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COV/HC> ORIGINALTHE 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:
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Covance 6329-225 Sponsor Study Identification:
Study No. 3M T -6314.1
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Page 1 of 560
C00796
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QUALITY ASSURANCE STATEMENT
Covance 6329-225 3MT-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 06/02/9904/20/00 04/28/00 04/28/00
7us Representative Quality Assurance Unit
2
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STUDY IDENTIFICATION
Covance 6329-225 3MT-6314.1
13-W eek Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T -6314) in Rats
Test Material
N-Methyl Perfluorooctanesulfonamido Ethanol (MeFOSE, T-6314)
Sponsor
3M Toxicology Services Building 220-2E-02, 3M Center
St. Paul, Minnesota 55144-1000
Study Monitor
Andrew M. Seacat, PhD 3M Toxicology Services 651.575.3161
Alternate Study Monitor
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 D ate
August 27, 1998 September 1, 1998 December 2, 1998 June 30, 2000
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KEY PERSONNEL
Covance 6329-225 3MT-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
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Covance 6329-225 3M T-6314.1
CONTENTS
Page
ABSTRACT..................................................................................................................................... 8
PU RPO SE.............................................
11
REGULATORY COMPLIANCE...............................................................................................11
TEST M ATERIAL........................................................................................................................11 Test M aterial..............................................................................................................................11 Reserve (Archive) Sample........................................................................................................11 D isposition................................................................................................................................. 11
ANIMALS AND HUSBA N DRY ...............................................................................................12 Test Animal................................................................................................................................12 Identification...............................................................................................................................12 Acclim ation................................................................................................................................12 Housing and M aintenance....................................................................................................... 12 J u s tif ic a tio n ................................................................................................................................ 13
P R O C E D U R E S ..............................................................................................................................13
Group Designations and Dose Levels.....................................................................................13
Dose Preparation.......................................................................................................................14
Retention Sam ples.................................................................................................................... 15
M ethod o f Administration........................................................................................................15
Dose A nalyses........................................................................................................................... 15
Clinical O bservations................................................................................................................16
Body W eights............................................................................................................................ 16
Food Consum ption................................................................................................................... 16
Ophthalmology.......................................................................................................................... 17
Clinical Pathology............................................................................................
17
Serum Perfluorooctane Sulfonic Acid Level (PFOS) D eterm ination............................... 18
N ecropsy.....................................................................................................................................18
Organ W eights........................................................................................................................... 19
Cell Proliferation Tissue Collection and Immunohistochemical Evaluation....... ............. 19
Palmitoyl-CoA Oxidase Tissue Collection and Analyses.................................................... 19
Liver PFOS Analyses...................................................................
19
Tissue Preservation...................................................................................................................20
H istopathology..........................................................................................................................20
Statistical A nalyses................................................................................................................... 21
RECORD R E T E N T IO N ............................................................................................................. 21
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Covance 6329-225 3M T-6314.1
CONTENTS (Continued)
Page
RESULTS..................................................................................................................................... 22 Dose Analyses.......................................................................................................................... 22 Clinical Observations and Survival........................................................................................23 O p h th a lm o lo g y ......................................................................................................................... 23 Body W eights........................................................................................................................... 23 Food Consum ption.................................................................................................................. 23 Test Material Consumption.................................................................................................... 24 Clinical Pathology.................................................................................................................... 24 Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determ ination...............................25 Cell Proliferation Tissue Collection and Immunohistochemical Evaluation.................... 25 Liver PFOS Determination..................................................................................................... 25 Anatomic P athology............................................................................................................... 25
CONCLUSIONS......................................................................................................................... 26
SIGNATURES............................................................................................................................. 27
REFERENCES............................................................................................................................. 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 Chem istry.................................................................. 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 o f Body Weight Change Data ( g ) ................................................................. 61
8 Summary of Food Consumption Data (g ).....................
63
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CONTENTS (Continued)
Page
TABLES 9 Summary of Test Material Consumption D ata (m g/kg/day)......................................65 10 Summary o f Clinical Hematology Data - W eek 5.........................................................67 11 Summary o f Clinical Hematology Data- W eek 14........................................................71 12 Summary o f Clinical Chemistry Data - W eek 5 ............................................................ 75 13 Summary o f Clinical Chemistry Data - W eek 14...........................................................81 14 Summary o f Clinical Urinalysis D ata - W eek 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 D eviations................................................................................................................125 P r o t o c o l .....................................................................................................................................127 Protocol Amendment No. 1 .................................................................................................. 144 Protocol Amendment No. 2 .................................................................................................. 146 Protocol Amendment No. 3 .................................................................................................. 149
APPENDIX 2 ............................................................................................................................... 151 Individual Animal Fate D ata.................................................................................................. 152 Individual Clinical Observations...........................................................................................157 Individual Ophthalmic Observations.................................................................................... 173
APPENDIX 3 ...............................................................................................................................189 Individual Body Weight Data ( g ) ......................................................................................... 190
APPENDIX 4 ...............................................................................................................................201 Individual Food Consumption Data ( g ) .............................................................................. 202 Individual Test Material Consumption Data (mg/kg/day)................................................ 213
APPENDIX 5 ...............................................................................................................................223 Individual Clinical Hematology D a ta ...................................................................................224 Individual Clinical Chemistry D a ta ...................................................................................... 248 Individual Clinical Urinalysis D ata....................................................................................... 276
APPENDIX 6 ...............................................................................................................................288 Individual Anatomic Pathology D ata................................................................................... 289
APPENDIX 7 ................................................................................
546
Cell Proliferation R eport....................................................................................................... 547
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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. Water was provided ad libitum. The animals were observed twice daily (a.m. and p.m.) for mortality and moribundity. At least once weekly, each animal was removed from its cage and examined for abnormalities and signs o f toxicity. Body weight data were collected on the first day of treatment and weekly thereafter. Food consumption data were collected weekly. Ophthalmic examinations were done before initiation o f treatment and during 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 W eek 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.
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Covance 6329-225 3M T-6314.1
One female given 3 ppm N-MeFOSE was sacrificed on Day 59 due to severe laceration o f the tail. There were no macroscopic or microscopic changes to indicate that its moribund condition was test material-related. All other animals survived to the scheduled sacrifice. No clinical observations were noted that were considered to represent primary effects o f the test material Statistically significantly lower mean body weights were noted beginning at W eek 4 and continuing through the end of 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 W eek 13, food consumption was in general lower for males given 100 ppm. For females given 100 ppm, statistically lower food consumption was apparent at W eeks 3, 4, 6 ,7 ,1 1 , and 12.
Dietary administration o f 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 W eek 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 o f 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 fiver weight and mean liver-to-body weight percentage in females fed 30 ppm, and in all fiver weight parameters in males and females fed 100 ppm.
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Test material-reiated macroscopic findings were noted at a low incidence in the liver and glandular stomach o f males and females in the 100 ppm dose group only. Liver findings included organs that were large and diffusely dark. In the glandular stomach, dark foci or areas were sometimes seen in the gastric mucosa.
Test material-related microscopic findings were seen in the liver o f animals fed 30 and 100 ppm o f N-MeFOSE and in the glandular stomach o f males and females in the 100 ppm group only. No test material-related changes were seen in animals fed 3 ppm o f N-MeFOSE. In the liver, one or more test material-related findings affected all animals fed 100 ppm and included slight-to-moderate centrilobular or diffuse hepatocellular hypertrophy, minimal-to-slight coagulative necrosis, minimal hepatocellular pigment, and minimal-to-slight centrilobular to midzonal or diffuse hepatocellular vacuolation. In animals fed 30 ppm, centrilobular hepatocellular hypertrophy was also seen, although the incidence and severity was decreased at this dose. In addition, a low incidence o f minimal hepatocellular vacuolation occurred in 30 ppm dose group males, and the liver o f a single female fed 30 ppm had minimal coagulative necrosis. A possible test material-related change in the glandular stomach o f animals fed 100 ppm was a relatively low incidence 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 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.
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PURPOSE
Covance 6329-225 3M T-6314.1
The purpose o f this study was to assess the toxicity o f the test material, N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) when administered in the diet to rats for at least 13 weeks.
REGULATORY COMPLIANCE
All aspects 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 Material The test material, N-Methyl Perfluorooctanesulfonamido Ethanol (MeFOSE, T-6314), Lot No. F -l 1364, is an off white powder. It was received at Covance on August 3, 1995.
The test material was stored at room temperature.
Information on synthesis methods, stability, purity, composition, or other characteristics that define the test material is on file with the Sponsor.
Reserve (Archive) Sample A reserve sample (approximately 5 g) of the test material was taken and stored at room temperature. This sample will be transferred to the Sponsor after authorization from the Sponsor.
Disposition Remaining test material will be returned after authorization from the Sponsor.
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ANIMALS AND HUSBANDRY
Covance 6329-225 3M T-6314.1
Test Animal Male and female Crl:CD(SD) IGS BR rats were obtained from the Portage, Michigan, facility o f Charles River Laboratories, Inc., on August 17, 1998. The animals were 39 to 45 days old at initiation o f treatment. The males weighed from 184 to 236 g, and the females weighed from 140 to 179 g at initiation o f treatment.
Identification Each animal was assigned a temporary number upon arrival. Before initiation 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.
Acclimation Ninety-two males and 92 females were received on August 17, 1998, and acclimated in Animal Room 348 for 15 days before initiation o f treatment. In general, animals in this shipment appeared healthy. During acclimation, the animals were examined for abnormalities indicative of health problems, an ophthalmic examination was done, and body weights were recorded for all animals at randomization.
Housing and Maintenance Animal Room 348 was used for this study. Environmental controls for the animal room were set to maintain 18 to 26C, a relative humidity o f 30 to 70%, and a 12-hour light/12-hour dark cycle.
The animals were housed individually (except for the first 7 days o f acclimation when animals were group-housed) in stainless steel, screen-bottom cages.
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Covance 6329-225 3M T-6314.1
Certified rodent diet #5002 meal, (PM3 Nutrition International) was provided (see Protocol Deviations for exceptions) ad libitum, except when animals were fasted. The diet is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. The results are on file with Covance-Madison.
W ater was provided ad libitum. Samples o f the water are routinely analyzed for specified microorganisms and environmental contaminants. The results are on file with Covance-Madison.
There were no known contaminants in the diet or water at levels that would have interfered with this study.
Animals not selected for the study (12 males and 12 females) were removed from the study room and used for training procedures.
Justification Historically rats have been used in safety evaluation studies and are recommended by appropriate regulatory agencies.
PROCEDURES
This study was conducted in accordance with the Protocol dated August 27, 1998, and Protocol Amendment Nos. 1, 2, and 3. The protocol, protocol amendments, and protocol deviations are in Appendix 1.
Group Designations and Dose Levels The animals were examined by a laboratory animal veterinarian on August 31, 1998, and found to be suitable for study consideration. Selection o f animals for the study was based on clinical observations, body weights, ophthalmic examinations, and other data as appropriate. Animals were assigned to treatment groups using a computerized blocking procedure designed to achieve body weight balance with respect to treatment group. At the time o f randomization, the weight variation o f the animals for each sex used did not
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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 o f variance at the 5.0% probability level and found to be homogeneous. Animals were assigned to the study according to the following design:
Number o f Animals
Dietary Levels
Group
Male
Female
(ppm MeFOSE)3
1 (Control)1*
20
20
0
2 (Low)
20 20
3
3 (Mid)
20 20
30
4 (High)
20 20
100
a Dose levels were expressed as ppm o f MeFOSE.
b The control animals received the basal diet only.
Dose Preparation Dietary concentrations were based on the test material as supplied. Before initiation o f treatment, diets of 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 o f the diet and acetone was then mixed for 15 minutes.
P rep aratio n 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 of diet for Group 4 was transferred to the trench. The contents o f the mixing bowl were thoroughly mixed for 15 minutes.
P rep aratio n of D iet fo r G roup 4. A specified amount of 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 of approximately 5 mL acetone were added as necessary until the test material had dissolved. To prepare a premix, the diet was transferred into a labeled
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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 Samples During the in-life phase, samples (approximately 100 g) were taken from each dose preparation for dose analyses and stored at room temperature. These samples were discarded on M ay 11, 1999 (see Protocol Deviations for exceptions).
Method of Administration Dietary admixture was used because the potential route o f exposure in humans is oral.
The dose preparations were administered ad libitum for at least 13 weeks, unless otherwise specified.
Dose Analyses Analyses for the concentration o f test material in the dose preparations were done by Covance using an analytical method, MP-M324-MA, supplied by the Sponsor and validated by Covance.
Homogeneity was determined for the 3-ppm, 30-ppm, and 100-ppmdose preparations once pretest. One sample (approximately 100 g) each from the top, middle, and bottom o f the dose preparations mixed for homogeneity analyses were collected, divided into three subsamples for extraction and analysis, and analyzed for test material content. All samples were stored at room temperature until analyzed within 7 days o f mixing.
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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 of poor health or abnormal behavior were recorded as they were observed. At least once weekly, each animal was removed from its cage and examined. Any unusual or abnormal findings were recorded.
Body Weights Individual body weight data were recorded on the first day of treatment, and weekly thereafter.
Food Consumption
Individual food consumption data were recorded weekly during treatment. Food
consumption was not measured during Week 5 for animals scheduled for sacrifice during
W eek 5.
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O phthalm 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 Chem istry
aspartate aminotransferase alanine aminotransferase gamma glutamyltransferase calcium inorganic phosphorus sodium potassium chloride
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volume specific gravity pH protein glucose ketones
Covance 6329-225 3M T-6314.1
Urinalysis bilirubin blood urobilinogen microscopic examination of sediment appearance
Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination During W eeks 5 and 14, five animals/sex/group were fasted overnight, (see Protocol Deviations for exception) anesthetized with carbon dioxide, and blood (approximately 4 mL) was collected from a jugular vein. All samples were collected without anticoagulant, allowed to clot at room temperature, and centrifuged. Serum was harvested and stored in a freezer set to maintain -60 to -80C until packed on dry ice and shipped to the Sponsor for analyses. The samples were analyzed for PFOS. Results o f analyses will be reported separately by the Sponsor.
Necropsy A necropsy was done on the Group 2 female that was sacrificed at an unscheduled interval. During W eek 5, five animals/sex/group were fasted overnight (see Protocol Deviations for exception), anesthetized with carbon dioxide, bled for serum PFOS samples, weighed, and exsanguinated. These animals were discarded without necropsy. The liver was removed from these animals, weighed, and collected for palmitoyl CoA oxidase and PFOS analysis. During Week 14, the remaining animals were fasted overnight, anesthetized with carbon dioxide, bled for clinical pathology tests (10 animals/sex/group with the exception o f Group 2 female) and serum PFOS samples (five animals/sex/group), weighed, exsanguinated, and necropsied. Liver samples were collected for palmitoyl CoA oxidase, PCNA, and PFOS analysis. Animals were necropsied in random order.
The necropsy included a macroscopic examination of the external features o f the carcass; all external body orifices; the abdominal, thoracic, and cranial cavities; organs; and tissues.
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Covane* 6329-225 3M T-6314.1
Organ Weights After 13 weeks o f treatment, the foUowing organs (when present) were weighed; paired organs were 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 were calculated.
Cell Proliferation Tissue Collection and Immunohistochemical Evaluation At the terminal sacrifice, representative samples of 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.
Palmitoyl-CoA Oxidase Tissue Collection and Analyses At the scheduled sacrifices, the right lateral lobe of 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.
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
Histopathology Tissues (as appropriate) were embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically from each animal in the control and high-dose groups and from the low-dose animal that was sacrificed at an unscheduled interval. Due to microscopic findings noted in the high-dose group, the liver and stomach from animals in the mid-dose group, and the liver from animals in the low-dose group were also embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically.
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Macroscopic lesions from animals in the low- and mid-dose groups were embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically.
Bone marrow smears from the femur of each animal were prepared at the scheduled sacrifice after 13 weeks o f treatment, stained with Wright's stain, and retained for possible examination.
Statistical Analyses Levene's test (Levene, 1960) was done to test for variance homogeneity. In the case o f heterogeneity of variance at p <. 0.05, transformations were used to stabilize the variance. Comparison tests took variance heterogeneity into consideration.
One-way analysis of variance [ANOVA (Winer, 1971a)] was used 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 of 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.
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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 o f 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 W eek 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% o f 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.
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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.
Ophthalmology 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 W eek 14 examination.
Body Weights Body weight and body weight change data are summarized in Tables 6 and 7; individual body weight data are in Appendix 3.
Test material-related lower body weights were noted for males given 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 Consumption Food consumption data are summarized in Table 8; individual data are in Appendix 4.
23 C O O S iS
Covance 6329-225 3M T-6314.1
Although statistically significant only at W eek 13 for males given 100 ppm, food consumption was lower for males given 30 and 100 ppm when compared to those of controls for most o f the study. Females given 100 ppm had statistically significantly lower food consumption than those o f controls at Weeks 3, 4, 6, 7, 11, and 12. The overall mean food consumption for females fed the 100-ppm concentration was significantly lower by 17.5% when compared with that o f the controls.
Test Material Consumption Test material consumption data are summarized in Table 9; individual data are in Appendix 4.
Animals were fed diets containing 3, 30, or 100 ppm N-M eFOSE, T-6314. The mean amounts o f test material consumed by the animals in these groups were 0.148 to 0.304 mg/kg/day; 1.390 to 3.094 mg/kg/day; and 5.054 to 10.291 mg/kg/day for males, respectively. Values for females were 0.184 to 0.319 mg/kg/day; 2.204 to 3.395; and 6.494 to 10.378, respectively. The overall mean test material consumption for males fed diets containing 3, 30, or 100 ppm N-MeFOSE, T-6314 were 0 .2 0 3 ,2 .0 4 1 , and 6.844 mg/kg/day, respectively. The overall mean test material consumption for females fed diets containing 3, 30, or 100 ppm N-MeFOSE, T-6314 were 0.240, 2.588, and 7.702, respectively.
Clinical Pathology Hematology, clinical chemistry, and urinalysis data are summarized in Tables 10 through 14; individual data are in Appendix 5. The Pathology Report contains a discussion 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 of those on cholesterol and triglycerides for the high-dose males; those effects
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were considered to be of moderate severity. All o f the test material-related clinical pathology findings were more prominent at Week 14 than at W eek 5.
Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination Results o f serum PFOS level determination will be reported separately by the Sponsor.
Cell Proliferation Tissue Collection and Immunohistochemical Evaluation Results o f cell proliferation and immunohistochemical evaluation provided by Pathology Associates International are in Appendix 7.
Liver PFOS Determination Results o f liver PFOS level determination will be reported separately by the Sponsor.
Anatomic Pathology Terminal body weights, absolute organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios are summarized in Tables 15 and 16; incidences o f macroscopic and microscopic observations are summarized in Tables 17 and 18; the incidence o f severity o f microscopic observations is summarized in Table 19. Individual data are in Appendix 6. The Pathology Report contains a discussion o f the data.
Statistically significant and test material-related changes in terminal body weights and liver weights were seen in males and/or females in the two highest dose groups. Statistically significant decreases were seen in the terminal body weights o f males fed 30 ppm and in both males and females fed 100 ppm of N-MeFOSE. Statistically significant increases were seen in the mean liver-to-body weight percentage and mean liver-to-brain weight ratio in males fed 30 ppm, in mean absolute liver weight and mean liver-to-body weight percentage in females fed 30 ppm, and in all liver weight parameters in males and females fed 100 ppm.
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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-M eFOSE 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.
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SIGNATURES
Covance 6329-225 3M T -6314.1
NiTvan Bruce-Konuah Study Coordinator Covance Laboratories Inc.
Date
Covance Laboratories Inc.
c
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REFERENCES
Dunnett, C. W., "New Tables for Multiple Comparisons with a Control," Biometrics, 20:482-491 (1964).
Levene, H., "Robust Tests for Equality of Variances," Contributions to Probability and Statistics, (eds.) I. Olkin et al., Ch. 25, pp. 278-292, Stanford University Press: Stanford, California (1960).
Winer, B. J., "Design and Analysis o f Single-Factor Experiments," Statistical Principles in Experimental Design. Second Ed., Ch. 3, pp. 149-260, McGraw-Hill: New York, New York (1971a).
OPHTHALMOLOGY REPORT
Covance 6329-225 _____3M T-6314.I
Ophthalmic examinations were done before initiation o f treatm ent and during W eek 14.
Animals selected for the study had no lesions at the prestudy examination. No test material-related ophthalmic observations were noted at the W eek 14 examination.
t/UV-r-fN iDonna J. C lnons, DVM, MS
stornate, ACLAM
\<\ X o o o
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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 of 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 o r 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 W eek 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
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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 of 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 o f 0 (control group; fed basal diet only), 3, 30, or 300 ppm. During Week 5, five animals/sex/group were sacrificed to obtain liver samples for determination of hepatic palmitoyl CoA oxidase activity (by Covance) and analysis for PFOS and metabolites (by 3M). One female fed 3 ppm was sacrificed and necropsied during Week 9 because of poor health (unscheduled sacrifice). The remaining animals were sacrificed and necropsied during W eek 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 o f liver were collected at the terminal sacrifice for evaluation of proliferation cell nuclear antigen (PCNA; by Pathology Associates International; five animals/sex/group), and both scheduled sacrifices for determination of hepatic palmitoyl CoA oxidase activity (by Covance) and analysis for PFOS and metabolites (by 3M). Microscopic examinations were done on protocol-required tissues from all control and high-dose animals sacrificed during W eek 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
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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 AND DISCUSSION
Mortality One female fed 3 ppm (Animal No. C96016) was sacrificed during Week 9 (Day 59) because o f poor health. All other animals survived to the respective scheduled sacrifice.
Clinical Pathology W eeks 5 a n 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 of those on cholesterol and triglycerides for the males fed 100 ppm; those effects were considered to be of moderate severity. All o f the test material-related clinical pathology findings were more prominent at W eek 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.
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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 W eek 5 to Week 14). Other statistically significant differences were considered incidental and unrelated to administration o f the test material.
Anatomic Pathology Unscheduled D eaths. The one female fed 3 ppm that was sacrificed in a moribund condition on Day 59 (Animal No. C96016) had no macroscopic or microscopic changes to indicate that its moribund condition was test material-related.
Term inal Sacrifice Term inal Body W eights and O rgan W eights. Test material-related changes were seen in the terminal body weights and in absolute and relative liver weights in animals fed 30 and 100 ppm N-MeFOSE.
Mean terminal body weights were statistically significantly decreased in males and females that were fed 100 ppm of 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.
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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 14, 0 o f 15, and 3 o f 15 in females in the control, 3 ppm, 30 ppm, and 100 ppm groups respectively. The dark foci or areas generally correlated microscopically with small erosions in the glandular mucosa.
Diffuse reddening and mottling of 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 of animals fed 3 ppm.
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Test material-related findings in the liver included hepatocellular hypertrophy, coagulative necrosis, hepatocellular pigment, and hepatocellular vacuolation. The incidence and severity o f these findings tended to be greater in 100 ppm animals. The incidence o f pertinent liver findings is presented in Text Table 1.
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
0003
Pigment, hepatocellular
00 02
Vacuolation, hepatocellular,
centrilobular to midzonal
00 27
Vacuolation, hepatocellular, diffuse
0022
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 o f the 30 and 100 ppm dose groups, but in no other animals. Lastly, minimal to slight coagulative necrosis seen in 3 o f 15 males fed 100 ppm and 1 o f 15 females fed 30 ppm was likely related to dietary administration 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 o f mucosal erosions. The erosions were o f minimal to slight severity and involved a very small portion o f the mucosal surface in all cases. The erosions were seen with an
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incidence o f 0 o f 15, 0 o f 15, and 2 o f 15 in males, and at an incidence o f 0 o f 15, 0 o f 15, and 3 of 15 in females in the control, 30 ppm, and 100 ppm groups respectively. The presence 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 o f rats o f this age and strain.
Robert L. Hall, DVM, PhD Diplomate, ACVP (Clinical Pathology)
Diplomate, ACVP Diplomate, ABT
Date
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COMMENTS ON THE DATA
Covance 6329-225 3M T-6314.1
Various models o f calculators, computers, and computer programs were used to analyze data in this study. Because different models round off o r 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 o f incidences/animal, or the length o f time the condition persisted.
Only observations other than normal are indicated on the summary clinical observations tables.
Each animal with observations recorded as "Normal" throughout the study has the comment "Animal has no significant findings" indicated on the individual clinical observations tables.
The specific details for comments in the individual clinical observations tables that are indicated with a "C" can be found at the end 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 of a study week (e.g., a body weight recorded on Day 1 is considered a Week 1 body weight, a body weight recorded on Day 8 is considered a Week 2 body weight). 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.
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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 of 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[First Body Weight of lnterval+ (Daily Body Weight GainxDay Factor)]
where: Daily Body Weight Gain =
______ Last Body Weight of Interval- First Body Weight of Interval______ Day of Last Body Weight of Interval- Day of First Body Weight of Interval
and: Day Factor =
_ .^
Food Consumption Interval
(Food Consumption Start Day- Day of First Body Weight of interval) + ---------------- -----------------
and: Food Consumption Interval =
Food Consumption End Day- Food Consumption Start Day
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CODES, ABBREVIATIONS, AND UNITS
Covance 6329-225 3M T-6314.1
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, o f this information may be needed for this report.
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Covance 6329-225 3M T-6314.1
General Codes and Abbreviations
WK N Mean; MEAN SD; S.D.; STAND DEV;
STANDARD DEV; sd *
-; NA P C
UNSCHED DISPATCH
TBW # CO
Week. Number of measurements in a group. Arithmetic mean. Standard deviation.
Group mean is significantly different from the mean o f the control group (Group 1) at p <, 0.05.
No value; not applicable; not present. Present. Comment found at the end of each group
for each sex. Unscheduled. Observations transferred from the in-life
module of the data collection system to the necropsy module for reference during necropsy. Observations are duplicates of the last in-life observations. Terminal body weight. Number. Clinical observatioa
Animal Death Codes: 1 T M
Interim sacrifice 1. Terminal sacrifice. Sacrificed at an unscheduled interval.
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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 N o repeat (sample volume not sufficient for repeat analysis) Fibrin strands Sample clotted Slightly hemolyzed Hemolyzed Slightly lipemic Lipemic Slightly icteric Icteric Animal not fasted Unscheduled/moribund bleed Animal died on test Died during bleeding Technician judgment to repeat test Technical error (instrument or technician error that results in unacceptable data, e.g., unacceptable instrument output, sample spilled, entry o f invalid data) Recording error (recorded incorrect data, e.g., wrong number, spelling error, incorrect date) Entry error (incorrect keyboard entry) Sampling error Platelets clumped Platelets decreased Platelets increased Platelets large Platelets appear adequate Color interferes with test Heinz bodies observed Plasmodium No aggregation Fractious Unable to determine No coagulation
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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 (BASTEP) 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
URINE APPEARANCE
A Pale B Straw C Yellow D Dark yellow
Color
E Amber F Brown G Red H Green
I Black P Blue/green Q Blue R Orange
Clarity
J Clear K Hazy L Cloudy
Miscellaneous
M Debris O Feces
-0 0 3 3 7 42
Codes for Clinical Pathology (Continued)
Covance 6329-225 3M T-6314.1
URINE CHEMISTRY MULTISTIX STRIP
Urine Glucose
+ ++ +++ ++++
++-H -+
Negative 100 mg/dL 250 mg/dL 500 mg/dL 1,000 mg/dL 2,000 mg/dL
Urine Ketone
-
+ ++ +++ ++++ +++++
Negative 5 mg/dL 15 mg/dL 40 mg/dL 80 mg/dL 160 mg/dL
Urine Blood
- Negative + Small ++ Moderate +++ Large
Urine Urobilinogen
+ ++ +++ ++++
0.2 mg/dL 1 mg/dL 2 mg/dL 4 mg/dL 8 mg/dL
(1 mg = approximately 1 Ehrlich unit)
Urine Bilirubin
- Negative + Small ++ Moderate +++ Large
URINE SEDIMENT
Cells, Crystals, Casts, and Comments
A Amorphous urates B Amorphous phosphates C Uric acid D Triple phosphates E Calcium oxalate F Calcium carbonate G Granular casts H Hyaline casts I Cellular casts J Waxy casts K Unknown crystal P Mucous threads
Q Sperm R Fecal contamination S Pinworm ova found T Pinworm larvae found U Parasite ova found
0 Not present 1 1-5 per field 2 6-10 per field 3 11-20 per field 4 >20 per field
Bacteria
0 Not present 1 Few 2 Moderate 3 Many
C00338
43
Covance 6329-225 3M T-6314.1
Abbreviations and Units for Clinical Hematology
Test Red blood cell count Hemoglobin Hematocrit Mean corpuscular volume Mean corpuscular hemoglobin Mean corpuscular hemoglobin concentration Platelet count Mean platelet volume Reticulocyte count Absolute reticulocyte count Heinz body count Erythrocyte sedimentation rate Prothrombin time Activated partial thromboplastin time Thrombin time Activated coagulation time Fibrinogen Fibrin/fibrinogen degradation products Platelet aggregation
Collagen Adenosine diphosphate Alpha 2-antiplasmin Bleeding time Methemoglobin Plasma hemoglobin Myeloid/erythroid ratio Estimated myeloid/erythroid ratio White blood cell count Differential blood cell count Nucleated red blood cell count Corrected white blood cell count Segmented neutrophil count Band neutrophil count Lymphocyte count Monocyte count Eosinophil count Basophil count Anisocytosis Polychromasia
Abbreviation (Units) RBC (E6/UL or X106/L) HGB (G/DL) HCT (%) MCV (FL) MCH (PG) MCHC (%) PLT (E3/UL or X103///L) MPV (FL) RETIC (%) RETTC (E3/UL or X103//zL) 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///L)
NRBC (/100 WBC) COR WBC (E3/UL o r X103//JL) N-SEG (E3/UL or X IO ^ 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/uL) and % BASO (E3/UL or X103AL) and % ANISO (-,1,2,3) POLY (-,1,2,3)
00829 44
Covance 6329-225 3M T-6314.1
Abbreviations and Units for Clinical Hematology (Continued)
Test Poikilocytosis Hypochroxnasia Howell-Jolly bodies Basophilic stippling Toxic neutrophils Atypical lymphocytes
Aqueous white blood cell count (right eye) Aqueous white blood cell count (left eye)
A bbreviation (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)
co 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 BIL1 (MG/DL) D BILI (MG/DL) I BILI (MG/DL) CHOL (MG/DL) TRIG (MG/DL) UN/CREAT (RATIO) T LIPIDS (MG/DL) P LIPIDS (MG/DL) HDL (MG/DL) LDL (MG/DL) UA (MG/DL) AST/SGOT (IU/L) ALT/SGPT (IU/L) ALK PHOS (IU/L) GGT (IU/L) SDH (IU/L) LDH (IU/L) CK (IU/L) AMYLASE (IU/L) LIPASE (IU/L) PCOAO (IU/G) CA (MG/DL) ION CA (MG/DL) I PHOS (MG/DL) NA (MMOL/L) K (MMOL/L) CL (MMOL/L) MG (MEQ/L or MG/DL) ZN (MG/L or PPM) SR (MG/L or PPM) FE (UG/DL)
C 00341 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) TIBC (UG/DL) UIBC (UG/DL) FE %SAT (%) CHEP (MU/ML) CHER (MU/ML) CHEB (MU/ML) CAUD PUT (UMOL/G) HIPPOCAM (UMOL/G) F CORTEX (UMOL/G) CEREBELL (UMOL/G) BICARB (MMOL/L) SER HGB (MG/DL) SBA (UMOL/L or MG/DL) FBA (UG/ML) FCCW GT(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)
00342
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 of urine sediment Red blood cells per high-power field White blood cells per high-power field Epithelial cells per high-power field Bacteria per high-power field Casts per low-power field Crystals per low-power field
Urine appearance Comments
Abbreviation (Units) U VOL (ML) 8 HR VOL (ML) SPGR U OSMO (MOSM/KG) QUAN PRO (MG/DL)
PRO EXC (MG)
UPH U PRO (MG/DL) UGLU UKET U B IL I U BLOOD UROBILI U RE SUB
RBC (PER HPF) WBC (PER HPF) EPITH (PER HPF) BACT (PER HPF) CASTS (PER LPF) CRYSTALS (PER LPF1 or
PER LPF2) URINE APP1 or URINE APP2 COMMENTS
Miscellaneous Codes and Abbreviations for Clinical Pathology
Fecal occult blood Fecal parasite detection Hemolytic potential Osmolality
N ot applicable N ot applicable Not applicable OSMO (MOSM/KG)
48 C 0 0 3 4 3
Code
1 T M
Codes for Anatomic Pathology
Definition
ANIMAL DEATH CODES
Interim sacrifices 1 Terminal sacrifice Sacrificed at an unscheduled interval
Covance 6329-225 3M T-6314.1
EX NOT TAKEN MISSING UNSUITABLE AUTOLYTIC EXCLUDE
M ACROSCOPIC CODES
Indicates that organ weight is excluded from calculations Organ weight not taken; explanation given in necropsy notes Organ missing or lost Organ technically unsuitable for weighing Organ autolyzed and could not be weighed Weight was taken, but was excluded from all calculations
M ICROSCOPIC CODES
Codes Prefacing Neoplastic Findings B- Primary, benign neoplasm M- Primary, malignant neoplasm N- Metastatic neoplasm I- Locally invasive neoplasm X- Other neoplasm
Code
Definition
Distribution of Findings Focal Diffuse Multifocal
'1 0 3 4 4 49
Covance 6329-225 3M T-6314.1
Codes for Anatomic Pathology (Continued)
Grades for Severity or Amount 1 Minimal - the least amount of change that can be observed with the
light microscope 2 Slight - less than average amount o f change, but readily discernible
as abnormal 3 Moderate - the average amount o f change that is expected for a
lesion 4 Moderately severe (marked) - a marked amount of change with
possible loss of function of the affected cells or organs 5 Severe - a great amount of change with probable loss of function of
the affected cell or organs and frequently involves large areas o f the organ
Other Microscopic Codes TL Total P Finding present
Finding not present MN Mean
TISSUE ABBREVIATIONS
Abbreviation LN GL STOMACH, GL STOMACH, NONGL SALIV GL, MANDIB LN, ANT MES/PANC AUDITORY SEB GL LACRIMAL GLAND, EX HEMATO NEOPLASIA LACRIMAL GL, INT CAVITY, ABDOM SALIV GL,PAROTID LN, TRACHEOBRON
Definition Lymph node Gland Glandular stomach Nonglandular Mandibular salivary gland Anterior mesenteric/pancreatic lymph node Auditory sebaceous gland Exorbital lacrimal gland Hematopoietic neoplasia Internal lacrimal gland Abdominal cavity Parotid salivary gland Tracheobronchial lymph node
COOS'-5
50
Table 1
Covance 6329-225 3M T-6314.1
Results of Homogeneity Analyses (ppm) Mixed 8/20/98
13-WEEKDIETARYTOXICITY STUDY WITHN-METHYLPERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T6314) IN RATS
Samples Location Replicate 3
T6314 (ppm) 30 100
Top
1 2.19
33.7 79.4
2 2.43
27.8 76.5
3 2.09
25.6 76.7
Mean 2.24 (74.7)a 29.0 (96.7) 77.5 (77.5)
Middle
1 2 3 Mean
2.24 2.27 2.14 2.22 (74.0)
25.2 25.3 25.1 25.2 (84.0)
75.0 79.7 89.5 81.4 (81.4)
Bottom
1 2 3 Mean
2.03 3.04 1.94 2.34 (78.0)
23.7 27.6 29.4 26.9 (89.7)
83.2 81.6 87.8 84.2 (84.2)
a Each value in parenthesis is the percent o f theoretical.
51
Covance 6329-225 3M T-6314.1
Table 2
Results of Stability Analyses (ppm) Mixed 8/20/98
13-WEEKDIETARYTOXICITY STUDYWITHN-METHYLPERFLUOROOCTANESULFONAMIDO 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 temprature5
1 2 Mean
0.709 0.850 0.780 (78.0)
-
8 week, frozen
1 2 Mean
0.779 0.995 0.887 (88.7)
_ -
a Each value in the parenthesis is the percent o f theoretical b Reinjected
c 00S4 52
Covance 6329-225 3M T-6314.1
Table 2 (Continued)
Results of Stability Analyses (ppm) Mixed 9/24/98
13-WEEK DIETARY TOXICITY STUDY WITHN-METHYLPERFLUOROOCTANESULFONAMIDO ETHANOL(N-MeFOSE, T6314) IN RATS
T6314 (ppm)
Storage Conditions Replicate 500
1
Initial
1 2 Mean
0.788 0.656 0.722 (72.2)a
19 day, room temperature
1 2 Mean
0.707 0.651 0.679 (67.9)
32 days, room temperature
1 2 Mean
0.688 0.657 0.673 (67.3)
a Each value in the parenthesis is the percent o f theoretical.
C00348
53
Covance 6329-225 3M T-6314.1
Table 2 (Continued)
Results o f Stability Analyses (ppm) Mixed 10/22/98
13-WEEKDIETARY TOXICITYSTUDY WITHN-METHYLPERFLUOROOCTANESULFONAMIDO 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.
C00849
54
Table 3
Covance 6329-225 3M T-6314.1
Results of Dose Preparation Analyses (ppm)
13-WEEK DIETARY TOXICITY STUDY WITHN-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Week Replicate 0
3
T-6314 (ppm) 30
100
1-4 1 a 2.16 29.7 87.3
2 a 2.12 27.0 85.2
Mean -
2.14 (71.3)b 28.4 (94.7) 86.3 (86.3)
1-4C
1 2 Mean
_
-
-
1.98 1.84 1.91 (63.7)
_ -
-
-
l-4d
1 2 Mean
_ -
2.48 2.28 2.38 (79.3)
-
-
_ -
5-8 1 a 3.55
27.9 89.3
2 a 3.05
27.0 82.3
Mean a
3.30(110) 27.5 (91.7) 85.8 (85.8)
9/12 1 a 2.24
27.6 89.7
2 a 2.49 26.8 87.2
Mean a
2.37 (79.0) 27.2 (90.7) 88.5 (88.5)
13/14
1 2 Mean
a a a
2.51 2.42 2.47 (82.3)
26.2 26.4 26.3 (87.7)
98.1 98.7 98.4 (98.4)
a Below the limit o f quantitation (<0.5 ppm), b Each value in parenthesis is the percent o f theoretical, c Retest, d Retention.
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
--- M A L E ------- -- --FEMALE-- 12 3 4 12 34 0 3 30 100 0 3 30 100
20 20 20 20 20 20 20 20
00001000 36341331 00000001 00010000 00001000 01000000
10000000 00 01 0 0 00
00 010 0 00
0001 0000
Covance 6329-225 3M T-6314.1
PAGE: 1
DAYS 1-93
CATEGORY KEYWORD QUALIFIER
SKIN Sc 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
--- MALE-- -- 1234 0 3 30 100
-- ---F EMALE-- 12 3 0 3 30
4 100
20 20 20 20 20 20 20 20
10000000
00000010 00000100
00100000
' "S
o
*CO-'i
57
Covance 6329-225 3M T-6314.1
PAGE: 2
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
-- m iLE--
12 34
0 3 30 100
-- FEt1ALE-- 1234 0 3 30 100
15 15 15 15 15 15 15 15
01000000 00010000
00100000
Covance 6329-225 3M T-6314.1
PAGE: 1
o
U3 C1 U
58
Table 6 Summary of Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
WEEK
SEX: GROUP:
DOSE: UNITS:
1 0 PPM
---------- MALE 2 3
PPM
3 30 PPM
i
2
3
4
5
6 >
7 6 G3
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.
20 210
11.2
20 263
16.0
20 313
21.5
20 355
25.1
20 385
28.6
15 410
24.4
15 435
24.5
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
FEMALE2 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
Table 6 Summary of Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOHOOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
WEEK
SEX: GROUP :
DOSE: UNITS:
1 0 PPM
----------- MA jE---------
23
3 30
PPM
PPM
8
9
10
11
12
13
14
O
o
GO C/i U\
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.
15 452
26.9
15 475
28.1
15 490
29.7
15 503
33.0
15 516
34.1
15 532
36.1
15 547
38.6
15 439
27.0
15 461
25.8
15 475
28.4
15 485
31.9
15 496
30.6
15 510
30.0
15 521
27.6
15 428*
28.6
15 448*
28.4
15 460*
30.2
15 471*
31.9
15 480*
33.8
15 490*
30.1
15 491*
37.1
4 100 PPM
15 416*
22.9
15 430*
24.6
15 442*
23.7
15 453*
24.9
15 462*
24.8
15 471*
25.1
15 481*
25.3
1 0 PPM
15 259
26.8
15 267
26.3
15 275
29.2
15 281
31.3
15 287
33.2
15 293
36.2
15 300
35.9
FEMALE 2 3 PPM
3 30 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
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
60
Covance 6329-225 3M T-6314.1
PAGE: 2
Table 7 Summary of Body Weight Change Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
WEEK
SEX: GROUP :
DOSE: UNITS:
i 0 PPM
1-2 N MEAN S.D.
2-3 N MEAN S.D.
3-4 N MEAN S.D.
4-5 N MEAN S.D.
5-6 N MEAN S.D.
6-7 N MEAN S.D.
7-8 N MEAN S.D.
20 53
6.5
20 49
9.3
20 42 10.4
20 31
7.6
15 19
7.8
15 26
3.3
15 16
4.3
--------- MALE2 3
PPM
3 30 PPM
20 52
5.4
20 51
5.6
20 41
5.5
20 27
3.6
15 17
3.9
15 23
4.4
15 15
4.9
20 53
4.6
20 49
5.0
20 39
5.2
20 26
4.9
15 17
4.7
15 21*
3.6
15 14
8.1
4 100 PPM
20 50
3.8
20 45*
4.6
20 32*
4.1
20 24*
6.1
15 14
4.9
15 24
6.2
15 13
3.8
1 0 PPM
20 26
6.7
20 19
8.5
20 21
9.3
20 11
7.6
15 7 6.8
15 9 5.3
15 4 5.1
-------- FEMALE2 3
PPM
3 30 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.
20 16
7.
20 13*
7.
20 8 4.
15 7 4.
15 6 3.
15 2 4.
r*>
O tn m
61
Covance 6329-225 3M T-6314.1
PAGE: 1
Table 7 Summary of Body Weight Change Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
WEEK
SEX: GROUP :
DOSE: UNITS:
1 0 PPM
--------- 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
FEMALE' 2 3 PPM
3 30 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
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
S80G0
62
Table 8 Summary of Food Consumption Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
WEEK
SEX: GROUP:
DOSE: UNITS:
-
1 0 PPM
---------- MALE2 3
PPM
3 30 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
FEMALE2
3 PPM
3 30 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
O035 S
63
Table 8 Summary of Food Consumption Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS
WEEK
SEX: GROUP :
DOSE: UNITS:
-----------MALE123 0 3 30 PPM PPM 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
12 188
12.6
15 189
16.6
15 180
27.5
15 183
17.5
15 181
19.4
15 178
12.3
10 2329
115.5
14 179
15.2
15 180
19.6
15 176
18.8
14 176
22.1
15 175
19.4
15 160
46.1
13 2271
145.8
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
--------- FEMALE 12 3 0 3 30 PPM PPM 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
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
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.
14 118
15.
14 115
13.
13 112*
12.
14 114*
13.
14 119
26.
10 1505*
173.
Covance 6329-225 3M T-6314.1
PAGE: 2
Table 9 Summary of Test Material Consumption Data (mg/kg/day)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
WEEK
SEX: GROUP:
DOSE: UNITS:
2 3 PPM
----- MAL E ---3
30 PPM
4 100 PPM
i
2
3
4
5
6
7
'w- y O ce
&o
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.
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
2 3 PPM
---- FEMALE--3
30 PPM
4 100 PPM
16 0.319 0.040
16 0.273 0.042
16 0.269 0.027
16 0.252 0.015
12 0.226 0.012
13 0.236 0.030
12 0.247 0.051
17 3.395 0.601
13 3.028 0.512
16 2.861 0.393
13 2.570 0.170
8 2.262 0.188
12 2.662 0.337
6 2.348 0.140
18 10.378
1.400
16 8.867 1.027
19 8.142 0.679
20 8.219 0.997
15 7.464 0.685
15 7.675 0.703
14 7.325 0.627
65
Covance 6329-225 3M T-6314.1
PAGE: 1
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
GROUP : DOSE:
WEEK UNITS:
2 3 PPM
8 9 10 11 12 13 1-13
N MEAN S.D.
N MEAN S.D.
N MEAN S.D.
N MEAN S.D.
N MEAN S.D.
N MEAN S.D.
MEAN
12 0.178 0.010
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
3 30 PPM
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
4 100 PPM
15 5.946 0.210
15 5.749 0.216
15 5.554 0.211
14 5.369 0.281
15 5.301 0.248
15 5.054 0.196
6.844
2 3 PPM
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
3 30 PPM
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
4 100 PPM
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
O ce o
66
Covance 6329-225 3M T-6314.1
PAGE: 2
Table 10
Summary of Clinical Hematology Data
Males
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
DOSE ppm MeFOS
RBC X1 0 6/m L
HGB G/DL
HCT %
MCV FL
MCH PG
MCHC %
PLT X 1 0 3/aL
0
MEAN S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
8.18 .424 10
8.14 .427 10
8.24 .477 10
7.99 .303 10
16.2 .66 10
16.4 .47 10
16.3 .38 10
15.9 .71 10
47.0 2.04 10
47.5 1.70 10
47.1 1.64 10
46.0 1.71 10
57.4 1.97 10
58.4 1.77 10
57.2 1.93 10
57.6 1.86 10
19.8 .42 10
20.1 .73 10
19.8 .81 10
19.9 .76 10
34.5 .61 10
34.4 .51 10
34.7 .52 10
34.5 .45 10
1173 61.5 10
1151 136.0 10
1038 * 96.9 10
1081 112.7 10
Covance 6329-225 3M T-6314.1
O 03 &
67
DOSE ppm MeFOS
WBC X103/m L
Table 10
Summary of Clinical Hematology Data
Males
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
N-SEG
LYMPH
xioV m - X103/^L
MONO
EOSIN
BASO
x io V ml X103/VL XIOVjUL
N-SEG%
LYMPH%
MONO%
EOSIN%
Covance 6329-225 3M T-6314.1
BASO%
0
MEAN
9.1
.6 7.9
.4
.1
.0
7 87
5
1
0
S.D.
1.96
.14 1.86
.15
.03
.00
2.1 2.2 1.3
.3
3
N 10 10 10 10 10 10 10 10 10 10 10
3
MEAN
9.1
.6 8.0
.4
.1 .0
S.D.
1.74
.10 1.64
.20
.05
.00
06 88 5 1 0
1.6 3.5 1.9
.7
N 10 10 10 10 10 10 10 10 10 10 10
30
MEAN
10.0
.5 9.0
.4
.1
.0
5 90
4
1
0
S.D.
2.48
.15 2.27
.13
.06
.04
1.4 1.8 1.1
.3
4
N 10 10 10 10 10 10 10 10 10 10 10
100
MEAN
10.7
.9 9.0
.6 .1 .0
9 84
6
1
0
S.D.
3.51
.40 3.17
.20
.03
.05
3.6 4.2 1.3
.3
5
N 10 10 10 10 10 10 10 10 10 10 10
C-OOSG
68
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 ppm MeFOS
RBC X10%L
HGB G/DL
HCT %
MCV FL
MCH MCHC
PLT
PG % X l O V n 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 104.4 10
1178 82.3 10
1123 121.8 10
1058 217.2 10
Covance 6329-225 3M T-6314.1
frS B O O O
69
DOSE ppm MeFOS
WBC XIOViiL
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 X103/m L
LYMPH X 1 0 3/>Uj
MONO
EOSIN
BASO
X103/m L X l O ^ / h X103/*tL
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
51
0
S.D.
1.59
.29 1.32
.15
.05
.00
3.1 4.5 1.5
.3
3
N 10 10 10 10 10 10 10 10 10 10 io"
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
.0
N 10 10 10 10 10 10 10 10 10 10 io'
100
MEAN
7.3
.5 6.4
.4
.1
.0
7 87
5
1
0
S.D.
2.09
.18 1.96
.27
.04
.03
3.7 4.5 2.3
.3
.3
N 10 10 10 10 10 10 10 10 10 10 10
o
05 0 01
70
Table 11
Summary of Clinical Hematology Data
Males
Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
DOSE ppm MeFOS
RBC X 1 0 6/>L
HGB G/DL
HCT %
MCV FL
MCH PG
MCHC %
PLT xioV ml
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 119.5 10
1060 73.0 10
1000 140.3 10
1011 138.4 10
Covance 6329-225 3M T-6314.1
o
G3
& &
71
DOSE ppm MeFOS
WBC XIOVliL
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
N-SEG
LYMPH
X103///L X1 0 3//jL
MONO X 103/m L
EOSIN
BASO
X103/m D X1 0 3/AL
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
(2 &
72
ov'--V
C3
600
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 ppm MeFOS
RBC X1 0 6/m L
HGB G/DL
HCT %
MCV FL
MCH PG
MCHC %
PLT X1 0 3/m L
0 MEAN S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
7.76 .178 10
14.8 .45 10
8.07 .330 9
15.1 .75 9
8.09 * .343 10
15.1 .56 10
7.69 .289 10
14.2 .67 10
45.1 .95 10
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 103.3 10
1073 108.7 9
980 97.8 10
1056 110.7 10
Covance 6329-225 3M T-6314.1
73
DOSE ppm MeFOS
WBC XloV^iL
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 x i o 3/m l
LYMPH x i o 3/^l
MONO X 103/m L
EOS IN
BASO
X103/m L x i o 3//^l
N-SEG%
LYMPH%
MONO%
EOSIN%
Covance 6329-225 3M T-6314.1
BASO%
0
MEAN
4.0
.8 3.0
.2
.1 .0 19 74
5
2
0
S.D. .95 .47 .69 .12 .03 .00
8.5 8.8 2.8
.6
4
N 10 10 10 10 10 10 10 10 10 10 10
3
MEAN
4.7
.7 3.7
.3
.1 .0 15 77
6
2
0
0S.D.
1.27
.18 1.27
.05
.00 .00
5.3 6.4 1.3
.8
N 99999999999
30
MEAN
5.7
1.0
4.4
.3 *
.1
.0
17
76
5
1*
0
S.D.
1.08
.49 1.10
.10
.00
.03
7.6 8.0 1.7
.5
3
N 10 10 10 10 10 10 10 10 10 10 10
100
MEAN
4.7
.6 3.8
.2
.1
.0 14 80
4
2
0
S.D.
2.03
.28 1.89
.09
.04
.00
7.0 8.4 1.8
.7
3
N 10 10 10 10 10 10 10 10 10 10 10
380 0
<0
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
103
11
.6 6.9 4.7 2.2
S.D.
5.7 1.9 .07 .39 .23 .26
N 10 10 10 10 10 10
.2 .00 10
3
MEAN
114
11
.6 6.9 4.7 2.1
S.D. 14.1 1.4 .05 .23 .19 .14
N 10 10 10 10 10 10
.2 .00 10
30
MEAN
106
12
.6
6.6
4.7
2.0 *
.2
S.D. 15.6 1.7 .03 .22 .14 .19 .03
N 10 10 10 10 10 10 10
100
MEAN
106
13 *
.6
6.7
4.7
2.0 *
.2
S.D.
17.5
1.6 .07
.29
.21
.18
.00
N 10 10 10 10 10 10 10
59 15.4 10
58 12.1 10
54 10.6 10
44 14.1 10
45 18.3 10
55 18.8 10
40 10.4 10
25 * 9.9
10
C00Q70
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 os
AST/SGOT ALT/SGPT
IU/L
IU/L
GGT IU/L
CA MG/DL
I PHOS MG/DL
NA MMOL/L
MMOL/L
CL MMOL/L
MEAN S.D. N
MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
103 18.9 10
96 16.1 10
101 18.3 10
97 12.2 10
32 3.6
10
33 4.6
10
32 3.8
10
40 * 4.5
10
0 5
10
10.9 .47 10
0 .5
10
10.8 .19 10
0 ,7
10
10.5 .30 10
0 .3
10
10.6 .42 10
9.5 .61 10
9.8 .71 10
9.0 .78 10
9.0 1.02
10
147 1.3
10
147 1.6
10
148 1.2
10
147 2.5
10
6.2 .39 10
6.2 .42 10
6.1 .52 10
6.1 .46 10
105 2
10
105 1
10
106 1
10
105 2
10
Covance 6329-225 3M T-6314.1
C10371
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 S.D.
108 8.9
12 2.1
.7 7.4 .04 .47
5.3 .39
2.1 .24
.2 69 28
.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
ft
O CO v]
77
Table 12
Summary of Clinical Chemistry Data
Females
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
DOSE ppm MeFOS
AST/SGOT ALT/SGPT
IU/L
IU/L
GGT IU/L
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
MEAN S.D, N
MEAN S.D. N
MEAN S.D. N
100 MEAN S.D. N
99 15.3 10
93 7.5
10
93 14.0 10
93 16.0 10
28 4.8
10
27 4.9
10
28 3.5
10
30 5.8
10
0 .5
10
10.8 .52 10
0 .7
10
10.7 .40 10
1 1.1 10
10.8 .38 10
1 .8
10
10.6 .32 10
7.9 .65 10
8.2 .77 10
7.7 1.07
10
8.2 1.06
10
146 1.3
10
147 1.6
10
146 1.9
10
147 2.0
10
6.0 .31 10
5.8 .39 10
6.0 .60 10
5.8 .52 10
105 1
10
105 1
10
104 1
10
106 2
10
Covance 6329-225 3M T-6314.1
GO0373
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
C00374
79
Table 12
Summary of Clinical Chemistry Data
Females
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
DOSE ppm MeFOS
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
ii 2.7 5
Covance 6329-225 3M T-6314.1
C00375
80
rsS o
C3
DOSE ppm MeFOS
Table 13
Summary of Clinical Chemistry Data
Hales
Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS
GLU MG/DL
UN MG/DL
CREAT HG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL HG/DL
Covance 6329-225 3H T-6314.1
TRIG HG/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
ai
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 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
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
2 .7
10
10.2 .40 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
oo
u3
82
DOSE ppm MeFOS
Table 13
Summary of Clinical Chemistry Data
Females
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 S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
119 10.6 10
121 8.0 9
110 7.0
10
110 9.2
10
12 2.0
10
13 2.1 9
14 1.8
10
17 * 2.1
10
.8 .07 10
.8 .07
9
.8 .07 10
.8 .06 10
7.9 .50 10
7.7 .53 9
8.0 .42 10
8.2 .50 10
5.8 .41 10
5.6 .42 9
5.8 .24 10
6.0 .36 10
2.1 .31 10
2.1 .24 9
2.2 .28 10
2.1 .23 10
.2 .03 10
.2 * .05
9
.2 .03 10
.2 .00 10
73 12.6 10
69 9.4 9
70 9.9
10
51 * 17.7 10
43 16.8 10
38 21.5
9
36 12.7 10
25 4.2
10
C00373
83
o Sr* o i3
CD
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 2.7
10
111 3.3 9
109 2.6
10
109 3.0
10
Covance 6329-225 3M T-6314.1
84
o
o
C3
e(JO
Table 13 Summary of Clinical Chemistry Data
Males
Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
DOSE ppm MeFOS
PCOAO IU/G
0
3 30 100
MEAN S.D. N
MEAN S.D. N
MEAN S.D. N
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
Table 13
Sununary 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
PCOAO IU/G
0
MEAN S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
7 2.5 15
7 2.9 14
9 2.8 15
20 * 6.7
15
Covance 6329-225 3M T-6314.1
C00381
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
10.6 5.52 10
13.8 13.29
10
21.0 16.52
10
1.036 .0179 10
1.026 .0093 10
1.026 .0162 10
1.024 .0148 10
6.9 .32 10
6.9 .39 10
6.8 .42 10
6.6 .24 10
Covance 6329-225 3M T-6314.1
SGOiy-3
N
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
CS8000
88
I
TABLE 15 Summary of Organ Weight Data
Covance 6329-225 3M T-6314.1
Week 5 Sacrifice
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 1
T
AB
LE SE
INCLUDES: X =ALL;GROU
P
=
A
LL
;
W
E
EK
S=
A
LL
D E A T H = 1 ;SUBSET=T
SEX DOSE GROUP
M1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
<g>
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
5 335.2
45.6
5 10.7554
2.0653
5 3.1879 0.2295
M2
NUMBER IN GROUP MEAN
STANDARD DEV
5 340.9
18.5
5 10.9504
0.9661
5 3.2077 0.1326
M3
NUMBER IN GROUP MEAN
STANDARD DEV
5 347.4
26.9
5 13.1250
1.4559
5 3.7790 0.3232
LIVER
SEX DOSE GROUP
F1 NUMBER IN GROUP
MEAN STANDARD DEV
F2
NUMBER IN GROUP MEAN
STANDARD DEV
F3
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT
(%)
5 198.2
13.8
5 6.3023 0.5865
5 3.1778 0.1457
5 216.0
15.1
5 7.2592 0.4951
5 3.3620 0.0692
5 214.4
12.5
5 7.6187 0.7637
5 3.5493 0.2091
frS S O O O
89
TABLE 15 Summary of Organ Weight Data
Week 5 Sacrifice
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Covance 6329-225 3M T-6314.1
PAGE: 2
TABLE INCLUDES: S E X = A L L ;G R O U P = A L L ; W E E K S = A L L
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
V-'
O 03 CO CA
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
SEX DOSE GROUP
M1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
<g)
ORGAN WEIGHT
(g)
15 505.3
35.7
15 0.0562 0.0092
M2
NUMBER IN GROUP MEAN
STANDARD DEV
15 482.1
27.7
15 0.0575 0.0083
M3
NUMBER IN GROUP MEAN
STANDARD DEV
15 460.1*
31.8
15 0.0551 0.0088
ADRENAL
ORGAN-TOBODY WT (%)
15 0.0112 0.0020
ORGAN-TOBRAIN WT
RATIO
15 0.0258 0.0044
SEX DOSE GROUP
F1
NUMBER IN GROUP MEAN
STANDARD DEV
15 0.0120 0.0020
15 0.0267 0.0038
F2
NUMBER IN GROUP MEAN
STANDARD DEV
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
COOS 8 6
91
TABLE 16 Summary of Organ Weight Data
Week 14 Sacrifice
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Covance 6329-225 3M T-6314.1
PAGE: 2
TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL
SEX DOSE GROUP
M4
TERMINAL BODY WT
(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
0083
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: S E X = A L L ;G R O U P = A L L ;W E E K S = A L L DEATH=T;SUBSET=ALL
BRAIN
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
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
M2
NUMBER IN GROUP MEAN
STANDARD DEV
15 482.1
27.7
15 2.1519 0.0910
15 0.4480 0.0354
15 1.0000 0.0000
F2
NUMBER IN GROUP MEAN
STANDARD DEV
M3
NUMBER IN GROUP MEAN
STANDARD DEV
15 460.1*
31.8
15 2.1680 0.0768
15 0.4731* 0.0323
15 1.0000 0.0000
F3
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
15 270.5
33.3
15 1.9434 0.1049
15 0.7256 0.0712
15 1.0000 0.0000
14 251.3
24.0
14 1.9678 0.0694
14 0.7891* 0.0733
14 1.0000 0.0000
15 253.4
17.8
15 2.0183 0.0826
15 0.7995* 0.0538
15 1.0000 0.0000
C0033S
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
15 1.0000 0.0000
Ci .'"5 o C3 C0
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
r
o
C5 CD O
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
(3)
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
G3
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: S E X = A L L ;G R O U P = A L L ;W E E K S = A L L 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 14.5017
1.6903
M2
NUMBER IN GROUP MEAN
STANDARD DEV
15 482.1
27.7
15 14.3465
1.3494
M3
NUMBER IN GROUP MEAN
STANDARD DEV
15 460.1*
31.8
15 15.9014
1.5170
LIVER
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
15 2.9803 0.2896
15 6.6774 0.6795
F2
NUMBER IN GROUP MEAN
STANDARD DEV
15 3.4572* 0.2312
15 7.3423* 0.7472
F3
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
15 270.5
33.3
15 8.0512 1.3405
15 2.9775 0.3423
15 4.1397 0.6146
14 251.3
24.0
14 7.8673 0.9141
14 3.1298 0.2035
14 3.9983 0.4464
15 253.4
17.8
15 9.2512* 0.7652
15 3.6610* 0.3281
15 4.5878 0.3853
o
3 w
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: S E X = A L L ;G R O U P = A L L ;W E E K S = A L L DEATH=T;SUBSET=ALL
SEX DOSE GROUP
M4
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(g)
LIVER
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 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
r> *% o
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: S E X = A L L ;G R O U P = A L L ;W E E K S = A L L DEATH=T;SUBSET=ALL
OVARY
SEX DOSE GROUP
M1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
15 505.3
35.7
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F1
NUMBER IN GROUP MEAN
STANDARD DEV
M2
NUMBER IN GROUP MEAN
STANDARD DEV
15 482.1
27.7
F2
NUMBER IN GROUP MEAN
STANDARD DEV
M3
NUMBER IN GROUP MEAN
STANDARD DEV
15 460.1*
31.8
F3
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
O)
ORGAN WEIGHT
<g>
ORGAN-TOBODY WT <%)
ORGAN-TOBRAIN WT
RATIO
15 270.5
33.3
15 0.1280 0.0205
15 0.0480 0.0097
15 0.0658 0.0096
14 251.3
24.0
14 0.1225 0.0227
14 0.0489 0.0081
14 0.0624 0.0117
15 253.4
17.8
15 0.1221
0.0215
15 0.0486 0.0109
15 0.0605 0.0109
03 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: S E X = A L L ;G R O U P = A L L ;W E E K S = A L L DEATH=T;SUBSET=ALL
SEX DOSE GROUP
M4
TERMINAL BODY WT
(g>
ORGAN WEIGHT
(g)
OVARY
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
15 445.8*
24.4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
15 229.8*
22.7
15 0.1206 0.0238
15 0.0527 0.0099
15 0.0592
0.0107
SGCOOO
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
Covanee 6329-225 3M T-6314.1
PAGE: 11
TABLE INCLUDES: S E X = A L L ;G R O U P = A L L ;W E E K S = A L L DEATH=T;SUBSET=ALL
SPLEEN
SEX DOSE GROUP
M1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(3)
ORGAN WEIGHT
(3)
15 505.3
35.7
15 0.8041 0.0904
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
M2
NUMBER IN GROUP MEAN
STANDARD DEV
15 482.1
27.7
15 0.7666 0.1431
15 0.1597 0.0332
15 0.3558 0.0604
F2
NUMBER IN GROUP MEAN
STANDARD DEV
M3
NUMBER IN GROUP MEAN
STANDARD DEV
15 460.1*
31.8
15 0.7341 0.0802
15 0.1602 0.0203
15 0.3390 0.0390
F3
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(3)
ORGAN WEIGHT
(3)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
15 270.5
33.3
15 0.5153 0.1324
15 0.1907 0.0408
15 0.2649 0.0644
14 251.3
24.0
14 0.5235 0.0643
14 0.2090 0.0239
14 0.2658 0.0290
15 253.4
17.8
15 0.5166 0.0506
15 0.2049 0.0251
15 0.2568 0.0306
<T>
oW
03 m
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: S E X = A L L ;G R O U P = A L L ;W E E K S = A L L 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
GROOO
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: S E X =ALL;GROUP=ALL;WEEKS=ALL D E ATH=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
r> w* O Q 00
103
TABLE 16 Summary of Organ Weight Data
Week 14 Sacrifice
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Covance 6329-225 3M T-6314.1
PAGE: 14
TABLE INCLUDES: S E X =ALL;GROUP=ALL;WEEKS=ALL
D E A T H = T ;SUBSET=ALL
SEX DOSE GROUP
M4
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
TESTIS
ORGAN-TOBODY WT
<%>
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
15 445.8*
24.4
15 3.4789 0.2974
15 0.7824* 0.0756
15 1.6042 0.1126
NUMBER IN GROUP: MEAN:
STANDARD DEV:
15 229.8
22.7
n
Q
104
TABLE 16 Summary of Organ Weight Data
Week 14 Sacrifice
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Covance 6329-225 3M T-6314.1
PAGE: 15
TABLE INCLUDES: S E X=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
o
to
oo
105
TABLE 16 Summary of Organ Weight Data
Week. 14 Sacrifice
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Covance 6329-225 3M T-6314.1
PAGE: 16
TABLE INCLUDES: S E X=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
COOSOl
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: S E X = A L L ; G R O U P = A L L ;W E E K S = A L L DEATH=T ;SUBSET=ALL
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
15 505.3
35.7
15 0.0255 0.0063
M2
NUMBER IN GROUP MEAN
STANDARD DEV
15 482.1
27.7
15 0.0254 0.0078
M3
NUMBER IN GROUP MEAN
STANDARD DEV
15 460.1*
31.8
15 0.0244 0.0048
THYROID/PARATHYR
ORGAN-TOBODY WT (%)
15 0.0051 0.0013
ORGAN-TOBRAIN WT
RATIO
15 0.0117 0.0029
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
15 0.0053 0.0017
15 0.0118 0.0034
F2
NUMBER IN GROUP MEAN
STANDARD DEV
15 0.0053 0.0010
15 0.0112 0.0019
F3
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
ORGAN WEIGHT
<g)
15 270.5
33.3
15 0.0203 0.0062
14 251.3
24.0
14 0.0180 0.0066
15 253.4
17.8
15 0.0190 0.0046
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
15 0.0075 0.0024
15 0.0104 0.0029
14 0.0072 0.0027
14 0.0092 0.0034
15 0.0075 0.0019
15 0.0094 0.0024
o O tO
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
THYROID/ PARATHYR
SEX DOSE GROUP
M4
TERMINAL BODY WT
<g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
15 445.8*
24.4
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
r> o o u
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
ORGAN AND KEYWORD(S) OR PHRASE
** TOP OF LIST ** GENERAL COMMENT (GC) ....................
BONE MARROW SMEAR TAKEN MALOCCLUSION NO MACROSCOPIC LESIONS TAIL - BENT/MISSING STAINS-PERINEUM/PERIANAL
LIVER (LI) ..............................
LIGHT FOCUS(I)/AREA(S) LARGE DIFFUSELY DARK
KIDNEY (KD) .............................
LARGE PELVIS(ES) GRANULAR MATERIAL
SPLEEN (SP) .............................
ADHESION(S)
-- N U M B E R - O F - A N I M A L S - A SEX: ------- MALE------ ----- FEMALE
to 1
1 to
GROUP: -1NUMBER: 2 0
-3- -4- -1-
20 20 20
-3- -4-
20 20
F F E C T E D --
11
1O 1
11 tOo
11 to
20 20 20 20 20 20 20 20
15 15 15 15 15 14 15 15 142 2 0 11 0 8 7 7 6 13 9 11 8 00000001 0 0 10 0 0 0 0
20 20 20 20 20 20 20 20
NOT REMARKABLE: 2 0 2 0 2 0 16 2 0 2 0 2 0 19
0 0 0 10 0 0 0 0 0 0 30 0 0 0 0 0 0 20 0 0 1
20 20 20 20 20 20 20 20
NOT REMARKABLE: 19 19 2 0 18 2 0 2 0 2 0 2 0
11020000 01000000
20 20 20 20 20 20 20 20
NOT REMARKABLE: 2 0 2 0 2 0 2 0 19 2 0 2 0 2 0
00001000
*0304
109
0 6 ^ ;^
ti 1 1 1 11 1 111 11 1 1 1 1 1 11 ! t 1 1 1 11 1 1111 1 tll1 1 111 1 1 11 1 11 !
TABLE 17 Incidence of Macroscopic Observations
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 2
TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS-ALL DEATH=ALL;SUBSET=ALL
-- N U M B E R -O F -A N IMA L S
SEX:
--- MALE-- --
-- -- FEMALE--
GROUP: -1- -2- -3- -4- -1- -2- -3- -4-
ORGAN AND KEYWORD(S) OR PHRASE
NUMBER: 20 20 20 20 20 20 20 20
--
-=- "="
-=" -=- -=- -=-
THYMUS (TH) ................................... .
20 20 20 20 20 20 20 20 NOT REMARKABLE: 17 18 16 18 20 19 19 20
RED FOCUS(I)/AREA(S) DIFFUSELY RED MOTTLED
21310010 01110100 10000000
PITUITARY (PI) ................................ .... NUMBER EXAMINED: 20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 20 20 20 19 20 20 20
LARGE
00001000
STOMACH, GL (ST) ..............................
20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 18 20 18 20 20 19 17
DARK FOCUS (I)/AREA (S) LIGHT FOCUS(I)/AREA(S)
0102 000 3 01 00 001 0
LN, MANDIBULAR (MN) ............................ .... NUMBER EXAMINED: 20 20 20 20 20 20 20 20 NOT REMARKABLE: 16 18 15 16 20 20 17 20
DIFFUSELY RED MOTTLED
32430020 10110010
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
UTERUS (UT) .............................
LUMEN FILLED WITH FLUID OVARY (OV) .............................
DIFFUSELY RED TAIL (TI) ...............................
LACERATION(S) ** END OF LIST **
-- N U M B E R - 0 F - A N I M A L S SEX: ------ MALE------ ----- FEMALE----GROUP: -1- -2- -3- -4- -1- -2- -3- -4NUMBER: 20 20 20 20 20 20 20 20
F F E C T E D --
0 0 0 0 20 20 20 20 NOT REMARKABLE: 0 0 0 0 19 17 19 19
00001311
0 0 0 0 20 20 20 20 NOT REMARKABLE: 0 0 0 0 20 20 19 18
00000012
20 20 20 20 20 20 20 20 NOT REMARKABLE: 20 20 20 20 20 19 20 20
00000100
C5 O
111
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: 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) ..........................
-- N U M B E R - O F - A N I M A L S - A SEX: ------- MALE------- ------FEMALE GROUP: -1- -2- -3- -4- -1- -2- -3- -4NUMBER: 20 20 20 20 20 20 20 20
F F E C T E D --
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
MARROW, FEMUR (FM) ........................ ......... NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
MARROW, STERNUM (SE) ......................
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
BONE, STERNUM (SB) ........................
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
EYE (EY) .................................
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
BRAIN (BR) ...............................
-- INFILTRATE, LYMPHOHISTIOCYTIC SPINAL CORD (SC) .........................
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
C00307
112
TABLE 18 incidence of Microscopic Observations
Covance 6329-225 3M T - 6 3 1 .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 D EATH=ALL;FIND=ALL;SUBSET=ALL
ORGAN AND FINDING DESCRIPTION
-- N UM B E R -0 F -A N IM A L S
SEX:
--- M A L E -- ---
-- --- FEMALE--
GROUP : -1- -2- -3- -4- -1- -2- -3- -4-
NUMBER: 20 20 20 20 20 20 20 20
F F E C T E D ---
LUNG (LU) .......................................
--HEMORRHAGE --INFILTRATE, MACROPHAGE, ALVEOLAR --INFLAMMATION, SUBACUTE --MINERALIZATION, VASCULAR
TRACHEA (TR) ....................................
15 0 0 15 15 1 0 15 NOT REMARKABLE: 6 0 0 7 12 1 0 12
10000000 4 0051002 10000001 5003 2000
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
ESOPHAGUS (ES) ....................
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
LIVER (LI) ........................ .
15 15 15 15 15 15 15 15 NOT REMARKABLE: 5 0 1 0 5 4 2 0
-- FIBROSIS, CAPSULAR -- HYPERTROPHY, HEPATOCELLULAR, DIFFUSE --HYPERTROPHY, HEPATOCELLULAR, CENTRI LOBULAR --INFILTRATE, LYMPHOHISTIOCYTIC --NECROSIS, COAGULATIVE --NECROSIS, INDIVIDUAL HEPATOCYTE -- PIGMENT, HEPATOCELLULAR -- VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL --VACUOLATION, HEPATOCELLULAR, DIFFUSE ** CONTINUED ON NEXT PAGE **
00101000
00 00 00 01
0 0 14 15 0 0 7 14
10 15 13 10 10 11 12
9
00 03 0010
6956364 5
00 02 000 7
0027 0002
0022 0000
C00S08
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)
-- NUMBER -0F-AN IMA LS
SEX:
--- MALE-- --
-- -- FEMALE--
GROUP: -1- -2- -3- -4- -1- -2- -3- -4-
NUMBER: 20 20 20 20 20 20 20 20
F F E C T E D ---
NUMBER EXAMINED: 15 15 15 15 15 15 15 15 NOT REMARKABLE: 5 0 1 0 5 4 2 0
00102300
NUMBER EXAMINED: 15 1 0 15 15 1 0 15 NOT REMARKABLE: 11 0 0 12 14 1 0 12
20000000 11 02 000 0 00000001 10 011 002 10000000
NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 12 0 0 12 15 1 0 14
30030001
NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
*,
o
f^
o
114
TABLE 18 Incidence of Microscopic Observations
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 4
TABLE INCLUDES: SEX=ALL ;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL
ORGAN AND FINDING DESCRIPTION
SPLEEN (SP) .................................
-- INFLAMMATION, CHRONIC, CAPSULAR THYMUS (TH) ................................
-- HEMORRHAGE -- INVOLUTION
LN, MESENTERIC (MS) ........................
--HEMORRHAGE THYROID (TY) ...............................
--CYST, ULTIMOBRANCHIAL --ECTOPIC THYMUS --INFILTRATE, LYMPHOHISTIOCYTIC --ONE EXAMINED
PARATHYROID (PT) ..........................
o
w
--CYST ** CONTINUED ON NEXT PAGE **
op>
-- N U M B E R - O F - A N I M A L S - A SEX: -------MALE------ ----- FEMALE GROUP: -1- -2- -3- -4- -1- -2- -3- -4NUMBER: 20 20 20 20 20 20 20 20
F F E C T E D --
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 14 1 0 15
00001000
15 2 4 15 15 2 1 15 NOT REMARKABLE: 9 0 0 6 11 1 0 10
62 4 94 11 4 00111102
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 13 15 1 0 15
00 02 0000
15 0 0 15 15 1 0 15 NOT REMARKABLE: 4 0 0 8 6 1 0 9
9007 90 0 6 10000000 10000000 10000001
15 0 0 15 15 1 0 15 NOT REMARKABLE: 13 0 0 15 15 1 0 14
10000000
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
NUMBER -0F -AN IMA LS
SEX:
--- MALE---- -- -- -- FEMALE--
GROUP: -1- -2- -3- --4- -1- -2- -3- -4-
ORGAN AND FINDING DESCRIPTION
NUMBER: 20 20 20 20 20 20 20 20
** FROM PREVIOUS PAGE **
PARATHYROID (PT) ................ ................... NUMBER EXAMINED: 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
00010000
ADRENAL, MEDULLA (MA) ...........
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 --
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
co
CP
15 NOT REMARKABLE: 14
1 0
14 NOT REMARKABLE: 14
0
0 0 15 15 0 0 14 14
0010 0001
2 15 15 15 1 15 13 15
1 02 0
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
<?
o*py
U)
TABLE INCLUDES: S E X = A L L ;G R O U P = A L L ; W E E K S = A L L D EATH=ALL;FIND=ALL;SUBSET=ALL
ORGAN AND FINDING DESCRIPTION
N UM BER -0 F -AN IMA LS
SEX:
--- M A L E ---- --
-- --- FEMALE--
G R O U P : -1- -2- -3- --4- -l- -2- -3- -4-
NUMBER: 20 20 20 20 20 20 20 20
F F E C T E D ---
STOMACH, NONGL (SU) ...............
14 NOT REMARKABLE: 14
0 15 15 15 0 15 15 15
1 15 15 1 15 15
PANCREAS (PA) .....................
--ATROPHY, ACINAR -- INFILTRATE, LYMPHOHISTIOCYTIC -- INFLAMMATION, CHRONIC-ACTIVE -- PIGMENT, BROWN
DUODENUM (DU) .....................
15 0 0 15 15 1 0 15 NOT REMARKABLE: 11 0 0 13 14 1 0 13
0001100 1 2 000 1 002 1 002 000 0 2 002 000 0
14 0 0 15 15 1 0 15 NOT REMARKABLE: 14 0 0 15 15 1 0 15
JEJUNUM (JE) ....................... ...................... NUMBER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
ILEUM (IL) .........................
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
CECUM (CE) .........................
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15
117
TABLE 18 Incidence of Microscopic Observations
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N--MEFOSE, T--6314) IN :RATS
PAGE: 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) ............
f t --ONE EXAMINED
ry
CO yh u
NUM BER -0P -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
F F E C T E D --
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
42 582 0 31 00001000
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
10 02 0001
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 12 11 1 0 13
00034002
118
TABLE 18 Incidence of Microscopic Observations
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T--6314) IN RATS
PAGE: 8
TABLE INCLUDES: S E X = A L L ;G R O U P = A L L ;W E E K S = A L L D E A T H = A L L ;F I N D = A L L ; S U B S E T = A L L
ORGAN AND FINDING DESCRIPTION
SKIN (SK) ..........................
--EXUDATE, EPIDERMAL SURFACE --INFLAMMATION, SUBACUTE MAMMARY, FEMALE (MF) ..............
URINARY BLADDER (UB) .............
--INFILTRATE, LYMPHOHISTIOCYTIC UTERUS (UT) ........................
--DILATATION
r v CERVIX <CV) ........................ 0 i OVARY (OV) ......................... p 1
N U MBER -0 F -AN IMA LS
SEX:
--- M A L E -------
______ -- F E M A L E --
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 ---
15 0 0 15 15 1 0 15 NOT REMARKABLE: 14 0 0 15 15 1 0 15
1 00 0000 0 10000000
0 0 0 0 15 1 0 15 NOT REMARKABLE: 0 0 0 0 15 1 0 15
15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 13 15 1 0 15
0002 0000
0 0 0 0 15 4 1 15 NOT REMARKABLE: 0 0 0 0 14 1 1 10
0000 130 5
0 0 0 0 15 1 0 15 NOT REMARKABLE: 0 0 0 0 15 1 0 15
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
-- N U M B E R - O F - A N I M A L S - A SEX: ------- MALE------- ------FEMALEGROUP: -1- -2- -3- -4- -1- -2- -3- -4NUMBER: 20 20 20 20 20 20 20 20
F F E C T E D --
VAGINA (VA) ............................... ......... NUMBER EXAMINED: 0 0 0 0 15 1 0 15 NOT REMARKABLE: 0 0 0 0 15 1 0 15
PROSTATE (PR) .............................
15 0 0 15 0 0 0 0 NOT REMARKABLE: 3 0 0 9 0 0 0 0
--INFILTRATE, LYMPHOHISTIOCYTIC --INFLAMMATION, CHRONIC-ACTIVE
12 0 0 6 0 0 0 0 00010000
SEMINAL VESICLES (SV) ..................... ......... NUMBER EXAMINED: 15 0 0 15 0 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 0
TESTIS (TE) ..............................
15 0 0 15 0 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 0
EPIDIDYMIDES (EP) .........................
15 0 0 15 0 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 0
TAIL (TI) ................................
--HEMORRHAGE --ULCERATION ** END OF LIST **
-''s 0
00000100 NOT REMARKABLE: 0 0 0 0 0 0 0 0
00000100 00000100
01 120
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: S E X =ALL;GROUP=ALL;WEEKS=ALL D EATH=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 **
6
03
-- N U M BE R -OF -A N IMA LS SEX: GROUP: -l- -2- -3- -4- - i - -2- -3- -4NUMBER: 20 20 20 20 20 20 20 20
15 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 2> 0 TL> 15 MN> 0.0
15 0
15 0.0
15 0
15 0.0
15 0
15 0.0
15 0
15 0.0
15 0
15 0.0
15 0
15 0.0
14 1
15 0.1
->
i>
2> 3> TL> MN>
15 0 0 0
15 0.0
15 0 0 0
15 0.0
1 11
3 0 15 1.1
0 0 1 14 15 2.9
15 0 0 0
15 0.0
15 0 0 0
15 0.0
8 7 0 0 15 0.5
1 0 7 7 15 2.3
-> 5 1> 10 2> 0
15 0.7
0 14
1 15 1.1
2 13
0 15 0.9
5 10
0 15 0.7
5 10
0 15 0.7
4 11
0 15 0.7
3 12
0 15 0.8
6
9 0 15 0.6
AA
3
F F E C T E D ---
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 : -1- -2- -3- -4- -1- -2- -3- -4-
ORGAN/TISSUE EXAMINED
NUMBER: 20 20 20 20 20 20 20 20
** FROM PREVIOUS PAGE **
LIVER (LI) ......................................... 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 1> 6 9 5 5 3 6 4 5 2> 0 0 0 1 0 0 0 0
TL> 15 15 15 15 15 15 15 15 MN> 0.4 0.6 0.3 0.5 0.2 0.4 0.3 0.3
--PIGMENT, HEPATOCELLULAR
-> 15 15 15 13 15 15 15 8 i> 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 1> 0 0 2 5 0 0 0 2 2> 0 0 0 2 0 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.6 0.0 0.0 0.0 0.1
F F E C T E D --
<>
o
C
-a
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
ORGAN/TISSUE EXAMINED ** FROM PREVIOUS PAGE ** LIVER (LI) .....................
--VACUOLATION, HEPATOCELLULAR, DIFFUSE
--VACUOLATION, HEPATOCELLULAR, PERIPORTAL
STOMACH, GL (ST) ............... --EROSION
** END OF LIST **
-- N UM BER -0F -AN IMA LS
SEX:
--- MALE- -- --
-- -- -FEMALE--
GROUP: -1- -2- -3- -4- -1- -2- -3- -4-
NUMBER: 20 20 20 20 20 20 20 20
F F E C T E D --
EXAMINED: 15 15 15 15 15 15 15 15 "> 15 15 13 13 15 15 15 15 1> 0 0 2 0 0 0 0 0 2> 0 0 0 2 0 0 0 0
TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.3 0.0 0.0 0.0 0.0
-> 15 15 14 15 13 12 15 15 1> 0 0 1 0 2 3 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.0 0.1 0.2 0.0 0.0
EXAMINED: 14 2 15 15 15 1 15 15 "> 14 1 15 13 15 1 15 12 1> 0 0 0 1 0 0 0 2 2> 0 1 0 1 0 0 0 1
TL> 14 2 15 15 15 1 15 15 MN> 0.0 1.0 0.0 0.2 0.0 0.0 0.0 0.3
'S
o Ci5
123
APPENDIX 1
Protocol Deviations Protocol
Protocol Amendment No. 1 Protocol Amendment No. 2 Protocol Amendment No. 3
Covane* 6329-225 3M T-6314.1
124 0 0 3 1 9
Protocol Deviations
Covance 6329-225 3M T-6314.1
Protocol. Housing. Diet. "Certified Rodent Diet #5002, meal (PMI Nutrition International) ad libitum, unless otherwise specified."
A ctual Procedure. The animals were given Teklad 8728C pelleted food from August 17, 1998 to August 23, 1998.
Protocol. Dose Preparation. Retention Samples. "During the in-life phase, samples (approximately 100 g) will be taken from each dose preparation sampled for dose analyses and stored at room temperature. Unless used for analyses, these samples will be discarded approximately 1 month after completion o f the in-life phase."
A ctual Procedure. Retention samples were discarded after approximately 1 month o f the completion o f the in-life phase.
Protocol. Observation o f Animals. Clinical Observations. "Each animal will be observed twice daily (a.m. and p.m.) for mortality and moribundity, recording findings as they are observed."
A ctual P rocedure. 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 o f treatment, five animals/sex/group will be fasted overnight, bled for serum samples, anesthetized with carbon dioxide, weighed, and exsanguinated."
A ctual Procedure. Fasting o f animals at the Week 5 scheduled sacrifice was not documented.
C 'iQ 3 2 Q
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 P rocedure. 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
126
C O V IC >
THE DEVELOPMENT SERVICES COMPANY
Sponsor:
3M St. Paul, Minnesota
PROTOCOL
Study Title:
13-W eek Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE, T-6314) in Rats
Date: August 27, 1998
Performing Laboratory: Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595
Laboratory Study Identification: Proposal No. 90545D Covance 6329-225
Sponsor Project Identification: 3M T-6314.1
127
C 003Z2
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 Monitor Andrew M. Seacat, PhD 3M Toxicology Services Telephone No.: 651.575.3161 Facsimile No.: 651.733.1773
Alternate Study Monitor 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 o f Federal Regulations, Part 58, issued December 22, 1978 (effective June 20, 1979), and with any applicable amendments.
Animal Care and Use Statement All procedures in this protocol are in compliance with the Animal Welfare Act Regulations, 9 CFR 1-4. In the opinion 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.
c-0 0 3 2 4
129
Test M aterial
Covance 6329-225 __________ Page 4
Identification N-Methyl Perfluorooctanesulfonainido 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 aracteristics Information on synthesis methods, composition, or other characteristics that define the test material is on file with the Sponsor.
Reserve (Archive) Samples A reserve sample (approximately 5 g) o f each lot will be taken and stored at room temperature. These samples will be transferred to the Sponsor after completion o f the in-life phase.
Disposition of Test M aterial After authorization from the Sponsor, any remaining test material will be returned to:
Andrew M. Seacat, PhD 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Telephone No.: 651.575.3161 Facsimile No.: 651.733.1773
.f\Q 3 'Z 5
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
Weight at Initiation of Treatment 100 to 300 g
Number and Sex 80 males and 80 females
Identification Implantable microchip identification device
Husbandry
Housing Individual (may be group-housed during acclimation). Animals will be housed in suspended, stainless steel cages.
Diet Certified Rodent Diet #5002, meal (PMI Nutrition International) ad libitum, unless otherwise specified. The diet is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Specified nutrient and contaminant analyses are on file at Covance-Madison.
C-G032S
131
Covance 6329-225 ___ ______ Page 6
Water Ad libitum. Samples o f the water are routinely analyzed for specified microorganisms and environmental contaminants. The results are on file at Covance-Madison.
Contaminants There are no known contaminants in the diet or water at levels that might interfere with this study.
Environment Environmental controls for the animal room will be set to maintain 18 to 26C, a relative humidity of 30 to 70%, and a 12-hour light/12-hour dark cycle. The light/dark cycle may be interrupted to accommodate in-life procedures.
Acclimation At least 1 week
Randomization Selection o f animals for the study will be based on clinical observations, ophthalmic examinations, and other data as appropriate. Animals will be assigned to treatment groups using a computerized blocking procedure designed to achieve body weight balance with respect to treatment groups. At the time of randomization, the weight variation o f the animals of 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.
c 10327
132
Group Designations and Dietary Levels
Covance 6329-225 __________ Page 7
Number o f Animals
Dietary Levels
Group
Male
Female
(ppm MeFOS)a
1 (Control)"
20
20
0
2 (Low) 20 20
3
3 (Mid) 20 20
30
.4 (High)_______
20
20
100
a Dose levels are expressed as ppm o f MeFOS.
b The control animals will receive the basal diet only.
Dosing Procedures
Method of Administration Dietary, 7 days/week for at least 13 weeks. Treatment will continue through the day before necropsy.
Reason for Dosing Route The potential route o f exposure in humans is oral.
Dose Preparation All dose preparations will be mixed according to the study-specific mixing procedure developed by Covance. Dose concentrations will be based on the MeFOS content as supplied. All dose preparations will be stored at room temperature.
Before initiation of treatment, dose preparations o f 1 ppm, 3 ppm, 30 ppm, 100 ppm and 500 ppm will be mixed.
Dose preparations will be mixed at least once every 4 weeks during the in-life phase.
Retention Samples During the in-life phase, samples (approximately 100 g) will be taken from each dose preparation sampled for dose analyses and stored at room temperature. Unless used for analyses, these samples will be discarded approximately 1 month after completion o f the in-life phase.
C00328
133
Covance 6329-225 __________ Page 8
Dose Analyses By Covance, using a method supplied by the Sponsor and validated by Covance
H om ogeneity 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 of 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
Covance 6329-225 ___________________________________________________ ___________________________________ Page 9
Observation of Animals
Clinical Observations Each animal will be observed twice daily (a.mu 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 treatm ent 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 W eeks 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).
-00930
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Covance 6329-225 _________ Page 10
Tests
Hematology
red blood cell (erythrocyte) count hemoglobin hematocrit mean corpuscular volume mean corpuscular hemoglobin mean corpuscular hemoglobin concentration
platelet count white blood cell (leukocyte) count differential blood cell count blood cell morphology reticulocyte smear (made, but not
examined)
Clinical Chemistry
glucose urea nitrogen creatinine total protein albumin globulin cholesterol triglycerides total bilirubin
alanine aminotransferase gamma glutamyltransferase aspartate aminotransferase calcium inorganic phosphorus sodium potassium chloride
Urinalysis
appearance volume specific gravity pH protein urobilinogen
glucose ketones bilirubin blood microscopic examination o f sediment
Serum Perfluorooctane Sulfonic Acid (PFOS) Analyses
Frequency and Number of Animals Five animals/sex/group after at least 4 and 13 weeks of treatment. Samples after 4 weeks of treatment will be collected from animals selected for the interim sacrifice.
{ 00321-
136
Covance 6329-225 _________ Page 11
Method of Collection Animals will be fasted overnight; blood (approximately 4 mL) will be collected from a jugular vein. Samples will be collected without anticoagulant.
Sample Handling Blood samples will be allowed to clot at room temperature and centrifuged. Serum samples will be harvested and stored in a freezer set to maintain -60 to -80C. Samples will be packed on dry ice and shipped to:
Kris J. Hansen, PhD 3M Environmental Technology and Safety Services 935 Bush Avenue Building 2-3E-09 St. Paul, Minnesota 55133-3331 Telephone N o.: 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.
Termination
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.
00332
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Covance 6329-225 _________ Page 12
After at least 13 weeks o f treatment, all surviving animals will be fasted overnight, bled for serum samples (five animals/sex/group) and clinical pathology tests (10/sex/group), anesthetized with carbon dioxide, weighed, exsanguinated, and necropsied. Liver samples will be collected for palimitoyl CoA, PCNA, and PFOS analysis.
Postmortem Procedures
Necropsy The necropsy will include an examination o f the external features o f the carcass; all external body orifices; the abdominal, thoracic, and cranial cavities; organs; and tissues.
O rgan 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 of treatment only; made but not examined
Cell Proliferation Tissue Collection and Immunohistochemical Evaluation A t the scheduled sacrifice after 13 weeks o f 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.
Pahnitoyl-CoA Oxidase Tissue Collection and Analyses At the scheduled sacrifices, the right lateral lobe o f the liver will be collected from each animal and flash-frozen in liquid nitrogen. The liver tissue will be stored in a freezer set to maintain -60 to -80 C until analyzed by Covance for palmitoyl-CoA oxidase activity.
Liver PFOS Analysis At scheduled sacrifices, the remaining portion of the liver from each animal after other required collections will be stored in a freezer set to maintain -60 to -80C. Samples will be packed on dry ice and shipped to Kris J. Hansen, PhD, 3M Environmental Technology and Safety Services. Liver samples will be analyzed for PFOS and metabolites by the Sponsor. Results will be reported separately by the Sponsor.
Tissue Preservation The following tissues (when present) from each animal that is found dead, sacrificed at an unscheduled interval, or sacrificed at the scheduled sacrifice after 13 weeks o f treatment will be preserved inl0% neutral-buffered formalin:
C00934
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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 of the distal end) Harderian gland heart ileum with Peyer's patch (lymphoid
aggregate) jejunum kidney (2) lesions liver lung with mainstem bronchi lymph nodes (mesenteric and mandibular) mammary glands (females only)
ovary (2) pancreas pituitary prostate rectum salivary gland [mandibular (2)] sciatic nerve seminal vesicle (2) skeletal muscle (thigh) skin spinal cord (cervical, mid-thoracic, and
lumbar) spleen sternum with bone marrow stomach testis (2) thymus thyroid (2) with parathyroid trachea urinary bladder uterus vagina Zymbal's gland
Histopathology Tissues (as appropriate) from each animal in the control and high-dose groups and each animal that dies o r 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:
C-00935
140
Experimental Design and Methods
Covance 6329-225 _________ Page 15
Results dose analyses mortality clinical observations body weights body weight changes food consumption test material consumption ophthalmic findings clinical pathology results palmitoyl CoA oxidase activities macroscopic observations microscopic observations cell proliferation assessments (provided by the Sponsor's designee)
Statistical Evaluation Levene's test will be done to test for variance homogeneity. In the case of 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 W eek 1, one-way analysis o f covariance (ANCOVA) will be used to analyze body weights, with initial body weights as the covariate. If the ANCOVA is significant, covariate-adjusted means will be used for control versus treated group comparisons.
Group comparisons (Groups 2 through 4 versus Group 1) will be evaluated at the 5.0%, two-tailed probability level. Only data collected on or after the first day of treatment will be analyzed statistically.
C00936
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 of this study will be archived in the storage facilities of Covance-Madison for a period o f 1 year following submission o f the final report to the Sponsor. One year after submission of the final report, the aforementioned materials will be sent to the Sponsor, and a return fee will be charged; all raw data stored on magnetic media, protocol, study correspondence, and the original final report will be retained by Covance. The Sponsor may elect to have the materials retained in the Covance archives for an additional period o f time, and Covance will charge a storage fee. If the Sponsor chooses to have Covance dispose o f the materials, a disposal fee will be charged.
PCNA antigen evaluation data will be retained by Pathology Associates International. Liver and serum samples sent to the Sponsor and analysis data will be retained by the Sponsor.
C00937
142
PROTOCOL APPROVAL
Covance 6329-225 _________ Page 17
t'iosas
143
C O V /H TS^
THE DEVELOPMENT SERVICES COMMNV
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 O ctober 1,1998
2. Page 12, Postm ortem Procedures, Ceil 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.
CM0939
144
Covance 6329-225
Protocol Amendment No. 1
____________
Page 2
AMENDMENT APPROVAL
..... Andrew M. Seacat, PhD Study Monitor 3M
Date Date
C-'!03-i0
145
covaicT '
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 rep aratio 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.
I'll
146
Covance 6329-225 Protocol Amendment No. 2 __________________ Page 2
Effective December 4,1998
2. Page 13, Postmortem Procedures, Liver PFOS 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 o f the liver from each animal after other required collections will be flash-frozen in liquid nitrogen and stored in a freezer set to maintain -60 to -80C.
Effective December 15,1998
3. Page 13, Postmortem Procedures, Cell Proliferation Tissue Collection and Immunohistochemical Evaluation, Paragraph 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, Postmortem Procedures, Histopathology, Paragraph 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.
c 42
147
Covance 6329-225 Protocol Amendment No.2 _________________ Page 3
Effective February 8,1999
5. Page 14, P ostm ortem Procedures, H istopathology, P a ra g ra p h 3. Liver and was identified as target organ in animals in the mid-dose group and will be examined in animals from the low-dose group. Therefore delete this paragraph and replace with the following:
Liver and stomach from each animal in the mid-dose group and liver from each animal in the low-dose group will be embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically.
AMENDMENT APPROVAL
Andrew M. Seacat, PhD Study Monitor 3M
Study Dirrtor
//
Covance Laboratories Inc.
C 0 0 9 'i3 148
cov/h T '
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
00944
149
Covance 6329-225
3Protocol Amendment N o .4 --
__________________ Page 2
Storage Conditions At room temperature
Characteristics Information on synthesis methods, composition, or other characteristics that define the vehicle is on file with the manufacturer.
AMENDMENT APPROVAL
Andrew M. Seacat, PhD Study Monitor 3M
to * if f ? Dati
5^ ^
%
Q%
^
150
APPENDIX 2
Individuai Animai Fate Data Individuai Clinical Observations Individual Ophthalmic Observations
Covane* 6329-225 3M T-6314.1
to c a o s
151
/*i
G C5
APPENDIX 2 Individual Animal Fate Data
Covance 6329-225 3M T-6314.1
13-WEEK d i e t a r y t o x i c i t y s t u d y w i t h n -m e t h y l PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 1
ANIMAL DOSE NUMBER GROUP
C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95911 C95912 C95913 C95914 C95915 C95916 C95917 C95918 C95919 C95920 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95931 C95932 C95933 C95934
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
1 1
11 2 2
2 2 2 2 2 2 2 2 2 2 2 2
SEX
MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE MALE
DEATH CODE
T T T T T T T T T T 1 1 1 1 1 T T T T T T T T T T T T T T T i i i i
TYPE OF DEATH
SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED
DESCRIPTION OF DEATH
TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE
DATE OF DEATH
DAY OF 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
SEX
DEATH CODE
TYPE OF DEATH
DESCRIPTION OF DEATH
DATE OF DEATH
DAY OF STUDY
WEEK STU]
C95935
2
MALE
1 SCHEDULED FIRST INTERIM SACRIFICE 10/01/98 31
5
C95936
2
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95937
2
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95938
2
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95939
2
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95940
2
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95941
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95942
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95943
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95944
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95945
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95946
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95947
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95948
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95949
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95950
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95951
3
MALE
1 SCHEDULED FIRST INTERIM SACRIFICE 10/01/98 31
5
C95952
3
MALE
1 SCHEDULED FIRST INTERIM SACRIFICE 10/01/98 31
5
C95953
3
MALE
1 SCHEDULED FIRST INTERIM SACRIFICE 10/01/98 31
5
C95954
3
MALE
1 SCHEDULED FIRST INTERIM SACRIFICE
10/01/98
31
5
C95955
3
MALE
1 SCHEDULED FIRST INTERIM SACRIFICE 10/01/98 31
5
C95956
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95957
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95958
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95959
3
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
o 4C95960 C95961
3
MALE MALE
T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE
12/02/98 12/02/98
93 93
14 14
C95962
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95963
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95964
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
03
C95965 C95966
4 4
MALE MALE
T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE
12/02/98 12/02/98
93 93
14 14
C95967
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
14
C95968
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
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
DEATH CODE
TYPE OF DEATH
DESCRIPTION OF DEATH
DATE OF DAY OF WEEK OF
DEATH
STUDY
STUDY
C95969
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95970
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95971
4
MALE
i SCHEDULED FIRST INTERIM SACRIFICE
10/01/98
31
C 95972
4
MALE
i SCHEDULED FIRST INTERIM SACRIFICE 10/01/98 31
C95973
4
MALE
i SCHEDULED FIRST INTERIM SACRIFICE 10/01/98 31
C95974
4
MALE
i SCHEDULED FIRST INTERIM SACRIFICE
10/01/98
31
C95975
4
MALE
i SCHEDULED FIRST INTERIM SACRIFICE
10/01/98
31
C95976
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95977
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95978
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95979
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95980
4
MALE
T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95981
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95982
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95983
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95984
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95985
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95986
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95987
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95988
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95989
1 FEMALE
T
SCHEDULED Te r m i n a l s a c r i f i c e
12/02/98
93
C95990
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95991
1 FEMALE
1
SCHEDULED FIRST INTERIM SACRIFICE
10/01/98
31
C95992
1 FEMALE
1
SCHEDULED FIRST INTERIM SACRIFICE
10/01/98
31
C95993
1 FEMALE
1
SCHEDULED FIRST INTERIM SACRIFICE
10/01/98
31
C95994 1 FEMALE
1 SCHEDULED FIRST INTERIM SACRIFICE
10/01/98
31
C95995 1 FEMALE 1 SCHEDULED FIRST INTERIM SACRIFICE 10/01/98 31
C95996
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95997
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95998 1 FEMALE T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C95999
1 FEMALE
T
SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C96000 1 FEMALE T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C96001 2 FEMALE T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
C96002 2 FEMALE T SCHEDULED TERMINAL SACRIFICE
12/02/98
93
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
cs
6000
154
Zl' O
CD
Ui
o
APPENDIX 2 individual Animal Fate Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 4
ANIMAL DOSE NUMBER GROUP
SEX
C96003
2 FEMALE
C96004
2 FEMALE
C96005
2 FEMALE
C96006
2 FEMALE
C96007
2 FEMALE
C96008 2 FEMALE
C96009
2 FEMALE
C96010 2 FEMALE
C96011
2 FEMALE
C96012 2 FEMALE
C96013
2 FEMALE
C96014
2 FEMALE
C96015
2 FEMALE
C96016 2 FEMALE
C96017
2 FEMALE
C96018 2 FEMALE
C96019 2 FEMALE
C96020
2 FEMALE
C96021
3 FEMALE
C96022
3 FEMALE
C96023
3 FEMALE
C96024 3 FEMALE
C96025
3 FEMALE
C96026
3 FEMALE
C96027
3 FEMALE
C96028
3 FEMALE
C96029
3 FEMALE
C96030
3 FEMALE
C96031
3 FEMALE
C96032
3 FEMALE
C96033
3 FEMALE
C96034
3 FEMALE
C96035
3 FEMALE
C96036
3 FEMALE
DEATH CODE
TYPE OF DEATH
DESCRIPTION OF DEATH
T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE T SCHEDULED TERMINAL SACRIFICE 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 DEATH
DAY OF 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 C96038 C96039 C96040 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96051 C96052 C96053 C96054 C96055 C96056 C96057 C96058 C96059 C96060
3 FEMALE 3 FEMALE 3 FEMALE 3 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE 4 FEMALE
DEATH CODE
T T T T T T T T T T T T T T i i i i i 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 DEATH
DAY OF 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
ft
O Q (A
156
Appendix 2 Individual Clinical Observations
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Covance 6329-225 3M T-6314.1
PAGE: 1
CATEGORY
ANIMAL DEATH WK OF
KEYWORD
NUMBER CODE DEATH
QUALIFIER
GROUP: Ml
DOSE: 0 PPM
DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C' - COMMENTS LISTED A T END OF OBSERVATIONS
C95901 C95902 C95903
T T T
C95904 T
trs C95905 T
o C95906 T C95907 T
Cl C95908 T N C95909 T
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 APPEARANCE MALOCCLUSION
SKIN & PELAGE BLACK SKIN TAIL-DISTAL
14 DISCHARGE GENITAL RED IN COLOR
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 APPEARANCE MALOCCLUSION
29, 36 50, 57, 64, 71 92
71, 78, 85, 92-93
157
Appendix 2 Individual Clinical Observations
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Covance 6329-225 3M T-6314.1
PAGE: 2
CATEGORY
ANIMAL DEATH WK OF
KEYWORD
NUMBER CODE DEATH
QUALIFIER
GROUP: Ml
DOSE: 0 PPM
DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C' - COMMENTS LISTED AT END OF OBSERVATIONS
C95910 C95911 C95912 C95913
T i i i
C95914 C95915 C95916 C95917 C95918 C95919 C95920
i i 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
22, 29, 31
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
C95921 T
C95922 C95923 C95924 C95925
T T T T
C95926 C95927 C95928 C95929 C95930
T T T T T
C95931 i
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
PPM
DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; C' - COMMENTS LISTED A T END O F OBSERVATIONS
22, 29
71, 78, 85, 92-93 71
64, 71, 78
'>
o
C/T
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
1 1 1 1
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
S 0 i/3
(A
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
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 i i i i i 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
C0095'
4 162
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 A T END OF OBSERVATIONS
C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968
T T T T T T T T
iT>
O
ca
a
,,*
V l
00
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
GOi/O
U
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 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; 'C` - COMMENTS LISTED AT END OF OBSERVATIONS
C95981 T
C95982 C95983 C95984 C95985 C95986
T T T T T
C95987 C95988 C95989 C95990
T T T T
14 APPEARANCE LIMITED USE LIMB-HIND--LEFT SWOLLEN LIMB-HIND--LEFT
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 APPEARANCE MALOCCLUSION
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
14 ANIMAL HAS NO SIGNIFICANT FINDINGS
o
03
oo
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
i i i i i T T T T T
5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS
(T>
O w o p
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 A T 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
O 0?
w
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
C96D19 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 N O SIGNIFICANT FINDINGS
22, 29
59 78, 85, 92-93 15
vW o o Q
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
o
w
O
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
ANIMAL DEATH WK OF NUMBER CODE DEATH
CATEGORY KEYWORD QUALIFIER
GROUP: F3
DOSE: 30 PPM DAYS 1-93
OBSERVED DURING THE DAYS LISTED BELOW; C* - COMMENTS LISTED A T END OF OBSERVATIONS
C96030 C96031 C96032 C96033 C96034 C96035 C96036 C96037 C96038 C96039 C96040
T i i i i i 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
600^
o cn
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; C' - COMMENTS LISTED A T 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
e
(7 )
m
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
ANIMAL DEATH WK OF NUMBER CODE DEATH
CATEGORY KEYWORD 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 C96058 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
r> -> O w o
172
ANIMAL NUMBER
C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95916 C95917
r s C95918
oo
Q O 03
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
173
Covance 6329-225 3M T-6314.1
PAGE: 1
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
s
c
U3 (;'> C2
174
ANIMAL NUMBER
C95921 C95922 C95923 C95924 C95925
C95926 C95927 C95928 C95929 C95930 C95936 C95937
o
e
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
175
Covance 6329-225 3M T-6314.1
PAGE: 3
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
o
176
ANIMAL NUMBER
C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95956
o C95957
CD
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 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 3M T-6314.1
PAGE: 6
GOi/3
aT u
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
Covance 6329-225 3M T-6314.1
PAGE: 7
f'vSOO )
179
ANIMAL NUMBER
C95978 C95979 C95980
Appendix 2
Individual Ophthalmic Observations Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL
PER FLU O RO O C TAN ESU LFO N AM ID O ETH AN O L (N -M E F O S E , 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
rs
O CD
w 180
ANIMAL NUMBER
C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95996 C95997 C95998
03 m
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
181
Covance 6329-225 3M T-6314.1
PAGE: 9
ANIMAL NUMBER
C95999 C96000
Appendix 2
Individual Ophthalmic Observations Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
CATEGORY KEYWORD QUALIFIER
GROUP: 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
r
O Q 3
182
ANIMAL NUMBER
C96001 C96002 C96003
C9600i
C96005 C96006 C96007 C96008 C96009 C96010 C96016 C96017 C96018
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 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS
Covance 6329-225 3M T-6314.1
PAGE: 11
s^eoi/}
183
ANIMAL NUMBER
C96019 C96020
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
Vt-,' o CD ` .I Q
184
ANIMAL NUMBER
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96036 C96037 C96038
Appendix 2
Individual Ophthalmic Observations Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
CATEGORY KEYWORD QUALIFIER
GROUP: F3
DOSE: 30 PPM WEEK 14
ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS
Covance 6329-225 3M T-6314.1
PAGE: 13
OSbQQQ
185
ANIMAL NUMBER
C96039 C96040
Appendix 2
Individual Ophthalmic Observations Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
CATEGORY KEYWORD QUALIFIER
GROUP: F3
DOSE: 30 PPM WEE K 14
ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS
Covance 6329-225 3M T-6314.1
PAGE: 14
^
o
CD 0 P
186
ANIMAL NUMBER
C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96057 C96058
n
oO
Gd
Appendix 2
Individual Ophthalmic Observations Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
CATEGORY KEYWORD QUALIFIER
GROUP: F4
DOSE: 100 PPM WEEK 14
ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS
187
Covance 6329-225 3M T-6314.1
PAGE! 15
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
CS60G0
188
APPENDIX 3 Individual Body W eight D ata (g)
Covane* 6329-225 3M T-6314.1
C009S4
189
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 1
WEEK 2
GROUP: MALE 1 - 0 PPM
C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95911 C95912 C95913 C95914 C95915 C95916 C95917 C95918 C95919 C95920
208 216 204 206 204 197 208 202 203 215 225 222 234 202 185 226 205 209 213 216
261 271 254 259 257 250 253 262 254 272 273 281 299 256 219 284 264 262 270 267
GROUP: MALE 2 - 3 PPM
C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928
215 207 201 232 227 206 202 199
267 256 253 281 282 250 251 257
WEEK 3
WEEK 4
WEEK 5
WEEK 67
WEEK 8
WEEK 9
314 352 380 391 420 430 321 362 392 407 433 444 308 355 374 398 424 437 315 361 395 409 436 453 303 341 376 386 411 433 304 355 391 411 445 461 298 342 366 383 406 417 316 364 399 417 442 461 288 319 352 359 384 395 326 377 415 429 457 477 304 337 361 334 389 411 345 353 402 302 349 377 245 276 293 342 389 425 462 487 506 324 370 400 428 454 474 321 371 395 418 438 458 326 370 405 427 452 465 317 360 397 422 443 464
312 350 372 389 411 422 301 345 374 389 413 421 306 346 374 390 418 437 327 360 388 406 427 445 334 376 402 418 439 461 294 324 350 366 380 401 299 336 359 373 397 417 314 359 391 404 429 447
Covance 6329-225 3M T-6314.1
PAGE: 1
WEEK
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
C00985
190
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 1
WEEK 2
GROUP: MALE 2 - 3 PPM
C95929 C95930 C95931 C95932 C95933 C95934 C95935 C95936 C95937 C95938 C95939 C95940
208 220 210 203 206 191 208 224 217 221 209 214
259 275 258 252 260 238 261 290 273 283 255 263
GROUP: MALE 3 - 30 PPM
C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956
199 203 230 209 205 204 202 216 219 215 236 205 207 225 198 209
245 248 283 263 261 253 252 265 276 268 297 250 258 279 259 264
cc
WEEK 3
WEEK 4
WEEK 5
WEEK 67
WEEK 8
WEEK 9
311 329 316 303 308 283 318 355 321 335 299 311
284 294 331 307 315 294 299 316 332 323 351 294 308 332 314 318
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
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
393 413
465 395 426 384 398
357 360 408 382 395 386 381 397 428 407
425
418 441
496 412 451 404 418
373 380 429 404 418 410 397 419 457 431
448
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
WEEK 10
461 475 472 477
528 554 444 459 486 505 433 44 2 455 470
403 407 400 408 466 486 430 438 462 477 450 464 433 451 457 467 502 513 463 465
489 505
191
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL . PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 1
WEEK 2
GROUP : MALE 3 - 30 PPM
95957 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
WEEK 7
427 406 392 420
442 381 412 418 371 386 399 422 417 427
361 400 410 398 397
WEEK 8
440 420 401 426
456 397 427 434 382 405 408 437 432 434
367 416 422 407 409
Covance 6329-225 3M T-6314.1
PAGE: 3
WEEK 9
WEEK 10
460 438 421 446
476 412 452 447 393 426 423 417 451 453
474 459 436 452
489 423 463 456 411 438 438 448 463 447
380 388 432 448 439 449 419 429 429 437
o to CO o
192
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 1
WEEK 2
GROUP: 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
ow
143 142 153 176 165 150 164 168
161 160 168 153 187 170 188 186
00 03
WEEK 3
220 213 186 215 213 218 182 182 204 225 214 177 184 217 181 210 192 202 222 206
187 176 190 124 205 187 202 217
WEEK 4
240 216 195 241 234 230 213 215 228 256 219 203 207 229 201 237 211 226 260 225
204 178 201 198 221 210 226 229
WEEK 5
256 224 214 247 240 236 211 217 249 280 240 213 218 245 207 244 219 237 286 232
201 200 196 218 224 218 234 238
WEEK 6
260 234 211 243 254 247 218 232 252 279
258 223 241 300 248
214 205 207 236 232 220 245 246
WEEK 7
273 241 224 251 262 260 220 239 254 292
260 233 241 318 261
224 209 217 243 236 232 244 261
WEEK 8
287 246 219 254 267 262 229 234 262 301
264 238 246 318 261
228 209 215 239 241 234 250 260
193
Covance 6329-225 3M T-6314.1
PAGE: 4
WEEK 9
WEEK 10
286 256 229 263 270 262 240 250 286 302
288 261 231 276 286 273 250 251 283 322
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
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK i
WEEK 2
GROUP: 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
284 295 296 283 281 289 288 252 256
242 249 271 275 255 264 269 273 251 265 232 233 ' 297 300 266 269
245 2 51
251 251
261 266
C003S
194
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 1
WEEK 2
GROUP: FEMALE 3 - 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
WEEK 4
WEEK 5
WEEK 67
WEEK 8
WEEK 9
202 203 201 170
180 200 188 217 207 211 185 199 163 187 185 208 176 180 172 190 218 224 176 213
226 221 225 188
194 213 202 236 218 226 198 215 180 199 199 223 206 198 193 194 222 228 174 221
228 228 233 198
200 216 209 241 222 238 200 221 188 205 199 228 218 209 198 206 237 230 193 233
238 244 243 208
201 224 211 253 234 249 206 227 189 205
215 248 241 199 245
242 256 254 219
205 229 219 259 244 258 209 231 187 212
222 256 246 210 243
248 261 254 219
215 231 222 258 250 263 214 227 189 214
214 258 251 206 247
Covance 6329-225 3M T-6314.1
PAGE: 6
WEEK
260 263 267 224
223 239 226 268 255 269 219 239 198 216
WEEK 10
267 276 270 237
224 239 227 271 263 277 224 241 202 221
222 227 262 264 257 257 218 222 258 262
V'
Q 0? CD O
195
CO0331
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 11
WEEK 12
GROUP: C959Q1 C95902 C959Q3 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C95916 C95917 C95918 C95919 C95920
MALE 1 - 0 PPM 481 492 505 514 484 493 501 516 478 488 525 539 468 481 508 517 430 448 550 579 561 570 529 542 493 505 520 532 511 526
GROUP : MALE 2 - 3 PPM
C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95936 C95937 C95938 C95939
483 480 499 494 438 447 468 495 502 490 568 463 517 451
494 494
505 503 474 457 485 501 517 502 575 444 515 465
WEEK 13
508 533 510 531 495 561 501 526 459 596 588 559 520 551 545
500 510 529 520 498 468 497 515 540 519 577 459 532 474
WEEK 14
523 542 518 539 509 581 511 543 475 623 601 577 535 567 557
512 527 531 527 510 479 511 524 549 525 585 482 544 483
196
Covance 6329-225 3M T-63I4.1
PAGE: 7
Appendix 3 Individual Body weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 11
WEEK 12
<5
CO eo
GROUP: MALE 2 - 3 PPM
C95940
487
504
G R O U P : MALE 3 - 30 PPM
C95941
C95942
C95943 C95944 C95945 C95946 C95947
C95948 C95949 C95950 C95956 C95957
C95958 C95959 C95960
442119
501 444 486 476 457 478 534 473 518 479 471 448 460
442276
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
WEEK 13
518
435 449 529 466 513 492 463 504 517 495 543 499 500 467 477
513 457 501 485 443 468 472 485 485
WEEK 14
524
448 454 534 475 524 502 471 515 413 502 558 516 502 476 481
522 468 511 499 453 482 480 494 500
197
Covance 6329-225 3M T-6314.1
PAGE: 8
00333
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 11
WEEK 12
GROUP: MALE 4 - 100 PPM
C95970 C95976 C95977
C95978 C95979 C95980
460 393 458 465 441 442
462 404 469 475 452 450
GROUP: FEMALE 1 - 0 PPM
C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95996 C95997 C95998 C95999 C96000
292 262 240 280 293 281 251 264 284 330
278 256 257 362 286
313 267 241 285 297 285 256 261 299 332
281 266 262 372 292
GROUP: FEMALE 2 - 3 PPM
C96001 C96002 C96003 C96004
245 236 234 267
253 237 231 268
WEEK 13
468 408 479 485 459 458
307 271 241 284 296 290 264 276 311 349 292 271 266 388 290
253 243 232 279
WEEK 14
473 418 490 490 469 465
331 275 246 299 312 297 272 283 310 341 291 277 267 394 298
263 251 244 298
198
Covance 6329-225 3M T-6314.1
PAGE: 9
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 11
WEEK 12
GROUP: FEMALE 2 - 3 PPM
C96005 C96006 C96007 C96008 C96009 C96010 C96017 C96018 C96019 C96020
257 251 268 289 216 274 303 299 300 257
261 258 271 296 218 275 301 292 298 261
GROUP: FEMALE 3 - 30 PPM
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96036 C96037 C96038 C96039 C96040
247 274 265 271 273 247 300 280 252 254 270 261 282 274 239
254 284 265 273 274 249 312 279 252 258 270 273 290 276 241
WEEK 13
266 266 280 300 226 283 318 307 313 260
258 283 274 278 265 257 322 290 257 262 276 269 291 285 239
WEEK 14
269 274 292 305 231 292 303 306 321 267
262 292 277 283 275 255 323 295 265 262 275 283 304 284 251
Covance 6329-225 3M T-6314.1
PAGE: 10
I^GGOj-'J
199
Appendix 3 Individual Body Weight Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 11
WEEK 12
GROUP: FEMALE 4 - 1 0 0 PPM
C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96057
C96058 C96059 C96060
222 242 232 276 269 279 224 248 203 225 228 270 256 227 267
231 246 239 2S2 271 283 226 243 207 228 224 267 262 219 269
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
Covance 6329-225 3M T-6314.1
PAGE: 11
S66000
200
APPENDIX 4
Covance 6329-225 3M T-6314.1
Individual Food Consumption Data (g) Individual Test Material Consumption Data (mg/kg/day)
C00996
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
165 168 172 174 160 173 176 182 164 165 161 166 156 158 177 183 152 151 175 179 172 165 187 191 181 179 164 172 136 SPILLED 176 188 187 185 168 181 178 207 164 168
GROUP: MALE 2 - 3 PPM
C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928
162 163 159 171 185 164 161 187
170 168 170 177
195 162 168 189
WEEK 3
171 179 176 191 175 182 169 192 154 191 162 194 169 180 163 191 184 186 231 179
168 175 175 179 SPILLED 167 165 188
WEEK 4
183 190 187 202 182 199 174 202 SPILLED 198 172 198 174 187 142 192 185 187 SPILLED 190
175 179 178 184 214 168 170 202
WEEK 5
WEEK 67
WEEK 8
WEEK 9
159 179 181 181
178 197 187 187
162 190 182 181
177 203 202 208
166
182
SPILLED
SPILLED
168 199 195 188
157 180 177 167
172 197 199 192
147 170 164 165
176 194 200 193
192 189 184 233 192
168 158 163 164 187 157 155 SPILLED
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
WEEK 10
176 170 192 190 182 177 213 215 214 184 183 192 166 161 190 192 160 153 208 SPILLED
185 178 178 240 188
187 178 187 183 203 167 173 197
193 179 176 253 183
192 171 190 183
99 165 170 189
06000
202
Appendix 4 Individual Food Consumption Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 1
WEEK 2
GROUP: MALE 2 - 3 PPM
C95929 C95930 C95931 C95932 C95933 C95934 C95935 C95936 C95937 C95938 C95939 C95940
175 186 177 194 155 SPILLED 160 165 165 172 156 161
183 195 171 189 163 172 177 189 163 174 165 171
GROUP : MALE 3 - 30 PPM
C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956
154 159 156 162 178 184 174 179 168 184 169 168 151 161 166 179 172 186 168 180 181 185 155 161 178 186 184 197 194 197 208 SPILLED
WEEK 3
WEEK 4
WEEK 5
191 195 191 218 195 176 215 SPILLED 166 173 176 172 164 169 197 197 203 197 192 175 178 184 197 204 186 187 191 199 176 184 179
158 166 152 161 166 152 190 197 162 183 186 164 191 193 179 180 189 173 166 171 152 200 188 176 197 201 181 189 188 168 193 192 167 174 192 187 202 216 200 210 214 228 SPILLED
WEEK 6
237 208
191 184 194 185 178
162 170 186 189 198 186 168 185 207 200
259
WEEK 7
WEEK 8
234 SPILLED 190 186
194 188 186 SPILLED 197 199 184 180 187 185
159 153 145 153 189 183 180 178 197 187 184 189 162 155 183 185 209 204 191 189
246 SPILLED
Covance 6329-225 3M T-6314.1
PAGE: 2
WEEK 9
WEEK 10
235 227 186 170
189 198 197 168 189
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
66600*)
203
Appendix 4 Individual Food Consumption Data (g)
13-VJEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 1
WEEK 2
GROUP : MALE 3 - 30 PPM
C95957 C95958 C95959 C95960
166 168 163 168
179 175 176 181
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
191
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
176 188 188 167
188 171 183 179 169 180 179 158 178 174
167 180 181 164
180 167 176 175 162 183 177 191 177 173
155 146 184 176 180 180 171 170 180 174
6G60GJ
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 - 0 PPM
C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95991 C95992 C95993 C95994 C95995 C95996 C95997 C95998 C95999 C96000
138 127 127 126 135 137 124 124 135 162 131 111 121 129 111 122 111 120
98 SPILLED
150 143 139 130 128 152 123 114 134 147 126 101 108 133 SPILLED 126 107 112 144 145
GROUP : FEMALE 2 - 3 PPM
C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008
SPILLED 103 106 169 125
SPILLED
119 148
SPILLED 106 113 45 120
SPILLED 122
SPILLED
WEEK 3
153 123 SPILLED 145 133 132 163 127 144 165 135 116 119 138 162 127 114 119 145 158
SPILLED 104 110 127 122
SPILLED 133 144
WEEK 4
153 116 SPILLED 137 137 138 130 125 SPILLED 170 159 116 125 146 118 127 115 119 163 SPILLED
SPILLED 121 107
SPILLED 125
SPILLED 137 148
WEEK 5
129 115 108 125 132 121 113 SPILLED 137 135
121 119 126 166 156
SPILLED 106 105 125 119 112
SPILLED 113
WEEK 6
161 126 120 138 137 SPILLED 128 130 SPILLED 156
119 SPILLED
113 171 156
121 109 106 138 125 SPILLED 132 145
WEEK 7
159 134 SPILLED 148 137 130 151 119 SPILLED 158
121 SPILLED
161 157 151
176 111 106 134 127 SPILLED 149 137
WEEK 8
129 120 102 150 135 127 129 126 SPILLED 140
113 SPILLED SPILLED
163 171
SPILLED 119
SPILLED 140 161 123 137 146
WEEK 9
104 119 SPILLED 141 136 132 132 125 SPILLED 147
109 SPILLED
119 163 SPILLED
SPILLED 113 109 144 129
SPILLED 133 135
WEEK 10
137 114 130 131 129 128 119 126 244 147
109 SPILLED
113 181 SPILLED
107 106 109 166 120 SPILLED 136 136
OGQTQO
205
Appendix 4 Individual Food Consumption Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Covance 6329-225 3M T-6314.1
PAGE: 5
ANIMAL NUMBER
WEEK 1
WEEK 2
WEEK 3
WEEK 4
WEEK 5
WEEK 6
WEEK 7
WEEK 8
WEEK 9
WEEK 10
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
SPILLED 127 148
SPILLED 167 144 132 130 153 158 137 126
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
119 151
NOT TAKEN 138 139 142 117
104 136
138 146 143 114
GROUP : FEMALE 3 - 30 PPM
C96021
S P IL L E D
178
140
142
134
152 SPILLED 127 SPILLED 117
C96022
131 SPILLED 149
150 SPILLED 141
140
127
131
127
C96023
117
125
131
137
113
154
131
138
131
130
C96024
129
126
129
134
117
132 SPILLED 131
121
121
C96025
133
123
135
135
120
137
129
134
139
127
C96026
SPILLED
SPILLED
SPILLED
SPILLED
SPILLED
155
SPILLED
SPILLED
SPILLED
171
C96027
208
SPILLED
188
SPILLED
SPILLED
181
SPILLED
SPILLED
164
162
C96028
124
137
132
135
120
128
138
137
139
134
C96029
129 SPILLED 159
135
115
SPILLED
SPILLED
158
SPILLED
220
C96030
131
130
138
139
130
139
146
130
133
130
C96031
135 SPILLED 163 SPILLED
C96032
124
140
128
131
C96033
124
129
137
133
C96034
162
139
139
164
C96035
149
151
136
142
W7* C96036
117
118
122
118
SPILLED
159
SPILLED
138
SPILLED
SPILLED
o p
206
Appendix 4 Individual Food Consumption Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
Covance 6329-225 3M T-6314,1
PAGE: 6
ANIMAL NUMBER
WEEK 1
WEEK 2
GROUP; FEMALE 3 - 3 0 PPM
C96037 C96038 C96039 C96040
130 120 185 SPILLED
127 161 SPILLED SPILLED
GROUP : FEMALE 4 - 100 PPM
C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96051 C96052 C96053 C96054 C96055 C96056 C96057 C96058 C96059 C96060
135 100 107 136 118 SPILLED 108 128 101 133 101 149 113 SPILLED 105 109
175 124 118 129
110 92
104 127 128 SPILLED 107 111 SPILLED SPILLED 107 126 108 SPILLED 100 108 133 133 143 123
WEEK 3
178 SPILLED SPILLED SPILLED
109 96
103 137 124 127 105 102
99 124 101 140 118 SPILLED 104 110 130 124 107 116
WEEK 4
SPILLED SPILLED SPILLED SPILLED
120 99
105 142 145 130
99 111 102 120 106 128 121 151 108 116 159 121 121 120
WEEK 5
WEEK 67
WEEK 8
WEEK 9
WEEK
125 SPILLED SPILLED SPILLED
130 194 SPILLED SPILLED
129 SPILLED SPILLED SPILLED
136 SPILLED
159 SPILLED
127 SPILLED SPILLED
225
106 99
102 132 124 128 102 100
94 104
125 117 113 107 106 109 109 105 102 142 129 141 148 142 140 136 SPILLED 151 106 104 109 110 102 111 105 98 106 117 114 109
111 104 104 135 146 149
103 114 108 111
112 111 103 107 101
149 137 132 133 124
127 125 129 124 121
121
124
125
SPILLED
SPILLED
122 115 125 121 123
WEEK 10
122 149 SPILLED SPILLED
110 96
106 128 140 125 100 115 102 108
102 135 127 SPILLED 115
ZO O v 3
207
Appendix 4 Individual Food Consumption Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFQNAMIDO 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
bo
to
208
Covance 6329-225 3M T-6314.1
PAGE: 7
01004
Appendix 4 Individual Food Consumption Data (g)
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL {N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 11
WEEK 12
GROUP: MALE 2 - 3 PPM
C95940
184
184
GROUP: MALE 3 - 30 PPM
C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95956 C95957 C95958 C95959 C95960
147 166 175 162 183 SPILLED 143 182 192 184 233 164 184 183 161
145 169 181 163 182 174 141 178 175 190 224 167 182 185 166
GROUP : MALE 4 - 100 PPM
C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969
177 159 182 177
163 175 177 197 169
178 164 183 178 169 172 177 199 170
WEEK 13
175
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 12
GROUP : MALE 4 - 100 PPM
C95970 C95976 C95977 C95978 C95979 C95980
163 SPILLED
178 170 165 174
163 146 175 175 172 174
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 C96D02 C96003 *>096004
,-S
110 112 111 134
104 114 114
138
o
Crt
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 PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
WEEK 11
WEEK 12
GROUP: FEMALE 2 - 3 PPM
C96005 C96006 C96007 C96008 C96009 C96010 C96017 C96018 C96019 C96020
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
Covance 6329-225 3M T-6314.1
PAGE: 10
C01006
211
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 C9648 C96049 C96050 C96056 C96057 C96058 C96059 C96060
108 97
103 131 133 123
97 118 106 107
97 SPILLED
119 SPILLED
118
106 99 99
129 137 122 100 118 105 112
96 132 120 SPILLED
116
WEEK 13
103 96 96
129 137 128 105 125 103 106 101 131 197 SPILLED 112
Covance 6329-225 3M T-6314.1
PAGE: 11
r> 'TS*
o vj
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
WEEK 3
WEEK 4
WEEK 5
WEEK 6
WEEK 7
WEEK 8
WEEK 9
WEEK 10
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 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2
0.3 0.3 0.2 0.2 0.2 0.2 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 0.2
0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2
0.3 0.3 SPILLED 0.2 0.2 0.2 0.2 0.2 0.2 0.1
0.3 0.3 0.2 0.2 0.2 0.2 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 0.2
0.4 0.3 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 0.2
0.3 0.3 0.2 0.2 0.2 0.3 0.2 SPILLED 0.2 0.2
0.3 0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2
0.3 SPILLED
0.3
SPILLED
NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
0.3 0.3 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN N OT TAKEN NOT TAKEN NOT TAKEN
0.3 0.3 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
0.3 0.3 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
0.3 0.3 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN N OT TAKEN NOT TAKEN NOT TAKEN
0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.1
0.3 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2
0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2
0.3 0.3 0.3 0.2 0.2 0.2 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 0.2
GROUP : MALE 3 - 30 PPM
C95941
C95942
C95943
> C95944
U
C95945 C95946
b C95947
o C9594B
QO
3.0 2.6 2.2 2.2 1.9 1.9 1.8 1.7 1.5 1.5 3.0 2.6 2.2 2.1 1.8 2.0 1.7 1.7 1.7 1.7 3.0 2.6 2.3 2.2 1.7 1.9 1.8 1.7 1.7 1.5
3.2 2.7 2.4 2.2 1.9 2.1 1.9 1.8 1.7 1.6 3.1 2.7 2.4 2.2 2.0 2.1 2.0 1.8 1.7 1.6 3.2 2.6 2.4 2.3 2.0 2.0 1.9 1.9 1.7 1.6 2.9 2.5 2.2 2.1 1.7 1.9 1.7 1.6 1.5 1.4 3.0 2.6 2.5 2.2 1.9 1.9 1.8 1.8 1.7 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 - 3 0 PPM
C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956 C95957 C95958 C95959 C95960
3.0 2.6 3.0 2.6 2.9 2.4 2.9 2.5 3.3 2.8 3.1 2.8 3.6 2.9 3.8 SPILLED 2.8 2.5 3.1 2.6 3.2 2.8 3.0 2.7
GROUP: MALE 4 - 100 PPM
C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970
C95971 C95972 C95973 C95974 C95975 C95976
10.2 9.9
10.2 10.1 10.3 10.2 10.6 11.6 10.4
9.5 10.0 10.1 11.3 10.4
9.8 10.4
8.7 8.8 8.5 9.4 9.1 9.0 9.1 9.3 8.6 9.3 8.6 8.7 9.6 9.3 8.5 9.1
WEEK 3
2.4 2.4 2.2 2.3 2.5 2.5 2.6 2.7 2.3 2.4 2.5 2.3
7.7 7.7 7.5 7.7 8.1 8.1 7.9 8.3 7.6 SPILLED 7.7 7.6 8.3 7.9 7.5 7.9
WEEK 4
WEEK 5
WEEK 6
WEEK 7
WEEK 8
WEEK 9
WEEK 10
2.2 1.8 2.0 1.9 1.8 1.7 1.6 2.1 1.8 2.0 1.9 1.8 1.8 1.6 2.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.3 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.4 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.5 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.6 SPILLED 2.5 2.3 SPILLED 1.9 1.9 2.1 2.0 1.9 1.8 1.7 1.6 1.5 2.2 2.0 2.1 1.8 1.8 1.8 1.7 2.4 2.2 2.2 2.0 2.0 1.9 1.8 2.3 2.1 1.8 1.8 1.7 1.6 1.5
7.2 6.0 6.7 6.2 5.9 5.6 5.2 7.2 6.3 6.9 6.5 6.0 5.9 5.6 6.9 6.2 6.6 6.1 5.9 5.7 5.3 7.6 6.3 6.5 6.4 6.0 5.7 5.4 7.6 6.6 7.1 6.5 6.1 6.0 5.6 7.4 6.2 6.9 6.5 6.1 6.0 5.9 7.3 6.1 6.6 6.5 6.1 5.9 5.7 7.8 6.4 6.9 6.5 5.3 5.2 6.0 7.1 5.8 6.5 6.2 5.9 5.6 5.4 7.2 6.2 6.8 6.2 6.0 5.5 5.4 6.4 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.9 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.9 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.4 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.3 6.7 6.6 6.4 6.0 5.8 5.3
G O T i/5
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 6329-225 3M T-6314.1
PAGE: 3
ANIMAL NUMBER
WEEK 1
WEEK 2
GROUP: MALE 4 - 100 PPM
C95977 C95978 C95979 C95980
10.0 9.9
10.6 10.2
9.0 8.4 9.0 8.9
GROUP: FEMALE 2 - 3 PPM
C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 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 6
WEEK 7
WEEK 8
WEEK 9
WEEK 10
6.7 6.7 6.5 6.1 6.0 5.6 6.4 6.1 5.9 5.8 5.8 5.6 7.1 6.4 6.4 5.9 5.8 5.6 6.8 6.6 6.5 6.2 5.9 5.7
SPILLED 0.2 0.2 0.2 0.2 0.2
SPILLED 0.2 0.2 0.2
NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
0.2 0.2 SPILLED 0.2 0.2
0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.3 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2
0.3 0.2 0.2 0.2 0.2 SPILLED 0.3 0.2 0.4 SPILLED NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2
SPILLED 0.2
SPILLED 0.2 0.3 0.2 0.2 0.2 0.3 0.2
NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
0.2 0.2 SPILLED 0.2 0.2
SPILLED 0.2 0.2 0.2 0.2
SPILLED 0.2 0.2 0.2 0.2
NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
0.2 0.2 0.2 0.2
0.2 0.2 0.2 0.3 0.2 SPILLED 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2
b
o
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 1
WEEK 2
GROUP: FEMALE 3 - 3 0 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 67
WEEK 8
WEEK 9
WEEK
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
o
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 - 1 0 0 PPM
C96049 C96050 C96051 C96052 C96053 C96054
C96055 C96056 C96057
C96058 C96059 C96060
9.6 12.1
9.1 11.5 10.1 SPILLED
9.3 9.5 13.8 9.8 11.1 10.4
SPILLED SPILLED
8.8 9.0 8.9 SPILLED 8.4 8.5 9.2 9.1 12.0 8.8
WEEK 3
8.2 9.2 7.5 9.3 8.8 SPILLED 8.1 8.2 8.4 7.8 8.7 7.6
WEEK 4
WEEK 5
WEEK 67
WEEK 8
WEEK 9
WEEK
WEEK 10
7.9 8.5 7.6 8.1 8.2 10.6 7.9 8.3 9.9 7.5 9.4 7.6
7.1 7.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.6 8.8 7.7 8.8 7.3
8.0 8.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.3 7.8 7.3 8.7 6.7
7.4 7.6 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.7 7.3 7.4 8.6 7.3
7.8 7.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.0 7.3 7.0 SPILLED 6.8
7.7 7.3 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.4 6.7 6.7 SPILLED 6.8
7.2 6.9 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.4 7.2 7.1 SPILLED 6.2
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
0000 .... 2222
0.2
0.1 0000.... 2222
NOT TAKEN NOT TAKEN
NOT TAKEN
NOT TAKEN
NOT TAKEN
0.1 0.1
0.2 0.2 0.2
PPM
00 .. 22 000... 222 0000 ....1222
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
0.1 000 ...122 0.1 0.1 0.1 0.1
0.1 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
0.1 0.2 0.1 0.1 0.1
1.3 1.7 1.4 1.4 1.6 1.4 1.3 1.5
b
CO 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 - 1 0 0 PPM
C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 C95971 C95972 C95973 C95974 C95975 C95976
5.0 5.2 5.4 5.4 5.5 5.5 5.6 6.1 5.1 5.1 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED
5.0 5.2 5.3 5.3 5.5 5.3 5.4 6.0 5.0 5.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 5.1
0.1 1.6 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 1.6 1.4 1.5 1.6 1.4
4.9 4.8 4.9 5.2 5.4 4.9 5.0 5.1 4.9 4.8 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 5.1
o
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
C96Q01 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
o P m.
220
Covance 6329-225 3M T-6314.1
PAGE : 8
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 - 3 0 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
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
GROUP : FEMALE 4 - 100 PPM
C96041
C96042
C96043
C96044
C96045
C96046
`-We**^
C96047 C96048
6.8 6.5 6.3 5.7 5.7 5.5 6.2 5.9 5.7 6.7 6.5 6.5 7.0 7.2 7.1 6.3 6.1 6.4 6.2 6.3 6.6 6.9 6.9 7.1
Covance 6329-225 3M T-6314.1
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 - 1 0 0 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
r>
P O sl
222
APPENDIX 5
Individual Clinical Hematology Data Individual Clinical Chemistry Data Individual Clinical Urinalysis Data
Covance 6329-225 3MT-6314.1
C O lO iS
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 NUMBER
RBC x i o 6/a<l
HGB G/DL
HCT %
MCV FL
MCH PG
MCHC %
PLT 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
HCT
MCV
MCH
MCHC
PLT
NUMBER
XIOV^L
G/DL
%
FL PG % X I O V ^ 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. 10
1141 1097 1177
986 1166
948 1001 1296 1032
970
1081 112. 10
Covance 6329-225 3M T-6314.1
t lJ
C O IO
225
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 X 1 0 3/^L
Appendix 5
Individual Clinical Hematology Data
Males
Week 5
13-WEEK DIETARY 1TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE , T-6314) IN RATS
N-SEG X103/m L
LYMPH X 1 0 3//rL
MONO
X 1 0 3/ m L
EOS IN X 1 0 3/AiL
BASO
X 1 0 3/ u L
N-SEG%
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
3
10 10 10 10 10 10 10 10 10 10 10
Dose Level : 3
Dosage Uni t : 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
I
o
to
b*
226
ANIMAL NUMBER
WBC XIOV^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 xioV ml
LYMPH X103/m L
MONO
EOSIN
X 103/a(L X103/^L
BASO
N-SEG%
X1 0 3/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 4 1 1
C95948 13.2 .6 12.0 .4 .1 .0 4 92 3 1 0
C95949
9.1 .5 8.2 .3 .0 .0 5 90 4 0 0
C95950
9.5 .5 8.3 .7 .1 .0 5 87 7 1 0
MEAN S.D. N
10.0 .5 9.0 .4 .1 .0 5 90 4 1 0
2.48 .15 2.27 .13 .06 .04
1. 4
1. 8
1..1
.3
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 1 1
C95963 10.1 .5 8.9 .6 .1 .0 5 88 6 1 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 6 1 0
C95966
14.0
1.4 11.6
.8
.2
.0 10
83
6
1
0
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
1
0
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
10 10 10 10 10 10 10 10 10 10 10
O ToO
n
iti
227
Appendix 5
Individual Clinical Hematology Data
Males
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910
Group: 2
C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930
Dose Level: 0
----------
Dose Level: 3
--
-----_ --
-
-
-
-
-
Dosage Unit: ppm MeFOS
---------
--
Dosage Unit: ppm MeFOS
--
------
--
Covance 6329-225 3M T-6314.1
*>
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
O f3
229
OTOO
it:n
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
RBC X 106/aL
HGB G/DL
HCT %
MCV FL
MCH PG
MCHC %
PLT XlOV^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
35.3 34.3 34.2 35.1 34.5 34.5 35.1 35.7 34.9 33.5
34.7 .64 10
1230 1254 1094 1137 1012 1085
913 1190 1056 1171
1114 104. 10
1297 1181 1107 1267 1139 1166 1106 1303 1083 1129
1178 82. 10
Covance 6329-225 3M T-6314.1
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 NUMBER
RBC X1 0 6/aL
HGB G/DL
HCT %
MCV FL
MCH PG
MCHC %
PLT XIOV^L
Group: 3
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030
MEAN S.D. N
Group: 4
C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050
MEAN S.D. N
Dose Level: 30
8.61 7.97 7.34 8.01 8.17 7.78 7.86 7.66 8.04 8.36
16.6 16.0 15.2 16.2 15.7 16.0 16.3 15.3 15.6 16.9
7.98 .357 10
16.0 .55 10
Dose Level: 100
7.44 7.66 8.63 7.63 8.13 7.84 7.91 7.76 7.95 7.95
14.5 15.1 16.5 15.3 15.7 15.7 15.8 15.1 15.2 15.7
7.89 .326 10
15.5 .54 10
Dosage Unit: ppm MeFOS
48.3 45.7 43.4
46.3 45.2
45.2 46.6 43.5 44.5 49.3
56.1 57.4 59.1 57.8 55.4 58.2
59.3 56.8 55.4 58.9
19.3 20.1 20.7
20.2 19.2 20.6 20.7 20.0 19.5 20.2
45.8 1.91 10
57.4 1.48 10
20.0 .56 10
Dosage Unit: ppm MeFOS
41.9
43.1 47.5 44.9 45.9 46.0 43.4 44.1 44.9 44.8
56.4 56.2
55.1 58.8 56.5 58.7 54.9 56.8 56.4 56.3
19.5 19.7 19.1 20.1 19.3 20.0 19.9 19.5 19.2 19.8
44.7 1.62 10
56.6 1.28 10
19.6 .34 10
34.4 35.0 35.1 35.0 34.8 35.5 35.0 35.3 35.1 34.3
35.0 .37 10
34.6 35.1 34.6 34.2 34.2 34.0 36.3 34.4 34.0 35.2
34.7 .71 10
1199 1084 1037 1029 1082 1124 1057 1414 1199 1007
1123 121. 10
1007 1191 1235 1059 1091
535 1151 1333
942 1032
1058 217, 10
Covance 6329-225 3M T-6314.1
O m
231
ANIMAL NUMBER
WBC XIOV^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 X 1 0 3/^L
LYMPH XIOVm L
MONO X1 0 3/m L
EOSIN xioV ml
BASO
N-SEG%
X l O '/^iL
LYMPH%
MONO%
EOSINfc
Covance 6329-225 3M T-6314.1
BASO%
Group : 1
Dose Level : 0
Dosage Unit: ppm MeFOS
C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990
8.2 1.1 6.4 .6 .1 .0 14 77 8 1 0 7.6 .7 6.3 .5 .1 .0 9 83 6 1 1 5.3 .4 4.6 .2 .0 .0 7 88 5 1 0
7.3 .2 6.8 .3 .0 .0 3 93 4 1 0 7.6 .5 6.6 .4 .1 .0 7 87 5 1 0 6.8 .2 6.3 .2 .0 .0 4 92 3 1 0 3.3 .2 2.9 .1 .0 .0 7 89 3 1 0 6.9 .5 5.9 .3 .1 .0 7 87 5 2 0 5.2 .3 4.5 .3 .0 .0 7 87 5 1 0 4.6 .2 4.1 .3 .0 .0 4 89 6 1 0
MEAN S.D. N
6.3 .4 5.4 .3 .0 .0 7 87 5 1 0
1.59 .29 1.32 .15 .05 .00
3.1 4.5 1. 5
.3
10 10 10 10 10 10 10 10 10 10 10
Group : 2
Dose Level : 3
Dosage Unit: ppm MeFOS
C96001
5.7 .5 5.1 .1 .1 .0 9 88 1 1 0
C96002
3.5 .3 3.0 .1 .0 .0 9 86 4 1 0
C96003
7.6 .7 6.3 .4 .2 .0 10 83 5 2 0
C96004
7.2 .3 6.5 .4 .1 .0 4 90 5 1 0
C96005 11.1 .3 10.6 .2 .0 .0 2 96 1 0 0
C96006
5.8 .4 5.0 .3 .0 .0 6 88 5 1 0
C96007
10.4
.4 9.7
.3 .1 .0
4 93
3
1
0
C96008
7.0 .4 6.2 .3 .1 .0 5 89 5 1 0
C96009
7.9 .8 6.6 .3 .1 .0 10 84 4 2 0
C96010
7.4 .8 6.4 .1 .0 .0 11 86 2 0 0
MEAN S.D. N
U
O
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 XlOVL
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/^L X103/KL
MONO
EOSIN
XloV/iL X103/AiL
BASO
N-SEG%
X1 0 3/m L
LYMPH%
MONO%
EOSIN%
Covance 6329-225 3M T-6314.1
BASO%
Group: 3
Dose Level : 30
Dosage Unit: ppm MeFOS
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030
7.7 .3 7.0 .2 .1 .0
4 92
6.2 .3 5.6 .3 .0 .0
4 90
5.1 .8 3.8 .4 .1 .0 16 74
5.9 .4 5.2 .2 .1 .0
7 88
5.7 .3 5.2 .2 .1 .0
5 90
9.7 .5 8.8 .2 .1 .0
6 91
10.9 .6 9.6 .7 .1 .0
5 88
6.7 .4 5.9 .3 .0 .0
6 88
4.4 .7 3.6 .1 .0 .0 15 81
11.1 .7 9.6 .6 .1 .0
7 87
31 41 82 31 31 21 61 51 31 51
0 0 0 0 0 0 0 0 0 0
MEAN S.D. N
7.3 .5 6.4 .3 .1 .0 8 87 4 1 0
2.42 .19 2.24 .19 .05 .00
4..4
5. 4
1,.8
.3
10 10 10 10 10 10 10 10 10 10 10
Group: 4
Dose Level : 100
Dosage Unit: ppm MeFOS
C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050
10.2 .3 9.6 .3 .1 .0
3 94
2
6.7 .4 5.9 .3 .1 .0
7 88
4
8.9 .5 7.9 .4 .1 .0
6 88
5
6.6 .8 5.4 .3 .1 .0 12 82
4
10.8 .4 9.1 1.1 .1 .1
4 84 10
5.7 .2 5.2 .2 .0 .0
3 92
4
6.6 .4 5.8 .3 .1 .0
6 88
4
5.7 .7 4.8 .2 .1 .0 12 84
3
7.3 .4 6.7 .2 .0 .0
5 91
3
4.2 .5 3.4 .3 .1 .0 12 80
7
1 1 1 2 1 1 1 1 1 1
0 0 0 0 1 0 0 0 0 0
MEAN S.D. N
o
ro
09
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 l-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
e
n ID
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
GTOO
(-3
O
235
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
RBC X1 0 6/a<L
HGB G/DL
HCT %
MCV FL
MCH MCHC
PLT
PG % X I O V ^ 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
XCO Tt/3
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 NUMBER
RBC
X 1 0 e/ n L
HGB G/DL
HCT %
MCV FL
MCH PG
MCHC %
PLT xioV ml
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
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
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
33.3 31.6 32.7 32.7 32.3 32.9 31.6 33.9 32.6 33.0
1015 1065 1109
932 1107 1006
636 986 1100 1045
MEAN S.D. N
8.68 .535 10
15.2 .56 10
46.8 1.99 10
54.0 1.79 10
17.6 .82 10
32.7 .71 10
1000 140. 10
Group : 4
Dose Level : 100
Dosage Unit: ppm MeFOS
C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980
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
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
33.0 32.8 32.7 33.3 33.6 33.0 32.8 32.7 33.3 33.1
957 992 1153 1014 1104 907 1306 902 878 897
MEAN S.D.
8.25 .273
14.6 .71
44.3 1.92
53.7 1.39
17.7 .56
33.0 .30
1011 138.
N 10 10 10 10 10 10 10
u
0
GTG )
237
ANIMAL NUMBER
WBC XIOV^L
Appendix 5
Individual Clinical Hematology Data
Males
Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
N-SEG
LYMPH
X103/L X103/^L
MONO
EOSIN
X1 0 3/a<L X1 0 3/^iL
BASO
N-SEG%
X 1 0 3/^L
LYMPH%
MONO%
EOSIN%
Covance 6329-225 3M T-6314.1
BASO%
Group : 1
Dose Level: 0
Dosage Unit: ppm MeFOS
C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920
7.5 .8 6.0 .6 .1 .0 11 80 7 1 0
6.0 .9 4.8 .2 .0 .0 15 81 4 1 0
6.8 1.2 4.9 .6 .1 .0 17 72
92
0
6.0 .7 4.8 .5 .1 .0 11 79 8 2 0
6.4 .6 5.3 .3 .1 .0 10 82 5 2 0
6.0 1.0 4.4 .5 .1 .0 16 74 8 2 1
6.9 1.0 5.2 .6 .1 .0 15 75 9 1 0
7.0 .6 5.7 .6 .1 .0 8 82 8 1 1
8.8 .8 7.4 .4 .1 .0 10 84 5 2 0
7.4 1.5 5.4 .4 .1 .0 21 73 5 1 0
MEAN S.D. N
6.9 .9 5.4 .5 .1 .0 13 78 7 2 0
.88 .28 .85 .14 .03 .00
4.0 4.3 1.9
.5
.4
10 10 10 10 10 10 10 10 10 10 10
Group : 2
Dose Level: 3
Dosage Unit: ppm MeFOS
C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939
4.8 .8 3.6 .3 .1 .0 16 76 6 2 0
7.0 1.1 5.0
.6 .2
.0 16 72
9
3
0
7.7 .9 6.4 .4 .1 .0 12 83 5 1 0
6.1 1.4 4.2 .4 .1 .0 23 69 6 1 0
8.0 1.3 5.9 .6 .2 .0 16 73 8 2 0
6.4 .8 5.1 .3 .2 .0 12 80 5 2 0
6.0 1.0 4.0
.8 .1
.0 17 66 14
2
1
7.2 .9 5.7 .4 .2 .0 13 80 5 2 0
4.3 .7 3.2 .2 .1 .0 17 75 5 2 0
9.2 1.1 7.5
.5 .1
.0 12 81
6
1
0
MEAN S.D. N
6.7 1.0 5.1
.4 .1
.0 15 76
7
2
0
1.48 .23 1.35 .18 .05 .00
3.4 5.6 2.8
.6 .3
10 10 10 10 10 10 10 10 10 10 10
CCOT UO
238
ANIMAL NUMBER
WBC X 1 0 3/>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 XloV^L
LYMPH XIOV^L
MONO X 103/aiL
EOS IN XloV^iL
BASO
N-SEG%
x i o V aL
LYMPH%
MONO%
EOSIN%
Covance 6329-225 3M T-6314.1
BASO%
Group: 3
Dose Level : 30
Dosage Unit : ppm MeFOS
C95941 10.8 1.2 9.0 .4 .1 .0 11 84 3 1 0
C95942
3.7 .7 2.8 .1 .0 .0 20 76 3 1 0
C95943
7.9 .8 6.4 .5 .1 .0 10 82 7 1 0
C95944
6.1 .7 4.9 .4 .1 .0 11 81 6 2 0
C95947 12.0 .9 10.6 .3 .1 .0 8 88 3 1 0
C95948 10.8 .7 9.5 .5 .1 .0 6 88 4 1 0
C95949
7.4 1.3 5.3 .6 .1 .0 18 72 9 1 0
C95950
5.9 .9 4.5 .4 .1 .0 15 76 7 2 0
C95958
6.2 1.1 4.6 .3 .2 .0 18 74 5 3 0
C95960
6.0 .6 4.9 .4 .1 .0 10 82 6 1 0
MEAN S.D. N
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
Group: 4
Dose Level : 100
Dosage Unit : ppm MeFOS
C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980
5.0 .8 3.9 .2 .1 .0 17 77
5.9 1.0 4.6 .3 .1 .0 16 77
8.8 1.0 7.4 .3 .1 .0 11 84
6.7 1.2 5.0 .4 .1 .0 18 74
5.4 1.1 4.0 .2 .1 .0 20 74
4.4 .7 3.3 .4 .0 .0 15 75
12.7
1.6 10.0
1 .0
.2
.1
12
78
10.3 1.8 7.8 .4 .1 .0 18 76
5.9 .8 4.6 .3 .1 .0 14 79
6.6 1.1 5.0 .4 .1 .0 16 76
410 510 32 0 610 410 81 0 811 410 610 62 0
MEAN S.D. N
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
o
u
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 C9591B C95919 C95920
Dose Level: 0
-----------
-
-
Group: 2 Dose Level: 3
C95921
-
-
-
C95922
-
-
-
C95924
-
-
-
C95925
-
-
-
C95926
-
-
-
C95927
-
-
-
C95928
-
-
-
C95936
-
-
-
C95937
-
-
-
C95939
-
-
-
Dosage Unit: ppm MeFOS
----
-------
Dosage Unit: ppm MeFOS
-----------
Covance 6329-225 3M T-6314.1
`
O
u
cn
240
Appendix 5
Individual Clinical Hematology Data
Males
Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 3
C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960
Group: 4
C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980
Dose Level: 30
----------___ -------
Dose Level: 100
---------------------
Dosage Unit: ppm MeFOS
-----__
----
Dosage Unit: ppm MeFOS
-----------
Covance 6329-225 3M T-6314.1
o
u &
241
Q
U-a
Appendix 5
Individual Clinical Hematology Data
Females
Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
RBC X 1 0 6/aL
HGB G/DL
HCT %
MCV FL
MCH
MCHC
PLT
PG % X I O V aL
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 NUMBER
RBC X1 0 6/m L
HGB G/DL
HCT %
MCV FL
MCH PG
MCHC %
PLT X 1 0 3/ ^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
GTu')
243
ANIMAL NUMBER
WBC XIOVliL
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 X103/m L
LYMPH XIOV^L
MONO
EOS IN
X1 0 3/a<L XlOV^iL
BASO
N -SEG%
X 1 0 3/*L
LYMPH%
MONO%
EOSIN%
Covance 6329-225 3M T-6314.1
BASO%
Group: 1
C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000
MEAN S.D. N
Group : 2
C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020
MEAN S.D. N
Dose Level : 0
4.2 1.0 2.3 .3 4.9 1.9 4.8 .7 3.6 .4 5.6 1.1 3.1 .5 4.1 .9 3.6 .4 4.2 .8
4.0 .95 10
.8 .47 10
Dose Level : 3
3.6 3.1 4.0 4.0 6.7 6.6 5.0 4.3 5.3
.4 .6 .7 1.0 .5 .8 .7 .8 .6
4.7 1.27
9
.7 .18
9
Dosage Unit: ppm MeFOS
3.1 .0 .1 1.9 .1 .0 2.6 .3 .1 4.0 .0 .1 2.9 .2 .1 4.2 .2 .1 2.4 .1 .1 2.7 .3 .1 2.8 .3 .1 3.0 .2 .1
3.0 .2 .1 .69 .12 .03 10 10 10
Dosage Unit: ppm MeFOS
2.9 .3 .1 2.1 .2 .1 2.9 .2 .1 2.7 .3 .1 5.8 .3 .1 5.4 .3 .1 4.0 .3 .1 3.3 .2 .1 4.4 .2 .1
3.7 .3 .1 1.27 .05 .00
999
.0 .0 .0 .0 .0 .0 .0 .0 .0 .0
.0 .00 10
.0 .0 .0 .0 .0 .0 .0 .0 .0
.0 .00
9
24 12 39 15 11 19 15 22 11 20
19 8.5
10
10 19 19 24
8 12 13 18 11
15 5.3 9
74 82 53 82 81 75 78 67 77 72
74 8.8
10
80 70 72 67 86 82 80 75 82
77 6.4 9
1 4 7 0 6 4 4 7 9 5
5 2.8 10
7 8 6 7 4 5 5 5 5
6 1.3 9
2 2 1 2 2 2 2 3 2 3
2 .6
10
2 3 3 2 1 2 1 1 2
2 .8
9
0 0 0 0 0 0 0 1 1 0
0
10
0 0 0 0 0 0 0 0 0
0
9
fjTU 3
'(
244
V.
o
o
ANIMAL NUMBER
WBC xioV ml
Appendix 5
Individual Clinical Hematology Data
Females
Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N -METHYL 1PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
N-SEG XIOV^L
LYMPH xioV ml
MONO xioV ml
EOSIN xioV ml
BASO
N-SEG%
XI03/f ib
LYMPH%
MONO%
Covance 6329-225 3M T-6314.1
EOSIN%
BASO%
Group : 3
Dose Level : 30
Dosage Unit: ppm MeFOS
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040
6.9 .6 6.1 .1 .1 .0 8 89 2 1 0 5.1 .8 3.9 .3 .1 .0 15 77 6 1 0 5.1 .8 3.8 .4 .1 .0 16 74 8 2 0
4.9 .9 3.5 .3 .1 .0 19 72 6 2 0 4.5 .5 3.8 .2 .1 .0 10 83 4 1 0
6.6 1.9 4.2 .3 .1 .0 29 65 5 1 0 5.4 .9 4.1 .4 .1 .0 16 75 7 1 0 7.8 .6 6.7 .4 .1 .1 7 86 5 2 1 6.0 1.8 3.9 .2 .1 .0 29 65 4 1 0
4.8 .8 3.6 .3 .1 .0 17 75 6 1 0
MEAN S.D. N
5.7 1.0 4.4 .3 .1 .0 17 76 5 1 0
1.08 .49 1.10 .10 .00 .03
7. 6
8. 0
1. 7
.5
10 10 10 10 10 10 10 10 10 10 10
Group : 4
Dose Level : 100
Dosage Unit: ppm MeFOS
C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060
MEAN S.D, N
2.9 .4 2.3 .1 .0 .0 14 81 4 1 0 3.6 .6 2.8 .2 .1 .0 17 76 4 2 0
9.7 1.0 8.4 .2 .1 .0 10 86 2 1 0 6.4 .6 5.5 .3 .1 .0 9 85 4 1 1
3.9 .3 3.4 .0 .1 .0 8 89 0 1 0 4.0 1.1 2.6 .2 .1 .0 28 65 5 2 0 4.7 .4 4.1 .2 .0 .0 7 88 4 1 0 3.8 .9 2.6 .3 .1 .0 24 67 7 3 0 3.0 .4 2.5 .1 .1 .0 13 82 3 2 0 4.8 .5 4.0 .2 .1 .0 11 84 4 2 0
4.7 .6 3.8 .2 .1 .0 14 80 4 2 0
2.03 .28 1.89 .09 .04 .00
7.,0
8. 4
1. 8
.7
10 10 10 10 10 10 10 10 10 10 10
245
Appendix 5
Individual Clinical Hematology Data
Females
Week 14
13-WEEK DIETARY TOXICITY STUDY WITH I[-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000
Group: 2
C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020
Dose Level: 0 Dose Level: 3
Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS
Covance 6329-225 3M T-6314.1
^
O
246.
Appendix 5
Individual Clinical Hematology Data
Females
Week 14
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFOMAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 3
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040
Group: 4
C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060
Dose Level: 30
-----------
Dose Level: 100
Dosage Unit: ppm MeFOS
-----Dosage Unit: ppm MeFOS
Covance 6329-225 3M T-6314.1
247
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
Appendix 5
Individual Clinical Chemistry Data
Males
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
GLU MG/DL
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL MG/DL
TRIG MG/DL
Covance 6329-225 3M T-6314.1
Dose Level : 0
Dosage Uni t : ppm MeFOS
101 9 98 11
109 14 107 12
96 11 100 9 107 9 110 13
94 12 105 9
.7 7.3 4.8 2.5 .7 7.3 4.8 2.5 .6 7.0 4.5 2.5 .7 6.5 4.4 2.1 .6 7.0 4.8 2.2 .6 7.4 5.0 2.4
.5 6.3 4.3 2.0 .7 7.1 4.9 2.2
.6 6.5 4.7 1.8 .7 6.7 4.8 1.9
.2 60 47
.2 57 31
.2 76 33
.2 50 40
.2 56 42
.2 83
94
.2 32 37
.2 76 33
.2 54 49
.2 47
46
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
Dose Level : 3
Dosage Unit: ppm MeFOS
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
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
0T><)
248
ANIMAL NUMBER
Appendix 5
Individual Clinical Chemistry Data
Males
week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
GLU MG/DL
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL MG/DL
TRIG MG/DL
Covance 6329-225 3M T-6314.1
Group: 3
Dose Level : 30
Dosage Uni t : ppm MeFOS
C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950
93 12 114 10 129 11
91 10 111 10 104 15 116 14 124 11
84 11
90 11
.6 6.5 4.8 1.7 .6 7.1 4.8 2.3 .6 6.5 4.6 1.9 .6 6.8 4.7 2.1 .6 6.5 4.5 2.0 .6 6.9 4.8 2.1 .6 6.4 4.6 1.8 .6 6.6 4.9 1.7 .6 6.7 4.6 2.1 .5 6.5 4.5 2.0
.2 51 41
.2 48 63
.2 46 26
.2 67 40
.2 42 30
.2 58 33
.1 73
39
.2 57 39
.2 54 49
.2 40 36
MEAN S.D. N
106 12 .6 6.6 4.7 2.0 .2 54 40
15.6
1..7
.03
.22
.14
.19
.03
10.,6
10
10 10 10 10 10 10 10 10 10
Group: 4
Dose Level : 100
Dosage Unit: ppm MeFOS
C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970
152 17 90 11 97 12
102 13 94 12
110 13 99 13
111 12 105 13
98 13
.7 6.4 4.4 2.0 .6 6.6 4.7 1.9 .7 6.8 4.8 2.0 .6 6.4 4.8 1.6 .6 7.0 4.9 2.1 .5 6.3 4.4 1.9 .6 6.9 4.8 2.1 .6 7.1 4.8 2.3 .5 6.5 4.5 2.0 .6 7.0 5.0 2.0
.2 26 .2 25 .2 60 .2 64 .2 41 .2 34 .2 55 .2 54 .2 35 .2 51
12 27 45 29 25 16 24 35 17 18
MEAN S.D. N
106 13 .6 6.7 4.7 2.0 .2 44 25
17.5
1. 6
.07
.29
.21
.18
.00 14. 1 9
10 10 10 10 10 10 10 10 10
0 T t,-3
249
pk
o
{i>n
ANIMAL NUMBER
Appendix 5
Individual Clinical Chemistry Data
Males
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
AST/SGOT ALT/SGPT
IU/L
IU/L
GGT IU/L
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: i
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 L e v e l :: 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 L e v e l ;: 3
92 33 115 35
95 39 86 26 79 29 108 41 74 35 123 32 83 30 103 30
96 16.1 10
33 4.6
10
Dosage Unit: ppm MeFOS
1 11.7 10.2
0 11.3
9.9
1 11.0
9.0
0 10.4 10.5
0 10.4
8.5
0 11.6
9.6
1 10.5
8.9
0 11.0
9.7
0 10.7
9.3
0 10.8
9.3
0 .5
10
10.9 .47 10
9.5 .61 10
Dosage Unit: ppm MeFOS
0 11.1 11.1
1 10.6
9.0
0 10.7 10.3
1 11.0 10.3
0 10.7
9.0
0 10.9
9.5
0 11.1
9.6
0 10.9 10.5
0 10.7
9.7
1 10.6
9.1
0 .5
10
10.8 .19 10
9.8 .71 10
149 149 145 146 148 146 147 147 147 146
147 1.3
10
6.6 6.8 6.1 5.7 6.1 6.8 6.4 6.1 6.0 5.8
6.2 .39 10
150 145 147 147 145 147 146 149 147 148
147 1 ..6
10
7.0 6.0 7.0 6.1 5.9 6.1 5.9 6.2 5.9 6.3
6.2 .42 10
107 107 102 103 107 101 106 104 103 106
105 2
10
108 102 105 106 105 104 104 105 103 105
105 1
10
Covance 6329-225 3M T-6314.1
250
ANIMAL NUMBER
Appendix 5
Individual Clinical Chemistry Data
Males
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
AST/SGOT ALT/SGPT
IU/L
IU/L
GGT IU/L
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 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 L e v e l : 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 0 10.8 2 10.1 0 10.9 0 10.6 0 10.3 0 10.1 1 10.6 1 10.4 0 10.9
9.0 9.0 8.7
9.9 9.0 7.7 8.2 10.4 8.9 9.5
0 .7
10
10.5 .30 10
9.0 .78 10
Dosage Unit: ppm MeFOS
0 10.2 11.4
0 10.2
8.9
0 10.9
9.6
1 10.8
9.0
0 10.6
9.3
0 10.0
7.9
0 11.2
9.2
0 10.9
9.1
0 10.0
7.8
0 10.7
8.3
0 .3
10
10.6 .42 10
9.0 1.02
10
147 150 147 147 146 147 147 148 149 147
148 1. 2
10
6.6 6.5 6.3 6.6 5.4 5.2 5.6 6.0 6.3 6.5
6.1 .52 10
146 148 148 149 148 143 150 146 142 146
147 2. 5
10
5.8 6.0 6.5 6.5 6.5 5.1 6.1 6.5 6.1 5.7
6.1 .46 10
106 107 105 105 104 108 107 107 105 106
106 1
10
103 107 106 109 104 104 108 103 102 102
105 2
10
Covance 6329-225 3M T-6314.1
OTfy 3
251
ANIMAL NUMBER
Group : 1
C959S1 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
Appendix 5
Individual Clinical Chemistry Data
Females
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
GLU MG/DL
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL MG/DL
TRIG MG/DL
Covance 6329-225 3M T-6314.1
Dose Level : 0
Dosage Unit: ppm MeFOS
101 13 119 11 117 13 111 13 110 14
92 12 105 11
99 13 120 12 111 10
.7 8.1 5.6 2.5 .7 7.3 5.5 1.8 .7 7.3 4.9 2.4 .7 7.7 5.4 2.3 .7 7.4 5.5 1.9 .7 7.3 5.3 2.0 .7 7.2 5.3 1.9 .7 7.3 5.2 2.1 .7 7.0 5.1 1.9
.6 7.6 5.4 2.2
.2 80 34 .2 76 26 .2 67 30 .3 58 30 .3 93 39 .2 64 16 .2 61 35 .2 58 20 .2 55 26 .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. 1
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. 9
10 10 10 10 10 10 10 10 10
r
OTl/O
252
9 bo
ANIMAL NUMBER
Appendix 5
Individual Clinical Chemistry Data
Females
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
GLU MG/DL
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL MG/DL
TRIG MG/DL
Covance 6329-225 3M T-6314.1
Group: 3
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030
MEAN S.D. N
Group: 4
C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050
MEAN S.D. N
Dose Level : 30
102 10 116 13 113 12
95 12 111 13
94 12 105 10 123 11 117 13
99 15
108 10.0 10
12 1. 5
10
Dose Level : 100
89 12 98 15 75 13 96 12 105 11 90 15 84 14 117 15 89 15 104 13
95 12.0 10
14 1.5
10
Dosage Uni t : 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 .6 7.5 .6 7.5 .6 7.5 .6 6.8 .6 6.6 .8 7.1 .7 8.0 .6 7.0 .7 7.3
5.4 5.5 5.4 5.4 5.0 4.7 5.4 5.7 5.4 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 .2 .2 .2 .2 .2 .2 .2 .2 .1
.2 .03 10
.2 .2 .2 .2 .2 .2 .2 .2 .2 .2
.2 .00 10
62 52 75 73 69 53 76 53 58 71
64 9.7
10
46 100
43 86 50 38 48 37 39 45
53 21.7 10
28 30 25 37 21 25 43 26 28 21
28 6
10
24 48 17 34 26 24 20 21 17 26
26 9
10
253
0 1 :: o
ANIMAL NUMBER
Appendix 5
Individual Clinical Chemistry Data
Females
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
AST/SGOT ALT/SGPT
IU/L
IU/L
GGT IU/L
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990
MEAN S.D. N
Group: 2
C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010
MEAN S.D. N
Dose L e v e l :! 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
Covance 6329-225 3M T-6314.1
254
ANIMAL NUMBER
Appendix 5
Individual Clinical Chemistry Data
Females
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
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
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
5.8 .52 10
107 102 103 103 104 107 104 104 103 107
104 1
10
107 101 108 103 107 107 104 109 109 106
106 2
10
oU J
255
o
m
Appendix 5
Individual Clinical Chemistry Data
Males
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
PCOAO IU/G
Group : 1
C95911 C95912 C95913 C95914 C95915
MEAN S.D. N
Group : 2
C95931 C95932 C95933 C95934 C95935
MEAN S.D. N
Group : 3
C95951 C95952 C95953 C95954 C95955
MEAN S.D. N
Dose Level
11 9
13 10 18
12 3.6 5
Dose Level
12 15 13 11 16
13 2.1 5
Dose Level 30
14 7 2 8 9
8 4.3 5
Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS Dosage Unit: ppm MeFOS
Covance 6329-225 3M T-6314.1
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
O tn
257
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 I/G
Covance 6329-225 3M T-6314.1
Group : 1
Dose Level: 0
Dosage Unit: ppm MeFOS
C95991 C95992 C95993 C95994 C95995
6 9 3 7 9
MEAN S.D. N
7 2.5 5
Group : 2
Dose Level: 3
Dosage Unit: ppm MeFOS
C96011 C96012 C96013 C96014 C96015
6 3 9 3 2
MEAN S.D. N
5 2.9 5
Group : 3
Dose Level: 30
Dosage Unit: ppm MeFOS
C96031 C96032 C96033 C96034 C96035
7 6 5 5 13
MEAN
7
S.D.
3.3
N5
O
C/
CO
258
Appendix 5
Individual Clinical Chemistry Data
Females
Week 5
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
PCOAO IU/G
Group : 4
C96051 C96052 C96053 C96054 C96055
MEAN S.D. N
Dose Level: 100
8 9 11 10 15
11 2.7 5
Dosage Unit: ppm MeFOS
Covance 6329-225 3M T-6314.1
O (/! it*
259
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 : 1
Dose Level: 0
Dosage Unit: ppm MeFOS
C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920
MEAN S.D. N
125 12 .8 7.5 4.8 2.7
123 13 .8 7.5 4.6 2.9
107 14 .8 7.3 4.7 2.6
120 17 .8 6.8 4.5 2.3
106 11 .7 6.8 4.6 2.2
120 11 .7 7.6 5.1 2.5
106 14
.8 6.7 4.4 2.3
115 13 .8 7.3 4.9 2.4
126 10 .7 7.5 5.1 2.4
125 11 .7 7.2 4.7 2.5
117 13 .8 7.2 4.7 2.5
8.2
2. 1
.05
.34
.24
.21
10 10 10 10 10 10
.2 54 76 .1 71 34 .2 69 61 .2 80 61 .1 53 64 .2 100 111 .1 54 53 .1 82 50 .1 64 43 .2 60 39
.2 69 59
.05
15..2
22
10 10 10
Group : 2
Dose Level: 3
Dosage Unit: ppm MeFOS
C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939
115 10
.7 6.9 4.8 2.1
.2 37 44
129 15
.8 6.7 4.6 2.1
.1 44 83
121 15
.7 6.5 4.4 2.1
.1 87 42
126 10
.7 7.1 4.6 2.5
.1 60 41
118 13
.8 7.1 4.7 2.4
.2 41 43
125 14
.8 7.3 4.9 2.4
.2 56 84
115 12
.8 7.1 5.0 2.1
.1 38 75
105 10
.7 6.8 4.5 2.3
.1 61
89
109 10
.7 7.6 4.9 2.7
.1 69 28
126 13
.7 6.6 4.5 2.1
.1 79 36
MEAN S.D. N *>
119 12
.7 7.0 4.7 2.3
.1 57 56
7.9
2. 1
.05
.34
.20
.21
.05
17. 4
23
10 10 10 10 10 10 10 10 10
o
Ul
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 Uni t : ppm MeFOS
C95961
131 16 .7 7.3 5.1 2.2 .2 13 15
C95962
121 13 .7 6.5 4.9 1.6 .3 11 12
C95963
153 16 .8 7.5 5.6 1.9 .2 39 27
C95964
140 16 .8 7.4 5.6 1.8 .2 37 21
C95965
120 14 .7 7.3 5.3 2.0 .2 25 18
C95967
123 15
.7 7.5 5.3 2.2
.2 46 21
C95968
120 13 .8 7.7 5.2 2.5 .2 31 16
C95969
123 17
.7 6.8 4.7 2.1
.2 15
9
i*>
C95977
116 14 .7 6.7 4.9 1.8 .1 19 19
r>
C95980
131 15 .7 7.1 5.1 2.0 .2 20 14
b*
MEAN
128 15
.7 7.2 5.2 2.0
.2 26
17
O
S.D. N
11.3 1.4 .05 .39 .29 .26 .05 12.1 5.2 10 10 10 10 10 10 10 10 10
(A
261
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
Covance 6329-225 3M T-6314.1
Group : 1
Dose Level :: 0
Dosage Unit: ppm MeFOS
C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920
101 44 95 38 87 35
107 42 110 39
87 38 109 47
59 29 68 35 70 36
3 11.3 7.8 154 6.2 113 3 10.6 6.0 148 6.4 107 1 10.8 7.6 152 6.5 110 0 10.3 7.0 149 6.1 109 3 9.9 6.2 147 6.1 106 3 11.3 6.2 146 5.7 102 3 10.2 6.2 148 5.9 107 2 11.2 6.2 150 5.9 109 0 11.0 6.4 151 6.3 111 1 10.6 6.2 151 5.5 113
MEAN S.D. N
89 18.4 10
38 5.1
10
2 1.3 10
10.7 .49 10
6.6 .65 10
150 2. 5
10
6.1 .31 10
109 3
10
Group : 2
Dose Level:: 3
Dosage Unit: ppm MeFOS
C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939
86 49 80 44 83 36 95 43 94 50
69 39 91 44 100 30 75 34 92 39
2 10.3 6.7 150 5.9 111 2 10.8 6.7 151 6.2 110 2 10.3 6.7 146 6.1 105 3 10.2 6.2 148 6.1 106 3 10.6 6.1 152 6.3 111 2 10.9 6.9 148 6.1 105 3 10.8 6.5 150 6.4 110 3 10.3 6.1 147 5.5 105 3 10.7 6.4 152 5.8 112 1 10.7 6.7 152 6.4 112
MEAN
86 41
2 10.6 6.5 150 6.1 109
S.D.
9.7 6.4
.7 .26
.29
2.2 .28
3
O N 10 10 10 10 10 10 10 10
*\I
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
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
96 44 111 45
82 31 74 38 75 36 84 45 126 49 94 34 88 28 78 34
3 10.3 6.3 150 6.5 112 1 10.3 6.2 151 6.4 111
3 10.0 6.8 149 6.1 109 3 10.6 7.5 150 6.5 111 1 10.1 6.4 145 5.4 104 3 10.6 7.2 150 6.3 105 0 9.2 5.5 145 5.8 104 2 10.3 6.8 150 6.1 108 3 10.4 6.0 151 6.2 110 4 10.4 6.6 150 6.5 110
MEAN S.D, N
91 16.7 10
38 7.0
10
2 1.3 10
10.2 .40 10
6.5 .58 10
149 2.2
10
6.2 .36 10
108 3
10
Group: 4
Dose Level: 100
Dosage Unit: ppm MeFOS
C95961
73 46
3 10.6 6.6 152 6.9 112
C95962
83 48
2 10.0 6.8 150 6.5 108
C95963
63 33
2 10.9 7.1 154 6.4 112
rs
C95964 C95965
100 64 99 65
1 10.6 7.3 152 7.0 112 3 10.6 7.3 153 6.7 109
'Ir *
C95967
95 57
2 10.6 6.7 147 5.6 102
C95968
108 70
3 10.5 7.3 147 6.6 103
C95969
86 36
2 10.0 6.2 147 6.3 108
Q C95977
99 70
1 10.1 6.4 150 5.6 111
2( A
C95980
102 108
10.5 7.0 151 6.5 112
C3 MEAN
91 60
2 10.4 6.9 150 6.4 109
S.D,
14.3
21.6
.7 .30
.39
2.6 .48
3
N 10 10 10 10 10 10 10 10
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. 8
10 10 10
.1 52 19 .2 57 24
.2 78 32 .1 69 34 .1 70 34 .2 67 92 .2 73 28 .2 76 45 .1 80 34
.2 69 38
.05
9..4
21. 5
999
o
m
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 Unit: 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 .2 .2 .2 .2 .2 .2 .2 .2 .1
.2 .03 10
.2 .2 .2 .2 .2 .2 .2 .2 .2 .2
.2 .00 10
57 58 74 66 75 59 78 78 74 86
70 9. 9
10
84 65 45 56 50 30 35 34 42 71
51 17..7 10
35 30 29 36 26 32 69 26 44 37
36 12 10
32 29 26 23 18 21 25 22 22 28
25 4
10
OSOTO 5
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
Covance 6329-225 3M T-6314.1
Group: 1
Dose Level :: 0
Dosage Unit: ppm MeFOS
C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000
MEAN S.D. N
74 92 79 77 79 101 88 78 75 99
84 10.1 10
27 34 31 31 35 35 48 37 30 33
34 5.7
10
4 3 2 3 1 3 1 3 1 4
2 1.2 10
11.0 10.9 11.0 10.7 11.0 11.1 11.7 11.2 10.9 10.5
11.0 .32 10
4.2 4.2 4.6 4.4 5.0 5.6 5.4 5.0 5.5 4.4
4.8 .54 10
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
113 113 110 114 110 107 112 113 111 106
111 2
10
Group: 2
Dose Level :: 3
Dosage Unit: ppm MeFOS
C96001 C96002
C96003 C96006 C96007 C96008 C96010 C96019 C96020
91 100 190
89 101
81 101
94 114
36 31 96 30 44 30 42 35 40
1 10.7 5.3 150 6.0 115 1 10.6 4.3 149 5.8 108 3 10.6 4.3 150 ' 5.9 111 3 10.4 5.0 147 5.8 109 3 11.7 7.3 159 7.7 114 4 10.7 4.3 147 5.1 105 3 10.5 5.0 149 6.2 110 1 11.1 5.3 150 6.1 114 4 11.1 5.4 151 6.4 113
MEAN
107 43
3 10.8 5.1 150 6.1 111
S.D.
32.6
20.7
1.2 .41
.93
3.6 .70
3
O N 99999999
o
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
Covance 6329-225 3M T-6314.1
Group: 3
Dose Level: 30
Dosage Unit: ppm MeFOS
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040
84 30 81 29 88 30 65 22 87 35 76 29 106 34 78 33 130 34 485 364
6 11.2 6.0 153 6.9 112 4 11.2 6.2 156 6.7 113 1 11.0 4.3 147 5.9 105 1 11.0 5.6 150 5.6 111 2 11.6 6.5 152 6.2 109 2 10.6 4.7 148 5.3 109 4 10.9 5.2 149 6.4 106 2 10.9 6.5 151 6.3 110 3 10.9 5.3 149 5.8 107 5 11.1 5.9 151 6.5 111
MEAN S.D. N
128 126.7
10
64 105.5
10
3 1.7 10
11.0 .26 10
5.6 .74 10
151 2..6
10
6.2 .50 10
109 2
10
Group: 4
Dose Level: 100
Dosage Unit: ppm MeFOS
C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060
95 30 75 31 70 33 78 41 79 32 79 31 91 48 66 31 90 38 82 41
3 11.5 5.3 150 6.0 110 3 11.3 5.6 154 6.0 111 5 10.6 5.9 147 5.5 104 3 11.0 5.8 151 6.2 110 1 10.9 6.8 149 5.8 108 2 10.7 4.8 151 5.1 110 3 10.9 6.3 155 6.5 112 2 10.8 5.4 149 5.4 110 3 10.8 3.6 147 5.4 105 3 10.9 4.7 152 5.5 114
QTij )
o
MEAN S.D.
80 ?.3
36 6.1
3 10.9 1.0 .27
5.4 .90
150 2..7
5.7 .43
109 3
h i N 10 10 10 10 10 10 10 10
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 Lei
4 11 11 10 11 12
8 10 10
8 11 11 13
8 7
10 2
15
Dosage Unit: ppm MeFOS
Covance 6329-225 3M T-6314.1
o
O CO
268
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
Covance 6329-225 3M T-6314.1
Group : 2
C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95936 C95937 C95938 C95939 C95940
MEAN S.D. N
Dose Level: 3
10 10
7 11 10 11 12 12 12
12 10
4 9 8 4
9 2.7 15
Dosage Unit: ppm MeFOS
***
o
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
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
SOTO J
Cl
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 Le-
17 11 12 11
5 12 38 13 19 22 22
5 12 15 16
15 8
15
Dosage Unit: ppm MeFOS
Covance 6329-225 3M T-6314.1
o
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
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
coios
-a
272
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
o
o
cs
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 30
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
90 TOO
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
r*
O&OTL-
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
Dossaaggie 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
Dossaaggie 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
TGTOO
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
Covance 6329-225 3M T-6314.1
Group : 3
Dose Level:: 30
Dossaaggie Unit: ppm MeFOS
C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960
9.1 21.1 17.1
3.5 10.4 13.6 47.5
6.0 1.3 8.0
a
1.022 1.013 1.021 1.037 1.024 1.014 1.002 1.037 1.060 1.030
7.5 6.5 7.0 7.0 7.0 7.0 6.0 6.5 6.5 7.0
MEAN S.D. N
13.8 13.29
10
1.026 .0162 10
6.8 .42 10
Group : 4
Dose L e v e l :; 100
Dossaaggie Unit: p p m MeFOS
C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980
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
7.0 6.5 6.5 6.5 6.5 7.0 6.5 7.0 6.5 6.5
Th )
MEAN S.D. N
21.0 16.52
10
1.024 .0148 10
6.6 .24 10
a
a Sample was overflowing at the time of collection.
277
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
30 30 30 30 30 30 30 30 30 10
Level : 3
_
-
-
+ + +++ ++
-
+++ + + +
Dosage Unit:
_ -
-
ppm MeFOS
_
-
-
-
++
-
-
Dosage Unit: ppm MeFOS
__
+-
---
--
++ ++ ++ -
--
--
-
Covance 6329-225 3M T-6314.1
'-r*
o ts>
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: 100
10 _ 30 10 30 30 30 10 10 10 10 -
Dosage Unit: ppm MeFOS
+_
--
+-
--
--
+-
--
++ ++-
-
-
_
++
-
++ + +
-
-
+++ +
Dosage Unit:
_
-
-
ppm MeFOS
-
+++
-
_
-
-
_ -
Covance 6329-225 3M T-6314.1
**1
P o
Y
Vj
279
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 PER HPF
WBC PER HPF
EPITH PER HPF
BACT PER HPF
CASTS PER LPF
CRYSTALS PER LPF1
URINE APP1
COMMENTS
Group: 1
C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920
Group: 2
C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939
Dose Level: 0
00 11 00 00 00 00 00 41 01 00
Dose Level: 3
01 00 00 00 01 00 01 00 00 01
Dosage Unit: ppm MeFOS
030 130 130 120 130 120 010 130 120 120
Dosage Unit: ppm MeFOS
12 0 120 120 120 020 130 120 1 30 1 30 120
1B4D 4D 4D 2B4D 0 4D 3D 4D 2B1D 4D
4D 3D 3D 4D 3D 4D 1B4D 4D 4D 2D
BJ BJ BJ BK BJ BJ CJ BJ BJ CJ
BKM BJ BJ BJ BJ BJ BJ BJ BJ BJ
P PQ PQ PQ P PQ
-
PQ QR Q
PQ Q PQ p p Q Q PQ PQ Q
Covance 6329-225 3M T-6314.1
("S
0 J 01
280
Tr-p*' o
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 PER HPF
WBC PER HPF
EPITH PER HPF
BACT PER HPF
CASTS PER LPF
CRYSTALS PER LPF1
URINE APPl
COMMENTS
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 L e v e l : 30
00 0i 0i 00 00 00 01 01 00 00
Dose Level: 100
01 00 00 00 00 20 00 40 00 01
Dosage Unit: ppm MeFOS
030 110 020 020 120 1 20 010 1 30 110 120
Dosage Unit: ppm MeFOS
010 120 120 110 1 30 120 130 000 120 120
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
Covance 6329-225 3M T-6314.1
Group : 1
Dose Level:: 0
Dosage Unit: ppm MeFOS
C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000
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
6.5 7.0 7.0 6.5 6.5 6.5 6.5 7.0 6.5 7.0
MEAN S.D. N
17.0 14.13
10
1.016 .0112 10
6.7
.26 10
Group : 2
Dose L e v e l :: 3
Dosage Unit: ppm MeFOS
C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020
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
6.5 6.5 6.5 7.5 6.5 7.5 6.5 6.5 7.0
MEAN S.D. N
11.4 10.11
9
1.020 .0102 9
6.8 .44 9
Pi
o
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
Covance 6329-225 3M T-6314.1
Group : 3
Dose Level :: 30
Dosage Unit: ppm MeFOS
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040
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
7.0 6.5 6.5 7.0 6.5 6.5 7.0 6.5 7.0 7.0
MEAN S.D. N
16.7 14.62
10
1.016 .0084 10
6.8
.26 10
Group : 4
Dose Level :: 100
Dosage Unit: ppm MeFOS
C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060
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
6.5 6.5 6.5 6.5 6.5 6.5 6.5 6.5 7.0 7.0
MEAN S.D.
15.7 12.05
1.019 .0113
6.6 .21
N 10 10 10
03
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
r*
O
a
284
Appendix 5
Individual Clinical Urinalysis Data
Females
Week 14
13-WEEK d i e t a r y t o x i c i t y s t u d y w i t h n -m e t h y l p e r f l u o r o o c t a n e s u l f o n a m i d o ETHANOL (N-MEFOSE, T-6314) IN RATS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET
U BILI
U BLOOD UROBILI
Group: 3
C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040
Group : 4
C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060
Dose
10 0 10 0 10 10 10 10 10 0
Level:
_
-
30
Dose Level: 100
10 _ 30 10 10 010 10 10 00-
Dosage Unit: ppm MeFOS
_ _
---
---
-_ -
--
--
-
- --
-- -
-----
Dosage Unit: ppm MeFOS
___
---
---
---
--
--
-
---
---
---
---
_ _
_
-
Covance 6329-225 3M T-6314.1
US
O
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 PER HPF
WBC PER HPF
EPITH PER HPF
BACT PER HPF
CASTS PER LPF
CRYSTALS PER LPF1
URINE APPI
COMMENTS
Group : 1
Dose Level: 0
Dosage Unit:: ppm MeFOS
C95983
0
1
1
2
0
2D BJ _
C95984
0
0
1
1
0
ID AJ -
C95985
0
0
0
1
0
0
AJ -
C95986
0
1
1
1
0
0
AJ -
C95987
0
1
1
2
0
4D BJ P
C95988
0
0
1
3
0
4D AJ -
C95990
0
0
1
1
0
2D BJ P
C95996
0
0
0
1
0
2D AJ -
C95997
0
0
1
3
0
4D BJ P
C96000
0
0
1
1
0
4D BJ -
Group : 2
Dose Level: 3
Dosage unit:: ppm MeFOS
C96001
0
0
1
1
0
4D BJ P
C96002
0
0
1
2
0
4D BJ P
C96003
0
0
1
3
0
4D BJ P
C96006
0
1
1
2
0
4D BJ P
C96007
0
0
0
1
0
0
AJ -
C9608
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
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 PER HPF
WBC PER HPF
EPITH PER HPF
BACT PER HPF
CASTS PER LPF
CRYSTALS PER LPF1
URINE APPI
COMMENTS
Group: 3
Dose Level : 30
Dosage Unit:; ppm MeFOS
C96021
0
1
1
2
0
4D BJ P
C96022
0
0
0
1
0
3D BJ -
C96023
0
0
1
1
0
0
AJ -
C96024
1
0
1
1
0
0
AJ -
C96025
0
0
1
1
0
0
BJ -
C96026
0
0
1
1
0
IB AJ -
C96027
0
1
1
2
0
4D BJ P
C96030
0
1
1
1
0
0
BJ -
C96038
0
0
1
2
0
0
BJ -
C96040
0
0
1
1
0
0
BJ P
Group : 4
Dose Level : 100
Dosage Unit:: ppm MeFOS
C96042
0
0
1
1
0
2D BJ -
C96044
0
1
0
2
0
ID BJ -
C96045
0
0
1
2
0
0
AJ -
C96046
0
1
1
2
0
4D BJ P
C96047
0
1
1
1
0
IB AJ -
C96048
0
0
1
1
0
0
BJ P
C96049
0
0
1
2
0
4D BJ P
C96050
0
1
1
2
0
4D BJ -
C96056
0
0
0
2
0
0
AJ -
C96060
0
0
1
1
0
0
AJ -
Covance 6329-225 3M T-6314.1
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3MT-6314.1
010S 3
288
APPENDIX 6 individual Anatomie Pathology Data
Covance 6329-225 3M T-6314,1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 1
ANIMAL NUMBER: C95901
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
477.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:16
PROSECTOR: LAURIE J. SCHULLER
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0507 2.1637 3.6235 13.2353
.6399 3.0353
.3522 .0353
.0106 % .4528 % .7582 % 2.7695 % .1339 % .6351 % .0737 % .0074 %
.0234 1.0000 1.6747 6.1170
.2957 1.4028
.1628 .0163
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
HEART (HT) : -DEGENERATION/NECROSIS, -MINIMAL
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
PANCREAS (PA) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
o
CS
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)
290
APPENDIX 6 Individual Anatomie Pathology Data
Covance 6329-225 3M t -6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 3
ANIMAL NUMBER: C95902
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
500.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:38
PROSECTOR: JODI THIEREN
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
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
rv - - -
P
--
--
--
O
LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL
KIDNEY (KD) : -MINERALIZATION, TUBULAR,-MINIMAL
THYMUS (TH) :
-HEMORRHAGE,-MINIMAL LN, MANDIBULAR (MN) :
-HEMORRHAGE,-SLIGHT PROSTATE (PR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
c?>
291
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 4
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
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD) , HEART (HT) ,MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV),
TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL(SM), NERVE, SCIATIC (SN), SPLEEN (SP) , LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , A U DITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
'f V
O
292
APPENDIX 6 Individual Anatomie Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 5
ANIMAL NUMBER: C95903
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
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 STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0585 2.1393 3.4896 13.3362
.8041 3.5494
.2730 .0280
.0121 % .4431 % .7228 % 2.7623 % .1665 % .7352 % .0565 % .0058 %
.0273 1.0000 1.6312 6.2339
.3759 1.6591
.1276 .0131
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LN, MANDIBULAR (MN) : -MOTTLED; BILATERAL: RED AND TAN
<> GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
C 00
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
APPENDIX 6 individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 6
ANIMAL NUMBER: C95903
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:!: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 482.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:07
PROSECTOR: KIMBERLY DURLAND
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SAL IV G L , 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
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 7
ANIMAL NUMBER: C95904
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
502.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:07
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
O R GA N 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
O B S E R V A T I C )N S
HISTOPATHOLOGY
THYROID (TY) : > N O T E :>TRIM COMMENT:
PARATHYROID (PT) : > N O T E :>TRIM COMMENT:
ONE MISSING AT TIME OF TRIMMING 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
o LO
o
295
APPENDIX 6 Individual Anatomic Pathology Data
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
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
" t > pk
o
296
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 9
ANIMAL NUMBER: C95905
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
477.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:03
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (*)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STA TUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0413 2.1962 3.2242 13.4331
.8531 3.1958
.3319 .0209
.0086 % .4596 % .6748 % 2.8114 % .1785 % .6689 % .0695 % .0044 %
.0188 1.0000 1.4681 6.1165
.3884 1.4551
.1511 .0095
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 10
ANIMAL NUMBER: C95905
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
477.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:03
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT), MUSCLE, SKELETAL (SM). NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
r> o
Y*
a
u
298
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 11
ANIMAL NUMBER: C95906
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH; 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
532.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:06
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID /PARATHYR
(TT)
.0596 2.2070 3.6715 17.6850
.9226 3.5489
.2941 .0273
.0112 % .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
o
(.0 ht*
299
APPENDIX 6 Individual Anatomic Pathology Data
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:I: 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, NO N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
p
300
APPENDIX 6 Individual Anatomic Pathology Data
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
SG f.l'i-- >
301
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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 (J E ) , 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)
302
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 15
ANIMAL NUMBER: C95908
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
505.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:36
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS <TH) T H Y R O I D / PA R A T H Y R
(T T )
.0571 2.1256 3.4921 13.0677
.8254 3.3149
.5078 .0193
.0113 % .4209 % .6915 % 2.5877 % .1634 % .6564 % .1006 % .0038 %
.0269 1.0000 1.6429 6.1478
.3883 1.5595
.2389 .0091
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL
PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
i*S
GOTO
303
APPENDIX 6 Individual Anatomic Pathology Data
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
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 7:36
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP : 1
SACRIFICE STATUS:
DEATH:I: 93
STUDY WEEK OF DEATH: 14
PROSECTOR: JOHN S. HALFORD
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 505.0
RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER
GRAMS
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), S A L I V G L , 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), S A L I V G L , 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
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) :
'w
-BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS
--_
----------
LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATO C Y T E ,-MINIMAL
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
HARDERIAN GLAND (HG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
---- -- ---- -- -- ---- ---- -- ---- -
GOT
305
APPENDIX 6 Individual Anatomic Pathology Data
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 (J E ) , 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)
O
P
306
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 19
ANIMAL NUMBER: C95910
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
573.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:54
PROSECTOR: NANCY DIEDRICH
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
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)
.0412 2.2483 4.4547 16.2577
.8328 3.6513
.5244 .0345
.0072 % .3918 % .7764 % 2.8333 % .1451 % .6363 % .0914 %
.0060 %
.0183 1.0000 1.9814 7.2311
.3704 1.6240
.2332 .0153
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
i~N GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
pvX
LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL -MINERALIZATION, V A S C U L A R ,-MINIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
KIDNEY (KD) : -BASOPHILIC TUBULES, C O R T E X ,-MINIMAL
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PROSTATE (PR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
Q
N
307
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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, N O N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , 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)
COTIA'5^
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:
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
DATE AND TIME OF NECROPSY: 10/01/98 11:59
PROSECTOR: TONY HANFELD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 324.5 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) 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, N O N G L (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , 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)
O 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 (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC)
r>
'r *
0 01
310
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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 S TA T U S
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 (J E ) , 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)
Wk
o
Cf>
311
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 24
ANIMAL NUMBER: C95914
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 346.2 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:36
PROSECTOR: MATTHEW AXTMAN
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
11.8655 -----------------------------
----------------------
3.4274 -----------------------------
%
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) . BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC)
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 (J E ) , 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)
o 00
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
OBSERVATION S
HISTOPATHOLOGY
KIDNEY (KD) : -LARGE PELVIS(ES); RIGHT
THYMUS (TH) : -RED FOCUS(I)/AREA(S); DIFFUSE: MULTIPLE DARK RED AREAS, TO 3 X 2 MM
STOMACH, GL (ST) : >NOTE:>TRIMMING COMMENT: STOMACH NOT FOUND IN WET TISSUE
STOMACH, NONGL (SU) : >NOTE:>TRIMMING COMMENT: STOMACH NOT FOUND IN WET TISSUE
UP
DUODENUM (DU) : >NOTE:>TRIMMING COMMENT: DUODENUM NOT FOUND IN WET TISSUE
i"'*
LUNG (LU) : -INFLAMMATION, SUBACUTE,-MINIMAL
KIDNEY (KD) -DILATATION , PELVIC,-MINIMAL
THYMUS (TH) J -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
Va
O
W
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 WEE K 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 SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
(PR),
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR(FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY) ,PARATHYROID (PT) ,ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), JEJUNUM (JE) ,ILEUM (IL), CECUM (CE) ,COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
315
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 28
ANIMAL NUMBER: C95917
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
531.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:37
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
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 1.0000 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, V A S C U L A R ,-MINIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
THYROID (TY) :
-CYST, ULTIMOBRANCHIAL,-PRESENT RECTUM (RE) :
-PARASITISM,-PRESENT PROSTATE (PR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
f*
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 SPINAL CORD
(( SFCE)) ,,MTARRARCOHWE,AFEMUR
(FM), (TR) ,
MARROW, STERNUM (SE), BONE, STERNUM ESOPHAGUS (ES) , KIDNEY (KD) , HEART
(SB), (HT) ,
EYE (EY),BRAIN (BR), MUSCLE, SKELETAL (SM) ,
NERVE,
SPLEEN (SP), THYMUS (TH) , LN, MESENTERIC (MS), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) ,
AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE),
ILEUM (IL), CECUM (CE), COLON (CO), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG),
AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
SCIATIC(SN) ,
> /A
317
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: 30
ANIMAL NUMBER: C95918
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
494.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:58
PROSECTOR: LAURIE J. SCHULLER
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0547 2.0931 3.6402 14.9341
.7976 3.2582
.2806 .0265
.0111 % .4231 % .7358 % 3.0188 % .1612 % .6586 % .0567 % .0054 %
.0261 1.0000 1.7391 7.1349
.3811 1.5566
.1341 .0127
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
THYMUS (TH) : -RED FOCUS(I)/AREA(S); DIFFUSE: TO 3 X 2 MM
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
MULTIPLE DARK RED AREAS,
UP
LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
(" V
h*
u
318
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: 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), B RAIN (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)
f >. 14*
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
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0603 2.2555 4.1905 16.3018
.9470 3.1638
.2340 .0308
.0115 % .4305 % .7999 % 3.1116 % .1808 % .6039 % .0447 %
.0059 %
.0267 1.0000 1.8579 7.2276
.4199 1.4027
.1037 .0137
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LN, MANDIBULAR (MN) : -DIFFUSELY RED; RIGHT: DARK RED
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
HEART (HT) :
-DEGENERATION/NECROSIS ,-MINIMAL THYROID (TY) :
-CYST, ULTIMOBRANCHIAL,-PRESENT PARATHYROID (PT) :
-CYST,-PRESENT PITUITARY (PI) :
-CYST,-PRESENT LN, MANDIBULAR (MN) :
-HEMORRHAGE,-MINIMAL PROSTATE (PR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 33
ANIMAL NUMBER: C95919
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
523.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:30
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) ,MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), S A L I V G L , MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) , MARROW, FEMUR (FM) ,MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), MUSCLE, SKELETAL (SM), NERVE,SCIATIC SPLEEN (SP), THYMUS (TH) , LN, MESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP)
(SN),
\
TTO-3
CD
321
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: 34
ANIMAL NUMBER: C95920
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
514.2 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:35
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0685 2.1808 4.1319 15.1321
.8162 3.1121
.4094 .0193
.0133 % .4241 % .8036 % 2.9428 % .1587 % .6052 %
.0796 % .0038 %
.0314 1.0000 1.8947 6.9388
.3743 1.4270
.1877 .0088
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
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
TTC- )
322
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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)
r\
h* K* 00
323
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 36
ANIMAL NUMBER: C95921
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
478.4 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:11
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
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)
con
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
O B S E R V A T I C )N 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),
i*S 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)
t J4
o
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 1.0000 1.8695 6.4562
.2926 1.7042
.1557 .0057
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HI STOPATHOLOGY
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 (J E ) , 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)
h*
n
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
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0561 2.1774 3.7379 13.9536
.9245 3.5483
.3028 .0248
.0113 % .4367 % .7497 % 2.7986 % .1854 % .7117 % .0607 % .0050 %
.0258 1.0000 1.7167 6.4084
.4246 1.6296
.1391 .0114
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR),
<_*1________S_E_M_I_N_A_L__V_E_S_I_C_L_E_S__(_S_V_)_,__T_E_S_T_I_S__(_T_E_)_,__E_P_I_D_I_D_Y_M_I_D_E_S__(_E_P_)_,__T_A_I_L__(_T_I_)_____________________________________________________
-
10
327
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 40
ANIMAL NUMBER: C95925
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
468.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:10
PROSECTOR: KIMBERLY DURLAND
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT {%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0628 2.2194 3.9763 14.6970
.6523 3.1815
.2829 .0261
.0134 % .4739 % .8491 % 3.1384 % .1393 % .6794 % .0604 % .0056 %
.0283 1.0000 1.7916 6.6221
.2939 1.4335
.1275 .0118
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
STOMACH, GL (ST) : -LIGHT FOCUS(I)/AREA(S); MUCOSA, NEAR ESOPHAGEAL GROVE SINGLE WHITE, SLIGHTLY RAISED AREA, 1 MM IN DIAMETER
LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
STOMACH, GL (ST) : UNREMARKABLE
LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT
o *ry
n
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), S A L I V G L , 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)
|,Jk 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
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
ABSOLUTE ORGAN WEIGHT (GRAMS)
.0518 1.9876 2.8500 11.7726
.6868 2.7873
.3553 .0163
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
.0118 % .4531 % .6496 % 2.6835 % .1566 % .6354 % .0810 % .0037 %
ORGAN TO BRAIN WEIGHT RATIO
.0261 1.0000 1.4339 5.9230
.3455 1.4023
.1788 .0082
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)
cOil
Cl
330
APPENDIX 6 Individual Anatomic Pathology Data
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
i") l; V*
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 S T A I 7U S
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: AREA, 3 X 1 MM
GENERAL COMMENT (GC) : -BONE MARROW SMEAR' TAKEN
SINGLE DARK BROWN LINEAR
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
STOMACH, GL (ST) : -EROSION,-SLIGHT
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV> , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
331
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 44
ANIMAL NUMBER: C95928
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
486.1 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:23
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
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)
.0537 2.0720 3.6794 14.1057
.5995 3.4858
.2143 .0300
.0110 % .4262 % .7569 % 2.9018 % .1233 % .7171 % .0441 % .0062 %
.0259 1.0000 1.7758 6.8078
.2893 1.6823
.1034 .0145
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 (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN),
"5 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)
___ ___________________________________________
________________________________________________________
_________ ______
_________
___ _________________________
_ ___________ _ _________ _________ ________
*3
332
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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
ORGAN 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
OBSERVATIONS
HISTOPATHOLOGY
THYMUS (TH) : -RED FOCUS(I)/AREA(S); RIGHT LOBE:
3 MM GENERAL COMMENT (GC) :
-BONE MARROW SMEAR TAKEN
SINGLE DARK RED AREA,
6X
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT -NECROSIS, INDIVIDUAL HEPATO C Y T E ,-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) ,
Q 0 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)
co n
333
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: 46
ANIMAL NUMBER: C95930
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 484.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:59
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
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)
.0711 2.0340 3.8914 15.3859
.8442 3.4684
.4143 .0169
.0147 % .4202 % .8040 % 3.1789 % .1744 % .7166 % .0856 % .0035 %
.0350 1.0000 1.9132 7.5644
.4150 1.7052
.2037 .0083
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
KIDNEY (KD) : -LARGE PELVIS(ES); LEFT -GRANULAR MATERIAL; LEFT, WITHIN PELVIS: MULTIPLE TAN,
PINPOINT GRANULES GENERAL COMMENT (GC) :
-BONE MARROW SMEAR TAKEN
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
KIDNEY (KD) : -DILATATION, PELVIC,-SLIGHT
Y-.*J\
334
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 47
ANIMAL NUMBER: C95930
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:1: 93
STUDY W EEK OF DEATH: 14
TERMINAL BODY WEIGHT: 484.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:59
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG> , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
335
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 48
ANIMAL NUMBER: C95931
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 362.7 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:47
PROSECTOR: MATTHEW AXTMAN
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
11.8205 -----------------------------
----------------------
3.2590 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH) , LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC)
***
P P
u
p
336
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 49
ANIMAL NUMBER: C95932
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS:
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
DATE AND TIME OF NECROPSY: 10/01/98 11:42
PROSECTOR: MATTHEW AXTMAN
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 329.1 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
9.9205 -----------------------------
----------------------
3.0144 -----------------------------
%
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
tJ
to
337
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 50
ANIMAL NUMBER: C95933
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT:
341.3 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:44
PROSECTOR: TONY HANFELD
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
11.2465 -----------------------------
----------------------
3.2952 -----------------------------
%
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC)
'1^ P Q Q
338
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 51
ANIMAL NUMBER: C95934
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 317.0 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:58
PROSECTOR: WENDY CHERRY
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT {%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
9.9286 -----------------------------
----------------------
3.1321 -----------------------------
%
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA) , DUODENUM (DU) , JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO) , RECTUM (RE) , LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC)
c;
K-*
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
ANIMAL NUMBER: C95935
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 354.6 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 12:07
PROSECTOR: TONY HANFELD
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE 2IMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
11.8361 -----------------------------
----------------------
3.3379 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC)
U 1
340
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 53
ANIMAL NUMBER: C95936
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEE K OF DEATH: 14
TERMINAL BODY WEIGHT:
550.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 9:51
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
O RGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0484 2.0694 4.1177 15.6498
.7959 3.1581
.3262 .0188
.0088 % .3756 % .7474 % 2.8408 % .1445 % .5733 % .0592 % .0034 %
.0234 1.0000 1.9898 7.5625
.3846 1.5261
.1576 .0091
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; LEFT, UPPER INCISOR
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
-1
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M
O &
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)
341
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 54
ANIMAL NUMBER: C95937
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 444.5 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:10
PROSECTOR: TODD ACKER
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0662 2.2591 3.7504 16.6721
.8440 3.2365
.3431 .0289
.0149 % .5082 % .8437 % 3.7508 % .1899 % .7281 % .0772 % .0065 %
.0293 1.0000 1.6601 7.3800
.3736 1.4327
.1519 .0128
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
pk
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342
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 55
ANIMAL NUMBER: C95938
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/9S
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
497.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:59
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0579 2.1368 4.1230 16.5589
.5647 3.6229
.3002
.0272
.0116 % .4294 % .8286 % 3.3278 % .1135 % .7281 % .0603 % .0055 %
.0271 1.0000 1.9295 7.7494
.2643 1.6955
.1405 .0127
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
i" V
O
03
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 (J E ) , 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)
343
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 56
ANIMAL NUMBER: C95939
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
447.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:23
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) T H Y R O I D / PA R A T H Y R
(T T )
.0634 2.3237 3.6350 12.6033 1.1088 3.2485
.4355 .0289
.0142 % .5189 % .8117 % 2.8145 % .2476 % .7254 % .0973 % .0065 *
.0273 1.0000 1.5643 5.4238
.4772 1.3980
.1874 .0124
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP) , THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
----------------------------------------------------------------------------------------------------------------------------------------------
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344
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
ANIMAL NUMBER: C95940
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
483.1 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:10
PROSECTOR: KIMBERLY DURLAND
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0659 2.1363 4.1869 14.1874
.8620 3.8586
.2849 .0224
.0136 % .4422 % .8667 % 2.9367 % .1784 % .7987 % .0590 % .0046 %
.0308 1.0000 1.9599 6.6411
.4035 1.8062
.1334
.0105
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LN, MANDIBULAR (MN) : -DIFFUSELY RED: BILATERAL: DARK RED
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL UPPER INCISORS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
LN, MANDIBULAR (MN) : -HEMORRHAGE, -SLIGHT
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: U BONE, 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) , e HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
345
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: 58
ANIMAL NUMBER: C95941
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
411.5 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:42
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STA T U S
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0457
2.1186 3.5249 13.6671
.8387 3.2827
.3528 .0182
.0111 % .5148 % .8566 % 3.3213 % .2038 % .7977 % .0857 % .0044 %
.0216 1.0000 1.6638 6.4510
.3959 1.5495
.1665 .0086
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -FIBROSIS, CAPSULAR,-MINIMAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
(**>
H1
346
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 59
ANIMAL NUMBER: C95941
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
411.5 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:42
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM>, MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NO N G L (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , 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 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! 60
ANIMAL NUMBER: C95942
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
418.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:58
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0694 2.0705 4.1159 14.8588
.6815 3.5997
.2568 .0174
.0166 % .4945 % .9830 % 3.5488 % .1628 % .8597 % .0613 % .0042 %
.0335 1.0000 1.9879 7.1764
.3291 1.7386
.1240 .0084
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL
LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT
348
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 61
ANIMAL NUMBER: C95942
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH; 12/02/98
STUDY DAY OF DEATH:[: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 418.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:58
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU). PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), S A L I V G L , 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)
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
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
500.1 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:21
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD)
BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0531 2.1128 4.1504 19.4681
.6715 3.5995
.3527 .0275
.0106 % .4225 % .8299 % 3.8928 % .1343 % .7198 % .0705 % .0055 %
.0251 1.0000 1.9644 9.2144
.3178 1.7037
.1669 .0130
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, DIFFUSE,-MINIMAL
<r>
H4
\A
> tn
350
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 63
ANIMAL NUMBER: C95943
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:[: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 500.1 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:21
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY;
BONE, FEMUR SPINAL CORD
(FE), (SC),
MARROW, FEMUR LUNG (LU), TR
(FM), ACHEA
MARROW, (TR), ES
STERNUM OPHAGUS
(E(SSEi ), ,
BONE, LIVER
STERNUM (SB), EYE (LI), KIDNEY (KD),
(EY), HEART
BRAIN (HT),
(BR), 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 (J E ) , 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)
351
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 64
ANIMAL NUMBER: C95944
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
433.2 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:31
PROSECTOR: TODD ACKER
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0511 2.1737 3.9789 15.6049
.6847 3.4797
.2276 .0265
.0118 % .5018 % .9185 % 3.6022 % .1581 % .8033 % .0525 % .0061 %
.0235 1.0000 1.8305 7.1790
.3150 1.6008
.1047 .0122
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL:
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
DARK RED
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR,
LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT
CENTRILOBULAR,-MINIMAL
352
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: 65
ANIMAL NUMBER: C95944
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
433.2 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:31
PROSECTOR: TODD ACKER
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), S A L I V G L , 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)
ST-TT )
353
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 66
ANIMAL NUMBER: C95945
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
491.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:17
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
ABSOLUTE ORGAN WEIGHT (GRAMS)
.0502 2.1630 4.1701 17.2249
.6713 3.8878
.2839 .0216
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
.0102 % .4403 % .8488 % 3.5060 % .1366 % .7913 % .0578 % .0044 %
ORGAN TO BRAIN WEIGHT RATIO
.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
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, DIFFUSE,-MINIMAL
i~V *>
354
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 67
ANIMAL NUMBER: C95945
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
491.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:17
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
in
355
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3H T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS
PAGE: 68
ANIMAL NUMBER: C95946
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 469.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:59
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0648 2.3771 3.3029 15.7438
.7863 3.5288
.1989
.0365
.0138 % .5068 % .7042 % 3.3569 % .1677 % .7524 % .0424 % .0078 %
.0273 1.0000 1.3895 6.6231
.3308 1.4845
.0837 .0154
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
APPENDIX 6 individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 69
ANIMAL NUMBER: C95946
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 469.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:59
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, N O N G L (SU) , PANCREAS (PA) , DUODENUM (DU) , JEJUNUM (JE) , 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 Anatomie Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 70
ANIMAL NUMBER: C95947
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
449.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 9:45
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI)
SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0507 2.1942 3.2317 15.1188
.8297 3.2832
.3773 .0232
.0113 % .4877 % .7183 % 3.3605 % .1844 %
.7298 % .0839 % .0052 %
.0231 1.0000 1.4728 6.8903
.3781
1.4963 .1720 .0106
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
THYMUS (TH) : -RED FOCUS(I)/AREA(S); DIFFUSE: MULTIPLE DARK RED PINPOINT FOCI
LN, MANDIBULAR <MN) : -MOTTLED; BILATERAL: DARK RED AND TAN
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL
j CT
U
358
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 71
ANIMAL NUMBER: C95947
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
449.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 9:45
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR) , ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORT E X (AC), ADRENAL, MEDULLA (MA) , 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)
Cl
359
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-VJEEK DIETARY TOXICITY STUDY W ITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE; 72
ANIMAL NUMBER: C95948
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
476.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 9:44
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
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)
.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
C/
CA
360
APPENDIX 6 Individual Anatomie Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 73
ANIMAL NUMBER: C95948
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:[: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 476.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 9:44
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI). KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, COR T E X (AC), ADRENAL, MEDULLA (MA), 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)
95r<
361
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFUUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 74
ANIMAL NUMBER: C95949
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
421.1 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:44
PROSECTOR: JILL PAUS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
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
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 75
ANIMAL NUMBER: C95949
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:1: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 421.1 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:44
PROSECTOR: JILL PAUS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
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, N O N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) . PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), STOMACH, GL (ST), STOMACH, NONGL (SU)
363
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 76
ANIMAL NUMBER: C95950
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
467.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:29
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
O R GAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0593 2.2213 3.8346 15.5750
.6608 3.4323
.2306 .0259
.0127 % .4750 % .8201 % 3.3308 % .1413 % .7340 % .0493 % .0055 %
.0267 1.0000 1.7263 7.0117
.2975 1.5452
.1038 .0117
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
THYMUS (TH) : -RED FOCUS(I)/AREA(S); BOTH UP TO 5 MM IN DIAMETER
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LOBES:
MULTIPLE
DARK
RED
AREAS,
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
THYMUS (TH) : -HEMORRHAGE,-SLIGHT -INVOLUTION,-MINIMAL
j
364
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 77
ANIMAL NUMBER: C95950
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
467.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:29
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM [SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
<75
O
365
APPENDIX 6 individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 78
ANIMAL NUMBER: C95951
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 381.8 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 12:06
PROSECTOR: WENDY CHERRY
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
13.6836 -----------------------------
----------------------
3.5840 % ------------------- :----------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC)
366
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 79
ANIMAL NUMBER: C95952
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS:
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
DATE AND TIME OF NECROPSY: 10/01/98 11:25
PROSECTOR: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 316.5 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
11.6980 -----------------------------
----------------------
3.6961 -----------------------------
%
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR <MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE) , EPIDIDYMIDES (EP) , TAIL (TI) , GENERAL COMMENT (GC)
a to
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
ANIMAL NUMBER: C95953
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 326.4 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:13
PROSECTOR: TONY HANFELD
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI)
SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
11.6552
-----------------------------
----------------------
3.5708 %
-----------------------------
-----------------------------
-----------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN
NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC)
r>
O
U
368
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 81
ANIMAL NUMBER: C95954
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT:
365.4 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:38
PROSECTOR: TONY HANFELD
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
13.5081 -----------------------------
----------------------
3.6968 -----------------------------
%
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN> , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NO N G L (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , 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)
'rr* h*
s
369
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 82
ANIMAL NUMBER: C95955
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS:
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
DATE AND TIME OF NECROPSY: 10/01/98 11:55
PROSECTOR: TONY HANFELD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 346.9 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
15.0803 -----------------------------
----------------------
4.3472 % -----------------------------
---------------------------------------------------------
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, N O N G L (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC)
r>
a Cfl
370
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 83
ANIMAL NUMBER: C95956
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
523.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:27
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0526 2.1420 3.8586 17.4646
.7985 2.7847
.3131 .0268
.0101 % .4093 % .7374 % 3.3374 % .1526 % .5321 % .0598 % .0051 %
.0246 1.0000 1.8014 8.1534
.3728 1.3000
.1462 .0125
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MINIMAL
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
Qj m
371
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 84
ANIMAL NUMBER: C95956
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
523.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:27
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP) , THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU)
372
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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 M I D Z O N A L ,MINIMAL
f" 5
{? )
03
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: 86
ANIMAL NUMBER: C95957
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:I: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 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 (J E ) , 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)
rs 374
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: 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
0Tly3
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:I: 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
Vi
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 (J E ) , 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)
` W*
P P
vJ
CO
378
APPENDIX 6 Individual Anatomie Pathology Data
Covance 6329-225 3M T-6314,1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 91
ANIMAL NUMBER: C95960
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
449.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:43
PROSECTOR: MICHELE 2IMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0760 2.1953 3.8855 16.2467
.6429 3.8243
.1769 .0243
.0169 % .4883 % .8642 % 3.6136 % .1430 % .8506 % .0393 % .0054 %
.0346 1.0000 1.7699 7.4007
.2929 1.7420
.0806 .0111
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
THYMUS (TH) : -RED FOCUS(I)/AREA(S); BOTH PINPOINT FOCI
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LOBES:
MULTIPLE
DARK RED
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL
THYMUS (TH) : -HEMORRHAGE,-SLIGHT
\Z
379
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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)
rs Ui
380
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
a, 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
`J
381
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: 94
ANIMAL NUMBER: C95961
SEX: MALE
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 11:53
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 4
SACRIFICE STATUS:
D E A T H :1: 93
S T U D Y W E E K OF DEATH: 14
P R O S E C T O R : L A U R I E J. S C H U L L E R
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE
TERMINAL BODY WEIGHT:
483.1 GRAMS
R E C O R D E R : T E R R I L. W I L L I A M S
WEIGHER: TONY HANFELD
THE
FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, F E M U R (FE) ,M A R R O W , F E M U R (FM) , M A R R O W , S T E R N U M (SE) , B ONE, S T E R N U M (SB), E Y E (EY) , B R A I N (BR) , S P I N A L C O R D (SC), L U N G ( L U ) , T R A C H E A ( T R ) , E S O P H A G U S ( E S ) , K I D N E Y ( K D ) , H E A R T ( H T ) ,MUSCLE, S K E L E T A L ( S M ) , NERVE, S C I A T I C (SN), S P L E E N (SP), T H Y M U S ( T H ) , LN, M E S E N T E R I C (MS), T H Y R O I D (TY), P A R A T H Y R O I D (PT ) , ADRENAL, C O R T E X (AC), A DRENAL, M E D U L L A ( MA), A O R T A (AO), P I T U I T A R Y (PI), STOMACH, G L (ST), STOMACH, N O N G L ( SU), P A N C R E A S (PA), D U O D E N U M (DU), J E J U N U M (JE) , I L E U M (IL) , C E C U M (CE) , C O L O N (CO), R E C T U M (RE), S A L I V G L , M A N D I B (SG) , H A R D E R I A N G L A N D ( H G ) , A U D I T O R Y S E B G L (AS), S K I N ( S K ) , U R I N A R Y B L A D D E R ( U B ) , P R O S T A T E (PR), S E M I N A L V E S I C L E S ( S V ) , T E S T I S ( T E ) , E P I D I D Y M I D E S ( E P ) , T A I L (TI)
THE
FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, F E M U R (FE) ,M A R R O W , F E M U R (FM) , M A R R O W , S T E R N U M (SE) , BONE, S T E R N U M (SB), E Y E (EY) , B R A I N (BR) , S P I N A L C O R D (SC), T R A C H E A ( TR), E S O P H A G U S (ES), K I D N E Y ( K D ) , H E A R T ( H T ) , MUSCLE, S K E L E T A L ( S M ) , NERVE, S C I A T I C ( S N ) , S P L E E N (SP), LN, M E S E N T E R I C (MS), P A R A T H Y R O I D (PT) , A D R E N A L , C O R T E X (AC), A D R E N A L , M E D U L L A (MA) , A O R T A (AO), P I T U I T A R Y (PI), S T O M A C H , G L (ST), S T O M A C H , N O N G L ( S U ) , P A N C R E A S (PA), D U O D E N U M (DU), J E J U N U M (J E ) , I L E U M ( I L ) , C E C U M (CE) , C O L O N (CO), R E C T U M (RE), S A L I V GL, M A N D I B (SG), H A R D E R I A N G L A N D (HG) , A U D I T O R Y S E B G L (AS), S K I N (SK) , U R I N A R Y B L A D D E R ( U B ) , P R O S T A T E (PR), S E M I N A L V E S I C L E S (SV), T E S T I S ( T E ) , E P I D I D Y M I D E S (EP)
382
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
U
00
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO M I D Z O N A L ,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 (J E ) , 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)
(T>
G^viv
384
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
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0519 2.0730 3.9593 26.0579
.6285 3.4019
.2799 .0246
.0110 % .4381 % .8367 % 5.5067 %
.1328 % .7189 % .0592 % .0052 %
.0250 1.0000 1.9099 12.5701
.3032 1.6411
.1350 .0119
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LIVER (LI) : -LARGE; ALL LOBES THICKENED, MARGINS ROUNDED -DIFFUSELY DARK; ALL LOBES: DARK BROWN
STOMACH, GL (ST) : -DARK FOCUS(I)/AREA(S); MUCOSA: SINGLE DARK BROWN FOCUS, MM IN DIAMETER
1
h*
oc e
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
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY),BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN) , SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
(PR),
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) ,BRAIN (BR) , SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
'H i
oe
p
386
APPENDIX 6 Individual Anatomic Pathology Data
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 WEE K OF DEATH: 14
TERMINAL BODY WEIGHT:
462.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:07
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0554 2.2840 4.5315 30.5553
.7488 3.8137
.2714 .0220
.0120 % .4934 % .9789 % 6.6008 % .1618 % .8239 % .0586 % .0048 %
.0243 1.0000 1.9840 13.3780
.3278 1.6697
.1188 .0096
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -INFILTRATE, MACROPHAGE, A L V E O L A R ,-MINIMAL
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -NECROSI S , COAGULATIVE,-MINIMAL -NECROSIS, INDIVIDUAL HEPATO C Y T E ,-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
C01132
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 (J E ) , 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)
Q
388
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
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
ABSOLUTE ORGAN WEIGHT (GRAMS)
.0569 2.1026 4.2312 24.8958
.5544 3.5478
.2759 .0214
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
.0135 % .4984 % 1.0029 % 5.9009 % .1314 % .8409 % .0654 % .0051 %
ORGAN TO BRAIN WEIGHT RATIO
.0271 1.0000 2.0124 11.8405
.2637 1.6873
.1312 .0102
ORGAN STATUS
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LIVER (LI) : -LARGE; ALL LOBES: THICKENED -DIFFUSELY DARK; ALL LOBES: DARK BROWN
|rJh
J
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO M I D Z O N A L ,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 TIME OF NECROPSY: 12/02/98 11:04
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL(SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), MUSCLE,SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
390
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: 103
ANIMAL NUMBER: C95966
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
444.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:53
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
O R GA N STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) T H Y R O I D /PA R A T H Y R
(TT)
.0524 2.0426 4.8321 20.9821
.7381 3.0674
.3532 .0227
.0118 % .4597 % 1.0876 % 4.7225 % .1661 % .6904 % .0795 % .0051 %
.0257 1.0000 2.3657 10.2723
.3614 1.5017
.1729 .0111
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
O B S E R V A T I (I N S
HISTOPATHOLOGY
1 r-*
f *Jk cs m
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
LN, MESENTERIC (MS) : -HEMORRHAGE, -MINIMAL
THYROID (TY) : -C Y S T , ULTIMOBRANCHIAL,-PRESENT
URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
391
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 104
ANIMAL NUMBER: C95966
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS:
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:I: 93
STUDY WEEK OF DEATH: 14
DATE AND TIME OF NECROPSY: 12/02/98 7:53
PROSECTOR: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 444.3 GRAMS
RECORDER: WENDY CHERRY 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 (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR),
SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) ,BRAIN (BR) ,
SPINAL CORD (SC), TRACHEA
(TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE,
SPLEEN (SP), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI),
STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE),
COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS),
SKIN (SK), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
SCIATIC(SN),
392
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: 105
ANIMAL NUMBER: C95967
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
447.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 9:54
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME-
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0473 2.1398 4.1495 25.0600
.4205 3.2710
.1537 .0278
.0106 % .4778 % .9266 % 5.5962 % .0939 % .7305 % .0343 % .0062 %
.0221 1.0000 1.9392 11.7114
.1965 1.5286
.0718 .0130
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
KIDNEY (KD) : -LARGE PELVIS (ES) ; LEFT
THYMUS (TH) : -DIFFUSELY RED; RIGHT LOBE
r* fJk
GD
LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL -VACUOLATION, HEPATOCELLULAR, DIFFUSE,-SLIGHT >NOTE:>PIGMENT IS CONCENTRATED IN THE CYTOPLASM OF CENTRILOBULAR HEPATOCYTES NEAR BILE CANALICULI.
KIDNEY (KD) : -DILATATION, PELVIC,-SLIGHT
THYMUS (TH) : -HEMORRHAGE, -MINIMAL -INVOLUTION, -MINIMAL
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
PITUITARY (PI) : -CYST,-PRESENT
393
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 106
ANIMAL NUMBER: C95967
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
447.8 GRAMS
DATE AND POST-FIX
TWIEMIGE
HOEFR
:
NEWCORTOPASVYA:I
12/02/ LABLE
98
9:54
PROSECTOR: MICHELE ZIMA PATHOLOGIST: JOHN EIGHMY
RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT
AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT
PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDER IAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
(SV) ,
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES),HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) ,HARDERIAN GLAND (HG) , SKIN (SK) , URINARY BLADDER (UB) , SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
CO 394
APPENDIX 6 Individual Anatomic Pathology Data
Covanee 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 107
ANIMAL NUMBER: C95968
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
459.5 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 9:58
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0730 2.1136 4.2887 24.0192
.9478 2.8087
.2901 .0236
.0159 % .4600 % .9333 % 5.2272 % .2063 % .6113 % .0631 % .0051 %
.0345 1.0000 2.0291 11.3641
.4484 1.3289
.1373 .0112
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS
-)
LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL
ADRENAL, CORTEX (AC) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
CD
C
395
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 108
ANIMAL NUMBER: C95968
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:I: 93
STUDY WEE K OF DEATH: 14
TERMINAL BODY WEIGHT: 459.5 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 9:58
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD) , HEART (HT) ,MUSCLE, SKELETAL (SM) NERVE, SCIATIC (SN) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEE GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
,
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) ,
SPINAL CORD (SC), TRACHEA
(TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM),
NERVE, SCIATIC(SN),
SPLEEN (SP), THYMUS (TH) , LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO),
PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
396
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 109
ANIMAL NUMBER: C95969
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
465,8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:41
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
OR G A N STATUS
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 % .0054 %
.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
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
KIDNEY (KD) : -LARGE PELVIS(ES); RIGHT
-*-1 STOMACH, GL (ST) : U k -DARK FOCUS(I)/AREA(S); MUCOSA: MULTIPLE DARK BROWN AREAS,
UP TO 2 X 1 MM
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL
KIDNEY (KD) : -DILATATION, P E LVIC,-MODERATE
HEART (HT) : - D E G E N E R A T I O N / N E C R O S I S ,- M I N I M A L
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
STOMACH, GL (ST) : -EROSION, -MINIMAL
PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
397
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 110
ANIMAL NUMBER: C95969
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
465.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:41
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
PROSTATE (PR) : -INFLAMMATION, CHRONIC-ACTIVE, -MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
(PR),
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), A O R T A (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
U
398
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: 111
ANIMAL NUMBER: C95970
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
439.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:47
PROSECTOR: GREGORY CODDINGTON
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
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)
.0560 2.2490 3.7296 23.2250
.6436 3.5189
.2718 .0230
.0127 % .5115 % .8482 % 5.2820 % .1464 % .8003 % .0618 % .0052 %
.0249 1.0000 1.6583 10.3268
.2862 1.5647
.1209 .0102
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LN, MANDIBULAR (MN) : -MOTTLED; BILATERAL: DARK RED AND TAN
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL UPPER INCISORS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, COAGULATIVE,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
PANCREAS (PA) : -INFLAMMATION, CHRONIC-ACTIVE, -MINIMAL -PIGMENT, BROWN,-MINIMAL
LN, MANDIBULAR (MN) : -HEMORRHAGE, -MINIMAL
399
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: 112
ANIMAL NUMBER: C95970
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
439.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:47
PROSECTOR: GREGORY CODDINGTON
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, N O N G L (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), S A L I V G L , MANDIB (SG) , HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), S A L I V G L , MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
coll'
Qin
400
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 113
ANIMAL NUMBER: C95971
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 309.1 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:57
PROSECTOR: MATTHEW AXTMAN
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
14.5443 -----------------------------
----------------------
4.7054 -----------------------------
%
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, N O N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
o
r*
&
401
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: 114
ANIMAL NUMBER: C95972
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS:
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
DATE AND TIME OF NECROPSY: 10/01/98 12:06
PROSECTOR: MATTHEW AXTMAN
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 333.3 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
14.9723 -----------------------------
----------------------
4.4921 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
**>Tfy J
Vi
402
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 115
ANIMAL NUMBER: C95973
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 276.7 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:48
PROSECTOR: WENDY CHERRY
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
13.1995 -----------------------------
----------------------
4.7703 -----------------------------
%
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID <PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
h*
00
403
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 116
ANIMAL NUMBER: C95974
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS:
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
DATE AND TIME OF NECROPSY: 10/01/98 11:22
PROSECTOR: TONY HANFELD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 311.4 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) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
14.4142 -----------------------------
----------------------
4.6288 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, N O N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , 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)
f.5 C3
404
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 117
ANIMAL NUMBER: C95975
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT:
327.4 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:53
PROSECTOR: MATTHEW AXTMAN
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
16.4042 -----------------------------
----------------------
5.0104 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, N O N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , 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)
<*>
9 * ,
' f T
U
O
405
APPENDIX 6 individual Anatomie Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 118
ANIMAL NUMBER: C95976
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 382.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:23
PROSECTOR: JILL PAUS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STA TUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI)
SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0447 2.1994 3.5516 21.3634
.4872 3.4775
.2380 .0300
.0117 % .5746 % .9278 % 5.5808 % .1273 % .9084 % .0622 % .0078 %
.0203 1.0000 1.6148 9.7133
.2215 1.5811
.1082 .0136
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OB SERVAT I0N S
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL
THYMUS (TH) : -HEMORRHAGE, -MINIMAL
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
LN, MANDIBULAR (MN) : -HEMORRHAGE,-SLIGHT
o
406
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 119
ANIMAL NUMBER: C95976
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:I: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 382.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:23
PROSECTOR: JILL PAUS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN) , SPLEEN (SP) , LN, MESENTERIC (MS), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), J E J UNUM (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)
'S tA
w
o
N
407
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: 120
ANIMAL NUMBER: C95977
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
454.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:58
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
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)
.0587 2.0929 4.2673 25.0541
.7871 3.4440
.2202 .0339
.0129 % .4604 % .9387 % 5.5112 % .1731 % .7576 % .0484 % .0075 %
.0280 1.0000 2.0389 11.9710
.3761 1.6456
.1052 .0162
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 PINPOINT FOCI
LN, MANDIBULAR <MN) : -DIFFUSELY RED; BILATERAL
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
~ - -- -- -- --
LOBES: --
MULTIPLE DARK RED, -- -- --
LUNG (LU) : -INFILTRATE, MACROPHAGE, A L V E O L A R ,-MINIMAL
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -VACUOLATION, HEPATOCELLULAR, DIFFUSE,-SLIGHT
HEART (HT) : - D E G E N E R A T I O N / N E C R O S I S ,- M I N I M A L
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL
C'O O CO
408
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 121
ANIMAL NUMBER: C95977
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
454.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:58
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD),HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), 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), J E JUNUM (JE), ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
* I.v
409
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: 122
ANIMAL NUMBER: C95978
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
454.2 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:40
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0568 2.1377 3.6874 28.4115
.6243 3.8868
.1836 .0245
.0125 % .4707 % .8118 % 6.2553 % .1375 % .8557 % .0404 % .0054 %
.0266 1.0000 1.7249 13.2907
.2920 1.8182
.0859 .0115
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LIVER (LI) :
-LIGHT FOCUS(I)/AREA(S); DIAPHRAGMATIC SURFACE OF LEFT LATERAL LOBE: MULTIPLE TAN AREAS, PINPOINT AND UP TO 1 MM IN DIAMETER; COLLECTED ON ROUTINE SECTION
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, COAGULATIVE,-SLIGHT -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL, SLIGHT
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
<r>
tv
o
C/I
410
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.X
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 123
ANIMAL NUMBER: C95978
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
454.2 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:40
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP>, THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR),
SPINAL CORD (SC), TRACHEA
(TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM),
NERVE,SCIATIC
SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO),
PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) ,
CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG),
AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP)
(SN),
W
o
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: 124
ANIMAL NUMBER: C95979
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
435.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:16
PROSECTOR: LAURIE J. SCHULLER
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0499 2.2608 3.8911 23.2324
.6649 3.4924
.2278
.0253
.0115 % .5197 % .8945 % 5.3408 % .1529 % .8029 % .0524 % .0058 %
.0221 1.0000 1.7211 10.2762
.2941 1.5448
.1008 .0112
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
W -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-SLIGHT
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT
H ------------------------------------------
j
412
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 125
ANIMAL NUMBER: C95979
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEE K OF DEATH: 14
TERMINAL BODY WEIGHT:
435.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:16
PROSECTOR: LAURIE J. SCHULLER
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE>, BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA> , AORTA (AO), PITUITARY (PI), STOMACH. GL (ST), STOMACH, N O N G L (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE). LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , SKIN (SK) , URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES TESTIS (TE) ,' EPIDIDYMIDES (EP)
(SV) ,
-) o
GO
*
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: 126
ANIMAL NUMBER: C95980
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 434.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:24
PROSECTOR: KEVIN BILLINGS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR
(TT)
.0539 2.2717 4.2176 24.1794
.6736 3.5469
.2741 .0237
.0124 % .5234 % .9718 % 5.5713 % .1552 % .8173 % .0632 % .0055 %
.0237 1.0000 1.8566 10.6437
.2965 1.5613
.1207 .0104
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL
AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT
<*>
O
(3
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:I: 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 (J E ) , 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 (J E ) , 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)
O
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 1.0000 1.3023 5.7134
.0488 .4837 .1466 .0124
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
SPLEEN (SP) : -ADHESION (S) ; ENTIRE SPLEEN ADHERED TO PANCREAS AND SURROUNDING ADIPOSE TISSUE: MULTIPLE GRAY AND TAN FIBROUS ADHESIONS; COLLECTED INTACT
PITUITARY (PI) : -LARGE; 6 X 5 X 3 MM; APPEARS SWOLLEN
r>
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
SPLEEN (SP) : -INFLAMMATION, CHRONIC, CAPSULAR,-MODERATE > N O T E :>THERE ARE NUMEROUS PIGMENT-CONTAINING 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
MACROPHAGES
IN
i>5 V* V*
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)
'" N
to to
417
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: 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
OB SERVA T ION S
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
;1T^
b I*
u
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 (J E ) , 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)
C'v P
419
APPENDIX 6 Individual Anatomic Pathology Data
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 2.1211 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 1.0000 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
'* 9 0
pk
4*3
**
cn
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 (J E ) , 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
APPENDIX 6 individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 134
ANIMAL NUMBER: C95984
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 266.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:26
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
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
O B S E R V A T I ONS
HISTOPATHOLOGY
UTERUS (UT) : -LUMEN FILLED WITH FLUID;
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
BILATERAL: CLEAR FLUID
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
UTERUS (UT) : >U N R E M A R K A B L E
0
P
J
422
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 135
ANIMAL NUMBER: C 9 5 9 8 4
SEX: FEMALE
DATE O F DEATH: 1 2 / 0 2 / 9 8
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 12:26
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 1
SACRIFICE STATUS:
D E A T H :[: 93
S T U D Y W E E K O F DEATH: 14
PROSECTOR: J E R A L D W. J O H N S O N
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE
TERMINAL BODY WEIGHT:
266.8
RECORDER: WENDY CHERRY
WEIGHER: LYNN HORNER
GRAMS
THE
FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, F E M U R (FE) ,M A R R O W , F E M U R (FM) ,M A R R O W , S T E R N U M (SE), BONE, S T E R N U M (SB), E Y E (EY) , B R A I N (BR) , S P I N A L C O R D (SC), L U N G ( L U ) , T R A C H E A ( T R ) , E S O P H A G U S ( E S ) , L I V E R (LI), K I D N E Y ( K D ) , H E A R T (HT ) , MUSCLE, S K E L E T A L ( SM), NERVE, S C I A T I C ( S N ) , S P L E E N ( S P ) , T H Y M U S ( T H ) , LN, M E S E N T E R I C (MS), T H Y R O I D ( T Y ) , P A R A T H Y R O I D (PT), ADRENAL, C O R T E X (AC), A D RENAL, M E D U L L A ( M A ) , A O R T A (AO), P I T U I T A R Y (PI), STOMACH, GL (ST), STOMACH, N O N G L ( S U ) , P A N C R E A S (PA), D U O D E N U M (DU), J E J U N U M (J E) , I L E U M (IL) , C E C U M (CE) , C O L O N (CO), R E C T U M (RE), LN, M A N D I B U L A R (MN) , S A L I V GL, M A N D I B (SG) , H A R D E R I A N G L A N D (HG) , A U D I T O R Y S E B G L (AS), S K I N (SK) , M A M M A R Y , F E M A L E (MF) , U R I N A R Y B L A D D E R ( U B ) , C E R V I X ( C V ) , O V A R Y ( O V ) , V A G I N A ( V A ) , T A I L (TI)
THE
FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: B O NE, F E M U R ( F E ) ,M A R R O W , F E M U R (FM) ,M A R R O W , S T E R N U M ( S E ) , BONE, S T E R N U M (SB), E Y E ( E Y ) , B R A I N ( B R ) , S P I N A L C O R D (SC), L U N G ( L U ) , T R A C H E A ( T R ) , E S O P H A G U S ( E S ) , L I V E R (LI), K I D N E Y ( K D ) , H E A R T ( HT), M USCLE, S K E L E T A L ( S M ) , NERVE, S C I A T I C ( S N ) , S P L E E N ( S P ) , T H Y M U S ( T H ) , LN, M E S E N T E R I C (MS), P A R A T H Y R O I D ( P T ) , ADREN A L , C O R T E X (AC), ADRENAL, M E D U L L A ( M A ) , A O R T A (AO), P I T U I T A R Y (PI), STOMACH, G L (ST), STOMACH, N O N G L ( S U ) , P A N C R E A S (PA), D U O D E N U M (DU), J E J U N U M (JE) , I L E U M (IL) , C E C U M (CE) , C O L O N (CO), R E C T U M (RE), LN, M A N D I B U L A R (MN) , S A L I V GL, M A N D I B ( SG), H A R D E R I A N G L A N D ( H G ) , A U D I T O R Y S E B G L (AS), S K I N ( S K ) , M A MMARY, F E M A L E (MF ) , U R I N A R Y B L A D D E R (UB) , C E R V I X (CV) , O V A R Y (OV) , V A G I N A (VA)
423
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: 136
ANIMAL NUMBER: C95985
SEX: FEMALE
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 11:20
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 1
SACRIFICE STATUS:
D E A T H : 93
STUDY WEEK OF DEATH: 14
PROSECTOR : JILL PAUS
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE T E R M I N A L B O D Y W E I G H T : 283.,0 G R A M S
RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE T O B O D Y W E I G H T (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
A D R E N A L (AD) B R A I N (BR) K I D N E Y (KD) L I V E R (LI) O V A R Y (OV) S P L E E N (SP) T H Y M U S (TH) THYROID/PARATHYR
(TT)
.0785 2.0288 2.1159 8.9903
.1524 .5420 .2466 .0227
.0277 .7169 .7477 3.1768 .0539 .1915 .0871 .0080
% % % % % % % %
.0387 1.0000 1.0429 4.4313
.0751 .2672 .1215 .0112
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
TAKEN TAKEN TAKEN TAKEN TAKEN TAKEN TAKEN TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
G E N E R A L C O M M E N T (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
L I V E R (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
LN, M A N D I B U L A R (MN) -HEMORRHAGE,-MINIMAL
A U D I T O R Y S E B G L (AS) -ONE E X A M I N E D ,-PRESENT
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3 M T - 6 3 1 4 .1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE; 137
ANIMAL NUMBER: C95985
SEX: FEMALE
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 11:20
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 1
SACRIFICE STATUS:
D E A T H :1: 93
S T U D Y W E E K O F DEATH: 14
PROSECTOR: JILL PAUS
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE
TERMINAL BODY WEIGHT:
283.0
RECORDER: WENDY CHERRY
WEIGHER: LYNN HORNER
GRAMS
THE
FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: B O N E , F E M U R (FE) ,M A R R O W , F E M U R (FM) ,M A R R O W , S T E R N U M (SE) , B O N E , S T E R N U M (SB), E Y E (EY) , B R A I N (BR) , S P I N A L C O R D (SC), L U N G ( L U ) , T R A C H E A ( T R ) , E S O P H A G U S ( E S ) , L I V E R (LI), 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 E R V E , S C I A T I C ( S N ) , S P L E E N ( S P ) , T H Y M U S ( T H ) , LN, M E S E N T E R I C (MS), T H Y R O I D ( T Y ) , P A R A T H Y R O I D (PT) , A D RENAL, C O R T E X (AC), A D RENAL, M E D U L L A ( M A ) , A O R T A (AO), P I T U I T A R Y (PI), STOMACH, G L (ST), STOMACH, N O N G L ( SU), P A N C R E A S (PA), D U O D E N U M (DU), J E J U N U M (JE) , I L E U M (IL) , C E C U M (CE) , C O L O N (CO), R E C T U M (RE), LN, M A N D I B U L A R (MN) , S A L I V GL, M A N D I B (SG) , H A R D E R I A N G L A N D (HG) , A U D I T O R Y S E B G L (AS), S K I N (SK) , M A M M A R Y , F E M A L E (MF) , U R I N A R Y B L A D D E R ( U B ) , U T E R U S ( U T ) , C E R V I X ( C V ) , O V A R Y ( O V ) , V A G I N A ( V A ) , T A I L (TI)
THE
FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: B O NE, F E M U R (FE) ,M A R R O W , F E M U R (FM) ,M A R R O W , S T E R N U M (SE), B O NE, S T E R N U M (SB), E Y E (EY) , B R A I N (BR) , S P I N A L C O R D (SC), L U N G ( L U ), T R A C H E A ( T R ) , E S O P H A G U S ( E S ) , K I D N E Y ( K D ) , H E A R T ( H T),MUSCLE, S K E L E T A L (SM ) , NERVE, S C I A T I C ( SN), S P L E E N ( S P ) , T H Y M U S ( T H ) , LN, M E S E N T E R I C (MS), T H Y R O I D (TY), P A R A T H Y R O I D ( P T ) , ADRENAL, C O R T E X (AC), A D RENAL, M E D U L L A ( M A ) , A O R T A (AO), P I T U I T A R Y (PI), STOMACH, G L (ST), STOMACH, N O N G L ( SU), P A N C R E A S (PA), D U O D E N U M (DU), J E J U N U M (J E) , I L E U M (IL) , C E C U M (CE) , C O L O N (CO), R E C T U M (RE), S A L I V GL, M A N D I B (SG) , H A R D E R I A N G L A N D (HG) , S K I N (SK) , M A M M A R Y , F E M A L E (MF) , U R I N A R Y B L A D D E R (UB) , U T E R U S (UT) , C E R V I X (CV) , O V A R Y (OV) , V A G I N A (VA)
425
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
H
C2
S'?
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 138
ANIMAL NUMBER: C95986
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
264.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:34
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0824 1.9890 2.1350 7.8859
.1421 .5597 .3403 .0156
.0312 % .7526 % .8078 % 2.9837 %
.0538 % .2118 % .1288 % .0059 %
.0414 1.0000 1.0734 3.9648
.0714 .2814 .1711
.0078
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
426
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 139
ANIMAL NUMBER: C95986
SEX: FEMALE
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 12:34
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 1
SACRIFICE STATUS:
D E A T H ::: 93
S T U D Y W E E K O F DEATH: 14
PROSECTOR: GREGORY CODDINGTON
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE
TERMINAL BODY WEIGHT:
264.3 GRAMS
R E C O R D E R : T E R R I L. W I L L I A M S
WEIGHER: TONY HANFELD
THE
FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
B O N E , F E M U R (FE) ,M A R R O W , F E M U R (FM) ,M A R R O W , S T E R N U M (SE), B O N E , S T E R N U M (SB), E Y E (EY) , B R A I N (BR) ,
SPINAL CORD
(SC), L U N G ( L U ) , T R A C H E A ( T R ) , E S O P H A G U S ( E S ) , L I V E R (LI), K I D N E Y ( K D ) , H E A R T ( H T ) ,MUSCLE, S K E L E T A L ( S M ) ,
NERVE, S C I A T I C ( S N ) , S P L E E N (SP) , T H Y M U S ( T H ) , LN, M E S E N T E R I C (MS), T H Y R O I D ( T Y ) , P A R A T H Y R O I D ( P T ) ,
ADRENAL, C O R T E X (AC), AD R E N A L , M E D U L L A ( M A ) , A O R T A (AO), P I T U I T A R Y (PI), STOMACH, G L (ST), STOMACH, N O N G L ( S U ) ,
P A N C R E A S (PA), D U O D E N U M (DU), J E J U N U M (JE) , I L E U M (IL) , C E C U M (CE) , C O L O N (CO), R E C T U M (RE), LN, M A N D I B U L A R (MN) ,
S A L I V GL, M A N D I B (SG) , H A R D E R I A N G L A N D ( H G ) , A U D I T O R Y S E B G L (AS), S K I N ( S K ) , M A M M A R Y , F E M A L E (MF) ,
U R I N A R Y B L A D D E R ( U B ) , U T E R U S ( U T ) , C E R V I X ( C V ) , O V A R Y ( O V ) , V A G I N A ( V A ) , T A I L (TI)
THE
FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: B O N E , F E M U R ( F E ) ,M A R R O W , F E M U R ( F M ) ,M A R R O W , S T E R N U M ( S E ) , B O N E , S T E R N U M (SB), E Y E ( E Y ) , B R A I N ( B R ) , S P I N A L C O R D (SC), L U N G ( L U ) , T R A C H E A ( T R ) , E S O P H A G U S ( E S ) , L I V E R (LI), 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 ) , NERVE, S C I A T I C ( S N ) , S P L E E N ( S P ) , T H Y M U S ( T H ) , LN, M E S E N T E R I C (MS), T H Y R O I D ( T Y ) , P A R A T H Y R O I D ( P T ) , ADRENAL, C O R T E X (AC), AD R E N A L , M E D U L L A ( M A ) , A O R T A (AO), P I T U I T A R Y (PI), STOMACH, G L (ST), STOMACH, N O N G L ( S U ) , P A N C R E A S (PA), D U O D E N U M (DU), J E J U N U M (J E ) , I L E U M ( I L ) , C E C U M ( C E ) , C O L O N (CO), R E C T U M (RE), LN, M A N D I B U L A R ( M N ) , S A L I V GL, M A N D I B ( S G ) , H A R D E R I A N G L A N D ( H G ) , A U D I T O R Y S E B G L (AS), S K I N ( S K ) , M A MMARY, F E M A L E ( M F ) , U R I N A R Y B L A D D E R (UB) , U T E R U S (UT) , C E R V I X ( C V ) , O V A R Y ( O V ) , V A G I N A (VA)
427
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: 140
ANIMAL NUMBER: C95987
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
244.1 GRAMS
DATE AND TIME OF NECROPSY; 12/02/98 10:51
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD)
BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0980 1.8897 1.9180 7.2576
.1316 .4780 .3293 .0233
.0401 % .7741 % .7857 % 2.9732 % .0539 % .1958 % .1349 % .0095 %
.0519 1.0000 1.0150 3.8406
.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
t., O
I-*) '
CO 428
APPENDIX 6 Individual Anatomic Pathology Data
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)
V
429
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: 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
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)
.0716 1.8513 1.8853 7.0591
.1193 .4753 .3660 .0136
.0283 % .7329 % .7464 % 2.7946 % .0472 % .1882 % .1449 % .0054 t
.0387
1.0000 1.0184 3.8131
.0644 .2567 .1977 .0073
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC. -MINIMAL
KIDNEY (KD) : -MINERALIZATION, TUBULAR,-MINIMAL
THYMUS (TH) :
-HEMORRHAGE,-MINIMAL THYROID (TY) :
-CYST, ULTIMOBRANCHIAL,-PRESENT
tv
C/l
430
APPENDIX 6 Individual Anatomic Pathology Data
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 (J E ) , 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)
<*>
cO tv
m
431
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 144
ANIMAL NUMBER: C95989
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 277.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:40
PROSECTOR: LAURIE J. SCHULLER
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
ABSOLUTE ORGAN WEIGHT (GRAMS)
.0673 1.9052 1.9871 7.3952
.1033 .5285 .2674 .0121
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
.0243 % .6878 % .7174 % 2.6697 % .0373 % .1908 % .0965 % .0044 %
ORGAN TO BRAIN WEIGHT RATIO
.0353 1.0000 1.0430 3.8816
.0542 .2774 .1404 .0064
ORGAN STATUS
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LUNG (LU) : -MINERALIZATION, VASCULAR, -MINIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
-NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYROID (TY) :
-CYST, ULTIMOBRANCHIAL,-PRESENT AUDITORY SEB GL (AS) :
-ONE EXAMINED,-PRESENT
's (v
432
APPENDIX 6 Individual Anatomic Pathology Data
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:I: 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
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 146
ANIMAL NUMBER: C95990
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 313.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:30
PROSECTOR: KIMBERLY DURLAND
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
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
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HE P A T O C Y T E ,-MINIMAL
r>
434
APPENDIX 6 individual Anatomic Pathology Data
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:I: 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 (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR),
SPINAL CORD (SC), TRACHEA
(TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM),
SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC),
ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA),
DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) ,
SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) ,
URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA)
NERVE, SCIATIC(SN),
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 % -----------------------------
---------------------------------------------------------
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, N O N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), 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)
f")
10 tt . 'V\ p
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, N O N G L (SU), PANCREAS (PA) , DUODENUM (DU) , JEJUNUM (JE) , 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)
ns
-S
-4P^
u
fs5
437
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: 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)
`-W*
iO CO
CO
438
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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: 10/01/9B 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)
:.-x {tWv'
439
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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)
M
cn
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
0B SERVATIONS
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) : - H E M O R R H A G E , --MINIMAL
rs
i-J u m
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
ANIMAL NUMBER: C95996
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
268.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:35
PROSECTOR: JILL PAUS
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE,SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA) , DUODENUM (DU) , JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO) , RECTUM (RE) , LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA)
*y
U
442
APPENDIX 6 Individual Anatomic Pathology Data
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 WEE K 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
J' Lj
00
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 (J E ) , 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)
r>
444
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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 WEE K OF DEATH: 14
TERMINAL BODY WEIGHT:
240.2 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:40
PROSECTOR: KIMBERLY DURLAND
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0641 2.0289 1.8478 6.0936
.1647 .4325 .3476 .0341
.0267 % .8447 % .7693 % 2.5369 % .0686 % .1801 % .1447 % .0142 %
.0316 1.0000
.9107 3.0034
.0812 .2132 .1713 .0168
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT
s t'O
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:
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:i: 93
STUDY WEEK OF DEATH: 14
DATE AND TIME OF NECROPSY: 12/02/98 8:40
PROSECTOR: KIMBERLY DURLAND
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 240.2 GRAMS
RECORDER: STEVE VAN ADESTINE 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)
ir 446
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 159
ANIMAL NUMBER: C95999
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
358.4 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:25
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0752 2.0931 2.4475 9.9107
.1232 .5403 .3750 .0228
.0210 % .5840 % .6829 % 2.7653 % .0344 % .1508 % .1046 % .0064 %
.0359 1.0000 1.1693 4.7349
.0589 .2581 .1792 .0109
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
**
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
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 8:25
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 1
SACRIFICE STATUS:
DEATH:1: 93
STUDY WEEK OF DEATH: 14
PROSECTOR: JERALD W. JOHNSON
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 358.4 GRAMS
RECORDER: WENDY CHERRY 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 (J E ) , 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)
Tij 3
448
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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
i"S p,
1*
449
APPENDIX 6 Individual Anatomic Pathology Data
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
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 10:11
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 1
SACRIFICE STATUS:
DEATH:\ i 93
aSxT:U\ jDuYi Ww CEiCEiAK. uOFr jDEATH: 14
PROSECTOR: TODD ACKER
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 269.7
RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER
GRAMS
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)
1
450
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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
FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST : JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0574 1.8284 2.1472 7.2356
.1433 .5303 .3077 .0305
.0246 % .7834 % .9200 % 3.1001 % .0614 % .2272 % .1318 % .0131 %
.0314 1.0000 1.1744 3.9573
.0784 .2900 .1683 .0167
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), 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, N O N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD)
LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH)
THYROID/PARATHYR
(TT)
.0630 2.0244 1.9083 7.1598
.1099 .4890 .2793 .0179
.0276 % .8863 % .8355 % 3.1348 % .0481 % .2141 % .1223 % .0078 %
.0311 1.0000
.9426 3.5368
.0543 .2416 .1380 .0088
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
UTERUS (UT) : -LUMEN FILLED WITH FLUID;
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
BILATERAL; CLEAR FLUID
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
UTERUS (UT) : -DILATATION,-SLIGHT
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC) , LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI) , KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
';*"T'*<
tO
t r-'J
Si
452
APPENDIX 6 Individual Anatomic Pathology Data
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 1.0000
.8721 3.2920
.0575 .2774 .1390 .0098
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
UTERUS (UT) : -LUMEN FILLED WITH FLUID;
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
BILATERAL: CLEAR FLUID
UTERUS (UT) : -DILATATION,-MODERATE
s Uk
10
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 W EEK 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 (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (5K) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI)
*S
CD
454
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 167
ANIMAL NUMBER: C96004
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 263.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:34
PROSECTOR: TODD ACKER
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0516 1.9505 2.2579 8.3001
.1230 .5005 .2900 .0143
.0196 % .7399 % .8566 % 3.1487 % .0467 % .1899 % .1100 % .0054 %
.0265 1.0000 1.1576 4.2554
.0631 .2566 .1487 .0073
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
i**V
0
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 168
ANIMAL NUMBER: C96004
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
263.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:34
PROSECTOR: TODD ACKER
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR <FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, N O N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
id
Cl
|u^
456
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 169
ANIMAL NUMBER: C96005
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
243.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:05
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0702 1.8993 2.2248 8.2448
.1103 .4497 .3365 .0162
.0288 % .7794 % .9129 % 3.3832 % .0453 % .1845 % .1381 % .0066 %
.0370 1.0000 1.1714 4.3410
.0581 .2368 .1772 .0085
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA) , TAIL (TI)
fW \
457
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL {N-MEFOSE, T-6314) IN RATS
PAGE: 170
'T*'
0
(/ 0
ANIMAL NUMBER: C96006
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
249.2 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:36
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0512 1.9754 1.8567 7.3435
.1079 .4943 .2233 .0032
.0205 % .7927 % .7451 % 2.9468 % .0433 % .1984 % .0896 % .0013 %
.0259 1.0000
.9399 3.7175
.0546 .2502 .1130 .0016
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV) , OVARY (OV) , VAGINA (VA), TAIL (TI)
458
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 171
ANIMAL NUMBER: C96007
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 252.5 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:06
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0765 2.0179 2.2417 8.5804
.1210 .6280 .3639 .0251
.0303 % .7992 % .8878 % 3.3982 % .0479 % .2487 % .1441 % .0099 %
.0379 1.0000 1.1109 4.2521
.0600 .3112 .1803 .0124
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) ,
PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), -v 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)
4,5
459
APPENDIX 6 individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
O *V T*
r*
cn c/i
13-WEEK DIETARY TOXICITY STUDY WITH N- METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 172
ANIMAL NUMBER: C96008
SEX: FEMALE
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 10:19
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 2
SACRIFICE STATUS:
DEATH: 93
STUDY WEEK OF DEATH: 14
PROSECTOR: MICHELE ZIMA
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT': 277..6 GRAMS
RECORDER: WENDY CHERRY 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) 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)
---------------- _--------- ----------- ------ -----------------____________________ ______ _______________ __________________ ____________
460
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-63X4.1
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
p,
w
cn 5
461
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 174
ANIMAL NUMBER: C96009
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS:
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:i; 9; 3j
oSTi uUuDiY WyvEilEcjIKS. \OjFr jDEATH: 14
DATE AND TIME OF NECROPSY: 12/02/98 8:20
PROSECTOR: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 208.7 GRAMS
RECORDER: WENDY CHERRY 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)
co i
<5
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 STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0658 2.0743 2.0370 8.2431
.0965 .5876 .3850 .0181
.0250 % .7887 % .7745 % 3.1343 % .0367 % .2234 % .1464 % .0069 %
.0317 1.0000
.9820 3.9739
.0465 .2833 .1856 .0087
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NO N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
ro
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 (J E ) , 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)
r*
3
C/l
464
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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)
P U
oo
465
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 178
ANIMAL NUMBER: C96013
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 223.1 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:31
PROSECTOR: WENDY CHERRY
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
7.7373 -----------------------------
----------------------
3.4681 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEE GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA) , TAIL (TI) , GENERAL COMMENT (GC)
r>
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)
iO
467
APPENDIX 6 individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 180
ANIMAL NUMBER: C96015
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK 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)
r*
e.
CO
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 DATE OF DEATH: 10/29/98
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: UNSCHEDULED (M)
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
r*
i0
Ci
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
DATE OF DEATH: 10/29/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 10/29/98 15:09
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 2
SACRIFICE STATUS:
DEATH:!: 59
STUDY WEEK OF DEATH: 9
PROSECTOR: JAMES T. CALLEN
PATHOLOGIST: JOHN EIGHMY
UNSCHEDULED (M) TERMINAL BODY WEIGHT: 272.9
RECORDER: JAMES T. CALLEN WEIGHER: JAMES T. CALLEN
GRAMS
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 (J E ) , 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)
r>
470
APPENDIX 6 Individual Anatomic Pathology Data
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)
C'U 2 G 6
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
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0805 1.9028 2.0616 8.0095
.1174 .5094 .2793 .0175
.0288 % .6803 % .7371 % 2.8636 % .0420 % .1821 % .0999 % .0063 %
.0423 1.0000 1.0835 4.2093
.0617 .2677 .1468 .0092
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
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)
i3
a
472
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.I
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 185
ANIMAL NUMBER: C96019
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 283.2 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:12
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0860 2.0462 2.6887 8.9464
.1290 .5329 .3098 .0209
.0304 % .7225 % .9494 % 3.1590 % .0456 fc .1882 % .1094 % .0074 %
.0420 1.0000 1.3140 4.3722
.0630 .2604 .1514 .0102
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
UTERUS (UT) : -LUMEN FILLED WITH FLUID;
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
BILATERAL: CLEAR FLUID
UTERUS (UT) : -DILATATION,-SLIGHT
a oo
473
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: 186
ANIMAL NUMBER: C96019
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 283.2 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:12
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
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)
V
i0
a
474
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 187
ANIMAL NUMBER: C96020
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 239.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:06
PROSECTOR: JOHN S. HALFORD
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
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 <%)
.0311 % .7927 % .8709 % 3.4685 .0550 % .1879 % .1140 % .0072 %
ORGAN TO BRAIN WEIGHT RATIO
.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
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 ISM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN),
? ^ SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), *' URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
o-i ---------------------------------------- ---------------- -------------------------------------- -- .................... .............. -......
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
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
ABSOLUTE ORGAN WEIGHT (GRAMS)
.0599 1.9833 2.1418 7.9743
.1125 .5182 .2110 .0159
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
.0250 % .8274 % .8935 % 3.3268 % .0469 % .2162 % .0880 % .0066 %
ORGAN TO BRAIN WEIGHT RATIO
.0302 1.0000 1.0799 4.0207
.0567 .2613 .1064 .0080
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
k h <^
:.>
476
APPENDIX 6 Individual Anatomic Pathology Data
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
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEE K OF DEATH: 14
TERMINAL BODY WEIGHT: 239.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:36
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, 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: STOMACH, GL (ST), STOMACH, NONGL (SU)
""Ik i
477
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 190
ANIMAL NUMBER: C96022
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEE K OF DEATH: 14
TERMINAL BODY WEIGHT: 264.4 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:09
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0765 2.0837 2.1627 8.7642
.1119 .5033 .2463 .0279
.0289 % .7881 % .8180 % 3.3147 % .0423 % .1904 % .0932 .0106 %
.0367 1.0000 1.0379 4.2061
.0537 .2415 .1182 .0134
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -MINIMAL
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
u
478
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 191
ANIMAL NUMBER: C96022
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
264.4 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:09
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU)
.T
479
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 192
ANIMAL NUMBER: C96023
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
253.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:06
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0695 2.0599 2.5238 10.5886
.1184 .5279 .3996 .0150
.0275 % .8142 % .9975 % 4.1852 % .0468 % .2087 % .1579 % .0059 %
.0337 1.0000 1.2252 5.1403
.0575 .2563 .1940 .0073
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE! 193
ANIMAL NUMBER: C96023
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:;: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 253.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:06
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
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)
481
APPENDIX 6 individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T--6314) IN RATS
PAGE: 194
ANIMAL NUMBER: C96024
SEX: FEMALE
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 12:12
POST--FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 3
SACRIFICE STATUS:
DEATH: 93
STUDY WEEK OF DEATH: 14
PROSECTOR: JODI THIEREN
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 257..7 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
O R GA N STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI)
OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/ PARATHYR
(TT)
.0753 2.1505 2.5361 8.6565
.1361 .4379 .2907 .0183
.0292 % .8345 % .9841 % 3.3591 % .0528 % .1699 % .1128 % .0071 %
.0350 1.0000 1.1793 4.0253
.0633 .2036 .1352 .0085
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
-.OTO J
482
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 195
ANIMAL NUMBER: C96024
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
257.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:12
PROSECTOR: JODI THIEREN
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM>, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU)
I if
03 483
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: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
253.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:33
PROSECTOR: KIMBERLY DURLAND
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0788 1.9934 2.3465 9.8976
.1407 .5995 .2171 .0268
.0310 % .7851 % .9242 * 3.8982 % .0554 % .2361 % .0855 % .0106 %
.0395 1.0000 1.1771 4.9652
.0706 .3007 .1089 .0134
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
STOMACH, GL (ST) : -LIGHT FOCUS(I)/AREA(S); MUCOSA, NEAR ESOPHAGEAL GROOVE: SINGLE WHITE PINPOINT SLIGHTLY RAISED FOCUS
LN, MANDIBULAR (MN) : -MOTTLED; BILATERAL: RED AND TAN
OVARY (OV) : -DIFFUSELY RED; BILATERAL
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
STOMACH, GL (ST) : UNREMARKABLE NOTE: THERE IS A FOCAL AREA OF NORMAL-APPEARING SKELETAL MUSCLE IN THE TUNICA MUSCULARIS IN THE REGION OF THE LIMITING RIDGE.
LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL
OVARY (OV) : UNREMARKABLE
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
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
253.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:33
PROSECTOR: KIMBERLY DURLAND
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE. STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL 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), S A L I V G L , 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)
(SM),
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, NONGL (SU)
I
oc s
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 2.0111 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
O S
T
RG A
1?A
N 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) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
r>
-3
'r * iv 05
P 486
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 199
ANIMAL NUMBER: C96026
SEX: FEMALE
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 11:08
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: 232.5 GRAMS
RECORDER: TERRI L. WILLIAMS 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)
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
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0659 1.9373 2.3111 9.8850
.1046 .5319 .3779 .0177
.0222 % .6527 % .7787 % 3.3305 % .0352 % .1792 % .1273 % .0060 %
.0340 1.0000 1.1929 5.1025
.0540 .2746 .1951 .0091
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATO C Y T E ,-MINIMAL
O r i-3
5
U
488
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 201
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
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 (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT|, CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU)
i*"S
0
to
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
ANIMAL NUMBER: C96028
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY W EEK OF DEATH: 14
TERMINAL BODY WEIGHT: 259.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 9:00
PROSECTOR: LAURIE J. SCHULLER
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI)
OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0628 1.9952 2.0909 8.7646
.1106 .5702 .3955 .0193
.0242 % .7686 % .8054 % 3.3762 % .0426 % .2196 % .1523 % .0074 %
.0315 1.0000 1.0480 4.3928
.0554 .2858 .1982 .0097
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL UPPER INCISORS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
o
CO
c/?
490
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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PAGE: 203
ANIMAL NUMBER: C96028
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS:
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:I: 93
STUDY WEEK OF DEATH: 14
DATE AND TIME OF NECROPSY: 12/02/98 9:00
PROSECTOR: LAURIE J. SCHULLER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 259.6 GRAMS
RECORDER: STEVE VAN ADESTINE WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM <SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU)
491
APPENDIX 6 individual Anatomic Pathology Data
Covance 6329-225 3m T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 204
ANIMAL NUMBER: C96029
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
239.5 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:41
PROSECTOR: NANCY DIEDRICH
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0817 1.9819 2.1671 8.7181
.1243 .5235 .2626 .0179
.0341 % .8275 % .9048 % 3.6401 % .0519 % .2186 % .1096 % .0075 %
.0412 1.0000 1.0934 4.3989
.0627 .2641 .1325 .0090
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL
0
CO
si
492
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 205
ANIMAL NUMBER: C 96029
SEX: FEMALE
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 7:41
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 3
SACRIFICE STATUS:
DEATH:I: 93
STUDY WEEK OF DEATH: 14
PROSECTOR: NANCY DIEDRICH
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 239.5 GRAMS
RECORDER: STEVE VAN ADESTINE 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 (J E ) , 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)
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: C96030
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
243.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:22
PROSECTOR: JODI THIEREN
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0640 2.0259 2.1625 10.3610
.1272 .5984 .2458 .0121
.0263 % .8317 % .8877 % 4.2533 % .0522 % .2456 % .1009 % .0050 %
.0316 1.0000 1.0674 5.1143
.0628 .2954 .1213 .0060
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
THYMUS (TH) : -RED FOCUS(I)/AREA(S); RIGHT LOBE: MULTIPLE PINPOINT FOCI
LN, MANDIBULAR <MN) : -DIFFUSELY RED; BILATERAL
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROS IS, COAGULATIVE,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL
1-3 CO
494
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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PAGE: 207
ANIMAL NUMBER: C96030
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 243.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:22
PROSECTOR: JODI THIEREN
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI), KIDNEY (KD) , HEART (HT) , MUSCLE, SKELETAL NERVE, SCIATIC (SN) , SPLEEN (SP) , LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORT E X (AC), ADRENAL, MEDULLA (MA), 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) , HARDER IAN GLAND (HG) , AUDITORY SEB GL (AS) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
(SM) ,
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU)
i"> 0
o
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
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 205.5 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:34
PROSECTOR: WENDY CHERRY
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
7.4421 -----------------------------
----------------------
3.6215 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN 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 (J E ) , 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)
r* 496
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 209
ANIMAL NUMBER: C96032
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT:
203.4 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:09
PROSECTOR: WENDY CHERRY
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
6.7736 -----------------------------
----------------------
3.3302 -----------------------------
%
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA), TAIL (TI) , GENERAL COMMENT (GC)
(T) 5
497
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 210
ANIMAL NUMBER: C96033
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS:
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
DATE AND TIME OF NECROPSY: 10/01/98 11:15
PROSECTOR: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 210.3 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)
----------------------
7.7835 ----------------------
--------
----------------------
3.7011 ----------------------
--------
%
--------------------------------------------------
--------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD) , HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP) , THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY) , PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC)
-5
Co
498
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 211
ANIMAL NUMBER: C96034
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS:
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
DATE AND TIME OF NECROPSY: 10/01/98 12:01
PROSECTOR: MATTHEW AXTMAN
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, FIRST INTERIM SACRIFICE TERMINAL BODY WEIGHT: 234.0 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)
----------------------
8.8195 -----------------------------
----------------------
3.7690 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) , CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF), URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC)
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
ANIMAL NUMBER: C96035
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 218.8 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:21
PROSECTOR: WENDY CHERRY
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
7.2747 -----------------------------
----------------------
3.3248 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NO N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
r*
Cfi 500
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 213
ANIMAL NUMBER: C96036
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
253.4 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 7:45
PROSECTOR: GREGORY CODDINGTON
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0611
2.1326 2.3286 9.7463
.1035 .4891 .3725 .0205
.0241 % .8416 % .9189 % 3.8462 % .0408 % .1930 % .1470 % .0081 %
.0287 1.0000 1.0919 4.5701
.0485 .2293 .1747 .0096
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL
{*> U
h &
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)
t
0
502
APPENDIX 6 Individual Anatomic Pathology Data
Covance G329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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 1.0000 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
G3 503
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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PAGE: 216
ANIMAL NUMBER: C96037
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS:
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
oSiTuUuDiY WVVE,EE,KA uOrF jDEATH: 14
DATE AND TIME OF NECROPSY: 12/02/98 7:37
PROSECTOR: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 251.1
RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER
GRAMS
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)
tr> 504
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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PAGE: 217
ANIMAL NUMBER: C96038
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH : 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT : 275..3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:14
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0554 2.1428 2.1681 9.8295
.1411 .4874 .2831 .0153
.0201 % .7784 % .7875 % 3.5705 % .0513 % .1770 % .1028 % .0056 %
.0259 1.0000 1.0118 4.5872
.0658 .2275 .1321 .0071
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OB SERVATIONS
HISTOPATHOLOGY
LN, MANDIBULAR (MN) : -DIFFUSELY RED ; BILATERAL
UTERUS (UT) : -LUMEN FILLED WITH FLUID;
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LEFT:
CLEAR
FLUID
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
LN, MANDIBULAR (MN) : -HEMORRHAGE,- SLIGHT
UTERUS (UT) : UNREMARKABLE
bo o
505
APPENDIX 6 individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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PAGE: 218
ANIMAL NUMBER: C96038
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
275.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:14
PROSECTOR: JERALD W. JOHNSON
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, N O N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU)
TOCTO3
506
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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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
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0835 2.0098 2.2091 9.1522
.1115 .4315 .3296 .0199
.0324 % .7805 % .8579 % 3.5543 % .0433 % .1676 % .1280 % .0077 %
.0415 1.0000 1.0992 4.5538
.0555 .2147 .1640 .0099
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
0 B S E R V A T I C )N S
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
Z02XV}
507
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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PAGE: 220
ANIMAL NUMBER: C96039
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
257.5 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:13
PROSECTOR: NANCY DIEDRICH
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
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)
" ) V
e
u
508
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 221
ANIMAL NUMBER: C96040
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
222.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:04
PROSECTOR: KIMBERLY DURLAND
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ADRENAL (AD) BRAIN (BR) KIDNEY <KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
ABSOLUTE ORGAN WEIGHT (GRAMS)
.0650 1.9359 2.3025 9.2333
.1810 .5292 .2778 .0253
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
.0292 % .8693 % 1.0339 % 4.1461 % .0813 % .2376 % .1247 % .0114 %
ORGAN TO BRAIN WEIGHT RATIO
.0336 1.0000 1.1894 4.7695
.0935 .2734 .1435 .0131
ORGAN STATUS
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
-0 T , j
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 222
ANIMAL NUMBER: C96040
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
222.7 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:04
PROSECTOR: KIMBERLY DURLAND
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL <SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), STOMACH, GL (ST), STOMACH, NONGL (SU)
C*-3
C/T
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
e
511
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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PAGE: 224
ANIMAL NUMBER: C96041
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:[: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 212.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:59
PROSECTOR: TODD ACKER
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR),
SPINAL CORD (SC), TRACHEA
(TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL(SM),
NERVE, SCIATIC(SN),
SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC),
ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA),
DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN),
SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) ,
CERVIX (CV), OVARY (OV), VAGINA (VA)
512
APPENDIX 6 Individual Anatomic Pathology Data
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, C H R O N I C ,-MINIMAL
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
STOMACH, GL (ST) : -EROSION,-MINIMAL
i-rs
**!S*
CO
Q 03
513
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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PAGE: 226
ANIMAL NUMBER: C96042
SEX: FEMALE
DOSE GROUP : 4
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 12:00
PROSECTOR: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 228.8
RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER
GRAMS
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
.1120 .4212 .2302 .0191
.0345 % .9235 % .9944 % 4.1887 % .0513 % .1929 % .1055 % .0087 %
.0374 1.0000 1.0768 4.5357
.0556 .2089 .1142 .0095
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
STOMACH, GL (ST) : -DARK FOCUS(I)/AREA(S); UP TO 4 X 2 MM
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
MUCOSA:
MULTIPLE
DARK
BROWN AREAS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
STOMACH, GL (ST) : -EROSION,-MINIMAL
-
vr
C:
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 NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU) , JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO) , RECTUM (RE) , LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
(SM),
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) ,MARROW, FEMUR (FM), MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), 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)
n>
U
t)
P P
516
APPENDIX 6 Individual Anatomie Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 229
ANIMAL NUMBER: C96044
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 261.0 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:19
PROSECTOR: TODD ACKER
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT {%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0833 2.1839 2.4878 14.4781
.1201 .5592 .2968 .0194
.0319 % .8367 % .9532 % 5.5472 % .0460 % .2143 % .1137 % .0074 %
.0381 1.0000 1.1392 6.6295
.0550 .2561 .1359 .0089
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
HEART (HT) : -DEGENERATION/NECROSIS, -MINIMAL
THYMUS (TH) : -HEMORRHAGE,-MINIMAL
CO f*
w
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 (J E ) , 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 (J E ) , 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)
r> 'r *
V*
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 W EEK 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
0B SERVATIONS
HISTOPATHOLOGY
OVARY (OV) : -DIFFUSELY RED; BILATERAL
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIO C Y T I C ,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTEI,-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:I: 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 (J E ) , 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)
W-3 cn
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
ANIMAL NUMBER: C96046
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
266.9 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:42
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%>
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0612 2.0991 2.2050 11.8714
.1311 .5352 .3266 .0186
.0229 % .7865 % .8262 % 4.4479 % .0491 % .2005 % .1224 % .0070 %
.0292 1.0000 1.0505 5.6555
.0625 .2550 .1556 .0089
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
-*%.
tr>
521
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 234
ANIMAL NUMBER: C96046
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:!: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT: 266.9 GRAMS
Da t e AND TIME OF NECROPSY: 12/02/98 10:42
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM) ,MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE,SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN) , SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
o
522
APPENDIX 6 Individual Anatomie Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 235
ANIMAL NUMBER: C96047
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
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
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0586 2.0822 2.3414 12.2355
.1156 .4873 .3388 .0191
.0275 % .9762 % 1.0977 % 5.7363 % .0542 % .2285 % .1588 % .0090 %
.0281 1.0000 1.1245 5.8762
.0555 .2340 .1627 .0092
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LIVER (LI) : -DIFFUSELY DARK; ALL LOBES: DARK BROWN
UTERUS (UT) : -LUMEN FILLED WITH FLUID;
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
BILATERAL: CLEAR FLUID
LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
UTERUS (UT) : -DILATATION,-SLIGHT
00 523
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 236
ANIMAL NUMBER: C96047
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
213.3 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:53
PROSECTOR: NANCY DIEDRICH
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY),BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , 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)
>\
to p
524
i
APPENDIX 6
Covance 6329-225
3M T-6314.1
j Individual Anatomic Pathology Data !
i
i
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 237
:'
t'
*
L)
(v
ANIMAL NUMBER: C96048
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
223.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:40
PROSECTOR: KIMBERLY DURLAND
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0851 2.1074 2.3036 13.9635
.1738 .5093 .2971 .0252
.0380 % .9416 % 1.0293 % 6.2393 % .0777 % .2276 % .1328 % .0113 %
.0404 1.0000 1.0931 6.6259
.0825 .2417 .1410 .0120
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
OVARY (OV) : -DIFFUSELY RED; BILATERAL: DARK RED
BRAIN (BR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
LUNG (LU) : -INFLAMMATION, SUBACUTE,-MINIMAL
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL,MINIMAL
KIDNEY (KD) : -MINERALIZATION, TUB U L A R ,-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), AO R T A (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
r>
p, Q *A CV
p
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
ANIMAL NUMBER: C96049
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
191.4 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:55
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STA T U S
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0539 1.8149 1.7670 10.6923
.0973 .4078 .2422 .0173
.0282 % .9482 % .9232 % 5.5864 % .0508 % .2131 % .1265 % .0090 %
.0297 1.0000
.9736 5.8914
.0536 .2247 .1335 .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 5 X 1 MM
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -TAIL - BENT/MISSING; TIP: MISSING; REMAINING PORTION COLLECTED
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -PIGMENT, HEPATOCELLULAR,-MINIMAL
STOMACH, GL (ST) : -EROSION,-SLIGHT
L)
to fO
527
APPENDIX 6 Individual Anatomic Pathology Data
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
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
191.4 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 10:55
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE,SKELETAL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
(SM),
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE),MARROW, FEMUR (FM),MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA)
Q
r:
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
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
216.8 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 11:40
PROSECTOR: GREGORY CODDINGTON
RECORDER: TERRI L. WILLIAMS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0634 2.0287 1.9598 12.8289
.0985 .3976 .1845 .0195
.0292 % .9357 % .9040 % 5.9174 % .0454 % .1834 % .0851 * .0090 %
.0313 1.0000
.9660 6.3237
.0486 .1960 .0909 .0096
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -P IGMENT, HEPATOCELLULAR,-MINIMAL
U'
t:
529
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 242
ANIMAL NUMBER: C96050
SEX: FEMALE
DATE OF DEATH: 12/02/98
STUDY DAY OF
DATE AND TIME OF NECROPSY: 12/02/98 11:40
POST-FIX WEIGHER: NOT AVAILABLE
DOSE GROUP: 4
SACRIFICE STATUS:
DEATH:!: 93
STUDY WEEK OF DEATH: 14
PROSECTOR: GREGORY CODDINGTON
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 216.8 GRAMS
RECORDER: TERRI L. WILLIAMS WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE,SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN),
.SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) ,MARROW, FEMUR (FM) ,MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT),MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , 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)
V
530
APPENDIX 6 Individual Anatomic Pathology Data
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
ANIMAL NUMBER: C96051
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT:
181.0 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:19
PROSECTOR: MATTHEW AXTMAN
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
8.8661 -----------------------------
----------------------
4.8984 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 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, NO N G L (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE) , 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)
k?
i:
531
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.I
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 244
ANIMAL NUMBER: C96052
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SACRIFICE
DATE OF DEATH: 10/01/98
STUDY DAY OF DEATH: 31
STUDY WEEK OF DEATH: 5
TERMINAL BODY WEIGHT: 202.7 GRAMS
DATE AND TIME OF NECROPSY: 10/01/98 11:52
PROSECTOR: WENDY CHERRY
RECORDER: KEVIN BILLINGS
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN ST A T U S
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP> THYMUS (TH) THYROID/PARATHYR
(TT)
----------------------
8.9691 -----------------------------
----------------------
4.4248 % -----------------------------
---------------------------------------------------------
NOT TAKEN NOT TAKEN NOT TAKEN WEIGHT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU) ,
PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC)
vi
532
APPENDIX 6 Individual Anatomic Pathology Data
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)
CO
7t f^t
00
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)
*\
*l
* V
CjD
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 (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB) , UTERUS (UT) , CERVIX (CV) , OVARY (OV) , VAGINA (VA) , TAIL (TI), GENERAL COMMENT (GC)
t: o
535
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: 248
ANIMAL NUMBER: C96056
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
209.3 GRAMS
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
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
u5
Q
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:1: 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
ANIMAL NUMBER: C96057
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
250.5 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 8:39
PROSECTOR: GREGORY CODDINGTON
RECORDER: STEVE VAN ADESTINE
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: TONY HANFELD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0614 2.1920 2.2779 13.2419
.1134 .3561 .2704 .0195
.0245 % .8750 % .9093 % 5.2862 %
.0453 % .1422 % .1079 % .0078 %
.0280 1.0000 1.0392 6.0410
.0517 .1625 .1234 .0089
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
STOMACH, GL (ST) : -DARK FOCUS(I)/AREA(S); MUCOSA: MULTIPLE BROWN AREAS, UP TO 3 X 1 MM
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN
'r*
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL
KIDNEY (KD) : -MINERALIZATION, TUBULAR,-MINIMAL
THYMUS (TH) : -INVOLUTION, -MINIMAL
STOMACH, GL (ST) : UNREMARKABLE
UTERUS (UT) : -DILATATION,-MINIMAL
Q
CO
538
APPENDIX 6 Individual Anatomic Pathology Data
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:
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH:[: 93
STUDY WEEK OF DEATH: 14
DATE AND TIME OF NECROPSY: 12/02/98 8:39
PROSECTOR: GREGORY CODDINGTON
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
SCHEDULED, TERMINAL SACRIFICE TERMINAL BODY WEIGHT: 250.5 GRAMS
RECORDER: STEVE VAN ADESTINE WEIGHER: TONY HANFELD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT) , MUSCLE, SKELETAL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU) , PANCREAS (PA), DUODENUM (DU), JEJUNUM (J E ) , ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI)
(SM),
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV) , OVARY (OV), VAGINA (VA)
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) : > N O T E :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
-*\ r*
540
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS
PAGE: 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), VAGI N A (VA)
u)
U
541
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: 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
UA CO Ci
v
542
APPENDIX 6 Individual Anatomic Pathology Data
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)
u>
U
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APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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PAGE: 256
ANIMAL NUMBER: C96060
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 12/02/98
STUDY DAY OF DEATH: 93
STUDY WEEK OF DEATH: 14
TERMINAL BODY WEIGHT:
249.6 GRAMS
DATE AND TIME OF NECROPSY: 12/02/98 12:19
PROSECTOR: MICHELE ZIMA
RECORDER: WENDY CHERRY
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: JOHN EIGHMY
WEIGHER: LYNN HORNER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
O RGAN STATUS
ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) OVARY (OV) SPLEEN (SP) THYMUS (TH) THYROID/PARATHYR
(TT)
.0718 2.0579 2.5943 13.5240
.1100 .4646 .3518 .0313
.0288 % .8245 % 1.0394 % 5.4183 % .0441 % .1861 % .1409 % .0125 %
.0349 1.0000 1.2607 6.5717
.0535 .2258 .1710 .0152
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
THYROID (TY) : >NOTE:TRIMMING COMMENT: ONE THYROID/PARATHYROID NOT FOUND IN WET TISSUE AT TRIMMING
PARATHYROID (PT) : >NOTE:>TRIMMING COMMENT: ONE THYROID/PARATHYROID NOT FOUND IN WET TISSUE AT TRIMMING
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT -ONE EXAMINED,-PRESENT
PARATHYROID (PT) : -ONE EXAMINED,-PRESENT
o -'*!
U.3 /' CO
544
APPENDIX 6 Individual Anatomic Pathology Data
Covance 6329-225 3M T-6314.1
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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
oSTx uUDu Yi WW EE jEr iKr t oOFr JDEATH: 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)
rs
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545
APPENDIX 7 Cell Proliferation Report
Covance 6329-225 3M T-6314.1
Note:
This appendix of the report contains information supplied by Pathology Associates International and has been reviewed by the Quality Assurance Unit of Pathology Associates International.
t '13 :1
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Covane* 6329-225 3M T-6314.1
Pathology Associates International
A Company of Science Applications International Corporation
FINAL CELL PROLIFERATION REPORT
13-WEEK 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
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TABLE OF CONTENTS I. CELL PROLIFERATION REPORT II. TABLES III. SIGNATURE PAGE IV. QUALITY ASSURANCE STATEMENT V. APPENDIX I
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Page 3
CELL PROLIFERATION REPORT
13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T-6314) IN RATS
COVANCE STUDY NUMBER 6329-225
PURPOSE
The purpose 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 D ietary 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 p o rtio n 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 U S 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 Ceil Proliferation
Five animals per sex per group in groups 1 through 4 w ere 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 PC N A (PAI'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 o f 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.
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Cell Proliferation Measurements
For cell proliferation evaluations, slides were first perused at low magnification (100X) to judge quality of 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 i-test (two-sided, unequal variance) was used to test for statistical significance in LI between control and treatment groups using M icrosoft 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 of the PCNA staining in this study.
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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 w eeks o f N -m ethyl perfluorooctanesulfonamido ethanol. Although cell proliferation was statistically less than controls in m id 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 was not considered to be biologically relevant.
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Page 6
II. 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 - 100 ppm) 4 (High - 100 ppm) 4 (High - 100 ppm) 4 (High - 100 ppm) 4 (High - 100 ppm)
Sex M M M M M
M M M M M
M M M M M
I
M M M M M
i
Animal
Number C95902 C95905 C95906 C95909 C95918
Mean
SEM C95924 C95925 C95927 C95936 C95937
Mean SEM C95942 C95947 C95948 C95950 C95958 Mean
SEM C95962 C95965 C95967 C95968 C95977
Mean SEM
PCNA
Labeling
Index (%) 0.387 0.246 0.227 0.153 0.583 0.319
0.076 0.190 0.208 0.235 0.063 0.224 0.184
(L031 0.162 0.160 0.186 0.065 0.160 0.147
0.021 0.130 0.163 0.881 0.096 0.162 0.286
0.149
Page 11-1
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C01348
Table 11-1. Cell Proliferation in Rat Liver
Covance 6329-225
Cova3nMceTS-6t3u1d4y.1No. 6329-225
I I
Dose Group 1 (Control - 0 ppm) 1 (Control - 0 ppm) 1 (Control - 0 ppm) 1 (Control - 0 ppm) 1 (Control - 0 ppm)
j Sex !F F
F F iF
----------- 1---
2 (Low - 3 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm) 2 (Low - 3 ppm)
F F iF F F
3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm) 3 (Mid - 30 ppm)
F F rF
F F
4 (High -100 ppm) 4 (High -100 ppm) 4 (High -100 ppm) 4 (High -100 ppm) 4 (High -100 ppm)
F rf
F F F
i
i
!
PC NA
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 i 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 j 0.121
C96049 j 0.152
C96056 ; 0.128
Mean ! 0.112
SEM
0.021
!!
11
Page II-2
554
o 3 / 13
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, PhJD Project Pathologist:
s '- /.'s '- n o Date
Carolyn Moyr, D.V.M., Diplomate, A.C.V.P. 555
C'01350
Covance 6329-225 3M T-6314.1
Final Cell ProliferationReport Covance Study Number 6329-225
Page 8
IV. QUALITY ASSURANCE STATEMENT
G0 1 3 5 1
556
Pathology Associates International A Company o f Science Applications International Corporation
covance 6329-225 3M T-6314.1
AnErnpoy^-OtmdCompany
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 U nit (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 of the recorded data. The following table is a record o f the inspections/audits performed and reported by the QAU.
D ate of Insnection
12/23/98 04/03/00
04/03/00 05/12/00
Phase Insnected
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
?<1- l /!LM Karen E. Butler Quality Assurance Officer
-5~ / / ck. Q C 2
Date
eo .13 r o
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 ProliferationReport Covance Study Number 6329-225
Page 9
APPENDIX I
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558
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 C96056 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 C01354
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
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