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Summary Report
104-Week Dietary Carcinogenicity Study with Narrow Range (98.1%) N-Ethyl Perfluorooctanesulfonamido Ethanol in Rats
PREPARED FOR: 3M
COVANCE STUDY NUMBERS: 6329-212 and-228
003113
SUMMARY REPORT - WEEK 53
104-Week Dietary Carcinogenicity Study with Narrow Range (98.1%) N-Ethyl Perfluorooctanesulfonamido Ethanol in Rats
Timelines Covance 6329-212:
In-life start date: January 26, 1998 Week 53 completed: January 31,1999
Covance 6329-228: In-life start date: April 6, 1998 Week 53 completed: April 11, 1999
Introduction The purpose of these studies was to assess the carcinogenicity of the test material, T-6316 (Narrow Range N-Ethyl Perfluooctanesulfonamido Ethanol, NEtFOSE), when administered in the diet to rats for at least 104 weeks. This summary report includes information through Week 53 and contains current findings; it is not, however, the final report for the study. Covance Laboratories Inc., reserves the right of review of these data before issuing the final report.
Methods Male and female Crl:CD(SD)IGS BR rats were assigned to groups according to the following design.
Group
No. of Animals
Male
Female
Dietary Levels * (ppm NEtFOSE)
Covance 6329-212
1 (Control)b 2 (Low) 3 (Mid) 4 (Mid-High) 5 (High) 6 (Mid-High Recovery) 7 (High Recovery)
70 70 60 60 60 60 70 70 70 70 40 40 40 40
0 3 30 100 300 100 300
Covance 6329-228
8 (Control) b 9 (Treated)
70 70 70 70
0 1
a T-6316 is 98.1% n-ethyl perfluorooctanesulfonamido ethanol (NEtFOSE); dose levels are expressed as ppm of NEtFOSE.
b The control animals received the basal diet only.
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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; findings were recorded as they were observed. At least once prior to treatment and weekly thereafter, each animal was removed from its cage and examined; abnormal findings or an indication of normal was recorded. Body weight data were recorded weekly for each animal for Weeks 1 through 17 and once every 4 weeks thereafter. Food consumption data were collected for each animal for Weeks 1 through 16 and once every 4 weeks thereafter. Body weights were also recorded for all animals in Groups 5 and 7 before sacrifice during Week 8.
Clinical Pathology. Blood and urine samples were collected for hematology, clinical chemistry, urinalysis, and urine chemistry from five animals/sex/group in Groups 1 and 5 during Week 8. Blood and urine samples were collected for hematology, clinical chemistry, urinalysis, urine chemistry, and serum sampling from 10 animals/sex/group in Groups 1 through 4 during Weeks 14, 27, and 53. Blood and urine samples were collected for hematology, clinical chemistry, urinalysis, and urine chemistry from 10 animals/sex/group from animals in Groups 8 and 9 during Weeks 14, 27, and 53. Animals were fasted overnight, and urine was collected chilled overnight (approximately 16 hours) before blood sampling. Blood was collected from a jugular vein. The anticoagulant was potassium EDTA for hematology tests. The samples for clinical chemistry and serum samples were collected without anticoagulant. The serum samples (that serum not used for clinical chemistry) were stored in a freezer set to maintain -60 to -80C, until shipped to the Sponsor for possible future analysis. When possible, a blood film was made for possible future examination from animals sacrificed at unscheduled intervals. A blood film was also made and held for possible future examination for animals at the scheduled sacrifice during Week 53.
Serum Analyses. Blood samples were collected for serum analyses from five animals/sex/group in Groups 1 through 5, 8, and 9 during Week 4; five animals/sex/group in Groups 1 and 5 during Week 8; five animals/sex/group in Groups 1 through 4, 8, and 9 during Week 14; and five animals/sex/group from Groups 1, 4, 8, and 9 during Week 53. Animals were fasted overnight. Blood (approximately 2 mL during Weeks 4, 8, and 14, and approximately 3 mL during Week 53) was collected from a jugular vein. Samples were collected without anticoagulant. Serum was harvested, stored in a freezer, set to maintain -60 to -80C, until sent to the Sponsor for possible future analyses.
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Termination. During Week 4, five animals/sex/group in Groups 1 through 5, 8, and 9 were fasted overnight, bled for serum samples, anesthetized with sodium pentobarbital (Groups 1 through 5) or carbon dioxide (Groups 8 and 9), weighed, and exsanguinated. The abdominal cavity of each animal was opened, the liver was removed and weighed, and liver samples were collected. Animals were discarded after liver collection.
During Week 8, five animals/sex/group in Groups 1 and 5 were fasted overnight, bled for clinical pathology and serum analyses, anesthetized with sodium pentobarbital, weighed, exsanguinated, and necropsied. At necropsy, macroscopic observations were recorded, selected organs were weighed, and selected tissues were collected and preserved. Additional liver samples were also collected. Adrenals, brain, eyes, kidneys, liver, mesenteric lymph node, pancreas, spleen, testes, and ovaries were processed and examined microscopically. The remaining animals in Groups 5 and 7 were euthanatized with carbon dioxide and discarded without necropsy.
During Week 14, five animals/sex/group in Groups 1 through 4 were fasted overnight, bled for clinical pathology and serum analyses, anesthetized with carbon dioxide, weighed, exsanguinated, and necropsied. At necropsy, macroscopic observations were recorded, selected organs were weighed, and selected tissues were collected and preserved. Additional liver samples were also collected. Adrenals, brain, eyes, kidneys, liver, mesenteric lymph node, pancreas, spleen, testes, and ovaries were processed and examined microscopically. Also during Week 14, five animals/sex/group in Groups 8 and 9 were fasted overnight, bled for clinical pathology and serum samples, anesthetized with carbon dioxide, weighed, and exsanguinated. The abdominal cavity of each animal was opened, the liver was removed and weighed, and liver samples were collected. Animals were discarded after liver collection.
During Week 53, five animals/sex from Group 1 and 10 animals/sex from Groups 4, 8, and 9 were fasted overnight, bled for clinical pathology and serum analyses (as appropriate), anesthetized with carbon dioxide, weighed, exsanguinated, and necropsied. At necropsy, macroscopic observations were recorded, selected organs were weighed, and selected tissues were collected and preserved. Additional liver samples were also collected. Tissues from each animal in Groups 1 and 4 were processed and examined microscopically.
Animals that died on test or were sacrificed at an unscheduled interval were also necropsied, but organ weights were not recorded and liver samples were not collected.
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Proliferation Cell Nuclear Antigen (PCNA) Evaluation. At the Week 4 sacrifice for animals in Groups 1 through 5 (five animals/sex/group), representative samples of the left lateral, right median, and right lateral lobes of the liver and any macroscopic lesions of the liver were collected and preserved in zinc formalin. At the Week 8 sacrifice for animals in Groups 1 and 5 (five animals/sex/group), representative samples of the left lateral lobe of the liver and any macroscopic lesions of the liver were collected and preserved in zinc formalin. At the Week 14 sacrifice for animals in Groups 1 through 4, 8, and 9 (five animals/sex/group), representative samples of the left lateral lobe of the liver and any macroscopic lesions of the liver were collected and preserved in zinc formalin. Liver samples were embedded, and blocks were sent to Pathology Associates International (PAI); PAI will evaluate the samples (left lateral lobe only) for PCNA. In addition, liver sections will be stained with hematoxylin and eosin and examined microscopically.
Mitochondrial Analyses. At the Week 4 sacrifice for animals in Groups 1 through 5 (five animals/sex/group), a sample (approximately 1.5 g) of the liver was collected from selected animals. Samples were placed on wet ice and transferred to the Sponsor for mitochondrial analysis.
Palmitoyl-CoA (PCoA) Oxidase Analyses. At the Week 4 sacrifice for animals in Groups 1 through 5, 8, and 9 (five animals/sex/group), a sample (approximately 500 mg) of the right lateral lobe of the liver was collected and flash-frozen in liquid nitrogen. At the Week 8 sacrifice for animals in Groups 1 and 5 (five animals/sex/group), a sample (approximately 500 mg) of the right lateral lobe of the liver was collected and flash-frozen in liquid nitrogen. At the Week 14 sacrifice for animals in Groups 1 through 4, 8, and 9 (five animals/sex/group), a sample (approximately 500 mg) of the right lateral lobe of the liver was collected and flash-frozen in liquid nitrogen. The samples were stored in a freezer, set to maintain -60 to -80C, until analyzed by Covance for PCoA oxidase activity.
Additional Liver Sample Collection. At the Week 4 sacrifice for animals in Groups 1 through 5, 8, and 9 (five animals/sex/group), a portion of the liver was stored in a freezer, set to maintain -60 to -80C, until sent to the Sponsor for possible future analysis. At the Week 8 sacrifice for animals in Groups 1 and 5 (five animals/sex/group), a portion of the liver was stored in a freezer, set to maintain -60 to -80C, until sent to the Sponsor for possible future analysis. At the Week 14 sacrifice for animals in Groups 1 through 4, 8, and 9 (five animals/sex/group), a portion of the liver was stored in a freezer, set to maintain -60 to -80C, until sent to the Sponsor for possible future analysis.
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Results Survival. Adjusted survival data are summarized in Tables 1 and 2.
Because of toxic effects seen for the body weights and food consumption at 300 ppm, the animals in Groups 5 and 7 were sacrificed early (during Week 8). For the remaining groups, survival after 53 weeks of treatment was 98.0%, 96.0%, 98.0%, 96.0%, 90.0%, 96.0%, and 96.0% for males in Groups 1, 2, 3, 4, 6, 8, and 9, respectively, and 98.0%, 100%, 98.0%, 96.0%, 100%, 92.0%, and 96.0% for females in Groups 1, 2, 3,4, 6, 8, and 9, respectively.
Clinical Observations. Clinical observation data are summarized in Tables 3 and 4.
There were no apparent test material-related observations noted through Week 53.
Body Weights. Body weight and body weight change data are summarized in Tables 5 through 8.
Animals given 100 or 300 ppm had significantly lower body weights compared to those of animals given the control material starting after the first week of treatment. Animals given 30 ppm had lower body weights compared to those of animals given the control material starting after the first week of treatment; however, they were not generally significant until approximately Week 8. There were no toxicologically meaningful significant body weight differences for animals given 1 or 3 ppm.
Animals given 300 ppm had significantly lower body weight changes compared to those of animals given the control material starting with the first week of treatment. Animals given 100 ppm had numerous significantly lower body weight changes compared to those of animals given the control material, and the overall body weight change (Week 1-53) was significantly lower than those of animals given the control material. Animals given 30 ppm had sporadic significantly lower body weight changes compared with those of animals given the control material, and the overall body weight change (Week 1-53) was significantly lower than those of animals given the control material. There were no toxicologically meaningful significant body weight change differences for animals given 1 or 3 ppm, and the overall body weight change (Week 1-53) was not significantly different than those of animals given the control material.
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Food Consumption. Food consumption data are summarized in Tables 9 and 10.
Animals given 100 or 300 ppm had significantly lower food consumption compared to those of animals given the control material starting with the first week of treatment. Males given 30 ppm had numerous significantly lower food consumption intervals compared to those of animals given the control material starting with Week 3. There were no toxicologically meaningful significant differences for females given 30 ppm or for animals given 1 or 3 ppm.
Test Material Consumption. Test material consumption data are summarized in Tables 11 and 12.
Animals were fed diets containing 0,1, 3, 30,100, and 300 ppm. The amount of test material consumed by animals on a mg/kg of body weight/day basis was as follows.
Target Dose Levels (ppm)
1 3 30 100 300 100 300
Achieved Dose Levels - Range
(mg/kg body weight/day)
Males
Females
0.036-0.103
0.049-0.108
0.108-0.259
0.147-0.307
1.126-2.618
1.454-3.070
3.847-8.724
5.686-10.166
16.058-25.408
19.568-28.712
3.841-8.873
5.355-10.135
15.803-25.193
20.004-29.270
Clinical and Anatomic Pathology. Hematology, clinical chemistry, urinalysis, and urine chemistry data are summarized in Tables 13 through 42. Terminal body weights, absolute organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios are summarized in Tables 43 through 49. Incidences of macroscopic and microscopic observations are summarized in Tables 50 through 59. Incidence of severity of selected microscopic observations is summarized in Tables 60 through 62.
The Pathology Report contains a discussion of the data.
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Dose Analyses. Results of the homogeneity, stability, and dose preparation analyses are in Tables 63 through 68.
Prestudy, several homogeneity analyses were conducted on each of several mixes in an attempt to resolve issues related to the inherent variability and lack of sufficient sensitivity at low levels in the analytical method for measuring NEtFOSE. Mean values of the homogeneity analyses for the mix done on January 15,1998, ranged from 89.7-104%, 92.0-98.7%, 86.8-98.4%, and 94.0-96.7% of the theoretical concentrations for the diets containing 3, 30, 100, and 300 ppm NEtFOSE, respectively. Mean values of the homogeneity analyses for the mix done on March 30,1998, ranged 91.3-106% of the theoretical concentrations for the diet containing 1 ppm NEtFOSE. 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 lower dietary concentrations.
Prestudy, several stability analyses were conducted on each of several mixes in an attempt to resolve issues related to the inherent variability and lack of sufficient sensitivity at low levels in the analytical method for measuring NEtFOSE. Results of stability analyses for the mix conducted on October 15,1997, of samples stored for 19 days at room temperature conditions indicated that the mean concentrations were 89.8 % and 87.5% of the initial concentrations of 3 ppm and 300 ppm respectively. Results of stability analyses for the mix conducted on October 15, 1997, of samples stored for 34 days at room temperature conditions indicated that the mean concentrations were 90.4 % and 89.6% of the initial concentrations of 3 ppm and 300 ppm respectively. Results of stability analyses for the mix conducted on October 15, 1997, of samples stored for 8 weeks under frozen conditions indicated that the mean concentrations were 89.2% and 95.3% of the initial concentrations of 3 ppm and 300 ppm respectively. Results of stability analyses for the mix conducted on June 5,1998, of samples stored 32 days at room temperature conditions indicated that the mean concentration was 77.9% of the initial concentration of 1 ppm. Results of stability analyses for the mix conducted on June 5,1998, of samples stored at room temperature for 46 days conditions for indicated that the mean concentration was 93.4% of the initial concentration of 1 ppm.
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The mean concentrations of the dose preparation analyses for all levels ranged from 61.8%-134% of the theoretical concentrations (including the reassay and retention sample analyses, but excluding data that required reanalysis). Inherent variability and lack of sufficient sensitivity at low levels in the analytical method for measuring NEtFOSE resulted in homogeneity, stability, and routine analyses data that were in many cases outside of the standard limits of 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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PATHOLOGY REPORT
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SUMMARY
The purpose of these studies was to assess the carcinogenicity of the test material, N-Ethyl Perfluorooctanesulfonamido Ethanol (NEtFOSE) when administered in the diet to rats for at least 104 weeks. The test material was administered at dose levels of 1, 3, 30, 100, and 300 ppm. Animals given 300 ppm were sacrificed during Week 8. This interim report discusses findings through the first 53 weeks of the study.
Dietary administration of NEtFOSE was associated with mildly decreased red blood cell count, hemoglobin, and hematocrit for females given 100 ppm; mildly lower glucose and mildly higher urea nitrogen for males and females given 100 ppm (predominantly at Weeks 14 and 27); moderately higher albumin and moderately lower globulin for males given 100 ppm (predominantly at Weeks 27 and 53); and moderately to markedly lower cholesterol for males given 30 or 100 ppm and females given 100 ppm. Administration of NEtFOSE at 1 or 3 ppm for approximately 52 weeks had no effects on clinical pathology test results.
At a dose level of 300 ppm for approximately 8 weeks, administration of NEtFOSE was associated with many effects on clinical pathology results including lower red blood cell count, hemoglobin, hematocrit, glucose, globulin, and cholesterol and higher urea nitrogen, albumin, total bilirubin (males only), aspartate aminotransferase (males only), alanine aminotransferase, and hepatic palmitoyl-CoA oxidase (also observed at Week 4). Most of the effects were moderate to marked in magnitude.
One male given 3 ppm, three males given 100 ppm, and four males given 300 ppm died on test or were sacrificed moribund. The male given 3 ppm was sacrificed due to a fracture of the hard palate. The cause of death was undetermined for one male given 100 ppm and one male given 300 ppm. All of the other animals that died or were sacrificed at unscheduled intervals had hepatocellular hypertrophy or hepatocellular necrosis due to treatment with the test material, or both. Hepatocellular necrosis was the cause of death for two males given 100 ppm and three males given 300 ppm.
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At the Week 4 sacrifice, terminal body weights were lower for males given 300 ppm, and absolute and relative liver weights were higher for males and females given 100 or 300 ppm. There were no gross findings at the Week 4 sacrifice, and tissues were not examined histologically.
At the Week 8 sacrifice, five animals/sex given 0 or 300 ppm were necropsied. Terminal body weights were lower and absolute and relative liver weights were significantly higher for males and females given 300 ppm. The only test material-related findings at necropsy were large livers for five males and two females given 300 ppm and mottling of the liver of one female given 300 ppm. Microscopically, test material-related findings were limited to the liver and consisted of hepatocellular hypertrophy, hepatocellular necrosis, and hemorrhage.
At the Week 14 sacrifice, terminal body weights were lower and absolute and relative liver weights were significantly higher for males and females given 100 ppm. There were no test material-related gross findings noted at necropsy. The only test material-related microscopic finding was hepatocellular hypertrophy for males given 30 or 100 ppm and females given 100 ppm.
At the Week 53 sacrifice, terminal body weights were lower and absolute and relative liver weights were significantly higher for males and females given 100 ppm. There were no test material-related gross findings noted at necropsy. Test material-related findings were limited to the liver and consisted of hepatocellular hypertrophy, vacuolation, necrosis, and bile stasis for animals given 100 ppm.
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METHODS
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Nine groups of Crl:CD(SD)IGS BR rats were studied using the following study design.
Group
No. of Animals
Male
Female
Dietary Levelsa (ppm NEtFOSE)
Covance 6329-212
1 (Control)b 2 (Low) 3 (Mid) 4 (Mid-High) 5 (High) 6 (Mid-High Recovery) 7 (High Recovery)
70 70 60 60 60 60 70 70 70 70 40 40 40 40
0 3 30 100 300 100 300
Covance 6329-228
8 (Control)b 9 (Treated)
70 70 70 70
0 1
a T-6316 is 98.1% n-ethyl perfluorooctanesulfonamido ethanol (NEtFOSE); dose levels are expressed as ppm of NEtFOSE.
b The control animals received the basal diet only.
During Week 8, blood and urine were collected for hematology, clinical chemistry, urinalysis, and urine chemistry tests from five animals/sex/group in Groups 1 and 5. During Weeks 14, 27, and 53, blood and urine were collected for these tests from 10 animals/sex/group in Groups 1 through 4, 8, and 9. Blood smears were made for all animals sacrificed at unscheduled intervals or during Week 53 (interim sacrifice).
Necropsies were performed on five animals/sex in Groups 1 and 5 sacrificed during Week 8; five animals/sex in Groups 1 through 4 sacrificed during Week 14; and five animals/sex in Group 1 and 10 animals/sex in Groups 4, 8, and 9 sacrificed during Week 53. At necropsy, macroscopic observations were recorded, organ weights were obtained (for sacrifices during Weeks 8, 14, and 53), and tissues were placed in fixative as specified by the protocol. At unscheduled necropsies for animals that died or were sacrificed because of poor health, macroscopic observations were recorded, and tissues were placed in fixative, but organ weights were not obtained. Microscopic examinations were done on selected tissues from animals in Groups 1 through 5 necropsied during Weeks 8 and 14. The tissues were adrenals, brain, eyes, kidneys, liver, mesenteric lymph node, pancreas, spleen, testes, and ovaries. Microscopic examinations were done on all collected tissues from animals in Groups land 4 necropsied at the Week 53 interim sacrifice.
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In addition, microscopic examinations were done on tissues from animals that died or were sacrificed due to poor health.
Five animals/sex in Groups 1 through 5 were sacrificed during Week 4, and five animals/sex in Groups 1 through 4 were sacrificed during Week 14 for hepatocellular proliferation rate measurements and hepatic palmitoyl-CoA oxidase activity. At the Week 4 collection for animals in Groups 1 through 5, samples of liver were collected for mitochondrial analysis. Five animals/sex in Groups 8 and 9 were sacrificed during Week 4 for hepatic palmitoyl-CoA oxidase activity and during Week 14 for hepatocellular proliferation rate measurements and hepatic palmitoyl-CoA oxidase activity.
Statistically significant differences cited in the Results and Discussion section are based on comparisons between the control and treated groups.
RESULTS AND DISCUSSION
Clinical Pathology Week 4. Males and females given 300 ppm had mildly, but statistically, higher hepatic palmitoyl-CoA oxidase activity consistent with peroxisomal proliferation.
Week 8. There were many statistically significant or otherwise notable differences for clinical pathology results between animals given the control material and animals given 300 ppm. Those differences considered to be effects of the test material were lower red blood cell count, hemoglobin, hematocrit, glucose, globulin, and cholesterol and higher urea nitrogen, albumin, total bilirubin (males only), aspartate aminotransferase (males only), alanine aminotransferase, and hepatic palmitoyl-CoA oxidase. With the exception of higher alanine aminotransferase for the females, these differences were statistically significant. The effects on the erythrocyte parameters, glucose, and globulin were consistent with poor health and failure to gain weight appropriately. Higher urea nitrogen and albumin were most consistent with mild dehydration and indicated the effects on other parameters (e.g., the erythrocyte parameters) would likely have been greater if the animals were normovolemic. The effects on alanine aminotransferase, aspartate aminotransferase, and total bilirubin were indicative of the hepatocellular degeneration and necrosis observed microscopically.
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Other statistically significant differences were considered to be of uncertain relationship to administration of the test material. Mildly lower platelet count was observed for males but not females. Absolute eosinophil count was statistically lower for both males and females, but the differences were extremely small as normal eosinophil count is very low.
Weeks 14,27, and 53. There were several statistically significant or otherwise notable differences for clinical pathology results between control and treated animals, Those differences considered to be effects of the test material were not always statistically significant but were generally consistent over time and exhibited a relationship to dose. Several statistically significant differences that were inconsistent over time or did not affect the high-dose group were considered incidental.
Administration of the test material was associated with decreased red blood cell count, hemoglobin, and hematocrit for females given 100 ppm; lower glucose and higher urea nitrogen for males and females given 100 ppm (predominantly at Weeks 14 and 27); higher albumin and lower globulin for males given 100 ppm (predominantly at Weeks 27 and 53); and lower cholesterol for males given 30 or 100 ppm and females given 100 ppm. These effects were consistent with those observed at Week 8 for animals given 300 ppm but were less prominent.
The effect of greatest magnitude was that for cholesterol. At the highest dose level, cholesterol was markedly decreased for the males. The erythrocyte effects and the effects on glucose and urea nitrogen were very mild, and the serum protein effects were considered of moderate severity.
Administration of the test material at 1 or 3 ppm for approximately 52 weeks had no effect on clinical pathology test results.
Anatomic Pathology Unscheduled Deaths. One Group 1 control male (Animal No. C90721) and one Group 1 control female (Animal No. C91179), two Group 2 males given 3 ppm (Animals Nos. C90806 and C90813), one Group 3 male given 30 ppm (Animal No. C90878), one Group 3 female given 30 ppm (Animal No. C91282), two Group 4 males given 100 ppm (Animals Nos. C90945 and C90949), one Group 4 female given 100 ppm (Animal No. C91322), three Group 5 males given 300 ppm (Animal Nos. C90993, C91003, and C91029), four Group 6 males given 100 ppm (Animal Nos. C91045, C91046, C91049,
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and C91068), one Group 7 male given 300 ppm (Animal No. C91099), two Group 8 control males (Animal Nos. C92198 and C92213), four Group 8 control females (Animal Nos. C92235, C92342, C92345, and C92347), two Group 9 males given 1 ppm (Animal Nos. C92273 and C92293) and two Group 9 females given 1 ppm (Animal Nos. C92403 and C92437) died on test or were sacrificed moribund.
Animal No. C90721, a Group 1 control male, died due to a widespread malignant lymphoma. Animal No. C90806, a Group 2 male given 3 ppm, was sacrificed because of a large subcutaneous undifferentiated sarcoma, and Animal No. C90813, a Group 2 male given 3 ppm, was sacrificed because it had a fracture of the hard palate. Animal No. C91003, a Group 5 male given 300 ppm, and Animal No. C91282, a female given 30 ppm, were sacrificed moribund with pituitary adenomas. Animals Nos. C91045, C91046, and C91068, Group 6 males given 100 ppm, and Animal No. C91099, a Group 7 male given 300 ppm, were sacrificed or died due to hepatic necrosis. Animal No. C91049, a Group 6 male given 100 ppm, died with necrosis of the musculature of the anus. Animal No. C91179, a Group 1 control female, was sacrificed because of a large mammary fibroadenoma. The cause of death was undetermined for the other Group 1 to 7 animals.
Histopathology was not done on the Group 8 and 9 animals. The macroscopic findings were typical of those observed in rats in long term studies.
Week 4 Sacrifice Organ Weights. Terminal body weights were lower for males given 300 ppm. Absolute and relative liver weights were higher for males and females given 100 or 300 ppm. There were no other test material-related changes for absolute organ weights, organ-to-body weight percentages or organ-to-brain weight ratios.
Macroscopic Findings. There were no gross findings noted at necropsy.
Week 8 Sacrifice Organ Weights. Terminal body weights were lower and absolute and relative liver weights were significantly higher for males and females given 300 ppm. There were no other test material-related changes for absolute organ weights, organ-to-body weight percentages, or organ-to-brain weight ratios.
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Macroscopic Findings. The only test material-related findings at necropsy were large livers for five males and two females given 300 ppm and mottling of the liver of one female given 300 ppm. There were no other test material-related gross findings noted at necropsy.
Microscopic Findings. Test material-related findings were limited to the liver. The test material-related hepatic findings were hepatocellular hypertrophy, hepatocellular necrosis, and hemorrhage. The incidence and severity of the hepatic lesions are listed in Text Table 1.
Text Table 1 Incidence and Severity of Test Material-Related Microscopic Findings
Males_____
Females
N-Ethyl Perfluorooctanesulfonamido (ppm)
Dose Level Number examined
f l 300 5
Q 300 51
Liver
Hypertrophy
Moderate 0
5
04
Moderately-severe 0
0
01
Necrosis
Minimal 0
1
00
Moderate 0
2
01
Hemorrhage
Minimal 0
3
00
Moderate 0
0
01
Week 14 Sacrifice Organ Weights. Terminal body weights were lower and absolute and relative liver weights were significantly higher for males and females given 100 ppm. There were no other test material-related changes for absolute organ weights, organ-to-body weight percentages, or organ-to-brain weight ratios.
Macroscopic Findings. There were no test material-related gross findings noted at necropsy.
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Microscopic Findings. The only test material-related finding was hepatocellular hypertrophy for males given 30 or 100 ppm and females given 100 ppm. The incidence and severity of the hepatocellular hypertrophy are listed in Text Table 2.
Text Table 2 Incidence and Severity of Hepatocellular Hypertrophy
Dose Level Number examined
Males_____
Females
N-Ethyl Perfluorooctanesulfonamido (ppm)
f l 3 20 100 Q 2 20 100 55 5 5 555 5
Liver Hypertrophy
Minimal Slight Moderate
00 1 0 000 0 00 1 4 000 2 00 1 1000 0
Week 53 Sacrifice Organ Weights. Terminal body weights were lower and absolute and relative liver weights were significantly higher for males and females given 100 ppm. There were no other test material-related changes for absolute organ weights, organ-to-body weight percentages, or organ-to-brain weight ratios.
Macroscopic Findings. There were no test material-related gross findings noted at necropsy.
Microscopic Findings. Hepatocellular hypertrophy and vacuolation of the liver were observed only for animals given 100 ppm. The incidence and severity of hepatocellular hypertrophy and vacuolation are listed in Text Table 3. Other test material-related hepatic findings were hepatocellular necrosis for one male and two females given 100 ppm and bile stasis for one male and two females given 100 ppm. One female given 100 ppm had a hepatocellular adenoma. Hepatocellular adenomas are occasionally observed as an incidental finding in 1 year old rats.
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Text Table 3 Incidence and Severity of Hepatocellular Hypertrophy
Dose Level Number examined
Males_____
Females
N-Ethyl Perfluorooctanesulfonamido (ppm)
0 3 30 100 3 20 100 5 0 0 10 5 0 0 10
Liver Vacuolation
Minimal Slight
Moderate
00 00 00
0 0 0
3 000 3 000 3 000
2 0 0
Hypertrophy Minimal Slight
Moderate Moderately Severe
00 0 00 0 00 0 00 0
0 000 3 000 2 000 5 000
0 3 4 0
17 G 0 C 3 0
C*1 c
Li
e
Table 1 Summary of Adjusted Survival Data
Covance 6329-212 3M T-6316.1
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN FATS DRAFT*
PAGE: 1
GROUP AND
DOSE LEVEL
(PPM)
WEEK: START
1
2
34
5
67
8
9 10 11
MALE
1 0 70/70 70/70 70/70 70/70 65/65 65/65 65/65 65/65 60/60 60/60 60/60 60/60
2 3 60/60 60/60 60/60 60/60 55/55 55/55 55/55 55/55 54/55 54/55 54/55 54/55
3 30 60/60 60/60 60/60 60/60 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55
4 100 70/70 70/70 70/70 70/70 65/65 65/65 65/65 65/65 65/65 65/65 65/65 65/65
5
300
70/70 70/70 70/70 70/70 65/65 65/65 65/65 63/65
0
0
0
0
6 100 40/40 40/40 40/40 40/40 40/40 40/40 40/40 39/40 39/40 39/40 39/40 39/40
7
300
40/40 40/40 40/40 40/40 40/40 40/40 39/40 39/40
0
0
0
0
Table 1 Summary of Adjusted Survival Data
Covance 6329-212 3M T-6316.1
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
PAGE: 2
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 12 13 14 15 16 17 18 19 20 21 22 23
0
2 3
3 30
4 100
O5 o 300 C*i
6 100
C-3
7 300
60/60
60/60
55/55
55/55
MALE 55/55
55/55
55/55
55/55
55/55
55/55
55/55
55/55
54/55 54/55 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50
55/55 55/55 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50
65/65 64/65 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60
0 0 000 000 000 0
38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40
0 0 000 000 000 0
Table 1 Summary of Adjusted Survival Data
Covance 6329-212 3M T-6316.1
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
PAGE: 3
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 24 25 26 27 28 29 30 31 32 33 34 35
cctroo
MALE
0 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55
2 3 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50 48/50
3 30 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50
4 100 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60
5 300 0 0 0 0 0 0 0 0 0 0 0 0
6 100 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40
7 300 0 0 0 0 0 0 0 0 0 0 0 0
Table 1 Summary of Adjusted Survival Data
Covance 6329-212 3M T-6316.1
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
PAGE: 4
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 36 37 38 39 40 41 42 43 44 45 46 47
0
2 3
3 30
4
100
e
o
5 300
6
u 100
7 300
55/55
55/55
55/55
55/55
MALE 55/55
55/55
55/55
55/55
54/55
54/55
54/55
54/55
48/50 48/50 48/50 48/50 48/50 48/50 48/50 48/50 48/50 48/50 48/50 48/50
50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50
59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 58/60 58/60 58/60
00 000 000 0 000
38/40 38/40 38/40 38/40 38/40 38/40 38/40 37/40 37/40 37/40 37/40 37/40
0 0 000000 000 0
rs t,c
CJ
m
Table 1 Summary of Adjusted Survival Data
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 48 49 50 51 52 53
HALE 1 0 54/55 54/55 54/55 54/55 54/55 49/50
2 3 48/50 48/50 48/50 48/50 48/50 48/50
3 30 50/50 50/50 50/50 50/50 50/50 49/50
4 100 58/60 58/60 58/60 58/60 58/60 48/50
5 300 0 0 0 0 0 0
6 100 37/40 37/40 37/40 36/40 36/40 36/40
7 300 0 0 0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 5
Table 1 Summary of Adjusted Survival Data
Covance 6329-212 3M T-6316.1
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
PAGE: 6
GROUP AND
DOSE LEVEL
(PPM)
WEEK: START
1
2
3
4
5
6
7
8
9 10 11
0
2 3
3 30
4 100
5 300
6 100
7 . 300
70/70
70/70
70/70
70/70
FEMALE 65/65
65/65
65/65
65/65
60/60
60/60
60/60
60/60
60/60
60/60
60/60
60/60
55/55
55/55
55/55
55/55
55/55
55/55
55/55
55/55
60/60 60/60 60/60 60/60 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55
70/70
70/70
70/70
70/70
65/65
65/65
65/65
65/65
65/65
65/65
65/65
65/65
70/70 70/70 70/70 70/70 65/65 65/65 65/65 65/65
0
0
0
0
40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40
40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40
0
0
0
0
Vi
c
C-*-
S-Jfc
b
Table 1 Summary of Adjusted Survival Data
Covance 6329-212 3M T-6316.1
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
PAGE: 7
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 12 13 14 15 16 17 18 19 20 21 22 23
FEMALE
0 60/60 60/60 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55
2 3 55/55 55/55 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50
3 30 55/55 55/55 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50
4 100 65/65 65/65 60/60 59/59 59/59 59/59 59/59 59/59 59/59 59/59 58/59 58/59
5 300 0 0 0 0 0 0 0 0 0 0 0 0
6 100 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40
7 300 0 0 0 0 0 0 0 0 0 0 0 0
Tabla 1 Summary of Adjusted survival Data
Covance 6329-212 3M T-6316.1
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
PAGE: 8
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 24 25 26 27 28 29 30 31 32 33 34 35
0
2 3
3 30
4 100
o5
300
c- 6
h* 100
o
m7
300
55/55
55/55
55/55
55/55
FEMALE 55/55
55/55
55/55
55/55
55/55
55/55
55/55
55/55
50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50
50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50
58/59
58/59
58/59
58/59
58/59
58/59
58/59
58/59
58/59
58/59
58/59
58/59
000000000000
40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40
000000000000
C C- C.J
Table 1 Summary of Adjusted Survival Data
Covance 6329-212 3M T-6316.1
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
PAGE: 9
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 36 37 38 39 40 41 42 43 44 45 46 47
FEMALE
0 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/55 54/55
2 3 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50
3
30
50/50
50/50
50/50
50/50
50/50
50/50
50/50
50/50
50/50
50/50
50/50
50/50
4 100 58/59 58/59 58/59 58/59 58/59 58/59 58/59 58/59 58/59 58/59 58/59 58/59
5 300 0 0 0 0 0 0 0 0 0 0 0 0
6 100 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40
7 300 0 0 0 0 0 0 0 0 0 0 0 0
Table 1 summary of Adjusted Survival Data
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 48 49 50 51 52 53
1 0
2 3
3 30
4 100 o e5
Ci 300
6 100 O
7 300
54/55
54/55
54/55
54/55
FEMALE 54/55
49/50
50/50 50/50 50/50 50/50 50/50 50/50
50/50 50/50 50/50 50/50 50/50 49/50
58/59 58/59 58/59 58/59 58/59 48/49
000000
40/40 40/40 40/40 40/40 40/40 40/40
000000
Covance 6329-212 3M T-6316.1
PAGE: 10
Table 2
Summary of Adjusted Survival Data
`DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 1
GROUP AND
DOSE LEVEL
(PPM)
WEEK: START
1
2
3
4
5
6
7
8
9 10 11
HALE 8 0 70/70 70/70 70/70 70/70 65/65 65/65 65/65 65/65 65/65 65/65 65/65 64/65
9 1 70/70 70/70 70/70 70/70 65/65 65/65 65/65 65/65 65/65 65/65 65/65 65/65
8
0
o
9 1
Ci
H*
i M
70/70
70/70
70/70
70/70
FEMALE 65/65
65/65
65/65
65/65
64/65
64/65
64/65
64/65
70/70 70/70 70/70 70/70 65/65 65/65 65/65 65/65 65/65 65/65 65/65 65/65
c
Table 2
Summary of Adjusted Survival Data
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 2
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 12 13 14 15 16 17 18 19 20 21 22 23
oo o 00 o
MALE
64/65 64/65 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60
9 1 65/65 65/65 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60
FEMALE
64/65 64/65 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60
9 1 65/65 65/65 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60
Table 2
Summary of Adjusted Survival Data
`DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 3
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 24 25 26 27 28 29 30 31 32 33 34 35
MALE 8
0 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60
9
1
60/60
60/60
60/60
60/60
60/60
60/60
60/60
60/60
60/60
60/60
60/60
60/60
8 0
o9 1
59/60
59/60
59/60
59/60
FEMALE 59/60
59/60
58/60
58/60
58/60
58/60
58/60
58/60
60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60
Table 2
Summary of Adjusted Survival Data
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 4
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 36 37 38 39 40 41 42 43 44 45 46 47
MALE 3 0 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60
9 1 60/60 60/60 60/60 60/60 60/60 60/60 58/60 58/60 58/60 58/60 58/60 58/60
8
0
e e9 c--. 1 h
58/60
58/60
58/60
58/60
FEMALE 58/60
58/60
58/60
58/60
58/60
58/60
58/60
58/60
60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60
Table 2
Summary of Adjusted Survival Data
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
GROUP AND
DOSE LEVEL
(PPM)
WEEK: 48 49 50 51 52 53
MALE 8 0 59/60 59/60 59/60 58/60 58/60 48/50
9 1 58/60 58/60 58/60 58/60 58/60 48/50
8 0
o9 o1 Ca
57/60
57/60
56/60
56/60
FEMALE 56/60
46/50
60/60 60/60 59/60 58/60 58/60 48/50
in
Covance 6329-228 3M T-6316.1
PAGE: 5
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
*** TOP OF LIST *** APPEARANCE
BENT TAIL CONVULSIONS DEHYDRATED HUNCHED MALOCCLUSION MISSING
TAIL-PROXIMAL <r% TEETH
PARALYSIS O ' LIMB-FRONT-LEFT
SWOLLEN LIMB-HIND-LEFT
s LIMB-HIND-RIGHT MOUTH
C l NOSE PAW-HIND-LEFT VENTRAL-ABDOMINAL THIN
BEHAVIOR HYPOACTIVE RECUMBENT LATERAL STERNAL
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP :
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-- MALE1234 5 67 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0000000 00002 00 0000001 00000 10 3 3 5 19 2 6 2
0000000 1013 0 00
0001010
1000000 0100000 0001010 0000000 0000000 0000010 0301111
0000111
0000010 1000000
Covance 6329-212 3M T-6316.1
PAGE: 1
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
BEHAVIOR SENSITIVE TO TOUCH VOCALIZATION
DISCHARGE
GENITAL
RED IN COLOR
6 C-5
ORAL RED IN COLOR CLEAR
I"* NASAL
RED IN COLOR
UNKNOWN
RED IN COLOR
EXCRETION DISCOLORED URINE RED IN COLOR ORANGE IN COLOR FEW FECES LIQUID FECES NO FECES NONFORMED FECES
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
--12 03
-- MALE34 5 67 30 100 300 100 300
70 60 60 70 70 40 40
1000000 0000100
1110020
0100001 0000010
0002140
0000100
1000000 1000000 1300021 0000010 1000010
5553020
Covance 6329-212 3M T-6316.1
PAGE: 2
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT*
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-MALE---12 34 5 67 0 3 30 100 300 100 300
70 60 60 70 70 40 40
EYES CLEAR DISCHARGE EYE-RIGHT EYES CLOUDY DISCHARGE EYE-RIGHT
OPAQUE f.; EYE-RIGHT
RED DISCHARGE EYE-LEFT EYE-RIGHT EYES
SQUINTED PERI-ORBITAL
HOUSING,FOOD,WATER & MAINT. TEETH CUT
RESPIRATION AUDIBLE IRREGULAR LABORED
SKIN & PELAGE ALOPECIA
0000000 1000000 0000000 0000000 1020030 0101000 2101030 0000000
1000000
0 1 0 10 00 0100020 0 1 0 01 10
0000000
Covance 6329-212 3M T-6316.1
PAGE: 3
fV--<-, (3
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
SKIN & PELAGE BROWN HAIR COAT PERINEAL AREA SCROTUM VENTRAL-ABDOMINAL BLUE SKIN VENTRAL-ABDOMINAL- RIGHT COLD TO TOUCH ENTIRE BODY PALE EARS
entire body
RED HAIR COAT HEAD-ENTIRE HEAD-CRANIAL LIMBS-ALL VENTRAL-ABDOMINAL
ROUGH HAIR COAT SCALY SKIN
TAIL-DISTAL SORE/SCAB
AXILLARY REGION-RIGHT DORSAL DORSAL-CERVICAL DORSAL-CERVICAL-LEFT DORSAL-CERVICAL-RIGHT
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-- MALE1234 5 67 0 3 30 100 300 100 300
70 60 60 70 70 40 40
1100000 0001000 0001010
0000000
0000100
0000000 1100100
0200100 0000000 0100000 0100001 0101010
0000000
0000000 1000000 1000000 0000000 0010000
Covance 6329-212 3M T-6316.1
PAGE: 4
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
--MALE123 4 567 0 3 30 100 300 100 300
70 60 60 70 70 40 40
SKIN & PELAGE
SORE/SCAB
EAR-RIGHT
HEAD-ENTIRE
HEAD-CRANIAL
HEAD-MAXILLARY-RIGHT
LATERAL-ABDOMINAL-RIGHT
LATERAL-CERVICAL-LEFT o LATERAL-CERVICAL-RIGHT
LIMB-HIND-LEFT LIMB-HIND-RIGHT
LIMBS-HIND
H - MOUTH
Ci
PAW-HIND-LEFT PAW-HIND-RIGHT
O PAWS-FRONT
PAWS-HIND
SHOULDER-LEFT
SHOULDER-RIGHT
TAIL
VENTRAL-ABDOMINAL
VENTRAL-ABDOMINAL-LEFT
VENTRAL-ABDOMINAL-RIGHT
VENTRAL-CERVICAL
VENTRAL-CERVICAL-LEFT
VENTRAL-CERVICAL-RIGHT
0010000 0000001 0100000 0011000 0100000 1000000 1000000
0010000 0100000 1000000 0000000 1111010 0211010 0000000 1101010 0210000 0000000 1100000 0011010 0100000 0000000 1100110 0010000 0010000
Covance 6329-212 3M T-6316.1
PAGE: 5
003151
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
SKIN * PELAGE
YELLOW HAIR COAT
MASS(ES) AXILLARY REGION-LEFT WEEK 26 WEEK 33 WEEK 43 WEEK 47 AXILLARY REGION-RIGHT WEEK 31 WEEK 35 WEEK 38 WEEK 45 WEEK 47 WEEK 48 WEEK 52 DORSAL WEEK 49 HEAD-MAXILLARY-RIGHT WEEK 17 WEEK 48 WEEK 51
Table 3 Summary of clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-MALE1234 567 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0000011
0000000 0000000 1000000 0000000
0000000 0000000 0000000 0000000 0000000 0000000 0000000
1000000
0000000 0000000 0100000
Covance 6329-212 3M T-6316.1
PAGE: 6
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
MASS(ES) LIMB-HIND-LEFT WEEK 25 MOUTH WEEK 20 SHOULDER-LEFT WEEK 40 VENTRAL-ABDOMINAL WEEK 33 WEEK 35 WEEK 40 WEEK 44 WEEK 49 WEEK 51 VENTRAL-ABDOMINAL- LEFT WEEK 21 WEEK 22 WEEK 37 WEEK 45 WEEK 46 WEEK 49 WEEK 51 WEEK 53 VENTRAL-ABDOMINAL-RIGHT WEEK 29 WEEK 32
Table 3 Summary of Clinical observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-MALE12 34 5 67 0 3 30 100 300 100 300
70 60 ' 60 70 70 40 40
0000000
1000000
0010000
0000000 0000000 0000000 0000000 0000000 0000000
0100000 0000000 0001000 0000000 0000000 0000000 0100000 0000000
0001000 0000000
Covance 6329-212 3M T-S316.1
PAGE: 7
esTPoo
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
MASS (ES) VENTRAL-ABDOMINAL-RIGHT WEEK 36 WEEK 38 WEEK 40 WEEK 49 WEEK 51 WEEK 53 VENTRAL-CERVICAL-LEFT WEEK 43 WEEK 46 WEEK 48 VENTRAL-CERVICAL-RIGHT WEEK 43 VENTRAL-THORACIC WEEK 42
WART LIKE LESION(S) DORSAL WEEK 47 WEEK 51 EAR-LEFT WEEK 47 MOUTH WEEK 21 WEEK 23
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP :
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-- MALE12 34 567 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0000000 0001000 0000000 0000000 0000000 0000000
00 0 0 0 00 0000000 0000000
0000000
1000000
0100000 1000000
01 00 0 00
0000000 0000000
Covance 6329-212 3M T-6316.1
PAGE: 8
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
WART LIKE LESION(S)
MOUTH
WEEK 31
WEEK 52
PAW-HIND-RIGHT
WEEK 34
e SHOULDER-LEFT
e
WEEK 37 TAIL
c,< WEEK 19
WEEK 22
VENTRAL-THORACIC
WEEK 46
END OF LIST
Table 3 Sununary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
--MALE1234 567 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0000000 0000000
0100000
0010000
0100000 0120000
0000000
Covance 6329-212 3M T-6316.1
PAGE: 9
ssiroo
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
*** TOP OF LIST *** APPEARANCE
BENT TAIL CONVULSIONS DEHYDRATED HUNCHED MALOCCLUSION MISSING
TAIL-PROXIMAL TEETH PARALYSIS LIMB-FRONT-LEFT SWOLLEN LIMB-HIND-LEFT LIMB-HIND-RIGHT MOUTH NOSE PAW-HIND-LEFT VENTRAL-ABDOMINAL THIN
BEHAVIOR HYPOACTIVE RECUMBENT LATERAL STERNAL
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ` DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-FEMALE--1234 5 67 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0000010 0010000 0000000 0001000 5 9 6 13 0 6 0
0000010 0 0 0 0 0 00
0000000
0000000 0000000 0000000 0000010 0001000 0000000 1001010
0010000
0000000 0000000
Covance 6329-212 3M T-6316.1
PAGE: 10
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
BEHAVIOR SENSITIVE TO TOUCH VOCALIZATION
DISCHARGE
o GENITAL
c Ci
RED IN COLOR
ORAL RED IN COLOR
h CLEAR in NASAL
RED IN COLOR
a UNKNOWN
RED IN COLOR
EXCRETION DISCOLORED URINE RED IN COLOR ORANGE IN COLOR FEW FECES LIQUID FECES NO FECES NONFORMED FECES
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-FEMALE--1234 5 67 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0001000 0000000
00 0 1 02 0
0001000 0000000
1113010
0000000
0000000 0000000 0011000 0000000 0001010 2000000
Covance 6329-212 3M T-6316.1
PAGE: 11
6(T->
C*-*
VI
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
EYES CLEAR DISCHARGE EYE-RIGHT EYES CLOUDY DISCHARGE EYE-RIGHT OPAQUE EYE-RIGHT RED DISCHARGE EYE-LEFT EYE-RIGHT EYES SQUINTED PERI-ORBITAL
HOUSING, FOOD, WATER & MAINT. TEETH CUT
RESPIRATION AUDIBLE IRREGULAR LABORED
SKIN & PELAGE ALOPECIA
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-FEMALE--12345 67 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0000010 0000000 1000000 0000010 1210010 0100020 0111000 0010000
0000010
0012000 0000000 00l0000
0002010
Covance 6329-212 3M T-6316.1
PAGE: 12
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT*
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
SEX: GROUP :
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-FEMALE--1234 5 67 0 3 30 100 300 100 300
70 60 60 70 70 40 40
SKIN t PELAGE
BROWN HAIR COAT
PERINEAL AREA
SCROTUM
VENTRAL-ABDOMINAL
BLUE SKIN
r s VENTRAL-ABDOMINAL-RIGHT
COLD TO TOUCH ENTIRE BODY
C- PALE
EARS
ENTIRE BODY
fc1 RED HAIR COAT
m
HEAD-ENTIRE HEAD-CRANIAL
LIMBS-ALL
VENTRAL-ABDOMINAL
ROUGH HAIR COAT
SCALY SKIN
TAIL-DISTAL
SORE/SCAB
AXILLARY REGION-RIGHT
DORSAL
DORSAL-CERVICAL
DORSAL-CERVICAL-LEFT
DORSAL-CERVICAL-RIGHT
0010000 0000000 0001000
0010000
1000000
0100000 1101010
0000000 0000010 0000000 0000000 0002040
0001000
0100000 0001000 0000000 1000000 0000000
Covance 6329-212 3M T-6316.1
PAGE: 13
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
o
f* m
SKIN & PELAGE SORE/SCAB EAR-RIGHT HEAD-ENTIRE HEAD-CRANIAL HEAD-MAXI LLARY-RIGHT LATERAL-ABDOMINAL-RIGHT LATERAL-CERVICAL-LEFT LATERAL- CERVICAL- RIGHT LIMB-HIND-LEFT LIMB-HIND-RIGHT LIMBS-HIND
MOUTH PAW-HIND-LEFT PAW-HIND-RIGHT PAWS-FRONT PAWS-HIND SHOULDER-LEFT SHOULDER- RIGHT TAIL VENTRAL-ABDOMINAL VENTRAL-ABDOMINAL-LEFT VENTRAL-ABDOMINAL-RIGHT VENTRAL-CERVICAL VENTRAL-CERVICAL-LEFT VENTRAL-CERVICAL-RIGHT
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-- FEMALE--1234 567 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0 0 0 0
00 0
00 000 00
00000 0 0
0000 011
0 0 0 0
00 0
0100 00 0
0 0 0 0
00 0
0000000
0000000
0000000
0
0 0
0 0
0 0
0 0
0
10
0
0
001 100 1000 1011
00 0 000 00000 0
2
1
20 10 10 0000 0 10 0
0 0
0 0
0 0
0 0 0 0
0 0
0
0
00 00 10 0 0000010
0 0
0
0 0
0
0 0 0 0
0 0
0 0
Covance 6329-212 3M T-6316.1
PAGE: 14
ooaiG o
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
SKIN & PELAGE YELLOW HAIR COAT
M A S S (E S } AXILLARY REGION-LEFT WEEK 26 WE E K 33 W EEK 43 W EEK 47 AXILLARY REGION-RIGHT WEEK 31 WEEK 35 WEEK 38 WEEK 45 WEEK 47 WEEK 48 W E E K 52 DORSAL W EEK 49 HEAD-MAXILLARY-RIGHT W E E K 17 WEEK 48 W EEK 51
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
- F E M A L E ---12 3 4 5 67 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0 00 1000
10 00000 00 10000 00 10000 01 00000
00 10000 01 00000 22 00000 00 01000 1 0 00000 00 01000 0021000
0 0 00000
00 01000 00 01000 0000000
Covance 6329-212 3M T-6316.1
PAGE: 15
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
M A S S (ES) LIMB-HIND-LEFT WEEK 25 MOUTH WEEK 20 SHOULDER-LEFT WEEK 40 VENTRAL-ABDOMINAL WEEK 33 WEEK 35 WEEK 40 WEEK 44 WEEK 49 WEEK 51 VENTRAL-ABDOMINAL- LEFT WEEK 21 WEEK 22 WEEK 37 WEEK 45 WEEK 46 WEEK 49 WEEK 51 WEEK 53 VENTRAL-ABDOMINAL-RIGHT WEEK 29
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX: GROUP :
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-FEMALE--12 3 4 5 67 0 3 30 100 300 100 300
70 60 60 70 70 40 40
1000000
0000000
0000000
0001000 02 0 0 01 0 0100000 0000010 0100000 1100000
0000000 0010000 0000000 1000000 0100010 0100000 0000010 0010000
0000000
Covance 6329-212 3M T-6316.1
PAGE: 16
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
MASS(ES) VENTRAL-ABDOMINAL-RIGHT WEEK 36 WEEK 38 WEEK 40 WEEK 49 WEEK 51 WEEK 53 VENTRAL-CERVICAL-LEFT WEEK 43 WEEK 46 WEEK 48 VENTRAL- CERVICAL-RIGHT WEEK 43 VENTRAL-THORACIC WEEK 42
WART LIKE LESION(S) DORSAL WEEK 47 WEEK 51 EAR-LEFT WEEK 47 MOUTH WEEK 21 WEEK 23
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-FEMALE--12 34 567 0 3 30 100 300 100 300
70 60 60 70 70 40 40
1000000 0010000 00 10 000 0100000 1011010 0010000
0000010 0010000 0000010
0001000
0000000
0000000 0000000
0000000
1000000 0001000
Covance 6329-212 3M T-6316.1
PAGE: 17
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
WART LIKE LESION(S)
MOUTH
WEEK 31
WEEK 52
PAW-HIND-RIGHT
WEEK 34
o
SHOULDER-LEFT WEEK 37
o TAIL
C-<
WEEK 19 WEEK 22
M VENTRAL-THORACIC
a CJ
WEEK 46 *** END OF LIST ***
Table 3 Summary of Clinical Observations
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP:
DOSE:
NUMBER:
NUMBER OF ANIMALS AFFECTED
-FEMALE--12 34 567 0 3 30 100 300 100 300
70 60 60 70 70 40 40
0001000 0100000
0000000
0000000
0000000 0000000
0010000
Covance S329-212 3M T-6316.1
PAGE: 18
s
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
*** TOP OF LIST ***
APPEARANCE
HUNCHED
MALOCCLUSION
MISSING
TEETH
PARALYSIS
LIMB-FRONT-LEFT
SWOLLEN
O
MOUTH THIN
o
C-* H-
BEHAVIOR AGGRESSIVE UNSPECIFIED
cn MODERATE
ATftXTC
it* <UNSPECIFIED
HYPOACTIVE
UNSPECIFIED
SENSITIVE TO TOUCH
COLD TO TOUCH
ENTIRE BODY
DISCHARGE GENITAL RED IN COLOR
Table 4
Summary of Clinical Observations
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
NUMBER OF ANIMALS AFFECTED
SEX: GROUP:
DOSE:
-- MALE-- 89 01
-FEMALE' 89 01
NUMBER: 70 70 70 70
0100 10 4 13 8
0100
0100
0010 0121
0100 0100
0001
1000 0101
1000
0201
Covance 6329-228 3M T-6316.1
PAGE: 1
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
DISCHARGE CLEAR ORAL MODERATE NASAL RED IN COLOR MUCOID FROM RECTUM
EXCRETION
o
FEW FECES NO FECES
O ' NONFORMED FECES
C EYES DISPLACED PUPIL
s EYE-RIGHT RED DISCHARGE
o EYE-LEFT EYE-RIGHT EYES
SQUINTED
PERI-ORBITAL
RESPIRATION AUDIBLE LABORED
Table 4
Summary of Clinical Observations
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
NUMBER OF ANIMALS AFFECTED
SEX: GROUP:
DOSE:
--MALE-- 89 01
-FEMALE 89 01
NUMBER: 70 70 70 70
0 10
0
0031 0 0 10
10 10 0 1 0 0
67 0 0
0 0 10
00 12 11 13 1111
0 00 1
10 10
0 0 10
Covance 6329-228 3M T-6316.1
PAGE: 2
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
c
to
.Ht CD
/u9S
SKIN & PELAGE ALOPECIA BLUE SKIN VENTRAL-ABDOMINAL-LEFT PALE ENTIRE BODY RED HAIR COAT DORSAL HEAD-ENTIRE RED SKIN TAIL SORE/SCAB DORSAL DORSAL-CERVICAL HEAD-ENTIRE
HEAD-CRANIAL HEAD-MAXILLARY-LEFT LATERAL-CERVICAL-LEFT LUMBAR-RIGHT MOUTH SCROTUM SHOULDER-RIGHT VENTRAL-ABDOMINAL
VENTRAL-ABDOMINAL-LEFT VENTRAL-ABDOMINAL-RIGHT VENTRAL-CERVICAL
Table 4
Summary of Clinical Observations
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANES0LFONAMIDO ETHANOL IN RATS
NUMBER OF ANIMALS AFFECTED
SEX: GROUP:
DOSE:
-MALE-
89 01
-FEMALE-
89 01
NUMBER: 70 70 70 70
0010
0001
0010
0001 2010
1000
0001 1 100 001 0 0001 0010 0001 1 0 00 01 00 1 000 0010 21 00 2 1 00 1 1 00 0010
Covance 6329-228 3M T-6316.1
PAGE: 3
9 T ro o
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
SKIN A PELAGE YELLOW HAIR COAT
MASS(ES) AXILLARY REGION-LEFT WEEK 42 WEEK 45 WEEK 48 WEEK 51 AXILLARY REGION-RIGHT WEEK 28 WEEK 39 WEEK 40 WEEK 42 INGUINAL REGION-LEFT WEEK 48 INGUINAL REGION-RIGHT WEEK 35 WEEK 40 WEEK 42 LIMB-FRONT-RIGHT WEEK 35
Table 4
Summary of Clinical Observations
`DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
NUMBER OF ANIMALS AFFECTED
SEX: GROUP:
DOSE:
-- MALE-- 89
01
-FEMALE 89 01
NUMBER: 70 70 70 70
0120
0001 0010 0001 0002
0001 0001 0010 0011
0001
0001 0001 0001
0001
Covanee 6329-228 SM T-6316.1
PAGE: 4
o f;
Ct m
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
MASS(ES) PAW-HIND-RIGHT WEEK 42 SHOULDER-LEFT WEEK 38 SHOULDER-RIGHT WEEK 19 VENTRAL*ABDOMINAL WEEK 32 WEEK 35 WEEK 40 WEEK 44 WEEK 45 WEEK 50 VENTRAL-ABDOMINAL-LEFT WEEK 28 WEEK 34 WEEK 40 WEEK 44 WEEK 46 WEEK 49 WEEK 50 WEEK 51 VENTRAL-ABDOMINAL-RIGHT WEEK 28 WEEK 33
Table 4
Summary of Clinical Observations
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
NUMBER OF ANIMALS AFFECTED
SEX: GROUP:
DOSE:
-- MALE-- 89 01
-FEMALE 89 01
NUMBER: 70 70 70 70
0001
0010
0010
1000 0001 0100 0002 0100 0011
1000 0001 1000 0021 0100 0020 0021 0 02 0
1000 1000
Covance 6329-228 3M T-6316.1
PAGE: 5
DAYS 1-371
CATEGORY KEYWORD QUALIFIER
MASS(ES) VENTRAL-ABDOMINAL-RIGHT WEEK 40 WEEK 44 WEEK 45 WEEK 48 WEEK 51 WEEK 53 VENTRAL-CERVICAL
e WEEK 36 WEEK 46
VENTRAL-CERVICAL-LEFT 4 WEEK 31
WEEK 38
a WART LIKE LESION(S)
DORSAL WEEK 41
NOSE WEEK 46
VENTRAL-ABDOMINAL WEEK 20
*** END OF LIST ***
Table 4
Summary of Clinical Observations
`DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
NUMBER OF ANIMALS AFFECTED
SEX: GROUP:
DOSE:
-- MALE-- 89 01
-FEMALE 89 01
NUMBER: 70 70 70 70
0001 0001 0001 0100 0010 0020
0010 0020
0 0- 1 0 0001
1000
0010
1000
Covance 6329-228 3M T-6316.1
PAGE: 6
Table 5 Summary of Body Weight Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX:
--- MALE----
GROUP:
1
2
3
4
5
6
7
DOSE:
0
3 30 100 300 100 300
WEEK UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
1N
70
MEAN
261
S.D.
20.4
60 260
19.9
60 260
20.5
70 258
19.2
69 257
19.0
40 254
17.8
40 256
19.2
2N
70
MEAN
308
S.D.
23.1
60 307
22.5
60 302
24.5
70 298*
21.7
70 288*
23.0
40 296*
20.0
40 286*
21.2
3N
70
MEAN
350
S.D.
25.7
4N
70
MEAN
387
S.D.
29.0
60 351
26.6
60 389
29.9
60 344
29.9
60 379
34.8
70 337*
25.3
70 367*
28.3
70 318*
25.9
70 338*
28.8
40 334*
24.2
40 364*
27.8
40 313*
24.0
40 334*
27.3
5N
65
55
55
65
64
40
40
MEAN
417
416
404
393*
355*
391*
351*
S.D.
31.5
31.5
38.2
30.5
31.8
32.5
30.3
O
. 6 N
65
55
55
65
65
40
40
MEAN
444
444
431
418*
370*
416*
366*
S.D.
33.6
33.9
40.5
33.6
35.3
36.2
33.1
7N
65
55
55
65
65
40
39
MEAN
467
467
450
436*
380*
427*
374*
S.D.
37.0
37.1
42.6
35.5
37.6
42.8
33.9
Covance 6329-212 3M T-6316.1
PAGE: 1
SEX: GROUP:
DOSE: WEEK UNITS:
1 0 PPM
8N
65
MEAN
483
S.D.
39.5
9N
60
MEAN
504
S.D.
43.4
10 N
60
MEAN
521
S.D.
45.1
11 N
60
MEAN
532
S.D.
45.4
12 N
60
MEAN
543
O
S.D.
46.8
13 N
60
c<
MEAN
553
S.D.
47.7
14 N
60
MEAN
563
S.D.
50.1
Table 5 Summary of Body Weight Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
--- MALE---2345 67 3 30 100 300 100 300
PPM PPM PPM PPM PPM PPM
55 480
40.0
54 507
40.2
54 524
41.1
54 537
43.3
54 550
44.6
54 559
48.3
54 567
48.0
55 464*
43.4
55 483*
45.9
55 497*
49.3
55 510*
49.8
55 522
51.5
55 531
52.7
55 538*
54.5
65 449*
39.4
65 465*
40.9
65 477*
41.8
65 486*
43.7
65 496*
46.9
65 504*
51.2
64 513*
45.3
63 386*
42.4 0
0
0
0
0
0
39 448*
44.8
39 464*
51.0
39 473*
57.6
39 484*
62.4
39 496*
64.9
38 515*
44.9
38 522*
45.5
39 384*
38.5 0
0
0
0
0
0
Covance 6329-212 3M T-6316.1
PAGE: 2
Table 5 Summary of Body Weight Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX: -------------------------------------- MALE
GROUP:
1
2
3
4
DOSE:
0
3 30 100
WEEK UNITS:
PPM
PPM
PPM
PPM
15 N
55
MEAN
569
S.D.
51.8
16 N
55
MEAN
578
S.D.
52.9
17 N
55
MEAN
590
S.D.
55.0
21 N
55
MEAN
619
S.D.
58.8
25 N
55
MEAN
644
S.D.
62.8
29 N
55
MEAN
663
S.D.
67.1
33 N
55
MEAN
678
S.D.
71.5
49 574
50.9
49 585
52.3
49 595
54.0
49 625
58.3
49 651
64.2
49 668
69.6
49 682
72.0
50 540*
51.9
50 547*
53.1
50 557*
53.4
50 582*
57.0
50 603*
62.1
50 618*
66.5
50 634*
70.2
59 519*
45.8
59 528*
45.6
59 536*
46.4
59 555*
51.4
59 572*
51.3
59 590*
54.7
59 599*
57.5
5 300 PPM
0
0
0
0
0
0
0
6 100 PPM
38 528*
47.5
38 536*
48.4
38 546*
50.2
38 567*
55.5
38 582*
60.7
38 602*
64.8
38 612*
64.5
7 300 PPM
0
0
0
0
0
0
0
Covance 6329-212 3M T-6316.1
PAGE: 3
000173
SEX: GROUP:
DOSE: WEEK UNITS:
1 0 PPM
37 N
55
MEAN
694
S.D.
77.1
41 N
55
MEAN
700
S.D.
71.4
45 N
54
MEAN
723
S.D.
76.2
49 N
54
MEAN
741
S.D.
78.3
53 N
54
MEAN
762
S.D.
81.9
Table 5 Summary of Body Weight Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
2 3 PPM
48 701
75.1
48 714
75.2
48 740
82.8
48 758
91.5
48 777
95.0
--- MALE----34 30 100 PPM PPM
50 646*
74.0
50 653*
77.1
50 678*
82.6
50 698*
87.5
50 716*
92.5
59 610*
57.6
59 619*
60.1
58 639*
64.9
58 654*
68.7
58 672*
68.4
5 300 PPM
0
0
0
0
0
6 100 PPM
38 623*
67.4
38 632*
68.2
37 650*
76.4
37 666*
80.4
36 688*
86.3
7 300 PPM
0
0
0
0
0
Covance 6329-212 3M T-6316.1
PAGE: 4
Table 5 Summary of Body Weight Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX:
GROUP:
1
2
3
4
5
67
DOSE:
0
3 30 100 300 100 300
WEEK UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
1N
70
MEAN
165
S.D.
13.2
60 163
13.3
60 165
12.9
70 164
12.1
70 164
12.6
39 164
12.5
40 163
12.0
2N
70
MEAN
188
S.D.
16.9
60 185
14.7
60 185
14.4
70 181*
13.5
70 172*
13.3
40 181
14.1
40 175*
11.7
3N
70
60
60
70
70
40
40
o
MEAN
211
205
205
200*
182*
202
186*
o
S.D.
20.8
18.5
16.5
15.5
15.1
15.8
12.2
4N
70
MEAN
229
S.D.
22.3
60 224
20.2
60 222
18.3
70 215*
17.1
70 191*
15.2
40 214*
15.9
40 196*
12.7
4* 5 N
65
55
55
65
65
40
40
MEAN
244
236
233*
225*
196*
223*
200*
S.D.
25.4
21.2
19.9
18.6
16.4
16.7
13.3
6N
65
MEAN
258
S.D.
28.3
55 246
22.7
55 245
21.2
65 235*
19.4
65 202*
16.6
40 234*
17.3
40 206*
14.4
7N
65
MEAN
267
S.D.
30.0
55 256
23.8
55 253
22.7
65 239*
19.6
65 205*
16.5
40 240*
17.4
40 210*
13.2
Covance 6329-212 3M T-6316.1
PAGE: 5
o o
r-
A
sT
01
WEEK
SEX: GROUP:
DOSE: UNITS:
8N MEAN S.D.
9N MEAN S.D.
10 N MEAN S.D.
11 N MEAN S.D.
12 N MEAN S.D.
13 N MEAN S.D.
14 N MEAN S.D.
1 0 PPM
65 274
30.4
60 283
32.1
60 290
33.6
60 295
35.1
60 302
36.6
60 306
36.3
60 308
36.3
Table 5 Summary of Body Weight Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
-- FEMALE--2 34 5 67 3 30 100 300 100 300 PPM PPM PPM PPM PPM PPM
55 261
24.9
55 271
25.6
55 277
27.3
55 281
28.7
55 284
28.6
55 289
27.5
55 292*
27.9
55 258*
23.6
55 268*
24.1
55 273*
25.1
55 275*
26.3
55 280*
26.7
55 284*
26.6
55 286*
27.7
65 246*
20.7
65 250*
20.7
65 254*
20.3
65 256*
21.8
65 258*
21.4
65 260*
21.7
65 262*
22.3
65 212*
17.1 0
0
0
0
0
0
40 243*
19.4
40 250*
18.9
40 253*
21.5
40 255*
19.9
40 259*
20.8
40 261*
20.2
40 264*
20.8
40 213*
14.9 0
0
0
0
0
0
Covance 6329-212 3M T-6316.1
PAGE: 6
SEX: GROUP:
DOSE: WEEK UNITS:
1 0 PPM
15 N
55
MEAN
310
S.D.
36.0
16 N
55
MEAN
316
S.D.
36.8
17 N
55
MEAN
320
S.D.
37.9
21 N
55
c.
MEAN
334
S.D.
41.9
25 N
55
MEAN
348
S.D.
47.6
29 N
55
MEAN
361
S.D.
51.9
33 N
55
MEAN
375
S.D.
55.1
Table 5 Summary o Body Weight Data {g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
2 3 PPM
50 295*
29.0
50 300*
31.0
50 306
30.2
50 318
33.7
50 334
38.7
50 346
42.7
50 359
48.3
--- FEMALE--34 30 100 PPM PPM
50 288*
27.9
50 293*
28.2
SO 297*
29.3
50 311*
32.8
50 324*
37.2
50 336*
40.2
50 349
44.1
60 263*
23.3
59 266*
23.0
59 270*
23.2
59 277*
24.8
58 286*
26.4
58 294*
28.2
58 301*
31.8
5 300 PPM
0
0
0
0
0
0
0
6 100 PPM
40 266*
21.9
40 269*
21.7
40 272*
22.2
40 279*
23.3
40 291*
24.5
40 299*
26.6
40 307*
30.0
7 300 PPM
0
0
0
0
0
0
0
Covance 6329-212 3M T-6316.1
PAGE: 7
Table 5 Summary of Body Weight Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX:
--- FEMALE---
GROUP:
1
2
3
4
5
6
7
DOSE:
0
3 30 100 300 100 300
WEEK UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
37 N
55
50
50
58
0 40
0
MEAN
384
366
355*
304*
313*
S.D.
58.2
48.9
46.4
34.0
32.2
41 N
55
50
50
58
0 40
0
MEAN
400
380
370
313*
323*
S.D.
64.7
52.3
48.2
36.5
34.8
45 N
55
50
50
58
0 40
0
MEAN
423
397
388
320*
332*
o
S.D.
72.3
59.3
54.0
40.5
38.0
c
49 N
54
50
50
58
0 40
0
C-i
MEAN
439
412
396*
329*
339*
K*
S.D.
76.0
63.2
55.3
43.1
40.6
"J 53 N 54 50 50 58
0 40
0
MEAN
454
425
404*
338*
350*
S.D.
82.1
67.9
62.5
48.7
44.3
Covance 6329-212 3M T-6316.1
PAGE: 8
Table 6 Summary of Body Weight Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
WEEK
SEX: GROUP:
DOSE: UNITS:
-------- MALE8 0
PPM
9 1 PPM
FEMALE' 89 01 PPM PPM
1N
70
MEAN
204
S.D.
18.8
2N
70
MEAN
260
S.D.
21.9
3N
70
MEAN
309
S.D.
25.3
4N
70
MEAN
351
S.D.
28.4
5N
65
MEAN
381
S.D.
33.1
6N
65
MEAN
409
S.D.
36.9
7N
65
MEAN
433
S.D.
40.2
70 202
19.4
70 260
22.1
70 309
25.4
70 350
28.4
65 383
33.4
65 413
36.4
65 438
40.4
70 152
10.8
70 179
13.9
70 202
16.1
70 224
19.6
65 240
19.9
65 253
22.3
65 263
24.5
70 152
11
70 179
13
70 203
15
70 223
17
65 236
17
65 251
20
65 260
21
Covance 6329-228 3M T-6316.1
PAGE: 1
Table 6 Summary of Body Weight Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
WEEK
SEX: -------- MALE-
GROUP:
8
DOSE:
0
UNITS:
PPM
9 1 PPM
------- FEMALE89 01
PPM PPM
8N
65
MEAN
451
S.D.
43.0
65 454
42.9
64 272
25.2
64 267
23.3
9N
65
MEAN
468
S.D.
45.9
65 472
45.3
64 282
27.6
65
274 23.9
10 N
65
MEAN
484
S.D.
49.7
65 490
47.4
64 287
28.4
65 281
25.7
o
11 N
65
65
64
65
MEAN
496
503
287
284
Cm
S.D.
54.3
48.9
29.0
26.3
V *
12 N
64
MEAN
510
65 517
64 296
65 288
w
S.D.
59.2
51.2
30.2
27.1
13 N
64
MEAN
523
S.D.
58.0
65 529
53.4
64 301
30.7
65 294
27.3
14 N
64
MEAN
531
S.D.
58.7
65 537
54.4
64 306
31.4
65 298
29.8
Covance 6329-228 3M T-6316.1
PAGE: 2
Table 6
Summary of Body Height Data (g)
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WEEK
SEX: -------- MALE-
GROUP:
8
9
DOSE:
0
1
UNITS:
PPM
PPM
------- FEMALE89 01
PPM PPM
15 N
59
MEAN
541
S.D.
60.2
16 N
59
MEAN
553
S.D.
60.8
17 N
59
MEAN
562
S.D.
61.8
21 N
59
MEAN
591
S.D.
68.4
C
u 25 N
59
MEAN
617
S.D.
73.3
03
C
29 N
59
MEAN
631
S.D.
76.8
33 N
59
MEAN
652
S.D.
81.0
60 545
56.4
60 555
59.9
60 564
62.7
60 593
70.0
60 616
74.5
60 630
77.5
60 655
84.4
59 307
34.1
59 314
35.0
59 319
35.8
59 332
41.3
59 345
46.7
59 354
48.3
58 371
53.9
60 302
30.8
60 307
32.3
60 309
33.9
60 325
39.3
60 340
46.4
60 348
51.5
60 366
60.0
Covance 6329-228 3M T-6316.1
PAGE: 3
%
Table 6
Summary of Body Height Data (g)
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WEEK
SEX: -------- MA]le--------
GROUP:
8
9
DOSE:
0
1
UNITS:
PPM
PPM
------- FEMJVLE-----
89 01 PPM PPM
37
41
o 6
c<
GO
45 49 53
N MEAN S.D.
N MEAN S.D.
N MEAN S.D.
N MEAN S.D.
N MEAN S.D.
59 681
85.7
59 697
90.0
59 719
94.9
59 732
98.6
58 751 102.7
60 674
89.2
60 693
93.2
58 709
99.8
58 726 105.2
58 738 110.7
58 389
60.1
58 402
63.8
58 416
68.8
57 431
74.4
56 445
78.1
60 380
60.3
60 392
64.5
60 407
68.9
60 423
72.3
58 436
74.2
Covance 6329-228 3M T-6316.1
PAGE: 4
SEX: GROUP:
DOSE: WEEK UNITS:
1 0
PPM
1-2 N MEAN S.D.
2-3 N MEAN S.D.
3-4 N MEAN S.D.
4-5 N MEAN S.D.
5-6 N MEAN S.D.
6-7 N MEAN S.D.
7-8 N MEAN S.D.
70 47
5.5
70 42
5.1
70 37
5.9
65 29
5.9
65 27
4.6
65 23
5.4
65 16
5.1
Table 7 Summary of Body Weight Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
2 3 PPM
60 47
5.0
60 43
6.1
60 38
5.8
55 28
7.5
55 29
5.5
55 22
5.3
55 13
7.4
3 30 PPM
60 43*
7.2
60 41
7.7
60 35
7.0
55 25*
5.7
55 27
5.2
55 19*
4.6
55 13
4.4
-- MALE---4
100 PPM
70 40*
6.3
70 38*
5.7
70 31*
5.6
65 26*
5.6
65 24*
6.2
65 19*
4.2
65 13
9.9
5 300 PPM
69 31*
6.4
70 30*
5.8
70 20*
5.4
64 16*
5.7
64 16*
5.9
65 10*
5.1
63 5*
14.1
6 100 PPM
40 42*
5.9
40 38*
6.6
40 30*
5.7
40 27
6.5
40 25
6.1
40 11* 16.5
39 20
6.0
7 300 PPM
40 30*
5.2
40 27*
5.8
40 21*
6.2
40 17*
6.3
40 15*
6.0
39 7*
11.3
39 10* 13.0
Covance G329-212 3M T-6316.1
PAGE: 1
Table 7 Summary of Body Height Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX: -
--- MALE----
GROUP:
1
2
3
4
5
67
DOSE:
0
3 30 100 300 100 300
WEEK UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
8-9 N MEAN S.D.
60 20
5.9
54 25*
5.0
55 19
8.0
65 16*
6.3
9-10
N MEAN S.D.
60 17
5.1
54 17
4.7
55 14
9.1
65 11*
6.2
10-11 N
60
54
55
65
o
MEAN
11
13
13
9
c-
S.D.
5.1
5.9
5.2
7.0
11-12 N
60
54
55
65
05
Ci
MEAN S.D.
11 6.1
13 5.2
12 4.7
11 7.3
12-13 N MEAN S.D.
60 10
9.4
54 9
12.1
55 9 4.1
65 7 7.5
13-14 N MEAN S.D.
60 10
7.6
54 8 7.6
55 8 5.7
64 6 8.4
14-15 N MEAN S.D.
55 7 5.7
49 8 5.5
50 6 7.8
59 5 5.5
0 0 0 0 0 0 0
39 16 14.2
39 9*
13.0
39 10
7.1
39 12
4.9
38 12
5.8
38 7 3.9
38 6 4.0
0 0 0 0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 2
SEX: GROUP:
DOSE: UNITS:
1 0
PPM
15-16 N MEAN S.D.
55 10
4.1
16-17 N MEAN S.D.
55 11
5.9
17-21 N MEAN S.D.
55 29
8.6
21-25 N
55
A
MEAN
26
c
S.D.
7.6
-. 25-29 N
55
MEAN
19
r#
S.D.
9.1
29-33 N MEAN S.D.
55 16 10.1
33-37 N MEAN S.D.
55 15 13.8
Table 7 Summary of Body Weight Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
--- MALE---234 567 3 30 100 300 100 300 PPM PPM PPM PPM PPM PPM
49 11
5.3
49 10
7.1
49 30
8.2
49 26 10.0
49 17 13.3
49 14 30.0
48 18 10.1
50 7* 4.5
50 10
5.5
50 25
8.6
50 21*
8.9
50 15 10.4
50 16 12.1
50 12
7.5
59 9 4.1
59 8* 5.3
59 19* 11.8
59 17*
9.8
59 18
8.2
59 9
11.4
59 10*
9.6
0 0 0 0 0 0 0
38 8 5.1
38 10
5.6
38 21* 10.8
38 16* 11.0
38 20
8.7
38 10
9.9
38 11
8.6
0 0 0 0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 3
H
Table 7 Summary of Body Height Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: -
--- MALE----
GROUP:
1
2
3
4
5
6
7
DOSE:
0
3 30 100 300 100 300
WEEK UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
37-41 N MEAN S.D.
55 6
20.8
48 12 15.7
50 7 8.2
59 9
9.3
41-45 N MEAN S.D.
54 25 10.5
48 27 12.3
50 24
9.5
58 19* 10.7
o 45-49 N 54 48 50 58
C
MEAN S.D.
19 10.7
18 21.1
20 10.5
15 9.3
Cw
49-53 N
54
48
50
58
MEAN
20
19
18
18
05
S.D.
8.1
18.3
9.1 11.3
07
1-53 N
54
48
50
58
MEAN
500
516
458*
414*
S.D.
73.2
84.8
82.1
59.2
0 38 9
25.6
0 37 18* 13.5
0 37 15 20.7
0 36 23 13.0
0 36 432* 80.6
0 0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 4
ooaisG
SEX: GROUP:
DOSE: WEEK UNITS:
1 0 PPM
1-2 N MEAN S.D.
2-3 N MEAN S.D.
3-4 N MEAN S.D.
4-5 N MEAN S.D.
5-6 N MEAN S.D.
6-7 N MEAN S.D.
7-8 N MEAN S.D.
70 23
6.8
70 22
7.7
70 18
6.1
65 14
6.6
65 14
6.2
65 10
6.5
65 7 5.4
Table 7
Summary of Body Weight Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYI PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
2 3 PPM
60 22
5.2
60 20
7.3
60 19
5.8
55 12
6.2
55 10*
5.8
55 11
5.4
55 4 6.1
3 30 PPM
60 20
5.7
60 20
6.4
60 17
6.9
55 12
6.0
55 12
5.4
55 8 5.5
55 5 5.6
4 100 PPM
70 17*
5.4
70 19*
5.5
70 15*
4.8
65 10*
4.3
65 9* 4.1
65 4* 5.4
65 7 4.7
5 300 PPM
70 9* 6.3
70 10*
4.6
70 9* 3.9
65 5* 4.8
65 7* 5.0
65 2* 3.9
65 8 4.6
6 100 PPM
39 17*
4.7
40 20
4.3
40 13*
4.7
40 9* 4.2
40 10*
3.8
40 6* 4.2
40 3* 5.7
7 300 PPM
40 12*
4.9
40 11*
4.8
40 9* 3.4
40 4* 4.3
40 6* 3.5
40 4* 4.5
40 3* 3.8
Covance 6329-212 3M T-6316.1
PAGE: 5
WEEK
SEX: GROUP:
DOSE: UNITS:
1 0 PPM
8-9 N MEAN S.D.
60 9 5.8
9-10
N MEAN S.D.
60 8 S.6
10-11 N
60
MEAN
5
o
S.D.
6.4
11-12 N
60
MEAN
7
S.D.
6.7
QS 12-13 N
60
MEAN
4
S.D.
6.2
13-14 N MEAN S.D.
60 2 5.8
14-15 N MEAN S.D.
55 3 5.0
Table 7 Summary of Body Weight Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
-- FEMALE---
234 567
3 30
100 300 100 300
PPM PPM PPM PPM PPM PPM
55 10
5.0
55 5 5.9
55 5 6.5
55 3 5.0
55 5 4.8
55 3 5.2
50 3 6.0
55 9 6.0
55 5* 4.9
55 2 5.9
55 5 6.4
55 4 5.1
55 2 4.8
50 2 4.6
65 4* 4.2
65 4* 5.0
65 2 4.9
65 2* 3.8
65 2* 4.6
65 3 4.3
60 1 4.2
0 0 0 0 0 0 0
40 7 5.2
40 4* 5.3
40 2 4.5
40 3 4.9
40 2 4.0
40 3 3.9
40 2 3.8
0 0 0 0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 6
SEX: GROUP:
DOSE: WEEK UNITS:
1 0 PPM
15-16 N MEAN S.D.
55 6 5.1
16-17 N MEAN S.D.
55 5 5.4
17-21 N
55
MEAN
13
S.D.
7.9
o
21-25 N
55
o
MEAN
14
S.D.
10.9
25-29 N
55
QO
MEAN
13
QO
S.D.
10.9
29-33 N MEAN S.D.
55 13 10.1
33-37 N MEAN S.D.
55 10 12.4
Table 7 Summary of Body Weight Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
-- FEMALE--2 3 4 5 67 3 30 100 300 100 300 PPM PPM PPM PPM PPM PPM
50 5 5.4
50 6 6.0
50 12
8.1
50 16 10.3
50 12
8.8
50 13 11.9
50 7 8.9
50 5 5.1
50 5 4.9
50 14
8.8
50 13
9.0
50 12
7.7
50 13
8.7
50 6 9.7
59 3* 4.1
59 4 4.5
59 7* 4.8
58 9* 6.0
58 8* 6.3
58 7* 7.8
58 3* 9.4
0 0 0 0 0 0 0
40 3* 3.6
40 4 4.3
40 7* 5.4
40 12
5.7
40 8* 6.2
40 8 6.2
40 6 4.6
0 0 0 0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 7
Table 7 Summary of Body Height Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: -
--- FEMALE---
GROUP:
1
2
3
4
5
6
7
DOSE:
0
3 30 100 300 100 300
WEEK UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
37-41 N MEAN S.D.
55 16 12.9
50 14 10.4
50 14
8.6
58 9* 9.8
0
40 10*
5.4
0
41-45 N MEAN S.D.
55 23 12.3
50 17* 12.4
50 18 10.9
58 7* 8.3
0
40 10*
6.0
0
45-49 N MEAN S.D.
54 17
9.2
50 15 10.2
50
9* 16.0
58 8* 8.3
0
40 7* 7.3
0
49-53 N
54
50
50
58
0 40
0
MEAN
15
13
7
9
11
S.D.
11.3
10.2
27.5
8.7
8.0
o
o
1-53 N MEAN
54 289
50 260
50 240*
58 172*
0 39 186*
0
S.D.
77.3
62.4
59.2
47.0
42.4
Covance 6329-212 3M T-6316.1
PAGE: 8
Table 8 Summary of Body Weight Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: -------- MALE-
GROUP:
8
9
DOSE:
0
1
WEEK UNITS:
PPM
PPM
------- FEMALE-
89 01 PPM 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.
70 56
6.2
70 49
7.2
70 42
6.2
65 30
6.3
65 28
5.9
65 24
5.7
65 17
5.3
70 58
5.8
70 49
7.3
70 41
7.2
65 33
7.8
65 30
6.0
65 25
6.3
65 16
6.2
70 27
6.7
70 22
7.7
70 22
7.9
65 15
6.9
65 14
6.8
65 10
7.1
64 10
6.5
70 27
6.1
70 24
8.0
70 20
7.5
65 15
7.0
65 15
6.2
65 9 5.8
64 7 7.2
Covance 6329-228 3M T-6316.1
PAGE: 1
Table 8 Summary of Body Weight Change Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT*
WEEK
SEX: -------- MALE-
GROUP:
8
DOSE:
0
UNITS:
PPM
----- ------- FEMALE----
989
10
1
PPM PPM 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.
14-15 N MEAN S.D.
65 18
5.5
65 16 10.7
65 12 10.7
64 13
7.3
64 12
7.2
64 9 7.7
59 10
8.1
65 18
4.4
65 17
5.2
65 13
5.0
65 14
5.4
65 12
5.7
65 8 4.5
60 10
5.2
63 9 5.6
64 5 6.0
64 0 7.0
64 9 6.1
64 6 6.6
64 5 6.0
59 0 6.5
64 7 5.2
65 7 6.0
65 3* 6.5
65 4* 6.2
65 6 6.1
65 5 6.5
60 2 6.7
Covance 6329-228 3M T-6316.1
PAGE: 2
26TCOO
SEX: GROUP:
DOSE: WEEK UNITS:
15- N16 MEAN S.D.
16- N17 MEAN S.D.
17-21 N MEAN S.D.
21-25 N MEAN S.D.
25-29 N MEAN S.D.
29-33 N MEAN S.D.
33-37 N MEAN S.D.
Table 8
Summary of Body Height Change Data (g)
`DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
-MALE-
80 91
PPM PPM
-FEMALE-
8
0
91
PPM PPM
59 12
5.8
59 9 5.2
59 29
9.6
59 26
8.7
59 14
9.4
59 21 11.3
59 29 12.4
60 11
6.2
60 8 5.5
60 29 11.0
60 23
8.7
60 14
8.6
60 25 10.6
60 19* 10.2
59 7 5.7
59 4 7.4
59 13 12.0
59 13 10.5
59 9
14.9
58 18 10.5
58 18 10.1
60 5* 5.9
60 2 6.2
60 16 11.2
60 15 12.5
60 8
10.1
60 18 27.9
60 14 27.0
Covance 6329-228 3M T-6316.1
PAGE: 3
003193
Table 8
Summary of Body Height Change Data (g)
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WEEK
SEX: -------- MALE-
GROUP:
8
DOSE:
0
UNITS:
PPM
9 1 PPM
------- FEMALE89 01
PPM PPM
37-41 N MEAN S.D.
41-45 N MEAN
S.D.
45-49 N MEAN S.D.
49-53 N MEAN S.D.
1-53
N MEAN S.D.
59 16
9.9
59 23 12.5
59 13 10.9
58 17 10.5
58 548
93.5
60 19*
9.2
58 18* 10.3
58 17* 10.4
58 12* 11.1
58 536 102.5
58 13
8.5
58 13 11.0
57 14 11.6
56 12 15.7
56 292
72.1
60 12 10.
60 15 10.
60 16 15.
58 13
9.
58 284
70.
Covance 6329-228 3M T-6316.1
PAGE: 4
003.194
WEEK
SEX: GROUP:
DOSE: UNITS:
l 0 PPM
1N
68
MEAN
175
S.D.
15.2
2N
69
MEAN
180
S.D.
13.3
3N
65
MEAN
186
S.D.
13.5
4N
65
MEAN
191
S.D.
15.2
5N
64
MEAN
190
S.D.
15.6
6N
62
MEAN
191
S.D.
16.9
7N
58
MEAN
192
S.D.
17.6
Table 9 Summary of Food Consumption Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
--- MALE----
2 34 5 67 3 30 100 300 100 300 PPM PPM PPM PPM PPM PPM
59 171
15.2
59 177
15.2
58 181
16.2
54 185
15.7
52 188
15.5
54 188
15.4
53 190
17.0
58 172
16.6
57 174
17.5
58 176*
17.6
50 177*
14.2
54 180*
16.8
52 179*
15.9
51 180*
14.4
69 170
14.9
68 168*
14.8
67 169*
14.0
63 170*
13.9
65 172*
14.3
64 170*
13.2
64 168*
18.9
68 162*
15.9
68 154*
14.3
67 150*
14.4
63 147*
14.6
60 147*
16.2
62 146*
15.8
59 145*
15.9
39 170
11.3
39 170*
14.9
40 171*
14.1
40 173*
16.6
39 173*
16.0
40 170*
21.1
39 170*
19.5
38 160*
13.3
39 151*
13.2
38 147*
13.0
40 146*
17.5
39 145*
13.9
39 146*
15.9
38 140*
24.0
Covance 6329-212 3M T-6316.1
PAGE: 1
003195
WEEK
SEX: GROUP:
DOSE: UNITS:
8N MEAN S.D.
9N MEAN S.D.
10 N MEAN S.D.
11 N MEAN S.D.
12 N MEAN S.D.
13 N MEAN S.D.
14 H MEAN S.D.
i 0 PPM
55 191
18.4
56 187
16.5
60 186
15.4
58 184
16.8
56 181
17.2
58 188
20.7
52 185
17.9
Table 9
Summary of Food Consumption Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
2 34 5 67 3 30 100 300 100 300 PPM PPM PPM PPM PPM PPM
52 53 65
0 38
0
189
179*
170*
171*
15.2
15.1
14.6
25.4
52 52 64
0 39
0
188
178*
166*
167*
16.4
17.7
13.5
27.8
54 188
18.2
55 178
16.8
65 164*
16.9
0 39 166* 26.1
0
54 52 64
0 39
0
187 177 164*
169*
16.3
15.5
17.9
25.2
53 183
15.8
55 174
16.2
64 162*
19.9
0 38 171* 15.2
0
52 186
15.6
54 178*
16.0
63 165*
18.4
0 37 174* 14.3
0
48 48 59
0 38
0
184
169*
168*
173*
17.6
21.5
15.7
14.6
Covance S329-212 3M T-6316.1
PAGE: 2
%
Table 9 Summary of F o o d Consumption Data Ig)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX:
GROUP:
1
2
3
4
5
67
DOSE:
0
3 30 100 300 100 300
WEEK UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
15 N
54
49
46
57
0 38
0
MEAN
191
189
176*
170*
175*
S.D.
19.1
17.9
16.9
11.5
15.5
16 N
51
49
49
59
0 38
0
MEAN
187
188
178*
171*
176*
S.D.
13.1
18.4
17.4
13.1
15.3
20 N
54
49
48
57
0 38
0
MEAN
192
194
184
177*
181*
S.D.
16.7
17.8
15.9
19.2
17.0
o e
24 N
55
49
50
58
0 38
0
MEAN
190
189
183
177*
180*
S.D.
18.2
17.3
16.5
14.2
17.7
Co
H-
28 N
54
MEAN
189
49 176*
49 176*
59 176*
0 37 178*
0
W
S.D.
17.5
24.2
18.1
14.7
16.2
cn 32 N 55 48 50 57
0 35
0
MEAN
193
190
187
181*
181*
S.D.
17.5
28.1
15.8
14.7
18.1
36 N
55
47
49
59
0 38
0
MEAN
195
197
188
185*
187
S.D.
20.7
19.0
16.5
17.0
18.6
Covance 6329-212 3M T-6316.1
PAGE: 3
WEEK
SEX: GROUP:
DOSE: UNITS:
1 0 PPM
40
44
48
52
<*>
6
La3
b
N MEAN S.D.
N MEAN S.D.
N MEAN S.D.
N MEAN S.D.
54 204
26.8
54 195
20.1
54 194
17.6
54 192
17.4
Table 9 Summary of Food Consumption Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
--- MALE----
2 34 567 3 30 100 300 100 300 PPM PPM PPM PPM PPM PPM
46 209
16.4
48 196
17.3
48 196
18.9
48 194
24.0
50 203
19.7
50 188
18.1
50 186
18.0
49 186
17.4
59 195
17.8
57 183*
18.3
58 182*
16.5
58 180*
17.0
0 37 192* 30.6
0 37 184* 18.9
0 37 185 18.0
0 36 183 18.4
.0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 4
86T00
Table 9 Summary of Food Consumption Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX: ------------------------------------- FEMALE
GROUP:
1
2
3
4
5
67
DOSE:
0
3 30 100 300 100 300
WEEK UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
1N
63
MEAN
130
S.D.
23.8
2N
61
MEAN
132
S.D.
20.7
3N
57
MEAN
136
S.D.
15.5
4N
55
MEAN
141
S.D.
15.8
5N
55
MEAN
142
S.D.
18.7
6N
55
MEAN
138
S.D.
15.8
7N
53
MEAN
140
S.D.
17.6
56 124
15.2
55 130
15.9
53 135
22.4
42 138
23.0
46 134
15.5
42 138
18.7
44 133
14.9
54 125
16.0
50 127
16.6
49 129
16.7
46 134
15.2
50 136
20.3
45 135
19.6
50 130*
16.9
59 122*
13.2
60 125
16.9
57 124*
14.9
57 127*
15.0
56 122*
12.0
59 121*
11.5
61 117*
10.8
57 112*
14.9
63 105*
15.9
62 99* 14.3
55 96* 12.5
59 97* 16.0
58 96* 12.6
60 95* 11.2
36 121*
16.0
39 122*
17.8
40 122*
14.8
35 121*
13.2
40 122*
13.8
39 117*
13.4
40 116*
16.2
33 115*
14.3
35 111*
16.5
36 101*
12.3
36 100*
13.1
35 98* 10.3
36 98* 14.6
38 98* 16.0
Covance 6329-212 3M T-6316.1
PAGE: 5
Table 9 Summary of Food Consumption Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX: -
--- FEMALE---
GROUP:
1
2
3
4
5
67
DOSE:
0
3 30 100 300 100 300
UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
8N
52
45
44
57
0 33 .0
MEAN
135
140
136
119*
120*
S.D.
16.3
23.7
25.0
12.0
16.0
9N
54
47
48
60
0 39
0
MEAN
131
128
127
118*
114*
S.D.
14.4
19.2
17.3
23.4
13.7
10 N
51
44
47
60
0 37
0
MEAN
135
130
127
115*
114*
S.D.
21.5
19.6
18.4
15.6
10.4
11 N
52
44
49
62
0 37
0
o
Cj
MEAN S.D.
131 18.9
128 22.2
131 25.6
115* 20.1
116* 13.6
t o 12 N
54
43
51
62
0 38
0
L -L
MEAN
127
121
128
113*
rr *
S.D.
13.6
13.7
16.5
14.4
114* 16.9
tWwA
13 N
56
MEAN
124
47 125
54 125
64 113*
0 39 111*
0
S.D.
15.9
21.8
20.3
20.9
14.0
14 N
52
45
45
57
0 38
0
MEAN
127
126
124
113*
112*
S.D.
17.8
22.9
15.6
19.5
11.7
Covance 6329-212 3M T-6316.1
PAGE: 6
Table 9 Summary of Food Consumption Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX:
GROUP:
1
2
3
4
5
6
7
DOSE:
0
3 30 100 300 100 300
WEEK UNITS:
PPM
PPM
PPM
PPM
PPM
PPM
PPM
15 N
48
38
42
55
0 39
0
MEAN
127
125
128
114*
114*
S.D.
13.4
21.6
16.1
10.8
12.0
16 N
49
42
44
56
0 38
0
MEAN
127
127
127
113*
114*
S.D.
13.6
16.1
19.4
10.5
13.4
20 N
48
41
47
53
0 38
0
MEAN
134
132
134
120*
121*
S.D.
15.4
19.6
21.0
12.0
13.1
o
24 N
53
47
47
54
0 38
0
0,
MEAN
134
140
135
123*
122*
C>*
S.D.
17.1
24.0
20.1
18.1
12.4
0
28 N
51
46
45
55
0 39
0
ow
MEAN
137
136
133
122*
S.D.
19.3
19.0
14.6
15.1
125* 13.5
32 N
54
48
48
55
0 36
0
MEAN
140
143
141
130*
129*
S.D.
20.7
20.6
21.4
18.0
12.0
36 N
54
47
49
54
0 37
0
MEAN
146
149
142
135*
134*
S.D.
23.1
25.0
19.5
27.0
12.8
Covance 6329-212 3M T-6316.1
PAGE: 7
oo
Cj
o
GROUP: DOSE:
WEEK UNITS:
40 N MEAN S.D.
44 N MEAN S.D.
48 N MEAN S.D.
52 N MEAN S.D.
1 0 PPM
51 158
21.8
54 154
24.0
53 147
22.6
54 148
24.8
Table 9
Summary of Food Consumption Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
234567 3 30 100 300 100 300 PPM PPM PPM PPM PPM PPM
48 49 56
0 38
0
162 158 148
149
21.1
22.4
24.9
15.2
48 149
20.3
50 150
19.6
56 133*
20.4
0 40 137* 20.3
0
49 50 56
0 39
0
145 142 137*
135*
19.3
19.9
26.5
14.8
46 144
15.7
48 137*
25.2
55 133*
20.8
0 39 130* 15.6
0
Covance 6329-212 3M T-6316.1
PAGE: 8
Tabla 10 Summary of Food Consumption Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
S E X : -------- MALE
GROUP:
8
DOSE:
0
WEEK UNITS:
PPM
------ ------- FEMALE-----
91 0 8
91
PPM PPM
PPM
1N
70
MEAN
167
S.D.
12.9
2N
69
MEAN
174
S.D.
15.6
3N
69
MEAN
180
S.D.
15.6
4N
63
MEAN
182
S.D.
16.2
5N
63
MEAN
185
S.D.
17.7
6N
62
MEAN
186
S.D.
19.2
7N
65
MEAN
189
S.D.
19.1
69 166
13.9
69 175
17.4
67 180
21.6
64 183
17.7
60 186
19.2
62 187
19.5
64 189
20.1
46 128
13.5
51 129
13.9
63 137
19.3
50 138
13.6
55 136
14.5
55 141
18.8
61 141
17.8
57 126
12.6
55 129
13.5
66 138
20.1
58 138
18.6
53 137
12.3
52 139
13.4
57 137
15.2
Covance 6329-228 3M T-6316.1
PAGE: 1
Table 10 Summary of Food Consumption Data (g)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
WEEK
SEX: -------- MALE-
GROUP:
8
DOSE:
0
UNITS:
PPM
9 1 PPM
FEMALE 89 01 PPM PPM
8N
63
MEAN
188
S.D.
19.6
9N
63
MEAN
188
S.D.
18.9
10 N
63
MEAN
186
S.D.
28.8
11 N
62
MEAN
187
S.D.
19.9
12 N
63
MEAN
192
S.D.
19.4
13 N
64
MEAN
194
S.D.
19.7
14 N
47
MEAN
196
S.D.
19.0
61 188
20.8
64 191
21.0
63 190
17.6
61 187
16.9
64 194
17.6
64 195
18.4
50 189
16.2
54 139
17.4
57 137
18.4
51 138
15.1
52 132
14.9
53 131
16.7
60 13 6
17.6
42 131
13.7
48 137
17
58 135
16
51 136
20
51 127
13
55 134
13
61 140
19
38 138
20
Covance 6329-228 3M T-6316.1
PAGE: 2
corroo
Table 10
Summary of Food Consumption Data (g)
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WEEK
SEX: -------- MALE--------
GROUP:
8
9
DOSE:
0
1
UNITS:
PPM
PPM
------- FEMALE 8 0
PPM
9 1 PPM
15 N
59
MEAN
190
S.D.
19.5
16 N
55
MEAN
192
S.D.
20.3
20 N
58
MEAN
187
S.D.
19.9
24 N
58
MEAN
191
S.D.
21.3
28 N
55
MEAN
194
S.D.
20.0
32 N
59
MEAN
192
S.D.
21.3
36 N
58
MEAN
190
S.D.
18.5
58 193
18.4
60 193
20.6
57 187
19.6
60 190
17.9
56 194
18.0
60 197
20.7
56 192
19.4
56 132
14.8
47 131
18.2
56 136
19.3
57 144
28.2
53 150
21.4
57 149
21.9
57 144
19.1
54 138
22.9
48 134
14.7
52 141
24.4
55 141
20.5
57 151
23.3
59 151
23.2
54 148
15.9
Covance 6329-228 3M T-6316.1
PAGE: 3
Table 10
summary of Food Consumption Data (g)
*DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WEEK
SEX: GROUP:
DOSE: UNITS:
-------- M W JB--------
89 01 PPM PPM
------- FEMJU ----89 01
PPM PPM
40 N
59
MEAN
189
S.D.
19.9
44 N
58
MEAN
185
S.D.
21.8
o
rLoi-
48
N MEAN
S.D.
59 182
21.8
C 52 N
58
MEAN
189
C/T
S.D.
21.7
60 189
19.6
58 186
21.4
58 187
21.4
57 183
20.7
57 143
17.7
58 143
17.3
56 144
19.9
55 146
27.1
57 144
20.1
58 145
18.6
59 146
27.0
51 148
27.4
Covance 6329-228 3M T-6316.1
PAGE: 4
Table 11 Summary of Test Material Consumption Data (mg/kg/day)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP:
DOSE: UNITS:
2 3 PPM
3 30 PPM
-MALE--------45 100 300
PPM PPM
6 100
PPM
7 300 PPM
iN MEAN S.D.
59 0.259 0.016
58 2.618 0.170
69 8.724 0.561
68 25.408
1.919
39 8.873 0.572
38 25.193
1.230
2N MEAN S.D.
59 0.231 0.012
57 2.323 0.166
68 7.544 0.467
68 21.735
1.585
39 7.707 0.503
39 21.759
1.462
3N
58
58
67
67
40
38
MEAN
0.210
2.088
6.864
19.533
6.988
19.559
S.D.
0.011
0.123
0.306
1.195
0.339
0.920
c--. 4 N
54
50
63
62
40
40
MEAN
0.197
1.953
6.393
18.112
6.533
18.294
S.D.
0.011
0.108
0.280
0.938
0.338
1.663
& 5 N 52 54 65 59 39 39
MEAN
0.187
1.852
6.067
17.253
6.135
17.415
S.D.
0.009
0.115
0.300
0.987
0.341
0.733
6N MEAN S.D.
54 0.177 0.008
52 1.737 0.102
64 5.698 0.236
62 16.576
0.999
40 5.764 0.435
39 16.815
1.021
7N MEAN S.D.
53 0.172 0.011
51 1.694 0.091
64 5.418 0.409
59 16.058
0.918
39 5.536 0.320
38 15.803
2.209
Covance 6329-212 3M T-6316.1
PAGE: 1
s
c*)
C-. fg
WEEK
SEX GROUP
DOSE UNITS:
PPM
8. N MEAN S.D.
9N MEAN S.D.
10 N MEAN S.D.
11 N MEAN S.D.
12 N MEAN S.D.
13 N MEAN S.D.
14 N MEAN S.D.
52 0.164 0.008
52 0.156 0.010
54 0.152 0.011
54 0.147 0.009
53 0.141 0.009
52 0.143 0.010
48 0.139 0.010
Table 11 Summary of Test Material Consumption Data (mg/kg/day)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
3 30 PPM
-MALE45 100 300 PPM PPM
.6 100 PPM
7 300 PPM
53 1.629 0.099
52 1.564 0.104
55 1.517 0.105
52 1.472 0.086
55 1.421 0.101
54 1.426 0.097
48 1.357 0.153
65 5.329 0.251
64 5.031 0.280
65 4.871 0.355
64 4.772 0.324
64 4.616 0.364
63 4.616 0.346
59 4.655 0.348
0 0 0 0 0 0 0
38 5.325 0.496
39 5.043 0.592
39 4.940 0.477
39 4.926 0.349
38 4.800 0.279
37 4.808 0.263
38 4.709 0.241
0 0 0 0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 2
Table 11 Summary of Test Material Consumption Data (mg/kg/clay)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
SEX: GROUP:
DOSE: UNITS:
2 3 PPM
3 30 PPM
-MALE--------45 100 300 PPM PPM
6 100 PPM
7 300 PPM
15 N MEAN S.D.
16 N MEAN S.D.
20 N MEAN S.D.
24 N MEAN S.D.
28 N MEAN S.D.
32 N MEAN S.D.
36 N MEAN S.D.
49 0.140 0.009
49 0.137 0.009
49 0.134 0.008
49 0.126 0.008
49 0.114 0.018
48 0.120 0.016
47 0.120 0.008
46 1.397 0.115
49 1.384 0.105
48 1.367 0.087
50 1.309 0.090
49 1.231 0.116
50 1.276 0.093
49 1.261 0.102
57 4.641 0.222
59 4.608 0.248
57 4.545 0.340
58 4.447 0.291
59 4.300 0.275
57 4.298 0.303
59 4.355 0.428
0 0 0 0 0 0 0
38 4.694 0.241
38 4.661 0.227
38 4.586 0.264
38 4.438 0.245
37 4.249 0.246
35 4.246 0.250
38 4.305 0.255
0 0 0 0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 3
Table 11 Summary of Test Material Consumption Data (mg/kg/day)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
SEX: GROUP:
DOSE: WEEK UNITS:
2 3 PPM
3 30 PPM
-------- MALE45
100 300 PPM PPM
6 100 PPM
7 300 PPM
40 N MEAN S.D.
46 0.126 0.009
50 1.340 0.110
59 4.532 0.407
44 N MEAN S.D.
48 0.115 0.007
50 1.203 0.094
57 4.103 0.346
C 48 N
48
50
58
MEAN
0.111
1.155
3.994
S.D.
0.010
0.095
0.321
fw
o 52 N
48
49
58
C2
MEAN
0.108
1.126
3.847
S.D.
0.012
0.084
0.332
0 0 0 0
37 4.358 0.631
37 4.069 0.229
37 3.996 0.268
36 3.841 0.222
0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 4
H
Table 11
Summary of Test Material Consumption Data (mg/kg/day)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DRAFT*
GROUP: DOSE:
WEEK UNITS:
2 3 PPM
3 30 PPM
4 100 PPM
5 300 PPM
6 100 PPM
7 300 PPM
1N MEAN S.D.
56
0.307 0.037
54 3.070 0.386
59 10.166
1.080
57 28.712
3.562
36 10.135
1.157
33 29.270
3.365
2N MEAN S.D.
55 0.286 0.033
50 2.791 0.319
60 9.372 1.179
63 25.653
4.087
39 9.093 1.058
35 26.381
4.036
3N
53
49
57
62
40
36
o
MEAN
0.271
2.595
8.509
22.650
8.376
22.505
o
S.D.
0.051
0.317
0.873
3.249
0.800
2.640
4N
42
46
57
55
35
36
MEAN
0.256
2.540
8.314
21.385
7.946
21.593
S.D.
0.038
0.238
0.912
2.132
0.574
2.667
o 5N
46
50
56
59
40
35
MEAN
0.239
2.442
7.581
20.872
7.644
20.702
S.D.
0.023
0.271
0.610
2.782
0.593
1.771
6N MEAN S.D.
42 0.234 0.027
45 2.312 0.271
59 7.316 0.624
58 20.229
2.277
39 7.115 0.638
36 20.300
3.150
7N MEAN S.D.
44 0.219 0.018
50 2.183 0.225
61 6.942 0.555
60 19.568
1.815
40 6.839 0.727
38 20.004
3.757
Covance 6329-212 3M T-6316.1
PAGE: 5
TTJ-POO
Table 11 Summary of Test Material Consumption Data (mg/kg/day)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT*
SEX: ------------------------------- FEMALE-----------------------------
GROUP:
2
3
4
5
6
7
DOSE:
3
30
100 300 100 300
WEEK UNITS: PPM PPM PPM PPM PPM PPM
8N MEAN S.D.
9N MEAN S.D.
10 N MEAN S.D.
11 N MEAN S.D.
12 N MEAN S.D.
13 N MEAN S.D.
14 N MEAN S.D.
45 0.225 0.040
47 0.201 0.029
44 0.199 0.027
44 0.193 0.035
43 0.181 0.023
47 0.184 0.031
45 0.182 0.031
44 2.237 0.390
48 2.007 0.203
47 1.993 0.228
49 2.016 0.342
51 1.952 0.246
54 1.879 0.275
45 1.846 0.155
57 6.907 0.675
60 6.656 1.398
60 6.413 0.760
62 6.456 1.352
62 6.213 0.720
64 6.200 1.400
57 6.174 1.263
0 0 0 0 0 0 0
33 7.017 0.722
39 6.458 0.446
37 6.488 0.543
37 6.508 0.898
38 6.312 0.861
39 6.045 0.705
38 6.058 0.429
0 0 0 0 0 0 0
Covance 6329-212 3M T-6316.1
PAGE: 6
Table 11
Summary of Test Material Consumption Data (mg/kg/day)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
GROUP: DOSE:
WEEK UNITS:
2 3 PPM
3 30 PPM
4 100 PPM
5 300 PPM
15 N MEAN S.D.
38 0.179 0.028
42 1.873 0.178
55 6.130 0.515
0
16 N MEAN S.D.
42 0.177 0.018
44 1.841 0.217
56 6.010 0.423
0
O
20 N MEAN
41 0.178
47 1.844
53 6.163
O*
S.D.
0.027
0.184
0.484
24 N
47
47
54
fw
MEAN
0.183
1.782
6.214
k*
S.D.
0.036
0.192
1.082
10 28 N
46
45
55
MEAN
0.170
1.696
5.916
S.D.
0.025
0.120
0.575
0 0 0
32 N MEAN S.D.
48 0.172 0.028
48 1.739 0.207
55 6.162 0.808
0
36 N MEAN S.D.
47 0.175 0.031
49 1.732 0.205
54 6.349 1.458
0
6 100 PPM
39 6.128 0.383
38 6.018 0.475
38 6.206 0.436
38 6.030 0.348
39 5.977 0.413
36 6.080 0.475
37 6.125 0.448
7 300 PPM
0
0
0
0
0
0
0
Covance 6329-212 3M T-6316.1
PAGE: 7
Table 11
Summary of Test Material Consumption Data (mg/kg/day)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS `DRAFT*
GROUP: DOSE:
WEEK UNITS:
2 3 PPM
3 30 PPM
4 100 PPM
5 300 PPM
40 N MEAN S.D.
44 N MEAN S.D.
e 48 N o MEAN
S.D.
f w 52 N MEAN S.D.
CO
48 0.184 0.027
48 0.163 0.020
49 0.153 0.018
46 0.147 0.018
49 1.853 0.258
50 1.677 0.195
50 1.550 0.215
48 1.454 0.250
56 6.788 1.158
56 5.946 0.888
56 5.976 1.169
55 5.686 0.899
0 0 0 0
6 100 PPM
38 6.631 0.448
40 5.912 0.783
39 5.715 0.425
39 5.355 0.552
7 300 PPM
0
0
0
0
Covance 6329-212 3M T-6316.1
PAGE: 8
Table 12
Summary of Test Material Consumption Data (mg/kg/day)
`DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WEEK
SEX: GROUP:
DOSE: UNITS:
--MALE----- --FEMALE99
11
PPM PPM
1N
69
57
MEAN
0.103
0.108
S.D.
0.007
0.010
2N MEAN S.D.
69 0.088 0.007
55 0.096 0.009
3N
67
66
o
MEAN
0.078
0.092
o
S.D.
0.008
0.013
C,5 4 N
64
58
?v
MEAN
0.071
0.086
H*
S.D.
0.004
0.011
H-* 5 N
60
53
MEAN
0.066
0.080
S.D.
0.004
0.005
6N MEAN
S.D.
62 0.063 0.003
52 0.077 0.007
7N
64
56
MEAN
0.061
0.075
S.D.
0.005
0.008
Covance 6329-228 3M T-6316.1
PAGE: 1
Table 12
Summary of Test Material Consumption Data (mg/kg/day)
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WEEK
SEX: ---MALE---
GROUP:
9
DOSE:
1
UNITS: PPM
--FEMALE9
1 PPM
8N MEAN S.D.
61 0.058 0.005
47 0.072 0.010
9N MEAN S.D.
64 0.057 0.004
58 0.070 0.009
o 10 N
63
51
o
MEAN
0.055
0.069
S.D.
0.004
0.010
Cui
11 N
61
51
H1
MEAN S.D.
0.053 0.003
0.063 0.007
C/l
12 N
64
55
MEAN
0.053
0.066
S.D.
0.004
0.006
13 N MEAN S.D.
64 0.052 0.003
61 0.067 0.009
14 N MEAN S.D.
50 0.051 0.003
38 0.065 0.009
Covance 6329-228 3M T-6316.1
PAGE: 2
Table 12
Summary of Test Material Consumption Data (mg/kg/day)
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
SEX: --- MALE--- -- FEMALE-
GROUP:
9
9
DOSE:
1
1
WEEK UNITS : PPM
PPM
15 N MEAN S.D.
58 0.050 0.003
54 0.064 0.012
16 N MEAN S.D.
60 0.049 0.003
48 0.062 0.006
20 N
57
52
e
MEAN
0.045
0.062
o
S.D.
0.003
0.012
(Li 24 N
60
55
MEAN
0.045
0.060
S.D.
0.004
0.009
O 28 N
56
57
MEAN
0.044
0.062
S.D.
0.004
0.008
32 N MEAN S.D.
60 0.043 0.003
59 0.060 0.010
36 N MEAN S.D.
56 0.041 0.003
54 0.056 0.007
Covance 6329-228 3M T-6316.1
PAGE: 3
Table 12
Summary of Test Material Consumption Data (mg/kg/day)
DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%)
N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WEEK
SEX: --- MALE---
GROUP:
9
DOSE:
1
UNITS: PPM
-- FEMALE9 1
PPM
40 N MEAN S.D.
44 N MEAN S.D.
o 48 N c MEAN
S.D.
tLsX)
52 N MEAN
r " S.D.
60 0.039 0.003
58 0.038 0.003
58 0.037 0.003
57 0.036 0.003
57 0.053 0.007
58 0.052 0.006
59 0.050 0.009
51 0.049 0.008
Covance 6329-228 3M T-6316.1
PAGE: 4
Table 13
Summary of Clinical Hematology Data
Males
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV MCH MCHC PLT
X10(/fih G/DL
FL PG % X10V/iL
Covance 6329-212 3M T-6316.1
0 MEAN S.D. N
8.27 .267 5
15.3 .44 5
44.7 1.43 5
54.1 1.10 5
18.5
.40 5
34.1 .61 5
1269
111 5
300
MEAN
6.61 * 12.7 * 37.1 * 56.3
19.2
34.1
1092
<>
S.D.
.609
.68 2.14
2.65
.82
.72 112
N 5555555
t:.
03
DOSE ppm
WBC XlOV/iL
Table 13
Summary of Clinical Hematology Data
Males
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
X10*/fiL X10*//iL
MONO
EOSIN
BASO
N-SEG%
X10*/lj XlO'/^iL XlOV/iL
LYMPH%
MONO%
EOSIN%
Covane 329-212 3M T-6316.1
BASO%
0
MEAN
8.5
1.2
6.9
.4
.1
S.D.
3.27
.41 3.52
.29
.04
N 55555
0 15 78 6 1 0 00 6.1 8.8 4.0 .5 555 55 5
300
MEAN
6.5
1.0
5.2
.3
.0 *
0
17
78
4
1
0
S.D.
1.98
.29 2.10
.19
.05
00
11.7
12.1
2.9
.4
N 55555555555
O
Cm
e
Co
ot o
Table 13
Sumciary of Clinical Hematology Data
Females
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV HCH MCHC PLT
X10`/m L
G/DL
%
FL PG % XIOV^L
0 MEAN S.D. N
300 MEAN S.D. N
7.83 .321 5
6.83 * .388 5
14.7 .40 5
13.0 * .81 5
43.6 1.62 5
37.9 * 2.43 5
55.6 1.13 5
55.5 1.31 5
18.8 .56 5
19.0 .46 5
33.8 .48 5
34.2 .29 5
1114 88 5
1110 113 5
Covance 6329-212 3M T-6316.1
DOSE ppm
WBC XIOVm L
Table 13
Summary of Clinical Hematology Data
Females
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
XIOV^L XIOV/JL
MONO
EOSIN
BASO
N-SEG*
XlO'/nL XlOVjiL XIOV^L
LYMPH%
MONO%
EOSIN%
Covance 6329-212 3M T-6316.1
BASO%
MEAN
7.7
.7 6.6
.3
.1 .0 10 84
4
2
0
S.D.
2.85
.31 2.95
.11
.09
.00
6.5 9.1 2.2 1.7
N 55555555555
MEAN
5.8
.6 5.0
.2
.0 *
.0
10
86
3
1
0
S.D.
.78 .30 .93 .10 .00 .00
6.4 5.7 1.1
.4
N 55555555555
O
O c.
Table 14
Sunmary of Clinical Hematology Data
Hales
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) [-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV MCH MCHC PLT
X10`/^L
G/DL
%
FL PG % X10'/<iL
Covance 6329-212 3M T-6316.1
0
MEAN
8.54
15.3
45.7
53.6
17.9
33.5
1240
S.D.
.403
.48 1.34 1.46
.55
.53 156.0
N 10 10 10 10 10 10 10
3 MEAN
S.D. N
8.72 .268
10
15.6 .45 10
46.6 1.17 10
53.5 1.21 10
17.9 .54 10
33.5 .47 10
1140 67.8 10
rro o
30 MEAN S.D. N
8.33 .455 10
15.0 .71 10
44.6 1.87 10
53.6 1.45 10
18.0 .38 10
33.7
.37 10
1143 158.3 10
13 100
IZ
MEAN S.D.
8.18 .347
15.0 .43
44.4 1.57
54.4 1.23
18.4 .51
33.8 .42
1141 80.6
N 10 10 10 10 10 10 10
DOSE ppm
WBC XlOV/iL
Table 14
summary of Clinical Hematology Data
Hales
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
XIOVliL XlOV/iL
HONO
EOSIN
BASO
X10Vi<L XIOV^L XlOV^L
N-SEG%
LYMPH%
MONO%
EOSIN%
Covance 6329-212 3M T-6316.1
BASO%
0
MEAN
7.4
1.2
5.3
.7
.1
.0 17 71
10
2
0
S.D.
1.31
.38 1.27
.19
.04
.00
5.2 7.1 2.8
.6
.0
N 10 10 10 10 10 10 10 10 10 10 10
3
MEAN
10.4
1.5
7.9
.8
.2
.0 15 75
7
2
0
S.D.
3.31
.54 2.79
.29
.11
.00
4.6 6.6 2.3
.7
.0
N 10 10 10 10 10 10 10 10 10 10 10
o 30
o
MEAN
9.2
1.3
7.0
.7
.2
.0 15
75
8
2
0
c,
S.D.
1.85
.41 1.59
.28
.07
.00
4.6 4.7 2.4
.6
.0
N 10 10 10 10 10 10 10 10 10 .10 10
w 100
rw s
MEAN
8.8
1.3
6.7
.7
.1
.0
15 76
8
1
0
S.D.
2.64
.39 2.23
.24
.05
.00
2.6 3.3 2.5
.5
.0
N 10 10 10 10 10 10 10 10 10 10 10
Table 14
Summary of Clinical Hematology Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV MCH MCHC PLT
X10V/iL
G/DL
%
FL PG % XlOV/iL
Covance 6329-212 3M T-6316.1
0 MEAN
S.D. N
8.15 .469 10
15.5 .65 10
45.9 2.09 10
56.4 1.17 10
19.0 .61 10
33.7 .46 10
1040
113 10
3 MEAN
S.D. N
8.12 .411 10
15.3 .64 10
45.3 2.16 10
55.8 1.97 10
18.8 .67 10
33.7 .38 10
1000 222 10
o 30
MEAN
8.01
15.2
45.5
56.8
19.1
33.6
1054
S.D.
.419
.55 1.63 1.72
.80
.45 124
N 10 10 10 10 10 10 10
100 MEAN S.D. N
7.79 .258 9
14.9 .23 9
43.7 .82 9
56.2 1.46 9
19.2 .61
9
34.1 .54 9
1023 56 9
DOSE ppm
WBC XIOV/iL
Table 14
Summary of Clinical Hematology Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESOLFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
XlOV/iL X10V/<L
MONO
EOSIN
BASO
XlOV/iL XlOVfiL XIOVm L
N-SEG%
LYMPH%
MONO%
EOSIN%
Covance 6329-212 3M T-6316.1
BASO%
0
MEAN
6.4
.8 5.1
.4
.1
.0 13
79
62
0
S.D.
1.63
.22 1.44
.13
.04
.00
3.6 . 4.2
1.4
.6
.0
N 10 10 10 10 10 10 10 10 10 10 10
3
MEAN
6.9
.8 5.5
.4
.1
.0 11
81
6
2
0
S.D.
1.77
.43 1.48
.12
.03
.00
4.5 4.8 2.0
.8
.0
N 10 10 10 10 10 10 10 10 10 10 10
o
30
o
MEAN
7.5
.8 6.3
.4
.1
.0 12
80
5
2
0
C-
S.D.
5.43
.22 5.06
.19
.09
.00
5.5 5.9 1.8
.5
.0
W N 10 10 10 10 10 10 10 10 10 10 10
4 100
07
MEAN
6.2
.6 5.1
.4
.1
.0 11
80
6
2
0
S.D.
1.80
.26 1.68
.12
.06
.00
4.8 6.6 3.0
.7
.0
N 99999999999
oo
C.1
A?
to &
Table 15
Summary of C-lfiinniiccaall HHeemmaattoollooggyy EData
kr*<~--
Males
Week 14
DOSB
PPm
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-ETHYL
X 1 0R`B/C/<D
HG/GDBL
HCT
HCT
HCV
PL m c h
MEAN S.D. N
mean S.D.
N
8-32 838 10
8.38 <U1 10
15.2 1.18 10
IS.o
64 10
44.3 1.23
10
44.1
1.62
10
S3. 4
1.55 10
S2.5 1.35 10
PG
18.3 .80 10
17.9 .53 10
Clic %
. DDT X10Vm ,
34.2 45 10
34.0 31 10
1094 94.e
10
1094 90.4
10
COVan3* *'129-228 3M l''63l|218
DOSE ppm
Table 15
Summary of Clinical Hematology Data
Males
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WBC XIOVjiL
N-SEG LYMPH XlO'/^L XIOV/iL
MONO
EOSIN
BASO
X10V/iL XIOV^L X10V/iL
N-SEG%
LYMPH%
MONO%
EOSIN%
Covance 329-228 3M T-6316.1
BASO%
MEAN
10.4
1.3
7.9
.9
.3
.0
13
76
9
3
0
S.D.
2.18
.28 2.04
.23
.12
.00
2.6 . 5.2 2.9 1.3
.0
N 10 10 10 10 10 10 10 10 10 10 10
MEAN
10.2
1.3
7.5
1.1
.3
.0
13
74
11
2
0
S.D.
2.12
.39 1.72
.50
.18
.03
4.1 4.4 3.9 1.3
.0
N 10 10 10 10 10 10 10 10 10 10 10
O
C-;
Table IS
Summary of Clinical Hematology Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
RBC HGB HCT MCV MCH MCHC PLT
X10`/ML
G/DL
%
FL PG % XIOV^L
Covance 6329-228 3M T-6316.1
MEAN S.D. N
7.82 .358 10
14.7 .73 10
43.1 2.10 10
55.1 1.05 10
18.8 .53 10
34.2 .45 10
1064 88 10
MEAN S.D. N
8.01 .350 10
15.2 .39 10
44.2 1.44 10
55.3 1.32 10
19.0 .53 10
34.4 .52 10
1112 83 10
o
c>
ra
13 GO
Table 15
Summary of Clinical Hematology Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WBC XlO'/^iL
N-SEG
LYMPH
X10*/i<L XIOV^I*
MONO
EOSIN
BASO
X10V//L XIOV^L X10V/iL
N-SEG%
LYMPH%
MONO%
EOSIN%
Covance 6329-228 3M T-6316.1
BASO%
MEAN
7.3
.8 5.8
.5
.2
.0 12 78
7
3
0
S.D.
2.61
.38 2.24
.16
.09
.00
4.3 4.7 1.7
.9
0
N 10 10 10 10 10 10 10 10 10 10 10
MEAN
6.5
.9 5.0
.4
.2
.0 15
75
7
3
0
S.D.
1.23
.20 1.37
.17
.06
.00
5.0 8.7 3.7 1.0
0
N 10 10 10 10 10 10 10 10 10 10 10
cO
e-
?w
M (2
Table 16
Summary of Clinical Hematology Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV MCH MCHC PLT
X10`/^L
G/DL
%
FL PG % X10V/iL
Covance 6329-212 3M T6316.1
0 MEAN S.D. N
8.33 .445 10
14.8 .47 10
44.2 1.41 10
53.1 1.63 10
17.8 .66 10
33.4 .40 10
1270 107.3 10
3
MEAN
8.19
14.6
44.0
53.8
17.9
33.3
1096 *
S.D.
.879
1.46
4.15
1.83
.66
.45 100.5
N 10 10 10 10 10 10 10
30
MEAN
8.27
14.9
44.0
53.2
18.0
33.8
1190
S.D.
.374
.51 1.12 1.98
.78
.44 131.4
N 10 10 10 10 10 10 10
c - 100
MEAN
8.22
14.5
42.9
52.2
17.6
33.7
1206
u S.D.
.398
.59 2.12 2.24
.77
.44
55.6
N 10 10 10 10 10 10 10
O c f. v
IA
DOSE ppm
WBC XlOV/iL
Table 16
Summary of Clinical Hematology Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE <98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
XIO'/aaL XlOV/iL
MONO
EOSIN
BASO
XIOVaaL XIOVaaL XIOVaaL
N-SEG% LYMPH%
MONO%
EOSIN%
Covance 6329-212 3M T6316.1
BASO%
0
MEAN
7.9
1.4
5.5
.8
.2
.0 19
69
10
2
0
S.D.
1.77
.34 1.52
.19
.06
.00
4.2 4.7 1.8
.4
.0
N 10 10 10 10 10 10 10 10 10 10 10
3
MEAN
7.9
1.4
5.6
.7
.2
.0 17
71
92
0
S.D.
1.62
.65 1.14
.23
.08
.00
4.5 5.3 4.1
.7
.3
N 10 10 10 10 10 10 10 10 10 10 10
30
MEAN
8.8
2.0
5.8
.8
.2
.0 22
68
92
0
S.D.
1.91
.98 1.22
.27
.07
.00
8.3 8.7 2.2
.8
,0
N 10 10 10 10 10 10 10 10 10 10 io'
100
MEAN
8.9
2.4
5.6
.8
.1
.0
24
65
92
0
S.D.
3.06
2.34
1.27
.28
.04
.00
11.6
11.7
2.4
.7
.3
N 10 10 10 10 10 10 10 10 10 10 10
Table 16
Summary of Clinical Hematology Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV MCH MCHC PLT
X10`/m L
G/DL
%
FL PG % XIOV^L
Covance 6329-212 3M T6316.1
0
MEAN S.D. N
7.93 .316 10
15.3 .29 10
45.1 1.04 10
56.9 1.76 10
19.3 .76 10
33.9 .38 10
1076 96.6 10
3
MEAN
7.54 * 14.7 * 43.2 * 57.4
19.5
34.0
987
S.D.
.243
.50 1.23 1.88
.82
.49 176.1
o N 10 10 10 10 10 10 10
o 30
MEAN
7.78
14.9
43.9
56.4
19.1
33.9
968
S.D.
.396
.46 1.38 1.99
.80
.49
94.2
N 10 10 10 10 10 10 10
u
t4
100 MEAN
7.25 * 14.1 * 41.0 * 56.5
19.4
34.4
996
S.D.
.268
.61 1.82 1.74
.51
.56 103.9
N 10 10 10 10 10 10 10
DOSE ppm
WBC XlO'/AiL
Table 16
Summary of Clinical Hematology Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
X105//rL X10V/JL
MONO
EOSIN
BASO
XIOVa/L x i o V m l XIOV^L
N-SEG% LYMPH%
MONO%
EOSIN%
Covance 6329-212 3M T6316.1
BASO%
0
MEAN
5.1
.7 3.7
.6
.1
.0 14
71
12
2
0
S.D.
1.29
.17 1.39
.21
.00
.03
5.2 10.3
5.5
6 .7
N 10 10 10 10 10 10 10 10 10 10 10
3
MEAN
5.2
.7 3.9
.5
.1
.0 14
74 10
2
0
S.D.
1.85
.24 1.55
.17
.03
.00
2.8 4.0 3.2
.9 .3
N 10 10 10 10 10 10 10 10 10 10 10
30
MEAN
4.8
.8 3.3
.5
.1
.0 18
69 11
2
0
O
S.D.
1.20
.22
.98
.21
.03
.00
4.6 7.5 4.1
.7
.4
N 10 10 10 10 10 10 10 10 10 10 10
100
MEAN
4.9
.8 3.5
.4
.1 .0 17 72
8
2
0
to
S.D. .69 .28 .73 .07 .03 .00
5.7 6.7 2.2
.5 .4
N 10 10 10 10 10 10 10 10 10 10 10
to
Male -WEEK DIETARY CARCINOGENICITY
_f
Do s e Ppm
mean
S.D. N
mean
S.D.
N
RBC Xl 0`/uL
8.22 430 10
8.28 487 10
P. ER-F,,LnUcOiRNOOOGCETNAINCEISTtY' STUDY WITH NARROW RANGE PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
HHGGBB Gg //dml
HCT t
MCV
FL MC
PG
MCHC
15.2 .67 10
*4.8 .78 10
<4.6 1.98 10
<3. g 2-19 10
54.3 1.63 10
53.1 1.28 10
18.5 62 10
17.9 54 10
34.0 36 10
33.8 * .39 10
PjLT* xi o y ^
1083 109.2 10 1112 83.2 10
C V ance 6 3 2 9 -2 2 8
3M 3 1 f 2i8
DOSE ppm
Table 17
Summary of Clinical Hematology Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WBC
N-SEG
LYMPH
XIO'/fiL XIOV/^L X10V#<L
MONO
EOSIN
BASO
XIOV^L XIOV/^L XIOV^L
N-SEG% LYMPH%
MONO%
EOSIN%
Covance 6329-228 3M T6316.1
BASO%
0
MEAN
8.6
1.7
5.7
1.0
.2
.0 19
66
11
3
0
S.D.
1.85
.81 1.12
.34
.13
.04
5.4 8.0 4.0 1.6
N 10 10 10 10 10 10 10 10 10 10 10
1
MEAN
8.9
1.5
5.9
1.2
.2
.1 17
66
14
2
1
S.D.
1.34
.28 1.17
.67
.08
.13
4.0 7.6 6.2 1.0
N 10 10 10 10 10 10 10 10 10 10 10
C
o
to to to m
Table 17
Summary of Clinical Hematology Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV MCH MCHC PLT
XIOViiL
G/DL
%
FL PG f XIOV^L
0 MEAN S.D. N
1 MEAN S.D.
7.31 .267 10
7.63 .451
13.9 .75 10
14.7 * .54
40.6 1.79 10
42.5 * 1.93
55.6 1.46 10
55.8 1.45
19.1 .66 10
19.3 .58
34.3 .50 10
34.6 .41
1038 101 10
1098 161
Covance 6329-228 3M T6316.1
DOSE ppm
WBC XIOVpL
Table IT
Summary of Clinical Hematology Data
Females
Meek 21
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
X10V/iL X10Va<L
MONO
EOSIN
BASO
XIOVaL XlOVnL X10V/aL
N-SEG% LYMPH
MONO
EOSIN
Covance 6329-228 3M T6316.1
BASO
0
MEAN
6.4
1.0
4.6
.6
.2
.0 15
73
92
0
S.D.
2.32
.72 1.46
.28
.15
.00
5.7 7.7 2.3 1.2
N 10 10 10 10 10 10 10 . 10 10 10 10
1
MEAN
5.8
.9 4.2
.5
.1
.0 16 72
92
0
S.D.
1.90
.30 1.63
.21
.04
.00
5.8 9.9 3.6
.8
N 10 10 10 10 10 10 10 10 10 10 10
oc
CO
>1
Table 18
Summary of Clinical Hematology Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) I-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV MCH MCHC PLT
X10`/a<L
G/DL
%
FL PG % XIO'/^L
Covance 6329-212 3M T6316.1
0 MEAN S.D. N
8.01 1.004
10
14.5 1.52 10
43.3 4.50 10
54.2 2.32 10
18.2 .78 10
33.4 .30 10
1238 229.3 10
3 MEAN S.D. N
8.42 .498 10
15.2 .76 10
45.3 2.79 10
53.8 1.88 10
18.1 .52 10
33.6 .61 10
1210 176.3 10
30 MEAN S.D. N
8.39 .585 10
14.8 1.12 10
43.8 3.17 10
52.2 1.82 10 '
17.6 .80 10
33.8 .56 10
1199 97.5 10
O
100 MEAN
8.45
14.7
43.3
51.3 * 17.4 * 33.9
1129
o
S.D.
.454
.68 1.73 1.06
.45
.55 184.1
Ct,--.1 N 10 10 10 10 10 10 10
Cj
DOSE ppm
WBC XIOVwL
Table 18
Summary of Clinical Hematology Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
XlO'/iiL XIO'/^L
MONO
EOSIN
BASO
x i o '/m l XIOViiL x i o 5/m l
N-SEG% LYMPH%
MONO%
EOSIN%
Covance 6329-212 3M T6316.1
BASO%
0
MEAN
8.5
2.4
4.9
1.0
.2
.0 29
58 12
2
0
S.D.
2.14
.88 1.26
.35
.08
.00
5.1 5.4 3.4
.7
.3
N 10 10 10 10 10 10 10 10 10 10 10
3
MEAN
7.9
1.9
4.9
.9
.1
.0 24
62 11
2
0
S.D.
1.11
.73
.70
.28
.05
.03
6.9 6.6 3.2
.7
3
N 10 10 10 10 10 10 10 10 10 10 10
30
MEAN
8.8
2.5
5.5
.7
.2
.0 28
62
82
0
S.D. .90 .79 1.01 .43 .07 .00 8.3 8.8 4.6 .7 .0
N 10 10 10 10 10 10 10 10 10 10 10
100
MEAN
7.5
1.8
4.7
.8
.2
.0 25
62 11
2
0
c-
S.D.
2.02
.53 1.74
.19
.05
.00
7.1 9.5 3.6
.6
.3
N 10 10 10 10 10 10 10 10 10 10 10
CD
CO
Table 18
Summary of Clinical Hematology Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV MCH MCHC PLT
X10V//L
G/DL
%
FL PG % XIOVwL
Covance 6329-212 3M T6316.1
0 MEAN S.D. N
7.23 1.388
10
14.2 1.95 10
41.5 6.15 10
58.2 4.19 10
20.0 1.81 10
34.4 .64 10
998 125
10
3 MEAN
S.D. N
7.42 .589
10
14.3 1.03 10
42.4 2.99 10
57.2 1.78 10
19.3 .85
10
33.7 * .56 10
935 125
10
30
MEAN
7.44
14.6
42.8
57.6
19.6
34.0
918
S.D.
.979
1.86
5.57
2.13
.83 .51 133
N 10 10 10 10 10 10 10
c 100
Co
MEAN
6.92
13.6
39.4
57.1
19.7
34.6
907
S.D.
1.008
1.62
4.74
2.24
.79
.43 80
N 10 10 10 10 10 10 10
o
WBC XIOViiL
Table 18
Summary of Clinical Hematology Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
XIOV/iL XIOV/jL
MONO
EOSIN
BASO
XIOV^L XIOV^L XlOV/iL
N-SEG% LYMPH%
MONO%
EOSIN%
Covance 6329-212 3M T6316.1
BASO%
0
MEAN
4.5
1.1
2.7
.6
.1
.0 25
60
13
2
0
S.D. .59 .39 .40 .08 .03 .00 6.8 6.8 1.2 .5 .4
N 10 10 10 10 10 10 10 10 10 10 10
3
MEAN
4.8
1.5
2.6
.6
.1
.0 26 59
12
2
0
S.D.
1.95
1.60
.74
.34
.03
.03
13.8
14.8
1.9
.9
.3
N 10 10 10 10 10 10 10 10 10 10 10
30
O
MEAN
5.7
1.2
3.8
.5
.1
.0 22
66
9
3
0
Cj
S.D.
1.60
.49 1.43
.20
.07
.00
7.4 8.4 3.8 1.4
.0
& N 10 10 10 10 10 10 10 10 10 10 10
fvi' K
100
MEAN
5.8 *
1.6
3.4
.7
.2
.0 28
58
11
3
0
S.D. .74 .33 .63 .19 .08 .00
4.6 5.7 4.0 1.2
.3
H - N 10 10 10 10 10 10 10 10 10 10 10
Table 19
Summary of Clinical Hematology Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
RBC HGB HCT MCV MCH MCHC PLT
XIOV/iL
G/DL
%
FL PG % XlOVL
0 MEAN S.D. N
1 MEAN S.D. N
8.20 .530 10
8.42 .439 10
15.2 .78 10
15.2 .71 10
42.6 2.22 10
43.4 1.97 10
52.0 1.89 10
51.6 2.54 10
18.5 .69 10
18.1 1.04 10
35.6 .24 10
35.2 * .38 10
1171 158 10
1131 185 10
Cvance 6329-228 3M T6316.1
WBC XIO'/^L
Table 19
Summary of Clinical Hematology Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
N-SEG
LYMPH
X10V/iL XIOVAiL
MONO
EOSIN
BASO
X10V/iL XlOV/iL XIOViiL
N-SEGt LYMPH%
MONO*
EOSIN*
Covance 6329-228 3M T6316.1
BASO*
0
MEAN
6.8
2.0
3.9
.8
.1
.0 29
57
11
2
0
S.D.
1.64
.73 1.29
.34
.05
.03
8.6 10.4
4.7
.9
N 10 10 10 10 10 10 10 10 10 10 10
1
MEAN
6.7
2.0
3.8
.8
.1
.0 28
57
12
2
0
S.D.
2.12
1.17
.93
.29
.05
.00
7.3 6.7 2.7
.6
N 10 10 10 10 10 10 10 10 10 10 10
Cm rv
C3
Table 19
Summary of Clinical Hematology Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
RBC HGB HCT MCV MCH MCHC PLT
X10`/m L
G/DL
t
FL PG XIOV^L
MEAN S.D. N
MEAN S.D. N
7.71 .362 10
7.78 .435 10
14.9 .50 10
14.9 .46 10
41.4 1.77 10
41.6 1.16 10
53.8 1.63 10
53.5 1.75 10
19.4 .67 10
19.2 .61 10
36.0 .46 10
35.7 .41 10
941 117.1
10
1053 * 102.5 10
Covance 6329-Z20 3M T6316.1
o o c-
Table 19
Summary of Clinical Hematology Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
WBC XI07/iL
N-SEG
LYMPH
XIOV^L XIOV^L
MONO
EOSIN
BASO
x i o V a<l XIOV^L XIOV^L
N-SEG% LYMPH*
MONO*
EOSIN*
Covance 6329-228 3M T6316.1
BASO*
MEAN
5.2
1.4
3.2
.6
.1
.0
27
60
11
2
0
S.D.
1.64
.48 1.16
.13
.03
.00
4.7 5.8 2.3
.8
N 10 10 10 10 10 10 10 10 10 10 10
MEAN
5.1
1.3
3.2
.6
.1
.0 26
60
12
2
0
S.D.
2.18
.73 1.66
.24
.04
.03
8.6 9.5 4.6
.7
N 10 10 10 10 10 10 10 10 10 10 10
<r>
b
Ul
Table 20
Summary of Clinical Chemistry Data
Hales
Week 4
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
PCOAO IU/G
Covance 6329-212 3M T-6316.1
0 MEAN S.D. N
7 3.8 5
3 MEAN S.D. N
8 2.5 5
30 MEAN S.D. N
9 1.7 5
rs
100 MEAN
6
S.D.
1.9
N5
300
MEAN
14 *
S.D. N
3.6 5
Table 20
Summary of Clinical Chemistry Data
Females
Week 4
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
PCOAO IU/G
0 MEAN S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
300 MEAN S.D.
3 2.7 5
5 1.6 5
4 2.7 5
5 1.6 5
15 * 7.9
Covance 6329-212 3M T-6316.1
o
C
Co fs)
m
Table 21
Summary of Clinical Chemistry Data
Males
Week 4
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
PCOAO IU/G
MEAN S.D. N
MEAN S.D. N
7 2.6 5
7 3.8 5
Covance 6329-228 3M T-6316.1
fccroo
Table 21
Summary of Clinical Chemistry Data
Females
Week 4
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
PCOAO IU/G
0 MEAN S.D. N
1 MEAN S.D. N
3 1.1 5
4 2.3 5
Covance 6329-228 3M T-6316.1
DOSE ppm
Table 22
Summary of Clinical Chemistry Data
Males
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
GLU MG/DL
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL MG/DL
0
MEAN
106
13
.8 6.7 4.6 2.2
S.D.
6.3 1.9 .13 .48 .19 .31
N 555555
.1 53 .08 13.3
55
300 MEAN S.D. N
94 *
18 *
.7
7.1
5.5 *
1.6 *
.5 *
6.2 2.2 .08 .61 .38 .30 .09
5555555
7* 5.2 5
Covance 6329-212 3M T-6316.1
O C-
in O
DOSE ppm
Table 22
Summary of Clinical Chemistry Data
Males
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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
0 MEAN S.D. N
300 MEAN S.D.
113 24.8 5
179 * 55.6
42 7.0 5
271 * 213.8
2 10.5 1.6 .21 55
1 10.4 1.2 .26
7.8 .79 5
7.7 .34
148 1.5 5
147 1.6
5.7 .26 5
5.6 .32
103 1 5
103 2
Covance 6329-212 3M T-6316.1
Table 22
Summary of Clinical Chemistry Data
Males
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
PCOAO IU/G
Covance 6329-212 3M T-6316.1
MEAN S.D. N
300 MEAN S.D. N
9 3.5 5
26 * 5.3 5
cc *
Cj
cn w
DOSE ppm
Table 22
Summary of Clinical Chemistry Data
Females
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
GLU MG/DL
UN HG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL MG/DL
0
MEAN
109
13
.8 7.3 5.4 1.9
.3 69
S.D.
8.8 2.3 .11 .31 .29 .19 .09 16.2
N 5 5 5 5 5 5' 5 5
300
MEAN
86 *
22 *
.8
7.7
6.2 *
1.5
.4 11 *
S.D. 20.0 3.7 .10 1.00 .63 .40 .08
4.0
N 55 555 555
Covance 6329-212 3M T-6316.1
O
*4 m
CJ
DOSE ppm
Table 22
Summary of Clinical Chemistry Data
Females
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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
0 MEAN S.D. N
300 MEAN S.D. N
129 21.6 5
145 78.4 5
42 19.8
5
94 67.7
5
1 11.1 1.1 .38 55
1 11.2 1.7 .40 55
8.4 1.99
5
8.6 1.22
5
148 2.3 5
149 2.8 5
5.9 .61 5
5.6 .34 5
103 2 5
105 1 5
Covance 6329-212 3M T-6316.1
Table 22
Summary of Clinical Chemistry Data
Females
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE PPm
PCOAO IU/G
0 MEAN S.D. N
300 MEAN S.D. N
3 2.7 5
26 * 6.6 5
Covance 6329-212 3M T-6316.1
o
c-.
iw
m m
DOSE ppm
Table 23
Summary of Clinical Chemistry Data
Males
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-212 3M T-6316.1
0
MEAN
111
13
.7 7.4 5.0 2.4
.2 82
S.D. 18.0 1.4 .13 .32 .16 .23 .12 14.4
N 10 10 10 10 10 10 10 10
3
MEAN
101
14
.7
7.1
4.7 *
2.4
.2
61 *
S.D.
5.7 2.2 .06 .28 .14 .21 .08
6.8
N 10 10 10 10 10 10 10 10
30
MEAN
102
14
.7 7.1 4.8 2.4
.1 53 *
S.D.
8.6 2.0 .14 .36 .18 .31 .10
7.9
N 10 10 10 10 10 10 10 10
'O
100 MEAN
94 *
15
.6 7.2 5.1 2.2
.2 29 *
c
S.D.
7.0 1.6 .05 .31 .25 .25 .08
9.8
C.1 N 10 10 10 10 10 10 10 10
01
o
DOSE ppm
Table 23
Summary of Clinical Chemistry Data
Males
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-212 3M T-6316.1
0 MEAN S.D.
N
128 32.7 10
41 6.9
10
0 .4
10
10.8 .37 10
7.7 .62 10
149 1.7
10
6.5 .41 10
105 1.3
10
3 MEAN S.D. N
130 27.0 10
42 6.1
10
0 .7
10
10.6
.28 10
7.8 .69 10
148 1.7
10
6.2 .28
10
104 2.4
10
30 MEAN S.D.
N
116 31.0 10
46 14.2 10
0 .3
10
10.8 .28 10
7.8 .55 10
148
1.5 10
6.1 * .34
10
106 2.1
10
100
MEAN
111
47
0 10.6
7.7
148
6.1 *
106
o
S.D. N
32.3
11.1
1.3 .35
.42
1.7 .35
2.4
10 10 10 10 10 10 10 10
at -
Hi
DOSE ppm
Table 23
Summary of Clinical Chemistry Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-212 3M T-6316.1
0
MEAN
106
13
.8 8.3 6.1 2.2
.2 95
S.D. 10.4 1.5 .12 .47 .43 .21 .10 29-6
N 10 10 10 10 10 10 10 10
3
MEAN
108
14
.7 8.0 6.0 2.0
.2 80
S.D.
7.9 2.3 .10 .39 .43 .12 .18 12.9
N 10 10 10 10 10 10 10 10
30
MEAN
97
16
.8 7.8 5.8 2.0
.1 69 *
S.D. 11.9 3.8 .16 .53 .37 .24 .13 18.3
N 10 10 10 10 10 10 10 10
100
MEAN
94 *
19 *
.7
8.1
6.1
2.0
.2 58 *
S.D.
9.9 4.3 .12 .31 .19 .32 .12 22.9
O N 10 10 10 10 10 10 10 10
C
Cj
in 00
DOSE
Table 23
Summary of Clinical Chemistry Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-212 3M T-6316.1
MEAN S.D. N
110 30.2 10
39 18.5 10
0 1.0 10
11.3 .37 10
7.0 1.22
10
149 2.4
10'
6.0 .80 10
106
2.0 10
MEAN S.D. N
96 14.8 10
32 6.5
10
0 .5
10
11.4 .38
10
7.3 .95 10
148 1.8
10
6.1 .59 10
105 1.2
10
MEAN S.D.
N
118 16.0 10
34 6.0
10
0 .5
10
10.8 * .46
10
6.8 1.00
10
149 2.2
10
5.8 .35 10
106 1.4
10
100 MEAN S.D. N
87 17.1 10
33 4.7
10
1 1.5 10
11.1 .27 10
6.8 .74 10
149 2.0
10
5.9 .37 10
106 2.2
10
o
V r *
C/f
C3
Table 23
Sunanary of Clinical Chemistry Data
Males
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
PCOAO IU/G
0 MEAN S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D.
7 .9
5
7 1.4 5
5 1.6 5
6 2.7
Covance 6329-212 3M T-6316.1
Table 23
Summary of Clinical Chemistry Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE PPm
PCOAO IU/G
Covance 6329-212 3M T-6316.1
0 MEAN S.D. N
4 1.9 5
3 MEAN S.D. N
5 1.6 5
o 30
o C-3-)
MEAN S.D. N
4 2.9 5
to
m
100 MEAN
8
S.D.
3.3
N5
6
> W
0 ') to
DOSE ppm
Table 24
Summary of Clinical Chemistry Data
Males
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-228 3M T-6316.1
MEAN
113
14
.7 6.9 4.8 2.1
.0 59
S.D.
9.6 2.1 .10 .40 .22 .28 .05
7.0
N 10 10 10 10 10 10 10 10
MEAN
114
13
.6 7.0 4.7 2.3
.0 63
S.D.
7.4 2.1 .11 .32 .19 .26 .05 12.8
N 10 10 10 10 10 10 10 10
DOSE
Table 24
Summary of clinical Chemistry Data
Hales
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-228 3M T-6316.1
MEAN S.D. N
MEAN S.D. N
110 21.4 10
111 14.9 10
39 8.1
10
48 21.2 10
2 2.1 10
3 2.2 10
10.6 .19 10
10.6 .24 10
7.3 .63 10
7.0 .31 10
147 .8
10
147 .8
10
5.9 .39 10
6.3 * .31 10
106 1.9
10
107 .6
10
o o C'
N?
& a
DOSE ppm
Table 24
Summary of Clinical Chemistry Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
GLU MG/DL
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL MG/DL
0
MEAN
114
14
.8 8.2 6.1 2.1
.2 94
S.D.
8.7 2.3 .14 .60 .52 .22 .16 22.1
N 10 10 10 10 10 10 10 10
1
MEAN
110
15
.7 7.9 5.8 2.1
.1 88
S.D.
3.8 2.4 .12 .68 .66 .27 .13 20.3
N 10 10 10 10 10 10 10 10
Covance 6329-228 3M T-6316.1
c-
cn
DOSE ppm
Table 24
Summary of Clinical Chemistry Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
AST/SGOT ALT/SGPT
IU/L
IU/L
GGT IU/L
CA MG/PL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
0 MEAN S.D. N
1 MEAN S.D.
110 58.6 10
108 24.1
44 24.9 10
44 19.1
2 1.3 10
2 2.0
11.4 .54 10
11.2 .29
6.0 .44 10
6.4 * .43
145 1.6
10'
147 * .8
5.8 .38 10
6.0 .36
106 1.8
10
107 2.2
Covance 6329-228 3M T-6316.1
) m
Table 24
Summary of Clinical Chemistry Data
Hales
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
PCOAO IU/G
0 MEAN S.D. N
1 MEAN S.D. N
6 1.3 5
5 1.1 5
Covance 6329-228 3M T-6316.1
Table 24
Summary of Clinical Chemistry Data
Females
Meek 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE
pprn
PCOAO
IU/G
Covance 6329-228 3M T-6316.1
MEAN S.D. N
3 .9
5
MEAN S.D. N
5 1.6 5
oo
C'-
cn
DOSE ppm
Table 25
Summary of Clinical Chemistry Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-212 3M T6316.1
892T00
0
MEAN
106
11
.6 7.4 4.6 2.7
S.D.
11.8
1.2 .13
.31
.25
.13
N 10 10 10 10 10 10
.1 .13 10
3
MEAN
108
13
.7 7.4 4.8 2.6
S.D.
12.1
1.8 .12
.43
.39
.19
N 10 10 10 10 10 10
.2 .11 10
30 MEAN S.D. N
98 13
.7
7.2
4.7
2.5 *
.1
6.2 1.7 .10 .51 .39 .20 .10
10 10 10 10 10 10 10
100 MEAN S.D. N
95 *
15 *
.6
7.7
5.3 *
2.4 *
.1
7.3 1.6 .11 .32 .25 .28 .11
10 10 10 10 10 10 10
96 30.3 10
86 19.8 10
68 * 18.8 10
42 * 16.2 10
DOSE ppm
Table 25
Summary of Clinical Chemistry Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-212 3M T6316.1
0 MEAN S.D. N
114 28.0 10
40 13.8
10
i 1.3 10
10.8 .38 10
7.4 .82 10
149 1.9
10
6.7 .48 10
106 1
10
3
MEAN
119
42
0 10.6 6.9 147 6.2 105
S.D.
38.3
21.2
.7 .39
.66
2.3 .48
2
o N 10 10 10 10 10 10 10 10
o
c*<
30 MEAN
114
57
1 10.6 7.2 147 6.3 106
S.D.
38.7
31.0
1.0 .34
.40
1.4 .37
1
CD N 10 10 10 10 10 10 10 10
C 3 100
MEAN
165
94
1 10.7 7.2 147 6.3 106
S.D.
192.1
113.7
.8 .32
.40
1.4 .35
1
N 10 10 10 10 10 10 10 10
00
Co
4V-.^
o
DOSE ppm
Table 25
Summary of Clinical Chemistry Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
GLU MG/DL
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL MG/DL
0
MEAN
101
15
.8 8.0 5.8 2.2
S.D. 13.4 3.7 .24 .65 .53 .23
N 10 10 10 10 10 10
3
MEAN
103
14
.7 8.2 5.8 2.4
S.D.
7.3 2.2 .11 .54 .57 .28
N 10 10 10 10 10 10
30
MEAN
107
16
.6 8.0 5.8 2.2
S.D.
8.9 3.7 .08 .61 .41 .28
N 10 10 10 10 10 10
100 MEAN S.D. N
92
21 *
.8
8.5
6.2
2.4
7.1 7.0 .21 .50 .30 .25
10 10 10 10 10 10
.2 87 .10 14 10 10
.2 104 .14 21 10 10
.2 86 .12 19 10 10
.2 71 .14 20 10 10
Covance 6329-212 3M T6316.1
DOSE ppm
Table 25
Summary of Clinical Chemistry Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 S329-212 3M T6316.1
0 MEAN S.D. N
122 30.0 10
44 19.3 10
1 1.1 10
11.0 .41 10
6.0 .44 10
147 2.9
10
6.1 .57 10
105 2
10
3 MEAN S.D. N
102 23.6 10
41 17.7 10
2 4.7 10
11.0 .41 10
5.8 .76 10
147 .9
10
5.7 .54 10
105 1
10
30 MEAN S.D. N
104 22.1 10
37 10.8 10
2 1.4 10
11.0 .53 10
6.1 .92 10
147 1.7
10
6.1 .69 10
107 1
10
100
MEAN
105
47
1 11.2 6.2 146 5.8 104
U
S.D.
42.4
17.3
1.3 .24
.63
1.6 .71
2
N 10 10 10 10 10 10 10 10
CO
Table 26
Summary of Clinical Chemistry Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-228 3M T6316.1
MEAN
103
12
.6 6.9 4.6 2.2
.1
75
S.D. 10.1 1.2 .06 .32 .17 .28 .05 12.5
N 10 10 10 10 10 10 10 10
MEAN
111 *
13
.6 7.1 4.6 2.5
.2 84
o S.D. 7.3 .9 .04 .29 .18 .25 .05 17.1
o N 10 10 10 10 10 10 10 10
Cm
fv
vi
DOSE ppm
Table 26
Summary of Clinical Chemistry Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
AST/SGOT ALT/SGPT
IU/L
IU/L
GGT IU/L
MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Covance 6329-228 3M T6316.1
0 MEAN S.D. N
120 21.8 10
43 23.3
10
2 .8
10
10.6 .16
10
7.0 .41 10
146 1.2
10
5.9 .34 10
105 2
10
1
MEAN
110
45
1
10.8 *
7.0
147
6.3 *
105
S.D.
20.4
18.1
.8 .20
.47
1.1 .29
2
N 10 10 10 10 10 10 10 10
o
C4
vi
CO
DOSE ppm
Table 26
Summary of Clinical Chemistry Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-228 3M T6316.1
0
MEAN
106
14
.7 8.3 6.1 2.2
.2 117
S.D.
8.0 1.7 .03 .41 .32 .23 .00 27.5
N
10
10
10
10
10
10 ,
10
10
1
MEAN
104
13
.7 *
8.2
5.9
2.3
.2 111
S.D.
7.2 2.2 .05 .45 .64 .50 .06 33.8
o N 10 10 10 10 10 10 10 10
Cj
si
DOSE ppm
Table 26
Summary of Clinical Chemistry Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-228 3M T6316.1
0
MEAN
S.D.
N
115 50.2 10
58 38.8 10
2 1.9 10
11.3 .38 10
5.6 .59 10
144 1.3
10
5.2 .50 10
103 2
10
1
MEAN
178
96
4 11.2
6.1
146 *
5.5
104
S.D.
168.9
113.8
6.3 .43
.59
1.3 .54
2
N 10 10 10 10 10 10 10 10
<-*>
6
to
to
*\i
to
c*
d
DOSE ppm
Table 27
Summary of Clinical Chemistry Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
GLU MG/DL
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
CHOL MG/DL
0
MEAN
115
13
.6 7.3 4.4 2.9
S.D.
11.7
1.5 .10
.38
.25
.45
N 10 10 10 10 10 10
,i 146 .10 70.8 10 10
3
MEAN
111
12
.6 7.6 4.7 2.9
S.D. 10.8 1.6 .11 .67 .49 .48
N 10 10 10 10 10 10
.2 119 .13 36.1 10 10
30
MEAN
116
14
.7 7.3 4.7 2.6
.2 92 *
S.D.
9.4 2.2 .18 .32 .18 .35 .13 38.3
N 10 10 10 10 10 10 10 10
100
MEAN
113
14
.6
7.7
5.3 *
2.4 *
.1
S.D.
13.7
1.0 .11
.35
.30
.27
.09
N 10 10 10 10 10 10 10
49 * 21.4 10
Covance 6329-212 3M T6316.1
oO
Cu
sai
DOSE ppm
Table 27
Summary of Clinical Chemistry Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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
0 MEAN S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
117 23.7 10
108 22.9 10
105 25.4 10
83 * 16.2 10
40 9.4
10
48 14.4 10
51 19.2 10
68 * 26.5 10
4 3.5 10
11.1 .41 10
3 2.7 10
11.0
.35 10
4 4.5 10
10.9 .30 10
6
4.2 10
10.9 .20 10
6.5 .87 10
6.7 .53 10
6.8 .62 10
6.5 .37 10
150 1.7
10
150 1.6
10
150 1.9
10
148 * 1.6
10
6.4 .36 10
6.5 .52 10
6.5 .42 10
6.3 .45 10
109 2
10
108 1
10
109 1
10
109 2
10
Covance 6329-212 3M T6316.1
DOSE ppm
Table 27
Summary of Clinical Chemistry Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-212 3M T6316.1
0
MEAN
108
13
.7 8.0 5.9 2.1
S.D. 14.0 3.0 .12 .70 .58 .25
N 10 10 10 10 10 10'
.3 116 .16 22.1 10 10
3
MEAN
105
13
.7 8.2 5.8 2.5
.2 119
S.D. 13.0 1.6 .17 .55 .57 .40 .19 39.1
r> N 10 10 10 10 10 10 10 10
30
C4
MEAN S.D.
93 *
14
.8 8.4 5.9 2.4
7.8 2.1 .09 .37 .22 .33
.3 94 .25 23.9
N 10 10 10 10 10 10 10 10
go
100
MEAN
103
16
.6
8.5
5.9
2.6 *
.1
88
S.D. 11.3 4.2 .08 .42 .22 .37 .12 23.2
N 10 . 10 10 10 10 10 10 10
DOSE ppm
Table 27
Summary of Clinical Chemistry Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESUIiFONAMIDO ETHANOL 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 6329-212 3M T6316.1
0
MEAN S.D. N
107 33.7 10
43 16.5 10
2 1.8 10
li.i .44 10
5.8 .73 10
148 2.2
10
5.6 .51 10
106 3
10
3
MEAN
104
48
2 11.2 5.8 149 6.1 108
S.D. N
27.4 10
22.0 10
2.8 10
.43 10
.44 1.7 .45 2 10 10 10 10
30
MEAN
125
66
5 11.1 6.2 150 5.9 107
S.D.
56.9
72.0
6.8 .42
.85
3.9 .56
2
CD N 10 10 10 10 10 10 10 10
100
MEAN S.D. N
89 19.9 10
63 26.1 10
4 4.0 10
11.3 .29 10
5.8 .48 10
147 1.9
10
5.7 .40 10
107 2
10
O
Co
K CJ
o
Table 28
Summary of Clinical Chemistry Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-228 3M T6316.1
MEAN S.D. N
MEAN S.D. N
119 19.5 10
127 13.2 10
12 2.0
10
12 2.3
10
.7 .09 10
.7 .03 10
7.1 .35 10
7.1 .31 10
4.6 .37 10
4.6 .31 10
2.5 .29 10 '
2.5 .30 10
.2 .05 10
.2 .05 10
105 33.8 10
102 42.1 10
DOSE ppm
Table 28
Summary of Clinical Chemistry Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-228 3M T6316.1
0 MEAN S.D. N
108 55.4 10
77 118.8
10
2 1.1 10
10.3 .55 10
6.2 .89 10
149 3.5
10 '
6.1 .58 10
106 3
10
1
MEAN
110
42
1 10.5 6.4 150 6.4 107
S.D.
40.0
12.3
1.3 .34
.53
4.3 .50
3
O N 10 10 10 10 10 10 10 10
O
Cj
QD
o
e
Co
?v
GO
W
Table 28
Summary of Clinical Chemistry Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-228 3M T6316.1
MEAN
113
11
.8 8.4 5.9 2.4
.3 142
S.D. 17.5 1.1 .07 .44 .36 .34 .22 34.0
N
10
10
10
10
10
10
10
10
MEAN
108
14 *
.8
8.5
5.8
2.7
S.D.
8.9 2.5 .07 .47 .40 .41
N 10 10 10 10 10 10
.2 126 .06 20.8 10 10
DOSE ppm
Table 28
Summary of Clinical Chemistry Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL 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 6329-228 3M T6316.1
MEAN S.D. N
100 29.1 10
54 24.7
10
2 1.0 10
11.1 .44 10
5.4 1.05
10
147 4.1
10
5.4 .37 10
102 2.6
10
MEAN
156
72
2 11.0 5.7 147 5.3 104
S.D.
160.1
62.1
2.6 .50 1.14
2.3 .68
3.0
oo N 10 10 10 10 10 10 10 10
C-'
00 CO
Table 29
Summary of Clinical Urinalysis Data
Males
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN FATS
DOSE ppm
U VOL ML
SP GR
U PH
Covance 6329-212 3M T-6316.1
0
MEAN
17.5
1.020
S.D.
10.64
.0086
N 55
7.0 .35 5
300
MEAN
28.5
1.010
6.9
S.D.
10.88
.0047
.22
o N 5 55
o
c-
r,
00 &
Table 29
Summary of Clinical Urinalysis Data
Females
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U VOL ML
SP GR
U PH
Covance 6329-212 3M T-6316.1
0
MEAN
19.9
1.012
S.D.
17.75
.0102
N 55
6.8 .27 5
300
o
MEAN S.D.
21.6 12.63
1.010 .0051
6.7 .45
C N 555
C4
to
CO
Tabla 30
Summary of Clinical Urinalysis Data
Males
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U VOL ML
SP GR
U PH
Covance 6329-212 3M T-6316.1
0 MEAN S.D. N
18.7 14.79
10
1.024 .0151 10
6.9 .39 10
3
MEAN
25.1
1.015
6.9
S.D.
15.47
.0079
.21
oo N 10 10 10 30
MEAN
15.8
1.022
6.8
S.D.
9.53
.0109
.26
N 10 10 10
GO 100
MEAN
19.9
1.022
6.8
S.D.
15.56
.0160
.35
N 10 10 10
Table 30
Summary of Clinical Urinalysis Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U VOL ML
SP GR
U PH
Covance 6329-212 3M T-6316.1
0 MEAN S.D. N
19.0 13.21
10
1.012
.0082 10
6.7 .26 10
3
MEAN
22.2
1.012
S.D.
16.26
.0102
N 10 10
6.8 ,26 10
6 30
Cu
MEAN
19.2
1.014
6.6
S.D.
16.50
.0109
.39
N 10 10 10 G3
100
MEAN S.D. N
23.2 16.13
10
1.012 .0086 10
6.6 .16 10
Table 31
Summary of Clinical Urinalysis Data
Males
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U VOL ML
SP GR
U PH
Covance 6329-228 3M T-6316.1
0
MEAN
22.7
1.015
S.D.
15.31
.0116
N 10 10
7.1 .32 10
1
MEAN
21.9
1.017
7.2
6 S.D. N
13.22 10
.0085 10
.24 10
e-
GO
G5
Table 31
Summary of Clinical Urinalysis Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE PPm
U VOL ML
SP GR
U PH
Covance 6329-228 3M T-6316.1
0
MEAN
12.5
1.017
S.D.
13.88
.0078
N 10 10
6.8 .26 10
1
MEAN
22.0
1.012
S.D.
18.74
.0112
N 10 10
6.7 .26 10
c.
GO CD
Table 32
Summary of Clinical Urinalysis Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U VOL ML
SP GR
U PH
Covance 6329-212 3M T6316.1
0
MEAN
15.5
1.024
S.D.
8.17
.0087
N 10 10
7.0 .33 10
3
MEAN
13.7
1.025
S.D.
5.65
.0090
N 10 10
7.2 .35 10
30 MEAN S.D. N
13.7 13.33
10
1.030 .0137 10
7.0 .33 10
o 100
MEAN
15.4
1.025
7.0
C-j
S.D. N
13.36 10
.0100 10
.33 10
o
e
o
c** u CO
Table 32
Summary of Clinical Urinalysis Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
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
18.1 16.96
10
15.9 15.38
10
13.0 13.35
10
13.2 8.01 10
1.019 .0140 10
1.016 .0100 10
1.020 .0190 10
1.019 .0081 10
6.9 .32 10
6.8 .41 10
6.7 .35 10
6.8 .49 10
Covance 6329-212 3M T6316.1
Table 33
Summary of Clinical Urinalysis Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U VOL ML
SP GR
U PH
0 MEAN S.D.
N
13.8 12.00
10
1.022 .0081 10
1
MEAN
15.4
1.026
S.D.
13.27
.0125
N 10 10
6.9 .39 10
7.0 .28 10
Covance 6329-228 3M T6316.1
Table 33
Summary of Clinical Urinalysis Data
Females
Meek 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U VOL ML
SP GR
U PH
Covance 6329-228 3M T6316.1
0
MEAN
17.1
1.019
S.D.
17.79
.0134
N 10 10
1 MEAN S.D. N
20.0 17.04
10
1.018 .0126 10
6.6 .21 10
6.6 .16 10
O O
C4
CD
CO
O
w
pV-. j1 IQ w
Table 34
Summary o Clinical Urinalysis Data
Hales
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
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
19.3 15.90
10
13.7 6.72 10
14.7 7.46 10
17.3 12.78
10
1.024 .0092 10
1.029 .0106 10
1.026 .0078 10
1.023 .0110 10
6.8 .26 10
7.0 .33 10
6.8 .35 10
6.8 .34 10
Covance S329-212 3M T6316.1
Table 34
Summary of Clinical Urinalysis Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
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
13.1 7.81 10
19.3 17.82
10
13.7 12.84
10
17.0 14.38
10
1.018 .0074 10
1.018 .0122 10
1.021 .0101 10
1.021 .0131 10
6.4 .28 10
6.4 .16 10
6.4 .24 10
6.4 .16 10
Covance 6329-212 3M T6316.1
Table 35
Summary of Clinical Urinalysis Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1*) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U VOL ML
SP GR
U PH
0 MEAN S.D. N
1 MEAN S.D. N
14.7 12.83
10
1.026 .0110 10
10.5 6.47 10
1.030 .0123 10
7.0 .33 10
6.9 .21 10
Covance 6329-228 3M T6316.1
oo
c ,i
N w
Table 35
Summary of Clinical Urinalysis Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U VOL ML
SP GR
U PH
0 MEAN S.D. N
1 MEAN S.D. N
27.2 19.88
10
13.0 10.19
10
1.014 .0106 10
1.019 .0093 10
6.5 .24 10
6.5 .33 10
Covance 6329-228 3M T6316.1
<*>
w
Table 36
summary of Urine Chemistry Data
Males
Week 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
300 MEAN S.D. N
27 13.5
5
20 14.2
5
120 36.4 5
41 * 18.8
5
.37 .135
5
.53 .213
4
1.99 1.394
5
1.10 .403 4
Covance 6329-212 3M T-6316.1
rs O C-s
fg
06
Table 36
Summary of Urine Chemistry Data
Females
Meek 8
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
300 MEAN S.D. N
16 11.4
5
20 9.9 5
53 47.3
5
42 18.0
5
.15 .074
4
.38 .178
4
.46 .164
4
.76 * .113
4
Covance 6329-212 3M T-6316.1
oo
CO CD
C03300
Table 37
Summary of Urine Chemistry Data
Males
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
28 15.9 10
22 14.5 10
30 24.4 10
29 28.2 10
155 111.3
10
82 51.3 10
127 88.4 10
128 115.5
10
.35 .159 10
.40 .197 10
.32 .108 10
.31 .071 10
1.70 .469 10
1.40 .521 10
1.44 .405 10
1.35 .335 10
Covance 6329-212 3H T-6316.1
tocroo
Table 37
Summary of Urine Chemistry Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
MEAN S.D. N
MEAN S.D. N
MEAN S.D. N
19 12.0 10
21 16.5 10
18 11.0 10
20 15.4 10
61 47.7 10
70 73.0 10
73 76.5 10
57 51.3 10
.25 .062 10
.26 .139 10
.22 .132 10
.31 .098 10
.74 .256 10
.66 .214 10
.65 .244 10
.72 .271 10
Covance 6329-212 3M T-6316.1
Table 38
summary o Urine Chemistry Data
Hales
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
MEAN S.D. N
24 16.7 10
30 14.3 10
80 72.9 10
89 43.9 10
.35 .079
9
.51 * .151
9
1.06 .227 9
1.53 * .425 9
Covance 6329-228 3M T-6316.1
<" >
C
Co
o
iO
corroo
Table 38
Summary of Urine Chemistry Data
Females
Week 14
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
1 MEAN S.D. N
26 12.0 10
18 12.0 10
76 34.6 10
51 41.3 10
.22 .119
9
.22 .126
8
.64 .273
9
.56 .333
8
Covance 6329-228 3M T-6316.1
Table 39
Summary of Urine Chemistry Data
Hales
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
Covance 6329-212 3M T6316.1
MEAN S.D. N
28 15.9 10
102 47.8 10
.37 .227
10
1.30 .281 10
MEAN S.D. N
34 11.2 10
102 34.0 10
.46 .227 10
1.26 .274 10
30 MEAN S.D. N
46 20.5 10
135 76.2 10
.43 .197 10
1.12 .266 10
100
MEAN 43 114 .46 1.26
S.D.
25.3
56.2
.186
.413
oo N 10 10 9 9
Co
Co
o
c,'.
4
o
t/1
Table 39
Summary of Urine Chemistry Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%| N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
23 16.1 10
29 22.9 10
21 10.7
9
27 20.8 10
85 58.0 10
66 43.7 10
52 20.2
9
78 38.4 10
.24 .164
8
.26 .148
9
.24 .133
8
.27 .098 10
.81 .318
8
.61 .173
9
.57 .229
8
.81 .191 10
Covance 6329-212 3M T6316.1
oo
u
o
m
Table 40
Summary of Urine Chemistry Data
Males
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
MEAN S.D. N
MEAN S.D. N
18 9.3
10
26 18.7 10
112 52.8 10
151 123.3
10
.18 .062 10
.24 .135
9
1.11 .383 10
1.34 .363 9
Covance 6329-228 3M T6316.1
Table 40
Summary of Urine Chemistry Data
Females
Week 27
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
1 MEAN S.D. N
16 16.3 10
10 7.1 9
101 83.6 10
70 47.4
9
.08 .025
8
.14 * .057
9
.61 .212
8
.96 * .383
9
Covance 6329-228 3M T6316.1
oo
c-
uo
Table 41
Summary of Urine Chemistry Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
Covance 6329-212 3M T6316.1
0 MEAN S.D. N
3 MEAN S.D. N
30 MEAN S.D. N
100 MEAN S.D. N
23 9.5
10
27 7.2
10
28 11.2 10
28 12.5 10
110 52.5 10
141 60.8 10
136 61.5 10
116 58.9 10
.28 .077
8
.33 .102 10
.39 .221 10
.38 .142
9
1.50 .296 8
1.62 .273 10
1.63 .462 10
1.45 .335 9
Co
oC O
OS
<r> o
C-1.
cCs>
Table 41
Summary of Urine Chemistry Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
UK MMOL/L
NA EXC MMOL
K EXC MMOL
0
3 30 100
MEAN S.D. N
MEAN S.D. N
MEAN S.D. N
MEAN S.D. N
29 16.8 10
29 23.4 10
24 12.6 10
31 27.4 10
88 40.9 10
92 68.9 10
101 60.4 10
113 82.0 10
.33 .206
10
.26 .086
8
.24 .107
9
.28 .107
10
.91 .240
10
.87 .283
8
.98 .395
9
1.01 .329 10
Covance 6329-212 3M T6316.1
Table 42
Summary of Urine Chemistry Data
Males
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
1 MEAN S.D. N
20 13.0 10
26 17.9 10
143 68.2 10
165 88.6 10
.23 .135
9
.20 .100
10
1.61 .579 9
1.29 .256 10
Covance 6329-228 3M T6316.1
O
Co
ti
H*
O
Table 42
Summary of Urine Chemistry Data
Females
Week 53
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) M-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
DOSE ppm
U NA MMOL/L
U K NA EXC
MMOL/L
MMOL
K EXC MMOL
0 MEAN S.D. N
1 MEAN S.D. N
13 9.6
10
20 14.9 10
64 48.6 10
118 101.1
10
.25 .191
6
.18 .085 10
.93 .569
6
.93 .290 10
Covance 6329-228 3M T6316.1
O
. C` Q H*
TABLE 43 Summary of Organ Height Data
Week 4 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 1
TABLE INCLUDES: SEX=ALL;GR0UP=1,2,3,4,5;WEEKS=ALL DEATH=1 ;SUBSET=T
LIVER
SEX DOSE GROUP
M1
NUMBER IN GROUP; MEAN:
STANDARD DEV:
M2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
<g)
ORGAN WEIGHT
(g)
5 350.7
33.3
5 10.8223
1.5753
5 362.8
32.5
5 10.7856
1.1739
ORGAN-TOBODY WT (%)
5 3.0744 0.1520
ORGAN-TO-
BRAIN WT RATIO
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 2.9699 0.1104
F2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 196.1
20.3
5 209.0
29.8
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TO-
BRAIN WT RATIO
5 6.4594 0.4155
5 3.3170 0.3676
5 6.7264 0.7320
5 3.2329 0.1459
M3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 344.4
28.5
5 10.9453
1.5396
5 3.1683 0.2257
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 198.8
17.2
5 6.8324 0.6354
5 3.4373 0.1362
TABLE 43 Summary of Organ Weight Data
Week 4 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 2
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4,5;WEEKS=ALL DEATH=1 ;SUBSET=T
LIVER
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
M5
NUMBER IN GROUP MEAN
STANDARD DEV
5 343.8
36.4
5 12.2371
0.9341
5 3.5708 0.2090
5 310.0
28.3
5 15.7639
1.4058
5 5.0860 0.1240
NUMBER IN GROUP: MEAN:
STANDARD DEV:
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 191.3
13.1
5 7.1709 0.5706
5 181.6
15.1
5 9.2338 1.4896
5 3.7577 0.3444
5 5.1048 0.8198
TABLE 44 Summary of Organ Weight Data
Week 4 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 1
TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=1;SUBSET=T
LIVER
SEX DOSE GROUP
M8
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
5 314.0
18.3
5 11.5023
1.4141
ORGAN-TOBODY WT (%)
5 3.6573 0.3062
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
<g)
5 199.2 14.9
ORGAN
WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
75.7008 0.9577
35.8600 0.2780
M9
NUMBER IN GROUP MEAN
STANDARD DEV
5 308.7
14.1
5 11.1683
0.9088
5 3.6223 0.3092
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 218.0
20.1
5 8.1095 1.1330
5 3.7211 0.3797
6
Co
to
TABLE 45 Summary of Organ Weight Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE {98.1%) N-ETHYL PERFLUOROOCTANBSULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 1
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2;SUBSET=ALL
LEFT ADRENAL
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
H1
F1
NUMBER IN GROUP MEAN
STANDARD DEV
5 442.3
31.8
5 0.0318 0.0042
5 0.0072 0.0013
5 0.0146 0.0020
NUMBER IN GROUP MEAN
STANDARD DEV
5 257.4
31.4
5 0.0400 0.0077
5 0.0155 0.0018
5 0.0198 0.0036
O M5
F5
NUMBER IN GROUP
55
5
5 NUMBER IN GROUP 5 5
5
5
MEAN
317.3* 0.0278
0.0088
0.0136
MEAN
170.3* 0.0304*
0.0179
0.0167
Mi
STANDARD DEV
50.6
0.0056
0.0018
0.0029
STANDARD DEV
14.1
0.0043
0.0021
0.0023
o o
C.-j
Co
to
TABLE 45 Summary of Organ Weight Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 2
TABLE INCLUDES: SEX=ALL;GR0UP=1,5;WEEKS=ALL DEATH=2;SUBSET=ALL
RIGHT ADRENAL
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 442.3
31.8
ORGAN WEIGHT
(g)
5 0.0295 0.0029
ORGAN-TOBODY WT (%)
5 0.0067 0.0011
ORGAN-TOBRAIN WT
RATIO
5 0.0136 0.0014
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY. WT
(9)
5 257.4
31.4
ORGAN WEIGHT
(g)
5 0.0373 0.0060
ORGAN-TOBODY WT (%)
ORGAN-TO BRAIN WT
RATIO
5 0.0145 0.0014
5 0.0184 0.0029
M5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 317.3*
50.6
5 0.0261 0.0064
5 0.0082 0.0013
5 0.0126 0.0024
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 170.3*
14.1
5 0.0283 0.0078
5 0.0166 0.0043
5 0.0156 0.0045
TABLE 45 Summary of Organ Height Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3H T-6316.1
PAGE: 3
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2;SUBSET=ALL
BRAIN
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
M1
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 442.3
31.8
5 2.1728 0.0240
5 0.4934
0.0382
5 1.0000 0.0000
NUMBER IN GROUP MEAN
STANDARD DEV
5 257.4
31.4
5 2.0222 0.0981
5 0.7919 0.0687
5 1.0000
0.0000
o
o M5
c . NUMBER IN GROUP: C v MEAN:
STANDARD DEV:
5 317.3*
50.6
5 2.0479 0.1770
5 0.6519* 0.0594
5 1.0000 0.0000
F5
NUMBER IN GROUP MEAN
STANDARD DEV
5 170.3*
14.1
5 1.8176* 0.1064
5 1.0704* 0.0662
5 1.0000 0.0000
<1
TABLE 45 Summary of Organ Height Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 4
TABLE INCLUDES: SEX=ALL;GROUPS1,5;WEEKSsALL DEATH=2;SUBSET=ALL
LEFT KIDNEY
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(?)
5 442.3
31.8
ORGAN WEIGHT
(?)
5 1.4309 0.1350
ORGAN-TOBODY WT (%)
5 0.3240 0.0269
ORGAN-TOBRAIN WT
RATIO
5 0.6586 0.0623
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(?)
5 257.4
31.4
ORGAN WEIGHT
(?)
5 0.9220 0.1189
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
5 0.3585 0.0268
5 0.4550 0.0456
H5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 317.3*
50.6
5 1.4077 0.2404
5 0.4435* 0.0220
5 0.6856 0.0805
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 170.3*
14.1
5 0.7874* 0.0384
5 0.4640*
0.0309
5 0.4338 0.0216
TABLE 45 Summary of Organ Weight Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 5
TABLE INCLUDES: SEX=ALL:GROUP=l,5;WEEKS=ALL DEATH=2;SUBSET=ALL
RIGHT KIDNEY
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
5 442.3
31.8
ORGAN WEIGHT
(0)
5 1.4168 0.1080
ORGAN-TOBODY WT (%)
5 0.3207 0.0177
ORGAN-TOBRAIN WT
RATIO
5 0.6520 0.0489
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
5 257.4
31.4
ORGAN WEIGHT
(0)
5 0.9348 0.1123
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 0.3637 0.0252
5 0.4616 0.0441
GTrroo
M5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 317.3*
50.6
5 1.4785 0.2950
5 0.4640* 0.0242
5 0.7191 0.1033
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 170.3*
14.1
5 0.7994* 0.0471
5 0.4710* 0.0323
5 0.4400 0.0132
TABLE 45 Summary of Organ Height Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PEHFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 6
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WBEKS=ALL DEATH=2;SUBSET=ALL
LIVER
SEX DOSE GROUP
H1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(9)
5 442.3
31.8
5 11.4244
1.6279
ORGAN-TOBODY WT (%)
5 2.5734 0.2217
ORGAN-TOBRAIN WT
RATIO
5 5.2578 0.7478
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 257.4
31.4
5 7.2921 0.7864
5 2.8388 0.1198
5 3.6049 0.3306
6 M5
F5
NUMBER IN GROUP:
55
5
5
NUMBER IN GROUP:
55
5
5
Z>i
MEAN:
317.3* 21.6104*
6.8321* 10.5688*
MEAN:
170.3* 11.7394*
6.9106*
6.4698*
oN
STANDARD DEV:
50.6
3.4376
0.5778
1.4711
STANDARD DEV:
14.1
0.7410
0.3939
0.4478
TABLE 45 Summary of Organ Weight Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 7
TABLE INCLUDBS:
SEX=ALL ;GROUP=1,5;WEEKS=ALL
DEATH=2;SUBSET=ALL
LUNG
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 442.3
31.8
ORGAN WEIGHT
(g)
5 1.4802 0.1217
ORGAN-TOBODY WT (%)
5 0.3350 0.0213
ORGAN-TOBRAIN WT
RATIO
5 0.6809 0.0501
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 257.4
31.4
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TO BRAIN WT
RATIO
5 1.2546 0.1756
5 0.4874 0.0348
5 0.6195 0.0726
M5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 317.3*
50.6
5 1.2530 0.2690
5 0.3928* 0.0306
5 0.6091 0.0971
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 170.3*
14.1
5 0.8541*
0.0609
5 0.5028 0.0340
5 0.4704 0.0313
COo
H*
TABLE 45 Summary of Organ Weight Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance G329-212 3M T-6316.1
PAGE: 8
TABLE INCLUDES: SEX=ALL ;GROUP=l,5;WEEKS=ALL DEATH=2 ;SUBSET=ALL
LEFT OVARY
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT ()
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
M1
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
oO M5
`i
Co
NUMBER IN GROUP: MEAN:
t o STANDARD DEV:
to
5 442.3
31.8
5 317.3*
50. G
NUMBER IN GROUP: MEAN:
STANDARD DEV:
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 257.4
31.4
5 0.0663 0.0160
5 0.0255 0.0043
5 170.3*
14.1
5 0.0468* 0.0078
5 0.0276 0.0048
5 0.0326 0.0070
5 0.0258 0.0048
TABLE 45 Summary of Organ Height Data
Heek 8 Sacrifice
104-HEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 9
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2;SUBSET=ALL
RIGHT OVARY
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY HT
(g)
5 442.3
31.8
ORGAN WEIGHT
(g)
ORGAN-TOBODY HT {)
ORGAN-TOBRAIN HT
RATIO
SEX DOSE GROUP
F1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(3)
ORGAN WEIGHT
(3)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 257.4
31.4
5 0.0733 0.0184
5 0.0282 0.0044
5 0.0361 0.0081
co
M5
CJ
M
NUMBER IN GROUP: MEAN:
S 317.3*
STANDARD DEV:
50.6
F5
NUMBER IN GROUP MEAN
STANDARD DEV
5 170.3*
14.1
5 0.0527 0.0085
5 0.0311 0.0050
5 0.0291 0.0052
TABLE 45 Summary of O r g a n Height Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 10
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WBEKS=ALL DEATH=2 ;SUBSET=ALL
SPLEEN
CO
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
<g>
5 442.3
31.8
ORGAN WEIGHT
(g)
5 0.7326 0.1440
ORGAN-TOBODY WT (%)
5 0.1646 0.0248
ORGAN-TOBRAIN WT
RATIO
5 0.3372 0.0666
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 257.4
31.4
ORGAN WEIGHT
(g)
5 0.4972 0.0520
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 0.1942 0.0188
5 0.2454 0.0142
Co M 5
roW NUMBER IN GROUP: MEAN: STANDARD DEV:
5 317.3*
50.6
5 0.5901 0.1298
5
0.1852 0.0199
5 0.2869 0.0482
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 170.3*
14.1
5 0.3599* 0.0407
5 0.2127 0.0312
5 0.1981' 0.0193
TABLE 45 Summary of Organ Weight Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANBSULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3H T-6316.1
PAGE: 11
TABLE INCLUDES: SEX=ALL;GROUP=1,5;WEEKS=ALL DEATH=2;SUBSET=ALL
LEFT TESTIS
SEX DOSE GROUP
TERMINAL BODY WT
(?)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
M1
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 442.3
31.8
5 1.4941 0.1390
5 0.3378 0.0185
5 0.6875 0.0615
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 257.4
31.4
N5
F5
C-* NUMBER IN GROUP: 5 5
5
5
NUMBER IN GROUP:
5
Cj
MEAN:
317.3* 1.7529*
0.5580*
0.8581*
MEAN:
170.3*
STANDARD DEV:
50.6
0.1520
0.0501
0.0633
STANDARD DEV:
14.1
ro
TABLE 45 Summary of Organ Weight Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 12
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2;SUBSET=ALL
RIGHT TESTIS
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 442.3
31.8
ORGAN WEIGHT
(g)
5 1.5159 0.1642
ORGAN-TOBODY WT (%)
5 0.3424 0.0221
ORGAN-TOBRAIN WT
RATIO
5 0.6976 0.0746
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 257.4
31.4
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TO BRAIN WT
RATIO
M5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 317.3*
50.6
5 1.7399 0.1642
5 0.5535* 0.0492
5 0.8511* 0.0601
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 170.3*
14.1
TABLE 45 Summary of Organ Weight Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 13
TABLE INCLUDES: SEX=ALL; GROUP=l,5;WEEKS=ALL
DEATH=2;SUBSET=ALL
LEFT THYROID/PAR
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TO-
BRAIN WT RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TO BRAIN WT
RATIO
H1
F1
in 1
X
NUMBER IN GROUP MEAN
o STANDARD DEV
o
C-> C v NUMBER IN GROUP r o MEAN
STANDARD DEV
5 442.3
31.8
4 0.0128 0.0026
4 0.0028 0.0006
5 317.3*
50.6
4 0.0093 0.0015
4 0.0031 0.0009
4 0.0059
0.0012
NUMBER IN GROUP: MEAN:
STANDARD DEV:
4 0.0047 0.0012
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 257.4
31.4
5 0.0083
0.0021
5 0.0032 0.0007
5 0.0041 0.0010
5 170.3*
14.1
4 0.0076 0.0022
4 0.0043 0.0013
4 0.0041 0.0013
TABLE 45 Summary of Organ Height Data
Week 8 sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 14
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2;SUBSET=ALL
RIGHT THYROID/PR
SEX DOSE GROUP
TERMINAL BODY WT
(g>
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(g>
ORGAN WEIGHT
tg>
ORGAN-TOBODY WT (%>
ORGAN-TO BRAIN WT
RATIO
M1
F1
NUMBER IN GROUP: o MEAN:
STANDARD DEV: o
e-
CO M 5
w NUMBER IN GROUP: G3 MEAN:
STANDARD DEV:
5 442.3
31.8
5 0.0113 0.0049
5 317.3*
50.6
5 0.0102 0.0033
5 0.0025 0.0010
5 0.0032 0.0009
5 0.0052 0.0022
5 0.0050 0.0015
NUMBER IN GROUP: MEAN:
STANDARD DEV:
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 257.4
31.4
5 0.0074 0.0022
5 170.3*
14.1
5 0.0078 0.0024
5 0.0029 0.0008
5 0.0046 0.0016
5 0.0037 0.0011
5 0.0043 0.0014
TABLE 45 Summary of Organ Weight Data
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 15
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL
DEATH=2;SUBSET=ALL
UTERUS
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 442.3
31.8
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(?)
5 257.4
31.4
ORGAN WEIGHT
(9)
5 0.5992 0.1269
ORGAN-TOBODY WT <%)
ORGAN-TOBRAIN WT
RATIO
5 0.2334 0.0468
5 0.2958 0.0584
M5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 317.3*
50.6
F5
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 170.3*
14.1
5 0.4823 0.1903
5 0.2821 0.1076
5 0.2633 0.0945
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 1
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT ADRENAL
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(ff)
5 535.9
54.5
ORGAN WEIGHT
(9)
5 0.0373 0.0080
ORGAN-TOBODY WT (%)
5 0.0069 0.0008
ORGAN-TOBRAIN WT
RATIO
5 0.0168 0.0035
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(ff)
5 291.3
46.9
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 0.0336 0.0052
5 0.0119 0.0032
5 0.0169 0.0030
n
to
M2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 531.5
24.6
5 0.0277 0.0061
5 0.0052 0.0013
5 0.0127 0.0031
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 255.2
30.7
5 0.0360 0.0055
5 0.0142 0.0024
5 0.0185 0.0025
M3
NUMBER IN GROUP MEAN
STANDARD DEV
5 539.3
70.5
5 0.0295 0.0022
5 0.0055 0.0007
5 0.0129 0.0010
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 264.2
31.1
5 0.0369 0.0077
5 0.0141 0.0030
5 0.0186 0.0035
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 2
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT ADRENAL
SEX DOSE GROUP
M4
TERMINAL BODY wr
(?)
ORGAN WEIGHT
<g>
ORGAN-TOBODY WT (%)
ORGAN-TO-
BRAIN WT RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
<g>
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TO-
BRAIN WT RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
5 0.0303 0.0034
5 0.0065 0.0011
5 0.0139 0.0019
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
5 0.0322
0.0049
5 0.0137 0.0027
5 0.0173 0.0036
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-BTHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 3
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WBBKS-ALL DEATH=3 ;SUBSET=ALL
RIGHT ADRENAL
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
M1
F1
NUMBER IN GROUP:
55
5
5 NUMBER IN GROUP
o
MEAN:
535.9
0.0353
0.0065
0.0159
MEAN
o
STANDARD DEV:
54.5
0.0076
0.0009
0.0033
STANDARD DEV
CJ
CO M 2
F2
C J NUMBER IN GROUP:
55
5
5 NUMBER IN GROUP
to
MEAN:
531.5
0.0256*
0.0048*
0.0118
MEAN
STANDARD DEV:
24.6
0.0043
0.0009
0.0023
STANDARD DEV
5 291.3
46.9
5 0.0337 0.0071
5 0.0119 0.0034
5 0.0171 0.0042
5 255.2
30.7
5 0.0336 0.0052
5 0.0132 0.0016
5 0.0173 0.0024
M3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 539.3
70.5
5 0.0273 0.0034
5 0.0051* 0.0004
5 0.0119 0.0012
F3
NUMBER IN GROUP MEAN
STANDARD DEV
5 264.2
31.1
5 0.0345 0.0059
5 0.0131
0.0019
5 0.0174 0.0025
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 4
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT ADRENAL
SEX DOSE GROUP
M4
TERMINAL BODY WT
(g)
ORGAN WEIGHT
<ff>
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
rrcroo
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
S 0.0286 0.0030
5 0.0061 0.0009
5 0.0131 0.0018
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
5 0.0307
0.0036
5 0.0131 0.0023
5 0.0165
0.0028
TABLE 46 Summary of Organ Waight Data
Week 14 sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 5
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
BRAIN
SEX DOSE GROUP
TERMINAL
(a)BODY WT
ORGAN
<g)WEIGHT
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL
(g)BODY WT
ORGAN
<g)WEIGHT
ORGAN-TOBODY WT
(%)
ORGAN-TO BRAIN WT
RATIO
M1
F1
NUMBER IN GROUP:
55
5
5
NUMBER IN GROUP:
55
5
5
o
MEAN:
535.9
2.2215
0.4182
1.0000
MEAN:
291.3
1.9905
0.6962
1.0000
o
STANDARD DEV:
54.5
0.0445
0.0452
0.0000
STANDARD DEV:
46.9
0.0791
0.1058
0.0000
Co
M2
F2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 531.5
24.6
5 2.1920 0.0960
5 0.4126 0.0123
5 1.0000
0.0000
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 255.2
30.7
5 1.9423 0.1026
5 0.7665
0.0587
5 1.0000 0.0000
334
M3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 539.3
70.5
5
2.2818 0.1054
5
0.4273 0.0430
5 1.0000 0.0000
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 264.2
31.1
5 1.9846 0.1121
5 0.7566 0.0628
5 1.0000 0.0000
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-BTHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 6
TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
BRAIN
SEX DOSE GROUP
M4
TERMINAL BODY WT
(g)
ORGAN WEIGHT
la)
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:
55
5
5 NUMBER IN GROUP: 5 5
5
5
MEAN:
473.3
2.1861
0.4642
1.0000
MEAN:
236.9
1.8793
0.7961
1.0000
STANDARD DEV:
39.1
0.0723
0.0397
0.0000
STANDARD DEV:
21.2
0.1322
0.0609
0.0000
e-3
co
CO
cn
co cCoo
CO
&
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WIT NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 7
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT KIDNEY
SEX DOSE GROUP
M1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
5 535.9
54.5
5 1.9711 0.1974
ORGAN-TOBODY WT (%)
5 0.3686 0.0233
ORGAN-TOBRAIN WT
RATIO
5 0.8874 0.0880
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
<g>
5 291.3
46.9
ORGAN WEIGHT
(g)
5 1.1328 0.1492
ORGAN-TOBODY WT (%)
ORGAN-TO BRAIN WT
RATIO
5 0.3911 0.0283
5 0.5688 0.0667
M2
NUMBER IN GROUP MEAN
STANDARD DEV
5 531.5
24.6
5 1.8955 0.1575
5 0.3570 0.0307
5 0.8661 0.0818
F2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 255.2
30.7
5 0.9311 0.1262
5 0.3658 0.0386
5 0.4782 0.0473
M3
NUMBER IN GROUP MEAN
STANDARD DEV
5 539.3
70.5
5 2.0805 0.2924
5 0.3863 0.0302
5 0.9111 0.1154
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 264.2
31.1
5 1.1345 0.1316
5 0.4307 0.0362
5 0.5718 0.0615
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3H T-6316.1
PAGE: 8
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4:WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT KIDNEY
SEX DOSE GROUP
M4
TERMINAL BODY WT
(?)
ORGAN WEIGHT
(?)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(?)
ORGAN WEIGHT
(?)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
5 2.1488 0.2660
5 0.4535* 0.0313
5 0.9817 0.1017
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
5 0.9648 0.1536
5 0.4053 0.0302
5 0.5124 0.0648
oo
Cj
CO co
QO
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1*) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 9
TABLE INCLUDES: SEX=ALL;GR0UP=1, 2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT KIDNEY
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 535.9
54.5
ORGAN WEIGHT
(g>
5 2.0585 0.2090
ORGAN-TOBODY WT (%)
5 0.3846 0.0203
ORGAN-TOBRAIN WT
RATIO
5 0.9265 0.0904
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 291.3
46.9
ORGAN WEIGHT
(g)
5 1.1236 0.1700
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 0.3874 0.0341
5 0.5644
0.0797
M2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 531.5
24.6
5 1.9405 0.1411
5 0.3656 0.0297
5 0.8873 0.0831
F2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 255.2
30.7
5 0.9328 0.1505
5 0.3652 0.0354
5 0.4787 0.0596
M3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 539.3
70.5
5 2.0643 0.2531
5 0.3835 0.0209
5 0.9041 0.0972
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 264.2
31.1
5 1.1634 0.1471
5 0.4418 0.0451
5 0.5865 0.0712
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 10
TABLE INCLUDES: SEX=ALL;GROUP=l ,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT KIDNEY
SEX DOSE GROUP
H4
TERMINAL BODY WT
<g>
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(a)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
5 2.1724 0.2812
5 0.4581* 0.0303
5 0.9929 0.1136
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
5 0.9912 0.1534
5 0.4166 0.0305
5 0.5264 0.0638
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 11
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LIVER
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT ()
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(a)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
M1
F1
NUMBER IN GROUP:
55
5
5
NUMBER IN GROUP:
55
5
5
MEAN:
535.9
15.9996
2.9783
7.2008
MEAN:
291.3
8.7487
3.0096
4.4018
o
STANDARD DEV:
54.5
2.1505
0.1425
0.9432
STANDARD DEV:
46.9
1.2794
0.1220
0.6612
Cm
Cm M 2
F2
NUMBER IN GROUP: MEAN:
5 531.5
5 15.6102
5 2.9345
5 7.1245
NUMBER IN GROUP: MEAN:
5 255.2
5 7.4501
5 2.9233
5 3.8304
STANDARD DEV:
24.6
1.7249
0.2531
0.7384
STANDARD DEV:
30.7
1.0845
0.2753
0.4607
M3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 539.3
70.5
5 18.0657
1.7387
5 3.3764 0.3717
5 7.9217 0.7535
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 264.2
31.1
5 8.8944 1.3628
5 3.3658 0.3182
5 4.4714 0.5448
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 12
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3 ;SUBSET=ALL
LIVER
SEX DOSE GROUP
M4
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(3)
ORGAN
(a)WEIGHT
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
Tfrrroo
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
5 24.2906*
3.5145
5 5.1173* 0.3964
5 11.1093*
1.5191
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
5 9.7445 1.1880
5 4.1155* 0.3584
5 5.1846 0.5040
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 13
TABLE INCLUDES: SEX=ALL;GR0UP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LUNG
SEX DOSE GROUP
M1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
5 535.9
54.5
ORGAN WEIGHT
(g)
5 1.8736 0.1592
ORGAN-TOBODY WT (%)
5 0.3510 0.0280
ORGAN-TOBRAIN WT
RATIO
5 0.8428 0.0609
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 291.3
46.9
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT ()
ORGAN-TOBRAIN WT
RATIO
5 1.2020 0.1063
5 0.4182 0.0552
5 0.6048 0.0590
M2
NUMBER IN GROUP MEAN
STANDARD DEV
5 531.5
24.6
5 1.7104 0.0972
5 0.3226 0.0267
5 0.7811 0.0493
F2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 255.2
30.7
5 1.1997 0.1562
5 0.4698 0.0101
5 0.6163 0.0571
M3
NUMBER IN GROUP MEAN
STANDARD DEV
5 539.3
70.5
5 1.9907 0.2684
5 0.3701 0.0333
5 0.8707 0.0899
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 264.2
31.1
5 1.1830 0.0601
5 0.4513 0.0396
5 0.5968 0.0305
TABLE 46 Summary of organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 14
TABLE INCLUDES: SEX=ALL;GROUPsl,2,3,4; WEEKS=ALL DEATH=3;SUBSET=ALL
SEX DOSE GROUP
M4
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g>
LUNG
ORGAN-TOBODY WT {%)
ORGAN-TO BRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
<g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TO
BRAIN WT RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
5 1.6290 0.1108
5 0.3467 0.0448
5 0.7450 0.0411
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5
236.9
21.2
5
1.0859
0.0776
5 0.4601 0.0363
5 0.5784 0.0303
c C CO
CO
TABLE 46 Summary of organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 15
TABLE INCLUDES: SEX=ALL;GROUPAI,2,3,4;WEEKS=ALL
DEATH=3 ;SUBSET=ALL
LEFT OVARY
SEX DOSE GROUP
M1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
5 535.9
54.5
ORGAN WEIGHT
(a)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL
(g)BODY WT
ORGAN
(g)WEIGHT
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 291.3
46.9
5 0.0742 0.0125
5 0.0263 0.0072
5 0.0374 0.0067
M2
NUMBER IN GROUP
5
o
MEAN
531.5
6 STANDARD DEV
24.6
r-,
M3
> NUMBER IN GROUP 5
MEAN
539.3
STANDARD DEV
70.5
F2
NUMBER IN GROUP MEAN
STANDARD DEV
F3
NUMBER IN GROUP MEAN
STANDARD DEV
5 255.2
30.7
5 0.0523 0.0097
5 0.0206 0.0034
5 0.0269 0.0043
5 264.2
31.1
5 0.0608 0.0201
5 0.0230 0.0070
5 0.0304 0.0093
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 16
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT OVARY
SEX DOSE GROUP
M4
TERMINAL BODY WT
(ff)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT ()
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0>
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
e Co
Cw
P* cn
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
5 0.0514 0.0017
5 0.0218 0.0016
5 0.0275 0.0022
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 17
TABLE INCLUDES: SEX=ALL ;GROUPAI ,2,3,4; WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT OVARY
SEX DOSE GROUP
M1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
<g>
5 535.9
54.5
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORCAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
5 291.3
46.9
5 0.0596 0.0166
5 0.0208 0.0061
5 0.0301 0.0090
3
M2
NUMBER IN GROUP MEAN
STANDARD DEV
5 531.5
24.6
F2
NUMBER IN GROUP MEAN
STANDARD DEV
5 255.2
30.7
5 0.0518 0.0140
5 0.0201 0.0047
5 0.0264 0.0063
M3
NUMBER IN GROUP MEAN
STANDARD DEV
5 539.3
70.5
F3
NUMBER IN GROUP MEAN
STANDARD DEV
5 264.2
31.1
5 0.0623 0.0128
S 0.0236 0.0040
5 0.0312 0.0054
TABLE 46 Summary of Organ Haight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covanee 6329-212 3M T-6316.1
PAGE: 18
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKSsALL DEATH=3;SUBSET=ALL
RIGHT OVARY
SEX DOSE GROUP
M4
TERMINAL BODY WT
<g>
ORGAN WBIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TO-
BRAIN WT RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
<g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
C
Cv
5 473.3
39.1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
5 0.0541 0.0054
5 0.0229
0.0026
5 0.0289 0.0036
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 19
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4; WEEKS=ALL DEATH=3;SUBSET=ALL
SPLEEN
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 535.9
54.5
ORGAN WEIGHT
(g)
5 0.7252 0.1659
ORGAN-TOBODY WT (%)
5 0.1345 0.0257
ORGAN-TOBRAIN WT
RATIO
5 0.3266 0.0755
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 291.3
46.9
ORGAN WEIGHT
(g)
5 0.4690 0.0560
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 0.1622 0.0152
5 0.2360 0.0293
M2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 531.5
24.6
5 0.8193 0.0229
5 0.1544 0.0079
5 0.3743 0.0186
F2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 255.2
30.7
5 0.4603 0.0829
5 0.1793 0.0145
5 0.2358 0.0329
M3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 539.3
70.5
5 0.7152 0.1209
5 0.1328 0.0166
5 0.3135 0.0524
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 264.2
31.1
5 0.4512 0.0531
5 0.1711 0.0124
5 0.2272 0.0226
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 20
TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
SPLEEN
SEX DOSE GROUP
M4
TERMINAL BODY WT
(a)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TO BRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
5 0.6639 0.0293
5 0.1408 0.0101
5 0.3037 0.0066
NUMBER IN GROUP:
MEAN: STANDARD DEV:
5 236.9
21.2
5 0.4064 0.0722
5 0.1730 0.0356
5 0.2170 0.0408
TABLE 46 Summary of Organ Haight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 21
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT TESTIS
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(G)
5 535.9
54.5
ORGAN WEIGHT
(a)
5 1.6975 0.1684
ORGAN-TOBODY WT (%)
5 0.3204 0.0570
ORGAN-TOBRAIN WT
RATIO
5 0.7645 0.0789
SEX DOSE GROUP
F1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 291.3
46.9
M2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 531.5
24.6
5
1.7368
0.0912
5 0.3270 0.0161
5 0.7924 0.0251
P2
NUMBER IN GROUP MEAN
STANDARD DEV
5 255.2
30.7
ti 3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 539.3
70.5
5 1.6528 0.0711
5 0.3100 0.03 67
5 0.7254 0.0433
F3
NUMBER IN GROUP MEAN
STANDARD DEV
5 264.2
31.1
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covane 6329-212 3H T-6316.1
PAGE: 22
TABLE INCLUDES: SEX-ALL:GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT TESTIS
SEX DOSE GROUP
M4
TERMINAL BODY WT
<S)
ORGAN WEIGHT
<g>
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(g>
ORGAN WEIGHT
Iff)
ORGAN-TOBODY WT 1%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
5 1.7151 0.1400
5 0.3629 0.0209
5 0.7841 0.0500
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 23
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT TESTIS
SEX DOSE GROUP
TERMINAL BODY WT
(9)
ORGAN WEIGHT
tg)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT
<%>
ORGAN-TOBRAIN WT
RATIO
M1
F1
NUMBER IN GROUP MEAN Co STANDARD DEV
Co
in M 2
NUMBER IN GROUP MEAN
STANDARD DEV
5 535.9
54.5
5 1.7042 0.1307
5
531.5 24.6
5 1.7733 0.1140
5 0.3211 0.0473
5 0.3339 0.0204
5 0.7677 0.0648
NUMBER IN GROUP MEAN
STANDARD DEV
5 0.8087 0.0315
F2
NUMBER IN GROUP: MEAN
STANDARD DEV
5 291.3
46.9
5 255.2
30.7
M3
NUMBER IN GROUP MEAN
STANDARD DEV
5 539.3
70.5
5 1.6684 0.0976
5 0.3131 0.0402
5 0.7324 0.0561
F3
NUMBER IN GROUP MEAN
STANDARD DEV
5 264.2
31.1
TABLE 46 Summary of organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 24
TABLE INCLUDES: SEX=ALL;GROUP=l.2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT TESTIS
SEX DOSE GROUP
M4
TERMINAL BODY WT
(a)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT ()
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(a)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 473.3
39.1
5 1.7278 0.1665
5 0.3653 0.0253
5 0.7902 0.0681
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANBSULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 25
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT THYROID/PAR
SEX DOSE GROUP
TERMINAL BODY WT
iff)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
M1
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 53S.9
54.5
5 0.0125 0.0029
5 0.0023 0.0005
5 0.0056 0.0012
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 291.3
46.9
5 0.0105
0.0040
5 0.0036 0.0013
5 0.0053
0.0022
C
c- M 2
F2
Co
NUMBER IN GROUP
55
5
5
NUMBER IN GROUP:
55
5
5
cn
MEAN
531.5
0.0114
0.0021
0.0052
MEAN:
255.2
0.0076
0.0029
0.0039
&
STANDARD DEV
24.6
0.0022
0.0004
0.0010
STANDARD DEV:
30.7
0.0025
0.0007
0.0012
M3
NUMBER IN GROUP MEAN
STANDARD DEV
5 539.3
70.5
5 0.0132 0.0023
5 0.0025 0.0006
5 0.0058
0.0012
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5
264.2 31.1
5 0.0093 0.0025
5 0.0035 0.0008
5 0.0047 0.0012
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT THYROID/PAR
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
(0)
ORGAN WEIGHT
(g)
Covance 6329-212 3M T-6316.1
PAGE: 26
ORGAN-TOBODY WT (%)
ORGAN-TO-
BRAIN WT RATIO
e NUMBER IN GROUP: 5 5
5
5
NUMBER IN GROUP:
55
5
5
r>
MEAN:
473.3
0.0144
0.0031
0.0066
MEAN:
236.9
0.0092
0.0039
0.0049
Co
STANDARD DEV:
39.1
0.0008
0.0003
0.0005
STANDARD DEV:
21.2
0.0017
0.0005
0.0007
C/T
cn
oc*
O
c/i
TABLE 46 Summary of Organ Height Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covanee 6329-212 3M T-6316.1
PAGE: 27
TABLE INCLUDES: SEX=ALL;GR0UP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT THYROID/PR
SEX DOSE GROUP
H1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
<g)
5 535.9
54.5
ORGAN WEIGHT
(g)
5 0.0120 0.0021
ORGAN-TOBODY WT (%)
5 0.0022 0.0003
ORGAN-TOBRAIN WT
RATIO
5 0.0054 0.0009
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 291.3
46.9
ORGAN WEIGHT
(g)
5 0.0080 0.0026
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
5 0.0029 0.0011
5 0.0041
0.0014
H2
NUMBER IN GROUP MEAN
STANDARD DEV
5
531.5 24.6
5 0.0128 0.0041
5 0.0024 0.0008
5 0.0058 0.0017
F2
NUMBER IN GROUP MEAN
STANDARD DEV
5 255.2
30.7
5 0.0093 0.0033
5 0.0037 0.0014
5 0.0048 0.0017
M3
NUMBER IN GROUP MEAN
STANDARD DEV
5 539.3
70.5
5 0.0138 0.0019
5 0.0026 0.0006
5 0.0061 0.0010
F3
NUMBER IN GROUP MEAN
STANDARD DEV
5 264.2
31.1
5 0.0119 0.0042
5 0.0045 0.0013
5 0.0059 0.0019
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3H T-6316.1
PAGE: 28
TABLE INCLUDES: SEX=ALL;GROUP=l ,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT THYROID/PR
SEX DOSE GROUP
H4
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g>
ORGAN-TOBODY WT <%>
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F4
TERMINAL BODY WT
is)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
NUMBER IN GROUP: MEAN:
5 473.3
5 0.0125
5 0.0026
5 0.0057
NUMBER IN GROUP: MEAN:
5 236.9
5 0.0092
5 0.0039
5 0.0048
Cj
STANDARD DEV:
39.1
0.0014
0.0002
0.0006
STANDARD DEV:
21.2
0.0021
0.0009
0.0008
C4
01
-J
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GROUP=l ,2,3,4;WEEKS=ALL DEATH=3 ;SUBSET=ALL
UTERUS
Covance 6329-212 3M T-6316.1
PAGE: 29
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
<g)
ORGAN WEIGHT
(g)
5 535.9
54.5
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
5 291.3
46.9
ORGAN WEIGHT
(0)
5 0.6337 0.1022
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
5 0.2209 0.0448
5 0.3197 0.0613
M2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 531.5
24.6
F2
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 255.2
30.7
5 0.5244 0.0677
5 0.2058 0.0151
5 0.2695 0.0269
M3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 539.3
70.5
F3
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 264.2
31.1
5 0.6754 0.1666
5 0.2547 0.0519
5 0.3404 0.0847
TABLE 46 Summary of Organ Weight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 30
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
UTERUS
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
M4
<>
Co
NUMBER IN GROUP: MEAN:
5 473.3
ti
STANDARD DEV:
39.1
C/T
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 236.9
21.2
5 0.5414 0.0477
5 0.2293 0.0207
5 0.2898 0.0368
TABLE 47 summary of organ Haight Data
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL ;GROUP=8,9; WEEKS=ALL DEATH=2 ;SUBSET=T
LIVER
Covance 6329-228 3M T-6316.1
PAGE: 1
SEX DOSE GROUP
M8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
S 501.8
59.4
5 14.4950
2.0800
ORGAN-TOBODY WT (%)
5 2.8829 0.1069
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
5 270.7
16.9
ORGAN WEIGHT
(0)
5 8.0939 0.4382
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
PATIO
5 3.0001
0.2600
M9
C-
Cw
NUMBER IN GROUP:
54
4
MEAN: STANDARD DEV:
525.2 47.7
16.6952 2.7892
3.1146 0.2426
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 254.9
23.0
5 7.5958
0.1717
5 2.9983 0.2565
TABLE 48 Summary of Organ Height Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 1
TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKSsALL DEATH=4;SUBSET=ALL
LEFT ADRENAL
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN HBIGHT
(0)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
M1
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5
722.2 58.0
5 0.0350 0.0031
5 0.0049 0.0005
5 0.0147 0.0016
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 406.9
32.2
5 0.0445 0.0140
5 0.0112 0.0043
5 0.0202 0.0066
r-
M4
F4
-
NUMBER IN GROUP:
10 10
10
10
NUMBER IN GROUP:
10 10
10
10
w
MEAN:
639.0* 0.0335
0.0053
0.0141
MEAN:
306.3* 0.0375
0.0125
0.0174
STANDARD DEV:
71.5
0.0057
0.0011
0.0025
STANDARD DEV:
49.7
0.0061
0.0030
0.0035
jil
TABLE 48 Summary of Organ Height Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covane 6329-212 3M T-6316.1
PAGE: 2
TABLE INCLUDES: SEX=ALL;GROUP-ALL;WEEKS=ALL DEATH=4 ;SUBSET=ALL
RIGHT ADRENAL
SEX DOSE GROUP
TERMINAL BODY WT
<g>
ORGAN HEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
CO.
M1
F1
Cw NUMBER IN GROUP:
55
5
5
NUMBER IN GROUP:
55
5
5
Cv
MEAN:
722.2
0.0316
0.0044
0.0132
MEAN:
406.9
0.0409
0.0103
0.0185
STANDARD DEV:
58.0
0.0049
0.0006
0.0016
STANDARD DEV:
32.2
0.0146
0.0044
0.0067
to
M4
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 639.0*
71.5
10 0.0324 0.0090
10 0.0052 0.0016
10 0.0137 0.0039
NUMBER IN GROUP:
MEAN: STANDARD DEV:
10 306.3*
49.7
10 0.0347 0.0041
10 0.0117 0.0025
10 0.0161 0.0024
TABLE 48 Summary of Organ Weight Data
Week S3 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 3
TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=4 ;SUBSET=ALL
BRAIN
SEX DOSE GROUP
TERMINAL BODY WT
(g>
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT
(*)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
<g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
O
M1
F1
O
C - NUMBER IN GROUP:
55
5
5
NUMBER IN GROUP:
55
5
5
Co
CO
MEAN: STANDARD DEV:
722.2 58.0
2.3837 0.1629
0.3307 0.0180
1.0000 0.0000
MEAN: STANDARD DEV:
406.9 32.2
2.2100 0.0852
0.5452 0.0395
1.0000 0.0000
CO
M4
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 639.0*
71.5
10 2.3804 0.1067
10 0.3753* 0.0300
10 1.0000 0.0000
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
10 2.1689 0.1318
10 0.7201* 0.0873
10 1.0000 0.0000
TABLE 48 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 4
TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=4;SUBSET=ALL
LEFT KIDNEY
m p ? oo
SEX DOSE GROUP
M1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(0)
5 722.2
58.0
ORGAN WEIGHT
(0)
5 2.3249 0.1910
ORGAN-TOBODY WT (%)
5 0.3224 0.0201
ORGAN-TOBRAIN WT
RATIO
5 0.9749 0.0261
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
5 406.9
32.2
ORGAN WEIGHT
(0)
5 1.3605 0.1412
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 0.3375 0.0587
5 0.6164 0.0694
M4
NUMBER IN GROUP MEAN
STANDARD DEV
10 639.0*
71.5
10 2.4578 0.3355
10 0.3856* 0.0421
10 1.0314 0.1225
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
10 1.4508 0.2497
10 0.4751* 0.0490
10 0.6686 0.1064
TABLE 48 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 5
TABLE INCLUDES: SEX=ALL;GROUP=ALL ;WEEKS=ALL DEATH=4;SUBSET=ALL
RIGHT KIDNEY
SEX DOSE GROUP
TERMINAL
BODY WT
(a)
ORGAN
WEIGHT
(a)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL
BODY WT
(a)
ORGAN
WEIGHT
(a)
ORGAN-TOBODY WT (%)
ORGAN-TO BRAIN WT
RATIO
M1
F1
Co NUMBER IN GROUP
55
5
5
NUMBER IN GROUP:
55
5
5
Cj
MEAN STANDARD DEV
722.2 58.0
2.3397 0.1416
0.3247 0.0166
0.9821 0.0202
MEAN: STANDARD DEV:
406.9 32.2
1.4036 0.1605
0.3486 0.0654
0.6372 0.0898
05
C/ M 4
F4
NUMBER IN GROUP MEAN
STANDARD DEV
10 639.0*
71.5
10 2.4429 0.3646
10 0.3827* 0.0415
10 1.0246 0.1316
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
10 1.5208 0.2577
10 0.4992* 0.0611
10 0.7013 0.1130
TABLE 48 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 6
TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=4 ;SUBSET=ALL
LIVER
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
5 722.2
58.0
5
20.8522 1.6996
ORGAN-TOBODY WT 1%)
5 2.8910 0.1779
ORGAN-TOBRAIN WT
RATIO
5 8.7696 0.8214
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT 1%)
ORGAN-TOBRAIN WT
RATIO
5 406.9
32.2
5 11.1366
0.5964
5 2.7565 0.3325
5 5.0503 0.4241
M4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 639.0*
71.5
10 30.8941*
5.4082
10 4.8476* 0.7573
10 12.9831*
2.2029
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
10 17.2772*
3.6046
10 5.6508* 0.8632
10 7.9473* 1.5028
TABLE 48 Summary of Organ Height Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 7
TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=4;SUBSET=ALL
LUNG
oc
r
u
e>
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
M4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
<g>
ORGAN WEIGHT
<g>
5 722.2
58.0
5 2.1417 0.2399
10 639.0*
71.5
10 2.2129 0.3222
ORGAN-TOBODY WT (%)
5 0.2979 0.0401
ORGAN-TOBRAIN WT
RATIO
5 0.9013 0.1183
SEX DOSE GROUP
F1
NUMBER IN GROUP MEAN
STANDARD DEV
10
0.3472* 0.0412
10 0.9301 0.1290
F4
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT <%)
ORGAN-TO BRAIN WT
RATIO
5 406.9
32.2
5 1.7049 0.1511
5 0.4211 0.0499
5 0.7742 0.0974
10 306.3*
49.7
10 1.6432 0.1425
10 0.5458* 0.0770
10 0.7592 0.0720
TABLE 48 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 8
TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=4;SUBSET=ALL
LEFT OVARY
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
M1
o<r* NUMBER IN GROUP:
5
MEAN:
722.2
STANDARD DEV:
58.0
a
F1
NUMBER IN GROUP MEAN
STANDARD DEV
5 406.9
32.2
5 0.0646 0.0121
5 0.0159 0.0031
5
0.0292 0.0055
GO M 4
NUMBER IN GROUP:
10
MEAN:
639.0*
STANDARD DEV:
71.5
F4
NUMBER IN GROUP MEAN
STANDARD DEV
10 306.3*
49.7
10 0.0731 0.0139
10 0.0245*
0.0062
10 0.0338 0.0067
TABLE 48 Summary of Organ Height Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 9
TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=4;SUBSET=ALL
RIGHT OVARY
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL
BODY WT (g)
ORGAN
WEIGHT (g)
5
722.2 58.0
ORGAN-TO-
BODY WT (%)
ORGAN-TO-
BRAIN WT RATIO
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
5 406.9
32.2
ORGAN WEIGHT
(0)
5 0.0607 0.0097
ORGAN-TOBODY WT ()
ORGAN-TO-
BRAIN WT RATIO
5 0.0150 0.0026
5 0.0275 0.0044
M4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 639.0*
71.5
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
10 0.0781 0.0242
10 0.0262* 0.0096
10 0.0361 0.0114
TABLE 48 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 10
TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=4;SUBSET=ALL
SPLEEN
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
5 722.2
58.0
ORGAN WEIGHT
(g)
5 0.9636 0.1238
ORGAN-TOBODY WT (%)
5 0.1337 0.0168
ORGAN-TOBRAIN WT
RATIO
5 0.4063 0.0660
SEX DOSE GROUP
F1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
5 406.9
32.2
5 0.6205 0.0408
5 0.1531 0.0135
5 0.2808 0.0155
M4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 639.0*
71.5
10 0.9192 0.3274
10 0.1421 0.0398
10 0.3838 0.1251
F4
NUMBER IN GROUP MEAN
STANDARD DEV
10 306.3*
49.7
10 0.5425
0.0914
10 0.1792 0.0311
10 0.2507 0.0442
TABLE 48 Summary of Organ Height Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 11
TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=4;SUBSET=ALL
LEFT TESTIS
SEX DOSE GROUP
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
<g)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT ()
ORGAN-TO BRAIN WT
RATIO
o M1
F1
o
Co NUMBER IN GROUP:
55
5
5
NUMBER IN GROUP:
5
Co
MEAN: STANDARD DEV:
722.2 58.0
1.6043 0.1032
0.2228 0.0164
0.6747 0.0509
MEAN: STANDARD DEV:
406.9 32.2
Vi
N* M 4
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 639.0*
71.5
10 1.7040 0.2865
10 0.2710 0.0609
10 0.7196 0.1362
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
TABLE 48 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANES0LFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 12
TABLE INCLUDES: SEX=ALL ;GROUP-ALL ;WEEKS=ALL DEATH=4;SUBSET=ALL
RIGHT TESTIS
SEX DOSE GROUP
M1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
5 722.2
58.0
ORGAN WEIGHT
(0)
5 1.6110 0.0997
ORGAN-TOBODY WT (%)
5 0.2237 0.0145
ORGAN-TOBRAIN WT
RATIO
'5 0.6772 0.0428
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
5 406.9
32.2
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
H4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 639.0*
71.5
10 1.7805* 0.1392
10 0.2825* 0.0442
10 0.7506 0.0799
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
e
-,
Co
CO
TABLE 48 Summary of organ Height Data
Week S3 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAHIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 13
TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=4;SUBSET=ALL
LEFT THYROID/PAR
SEX DOSE GROUP
H1
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(0)
5 722.2
58.0
ORGAN WEIGHT
(0)
5 0.0151 0.0027
ORGAN-TOBODY WT (%)
5 0.0021 0.0003
ORGAN-TOBRAIN WT
RATIO
5
00..00001613
SEX DOSE GROUP
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
5 406.9
32.2
ORGAN WEIGHT
(0)
5 0.0148 0.0045
ORGAN-TOBODY WT
(%)
ORGAN-TO
BRAIN WT RATIO
5
00..00001317
5 0.0068 0.0022
M4
NUMBER IN GROUP MEAN
STANDARD DEV
10 639.0*
71.5
10 0.0235* 0.0038
10 0.0037* 0.0004
10
0.0099* 0.0015
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
10 0.0156 0.0053
10 0.0052 0.0021
10 0.0072 0.0024
TABLE 48 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 14
TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=4;SUBSET=ALL
RIGHT THYROID/PR
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT ()
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TO-
BRAIN WT RATIO
M1 o
o NUMBER IN GROUP:
MEAN: Co STANDARD DEV:
Cj
5 722.2
58.0
5 0.0189 0.0044
5 0.0026 0.0004
5 0.0079 0.0016
P1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 406.9
32.2
5 0.0167 0.0044
5 0.0041 0.0008
5 0.0076 0.0019
M4
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 639.0*
71.5
10 0.0250 0.0061
10 0.0039* 0.0006
10 0.0105 0.0024
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
10 0.0160 0.0064
10 0.0054 0.0025
10 0.0074 0.0029
TABLE 48 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1*) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 15
TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=4;SUBSET=ALL
UTERUS
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (*)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (*)
ORGAN-TOBRAIN WT
RATIO
V' M 1
C NUMBER IN GROUP:
CJ MEAN:
C i STANDARD DEV:
5 722.2
58.0
F1
NUMBER IN GROUP: MEAN:
STANDARD DEV:
5 406.9
32.2
5 1.1161 0.4939
5 0.2806 0.1321
5 0.5103 0.2406
cn M 4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 639.0*
71.5
F4
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 306.3*
49.7
10 1.1694 0.2972
10 0.3855 0.0989
10 0.5408 0.1387
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 1
TABLE INCLUDES:
SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT ADRENAL
SEX DOSE GROUP
M8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(g)
10 721.2
89.7
10 0.0309 0.0067
ORGAN-TOBODY WT (%)
10 0.0043 0.0007
ORGAN-TOBRAIN WT
RATIO
10 0.0128 0.0026
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
10 412.5
85.7
10 0.0525 0.0225
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
10 0.0133 0.0068
10 0.0244 0.0115
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 0.0334 0.0053
10 0.0046 0.0007
10 0.0140 0.0021
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 396.4
49.5
10 0.0435 0.0075
10 0.0111 0.0022
10 0.0212 0.0030
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 2
TABLE INCLUDES: SEX=ALL;GR0UP=8,9;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT ADRENAL
SEX DOSE GROUP
TERMINAL BODY WT
<g)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (%)
ORGAN-TO-
BRAIN WT RATIO
M8
NUMBER IN GROUP: c- MEAN:
STANDARD DEV: Co
10
721.2 89.7
10 0.0320 0.0046
10 0.0045 0.0006
10 0.0132 0.0016
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10
412.5 85.7
10 0.0384 0.0086
10 0.0096 0.0031
10 0.0177 0.0042
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 0.0286 0.0034
10 0.0040 0.0007
10 0.0120
0.0014
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 396.4
49.5
10 0.0379 0.0072
10 0.0096 0.0019
10 0.0186 0.0036
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANBSULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 3
TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=3;SUBSET=ALL
BRAIN
SEX DOSE GROUP
M8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(a)
ORGAN
(a)WEIGHT
10 721.2
89.7
10 2.4158 0.1977
ORGAN-TOBODY WT (%)
10 0.3385 0.0420
ORGAN-TOBRAIN WT
RATIO
10 1.0000 0.0000
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(a)
ORGAN WEIGHT
(a)
10 4 1 2 .5
8 5 .7
10 2.1708
0.1447
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
10 0.5433
0.0978
10 1.0000 0.0000
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 2.3887 0.0908
10 0.3324 0.0345
10 1.0000 0.0000
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 3 9 6 .4
4 9 .5
10 2.0441* 0.0983
10 0.5221
0.0618
10 1.0000 0.0000
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3H T-6316.1
PAGE: 4
TABLE INCLUDES: SEX-ALL;GROUP=8,9;WEEKS=ALL DEATH=3 ;SUBSET=ALL
LEFT KIDNEY
SEX DOSE GROUP
TERMINAL BODY WT
<g>
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
<g>
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
o N8
F8
y-*
vP
r-
NUMBER IN GROUP:
10 10
10
10
NUMBER IN GROUP:
10 10
10
10
MEAN:
721.2
2.3570
0.3279
0.9754
MEAN:
412.5
1.4112
0.3461
0.6518
C5
STANDARD DEV:
89.7
0.2803
0.0270
0.0820
STANDARD DEV:
85.7
0.2048
0.0284
0.0994
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 2.2022 0.3009
10 0.3056 0.0435
10 0.9215 0.1177
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 396.4
49.5
10 1.3218
0.1769
10 0.3353 0.0394
10 0.6460 0.0730
C03380
TABLE 49 Summary of Organ Height Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT KIDNEY
SEX DOSE GROUP
M8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
<g)
ORGAN HEIGHT
(g)
10 721.2
89.7
10 2.3234 0.2897
ORGAN-TOBODY WT <%)
10 0.3234 0.0315
ORGAN-TOBRAN WT
RATIO
10 0.9622 0.0962
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
10 412.5
85.7
10 1.4370 0.2720
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 2.2647 0.3230
10 0.3144 0.0491
10 0.9474 0.1257
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 396.4
49.5
10 1.3601 0.2061
Covance 6329-228 3M T-6316.1
PAGE: 5
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
10 0.3507 0.0371
10 0.6636 0.1305
10 0.3449 0.0481
10 0.6642 0.0832
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 6
TABLE INCLUDES: SEX=ALL;GROUP=8,9 ;WEEKS=ALL DEATH=3;SUBSET=ALL
LIVER
SEX DOSE GROUP
M8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
ORGAN
WEIGHT
la)
10 721.2
89.7
10 20.2343
4.2122
ORGAN-TOBODY WT ()
10 2.8067 0.4847
ORGAN-TOBRAIN WT
RATIO
10 8.3464 1.4431
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL
BODY WT
la)
ORGAN WEIGHT
(9)
10
412.5 85.7
10 11.3196
2.4524
ORGAN-TOBODY WT <%>
ORGAN-TOBRAIN WT
RATIO
10 2.7467 0.1596
10 5.2305 1.1889
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 20.3650
2.9205
10 2.8120 0.3074
10 8.5202 1.1115
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 396.4
49.5
10 10.9316
1.4863
10 2.7642 0.2431
10 5.3527 0.7110
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 7
TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=3 ;SUBSET=ALL
LUNG
SEX DOSE GROUP
M8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
10 721.2
89.7
10
2.1758 0.2190
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
10
0.3044 0.0381
10 0.9008 0.0625
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
10 412.5
85.7
10 1.6720 0.2500
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
10 0.4216 0.1081
10 0.7736 0.1347
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 2.0380 0.1979
10 0.2845 0.0431
10 0.8542 0.0877
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 396.4
49.5
10 1.4877 0.1285
10 0.3787 0.0404
10 0.7284 0.0599
o
Co
Co
QO
Co
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 8
TABLE INCLUDES: SEX=ALL;CROUP=8,9 ;WEEKS=ALL DEATH=3:SUBSET=ALL
LEFT OVARY
SEX DOSE GROUP
'M 8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
10 721.2
89.7
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F8
NUMBER IN GROUP MEAN
STANDARD DEV
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
10 412.5
85.7
10 0.0564 0.0161
10 0.0143 0.0053
10 0.0263 0.0083
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
F9
NUMBER IN GROUP MEAN
STANDARD DEV
10 396.4
49.5
10 0.0611 0.0183
10 0.0155 0.0047
10 0.0297 0.0081
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329 - 2 2 8 3M T-6316.1
PAGE: 9
TABLE INCLUDES: SEX=ALL:GROUP=8,9;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT OVARY
fr8P?00
SEX DOSE GROUP
M8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
10 721.2
89.7
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(3)
ORGAN WEIGHT
(9)
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
10 412.5
85.7
10 0.0544 0.0176
10 0.0140 0.0059
10 0.0253 0.0090
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10
396.4 49.5
10 0.0624 0.0105
10 0.0160 0.0035
10 0.0305 0.0044
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 10
TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=3;SUBSET=ALL
SPLEEN
SEX DOSE GROUP
M8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(g)
10 721.2
89.7
10
1.0371 0.2467
ORGAN-TOBODY WT (%)
10 0.1430 0.0218
ORGAN-TOBRAIN WT
RATIO
10 0.4265 0.0763
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g>
ORGAN WEIGHT
(g)
10 412.5
85.7
10 0.5884 0.0964
ORGAN-TOBODY WT
(%)
ORGAN-TOBRAIN WT
RATIO
10 0.1446
0.0191
10 0.2721 0.0491
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 1.1631 0.2368
10 0.1618 0.0364
10 0.4862 0.0943
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10
396.4 49.5
10 0.5933 0.1075
10 0.1516 0.0313
10
0.2911 0.0554
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 11
TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=3;SUBSET=ALL
LEFT TESTIS
I- )
Co
Co
05
SEX DOSE GROUP
M8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(9)
ORGAN WEIGHT
(9)
10 721.2
89.7
10
1.8105 0.1543
10 725.1
76.6
10 1.7120 0.3999
ORGAN-TOBODY WT
(%)
ORGAN-TO BRAIN WT
RATIO
10 0.2529 0.0240
10 0.7539 0.0873
10 0.2403 0.0685
10 0.7138 0.1556
VO
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g)
10 412.5
85.7
10 396.4
49.5
ORGAN WEIGHT
(g)
ORGAN-TO- ORGAN-TOBODY WT BRAIN WT (%) RATIO
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 12
TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=3;SUBSET=ALL
RIGHT TESTIS
SEX DOSE GROUP
TERMINAL BODY WT
(0)
ORGAN WEIGHT
(0)
ORGAN-TOBODY WT ()
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
TERMINAL BODY WT
(g)
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT {%)
ORGAN-TOBRAIN WT
RATIO
M8
F8
co NUMBER IN GROUP: MEAN: STANDARD DEV: Cm
CO
00 M 9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 721.2
89.7
10 1.8082 0.1769
10 725.1
76.6
10 1.8413 0.2307
10 0.2523 0.0226
10 0.2571 0.0479
10 0.7S36 0.1006
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 0.7703 0.0872
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 412.5
85.7
10 396.4
49.5
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covane 6329-228 3M T-6316.1
PAGE: 13
TABLE INCLUDES: SEX=ALL;GR0UP=8,9 ;WEEKS=ALL DEATH=3 ;SUBSET=ALL
LF THYROID/PARA
SEX DOSE
TERMINAL BODY WT
ORGAN WEIGHT
ORGAN-TO- ORGAN-TOBODY WT BRAIN WT
SEX DOSE
TERMINAL BODY WT
ORGAN WEIGHT
ORGAN-TO- ORGAN-TOBODY WT BRAIN WT
o GROUP
(g) (g)
(%) RATIO
GROUP
<g) (g)
(%) RATIO
o H8
F8
Co
NUMBER IN GROUP: Ch> MEAN:
10 721.2
10 0.0232
10 0.0032
10 0.0096
NUMBER IN GROUP: MEAN:
10 412.5
10 0.0142
10 0.0035
10 0.0066
00
STANDARD DEV:
89.7
0.0067
0.0007
0.0026
STANDARD DEV:
85.7
0.0032
0.0007
0.0017
GS
M9
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 0.0202 0.0050
10 0.0028 0.0008
10 0.0085 0.0021
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 396.4
49.5
10 0.0177 0.0066
10 0.0045
0.0016
10 0.0087 0.0034
TABLE 49 Summary of Organ Weight Data
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 14
TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=3;SUBSET=ALL
RT THYROID/PARA
TERMINAL
ORGAN ORGAN-TO- ORGAN-TO-
TERMINAL
ORGAN ORGAN-TO- ORGAN-TO-
SEX DOSE
BODY WT
WEIGHT
BODY WT BRAIN WT SEX DOSE
BODY WT
WEIGHT
BODY WT BRAIN WT
GROUP c
(0) (0)
(%) RATIO
GROUP
(0) (0)
(%) RATIO
o M8
F8
c- NUMBER IN GROUP:
10 10
10
10
NUMBER IN GROUP:
10 10
10
10
Cv
MEAN:
721.2
0.0251
0.0035
0.0104
MEAN:
412.5
0.0142
0.0035
0.0066
00
STANDARD DEV:
89.7
0.0079
0.0009
0.0030
STANDARD DEV:
85.7
0.0025
0.0005
0.0013
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
10 0.0242 0.0060
10 0.0034 0.0009
10 0.0101 0.0023
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 396.4
49.5
10 0.0147 0.0044
10 0.0037 0.0010
10 0.0072 0.0020
TABLE 49 Summary of Organ Weight Data
Week S3 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3H T-6316.1
PAGE: 15
TABLE INCLUDES: SEX-ALL;GROUPs8,9;WEEKS=ALL DEATH=3 ;SUBSET=ALL
UTERUS
SEX DOSE GROUP
H8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
<g>
ORGAN WEIGHT
(g)
10 721.2
89.7
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
SEX DOSE GROUP
F8
NUMBER IN GROUP: MEAN:
STANDARD DEV:
TERMINAL BODY WT
(g>
ORGAN WEIGHT
(g)
ORGAN-TOBODY WT (%)
ORGAN-TOBRAIN WT
RATIO
10 412.5
85.7
10 1.0319 0.1956
10 0.2563 0.0631
10 0.4776 0.1015
M9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 725.1
76.6
F9
NUMBER IN GROUP: MEAN:
STANDARD DEV:
10 396.4
49.5
10 1.0749 0.2526
10 0.2753 0.0763
10 0.5268 0.1225
TABLE 50 Incidence of M acroscopic O bservations
Week 4 S a c r i f i c e
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T - 6 3 1 6 . 1
PAGE: 1
TABLE INCLUDES: S E X = A L L ;G R O U P= 1,2, 3, 4 , 5 ; W E E K S = A L L DEATH=1;SUBSET=T
ORGAN AND KEYWORD(S) OR PHRASE ** T O P O F LIST ** G E N E R A L C O M M E N T (GC) ........
NO MACROSCOPIC LESIONS L I V E R (L I ) .....................
** E N D O F LIST **
-- N U M B E R - 0 F - A N I M A L S - A F F E C T E D --SEX: GROUP: -1- -2- -3- -4- -5- -1- -2- -3- -4- -5NUMBER: 5 5 5 5. 5 5 5 5 5 5
NUMBER EXAMINED:
5
5
5
5
5
5
5
5
5
5
5 5 555S 55 55
NUMBER EXAMINED:
5
5
5
5
5
5
5
5
5
5
NOT REMARKABLE:
5
5
5
5
5
5
5
S
5
5
co
Co
Ci CQ
TABLE 51
Incidence of Macroscopic Observations Week 4 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 1
TABLE INCLUDES: SEX=AL L ; G R O U P= 8 , 9 ; W E EKS=ALL DEATH=1;SUBSET=T
--- N U M B E R - O F - A N I M A L S - A F F E C T E D ---SEX: -- MALE -- -FEMALEGROUP: -8- - 9- -8- -9-
ORGAN AND KEYWORD!S) OR PHRASE
NUMBER: 5 5 5 5.
** T O P O F LIST **
G E N E R A L C O M M E N T (GC) ........................ ............. N U M B E R EXAMINED:
5
5
5
5
NO MACROSCOPIC LESIONS
5555
L I V E R (LI) .....................................
5555 NOT REMARKABLE: 5 5 5 5
** E N D O F L I S T **
TABLE 52 Incidence of Macroscopic Observations
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M-T6316.1
PAGE: 1
TABLE INCLUDES: SEX=ALL ;GROUP=l,5 ;WEEKS=ALL DEATH=2 ;SUBSET=ALL
ORGAN AND KEYWORD(S) OR PHRASE
** TOP OF LIST ** GENERAL COMMENT (GC) ....... e o NO MACROSCOPIC LESIONS
Co BONE MARROW SMEAR TAKEN Co LUNG (LU) .................. (0 Co MOTTLED
LIVER (LI) .................
LIGHT FOCUS(I)/AREA(S) LARGE MOTTLED DIFFUSELY DARK DEPRESSED FOCUS (I )/AREA (S )
THYMUS (TH) ...............
RED FOCUS(I)/AREA(S)
-- NUMBER -(
SEX: -- MALE-- -FEMALE-
GROUP: -1- -5- -1- -5-
NUMBER: 5 5 5 5
NUMBER EXAMINED: 5 5 5 5
4 04 1 55S5
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 4 5 5 5
1000
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 0 S 2
0100 0502 0001 02 0 2 0100
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 5 5 4
0001
ANIMALS-AFFECTED---
TABLE 52 Incidence of Macroscopic Observations
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M-T6316.1
PAGE: 2
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2;SUBSET=ALL
ORGAN AND KEYWORD(S) OR PHRASE
ADRENAL, CORTEX (AC) .......
DIFFUSELY RED STOMACH, GL (ST) ...........
DARK FOCUS(I)/AREA(S) RED FOCUS (I) /AREA(S) CECUM (CE) .................
DIFFUSELY RED UTERUS (UT) ................
LUMEN FILLED WITH FLUID LN, MANDIBULAR (MN) ........ .
DIFFUSELY RED
-- N U M B E R - O F - A N I M A L S - A F F E C T E D ----
SEX: -- MALE-- -FEMALE-
GROUP: -1- -5- -1- -5-
NUMBER: 5 5 5 .5
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 4 5 5
0100
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 3 5 4
0101 0100
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 4 5 5
0100
NUMBER EXAMINED: 0 0 5 5 NOT REMARKABLE: 0 0 5 4
0001
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 4 5 4 5
1010
TABLE 52 Incidence of Macroscopic Observations
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M-T6316.1
PAGE: 3
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2 ;SUBSET=ALL
ORGAN AND KEYWORD(S) OR PHRASE
CAVITY, ABDOM (PC)
c0 EDEMA END OF LIST ** o. Cv
CD
01
-- N U M B E R - O F SEX -- MALE-- -FEMALEGROUP -1- -5- -1- -5NUMBER 5 5 5 5
ANIMALS
A F F E C T E D ---
NUMBER EXAMINED: 5 5 NOT REMARKABLE: 5 4
5 5
0 10
5 5
0
TABLE 53 Incidence of Macroscopic Observations
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 1
TABLE INCLUDES:
SEX=ALL;GR0UP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
-- NUMB ER -0 F -AN IMALS SEX: .--- MALE- -- ______ ___ _-- FEMALE--
GROUP: -1-
-3- -4-
O--R---G---A--N---A--ND KE--Y-W--O--R--D--(--S--)-----O---R----P--H--R---A--S--E----------------------- -------- --------------
** TOP OF LIST ** GENERAL COMMENT (GC) .....................
----------------- --N--U--MB--E--R: - 3 -5 ------5 ~=--5 ~ 35- - ----5 - 3 -5 - --5- - --5-
55 5 55 555
oo NO MACROSCOPIC LESIONS BONE MARROW SMEAR TAKEN URINARY BLADDER-SMALL LUMEN Co
C O KIDNEY (KD) ..............................
CD
<75 LARGE PELVIS(ES)
22 54 3 424
05
05
05
05
05
05
5 1
05
5555 5 555 NOT REMARKABLE: 4 5 5 5 5 5 5 5
10000000
LIVER (LI) ...............................
5555555 5 NOT REMARKABLE: 4 5 5 5 5 5 5 5
MOTTLED
10000000
THYMUS (TH) ..............................
5 5555555 NOT REMARKABLE: 4 5 5 5 5 5 5 5
MOTTLED
1 00 00 000
STOMACH, GL (ST) .........................
555 55555 NOT REMARKABLE: 4 4 5 5 4 5 3 4
DARK FOCUS(I)/AREA(S) RED FOCUS (I) /AREA(S)
00000010 11 0 01 011
TABLE 53 Incidence of Macroscopic Observations
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 2
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL
ORGAN AND KEYWORD(S) OR PHRASE
SKIN (SK) ......................
cUK ALOPECIA-FOCAL RED FOCUS(I)/AREA(S)
Co
C O PROSTATE (PR) .................. LARGE
SEMINAL VESICLES (SV) ..........
LARGE UTERUS (UT) ....................
LUMEN FILLED WITH FLUID OVARY (OV) .....................
CYST(S)
--- N U M B E R - O F - A N I M A L S - A F F E C T E D ----
SEX: -------- M A L E -------- -------FEMALE-
GROUP: -1- -2- -3- -4- -1- -2- -3- -4-
NUMBER: 5 5 5 5 5 5 5 5
NUMBER EXAMINED: 5 5 5 5 5 5 5 5 NOT REMARKABLE: 5 5 5 4 5 5 4 5
00000010 00010000
NUMBER EXAMINED: 5 5 5 5 0 0 0 0 NOT REMARKABLE: 4 5 5 5 0 0 0 0
10000000
NUMBER EXAMINED: 5 5 5 5 0 0 0 0 NOT REMARKABLE: 4 5 5 5 0 0 0 0
10000000
NUMBER EXAMINED: 0 0 0 0 5 5 5 5 NOT REMARKABLE: 0 0 0 0 5 5 4 5
00000010
NUMBER EXAMINED: 0 0 0 0 5 5 5 5 NOT REMARKABLE: 0 0 0 0 4 5 5 5
000010 00
TABLE 53 Incidence of Macroscopic Observations
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 3
TABLE INCLUDES: SEX=ALL;GROUP=l ,2,3,4;WEEKS=ALL DEATH=3; SUBSET=ALL
ORGAN AND KEYWORD(S) OR PHRASE
N UMBER -0F -AN IMA LS
SEX: -.--- MALE-- --
-- ---FEMALE--
GROUP: -1- -2- -3- -4- -1- -2- -3- -4-
NUMBER: 5 5 5 5 5 5 5 5
LN, MANDIBULAR (MN) ....................... ......... NUMBER EXAMINED: 5 5 5 5 5 5 5 5 NOT REMARKABLE: 4 3 5 5 5 4 4 5
DIFFUSELY RED RED FOCUS(I)/AREA(S) ** END OF LIST **
12000010 00000100
003398
TABLE 54 Incidence of Macroscopic observations
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 1
TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=2;SUBSET=T
ORGAN AND KEYWORD(S) OR PHRASE
** TOP OF LIST **
GENERAL COMMENT (GC) .......
Co
Co NO MACROSCOPIC LESIONS CD LIVER (LI) .................
CD ** END OF LIST **
-- NUMBER-OF-ANIMALS-AFFECTED --
SEX: -- MALE-- -FEMALE-
H
GROUP: -8- -9- -8- -9-
NUMBER: 5 5 5 5
NUMBER EXAMINED: 5 5 5 5
55 5 5
NUMBER EXAMINED: 5 5 S 5 NOT REMARKABLE: 5 5 5 5
TABLE 55 Incidence of Macroscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 1
C03400
TABLE INCLUDES: SEX=ALL ;GR0UP=1,4;WEEKS=ALL DEATH=4 ;SUBSET=ALL
ORGAN AND KEYWORD(S) OR PHRASE
** TOP OF LIST ** GENERAL COMMENT (GC) .....
NO MACROSCOPIC LESIONS BLOOD FILM TAKEN DISCHARGE-OCULAR MALOCCLUSION BONE MARROW SMEAR TAKEN TEETH MISSING/BROKEN/WORN
BRAIN (BR) ...............
COMPRESSED (HYPOTHALAMUS)
LUNG (LU) ................
LIGHT FOCUS(I)/AREA!S)
LIVER (LI) ............
LIGHT FOCUS (I) /AREA(S) MOTTLED
-- N U M B E R - 01 F SEX:: -MALE-- -FEMALEGROUP:: -1- -4- -1- -4NUMBER: 5 10 5 10
A N I M A L S - A F F E C T E D --
NUMBER EXAMINED:
NUMBER EXAMINED NOT REMARKABLE:
NUMBER EXAMINED: NOT REMARKABLE:
NUMBER EXAMINED: NOT REMARKABLE:
5 10
33 5 10 01 04 5 10 03
5 10 59
01
5 10 5 10
00
5 10 5 10
00 00
5 10
21 5 10 00 02 5 10 01
5 10 58
02
5 10 58
02
5 10 49
01 10
TABLE 55 Incidence of Macroscopic observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GROUP=l,4;WEEKS=ALL DEATH=4;SUBSET=ALL
ORGAN AND KEYWORD (S) OR PHRASE
-- N U M B E R - O F - A N I M A L S SEX: -MALE-- -FEMALEGROUP: -1- -4- -1- -4NUMBER: 5 10 5 10
LN, MESENTERIC (MS) .....................
DIFFUSELY RED ADRENAL, CORTEX (AC) ....................
DARK FOCUS(I)/AREA(S) PITUITARY (PI) ..........................
MASS(ES) DARK FOCUS (I) /AREA(S) RED FOCUS (I)/AREA(S) STOMACH, GL (ST) ........................
DARK FOCUS(I)/AREA(S) MAMMARY, FEMALE (MF) ....................
MASS(ES) CYST(S)
NOT REMARKABLE: NOT REMARKABLE: NOT REMARKABLE:
NOT REMARKABLE: NOT REMARKABLE:
5 10 5 10
00
5 10 4 10
10
5 10 58
02 00 00
5 10 59
01
00 00
00 00
5 10 59
01
5 10 5 10
00
5 10 47
02 10 01
5 10 44
16
5 10 48
01 12
Covance G329-212 3M T-6316.1
PAGE: 2
A F F E C T E D --
TABLE 55 Incidence of Macroscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GR0UP=1,4;WEEKS=ALL DEATH=4;SUBSET=ALL
ORGAN AND KEYWORD(S) OR PHRASE
-- N U M B E R - O F - A N I M A L S SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4NUMBER: 5 10 5 10
UTERUS (UT) ........................
LUMEN FILLED WITH FLUID CYST(S) THICKENED WALL OVARY (OV) .........................
CYST(S) LN, MANDIBULAR (MN) ................
DIFFUSELY RED CAVITY, ABDOM (PC) .................
MASS(ES) TAIL (TI) ..........................
RAISED AREA(S)
** END OF LIST **
NOT REMARKABLE:
NOT REMARKABLE: NOT REMARKABLE: NOT REMARKABLE: NOT REMARKABLE:
00 00
00 00 00
00 00
00
5 10 49
11
5 10 5 10
00
5 10 5 10
00
5 10 38
11 10 01
5 10 59
01
5 10 4 10
10
5 10 59
01
5 10 59
01
Covance 6329-212 3M T-6316.1
PAGE: 3
A F F E C T E D --
TABLE 56 Incidence of Macroscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX-ALL;GROUP-8, 9;WEEKS-ALL DEATH-3;SUBSET-ALL
ORGAN AND KEYWORD(S ) OR PHRASE ** TOP OF LIST ** ^ GENERAL COMMENT (GC) ..... O NO MACROSCOPIC LESIONS
f - MALOCCLUSION
TT ANIMAL OBESE W * BONE MARROW SMEAR TAKEN Q TEETH MISSING/BROKEN/WORN
C O BRAIN (BR) ...............
COMPRESSED (HYPOTHALAMUS)
LUNG (LU) ................
LIGHT FOCUS(I)/AREA(S )
KIDNEY (KD) ...........
LARGE PELVIS(ES) CYST (S)
SEX; -MALE-- -FEMALE-
GROUP: -8- -9- -8- -9-
NUMBER:
10 10
1 1 1o 1 1-* 1O
NUMBER EXAMINED: 10 10 10 10
l422 0011 7301 10 10 10 10 0010
NUMBER EXAMINED: 10 10 10 10 NOT REMARKABLE: 10 10 10 9
0001
NUMBER EXAMINED: 10 10 10 10 NOT REMARKABLE: 10 10 9 10
0010
NUMBER EXAMINED: 10 10 10 10 NOT REMARKABLE: 10 9 10 9
0100 0001
Covance 6329-228 3M T-6316.1
PAGE: 1
003404
TABLE 56 Incidence of Macroscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX-ALL;GROUP-8, 9;WEEKS-ALL DEATH-3;SUBSET-ALL
ORGAN AND KEYWORD(S) OR PHRASE
NUMBER-( SEX: -MALE-- -FEMALEGROUP: -8- -9- -8- -9NUMBER: 10 10 10 10
LIVER (LI) ............................
LIGHT FOCUS(I )/AREA(S ) MOTTLED RED FOCUS(I)/AREA(S) SPLEEN (SP) ...........................
LIGHT FOCUS (I )/AREA (S ) ADRENAL, CORTEX (AC) ..................
LARGE PITUITARY (PI) ........................
DARK FOCUS(I)/AREA(S ) LARGE DIFFUSELY RED RED FOCUS(I)/AREA(S )
10 10 10 10 NOT REMARKABLE: 8 10 9 10
1000 1000 00l0
10 10 10 10 NOT REMARKABLE: 10 9 10 10
0100
10 10 10 10 NOT REMARKABLE: 10 10 9 10
0010
10 10 10 10 NOT REMARKABLE: 10 9 5 8
0010 0142 0001 0021
Covance 6329-228 3M T-6316.1
PAGE: 2
A F F E C T E D --
oo
Co
o&
cn
TABLE 56 Incidence of Macroscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T - 6 3 1 6 . 1
PAGE: 3
TABLE INCLUDES: SEX=ALL;GROUP-8, 9,-WEEKS-ALL DEATH-3;SUBSET-ALL
ORGAN AND KEYWORD(S) OR PHRASE
NUM BER-OF-ANIMALS-AFFECTED --
SEX: -- MALE-- -FEMALE-
GROUP: -8- -9- -8- -9-
NUMBER:
10 10 ip
1 1IlHo*
STOMACH, GL (ST) ...........................
DARK FOCUS(I)/AREA!S) SKIN (SK) ..................................
CRUSTED AREA(S ) MAMMARY, FEMALE (MF) .......................
MASS(ES) CYST(S) UTERUS (UT) ................................
CYST(S) TESTIS (TE) ................................
SMALL
10 10 10 10 NOT REMARKABLE: 10 10 8 10
0020
10 10 10 10 NOT REMARKABLE: 10 10 10 9
0001
0 NOT REMARKABLE: 0
0 10 10 065
0012 0034
0 NOT REMARKABLE: 0
0 10 10 0 10 9
0001
10 10 0 0 NOT REMARKABLE: 10 9 0 0
0100
TABLE 56 Incidence of Macroscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1*) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-228 3M T-6316.1
PAGE: 4
TABLE INCLUDES: SEX-ALL;GROUP-8, 9;WEEKS-ALL DEATH-3;SUBSET-ALL
ORGAN AND KEYWORD(S) OR PHRASE
-- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: --MALE-- -FEMALEGROUP: -8- -9- -8- -9NUMBER: 10 10 10 10
LN, AXILLARY (AX) ..........
DIFFUSELY RED LN, MANDIBULAR (MN) ........
DIFFUSELY RED MOTTLED
** END OF LIST **
NUMBER EXAMINED: 10 10 10 10 NOT REMARKABLE: 10 10 9 10
0010
NUMBER EXAMINED: 10 10 10 10 NOT REMARKABLE: 10 10 8 7
0022 0001
TABLE 57 Incidence of M icroscopic O bservations
Week 8 S a c r i f i c e
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (9 8 .1 % ) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2;FIND=ALL;SUBSET=ALL
NUM BER-1 SEX: -- MALE-- -FEMALEGROUP: -1- -5- -1- -5-
ORGAN AND FINDING DESCRIPTION
--------- --------------N-U-M--B-E-R-:-
5
5
_c
5
_--_
_ =5_
** TOP OF LIST **
EYE (EY) ..................................
55 5 5
NOT REMARKABLE: 5 5 5 5
(-1
BRAIN (BR) ................................. Co
55 55
NOT REMARKABLE: 5 5 5 5
O SPINAL CORD (SC) ........................... ri
KIDNEY (KD) ................................
-- CAST, PROTEINACEOUS -- CYST -- MINERALIZATION, TUBULAR -- NEPHROPATHY, CHRONIC PROGRESSIVE
LIVER (LI ) .................................
-- HEMORRHAGE -- HYPERTROPHY, HEPATOCELLULAR -- INFLAMMATION, CHRONIC -- NECROSIS, HEPATOCELLULAR -- VACUOLATION, HEPATOCELLULAR
5555
NOT REMARKABLE: 5 5 5 5
5555 NOT REMARKABLE: 3 4 5 4
1000
I100 0001 0100
5 5 55 NOT REMARKABLE: 3 0 4 0
03 01
05
15
2000
03 01
0100
Covance 6329-212 3M T - 6 3 1 6 . 1
PAGE: 1
TABLE 57 Incidence of M icroscopic O bservations
Week 8 S a c r i f i c e
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (9 8 .1 % ) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T - 6 3 1 6 . 1
PAGE: 2
TABLE INCLUDES: SEX-ALL;GROUPAI,5,-WEEKS=ALL DEATH=2; FINOALL; SUBSET=ALL
ORGAN AND FINDING DESCRIPTION
THYMUS (TH) ......
ofv?-;S -- HEMORRHAGE Cj
LN, MESENTERIC (MS)
o
Q O -- HEMORRHAGE SPLEEN (SP) ......
PITUITARY (PI)
ADRENAL, CORTEX (AC)
ADRENAL, MEDULLA (MA)
-- N U M B E R - O F SEX: -- MALE-- -FEMALEGROUP: -1- -5- -1- -5NUMBER: 5 5 5 5
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 4 5 5 3 1002
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 4 S 5 5 1000
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 5 5 5
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 5 5 5
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 5 5 5
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 5 5 5
ANIMALS-AFFECTED
TABLE 57 Incidence of M icroscopic O bservations
Week 8 S a c r i f i c e
1 0 4 -WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (9 8 .1 % ) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RA.TS
o e-
o&
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2;FIND=ALL;SUBSET=ALL
ORGAN AND FINDING DESCRIPTION STOMACH, N O N G L (SU) ..........
STOMACH, G L (ST) ............. .
D U O D E N U M (D U ) ..................
J E J U N U M (JE) ...................
P A N C R E A S (PA) ..................
E P I D I D Y M I D E S (EP) .............
SEX: -- MALE -- -FEMALEGROUP: -1- - 5- -1- -5NUMBER: 5 5 5 5
NUMBER EXAMINED: 5 5 5 5 NOT REMARKABLE: 5 5 5 5
NUMBER EXAMINED: 5 5 5 5
NOT REMARKABLE:
5
5
5
5
NUMBER EXAMINED:
5
5
5
5
NOT REMARKABLE:
5
5
5
5
NUMBER EXAMINED:
5
5
5
5
NOT REMARKABLE:
5
5
5
5
NUMBER EXAMINED:
5
5
5
5
NOT REMARKABLE:
5
5
5
5
NUMBER EXAMINED:
5
5
0
0
NOT REMARKABLE: 5 5 0 0
Covance 6329-212 3M T - 6 3 1 6 . 1
PAGE: 3
TABLE 57 Incidence of M icroscopie O bservations
Week 8 S a c r i f i c e
X0 4 -WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE ( 9 8 . 1 i | N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T - 6 3 1 6 . 1
PAGE: 4
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2;FIND=ALL; SUBSET=ALL
ORGAN AND FINDING DESCRIPTION
--- N U M B E R - O F - A N I M A L S - A F F E C T E D ----
SEX: -- M A L E -- -FEMALE-
'
GROUP: -1- -5- -1- -5-
NUMBER:
5
5
5
5
T E S T I S (TE) ........................
O O C o O V A R Y (OV) ..........................
H
V A G I N A (VA) ........................
O
5500
NOT REMARKABLE:
5
5
0
0
005 5
NOT REMARKABLE:
0
0
5
5
0055
NOT REMARKABLE:
0
0
5
5
U T E R U S (UT) ........................
0001
NOT REMARKABLE:
0
0
0
0
-- DILATATION
0001
LN, M A N D I B U L A R (MN) ............... ........................ N U M B E R EXAMINED:
1
0
1
0
NOT REMARKABLE: 0 0 0 0
-- HEMORRHAGE
10 10
LN, M E D I A S T I N A L (ML) ............. ........................ N U M B E R EXAMINED:
0
0
0
1
MOT REMARKABLE: 0 0 0 0
-- HEMORRHAGE
0001
CAVITY, A B D O M (PC) ................
0100
NOT REMARKABLE:
0
0
0
0
-- EDEMA
0100
** E N D O F LIST
TABLE 58 Incidence of M icroscopic O bservations
Week 14 S a c r i f i c e
1 0 4 -WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (9 8 .1 % ) N-ETHYL FERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T - 6 3 1 6 . 1
PAGE: I
C-v &
TABLE INCLUDES: S E X - A L L ;G R O U P - 1 , 2 , 3 , 4 ; W E E K S - A L L DEATH-3;FIND-ALL;SUBSET-ALL
N U M B E R -0 F -ANIMA L S AFFECTED
SEX:
----M A L E ---
GROUP: -1- -2- -3- -4-
--- F E M A L E -- -1- _ 4OL_ -3-
-4-
ORGAN AND FINDING DESCRIPTION
NUMBER:
-- -- -- -- ----- -- -- -- ---------------------------------- ---------------- ------------------------------------ -- -- -- --------_ _ _ _ _ _ _ _ _
** T O P O F LIST ** E Y E (EY) ................................ ..................... N U M B E R E X AMINED:
NOT REMARKABLE:
5
-- *--
5 5
5
~= --
5 5
5
-- as--
5 5
5. 5 -- = -- -- SB--
55 55
5
-- SS--
5 5
5 -- SS--
5 5
5
--= --
5 5
B R A I N (BR) .............................
55555555
NOT REMARKABLE:
5
5
5
5
5
5
5
5
K I D N E Y (KD) .................................................. N U M B E R EXAMINED:
5
5
5
5
5
5
5
5
NOT REMARKABLE: 3 3 5 5 5 5 4 4
-- CAST, PROTEINACEOUS -- CYST -- DEGENERATION, TUBULAR -- DILATATION, PELVIC -- HYPERPLASIA, TRANSITIONAL CELL -- INFLAMMATION, CHRONIC -- MINERALIZATION, TUBULAR -- PYELONEPHRITIS
1 0 00 00 0 0 00000001 0 1 00 00 0 0 10000000 1 0 000 0 0 0 01000000 00000010 10000000
L I V E R (LI) ................................................... N U M B E R E XAMINED:
5
5
5
5
5
5
5
5
NOT REMARKABLE:
3
1
1
0
3
1
3
2
-- HEMATOPOIESIS, EXTRAMEDULLARY -- HEMORRHAGE -- HYPERTROPHY, HEPATOCELLULAR -- INFLAMMATION, CHRONIC -- VACUOLATION, HEPATOCELLULAR
1000 0 00 0
10 00 1 000
0 135 0 002
1
1
3
0
1
4
rt i.
2
02210000
TABLE 58 Incidence of M icroscopic O bservations
Week 14 S a c r i f i c e
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (9 8 .1 % ) N-ETHYL PERFLUOROOCTANE3ULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: S E X A L L ; G R O U P = l , 2, 3, 4 ; W E E K S = A L L DEATH=3; FIND=ALL;SUBSET=ALL
o
O
c-
pU
W
ORGAN AND FINDING DESCRIPTION
..........
LN, M E S E N T E R I C (MS) .....................
-- HEMORRHAGE -- INFILTRATE, MACROPHAGE, PIGMENTED
S P L E E N (SP) ..............................
ADRE N A L , C O R T E X (AC) .....................
-- VACUOLATION ADRENAL, M E D U L L A (MA)
P A N C R E A S (PA)
-- FIBROSIS -- PIGMENT
T E S T I S (TE) .
--ATROPHY/DEGENERATION O V A R Y (OV) ................
-- HEMORRHAGE ** E N D O F LIST **
NUMB E R - 0 F - ANI M A L S SEX: GROUP: -1- -2- - 3- -4- -1- -2- -3- -4NUMBER: 5 5 5 5 5 5 5 5
NUMBER EXAMINED: 4 5 5 5 5 5 5 5
NOT REMARKABLE:
4
5
4
5
5
5
4
5
0 0 10 0 0 1 0 0 000 0 010
NUMBER EXAMINED:
5
5
5
5
5
5
5
5
NOT REMARKABLE:
5
5
5
5
5
5
5
5
NUMBER EXAMINED:
5
5
5
5
5
5
5
5
NOT REMARKABLE:
3
2
4
4
5
5
5
4
23110001
NUMBER EXAMINED:
5
5
5
5
5
5
5
5
NOT REMARKABLE: 5 5 5 5 5 5 5 5
NUMBER EXAMINED:
5
5
5
5
5
5
5
5
NOT REMARKABLE:
4
5
4
5
5
5
5
5
10000000 10100000
NUMBER EXAMINED:
5
5
5
5
0
0
0
0
NOT REMARKABLE:
5
5
4
5
0
0
0
0
00100000
NUMBER EXAMINED:
0
0
0
0
5
5
5
5
NOT REMARKABLE:
0
0
0
0
5
5
5
4
00000001
Covance 6329-212 3M T - 6 3 1 6 . 1
PAGE: 2
TABLE 60 Incidence of S ev erity of M icroscopic O bservations
Week fi S a c r i f i c e
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMI DO ETHANOL IN RATS
Covance 6329-212 3M T 6 3 1 6 . 1
PAGE: 1
cwroo
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2; FIND=ALL; SU8SET=T
-- N UM BERSEX: -- MALE-- -FEMALEGROUP: -1- -5- -1- -5-
ORGAN/TISSUE EXAMINED
-- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- ----------------- - -- -- -- -- -- -- -- -- -- -- --
** T O P O F L I S T ** L I V E R (LI) ................................
-- HEMATOPOIESIS, EXTRAMEDULLARY
NUMBER:
5
-- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- **
->
TL> MN>
5 5 5 0.0
5
-- --
5 5 5 0.0
5
-- SS--
5 5 5 0.0
5
--= --
5 5 S 0.0
-- HEMORRHAGE
-> 1> 3> TL> MN>
5 0 0 5 0.0
2 3 0 5 0.6
5 0 0 5 0.0
4 0 1 5 0.6
-- HYPERTROPHY, HEPATOCELLULAR
-> 1> 3> 4> TL> MN>
5 0 0 0 5 0.0
0 0 5 0 5 3.0
4 1 0 0 5 0.2
0 0 4 1 5 3.2
-- INFLAMMATION, CHRONIC ** CONTINUED ON NEXT PAGE **
"> 3 1> 2 TL> 5 MN> 0.4
5
0
5
0.0
5
0
S
0.0
5
0
5
0.0
ANIMALS-AFFECTED
Il> ? 0 9
TABLE 60 Incidence of S everity of M icroscopic O bservations
Week 8 S a c r i f i c e
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GROUP=l, 5;WEKS=ALL DEATH-2;FIND-ALL;SUBSET-T
ORGAN/TISSUE EXAMINED ** FROM P R E V I O U S PAGE * L I V E R (L I ) ......................................
-- NECROSIS, HEPATOCELLULAR
-- VACUOLATION, HEPATOCELLULAR
** E N D O F L IS T **
-- mum B E R -
SEX: -- M A L E -- -FEMALE-
GROUP: -1- -5- -1- -5-
NUMBER:
5
5
5
5
-> 1> 3> TL> MN>
5 5 0 0 5 0.0
5 2 1 2 5 1.4
5 5 0 0 5 0.0
5 4 0 1 5 0.6
-> 1> TL> MN>
5 0 5 0.0
4 1 5 0.2
5 0 5 0.0
5 0 5 0.0
Covance 6329-212 3M T 6 3 1 6 . 1
PAGE: 2
A F F E C T E D ---
G
C-
v\
TABLE 61 Incidence of S everity of M icroscopic O bservations
Week 14 S a c r i f i c e
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GROUP=l, 2,3,4;WEEKS=ALL DEATH=3;FIND-ALL;SUBSET=T
ORGAN/TISSUE EXAMINED ** T O P O F LIST ** L I V E R (LI) ...........................
-- HEMATOPOIESIS, EXTRAMEDULLARY
-- HEMORRHAGE
-- HYPERTROPHY, HEPATOCELLULAR
-- INFLAMMATION, CHRONIC
* * CONTINUED ON NEXT PAGE 4 4
-- SEX:
N UM B ER -O F-A N IM A LS
----M A L E -- --
-- -- FEMALE--
GROUP: -1-
NUMBER: 5 5 5 & 5 5 5 5
--
-= -
-as- -as- --s- -s-
NUMBER
EXAMINED: ->
1> TL> MN>
5 4 1 5 0.2
5 5 0 5 0.0
5 5 0 5 0.0
5 5 0 5 0.0
5 5 0 5 0.0
5 5 0 S 0.0
5 5 0 5 0.0
5 5 0 5 0.0
-> 1> 3> TL> MN>
4 1 0 5 0.2
5 0 0 5 0.0
5 0 0 5 0.0
5 0 0 5 0.0
4 0 1 5 0.6
5 0 0 5 0.0
5 0 0 5 0.0
5 0 0 5 0.0
->
1> 2> 3> TL> MN>
5 0 0 0 5 0.0
4 1 0 0 5 0.2
2 1 1 1 5
1.2
0 0 4 1 5 2.2
5 0 0 0 5 0.0
5 0 0 0 5 0.0
5 0 0 0 5 0.0
3 0 2 0 5 0.8
-> 1> 2> TL> MN>
4 0 1 5 0.4
4 1 0 5
0.2
2 3 0 5 0.6
5 0 0 5 0.0
4 1 0 5 0.2
1 4 0 5 0.8
3 2 0 5 0.4
3 2 0 5 0.4
Covance 6329-212 3M T 6 3 1 6 .1
PAGE: 1
TABLE 61 Incidence of S ev erity of M icroscopic O bservations
Week 14 S a c r i f i c e
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
co cn
TABLE INCLUDES: SEX=ALL;GROUP=l,2,3, 4;WEEKS=ALL D E A T H " 3; FINDALL; S U B S E T !
-- NUM
R -O F-A N IM A LS
SEX: --------M A L E -- --
-- -- FEMALE--
GROUP: -1- -2- -3- -4- -1- -2- -3- -4-
ORGAN/TISSUE EXAMINED
NUMBER: 5
----------------- -- ----------------------------------- -------------------------- --------3 --
** FROM P R E V I O U S PAGE **
L I V E R (L I ) ........................................ .......... N U M B E R E X A M I N E D :
-- NECROSIS, HEPATOCELLULAR
->
5 5
TL> 5
MN> 0.0
5 -= --
5 5 5 0.0
5 --= --
5 5 5 0.0
5 --SS--
5 5 5 0.0
5 --= --
5 5 5 0.0
5 -- ss--
5 5 5 0.0
5 --= --
5 5 5 0.0
5 --SS--
5 5 5 0.0
-- VACUOLATION, HEPATOCELLULAR ** E ND O F LIST
-> 1> 2> 3> TL> MN>
5 0 0 0 5 0.0
3 1 1 0 5 0.6
3 1 0 1 5 0.8
4 1 0 0 5 0.2
5 0 0 0 5 0.0
5 0 0 0 5 0.0
5 0 0 0 5 0.0
5 0 0 0 5 0.0
Covance 6329-212 3M T 6 3 1 6 .1
PAGE: 2
<>
c
e.>
a
TABLE 59 Incidence of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 1
TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL
ORGAN AND FINDING DESCRIPTION
** TOP OF LIST ** EYE (EY) ......
-- NUMBER-OF-ANIMALS-AFFECTED -- SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4NUMBER: 5 10 5 10
NUMBER EXAMINED: 5 10 NOT REMARKABLE: 5 10
5 10 5 10
BRAIN (BR)
-- COMPRESSION, VENTRAL
LIVER (LI) .............
-- DEGENERATION, CYSTIC -- FOCUS, ALTERED HEPATOCELLULAR, EOSINOPHILIC -- FOCUS, ALTERED HEPATOCELLULAR, BASOPHILIC -- HYPERPLASIA, BILE DUCT -- HYPERTROPHY, HEPATOCELLULAR -- INFLAMMATION, CHRONIC -- NECROSIS, HEPATOCELLULAR -- STASIS, BILE -- VACUOLATION, HEPATOCELLULAR -- B-ADENOMA, HEPATOCELLULAR
KIDNEY (KD) ...................................
-- CAST, PROTEINACEOUS -- INFLAMMATION, CHRONIC ** CONTINUED ON NEXT PAGE **
NUMBER EXAMINED: NOT REMARKABLE:
NUMBER EXAMINED: NOT REMARKABLE:
NUMBER EXAMINED: NOT REMARKABLE:
5 10 5 10
00
5 10 10
00 00 10 00 0 10 31 01 01 09 00
5 10 07
31 00
5 10 58
02
5 10 42
01 01 00 01 07 11 02 02 02 01
5 10 15
03 20
C Co
05
TABLE 59 Incidence of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1*) N-ETHYL PERFLUOROOCTANESULFQNAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 2
TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4 ;FIND-ALL;SUBSET-ALL
--- N U M B E R - 1 F - A N I M A L S - A F F E C T E D
SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4-
ORGAN AND FINDING DESCRIPTION
NUMBER: 5 10 5 10
** FROM PREVIOUS PAGE ** KIDNEY (KD) .......................... .............. NUMBER EXAMINED:
NOT REMARKABLE:
5 10 07
5 10 15
-- MINERALIZATION, PELVIC -- MINERALIZATION, TUBULAR -- NEPHROPATHY, CHRONIC PROGRESSIVE
1122 0021 2100
SPLEEN (SP) ..........................
5 10 NOT REMARKABLE: 5 10
5 10 5 10
PANCREAS (PA) ....................................... NUMBER EXAMINED: 5 10 NOT REMARKABLE: 4 8
-- ATROPHY, ISLET CELLS -- FIBROSIS -- INFLAMMATION, CHRONIC -- PIGMENT
10 01 01 01
ADRENAL, CORTEX (AC) ...................
5 10 NOT REMARKABLE: 3 9
-- ANGIECTASIS -- DEGENERATION, CYSTIC, CORTICAL -- FIBROSIS -- HEMORRHAGE -- HYPERTROPHY, CORTICAL CELL -- 'VACUOLATIQN
00 10 00 10 10 11
5 10 5 10
00 00 00 00
5 10 18
20 02 01 40 00 00
GWroo
1 111 1 1111111 11 1 1 111 1 1 1111111111 1 1 1 1 1 1111 1 1 1 111
TABLE 59 Incidence of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL
NUM BER-1 SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4-
ORGAN AND FINDING DESCRIPTION
-- ---- -------
NUMBER: 5 10 5 10 --as-- ---- --="
ADRENAL, MEDULLA (MA) ...................... ........ NUMBER EXAMINED: 5 10 NOT REMARKABLE: 5 9
5 10 5 10
-- HEMORRHAGE -- B-PHEOCHROMOCYTGMA
0100 0100
LN, MESENTERIC (MS) ........................
5 10 NOT REMARKABLE: 5 9
5 10 59
-- HEMORRHAGE -- INFILTRATE, MACROPHAGE, PIGMENTED
0101 0100
OVARY (OV) .................................
0 0 5 10 NOT REMARKABLE: 0 0 5 7
-- CYST -- HEMORRHAGE
0002 0002
TESTIS (TE) ................................
5 10 0 0 NOT REMARKABLE: 5 9 0 0
-- ATROPHY/DEGENERATION
0100
BONE, FEMUR (FE) ...........................
5 10 NOT REMARKABLE: 5 10
5 10 5 10
Covance 6329-212 3M T-6316.1
PAGE: 3
TABLE 59 Incidence of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL
ORGAN AND FINDING DESCRIPTION
MARROW, FEMUR (FM) ..........
NUM BER-1
SEX: -- MALE-- -FEMALE-
GROUP: -1- -4- -1- -4-
NUMBER: --*5-- 10
5 10
5 10 NOT REMARKABLE: 5 10
5 10 5 10
MARROW, STERNUM (SE) ........
c - BONE, STERNUM (SB) ..........
it*
THYMUS (TH) .................
-- FIBROSIS -- HEMORRHAGE
SPINAL CORD (SC) ............
5 10 NOT REMARKABLE: 5 10
5 10 5 10
5 10 NOT REMARKABLE: 5 10
5 10 5 10
NOT REMARKABLE: NOT REMARKABLE:
59 49
00 10
5 10 5 10
5 10 59
01 00
5 10 5 10
LN, MANDIBULAR (MN) ......... -- HEMORRHAGE
NOT REMARKABLE:
5 10 49
11
5 10 4 10
10
Covance 6329-212 3M T-6316.1
PAGE: 4
TABLE 59 Incidence of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFQNAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL
ORGAN AND FINDING DESCRIPTION
LUNG (LU) ......................... .........
-- HYPERPLASIA, MEDIAL, ARTERIAL/ARTERIOLAR o -- MINERALIZATION, VASCULAR
-- INFILTRATE, MACROPHAGE, ALVEOLAR -- INFILTRATE, MACROPHAGE, PIGMENTED c.-<
HEART (HT) ..................................
-- DEGENERATION/NECROSIS MUSCLE, SKELETAL (SM) .......................
NUM BER-1
SEX: -- MALE-- -FEMALE-
GROUP: -1- -4- -1- -4-
NUMBER: 5 10
5 10 --a--
5 10 NOT REMARKABLE: 4 7
5 10 48
NOT REMARKABLE:
01 11 11 00
5 10 59
00 00 12 01
5 10 5 10
0100
5 10 NOT REMARKABLE: 5 10
5 10 5 10
NERVE, SCIATIC (SN) .........................
5 10 NOT REMARKABLE: 5 10
5 10 5 10
THYROID (TY) ................................
-- CYST, FOLLICULAR -- CYST, ULTIMOBRANCHIAL -- B-ADENOMA, C-CELL -- B-ADENOMA, FOLLICULAR CELL
NOT REMARKABLE:
5 10 37
01 22 00 00
5 10 33
00 26 01 01
Covance 6329-212 3M T-6316.1
PAGE: 5
A F F E C T E D --
TABLE 59 Incidence of Microscopie Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance G329-212 3M T-6316.1
PAGE: 6
TABLE INCLUDES: SEX-ALL;GROUP-1, 4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL
ORGAN AND FINDING DESCRIPTION
-- N U M B E R - O F - A N I M A L S - A F F E C T E D --
SEX: -- MALE-- -FEMALE-
*
GROUP: -1- -4- -1- -4-
NUMBER: 5 10 5 10
PARATHYROID (PT) ..................
-- HYPERPLASIA
TRACHEA (TR) ......................
to ESOPHAGUS (ES) ....................
NOT REMARKABLE: NOT REMARKABLE:
5 10 4 10
10
5 10 5 10
59 59
00
5 10 5 10
5 10 NOT REMARKABLE: 5 10
5 10 5 10
PITUITARY (PI) ...................................... NUMBER EXAMINED: NOT REMARKABLE:
-- CYST -- HEMORRHAGE -- HYPERPLASIA -- B-ADENOMA
SALIV GL, MANDIB (SG) ............. ................. NUMBER EXAMINED: NOT REMARKABLE:
5 10 34
00 02 03 23
5 10 5 10
5 10 35
01 01 00 24
5 10 5 10
TABLE 59 Incidence of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 7
TABLE INCLUDES: SEX-ALL;GROUP-1,4 ;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL
ORGAN AND FINDING DESCRIPTION
N U M B E R - 1O F - A N I M A L S - A F F E C T E D -SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4NUMBER: 5 10 5 10
HARDERIAN GLAND (HG) ..................
-- INFLAMMATION, CHRONIC O O STOMACH, GL (ST) ...................... Co
-- EDEMA
to -- EROSION CO STOMACH, NONGL (SU) ...................
NOT REMARKABLE: NOT REMARKABLE: NOT REMARKABLE:
5 10 5 10
00
5 10 59
00 01
5 10 5 10
5 10 59
01
5 10 48
10 02
5 10 5 10
DUODENUM (DU) .........................
5 10 NOT REMARKABLE: 5 10
5 10 5 10
JEJUNUM (JE) ..........................
5 10 NOT REMARKABLE: 5 10
5 10 5 10
ILEUM (IL) ............................
5 10 NOT REMARKABLE: 5 10
5 10 5 10
TABLE 59 Incidence of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 8
TABLE INCLUDES: SEX=ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL
ORGAN AND FINDING DESCRIPTION
N U M B E R - O( F - A N I M A L S - A F F E C T E D -SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4NUMBER: 5 10 5 10
CECUM (CE) ............. .............
5 10 NOT REMARKABLE: 5 10
5 10 5 10
COLON (CO) ........................... .............. NUMBER EXAMINED: NOT REMARKABLE:
-- PARASITISM
RECTUM (RE) ..........................
NOT REMARKABLE:
-- PARASITISM
SKIN (SK) ............................
NOT REMARKABLE:
5 10 59
01
5 10 59
01
5 10 5 10
5 10 5 10
00
5 10 4 10
10
5 10 5 10
MAMMARY, FEMALE (MF) .................
-- GALACTOCELE -- M-CARCINOMA PROSTATE (PR) ........................
-- INFLAMMATION, CHRONIC
NOT REMARKABLE: NOT REMARKABLE:
00 00
00 00
5 10 3 10
10
5 10 48
11 01
00 00
00
TABLE 59 Incidence of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1*) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL
-- NUM BER-I SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4-
ORGAN AND FINDING DESCRIPTION
NUMBER:. 5 10 5 10 --OE-- --3--
** FROM PREVIOUS PAGE **
PROSTATE (PR) ....................................... NUMBER EXAMINEEDD: 5 10 0 0
NOT REMARKABLE: 3 10 0 0
-- INFLAMMATION, CHRONIC-ACTIVE
1000
URINARY BLADDER (UB) ................................ NUMBER EXAMINED: 5 10 NOT REMARKABLE: 5 10
5 10 5 10
c-
c- EPIDIDYMIDES (EP) ................................... NUMBER EXAMINED: 5 10 0 0 NOT REMARKABLE: 5 10 0 0
ro
on SEMINAL VESICLES (SV) ............................... NUMBER EXAMINED: 5 10 0 0 NOT REMARKABLE: 5 10 0 0
VAGINA (VA) ......................................... NUMBER EXAMINED: 0 0 5 10 NOT REMARKABLE: 0 0 5 10
CERVIX (CV) ......................................... NUMBER EXAMINED: 0 0 5 10 NOT REMARKABLE: 0 0 5 10
Covance 6329-212 3M T-6316.1
PAGE: 9
TABLE 59 Incidence of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 10
TABLE INCLUDES: SEX-ALL;GROUP-1,4 ;WEEKS-ALL DEATH-4; FIND-ALL;SUBSET-ALL
ORGAN AND FINDING DESCRIPTION
-- N U M B E R - < SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4NUMBER: 5 10 5 10
A N I M A L S - A F F E C T E D --
UTERUS (UT) .....................................
-- DILATATION -- HYPERPLASIA, CYSTIC, ENDOMETRIAL
LN, MEDIASTINAL (ML) ............................ Cj !li -- HEMORRHAGE W -- INFILTRATE, MACROPHAGE, PIGMENTED V) CAVITY, ABDOM (PC) ..............................
-- FIBROSIS -- NECROSIS, FAT
LN, LUMBAR/1LIAC (U4) ...........................
TAIL (TI) .......................................
-- INFLAMMATION, ACUTE -- B-KERATQACANTHOMA
** END OF LIST **
0 0 5 10 NOT REMARKABLE: 0 0 3 8
0021 0001
0002 NOT REMARKABLE: 0 0 0 0
0002 0002
0001 NOT REMARKABLE: 0 0 0 0
00 0 1 0001
0001 NOT REMARKABLE: 0 0 0 1
0001 NOT REMARKABLE: 0 0 0 0
0001 0001
TABLE 60 Incidence of S ev erity of M icroscopic O bservations
Week 8 S a c r i f i c e
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GROUP"!,5;WEEKS-ALL DEATH=2;FIND=ALL;SUBSET-T
-- NUM BER-1 SEX: -- MALE-- -FEMALEGROUP: -1- -5- -1- -5-
ORGAN/TISSUE EXAMINED
NUMBER: 5 5 5 5.
------------ --------------
------------------------------------------------------------------------- ------------------------ --=-- --**-- --S3-- --S--
** TOP OF LIST ** LIVER (LI) .............................
-- HEMATOPOIESIS, EXTRAMEDULLARY
5555 -> 5 5 5 5
TL> 5 5 5 5 MN> 0.0 0.0 0.0 0.0
-- HEMORRHAGE
-> 5 2 5 4 1> 0 3 0 0 3> 0 0 0 1 TL> 5 5 5 5 MN> 0.0 0.6 0.0 0.6
-- HYPERTROPHY, HEPATOCELLULAR
-> 5 0 4 0 1> 0 0 1 0 3> 0 5 0 4 4> 0 0 0 1 TL> 5 5 5 5 MN> 0.0 3.0 0.2 3.2
-- INFLAMMATION, CHRONIC ** CONTINUED ON NEXT PAGE **
-> 3 5 5 5 1> 2 0 0 0
TL> 5 5 5 5 MN> 0.4 0.0 0.0 0.0
Covance 6329-212 3M T6316.1
PAGE: 1
TABLE 60 Incidence of Severity of Microscopic Observations
Week 8 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1*) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=2; FIND=>ALL; SUBSET-T
ORGAN/TISSUE EXAMINED ** FROM PREVIOUS PAGE ** LIVER (LI) .................
-- NECROSIS, HEPATOCELLULAR
-- VACUOLATION, HEPATOCELLULAR
** END OF LIST **
SEX: -- MALE-- -FEMALE-
GROUP: -1- -5- -1- -5-
NUMBER: 5 5 5 5
NUMBER EXAMINED: 5 5 5 5 -> 5 2 5 4 1> 0 1 0 0 3> 0 2 0 1
TL> 5 5 5 5 MN> 0.0 1.4 0.0 0.6
-> 5 4 5 5 1> 0 1 0 0 TL> S 5 5 5 MN> 0.0 0.2 0.0 0.0
Covance 6329-212 3M T6316.1
PAGE: 2
-AFFECTED --
TABLE 61
Incidence of Severity of Microscopic Observations Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T6316.1
PAGE: 1
TABLE INCLUDES: SEX^ALL; GROUP-1,2,3,4; WEEKS-ALL DEATH=3;FIND=ALL;SUBSET=T
ORGAN/TISSUE EXAMINED ** TOP OF LIST ** LIVER (LI) ......................
-- HEMATOPOIESIS, EXTRAMEDULLARY
-- HEMORRHAGE
-- HYPERTROPHY, HEPATOCELLULAR
-- INFLAMMATION, CHRONIC
** CONTINUED ON NEXT PAGE **
-- N U M B E R - O F - A N I M A L S - A F F E C T E D ---
SEX: ------ MALE------ ----- FEMALE-----
,
GROUP: -1- -2- -3- -4- -1- -2- -3- -4-
NUMBER: 5 5 5 5
5555
mino ino
NUMBER EXAMINED: 5 5 5
555
->455
555
1> 1 0 0 0 0 0
TL> 5 5 5 5 5 5
MN> 0.2 0.0 0.0 0.0
-> 4 5 5 5 4 5 5 5
1> 1 0 0 0 0 0 0 0 3> 0 0 0 0 1 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.2 0.0 0.0 0.0 0.6 0.0 0.0 0.0
-> 5 4 2 0 5 5 5 3
1> 0 1 1 0 0 0 0 0 2> 0 0 1 4 0 0 0 2 3> 0 0 1 1 0 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.0 0.2 1.2 2.2 0.0 0.0 0.0 0.8
-> 4 4 2 5 4 1 3 3 1> 0 1 3 0 1 4 2 2 2> 1 0 0 0 0 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.4 0.2 0.6 0.0 0.2 0.8 0.4 0.4
TABLE 61 Incidence of Severity of Microscopic Observations
Week 14 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX-ALL;GROUP-1,2,3,4; WEEKS-ALL DEATH-3;FIND-ALL;SUBSET-T
-- NUM B ER -O F-A N IMA LS
S E X : --- --- MALE-- --
-- -- FEMALE--
GROUP: -1- -2- -3- -4- -1- -2- -3- -4-
ORGAN/TISSUE EXAMINED
----------- -- -- -- -- -- -- -- -- -- -- -- ----------_ _ _ _ _ _ _ ----- ----------
** FROM PREVIOUS PAGE **
LIVER (LI) ........................................... -- NECROSIS, HEPATOCELLULAR
---- -- -- ---- -- -- -- -- -- -- -- ---- -- ---- --
NUMBER:
-- -- ---- -- -- -- -- -- -- -- -- --
-> TL> MN>
5
-- S--
5 5 0.0
5
-- E=--
5 5 5 0.0
5
-- SS--
5 5 5 0.0
5
--K --
5 5 5 0.0
5
--B --
5 5 5 0.0
5
--S --
5 5 5 0.0
5
--K --
5 5 5 0.0
5
-- SS--
5 5 5 0.0
-- VACUOLATION, HEPATOCELLULAR END OF LIST **
-> 5
1> 0 2> 0 3> 0 TL> 5 MN> 0.0
3 1
1
0
5 0.6
3 1
0
1
5 0.8
4 1
0
0
5 0.2
5 0
0
0
5
0.0
5
0 0
0
5
0.0
5
0 0
0
5
0.0
5
0
0 0
5
0.0
Covance 6329-212 3M T6316.1
PAGE: 2
TABLE 62 Incidence of Severity of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
TABLE INCLUDES: SEX-ALL;GROUP*1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-T
ORGAN/TISSUE EXAMINED ** TOP OF LIST ** LIVER (LI) .......................
-- DEGENERATION, CYSTIC
-- FOCUS, ALTERED HEPATOCELLULAR, EOSINOPHILIC
-- FOCUS, ALTERED HEPATOCELLULAR, BASOPHILIC
-- HEMATOPOIESIS, EXTRAMEDULLARY
-- HEMORRHAGE ** CONTINUED ON NEXT PAGE **
ta] CO
-- NUM
R-1
SEX: -- MALE-- -FEMALE-
GROUP: -1- -4- -1- -4-
NUMBER: 5 10 5 10
NUMBER EXAMINED: 5 10 5 10 -> 5 10 5 9 1> 0 0 0 1
TL> 5 10 5 10 MN> 0.0 0.0 0.0 0.1
-> 5 10 5 9 4> 0 0 0 1 TL> 5 10 5 10 MN> 0.0 0.0 0.0 0.4
-> 4 10 5 10 2> 1 0 0 0 TL> 5 10 5 10 MN> 0.4 0.0 0.0 0.0
"> 5 10 5 10 TL> 5 10 5 10 MN> 0.0 0.0 0.0 0.0
-> 5 10 5 10 TL> 5 10 5 10 MN> 0.0 0.0 0.0 0.0
Covance 6329-212 3M T-6316.1
PAGE: 1
A F F E C T E D --
TABLE 62 Incidence of Severity of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Covance 6329-212 3M T-6316.1
PAGE: 2
TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS--ALL DEATH-4;FIND-ALL;SUBSET-T
-- NUM BER-OF-ANIMALS-AFFECT ED-- SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4-
ORGAN/TISSUE EXAMINED
NUMBER: 5 10
5 10
-------------------------__________------- - ------------------------------------------------------------------- ---- -- -- --*-- --at--
** FROM PREVIOUS PAGE ** LIVER (LI) .........................
-- HYPERPLASIA, BILE DUCT
5 10 5 10 -> 5 10 5 9
1> 0 0 0 1 TL> 5 10 5 10 MN> 0.0 0.0 0.0 0.1
O -- HYPERTROPHY, HEPATOCELLULAR
o
c-
& CO
M -- INFLAMMATION, CHRONIC
-> 5 0 5 3
2> 0 3 0 3
3> 0 2 0 4
4> 0 5 0 0
TL> 5 10
5 10
MN> 0.0 3.2 0.0 1.8
-> 2 9 4 9 1> 3 1 1 0 2> 0 0 0 1 TL> 5 10 5 10
MN> 0.6 0.1 0.2 0.2
-- NECROSIS, HEPATOCELLULAR ** CONTINUED ON NEXT PAGE **
-> 5 9 5 8
1> 0 1 0 1 3> 0 0 0 1 TL> 5 10 5 10 MN> 0.0 0.1 0.0 0.4
CCV"00
TABLE 62 Incidence of Severity of Microscopic Observations
Week 53 Sacrifice
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMI DO ETHANOL IN RATS
TABLE INCLUDES: SEX-ALL;GROUP-1,4 ;WEEKS-ALL DEATH-4 ;FIND-ALL;SUBSET-T
-- NUMBER-1 SEX: -- MALE-- -FEMALEGROUP: -1- -4- -1- -4-
ORGAN/TISSUE EXAMINED
NUMBER: 5 10
5 IP
------------------------------ ------------------------------------------------------------------ ---------------------------------- --JB--
--S-- --St
** FROM PREVIOUS PAGE **
LIVER (LI) ............................................ NUMBER EXAMINED: 5 10
-- STASIS, BILE
-> 5 9
5 10 58
1> 0 l 0 1
2> 0 0 0 1
TL> 5 10
5 10
MN> 0.0 0.1 0.0 0.3
-- VACUOLATION, HEPATOCELLULAR
-> 5 1 5 8 1> 0 3 0 2 2> 0 3 0 0 3> 0 3 0 0 TL> 5 10 5 10 MN> 0.0 1.8 0.0 0.2
-- B-ADENOMA, HEPATOCELLULAR
-> 5 10 +> 0 0 TL> 5 10
59 01 5 10
-- X-HEMATOPOIETIC NEOPLASIA (SEE "HEMATO NEOPLASIA" FOR TYPE) ** END OF LIST **
-> 5 10 TL> 5 10
5 10 5 10
Covance 6329-212 3M T-6316.1
PAGE: 3
- A F F E C T E D --
Covance 6329-212 3M T-6316.1
Table 63
Results of Homogeneity Analyses (ppm) Mixed 9/11/97
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Sample Location Replicate 3
____ T-6316 (ppm)_____ 30 100 300
Top
1 6.28 38.0 95.3
322
2 6.35 32.2 90.9
277
3 6.24 33.7 93.5
296
Mean 6.29 (210)* 34.6 (115) 93.2 (93.2) 298 (99.3)
Middle
1 2 3 Mean
5.17 5.65 5.89 5.57(186)
33.9 34.1 34.9 34.3 (114)
102 143 96.8 114(114)
286 271 266 274(91.3)
Bottom
1 2 3 Mean
6.61 5.24 5.37 5.74(191)
32.9 35.9 32.7 33.8(113)
109 108 99.4 105 (105)
325 334 278 312(104)
a Each value in parenthesis is the percent of theoretical
00*2434
Covance 6329-212 3M T-6316.1
Table 63 (Continued)
Results of Homogeneity Analyses (ppm) Mixed 9/29/97
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
T-6316 (ppm) Sample Location Replicate 3_________
Top 1 3.98 2 4.26 3 30.0
Mean 12.7 (423)1
Middle
1 2 3 Mean
4.00 4.14 3.87 4.00 (133)
Bottom
1 2 3 Mean
4.32 3.98 4.20 4.17(139)
a Each value in parenthesis is the percent of theoretical.
^ '^ u 4 3 S
Covance 6329-212 3M T-6316.1
Table 63 (Continued)
Results of Homogeneity Analyses (ppm) Mixed 10/15/97
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMEDO ETHANOL IN RATS
T-6316 (ppm) Sample Location Replicate 3__________
Top 1 3.18 2 2.99 3 3.23
Mean 3.13(104)*
Middle
1 2 3 Mean
3.44 3.19 3.32 3.32(111)
Bottom
1 2 3 Mean
3.06 3.98 3.34 3.46 (115)
a Each value in parenthesis is the percent of theoretical.
C-0- 4 3 6
Covance 6329-212 3M T-6316.1
Table 63 (Continued)
Results of Homogeneity Analyses (ppm) Mixed 11/7/97
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
_____ T-6316 (ppm) Sample Location Replicate 3__________ 300
Top
1 2.73
296
2 3.19
305
3 3.53
302
Mean 3.15 (105)' 301 (100)
Middle
1 2 3 Mean
3.67 2.51 2.83 3.00 (100)
304 300 297 300 (100)
Bottom
1 2 3 Mean
3.12 2.91 3.12 3.05 (102)
293 278 328 300 (100)
a Each value in parenthesis is the percent of theoretical.
C-03437
Covance 6329-212 3M T-6316.1
Table 63 (Continued)
Results of Homogeneity Analyses (ppm) Mixed 11/13/97
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Sample Location Replicate 3
T-6316 (ppm) 300
Top
1 2.93
290
2 2.86
314
3 2.91
291
Mean 2.90 (96.7)* 298 (99.3)
Middle
1 2 3 Mean
2.65 2.90 2.87 2.81 (93.7)
288 302 293 294 (98.0)
Bottom
1 2 3 Mean
2.66 2.84 3.40 2.97 (99.0)
284 269 308 287 (95.7)
a Each value in parenthesis is the percent of theoretical.
Covance 6329-212 3M T-6316.1
Table 63 (Continued)
Results of Homogeneity Analyses (ppm) Mixed 1/15/98
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Sample Location Replicate 3
T-6316 (ppm) 30 100
300
Top
1 2.89
31.8
89.4 275
2 2.54
27.9
93.7 278
3 2.63
29.0
99.2 294
Mean 2.69 (89.7)* 29.6 (98.7) 94.1 (94.1) 282 (94.0)
Middle
1 2 3 Mean
2.67 2.66 2.83 2.72 (90.7)
28.9 29.8 27.2 28.6 (95.3)
87.4 82.2 90.8 86.8 (86.8)
280 300 289 290 (96.7)
Bottom
1 2 3 Mean
3.02 8.49 3.07 4.86 (162)
27.9 27.0 28.0 27.6 (92.0)
89.1 101 105 98.4 (98.4)
291 283 278 284 (94.7)
Bottom15
1 2 3 Mean
3.68 2.52 3.19 3.13 (104)
_
-
-
-
"
a Each value in parenthesis is the percent of theoretical, b Reassay.
C'03439
Covance 6329-228 3M T-6316.1
Table 64
Results o f Homogeneity Analyses (ppm) Mixed 3/30/98
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
______T-6316 (ppm) Sample Location Replicate 1
Top 1 0.824 2 1.01 3 0.906
Mean 0.913 (91.3)1
Middle
1 2 3 Mean
1.02 0.894 0.900 0.938 (93.8)
Bottom
1 2 3 Mean
0.766 1.28 1.13 1.06(106)
a Each value in parenthesis is the percent of theoretical.
03440
Covance 6329-212 3M T-6316.1
Table 65
Results o f Stability Analyses (ppm) Mixed 9/11/97
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
T-6316 (ppm)
Storage Conditions Replicate 3
300
Initial
1 2 Mean
7.57 271 4.70 292 6.14(205)' 282 (94.0)
19 days, room temperature
1 2 Mean
-
215 207 211 (70.3)
a Each value in parenthesis is the percent of theoretical.
003441
Covance 6329-212 3M T-6316.1
Table 65 (Continued)
Results of Stability Analyses (ppm) Mixed 9/29/97
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMBDO ETHANOL IN RATS
T-6316 (ppm) Storage Conditions Replicate 3
Initial
1 2 Mean
4.00 4.47 4.24 (141)'
a Each value in parenthesis is the percent of theoretical.
C 0^44
Covance 6329-212 3M T-6316.1
Table 65 (Continued)
Results of Stability Analyses (ppm) Mixed 10/15/97
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
T-6316 (ppm)
Storage Conditions Replicate 3
300
Initial"
1 2 Mean
3.44 302 3.19 292 3.32 ( l l l ) b 297 (99.0)
19 days, room temperature
1 2 Mean
2.83 250 3.13 270 2.98 (99.3) 260 (86.7)
34 days, room temperature
1 2 Mean
2.90 266 3.09 266 3.00 (100) 266 (88.7)
8 weeks, frozen
1 2 Mean
3.12 275 2.79 291 2.96 (98.7) 283 (94.3)
a Results were derived from the sample collected from the middle of the dose preparations for homogeneity analysis.
b Each value in parenthesis is the percent of theoretical.
C 0J443
Covance 6329-212 3M T-6316.1
Table 65 (Continued)
Results of Stability Analyses (ppm) Mixed 11/13/97
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
T-6316 (ppm) Storage Conditions Replicate 3__________ 300
5 days, room temperature 7 days, animal room conditions
1 2 3 Mean
4.16 3.42 3.00 3.53 (118)'
264 258 267 263 (87.7)
a Each value in parenthesis is the percent of theoretical.
C03444
Covance 6329-228 3M T-6316.1
Table 66
Results o f Stability Analyses (ppm) Mixed 3/30/98
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Interval
T-6316 (ppm) Replicate 1
Initial*
1 2 3 Mean
1.02 0.894 0.900 0.938 (93.8)b
21 days, room temperature
1 2 Mean
0.892 0.842 0.867 (86.7)
32 days, room temperature
1 2 Mean
1.39 1.20 1.30(130)
a Results were derived from the sample collected from the middle of the dose preparations for homogeneity analysis.
b Each value in parenthesis is the percent of theoretical.
C-0;i445
Covance 6329-228 3M T-6316.1
Table 66 (Continued)
Results of Stability Analyses (ppm) Mixed 6/5/98
104-WEEK DETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Interval
T-6316 (ppm) Replicate 1
Initial
1 2 Mean
0.966 1.13 1.05 (105)b
32 days, room temperature
1 2 Mean
0.828 0.808 0.818(81.8)
46 days, room temperature
1 2 Mean
1.06 0.902 0.981 (98.1)
b Each value in parenthesis is the percent of theoretical.
003446
Covance 6329-212 3M T-6316.1
Table 67
Results o f D ose Preparation Analyses (ppm)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Week Replicate 0 3
T-6316 (ppm) 30 100
300
l-3a 1 b 2.67
28.9 87.4 280
2 b 2.66
29.8 82.2 300
3 - 2.83
27.2 90.8 289
Mean -
2.72 (90.7)c 28.6 (95.3) 86.8 (86.8) 290 (96.7)
4-7 1 b 5.64 29.0 90.4 292
2 b 3.10
27.0 97.5 301
Mean -
4.37 (146) 28.0(93.3) 94.0 (94.0) 297 (99.0)
4-7d 1
2.81
..
2 - 3.05
-
-
-
Mean -
2.93 (97.7) -
-
-
8-11 1 b 4.53
29.9 84.3 278
2 b 3.45
28.1 86.5 262
Mean -
3.99 (133) 29.0 (96.7) 85.4 (85.4) 270 (90.0)
8-1 l d
1 _ 2.66
_
2 - 3.20
-
-
Mean -
2.93 (97.7) -
-
-
12-15
1 2 Mean
b b -
3.34 2.67 3.01 (101)
26.9 35.6 31.3 (104)
98.2 99.1 98.7 (98.7)
-
a Results for the 3-, 30-, 100-, and 300-ppm levels were derived from the sample collected from the middle of the dose preparations for homogeneity analysis,
b Below the limit of quantitation (<2.00 ppm), c Each value in parenthesis is the percent of theoretical, d Reassay.
003447
Covance 6329-212 3M T-6316.1
Table 67 (Continued)
Results o f D ose Preparation Analyses (ppm)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Week Replicate 0 3
T-6316 (ppm) 30 100
300
16-19
1 e 3.77
39.3
87.2
2 e 3.04
31.5
93.0
-
Mean - 3.41 (114)c 35.4(118) 90.1 (90.1) -
16-19d
1 2 Mean
_ -
2.78 21.8 2.20 44.6 2.49 (83.0) 33.2 (111)
_ -
-
16-19*
1 _ 2.62
26.9
2 - 2.52
23.3
Mean - 2.57 (85.7) 25.1 (83.7)
-
-
20-23
1 e 2.61 27.7 101
2 e 2.41
26.4
92.3
-
Mean - 2.51 (83.7) 27.1 (90.3) 96.7 (96.7) -
20-23d
1 2 Mean
-
2.15 2.47 2.31 (77.0)
-
_---
20-23f
1 2 Mean
-
2.14 1.90 2.02 (67.3)
-
_ --
"
c Each value in parenthesis is the percent of theoretical, d Reassay e Below the limit of quantitation (<0.5 ppm) f Retention.
C03448
Covance 6329-212 3M T-6316.1
Table 67 (Continued)
Results o f D ose Preparation Analyses (ppm)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMDO ETHANOL IN RATS
Week Replicate 0 3
T-6316 (ppm) 30 100
300
24-27
1 2 Mean
e e
-
2.63 24.1 83.3 3.04 26.7 88.4 2.84 (94.7)c 25.4 (84.7 ) 85.9 (85.9)
-
24-27d
1 2 Mean
-
-
25.3 24.0 24.7 (82.3)c
. -
-
24-27f
1 2 Mean
_ -
-
22.4 21.4 21.9(73.0)
-
-
28-31
1 2 Mean
e e
-
2.24 2.52 2.38 (79.3)
26.4 28.4 27.4 (91.3)
87.5 86.0 86.8 (86.8)
_ -
28-3 l d
1 2 Mean
-
3.20 2.60 2.90 (96.7)
-
---
28-3 l f
1 2 Mean
-
3.20 2.73 2.97 (99.0)
-
---
32-35
1 2 Mean
e e
-
2.92 2.46 2.69 (89.7)
28.2 29.7 29.0 (96.7)
83.4 85.9 84.7 (84.7)
"
c Each value in parenthesis is the percent of theoretical, d Reassay. e Below the limit of quantitation (<0.5 ppm) f Retention.
00,3449
Covance 6329-212 3M T-6316.1
Table 67 (Continued)
Results o f D ose Preparation Analyses (ppm)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
Week Replicate 0 3
T-6316 (ppm) 30 100
300
36-39
1 2 Mean
e e
-
3.36 2.58 2.97 (99.0)c
24.9 91.4 22.7 87.2 23.8 (79.3) 89.3 (89.3)
-
36-39d
1 2 Mean
-
2.53 2.51 2.52 (84.0)
23.0 22.8 22.9 (76.3)
-
-
36-39f
1 2 Mean
_ -
2.82 2.68 2.75 (91.7)
27.0 29.6 28.3 (94.3)
-
-
40-43
1 2 Mean
e e
-
3.01 5.26 4.14(138)
28.9 28.3 28.6 (95.3)
95.5 99.5 97.5 (97.5)
_ -
40-43d
1 2 Mean
_ -
2.73 2.71 2.72 (90.7)
. -
----
44-47
1 2 Mean
e e
-
3.97 2.77 3.37(112)
29.3 27.9 28.6 (95.3)
84.4 95.8 90.1 (90.1)
-
44-47d
1 2 Mean
_ -
2.93 2.04 2.49 (83.0)
-
64.0 59.6 61.8(61.8)
-
c Each value in parenthesis is the percent of theoretical, d Reassay. e Below the limit of quantitation (<0.5 ppm), f Retention.
C0a450
Covance 6329-212 3M T-6316.1
Table 67 (Continued)
Results o f D ose Preparation Analyses (ppm)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAM3DO ETHANOL IN RATS
Week Replicate 0 3
T-6316 (ppm) 30 100
300
44-47f
1 2 Mean
-
-
5.30 2.75 4.03 (134)c
-
60.4 58.4 64.4 (64.4)
-
48-51 52-53
1 2 Mean
1 2 Mean
e e
-
e e -
2.67 2.59 2.63 (87.7)
3.22 3.45 3.34 (111)
30.2 29.0 29.6 (98.7)
25.2 24.0 24.6 (82.0)
97.8 94.7 96.3 (96.3)
92.5 97.6 95.1 (95.1)
-
_
-
52-53" 52-53f 52-53*
1 2 Mean
-
-
1 2 Mean
-
-
1 2 Mean
"
-
_
-
-
-
20.4 21.0 20.7 (69.0)
-
-
-
19.0 21.5 20.3 (67.7)
_
-
-
-
88.4 .. - 84.5 - 86.5 (86.5) -
c Each value in parenthesis is the percent of theoretical, d Reassay. e Below the limit of quantitation (<0.5 ppm), f Retention, g Additional mix.
003451
Covance 6329-228 3M T-6316.1
Table 68
Results o f D ose Preparation Analyses (ppm)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAJVnDO ETHANOL IN RATS
T-6316 (ppm)
Week Replicate 0
1
r
1b
1.02
2b
0.894
3-
0.900
Mean -
0.938 (93.8)c
2-5
1b
0.782
2b
0.668
Mean -
0.725 (72.5)
2-5d
1_
1.12
2-
1.04
Mean -
1.08 (108)
6-9 1 0.848 1.48
2b
1.53
Mean -
1.51 (151)
6-9d
1b
0.890
2b
0.858
Mean -
0.874 (87.4)
a Results for the 1 ppm level were derived from the sample collected from the middle of the dose preparations for homogeneity analysis.
b Below the limit of quantitation (<0.5 ppm), c Each value in parenthesis is the percent of
the theoretical, d Reassay.
C 034S2
Covance 6329-228 3M T-6316.1
Table 68 (Continued)
Results o f D ose Preparation Analyses (ppm)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
T-6316 (ppm)
Week Replicate 0
1
10-13
1 2 Mean
b b
-
0.966 1.13 1.05 (105)*
14-17
1 2 Mean
b b
-
0.894 0.870 0.882 (88.2)
18-21 18-21d
1 2 Mean
1 2 Mean
b b
-
*
-
1.69 1.07 1.38 (138)
0.880 1.26 1.07 (107)
18-21*
1 2 Mean
-
0.789 0.704 0.747 (74.7)
22-25
1 2 Mean
b b
-
0.798 0.876 0.837 (83.7)
b Below the limit of quantitation (<0.5 ppm), c Each value in parenthesis is the percent of
the theoretical, d Reassay, e Retention.
03453
Covance 6329-228 3M T-6316.1
Table 68 (Continued)
Results o f D ose Preparation Analyses (ppm)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
T-6316 (ppm)
Week Replicate 0
1
26-29
1 2 Mean
b b -
8.81 1.88 5.35 (535)c
26-29d
1 2 Mean
-
-
0.730 0.786 0.758 (75.8)
26-29e
1 2 Mean
-
-
0.902 0.936 0.919(91.9)
30-33
1 2 Mean
b b -
1.05 1.32 1.19(119)
30-33d
1 2 Mean
_
-
-
0.951 0.955 0.953 (95.3)
34-37
1 2 Mean
b b -
1.02 1.00 101 (101)
b Below the limit of quantitation (<0.5 ppm), c Each value in parenthesis is the percent of
the theoretical, d Reassay, e Retention.
Covance 6329-228 3M T-6316.1
Table 68 (Continued)
Results o f D ose Preparation Analyses (ppm)
104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS
T-6316 (ppm)
Week Replicate 0
1
38-41
1 2 Mean
b b
-
0.836 1.16 0.998 (99.8)c
42-45
1 2 Mean
b b -
0.912 0.886 0.899 (89.9)
46-49
1 2 Mean
b b
-
0.781 0.705 0.743 (74.3)
50-53
1 2 Mean
b b -
0.895 2.18 1.54 (154)
50-53d
1 2 Mean
-
0.916 0.904 0.910(91.0)
b Below the limit of quantitation (<0.5 ppm), c Each value in parenthesis is the percent of
the theoretical, d Reassay.
003455
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