Document zbjREMbDwLK7j5bZbez6pXLp6

ARjU-03 'Ub N I c o v/h 1> THE DEVELOPMENT SERVICES COMPANY 004546 Draft Report 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats PREPARED FOR: 3M St. Paul, Minnesota COVANCE STUDY NUMBER: 6329-225 004547 THE DEVELOPMENT SERVICES COMPANY Sponsor: 3M St. Paul, Minnesota AUDITED DRAFT May 25, 1999 FINAL REPORT Study Title: 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats A uthor: Peter J. Thomford, PhD Study Completion Date: To be determined Performing Laboratory: Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Laboratory Study Identification: Covance 6329-225 Sponsor Study Identification: Study No. 3M T-6314.1 Page 1 of 551 004548 QUALITY ASSURANCE STATEM ENT Covance 6329-225 3M T-6314.1 004549 2V Covance 6329-225 3MT-6314.1 STUDY IDENTIFICATION 13-Week 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 Monitor Study Location Study Director Study Timetable Study Initiation Date In-Life Start Date In-Life End Date Study Completion Date Marvin T. Case, DVM, PhD 3M Toxicology Services 651.733.5180 Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Peter J. Thomford, PhD Covance Laboratories Inc. P.O. Box 7545 Madison, Wisconsin 53707-7545 608.241.7207 August 27, 1998 September 1, 1998 December 2, 1998 To be determined 004S50 KEY PERSONNEL Covance 6329-225 3M T-6314.1 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 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) Sandra R. Eldridge, PhD Pathology Associates International Johnnie J. Eighmy, DVM, MS Diplomate, ACVP Diplomate, ABT Deborah Pirkel, ALAT 004551 Covance 6329-225 3M T-6314.1 CONTENTS Page ABSTRACT..................................................................................................................................... 8 P U R P O S E ...................................................... 11 REGULATORY COM PLIANCE............................................................................................... 11 TEST M ATERIAL........................................................................................................................ 11 Test M aterial.......................................... 11 Reserve (Archive) Sam ple........................................................................................................ 11 D isposition...................................................................................................................................11 ANIMALS AND H U SBA N DRY ............................................................................................... 12 Test Animal..................................................................................................................................12 Identification............................................................................................................................... 12 A c c lim a tio n ..................................................................................................................................12 Housing and Maintenance......................................................................................................... 12 Justification..................................................................................................................................13 P R O C E D U R E S ............................................................................................................. 13 Group Designations and Dose Levels......................................................................................13 Dose Preparation........................................................................................................................ 14 Retention Samples...................... 15 M ethod of Administration......................................................................................................... 15 Dose Analyses.............................................................................................................................15 Clinical Observations................................................................................................................. 16 Body Weights.............................................................................................................................. 16 Food Consumption.....................................................................................................................16 O p h th a lm o lo g y ............................................................................................................................ 17 Clinical Pathology....................................................................................................................... 17 Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination.................................18 N ecropsy...................................................................................................................................... 18 Organ W eights............................................................................................................................19 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation..................... 19 Palmitoyl-CoA Oxidase Tissue Collection and Analyses......................................................19 Liver PFOS Analyses................................................................................................................. 19 Tissue Preservation.................................................................................................................... 20 Histopathology........................................................................................................................... 20 Statistical Analyses.................................................................................................................... 21 RECORD R E T E N T IO N ............................................................................................................. 21 5 004552 Covance 6329-225 3M T-6314.1 CONTENTS (Continued) Page R ESU LTS....................................................................................................................................... 22 Dose Analyses.............................................................................................................................22 Clinical Observations and Survival.............................. 22 Ophthalmology........................................................................................................................... 23 Body W eights..............................................................................................................................23 Food Consumption.....................................................................................................................23 Test Material Consumption................ 24 Clinical Pathology.......................................................................................................................24 Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination................................ 24 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation..................... 25 Liver PFOS D eterm ination.......................................................................................................25 Anatomic Pathology.................................................................................................................. 25 C O N C L U S IO N S ............................................................................................................................2 6 SIGNATURES............................................................................................................................... 27 R E F E R E N C E S ............................................................................................................. 28 OPHTHALMOLOGY R EPO R T................................................................................................ 29 PATHOLOGY REPORT..............................................................................................................30 COMMENTS ON THE D A T A .................................................................................................. 37 CODES, ABBREVIATIONS, AND UNITS............................................................................ 40 General Codes and Abbreviations........................................................................................... 41 Codes for Clinical Pathology.......................... 42 Abbreviations and Units for Clinical Hematology.................................................................45 Abbreviations and Units for Clinical Chem istry.................................................................... 47 Abbreviations and Units for Clinical Urinalysis..................................................................... 49 Codes for Anatomic Pathology................................................................................................ 50 TABLE 1 Results o f Homogeneity Analyses (ppm)......................................................................... 53 2 Results o f Stability Analyses (ppm).................................................................................. 54 3 Results o f Dose Preparation Analyses (ppm ).................................................................. 57 4 Summary o f Clinical Observations................................................................................... 58 5 Summary o f Ophthalmic Observations....................................................... 60 6 Summary o f Body Weight Data (g).................................................................................. 61 7 Summary o f Body Weight Change Data ( g ) ................................................................... 63 8 Summary o f Food Consumption Data (g)........................................................................65 9 Summary o f Test Material Consumption Data (mg/kg/day).........................................67 T5* 004553 Covance 6329-225 3M T-6314.1 CONTENTS (Continued) Page TABLE (Continued) 10 Summary of Clinical Hematology D ata - W eek 5 ......................................................... 69 11 Summary o f Clinical Hematology D ata - W eek 1 4 .......................................................73 12 Summary o f Clinical Chemistry Data - W eek 5....................................... 77 13 Summary o f Clinical Chemistry Data - W eek 14............................................................ 83 14 Summary o f Clinical Urinalysis D ata................................................................................ 89 15 Summary o f Organ Weight Data - W eek 5 ......................................................................91 16 Summary o f Organ Weight Data - W eek 14................................................................... 93 17 Incidence o f Macroscopic Observations........................................................................ I l l 18 Incidence o f Microscopic Observations......................................................................... 114 19 Incidence o f Severity o f Selected Microscopic O bservations.................................... 123 APPENDIX 1................................................................................................................................126 Protocol Deviations..................................................................................................................127 P rotocol..................................................................................................................................... 129 Protocol Amendment No. 1 ....................................................................................................146 Protocol Amendment No. 2 ....................................................................................................148 Protocol Amendment No. 3 ..................................................................................... 151 APPENDIX 2 ............................................................................................................................... 153 Individual Animal Fate D a ta ...................................................................................................154 Individual Clinical Observations............................................................................................. 159 Individual Ophthalmic Observations...................................................................................... 175 APPENDIX 3 ............................................................................................................................... 191 Individual Body Weight Data (g )...........................................................................................192 APPENDIX 4 ............................................................................................................................... 203 Individual Food Consumption Data (g )................................................................................ 204 Individual Test Material Consumption Data (m g/kg/day).................................................215 APPENDIX 5 ............................................................................................................................... 225 Individual Clinical Hematology Data.....................................................................................226 Individual Clinical Chemistry D ata........................................................................................ 250 Individual Clinical Urinalysis D a ta ........................................................................................ 278 APPENDIX 6 ............................................................................................................................... 290 Individual Anatomic Pathology Data.....................................................................................291 APPENDIX 7 ....................................................................................................... 548 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation...................549 APPENDIX 8 ............................................................................................................................... 550 Client-Supplied Item s..............................................................................................................551 \ 0045S4 Covance 6329-225 3M T-6314.1 ABSTRACT The purpose of this study was to assess the toxicity of the test material, N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) when administered in the diet to rats for at least 13 weeks. Four groups o f Crl:CD*(SD) IGS BR rats were exposed to N-MeFOSE in the diet for at least 13 weeks. Each group contained 20 males and 20 females. The dietary concentrations were 0 (control group), 3, 30, and 100 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 weekly, each animal was removed from its cage and examined for abnormalities and signs o f toxicity. Body weight data were collected on the first day of treatment and weekly thereafter. Food consumption data were collected weekly. Ophthalmic examinations were done before initiation o f treatment and during W eek 14. Blood samples were collected for hematology and clinical chemistry tests during W eeks 5 and 14. Urine samples for urinalysis tests were collected during Week 14. During Weeks 5 and 14, blood was collected from five animals/sex/group for serum perfluorooctane sulfonic acid (PFOS) analyses. At the Week 5 sacrifice, samples o f the liver were collected from five animals/sex/group for palmitoyl-CoA oxidase activity and liver PFOS analysis. Animals sacrificed at Week 5 were not necropsied. During W eek 14, the remaining 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 and liver PFOS analysis. Samples o f the liver were collected from five animals/sex/group for proliferation cell nuclear antigen (PCNA) evaluation and microscopic examination. Microscopic examinations were done on tissues from each animal in the control and high-dose groups (terminal sacrifice only) and from the low-dose animal that was sacrificed at an unscheduled interval. Microscopic examinations were also done on the liver and stomach from each terminal sacrifice animal in the mid-dose group, and on the liver from each terminal sacrifice animal in the low-dose group. 004555 Covance 6329-225 3M T-6314.1 One female given 3 ppm N-MeFOSE was sacrificed on Day 59 due to severe laceration o f the tail. There were no macroscopic or microscopic changes to indicate that its moribund condition was test material-related. 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. Statistically significantly lower mean body weights were noted beginning at Week 4 and continuing through the end o f study for animals given 100 ppm. Statistically significantly lower mean body weights were noted beginning at W eek 7 and continuing through the end of study for males given 30 ppm. Body weight changes were statistically significantly lower in a sporadic manner for animals given 30 o r 100 ppm. Overall body weight changes (Weeks 1-14) were statistically significantly lower for all groups given N-MeFOSE. Although statistically significant only at Week 13, food consumption was in general lower for males given 100 ppm. For females given 100 ppm, statistically lower food consumption was apparent at W eeks 3 ,4 , 6 ,7 ,1 1 , and 12. Dietary administration of N-MeFOSE was associated with lower hematocrit for males and females fed 100 ppm; higher urea nitrogen for males and females fed 100 ppm; higher albumin for males fed 100 ppm; lower globulin for males fed 30 or 100 ppm; lower cholesterol and triglycerides for males fed 30 or 100 ppm and females fed 100 ppm; higher alanine aminotransferase for males fed 100 ppm; and higher hepatic palmitoyl CoA oxidase for males and females fed 100 ppm. The effects were relatively mild with the exception o f those on cholesterol and triglycerides for the high-dose males; those effects were considered to be o f moderate severity. All o f the test material-related clinical pathology findings were more prominent at Week 14 than at Week 5. Statistically significant and test material-related changes in terminal body weights and liver weights were seen in males and/or females in the two highest dose groups. Statistically significant decreases were seen in the terminal body weights o f males fed 30 ppm and in both males and females fed 100 ppm of N-MeFOSE. Statistically significant increases were seen in the mean liver-to-body weight percentage and mean liver-to-brain weight ratio in males fed 30 ppm, in mean absolute liver weight and mean liver-to-body weight percentage in females fed 30 ppm, and in all liver weight parameters in males and females fed 100 ppm. Test material-related macroscopic findings were noted at a low incidence in the liver and glandular stomach o f males and females in the 100 ppm dose group only. Liver findings included organs that were large and diffusely dark. In the glandular stomach, dark foci or 004556 \ areas were sometimes seen in the gastric mucosa. Covance 6329-225 3MT-6314.1 Test material-related microscopic findings were seen in the liver o f animals fed 30 and 100 ppm of N-M eFOSE and in the glandular stomach o f males and females in the 100 ppm group only. No test material-related changes were seen in animals fed 3 ppm o f N-MeFOSE. In the liver, one or more test material-related findings affected all animals fed 100 ppm and included slight-to-moderate centrilobular or diffuse hepatocellular hypertrophy, minimal-to-slight coagulative necrosis, minimal hepatocellular pigment, and minimal-to-slight centrilobular to midzonal or diffuse hepatocellular vacuolation. In animals fed 30 ppm, centrilobular hepatocellular hypertrophy was also seen, although the incidence and severity was decreased at this dose. In addition, a low incidence o f minimal hepatocellular vacuolation occurred in 30 ppm dose group males, and the liver o f a single female fed 30 ppm had minimal coagulative necrosis. A possible test material-related change in the glandular stomach o f animals fed 100 ppm was a relatively low incidence o f mucosal erosions. The erosions were o f minimal to slight severity and involved a very small portion o f the mucosal surface in all cases. Based on the anatomic and clinical pathology results at 30 and 100 ppm and body weight effects at 3, 30, and 100 ppm, the no-observable-adverse-effect level was determined to be less than 3 ppm when N-MeFOSE is administered at concentrations o f 0, 3, 30 and 100 ppm to Crl:CD*(SD) IGS BR rats for at least 13 weeks through dietary administration. 004557 PURPOSE Covane* 6329-225 3M T -6314.1 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 13 weeks. REGULATORY COMPLIANCE All aspects o f this study were in accordance 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 Test M aterial The test material, N-Methyl Perfluorooctanesulfonamido Ethanol (MeFOSE, T-6314), Lot No. To be supplied by Sponsor, is an off white powder. It was received at Covance on August 3, 1995. The test material was stored at room temperature. Information on synthesis methods, stability, purity, composition, or other characteristics that define the test material is on file with the Sponsor. Reserve (Archive) Sample A reserve sample (approximately 5 g) of the test material was taken and stored at room temperature. This sample will be transferred to the Sponsor after authorization from the Sponsor. Disposition Remaining test material will be returned after authorization from the Sponsor. K 004558 ANIMALS AND HUSBANDRY Covance 6329-225 3M T-6314.1 Test Animal Male and female Crl:CD (SD) IGS BR rats were obtained from the Portage, Michigan, facility o f Charles River Laboratories, Inc., on August 17, 1998. The animals were 39 to 45 days old at initiation o f treatment. The males weighed from 184 to 236 g, and the females weighed from 140 to 179 g at initiation o f treatment. Identification Each animal was assigned a temporary number upon arrival. Before initiation o f 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 that number. All data for an animal are recorded under these numbers. Acclimation Ninety-two males and 92 females were received on August 17, 1998, and acclimated in Animal Room 348 for 15 days before initiation o f treatment. In general, animals in this shipment appeared healthy. During acclimation, the animals were examined for abnormalities indicative of health problems, an ophthalmic examination was done, and body weights were recorded for all animals at randomization. Housing and Maintenance Animal Room 348 was used for this study. Environmental controls for the animal room were set to maintain 18 to 26C, a relative humidity o f 30 to 70%, and a 12-hour light/12-hour dark cycle. 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. 004559 Covane* 6329-225 3M T-6314.1 Certified rodent diet #5002 meal, (PMI Nutrition International) was provided (see Protocol Deviations for exceptions) 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 routinely 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 (12 males and 12 females) were removed from the study room and used for training procedures. Justification Historically rats 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 August 27, 1998, and Protocol Amendment Nos. 1 and 2. The protocol, protocol amendments, and protocol deviations are in Appendix 1. Group Designations and Dose Levels The animals were examined by a laboratory animal veterinarian on August 31, 1998, and found to be suitable for study consideration. Selection o f animals for the study was based on clinical observations, body weights, ophthalmic examinations, 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 ^ 004560 Covane* 6329-225 3M T-6314.1 found to be homogeneous. Animals were assigned to the study according to the following design: Number of Animals Dietary Levels Group Male Female (ppm MeFOSE)8 1 (Control)6 20 20 0 2 (Low) 20 20 3 3 (Mid) 20 20 30 4 (High) 20 20 100 a Dose levels were expressed as ppm of MeFOSE. b The control animals received the basal diet only. Dose Preparation Dietary concentrations were based on the test material as supplied. Before initiation o f treatment, diets o f 1, 3, 30, 100, and 500 ppm concentrations were mixed. Diets were prepared for stability analyses at the 1-ppm and 500-ppm concentrations and for homogeneity analyses at the 3, 30, and 100 ppm concentrations. Diets were prepared once every 4 weeks for use in the in-life phase. P rep a ra tio n of D iet fo r G roup 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 of the diet and acetone was then mixed for 15 minutes. P rep aratio n of Diets fo r G roups 2 th ro u g h 3. Each dose level was prepared independently. A specified amount of diet was weighed into a labeled container and a specified amount o f diet for Group 4 was weighed for each diet. A trench was formed in the feed in the mixing bowl and the amount o f diet for Group 4 was transferred to the trench. The contents of the mixing bowl were thoroughly mixed for 15 minutes. P rep a ra tio n of Diet fo r G roup 4. A specified amount o f diet was weighed into a labeled container. The required amount o f test material was weighed and transferred into a labeled container. Approximately 5 mL of acetone was added to the container and mixed manually. Increments of 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, 004561 Covance 6329-225 3M T-6314.1 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 muting bowl. The contents o f the mixing bowl were thoroughly mixed. 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 During the in-life phase, samples (approximately 100 g) were taken from each dose preparation for dose analyses and stored at room temperature. These samples were discarded on May 11, 1999 (see Protocol Deviations for exceptions). Method of Administration Dietary admixture was used because the potential route o f exposure in humans is oral. The dose preparations were administered ad libitum for at least 13 weeks, unless otherwise specified. Dose Analyses Analyses for the concentration of 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 the 3-ppm, 30-ppm, and 100-ppm dose preparations once pretest. One sample (approximately 100 g) each from the top, middle, and bottom o f the dose preparations mixed for homogeneity analyses were collected, divided into three subsamples for extraction and analysis, and analyzed for test material content. All samples were stored at room temperature until analyzed within 7 days o f mixing. Four samples (approximately 100 g each) were taken from the 1-ppm dose level concentration o f diet preparations mixed pretest. One sample was analyzed on the day o f 45* 004562 Covance 6329-225 3M T-6314.1 mixing and used as the baseline value. One sample was stored at room temperature for at least 19 days, then analyzed. A third sample was stored at room temperature for at least 32 days, then analyzed. The remaining sample was stored in a freezer set to maintain -10 to -30C for 8 weeks, then analyzed. In addition, two samples (approximately 100 g each) were taken from the 500-ppm dose preparation mixed pretest. One sample was analyzed on the day o f mixing. The second sample was stored at room temperature after at least 32 days, then analyzed. Two additional samples (approximately 100 g each) were taken from the 3-ppm dose preparation mixed for Weeks 9 through 12. One sample was stored at room temperature for at least 19 days, then analyzed. The second sample was stored at room temperature for at least 32 days, then analyzed. The sample collected for dose confirmation analysis was used as the baseline sample. During the in-life phase, samples (approximately 100 g) from all dose preparations were collected and analyzed for dose confirmation. All samples were stored at room temperature until analyzed. Clinical Observations The animals were observed twice daily (a.m. and p.m.) for mortality and moribundity (see Protocol Deviations for exceptions). Signs o f poor health or abnormal behavior were recorded as they were observed. At least once weekly, 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 o f treatment, and weekly thereafter. Food Consumption Individual food consumption data were recorded weekly during treatment. Food consumption was not measured during Week 5 for animals scheduled for sacrifice during Week 5. v 004S63 Covance 6329-225 3M T-6314.1 Ophthalmology Ophthalmic examinations were done before initiation o f treatment and during W eek 14. The pupils were dilated with 0.5% Mydriacyl*, and the eyes were examined by a veterinarian with an indirect ophthalmoscope. Clinical Pathology Blood samples were collected from 10 animals/sex/group during Weeks 5 and 14. Urine samples were collected from 10 animals/sex/group during W eek 14. Animals were fasted overnight, (see Protocol Deviations for exception) and urine was collected chilled (approximately 16 hours before blood sampling); water was provided ad libitum. Blood was collected from a jugular vein. Potassium EDTA was used as the anticoagulant for hematology tests. No anticoagulant was used for the clinical chemistry samples. Animals were bled in random order. The following were evaluated: 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 blood cell morphology Reticulocyte count smears were made and held for possible future examination. glucose urea nitrogen creatinine total protein albumin globulin total bilirubin cholesterol triglycerides Clinical Chemistry aspartate aminotransferase alanine aminotransferase gamma glutamyltransferase calcium inorganic phosphorus sodium potassium chloride X 004564 volume specific gravity pH protein glucose ketones Covance 6329-225 3M T-6314.1 Urinalysis bilirubin blood urobilinogen microscopic examination of sediment appearance Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination During W eeks 5 and 14, five animals/sex/group were fasted overnight, (see Protocol Deviations for exception) anesthetized with carbon dioxide, and blood (approximately 4 mL) was collected from a jugular vein. 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. Necropsy A necropsy was done on the Group 2 female that was sacrificed at an unscheduled interval. During W eek 5, five animals/sex/group were fasted overnight (see Protocol Deviations for exception), anesthetized with carbon dioxide, bled for serum PFOS samples, weighed, and exsanguinated. These animals were discarded without necropsy. The liver was removed from these animals, weighed, and collected for palmitoyl CoA oxidase and PFOS analysis. During Week 14, the remaining animals were fasted overnight, anesthetized with carbon dioxide, bled for clinical pathology tests (10 animals/sex/group with the exception o f Group 2 female) and serum PFOS samples (five animals/sex/group), weighed, exsanguinated, and necropsied. Liver samples were collected for palmitoyl CoA oxidase, PCNA, and PFOS analysis. Animals were necropsied in random order. 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. T$- 004565 Covane 6329-225 3M T-6314.1 Organ Weights After 13 weeks o f treatment, the following organs (when present) w ere weighed; paired organs were weighed together: a d r e n a l(2) brain 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 Imm unohistochemical Evaluation At the terminal sacrifice, representative samples o f the left lateral lobe o f the liver were collected from five animals/sex/group and preserved in zinc formalin. After fixation, samples were embedded in paraffin and shipped to Pathology Associates International (Frederick, Maryland) for proliferation cell nuclear antigen (PCNA) evaluation. In addition, liver sections were stained with hematoxylin and eosin and examined microscopically. Results o f the evaluation will be in Appendix 7. Palmitoyl-CoA Oxidase Tissue Collection and Analyses At the scheduled sacrifices, the right lateral lobe o f the liver was collected from each animal, flash-frozen in liquid nitrogen, and stored in a freezer set to maintain -60 to -80C until analyzed by Covance for palmitoyl CoA oxidase activity. Liver PFOS Analyses At the scheduled sacrifices, a portion o f the liver from each animal was flash-frozen in liquid nitrogen 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. 19 004566 Covance 6329-225 3M T-6314.1 Tissue Preservation The following tissues (when present) from the animal that was sacrificed at an unscheduled interval, or from each animal sacrificed at the terminal sacrifice were collected and preserved in 10% neutral-buffered formalin, unless otherwise specified: a d r e n a l(2) aorta brain cecum cervix colon duodenum epididymis (2) esophagus eye (2) femur with bone marrow (articular surface of 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 vesicle (2) skeletal muscle (thigh) skin spinal cord (cervical, mid-thoracic, and lumbar) spleen sternum with bone marrow stomach testis (2) thymus thyroid (2) with parathyroid trachea urinary bladder uterus vagina Zymbal's gland Histopathology Tissues (as appropriate) were embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically from each animal in the control and high-dose groups and from the low-dose animal that was sacrificed at an unscheduled interval. Due to microscopic findings noted in the high-dose group, the liver and stomach from animals in the mid-dose group, and the liver from animals in the low-dose group were also embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically. 004567 20 Covance 6329-225 3MT-6314.1 Macroscopic lesions from animals in the low- and mid-dose groups were embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically. Bone marrow smears from the femur of each animal were prepared at the scheduled sacrifice after 13 weeks o f treatment, stained with Wright's stain, and retained for possible examination. Statistical Analyses Levene's test (Levene, 1960) 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 (Winer, 1971a)] was used to analyze body weights, body weight changes, food consumption, continuous clinical pathology values; organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios. If the ANOVA was significant, Dunnett's t-test (Dunnett, 1964) was used for control versus treated group comparisons. Group comparisons (Groups 2 through 4 versus Group 1) were evaluated at the 5.0%, two-tailed probability level. Only data collected on or after the first day o f 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 at least 1 year. At least 1 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 and serum samples sent to the Sponsor and analysis data generated from these samples will be retained by the Sponsor. 21 00456S RESULTS Covan ce 6329-225 3M T-6314.1 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 74.0-78.0%, 84.0-96.7%, and 77.5-84.2% o f the theoretical concentrations for the diets containing 3, 30, and 100 ppm N-MeFOSE, respectively. These results indicate that the mixing procedure produced a homogeneous distribution o f the test material in the dose preparations; although variability generally appeared slightly greater at the 3 and 30-ppm dietary concentrations. Results o f stability analyses o f samples stored for 19 and 32 days at room temperature and 8 weeks under frozen conditions indicated that the mean concentrations ranged from 54.4-62.5% o f the initial concentrations o f 1 ppm for diet mixed pretest. Samples stored for 32 days at room temperature indicated that the mean concentration was 98.4% of the initial concentrations o f 500 p p m Results o f stability analyses o f samples stored for 19 and 32 days at room temperature indicated that the mean concentrations ranged from 93.2-94.0% o f the initial concentrations o f 1 ppm for diet mixed at Week 4. Samples stored for 19 days at room temperature indicated that the mean concentration was 89.0% o f the initial concentrations o f 3 ppm The mean concentrations o f the dose preparation analyses for all levels ranged from 63.7 to 110.0% of the theoretical concentrations. Inherent variability and lack o f sufficient sensitivity at low levels in the analytical method for measuring N-MeFOSE resulted in homogeneity, stability and routine analysis data that were in many cases outside o f the standard limits o f +/- 15%. These results will be reevaluated in conjunction with the analytical results from the blood and liver level determinations when they are provided by the sponsor. 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. One female given 3 ppm N-MeFOSE was sacrificed on Day 59 due to severe laceration o f the tail. There were no macroscopic or microscopic changes to indicate that its moribund condition was test material-related. All other animals survived to the scheduled sacrifice. 22 004569 Covance 6329-225 3M T-6314.1 No clinical observations were noted that were considered effects o f the test materiaL Ophthalmology Ophthalmic observations are summarized in Table 5; individual data are in Appendix 2. The Ophthalmology Report contains a discussion o f the data. Animals selected for the study had no lesions at the prestudy examination. No test material-related ophthalmic observations were noted at the W eek 14 exam inatioa Body Weights Body weight and body weight change data are summarized in Tables 6 and 7; individual body weight data are in Appendix 3. Test material-related lower body weights were noted for males given 3 and 30 ppm and for males and females given 100 ppm. Statistically significantly lower mean body weights were noted beginning at Week 4 and continuing through the end o f study for males and females given 100 ppm. Statistically significantly lower mean body weights were noted beginning at Week 7 and continuing through the end of study for males given 30 ppm. Body weight changes were statistically significantly lower in a sporadic manner for males given 30 ppm and for animals of both sexes given 100 ppm. Overall body weight changes (Weeks 1-14) were statistically significantly lower for all groups given N-M eFOSE. Food Consumption Food consumption data are summarized in Table 8; individual data are in Appendix 4. Although statistically significant only at W eek 13 for males given 100 ppm, food consumption was lower for males given 30 and 100 ppm when compared to those o f controls for most of the study. Females given 100 ppm had statistically significantly lower food consumption than those o f controls at Weeks 3, 4, 6, 7, 11, and 12. The overall mean food consumption for females fed the 100-ppm concentration was significantly lower by 17.5% when compared with that of the controls. 23 004570 Covance 6329-225 3M T-6314.1 Test Material Consumption Test material consumption data are summarized in Table 9; individual data are in Appendix 4. Animals were fed diets containing 3, 30, or 100 ppmN-M eFOSE, T-6314. The mean amounts o f test material consumed by the animals in these groups were 0.148 to 0.304 mg/kg/day; 1.390 to 3.094 mg/kg/day; and 5.054 to 10.291 mg/kg/day for males, respectively. Values for females were 0.184 to 0.319 mg/kg/day; 2.204 to 3.395; and 6.494 to 10.378, respectively. The overall mean test material consumption for males fed diets containing 3, 30, or 100 ppmN-MeFOSE, T-6314 were 0.203,2.041, and 6.844 mg/kg/day, respectively. The overall mean test material consumption for females fed diets containing 3, 30, or 100 ppm N-MeFOSE, T-6314 were 0.240, 2.588, and 7.702, respectively. Clinical Pathology Hematology, clinical chemistry, and urinalysis data are summarized in Tables 10 through 14; individual data are in Appendix 5. The Pathology Report contains a discussion o f the data. Dietary administration of N-MeFOSE was associated with lower hematocrit for males and females fed 100 ppm; higher urea nitrogen for males and females fed 100 ppm; higher albumin for males fed 100 ppm; lower globulin for males fed 30 or 100 ppm; lower cholesterol and triglycerides for males fed 30 or 100 ppm and females fed 100 ppm; higher alanine aminotransferase for males fed 100 ppm; and higher hepatic palmitoyl CoA oxidase for males and females fed 100 ppm. The effects were relatively mild with the exception o f those on cholesterol and triglycerides for the high-dose males; those effects were considered to be o f moderate severity. All of the test material-related clinical pathology findings were more prominent at Week 14 than at Week 5. Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination Results o f serum PFOS level determination will be reported separately by the Sponsor. 24 004571 Covance 6329-225 3M T-6314.1 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation Results o f cell proliferation and immunohistochemical evaluation provided by Pathology Associates International will be 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. Anatomic Pathology Terminal body weights, absolute organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios are summarized in Tables 15 and 16; incidences o f macroscopic and microscopic observations are summarized in Tables 17 and 18; the incidence o f severity o f microscopic observations is summarized in Table 19. Individual data are in Appendix 6. The Pathology Report contains a discussion o f the data. Statistically significant and test material-related changes in terminal body weights and liver weights were seen in males and/or females in the two highest dose groups. Statistically significant decreases were seen in the terminal body weights o f males fed 30 ppm and in both males and females fed 100 ppm of N-MeFOSE. Statistically significant increases were seen in the mean liver-to-body weight percentage and mean liver-to-brain weight ratio in males fed 30 ppm, in mean absolute liver weight and mean liver-to-body weight percentage in females fed 30 ppm, and in all liver weight parameters in males and females fed 100 ppm Test material-related macroscopic findings were noted at a low incidence in the liver and glandular stomach o f males and females in the 100 ppm dose group only. Liver findings included organs that were large and diffusely dark. In the glandular stomach, dark foci or areas were sometimes seen in the gastric mucosa. Test material-related microscopic findings were seen in the liver o f animals fed 30 and 100 ppm of N-MeFOSE and in the glandular stomach of males and females in the 100 ppm group only. No test material-related changes were seen in animals fed 3 ppm o f 25 004572 Covance 6329-225 3MT-6314.1 N-MeFOSE. In the liver, one or more test material-related findings affected all animals fed 100 ppm and included slight-to-moderate centrilobular o r diffuse hepatocellular hypertrophy, minimal-to-slight coagulative necrosis, minimal hepatocellular pigment, and minimal-to-slight centrilobular to midzonal or diffuse hepatocellular vacuolation. In animals fed 30 ppm, centrilobular hepatocellular hypertrophy was also seen, although the incidence and severity was decreased at this dose. In addition, a low incidence o f minimal hepatocellular vacuolation occurred in 30 ppm dose group males, and the liver o f a single female fed 30 ppm had minimal coagulative necrosis. A possible test material-related change in the glandular stomach o f animals fed 100 ppm was a relatively low incidence o f mucosal erosions. The erosions were o f minimal to slight severity and involved a very small portion o f the mucosal surface in all cases. CONCLUSIONS Based on the anatomic and clinical pathology results at 30 and 100 ppm and body weight effects at 3, 30, and 100 ppm, the no-observable-adverse-effect level was determined to be less than 3 ppm when N-MeFOSE is administered at concentrations o f 0, 3, 30 and 100 ppm to Crl:CD*(SD) IGS BR rats for at least 13 weeks through dietary administration. 26 004573 SIGNATURES Covance 6329-225 3M T-6314.1 Nii van Bruce-Konuah Study Coordinator Covance Laboratories Inc. Peter J. Thomford, PhD Study Director Covance Laboratories Inc. Date Date 27 004574 Covance 6329-225 3M T-6314.1 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 o f Single-Factor Experiments," Statistical Principles in Experimental Design. Second Ed., Ch. 3, pp. 149-260, McGraw-Hill: New York, New York (1971a). 28 004575 Covance 6329-225 3M T-6314.1 OPHTHALMOLOGY REPORT Ophthalmic examinations were done before initiation o f treatment and during W eek 14. Animals selected for the study had no lesions at the prestudy examination. No test material-related ophthalmic observations were noted at the W eek 14 examination. Donna J. Clemons, DVM, MS Diplomate, ACLAM Date 004576 29 Covance 6329-225 __________________________________________________________ 3M T-6314.1 PATHOLOGY REPORT SUMMARY The purpose o f this study was to assess the toxicity of the test material, N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE), when administered in the diet to rats for at least 13 weeks. The test material was administered at dose levels o f 3, 30, and 100 ppm. Dietary administration of N-MeFOSE was associated with lower hematocrit for males and females fed 100 ppm; higher urea nitrogen for males and females fed 100 ppm; higher albumin for males fed 100 ppm; lower globulin for males fed 30 or 100 ppm; lower cholesterol and triglycerides for males fed 30 or 100 ppm and females fed 100 ppm; higher alanine aminotransferase for males fed 100 ppm; and higher hepatic palmitoyl CoA oxidase for males and females fed 100 ppm. The effects were relatively mild with the exception o f those on cholesterol and triglycerides for the males fed 100 ppm; those effects were considered to be o f moderate severity. All o f the test material-related clinical pathology findings were more prominent at W eek 14 than at Week 5. Statistically significant and test material-related changes in terminal body weights and liver weights were seen in males and/or females in the two highest dose groups. Statistically significant decreases were seen in the terminal body weights o f males fed 30 ppm and in both males and females fed 100 ppm. Statistically significant increases were seen in the mean liver-to-body weight percentage and mean liver-to-brain weight ratio in males fed 30 ppm, in mean absolute liver weight and mean-liver-to-body weight percentage in females fed 30 ppm, and in all liver weight parameters in males and females fed 100 ppm. Test material-related macroscopic findings were noted at a low incidence in the liver and glandular stomach o f males and females in the 100 ppm dose group only. Liver findings included organs that were large and diffusely dark. In the glandular stomach, dark foci or areas were sometimes seen in the gastric mucosa. Test material-related microscopic findings were seen in the liver o f animals fed 30 and 100 ppm o f N-MeFOSE and in the glandular stomach of males and females in the 100 ppm group only. No test material-related changes were seen in animals fed 3 ppm o f N-MeFOSE. In the liver, one or more test material-related findings affected all animals 0 4 577 Covance 6329-225 3M T-6314.1 fed 100 ppm, and included slight-to-moderate centrilobular or diffuse hepatocellular hypertrophy, minimal-to-slight coagulative necrosis, minimal hepatocellular pigment, and minimal-to-slight centrilobular to midzonal or diffuse hepatocellular vacuolation. In animals fed 30 ppm, centrilobular hepatocellular hypertrophy was also seen, although the incidence and severity was decreased at this dose. In addition, a low incidence o f minimal hepatocellular vacuolation occurred in 30 ppm dose group males, and the liver o f a single female fed 30 ppm had minimal coagulative necrosis. A possible test material-related change in the glandular stomach o f animals fed 100 ppm was a relatively low incidence o f mucosal erosions. The erosions were o f minimal to slight severity and involved a very small portion o f the mucosal surface in all cases. METHODS Four groups of Crl:CD (SD) IGS BR rats (20 animals/sex/group) were fed diets containing the test material at a dose level o f 0 (control group; fed basal diet only), 3, 30, or 300 ppm. During Week 5, five animals/sex/group were sacrificed to obtain liver samples for determination o f hepatic palmitoyl CoA oxidase activity (by Covance) and analysis for PFOS and metabolites (by 3M). One female fed 3 ppm was sacrificed and necropsied during Week 9 because of poor health (unscheduled sacrifice). The remaining animals were sacrificed and necropsied during Week 14 (terminal sacrifice). Blood was collected for hematology and clinical chemistry tests during W eeks 5 and 14. Urine was collected for urinalysis tests during Week 14. At necropsy, macroscopic observations were recorded, organ weights were obtained (terminal sacrifice only), and tissues were placed in fixative as specified by the protocol. In addition, samples o f liver were collected at the terminal sacrifice for evaluation of proliferation cell nuclear antigen (PCNA; by Pathology Associates International; five animals/sex/group), and both scheduled sacrifices for determination of hepatic palmitoyl CoA oxidase activity (by Covance) and analysis for PFOS and metabolites (by 3M). Microscopic examinations were done on protocol-required tissues from all control and high-dose animals sacrificed during Week 14 and the 3 ppm dose group female sacrificed in a moribund condition during Week 9 (unscheduled sacrifice). In addition, livers, stomachs, and macroscopic lesions were examined from all terminal sacrifice animals fed 30 ppm, and macroscopic lesions and livers only were examined from animals fed 3 ppm. *44- 004578 Covance 6329-225 3M T-6314.1 Statistically significant differences cited in the Results and Discussion section are based on comparisons between the control and treated groups. RESULTS AND DISCUSSION Mortality One female fed 3 ppm (Animal No. C96016) was sacrificed during Week 9 (Day 59) because o f poor health. All other animals survived to the respective scheduled sacrifice. Clinical Pathology W eeks 5 and 14. There were several statistically significant or otherwise notable differences for clinical pathology results between control and treated animals. Differences considered to be effects o f the test material were lower hematocrit for males and females fed 100 ppm; higher urea nitrogen for males and females fed 100 ppm; higher albumin for males fed 100 ppm, lower globulin for males fed 30 or 100 ppm; lower cholesterol and triglycerides for males fed 30 or 100 ppm and females fed 100 ppm; higher alanine aminotransferase for males fed 100 ppm; and higher hepatic palmitoyl CoA oxidase for males and females fed 100 ppm. The effects were relatively mild with the exception o f those on cholesterol and triglycerides for the males fed 100 ppm; those effects were considered to be o f moderate severity. All o f the test material-related clinical pathology findings were more prominent at Week 14 than at Week 5. The mild effects on hematocrit and globulin were consistent with animals failing to gain weight appropriately. Although mildly higher urea nitrogen and albumin suggested a relative dehydration for animals given 100 ppm, there were no effects on urine volume or urine specific gravity consistent with dehydration. The mild effect on alanine aminotransferase was indicative of the hepatocellular degeneration, and mildly higher hepatic palmitoyl CoA oxidase was indicative o f peroxisomal proliferation. The effects on cholesterol and triglycerides were the most prominent findings, and suggested lipid metabolism by the liver was altered. O f uncertain relationship to administration of the test material was statistically lower mean corpuscular volume for females fed 100 ppm. The difference for mean corpuscular volume became smaller over time (i.e., from Week 5 to Week 14). Other statistically .99 004579 Covance 6329-225 3M T-6314.1 significant differences were considered incidental and unrelated to administration o f the test material. Anatomic Pathology U nscheduled D eaths. The one female fed 3 ppm that was sacrificed in a moribund condition on Day 59 (Animal No. C96016) had no macroscopic or microscopic changes to indicate that its moribund condition was test material-related. Term inal Sacrifice Term inal Body W eights and O rgan W eights. Test material-related changes were seen in the terminal body weights and in absolute and relative liver weights in animals fed 30 and 100 ppmN-M eFOSE. Mean terminal body weights were statistically significantly decreased in males and females that were fed 100 ppm o f N-MeFOSE and in males only fed 30 ppm. The decreased mean body weights at both dose levels were considered to be test material-related. Statistically significant and test material-related increases were seen in the mean liver-to-body weight percentage and the mean liver-to-brain weight ratio in males fed 30 ppm, in mean absolute liver weight and mean liver-to-body weight percentage in females fed 30 ppm, and in all liver weight parameters in males and females fed 100 ppm. The liver weight increases correlated macroscopically with large livers in 3 o f 15 males in the 100 ppm dose group and microscopically with the presence o f hepatocellular hypertrophy in all males and females in the high-dose group. Additional statistically significant absolute or relative organ weight changes affected several other organs in both sexes and in multiple dose groups. Because there were no macroscopic or microscopic findings that correlated with the weight changes, the remaining organ weight variations were considered to be within the range o f normal biologic variation o r were attributed to the lower body weights in treated versus control animals. M acroscopic Findings. Test material-related macroscopic findings were noted at a low incidence in the liver and glandular stomach o f males and females fed 100 ppm *4. M458G Covance 6329-225 3M T-6314.1 N-MeFOSE. Livers that were large were seen in 3 o f 15 males and in 0 females fed 100 ppm, and diffusely dark livers occurred in 2 o f 15 males and 1 o f 15 females fed 100 ppm. No liver changes occurred in animals fed the control material or in animals fed lower doses o f N-MeFOSE. The large and diffusely dark livers correlated microscopically with hepatocellular hypertrophy in the affected animals. In the glandular stomachs, dark foci or areas occurred at an incidence o f 0 o f 15, 1 o f 15, 0 o f 15, and 2 o f 15 in males, and at an incidence o f 0 o f 15, 0 o f 14, 0 o f 15, and 3 o f 15 in females in the control, 3 ppm, 30 ppm, and 100 ppm groups respectively. The dark foci or areas generally correlated microscopically with small erosions in the glandular mucosa. Diffuse reddening and mottling o f the thymus and mandibular lymph nodes as well as red foci or areas in the thymus were relatively common findings and frequently correlated microscopically with hemorrhage in the affected organs. Because these findings did not occur in a dose-related manner and because rats in multiple dose groups, including control males, were sometimes affected, the findings were considered to be agonal changes that were not associated with test material administration. All remaining macroscopic findings were considered to be spontaneous and incidental and not related to test material administration. M icroscopic Findings. Test material-related microscopic findings were seen in the liver o f animals fed 30 and 100 ppm o f N-MeFOSE and in the glandular stomach o f males and females in the 100 ppm group only. There were no test material-related findings in the livers o f animals fed 3 ppm. Test material-related findings in the liver included hepatocellular hypertrophy, coagulative necrosis, hepatocellular pigment, and hepatocellular vacuolation. The incidence and severity o f these findings tended to be greater in 100 ppm animals. The incidence o f pertinent liver findings is presented in Text Table 1. 004581 Text Table 1 Covance 6329-225 3M T-6314.1 Incidence o f Selected Microscopic Findings in the Liver Group Number/Sex Number Examined 1M 2M 3M 4M 15 15 15 15 IF 2F 3F 4F 15 14 15 15 Hypertrophy, hepatocellular, diffuse Hypertrophy, hepatocellular, Centrilobular Necrosis, coagulative Pigment, hepatocellular Vacuolation, hepatocellular, centrilobular to midzonal Vacuolation, hepatocellular, diffuse 0 0 0 0 0 0 000 0 14 15 003 002 027 0 22 0001 0 0 7 14 0 0 10 0007 0002 0000 As noted in the above table, hepatocellular hypertrophy generally affected centrilobular areas o f the liver in animals fed 30 and 100 ppm, but the liver was more diffusely hypertrophied in one female fed 100 ppm. The hypertrophic hepatocytes were enlarged with abundant cytoplasm that often had a granular to globular eosinophilic appearance. In some animals in the high-dose group (two males and seven females), the cytoplasm o f hepatocytes also contained minimal amounts o f a brown granular pigment at the periphery o f the cell In addition, liver cells frequently were vacuolated (see Text Table 1), particularly in males given 100 ppm, with the vacuolation generally affecting hepatocytes in centrilobular and midzonal areas. Diffuse hepatocellular vacuolation was also seen in two males in each o f the 30 and 100 ppm dose groups, but in no other animals. Lastly, minimal to slight coagulative necrosis seen in 3 o f 15 males fed 100 ppm and 1 o f 15 females fed 30 ppm was likely related to dietary administration o f the test material since no control or 3 ppm dose group animals were similarly affected. A possible test material-related change in the glandular stomach was the presence o f mucosal erosions. The erosions were o f minimal to slight severity and involved a very small portion o f the mucosal surface in all cases. The erosions were seen with an incidence o f 0 o f 15, 0 o f 15, and 2 o f 15 in males, and at an incidence o f 0 o f 15, 0 o f 15, and 3 of 15 in females in the control, 30 ppm, and 100 ppm groups respectively. The presence of erosions microscopically generally correlated with the dark foci or areas seen T5S 004582 Covance 6329-225 3M T-6314.1 in the gastric mucosa at necropsy. One male fed 3 ppm also had a slight gastric erosion that was collected as a gross lesion at necropsy. Since no erosions were seen in any o f the animals' stomachs examined from animals fed 30 ppm, the lesion in the 3 ppm male was considered unlikely to be test material-related. All remaining microscopic findings were considered to be spontaneous and incidental changes and typical o f rats o f this age and strain. Robert L. Hall, DVM, PhD Diplomate, ACVP (Clinical Pathology) Johnnie J. Eighmy, DVM, MS Diplomate, ACVP Diplomate, ABT Date Date 36 \ X. 004583 COMMENTS ON THE DATA Covance 6329-225 3M T-6314.1 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, o r individual values) may differ slightly from those in other tables, from individually calculated data, or from statistical analysis data. Neither the integrity nor the interpretation of the data was affected by these differences. 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 of 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 o f treatment is "Day l, 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). 004584 COMMENTS ON THE DATA (Continued) Covance 6329-225 3M T-6314.1 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. 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 food efficiency and 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 anatomic pathology are explained on the individual data tables or the codes sheets. 38 004585 COMMENTS ON THE DATA (Continued) Covance 6329-225 3M T-6314.1 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 of Interval- First Body Weight of Interval______ Day of Last Body Weight of Interval- Day of first Body Weight of Interval and: Day Factor = (Food Consumption Start Day- Day of First Body Weight of Interval) + Consumption Interval 2 and: Food Consumption Interval = Food Consumption End Day- Food Consumption Start Day **39- 4S86 CODES, ABBREVIATIONS, AND UNITS General Codes and Abbreviations Codes for Clinical Pathology Abbreviations and Units for Clinical Hematology Abbreviations and Units for Clinical Chemistry Abbreviations and Units for Clinical Urinalysis Codes for Anatomic Pathology Covance 6329-225 3MT-63I4.1 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. 40. 004587 Covane 6329-225 3M T-6314.1 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 of measurements in a group. Arithmetic mean. Standard deviation. Group mean is significantly different from the mean o f the control group (Group 1) at p s 0.05. No value; not applicable; not present. Present. Comment found at the end o f each group for each sex. Unscheduled. Observations transferred from the in-life module o f the data collection system to the necropsy module for reference during necropsy. Observations are duplicates o f the last in-life observations. Terminal body weight. Number. Clinical observation. Animal Death Codes: 1 T M Interim sacrifice 1. Terminal sacrifice. Sacrificed at an unscheduled interval. >4. 045S8 NS QS/QNS NR FS SC SH H SL L SI I NF U DT/DOT DB TJ TE RE EE SE PC PD PI PL PA CO HB PLASMO NO AGG FR UTD NO COAG Covance 6329-225 3M T-6314.1 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 004589 4& Covance 6329-225 3M T-6314.1 Codes for Clinical Pathology (Continued) RESULTS NOT INCLUDED IN STATISTICAL ANALYSES Hemolyzed clinical chemistry or coagulation samples Samples from animals at unscheduled intervals Prothrombin times (PT) greater than 50 seconds Activated partial thromboplastin times (PTT) greater than 110 seconds Bleed times (BLETIME) greater than 30 minutes CODES FOR BLOOD CELL MORPHOLOGY The following scale was used to measure the degree o f anisocytosis (ANISO), poikilocytosis (POIK), polychromasia (POLY), hypochromasia (HYPO), or basophilic stippling (BASTIP) or the presence o f Howell-Jolly bodies (HJBODY), toxic neutrophils (TOXNEUT), or atypical lymphocytes (ATYPLYM): Scale - 1 2 3 4 Degree Normal for the species Slight Moderate Marked Not applicable Presence Not present Rare Few M oderate 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 004590 Codes for Clinical Pathology (Continued) Covance 6329-225 3MT-6314.I URINE CHEMISTRY MULTISTIX* STRIP Urine Glucose + ++ +++ ++++ +++++ Negative 100 mg/dL 250 mg/dL 500 mg/dL 1,000 mg/dL 2,000 mg/dL Urine Ketone + ++ +++ ++++ +++++ Negative 5 mg/dL 15 mg/dL 40 mg/dL 80 mg/dL 160 mg/dL Urine Blood - Negative + Small ++ Moderate +++ Large Urine Urobilinogen + ++ +++ ++++ 0.2 mg/dL 1 mg/dL 2 mg/dL 4 mg/dL 8 mg/dL (1 mg = approximately 1 Ehrlich unit) Urine Bilirubin - Negative + Small ++ Moderate H-+ Large URINE SEDIMENT Cells, Crystals, Casts, and Comments A Amorphous urates B Amorphous phosphates C Uric acid D Triple phosphates E Calcium oxalate F Calcium carbonate G Granular casts H Hyaline casts I Cellular casts J Waxy casts K Unknown crystal P Mucous threads Q Sperm R Fecal contamination S Pinworm ova found T Pinworm larvae found U Parasite ova found 0 Not present 1 1-5 per field 2 6-10 per field 3 11-20 per field 4 >20 per field Bacteria 0 Not present 1 Few 2 Moderate 3 Many 004591 V Covance 6329-225 3M T-6314.1 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 X106///L) HGB (G/DL) HCT (%) MCV (FL) MCH (PG) MCHC (%) PLT (E3/UL o r XlOV/zL) MPV (FL) RETTC (%) RETTC (E3/UL o r X103/^L ) HEINZ (%) ESR (MM/HR) PT (SEC) PTT (SEC) TT (SEQ ACT (SEC) FBR (MG/DL) FDP (UG/ML) PAGG/COL (%) PAGG/ADP (%) ANTIPLAS (%) BLE TIME (SEC) METHGB (%) PLA HGB (MG/DL) M/E RATIO EST M/E RATIO WBC (E3/UL or X10V//L) NRBC (/100 WBC) COR WBC (E3/UL or XIOV^L) N-SEG (E3/UL or X103//iL) and % N-BAND (E3/UL or X103//dL) and % LYMPH (E3/UL or X103/^L ) and % MONO (E3/UL or X103//L) and % EOSIN (E3/UL o r X103//uL) and % BASO (E3/UL or X103/yuL) and % ANISO (-,1,2,3) POLY (-,1,2,3) -5, 04592 Covance 6329-225 3M T-6314.1 Abbreviations and Units for Clinical Hematology (Continued) Test Poikilocytosis 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) 4593 Covance 6329-225 3M T-6314.1 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) ALKPHOS (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) 004594 Covance 6329-225 3M T-6314.1 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) >8* 004595 Abbreviations and Units for Clinical Urinalysis Covance 6329-225 3M T-6314.1 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 o f urine sediment Red blood cells per high-power field White blood cells per high-power field Epithelial cells per high-power field Bacteria per high-power field Casts per low-power field Crystals per low-power field Urine appearance Comments Abbreviation (Units) U VOL (ML) 8 HR VOL (ML) SP GR U OSMO (MOSM/KG) QUAN PRO (MG/DL) PRO EXC (MG) UPH U PRO (MG/DL) UGLU UKET U B IL I U BLOOD UROBILI U RE SUB RBC (PER HPF) WBC (PER HPF) EPITH (PER HPF) BACT (PER HPF) CASTS (PER LPF) CRYSTALS (PER LPF1 or PER LPF2) URINE APP1 or URINE APP2 COMMENTS Miscellaneous Codes and Abbreviations for Clinical Pathology Fecal occult blood Fecal parasite detection Hemolytic potential Osmolality Not applicable Not applicable Not applicable OSMO (MOSM/KG) 4S96 Code 1 T M Codes for Anatomic Pathology Definition ANIMAL DEATH CODES Interim sacrifices 1 Terminal sacrifice Sacrificed at an unscheduled interval Covance 6329-225 3M T-6314.1 EX NOT TAKEN MISSING 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 Codes Prefacing Neoplastic Findings B- Primary, benign neoplasm M- Primary, malignant neoplasm N- Metastatic neoplasm I- Locally invasive neoplasm X- Other neoplasm 50. 004597 Codes for Anatomic Pathology (Continued) Covance 6329-225 3M T-6314.1 Code Definition D istribution of Findings Focal Diffuse Multifocal Grades for Severity or Amount 1 Minimal - the least amount o f 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 o f change with possible loss o f function o f the affected cells or organs 5 Severe - a great amount of change with probable loss o f function o f the affected cell or organs and frequently involves large areas o f the organ O ther Microscopic Codes TL Total P Finding present Finding not present MN Mean 00459 Covance 6329-225 3M T-6314.1 Codes for Anatomic Pathology (Continued) TISSUE ABBREVIATIONS Abbreviation LN GL STOMACH, GL STOMACH, NONGL SALIV GL, MANDIB LN, ANT MES/PANC AUDITORY SEB GL LACRIMAL GLAND, EX HEMATO NEOPLASIA LACRIMAL GL, INT CAVITY, ABDOM SALIV GL,PAROTID LN, TRACHEOBRON 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 4* 004599 Covance 6329-225 3M T-6314.1 Table 1 Results of Homogeneity Analyses (ppm) Mixed 8/20/98 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T6314) IN RATS Samples Location Replicate 3 T6314 (ppm) 30 100 Top 1 2.19 33.7 79.4 2 2.43 27.8 76.5 3 2.09 25.6 76.7 Mean 2.24 (74.7)a 29.0 (96.7) 77.5 (77.5) Middle 1 2 3 Mean 2.24 2.27 2.14 2.22 (74.0) 25.2 25.3 25.1 25.2 (84.0) 75.0 79.7 89.5 81.4(81.4) Bottom 1 2 3 Mean 2.03 3.04 1.94 2.34 (78.0) 23.7 27.6 29.4 26.9 (89.7) 83.2 81.6 87.8 84.2 (84.2) a Each value in parenthesis is the percent o f theoretical. X 004600 Covance 6329-225 3MT-6314.1 Table 2 Results o f Stability Analyses (ppm) Mixed 8/20/98 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T6314) IN RATS Storage Conditions T6314 (ppm) Replicate 1 500 Initial 1 2 Mean 1.88 0.954 1.42(142) 415 468 442 (88.4)a 19 day, room temperature 1 2 Mean 0.733 0.811 0.772 (77.2) - - - 32 day, room temperature 1 2 Mean - - 444 425 435 (87.0) 32 day, room temperature1* 1 2 Mean 0.709 0.850 0.780 (78.0) - - 8 week, frozen 1 2 Mean 0.779 0.995 0.887 (88.7) - a Each value in the parenthesis is the percent o f theoretical, b Reinjected 004601 54 Covane* 6329-225 3M T-6314.1 Table 2 Results o f Stability Analyses (ppm) Mixed 9/24/98 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T6314) IN RATS T6314 (ppm) Storage Conditions Replicate 500 1 Initial 1 2 Mean - - 0.788 0.656 0.722 (72.2)a 19 day, room temperature 1 2 Mean - 0.707 0.651 0.679 (67.9) 32 days, room temperature 1 2 Mean - - 0.688 0.657 0.673 (67.3) a Each value in the parenthesis is the percent o f theoretical. 004602 Covane* 6329-225 3M T-63I4.1 Table 2 Results of Stability Analyses (ppm) Mixed 10/22/98 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T6314) IN RATS T6314 (ppm) Storage Conditions Replicate 3 Initial 1 2 Mean 2.24 2.49 2.37 (79.0)a 19 day, room temperature 1 2 Mean 1.89 2.33 2.11 (70.3) a Each value in the parenthesis is the percent o f theoretical. 004603 Table 3 Covance 6329-225 3M T-6314.1 Results of Dose Preparation Analyses (ppm) 13-WEEK TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Week Replicate 0 3 T-6314 (ppm) 30 100 1-4 1-4C l-4d 1 2 Mean 1 2 Mean 1 2 Mean a a - _ - - _ - - 2.16 29.7 2.12 27.0 2.14 (71.3)b 28.4 (94.7) 87.3 85.2 86.3 (86.3) 1.98 1.84 1.91 (63.7) - - - 2.48 2.28 2.38 (79.3) _ - - _ - - 5-8 1 a 3.55 27.9 89.3 2 a 3.05 27.0 82.3 Mean a 3.30(110) 27.5 (91.7) 85.8 (85.8) 9/12 1 a 2.24 27.6 89.7 2 a 2.49 26.8 87.2 Mean a 2.37 (79.0) 27.2 (90.7) 88.5(88.5) 13/14 1 2 Mean a a a 2.51 2.42 2.47 (82.3) 26.2 26.4 26.3 (87.7) 98.1 98.7 98.4 (98.4) a Below the limit o f quantitation (<0.5 ppm), b Each value in parenthesis is the percent o f theoretical, c Retest, d Retention. 004604 DAYS 1-93 CATEGORY KEYWORD QUALIFIER *** TOP OF LIST *** APPEARANCE LIMITED USE LIMB-HIND-LEFT MALOCCLUSION MISSING TAIL-DISTAL TEETH SWOLLEN LIMB-HIND-LEFT THIN DISCHARGE GENITAL RED IN COLOR NASAL RED IN COLOR EYES RED DISCHARGE EYES RESPIRATION AUDIBLE Tedile 4 Summary of Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS SEX: GROUP : DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED --- -- MALE--- -- -- -- FEMALE-- 12 34 12 3 4 0 3 30 100 0 3 30 100 20 20 20 20 20 20 20 20 00001000 36341331 00000001 00010000 00001000 01000000 10000000 00010000 00010000 00010000 Covance 6329-225 3M T-6314.1 PAGE: 1 004605 58 DAYS 1-93 CATEGORY KEYWORD QUALIFIER SKIN A PELAGE BLACK SKIN TAIL-DISTAL SORE/SCAB MOUTH TAIL YELLOW HAIR COAT PENIS *** END OF LIST ** Table 4 Summary of Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- 14ALE-- ---- -- -- FE1 [ALE-- 12341234 0 3 30 100 0 3 30 100 20 20 20 20 20 20 20 20 10000000 00000010 00000100 00100000 Covance 6329-225 3M T- 6314.1 PAGE: 2 tt. f4 004606 !4 WEEK 14 CATEGORY KEYWORD QUALIFIER * * * TOP OF LIST *** CONJUNCTIVA CONJUNCTIVITIS EYES EYE-LEFT RETINA RETINAL DEGENERATION-FOCAL EYE-RIGHT *** END OF LIST *** Table 5 Summary of Ophthalmic Observations Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- MALE-1234 0 3 30 100 --FEMALE-1234 0 3 30 100 15 15 15 15 15 15 15 15 01000000 0 00 10 0 0 0 0 01 00 0 00 Covane 6329-225 3M T-6314.1 PAGE: 1 004607 60 I Table 6 Summary of Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS WEEK SEX: GROUP: DOSE: UNITS: 1 0 PPM 1N 20 MEAN 210 S.D. 11.2 2N 20 MEAN 263 S.D. 16.0 3N 20 MEAN 313 S.D, 21.5 4N 20 MEAN 355 S.D. 25.1 5N 20 MEAN 385 S.D. 28.6 6N 15 MEAN 410 S.D. 24.4 7N 15 MEAN 435 S.D. 24.5 2 3 PPM 20 211 10.2 20 263 13.4 20 314 16.6 20 355 19.9 20 382 20.5 15 401 23.9 15 424 26.8 3 30 PPM 20 211 11.7 20 263 13.8 20 313 17.1 20 351 20.5 20 378 21.6 15 393 21.1 15 414* 23.2 4 100 PPM 20 208 11.9 20 258 13.1 20 303 15.9 20 335* 18.5 20 359* 21.4 15 378* 19.2 15 403* 21.8 1 0 PPM 20 159 10.0 20 185 11.9 20 203 16.0 20 224 17.4 20 23 6 21.7 15 247 22.9 15 255 25.5 2 3 PPM 20 159 11.6 20 180 15.5 20 200 25.0 20 222 23.3 20 230 23.1 15 237 27.3 15 244 25.3 3 30 PPM 20 160 9.2 20 183 11.8 20 203 15.2 20 223 14.1 20 233 14.6 15 235 14.7 15 245 14.5 4 100 PPM 20 158 10.3 20 178 12.6 20 194 17.5 20 207* 16.6 20 215* 16.2 15 223* 21.0 15 229* 21.9 Covance 6329-225 3M T-6314.1 PAGE: 1 004608 61 Table 6 Summary of Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS WEEK SEX: GROUP: DOSE: UNITS: --------- MALE123 0 3 30 PPM PPM PPM 8N 15 MEAN 452 S.D. 26.9 9N 15 MEAN 47 5 S.D. 28.1 10 N 15 MEAN 490 S.D. 29.7 11 N 15 MEAN 503 S.D. 33.0 12 N 15 MEAN 516 S.D. 34.1 13 N 15 MEAN 532 S.D. 36.1 14 N 15 MEAN 547 S.D. 38.6 15 439 27.0 15 461 25.8 15 475 28.4 15 485 31.9 15 496 30.6 15 510 30.0 15 521 27.6 15 428* 28.6 15 448* 28.4 15 460* 30.2 15 471* 31.9 15 480* 33.8 15 490* 30.1 15 491* 37.1 4 100 PPM 15 416* 22.9 15 430* 24.6 15 442* 23.7 15 453* 24.9 15 462* 24.8 15 471* 25.1 15 481* 25.3 1 0 PPM 15 259 26.8 15 267 26.3 15 275 29.2 15 281 31.3 15 287 33.2 15 293 36.2 15 300 35.9 2 3 PPM 15 245 26.5 15 256 26.9 14 259 23.6 14 264 26.9 14 266 25.7 14 273 29.3 14 280 26.7 3 30 PPM 15 248 14.9 15 257 17.6 15 263 16.8 15 266 16.1 IS 270 18.0 15 274 19.6 15 279 19.3 4 100 PPM 15 231* 22.5 15 238* 22.3 15 241* 22.6 15 245* 23.7 15 246* 24.3 15 250* 24.5 15 254* 24.5 Covance 6329-225 3M T-6314.1 PAGE: 2 A , it. 4 004609 62 I Table 7 Summary of Body Weight Change Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS WEEK SEX: GROUP: DOSE: UNITS: 1 0 PPM 1-2 N MEAN S.D. 2-3 N MEAN S.D. 3-4 N MEAN S.D. 4-5 N MEAN S.D. 5-6 N MEAN S.D. 6-7 N MEAN S.D. 7-8 N MEAN S.D. 20 53 6.5 20 49 9.3 20 42 10.4 20 31 7.6 15 19 7.8 15 26 3.3 15 16 4.3 --------- MALE2 3 PPM 3 30 PPM 20 52 5.4 20 51 5.6 20 41 5.5 20 27 3.6 15 17 3.9 15 23 4.4 15 15 4.9 20 53 4.6 20 49 5.0 20 39 5.2 20 26 4.9 15 17 4.7 15 21* 3.6 15 14 8.1 4 100 PPM 20 50 3.8 20 45* 4.6 20 32* 4.1 20 24* 6.1 15 14 4.9 15 24 6.2 15 13 3.8 1 0 PPM 20 26 6.7 20 19 8.5 20 21 9.3 20 11 7.6 15 7 6.8 15 9 5.3 15 4 5.1 2 3 PPM 20 21 11.7 20 20 13.3 20 22 15.9 20 8 7.0 15 12 5.6 15 6 5.0 15 2 3.5 3 30 PPM 20 23 5.7 20 21 8.0 20 19 6.8 20 10 4.6 15 5 4.9 15 10 3.7 15 4 3.5 4 100 PPM 20 20 6.1 20 16 7.4 20 13* 7.1 20 8 4.9 15 7 4.4 15 6 3.8 15 2 4.6 Covance 6329-225 3M T-6314.1 PAGE: 1 f 1 S' 004610 63 WEEK spy - GROUP: DOSE: UNITS: 1 0 PPM 8-9 N MEAN S.D. 9-10 N MEAN S.D. 10-11 N MEAN S.D. 11-12 N MEAN S.D. 12-13 N MEAN S.D. 13-14 N MEAN S.D. 1-14 N MEAN S.D. 15 23 3.9 15 16 5.4 15 12 4.7 15 13 5.1 15 16 4.2 15 15 5.0 15 338 35.8 Table 7 Summary of Body Weight Change Data (g) 13- WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 2 3 PPM 15 22 4.3 15 15 4.9 15 10 19.0 15 10 11.5 15 15 6.3 15 10 5.0 15 307* 27.0 3 30 PPM 15 20 3.7 15 12 5.7 15 11 4.1 15 9* 4.3 15 10* 10.6 15 1 29.5 15 282* 35.5 4 100 PPM 15 14* 10.3 15 12 7.5 15 11 3.1 15 9* 2.5 15 9* 4.0 15 10 3.0 15 270* 21.5 1 0 PPM 15 8 7.1 15 7 6.3 15 6 4.7 15 6 5.9 15 6 7.2 15 6 7.7 15 141 30.7 2 3 PPM 15 11 3.5 14 5 3.8 14 5 5.5 14 2 4.3 14 8 5.6 14 6 7.7 14 121* 17.8 3 30 PPM 15 9 4.9 15 6 4.4 15 3 5.2 15 4 4.5 15 4 5.7 15 5 5.4 15 120* 14.9 4 100 PPM 15 7 3.1 15 3 2.5 15 3 2.8 15 2 4.8 15 4 2.8 15 3 4.1 15 96* 17.0 Covance 6329-225 3M T-6314.1 PAGE: 2 004611 64 Table 8 Summary of Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS WEEK SEX: --------------------- MALE---------------------- GROUP : i 2 3 4 DOSE: 0 3 30 100 UNITS: PPM PPM PPM PPM ---------------------FEMALE 12 03 PPM PPM 3 30 PPM 1N 20 MEAN 169 S.D. 12.3 2 13 19 MEAN 17 6 S.D. 12.9 3N 20 MEAN 181 S.D. 16.2 4N 18 MEAN 186 S.D. 14.3 5N 15 MEAN 177 S.D. 20.5 6N 15 MEAN 191 S.D. 14.7 7N 14 MEAN 191 S.D. 17.7 20 168 9.6 19 177 11.6 19 183 16.5 19 186 13.6 14 17 6 14.7 15 190 17.5 15 192 15.4 20 171 13.8 19 178 11.3 20 186 14.6 20 191 15.7 14 172 13.4 15 190 22.8 15 184 23.2 20 168 8.6 20 17 6 9.1 19 173 8.0 20 17 6 10.8 15 166 9.4 15 182 9.4 15 182 8.5 19 126 13.5 19 130 15.6 19 138 16.7 17 135 17.7 14 129 16.1 12 138 18.8 12 144 15.1 16 127 16.5 16 124 24.3 16 135 16.8 16 134 14.6 12 122 17.1 13 131 13.7 12 138 21.1 17 138 24.9 13 137 17.1 16 144 18.7 13 138 10.7 8 122 7.4 12 150 20.5 6 136 6.9 4 100 PPM 18 122 19.5 16 116 14.3 19 115* 13.3 20 121* 17.2 15 115 15.6 15 121* 14.1 14 117* 13.8 Covance 6329-225 3M T-6314.1 PAGE: 1 004612 65 I WEEK SEX: GROUP: DOSE: UNITS: 1 0 PPM 8 9 10 11 12 13 1-13 N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. 13 185 10.9 15 190 20.8 14 187 24.3 14 191 29.7 13 185 14.6 13 187 20.7 9 2397 102.5 Table 8 Summary of Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS MALE---------23 3 30 PPM PPM 4 100 PPM 12 188 12.6 15 189 16.6 15 180 27.5 15 183 17.5 15 181 19.4 15 178 12.3 10 2329 115.5 14 179 15.2 15 180 19.6 15 176 18.8 14 176 22.1 15 175 19.4 15 160 46.1 13 2271 145.8 15 176 10.0 15 175 9.2 15 174 10.2 14 173 9.7 15 173 11.3 15 168* 8.9 13 2283 77.0 1 0 PPM 12 134 19.8 11 130 17.1 13 139 36.5 10 136 22.8 13 137 29.3 11 133 26.4 8 1769 182.0 2 3 PPM 12 13 6 12.0 12 131 13.4 13 128 19.2 12 124 11.9 13 129 15.2 11 120 17.2 4 1667 184.7 3 30 PPM 11 138 11.0 9 146 32.1 12 143 29.6 11 145 32.6 15 146 38.0 13 143 34.8 4 1683 24.1 4 100 PPM 14 120 15.6 14 118 15.7 14 115 13.9 13 112* 12.5 14 114* 13.3 14 119 26.4 10 1505* 173.4 Covance 6329-225 3M T-6314.1 PAGE: 2 / k 1 1 f' 4 004613 66 fi I Table 9 Summary of Test Material Consumption Data Img/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS WEEK SEX: --------------- MALE--------------- GROUP: 2 3 4 DOSE: 3 30 100 UNITS: PPM PPM PPM -------------- FEMALE----------234 3 30 100 PPM PPM PPM 1N MEAN S.D. 2N MEAN S.D. 3N MEAN S.D. 4N MEAN S.D. 5N MEAN S.D. 6N MEAN S.D. 7N MEAN S.D. 20 0.304 0.017 19 0.263 0.012 19 0.235 0.015 19 0.216 0.010 14 0.192 0.014 15 0.198 0.017 15 0.191 0.015 20 3.094 0.242 19 2.649 0.125 20 2.394 0.126 20 2.243 0.137 14 1.920 0.132 15 2.017 0.176 15 1.873 0.152 20 10.291 0.471 20 8.941 0.331 19 7.794 0.27 6 20 7.238 0.335 15 6.399 0.350 15 6.660 0.231 15 6.343 0.186 16 0.319 0.040 16 0.273 0.042 16 0.269 0.027 16 0.252 0.015 12 0.226 0.012 13 0.236 0.030 12 0.247 0.051 17 3.395 0.601 13 3.028 0.512 16 2.861 0.393 13 2.570 0.170 8 2.262 0.188 12 2.662 0.337 6 2.348 0.140 18 10.378 1.400 16 8.867 1.027 19 8.142 0.679 20 8.219 0.997 15 7.464 0.685 15 7.675 0.703 14 7.325 0.627 Covance 6329-225 3M T-6314.1 PAGE: 1 004614 67 Table 9 Summary of Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS WEEK SEX: GROUP: DOSE: UNITS: 2 3 PPM -- MALE----3 30 PPM 4 100 PPM 8 9 10 11 12 13 1-13 N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. MEAN 12 0.178 0.010 IS 0.173 0.014 15 0.160 0.023 15 0.160 0.014 15 0.155 0.015 15 0.148 0.012 0.203 14 1.764 0.097 15 1.694 0.116 15 1.618 0.112 14 1.582 0.138 15 1.544 0.122 15 1.390 0.387 2.041 15 5.946 0.210 15 5.749 0.216 15 5.554 0.211 14 5.369 0.281 15 5.301 0.248 15 5.054 0.196 6.844 2 3 PPM --FEMALE--3 30 PPM 4 100 PPM 12 0.232 0.023 12 0.218 0.016 13 0.209 0.021 12 0.197 0.016 13 0.206 0.022 11 0.184 0.020 0.240 11 2.335 0.212 9 2.394 0.686 12 2.310 0.545 11 2.274 0.516 15 2.319 0.680 13 2.204 0.601 2.588 14 7.243 0.492 14 6.995 0.545 14 6.721 0.481 13 6.529 0.456 14 6.494 0.484 14 6.700 1.173 7.702 Covance S329-225 3M T-6314.1 PAGE: 2 004615 68 Table 10 Summary of Clinical Hematology Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE RBC H6B HCT MCV MCH MCHC PLT ppm MeFOS X10V*iL G/DL % FL PG X103/m L 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 8.18 .424 10 8.14 .427 10 8.24 .477 10 7.99 .303 10 16.2 .66 10 16.4 .47 10 16.3 .38 10 15.9 .71 10 47.0 2.04 10 47.5 1.70 10 47.1 1.64 10 46.0 1.71 10 57.4 1.97 10 58.4 1.77 10 57.2 1.93 10 57.6 1.86 10 19.8 .42 10 20.1 .73 10 19.8 .81 10 19.9 .76 10 34.5 .61 10 34.4 .51 10 34.7 .52 10 34.5 .45 10 1173 61.5 10 1151 136.0 10 1038 * 96.9 10 1081 112.7 10 Covance 6329-225 3M T-6314.1 004816 69 <1 \ DOSE ppm MeFOS WBC XIO'/VL Table 10 Summary of Clinical Hematology Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE , T-6314) IN RATS N-SEG LYMPH XIO'/m L X I O V k L MONO EOSIN BASO X10s/a<L x i o V m l x i o j/a<l N-SEG% LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% 0 MEAN 9.1 .6 7.9 .4 .1 .0 7 87 5 1 0 S.D. 1.96 .14 1.86 .15 .03 .00 2.1 2.2 1.3 .3 .3 N 10 10 10 10 10 10 10 10 10 10 10 3 MEAN 9.1 .6 8.0 .4 .1 .0 6 88 51 0 S.D. 1.74 .10 1.64 .20 .05 .00 1.6 3.5 1.9 .7 .0 N 10 10 10 10 10 10 10 10 10 10 10 30 MEAN 10.0 .5 9.0 .4 .1 .0 5 90 4 1 0 S.D. 2.48 .15 2.27 .13 .06 .04 1.4 1.8 1.1 .3 .4 N 10 10 10 10 10 10 10 10 10 10 10 100 MEAN 10.7 .9 9.0 .6 .1 .0 9 84 6 1 0 S.D. 3.51 .40 3.17 .20 .03 .05 3.6 4.2 1.3 .3 .5 N 10 10 10 10 10 10 10 10 10 10 10 004617 70 Table 10 Summary of Clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT ppm MeFOS X106/^L G/DL % FL PG % X I O V m L 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 7.70 .214 10 8.03 .488 10 7.98 .357 10 7.89 .326 10 15.7 .51 10 16.0 .61 10 16.0 .55 10 15.5 .54 10 45.4 1.31 10 46.1 2.08 10 45.8 1.91 10 44.7 1.62 10 59.1 1.45 10 20.4 .68 10 57.6 1.95 10 20.0 .76 10 57.4 1.48 10 20.0 .56 10 56.6 * 1.28 10 19.6 .34 10 34.5 .43 10 34.7 .64 10 35.0 .37 10 34.7 .71 10 1114 104 10 1178 82 10 1123 121 10 1058 217 10 Covance 6329-225 3M T-6314.1 004618 71 if DOSE ppm MeFOS Table 10 Summary of Clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 WBC XIO'/^L N-SEG LYMPH X10V//L X I O V m L MONO EOSIN BASO XIOV/^L X103/^L x i o V m l N-SEG% LYMPH% MONO% EOSIN BASO% 0 MEAN 6.3 .4 5.4 .3 .0 .0 7 87 5 1 0 S.D. 1.59 .29 1.32 .15 .05 .00 3.1 4.5 1.5 .3 N 10 10 10 10 10 10 10 10 10 10 10 3 MEAN 7.4 .5 6.5 .2 .1 .0 7 88 4 1 0 S.D. 2.21 .20 2.20 .12 .07 .00 3.2 4.0 1.6 .7 N 10 10 10 10 10 10 10 10 10 10 10 30 MEAN 7.3 .5 6.4 .3 .1 .0 S.D. 2.42 .19 2.24 .19 .05 .00 8 87 4 1 0 4.4 5.4 1.8 .3 N 10 10 10 10 10 10 10 10 10 10 10 100 MEAN 7.3 .5 6.4 .4 .1 .0 7 87 5 1 0 S.D. 2.09 .18 1.96 .27 .04 .03 3.7 4.5 2.3 .3 N 10 10 10 10 10 10 10 10 10 10 10 004619 i 72 Table 11 Summary of Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS RBC XloV/^L HGB G/DL HCT % MCV FL MCH MCHC PLT PG % X I O V ^ L MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 8.56 .463 10 8.42 .657 10 8.68 .535 10 8.25 .273 10 15.3 .71 10 15.3 .67 10 15.2 .56 10 14.6 .71 10 47.0 2.00 10 54.9 1.43 10 46.7 2.02 10 55.6 2.31 10 46.8 1.99 10 54.0 1.79 10 44.3 * 1.92 10 53.7 1.39 10 17.8 .40 10 18.2 .77 10 17.6 .82 10 17.7 .56 10 32.5 .40 10 32.7 .32 10 32.7 .71 10 33.0 .30 10 1122 119.5 10 1060 73.0 10 1000 140.3 10 1011 138.4 10 Covance 6329-225 3M T-6314.1 * jl u rP, i 004620 73 DOSE ppm MeFOS WBC XIOVmL Table 11 Summary of Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL p e r f l u o r o o c t a n e s u l f o n a m i d o ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH X I O V ^ L X103/m L MONO EOSIN BASO X103/m L X10'/m L X103/m L N-SEG% lymph% mono% E0SIN% Covance 6329-225 3M T-6314.1 BASO% 0 MEAN 6.9 .9 5.4 .5 .1 .0 13 78 72 0 S.D. .88 .28 .85 .14 .03 .00 4.0 4.3 1.9 .5 N 10 10 10 10 10 10 10 10 10 10 10 3 MEAN 6.7 1.0 5.1 .4 .1 .0 15 76 7 2 0 S.D. 1.48 .23 1.35 .18 .05 .00 3.4 5.6 2.8 .6 N 10 10 10 10 10 10 10 10 10 10 10 30 MEAN 7.7 .9 6.2 .4 .1 .0 13 eo 5 1 0 S.D. 2.68 .24 2.57 .14 .05 .00 4.7 5.6 2.1 .7 N 10 10 10 10 10 10 10 10 10 10 10 100 MEAN 7.2 1.1 5.6 .4 .1 .0 16 77 5 1 o S.D. 2.63 .35 2.13 .23 .05 .03 2.8 2.9 1.7 .4 N 10 10 10 10 10 10 10 10 10 10 10 004621 74 Table 11 Summary of Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT ppm MeFOS XIOVm U G/DL % FL PG % X I O V ^ L 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 7.76 .178 10 14.8 .45 10 8.07 .330 9 15.1 .75 9 8.09 * .343 10 15.1 .56 10 7.69 .289 10 14.2 .67 10 45.1 .95 10 46.1 1.97 9 46.2 1.77 10 43.1 * 1.91 10 58.1 1.13 10 57.1 1.70 9 57.2 1.57 10 56.1 * 1.26 10 19.0 .54 10 18.7 .63 9 18.7 .52 10 18.5 .49 10 32.7 .40 10 32.7 .49 9 32.7 .22 10 33.0 .37 10 1016 103.3 10 1073 108.7 9 980 97.8 10 1056 110.7 10 Covance 6329-225 3M T-6314.1 004622 75 DOSE ppm MeFOS WBC XlO'/piL Table 11 Summary of Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH X I O V k L X103/aiL MONO EOS IN BASO X103/i<L X103/m L X I O V ajL N-SEG% LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% 0 MEAN 4.0 .8 3.0 .2 .1 .0 19 74 52 0 S.D. .95 .47 .69 .12 .03 .00 8.5 8.8 2.8 .6 .4 N 10 10 10 10 10 10 10 10 10 10 10 3 MEAN 4.7 .7 3.7 .3 .1 .0 15 77 62 0 S.D. 1.27 .18 1.27 .05 .00 .00 5.3 6.4 1.3 .8 .0 N 9 9 9 9 9 9 9 9 9 9 .9 30 MEAN 5.7 1.0 4.4 .3 * .1 .0 17 76 5 1* 0 S.D. 1.08 .49 1.10 .10 .00 .03 7.6 8.0 1.7 .5 .3 N 10 10 10 10 10 10 10 10 10 10 10 100 MEAN 4.7 .6 3.8 .2 .1 .0 14 80 4 2 0 S.D. 2.03 .28 1.89 .09 .04 .00 7.0 8.4 1.8 .7 .3 N 10 10 10 10 10 10 10 10 10 10 10 C29fr00 76 DOSE ppm MeFOS Table 12 Summary of Clinical Chemistry Data Males Week 5 13-WEEK 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 Covance 6329-225 3M T-6314.1 TRIG MG/DL 0 MEAN 103 11 .6 6.9 4.7 2.2 S.D. 5.7 1.9 .07 .39 .23 .26 N 10 10 10 10 10 10 .2 .00 10 3 MEAN 114 11 .6 6.9 4.7 2.1 S.D. 14.1 1.4 .05 .23 .19 .14 N 10 10 10 10 10 10 .2 .00 10 30 MEAN 106 12 .6 6.6 4.7 2.0 * .2 S.D. 15.6 1.7 .03 .22 .14 .19 .03 N 10 10 10 10 10 10 10 100 MEAN 106 13 * .6 6.7 4.7 2.0 * .2 S.D. 17.5 1.6 .07 .29 .21 .18 .00 N 10 10 10 10 10 10 10 59 15.4 10 58 12.1 10 54 10.6 10 44 14.1 10 45 18.3 10 55 18.8 10 40 10.4 10 25 * 9.9 10 77 Table 12 Summary of Clinical Chemistry Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS 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 MEAN S.D. N MEAN S.D. N MEAN S.D. N 100 MEAN S.D. N 103 18.9 10 96 16.1 10 101 18.3 10 97 12.2 10 32 3.6 10 33 4.6 10 32 3.8 10 40 * 4.5 10 0 .5 10 10.9 .47 10 0 .5 10 10.8 .19 10 0 .7 10 10.5 .30 10 0 .3 10 10.6 .42 10 9.5 .61 10 9.8 .71 10 9.0 .78 10 9.0 1.02 10 147 1.3 10 147 1.6 10 148 1.2 10 147 2.5 10 6.2 .39 10 6.2 .42 10 6.1 .52 10 6.1 .46 10 105 2 10 105 1 10 106 1 10 105 2 10 Covance 6329-225 3M T-6314.1 78 DOSE ppm MeFOS Table 12 Summary of Clinical Chemistry Data Females Week 5 13-WEEK 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 Covance 6329-225 3M T-6314.1 TRIG MG/DL 0 MEAN 108 12 .7 7.4 5.3 2.1 .2 68 30 S.D. 9.2 1.2 .03 .31 .21 .24 .05 11.9 8.1 N 10 10 10 10 10 10 10 10 10 3 MEAN 100 12 .7 7.4 5.3 2.1 .2 69 28 S.D. 8.9 2.1 .04 .47 .39 .24 .00 12.0 8.9 N 10 10 10 10 10 10 10 10 10 30 MEAN 108 12 .7 7.3 5.3 1.9 .2 64 28 S.D. 10.0 1.5 .03 .34 .29 .19 .03 9.7 6.9 N 10 10 10 10 10 10 10 10 10 100 MEAN 95 * 14 .6 7.2 5.3 1.9 .2 53 26 S.D. 12.0 1.5 .07 .41 .28 .23 .00 21.7 9.3 N 10 10 10 10 10 10 10 10 10 4 tl f, 4 004626 79 Table 12 Summary of Clinical Chemistry Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS 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 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 99 15.3 10 93 7.5 10 93 14.0 10 93 16.0 10 28 4.8 10 27 4.9 10 28 3.5 10 30 5.8 10 0 .5 10 10.8 .52 10 0 .7 10 10.7 .40 10 1 1.1 10 10.8 .38 10 1 .8 10 10.6 .32 10 7.9 .65 10 8.2 .77 10 7.7 1.07 10 8.2 1.06 10 146 1.3 10 147 1.6 10 146 1.9 10 147 2.0 10 6.0 .31 10 5.8 .39 10 6.0 .60 10 5.8 .52 10 105 1.2 10 105 1.4 10 104 1.9 10 106 2.6 10 Covance 6329-225 3M T-6314.1 / P1 1 ti f, 004627 80 i 4 Table 12 Summary of Clinical Chemistry Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS PCOAO IU/G 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 12 3.6 5 13 2.1 5 8 4.3 5 9 1.9 5 Covance 6329-225 3M T-6314.1 1 s < ?9fr00 i 81 4 Table 12 Summary of Clinical Chemistry Data Females Week 5 13-WEEK DIETARY TOXICITY S T U D Y WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS PCOAO IU/G 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 7 2.5 5 5 2.9 5 7 3.3 5 11 2.7 5 Covance 6329-225 3M T-6314.1 629^00 82 i DOSE ppm MeFOS Table 13 Summary of Clinical Chemistry Data Males Week 14 13-WEEK 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 Covance 6329-225 3M T-6314.1 TRIG MG/DL 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 117 8.2 10 119 7.9 10 113 9.7 10 128 * 11.3 10 13 2.1 10 12 2.1 10 14 2.0 10 15 * 1.4 10 .8 .05 10 .7 .05 10 .8 .07 10 .7 .05 10 7.2 .34 10 7.0 .34 10 6.8 .57 10 7.2 .39 10 4.7 .24 10 4.7 .20 10 4.6 .35 10 5.2 * .29 10 2.5 .21 10 2.3 .21 10 2.1 * .30 10 2.0 * .26 10 .2 .05 10 .1 .05 10 .2 .05 10 .2 .05 10 69 15.2 10 57 17.4 10 49 * 15.1 10 26 * 12.1 10 59 22.2 10 56 23.3 10 36 * 10.3 10 17 * 5.2 10 i 004630 83 4 \ Table 13 Summary of Clinical Chemistry Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE DS AST/SGOT ALT/SGPT IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L MMOL/L CL MMOL/L MEAN S.D. N MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 89 18.4 10 86 9.7 10 91 16.7 10 91 14.3 10 38 5.1 10 41 6.4 10 38 7.0 10 60 * 21.6 10 2 1.3 10 10.7 .49 10 2 .7 10 10.6 .26 10 2 1.3 10 10.2 * .40 10 2 .7 10 10.4 .30 10 6.6 .65 10 6.5 .29 10 6.5 .58 10 6.9 .39 10 150 2.5 10 150 2.2 10 149 2.2 10 150 2.6 10 6.1 .31 10 6.1 .28 10 6.2 .36 10 6.4 .48 10 109 3 10 109 3 10 108 3 10 109 3 10 Covance 6329-225 3M T-6314.1 Tc9 f00 84 DOSE ppm MeFOS Table 13 Summary of Clinical Chemistry Data Females Week 14 13-WEEK 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 Covance 6329-225 3M T-6314.1 TRIG MG/DL 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 119 10.6 10 121 8.0 9 110 7.0 10 110 9.2 10 12 2.0 10 13 2.1 9 14 1.8 10 17 * 2.1 10 .8 .07 10 .8 .07 9 .8 .07 10 .8 .06 10 7.9 .50 10 7.7 .53 9 8.0 .42 10 8.2 .50 10 5.8 .41 10 5.6 .42 9 5.8 .24 10 6.0 .36 10 2.1 .31 10 2.1 .24 9 2.2 .28 10 2.1 .23 10 .2 .03 10 .2 * .05 9 .2 .03 10 .2 .00 10 73 12.6 10 69 9.4 9 70 9.9 10 51 * 17.7 10 43 16.8 10 38 21.5 9 36 12.7 10 25 4.2 10 2C95-00 85 Table 13 Summary of Clinical Chemistry Data Females Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS 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 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 84 10.1 10 107 32.6 9 128 126.7 10 80 9.3 10 34 5.7 10 43 20.7 9 64 105.5 10 36 6.1 10 2 1.2 10 3 1.2 9 3 1.7 10 3 1.0 10 11.0 .32 10 10.8 .41 9 11.0 .26 10 10.9 .27 10 4.8 .54 10 5.1 .93 9 5.6 .74 10 5.4 .90 10 150 1.9 10 150 3.6 9 151 2.6 10 150 2.7 10 5.7 .29 10 6.1 .70 9 6.2 .50 10 5.7 .43 10 111 2.7 10 111 3.3 9 109 2.6 10 109 3.0 10 Covance 6329-225 3M T-6314.1 004633 86 Table 13 Summary of Clinical Chemistry Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS PCOAO IU/G 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 10 2 15 9 2 15 9 2 15 15 8 15 Covance 6329-225 3M T-6314.1 004634 87 Table 13 Summary of Clinical Chemistry Data Females Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS PCOAO IU/G 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 7 2.5 15 7 2.9 14 9 2.8 15 20 * 6.7 15 Covance 6329-225 3M T-6314.1 004635 88 Table 14 Summary of Clinical Urinalysis Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS U VOL ML SP GR U PH 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 9.9 7.15 10 10.6 5.52 10 13.8 13.29 10 21.0 16.52 10 1.036 .0179 10 1.026 .0093 10 1.026 .0162 10 1.024 .0148 10 6.9 .32 10 6.9 .39 10 6.8 .42 10 6.6 .24 10 Covance 6329-225 3M T-6314.1 004636 89 Table 14 Summary of Clinical Urinalysis Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFOS U VOL ML SP GR U PH 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 17.0 14.13 10 11.4 10.11 9 16.7 14.62 10 15.7 12.05 10 1.016 .0112 10 1.020 .0102 9 1.016 .0084 10 1.019 .0113 10 6.7 .26 10 6.8 .44 9 6.8 .26 10 6.6 .21 10 Covance 6329-225 3M T-6314.1 004637 90 TABLE 15 Summary of Organ Weight Data Week 5 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 1 TABLE INCLUDES: SEX=ALL ;GROUP=ALL; WEEKS=ALL DEATH=1 ;SUBSET=T SEX DOSE GROUP M1 NUMBER IN GROUP: MEAN: STANDARD DEV: M2 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 335.2 45.6 5 10.7554 2.0653 5 340.9 18.5 5 10.9504 0.9661 ORGAN-TOBODY WT (%) 5 3.1879 0.2295 5 3.2077 0.1326 M3 NUMBER IN GROUP MEAN STANDARD DEV 5 347.4 26.9 5 13.1250 1.4559 5 3.7790 0.3232 LIVER SEX DOSE GROUP F1 NUMBER IN GROUP: MEAN: STANDARD DEV: F2 NUMBER IN GROUP MEAN STANDARD DEV F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT lg) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) 5 198.2 13.8 5 6.3023 0.5865 5 3.1778 0.1457 5 216.0 15.1 5 7.2592 0.4951 5 3.3620 0.0692 5 214.4 12.5 5 7.6187 0.7637 5 3.5493 0.2091 004638 91 TABLE 15 Summary of Organ Weight Data Week 5 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=1;SUBSET=T SEX DOSE GROUP M4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT <%) LIVER SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) NUMBER IN GROUP: MEAN: STANDARD DEV: 5 311.6 22.0 5 14.7069 1.1550 5 4.7214 0.1919 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 188.1 9.5 5 8.4256 0.4870 5 4.4836 0.2373 TABLE 16 Summary o Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 1 TABLE INCLUDES: SEX=ALL;GR0UP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ADRENAL SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 15 505.3 35.7 15 0.0562 0.0092 ORGAN-TOBODY WT (%) 15 0.0112 0.0020 ORGAN-TOBRAIN WT RATIO 15 0.0258 0.0044 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 0.0575 0.0083 15 0.0120 0.0020 15 0.0267 0.0038 F2 NUMBER IN GROUP MEAN STANDARD DEV M3 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 460.1* 31.8 15 0.0551 0.0088 15 0.0121 0.0022 15 0.0254 0.0040 F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 270.5 33.3 15 0.0709 0.0123 15 0.0265 0.0054 15 0.0365 0.0062 14 251.3 24.0 14 0.0675 0.0114 14 0.0268 0.0035 14 0.0343 0.0057 15 253.4 17.8 15 0.0700 0.0089 15 0.0278 0.0040 15 0.0348 0.0050 004640 93 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT igi ORGAN WEIGHT <g> ADRENAL ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT <%> ORGAN-TOBRAIN WT RATIO NUMBER IN GROUP: MEAN: STANDARD DEV: IS 445.8* 24.4 15 0.0560 0.0073 15 0.0126 0.0014 15 0.0259 0.0039 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 0.0672 0.0113 15 0.0293 0.0047 15 0.0330 0.0052 004641 94 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 3 TABLE INCLUDES: SEX=ALL :GROUP=ALL ;WEEKS=ALL DEATH=T;SUBSET=ALL BRAIN SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT lg) ORGAN WEIGHT (g 15 505.3 35.7 15 2.1771 0.0642 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 0.4326 0.0283 15 1.0000 0.0000 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 2.1519 0.0910 15 0.4480 0.0354 15 1.0000 0.0000 F2 NUMBER IN GROUP MEAN STANDARD DEV M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 15 2.1680 0.07 68 15 0.4731* 0.0323 15 1.0000 0.0000 F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g> ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 270.5 33.3 15 1.9434 0.1049 15 0.7256 0.0712 15 1.0000 0.0000 14 251.3 24.0 14 1.9678 0.0694 14 0.7891* 0.0733 14 1.0000 0.0000 15 253.4 17.8 15 2.0183 0.0826 15 0.7995* 0.0538 15 1.0000 0.0000 004642 i 4 jj TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 4 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL BRAIN SEX DOSE GROUP M4 TERMINAL BODY WT (g) ORGAN WEIGHT (g> ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TO- BRAIN WT RATIO NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 2.1678 0.0884 15 0.4878* 0.0360 15 1.0000 0.0000 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 2.0372* 0.1113 15 0.8910* 0.0599 15 1.0000 0.0000 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL fN-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 5 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 15 505.3 35.7 15 3.8199 0.4337 M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 3.7300 0.3858 M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 15 3.8085 0.3063 KIDNEY ORGAN-TOBODY WT (%> 15 0.7549 0.0520 ORGAN-TOBRAIN WT RATIO 15 1.7543 0.1893 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV 15 0.7744 0.0762 15 1.7358 0.1924 F2 NUMBER IN GROUP MEAN STANDARD DEV 15 0.8308* 0.0819 15 1.7609 0.1761 F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 270.5 33.3 15 2.1241 0.2283 15 0.7893 0.0711 15 1.0931 0.1021 14 251.3 24.0 14 2.1259 0.2488 14 0.8469 0.0664 14 1.0809 0.1239 15 253.4 17.8 15 2.2559 0.1509 15 0.8936* 0.0771 15 1.1190 0.0819 004644 *rr TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 6 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT (g> ORGAN WEIGHT (g) KIDNEY ORGAN-TOBODY WT (%> ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 4.1850* 0.4155 15 0.9389* 0.0787 15 1.9357* 0.2325 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 2.1983 0.2606 15 0.9576* 0.0797 15 1.0773 0.0948 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 7 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LIVER SEX DOSE GROUP M 1' NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT <g> ORGAN WEIGHT (g) 15 505.3 35.7 15 14.5017 1.6903 ORGAN-TOBODY WT (%) 15 2.8663 0.2214 ORGAN-TOBRAIN WT RATIO 15 6.6577 0.7163 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 14.3465 1.3494 15 2.9803 0.2896 15 6.6774 0.6795 F2 NUMBER IN GROUP MEAN STANDARD DEV M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 15 15.9014 1.5170 15 3.4572* 0.2312 15 7.3423* 0.7472 F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 270.5 33.3 15 8.0512 1.3405 15 2.9775 0.3423 15 4.1397 0.6146 14 251.3 24.0 14 7.8673 0.9141 14 3.1298 0.2035 14 3.9983 0.4464 15 253.4 17.8 15 9.2512* 0.7652 15 3.6610* 0.3281 15 4.5878 0.3853 004646 99 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 8 TABLE INCLUDES: SEX=ALL;GR0UP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT (9) ORGAN WEIGHT (g) LIVER ORGAN-TOBODY WT (%) ORGAN-TO- BRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 24.5652* 2.7276 15 5.5083* 0.4975 15 11.3342* 1.1828 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 12.2021* 1.4877 15 5.3304* 0.6283 15 5.9827* 0.5773 004647 100 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL {N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 9 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL OVARY SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 15 505.3 35.7 ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 F2 NUMBER IN GROUP MEAN STANDARD DEV M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 270.5 33.3 15 0.1280 0.0205 15 0.0480 0.0097 15 0.0658 0.0096 14 251.3 24.0 14 0.1225 0.0227 14 0.0489 0.0081 14 0.0624 0.0117 15 253.4 17.8 15 0.1221 0.0215 15 0.0486 0.0109 15 0.0605 0.0109 004648 101 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 10 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL OVARY SEX DOSE GROUP M4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 0.1206 0.0238 15 0.0527 0.0099 15 0.0592 0.0107 1 6 fr9fr00 102 < jf TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 11 TABLE INCLUDES: SEX=ALL ;GR0UP=ALL ;WEEKS=ALL DEATH=T;SUBSET=ALL SPLEEN SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g> ORGAN WEIGHT (g) 15 505.3 35.7 15 0.8041 0.0904 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 0.1592 0.0149 15 0.3691 0.0371 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 0.7666 0.1431 15 0.1597 0.0332 15 0.3558 0.0604 F2 NUMBER IN GROUP MEAN STANDARD DEV M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 15 0.7341 0.0802 15 0.1602 0.0203 15 0.3390 0.0390 F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 270.5 33.3 15 0.5153 0.1324 15 0.1907 0.0408 15 0.2649 0.0644 14 251.3 24.0 14 0.5235 0.0643 14 0.2090 0.0239 14 0.2658 0.0290 15 253.4 17.8 15 0.5166 0.0506 15 0.2049 0.0251 15 0.2568 0.0306 04650 i 103 4 |l TABLE 16 Summary of Organ Weight Data week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 12 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT (g) ORGAN WEIGHT (g> SPLEEN ORGAN-TOBODY WT (%> ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 0.6707* 0.1266 15 0.1501 0.0251 15 0.3101* 0.0620 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 0.4675 0.0678 IS 0.2037 0.0232 15 0.2294 0.0296 oo en TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 13 TABLE INCLUDES: SEX=ALL;GR0UP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 15 505.3 35.7 15 3.3907 0.2211 M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 3.3852 0.3024 M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 15 3.4481 0.3067 TESTIS ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 0.6733 0.0559 15 1.5579 0.0976 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV 15 0.7028 0.0565 15 1.5752 0.1496 F2 NUMBER IN GROUP MEAN STANDARD DEV 15 0.7535* 0.0874 15 1.5922 0.1509 F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 270.5 33.3 14 251.3 24.0 15 253.4 17.8 004652 105 I TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T - 6314.1 PAGE: 14 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T; SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT (g> ORGAN WEIGHT (g) TESTIS ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT !%) ORGAN-TOBRAIN WT RATIO NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 3.4789 0.2974 15 0.7824* 0.0756 15 1.6042 0.1126 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8 22.7 004653 106 I TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 15 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL THYMUS SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g> ORGAN WEIGHT (g) 15 505.3 35.7 15 0.3454 0.0847 ORGAN-TOBODY WT (%) 15 0.0684 0.0160 ORGAN-TOBRAIN WT RATIO 15 0.1586 0.0383 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 0.3117 0.0630 15 0.0651 0.0152 15 0.1451 0.0301 F2 NUMBER IN GROUP MEAN STANDARD DEV M3 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 460.1* 31.8 15 0.2725* 0.0678 15 0.0592 0.0147 15 0.1260* 0.0324 F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT 1%) ORGAN-TOBRAIN WT RATIO 15 270.5 33.3 15 0.2814 0.0627 15 0.1053 0.0259 15 0.1451 0.0330 14 251.3 24.0 14 0.2951 0.0491 14 0.1176 0.0179 14 0.1499 0.0236 15 253.4 17.8 15 0.2978 0.0627 15 0.1174 0.0225 15 0.1476 0.0310 0046S4 107 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 16 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) THYMUS ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 0.2610* 0.0515 15 0.0586 0.0115 15 0.1206* 0.0246 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 0.2654 0.0525 15 0.1152 0.0190 15 0.1300 0.0229 004655 108 I TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 17 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T; SUBSET=ALL SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 15 505.3 35.7 15 0.0255 0.0063 M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 0.0254 0.0078 M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 15 0.0244 0.0048 THYROID/PARATHYR ORGAN-TOBODY WT (%) 15 0.0051 0.0013 ORGAN-TOBRAIN WT RATIO 15 0.0117 0.0029 SEX DOSE GROUP F1 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 0.0053 0.0017 15 0.0118 0.0034 F2 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 0.0053 0.0010 15 0.0112 0.0019 F3 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT <g> 15 270.5 33.3 15 0.0203 0.0062 14 251.3 24.0 14 0.0180 0.0066 15 253.4 17.8 15 0.0190 0.0046 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 0.0075 0.0024 15 0.0104 0.0029 14 0.0072 0.0027 14 0.0092 0.0034 15 0.0075 0.0019 15 0.0094 0.0024 o o o C/l TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 18 TABLE INCLUDES: SEX=ALL;GR0UP=ALL;WEEKS=ALL DEATH=T; SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) THYROID/PARATHYR ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT <%) ORGAN-TOBRAIN WT RATIO NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 0.0252 0.0033 15 0.0057 0.0009 15 0.0117 0.0017 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 0.0203 0.0052 15 0.0088 0.0020 15 0.0100 0.0024 i 004657 110 I ( if TABLE 17 Incidence of Macroscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK 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;SUBSET=ALL -- SEX: N UM BE R -O F -AN IMA LS --- MALE- -- -- -- -- FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE -------------------------------------- -- ** TOP OF LIST ** GENERAL COMMENT (GC) ............... NUMBER: 20 20 20 20 -=- -=- -=- -=- 20 20 20 20 20 20 20 20 -=- -=- -=- 20 20 20 20 BONE MARROW SMEAR TAKEN MALOCCLUSION NO MACROSCOPIC LESIONS TAIL - BENT/MISSING STAINS-PERINEUM/PERI ANAL 15 15 15 15 15 14 15 15 14220110 8 7 7 6 13 9 11 8 00000001 00100000 LIVER (LI) ......................... 20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 20 20 16 20 20 20 19 LIGHT FOCUS(I)/AREA(S) LARGE DIFFUSELY DARK 00010000 00030000 00020001 KIDNEY (KD) ........................ .................. NUMBER EXAMINED: 20 20 20 20 20 20 20 20 NOT REMARKABLE: 19 19 20 18 20 20 20 20 LARGE PELVIS(ES) GRANULAR MATERIAL 11020000 01000000 SPLEEN (SP) ........................ 20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 20 20 20 19 20 20 20 ADHESION(S) 00001000 F F E C T E D -- 004658 111 6S900 1 1IIoto TABLE 17 Incidence of Macroscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK 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;SUBSET=ALL ORGAN AND KEYWORD(S) OR PHRASE N UMB ER -O F -AN IMA LS SEX: --- MALE--- -- -- --FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 F F E C T E D -- THYMUS (TH) ....................... ................... NUMBER EXAMINED: 20 20 20 20 20 20 20 20 NOT REMARKABLE: 17 18 16 18 20 19 19 20 RED FOCUS(I)/AREA(S) DIFFUSELY RED MOTTLED 2 1 3 1 0010 0 11 1 0 100 10 0 0 0000 PITUITARY (PI) .................... ................... NUMBER EXAMINED: 20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 20 20 20 19 20 20 20 LARGE 00 0 0 1000 STOMACH, GL (ST) ................... 20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 18 20 18 20 20 19 17 DARK FOCUS(I)/AREA(S) LIGHT FOCUS(I)/AREA(S) 0 10 2 0003 01 0 0 0010 LN, MANDIBULAR (MN) ............... ................... NUMBER EXAMINED: 20 20 20 20 20 20 20 20 NOT REMARKABLE: 16 18 15 16 20 20 17 20 DIFFUSELY RED MOTTLED 3243 0020 101 1 0010 112 TABLE 17 Incidence of Macroscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 3 TABLE INCLUDES: SEX=ALLiGROUP=ALL;WEEKS=ALL DEATH=ALL;SUBSET=ALL ORGAN AND KEYWORD(S) OR PHRASE UTERUS (UT) ....................... LUMEN FILLED WITH FLUID OVARY (OV) ........................ DIFFUSELY RED TAIL (TI) ......................... LACERATION(S) ** END OF L IS T ** -- N U M B E R - O F - A N I M A L S - A F F E C T E D ---- SEX: --------------MALE-------------- ------------FEMALE GROUP: -1- -2- -3- -4- -1- -2- -3- -4NUMBER: 20 20 20 20 20 20 20 20 0 0 0 0 20 20 20 20 NOT REMARKABLE: 0 0 0 0 19 17 19 19 00001311 0 0 0 0 20 20 20 20 NOT REMARKABLE: 0 0 0 0 20 20 19 18 00000012 20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 20 20 20 20 19 20 20 00000100 004660 113 TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK 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=ALL ORGAN AND FINDING DESCRIPTION ** TOP OF LIST ** BONE, FEMUR (FE) .......... MARROW, FEMUR (FM) MARROW, STERNUM (SE) BONE, STERNUM (SB) EYE (EY) ......................... BRAIN (BR) ....................... --INFILTRATE, LYMPHOHISTIOCYTIC SPINAL CORD (SC) ................. -- SEX: N UM BER-0 F -AN IMA LS --- MALE--- -- -- -- FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 -- -=- -=- "SS-- "=- -=- -=" -=" -=- NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 14 00000001 NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 PAGE: 1 t 995'00 114 i TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK 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 ORGAN AND FINDING DESCRIPTION -- N U M B E R - O F - A N I M A L S SEX: ------- MALE------- ------FEMALE 1 u> GROUP: -1- -2- -4- -1- -2- -3- NUMBER: 20 20 20 20 20 20 A F F E C T E D -- 11NJ 1 1O 1 1O 1 11 to LUNG (LU) ..................................... ....... NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 6 0 0 7 12 1 0 12 --HEMORRHAGE -- INFILTRATE, MACROPHAGE, ALVEOLAR --INFLAMMATION, SUBACUTE --MINERALIZATION, VASCULAR 10000000 40051002 10000001 50032000 TRACHEA (TR) .................................. 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 ESOPHAGUS (ES) ................... 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 LIVER (LI) ........................................ 15 15 15 15 15 15 15 15 NOT REMARKABLE: 5 0 1 0 5 4 2 0 --FIBROSIS, CAPSULAR --HYPERTROPHY, HEPATOCELLULAR, DIFFUSE -- HYPERTROPHY, HEPATOCELLULAR, CENTRI LOBULAR --INFILTRATE, LYMPHOHISTIOCYTIC -- NECROSIS, COAGULATIVE -- NECROSIS, INDIVIDUAL HEPATOCYTE --PIGMENT, HEPATOCELLULAR -- VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL -- VACUOLATION, HEPATOCELLULAR, DIFFUSE ** CONTINUED ON NEXT PAGE ** 0 010 1 000 00000001 0 0 14 15 0 0 7 14 10 15 13 10 10 11 12 9 00030010 69563645 0 002 0 007 0 02 7 0 002 0022 0000 004662 115 TABLE 18 Incidence of Microscopic Observations C o v a n c e 6329-225 3M T-6314.1 13-WEEK 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 ** FROM PREVIOUS PAGE ** LIVER (LI) ........................................ --VACUOLATION, HEPATOCELLULAR, PERIPORTAL KIDNEY (KD) ....................................... --BASOPHILIC TUBULES, CORTEX -- DILATATION, PELVIC --INFLAMMATION, CHRONIC --MINERALIZATION, TUBULAR --THICKENING, BASEMENT MEMBRANE HEART (HT) ........................................ --DEGENERATION/NECROSIS MUSCLE, SKELETAL (SM) ............................. NERVE, SCIATIC (SN) ............................... NU M B ER -0 F -A N IMA LS SEX: --- MALE--- -- -- -FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 F F E C T E D -- 15 15 15 15 15 15 15 15 NOT REMARKABLE: 5 0 1 0 5 4 2 0 00102300 15 1 0 15 15 1 0 15 NOT REMARKABLE: 11 0 0 12 14 1 0 12 20000000 11020000 00000001 10011002 10000000 15 0 0 15 15 1 0 15 NOT REMARKABLE: 12 0 0 12 15 1 0 14 30030001 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 p 99fr0 1 1 1 1 ( 1 1 t 1 11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 i 1 1 1 1 04664 TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK 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 -- SEX: N UM BER -0F-AN IMA LS --- MALE-- ----- -- --FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER; 20 20 20 20 20 20 20 20 -------------- ------- -SS- -=- -=- -=- -S- -=- "=" -= - SPLEEN (SP) ....................................... .... NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 14 1 0 15 --INFLAMMATION, CHRONIC, CAPSULAR 00001000 THYMUS (TH) ....................................... ___ NUMBER EXAMINED: 15 2 4 15 15 2 1 15 NOT REMARKABLE: 9 0 0 6 11 1 0 10 --HEMORRHAGE --INVOLUTION LN, MESENTERIC (MS) ............................... 62494114 00111102 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 13 15 1 0 15 --HEMORRHAGE 00020000 THYROID (TY) ...................................... 15 0 0 15 15 1 0 15 NOT REMARKABLE: 4 0 0 8 6 1 0 9 --CYST, ULTIMOBRANCHIAL --ECTOPIC THYMUS -- INFILTRATE, LYMPHOHISTIOCYTIC --ONE EXAMINED 90079006 10000000 10000000 10000001 PARATHYROID (PT) .................................. 15 0 0 15 15 1 0 15 NOT REMARKABLE; 13 0 0 15 15 1 0 14 --CYST ** CONTINUED ON NEXT PAGE ** 10000000 F F E C T E D -- 117 TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 5 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION ** FROM PREVIOUS PAGE ** PARATHYROID (PT) ........................ --ONE EXAMINED ADRENAL, CORTEX (AC) .................... --INFILTRATE, LYMPHOHISTIOCYTIC ADRENAL, MEDULLA (MA) ................... AORTA (AO) ............................... PITUITARY (PI) .......................... --CYST --HYPERPLASIA STOMACH, GL (ST) ........................ --EROSION N UM BER -0 F -AN IMA LS SEX: --- MALE- -- -- -- ---FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 F F E C T E D -- 15 0 0 15 15 1 0 15 NOT REMARKABLE: 13 0 0 15 15 1 0 14 10000001 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 14 15 1 0 15 00010000 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 15 NOT REMARKABLE: 14 1 0 14 NOT REMARKABLE: 14 0 0 0 15 15 0 0 14 14 0010 0001 2 15 15 15 1 15 13 15 1020 1 0 15 1 0 15 000 000 1 15 15 1 15 12 003 00466S 118 TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO 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 FINDING DESCRIPTION -- N UMBER-O F -AN IMA LS SEX: --- MAL E - - -- -- ---FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 F F E C T E D -- STOMACH, NONGL (SU) ........................ 14 NOT REMARKABLE: 14 0 15 15 15 0 15 15 15 1 15 15 1 15 15 PANCREAS (PA) ............................... 15 0 0 15 15 1 0 15 NOT REMARKABLE: 11 0 0 13 14 1 0 13 --ATROPHY, ACINAR --INFILTRATE, LYMPHOHISTIOCYTIC --INFLAMMATION, CHRONIC-ACTIVE --PIGMENT, BROWN 00011001 2 0 00 1 002 10020000 20020000 DUODENUM (DU) ............................... ......... NUMBER EXAMINED: 14 0 0 15 15 1 0 15 NOT REMARKABLE: 14 0 0 15 15 1 0 15 JEJUNUM (JE) ................................ 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 ILEUM (IL) .................................. 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 CECUM (CE) .................................. 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 004666 119 TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N--MEFOSE, T-6314) IN RATS PAGE: 7 TABLE INCLUDES: SEX=ALL;GR0UP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION SEX: N UM BER -O F -AN IMA LS --- MALE---- -- ------FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 F F E C T E D -- COLON (CO) ....................... .................... NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 RECTUM (RE) ...................... .................... NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 13 0 0 15 14 1 0 15 --PARASITISM 20001000 LN, MANDIBULAR (MN) .............. .................... NUMBER EXAMINED: 15 2 5 15 15 1 3 15 NOT REMARKABLE: 11 0 0 7 12 1 0 14 --HEMORRHAGE --HYPERPLASIA, PLASMACYTIC 42582031 00001000 SALIV GL, MANDIB (SG) ............ 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 HARDERIAN GLAND (HG) ............. 15 0 0 15 15 1 0 15 NOT REMARKABLE: 14 0 0 13 15 1 0 14 --INFILTRATE, LYMPHOHISTIOCYTIC 10020001 AUDITORY SEB GL (AS) ............. .................... NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 12 11 1 0 13 --ONE EXAMINED 00034002 004667 120 TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK 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 N U M B E R - <D F - A N I M A L S SEX: --- MALE---- -- -- ---FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 SKIN (SK) ........................ 15 0 0 15 15 1 0 15 NOT REMARKABLE: 14 0 0 15 15 1 0 15 -- EXUDATE, EPIDERMAL SURFACE --INFLAMMATION, SUBACUTE 100 0 0000 10000000 MAMMARY, FEMALE (MF) ............. .................... NUMBER EXAMINED: 0 0 0 0 15 1 0 15 NOT REMARKABLE: 0 0 0 0 15 1 0 15 URINARY BLADDER (UB) ............. .................... NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 13 15 1 0 15 --INFILTRATE, LYMPHOHISTIOCYTIC 0062 0000 UTERUS (UT) ...................... 0 0 0 0 15 4 1 15 NOT REMARKABLE: 0 0 0 0 14 1 1 10 --DILATATION 00001305 CERVIX (CV) ...................... .................... NUMBER EXAMINED: 0 0 0 0 15 1 0 15 NOT REMARKABLE: 0 0 0 0 15 1 0 15 OVARY (OV) ....................... 0 0 0 0 15 1 1 15 NOT REMARKABLE: 0 0 0 0 15 1 1 15 F F E C T E D -- 004668 121 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION VAGINA (VA) PROSTATE (PR) .................... --INFILTRATE, LYMPHOHISTIOCYTIC --INFLAMMATION, CHRONIC-ACTIVE SEMINAL VESICLES (SV) ............ TESTIS (TE) EPIDIDYMIDES (EP) TAIL (TI) --HEMORRHAGE --ULCERATION ** END OF LIST ** TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL NAMIDO ETHANOL (N--MEFOSE, T-6314) IN RATS PAGE: 9 -- N U M B E R -OF- A N I M A SEX: --- MALE---- -- -- - F E M A L E - - GROUP: -1- -2- -3- --4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 F F E C T E D -- NUMBER EXAMINED: 0 0 0 0 15 1 0 15 NOT REMARKABLE: 0 0 0 0 15 1 0 15 oo oo oo NUMBER EXAMINED: 15 0 0 15 0 0 0 NOT REMARKABLE: 3 0 0 9 0 0 0 12 0 0 6 0 0 0 0001000 NUMBER EXAMINED: 15 0 0 15 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 NUMBER EXAMINED: 15 0 0 15 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 NUMBER EXAMINED: 15 0 0 15 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 NUMBER EXAMINED: 0 0 0 0 0 1 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0000010 0000010 G 9 9 fr0 0 122 TABLE 19 Incidence of Severity of Selected Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK 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=T -- NUM BER -O F -AN IMA LS SEX: --- MALE-- -- -- ---FEMALE-- GROUP : -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 20 20 20 20 20 20 20 20 ** TOP OF LIST ** LIVER (LI) ......................................... ... NUMBER EXAMINED: 15 15 15 15 15 15 15 15 -- FIBROSIS, CAPSULAR - > 15 15 14 15 14 15 15 15 1> 0 0 1 0 1 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.0 0.1 0.0 0.0 0.0 --HYPERTROPHY, HEPATOCELLULAR, DIFFUSE - > 15 15 15 15 15 15 15 14 2> 0 0 0 0 0 0 0 1 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.1 --HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR - > 15 15 1 0 15 15 8 1 1> 0 0 11 0 0 0 7 0 2> 0 0 3 1 0 0 0 7 3> 0 0 0 14 0 0 0 7 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 1.1 2.9 0.0 0.0 0.5 2.3 --INFILTRATE, LYMPHOHISTIOCYTIC ** CONTINUED ON NEXT PAGE ** -> 5 0 2 5 5 4 3 6 1> 10 14 13 10 10 11 12 9 2> 0 1 0 0 0 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.7 1.1 0.9 0.7 0.7 0.7 0.8 0.6 F F E C T E D -- 004670 123 TABLE 19 Incidence of Severity of Selected Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK 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=T -- SEX: N U M B E R - 0 F - ANI M A L S --- MALE-- -- -- -- -FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 20 20 20 20 20 20 20 20 ** FROM PREVIOUS PAGE ** LIVER (LI) ................ --NECROSIS, COAGULATIVE NUMBER EXAMINED: 15 15 15 15 15 15 15 15 -> 15 15 15 12 15 15 14 15 1> 0 0 0 2 0 0 1 0 2> 0 0 0 1 0 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.0 0.3 0.0 0.0 0.1 0.0 --NECROSIS, INDIVIDUAL HEPATOCYTE -> 9 6 10 9 12 9 11 10 1> 6 9 5 5 3 6 4 5 2> 0 0 0 1 0 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.4 0.6 0.3 0.5 0.2 0.4 0.3 0.3 -- PIGMENT, HEPATOCELLULAR -> 15 15 15 13 15 15 15 8 1> 0 0 0 2 0 0 0 7 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.5 --VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZ;Oo Nn Aa Ll ** CONTINUED ON NEXT PAGE ** -> 15 15 13 8 15 15 15 13 1> 0 0 2 5 0 0 0 2 2> 0 0 0 2 0 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.6 0.0 0.0 0.0 0.1 F F E C T E D -- 124 TABLE 19 Incidence of Severity of Selected Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK 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 ** FROM PREVIOUS PAGE ** LIVER (LI) ...................... --VACUOLATION, HEPATOCELLULAR, DIFFUSE --VACUOLATION, HEPATOCELLULAR, PERIPORTAL STOMACH, GL (ST) ................ --EROSION ** END OF LIST ** -- SEX: NUMBER-OF -AN IMA LS --- MALE- -- -- -- -- FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 EXAMINED: 15 15 15 15 15 15 15 15 -> 15 15 13 13 15 15 15 15 1> 0 0 2 0 0 0 0 0 2> 0 0 0 2 0 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.3 0.0 0.0 0.0 0.0 -> 15 15 14 15 13 12 15 15 1> 0 0 1 0 2 3 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.0 0.1 0.2 0.0 0.0 EXAMINED: 14 2 15 15 15 1 15 15 -> 14 1 15 13 15 1 15 12 1> 0 0 0 1 0 0 0 2 2> 0 1 0 1 0 0 0 1 TL> 14 2 15 15 15 1 15 15 MN> 0.0 1.0 0.0 0.2 0.0 0.0 0.0 0.3 PAGE: 3 004672 125 APPENDIX 1 Protocol Deviations Protocol Protocol Amendment No. 1 Protocol Amendment No. 2 Protocol Amendment No. 3 Covance 6329-225 3M T-6314.1 004673 Protocol Deviations Covance 6329-225 3M T-6314.1 Protocol. Housing. Diet. " Certified Rodent Diet #5002, meal (PMI Nutrition International) ad libitum, unless otherwise specified." A ctual Procedure. The animals were given Teklad 8728C pelleted food from August 17, 1998 to August 23, 1998. Protocol. Dose Preparation. Retention Samples. "During the in-life phase, samples (approximately 100 g) will be taken from each dose preparation sampled for dose analyses and stored at room temperature. Unless used for analyses, these samples will be discarded approximately 1 month after completion o f the in-life phase." A ctual Procedure. Retention samples were discarded after approximately 1 month o f the completion o f the in-life phase. Protocol. Observation o f 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." A ctual Procedure. On Days 16 through 30, the a.m. and p.m. mortality and moribundity checks were not documented. Protocol. Termination. Scheduled Sacrifices. "After at least 4 weeks of treatment, five animals/sex/group will be fasted overnight, bled for serum samples, anesthetized with carbon dioxide, weighed, and exsanguinated." A ctual Procedure. Fasting o f animals at the Week 5 scheduled sacrifice was not documented. Protocol. Experimental Design. Postmortem Procedures. "The following tissues (when present) or representative samples will be collected from each animal and preserved in 10% phosphate-buffered formalin, unless otherwise specified." T rr 004674 Covance 6329-225 3M T-6314.1 A ctual Procedure. 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. These deviations are not expected to have affected the results o f the study. -m - 004675 C O V A IT' THE DEVELOPMENT SERVICES COMPANY Sponsor: 3M St. Paul, Minnesota PROTOCOL Study Title: 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Date: August 27, 1998 Performing Laboratory: Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Laboratory Study Identification: Proposal No. 90545D Covance 6329-225 Sponsor Project Identification: 3M T-6314.1 t29- 04676 Covance 6329-225 __________ Page 2 Study 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Purpose To assess the toxicity of the test material when administered in the diet to rats for at least 13 weeks Sponsor 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Study M onitor Andrew M. Seacat, PhD 3M Toxicology Services Telephone No.: 651.575.3161 Facsimile No.: 651.733.1773 Alternate Study M onitor Marvin T. Case, DVM, PhD 3M Toxicology Services Telephone No.: 651.733.5180 Facsimile No.: 651.733.1773 Study Location Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Mailing Address: PO Box 7545 Madison, Wisconsin 53707-7545 130 004677 Study Director Peter J. Thomford, PhD Covance Laboratories Inc. Telephone No.: 608.241.7207 Facsimile No.: 608.242.2736 Covance 6329-225 __________ Page 3 Toxicologist Thomas E. Ryan, BS Covance Laboratories Inc. Proposed Study Timetable In-Life Start Date: September 1,1998 In-Life End Date: December 3, 1998 Audited Draft Report Date: May 26, 1998 Regulatory Compliance This study will be 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. Animal C are and Use Statem ent All procedures in this protocol are in compliance with the Animal Welfare Act Regulations, 9 CFR 1-4. In the opinion o f the Sponsor and study director, the study does not unnecessarily duplicate any previous work. Quality Assurance The protocol, study conduct, and final report will be audited by the Covance Quality Assurance Unit (QAU). The proliferation cell nuclear antigen (PCNA) evaluation, data, and report will be audited by the QAU o f Pathology Associates International. Liver and serum analyses, data, and report will be audited by the QAU o f 3M Environmental Technology and Safety Services. T94- 004678 Test M aterial Covance 6329-225 __________ Page 4 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 of the Sponsor Storage Conditions At room temperature C h aracteristics Information on synthesis methods, composition, or other characteristics that define the test material is on file with the Sponsor. Reserve (Archive) Samples A reserve sample (approximately 5 g) o f each lot will be taken and stored at room temperature. These samples will be transferred to the Sponsor after completion o f the in-life phase. Disposition of Test M aterial 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.: 651.733.1773 004679 A nim als Covance 6329-225 _________ Page 5 Species Rat Strain Crl:CD*(SD) IGS BR Source Charles River Laboratories, Inc., Portage, Michigan Age at Initiation of Treatm ent Preferably less than 6 weeks o f age but not more than 8 weeks o f age W eight at Initiation of Treatm ent 100 to 300 g N um ber and Sex 80 males and 80 females Identification Implantable microchip identification device H usbandry Housing Individual (may be group-housed during acclimation). Animals will be housed in suspended, stainless steel cages. Diet Certified Rodent Diet #5002, meal (PMI Nutrition International) ad libitum, unless otherwise specified. The diet is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Specified nutrient and contaminant analyses are on file at Covance-Madison. 004680 Covance 6329-225 __________ Page 6 Water Ad 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 with this study. Environment 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. The light/dark cycle may be interrupted to accommodate in-life procedures. Acclimation At least 1 week Randomization Selection o f animals for the study will be based on clinical observations, ophthalmic examinations, and other data as appropriate. Animals will be assigned to treatment groups using a computerized blocking procedure designed to achieve body weight balance with respect to treatment groups. At the time of randomization, the weight variation of the animals of each sex used will not exceed 2 standard deviations o f the mean weight, and the mean body weight for each group o f each sex will not be statistically different at the 5.0% probability level. Justification Rats historically have been used in safety evaluation studies and are recommended by appropriate regulatory agencies. m - 004681 Covance 6329-225 __________ Page 7 G roup Designations and D ietary Levels Number o f Animals Dietary Levels Group Male Female (ppm MeFOS)* 1 (Control)b 20 20 0 2 (Low) 20 20 3 3 (Mid) 20 20 30 4 (High) 20 20 100 a Dose levels are expressed as ppm of MeFOS. b The control animals will receive the basal diet only. Dosing Procedures M ethod of Administration Dietary, 7 days/week for at least 13 weeks. Treatment will continue through the day before necropsy. Reason for Dosing Route The potential route o f exposure in humans is oral. Dose Preparation All dose preparations will be mixed according to the study-specific mixing procedure developed by Covance. Dose concentrations will be based on the MeFOS content as supplied. All dose preparations will be stored at room temperature. Before initiation of treatment, dose preparations o f 1 ppm, 3 ppm, 30 ppm, 100 ppm and 500 ppm will be mixed. Dose preparations will be mixed at least once every 4 weeks during the in-life phase. Retention Samples During the in-life phase, samples (approximately 100 g) will be taken from each dose preparation sampled for dose analyses and stored at room temperature. Unless used for analyses, these samples will be discarded approximately 1 month after completion o f the in-life phase. T35* 004682 Covance 6329-225 __________ Page 8 Dose Analyses By Covance, using a method supplied by the Sponsor and validated by Covance Homogeneity Homogeneity will be determined for 3-ppm, 30-ppm, and 100-ppm dose preparations once pretest. One sample (approximately 100 g) each from the top, middle, and bottom of 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 within 7 days after mixing. Homogeneity analysis will be repeated if batch size changes by more than 30%. Stability Four samples (approximately 100 g each) will be taken from the 1-ppm dose level concentration o f diet preparations mixed pretest. One sample will be analyzed on the day o f mixing and used as the baseline value. One sample will be stored at room temperature for at least 19 days, then analyzed. A third sample will be stored at room temperature after at least 32 days, then analyzed. The remaining sample will be stored in a freezer set to maintain -10 to -30 C for 8 weeks, then analyzed. In addition, two samples (approximately 100 g each) will be taken from the 500-ppm dose preparation mixed pretest. One sample will be analyzed on the day o f mixing. The second sample will be will be stored at room temperature after at least 32 days, then analyzed. Dose Confirmation During the in-life phase, samples (approximately 100 g) from all dose preparations will be analyzed. All samples will be stored at room temperature until analyzed. 004683 B6- Observation of Animals Covance 6329-225 __________ Page 9 Clinical Observations Each animal will be observed twice daily (a.m. and p.m.) for mortality and moribundity, recording findings as they are observed. A t least once weekly, each animal will be observed (cage will be opened, and the animal will be removed); abnormal findings o r an indication o f normal will be recorded. Additional findings will be recorded as they are observed. Body W eights Each animal will be weighed at least once prior to treatment, on the first day o f treatment, and weekly thereafter. Food Consumption Food consumption will be recorded weekly during treatment. Food consumption will not be measured during Week 5 for animals scheduled for sacrifice during W eek 5. Ophthalmic Examinations Ophthalmic examinations will be done for each animal before initiation o f treatment and before the Week 14 scheduled sacrifice. The eyes o f each animal will be examined by a veterinarian using an indirect ophthalmoscope. A mydriatic agent will be instilled into the eyes prior to examination. Clinical Pathology Frequency Hematology and clinical chemistry during Weeks 5 and 14; urinalysis during W eek 14 N um ber of Animals Ten animals/sex/group (the same animals will be used at each interval, if possible) M ethod of Collection Animals will 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). W- 004684 Covance 6329-225 _________ Page 10 Tests Hematology 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 blood cell morphology reticulocyte smear (made, but not examined) glucose urea nitrogen creatinine total protein albumin globulin cholesterol triglycerides 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 o f sediment Serum Perfluorooctane Sulfonic Acid (PFOS) Analyses Frequency and N um ber of Animals Five animals/sex/group after at least 4 and 13 weeks o f treatment. Samples after 4 weeks o f treatment will be collected from animals selected for the interim sacrifice. 004685 --1 Covance 6329-225 _________ Page 11 Method of Collection Animals will be fasted overnight; blood (approximately 4 mL) will be collected from a jugular vein. Samples will be collected without anticoagulant. Sample Handling 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 Serum samples will be analyzed for PFOS and metabolites by the Sponsor. Results will be reported separately by the Sponsor. T erm ination Unscheduled Sacrifices and Deaths Necropsies will be done. Animals to be sacrificed will be anesthetized with carbon dioxide, weighed, and exsanguinated. Scheduled Sacrifices After at least 4 weeks o f treatment, five animals/sex/group will be fasted overnight, bled for serum samples, anesthetized with carbon dioxide, weighed, and exsanguinated. The abdominal cavity of each animal will be opened, the liver will be removed and weighed, and liver samples will be collected for palimitoyl CoA and PFOS analysis. Animals will be discarded after liver collection. 004686 XT39 Covance 6329-225 _________ Page 12 After at least 13 weeks o f treatment, all surviving animals will be fasted overnight, bled for serum samples (five animals/sex/group) and clinical pathology tests (10/sex/group), anesthetized with carbon dioxide, weighed, exsanguinated, and necropsied. Liver samples will be collected for palimitoyl CoA, PCNA, and PFOS analysis. Postmortem Procedures Necropsy The 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. Organ Weights A t the scheduled sacrifice after 13 weeks o f treatment, the following organs (when present) will be weighed; paired organs will be weighed together: a d r e n a l(2) brain 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 Marrow Smear From the femur o f each animal at the scheduled sacrifice after 13 weeks o f treatment only; made but not examined Cell Proliferation Tissue Collection and Immunohistochemical Evaluation At the scheduled sacrifice after 13 weeks o f treatm en t, representative samples o f left lateral lobe of the liver from each animal will be collected and preserved in zinc formalin. After fixation, each sample o f liver will be embedded in paraffin, and the paraffin blocks will be shipped to: 004687 140 Covance 6329-225 _________Page 13 Sandra R. Eldridge, PhD Pathology Associates International 15 Worman's Mill Court, Suite I Frederick, Maryland 21701 Telephone No.: 301.663.1644, ext. 2201 Facsimile No: 301.663.8994 Proliferation cell nuclear antigen (PCNA) evaluation will be done on the samples. Results will be provided for inclusion in the final report. Palmitoyl-CoA Oxidase Tissue Collection and Analyses At the scheduled sacrifices, the right lateral lobe o f the liver will 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 -80 C until analyzed by Covance for palmitoyl-CoA oxidase activity. Liver PFOS Analysis At scheduled sacrifices, the remaining portion of the liver from each animal after other required collections will be 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. Liver samples will be analyzed for PFOS and metabolites by the Sponsor. Results will be reported separately by the Sponsor. Tissue Preservation The following tissues (when present) from each animal that is found dead, sacrificed at an unscheduled interval, or sacrificed at the scheduled sacrifice after 13 weeks o f treatment will be preserved inl0% neutral-buffered formalin: 004688 141 Covance 6329-225 _________Page 14 adrenal(2) aorta brain cecum cervix colon duodenum epididymis (2) esophagus eye (2) femur with bone marrow (articular surface of the 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 vesicle (2) skeletal muscle (thigh) skin spinal cord (cervical, mid-thoracic, and lumbar) spleen sternum with bone marrow stomach testis (2) thymus thyroid (2) with parathyroid trachea urinary bladder uterus vagina Zymbal's gland H istopathology Tissues (as appropriate) from each animal in the control and high-dose groups and each animal that dies or is sacrificed at an unscheduled interval will be embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically. Macroscopic lesions from animals in the low- and mid-dose groups will be embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically. Suspected target organs noted at the high dose will be examined microscopically from each animal (at the Sponsor's request and added by amendment). Reports One copy o f the draft report will be sent to the Sponsor. The report will include the following information: 142 0*04689 Experimental Design and Methods Covance 6329-225 _________ Page 15 Results dose analyses mortality clinical observations body weights body weight changes food consumption test material consumption ophthalmic findings clinical pathology results palmitoyl CoA 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 o f heterogeneity o f variance at p s 0.05, transformations will be used to stabilize the variance. Comparison tests will take variance heterogeneity into consideration. One-way analysis o f 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 W eek 1, one-way analysis o f 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 4 versus Group 1) will be evaluated at the 5.0%, two-tailed probability level. Only data collected on or after the first day o f treatment will be analyzed statistically. 004690 143 Covance 6329-225 _________________________________________________________________________________ Page 16 At the end of 1 year after issuance o f the audited draft report, if no requested revisions o r 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. Two copies o f the signed final report (one unbound and one bound) will be sent to the client. Record Retention All raw data, documentation, records, protocol, specimens, and final report 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 following submission o f the final report to the Sponsor. One year after submission of the final report, the aforementioned materials will be sent to the Sponsor, and a return fee will be charged; all raw data stored on magnetic media, protocol, study correspondence, and the original final report will be retained by Covance. The 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 antigen evaluation data will be retained by Pathology Associates International. Liver and serum samples sent to the Sponsor and analysis data will be retained by the Sponsor. 444. 004691 PROTOCOL APPROVAL Covance 6329-225 _________ Page 17 3M 004692 C O V /H tf^ > THE DEVELOPMENT SERV IC ES COMPANY PROTOCOL AMENDMENT NO. 1 Covance 6329-225 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Sponsor Study Monitor: Testing Facility: Study D irector 3M, St. Paul, Minnesota Andrew M. Seacat, PhD Covance Laboratories Inc., Madison, Wisconsin Peter J. Thomford, PhD This amendment modifies the following portion o f the protocol: Effective August 27,1998 1. Page 3, Proposed Study T im etable. To correct the audited draft report date, delete the text in this section and replace with the following: In-Life Start Date: September 1,1998 In-Life End Date: December 3,1998 Audited Draft Report Date: May 26, 1999 Effective O ctober 1,1998 2. Page 12, Postm ortem Procedures, Cell Proliferation Tissue Collection a n d Im m unohistochem ical E valuation, P a ra g ra p h 1. To reflect the decision to perform proliferation cell nuclear antigen evaluation for five animals/sex/group only, delete this paragraph and replace with the following: At the scheduled sacrifice after 13 weeks o f treatment, representative samples o f the left lateral lobe of the liver from five animals/sex/group will be collected and preserved in zinc formalin. 004693 -W6- Covance 6329-225 _P_ro_t_oc_o_l_A_m__e_nd_m__enPt Nagoe. 21 AMENDMENT APPROVAL /-- Andrew M. Seacat, PhD Study Monitor 3M Date _ Jo Date ` 004694 147 COV/VNTc IT^ THE DEVELOPMENT SERV ICES COMPANY PROTOCOL AMENDMENT NO. 2 Covance 6329-225 13-Week 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 Andrew M. Seacat, PhD Covance Laboratories Inc., Madison, Wisconsin Peter J. Thomford, PhD This amendment modifies the following portion o f the protocol: Effective O ctober 21,1998 1. Page 8, Dose P rep aratio n , Dose A nalysis, S tability. To reflect the decision to perform additional stability analysis, add the following to this section: Two additional samples (approximately 100 g each) will be taken from the 3-ppm dose preparation mixed for Week 9 through 12. One sample will be stored at room temperature for at least 19 days, then analyzed. The second sample will be stored at room temperature for at least 32 days, then analyzed. The sample collected for dose confirmation analysis will be used as the baseline sample. 04635 148 Covance 6329-225 Protocol Amendment No. 2 _________________Page 2 Effective December 4,1998 2. Page 13, P ostm ortem P rocedures, L iver PFO S A nalysis, Sentence 1. To clarify collection of liver sections for PFOS analysis, delete this sentence and replace with the following: At scheduled sacrifices, the remaining portion o f the liver from each animal after other required collections will be flash-frozen in liquid nitrogen and stored in a freezer set to maintain -60 to -80C. Effective December 15,1998 3. Page 13, Postm ortem P rocedures, Cell P roliferation Tissue Collection an d Im m unohistochem ical E valuation, P arag rap h 3. To include examination o f liver sections will be stained with hematoxylin and eosin as part o f the cell proliferation evaluation, delete this paragraph and replace with the following: Proliferation cell 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. Effective January 25,1999 4. Page 14, Postm ortem Procedures, H istopathology, P a ra g ra p h 3. Liver and stomach were identified as target organs in animals in the high-dose group and will be examined in animals from the mid-dose group. Therefore delete this paragraph and replace with the following: Liver and stomach from each animal in the mid-dose group will be embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically. 004696 149 Covance 6329-225 Protocol Amendment No.2 _________________ Page 3 Effective February 8,1999 5. Page 14, P ostm ortem P ro ced u res, H istopathology, P a ra g ra p h 3. Liver and was identified as target organ in animals in the mid-dose group and will be examined in animals from the low-dose group. Therefore delete this paragraph and replace with the following: Liver and stomach from each animal in the mid-dose group and liver from each animal in the low -dose group will be embedded in paraffin, sectioned, stained w ith hematoxylin and eosin, and examined microscopically. AMENDMENT APPROVAL Andrew M. Seacat, PhD Study Monitor 3M Pet Stu Covance Laboratories Inc. 004697 150 C O V M li> THE DEVELOPMENT SERVICES COMPANY DRAFTPROTOCOL AMENDMENTNO.3 Covance 6329-225 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats SponsorStudy Monitor: Testing Facility: Study Director: 3M, St. Paul, Minnesota Andrew M. Seacat, PhD Covance Laboratories Inc., Madison, Wisconsin Peter J. Thomford, PhD This amendment modifies the following portion o f the protocol: Effective August 28,1998 1. Page 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 151 004698 Covance 6329-225 Protocol Amendment No. 3 _________________ Page 2 Storage Conditions At room temperature Characteristics Information on synthesis methods, composition, or other characteristics that define the vehicle is on file with the manufacturer. AMENDMENT APPROVAL Andrew M. Seacat, PhD Study Monitor 3M Peter J. Thomford, PhD Study Director Covance Laboratories Inc. Date Date 004699 152 APPENDIX 2 Individual Animal Fate Data Individual Clinical Observations Individual Ophthalmic Observations Covance 6329-225 3M T-6314.1 004700 153 APPENDIX 2 Individual Animal Fate Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 1 ANIMAL DOSE NUMBER GROUP C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95911 C95912 C95913 C95914 C95915 C95916 C95917 C95918 C95919 C95920 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95931 C95932 C95933 C95934 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 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 1 1 1 1 1 T T T T T T T T T T T T T T T i i i i 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 FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM 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 FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE DATE OF DAY OF DEATH STUDY 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 WEEK OF STUDY 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 Ni O b* 154 \V % iI 004702 APPENDIX 2 Individual Animal Fate Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 2 ANIMAL DOSE NUMBER GROUP C95935 C95936 C95937 C95938 C95939 C95940 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956 C95957 C95958 C95959 C95960 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 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 1 T T T T T T T T T T T T T T T 1 1 1 1 1 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 FIRST INTERIM 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 FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM 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 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 31 93 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 93 93 93 93 93 93 93 93 93 93 93 93 WEEK OF STUDY 5 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 14 14 14 14 14 14 14 14 14 14 14 14 JJ t f r i APPENDIX 2 Individual Animal Fate Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 3 ANIMAL DOSE NUMBER GROUP SEX C95969 4 MALE C95970 4 MALE C95971 4 MALE C95972 4 MALE C95973 4 MALE C95974 4 MALE C95975 4 MALE C95976 4 MALE C95977 4 MALE C95978 4 MALE C95979 4 MALE C95980 4 MALE C95981 1 FEMALE C95982 1 FEMALE C95983 1 FEMALE C95984 1 FEMALE C95985 1 FEMALE C95986 1 FEMALE C95987 1 FEMALE C95988 1 FEMALE C95989 1 FEMALE C95990 1 FEMALE C95991 1 FEMALE C95992 1 FEMALE C95993 1 FEMALE C95994 1 FEMALE C95995 1 FEMALE C95996 1 FEMALE C95997 1 FEMALE C95998 1 FEMALE C95999 1 FEMALE C96000 1 FEMALE C96001 2 FEMALE C96002 2 FEMALE DEATH CODE T T i i i i i T T T T T T T T T T T T T T T 1 1 1 1 1 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 FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM 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 FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE DATE OF DAY OF DEATH STUDY 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 93 93 31 31 31 31 31 93 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 93 93 93 93 93 93 WEEK OF STUDY 14 14 5 5 5 5 5 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 14 14 14 14 14 14 004703 156 ! APPENDIX 2 Individual Animal Fate Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 4 ANIMAL DOSE NUMBER GROUP SEX C96003 2 FEMALE C96004 2 FEMALE C96005 2 FEMALE C96006 2 FEMALE C96007 2 FEMALE C96008 2 FEMALE C96009 2 FEMALE C96010 2 FEMALE C96011 2 FEMALE C96012 2 FEMALE C96013 2 FEMALE C96014 2 FEMALE C96015 2 FEMALE C96016 2 FEMALE C96017 2 FEMALE C96018 2 FEMALE C96019 2 FEMALE C96020 2 FEMALE C96021 3 FEMALE C96022 3 FEMALE C96023 3 FEMALE C96024 3 FEMALE C96025 3 FEMALE C96026 3 FEMALE C96027 3 FEMALE C96028 3 FEMALE C96029 3 FEMALE C96030 3 FEMALE C96031 3 FEMALE C96032 3 FEMALE C96033 3 FEMALE C96034 3 FEMALE C96035 3 FEMALE C96036 3 FEMALE DEATH CODE TYPE OF DEATH DESCRIPTION OF DEATH T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE M UNSCHEDULED UNSCHEDULED DEATH T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE 1 SCHEDULED FIRST INTERIM SACRIFICE T SCHEDULED TERMINAL SACRIFICE DATE OF DAY OF DEATH STUDY 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 10/29/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 93 93 93 93 93 93 93 93 31 31 31 31 31 59 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 WEEK OF STUDY 14 14 14 14 14 14 14 14 5 5 5 5 5 9 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 004704 157 i APPENDIX 2 Individual Animal Fate Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 5 ANIMAL DOSE NUMBER GROUP SEX C96037 3 FEMALE C96038 3 FEMALE C96039 3 FEMALE C96040 3 FEMALE C96041 4 FEMALE C96042 4 FEMALE C96043 4 FEMALE C96044 4 FEMALE C96045 4 FEMALE C96046 4 FEMALE C96047 4 FEMALE C96048 4 FEMALE C96049 4 FEMALE C96050 4 FEMALE C96051 4 FEMALE C96052 4 FEMALE C96053 4 FEMALE C96054 4 FEMALE C96055 4 FEMALE C96056 4 FEMALE C96057 4 FEMALE C96058 4 FEMALE C96059 4 FEMALE C96060 4 FEMALE DEATH CODE T T T T T T T T T T T T T T 1 1 1 1 1 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 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 FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE DATE OF DAY OF DEATH STUDY 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 93 93 93 93 WEEK OF STUDY 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 14 14 14 14 004705 158 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T - 6314.1 PAGE: 1 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: Ml DOSE: 0 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C' - COMMENTS LISTED AT END OF OBSERVATIONS C9S901 C95902 C95903 T T T C95904 T C95905 C95906 C95907 C95908 C95909 T T T T T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION SKIN & PELAGE BLACK SKIN TAIL-DISTAL 14 DISCHARGE GENITAL RED IN COLOR 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 29, 36 50, 57, 64, 71 92 71, 78, 85, 92-93 004706 159 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 2 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: Ml DOSE: 0 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C` - COMMENTS LISTED AT END OF OBSERVATIONS C95910 C95911 C95912 C95913 T 1 1 1 C95914 C95915 C95916 C95917 C95918 C95919 C95920 1 1 T T T T T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 APPEARANCE MALOCCLUSION 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS oc o 4 160 \ Appendix 2 Individual Clinical Observations. 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 3 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M2 DOSE: 3 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; C` - COMMENTS LISTED AT END OF OBSERVATIONS C95921 T C95922 C95923 C95924 C95925 T T T T C95926 C95927 C95928 C95929 C95930 T T T T T C95931 1 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION THIN 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 22, 29 71, 78, 85, 92-93 71 64, 71, 78 004708 161 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 4 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M2 DOSE: 3 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; C - COMMENTS LISTED AT END OF OBSERVATIONS C95932 C95933 C95934 C95935 C95936 i i i i T C95937 T C95938 C95939 C95940 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 14 APPEARANCE MALOCCLUSION 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 78, 85, 92-93 78, 85, 92-93 ' 29, 36, 43, 50, 57, 64, 71, 78, 85, 92-93 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 5 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M3 DOSE: 30 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C - COMMENTS LISTED AT END OF OBSERVATIONS C95941 C95942 T T C95943 C95944 C95945 C95946 C95947 T T T T T C95948 C95949 T T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION SKIN & PELAGE YELLOW HAIR COAT PENIS 50, 57, 64, 71, 78, 85, 92-93 43, 50, 57, 64, 71 85, 92-93 92-93 004710 163 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 6 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M3 DOSE: 30 PPM DAYS 1-93 OBSERVED DURING THE DAYS LISTED BELOW; `C* - COMMENTS LISTED AT END OF OBSERVATIONS C95950 C 95951 C95952 C95953 C95954 C95955 C95956 C95957 C95958 C95959 C95960 T 1 1 1 1 1 T T T T T 14 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 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 004711 164 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 7 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M4 DOSE: 100 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C1 - COMMENTS LISTED AT END OF OBSERVATIONS C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 T T T T T T T T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION MISSING TEETH DISCHARGE NASAL RED IN COLOR EYES RED DISCHARGE EYES RESPIRATION AUDIBLE 55, 57, 64, 71, 78, 85, 92-93 55 55 55 55 ZT.VOO 165 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 8 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: M4 DOSE: 100 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C' - COMMENTS LISTED AT END OF OBSERVATIONS C95969 C95970 T T C95971 1 C95972 C95973 C95974 C95975 C95976 C95977 C95978 C95979 C9S980 1 1 1 1 T T T T T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 5 APPEARANCE MALOCCLUSION 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 64, 71, 78, 85, 92-93 29, 31 29, 36 4 \ t, 004713 166 f Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 9 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: FI DOSE 0 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; C' - COMMENTS LISTED AT END OF OBSERVATIONS C95981 T C95982 C95983 C95984 C95985 C95986 T T T T T C95987 C95988 C95989 C95990 T T T T 14 APPEARANCE LIMITED USE LIMB-HIND--LEFT SWOLLEN LIMB-HIND--LEFT 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 64 64 85, 92-93 004714 167 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 10 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: FI DOSE: 0 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; C` - COMMENTS LISTED AT END OF OBSERVATIONS C95991 C95992 C95993 C95994 C95995 C9S996 C95997 C95998 C95999 C96000 i i i i i 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 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 004715 168 i Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 11 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: F2 DOSE: 3 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; `C* - COMMENTS LISTED AT END OF OBSERVATIONS C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 C96011 C96012 C96013 T T T T T T T T T T 1 1 1 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 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 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: F2 DOSE: 3 PPM DAYS 1-93 - OBSERVED DURING THE DAYS *C* - COMMENTS LISTED AT C96014 C96015 C96016 1 1 M C96017 T C96018 T C96019 C96020 T T 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 9 APPEARANCE MALOCCLUSION SKIN b PELAGE SORE/SCAB TAIL 14 APPEARANCE MALOCCLUSION 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 22, 29 59 78, 85, 92-93 15 Covance 6329-225 3M T-6314.1 PAGE: 12 004717 170 I Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP : F3 DOSE : 30 PPM DAYS 1-93 - OBSERVED DURING THE DAYS C' - COMMENTS LISTED AT C96021 C96022 C96023 C96024 C96025 T T T T T C96026 T C96027 C96028 T T C96029 T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION SKIN & PELAGE SORE/SCAB MOUTH 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 78, 85, 92-93 57, 64 78, 85, 92-93 78 Covance 6329-225 3M T-6314.1 PAGE: 13 04718 171 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 14 CATEGORY KEYWORD QUALIFIER GROUP: F3 DOSE: 30 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; C' - COMMENTS LISTED AT END OF OBSERVATIONS 14 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 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 172 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 15 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: F4 DOSE: 100 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C` - COMMENTS LISTED AT END OF OBSERVATIONS C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 T T T T T T T T C96049 T C96050 C96051 T 1 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 14 APPEARANCE MISSING TAIL-DISTAL 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 50 36, 43, 50, 57, 64, 71, 78, 85, 92-93 004?2o 173 i Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 16 CATEGORY ; of KEYWORD :a t h QUALIFIER GROUP: F4 DOSE: 100 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; C' - COMMENTS LISTED AT END OF OBSERVATIONS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 174 ANIMAL NUMBER C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95916 C95917 C95918 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: Ml DOSE: 0 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 1 h1 \S| [' i 004722 175 1 ! 4 I' i ANIMAL NUMBER C95919 C95920 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: Ml DOSE: 0 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 2 i 004723 176 i f * ANIMAL NUMBER C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95936 C95937 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: M2 DOSE: 3 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS CONJUNCTIVA CONJUNCTIVITIS EYES ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS 14 Covance 6329-225 3M T-6314.1 PAGE: 3 [' 1 004724 177 i 4 'I ANIMAL NUMBER C95938 C95939 C95940 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: M2 DOSE: 3 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 4 ! 004725 178 ANIMAL NUMBER C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95956 C95957 Appendix 2 Individual Ophthalmic Observations Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: M3 DOSE: 30 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS RETINA RETINAL DEGENERATION-FOCAL EYE-RIGHT ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 5 004726 179 i ANIMAL NUMBER C95958 C95959 C95960 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: M3 DOSE: 30 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 6 S 4 004727 180 ANIMAL NUMBER C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 C95976 C95977 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: M4 DOSE: 100 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS CONJUNCTIVA CONJUNCTIVITIS EYE-LEFT ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 7 004728 181 ANIMAL NUMBER C95978 C95979 C95980 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: M4 DOSE: 100 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 8 004729 182 ANIMAL NUMBER C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95996 C95997 C95998 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: FI DOSE: 0 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 9 004730 183 i ANIMAL NUMBER C95999 C96000 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: Fl DOSE: 0 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 10 004731 184 ANIMAL NUMBER C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 C96016 C96017 C96018 Appendix 2 Individual Ophthalmic Observations Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: F2 DOSE: 3 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 11 004732 185 I ANIMAL NUMBER C96019 C96020 Appendix 2 Individual Ophthalmic Observations Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: F2 DOSE: 3 PPM MEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 12 004733 186 i ANIMAL NUMBER C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96036 C96037 C96038 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: F3 DOSE: 30 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 13 004734 187 i ANIMAL NUMBER C96039 C96040 Appendix 2 Individual Ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: F3 DOSE: 30 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 14 004735 188 ANIMAL NUMBER C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96057 C96058 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: F4 DOSE: 100 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 15 4 004736 189 i i 4 > ( ANIMAL NUMBER C96059 C960G0 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CATEGORY KEYWORD QUALIFIER GROUP: F4 DOSE: 100 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance G329-225 3M T-6314.1 PAGE: 1G 004737 190 APPENDIX 3 Individual Body Weight Data (g) Covane* 6329-225 3M T-6314.1 004738 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: MALE 1 - 0 PPM C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95911 C95912 C95913 C95914 C95915 C95916 C95917 C95918 C95919 C95920 208 216 204 206 204 197 208 202 203 215 225 222 234 202 185 226 205 209 213 216 261 271 254 259 257 250 253 262 254 272 273 281 299 256 219 284 264 262 270 267 GROUP : MALE 2 - 3 PPM C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 215 207 201 232 227 206 202 199 267 256 253 281 282 250 251 257 WEEK 3 WEEK 4 WEEK 5 WEEK 67 WEEK 8 WEEK 9 314 352 380 391 420 430 321 362 392 407 433 444 308 355 374 398 424 437 315 361 395 409 436 453 303 341 376 386 411 433 304 355 391 411 445 461 298 342 366 383 406 417 316 364 399 417 442 461 288 319 352 359 384 395 326 377 415 429 457 477 304 337 361 334 389 411 345 353 402 302 349 377 245 27 6 293 342 389 425 462 487 506 324 370 400 428 454 474 321 371 395 418 438 458 326 370 405 427 452 465 317 360 397 422 443 464 312 350 372 389 411 422 301 345 374 389 413 421 306 346 374 390 418 437 327 360 388 406 427 445 334 376 402 418 439 461 294 324 350 366 380 401 299 336 359 373 397 417 314 359 391 404 429 447 Covance 6329-225 3M T-6314.1 PAGE: 1 WEEK 455 473 459 472 453 485 438 480 417 505 WEEK 10 473 491 472 485 466 507 455 497 428 533 531 545 502 510 476 485 491 506 481 504 449 466 453 466 465 479 465 479 480 494 421 433 434 454 466 477 004739 192 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 1 WEEK 2 GROUP : MALE 2 - 3 PPM C95929 C95930 C95931 C95932 C95933 C95934 C95935 C95936 C95937 C95938 C95939 C95940 208 220 210 203 206 191 208 224 217 221 209 214 259 275 258 252 260 238 261 290 273 283 255 263 GROUP : MALE 3 - 30 PPM C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956 199 203 230 209 205 204 202 216 219 215 236 205 207 225 198 209 245 248 283 263 261 253 252 265 27 6 268 297 250 258 279 259 264 WEEK 3 311 329 316 303 308 283 318 355 321 335 299 311 284 294 331 307 315 294 299 316 332 323 351 294 308 332 314 318 WEEK 4 351 374 367 342 353 322 361 408 3 57 380 341 350 318 325 371 347 355 336 337 3 58 383 3 64 392 329 342 374 350 366 WEEK 5 377 398 398 365 381 3 52 392 436 378 406 3 63 383 342 347 397 366 385 369 368 380 413 389 416 347 3 62 404 3 81 396 WEEK 6 393 413 465 395 426 384 398 357 360 408 382 395 386 381 397 428 407 425 WEEK 7 418 441 496 412 451 404 418 373 380 429 404 418 410 397 419 457 431 448 WEEK 8 436 449 511 421 466 413 432 387 372 452 413 443 425 415 433 478 445 469 Covance 6329-225 3M T-6314.1 PAGE: 2 WEEK 9 WEEK 10 461 475 472 477 528 554 444 459 486 505 433 442 455 470 403 407 400 408 466 486 430 438 462 477 450 464 433 451 457 467 502 513 463 465 489 505 004740 193 I Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK i WEEK 2 GROUP: MALE 3 - 30 PPM C95957 C95958 C95959 C95960 226 205 190 214 279 261 244 264 GROUP: MALE 4 - 100 PPM C95961 C9S962 C95963 C95964 C95965 C95966 C9S967 C95968 C95969 C95970 C95971 C95972 C95973 C95974 C95975 C95976 C95977 C95978 C95979 C95980 227 205 217 222 195 197 204 206 219 232 203 200 184 197 214 200 209 212 204 219 284 252 264 266 245 245 256 258 277 281 252 253 234 246 262 244 256 268 255 269 WEEK 3 326 308 290 317 334 292 310 317 283 284 301 310 317 329 298 304 271 293 306 283 299 313 300 313 WEEK 4 3 67 343 323 348 373 321 343 351 313 317 334 349 351 3 62 336 341 295 320 334 312 330 344 334 342 WEEK 5 389 369 353 383 402 345 369 382 333 349 363 377 377 385 340 367 311 343 357 332 358 367 359 369 WEEK 6 411 389 372 399 417 356 389 389 344 360 374 390 386 394 350 376 391 379 382 WEEK 7 427 406 392 420 442 381 412 418 371 386 399 422 417 427 361 400 410 398 397 WEEK 8 440 420 401 426 456 397 427 434 382 405 408 437 432 434 367 416 422 407 409 Covance 6329-225 3M T-6314.1 PAGE: 3 WEEK 9 WEEK 10 460 474 438 459 421 436 446 452 476 489 412 423 452 463 447 456 393 411 426 438 423 438 417 448 451 463 453 447 380 388 432 448 439 449 419 429 429 437 004741 194 i Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 1 WEEK 2 GROUP : FEMALE 1 - 0 PPM C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95991 C95992 C95993 C95994 C95995 C95996 C95997 C95998 C95999 C96000 156 142 146 169 162 169 146 150 153 172 168 148 158 172 152 165 152 167 173 161 191 175 173 192 195 190 173 171 189 208 193 167 180 194 162 194 17 6 194 194 180 GROUP : FEMALE 2 - 3 PPM C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 143 142 153 176 165 150 164 168 161 160 168 153 187 170 188 186 WEEK 3 220 213 186 215 213 218 182 182 204 225 214 177 184 217 181 210 192 202 222 206 187 17 6 190 124 205 187 202 217 WEEK 4 240 216 195 241 234 230 213 215 228 256 219 203 207 229 201 237 211 226 260 225 204 178 201 198 221 210 226 229 WEEK 5 256 224 214 247 240 236 211 217 249 280 240 213 218 245 207 244 219 237 286 232 201 200 196 218 224 218 234 238 WEEK 6 260 234 211 243 254 247 218 232 252 279 258 223 241 300 248 214 205 207 236 232 220 245 246 WEEK 7 273 241 224 251 262 260 220 239 254 292 260 233 241 318 261 224 209 217 243 236 232 244 261 WEEK 8 287 246 219 254 267 262 229 234 262 301 264 238 246 318 261 228 209 215 239 241 234 250 260 Covance 6329-225 3M T-6314.1 PAGE: 4 WEEK 9 WEEK 10 286 288 256 261 229 231 263 276 270 286 262 273 240 250 250 251 286 283 302 322 271 276 249 252 244 250 332 345 268 275 243 249 222 231 219 226 251 260 252 254 244 248 260 266 277 279 004742 195 ! Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-22S 3M T-6314.1 PAGE: 5 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: FEMALE 2 - 3 PPM C96009 C96010 C96011 C96012 C96013 C96014 C96015 C96016 C96017 C96018 C96019 C96020 140 162 149 149 169 167 155 177 164 160 178 154 156 184 184 167 195 193 178 206 194 189 203 184 GROUP: FEMALE 3 - 3 0 PPM C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96031 C96032 C96033 C96034 C96035 C96036 144 167 167 174 171 150 165 168 151 151 159 158 160 167 169 164 162 193 189 196 194 168 194 178 173 169 182 177 190 193 203 185 WEEK 3 WEEK 4 WEEK 56 WEEK 7 WEEK 166 170 181 190 200 209 216 232 240 249 203 246 250 193 213 223 217 239 250 214 245 260 205 228 236 232 245 252 266 271 224 257 271 291 287 224 239 243 265 272 228 245 247 264 271 193 222 224 237 239 182 211 222 225 227 221 232 250 249 256 210 219 234 234 243 220 235 237 243 255 197 223 232 235 243 188 206 213 211 228 222 245 258 266 277 217 224 237 240 248 197 206 223 227 23 6 189 211 220 223 23 6 191 219 230 195 220 230 210 233 240 220 246 262 227 240 245 206 226 231 238 249 WEEK 8 WEEK 9 198 205 249 265 273 284 287 295 275 283 280 289 242 252 234 242 261 271 244 255 252 269 250 251 230 232 280 297 258 266 236 245 241 251 254 261 WEEK 10 216 270 296 281 288 256 249 275 264 273 265 233 300 269 251 251 266 I 004743 196 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 1 WEEK 2 GROUP : FEMALE 3 C96037 C96038 C96039 C96040 158 161 156 140 GROUP : FEMALE 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96051 C96052 C96053 C96054 C96055 C96056 C96057 C96058 C96059 C96060 140 163 151 169 164 170 160 157 144 150 153 179 152 156 155 155 166 169 141 165 30 PPM 190 178 181 162 100 PPM 164 184 170 198 182 190 171 188 158 165 163 192 169 174 169 174 196 193 164 188 WEEK 3 202 203 201 170 180 200 188 217 207 211 185 199 163 187 185 208 17 6 180 172 190 218 224 17 6 213 WEEK 4 226 221 225 188 194 213 202 236 218 226 198 215 180 199 199 223 206 198 193 194 222 228 174 221 WEEK 5 228 228 233 198 200 216 209 241 222 238 200 221 188 205 199 228 218 209 198 206 237 230 193 233 WEEK 6 238 244 243 208 201 224 211 253 234 249 206 227 189 205 215 248 241 199 245 WEEK 7 242 256 254 219 205 229 219 259 244 258 209 231 187 212 222 256 246 210 243 WEEK 8 248 261 254 219 215 231 222 258 250 263 214 227 189 214 214 258 251 206 247 Covance 6329-225 3M T-6314.1 PAGE: 6 WEEK 9 WEEK 10 260 267 263 27 6 267 270 224 237 223 224 239 239 226 227 268 271 255 263 269 277 219 224 239 241 198 202 216 221 222 227 262 264 257 257 218 222 258 262 004744 197 / 004745 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 GROUP: C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95916 C95917 C95918 C95919 C95920 MALE 1 - 0 PPM 481 492 505 514 484 493 501 516 478 488 525 539 468 481 508 517 430 448 550 579 561 570 529 542 493 505 520 532 511 526 GROUP: MALE 2 - 3 PPM C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95936 C95937 C95938 C95939 483 480 499 494 438 447 468 495 502 490 568 463 517 451 494 494 505 503 474 457 485 501 517 502 575 444 515 465 WEEK 13 508 533 510 531 495 561 501 526 459 596 588 559 520 551 545 500 510 529 520 498 468 497 515 540 519 577 459 532 474 WEEK 14 523 542 518 539 509 581 511 543 475 623 601 577 535 567 557 512 527 531 527 510 479 511 524 549 525 585 482 544 483 198 Covance 6329-225 3M T-6314.1 PAGE: 7 ! 004746 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 GROUP: MALE 2 - 3 PPM C95940 487 504 GROUP: MALE 3 - 30 PPM C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C9S950 C95956 C95957 C95958 C95959 C95960 419 421 501 444 486 476 457 478 534 473 518 479 471 448 460 426 427 509 452 501 480 458 493 542 482 534 487 485 458 466 GROUP: MALE 4 - 100 PPM C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 497 434 478 466 422 451 449 458 47 5 509 443 488 474 430 461 460 468 481 WEEK 13 518 435 449 529 466 513 492 463 504 517 495 543 499 500 467 477 513 457 501 485 443 468 472 485 485 WEEK 14 524 448 454 534 475 524 502 471 515 413 502 558 516 502 47 6 481 522 468 511 499 453 482 480 494 500 199 Covance 6329-225 3M T-6314.1 PAGE: 8 004747 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 GROUP : MALE 4 - 100 PPM C95970 C95976 C95977 C95978 C95979 C95980 460 393 458 465 441 442 462 404 469 475 452 450 GROUP : FEMALE 1 - 0 PPM C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95996 C95997 C95998 C95999 C96000 292 262 240 280 293 281 251 264 284 330 278 256 257 362 286 313 267 241 285 297 285 256 261 299 332 281 266 262 372 292 GROUP : FEMALE 2 - 3 PPM C96001 C96002 C96003 C96004 245 236 234 267 253 237 231 268 WEEK 13 468 408 479 485 459 458 307 271 241 284 296 290 264 276 311 349 292 271 266 388 290 253 243 232 279 WEEK 14 473 418 490 490 469 465 331 275 246 299 312 297 272 283 310 341 291 277 267 394 298 263 251 244 298 200 Covance 6329-225 3M T-6314.1 PAGE: 9 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 GROUP: FEMALE 2 - 3 PPM C96005 C96006 C96007 C96008 C96009 C96010 C96017 C96018 C96019 C96020 257 251 268 289 216 274 303 299 300 257 261 258 271 296 218 275 301 292 298 261 GROUP: FEMALE 3 - 30 PPM C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96036 C96037 C96038 C96039 C96040 247 274 265 271 273 247 300 280 252 254 270 261 282 274 239 254 284 265 273 274 249 312 279 252 258 270 273 290 276 241 WEEK 13 266 266 280 300 226 283 318 307 313 260 258 283 274 278 265 257 322 290 257 262 276 269 291 285 239 WEEK 14 269 274 292 305 231 292 303 306 321 267 262 292 277 283 27 5 255 323 295 265 262 275 283 304 284 251 Covance 6329-225 3M T-6314.1 PAGE: 10 004748 201 I Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 GROUP: FEMALE 4 -- 100 PPM C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96057 C96058 C96059 C96060 222 242 232 27 6 269 279 224 248 203 225 228 270 256 227 267 231 246 239 282 271 283 226 243 207 228 224 267 262 219 269 WEEK 13 WEEK 14 234 249 242 283 273 284 227 247 . 208 233 226 27 6 269 228 27 5 236 247 239 287 280 290 231 259 213 239 229 279 271 232 271 Covance 6329-225 3M T-6314.1 PAGE: 11 004749 202 APPENDIX 4 Covance 6329-225 3M T-6314.1 Individual Food Consumption Data (g) Individual Test Material Consumption (mg/kg/day) _Q A O 04750 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 1 WEEK 2 GROUP : MALE 1 - 0 PPM C95901 C95902 C95903 C95904 C95905 C95906 C9S907 C95908 C95909 C95910 C95911 C95912 C95913 C95914 C95915 C95916 C95917 C95918 C95919 C95920 165 168 172 174 160 173 176 182 164 165 161 166 156 158 177 183 152 151 175 179 172 165 187 191 181 179 164 172 136 SPILLED 176 188 187 185 168 181 178 207 164 168 GROUP : MALE 2 - 3 PPM C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 162 163 159 171 185 164 161 187 170 168 170 177 195 162 168 189 WEEK 3 171 179 17 6 191 175 182 169 192 154 191 162 194 169 180 163 191 184 186 231 179 168 175 175 179 SPILLED 167 165 188 WEEK 4 183 190 187 202 182 199 174 202 SPILLED 198 172 198 174 187 142 192 185 187 SPILLED 190 175 179 178 184 214 168 170 202 WEEK 5 159 178 162 177 166 168 157 172 147 176 192 189 184 233 192 168 158 163 164 187 157 155 SPILLED WEEK 6 WEEK 7 WEEK 8 179 181 181 197 187 187 190 182 181 203 202 208 182 SPILLED SPILLED 199 195 188 180 177 167 197 199 192 170 164 165 194 200 193 194 190 186 187 189 186 180 182 181 233 242 SPILLED 185 189 184 17 6 185 SPILLED 175 176 183 185 186 191 186 186 186 206 211 215 171 177 167 172 177 175 201 206 201 Covance 6329-225 3M T-6314.1 PAGE: 1 WEEK 9 WEEK 10 176 170 192 190 182 177 213 215 214 184 183 192 166 161 190 192 160 153 208 SPILLED 185 193 178 179 178 176 240 253 188 183 187 192 178 171 187 190 183 183 203 99 167 165 173 170 197 189 047S1 204 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: MALE 2 - 3 PPM C95929 C95930 C95931 C95932 C95933 C95934 C95935 C95936 C95937 C95938 C95939 C95940 175 186 177 194 155 SPILLED 160 165 165 172 156 161 183 195 171 189 163 172 177 189 163 174 165 171 GROUP: MALE 3 - 30 PPM C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956 154 159 156 162 178 184 174 179 168 184 169 168 151 161 166 179 172 186 168 180 181 185 155 161 178 186 184 197 194 197 208 SPILLED WEEK 3 WEEK 4 WEEK 5 191 195 191 218 195 17 6 215 SPILLED 166 173 17 6 172 164 169 197 197 203 197 192 17 5 178 184 197 204 186 187 191 199 176 184 179 158 166 152 161 166 152 190 197 162 183 186 164 191 193 179 180 189 173 166 171 152 200 188 17 6 197 201 181 189 188 168 193 192 167 174 192 187 202 216 200 210 214 228 SPILLED WEEK 6 237 208 191 184 194 185 178 162 170 186 189 198 186 168 185 207 200 259 WEEK 7 WEEK 8 234 SPILLED 190 186 194 188 186 SPILLED 197 199 184 180 187 185 159 153 145 153 189 183 180 178 197 187 184 189 162 155 183 185 209 204 191 189 246 SPILLED Covance 6329-225 3M T-6314.1 PAGE: 2 WEEK 9 WEEK 10 235 227 186 170 189 187 198 195 197 202 168 169 189 188 145 145 158 166 185 178 169 168 187 183 178 175 157 149 182 181 200 199 190 180 226 223 004752 205 i Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERPLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: MALE 3 - 30 PPM C95957 C95958 C95959 C95960 166 168 163 168 179 175 17 6 181 GROUP : MALE 4 - 100 PPM C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 C95971 C95972 C95973 C95974 C95975 C95976 C95977 C95978 C95979 C95980 183 159 172 172 159 158 170 188 181 171 159 160 165 162 164 162 163 166 170 174 189 168 171 191 168 167 178 184 179 198 166 169 170 175 168 167 174 171 175 182 WEEK 3 188 180 178 181 191 165 171 181 168 171 175 191 178 SPILLED 170 172 164 170 169 164 169 165 177 178 WEEK 4 189 182 193 200 194 167 171 194 172 173 179 197 180 187 152 172 167 172 173 165 177 170 17 6 177 WEEK 5 184 181 185 192 171 154 165 171 157 154 157 171 155 170 161 173 171 183 180 WEEK 6 181 194 193 175 200 179 184 185 177 180 179 195 183 195 163 182 172 175 181 WEEK 7 182 176 189 175 194 178 179 190 172 179 183 194 183 187 162 186 173 179 184 WEEK 8 180 183 190 178 192 171 180 185 165 178 176 159 181 187 157 181 174 170 182 Covance 6329-225 3M T-6314.1 PAGE: 3 WEEK 9 WEEK 10 176 167 188 180 188 181 167 164 188 180 171 167 183 176 179 175 169 162 180 183 179 177 158 191 178 177 174 173 155 146 184 176 180 180 171 170 180 174 004753 206 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 4 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: FEMALE 1 - 0 PPM C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95991 C95992 C95993 C95994 C95995 C95996 C95997 C95998 C95999 C96000 138 127 127 126 135 137 124 124 135 162 131 111 121 129 111 122 111 120 98 SPILLED 150 143 139 130 128 152 123 114 134 147 126 101 108 133 SPILLED 126 107 112 144 145 GROUP : FEMALE 2 - 3 PPM C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 SPILLED 103 106 169 125 SPILLED 119 148 SPILLED 106 113 45 120 SPILLED 122 SPILLED WEEK 3 153 123 SPILLED 145 133 132 163 127 144 165 135 116 119 138 162 127 114 119 145 158 SPILLED 104 110 127 122 SPILLED 133 144 WEEK 4 153 116 SPILLED 137 137 138 130 125 SPILLED 170 159 116 125 146 118 127 115 119 163 SPILLED SPILLED 121 107 SPILLED 125 SPILLED 137 148 WEEK 5 129 115 108 125 132 121 113 SPILLED 137 135 121 119 126 166 156 SPILLED 106 105 125 119 112 SPILLED 113 WEEK 6 161 126 120 138 137 SPILLED 128 130 SPILLED 156 119 SPILLED 113 171 156 121 109 106 138 125 SPILLED 132 145 WEEK 7 159 134 SPILLED 148 137 130 151 119 SPILLED 158 121 SPILLED 161 157 151 176 111 106 134 127 SPILLED 149 137 WEEK 8 129 120 102 150 135 127 129 126 SPILLED 140 113 SPILLED SPILLED 163 171 SPILLED 119 SPILLED 140 161 123 137 146 WEEK 9 104 119 SPILLED 141 13 6 132 132 125 SPILLED 147 109 SPILLED 119 163 SPILLED SPILLED 113 109 144 129 SPILLED 133 135 WEEK 10 137 114 130 131 129 128 119 126 244 147 109 SPILLED 113 181 SPILLED 107 106 109 166 120 SPILLED 136 13 6 004754 207 f Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 5 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: FEMALE 2 - 3 PPM C96009 C96010 C96011 C96012 C96013 C96014 C96015 C96016 C96017 C96018 C96019 C96020 115 117 133 113 SPILLED 131 124 122 13 6 140 131 SPILLED SPILLED 122 128 143 152 135 129 131 131 144 143 120 GROUP : FEMALE 3 - 30 PPM C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96031 C96032 C96033 C96034 C96035 C96036 SPILLED 131 117 129 133 SPILLED 208 124 129 131 135 124 124 162 149 117 178 SPILLED 125 126 123 SPILLED SPILLED 137 SPILLED 130 SPILLED 140 129 139 151 118 WEEK 3 SPILLED 127 148 SPILLED 167 144 132 130 153 158 137 126 140 149 131 129 13 5 SPILLED 188 132 159 138 163 128 137 139 136 122 WEEK 4 108 137 153 128 150 150 137 127 151 SPILLED 137 126 142 150 137 134 135 SPILLED SPILLED 135 135 139 SPILLED 131 133 164 142 118 WEEK 5 WEEK 67 WEEK 8 WEEK 9 WEEK WEEK 10 99 147 171 125 119 104 124 141 SPILLED 139 151 136 131 157 SPILLED 147 126 131 140 SPILLED 145 120 128 141 SPILLED 149 128 130 137 SPILLED 146 125 NOT TAKEN 138 139 142 117 138 146 143 114 134 SPILLED 113 117 120 SPILLED SPILLED 120 115 130 152 141 154 132 137 155 181 128 SPILLED 139 SPILLED 140 131 SPILLED 129 SPILLED SPILLED 138 SPILLED 146 127 127 138 131 134 SPILLED SPILLED 137 158 130 SPILLED 131 131 121 139 SPILLED 164 139 SPILLED 133 117 127 130 121 127 171 162 134 220 130 SPILLED 159 SPILLED 138 SPILLED SPILLED 04755 208 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 6 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: FEMALE 3 - 30 PPM C96037 C96038 C96039 C96040 130 120 185 SPILLED 127 161 SPILLED SPILLED GROUP: FEMALE 4 - 100 PPM C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96051 C96052 C96053 C96054 C96055 C96056 C96057 C96058 C96059 C96060 135 100 107 136 118 SPILLED 108 128 101 133 101 149 113 SPILLED 105 109 175 124 118 129 110 92 104 127 128 SPILLED 107 111 SPILLED SPILLED 107 126 108 SPILLED 100 108 133 133 143 123 WEEK 3 178 SPILLED SPILLED SPILLED 109 96 103 137 124 127 105 102 99 124 101 140 118 SPILLED 104 110 130 124 107 116 WEEK 4 SPILLED SPILLED SPILLED SPILLED 120 99 105 142 145 130 99 111 102 120 106 128 121 151 108 116 159 121 121 120 WEEK 5 125 SPILLED SPILLED SPILLED 106 99 102 132 124 128 102 100 94 104 112 149 127 121 122 WEEK 6 130 194 SPILLED SPILLED 125 107 109 142 148 13 6 106 110 105 117 111 137 125 124 115 WEEK 7 129 SPILLED SPILLED SPILLED 117 106 105 129 142 SPILLED 104 102 98 114 103 132 129 125 125 WEEK 8 136 SPILLED 159 SPILLED 113 109 102 141 140 151 109 111 106 109 107 133 124 SPILLED 121 WEEK 9 127 SPILLED SPILLED 225 111 104 104 135 146 149 103 114 108 111 101 124 121 SPILLED 123 WEEK 10 122 149 SPILLED SPILLED 110 96 106 128 140 125 100 115 102 108 102 135 127 SPILLED 115 004756 209 i 004757 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 GROUP: C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95916 C95917 C95918 C95919 C95920 MALE 1 - 0 PPM 167 171 180 184 17 6 182 216 213 244 SPILLED 192 199 163 168 194 195 157 157 SPILLED 198 182 184 179 183 179 181 260 SPILLED 187 186 GROUP: MALE 2 - 3 PPM C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95936 C95937 C95938 C95939 208 174 188 184 190 158 177 194 221 177 179 154 195 168 204 176 185 188 199 153 17 6 197 207 184 161 140 199 168 WEEK 13 172 180 179 198 177 190 SPILLED 194 157 208 182 SPILLED 173 241 181 203 171 169 184 193 154 167 178 189 177 172 181 188 166 210 Covance 6329-225 3M T - 6314.1 PAGE: 7 004758 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTAHESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 GROUP : MALE 2 - 3 PPM C95940 184 184 GROUP: MALE 3 - 30 PPM C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95956 C95957 C95958 C95959 C95960 147 166 175 162 183 SPILLED 143 182 192 184 233 164 184 183 161 145 169 181 163 182 174 141 178 175 190 224 167 182 185 166 GROUP : MALE 4 - 100 PPM C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 177 159 182 177 163 175 177 197 169 17 8 164 183 178 169 172 177 199 170 WEEK 13 17 5 139 181 171 158 188 167 138 182 7 188 207 165 173 178 156 178 157 175 178 168 164 166 17 5 170 211 Covance 6329-225 3M T-6314.X PAGE: 8 004759 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 GROUP : MALE 4 - 100 PPM C95970 C95976 C95977 C95978 C95979 C95980 163 SPILLED 178 170 165 174 163 146 17 5 175 172 174 GROUP : FEMALE 1 - 0 PPM C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95996 C95997 C95998 C95999 C96000 175 116 SPILLED 139 134 130 125 117 SPILLED 139 111 SPILLED SPILLED 176 SPILLED 123 109 165 124 131 125 117 131 SPILLED 148 111 213 122 168 SPILLED GROUP : FEMALE 2 - 3 PPM C96001 C96002 C96003 C96004 110 112 111 134 104 114 114 138 WEEK 13 157 147 171 169 173 176 182 109 171 128 135 111 122 114 SPILLED 117 109 SPILLED SPILLED 160 SPILLED 101 105 107 137 212 Covance 6329-225 3M T-6314.1 PAGE: 9 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 WEEK 13 GROUP : FEMALE 2 - 3 PPM C96005 C96006 C96007 C96008 C96009 C96010 C96017 C96018 C96019 C96020 120 SPILLED 141 132 SPILLED 135 118 123 139 110 116 SPILLED 149 130 129 150 127 147 143 119 113 SPILLED 13 6 126 SPILLED 130 97 SPILLED 150 113 GROUP: FEMALE 3 - 30 PPM C96021 195 127 125 C96022 132 121 126 C96023 125 121 121 C96024 123 123 118 C96025 125 107 115 C96026 SPILLED 250 220 C96027 193 183 148 C96028 116 120 124 C96029 SPILLED 177 SPILLED C96030 122 123 125 C96036 SPILLED 129 212 C96037 128 128 134 C96038 139 134 130 C96039 197 172 162 C96040 SPILLED 174 SPILLED c c Vi o03 2f i Covance 6329-225 3M T-6314.1 PAGE: 10 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 GROUP : FEMALE 4 - 100 PPM C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96057 C96058 C96059 C96060 108 97 103 131 133 123 97 118 106 107 97 SPILLED 119 SPILLED 118 106 99 99 129 137 122 100 118 105 112 96 132 120 SPILLED 116 WEEK 13 103 96 96 129 137 128 105 125 103 106 101 131 197 SPILLED 112 Covance 6329-225 3M T-6314.1 PAGE: 11 4 T 9 frOO i 214 I4 4 ? Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 1 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: MALE 2 - 3 PPM C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95931 C95932 C95933 C95934 C95935 C95936 C95937 C95938 C95939 C95940 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.2 0.3 0.3 0.3 0.3 0.3 0.3 0.4 0.3 0.3 0.3 0.3 0.3 0.3 SPILLED 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.2 0.3 0.3 0.3 0.3 0.3 0.3 GROUP : MALE 3 - 30 PPM C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 3.0 2.6 3.0 2.6 3.0 2.6 3.2 2.7 3.1 2.7 3.2 2.6 2.9 2.5 3.0 2.6 WEEK 3 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.3 0.2 2.2 2.2 2.3 2.4 2.4 2.4 2.2 2.5 WEEK 4 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 2.2 2.1 2.2 2.2 2.2 2.3 2.1 2.2 WEEK 5 WEEK 6 WEEK 7 WEEK 8 WEEK 9 WEEK 10 0.2 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.3 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 SPILLED 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.2 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.2 0.2 0.2 0.2 1.9 1.9 1.8 1.7 1.5 1.5 1.8 2.0 1.7 1.7 1.7 1.7 1.7 1.9 1.8 1.7 1.7 . 1.5 1.9 2.1 1.9 1.8 1.7 1.6 2.0 2.1 2.0 1.8 1.7 1.6 2.0 2.0 1.9 1.9 1.7 1.6 1.7 1.9 1.7 1.6 1.5 1.4 1.9 1.9 1.8 1.8 1.7 1.6 004762 215 Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 2 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: MALE 3 - 3 0 PPM C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956 C95957 C95958 C95959 C95960 3.0 2.6 3.0 2.6 2.9 2.4 2.9 2.5 3.3 2.8 3.1 2.8 3.6 2.9 3.8 SPILLED 2.8 2.5 3.1 2.6 3.2 2.8 3.0 2.7 GROUP: MALE 4 - 100 PPM C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 C95971 C95972 C95973 C95974 C95975 C95976 10.2 9.9 10.2 10.1 10.3 10.2 10.6 11.6 10.4 9.5 10.0 10.1 11.3 10.4 9.8 10.4 8.7 8.8 8.5 9.4 9.1 9.0 9.1 9.3 8.6 9.3 8.6 8.7 9.6 9.3 8.5 9.1 WEEK 3 2.4 2.4 2.2 2.3 2.5 2.5 2.6 2.7 2.3 2.4 2.5 2.3 7.7 7.7 7.5 7.7 8.1 8.1 7.9 8.3 7.6 SPILLED 7.7 7.6 8.3 7.9 7.5 7.9 WEEK 4 WEEK 5 WEEK 6 WEEK 7 WEEK 8 WEEK 9 WEEK 10 2.2 1.8 2.0 1.9 1.8 1.7 1.6 2.1 1.8 2.0 1.9 1.8 1.8 1.6 2.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.3 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.4 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.5 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.6 SPILLED 2.5 2.3 SPILLED 1.9 1.9 2.1 2.0 1.9 1.8 1.7 1.6 1.5 2.2 2.0 2.1 1.8 1.8 1.8 1.7 2.4 2.2 2.2 2.0 2.0 1.9 1.8 2.3 2.1 1.8 1.8 1.7 1.6 1.5 7.2 6.0 6.7 6.2 5.9 5.6 5.2 7.2 6.3 6.9 6.5 6.0 5.9 5.6 6.9 6.2 6.6 6.1 5.9 5.7 5.3 7.6 6.3 6.5 6.4 6.0 5.7 5.4 7.6 6.6 7.1 6.5 6.1 6.0 5.6 7.4 6.2 6.9 6.5 6.1 6.0 5.9 7.3 6.1 6.6 6.5 6.1 5.9 5.7 7.8 6.4 6.9 6.5 5.3 5.2 6.0 7.1 5.8 6.5 6.2 5.9 5.6 5.4 7.2 6.2 6.8 6.2 6.0 5.5 5.4 6.4 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.9 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.9 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.4 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.3 6.7 6.6 6.4 6.0 5.8 5.3 004763 216 Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 3 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP : MALE 4 - 100 PPM C95977 C95978 C95979 C95980 10.0 9.9 10.6 10.2 9.0 8.4 9.0 8.9 GROUP: FEMALE 2 - 3 PPM C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C9609 C96010 C96011 C96012 C96013 C96014 C96015 C96016 C96017 C96018 C96019 C96020 SPILLED 0.3 0.3 0.4 0.3 SPILLED 0.3 0.4 0.3 0.3 0.3 0.3 SPILLED 0.3 0.3 0.3 0.3 0.3 0.3 SPILLED SPILLED 0.3 0.3 0.1 0.3 SPILLED 0.3 SPILLED SPILLED 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 WEEK 3 7.7 7.2 8.0 7.8 SPILLED 0.3 0.2 0.3 0.2 SPILLED 0.3 0.3 SPILLED 0.3 0.3 SPILLED 0.3 0.3 0.3 0.2 0.3 0.3 0.2 0.3 WEEK 4 7.4 6.8 7.3 7.1 SPILLED 0.3 0.2 SPILLED 0.2 SPILLED 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.2 0.2 SPILLED 0.2 0.2 WEEK 5 WEEK 6 WEEK 7 WEEK 8 WEEK 9 WEEK 10 6.7 6.7 6.5 6.1 6.0 5.6 6.4 6.1 5.9 5.8 5.8 5.6 7.1 6.4 6.4 5.9 5.8 5.6 6.8 6.6 6.5 6.2 5.9 5.7 SPILLED 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.3 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2 0.3 0.2 0.2 0.2 0.2 SPILLED 0.3 0.2 0.4 SPILLED NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2 SPILLED 0.2 SPILLED 0.2 0.3 0.2 0.2 0.2 0.3 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.3 0.2 SPILLED 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 004764 217 Appendix 4 Individual Test Material Consumption Data lmg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS covance 6329-225 3M T-6314.1 PAGE: 4 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP : FEMALE 3 - 30 PPM C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96031 C96032 C96033 C96034 C96035 C96036 C96037 C96038 C96039 C96040 SPILLED 3.1 2.8 3.0 3.1 SPILLED 5.0 3.1 3.4 3.5 3.4 3.2 3.0 3.9 3.4 2.9 3.2 3.0 4.7 SPILLED 4.4 SPILLED 2.7 2.6 2.7 SPILLED SPILLED 3.0 SPILLED 3.1 SPILLED 3.2 2.8 2.9 3.0 2.6 2.8 3.6 SPILLED SPILLED GROUP : FEMALE 4 - 100 PPM C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 12.7 8.2 9.5 10.6 9.7 SPILLED 9.3 10.6 9.1 6.8 8.3 8.7 9.4 SPILLED 8.6 8.2 WEEK 3 3.1 2.8 2.6 2.4 2.8 SPILLED 3.5 2.6 3.4 3.0 3.4 2.6 2.7 2.6 2.5 2.4 3.6 SPILLED SPILLED SPILLED 8.3 6.6 7.5 8.6 8.3 8.3 7.8 7.0 WEEK 4 2.8 2.7 2.6 2.4 2.5 SPILLED SPILLED 2.5 2.7 2.8 SPILLED 2.5 2.4 2.8 2.5 2.2 SPILLED SPILLED SPILLED SPILLED 8.7 6.6 7.3 8.5 9.4 8.0 7.1 7.3 WEEK 5 WEEK 6 WEEK 7 WEEK 8 WEEK 9 WEEK 10 2.6 SPILLED 2.1 2.1 2.2 SPILLED SPILLED 2.2 2.2 2.5 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 2.3 SPILLED SPILLED SPILLED 2.9 2.4 2.8 2.3 2.5 3.0 2.9 2.2 SPILLED 2.6 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.8 2.3 3.3 SPILLED SPILLED SPILLED 2.3 2.3 SPILLED 2.2 SPILLED SPILLED 2.3 SPILLED 2.6 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 2.3 SPILLED SPILLED SPILLED 2.3 2.0 2.4 2.2 2.3 SPILLED SPILLED 2.2 2.8 2.3 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.3 2.3 SPILLED 2.6 SPILLED SPILLED 2.1 2.2 1.9 2.3 SPILLED 2.4 2.2 SPILLED 2.3 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 2.1 SPILLED SPILLED 4.2 2.0 2.0 2.1 1.9 2.0 3.1 2.3 2.1 3.7 2.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 2.0 2.3 SPILLED SPILLED 7.6 8.8 8.0 7.4 7.1 7.0 6.4 6.7 6.6 6.6 6.2 5.7 6.9 7.2 6.8 6.5 6.6 6.6 7.6 7.9 7.1 7.7 7.2 6.7 7.8 8.8 8.2 7.9 8.1 7.5 7.5 7.7 SPILLED 8.1 7.8 6.4 7.2 7.3 7.0 7.2 6.6 6.4 6.4 6.9 6.4 6.8 6.8 6.7 004765 218 Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 5 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: FEMALE 4 - 1 0 0 PPM C96049 C96050 C96051 C96052 C96053 C96054 C96055 C96056 C96057 C96058 C96059 C96060 9.6 12.1 9.1 11.5 10.1 SPILLED 9.3 9.5 13.8 9.8 11.1 10.4 SPILLED SPILLED 8.8 9.0 8.9 SPILLED 8.4 8.5 9.2 9.1 12.0 8.8 WEEK 3 8.2 9.2 7.5 9.3 8.8 SPILLED 8.1 8.2 8.4 7.8 8.7 7.6 WEEK 4 WEEK 5 WEEK 67 WEEK 8 WEEK 9 WEEK WEEK 10 7.9 8.5 7.6 8.1 8.2 10.6 7.9 8.3 9.9 7.5 9.4 7.6 7.1 7.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.6 8.8 7.7 8.8 7.3 8.0 8.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.3 7.8 7.3 8.7 6.7 7.4 7.6 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.7 7.3 7.4 8.6 7.3 7.8 7.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.0 7.3 7.0 SPILLED 6.8 7.7 7.3 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.4 6.7 6.7 SPILLED 6.8 7.2 6.9 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.4 7.2 7.1 SPILLED 6.2 004766 219 004767 Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 WEEK 13 GROUP: MALE 2 - 3 PPM C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95931 C95932 C95933 C95934 C95935 C95936 C95937 C95938 C95939 C95940 0.2 0.2 0.2 0.2 0.2 0.1 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.1 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.1 0.2 0.2 0.2 GROUP: MALE 3 - 3 0 PPM C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 1.5 1.7 1.5 1.5 1.6 SPILLED 1.3 1.6 1.4 1.7 1.5 1.5 1.5 1.5 1.3 1.5 0.2 0.1 0.1 0.2 0.2 0.1 0.1 0.1 0.1 0.1 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.2 0.1 0.1 0.1 1.3 1.7 1.4 1.4 1.6 1.4 1.3 1.5 220 Covance 6329-225 3M T-6314.1 PAGE: 6 I 004 768 Appendix 4 Individual Test Material Consumption Data mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 WEEK 13 GROUP: MALE 3 - 3 0 PPM C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956 C95957 C95958 C95959 C95960 1.5 1.7 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 1.9 1.5 1.6 1.7 1.5 1.4 1.7 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 1.8 1.5 1.6 1.7 1.5 GROUP : MALE 4 - 100 PPM C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 C95971 C95972 C95973 C95974 C95975 C95976 5.0 5.2 5.4 5.4 5.5 5.5 5.6 6.1 5.1 5.1 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 5.0 5.2 5.3 5.3 5.5 5.3 5.4 6.0 5.0 5.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 5.1 0.1 1.6 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 1.6 1.4 1.5 1.6 1.4 4.9 4.8 4.9 5.2 5.4 4.9 5.0 5.1 4.9 4.8 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 5.1 221 Covance 6329-225 3M T-6314.1 PAGE: 7 if I Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 WEEK 13 GROUP: MALE 4 - 1 0 0 PPM C95977 C95978 C95979 C95980 5.5 5.3 5.2 5.2 5.3 5.4 5.6 5.5 GROUP: FEMALE 2 - 3 PPM C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 C96011 C96012 C96013 C96014 C96015 C96016 C96017 C96018 C96019 C96020 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 SPILLED 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 5.0 5.0 5.3 5.4 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 SPILLED 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 SPILLED 0.2 0.2 Covance 6329-225 3M T-6314.1 PAGE: 8 04769 222 i 004770 Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 WEEK 13 GROUP; FEMALE 3 - 30 PPM C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96031 C96032 C96033 C96034 C96035 C96036 C96037 C96038 C96039 C96040 3.3 2.0 2.0 1.9 2.0 SPILLED 2.7 1.8 SPILLED 2.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 2.1 2.1 3.1 SPILLED 2.1 1.8 1.9 1.9 1.7 4.2 2.5 1.8 3.0 2.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.0 2.0 2.0 2.6 3.1 GROUP : FEMALE 4 - 100 PPM C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 6.8 6.5 5.7 5.7 6.2 5.9 6.7 6.5 7.0 7.2 6.3 6.1 6.2 6.3 6.9 6.9 2.1 1.9 1.9 1.8 1.8 3.7 2.0 1.8 SPILLED 2.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 3.3 2.1 1.9 2.4 SPILLED 6.3 5.5 5.7 6.5 7.1 6.4 6.6 7.1 223 Covance 6329-225 3M T-6314.1 PAGE: 9 i i 4 \t Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 11 WEEK 12 WEEK 13 GROUP: FEMALE 4 - 100 PPM C96049 C96050 C96051 C96052 C96053 C96054 C9605S C96056 C96057 C96058 C96059 C96060 7.4 6.7 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.1 SPILLED 6.6 SPILLED 6.3 7.2 6.9 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.1 6.9 6.5 SPILLED 6.1 7.0 6.4 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.3 6.7 10.4 SPILLED 5.9 Covance 6329-225 3m T-6314.1 PAGE: 10 004771 224 t APPENDIX 5 Individual Clinical Hematology Data Individual Clinical Chemistry Data Individual Clinical Urinalysis Data Covance 6329-225 3M T-6314.1 32S. 004772 Appendix 5 Individual Clinical Hematology Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL RBC HGB HCT MCV MCH MCHC PLT NUMBER XIOV^L G/DL % FL PG % X10 /*<L Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 MEAN S.D. N Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 MEAN S.D. N Dose Level : 0 8.89 8.64 8.23 7.52 7.92 7.90 8.18 7.86 8.63 8.06 17.3 16.6 16.4 15.3 15.3 15.7 16.3 16.0 17.0 16.1 8.18 .424 10 16.2 .66 10 Dose Level : 3 8.38 7.84 8.57 7.55 8.09 8.29 8.07 8.99 7.76 7.89 16.8 15.6 17.0 16.3 16.2 16.0 16.2 17.1 16.1 16.4 8.14 .427 10 16.4 .47 10 Dosage Unit: ppm MeFOS 50.1 48.1 47.5 45.5 42.7 46.2 46.7 47.4 49.1 46.3 56.4 55.7 57.6 60.5 54.0 58.5 57.1 60.3 56.9 57.4 19.4 19.2 19.9 20.4 19.3 19.8 19.9 20.4 19.7 20.0 47.0 2.04 10 57.4 1.97 10 19.8 .42 10 Dosage Unit: ppm MeFOS 49.2 45.6 48.6 46.8 46.7 46.2 47.9 51.1 46.0 47.1 58.7 58.2 56.8 61.9 57.7 55.8 59.3 56.8 59.3 59.7 20.0 19.9 19.9 21.5 20.1 19.3 20.0 19.0 20.8 20.7 47.5 1.70 10 58.4 1.77 10 20.1 .73 10 34.5 34.6 34.6 33.7 35.7 33.9 34.9 33.7 34.7 34.7 34.5 .61 10 34.1 34.2 35.0 34.7 34.8 34.6 33.8 33.5 35.0 34.7 34.4 .51 10 1186 1223 1208 1227 1235 1221 1084 1086 1099 1162 1173 61.5 10 1136 1297 1400 1177 1108 1172 1166 1143 917 993 1151 136.0 10 Covance 6329-225 3M T-6314.1 ^ < 1^00 226 Appendix 5 Individual Clinical Hematology Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS ANIMAL RBC HGB HCT MCV MCH MCHC PLT NUMBER XIOVm L G/DL % FL PG % XlOV^tL Group: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 MEAN S.D. N Dose Level : 30 8.09 9.02 8.19 8.23 8.17 7.68 8.10 8.37 9.01 7.56 16.1 16.9 15.9 16.7 16.2 16.2 16.0 16.6 16.7 15.8 8.24 .477 10 16.3 .38 10 Dose Level : 100 7.59 8.16 8.03 7.64 8.33 8.11 8.32 7.57 7.90 8.29 15.7 16.0 16.1 16.1 16.9 15.3 16.1 14.9 14.8 16.8 7.99 .303 10 15.9 .71 10 Dosage Unit: ppm MeFOS 45.9 49.9 45.9 48.2 46.5 46.0 45.3 47.7 49.4 45.8 56.7 55.3 56.1 58.6 56.9 59.9 55.9 56.9 54.8 60.6 19.9 18.7 19.4 20.2 19.8 21.1 19.8 19.9 18.6 20.9 47.1 1.64 10 57.2 1.93 10 19.8 .81 10 Dosage Unit: ppm MeFOS 46.0 46.4 46.9 46.1 48.7 44.6 46.9 43.2 43.9 47.7 60.6 56.9 58.5 60.3 58.5 55.0 56.3 57.1 55.6 57.5 20.7 19.6 20.1 21.1 20.2 18.9 19.4 19.7 18.7 20.3 46.0 1.71 10 57.6 1.86 10 19.9 .76 10 35.1 33.9 34.6 34.5 34.9 35.2 35.4 34.9 33.9 34.4 34.7 .52 10 34.1 34.5 34.4 34.9 34.6 34.4 34.4 34.4 33.6 35.3 34.5 .45 10 1130 1133 1027 891 1074 893 1151 1027 958 1098 1038 96. 10 1141 1097 1177 986 1166 948 1001 1296 1032 970 1081 112. 10 Covance 6329-225 3M T-6314.1 004774 227 ANIMAL NUMBER WBC X103/jL Appendix 5 Individual Clinical Hematology Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH X103/aiL XIO'/^L MONO EOSIN X103/^L x i o 3/^l BASO N-SEG% x i o /m l LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% Group: 1 Dose Level: 0 Dosage Unit: ppm MeFOS C95901 B .6 .5 7.7 .4 .1 .0 6 89 4 1 0 C95902 9.7 .6 8.6 .4 .0 .0 6 89 5 0 0 C95903 6.7 .8 5.7 .2 .1 .0 11 85 3 1 0 C95904 11.9 .4 10.7 .7 .1 .0 3 90 6 1 0 C95905 8.4 .6 7.3 .3 .1 .0 8 87 4 1 0 C95906 6.9 .5 6.0 .3 .1 .0 7 87 4 1 0 C95907 8.1 .5 7.1 .4 .1 .0 6 88 5 1 1 C9590B 12.7 .8 11.4 .4 .1 .0 6 90 3 1 0 C95909 8.1 .7 6.8 .5 .1 .0 9 84 6 1 0 C95910 9.5 .7 8.1 .6 .1 .0 7 85 7 1 0 MEAN S.D. N 9.1 .6 7.9 .4 .1 .0 7 87 5 1 0 1.96 .14 1.86 .15 .03 .00 2.1 2.2 1.3 .3 .3 10 10 10 10 10 10 10 10 10 10 10 Group : 2 Dose Level : 3 Dosage Unit : ppm MeFOS C95921 8.4 .5 7.5 .4 .1 .0 6 88 4 1 0 C95922 7.9 .6 6.6 .5 .2 .0 7 84 6 3 0 C95923 9.3 .6 8.2 .5 .1 .0 6 88 5 1 0 C95924 8.5 .6 7.2 .5 .1 .0 8 85 6 1 0 C95925 9.8 .5 8.9 .3 .1 .0 5 91 3 1 0 C95926 12.6 .7 10.9 .9 .1 .0 5 86 7 1 0 C95927 8.6 .7 7.2 .5 .1 .0 8 84 6 2 0 C95928 7.3 .4 6.8 .1 .0 .0 5 93 1 1 0 C95929 7.4 .7 6.2 .4 .1 .0 9 84 6 1 0 C95930 11.5 .5 10.6 .4 .1 .0 4 92 3 1 0 MEAN S.D. N 9.1 .6 8.0 .4 .1 .0 6 88 5 1 0 1.74 .10 1.64 .20 .05 .00 1.6 3.5 1.9 .7 .0 10 10 10 10 10 10 10 10 10 10 10 004775 228 ANIMAL NUMBER WBC X103/^L Appendix 5 Individual Clinical Hematology Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH XlO'/^L X10j/a<L MONO EOS IN XIO'/m L XIO'/^L BASO N-SEG% XIO'/^L LYMPH% MONO* EOSIN% Covance 6329-225 3M T-6314.1 BASO% Group: 3 Dose Level : 30 Dosage Unit: ppm MeFOS C95941 14.3 .8 12.8 .5 .2 .0 6 89 4 1 0 C95942 8.4 .4 7.6 .3 .0 .0 5 90 4 1 0 C95943 6.6 .4 5.8 .3 .1 .0 7 87 5 1 0 C95944 10.1 .5 9.2 .4 .1 .0 5 91 4 10 C95945 7.3 .6 6.4 .3 .1 .0 8 88 4 1 0 C95946 9.8 .3 9.1 .3 .1 .1 3 92 3 1 1 C95947 12.0 .7 10.7 .4 .1 .1 6 89 4 1 1 C95948 13.2 .6 12.0 .4 .1 .0 4 92 3 1 0 C95949 9.1 .5 8.2 .3 .0 .0 5 90 4 0 0 C95950 9.5 .5 8.3 .7 .1 .0 5 87 7 1 0 MEAN S.D. N 10.0 .5 9.0 .4 .1 .0 5 90 4 1 0 2.48 .15 2.27 .13 .06 .04 1.,4 1..8 1.,1 3 .4 10 10 10 10 10 10 10 10 10 10 10 Group: 4 Dose Level : 100 Dosage Unit: ppm MeFOS C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 14.4 .5 13.2 .6 .1 .1 3 92 10.2 1.0 8.4 .7 .1 .1 10 82 10.1 .5 8.9 .6 .1 .0 5 88 9.8 .8 8.5 .4 .1 .0 8 86 6.4 .7 5.2 .4 .1 .0 11 82 14.0 1.4 11.6 .8 .2 .0 10 83 4.2 .5 3.3 .3 .1 .0 12 79 14.7 1.1 12.7 .7 .1 .1 7 86 13.4 1.5 10.8 .9 .1 .0 12 80 9.8 1.4 7.8 .4 .1 .0 15 79 40 71 61 41 61 61 81 51 71 51 1 1 0 0 0 0 0 1 0 0 MEAN S.D. N 10.7 .9 9.0 .6 .1 .0 9 84 6 1 0 3.51 .40 3.17 .20 .03 .05 3. 6 4. 2 1. 3 3 10 10 10 10 10 10 10 10 10 10 10 004776 229 I Appendix 5 Individual Clinical Hematology Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 Dose Level : 0 Dose Level: 3 --------------------- Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS ----------- Covance 6329-225 3M T-6314.1 ( fI i . I. 14 004777 230 I I, Appendix 5 Individual Clinical Hematology Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 Dose Level: 30 - ----- Dosage Unit: ppm MeFOS --- Dose Level: 100 Dosage Unit: ppm MeFOS ------------------------------------- ----- Covance 6329-225 3M T-6314.1 004778 231 i Appendix 5 Individual Clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL RBC HGB HCT MCV MCH MCHC PLT NUMBER XIOV/iL G/DL % FL PG % x i o V m l Group: 1 C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 MEAN S.D. N Dose Level : 0 7.36 7.74 7.53 7.56 7.75 8.17 7.75 7.67 7.63 7.82 15.2 15.7 16.2 14.5 15.8 15.9 15.8 15.5 15.7 16.3 7.70 .214 10 15.7 .51 10 Dose Level: 3 8.35 8.59 8.09 6.82 8.04 8.26 7.89 7.97 7.86 8.42 15.9 16.2 16.3 14.3 16.3 16.1 16.3 16.3 16.1 16.2 8.03 .488 10 16.0 .61 10 Dosage Uni t : ppm MeFOS 44.3 45.1 46.0 42.6 45.9 47.0 45.5 44.8 46.1 46.9 60.3 58.3 61.1 56.4 59.3 57.5 58.8 58.4 60.4 60.0 20.7 20.3 21.5 19.1 20.4 19.5 20.4 20.2 20.6 20.9 45.4 1.31 10 59.1 1.45 10 20.4 .68 10 Dosage Unit: ppm MeFOS 45.1 47.2 47.7 40.9 47.4 46.7 46.5 45.6 46.1 48.3 54.0 54.9 58.9 60.0 59.0 56.5 59.0 57.3 58.7 57.4 19.1 18.8 20.2 21.0 20.3 19.5 20.7 20.4 20.5 19.2 46.1 2.08 10 57.6 1.95 10 20.0 .76 10 34.3 34.8 35.2 33.9 34.4 33.9 34.7 34.5 34.1 34.9 34.5 .43 10 35.3 34.3 34.2 35.1 34.5 34.5 35.1 35.7 34.9 33.5 34.7 .64 10 1230 1254 1094 1137 1012 1085 913 1190 1056 1171 1114 104. 10 1297 1181 1107 1267 1139 1166 1106 1303 1083 1129 1178 82. 10 Covance 6329-225 3M T-6314.1 004779 232 Appendix 5 Individual Clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL RBC HGB HCT MCV MCH MCHC PLT NUMBER X106/^L G/DL % FL PG % XIO'/^L Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 MEAN S.D. N Group: 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 MEAN S.D. N Dose Level: 30 8.61 7.97 7.34 8.01 8.17 7.78 7.86 7.66 8.04 8.36 16.6 16.0 15.2 16.2 15.7 16.0 16.3 15.3 15.6 16.9 7.98 .357 10 16.0 .55 10 Dose Level: 100 7.44 7.66 8.63 7.63 8.13 7.84 7.91 7.76 7.95 7.95 14.5 15.1 16.5 15.3 15.7 15.7 15.8 15.1 15.2 15.7 7.89 .326 10 15.5 .54 10 Dosage Unit: ppm MeFOS 48.3 45.7 43.4 46.3 45.2 45.2 46.6 43.5 44.5 49.3 56.1 57.4 59.1 57.8 55.4 58.2 59.3 56.8 55.4 58.9 19.3 20.1 20.7 20.2 19.2 20.6 20.7 20.0 19.5 20.2 45.8 1.91 10 57.4 1.48 10 20.0 .56 10 Dosage Unit: ppm MeFOS 41.9 43.1 47.5 44.9 45.9 46.0 43.4 44.1 44.9 44.8 56.4 56.2 55.1 58.8 56.5 58.7 54.9 56.8 56.4 56.3 19.5 19.7 19.1 20.1 19.3 20.0 19.9 19.5 19.2 19.8 44.7 1.62 10 56.6 1.28 10 19.6 .34 10 34.4 35.0 35.1 35.0 34.8 35.5 35.0 35.3 35.1 34.3 35.0 .37 10 34.6 35.1 34.6 34.2 34.2 34.0 36.3 34.4 34.0 35.2 34.7 .71 10 1199 1084 1037 1029 1082 1124 1057 1414 1199 1007 1123 121. 10 1007 1191 1235 1059 1091 535 1151 1333 942 1032 1058 217. 10 Covance 6329-225 3M T-6314.1 004780 233 ANIMAL NUMBER WBC X103/a*L Appendix 5 Individual Clinical Hematology Data Females Meek 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH X10j/aaL X I O V m L MONO EOS IN XIO'/aaL X103/aaL BASO N-SEG% XIO'/aaL LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% Group: 1 Dose Level : 0 Dosage Unit: ppm MeFOS C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 8.2 1.1 6.4 .6 .1 .0 14 77 8 1 0 7.6 .7 6.3 .5 .1 .0 9 83 6 1 1 5.3 .4 4.6 .2 .0 .0 7 88 5 1 0 7.3 .2 6.8 .3 .0 .0 3 93 4 1 0 7.6 .5 6.6 .4 .1 .0 7 87 5 1 0 6.8 .2 6.3 .2 .0 .0 4 92 3 1 0 3.3 .2 2.9 .1 .0 .0 7 89 3 1 0 6.9 .5 5.9 .3 .1 .0 7 87 5 2 0 5.2 .3 4.5 .3 .0 .0 7 87 5 1 0 4.6 .2 4.1 .3 .0 .0 4 89 6 1 0 MEAN S.D. N 6.3 .4 5.4 .3 .0 .0 7 87 5 1 0 1.59 .29 1.32 .15 .05 .00 3..1 4.,5 1.,5 .3 10 10 10 10 10 10 10 10 10 10 10 Group: 2 Dose Level : 3 Dosage Unit: ppm MeFOS C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 5.7 .5 5.1 .1 .1 .0 9 88 3.5 .3 3.0 .1 .0 .0 9 86 7.6 .7 6.3 .4 .2 .0 10 83 7.2 .3 6.5 .4 .1 .0 4 90 11.1 .3 10.6 .2 .0 .0 2 96 5.8 .4 5.0 .3 .0 .0 6 88 10.4 .4 9.7 .3 .1 .0 4 93 7.0 .4 6.2 .3 .1 .0 5 89 7.9 .8 6.6 .3 .1 .0 10 84 7.4 .8 6.4 .1 .0 .0 11 86 11 41 52 51 10 51 31 51 42 20 0 0 0 0 0 0 0 0 0 0 MEAN S.D. N 7.4 .5 6.5 .2 .1 .0 7 88 4 1 0 2.21 .20 2.20 .12 .07 .00 3. 2 4. 0 1, 6 7 10 10 10 10 10 10 10 10 10 10 10 004781 234 ANIMAL NUMBER WBC XIO'/xL Appendix 5 Individual Clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE , T-6314) IN RATS N-SEG LYMPH XIOVm L xioV ^ l MONO xioV^l EOSIN X103/aiL BASO N-SEG% X10 V/iL LYMPH% MONO% EOSINt Covance 6329-225 3M T-6314.1 BASO% Group: 3 Dose Level: 30 Dosage Unit: ppm MeFOS C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 7.7 .3 7.0 .2 .1 .0 4 92 31 0 6.2 .3 5.6 .3 .0 .0 4 90 4 1 0 5.1 .8 3.8 .4 .1 .0 16 74 82 0 5.9 .4 5.2 .2 .1 .0 7 88 3 1 0 5.7 .3 5.2 .2 .1 .0 5 90 3 1 0 9.7 .5 8.8 .2 .1 .0 6 91 2 1 0 10.9 .6 9.6 .7 .1 .0 5 88 6 1 0 6.7 .4 5.9 .3 .0 .0 6 88 5 1 0 4.4 .7 3.6 .1 .0 .0 15 81 3 1 0 11.1 .7 9.6 .6 .1 .0 7 87 51 0 MEAN S.D. N 7.3 .5 6.4 .3 .1 .0 8 87 4 1 0 2.42 .19 2.24 .19 .05 .00 4.4 5.4 1.8 .3 .0 10 10 10 10 10 10 10 10 10 10 10 Group: 4 Dose Level: 100 Dosage Unit: ppm MeFOS C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 10.2 .3 9.6 .3 .1 .0 3 94 2 6.7 .4 5.9 .3 .1 .0 7 88 4 8.9 .5 7.9 .4 .1 .0 6 88 5 6.6 .8 5.4 .3 .1 .0 12 82 4 10.8 .4 9.1 1.1 .1 .1 4 84 10 5.7 .2 5.2 .2 .0 .0 3 92 4 6.6 .4 5.8 .3 .1 .0 6 88 4 5.7 .7 4.8 .2 .1 .0 12 84 3 7.3 .4 6.7 .2 .0 .0 5 91 3 4.2 .5 3.4 .3 .1 .0 12 80 7 1 1 1 2 1 1 1 1 1 1 0 0 0 0 1 0 0 0 0 0 MEAN S.D. N 7.3 .5 6.4 .4 .1 .0 7 87 5 1 0 2.09 .18 1.96 .27 .04 .03 3.7 4.5 2.3 .3 .3 10 10 10 10 10 10 10 10 10 10 10 004782 235 Appendix 5 Individual Clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 1 C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C9601Q Dose Level: 0 ------------------- Dose Level: 3 --------------------- Dosage Unit: ppm MeFOS -------- --- Dosage Unit: ppm MeFOS ----------- Covance 6329-225 3M T-6314.1 i [, Ji, i ^ 004783 236 Ii Appendix 5 Individual Clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 Group: 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 Dose Level: 30 ------___ ------------- Dose Level: 100 --------------------- Dosage Unit: ppm MeFOS ---__ ------- Dosage Unit: ppm MeFOS ----------- Covance 6329-225 3M T-6314.1 004784 237 Appendix 5 individual Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL RBC HGB HCT MCV MCH MCHC PLT NUMBER XIOV^L G/DL % FL PG % X103/a<L Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 MEAN S.D. N Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 MEAN S.D. N Dose Level : 0 9.37 8.66 9.11 7.96 8.19 8.16 8.63 8.25 8.36 8.96 16.2 15.1 16.1 14.8 14.3 14.4 15.7 14.8 15.3 16.1 8.56 .463 10 15.3 .71 10 Dose Level : 3 8.71 8.33 7.14 8.57 8.91 9.13 9.29 8.05 8.34 7.72 15.4 15.3 14.2 15.4 15.4 16.5 16.0 15.0 14.9 14.5 8.42 .657 10 15.3 .67 10 Dosage Unit: ppm MeFOS 49.4 46.4 49.9 45.9 43.7 45.5 48.0 45.7 46.3 49.0 52.7 53.5 54.7 57.6 53.3 55.7 55.6 55.4 55.4 54.7 17.3 17.5 17.6 18.5 17.4 17.7 18.2 17.9 18.3 17.9 47.0 2.00 10 54.9 1.43 10 17.8 .40 10 Dosage Unit: ppm MeFOS 47.4 46.0 43.1 47.6 47.1 50.0 49.2 45.8 45.9 44.9 54.4 55.2 60.4 55.6 52.9 54.8 53.0 57.0 55.0 58.1 17.7 18.3 19.8 17.9 17.3 18.1 17.2 18.7 17.9 18.7 46.7 2.02 10 55.6 2.31 10 18.2 .77 10 32.9 32.6 32.2 32.2 32.7 31.7 32.7 32.3 33.0 32.8 32.5 .40 10 32.5 33.2 32.9 32.3 32.7 33.0 32.5 32.8 32.5 32.2 32.7 .32 10 1131 1142 1001 1130 1174 1148 935 1072 1095 1390 1122 119. 10 1019 1225 1042 1038 1115 1124 1028 988 1003 1019 1060 73. 10 Covance 6329-225 3M T-6314.1 S8?00 238 Appendix 5 Individual Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL RBC HGB HCT MCV MCH MCHC PLT NUMBER XIOVm L G/DL % FL PG XIO'/^L Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 MEAN S.D. N Dose Level : 30 8.33 9.62 8.89 8.53 9.15 9.24 8.68 8.26 8.07 8.03 14.7 16.0 15.4 15.5 15.2 16.1 14.6 15.4 14.4 15.2 8.68 .535 10 15.2 .56 10 Dose Level : 100 8.07 8.58 8.15 7.96 8.54 8.41 8.44 7.75 8.14 8.42 14.7 14.9 14.6 14.4 15.8 14.9 14.3 13.0 14.6 15.0 8.25 .273 10 14.6 .71 10 Dosage Unit: ppm MeFOS 44.1 50.5 47.2 47.5 47.1 49.0 46.3 45.6 44.2 46.1 53.0 52.5 53.2 55.7 51.5 53.0 53.4 55.2 54.8 57.5 17.7 16.6 17.4 18.2 16.6 17.4 16.8 18.7 17.9 18.9 46.8 1.99 10 54.0 1.79 10 17.6 .82 10 Dosage Unit: ppm MeFOS 44.6 45.4 44.6 43.4 47.0 45.2 43.6 39.7 43.8 45.3 55.3 52.9 54.8 54.6 55.1 53.7 51.7 51.2 53.8 53.9 18.3 17.4 17.9 18.1 18.5 17.7 17.0 16.7 17.9 17.8 44.3 1.92 10 53.7 1.39 10 17.7 .56 10 33.3 31.6 32.7 32.7 32.3 32.9 31.6 33.9 32.6 33.0 32.7 .71 10 33.0 32.8 32.7 33.3 33.6 33.0 32.8 32.7 33.3 33.1 33.0 .30 10 1015 1065 1109 932 1107 1006 636 986 1100 1045 1000 140. 10 957 992 1153 1014 1104 907 1306 902 878 897 1011 138. 10 Covance 6329-225 3M T-6314.1 239 ANIMAL NUMBER WBC Xl0V/iL Appendi X 5 Individual Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH XIO'/^L X10J/<L MONO EOSIN X103/aL X I O V m I BASO N-SEG% XIOV/L LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% Group: 1 Dose Level: 0 Dosage Unit: ppm MeFOS C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 7.5 .8 6.0 .6 .1 .0 11 80 7 1 0 6.0 .9 4.8 .2 .0 .0 15 81 4 1 0 6.8 1.2 4.9 .6 .1 .0 17 72 9 2 0 6.0 .7 4.8 .5 .1 .0 11 79 8 2 0 6.4 .6 5.3 .3 .1 .0 10 82 5 2 0 6.0 1.0 4.4 .5 .1 .0 16 74 8 2 1 6.9 1.0 5.2 .6 .1 .0 15 75 9 1 0 7.0 .6 5.7 .6 .1 .0 8 82 8 1 1 8.8 .8 7.4 .4 .1 .0 10 84 5 2 0 7.4 1.5 5.4 .4 .1 .0 21 73 5 1 0 MEAN S.D. N 6.9 .9 5.4 .5 .1 .0 13 78 7 2 0 .88 .28 .85 .14 .03 .00 4.0 4.3 1.9 .5 10 10 10 10 10 10 10 10 10 10 10 Group: 2 Dose Level : 3 Dosage Uni t : ppm MeFOS C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 4.8 .8 3.6 .3 .1 .0 16 76 6 2 0 7.0 1.1 5.0 .6 .2 .0 16 72 9 3 0 7.7 .9 6.4 .4 .1 .0 12 83 5 1 0 6.1 1.4 4.2 .4 .1 .0 23 69 6 1 0 8.0 1.3 5.9 .6 .2 .0 16 73 8 2 0 6.4 .8 5.1 .3 .2 .0 12 80 5 2 0 6.0 1.0 4.0 .8 .1 .0 17 66 14 2 1 7.2 .9 5.7 .4 .2 .0 13 80 5 2 0 4.3 .7 3.2 .2 .1 .0 17 75 5 2 0 9.2 1.1 7.5 .5 .1 .0 12 81 6 1 0 MEAN S.D. N 6.7 1.0 5.1 .4 .1 .0 15 76 7 2 0 1.48 .23 1.35 .18 .05 .00 3.4 5.6 2.8 .6 10 10 10 10 10 10 10 10 10 10 10 004787 240 ! ANIMAL NUMBER Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 MEAN S.D. N WBC XIO'/m L Appendix 5 Individual Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL :PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE , T-6314) IN RATS N-SEG LYMPH X103/>iL x i o V m l MONO x i o '/k l EOSIN XlO'/^iL BASO N-SEG% X10V/iL LYMPH% MONO EOSIN Covance 6329-225 3M T-6314.1 BASO Dose Level : 30 Dosage Unit: ppm MeFOS 10.8 1.2 9.0 .4 .1 .0 11 84 3 1 0 3.7 .7 2.8 .1 .0 .0 20 76 3 1 0 7.9 .8 6.4 .5 .1 .0 10 82 7 1 0 6.1 .7 4.9 .4 .1 .0 11 81 6 2 0 12.0 .9 10.6 .3 .1 .0 8 88 3 1 0 10.8 .7 9.5 .5 .1 .0 6 88 4 1 0 7.4 1.3 5.3 .6 .1 .0 18 72 9 1 0 5.9 .9 4.5 .4 .1 .0 15 76 7 2 0 6.2 1.1 4.6 .3 .2 .0 18 74 5 3 0 6.0 .6 4.9 .4 .1 .0 10 82 6 1 0 7.7 .9 6.2 .4 .1 .0 13 80 5 1 0 2.68 .24 2.57 .14 .05 .00 4.7 5.6 2..1 .7 .0 10 10 10 10 10 10 10 10 10 10 10 Dose Level : 100 Dosage Unit: ppm MeFOS 5.0 .8 3.9 .2 .1 .0 17 77 4 1 0 5.9 1.0 4.6 .3 .1 .0 16 77 5 1 0 8.8 1.0 7.4 .3 .1 .0 11 84 3 2 0 6.7 1.2 5.0 .4 .1 .0 18 74 6 1 0 5.4 1.1 4.0 .2 .1 .0 20 74 4 1 0 4.4 .7 3.3 .4 .0 .0 15 75 8 1 0 12.7 1.6 10.0 1.0 .2 .1 12 78 8 1 1 10.3 1.8 7.8 .4 .1 .0 18 76 4 1 0 5.9 .8 4.6 .3 .1 .0 14 79 6 1 0 6.6 1.1 5.0 .4 .1 .0 16 76 6 2 0 7.2 1.1 5.6 .4 .1 .0 16 77 5 1 0 2.63 .35 2.13 .23 .05 .03 2.8 2.9 1. 7 4 .3 10 10 10 10 10 10 10 10 10 10 10 f / l rt!, i 004788 241 i Appendix 5 Individual Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 Dose Level: 0 ___ ___ ___ ___ ___ ___ Dose Level: 3 ___ ___ ___ ___ ___ ___ ___ - Dosage Unit: ppm MeFOS __ __ __ __ __ __ Dosage Unit: ppm MeFOS __ __ __ __ __ __ __ Covance 6329-225 3M T-6314.1 004789 242 i Appendix 5 Individual Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 Dose Level: 30 --------------------- Dose Level: 100 --------------------- Dosage Unit: ppm MeFOS ----------- Dosage Unit: ppm MeFOS ----------- Covance 6329-225 3M T-6314.1 o 04790 243 Appendix 5 Individual Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL RBC HGB HCT MCV MCH MCHC PLT NUMBER XlOV/iL G/DL % FL PG XloV/iL Group: 1 C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 MEAN S.D. N Dose Level : 0 7.70 8.09 7.55 7.54 7.59 7.77 7.85 7.80 7.78 7.96 15.1 14.8 14.6 14.2 14.6 14.7 14.6 14.3 14.8 15.8 7.76 .178 10 14.8 .45 10 Dose Level : 3 8.33 8.06 7.54 7.77 8.34 7.73 8.55 8.13 8.18 14.6 14.9 14.4 14.5 16.6 14.3 15.8 15.1 15.3 8.07 .330 9 15.1 .75 9 Dosage Unit: ppm MeFOS 46.1 45.7 44.9 43.4 44.9 44.7 45.0 44.5 45.0 46.9 59.9 56.5 59.4 57.6 59.1 57.6 57.4 57.0 57.8 58.9 19.7 18.2 19.3 18.8 19.2 18.9 18.6 18.3 19.0 19.8 45.1 .95 10 58.1 1.13 10 19.0 .54 10 Dosage Unit: ppm MeFOS 45.4 44.6 44.8 44.3 49.8 43.9 48.0 46.8 46.9 54.5 55.4 59.4 57.0 59.7 56.8 56.1 57.6 57.4 17.5 18.5 19.1 18.7 19.9 18.5 18.5 18.5 18.7 46.1 1.97 9 57.1 1.70 9 18.7 .63 9 32.8 32.3 32.5 32.6 32.5 32.9 32.5 32.2 32.9 33.6 32.7 .40 10 32.1 33.4 32.1 32.8 33.3 32.6 33.0 32.2 32.5 32.7 .49 9 940 1026 894 1107 848 1087 1098 1163 951 1049 1016 103. 10 1176 1045 938 965 1108 1055 1142 1263 969 1073 108. 9 Covance 6329-225 3M T-6314.1 T6fc00 244 Appendix 5 Individual Clinical Hematology Data Females Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL RBC HGB HCT MCV MCH MCHC PLT NUMBER X10`/aL G/DL % FL PG % XloV/iL Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 MEAN S.D. N Group : 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 MEAN S.D. N Dose Level : 30 8.56 8.45 7.78 7.76 8.49 7.62 8.33 8.05 7.86 7.99 15.4 15.9 15.0 14.5 15.3 14.6 15.7 15.6 14.2 15.1 8.09 .343 10 15.1 .56 10 Dose Level : 100 7.74 7.55 8.20 7.75 7.33 7.47 8.10 7.41 7.52 7.80 13.9 14.0 15.1 15.0 13.0 14.0 14.7 13.7 13.8 14.8 7.69 .289 10 14.2 .67 10 Dosage Unit: ppm MeFOS 47.5 48.2 45.5 44.2 46.7 44.9 48.4 47.8 43.3 45.7 55.5 57.1 58.5 57.0 55.1 58.9 58.2 59.4 55.1 57.2 18.0 18.9 19.3 18.6 18.1 19.1 18.8 19.4 18.0 18.9 46.2 1.77 10 57.2 1.57 10 18.7 .52 10 Dosage Unit: ppm MeFOS 42.7 43.3 45.7 44.7 39.9 42.3 44.6 41.4 41.5 45.3 55.1 57.4 55.7 57.7 54.4 56.6 55.1 55.9 55.2 58.1 18.0 18.6 18.5 19.4 17.7 18.7 18.1 18.6 18.4 19.0 43.1 1.91 10 56.1 1.26 10 18.5 .49 10 32.4 33.0 32.9 32.7 32.8 32.5 32.4 32.7 32.7 33.0 32.7 .22 10 32.6 32.4 33.1 33.6 32.6 33.1 32.9 33.2 33.3 32.8 33.0 .37 10 931 1017 1047 915 1079 918 1059 809 905 1117 980 97. 10 1203 945 965 1049 1088 1189 988 925 1210 995 1056 110. 10 Covance 6329-225 3M T-6314.1 004792 245 ANIMAL NUMBER WBC XIO'/^L Appendix 5 Individual Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS N-SEG LYMPH X I O V aiL XIO'/aiL MONO EOSIN X103/a<L X103/aiL BASQ N-SEG% X 1 0 V a<L LYMPH MONO EOSIN Covance 6329-225 3M T-6314.1 BASO Group: 1 Dose Level: 0 Dosage Unit: ppm MeFOS C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 4.2 1.0 3.1 .0 .1 .0 24 74 1 2 0 2.3 .3 1.9 .1 .0 .0 12 82 4 2 0 4.9 1.9 2.6 .3 .1 .0 39 53 7 1 0 4.8 .7 4.0 .0 .1 .0 15 82 0 2 0 3.6 .4 2.9 .2 .1 .0 11 81 6 2 0 5.6 1.1 4.2 .2 .1 .0 19 75 4 2 0 3.1 .5 2.4 .1 .1 .0 15 78 4 2 0 4.1 .9 2.7 .3 .1 .0 22 67 7 3 1 3.6 .4 2.8 .3 .1 .0 11 77 9 2 1 4.2 .8 3.0 .2 .1 .0 20 72 5 3 0 MEAN S.D. N 4.0 .8 3.0 .2 .1 .0 19 74 5 2 0 .95 .47 .69 .12 .03 .00 8.5 8.8 2.8 .6 .4 10 10 10 10 10 10 10 10 10 10 10 Group: 2 Dose Level : 3 Dosage Unit: ppm MeFOS C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 3.6 .4 2.9 .3 .1 .0 10 80 7 2 0 3.1 .6 2.1 .2 .1 .0 19 70 8 3 0 4.0 .7 2.9 .2 .1 .0 19 72 6 3 0 4.0 1.0 2.7 .3 .1 .0 24 67 7 2 0 6.7 .5 5.8 .3 .1 .0 8 86 4 1 0 6.6 .8 5.4 .3 .1 .0 12 82 5 2 0 5.0 .7 4.0 .3 .1 .0 13 80 5 1 0 4.3 .8 3.3 .2 .1 .0 18 75 5 1 0 5.3 .6 4.4 .2 .1 .0 11 82 5 2 0 MEAN S.D. N 4.7 .7 3.7 .3 .1 .0 15 77 6 2 0 1.27 .18 1.27 .05 .00 .00 5.3 6.4 1.3 .8 .0 9 9999999999 004793 246 i ANIMAL NUMBER WBC XIO'/^L Appendix 5 Individual Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE , T-6314) IN RATS N-SEG LYMPH XIO'/^L XIO'/k L MONO EOS IN X10J/^L X105/*iL BASO N-SEG% XlOV^iL LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO Group: 3 Dose Level : 30 Dosage Unit: ppm MeFOS C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 6.9 .6 6.1 .1 .1 .0 8 89 2 1 0 5.1 .8 3.9 .3 .1 .0 15 77 6 1 0 5.1 .8 3.8 .4 .1 .0 16 74 8 2 0 4.9 .9 3.5 .3 .1 .0 19 72 6 2 0 4.5 .5 3.8 .2 .1 .0 10 83 4 1 0 6.6 1.9 4.2 .3 .1 .0 29 65 5 1 0 5.4 .9 4.1 .4 .1 .0 16 75 7 1 0 7.8 .6 6.7 .4 .1 .1 7 86 5 2 1 6.0 1.8 3.9 .2 .1 .0 29 65 4 1 0 4.8 .8 3.6 .3 .1 .0 17 75 6 1 0 MEAN S.D. N 5.7 1.0 4.4 .3 .1 .0 17 76 5 1 0 1.08 .49 1.10 .10 .00 .03 7.6 8.0 1.,7 .5 10 10 10 10 10 10 10 10 10 10 10 Group: 4 Dose Level : 100 Dosage Unit: ppm MeFOS C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 2.9 .4 2.3 .1 .0 .0 14 81 4 1 0 3.6 .6 2.8 .2 .1 .0 17 76 4 2 0 9.7 1.0 8.4 .2 .1 .0 10 86 2 1 0 6.4 .6 5.5 .3 .1 .0 9 85 4 1 1 3.9 .3 3.4 .0 .1 .0 8 89 0 1 0 4.0 1.1 2.6 .2 .1 .0 28 65 5 2 0 4.7 .4 4.1 .2 .0 .0 7 88 4 1 0 3.8 .9 2.6 .3 .1 .0 24 67 7 3 0 3.0 .4 2.5 .1 .1 .0 13 82 3 2 0 4.8 .5 4.0 .2 .1 .0 11 84 4 2 0 MEAN S.D. N 4.7 .6 3.8 .2 .1 .0 14 80 4 2 0 2.03 .28 1.89 .09 .04 .00 7.0 8.4 1. 8 .7 10 10 10 10 10 10 10 10 10 10 10 004794 247 Appendix 5 Individual Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 1 C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 Dose Level: 0 __ -- ----- --- -- -- Dose Level : 3 _ ---- --- --- -- Dosage Unit: ppm MeFOS _ _ __ ------------ _ ----- --- Dosage Unit: ppm MeFOS _ ---------- --_ ----- Covance 6329-225 3M T-6314.1 004795 248 i f I Appendix 5 Individual Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ANISO POLY POIK HYPO TOXNEUT Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 Dose Level: 30 Dose Level: 100 Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 i 'i 004796 249 II ' ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Males Week 5 13-WEEK 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 TRIG MG/DL Covance 6329-225 3M T-6314.1 Group: 1 Dose Level : 0 Dosage Unit: ppm MeFOS C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 101 9 .7 7.3 4.8 2.5 .2 60 47 98 11 .7 7.3 4.8 2.5 .2 57 31 109 14 .6 7.0 4.5 2.5 .2 76 33 107 12 .7 6.5 4.4 2.1 .2 50 40 96 11 .6 7.0 4.8 2.2 .2 56 42 100 9 .6 7.4 5.0 2.4 .2 83 94 107 9 .5 6.3 4.3 2.0 .2 32 37 110 13 .7 7.1 4.9 2.2 .2 76 33 94 12 .6 6.5 4.7 1.8 .2 54 49 105 9 .7 6.7 4.8 1.9 .2 47 46 MEAN S.D. N 103 11 .6 6.9 4.7 2.2 .2 59 45 5.7 1.9 .07 .39 .23 .26 .00 15.4 18.3 10 10 10 10 10 10 10 10 10 Group: 2 Dose Level : 3 Dosage Uni t : ppm MeFOS C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 116 10 .7 7.1 5.1 2.0 .2 50 44 109 11 .6 6.5 4.5 2.0 .2 51 51 117 10 .6 7.0 4.8 2.2 .2 54 30 107 14 .7 6.6 4.5 2.1 .2 88 44 148 9 .7 7.1 4.7 2.4 .2 62 50 108 12 .6 7.0 4.7 2.3 .2 50 53 104 12 .6 6.9 4.7 2.2 .2 59 75 103 10 .6 6.9 4.9 2.0 .2 45 92 103 10 .6 6.6 4.6 2.0 .2 60 69 127 11 .7 7.1 4.9 2.2 .2 63 38 MEAN 114 11 .6 6.9 4.7 2.1 .2 58 55 S.D. 14.1 1.4 .05 .23 .19 .14 .00 12.1 18.8 N 10 10 10 10 10 10 10 10 10 >1 250 I ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Males Week 5 13-WEEK 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 TRIG MG/DL Covance 6329-225 3M T-6314.1 Group : 3 Dose Level : 30 Dosage Unit: ppm MeFOS C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 93 12 .6 6.5 4.8 1.7 .2 51 41 114 10 .6 7.1 4.8 2.3 .2 48 63 129 11 .6 6.5 4.6 1.9 .2 46 26 91 10 .6 6.8 4.7 2.1 .2 67 40 111 10 .6 6.5 4.5 2.0 .2 42 30 104 15 .6 6.9 4.8 2.1 .2 58 33 116 14 .6 6.4 4.6 1.8 .1 73 39 124 11 .6 6.6 4.9 1.7 .2 57 39 84 11 .6 6.7 4.6 2.1 .2 54 49 90 11 .5 6.5 4.5 2.0 .2 40 36 MEAN S.D. N 106 12 .6 6.6 4.7 2.0 .2 54 40 15.6 1..7 .03 .22 .14 .19 .03 10. 6 10 10 10 10 10 10 10 10 10 10 Group: 4 Dose Level : 100 Dosage Uni t : ppm MeFOS C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 152 17 90 11 97 12 102 13 94 12 110 13 99 13 111 12 105 13 98 13 .7 6.4 4.4 2.0 .6 6.6 4.7 1.9 .7 6.8 4.8 2.0 .6 6.4 4.8 1.6 .6 7.0 4.9 2.1 .5 6.3 4.4 1.9 .6 6.9 4.8 2.1 .6 7.1 4.8 2.3 .5 6.5 4.5 2.0 .6 7.0 5.0 2.0 .2 26 12 .2 25 27 .2 60 45 .2 64 29 .2 41 25 .2 34 16 .2 55 24 .2 54 35 .2 35 17 .2 51 18 MEAN S.D. N 106 13 .6 6.7 4.7 2.0 .2 44 25 17.5 1. 6 .07 .29 .21 .18 .00 14. 1 9 10 10 10 10 10 10 10 10 10 004798 251 t i 4 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Males Week 5 13-WEEK 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 Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 MEAN S.D. N Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 MEAN S.D. N Dose Level:: 0 98 34 86 35 71 25 99 31 97 34 143 35 114 26 100 33 111 33 109 30 103 18.9 10 32 3.6 10 Dose Level:; 3 92 33 115 35 95 39 86 26 79 29 108 41 74 35 123 32 83 30 103 30 96 16.1 10 33 4.6 10 Dosage Unit: ppm MeFOS 1 11.7 10.2 0 11.3 9.9 1 11.0 9.0 0 10.4 10.5 0 10.4 8.5 0 11.6 9.6 1 10.5 8.9 0 11.0 9.7 0 10.7 9.3 0 10.8 9.3 0 .5 10 10.9 .47 10 9.5 .61 10 Dosage Uni t : ppm MeFOS 0 11.1 11.1 1 10.6 9.0 0 10.7 10.3 1 11.0 10.3 0 10.7 9.0 0 10.9 9.5 0 11.1 9.6 0 10.9 10.5 0 10.7 9.7 1 10.6 9.1 0 .5 10 10.8 .19 10 9.8 .71 10 149 149 145 146 148 146 147 147 147 146 147 1 .3 10 6.6 6.8 6.1 5.7 6.1 6.8 6.4 6.1 6.0 5.8 6.2 .39 10 150 145 147 147 145 147 146 149 147 148 147 1 .6 10 7.0 6.0 7.0 6.1 5.9 6.1 5.9 6.2 5.9 6.3 6.2 .42 10 107 107 102 103 107 101 106 104 103 106 105 2 10 108 102 105 106 105 104 104 105 103 105 105 1 10 Covance 6329-225 3M T-6314.1 004799 252 i ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Males Meek 5 13-WEEK 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 Group: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 MEAN S.D. N Dose Level: 30 131 33 109 36 95 32 113 32 76 27 82 31 90 36 88 34 125 38 105 26 101 18.3 10 32 3.8 10 Dose Level: 100 86 36 113 41 93 35 122 41 103 41 91 41 94 50 88 40 90 41 86 34 97 12.2 10 40 4.5 10 Dosage Unit: ppm MeFOS 0 10.5 9.0 0 10.8 9.0 2 10.1 8.7 0 10.9 9.9 0 10.6 9.0 0 10.3 7.7 0 10.1 8.2 1 10.6 10.4 1 10.4 8.9 0 10.9 9.5 0 .7 10 10.5 .30 10 9.0 .78 10 Dosage Unit: ppm MeFOS 0 10.2 11.4 0 10.2 8.9 0 10.9 9.6 1 10.8 9.0 0 10.6 9.3 0 10.0 7.9 0 11.2 9.2 0 10.9 9.1 0 10.0 7.8 0 10.7 8.3 0 .3 10 10.6 .42 10 9.0 1.02 10 147 150 147 147 146 147 147 148 149 147 148 1.2 10 6.6 6.5 6.3 6.6 5.4 5.2 5.6 6.0 6.3 6.5 6.1 .52 10 146 148 148 149 148 143 150 146 142 146 147 2.5 10 5.8 6.0 6.5 6.5 6.5 5.1 6.1 6.5 6.1 5.7 6.1 .46 10 106 107 105 105 104 108 107 107 105 106 106 1 10 103 107 106 109 104 104 108 103 102 102 105 2 10 Covance 6329-225 3M T-6314.1 004800 253 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Females Week 5 13-WEEK 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 TRIG MG/DL Covance 6329-225 3M T-6314.1 Group: 1 Dose Level : 0 Dosage Unit: ppm MeFOS C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 101 13 .7 8.1 5.6 2.5 .2 80 34 119 11 .7 7.3 5.5 1.8 .2 76 26 117 13 .7 7.3 4.9 2.4 .2 67 30 111 13 .7 7.7 5.4 2.3 .3 58 30 110 14 .7 7.4 5.5 1.9 .3 93 39 92 12 .7 7.3 5.3 2.0 .2 64 16 105 11 .7 7.2 5.3 1.9 .2 61 35 99 13 .7 7.3 5.2 2.1 .2 58 20 120 12 .7 7.0 5.1 1.9 .2 55 26 111 10 .6 7.6 5.4 2.2 .3 66 42 MEAN S.D. N 108 12 .7 7.4 5.3 2.1 .2 68 30 9.2 1.,2 .03 .31 .21 .24 .05 11.,9 8..1 10 10 10 10 10 10 10 10 10 Group: 2 Dose Level : 3 Dosage Uni t : ppm MeFOS C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 MEAN S.D. N 99 9 .6 7.3 5.4 1.9 99 11 .7 7.6 5.8 1.8 107 10 .7 7.0 4.9 2.1 95 9 .6 6.9 5.0 1.9 115 14 .7 7.4 5.0 2.4 116 14 .7 6.9 4.8 2.1 103 10 .7 7.5 5.3 2.2 116 11 .7 8.5 6.0 2.5 105 14 .7 7.2 5.2 2.0 121 13 .7 7.2 5.4 1.8 .2 53 20 .2 54 19 .2 87 40 .2 70 43 .2 81 25 .2 68 24 .2 54 19 .2 75 36 .2 78 22 .2 69 28 108 12 .7 7.4 5.3 2.1 .2 69 28 8.9 2. 1 .04 .47 .39 .24 .00 12. 0 8. 9 10 10 10 10 10 10 10 10 10 004801 254 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Females Week 5 13-WEEK 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 TRIG MG/DL Covance 6329-225 3M T-6314.1 Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 MEAN S.D. N Group: 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 MEAN S.D. N Dose Level : 30 102 10 116 13 113 12 95 12 111 13 94 12 105 10 123 11 117 13 99 15 108 10.0 10 12 1.5 10 Dose Level : 100 89 12 98 15 75 13 96 12 105 11 90 15 84 14 117 15 89 15 104 13 95 12.0 10 14 1.5 10 Dosage Unit: ppm MeFOS .7 7.6 5.5 .7 7.1 5.3 .7 7.9 5.9 .6 7.1 5.3 .7 7.7 5.4 .7 6.9 4.9 .7 7.1 5.3 .7 7.0 4.9 .7 7.0 5.3 .7 7.2 5.4 .7 7.3 5.3 .03 .34 .29 10 10 10 Dosage Unit: ppm MeFOS .6 7.1 5.4 .6 7.5 5.5 .6 7.5 5.4 .6 7.5 5.4 .6 6.8 5.0 .6 6.6 4.7 .8 7.1 5.4 .7 8.0 5.7 .6 7.0 5.4 .7 7.3 5.2 .6 7.2 5.3 .07 .41 .28 10 10 10 2.1 1.8 2.0 1.8 2.3 2.0 1.8 2.1 1.7 1.8 1.9 .19 10 1.7 2.0 2.1 2.1 1.8 1.9 1.7 2.3 1.6 2.1 1.9 .23 10 .2 62 28 .2 52 30 .2 75 25 .2 73 37 .2 69 21 .2 53 25 .2 76 43 .2 53 26 .2 58 28 .1 71 21 .2 64 28 .03 9..7 6.9 10 10 10 .2 46 .2 100 .2 43 .2 86 .2 50 .2 38 .2 48 .2 37 .2 39 .2 45 24 48 17 34 26 24 20 21 17 26 .2 53 26 .00 21. 7 9.3 10 10 10 Q8frOQ 255 i ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Females Week 5 13-WEEK 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 Group: 1 C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C9S989 C95990 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 MEAN S.D. N Dose Level : 0 71 31 91 24 85 23 120 34 91 25 99 25 99 36 101 24 111 28 119 33 99 15.3 10 28 4.8 10 Dose Level :: 3 91 30 99 25 81 22 95 25 105 36 83 23 94 30 97 21 89 23 100 31 93 7.5 10 27 4.9 10 Dosage Uni t : ppm MeFOS 1 12.0 0 10.8 1 10.6 0 10.7 0 11.2 1 10.4 0 10.3 0 10.5 1 10.5 0 11.2 8.5 8.0 7.0 7.8 8.1 8.1 7.1 8.0 7.4 9.2 0 .5 10 10.8 .52 10 7.9 .65 10 Dosage Unit: ppm MeFOS 0 10.4 0 10.9 1 10.9 0 10.6 0 11.3 1 10.3 0 10.8 0 11.3 2 10.2 0 10.4 7.9 8.7 8.2 8.8 9.8 7.9 8.3 8.3 7.3 7.1 0 .7 10 10.7 .40 10 8.2 .77 10 147 148 148 147 144 146 145 146 146 146 146 1.3 10 6.0 6.5 6.2 6.0 6.3 5.8 5.5 5.9 5.7 6.3 6.0 .31 10 144 149 146 145 149 147 147 147 146 147 147 1.6 10 5.4 5.9 6.4 5.5 6.1 5.5 5.8 6.5 5.5 5.7 5.8 .39 10 105 107 105 106 103 104 105 104 104 104 105 1 10 105 104 106 105 105 107 105 102 106 106 105 1 10 Covance 6329-225 3M T-6314.1 C0800 256 I ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Females Week 5 13-WEEK 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 Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 MEAN S.D. N Group: 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 MEAN S.D. N Dose Level:: 30 91 30 99 29 86 25 118 25 83 28 80 21 97 31 73 31 112 26 93 32 93 14.0 10 28 3. 5 10 Dose Level : 100 96 26 119 23 106 31 82 34 67 28 88 36 113 39 86 26 91 34 80 22 93 16.0 10 30 5. 8- 10 Dosage Uni t : ppm MeFOS 0 11.4 1 10.6 3 10.7 0 10.9 0 11.0 2 10.5 0 11.1 1 10.7 1 10.0 2 10.8 9.4 8.0 6.2 8.8 6.9 8.3 8.6 7.2 6.4 7.4 1 1.1 10 10.8 .38 10 7.7 1.07 10 Dosage Unit: ppm MeFOS 1 10.4 0 11.2 1 10.7 0 11.2 1 10.7 0 10.6 0 10.4 2 10.3 2 10.5 1 10.5 8.2 8.4 8.2 9.6 8.6 8.9 9.2 6.8 8.5 6.1 1 .8 10 10.6 .32 10 8.2 1.06 10 150 146 145 144 145 146 146 145 145 149 146 1.9 10 7.2 6.0 5.1 6.4 5.8 5.6 6.4 5.7 5.4 6.0 6.0 .60 10 149 143 149 146 148 146 147 147 150 147 147 2.0 10 5.6 6.3 5.7 6.7 5.9 5.9 5.8 5.0 5.8 5.0 5.8 .52 10 107 102 103 103 104 107 104 104 103 107 104 1 10 107 101 108 103 107 107 104 109 109 106 106 2 10 Covance 6329-225 3M T-6314.1 004804 257 4 i Appendix 5 Individual Clinical Chemistry Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group: 1 C95911 C95912 C95913 C95914 C95915 MEAN S.D. N Group: 2 C95931 C95932 C95933 C95934 C95935 MEAN S.D. N Group: 3 C95951 C95952 C95953 C95954 C95955 MEAN S.D. N Dose Level 11 9 13 10 18 12 3.6 5 Dose Level 12 15 13 11 16 13 2.1 5 Dose Level 30 14 7 2 8 9 8 4.3 5 Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Dosage unit: ppm MeFOS Covance 6329-225 3M T-6314.1 S 0 8 fr0 0 258 i Appendix 5 Individual Clinical Chemistry Data Males Meek 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group: 4 C95971 C95972 C95973 C95974 C95975 MEAN S.D. N Dose Level 100 7 8 9 12 9 9 1.9 5 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 i &04806 259 'i Appendix 5 Individual Clinical Chemistry Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group: 1 C95991 C95992 C95993 C95994 C95995 MEAN S.D. N Group: 2 C96011 C96012 C96013 C96014 C96015 MEAN S.D. N Group: 3 C96031 C96032 C96033 C96034 C96035 MEAN S.D. N Dose Level: 0 6 9 3 7 9 7 2.5 5 Dose Level : 3 6 3 9 3 2 5 2.9 5 Dose Level : 30 7 6 5 5 13 7 3.3 5 Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 004807 260 i Appendix 5 Individual Clinical Chemistry Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group: 4 C96051 C96052 C96053 C96054 C96055 MEAN S.D. N Dose Level: 100 8 9 11 10 15 11 2.7 5 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 1 8 0 8 fr0 0 261 I f I ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Males Meek 14 13-WEEK 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 TRIG MG/DL Covance 6329-225 3M T-6314.1 Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 MEAN S.D. N Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 MEAN S.D. N Dose Level : 0 125 12 123 13 107 14 120 17 106 11 120 11 106 14 115 13 126 10 125 11 117 8.2 10 13 2,.1 10 Dose Level : 3 115 10 129 15 121 15 126 10 118 13 125 14 115 12 105 10 109 10 126 13 119 7.9 10 12 2. 1 10 Dosage Unit: ppm MeFOS .8 7.5 4.8 .8 7.5 4.6 .8 7.3 4.7 .8 6.8 4.5 .7 6.8 4.6 .7 7.6 5.1 .8 6.7 4.4 .8 7.3 4.9 .7 7.5 5.1 .7 7.2 4.7 .8 7.2 4.7 .05 .34 .24 10 10 10 Dosage Uni t : ppm MeFOS .7 6.9 4.8 .8 6.7 4.6 .7 6.5 4.4 .7 7.1 4.6 .8 7.1 4.7 .8 7.3 4.9 .8 7.1 5.0 .7 6.8 4.5 .7 7.6 4.9 .7 6.6 4.5 .7 7.0 4.7 .05 .34 .20 10 10 10 2.7 2.9 2.6 2.3 2.2 2.5 2.3 2.4 2.4 2.5 2.5 .21 10 2.1 2.1 2.1 2.5 2.4 2.4 2.1 2.3 2.7 2.1 2.3 .21 10 .2 54 76 .1 71 34 .2 69 61 .2 80 61 .1 53 64 .2 100 111 .1 54 53 .1 82 50 .1 64 43 .2 60 39 .2 69 59 .05 15. 2 22 10 10 10 .2 37 44 .1 44 83 .1 87 42 .1 60 41 .2 41 43 .2 56 84 .1 38 75 .1 61 89 .1 69 28 .1 79 36 .1 57 56 .05 17. 4 23 10 10 10 004809 262 ANIMAL NUMBER Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data Males Week 14 13-WEEK 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 TRIG MG/DL Covance 6329-225 3M T-6314.1 Dose Level : 30 Dosage Unit: ppm MeFOS 122 14 .7 6.6 4.8 1.8 .1 39 31 119 12 .8 7.6 5.1 2.5 .2 45 33 124 11 .7 6.7 4.7 2.0 .2 33 58 100 12 .7 6.7 4.6 2.1 .2 59 38 115 16 .8 6.6 4.5 2.1 .1 71 35 108 12 .9 7.0 4.7 2.3 .2 57 47 94 15 .7 5.4 3.8 1.6 .2 36 25 119 15 .7 6.7 4.8 1.9 .1 31 23 117 13 .8 7.0 4.5 2.5 .1 72 39 114 17 .8 7.2 4.9 2.3 .2 50 32 113 14 .8 6.8 4.6 2.1 .2 49 36 9.7 2. 0 .07 .57 .35 .30 .05 15.1 10.3 10 10 10 10 10 10 10 10 10 Dose Level : 100 Dosage Unit: ppm MeFOS 131 16 .7 7.3 5.1 2.2 .2 13 15 121 13 .7 6.5 4.9 1.6 .3 11 12 153 16 .8 7.5 5.6 1.9 .2 39 27 140 16 .8 7.4 5.6 1.8 .2 37 21 120 14 .7 7.3 5.3 2.0 .2 25 18 123 15 .7 7.5 5.3 2.2 .2 46 21 120 13 .8 7.7 5.2 2.5 .2 31 16 123 17 .7 6.8 4.7 2.1 .2 15 9 116 14 .7 6.7 4.9 1.8 .1 19 19 131 15 .7 7.1 5.1 2.0 .2 20 14 128 15 .7 7.2 5.2 2.0 .2 26 17 11.3 1. 4 .05 .39 .29 .26 .05 12.1 5.2 10 10 10 10 10 10 10 10 10 004810 263 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Males Week 14 13-WEEK 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 Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 MEAN S.D. N Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 MEAN S.D. N Dose Level: 0 101 44 95 38 87 35 107 42 110 39 87 38 109 47 59 29 68 35 70 36 89 18.4 10 38 5.1 10 Dose Level: 3 86 49 80 44 83 36 95 43 94 50 69 39 91 44 100 30 75 34 92 39 86 9.7 10 41 6.4 10 Dosage Unit: ppm MeFOS 3 11.3 3 10.6 1 10.8 0 10.3 3 9.9 3 11.3 3 10.2 2 11.2 0 11.0 1 10.6 7.8 6.0 7.6 7.0 6.2 6.2 6.2 6.2 6.4 6.2 2 1. 3 10 10.7 .49 10 6.6 .65 10 Dosage Unit: ppm MeFOS 2 10.3 2 10.8 2 10.3 3 10.2 3 10.6 2 10.9 3 10.8 3 10.3 3 10.7 1 10.7 6.7 6.7 6.7 6.2 6.1 6.9 6.5 6.1 6.4 6.7 2 ,7 10 10.6 .26 10 6.5 .29 10 154 148 152 149 147 146 148 150 151 151 150 2. 5 10 6.2 6.4 6.5 6.1 6.1 5.7 5.9 5.9 6.3 5.5 6.1 .31 10 150 151 146 148 152 148 150 147 152 152 150 2. 2 10 5.9 6.2 6.1 6.1 6.3 6.1 6.4 5.5 5.8 6.4 6.1 .28 10 113 107 110 109 106 102 107 109 111 113 109 3 10 111 110 105 106 111 105 110 105 112 112 109 3 10 Covance 6329-225 3H T-6314.1 &04811 264 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Males Week 14 13-WEEK 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 Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 MEAN S.D. N Dose Level;: 30 96 44 111 45 82 31 74 38 75 36 84 45 126 49 94 34 88 28 78 34 91 16.7 10 38 7.0 10 Dose Level: 100 73 46 83 48 63 33 100 64 99 65 95 57 108 70 86 36 99 70 102 108 91 14.3 10 60 21.6 10 Dosage Unit: ppm MeFOS 3 10.3 1 10.3 3 10.0 3 10.6 1 10.1 3 10.6 0 9.2 2 10.3 3 10.4 4 10.4 6.3 6.2 6.8 7.5 6.4 7.2 5.5 6.8 6.0 6.6 2 1.3 10 10.2 .40 10 6.5 .58 10 Dosage Unit: ppm MeFOS 3 10.6 2 10.0 2 10.9 1 10.6 3 10.6 2 10.6 3 10.5 2 10.0 1 10.1 2 10.5 6.6 6.8 7.1 7.3 7.3 6.7 7.3 6.2 6.4 7.0 2 .7 10 10.4 .30 10 6.9 .39 10 150 151 149 150 145 150 145 150 151 150 149 2. 2 10 6.5 6.4 6.1 6.5 5.4 6.3 5.8 6.1 6.2 6.5 6.2 .36 10 152 150 154 152 153 147 147 147 150 151 150 2. 6 10 6.9 6.5 6.4 7.0 6.7 5.6 6.6 6.3 5.6 6.5 6.4 .48 10 112 111 109 111 104 105 104 108 110 110 108 3 10 112 108 112 112 109 102 103 108 111 112 109 3 10 Covance 6329-225 3M T-6314.1 Z T 8^00 265 ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK 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 TRIG MG/DL Covance 6329-225 3M T-6314.1 Group: 1 C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 MEAN S.D. N Dose Level: 0 123 14 137 11 125 15 133 9 115 11 114 15 107 12 120 13 114 11 104 13 119 10.6 10 12 2. 0 10 Dose Level: 3 120 10 123 11 124 13 113 17 138 13 125 11 111 14 116 14 123 12 121 8.0 9 13 2. 1 9 Dosage Unit: ppm MeFOS .9 8.3 5.9 .9 8.5 5.9 .9 8.1 6.2 .8 7.5 5.7 .8 7.9 6.1 .9 8.0 5.7 .9 8.7 6.4 .7 7.2 5.4 .8 7.5 5.6 .9 7.4 5.0 .8 7.9 5.8 .07 .50 .41 10 10 10 Dosage Unit: ppm MeFOS .7 7.6 5.6 .8 7.6 5.9 .8 7.1 5.0 .7 7.0 5.0 .9 8.6 6.0 .7 8.3 6.1 .8 7.3 5.2 .8 7.9 5.7 .8 7.7 5.7 .8 7.7 5.6 .07 .53 .42 999 2.4 2.6 1.9 1.8 1.8 2.3 2.3 1.8 1.9 2.4 2.1 .31 10 2.0 1.7 2.1 2.0 2.6 2.2 2.1 2.2 2.0 2.1 .24 9 .2 69 .2 68 .2 101 .2 60 .2 66 .2 68 .3 90 .2 70 .2 71 .2 66 55 40 37 31 35 28 86 41 35 39 .2 73 43 .03 12.6 16.8 10 10 10 .1 52 19 .2 57 24 .2 78 32 .1 69 34 .1 70 34 .2 67 92 .2 73 28 .2 76 45 .1 80 34 .2 69 38 .05 9.4 21.5 999 ^8^00 266 ANIMAL NUMBER Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 MEAN S.D. N Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH 1l-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 TRIG MG/DL Covance 6329-225 3M T-6314.1 Dose Level : 30 Dosage Unit: ppm MeFOS 109 13 .8 7.7 5.6 2.1 .2 57 35 111 16 .9 7.8 5.9 1.9 .2 58 30 97 13 .8 8.3 6.1 2.2 .2 74 29 105 12 .7 7.8 5.6 2.2 .2 66 36 116 13 .9 8.8 6.0 2.8 .2 75 26 122 12 .7 7.6 5.5 2.1 .2 59 32 103 13 .8 7.6 5.7 1.9 .2 78 69 113 17 .8 7.7 5.7 2.0 .2 78 . 26 113 16 .9 8.2 5.7 2.5 .2 74 44 111 13 .8 8.5 6.2 2.3 .1 86 37 110 14 .8 8.0 5.8 2.2 .2 70 36 7.0 1. 8 .07 .42 .24 .28 .03 9. 9 12.7 10 10 10 10 10 10 10 10 10 Dose Level : 100 Dosage Unit: ppm MeFOS 100 15 .8 9.0 6.6 2.4 .2 84 32 116 14 .9 8.6 6.4 2.2 .2 65 29 125 15 .8 7.6 5.6 2.0 .2 45 26 116 18 .9 7.8 5.6 2.2 .2 56 23 109 17 .8 8.1 6.2 1.9 .2 50 18 120 18 .9 8.6 6.1 2.5 .2 30 21 111 18 .8 7.7 5.9 1.8 .2 35 25 104 20 .7 7.9 5.7 2.2 .2 34 22 95 19 .8 8.7 6.4 2.3 .2 42 22 109 14 .8 7.8 5.9 1.9 .2 71 28 110 17 .8 8.2 6.0 2.1 .2 51 25 9.2 2.,1 .06 .50 .36 .23 .00 17,,7 4.2 10 10 10 10 10 10 10 10 10 004814 267 I ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK 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 Group: 1 C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 MEAN S.D. N Dose Level :! 0 74 27 92 34 79 31 77 31 79 35 101 35 88 48 78 37 75 30 99 33 84 10.1 10 34 5.7 10 Dose Level : 3 91 36 100 31 190 96 89 30 101 44 81 30 101 42 94 35 114 40 107 32.6 9 43 20.7 9 Dosage Unit: ppm MeFOS 4 11.0 3 10.9 2 11.0 3 10.7 1 11.0 3 11.1 1 11.7 3 11.2 1 10.9 4 10.5 4.2 4.2 4.6 4.4 5.0 5.6 5.4 5.0 5.5 4.4 2 1.2 10 11.0 .32 10 4.8 .54 10 Dosage Unit: ppm MeFOS 1 10.7 1 10.6 3 10.6 3 10.4 3 11.7 4 10.7 3 10.5 1 11.1 4 11.1 5.3 4.3 4.3 5.0 7.3 4.3 5.0 5.3 5.4 3 10.8 1.2 .41 99 5.1 .93 9 152 153 149 151 149 148 152 150 149 147 150 1. 9 10 6.1 5.7 5.4 5.3 5.8 5.5 6.2 5.6 5.6 5.9 5.7 .29 10 150 149 150 147 159 147 149 150 151 150 3. 6 9 6.0 5.8 5.9 5.8 7.7 5.1 6.2 6.1 6.4 6.1 .70 9 113 113 110 114 110 107 112 113 111 106 111 2.7 10 115 108 111 109 114 105 110 114 113 111 3.3 9 Covance 6329-225 3M T-6314.1 268 I ANIMAL NUMBER Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESUUFONAMIDO 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 Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 MEAN S.D. N Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C 96050 C96056 C96060 MEAN S.D. N Dose Level : 30 84 30 81 29 88 30 65 22 87 35 76 29 106 34 78 33 130 34 485 364 128 126.7 10 64 105.5 10 Dose Level :; 100 95 30 75 31 70 33 78 41 79 32 79 31 91 48 66 31 90 38 82 41 80 9.3 10 36 6.1 10 Dosage Unit: ppm MeFOS 6 11.2 4 11.2 1 11.0 1 11.0 2 11.6 2 10.6 4 10.9 2 10.9 3 10.9 5 11.1 6.0 6.2 4.3 5.6 6.5 4.7 5.2 6.5 5.3 5.9 3 1.7 10 11.0 .26 10 5.6 .74 10 Dosage Unit: ppm MeFOS 3 11.5 3 11.3 5 10.6 3 11.0 1 10.9 2 10.7 3 10.9 2 10.8 3 10.8 3 10.9 5.3 5.6 5.9 5.8 6.8 4.8 6.3 5.4 3.6 4.7 3 1.0 10 10.9 .27 10 5.4 .90 10 153 156 147 150 152 148 149 151 149 151 151 2. 6 10 6.9 6.7 5.9 5.6 6.2 5.3 6.4 6.3 5.8 6.5 6.2 .50 10 150 154 147 151 149 151 155 149 147 152 150 2. 7 10 6.0 6.0 5.5 6.2 5.8 5.1 6.5 5.4 5.4 5.5 5.7 .43 10 112 113 105 111 109 109 106 110 107 111 109 2 10 110 111 104 110 108 110 112 110 105 114 109 3 10 Covance 6329-225 3M T-6314.1 004816 269 I Appendix 5 Individual Clinical Chemistry Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95916 C95917 C95918 C95919 C95920 MEAN S.D. N Dose Level: 0 4 11 11 10 11 12 8 10 10 8 11 11 13 8 7 10 2.3 15 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 270 Appendix 5 Individual Clinical Chemistry Data Males Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C9592B C95929 C95930 C95936 C95937 C95938 C95939 C95940 MEAN S.D. N Dose Level 10 10 7 11 10 11 12 12 12 12 10 4 9 8 4 9 2.7 15 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 004818 I 271 Appendix 5 Individual Clinical Chemistry Data Males Meek 14 13-WEEK d i e t a r y t o x i c i t y s t u d y w i t h n -m e t h y l p e r f l u o r o o c t a n e s u l f o n a m i d o ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group : 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95956 C95957 C9595B C95959 C95960 MEAN S.D. N Dose Level 10 9 8 10 7 9 9 12 6 12 5 11 10 9 9 9 2.0 15 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 i. 4 272 i Appendix 5 Individual Clinical Chemistry Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 C95976 C95977 C95978 C95979 C95980 MEAN S.D. N Dose Level: 100 17 11 12 11 5 12 38 13 19 22 22 5 12 15 16 15 8.1 15 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 t 4 004820 273 4 Ii Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group : 1 C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95996 C95997 C95998 C95999 C96000 MEAN S.D. N Dose Level 10 11 5 5 9 4 4 5 7 8 3 8 10 7 7 7 2.5 15 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 4 004821 274 I Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 C96017 C96018 C96019 C96020 MEAN S.D. N Dose Level : 3 6 4 10 5 8 3 4 5 10 10 4 8 11 10 7 2.9 14 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 004822 275 Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group : 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96036 C96037 C96038 C96039 C96040 MEAN S.D. N Dose Level 4 11 14 5 8 11 7 9 11 12 9 10 10 10 5 9 2.8 15 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 f 004823 I 276 Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL {N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER PCOAO IU/G Group : 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96057 C96058 C96059 C96060 MEAN S.D. N Dose Le\ 27 22 16 20 17 12 36 11 20 23 19 22 21 19 8 20 6 15 Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 004824 277 I Appendix 5 Individual Clinical Urinalysis Data Males Week 14 13-WEEK 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 C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 MEAN S.D. N Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 MEAN S.D. N Dose Level: 0 18.0 7.6 12.5 6.4 4.0 7.7 .8 12.0 24.7 5.0 1.018 1.034 1.026 1.044 1.039 1.030 1.074 1.025 1.013 1.052 9.9 7.15 10 1.036 .0179 10 Dose Level: 3 10.2 6.4 10.6 19.6 2.6 4.7 17.5 8.0 15.3 11.2 1.023 1.026 1.030 1.016 1.040 1.043 1.016 1.030 1.020 1.021 10.6 5.52 10 1.026 .0093 10 Dosage 7.0 7.0 7.0 6.5 7.0 7.0 6.5 7.0 7.5 6.5 6.9 .32 10 Dosage 7.5 7.0 7.0 7.0 6.5 6.5 7.0 6.5 7.5 6.5 6.9 .39 10 ppm MeFOS ppm MeFOS Covance 6329-225 3M T-6314.1 004825 278 004826 Appendix 5 Individual Clinical Urinalysis Data Males Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U VOL ML SP GR U PH Group : 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group : 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 MEAN S.D. N Dose Level:: 30 9.1 21.1 17.1 3.5 10.4 13.6 47.5 a 6.0 1.3 8.0 1.022 1.013 1.021 1.037 1.024 1.014 1.002 1.037 1.060 1.030 13.8 13.29 10 1.026 .0162 10 Dose Level:: 100 38.5 6.3 14.4 5.6 10.0 19.0 48.2 a 45.2 a 14.5 8.3 1.010 1.042 1.024 1.047 1.031 1.019 1.007 1.004 1.023 1.037 21.0 16.52 10 1.024 .0148 10 Dossaaggee Unit: ppm MeFOS 7.5 6.5 7.0 7.0 7.0 7.0 6.0 6.5 6.5 7.0 6.8 .42 10 Dossaaggee Unit: ppm MeFOS 7.0 6.5 6.5 6.5 6.5 7.0 6.5 7.0 6.5 6.5 6.6 .24 10 a Sample was overflowing at the time of collection. 279 Covance 6329-225 3M T-6314.1 Appendix 5 Individual Clinical Urinalysis Data Males Week 14 13-WEEK 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 C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 Dose Level: 0 30 30 30 300 30 30 100 30 30 30 - - - - - - Dose Level : 3 30 30 30 - 30 30 - 30 30 - 30 30 - 10 - Dosage Unit: ppm MeFOS - + + +++ + - +++ + + + - - - - - ++ - Dosage Unit: ppm MeFOS -- +-- -- ++ ++ ++ -- -- - - - - - - - - - - - - - - Covance 6329-225 3M T-6314.1 004827 -380- Appendix 5 Individual Clinical Urinalysis Data Males Week 14 13-WEEK 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: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95950 C95960 Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 Dose Level: 30 30 10 10 30 30 10 030 30 30 - Dose Level: 100 10 _ 30 10 30 30 30 10 10 10 10 - Dosage Unit: ppm MeFOS +_ -- +- -- -- +- -- + ++- _ - " Dosage Unit: ppm MeFOS - ++ - ++ + + - - +++ + _ - _ + ++ - _ - - _ - Covance 6329-225 3M T-6314.1 004828 281 I 004829 ANIMAL NUMBER Appendix 5 Individual Clinical Urinalysis Data Males Week 14 13-WEEK 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 COMMENTS APP1 Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 Dose Level: 0 00 11 00 00 00 00 00 41 01 00 Dose Level: 3 01 00 00 00 01 00 01 00 00 01 Dosage Unit: ppm MeFOS 0 30 130 130 120 130 120 010 130 120 120 Dosage Unit: ppm MeFOS 120 120 120 120 020 130 120 130 130 120 1B4D 4D 4D 2B4D 0 4D 3D 4D 2B1D 4D 4D 3D 3D 4D 3D 4D 1B4D 4D 4D 2D BJ BJ BJ BK BJ BJ CJ BJ BJ CJ BKM BJ BJ BJ BJ BJ BJ BJ BJ BJ P PQ PQ PQ P PQ - PQ QR Q PQ Q PQ P P Q Q PQ PQ Q Covance 6329-225 3M T-6314.1 ANIMAL NUMBER Appendix 5 Individual Clinical Urinalysis Data Males Week 14 13-WEEK 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 COMMENTS APP1 Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 Dose Level: 30 00 01 01 00 00 00 01 01 00 00 Dose Level: 100 01 00 00 00 00 20 00 40 00 01 Dosage Unit: ppm MeFOS 030 110 020 020 120 120 010 130 110 120 Dosage Unit: ppm MeFOS 010 120 120 110 130 120 130 000 120 120 2B3D 4D 3D 4D 4D 4D 0 4D 4D 3D 0 4D 2D 4D 4D 4D 4D 0 4D 3D BJ BJ BJ BJ BJ BJ AJ BJ CJ BJ AJ BJ BJ BJ BJ BJ AJ AJ BJ BJ QR PQ Q PQ PQ PQ PQ PQ PQ Q Q Q PQ PQ PQ Q PQ Q Covance 6329-225 3M T-6314.1 004830 283 Appendix 5 Individual Clinical Urinalysis Data Females Meek 14 13-WEEK 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 C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 MEAN S.D. N Dose Level:: 0 4.3 17.5 25.6 36.0 4.3 41.0 2.6 24.3 5.8 8.2 1.027 1.010 1.006 1.005 1.027 1.002 1.034 1.008 1.023 1.017 17.0 14.13 10 1.016 .0112 10 Dose Level: 3 3.1 8.2 2.3 7.6 30.4 26.1 12.2 3.8 9.1 1.027 1.022 1.036 1.022 1.006 1.006 1.015 1.028 1.014 11.4 10.11 9 1.020 .0102 9 Dosage 6.5 7.0 7.0 6.5 6.5 6.5 6.5 7.0 6.5 7.0 6.7 .26 10 Dosage 6.5 6.5 6.5 7.5 6.5 7.5 6.5 6.5 7.0 6.8 .44 9 ppm MeFOS ppm MeFOS Covance 6329-225 3M T-6314.1 284 i Appendix 5 Individual Clinical Urinalysis Data Females Meek 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER U VOL ML SP GR U PH Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 MEAN S.D. N Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C9605Q C96056 C96060 MEAN S.D. N Dose Level: 30 9.0 9.9 22.1 41.5 2.4 43.8 6.3 7.6 11.3 12.8 1.021 1.019 1.009 1.004 1.030 1.006 1.025 1.020 1.016 1.013 16.7 14.62 10 1.016 .0084 10 Dose Level: 100 7.0 2.4 19.0 7.2 18.7 18.0 5.3 9.1 40.5 29.5 1.029 1.039 1.014 1.026 1.010 1.012 1.024 1.026 1.004 1.007 15.7 12.05 10 1.019 .0113 10 Dosage 7.0 6.5 6.5 7.0 6.5 6.5 7.0 6.5 7.0 7.0 6.8 .26 10 Dosage 6.5 6.5 6.5 6.5 6.5 6.5 6.5 6.5 7.0 7.0 6.6 .21 10 ppm MeFOS ppm MeFOS Covance 6329-225 3M T-6314.1 004832 285 i Appendix 5 Individual Clinical Urinalysis Data Females Week 14 13-WEEK 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 C95983 C959B4 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 Dose Level : 0 30 00010 030 010 10 - Dose Level : 3 10 10 10 10 010 10 10 0- Dosage Unit: ppm MeFOS --- -- - -- - --- - -- -- - -- "- - - - -- --" Dosage Unit: ppm MeFOS --- - -- -- -- - ---- --- --- --- - - - - - - - - - - - Covance 6329-225 3M T-6314.1 004833 286 Appendix 5 Individual Clinical Urinalysis Data Females Week 14 13-WEEK 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: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 Dose Level: 30 10 _ 010 010 10 10 10 10 0- Dose Level: 100 10 _ 30 10 10 010 10 10 00- Dosage Unit: ppm MeFOS -_---- ----------- - -- Dosage Unit: ppm MeFOS ------- -------------- _ - . - Covance 6329-225 3M T-6314.1 004834 287 I ANIMAL NUMBER Appendix 5 Individual Clinical Urinalysis Data Females Week 14 13-WEEK 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 COMMENTS APP1 Group: 1 Dose Level : 0 Dosage Unit;: ppm MeFOS C95983 0 1 1 2 0 2D BJ - C95984 0 0 1 1 0 ID AJ - C95985 0 0 0 1 0 0 AJ - C95986 0 1 1 1 0 0 AJ - C95987 0 1 1 2 0 4D BJ P C95988 0 0 1 3 0 4D AJ - C95990 0 0 1 1 0 2D BJ P C95996 0 0 0 1 0 2D AJ - C95997 0 0 1 3 0 4D BJ P C96000 0 0 1 1 0 4D BJ - Group: 2 Dose Level : 3 Dosage Unit:: ppm MeFOS C96001 0 0 1 1 0 4D BJ P C96002 0 0 1 2 0 4D BJ P C96003 0 0 1 3 0 4D BJ P C96006 0 1 1 2 0 4D BJ P C96007 0 0 0 1 0 0 AJ - C96008 0 0 1 3 0 ID AJ - C96010 0 1 1 2 0 0 BJ P C96019 0 0 1 1 0 4D BJ - C96020 0 0 0 1 0 2D BJ " Covance 6329-225 3M T-6314.1 004835 288 ANIMAL NUMBER Appendix 5 Individual Clinical Urinalysis Data Females Week 14 13-WEEK 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 COMMENTS APPI Group: 3 Dose Level : 30 Dosage Unit: ppm MeFOS C96021 0 1 1 2 0 4D BJ P C96022 0 0 0 1 0 3D BJ C96023 0 0 1 1 0 0 AJ - C96024 1 0 1 1 0 0 AJ C96025 0 0 1 1 0 0 BJ - C96026 0 0 1 1 0 IB AJ - C96027 0 1 1 2 0 4D BJ P C96030 0 1 1 1 0 0 BJ - C96038 0 0 1 2 0 0 BJ C96040 0 0 1 1 0 0 BJ P Group : 4 Dose Level : 100 Dosage Unit: ppm MeFOS C96042 0 0 1 1 0 2D BJ - C96044 0 1 0 2 0 ID BJ - C96045 0 0 1 2 0 0 AJ C96046 0 1 1 2 0 4D BJ P C96047 0 1 1 1 0 IB AJ - C96048 0 0 1 1 0 0 BJ P C96049 0 0 1 2 0 4D BJ P C96050 0 1 1 2 0 4D BJ - C96056 0 0 0 2 0 0 AJ C96060 0 0 1 1 0 0 AJ Covance 6329-225 3M T-6314.1 289 APPENDIX 6 Individual Animal Pathology Data Covane* 6329-225 3M T-6314.1 '290F* 004837 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 1 ANIMAL NUMBER: C95901 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 477.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:16 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0507 2.1637 3.6235 13.2353 .6399 3.0353 .3522 .0353 .0106 .4528 % .7582 % 2.7695 % .1339 % .6351 % .0737 % .0074 % .0234 1.0000 1.6747 6.1170 .2957 1.4028 .1628 .0163 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL HEART (HT) : -DEGENERATION/NECROSIS,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PANCREAS (PA) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 291 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 2 ANIMAL NUMBER: C95901 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 477.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:16 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), MUSCLE, SKELETAL (SM),NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 8, i 004839 292 I APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 3 ANIMAL NUMBER: C95902 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 500.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:38 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0754 2.1335 4.1240 15.9820 .8310 3.5597 .2540 .0198 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0151 % .4262 % .8238 % 3.1926 % .1660 % .7111 % .0507 % .0040 % ORGAN TO BRAIN WEIGHT RATIO .0353 1.0000 1.9330 7.4910 .3895 1.6685 .1191 .0093 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY THYMUS (TH) : -MOTTLED; BILATERAL: RED AND TAN LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL KIDNEY (KD) : -MINERALIZATION, TUBULAR,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC, -SLIGHT i O frS frQ Q 293 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 4 ANIMAL NUMBER: C 95902 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 500.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:38 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL. MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU),PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SALIV GL, MANDIB(SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL(AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 1 004841 294 I APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 5 ANIMAL NUMBER: C95903 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/9B STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 482.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:07 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0585 2.1393 3.4896 13.3362 .8041 3.5494 .2730 .0280 .0121 % .4431 % .7228 % 2.7623 % .1665 % .7352 % .0565 % .0058 % .0273 1.0000 1.6312 6.2339 .3759 1.6591 .1276 .0131 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LN, MANDIBULAR (MN) : -MOTTLED; BILATERAL: RED AND TAN GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LUNG (LU) : -HEMORRHAGE,-MINIMAL -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYROID (TY) : -ECTOPIC THYMUS,-PRESENT LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL SKIN (SK) : -EXUDATE, EPIDERMAL SURFACE,-MINIMAL -INFLAMMATION, SUBACUTE,-MINIMAL 004842 295 j APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 6 ANIMAL NUMBER: C95903 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 482.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:07 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM),NERVE, SCIATIC(SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 4 004S43 296 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 7 ANIMAL NUMBER: C95904 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 502.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:07 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0551 2.2087 4.1957 14.9025 .8734 3.4791 .3279 .0119 .0110 % .4393 % .8345 % 2.9639 % .1737 % .6919 % .0652 % .0024 % .0249 1.0000 1.8996 6.7472 .3954 1.5752 .1485 .0054 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY THYROID (TY) : >NOTE: TRIM COMMENT: ONE MISSING AT TIME OF TRIMMING PARATHYROID (PT) : >NOTE:>TRIM COMMENT: ONE MISSING AT TIME OF TRIMMING c LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL KIDNEY (KD) : -BASOPHILIC TUBULES, CORTEX,-MINIMAL -THICKENING, BASEMENT MEMBRANE,-MINIMAL HEART (HT) : -DEGENERATION/NECROSIS,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -ONE EXAMINED,-PRESENT PARATHYROID (PT) : -ONE EXAMINED,-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 04844 297 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3H T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 8 ANIMAL NUMBER: C95904 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 502.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:07 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER NECROPSY O B S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) SfrS'froo j 298 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 9 ANIMAL NUMBER: C95905 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 477.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:03 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0413 2.1962 3.2242 13.4331 .8531 3.1958 .3319 .0209 .0086 % .4596 % .6748 % 2.8114 % .1785 % .6689 % .0695 % .0044 % .0188 1.0000 1.4681 6.1165 .3884 1.4551 .1511 .0095 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 10 ANIMAL NUMBER: C95905 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 477.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:03 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW. FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN). SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB) , SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 004847 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 11 ANIMAL NUMBER: C95906 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 532.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:06 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0596 2.2070 3.6715 17.6850 .9226 3.5489 .2941 .0273 .0112 t .4146 % .6897 % 3.3224 t .1733 % .6667 % .0553 % .0051 % .0270 1.0000 1.6636 8.0131 .4180 1.6080 .1333 .0124 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PANCREAS (PA) : -PIGMENT, BROWN,-MINIMAL 301 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 12 ANIMAL NUMBER: C95906 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 532.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:06 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY),BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY),BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) i 004849 302 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 13 ANIMAL NUMBER: C95907 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 469.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:56 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0456 2.1146 3.3900 12.7160 .6803 3.1705 .3000 .0298 .0097 % .4507 % .7225 % 2.7101 % .1450 % .6757 % .0639 % .0064 % .0216 1.0000 1.6031 6.0134 .3217 1.4993 .1419 .0141 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GO : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PANCREAS (PA) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -PIGMENT, BROWN,-MINIMAL RECTUM (RE) : -PARASITISM,-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL 004850 303 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 14 ANIMAL NUMBER: C95907 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 469.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:56 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 004551 304 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 15 ANIMAL NUMBER: C95908 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 505.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7: 36 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0571 2.1256 3.4921 13.0677 .8254 3.3149 .5078 .0193 .0113 % .4209 % .6915 % 2.5877 % .1634 % .6564 % .1006 % .0038 % .0269 1.0000 1.6429 6.1478 .3883 1.5595 .2389 .0091 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN THYROID (TY) ; -CYST, ULTIMOBRANCHIAL,-PRESENT LN, MANDIBULAR (MN) : -HEMORRHAGE, -MINIMAL PROSTATE (PR) -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 004852 305 ! !f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 16 ANIMAL NUMBER: C95908 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 505.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:36 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW. STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 004853 306 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 17 ANIMAL NUMBER: C95909 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 434.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:29 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0629 2.1932 3.1195 11.3174 .6744 3.6084 .3922 .0256 .0145 % .5053 % .7188 % 2.6077 % .1554 % .8314 % .0904 % .0059 % .0287 1.0000 1.4224 5.1602 .3075 1.6453 .1788 .0117 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT HARDERIAN GLAND (HG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 004854 307 ! APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 18 ANIMAL NUMBER: C95909 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 434.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:29 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM),NERVE, SCIATIC(SN), SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ' 004855 308 I 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 19 ANIMAL NUMBER: C95910 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 573.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:54 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) (TT) .0412 2.2483 4.4547 16.2577 .8328 3.6513 .5244 .0345 .0072 % .3918 % .7764 % 2.8333 t .1451 % .6363 % .0914 % .0060 % NECROPSY O B S E R V A T I C )N S ORGAN TO BRAIN WEIGHT RATIO .0183 1.0000 1.9814 7.2311 .3704 1.6240 .2332 .0153 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN HISTOPATHOLOGY GENERAL COMMENT (G C ) : -B O N E MARROW SM EAR T A K E N -N O M ACRO SCOPIC L E S IO N S LUNG (L U ) : -I N F IL T R A T E , MACROPHAGE, A L V E O L A R ,-M IN IM A L -M IN E R A L IZ A T IO N , V A S C U L A R ,-M IN IM A L LIV ER (L I ) : -IN F IL T R A T E , L Y M P H O H IS T IO C Y T IC ,-M IN IM A L K ID N EY (K D ) : -B A S O P H IL IC T U B U L E S , C O R T E X ,-M IN IM A L TH YRO ID (T Y ) : -C Y S T , U LTIM O BR A N C H IA L, - PR ESEN T -IN F IL T R A T E , L Y M P H O H IS T IO C Y T IC ,-M IN IM A L PROSTATE (P R ) : -IN F IL T R A T E , L Y M P H O H IS T IO C Y T IC ,-M IN IM A L 004856 309 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 20 ANIMAL NUMBER: C95910 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 573.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:54 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE P O S T - F I X WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOW ING ORGANS WERE UNREMARKABLE A T N E C R O PSY : BONE, FEMUR ( F E ) , MARROW, FEMUR (F M ), MARROW, STERNUM ( S E ) , B O N E , STERNUM ( S B ) , E Y E ( E Y ) , B R A IN ( B R ) , SP IN A L CORD ( S C ) , LUNG (L U ), TRACHEA (T R ) , ESOPHAGUS ( E S ) , L IV E R ( L I ) , K IDNEY (K D ), HEART (H T ), M USCLE, SKELETAL (S M ), N ERV E, S C IA T IC ( S N ) , SPL E E N ( S P ) , THYMUS ( T H ) , L N , M ESEN TER IC (M S ), TH Y R O ID ( T Y ) , PARATH YROID ( P T ) , ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (M A ), AORTA (A O ), P IT U IT A R Y ( P I ) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , PANCREAS ( P A ) , DUODENUM (D U ), JEJUNUM ( J E ) , ILEUM ( I L ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ) , L N , M ANDIBULAR <M N ), S A L IV G L , M ANDIB (S G ) , H A R D ER IA N GLAND (H G ) , A U D IT O R Y S E B GL ( A S ) , S K IN (S K ) , U R IN A R Y BLADDER (U B ) , PR O STA TE ( P R ) , SEM INAL V E SIC L E S ( S V ) , T E S T IS ( T E ) , E P ID ID Y M ID E S ( E P ) , T A IL (T I ) THE FOLLOW ING T I S S U E S WERE UNREMARKABLE AT M IC R O SC O P IC E X A M IN A T IO N : BONE, FEMUR ( F E ) , MARROW, FEMUR (F M ), MARROW, STERNUM ( S E ) , B O N E , STERNUM ( S B ) , EY E ( E Y ) , B R A IN ( B R ) , SPIN A L CORD (S C ), TRACHEA (T R ), ESOPHAGUS ( E S ) , HEART (H T ), MUSCLE, SKELETAL (S M ), NERVE, S C IA T IC (S N ), S P L E E N ( S P ) , THYM US ( T H ) , L N , M E SE N T E R IC ( M S ) , PA R A T H Y R O ID ( P T ) , A D R E N A L , C ORTEX ( A C ) , A D R E N A L , M EDULLA (M A) , AORTA (A O ), P IT U IT A R Y ( P I ) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , PANCREAS (P A ) , DUODENUM (D U ), JEJU NU M ( J E ) . ILEUM ( I L ) , CECUM ( C E ) , COLON ( C O ), RECTUM ( R E ) , L N , M ANDIBULAR (M N ), S A L IV G L , M A N DIB ( S G ) , H A R DER IAN GLAND (H G ), AUDITO RY SE B GL ( A S ) , S K IN ( S K ) , U R IN A R Y BLADDER ( U B ) , SEM IN A L V E S IC L E S ( S V ) , T E S T IS ( T E ) , E P ID ID Y M ID E S (E P ) 4 S 8 0 0 310 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 21 ANIMAL NUMBER: C95911 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 324.5 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:59 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 9.9529 ----------------------------- ---------------------- 3.0671 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) i 004858 311 I i f Il APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 22 ANIMAL NUMBER: C95912 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 376.3 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:31 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STA T U S ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 12.7772 ----------------------------- ---------------------- 3.3955 % ----------------------------- ---------------------.....-- ------- ---------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC> 04S59 312 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 23 ANIMAL NUMBER: C95913 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 367.1 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:45 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 11.6383 ----------------------------- ---------------------- 3.1703 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) 004860 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 24 ANIMAL NUMBER: C95914 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 346.2 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:36 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 11.8655 ----------------------------- ---------------------- 3.4274 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) 004S61 314 ( APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 25 ANIMAL NUMBER: C95915 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 262.0 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:42 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ORGAN NAME A BSO LUT E ORGAN W EIGHT (G R A M S) ORGAN W EIGHT R E L A T IV E TO BODY W EIG H T (% ) ORGAN TO BR A IN W EIGHT R A T IO ORGAN STATUS ADRENAL (A D ) BR AIN (B R ) K ID NEY (K D ) LIVER (LI) SPLEEN (SP) T E S T IS (T E ) THYMUS (T H ) T H Y R O ID /PA R A T H Y R (T T ) -------------------- --------------------------------------- 7.5432 -------- ---------------------------------------------------------- -------------------- --------------------------------------- 2.8791 -------- ---------------------------------------------------------- % -------------------- --------------------------------------- --------------- ---------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOW ING ORGANS WERE UNREMARKABLE A T N E C R O PSY : B O N E , FEMUR ( F E ) , MARROW, FEMUR (F M ), MARROW, STERNUM ( S E ) , B O N E , STERNUM ( S B ) , EY E ( E Y ) , B R A IN (B R ) , S P IN A L CORD ( S C ) , LUNG (L U ), TRACHEA (T R ), ESOPHAGUS ( E S ) , L IV E R ( L I ) , K ID NEY (K D ), HEART (H T ), M USCLE, SKELETAL (S M ), N ER V E, S C IA T IC ( S N ) , SPL E E N ( S P ) , THYMUS ( T H ), L N , M ESEN TER IC (M S ), TH Y R O ID ( T Y ) , PARATH YROID ( P T ) , ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (M A ), AORTA (A O ), P IT U IT A R Y ( P I ) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , PANCREAS ( P A ) , DUODENUM ( D U ) , JE JU N U M ( J E ) , ILEUM ( I L ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ) , L N , M ANDIBULAR (M N) , S A L IV G L , M A N DIB (S G ) , H A R DER IAN GLAND (H G ) , A U D IT O R Y S E B GL ( A S ) , S K IN (S K ) , U R IN A R Y BLADDER (U B ) , PR O STA TE ( P R ) , SE M IN A L V E S IC L E S ( S V ) , T E S T I S ( T E ) , E P ID ID Y M ID E S ( E P ) , T A IL ( T I ) , G EN ER AL COMMENT (G C ) APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 26 A **-b W' cyrj>i u ANIMAL NUMBER: C95916 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 557.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:32 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0570 2.3125 4.2219 15.3513 .8545 3.7162 .3622 .0252 .0102 % .4145 % .7567 % 2.7516 % .1532 % .6661 % .0649 % .0045 % .0246 1.0000 1.8257 6.6384 .3695 1.6070 .1566 .0109 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY KIDNEY (KD) : -LARGE PELVIS(ES); RIGHT THYMUS (TH) : -RED FOCUS(I)/AREA<S); DIFFUSE: MULTIPLE DARK RED AREAS, TO 3 X 2 MM STOMACH, GL (ST) : NOTE:TRIMMING COMMENT: STOMACH NOT FOUND IN WET TISSUE STOMACH, NONGL (SU) : NOTE:TRIMMING COMMENT: STOMACH NOT FOUND IN WET TISSUE UP DUODENUM (DU) : NOTE:TRIMMING COMMENT: DUODENUM NOT FOUND IN WET TISSUE LUNG (LU) : -INFLAMMATION, SUBACUTE,-MINIMAL KIDNEY (KD) : -DILATATION, PELVIC,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL STOMACH, GL (ST) : TISSUE MISSING STOMACH, NONGL (SU) : TISSUE MISSING PANCREAS (PA) : -INFLAMMATION, CHRONIC-ACTIVE,-SLIGHT DUODENUM (DU) : TISSUE MISSING PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 316 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 27 ANIMAL NUMBER: C95916 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 557.9 GRAMS D A T E AND TIME OF NECROPSY: 12/02/98 8:32 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD NECROPSY OBSERVATIONS (C O N T IN U E D ) HISTOPATHO LOG Y GENERAL COMMENT (G C ) : -B O N E MARROW SM EA R TA K EN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN. MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB) , PROSTATE SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) (PR), THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), LIVER(LI),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), JEJUNUM (JE),ILEUM (IL), CECUM (CE),COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 004864 317 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 28 ANIMAL NUMBER: C95917 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 531.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:37 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) B R A I N (BR) K ID NEY (K D ) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0545 2.0848 4.3299 13.8740 .7099 3.4976 .3380 .0278 .0102 % .3920 % .8140 % 2.6084 % .1335 % .6576 % .0635 % .0052 % .0261 1.0000 2.0769 6.6548 .3405 1.6777 .1621 .0133 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LUNG (LU) : -MINERALIZATION,VASCULAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT RECTUM (RE) : -PARASITISM.-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT j t, )'. 'i 004865 318 I i f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 29 ANIMAL NUMBER: C95917 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 531.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:37 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM), NERVE, SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) SCIATIC(SN), i 4 004866 319 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 30 ANIMAL NUMBER: C95918 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 494.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:58 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0547 2.0931 3.6402 14.9341 .7976 3.2582 .2806 .0265 .0111 % .4231 % .7358 % 3.0188 % .1612 % .6586 % .0567 % .0054 % .0261 1.0000 1.7391 7.1349 .3811 1.5566 .1341 .0127 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY THYMUS (TH) : -RED FOCUS(I)/AREA(S); DIFFUSE: TO 3 X 2 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN MULTIPLE DARK RED AREAS, UP LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL 004867 320 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 31 ANIMAL NUMBER: C95918 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 494.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:58 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM),NERVE, SCIATIC(SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 1 004868 321 I APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 32 ANIMAL NUMBER: C95919 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 523.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:30 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0603 2.2555 4.1905 16.3018 .9470 3.1638 .2340 .0308 .0115 % .4305 % .7999 % 3.1116 % .1808 % .6039 % .0447 % .0059 % .0267 1.0000 1.8579 7.2276 .4199 1.4027 .1037 .0137 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LN, MANDIBULAR (MN) : -DIFFUSELY RED; RIGHT: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL HEART (HT) : -DEGENERATION/NECROSIS,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PARATHYROID (PT) : -CYST,-PRESENT PITUITARY (PI) : -CYST,-PRESENT LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 004869 322 APPENDIX 6 individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 33 ANIMAL NUMBER: C95919 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 523.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:30 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW. FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE,SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TV), PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), MUSCLE, SKELETAL(SM), NERVE,SCIATIC SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) (SN), 004870 323 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULiFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 34 ANIMAL NUMBER: C95920 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 514.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:35 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO O RGAN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0685 2.1808 4.1319 15.1321 .8162 3.1121 .4094 .0193 .0133 % .4241 % .8036 % 2.9428 t .1587 % .6052 % .0796 % .0038 % .0314 1.0000 1.8947 6.9388 .3743 1.4270 .1877 .0088 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVAT ION S HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL i 004871 324 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 35 ANIMAL NUMBER: C95920 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 514.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:35 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 1 004872 325 I ! ,4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N- METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 36 ANIMAL NUMBER: C95921 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 478 .4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:11 !PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE 1PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0513 2.2655 3.4063 13.6319 .7113 3.1045 .2703 .0315 .0107 % .4736 % .7120 % 2.8495 % .1487 % .6489 % .0565 % .0066 % .0226 1.0000 1.5036 6.0172 .3140 1.3703 .1193 .0139 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY THYMUS (TH) : -DIFFUSELY RED; LEFT LOBE: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-SLIGHT THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004873 326 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 37 ANIMAL NUMBER: C95922 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 486.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:30 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0448 2.1727 3.4077 13.7456 .7358 3.6580 .2339 .0446 .0092 % .4463 % .7000 % 2.8237 % .1512 % .7514 % .0480 % .0092 % .0206 1.0000 1.5684 6.3265 .3387 1.6836 .1077 .0205 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE. FEMUR (FE), MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004874 327 ( I APPENDIX 6 Covance 6329-225 3M T-6314.1 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 38 ANIMAL NUMBER: C95923 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 491.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:47 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0499 2.1488 4.0171 13.8730 .6287 3.6620 .3346 .0122 .0101 % .4370 % .8170 % 2.8214 % .1279 % .7448 % .0680 % .0025 % .0232 1.0000 1.8695 6.4562 .2926 1.7042 .1557 .0057 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) i 004875 328 I i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 39 ANIMAL NUMBER: C95924 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 498.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:45 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0561 2.1774 3.7379 13.9536 .9245 3.5483 .3028 .0248 .0113 % .4367 % .7497 % 2.7986 % .1854 % .7117 % .0607 % .0050 % .0258 1.0000 1.7167 6.4084 .4246 1.6296 .1391 .0114 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004876 329 ( APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 40 ANIMAL NUMBER: C95925 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 468.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:10 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0628 2.2194 3.9763 14.6970 .6523 3.1815 .2829 .0261 .0134 % .4739 % .8491 % 3.1384 % .1393 % .6794 % .0604 % .0056 % .0283 1.0000 1.7916 6.6221 .2939 1.4335 .1275 .0118 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY STOMACH, GL (ST) : -LIGHT FOCUS(I )/AREA(S ); MUCOSA, NEAR ESOPHAGEAL GROVE SINGLE WHITE, SLIGHTLY RAISED AREA, 1 MM IN DIAMETER LN. MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL STOMACH, GL (ST) : UNREMARKABLE LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT i 004877 330 i .4 IJi APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 41 ANIMAL NUMBER: C95925 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 468.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:10 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) ii. } 4 C' c *& Gl vi oo 331 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 42 ANIMAL NUMBER: C95926 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 438.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:19 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0518 1.9876 2.8500 11.7726 .6868 2.7873 .3553 .0163 .0118 % .4531 % .6496 % 2.6835 % .1566 % .6354 % .0810 % .0037 % .0261 1.0000 1.4339 5.9230 .3455 1.4023 .1788 .0082 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004879 332 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 43 ANIMAL NUMBER: C95927 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 469.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:50 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ADRENAL (AD) B R A I N (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0504 2.1110 4.0122 14.9670 .6945 3.0365 .3438 .0230 .0107 % .4497 % .8548 % 3.1885 % .1480 % .6469 % .0732 % .0049 % .0239 1.0000 1.9006 7.0900 .3290 1.4384 .1629 .0109 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: AREA, 3 X 1 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN SINGLE DARK BROWN LINEAR LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL STOMACH, GL (ST) : -EROSION,-SLIGHT THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004880 333 I i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314,1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 44 ANIMAL NUMBER: C95928 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 486.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:23 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0537 2.0720 3.6794 14.1057 .5995 3.4858 .2143 .0300 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0110 % .4262 % .7569 t 2.9018 % .1233 % .7171 % .0441 % .0062 % ORGAN TO BRAIN WEIGHT RATIO .0259 1.0000 1.7758 6.8078 .2893 1.6823 .1034 .0145 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS H IST O PA T H O L O G Y G ENERAL COMMENT (G C ) : -B O N E MARROW SM EAR TA K EN -N O M ACRO SCOPIC L E S IO N S LIV ER (L I ) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004881 334 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 45 ANIMAL NUMBER: C95929 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 505.5 GRAMS D A T E AND TIME OF NECROPSY: 12/02/98 8:20 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO O RGA N STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0687 2.1644 3.1590 13.3939 .8459 3.7218 .2340 .0298 .0136 % .4282 .6249 2.6496 % .1673 % .7363 % .0463 % .0059 % .0317 1.0000 1.4595 6.1883 .3908 1.7196 .1081 .0138 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0 BSERVATIONS HISTOPATHOLOGY THYMUS (TH) : -RED FOCUS(I)/AREA(S); RIGHT 3 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LOBE: SINGLE DARK RED AREA,, 6 X LIVER (LI) : -INFILTRATE , LYMPHOHISTIOCYTIC,-SLIGHT -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) -HEMORRHAGE ,-SLIGHT THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 0048S2 335 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 46 ANIMAL NUMBER: C95930 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 484,.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:59 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0711 2.0340 3.8914 15.3859 .8442 3.4684 .4143 .0169 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0147 % .4202 t .8040 % 3.1789 % .1744 % .7166 % .0856 % .0035 % ORGAN TO BRAIN WEIGHT RATIO .0350 1.0000 1.9132 7.5644 .4150 1.7052 .2037 .0083 ORGAN STA T U S WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0BS ERVA T ION S HISTOPATHOLOGY KIDNEY (KD) : -LARGE PELVIS(ES); LEFT -GRANULAR MATERIAL; LEFT , WITHIN PELVIS: MULTIPLE TAN, PINPOINT GRANULES GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-1MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE ,-MINIMAL KIDNEY (KD) : -DILATATION, PELVIC,-SLIGHT 004883 336 APPENDIX G individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 47 ANIMAL NUMBER: C95930 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 484.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:59 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM <SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) i 1 004884 337 I In APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 48 ANIMAL NUMBER: C95931 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 362.7 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:47 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 11.8205 ----------------------------- ---------------------- 3.2590 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) 338 I ( 4 t i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 49 ANIMAL NUMBER: C95932 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 329.1 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:42 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 9.9205 ----------------------------- ---------------------- 3.0144 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) 004886 339 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 50 ANIMAL NUMBER: C95933 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 341.3 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:44 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 11.2465 ----------------------------- ---------------------- 3.2952 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID <PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) r| ' f, } 0 0 4 SS7 340 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 51 ANIMAL NUMBER: C95934 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 317.0 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:58 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 9.9286 ----------------------------- ---------------------- 3.1321 % ----------------------------- ----------------------------- ----------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) . SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) 004888 341 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 52 ANIMAL NUMBER: C95935 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 354.6 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 12:07 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 11.8361 ----------------------------- ---------------------- 3.3379 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (Tl), GENERAL COMMENT (GC) 342 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 53 ANIMAL NUMBER: C95936 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 550.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:51 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0484 2.0694 4.1177 15.6498 .7959 3.1581 .3262 .0188 .0088 .3756 % .7474 % 2.8408 % .1445 % .5733 % .0592 % .0034 t .0234 1.0000 1.9898 7.5625 .3846 1.5261 .1576 .0091 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; LEFT, UPPER INCISOR LIVER (LI) : -INFILTRATE,LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUALHEPATOCYTE,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) l E< fi i 004890 343 I i * I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 54 ANIMAL NUMBER: C95937 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 444.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:10 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO O RGA N STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0662 2.2591 3.7504 16.6721 .8440 3.2365 .3431 .0289 .0149 % .5082 % .8437 % 3.7508 % .1899 % .7281 % .0772 % .0065 % .0293 1.0000 1.6601 7.3800 .3736 1.4327 .1519 .0128 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID <PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004891 344 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 55 ANIMAL NUMBER: C95938 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 497.6 GRAMS D A T E AND TIME OF NECROPSY: 12/02/98 7:59 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO o w o AN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0579 2.1368 4.1230 16.5589 .5647 3.6229 .3002 .0272 .0116 % .4294 % .8286 3.3278 % .1135 % .7281 % .0603 % .0055 % .0271 1.0000 1.9295 7.7494 .2643 1.6955 .1405 .0127 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVAT ION S HISTOPATHOLOGY GENERAL COMMENT (G C ) : -B O N E MARROW SM EA R T A K E N -N O M ACRO SCO PIC L E S IO N S LIV ER (L I ) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDER IAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004892 I 345 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 56 ANIMAL NUMBER: C95939 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 447.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:23 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0634 2.3237 3.6350 12.6033 1.1088 3.2485 .4355 .0289 .0142 % .5189 % .8117 % 2.8145 % .2476 % .7254 % .0973 % .0065 % .0273 1.0000 1.5643 5.4238 .4772 1.3980 .1874 .0124 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP) , THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004893 346 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 57 ANIMAL NUMBER: C95940 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 483.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:10 PROSECTOR: KIMBERLY DURLAND RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0659 2.1363 4.1869 14.1874 .8620 3.8586 .2849 .0224 .0136 % .4422 % .8667 % 2.9367 % .1784 % .7987 % .0590 % .0046 % .0308 1.0000 1.9599 6.6411 .4035 1.8062 .1334 .0105 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL UPPER INCISORS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE ,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE, --SLIGHT THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 004894 347 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 58 ANIMAL NUMBER: C95941 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 411.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:42 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .04 57 2.1186 3.5249 13.6671 .8387 3.2827 .3528 .0182 .0111 % .5148 % .8566 % 3.3213 % .2038 % .7977 % .0857 % .0044 % .0216 1.0000 1.6638 6.4510 .3959 1.5495 .1665 .0086 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -FIBROSIS, CAPSULAR,-MINIMAL -HYPERTROPHY, HEPATOCELLULAR,CENTRI LOBULAR, -MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL j ' f> i 004895 348 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 59 ANIMAL NUMBER: C95941 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 411.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:42 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 4 004S96 I 349 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 60 ANIMAL NUMBER: C95942 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 418.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:58 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0694 2.0705 4.1159 14.8588 .6815 3.5997 .2568 .0174 .0166 % .4945 % .9830 % 3.5488 % .1628 % .8597 % .0613 % .0042 % .0335 1.0000 1.9879 7.1764 .3291 1.7386 .1240 .0084 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL LN, MANDIBULAR (MN) ; -HEMORRHAGE,-SLIGHT 004897 350 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 61 ANIMAL NUMBER: C95942 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 418.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:58 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) f 004898 I 351 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 62 ANIMAL NUMBER: C95943 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 500.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:21 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0531 2.1128 4.1504 19.4681 .6715 3.5995 .3527 .0275 .0106 % .4225 % .8299 % 3.8928 % .1343 % .7198 % .0705 % .0055 % .0251 1.0000 1.9644 9.2144 .3178 1.7037 .1669 .0130 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, DIFFUSE,-MINIMAL j " j, 1 004899 352 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 63 ANIMAL NUMBER: C95943 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 500.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:21 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 004300 353 i 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.I 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 64 ANIMAL NUMBER: C95944 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 433.2 GRAMS D A T E AND TIME OF NECROPSY: 12/02/98 11:31 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0511 2.1737 3.9789 15.6049 .6847 3.4797 .2276 .0265 .0118 % .5018 % .9185 % 3.6022 % .1581 % .8033 % .0525 % .0061 % .0235 1.0000 1.8305 7.1790 .3150 1.6008 .1047 .0122 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT 004901 354 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 65 ANIMAL NUMBER: C95944 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 433.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:31 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG>, AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB>, PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 1 004902 S 355 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 66 ANIMAL NUMBER: C95945 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 491.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:17 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0502 2.1630 4.1701 17.2249 .6713 3.8878 .2839 .0216 .0102 % .4403 % .8488 % 3.5060 % .1366 % .7913 % .0578 % .0044 t .0232 1.0000 1.9279 7.9634 .3104 1.7974 .1313 .0100 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, DIFFUSE,-MINIMAL 004903 i 356 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 67 ANIMAL NUMBER: C95945 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 491.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:17 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) OGOQ I 357 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 68 ANIMAL NUMBER: C95946 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 469.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:59 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0648 2.3771 3.3029 15.7438 .7863 3.5288 .1989 .0365 .0138 % .5068 % .7042 % 3.3569 % .1677 % .7524 % .0424 % .0078 % .0273 1.0000 1.3895 6.6231 .3308 1.4845 .0837 .0154 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL SOG fr0 0 358 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 69 ANIMAL NUMBER: C95946 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 469.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:59 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO),.RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) ^ ^o o 359 1 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 70 ANIMAL NUMBER: C95947 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 449.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:45 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0507 2.1942 3.2317 15.1188 .8297 3.2832 .3773 .0232 .0113 % .4877 % .7183 % 3.3605 % .1844 % .7298 % .0839 % .0052 % .0231 1.0000 1.4728 6.8903 .3781 1.4963 .1720 .0106 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY THYMUS (TH) : -RED FOCUS(I)/AREA(S ); DIFFUSE: MULTIPLE DARK RED PINPOINT FOCI LN, MANDIBULAR (MN) : -MOTTLED: BILATERAL: DARK RED AND TAN GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE, -MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL ; 004907 360 * APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 71 ANIMAL NUMBER: C95947 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 449.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:45 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 80G & 0Q 361 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 72 ANIMAL NUMBER:.C95948 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 476.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:44 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0458 2.1430 3.6102 13.4487 .8221 3.2511 .3464 .0202 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0096 % .4499 % .7580 % 2.8236 % .1726 % .6826 % .0727 % .0042 % ORGAN TO BRAIN WEIGHT RATIO .0214 1.0000 1.6846 6.2756 .3836 1.5171 .1616 .0094 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY THYMUS (TH) : -DIFFUSELY RED; DARK RED LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN GENERAL INFORMATION (XX) : >NOTE:>ANIMAL IDENTIFICATION TRANSPONDER DAMAGED AT NECROPSY LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL THYMUS (TH) : -HEMORRHAGE,-SLIGHT LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT 4 004909 362 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 73 ANIMAL NUMBER: C95948 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 476.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:44 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) i i 00431 o I 363 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 74 ANIMAL NUMBER: C95949 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 421.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:44 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0562 2.0546 3.9393 14.9562 .7402 3.5816 .1584 .0219 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0133 % .4879 % .9355 % 3.5517 % .1758 % .8505 % .0376 % .0052 % ORGAN TO BRAIN WEIGHT RATIO .0274 1.0000 1.9173 7.2794 .3603 1.7432 .0771 .0107 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS -STAINS-PERINEUM/PERIANAL; YELLOW AND MOIST 004911 364 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) i n r a t s PAGE: 75 ANIMAL NUMBER: C95949 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 421.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:44 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY P O S T - F I X WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI),. STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), STOMACH, GL (ST), STOMACH, NONGL (SU) 4 004912 365 ( APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 76 ANIMAL NUMBER: C95950 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 467.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:29 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0593 2.2213 3.8346 15.5750 .6608 3.4323 .2306 .0259 .0127 % .4750 % .8201 % 3.3308 % .1413 % .7340 % .0493 % .0055 % .0267 1.0000 1.7263 7.0117 .2975 1.5452 .1038 .0117 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY ' THYMUS ' (TH) : -RED FOCUS(I)/AREA(S); BOTH LOBES: MULTIPLE DARK RED AREAS, UP TO 5 MM IN DIAMETER GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-SLIGHT -INVOLUTION,-MINIMAL 004913 366 ( APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 77 ANIMAL NUMBER: C95950 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 467.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:29 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL. MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 004914 367 I APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 78 ANIMAL NUMBER: C95951 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 381.8 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 12:06 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 13.6836 ---------------- .------------ ---------------------- 3.5840 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP) , THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) STGr 00 t 368 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 79 ANIMAL NUMBER: C95952 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 316.5 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:25 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 11.6980 ----------------------------- ---------------------- 3.6961 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) j i j, } 004916 369 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 80 ANIMAL NUMBER: C95953 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 326.4 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:13 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 11.6552 ----------------------------- ---------------------- 3.5708 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID <PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) TGfr 00 i 370 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 81 ANIMAL NUMBER: C95954 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 365.4 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:38 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 13.5081 ----------------------------- ---------------------- 3.6968 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) STG^OO 371 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 82 ANIMAL NUMBER: C95955 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 346.9 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:55 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) A BSO LU T E ORGAN W EIGHT (G R A M S) ---------------------- 15.0803 ----------------------------- ORGAN W EIGHT R E L A T IV E TO BODY W EIG H T (% ) ---------------------- 4.3472 % ----------------------------- ORGAN TO BR A IN W EIGHT R A T IO --------------------------------------------------------- ORGAN STATUS NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL. MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) j ' j. 4 004919 I 372 APPENDIX 6 individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 83 ANIMAL NUMBER: C95956 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 523.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:27 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0526 2.1420 3.8586 17.4646 .7985 2.7847 .3131 .0268 .0101 % .4093 % .7374 % 3.3374 % .1526 % .5321 % .0598 % .0051 % .0246 1.0000 1.8014 8.1534 .3728 1.3000 .1462 .0125 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR,CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL | " f, i 026-00 I 373 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 84 ANIMAL NUMBER: C95956 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 523.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:27 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) f T2G ^00 374 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 85 ANIMAL NUMBER: C95957 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 474.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:54 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0530 2.1797 4.2081 16.5473 .8376 3.8841 .2384 .0268 .0112 % .4592 % .8865 % 3.4858 % .1764 % .8182 % .0502 % .0056 % .0243 1.0000 1.9306 7.5915 .3843 1.7819 .1094 .0123 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,- MINIMAL Z Z G t0 0 i 375 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 86 ANIMAL NUMBER: C95957 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 474.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:54 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) %c^oo 376 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 87 A N IM A L NUMBER: C95958 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 471.3 GRAMS D A T E AND TIME OF NECROPSY: 12/02/98 10:40 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0509 2.1388 3.6164 16.8594 .7451 3.0781 .2885 .0212 .0108 % .4538 % .7673 % 3.5772 % .1581 % .6531 % .0612 % .0045 % .0238 1.0000 1.6909 7.8826 .3484 1.4392 .1349 .0099 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL t 'ZG frO O i 377 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 88 ANIMAL NUMBER: C95958 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E O F D E A T H : 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 471.3 GRAMS D A T E AND TIME OF NECROPSY: 12/02/98 10:40 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY P O S T - F I X WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) i i 00432S i 378 f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 89 ANIMAL NUMBER: C95959 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 443.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:39 PROSECTOR: KIMBERLY DURLAND RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0479 2.2347 3.6999 15.7371 .6008 3.2245 .2848 .0286 .0108 % .5040 % .8344 % 3.5492 % .1355 % .7272 % .0642 % .0065 % .0214 1.0000 1.6557 7.0422 .2689 1.4429 .1274 .0128 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY L N , M A N DIBU LAR (M N) : -D IF F U SE L Y RED; BILA TE R A L: GENERAL COMMENT (G C ) : -B O N E MARROW SM E A R T A K E N DARK RED LIV ER ( L I ) : -H Y PER TR O PH Y , H EPATO CELLULAR, C ENTR ILO BU LA R, -M IN IM A L -I N F IL T R A T E , L Y M P H O H IS T IO C Y T IC ,-M IN IM A L L N , M A N DIBULAR (M N) : -H E M O R R H A G E ,-M IN IM A L i 92Gfr00 379 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 90 ANIMAL NUMBER: C95959 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 443.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:39 PROSECTOR: KIMBERLY DURLAND RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 1 *ZGlr00 380 I S 4 I APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 91 ANIMAL NUMBER: C95960 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 449.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:43 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0760 2.1953 3.8855 16.2467 .6429 3.8243 .1769 .0243 .0169 % .4883 % .8642 % 3.6136 % .1430 % .8506 % .0393 % .0054 % .0346 1.0000 1.7699 7.4007 .2929 1.7420 .0806 .0111 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY THYMUS (TH) : -RED FOCUS(I )/AREA(S ); BOTH LOBES: MULTIPLE DARK RED PINPOINT FOCI GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL THYMUS (TH) : -HEMORRHAGE,-SLIGHT oo o to APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 92 ANIMAL NUMBER: C95960 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 449.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:43 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN). SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN). SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 62C fr00 I 382 APPENDIX 6 Individual Anatomic Pathology Data Covance G329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 93 ANIMAL NUMBER: C95961 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/90 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 483.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:53 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0572 2.3075 4.4633 27.5733 .7101 3.9981 .3288 .0241 .0118 % .4776 % .9239 % 5.7076 % .1470 % .8276 % .0681 % .0050 % .0248 1.0000 1.9343 11.9494 .3077 1.7327 .1425 .0104 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LIVER (LI) : -LARGE; ALL LOBES, MARGINS ROUNDED LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,SLIGHT THYMUS (TH) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL OCGfroo i 383 4 l APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 94 ANIMAL NUMBER: C95961 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 483.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:53 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM), NERVE,SCIATIC SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) , CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) (SN), 004331 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 95 ANIMAL NUMBER: C95962 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 428.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:31 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0573 2.1762 3.9386 21.3603 .6749 3.5204 .2975 .0265 .0134 % .5083 % .9200 % 4.9896 % .1577 % .8223 % .0695 % .0062 % .0263 1.0000 1.8099 9.8154 .3101 1.6177 .1367 .0122 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL HARDERIAN GLAND (HG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 004932 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 96 ANIMAL NUMBER: C95962 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 428.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:31 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR <MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) i 1 004933 386 l f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-22S 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 97 ANIMAL NUMBER: C95963 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 473.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:30 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0519 2.0730 3.9593 26.0579 .6285 3.4019 .2799 .0246 .0110 % .4381 % .8367 % 5.5067 % .1328 % .7189 % .0592 % .0052 % .0250 1.0000 1.9099 12.5701 .3032 1.6411 .1350 .0119 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LIVER (LI) : -LARGE; ALL LOBES THICKENED, MARGINS ROUNDED -DIFFUSELY DARK; ALL LOBES: DARK BROWN STOMACH, GL (ST) : -DARK FOCUS(I)/AREA(S); MUCOSA: SINGLE DARK BROWN FOCUS, MM IN DIAMETER 1 LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL STOMACH, GL (ST) : -EROSION,-SLIGHT PANCREAS (PA) : -ATROPHY, ACINAR,-MINIMAL -INFLAMMATION, CHRONIC-ACTIVE,-SLIGHT -PIGMENT, BROWN,-MINIMAL HARDERIAN GLAND (HG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 004934 387 ! APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 98 ANIMAL NUMBER: C95963 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 473.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:30 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD NECROPSY O B S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) , TAIL (TI) (PR), THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 004935 388 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 99 ANIMAL NUMBER: C95964 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 462.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:07 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0554 2.2840 4.5315 30.5553 .7488 3.8137 .2714 .0220 .0120 % .4934 % .9789 % 6.6008 % .1618 % .8239 % .0586 % .0048 % .0243 1.0000 1.9840 13.3780 .3278 1.6697 .1188 .0096 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -NECROSIS, COAGULATIVE,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL LN, MESENTERIC (MS) : -HEMORRHAGE,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 004936 389 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 100 ANIMAL NUMBER: C95964 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 462.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:07 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER NECROPSY O B S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL(SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM), NERVE, SCIATIC(SN), SPLEEN (SP), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) . AUDITORY SEB GL (AS), SKIN (SK) , SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 004937 390 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS PAGE: 101 ANIMAL NUMBER: C95965 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 421.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:04 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0569 2.1026 4.2312 24.8958 .5544 3.5478 .2759 .0214 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0135 % .4984 % 1.0029 % 5.9009 % .1314 % .8409 .0654 % .0051 % ORGAN TO BRAIN WEIGHT RATIO .0271 1.0000 2.0124 11.8405 .2637 1.6873 .1312 .0102 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LIVER (LI) : -LARGE; ALL LOBES: THICKENED -DIFFUSELY DARK; ALL LOBES: DARK BROWN GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL KIDNEY (KD) : -MINERALIZATION, TUBULAR,-MINIMAL HEART (HT) : -DEGENERATION/NECROSIS,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT JEJUNUM (JE) : UNREMARKABLE NOTE:>ON SLIDE 13. 004938 391 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 102 ANIMAL NUMBER: C95965 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 421.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:04 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) i 004939 I 392 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 103 ANIMAL NUMBER: C95966 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 444.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:53 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0524 2.0426 4.8321 20.9821 .7381 3.0674 .3532 .0227 .0118 % .4597 % 1.0876 % 4.7225 % .1661 % .6904 % .0795 % .0051 % .0257 1.0000 2.3657 10.2723 .3614 1.5017 .1729 .0111 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL LN, MESENTERIC (MS) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 004940 i 393 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3H T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 104 ANIMAL NUMBER: C95966 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 444.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:53 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY),BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY),BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC(SN), SPLEEN (SP), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 'i >P* 394 t t 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 105 ANIMAL NUMBER: C95967 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 447.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:54 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0473 2.1398 4.1495 25.0600 .4205 3.2710 .1537 .0278 .0106 % .4778 % .9266 % 5.5962 % .0939 % .7305 % .0343 % .0062 .0221 1.0000 1.9392 11.7114 .1965 1.5286 .0718 .0130 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 THYMUS (TH) : -DIFFUSELY RED; RIGHT LOBE LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL -VACUOLATION, HEPATOCELLULAR, DIFFUSE,-SLIGHT >NOTE:>PIGMENT IS CONCENTRATED IN THE CYTOPLASM OF CENTRILOBULAR HEPATOCYTES NEAR BILE CANALICULI. KIDNEY (KD) : -DILATATION, PELVIC,-SLIGHT THYMUS (TH) : -HEMORRHAGE,-MINIMAL -INVOLUTION,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PITUITARY (PI) : -CYST,-PRESENT 004942 395 t APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.I 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 106 ANIMAL NUMBER: C95967 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/96 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 447.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:54 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER NECROPSY O B S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) (SV), THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC),TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), STOMACH, GL (ST),STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), URINARYBLADDER <UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 004943 t 396 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 107 ANIMAL NUMBER: C95968 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 459.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:58 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0730 2.1136 4.2887 24.0192 .9478 2.8087 .2901 .0236 .0159 % .4600 % .9333 % 5.2272 % .2063 % .6113 % .0631 % .0051 % .0345 1.0000 2.0291 11.3641 .4484 1.3289 .1373 .0112 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL ADRENAL, CORTEX (AC) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT ' 004944 i 397 ( 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 108 ANIMAL NUMBER: C95968 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 459.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:58 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM),NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH),LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) , CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) :i 004945 398 | 'l APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 109 ANIMAL NUMBER: C95969 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 465.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:41 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0691 2.0668 5.0360 22.5076 .7573 3.3886 .2489 .0252 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0148 .4437 % 1.0812 % 4.8320 % .1626 % .7275 % .0534 % .0054 % ORGAN TO BRAIN WEIGHT RATIO .0334 1.0000 2.4366 10.8901 .3664 1.6395 .1204 .0122 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY KIDNEY (KD) : -LARGE PELVIS(ES); RIGHT STOMACH, GL (ST) : -DARK FOCUS(I)/AREA(S); MUCOSA: MULTIPLE DARK BROWN AREAS, UP TO 2 X 1 MM LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL KIDNEY (KD) : -DILATATION, PELVIC,-MODERATE HEART (HT) : -DEGENERATION/NECROSIS,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL STOMACH, GL (ST) : -EROSION,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 004946 399 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 110 ANIMAL NUMBER: C95969 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 465.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:41 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER NECROPSY O B S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN PROSTATE (PR) : -INFLAMMATION, CHRONIC-ACTIVE,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) (PR), THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 004947 I 400 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3H T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 111 A N IM A L NUM BER: C95970 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E OF D E A T H : 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 439.7 GRAMS D A T E A N D TIME OF NECROPSY: 12/02/98 8:47 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN ADESTINE P O S T - F I X WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO O RGA N STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0560 2.2490 3.7296 23.2250 .6436 3.5189 .2718 .0230 .0127 % .5115 % .8482 % 5.2820 % .1464 % .8003 % .0618 % .0052 % .0249 1.0000 1.6583 10.3268 .2862 1.5647 .1209 .0102 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 LN, MANDIBULAR <MN) : -MOTTLED,- BILATERAL: DARK RED AND TAN GENERAL COMMENT {GO : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL UPPER INCISORS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, COAGULATIVE,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL PANCREAS (PA) : -INFLAMMATION, CHRONIC-ACTIVE,-MINIMAL -PIGMENT, BROWN,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL | C. |i J 004948 t 401 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 112 ANIMAL NUMBER: C95970 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 439.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:47 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) 004949 402 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3H T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 113 ANIMAL NUMBER: C95971 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 309.1 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:57 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 14.5443 ----------------------------- ---------------------- 4.7054 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU ), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ! , P !' i 004950 I 403 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS PAGE: 114 ANIMAL NUMBER: C95972 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 333.3 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 12:06 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 14.9723 ----------------------------- ---------------------- 4.4921 % ----------------------------- ---------------....... ------------------------------------ NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) 004951 404 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 115 ANIMAL NUMBER: C95973 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 276.7 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:48 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 13.1995 ------------:----------------- ---------------------- 4.7703 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE) , ILEUM (IL) . CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDER IAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) < f 004952 405 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 116 ANIMAL NUMBER: C95974 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 311.4 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:22 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 14.4142 ----------------------------- ---------------------- 4.6288 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDER IAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) 004953 406 i 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 117 ANIMAL NUMBER: C95975 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 327.4 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:53 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) 16.4042 5.0104 % NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) 004954 407 i ! f, APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 118 ANIMAL NUMBER: C95976 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 382.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:23 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0447 2.1994 3.5516 21.3634 .4872 3.4775 .2380 .0300 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0117 % .5746 % .9278 % 5.5808 % .1273 % .9084 % .0622 % .0078 % ORGAN TO BRAIN WEIGHT RATIO .0203 1.0000 1.6148 9.7133 .2215 1.5811 .1082 .0136 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,- MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT 004955 ( 408 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 119 ANIMAL NUMBER: C95976 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 382.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:23 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM) ,MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP) , THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) i 004956 409 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 120 ANIMAL NUMBER: C95977 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 454.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:58 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0587 2.0929 4.2673 25.0541 .7871 3.4440 .2202 .0339 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0129 % .4604 % .9387 5.5112 % .1731 % .7576 % .0484 % .0075 % ORGAN TO BRAIN WEIGHT RATIO .0280 1.0000 2.0389 11.9710 .3761 1.6456 .1052 .0162 O RGA N STATUS 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 THYMUS (TH) : -RED FOCUS(I)/AREA(S); BOTH LOBES: MULTIPLE DARK RED, PINPOINT FOCI LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -VACUOLATION, HEPATOCELLULAR, DIFFUSE,-SLIGHT HEART (HT) : -DEGENERATION/NECROSIS,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL ' * it 004957 410 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 121 ANIMAL NUMBER: C95977 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 454.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:58 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT N ECR O PSY : BONE, FEMUR ( F E ) , MARROW, FEMUR ( F M ) , MARROW, STERNUM ( S E ) , B O N E , STERNUM ( S B ) , EYE ( E Y ) , B R A I N (B R ) , SPIN A L CORD ( S C ) , LUNG ( L U ) , TRACHEA ( T R ) , ESOPHAGUS ( E S ) , L IV E R ( L I ) , KIDNEY ( K D ) , HEART ( H T ) , M USCLE, SKELETAL ( S M ) , NERVE, S C IA T IC ( S N ) , SPLEEN ( S P ) , LN, MESENTERIC (M S ), THYROID ( T Y ) , PARATHYROID ( P T ) , ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (M A ), AORTA (A O ), P IT U IT A R Y ( P I ) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , PANCREAS ( P A ) , DUODENUM ( D U ) , JEJU NU M ( J E ) , ILEUM ( I L ) , CECUM ( C E ) , COLON ( C O ) , RECTUM ( R E ) , S A L I V G L , M ANDIB (S G ) , HARDERIAN GLAND (H G ), AUDITORY SEB GL ( A S ) , SK IN ( S K ) , URINARY BLADDER ( U B ) , PROSTATE ( P R ) , SEMINAL V E SIC L E S ( S V ) , T E ST IS ( T E ) , EPIDIDYM IDES ( E P ) , TA IL (T I) THE FOLLOWING T I S S U E S WERE UNREMARKABLE AT M IC R O SC O P IC E X A M IN A T IO N : BONE, FEMUR ( F E ) , MARROW, FEMUR ( F M ) , MARROW, STERNUM ( S E ) , BO N E, STERNUM ( S B ) , EYE ( E Y ) , B R A IN ( B R ) , SPIN A L CORD (S C ), TRACHEA (T R ), ESOPHAGUS ( E S ) , KIDNEY (K D ), MUSCLE, SKELETAL (S M ), NERVE, SC IA T IC ( S N ) , SPL E E N ( S P ) , LN, M E SE N T E R IC ( M S ) , TH Y R O ID ( T Y ) , PARATH YROID ( P T ) , A DR EN AL, CORTEX ( A C ) , ADR EN AL, MEDULLA (MA) , AORTA (A O ), P IT U IT A R Y ( P I ) , STOMACH, GL ( S T ) , STOMACH, NONGL (S U ) , PANCREAS ( P A ) , DUODENUM ( D U ) , JEJUNUM ( J E ) , ILEUM ( I L ) , CECUM (C E ) , COLON ( C O ) , RECTUM ( R E ) , S A L I V G L , M ANDIB (S G ) , H A RDERIAN GLAND (HG) , A U D ITO R Y S E B GL ( A S ) , SK IN (S K ) , URINARY BLADDER ( U B ), PROSTATE (P R ), SEMINAL V E SIC L E S ( S V ) , T E S T IS ( T E ) , EPID ID Y M IDES (EP) ' 4 004958 411 I I f | APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 122 ANIMAL NUMBER: C95978 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 454.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:40 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0568 2.1377 3.6874 28.4115 .6243 3.8868 .1836 .0245 .0125 % .4707 % .8118 % 6.2553 % .1375 % .8557 % .0404 % .0054 t .0266 1.0000 1.7249 13.2907 .2920 1.8182 .0859 .0115 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LIVER (LI) : -LIGHT FOCUS(I)/AREA(S); DIAPHRAGMATIC SURFACE OF LEFT LATERAL LOBE: MULTIPLE TAN AREAS, PINPOINT AND UP TO 1 MM IN DIAMETER; COLLECTED ON ROUTINE SECTION GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, COAGULATIVE,-SLIGHT -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL SLIGHT THYMUS (TH) I -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL < 4 004359 412 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOKOOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 123 ANIMAL NUMBER: C95978 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 454.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:40 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) , TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE. FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) it 00496 413 I ?'i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 124 ANIMAL NUMBER: C95979 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 435.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:16 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0499 2.2608 3.8911 23.2324 .6649 3.4924 .2278 .0253 .0115 % .5197 % .8945 % 5.3408 % .1529 % .8029 % .0524 % .0058 % .0221 1.0000 1.7211 10.2762 .2941 1.5448 .1008 .0112 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR,CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE, -SLIGHT THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT j i I J 004961 I 414 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 125 ANIMAL NUMBER: C95979 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D ATE OF D E A T H : 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 435.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:16 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE) , EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES TESTIS (TE), EPIDIDYMIDES (EP) (SV), 004962 i 415 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 126 ANIMAL NUMBER: C95980 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 434.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:24 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0539 2.2717 4.2176 24.1794 .6736 3.5469 .2741 .0237 .0124 % .5234 % .9718 % 5.5713 % .1552 % .8173 % .0632 % .0055 % .0237 1.0000 1.8566 10.6437 .2965 1.5613 .1207 .0104 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE, -MINIMAL AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT 004963 416 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 127 ANIMAL NUMBER: C95980 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 434.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:24 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK>, URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) i $$6^00 417 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 128 ANIMAL NUMBER: C95981 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 296.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:39 PROSECTOR: JOHN S, HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0884 1.9910 2.5928 11.3754 .0971 .9631 .2919 .0246 .0298 t .6713 % .8742 % 3.8353 % .0327 % .3247 % .0984 % .0083 % .0444 1.0000 1.3023 5.7134 .0488 .4837 .1466 .0124 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY SPLEEN (SP) : -ADHESION(S); ENTIRE SPLEEN ADHERED TO PANCREAS AND SURROUNDING ADIPOSE TISSUE: MULTIPLE GRAY AND TAN FIBROUS ADHESIONS; COLLECTED INTACT PITUITARY (PI) : -LARGE; 6 X 5 X 3 MM; APPEARS SWOLLEN LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL SPLEEN (SP) : -INFLAMMATION, CHRONIC, CAPSULAR,-MODERATE >NOTE:>THERE ARE NUMEROUS PIGMENT-CONTAINING MACROPHAGES IN THE AREAS OF CHRONIC INFLAMMATION. THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PITUITARY (PI) : -HYPERPLASIA,-MODERATE PANCREAS (PA) : -ATROPHY, ACINAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL RECTUM (RE) : -PARASITISM,-PRESENT LN, MANDIBULAR (MN) : -HYPERPLASIA, PLASMACYTIC,-MODERATE 004965 ! 418 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 129 ANIMAL NUMBER: C95981 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/90 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 296.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:39 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER NECROPSY O B S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL NERVE, SCIATIC (SN), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID <PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS <UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) (SM), THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 004966 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 130 ANIMAL NUMBER: C95982 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 251.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:38 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0501 1.7308 1.8839 7.3455 .1041 .4764 .3310 .0135 .0199 % .6887 % .7497 % 2.9230 % .0414 % .1896 % .1317 % .0054 % .0289 1.0000 1.0885 4.2440 .0601 .2752 .1912 .0078 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 96^00 420 ! 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 131 ANIMAL NUMBER: C95982 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 251.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:38 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV) , VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 004968 I 421 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 132 ANIMAL NUMBER: C95983 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT 223.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:35 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0677 1.8357 2.1211 7.7858 .1169 .4244 .2297 .0160 .0303 % .8206 % .9482 % 3.4805 % .0523 % .1897 % .1027 % .0072 % .0369 1.0000 1.1555 4.2413 .0637 .2312 .1251 .0087 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0 B SERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -FIBROSIS, CAPSULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION,, HEPATOCELLULAR, PERIPORTAL,-MINIMAL THYMUS (TH) : -HEMORRHAGE,--MINIMAL -INVOLUTION, --MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT 004369 422 ( APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 133 ANIMAL NUMBER: C95983 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 223.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:35 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR <FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV) , VAGINA (VA) 004 CD >1 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 134 ANIMAL NUMBER: C95984 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 266.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:26 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0689 2.1061 2.2832 8.6507 .1184 .5182 .2544 .0185 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0258 .7894 % .8558 % 3.2424 % .0444 % .1942 % .0954 % .0069 % ORGAN TO BRAIN WEIGHT RATIO .0327 1.0000 1.0841 4.1074 .0562 .2460 .1208 .0088 ORGAN STATUS 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; GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BILATERAL: CLEAR FLUID THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT UTERUS (UT) : >UNREMARKABLE ^ 6>00 ! 424 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 135 ANIMAL NUMBER: C95984 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 266.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:26 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW. FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA) f i Zitefroo l 425 f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 136 ANIMAL NUMBER: C95985 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 283.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:20 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST : JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH> THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0785 2.0288 2.1159 8.9903 .1524 .5420 .2466 .0227 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0277 % .7169 % .7477 % 3.1768 % .0539 % .1915 % .0871 % .0080 % ORGAN TO BRAIN WEIGHT RATIO .0387 1.0000 1.0429 4.4313 .0751 .2672 .1215 .0112 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT 004973 1 426 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 137 ANIMAL NUMBER: C95985 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 283.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:20 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) , CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT), CERVIX (CV) , OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) i 004974 j 427 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 138 ANIMAL NUMBER: C95986 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 264.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:34 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0824 1.9890 2.1350 7.8859 .1421 .5597 .3403 .0156 .0312 % .7526 % .8078 % 2.9837 % .0538 % .2118 % .1288 % .0059 % .0414 1.0000 1.0734 3.9648 .0714 .2814 .1711 .0078 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 004975 428 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 139 ANIMAL NUMBER: C95986 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 264.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:34 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM),MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB) , UTERUS (UT). CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM) ,MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 9.CtOQ 429 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 140 ANIMAL NUMBER: C95987 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 244.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:51 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0980 1.8897 1.9180 7.2576 .1316 .4780 .3293 .0233 .0401 % .7741 % .7857 % 2.9732 % .0539 % .1958 % .1349 % .0095 % .0519 1.0000 1.0150 3.B4D6 .0696 .2530 .1743 .0123 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYROID (TY) : -CYST. ULTIMOBRANCHIAL,-PRESENT LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL UTERUS (UT) : -DILATATION,-MINIMAL { t f i 004977 430 ! I`i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 141 ANIMAL NUMBER: C95987 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 244.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:51 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE. FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC),LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL(SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SAL1V GL, MAND1B (SG) , HARDER1 AN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC).TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM),NERVE, SCIATIC(SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA) i 43 i I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 142 ANIMAL NUMBER: C95988 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 252.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:22 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0716 1.8513 1.8853 7.0591 .1193 .4753 .3660 .0136 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0283 .7329 % .7464 % 2.7946 % .0472 % .1882 % .1449 % .0054 % ORGAN TO BRAIN WEIGHT RATIO .0387 1.0000 1.0184 3.8131 .0644 .2567 .1977 .0073 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL KIDNEY (KD) : -MINERALIZATION, TUBULAR,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT 004379 432 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 143 ANIMAL NUMBER: C95988 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 252.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:22 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT N E C R O PSY : BO N E . FEMUR ( F E ) , MARROW, FEMUR ( F M ) , MARROW, STERNUM ( S E ) , B O N E , STERNUM ( S B ) , EY E ( E Y ) , B R A I N ( B R ) , S P IN A L CORD ( S C ) , LUNG ( L U ) , TRACHEA ( T R ) , ESOPHAGUS (E S ) , L IV E R ( L I ) , KIDNEY ( K D ) , HEART ( H T ) , MUSCLE, SKELETAL ( S M ) , NERVE, S C IA T IC ( S N ) , SPLEEN ( S P ) , THYMUS ( T H ) , LN, MESENTERIC (M S ), THYROID ( T Y ) , PARATHYROID ( P T ) , ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (M A ), AORTA (A O ), P IT U IT A R Y ( P I ) , STOMACH, GL ( S T ) , STOMACH, NONGL (S U ) , PANCREAS ( P A ) , DUODENUM ( D U ) , JEJU NU M ( J E ) , ILEUM ( I L ) , CECUM ( C E ) , COLON ( C O ) , RECTUM ( R E ) , LN, MANDIBULAR (MN) , S A L I V G L , M ANDIB (S G ) , H A R D E R IA N GLAND (H G ) , A U D IT O R Y S E B GL ( A S ) , S K I N ( S K ) , MAMMARY, FEM ALE (M F) , URINARY BLADDER ( U B ) , UTERUS ( U T ) , C ERV IX ( C V ) , OVARY ( O V ) , VAGINA ( V A ) , T A IL ( T I ) THE FOLLOWING T I S S U E S WERE UNREMARKABLE AT M IC R O SC O P IC EX A M IN A T IO N : BO N E , FEMUR ( F E ) , MARROW, FEMUR ( F M ) , MARROW, STERNUM ( S E ) , B O N E , STERNUM ( S B ) , E Y E ( E Y ) , B R A IN (B R ) , S P IN A L CORD ( S C ) , LUNG ( L U ) , TRACHEA ( T R ) , ESOPHAGUS ( E S ) , HEART ( H T ) , MUSCLE, SKELETAL ( S M ) , N ERVE, S C IA T IC ( S N ) , SPLEEN ( S P ) , LN, MESENTERIC (M S ), PARATHYROID ( P T ) , ADRENAL, CORTEX (A C ), ADRENAL, MEDULLA (M A ), AORTA (A O ), P IT U IT A R Y ( P I ) , STOMACH, GL ( S T ) , STOMACH, NONGL ( S U ) , PANCREAS ( P A ) , DUODENUM ( D U ) , JEJU NU M ( J E ) , ILEUM ( I L ) , CECUM ( C E ) , COLON (C O ), RECTUM ( R E ) , LN, MANDIBULAR (M N ), S A L IV G L, MANDIB ( S G ) , HARDERIAN GLAND (HG) , A U D IT O R Y S E B GL ( A S ) , S K I N (S K ) , MAMMARY, FEMALE ( M F ) , U R IN A R Y B LA DD ER ( U B ) , U T E R U S ( U T ) , C E R V IX ( C V ) , OVARY ( O V ) , VAGINA (VA) 4 004980 433 ! APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 144 ANIMAL NUMBER: C95989 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 277.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:40 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0673 1.9052 1.9871 7.3952 .1033 .5285 .2674 .0121 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0243 % .6878 % .7174 % 2.6697 % .0373 % .1908 % .0965 % .0044 % ORGAN TO BRAIN WEIGHT RATIO .0353 1.0000 1.0430 3.8816 .0542 .2774 .1404 .0064 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT 004981 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 145 ANIMAL NUMBER: C95989 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 277.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:40 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE(EY),BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART(HT), MUSCLE, SKELETAL(SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH,. GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE(EY),BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM), NERVE, SCIATIC(SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA) 435 I`l APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 146 ANIMAL NUMBER: C95990 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 313.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:30 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0642 1.8999 2.3886 8.8486 .1396 .4933 .2034 .0280 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0205 % .6070 % .7631 % 2.8270 % .0446 % .1576 % .0650 % .0089 % ORGAN TO BRAIN WEIGHT RATIO .0338 1.0000 1.2572 4.6574 .0735 .2596 .1071 .0147 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL > 436 i ,4 I i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 147 ANIMAL NUMBER: C95990 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 313.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:30 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) ,MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO),PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE),ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) NERVE, SCIATIC(SN), 0049S4 437 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 148 ANIMAL NUMBER: C95991 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 205.1 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:32 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 6.8351 ----------------------------- ---------------------- 3.3326 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 004985 438 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 149 ANIMAL NUMBER: C95992 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 180.6 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:51 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 5.8602 ----------------------------- ---------------------- 3.2449 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) >I j |. 4 0043S6 439 I i i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 150 ANIMAL NUMBER: C95993 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 201.3 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:38 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 6.0180 ----------------------------- ---------------------- 2.9896 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) t I ! i 004987 I 440 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 151 ANIMAL NUMBER: C95994 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 215.5 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:25 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------- T---- 7.0305 ----------------------------- ---------------------- 3.2624 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) j ' [' 4 004988 i 441 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS PAGE: 152 ANIMAL NUMBER: C95995 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 188.5 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 12:01 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 5.7678 ----------------------------- ---------------------- 3.0598 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) < 004989 442 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 153 ANIMAL NUMBER: C95996 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 268.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:35 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST : JOHN EIGHMY 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) .0538 2.0029 2.2491 7.19 49 .1609 .4536 .2401 .0251 .0200 % .7448 % .8364 % 2.6682 % .0598 % .1687 % .0893 % .0093 % .0269 1.0000 1.1229 3.5822 .0803 .2265 .1199 .0125 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL 004990 443 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 154 ANIMAL NUMBER: C95996 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 268.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:35 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 004991 444 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 155 ANIMAL NUMBER: C95997 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 247.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:02 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0693 1.8393 2.0840 6.8198 .1272 .4192 .2108 .0177 .0280 % .7429 % .8417 % 2.7544 % .0514 % .1693 % .0851 % .0071 % .0377 1.0000 1.1330 3.7078 .0692 .2279 .1146 .0096 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS THYMUS (TH) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT 004992 445 ! APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 156 ANIMAL NUMBER: C95997 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 247.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:02 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN. MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV) , VAGINA (VA) 'i C6G-00 446 i jf APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 157 ANIMAL NUMBER: C95998 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 240.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:40 PROSECTOR: KIMBERLY DURLAND RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0641 2.0289 1.8478 6.0936 .1647 .4325 .3476 .0341 .0267 % .8447 % .7693 % 2.5369 % .0686 % .1801 % .1447 % .0142 % .0316 1.0000 .9107 3.0034 .0812 .2132 .1713 .0168 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT 004994 I 447 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 158 ANIMAL NUMBER: C95998 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 240.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:40 PROSECTOR: KIMBERLY DURLAND RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL. MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) ,MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , SKIN (SK) , MAMMARY, FEMALE (MF) ,URINARY BLADDER (UB) ,UTERUS (UT) , CERVIX (CV), OVARY (OV), VAGINA (VA) , {I 4 004995 i 448 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 159 ANIMAL NUMBER: C95999 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 358.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:25 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .07 52 2.0931 2.4475 9.9107 .1232 .5403 .3750 .0228 .0210 % .5840 % .6829 % 2.7653 % .0344 % .1508 % .1046 % .0064 % .0359 1.0000 1.1693 4.7349 .0589 .2581 .1792 .0109 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 160 ANIMAL NUMBER: C95999 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 358.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:25 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN. MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) t 1 i 004397 I 450 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 161 ANIMAL NUMBER: C96000 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 269.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:11 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0647 1.9596 1.9224 8.1750 .1191 .4243 .1879 .0169 .0240 % .7266 % .7128 % 3.0311 % .0442 .1573 % .0697 % .0063 % .0330 1.0000 .9810 4.1718 .0608 .2165 .0959 .0086 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE,LYMPHOHISTIOCYTIC,-MINIMAL AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT j * I1 i 004398 I 451 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 162 ANIMAL NUMBER: C96000 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 269.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:11 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP) , THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 4 660^09 452 \'i APPENDIX 6 Individuai Anatomie Pathology Data Covance 6329-225 3M T-6314.I 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 163 ANIMAL NUMBER: C96001 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 233.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:11 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0574 1.8284 2.1472 7.2356 .1433 .5303 .3077 .0305 .0246 % .7834 % .9200 % 3.1001 % .0614 % .2272 % .1318 % .0131 % .0314 1.0000 1.1744 3.9573 .0784 .2900 .1683 .0167 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: -- BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), 1 SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), O NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL. MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) oc e 453 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 164 ANIMAL NUMBER: C96002 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 228.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:25 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0630 2.0244 1.9083 7.1598 .1099 .4890 .2793 .0179 .0276 % .8863 % .8355 % 3.1348 % .0481 % .2141 % .1223 % .0078 % .0311 1.0000 .9426 3.5368 .0543 .2416 .1380 .0088 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; GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BILATERAL; CLEAR FLUID LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL UTERUS (UT) : -DILATATION,-SLIGHT THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP) , THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) I j 4 005001 454 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 165 ANIMAL NUMBER: C96003 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT': 217..5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10: 50 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0598 1.9851 1.7313 6.5350 .1142 .5506 .2760 .0194 .0275 % .9127 % .7960 % 3.0046 % .0525 % .2531 t .1269 % .0089 % .0301 1.0000 .8721 3.2920 .0575 .2774 .1390 .0098 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0 B S E R V A T I C )N S HISTOPATHOLOGY UTERUS (UT) : -LUMEN FILLED WITH FLUID; GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BILATERAL: CLEAR FLUID UTERUS (UT) : -DILATATION, -MODERATE 005002 I 455 APPENDIX 6 Individual Anatomic Pathology Data Covanee 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 166 ANIMAL NUMBER: C96003 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 217.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:50 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) ! j' * 005003 ! 456 APPENDIX 6 Individuai Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 167 ANIMAL NUMBER: C96004 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 263.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:34 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0516 1.9505 2.2579 8.3001 .1230 .5005 .2900 .0143 .0196 % .7399 % .8566 % 3.1487 % .0467 % .1899 % .1100 % .0054 % .0265 1.0000 1.1576 4.2554 .0631 .2566 .1487 .0073 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS COSO04 457 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 168 ANIMAL NUMBER: C96004 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 263.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:34 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) 4 O n o 0 01 I 458 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 169 ANIMAL NUMBER: C96005 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 243.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:05 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0702 1.8993 2.2248 8.2448 .1103 .4497 .3365 .0162 .0288 % .7794 % .9129 % 3.3832 % .0453 % .1845 % .1381 % .0066 % .0370 1.0000 1.1714 4.3410 .0581 .2368 .1772 .0085 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) C0S006 I 459 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 170 ANIMAL NUMBER: C96006 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 249.2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:36 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0512 1.9754 1.8567 7.3435 .1079 .4943 .2233 .0032 .0205 % .7927 % .7451 % 2.9468 % .0433 % .1984 % .0896 % .0013 % .0259 1.0000 .9399 3.7175 .0546 .2502 .1130 .0016 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) 005007 i 460 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 171 ANIMAL NUMBER: C96007 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 252.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:06 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0765 2.0179 2.2417 8.5804 .1210 .6280 .3639 .0251 .0303 % .7992 % .8878 % 3.3982 % .0479 % .2487 % .1441 % .0099 % .0379 1.0000 1.1109 4.2521 .0600 .3112 .1803 .0124 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL <SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) 005008 461 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 172 ANIMAL NUMBER: C96008 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 277.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:19 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0821 1.9908 2.4080 9.2167 .1217 .6382 .3024 .0224 .0296 % .7171 % .8674 % 3.3201 % .0438 % .2299 % .1089 % .0081 % .0412 1.0000 1.2096 4.6296 .0611 .3206 .1519 .0113 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS GENERAL INFORMATION (XX) : >NOTE:>ANIMAL IDENTIFICATION TRANSPONDER DAMAGED AT NECROPSY LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) 005009 I 462 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 173 ANIMAL NUMBER: C96009 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 208.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:20 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0564 1.9241 1.8706 5.9471 .1006 .4206 .1966 .0090 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0270 % .9219 % .8963 % 2.8496 % .0482 % .2015 % .0942 % .0043 % ORGAN TO BRAIN WEIGHT RATIO .0293 1.0000 .9722 3.0908 .0523 .2186 .1022 .0047 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 4 O o ccn h* O 4 463 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 174 ANIMAL NUMBER: C96009 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 208.7 GRAMS D A T E AND TIME OF NECROPSY: 12/02/98 8:20 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR <FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) f 1 005011 464 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 175 ANIMAL NUMBER: C96010 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 263.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:35 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0658 2.0743 2.0370 8.2431 .0965 .5876 .3850 .0181 .0250 % .7887 % .7745 % 3.1343 % .0367 % .2234 .1464 % .0069 % .0317 1.0000 .9820 3.9739 .0465 .2833 .1856 .0087 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) j ' ], ! j 005012 465 t APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3m T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 176 ANIMAL NUMBER: C96011 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 226.8 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 12:09 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) -------- --------------- 7.5294 ----------------------------- -------- --------------- 3.3198 % ----------------------------- -------- -------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) T0 -?0 9 466 ( APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 177 ANIMAL NUMBER: C96012 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 191.9 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:05 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) -----------.----------- 6.5011 ----------------------------- ---------------------- 3.3878 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 178 ANIMAL NUMBER: C96013 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 223.1 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:31 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 7.7373 ----------------------------- ---------------------- 3.4681 % ----------------------- ------ --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 005015 i 468 \ APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 179 ANIMAL NUMBER: C96014 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 227.7 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:07 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) 7.4920 3.2903 % NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 005016 469 j APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 180 ANIMAL NUMBER: C96015 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OP DEATH: 5 TERMINAL BODY WEIGHT: 210.4 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:14 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 7.0360 ----------------------------- ---------------------- 3.3441 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE! 181 ANIMAL NUMBER: C96016 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: UNSCHEDULED (M) DATE OF DEATH: 10/29/98 STUDY DAY OF DEATH: 59 STUDY WEEK OF DEATH: 9 TERMINAL BODY WEIGHT: 272.9 GRAMS DATE AND TIME OF NECROPSY: 10/29/98 15:09 PROSECTOR: JAMES T. CALLEN RECORDER: JAMES T. CALLEN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: JAMES T. CALLEN *** ORGAN WEIGHTS WERE NOT RECORDED *** NECROPSY OBSERVATIONS HISTOPATHOLOGY TAIL (TI) : -LACERATION(S); 20 MM FROM BASE OF TAIL: SINGLE LACERATION, 20 X 10 MM; SURROUNDING TISSUE APPEARS SWOLLEN AND EXUDES A DARK RED SEMIFLUID; COLLECTED LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL TAIL (TI) : -HEMORRHAGE,-SLIGHT -ULCERATION,-MINIMAL 005018 471 ! APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 182 ANIMAL NUMBER: C96016 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: UNSCHEDULED (M) DATE OF DEATH: 10/29/98 STUDY DAY OF DEATH: 59 STUDY WEEK OF DEATH: 9 TERMINAL BODY WEIGHT: 272.9 GRAMS DATE AND TIME OF NECROPSY: 10/29/98 15:09 PROSECTOR: JAMES T. CALLEN RECORDER: JAMES T. CALLEN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: JAMES T. CALLEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), GENERAL COMMENT (GC) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) ( 6T0S09 472 I 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 183 ANIMAL NUMBER: C96017 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 277.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:41 PROSECTOR: JODI THIEREN RECORDER; STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0693 2.0282 2.2400 8.0588 .1886 .5476 .3084 .0200 .0250 % .7311 % .8075 % 2.9051 % .0680 .1974 % .1112 % .0072 % .0342 1.0000 1.1044 3.9734 .0930 .2700 .1521 .0099 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL UPPER INCISORS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE <MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) O f coso; 473 I i 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 184 ANIMAL NUMBER: C96018 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH; 14 TERMINAL BODY WEIGHT : 279..7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:50 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0805 1.9028 2.0616 8.0095 .1174 .5094 .2793 .0175 .0288 % .6803 % .7371 % 2.8636 % .0420 % .1821 % .0999 % .0063 % .0423 1.0000 1.0835 4.2093 .0617 .2677 .1468 .0092 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0B SERVATIONS HISTOPATHOLOGY THYMUS (TH) : -DIFFUSELY RED; DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE ,-MINIMAL THYMUS (TH) : -HEMORRHAGE, -SLIGHT -INVOLUTION, -MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL NERVE, SCIATIC (SN). SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) (SM), 005021 474 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 185 ANIMAL NUMBER: C96019 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT': 283..2 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12: 12 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0860 2.0462 2.6887 8.9464 .1290 .5329 .3098 .0209 .0304 % .7225 % .9494 % 3.1590 % .0456 % .1882 % .1094 % .0074 % .0420 1.0000 1.3140 4.3722 .0630 .2604 .1514 .0102 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0 B S E R V A T I C )N S HISTOPATHOLOGY UTERUS (UT) : -LUMEN FILLED WITH FLUID; GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BILATERAL: CLEAR FLUID UTERUS (UT) : -DILATATION, -SLIGHT 00502 0 475 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 186 A N IM A L N UM BER: C96019 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E O F D E A T H : 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 283.2 GRAMS D A T E A ND TIME OF NECROPSY: 12/02/98 12:12 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS P O S T - F I X WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) C20S00 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 187 ANIMAL NUMBER: C96020 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 239.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:06 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0746 1.9018 2.0893 8.3210 .1320 .4508 .2735 .0172 .0311 % .7927 % .8709 % 3.4685 % .0550 % .1879 % .1140 % .0072 % .0392 1.0000 1.0986 4.3753 .0694 .2370 .1438 .0090 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD) , HEART (HT), MUSCLE, SKELETAL (SM), NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID <PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) 005024 477 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 188 ANIMAL NUMBER: C96021 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT : 239 .7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:36 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0599 1.9833 2.1418 7.9743 .1125 .5182 .2110 .0159 .0250 % .8274 .8935 % 3.3268 % .0469 % .2162 % .0880 % .0066 % .0302 1.0000 1.0799 4.0207 .0567 .2613 .1064 .0080 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY O B SERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE ,-MINIMAL 005025 478 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3H T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 189 ANIMAL NUMBER: C96021 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 239.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:36 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) COS026 479 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 190 ANIMAL NUMBER: C96022 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 264.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:09 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0765 2.0837 2.1627 8.7642 .1119 .5033 .2463 .0279 .0289 .7881 % .8180 % 3.3147 % .0423 % .1904 % .0932 % .0106 % .0367 1.0000 1.0379 4.2061 .0537 .2415 .1182 .0134 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR,CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL Cj C;1 rOo i ( * ! 4 480 I i f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 191 ANIMAL NUMBER: C96022 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 264.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:09 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) I r* \ Ci o N GO 481 ( APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 192 ANIMAL NUMBER: C96023 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 253.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:06 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0695 2.0599 2.5238 10.5886 .1184 .5279 .3996 .0150 .0275 % .8142 % .9975 % 4.1852 % .0468 % .2087 % .1579 % .0059 % .0337 1.0000 1.2252 5.1403 .0575 .2563 .1940 .0073 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL , 4 620S00 482 ii APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 193 A N IM A L N U M B E R : C96023 SE X : FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E OF D E A T H : 12/02/98 S T U D Y D A Y OF D E A T HI:: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 253.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:06 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 483 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 194 ANIMAL NUMBER: C96024 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 257.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:12 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0753 2.1505 2.5361 8.6565 .1361 .4379 .2907 .0183 .0292 % .8345 % .9841 % 3.3591 % .0528 % .1699 % .1128 % .0071 % .0350 1.0000 1.1793 4.0253 .0633 .2036 .1352 .0085 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 005031 484 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 195 ANIMAL NUMBER: C96024 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 257.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:12 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR <FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) I J, 4 60503 N 485 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 196 ANIMAL NUMBER: C96025 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 253.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:33 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0788 1.9934 2.3465 9.8976 .1407 .5995 .2171 .0268 .0310 % .7851 % .9242 % 3.8982 % .0554 % .2361 % .0855 % .0106 % .0395 1.0000 1.1771 4.9652 .0706 .3007 .1089 .0134 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0 BSERVATIONS ' HISTOPATHOLOGY STOMACH, GL (ST) : -LIGHT FOCUS(I)/AREA(S); MUCOSA, NEAR ESOPHAGEAL GROOVE : SINGLE WHITE PINPOINT SLIGHTLY RAISED FOCUS LN, MANDIBULAR (MN) : -MOTTLED; BILATERAL: RED AND TAN OVARY (OV) : -DIFFUSELY RED; BILATERAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL STOMACH, GL (ST) ; >UNREMARKABLE >NOTE:>THERE IS A FOCAL AREA OF NORMAL- APPEARING SKELETAL MUSCLE IN THE TUNICA MUSCULARIS IN THE REGION OF THE LIMITING RIDGE. LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL OVARY (OV) : UNREMARKABLE c V b033 486 APPENDIX 6 Individual Anatomic Pathology Data Covance G329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 197 ANIMAL NUMBER: C96025 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 253.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:33 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, NONGL (SU) APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 198 ANIMAL NUMBER: C96026 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 232.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:08 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0700 1.9824 2.0111 8.3034 .1165 .4610 .2781 .0139 .0301 % .8526 % .8650 % 3.5714 % .0501 % .1983 % .1196 % .0060 % .0353 1.0000 1.0145 4.1886 .0588 .2325 .1403 .0070 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT <GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR,CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL r-> O '", f ,*? U! j 1 4 SCC 488 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 199 ANIMAL NUMBER: C96026 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH:I: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 232.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:08 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 036 489 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 200 ANIMAL NUMBER: C96027 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 296.8 GRAMS D A T E AND TIME OF NECROPSY: 12/02/98 10:10 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0659 1.9373 2.3111 9.8850 .1046 .5319 .3779 .0177 .0222 % .6527 % .7787 % 3.3305 % .0352 % .1792 % .1273 % .0060 % .0340 1.0000 1.1929 5.1025 .0540 .2746 .1951 .0091 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL 005037 490 j : f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 201 ANIMAL NUMBER: C96027 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH:I: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 296.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:10 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 491 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 202 ANIMAL NUMBER: C96028 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 259.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:00 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0628 1.9952 2.0909 8.7646 .1106 .5702 .3955 .0193 .0242 % .7686 % .8054 % 3.3762 % .0426 % .2196 % .1523 % .0074 % .0315 1.0000 1.0480 4.3928 .0554 .2858 .1982 .0097 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL UPPER INCISORS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 005039 492 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 203 ANIMAL NUMBER: C96028 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 259.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:00 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD) , HEART (HT), MUSCLE, SKELETAL I SM) . NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) * o o in o oH- I 493 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 204 ANIMAL NUMBER: C96029 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 239.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:41 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0817 1.9819 2.1671 8.7181 .1243 .5235 .2626 .0179 .0341 % .8275 % .9048 % 3.6401 % .0519 % .2186 % .1096 % .0075 % .0412 1.0000 1.0934 4.3989 .0627 .2641 .1325 .0090 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL 005041 494 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 205 ANIMAL NUMBER: C96029 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 239.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:41 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) ! a GG5042 4 495 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 206 ANIMAL NUMBER: C96030 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 243.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:22 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0640 2.0259 2.1625 10.3610 .1272 .5984 .2458 .0121 .0263 .8317 % .8877 % 4.2533 % .0522 % .2456 % .1009 % .0050 % .0316 1.0000 1.0674 5.1143 .0628 .2954 .1213 .0060 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY THYMUS (T H ) : -R E D FO C U S( I ) /A R E A (S ); R IG H T L N , M A N DIBU LAR (M N) : -D IF F U SE L Y RED; BILATERA L GENERAL COMMENT (G C ) : -B O N E MARROW SM EA R T A K E N LOBE: M ULTIPLE PIN PO IN T FOCI LIV ER (L I ) : -H Y PE R T R O PH Y , H E PA TO C ELLU LA R , C E N T R IL O B U L A R ,-M IN IM A L -I N F IL T R A T E , L Y M P H O H IS T IO C Y T IC ,-M IN IM A L -N E C R O S IS , C O A G U L A T IV E ,-M IN IM A L THYMUS (T H ) : -H E M O R R H A G E ,-M IN IM A L L N , M A N DIBU LAR (M N) : -H E M O R R H A G E ,-M IN IM A L 005043 496 A PPE N D IX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 207 ANIMAL NUMBER: C96030 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 243.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:22 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOW ING ORGANS WERE UNREMARKABLE A T N E C R O PSY : BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 208 ANIMAL NUMBER: C96031 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 205.5 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:34 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) 7.4421 3.6215 % NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER <UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL <TI), GENERAL COMMENT <GC) , |l I 1 005045 i 4 498 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.I 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 209 ANIMAL NUMBER: C96032 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 203.4 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:09 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 6.7736 ----------------------------- ---------------------- 3.3302 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT <GC) 005046 I 499 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE; 210 ANIMAL NUMBER: C96033 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 210.3 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:15 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 7.7835 ----------------------------- ---------------------- 3.7011 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM). NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 005047 500 ( APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS PAGE: 211 ANIMAL NUMBER: C96034 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 234.0 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 12:01 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE 2IMA 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) ---------------------- 8.8195 ----------------------------- ---------------------- 3.7690 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 005048 501 APPENDIX G Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 212 ANIMAL NUMBER: C96035 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 218.8 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:21 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STA TUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ---------------------- 7.2747 ----------------------------- ---------------------- 3.3248 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA) , DUODENUM (DU) , JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO) , RECTUM (RE) , LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 005049 502 i J 4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 213 ANIMAL NUMBER: C96036 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 253.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:45 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0611 2.1326 2.3286 9.7463 .1035 .4891 .3725 .0205 .0241 % .8416 % .9189 % 3.8462 % .0408 % .1930 % .1470 % .0081 % .0287 1.0000 1.0919 4.5701 .0485 .2293 .1747 .0096 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL oo SOS o 503 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 214 ANIMAL NUMBER: C96036 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/9B STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 253.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:45 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 005051 504 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.X 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 215 ANIMAL NUMBER: C96037 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 251.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:37 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0804 1.8602 2.3767 8.8940 .0918 .5405 .2792 .0196 .0320 % .7408 % .9465 % 3.5420 % .0366 % .2153 % .1112 % .0078 % NECROPSY OBSERVATIONS ORGAN TO BRAIN WEIGHT RATIO .0432 1.0000 1.2777 4.7812 .0493 .2906 .1501 .0105 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS o O Ui 505 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 216 ANIMAL NUMBER: C96037 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 251.1 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:37 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), STOMACH, GL (ST), STOMACH, NONGL (SU) esosoo 506 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 217 ANIMAL NUMBER: C96038 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT : 275..3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:14 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0554 2.1428 2.1681 9.8295 .1411 .4874 .2831 .0153 .0201 % .7784 % .7875 % 3.5705 % .0513 % .1770 % .1028 % .0056 % .0259 1.0000 1.0118 4.5872 .0658 .2275 .1321 .0071 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0B SERVATIONS HISTOPATHOLOGY LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL UTERUS (UT) : -LUMEN FILLED WITH FLUID; LEFT: CLEAR FLUID GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT UTERUS (UT) : >UNREMARKABLE 005054 507 j APPENDIX 6 Individuai Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE! 218 ANIMAL NUMBER: C96038 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 275.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:14 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) ssosoo I 508 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 219 ANIMAL NUMBER: C96039 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 257.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:13 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0835 2.0098 2.2091 9.1522 .1115 .4315 .3296 .0199 .0324 % .7805 % .8579 % 3.5543 % .0433 % .1676 % .1280 % .0077 % .0415 1.0000 1.0992 4.5538 .0555 .2147 .1640 .0099 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL { 005056 509 \ APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 220 ANIMAL NUMBER: C96039 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 257.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:13 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 005057 510 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 221 ANIMAL NUMBER: C96040 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 222.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:04 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0650 1.9359 2.3025 9.2333 .1810 .5292 .2778 .0253 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0292 % .8693 % 1.0339 % 4.1461 .0813 % .2376 % .1247 % .0114 % ORGAN TO BRAIN WEIGHT RATIO .0336 1.0000 1.1894 4.7695 .0935 .2734 .1435 .0131 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (G C ) : -B O N E MARROW SM EA R T A K E N -N O M ACRO SCO PIC L E S IO N S j 1 4 8S0S00 511 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 222 ANIMAL NUMBER: C96040 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 222.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:04 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), STOMACH, GL (ST), STOMACH, NONGL (SU) I ! i GS0S09 512 i f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 223 ANIMAL NUMBER: C96041 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 212.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:59 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0654 1.8020 1.8605 10.2446 .1083 .4309 .2212 .0158 .0308 % .8500 % .8776 % 4.8324 % .0511 % .2033 % .1043 % .0075 % .0363 1.0000 1.0325 5.6851 .0601 .2391 .1228 .0088 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATH O LO G Y GENERAL COMMENT (G C ) : -B O N E MARROW SM EA R T A K E N -N O M ACRO SCO PIC L E S IO N S LUNG (L U ) : -IN F IL T R A T E , MACROPHAGE, ALVEO LAR, -M IN IM A L LIV ER (L I ) : -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 IL O B U L A R ,-M O D E R A T E -IN F IL T R A T E , LY M PH O H ISTIO C Y TIC , -M IN IM A L -N E C R O S IS , IN D IV ID U A L H E P A T O C Y T E ,-M IN IM A L A UDITO RY SE B GL (A S ) : -O N E E X A M IN E D ,-P R E S E N T 005060 j 513 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 224 ANIMAL NUMBER: C96041 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 212.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:59 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL(SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM), NERVE, SCIATIC(SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV), OVARY (OV), VAGINA (VA) 'i T9OSCO I 514 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314,1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 225 ANIMAL NUMBER: C96042 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 228.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:00 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0619 2.0530 2.2573 13.7996 .1247 .4886 .2500 .0203 .0271 % .8973 % .9866 % 6.0313 % .0545 % .2135 % .1093 % .0089 % .0302 1.0000 1.0995 6.7217 .0607 .2380 .1218 .0099 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY G ENERAL COMMENT (G C ) : -B O N E MARROW SM EA R T A K E N -N O M ACRO SCO PIC L E S IO N S LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL KIDNEY (KD) : -INFLAMMATION, CHRONIC,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL STOMACH, GL (ST) : -EROSION,-MINIMAL G05062 { 515 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 226 ANIMAL NUMBER: C96042 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 228.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:00 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD) , HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 005063 516 t APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 227 ANIMAL NUMBER: C96043 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 218.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:54 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0754 2.0160 2.1708 9.1440 .1120 .4212 .2302 .0191 .0345 % .9235 % .9944 % 4.1887 % .0513 % .1929 % .1055 % .0087 % .0374 1.0000 1.0768 4.5357 .0556 .2089 .1142 .0095 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); UP TO 4 X 2 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN MUCOSA: MULTIPLE DARK BROWN AREAS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT STOMACH, GL (ST) : -EROSION,-MINIMAL ^90S00 I 517 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 228 ANIMAL NUMBER: C96043 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 218.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:54 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE. FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI) SKELETAL (PA), (SM), THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) S90S00 I 518 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 229 ANIMAL NUMBER: C96044 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 261.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:19 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0833 2.1839 2.4878 14.4781 .1201 .5592 .2968 .0194 .0319 % .8367 % .9532 % 5.5472 % .0460 % .2143 % .1137 % .0074 % .0381 1.0000 1.1392 6.6295 .0550 .2561 .1359 .0089 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY. HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL HEART (HT) : -DEGENERATION/NECROSIS,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL j ' I J 990S00 ( 519 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 230 ANIMAL NUMBER: C96044 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 261.0 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:19 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), MUSCLE, SKELETAL (SM), NERVE,SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) SOSOQ I 520 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 231 ANIMAL NUMBER: C96045 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 251.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:47 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0862 2.0735 2.6621 11.5067 .1738 .5999 .2968 .0316 .0343 % .8248 % 1.0589 % 4.5770 % .0691 % .2386 % .1181 % .0126 % .0416 1.0000 1.2839 5.5494 .0838 .2893 .1431 .0152 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY OVARY (OV) : -DIFFUSELY RED; BILATERAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL PANCREAS (PA) : -ATROPHY, ACINAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT UTERUS (UT) : -DILATATION,-SLIGHT OVARY (OV) : UNREMARKABLE 890S00 j 521 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 232 ANIMAL NUMBER: C96045 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 251.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:47 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB) , CERVIX (CV), VAGINA (VA) 005069 I 522 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 233 ANIMAL NUMBER: C96046 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 266.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:42 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0612 2.0991 2.2050 11.8714 .1311 .5352 .3266 .0186 .0229 % .7865 % .8262 % 4.4479 % .0491 % .2005 % .1224 % .0070 % .0292 1.0000 1.0505 5.6555 .0625 .2550 .1556 .0089 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR,CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL I , I * 005070 523 i I ,4 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 234 ANIMAL NUMBER: C96046 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 266.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:42 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 005071 524 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 235 ANIMAL NUMBER: C96047 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 213.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:53 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0586 2.0822 2.3414 12.2355 .1156 .4873 .3388 .0191 .0275 % .9762 % 1.0977 % 5.7363 % .0542 % .2285 % .1588 % .0090 % .0281 1.0000 1.1245 5.8762 .0555 .2340 .1627 .0092 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0B SERVAT ION S HISTOPATHOLOGY LIVER (LI) : -DIFFUSELY DARK; ALL LOBES : DARK BROWN UTERUS (UT) : -LUMEN FILLED WITH FLUID; GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BILATERAL: CLEAR FLUID LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR, -MINIMAL LIVER (LI) : -HYPERTROPHY,, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT UTERUS (UT) : -DILATATION,-SLIGHT f i 2 005072 525 I I f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 236 ANIMAL NUMBER: C96047 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 213.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:53 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP): THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDER IAN GLAND (HG) , AUDITORY SEB GL ( A S ) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN) , SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , CERVIX (CV) , OVARY (OV) , VAGINA (VA) i 005073 526 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 237 ANIMAL NUMBER: C96048 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 223.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:40 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0851 2.1074 2.3036 13.9635 .1738 .5093 .2971 .0252 .0380 t .9416 % 1.0293 % 6.2393 % .0777 % .2276 % .1328 % .0113 % .0404 1.0000 1.0931 6.6259 .0825 .2417 .1410 .0120 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY OVARY (OV) : -DIFFUSELY RED; BILATERAL: DARK RED BRAIN (BR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL LUNG (LU) : -INFLAMMATION, SUBACUTE,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL KIDNEY (KD) : -MINERALIZATION, TUBULAR, -MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT HARDERIAN GLAND (HG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL OVARY (OV) : >UNREMARKABLE < 005074 527 f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 238 ANIMAL NUMBER: C96048 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 223.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:40 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD NECROPSY O B S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LUJ, TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT). MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), VAGINA (VA) 005075 t 528 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 239 ANIMAL NUMBER: C96049 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 191.4 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 10:55 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0539 1.8149 1.7670 10.6923 .0973 .4078 .2422 .0173 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0282 % .9482 % .9232 % 5.5864 % .0508 % .2131 % .1265 % .0090 % ORGAN TO BRAIN WEIGHT RATIO .0297 1.0000 .9736 5.8914 .0536 .2247 .1335 .0095 ORGAN STATUS 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 DARK BROWN AREAS UP TO 5 X 1 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -TAIL - BENT/MISSING; TIP: MISSING; REMAINING PORTION COLLECTED LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL STOMACH, GL (ST) : -EROSION,-SLIGHT 005076 529 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 240 A N IM A L NUM BER: C96049 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 191.4 GRAMS D A T E A N D T IM E OF NECROPSY: 12/02/98 10:55 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) (SM), THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 005077 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 241 ANIMAL NUMBER: C96050 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 216.8 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 11:40 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0634 2.0287 1.9598 12.8289 .0985 .3976 .1845 .0195 .0292 % .9357 % .9040 % 5.9174 % .0454 % .1834 % .0851 % .0090 % .0313 1.0000 .9660 6.3237 .0486 .1960 .0909 .0096 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL i ? 1 J 005078 531 1 : APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 242 A N IM A L N UM BER: C96050 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE D A T E OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 216.8 GRAMS D A T E AND T IM E OF NECROPSY: 12/02/98 11:40 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA),, TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB) , UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 005079 532 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.I 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 243 ANIMAL NUMBER: C96051 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 181.0 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:19 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) 8.8661 4.8984 % NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 005080 1 533 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 244 ANIMAL NUMBER: C96052 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 202.7 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:52 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 8.9691 ----------------------------- ---------------------- 4.4248 % -.....-- ---------------------- --------------------------------------------- ----------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) T80S00 534 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 245 ANIMAL NUMBER: C960S3 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 191.0 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:55 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 8.3894 ----------------------------- ---------------------- 4.3924 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 005082 535 APPENDIX 6 individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 246 ANIMAL NUMBER: C96054 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 186.7 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:16 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA 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) ---------------------- 8.0181 ----------------------------- ---------------------- 4.2946 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 005083 536 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS PAGE: 247 ANIMAL NUMBER: C96055 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 178.9 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 11:28 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE 2IMA 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) ---------------------- 7.8851 ----------------------------- ---------------------- 4.4075 % ----------------------------- --------------------------------------------------------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) 005084 i 537 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 248 ANIMAL NUMBER: C96056 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 209.3 GRAMS D A T E AND TIME OF NECROPSY: 12/02/98 9:49 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0720 1.9559 1.9486 12.3563 .1065 .4034 .2087 .0187 .0344 % .9345 % .9310 % 5.9036 % .0509 % .1927 % .0997 % .0089 % .0368 1.0000 .9963 6.3175 .0545 .2062 .1067 .0096 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,- MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL UTERUS (UT) : -DILATATION,-SLIGHT 005085 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 249 ANIMAL NUMBER: C96056 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 209.3 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 9:49 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA) 980S00 539 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 250 ANIMAL NUMBER: C96057 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 250.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:39 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0614 2.1920 2.2779 13.2419 .1134 .3561 .2704 .0195 .0245 % .8750 % .9093 % 5.2862 % .0453 % .1422 % .1079 % .0078 % .0280 1.0000 1.0392 6.0410 .0517 .1625 .1234 .0089 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 3 X 1 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL KIDNEY (KD) : -MINERALIZATION, TUBULAR,-MINIMAL THYMUS (TH) : -INVOLUTION,-MINIMAL STOMACH, GL (ST) : >UNREMARKABLE UTERUS (UT) : -DILATATION,-MINIMAL ! I * 005087 540 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL, (N-MEFOSE, T-6314) IN RATS PAGE: 251 ANIMAL NUMBER: C96057 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 250.5 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:39 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) (SM), THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA) 005088 541 I APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 252 ANIMAL NUMBER: C96058 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 246.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:55 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) .0527 2.0848 2.0803 11.7380 .0992 .5123 .2728 .0157 .0214 % .8451 % .8433 % 4.7580 % .0402 % .2077 % .1106 % .0064 % .0253 1.0000 .9978 5.6303 .0476 .2457 .1309 .0075 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN GENERAL INFORMATION (XX) : >NOTE:>ANIMAL NECROPSIED OUT OF ORDER DUE TO MORIBUND CONDITION FOLLOWING BLOOD COLLECTION LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, DIFFUSE,-SLIGHT THYMUS (TH) : -HEMORRHAGE,-MINIMAL -INVOLUTION, -MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PANCREAS (PA) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL 005089 : 542 4 \ APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 253 ANIMAL NUMBER: C96058 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 246.7 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 7:55 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 005090 543 i APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 254 ANIMAL NUMBER: C96059 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 207.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:25 PROSECTOR: JODI THIEREN RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD 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) L I V E R (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) .0551 2.0062 2.0576 11.4068 .1254 .4387 .1931 .0137 .0265 % .9650 % .9897 % 5.4867 % .0603 % .2110 % .0929 % .0066 % .0275 1.0000 1.0256 5.6858 .0625 .2187 .0963 .0068 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT UTERUS (UT) : -DILATATION,-SLIGHT j j J 005091 544 ( !f APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUQROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 255 ANIMAL NUMBER: C96059 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 207.9 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 8:25 PROSECTOR: JODI THIEREN RECORDER: STEVE VAN ADESTINE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA) 005092 545 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK d i e t a r y t o x i c i t y s t u d y w i t h n -m e t h y l PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 256 ANIMAL NUMBER: C96060 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 249.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:19 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY 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) .0718 2.0579 2.5943 13.5240 .1100 .4646 .3518 .0313 .0288 % .8245 % 1.0394 % 5.4183 % .0441 % .1861 % .1409 % .0125 % .0349 1.0000 1.2607 6.5717 .0535 .2258 .1710 .0152 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY THYROID (TY) : >NOTE:TRIMMING COMMENT: ONE THYROID/PARATHYROID NOT FOUND IN WET TISSUE AT TRIMMING PARATHYROID (PT) : >NOTE:TRIMMING COMMENT: ONE THYROID/PARATHYROID NOT FOUND IN WET TISSUE AT TRIMMING GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT -ONE EXAMINED,-PRESENT PARATHYROID (PT) : -ONE EXAMINED,-PRESENT 005093 546 t APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-22 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 257 ANIMAL NUMBER: C96060 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 249.6 GRAMS DATE AND TIME OF NECROPSY: 12/02/98 12:19 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) 005094 i 547 APPENDIX 7 Covance 6329-225 3M T-6314.1 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation NOTE: This appendix of the report contains information supplied by Pathology Associates International and has been reviewed by the Quality Assurance Unit of Pathology Associates International. 005095 Covance 6329-225 3M T-6314.1 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation (to be provided by Pathology Associates International) 549 005096 APPENDIX 8 Client-Supplied Items Covance 6329-225 3M T-6314.1 Note: This appendix contains information supplied by the Sponsor and has been reviewed by the Quality Assurance Unit o f [insert client name]. 005097 550 Client-Supplied Items Covance 6329-225 3M T-6314.1 005098 551 Covance is an independent, publicly held company operating in over 15 countries and over 30 offices worldwide, with headquarters in Princeton, New Jersey, USA. "r Covance is the marketing name for Covance Inc. and its subsidiaries around the world, the principal ones o f which are listed on this page. T he use o f "Covance" in this report refers to one or more of these and other subsidiaries. THE AMERICAS Princeton 1.800.773.0011 EUROPE Brussels +32.2.773.29.10 ASIA/PACIFIC Singapore +65.7747233 COVANCE LABORATORIES Madison, Wl, USA 888-541-LABS (5227) Vienna, VA, USA 800-742-8378 Harrogate. UK 011 44 1423 500011 Munster. Germany 011 49 251 97980 005099 COVAi^I> THE DEVELOPMENT SERVICES COMPANY Shaping Solutions PRINfED IN U.S A.