* 5.0 6 19* 5.1 6 16* 3.1 6 13* 3.8 6 12* 5.5 6 8* 8.5 5 7* 1.9 Covance 6329-224 3M T-6314.2 PAGE: 1 58 GROUP : DOSE: DAY UNITS: 1 0 PPM 25-29 N MEAN S.D. 29-32 N MEAN S.D. 1-32 N MEAN S.D. 6 20 5.5 6 -15 2.2 6 183 26.2 Table 6 Summary of Body Weight Change Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 2 1 PPM 6 18 4.5 6 -13 3.1 6 179 18.9 3 10 PPM 6 19 4.5 6 -14 2.5 6 178 18.0 4 30 PPM 6 22 3.0 6 -15 2.7 6 168 21.5 5 100 PPM 6 16 2.6 6 -15 3.1 6 161 8.8 6 500 PPM 5 7* 4.1 5 -21* 3.8 5 75* 4.8 Covance 6329-224 3M T-6314.2 PAGE: 2 59 Table 6 Summary of Body Weight Change Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS GROUP: DOSE; DAY UNITS: 1-4 N MEAN S.D. 4-8 N MEAN S.D. 8-11 N MEAN S.D. 11-15 N MEAN S.D. 15-18 N MEAN S.D. 18-22 N MEAN S.D. 22-25 N MEAN S.D. 1 0 PPM 6 15 1.8 6 20 1.4 6 11 2.7 6 13 3.5 6 5 2.7 6 15 ' 4.7 6 10 5.2 2 1 PPM 6 18 4.4 6 17 1.6 6 8 3.7 6 12 3.2 6 10 1.3 6 14 2.7 6 8 3.1 3 10 PPM 6 16 5.6 6 17 2.4 6 10 7.7 6 15 8.8 6 6 7.3 6 10 3.7 6 10 4.3 4 30 PPM 6 13 5.4 6 19 1.0 6 11 2.8 6 13 2.4 6 6 1.4 6 13 4.0 6 9 3.2 5 100 PPM 6 15 4.7 6 15* 2.2 6 10 2.3 6 10 1.5 6 6 2.1 6 12 2.8 6 6 2.2 6 500 PPM 6 3* 5.6 6 10* 3.1 6 7 3.5 6 7* 3.5 6 2 4.5 6 7* 3.1 6 4 4.2 Covance 6329-224 3M T-6314.2 PAGE: 3 60 Table 6 Summary of Body Weight Change Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYIi PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS SEX: ----------------------------- FEMALE GROUP : 1 2 3 4 DOSE: 0 1 10 30 DAY UNITS: PPM PPM PPM PPM 25-29 N MEAN S.D. 29-32 N MEAN S.D. 1-32 N MEAN S.D. 6 12 3.3 6 -14 3.7 6 86 10.4 6 12 4.1 6 -15 2.0 6 83 6.9 6 8 3.0 6 -12 6.8 6 79 19.5 6 10 2.0 6 -15 2.2 6 78 14.3 5 100 PPM 6 9 3.3 6 -13 2.9 6 70 5.8 6 500 PPM 6 4* 3.2 6 -14 3.1 6 29* 12.7 Covance 6329-224 3M T-6314.2 PAGE: 4 61 SEX: - GROUP : 1 DOSE: 0 DAY UNITS: PPM 1N 6 MEAN 76 S.D. 5.5 4N 6 MEAN 102 S.D. 6.3 8N 6 MEAN 80 S.D. 7.1 11 N 6 MEAN 108 S.D. 9.3 15 N MEAN S.D. 6 81 7.7 18 N 6 MEAN 108 S.D. 8.9 22 N MEAN S.D. 6 88 8.5 Table 7 Summary of Food Consumption Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------MALE-- 234 1 10 30 PPM PPM PPM 6 76 7.3 6 102 8.4 6 80 7.2 6 109 9.0 6 82 7.1 6 108 10.9 6 89 7.0 6 72 4.3 6 100 6.5 6 80 4.4 6 105 8.0 6 80 5.2 6 105 6.7 6 87 6.3 6 71 4.2 6 96 7.9 6 77 4.2 6 101 6.8 6 73 6.5 6 100 8.4 6 80 5.0 5 100 PPM 6 71 5.8 6 94 7.6 6 73 4.7 6 100 7.7 6 74 5.6 6 98 6.1 6 78 4.4 6 500 PPM 6 64* 3.8 6 74* 6.9 6 60* 5.1 6 75* 4.9 6 59* 3.8 6 68* 7.1 5 54* 8.7 Covance 6329-224 3M T-6314.2 PAGE: 1 62 SEX: GROUP: DOSE: DAY UNITS: 25 1-25 N MEAN S.D. N MEAN S.D. 1 0 PPM 5 122 9.6 5 777 46.2 Table 7 Summary of Food Consumption Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 2 1 PPM 6 132 28.6 6 777 59.5 -MALE- 3 10 PPM 4 30 PPM 6 115 9.5 6 742 47.5 6 110 10.6 6 707 50.6 5 100 PPM 6 104 8.8 6 692* 47.9 6 500 PPM 5 72* 4.2 5 525* 23.0 Covance 6329-224 3M T-6314.2 PAGE: 2 63 Table 7 Summary of Food Consumption Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS GROUP: DOSE: DAY UNITS: iN MEAN S.D. 4N MEAN S.D. 8N MEAN S.D. 11 N MEAN S.D. 15 N MEAN S.D. 18 N MEAN S.D. 22 N MEAN S.D. 1 0 PPM 6 61 7.1 6 77 8.4 6 58 5.2 6 80 4.7 6 58 3.1 6 77 ' 6.4 6 62 7.5 2 1 PPM 6 62 5.2 6 78 2.8 6 58 2.8 6 79 5.9 6 60 4.4 6 79 5.9 6 63 5.1 3 10 PPM 6 60 10.2 6 74 10.9 6 56 10.4 6 77 15.8 6 55 9.6 6 69 12.0 6 58 9.0 4 30 PPM 6 58 6.9 6 76 6.9 6 58 5.5 6 76 7.6 6 55 5.6 6 75 10.7 6 60 9.5 5 100 PPM 6 58 3.8 6 72 3.4 6 56 2.7 6 72 4.0 6 53 3.1 6 73 6.5 6 55 3.3 6 500 PPM 6 51 6.2 6 53* 5.8 6 45* 2.9 5 55* 7.3 6 41* 8.1 6 52* 5.0 6 42* 5.2 Covance 6329-224 3M T-6314.2 PAGE: 3 64 GROUP : DOSE: DAY UNITS: 25 1-25 N MEAN S.D. N MEAN S.D. 1 0 PPM 5 82 9.4 5 551 44.0 Table 7 Summary of Food Consumption Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 2 1 PPM 6 86 8.3 6 565 34.0 3 10 PPM 6 80 13.0 6 529 82.4 4 30 PPM 5 75 7.0 5 517 45.0 5 100 PPM 5 73 5.8 , 5 513 20.8 6 500 PPM 6 54* 7.6 5 388* 39.7 Covance 6329-224 3M T-6314.2 PAGE: 4 65 Table 8 Summary of Test Material Consumption Data (mg/kg/day) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 1 SEX: -------------------------MALE------------------------- ----- GROUP: 2 3 4 5 6 2 DOSE: 1 10 30 100 500 1 DAY UNITS: PPM PPM PPM PPM PPM PPM -----------FEMALE--------------------- 34 56 10 30 100 500 PPM PPM PPM PPM 1N MEAN S.D. 4N MEAN S.D. 8N MEAN S.D. 11 N MEAN S.D. 15 N MEAN S.D. 18 N MEAN S.D. 22 N MEAN S.D. 6 0.140 0.005 6 0.123 0.006 6 0.113 0.005 6 0.103 0.005 6 0.095 0.005 6 0.087 0.007 6 0.089 0.004 6 1.325 0.044 6 1.191 0.048 6 1.117 0.047 6 0.984 0.054 6 0.921 0.030 6 0.837 0.027 6 0.863 0.041 6 4.030 0.210 6 3.524 0.132 6 3.311 0.258 6 2.951 0.137 6 2.617 0.094 6 2.500 0.067 6 2.501 0.118 6 13.192 0.692 6 11.506 0.605 6 10.505 0.601 6 9.711 0.538 6 8.797 0.412 6 8.227 0.423 6 8.150 0.234 6 62.612 4.144 6 49.583 5.932 6 49.261 4.268 6 43.192 3.772 6 42.446 2.463 6 35.210 2.563 5 36.296 3.715 6 0.147 0.008 6 0.123 0.004 6 0.113 0.003 6 0 .1 10 0.005 6 0.104 0.004 6 0.097 0.006 6 0.098 0.005 6 1.399 0.098 6 1.164 0.093 6 1.074 0.128 6 1.027 0.116 6 0.928 0.072 6 0.848 0.078 6 0.910 0.061 6 4.124 0.320 6 3.625 0.145 6 3.393 0.198 6 3.105 0.143 6 2.872 0.128 6 2.764 0.208 6 2.790 0 .2 2 1 6 13.802 0.732 6 11.716 0.618 6 11.133 0.662 6 10.115 0.449 6 9.609 0.678 6 9.517 1.572 6 9.089 0.957 6 62.217 8.174 6 46.216 6.426 6 49.206 1.743 5 43.613 3.405 6 41.810 6.302 6 38.527 2.059 6 40.035 2.173 Table 8 Summary of Test Material Consumption Data (mg/kg/day) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 2 SEX: ------------------------- MALE----------- GROUP: 2 3 4 5 DOSE: 1 10 30 100 DAY UNITS: PPM PPM PPM PPM 25 1-25 N MEAN S.D. MEAN 6 0.094 0.022 0.105 6 0.816 0.020 1.007 6 2.432 0.146 2.983 6 7.768 0.406 9.732 ------- 6 500 PPM ------------------------ FEMALE--------------------- 2 34 56 1 10 30 100 500 PPM PPM PPM PPM PPM 5 35.168 1.938 44.590 6 0.096 0.005 0 .1 11 6 0.905 0.044 1.032 5 2.612 0.138 3.172 5 8.485 0.647 10.475 6 38.539 3.754 45.050 67 Table 9 Summary of Clinical Hematology Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT 2FOS X106/^L G/DL % FL PG % X103/m L MEAN S.D. N MEAN S.D. N 10 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 500 MEAN S.D. N 7.29 15.0 .448 .58 66 44.6 1.89 6 61.2 1.82 6 7.34 .253 6 14.6 .58 6 44.1 2.12 6 60.0 2.26 6 7.27 .209 6 14.9 .43 6 44.0 1.27 6 60.6 1.76 6 7.40 .156 6 15.0 .44 6 44.5 1.07 6 60.2 1.16 6 7.00 .719 6 14.6 1.12 6 43.1 3.46 6 61.6 1.73 6 5.90 * .623 5 12.3 * 1.00 5 36.0 * 3.11 5 61.1 2.07 5 20.6 .72 6 20.0 .84 6 20.5 .70 6 20.2 .43 6 20.8 .75 6 20.9 1.10 5 33.6 .29 6 33.4 .68 6 33.8 .20 6 33.7 .47 6 33.8 .39 6 34.1 .67 5 988 133 6 1058 157 6 1044 110 6 1057 177 6 1114 148 6 967 183 5 Covance 6329-224 3M T-6314.2 68 DOSE WBC iFOS X103/m L Table 9 Summary of Clinical Hematology Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH X103/^L X103/m L MONO EOS IN BASO N-SEG% XloV^iL X103/m L X103/^L LYMPH% MONO% EOSIN% Covance 6329-224 3M T-6314.2 BASO% MEAN 11.6 1.0 9.4 .9 . 2 .0 S.D. 3.14 .43 2.46 .44 .17 .04 N 66 6666 9 82 8 1 2.5 4.6 3.6 1 . 0 6666 0 .4 6 MEAN S.D. N 11.7 3.43 6 1.4 .74 6 9.5 2.59 6 . 8 . 1 . 0 1 2 81 6 .40 .04 .04 3.6 4.4 1 . 6 666 6 6 6 1 .4 6 0 .0 6 10 MEAN 13.6 1.4 1 1 . 2 .8 . 2 . 0 1 2 80 7 1 0 S.D. 4.76 .57 4.57 .22 .10 .04 5.1 9.9 4.5 .4 .4 N 66 6666 6 6 66 6 30 MEAN S.D. N 12.3 1.13 6 .8 .15 6 10.6 1 .2 1 6 .8 .33 6 .1 .05 6 .0 .00 6 6 86 1 . 2 3.5 66 6 2.9 6 1 .0 6 0 .0 6 100 MEAN S.D. N 13.0 3.24 6 1.1 .27 6 1 1 .1 2.72 6 .6 .48 6 .1 .00 6 .0 .04 6 9 86 2 . 2 3.4 66 4 2.3 6 1 .0 6 0 .0 6 500 MEAN S.D. N 10.4 1.72 5 1.3 .82 5 8.4 1.40 5 .6 .0 * .0 12 82 5 .27 .04 .04 7.2 8.9 2 . 1 555 5 5 5 00 .4 .4 55 69 Table 9 Summary of Clinical Hematology Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT aFOS x i o 6/ml G/DL % FL PG % X103/*<L MEAN S.D. N MEAN S.D. N 10 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 500 MEAN S.D. N 7.12 .613 6 14.8 .65 6 43.5 2.12 6 61.2 2.78 6 20.8 1.05 6 7.41 .316 6 15.3 .51 6 45.0 1.34 6 60.8 1.29 6 20.7 .35 6 7.62 .466 6 15.6 .95 6 46.4 2.34 6 61.0 1.87 6 20.5 .46 6 7.19 .272 6 14.8 .50 6 43.4 1.82 6 60.4 ' .67 6 20.6 .20 6 7.40 .386 6 15.0 .58 6 44.1 1.61 6 59.6 1.46 6 20.2 .45 6 6.34 * .381 6 12.6 * 1.08 6 36.8 * 3.47 6 58.1 3.37 6 20.0 1.00 6 34.0 .34 6 34.0 .35 6 33.6 .44 6 34.2 .43 6 33.9 .34 6 34.4 .58 6 1012 90 6 1005 133 6 976 131 6 1027 72 6 1069 123 6 1042 160 6 Covance 6329-224 3M T-6314.2 70 DOSE WBC 2FOS X103/^L Table 9 Summary of Clinical Hematology Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH X1 0 3/m L XIOV^L MONO EOSIN BASO N-SEG% X103/^L X103///L X103/m L LYMPH% MONO% EOSIN% Covance 6329-224 3M T-6314.2 BASO% MEAN 7.1 . 6 5.8 .7 .1 .0 1 0 82 8 1 0 S.D. 3.40 .33 2.77 .72 .04 .04 6 . 1 5.7 5.8 .0 N 6 66 666 666 66 MEAN 8.0 . 6 7.0 .4 . 1 .0 S.D. 3.87 .32 3.68 .13 .08 .00 N 666 666 10 MEAN 8.0 .5 6 . 8 .6 .1 .0 S.D. 2.94 .33 2.34 .38 .04 .00 N 666666 30 MEAN S.D. N 11.3 3.55 6 .9 9.8 .50 3.18 66 .5 . 1 .25 . 0 0 66 .0 .00 6 100 MEAN 11.6 . 6 10.4 .5 . 1 .0 S.D. 2.96 .08 2.99 .34 .05 .00 N 6 66 66 6 500 MEAN 11.4 . 6 10.5 .4 .0 * .0 S.D. 3.95 .28 3.85 .16 .00 .04 N 666666 8 86 4.6 5.6 66 7 85 2 . 2 3.4 66 8 87 4.1 5.2 66 5 89 * 1 . 0 4.1 66 5 91 * 2.9 3.3 66 5 2.0 6 7 3.0 6 4 1.5 6 5 3.4 6 3 1.3 6 1 .8 6 1 .0 6 1 .0 6 1 .4 6 0 .0 6 0 .0 6 0 .0 6 0 .0 6 0 .0 6 0 .0 6 71 DOSE ppm MeFOS Table 10 Summary of Clinical Chemistry Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL 0 MEAN 155 14 . 6 6 . 1 4.5 1 . 6 . 2 47 S.D. 39.1 1.5 .15 .29 .26 . 1 0 .10 9.7 N 6 66 66 6 66 1 MEAN S.D. N 135 16.2 6 13 2.5 6 .6 .21 6 6.3 .35 6 4.6 .26 6 1.7 .12 6 . 1 55 . 1 0 13.2 66 10 MEAN 138 12 . 6 6 . 1 4.5 1 . 6 . 2 44 S.D. 32.5 1.8 .20 .18 . 1 0 .18 .16 1 2 . 6 N 666 66 666 30 MEAN 141 12 . 6 6 . 2 4.5 1 . 6 S.D. 39.7 1.4 .14 .42 . 2 2 .23 N 666 66 6 . 2 40 .16 1 1 . 0 66 100 MEAN 116 16 . 6 6 . 2 4.8 1.5 S.D. 39.8 1.6 .10 .48 .29 . 2 2 N 666 66 6 . 1 35 .08 18.7 66 500 MEAN 107 22 * .6 6.0 5.1 * .9 * .7 * S.D. 17.1 2.7 .26 .34 .36 .17 .28 N 5555555 1* 1.6 5 Covance 6329-224 3M T-6314.2 72 Table 10 Summary of Clinical Chemistry Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE AST/SGOT ALT/SGPT 5FOS IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L PCOAO IU/G Covance 6329-224 3M T-6314.2 MEAN S.D. N MEAN S.D. N 10 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 500 MEAN S.D. N 96 5.0 6 117 26.6 6 109 24.7 6 93 10.4 6 122 20.3 6 165 * 87.3 5 34 3.0 6 32 10.3 6 35 5.2 6 36 6.4 6 48 * 11.7 6 222 * 204.3 5 0 10.9 . 0 .23 66 0 .5 6 11.2 .19 6 0 11.3 . 0 .44 66 0 .5 6 11.2 .44 6 0 10.8 . 0 .62 66 0 10.4 . 0 .46 55 1 2 .1 .84 6 1 2 .1 1.54 6 11.8 1.92 6 11.0 .85 6 11.3 .84 6 10.8 1.22 5 148 2.6 6 148 1.6 6 148 2.9 6 149 .8 6 148 1.0 6 145 2.2 5 7.1 1.29 6 7.5 1.75 6 7.5 1.93 6 6.6 .56 6 7.2 .88 6 8.2 .42 5 102 1.2 6 101 1.4 6 102 .8 6 102 1.9 6 101 2.3 6 101 1.7 5 9 1.8 6 9 2.5 6 8 1.9 6 8 2.4 6 6 .8 6 32 * 4.3 5 73 DOSE ppm MeFOS Table 10 Summary of Clinical Chemistry Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL 0 MEAN S.D. N 103 11.3 6 14 1.0 6 . 8 6.4 5.0 1.4 .23 .75 .56 .25 6 66 6 1 MEAN 112 15 . 6 6.5 5.1 1.4 S.D. 24.3 1.7 .23 .36 .26 .27 N 66 666 6 10 MEAN S.D. N 99 14 . 6 6.4 5.1 1.3 22.2 3.0 . 1 0 .37 .34 . 1 0 66 666 6 30 MEAN 131 15 .7 6.4 5.1 1.3 S.D. 28.4 3.8 .24 .79 .67 .13 N 66 6 66 6 100 MEAN 112 17 .7 6.7 5.5 1 . 2 S.D. 33.9 5.8 .15 .52 .34 . 2 1 N 66 6 66 6 500 MEAN S.D. N 100 20.6 6 26 * 3.9 6 .6 7.0 5.9 * 1 .1 .18 .48 .29 . 2 0 666 6 .1 .10 6 .2 .10 6 .2 .08 6 .1 .15 6 .2 .08 6 .5 * .28 6 45 11.5 6 55 1 1 .1 6 46 10.7 6 54 9.5 6 38 17.1 6 7* 5.9 6 Covance 6329-224 3M T-6314.2 74 Table 10 Summary of Clinical Chemistry Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE AST/SGOT ALT/SGPT ppm MeFOS IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L Covance 6329-224 3M T-6314.2 PCOAO IU/G 0 MEAN S.D. N 1 MEAN S.D. N 10 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 500 MEAN S.D. N 104 14.0 6 107 15.1 6 125 36.5 6 100 22.0 6 90 9.1 6 118 21.4 6 27 2.7 6 30 1.2 6 27 6.1 6 28 7.4 6 29 4.8 6 60 * 16.4 6 0 10.9 .8 .66 66 0 11.4 . 8 .47 66 0 11.1 . 0 .59 66 1 11.1 1.5 .61 66 0 11.4 . 0 .54 66 0 10.9 . 0 .50 66 11.6 .95 6 12.4 1.63 6 11.9 1.20 6 10.5 .84 6 11.5 .99 6 10.6 .65 6 147 ,9 6 147 2.5 6 146 1.4 6 146 2.7 6 147 1.3 6 148 1.8 6 7.9 1.34 6 8.2 1.76 6 8.9 .83 6 7.0 1.06 6 7.6 .49 6 6.8 .77 6 103 1. 6 104 1, 6 103 1 6 102 1 6 103 1 6 102 3 6 00 m VO VO CN VO tH V0 VO rH VO 5 1.6 6 30 * 12.0 6 75 Table 11 Summary of Clinical Urinalysis Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE bFOS U VOL ML SP GR U PH MEAN S.D. N MEAN S.D. N 10 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 500 MEAN S.D. N 18.5 9.86 6 27.7 22.39 6 28.4 13.81 6 26.0 14.80 6 15.9 17.26 6 20.4 15.52 5 1.017 .0096 6 1.015 .0112 6 1.0 10 .0027 6 1.013 .0069 6 1.023 .0107 6 1.019 .0126 5 7.4 .20 6 7.2 .27 6 7.2 .26 6 6.9 .20 6 6.9 .58 6 6.8 * .27 5 Covance 6329-224 3M T-6314.2 76 Table 11 Summary of Clinical Urinalysis Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE U VOL iFOS ML SP GR U PH MEAN S.D. N MEAN S.D. N 10 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 500 MEAN S.D. N 30.6 20.36 6 1.0 10 .0077 6 25.7 17.62 6 1.008 .0044 6 27.1 16.49 6 1.008 .0064 6 15.0 9.40 6 1.015 .0097 6 29.0 17.62 6 1.008 .0056 6 14.8 12.98 6 1.0 11 .0046 6 7.1 .38 6 7.0 .32 6 6.9 .20 6 7.1 .38 6 7.0 .32 6 7.0 .32 6 Covance 6329-224 3M T-6314.2 77 TABLE 12 Summary of Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 1 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX: GROUP : NUMBER: 6 -- 2 -- 6 ------ HALE-------- -- 3-- -- 4-- - -- 5-- 666 -- 6 -- 5 ------FEM.ALE------- -- 2 -- -- 4-- -- 5-- -- 6 -- 66 666 6 TERMINAL BODY WEIGHT (g) # IN GRP : 6 M E A N : 341.8 STAND DEV: 29.6 6 337.9 24.7 6 337.2 25.3 6 323.1 31.3 6 320.7 15.0 5 227.8* 11.4 6 213.3 17.8 6 205.9 12.0 6 203.7 32.0 6 204.3 2 1 .1 6 193.6 13.9 6 156.6* 13.2 AD - ADRENAL # IN GRP : MEAN: STAND DEV: 6 0.0577 0.0106 6 0.0571 0.0063 6 0.0608 0.0088 6 0.0520 0.0086 6 0.0547 0.0094 5 0.0569 0.0112 6 0.0731 0.0148 6 0.0687 0.0071 6 0.0749 0.0229 6 0.0639 0.0087 6 0.0661 0.0068 6 0.0464* 0.0114 BR - BRAIN # IN GRP : MEAN: STAND DEV: 6 2.0588 0.1028 6 2.0352 0.0854 6 2.0175 0.1200 6 2.1275 0.1430 6 2.0927 0.0928 5 2.0009 0.1027 6 1.9550 0.0500 6 1.9833 0.1088 6 1.9873 0.0735 6 2.0235 0.1071 6 2.0041 0.0906 6 1.9920 0.1159 EP - EPIDIDYMIDES # IN GRP : 6 6 6 6 6 50 0 0 0 0 0 MEAN: 0.9214 0.8976 0.9760 0.8663 0.8447 0.7317 * STAND DEV: 0.0821 0.0555 0.0886 0.0785 0.1274 0.0679 78 TABLE 12 Summary of Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX GROUP NUMBER -- 2-- -------MALE -- 4-- -- 5-- -- 6-- 6 66 665 6 KD - KIDNEY # IN GRP MEAN STAND DEV 6 3.3984 0.3295 6 3.1034 0.3872 6 3.3466 0.2597 6 3.2329 0.3284 6 3.2922 0.2223 5 2.5925* 0.2256 6 2.0935 0.2961 LI - LIVER # IN GRP MEAN STAND DEV 6 12.9118 1.7284 6 12.4546 1.0193 6 12.7132 0.8627 6 12.3245 1.7057 65 16.7113* 19.6094* 1.7399 1.0341 6 7.7513 0.7450 OV - OVARY # IN GRP 0 0 0 0 0 0 6 MEAN 0.1272 STAND DEV 0.0243 SP - SPLEEN # IN GRP MEAN STAND DEV 6 0.8049 0.0654 6 0.7518 0.0904 6 0.7777 0.0914 6 0.7072 0.1085 6 0.6731 0.1114 5 0.5820* 0.0775 6 0.5080 0.1069 ------ FEMALE -- 3-- -4-- -- 5-- -- 6 -- 66 666 6 1.9685 0.1666 6 2.2523 0.3837 6 2.0578 0.1457 6 2.1936 0.2491 6 1.7253 0.1934 6 7.5539 0.6425 6 7.9991 1.2215 6 8.3214 1.2523 66 9.6111* 12.3797* 0.7628 1.7764 6 0.1311 0.0128 6 0.1376 0.0200 6 0.1185 0.0273 6 0.1163 0.0155 6 0.0763* 0.0181 6 0.5032 0.0719 6 0.4927 0.1181 6 0.4929 0.0710 6 0.4743 0.0810 6 0.4265 0.0686 79 TABLE 12 Summary of Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFQNAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 3 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T ;SUBSET=ALL SEX GROUP NUMBER -------MALE- -- 2-- -4-- -- 5-- -- 6 -- 66666 5 6 -- 2-- - 6 TE - TESTIS # IN GRP : MEAN: STAND DEV: 6 3.0558 0.2644 6 2.9480 0.1952 6 3.0071 0.2583 6 2.9256 0.2156 6 2.9717 0.1282 5 2.9968 0.2885 0 TH - THYMUS 0 # IN GRP MEAN STAND DEV 6 0.6039 0.1774 6 0.6833 0.1692 6 0.6890 0.1418 6 0.5854 0.0721 6 0.6600 0.1124 5 0.4490 0.1074 6 0.5455 0.0592 6 0.5229 0.1124 TT - THYROID/PARATHYR # IN GRP MEAN STAND DEV 6 0.0206 0.0049 6 0.0234 0.0050 6 0.0226 0.0033 6 0.0206 0.0068 6 0.0219 0.0039 5 0.0197 0.0061 6 0.0159 0.0019 6 0.0181 0.0032 6 0 6 0.5321 0.0918 5 0.0193 0.0043 -4-- -- 5-- -- 6 -- 6 66 0 00 6 0.5484 0.0854 6 0.5062 0.1873 6 0.4587 0.1086 6 0.0184 0.0063 6 0.0181 0.0049 6 0.0137 0.0031 80 TABLE 13 Summary of Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 1 TABLE INCLUDI2S: SEX=ALL;G110UP=ALL;WEEKS=ALL DEATH=T ;SIJBSET=ALL SEX: GROUP : NUMBER: 6 -- 2 -- 6 -- 3-- 6 -- 4-- 6 -- 5-- 6 -- 6-- 5 -- 1-- 6 AD - ADRENAL # IN GRP : MEAN: STAND DEV: 6 0.0171 0.0044 6 0.0170 0.0027 6 0.0181 0.0031 6 0.0162 0.0030 6 0.0170 0.0023 5 0.0249* 0.0042 6 0.0343 0.0063 BR - BRAIN # IN GRP : MEAN: STAND DEV: 6 0.6058 0.0562 6 0.6049 0.0496 6 0.6006 0.0511 6 0.6626 0.0650 6 0.6536 0.0404 5 0.8801* 0.0642 6 0.9213 0.0679 EP - EPIDIDYMIDES # IN GRP : MEAN: STAND DEV: 6 0.2708 0.0282 6 0.2672 0.0292 6 0.2901 0.0251 6 0.2688 0.0210 6 0.2629 0.0316 5 0.3208* 0.0193 0 KD - KIDNEY # IN GRP : MEAN: STAND DEV: 6 0.9957 0.0730 6 0.9210 0.1214 6 0.9927 0.0327 6 1.0030 0.0801 6 1.0264 0.0465 5 1.1372* 0.0646 6 0.9798 0.0858 l 1 1 CN VO 1 1l -- 3-- 1 6 1 1 _ 4 -- 6 -- 5-- 6 -- 6-- 6 6 0.0333 0.0030 6 0.0363 0.0075 6 0.0312 0.0022 6 0.0342 0.0032 6 0.0295 0.0062 6 0.9648 0.0592 6 0.9925 0.1298 6 0.9962 0.0758 6 1.0372* 0.0438 6 1.2757* 0.0644 0 00 00 6 0.9565 0.0640 6 1.1053* 0.0733 6 1.0105 0.0442 6 1.1315* 0.0744 6 1 .1 0 2 1 * 0.0843 81 TABLE 13 Summary of Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;S UBSET=ALL SEX: GROUP : NUMBER: 6 -- 2 -- 6 -- 3-- 6 -- 4-- 6 # IN GRP : MEAN: STAND DEV: 6 3.7673 0.2855 6 3.6892 0.2180 6 3.7731 0.1192 6 3.8050 0.2642 # IN GRP : 0 0 0 0 MEAN: STAND DEV: # IN GRP : MEAN: STAND DEV: 66 0.2374 0.2226 0.0317- - 0.0242 6 0.2311 0.0261 6 0.2193 0.0297 # IN GRP : MEAN: STAND DEV: 6 0.8974 0.0834 6 0.8749 0.0693 6 0.8978 0 .12 12 6 0.9084 0.0596 -- 6-- -- 1 -- -- 2 -- -- 3-- -- 4-- -- 5-- -- 6 -- 6 56 6 6 6 6 6 LI - LIVER 6 5.2193* 0.5890 5 8.6147* 0.4240 6 3.6336 0.1378 6 3.6701 0.2643 6 3.9342 0.2503 6 4.0598* 0.2523 6 4.9671* 0.2573 6 7.8932* 0.7492 OV - OVARY 00666 666 0.0595 0.0638 0.0681 0.0580 0.0603 0.0485 0.0086 0.0070 0.0093 0 . 0 1 2 2 0.0092 0.0097 SP - SPLEEN 6 0.2110 0.0412 5 0.2566 0.0414 6 0.2377 0.0411 6 0.2446 0.0344 6 0.2398 0.0285 6 0.2407 0.0167 6 0.2447 0.0353 6 0.2727 0.0400 TE - TESTIS 6 50 0 0 0 0 0 0.9280 1.3135* 0.0567 0.0803 82 TABLE 13 Summary of Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 3 TABLE INCIjUDES : SEX=ALI ;GROUP=ALL ;WEEKS=ALL DEATH=1 SUBSET=ALL SEX GROUP -- 2 -- -- 3-- ' ~ -- 4-- -- 5 -- -- 6 -- -- 2 -- NUMBER 6 6 6 6 6 56 6 TH - THYMUS # IN GRP MEAN STAND DEV 6 0.1768 0.0498 6 0.2015 0.0425 6 0.2027 0.0277 6 0.1820 0.0234 6 0.2068 0.0401 5 0.1970 0.0465 6 0.2566 0.0280 6 0.2553 0.0627 TT - THYROID/PARATHYR # IN GRP MEAN STAND DEV 6 0.0060 0.0011 6 0.0070 0.0016 6 0.0067 0.0009 6 0.0063 0.0017 6 0.0068 0.0011 5 0.0087 0.0027 6 0.0075 0.0013 6 0.0088 0.0015 6 6 0.2628 0.0391 5 0.0098 0.0024 -4-- 6 -- 5-- 6 -- 6-- 6 6 0.2695 0.0417 6 0.2598 0.0915 6 0.2915 0.0530 6 0.0090 0.0028 6 0.0093 0.0021 6 0.0088 0.0020 83 k TABLE 14 Summary of Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 1 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=T;SUBSET=ALL SEX GROUP NUMBER -------MALE ------ FEMALE------ -- 2 -- -- 4 -- -- 5-- -- 6-- -- 1 -- -- 2 -- -- 3-- -- 4-- -- 5-- -- 6 -- 6 6 6 6 6 56 6 6 6 6 6 AD - ADRENAL # IN GRP MEAN STAND DEV 6 0.0282 0.0056 6 0.0281 0.0035 6 0.0303 0.0052 6 0.0243 0.0028 6 0.0263 0.0055 5 0.0285 0.0060 6 0.0375 0.0081 6 0.0348 0.0049 6 0.0375 0.0109 6 0.0316 0.0037 6 0.0330 0.0029 6 0.0232* 0.0055 BR - BRAIN # IN GRP MEAN STAND DEV 6 1.0000 0.0000 6 1.0000 0.0000 6 1.0000 0.0000 6 1.0000 0.0000 6 1.0000 0.0000 5 1.0000 0.0000 6 1.0000 0.0000 6 1.0000 0.0000 6 1.0000 0.0000 6 1.0000 0.0000 6 1.0000 0.0000 6 1.0000 0.0000 EP - EPIDIDYMIDES # IN GRP : 6 6 6 6 6 50 0 0 0 0 0 MEAN: 0.4479 0.4419 0.4852 0.4082 0.4057 0.3658* STAND DEV: 0.0374 0.0357 0.0526 0.0411 0.0763 0.0305 KD - KIDNEY # IN GRP MEAN STAND DEV 6 1.6539 0.1800 6 1.5214 0.1402 6 1.6641 0.1680 6 1.5184 0.0923 6 1.5770 0.1476 5 1.2978* 0.1248 6 1.0710 0.1534 6 0.9951 0.0990 6 1.1299 0.1651 6 1.0175 0.0597 6 1.0924 0.0845 6 0.8659* 0.0839 84 TABLE 14 Summary of Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX: GROUP: -- 2-- ------ MAL S -------- -- 3-- -- 4-- -- 5-- -- 6 -- -- 1 --- -- 2-- ----- FEMA LE-------- 3-- -- 4-- -- 5-- -- 6 -- NUMBER: 6 6 6 6 6 56 6 6 6 6 6 LI - LIVER # IN GRP : MEAN: STAND DEV: 6 6.2701 0.7779 6 6.1241 0.4911 6 6.3108 0.4252 6 5.8070 0.8457 6 8.0008* 0.9384 5 9.8193* 0.6974 6 3.9653 0.3785 6 3.8077 0.2222 6 4.0137 0.5071 6 4.1069 0.5175 6 4.7927* 0.2526 6 6.2027* 0.7044 OV - OVARY # IN GRP : 0 0 0 0 0 0 6 6 6 6 6 6 MEAN: 0.0650 0.0663 0.0691 0.0586 0.0581 0.0382* STAND DEV: 0.0114 0.0075 0.0086 0.0130 0.0077 0.0082 SP - SPLEEN # IN GRP : MEAN: STAND DEV: 6 0.3911 0.0264 6 0.3698 0.0453 6 0.3881 0.0648 6 0.3329 0.0479 6 0.3229 0.0593 5 0.2909* 0.0359 6 0.2598 0.0548 6 0.2551 0.0471 6 0.2466 0.0519 6 0.2435 0.0310 6 0.2359 0.0329 6 0.2140 0.0314 TE - TESTIS # IN GRP : 6 6 6 66 50 0 0 0 0 0 MEAN: 1.4847 1.4512 1.4952 1.3776 1.4226 1.5006 STAND DEV: 0.1098 0.1214 0.1644 0.1037 0.0946 0.1628 85 TABLE 14 Summary of Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 3 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX GROUP NUMBER # IN GRP MEAN STAND DEV 6 6 0.2911 0.0722 ------- MALE2 -- -4-- -- 5 -- -- -6 -- 6 666 5 6 TH - THYMUS 6 0.3343 0.0739 6 0.3413 0.0659 6 0.2745 0.0201 6 0.3156 0.0545 5 0.2256 0.0603 6 0.2795 0.0342 - - 2 -- 6 -- 3-- 6 -- 4-- 6 -- 5-- 6 -- 6 -- 6 6 0.2664 0.0704 6 0.2676 0.0440 6 0.2705 0.0352 6 0.2506 0.0856 6 0.2295 0.0474 TT - THYROID/PARATHYR # IN GRP MEAN STAND DEV 6 0.0100 0.0021 6 0.0116 0.0029 6 0.0112 0.0012 6 0.0097 0.0030 6 0.0104 0.0016 5 0.0098 0.0025 6 0.0081 0.0011 6 0.0091 0.0012 5 0.0098 0.0023 6 0.0091 0.0030 6 0.0090 0.0023 6 0.0069 0.0017 TABLE INCLUDES: SEX=ALL; GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN AND KEYWORD (S) OR PHRASE ** TOP OF LIST ** GENERAL COMMENT (GC) ...... MALOCCLUSION NO MACROSCOPIC LESIONS BONE MARROW SMEAR TAKEN ANIMAL THIN DISCHARGE-OCULAR KIDNEY (KD) ............... LARGE PELVIS(ES) LIVER (LI) ..... LARGE LIGHT FOCUS(I)/AREA(S) DIFFUSELY DARK ADRENAL, CORTEX (AC) ... SMALL DIFFUSELY RED TABLE 15 Incidence of Macroscopic Observations Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 -- 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- -5- -6 - -1- -2- -3- -4- -5- -6 - NUMBER: 6 6 6 6 6 5 6 6 6 6 6 ^6 NUMBER EXAMINED: 6 6 6 6 6 5 6 6 6 6 6 6 0 5 6 0 0 0 6 6 0 0 0 5 6 0 0 0 5 6 0 0 0 6 6 0 0 1 0 5 1 1 0 5 6 0 0 0 5 6 0 0 0 5 6 0 0 0 6 6 0 0 0 3 6 0 0 0 5 6 1 0 NUMBER EXAMINED: 6 NOT REMARKABLE: 6 6 6 6 6 6 6 6 6 5 5 66 66 56 6 6 66 66 0 0 0 0 0 0 0 10 000 NUMBER EXAMINED: 6 NOT REMARKABLE: 6 6 6 6 65 6 6 6 63 6 6 6 6 6 6 6 6 6 6 6 6 0 0 0 0 0 0 000 000 00 0 2 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NUMBER EXAMINED: 6 . 6 66 NOT REMARKABLE: 6 6 6 5 65 64 6 6 6 6 6 6 6 6 6 6 6 6 0 01 000 00 0 00 0 0 0 01 000 0 00 TABLE 15 Incidence of Macroscopic Observations Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL N U M B E R - O F -A N IMA L S -A F F E C T E D -- SEX: --- MALE--- -- FEMALE-- GROUP: -1 - -2 - -3- -4- -5- -6 - -1 - -2 - -3- -4- -5- -6 - ORGAN AND KEYWORD(S) OR PHRASE ---- STOMACH, GL (ST) ........... NUMBER: 6 6 6 6 6 5 6 6 6 6 6 6 -=- -=- -=- -=- -=- -=- -=- -=- 6 6 6 6 6 56 6 6 6 6 6 NOT REMARKABLE: 5 6 6 6 6 3 6 6 6 6 6 6 RED FOCUS(I)/AREA(S) DARK FOCUS(I)/AREA(S) 0000 01 00 0000 1 000 01 00 0000 LN, MANDIBULAR (MN) ........ 6 6 6 6 6 56 6 6 6 6 6 NOT REMARKABLE: 6 6 6 6 6 4 6 6 6 6 6 6 MOTTLED 000001 00 0000 SKIN (SK) .................. 6 6 6 6 6 56 6 6 6 6 6 NOT REMARKABLE: 6 6 5 6 6 5 6 6 6 6 6 5 CRUSTED AREA(S) ALOPECIA-FOCAL 001 0 0000 00 00 00000000 0001 UTERUS (UT) ................ 0000 0066 6666 NOT REMARKABLE: 0 0 0 0 0 0 5 6 5 6 3 6 LUMEN FILLED WITH FLUID 0 0 0 0 0 0 1 0 1 0 30 SEMINAL VESICLES (SV) ...... ....... .............. NUMBER EXAMINED: 6 6 6 6 6 5 0 0 0 0 0 0 NOT REMARKABLE: 6 6 6 6 6 4 .0 0 0 0 0 0 SMALL ** END OF LIST ** 0000 01 00 000 0 88 TABLE 16 Incidence of Microscopic Observations Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 1 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL -- N U M B E R - 0 F - A N I M A L S - A F F E C T E D -- SEX: -- MALE -- FEMALE-- GROUP: -1 - -2 - -3- -4- -5- -6 - -- -2 - -3- -4- -5- -6 - ORGAN AND FINDING DESCRIPTION NUMBER: 6 6 6 6 6 6 6 6 6 6 6 6 ** TOP OF LIST ** EYE (EY) ......................................... NUMBER EXAMINED: 6 6 6 6 6 6 6 6 6 6 6 6 NOT REMARKABLE: 6 5 4 6 6 6 6 6 6 6 6 5 --VASCULARIZATION, CORNEAL -- INFILTRATE, LYMPHOCYTIC -- ONE EXAMINED 01 0000000000 0000000 00001 0020000 0000 0 BRAIN (BR) ....................................... NUMBER EXAMINED: 6 6 6 6 6 6 6 6 6 6 6 6 NOT REMARKABLE: 0 0 1 0 0 0 1 0 0 1 1 0 -- VACUOLATION 6 6 56 6 6 56 6 556 KIDNEY (KD) ...................................... NUMBER EXAMINED: 6 6 6 6 6 6 6 6 6 6 6 6 NOT REMARKABLE: 5 2 6 4 5 6 5 3 4 2 5 5 --DEGENERATION, TUBULAR -- HYALINE DROPLETS, TUBULAR EPITHELIUM -- INFLAMMATION, CHRONIC -- PYELITIS -- CYST -- DILATATION, PELVIC 1 0001 001 00 00 1 2 0000000000 02 01 0 00 001 00 01 000001 22 1 1 0001 001 000 0 0 00000001 01 00 LIVER (LI) ....................................... NUMBER EXAMINED: 6 6 6 6 6 6 6 6 6 6 6 6 NOT REMARKABLE: 2 2 3 0 0 0 1 1 4 3 0 0 -- INFLAMMATION, SUBACUTE -- HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR -- VACUOLATION, HEPATOCELLULAR ** CONTINUED ON NEXT PAGE ** 443451 2 0 0 1 3 0 00066 60000 6 6 0 0 0 0 2 0 452 1 2 0 89 TABLE 16 Incidence of Microscopic Observations Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL NUM BER -0 F-AN IMA LS-AFFECTED-- SEX: -- MALE -- FEMALE-- GROUP: -1 - -2 - -3- -4- -5- -6 - -1 - -2 - -3- -4- -5- -6 - ORGAN AND FINDING DESCRIPTION NUMBER: 6 ------- -- -- --- --- _____------- __________- -- __________--- --- --- --=-- 6 --=-- 6 ---- 6 _=- 6 _--_ ** FROM PREVIOUS PAGE ** LIVER (LI) ................................ 66666 NOT REMARKABLE: 2 2 3 0 0 6 6 -=_ 6 _--_ ' _=6_ 66 66 01 1 4 6 _--_6 6 _=_ 6 66 30 0 -- NECROSIS 001 01 30 0 0 1 00 SPLEEN (SP) ............................... 66666 6 6 666 66 NOT REMARKABLE: 6 6 6 6 6 6 6 6 6 6 6 6 PANCREAS (PA) ............................. 66666 66 666 66 NOT REMARKABLE: 6 6 6 6 5 6 6 6 6 6 6 6 -- INFLAMMATION, CHRONIC --HEMORRHAGE 00001 00001 00000 00 0 0 000 00 LN, MESENTERIC (MS) ....................... 6 6 6 6 6 6 6 56 6 6 5 NOT REMARKABLE: 6 6 6 6 6 5 6 5 6 6 6 5 --HEMORRHAGE 000001 0 000 00 ADRENAL, CORTEX (AC) ...................... 66666 66 666 66 NOT REMARKABLE: 4 5 4 5 6 6 6 6 6 6 6 6 -- 'VACUOLATION 2 1 2 1 0 0 0 00 0 00 ADRENAL, MEDULLA (MA) ..................... ...... NUMBER EXAMINED: 6 6 6 6 6 6 6 6 6 6 6 6 NOT REMARKABLE: 6 6 6 6 6 6 6 6 6 6 6 6 90  \ 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1} 1 1 11 1}1 1 1 1 1 1 1 1 1 TABLE 16 Incidence of Microscopic Observations Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 3 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION -- OVARY (OV) .................... TESTIS (TE) ................... BONE, FEMUR (FE) .............. MARROW, FEMUR (FM) ............ MARROW, STERNUM (SE) .......... BONE, STERNUM (SB) ............ LUNG (LU) .................... -- 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- -5- -6 - -1 - -2 - -3- -4- -5- -6 - NUMBER: 6 6 - =" 6 - =- 6 "=- - =-6 6 - =- 6 - =- 6 - =- 66 "=~ "=" 6 - =- 6 - =- 0 000 006 6 66 6 6 NOT REMARKABLE: 0 0 0 0 0 0 6 6 6 6 6 6 6 6 66 6 60 000 00 NOT REMARKABLE: 6 6 6 6 6 6 0 0 0 0 0 0 0 000 0 00 000 00 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0000 000 00000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 00 00 000 000 00 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 00 00 000 0000 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 00 00 0 00 000 00 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 91 TABLE 16 Incidence of Microscopic Observations Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 4 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION MUSCLE, SKELETAL (SM) ............. __n u m b e r - o f - a n i m a l s - a f f e c t e d - SEX: GROUP: -1 - -2 - -3- -4- -5- -6 - -1 - -2 - -3- -4- -5- -6 NUMBER: 6 6 6 6 6 6 6 6 6 6 6 6 ..... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 000 ooo0 0 0 0 0 ..... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 000 oo0 0 0 0 0 ..... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 000 ooo0 0 0 0 0 .... NUMBER EXAMINED: 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0000 ooo0 0 0 ___ NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 000 ooo0 0 0 0 0 STOMACH, GL (ST) -- EROSION STOMACH, NONGL (SU) NUMBER EXAMINED: NOT REMARKABLE: NUMBER EXAMINED: NOT REMARKABLE: o o oo 92 TABLE 16 Incidence of Microscopic Observations Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH riTinr^T,,nunni-pAWTfqm.FONAMIDO ETHANOL (N-MEFOSE, T-6314) IN Ri PAGE: 5 ______________________________ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION --- N U M B E R SEX: GROUP: NUMBER: 6 6 6 0 F -ANIM . 66 -- e ALS- 66 - *" affect -FEMALE--- 66 .. NUMBER EXAMINED: 0 0 0 o 0 o 0 0 o o 0 0 o 0 0 0 0 0 ED-- -666 00 00 .. NUMBER EXAMINED: 0 0 0 o 0 o 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 . NUMBER EXAMINED: 0 0 0 o 0 o 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 .... NUMBER EXAMINED: 0 0 0 0 0 o 0 0 0 o 0 0 0 0 0 0 0 0 0 0 0 0 . NUMBER EXAMINED: 0 0 0 o 0 o 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 .. NUMBER EXAMINED: 0 0 0 o 0 o 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 .. NUMBER EXAMINED: 0 0 0 o 0 o 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 93 TABLE 16 Incidence of Microscopic Observations Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PRPFT.nOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 6 TABLE INCLUDES: SEX=ALL ; GROUP=ALL ; WEEKS=ALL DEATH=ALL ; FIND=ALL ; SUBSET=ALL ORGAN AND FIN D IN G D ESC RIPTIO N THYROID (TY) ............................................... PARATHYROID (P T ) .................................... AORTA (AO) .................................................... PITUITARY ( P I ) ......................................... THYMUS (TH) .................... SPINA L CORD (SC ) HARDERIAN GLAND (HG) -- N U M B E R - 0 F - A N I M A L S - A F F E C T E D -- SEX: GROUP: NUMBER: 6 6 6 6 6 6 6 6 6 6 6 6 NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 0 0 o NOT REMARKABLE: 0 0 0 0 0 0 0 NUMBER EXAMINED: 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NUMBER EXAMINED: 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 o NUMBER EXAMINED: 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NUMBER EXAMINED: 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NUMBER EXAMINED: 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NUMBER EXAMINED: 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 94 l1111111111 111lt111 l1*l111l11 11 ll1l1111111 TABLE 16 Incidence of Microscopic Observations Covance 6329-224 3M T-6314.2 PAGE: 7 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH :N-METHYL .irainni'miHocnT.mNAMTDQ ETHANOL (N-MEFOSE, T-6314) IN Rf ____ __ __________ -- -- ---- -- -- N U M B E R - o F - A N I M A L S - A F F E C T E D -- TABLE INCLUDES : SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION AUDITORY SEB GL (AS) .................. SEX: GROUP: - l - -2 - -3- -4- -5- -6- -1 - -2 - -6- NUMBER: 6 6 6 6 6 6 6 6 6 6 6 6 .. NUMBER EXAMINED: 0 0 0 0 0 0 0 0 o 0 o 0 0 0 0 o 0 0 0 0 0 ... NUMBER EXAMINED: 0 0 0 0 0 0 0 o 0 o 0 0 0 0 0 0 0 0 0 0 0 0 .. NUMBER EXAMINED: 0 0 0 0 0 0 0 o 0 o 0 0 0 0 0 0 0 0 0 0 0 0 -- INVOLUTION, FOLLICULAR -- INFLAMMATION, CHRONIC-ACTIVE MAMMARY, FEMALE (MF) ................. . NUMBER EXAMINED: 0 0 1 0 0Q 0 o 0 0 0 0 0 0 0 0 0 o 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 ___NUMBER EXAMINED: 0 0 0 0 0 0 00 oo 0 0 0 0 00 00 0 0 0 0 URINARY BLADDER (UB) ................ ... NUMBER EXAMINED:: 0 :0 0 0 0 0 0 000 oo0 0 0 0 0 0 0 0 0 95 TABLE 16 Incidence of Microscopic Observations Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 8 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION CERVIX (CV) ................. UTERUS (UT) ................. -- DILATATION VAGINA (VA) ................. PROSTATE (PR) ............... SEMINAL VESICLES (SV) ....... -- SECRETION, DECREASED EPIDIDYMIDES (EP) .......... ** END OF LIST ** ----- N U M B E R - 0 F - A N I M A L s - A F F E C T E D -- SEX: GROUP: NUMBER: 6 6 6 6 6 6 6 6 6 6 6 6 NUMBER EXAMINED: NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NUMBER EXAMINED: NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 10 00 1 0 0 0 30 00 0 0 0 0 0 0 10 1 0 30 NUMBER EXAMINED: NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NUMBER EXAMINED: NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 00 00 0 0 0 00 oo NUMBER EXAMINED: NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 000001 000000 NUMBER EXAMINED: NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 o 96 TABLE 17 Incidence of Severity of Selected Microscopic Observations Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=T ORGAN/TISSUE EXAMINED ** TOP OF LIST ** LIVER (LI) ..... ........ -- INFLAMMATION, SUBACUTE -- HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR -- VACUOLATION, HEPATOCELLULAR --NECROSIS * * END OF LIST ** ___ N U M B E R - O F - A N I M A L S - A F F E C T E D - - SEX GROUP NUMBER ---------- MALE----------- ----------FEMALE-- -2 - -3- -4- -5- -6 - -1- -2- -3- -4- 6666666666 NUMBER EXAMINED-:> 62 1> 4 2> 0 TL> 6 MN> 0.7 6 2 4 0 6 0.7 66 32 33 01 66 0.5 0.8 666 15 4 4 12 10 0 666 1.0 0.2 0.3 6 6 0 0 6 0.0 6 6 0 0 6 0.0 6 66 5 36 13 0 0 00 6 66 0.2 0.5 0.0 -> 6 1> 0 2> 0 3> 0 4> 0 5> 0 TL> 6 MN> 0 . 0 6 0 0 60 05 01 00 0 0 00 4 0 00 2 06 06 06 06 0.0 0.0 1.2 3.3 00 60 00 00 30 36 06 4.5 0.0 6 0 0 0 0 0 6 0.0 6 0 60 00 0 0 0 0 04 02 0 1 0 0 6 00 00 66 5 0 6 0.0 0.0 2.3 3.8 -> 6 1> 0 TL> 6 MN> 0.0 6 0 6 0.0 664 0 6 0 6 2 6 0.0 0.0 0.3 62 1 04 66 5 6 0.0 0.7 0.8 4 5 46 2 12 0 6 6 66 0.3 0.2 0.3 0.0 -> 6 1> 0 3> 0 4> 0 TL> 6 MN> 0 . 0 6 0 0 0 6 0.0 56 10 00 00 66 0.2 0.0 5 1 0 0 6 0.2 3 0 2 1 6 1.7 6 0 0 0 6 0.0 6 0 0 0 6 0.0 6 0 0 0 6 0.0 56 10 00 00 66 0.2 0.0 6 0 0 0 6 0.0 97 APPENDIX 1 Protocol Deviations Protocol Protocol Amendment No. 1 Covance 6329-224 3M T-6314.2 98 Covance 6329-224 3M T -6314.2 Protocol D eviations Protocol. T est m aterial. Disposition o f T est M aterial. A fter authorization from the Sponsor, any remaining test material will be returned to the Sponsor. A ctual P ro ced u re. Remaining test m aterial was retained for future use. Protocol. D osing Procedures. Retention Samples. "Samples (approximately 100 g) will be taken from each dose preparation sampled for dose analyses and stored at room tem perature. Unless used for analyses, these samples will be discarded approxim ately 1 month after com pletion o f the in-life phase. A ctual P ro ced u re. R etention samples w ere not discarded approximately 1 m onth after com pletion o f the in-life phase. Protocol. Term ination. Organ W eights. A t the scheduled sacrifice, thyroid (2) with parathyroid was to be weighed. A ctual P ro ced u re. One thyroid with parathyroid was not weighed for Animal N o. C94539. Protocol. Experim ental Design. Postm ortem Procedures. "The following tissues (when present) will be collected from each animal and preserved in 10% phosphate-buffered formalin." G ross lesions were not to be processed and examined m icroscopically. A ctual P ro ced u re. Some tissues, required by the protocol, were not available for histopathologic examination. 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. Gross lesions were processed and examined microscopically. These deviations are not expected to have affected the results of the study. 99 P ro to c o l C O V /H iii> THE DEVELOPMENT SERVICES COMPANY Sponsor: 3M S t Paul, M innesota PROTOCOL Study Title: 4-W eek Range-Finding Dietary Toxicity Study with N-M ethyl Perfluorooctanesulfonam ido Ethanol (N-MeFOSE, T-6314) in Rats Date: June 8,1998 Performing Laboratory: Covance Laboratories Inc. 3301 Kinsman Boulevard M adison, W isconsin 53704-2595 L ab o rato ry Study Identification: Proposal No. 90545C Covance 6329-224 100 * 4-W eek Range-Finding Dietary ToxicityStudy with N-M ethyl Perfluorooctanesuifonaimdo Ethanol (N-MeFOSE, T-6314) in Rata To assesa the toxicity o f the teat material when administered in the diet to rata for at least 4 weeks Sponsor 3M Toxicology Services Bmlding 220-2E-02, 3M Center St. Paul, M innesota 55144-1000 Study Monitor Andrew M. Seacat, PhD 3M Toxicology Services Telephone No.: 612.575.3161 Facsimile No.: 612.733:1773 Alternate Study Monitor Marvin T. Case, DVM, PhD 3M Toxicology Services Telephone No.: 612.733.5180 Facsimile No.: 612-733:1773 Study Location Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, W isconsin 53704-2595 Mailing Address: PO Box 7545 M adison, Wisconsin 53707-7545 101 Covance 6329-224 Page 3 Study D irector Peter J. Thomford, PhD Covance Laboratories Inc. Telephone No.: 608.241.7207 Facsimile No.: 608.242.2736 T o x ico lo g ist Thomas E. Ryan, BS Covance Laboratories Inc. Proposed Study Timetable In-Life Start Date: June 12,1998 In-Life End Date: July 13,1998 Audited D raft Report Date: October 18,1998 , R egulatory Com pliance ._, This study win be conducted in compliance with the Food and Drug Achuuuutrauon Good Laboratory Practice Regulations as set forth in Title 21 o f the US Code o f Federal Regulations, Part 58, issued December 22,1978 (effective June 20, 1979), and with any applicable amendments. Animal Care and'Use {statement All procedures in this protocol are in compliance with the Animal Welfare Act Regulations, 9 CFR 1-4. In the opinion of the Sponsor and study director, the stu y oes not unnecessarily duplicate any previous work. Quality Assurance The protocol, study conduct, and final report will be audited by the Covance Quality Aocran/^. Unit (QAU). The proliferation ceil nuclear antigen evaluation, data, and repo will be audited by the QAU o f Pathology Associates International. Liver andserum analyses, data, and report will be audited by the QAU of 3M Environmental Technology and Safety Services. 102 m Covance 6329-224 Page 4 Test Material Identification N-Methyl Perfluorooctanesulfonamido Ethanol (MeFOS, T-6314) Lot Number The lot numbers will be maintained in the raw data. Purity Responsibility: of the Sponsor Stability Responsibility o f the Sponsor Storage Conditions A t room temperature C haracteristics Information on synthesis methods, composition, or other characteristics that define the test material is on file with the Sponsor. pp-- 5 -- - " " - -- r rMmf the tem perature. T hese samples will be transferee! to the Sponsor after completion o f the in-life phase. Disposition of TestMaterial After authorization from the Sponsor, any remaining test m aterial will be returned to: Andrew M. Seacat, PhD 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Telephone No.: 612.575.3161 Facsimile No.: 612.733.1773 103 Covance 6329-224 Page 5 Animals Species Rat Strain Crl:CD*(SD) IGS BR Source Charles River Laboratories, Inc., Raleigh, North Carolina Age at lnitiation of Treatment Preferably less than 6 weeks of age, but not more than 8 weeks o f age Weight at Initiation ofTreatment 100 to 300 g Number and Sex 36 males and 36 females Identification Implantable m icrochip identification device Husbandry Individual (may be group-housed during acclimation). Animals will be housed m suspended, stainless steel cages. otherwise specified. The, diet is rouunciy components and environmental contamini analyses are on file at Govance-Madison. 104 Covance 6329-224 Page 6 A d libitum . Samples o f the water are routinely analyzed for specified microorganisms and environmental contaminants. The results are on file at Covance-Madison. Contaminants There are no known contaminants in the diet or water at levels that might interfere w ith this study. dlYUVlUAICMi* . . lfl o p _ Environmental controls for the animal room will be set to maintain 18 to 26 C, a relative humidity of 30 to 70%, and a 12-hour light/12-hour dark cycle. A cclim ation A t least 1 week Selection o f animals for the study will he based on body weights, clinical observanons, and other data as appropriate. Animals will be assigned to treatment groups usmg a com puterized blocking procedure designed to achieve body we,ght balance wrth respect to treatment groups. At the time o f randomization, the weight venation o f the a n L ls o f each sex used will not exceed.*2 standard deviations o f the mean weight, and the mean body weight for each group of:each sex wifi not be starisrically ddferen at the 5.0% probability level. Rats'wstoikmlly have been used in safety evaluation studies and are recommended by appropriate regulatory agencies. 105 Covance 6329-224 _______ Page 7 Group Designations and Dietary Levels Group 1 (Control) 2 (Low) 3 (Low-Mid) 4 (Mid) 5 (Mid-High) 6 (High) Numberof Animals Male Female 66 66 66 66 66 66 Dietary Levels (ppm MeFOS)a 0 1 10 30 100 500 Dose levels are expressed as ppm of MeFOS. b The control animals will receive the basal diet only. Dosing Procedures Method of Administration Dietary, 7 days/week for at least 4 weeks. Treatment will continue through the day before: necropsy. Reason for Dosing Route The potential route o f exposure in humans is oral. developed by Covauce. D ose concentrations will be based on the MeFOS content supplied.. AH dose preparations w ilibe stored at room temperature. Sam ples (approximately 100 g) wfflbe taken from each dose p m p a r a u o n ^ le d for dose analyses andstored at roomtemperature. Unless used or analyses t e e samples will be discarded approximately 1 month after completion o f the m-hfephase. 106 Covance 6329-224 ______Page 8 D ose.Analyses By Covance, using a method supplied by the Sponsor and validated by Covance Homogeneity . Homogeneity wfflbe determinedfor all treated dose level preparations once pretest. One sample each (approximately 100 g) from the top, middle, and bottom o f the dose preparations mixed for homogeneity analyses will be collected, divided into three subsamples for extraction and analysis, and analyzed for test material content. All samples will be stored at room temperature until analyzed. In addition, one samp each (approximately 100 g) from the top, middle, and bottom of the 1-ppm dose preparation mixed for the in-life portion of the study will be collected, divided into three subsamples for extraction and analysis, and analyzed for test material content. Homogeneity analysis will be repeated if batch size changes by more than 30%. Four sets o f samples (approximately 100 g each) wfflbe taken from the low- and high-dose level concentrations of diet preparations mixed pretest. Homogeneity samples collected from the middle of the pretest dose preparations wfflbe analyzed on the day of mixing and used as the baseline value. The remaining samples from lowdose level preparation mixed pretest will be discarded. One sample of the high-dose preparation wffl be stored at room temperature for at least 19 days, then analyzed. The third sample o f the high-dose preparation will be stored at room temperature after at least 32 days, then analyzed. The remaining sample of the high-dose preparation will be stored in a freezer set to maintain ,10 to -30C for 8 weeks, then analyzed. In addition, three samples (approximately 100 g each) wfflbe taken from the low-dose level preparation mixed for the in-life portion o f the study and analyzed according to the schedule used for the samples of pre-test high-dose preparation. Homogeneity samples collected from the middle of the low-dose level preparation will be analyzed on the day o f mixing and used as the baseline value. Dose Confirmation Samples (approximately 100 g) from all dose preparations will be analyzed. Th homogeneity sample collected from the middle of the low-dose level preparation mixed fo r the in-life portion o f the study will be used for dose confirmation. All samples will be stored at room temperature until analyzed. 107 Covance 6329-224 ________ Page 9 Observation of Animals Clinical Observations Each animal will be observed twice daily (a m and p.m.) for mortality and moribundity, recording findings as they are observed. At least once weekly, each ar.nat will be observed (cage will be opened, and the animal will be removed); abnormal findings or an indication of normal will be recorded. Additional findings will be recorded as they are observed. Body Weights Each animal w ill be weighed at least once prior to treatment, on the first day o f treatment, and tw ice weekly thereafter. Food Consumption Food consumption will be recorded for each animal twice weekly during treatment. Clinical Pathology Frequency After a t least 4 weeks o f treatment Number of Animals All Method o f Collection Animals w ill be fasted overnight; blood will be collected from a jugular vein. The anticoagulant will;be potassium EDTA for hematology tests. Urine will be collected chilled overnight (approximately 16 hours). 108 Covance 6329-224 Page 10 Tests Hematology red blood cell (erythrocyte) count hemoglobin hem atocrit mean corpuscular volume rtwan corpuscular hemoglobin mean corpuscular hemoglobin concentration platelet count white blood cell (leukocyte) count differential blood cell count blood cell morphology reticulocyte smear (made, but not examined) Clinical Chemistry glucose urea nitrogen creatinine total protein albumin globulin cholesterol total bilirubin lanine aminotransferase gamma glutamyltransferase aspartate aminotransferase calcium inorganic phosphorus sodium potassium chloride Urinalysis appearance volume specific gravity pH protein urobilinogen glucose ketones bilirubin blood _ m icroscopic examination o f sediment The remaining urine (up to 10 mL) for each animal will stored in a freezer set to mamtam -10 to -30"C. Samples will be packed on dry ice and shipped to: Kris J. Hansen, PhD . 3M Environmental Technology and Safety Services 935 Bush Avenue Building 2-3E-Q9 St. Paul, M innesota 55133-3331 Telephone No.: 612.778.6018 Facsimile No.: 612.778.6176 109 Covance 6329-224 _________ P age H Urine samples will be stored by the Sponsor for possible future analysis. Serum Perfluorooctane Sulfonic Add (PFQS) Analyses Frequency and Number o f Animals Animals will be fasted overnight; blood (approximately 2 mL) will be collected from a jugular vein. Samples will be collected without anticoagulant Sample Handling Blood samples will be allowed to d o t at room temperature and centrifuged. Serum samples will be harvested and stored in a freezer set to maintain -60 to -80C. Samples will be packed on dry ice and shipped to: Kris J. Hansen, PhD 3M Environmental Technology and Safety Services 935 Bush Avenue Building 2-3E-09 S t Paul, Minnesota 55133-3331 Telephone No.: 612.778.6018 Facsimile No.: 612.778.6176 Serum samples will be analyzed for PFOS and metabolites by the Sponsor. Results will be reported separately by the Sponsor. Termination Unscheduled Sacrifices and Deaths Necropsies will be done. Animals to be sacrificed will be anesthetized with carbon dioxide, weighed, and exsanguinated. Scheduled Sacrifice After at least 4 weeks of treatment, all surviving animals will be fasted overnight, bled for fin irai pathology tests and PFOS samples, then anesthetized with carbon dioxide, weighed, exsanguinated, and necropsied. C Postm ortem Procedures Covance 6329-224 ________ Page 12 N ecropsy T he necropsy will include an examination o f the external features o f the carcass; all external body orifices; the abdominal, thoracic, and cranial cavities; organs; and tissues. O rgan W eights At the scheduled sacrifice, the following organs (when present) will be weighed; paired organs will be weighed together: a d ren al(2) brain epididymis (2) kidney (2) liver ovary (2) spleen testis (2) thymus thyroid (2) with parathyroid Organ-to-body weight percentages and organ-to-brain weight ratios will be calculated. Bone M arrow Smear From the femur o f each animal at the scheduled sacrifice only; made but not examined GeU P roliferation T issu e C ollection and Im m unohistochem ical E valu ation At the scheduled sacrifice, representative samples o f left lateral lobe o f the liver from each animal will be collected and preserved in zinc formalin. A fter fixation, each sample o f liver will be embedded in paraffin, and the paraffin blocks will be shipped to: Sandra R. Eldridge, PhD Pathology Associates International 15 W orm an's Mill C ourt, Suite I Frederick, Maryland 21701 Telephone No.: 301.663.1644, ext. 2201 Facsimile No: 301.663.8994 . 111 Covance 6329-224 Page 13 Proliferation cell nuclear antigen (PCNA) evaluation will be done on the samples. Results will be provided for inclusion in the final report. PalmitoyUCoA Oxidase Tissue Collection and Analyses At the scheduled sacrifice, a sample (approximately 500 mg) o f the right lateral lobe o f the liver w ill also be collected from each animal and flash-frozen in liquid nitrogen. The liver tissue will be stored in a freezer set to maintain -60 to -80C until analyzed by Covance for palmitoyl-CoA oxidase activity. Uver rtfu s Analysis . At scheduled sacrifice, a portion o f the liver from each animal will be stored m a freezer set tomaintain -60 to -80C . Sandies will be packed on dry ice and shipped to Kris J. Hansen, PhD, 3M Environmental Technology and Safety Services. Liver samples will be analyzed for PFOS and metabolites by the Sponsor. Results will be reported separately by the Sponsor. Tissue Preservation T h e fbnowing; tissues (when present) from each animal will be preserved in 10% neutral-buffered formalin: adrenal(2) aorta brain cecum cervix colon duodenum esophagus epididymis (2)) eye (2) . fem ur with bone marrow (articular surface o f the distal end) Harderian gland heart . ileum with Peyer's patch (lymphoid aggregate) jejunum kidney (2) lesions liver lung with mainstem bronchi lymph nodes (mesenteric and mandibular) mammary glands (females only) ovary (2) pancreas pituitary prostate rectum salivary gland [mandibular (2.)] sciatic nerve seminal vesicles 112 Covance 6329-224 Page 14 skeletal muscle (thigh) skin . spinal cord (cervical, mid-thoracic, and lumbar) spleen sternum with bone marrow stomach __ testis [(2) preserved in Boum's fixative] thymus thyroid (2) with parathyroid trachea, urinary bladder uterus vagina Zymbal's gland Histopathology ,, The adrenals, brain, eyes, kidneys, liver, mesenteric lymph node, pancreas, n>lTM- testes, and ovaries from each animal will be embedded in paraffin, sectioned, and rifh h(matnxvlin and eosin. Tissue slides will be shipped to: Richard H. Bruner, D.V.M. DAVCP Pathology Associates International Ohio Operations 6217 Centre Park Drive W est Chester, Ohio 45069 Telephone No.: 513.779.9600 Facsimile No.: 513.779.9603 Tissue slides will be examined microscopically by Dr. Bruner and the results from his evaluation will be i n c l u d e d in the final report. After completion o f the examination, slides w ill be returned to Covance-Madison. R eports One copy o f the draft report will be sent to the Sponsor. The report will include the following information: E xperim ental D esign and M ethods R esults dose analyses mortality clinical observations body weights 113 Covance 6329-224 _________ Page 15 body weight changes food consumption test material consumption clinical pathology results organ weights organ-to-body weight percentages organ-to-brain weight ratios paknitoyl GoA oxidase activities macroscopic observations microscopic observations cell proliferation assessments (provided by the Sponsor's designee) Statistical Evaluation Levene's test will be done to test for variance homogeneity. In the case of heterogeneity of variance at p s 0.05, transformations will be used to stabilize the variance. C o m p a r i s o n tests will take variance heterogeneity into consideration. One-way analysis of variance (ANOVA) will be used (if applicable) to analyze body weights, body weight changes, food consumption, continuous clinical pathology values, and organ weight data. If the ANOVA is significant, Dunnett's t-test will be used for control versus treated group comparisons. If the ANOVA shows significance for body weights at Week 1, one-way analysis of covariance (ANCOVA) will be used to analyze body weights, with initial body weights as the covariate. If the ANCOVA is significant, covariate-adjusted means will be used for control versus treated group comparisons. Group comparisons (Groups 2 through 6 versus Group 1) will be evaluated at the 5,0%, two-tailed probability level. Only data collected on or after the first day of treatm ent will be analyzed statistically. At the end o f 1 year after issuance of the audited draft report, if no requested revisions or instructions to finalize have been communicated by the Sponsor, then the audited draft report will be considered'final' and issued as the final report, signed by the study director, and submitted to the Sponsor. Any modifications or changes to the audited draft report requested 1 year after issuance will be performed at additional cost to the Sponsor. 114 I Covance 6329-224 _________ Page 16 Tw o copies o f the signed final report (one unbound and one bound) will be sent to the client. Record Retention All raw data, docum entation, records, protocol, specimens, and final report generated as a result o f this study will be archived in the storage facilities of Covance-M adison for a period of 1 year following submission of the final report to the Sponsor. All raw data stored on m agnetic media, the protocol and protocol amendments, study correspondence, and the original report will be retained by Covance. One year after submission o f the final report, all o f the aforementioned materials will be sent to the Sponsor, and a return fee will be charged. T he Sponsor may elect to have the materials retained in the Covance archives for an additional period o f time, and Covance will charge a storage fee. If the Sponsor chooses to have Covance dispose o f the materials, a disposal fee will be charged. PCNA evaluation data, paraffin blocks, and tissue slides will be retained by Pathology Associates International. Liver, urine, and serum samples sent to the Sponsor and analysis data will be retained by the Sponsor. 115 PROTOCOL APPROVAL Covance 6329-224 _________ Page 17 Andrew M. Seacat, PhD Study M onitor 3M ofahi Date j * Covance Laboratories Inc. 116 Protocol A m endm ent No. 1 T H S D EVELOPMENT 8ERVIC&S COMPANY PROTOCOL AMENDMENT NO. 1 Covance 6329-224 4-Week Range-Finding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Sponsor: Study Monitor: Testing Facility: Study Director: 3M, St. Paul, Minnesota AndrewM. Seacat, PhD Covance Laboratories Inc., Madison, Wisconsin Peter J. Thornford, PhD This amendment modifies the following portions of the protocol: Effective June 8,1998 1. P age 4. To include the vehicle used to dissolve the test material before mixing with the diet, add the following section. Vehicle Identification Acetone Lot Numbers The lot numbers will be maintained in the raw data. Purity On file: with the manufacturer . Stability On file with the manufacturer Storage Conditions At room temperature 117 Covance 6329-224 Protocol Amendment No. 1 Page. 2 C haracteristics Information on synthesis methods, composition, or other characteristics that define the vehicle is on file with the manufacturer. Effective Ju n e 19,1998 2. Page 9, C linical Pathology, M ethod o f Collection To indicate that a different method o f collection is required to provide additional blood, delete the text in this section and replace with the following: Animals will be fasted overnight and anesthetized with carbon dioxide; blood will be collected via cardiac puncture. The anticoagulant will be potassium EDTA for hematology tests. Urine, will be collected chilled overnight (approximately 16 hours). 3. Page 11, Serum Perftoorooctane Sulfonic Acid (FFOS) Analyses, M ethod of C ollection. To indicate that a different method of collection is required to provide additional blood for PFOS analyses, delete the text in this section and replace with the following: Animals will; be fasted overnight and anesthetized with carbon dioxide; blood (as much as possible) will:be collected via cardiac puncture. Samples will be collected without anticoagulant. 4. Page 11, Term ination, Scheduled Sacrifice. To indicate a change in necropsy procedures required for collection of additional blood for PFOS analysis, delete the text in this section and replace with the following; After at least 4 weeks of treatment, all surviving animals will be fasted overnight, then anesthetized w ith carbon dioxide, bled for clinical pathology tests and PFOS samples, weighed, exsanguinated, and necropsied. 118 Covance 6329-224 Protocol Amendment No. 1 _________________________________________________________ Page 3 Effective July 13,1998 5. Page 3, Q uality A ssurance. To indicate that quality assurance for tissue processing will be done by Pathology Associates International, delete the text in this section and replace with the following: The protocol, study conduct, and final report will be audited by the Covance Quality Assurance Unit (QAU). Tissue processing will be audited by the QAU of Pathology Associates International, Ohio Operations. The proliferation cell nuclear antigen evaluation, data, and report will be audited by the QAU of Pathology Associates International, Frederick, Maryland. Liver and serum analyses, data, and report will be audited by the QAU of 3M Environmental Technology and Safety Services. 6. Page 12, Postm ortem Procedures, H istopathology. To reflect the decision to ship tissues to Pathology Associates International for processing, delete the text in this section and replace with the following: Tissue will: be shipped for processing to: Ms. Sheree Lovelace Pathology Associates International Ohio Operations 6217 Centre Park Drive W est Chester, Ohio 45069 The adrenals, brain, eyes, kidneys, liver, mesenteric lymph node, pancreas, spleen, testes, and ovaries from each animal will be embedded in paraffin, sectioned, and stained with hematoxylin and eosin. Tissue slides will be examined microscopically by Richard H. Bruner, D.V.M. DAVCP of Pathology Associates International and the results from his evaluation will be included in the final report. After completion of the examination, slides and tissues wUl be returned to Covance-Madison. 119 Effective July 20,1998 Covance 6329-224 Protocol Amendment No. 1 _________________ Page 4 7. Page 2, Study M onitor and A lternate Study M onitor. To indicate the change in the area code, delete the text in these section and replace with the following: Study M onitor Andrew M; Seacat, PhD 3M Telephone No.: 651.575.3161 FacsiinileNo.: 651.733.1773 A lternate Study M onitor Marvin T. Case, DVM, PhD 3M Toxicology Services Telephone No.: 651.733.5180 Facsimile No.: 651.733.1773 8 P age 4, D isposition o f Test M aterial. To indicate the change in the area code, delete the text in these section and replace with the following: After authorization from the Sponsor, any remaining test material will be returned to: Andrew M. Seacat, PhD 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Telephone No.: 651.575.3161 Facsimile No.: 651.733.1733 9; Page 10, C linical Pathology, Tests, U rinalysis, P aragraph 2. To indicate the change in the area code, delete the text in this paragraph and replace with the following: The remaining urine (up to 10 mL) for each animal will stored in a freezer set to maintain -10 to -30C. Samples will be packed on dry ice and shipped to: Covanee 6329-224 Protocol Am endment No. 1 __________________Page 5 Kris J. Hansen, PhD 3M Environmental Technology and Safety Services 935 Bush Avenue Building 2-3E-09 St. Paul, Minnesota 55133-3331 Telephone No.: 651.778.6018 Facsimile No.: 651.2.778.6176 10. Page 11, Serum Perfhiorooctane Sulfonic Acid (PFOS) Analyses, Sam ple HnmHwtg, Paragraph 1. To indicate the change in the area code, delete the text in this paragraph and replace with the following: Blood samples will be allowed to clot at room temperature and centrifuged. Serum samples will be harvested and stored in a freezer set to maintain -60 to -80C. Samples will be packed on dry ice and shipped to: Kris J. Hansen, PhD 3M Environmental Technology and Safety Services 935 Bush Avenue Building 2-3E-09 St. Paul, Minnesota 55133-3331 Telephone No.: 651.778:6018 Facsimile No.: 651.778.6176 Effective Decem ber 15,1998 11. Page 13, Postm ortem fto ced u res. Cell Proliferation Tissue Collection and Im m unohistochem ieal Evaluation, P aragraph 3* To include examination of liver sections will be stained with hematoxylin and eosin as part of the cell proliferation evaluation, delete this paragraph and replace with the following: Proliferation ce ll nuclear antigen (PCNA) evaluation will be done on the samples. In addition, liver sections will be stained with hematoxylin and eosin and examined microscopically. Results will be provided for inclusion in the final report. 121 Covance 6329-224 Protocol Amendment No. 1 ________________Page 6 AMENDMENT APPROVAL Study Mnitor: 3M D ate/V /i7<?5 APPENDIX 2 Individual Animal Fate D ata Individual Clinical Observations Covance 6329-224 3M T-6314.2 123 APPENDIX 2 Individual Animal Fate Data 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL DOSE NUMBER GROUP C94491 1 C94492 1 C94493 1 C94494 1 C94495 1 C94496 1 C94497 2 C94498 2 C94499 2 C94500 2 C94501 2 C94502 2 C94503 3 C94504 3 C94505 3 C94506 3 C94507 3 C94508 3 C94509 4 C94510 4 C94511 4 C94512 4 C94513 4 C94514 4 C94515 5 C94516 5 C94517 ' 5 C94518 5 C94519 5 C94520 5 C94521 6 C94522 6 C94523 6 C94524 6 SEX MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE DEATH CODE T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T D T TYPE OF DEATH DESCRIPTION OF DEATH SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED UNSCHEDULED SCHEDULED TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE UNSCHEDULED DEATH TERMINAL SACRIFICE DATE OF DAY OF WEEK OF DEATH STUDY STUDY 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/06/98 07/13/98 32 32 32 32 32 32 . 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 25 32 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 4 5 PAGE: 1 124 APPENDIX 2 Individual Animal Fate Data 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL DOSE NUMBER GROUP SEX C94525 C94526 C94527 C94528 C94529 C94530 C94531 C94532 C94533 C94534 C94535 C94536 C94537 C94538 C94539 C94540 C94541 C94542 C94543 C94544 C94545 C94546 C94547 C94548 C94549' C94550 C94551 C94552 C94553 C94554 C94555 C94556 C94557 C94558 6 6 1 1 1 1 1 1 2 2 2 2 2 2 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 6 6 MALE MALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE DEATH CODE T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T TYPE OF DEATH SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED DESCRIPTION OF DEATH TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE DATE OF DAY OF DEATH STUDY 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 07/13/98 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 32 WEEK OF STUDY 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 Covance 6329-224 3M T-6314.2 PAGE: 2 125 APPENDIX 2 Individual Animal Fate Data 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER C94559 C94560 C94561 C94562 DOSE GROUP 6 6 6 6 SEX FEMALE FEMALE FEMALE FEMALE DEATH CODE T T T T TYPE OF DEATH SCHEDULED SCHEDULED SCHEDULED SCHEDULED DESCRIPTION OF DEATH TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE DATE OF DAY OF DEATH STUDY 07/13/98 07/13/98 07/13/98 07/13/98 32 32 32 32 WEEK OF STUDY 5 5 5 5 Covance 6329-224 3M T-6314.2 PAGE: 3 Appendix 2 Individual Clinical Observations 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 1 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: Ml DOSE: 0 PPM C94491 C94492 C94493 C94494 C94495 C94496 T T T T T T 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS DAYS 1-32 - OBSERVED DURING THE DAYS LISTED BELOW; 'C ` - COMMENTS LISTED AT END OF OBSERVATIONS 127 Appendix 2 Individual Clinical Observations 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 2 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M2 DOSE: 1 PPM DAYS 1-32 - OBSERVED DURING THE DAYS LISTED BELOW; 'C' - COMMENTS LISTED AT END OF OBSERVATIONS C94497 C94498 C94499 C94500 C94501 C94502 T T T T T T 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS Appendix 2 individual Clinical observations 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH r,r.nc.rTTnijnnr'TimsnT.pnNAMIDO ETHANOL (N-MEFOSE, i Covance 6329-224 3M T-6314.2 PAGE: 3 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M3 DOSE: 10 PPM DAYS 1-32 OBSERVED DURING THE DAYS LISTED BELOW; C' - COMMENTS LISTED AT END OF OBSERVATIONS^ C94503 T C94504 C94505 C94506 C94507 C94508 T T T T T 5 SKIN & PELAGE SORE/SCAB DORSAL-THORACIC-LEFT DORSAL-THORACIC-RIGHT 5 a ni ma l HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 129 Appendix 2 Individual Clinical Observations 4-WEEK RANGE-FINDING DIETARY T O X IC IT Y STUDY WI T ^-M ETHYL Ts-iTiTT.TfM-inrinrwriRxnjcm.wnNaMTno ETHANOL (N-M EFOSE, T - 6 3 1 4 ) IN RA C o v a n c e 6329-224 3M T-6314.2 PAGE: 4 CATEGORY ANIMAL DEATH WK OF NUMBER CODE DEATH KEYWORD Q U A L IF IE R GROUP: M4 DOSE: 3 0 PPM DAYS 1 - 3 2 - OBSERVED DURING THE DAYS L IS T E D BELOW; _ _ C ` - COMMENTS L IS T E D AT END OF OBSERVATIONS C94509 C94510 C94511 C94512 C94513 C94514 T T T T T T 5 ANIMAL HAS NO SIG N IF IC A N T F IN D IN G S 5 ANIMAL HAS NO SIG N IF IC A N T F IN D IN G S 5 ANIMAL HAS NO SIG N IFIC A N T FIN D IN G S 5 ANIMAL HAS NO SIG N IF IC A N T FIN D IN G S 5 ANIMAL HAS NO SIG N IF IC A N T F IN D IN G S 5 ANIMAL HAS NO SIG N IFIC A N T FIN D IN G S 130 Appendix 2 Individual Clinical Observations 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 5 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M5 DOSE: 100 PPM DAYS 1-32 OBSERVED DURING THE DAYS LISTED BELOW; C' - COMMENTS LISTED AT END OF OBSERVATIONS C94515 C94516 C94517 C94518 C94519 C94520 T T T T T T 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 131 Appendix 2 Individual Clinical Observations 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL {N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 6 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M6 DOSE: 500 PPM DAYS 1-32 - OBSERVED DURING THE DAYS LISTED BELOW; 'C* - COMMENTS LISTED AT END OF OBSERVATIONS C94521 C94522 C94523 C94524 C94525 C94526 T T D T T T 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 4 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS APPENDIX 3 Individual Body Weight D ata (g) Covance 6329-224 3M T-6314.2 133 Covance 6329-224 b 3M T-6314.2 Appendix 3 Individual Body Weight Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 1 ANIMAL DAY DAY NUMBER 1 4 GROUP : MALE 1 - 0 PPM C94491 C94492 C94493 C94494 C94495 C94496 167 181 181 173 153 161 193 204 207 195 178 183 GROUP: MALE 2 - 1 PPM C94497 C94498 C94499 C94500 C94501 C94502 166 170 184 145 175 164 190 192 210 168 201 188 GROUP: MALE 3 - 10 PPM C94503 C94504 C94505 C94506 C94507 C94508 173 188 153 168 157 180 196 210 173 189 179 205 GROUP: MALE 4 - 30 PPM C94509 C94510 C94511 C94512 173 144 156 183 191 165 178 207 DAY 8 226 237 244 234 212 212 228 223 246 198 232 222 235 251 208 219 209 239 224 187 213' 247 DAY 11 248 263 267 257 240 228 252 243 273 221 255 246 258 278 234 246 231 263 245 214 238 270 DAY 15 280 294 290 296 272 255 281 273 309 255 280 274 288 307 269 267 254 293 267 238 261 298 DAY 18 296 315 308 319 295 269 299 289 330 276 298 291 305 328 289 286 270 314 279 249 274 318 DAY 22 325 346 330 354 327 294 329 310 365 304 323 310 334 358 319 314 292 347 300 269 302 348 DAY 25 338 369 347 374 347 306 341 328 387 324 341 328 347 373 340 330 307 360 311 284 312 365 DAY 29 359 389 366 402 369 317 363 342 407 346 352 345 366 393 366 345 321 382 328 305 333 390 DAY 32 347 371 349 388 355 302 355 328 393 331 343 330 351 380 348 334 306 370 312 293 318 376 134 ANIMAL NUMBER DAY DAY 14 GROUP : MALE 4 - 30 PPM C94513 C94514 163 178 185 202 GROUP : MALE 5 - 100 PPM C94515 C94516 C94517 C94518 C94519 C94520 169 154 194 162 156 171 190 172 217 185 179 191 GROUP : MALE 6 - 500 PPM C94521 C94522 C94523 C94524 C94525 C94526 155 176 171 146 164 171 170 194 182 164 173 177 GROUP : FEMALE 1 - 0 PPM C94527 C94528 C94529 C94530 C94531 C94532 139 128 149 145 143 118 154 141 167 161 157 134 Appendix 3 Individual Body Weight Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DAY DAY DAY DAY DAY DAY 8 11 15 18 22 25 219 243 271 290 321 341 236 261 290 305 335 353 222 248 276 292 319 334 201 223 250 261 289 306 249 265 292 310 330 346 213 235 261 279 305 320 213 236 267 281 308 324 225 247 279 293 321 334 188 201 217 226 243 250 203 222 229 251 261 270 203 218 228 236 238 183 197 214 221 215 223 195 215 230 240 248 252 200 213 226 239 254 262 171 178 193 199 205 222 160 175 191 193 211 219 187 197 215 221 235 246 181 191 202 211 230 243 177 189 200 202 219 223 155 165 174 178 193 197 Covance 6329-224 3M T-6314.2 PAGE: 2 DAY DAY 29 32 364 344 378 363 351 340 317 304 363 346 337 325 342 326 351 332 256 236 279 255 236 219 256 239 265 240 239 224 233 217 257 241 253 245 233 215 205 194 135 ANIMAL NUMBER DAY 1 DAY 4 GROUP: FEMALE 2 - 1 PPM C94533 C94534 C94535 C94536 C94537 C94538 130 135 136 125 143 123 146 149 162 146 160 139 GROUP: FEMALE 3 - 10 PPM C94539 C94540 C94541 C94542 C94543 C94544 141 132 158 144 115 120 163 143 182 157 127 133 GROUP: FEMALE 4 - 30 PPM C94545 C94546 C94547 C94548 C94549 C94550 135 130 153 121 141 128 141 150 171 134 150 138 GROUP: FEMALE 5 - 100 PPM C94551 C94552 C94553 C94554 114 146 141 130 129 158 165 142 Appendix 3 Individual Body Weight Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DAY 8 DAY 11 DAY DAY DAY DAY 15 18 22 25 165 172 184 194 206 212 164 176 185 197 209 214 178 179 195 205 219 224 161 171 180 188 205 216 177 184 200 209 225 237 157 165 176 186 196 205 180 188 203 212 225 238 162 170 178 181 186 193 195 201 210 226 241 257 176 202 233 227 236 244 145 151 160 166 174 178 148 156 174 181 189 198 160 169 178 184 192 201 170 180 194 200 217 230 189 201 216 223 240 250 152 160 172 178 186 198 169 183 198 203 216 222 155 170 181 184 196 201 142 149 158 164 176 180 173 184 193 197 208 215 184 194 207 213 220 227 157 167 177 180 192 195 Covance 6329-224 3M T-6314.2 PAGE: 3 DAY 29 DAY 32 227 211 221 207 242 225 225 213 248 231 215 201 243 227 198 185 267 245 256 252 183 178 206 196 209 196 242 228 263 245 208 196 230 216 211 195 189 180 222 211 231 215 204 193 136 ANIMAL DAY DAY NUMBER 1 4 GROUP : FEMALE 5 -- 100 PPM C94555 C94556 124 139 136 152 GROUP : FEMALE 6 -- 500 PPM C94557 C94558 C94559 C94560 C94561 C94562 141 140 114 126 145 144 138 141 121 137 142 146 Appendix 3 Individual Body Weight Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DAY DAY DAY DAY DAY DAY 8 11 15 18 22 25 152 166 176 183 197 206 165 175 186 195 210 215 147 155 164 159 162 172 153 157 162 166 169 171 131 136 138 140 149 149 150 158 166 174 184 191 155 159 171 170 179 182 151 164 169 173 180 179 Covance 6329-224 3M T-6314.2 PAGE: 4 DAY DAY 29 32 215 201 229 213 170 160 176 161 152 140 198 180 188 171 184 171 137 APPENDIX 4 Covance 6329-224 3MT-6314.2 Individual Food Consumption Data (g) Individual Test Material Consumption Data (mg/kg/day) 138 ANIMAL DAY DAY NUMBER 14 GROUP: MALE 1 - 0 PPM C94491 73 99 C94492 74 97 C94493 85 111 C94494 79 108 C94495 70 99 C94496 72 96 GROUP: MALE 2 - 1 PPM C94497 77 107 C94498 73 95 C94499 87 116 C94500 65 94 C94501 78 104 C94502 73 98 GROUP: MALE 3 - 10 PPM C94503 75 105 C94504 75 107 C94505 67 97 C94506 69 93 C94507 68 92 C94508 77 104 GROUP : MALE 4 - 30 PPM C94509 71 98 C94510 65 82 C94511 73 98 C94512 77 106 Appendix 4 Individual Food Consumption Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL {N-MEFOSE, T-6314) IN RATS DAY DAY DAY DAY DAY DAY 8 11 15 18 22 25 76 105 77 104 89 109 85 123 81 111 69 95 85 112 73 102 91 125 73 105 82 106 77 101 81 112 87 113 80 107 77 94 74 96 81 105 73 98 75 94 79 100 84 114 80 105 84 115 80 110 87 117 81 106 87 123 94 122 102 138 82 112 89 116 70 95 76 SPILLED 85 113 86 126 73 97 82 105 94 125 102 135 81 113 89 126 80 104 85 113 78 97 87 186 82 106 86 113 82 108 75 100 72 94 82 107 94 116 92 127 89 120 81 107 78 101 86 120 68 97 66 87 71 99 84 113 75 101 74 98 80 113 88 128 Covance 6329-224 3M T-6314.2 PAGE: 1 139 ANIMAL NUMBER DAY DAY 14 GROUP: MALE 4 - 30 PPM C94513 C94514 68 73 94 98 GROUP : MALE 5 - 100 PPM C94515 68 92 C94516 61 81 C94517 78 102 C94518 71 93 C94519 71 96 C94520 74 101 GROUP: MALE 6 - 500 PPM C94521 C94522 C94523 C94524 C94525 C94526 61 68 68 65 59 62 73 60 78 75 78 77 GROUP: FEMALE 1 - 0 PPM C94527 C94528 C94529 C94530 C94531 C94532 53 67 69 59 63 52 63 79 85 78 85 72 Appendix 4 Individual Food Consumption Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DAY DAY DAY DAY DAY DAY 8 11 15 18 22 25 73 102 77 100 74 98 64 87 74 103 72 97 76 103 77 110 51 72 60 67 58 75 62 80 64 77 65 79 50 77 64 83 61 83 61 78 59 84 54 72 72 100 76 102 81 108 81 110 73 98 63 88 77 98 74 97 75 104 79 105 78 103 72 90 83 115 74 100 81 111 81 107 54 69 52 72 63 70 62 75 54 63 NOT TAKEN 59 57 43 69 59 68 50 66 62 78 64 76 52 66 57 84 57 80 61 92 60 81 64 89 60 84 75 SPILLED 59 79 64 79 59 74 53 68 Covance 6329-224 3M T-6314.2 PAGE: 2 140 ANIMAL DAY DAY NUMBER 1 4 GROUP: FEMALE 2 - 1 PPM C94533 C94534 C94535 C94536 C94537 C94538 57 60 71 62 65 58 77 79 81 74 81 76 GROUP: FEMALE 3 - 10 PPM C94539 C94540 C94541 C94542 C94543 C94544 67 54 76 62 54 48 84 74 85 78 68 56 GROUP: FEMALE 4 -- 30 PPM C94545 C94546 C94547 C94548 C94549 C94550 51 65 67 54 ' 60 52 68 79 87 73 77 70 GROUP: FEMALE 5 - 100 PPM C94551 C94552 C94553 C94554 55 61 62 53 69 75 77 69 Appendix 4 Individual Food Consumption Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DAY DAY DAY DAY DAY DAY 8 11 15 18 22 25 56 76 56 74 59 80 61 80 63 84 60 84 59 87 61 77 66 95 57 72 55 81 68 82 61 85 66 85 69 98 54 75 57 70 57 78 59 76 59 77 62 83 53 70 47 62 53 67 58 78 67 83 71 95 73 106 63 78 64 96 50 69 48 63 52 69 '42 60 44 52 47 72 50 66 48 60 49 66 58 77 58 79 63 81 66 87 64 90 75 SPILLED 55 72 53 71 57 74 62 82 57 80 62 83 58 72 52 67 51 71 52 65 52 85 58 SPILLED 58 73 53 70 54 73 59 77 57 69 56 69 54 70 49 67 49 67 Covance 6329-224 3M T-6314.2 PAGE: 3 141 ANIMAL DAY DAY NUMBER 1 4 GROUP : FEMALE 5 - 100 PPM C94555 C94556 55 60 70 73 GROUP: FEMALE 6 - 500 PPM C94557 C94558 C94559 C94560 C94561 C94562 43 60 48 53 46 54 49 55 54 62 46 49 Appendix 4 Individual Food Consumption Data (g) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DAY DAY DAY DAY DAY DAY 8 11 15 18 22 25 57 73 52 73 57 75 54 72 57 76 57 82 44 54 31 46 40 45 45 53 42 52 41 61 40 44 32 46 33 45 46 63 46 58 49 59 44 60 43 56 44 61 49 SPILLED 52 51 42 55 Covance 6329-224 3M T-6314.2 PAGE: 4 142 ANIMAL DAY DAY NUMBER 1 4 GROUP: MALE 2 - 1 PPM C94497 C94498 C94499 C94500 C94501 C94502 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 GROUP: MALE 3 - 10 PPM C94503 C94504 C94505 C94506 C94507 C94508 1.4 1.2 1.3 1.2 1.4 1.3 1.3 1.1 1.3 1.2 1.3 1.2 GROUP: MALE 4 - 30 PPM C94509 C94510 C94511 C94512 C94513 C94514 3.9 3.5 4.2 3.5 4.4 3.8 3.9 3.5 3.9 3.5 3.8 3.4 GROUP: MALE 5 - 100 PPM C94515 C94516 C94517 C94518 12.6 12.5 12.7 13.6 11.2 10.9 10.9 11.7 Appendix 4 Individual Test Material Consumption Data (mg/kg/dy) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DAY DAY DAY DAY DAY DAY 8 11 15 18 22 25 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 1.1 1.0 0.9 0.8 0.9 0.8 1.1 1.0 0.9 0.8 0.8 0.8 1.2 1.1 1.0 0.9 0.9 0.8 1.1 0.9 0.9 0.8 0.8 0.8 1.1 1.0 0.9 0.8 0.9 0.8 1.1 0.9 0.9 0.8 0.8 0.8 3.1 2.9 2.5 2.5 2.5 2.4 3.7 3.1 2.7 2.5 2.7 2.5 3.5 3.0 2.7 2.6 2.6 2.6 3.2 3.0 2.7 2.5 2.5 2.5 3.2 3.0 2.6 2.5 2.4 2.3 3.1 2.7 2.6 2.4 2.4 2.3 10.5 9.4 8.6 8.0 8.0 7.5 10.1 9.2 8.2 8.0 8.1 7.2 9.6 9.2 8.5 7.7 8.2 8.1 10.7 9.8 9.1 8.3 7.9 7.6 Covance 6329-224 3M T-6314.2 PAGE: 1 143 Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL DAY DAY NUMBER 1 4 GROUP: MALE 5 - 1 0 0 PPM C94519 C94520 14.1 13.6 12.2 12.1 GROUP: MALE 6 - 500 PPM C94521 C94522 C94523 C94524 C94525 C94526 62.6 61.3 64.2 69.9 58.4 59.4 51.0 37.8 50.6 54.0 53.0 51.1 GROUP: FEMALE 2 - 1 PPM C94533 C94534 C94535 C94536 C94537 C94538 0.1 0.1 0.1 0.1 0 . 2 0.1 0 . 2 0.1 0.1 0.1 0.1 0.1 GROUP: FEMALE 3 - 1 0 PPM C94539 C94540 C94541 C94542 C94543 C94544 1.5 1.3 . 1.5 1.4 1.5 1.3 1.2 1.2 1.1 1.2 1.3 1.0 DAY 8 11.3 10.9 43.7 47.1 45.9 54.4 52.0 52.5 0.1 0.1 0.1 0.1 0.1 0.1 1.1 1.1 1.0 1.3 1.1 0.9 DAY 11 10.2 10.5 43.1 37.1 42.0 48.7 43.3 45.0 0.1 0.1 0.1 0.1 0.1 0.1 1.0 1.0 0.9 1.2 1.1 0.9 DAY 15 9.1 9.2 40.6 43.8 38.8 45.2 41.8 44.4 0.1 0.1 0.1 0.1 0.1 0.1 0.9 0.9 1.0 0.9 1.0 0.8 DAY 18 DAY 22 DAY 25 8 . 8 8.5 8.3 8 . 6 8 . 2 7.8 36.8 34.2 33.2 32.7 34.8 39.6 35.2 38.9 NOT TAKEN 32.7 33.3 41.3 35.6 34.2 NOT TAKEN 37.6 32.5 36.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.9 0.9 0.9 0 . 8 0.9 0.9 0.9 1.0 0.9 0 . 8 0.9 1.0 0.9 1.0 1.0 0.7 0 . 8 0.9 Covance 6329-224 3M T-6314.2 PAGE: 2 144 Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL DAY DAY NUMBER 1 4 GROUP: FEMALE 4 - 30 PPM C94545 C94546 C94547 C94548 C94549 C94550 3.7 3.4 4.6 3.7 4.1 3.6 4.2 3.8 4.1 3.6 3.9 3.6 GROUP: FEMALE 5 -- 100 PPM C94551 C94552 C94553 C94554 C94555 C94556 15.1 13.4 13.5 13.0 14.1 13.7 12.7 11.3 11.0 11.5 12.2 11.5 GROUP : FEMALE 6 -- 500 PPM C94557 C94558 C94559 C94560 C94561 C94562 51.4 71.2 68.1 ' 67.2 53.4 ' 62.1 43.0 46.8 53.6 54.0 38.7 41.2 DAY DAY 8 11 3.0 2.9 3.3 3.1 3.4 3.1 3.5 3.3 3.5 3.2 3.6 3.1 11.9 10.8 10.4 11.1 11.9 10.6 10.6 9.7 9.6 10.2 10.7 10.0 48.6 48.4 49.9 49.8 46.7 51.9 42.3 41.5 40.1 48.6 45.5 SPILLED DAY 15 2.7 2.9 2.9 3.0 2.8 2.8 10.8 9.1 9.0 9.2 9.7 10.0 32.0 42.7 38.4 45.1 42.0 50.7 DAY 18 2.4 2.8 2.9 2.9 2.9 2.6 12.5 8.6 8.0 9.0 9.6 9.4 35.8 38.8 39.8 40.5 40.1 36.1 DAY 22 DAY 25 2.5 2.4 2.8 2.6 3.1 SPILLED 3.0 2.7 2.8 2.8 2.6 2.6 10.9 8.5 8.4 8.4 9.4 8.9 SPILLED 8.4 7.5 8.4 8.9 9.2 39.9 40.2 36.9 43.6 40.6 39.0 32.9 43.9 37.4 37.9 41.2 37.9 Covance 6329-224 3M T-6314.2 PAGE: 3 145 APPENDIX 5 Individual Clinical Hematology Data Individual Clinical Chemistry Data Individual Clinical Urinalysis Data Covance 6329-224 3M T-6314.2 Appendix 5 ANIMAL NUMBER Individual Clinical Hematology Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC HGB HCT MCV MCH MCHC PLT X106/*IL G/DL % FL PG % XlOVjlL Group: i C94491 C94492 C94493 C94494 C94495 C94496 MEAN S.D. N Group: 2 C94497 C94498 C94499 C94500 C94501 C94502 MEAN S.D. N Group: 3 C94503 C94504 C94505 C94506 C94507 C94508 MEAN S.D. N Dose Level: 0 7.82 7.56 7.47 6.91 6.61 7.39 15.3 15.5 14.9 14.9 13.9 15.3 7.29 .448 6 15.0 .58 6 Dose Level: 1 7.43 7.06 7.09 7.23 7.68 7.55 15.0 15.0 14.5 13.6 15.2 14.6 7.34 .253 6 14.6 .58 6 Dose Level:: 1 0 6.96 7.06 7.41 7.44 ' 7.44 7.31 14.2 15.1 15.2 14.9 14.5 15.3 7.27 .209 6 14.9 .43 6 Dosage Unit: ppm MeFOS 45.6 46.4 44.8 43.7 41.2 45.7 58.2 61.4 60.0 63.3 62.3 61.9 19.6 20.5 20.0 21.6 21.0 20.8 44.6 1.89 6 61.2 1.82 6 20.6 .72 6 Dosage Unit: ppm MeFOS 45.3 44.4 42.6 40.5 46.2 45.3 61.0 62.9 60.0 56.0 60.2 60.0 20.2 21.3 20.4 18.9 19.8 19.4 44.1 2.12 6 60.0 2.26 6 20.0 .84 6 Dosage Unit: ppm MeFOS 42.0 44.3 45.3 44.0 43.1 45.2 60.3 62.8 61.1 59.2 58.0 61.9 20.5 21.4 20.6 20.0 19.4 20.9 44.0 1.27 6 60.6 1.76 6 20.5 .70 6 33.6 33.4 33.3 34.1 33.8 33.5 33.6 .29 6 33.2 33.9 34.1 33.7 32.9 32.3 33.4 .68 6 33.9 34.1 33.7 33.8 33.5 33.8 33.8 .20 6 1220 985 940 989 986 808 988 133. 6 969 1170 949 1301 877 1079 1058 157 6 1139 1036 1204 1012 899 977 1044 110 6 Covance 6329-224 3M T-6314.2 147 Appendix 5 ANIMAL NUMBER Individual Clinical Hematology Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC HGB HCT MCV MCH MCHC PLT x i o V jil G/DL % FL PG % x io V ul Group: 4 C94509 C94510 C94511 C94512 C94513 C94514 MEAN S.D. N Group : 5 C94515 C94516 C94517 C94518 C94519 C94520 MEAN S.D. N Group : 6 C94521 C94522 C94524 C94525 C94526 MEAN S.D. N Dose Level : 30 7.53 7.38 7.63 7.39 7.25 7.23 15.1 15.0 15.3 15.6 14.5 14.5 7.40 .156 6 15.0 .44 6 Dose Level: 1 0 0 6.08 6.40 7.99 6.86 7.61 7.08 12.9 14.1 16.2 14.5 15.3 14.3 7.00 .719 6 14.6 1.12 6 Dose Level: 500 5.18 6.57 5.63 5.58 6.54 11.8 13.5 11.6 11.3 13.2 5.90 .623 5 12.3 1.00 5 Dosage Unit: ppm MeFOS 44.0 45.2 45.7 45.5 43.2 43.6 58.4 61.2 59.9 61.6 59.5 60.3 20.0 20.3 20.0 21.1 20.0 20.1 44.5 1.07 6 60.2 1.16 6 20.2 .43 6 Dosage Unit: ppm MeFOS 38.3 40.9 47.9 43.0 46.0 42.4 62.9 63.8 60.0 62.8 60.5 59.8 21.2 22.0 20.3 21.1 20.1 20.2 43.1 3.46 6 61.6 1.73 6 20.8 .75 6 Dosage Unit: ppm MeFOS 33.6 39.3 34.1 33.5 39.5 64.8 59.9 60.5 60.0 60.4 22.8 20.5 20.6 20.3 20.1 36.0 3.11 5 61.1 2.07 5 20.9 1.10 5 34.2 33.2 33.4 34.3 33.7 33.3 33.7 .47 6 33.8 34.4 33.8 33.6 33.2 33.8 33.8 .39 6 35.1 34.3 34.0 33.8 33.3 34.1 .67 5 1009 770 1016 1121 1116 1310 1057 177 6 1052 1069 1114 1251 894 1306 1114 148 6 1059 899 677 1069 1132 967 183 5 Covance 6329-224 3M T-6314.2 148 ANIMAL NUMBER WBC X103/HL Appendix 5 Individual Clinical Hematology Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH xio3/hl X103/HL MONO EOSIN x i o 3/hl x io3/hl BASO N--SEG% x io3/hl LYMPH% MONO% Covance 6329-224 3M T-6314.2 EOSIN% BASO% Group: 1 C94491 C94492 C94493 C94494 C94495 C94496 MEAN S.D. N Group: 2 C94497 C94498 C94499 C94500 C94501 C94502 MEAN S.D. N Group: 3 C94503 C94504 C94505 C94506 C94507 C94508 MEAN S.D. N Dose Level : 0 14.7 11.2 13.6 13.3 6.0 10.5 .8 1.2 1.3 1.7 .5 .8 11.6 3.14 6 1.0 .43 6 Dose Level : 1 7.4 9.1 11.9 16.7 14.5 10.8 1.0 1.0 1.4 2.8 .8 1.1 11.7 3.43 6 1.4 .74 6 Dose Level : 1 0 15.8 18.4 11.2 16.2 5.2 15.1 2.2 1.0 1.3 2.1 1.0 1.0 13.6 4.76 6 1.4 .57 6 Dosage Unit: ppm MeFOS 12.5 9.3 10.9 10.3 5.4 8.1 1.2 .6 .9 1.1 .2 1.4 .1 .1 .5 .2 .0 .2 9.4 .9 . 2 2.46 .44 .17 666 Dosage Unit: ppm MeFOS 6.0 7.7 9.5 12.3 12.6 8.7 .4 .4 .8 1.5 .9 .8 .1 .1 .1 .0 .1 .1 9.5 . 8 .1 2.59 .40 .04 6 66 Dosage Unit: ppm MeFOS 12.3 16.4 9.1 12.9 3.2 13.4 1.2 .7 .7 .9 .9 .6 .2 .2 .1 .3 .0 .1 11.2 .8 .2 4.57 . 2 2 . 1 0 666 .1 .0 .0 .0 .0 .0 .0 .04 6 .0 .0 .0 .1 .0 .0 .0 .04 6 .0 .1 .0 .0 .0 .0 .0 .04 6 6 10 9 13 8 7 9 2 .5 6 13 11 12 17 6 10 12 3.. 6 6 14 6 12 13 20 7 12 5. 1 6 85 83 80 78 89 77 82 4. 6 6 80 84 80 74 87 81 81 4. 4 6 78 89 81 80 62 89 80 9..9 6 8 6 7 8 3 14 8 3. 6 6 6 4 7 9 6 7 6 1 .6 6 7 4 6 6 16 4 7 4..5 6 1 1 3 1 0 2 1 1.0 6 1 0 0 0 0 0 0 6 1 1 1 0 1 1 1 .4 6 0 0 0 0 0 0 0 6 1 1 1 2 1 1 1 .4 6 0 0 0 0 1 0 0 6 149 ANIMAL NUMBER Group: 4 C94509 C94510 C94511 C94512 C94513 C94514 MEAN S.D. N Group: 5 C94515 C94516 C94517 C94518 C94519 C94520 MEAN S.D. N Group: 6 C94521 C94522 C94524 C94525 C94526 MEAN S.D. N WBC XlOVtlL Appendix 5 Individual Clinical Hematology Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH X103/|1L XIOVU-L MONO EOSIN X103/|1L x io 3/hl BASQ N-SEG% x i o 3/h l LYMPH% MONO% Covance 6329-224 3M T-6314.2 EOSIN% BASO% Dose Level : 30 Dosage Unit: ppm MeFOS 13.3 .7 11.6 .7 .2 .0 13.1 .7 11.6 .6 .2 .0 10.6 .7 8.5 1.3 .1 .0 13.1 1.1 10.9 1.0 11.2 .8 9.8 .6 .1 .1 .0 .0 12.4 .8 11.0 .4 .1 .0 12.3 1.13 6 .8 10.6 .15 1.21 66 .8 .33 6 .1 .05 6 .0 .00 6 5 88 5 5 89 5 6 80 12 8 84 7 7 87 6 89 5 4 6 86 1..2 3.,5 66 6 2..9 6 11 00 10 10 1 1 00 10 .0 66 Dose Level : 100 Dosage Unit: ppm MeFOS 13.4 1.4 11.3 .6 .1 .0 10 85 4 10 10.9 1.0 9.6 .2 .1 .0 9 88 2 1 0 18.6 1.4 15.5 1.5 .1 .1 8 83 8 10 13.4 1.0 12.1 .2 .1 .0 12.5 .7 11.0 .7 .1 .0 7 90 6 88 9.0 1.1 7.3 .5 .1 .0 12 81 2 5 5 10 10 10 13.0 1.1 11.1 .6 .1 .0 3.24 .27 2.72 .48 .00 .04 666666 9 86 4 1 0 2.2 3.,4 2.,3 .0 6 6 6 66 Dose Level : 500 Dosage Unit: ppm MeFOS 9.8 .7 8.7 .4 .0 .0 7 89 12.5 8.1 2.3 .7 9.1 7.1 1.0 .3 .0 .1 .1 .0 18 73 8 88 4 8 3 00 01 10 11.6 .6 10.3 .6 .0 .0 5 89 5 0 0 9.8 2.0 7.0 .7 .0 .0 21 72 7 0 0 10.4 1.3 8.4 .6 .0 .0 12 82 5 0 0 1.72 .82 1.40 .27 .04 .04 7.,2 8.,9 2.,1 4 5 5 5 5 5 5 5 5 5 55 150 Appendix 5 Individual Clinical Hematology Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group : 1 C94491 C94492 C94493 C94494 C94495 C94496 Group : 2 C94497 C94498 C94499 C94500 C94501 C94502 Group: 3 C94503 C94504 C94505 C94506 C94507 C94508 Group: 4 C94509 C94510 C94511 C94512 C94513 C94514 Dose Level : 0 Dose Level : 1 Dose Level: 10 Dose Level: 30 Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS 151 Covance 6329-224 3M T-6314.2 Appendix 5 Covance 6329-224 3M T-6314.2 Individual Clinical Hematology Data Males Week 5 'I 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 5 C94515 C94516 C94517 C94518 C94519 C94520 Group: 6 C94521 C94522 C94524 C94525 C94526 Dose Level: 100 ------------- Dose Level: 500 ----------- Dosage Unit: ppm MeFOS ------- Dosage Unit: ppm MeFOS ------ Appendix 5 ANIMAL NUMBER Individual Clinical Hematology Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC HGB HCT MCV MCH MCHC PLT x i o 6/hl G/DL % FL PG % x io 3/*il Group: 1 C94527 C94528 C94529 C94530 C94531 C94532 MEAN S.D. N Group: 2 C94533 C94534 C94535 C94536 C94537 C94538 MEAN S.D. N Group: 3 C94539 C94540 C94541 C94542 C94543 C94544 MEAN S.D. N Dose Level: 0 6.11 6.96 7.65 6.86 7.77 7.37 13.8 14.6 15.6 14.3 15.1 15.1 7.12 .613 6 14.8 .65 6 Dose Level: 1 7.65 7.82 7.11 7.28 7.56 7.03 16.0 15.7 14.9 15.2 15.4 14.6 7.41 .316 6 15.3 .51 6 Dose Level: 10 8.09 6.98 7.43 8.11 7.83 7.25 17.0 14.7 15.3 16.4 15.6 14.6 7.62 .466 6 15.6 .95 6 Dosage Unit: ppm MeFOS 40.5 43.4 46.1 41.6 45.1 44.2 66.2 62.3 60.2 60.7 58.1 59.9 22.6 21.0 20.4 20.8 19.4 20.5 43.5 2.12 6 61.2 2.78 6 20.8 1.05 6 Dosage Unit: ppm MeFOS 46.5 45.7 44.4 44.7 46.0 42.8 60.7 58.5 62.4 61.5 60.9 60.9 20.9 20.1 21.0 20.9 20.4 20.8 45.0 1.34 6 60.8 1.29 6 20.7 .35 6 Dosage Unit: ppm MeFOS 49.8 44.8 45.9 48.5 46.1 43.5 61.6 64.1 61.8 59.8 58.9 60.0 21.0 21.1 20.6 20.2 2200..02 46.4 2.34 6 61.0 1.87 6 20.5 .46 6 34.2 33.8 33.9 34.3 33.4 34.2 34.0 .34 6 34.4 34.3 33.7 34.0 33.5 34.2 34.0 .35 6 34.1 32.9 33.4 33.7 34.0 33.6 33.6 .44 6 939 1072 979 1031 903 1148 1012 90.3 6 1226 974 1109 921 898 904 1005 133.7 6 1041 830 919 1156 1065 845 976 131.4 6 Covance 6329-224 3M T-6314.2 153 Appendix 5 ANIMAL NUMBER Individual Clinical Hematology Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC HGB HCT MCV MCH MCHC PLT x i o 6/hl G/DL % FL PG % XIOVilL Group: 4 C94545 C94546 C94547 C94548 C94549 C94550 MEAN S.D. N Group: 5 C94551 C94552 C94553 C94554 C94555 C94556 MEAN S.D. N Group: 6 C94557 C94558 C94559 C94560 C94561 C94562 MEAN S.D. N Dose Level: 30 7.11 7.09 7.17 7.07 6.97 7.73 14.7 14.5 14.9 14.5 14.6 15.8 7.19 .272 6 14.8 .50 6 Dose Level: 100 7.45 7.22 7.33 6.87 8.05 7.46 14.8 14.8 14.8 14.4 16.1 14.9 7.40 .386 6 15.0 .58 6 Dose Level: 500 5.96 6.34 6.12 6.09 6.53 7.00 6.34 .381 6 12.4 12.3 11.1 12.6 13.1 14.4 12.6 1.08 6 Dosage Unit: ppm MeFOS 42.8 42.2 42.9 43.0 42.6 47.1 60.1 59.5 59.7 60.8 61.1 60.9 20.6 20.5 20.7 20.5 21.0 20.5 43.4 1.82 6 60.4 .67 6 20.6 .20 6 Dosage Unit: ppm MeFOS 43.4 43.0 44.0 42.8 47.2 44.2 44.1 1.61 6 58.2 59.5 60.1 62.3 58.6 59.2 59.6 1.46 6 19.9 20.5 20.2 21.0 19.9 19.9 20.2 .45 6 Dosage Unit: ppm MeFOS 35.6 36.6 31.6 37.1 37.9 42.3 59.7 57.8 51.7 60.9 58.0 60.4 20.8 19.5 18.2 20.7 20.1 20.6 36.8 3.47 6 58.1 3.37 6 20.0 1.00 6 34.3 34.4 34.7 33.7 34.3 33.6 34.2 .43 6 34.1 34.5 33.7 33.7 34.1 33.6 33.9 .34 6 34.9 33.7 35.2 34.0 34.6 34.1 34.4 .58 6 934 1058 1021 950 1106 1092 1027 72 6 1016 1061 1228 1075 1165 871 1069 123 6 759 1027 1057 1091 1255 1065 1042 160 6 Covance 6329-224 _3M T-6314.2 154 ANIMAL NUMBER Group: 1 C94527 C94528 C94529 C94530 C94531 C94532 MEAN S.D. N Group: 2 C94533 C94534 C94535 C94536 C94537 C94538 MEAN S.D. N Group: 3 C94539 C94540 C94541 C94542 C94543 C94544 MEAN S.D. N WBC X103/HL Appendix 5 Individual Clinical Hematology Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH x i o 3/hl x io V jil MONO EOSIN BASO N--SEG% X lo V jlL X103/JiL xio3/jil LYMPH% MONO% Covance 6329-224 3M T-6314.2 EOSIN% BASO% Dose Level : 0 Dosage Unit: ppm MeFOS 5.6 1.2 4.1 .2 2.8 .2 2.5 .1 12.0 .5 9.4 2.0 7.4 .6 5.8 .9 5.0 10.0 .6 4.2 .5 8.8 .2 .6 .1 .0 .1 .1 ..11 .0 21 74 4 .0 9 88 2 .1 4 78 17 .0 8 79 12 .0 11 84 4 .0 5 88 6 10 11 00 1 1 00 10 7.1 .6 5.8 .7 .1 .0 10 82 8 1 0 3.40 .33 2.77 .72 .04 .04 666666 6.1 5.7 5.8 .0 6 6 6 66 Dose Level : 1 Dosage Unit: ppm MeFOS 12.1 .8 10.8 .4 .1 .0 4.4 .2 3.8 .4 .0 .0 7 90 5 86 3 8 10 00 8.5 .9 7.1 .3 .2 .0 11 84 3 2 0 4.3 .3 3.7 .2 .0 .0 8 86 5 1 0 5.7 13.1 .9 4.3 .4 12.0 .4 .6 ..01 ..00 16 3 76 92 7 5 10 00 8.0 .6 7.0 .4 .1 .0 ' 3.87 .32 3.68 .13 .08 .00 666666 8 86 5 1 0 4..6 5..6 2..0 .8 6 6 6 66 Dose Level : 10 Dosage Uni t: ppm MeFOS 12.3 1.2 9.8 1.2 .1 .0 10 80 10 10 5.4 .4 4.5 .5 .1 .0 7 84 8 10 9.9 .5 8.4 .8 .1 .0 5.3 .4 4.7 .1 .1 .0 5 85 8 88 8 10 2 10 9.2 .4 8.3 .4 .1 .0 4 90 4 1 0 5.6 .3 4.8 .5 .0 .0 8.0 .5 6.8 .6 .1 .0 2.94 6 .33 2.34 66 .38 6 .04 6 .00 6 6 85 8 1 0 7 85 2,.2 3,.4 7 3..0 1.01 0 6 6 6 66 155 ANIMAL NUMBER Appendix 5 WBC X103/|1L Individual Clinical Hematology Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH MONO EOS IN BASO N- SEG% xio3/hl Xl03/JiL X103/HL X103/HL XlO/H-L LYMPH% MONO% Covance 6329-224 3M T-6314.2 EOSIN% BASO% Group: 4 Dose Level : 30 Dosage Unit: ppm MeFOS C94545 C94546 C94547 11.3 15.1 1.7 8.8 .6 13.6 .7 .8 .1 .1 .0 .0 15 78 4 90 12.5 1.0 10.8 .6 .1 .0 8 86 6 5 5 11 00 10 C94548 C94549 C94550 5.2 9.7 .2 4.8 .9 8.4 .1 .4 .1 .1 .0 .0 14.0 .9 12.5 .5 .1 .0 4 93 9 86 6 90 2 4 3 10 1 1 00 MEAN S.D. N 11.3 3.55 .9 9.8 .50 3.18 .5 .25 .1 .00 .0 .00 6 66 666 8 87 4 1 0 4.1 5.2 1..5 .0 6 6 6 66 Group: 5 C94551 C94552 C94553 C94554 C94555 C94556 MEAN S.D. N Dose Level : 100 12.1 13.6 12.1 7.0 15.3 9.5 .6 .7 .6 .5 .6 .5 11.6 2.96 6 .6 .08 6 Dosage Unit: ppm MeFOS 10.5 .8 12.8 .1 11.1 .4 6.2 .3 14.2 7.9 .3 1.0 .1 .0 .1 ..01 .1 10.4 .5 .1 2.99 .34 .05 6 66 .0 .0 .0 .0 .0 .0 .0 .00 6 5 87 5 94 7 1 5 91 3 7 88 5 4 93 2 6 83 10 5 89 1.,0 4..1 66 5 3.,4 6 10 00 10 10 10 10 10 .4 66 Group: 6 Dose Level : 500 Dosage Unit: ppm MeFOS C94557 C94558 C94559 C94560 C94561 C94562 9.0 9.5 13.5 .4 8.3 1.1 8.1 .6 12.3 .3 .3 .5 .0 .0 .0 .0 .0 .0 4 92 11 85 5 91 17.2 .6 16.4 .2 .0 .0 3 95 13.3 6.2 .5 ' 12.1 .3 5.7 ..62 .0 .0 ..10 4 91 5 91 3 3 4 1 5 3 00 00 00 00 00 00 MEAN S.D. N 11.4 .6 10.5 .4 .0 .0 3.95 6 .28 3.85 66 .16 6 .00 6 .04 6 5 91 3 0 0 2.9 3..3 1..3 .0 6 6 6 66 156 Appendix 5 Individual Clinical Hematology Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 1 C94527 C94528 C94529 C94530 C94531 C94532 Group: 2 C94533 C94534 C94535 C94536 C94537 C94538 Group: 3 C94539 C94540 C94541 C94542 C94543 C94544 Group: 4 C94545 C94546 C94547 C94548 C94549 C94550 Dose Level: 0 Dose Level: 1 Dose Level: 10 ----------- Dose Level: 30 ___ ------___ --- Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS - ----- - Dosage Unit: ppm MeFOS __ ---__ -- 157 Covance 6329-224 3M T-6314..2 Appendix 5 Individual Clinical Hematology Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 5 C94551 C94552 C94553 C94554 C94555 C94556 Group: 6 C94557 C94558 C94559 C94560 C94561 C94562 Dose Level: 100 Dose Level: 500 1 Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Covance 6329-224 3M T-6314.2 158 Appendix 5 ANIMAL NUMBER Group: 1 C94491 C94492 C94493 C94494 C94495 C94496 MEAN S.D. N Group : 2 C94497 C94498 C94499 C94500 C94501 C94502 MEAN S.D. N Group : 3 C94503 C94504 C94505 C94506 C94507 C94508 MEAN S.D. N Individual Clinical Chemistry Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL Dose Level: 0 Dosage Unit: ppm MeFOS 140 194 15 14 .5 6.3 4.6 1.7 .8 6.4 4.8 1.6 .3 .2 56 50 211 13 .5 5.6 4.1 1.5 .0 49 149 111 16 13 .8 6.3 4.6 1.7 .5 6.2 4.7 1.5 .2 .1 56 33 127 12 .7 6.0 4.3 1.7 .1 37 155 14 .6 6.1 4.5 1.6 .2 47 39.1 1.5 .15 .29 .26 .10 .10 9. 7 666666 66 Dose Level: 1 Dosage Unit: ppm MeFOS 133 15 1.0 6.3 4.5 1.8 .1 43 124 10 .6 6.9 5.0 1.9 .0 80 165 16 .7 6.3 4.5 1.8 .0 56 139 11 .4 5.8 4.2 1.6 .2 48 123 12 .5 6.3 4.7 1.6 .2 48 124 15 .7 6.3 4.6 1.7 .2 56 135 16.2 13 2.5 .6 .21 6.3 .35 4.6 .26 1.7 .12 666666 .1 55 .10 13. 2 66 Dose Level: 10 Dosage Unit: ppm MeFOS 129 12 197 11 137 15 128 10 98 13 136 13 .5 6.2 4.4 1.8 .6 6.4 4.6 1.8 .9 6.2 4.4 1.8 .3 5.9 4.4 1.5 .7 6.0 4.6 1.4 .5 6.0 4.4 1.6 .2 43 .0 28 .4 40 .0 65 .3 37 .2 50 138 32.5 6 12 1.8 6 .6 .20 6 6.1 .18 6 4.5 .10 6 1.6 .18 6 .2 .16 6 44 12 .6 6 Covance 6329-224 3M T-6314.2 159 Appendix 5 ANIMAL NUMBER Individual Clinical Chemistry Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL Group : 4 C94509 C94510 C94511 C94512 C94513 C94514 MEAN S.D. N Group : 5 C94515 C94516 C94517 C94518 C94519 C94520 MEAN S.D. N Group: 6 C94521 C94522 C94524 C94525 C94526 MEAN S.D. N Dose Level : 30 119 97 122 184 196 126 141 39.7 6 13 14 11 12 11 14 12 1.4 6 Dose Level : 100 167 16 80 15 80 13 90 18 119 16 161 15 116 39.8 6 16 1.6 6 Dose Level : 500 97 22 120 23 82 17 121 22 116 24 107 17.1 5 22 2 .,7 5 Dosage Unit: ppm MeFOS .4 .6 5.7 6.0 4.4 4.4 .6 6.0 4.4 .7 6.7 4.9 .5 6.0 4.4 .8 6.7 4.7 .6 6.2 4.5 .14 .42 .22 666 Dosage Unit: ppm MeFOS .6 5.8 4.5 .7 6.0 4.7 .6 6.1 4.8 .8 6.9 5.1 .5 5.9 4.4 .7 6.8 5.1 .6 6.2 4.8 .10 .48 .29 666 Dosage Unit: ppm MeFOS .6 6.0 5.2 .9 6.1 5.1 .7 6.2 5.0 .2 5.5 4.6 .7 6.4 5.6 .6 6.0 5.1 .26 .34 .36 555 1.3 1.6 1.6 1.8 1.6 2.0 1.6 .23 6 1.3 1.3 1.3 1.8 1.5 1.7 1.5 .22 6 .8 1.0 1.2 .9 .8 .9 .17 5 .0 .2 .4 .2 .0 .3 .2 .16 6 .0 ..10 .2 .1 .0 .1 .08 6 1.0 .4 .5 1..08 .7 .28 5 30 30 39 59 35 44 40 11.0 6 55 43 7 53 . 23 30 35 18.7 6 4 1 0 0 1 11.6 5 Covance 6329-224 3M T-6314.2 160 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Males Week: 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS AST/SGOT ALT/SGPT IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L Covance 6329-224 3M T-6314.2 PCOAO IU/G Group: i C94491 C94492 C94493 C94494 C94495 C94496 MEAN S.D. N Group: 2 C94497 C94498 C94499 C94500 C94501 C94502 MEAN S.D. ' N Group: 3 C94503 C94504 C94505 C94506 C94507 C94508 MEAN S.D. N Dose Level:; 0 97 29 91 37 97 37 90 34 1 0 2 34 1 0 1 36 96 5.0 6 34 3. 0 6 Dose Level;: 1 98 34 168 36 114 41 115 40 1 1 2 31 94 13 117 26.6 6 32 1 0 .3 6 Dose Level : 1 0 89 27 95 30 98 39 96 39 1 2 1 38 154 37 109 24.7 6 35 5.. 2 6 Dosage Unit: ppm MeFOS 0 11.1 1 2 .1 0 11.2 13.5 0 10.9 12.5 0 10.7 11.5 0 10.6 11.1 0 11.0 12.0 0 10.9 . 0 .23 66 1 2 .1 .84 6 Dosage Unit: ppm MeFOS 1 1 1 . 2 14.9 0 11.5 12.5 1 1 1 .1 10.8 0 11.1 11.6 0 11.0 10.7 0 11.0 12.3 0 .5 6 11.2 .19 6 1 2 .1 1.54 6 Dosage Unit: ppm MeFOS 0 11.6 12.4 0 11.5 10.9 0 1 2 . 0 15.5 0 10.9 1 1 . 2 0 11.0 10.7 0 11.0 10.4 0 11.3 . 0 .44 66 11.8 1.92 6 149 146 147 146 153 148 148 2 .6 6 7.2 9.4 6.4 6 .1 5.9 7.4 7.1 1.29 6 147 149 148 147 151 147 148 1 .. 6 6 9.7 6.8 6.2 6.6 6.0 9.8 7.5 1.75 6 145 148 145 148 153 147 148 2 ,.9 6 7.8 7.0 11.2 6.5 6.1 6.2 7.5 1.93 6 102 103 100 101 102 103 102 1 .2 6 100 101 101 100 103 103 101 1 .4 6 101 101 101 102 103 101 102 .8 6 10 6 9 11 8 10 9 1 .8 6 8 10 13 6 10 7 9 2 ..5 6 5 6 7 9 8 10 8 1 .9 6 161 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYD PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS AST/SGOT ALT/SGPT IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA K MMOL/L MMOL/L CL MMOL/L Covance 6329-224 3M T-6314.2 PCOAO IU/G Group : 4 C94509 C94510 C94511 C94512 C94513 C94514 MEAN S.D. N Group: 5 C94515 C94516 C94517 C94518 C94519 C94520 MEAN S.D. N Group: 6 C94521 C94522 C94524 C94525 C94526 MEAN S.D. N Dose Level:: 30 89 28 104 40 85 34 109 42 86 29 87 42 93 10.4 6 36 6 .,4 6 Dose Level:; 1 0 0 126 48 106 51 147 45 143 70 99 40 108 37 122 20.3 6 48 1 1 .7 6 Dose Level:: 500 1 0 0 92 316 569 164 240 125 138 1 2 2 73 165 87.3 5 222 204. 3 5 Dosage Unit: ppm MeFOS 0 10.7 1 1 . 6 0 10.7 11.7 1 11.3 11.6 0 11.8 9.9 1 11.5 11.0 0 11.2 9.9 0 .5 6 11.2 .44 6 11.0 .85 6 Dosage Unit: ppm MeFOS 0 10.2 10.3 0 10.3 1 1 . 0 0 11.2 12.8 0 11.0 11.5 0 10.5 10.9 0 11.8 11.3 0 10.8 . 0 .62 66 11.3 .84 6 Dosage Unit: ppm MeFOS 0 10.5 1 1 . 6 0 11.0 10.1 0 1 0 . 2 12.3 0 9.8 10.9 0 10.7 9.2 0 10.4 . 0 .46 55 10.8 1.22 5 148 150 149 148 148 149 149 .8 6 7.1 6.9 7.2 5.7 6.5 6.4 6.6 .56 6 147 149 147 147 147 149 148 1.0 6 6.4 7.4 8.5 7.7 7.4 6.1 7.2 .88 6 148 145 145 142 144 145 2.2 5 8.0 8.3 8.1 8.9 7.8 8.2 .42 5 104 104 104 101 100 101 102 1.9 6 101 104 102 100 101 97 101 2.3 6 104 100 101 100 102 101 1.7 5 5 9 7 5 9 11 8 2.4 6 7 5 7 6 7 7 6 .8 6 36 33 27 27 35 32 4.3 5 162 Appendix 5 ANIMAL NUMBER Individual Clinical Chemistry Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL Group: 1 Dose Level: 0 Dosage Unit: ppm MeFOS C94527 C94528 C94529 C94530 C94531 C94532 82 15 .5 5.9 4.5 1.4 . 0 38 1 1 2 15 . 8 7.1 5.5 1 . 6 . 0 57 1 1 0 13 .5 5.8 4.7 1 . 1 . 0 53 104 13 . 8 5.9 4.6 1.3 . 1 41 1 0 1 13 1 . 1 6 . 2 5.1 1 . 1 . 2 27 1 1 1 13 . 8 7.6 5.9 1.7 . 2 53 MEAN S.D. N 103 14 . 8 6.4 5.0 1.4 11.3 1 .0 .23 .75 .56 .25 6 666 6 6 .1 .10 6 45 1 1 .5 6 Group: 2 Dose Level: 1 Dosage Unit: ppm MeFOS C94533 C94534 C94535 C94536 C94537 C94538 128 14 .9 6 . 8 5.1 1.7 .1 55 88 14 .7 6.4 4.9 1.5 .4 73 104 18 .9 6.3 5.2 1 . 1 . 2 46 81 14 .4 5.9 4.9 1 . 0 . 2 43 131 16 .5 6.5 5.0 1.5 . 2 52 139 14 .4 6.9 5.6 1.3 .3 63 MEAN S.D. N 1 1 2 15 . 6 6.5 5.1 1.4 24.3 1 .,7 .23 .36 .26 .27 6 666 6 6 .2 .10 6 55 1 1 ., 1 6 Group: 3 Dose Level: 1 0 Dosage Unit: ppm MeFOS C94539 C94540 C94541 C94542 C94543 C94544 144 1 2 . 6 6.9 5.5 1.4 .1 47 90 1 2 .5 5.8 4.6 1 . 2 . 2 42 90 16 .7 6 . 2 4.9 1.3 .2 46 86 15 . 8 6.3 4.9 1.4 . 2 31 93 1 0 . 6 6.3 5.1 1 . 2 . 1 48 91 18 . 6 6 . 6 5.4 1 . 2 .3 64 MEAN S.D. N 99 14 . 6 6.4 5.1 1.3 22.2 3.0 .1 0 .37 .34 . 1 0 6 66 6 6 6 . 2 46 .08 1 0 ,.7 66 Covance 6329-224 3M T-6314.2 163 Appendix 5 ANIMAL NUMBER Individual Clinical Chemistry Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS GLU MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL Group: 4 C94545 C94546 C94547 C94548 C94549 C94550 MEAN S.D. N Group: 5 C94551 C94552 C94553 C94554 C94555 C94556 MEAN S.D. N Group: 6 C94557 C94558 C94559 C94560 C94561 C94562 MEAN S.D. N Dose Level : 30 137 1 1 1 2 2 13 158 19 83 1 2 125 16 160 20 131 28.4 6 15 3. 8 6 Dose Level: 100 1 0 1 16 158 29 147 14 107 14 76 15 81 15 112 33.9 6 17 5.8 6 Dose Level: 500 100 21 86 23 105 28 85 32 138 25 85 25 100 20.6 6 26 3.9 6 Dosage Unit: ppm MeFOS .5 5.8 4.5 .5 5.8 4.6 .9 6.5 5.2 .7 6 . 6 5.3 .4 5.8 4.7 1 . 0 7.8 6.3 .7 6.4 5.1 .24 .79 .67 6 66 Dosage Unit: ppra MeFOS .5 5.9 5.0 . 8 7.0 5.6 .5 6.9 5.8 .7 7.2 5.8 . 8 7.1 5.7 . 8 6.3 5.2 .7 6.7 5.5 .15 .52 .34 6 66 Dosage Unit: ppm MeFOS .4 6 . 8 5.8 . 6 7.3 6 . 1 . 8 6 . 1 5.4 .7 7.1 5.9 .4 7.3 6 . 2 . 8 7.3 6 . 1 . 6 7.0 5.9 .18 .48 .29 6 66 1.3 1.2 1.3 1.3 1 .1 1.5 1.3 .13 6 .9 1.4 1.1 1.4 1.4 1 .1 1.2 .21 6 1.0 1.2 .7 1.2 1 .1 1.2 1.1 .20 6 .0 .4 .1 .2 .1 .0 .1 .15 6 .3 .2 .2 .3 .2 .1 .2 .08 6 .5 .2 .5 1.0 .6 .3 .5 .28 6 55 69 54 39 52 54 54 9.5 6 19 39 46 64 40 19 38 17.1 6 1 2 6 8 10 17 7 5.9 6 Covance 6329-224 3M T-6314.2 164 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS AST/SGOT ALT/SGPT IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L Covance 6329-224 3M T-6314.2 PCOAO IU/G Group: 1 C94527 C94528 C94529 C94530 C94531 C94532 MEAN S.D. N Group : 2 C94533 C94534 C94535 C94536 C94537 C94538 MEAN S.D. N Group i 3 C94539 C94540 C94541 C94542 C94543 C94544 MEAN S.D. N Dose Level : 0 95 29 130 26 1 1 0 25 98 32 1 0 2 27 92 25 104 14.0 6 27 2 .7 6 Dose Leveli: 1 113 32 128 30 107 29 1 0 2 31 1 1 1 31 82 29 107 15.1 6 30 1.2 6 Dose Level : 1 0 113 26 128 19 1 0 2 28 109 33 102 21 197 34 125 36.5 6 27 6 ,. 1 6 Dosage Unit: ppm MeFOS 0 10.3 1 2 . 0 2 11.0 12.6 0 11.5 12.5 0 10.3 1 1 . 1 0 10.4 1 0 . 1 1 1 1 . 8 11.3 0 10.9 .8 .66 66 11.6 .95 6 Dosage Uni t: ppm MeFOS 0 11.3 14.6 1 11.3 11.7 2 11.3 12.9 0 10.7 10.7 0 12.1 13.9 0 11.7 1 0 . 8 0 11.4 . 8 .47 66 12.4 1.63 6 Dosage Unit: ppm MeFOS 0 11.6 11.2 0 10.1 10.2 0 11.7 13.4 0 11.0 13.1 0 10.8 11.7 0 11.3 11.7 0 11.1 . 0 .59 66 11.9 1.20 6 147 148 146 146 148 147 147 9 6 9.2 8.2 9.2 7.6 5.6 7.5 7.9 1.34 6 145 151 146 148 144 148 147 2 .5 6 10.6 7.2 9.1 6.2 9.6 6.8 8.2 1.76 6 146 144 146 145 148 147 146 1,.4 6 8.2 9.9 8.7 10.0 8 .1 8.7 8.9 .83 6 106 101 104 103 102 102 103 1.8 6 102 105 104 104 103 103 104 1.0 6 101 103 104 102 105 103 103 1.4 6 7 5 5 3 7 4 5 1.6 6 5 6 5 9 7 4 6 1.8 6 7 5 6 9 7 6 7 1.4 6 165 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS AST/SGOT ALT/SGPT IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L Covance 6329-224 3M T-6314.2 PCOAO IU/G Group: 4 C94545 C94546 C94547 C94548 C94549 C94550 MEAN S.D. N Group: 5 C94551 C94552 C94553 C94554 C94555 C94556 MEAN S.D. N Group: 6 C94557 C94558 C94559 C94560 C94561 C94562 MEAN S.D. N Dose Level: 30 105 29 94 30 81 25 142 41 91 23 88 20 100 2 2 .,0 6 28 7.4 6 Dose Level: 100 1 0 1 33 91 28 76 2 0 82 31 94 32 94 31 90 9.1 6 29 4.8 6 Dose Level: 500 95 57 128 49 145 67 117 54 130 89 90 43 118 21.4 6 60 16.4 6 Dosage Unit: ppm MeFOS 1 10.9 10.2 0 11.2 11.3 4 11.1 10.0 0 10.5 9.9 1 10.6 11.8 0 12.2 9.8 1 11.1 1.5 .61 66 10.5 .84 6 Dosage Unit: ppm MeFOS 0 11.0 12.8 0 11.5 1 1 . 1 0 12.4 10.4 0 11.1 10.6 0 11.6 12.5 0 11.0 11.6 0 11.4 . 0 .54 66 11.5 .99 6 Dosage Unit: ppm MeFOS 0 11.2 10.9 0 10.5 10.3 0 10.4 10.4 0 11.1 11.6 0 11.7 10.9 0 10.6 9.7 0 10.9 . 0 .50 66 10.6 .65 6 147 145 145 151 143 147 146 2.7 6 6.8 7.9 6.0 5.8 8.5 7.3 7.0 1.06 6 146 146 146 146 149 148 147 1.3 6 8.4 7.8 7.1 7.7 7.7 7.1 7.6 .49 6 147 149 148 147 146 151 148 1.8 6 6.5 6.4 7.6 7.4 7.5 5.7 6.8 .77 6 104 101 102 103 102 102 102 1.0 6 102 103 102 104 102 104 103 1.0 6 102 99 107 99 101 103 102 3.0 6 7 3 11 7 4 5 6 2 6 11 3 9 7 9 11 8 3.0 6 46 22 20 26 45 22 30 12.0 6 166 Appendix 5 Individual Clinical Urinalysis Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U VOL ML SP GR U PH Group: 1 C94491 C94492 C94493 C94494 C94495 C94496 MEAN S.D. N Group: 2 C94497 C94498 C94499 C94500 C94501 C94502 MEAN S.D. N Group: 3 C94503 C94504 C94505 C94506 C94507 C94508 MEAN S.D. N Dose Level: 0 5.7 31.5 26.9 19.0 9.4 18.5 1.032 1.0 10 1.0 10 1.015 1.026 1.0 10 18.5 9.86 6 1.017 .0096 6 Dose Level:: 1 10.2 48.9 a 4.4 7.4 47.0 a 48.3 a 1.020 1.005 1.029 1.026 1.004 1.007 27.7 22.39 6 1.015 .0112 6 Dose Level : 1 0 35.0 14.3 44.9 14.7 41.7 19.8 1.0 10 1.013 1.008 1 .0 12 1.006 1 .0 12 28.4 13.81 6 1 .0 10 .0027 6 Dosage Unit: ppm MeFOS 7.0 7.5 7.5 7.5 7.5 7.5 7.4 .20 6 Dosage Unit: ppm MeFOS 7.0 7.0 7.5 7.0 7.5 7.5 7.2 .27 6 Dosage Unit: ppm MeFOS 7.0 7.0 7.0 7.5 7.0 7.5 7.2 .26 6 a Sample was overflowing at the time of collection. 167 Covance 6329-224 3M T-6314.2 Appendix 5 Individual Clinical Urinalysis Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U VOL ML SP GR U PH Group: 4 C94509 C94510 C94511 C94512 C94513 C94514 MEAN S.D. N Group: 5 C94515 C94516 C94517 C94518 C94519 C94520 MEAN S.D. N Group: 6 C94521 C94522 C94524 C94525 C94526 MEAN S.D. N Dose Level:: 30 37.0 22.8 9.5 26.0 48.5 a 12.4 1.005 1 .0 12 1.023 1.0 12 1.008 1.020 26.0 14.80 6 1.013 .0069 6 Dose Level: 1 0 0 7.5 7.3 3.0 10.6 17.3 49.8 a 1.034 1.028 1.030 1.025 1.016 1.005 15.9 17.26 6 1.023 .0107 6 Dose Level: 500 17.5 43.9 a 26.4 4.6 9.6 1.014 1.007 1.0 10 1.038 1.024 20.4 15.52 5 1.019 .0126 5 Dosage Unit: ppm MeFOS 6.5 7.0 7.0 7.0 7.0 7.0 6.9 .20 6 Dosage Unit: ppm MeFOS 6.5 6.5 8.0 7.0 6.5 7.0 6.9 .58 6 Dosage Unit: ppm MeFOS 7.0 7.0 7.0 6.5 6.5 6.8 .27 5 a Sample was overflowing at the time of collection. 168 Covance 6329-224 3M T-6314.2 Appendix 5 Individual Clinical Urinalysis Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U PRO MG/DL U GLU U KET U BILI U BLOOD UROBILI Group: 1 C94491 C94492 C94493 C94494 C94495 C94496 Group: 2 C94497 C94498 C94499 C94500 C94501 C94502 Group: 3 C94503 C94504 C94505 C94506 C94507 C94508 Group: 4 C94509 C94510 C94511 C94512 C94513 C94514 Dose Level: 0 30 _ 30 - 10 - 10 - 30 30 - Dose Level: 1 30 _ 10 - 100 - 30 - 0- 10 - Dose Level: 10 10 _ 30 - 10 - 30 - 10 - 10 Dose Level: 30 0_ 10 - 30 - 10 - 10 - 30 - Dosage Unit: ppm MeFOS ++ _ -- -- ++ ++ +- _ - Dosage Unit: ppm MeFOS +_ -- _ - +- - -- - + - - Dosage Unit: ppm MeFOS __ + -- - --- -- - -- Dosage Unit: ppm MeFOS __ +++ - _- - -- - --- _ _ " _ _ - " _ - - _ _ _ - 169 Covance 6329-224 3M T-6314.2 Appendix 5 Individual Clinical Urinalysis Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U PRO MG/DL U GLU u KET U BILI U BLOOD UROBILI Group: 5 C94515 C94516 C94517 C94518 C94519 C94520 Group: 6 C94521 C94522 C94524 C94525 C94526 Dose Level : 100 30 _ 30 100 10 - 10 - 0 Dose Level: 500 10 _ 010 30 10 " Dosage Unit: ppm MeFOS ++ ++ +++ ++ +++ + + ++ Dosage Unit: ppm MeFOS +_ ++++ ++++ _ - - - - - Covance 6329-224 3M T-6314.2 Appendix 5 ANIMAL NUMBER Individual Clinical Urinalysis Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC WBC EPITH BACT CASTS CRYSTALS PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 URINE APPI COMMENTS Group: 1 C94491 C94492 C94493 C94494 C94495 C94496 Group : 2 C94497 C94498 C94499 C94500 C94501 C94502 Group: 3 C94503 C94504 C94505 C94506 C94507 C94508 Group: 4 C94509 C94510 C94511 C94512 C94513 C94514 Dose Level: 0 10 00 00 00 00 00 Dose Level : 1 00 00 00 04 00 00 Dose Level : 1 0 00 00 00 00 00 10 Dose Level: 30 00 00 00 00 00 00 Dosage Unit: ppm MeFOS 020 1 20 1 10 1 10 1 20 1 10 Dosage Unit: ppm MeFOS 1 20 1 30 1 10 1 20 110 1 20 Dosage Unit: ppm MeFOS 1 10 1 10 1 20 1 20 1 20 1 10 Dosage Unit: ppm MeFOS 010 1 10 110 1 10 1 30 01 0 4D 4D 4D 4D 4D 4D 4D 3B1D 4D 4D 4D 4D 3D 0 0 4D 0 3D 0 4D 4D ID 3D 4D CJ BJ BJ BJ BJ AJ BJ AJ CJ BK AJ BJ AJ BJ BJ BJ AJ BJ AJ BJ BJ BJ BJ BJ P Q P PQ PQ Q PQ Q PQ Q Q Q Q Q Q Q PQ Q Q PQ Q Q Q Covance 6329-224 3M T-6314.2 171 Appendix 5 ANIMAL NUMBER Individual Clinical Urinalysis Data Males Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC WBC EPITH BACT CASTS CRYSTALS PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 URINE APP1 COMMENTS Group : 5 C94515 C94516 C94517 C94518 C94519 C94520 Group: 6 C94521 C94522 C94524 C94525 C94526 Dose Level: 1 0 0 30 00 00 00 00 00 Dose Level: 500 00 00 00 00 01 Dosage Unit: ppm MeFOS 110 1 20 0 30 1 20 110 110 Dosage Unit: ppm MeFOS 01 0 01 0 01 0 1 20 1 10 4D 3D 2B4D 4D 3D 0 2D 0 4D ID 4D CJ BJ FL BJ BJ AJ BJ AJ BJ CJ BJ PQ PQ Q PQ PQ Q Q - Q PQ Covance 6329-224 3M T-6314.2 Appendix 5 Individual Clinical Urinalysis Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U VOL ML SP GR U PH Group : 1 Dose Level: 0 Dosage Unit: ppm MeFOS C94527 C94528 C94529 C94530 C94531 C94532 14.5 7.1 49.0 a 48.0 15.0 50.0 a 1.015 1.022 1.004 1.005 1 .0 10 1.002 7.5 6.5 7.0 7.0 7.5 7.0 MEAN S.D. N 30.6 20.36 6 1.0 10 .0077 6 7.1 .38 6 Group: 2 Dose Level;: 1 Dosage Unit: ppm MeFOS C94533 C94534 C94535 C94536 C94537 C94538 11.6 17.1 15.0 14.0 46.6 a 50.0 a 1.013 1.005 1 .0 10 1.013 1.004 1.004 7.5 6.5 7.0 7.0 7.0 7.0 MEAN S.D. N 25.7 17.62 6 1.008 .0044 6 7.0 .32 6 Group : 3 Dose Level : 1 0 Dosage Unit: ppm MeFOS C94539 C94540 C94541 C94542 C94543 C94544 46.8 a 47.0 a 28.2 9.9 16.8 14.0 1.002 1.003 1 .0 10 1.018 1.002 1 .0 10 6.5 7.0 7.0 7.0 7.0 7.0 MEAN S.D. N 27.1 16.49 6 1.008 .0064 6 6.9 .20 6 a Sample was overflowing at the time of collection. 173 Covance 6329-224 3M T-6314.2 Appendix 5 Individual Clinical Urinalysis Data Females Week S 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U VOL ML SP GR U PH Group: 4 Dose Level:: 30 Dosage Unit: ppm MeFOS C94545 C94546 C94547 C94548 C94549 C94550 16.5 5.4 3.4 28.0 14.8 21.6 1.0 10 1.028 1.026 1.008 1.0 10 1.006 7.5 6.5 7.0 7.0 7.5 7.0 MEAN S.D. N 15.0 9.40 6 1.015 .0097 6 7.1 .38 6 Group: 5 Dose Level:; 1 0 0 Dosage Unit: ppm MeFOS C94551 C94552 C94553 C94554 C94555 C94556 24.0 10.7 30.0 49.0 a 50.0 a 10.3 1.007 1.0 10 1.008 1.003 1.003 1.018 7.5 7.0 7.0 7.0 7.0 6.5 MEAN S.D. N 29.0 17.62 6 1.008 .0056 6 7.0 .32 6 Group: 6 Dose Level:: 500 Dosage Unit: ppm MeFOS C94557 C94558 C94559 C94560 C94561 C94562 15.0 9.6 11.6 4.0 40.2 8.2 1 .0 10 1.016 1.013 1.006 1.005 1.015 7.0 7.0 6.5 7.5 7.0 7.0 MEAN S.D. N 14.8 12.98 6 1.0 11 .0046 6 7.0 .32 6 a Sample was overflowing at the time of collection. 174 Covance 6329-224 3M T-6314.2 Appendix 5 Individual Clinical Urinalysis Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U PRO MG/DL U GLU u KET U BILI U BLOOD UROBILI Group: 1 C94527 C94528 C94529 C94530 C94531 C94532 Group: 2 C94533 C94534 C94535 C94536 C94537 C94538 Group: 3 C94539 C94540 C94541 C94542 C94543 C94544 Group: 4 C94545 C94546 C94547 C94548 C94549 C94550 Dose Level: 0 10 10 0010 0 Dose Level: 1 0_ 010 - 00- 0 Dose Level: 10 0- 0010 - 00 Dose Level: 30 10 _ 10 10 010 0- Dosage Unit: ppm MeFOS __ -- - -- - -- - -- - -- - Dosage Unit: ppm MeFOS _ -- - -- - -- - -- - -" Dosage Unit: ppm MeFOS __ -- -- -- - - - - - Dosage Unit: ppm MeFOS -_ ------ _ - _ - - - - _ - - - _ - 175 Covance 6329-224 3M T-6314.2 Appendix 5 Individual Clinical Urinalysis Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U PRO MG/DL U GLU U KET U BILI U BLOOD UROBILI Group: 5 Dose Level: 100 C94551 C94552 C94553 C94554 C94555 C94556 0 0 0 0 0 0 Group: 6 Dose Level: 500 C94557 C94558 C94559 C94560 C94561 C94562 0 10 0 0 0 0 Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Covance 6329-224 3M T-6314.2 176 ANIMAL NUMBER Appendix 5 Individual Clinical Urinalysis Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC WBC EPITH BACT CASTS CRYSTALS PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 URINE APPl COMMENTS Group: 1 C94527 C94528 C94529 C94530 C94531 C94532 Group: 2 C94533 C94534 C94535 C94536 C94537 C94538 Group: 3 C94539 C94540 C94541 C94542 C94543 C94544 Group: 4 C94545 C94546 C94547 C94548 C94549 C94550 Dose Level: 0 00 00 00 00 01 00 Dose Level: 1 00 00 00 00 04 00 Dose Level: 1 0 00 00 00 00 00 00 Dose Level: 30 14 00 00 00 00 01 Dosage Unit: ppm MeFOS i2 0 i1 0 i1 0 i1 0 i1 0 i2 0 Dosage Unit: ppm MeFOS 01 0 020 1 20 1 10 1 10 01 0 Dosage Unit: ppm MeFOS 020 1 10 010 1 10 010 010 Dosage Unit: ppm MeFOS 1 20 110 1 10 1 10 1 10 010 4D ID 0 40 3D 4B 4D 0 0 4D 0 3D 2B 0 0 4D ID 0 2B4D 0 4D 4D 4D 0 BJ BJ AJ AJ BJ AJ BJ AJ BJ BJ AJ AJ AJ AJ AJ BJ BJ BJ BJ CJ BJ BJ CJ AJ _ - _ p - P - - _ - - _ - Covance 6329-224 3M T-6314.2 177 Appendix 5 ANIMAL NUMBER Individual Clinical Urinalysis Data Females Week 5 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC WBC EPITH BACT CASTS CRYSTALS PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 URINE APP1 COMMENTS Group: 5 C94551 C94552 C94553 C94554 C94555 C94556 Dose Level : 1 0 0 00 00 00 00 00 01 Dosage Unit: ppm MeFOS 110 110 110 01 0 110 110 0 0 0 0 0 0 AJ _ AJ AJ - AJ AJ _ BJ P Group : 6 Dose Level: 500 ' Dosage Unit: ppm MeFOS C94557 0 0 1 2 0 0 BJ _ C94558 0 0 1 2 0 0 BJ - C94559 0 0 1 1 0 0 BJ - C94560 0 0 1 1 0 0 AJ - C94561 0 0 0 1 0 ID AJ - C94562 0 0 0 1 0 3D BJ - Covance 6329-224 3M T-6314.2 178 APPENDIX 6 Individual Absolute Organ Weight Data (g) Individual Organ-to-Body Weight Percentages Individual Organ-to-Brain Weight Ratios Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 179 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 1 TABLE INCLUDES: SEX=ALL;GROUF=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN EP - EPIDIDYMIDES DEATH=T;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS TH - THYMUS SEX DOSE ANIMAL TERMINAL -- _ _ _ _ _ -- _ _ _ _ _ __ _ _ . GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP TE M 1 C94491 M 1 C94492 M 1 C94493 M 1 C94494 M 1 C94495 M 1 . C94496 335.4 361.6 339.1 379.4 343.5 291.7 0.0612 0.0515 0.0563 0.0634 0.0416 0.0725 2.1109 1.9843 1.9218 2.1238 2.1985 2.0137 1.0347 0.8785 0.8731 1.0167 0.8446 0.8805 3.6123 3.2546 3.6572 3.7571 3.2033 2.9056 14.0407 13.6908 12.4081 14.3488 13.3219 9.6607 0.9276 0.7517 0.7500 0.7848 0.8125 0.8029 3.4698 2.9808 2.8478 3.2911 2.9317 2.8137 NUMBER IN GROUP MEAN: STANDARD DEV: 341.8 29.6 0.0577 0.0106 2.0588 0.1028 0.9214 0.0821 3.3984 0.3295 12.9118 1.7284 0.8049 0.0654 3.0558 0.2644 M 2 C94497 M 2 C94498 M 2 C94499 M 2 C94500 M 2 C94501 M 2 C94502 345.7 321.0 384.3 320.2 332.4 323.8 0.0579 0.0630 0.0454 0.0575 0.0621 0.0565 1.8832 2.0462 2.0893 2.1243 2.0688 1.9994 0.8967 0.9478 0.8275 0.8480 0.9718 0.8940 2.5682 2.8116 3.4950 3.5756 3.0639 3.1062 11.7523 11.9965 14.2738 11.9975 11.6636 13.0440 0.7741 0.5888 0.8183 0.7821 0.8350 0.7124 2.8943 2.7400 3.0946 2.7896 2.9111 3.2586 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 337.9 24.7 6 0.0571 0.0063 6 2.0352 0.0854 6 0.8976 0.0555 6 3.1034 0.3872 6 12.4546 1.0193 6 0.7518 0.0904 6 2.9480 0.1952 M 3 C94503 M 3 C94504 M 3 C94505 338.4 369.1 337.9 0.0719 0.0644 0.0562 1.8517 2.0698 2.1689 1.0084 0.8887 1.0062 3.4730 3.7053 3.3038 12.6442 13.2875 13.4179 0.9372 0.7590 0.6947 3.3072 2.8135 3.1618 ** CONTINUED ON NEXT PAGE ** 0.5026 0.5711 0.4336 0.6600 0.9318 0.5241 0.6039 0.1774 0.5496 0.6983 0.9560 0.8007 0.5562 0.5391 6 0.6833 0.1692 0.7104 0.8812 0.6890 180 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL : AD -ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP TE TH M 3 C94506 M 3 C94507 M 3 C94508 322.1 298.0 357.8 0.0479 0.0676 0.0567 1.8990 2.0294 2.0861 0.9847 0.8627 1.1055 3.3090 2.9125 3.3758 12.2100 11.2672 13.4521 0.7515 0.6989 0.8250 2.6611 3.2209 2.8780 0.5349 0.5221 0.7962 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 337.2 25.3 6 0.0608 0.0088 6 2.0175 0.1200 6 0.9760 0.0886 6 3.3466 0.2597 6 12.7132 0.8627 6 0.7777 0.0914 6 3.0071 0.2583 6 0.6890 0.1418 M 4 C94509 M 4 C94510 M 4 C94511 M 4 C94512 M 4 C94513 M 4 C94514 301.9 282.3 308.5 365.6 330.7 349.8 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 323.1 31.3 M 5 C94515 M 5 C94516 M 5 C94517 M 5 C94518 331.8 295.2 337.9 316.7 ** CONTINUED ON NEXT PAGE ** 0.0566 0.0478 0.0530 0.0377 0.0538 0.0630 6 0.0520 0.0086 0.0545 0.0456 0.0725 0.0549 2.1850 2.0063 2.0354 1.9763 2.2273 2.3348 6 2.1275 0.1430 2.1887 2.0552 1.9646 2.0189 0.9372 0.7471 0.8228 0.9490 0.8336 0.9083 6 0.8663 0.0785 0.8303 0.7772 1.1014 0.7763 3.0753 2.9461 2.9192 3.1823 3.5906 3.6837 6 3.2329 0.3284 3.4080 3.1619 3.6453 3.1469 10.1043 10.3504 12.4616 13.9926 13.3383 13.7000 6 12.3245 1.7057 17.4565 16.0421 15.5417 19.5437 0.5576 0.7116 0.6977 0.7251 0.6600 0.8910 6 0.7072 0.1085 0.6778 0.7592 0.6331 0.7817 3.0521 2.6666 2.6572 3.1206 2.9338 3.1234 6 2.9256 0.2156 3.0282 3.0667 3.1028 2.7821 0.6354 0.4856 0.5913 0.5207 0.5986 0.6808 6 0.5854 0.0721 0.7223 0.7229 0.5009 0.7942 181 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 3 TABLE INCLUDES: SEX=ALL ;GROUP=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN EP - EPIDIDYMIDES DEATH=T ;SUBSET= ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP TE TH M 5 C94519 M 5 C94520 317.4 325.4 0.0522 0.0485 2.1524 2.1764 0.7815 0.8017 3.0339 3.3572 14.5708 17.1128 0.7127 0.4740 2.8462 3.0040 0.5508 0.6690 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 320.7 15.0 6 0.0547 0.0094 6 2.0927 0.0928 6 0.8447 0.1274 6 3.2922 0.2223 6 16.7113 1.7399 6 0.6731 0.1114 6 2.9717 0.1282 6 0.6600 0.1124 M 6 C94521 M 6 C94522 M 6 C94524 M 6 C94525 M 6 C94526 226.3 243.9 2 11.8 228.0 229.1 0.0436 0.0735 0.0573 0.0507 0.0596 1.8883 1.9366 1.9767 2.1492 2.0535 0.6830 0.7866 0.6364 0.7775 0.7748 2.3557 2.8945 2.4286 2.5308 2.7529 20.2477 19.4615 18.0054 19.5937 20.7386 0.6046 0.5137 0.6151 0.6822 0.4943 3.1040 3.2106 2.4897 3.1146 3.0650 0.6047 0.4000 0.3243 0.4146 0.5015 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 227.8 11.4 5 0.0569 0.0112 5 2.0009 0.1027 5 0.7317 0.0679 5 2.5925 0.2256 5 19.6094 1.0341 5 0.5820 0.0775 5 2.9968 0.2885 5 0.4490 0.1074 182 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESOLFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT M1 M1 M1 M1 M1 M1 C94491 C94492 C94493 C94494 C94495 C94496 335.4 361.6 339.1 379.4 343.5 291.7 0.0223 0.0177 0.0177 0.0299 0.0189 0.0172 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 341.8 29.6 6 0.0206 0.0049 M 2 C94497 M 2 C94498 M 2 C94499 M 2 C94500 M 2 C94501 M 2 C94502 345.7 321.0 384.3 320.2 332.4 323.8 0.0295 0.0252 0.0216 0.0213 0.0155 0.0273 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 337.9 24.7 6 0.0234 0.0050 M 3 C94503 M 3 C94504 M 3 C94505 338.4 369.1 337.9 0.0198 0.0231 0.0230 ** CONTINUED ON NEXT PAGE ** 183 Covance 6329-224 3M T-6314.2 PAGE: 4  APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT M 3 C94506 M 3 C94507 M 3 C94508 322.1 298.0 357.8 0.0189 0.0224 0.0282 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 337.2 25.3 6 0.0226 0.0033 M 4 C94509 M 4 C94510 M 4 C94511 M 4 C94512 M 4 C94513 M 4 C94514 301.9 282.3 308.5 365.6 330.7 349.8 0.0160 0.0192 0 .0 111 0.0254 0.0216 0.0304 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 323.1 31.3 6 0.0206 0.0068 M 5 C94515 M 5 C94516 M 5 C94517 M 5 C94518 331.8 295.2 337.9 316.7 0.0252 0.0201 0.0207 0.0203 ** CONTINUED ON NEXT PAGE ** Covance 6329-224 3M T-6314.2 PAGE: 5 184 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T; SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT M 5 C94519 M 5 C94520 317.4 325.4 0.0172 0.0278 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 320.7 15.0 6 0.0219 0.0039 M 6 C94521 M 6 C94522 M 6 C94524 M 6 C94525 M 6 C94526 226.3 243.9 2 1 1 .B 228.0 229.1 0.0149 0.0172 0.0191 0.0303 0.0172 NUMBER IN GROUP : MEAN: STANDARD DEV: 5 227.8 11.4 5 0.0197 0.0061 Covance 6329-224 3M T-6314.2 PAGE: 6 185 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T; SUBSET=ALL : AD - ADRENAL, BR - BRAIN, E P - E PID ID Y M ID ES : KD - KIDNEY, L I - L IV E R , OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - T E S T IS , TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP F 1 C94527 F 1 C94528 F 1 C94529 F 1 C94530 F 1 C94531 F 1 C94532 213.0 210.0 228.8 235.2 207.8 184.7 0.0715 0.0706 0.1022 0.0605 0.0655 0.0682 2.0013 1.9160 1.9228 2.0288 1.9550 1.9062 2.0130 1.9295 2.6260 2.1802 2.0538 1.7582 7.4326 7.8862 8.7876 8.2680 7.5010 6.6326 0.1162 0.0945 0.1418 0.1644 0.1314 0.1150 0.5561 0.3804 0.6896 0.5085 0.4679 0.4453 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 213.3 17.8 6 0.0731 0.0148 6 1.9550 0.0500 6 2.0935 0.2961 6 7.7513 0.7450 6 0.1272 0.0243 6 0.5080 0.1069 F 2 C94533 200.3 F 2 C94534 197.5 F 2 C94535 217.3 F 2 C94536 204.4 F 2 C94537 223.4 F 2 C94538 - 192.6 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 205.9 1 2 .0 F 3 C94539 F 3 C94540 F 3 C94541 217.8 174.2 234.2 ** CONTINUED ON NEXT PAGE ** 0.0639 0.0655 0.0683 0.0803 0.0733 0.0606 6 0.0687 0.0071 0.1090 0.0624 0.0850 2.0393 2.0617 2.0698 1.8203 2.0384 1.8703 6 1.9833 0.1088 2.0113 1.9367 2.0657 1.9056 1.9166 1.8145 2.0013 2.2858 1.8873 6 1.9685 0.1666 2.6878 1.9136 2.5187 8.3329 7.1556 7.8013 6.8621 8.2008 6.9707 6 7.5539 0.6425 8.3813 6.6088 8.8330 0.1402 0.1380 0.1276 0.1446 0.1269 0.1094 6 0.1311 0.0128 0.1454 0.1402 0.1394 0.5051 0.4487 0.5174 0.6338 0.4833 0.4307 6 0.5032 0.0719 0.5526 0.3929 0.6589 Covance 6329-224 3M T-6314.2 PAGE: 7 TE TH 0.4566 0.6013 0.6188 0.5445 0.5398 0.5121 6 0.5455 0.0592 0.4569 0.3874 0.4819 0.5764 0.5223 0.7123 6 0.5229 0.1124 0.4936 0.3952 0.6495 186 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T ;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP F 3 C94542 F 3 C94543 F 3 C94544 242.5 167.9 185.5 0.0880 0.0487 0.0563 2.0048 1.8660 2.0395 2.5368 1.7414 2.1156 9.4944 6.4505 8.2267 0.1565 0.0986 0.1453 0.5490 0.3354 0.4673 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 203.7 32.0 6 0.0749 0.0229 6 1.9873 0.0735 6 2.2523 0.3837 6 7.9991 1.2215 6 0.1376 0.0200 6 0.4927 0.1181 F4 F4 F4 F4 F4 F' 4 C94545 C94546 C94547 C94548 C94549 C94550 187.2 219.7 237.1 186.8 207.7 187.0 0.0585 0.0634 0.0794 0.0536 0.0653 0.0630 1.8832 2.0493 2.1499 2.0980 2.0569 1.9038 2.0151 2.1332 2.2587 1.9018 2.1431 1.8946 7.1725 9.5768 9.8392 6.8828 8.7554 7.7017 0.1228 0.1006 0.1338 0.0940 0.1636 0.0960 0.4640 0.5830 0.5588 0.4053 0.5145 0.4316 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 204.3 2 1 .1 6 0.0639 0.0087 6 2.0235 0.1071 6 2.0578 0.1457 6 8.3214 1.2523 6 0.1185 0.0273 6 0.4929 0.0710 F 5 C94551 F 5 C94552 F 5 C94553 F 5 C94554 171.1 201.4 206.3 184.4 0.0661 0.0660 0.0679 0.0582 1.8855 2.0531 2.0290 1.8946 1.9419 2.3079 2.2091 1.9402 8.7911 10.2382 10.4906 8.6778 0.1289 0.1255 0.1087 0.0972 0.4517 0.4772 0.4567 0.3575 ** CONTINUED ON NEXT PAGE ** Covance 6329-224 3M T-6314.2 PAGE: 8 TE TH 0.6078 0.5563 0.4899 6 0.5321 0.0918 0.4712 0.6427 0.5987 0.6280 0.4439 0.5060 6 0.5484 0.0854 0.3160 0.3988 0.6089 0.3711 187 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP F 5 C94555 F 5 C94556 192.5 206.1 0.0605 0.0777 2.0725 2.0897 2.1591 2.6036 10.0252 9.4436 0.1028 0.1349 0.4944 0.6082 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 193.6 13.9 6 0.0661 0.0068 6 2.0041 0.0906 6 2.1936 0.2491 6 9.6111 0.7628 6 0.1163 0.0155 6 0.4743 0.0810 F 6 C94557 F 6 C94558 F 6 C94559 F 6 C94560 F 6 C94561 F 6 C94562 151.5 154.4 134.5 172.6 161.3 165.1 0.0381 0.0453 0.0351 0.0389 0.0618 0.0589 1.9430 2 .1 1 0 1 1.7981 2.0925 1.9670 2.0415 1.6979 1.7106 1.4107 1.6771 1.9650 1.8903 12.4887 12.6860 9.8766 14.9295 13.3315 10.9656 0.0758 0.0777 0.0511 0.0671 0.0797 0.1065 0.3143 0.4358 0.4295 0.5289 0.4122 0.4382 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 156.6 13.2 6 0.0464 0.0114 6 1.9920 0.1159 6 1.7253 0.1934 6 12.3797 1.7764 6 0.0763 0.0181 6 0.4265 0.0686 Covance 6329-224 3M T-6314.2 PAGE: 9 TE TH 0.8204 0.5221 6 0.5062 0.1873 0.3376 0.4256 0.4142 0.6468 0.4100 0.5178 6 0.4587 0.1086 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL - - - - GROUP NUMBER BODY WT ( g ) TT F 1 C94527 F 1 C94528 F 1 C94529 F 1 C94530 F 1 C94531 F 1 C94532 213.0 210.0 228.8 235.2 207.8 184.7 0.0155 0.0141 0.0177 0.0133 0.0173 0.0175 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 213.3 17.8 6 0.0159 0.0019 F 2 C94533 F 2 C94534 F 2 C94535 F 2 C94536 F 2 C94537 F 2 C94538 NUMBER IN GROUP : MEAN: STANDARD DEV: 200.3 197.5 217.3 204.4 223.4 192.6 6 205.9 12.0 0.0197 0.0217 0.0196 0.0140 0.0192 0.0143 6 0.0181 0.0032 F 3 C94539 F 3 C94540 F 3 C94541 217.8 174.2 234.2 ** CONTINUED ON NEXT PAGE ** 0.0066EX 0.0217 0.0164 189 Covance 6329-224 3M T-6314.2 PAGE: 10 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL - - - GROUP NUMBER BODY WT ( g ) TT F 3 C94542 F 3 C94543 F 3 C94544 242.5 167.9 185.5 0.0250 0.0192 0.0140 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 203.7 32.0 5 0.0193 0.0043 F 4 C94545 F 4 C94546 F 4 C94547 F 4 C94548 F 4 C94549 F 4 C94550 NUMBER IN GROUP : MEAN: STANDARD DEV: 187.2 219.7 237.1 186.8 207.7 187.0 6 204.3 2 1 .1 0.0131 0.0293 0.0129 0.0167 0.0221 0.0165 6 0.0184 0.0063 F 5 C94551 F 5 C94552 F 5 C94553 F 5 C94554 171.1 201.4 206.3 184.4 ** CONTINUED ON NEXT PAGE ** 0.0126 0.0244 0.0237 0.0149 190 Covanee 6329-224 3M T-6314.2 PAGE: 11 APPENDIX 6 Individual Absolute Organ Weight Data (g) Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP-ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT F 5 C94555 F 5 C94556 192.5 206.1 0.0177 0.0150 NUMBER IN GROUP : MEAN; STANDARD DEV: 6 193.6 13.9 6 0.0181 0.0049 F 6 C94557 F 6 C94558 F 6 C94559 F 6 C94560 F 6 C94561 F 6 C94562 NUMBER IN GROUP: MEAN: STANDARD DEV: 151.5 154.4 134.5 172.6 161.3 165.1 6 156.6 13.2 0.0152 0.0122 0.0118 0.0095 0.0182 0.0154 6 0.0137 0.0031 Covance 6329-224 3M T-6314.2 PAGE: 12 191 APPENDIX 6 Covance 6329-224 3M T-6314.2 Individual Organ-to-Body Weight Percentages I Terminal Sacrifice 4 -WEEK RANGE-FINDING DIETARY TOXIC IT Y STUDY WITH N-METHYIi PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T - 6 3 1 4 ) I N RATS PAGE: 1 TABLE INCLUDES: SEX=ALL; GROUP=ALL; WEEKS=ALL DEATH=T;SUBSET=ALL : AD - ADRENAL, BR - BRAIN, E P - EPIDID YMID ES : KD - KIDNEY, L I - L IV E R , OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - T E S T I S , TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT ( g ) AD BR EP KD LI OV SP M1 M1 M1 M1 M1 M1 C94491 C94492 C94493 C94494 C94495 C94496 335.4 361.6 339.1 379.4 343.5 291.7 0.0182 0.0142 0.0166 0.0167 0.0121 0.0249 0.6294 0.5488 0.5667 0 .5 5 9 8 0.6400 0.6903 0.3085 0.2429 0.2575 0.2680 0.2459 0.3019 1.0770 0.9001 1.0785 0.9903 0.9325 0.9961 4.1863 3.7862 3.6591 3.7820 3 .8 7 8 3 3.3119 0 .2 7 6 6 0.2079 0.2212 0.2069 0.2365 0.2752 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 341.8 2 9 .6 6 0.0171 0.0044 6 0.6058 0.0562 6 0.2708 0.0282 6 0.9957 0.0730 6 3.7673 0 .2 8 5 5 6 0.2374 0.0317 M2 M2 M2 M2 M2 M2 C94497 C94498 C94499 C94500 C94501 C94502 NUMBER IN GROUP: MEAN: STANDARD DEV: 345.7 321.0 384.3 320.2 332.4 ' 323.8 6 337.9 24.7 0.0167 0.0196 0.0118 0.0180 0.0187 0.0174 6 0.0170 0.0027 0.5447 0.6374 0.5437 0.6634 0.6224 0.6175 6 0.6049 0.0496 0.2594 0.2953 0.2153 0.2648 0.2924 0.2761 6 0.2672 0.0292 0.7429 0.8759 0.9094 1 .1 1 6 7 0.9218 0.9593 6 0.9210 0 .1 2 1 4 3 .3 9 9 6 3 .7 3 7 2 3 .7 1 4 2 3 .7 4 6 9 3 .5 0 8 9 4.0284 6 3.6892 0.2180 0.2239 0.1834 0.2129 0.2443 0.2512 0.2200 6 0.2226 0.0242 M3 M3 M3 C94503 C94504 C94505 338.4 369.1 337.9 ** CONTINUED ON NEXT PAGE ** 0.0212 0.0174 0.0166 0.5472 0.5608 0 .6 4 1 9 0.2980 0.2408 0.2978 1 .0 2 6 3 1.0039 0.9777 3.7365 3.6000 3.9710 0.2770 0.2056 0.2056 TE 1.0345 0.8243 0.8398 0.8674 0.8535 0.9646 6 0.8974 0.0834 0.8372 0 .8 5 3 6 0.8053 0.8712 0.8758 1.0064 6 0.8749 0.0693 0 .9 7 7 3 0.7623 0.9357 TH 0 .1 4 9 9 0.1579 0.1279 0.1740 0.2713 0.1797 6 0 .1 7 6 8 0.0498 0.1590 0.2175 0.2488 0.2501 0.1673 0.1665 6 0.2015 0 .0 4 2 5 0 .2 0 9 9 0.2387 0 .2 0 3 9 192 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP M 3 C94506 M 3 C94507 M 3 C94508 322.1 298.0 357.8 0.0149 0.0227 0.0158 0.5896 0.6810 0.5830 0.3057 0.2895 0.3090 1.0273 0.9773 0.9435 3.7907 3.7809 3.7597 0.2333 0.2345 0.2306 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 337.2 25.3 6 0.0181 0.0031 6 0.6006 0.0511 6 0.2901 0.0251 6 0.9927 0.0327 6 3.7731 0.1192 6 0.2311 0.0261 M 4 C94509 M 4 C94510 M 4 C94511 M 4 C94512 M 4 C94513 M 4 C94514 NUMBER IN GROUP : MEAN: STANDARD DEV: 301.9 282.3 308.5 365.6 330.7 349.8 6 ' 323.1 31.3 0.0187 0.0169 0.0172 0.0103 0.0163 0.0180 6 0.0162 0.0030 0.7237 0.7107 0.6598 0.5406 0.6735 0.6675 6 0.6626 0.0650 0.3104 0.2646 0.2667 0.2596 0.2521 0.2597 6 0.2688 0.0210 1.0186 1.0436 0.9463 0.8704 1.0858 1.0531 6 1.0030 0.0801 3.3469 3.6665 4.0394 3.8273 4.0334 3.9165 6 3.8050 0.2642 0.1847 0.2521 0.2262 0.1983 0.1996 0.2547 6 0.2193 0.0297 M 5 C94515 M 5 C94516 M 5 C94517 M 5 C94518 331.8 295.2 337.9 316.7 ** CONTINUED ON NEXT PAGE ** 0.0164 0.0154 0.0215 0.0173 0.6596 0.6962 0.5814 0.6375 0.2502 0.2633 0.3260 0.2451 1.0271 1.0711 1.0788 0.9937 5.2612 5.4343 4.5995 6.1710 0.2043 0.2572 0.1874 0.2468 TE 0.8262 1.0808 0.8044 6 0.8978 0.1212 1 .0 110 0.9446 0.8613 0.8536 0.8871 0.8929 6 0.9084 0.0596 0.9127 1.0389 0.9183 0.8785 TH 0.1661 0.1752 0.2225 6 0.2027 0.0277 0.2105 0.1720 0.1917 0.1424 0.1810 0.1946 6 0.1820 0.0234 0.2177 0.2449 0.1482 0.2508 193 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3H T-6314.2 PAGE: 3 TABLE INCLUDES: SEX=ALL ;GROUP=ALL;WEEKS=ALL DEATH=T ;SUBSET==ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP M 5 C94519 M 5 C94520 317.4 325.4 0.0164 0.0149 0.6781 0.6688 0.2462 0.2464 0.9559 1.0317 4.5907 5.2590 0.2245 0.1457 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 320.7 15.0 6 0.0170 0.0023 6 0.6536 0.0404 6 0.2629 0.0316 6 1.0264 0.0465 6 5.2193 0.5890 6 0 .2 1 10 0.0412 M 6 C94521 M 6 C94522 M 6 C94524 M 6 C94525 M 6 C94526 NUMBER IN GROUP: MEAN: STANDARD DEV: 226.3 243.9 211.8 228.0 229.1 5 227.8 11.4 0.0193 0.0301 0.0271 0.0222 0.0260 5 0.0249 0.0042 0.8344 0.7940 0.9333 0.9426 0.8963 5 0.8801 0.0642 0.3018 0.3225 0.3005 0.3410 0.3382 5 0.3208 0.0193 1.0410 1.1868 1.1466 1.11 0 0 1.2016 5 1.1372 0.0646 8.9473 7.9793 8.5011 8.5937 9.0522 5 8.6147 0.4240 0.2672 0.2106 0.2904 0.2992 0.2158 5 0.2566 0.0414 TE 0.8967 0.9232 6 0.9280 0.0567 1.3716 1.3164 1.1755 1.3661 1.3378 5 1.3135 0.0803 TH 0.1735 0.2056 6 0.2068 0.0401 0.2672 0.1640 0.1531 0.1818 0.2189 5 0.1970 0.0465 194 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT M 1 C94491 M 1 C94492 M 1 C94493 M 1 C94494 M 1 C94495 M 1 C94496 335.4 361.6 339.1 379.4 343.5 291.7 0.0066 0.0049 0.0052 0.0079 0.0055 0.0059 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 341.8 29.6 6 0.0060 0.0011 M 2 C94497 M 2 C94498 M 2 C94499 M 2 C94500 M 2 C94501 M 2 C94502 NUMBER IN GROUP : MEAN: STANDARD DEV: 345.7 321.0 384.3 320.2 332.4 ' 323.8 6 337.9 24.7 0.0085 0.0079 0.0056 0.0067 0.0047 0.0084 6 0.0070 0.0016 M 3 C94503 M 3 C94504 M 3 C94505 338.4 369.1 337.9 ** CONTINUED ON NEXT PAGE ** 0.0059 0.0063 0.0068 195 Covance 6329-224 3M T-6314.2 PAGE: 4 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL T E R M I N A L -- - GROUP NUMBER BODY WT (g) TT M 3 C94506 M 3 C94507 M 3 C94508 322.1 298.0 357.8 0.0059 0.0075 0.0079 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 337.2 25.3 6 0.0067 0.0009 M 4 C94509 M 4 C94510 M 4 C94511 M 4 C94512 M 4 C94513 M 4 C94514 NUMBER IN GROUP: MEAN: STANDARD DEV: 301.9 282.3 308.5 365.6 330.7 349.8 6 323.1 31.3 0.0053 0.0068 0.0036 0.0069 0.0065 0.0087 6 0.0063 0.0017 M 5 C94515 M 5 C94516 M 5 C94517 M 5 C94518 331.8 295.2 337.9 316.7 ** CONTINUED ON NEXT PAGE ** 0.0076 0.0068 0.0061 0.0064 Covance 6329-224 3M T-6314.2 PAGE: 5 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT M 5 C94519 M 5 C94520 317.4 325.4 0.0054 0.0085 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 320.7 15.0 6 0.0068 0.0011 M 6 C94521 M 6 C94522 M 6 C94524 M 6 C94525 M 6 C94526 NUMBER IN GROUP: MEAN: STANDARD DEV: 226.3 243.9 211.8 228.0 229.1 5 227.8 11.4 0.0066 0.0071 0.0090 0.0133 0.0075 5 0.0087 0.0027 Covance 6329-224 3M T-6314.2 PAGE: 6 197 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP F 1 C94527 F 1 C94528 F 1 C94529 F 1 C94530 F 1 C94531 F 1 C94532 213.0 210.0 228.8 235.2 207.8 184.7 0.0336 0.0336 0.0447 0.0257 0.0315 0.0369 0.9396 0.9124 0.8404 0.8626 0.9408 1.0321 0.9451 0.9188 1.1477 0.9270 0.9884 0.9519 3.4895 3.7553 3.8407 3.5153 3.6097 3.5910 0.0546 0.0450 0.0620 0.0699 0.0632 0.0623 0.2611 0.1811 0.3014 0.2162 0.2252 0.2411 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 213.3 17.8 6 0.0343 0.0063 6 0.9213 0.0679 6 0.9798 0.0858 6 3.6336 0.1378 6 0.0595 0.0086 6 0.2377 0.0411 F2 F2 F2 F. 2 F2 F2 C94533 C94534 C94535 C94536 C94537 C94538 NUMBER IN GROUP : MEAN: STANDARD DEV: 200.3 197.5 217.3 204.4 223.4 192.6 6 205.9 12.0 0.0319 0.0332 0.0314 0.0393 0.0328 0.0315 6 0.0333 0.0030 1.0181 1.0439 0.9525 0.8906 0.9124 0.9711 6 0.9648 0.0592 0.9514 0.9704 0.8350 0.9791 1.0232 0.9799 6 0.9565 0.0640 4.1602 3.6231 3.5901 3.3572 3.6709 3.6193 6 3.6701 0.2643 0.0700 0.0699 0.0587 0.0707 0.0568 0.0568 6 0.0638 0.0070 0.2522 0.2272 0.2381 0.3101 0.2163 0.2236 6 0.2446 0.0344 F 3 C94539 F 3 C94540 F 3 C94541 217.8 174.2 234.2 ** CONTINUED ON NEXT PAGE ** 0.0500 0.0358 0.0363 0.9235 1.1118 0.8820 1.2341 1.0985 1.0754 3.8482 3.7938 3.7716 0.0668 0.0805 0.0595 0.2537 0.2255 0.2813 Covance 6329-224 3M T-6314.2 PAGE: 7 TE TH 0.2144 0.2863 0.2705 0.2315 0.2598 0.2773 6 0.2566 0.0280 0.2281 0.1962 0.2218 0.2820 0.2338 0.3698 6 0.2553 0.0627 0.2266 0.2269 0.2773 198 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T ;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP F 3 C94542 F 3 C94543 F 3 C94544 242.5 167.9 185.5 0.0363 0.0290 0.0304 0.8267 1.1114 1.0995 1.0461 1.0372 1.1405 3.9152 3.8419 4.4349 0.0645 0.0587 0.0783 0.2264 0.1998 0.2519 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 203.7 32.0 6 0.0363 0.0075 6 0.9925 0.1298 6 1.1053 0.0733 6 3.9342 0.2503 6 0.0681 0.0093 6 0.2398 0.0285 F 4 C94545 F 4 C94546 F 4 C94547 F 4 C94548 F 4 C94549 F 4 C94550 187.2 219.7 237.1 186.8 207.7 187.0 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 204.3 2 1 .1 F 5 C94551 F 5 C94552 F 5 C94553 F 5 C94554 171.1 201.4 206.3 184.4 ** CONTINUED ON NEXT PAGE ** 0.0313 0.0289 0.0335 0.0287 0.0314 0.0337 6 0.0312 0.0022 0.0386 0.0328 0.0329 0.0316 1.0060 0.9328 0.9067 1.1231 0.9903 1.0181 6 0.9962 0.0758 1.1020 1.0194 0.9835 1.0274 1.0764 0.9710 0.9526 1.0181 1.0318 1.0132 6 1.0105 0.0442 1.1350 1.1459 1.0708 1.0522 3.8315 4.3590 4.1498 3.6846 4.2154 4.1186 6 4.0598 0.2523 5.1380 5.0835 5.0851 4.7060 0.0656 0.0458 0.0564 0.0503 0.0788 0.0513 6 0.0580 0.0122 0.0753 0.0623 0.0527 0.0527 0.2479 0.2654 0.2357 0.2170 0.2477 0.2308 6 0.2407 0.0167 0.2640 0.2369 0.2214 0.1939 Covance 6329-224 3M T-6314.2 PAGE: 8 TE TH 0.2506 0.3313 0.2641 6 0.2628 0.0391 0.2517 0.2925 0.2525 0.3362 0.2137 0.2706 6 0.2695 0.0417 0.1847 0.1980 0.2952 0.2012 199 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL ;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) F 5 C94555 F 5 C94556 192.5 206.1 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 193.6 13.9 : AD - ADRENAL BR - BRAIN, EP - EPIDIDYMIDES : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS AD 0.0314 0.0377 6 0.0342 0.0032 BR 1.0766 1.0139 6 1.0372 0.0438 EP KD LI OV SP 1.1216 1.2633 5.2079 4.5820 0.0534 0.0655 0.2568 0.2951 6 1.1315 0.0744 6 4.9671 0.2573 6 0.0603 0.0092 6 0.2447 0.0353 F 6 C94557 F 6 C94558 F 6 C94559 F 6 C94560 F 6 C94561 F 6 C94562 NUMBER IN GROUP: MEAN: STANDARD DEV: 151.5 154.4 134.5 172.6 161.3 165.1 6 156.6 13.2 0.0251 0.0293 0.0261 0.0225 0.0383 0.0357 6 0.0295 0.0062 1.2825 1.3666 1.3369 1.2123 1.2195 1.2365 6 1.2757 0.0644 1.1207 1.1079 1.0488 0.9717 1.2182 1.1449 6 1 .10 2 1 0.0843 8.2434 8.2163 7.3432 8.6498 8.2650 6.6418 6 7.8932 0.7492 0.0500 0.0503 0.0380 0.0389 0.0494 0.0645 6 0.0485 0.0097 0.2075 0.2823 0.3193 0.3064 0.2555 0.2654 6 0.2727 0.0400 Covance 6329-224 3M T-6314.2 PAGE: 9 TE TH 0.4262 0.2533 6 0.2598 0.0915 0.2228 0.2756 0.3080 0.3747 0.2542 0.3136 6 0.2915 0.0530 200 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT F 1 C94527 F 1 C94528 F 1 C94529 F 1 C94530 F 1 C94531 F 1 C94532 213.0 210.0 228.8 235.2 207.8 184.7 0.0073 0.0067 0.0077 0.0057 0.0083 0.0095 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 213.3 17.8 6 0.0075 0.0013 F 2 C94533 F 2 C94534 F 2 C94535 F 2 C94536 F 2 C94537 F 2 C94538 NUMBER IN GROUP : MEAN: STANDARD DEV: 200.3 197.5 217.3 204.4 223.4 192.6 6 205.9 12.0 0.0098 0.0110 0.0090 0.0068 0.0086 0.0074 6 0.0088 0.0015 F 3 C94539 F 3 C94540 F 3 C94541 217.8 174.2 234.2 ** CONTINUED ON NEXT PAGE ** 0.0030EX 0.0125 0.0070 201 Covance 6329-224 3M T-6314.2 PAGE: 10  APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T; SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT F 3 C94542 F 3 C94543 F 3 C94544 242.5 167.9 185.5 0.0103 0.0114 0.0075 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 203.7 32.0 5 0.0098 0.0024 F 4 C94545 F 4 C94546 F 4 C94547 F 4 C94548 F 4 C94549 F 4 C94550 NUMBER IN GROUP: MEAN: STANDARD DEV: 187.2 219.7 237.1 186.8 207.7 187.0 6 ' 204.3 2 1 .1 0.0070 0.0133 0.0054 0.0089 0.0106 0.0088 6 0.0090 0.0028 F 5 C94551 F 5 C94552 F 5 C94553 F 5 C94554 171.1 201.4 206.3 184.4 ** CONTINUED ON NEXT PAGE ** 0.0074 0.0121 0.0115 0.0081 202 Covance 6329-224 3M T-6314.2 PAGE: 11 APPENDIX 6 Individual Organ-to-Body Weight Percentages Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT F 5 C94555 F 5 C94556 192.5 206.1 0.0092 0.0073 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 193.6 13.9 6 0.0093 0.0021 F 6 C94557 F 6 C94558 F 6 C94559 F 6 C94560 F 6 C94561 F 6 C94562 NUMBER IN GROUP : MEAN: STANDARD DEV: 151.5 154.4 134.5 172.6 161.3 165.1 6 156.6 13.2 0.0100 0.0079 0.0088 0.0055 0.0113 0.0093 6 0.0088 0.0020 Covance 6329-224 3M T-6314.2 PAGE: 12 203 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFQNAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 1 TABLE INCLUDES: SEX=ALL ;GROUP=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T ;SUBSET^ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD o> H SP M 1 C94491 M 1 C94492 M 1 C94493 M 1 C94494 M 1 C94495 M 1 C94496 335.4 361.6 339.1 379.4 343.5 291.7 0.0290 0.0260 0.0293 0.0299 0.0189 0.0360 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 0.4902 0.4427 0.4543 0.4787 0.3842 0.4373 1.7113 1.6402 1.9030 1.7690 1.4570 1.4429 6.6515 6.8996 6.4565 6.7562 6.0595 4.7975 0.4394 0.3788 0.3903 0.3695 0.3696 0.3987 NUMBER IN GROUP MEAN STANDARD DEV 6 341.8 29.6 6 0.0282 0.0056 6 1.0000 0.0000 6 0.4479 0.0374 6 1.6539 0.1800 6 6.2701 0.7779 6 0.3911 0.0264 M 2 C94497 M 2 C94498 M 2 C94499 M 2 C94500 M 2 C94501 M 2 C94502 NUMBER IN GROUP MEAN STANDARD DEV 345.7 321.0 384.3 320.2 332.4 - 323.8 6 337.9 24.7 0.0307 0.0308 0.0217 0.0271 0.0300 0.0283 6 0.0281 0.0035 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 6 1.0000 0.0000 0.4762 0.4632 0.3961 0.3992 0.4697 0.4471 6 0.4419 0.0357 1.3637 1.3741 1.6728 1.6832 1.4810 1.5536 6 1.5214 0.1402 6.2406 5.8628 6.8319 5.6477 5.6379 6.5240 6 6.1241 0.4911 0.4111 0.2878 0.3917 0.3682 0.4036 0.3563 6 0.3698 0.0453 M 3 C94503 M 3 C94504 M 3 C94505 338.4 369.1 337.9 ** CONTINUED ON NEXT PAGE ** 0.0388 0.0311 0.0259 1.0000 1.0000 1.0000 0.5446 0.4294 0.4639 1.8756 1.7902 1.5233 6.8284 6.4197 6.1865 0.5061 0.3667 0.3203 TE 1.6438 1.5022 1.4818 1.5496 1.3335 1.3973 6 1.4847 0.1098 1.5369 1.3391 1.4812 1.3132 1.4071 1.6298 6 1.4512 0.1214 1.7860 1.3593 1.4578 TH 0.2381 0.2878 0.2256 0.3108 0.4238 0.2603 6 0.2911 0.0722 0.2918 0.3413 0.4576 0.3769 0.2689 0.2696 6 0.3343 0.0739 0.3836 0.4257 0.3177 204 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL - GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP M 3 C94506 M 3 C94507 M 3 C94508 322.1 298.0 357.8 0.0252 0.0333 0.0272 1.0000 1.0000 1.0000 0.5185 0.4251 0.5299 1.7425 1.4352 1.6182 6.4297 5.5520 6.4484 0.3957 0.3444 0.3955 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 337.2 25.3 6 0.0303 0.0052 6 1.0000 0.0000 6 0.4852 0.0526 6 1.6641 0.1680 6 6.3108 0.4252 6 0.3881 0.0648 M 4 C94509 M 4 C94510 M 4 C94511 M 4 C94512 M 4 C94513 M 4 C94514 NUMBER IN GROUP: MEAN: STANDARD DEV: 301.9 282.3 308.5 365.6 330.7 349.8 6 ' 323.1 31.3 0.0259 0.0238 0.0260 0.0191 0.0242 0.0270 6 0.0243 0.0028 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 6 1.0000 0.0000 0.4289 0.3724 0.4042 0.4802 0.3743 0.3890 6 0.4082 0.0411 1.4075 1.4684 1.4342 1.6102 1.6121 1.5777 6 1.5184 0.0923 4.6244 5.1589 6.1224 7.0802 5.9886 5.8677 6 5.8070 0.8457 0.2552 0.3547 0.3428 0.3669 0.2963 0.3816 6 0.3329 0.0479 M 5 C94515 M 5 C94516 M 5 C94517 M 5 C94518 331.8 295.2 337.9 316.7 ** CONTINUED ON NEXT PAGE ** 0.0249 0.0222 0.0369 0.0272 1.0000 1.0000 1.0000 1.0000 0.3794 0.3782 0.5606 0.3845 1.5571 1.5385 1.8555 1.5587 7.9757 7.8056 7.9109 9.6804 0.3097 0.3694 0.3223 0.3872 TE 1.4013 1.5871 1.3796 6 1.4952 0.1644 1.3968 1.3291 1.3055 1.5790 1.3172 1.3378 6 1.3776 0.1037 1.3836 1.4922 1.5794 1.3780 TH 0.2817 0.2573 0.3817 6 0.3413 0.0659 0.2908 0.2420 0.2905 0.2635 0.2688 0.2916 6 0.2745 0.0201 0.3300 0.3517 0.2550 0.3934 205 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-224 3M T-6314.2 PAGE: 3 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP M 5 C94519 M 5 C94520 317.4 325.4 0.0243 0.0223 1.0000 1.0000 0.3631 0.3684 1.4095 1.5425 6.7696 7.8629 0.3311 0.2178 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 320.7 15.0 6 0.0263 0.0055 6 1.0000 0.0000 6 0.4057 0.0763 6 1.5770 0.1476 6 8.0008 0.9384 6 0.3229 0.0593 M 6 C94521 M 6 C94522 M 6 C94524 M 6 C94525 M 6 C94526 NUMBER IN GROUP: MEAN: STANDARD DEV: 226.3 243.9 211.8 228.0 229.1 5 227.8 11.4 0.0231 0.0380 0.0290 0.0236 0.0290 5 0.0285 0.0060 1.0000 1.0000 1.0000 1.0000 1.0000 5 1.0000 0.0000 0.3617 0.4062 0.3220 0.3618 0.3773 5 0.3658 0.0305 1.2475 1.4946 1.2286 1.1776 1.3406 5 1.2978 0.1248 10.7227 10.0493 9.1088 9.1167 10.0991 5 9.8193 0.6974 0.3202 0.2653 0.3112 0.3174 0.2407 5 0.2909 0.0359 TE 1.3223 1.3803 6 1.4226 0.0946 1.6438 1.6579 1.2595 1.4492 1.4926 5 1.5006 0.1628 TH 0.2559 0.3074 6 0.3156 0.0545 0.3202 0.2065 0.1641 0.1929 0.2442 5 0.2256 0.0603 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL - GROUP NUMBER BODY WT (g) TT M 1 C94491 M 1 C94492 M 1 C94493 M 1 C94494 M 1 C94495 M 1 C94496 335.4 361.6 339.1 379.4 343.5 291.7 0.0106 0.0089 0.0092 0.0141 0.0086 0.0085 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 341.8 29.6 6 0.0100 0.0021 M 2 C94497 M 2 C94498 M 2 C94499 M 2 C94500 M 2 C94501 M 2 C94502 NUMBER IN GROUP: MEAN: STANDARD DEV: 345.7 321.0 384.3 320.2 332.4 323.8 6 337.9 24.7 0.0157 0.0123 0.0103 0.0100 0.0075 0.0137 6 0.0116 0.0029 M 3 C94503 M 3 C94504 M 3 C94505 338.4 369.1 337.9 ** CONTINUED ON NEXT PAGE ** 0.0107 0 .0 11 2 0.0106 207 Covance 6329-224 3M T-6314.2 PAGE: 4 i APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT M 3 C94506 M 3 C94507 M 3 C94508 322.1 298.0 357.8 0.0100 0.0110 0.0135 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 337.2 25.3 6 0.0112 0.0012 M 4 C94509 M 4 C94510 M 4 C94511 M 4 C94512 M 4 C94513 M 4 C94514 NUMBER IN GROUP: MEAN: STANDARD DEV: 301.9 282.3 308.5 365.6 330.7 349.8 6 323.1 31.3 0.0073 0.0096 0.0055 0.0129 0.0097 0.0130 6 0.0097 0.0030 M 5 C94515 M 5 C94516 M 5 C94517 M 5 C94518 331.8 295.2 337.9 316.7 ** CONTINUED ON NEXT PAGE ** 0.0115 0.0098 0.0105 0.0101 208 Covance 6329-224 3M T-6314.2 PAGE: 5 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT M 5 C94519 M 5 C94520 317.4 325.4 0.0080 0.0128 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 320.7 15.0 6 0.0104 0.0016 M C94521 M 6 C94522 M 6 C94524 M 6 C94525 M 6 C94526 NUMBER IN GROUP : MEAN: STANDARD DEV 226.3 243.9 211.8 228.0 229.1 5 227.8 11.4 0.0079 0.0089 0.0097 0.0141 0.0084 5 0.0098 0.0025 Covance 6329-224 3M T-6314.2 PAGE: 6 209 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL : AD - ADRENAL, BR - BRAIN, EP - EPIDIDYMIDES DEATH=T;SUBSET=ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP F 1 C94527 F 1 C94528 F 1 C94529 F 1 C94530 F 1 C94531 F 1 C94532 213.0 210.0 228.8 235.2 207.8 184.7 0.0357 0.0368 0.0532 0.0298 0.0335 0.0358 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 1.0058 1.0070 1.3657 1.0746 1.0505 0.9224 3.7139 4.1160 4.5702 4.0753 3.8368 3.4795 0.0581 0.0493 0.0737 0.0810 0.0672 0.0603 0.2779 0.1985 0.3586 0.2506 0.2393 0.2336 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 213.3 17.8 6 0.0375 0.0081 6 1.0000 0.0000 6 1.0710 0.1534 6 3.9653 0.3785 6 0.0650 0.0114 6 0.2598 0.0548 F 2 C94533 F 2 C94534 F 2 C94535 F 2 C94536 F 2 C94537 F 2 C94538 NUMBER IN GROUP : MEAN: STANDARD DEVs 200.3 197.5 217.3 204.4 223.4 . 192.6 6 205.9 12.0 0.0313 0.0318 0.0330 0.0441 0.0360 0.0324 6 0.0348 0.0049 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 6 1.0000 0.0000 0.9344 0.9296 0.8767 1.0994 1.1214 1.0091 6 0.9951 0.0990 4.0862 3.4707 3.7691 3.7698 4.0232 3.7270 6 3.8077 0.2222 0.0687 0.0669 0.0616 0.0794 0.0623 0.0585 6 0.0663 0.0075 0.2477 0.2176 0.2500 0.3482 0.2371 0.2303 6 0.2551 0.0471 F 3 C94539 F 3 C94540 F 3 C94541 217.8 174.2 234.2 ** CONTINUED ON NEXT PAGE ** 0.0542 0.0322 0.0411 1.0000 1.0000 1.0000 1.3363 0.9881 1.2193 4.1671 3.4124 4.2760 0.0723 0.0724 0.0675 0.2747 0.2029 0.3190 Covance 6329-224 3M T-6314.2 PAGE: 7 TE TH 0.2282 0.3138 0.3218 0.2684 0.2761 0.2686 6 0.2795 0.0342 0.2240 0.1879 0.2328 0.3167 0.2562 0.3808 6 0.2664 0.0704 0.2454 0.2041 0.3144 210 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL ;GROUP=ALL;WEEKS=ALL : AD - ADRENAL BR - BRAIN, EP - EPIDIDYMIDES DEATH=T ;SUBSET= ALL : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) AD BR EP KD LI OV SP F 3 C94542 F 3 C94543 F 3 C94544 242.5 167.9 185.5 0.0439 0.0261 0.0276 1.0000 1.0000 1.0000 1.2654 0.9332 1.0373 4.7358 3.4569 4.0337 0.0781 0.0528 0.0712 0.2738 0.1797 0.2291 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 203.7 32.0 6 0.0375 0.0109 6 1.0000 0.0000 6 1.1299 0.1651 6 4.0137 0.5071 6 0.0691 0.0086 6 0.2466 0.0519 F 4 C94545 F 4 C94546 F 4 C94547 F 4 C94548 F 4 C94549 F 4 C94550 NUMBER IN GROUP: MEAN: STANDARD DEV: 187.2 219.7 237.1 186.8 207.7 187.0 6 204.3 2 1 .1 0.0311 0.0309 0.0369 0.0255 0.0317 0.0331 6 0.0316 0.0037 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 6 1.0000 0.0000 1.0700 1.0409 1.0506 0.9065 1.0419 0.9952 6 1.0175 0.0597 3.8087 4.6732 4.5766 3.2806 4.2566 4.0454 6 4.1069 0.5175 0.0652 0.0491 0.0622 0.0448 0.0795 0.0504 6 0.0586 0.0130 0.2464 0.2845 0.2599 0.1932 0.2501 0.2267 6 0.2435 0.0310 F 5 C94551 F 5 C94552 F 5 C94553 F 5 C94554 171.1 201.4 206.3 184.4 ** CONTINUED ON NEXT PAGE ** 0.0351 0.0321 0.0335 0.0307 1.0000 1.0000 1.0000 1.0000 1.0299 1.1241 1.0888 1.0241 4.6625 4.9867 5.1703 4.5803 0.0684 0.0611 0.0536 0.0513 0.2396 0.2324 0.2251 0.1887 Covance 6329-224 3M T-6314.2 PAGE: 8 TE TH 0.3032 0.2981 0.2402 6 0.2676 0.0440 0.2502 0.3136 0.2785 0.2993 0.2158 0.2658 6 0.2705 0.0352 0.1676 0.1942 0.3001 0.1959 211 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) F 5 C94555 F 5 C94556 192.5 206.1 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 193.6 13.9 : AD - ADRENAL BR - BRAIN, EP - EPIDIDYMIDES : KD - KIDNEY, LI - LIVER, OV - OVARY ORGAN ABBREVIATION: SP - SPLEEN, TE - TESTIS, TH - THYMUS AD 0.0292 0.0372 6 0.0330 0.0029 BR 1.0000 1.0000 6 1.0000 0.0000 EP KD LI OV SP 1.0418 1.2459 4.8372 4.5191 0.0496 0.0646 0.2386 0.2910 6 1.0924 0.0845 6 4.7927 0.2526 6 0.0581 0.0077 6 0.2359 0.0329 F 6 C94557 F 6 C94558 F 6 C94559 F 6 C94560 F 6 C94561 F 6 C94562 NUMBER IN GROUP: MEAN: STANDARD DEV: 151.5 154.4 134.5 172.6 161.3 165.1 6 156.6 13.2 0.0196 0.0215 0.0195 0.0186 0.0314 0.0289 6 0.0232 0.0055 1.0000 1.0000 1.0000 1.0000 1.0000 1.0000 6 1.0000 0.0000 0.8739 0.8107 0.7846 0.8015 0.9990 0.9259 6 0.8659 0.0839 6.4275 6.0120 5.4928 7.1348 6.7776 5.3713 6 6.2027 0.7044 0.0390 0.0368 0.0284 0.0321 0.0405 0.0522 6 0.0382 0.0082 0.1618 0.2065 0.2389 0.2528 0.2096 0.2146 6 0.2140 0.0314 Covance 6329-224 3M T-6314.2 PAGE: 9 TE TH 0.3959 0.2498 6 0.2506 0.0856 0.1738 0.2017 0.2304 0.3091 0.2084 0.2536 6 0.2295 0.0474 212 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT F 1 C94527 F 1 C94528 F 1 C94529 F 1 C94530 F 1 C94531 F 1 C94532 213.0 210.0 228.8 235.2 207.8 184.7 0.0077 0.0074 0.0092 0.0066 0.0088 0.0092 NUMBER IN GROUP: MEAN: STANDARD DEV: 6 213.3 17.8 6 0.0081 0.0011 F 2 C94533 F 2 C94534 F 2 C94535 F 2 C94536 ' F 2 C94537 F 2 C94538 NUMBER IN GROUP : MEAN: STANDARD DEV: 200.3 197.5 217.3 204.4 223.4 192.6 6 205.9 12.0 0.0097 0.0105 0.0095 0.0077 0.0094 0.0076 6 0.0091 0.0012 F 3 C94539 F 3 C94540 F 3 C94541 217.8 174.2 234.2 * CONTINUED ON NEXT PAGE ** 0.033EX 0.0112 0.0079 213 Covance 6329-224 3M T-6314.2 PAGE: 10 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT F 3 C94542 F 3 C94543 F 3 C94544 242.5 167.9 185.5 0.0125 0.0103 0.0069 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 203.7 32.0 5 0.0098 0.0023 F 4 C94545 F 4 C94546 F 4 C94547 F 4 C94548 F 4 C94549 F 4 C94550 NUMBER IN GROUP: MEAN: STANDARD DEV: 187.2 219.7 237.1 186.8 207.7 187.0 6 204.3 2 1 .1 0.0070 0.0143 0.0060 0.0080 0.0107 0.0087 6 0.0091 0.0030 F 5 C94551 F 5 C94552 F 5 C94553 F 5 C94554 171.1 201.4 206.3 184.4 ** CONTINUED ON NEXT PAGE ** 0.0067 0.0119 0.0117 0.0079 214 Covance 6329-224 3M T-6314.2 PAGE: 11 APPENDIX 6 Individual Organ-to-Brain Weight Ratios Terminal Sacrifice 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ORGAN ABBREVIATION: TT - THYROID/PARATHYR SEX DOSE ANIMAL TERMINAL GROUP NUMBER BODY WT (g) TT F 5 C94555 F 5 C94556 192.5 206.1 0.0085 0.0072 NUMBER IN GROUP : MEAN: STANDARD DEV: 6 193.6 13.9 6 0.0090 0.0023 F 6 C94557 F 6 C94558 F 6 C94559 F 6 C94560 F 6 C94561 F 6 C94562 NUMBER IN GROUP: MEAN: STANDARD DEV: 151.5 154.4 134.5 172.6 161.3 165.1 6 156.6 13.2 0.0078 0.0058 0.0066 0.0045 0.0093 0.0075 6 0.0069 0.0017 Covance 6329-224 3M T-6314.2 PAGE: 12 215 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 1 ANIMAL NUMBER: C94491 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 335.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:01 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0612 2.1109 1.0347 3.6123 14.0407 .9276 3.4698 .5026 .0223 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0182 % .6294 % .3085 % 1.0770 % 4.1863 % .2766 % 1.0345 % .1499 % .0066 % ORGAN TO BRAIN WEIGHT RATIO .0290 1.0000 .4902 1.7113 6.6515 .4394 1.6438 .2381 .0106 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL 216 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 2 ANIMAL NUMBER: C94491 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 335.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:01 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST^-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST) , STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 217 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 3 ANIMAL NUMBER: C94492 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 361.6 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:46 PROSECTOR: TERRI L. WILLIAMS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST : HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0515 1.9843 .8785 3.2546 13.6908 .7517 2.9808 .5711 .0177 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0142 % .5488 % .2429 % .9001 % 3.7862 % .2079 % .8243 % .1579 % .0049 % ORGAN TO BRAIN WEIGHT RATIO .0260 1.0000 .4427 1.6402 6.8996 .3788 1.5022 .2878 .0089 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 4 ANIMAL NUMBER: C94492 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 361.6 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:46 PROSECTOR: TERRI L. WILLIAMS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) ,KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE,STERNUM (SB) , LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) ,PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), TESTIS (TE) 219 li Covance 6329-224 3M T-6314.2 APPENDIX 6 Individual Animal Pathology Data 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 5 ANIMAL NUMBER: C94493 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 339.1 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:30 PROSECTOR: TERRI L. WILLIAMS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0563 1.9218 .8731 3.6572 12.4081 .7500 2.8478 .4336 .0177 .0166 % .5667 % .2575 % 1.0785 % 3.6591 % .2212 % .8398 % .1279 % .0052 % .0293 1.0000 .4543 1.9030 6.4565 .3903 1.4818 .2256 .0092 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY STOMACH, GL (ST) : -DARK FOCUS (I)/AREA(S); MUCOSA: MULTIPLE BROWN AREAS, UP TO 1 MM IN DIAMETER GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL ADRENAL, CORTEX (AC) : -VACUOLATION,-MINIMAL STOMACH, GL (ST) : UNREMARKABLE APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 6 ANIMAL NUMBER: C94493 SEX: MALE DATE OF DEATH: 07/13/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 07/13/98 10:30 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 1 SACRIFICE STATUS: DEATH: 32 STUDY WEEK OF DEATH: 5 PROSECTOR: TERRI L. WILLIAMS PATHOLOGIST: HAMP, BRUNER SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 339.1 GRAMS RECORDER: JODI THIEREN WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: (SU), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), LN POPLITEAL (PP) CECUM fCFl rnrnN frrn ^CTUM RE), THYROID (TY) , PARATHYROID {PT) , AORTA (AO) , PITUITARY (PI), THYMUS (T a f spiNAL'C M D ^ r ? '' HARDERiAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, mAn DIB (SG) , LN MANDIBULAR (MN) SKTN 722? ` K URTNARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDliyMIDES(EP) '` THE FOLLOWING TISSUES WERE EYE (EY), KIDNEY (KD), STOMACH, NONGL (SU) UNREMARKABLE SPLEEN (SP), AT MICROSCOPIC PANCREAS (PA), EXAMINATION: LN, MESENTERIC (MS), ADRENAL, MEDULLA (MA), TESTIS (TE), 221 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 7 ANIMAL NUMBER: C94494 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 379.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:02 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST : HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0634 2.1238 1.0167 3.7571 14.3488 .7848 3.2911 .6600 .0299 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0167 % .5598 % .2680 % .9903 % 3.7820 % .2069 % .8674 % .1740 % .0079 % ORGAN TO BRAIN WEIGHT RATIO .0299 1.0000 .4787 1.7690 6.7562 .3695 1.5496 .3108 .0141 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -DEGENERATION, TUBULAR,-MINIMAL -HYALINE DROPLETS, TUBULAR EPITHELIUM,-SLIGHT LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL ADRENAL, CORTEX (AC) : -VACUOLATION,-MINIMAL APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 '4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 8 ANIMAL NUMBER: C94494 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 379.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:02 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), LN, POPLITEAL (PP), CECUM (CE), COLON (CO), RECTUM (RE), THYROID (TY), PARATHYROID (PT), AORTA (AO), PITUITARY (PI), THYMUS (TH), SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, MEDULLA (MA) , TESTIS (TE) 223 APPENDIX 6 individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 9 ANIMAL NUMBER: C94495 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 343.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:26 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0416 2.1985 .8446 3.2033 13.3219 .8125 2.9317 .9318 .0189 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0121 % .6400 % .2459 % .9325 % 3.8783 % .2365 % .8535 % .2713 % .0055 % ORGAN TO BRAIN WEIGHT RATIO .0189 1.0000 .3842 1.4570 6.0595 .3696 1.3335 .4238 .0086 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL 224 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 10 ANIMAL NUMBER: C94495 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 343.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:26 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), TESTIS (TE), BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 225 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 11 ANIMAL NUMBER: C94496 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 291.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:34 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0725 2.0137 .8805 2.9056 9.6607 .8029 2.8137 .5241 .0172 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0249 % .6903 % .3019 % .9961 % 3.3119 % .2752 % .9646 % .1797 % .0059 % ORGAN TO BRAIN WEIGHT RATIO .0360 1.0000 .4373 1.4429 4.7975 .3987 1.3973 .2603 .0085 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL 226 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 12 ANIMAL NUMBER: C94496 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 291.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:34 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 227 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE- 13 ANIMAL NUMBER: C94497 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 345.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:23 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0579 1.8832 .8967 2.5682 11.7523 .7741 2.8943 .5496 .0295 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0167 % .5447 % .2594 % .7429 % 3.3996 % .2239 % .8372 % .1590 % .0085 % ORGAN TO BRAIN WEIGHT RATIO .0307 1.0000 .4762 1.3637 6.2406 .4111 1.5369 .2918 .0157 Organ STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL KIDNEY (KD) : -INFLAMMATION, CHRONIC,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL APPENDIX 6 individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 14 ANIMAL NUMBER: C94497 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 345.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:23 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (E Y ), BRAIN (BR) , KIDNEY (KD) , L IV ER ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E S T IS (TE ) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG (L U ), TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN ) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU) , DUODENUM (D U ), JEJUNUM (J E ) , ILEUM ( I L ) , LN , PO PLITEA L (P P ) , CECUM (CE) , COLON (C O ), RECTUM ( R E ), THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PITU ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ) , SALIV G L, MANDIB (SG ) , LN, MANDIBULAR (MN) , SKIN (SK ) , URINARY BLADDER (UB) , PROSTATE ( P R ) , SEMINAL V E SIC L E S (S V ) , E PID ID Y M ID ES (E P ) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (E Y ), SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E STIS (TE) 229 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 15 ANIMAL NUMBER: C94498 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 321.0 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:20 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0630 2.0462 .9478 2.8116 11.9965 .5888 2.7400 .6983 .0252 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0196 % .6374 % .2953 % .8759 % 3.7372 % .1834 % .8536 % .2175 % .0079 % ORGAN TO BRAIN WEIGHT RATIO .0308 1.0000 .4632 1.3741 5.8628 .2878 1.3391 .3413 .0123 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN , BRAIN (BR) : -VACUOLATION,-MINIMAL 230 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 16 ANIMAL NUMBER: C94498 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 321.0 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:20 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV ER ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN , MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E S T IS (TE ) , BONE, FEMUR (FE ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG ( L U ) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEA L ( P P ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ), THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PITU ITA R Y ( P I ) , THYMUS (TH) , SPINA L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ) , SA L IV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SK IN (SK ) , URINARY BLADDER (U B ), PROSTATE ( P R ) , SEMINAL V E SIC L E S ( S V ) , E PID ID Y M ID ES (E P ) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , LIVER ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (M A), T E S T IS (TE) 231 > Covance 6329-224 3M T-6314.2 APPENDIX 6 Individual Animal Pathology Data 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 17 ANIMAL NUMBER: C94499 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 384.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:48 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0454 2.0893 .8275 3.4950 14.2738 .8183 3.0946 .9560 .0216 .0118 % .5437 % .2153 % .9094 % 3.7142 % .2129 % .8053 % .2488 % .0056 % .0217 1.0000 .3961 1.6728 6.8319 .3917 1.4812 .4576 .0103 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -INFLAMMATION, CHR O N IC,-SLIG H T LIVER (L I) : -INFLAMMATION, SUBACUTE, -MINIMAL 232 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 18 ANIMAL NUMBER: C94499 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 384.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:48 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 233 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 19 ANIMAL NUMBER: C94500 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 320.2 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:29 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0575 2.1243 .8480 3.5756 11.9975 .7821 2.7896 .8007 .0213 .0180 % .6634 % .2648 % 1.1167 % 3.7469 % .2443 % .8712 % .2501 % .0067 % .0271 1.0000 .3992 1.6832 5.6477 .3682 1.3132 .3769 .0100 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL KIDNEY (KD) : -HYALINE DROPLETS, TUBULAR EPITHELIUM,-MINIMAL -PYELITIS,-MODERATE LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL ADRENAL, CORTEX (AC) : -VACUOLATION, -MINIMAL 234 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 20 ANIMAL NUMBER: C94500 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 320.2 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:29 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E S T IS (T E ) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM (SB ) , LUNG (LU) , TRACHEA (TR ) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEAL ( P P ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ), THYROID (TY) , PARATHYROID (P T ) , AORTA (AO) , P IT U ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SA LIV G L, MANDIB (SG) , LN, MANDIBULAR (MN) , SK IN (SK ) , URINARY BLADDER ( U B ), PROSTATE ( P R ) , SEMINAL V E SIC L E S ( S V ) , EPIDIDYM IDES (E P ) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE ( E Y ) , SPLEEN ( S P ) , PANCREAS ( P A ), LN, MESENTERIC (M S ), ADRENAL, MEDULLA (M A ), T E S T IS (T E ) 235 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 21 ANIMAL NUMBER: C94501 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 332.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:14 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0621 2.0688 .9718 3.0639 11.6636 .8350 2.9111 .5562 .0155 .0187 % .6224 % .2924 % .9218 % 3.5089 % .2512 % .8758 % .1673 % .0047 % .0300 1.0000 .4697 1.4810 5.6379 .4036 1.4071 .2689 .0075 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -HYALINE DROPLETS, TUBULAR EPITHELIUM,-MINIMAL APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 22 ANIMAL NUMBER: C94501 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 332.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:14 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE,STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR(MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 237 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 23 ANIMAL NUMBER: C94502 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 323.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:18 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0565 1.9994 .8940 3.1062 13.0440 .7124 3.2586 .5391 .0273 .0174 % .6175 % .2761 % .9593 % 4.0284 % .2200 1.0064 % .1665 % .0084 % .0283 1.0000 .4471 1.5536 6.5240 .3563 1.6298 .2696 .0137 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN EYE (EY) : -VASCULARIZATION, CORNEAL, -MINIMAL BRAIN (BR) : -V A C U O L A T IO N ,-M IN IM A L LIVER (L I) : - INFLAMMATION, SUBACUTE, -MINIMAL 238 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 24 ANIMAL NUMBER: C94502 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH:i: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 323.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:18 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), LN, POPLITEAL (PP), CECUM (CE), COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 239 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE- 25 ANIMAL NUMBER: C94503 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 338.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:27 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0719 1.8517 1.0084 3.4730 12.6442 .9372 3.3072 .7104 .0198 ORGAN WEIGHT RELATIVE TO BODY WEIGHT <%) .0212 % .5472 % .2980 % 1.0263 % 3.7365 % .2770 % .9773 % .2099 % .0059 % ORGAN TO BRAIN WEIGHT RATIO .0388 1.0000 .5446 1.8756 6.8284 .5061 1.7860 .3836 .0107 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY SKIN (SK) : ' -CRUSTED AREA (S) ; BILATERAL, SHOULDER REGION: TWO DRY, RED, CRUSTED AREAS, LEFT IS 12 X 9 MM (CAP 21), RIGHT IS 10 X 4 MM (CAP 22) GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL SKIN (SK) : -INFLAMMATION, CHRONIC-ACTIVE,-MODERATE >NOTE:>WITH ACANTHOSIS. APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 26 ANIMAL NUMBER: C94503 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 338.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:27 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E S T IS (TE) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG (L U ), TRACHEA (T R ) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN ) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, POPLITEAL (P P ) , CECUM (CE) , COLON ( C O ) , RECTUM ( R E ) , THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PIT U ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ), SALIV G L , MANDIB (SG ) , LN, MANDIBULAR (MN) , URINARY BLADDER (UB) , PROSTATE ( P R ) , SEMINAL VESICLES (SV) , EPIDIDYM IDES (EP) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (S P ) , PANCREAS ( P A ), LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , TESTIS (TE) 241 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 27 ANIMAL NUMBER: C94504 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 369.1 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:13 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0644 2.0698 .8887 3.7053 13.2875 .7590 2.8135 .8812 .0231 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0174 % .5608 % .2408 % 1.0039 % 3.6000 % .2056 % .7623 % .2387 % .0063 % ORGAN TO BRAIN WEIGHT RATIO .0311 1.0000 .4294 1.7902 6.4197 .3667 1.3593 .4257 .0 112 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL ADRENAL, CORTEX (AC) : -VACUOLATION,-MINIMAL APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 28 ANIMAL NUMBER: C94504 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 369.1 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:13 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY), BRAIN (BR), KIDNEY (KD), LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, MEDULLA (MA) , TESTIS (TE) 243 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 29 ANIMAL NUMBER: C94505 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 337.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:38 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0562 2.1689 1.0062 3.3038 13.4179 .6947 3.1618 .6890 .0230 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0166 % .6419 % .2978 % .9777 % 3.9710 % .2056 % .9357 % .2039 % .0068 % ORGAN TO BRAIN WEIGHT RATIO .0259 1.0000 .4639 1.5233 6.1865 .3203 1.4578 .3177 .0106 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN EYE (EY) : -ONE EXAMINED,-PRESENT >NOTE: >ONE OF PA IR PRESENT. 244 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 30 ANIMAL NUMBER: C94505 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 337.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:38 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), TESTIS (TE) 245 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 31 ANIMAL NUMBER: C94506 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 322.1 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 12:53 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0479 1.8990 .9847 3.3090 12.2100 .7515 2.6611 .5349 .0189 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0149 % .5896 % .3057 % 1.0273 % 3.7907 % .2333 % .8262 .1661 % .0059 % ORGAN TO BRAIN WEIGHT RATIO .0252 1.0000 .5185 1.7425 6.4297 .3957 1.4013 .2817 .0100 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN EYE (EY) : -ONE EXAMINED,-PRESENT >NOTE:>ONE OF PAIR PRESENT. BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL -NECROSIS,-MINIMAL ADRENAL, CORTEX (AC) : -VACUOLATION, -MINIMAL 246 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 32 ANIMAL NUMBER: C94506 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 322.1 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 12:53 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: KIDNEY (KD), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, MEDULLA (MA) , TESTIS (TE) 247 I ri Covance 6329-224 APPENDIX 6 3M T-6314.2 Individual Animal Pathology Data RANGE-FINDING dietary toxicity study w ith n -methyl PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 33 ANIMAL NUMBER: C94507 SEX: MALE DATE OF DEATH: 07/13/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 07/13/98 10-41 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 3 SACRIFICE STATUS DEATH: 32 STUDY WEEK OF DEATH: 5 PROSECTOR: WENDY CHERRY PATHOLOGIST: HAMP, BRUNER SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 298.0 GRAMS RECORDER: JODI THIEREN WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0676 2.0294 .8627 2.9125 11.2672 .6989 3.2209 .5221 .0224 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0227 % .6810 % .2895 % .9773 % 3.7809 % .2345 % 1.0808 % .1752 % .0075 % ORGAN TO BRAIN WEIGHT RATIO .0333 1.0000 .4251 1.4352 5.5520 .3444 1.5871 .2573 .0110 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) i -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL 248 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 34 ANIMAL NUMBER: C94507 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 298.0 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:41 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 249 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 35 ANIMAL NUMBER: C94508 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 357.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:23 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0567 2.0861 1.1055 3.3758 13.4521 .8250 2.8780 .7962 .0282 .0158 % .5830 % .3090 % .9435 % 3.7597 % .2306 % .8044 % .2225 % .0079 % .0272 1.0000 .5299 1.6182 6.4484 .3955 1.3796 .3817 .0135 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR-TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL 250 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 36 ANIMAL NUMBER: C94508 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 357.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:23 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) ,KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE,STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) ,AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR(MN) , SKIN (SK) , URINARY BLADDER (UB) ,PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), TESTIS (TE) 251 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 37 ANIMAL NUMBER: C94509 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 301.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:52 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0566 2.1850 .9372 3.0753 10.1043 .5576 3.0521 .6354 .0160 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0187 % .7237 % .3104 % 1.0186 % 3.3469 % .1847 % 1.0110 % .2105 % .0053 % ORGAN TO BRAIN WEIGHT RATIO .0259 1.0000 .4289 1.4075 4.6244 .2552 1.3968 .2908 .0073 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -CYST,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL 252 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 38 ANIMAL NUMBER: C94509 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 301.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:52 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP), CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 253 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 39 ANIMAL NUMBER: C94510 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 282.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:36 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0478 2.0063 .7471 2.9461 10.3504 .7116 2.6666 .4856 .0192 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0169 % .7107 % .2646 % 1.0436 % 3.6665 % .2521 % .9446 .1720 % .0068 ORGAN TO BRAIN WEIGHT RATIO .0238 1.0000 .3724 1.4684 5.1589 .3547 1.3291 .2420 .0096 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MINIMAL APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 40 ANIMAL NUMBER: C94510 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 282.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:36 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) ,KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE,STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) ,AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR(MN) , SKIN (SK) , URINARY BLADDER (UB) ,PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 255 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 41 ANIMAL NUMBER: C94511 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 308.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:45 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0530 2.0354 .8228 2.9192 12.4616 .6977 2.6572 .5913 .0111 .0172 % .6598 % .2667 % .9463 % 4.0394 % .2262 % .8613 % .1917 % .0036 % .0260 1.0000 .4042 1.4342 6.1224 .3428 1.3055 .2905 .0055 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -INFLAMMATION, CHRONIC,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -SLIGHT ADRENAL, CORTEX (AC) : -VACUOLATION,-MINIMAL APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 42 ANIMAL NUMBER: C94511 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 308.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:45 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E S T IS (TE ) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE,STERNUM ( S B ) , LUNG ( L U ) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN ) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEA L ( P P ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ), THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PIT U ITA R Y ( P I ) , THYMUS (TH) , SP IN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ), S A L IV GL, MANDIB (SG) , LN, MANDIBULAR(MN) , S K IN (SK) , URINARY BLADDER (UB) , PROSTATE ( P R ), SEMINAL V E SIC L E S (SV ) , EPID ID Y M ID ES (E P ) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , SPLEEN (S P ) , PANCREAS (P A ), LN, MESENTERIC (M S ), ADRENAL, MEDULLA (MA) , T E S T IS (T E ) 257 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 43 ANIMAL NUMBER: C94512 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 365.6 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:44 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST : HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0377 1.9763 .9490 3.1823 13.9926 .7251 3.1206 .5207 .0254 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0103 % .5406 % .2596 % .8704 % 3.8273 % .1983 % .8536 % .1424 % .0069 % ORGAN TO BRAIN WEIGHT RATIO .0191 1.0000 .4802 1.6102 7.0802 .3669 1.5790 .2635 .0129 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY ADRENAL, CORTEX (AC) : -SMALL; RIGHT: 3 X 2 X 1 MM (FOR COMPARISON, LEFT IS 5 X 3 X 2 MM) GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MINIMAL ADRENAL, CORTEX (AC) : >UNREMARKABLE 258 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 44 ANIMAL NUMBER: C94512 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 365.6 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:44 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, MEDULLA (MA) , TESTIS (TE) 259 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 45 ANIMAL NUMBER: C94513 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 330.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:24 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0538 2.2273 .8336 3.5906 13.3383 .6600 2.9338 .5986 .0216 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0163 % .6735 % .2521 % 1.0858 % 4.0334 % .1996 % .8871 % .1810 % .0065 % ORGAN TO BRAIN WEIGHT RATIO .0242 1.0000 .3743 1.6121 5.9886 .2963 1.3172 .2688 .0097 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (L I ) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MINIMAL 260 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 46 ANIMAL NUMBER: C94513 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 330.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:24 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 261 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 47 ANIMAL NUMBER: C94514 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 349.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:22 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0630 2.3348 .9083 3.6837 13.7000 .8910 3.1234 .6808 .0304 .0180 % .6675 % .2597 % 1.0531 % 3.9165 % .2547 % .8929 % .1946 % .0087 % .0270 1.0000 .3890 1.5777 5.8677 .3816 1.3378 .2916 .0130 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE, -SLIGHT -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MINIMAL 262 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 48 ANIMAL NUMBER: C94514 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 349.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:22 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE,STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), LN, POPLITEAL (PP), CECUM (CE), COLON (CO), RECTUM (RE), THYROID (TY), PARATHYROID (PT), AORTA (AO), PITUITARY (PI), THYMUS (TH), SPINAL CORD (SC), HARDERIAN GLAND (HG) ,AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 263 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE 49 ANIMAL NUMBER: C94515 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 331.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:25 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0545 2.1887 .8303 3.4080 17.4565 .6778 3.0282 .7223 .0252 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0164 % .6596 % .2502 % 1.0271 % 5.2612 % .2043 .9127 % .2177 % .0076 % ORGAN TO BRAIN WEIGHT RATIO .0249 1.0000 .3794 1.5571 7.9757 .3097 1.3836 .3300 .0115 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-SLIGHT -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATE -NECROSIS, -MINIMAL 264 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 50 ANIMAL NUMBER: C94515 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 331.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:25 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY), BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE,STERNUM (SB) , LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), LN, POPLITEAL (PP), CECUM (CE), COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY), KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 265 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 51 ANIMAL NUMBER: C94516 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 295.2 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:27 PROSECTOR: TERRI L. WILLIAMS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0456 2.0552 .7772 3.1619 16.0421 .7592 3.0667 .7229 .0201 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0154 % .6962 % .2633 % 1.0711 % 5.4343 % .2572 % 1.0389 % .2449 % .0068 % ORGAN TO BRAIN WEIGHT RATIO .0222 1.0000 .3782 1.5385 7.8056 .3694 1.4922 .3517 .0098 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATE APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 52 ANIMAL NUMBER: C94516 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 295.2 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:27 PROSECTOR: TERRI L. WILLIAMS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 267 fr Covance 6329-224 3M T-6314.2 APPENDIX 6 Individual Animal Pathology Data 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 53 ANIMAL NUMBER: C94517 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 337.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 12:57 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0725 1.9646 1.1014 3.6453 15.5417 .6331 3.1028 .5009 .0207 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0215 % .5814 % .3260 % 1.0788 % 4.5995 % .1874 % .9183 % .1482 % .0061 % ORGAN TO BRAIN WEIGHT RATIO .0369 1.0000 .5606 1.8555 7.9109 .3223 1.5794 .2550 .0105 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (L I) : -INFLAMMATION, SUBACUTE, -MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -VACUOLATION, HEPATOCELLULAR, -MINIMAL 268 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 54 ANIMAL NUMBER: C94517 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 337.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 12:57 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY), BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), TESTIS (TE), BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY), PARATHYROID (PT), AORTA (AO), PITUITARY (PI), THYMUS (TH), SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 269 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE- 55 ANIMAL NUMBER: C94518 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 316.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:19 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0549 2.0189 .7763 3.1469 19.5437 .7817 2.7821 .7942 .0203 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0173 % .6375 % .2451 % .9937 % 6.1710 % .2468 % .8785 % .2508 % .0064 % ORGAN TO BRAIN WEIGHT RATIO .0272 1.0000 .3845 1.5587 9.6804 .3872 1.3780 .3934 .0101 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL KIDNEY <KD) : -DEGENERATION, TUBULAR,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATELY SEVERE -VACUOLATION, HEPATOCELLULAR, -MINIMAL 270 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 56 ANIMAL NUMBER: C94518 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 316.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:19 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV ER ( L I ) , SPLEEN ( S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E S T IS (T E ) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG ( L U ) , TRACHEA ( T R ) , ESOPHAGUS ( E S ) , HEART ( H T ), MUSCLE, SKELETAL (S M ), NERVE, S C IA T IC ( S N ) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEA L (P P ) , CECUM (C E ) , COLON (C O ), RECTUM ( R E ) , THYROID (TY ) , PARATHYROID (P T ) , AORTA (A O ), P IT U ITA R Y ( P I ) , THYMUS (TH ) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ), SA LIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SK IN (SK ) , URINARY BLADDER (UB) , PROSTATE ( P R ) , SEMINAL V E SIC L E S (SV) , EPIDIDYM IDES (E P ) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , SPLEEN (S P ) , PANCREAS ( P A ), LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , TESTIS (TE) 271 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 57 ANIMAL NUMBER: C94519 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 317.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:16 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/ PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0522 2.1524 .7815 3.0339 14.5708 .7127 2.8462 .5508 .0172 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0164 % .6781 % .2462 % .9559 % 4.5907 % .2245 % .8967 % .1735 % .0054 % ORGAN TO BRAIN WEIGHT RATIO .0243 1.0000 .3631 1.4095 6.7696 .3311 1.3223 .2559 .0080 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (L I) : - INFLAMMATION, SUBACUTE, -MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATE 272 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 58 ANIMAL NUMBER: C94519 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 317.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:16 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP), CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 273 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE- 59 ANIMAL NUMBER: C94520 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 325.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:50 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0485 2.1764 .8017 3.3572 17.1128 .4740 3.0040 .6690 .0278 ORGAN WEIGHT RELATIVE TO BODY WEIGHT {%) .0149 % .6688 % .2464 % 1.0317 % 5.2590 % .1457 % .9232 % .2056 % .0085 % ORGAN TO BRAIN WEIGHT RATIO .0223 1.0000 .3684 1.5425 7.8629 .2178 1.3803 .3074 .0128 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATELY SEVERE PANCREAS (PA) : -INFLAMMATION, CHRONIC,-SLIGHT -HEMORRHAGE, -MINIMAL APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL {N-MEFOSE, T-6314) IN RATS PAGE: 60 ANIMAL NUMBER: C94520 SEX: MALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 325.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:50 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV ER ( L I ) , SPLEEN ( S P ) , PANCREAS ( P A ) , LN , MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E S T IS (T E ) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG ( L U ) , TRACHEA ( T R ) , ESOPHAGUS ( E S ) , HEART ( H T ) , MUSCLE, SKELETAL (S M ), NERVE, S C IA T IC ( S N ) , STOMACH, GL (S T ) , STOMACH, NONGL ( S U ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, POPLITEAL ( P P ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ) , THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), P IT U ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ) , SA LIV GL, MANDIB (SG ) , LN, MANDIBULAR (MN) , SK IN (SK ) , URINARY BLADDER ( U B ) , PROSTATE ( P R ) , SEMINAL V E SIC L E S ( S V ) , E PID ID Y M ID ES (E P ) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT M ICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (S P ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E S T IS (TE) 275 APPENDIX 6 Covance 6329-224 3M T-6314.2 Individual Animal Pathology Data * 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER: C94521 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH- 5 TERMINAL BODY WEIGHT: 226.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:03 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN tjRljAN WAMIS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (Li) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/ PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0436 1.8883 .6830 2.3557 20.2477 .6046 3.1040 .6047 .0149 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0193 % .8344 % .3018 % 1.0410 % 8.9473 % .2672 % 1.3716 % .2672 % .0066 % ORGAN TO BRAIN WEIGHT RATIO .0231 1.0000 .3617 1.2475 10.7227 .3202 1.6438 .3202 .0079 ORGAN S T A 'r u s WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY O B S E R V A T I C) N S HISTOPATHOLOGY LIVER (LI) : -LARGE; ALL LOBES: THICKENED STOMACH, GL (ST) : -RED FOCUS(I)/AREA(S); MUCOSA: SINGLE FOCUS, 1 MM IN DIAMETER GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -ANIMAL THIN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATELY SEVERE LN, MESENTERIC (MS) : -HEMORRHAGE, -MINIMAL STOMACH, GL (ST) : UNREMARKABLE 276 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 62 ANIMAL NUMBER: C94521 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 226.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:03 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , SPLEEN (S P ) , PANCREAS (PA ) , LN, MESENTERIC (MS) , ADRENAL, CORTEX (AC) , ADRENAL, MEDULLA (MA) , T E S T IS (T E ) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN) , STOMACH, NONGL (SU ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, POPLITEAL (P P ) , CECUM (C E ) , COLON (C O ), RECTUM ( R E ) , THYROID (TY) , PARATHYROID (PT ) , AORTA (A O ), PIT U ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , S A L IV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , S K IN (SK) , URINARY BLADDER (UB) , PROSTATE ( P R ) , SEMINAL V E SIC L E S (SV ) , EPID ID Y M ID ES (E P ) (SB ), THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (S P ) , PANCREAS ( P A ) , ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , T E S T IS (T E ) 277 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE- 63 ANIMAL NUMBER: C94522 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 243.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:17 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0735 1.9366 .7866 2.8945 19.4615 .5137 3.2106 .4000 .0172 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0301 % .7940 % .3225 % 1.1868 % 7.9793 % .2106 % 1.3164 % .1640 % .0071 % ORGAN TO BRAIN WEIGHT RATIO .0380 1.0000 .4062 1.4946 10.0493 .2653 1.6579 .2065 .0089 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS H I STOPATHOLOGY LIVER (L I) : -LARGE; ALL LOBES, THICKENED -LIGHT FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE TAN AREAS, UP TO 3 X 4 MM; COLLECTED ON ROUTINE SECTION -DIFFUSELY DARK; ALL LOBES: BROWN LN, MANDIBULAR (MN) : -MOTTLED; BILATERAL: RED AND TAN GENERAL COMMENT (GC) : -MALOCCLUSION; BILATERAL UPPER INCISORS -BONE MARROW SMEAR TAKEN -DISCHARGE-OCULAR; BILATERAL: DARK RED AND DRY BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (L I) : -HYPERTROPHY, HEPATOCELLULAR, -N E C R O S IS , -MODERATE CENTRILOBULAR, -SEVERE LN, MANDIBULAR (MN) : TISSUE MISSING NOTE: MANDIBULAR LYMPH NODE MISSING IN RETRIM. APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 64 ANIMAL NUMBER: C94522 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 243.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:17 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 279 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 65 ANIMAL NUMBER: C94523 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS: UNSCHEDULED (D) DATE OF DEATH: 07/06/98 STUDY DAY OF DEATH: 25 STUDY WEEK OF DEATH: 4 TERMINAL BODY WEIGHT: NOT ENTERED DATE AND TIME OF NECROPSY: 07/06/98 12:17 PROSECTOR: TODD ACKER RECORDER: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: NOT AVAILABLE *** ORGAN WEIGHTS WERE NOT RECORDED *** NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -MALOCCLUSION; BILATERAL, UPPER INCISORS -DISCHARGE-NASAL; DARK RED AND DRY MATERIAL BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SEVERE -NECROSIS,-MODERATELY SEVERE THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), LN, POPLITEAL (PP), CECUM (CE), COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 280 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 66 ANIMAL NUMBER: C94524 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 211.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:57 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0573 1.9767 .6364 2.4286 18.0054 .6151 2.4897 .3243 .0191 .0271 % .9333 % .3005 % 1.1466 % 8.5011 % .2904 % 1.1755 % .1531 % .0090 % .0290 1.0000 .3220 1.2286 9.1088 .3112 1.2595 .1641 .0097 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN .WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY SEMINAL VESICLES (SV) : -SMALL; BILATERAL: EACH IS 7 X 4 X 1 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -SEVERE -NECROSIS, -MODERATE SEMINAL VESICLES (SV) : -SECRETION, DECREASED,-MODERATE 281 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 67 ANIMAL NUMBER: C94524 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 211.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:57 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 282 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 68 ANIMAL NUMBER: C94525 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 228.0 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 12:54 PROSECTOR: TERRI L. WILLIAMS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0507 2.1492 .7775 2.5308 19.5937 .6822 3.1146 .4146 .0303 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0222 % .9426 % .3410 % 1.1100 % 8.5937 % .2992 % 1.3661 % .1818 % .0133 % ORGAN TO BRAIN WEIGHT RATIO .0236 1.0000 .3618 1.1776 9.1167 .3174 1.4492 .1929 .0141 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY ADRENAL, CORTEX (AC) : -DIFFUSELY RED; BILATERAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATELY SEVERE ADRENAL, CORTEX (AC) : >UNREMARKABLE 283 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 69 ANIMAL NUMBER: C94525 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 228.0 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 12:54 PROSECTOR: TERRI L. WILLIAMS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY), BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, MEDULLA (MA) , TESTIS (TE), BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY), KIDNEY (KD), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, MEDULLA (MA), TESTIS (TE) 284 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 70 ANIMAL NUMBER: C94526 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 229.1 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:24 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) EPIDIDYMIDES (EP) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0596 2.0535 .7748 2.7529 20.7386 .4943 3.0650 .5015 .0172 .0260 % .8963 % .3382 % 1.2016 % 9.0522 % .2158 % 1.3378 % .2189 % .0075 % .0290 1.0000 .3773 1.3406 10.0991 .2407 1.4926 .2442 .0084 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY STOMACH, GL (ST) : -DARK FOCUS (I)/AREA (S) ; MUCOSA: TWO DARK BROWN AREAS, EACH IS 2 X 1 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATELY SEVERE STOMACH, GL (ST) : -EROSION,-SLIGHT 285 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 71 ANIMAL NUMBER: C94526 SEX: MALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 229.1 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:24 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , TESTIS (TE) 286 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 72 ANIMAL NUMBER: C94527 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 213.0 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:48 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0715 2.0013 2.0130 7.4326 .1162 .5561 .4566 .0155 .0336 % .9396 % .9451 % 3.4895 % .0546 % .2611 % .2144 % .0073 % .0357 1.0000 1.0058 3.7139 .0581 .2779 .2282 .0077 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY UTERUS (UT) : -LUMEN FILLED WITH'FLUID; BILATERAL: CLEAR FLUID GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL UTERUS (UT) : -DILATATION,-SLIGHT 287 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE 73 ANIMAL NUMBER: C94527 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 213.0 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:48 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 288 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 74 ANIMAL NUMBER: C94528 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 210.0 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:53 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE (GRAMS) TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0706 1.9160 1.9295 7.8862 .0945 .3804 .6013 .0141 .0336 % .9124 % .9188 % 3.7553 % .0450 % .1811 % .2863 % .0067 % .0368 1.0000 1.0070 4.1160 .0493 .1985 .3138 .0074 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -VACUOLATION, HEPATOCELLULAR,-MINIMAL 289 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 75 ANIMAL NUMBER: C94528 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 210.0 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:53 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC) ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY), PARATHYROID (PT), AORTA (AO), PITUITARY (PI), THYMUS (TH), SPINAL CORD (SC), HARDERIAN GLAND (HG),AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG), LN, MANDIBULAR (MN), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX(AC), ADRENAL, MEDULLA (MA), 290 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 76 ANIMAL NUMBER: C94529 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 228.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:27 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .1022 1.9228 2.6260 8.7876 .1418 .6896 .6188 .0177 .0447 % .8404 % 1.1477 % 3.8407 % .0620 % .3014 % .2705 % .0077 % .0532 1.0000 1.3657 4.5702 .0737 .3586 .3218 .0092 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, -MINIMAL 291 m APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 77 ANIMAL NUMBER: C94529 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: j32 aSxTuUDu Yi WncEiCEiAK. uOFr uDjEuATH: 5 TERMINAL BODY WEIGHT: 228.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:27 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), LN, POPLITEAL (PP), CECUM (CE), COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), CERVIX (CV), UTERUS (UT), VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 292 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 78 ANIMAL NUMBER: C94530 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 235.2 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:13 PROSECTOR: TERRI L. WILLIAMS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0605 2.0288 2.1802 8.2680 .1644 .5085 .5445 .0133 .0257 % .8626 % .9270 % 3.5153 % .0699 % .2162 % .2315 % .0057 % .0298 1.0000 1.0746 4.0753 .0810 .2506 .2684 .0066 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -VACUOLATION, HEPATOCELLULAR, -MINIMAL 293  Covance 6329-224 3M T-6314.2 APPENDIX 6 Individual Animal Pathology Data 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 79 ANIMAL NUMBER: C94530 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 235.2 GRAMS DATE AND TIME QF NECROPSY: 07/13/98 11:13 PROSECTOR: TERRI L. WILLIAMS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY), PARATHYROID (PT), AORTA (AO), PITUITARY (PI), THYMUS (TH), SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE. FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 294 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 80 ANIMAL NUMBER: C94531 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 207.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:43 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0655 1.9550 2.0538 7.5010 .1314 .4679 .5398 .0173 .0315 % .9408 % .9884 % 3.6097 % .0632 % .2252 % .2598 % .0083 % .0335 1.0000 1.0505 3.8368 .0672 .2393 .2761 .0088 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN GENERAL INFORMATION (XX) : >NOTE :>ANIMAL IDENTIFICATION TRANSPONDER DAMAGED AT NECROPSY BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -VACUOLATION, HEPATOCELLULAR,-MINIMAL 295 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 81 ANIMAL NUMBER: C94531 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 207.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:43 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 82 ANIMAL NUMBER: C94532 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 184.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:04 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE (GRAMS) TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0682 1.9062 1.7582 6.6326 .1150 .4453 .5121 .0175 .0369 % 1.0321 % .9519 % 3.5910 % .0623 % .2411 % .2773 % .0095 % .0358 1.0000 .9224 3.4795 .0603 .2336 .2686 .0092 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -CYST,-MINIMAL 297 m Covance 6329-224 3M T-6314.2 APPENDIX 6 Individual Animal Pathology Data 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 83 ANIMAL NUMBER: C94532 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 184.7 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:04 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) . STOMACH, GL (ST) , STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY), PARATHYROID (PT), AORTA (AO), PITUITARY (PI), THYMUS (TH), SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 84 ANIMAL NUMBER: C94533 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 200.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:52 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0639 2.0393 1.9056 8.3329 .1402 .5051 .4569 .0197 .0319 % 1.0181 % .9514 % 4.1602 % .0700 % .2522 % .2281 % .0098 % .0313 1.0000 .9344 4.0862 .0687 .2477 .2240 .0097 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -VACUOLATION, HEPATOCELLULAR,-MINIMAL 299 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 85 ANIMAL NUMBER: C94533 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 200.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:52 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY), PARATHYROID (PT), AORTA (AO), PITUITARY (PI), THYMUS (TH), SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 300 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 86 ANIMAL NUMBER: C94534 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 197.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:50 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0655 2.0617 1.9166 7.1556 .1380 .4487 .3874 .0217 .0332 % 1.0439 % .9704 % 3.6231 % .0699 % .2272 % .1962 % .0110 % .0318 1.0000 .9296 3.4707 .0669 .2176 .1879 .0105 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -DEGENERATION, TUBULAR,-MINIMAL LIVER (LI) : -VACUOLATION, HEPATOCELLULAR, -MINIMAL LN, MESENTERIC (MS) : TISSUE MISSING NOTE :MESENTERIC LYMPH NODE MISSING IN RETRIM. 301 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 87 ANIMAL NUMBER: C94534 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 197.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:50 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , SPLEEN (SP) , PANCREAS (PA), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 302 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 88 ANIMAL NUMBER: C94535 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 217.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:18 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/ PARATHYR (TT ) .0683 2.0698 1.8145 7.8013 .1276 .5174 .4819 .0196 .0314 % .9525 % .8350 % 3.5901 % .0587 % .2381 % .2218 % .0090 % .0330 1.0000 .8767 3.7691 .0616 .2500 .2328 .0095 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -VACUOLATION, HEPATOCELLULAR,-MINIMAL 303 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 89 ANIMAL NUMBER: C94535 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 217.3 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:18 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY), BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), LN, POPLITEAL (PP), CECUM (CE), COLON (CO), RECTUM (RE), THYROID (TY), PARATHYROID (PT), AORTA (AO), PITUITARY (PI), THYMUS (TH), SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY), KIDNEY (KD), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC(MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), OVARY (OV) 304 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 90 ANIMAL NUMBER: C94536 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 204.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:26 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT' (%) ORGAN TO BRAIN WEIGHT RATIO O R GAN S T A 1' U S ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/ PARATHYR (TT) .0803 1.8203 2.0013 6.8621 .1446 .6338 .5764 .0140 .0393 % .8906 % .9791 % 3.3572 % .0707 % .3101 % .2820 % .0068 % .0441 1.0000 1.0994 3.7698 .0794 .3482 .3167 .0077 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY O B S E R V A T I C )N S HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL 305 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 91 ANIMAL NUMBER: C94536 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 204.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:26 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), OVARY (OV) 306 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 92 ANIMAL NUMBER: C94537 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 223.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:03 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0733 2.0384 2.2858 8.2008 .1269 .4833 .5223 .0192 .0328 % .9124 % 1.0232 % 3.6709 % .0568 % .2163 % .2338 % .0086 % .0360 1.0000 1.1214 4.0232 .0623 .2371 .2562 .0094 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS. HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL KIDNEY (KD) : -PYELITIS,-SLIGHT LIVER (LI) : -VACUOLATION, HEPATOCELLULAR,-MINIMAL 307 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 93 ANIMAL NUMBER: C94537 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 223.4 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:03 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU) , JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO) , RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 308 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 94 ANIMAL NUMBER: C94538 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 192.6 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:25 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0606 1.8703 1.8873 6.9707 .1094 .4307 .7123 .0143 .0315 % .9711 % .9799 % 3.6193 % .0568 % .2236 % .3698 % .0074 % .0324 1.0000 1.0091 3.7270 .0585 .2303 .3808 .0076 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY KIDNEY (KD) : -LARGE PELVIS(ES);' LEFT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL KIDNEY (KD) : -DILATATION, PELVIC,-MODERATE LIVER (LI) : -VACUOLATION, HEPATOCELLULAR,-MINIMAL 309 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE- 95 ANIMAL NUMBER: C94538 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 192.6 GRAMS DATE AND TIME OF NECROPSY 07/13/98 13:25 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU) , JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO) RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 96 ANIMAL NUMBER: C94539 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 217.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:30 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .1090 2.0113 2.6878 8.3813 .1454 .5526 .4936 .0066 .0500 % .9235 % 1.2341 % 3.8482 % .0668 % .2537 % .2266 % .0030 % .0542 1.0000 1.3363 4.1671 .0723 .2747 .2454 .0033 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN EXCLUDE NECROPSY OBSERVATIONS HISTOPATHOLOGY THYROID (TY) : >NOTE :>ONE THYROID/PARATHYROID LOST PRIOR TO WEIGHING GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -PYELITIS,-SLIGHT LIVER (LI) : -VACUOLATION, HEPATOCELLULAR,-MINIMAL THYROID (TY) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL 311 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE 97 ANIMAL NUMBER: C94539 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 217.8 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 11:30 PROSECTOR: WENDY CHERRY RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC) ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST) STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 312 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 98 ANIMAL NUMBER: C94540 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 174.2 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:35 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE (GRAMS) TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0624 1.9367 1.9136 6.6088 .1402 .3929 .3952 .0217 .0358 % 1.1118 % 1.0985 % 3.7938 % .0805 % .2255 % .2269 % .0125 % .0322 1.0000 .9881 3.4124 .0724 .2029 .2041 .0112 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL 313 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 99 ANIMAL NUMBER: C94540 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 174.2 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 8:35 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), OVARY (OV) 314 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 100 ANIMAL NUMBER: C94541 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 234.2 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:06 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE (GRAMS) TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0850 2.0657 2.5187 8.8330 .1394 .6589 .6495 .0164 .0363 % .8820 % 1.0754 % 3.7716 % .0595 % .2813 % .2773 % .0070 % .0411 1.0000 1.2193 4.2760 .0675 .3190 .3144 .0079 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL KIDNEY (KD) : -PYELITIS,-MINIMAL 315 r Covance 6329-224 3M T-6314.2 APPENDIX 6 Individual Animal Pathology Data 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 101 ANIMAL NUMBER: C94541 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 234.2 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:06 PROSECTOR: NANCY DIEDRICH RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY), BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST) , STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) , LN, POPLITEAL (PP), CECUM (CE), COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 316 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 102 ANIMAL NUMBER: C94542 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 242.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:53 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE (GRAMS) TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0880 2.0048 2.5368 9.4944 .1565 .5490 .6078 .0250 .0363 % .8267 % 1.0461 % 3.9152 % .0645 % .2264 % .2506 % .0103 % .0439 1.0000 1.2654 4.7358 .0781 .2738 .3032 .0125 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) ; -VACUOLATION, HEPATOCELLULAR,-MINIMAL 317 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 103 ANIMAL NUMBER: C94542 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 242.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:53 PROSECTOR: MICHELE ZIMA RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 318 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 104 ANIMAL NUMBER: C94543 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 167.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:33 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0487 1.8660 1.7414 6.4505 .0986 .3354 .5563 .0192 .0290 % 1.1114 % 1.0372 % 3.8419 % .0587 % .1998 % .3313 % .0114 % .0261 1.0000 .9332 3.4569 .0528 .1797 .2981 .0103 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY UTERUS (UT) : -LUMEN FILLED WITH FLUID; BILATERAL: CLEAR FLUID GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL UTERUS (UT) : -DILATATION,-MODERATE 319 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 105 ANIMAL NUMBER: C94543 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 167.9 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 13:33 PROSECTOR: JILL PAUS RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY), PARATHYROID (PT), AORTA (AO), PITUITARY (PI), THYMUS (TH), SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 106 ANIMAL NUMBER: C 9 4 5 4 4 SEX: FEMALE DOSE GROUP: 3 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA CR IFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 TERMINAL BODY W EIGHT: 1 8 5 . 5 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 3 : 2 9 PROSECTOR: JAMES T . CALLEN RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/ PARATHYR (TT) .0 5 6 3 2 .0 3 9 5 2 .1 1 5 6 8 .2 2 6 7 .1 4 5 3 .4 6 7 3 .4 8 9 9 .0 1 4 0 .0 3 0 4 1 .0 9 9 5 1 .1405 4 .4 3 4 9 .0 7 8 3 .2 5 1 9 .2 6 4 1 .0 0 7 5 % % % % % % % % .0 2 7 6 1.0000 1 .0373 4 .0337 .0 7 1 2 .2 2 9 1 .2 4 0 2 .0 0 6 9 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : t-NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL 321 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 107 ANIMAL NUMBER: C 9 4 5 4 4 SEX : FEMALE DOSE GROUP: 3 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA CR IFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 8 5 . 5 GRAMS DATE AND TIM E OF NECROPSY: 0 7 / 1 3 / 9 8 1 3 : 2 9 PROSECTOR: JAMES T . CALLEN RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN ) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, POPLITEAL (P P ) , CECUM (CE) , COLON (C O ), RECTUM ( R E ) , THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PITU ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (A S) , SA LIV GL, MANDIB (SG ) , LN, MANDIBULAR (MN) , SK IN (SK ) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , LIV ER ( L I ) , SPLEEN (SP ) , PANCREAS (P A ), LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) 322 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 108 ANIMAL NUMBER: C 9 4 5 4 5 SE X : FEMALE DOSE GROUP: 4 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 8 7 . 2 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 3 : 4 3 PROSECTOR: MICHELE ZIMA RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0 5 8 5 1 .8832 2 .0151 7 .1 7 2 5 .1 2 2 8 .4 6 4 0 .4 7 1 2 .0 1 3 1 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0 3 1 3 1 .0060 1 .0764 3 .8 3 1 5 .0 6 5 6 .2 4 7 9 .2 5 1 7 .0 0 7 0 % % % % % % % ORGAN TO BRAIN WEIGHT RATIO .0 3 1 1 1 .0 0 0 0 1 .0 7 0 0 3 .8 0 8 7 .0 6 5 2 .2 4 6 4 .2 5 0 2 .0 0 7 0 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -PYELITIS,-M ODERATE 323 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 109 ANIMAL NUMBER: C 9 4 5 4 5 SEX: FEMALE DOSE GROUP: 4 SA CR IFICE STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 8 7 . 2 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 3 : 4 3 PROSECTOR: MICHELE ZIMA RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ), LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG (LU ) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN ) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, POPLITEAL ( P P ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ) , THYROID ( T Y ) , PARATHYROID ( P T ) , AORTA (A O ), P IT U ITA R Y ( P I ) , THYMUS ( T H ) , SPINA L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SA LIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SK IN (SK ) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , LIVER ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (AC) ADRENAL, MEDULLA (MA) , OVARY (OV) 324 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-VJEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 110 ANIMAL NUMBER: C 9 4 5 4 6 SEX : FEMALE DOSE GROUP: 4 SA C R IFIC E STATUS: SCHEDULED. TERMINAL SA CR IFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 2 1 9 . 7 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 3 : 4 8 PROSECTOR: DONIA MEYER RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP ) THYMUS (TH ) THYROID/PARATHYR (TT) .0 6 3 4 2 .0 4 9 3 2 .1 3 3 2 9 .5 7 6 8 .1 0 0 6 .5 8 3 0 .6 4 2 7 .0 2 9 3 .0 2 8 9 .9 3 2 8 .9 7 1 0 4 .3590 .0 4 5 8 .2 6 5 4 .2 9 2 5 .0 1 3 3 % % % % % % % % .0 3 0 9 1 .0 0 0 0 1 .0 4 0 9 4 .6 7 3 2 .0 4 9 1 .2 8 4 5 .3 1 3 6 .0 1 4 3 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -V A C U O L A T IO N .-M IN IM A L LIVER (L I) : -VACUOLATION, HEPATOCELLULAR,-MINIMAL 325 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 111 ANIMAL NUMBER: C 9 4 5 4 6 SEX: FEMALE DOSE GROUP: 4 SA C R IFIC E STATUS DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 3 : 4 8 PROSECTOR: DONIA MEYER P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER SCHEDULED, TERMINAL SA CR IFICE TERMINAL BODY WEIGHT: 2 1 9 . 7 GRAMS RECORDER: JO D I THIEREN WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM (SB) LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN ) , STOMACH, GL (ST ) STOMACH, NONGL ( S U ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEA L ( P P ) , CECUM ( C E ) , COLON (CO) RECTUM ( R E ), THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PITU ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ), SA LIV GL, MANDIB (SG ) , LN, MANDIBULAR (MN) , SK IN (SK ) , MAMMARY, FEMALE (M F ), URINARY BLADDER (U B ), CERVIX ( C V ), UTERUS ( U T ) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE ( E Y ) , KIDNEY (K D ), SPLEEN ( S P ) , PANCREAS ( P A ) , LN, MESENTERIC (MS) OVARY (OV) ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , 326 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 112 ANIMAL NUMBER: C 9 4 5 4 7 SEX: FEMALE DOSE GROUP: 4 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 2 3 7 . 1 GRAMS DATE AND TIM E OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 1 9 PROSECTOR: NANCY DIEDRICH RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 7 9 4 2 .1 4 9 9 2 .2 5 8 7 9 .8 3 9 2 .1 3 3 8 .5 5 8 8 .5 9 8 7 .0 1 2 9 .0 3 3 5 .9 0 6 7 .9 5 2 6 4 .1 4 9 8 .0 5 6 4 .2 3 5 7 .2 5 2 5 .0 0 5 4 % % % % % % % % .0 3 6 9 1 .0 0 0 0 1 .0 5 0 6 4 .5 7 6 6 .0 6 2 2 .2 5 9 9 .2 7 8 5 .0 0 6 0 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -DILATATION, PEL V IC ,-SL IG H T 327 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 113 ANIMAL NUMBER: C 9 4 5 4 7 SEX- FEMALE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 - 1 9 P O S T -F IX WEIGHER: NOT AVAILABLE DOSE GROUP: 4 SACRIFICE STATUS: DEATH: 32 STUDY WEEK OF DEATH: 5 PROSECTOR: NANCY DIEDRICH PATHOLOGIST: HAMP, BRUNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: SCHEDULED, TERMINAL SA CR IFICE TERMINAL BODY WEIGHT: 2 3 7 . 1 GRAMS RECORDER: JO D I THIEREN WEIGHER: MATTHEW AXTMAN KHUIUM IK E ), THYROID (TY) , PARATHYROID (P T ) A O R T i I a m HARDERIAN GLAND (HG) , AUDITORY S E B G L ( A S ) ' SALIV B Tm iT*iv u n u u m U -E) , UJLUN (CL rl " J ' S T TM 113 (TH) ' SPIN A L CORD ( S C ) , mammary, f e m a l e ( MF ) , u r in a r y b i d d e r I u b ! : C E R v ix G ( ^ r S i ^ f ^ T ) N ' v S B^ ) <MN)' SK IN ( S K ) ' THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE ( E Y ) , LIVER OVARY (OV) (L I), SPLEEN (S P ), PANCREAS (PA ), LN, MESENTERIC (M S ), ADRENAL CORTEX (AC) ADRENAL, MEDULLA (MA) , 328 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 114 ANIMAL NUMBER: C 9 4 5 4 8 SEX: FEMALE DOSE GROUP: 4 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA CR IFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 8 6 . 8 GRAMS DATE AND TIM E OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 2 9 PROSECTOR: JAMES T . CALLEN RECORDER: JO D I THIEREN PO S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 5 3 6 2 .0980 1 .9 0 1 8 6 .8828 .0 9 4 0 .4 0 5 3 .6 2 8 0 .0 1 6 7 .0 2 8 7 1 .1 2 3 1 1 .0 1 8 1 3 .6 8 4 6 .0 5 0 3 .2 1 7 0 .3 3 6 2 .0 0 8 9 % % % % % % % % .0 2 5 5 1 .0000 .9 0 6 5 3 .2 8 0 6 .0 4 4 8 .1 9 3 2 .2 9 9 3 .0 0 8 0 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIO N S -BONE MARROW SMEAR TAKEN KIDNEY (KD) : -INFLAMMATION, CHRONIC,-MINIMAL 329 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 115 ANIMAL NUMBER: C 9 4 5 4 8 SEX : FEMALE DOSE GROUP: 4 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 8 6 . 8 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 2 9 PROSECTOR: JAMES T . CALLEN RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ), LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG ( L U ) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEAL ( P P ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ) , THYROID (TY) , PARATHYROID (PT ) , AORTA (A O ), PITU ITA R Y ( P I ) , THYMUS (TH ) , SP IN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ), SA LIV G L , MANDIB (SG) , LN, MANDIBULAR (MN) , SK IN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , BRAIN (BR) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) 330 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 116 ANIMAL NUMBER: C 9 4 5 4 9 SEX : FEMALE DOSE GROUP: 4 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA CR IFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY W EIGHT: 2 0 7 . 7 GRAMS DATE AND TIM E OF NECROPSY: 0 7 / 1 3 / 9 8 1 1 : 4 7 PROSECTOR: JOHN S . HALFORD RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 6 5 3 2 .0 5 6 9 2 .1 4 3 1 8 .7554 .1 6 3 6 .5 1 4 5 .4 4 3 9 .0 2 2 1 .0 3 1 4 .9 9 0 3 1 .0 3 1 8 4 .2154 .0 7 8 8 .2 4 7 7 .2 1 3 7 .0 1 0 6 % % % % % % % % .0 3 1 7 1 .0 0 0 0 1 .0 4 1 9 4 .2 5 6 6 .0 7 9 5 .2 5 0 1 .2 1 5 8 .0 1 0 7 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (L I) : -NECROSIS,-M INIM AL 331 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4 -WEEK RANGE-FINDING DIETARY T O X IC IT Y STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-M EFOSE, T - 6 3 1 4 ) IN RATS PAGE- 1 1 7 ANIMAL NUMBER: C 9 4 5 4 9 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 1 : 4 7 PROSECTOR: JOHN S . HALFORD P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER SCHEDULED, TERMINAL SA C R IFIC E TERMINAL BODY WEIGHT: 2 0 7 . 7 GRAMS RECORDER: JO D I THIEREN WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (AC) ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG (L U ), TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN ) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, POPLITEAL (P P ) , CECUM (CE) , COLON (C O ), RECTUM ( R E ), THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PITU ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ) , SA LIV G L, MANDIB (SG ) , LN, MANDIBULAR (MN) , SK IN (SK) MAMMARY, FEMALE (M F ), URINARY BLADDER ( U B ), CERVIX ( C V ) , UTERUS ( U T ) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT M ICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (S P ) , PANCREAS (PA ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 118 ANIMAL NUMBER: C 9 4 5 5 0 SEX: FEMALE DOSE GROUP: 4 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 8 7 . 0 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 4 6 PROSECTOR: DONIA MEYER RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 6 3 0 1 .9038 1 .8946 7 .7 0 1 7 .0 9 6 0 .4 3 1 6 .5 0 6 0 .0 1 6 5 .0 3 3 7 1 .0 1 8 1 1 .0 1 3 2 4 .1 1 8 6 .0 5 1 3 .2 3 0 8 .2 7 0 6 .0 0 8 8 % % % % % % % % .0 3 3 1 1.0000 .9 9 5 2 4 .0 4 5 4 .0 5 0 4 .2 2 6 7 .2 6 5 8 .0 0 8 7 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL KIDNEY (KD) : -P Y E L IT IS , -SLIGHT LIVER (L I) : -INFLAMMATION, SUBACUTE,-MINIMAL 333 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TO X IC ITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-M EFOSE, T - 6 3 1 4 ) IN RATS PAGE: 119 ANIMAL NUMBER: C 9 4 5 5 0 SE X : FEMALE DOSE GROUP: 4 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 8 7 . 0 GRAMS DATE AND TIM E OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 4 6 PROSECTOR: DONIA MEYER RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ), LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (S N ) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEAL ( P P ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ) , THYROID ( T Y ) , PARATHYROID ( P T ) , AORTA (A O ), P IT U ITA R Y ( P I ) , THYMUS ( T H ) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ) , SA LIV GL, MANDIB (S G ) , LN , MANDIBULAR (MN) , SK IN (SK ) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , SPLEEN (S P ) , PANCREAS (PA ) , LN , MESENTERIC (MS) , ADRENAL, CORTEX (AC) , ADRENAL, MEDULLA (MA) , OVARY (OV) APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 120 ANIMAL NUMBER: C 9 4 5 5 1 SEX: FEMALE DOSE GROUP: 5 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA CR IFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 7 1 . 1 GRAMS DATE AND TIM E OF NECROPSY: 0 7 / 1 3 / 9 8 1 2 : 5 4 PROSECTOR: WENDY CHERRY RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 6 6 1 1 .8 8 5 5 1 .9 4 1 9 8 .7911 .1 2 8 9 .4 5 1 7 .3 1 6 0 .0 1 2 6 .0 3 8 6 1 .1 0 2 0 1 .1 3 5 0 5 .1 3 8 0 .0 7 5 3 .2 6 4 0 .1 8 4 7 .0 0 7 4 % % % % % % % % .0 3 5 1 1 .0 0 0 0 1 .0 2 9 9 4 .6 6 2 5 .0 6 8 4 .2 3 9 6 .1 6 7 6 .0 0 6 7 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY UTERUS (UT) : -LUMEN FIL L ED WITH FLU ID ; GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BILATERAL: CLEAR FLUID BRAIN (BR) : -V A C U O L A T IO N ,-M IN IM A L LIVER (L I) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -VACUOLATION, HEPATOCELLULAR, -MINIMAL UTERUS (UT) : -D ILATA TION,-SLIGHT 335 APPENDIX 6 individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-M EFOSE, T - 6 3 1 4 ) IN RATS PAGE: 1 21 ANIMAL NUMBER: C 9 4 5 5 1 SEX: FEMALE DOSE GROUP: 5 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA CR IFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 7 1 . 1 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 2 : 5 4 PROSECTOR: WENDY CHERRY RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITE A L ( P P ) , CECUM (C E ) , COLON (C O ), RECTUM ( R E ), THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PITU ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) ,LN, MANDIBULAR (MN) , SK IN (SK ) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (S P ) , PANCREAS ( P A ), LN, MESENTERIC(M S ), ADRENAL,CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 122 ANIMAL NUMBER: C 9 4 5 5 2 SE X : FEMALE DOSE GROUP: 5 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA CR IFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 2 0 1 . 4 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 5 3 PROSECTOR: MICHELE ZIMA RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 6 6 0 2 .0 5 3 1 2 .3 0 7 9 1 0 .2 3 8 2 .1 2 5 5 .4 7 7 2 .3 9 8 8 .0 2 4 4 .0 3 2 8 1 .0194 1 .1 4 5 9 5 .0 8 3 5 .0 6 2 3 .2 3 6 9 .1 9 8 0 .0 1 2 1 % % % % % % % % .03 2 1 1 .0 0 0 0 1 .1 2 4 1 4 .9 8 6 7 .0 6 1 1 .2 3 2 4 .1 9 4 2 .0 1 1 9 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (L I) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT 337 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 123 ANIMAL NUMBER: C 9 4 5 5 2 SEX: FEMALE DOSE GROUP: 5 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 2 0 1 . 4 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 5 3 PROSECTOR: MICHELE ZIMA RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY ) , BRAIN (BR) , KIDNEY (KD) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ), LUNG ( L U ) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN ) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEAL (P P ) , CECUM (CE) , COLON (C O ), RECTUM ( R E ), THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PITU ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ) , SALIV GL, MANDIB (SG ) , LN, MANDIBULAR (MN) , SK IN (SK ) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY ) , KIDNEY (KD) , SPLEEN (S P ) , PANCREAS ( P A ), LN, MESENTERIC (M S ), ADRENAL, CORTEX(A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) 338 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 124 ANIMAL NUMBER: C 9 4 5 5 3 SEX : FEMALE DOSE GROUP: 5 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 2 0 6 . 3 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 2 : 5 8 PROSECTOR: DONIA MEYER RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 6 7 9 2 .0290 2 .2 0 9 1 10.4 9 0 6 .1 0 8 7 .4 5 6 7 .6 0 8 9 .0 2 3 7 .0 3 2 9 .9 8 3 5 1 .0 7 0 8 5.0 8 5 1 .0 5 2 7 .2 2 1 4 .2 9 5 2 .0 1 1 5 % % % % % % % % .0 3 3 5 1 .00 0 0 1 .08 8 8 5 .17 0 3 .0 5 3 6 .2 2 5 1 .3 0 0 1 .0 1 1 7 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) ': -NO MACROSCOPIC LESIO N S -BONE MARROW SMEAR TAKEN LIVER (L I) : -INFLAMMATION, SUBACUTE, -MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE 339 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 125 ANIMAL NUMBER: C 9 4 5 5 3 SEX: FEMALE DOSE GROUP: 5 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 2 0 6 . 3 GRAMS DATE AND TIM E OF NECROPSY: 0 7 / 1 3 / 9 8 1 2 : 5 8 PROSECTOR: DONIA MEYER RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV ER ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG (L U ), TRACHEA ( T R ) , ESOPHAGUS ( E S ) , HEART ( H T ) , MUSCLE, SKELETAL (S M ), NERVE, S C IA T IC ( S N ) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU ) , DUODENUM (DU) , JEJUNUM ( J E ) , ILEUM ( I L ) , LN, POPLITEAL (P P ) , CECUM (CE) , COLON (CO) , RECTUM ( R E ) , THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), P IT U ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (A S ) , S A L IV GL, MANDIB (SG ) , LN, MANDIBULAR (MN) , SK IN (SK ) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , SPLEEN (S P ) , PANCREAS ( P A ), LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (M A ), OVARY (OV) 340 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 126 ANIMAL NUMBER: C 9 4 5 5 4 SEX: FEMALE DOSE GROUP: 5 SA CR IFICE STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 8 4 . 4 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 1 9 PROSECTOR: WENDY CHERRY RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 5 8 2 1 .8946 1 .9 4 0 2 8.6 7 7 8 .0 9 7 2 .3 5 7 5 .3 7 1 1 .0 1 4 9 .0 3 1 6 1 .0 2 7 4 1 .0 5 2 2 4 .7060 .0 5 2 7 .1 9 3 9 .2 0 1 2 .0 0 8 1 % % % % % % % % .0 3 0 7 1 .0 0 0 0 1 .02 4 1 4 .58 0 3 .0 5 1 3 .1 8 8 7 .1 9 5 9 .0 0 7 9 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY UTERUS (UT) : -LUMEN FILLED WITH FLUID; BILATERAL: CLEAR FLUID GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION, -MINIMAL LIVER (LI) : -INFLAMMATION, SUBACUTE,-MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -SLIGHT UTERUS (UT) : -DILATATION,-SLIGHT 341 * APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4 -WEEK RANGE-FINDING DIETARY T O X IC IT Y STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-M EFOSE, T - 6 3 1 4 ) IN RATS PAGE: 127 ANIMAL NUMBER: C 9 4 5 5 4 SEX: FEMALE DOSE GROUP: 5 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA CR IFICE DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 8 4 . 4 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 1 9 PROSECTOR: WENDY CHERRY RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY), KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 342 APPENDIX 6 individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4 -WEEK RANGE-FINDING DIETARY TOXICITY STUDY ^-M ET H Y L p p s f t .TIOROOCTANESULFONAMIDO ETHANOL (N-M EFSE, T - 6 3 1 4 ) IN RATS PAGE: 1 2 8 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E " f" : 0 7 /1 3 /9 8 S S / S S " DEATH: 5 ^ T U dI WEEK OF Df T H : TERMINAL BODY WEIGHT: 1 9 2 . 5 GRAMS RECORDER: JO D I THIEREN " S - M E - O F - C R O P S Y =L O m 3 / 9 8 1 0 : 8 4 'b S " WEIGHER: MATTHEW AXTMAN POST-FIX WEIGHER: NOT ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I ) OVARY (OV) SPLEEN (S P ) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0 6 0 5 2 .0 7 2 5 2 .1 5 9 1 1 0.0252 .1 0 2 8 .4 9 4 4 .8 2 0 4 .0 1 7 7 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0314 % 1.0766 % 1.1216 % 5.2079 % .0534 % .2568 % .4262 % .0092 % ORGAN TO BRAIN WEIGHT RATIO .0 2 9 2 1 .0 0 0 0 1 .0 4 1 8 4 .8 3 7 2 .0 4 9 6 .2 3 8 6 .3 9 5 9 .0 0 8 5 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY BRAIN (BR) : -VACUOLATION, -MINIMAL UTERUS (UT) : -LUMEN FILLED WITH FLUID; BILATERAL: CLEAR FLUID GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN " H y p e r t r o p h y , h e p a t o c e l l u l a r , c e n t r i l o b u l a r ,-mod er a te -VACUOLATION, HEPATOCELLULAR, -MINIMAL UTERUS (UT) : -DILATATION, -MINIMAL 343 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXldlTY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 129 ANIMAL NUMBER: C94555 SEX: FEMALE DOSE GROUP: 5 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 192.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:54 PROSECTOR: JAMES T. CALLEN RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: ___ EYE (EY) BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB , LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS) ADRENAL, CORTEX (AC) , ADRENAL, MEDULLA (MA) , OVARY (OV) APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL T^T.T^Tr7TM3/TMnrn*xTi7cm.FnwAMTno ETHANOL (N-MEFOSE, T-6314) IN R PAGE: 130 if?ANIMAL NUMBER: C94556 ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR -- SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E ?s = r= L ._ .STODY^A^OF DEATH: 32SE ^ S T U D Y WEEK O,,F DT,ErA.T^Hu:. 5 TERMINAL BODY WEIGHT: 206.1 GRAMS RECORDER: JO D I THIEREN WEIGHER: MATTHEW AXTMAN ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO UK A STATUS (TT) .0777 2.0897 2.6036 9.4436 .1349 .6082 .5221 .0150 .0377 % 1.0139 % 1.2633 % 4.5820 % .0655 % .2951 % .2533 % .0073 % 1.0000 1.2459 4.5191 .0646 .2910 .2498 .0072 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY ____ -VACUOLATION,-MINIMAL KIDNEY (KD) : -PYELITIS,-SLIGHT L I -INFLAMMATION, SUBACUTE, -MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, SLIGHT GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN 345 APPENDIX 6 individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER: C94556 SEX: FEMALE DATE OF DEATH: 07/13/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 07/13/98 10:56 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 5 SACRIFICE STATUS: DEATH: 32 STUDY WEEK OF DEATH: 5 PROSECTOR: NANCY DIEDRICH PATHOLOGIST: HAMP, BRUNER SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 206.1 GRAMS RECORDER: JODI THIEREN WEIGHER: MATTHEW AXTMAN STOMACH^ NONGl"*?SU) JE)', ILEUM (IL) , PLITBAL (PP) < C f TM <CE>,- ' RFCTUM (r e ) THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH), SPXNAt CORD (SC), HARDERIAN GLAND (HG) AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY^FEMALE (MF) ! URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING EYE (EY), TISSUES SPLEEN WERE (SP), UPNARNECMRAEARSKAB(LPEA),ATLNM,ICMREOSSECNOTPEIRCICEXA(MMISN),ATIAODNR:ENAL, CORTEX (AC), _ ADRENAL, ___ ITTr. MEDULLA . (MA) OVARY (OV) 346 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 132 ANIMAL NUMBER: C 9 4 5 5 7 SEX: FEMALE DOSE GROUP: 6 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 5 1 . 5 GRAMS DATE AND TIM E OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 0 0 PROSECTOR: JOHN S . HALFORD RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 3 8 1 1.9 4 3 0 1.6 9 7 9 12.4 8 8 7 .0 7 5 8 .3 1 4 3 .3 3 7 6 .0 1 5 2 .0 2 5 1 1 .2825 1 .1 2 0 7 8 .2 4 3 4 .0 5 0 0 .2 0 7 5 .2 2 2 8 .0 1 0 0 % % % % % % % % .0 1 9 6 1 .0 0 0 0 .8 7 3 9 6 .4 2 7 5 .0 3 9 0 .1 6 1 8 .1 7 3 8 .0 0 7 8 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN EYE (EY) : -IN F IL T R A T E , LYMPHOCYTIC,-MINIMAL BRAIN (BR) : -V A C U O L A T IO N ,-M IN IM A L LIVER (L I) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATELY SEVERE LN, MESENTERIC (MS) : TISSUE MISSING NOTE: MESENTERIC LYMPH NODE M ISSIN G I N RETRIM . 347 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 133 ANIMAL NUMBER: C 9 4 5 5 7 SEX: FEMALE DOSE GROUP: 6 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 5 1 . 5 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 1 0 : 0 0 PROSECTOR: JOHN S . HALFORD RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , L IV E R ( L I ) , SPLEEN (S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG ( L U ) , TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC (SN ) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEA L (P P ) , CECUM (C E ) , COLON (C O ), RECTUM ( R E ), THYROID ( T Y ) , PARATHYROID ( P T ) , AORTA (A O ), PIT U IT A R Y ( P I ) , THYMUS ( T H ) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL ( A S ), SA LIV G L, MANDIB (SG) , LN, MANDIBULAR (MN) , SK IN (SK ) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT> , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: KIDNEY (K D ), SPLEEN (S P ) , PANCREAS ( P A ) , ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) 348 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 134 ANIMAL NUMBER: C 9 4 5 5 8 SEX: FEMALE DOSE GROUP: 6 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 5 4 . 4 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 8 : 3 7 PROSECTOR: NANCY DIED R IC H RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (L I) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0 4 5 3 2 .1 1 0 1 1 .7 1 0 6 12.6 8 6 0 .0 7 7 7 .4 3 5 8 .4 2 5 6 .0 1 2 2 .0 2 9 3 1 .3666 1 .1079 8.2 1 6 3 .0 5 0 3 .2 8 2 3 .2 7 5 6 .0 0 7 9 % % % % % % % .02 15 1 .0 0 0 0 .8 1 0 7 6 .0 1 2 0 .0 3 6 8 .2 0 6 5 .2 0 1 7 .0 0 5 8 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : - VACUOLAT I ON, -MINIMAL LIVER (L I) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE 349  APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY T O X IC IT Y STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-M EFOSE, T - 6 3 1 4 ) IN RATS PAGE: 135 ANIMAL NUMBER: C 9 4 5 5 8 SEX: FEMALE DOSE GROUP: 6 SA C R IFIC E STATUS: SCHEDULED, TERMINAL SA C R IFIC E DATE OF DEATH: 0 7 / 1 3 / 9 8 STUDY DAY OF DEATH: 3 2 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 5 4 . 4 GRAMS DATE AND TIME OF NECROPSY: 0 7 / 1 3 / 9 8 8 : 3 7 PROSECTOR: NANCY DIED R IC H RECORDER: JO D I THIEREN P O S T -F IX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: MATTHEW AXTMAN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER ( L I ) , SPLEEN ( S P ) , PANCREAS ( P A ) , LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (F E ) , MARROW, FEMUR (FM) , MARROW, STERNUM (S E ) , BONE, STERNUM ( S B ) , LUNG (L U ), TRACHEA (TR) , ESOPHAGUS (E S ) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, S C IA T IC ( S N ) , STOMACH, GL ( S T ) , STOMACH, NONGL (SU ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , LN, PO PLITEA L (P P ) , CECUM (C E ) , COLON (C O ), RECTUM ( R E ), THYROID (TY) , PARATHYROID (P T ) , AORTA (A O ), PIT U ITA R Y ( P I ) , THYMUS (TH) , SPIN A L CORD ( S C ) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (A S) , S A L IV GL, MANDIB (SG ) , LN, MANDIBULAR (MN) , SK IN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING T IS S U E S WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (S P ) , PANCREAS ( P A ), LN, MESENTERIC (M S ), ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (MA) , OVARY (OV) 350 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 136 ANIMAL NUMBER: C94559 SEX: FEMALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 134.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:17 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0351 1.7981 1.4107 9.8766 .0511 .4295 .4142 .0118 .0261 % 1.3369 % 1.0488 % 7.3432 % .0380 % .3193 % .3080 % .0088 % .0195 1.0000 .7846 5.4928 .0284 .2389 .2304 .0066 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATELY SEVERE 351 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 137 ANIMAL NUMBER: C94559 SEX: FEMALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 134.5 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:17 PROSECTOR: DONIA MEYER RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), LN, POPLITEAL (PP), CECUM (CE), COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 352 APPENDIX 6 individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 138 ANIMAL NUMBER: C94560 SEX: FEMALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 172.6 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:39 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: STEVE VAN ADESTINE ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS)' ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0389 2.0925 1.6771 14.9295 .0671 .5289 .6468 .0095 .0225 % 1.2123 % .9717 % 8.6498 % .0389 % .3064 % .3747 % .0055 % .0186 1.0000 .8015 7.1348 .0321 .2528 .3091 .0045 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN BRAIN (BR) : -VACUOLATION,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATELY SEVERE 353 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE- 139 ANIMAL NUMBER: C94560 SEX: FEMALE DOSE GROUP: 6 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 172.6 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 9:39 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: STEVE VAN ADESTINE THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI), SPLEEN (SP), PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST) , STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) ,LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , KIDNEY (KD) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL ^ DPOPT.nnsnnr-TANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 140 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C94561 nDDAAATTTFEE AnOpFNDDDEETAAIlTMtHEi-.OF0v 7n/N1E3C/R9OP8SY: SEX: FEMALE 07/S1T3U/D9Y8 D1A3Y:3O6F DEATH:PR3O2SSEECTOGRR:0SUTTPEU-RDRYIWEL.EKW,,IOTLFrLTIDTAEAM,,TSoH: 5 TERMINAL BODY WEIGHT: 161.3 GRAMS RECORDER: JODI THIEREN WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/ PARATHYR ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) (TT) NECROPSY .0618 1.9670 1.9650 13.3315 .0797 .4122 .4100 .0182 .0383 % 1.2195 % 1.2182 % 8.2650 % .0494 % .2555 % .2542 % .0113 % OBSERVATIONS ORGAN TO BRAIN WEIGHT RATIO .0314 1.0000 .9990 6.7776 .0405 .2096 .2084 .0093 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN HISTOPATHOLOGY BRAIN (BR) : -VACUOLATION,-MINIMAL SKI AT OPECIA-FOCAL- RIGHT AND LEFT HIP REGIONS: SINGLE AREA ON EACH; LEF? IS 45 X 29 MM, RIGHT IS 42 X 30 MM (CAPS 21 AND 22) GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -ANIMAL THIN ^-HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATELY SEVERE SKIN (SK) : -INVOLUTION, FOLLICULAR,-SLIGHT 355 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL ft.rinROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 141 ANIMAL NUMBER: C94561 SEX: FEMALE DATE OF DEATH: 07/13/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 07/13/98 13:36 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 6 SACRIFICE STATUS: DEATH: 32 PROSECTOR STUDY WEEK OF DEATH: TERRI L. WILLIAMS 5 PATHOLOGIST: HAMP, BRUNER SCHEDULED, 'TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 161.3 RECORDER: JODI THIEREN WEIGHER: LYNN HORNER GRAMS URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE e?EL (EY)G KIDNEY^ (KDk " OVARY (OV) pIn CREASS" I? S T mS S eRIC (MS). ADRENAL, CORTEX (AC). ADRENAL. MEDULLA (MA). __ _________________________________________________ 356 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 142 07/13/98 I S tT of DEATH: " " ^ DATE AND TIME OF ^CROPSY: ^7/13/98 10:52 POST-FIX WEIGHER: ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0589 2.0415 1.8903 10.9656 .1065 .4382 .5178 .0154 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 165.1 GRAMS dY WEEK OF DEATH: 5 RECORDER: JODI THIEREN BRUNER_______ WEIGHER: LYNN HORNER ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0357 % 1.2365 % 1.1449 % 6.6418 % .0645 % .2654 % .3136 % .0093 % ORGAN TO BRAIN WEIGHT RATIO .0289 1.0000 .9259 5.3713 .0522 .2146 .2536 .0075 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY BRAIN (BR) : -VACUOLATION,-MINIMAL KIDNEY (KD) : -PYELITIS,-MINIMAL LI-HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATELY SEVERE GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS -BONE MARROW SMEAR TAKEN 357 APPENDIX 6 Individual Animal Pathology Data Covance 6329-224 3M T-6314.2 4-WEEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE- 143 ANIMAL NUMBER: C94562 SEX: FEMALE DOSE GROUP: 6 SACRIFICE STATUS SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 07/13/98 STUDY DAY OF DEATH: 32 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 165.1 GRAMS DATE AND TIME OF NECROPSY: 07/13/98 10:52 PROSECTOR: JOHN S. HALFORD RECORDER: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: HAMP, BRUNER WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LIVER (LI) , SPLEEN (SP) , PANCREAS (PA) , LN, MESENTERIC (MS) , ADRENAL, CORTEX (AC) ADRENAL, MEDULLA (MA) , OVARY (OV) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST)' STOMACH, NONGL (SU) , DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , LN, POPLITEAL (PP) , CECUM (CE) , COLON (CO), RECTUM (RE), THYROID (TY) , PARATHYROID (PT) , AORTA (AO), PITUITARY (PI), THYMUS (TH) , SPINAL CORD (SC), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SALIV GL, MANDIB (SG) , LN, MANDIBULAR (MN) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , UTERUS (UT) , VAGINA (VA) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: EYE (EY) , SPLEEN (SP) , PANCREAS (PA), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , OVARY (OV) 358 APPENDIX 7 Cell Proliferation Report Covance 6329-224 3M T-6314.2 Note: This appendix o f the report contains information supplied by Pathology Associates International and has been reviewed by the Quality Assurance Unit of Pathology Associates International 359 Covance 6329-224 3M T-6314.2 Cell Proliferation Report Pathology Aaaodataa International A Company o f Science Applications International Corporation FINAL r a i . PROLIFERATION REPORT COVANCE STUDY NUMBER 6329-224 PREPARED FOR: 3M TOXICOLOGY SERVICES BUILDING 220-2E-02,3M CENTER ST. PAUL, MN 55144-1000 PREPARED BY: PATHOLOGY ASSOCIATES INTERNATIONAL 15 WORMAN'S MILL COURT, SUITE I FREDERICK, MD 21701 MAY 12,2006 15 M fll C ^ t , Stte I * Frederick, M^rytand 21701 * (301) 663-1644 * (301) 663-8994 FAX Covance 6329-224 3M T-6314.2 Fiml CeilPraHtostionReport Covaoce Study Number6329-224 Page 2 TABLE OF CONTENTS I. CELL PROLIFERATION REPORT H. TABLES m . SIGNATURE PAGE IV. QUALITY ASSURANCE STATEMENT V. APPENDIX I 361 Covance 6329-224 3M T-6314.2 Final CeilPratiftntion Report Covance StudyNumber 6329-224 Page 3 CELL PROLIFERATION REPORT 4-W EEK RANGE-FINDING DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T-6314) IN RATS COVANCE STUDY NUMBER6329-224 PURPOSE The propone o f tin study was to assess the toxicity of die test material when, administered in the diet to rats for at least 4 weeks. This report, by Pathology Associates International (PAI) to the study Sponsor, 3M, iwpresmrta th e cell proliferation findings and intopretadon for Covance Study Number 6329*224 t M4-Wedc Range Finding Dietary Toxicity Study with N-Methy! Perfloor ooctancaidfbnamido Ethanol (N-MeFOSE, T-6314) In Rats'*. A ll aspects o f the tasks associated w ith PAI's portion o f tins study were conducted in compliance with the Food and Drug A drem tsbatien Good l a boratory Practice (GLP) Regulations as set forth in Title 21 o f the US Code o f Federal Regulations, Part 58, issued December 22, 1978 (effective June 20,1979), MATERIALS AND METHODS Tissue Collect! for Cell Profiferatk Six annuals per sex per gpoup in groape 1 through 6 were sacrificed during week 4 for hqratocelhdar proliferation. A section o f the left lateral lobe o f the liver from each o f 6 rats per sex pro group (geoupsl-6) was fixed and processed to paraffin block by Covance per protocol speeificatioaa. Tissue M ods were shap ed to PAI for sectioning and staining. From cadi block, a slide w as pceproed for H&E evaluation and immuncfoistocheinical detection of proliferating cell nuclear 8ifogai (PCNA), a marker o f cell proliferation. Iaammelristeelicniiati-y for C dl Proliferalien Sections o f paraffin-embedded tisanes w o e cut at S pm and placed on positively charged slides (Superfrost Pins, Fidier Scientific, Pittsburgh, PA) to ensure adhesion during processing for PCNA. Standard immunofaiatodiermcal methods were used to stain tissues for PCNA (PAI's SOP for inamnnolristodiemistry). Briefly, tissue sections were incubated with a monoclonal antibody to PCNA (DAKO, lot #016, PAI N o. AI723) and reagents required for die avidin-biotin peroxidase (ABC Elite Kit, lot #FK.-6100, PAI No. K 324) method for foe detection o f foe antigen-antibody complex. PCNA expression in cells in all phases o f foe cell cycle (G,, S, Gz and M ) w as localized by the chromagen 3,3'-diaminabenzidine (DAB; Sigma Chemical Co., lot #18H8201). Tissue sections were counterstained with hematoxylin. A negative control slide was inrfrulad in foe staining run and consisted of study tissue that was not incubated with the primary antibody. 362 Covance 6329-224 3M T-6314.2 Cefl ProHffcnttm Measurements Final CeQFDoUfoatkReport Covance StadyNumber6329-224 Page 4 For cell proliferation entatm a, slides were fin i penned at low magnification (100X) to judge aita&ty sad edioning, pattern of cell labeling (e.g., csntrilobular o r proliferation, c h as Kupffer cells, bile duct epithelium , S S t h e S a ) . and hiatom ogto le g c changes. CeB proliferation w asthen quantified at higher n u llific a tio n (200X). The percentage o f hpatocytes m S phase o f the cell cycle ta d S T l^ w a s determined by scoring at least 3000 hpatocytes m 10 randomly selected fields per animal. Ffiatmnorphology was fbrfoer assessed by evaluating the serial H&E slide for each am m alevahsatedfor ceB proliferation. S tatistical A nalysis The Student's /-test (two-sided, unequal variance) was used to test for statistical significam m PI between and treatment groups using Microsoft Excel version 5.0. A P value o f 0.05 waajudged to he statistically gjgtkiilfemt. RESULTS Ce&ProH feratkn fodm dual anim al and gpoup mean ceB profiferation date are presented in Section E (Tables l ^and 2). The percentage o f prohferating hepateeytes as determined by the labeling index (LI) did not differ significantly between control and treated groups o f male or female rats. In group 6 there waa no PGNA sBde present for animal C94523; therefore, five out o f six animals w ere reported for this gcmqi. H tetapsthology Sections horn the same tissue blocks used for preparation o f PCNA-stamed slides w ere stained with hem atoxylin and eoara (H&) for histopathologic evaluation to facilitate the interpretation of the unnumostained slides. Individual animal findings and group summaries are presented in Appendix L The results showed no changes in foe liver tissue o f male and female rats that would alter the interpretation o f the PCNA staining in this study. The livers from one mid-high dose and two \o A dose " J rate, and two high d o female rats each contained focal necrosis w ithout a inflammatory response. This necrosis was not accompanied by a secondary regenerative effect as determined by an increased PGNA LX. 363 Covance 6329-224 3M T-6314.2 SUMMARY Ftod CeUPniBfaitiaB Rqpcat Covtnce StudyNumber6329-224 PageS In the present stttdy, ceflproKfeistion we* measured within the liver o f male and female rats from control (0 ppm ), 1aw dose (1 ppm), low-raid doae (10 ppm), mid dose (30 ppm ), m id-high dose (100 ppm ), and high dose (500 ppm) groups after 4 weeks on study. N o statistically significant increases in ceH pecdifeation, as determined by the PCNA labeling index (LI) w ere observed in m ak o r female rats after 4 weeks ofN -m ethyl perfluorooctaneaulfonamido ethanoL 364 Covance 6329-224 3M T-6314.2 Final CellProliferationReport Covance Study Number 6329*224 Page 6 H . TABLES Legend SEM Standard Eiror o f the Mean 365 Covance 6329-224 3M T-6314.2 Covane Study No. 8239-224 Tabto tl-1. Colt Proliferation In Uvar of Mala Rate Alter 4 Weeks ofN-MaPOSE f Ommi0 1 -0 ppm (Control) 2 -1 pom (Low) 3-10 ppm (Lew-Mid) 4-30 ppm (MM) 5 - 100 ppm (Mid-High) 6 - 500 ppm (High) ~nwNx < Anim al L a b elin g S ax ' N um ber Index M i C94491 0.188% M C94482 I 0.138% M : C94493 ! : NP M : C94464 ; 0.186% M ; C9449S M : C94468 I Mean j SEN M I C94497 0.407% 0.158% 0280% 0.048% 0.427% M ! C94498 0.082% M I C94499 0.728% M : C94600 ! 0.170% M I C94601 0.087% M ! C94802 0.518% I M ean - 0330% SEM M CfrlOO M C94504 M C94808 M C9480S M ! C94807 0.110% 0.377% 0328% 0.879% 0.188% 0.084% ST \ C04808 j M ean. i SCM M ! C94S09 M C94S10 M ; C94511 M C94S12 M C94813 M ! C94S14 0.107% 0300% 0.000% 0327% 0.064% 0325% 0329% 0378% 0381% , M ian i 8EM M i C94515 M ; C94516 M ! C94517 M ! C94518 M i C94519 M C94820 0318% 0380% 0380% 0.337% 0383% 0395% 0.384% 0.055% M ean SEM M ! C94521 M C94522 0384% 0.050% 0.166% 0.054% M . C94523 > NP M C94524 j 0.112% M ; C9452S 0.085% M i C94526 0.191% ; Mean 0.127% SEM 0.028% 1 NP; tissue ned present on sHdafor #094493 NP; slide not present for#094523 1 I Page 11-1 Covance 6329-224 3M T-6314.2 Covane Study No. 6230-224 Tabi 11-2. Cett ProllfaraMon In Liver of Fama! Rata Aitar 4 Weeks of N-MeFOSE i PCNA 1 Animal Labaling ______ agony Sax ; Humbar i Indax 1 -0 oom (Control) F 1 C04527 1 ND F C84525 I 0.082% .F C84529 i 0.138% F C84630 0.566% F ! C04631 0.084% F i C84532 0.138% ' Maan 0 .2 0 1 % ; SCM ; o.ooz% 2 -1 oom (Low) F ! C84533 0.135% F I C84534 i 0.138% F ^ C94535 ; 0.111% F : C94536 F i C84537 F : C94538 0.401% 0.347% 0.272% ; Maan 0.234% . SEM i 0.061% 3 - 1D DORI (Law-Mid) F < C94539 0.160% F i C84540 0.054% F i C84541 0.080% F I C84542 0.110% F ^ C94543 0.168% F ; C84544 0.168% i Usait- Q.1 4 - 3 0 oom (MW) ; 8EM F C94545 F C84546 F C84547 F C94548 F CB4548 F' C84550 Maan 0 .0 2 0 % 0.137% 0.110% 0.192% 0.112% 0.161% 0.080% 0.132% SEM 0 .0 1 6 % 5-100 ppm (MM-High) F C84551 0.356% F C94552 0.080% F CB4553 0.062% F C84554 0.081% F ' C94555 0.083% F T C94556 0.055% 6 - 500 ppm (High) ^ Maan ! 0.123% SEM 0.047% F C94557 0.193% F C9455B 0.027% F C94559 0.081% F : C94560 0.193% F * C94561 0.181% F ; C94562 0.142% Mean 4 0.133% - -- --------, 'SE--M------T'T----0--.0--2--7-%---- " i ND: not determined due to insufficient tissue on slide [ Page IK-2 367 Covance 6329-224 3M T-6314.2 Final Cell ProtiforatkmReport Covance StudyNumber6329-224 Page 7 IH. SIGLATURE PAGE Submitted by: Project Manager: Project Pathologist: ^ Carolyn M oyrf, D .V M , Diplomate. A.C.V.P. s -z s -o o D ate D ate / /t cO -- rZ 7 368 Covance 6329-224 3M T-6314.2 Final Cell Prolifexatioii Report Covmce Study Number 6329-224 PageS IV. QUALITY ASSURANCE STATEMENT Pathology Associates International aA on w fu y-o rau1Mucgipf-jpU a-cm**-m-n^iw|n w* wai uj-^, w w.oIi Covance 6329-224 3M T-6314.2 Cell Proliferation Report 4-W eek Range-Finding Dietary Toxicity Study with N-Methyl Perflnoroctaneenlfonaniido Ethanol (N-MeFOSE, T-6314) in Rata Covanee StudyNnanber 6329-224 QUALITY ASSURANCE STATEMENT Tins ceU profficntion project has been inspected and audited by the PAI Quality Aancanee Unk(QAU) as required by die Good Laboratory Practice (GLP) regulations proeadgaed by die U.S. Feed and Drag Administration (FDA). The cell proliferation repeat is m accurateicSeetiait oftherecacdeddata. The followingtable is a record ofthe inepectiau/aadits performedandreportedby die QAU. Date o f Inspection 08/12/98 03/31;04/04/00 03/31;04/04/00 05/12/00 Phase Inspected Date Findings Reported to PAI Msnaggncmt/Proiect Manager Microtomy StudyData and Supporting Docignenlatkm Draft Cell ProferatianReport Final CeB ProliferationReport 08/13/98 04/04/00 04/04/00 05/12/00 - r L - - .tA Karen E. Butler Quality Assurance Officer Date 15 Worman's Mill Court, Suite I Frederick, Maryland 21701 (301) 663-1644 (301) 663-8994 FAX 370 Covance 6329-224 3M T-6314.2 Final Cell Protiftntion Report Covance Study Number 6329-224 Page 9 A P P E N D IX ! 371 Covance 6329-224 3M T-6314.2 Pinal DriftCdl Proftftntxm Report Covance StudyNo. 6329-22* IedKldwd AnimalHbtoaaerpfcofcfkFbuilsgi ta liver: 4-Week I U e |i TlwrllagDietaryTwWty Stady with N-Methyl PerfiMroectneselfoMinHe Etbanol (N-MeFOSE,T-6314) in Rats Animal Nember C94491 C54492 C94493 C94494 C9449S C94496 C94497 C94490 044 04500 04301 04502 04503 04504 04505 04506 04587 045 04509 04510 04511 04512 04513 04514 04515 04516 04317 0451 045 04525 C94521 04522 04523 04524 04525 04526 Sex M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M DoaeGnmp I-Oppm (Control) 1-0ppm (Control) 1-0ppm (Control) 1-0ppm (Control) 1-0ppm (Canted) 1-0ppm (Control) 2-1 ppm (Low) 2-1 ppm (Low) 2-1 ppm (Low) 2-1 ppm (Low) 2*l ppm (Low) 2-1 ppm (Low) 3-10 ppm(Low-nod) 3-10 ppm(Low-raid) 3-10 ppm(Low-ray) 3-10 ppm(Low-arid) 3-10 ppm(Low-mid) 3-10 ppm(Low-raid) 4-30 ppm (Mid) 4-30 ppm(Mid) 436 ppm(Mid) 4-30 ppm(Mid) 4-30 ppm (Mid) 4-30ppm(MM) 5-100ppm(Mid-high) 5-100ppm(Mi&htgh) 5-100 pfan(Mid-high) 5-100 ppm(Mid-high) 5-160ppm(Mid-high) 5-100 ppm(Mid-high) 6-506 ppm(High) 6-500 ppm(High) 6-506 ppm (High) 6-500 ppm(High) 6-500 ppm(High) 6-500 ppm(High) Hbtdbgle Findings No SignificantFindings No Significant Findings No SignificantFindings No Significant Findings No Significant Findings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No Significant.Findings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings Focal Necrosis No Significant Findings No SignificantFindings No SignificantFindings No SignificantFindings Focal Necrosis Focal Necrosis No SignificantFindings No SignificantFindings Covance 6329-224 3M T-6314.2 Final DraftCell PraHfentioa Report Covance Study No. 6329-224 ImUvWm IAnimal Hbteaasrplwiogk Findings in Liver: I TTi 11 TTaagu Tlnillfta ilk f r j Trrlrtty Thirty Trtth TTM rth jl P erflw m rtaaH lftM rtfc Ethanol (N-MeFOSE, T-6314) in Rata AafandNmfatr C94527 C94528 C94529 C94530 C94531 C94S32 C94S33 C94534 CMSS CM536 C94537 C94538 C94S39 C94540 C94541 C94542 C94543 C94544 C94545 C94546 C94547 C94548 C94S49 C94550 C94551 C94552 C94S53 C94S54 C94S55 C94556 C94557 04558 04559 01568 C94561 04562 Sex F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F DoseGnwp 1-0ppm (Control) 1-Oppm (Control) 1-Oppsn (Control) 1-Oppm (Control) 1-Oppm (Control) 1-Oppm (Control) 2-1 ppm (Low) 2-1 ppm 0Low) 2-1 ppm (Low) 2-1 ppm (Low) 2-1 ppm (Low) 2-1 ppm (Law) 3-10 ppm (Low-mid) 3-10 ppm(Low-mid) 3-10ppm (Low-mid) 3-10 ppm(Law-mid) 3-10 ppm(Law-mid) 3-10 ppm(Low-mid) 4-30 ppm(hfid) 4-30 ppm(Mid) 4-30ppm(Mid) 4-30 ppm(Mid) 4-30 ppm(Mid) 4-30 ppm(Mid) S-100 ppm (Mid-high) 5-100 ppm (Mid-high) 5-100 ppm (Mid-high) S-100 ppm(Mid-high) 5-100 ppm(Mid-high) 5-100 ppm(Mid-high) 6-500 ppm(High) 6-500 ppm(High) 6-500 ppm(High) 6-500 ppm(High) 6-500 ppm(High) 6-500 ppm(High) Histologic Findings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings .No SignificantFindings No SignificantFindings No.Sigmficant Findings No Significant Findings No Significant Findings No SignificantFindings No SignificantFindings No Significant Findings: No SignificantFindings No SignificantFindings No Significant Findings No SignificantFindings No SignificantFindings No Significant Findings No SignificantFindings No Significant Findings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No SignificantFindings No Significant Findings No Significant Findings No SignificantFindings Focal Necrosis Focal Necrosis No SignificantFindings No SignificantFindings 373