Document b5rrYK27L1QmKxgQKjB2eOd4y

THE DEVELOPMENT SERVICES COMPANY Sponsor: 3M St. Paul, Minnesota FINAL REPORT Study Title: 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Author: Peter J. Thomford, PhD Study Completion Date: June 30, 2000 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 560 QUALITY ASSURANCE STATEMENT Covance 6329-225 3M T-6314.1 This report, with the exception o f Appendix 7, has been reviewed by the Quality Assurance Unit o f Covance Laboratories Inc., in accordance with the Food and D rug Administration (FDA) Good Laboratory Practice Regulations, 21 CFR 58. The data in Appendix 7 is generated by and is the responsibility o f the Sponsor. The following inspections were conducted and findings reported to the study director and study director management. Inspection Dates From To 08/31/98 08/31/98 08/31/98 08/31/98 04/12/99 04/29/99 04/02/99 04/07/99 06/02/99 06/02/99 04/19/00 04/20/00 04/28/00 04/28/00 04/28/00 04/28/00 Phase Protocol Review Material Dispensation Report Review . Data Review Protocol Amendment Review Report Review Protocol Amendment Review Protocol Amendment Review Date Reported to Study Director and Study Director M anagement 08/31/98 08/31/98 04/29/99 05/04/99 06/02/99. 04/20/00 04/28/00 04/28/00 Representative Quality Assurance Unit Date/ S o A o-vt* 2 Covance 6329-225 3M T-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 M onitor Andrew M. Seacat, PhD 3M Toxicology Services 651.575.3161 Alternate Study Monitor Marvin T. Case, DVM, PhD 3M Toxicology Services 651.733.5180 Study Location Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Study Director Peter J. Thomford, PhD Covance Laboratories Inc. P.O. Box 7545 Madison, Wisconsin 53707-7545 608.241.7207 Study Timetable Study Initiation Date In-Life Start Date In-Life End Date Study Completion Date August 27, 1998 September 1, 1998 December 2, 1998 June 30, 2000 3 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 4 Covance 6329-225 3M T-6314.1 CONTENTS A B S T R A C T ............................................................................................................. PURPOSE............................................ -.................................................................. REGULATORY COMPLIANCE......................................................................... TEST MATERIAL................................................................................................. Test M aterial....................................................................................................... Reserve (Archive) Sample................................................................................. D isposition........................................................................................................... ANIMALS AND HUSBANDRY........................................................................ Test Animal......................................................................................................... Identification....................................................................................................... Acclimation........ ................................................................................................. Housing and M aintenance................................................................................ Justification......................................................................................................... P R O C E D U R E S ....................................................................................................... Group Designations and Dose Levels.............................................................. Dose Preparation............................................................................................... Retention Sam ples............................................................................................. Method o f Administration................................................................................. Dose Analyses.................................................................................................... Clinical Observations........................................................................................ Body W eights..................................................................................................... Food Consumption............................................................................................ Ophthalmology............................................................................................... .. Clinical Pathology.............................................................................................. Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination......... N ecropsy.............................................................. -............................................. Organ Weights.................................................................................................... Cell Proliferation Tissue Collection and Immunohistochemical Evaluation Palmitoyl-CoA Oxidase Tissue Collection and Analyses.............................. Liver PFOS Analyses............................................................ -........................... Tissue Preservation............................................................................................ H is to p a th o lo g y ................................................................................................... Statistical Analyses............................................................................................ RECORD R ET EN TIO N ...................................................................................... Page .....8 ....11 ....11 ....11 ....11 .... 11 ....11 ....12 .... 12 .... 12 .... 12 .... 12 .... 13 .... 13 .... 13 .... 14 .... 15 .... 15 .... 15 .... 16 .... 16 .... 16 .... 17 .....17 .....18 .... 18 .... 19 .....19 .....19 .....19 .....20 .....20 .....21 .....21 5 Covance 6329-225 3M T-6314.1 CONTENTS (Continued) Page R E S U L T S .....................................................................................................................................2 2 Dose Analyses......................................................................................................................... 22 Clinical Observations and Survival....................................................................................... 23 O phth a lm o lo g y ...................................................................................................................... 23 Body W eights........................................................................................................................ 23 Food Consumption............................................................................................................... 23 Test Material Consumption................................................................................................. 24 Clinical Pathology................................................................................................................. 24 Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination............................ 25 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation.................. 25 Liver PFOS Determination...................................................................................................25 Anatomic Pathology.......................................... ....................................................................25 C O N C L U S IO N S ....................................................................................................................... 2 6 S IG N A T U R E S ........................................................................................................................... 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.........................................................................39 General Codes and Abbreviations........................................................................................ 40 Codes for Clinical Pathology................................................................................................41 Abbreviations and Units for Clinical Hematology.............................................................44 Abbreviations and Units for Clinical Chemistry................................................................ 46 Abbreviations and Units for Clinical Urinalysis................................................................. 48 Codes for Anatomic Pathology........................................................................................... 49 TABLES 1 Results o f Homogeneity Analyses (ppm )..................................................................... 51 2 Results o f Stability Analyses (ppm )................................... ;......................................... 52 3 Results o f Dose Preparation Analyses (ppm ).............................................................. 55 4 Summary of Clinical Observations.................. ;.............................................................56 5 Summary of Ophthalmic Observations..........................................................................58 6 Summary o f Body Weight Data (g )...............................................................................59 7 Summary of Body Weight Change Data ( g ) ................................................................61 8 Summary o f Food Consumption Data (g).................................................................... 63 6 Covance 6329-225 3M T-6314.1 CONTENTS (Continued) Page TABLES 9 Summary o f Test Material Consumption Data (mg/kg/day).................................... 65 10 Summary of Clinical Hematology Data - W eek 5........................................................ 67 11 Summary of Clinical Hematology Data- Week 14.......................................................71 12 Summary o f Clinical Chemistry Data - Week 5 ........................................................... 75 13 Summary o f Clinical Chemistry Data - Week 14.......................................................... 81 14 Summary o f Clinical Urinalysis Data - Week 1 4 .......................................................... 87 15 Summary o f Organ Weight Data - Week 5 Sacrifice................................................... 89 16 Summary o f Organ Weight Data - Week 14 Sacrifice.................................................91 17 Incidence o f Macroscopic Observations......................................................................109 18 Incidence o f Microscopic Observations.......................................................................112 19 Incidence o f Severity o f Selected Microscopic Observations....................................121 APPENDIX 1............................................................................................................................. 124 Protocol Deviations.............................................................................................................. 125 Protocol................................................................................................................................... 127 Protocol Amendment No. 1 .................................................................................................144 Protocol Amendment No. 2 .................................................................................................146 Protocol Amendment No. 3 .................................................................................................149 APPENDIX 2 ............................................................................................................................. 151 Individual Animal Fate Data.................................................................................................152 Individual Clinical Observations.......................................................................................... 157 Individual Ophthalmic Observations................................................................................... 123 APPENDIX 3 ............................................................................................................................. !89 Individual Body Weight Data ( g ) ........................................................................................190 APPENDIX 4 .............................................................................................................................21 Individual Food Consumption Data (g )............................................................................. 202 Individual Test Material Consumption Data (mg/kg/day)................................................213 APPENDIX 5 .............................................................................................................................223 Individual Clinical Hematology D ata..................................................................................224 Individual Clinical Chemistry D a ta .............................................................. Individual Clinical Urinalysis D ata...................................................................................... 276 APPENDIX 6 .............................................................................................................................288 Individual Anatomic Pathology D ata..................................................................................289 APPENDIX 7 .................................................................................. Cell Proliferation R eport...................................................................................................... ^47 7 248 ABSTRACT Covance 6329-225 3M T-6314.1 The purpose of this study was to assess the toxicity o f the test material, N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) when administered in the diet to rats for at least 13 weeks. Four groups of 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 o f treatment and weekly thereafter. Food consumption data were collected weekly. Ophthalmic examinations were done before initiation o f treatment and during Week 14. Blood samples were collected for hematology and clinical chemistry tests during Weeks 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 Week 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. 8 Covance 6329-225 3M T-6314.1 One female given 3 ppm N-MeFOSE was sacrificed on Day 59 due to severe laceration of 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 m aterial Statistically significantly lower mean body weights were noted beginning at W eek 4 and continuing through the end o f study for animals given 100 ppm. Statistically significantly lower mean body weights were noted beginning at Week 7 and continuing through the end o f study for males given 30 ppm. Body weight changes were statistically significantly lower in a sporadic manner for animals given 30 or 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 Weeks 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 of 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. 9 Covance 6329-225 3M T-6314.1 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 o f males and females in the 100 ppm group only. No test material-related changes were seen in animals fed 3 ppm of 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 of 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 anatomic pathology, clinical pathology, and body weight effects at 30 and 100 ppm the no-observable-adverse-effect level was determined to be less than 30 ppm when N-MeFOSE is administered at concentrations of 0, 3, 30 and 100 ppm to Crl:CD(SD) IGS BR rats for at least 13 weeks through dietary administration. Based on the body weight effects at 3, 30, and 100 ppm, the no-observable-effect level was determined to be less than 3 ppm when N-MeFOSE is administered at concentrations of 0, 3, 30 and 100 ppm to Crl:CD (SD) IGS BR rats for at least 13 weeks through dietary administration. In the absence o f correlative changes in anatomic pathology and clinical pathology the body weights effects at 3 ppm were not considered to be biologically adverse. Covance 6329-225 ._______________________ ____________________________________________ 3M T-6314.1 PURPOSE The purpose o f 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. REGULATORY COMPLIANCE All aspects of 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. F -l 1364, 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. D isposition Remaining test material will be returned after authorization from the Sponsor. 11 ANIMALS AND HUSBANDRY Covance 6329-225 3M T-6314.1 Test Anim al Male and female Crl:CD(SD) IGS BR rats were obtained from the Portage, Michigan, facility of 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 of treatment, a microchip identification device was implanted into each animal After randomization for placement on test, each animal was assigned a permanent number, and the microchip was coded with that number. All data for an animal are recorded under these numbers. Acclim ation 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 o f health problems, an ophthalmic examination was done, and body weights were recorded for all animals at randomization. Housing and M aintenance 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. 12 Covance 6329-225 3M T-6314.1 Certified rodent diet #5002 meal, (PMI Nutrition International) was provided (see Protocol Deviations for exceptions) a d 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, 2, and 3. The protocol, protocol amendments, and protocol deviations are in Appendix 1. Group D esignations 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 o f randomization, the weight variation o f the animals for each sex used did not 13 Covance 6329-225 3M T-6314.1 exceed 2 standard deviations of the mean weight. Group mean body weights were analyzed using Levene's test for homogeneity of variance at the 5.0% probability level and found to be homogeneous. Animals were assigned to the study according to the following design: Number of Animals Dietary Levels Group Male Female (ppm MeFOSE)3 1 (Control)b 20 20 0 2 (Low) 3 (Mid) 20 20 20 20 3 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 of 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 aratio n o f 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 reparation o f Diets for G roups 2 through 3. Each dose level was prepared independently. A specified amount o f 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 aratio n o f D iet for G roup 4. A specified amount o f diet was weighed into a labeled container. The required amount of test material was weighed and transferred into a labeled container. Approximately 5 mL o f acetone was added to the container and mixed manually. Increments o f approximately 5 mL acetone were added as necessary until the test material had dissolved. To prepare a premix, the diet was transferred into a labeled 14 Covance 6329-225 3M T-6314.1 Hobart mixing bowl. The test material and acetone were added to the mixing bowl, overlaid with a portion o f diet from the mixing bowl, and thoroughly mixed. A portion o f diet from the mixing bowl was transferred to a second mixing bowl, mixed manually to recover residual test material, and returned to the first mixing bowl. The contents o f the mixing bowl were thoroughly mixed. 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 Sam ples 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). M ethod of Adm inistration 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 of 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. 15 Covance 6329-225 3MT-6314.1 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 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 W eights Individual body weight data were recorded on the first day of treatment, and weekly thereafter. Food Consum ption Individual food consumption data were recorded weekly during treatment. Food consumption was not measured during Week 5 for animals scheduled for sacrifice during W eek 5. 16 Covance 6329-225 3M T-6314.1 Ophthalm ology Ophthalmic examinations were done before initiation o f treatment and during Week 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 17 volume specific gravity pH protein glucose ketones Covance 6329-225 3M T-6314.1 U rin alysis bilirubin blood urobilinogen microscopic examination of sediment appearance Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determ ination During Weeks 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 of 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 of 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 of the carcass; all external body orifices; the abdominal, thoracic, and cranial cavities; organs; and tissues. 18 Covance 6329-225 3M T-6314.1 Organ W eights After 13 weeks o f treatment, the following organs (when present) were 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 Inununohistochem ical 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 are in Appendix 7. Palm itoyl-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 of these analyses will be reported separately by the Sponsor. 19 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: adrenal (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 H istopathology 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. 20 Covance 6329-225 3M T-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 o f each animal were prepared at the scheduled sacrifice after 13 weeks of 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 of heterogeneity of variance at p ^ 0.05, transformations were used to stabilize the variance. Comparison tests took variance heterogeneity into consideratioa 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 of treatment was analyzed statistically. RECORD RETENTION All raw data, documentation, records, protocol, and specimens generated as a result o f this study will be archived in the storage facilities o f Covance-Madison for a period o f 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 of the final report will be retained by Covance-Madison. PCNA evaluation data, paraffin blocks, and tissue slides will be retained by Pathology Associates International. 21 Covance 6329-225 ____ 3MT-6314.1 Liver and serum samples sent to the Sponsor and analysis data generated from these samples will be retained by the Sponsor. RESULTS 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% of 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 of 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 of 500 ppm. 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. 22 a Covance 6329-225 3M T-6314.1 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. No clinical observations were noted that were considered effects o f the test material Ophthalm ology Ophthalmic observations are summarized in Table 5; individual data are in Appendix 2. The Ophthalmology Report contains a discussion of the data. Animals selected for the study had no lesions at the prestudy examination. No test material-related ophthalmic observations were noted at the Week 14 examination. Body W eights 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 30 and 100 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 of 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-MeFOSE. Food Consum ption Food consumption data are summarized in Table 8; individual data are in Appendix 4. 23 Covance 6329-225 3M T-6314.1 Although statistically significant only at Week 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 o f the study. Females given 100 ppm had statistically significantly lower food consumption than those of controls at Weeks 3 ,4 , 6, 7 ,1 1 , 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. Test M aterial Consum ption 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 of 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-M eFOSE, 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 ppmN-M eFOSE, 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 of 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 24 Covance 6329-225 3M T-6314.1 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. Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determ ination Results o f serum PFOS level determination will be reported separately by the Sponsor. Cell Proliferation Tissue Collection and Imm unohistochem ical Evaluation Results o f cell proliferation and immunohistochemical evaluation provided by Pathology Associates International are in Appendix 7. Liver PFOS Determ ination Results o f liver PFOS level determination will be reported separately by the Sponsor. Anatom ic 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 of 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. 25 Covance 6329-225 3M T-6314.1 Test material-related macroscopic findings were noted at a low incidence in the liver and glandular stomach of 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 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. CONCLUSIONS Based on anatomic pathology, clinical pathology, and body weight effects at 30 and 100 ppm the no-observable-adverse-effect level was determined to be less than 30 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. Based on the body weight effects at 3, 30, and 100 ppm, the no-observable-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. In the absence o f correlative changes in anatomic pathology and clinical pathology the body weights effects at 3 ppm were not considered to be biologically adverse. 26 SIGNATURES Covance 6329-225 3M T-6314.1 * Kf Nii'van Bruce-Konuah Study Coordinator Covance Laboratories Inc. Covance Laboratories Inc. T U #?-*Date 3 0 /2*jz-^rm 27 REFERENCES Covance 6329-225 ____ 3M T-6314.1 Dunnett, C. W., "New Tables for Multiple Comparisons with a Control," Biometrics. 20:482-491 (1964). Levene, H., "Robust Tests for Equality of Variances," Contributions to Probability and Statistics, (eds.) I. Olkin et aL, Ch. 25, pp. 278-292, Stanford University Press: Stanford, California (1960). Winer, B. J., "Design and Analysis 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 3 OPHTHALMOLOGY REPORT Covance 6329-225 3M T-6314.1 Ophthalmic examinations were done before initiation o f treatment and during Week 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. C/Vv-r-^S [Donna J. Cltaons, DVM, MS giornate, AO ,Loop 29 PATHOLOGY REPORT Covance 6329-225 3M T-6314.1 SUMMARY The purpose o f this study was to assess the toxicity o f 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 of 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 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 30 Covance 6329-225 3M T-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 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 of minimal hepatocellular vacuolation occurred in 30 ppm dose group males, and the liver of 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 of 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 o f Crl:CD(SD) IGS BR rats (20 animals/sex/group) were fed diets containing the test material at a dose level of 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 o f 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 Weeks 5 and 14. Urine was collected for urinalysis tests during W eek 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 of fiver were collected at the terminal sacrifice for evaluation o f proliferation cell nuclear antigen (PCNA; by Pathology Associates International; five animals/sex/group), and both scheduled sacrifices for determination o f 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 W eek 9 (unscheduled sacrifice). In addition, livers, stomachs, and macroscopic 31 Covance 6329-225 3M T-6314.I lesions were examined from all terminal sacrifice animals fed 30 ppm, and macroscopic lesions and livers only were examined from animals fed 3 ppm. Statistically significant differences cited in the Results and Discussion section are based on comparisons between the control and treated groups. RESULTS A M ) DISCUSSION M ortality One female fed 3 ppm (Animal No. C96016) was sacrificed during W eek 9 (Day 59) because of poor health. All other animals survived to the respective scheduled sacrifice. Clinical Pathology W eeks 5 an d 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 W eek 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 o f the hepatocellular degeneration, and mildly higher hepatic palmitoyl CoA oxidase was indicative of peroxisomal proliferation. The effects on cholesterol and triglycerides were the most prominent findings, and suggested lipid metabolism by the liver was altered. 32 Covance 6329-225 3M T-6314.1 Of 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 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. Terminal 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 ppm N-MeFOSE. 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 p p m 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. 33 Covance 6329-225 3M T-6314.1 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 of normal biologic variation or 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 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 of 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 of 15, 0 of 1 4,0 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 of 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. 34 Covance 6329-225 3M T-6314.1 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 of pertinent liver findings is presented in Text Table 1. Text Table 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 0 0 0 0 Hypertrophy, hepatocellular, Centrilobular 0 0 14 15 Necrosis, coagulative 00 03 Pigment, hepatocellular 00 02 Vacuolation, hepatocellular, centrilobular to midzonal Vacuolation, hepatocellular, diffuse 0 0 27 00 22 000 1 0 0 7 14 00 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 of 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 of 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 of 15 females fed 30 ppm was likely related to dietary administration of 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 of 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 35 Covance 6329-225 _____3MT-6314.1 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 o f 15 in females in the control, 30 ppm, and 100 ppm groups respectively. The presence o f erosions microscopically generally correlated with the dark foci or areas seen 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 of rats of this age and strain. Robert L. Hall, DVM, PhD Diplomate, ACVP (Clinical Pathology) Diplomate, ACVP Diplomate, ABT 36 Covance 6329-225 3M T-6314.1 COMMENTS ON THE DATA Various models o f calculators, computers, and computer programs were used to analyze data in this study. Because different models round off or truncate numbers differently, values in some tables (e.g., means, standard deviations, or individual values) may differ slightly from those in other tables, from individually calculated data, or from statistical analysis data. Neither the integrity nor the interpretation 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 o f the study. The summary table for clinical observations indicate the number o f animals for which a condition was observed without regard to the specific nature, severity, reversibility, number of 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 of each group for each sex. The day o f initiation o f treatment is "Day 1, Week 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., W eek 1 values are indicated as "Day 8."). Weekly food consumption and test material consumption are calculated from the first day o f the study week to the first day o f the following study week (e.g., Week 1 values are calculated from Day 1 through 7). The values for summary and individual test material consumption are reported with more significant figures than is appropriate for the data due to limitations o f the data collection and reporting software. 37 Covance 6329-225 3M T-6314.1 COMMENTS ON THE DATA (Continued) 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 of 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. The calculation for individual test material consumption is: Test material consumption = __________________________ Diet ConcentrationxFood Consumption__________________________ Food Consumption Intervalx[Fiist Body Weight o f Interval+ (Daily Body Weight GainxDay Factor)] where: Daily Body Weight Gain = ______ Last Body Weight of Interval- First Body W eight o f Interval______ Day of Last Body Weight o f Interval- Day of First Body Weight of Interval and: Day Factor = _ ,^ ^^ e r Food Consumption Interval (Food Consumption Start Day- Day o f First Body Weight of Interval)+ ------------------- ----------------- and: Food Consumption Interval = Food Consumption End Day- Food Consumption Start Day 38 ____ _______________________ _____________________C_o_v_an3cMe 6T3-2693-1242.15 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 Note: The following lists o f codes, abbreviations, and units are used by Covance. Some, but not necessarily all, of this information may be needed for this report. 39 Covance 6329-225 3M T-6314.1 General Codes and Abbreviations WK N Mean; MEAN SD; S.D.; STAND DEV; STANDARD DEV; sd * -;N A P C UNSCHED DISPATCH TBW # CO Week. Number o f measurements in a group. Arithmetic mean. Standard deviation. Group mean is significantly different from the mean o f the control group (Group 1) at p s, 0.05. No value; not applicable; not present. Present. Comment found at the end of each group for each sex. Unscheduled. Observations transferred from the in-life module o f the data collection system to the necropsy module for reference during necropsy. Observations are duplicates of the last in-life observations. Terminal body weight. Number. Clinical observatioa Anim al D eath Codes: 1 T M Interim sacrifice 1. Terminal sacrifice. Sacrificed at an unscheduled interval 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 of invalid data) Recording error (recorded incorrect data, e.g., wrong number, spelling error, incorrect date) Entry error (incorrect keyboard entry) Sampling error Platelets clumped Platelets decreased Platelets increased Platelets large Platelets appear adequate Color interferes with test Heinz bodies observed Plasmodium No aggregation Fractious Unable to determine No coagulation 41 Covane* 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 of 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 Moderate Many A Pale B Straw C Yellow D Dark yellow URINE APPEARANCE Color E Amber F Brown G Red H Green I Black P Blue/green Q Blue R Orange Clarity J Clear K Hazy L Cloudy Miscellaneous M Debris 0 Feces 42 Covance 6329-225 3M T-6314.1 Codes for Clinical Pathology (Continued) URINE CHEMISTRY MULTISTIX STRIP Urine Glucose - + ++ +++ ++++ +++++ Negative 100 mg/dL 250 mg/dL 500 mg/dL 1,000 mg/dL 2,000 mg/dL Urine Ketone - + ++ +++ ++++ +++++ Negative 5 mg/dL 15 mg/dL 40 mg/dL 80 mg/dL 160 mg/dL Urine Blood - Negative + Small ++ Moderate +++ Large Urine Urobilinogen + ++ +++ ++++ 0.2 mg/dL 1 mg/dL 2 mg/dL 4 mg/dL 8 mg/dL (1 mg = approximately 1 Ehrlich unit) Urine Bilirubin - Negative + Small ++ Moderate +++ Large URINE SEDIM ENT 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 B a cteria 0 Not present 1 Few 2 Moderate 3 Many 43 Covance 6329-225 3M T-6314.1 Abbreviations and Units for Clinical Hem atology 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 (U nits) RBC (E6/UL or X106///L) HGB (G/DL) HCT (%) M C V (FL) MCH (PG) MCHC (%) PLT (E3/UL or XlOV/dL) M PV (FL) RETIC (%) RETTC (E3/UL or XIOV^L) HEINZ (%) ESR (MM/HR) PT (SEC) PTT (SEC) TT (SEC) ACT (SEC) FBR (MG/DL) FDP (UG/ML) PAGG/COL (%) PAGG/ADP (%) ANTIPLAS (%) BLE TIME (SEC) METHGB (%) PLAHGB (MG/DL) M/E RATIO EST M/E RATIO WBC (E3/UL or X103//zL) NRBC (/100 WBC) COR WBC (E3/UL or X103//L) N-SEG (E3/UL or X103/L) and % N-BAND (E3/UL or X103///L) and % LYMPH (E3/UL or X103/^L ) and % MONO (E3/UL or X103/^L) and % EOSIN (E3/UL or X103///L) and % BASO (E3/UL or XIOV//L) and % ANISO (-,1,2,3) POLY (-,1,2,3) 44 Covance 6329-225 3M T-6314.1 A bbreviations and Units for Clinical Hem atology (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) 45 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 B IU (MG/DL) D B IU (MG/DL) IB IL I (MG/DL) CHOL (MG/DL) TRIG (MG/DL) UN/CREAT (RATIO) T LIPIDS (MG/DL) P LIPIDS (MG/DL) HDL (MG/DL) LDL (MG/DL) UA (MG/DL) AST/SGOT (IU/L) ALT/SGPT (IU/L) ALK PHOS (IU/L) GGT (IU/L) SDH (IU/L) LDH (IU/L) CK (IU/L) AMYLASE (IU/L) LIPASE (IU/L) PCOAO (IU/G) CA (MG/DL) ION CA (MG/DL) I PHOS (MG/DL) NA (MMOL/L) K (MMOL/L) CL (MMOL/L) MG (MEQ/L or MG/DL) ZN (MG/L or PPM) SR (MG/L or PPM) FE (UG/DL) 46 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) H B C (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) 47 Covance 6329-225 _____3MT-6314.1 Abbreviations and Units for Clinical Urinalysis Test Urine volume 8 hour urine volume Specific gravity Urine osmolality Quantitative urinary/cerebrospinal fluid protein Urine protein excretion Urine chemistry Multistix strip Urine pH Urine protein Urine glucose Urine ketones Urine bilirubin Urine blood Urine urobilinogen Urine reducing substances Microscopic examination 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) SPGR U OSMO (MOSM/KG) QUAN PRO (MG/DL) PRO EXC (MG) UPH U PRO (MG/DL) UGLU UKET U BILI U BLOOD UROBILI U RE SUB RBC (PER HPF) WBC (PER HPF) EPITH (PER HPF) BACT (PER HPF) CASTS (PER LPF) CRYSTALS (PERLPF1 or PER LPF2) URINE APPI or URINE APP2 COMMENTS Miscellaneous Codes and Abbreviations for Clinical Pathology Fecal occult blood Fecal parasite detection Hemolytic potential Osmolality Not applicable N ot applicable N ot applicable OSMO (MOSM/KG) 48 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 MACROSCOPIC CODES Indicates that organ weight is excluded from calculations Organ weight not taken; explanation given in necropsy notes Organ missing or lost Organ technically unsuitable for weighing Organ autolyzed and could not be weighed Weight was taken, but was excluded from all calculations MICROSCOPIC CODES Codes Prefacing Neoplastic Findings B- Primary, benign neoplasm M Primary, malignant neoplasm N Metastatic neoplasm I Locally invasive neoplasm X- Other neoplasm Code Definition Distribution of Findings Focal Diffuse Multifocal 49 Covance 6329-225 3M T-6314.1 Codes for Anatom ic Pathology (Continued) 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 of change with possible loss o f function o f the affected cells or organs 5 Severe - a great amount of change with probable loss of function of the affected cell or organs and frequently involves large areas o f the organ Other M icroscopic Codes TL Total P Finding present - Finding not present MN Mean TISSUE ABBREVIATIONS A bbreviation 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 D efin ition 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 50 Table 1 Covance 6329-225 3M T-6314.1 Results o f 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 Middle 1 2 3 Mean 1 2 3 Mean 2.19 2.43 2.09 2.24 (74.7)a 33.7 27.8 25.6 29.0 (96.7) 79.4 76.5 76.7 77.5 (77.5) 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 51 Table 2 Covance 6329-225 3M T-6314.1 Results of 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 temperatureb 8 week, frozen 1 2 Mean 1 2 Mean 0.709 0.850 0.780 (78.0) 0.779 0.995 0.887 (88.7) - _ - a Each value in the parenthesis is the percent o f theoretical b Reinjected 52 v Covance 6329-225 3M T-6314.1 Table 2 (Continued) Results of 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 of theoretical. 53 Covance 6329-225 3MT-6314.1 Table 2 (Continued) Results o f 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. 54 Covance 6329-225 3M T-6314.1 Table 3 Results of Dose Preparation Analyses (ppm) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Week Replicate 0 1-4 1 a 2a Mean - 1-4C 1 2 Mean _ - l-4d 1 2- Mean - 5-8 1 a 2a Mean a 9/12 1 a 2a Mean a 13/14 1 2 Mean a a a T-6314 (ppm) 3 30 100 2.16 29.7 2.12 27.0 2.14(71.3)" 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) - - 3.55 3.05 3.30(110) 27.9 27.0 27.5 (91.7) 89.3 82.3 85.8 (85.8) 2.24 2.49 2.37 (79.0) 27.6 26.8 27.2 (90.7) 89.7 87.2 88.5 (88.5) 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. 55 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 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 00001000 36341331 00000001 00010000 00 001 000 01 000 00 0 10000000 00010000 00010000 00010000 Covance 6329-225 3M T-6314.1 PAGE: 1 DAYS 1-93 CATEGORY KEYWORD QUALIFIER SKIN & 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 -- 1[ALE-- -- -- -- FE* [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 57 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 Week 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-- -- FEMALE-- 12 341 234 0 3 30 100 0 3 30 100 15 15 15 15 15 15 15 15 01 000 000 0 0 0. 1 0 0 0 0 00100 000 Covance 632$-225 3M T-6314.1 PAGE: 1 SEX GROUP: DOSE: WEEK UNITS : i 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 Table 6 Summary of Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS MALE 2 3 PPM 3 30 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 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 20 236 21.7 15 247 22.9 15 255 25.5 FEMALE 2 3 PPM 3 30 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 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 59 WEEK flWY - GROUP : DOSE: UNITS: 1 0 PPM 8N 15 MEAN 452 S.D. 26.9 9N 15 MEAN 475 S.D. 28.1 10 N MEAN S.D. 15 490 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 MEAN S.D. 15 547 38.6 Table 6 Summary of Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314 IN RATS 2 3 PPM 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 3 30 PPM 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 15 270 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 SEX: GROUP: DOSE: WEEK UNITS: 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. 1 0 PPM 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 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 -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 -FEMALE23 3 30 PPM 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 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 61 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 SEX: GROUP: DOSE: WEEK UNITS: 1 0 PPM --------- MALE2 3 PPM 3 30 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 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 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 Table 8 Summary of Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS SEX: GROUP : DOSE: WEEK UNITS : 1 0 PPM -------- MAIj E --------------------------- 23 3 30 PPM PPM 1N 20 MEAN 169 S.D. 12.3 2N 19 MEAN 176 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 14 176 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 4 100 PPM 20 168 8.6 20 176 9.1 19 173 8.0 20 176 10.8 15 166 9.4 15 182 9.4 15 182 8.5 1 0 'PPM 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 FEMALE23 3 30 PPM PPM 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 63 SEX: GROUP : DOSE: WEEK 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 2 3 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 3 30 PPM 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 4 100 PPM 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 12 136 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 64 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: -------------- 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 0.276 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 7.67 5 0.703 14 7.325 0.627 Covance 6329-225 3M T-6314.1 PAGE: 1 65 < 1 Table 9 Summary of Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL T.DDITTi-inDnnPT&NESniiFONAMIDO ETHANOL (N-MEFO00 TM H I T S ---- -- -- -- - - - SEX: GROUP : DOSE: TTNTTK : 2 3 PPM 3 30 PPM 100 PPM 2 3 PPM 3 30 PPM 4 100 PPM 8N MEAN S.D. 9N MEAN S.D. 10 N MEAN S.D. 11 N MEAN S.D. 12 N MEAN S.D. 13 N MEAN S.D. 1-13 MEAN 12 0.178 0.010 15 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 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 6329-225 3M T-6314.1 PAGE: 2 66 X3-WEEK DIETARY dose ppm MeFOS RBC x i o 6/m l Table 10 of Clinical Hematology Data Summary Males Week. 5 methyl perfluorooctanesulfonamido T'6314) IN HATS HGB G/DL HCT % MCV FL MCH PG MCHC % PLT X103/1*L MEAN S.D. N 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 1173 61.5 10 34.4 .51 10 1151 136.0 10 34.7 .52 10 1038 * 96.9 10 34.5 .45 10 1081 112.7 10 Covance 6329-225 3M T-6314.1 67 Covance 6329-225 3M T-6314.1 Table 10 Summary of Clinical Hematology Data !3-WEEK DIETKEK MMaalreesa W--e-e-k 5 ,, itmu Kj m FTHYL PERFLUOROOCTANESOLFONAMIDO % RATS DOSE ppm MeFOS WBC XlO3/ML N-SEG x i o 3/m d LYMPH x i o 3/m d MONO XlO /Mb EOS IN xio3/ml BASO xioV ml n -s e g % -------- lymph% MONO% EOSIN% baso% MEAN S.D. N MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 9.1 1.96 10 9.1 1.74 10 10.0 2.48 10 10.7 3.51 10 .6 .14 10 .6 .10 10 .5 .15 10 .9 .40 10 7.9 1.86 10 8.0 1.64 10 9.0 2.27 10 9.0 3.17 10 .4 .15 10 .4 .20 10 .4 .13 10 .6 .20 10 .1 .03 10 .1 .05 10 .1 .06 10 .1 .03 10 .0 .00 10 .0 .00 10 .0 .04 10 .0 .05 10 7 2.1 10 6 1.6 10 5 1.4 10 9 3.6 10 87 2.2 10 88 3.5 10 90 1.8 10 84 4.2 10 5 1.3 10 5 1.9 10 4 1.1 10 6 1.3 10 1 .3 10 1 .7 10 1 .3 10 1 .3 10 0 .3 10 0 .0 10 0 .4 10 0 .5 10 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 XI06/Ml* G/DL % FL PG % XIOV/^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 69 DOSE ppm MeFOS WBC x i o 3/m l 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 N-SEG LYMPH x i o V m l X103/i*L MONO EOSIN BASO XlOV^iL X103/aL X103/aL N-SEG% LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 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 .0 N 10 10 10 10 10 10 10 10 10 10 10 30 MEAN 7.3 .5 6.4 .3 .1 .0 8 87 4 1 0 S.D. 2.42 .19 2.24 .19 .05 .00 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 S.D. 2.09 .18 1.96 .27 .04 .03 7 87 5 1 0 3.7 4.5 2.3 .3 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 RBC HGB HCT MCV MCH MCHC PLT ppm MeFOS X106/^L G/DL % FL PG % X103/^I* 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 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 10 1060 73 10 1000 140 10 1011 138 10 Covance 6329-225 3M T-6314.1 71 DOSE ppm MeFOS 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 WBC X103/a(L N-SEG LYMPH X103/^<L X103/m L MONO EOSIN BASO X103/m L X103/m L X103/m L N-SEG% LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% 0 MEAN 6.9 .9 5.4 .5 .1 .0 13 78 7 2 0 S.D. .88 .28 .85 .14 .03 .00 4.0 4.3 1.9 .5 .4 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 .3 N 10 10 10 10 10 10 10 10 10 10 10 30 MEAN 7.7 .9 6.2 .4 .1 .0 13 80 5 1 0 S.D. 2.68 .24 2.57 .14 .05 .00 4.7 5.6 2.1 ,7 .0 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 51 0 S.D. 2.63 .35 2.13 .23 .05 .03 2.8 2.9 1.7 .4 .3 N 10 10 10 10 10 10 10 10 10 10 10 72 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 X106/aL G/DL % FL PG % X103//zL 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 58.1 1.13 10 19.0 .54 10 46.1 1.97 9 57.1 1.70 9 18.7 .63 9 46.2 1.77 10 57.2 1.57 10 18.7 .52 10 43.1 * 1.91 10 56.1 * 1.26 10 18.5 .49 10 32.7 .40 10 32.7 .49 9 32.7 .22 10 33.0 .37 10 1016 103. 10 1073 108 9 980 97 10 1056 110 10 Covance 6329-225 3M T-6314.1 73 DOSE ppm MeFOS WBC X103/^L 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 X103/^L X103/m L MONO EOS IN BASO X103/m L X103/>L X103/m L N-SEG% LYMPH % MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% MEAN S.D. N 4.0 .95 10 .8 3.0 .47 .69 10 10 .2 .12 10 .1 .03 10 .0 .00 10 19 8.5 10 74 8.8 10 5 2.8 10 2 .6 10 0 .4 10 MEAN S.D. N 4.7 1.27 9 .7 3.7 .18 1.27 99 .3 .05 9 .1 .00 9 .0 15 77 .00 5.3 6.4 999 62 0 1.3 8 .0 999 MEAN S.D. N 5.7 1.08 10 1.0 .49 10 4.4 1.10 10 .3 * .10 10 .1 .00 10 .0 .03 10 17 7.6 10 76 8.0 10 5 1.7 10 1 5 10 0 .3 10 100 MEAN S.D. 4.7 2.03 .6 3.8 .28 1.89 .2 .09 .1 .04 .0 14 80 .00 7.0 8.4 4 1.8 20 7 .3 N 10 10 10 10 10 10 10 10 10 10 10 74 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 S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 103 5.7 10 114 14.1 10 106 15.6 10 106 17.5 10 11 1.9 10 11 1.4 10 12 1.7 10 13 * 1.6 10 .6 .07 10 .6 .05 10 .6 .03 10 .6 .07 10 6.9 .39 10 6.9 .23 10 6.6 .22 10 6.7 .29 10 4.7 .23 10 4.7 .19 10 4.7 .14 10 4.7 .21 10 2.2 .26 10 2.1 .14 10 2.0 * .19 10 2.0 * .18 10 .2 .00 10 .2 .00 10 .2 .03 10 .2 .00 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 75 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 Covance 6329-225 3M T-6314.1 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 2.3 10 105 1.6 10 106 1.2 10 105 2.5 10 76 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 108 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 77 * Covance 6329-225 i 3M T-6314.1 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 PA 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 0 .7 10 1 1.1 10 1 .8 10 10.8 .52 10 10.7 .40 10 10.8 .38 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 10 105 1 10 104 1 10 106 2 10 78 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 79 B Covance 6329-225 3M T-6314.1 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 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 80 se DOSE ppm MeFOS Table 13 Summary of Clinical Chemistry Data Hales Week 14 13-WEEK DIETARY TOXICITY STUDY WITH -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 117 13 .8 7.2 4.7 2.5 S.D. 8.2 2.1 .05 .34 .24 .21 N 10 10 10 10 10 10 .2 .05 10 3 MEAN 119 12 .7 7.0 4.7 2.3 S.D. 7.9 2.1 .05 .34 .20 .21 N 10 10 10 10 10 10 .1 .05 10 30 MEAN 113 14 .8 6.8 4.6 2.1 * .2 S.D. 9.7 2.0 .07 .57 .35 .30 .05 N 10 10 10 10 10 10 10 100 MEAN 128 * 15 * .7 7.2 5.2 * 2.0 * .2 S.D. 11.3 1.4 .05 .39 .29 .26 .05 N 10 10 10 10 10 10 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 81 Table 13 Summary of Clinical Chemistry Data Hales Week 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 HG/DL I PHOS HG/DL NA HHOL/L K HHOL/L CL HHOL/L 0 MEAN S.D. N 3 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 3.4 10 109 3.1 10 108 3.0 10 109 3.8 10 Covance 6329-225 3M T-6314.1 82 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 119 12 .8 7.9 5.8 2.1 S.D. 10.6 2.0 .07 .50 .41 .31 N 10 10 10 10 10 10 3 MEAN S.D. N 121 8.0 9 13 2.1 9 .8 7.7 .07 .53 99 5.6 .42 9 2.1 .24 9 30 MEAN 110 14 .8 8.0 5.8 2.2 S.D. 7.0 1.8 .07 .42 .24 .28 N 10 10 10 10 10 10 100 MEAN 110 17 * .8 8.2 6.0 2.1 S.D. 9.2 2.1 .06 .50 .36 .23 N 10 10 10 10 10 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 83 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 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 10 111 3 9 109 2 10 109 3 10 Covance 6329-225 3M T-6314.1 84 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 PCOAO ppm MeFOS IU/G 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 10 2.3 15 9 2.7 15 9 2.0 15 15 * 8.1 15 Covance 6329-225 3M T-6314.1 85 \ if Covance 6329-225 3M T-6314.1 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 DOSE PCOAO ppm MeFOS 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 86 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 1.036 .0179 10 10.6 5.52 10 1.026 .0093 10 13.8 13.29 10 1.026 .0162 10 21.0 16.52 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 87 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 TABLE 15 Summary of Organ Weight Data Week 5 sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL /-O 1 A \ T>T TJ PC -,,,,,,T r^T>o/-von<iMTrcm.irnTJAMTDO ETHANOL (N-MEFOSE Covance 6329-225 3M T-6314.1 PAGE: 1 TABLE INCLUDES: SEX=ALL;GROUP=ALL ;WEEKS=ALL DEATH=1;SUBSET=T SEX DOSE GROUP TERMINAL BODY WT (g) M1 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 335.2 45.6 ---------------- M2 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 340.9 18.5 - - - - ------M. 3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 347.4 26.9 ORGAN WEIGHT (g) ORGAN-TOBODY WT <%) 5 10.7554 2.0653 5 3.1879 0.2295 5 10.9504 0.9661 5 13.1250 1.4559 5 3.2077 0.1326 _ 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 (g) 5 198.2 13.8 5 216.0 15.1 5 214.4 12.5 ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) 5 6.3023 0.5865 5 7.2592 0.4951 5 3.1778 0.1457 _ 5 3.3620 0.0692 5 7.6187 0.7637 __ 5 3.5493 0.2091 89 TABLE 15 Summary of Organ Weight Data Week 5 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFQNAMIDO 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 90 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: 1 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T ;SUBSET=ALL ADRENAL SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 15 505.3 35.7 ORGAN WEIGHT (g) 15 0.0562 0.0092 ORGAN-TO' BODY 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 91 % 4 TABLE 16 Covance 6329-225 3M T-6314.1 Summary of Organ Weight Data Week 14 Sacrifice 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=T; SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT (g) 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: 15 445.8* 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 92 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 SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 15 505.3 35.7 15 2.1771 0.0642 M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 2.1519 0.0910 M3 NUMBER IN GROUP MEAN STANDARD DEV 15 '460.1* 31.8 15 2.1680 0.0768 BRAIN ORGAN-TOBODY WT (%) 15 0.4326 0.0283 ORGAN-TOBRAIN WT RATIO 15 1.0000 0.0000 SEX DOSE GROUP F1 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 0.4480 0.0354 15 1.0000 0.0000 F2 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 0.4731* 0.0323 15 1.0000 0.0000 F3 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 15 270.5 33.3 15 1.9434 0.1049 14 251.3 24.0 14 1.9678 0.0694 15 253.4 17.8 15 2.0183 0.0826 ORGAN-TOBODY WT <%) ORGAN-TOBRAIN WT RATIO 15 0.7256 0.0712 15 1.0000 0.0000 14 0.7891* 0.0733 14 1.0000 0.0000 15 0.7995* 0.0538 15 1.0000 0.0000 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: 4 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=T ;SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT (g) ORGAN WEIGHT (g) BRAIN 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 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 151 . 0 0 0 0 0.0000 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: 5 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL KIDNEY 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 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 M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 3.7300 0.3858 15 0.7744 0.0762 15 1.7358 0.1924 F2 NUMBER IN GROUP MEAN STANDARD DEV M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 15 3.8085 0.3063 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 95 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 96 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 M1 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-TO- BRAIN 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 97 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: 8 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SEX DOSE GROUP M4 TERMINAL BODY WT (3) ORGAN WEIGHT (3) LIVER ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 TERMINAL BODY WT (3) ORGAN WEIGHT (3) ORGAN-TOBODY WT (%) ORGAN-TO- BRAIN 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 98 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 SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 15 505.3 35.7 M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 OVARY ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 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 (g) ORGAN WEIGHT (g) 15 270.5 33.3 15 0.1280 0.0205 14 251.3 24.0 14 0.1225 0.0227 15 253.4 17.8 15 0.1221 0.0215 ORGAN-TOBODY WT (%> ORGAN-TO- BRAIN WT RATIO 15 0.0480 0.0097 15 0.0658 0.0096 14 0.0489 0.0081 14 0.0624 0.0117 15 0.0486 0.0109 15 0.0605 0.0109 99 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 (3) ORGAN WEIGHT (3) 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 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: 11 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 (3) ORGAN WEIGHT (g) 15 505.3 35.7 15 0.8041 0.0904 M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 0.7666 0.1431 M3 NUMBER IN GROUP MEAN STANDARD DEV 15 460.1* 31.8 15 0.7341 0.0802 SPLEEN ORGAN-TOBODY WT (%) 15 0.1592 0.0149 ORGAN-TOBRAIN WT RATIO 15 0.3691 0.0371 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV 15 0.1597 0.0332 15 0.3558 0.0604 F2 NUMBER IN GROUP: MEAN STANDARD DEV 15 0.1602 0.0203 15 0.3390 0.0390 F3 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (3) ORGAN WEIGHT (3) 15 270.5 33.3 15 0.5153 0.1324 14 251.3 24.0 14 0.5235 0.0643 15 253.4 17.8 15 0.5166 0.0506 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 0.1907 0.0408 15 0.2649 0.0644 14 0.2090 0.0239 14 0.2658 0.0290 15 0.2049 0.0251 15 0.2568 0.0306 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- 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 15 0.2037 0.0232 15 0.2294 0.0296 102 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;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL TESTIS 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 ORGAN-TOBODY WT (%) 15 0.6733 0.0559 ORGAN-TOBRAIN WT RATIO 15 1.5579 0.0976 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV M2 NUMBER IN GROUP MEAN STANDARD DEV 15 482.1 27.7 15 3.3852 0.3024 15 0.7028 0.0565 15 1.5752 0.1496 F2 NUMBER IN GROUP MEAN STANDARD DEV M3 NUMBER IN GROUP MEAN STANDARD DEV 15 ' 460.1* 31.8 15 3.4481 0.3067 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 17.8 103 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEfc 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 (3) 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 22.7 104 T A B L E 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) 15 270.5 33.3 15 0.2814 0.0627 14 251.3 24.0 14 0.2951 0.0491 15 253.4 17.8 15 0.2978 0.0627 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 15 0.1053 0.0259 15 0.1451 0.0330 14 0.1176 0.0179 14 0.1499 0.0236 15 0.1174 0.0225 15 0.1476 0.0310 105 r a TABLE 16 Covance 6329-225 3M T-6314.1 Summary of Organ Weight Data Week. 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 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 106 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 THYROID/PARATHYR ORGAN-TO- ORGAN-TOBODY WT BRAIN WT (%) RATIO 15 0.0051 0.0013 15 0.0117 0.0029 SEX DOSE GROUP F1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 15 270.5 33.3 15 0.0203 0.0062 ORGAN-TOBODY WT () ORGAN-TOBRAIN WT RATIO 15 0.0075 0.0024 15 0.0104 0.0029 M2 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 482.1 27.7 15 0.0254 0.0078 15 0.0053 0.0017 15 0.0118 0.0034 F2 NUMBER IN GROUP: MEAN: STANDARD DEV: 14 251.3 24.0 14 0.0180 0.0066 14 0.0072 0.0027 14 0.0092 0.0034 M3 NUMBER IN GROUP: MEAN: STANDARD DEV: '15 460.1* 31.8 15 0.0244 0.0048 15 0.0053 0.0010 15 0.0112 0.0019 F3 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 253.4 17.8 15 0.0190 0,0046 15 0.0075 0.0019 15 0.0094 0.0024 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: 18 TABLE INCLUDES: SEX=ALL;GROUP=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-TO- BRAIN 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 108 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 -- N U M B E R - O F - A N I M A L S - SEX: -MALE---- -- FEMALE-- GROUP: -1- -2- -3- -4- -l- -2- -3- -4- ORGAN AND KEYWORD (S) OR PHRASE NUMBER: 20 20 20 20 20 20 20 20 ** TOP OF LIST ** GENERAL COMMENT (GC) ......... 20 20 20 20 20 20 20 20 BONE MARROW SMEAR TAKEN MALOCCLUSION NO MACROSCOPIC LESIONS TAIL - BENT/MISSING STAINS-PERINEUM/PERIANAL 15 15 15 15 15 14 15 15 1422 0110 8 7 7 6 13 9 11 8 0000 00 01 0010 00 0 0 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 0001 0000 0003 000 0 0002 0001 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 1102 0 000 0100 0000 SPLEEN (SP) .................. ...................... NUMBER EXAMINED: 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 -- 109  TABLE 17 Covance 6329-225 3M T-6314.1 Incidence of Macroscopic Observations 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 -- THYMUS (TH) .................. RED FOCUS(I)/AREA(S) DIFFUSELY RED MOTTLED PITUITARY (PI) ............... LARGE STOMACH, GL (ST) ............. DARK FOCUS(I)/AREA(S) LIGHT FOCUS(I)/AREA(S) LN, MANDIBULAR (MN) .......... DIFFUSELY RED MOTTLED N UMBER -O F -AN IMA L S SEX: --- MALE-- -- ______ -FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 -=" -=" -=" -=- -=- -=- -=- -=- 20 20 20 20 20 20 20 20 NOT REMARKABLE: 17 18 16 18 20 19 19 20 2 131001 0 0 111 010 0 1 0 00 0 0 0 0 20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 20 20 20 19 20 20 20 0000100 0 20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 18 20 18 20 20 19 17 0 102 000 3 0100001 0 20 20 20 20 20 20 20 20 NOT REMARKABLE: 16 18 15 16 20 20 17 20 3243 002 0 1 011001 0 F F E C T E D -- 110 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=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;SUBSET=ALL ORGAN AND KEYWORD(S) OR PHRASE -- N U M B E R - C) F - A N I M A L S - SEX: -MALE---- -- -- -- FEMALE-- GROUP: -1- -2- -3- --4- -l- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 F F E C T E D -- UTERUS (UT) .................. 0 0 0 0 20 20 20 20 NOT REMARKABLE: 0 0 0 0 19 17 19 19 LUMEN FILLED WITH FLUID 00 0 013 1 1 OVARY (OV) ................... ...................... NUMBER EXAMINED: 0 0 0 0 20 20 20 20 NOT REMARKABLE: 0 0 0 0 20 20 19 18 DIFFUSELY RED 00 0 00 0 12 TAIL (TI) .................... 20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 20 20 20 20 19 20 20 LACERATION(S) ** END OF LIST ** 00 0 00 1 0 0 111 TABLE 18 Incidence of Microscopie 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=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) .................... ...... -- N U M B E R - 0 F - ANT M A L 8 SEX: --- MALE-- ___ __ -- 7FM&T.P-- GROUP: -1- NUMBER: 20 20 20 20 20 20 20 20 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 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 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 14 00000001 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 F F E C T E D -- TABLE 18 Incidence of Microscopie 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 A F F E C T E D -- SEX: ------ MALE------ ----- FEMALE- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 LUNG (LU) ........................... -- HEMORRHAGE --INFILTRATE, MACROPHAGE, ALVEOLAR --INFLAMMATION, SUBACUTE -- MINERALIZATION, VASCULAR 15 0 0 15 15 1 0 15 NOT REMARKABLE: 6 0 0 7 12 1 0 12 10000000 40051002 10000001 50 03 2 00 0 TRACHEA (TR) ........................ ............... NUMBER EXAMINED: 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, CENTRILOBULAR --INFILTRATE, LYMPHOHISTIOCYTIC --NECROSIS, COAGULATIVE --NECROSIS, INDIVIDUAL HEPATOCYTE --PIGMENT, HEPATOCELLULAR -- VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL -- VACUOLATION, HEPATOCELLULAR, DIFFUSE ** CONTINUED ON NEXT PAGE ** 00 1 0 1 0 0 0 00000001 0 0 14 15 0 0 7 14 10 15 13 10 10 11 12 00 03 0 0 1 69 5 6 3 64 0002 000 0027000 0022 000 O to0 U1 o <o 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 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) ........................... SEX: N UM B E R -0 F -ANIMA L S --- MALE-- -- F E M A L E -- GROUP: -1- NUMBER: ----20- -- =20-- _2=0_ 20 -=- _2-- 0_ __2_0 _--20_ 20 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 200ooooo 1102oooo 0000o o o 1 10011o o 2 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 F F E C T E D -- TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-634.1 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 ORGAN AND FINDING DESCRIPTION -- N U M B E R - 0 F - A N I M A L S - SEX: -- MALE-- -- -- -FEMALE-- GROUP: -l- -2- -3- -4- -1- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 F F E C T E D -- 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 0 0 00 100 0 THYMUS (TH) ......................... 15 2 4 15 15 2 1 15 NOT REMARKABLE: 9 0 0 6 11 1 0 10 -- HEMORRHAGE -- INVOLUTION 6 2 4 9 411 4 0 0 11 110 2 LN, MESENTERIC (MS) ................. 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 13 15 1 0 15 -- HEMORRHAGE 0 0 02 000 0 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 9007 9006 1 0000000 1 000 0000 1 0 00 0001 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 ** 1 0000000 115 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 N U M B ER - 0 F -ANIMA L S SEX: --- MALE-- -- FEMALE-- GROUP : -1- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 ------ ----- -- ------- ---------------------- -- -- -- ----- ------------ _--_ 20 --=-- 20 --=_ 20 _-- 20 _-- _ __20_ 20 _--_ __20.. ** FROM PREVIOUS PAGE ** PARATHYROID (PT) ............................ 15 0 0 15 15 1 0 15 NOT REMARKABLE: 13 0 0 15 15 1 0 14 -- ONE EXAMINED 10000001 ADRENAL, CORTEX (AC) ........................ 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 14 15 1 0 15 -- INFILTRATE, LYMPHOHISTIOCYTIC 0001 0000 ADRENAL, MEDULLA (MA) ....................... 15 0 0 15 ' 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 AORTA (AO) .................................. 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 PITUITARY (PI) .............................. -- CYST -- HYPERPLASIA STOMACH, GL (ST) .................... ....... --EROSION 15 NOT REMARKABLE: 14 1 0 14 NOT REMARKABLE: 14 0 0 0 15 15 0 0 14 14 001 0 0001 2 15 15 15 1 15 13 15 1020 1 0 15 1 0 15 000 000 1 15 15 1 15 12 003 116 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 STOMACH, NONGL (SU) ............... PANCREAS (PA) ..................... --ATROPHY, ACINAR -- INFILTRATE, LYMPHOHISTIOCYTIC -- INFLAMMATION, CHRONIC-ACTIVE --PIGMENT, BROWN DUODENUM (DU) ..................... JEJUNUM (JE) ...................... ILEUM (IL) ........................ CECUM (CE) ........................ -- N U M B E R - 0 F - A N I M A L S - SEX: -- MALE-- -- -- -- FEMALE-- GROUP: -1- -2- -3- -4- -l- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 20 F F E C T E D -- 14 NOT REMARKABLE: 14 0 15 15 15 0 15 15 15 1 15 15 1 15 15 15 0 0 15 15 1 0 15 NOT REMARKABLE: 11 0 0 13 14 1 0 13 00011001 2 00 01002 1 0020000 2 002000 0 14 0 0 15 15 1 0 15 NOT REMARKABLE: 14 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 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 15 117 TABLE 18 Incidence of Microscopie 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;GROUP=ALL;WEEKS=ALL DEATH=ALL ;FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION COLON (CO) ...................... RECTUM (RE) ..................... -- PARASITISM LN, MANDIBULAR (MN) ............. -- HEMORRHAGE -- HYPERPLASIA, PLASMACYTIC SALIV GL, MANDIB (SG) ........... HARDERIAN GLAND (HG) ............ --INFILTRATE, LYMPHOHISTIOCYTIC AUDITORY SEB GL (AS) ............ -- ONE EXAMINED -- N U M B E R - O F - A N I M A L S SEX: -- MALE---- __ ____--- FEMALE-- GROUP: -1- - NUMBER: 20 20 20 20 20 20 20 20 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: 13 0 0 15 14 1 0 15 20001000 15 2 5 15 15 1 3 15 NOT REMARKABLE: 11 0 0 7 12 1 0 14 42 5 82 031 00 0 0 1 0 0 0 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: 14 0 0 13 15 1 0 14 1002 0001 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 12 11 1 0 13 000 34002 F F E C T E D -- 118 TABLE 18 Incidence of Microscopic Observations Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL -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 - 0 F - A N I M A L S SEX: -1- -2- -3- -4- -1- -2- -3- -420 20 20 20 20 20 20 20 F F E C T E D -- SKIN (SK) .................. -EXUDATE, EPIDERMAL SURFACE -INFLAMMATION, SUBACUTE MAMMARY, FEMALE (MF) NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 14 0 0 15 15 1 0 15 10000000 10000000 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 0002000 0 UTERUS (UT) ........ NUMBER EXAMINED: 0 0 0 0 15 4 1 15 NOT REMARKABLE: 0 0 0 0 14 1 1 10 --DILATATION 00001 30 5 CERVIX <CV) ......................................... NUMBER EXAMINED: 0 0 0 0 15 1 0 15 NOT REMARKABLE: 0 0 0 0 15 1 0 15 OVARY (OV) .......................... NUMBER EXAMINED: 0 0 0 0 15 1 1 15 NOT REMARKABLE: 0 0 0 0 15 1 1 15 119 TABLE 18 incidence of Microscopie 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: 9 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 ** -- NUM BER -0F-AN IMA LS SEX: --- MALE-- ________ __________ -FEMALE-- GROUP: -1- -2- -3- NUMBER: 20 20 20 20 20 20 20 20 0 0 0 0 15 1 0 15 NOT REMARKABLE: 0 0 0 0 15 1 0 15 15 0 0 15 0 0 0 0 NOT REMARKABLE: 3 0 0 9 0 0 0 0 12 0 0 6 0 0 0 0 00010000 15 0 0 15 0 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 0 15 0 0 15 0 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 0 15 0 0 15 0 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 0 00000100 NOT REMARKABLE: 0 0 0 0 0 0 0 0 00000100 00 00 01 00 F F E C T E D -- 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 ORGAN/TISSUE EXAMINED ** TOP OF LIST ** LIVER (LI) .................................... --FIBROSIS, CAPSULAR -- HYPERTROPHY, HEPATOCELLULAR, DIFFUSE -- HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR -- INFILTRATE, LYMPHOHISTIOCYTIC ** CONTINUED ON NEXT PAGE ** N U M B E R - C F - A N I M A L S S E X : --- ---MALE--- -- -- -- FEMALE-- GROUP: -1- -2- -3- -4- -l- -2- -3- -4- NUMBER: 20 20 20 20 20 20 20 F F E C T E D -- 1 1 to 1o 15 15 15 15 15 15 15 -> 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 -> 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 -> 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 -> 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 0.6 121 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 -- N U M B E R - O F - ANI M A L S SEX: --- MALE-- -- -- --- FEMALE-- GROUP: -l- ORGAN/TISSUE EXAMINED ** FROM PREVIOUS PAGE ** NUMBER: 20 20 20 20 20 20 20 20 -- - "=" -SS- -=- -SS- -=- --=- -=- -=- LIVER (LI) .......................................... NUMBER EXAMINED: 15 15 15 15 15 15 15 15 -- NECROSIS, COAGULATIVE -> 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 i> 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 MIDZONAL ** CONTINUED ON NEXT PAGE ** -> 15 15 13 8 15 15 15 13 i> 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 -- 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: 3 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=T -- N UM BER-O F -AN IMA LS - SEX: --- MALE-- _________ --________ FEMALE-*- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED ---------------------------------------------------------------------------------------------- ------------------------- --- ---------------------------------------------- -------------------------------------------------------- NUMBER: -- ------------- ** FROM PREVIOUS PAGE ** LIVER (LI) ..................... --VACUOLATION, HEPATOCELLULAR, DIFFUSE EXAMINED: -> i> 2> TL> MN> _ =20_ 15 15 0 0 15 0.0 20 ~-- 15 15 0 0 15 0.0 20 _ --_ 15 13 2 0 15 0.1 20 -= -- 15 13 0 2 15 0.3 20 " =-- 15 15 0 0 15 0.0 20 _=_ 15 15 0 0 15 0.0 _=20_ 20 ---- -- 15 15 15 15 00 00 15 15 0.0 0.0 -- VACUOLATION, HEPATOCELLULAR, PERIPORTAL "> 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 STOMACH, GL (ST) ............... --EROSION ** END OF LIST ** EXAMINED: 14 2 15 15 15 1 15 15 -> 14 1 15 13 15 1 15 12 i> 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 F F E C T E D -- 123 APPENDIX 1 Protocol Deviations Protocol Protocol Amendment No. 1 Protocol Amendment No. 2 Protocol Amendment No. 3 Covance 6329-225 3M T-6314.1 124 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 P rocedure. 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 of animals at the Week 5 scheduled sacrifice was not documented. 125 Protocol Deviations (Continued) Covance 6329-225 3M T-6314.1 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." 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. C O V A fC ir ^ 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 Laboratoiy: Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Laboratory Study Identification: Proposal No. 90545D Covance 6329-225 Sponsor Project Identification: 3M T-6314.1 127 Covance 6329-225 __________ Page 2 Study 13-W eek Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Purpose To assess the toxicity o f 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 A lternate 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 128 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 of 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 of Pathology Associates International. Liver and serum analyses, data, and report will be audited by the QAU o f 3M Environmental Technology and Safety Services. 129 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 o f the Sponsor Stability Responsibility of the Sponsor Storage Conditions At room temperature C h a ra cteristics Information on synthesis methods, composition, or other characteristics that define the test material is on file with the Sponsor. Reserve (A rchive) 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. D isposition o f 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 130 Animals Covance 6329-225 __________ Page 5 Species Rat Strain Crl:CD(SD) IGS BR Source Charles River Laboratories, Inc., Portage, Michigan Age at Initiation of Treatment Preferably less than 6 weeks of age but not more than 8 weeks of 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 H ousing 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. 131 Covance 6329-225 '______ Page 6 W ater A d libitum . Samples o f the water are routinely analyzed for specified microorganisms and environmental contaminants. The results are on file at Covance-Madisoa Contam inants There are no known contaminants in the diet or water at levels that might interfere with this study. Environm ent Environmental controls for the animal room will be set to maintain 18 to 26C, a relative humidity o f 30 to 70%, and a 12-hour light/12-hour dark cycle. The light/dark cycle may be interrupted to accommodate in-life procedures. Acclim ation At least 1 week Random ization 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 o f the animals o f each sex used will not exceed 2 standard deviations of the mean weight, and the mean body weight for each group of 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. Covance 6329-225 Page 7 G roup Designations and Dietary Levels Number o f Animals Dietary Levels Group 1 (Control)1* 2 (Low) 3 (Mid) 4 (High) Male 20 20 20 20 Female 20 20 20 20 (ppm MeFOS)a 0 3 30 100 a Dose levels are expressed as ppm o f 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 of 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 of 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. 133 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 o f the dose preparations mixed for homogeneity analyses will be collected, divided into three subsamples for extraction and analysis, and analyzed for test material content. All samples will be stored at room temperature until analyzed 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 -30C 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 Confirm ation 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. 134 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. At least once weekly, each animal will be observed (cage will be opened, and the animal will be removed); abnormal findings or 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. O phthalm ic Examinations Ophthalmic examinations will be done for each animal before initiation o f treatment and before the W eek 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). 135 Covance 6329-225 _________ Page 10 Tests 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 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 U rin a ly sis glucose ketones bilirubin blood microscopic examination of sediment Serum Perfluorooctane Sulfonic Acid (PFOS) Analyses Frequency and Number o f Anim als 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. 136 Covance 6329-225 _______Page 11 M ethod of Collection Animals will be fasted overnight; blood (approximately 4 mL) will be collected from a jugular vein. Samples will be collected without anticoagulant. Sam ple H andling 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. Term 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. 137 Covance 6329-225 _________ Page 12 After at least 13 weeks of 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 W eights 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: adrenal (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 M arrow Smear From the femur of 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 of treatm ent, representative samples o f left lateral lobe o f 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: 138 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. Palm itoyl-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 -80C 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 -80 C. 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: 139 Covance 6329-225 _________ Page 14 adrenal(2) aorta brain cecum cervix colon duodenum epididymis (2) esophagus eye (2) femur with bone marrow (articular surface o f 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: 140 Experim ental D esign and M ethods Covance 6329-225 Page 15 R esu lts 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 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 Week 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 of treatment will be analyzed statistically. 141 Covance 6329-225 _________ Page 16 At the end of 1 year after issuance of the audited draft report, if no requested revisions or instructions to finalize have been communicated by the Sponsor, then the audited draft report will be considered 'final' and issued as the final report, signed by the study director, and submitted to the Sponsor. Any modifications or changes to the audited draft report requested 1 year after issuance will be performed at additional cost to the Sponsor. Two copies of 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 o f 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 of 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. 142 PROTOCOL APPROVAL Covance 6329-225 _______ Page 17 3M Date / 143 COVftlici> THE DEVELOPMENT SERVICES 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 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 27,1998 1. Page 3, Proposed Study Tim 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 October 1,1998 2. Page 12, Postm ortem Procedures, Cell Proliferation Tissue Collection and 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. 144 m Covance 6329-225 Protocol Amendment No. 1 ___________ Page 2 AMENDMENT APPROVAL An<ew M. Seacat, PhD Study Monitor 3M Date JQM Date 145 COV/Htfci^ THE DEVELOPMENT SERVICES 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 reparatio n , Dose Analysis, Stability. 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. Covance 6329-225 Protocol Amendment No. 2 ______ ___________ Page 2 Effective December 4,1998 2. Page 13, Postm ortem Procedures, L iver PFO S Analysis, Sentence 1. To clarify collection o f liver sections for PFOS analysis, delete this sentence and replace with the following: At scheduled sacrifices, the remaining portion of 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 Procedures, Cell Proliferation Tissue Collection and Im m unohistochem ical Evaluation, 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. 147 Covance 6329-225 Protocol Amendment No.2 ._________________ Page 3 Effective February 8 ,1 9 9 9 Page 14, Postm ortem Procedures, Histopathology, P arag rap 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 *ach animal in the low-dose group will be embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically. AMENDMENT APPROVAL Andrew M. Seacat, PhD Study Monitor 3M Study Dir^pfor Af Covance Laboratories Inc. 148 COV/VftfC> THE DEVELOPMENT SERVICES COMPANY PROTOCOL AMENDMENT NO. 3 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 of 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 149 Storage Conditions At room temperature Covance 6329-225 Protocol Amendment No. 4 - 3 __________ _______ Page 2 C h a ra cteristics 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 Dat< fi 9* Q % CzsskJ ' ^ APPENDIX 2 Individual Animal Fate Data Individual Clinical Observations Individual Ophthalmic Observations Covance 6329-225 3M T-6314.1 151 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 C95924C95925 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 '1 1 1 1 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 5 152 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 i T T T T T T T T T T T T T T T i i i i i 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 14 153 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: 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 Te r m i n a l s a c r i f i c e 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 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 C96004 C96005 C96006 C96007 C96008 C96009 C96010 C96011 C96012 C96013 C96014 C96015 C96016 C96017 C96018 C96019 C96020 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96031 C96032 C96033 C96034 C96035 C96036 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 2 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 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 i SCHEDULED FIRST INTERIM SACRIFICE i SCHEDULED FIRST INTERIM SACRIFICE i SCHEDULED FIRST INTERIM SACRIFICE i SCHEDULED FIRST INTERIM SACRIFICE i 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 14 155 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 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6 3 2 9 t 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 C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS T 14 APPEARANCE MALOCCLUSION SKIN & PELAGE BLACK SKIN TAIL-DISTAL T 14 DISCHARGE GENITAL RED IN COLOR T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS T 14 'ANIMAL HAS NO SIGNIFICANT FINDINGS T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS T 14 APPEARANCE MALOCCLUSION 29, 36 50, 57, 64, 71 92 71, 78, 85, 92-93 157 i Covance 6329-225 3M T-6314.1 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 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 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: 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, 78 159 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: 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, 92-93 160 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: 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 92-93 161 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: 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 C95951 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 162 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; C' - 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 55 163 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: 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 C95980 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, 36 164 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: 9 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: FI DOSE: 0 PPM DAYS 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, OBSERVED DURING THE DAYS LISTED BELOW; 'C' - COMMENTS LISTED AT END OF OBSERVATIONS 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: 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 C95996 C95997 C95998 C95999 C96000 1 1 1 1 1 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 166 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 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: 12 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 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 & 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 15 168 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: 13 CATEGORY ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER GROUP: F3 DOSE: 30 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C - COMMENTS LISTED AT END OF OBSERVATIONS 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 78 169 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; C1 - 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 170 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; 'C1 - 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, 92-93 171 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: 16 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 C96052 C96053 C96054 C96055 C96056 C96057 C9605B C96059 C96060 1 1 1 1 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 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 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: 1 173 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: 2 174 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: 3 175 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: 4 176 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: 5 177 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 3H T-6314.1 PAGE: 6 178 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 14 Covance 6329-225 3M T-6314.1 PAGE: 7 179 ANIMAL NUMBER C95978 C95979 C95980 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFQNAMIDO 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: 8 180 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: 9 181 ANIMAL NUMBER C95999 C96000 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITHN-METHYL nuorTTinDfW'TuKiRSnT.FONAMIDO 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 Covance 6329-225 3M T-6314.1 PAGE: 10 ANIMAL NUMBER C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 C96016 C96017 C96018 Appendix 2 in d iv id u a l O p h th a lm ic O b s e rv a tio n s Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL T,TMmna.imsilT,FnHAMIDO 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 a n i m a l h a s n o s i g n i f i c a n t 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: 11 183 ANIMAL NUMBER C96019 096020 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 : F2 DOSE: 3 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS Covance 6329-225 3M T-6314.1 PAGE: 12 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 otrutrT.TTnpnnpTAKiP.finrFONAMIDO 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: 13 185 ANIMAL NUMBER C96039 C96040 A p p e n d ix 2 I n d iv id u a l O p h th a lm ic O b s e rv a tio n s W e e k 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL TTrkDrw^o'iiTaRSnT.FONAMIDO ETHANOL (N-MEFOSE w 5 1 A \ TXT t>XTPC CATEGORY KEYWORD QUALIFIER GROUP: F3 DOSE: 30 PPM WEEK 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS C v a n c e 6329-225 3H T-6314.1 PAGE: 14 186 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 Covance 6329-225 3M T-6314.1 PAGE: 15 CATEGORY KEYWORD QUALIFIER GROUP: F4 DOSE: 100 PPM ^ _____________________________________________________________ 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 ________ 187 ANIMAL NUMBER C96059 C96060 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 6329-225 3M T-6314.1 PAGE: 16 188 APPENDIX 3 Individual Body Weight Data (g) Covance 6329-225 3M T-6314.1 A p p e n d ix 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 3 314 321 308 315 303 304 298 316 288 326 304 334 345 302 245 342 324 321 326 317 312 301 306 327 334 294 299 314 WEEK 4 352 362 355 361 341 355 342 364 319 377 337 389 353 349 276 389 370 371 370 360 350 345 346 360 376 324 336 359 WEEK 5 380 392 374 395 376 391 366 399 352 415 361 411 402 377 293 425 400 395 405 397 372 374 374 388 402 350 359 391 WEEK 6 391 407 398 409 386 411 383 417 359 429 462 428 418 427 422 389 389 390 406 418 366 373 404 WEEK 7 420 433 424 436 411 445 406 442 384 457 487 454 438 452 443 411 413 418 427 439 380 397 429 WEEK 8 430 444 437 453 433 461 417 461 395 477 506 474 458 465 464 422 421 437 445 461 401 417 447 Covance 6329-225 311 T-6314.1 PAGE: 1 WEEK 9 WEEK 10 455 473 473 491 459 472 472 485 453 466 485 507 438 455 480 497 417 428 505 533 531 545 502 510 476 485 491 506 481 504 449 466 453 466 465 479 465 479 480 494 421 433 434 454 466 477 190 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL nrT3t?TTTOT3nnPTANFRT1T.FONAMIDO 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 - 3 0 PPM C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956 199 203 230 209 205 204 202 216 219 215 236 205 207 225 198 209 245 248 283 263 261 253 252 265 276 268 297 250 258 279 259 264 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 30'8 332 314 318 WEEK 4 351 374 367 342 353 322 361 408 357 380 341 350 318 325 371 347 355 336 337 358 383 364 392 329 342 374 350 366 WEEK 5 377 398 398 365 381 352 392 436 378 406 363 383 342 347 397 366 385 369 368 380 413 389 416 347 362 404 381 396 WEEK 0 393 413 WEEK 7 418 441 465 395 426 384 398 357 360 408 382 395 386 381 397 428 407 496 412 451 404 418 373 380 429 404 418 410 397 419 457 431 425 448 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 47 5 472 477 528 444 486 433 455 403 400 466 430 462 450 433 457 502 463 554 459 505 442 470 407 408 486 438 477 464 451 467 513 465 489 505 191 Covance 6329-225 I 3M T-6314.1 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL DWDVT.nnBnnCTANESULFONAMIDO ETHANOL {N-MEFOSE, T-6314) TN F A T S PAGE! 3 ANIMAL NUMBER WEEK 1 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 C95962 C95963 C95964 C95965 C95966 C95967 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 4 367 343 323 348 373 321 343 351 313 317 334 349 351 362 336 341 295 320 334 312 330 344 334 342 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 6 411 389 372 399 417 356 389 389 344 360 374 390 386 394 350 376 391 379 382 427 406 392 420 442 381 412 418 371 386 399 422 417 427 361 400 410 398 397 WEEK 8 440 420 401 426 456 397 427 434 382 405 408 437 432 434 WEEK 9 460 438 421 446 476 412 452 447 393 426 423 417 451 453 WEEK 10 474 459 436 452 489 423 463 456 411 438 438 448 463 447 367 380 388 416 432 448 422 439 449 407 419 429 409 429 437 192 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-MET/HYALJ1 TIT CAmG n r m c r n r\T i AMT?GTTT .PONAMTDO ETHANOL (N"MEFOSE 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 156 142 146 169 162 169 146 150 153 172 168 148 158 172 152 165 152 167 173 161 191 175 173 192 195 190 173 171 189 208 193 167 180 194 162 194 176 194 194 180 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 WEE3K 220 213 186 215 213 218 182 182 204 225 214 177 184 217 181 210 192 202 222 206 187 176 190 124 20'5 187 202 217 WEE4K 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 WEE5K 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 WEE6K 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 10 286 256 229 263 270 262 240 250 286 302 288 261 231 276 266 273 250 251 283 322 271 249 244 332 268 243 222 219 251 252 244 260 277 276 252 250 345 275 249 231 226 260 254 248 266 279 193 A p p e n d ix 3 I n d iv id u a l B ody W eig h t D a ta (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL DWPwr.nnRnnCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) 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 - 30 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 3 166 209 203 193 217 214 205 232 224 224 228 193 182 221 210 220 197 188 222 217 197 189 191 195 210 220 227 206 WEEK 4 170 216 246 213 239 245 228 245 257 239 245 222 211 232 219 235 223 206 245 224 206 211 219 220 233 246 240 226 WEEK 5 181 232 250 223 250 260 236 252 271 243 247 224 222 250 234 237 232 213 258 237 223 220 230 230 240 262 245 231 WEEK 6 190 240 266 291 265 264 237 225 249 234 243 235 211 266 240 227 223 238 WEEK 7 200 249 271 287 272 271 239 227 256 243 255 243 228 277 248 236 236 249 WEEK 8 198 249 273 287 275 280 242 234 261 244 252 250 230 280 258 236 241 254 Covance 6329-225 3M T-6314.1 PAGE: 5 WEEK 9 WEEK 10 205 216 265 270 284 295 283 289 252 242 271 255 269 251 232 297 266 245 251 296 281 288 256 249 275 264 273 265 233 300 269 251 251 261 266 194 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERPT.nDROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 1 WEEK 2 GROUP : FEMALE 3 - 30 PPM C96037 C96038 C96039 C96040 158 161 156 140 190 178 181 162 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 140 163 151 169 164 170 160 157 144 150 153 179 152 156 155 155 166 169 141 165 164 184 170 198 182 190 171 188 158 165 163 192 169 174 169 174 196 193 164 188 WEEK 3 202 203 201 170 180 200 188 217 207 211 185 199 163 187 185 208 176 180 172 190 218 224 176 213 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 V 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 WEE9K 1W0EEK 260 263 267 224 223 239 226 268 255 269 219 239 198 216 267 276 270 237 224 239 227 271 263 277 224 241 202 221 222 227 262 264 257 257 218 222 258 262 195 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL BRRVr.nnROOCTANESULFONAMIDO 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 1 481 505 484 501 478 525 468 508 430 550 561 529 493 520 511 0 PPM 492 514 493 516 488 539 481 517 448 579 570 542 505 532 526 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 57 5 444 515 465 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 14 523 542 518 539 509 581 511 543 475 623 601 577 535 567 557 512 527 531 527 510 479 511 524 549 525 585 482 544 483 196 Covance 6329-225 3M T-6314.1 PAGE: 7 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 C95950 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 497 434 478 466 422 451 449 458 475 509 443 488 474 430 461 460 468 481 Appendix 3 Individual Body weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL rir\T5/-\rvr'oiKMT?GnT.T?n>i&MTDn ETHANOL (N-MEFOSE, T 6J14) WEEK 13 WEEK 14 518 435 449 529 466 513 492 463 504 517 495 543 499 500 467 477 513 457 501 485 443 468 472 485 485 524 448 454 534 475 524 502 471 515 413 502 558 516 502 476 481 522 468 511 499 453 482 480 494 500 197 Covance 6329-225 3M T-6314.1 PAGE: 8 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITHJN-METHYL oi?uvT.nnnncTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK WEEK 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 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 473 418 490 490 469 465 331 275 246 299 312 297 272 283 310 341 291 277 267 394 298 263 251 244 298 198 Covance 6329-225 3M T-6314.1 PAGE: 9 Appendix 3 i n d i v i d u a l B o d y W e i g h t D a t a (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL ,,nr TTnnnivmAMccnT.pnMaMTnn ETHANOL (N-MEFOSE, T 6314) 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 14 269 274 292 305 231 292 303 306 321 267 262 292 277 283 275 255 323 295 265 262 275 283 304 284 251 199 Covance 6329-225 3M T-6314.1 PAGE: 10 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS WEEK 12 - 100 PPM 222 231 242 246 232 239 276 282 269 271 279 283 224 226 248 243 203 207 225 228 228 224 270 267 256 262 227 219 267 269 WEEK 13 234 249 242 283 273 284 227 247 208 233 226 276 269 228 275 WEEK 14 236 247 239 287 280 290 231 259 213 239 229 279 271 232 271 200 Covance 6329-225 3M T-6314.1 APPENDIX 4 Individual Food Consumption Data (g) Individual Test Material Consumption Data (mg/kg/day) 201 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 C95907 C95908 C95909 C95910 C95911 C95912 C95913 C95914 C95915 C95916 C95917 C95918 C95919 C95920 165 172 160 176 164 161 156 177 152 175 172 187 181 164 136 176 187 168 178 164 168 174 173 182 165 166 158 183 151 179 165 191 179 172 SPILLED 188 185 181 207 168 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 WEEK 4 171 183 179 190 176 187 191 202 175 182 182 199 169 174 192 202 154 SPILLED 191 198 162 172 194 198 169 174 180 187 163 142 191 192 184 185 186 187 231 SPILLED 179 190 168 175 175 179 SPILLED 167 165 188 175 179 178 184 214 168 170 202 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 8 179 181 181 197 187 187 190 203 182 202 181 208 182 SPILLED SPILLED 199 195 188 180 177 167 197 199 192 170 194 164 200 165 193 194 187 180 233 185 176 175 185 186 206 171 172 201 190 189 182 242 189 185 176 186 186 211 177 177 206 186 186 181 SPILLED 184 SPILLED 183 191 186 215 167 175 201 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 99 167 165 173 170 197 189 202 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: MALE 2 - 3 PPM C95929 C95930 C95931 C95932 C95933 C95934 C95935 C95936 C95937 C95938 C95939 C95940 175 177 155 160 165 156 183 171 163 177 163 165 186 194 SPILLED 165 172 161 195 189 172 189 174 171 GROUP : MALE 3 PPM C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956 154 156 178 174 168 169 151 166 172 168 181 155 178 184 194 208 159 162 184 179 184 168 161 179 186 180 185 161 186 197 197 SPILLED Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL TiriDnnr'traKivRnT.pnNAMIDO ETHANOL (N-MEFOSE, T-6314) WEEK 3 WEEK 4 WEEK 5 WEEK 6 WEEK 7 191 218 215 166 176 164 197 203 175 197 187 176 158 161 190 183 191 180 166 200 191 189 193 167 192 202 200 214 195 195 SPILLED 173 172 169 197 197 178 204 191 184 166 166 197 186 193 189 171 188 201 188 192 174 187 216 210 228 191 176 192 184 186 199 179 152 152 162 164 179 173 152 176 181 168 SPILL 237 234 208 190 191 184 194 185 178 162 170 186 189 198 186 168 185 207 200 194 186 197 184 187 159 145 189 180 197 184 162 183 209 191 259 246 WEEK 8 SPILLED 186 188 SPILLED 199 180 185 153 153 183 178 187 189 155 185 204 189 SPILLED Covance 6329-225 3M T-6314.1 PAGE: 2 WEEK 9 WEEK 10 235 227 186 170 189 198 197 168 189 145 158 185 169 187 178 157 182 200 190 187 195 202 169 188 145 166 178 168 183 175 149 181 199 180 226 223 203 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PFRFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: MALE 3 - 3 0 PPM C95957 C95958 C95959 C95960 166 168 163 168 179 175 176 181 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 4 189 182 193 200 194 167 171 194 172 173 179 197 180 187 152 172 167 172 173 165 177 170 176 177 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 10 176 167 188 180 188 181 167 164 188 180 171 167 183 176 179 175 169 162 180 183 179 177 158 191 178 177 174 173 155 146 184 176 180 180 171 170 180 174 204 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 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 GROUP : FEMALE 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 SPILLED 103 106 169 125 SPILLED 119 148 PPM 150 143 139 130 128 152 123 114 134 147 126 101 108 133 SPILLED 126 107 112 144 145 1 PPM 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 WEE9K 104 119 SPILLED 141 136 132 132 125 SPILLED 147 109 SPILLED 119 163 SPILLED SPILLED 113 109 144 129 SPILLED 133 135 WE1E0K 137 114 130 131 129 128 119 126 244 147 109 SPILLED 113 181 SPILLED 107 106 109 166 120 SPILLED 136 136 205 Covance 6329-225 B 3M T-6314.1 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) i n r a t s 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 131 124 122 136 140 131 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 167 144 132 130 153 158 137 126 140 149 131 129 135 SPILLED 188 132 159 138 163 128 137 139 136 122 week 4 week 5 week 6 WEEK 7 WEEK 8 108 137 153 128 150 150 137 127 151 SPILLED 137 126 99 124 131 157 SPILLED 147 126 147 141 131 140 SPILLED 145 120 171 SPILLED 128 141 SPILLED 149 128 125 139 130 137 SPILLED 146 125 142 150 137 134 135 SPILLED SPILLED 135 135 139 SPILLED 131 133 164 142 118 134 SPILLED 113 117 120 SPILLED SPILLED 120 115 130 SPILLED 152 141 154 132 137 155 181 128 SPILLED 139 159 SPILLED 140 131 SPILLED 129 SPILLED SPILLED 138 SPILLED 146 SPILLED 127 127 138 131 134 SPILLED SPILLED 137 158 130 138 WEEK 9 119 151 WEEK 10 104 136 NOT TAKEN 138 139 142 117 138 146 143 114 SPILLED 131 131 121 139 SPILLED 164 139 SPILLED 133 117 127 130 121 127 171 162 134 220 130 SPILLED SPILLED Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL UDPT.nnnnnfTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RA S Covance 6329-225 3M T-6314.1 PAGE: 6 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: C96037 C96038 C96039 C96040 GROUP: C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96051 C96052 C96053 C96054 C96055 C96056 C96057 C96058 C96059 C96060 FEMALE 3 - 3 0 PPM 130 120 185 SPILLED 127 161 SPILLED SPILLED FEMALE 4 - 100 PPM 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 125 107 109 142 148 136 106 110 105 117 111 137 125 124 115 ' WEEK 7 WEEK 8 WEEK 9 w e1e0k 129 SPILLED SPILLED SPILLED 136 SPILLED 159 SPILLED 117 106 105 129 142 SPILLED 104 102 98 114 113 109 102 141 140 151 109 111 106 109 127 SPILLED SPILLED 225 111 104 104 135 146 149 103 114 108 111 122 149 SPILLED SPILLED 110 96 106 128 140 125 100 115 102 108 103 132 129 125 125 107 133 124 SPILLED 121 101 124 121 SPILLED 123 102 135 127 SPILLED 115 207 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 167 171 180 184 176 182 216 213 244 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 208 174 188 184 190 158 177 194 221 177 179 154 195 168 204 176 185 188 199 153 176 197 207 184 161 140 199 168 WEEK 13 172 180 179 198 177 190 SPILLED 194 157 208 182 SPILLED 173 241 181 203 171 169 184 193 154 167 178 189 177 172 181 188 166 208 Covance 6329-225 3M T-6314.1 PAGE: 7 Appendix 4 I n d iv i d u a l F o o d C o n su m p tio n D a ta (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 184 184 GROUP: MALE 3 - 3 0 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 177 159 182 177 163 175 177 197 169 178 164 183 178 169 172 177 199 170 week 13 139 181 171 158 188 167 138 182 7 188 207 165 173 178 156 178 157 175 178 168 164 166 175 170 209 Covance 6329-225 3M T-6314.1 PAGE: 8 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 I2 GROUP: MALE 4 - 1 0 0 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 HO 112 HI 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 101 105 107 137 210 Covance 6329-225 3M T-6314.1 PAGE: 9 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL DwuwT.nnRnnCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) ANIMAL NUMBER WEEK 11 WEEK 12 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 GROUP : FEMALE 3 - 30 PPM C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96036 C96037 C96038 C96039 C96040 195 132 125 123 125 SPILLED 193 116 SPILLED 122 SPILLED 128 139 197 SPILLED 127 121 121 123 107 250 183 120 177 123 129 128 134 172 174 WEEK 13 113 SPILLED 136 126 SPILLED 130 97 SPILLED 150 113 125 126 121 118 115 220 148 124 SPILLED 125 212 134 130 162 SPILLED 211 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 PAGES 11 212 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 0.4 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 00.. 23 0.3 0.3 0.3 0.3 0.3 0.3 SPILLED 0.3 0.3 0.3 0.3 00.. 23 0.3 0.3 0.3 GROUP: C95941 C95942 C95943 C95944 C95945 C95946 C95947 C9594B MALE 3 - 3 0 3.0 3.0 3.0 3.2 3.1 3.2 2.9 3.0 PPM 22 .. 66 2.6 2.7 22.. 67 22.. 65 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 00000.....22222 0.2 000... 222 0.2 SPILL0E. 2D 00.. 22 0.2 00.. 22 000... 222 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 00.. 22 00.. 22 SPILLED 00 .. 22 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 000 ... 222 0.2 000... 222 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 00..22 0.2 00..22 0.2 00..22 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 00.. 22 0.2 00 .. 22 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.2 0.2 0.2 0.2 0.2 00.. 22 0.2 0.1 0.2 0.2 00.. 22 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.2 0.2 0.2 0.2 1.9 1.8 1.7 1.9 2.0 2.0 1.7 1.9 1.9 2.0 1.9 2.1 2.1 2.0 1.9 1.9 1.8 1.7 1.8 1.9 2.0 1.9 1.7 1.8 1.7 1.7 1.7 1.8 1.8 1.9 1.6 1.8 1.5 1.7 1.7 1.7 1.7 1.7 1.5 1.7 1.5 1.7 1.5 1.6 1.6 1.6 1.4 1.6 213 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 - 30 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 5.3 214 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 6329r225 3M T-6314.1 PAGE: 3 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP: MALE 4 - 1 0 0 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 C96009 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 67 WEEK 8 WEEK 9 WEEK 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 0.2 215 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: 4 ANIMAL NUMBER WEEK i 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 6.7 216 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: 5 ANIMAL NUMBER WEEK 1 WEEK 2 GROUP : FEMALE 4 - 100 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 6 WEEK 7 WEEK 8 WEEK 9 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 6.2 217  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 ANIMAL NUMBER WEEK 11 WEEK 12 WEEK 13 GROUP: C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95931 C95932 C95933 C95934 C95935 C95936 C95937 C95938 C95939 C95940 MALE 2 - 3 0.2 000...222 0.2 0.1 0.2 0.2 00.. 22 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.1 0.2 0.2 0.2 PPM 00 .. 22 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 00.. 22 0.1 0.1 0.1 0.1 d.i 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 1.5 218 Covance 6329-225 3M T-6314.1 PAGE: 6 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 56.. 04 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 5.1 219 Covance 6329-225 3M T-6314.1 PAGE : 7 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 - 100 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: 8 220 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 7.1 221 Covance 6329-225 3M T-634.1 PAGE: 9 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 C96055 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: 10 222 APPENDIX 5 Individual Clinical Hematology Data Individual Clinical Chemistry Data Individual Clinical Urinalysis Data Covance 6329-225 3M T-6314.1 223 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 X106/a*L G/DL t FL PG % XIOV^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. 10 1136 1297 1400 1177 1108 1172 1166 1143 917 993 1151 136. 10 Covance 6329-225 3M T-6314.1 224 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 HOT MCV MCH MCHC PLT NUMBER XIOV^L G/DL % FL PG % XIOV/^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 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 96.9 10 1141 1097 1177 986 1166 948 1001 1296 1032 970 1081 112.7 10 Covance 6329-225 3M T-6314.1 225 I ANIMAL NUMBER 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 WBC X103/m 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 X103/aL XIOV^L MONO xioV^l EOSIN x i o 3/^l BASO N-SEG% X103/^L LYMPH % MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% Dose Level : 0 Dosage Unit: ppm MeFOS 8.6 .5 7.7 .4 .1 .0 6 89 4 1 0 9.7 .6 8.6 .4 .0 .0 6 89 5 0 0 6.7 .8 5.7 .2 .1 .0 11 85 3 1 0 11.9 .4 10.7 .7 .1 .0 3 90 6 1 0 8.4 .6 7.3 .3 .1 .0 8 87 4 1 0 6.9 .5 6.0 .3 .1 .0 7 87 4 1 0 8.1 .5 7.1 .4 .1 .0 6 88 5 1 1 12.7 .8 11.4 .4 .1 .0 6 90 3 1 0 8.1 .7 6.8 .5 .1 .0 9 84 6 1 0 9.5 .7 8.1 .6 .1 .0 7 85 7 1 0 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 10 10 10 10 10 10 10 10 10 10 10 Dose Level : 3 Dosage Unit: ppm MeFOS 8.4 .5 7.5 .4 .1 .0 6 88 4 1 0 7.9 .6 6.6 .5 .2 .0 7 84 6 3 0 9.3 .6 8.2 .5 .1 .0 6 88 5 1 0 8.5 .6 7.2 .5 .1 .0 8 85 6 1 0 9.8 .5 8.9 .3 .1 .0 5 91 3 1 0 12.6 .7 10.9 .9 .1 .0 5 86 7 1 0 8.6 .7 7.2 .5 .1 .0 8 84 6 2 0 7.3 .4 6.8 .1 .0 .0 5 93 1 1 0 7.4 .7 6.2 .4 .1 .0 9 84 6 1 0 11.5 .5 10.6 .4 .1 .0 4 92 3 1 0 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 10 10 10 10 10 10 10 10 10 10 10 226 ANIMAL NUMBER WBC X103/aL 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/m L x i o V ^ l MONO EOS IN X103/m L X103/^L BASO N-SEG% X103/m 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 1 0 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 89 411 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 14.4 .5 13.2 .6 .1 .1 3 92 4 0 1 C95962 10.2 1.0 8.4 .7 .1 .1 10 82 7 11 C95963 10.1 .5 8.9 .6 .1 .0 5 88 61 0 C95964 9.8 .8 8.5 .4 .1 .0 8 86 4 1 0 C95965 6.4 .7 5.2 .4 .1 .0 11 82 61 0 C95966 14.0 1.4 11.6 .8 .2 .0 10 83 610 C95967 4.2 .5 3.3 .3 .1 .0 12 79 8 1 0 C95968 14.7 1.1 12.7 .7 .1 .1 7 86 511 C95969 13.4 1.5 10.8 .9 .1 .0 12 80 7 10 C95970 9.8 1.4 7.8 .4 .1 .0 15 79 5 1 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 .5 10 10 10 10 10 10 10 10 10 10 10 227 B Covance 6329-225 Appendix 5 3M T-6314.1 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 ------- 228 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 Dose Level: 100 Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 229 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 X10V/iL G/DL % FL PG % x i o 3a <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 Unit : 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 1230 1254 1094 1137 1012 1085 913 1190 1056 1171 1114 104. 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 1297 1181 1107 1267 1139 1166 1106 1303 1083 1129 1178 82. 10 Covance 6329-225 3M T-6314.1 230 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//dj G/DL % FL PG % X103/a<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 3H T-6314.1 231 ANIMAL NUMBER 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 WBC X103/m L 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 X103/a<L X103/^L MONO EOS IN BASO N-SEGt X 1 0 X 1 0 3/a<L X103/*<L LYMPH% MONO% EOSINt Covance 6329-225 3M T-6314.1 BASO Dose Level : 0 Dosage Unit: ppm MeFOS 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 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 Dose Level : 3 Dosage Unit: ppm MeFOS 5.7 .5 5.1 .1 .1 .0 9 88 1 1 0 3.5 .3 3.0 .1 .0 .0 9 86 4 1 0 7.6 .7 6.3 .4 .2 .0 10 83 5 2 0 7.2 .3 6.5 .4 .1 .0 4 90 5 1 0 11.1 .3 10.6 .2 .0 .0 2 96 1 0 0 5.8 .4 5.0 .3 .0 .0 6 88 5 1 0 10.4 .4 9.7 .3 .1 .0 4 93 3 1 0 7.0 .4 6.2 .3 .1 .0 5 89 5 1 0 7.9 .8 6.6 .3 .1 .0 10 84 42 0 7.4 .8 6.4 .1 .0 .0 11 86 2 0 0 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 10 232 ANIMAL NUMBER WBC X103/m L 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 X103/aL X103//iL MONO EOSIN x i o 3/m l x i o 3/m l BASO N--SEG% x i o 3/^l LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% Group : 3 Dose Level : 30 Dosage Uni t : ppm MeFOS C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 7.7 6.2 5.1 5.9 5.7 9.7 10.9 6.7 4.4 11.1 .3 7.0 .3 5.6 .8 3.8 .4 5.2 .3 5.2 .5 8.8 .6 9.6 .4 5.9 .7 3.6 .7 9.6 .2 .1 .0 4 92 .3 .0 .0 4 90 .4 .1 .0 16 74 .2 .1 .0 7 88 .2 .1 .0 5 90 .2 .1 .0 6 91 .7 .1 .0 5 88 .3 .0 .0 6 88 .1 .0 .0 15 81 .6 .1 .0 7 87 3 10 4 10 820 310 310 2 10 610 510 310 510 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 10 10 10 10 10 10 10 10 10 10 10 Group : 4 Dose Level : 100 Dosage Unit: ppm MeFOS C96041 10.2 .3 9.6 .3 .1 .0 3 94 2 1 0 C96042 6.7 .4 5.9 .3 .1 .0 7 88 4 1 0 C96043 8.9 .5 7.9 .4 .1 .0 6 88 5 1 0 C96044 6.6 .8 5.4 .3 .1 .0 12 82 4 2 0 C96045 '10.8 .4 9.1 1.1 .1 .1 4 84 10 1 1 C96046 5.7 .2 5.2 .2 .0 .0 3 92 4 1 0 C96047 ' 6.6 .4 5.8 .3 .1 .0 6 88 4 1 0 C96048 5.7 .7 4.8 .2 .1 .0 12 84 3 1 0 C96049 7.3 .4 6.7 .2 .0 .0 5 91 3 1 0 C96050 4.2 .5 3.4 .3 .1 .0 12 80 7 1 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 10 10 10 10 10 10 10 10 10 10 10 233 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 C96010 Dose Level: 0 Dose Level: 3 Dosage Unit : ppm MeFOS Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 234 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-6314.1 235 M 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 X106/^L G/DL % FL PG % x i o 3/m 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-6314.1 236 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 X106//jL G/DL % FL PG % x i o 3/m 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 Uni t: 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 140.3 10 957 992 1153 1014 1104 907 1306 902 878 897 1011 138.4 10 Covance 6329-225 3M T-6314.1 237 ANIMAL NUMBER 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 WBC XloV^iL 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/^L XIOV^L MONO EOSIN BASO N-SEG% X103/AiL X103/a(L X103/m L LYMPH% MONO% EOSIN% Covance 6329-225 3M T-6314.1 BASO% Dose Level : 0 Dosage Unit: ppm MeFOS 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 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 Dose Level : 3 Dosage Unit: ppm MeFOS 4.8 .8 3.6 .3 .1 .0 16 76 62 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 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 10 238 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 X103/^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 XIOV^L X103/^L MONO EOSIN x i o V m l X103/^L BASO N -SEG% X103/aL 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 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 10 10 10 10 10 10 10 10 10 10 10 239 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 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-6314.1 241 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 X106/^L G/DL % FL PG % x i o V m 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 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-6314.1 242 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 X106/aiL G/DL % FL PG % X103/^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 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-6314.1 243 Ml ANIMAL NUMBER 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 WBC x i o 3/m 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 X103/m L X103/>L MONO EOSIN X103/>/L XlOV^tL BASQ N-SEG% X103///L LYMPH% MONO% EOSIN% Covance 6329-225 3m T-6314.1 BASO% Dose Level : 0 Dosage Unit: ppm MeFOS 4.2 1.0 3.1 .0 .1 .0 24 74 1 2 o 2.3 .3 1.9 .1 .0 .0 12 82 4 2 o 4.9 1.9 2.6 .3 .1 .0 39 53 7 1 o 4.8 .7 4.0 .0 .1 .0 15 82 0 2 o 3.6 .4 2.9 .2 .1 .0 11 81 6 2 o 5.6 1.1 4.2 .2 .1 .0 19 75 4 2 o 3.1 .5 2.4 .1 .1 .0 15 78 4 2 o 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 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 10 10 10 10 10 10 10 10 10 10 10 Dose Level : 3 Dosage Unit: ppm MeFOS 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 o 6.7 .5 5.8 .3 .1 .0 8 86 4 i 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 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 99999999999 244 ANIMAL NUMBER WBC X103///L A p p e n d ix 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 XloViiL X103/m L MONO EOSIN XIOVk L XIO/AiL BASQ N-SEG% X10 /L LYMPH% MONO% C o v an ce 6 3 29-225 3M T - 6 3 1 4 . 1 EOSIN% BASO% 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 C9606Q MEAN S.D. N Dose Level: 30 6.9 .6 5.1 .8 5.1 .8 4.9 .9 4.5 .5 6.6 1.9 5.4 .9 7.8 .6 6.0 1.8 4.8 .8 5.7 1.08 10 1.0 .49 10 Dose Level : 100 2.9 .4 3.6 .6 9.7 1.0 6.4 .6 3.9 .3 4.0 1.1 4.7 .4 3.8 .9 3.0 .4 4.8 .5 4.7 2.03 10 .6 .28 10 Dosage Unit: ppm MeFOS 6.1 .1 .1 3.9 .3 .1 3.8 .4 .1 3.5 .3 .1 3.8 .2 .1 4.2 .3 .1 4.1 .4 .1 6.7 .4 .1 3.9 .2 .1 3.6 .3 .1 4.4 .3 .1 1.10 .10 .00 10 10 10 Dosage Unit: ppm MeFOS 2.3 .1 .0 2.8 .2 .1 8.4 .2 .1 5.5 .3 .1 3.4 .0 .1 2.6 .2 .1 4.1 .2 .0 2.6 .3 .1 2.5 .1 .1 4.0 .2 .1 3.8 .2 .1 1.89 .09 .04 10 10 10 .0 .0 .0 .0 .0 .0 .0 .1 .0 .0 .0 .03 10 .0 .0 .0 .0 .0 .0 .0 .0 .0 .0 .0 .00 10 8 15 16 19 10 29 16 7 29 17 17 7.6 10 14 17 10 9 8 28 7 24 13 11 14 7.0 10 89 77 74 72 83 65 75 86 65 75 76 8.0 10 81 76 86 85 89 65 88 67 82 84 80 8.4 10 2 6 8 6 4 5 7 5 4 6 5 1.7 10 4 4 2 4 0 5 4 7 3 4 4 1.8 10 1 1 2 2 1 1 1 2 1 1 i .5 10 1 2 1 1 1 2 1 3 2 2 2 .7 10 0 0 0 0 0 0 0 1 0 0 0 10 0 0 0 1 0 0 0 0 0 0 0 10 245 A p p e n d ix 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 - 6 3 1 4 .1 246. A p p e n d ix 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 Dose Level: 30 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 - - Group: 4 Dose Level: 100 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 - - Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS C o v an ce 6 3 2 9 -2 2 5 3M T - 6 3 1 4 .1 247 K C ovance 6 3 29-225 A p p e n d ix 5 3M T - 6 3 1 4 .1 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 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 Group: 1 Dose Level: 0 Dosage Uni t : 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 Unit: ppm MeFOS C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 116 10 109 11 117 10 107 14 148 9 108 12 104 12 103 10 103 10 127 11 .7 7.1 5.1 2.0 .6 6.5 4.5 2.0 .6 7.0 4.8 2.2 .7 6.6 4.5 2.1 .7 7.1 4.7 2.4 .6 7.0 4.7 2.3 .6 6.9 4.7 2.2 .6 6.9 4.9 2.0 .6 6.6 4.6 2.0 .7 7.1 4.9 2.2 .2 50 44 .2 51 51 .2 54 30 .2 88 44 .2 62 50 .2 50 53 .2 59 75 .2 45 92 .2 60 69 .2 63 38 MEAN S.D. N 114 11 .6 6.9 4.7 2.1 .2 58 55 14.1 1.4 .05 .23 .19 .14 .00 12.1 18.8 10 10 10 10 10 10 10 10 10 *- '" I ' M 248 ANIMAL NUMBER A p p e n d ix 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 C o v an ce 6329-225 3M T - 6 3 1 4 . 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 10.4 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 152 17 .7 6.4 4.4 2.0 .2 26 12 90 11 .6 6.6 4.7 1.9 .2 25 27 97 12 .7 6.8 4.8 2.0 .2 60 45 102 13 .6 6.4 4.8 1.6 .2 64 29 94 12 .6 7.0 4.9 2.1 .2 41 25 110 13 .5 6.3 4.4 1.9 .2 34 16 99 13 .6 6.9 4.8 2.1 .2 55 24 111 12 .6 7.1 4.8 2.3 .2 54 35 105 13 .5 6.5 4.5 2.0 .2 35 17 98 13 .6 7.0 5.0 2.0 .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 9.9 10 10 10 10 10 10 10 10 10 249 ANIMAL NUMBER A p p e n d ix 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 0 11.3 1 11.0 0 10.4 0 10.4 0 11.6 1 10.5 0 11.0 0 10.7 0 10.8 10.2 9.9 9.0 10.5 8.5 9.6 8.9 9.7 9.3 9.3 0 .5 10 10.9 .47 10 9.5 .61 10 Dosage Unit: ppm MeFOS 0 11.1 1 10.6 0 10.7 1 11.0 0 10.7 0 10.9 0 11.1 0 10.9 0 10.7 1 10.6 11.1 9.0 10.3 10.3 9.0 9.5 9.6 10.5 9.7 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..3 10 108 102 105 106 105 104 104 105 103 105 105 1. 6 10 C ovance 6 3 2 9 -2 2 5 3M T - 6 3 1 4 . 1 ANIMAL NUMBER A p p e n d ix 5 Individual Clinical Chemistry Data Hales 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 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 1.2 10 103 107 106 109 104 104 108 103 102 102 105 2.5 10 C o v an ce 6 329-225 3M T - 6 3 1 4 . 1 251 ANIMAL NUMBER 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 A p p e n d ix 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 Dose Level : 0 Dosage Unit: ppm MeFOS 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 42 108 12 .7 7.4 5.3 2.1 .2 68 30 9.2 1.,2 .03 .31 .21 .24 .05 11..9 8 10 10 10 10 10 10 10 10 10 Dose Level : 3 Dosage Uni t: ppm MeFOS 99 9 .6 7.3 5.4 1.9 .2 53 20 99 11 .7 7.6 5.8 1.8 .2 54 19 107 10 .7 7.0 4.9 2.1 .2 87 40 95 9 .6 6.9 5.0 1.9 .2 70 43 115 14 .7 7.4 5.0 2.4 .2 81 25 116 14 .7 6.9 4.8 2.1 .2 68 24 103 10 .7 7.5 5.3 2.2 .2 54 19 116 11 .7 8.5 6.0 2.5 .2 75 36 105 14 .7 7.2 5.2 2.0 .2 78 22 121 13 .7 7.2 5.4 1.8 .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 10 10 10 10 10 10 10 10 10 252 ANIMAL NUMBER A p p e n d ix 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 C ovance 6329 -2 2 5 3M T - 6 3 1 4 . 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. 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 10 10 10 253 ANIMAL NUMBER A p p e n d ix 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 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 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 Unit: 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 C o vance 6 3 2 9 -2 2 5 3M T - 6 3 1 4 .1 254 ANIMAL NUMBER A p p e n d ix 5 Individual Clinical Chemistry Data Females week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESUIiFONAMIDO 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 Unit: 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. B .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 C ovance 63 2 9 -2 2 5 3H T - 6 3 1 4 .1 255 A p p e n d ix 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 C o v an ce 6 3 2 9-225 311 t - 6 3 1 4 . 1 256 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 : 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-6314.1 257 m 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 6 9 3 7 9 7 2.5 5 Dose Level 6 3 9 3 2 5 2.9 5 Dose Level 7 6 5 5 13 7 3.3 5 Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS C o v an ce 6 3 2 9 -2 2 5 3M T - 6 3 1 4 .1 258 Appendix 5 Individual Clinical Chemistry Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, 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-6314.1 259 ANIMAL NUMBER 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 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: 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 Unit: ppi 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 22.2 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 23.3 10 10 10 260 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 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 C95947 C95948 C95949 C95950 C95958 C95960 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 MEAN S.D. N 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 Group: 4 Dose Level: 100 Dosage Unit: ppm MeFOS C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 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 MEAN S.D. N 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 10 261  4 Covance 6329-225 Appendix 5 3 M t -6314.1 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 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 3 3 1 0 3 3 3 2 0 1 2 1.3 10 Dosage 2 2 2 3 3 2 3 3 3 1 2 .7 10 it: ppm MeFOS 11.3 10.6 10.8 10.3 9.9 11.3 10.2 11.2 11.0 10.6 7.8 6.0 7.6 7.0 6.2 6.2 6.2 6.2 6.4 6.2 10.7 .49 10 6.6 .65 10 it: ppm MeFOS 10.3 10.8 10.3 10.2 10.6 10.9 10.8 10.3 10.7 10.7 6.7 6.7 6.7 6.2 6.1 6.9 6.5 6.1 6.4 6.7 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 10 262 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 C o v an ce 6 3 2 9 -2 2 5 3M T - 6 3 4 . 1 263 ANIMAL NUMBER 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 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 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 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 21 999 264 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: 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 : 30 109 13 111 16 97 13 105 12 116 13 122 12 103 13 113 17 113 16 111 13 110 7.0 10 14 1.8 10 Dose Level : 100 100 15 116 14 125 15 116 18 109 17 120 18 111 18 104 20 95 19 109 14 110 9.2 10 17 2.1 10 Dosage Units ppm MeFOS .8 7.7 5.6 .9 7.8 5.9 .8 8.3 6.1 .7 7.8 5.6 .9 8.8 6.0 .7 7.6 5.5 .8 7.6 5.7 .8 7.7 5.7 .9 8.2 5.7 .8 8.5 6.2 .8 8.0 5.8 .07 .42 .24 10 10 10 Dosage Unit: ppm MeFOS .8 9.0 6.6 .9 8.6 6.4 .8 7.6 5.6 .9 7.8 5.6 .8 8.1 6.2 .9 8.6 6.1 .8 7.7 5.9 .7 7.9 5.7 .8 8.7 6.4 .8 7.8 5.9 .8 8.2 6.0 .06 .50 .36 10 10 10 2.1 1.9 2.2 2.2 2.8 2.1 1.9 2.0 2.5 2.3 2.2 .28 10 2.4 2.2 2.0 2.2 1.9 2.5 1.8 2.2 2.3 1.9 2.1 .23 10 .2 57 35 .2 58 30 .2 74 29 .2 66 36 .2 75 26 .2 59 32 .2 78 69 .2 78 26 .2 74 44 .1 86 37 .2 70 36 .03 9.9 12.7 10 10 10 .2 84 32 .2 65 29 .2 45 26 .2 56 23 .2 50 18 .2 30 21 .2 35 25 .2 34 22 .2 42 22 .2 71 28 .2 51 25 .00 17.7 4.2 10 10 10 265 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 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 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 9 Covance 6329-225 3M T-6314.1 266 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 : 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 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-6314.1 267 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 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: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 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-6314.1 269 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: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95956 C95957 C95958 C95959 C95960 MEAN S.D. N Dose Level: 30 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-6314.1 270 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-6314.1 271 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: 0 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 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-6314.1 273 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-6314.1 274 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 Lei 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-6314.1 275 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 Unit: ppm MeFOS 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 Unit: ppm MeFOS 7.5 7.0 7.0 7.0 6.5 6.5 7.0 6.5 7.5 6.5 6.9 .39 10 Covance 6329-225 3M T-6314.1 276 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: 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 Dosage 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 Dosage 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. 277 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-6314.1 278 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 C95958 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: 10 _ 30 10 - 30 30 30 10 10 10 10 - 100 Dosage Unit: ppm MeFOS +_ -- +-- -- +-- ++ +- + _ - - - - - Dosage Unit: ppm MeFOS __ _ ++ -- ++ - ++-- -- +++ +- - - - +++ - _ - - - - - _ - Covance 6329-225 3M T-6314.1 279 a Appendix 5 Covance 6329-225 3M T-6314.1 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 RBC WBC EPITH BACT CASTS CRYSTALS PER HPF PER HPF PER HPF PER HPF PER LPF PER LPFl 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 it: ppm MeFOS 030 130 130 120 130 120 010 130 120 120 Dosage i it : 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 280 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 APPI Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C9596B 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 1 10 020 020 120 120 010 130 110 120 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-6314.1 281 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 VOL ML SP GR U PH Group: 1 C959B3 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 Dosag 6.5 7.0 7.0 6.5 6.5 6.5 6.5 7.0 6.5 7.0 6.7 .26 10 Dosag 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-6314.1 282 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 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 C96050 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 Unit: ppm MeFOS 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 Unit: ppm MeFOS 6.5 6.5 6.5 6.5 6.5 6.5 6.5 6.5 7.0 7.0 6.6 .21 10 Covance 6329-225 3M T-6314.1 283 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 KET U BILI U BLOOD UROBILI 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 30 0 0 0 10 0 30 0 10 10 Dose Level 10 10 10 10 0 10 10 10 0 Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Covance 6329-225 3M T-6314.1 284 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 D 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: 10 _ 010 010 10 10 10 10 0 30 Dose 10 30 10 10 0 10 10 10 0 0 Level: _ - 100 Dosage Unit: ppm MeFOS __ _ --------- -- - - Dosage Unit: ppm MeFOS _- -- -- --- - -- - -- - --- - -- _ - - - - Covance 6329-225 3M T-6314.1 285 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 : 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 C96Q07 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-6314.1 286 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 LPFl URINE COMMENTS APP1 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 40 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-6314.1 287 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 288 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: 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 1.0 0 0 0 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 289 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) APPENDIX 6 I n d iv id u a l A n a to m ie P a th o lo g y D a ta 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 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) .0754 2.1335 4.1240 15.9820 .8310 3.5597 .2540 .0198 .0151 % .4262 % .8238 % 3.1926 % .1660 % .7111 % .0507 % .0040 % .0353 1.0000 1.9330 7.4910 .3895 1.6685 .1191 .0093 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 291 i APPENDIX 6 Covance 6329-225 3M T-6314.1 I n d iv i d u a l A n a to m ic P a th o lo g y D a ta 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 4 ANIMAL NUMBER: C95902 DATE OF DEATH: 12/02/98 ,,,,,, noav ronnp 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE SEX: MALE SE G R 0 G ' STUDY DAY OF DEATH: 9 3 S T U D Y ER op WEEK OF DEATH. DEATH. 14 TERMINAL BODY WEIGHT: 500.6 GRAMS IE REC0RDER; TERRI L _ WILLIAMS DATE AND TIME OF NECROPSY: 12/02/98 10:38 PROSECTOR. JODI THI REN^ WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST. ___________________________________________________ HARDERIAN ^GLAND^^HGK^AUDITORY^SEB GL^ (AS^^SKIN^^SK)^URINARY ^BLADDER^ (UB^! #PROSTATE (PR). SEMINAL VESICLES CSV) . TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE A T "^ SCg TM TM ^ ^ g E t TIB O ^ STERNUM (SB), EYE (EY) , BRAIN (BR) , BONE, FEMUR (FE) , MARROW ? ' HEART (HT( MUSCLE SKELETAL (SM) , NERVE, SCIATIC (SN) , SPINAL CORD (SC), ^ ^ (TR) . ESOPHAGUS ES , L I V E R ^ L I ^ HEART CORTEX (AC), ADRENAL, MEDULLA (MA) , SPLEEN (SP), LN, MESENTERIC , T i mO I D (TY) , PARATRYROID (TO PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , TM {i l !' ce S T e )<Pc o Lo n T (t o )^" 'RECTm b " v " ' ( S G ), HARDERIAN GLAND (HG). a u d i t o r y s e b GL (AS). SKIlT (SK)'! 'URINARY BLADDER ^UB) 7 SEMINAL VESICLES (SV) TESTIS_ (TE) . ^ _______________________________ 292 A PPEN D IX 6 I n d iv i d u a l A n a to m ie P a th o lo g y D a ta 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: 12/02/98 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 ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STAI: u s 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 293 I 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: 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) 294 APPENDIX 6 Individual Anatomie Pathology Data C o v an ce 6 3 2 9-225 3M T - 6 3 1 4 . 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 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 295 A PPEN 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: 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 GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS O B S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY 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) 296 APPENDIX 6 Individual Anatomic Pathology Data C ovance 6 3 2 9 -2 2 5 3M T - 6 3 1 4 . 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 297 A PPEN 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: 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) 298 APPENDIX 6 Individual Anatomic Pathology Data C ovance 6 3 2 9-225 3M T - 6 3 1 4 . 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 S T A I ?U S 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 % .4146 .6897 % 3.3224 % .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 299 A PPEN 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: 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) 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: 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 (GC) : -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 301 A PPEN 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: 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) A PPEN 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (k d > LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0571 2.1256 3.4921 13.0677 .8254 3.3149 .5078 .0193 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0113 % .4209 % .6915 % 2.5877 % .1634 % .6564 % .1006 % .0038 % ORGAN TO BRAIN WEIGHT RATIO .0269 1.0000 1.6429 6.1478 .38B3 1.5595 .2389 .0091 O R GA 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 HI STOPATHOLOGY 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 303 APPENDIX 6 I n d iv id u a l A n a to m ic P a th o lo g y D a ta 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:I: 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), SALIVGL, 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), SALIVGL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SKIN (SK) , URINARY BLADDER (UB) , SEMINAL VESICLES (SV) , TESTIS (TE) , EPIDIDYMIDES (EP) 304 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 O B S E R VATI!0N S 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 305 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: 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) 306 APPENDIX 6 Individual Anatomic Pathology Data C o v an ce 6 3 2 9 -2 2 5 3M T - 6 3 1 4 .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 (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0412 2.2483 4.4547 16.2577 .8328 3.6513 .5244 .0345 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0072 % .3918 % .7764 % 2.8333 % .1451 % .6363 % .0914 % .0060 % 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 NECROPSY OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL -MINERALIZATION, VASCULAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL KIDNEY (KD) : -BASOPHILIC TUBULES, CORTEX,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL 307 b 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: 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 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) , 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) 308 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) 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: 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 STATUS 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) 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) 311 P r 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: 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) 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: 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 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) ------------------- 7.5432 -------------------------- ------------------- 2.8791 % ------------------------- ------------------------------------------------- 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) 313 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: 26 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, UP 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 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 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: 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 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 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), 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) ,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) 315 1 4 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0545 2.0848 4.3299 13.8740 .7099 3.4976 .3380 .0278 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0102 % .3920 % .8140 % 2.6084 % .1335 % .6576 % .0635 % .0052 % ORGAN TO BRAIN WEIGHT RATIO .0261 1.0 0 0 0 2.0769 6.6548 .3405 1.6777 .1621 .0133 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 RECTUM (RE) : -PARASITISM,-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 316 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, 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), 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) 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0547 2.0931 3.6402 14.9341 .7976 3.2582 .2806 .0265 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0 111 % .4231 % .7358 % 3.0188 % .1612 % .6586 % .0567 % .0054 % ORGAN TO BRAIN WEIGHT RATIO .0261 1.0000 1.7391 7.1349 .3811 1.5566 .1341 .0127 O RGA N STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY 0 B S E R \r A T I O N S HISTOPATHOLOGY THYMUS (TH) : -RED FOCUS(I)/AREA(S); DIFFUSE: MULTIPLE DARK RED AREAS, UP TO 3 X 2 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, --MINIMAL THYMUS (TH) : -HEMORRHAGE,--MINIMAL 318 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) 319 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0603 2.2555 4.1905 16.3018 .9470 3.1638 .2340 .0308 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0115 % .4305 % .7999 % 3.1116 % .1808 .6039 % .0447 % .0059 % ORGAN TO BRAIN WEIGHT RATIO .0267 1.0000 1.8579 7.2276 .4199 1.4027 .1037 .0137 ORGAN STATUS 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 APPENDIX 6 Individual Anatomic Pathology Data Covance 632S-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 (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), SALIVGL, 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 (SN), 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) 321 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0685 2.1808 4.1319 15.1321 .8162 3.1121 .4094 .0193 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0133 % .4241 % .8036 % 2.9428 % .1587 % .6052 % .0796 % .0038 % ORGAN TO BRAIN WEIGHT RATIO .0314 1.0000 1.8947 6.9388 .3743 1.4270 .1877 .0088 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 THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL 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) 323 APPENDIX 6 Individual Anatomie Pathology Data C ovance 6329-225 3M T - 6 3 1 4 . 1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGEi 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 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) .0513 2.2655 3.4063 13.6319 .7113 3.1045 .2703 .0315 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0107 % .4736 % .7120 % 2.8495 % .1487 % .6489 % .0565 % .0066 % ORGAN TO BRAIN WEIGHT RATIO .0226 1.0000 1.5036 6.0172 .3140 1.3703 .1193 .0139 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; 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) 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: 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) 325 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: 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 1.0 0 0 0 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) 326 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0561 2.1774 3.7379 13.9536 .9245 3.5483 .3028 .0248 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0113 % .4367 % .7497 % 2.7986 % .1854 % .7117 % .0607 % .0050 % ORGAN TO BRAIN WEIGHT RATIO .0258 1.0 0 0 0 1.7167 6.4084 .4246 1.6296 .1391 .0114 ORGAN STATUS 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 -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) 327  4 APPENDIX 6 Covance 6329-225 3M T-6314.1 Individual Anatomie Pathology Data 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0628 2.2194 3.9763 14.6970 .6523 3.1815 .2829 .0261 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0134 % .4739 % .8491 % 3.1384 % .1393 % .6794 % .0604 % .0056 % ORGAN TO BRAIN WEIGHT RATIO .0283 1.0000 1.7916 6.6221 .2939 1.4335 .1275 .0118 ORGAN STATUS 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 328 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) 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: 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) 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) BRAIN (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: SINGLE DARK BROWN LINEAR AREA, 3 X 1 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR' TAKEN 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) 331 APPENDIX 6 Individual Anatomic Pathology Data C ovance 6329-225 3M T - 6 3 1 4 . 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 % 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 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) 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 DATE 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 RGAN 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 OBSERVAT ION S HISTOPATHOLOGY THYMUS (TH) : -RED FOCUS(I)/AREA(S); RIGHT LOBE: SINGLE DARK RED AREA, 6 X 3 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN 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) 333 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL T T / '\ r r \ n n m * M l ? a T ,l T .T ? n K I A M T n O ETHANOL {N"MEFOSE, T o j 14) PAGE: 46 ,,,,,,,,,, t o iP B T P T C F STATUS- SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C95930 SEX: MALE DOSE GROUP. 2 0F Se ATH: i f DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY 12/02/98 DAY OF 8:59 DEATH: 93 Twr s PROSECTOR: KEVTM BILLINGS PATHOLOGIST: JOHN EIGHMY TERMINAL ODY WEIGHT: 484.0 GRAMS RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER _________________________ POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) E ORGAN WEIGHT (GRAMS) .0711 2.0340 3.8914 15.3859 .8442 3.4684 .4143 .0169 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0147 % .4202 % .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 STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN OBSERVATIONS HISTOPATHOLOGY NECROPSY KIDNEY (KD) : ' - S l I f S l i L ; . . LEFT, WITHIN PELVIS: MULTIPLE TAN, PINPOINT GRANULES GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN _ LI^INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL KIDNEY (KD) : -DILATATION, PELVIC,-SLIGHT APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PEFFT.UOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 47 ANIMAL NUMBER: C95930 DATE OF DEATH: 12/02/98 SEX, HADE STUDY D A Y DATE AND TIME OF NECROPSY: 12/02/98 ~ POST-FIX WEIGHER: NOT AVAILABLE JOSE 0 O U , ^ EXCJIPICE f ATOS, pimni OCIST JOHN EIGHMY PATHOLOGIST^JOHN ECOK.EE, WEEDY CHEERY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY), BRAIN (BR), BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (S ), ' . HEART (HT) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) -ESOPHAGUS (ES), LIVER LI^ H E A R T I. pARATHYR0ID (PT). NERVE, SCIATIC (SN) , SPLEEN <S P ) <TM) , LN, ^aO ^ P I T U I T A R Y (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , ADRENAL, CORTEX (AC), ADRENAL, M E DU S A (^) , AOR A ( > , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), S EGL `mANDIBE^(SG?^^HARDERIANJGLAND^(HG) , 1 AUDITORY SEB^GL^(AS) ! SKIN (SK) . URINARY BLADDER (UB) . PROSTATE (PR, , S E M ^ L l VESICLES (SV) . TESTIS (TE) , EPIDIDYMIDES_ (EP) ,_TAIL_ (TI)__________________________________________________ 335 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL nnnoT TTnorw'ti'sMucm.pnNiMTnn ETHANOL (N-MEFOSE, T-6314) PAGE: 48 ANIMAL NUMBER: C95931 DATE OF DEATH: 10/01/98 SEX* MALE STUDY DAY OF DEATH: DOSE GROUP: 2 SACRIFICE STATUS: 31 STUDY WEEK OF DEATH: 5 SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 362.7 GRAMS RECORDER: KEVIN BILLINGS DATE AND TIME OF NECROPSY: 10/01/98 11:47 ^ISsTfjS^E^H^ ______________ WEIGHER: _MICHELE_ZIMA_____________ POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) nOnRnGAANN TTOO BBRRAAIINN WEIGHT RATIO SOTRA GT U S NOT TAKEN ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) 11.8205 3.2590 % NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THYROID/PARATHYR (TT) ADRENAL, CORTEX (AC), ADRENAL, MEDUi ^ , PANCREAS (PA), DUODENUM (DU) , JEJOTIUM (JE), I S " S I H i: ,iT, 'rECUM (CE) COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), TM (Asf SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), ___________________________ 336 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL OERET.nnRnnCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) PAGE: 49 , SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE ANIMAL NUMBER: C95932 SEX: MALE !?SE GR0^ ' WEEK OF DEATH- 5 TERMINAL BODY WEIGHT: 329.1 GRAMS DATE OF DEATH: 10/01/98 STUDY DAY OF D E A T H : h K jSw M RECORDER: KEVIN BILLINGS DATE AND TIME OF NECROPSY, J.0/01/98 11:42 PATHOLOGIST^JOHFM2IGHMY __________ WEIGHER:_MICHELE_ZIMA___________ POST-FIX WEIGHER: NOT ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) 9.9205 3.0144 % NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THYROID/PARATHYR (TT) THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECR9,P,S Y ,eD, nnNP STERNUM (SB). EYE (EY) , BRAIN (BR) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM ( ), ' > KIDNEy (RD) , HEART (HT) , MUSCLE, SKELETAL (SM) SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR> ' Ef0P^ G U S (ES) , LIVER L I J ^ I D N E ^ ('pARATHYROID (PT) , NERVE, SCIATIC (SN) , SPLEEN (SP>1 ^AO^^PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), ________________________ 337 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL TTfinnn/'fnuxTi'CTTT.pnMaMTnn ETHANOL (N-MEFOSE nl-- PAGE: 50 d a t e ^of^ d e a t h ! 10/01/98 SACRIFICE STATUS: SCHEDULED, FIRST TM T ERIM 5 TERMINAL BODY WEIGHT: 341.3 GRAMS I S i / S S o f d e a t h : ? f E GROs?imY WEEK OF DEATH: RECORDER: KEVIN BILLINGS DATE AND TIME OF NECROPSY: 10/01/98 11:44 PATHOLOGIST^JOHN^EIGHMY POST-FIX WEIGHER: NOT AVAILABLE _____________ PATHOLOGIST^ JOHN ________ WEIGHER: MICHELE ZIMA ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) 11.2465 3.2952 % NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THYROID/ PARATHYR (TT) 'THE FOLLOWING ORGANS WERE J ^ n w ^ S T E R N U M (SE) BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , BONE, FEMUR (FE), MARROW, FEMUR (FM) , ^ ^ O W , S T E R ^ (SE) , UN , KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC) , LUNG (LU) . TRACHEA (TR) P" GUS (ES) , L I V E ^ (LI),^ ^ ^*PARATHYROID (PT), _____ L S s issi: ____ APPENDIX 6 I n d i v i d u a l Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL ,,^rununncTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RA PAGE: 51 ,, n.poTPTrs' STATUS" SCHEDULED, FIRST INTERIM SACRIFICE ANIMAL N^BER: 5934 It O T Y ^ A Y OF DEATH: Si" ^ S T O D Y WEEK OF DEATH: 5 DATE OF DEATH, _10/01/98 10/01^98 il:50 DATE AND TIME OF NECROPSY: POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) 9.9286 3.1321 % ^ r e CORDEr! KEVIN^BILLINGs" G ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS WERE ^REMARKABLE AT NECROPSY: EYE (EY) , BRAIN (BR) , 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: 52 ANIMAT N U M BER- C95935 DATe\>F d e a t h ! 10/01/98 SEX- MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY " H h M - 6 GRAMS DATE AND TIME OF NECROPSY: 10/01/98 12:07 POST-FIX WEIGHER: NOT AVAILABLE PROSECTOR: TONY HANFELD PATHOLOGIST: JOHN EIGHMY wilGHER 'MICHELEZIMA WEIGHER. ^MICHELE^ZIMA___________ ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) ------------------- 11.8361 ------------------------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) 3.3379 % ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE BONEOWFEMURR (^f K w SYSTERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , Sp i nalTM (s c )', " (l u I ^ L c h e a (t r ) e m p h a g u s (s )! l i v e r (l i ), k i d n e y (k d ), h e a r t (h t ) m u s c l e , s k e l e t a l (s m ), N ER V E SCIATIC (SN) SPLEEN (SP) THYMUS (TH), LN/ MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT)# ADRENALf^CORTEX ^AC) ,^ADRENAuf MEDULLA (MA) , AORTA (AO), PITUITARY (PI), PANCREAS (PA) DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) , CECUM (CE), COLON (CO), RECTUM (RE), LN , . \ 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) 340 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYD PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 53 ANIMAL NUMBER: C95936 DATE OF DEATH: 12/02/98 ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR city MALE DOSE GROUP: 2 SciAnCjRTIPFTIfCPEJSTTAATTUUSS.* SCHEDULED,q Td EYRWMEIINGAHLT:SACRI5F5I0C.E9 GRAMS SSTTUUDDYY DDAAYY uOrF DuEATH:pR903SECT0R.STJUEDRYALWDEWE.K OJFOHDNESAOTNH: R EC O R D ER : WENDY CHERRY L ^ 2/98 9:51 _ _ = ^ S T f ^ _ E I O H ^ ________________ WEIGHER:_L^_HORNER______ (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0484 2.0694 4.1177 15.6498 .7959 3.1581 .3262 .0188 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0088 % .3756 % .7474 % 2.8408 % .1445 % .5733 % .0592 .0034 % ORGAN TO BRAIN WEIGHT RATIO .0234 1.0000 1.9898 7.5625 .3846 1.5261 .1576 .0091 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY L 1 -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION: LEFT, UPPER INCISOR THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY^ BONE, FEMUR (FE) , MARROW, FEMUR (FM) SPINAL CORD (SC), LUNG (LU), TRACHEA (SM) , S A L IV GL M ANDIB ( S G ) , HARD ERIA N GLAND ( H U ) , A U D ii u n i SEM INAL 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 <EP) 341 APPENDIX 6 individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL Tinoru^r'rpaKiPQTTT.pnNAMIDO ETHANOL (N-MEFOSE, T-6314) PAGE: 54 n eirBTPTPP STATUS* SCHEDULED TERMINAL SACRIFICE A N I M A L NUMBER: 5 9 3 7 ^ 0F DEATH: " STUDY WEEK OF DEATH: 14 WENDY^CHERRY4 GRAMS DATE AND TIMe 'o F NECROPSY:12/02/98 11:10 ^E^HMY WEIGHER: LYNN HORNER___________ POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) _______ ---------------------------------------------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO .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 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN OBSERVATIONS HISTOPATHOLOGY NECROPSY LI^i n f i l t r a t e , LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS THE FOLLOWING ORGANS WEREJTOREMARKABLE^AT NECROPSY: BONE, FEMUR S i i ( S TM S i E . SKELETAL U W . =Vr^DPKiaT PORTEX (AC) ADRENAL, MEDULLA (MA), *unia .\k \j ,s r TM (Sii. URINARY BLADDER (UB) , PROSTATE (PR), APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-MET/H-,YSLA\ TM T>MHO t>noAnfimiMi'qniivnN&MIDO ETHANOL (N-MEFOSE PAGE: 55 ** e'^vrt^TT^T^,'c, QTATTIS* S C H E D U L E D / T E R M IN A L S A C R I F I C E s s ? V 3 & : s , " so f ^ z u ' TM" s s s f TM - 6 " " ' "' ,, s s a . f s s r s s , _______ ------------------------------------------ ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0579 2.1368 4.1230 16.5589 .5647 3.6229 .3002 .0272 ORGAN WEIGHT RELATIVE TO BODY WEIGHT {%) .0116 % .4294 % .8286 % 3.3278 % .1135 % .7281 % .0603 % .0055 % ORGAN TO BRAIN WEIGHT RATIO .0271 1.0 0 0 0 1.9295 7.7494 .2643 1.6955 .1405 .0127 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN OBSERVATIONS HISTOPATHOLOGY NECROPSY LI^ N F I L t t , LYMPHOHISTIOCYTIC, -MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS i r ,sK"ai='i*s^^?s?i^ ^ "sr0ss<jsa'snisrsoS: -- ., AHRFNAL CORTEX (AC) . ADRENAL, MEDULLA (MA) , AORTA (AO) . PITUITARY <*1 >' 1^rH) RECTUM (RE), LN. MANDIBULAR (MN) . PANCREAS (PA), DUODENUM (DU) , JEJUNUM (JE) ^ GL (AS) ,*SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SSfwBSS 88: S S ,S r S A a S 18g.r^.: 343 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-MET/HnYi Ln r m m rinDnnr-TSMFSnT.FnNAMIDO ETHANOL (N-MEFOSE m tm nmO PAGE: 56 ANIMAL NUMBER: C95939 S SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE fmnnv^av OF DEATH- 93SE GRSTUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 447.8 GRAMS RECORDER: WENDY CHERRY 12/02^98 S T 2f ^ P R ^ C T O R : T o Sn S. EHIAgWLFORD ______ WEIGHER: _LYNN_HORNER___________ POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0634 2.3237 3.6350 12.6033 1.1088 3.2485 .4355 .0289 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0142 .5189 .8117 2.8145 .2476 .7254 .0973 .0065 ORGAN TO BRAIN WEIGHT RATIO .0273 1.0000 1.5643 5.4238 .4772 1.3980 .1874 .0124 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LI^i n f i l t r a t e , LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS " SL <" >' <UB>' PR0STATE (PR)' SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES^(EP):_TAIL ( T V _________________________________________________ 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: 57 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C95940 DATE OF DEATH: 12/02/98 D TM A ND ^TIM E ' OF~NECROPSY : qpv. MALE STUDY DAY OF 12/02/98 8:10 DEATH: ^ DOSE 93 Ss GROUP: 2 STUDY T ^ JO WEEK OF DEATH: ^ E IC H ^ 14 TERMINAL BODY WEIGHT: 483.1 GRAMS RECORDER: STEVE VAN ADESTINE YW E IG H E R TO N Y H A N F E L D P O S T -F IX W EIGH ER: NOT A VA ILA BLE PATHOLOGIST . JU H N M b n n _____________________________________________________________________________ ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0659 2.1363 4.1869 14.1874 .8620 3.8586 .2849 .0224 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0136 % .4422 % .8667 % 2.9367 % .1784 % .7987 % .0590 % .0046 ORGAN TO BRAIN WEIGHT RATIO .0308 1.0000 1.9599 6.6411 .4035 1.8062 .1334 .0105 ORGAN STATUS 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^ -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY) , BRAIN (BR) , . BONE, FEMUR (FE) , MARROW, FEMUR <FM) > (FS) 'LIVEr ' (LI) , KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) SPINAL CORD (SC), LUNG (LU) , TRACHEA <TR) ESOPHAGUS (BS), LIVER (T^ PARATHYROID (PT) , ADRENAL^CORTEX ^ AC),^ADRENAL^^MEDULLA^^MA^ AORTA ^^^^^PITUITARY* '<> . S ^ N (^ D DX ^ ? T k Y JTM S i : S K T d K t ! ' u R S Y lBLiiDER (UB) , PROSTATE ,PR) . SEMINAL VESICLES (SV) . TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 345 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL n^Dnru-'i'ziMi'qnT.FnNAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 58 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE ntyv UAT P DOSE GROUP -- . ANIMAL NUMBER: C95941 It o DY DAY OF DEATH: 93 STUDY W E E K OF DEATH: 14 DATE OF DEATH: 12/02/98 12/02/98 11:42 PROSECTOR: KEVIN BILLINGS DATE AND TIME OF NECROPSY: PATHOLOGIST: JOHN EIGHMY TERMINAL BODY WEIGHT: 411.5 GRAMS RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) ABSOLUTE ORGAN WEIGHT (GRAMS) .0457 2.1186 3.5249 13.6671 .8387 3.2827 .3528 .0182 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0111 % .5148 % .8566 % 3.3213 % .2038 % .7977 % .0857 % .0044 % ORGAN TO BRAIN WEIGHT RATIO .0216 1.0000 1.6638 6.4510 .3959 1.5495 .1665 .0086 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN THYROID/PARATHYR (TT) OBSERVATIONS HISTOPATHOLOGY NECROPSY LIVER (LI) : -h y p e r t r o p h y ^ h e p a t o c e l l u l a r , c e n t r i l o b u l a r ,-m i n i m a l -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITM / - M E T H Y L ,,TMTTTr,T>nn('n-naRfim.FONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS P A G E : 59 _ m n D T C i r c S T A T U S SCHEDULED, TERM INAL S A C R IF IC E ag" -2S: S55SJ- S.-5S . B " lf " i S S H P i - f f G""s i l s i H ^ 2'98 ___________ -------------------------------------- following tissues were unremarkable at microscopic examination. THE STOMACH, GL (ST), STOMACH, NONGL (SU) __________________________________________________________ 347 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 noocT Mnonr1u3--'TW'E&EWKERnDTI.EFTOANRAYMITDOOXEITCHIATNYOLSTU(DNY-MWEIFTOHSEN-METnHYiLA\ TXT X3 PAGE: 60 _ , csrcTPTrP STATUS SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C95942 D /TEOF DEATH: 12/02/9 SEX: MALE ,, 99SE GRc t ud Y WEEK OF DEATH: 14 SShS I S s s s - s s s ; i s , 's S i D i i TM / " 10-58 _ ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) 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 ____________________ ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0166 % .4945 % .9830 % 3.5488 % .1628 % .8597 % .0613 % .0042 % ' TERMINAL BODY WEIGHT: 418.7 GRAMS RECORDER: WENDT CHERRY WEIGHER: LYNN HORNER ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS .0335 1.0 0 0 0 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 k^-HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-lffiTHYL ocTjvr.nnnnnfTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 61 Ann nnntm c s p b t p t p p STATUS* SCHEDULED. TERMINAL SACRIFICE ANIMAL NUMBER: C95942 SEX: MALE ^OSE G R O U ^ ^ ^ M TM A L rBODY '7 GRAMS DATE OF DEATH: 12/02/98 STUDY DATE AND TIME OF NECROPSY: 12/02/98 POST-FIX WEIGHER: NOT AVAILABLE DAY OF 10:58 DEATH: PROSECTOR: JERALD PATHOLOGIST: JOHN W. JOHNSON EIGHMY w p t P H F R - LYNN HORNER ____ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY) , BRAIN (BR) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , *' l TM r '(LI) , KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES), u (TY) , PARATHYROID (PT) , NERVE, SCIATIC (SN) , SPLEEN (SP), (TH) LN, (PI) . STOMACH, GL (ST), STOMACH, NONGL (SO). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , .* .*'CECUM (CE) , COLON (CO), RECTUM (RE), SALIVGL, MANDIB (SG) , S TM <S>: m . <> *.. a <*n . TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST) , STOMACH, NONGL (SU) ___ _______________________________________________________ 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: 62 ANIMAL NUMBER: C95943 DATE OF DEATH: 12/02/98 oPx. MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 500.1 GRAMS RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 11:21 PROSECTOR: JERALD J O H N ^ N WEIGHER:'LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY____________________ "___________________________________ 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 OBSERVA TI0N S HISTOPATHOLOGY LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC -MINIMAL -VACUOLATION, HEPATOCELLULAR, DIFFUSE, -MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 350 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL nwnoTnnDnnrfi'awv.RTTTiPnNAMIDO ETHANOL (N-MEFOSE, T-6314) PAGE: 63 SEX- MALE ADDPNAAOITTSMEETA-LOAFFNINDXUDMEWTBAEIETIMRHGE::HEORCF1:925/N90EN4C2O3R/TO9P8ASVYA:ILA1B2L/ES0T2U/D98Y DAY OF 11:21 DOSE GROUP: 3 SACRIFICE STATUS: DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: JERALD W. JOHNSON PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 500.1 RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER GRAMS THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY) , BRAIN (BR) , BONE, FEMUR (FE) , MARROW, FEMUR (FM>- 'II W r '(LI) KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) P" GUS (ES) L I VE R ( L I^ ^ PARATHYROID <PT) , NERVE, SCIATIC (SN) , SPLEEN (SP) ' ADRENAL, CORTEX (AC), ADRENAL, k r>WA ^ Aof^ITUITARY (PI) , STOMACH, GL (ST), STOMACH, NONGL (SU) , 'CECUM (CE) COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) . S (SK), URINARY BLADDER (OB). 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) 351 1 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 : 64 MrmnPTJ. pqsQiU 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 DATE AND TIME OF NECROPSY: 12/02/98 11:31 PROSECTOR: TODD ACKER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY TERMRECORDERY WENDY^CHERRY^ RECORDER WHiDY CHERRY 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) .0511 2.1737 3.9789 15.6049 .6847 3.4797 .2276 .0265 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0118 % .5018 % .9185 % 3.6022 % .1581 % .8033 % .0525 % .0061 % ORGAN TO BRAIN WEIGHT RATIO .0235 1.0000 1.8305 7.1790 .3150 1.6008 .1047 .0 12 2 ORGAN STATUS 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 -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT 352 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PFFFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T 6314) IN RATS PAGE: 65 S rS p" : ! OF S S S d " S ' O ^ liSs Y , 12/02/96 11,31 P O S T - F I X WEIGHER: N O T A V A IL A B L E SACRIFICE STATUS: DEATH: S T "" S d WEEK O F DEATH, 14 S S S st" ^ " !? P A T H O L O G I S T ^ J O H N ^ L I L H M I _________ SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 433.2 RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER GRAMS THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY) , BRAIN (BR) , BO N E, FEM UR ( F E ) , MARROW, FEMUR (FM ) - MARROW, STERNUM (S E ) BONE - STERN O ^ ) . HEART (H T ), M U SCLE, SK E L E T A L (SM ) S PIN A L CORD ( S C ) , LUNG (LU ) , TRACHEA (T R ) ' ^ O P ^ G U S (E S K L IV E R L I K ^ I D N ^ _ PARATHYROID (P T ) , NERVE, SCIATIC (SN) , SPLEEN (SP) ^aO ^ P I T U I T A R Y < pi ), STOMACH, GL (ST), STOMACH, NONGL (SU), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO) .PITUITARY ( ^ (C0) RECTUM (RE), SALIVGL, MANDIB (SG) , S iIn (G L ^ D D ( TM ^ (OB). 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) __________________ 353 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 TTnBn1n3P-'TW'AETEJKESDnILEFTOANRAYMITDOOXIECTIHTAYNOLSTU(DNY-MWEIFTOHSEN-METHY1LA \ TW RTfi PAGE: 66 ANIMAL NUMBER: C95945 DSATSE OF DEATH: 12/02/98 oEX. m a l e DOSE GROUP: 3 SACRIFICE STATUS STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 1 >2,02/98 8,17 SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 491.3 GRAMS RECORDER: WENDY CHERRY m m m . " * " * POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) rBinu ABSOLUTE ORGAN WEIGHT (GRAMS) .0502 2.1630 4.1701 17.2249 .6713 3.8878 .2839 ]0216 -------------------------- ORGAN WEIGHT RELATIVE ORGAN TO BRAIN TO BODY WEIGHT (%) WEIGHT RATIO .0102 % .4403 % .8488 % 3.5060 % .1366 % .7913 % .0578 % .0044 % .0232 1.0000 1.9279 7.9634 .3104 1.7974 .1313 .0100 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN OBSERVATION S HISTOPATHOLOGY NECROPSY H y p e r t r o p h y , h e p a t o c e l l u l a r , c e n t r i l o b u l a r ,-m i n i m a l -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, DIFFUSE, -MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS APPENDIX 6 Individual Anatomic Pathology Data Covanc 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 67 SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C95945 riATF nF DEATH- 12/02/98 SEX: MALE OSE GROUP: 3 Q ^ D E A T H ^ l i TM 0 3 ' TERMINAL BODY WEIGHT: 491.3 GRAMS STUDY DAY OF DEATH: 93 STUDY WEEK OF UtAiH. J. RECORDER: WENDY CHERRY DATE AND TIMe 'o F NECROPSY: 12/02/98 8:17 POST-FIX WEIGHER: NOT AVAILABLE p m h OLOGIST^JOHN^IGHMY PATHOLOGIST. ______________ WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY) , BRAIN (BR) , BONE. FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE) , BONE, _M,,Y lYT)\ HEART (HT) MUSCLE. SKELETAL (SM) SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 355 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PEPPr.TIOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) PAGE: 68 SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 469.0 GRAMS " S : 12/02/98 STUDy'd AY OF DEATH: ^ S T U D Y WEEK OF DEATH: 14 RECORDER: WENDY CHERRY 7:59 -- ' S _____________ WEIGHER: LYNN HORNER ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/ PARATHYR (T T ) ABSOLUTE ORGAN WEIGHT (GRAMS) .0648 2.3771 3.3029 15.7438 .7863 3.5288 .1989 .0365 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0138 % .5068 % .7042 * 3.3569 % .1677 % .7524 % .0424 % .0078 % ORGAN TO BRAIN WEIGHT RATIO .0273 1.0 0 0 0 1.3895 6.6231 .3308 1.4845 .0837 .0154 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 -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL rTrtorv-r>frftKnrCTTT.5,OMAMTno ETHANOL (N-MEFOSE, T-6314) PAGE: 69 SCHEDULED, TERMINAL SACRIFICE SEX- MALE ANIMAL NUMBER: C95946 DATE OF DEATH: 12/02/98 STUDY DATE AND POST-FIX TIME OF WEIGHER: NENCORTOPASVYA:ILA1B2L/E02/98 DAY OF 7:59 ' DOSE GROUP: 3 SACRIFICE STATUS: DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: JOHN S. HALFORD PATHOLOGIST: JOHN EIGHMY^ TERMINAL BODY WEIGHT: 469.0 RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER GRAMS THE AT NECROPSY:F O L L O W I N G O R G A N S W E R E U N R E M A R K A B L E STERNUM (SB), EYE (EY) , BRAIN (BR) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , . KIONEY (KD) , HEART (HT), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR) -ESOPHAGUS (ES) , LIVER (LI a r a THYROID (PT) , ADRENALSCCORTEX11AC),SA D R TM A ^ P^ D TM ^ UU ) , AORTA (AO) , PITUITARY' < ^ . iS il 5 fis .'SKI- (SK). RINARY BLADDER (UB, . PROSTATE (PR). SEMINAL^VESICLES ( S V ) . TESTIS (TE). EPIDIDYMIDES (EP). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 357 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL Trtrto/-vrtomAMT?cTU.irnNAMTnn ETHANOL (N--MEFOSE, T 6314) PAGE: 70 ANIMAL NUMBER: C95947 cpv. MALE STUDY DAY OF DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 9 -4 5 NOT AVAILABLE DOSE GROUP: 3 ScAiCPRRITFPITCfEP SSTTAATTUUSS- DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: NANCY DIEDRICH PATHOLOGIST: JOHN EIGHMY SCHEDULED,BODTYERWMEIINGAHLT:SACRI4F4I9C.E9 GRAMS RECORDER: TERRI L. WILLIAMS 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) .0507 2.1942 3.2317 15.1188 .8297 3.2832 .3773 .0232 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0113 % .4877 % .7183 % 3.3605 % .1844 % .7298 % .0839 % .0052 % ORGAN TO BRAIN WEIGHT RATIO 0231 1.0000 1.4728 6.8903 .3781 1.4963 .1720 .0106 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN OBSERVATIONS HISTOPATHOLOGY NECROPSY 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 ^^-HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE, -MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE, -MINIMAL APPENDIX 6 Individual Anatomic Pathology Data C ovance 6 3 2 9 -2 2 5 3M T - 6 3 1 4 . 1 13-WEEK DIETARY TOXICITY STUDY ITH N-METHYL .liiDnni-Ttmtirir.FnNAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 71 NUMBER: g SS TS'o^lsV, POST-FIX WEIGHER: NOT AVAILABLE - 0P DEiIB, ?$" r>KroTT?TPi? C'PATTTS* SCHEDULED* TERMINAL SACRIFICE BEK 0 ^ = ' : ! " TM ' TM S f '. = TM ; ^ Co5n M S " __ __________________________________________________ __________ "TM "s s .TM, es s biTM" s s s ^ eteTM (|bit^ ' (s f " Ds 'iKSiE isTM isTM e & u . s m <, S r a i m c S n Si: "in.G a m . t m c h e r ' TM ! m , r b r e n a l , c o r t e x cl, NErRuVmE,, SSCCIIAATTIICC ((SSNN)),, SPLEEN (SP) , L^. MESENTERIC ( M 'iMACHR0 QL (ST), STOMACH, NONGL (SU) , PANCREAS (PA) , ADRENAL, MEDULLA (MA), AORTA (AO ' TM T A R Y (PIK STOMACH, ^ TUM (RE) _ SALIV GL MANDIB (SG) , (DU), JEJUNUM (JE) -,,pEUM (IL) , CECUM (CE) , COLO ^ BLADDER (UB), PROSTATE (PR), SSEEMMIINNAALL VESICLES (SV) HARDERIAN 'GLANd"~(HG), AUDITORY SEB GL (AS) , TESTIS (TE) , EPIDIDYMIDES (EP)* TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL ( S W __________________________ 359 A PPEN D IX 6 Individual Anatomie Pathology Data C o v an ce 6 3 2 9-225 3M T - 6 3 1 4 . 1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 72 ANIMAL NUMBER: C95948 SEX: MALE DATE OF DEATH: 12/02/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 12/02/98 9:44 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 3 SACRIFICE STATUS: DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: JOHN S. HALFORD PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 476.3 GRAMS RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) IGHT RELATIVE 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) .0458 2.1430 3.6102 13.4487 .8221 3.2511 .3464 .0202 .0096 % .4499 % .7580 % 2.8236 % .1726 % .6826 % .0727 % .0042 % .0214 1.0000 1.6846 6.2756 .3836 1.5171 .1616 .0094 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 360 A PPEN D IX 6 I n d iv i d u a l A n a to m ic P a th o lo g y D a ta Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHuYLn Tw na*r<5 netsc*t.nrvDoor'T'AMRflnijPONAMIDO ETHANOL (N-MEFOSE Pp~ PAGEi 73 BOSS moot. 3 .a o H je ., .. ANIMAL NUMBER: C95948 np DEATH- 93 STUDY WEEK OF DEATH 14 DATE OF DEATH: 12/02/98 STU?Y DATE AND TIME OF NECROPSY: 12/02/98 POST-FIX WEIGHER: NOT AVAILABLE DiY .?F 9:44 DEATH:PROSECTOR: JOHN S. HALFORD PATHOLOGIST: JOHN EIGHMY RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER shahs THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR <FM) ' , ^ R0 " ln STERNUM (SB), EYE (EY) , BRAIN (BR) , . (f I\ 'LIVER (LI), KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) i S ! ' pposTM ' " ( pS ' seh. ai. ' vhsicles ISVI. 361 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PEPFr.TJOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T 6314) IN RATS PAGE: 74 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE ADDPNAAOITTSMEETA-LAOFFNINDXUDMEWTBAEIETIMRHGE::HEORCF1:925/N90EN42CO9/RTO9P8ASVYA:ILA1B2L/'ESS0ET2XU/-9D8YMAD1LA1EY:44OF DEATH: DOSE 93 GROUP: 3 STUDY WEEK OFF DDEEAATTHH:: PROSECTOR: JILL PAUS PATHOLOGIST: JOHN EIGHMY 14 TERMINAL BODY WEIGHT: 421.1 GRAMS RECORDER: WENDY CHERRY 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) .0562 2.0546 3.9393 14.9562 .7402 3.5816 .1584 0219 .0133 % .4879 % .9355 % 3.5517 % .1758 % .8505 % .0376 % .0052 % .0274 1.0000 1.9173 7.2794 .3603 1.7432 .0771 .0107 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 362 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 M K NUMBER i C95949 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL -- Ti/-mi-r1r'mMi?CTTT.T7nMftMTnO ETHANOL (N-MEFOSE, T 6314) PAGE: 75 "S mTE.^ SCHEDULED, TERMINAL SACRIFICE " " Sir,? * E K ol" TM TM 8' TERMINAL BODY RECORDER: WEIGHT: 421.1 WENDY CHERRY GRAMS WEIGHER: LYNN HORNER ___________ SSi S,i?c',sripS- < S ^ u TM S s T 5 E is i' .srSoS: r sr i? o S : o*l,m. ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , .< )( c e c UM1 (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), " <>. BLM,BR <U> .OST.TB () . SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), STOMACH, GL (ST), STOMACH, N0 N^ _ ^ 1 _ 363 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: 76 AnN.ImMALOFNUnMFBAETRH:- C1925/90520/98 SSETXU:DYMADLAEY OF DEATH: 93SE STUDYj WEEK OOr^DDEEAiAnT.H ^J.l f TM 05 DATE AND TIMe 'o f NECROPSY: 12/02/98 10:29 POST-FIX WEIGHER: NOT AVAILABLE patHOLOGIST^JOHN^IGHMY PATHOLOGIST. JOHN^EIGHMY______________ SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 467.6 GRAMS RECORDER: TERRI L. WILLIAMS 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) .0593 2.2213 3.8346 15.5750 .6608 3.4323 .2306 .0259 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0127 % .4750 % .8201 % 3.3308 % .1413 % .7340 % .0493 % .0055 % ORGAN TO BRAIN WEIGHT RATIO .0267 1.0000 1.7263 7.0117 .2975 1.5452 .1038 .0117 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY -RED FOCUS(I)/AREA(S); BOTH LOBES: MULTIPLE DARK RED AREAS, UP TO 5 MM IN DIAMETER GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-SLIGHT -INVOLUTION, -MINIMAL 364 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY W I T H ! , TN PRPPT.nnROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 77 ssANIMAL NUMBER: C95950 POST-FIX WEIGHER: SCHEDULED, TERMINAL SACRIFICE ___ctUDY^DAY OF DEATH- 93TM ^STUDY WEEK O ^ D E A T H ^ l I TM 08` TERMINAL BODY RECORDER: WEIGHT: TERRI L. 467.6 GRAMS WILLIAMS WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT ^CROPSY: BONE STERNUM (SB), EYE (EY) , BRAIN (BR) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) ' <pg\ 'rTv e r ' (LI) KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) SPINAL CORD (SC), LUNG (LU) TRACHEA (TO). ESOPHAGUS (ES^ >^ h YRo Id (PT) , ADRENAL, CORTEX (AC), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), 1TH ( STOMACH NONGL (SU), PANCREAS (PA), ADRENAL, MEDULLA (MA) , AORTA (A9> ' ^ ^ ^ P C I I M ^ C E I ^ C O L O n ' (CO) SRECTUM (RE)', LN, MANDIBULAR (MN) , SAL?VNGL. HARDERIAN^GLAND (HGK AUDITORY SEB GL (AS) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL ( THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) ________________ 365 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY^STUDY^WITH^N-METHYL^ Covance 6329-225 3M T-6314.1 PAGE: 78 i e a c r t f TCE STATUS* SCHEDULED, F IR S T IN TER IM S A C R IF IC E SSrSF-SSS; ilT o D sS STUDY^DAY OF S TM TM r Or F D E A T H : 5 SSSVJSs" " " " P o l ? - TM WEiL e R:NTM vIil1b LE1/98 " '" ----------------------------------------------------------------------------------W E IG H T ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) PATHOLOGIST: JOHN EIGHMY___________________ RICHER: _MICHELE_ZI_MA---------- OHGANo W EIGH Tg R E L A T IV E ORGANhT 0 r B R A IN ORGAN STATUS ( GRAMS 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: 1HE Bl UO^NUE,V l iFBEOMUR SPINAL^ CORS 1(FE) , MARROW, wFiETMMrUTRR ((F*MM)) r__S__C__)'. L U N G ( LI t Ur t)\ , mT*RD AA rCuHiE? AA MMAARRRROCWW,. SSTERNUM (SE) , BONE, (TR) -ESOPHAGUS (ES) . LIVER LI NFRVE SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THXKUi anRFNAT CORTEX (AC) ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY ( )' ' . J P h e a r t ^HT)^ MUSCLE, SKELETAL (SM) , '<p t >. v ^ , ^ (ST) # STOMACH, NONGL (SU) , RECTUM (RE), LN, MANDIBULAR (MN) , s a f i S 'IS): __________________________ APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY ,,^nnwswucnr.mNAMI DTOOXIECTIHTAYNOLSTU(DNY-MWEIFTOHSEN-MmE-The'-Hi nY1aL \ TM t>7\rpC PAGE: 79 1 cipdtptpp STATUS- SCHEDULED, FIRST INTERIM SACRIFICE S S ^-S S S : HS. S " " STM, -- S S ? TM d DS ; S ' o ; 2 ? y ._i o / i ,9b 11,25 S S S t" S . " S * POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) 11.6980 3.6961 % " - B&SEBSTt u SSi 5" ___________ ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN JkFMSS"(ill!'iSS' (Si" TM"1iiSlS i wkSLb. sm-r. <> n e r v e ? K T i ! C ( S N ) TM w i m (s p ). t h y m u s W h ) l n ^ o f ^ P i m TM ' (piI?s t o m a c h ; gH stTM 0c t o m a c h . NONGL ^SUK SALIV ^ exdM GL, MANDIB (SG) , THXAERSDTEIRSI'*A(NTE)G''LT,AaiNEaD<PnIrD<IHGD)Y_.MIxADUEDSIT(OERP)Y iSEB GL- , TAIL (AS),s SKIN (-SK) . J (TI) , GENERAL^COMMENT^ _S S (^^)^_______________ SEMINAL VESICLES (SV) , ,. 367 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 ^ f 0 F TM H i 10/01/98 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 326.4 GRAMS STUDY^DAY OF DEATH: S T "" 1 WEEK OF DEATH: 5 RECORDER: KEVIN BILLINGS DATE AND TIME OF NECROPSY: 10/01/98 11:13 POST-FIX WEIGHER: NOT AVAILABLE pa?hOLOGISTT0^ H N AEIGHMY 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 NOT TAKEN 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 WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN appendix 6 individual Anatomic Pathology Data Covance 6329 225 3M T-6314,1 13-w e e k d i e t a r y t o x i c i t y s t u d y n -m e t h y l ETHANOL (N-MEFOSE.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 PAGE: 81 FIRST INTERIM SACRIFICE ANIMAL NUMBER: C95954 SEX: MALE ; o ST,? DOSE GRO0SPT:UDY3 WEE_K OF DEATH: 5 _ S S ^ B ot RECORDER: T S iS S KEVIN TB-IL'LI3 N" GS- 4 WEIGHER: MICHELE ZIMA ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) t h y r o i d /p a r a t h y r (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 ^ R O P S Y : _ BONE. (SM) (b i ^ i d n ^ ' i k d k S i ( ^ TM f c U s k e l e t a l HBONE, FEMUR SPINAL CORD (FE) , (SC) , LUNG (DU) , mpAPHEA (Tr THYMUS ),(TEH)SOPHLAN,GUSMMEESS(EEENSN)TTEE,RRIDICICVE7(RMm^.s) , THYROID UTYK ql^ S tI?0s t o m a c h ! NONGL (SUK (AO), PITUITARY ( ROTUM (RE). LN, MANDIBULAR (MNK ADRENAL?CCORTEX`1AC).SADRENAL. MEDULLA (MA) , O R T A -CS S S ^ S ) . '`P> ' SALIV UL, SEMINAL VESICLES^ (SV) TTS (TE) EPIDIDYE ________ 369 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 1lJ3--WWfcE.EnKK DUlIEiTAAiRuY TiwO.XICITY ^ U D Y WITH N-METHYL PAGE: 82 SCHEDULED, FIRST INTERIM SACRIFICE qpv. MALE DOSE GROUP: 3 SACRIFICE STATUS: TERMINAL BODY WEIGHT: 346.9 GRAMS ANIMAL NUMBER: C95955 It U D Y ^ A Y OF DEATH: 31 STUDY WEEK OF DEATH: 5 DATE OF DEATH: 10/01/98 11.55 PROSECTOR: TONY HANFELD DATE AND TIME OF NECROPSY: 10/01/98 PATHOLOGIST: JOHN EIGHMY RECORDER: KEVIN BILLINGS WEIGHER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE --------------------- ORGAN NAME ^ _________________ ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) 15.0803 4.3472 % NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THYROID/PARATHYR (TT) PANCREAS (PA) 7 DUODENUM (DU), JEJUNUM (JE), I L H 5 ) 'SKIN SK) , RINARY BLADDER (UB) , PROSTATE . ------------------------- 370 appendix 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-lmf-fCiTTlHyYlLX TM PATS nnunnf'TAtrafim.FOIlAMIDO ETHANOL (N-MEFO0* Covance 6329-225 3M T-6314.1 PAGE: 83 ANIMAL > . 5956 OF DEATH : SS" "" S i < S l 5 f iP * TM ' S S S d" S `o F h S?PSY, 12/02/98 8,2, ,,BIGHE, POST-FIX WEIGHER: NOT AVAILABLE -- ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0526 2.1420 3.8586 17.4646 .7985 2.7847 .3131 .0268 ------------ ORGAN WEIGHT RELATIVE ORGAN TO BRAIN TO BODY WEIGHT (%) WEIGHT RATIO -- .4093 % .7374 % 3.3374 % .1526 % .5321 % .0598 % .0051 % .0246 1.0000 1.8014 8.1534 .3728 1.3000 .1462 .0125 OB SERVATIONS HISTOPATHOLOGY NECROPSY ___________ STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN " H ypertrophy, hepatocellular centrilobular,-minimal -INFILTRATE, LYMPHOHISTIOCYTIC, MINIMAL GENERAL COMMENT (GC). : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 371 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYLi\ TIT T3ATC Tir\T3r\rr*fPAMT?cnT.,P,nNAMTDO ETHANOL (N-MEFOSE PAGE! 84 nnC;r RBnnp, 3 SACRIFICE STATUS: ANIMAL NUMBER: C95956 DATE OF DEATH: 12/02/98 It h ^ D A Y OF DEATH- 93 STUDY WEEK OF DEATH: 14 STUDY DAY OF DEATHpR^ ECTQR; MICHELE ZIMA DATE AND TIME OF ^CROPSY: 12/02/98 8.27 PATHOLOGIST: JOHN EIGHMY POST-FIX WEIGHER: NOT AVAILABLE ________ ,,-----I______________________________ SCHEDULED. TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 523.3 GRAMS RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER , ^ , H 2 S r ,H f f i k l ^ S D <S i . ITM T S , B 9 I, (fl.'SKI M l . !SS` : . .l w . THE FOLLOWING TISSUES WERE OTREMARKAEL^ AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) |0B'- TM 0ST" E 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: 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 373 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: 8 6 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) 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 ANIMAL 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 DATE 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 375 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 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 471.3 GRAMS DATE 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 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) 376 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: 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 LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED GENERAL COMMENT (GC) : -BONE MARROW SMEAR'TAKEN LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL 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: 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) 378 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0760 2.1953 3.8855 16.2467 .6429 3.8243 .1769 .0243 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0169 % .4883 % .8642 % 3.6136 % .1430 % .8506 % .0393 % .0054 % ORGAN TO BRAIN WEIGHT RATIO .0346 1.0000 1.7699 7.4007 .2929 1.7420 .0806 .0111 ORGAN STATUS 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 379 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: 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) 380 jr*- 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: 93 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 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 381 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 (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) 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 383 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) 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: 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 ADRENAL .(AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0519 2.0730 3.9593 26.0579 .6285 3.4019 .2799 .0246 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0110 % .4381 % .8367 % 5.5067 % .1328 % .7189 % .0592 % .0052 % ORGAN TO BRAIN WEIGHT RATIO .0250 1.0000 1.9099 12.5701 .3032 1.6411 .1350 .0119 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS H ISTOPATHOLOGY 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, 1 MM IN DIAMETER 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 385 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 GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN O B S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY 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 (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, 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) 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0554 2.2840 4.5315 30.5553 .7488 3.8137 .2714 .0220 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0120 % .4934 % .9789 % 6.6008 % .1618 % .8239 % .0586 % .0048 % ORGAN TO BRAIN WEIGHT RATIO .0243 1.0000 1.9840 13.3780 .3278 1.6697 .1188 .0096 ORGAN STATUS 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 -NECROS IS, 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 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: 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) 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: 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 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) .0569 2.1026 4.2312 24.8958 .5544 3.5478 .2759 .0214 .0135 % .4984 % 1.0029 % 5.9009 % .1314 % .8409 % .0654 % .0051 % .0271 1.0000 2.0124 11.8405 .2637 1.6873 .1312 .0 10 2 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATION S 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. 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: 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 T IM E 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) APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY TH N-METHYi LA \ TXT T> r p a ,,,,,,,,r Tmufi^sHBCiir.uilNAMIDO ETHANOL (N-MEFOSE PAGE: 103 SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C95966 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: cv. MALE DOSE GROUP: 4 SACRIFICE STATUS: STUDY^DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 __ 7 . 5 3 PROSECTOR: KEVIN BILLINGS 12/02/98 PA T H O LO G IST : JOH N EIGHMY TERMINAL BODY WEIGHT: 444.3 GRAMS RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/ PARATHYR (TT) E ORGAN WEIGHT (GRAMS) .0524 2.0426 4.8321 20.9821 .7381 3.0674 .3532 .0227 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0118 % .4597 % 1.0876 % 4.7225 % .1661 % .6904 % .0795 % .0051 % ORGAN TO BRAIN WEIGHT RATIO .0257 1.0 0 0 0 2.3657 10.2723 .3614 1.5017 .1729 .0 111 STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN OB SERV ATIONS H IST O P A T H O L O G Y NECROPSY ^ M IN E R A L IZ A T IO N , V A SC U LA R ,-M IN IM A L 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 , - s l ig h t -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 PA T O C Y T E ,-M IN IM A L THYMUS (T H ) : -H EM O R R H A G E ,-M IN IM A L LN , M ESEN TER IC (M S) : -H EM O R R H A G E ,-M IN IM A L TH YROID (T Y ) -C Y S T , U LTIM O BRAN CH IAL, -P R E S E N T URINARY BLADDER (U B) : ____ __________ GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 391 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL nnrmr'Tiirasnt.KrMMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 104 Sc Ai oCRp tIfFtIOCEF SSTTAATTUUSS: SCHEDULED,QTDEYR,,MEIINGAHLT:SACRI4F44I.C3E GRAMS ANIMAL NUMBER: C95966 DATE OF DEATH: 12/02/98 OF DEATH- 9 3 ^ GRSTUDY WEEK OF DEATH: 14 STUDY DAY OF DEATHpR" ECT0R;SKEVIN BILLINGS RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 7.b PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE _______ ________________________________ s r TM , i " >-Ii" s - (s r s ! ! D S , ( " a ik * . <> a.nRFMAT, CORTEX (AC) ADRENAL, MEDULLA (MA) , AORTA (AO) ' I ) ^ x S o S , : * l ,sm. RECTUM (RE), LN, MANDIBULAR (MN) , SEMINAL^VESICLES (SV> , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) I S fg . (IS1 STOMACH, GL (ST), S^ CH/ | ALIV GL^ MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), ______________________________ APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITM N-METHYL TM,,,,,T,TMnnnmiNRSTlT,FnNAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 105 SA C R IFIC E STA TU S: ^ D U L E D , ^ E R M N A L ^ A C R IF IC E ^ ANIMAL NUMBER: C95967 DATE OF DEATH: 12/02/98 omnnv^AY OF DEATH- 9 3 ^ ^ ^ T U D Y WEEK OF DEATH: 14 STUDY DAY OF DEATHpR^ CT0R: MICHELE ZIMA DATE AND TIME OF NEEROPSY: 12/02/98 9.54 PATHOLOGIST: JOHN EIGHMY POST-FIX WEIGHER: NOT AVAILABLE ^ _ ____________________________________ ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT ) ABSOLUTE ORGAN WEIGHT (GRAMS)' .0473 2.1398 4.1495 25.0600 .4205 3.2710 .1537 .0278 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0106 % .4778 % .9266 % 5.5962 % .0939 % .7305 % .0343 % .0062 % O B SERVATIONS NECROPSY R E C O R D E R : WENDY CH ERRY W E IG H E R : LYNN HORNER ORGAN TO BR A IN W EIGHT R A T IO ORGAN STATUS .0221 1.0 0 0 0 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 HISTOPA TH OLOG Y KIDNEY (KD) : -LARGE PELVIS(ES) ; LEFT THYMUS (TH) : -DIFFUSELY RED; RIGHT LOBE IN F IL T R A T E , MACROPHAGE, ALVEOLAR, -M IN IM A L 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 derate - P I G M E N T , H E P A T O C E L L U L A R ,- M I N I M A L ____ A TIO N HEPATOCELLULAR, D IF F U S E , SLIG H T >N O TE>PIG M EN T I S CONCENTRATED IN THE CYTOPLASM OF CEN TRILOBU LA R HEPATOCYTES NEAR B IL E C A N A L IC U L I. KIDNEY (KD) : -D IL A T A T IO N , P E L V IC ,-S L IG H T THYMUS (T H ) : -H EM O R R H A G E ,-M IN IM A L -IN V O L U T IO N , -M IN IM A L TH YROID (TY ) s -C Y S T , U LTIM O BRAN CH IAL, - PRESEN T PITU ITA R Y ( P I ) : -C Y S T ,-P R E S E N T 393 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL a \ Tw nume t-.wtvc?tTincnr\r*fraKraSTTT,FONAMIDO ETHANOL (N-MEFOSE fT1" PAGE: 106 ANIMAL NUMBER: C95967 DATE OF DEATH: 12/02/98 POST-FIX SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE cmnv'niv OF DEATH- 93SE ^ S T U D Y WEEK OF DEATH: 14 STUDY DAY OF DEATH^R" E C T Q R S^ CHELE ZIMA TERMINAL BODY WEIGHT: 447.8 GRAMS RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER PATHOLOGIST:_JOHN_EIGHMY____________ -- NECROPSY LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED O S S E R V A T I O N S (CONTINUED) HISTOPATHOLOGY LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT PROSTATE (PR) -INFILTRATE, : __ LYMPHOHISTIOCYTIC, -MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN muD the Ff Oo Ll lLOo Ww Ii Nn Gg ^Ou Rk GgaA^NS WEmRaErboUwN>REMf Ae RmKuArBL(Ef mA)Ti NmEaCrRr Oo Pw S,Ys:t e r n u m (SE)., QBnO,TI]E?' tS-'TT'FERRNNIUIMMa ^(SSB)B., E^YE (EY) , BRAIN skele (BR) tal ,(SM), SPINAL CORD (SC) , LUNG (LU) , TRACHEA (TR) , JjSOPHASUS )' . PARATHYROID (PT) , ADRENAL, CORTEX (AC) , NErX SCIATIC (SN). SPLEEN (SP), ^ T E R I C (MS^JHYROID (TY) , ^ R A T H Y R O ^ ^ I^ ^ PANCREAS (PA) . S S S i `S U , J( S r a (k).ADRENAL, MEDULLA (MA) , AORTA (AO) , ^ M ^ C E C U M (CE) COLON (CO), RECTUM (RE), SALIV GL, MANDIB <SG) * ,qv) URINARY BLADDER (U.) , PROSTATE (PRI. SEKINAl VESICLES (SV). TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE NRE^RKABLE AT "^ROSCOPI^XAMINATION^ BONE, FEMUR (FE), MARROW, FEMUR (FM) MARROW, STERNUM SE ^ (SB), EYE (EY) , BRAIN (BR), SKELETAL (SM) , NERVE, SCIATIC (SN) , i s <5aTM ssrw : s ^ r ^ c r COLONCi(CO?L IcT{mS (RO?H^ " L , <STM f (SG), HARDERIAN GLAND (HG) , SKIN (SK) , URINARY BLADDER (UB) , SEMINAL^VESICLES (SV) , TESTIS (TE) , EPIDIDYMIDES_ (EP)____________________________________________________________ APPENDIX 6 Individual Anatomic Pathology Data 13-W E E K D IE T A R Y T O X I C I T Y S T U D Y W IT H N -M E T H Y L v*.T nRiTC M r a n w 'i n i H B m i T . l 'n N M I D O ET H A N O L (N - M E F O S E , T-6314) Covance 6329-225 3M T-6314.1 PAGE: 107 Is m -- ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR ST " W - i F " " m (TT) TM 9158 absolute organ weight (GRAMS) .0730 2.1136 4.2887 24.0192 .9478 2.8087 .2901 .0236 ___________- -- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO .4600 % .9333 % 5.2272 % .2063 % .6113 % .0631 % .0051 % .0345 1.0000 2.0291 11.3641 .4484 1.3289 .1373 .0 112 _ 0B S E R V A T I O N S HISTOPA TH OLOG Y n ec r o psy " " s STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN ^ I N F I L T R A T E , MACROPHAGE, ALVEOLAR, M INIM A L " S r w * . HEPATOCELLOtM:, CBNTRILOBUUIR.-MODBMTE :5 S S S S S , ,,S S ; S S S S S S " u >m t o m m m u . M INIM AL AD- TM F l L T ^ T E EX LY M PH O H ISTIO C Y TIC , -M IN IM A L unnem A TE (P R ) : _________ GENERAL COMMENT (G C ) : -B O N E MARROW SMEAR TA K EN -M A LO CCLU SIO N ; BILA TERA L U PPER IN C ISO R S 395 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL nr.TTTAnrviv'iPiKis'cnT.pnMAMTDO ETHANOL (N-MEFOSE, T 6314) PAGE: 108 / S S ; S5SS5. S i- 1 ? of dTM, _ ____ , e a n o T P T r i ? STATUS- SCHEDULED, TERMINAL SACRIFICE 14 ! i s . s s & TM _______________ ------------------------------------------- f " " L S S tt? U . n " " piSV ( S r s - s 1, ^ a '(THI. u>. S ? m R i 5 IS ' ( TM " ?o S h : X " TM <>. '?o , E : k o m s l (sut. SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE SPINAL CORD (SC), TRACHEA (TR) , JSSUrnAuua ih /, (SB), EYE (EY) , BRAIN (BR) , MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), ' PARATHYROID (PT) , ADRENAL, MMEDEDULULALA (M(AM;A,),suAO*RTA (AO), i s f i k r s s - s : - - a u d i t o r y ^seb^gl^(a s )"^ skin^ s k )^ u r i n a r y b ^ d d e r ^ u b I ^ s e m i n a l ^ v e s i c l e s ^ ^s v ) ^ ^ t e s t i s tej^ ^ e p i d i d y m i d e s ^ e p )^------------------- 396 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITM N-METHYL TXT nonrn nnDrwTANKfinLFONAMIDO ETHANOL (N-MEFOSE, T 6314) Covance 6329-225 3M T-6314.1 PAGE: 109 =>,, I" iv"S ? or DEATH1 5 T WEEK o f S S S f i s s . /S S s .r " " i a s a ,i * s a s s r - POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0691 2.0668 5.0360 22.5076 .7573 3.3886 .2489 .0252 .0148 % .4437 % 1.0812 % 4.8320 % .1626 % .7275 % .0534 % ___ OBSERVATIONS NECROPSY f S f S r ^ S P 0! <*AS ________ ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS .0334 1.0000 2.4366 10.8901 .3664 1.6395 .1204 . 0122 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN HISTOPATHOLOGY -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL IvACUOLATIONh"HEPATOCELLULAR^YCENTRILOBULAR TO MIDZONAL,- KIDNEY (KD) : -LARGE PELVIS(ES); RIGHT ST-DARk 'FOCUS m/AREAS) ; MUCOSA: MULTIPLE DARK BROWN AREAS, UP TO 2 X 1 MM MINIMAL KIDNEY (KD) : -DILATATION, PELVIC,-MODERATE HEART (HT) -DEGENERATION/NECROSIS ,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL STOMACH, GL (ST) : -EROSION, -MINIMAL P R - I N F I L T R A T e ! LYMPHOHISTIOCYTIC,-SLIGHT 397 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-2: 3M T-6314 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL T , r v n n T r G T i T . phtjamtDO ETHANOL (N--MEFOSE, T-6314) PAGE: 110 ANIMAL NUMBER: C95969 nATE OF DEATH- 12/02/98 ___ _ , cif'oTPTrp STATUS: SCHEDULED, TERMINAL SACRIFICE SEX: MALE DOSE GROUP: 4 DEATH: 14 TERMINAL BODY WEIGHT: 465.8 GRAMS STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH. 14 RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 11:41 POST-FIX WEIGHER: NOT AVAILABLE NECROPSY PPRA2THS.O?L9OTMG?ISiT,,:JE^JOhHSN EIGHMY O B S E R V A T I O N S (CONTINUED) WEIGHER: LYNN HORNER HISTOPATHOLOGY PROSTATE (PR) : -INFLAMMATION, CHRONIC-ACTIVE, -MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN THF FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: THE bSn e ? FEMUR (FE), MARROW, FEMUR (FM) , MARROW. TM U M SPINAL CORD (SC) , LUNG (LU) , TRACHEA (TR) . ESOPHAGUS ,, STERNUM (SB), EYE (EY) , BRAIN (BR) , (SB) , B^E . STE RS ^ i S B, (SM) , , Liv V THyR0ID (TY) _ PARATHYROID (PT) , " S A R D S ' ( H ^ TM f s E B G i (AS), SKIN (SK) . URINARY BLADDER (UB, . PROSTATE (PR). SEMINAL^VESICLES (SV)! TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) SPINAL CORD (SC), LUNG (LU) , TRACHEA ITK) , EYE (EY), BRAIN (BR), w~) , NERVE, SCIATIC (SN) , SPLEEN (SP) , " m R T E X (AC) ADRENAL, MEDULLA (MA) , AORTA (AO), ^iv (AS,, SKIN^ (SK^l *URINARY BLADDER^ (UB^^SEMINAL VESICLES^^(SV^^TESTIS^^TE^ ^EPIDIDYMIDES^^(EP)^_________________________ APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WTTH N-METHYL n A \ T A \ I T T V 3 n m u x M A T . /M --MT^T**OE. T-6314) PAGE: 111 cpv. m a l e ANIMAL NUMBER: C95970 DATE**Of"DEATH : 12/02/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 12/02/98 8.47 _vir r.TnT/*<tiT3D MOT* IVlTT.AHLh. SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE DOUKSE lGiRiOtuUuPr:: *4 ------- ,, . TFRMTNAL BODY WEIGHT: 439.7 GRAMb STUDY WEEK OF DEATH: 14 PATHOLOGIST: JOHN EIGHMY ___ ----------"-- WEIGHER. _TUNY nan-------------. . ---------------------- ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0560 2.2490 3.7296 23.2250 .6436 3.5189 .2718 .0230 .5115 % .8482 % 5.2820 % .1464 % .8003 % .0618 % .0052 % O BSE RVA T ION S WEIGHT RATIO .0249 1.0 0 0 0 1.6583 10.3268 .2862 1.5647 .1209 .0102 STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN HISTOPATHOLOGY NECROPSY 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 derate -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL LN, MANDIBULAR (MN) : -MOTTLED; BILATERAL: DARK RED AND TAN GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN T1I,,r m D , -MALOCCLUSION; BILATERAL UPPER INCISORS^ : S sii: S C , - m in im a l -PIGMENT, HEPATOCELLULAR, -MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL " S ' CHRONIC -ACTIVE,-MINIMAL -PIGMENT, BROWN,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE, -MINIMAL 399 APPENDIX 6 individual Anatomic Pathology Data C ovance 632 9 -2 2 5 3M T - 6 3 1 4 . 1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PFRFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 112 M VUJ. C95970 SEX, MALE EE EACRIPICE STATUS, " S S " URX.S a s s . - s f f c i 'iS i S . 1 . / S 5 POST-FIX WEIGHER: NOT AVAILABLE _______________ W"EIGHER: TSONIBY,EHATMNFEL"D ES," S THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY) , BRAIN (BR) , b o n e , FEMUR (FE), m a r r o w , f e m u r (FM), a r r o w , s t e r n u m (SE) b o n e , s t e r n u m ^ :I HEART m u s c l e , s k e l e t a l (SM), SPINAL CORD (SC) , LUNG (LU) , TRACHEA (TR) ' ^ O P M G U S IES) , LIVlLK i,^ ^ PARATHYROID (PT) , NERVE, SCIATIC (SN) , SPLEEN (SP), THYMUS (TH),LN, MESENTERIC ^MSK s t o ^ACH, GL (ST), STOMACH, NONGL (SO). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO) , PITU COLON (CO), RECTUM (RE), SALIVGL, MANDIB (SG) , \IV)',S R l L ' G ^ D T G ^ i T ^ Y i E ^ S K I ^ S K ^ ' u r S y 'b ^ D E R (UB) , PROSTATE (PR). SEMINAL VESICLES (8V). TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE NERVE ADRENAL EPIDIDYMIDES (EP) DUODENUM (DU), HARDERIAN GLAND (HG), (SV,. TESTIS (TE,. _____________________________________________________ 400 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL TitjQtrrtinonnrTaNERm.FONAMIDO ETHANOL (N-MEFOSE, T 6314) PAGE: 113 _, otroTVTrp STATUS- SCHEDULED, FIRST INTERIM SACRIFICE f A ^ F N= ; I f i l D s * DATE AND TIME OF NECROPSY: 10/01/98 11:57 PATHOLOGIST^JOHN EIGHMY ^ ^ '" r^ I """ WEIGHER: MICHELE ZIMA__________ POST-FIX WEIGHER: NOT AVAILABLE ____ ________________________________________________________ ORGAN --------------------------------- A ^ L U T e 'o RGAN WEIGHT ORGAN NAME <TM) ORGAN WEIGHT RELATIVE TO BODY_WEIGHT (%) ^^H^RATIo" WEIGHT_RATIO 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 W'EERREE_UNREMARKABLE^AT NECROPSY: CTERNUM (SB). EYE (EY) , BRAIN (BR) , FEMUR (FE) MARROW, FEMUR (FM) < STERNUM (SE) , BONE, (KD) _ HEART (HT) , MUSCLE, SKELETAL (SM) NONGL (SU), MANDIBULAR (MN), PROSTATE (PR), (ivi : s ^ e^ ^ ^ ^ iSe s ^ e p k 401 a p p e n d ix 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY ^ ^ N - M E T H Y L mDnnnn>iHB5 ni.mNAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 114 TM R : C95972 SHX: M A - S K 5ANDt IME:OFn ECROPSY: 10/01^98 12:06 , - E GROUP:^ ^ csrPTSTfP STATUS SCHEDULED, FIRST INTERIM SACRIFICE SC WEIGHT: 333.3 GRAMS WEIGHER^ MICHELE^ZIMA__________ POST-FIX WEIGHER: NOT AVAILABLE ______________________________________________ "I-TM TM " --------------------------------- ^ Z OTE = WEIGHT ORGANoWEIGHTgRELATIVE ORGAN^O^ ORGAN 8 TATUS ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) (GRAMM 14.9723 ------4.4921 % ------- NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE " IT. (sf!i t ^ r ^ ^ S s t - ,sr^?asa: r e r S o S : -- AiDiTMr rnRTEX (AC) ADRENAL, MEDULLA (MA) , AORTA (AO) * pot ON (CO) RECTUM (RE) , LN, MANDIBULAR (MN) , PANCREAS DTOd U m DU) ,_JEJUNUMJJE) , (IL) .^ E C U M 'SKINI(SK)?>URINARy"BLADDER (UB) , PROSTATE (PR), ISslf ss : _________ APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL rn n t v Ti c m .PONAMTDO ETHANOL (N-MEFOSE PAGE: 115 cacPTVTPF STATUS* SCHEDULED, FIRST INTERIM SACRIFICE ANIMAL NUMBER: C95973 SEX: MALE DOSE GROUP: 4 0F dIIt H DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 31 ^Snv^uFnnv 10/01/98 11:48 P A T H O L O G IST : JO H N EIGHMY P O S T -F IX W EIGH ER: NOT A VA ILA BLE 5 ORGAN NAME ABSOLUTE ORGAN W EIGHT (GRAM S) ORGAN W EIGHT R E L A T IV E TO BODY W EIGHT (% ) TERMINAL BODY WEIGHT: 276 7 GRAMS RECORDER: KEVIN BILLINGS WEIGHER: MICHELE ZIMA ORGAN TO BRA IN W EIGH T R A TIO ORGAN STATUS NOT TAKEN ADRENAL (AD) BRA IN (BR) K IDN EY (KD) LIV ER (L I) SPLEEN (SP) T E S T IS (TE) THYMUS (T H ) 13.1995 4.7703 % NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THYROID /PARATHYR (TT ) THE FOLLOW ING ORGANS WERE UNREMARKABLE AT N EC R O PSY : S W FEMUR ( ^ , ^ R R O r = ^ ^ ^ r ^ O P ^ t ^ STERNUM ( S B ) , EYE (E Y ), '- L ^ ^ L I ^ D ^ ' i K D ? & & BR A IN 7h T) (B R ), MUSCLE, SKELETAL (8 . ISP) , THYMUS (TH) , LN, MESENTERIC (Mb), la s t o m a c h GL (ST), STOMACH, NONGL (SU) , ADRENAL 'CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO ' ^ TM I T A R Y C O L O N ^ C O K RECTUM (RE), LN, MANDIBULAR (MN); ApPDaATNCrR^EAS ^PA), DUODENUM (DU), JEJUNUM (dJE), '!Lf r (IL> SEB^GL^ (AS^ "SKIN^SK), URINARY BLADDER (UB) , PROSTATE (PR, i i l GLLk = l S i : __________ 403 appendix 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 nm-ifrTT/^n1r3^-rvW^ErEnAKvrpDcITETTT.AFRnNYAMITDOOXIECTIHTAYNOLSTU(DNY-MWEIFTOHSEN-METcHaYi^L\ TM BITS PAGE: 116 . c i p q t p t p p STATUS' SCHEDULED, FIRST INTERIM SACRIFICE ANIMAL NUMBER: C95974 DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: SEX: MALE STUDY DAY OF 10/01/98 11:22 DEATH: DOSE 31 GROUP; 4 STM X 0F d Ia TH 5 n TERMINAL BODY WEIGHT: 311.4 GRAMS RECORDER: KEVIN BILLINGS ____,,EIGHER: _MICHELE_ZIMA__________ POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) 14.4142 4.6288 % NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THYROID/PARATHYR (TT) PSSCRS (PA). DUODmUM (DU). !" >: ^ Si) ^AUdth y 'SEB~Gl""(AS) ' SKIN (SK> , <*> ------------------------- APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL ^ o -i 4 v r x i TJ A r n o nntjnru-TiTvTOHnT.pnNAMIDO ETHANOL (N-MEFOSE fp- PAGE: 117 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE ANIMAL NUMBER: C95975 DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: npy. MALE DOSE GROUP: 4 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 10/01/98 11:53 PROSECTOR: MATTHEW AXTMAN PATHOLOGIST: JOHN EIGHMY 5 TERMINAL BODY WEIGHT: 327.4 GRAMS RECORDER: KEVIN BILLINGS WEIGHER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) 16.4042 5.0104 % NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THYROID/PARATHYR (TT) S "' : ' m u . l. '(STSoSS: SHSrKoiE,: l<*. ADRENAL, CORTEX (AC), ADRENAL, MEDULLA <MA) , AORTA ( ), (CE) COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), PANCREAS (PA), DUODENUM ^U) . JEJUNUM (JE), Eb g l (AS) ,'SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), I S i L f w X K !I5!: ____________ 405 A PPEN D IX 6 I n d iv id u a l A n a to m ie P a th o lo g y D a ta C ovance 6 3 2 9 -2 2 5 3M T - 6 3 1 4 . 1 13-WEEK DIETARY TOXICITY STUDY N-METHYL nrtnr>A^mKiT?cm.pnMAMTr)n ETHANOL (N-MEFOSE _m f i l i TXT U T V Q PAGE: 118 ANIMAL NUMBER: C95976 DDAATTEE OurF DDEEjAtTmH.: 12/02/98 SEX: MALE STUDY DAY OF DEATH: DOSE 93 GROUP: 4 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 n/no/aa a.03 PROSECTOR: JJJI-LLL fPAAuUoS DATE AND TIME OF NECROPSY: 12/02/98 8.23 PATHOLOGIST: JOHN EIGHMY RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER ORAHS ---------------------ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0447 2.1994 3.5516 21.3634 .4872 3.4775 .2380 .0300 .5746 % .9278 % 5.5808 % .1273 % .9084 % .0622 % .0078 % OB S E RVATIONS NECROPSY ORGAN TO BRAIN WEIGHT RATIO .0203 1 .0 0 0 0 1.6148 9.7133 .2215 1.5811 .1082 .0136 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 Iv A C U O L A T IO N ^H E P A T O C E L L U L A R ^^E N T R IL O B U L A R TO M IDZON A L. MINIMAL THYMUS (TH) : -HEMORRHAGE, -MINIMAL THYROID (TY) -CYST, ULTIMOBRANCHIAL,-PRESENT LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT appendix 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITM TN R w g PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 119 ANIMAL NUMBER: C955997766 STUDY^DAY OF DEATH: " " ^ "sTODY WEEK o f TM - '^ DATE OF DEATH: 12/0022//99a8_ _ "ps!-2,3,* DATE AND TIME OF NECROPSY: 12/02/98 8.23 PPRROOSSEECCTTOORR:: JJIILLLL PPAAUUSS PATHOLOGIST: JOHN EIGHMY POST-FIX WEIGHER: NOT AVAILABLE E f H E R ^ GRA"S WEIGHER: LYNN HORNER SKELETAL (SM) ' I f E 1 a s a r - S i S . s r s i S ------------ 407 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WI^H N-MET Hn Y1 La \ T M n & T .Q TTrmru-u^n'aMF.snT.FONAMIDO ETHANOL (N-MEFOSE PAGE: 120 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 454.6 GRAMS ANIMAL NUMBER: C95977 DATE OF DEATH: 12/02/98 etrrTnY^DAY OF DEATH- 9 3 ^ GRSTUDY WEEK OF DEATH: 14 STUDY DAY OF DEATHpR^ ECT0R; MICHELE ZIMA RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 10.5H PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE____ ________ _________________________________ ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0587 2.0929 4.2673 25.0541 .7871 3.4440 .2202 .0339 .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 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN O B SERVATIONS HISTOPATHOLOGY NECROPSY 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 ^ -INFILTRATE, MACROPHAGE, ALVEOLAR, MINIMAL LIVh y p e r t r o p h y HEPATOCELLULAR, CENTRILOBULAR,-MODERATE Iv Ic UOLMION; HEPATOCELLULAR, DIFFUSE,-SLIGHT HEART (HT) i -DEGENERATION/NECROSIS,-MINIMAL THYMUS (TH) : -HEMORRHAGE, -MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL ______ voMUMTno ETHANOL (N-MEFOSE, T-6314) Covance 6329-225 3M T-6314.1 PAGE: 121 ANIMAL NUMBER: C95977 ^EX.^MALE DEATH. --9 3 w e ek o f s i s f i r TM si DATE OF DEATH: 12/2/98 STUDY 10.5g PROSECTOR: MICHELE ZIMA DATE AND TIME OF NECROPSY: 12/02/98 10.58 PATHOLOGIST: JOHN EIGHMY POST-FIX WEIGHER: NOT AVAILABLE _______________________ RECORDER: WENDY CHERRY -- WEIGHER: LYNN HORNER N P R V E SCIATIC (SN), SPLEEN (SP) , LN. MESENTERIC (MS) .THYROID TY , & JE T " NQN^L (su) , PANCREAS (PA), TESTIS (TE) , EPIDIDYMIDES (EP) , TAIL (TI) ------------ 409 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL T%YT.TiT*rTT/-r>rw"'rraMT?CT7T.T7ntJAMTnO ETHANOL (N-MEFOSE, T 6314) PAGE: 122 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C95978 OF DEATH- 9 3 ^ GRSTUDY WEEK OF DEATH: 14 ^ T M E :OF2 NECROPSY- 12/02/98 T i O ^ PROSECTOR: Z l N BILLINGS TERMINAL BODY WEIGHT: 454.2 GRAMS RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER ?o!t - ^ x w e i g h e L n S a v Ii l a b l e ' __________ PATHOLOGIST:_JOHN_EIGHMY________ ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0568 2.1377 3.6874 28.4115 .6243 3.8868 .1836 .0245 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0125 .4707 .8118 6.2553 .1375 .8557 .0404 - 0054 ORGAN TO BRAIN WEIGHT RATIO .0266 1.0 0 0 0 1.7249 13.2907 .2920 1.8182 .0859 .0115 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY jUNG (LU) : -MINERALIZATION, VASCULAR, -MINIMAL LI-VELLIRAGTHETR(ALIFL)OCLUO:SBE(:I)/MAURLETAI(P,SL)E,;TADNIAARPEHARSA,GMAPTIINCPOISNUTRFAANCDE OF UP LEFT TO 1 MM IN DIAMETER; COLLECTED ON ROUTINE SECTION 1 -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, COAGULATIVE,-SLIGHT -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL, - SLIGHT IHYMUS (TH) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PROSTATE (PR) :_____________ __ GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN APPENDIX 6 Pathology Data i n d i v i d u a l Anatomic s t u d y w i t h ^n -m e t h y ^ in DOSE GROUP ,,EEK OF DEATH: f " 4^ H cO'! o s ^STUU_ ^ S- DATE OF DEATH: 12/02/908pSY5 1122//U022//3908 8:40 -p -a T-H-O--L-O-G-1S-T-:---JO-H-N--E-l-i-*----_---- bone, femur ' l u n g (l u ). - ,,n\St h wy m Mu s (viTnH')>,^--N,; Pi t u 'i%'- SPINAL 'CSCIATcC\sN) . S P ^ PU u u i r U n ' i o R T k Si1 ^' SPINAL SSTOSi sSiB_fGL_e(M)._S&TM.:A Covance 6329-225 3M T-6314.1 PAGE: 123 TERMINAL_SACRIFICE g r a m s ,,r a in (BR) . <*' APPENDIX 6 Anatomic Pathology Data individual Covance 6329-225 3M T-6314.1 PAGE: 124 K.FUJ0BOOCTMBS _________________________ - - ___ ___________________ ____________________ _____B ! e,W X S . SACRIFICE STATUS: S C H ^ QDY W E ^ ^ ADESTINE ------------------------^ ^ O F ^ T H : 12/02/98 SEX! MALE fatH; SE GR0STDV OFch S ! U 35^'" |TUDY " fllf " pATHOLOGIST^ JOHN EIGHMY------- ------stV tV s ___________ -------- --- ------------------------ ADRENAL (AD) BRAIN (BR> K ^NE Y (KD) LIVER (DI) SPLEEN SP) (g r a m s >_ '7 ;! ?' ggil 079324 ^3'6649 3.4924 2278 " 0115 % -SJUi 5`.3408 % .1529% .8029 % .0524 % .0058 1.0000 WEIGHT TAKEN 38 .2941 S S WEIGHT TAKEN 1.5448 .1008 WEIGHT TAKEN WEIGHTJTAKEN .0112_______________ ______________ M z & = ^ N-EC-R-O-P-SY----__-_^_______.__._._.____ ___________________________ DIVER <" ) ^ HEPATOCELLULAR^ C ^ : S S ! S TM i S S f f l S 5 t e ' - BlI" r THYS u l t i m o b r a n c h i a l .-p e e s e n aUS R e ^ w e d .-f k e s e t e r a l COFMENt (GC) t a k e n " SI. 0N ? - - - 412 appendi^ 6 Pathology Data i n d i v i d u a l Anatomic S?SI " & S * x It u d y ^ a y o f d e a t h W o3s e c t o r :0lIu r x e DATE of 12/02/98 DEATH. np~NECROPSY: 1122//u02./98 8.16 PATHOLOGIST. 0 DATE AND TIE,,R N ^ AVAILABLE fc,, S S ` Covance 6329-225 3M T-6314.i PAGE: 125 TEEMINALJACRIFICE grams 5SS5i" ': 5 " !?" _____ BRAIN (BR) < L (SM) w qALlV GL, h M TESTIS <TsE), SEMINAL VESICLES (SV), , S . INGG TISSUES FEMUR lFM) ' 5 X SCIATIC JS W Jfc. m n M ESOPHAGUS lEb)' ^r- (MSI PARATHYKUiu * i m ) , PANCREAS u " # 2S: w s w APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL />nAru*im\Ti'om.i?mjaMTnn FTHANOL (N-MEFOSE, T--b / PAGE: 126 ANIMAL NUMBER: C95980 DATE OF DEATH: 12/02/98 SEXtMALE SACRIFICE STATUS: DEATH. ^ SE GRsTUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 434.0 GRAMS STUDY DAY OF DEATHpR" ECT0R;bKEVIN BILI)INGS RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 12.24 PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE ^ ___________________________ --------------------------------- --" o r g a n 'w e i g h t (GRAMS) ORGAN EIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS ORGAN NAME 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 .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 OBSERVATION S HISTOPATHOLOGY NECROPSY H y p e r t r o p h y , h e p a t o c e l l u l a r , c e n t r i l o b u l a r ,-m o d e r a t e -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE, -MINIMAL AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 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: 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) 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: 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 STA TU S 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 % .6713 % .8742 % 3.8353 % .0327 % .3247 % .0984 % .0083 .0444 1.0 0 0 0 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 416 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: 12/02/98 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 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 (SM), 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) 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) 417 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: 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 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: 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) 419 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0677 1.8357 2 .12 11 7.7858 .1169 .4244 .2297 .0160 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0303 % .8206 % .9482 % 3.4805 % .0523 % .1897 % .1027 % .0072 % ORGAN TO BRAIN WEIGHT RATIO .0369 1.0 0 0 0 1.1555 4.2413 .0637 .2312 .1251 .0087 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) : -FIBROSIS, CAPSULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL THYMUS (TH) : -HEMORRHAGE, -MINIMAL -INVOLUTION,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT 420 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) 421 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: 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 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) .0689 2.1061 2.2832 8.6507 .1184 .5182 .2544 .0185 .0258 % .7894 % .8558 % 3.2424 % .0444 % .1942 % .0954 % .0069 % .0327 1.0000 1.0841 4.1074 .0562 .2460 .1208 .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 THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT UTERUS (UT) : >UNREMARKABLE 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) 423 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 .0 112 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 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) 425 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 1.0 0 0 0 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 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) 427 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: 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 1.0 0 0 0 1.0150 3.8406 .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 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, NQNGL (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), 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) 429 APPENDIX 6 Individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFQNAMIDO 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 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 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) , 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) 431  APPENDIX 6 Covance 6329-225 3M T-6314.1 Individual Anatomie Pathology Data 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 .0 121 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 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) 433  4 APPENDIX 6 Covance 6329-225 3M T-6314.1 Individual Anatomie Pathology Data 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 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) .0642 1.8999 2.3886 8.8486 .1396 .4933 .2034 .0280 .0205 % .6070 % .7631 % 2.8270 % .0446 % .1576 % .0650 % .0089 % .0338 1.0000 1.2572 4.6574 .0735 .2596 .1071 .0147 WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OB SERVAT ION S 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 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), 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) 435 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 % ------------------------- ------------------------------------------------- jjOT TAKEN JJOT TAKEN JJOT TAKEN WEIGHT TAKEN jjOT TAKEN jjOT TAKEN jjOT TAKEN jjqt 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) 436 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) 437 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) 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) ------------------- 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) 439 t 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: 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) 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: 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 7.1747 .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 O B SERVA T ION S 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 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-MEFOSE, T-6314) IN RATS PAGE: 154 nncv pKnnp 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE 12/02/98 S & Z S S ' S f DEATH: S T WEEK o T E E S f l! TERMINAL BODY WEIGHT: 268.9 GRAMS RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 12:35 POST-FIX WEIGHER: NOT AVAILABLE patoolOGIST^JOHN^IGHMY PATHOLOGIST. JOHN EIGHMY________________ WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR <FM >' . c m m r n i (STU p y o <EY) BRAIN (BR) T ' (l i ?RN^ D N E Y (KD) HEART (HT) , MUSCLE, SKELETAL (SM) URINARY BLADDER (B) ! UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA) , TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: . IWR) NERVE ADDUROEDNEAN:LUnMM m(DmU)L,LjJEEJJUUNNUUMM w e ?A i l e u m ^ TM IT^ ^ p^ ^ ) S,roLON' (Co) T rc t u m T r e V; lnV MANDIBULAR (MN), s m .i v S . `S i i x " S U S S . TM . > S . 0L S <" > URINARY BLADDER (UB) ,'UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGTM*_|Y*1. FB" LE 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 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: 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) 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0641 2.0289 1.8478 6.0936 .1647 .4325 .3476 .0341 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0267 % .8447 % .7693 % 2.5369 % .0686 % .1801 % .1447 % .0142 % ORGAN TO BRAIN WEIGHT RATIO .0316 1.0000 .9107 3.0034 .0812 .2132 .1713 .0168 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 THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT 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: 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) 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYRO ID/ PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0752 2.0931 2.4475 9.9107 .1232 .5403 .3750 .0228 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0210 % .5840 % .6829 % 2.7653 % .0344 % .1508 % .1046 % .0064 % ORGAN TO BRAIN WEIGHT RATIO .0359 1.0000 1.1693 4.7349 .0589 .2581 .1792 .0109 ORGAN S T A I ?U S 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 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: 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) APPENDIX 6 Individual Anatomic Pathology Data C ovance 6329-225 3M T - 6 3 1 4 . 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 449 a 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) 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: 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 1.0 0 0 0 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, PERI PORTAL,-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) 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0630 2.0244 1.9083 7.1598 .1099 .4890 .2793 .0179 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0276 % .8863 % .8355 % 3.1348 % .0481 % .2141 % .1223 % .0078 % ORGAN TO BRAIN WEIGHT RATIO .0311 1.0000 .9426 3.5368 .0543 .2416 .1380 .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 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) 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 % .1269 % .0089 % .0301 1.0 0 0 0 .8721 3.2920 .0575 .2774 .1390 .0098 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 UTERUS (UT) : -DILATATION,-MODERATE 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: 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) a p p e n d ix 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY^WITH^N-METHYL ^ Covance 6329-225 3M T-6314.1 PAGE: 167 ANIMAL NUMBER: <-9600 SoEdXa:. FEM-A-LoE1uuj- DOSE GROUSPT:UDY WE--EK OF DEATH: f - . SSTTUUDDY DAY 3 O F D E A T H p R " S E C T O R L _ T O D D t A C K E R WEIGHER^ 'LYNN ^HORNER_ G H "s DATE o f DEATM :n^2 MKCROPSY: 12/02/98 SS.SSm|-.. ORGAN NAME ADRENAL (AD) BRAIN (BR) k i d n e y (KD) liver (L I) OVARY (OV) SPLEEN ( S P ) THYMUS (TH) THYROID/PARATHYR (TT)^___ PATHOLOGIST : JOHN EIG_HMY_ -------------------------------------- n`o r g a n w e i g h t r e l a t i v e m unnY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO (GRAMS) .0265 .0516 1.9505 .0196 % .7399 % .8566 % 1.0 0 0 0 1.1576 4.2554 2.2579 8.3001 3.1487 % .0467 % .0631 .2566 .1230 .5005 .2900 .0143 .1899 % .1100 % .0054 % _________________ ------ " .1487 .0073 O B S E R V A T IONS histopathology nO RP G A N STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN necropsy "" 5 S S s TM -NO MACROSCOPIC LESIONS APPENDIX 6 individual Anatomic Pathology Data H OE l S XS o " TM - "' S . ! T PERFLUOROOCTANESULFONAMIDO ETHAN ___________ Covance 6329-225 3M t -6314.1 PAGE: 168 . ANIMAL NUMBER: C96004 DATE OF DEATH: 12/02/9B SSS-S S M ___ __-- -- ---- ^ "" "* SEX: FEMALE SE GRstUDY WEEK OF DEATH: 14* " TM s ` RECORDER: WENDY CHEKK " " STUDY DAY OF DEATH: 93 T0DD ACKER WEIGHER: LYNNHORNER______________ 12/O2/90 7 =34 PPARTOHSOELCOGTIUS_T: J,OH,N ErIGaHMY_ ____ ___ __ < * " s*.Wj- " "8" " s" DE THE f o l l o w i n g t i s s u e s w e r e LIVER (LI) ___ APPENDIX 6 individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 PAGE: 169 DATE OF DEATH: 12/02/98 WC* -- S,Q,, fi.ns PROSE"CTOaR:m "JERALD W. JOHNbUN DATE AND TIME OF NECROPSY: 12/02/98 . PATHOLOGIST: JOHN EIGHMY unQT-i'TX WEIGHER: NOT AVAILABLE _ ____________________________ ----------------------------------- ABSOLUTE"ORGAN WEIGHT " ORGAN NAME ADRENAL (AD) BRAIN (BR) k i d n e y (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 OBSERVATIONS TERMINAL SACRIFICE ' WEIGHER: LYNN HORNER *" ORGAN TO BRAIN WEIGHT RATIO .0370 1.0000 1.1714 4.3410 .0581 .2368 .1772 .0085 organ STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN HISTOPATHOLOGY necropsy LIVER (LI) : , LYMPHOHISTIOCYTIC,-MINIMAL -INFILTRATE -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS THE m _____ S K K S?cteTM C T ), =, s t e e h h k isb) e v e w v u " " " S I c Le . s k e l e t a l (Ml S : sKKAiSPm E "UTM " S i >" ' 'SiTM " " iE S " i) M. iOIELA < URINARY BLADDER (UB) , _________________________________________________ -------------- 457 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TO X I C I^ STUDY WITH N-METHYD TinDnrv'T&NESnLFONAMIDO ETHANOL (N-MEFOSE, 1 ^ PAGE: 170 DOSE GROUP: 2 ?M TM SS; 12/02/98 STUDY WEEK OF DEATH: i2 M j 0 F DEATH:PJRO3SECTOR: MICHELE ZIMA PATHOLOGIST: JOHN EIGHMY POST-FIX WEIGHER :^NOT^AVAI LABLE^ ' 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) .0512 1.9754 1.8567 7.3435 .1079 .4943 .2233 .0032 .0205 % .7927 % .7451 % 2.9468 % .0433 % .1984 % .0896 % .0013 % OB SERVATIONS NECROPSY "3 ' T E ^ N ^ O D Y ^ I G H T ^ ^ 4 ^ 2 GRAMS RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS .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 HISTOPATHOLOGY LI^ i n f i l t r a t e , l y m p h o h i s t i o c y t i c .-m i n i m a l GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS EOELOWItlG E S I S T E R . TM ISEI, 130TM. f EEMWM lfB) . JJE i m . BEAI SKELETSL |S> ------------------------ 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 .12 10 .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) 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: 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) 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 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) .0564 1.9241 1.8706 5.9471 .1006 .4206 .1966 .0090 .0270 % .9219 % .8963 % 2.8496 % .0482 % .2015 % .0942 % .0043 % .0293 1.0000 .9722 3.0908 .0523 .2186 .1022 .0047 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 461 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-63U.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 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 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) 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: 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 S T A I 'U S 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) 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: 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) 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) 465 Ri APPENDIX 6 Covance 6329-225 3M T-6314.1 Individual Anatomie Pathology Data 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 % ------------------------- ------------------- ------------------------------- jjOT 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) 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: 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) 467 4 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: 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 OF 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) 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: 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 469 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) 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) 471 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0805 1.9028 2.0616 8.0095 .1174 .5094 .2793 .0175 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0288 % .6803 % .7371 % 2.8636 % .0420 % .1821 % .0999 % .0063 % ORGAN TO BRAIN WEIGHT RATIO .0423 1.0000 1.0835 4.2093 .0617 .2677 .1468 .0092 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 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 (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) , TAIL (TI) 472 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL ____onM iiuTriri i.TM . TM iM .M irvnCK T - G 3 1 4 } PAGE: 185 " " V S E E ' 96019 SSS TM- " kSffPOST-FIX WEIGHER: SCHEDULED, TERMINAL SACRIFICE SsTsf"f"iS.rs?foffi':S_I S_f l_f _""3DEATHi d WEEK TERMINAL BODY WEIGHT: 283.2 GRAMS ' RECORDER: TERRI L. WILLIAMS WEIGHER: TONY HANFELD ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO u K <i A IN STATUS ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) 2.0462 .6 HH/ 8'?^4 ,Xq -J? " ' 8 .U2US .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 ----------------------- QBSERVATIONS HISTOPATHOLOGY NECROPSY UT-l u m e n B i l l e d w i t h f l u i d ; b i l a t e r a l : c l e a r f l u i d GENERAL COMMENT (GC) : -DILATATION, -SLIGHT ................. 473 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 ^ f o p " : 12/02/98 STUDYFD ^ LOF DEATH: S g g -S g & E R : NNOT0AvIl^E2/98 ^ ^"DY SCHEDULED, TERMINAL SACRIFICE WEEK O ^ T n f i f ^ TERMINAL BODY WEIGHT: 283.2 GRAMS ! RECORDER: TERRI L. WILLIAMS ______________ WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE U N R E M A R K A B L E ^ NECROPSY: STERNUM (SB), EYE (EY>, BRAIN (BR), BONE, FEMUR (FE) , M A R R O W . FEMUR (FM), , ^ R0" ` STERNUM (SE) , BONE, S T B TM 1 <KD> , HEART (HT) , MUSCLE. SKELETAL <SM) , SPINAL CORD (SC), LUNG (Ml) , , TM C H E A C T R ) . ESOPHAGUS (ES), LIVER (T*, PARATHYROID (PT) , S S ^ S S (M A N D l f ? S G ? f HARDERIAN^GLAND ^HG) .^AUDITORY S E B ^ G L ^ A S ) ! 'SKIN `SK>' URINARY BLADDER (UB). CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) _____________________ ^' 474 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY N -METHYL ,,^T,c.Tt,/-,t-u-in>i'aMi7GrTr,S'nNAMTDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 187 SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C96020 DATE OF DEATH: 12/02/98 It UDY^AY^OF DEATH- 9 3 ^ GRC>STUDY WEEK OF DEATH: 14 STUDY DAY OF DEATHpR" ECT0R: bJ0HN g. HALFORD TERMINAL BODY WEIGHT: 239.9 GRAMS RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 12.Ub PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) _______ _ ABSOLUTE ORGAN WEIGHT (GRAMS) .0746 1.9018 2.0893 8.3210 .1320 .4508 .2735 0172 ____ ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO .0311 % .7927 % .8709 % 3.4685 % .0550 % .1879 % ,1140 % .0072 % .0392 1.0000 1.0986 4.3753 .0694 .2370 .1438 .0090 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN OBSERVATIONS HISTOPATHOLOGY NECROPSY " ^ N F I L T rIt E , LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS TMe ek s s . e. . s r s '?! ' e *. >. - ( S T M . :RECTUM (RE), LN, MAN--DIBULAR (MN), MAMMARY.,..F.E.M.A.L.E..(.M.F.).,-- ... 475 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 .2 1 1 0 .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 OBSERVATIONS HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL 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: 189 ANIMAL NUMBER: C96021 DATE OF DEATH: 12/02/98 SEX: FEMALE STUDY DAY OF DEATH: DOSE 93 GROUP: 3 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 DATE AND TIME OF NECROPSY: 12/02/98 10:36 PROSECTOR: JERALD W. JOHNSON POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 239.7 GRAMS RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: ,on, m BRAIN (BR> S lTM IsC)', LUNG^^LU^^TRACHEA* (TR)^^ESo !hAGUS^ (ESK 'LIVER* (LI^^^KIDNEY (KDK^ HEART^HT)^ 14USCLE, SKELETAL (SM) NERVE SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS)f THYROID (TY) , PAJ^THYRXD {PT)# xSgSA<ii?!'cliSS^SST. . j r s a s i s s .'s f c r s r - THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 477 4 APPENDIX 6 Covance 6329-225 3H T-6314.1 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL DBBPT.iinnmCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) PAGE: 190 ANIMAL NUMBER: C96022 DATE OF DEATH: 12/02/98 SEX: FEMALE DOSE GROUP: 3 SACRIFICE1 S,TATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: GREGORY CODDINGTON DATE AND TIME OF ^ 0 ^ : ^ 1 2 / 0 2 / 9 8 12:09 PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 264.4 GRAMS RECORDER: TERRI L. WILLIAMS WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT 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 1.0 0 0 0 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 -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 478 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-W EEK D IETA R Y T O X IC IT Y STUDY W IT H N -M ETH Y L p p n F T .n n R O O C T A N E S U L F O N A M ID O E T H A N O L (N - M E F O S E , T-6314) PAGE: 191 ANIMAL NUMBER: C96022 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX- FEMALE STUDY DAY OF 12/02/98 12:09 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 3 SACRIFICE STATUS: DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: GREGORY CODDINGTON PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 264.4 GRAMS RECORDER: TERRI L. WILLIAMS WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW -STERNUM (SB) ' otprnitm (SB) EYE (EY) , BRAIN (BR) , '(K^ H E A W (HT), MUSCLE, SKELETAL (SM), NSEPRIVNEA,L CSOCRIDATI(CSC)(,SN)LU,NGSPL(ELUE)N ' (,SP) 1'J TM<0 < 7-tHh)^ .T NL^NM E^SEENNTTEERRIICC ^(MMSS)KL TTHHYYRROOID ^(TY) , ^PARA(TjHtY)R_OISDT0M(APCTH);, N0NGL (SU) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO) ' PTMJITAR COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), I L E m VLh) . CECVH j C E ) , COLON UJI ^MMARy FEMALE (MF), SALIV GL MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (Ab) , bRIM I W URInIrY BLADDER (B) ! UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION. STOMACH, GL (ST), STOMACH, NONGL (SU) 479 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL pwpvtjtorooCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE! 192 ANIMAL NUMBER: C96023 DATE OF DEATH: 12/02/98^ SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE SEX: FEMALE 12/STUDY D A Y O T DOSE DEATH : GROUSPT:UD3Y WEECKODODFINDGETAOTNH: 14 TERMINAL BODY WEIGHT: 253.0 GRAMS RECORDER: TERRI L. WILLIAMS DATE AND TIME OF NECROPSY: POST-FIX WEIGHER: NOT AVAILABLE ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) PATHOLOGIST: JOHN EIGHMY ABSOLUTE ORGAN WEIGHT (GRAMS) .0695 2.0599 2.5238 10.5886 .1184 .5279 .3996 .0150 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0275 % .8142 % .9975 % 4.1852 % .0468 % .2087 % .1579 % .0059 % WEIGHER: TONY HANFELD ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS .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 Ob s e r v a t i o n s HISTOPATHOLOGY PSY -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH!N-METHYL nnDnni'TMKSnTmNAHIDO ETHANOL (N-MEFOSE, T-6314) IN PAGE: 193 ,, J S , - de,,H! 55- ""Si5 -- ofSSSMTM"3' = l H = r i s l l ""s _____________ = ; , o -- ----------- ss,* 'a a - THE FOLLOWING T I S S U E S W ERE UNREM ARKABLE A T M IC R O S C O P IC E X A M IN A T IO N : STOMACH, G L ( S T ) , STO M A CH , N ONGL ( S U ) _ __________________________ 481 a p p e n d ix 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY TM "(-METHVL < l \ T V T3 71fT>C nnmm TYrmr^nrpa'KrpQnT.FnNAMIDO ETHANOL (N-MEFOSE " PAGE: 194 ^ = s , a.. i s / - - DEM,,, 55SSI ^ "g S 'o ^ JV, 12^08 22,22 P O S T -F IX W EIG H ER: NOT A VA ILA BLE -- ORGAN NAME ra in u ABSOLUTE ORGAN WEIGHT (GRAMS) 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 NECROPSY ofossfifTM 5- s f o . s i r ",, _ c i r 'D T f T n J STA TU S- SCHEDULED, TERM IN A L S A C R IF IC E S K , 't TM _____ ------------------------------------------------ ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO STATUS .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 BSERVATIONS HISTOPA TH OLOG Y L I -H YPERTROPH Y, HEPATOCELLULAR, CEN TR I LOBULAR, -M IN IM A L -IN F IL T R A T E , LY M PH O H ISTIO C Y TIC , -M IN IM A L GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS APPENDIX 6 Individual Anatomie Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITM N-METHYL TV rn c rmonrv'rnim'OT.FflNMIDO ETHANOL (N-MEFOSE, T-6314) C ovance 6329-225 3M T - 6 3 1 4 . 1 PAGE: 195 n r - "S^-SS"- -- "s`G"-- -DDAATTEE OAFNDDETAITMHE: OF12N/0E2C/R9O8PSY: 12/0..2/.9.8j 1122-.1122 PPRAOTSHEOCLTOOGRI:ST:JODJIOHNTHIEEIRGEHNMY ^WWEEIGIHGEHR-E RT.O^NYu mH^AmNF-E-L-D----------- POST-FIX WEIGHER: NOT AVAILABLE _ __________________________________________________ - THE~FOLLOWING ORGANS WERE^ONREMARKABLE^AT NECROPSY: BONE, FEMUR (FE) . m a r r o w , f e m u r ^ m ). SPINAL CORD (SC) , LUNG (LU) THYMUS (TH) , LN, NERVE, SCIATIC ADRENAL, CORTEX (SN), (AC), SAPDLREEENNAL(,SPJ)MEEJDUUNLULMA (MA) , AORTA (JE) , ILEUM MESENTERIC (MS), (AO) , PITUITARY (IL) , CECUM (CE) EYE (EY) , BRAIN (BR) , , HEART (HT), MUSCLE, SKELETAL PARATHYROID (PT) , / Tp Ht Y\ ROISDTOMACH GL (ST), STOMACH, NONGL (SU) , C O M N ^C^t? RECTUM (RE) , LN. MANDIBULAR <MN) SKIN (SK), MAMMARY, FEMALE (MF) , (SM), , -i inn.: AUDITORY S OVARY (OV) , VAGINA (VA) , TAIL (TI) URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: THE FOLLOWING 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: 196 ANIMAL NUMBER: C96025 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 DAT AND TIME OF NECROPSY: 12/02/98 11:33 PROSECTOR: KIMBERLY DURLAND POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 253.9 GRAMS RECORDER: TERRI L. WILLIAMS WEIGHER: TONY HANFELD ORGAN NAME (GRAMS) ORGAN W EIGHT R E L A T IV E TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATI ORGAN STATUS ADRENAL (AD) BRA IN (BR) K ID N EY (KD) LIV ER (L I) OVARY (OV) SPLEEN (S P) THYMUS (TH ) TH Y R O ID /PA R A TH Y R (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 W EIGHT TAKEN W EIGHT TAKEN W EIGHT TAKEN W EIGHT TAKEN W EIGHT TAKEN W EIGHT TAKEN W EIGHT TAKEN W EIGHT TAKEN NECROPSY OBSERVATIONS H IST O PA T H O L O G Y 'OMAOH GL ( S T ) * -L IG H T FOCUS ( I ) /A R E A (S ) ; MUCOSA, NEAR ESOPHAGEAL GROOVE: SIN G L E W H ITE P IN P O IN T SLIG H T LY R A ISE D FOCUS L N , M ANDIBULAR (MN) : -M OTTLED; B IL A T E R A L : RED AND TAN OVARY (OV) : -D IF F U S E L Y RED ; BILA TERA L GENERAL COMMENT (G C ) : -B O N E 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 L IM IT IN G R ID G E . L N , M ANDIBULAR (MN) : -H EM O R R H A G E ,-M IN IM A L OVARY (O V) : UNREMARKABLE 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: 197 ANIMAL NUMBER: C96025 , o i r o T U T i 'F STATUS- SCHEDULED, TERMINAL SACRIFICE STUDY^DAY^OF DEATH: " " ^ S T U D Y WEEK OF DEATH: 14 ' TERMINAL BODY WEIGHT: 253-^G = S S 'o ^ J s v . POST-FIX WEIGHER: NOT AVAILABLE S i ? ; S S S ," 3 1S " " ____________________________________________________ _________ THE HARDERIAN GLAND (HG), AUDITORY S E BbL CERVIX (CV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, NONGL (SU) _______________________________ (UT) , 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: 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0700 1.9824 2.0 111 8.3034 .1165 .4610 .2781 .0139 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0301 % .8526 % .8650 % 3.5714 % .0501 % .1983 % .1196 % .0060 % ORGAN TO BRAIN WEIGHT RATIO .0353 1.0000 1.0145 4.1886 .0588 .2325 .1403 .0070 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS H ISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS L IV ER ( L I ) : -H YPERTROPH Y, HEPATOCELLULAR, CEN TRILOBU LA R, -M IN IM A L -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 APPENDIX 6 I n d i v i d u a l 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 DATE OF DEATH: 12/02/98 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 3 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 DATE AND TIME OF NECROPSY: 12/02/98 11:08 POST-FIX WEIGHER: NOT AVAILABLE PROSECTOR: GREGORY CODDINGTON PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 232.5 GRAMS RECORDER: TERRI L. WILLIAMS WEIGHER: TONY HANFELD ss&THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, cT'VDMnM lent EYE (EY) BRAIN (BR) , ,i.cf *rt u e r ' (IT\ KIDNEY (KD) HEART (HT), MUSCLE, SKELETAL (SM) ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO) , PITUI COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA) , TAIL ( -- <" > THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 487 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 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 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 ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0659 1.9373 2.3111 9.8850 .1046 .5319 .3779 .0177 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0222 % .6527 % .7787 % 3.3305 % .0352 % .1792 % .1273 % .0060 % ORGAN TO BRAIN WEIGHT RATIO .0340 1.0000 1.1929 5.1025 .0540 .2746 .1951 .0091 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 -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL 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 wsTM ^ r y ss; Si/ L. sr* "sd? ,,issssfif" DS- s s s V vTERMINAL SACRIFICE 296.8 GRAMS RECORDER: TERRI L. WILLIAMS sss.fs s ShS,"ss;osli^2,m10,10 " ______ WEIGHER: TONY HANFELD THE FsOsLL,O,WIFNiGxORGAsNiS' s rWERE UaNREDM)A"R^KAiB5LESA'T(NSEC"RO*PSsYo:?sTM<E,iK'LTMcrip'p.MsTTrMs/osr \ FYE iEYl jScBRAIN (BR) i = . <>. NERVE SCIATIC (SN) , SPLEEN (SP), THYMUS (TH> , LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , EL?js!'D= ^ ,oiSvi?>(cvr= W/Sfet s r - THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) 489 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 awTM&T KrtTMRRR C96028 m i f o p " TM ; 12/02/98 SCHEDULED, TERMINAL SACRIFICE SEX: FEMALE STUDY DAY OF DEATH: DOSE 93 GROUP: 3 STUDY WEEK SACRIFICE STATUS: OF DEATH: 14 TERMINAL BODY RECORDER: WEIGHT: STEVE VAN 259.6 GRAMS ADESTINE DATE AND TIME OF NECROPSY: 12/02/98 9:00 POST-FIX WEIGHER: NOT AVAILABLE p TM TM OC^ST^JOHN EIGHMY^ 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) .0628 1.9952 2.0909 8.7646 .1106 .5702 .3955 .0193 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0242 % .7686 % .8054 % 3.3762 % .0426 % .2196 % .1523 % .0074 % ORGAN TO BRAIN WEIGHT RATIO .0315 1.0000 1.0480 4.3928 .0554 .2858 .1982 .0097 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL UPPER INCISORS 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 5 f 5f" 5 : 12/02/98 !?5dv'dS " f d e a t h , /fC "" s TM W TM " s s s . T O J s a * ' " 9' " sssa ^ k s^ ________ SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 259.6 GRAMS RECORDER: STEVE VAN ADESTINE WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY) , BRAIN (BR) , BONE FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) . BONE, : /, HEART (HT) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC) ! LUNG (LU) , TRACHEA (TR) ^ 0 TM A G U S (ES) LIVER LI) ^ N E Y ^ K D ) -^ R T ^ ^ ) .^ ( NERVE, SCIATIC (SN) , SPLEEN (SP) , TM Y M U S ^ n f ^ P T T U I T A R Y IH QL (ST) ; STOMACH, NONGL (SU) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA ( ) COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , 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: 204 ANIMAL NUMBER: C96029 DATE OF DEATH: 12/02/98 SEX: FEMALE STUDY DAY OF DEATH: DOSE 93 GROUP: 3 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 DATE AND TIME OF NECROPSY: 12/02/98 7:41 POST-FIX WEIGHER: NOT AVAILABLE PROSECTOR: NANCY DIEDRICH PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 239.5 GRAMS RECORDER: STEVE VAN ADESTINE 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 .2 b '4 b .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 LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRI LOBULAR, -MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH 1N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL {N-MEFOSE, T-6314) IN RATS PAGE: 205 STATUS * SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C96029 fSi/SS" DEATH: 5 f ""0? EEK "SIS" i"TM' DSATE OSF , D"ESATSH:,=1i2>/i 0S2/E98 . J . J , 5 ? 5 D= H S ' - __________ I S " TM " S / | teTM (. i TM w " S i . . SKELETAL (E.) . THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, __________________________________________________________________________ _ _ _________ 493 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: C 96030 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 DATE AND TIME OF NECROPSY: 12/02/98 11:22 PROSECTOR: JODI THIEREN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 243.6 GRAMS RECORDER: TERRI L. WILLIAMS 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) .0640 2.0259 2.1625 10.3610 .1272 .5984 .2458 .0121 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0263 % .8317 % .8877 % 4.2533 % .0522 % .2456 % .1009 % .0050 % ORGAN TO BRAIN WEIGHT RATIO .0316 1.0000 1.0674 5.1143 .0628 .2954 .1213 .0060 STATUS 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) : RIGHT LOBE: LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN MULTIPLE PINPOINT FOCI -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, COAGULATIVE,-MINIMAL THYMUS (TH) : -HEMORRHAGE, -MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL 494 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL TTrDnnr*TiaMTrcnT.pm'JAMTDn ETHANOL (N-MEFOSE, T-6314) PAGE: 207 SEX: FEMALE ANIMAL NUMBER: C96030 STUDY DAY OF DDPAAOTTSEET-OAFFNIDXDEWTAEITIMHGE:HEORF1:2/N0EN2CO/RT9O8PASVYAILA1B2L/E02/98 11:22 DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 243.6 GRAMS DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: TERRI L. WILLIAMS PROSECTOR: JODI THIEREN WEIGHER: TONY HANFELD PATHOLOGIST: JOHN EIGHMY_ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY. STERNUM (SB), EYE (EY), BRAIN (BR) , ,CM> BONE, FEMUR (FE) , MARROW, FEMUR(FM), (ESI 'l IVEr '(LI) , KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), LUNG (LU), TRACHEA <TR), ROID (TY>, PARATHYROID (PT) , ADRENAL, CORTEX (AC) , NERVE, SCIATIC (SN) , SPLEEN (SP), LN,MES^TERIC (MS) .THYROID l ^ ST0MACHf JJONGL (SU) , PANCREAS (PA) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY ( ), (>? (CO), RECTUM (RE), SALIV GL, MANDIB (SG) n , URINARY BLADDER ,U> . UTERUS 1UT) . CERVIX (CV) , OVARY (OV) , VAGINA (VA) , TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) __________________ 495 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 DATE OF DEATH: 10/01/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 10/01/98 11:34 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 3 SACRIFICE STATUS: DEATH: 31 STUDY WEEK OF DEATH: 5 PROSECTOR: WENDY CHERRY PATHOLOGIST: JOHN EIGHMY SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 205.5 GRAMS RECORDER: KEVIN BILLINGS 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 NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN THE FOLLOWING ORGANS n n m ? F F M I1R I FEV SPINAL CORD SC) WEMRAERROUNWREFMAERMKUARBL(EFM)AT, NMEARCRROOWP,SY:STERNUM (SE) , BONE, oStTpEfRhNmUmM /(SqBm), fEvYfE ((FEYY)) , BBRRAAIINN LUNG (Lu( TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD) , HEART (HT) (BR) MM(UUBSSRCC)LL, ]E, SKELETAL (SM), NERVE SCIATIC (SN) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), THYROID (TY) , HnMPT /en \ ADRENAL CORTEX (AC) ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, ^ONGL PANCREAS (PA) DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE) ' MANDIBULAR (MN) , qftLTV GL MANDIB (SG) HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SKIN (SK) , MAMMARY, FEMALE (MF)> S inL J E S S (1?,'u t e r u s ^luT), CERvix (CV) , OVARY (OV) , VAGINA (VA) , TAIL <TI),J E N E ^ L COMMENT_ (GC)___________________ 496 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITHN-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T 6314) IN RATS PAGE: 209 STMSr" ; S5STM ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR KioP TMH,R3iECT(mi ,, CHE>RDOSE GROUP: 3 SACRIFICE STATUS : SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 203.4 GRAMS STUDY WEEK OF DEATH: 5 RECORDER: KEVIN BILLINGS ' J M H O ^ I S T , J O _ K G H K ________ WEIGHER: MICHELE ZIMA ABSOLUTE ORGAN WEIGHT (GRAMS')' ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN NOT TAKEN NOT TAKEN 6.7736 3.3302 % WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN (TT) THE FOLLOWING ORGANS W'E^RAERRUONWRREEMFAERMKUARBBIL(EFM^tA'!T' NECROPSYS^ T O ^ (SE) BOTE STERNTO^SB) ,^ Y E U2YK BRAIN BONE, FEMUR SPINAL CORD (FE) , (SC), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES), LIVER ( > . 1U ' PARATHYROID (PT) , NERVE, ADRENAL, SKELETAL (SM) __ TAIL (TI), 497 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL DUDvT.nnnnnTTANESIJLFONAMIDO ETHANOL (N-MEFOSE, T-6314) PAGE: 210 SCHEDULED, FIRST INTERIM SACRIFICE ANIMAL NUMBER; C.6033 DE,, ,, . f B " S . J ,,EEK TERMINAL BODY WEIGHT: 210.3 GRAMS RECORDER: KEVIN BILLINGS WEIGHER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE ^ _ ___ ----------------------------------- m s o l o t e 'o r g ^n 'w e i g h t ORGAN NAME (GRAMS) ___________________________ organ weight relative TO BODY WEIGHT (%) m e i g Htr a t i o N WEIGHT RATIO ORGAN STATUS NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SKELETAL (SM) NERVE, SCIATIC (SN) , (AO) PITUITARY (PI) , STOMACH, GL (ST), STOMACH, NONGL (SU), ADRENAL, CORTEX (AC), ADRENAL ME D E L A (MA) , AORTA (AO) , PITUHAK t ^ RECTUM (RE), LN, MANDIBULAR (MN) , GENERAL COMMENT (GC) 498 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Covance 6329-225 3M T-6314.1 PAGE: 211 SI 10,oi% 2 ,, ! f POST-FIX WEIGHER: NOT AVAILABLE P * 5 E C T O ,, MATTHEW X T PATHOLOGIST: JOHN EIGHMY 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) 8.8195 3.7690 5 S S "' S 5 /TM _______________________________________ ORGAN TO BRAIN WEIGHT RATIO 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: ,, ,B V , r r ATN (BR) BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB) , EYE (EY), BRAIN (BR), qpINAL 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 M rTr*T /cm ADRENAL^"cORTEX ^AC i."a D R ^ ^ D U L L A .<m A) ,'AORTA .(AO) .,,PITUITARY IJI) J TM C H , ^ S T ) , C , PANCREAS (PA), DUODNUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM(CE) ' <CO ). RECTUM OAT TV pi MANDIB (SG) HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF), U M n r y BlS (OT?!'u K ( O T ) ; CERvix (V). OVARY (OV) , VAGINA (VA), TAIL (TI), ^NERAL_COMMENT_ (GC)__________ 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: 212 10/01/98 E SSSK . DAt I AND TIME OF NECROPSY: 10/01/98 11:21 POST-FIX WEIGHER: NOT AVAILABLE SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE DEATH: S?" WEEK OF DEATH: 5 PROSECTOR: WENDY CHERRY PATHOLOGIST: JOHN EIGHMY_____ TERMINAL BODY WEIGHT: 218.8 GRAMS RECORDER: KEVIN BILLINGS WEIGHER: MICHELE ZIMA ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) 7.2747 3.3248 % ORGAN TO BRAIN WEIGHT RATIO 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) , * *f BONE, STERNUM (SB), EYE (EY) BRAIN (BR), (" J'Li v ER ( 7 7 * 1 1 ? ' (KD) 7 HEART (HT) , MUSCLE, SKELETAL (SM) , ___________ ___ __ __ /m v ) n U D A fflU V O A T n iO H 'i S ^ k'JEJUNUM (JE), ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE) LN MANDIBULAR (UN). ^ r __________ 500 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: 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 1 CO 1 1 1-3 1 1> 1 1 u3 ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN 'U S 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 1.0 0 0 0 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 501 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: 12/02/98 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 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) 502 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: 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 (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS 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 % .0432 1.0 0 0 0 1.2777 4.7812 .0493 .2906 .1501 .0105 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 503 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) 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: 217 ANIMAL NUMBER: C96038 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 DATE AND TIME OF NECROPSY: 12/02/98 10:14 POST-FIX WEIGHER: NOT AVAILABLE PROSECTOR: JERALD W. JOHNSON PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 275.3 GRAMS RECORDER: WENDY CHERRY 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 OBSERVATIONS 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 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: 218 ANIMAL NUMBER: C96038 SEX: FEMALE DATE OF DEATH: 12/02/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 12/02/98 10:14 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 3 SACRIFICE STATUS: DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: JERALD W. JOHNSON PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 275.3 RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER GRAMS THE BONEOWFEMURR (^> ^ R r E= B^ r S o w ! Y STERNUM (SE), BONE. STERNUM (SB), EYE (EY) . BRAIN (BR, . S lS (SC): LUNG^^LU^fT r a c h e a (" " o p h a g u s (s )! l i v e r (l i ). k i d n e y (k d ), h e a r t (h t ). m u s c l e , s k e l e t a l (s m ) , NFRVF SCIATIC (SN) SPLEEN (SP) THYMUS (TH) , LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT) , AnFFN^L CORTEX (AC) ADRENAL MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH. GL (ST), STOMACH, NONGL (SU) , S Z s ^ A l DUODEi u M ^ D u t ,'JEJU N U M JE>, ILEUM (L) ! 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) 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: 219 ANIMAL NUMBER: C96039 SEX: FEMALE DATE OF DEATH: 12/02/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 12/02/98 8:13 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 3 SACRIFICE STATUS: DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: NANCY DIEDRICH PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 257.5 GRAMS RECORDER: STEVE VAN ADESTINE 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) .0835 2.0098 2.2091 9.1522 .1115 .4315 .3296 .0199 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0324 % .7805 % .8579 % 3.5543 % .0433 % .1676 % .1280 % .0077 % ORGAN TO BRAIN WEIGHT RATIO .0415 1.0 0 0 0 1.0992 4.5538 .0555 .2147 .1640 .0099 STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 507 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 DATE OF DEATH: 12/02/98 STUDY DAY OF DATE AND TIME OF NECROPSY: 12/02/98 8:13 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 3 SACRIFICE STATUS: DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: NANCY DIEDRICH PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 257.5 GRAMS RECORDER: STEVE VAN ADESTINE WEIGHER: TONY HANFELD THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY. cvp tvv\ BRAIN (BR) (SC)' l u n g ^Tlu^T^t r a c h e a ' (t r ^ ^ e s o p h a g u s ^ (e s k 'l i v e r '(l i ^ ^ k i d n e y (KDyE h e a r t ^(h t ) SKELETAL (SMK 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 Anatomic Pathology Data Individual Covance 6329-225 3M T-6314.1 PAGE: 221 SACRIFICE1STATUS: ^ ? N A l" TERMINAL BODY ^ 1 G H SACRIFICE T ^ w ^222l .I2AMgSr a m s TH SSETXU:DYFEDMAAYLEOF DDEEAATiHn: "93SeBct"or."TCK-ItxMmBrSEFRRtL?Y ThMYD U R L A N L i ' 11 _________S___S___f_--/ - ORGAN d a t e OF DEATH: 123//0^2/9-8,sY: 12//o0;2/98 12:04 PATHOLOGIST_________________ ---- d a t e a n d t i o f n e c r avaILABLE 'o Rg'an'w g HT ATI POST "FIX WEIGHERL_NOl_r _::__ -;b ^ u t e 'gORGAN w e i g h t JTo"b ODY~WEIGHT '(%) 0RGAN TO BRAIN WEIGHT^RATIO .0336 STATU S WEIGHT t a k e n w e i g h t TAKEN .0292 % 1.0000 WEIGHT t a k e n ORGAN NAME ADRENAL (AD) BRAIN (HR) KIDNEY (k d ) LIVER (LI) .0650 1.9359 2.3025 9.2333 .1810 .5292 .8693 % 1.0339 % 4.1461 % .0813 % .2326 % .1242 % 1.1894 4.2695 .0935 .2234 .1435 .0131 weight taken WEIGHT TAKEN WEIGHT t a k e n WEIGHT TAKEN WEIGHT t a k e n OVARY (OV) .2228 .0114 % SPLEEN (SP T'H^YYMRU0Sd /P(TAH^)THY_R__ITT)_____ .0253 0B SER V AT I ON S _________________________ NECROPSY 'GE! S S owT s m ^a r t a k e n 'm a c r o s c o p i c l e s i o n s _ _ -NO fAO APPENDIX 6 individual Anatomie Pathology Data Covance 6329-225 3M T-6314.1 ANIMAL NUMBER: C9604 13-WEEK DIETARY TM X ^ qlTTM-MEFOSEN T-6314) IIIN RATS PERFLUOROOCTANESULFONAMIDO ETHANOL (N MEtU PAGE: 222 , SACRIFICE STATUS : SCHEDULED, TERi E ^ Tf'^ 1 1 1 1 GRAMS q p y , female " SE GR0USTDY WEEK___o_f d e a t h : 14 STUDY DAY OF DEATH: 93 a^ ^ ERLY DORLAND " g&SE S WILLIAMS WEIGHER : TONY HANFELD____________ THE BONE, FEMUR SPINAL CORD NERVE, SCIATIC (eT'/CECUM (CE), COLON % { 55.SALIV GL, ^ , ^ > ' u^ r S ) ? L^ H v r ' ( v r 3 v ^ Y (OV), VAGINA URINARY BLADDER (UB), micr0SCOPIC EXAMINATION: THE EjYgR^LI) STOMACH^^UL^(StT^^STOMACH, NONGL (SU) EYE iSfli -- Le (MP) , - SKELETAL (SM) , 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: 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 HISTOPATHOLOGY GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT 511 m 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:i: 93 oSiTuUjDjiY WEEK uOrF jDEATH: 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) 512 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 GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL KIDNEY (KD) : -INFLAMMATION, CHRONIC,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL STOMACH, GL (ST) : -EROSION,-MINIMAL 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: 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) 514 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 .1 1 2 0 .4212 .2302 .0191 .0345 % .9235 % .9944 % 4.1887 % .0513 % .1929 % .1055 % .0087 % .0374 1.0 0 0 0 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); MUCOSA: MULTIPLE DARK BROWN AREAS, UP TO 4 X 2 MM GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT STOMACH, GL (ST) : -EROSION,-MINIMAL 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: 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, 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), 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, 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) 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 .120 1 .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 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: 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) 518 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 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: 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) 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: 233 AWTMftT 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 DAtI AOT> TIME'OF2 NECROPSY: 12/02^98 10:42 PROSECTOR: NANCY DIEDRICH ^CORDER^T^RIL^WILLIAMS POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER^ TOOT^HANFEL____________________ ORGAN NAME ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0612 2.0991 2.2050 11.8714 .1311 .5352 .3266 .0186 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0229 % .7865 % .8262 % 4.4479 % .0491 % .2005 % .1224 % .0070 % ORGAN TO BRAIN WEIGHT RATIO .0292 1.0 0 0 0 1.0505 5.6555 .0625 .2550 .1556 .0089 ORGAN STATUS WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NECROPSY OBSERVATIONS HISTOPATHOLOGY VER (LI) : ___ -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 521 APPENDIX 6 Individual Anatomic Pathology Data Covance 6329-225 3M T-6314.1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESUIiFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 234 ,,,, nnau pcnnp i SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C96046 ns nPATH- q?S G STUDY WEEK OF DEATH! 14 TERMINAL BODY WEIGHT: 266.9 GRAMS DATE OF DEATH: 12/02/98 STUDY DAY OF DEATHic" _ _ . TM nTEDRICH RECORDER: TERRI L. WILLIAMS DATE AND TIME OF NECROPSY: 12/02/98 10:42 p&Sum O G I S T ^ o L EIGHMY WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE _ _ PATHOLOGIST^ J________________________________________________________________ s s s sarrs^a-K?Mv? s s*isr5Ma: -- ... S S L ? IiS S I M i 'o S f l i S ) , CERVIX (CV). OVARX (OV) . VRG..IR TO). T,.,L 1TI) Sg?TiSeUmaNI^Sli.- ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO) , PITUI (SM) , SSSTSoS: ohoe W ) . COLON (CO) RECTUM (RE), LN, MANDIBULAR (MN! UsRI^NARLY BLADDER <UB) ! UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA)________"_________U___h__E___m__)_>______________ 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: 235 ANIMAL NUMBER: C96047 DATE OF DEATH: 12/02/98 SEX: FEMALE STUDY DAY OF DEATH: DOSE 93 GROUP: 4 STUDY WEEK SACRIFICE STATUS: OF DEATH: 14 DATE AND TIME OF NECROPSY: 12/02/98 11:53 POST-FIX WEIGHER: NOT AVAILABLE PROSECTOR: NANCY DIEDRICH PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 213.3 GRAMS RECORDER: TERRI L. WILLIAMS WEIGHER: TONY HANFELD ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT 1 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 OBSERVATIONS HI STOPATHOLOGY LIVER (LI) : -DIFFUSELY DARK; ALL LOBES: DARK BROWN UTERUS (UT) : -LUMEN FILLED WITH FLUID; GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN BILATERAL: CLEAR FLUID -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL ^--HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT UTERUS (UT) : -DILATATION,-SLIGHT 523 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: 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) , 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), 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) 524 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: DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY 12/02/98 DAY OF 10:40 DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: KIMBERLY DURLAND 14 POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 223.8 GRAMS RECORDER: TERRI L. WILLIAMS WEIGHER: TONY HANFELD ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT 1 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 % .9416 % 1.0293 % 6.2393 % .0777 % .2276 % .1328 % .0113 % .0404 1.0 0 0 0 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 525 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 (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) , 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) 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: 239 ^ r 0FN= !. 12/02/98 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 191.4 GRAMS f ^ D Y ^ F DEATH: S f " ^ S T U D ^ WEEK OF DEATH: 14 RECORDER: TERRI L. WILLIAMS DA?I AND^TIME'OF NECROPSY: 12/02/98 10:55 POST-FIX WEIGHER: NOT AVAILABLE "" ^ ^ S T ^ J O ^ E I G H M Y 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 Ob s e r v a t i o n s 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 -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL STOMACH, GL (ST) : -EROSION,-SLIGHT 527 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: 240 ANIMAL NUMBER: C96049 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 12/02/98 10:55 PROSECTOR: GREGORY CODDINGTON SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 191.4 GRAMS RECORDER: TERRI L. WILLIAMS WEIGHER :'TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE _ PATHOLOGIST:^JOHN^EIGHOT___________________" ,, ,, ,, l ______________ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: #r.\ t w o /o v \ nuarM {g}' LtMG^LU^E^TRACHEA#(TR^^ESOPHAGUS^ (ES^*LIVER* (LI^, KIDNEY (KD) , HEART (HT) .JoSCLE. SKELETAL (SM) , URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA), TAIL (TI) iieeTMsk-sjsk ia iissssep Msruffws sw" - -ssi-.-. URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA)______________________________________________ 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: 241 ANIMAL NUMBER: C96050 DATE OF DEATH: 12/02/98 ,,,,,, . c a r - m - F T C F . STATUS SCHEDULED, TERMINAL SACRIFICE SEX: FEMALE DOSE GROUP. 4 DEATH- 14 TERMINAL BODY WEIGHT: 216.8 GRAMS STUDY DAY OF DEATH;r" t STUDY WEEK OF DEATH. RECORDER: TERRI L. WILLIAMS DATE AND TIME OF NECROPSY: 12/02/98 11:40 PROSECTOR. GREGOTY CODDINGTON WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: ___________________________________________________ ORGAN NAME ABSOLUTE ORGAN W EIGHT (GRAMS) ORGAN W EIGHT R E L A T IV E TO BODY WEIGHT 1 ORGAN TO BRA IN W EIGHT R A TIO 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 1.0 0 0 0 .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 H ISTOPATHOLOGY GENERAL COMMENT (G C ) : -B O N E MARROW SMEAR TAKEN -N O M ACROSCOPIC L E SIO N S -H Y PER T R O PH Y , H EPA TO CELLU LA R, C EN TR IL O B U LA R ,-M O D ER A TE -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 HEPATOCYTE, -M IN IM A L -P IG M E N T , H EPA T O C E LLU LA R ,-M IN IM A L 529 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: 242 ANIMAL NUMBER: C96050 SEX: FEMALE SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE SE GS ! L J wpEK o f "d EATH~~14~ TERMINAL BODY WEIGHT: 216.8 GRAMS a ,'s s `=i,is a . U/SSmilPOST-FIX WEIGHER: NOT AVAILABLE "" i s H E r PATHOLOGIST^ JOHN^EIGHMY______ "WEIGHER: TTONBY8RHIANiF-ELWDIt"",s MUSCLE. SKELETAL , 3 . sssf s a f f u r - i a - . f M s ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO) , PITUTARY .l > s 1 0 ) RECTUM (RE), LN, MANDIBULAR (MN) , IH s i r r Du s j l^ i . i S ' E ? i ? lS ! ' s S ; r ; s i ? ,K s s S v . u l e <>. ' S ) , " e ; b l " " b h i I ! ' u S l I U T ), CERVIX l e w . OVARY (O V ), VAGINA (V A). TAIL R I > TMe s r s r i s ? 8 i s r s ^ 'i " s ^ ' S l S s .-,,. n e r v e ? s 2 ? A T f U N ) TM S P L E E N (SP), TM sJ t H) LN (M^sSoS NONGL (SU), ' o S m > ! ' i S <) !'cECUM (CE) . COLON (CO) , RECTUM (RE, ,^ M A N D I B U L A R (MN, . SPAANLCIRVEAGLS. (MPAA)ND,IB^SG??*1H A R D E R I ^ JG L M D HG ^ A U D I T O R Y 1S E B ^ G L ^ s H 'SKIN* (SK) ] MAMMARY, FEMALE (MF,. URINARY1*BLADDER" (b T! 'U R U H ); " c 5 v i F (V) 7 V A R Y (OV) . VAGINA(VA) 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: 243 59o 5o ? ) 9 8 f f u D Y ^ O F DEATH: SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 181.0 GRAMS RECORDER: KEVIN BILLINGS " SI ^ D TIMe 'o F NECROPSY: 10/01/98 11:19 POST-FIX WEIGHER: NOT AVAILABLE " ^ I S T ^ Z e IGh T 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 NOT TAKEN ADRENAL (AD) NOT TAKEN BRAIN (BR) KIDNEY (KD) LIVER (LI) 8.8661 4.8984 % NOT TAKEN WEIGHT TAKEN NOT TAKEN OVARY (OV) SPLEEN (SP) THYMUS (TH) NOT TAKEN NOT TAKEN NOT TAKEN THYROID/PARATHYR (TT) THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY) , BRAIN (BR) , BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BU , irrnwpv /Knl HEART (HT) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC) , LUNG (LU) , TRACHEA (TR) ESOPHAGUS (ES) LIVER LI) yTM | T <" '(,,) , NERVE, SCIATIC (SN) , SPLEEN ( SP) , THYMUS (TH) , LN, MESENTER ( ). IHY ST0 ^ACg_ GL (ST), STOMACH, NONGL (SU), AaDnRuEEHNAATL.,. CCOORRTTEEXX ((AACC)),. AADDRREENNAALL,, MMEEDDUUiLiLAA .(MA) , AORTA `(fAVO') ',^PIT^UI^_E_) ''c_O)LOn " (CoTT RECTUM~~(iRdEe)i , Lt.Nn, MMiANDIBULAR (MN) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ^ E U M U L ) ' ,ig) 'SKIN (SK), MAMMARY, FEMALE (MF) , ______________ 531 A PPEN D IX 6 I n d iv id u a l A n a to m ic P a th o lo g y D a ta C o vance 632 9 -2 2 5 3M T - 6 3 1 4 . 1 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 244 ANIMAL NUMBER: C96052 DATE OF DEATH: 10/01/98 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE SEX: FEMALE DOSE GROUP: 4 5 TERMINAL BODY WEIGHT: 202.7 GRAMS STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: RECORDER: KEVIN BILLINGS DATE AND TIME OF NECROPSY: 10/01/9S 11:52 POST-FIX WEIGHER: NOT AVAILABLE p^ hO L ^ I S t' ^ J O ^ E I G H M Y PATHOLOGIST. JOHN b i g h h i ______ WEIGHER: MICHELE ZIMA ORGAN NAME ABSOLUTE ORGAN WEIGHT (GRAMS) ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) ORGAN TO BRAIN WEIGHT RATIO ORGAN STATUS NOT TAKEN 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 WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 'ADRENAL, CORTEX (AC). ADRENAL, ^ D U L L A (MA), a u k TM PANCREAS (PA), DUODENUM DU) , JEJUNUM (JE) . ILEUM(IL) ^ CECUM ^CE , s i * " S '. SKELETAL (SM) , NONGL (SU), (cSTrilECTUli" ( M ) 7 l N. MiuTOIBULAR (MN). , MAMMARY. FEMALE (MF) -------- 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: C96053 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) 533 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) 534 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: 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 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) ------------------- 7.8851 ------------------------- ------------------- 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) 535 im APPENDIX 6 Covance 6329-225 3M T-6314.1 Individual Anatomie Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS PAGE: 248 ANTMM NT7MRFR- 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-F7IX 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) .0720 1.9559 1.9486 12.3563 .1065 .4034 .2087 .0187 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0344 % .9345 % .9310 % 5.9036 % .0509 % .1927 % .0997 % .0089 % ORGAN TO BRAIN WEIGHT RATIO .0368 1.0000 .9963 6.3175 .0545 .2062 .1067 .0096 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,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,- MINIMAL THYMUS (TH) : -HEMORRHAGE, -MINIMAL UTERUS (UT) : -DILATATION, -SLIGHT 536 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) 537 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: 250 HTiMmjjj. ^ ^ O F DEATH': 12/02/98 DATE AND TIME OF NECROPSY: SEX: FEMALE STUDY DAY OF DEATH: DOSE 93 GROUP: 4 STUDY WEEK SACRIFICE STATUS: OF DEATH 14 12/02/98 8:39 PROSECTOR: GREGORY CODDINGTON SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 250.5 GRAMS RECORDER: STEVE VAN ADESTINE WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY_____ 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 -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 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 (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) , 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) , CERVIX (CV) , OVARY (OV) , VAGINA (VA) 539 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: 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 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) 541 m 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: 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) LIVER (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 542 r. 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: 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) 543 fi APPENDIX 6 Covance 6329-225 3M T-6314.1 Individual Anatomie Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL 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 ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR (TT) ABSOLUTE ORGAN WEIGHT (GRAMS) .0718 2.0579 2.5943 13.5240 .1100 .4646 .3518 .0313 ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%) .0288 % .8245 % 1.0394 % 5.4183 % .0441 % .1861 % .1409 % .0125 % ORGAN TO BRAIN WEIGHT RATIO .0349 1.0000 1.2607 6.5717 .0535 .2258 .1710 .0152 ORGAN STATUS 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 544 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: 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) 545 APPENDIX 7 Cell Proliferation Report Covance 6329-225 3MT-6314.1 Note: This appendix o f the report contains information supplied by Pathology Associates International and has been reviewed by the Quality Assurance Unit of Pathology Associates International 546 Covance 6329-225 3M T-6314.1 Pathology Associates International A Company of Science Applications International Corporation FINAL CELL PROLIFERATION REPORT 13-W EEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T-6314) IN RATS COVANCE STUDY NUMBER 6329-225 PREPARED FOR: 3M TOXICOLOGY SERVICES BUILDING 220-2E-02,3M CENTER ST. PAUL, MN 55144-1000 PREPARED BY: PATHOLOGY ASSOCIATES INTERNATIONAL 15 WORMAN'S MILL COURT, SUITE I FREDERICK, MD 21701 MAY 12,2000 5 Worman's Mill Court, Suite I * Frederick, Maryland 21701 * (301) 663-1644 * (301) 663-8994 FAX 547 Covance 6329-225 3M T-63I4.1 Final Cell Proliferation Report Covance Study Number 6329-225 Page 2 TABLE OF CONTENTS I. CELL PROLIFERATION REPORT II. TABLES III. SIGNATURE PAGE IV. QUALITY ASSURANCE STATEMENT V. APPENDIX I 548 Covance 6329-225 3M T-6314.1 Final Cell Proliferation Report Covance Study Number 6329-225 Page 3 CELL PROLIFERATION REPORT 13-W EEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T-6314) IN RATS COVANCE STUDY NUMBER 6329-225 PURPOSE The puipose o f the study was to assess the toxicity o f the test material when adm inistered in the diet to rats for at least 13 weeks. This report, submitted by Pathology Associates International (PAI) to the study Sponsor, 3M, represents the cell proliferation findings and interpretation for Covance Study N um ber 6329-225 entitled " 13-Week Dietary Toxicity Study with N-M ethyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) In R ats" . All aspects o f the tasks associated with PA I's portion o f this study were conducted in compliance with the Food and Drug Administration Good Laboratory Practice (GLP) R egulations as set forth in Title 21 o f the US Code o f Federal R egulations, Part 58, issued December 22, 1978 (effective June 20, 1979), and with any applicable amendm ents. MATERIALS AND METHODS Tissue Collection for Cell Proliferation Five animals per sex per group in groups 1 through 4 were sacrificed during w eek 13 for hepatocellular proliferation. A section of the left lateral lobe o f the liver from each o f 5 rats per group (groups 1-4) was fixed and processed to paraffin block by Covance per protocol specifications. Tissue blocks were shipped to PAI for sectioning and staining. From each block, a slide was prepared for H&E evaluation and immunohistochemical detection o f proliferating cell nuclear antigen (PCNA), a marker o f cell proliferation. Immunohistochemistry for Cell Proliferation Sections o f paraffin-embedded tissues were cut at 5 pm and placed on positively charged slides (Superfrost Plus, Fisher Scientific, Pittsburgh, PA) to ensure adhesion during processing for PCNA. Standard immunohistochemical methods w ere used to stain tissues for PCN A (PA I's SOP for immunohistochemistry). Briefly, tissue sections were incubated with a monoclonal antibody to PCNA (DAKO, lot #016, PAI No. A1723) and reagents required for the avidin-biotin peroxidase (ABC Kit, lot #PK-6100, PAI No. K 324) method for the detection of the antigenantibody complex. PCNA expression in cells in all phases o f the cell cycle (G,, S, G2 and M) was localized by the chromagen 3,3'-diaminobenzidine (DAB; Sigma Chemical Co., lot #18H8201). Tissue sections were counterstained w ith hematoxylin. A negative control slide was included in the staining run and consisted o f study tissue that was not incubated with the primary antibody. 549 Covance 6329-225 3M T-6314.1 Final Cell Proliferation Report Covance Study Number 6329-225 Page 4 Cell Proliferation Measurements For cell proliferation evaluations, slides were first perused at low magnification (100X) to judge quality o f staining, processing and sectioning, pattern o f cell labeling (e.g., centrilobular or panlobular, extrahepatocellular proliferation, such as KupfFer cells, bile duct epithelium, endothelium), and histomorphologic changes. Cell proliferation was then quantified at higher magnification (200X). The percentage o f hepatocytes in S phase o f the cell cycle (labeling index, LI) was determined by scoring at least 3000 hepatocytes in 10 randomly selected fields per animal. Histomorphology was further assessed by evaluating the serial H&E slide for each animal evaluated for cell proliferation. Statistical Analysis The Student's f-test (two-sided, unequal variance) was used to test for statistical significance in LI between control and treatment groups using Microsoft Excel version 5.0. A P value o f less than 0.05 was judged to be statistically significant. RESULTS Cell Proliferation Individual animal and group mean cell proliferation data are presented in Section II (Table 1). The percentage o f proliferating hepatocytes, as determined by the labeling index (LI), was not significantly increased in treated groups compared to that o f controls in either male or female rats. The LI was significantly less than controls in female rats from groups 3 and 4. Histopathology Sections from the same tissue blocks used for preparation o f PCNA-stained slides were stained with hematoxylin and eosin (H&E) for histopathologic evaluation to facilitate the interpretation o f the immunostained slides. Individual animal findings and group summaries are presented in Appendix I. The results showed no changes in the liver tissue o f male and female rats that would alter the interpretation o f the PCNA staining in this study. 550 SUMMARY Covance 6329-225 3M T-6314.1 Final Cell Proliferation Report Covance Study Number 6329-225 Page 5 In the present study, cell proliferation was measured within the liver o f male and female rats from control (0 ppm), low dose (3 ppm), mid dose (30 ppm) and high dose (100 ppm ) after 13 weeks on study. No statistically significant increases in cell proliferation, as determined by the PCNA labeling index (LI) were observed in male or female rats after 13 weeks o f N -m ethyl perfluorooctanesulfonamido ethanol. Although cell proliferation was statistically less than controls in mid dose (30 ppm) and high dose (100 ppm) females, the decrease was not doserelated, and the individual animal values were within the range observed in control animals. Therefore, this decrease w as not considered to be biologically relevant. 551 Covance 6329-225 3M T-6314.1 Final Cell Proliferation Report Covance Study Number 6329-225 Page 6 n . TABLES Legend SEM = Standard Error of the Mean 552 Table 11-1. Cell Proliferation in Rat Liver Covance 6329-225 3M T-6314.1 Covance Study No. 6329-225 Dose Group 1 (Control - 0 ppm) 1 (Control - 0 ppm) 1 (Control - 0 ppm) 1 (Control - 0 ppm) 1 (Control - 0 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 4 (High -1 0 0 ppm) 4 (High -1 0 0 ppm) 4 (High - 100 ppm) 4 (High -1 0 0 ppm) 4 (High -1 0 0 ppm) j PCNA Animal Labeling Sex Number Index (%) M C95902 i 0.387 M C95905 0.246 M C95906 0.227 M C95909 0.153 M C95918 0.583 Mean 0.319 SEM 0.076 M C95924 0.190 M C95925 0.208 M C95927 0.235 M C95936 0.063 M C95937 0.224 Mean 0.184 SEM 0.031 M C95942 0.162 M C95947 0.160 M C95948 0.186 M C95950 0.065 M C95958 0.160 Mean 0.147 SEM 0.021 M C95962 0.130 M C95965 0.163 M I C95967 0.881 M C95968 0.096 jM C95977 0.162 Mean 0.286 SEM 0.149 Page 11-1 553 Table 11-1. Cell Proliferation in Rat Liver Covance 6329-225 Cova3nMceTS-6tu31d4y.1No. 6329-225 Dose Group 1 (Control - 0 ppm) 1 (Control - 0 ppm) 1 (Control - 0 ppm) 1 (Control - 0 ppm) 1 (Control - 0 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) Sex F F F F F I F F F F F 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) F F F F F 4 (High -100 ppm) F 4 (High -100 ppm) 4 (High -100 ppm) r f. F 4 (High -100 ppm) F 4 (High -100 ppm) ----------i------F- i ! --------------------------------------- i,------ ! PCNA Animal Labeling Number Index (%) C95985 0.179 C95987 0.153 C95988 0.298 C95997 0.215 C96000 0.181 Mean 0.205 SEM 0.025 C96002 0.244 C96003 0.749 C96006 0.285 C96008 0.253 C96010 0.122 Mean 0.330 SEM 0.108 C96021 0.088 C96023 0.063 C96026 0.099 C96027 0.181 C96038 0.062 Mean 0.099 SEM 0.022 C96045 0.032 C96046 0.128 C96048 0.121 C96049 0.152 C96056 0.128 Mean 0.112 SE M i 0.021 i i Page II-2 554 Covance 6329-225 3M T-6314.1 Final Cell Proliferation Report Covance Study Number 6329-225 Page 7 III. SIGNATURE PAGE Submitted by: Project Manager: Sandra R. Eldridge, Ph.D. Project Pathologist: -JS-no Date Carolyn Moyr, D.V.M., Diplomate, A.C.V.P. 555 Covance 6329-225 3M T-6314.1 Final Cell Proliferation Report Covance Study Number 6329-225 Page 8 IV. QUALITY ASSURANCE STATEMENT Pathology Associates International A Company of Science Applications International Corporation covance 6329-225 3M T-6314.1 AnBmpioyea-OwnadCoopany Cell Proliferation Report 13-Week Dietary Toxicity Study with N-Methyl Perfluoroctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Covance Study Number: 6329-225 QUALITY ASSURANCE STATEMENT This cell proliferation project has been inspected and audited by the PAI Quality Assurance Unit (QAU) as required by the Good Laboratory Practice (GLP) regulations promulgated by the U.S. Food and D rug Administration (FDA). The cell proliferation report is an accurate reflection o f the recorded data. The following table is a record o f the inspections/audits performed and reported by the QAU. Date of Insnection 12/23/98 04/03/00 04/03/00 05/12/00 Phase InsDected Date Findings R eported to PAI M anaeem ent/Proiect M anager Microtomy Study Data and Supporting Documentation Draft Cell Proliferation Report Final Cell Proliferation Report 12/23/98 04/03/00 04/03/00 05/12/00 Karen E. Butler Quality Assurance Officer - S ~ //A- jp o Date 557 15 Worman's Mill Court, Suite I Frederick, Maryland 217Q1 (301) 663-1644 (301) 663-8994 FAX Covance 6329-225 3M T-6314.1 Final Cell Proliferation Report Covance Study Number 6329-225 Page 9 APPENDIX I Individual Animal Findings Covance 6329-225 3M T-6314.1 COVANCE #6329-225 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Tissue: Liver ANIMAL NUMBER SEX DOSE GROUP HISTOLOGIC FINDINGS C96027 C96026 C96021 C96023 C96038 C95948 C95950 C95942 C95947 C95958 C95965 C95967 C95968 C95962 C95977 C96048 C96045 C960S6 C96049 C96046 C95985 C95997 C95988 C95987 C96000 C95909 C95902 C95918 C95905 C95906 F F F F F M M M M M M M M M M F F F F F' F F F F F M M M M M 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 1 1 1 1 1 1 1 1 1 1 No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings 559 Individual Animal Findings Covance 6329-225 3M T-6314.1 COVANCE #6329-225 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats Tissue: Liver ANIMAL NUMBER SEX DOSE GROUP HISTOLOGIC FINDINGS C95925 C95937 C95936 C95924 C95927 C96010 C96003 C96002 C96006 C96008 C96003 C96002 C96006 C96008 M M M M M F F F F F F F F F 2 2 2 2 2 2 2 2 2 2 2 2 2 2 No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings No Significant Findings 560