Document wD9wON7y1naxrV9Y1RddEzN5D

ARX&- 095& %M - OiOO _ b 73 <* Summary Report 104-Week DietarwyiCthhProenrficluTorooxoiccittaSynaealntSd(uPlCFfoaOnrScici:nTAo-gc6ei2dn9iPc5io)ttyiansSsRtiuuadmtys r EPA-OTS 000811793T 0DDflll?T3T CoD fCC\JD_' as i rC\ T PREPAR3MED FOR: COVANCE6S3T29U-D18Y3 NUMBER: mCCiDD X r--vj C5--2O"~:D*a2jsOmmr<odn 002148 SUMMARY REPORT - WEEK 53 104 Week Dietary Toxicity and Carcinogenicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Rats Timeline Covance 6329-183: In-life start date: April 20,1998 Week 53 completed: April 25, 1999 Introduction The purpose of this study is to assess the chronic toxicity and carcinogenicity of the test material, T-6295 (Perfluorooctane sulfonic acid potassium salt, PFOS), 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 n o t, however, the final report for the study. Covance Laboratories Inc. reserves the right of review of these data before issuing a final report. Methods Male and female Crl:CD*(SD)IGS BR rats were assigned to groups according to the following design: Group Number of Animals Male Female (DpipemtarTy-L62e9ve5l)sc 1 (Control)abd 2 (Low)" 3 (Mid)b 4 (Mid-High)b 5 (High)M 6 (Mid-High Recovery) 766000 . 477000 70 4667700000 0 2200025.....50000 ba TFihveecaonnitmroallsa/nseimx ainlsGrercoeuipvsed1tthherobuagshal5dwieetroenslya.crificed during Weeks 4 and 14 for hepatocellular proliferation rate measurements, c Tabci-ot6ic2vh9ite5ymiaiscnapalelyrasfnleuaso,lyrasoneodsct(hapinastelomspuiatlotfhyooln-liCocgoayAci(dWoxpeidoetakatsi1os4inu)om,nmly(Pi)t,FocOhSo)n;ddroiasel levels are expressed as ppm of T-6295 d Tsaecnriafinciemaanlism/saexls.inTGhreosuepasni1maanlds w5 ewreerseadcreisfiigcneadteadftearsaint tleeraismt 52 weeks of treatment.. 1 002149 Covanc3eM63T29-6-128935 Observation of Animals 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. Clinical Pathology. Blood and urine samples were collected for hematology, clinical chemistry, urinalysis, and urine chemistry from 10 animals/sex/group in Groups 1 through 5 during Weeks 4, 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. 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 from animals sacrificed during Week 53. Serum PFOS Analyses. During Weeks 4 and 14, blood samples were collected for serum analyses from five animals/sex/group in Groups 1 through 5. During Week 53, blood samples were collected from five animals/sex/group in Groups 1 and 5. Animals were fasted overnight. Blood (approximately 2 mL) was collected from a jugular vein, allowed to clot at room temperature, and centrifuged. Samples were collected without anticoagulant. Serum was harvested and stored in a freezer, set to maintain -60 to -80 C, until sent to the Sponsor for analyses of PFOS levels. Termination. During Weeks 4 and 14, five animals/sex/group/interval in Groups 1 through 5 were fasted overnight, bled for serum chemistry, anesthetized with carbon dioxide, weighed, and exsanguinated. The abdominal cavity of each animal was opened, the liver was removed and weighed. Liver samples were collected for palmitoyl-CoA, cell proliferation, and PFOS concentration analyses and for mitochondrial activity (Week 4 sacrifice only) and histopathology (Week 14 sacrifice only). Animals sacrificed during Week 4 were discarded after liver collection. During Week 53, 10 animals/sex/group from 2 002150 Covance 6329-183 3M T-6295 Groups 1 and 5 were fasted overnight, bled for serum samples (five animals/sex/group), anesthetized with carbon dioxide, weighed, exsanguinated, and necropsied. The liver was weighed and liver samples were collected and frozen for analysis. Animals sacrificed during Weeks 14 and 53 had macroscopic observations recorded, selected organs weighed, and selected tissues collected and preserved. Adrenals, brain, eyes, kidneys, liver, mesenteric lymph node, pancreas, spleen, testes, and ovaries were processed and examined microscopically from animals sacrificed during Week 14 and on all tissues from the animals in Groups 1 and 5 that were necropsied during Week 53. Animals that died or were sacrificed at unscheduled intervals were also necropsied and microscopic examinations were done on selected tissues collected, but organ weights were not recorded. A blood film was taken for each animal sacrificed at unscheduled intervals and at the Week 53 interim sacrifice. Proliferation Cell Nuclear Antigen (PCNA) Evaluation. During the Week 4 and 14 tissue collections from animals in Groups 1 through 5 (five animals/sex/group), representative samples of the left lateral lobe and any macroscopic lesions of the liver were collected and preserved in zinc formalin. Liver samples were fixed and 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. Palmitoyl-CoA (PCoA) Oxidase Analyses. During the Week 4 and 14 tissue collections from animals in Groups 1 through 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. The samples were stored in a freezer set to maintain -60 to -80C, until analyzed by Covance for PCoA oxidase activity. PFOS Analysis. During the Week 4 and 14 tissue collections for animals in Groups 1 through 5 (five animals/sex/group) and Week 53 for animals in Groups 1 and 5 (five animals/sex/group), a portion of the remaining liver was flash-frozen in liquid nitrogen and stored in a freezer set to maintain -60 to -80C, until sent to the Sponsor. The Sponsor will analyze the liver samples for PFOS and metabolites. 3 002151 Covanc3eM63T29-6-128935 Mitochondrial Analyses. During the Week 4 tissue collections for animals in Groups 1 through 5, liver samples (approximately 1.5 g) were collected and analyzed by the Sponsor for mitochondrial activity. Bromodeoxyuridine Immunohistochemistry. Seven days before the Week 53 interim sacrifice, osmotic pumps (ALZET Model 2ML1) were surgically implanted from five animals/sex/group from Groups 1 and 5. The osmotic pumps were preloaded with approximately 2 mL of bromodeoxyuridine (BrdU) at a concentration of 20 mg/mL. The animals were anesthetized by administration of acepromazine-ketamine-xylazine, and one pump/animal was aseptically inserted subcutaneously (dorsal surface). The incision was closed with wound clips, and the animals were monitored during clinical observations until the time of sacrifice to ensure that there are no clinical signs of infection. One Group 5 male implanted with osmotic pump was sacrificed before the Week 53 sacrifice. At the Week 53 sacrifice, BrdU immunohistochemistry was performed by PAI on the livers and duodnums from the five animals/sex/group from Groups 1 and 5 that received BrdU. In addition, sections of the livers and duodnums from these animals were stained with hematoxylin and eosin and examined microscopically. Results will be provided for inclusion in the final report. Results Clinical Observations and Survival. Adjusted survival data are summarized in Table 1. Clinical observation data are summarized in Table 2. Survival after 53 weeks of treatment was 96.0%, 96.0%, 100%, 94.0%, 96.0%, and 100% for males in Groups 1, 2, 3, 4, 5, and 6, respectively, and 100%, 94.0%, 94.0%, 96.0%, 98.0%, and 98.0% for females in Groups 1, 2, 3, ,4 ,5 , and 6, respectively. There were no apparent test material-related clinical observations noted through Week 53. Body Weights. Body weight and body weight change data are summarized in Tables 3 and 4. Males given 20.0 ppm had significantly lower mean body weights compared to those of animals given the control material during Weeks 9 through 53, and females given 20.0 ppm had significantly lower body weights compared to those of animals given the control material during Weeks 3 through 53. Mean body weights for males and females were similar in all the other treated groups compared to those of animals given the control 4 002152 Covanc3eM63T29-6-128935 material. Males and females given 20.0 ppm gained less weight during the overall period from Weeks 1 through 53; the differences were statistically significant for the females. Animals at lower dose levels also had occasional statistically significant decreases in body weight gain; however, these occurrences were inconsistent over time between sexes and were not clearly dose related. Food Consumption. Food consumption data are summarized in Table 5. Although not always statistically significant, males given 20.0 ppm tended to consume less food during Weeks 1 through 24. Food consumption was similar for males given 20.0 ppm compared to those of animals given the control material during Weeks 28 through 52. Statistically significantly lower food consumption was noted for females given 20.0 ppm during Weeks 2 through 44. Food consumption for males and females were similar in all the other treated groups compared to those of animals given the control material. Test Material Consumption. Test material consumption data are summarized in Table 6. Animals were fed diets intended to provide 0,0.5, 2.0, 5.0, 20.0 ppm. The amount of test material consumed by animals on a mg/kg of body weight/day basis was as follows: Target(Dppomse) Levels 02..50 5.0 2200..00 Ach(miegv/ekdg Dboosdey Lweevieglhst/-dRaya)nge Males Females 00..007117--00..025276 00..711744--20..250750 0.732-2.336 00..009252--00..201532 01..203679--02..515499 1.047-2.160 Clinical and Anatomic Pathology. Hematology, clinical chemistry, urinalysis, and urine chemistry data are summarized in Tables 7 through 22. Terminal body weights, absolute organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios are summarized in Tables 23 and 24. Incidences of macroscopic and microscopic observations are summarized in Tables 25 through 29. The Pathology Report contains a discussion of the data. 5 002153 _C_o_v_a_n_c3eM63T2-96-219853 Dose Analyses. Results of the homogeneity, stability, and dose preparation analyses are in Tables 30 through 32. 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 in the analytical method for measuring (PFOS; T-6295). Mean values of the homogeneity analyses for the mix done on March 18, 1998, ranged from 119-135%, and 107-118% of the theoretical concentrations for the diets containing 0.5 and 20 ppm (PFOS; T-6295), respectively. Mean values of the homogeneity analyses for the mix done on April 16, 1998, ranged from 96.2-122%, 98.5-107%, 97.6-101%, and 90.0-101% of the theoretical concentrations for the diet containing 0.5, 2, 5, and 20 ppm (PFOS; T-6295), respectively. Mean values of the homogeneity analyses for the mix done on April 22, 1998, ranged from 93.5-103% of the theoretical concentrations for the diet containing 20 ppm (PFOS; T-6295). Mean values of the homogeneity analyses for the mix done on June 18, 1998, ranged from 91.0-175%, 111-130%, 99.6-102%, and 90.5-97.0% of the theoretical concentrations for the diet containing 0.5, 2, 5, and 20 ppm (PFOS; T-6295). 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. Stability analyses were conducted prestudy in an attempt to resolve issues related to the inherent variability and lack of sufficient sensitivity at levels in the analytical method for measuring (PFOS; T-6295). Results of stability analyses for the mix conducted on March 18, 1998, of samples stored for 28 days at room temperature indicated that the mean concentrations were 78.8 %, 76.7%, 79.8% and 88.1% of the initial concentrations of 0.5, 1, 2, and 20 ppm, respectively. Results of stability analyses for the mix conducted on April 16, 1998, of samples stored for 33 days at room temperature indicated that the mean concentrations were 112.3%, 119.6%, 113.9% and 126.7% of the initial concentrations of 0.5, 1, 2, and 20 ppm, respectively. The mean concentrations of the dose preparation analyses for all levels ranged from 44.4%-276% of the theoretical concentrations (including the reassay and retention sample analyses). Inherent variability and lack of sufficient sensitivity at low levels in the analytical method for measuring (PFOS; T-6295) resulted in homogeneity, stability, and routine analysis data that were in many cases outside of the standard limits of +/- 15%. 6 002154 Covanc3eM63T29-6-128935 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. 7 002155 PATHOLOGY REPORT Week 14 and 53 Interim Sacrifices Covanc3eM63T29-6-128935 SUMMARY The purpose of this study is to assess the chronic toxicity and carcinogenicity of the test material, Perfluorooctane Sulfuric Acid Potassium Salt (PFOS) when administered in the diet to rats for at least 104 weeks. The test material is being administered at dose levels of 0.5, 2.0, 5.0, and 20.0 ppm. This interim report discusses findings through the first 53 weeks of study. Dietary administration of PFOS for approximately 53 weeks was associated with mildly higher urea nitrogen for males and females fed 5.0 or 20.0 ppm; mildly lower glucose for males and females fed 20.0 ppm; mildly to moderately lower cholesterol for males and females fed 20.0 ppm; and mildly higher alanine aminotransferase for males fed 20.0 ppm. None of these effects were considered adverse. There was no effect on hepatic palmitoyl-CoA oxidase activity. Terminal body weights in males and females at Week 14 were comparable between control and treated groups. At the Week 14 interim sacrifice, absolute and relative liver weights were significantly increased in the males given 20.0 ppm. In females given 20.0 ppm, only the liver-to-body weight percentage was significantly increased. Test material-related histomorphologic changes were limited to the liver in the males given 5.0 or 20.0 ppm and in the females given 20.0 ppm. The changes consisted of hypertrophy of hepatocytes in centrilobular areas in males and females, and midzonal to centrilobular hepatocytic vacuolation. The incidence and severity of the changes tended to be greater in the males. At the Week 53 interim sacrifice, terminal body weights were significantly decreased in the females given 20 ppm. In the males, absolute and relative liver weights were increased in the group receiving 20 ppm. In addition, absolute and relative spleen weights were decreased in males given 20 ppm. There were no clear or consistent gross observations at the Week 53 sacrifice that could be attributed to the administration of the test material. At the Week 53 sacrifice, centrilobular hepatocytic hypertrophy and vacuolation was 8 002156 Covanc3eM63T29-6-128935 increased in incidence and severity in the males given 20 ppm. In the females given 20 ppm, generally, only centrilobular hypertrophy was seen, and the change was less severe than that noted in the males. In addition, minimal to slight centrilobular hepatocytic pigment was found in the females given 20 ppm. There were no other histomorphologic changes that could be associated with the administration of the test material. Findings in livers in several unscheduled deaths given 20 ppm resembled those seen in animals sacrificed at Week 53. METHODS Six groups of Crl:CD (SD)IGS BR rats were studied using the following study design. Group______________ NMuamle_b_e_r_o_f_AFneimmaalles D(pipemtarTy-L62ev9e5l)s 1 (Control) 423 (((MMLoiiwdd)-)High) 56 ((HHiigghh Recovery) 70 60 6600 7400 70 60 6600 7400 00.5 2.0 205..00 20.0 During Weeks 4, 14, 27, and 53, blood and urine were collected for hematology, clinical chemistry, urinalysis, and urine chemistry tests from 10 animals/sex in Groups 1 through 5. Five animals/sex in Groups 1 through 5 were sacrificed during Week 4; livers were collected and weighed. A portion of the liver was shipped to the Sponsor for PFOS analysis and mitochondrial activity, a portion was shipped to Pathology Associates International for hepatocellular proliferation rate measurements by proliferation cell nuclear antigen (PCNA), and a third portion was used for determination of palmitoyl-CoA oxidase activity. During Weeks 14 and 53, necropsies were performed on five and 10 animals/sex, respectively, in Groups 1 through 5. At necropsy, macroscopic observations were recorded, organ weights were obtained, and tissues were placed in fixative as specified by the protocol. In addition, liver samples were collected for PFOS analysis (Weeks 14 and 53), hepatocellular proliferation rate measurement [by PCNA at Week 14 and by bromodeoxyuridine (BrdU) immunohistochemistry at Week 53] and palmitoyl-CoA oxidase determination (Week 14). A section of duodenum was also 9 002157 Covance 6329-183 ______ 3MT-6295 collected at Week 53 for BrdU immunohistochemistry. 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 (adrenals, brain, eyes, kidney, liver, mesenteric lymph node, pancreas, spleen, testes, and ovaries) from the animals necropsied during Week 14 and on all tissues from the animals in Groups 1, and 5 that were necropsied during Week 53. In addition, microscopic examinations were done on the tissues from animals that died or were sacrificed due to poor health. 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 Weeks 4,14, 27, and 53. There were relatively few statistically significant or otherwise notable differences for clinical pathology results between the control and treated groups. Those differences that were the most consistent over time were considered to be associated with administration of the test material. These included mildly higher urea nitrogen for males and females fed 5.0 or 20.0 ppm; mildly lower glucose for males and females fed 20.0 ppm; mildly to moderately lower cholesterol for males and females fed 20.0 ppm; and mildly higher alanine aminotransferase for males fed 20.0 ppm. There were no correlative microscopic renal findings for the minor change in urea nitrogen. The findings for alanine-aminotransferase, and possibly for glucose and cholesterol, were likely associated with the histopathological findings of hepatocellular hypertrophy and vacuolation. None of the clinical pathology effects were considered adverse. Of uncertain relationship to the test material were statistically higher urea nitrogen for males fed 2.0 ppm and statistically lower glucose for females fed 2.0 or 5.0 ppm at Week 53. These findings were not as consistent over time as those considered to be effects of the test material, and the magnitudes of these differences were very small. 10 002158 Covanc3eM63T29-6-128935 All other statistically significant differences for clinical pathology results between the control and treated groups were considered incidental. Most of these differences did not affect animals fed the highest dose level, and none of these differences were consistent over time. Anatomical Pathology Week 14, Terminal Body Weight and Organ Weights. Terminal body weights were comparable between control and treated groups. Absolute and relative liver weights were significantly increased in the males given 20.0 ppm. In females given 20.0 ppm, only the liver-to-body weight percentage was significantly increased. The absolute spleen weight was significantly decreased in the females given 20.0 ppm, as was the absolute lung weight in females given 2.0, 5.0, or 20.0 ppm. Spurious, significant increases in left thyroid/parathyroid-to-body weight percentages were seen in females given 5.0 or 20.0 ppm. Macroscopic Observations. There were no macroscopic observations that could be attributed to the administration of the test material. Microscopic Observations. Test material-related histomorphologic changes were limited to the liver in the males given 5.0 or 20.0 ppm and in the females given 20.0 ppm. The changes consisted of hypertrophy of hepatocytes in centrilobular areas and midzonal to centrilobular hepatocytic vacuolation. The incidence and severity of the changes tended to be greater in the males. There were no potentially test material-related lesions in the remaining tissues examined. Week 53 Interim Sacrifice, Body and Organ Weights. In the females, terminal body weights were significantly decreased in the group given 20 ppm. Terminal body weights in the males were comparable between control and treated groups. In the males, absolute and relative liver weights were increased in the group receiving 20 ppm. In addition, absolute and relative spleen weights were decreased in males given 20 ppm. Significantly decreased left thyroid/parathyroid weights were considered to be spurious due to the absence of a contralateral effect. 11 002159 Covanc3eM63T29-6-128935 In view of the significant decreased in body weight in females given 20ppm, significant increases in organ-to-body weight percentages for brain, kidney, liver, and spleen may be of no toxicological importance. Decreased absolute weights in the left adrenal gland and bilateral adrenal-to-brain weight ratios may also represent changes secondary to the body weight loss. Macroscopic Observations. There were no clear or consistent gross observations at the Week 53 sacrifice that could be attributed to the administration of the test material. Microscopic Observations. Centrilobular hepatocytic hypertrophy and vacuolation was increased in incidence and severity in the males given 20 ppm. In the females given 20 ppm, generally, only centrilobular hypertrophy was seen, and the change was less severe than that noted in the males. In addition, minimal to slight Centrilobular hepatocytic pigment was found in the females given 20 ppm. There were no other histomorphologic changes that could be associated with the administration of the test material. Unscheduled Deaths Through Week 53 Large, mottled, or diffusely dark livers were noted in 2/3 males and 1/1 females given 20ppm. There were no other gross observations that could be attributed to the administration of the test material. Microscopically, several animals given 20 ppm exhibited liver changes that were similar or related to those seen at the Week 53 Interim Sacrifice. Robert L. Hah, DVM, PhD D(CilpilnoimcaaltPe,atAhoClVogPy) DDRiiicpphllooammrdaaDttee.,, AAAlCBsaVTkPer, DVM, MS Date Date 12 002160 002161 TABLE 1 Summary of Adjusted Survival Data Covance 6329-183 3M T-6295 GROUP AND DOSE LEVEL (PPM) 0 2 .500 3 2 4 5 5 20 6 20 WEEK: START 70/70 60/60 60/60 60/60 70/70 40/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 1 70/70 60/60 60/60 60/60 70/70 40/40 2 70/70 60/60 60/60 60/60 70/70 40/40 3 70/70 60/60 60/60 60/60 70/70 40/40 45 MALE 65/65 65/65 55/55 55/55 55/55 55/55 55/55 55/55 65/65 65/65 40/40 40/40 6 65/65 55/55 55/55 55/55 65/65 40/40 7 65/65 55/55 55/55 55/55 65/65 40/40 8 65/65 55/55 55/55 55/55 65/65 40/40 9 65/65 55/55 55/55 55/55 65/65 40/40 PAGE: 1 10 11 65/65 65/65 55/55 55/55 55/55 55/55 55/55 55/55 65/65 65/65 40/40 40/40 002162 TABLE 1 Summary of Adjusted Survival Data Covance 6329-183 3M T-6295 GROUP AND DOSE LEVEL (PPM) 1 0 2 .500 3 2 4 5 5 20 6 20 WEEK: 12 65/65 55/55 55/55 55/55 65/65 40/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 13 65/65 55/55 55/55 55/55 65/65 40/40 14 60/60 50/50 50/50 50/50 60/60 40/40 15 60/60 50/50 50/50 50/50 60/60 40/40 16 17 MALE 60/60 60/60 50/50 50/50 50/50 50/50 50/50 50/50 60/60 60/60 40/40 40/40 18 60/60 50/50 50/50 50/50 60/60 40/40 19 60/60 49/50 50/50 50/50 60/60 40/40 20 60/60 49/50 50/50 50/50 60/60 40/40 21 60/60 49/50 50/50 50/50 60/60 40/40 PAGE: 2 22 23 60/60 59/60 49/50 49/50 50/50 50/50 50/50 50/50 60/60 60/60 40/40 40/40 002163 TABLE 1 Summary of Adjusted Survival Data Covance 6329-183 3M T-6295 GROUP AND DOSE LEVEL (PPM) x 0 2 .500 3 2 4 5 5 20 6 20 WEEK: 24 59/60 49/50 50/50 50/50 60/60 40/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 25 59/60 49/50 50/50 50/50 60/60 40/40 26 59/60 49/50 50/50 50/50 60/60 40/40 27 59/60 49/50 50/50 50/50 60/60 40/40 28 29 MALE 59/60 59/60 49/50 49/50 50/50 50/50 50/50 50/50 60/60 60/60 40/40 40/40 30 59/60 49/50 50/50 50/50 60/60 40/40 31 59/60 49/50 50/50 50/50 60/60 40/40 32 59/60 49/50 50/50 50/50 60/60 40/40 33 59/60 49/50 50/50 50/50 60/60 40/40 PAGE: 3 34 35 59/60 59/60 49/50 49/50 50/50 50/50 50/50 50/50 60/60 60/60 40/40 40/40 002164 TABLE 1 Summary of Adjusted Survival Data Covance 6329-183 3M T-6295 GROUP AND DOSE LEVEL (PPM) X 0 2 .500 3 2 4 5 5 20 6 20 WEEK: 36 59/60 49/50 50/50 50/50 59/60 40/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 37 59/60 49/50 50/50 50/50 59/60 40/40 38 59/60 49/50 50/50 50/50 59/60 40/40 39 59/60 48/50 50/50 50/50 59/60 40/40 40 41 MALE 59/60 59/60 48/50 48/50 50/50 50/50 50/50 50/50 59/60 59/60 40/40 40/40 42 59/60 48/50 50/50 50/50 59/60 40/40 43 59/60 48/50 50/50 50/50 59/60 40/40 44 59/60 48/50 50/50 50/50 59/60 40/40 45 59/60 48/50 50/50 50/50 59/60 40/40 PAGE: 4 46 47 59/60 48/50 50/50 50/50 59/60 40/40 58/60 48/50 50/50 50/50 58/60 40/40 TABLE 1 Summary of Adjusted Survival Data GROUP AND DOSE LEVEL (PPM) 1 0 2 .500 3 2 4 5 5 20 6 20 WEEK: 48 58/60 48/50 50/50 50/50 58/60 40/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 49 58/60 48/50 50/50 50/50 58/60 40/40 50 58/60 48/50 50/50 50/50 58/60 40/40 51 58/60 48/50 50/50 50/50 58/60 40/40 52 53 MALE 58/60 48/50 48/50 48/50 50/50 50/50 49/50 47/50 57/60 48/51 40/40 40/40 Covance 6329-183 3M T-6295 PAGE: 5 002165 002166 TABLE 1 Summary of Adjusted Survival Data Covance 6329-183 3M T-6295 GROUP AND DOSE LEVEL (PPM) 0 2 .500 3 2 4 5 5 20 6 20 WEEK : START 70/70 60/60 60/60 60/60 70/70 40/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 1 70/70 60/60 60/60 60/60 70/70 40/40 2 70/70 60/60 60/60 60/60 70/70 40/40 3 70/70 60/60 60/60 60/60 70/70 40/40 45 FEMALE 65/65 65/65 55/55 55/55 55/55 55/55 55/55 55/55 65/65 65/65 40/40 40/40 6 65/65 55/55 55/55 55/55 65/65 40/40 7 65/65 55/55 55/55 55/55 65/65 40/40 8 65/65 55/55 55/55 55/55 65/65 40/40 9 65/65 55/55 54/55 55/55 65/65 40/40 PAGE: 6 10 11 65/65 65/65 55/55 55/55 54/55 54/55 55/55 55/55 65/65 65/65 40/40 40/40 002167 TABLE 1 Summary of Adjusted Survival Data Covance 6329-183 3M T-6295 GROUP AND DOSE LEVEL (PPM) 0 2 .500 3 2 4 5 5 20 6 20 WEEK: 12 65/65 55/55 54/55 55/55 65/65 40/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 13 65/65 55/55 54/55 55/55 65/65 40/40 14 60/60 50/50 49/50 50/50 60/60 40/40 15 60/60 50/50 49/50 50/50 60/60 40/40 16 17 FEMALE 60/60 60/60 50/50 50/50 49/50 49/50 50/50 50/50 60/60 60/60 40/40 40/40 18 60/60 50/50 49/50 50/50 60/60 40/40 19 60/60 50/50 49/50 50/50 60/60 40/40 20 60/60 50/50 49/50 50/50 60/60 40/40 21 60/60 50/50 49/50 50/50 60/60 40/40 PAGE: 7 22 23 60/60 60/60 50/50 50/50 49/50 49/50 50/50 50/50 60/60 60/60 40/40 40/40 00216S TABLE 1 Summary of Adjusted Survival Data Covance 6329-183 3M T-6295 GROUP AND DOSE LEVEL (PPM) x 0 2 .500 3 2 4 5 5 20 6 20 WEEK: 24 60/60 50/50 49/50 50/50 60/60 40/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 25 60/60 50/50 49/50 50/50 60/60 40/40 26 60/60 50/50 49/50 50/50 60/60 40/40 27 60/60 50/50 49/50 50/50 60/60 40/40 28 29 FEMALE 60/60 60/60 50/50 50/50 49/50 49/50 50/50 50/50 60/60 60/60 40/40 40/40 30 60/60 50/50 49/50 50/50 60/60 40/40 31 60/60 50/50 49/50 49/50 60/60 40/40 32 60/60 50/50 49/50 49/50 60/60 40/40 33 60/60 49/50 49/50 49/50 60/60 40/40 PAGE: 8 34 35 60/60 49/50 49/50 49/50 60/60 40/40 60/60 49/50 49/50 49/50 60/60 40/40 002169 TABLE 1 Summary of Adjusted Survival Data Covance 6329-183 3M T-6295 GROUP AND DOSE LEVEL (PPM) 0 2 .500 3 2 4 5 5 20 6 20 WEEK: 36 60/60 49/50 49/50 49/50 60/60 40/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 37 60/60 49/50 49/50 49/50 60/60 40/40 38 60/60 49/50 49/50 49/50 60/60 40/40 39 60/60 49/50 49/50 49/50 59/60 40/40 40 41 FEMALE 60/60 60/60 49/50 48/50 49/50 49/50 49/50 49/50 59/60 59/60 40/40 39/40 42 60/60 48/50 49/50 49/50 59/60 39/40 43 60/60 48/50 49/50 49/50 59/60 39/40 44 60/60 48/50 49/50 49/50 59/60 39/40 45 60/60 48/50 48/50 49/50 59/60 39/40 PAGE: 9 46 47 60/60 60/60 48/50 48/50 47/50 47/50 49/50 49/50 59/60 59/60 39/40 39/40 TABLE 1 Summary of Adjusted Survival Data GROUP AND DOSE LEVEL (PPM) 0 2 .500 3 2 4 5 5 20 6 20 WEEK: 48 60/60 48/50 47/50 49/50 59/60 39/40 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS 49 60/60 48/50 47/50 49/50 59/60 39/40 50 60/60 47/50 47/50 49/50 59/60 39/40 51 60/60 47/50 47/50 49/50 59/60 39/40 52 53 FEMALE 60/60 50/50 47/50 47/50 47/50 47/50 48/50 48/50 59/60 49/50 39/40 39/40 Covance 6329-183 3M T-6295 PAGE: 10 002170 DAYS 1-371 CATEGORY KEYWORD QUALIFIER '* TOP OF LIST *** PEARANCE BENT TAIL CONVULSIONS HEAD TILT LEFT RIGHT HUNCHED LIMITED USE LIMB-HIND-LEFT LIMBS-HIND MALOCCLUSION MISSING TAIL-DISTAL TEETH PARALYSIS LIMBS-HIND SWOLLEN LIMB-HIND-LEFT MOUTH NOSE PAW-HIND-LEFT TAIL-DISTAL VENTRAL-ABDOMINAL TESTES THIN Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX GROUP DOSE NUMBER: NUMBER OF ANIMALS AFFECTED ----------- MALE----------- 12 3 4 56 0 0.5 2 5 20 20 70 60 60 60 70 40 010001 000000 000000 000000 000100 000010 000020 664 687 000000 12 0 1 2 1 010000 000010 010000 000001 000000 000000 000100 001000 200210 w Covance3M63T29-6-128935 PAGE: 1 002171 DAYS 1-311 CATEGORY KEYWORD QUALIFIER BEHAVIOR ATAXIC <UNSPECIFIED> CIRCLING RIGHT HYPOACTIVE <UNSPECIFIED> MILD SENSITIVE TO TOUCH COLD TO TOUCH LIMBS-HIND ENTIRE BODY DISCHARGE GENITAL RED IN COLOR CLEAR ORAL MILD NASAL RED IN COLOR UNKNOWN RED IN COLOR EXCRETION FEW FECES Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- 11ALE-123456 0 0.5 2 5 20 20 70 60 60 60 70 40 100000 000000 000100 000000 000100 010000 00010 0 4 0113 1 000100 101001 002000 11032 0 Covance3M63T29-6-128935 PAGE: 2 002172 DAYS 1-371 CATEGORY KEYWORD QUALIFIER EXCRETION NO FECES NONFORMED FECES EYES CLEAR DISCHARGE EYE-LEFT RED DISCHARGE EYE-LEFT EYE-RIGHT EYES SCAB EYE-RIGHT SQUINTED PERI-ORBITAL RESPIRATION AUDIBLE IRREGULAR LABORED SKIN & PELAGE ALOPECIA BROWN HAIR COAT SCROTUM Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED --- -- MALE-12345 0 0.5 2 5 20 6 20 70 60 60 60 70 40 000000 000102 110000 003100 001212 100100 020000 000000 121100 100000 020100 000000 100000 Covance 6329-183 3M T-6295 oTocr>*i. PAGE: 3 DAYS 1-371 CATEGORY KEYWORD QUALIFIER SKIN & PELAGE BLACK SKIN DORSAL PALE ENTIRE BODY RED HAIR COAT HEAD-ENTIRE HEAD-CRANIAL HEAD-MAXILLARY-LEFT HEAD-MAXILLARY-RIGHT ROUGH HAIR COAT SORE/SCAB AXILLARY REGION-LEFT DORSAL DORSAL-CERVICAL-LEFT DORSAL-CERVICAL-RIGHT DORSAL-THORACIC-LEFT DORSAL-THORACIC-RIGHT EAR-RIGHT HEAD-CRANIAL HEAD-MAXILLARY-LEFT HEAD-MAXILLARY-RIGHT LATERAL-CERVICAL-RIGHT LIMB-FRONT-RIGHT MOUTH PAW-HIND-LEFT Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP : DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- :4ALE-12 34 5 6 0 0.5 2 5 20 20 70 60 60 60 70 40 000000 000100 011000 000000 000100 000100 200110 000000 000001 000010 000000 000010 000000 000001 000000 000010 000000 000000 000110 000001 000001 Covance3M63T29-6-128935 PAGE: 4 002174 DAYS 1-371 CATEGORY KEYWORD QUALIFIER SKIN & PELAGE SORE/SCAB SHOULDER-RIGHT TAIL VENTRAL-ABDOMINAL VENTRAL-ABDOMINAL-LEFT VENTRAL-ABDOMINAL-RIGHT VENTRAL-CERVICAL VENTRAL-CERVICAL-LEFT VENTRAL-CERVICAL-RIGHT YELLOW HAIR COAT MASS (ES) AXILLARY REGION-LEFT WEEK 37 WEEK 38 WEEK 39 WEEK 41 WEEK 44 WEEK 45 WEEK 46 WEEK 48 WEEK 50 Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- 11ALE-- 123456 0 0.5 2 5 20 20 70 60 60 60 70 40 100000 000000 101110 010120 010020 020000 000000 000000 100000 000000 000000 010000 000000 000000 000000 000000 000000 000000 c o v a n c e 3M6 3T2 9-6-128935 PAGE: 5 002175 DAYS 1-371 CATEGORY KEYWORD QUALIFIER WART LIKE LESION(S) DORSAL-CERVICAL WEEK 7 EAR-RIGHT WEEK 41 HEAD-MAXILLARY-LEFT WEEK 19 WEEK 31 MOUTH WEEK 46 WEEK 47 NOSE WEEK 46 VENTRAL-ABDOMINAL WEEK 40 VENTRAL-THORACIC-LEFT WEEK 46 SURGERY PERFORMED BY JOHN VAN BERKUM KATHY EWERS PATTIE MURPHY Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- MALE--12 3 4 5 6 0 0.5 2 5 20 20 70 60 60 60 70 40 000000 000001 001000 010000 000000 000000 000000 000100 001000 100020 300020 100010 Covance3M63T29-6-128935 PAGE: 10 002176 DAYS 1-371 CATEGORY KEYWORD QUALIFIER ANTIBIOTIC ADMINISTERED 0.5 ML * * * END OF LIST *** Table 2 Summary of Clinical observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP : DOSE: NUMBER: in o NUMBER OF ANIMALS AFFECTED -- MALE-- 1234 56 0 2 5 20 20 70 60 60 60 70 40 500050 Covance 6329-183 3M T-6295 PAGE: 11 002177 DAYS 1-371 CATEGORY KEYWORD QUALIFIER *** TOP OF LIST *** APPEARANCE BENT TAIL CONVULSIONS HEAD TILT LEFT RIGHT HUNCHED LIMITED USE LIMB-HIND-LEFT LIMBS-HIND MALOCCLUSION MISSING TAIL-DISTAL TEETH PARALYSIS LIMBS-HIND SWOLLEN LIMB-HIND-LEFT MOUTH NOSE PAW-HIND-LEFT TAIL-DISTAL VENTRAL-ABDOMINAL TESTES THIN Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED --FEMALE-- 1234 56 0 0.5 2 5 20 20 70 60 60 60 70 40 000000 000011 100000 001000 001001 100000 000000 12 9 6 6 5 7 001000 121121 000000 000000 010000 000100 100000 001 000 000000 000000 111011 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 12 002178 DAYS 1-371 CATEGORY KEYWORD QUALIFIER BEHAVIOR ATAXIC <UNSPECIFIED> CIRCLING RIGHT HYPOACTIVE <UNSPECIFIED> MILD SENSITIVE TO TOUCH COLD TO TOUCH LIMBS-HIND ENTIRE BODY DISCHARGE GENITAL RED IN COLOR CLEAR ORAL MILD NASAL RED IN COLOR UNKNOWN RED IN COLOR EXCRETION FEW FECES Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED --- -- FEMALE-- 12345 0 0.5 2 5 20 6 20 70 60 60 60 70 40 001000 100000 001000 001000 100000 000000 000000 000001 000000 210000 000000 211110 Covance3M63T29-6-128935 PAGE: 13 002179 DAYS 1-371 CATEGORY KEYWORD QUALIFIER EXCRETION NO FECES NONFORMED FECES EYES CLEAR DISCHARGE EYE-LEFT RED DISCHARGE EYE-LEFT EYE-RIGHT EYES SCAB EYE-RIGHT SQUINTED PERI-ORBITAL RESPIRATION AUDIBLE IRREGULAR LABORED SKIN & PELAGE ALOPECIA BROWN HAIR COAT SCROTUM Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP : DOSE : NUMBER: in o NUMBER OF ANIMALS AFFECTED --- -- FEMALE-123456 0 2 5 20 20 70 60 60 60 70 40 001001 200000 000000 000011 010201 000001 000000 001000 002000 000000 000000 200000 000000 C ovance 3M6 3T2 9-6-128935 PAGE: 14 002180 DAYS 1-371 CATEGORY KEYWORD QUALIFIER SKIN & PELAGE BLACK SKIN DORSAL PALE ENTIRE BODY RED HAIR COAT HEAD-ENTIRE HEAD-CRANIAL HEAD-MAXILLARY-LEFT HEAD-MAXILLARY-RIGHT ROUGH HAIR COAT SORE/SCAB AXILLARY REGION-LEFT DORSAL DORSAL-CERVICAL-LEFT DORSAL-CERVICAL-RIGHT DORSAL-THORACIC-LEFT DORSAL-THORACIC-RIGHT EAR-RIGHT HEAD-CRANIAL HEAD-MAXILLARY-LEFT HEAD-MAXILLARY-RIGHT LATERAL-CERVICAL-RIGHT LIMB-FRONT-RIGHT MOUTH PAW-HIND-LEFT Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: in o NUMBER OF ANIMALS AFFECTED --FEMALE-12 34 5 6 0 2 5 20 20 70 60 60 60 70 40 010000 011010 103001 010000 000000 000000 200010 010000 010000 000000 001000 000000 200000 000000 001000 000000 001010 010000 000000 100011 100000 C o v a n ce 3M6 3T2 9-6- 128935 PAGE: 15 002181 DAYS 1-371 CATEGORY KEYWORD QUALIFIER SKIN A PELAGE SORE/SCAB SHOULDER-RIGHT TAIL VENTRAL-ABDOMINAL VENTRAL-ABDOMINAL- LEFT VENTRAL-ABDOMINAL-RIGHT VENTRAL-CERVICAL VENTRAL-CERVICAL-LEFT VENTRAL-CERVICAL-RIGHT YELLOW HAIR COAT MASS(ES) AXILLARY REGION-LEFT WEEK 37 WEEK 38 WEEK 39 WEEK 41 WEEK 44 WEEK 45 WEEK 46 WEEK 48 WEEK 50 Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- FE*ALE-123 4 5 6 0 0.5 2 5 20 20 70 60 60 60 70 40 0 00 00 0 001000 000010 010000 0 00 00 0 000000 010000 0 00 01 0 102 010 001000 010000 000000 000100 001000 011000 1 00 00 0 300000 02 0 00 1 C o v a n ce 3M6 3T2 9- 6- 128935 PAGE: 16 002182 DAYS 1-371 CATEGORY KEYWORD QUALIFIER MASS(ES) AXILLARY REGION-LEFT WEEK 51 AXILLARY REGION-RIGHT WEEK 36 WEEK 37 WEEK 45 WEEK 46 WEEK 48 WEEK 53 DORSAL WEEK 11 WEEK 29 WEEK 49 WEEK 51 WEEK 53 DORSAL-CERVICAL-LEFT WEEK 25 EAR-LEFT WEEK 48 EAR-RIGHT WEEK 47 HEAD-MAXILLARY-RIGHT WEEK 43 INGUINAL REGION-LEFT WEEK 43 Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED --FEMALE-- 123456 0 0.5 2 5 20 20 70 60 60 60 70 40 001000 01 00 00 000000 001000 100000 100000 002010 010000 010000 000000 000000 000000 000000 000000 000000 100000 001000 Covance3M63T29-6-128935 PAGE: 17 002183 DAYS 1-371 CATEGORY KEYWORD QUALIFIER MASS(ES) INGUINAL REGION-LEFT WEEK 46 WEEK 48 INGUINAL REGION-RIGHT WEEK 28 WEEK 43 WEEK 50 LIMB-FRONT-LEFT WEEK 45 LIMB-FRONT-RIGHT WEEK 47 WEEK 51 LIMB-HIND-RIGHT WEEK 47 SHOULDER-LEFT WEEK 48 SHOULDER-RIGHT WEEK 50 TAIL WEEK 49 VENTRAL-ABDOMINAL WEEK 15 WEEK 27 WEEK 29 WEEK 30 Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -FEMALE-12 34 5 6 0 0.5 2 5 20 20 70 60 60 60 70 40 001000 001001 000000 001000 100000 000100 000000 000000 000100 000010 000000 000000 100000 000000 000000 100000 C o v a n ce 3M6 3T2 9-6- 128935 PAGE: 18 002184 DAYS 1-371 CATEGORY KEYWORD QUALIFIER MASS(ES) VENTRAL-ABDOMINAL WEEK 36 WEEK 39 WEEK 41 WEEK 43 WEEK 45 WEEK 47 WEEK 53 VENTRAL-ABDOMINAL-LEFT WEEK 18 WEEK 30 WEEK 33 WEEK 34 WEEK 40 WEEK 42 WEEK 43 WEEK 44 WEEK 45 WEEK 46 WEEK 49 WEEK 50 WEEK 51 VENTRAL-ABDOMINAL-RIGHT WEEK 25 WEEK 38 Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP : DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED --FEMALE-- 12 34 5 6 0 0.5 2 5 20 20 70 60 60 60 70 40 100000 000000 200000 001000 000000 100000 001000 010000 00 0 00 0 001000 100000 0 0 0 00 0 000100 010000 000000 000000 000000 00 0 01 0 001000 001000 110000 100000 C o v a n ce 3M6 3T2 9-6- 128935 PAGE: 19 002185 DAYS 1-371 CATEGORY KEYWORD QUALIFIER MASS(ES) VENTRAL-ABDOMINAL-RIGHT WEEK 40 WEEK 44 WEEK 47 WEEK 48 WEEK 50 WEEK 53 VENTRAL-CERVICAL WEEK 37 WEEK 45 WEEK 53 VENTRAL-CERVICAL-LEFT WEEK 3 WEEK 21 WEEK 42 WEEK 47 VENTRAL-CERVICAL-RIGHT WEEK 47 VENTRAL-THORACIC WEEK 45 VENTRAL-THORACIC-LEFT WEEK 25 WEEK 47 VENTRAL-THORACIC -RIGHT WEEK 10 Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- FEMALE-- 12 34 5 6 0 0.5 2 5 20 20 70 60 60 60 70 40 001000 000000 010100 110000 010000 100010 000000 000001 0 02 01 0 010000 010000 000100 100000 010000 100000 010000 000010 000001 C o v a n ce 3M6 3T2 9-6- 128935 PAGE: 20 002186 DAYS 1-371 CATEGORY KEYWORD QUALIFIER WART LIKE LESION (S) DORSAL-CERVICAL WEEK 7 EAR-RIGHT WEEK 41 HEAD-MAXILLARY-LEFT WEEK 19 WEEK 31 MOUTH WEEK 46 WEEK 47 NOSE WEEK 46 VENTRAL-ABDOMINAL WEEK 40 VENTRAL-THORACIC-LEFT WEEK 46 SURGERY PERFORMED BY JOHN VAN BERKUM KATHY EWERS PATTIE MURPHY Table 2 Summary of Clinical Observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- FEALE-i23456 0 0.5 2 5 20 20 70 60 60 60 70 40 001000 000000 000000 000000 200000 000010 010000 000000 000000 200020 000010 300020 C o v a n ce 3M6 3T2 9-6- 128935 PAGE: 21 002187 DAYS 1-371 CATEGORY KEYWORD QUALIFIER ANTIBIOTIC ADMINISTERED 0.5 ML *** END OF LIST *** Table 2 Summary of Clinical observations 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS SEX: GROUP: DOSE: NUMBER: NUMBER OF ANIMALS AFFECTED -- FEMALE-- 123456 0 0.5 2 5 20 20 70 60 60 60 70 40 500050 Covance 6329-183 3M T-6295 PAGE: 22 002188 Table 3 Summary of Body Weight Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS `DRAFT* SEX: -------------------------------- MALE- GROUP : 1 2 3 4 5 6 DOSE: 0 0.5 2 5 20 20 WEEK UNITS : PPM PPM PPM PPM PPM PPM 1N 70 MEAN 179 S.D. 18.6 2N 70 MEAN 237 S.D. 21.8 3N 70 MEAN 287 S.D. 25.0 4N 70 MEAN 334 S.D. 27.6 5N 65 MEAN 367 S.D. 31.4 6N 65 MEAN 399 S.D. 34.3 7N 65 MEAN 419 S.D. 35.1 60 178 18.7 60 237 20.2 60 290 21.4 60 333 23.9 55 370 27.1 55 402 30.8 55 428 33.3 60 179 19.0 60 237 21.5 60 286 23.0 60 328 25.4 55 367 28.4 55 397 30.3 55 418 31.8 60 179 19.2 60 23 6 20.5 60 290 22.8 60 333 24.3 55 367 27.9 55 399 30.4 55 425 32.2 70 178 18.7 70 234 20.2 70 285 23.2 70 323 25.0 65 3 61 28.1 65 390 30.2 65 413 32.7 40 178 19.0 40 231 22.0 40 286 25.2 40 326 28.0 40 363 31.4 40 394 34.6 40 415 36.8 Covance 6329-183 3M T-6295 PAGE: 1 002189 GROUP: DOSE: WEEK 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 65 448 37.8 65 464 41.6 65 481 43.1 65 499 45.2 65 509 46.8 65 517 48.0 65 528 51.1 Table 3 Summary of Body Weight Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* 2 0.5 PPM 55 450 35.7 55 463 37.7 55 483 39.8 55 502 42.1 55 512 43.9 55 518 45.6 55 534 47.3 3 2 PPM 55 443 35.9 55 450 38.2 55 473 40.7 55 479* 42.6 55 494 44.3 55 508 47.5 55 517 49.4 4 5 PPM 55 448 35.1 55 466 36.8 55 479 36.9 55 494 38.5 55 507 40.4 55 514 42.5 55 527 44.4 5 20 PPM 65 432 34.2 65 446* 36.4 65 465 37.2 65 474* 38.5 65 485* 41.5 65 493* 43.2 65 504* 46.1 6 20 PPM 40 43 6 40.8 40 446 41.0 40 466 42.2 40 473* 45.2 40 483* 46.4 40 491* 49.1 40 501* 50.4 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 2 06TZ00 SEX: GROUP: DOSE: WEEK UNITS: 1 0 PPM 15 N 60 MEAN 535 S.D. 51.9 16 N 60 MEAN 549 S.D. 53.5 17 N 60 MEAN 556 S.D. 55.4 21 N 60 MEAN 580 S.D. 62.1 25 N 59 MEAN 609 S.D. 67.8 29 N 59 MEAN 644 S.D. 76.0 33 N 59 MEAN 669 S.D. 79.5 Table 3 Summary of Body Weight Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* --------- MAIjE ------------------------------- 23 4 5 0.5 2 5 20 PPM PPM PPM PPM 6 20 PPM 50 542 48.2 50 553 49.9 50 559 50.5 49 594 57.5 49 621 63.0 49 654 66.6 49 683 71.0 50 531 49.0 50 542 50.0 50 551 51.0 50 582 57.5 50 611 61.0 50 640 67.4 50 666 70.4 50 535 45.5 50 550 46.5 50 557 47.8 50 581 53.2 50 604 56.7 50 632 62.5 50 653 68.8 60 513* 47.5 60 523* 49.3 60 526* 49.8 60 546* 57.2 60 567* 62.9 60 595* 69.0 60 619* 76.6 40 510* 51. 40 517* 52. 40 521* 52. 40 544* 59. 40 566* 65. 40 595* 69. 40 620* 75. Covan ee3M63T29-6-128935 PAGE: 3 I 002191 Table 3 Summary of Body Weight Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* SEX: -------------------------------- MALE' GROUP: 1 2 3 4 5 6 DOSE: 0 0.5 2 5 20 20 WEEK UNITS : PPM PPM PPM PPM PPM PPM 37 N 59 MEAN 691 S.D. 83.5 41 N 59 MEAN 699 S.D. 87.9 45 N 59 MEAN 715 S.D. 95.8 49 N 58 MEAN 736 S.D. 97.2 53 N 58 MEAN 749 S.D. 103.5 49 700 77.8 48 716 81.8 48 735 87.8 48 759 89.5 48 770 91.7 50 687 73.8 50 702 78.2 50 721 80.4 50 740 83.5 50 753 86.2 50 676 73.6 50 690 77.6 50 709 82.3 50 726 88.9 48 742 97.1 59 644* 84.7 59 663 92.5 59 67 6 100.7 58 699 108.3 57 713 115.0 40 644* 81.8 40 657 89.6 40 674 97.6 40 697 104.3 40 712 109.2 Covance3M63T29--6128935 PAGE: 4 SEX: GROUP: DOSE: WEEK UNITS: 1 0 PPM 1N 70 MEAN 154 S.D. 11.1 2N 70 MEAN 183 S.D. 14.6 3N 70 MEAN 207 S.D. 18.6 4N 70 MEAN 224 S.D. 22.1 5N 65 MEAN 237 S.D. 23.6 6N 65 MEAN 248 S.D. 25.3 7N 65 MEAN 254 S.D. 27.7 Table 3 Summary of Body Weight Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* -------- FEMALE- 23456 0.5 2 5 20 20 PPM PPM PPM PPM PPM 60 154 10.4 60 180 15.0 60 204 17.4 60 222 21.2 55 236 22.9 55 250 25.0 55 257 27.1 60 155 10.0 60 176 14.2 60 199* 15.7 60 217 18.9 55 232 20.1 55 245 21.6 55 251 20.0 60 154 10.1 60 180 13.2 60 204 15.5 60 218 19.1 55 232 20.0 55 244 21.1 55 250 21.7 70 153 11.1 70 177 13.5 70 199* 16.2 70 215* 17.4 65 224* 17.4 65 233* 19.6 65 23 6* 20.1 40 155 11. 40 178 14. 40 198* 15. 40 214 18. 40 227 19. 40 235* 19. 40 240* 18. Covane3M6 3T2 9- 6- 128935 PAGE: 5 002193 Table 3 Summary of Body Weight Bata (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* SEX: ------------------------------- FEMALE GROUP: 1 2 3 4 5 6 DOSE: 0 0.5 2 5 20 20 WEEK UNITS: PPM PPM PPM PPM PPM PPM 8N 65 MEAN 266 S.D. 30.0 9N 65 MEAN 268 S.D. 31.4 10 N 65 MEAN 279 S.D. 33.5 11 N 65 MEAN 281 S.D. 33.8 12 N 65 MEAN 290 S.D. 37.0 13 N 65 MEAN 295 S.D. 38.9 14 N 65 MEAN 300 S.D. 40.1 55 269 28.1 55 273 30.2 55 283 31.7 55 291 33.1 55 292 34.5 55 296 35.3 55 303 37.6 55 262 23.0 55 263 21.7 54 271 23.7 54 277 23.8 54 278 23.6 54 284 24.4 54 292 24.5 55 263 24.4 55 264 25.3 55 275 27.2 55 277 25.8 55 279 27.5 55 285 29.1 55 292 31.7 65 247* 20.2 65 245* 22.0 65 253* 22.4 65 258* 22.6 65 257* 21.1 65 261* 22.7 65 265* 23.3 40 250* 21.0 40 247* 22.1 40 254* 22.0 40 255* 22.6 40 259* 23.0 40 262* 23.2 40 266* 23.6 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 6 002194 SEX: GROUP: DOSE: WEEK UNITS: 1 0 PPM 15 N 60 MEAN 302 S.D. 42.2 16 N 60 MEAN 307 S.D. 43.9 17 N 60 MEAN 307 S.D. 43.9 21 N 60 MEAN 316 S.D. 44.8 25 N 60 MEAN 331 S.D. 50.9 29 N 60 MEAN 342 S.D. 52.8 33 N 60 MEAN 358 S.D. 58.0 Table 3 Summary of Body Height Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS `DRAFT* -------- FEMALE- 234 5 6 0.5 2 5 20 20 PPM PPM PPM PPM PPM 50 304 36.7 50 310 39.1 50 311 38.3 50 322 40.2 50 335 45.6 50 347 50.0 50 362 55.0 49 294 26.4 49 298 28.2 49 303 26.5 49 314 29.9 49 324 30.7 49 338 36.1 49 356 40.7 50 298 33.3 50 303 33.8 50 305 34.9 50 313 38.2 50 328 42.2 50 342 47.2 49 353 46.8 60 266* 22.0 60 268* 23.1 60 272* 23.6 60 280* 24.1 60 290* 27.8 60 298* 30.2 60 310* 32.8 40 269* 23. 40 271* 24. 40 273* 25. 40 280* 26. 40 291* 29. 40 301* 32. 40 312* 36. C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 7 002JL9S GROUP: DOSE: WEEK UNITS: 37 N MEAN S.D. 41 N MEAN S.D. 45 N MEAN S.D. 49 N MEAN S.D. 53 N MEAN S.D. i 0 PPM 60 373 64.8 60 389 69.4 60 409 73.3 60 422 74.5 60 427 78.8 Table 3 Summary of Body Weight Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* 2 0.5 PPM 49 375 56.7 49 393 62.4 48 413 63.6 48 424 66.3 47 435 71.8 3 2 PPM 49 371 43.4 49 385 50.0 49 396 59.8 47 415 55.7 47 428 61.2 4 5 PPM 49 365 47.3 49 378 49.8 49 394 51.1 49 407 55.1 48 422 56.5 5 20 PPM 60 319* 36.6 59 328* 38.3 59 339* 41.0 59 351* 45.5 59 358* 48.3 6 20 PPM 40 321* 39.8 40 329* 46.5 39 346* 48.0 39 356* 50.0 39 366* 52.6 Covance 6329-183 3M T-6295 PAGE: 8 00219b Table 4 Summary of Body Weight Change Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* SEX: -------------------------------- MALE- GROUP: 1 2 3 4 5 6 DOSE: 0 0.5 2 5 20 20 WEEK UNITS: PPM PPM PPM PPM 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 58 5.8 70 50 6.5 70 47 6.8 65 34 7.6 65 32 6.2 65 20 6.5 65 29 5.8 60 59 5.6 60 53* 6.2 60 42* 8.0 55 38* 6.3 55 32 7.0 55 26* 5.9 55 22* 6.7 60 58 5.2 60 48 6.2 60 43* 7.6 55 38* 6.8 55 30 5.7 55 21 6.3 55 25* 7.2 60 57 4.4 60 55* 7.5 60 43* 6.8 55 34 8.2 55 32 5.3 55 26* 5.8 55 23* 6.7 70 57 5.9 70 50 6.2 70 38* 6.6 65 37 5.6 65 29 5.1 65 23 7.5 65 20* 5.5 40 53* 6.4 40 56* 7.2 40 40* 7.3 40 37 5.8 40 30 6.0 40 21 5.3 40 21* 10.4 Covance 6329-183 3M T-6295 PAGE: 1 002197 GROUP: DOSE: WEEK UNITS: 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. 1 0 PPM 65 17 11.0 65 16 5.7 65 18 5.3 65 10 8.2 65 9 5.8 65 11 5.4 60 7 5.8 Table 4 Summary of Body Weight Change Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* 2 0.5 PPM 55 13 6.1 55 20* 4.7 55 19 5.1 55 10 4.2 55 6* 5.5 55 16* 4.7 50 6 6.5 3 2 PPM 55 7* 5.8 55 23* 6.5 55 6* 6.9 55 15* 9.3 55 14* 6.8 55 9 4.4 50 9 4.7 4 5 PPM 55 18 4.7 55 13* 4.0 55 15* 6.8 55 13* 6.0 55 7 5.1 55 13 4.3 50 11* 5.7 5 20 PPM 65 13 7.9 65 20* 5.3 65 9* 6.5 65 10 5.6 65 8 4.7 65 11 7.1 60 8 4.5 6 20 PPM 40 9* 9.0 40 20* 5.0 40 8* 5.8 40 10 4.3 40 8 5.4 40 10 5.8 40 9 5.1 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 2 002198 GROUP : DOSE: WEEK UNITS: 15-16 N MEAN S.D. 16-17 N 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. 1 0 PPM 60 14 4.7 60 7 5.3 60 25 12.0 59 28 9.9 59 35 13.0 59 26 10.2 59 21 10.3 Table 4 Summary of Body Weight Change Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS d r a f t * 2 0.5 PPM 50 11* 5.6 50 7 4.6 49 34* 10.5 49 27 12.9 49 34 13.5 49 29 10.7 49 17 23.1 3 2 PPM 50 11* 4.7 50 9 4.6 50 30* 11.3 50 30 10.5 50 29* 10.3 50 25 8.9 50 21 13.0 4 5 PPM 50 14 3.9 50 8 4.2 50 23 11.6 50 23 9.9 50 28* 9.6 50 20* 12.1 50 23 9.8 5 20 PPM 60 10* 4.6 60 3* 5.5 60 20 11.4 60 21* 9.9 60 28* 11.7 60 24 12.4 59 26 11.9 6 20 PPM 40 8* 4.6 40 4* 4.7 40 22 10.4 40 22* 12.1 40 30 7.7 40 25 9.7 40 24 11.8 C o v a n e e 3M6 3T2 9- 6- 128935 PAGE: 3 002199 SEX: GROUP : DOSE: WEEK UNITS: 1 0 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 8 12.5 59 16 19.8 58 20 15.6 58 13 15.9 58 570 100.0 Table 4 Summary of Body Weight Change Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* -------- MAIjE---------- 2345 0.5 2 5 20 PPM PPM PPM PPM 6 20 PPM 48 13 11.9 48 19 10.2 48 24 8.9 48 11 15.0 48 593 91.6 50 15* 10.6 50 19 8.6 50 19 9.7 50 13 8.9 50 573 83.0 50 15* 14.2 50 19 12.4 50 17 12.9 48 12 28.3 48 562 96.0 59 19* 11.7 59 13 14.1 58 21 13.8 57 14 13.2 57 535 112.8 40 13 11.4 40 16 10.9 40 24 9.6 40 15 10.3 40 534 104.9 C o v a n c e 3H6 3T2 9- 6- 128935 PAGE: 4 002200 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 29 6.7 70 24 7.0 70 17 7.8 65 14 7.2 65 11 6.5 65 6 5.8 65 13 6.8 Table 4 Summary of Body Weight Change Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* ------- FEMALE- 234 56 0.5 2 5 20 20 PPM PPM PPM PPM PPM 60 26* 7.5 60 24 6.6 60 18 7.0 55 14 7.9 55 14 6.3 55 6 7.4 55 12 5.0 60 21* 6.9 60 23 6.3 60 18 6.9 55 15 8.2 55 13 5.4 55 6 5.9 55 11 7.4 60 26* 6.3 60 24 6.5 60 14 7.3 55 15 7.8 55 12 6.9 55 6 7.3 55 13 6.0 70 25* 7.2 70 22 7.0 70 16 7.6 65 9* 7.4 65 9 5.7 65 3* 5.0 65 11 4.9 40 23* 6.1 40 20* 7.4 . 40 16 8.2 40 13 7.2 40 8* 5.8 40 5 6.0 40 10 5.1 Covance3MS3T29-6-128935 PAGE: 5 I 002201 WEEK SEX: GROUP: DOSE: UNITS: 1 0 PPM 8-9 N MEAN S.D. 9-10 N MEAN S.D. 10-11 N MEAN S.D. 11-12 N MEAN S.D. 12-13 N MEAN S.D. 13-14 N MEAN S.D. 14-15 N MEAN S.D. 65 2 6.0 65 11 6.3 65 2 5.1 65 9 6.3 65 5 7.0 65 5 7.0 60 4 5.8 Table 4 Summary of Body Height Change Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* ------- FEMALE- 234 5 6 0.5 2 5 20 20 PPM PPM PPM PPM PPM 55 4 6.2 55 10 6.8 55 8* 5.7 55 1* 6.6 55 4 5.3 55 7 5.3 50 3 6.5 55 2 4.9 54 8* 5.8 54 6* 5.8 54 1* 5.7 54 7 5.9 54 8* 5.1 49 2 6.0 55 1 6.2 55 11 6.8 55 2 5.7 55 2* 6.0 55 6 4.8 55 7 5.5 50 4 6.4 65 -2* 4.6 65 8* 6.6 65 5* 5.6 65 -1* 5.8 65 3 5.3 65 4 5.1 60 1 5.4 40 -3* 4.6 40 7* 5.5 40 0 4.9 40 4* 4.6 40 3 5.0 40 5 4.3 40 2 3.8 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 6 002202 WEEK oca: GROUP : DOSE: UNITS: 1 0 PPM 15-16 N MEAN S.D. 16-17 N 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. 60 4 4.4 60 0 6.5 60 9 8.1 60 15 9.2 60 12 7.8 60 16 10.8 60 15 12.9 Table 4 Summary of Body Weight Change Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* 2 0.5 PPM 50 6 5.3 50 1 4.8 50 11 6.7 50 13 9.9 SO 12 9.8 50 15 13.1 49 15 12.2 3 2 PPM 49 4 5.7 49 4* 7.0 49 11 10.6 49 10* 11.3 49 15 11.9 49 18 13.8 49 14 9.9 4 5 PPM 50 5 5.6 50 3 6.2 50 7 8.9 50 16 9.3 50 14 9.9 49 13 10.0 49 12 9.9 5 20 PPM 60 3 5.3 60 4* 4.5 60 8 6.6 60 9* 9.0 60 9 8.0 60 12 9.7 60 9* 8.2 6 20 PPM 40 3 4.1 40 2 5.1 40 7 6.9 40 11 5.5 40 9 7.6 40 12 9.6 40 9 10.5 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 7 02200 SEX: GROUP: DOSE: WEEK UNITS: 3T-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. i 0 PPM 60 16 10.5 60 19 9.8 60 13 16.3 60 5 20.8 60 273 73.5 Table 4 Summary o t Body Weight Change Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANB SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* -FEMALE- 23456 0.5 2 5 20 20 PPM PPM PPM PPM PPM 49 18 13.7 48 18 13.0 48 11 9.0 47 11* 10.6 47 282 66.7 49 14 18.0 49 11 33.2 47 13 8.8 47 13* 11.1 47 274 57.9 49 13 8.9 49 17 12.4 49 13 11.6 48 14* 10.4 48 268 51.4 59 10* 9.3 59 11* 7.5 59 12 9.3 59 7 10.5 59 206* 46.0 40 8* 16.7 39 14* 10.1 39 10 8.9 39 10 7.3 39 211* 48.6 Covance3M63T29-6-128935 PAGE: 8 i 002204 Table 5 Summary of Food Consumption Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* SEX: -------------------------------- MALE' GROUP: 1 2 3 4 5 6 DOSE: 0 0.5 2 5 20 20 WEEK UNITS: PPM PPM PPM PPM PPM PPM 1N 69 MEAN 167 S.D. 13.3 2N 62 MEAN 177 S.D. 13.9 3N 68 MEAN 184 S.D. 12.9 4N 60 MEAN 191 S.D. 16.5 5N 62 MEAN 191 S.D. 16.1 6N 56 MEAN 192 S.D. 15.1 7N 59 MEAN 193 S.D. 15.6 56 165 11.5 54 173 12.9 52 183 13.0 47 188 13.7 50 193 16.1 43 191 17.3 42 195 18.3 60 165 14.1 58 173 13.9 56 181 14.1 49 184 19.3 50 186 16.7 46 187 15.9 47 183* 18.8 59 164 13.2 54 172 13.4 57 182 13.4 48 177* 15.0 49 185 16.3 49 186 16.4 45 187 17.2 69 158* 11.6 69 167* 13.8 70 178 15.2 62 176* 14.7 64 183* 15.6 65 181* 15.9 60 183* 15.4 39 166 14.2 37 172 17.2 38 181 16.0 38 184 17.4 40 187 18.7 38 185 17.6 37 184 19.9 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 1 002205 Table 5 Summary of Food Consumption Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* SEX: -------------------------------- MALE- GROUP: 1 2 3 4 5 6 DOSE: 0 0.5 2 5 20 20 WEEK UNITS : PPM PPM PPM PPM PPM PPM 8N 54 MEAN 189 S.D. 19.2 9N 59 MEAN 190 S.D. 18.0 10 N 59 MEAN 188 S.D. 18.0 11 N 60 MEAN 188 S.D. 16.8 12 N 57 MEAN 189 S.D. 20.1 13 N 60 MEAN 185 S.D. 19.2 14 N 59 MEAN 184 S.D. 17.4 45 193 17.9 47 190 16.9 48 189 17.6 46 189 18.3 51 189 18.5 52 187 17.4 49 186 19.0 47 188 17.7 51 183 17.4 46 188 17.2 48 183 17.7 52 184 20.5 54 187 16.8 48 188 18.9 43 185 15.3 46 190 15.5 48 183 15.6 45 185 15.7 49 185 16.7 52 185 18.8 45 182 17.0 60 178* 18.0 60 175* 17.0 59 177* 15.1 59 179* 17.8 61 180 21.1 63 180 19.6 57 178 16.0 34 181 19.7 32 182 17.8 38 185 19.1 38 182 18.9 39 178* 18.6 37 178 21.0 38 184 20.8 C o v a n c e 3M6 3T2 9- -6128935 PAGE: 2 90ZZ00 GROUP DOSE WEEK UNITS 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. Table 5 Summary of Food Consumption Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* -----------------------------m a l e ------------------------------ 1234 5 6 0 0.5 2 5 20 20 PPM PPM PPM PPM PPM PPM 58 190 16.7 57 190 16.5 58 192 19.7 58 184 20.1 56 183 20.4 58 177 16.8 59 183 17.9 47 188 18.8 49 191 17.3 46 195 17.9 48 188 20.1 46 185 15.6 45 184 14.4 48 181 28.3 47 191 16.0 48 192 14.0 49 194 16.1 49 192 18.6 48 185 17.5 48 184 15.3 50 181 16.6 45 187 14.7 49 191 19.5 47 188 20.9 50 184 20.2 46 181 16.3 47 182 17.4 50 183 19.9 56 182 17.1 59 183 17.6 57 184 18.3 60 178 20.3 59 180 18.7 59 182 19.3 58 183 21.1 40 185 18.7 38 183 18.6 38 184 21.3 39 178 21.5 36 180 17.8 35 179 18.7 39 181 23.0 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 3 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 58 184 19.1 58 182 24.9 57 184 20.2 54 176 27.6 Table 5 Summitry of Food Consumption Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* 2 0.5 PPM 46 184 19.1 48 188 21.0 48 191 18.5 46 185 17.8 3 2 PPM 48 186 16.2 49 185 14.7 48 186 18.8 48 186 17.3 4 5 PPM 48 187 20.3 47 186 20.0 47 185 18.3 44 181 27.5 5 20 PPM 58 187 22.5 55 184 20.7 55 184 20.8 54 178 22.4 6 20 PPM 39 182 22.7 39 188 23.9 37 185 18.3 37 179 20.9 Covance 6329-183 3M T-6295 PAGE: 4 ( 002208 GROUP : DOSE: WEEK UNITS: 1 0 PPM 1N 55 MEAN 129 S.D. 11.9 2N 62 MEAN 140 S.D. 16.9 3N 54 MEAN 144 S.D. 16.8 4N 47 MEAN 140 S.D. 15.9 5N 50 MEAN 146 S.D. 18.5 6N 45 MEAN 138 S.D. 18.6 7N 54 MEAN 138 S.D. 17.0 Table 5 Summary of Food Consumption Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* 2 0.5 PPM 55 120* 12.0 48 133 16.5 49 142 17.0 44 137 17.5 48 146 17.6 40 142 23.3 49 142 17.1 3 2 PPM 48 123 14.3 51 131* 17.8 51 140 17.6 41 142 20.1 43 144 14.2 35 137 20.3 45 133 12.2 4 5 PPM 55 130 13.5 47 136 19.6 55 141 14.9 45 138 18.3 45 144 19.3 42 134 17.3 46 13 6 16.3 5 20 PPM 62 124 11.2 62 130* 13.8 57 131* 14.7 58 126* 12.5 55 135* 14.0 55 124* 11.4 53 126* 10.7 6 20 PPM 35 125 12.4 34 126* 12.7 33 129* 13.3 33 128* 14.0 33 130* 11.4 31 124* 13.1 36 123* 12.0 Covan ee3H63T29-6-128935 PAGE: 5 ft o oQ t GROUP: DOSE: WEEK 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 46 138 18.5 55 140 18.8 53 141 18.2 56 138 21.7 52 138 20.1 56 133 17.7 53 131 20.4 Table 5 Summary of Food Consumption Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS `DRAFT* 2 0.5 PPM 38 138 15.9 48 135 15.2 45 135 16.0 52 134 15.5 43 133 15.7 46 135 17.7 40 129 18.0 3 2 PPM 43 136 11.3 41 132 17.0 39 134 11.0 46 133 13.4 39 137 17.6 47 131 13.1 37 133 13.4 4 5 PPM 42 135 15.5 46 134 17.3 45 135 13.8 48 134 16.0 48 13 6 21.5 49 131 20.1 40 125 11.3 5 20 PPM 54 123* 14.7 56 122* 12.6 53 124* 10.0 55 122* 10.2 58 127* 18.8 59 122* 18.4 54 119* 11.3 6 20 PPM 31 121* 12.6 36 125* 17.5 34 125* 14.4 38 125* 14.8 35 123* 11.7 35 125 16.8 32 122* 8.5 Covance3M63T29-6-128935 PAGE: 6 0 2 2 lo GROUP : DOSE: WEEK UNITS: i 0 PPM 15 N 53 MEAN 133 S.D. 17.1 16 N 54 MEAN 133 S.D. 19.4 20 N 50 MEAN 139 S.D. 19.0 24 N 53 MEAN 134 S.D. 18.9 28 N 56 MEAN 132 S.D. 15.7 32 N 58 MEAN 13 6 S.D. 18.4 36 N 55 MEAN 135 S.D. 17.9 Table 5 Summary of Food Consumption Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS `DRAFT* 2 0.5 PPM 49 134 15.9 44 135 18.1 46 134 16.0 44 132 18.7 48 133 24.7 47 134 26.5 49 135 20.9 3 2 PPM 43 135 14.9 41 13 6 15.3 42 136 16.2 44 136 17.6 45 141 20.5 45 139 15.5 46 137 15.3 4 5 PPM 45 133 16.2 45 133 15.6 44 138 18.8 47 132 20.0 48 132 18.7 45 134 17.9 47 133 17.8 5 20 PPM 57 124* 13.6 56 124* 12.2 49 128* 12.8 54 123* 14.0 56 122* 20.4 58 124* 17.4 58 124* 16.1 6 20 PPM 39 125 17.7 34 124 15.0 28 131 14.2 32 122* 13.3 40 121* 18.9 40 127 17.7 39 123* 14.9 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 7 002211 WEEK a: GROUP: DOSE: UNITS: i 0 PPM 40 N 56 MEAN 139 S.D. 20.3 44 N 56 MEAN 137 S.D. 17.8 48 N 58 MEAN 134 S.D. 23.6 52 N 57 MEAN 133 S.D. 24.0 Table 5 Summary of Pood Consumption Data (g) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* 2 0.5 PPM 44 139 15.6 45 134 19.3 48 133 19.5 45 134 20.5 3 2 PPM 48 142 20.6 45 137 18.6 47 142 16.6 46 141 19.8 4 5 PPM 47 138 17.6 47 134 20.7 47 141 17.8 45 139 22.2 5 20 PPM 56 135* 20.7 53 126* 17.1 57 133 20.0 57 133 21.9 6 20 PPM 38 130 14.7 38 128 15.9 38 130 13.3 38 133 14.0 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 8 t 002212 002213 Table 6 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 1 SEX: GROUP: DOSE: UNITS: 2 0.5 PPM 3 2 PPM 4 5 PPM 5 20 PPM 6 20 PPM 2 0.5 PPM 3 2 PPM --- FEMALE-4 5 PPM 5 20 PPM 6 20 PPM 1N 56 60 59 69 39 55 48 55 62 35 MEAN 0.057 0.226 0.570 2.205 2.336 0.052 0.213 0.559 2.149 2.160 S.D. 0.004 0.015 0.041 0.156 0.170 0.004 0.020 0.046 0.141 0.178 2N 54 58 54 69 37 48 51 47 62 34 MEAN 0.047 0.189 0.471 1.846 1.907 0.050 0.200 0.506 1.965 1.929 S.D. 0.003 0.012 0.031 0.115 0.118 0.005 0.019 0.055 0.162 0.164 3N 52 56 57 70 38 49 51 55 57 33 MEAN 0.042 0.169 0.420 1.675 1.701 0.048 0.194 0.481 1.805 1.792 S.D. 0.002 0.010 0.026 0.097 0.097 0.003 0.026 0.038 0.157 0.126 4N 47 49 48 62 38 44 41 45 58 33 MEAN 0.038 0.151 0.364 1.477 1.531 0.043 0.180 0.440 1.646 1.656 S.D. 0.002 0.011 0.020 0.081 0.086 0.003 0.018 0.049 0.121 0.142 5N 50 50 49 64 40 48 43 45 55 33 MEAN 0.036 0.139 0.346 1.394 1.408 0.043 0.170 0.431 1.669 1.613 S.D. 0.002 0.007 0.019 0.072 0.073 0.003 0.011 0.03 6 0.137 0.113 6N MEAN S.D. 43 0.033 0.002 46 0.132 0.007 49 0.325 0.017 65 1.287 0.065 38 1.307 0.068 40 0.040 0.005 35 0.157 0.019 42 0.390 0.034 55 1.502 0.106 31 1.488 0.107 7N 42 47 45 60 37 49 45 46 53 36 MEAN 0.032 0.122 0.311 1.241 1.233 0.038 0.148 0.382 1.501 1.446 S.D. 0.002 0.010 0.016 0.061 0.078 0.003 0.010 0.028 0.112 0.089 002214 Table 6 Suimnaty o Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS C o v a n c e 3M6 3T2 9-6- 128935 PAGE: 2 SEX: ------------ ---------------MALE----------- GROUP: 2 3 4 5 DOSE: 0.5 2 5 20 WEEK UNITS: PPM PPM PPM PPM -------6 20 PPM ------------------------- FEMALE---------------------- 23 45 6 0.5 2 5 20 20 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 0.030 0.002 47 0.029 0.001 48 0.028 0.002 46 0.027 0.002 51 0.026 0.002 52 0.025 0.002 49 0.025 0.002 47 0.121 0.007 51 0.113 0.006 46 0.113 0.006 48 0.108 0.007 52 0.106 0.009 54 0.105 0.006 48 0.102 0.007 43 0.293 0.012 46 0.288 0.016 48 0.270 0.017 45 0.266 0.014 49 0.262 0.016 52 0.256 0.017 45 0.248 0.018 60 1.161 0.093 60 1.108 0.076 59 1.074 0.060 59 1.056 0.060 61 1.055 0.101 63 1.029 0.093 57 1.007 0.073 34 1.178 0.106 32 1.135 0.063 38 1.130 0.080 38 1.086 0.071 39 1.050 0.075 37 1.024 0.080 38 1.043 0.104 38 0.036 0.002 48 0.035 0.002 45 0.033 0.002 52 0.033 0.003 43 0.032 0.003 46 0.032 0.003 40 0.030 0.004 43 0.148 0.011 41 0.143 0.023 39 0.138 0.010 46 0.136 0.011 39 0.137 0.015 47 0.129 0.011 37 0.130 0.012 42 0.368 0.030 46 0.355 0.027 45 0.355 0.033 48 0.346 0.029 48 0.344 0.040 49 0.324 0.026 40 0.310 0.031 54 1.438 0.133 56 1.407 0.120 53 1.393 0.101 55 1.361 0.101 58 1.406 0.193 59 1.330 0.194 54 1.289 0.118 31 1.392 0.099 36 1.422 0.202 34 1.407 0.111 38 1.393 0.120 35 1.363 0.126 35 1.355 0.130 32 1.313 0.101 ST2200 Table 6 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 3 SEX: GROUP: DOSE: UNITS: 2 0.5 PPM 3 2 PPM ---- MALE--4 5 PPM 5 20 PPM 6 20 PPM 2 0.5 PPM 3 2 PPM --- FEMALE-4 5 PPM 5 20 PPM 6 20 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. 47 0.025 0.002 49 0.025 0.002 46 0.024 0.001 48 0.022 0.002 46 0.021 0.002 45 0.019 0.001 48 0.019 0.003 47 0.102 0.006 48 0.100 0.006 49 0.096 0.007 49 0.090 0.007 48 0.083 0.006 48 0.080 0.006 50 0.076 0.008 45 0.250 0.013 49 0.247 0.017 47 0.234 0.020 50 0.219 0.018 46 0.206 0.016 47 0.199 0.012 50 0.195 0.021 56 1.010 0.074 59 1.006 0.084 57 0.969 0.065 60 0.904 0.070 59 0.875 0.082 59 0.850 0.083 58 0.817 0.084 40 1.032 0.069 38 1.010 0.067 38 0.970 0.073 39 0.904 0.084 36 0.872 0.069 35 0.837 0.059 39 0.805 0.046 49 0.031 0.004 44 0.031 0.004 46 0.030 0.003 44 0.028 0.004 48 0.028 0.005 47 0.027 0.006 49 0.026 0.003 43 0.129 0.011 41 0.129 0.016 42 0.124 0.012 44 0.120 0.015 45 0.121 0.022 45 0.112 0.013 46 0.106 0.012 45 0.318 0.023 45 0.315 0.027 44 0.316 0.029 47 0.288 0.024 48 0.279 0.025 45 0.273 0.028 47 0.261 0.023 57 1.330 0.121 56 1.315 0.113 49 1.305 0.104 54 1.218 0.110 56 1.181 0.164 58 1.152 0.111 58 1.111 0.099 39 1.333 0.160 34 1.302 0.132 28 1.345 0.105 32 1.200 0.098 40 1.157 0.174 40 1.170 0.155 39 1.103 0.080 002216 Table 6 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covanee 6329-183 3M T-6295 PAGE: 4 GROUP: DOSE: WEEK UNITS: 2 0.5 PPM 40 44 48 52 1-52 N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. MEAN 46 0.018 0.002 48 0.018 0.002 48 0.018 0.002 46 0.017 0.002 0.028 3 2 PPM 48 0.076 0.005 49 0.074 0.006 48 0.072 0.007 48 0.071 0.006 0.115 4 5 PPM 48 0.196 0.020 47 0.188 0.017 47 0.184 0.017 44 0.174 0.025 0.284 5 20 PPM 58 0.812 0.090 55 0.786 0.069 55 0.765 0.080 54 0.714 0.082 1.147 6 20 PPM 39 0.794 0.052 39 0.801 0.055 37 0.780 0.049 37 0.732 0.053 1.146 2 0.5 PPM 44 0.025 0.003 45 0.024 0.003 48 0.023 0.003 45 0.022 0.003 0.034 3 2 PPM 48 0.106 0.014 45 0.098 0.012 47 0.099 0.013 46 0.095 0.012 0.139 4 5 PPM 47 0.263 0.025 47 0.244 0.027 47 0.247 0.020 45 0.237 0.028 0.348 5 20 PPM 56 1.179 0.132 53 1.069 0.112 57 1.100 0.137 57 1.070 0.125 1.402 6 20 PPM 38 1.122 0.092 38 1.065 0.128 38 1.054 0.119 38 1.047 0.097 1.375 Table 7 Summary of Clinical Hematology Data Males Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT 6295 XIOV^L G/DL % FL PG % XIO'/^L 0.5 2.0 5.0 20.0 MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 7.47 .459 10 7.22 .414 10 7.54 .599 10 7.43 .622 10 7.30 .234 10 15.2 .81 10 14.7 .77 10 15.3 1.09 10 15.4 1.04 10 15.0 .44 10 44.8 2.35 10 43.4 2.43 10 45.1 3.39 10 45.0 3.32 10 44.2 1.56 10 60.0 1.56 10 60.2 1.69 10 59.9 1.65 10 60.7 1.97 10 60.6 1.40 10 20.3 .73 10 20.4 .67 10 20.4 .85 10 20.7 .68 10 20.6 .45 10 33.9 .59 10 33.9 .36 10 34.0 .61 10 34.1 .41 10 33.9 .37 10 1048 107 10 1082 111 10 1028 68 10 1013 118 10 1051 118 10 C o v a n c e 3M6 3T2 9- 6- 128935 OOJcilV 002218 Table 7 Summary of Clinical Hematology Data Hales Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE WBC -6295 XIOV^L N-SEG LYMPH XIOV^L x i o 3/a<l MONO EOSIN BASO X10V//L XIOV^L XlOV^tL N-SEG% LYMPH% MONO% EOSIN% C o v a n ce 3M6 3T2 9-6- 128935 BASO% MEAN 8.6 .7 7.2 .6 .1 .0 9 83 7 1 0 S.D. 2.03 .30 1.92 .16 .06 .00 3.5 5.3 2.2 .5 .0 N 10 1 0 10 10 10 10 10 10 10 10 10 0.5 MEAN 9.3 1.2 7.4 .6 .1 .0 12 82 610 S.D. 2.54 1.32 1.29 .31 .06 .00 7.6 9.1 2.5 .3 .0 N 10 10 10 10 10 10 10 10 10 10 10 2.0 MEAN 9.3 .7 8.0 .6 .1 .0 7 86 610 S.D. 2.30 .23 1.94 .26 .06 .00 1.4 3.4 2.3 .5 .0 N 10 10 10 10 10 10 10 10 10 10 10 5.0 MEAN 7.2 .6 6.1 .4 .1 .0 8 85 620 S.D. 1.15 .21 .99 .24 .15 .00 2.3 6.5 2.9 2.0 N 10 10 10 10 10 10 10 10 10 10 10 20.0 MEAN S.D. 8.4 2.87 .8 6.8 .46 2.19 .6 .38 .1 .07 .0 .00 10 2.8 83 4.8 6 2.4 1 .4 0.0 N 10 10 10 10 10 10 10 10 10 10 10 Table 7 Summary of Clinical Hematology Data Females Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT ppm T-6295 X10`/i<L G/DL % FL PG % XIOV^L 0 MEAN S.D. N MEAN S.D. N 2.0 MEAN S.D. N 20.0 MEAN S.D. N MEAN S.D. N 7.28 .276 10 7.40 .367 10 7.49 .367 10 7.40 .396 10 7.38 .238 10 15.2 .45 10 15.3 .62 10 15.1 .70 10 15.4 .42 10 15.3 .27 10 45.1 1.20 10 45.7 1.46 10 45.2 1.64 10 45.8 1.00 10 45.6 1.07 10 62.0 1.80 10 61.8 1.36 10 60.4 1.62 10 62.0 2.25 10 61.9 1.21 10 20.8 .63 10 20.7 .58 10 20.2 .64 10 20.8 .79 10 20.8 .64 10 33.7 .41 10 33.5 .57 10 33.5 .55 10 33.6 .52 10 33.6 .53 10 1103 109.6 10 1126 181.3 10 1069 128.2 10 1104 116 10 1108 88 10 C ov a n c e 3M63T29- -183 6295 002219 002,22.0 Table 7 Summary of Clinical Hematology Data Females Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE WBC ppm T 6295 X103/^L N-SEG LYMPH XIOV/tf, XIO'/^L MONO EOSIN BASO XIOVm L XIOVaL XIOVaL N-SEG% LYMPH% MONO% EOSIN% C o v a n c e 3M6 3T2 9- 6- 128935 BASO% 0 MEAN 7.4 .7 6.3 .3 .1 .0 9 84 52 0 S.D. 2.27 .23 2.12 .20 .06 .00 3.5 4.0 2.2 1.4 N 10 10 10 10 10 10 10 10 10 10 10 0.5 MEAN 6.5 .7 5.5 .3 .0 .0 10 84 4 1 0 S.D. 1.01 .78 1.01 .13 .05 .00 10.8 10.4 1.7 .6 N 10 10 10 10 10 10 10 10 10 10 10 2.0 MEAN 5.0 .4 4.3 .2 .0 .0 9 84 51 0 S.D. 1.80 .15 1.83 .11 .05 .00 5.1 7.9 3.5 .6 N 10 10 10 10 10 10 10 10 10 10 10 5.0 MEAN 6.9 .5 6.0 .2 .1 .0 8 87 4 1 0 S.D. 2.88 .23 2.62 .11 .04 .00 2.1 3.7 1.7 .6 N 10 10 10 10 10 10 10 10 10 10 10 20.0 MEAN 6.2 .5 5.4 .2 .1 .0 8 86 4 10 S.D. 1.80 .17 1.72 .14 .04 .00 2.7 4.6 2.1 .7 N 10 10 10 10 10 10 10 10 10 10 10 Table 8 Summary of Clinical Hematology Data Males Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT ppm T-6295 XlOV/^L G/DL % FL PG % XIO'/^L 0 MEAN S.D. N MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 8.55 .446 10 8.77 .441 10 8.68 .456 10 8.57 .478 10 8.23 .216 10 15.6 .69 10 15.8 .56 10 15.7 .60 10 15.2 .63 10 15.1 .51 10 45.9 1.83 10 46.7 1.45 10 46.5 1.65 10 45.2 1.61 10 44.6 1.30 10 53.7 1.52 10 53.3 1.68 10 53.6 2.19 10 52.8 1.64 10 54.2 1.42 10 18.3 .56 10 18.0 .48 10 18.1 .60 10 17.8 .48 10 18.4 .51 10 34.1 .55 10 33.9 .53 10 33.7 .47 10 33.7 .49 10 33.9 .38 10 1142 164.6 10 1092 104.7 10 1168 189.6 10 1078 155.6 10 1139 124.3 10 Covance3M63T29--6128935 002221 Table 8 Summary of Clinical Hematology Data Males Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE WBC ppm T 6295 XlOVnL N-SEG LYMPH XlO'/bL XIOVaL MONO EOSIN BASO XIOVbL XIOVwL XIOVaL N-SEG% LYMPH% MONO% EOSIN% Covance3M63T29-6-128935 BASO% 0 MEAN 8.2 1.1 6.1 .8 .2 .0 14 74 10 2 0 S.D. 1.95 .37 1.46 .27 .07 .03 3.1 3.2 2.1 .6 N 10 10 10 10 10 10 10 10 10 10 10 0.5 MEAN 8.5 1.3 6.2 .8 .2 .0 15 73 10 2 0 S.D. 1.20 .28 1.04 .19 .10 .00 3.6 4.5 1.6 1.1 N 10 10 10 10 10 10 10 10 10 10 10 2.0 MEAN 7.8 1.2 5.7 .8 .2 .0 15 73 10 2 0 S.D. 1.64 .33 1.20 .29 .07 .03 1.8 3.8 2.8 1.1 N 10 10 10 10 10 10 10 10 10 10 10 5.0 MEAN 7.8 1.2 5.7 .7 .2 .0 16 73 9 2 0 S.D. 2.08 .37 1.97 .20 .05 .00 4.5 6.1 2.5 .6 N 10 10 10 10 10 10 10 10 10 10 10 20.0 MEAN 10.5 1.6 * 7.8 .9 .2 .0 16 73 8 2 0 S.D. 3.65 .35 3.43 .39 .08 .03 5.4 7.3 4.2 .7 N 10 10 10 10 10 10 10 10 10 10 10 CNvi oCONM Table 8 Summary of Clinical Hematology Data Females Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT ppm T-6295 XIOV^L G/DL % FL PG % XIOV^L MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N 8.00 .535 10 8.22 .377 10 8.06 .253 10 7.97 .453 10 7.87 .247 10 15.3 .87 10 15.5 .59 10 15.2 .58 10 15.2 .70 10 15.1 .67 10 45.2 2.58 10 46.0 1.80 10 45.2 1.76 10 45.0 2.17 10 44.2 1.82 10 56.6 1.18 10 56.0 1.93 10 56.1 2.37 10 56.5 1.32 10 56.2 1.64 10 19.1 .25 10 18.9 .74 10 18.8 .72 10 19.0 .41 10 19.2 .59 10 33.8 .57 10 33.7 .91 10 33.6 .57 10 33.7 .65 10 34.1 1.08 10 1061 68 10 1143 67 10 1070 93 10 1082 64 10 1144 122 10 C o v a n c e 3M6 3T2 9- 6- 128935 Czzzoo Cv* zzoo Table 8 Summary of clinical Hematology Data Females Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE WBC 6295 XIOVm L N-SEG LYMPH XIOVm I* XIOV^L MONO EOSIN BASO XIOVm L XlOVliL XIOV^L N-SEG% LYMPH% MONO% EOSIN% C o v a n c e 3M6 3T2 9-6- 128935 BASO% MEAN 4.9 1.0 3.4 .4 .1 .0 20 69 8 2 0 S.D. 1.51 .53 1.14 .17 .07 .00 8.8 9.7 2.9 .9 .0 N 10 10 10 10 10 10 10 10 10 10 10 0.5 MEAN 6.4 1.0 4.8 .5 .1 .0 16 73 92 0 S.D. 2.64 .45 2.18 .25 .03 .00 5.1 9.1 4.0 .8 .0 N 10 10 10 10 10 10 10 10 10 10 10 2.0 MEAN 4.9 .7 3.9 .3 .1 .0 14 77 62 0 S.D. 1.65 .17 1.50 .08 .03 .00 4.4 5.1 1.2 .9 .0 N 10 10 10 10 10 10 10 10 10 10 10 5.0 MEAN 5.8 .9 4.4 .4 .1 .0 15 75 8 2 0 S.D. 1.96 .55 1.54 .32 .05 .03 7.1 7.7 3.9 .8 .4 N 10 10 10 10 10 10 10 10 10 10 10 20.0 MEAN S.D. 4.8 1.68 1.0 .64 3.4 1.12 .3 .17 .1 .06 .0 .00 19 6.3 72 6.7 7 2.5 2 1.3 0.3 N 10 10 10 10 10 10 10 10 10 10 10 Table 9 Summary of Clinical Hematology Data Males Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT ppm T-6295 XIOVm L G/DL % FL PG % XlOV^iL 0 0.5 2.0 5.0 20.0 MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 8.78 .471 10 8.84 .629 10 8.82 .301 10 9.04 .439 10 8.67 .252 10 15.7 .58 10 15.5 .84 10 15.5 .54 10 15.8 .60 10 15.1 .62 10 46.1 1.96 10 46.0 2.34 10 45.6 1.62 10 46.6 1.84 10 44.7 1.22 10 52.6 1.60 10 52.1 1.63 10 51.8 1.01 10 51.6 1.40 10 51.6 2.06 10 17.9 .56 10 17.6 .60 10 17.5 .45 10 17.4 .58 10 17.4 .83 10 34.0 .34 10 33.7 .31 10 33.9 .38 10 33.8 .36 10 33.8 .57 10 1235 171.4 10 1270 138.4 10 1237 127.7 10 1217 116.4 10 1287 162.9 10 C o v a n c e 3M6 3T2 9- 6- 128935 002225 Table 9 Summary of Clinical Hematology Data Hales Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE WBC ppm T -6295 XIOVm L N-SEG LYMPH XIOVm L XIOViiL MONO EOSIN BASO xioV ml XIOV^L XIOVm L N-SEG% LYMPH% MONO% EOSIN% C o v a n c e 3M6 3T2 9- 6- 128935 BASO% 0 MEAN 7.5 1.3 5.0 1.0 .2 .0 18 67 13 2 1 S.D. 1.43 .29 1.14 .23 .08 .05 4.1 3.9 2.1 1.0 .5 N 10 10 10 10 10 10 10 10 10 10 10 0.5 MEAN 8.2 1.5 5.6 .9 .2 .0 19 67 11 2 1 S.D. 1.42 .31 1.40 .19 .03 .05 5.6 6.2 2.3 .7 .5 N 10 10 10 10 10 10 10 10 10 10 10 2.0 MEAN 8.7 1.7 5.7 1.0 .2 .0 19 66 12 2 0 S.D. 1.53 .52 1.28 .26 .07 .04 6.1 7.8 2.2 .6 .5 N 10 10 10 10 10 10 10 10 10 10 10 5.0 MEAN 8.6 1.6 5.7 1.2 .2 .0 19 65 14 2 1 S.D. 1.88 .31 1.74 .32 .05 .05 4.5 6.7 3.0 .4 .5 N 10 10 10 10 10 10 10 10 10 10 10 20.0 MEAN 8.7 1.6 5.9 1.0 .1 .0 18 68 12 2 0 S.D. 1.88 .42 1.41 .28 .05 .04 3.2 4.9 2.6 .7 ,5 N 10 10 10 10 10 10 10 10 10 10 10 9ZZZ0 Table 9 Summary of Clinical Hematology Data Females Week 27 104- WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT ppm ' -6295 XIOV/iL G/DL % FL PG % x i o V m l 0 0.5 2.0 5.0 20.0 MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 7.56 .563 10 7.93 .639 10 8.00 .312 10 8.12 .353 10 7.73 .398 10 14.6 .97 10 43.5 3.16 10 57.6 1.06 10 14.9 .52 10 44.8 1.92 10 56.8 2.94 10 15.1 .66 10 45.2 1.94 10 56.5 1.44 10 15.3 * .61 10 46.1 * 1.61 10 56.8 1.20 10 14.5 .53 10 43.3 1.70 10 56.1 1.87 10 19.2 .33 10 18.9 1.18 10 18.9 .53 10 18.9 .57 10 18.8 .66 10 33.4 .63 10 33.3 .35 10 33.4 .32 10 33.3 .44 10 33.5 .39 10 1051 121 10 1057 127 10 1074 75 10 1095 131 10 1062 153 10 C ov ance 3M63T29- -183 6295 002227 00ZZ28 Table 9 Summary of Clinical Hematology Data Females Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS C o v a n c e 3M6 3T2 9- 6- 128935 DOSE WBC ppm T 6295 XIOV^L N-SEG LYMPH XIOViiL XIOVm L MONO EOSIN BASO XIOV^L XIOV^L XIOV/iL N-SEG% LYMPH% MONO% EOSIN% BASO% 0 MEAN 5.5 .9 4.0 .6 .1 .0 16 72 10 2 0 S.D. .77 .54 .63 .26 .10 .03 9.1 9.9 3.3 1.3 .4 N 10 10 . 10 10 10 10 10 10 10 10 10 0.5 MEAN 6.7 1.1 5.0 .5 .1 .0 14 77 7 2 0 S.D. 4.82 1.22 3.24 .33 .05 .03 5.3 5.6 3.2 .6 .3 N 10 10 10 10 10 10 10 10 10 10 10 2.0 MEAN 4.8 .7 3.6 .4 .1 .0 15 74 8 2 0 S.D. 1.17 .21 .97 .18 .03 .00 3.1 6.0 3.4 1.1 .0 N 10 10 10 10 10 10 10 10 10 10 10 5.0 MEAN 6.1 .8 4.7 .5 .1 .0 14 76 8 2 0 S.D. 1.95 .23 1.74 .24 .05 .00 4.8 6.5 3.9 .6 .4 N 10 10 10 10 10 10 10 10 10 10 10 20.0 MEAN S.D. 5.9 1.61 .9 4.4 .55 1.41 .4 .18 .1 .04 .0 .00 16 8.4 75 10.7 7 3.2 2 1.0 0.5 N 10 10 10 10 10 10 10 10 10 10 10 Table 10 Summary of Clinical Hematology Data Males Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT ppm T-6295 XlO'/jiL G/DL % FL PG % XIOV^L 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 8.33 .286 10 8.33 .266 10 8.11 .288 10 8.43 .536 10 8.28 .360 9 15.5 .70 10 15.2 .21 10 14.9 .64 10 15.2 .45 10 14.9 .71 9 43.5 2.02 10 43.4 .77 10 42.5 1.63 10 43.7 1.56 10 41.7 1.74 9 52.3 1.70 10 52.1 1.23 10 52.4 1.79 10 52.0 2.41 10 50.4 1.58 9 18.6 .59 10 18.3 .57 10 18.4 .75 10 18.0 .94 10 17.9 .47 9 35.6 .38 10 1112 155 10 35.1 .49 10 1059 172 10 35.1 .36 10 931 108 10 34.7 * .58 10 1011 111.9 10 35.6 .49 9 1241 124 9 C o v a n c e 3M6 3T2 9- 6- 128935 002229 002230 Table 10 Summary of Clinical Hematology Data Males Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE WBC 6295 XIOVm L N-SEG LYMPH X103/m L X103/^L MONO EOSIN BASO XIOV/iL X103/*iL X10V/ N-SEG% LYMPH% MONO% EOSIN C o v a n c e 3M6 3T2 9- 6- 128935 BASO MEAN 7.1 2.4 3.6 .9 .1 .0 34 51 13 2 0 S.D. 1.33 .96 .96 .26 .05 .00 11.9 10.6 3.2 .6 .4 N 10 10 . 10 10 10 10 10 10 10 10 10 0.5 MEAN 7.8 1.7 4.9 * 1.1 .1 .0 22 * 63 * 14 2 0 S.D. 1.59 .31 1.10 .32 .06 .03 3.0 4.0 2.5 .7 .4 N 10 10 10 10 10 10 10 10 10 10 10 2.0 MEAN 8.6 2.1 5.4 * 1.0 .1 .0 22 * 64 * 11 1 0 S.D. 2.97 1.64 1.20 .65 .04 .03 7.6 10.2 4.5 .5 .0 N 10 10 10 10 10 10 10 10 10 10 10 5.0 MEAN 8.5 2.0 5.4 * .9 .1 .0 24 63 * 11 2 0 S.D. 1.63 .74 1.28 .33 .04 .00 6.2 7.9 2.6 .5 .0 N 10 10 10 10 10 10 10 10 10 10 10 20.0 MEAN 7.3 2.3 4.0 .8 .1 .0 30 56 12 2 0 S.D. 1.78 1.58 1.29 .42 .03 .03 12.3 15.1 5.0 .5 .3 N 99 999999 999 Table 10 Summary of Clinical Hematology Data Females Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE RBC HGB HCT MCV MCH MCHC PLT 6295 X10`/m l G/DL % FL PG % XIOVaL MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N 7.39 .485 10 7.26 .695 10 7.31 .566 10 7.32 .479 10 7.05 .881 10 14.5 .76 10 14.2 1.04 10 14.3 .61 10 14.2 .56 10 13.5 1.66 10 40.5 1.84 10 41.0 3.11 10 41.1 1.91 10 41.1 1.73 10 38.1 4.56 10 54.9 1.64 10 56.6 2.40 10 56.3 2.32 10 56.2 1.96 10 54.0 1.25 10 19.6 .60 1 19.7 .94 10 19.7 .89 10 19.5 .83 10 19.2 .46 10 35.7 .31 10 1009 80.9 10 34.7 * .42 10 908 99.0 10 34.9 * .45 10 851 * 101.9 10 34.7 * .40 10 837 * 85.9 10 35.5 .29 10 1023 113.7 10 C o v a n ce 3MS 3T2 9-S-128935 TZZZOO 002232 Table 10 Summary of Clinical Hematology Data Females Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE WBC ppm T 6295 XIOV^L N-SEG LYMPH XIOV/JL X103/fih MONO EOSIN BASO XIOVliL XIO'/^L XIOViiL N-SEG% LYMPH% MONO% EOSIN% C ov a nce 3m632T9- -183 6295 BASO% 0 MEAN 4.2 1.6 1.9 .5 .1 .0 37 49 12 2 0 S.D. 1.72 1.16 .57 .16 .00 .00 10.5 8.8 3.2 .8 .0 N 10 1 10 10 10 10 10 10 10 10 10 0.5 MEAN 4.7 1.0 3.1 * .5 .1 .0 22 * 64 * 12 2 0 S.D. 1.53 .28 1.27 .20 .03 .00 4.7 7.2 4.6 .8 .3 N 10 10 10 10 10 10 10 10 10 10 10 2.0 MEAN 5.2 1.5 3.1 * .5 .1 .0 28 59 10 3 0 S.D. 1.28 .54 .94 .16 .05 .00 7.4 8.6 2.5 .7 ,0 N 10 10 10 10 10 10 10 10 10 10 10 5.0 MEAN 4.2 1.2 2.5 .5 .1 .0 27 60 11 2 0 S.D. 1.27 .58 .70 .19 .04 .00 8.2 8.2 3.9 .8 .3 N 10 10 10 10 10 10 10 10 10 10 10 20.0 MEAN 5.4 2.1 2.6 .5 .1 .0 34 53 10 2 0 S.D. 2.33 1.94 .90 .27 .04 .00 17.1 17.6 2.5 1.0 4 N 10 10 10 10 10 10 10 10 10 10 10 T able 11 Males Week 4 EK DIETARY^CHR0NIC^TOXICITY^AND^CARCIN0G^IciTY^STOl)Y^Wira^PERFLU0ROOCTANE DOSE GLU T-6295 MG/DL UN MG/DL GREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL MEAN S.D. N 0.5 MEAN S.D. N 2.0 mean S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 97 11.4 10 97 5.2 10 91 10.8 10 94 8.9 10 84 * 5.0 10 12 1.2 10 12 1.8 10 12 1.3 10 12 2.1 10 13 1.5 10 .6 .18 10 .6 .06 10 .6 .14 10 .6 .10 10 .6 .12 10 6.2 .43 10 6.4 .33 10 6.0 .33 10 6.3 .29 10 6.3 .23 10 4.4 .26 10 4.6 .29 10 4.5 .29 10 4.6 .19 10 4.6 .18 10 1.8 -32 10 1.8 .31 10 1.6 .16 10 1.7 .15 10 1.7 .13 10 .1 .09 10 .1 -09 10 .1 .08 10 .0 .05 10 .1 .09 10 49 6.6 10 49 6.5 10 44 8.6 10 48 15.3 10 45 13.7 10 Covance 6329-183 3M T-6295 002233 Table 11 Summary of Clinical Chemistry Data Hales Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE AST/SGOT ALT/SGPT ppm 6295 IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L 0 0.5 2.0 5.0 20.0 MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 122 26.4 10 146 28.9 10 104 22.6 10 114 17.2 10 131 19.9 10 31 3.4 10 32 4.2 10 28 5.2 10 30 3.8 10 33 3.0 10 1 1.3 10 10.7 .41 10 0 .7 10 10.7 .31 10 1 1.6 10 10.6 .41 10 0 .7 10 10.9 .28 10 1 1.3 10 10.6 .31 10 10.0 .54 10 9.5 .62 10 10.1 .39 10 9.8 .62 10 9.8 .59 10 148 1.6 10 147 1.3 10 148 1.4 10 147 1.4 10 148 1.4 10 6.3 .69 10 6.3 .42 10 6.2 .71 10 6.2 .62 10 6.1 .58 10 104 1 10 104 1 10 105 1 10 103 2 10 103 10 C o v a n c e 3M6 3T2 9- -6128935 002234 Table 11 Summary of clinical Chemistry Data Females Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE GLU ppm T--6295 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 .7 6.9 5.1 1.8 .1 72 S.D. 7.1 1.7 .10 .14 .11 .16 .10 11.5 N 10 10 10 10 10 10 10 10 0.5 MEAN 111 13 .8 6.8 5.0 1.8 .0 70 S.D. 7.0 1.8 .09 .16 .18 .23 .07 25.8 N 10 10 10 10 10 10 10 10 2.0 MEAN 113 14 .8 6.8 5.1 1.7 .0 61 S.D. 17.9 1.8 .13 .39 .32 .19 .07 17.7 N 10 10 10 10 10 10 10 10 5.0 MEAN 109 13 .7 7.1 5.3 1.8 .0 58 S.D. 11.0 1.2 .08 .35 .31 .17 .04 14.8 N 10 10 10 10 10 10 10 10 20.0 MEAN 107 14 .7 6.8 5.2 1.6 .0 54 S.D. 7.7 1.8 .10 .35 .19 .18 .10 10.7 N 10 10 10 10 10 10 10 10 C o v a n ce 3M6 3T2 9- -6128935 002235 Table 11 Summary o clinical Chemistry Data Females Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE AST/SGOT ALT/SGPT ppm ' 6295 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 O.S MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 123 28.2 10 120 37.2 10 101 12.2 10 112 23.9 10 92 * 16.0 10 32 4.8 10 31 5.6 10 29 5.6 10 32 5.1 10 32 7.1 10 0 .7 10 10.8 .34 10 1 1.4 10 10.6 .31 10 2 2.0 10 10.7 .37 10 2 1.3 10 10.7 .35 10 1 1.1 10 10.6 .24 10 8.5 .90 10 8.4 1.03 10 8.5 1.08 10 7.9 .83 10 8.2 1.47 10 145 1.0 10 145 .8 10 147 1.3 10 147 2.2 10 146 1.8 10 5.9 .43 10 6.1 .45 10 6.2 .51 10 6.1 .41 10 6.0 .56 10 104 1 10 104 10 106 1 10 105 1 10 105 1 10 Covanc e 3M63T29- -183 6295 002236 Table 11 Summary of Clinical Chemistry Data Males Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE PCOAO ppm T-6295 IU/G 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 9 2.2 5 9 2.3 5 7 4.0 5 8 .8 5 6 1.4 5 C o v a n c e 3M6 3T2 9- 6- 128935 002237 Table 11 Summary of Clinical Chemistry Data Females Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE PCOAO ppm T-6295 IU/G 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 5 1.5 5 6 1.1 5 3 1.7 5 2* 1.1 5 4 1.1 5 C o v a n c e 3M6 3T2 9- 6- 128935 002238 Table 12 Summary of Clinical Chemistry Data Males Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE GLU ppm T--6295 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 102 13 .4 6.9 4.9 2.0 .2 63 S.D. 6.5 1.8 .14 .41 .26 .30 .18 13.4 N 10 10 10 10 10 10 10 10 0.5 MEAN 106 14 .6 7.0 5.0 2.0 .2 53 S.D. 11.2 1.6 .14 .34 .20 .26 .15 16.6 N 10 10 10 10 10 10 10 10 2.0 MEAN 91 13 .5 6.7 4.7 2.0 .1 51 S.D. 13.7 2.0 .10 .34 .16 .25 .12 14.5 N 10 10 10 10 10 10 10 10 5.0 MEAN 99 14 .6 7.0 4.9 2.1 .2 57 S.D. 8.9 1.4 .12 .46 .29 .20 .15 6.9 N 10 10 10 10 10 10 10 10 20.0 MEAN 95 16 * .6 6.9 4.9 2.0 .1 37 * S.D. 10.3 1.6 .16 .34 .24 .18 .13 12.9 N 10 10 10 10 10 10 10 10 Covance3M63T29-6-128935 002239 Table 12 Summary of Clinical Chemistry Data Hales Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-629S) IN RATS DOSE AST/SGOT ALT/SGPT ppm ' -6295 IU/L IU/L GGT IU/L CA MG/DL I: p h o s MG/DL NA MMOL/L K MMOL/L CL MMOL/L 0 0.5 2.0 5.0 20.0 MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 111 23.1 10 112 18.8 10 127 20.5 10 129 15.4 10 128 60.7 10 36 7.0 10 41 6.3 10 41 4.7 10 44 13.6 10 65 * 52.9 10 1 1.5 10 10.5 .28 10 1 .7 10 10.5 .29 10 1 1.3 10 10.4 .20 10 1 1.6 10 10.5 .31 10 1 1.6 10 10.5 .23 10 7.5 .57 10 7.8 .64 10 7.8 .64 10 7.5 .57 10 7.8 .58 10 146 .7 10 147 2.6 10 147 1.8 10 147 2.8 10 146 1.3 10 6.2 .37 10 6.5 .32 10 6.4 .46 10 6.1 .37 10 6.4 .52 10 105 1.2 10 105 2.0 10 105 2.2 10 104 2.0 10 104 1.4 10 C ov an c e3M632T9- -183 6295 002240 Table 12 Summary of Clinical Chemistry Data Females Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE GLU ppm T--6295 MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 106 12.0 10 106 9.1 10 108 5.9 10 95 * 8.3 10 99 6.7 10 15 1.7 10 15 3.2 10 15 2.3 10 15 2.0 10 18 * 2.5 10 .6 .12 10 .6 .13 10 .8 * .12 10 .6 .14 10 .6 .05 10 7.6 .34 10 8.2 * .42 10 7.9 .30 10 8.0 .44 10 8.0 .45 10 5.6 .25 10 6.2 * .44 10 5.9 .24 10 5.9 .43 10 6.1 * .33 10 2.1 .22 10 2.0 .19 10 2.0 .22 10 2.1 .31 10 1.9 .19 10 .1 75 .19 14.9 10 10 .2 88 .14 .27.1 10 10 .1 87 .08 23.9 10 10 .2 70 .14 13.4 10 10 .2 66 .14 14.0 10 10 C o v a n ce 3M6 3T2 9-6- 128935 002241 Table 12 Summary of clinical Chemistry Data Females Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE AST/SGOT ALT/SGPT ppm ' 6295 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 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N 103 16.3 10 107 17.8 10 103 26.9 10 103 16.5 10 90 20.7 10 34 2.4 10 36 9.1 10 37 17.9 10 34 4.7 10 39 18.2 10 1 1.2 10 1 1.7 10 1 1.4 10 2 1.9 10 1 1.5 10 10.7 .45 10 11.1 .49 10 10.9 .43 10 10.7 .51 10 10.8 .30 10 6.3 .95 10 6.4 1.30 10 6.5 .87 10 6.6 1.14 10 6.5 .77 10 148 2.0 10 148 2.1 10 148 3.0 10 148 2.8 10 148 2.6 10 6.0 .43 10 6.4 .76 10 6.2 .71 10 5.8 .72 10 6.2 .57 10 107 .9 10 106 1.6 10 105 1.4 10 107 1 10 106 3 10 Co van ce3M63T29- -183 6295 002242 Table 12 Summary of Clinical Chemistry Data Males Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE PCOAO ppm T-6295 IU/G 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N 5 1.3 5 5 3.3 5 5 3.0 5 2 1.8 5 5 1.9 5 C o v a n c e 3M6 3T2 9- 6- 128935 002243 Table 12 Summary of Clinical Chemistry Data Females Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE PCOAO ppm T-6295 IU/G 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 2 1.6 5 3 2.4 5 1 .7 5 2 2.6 5 5 2.9 5 Covance3M63T29-6-128935 o O T able 13 Summary of Clinical Chemistry Data Hales Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE GLU ppm T--6295 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 12 .7 7.3 4.9 2.4 .2 89 S.D. 8.1 2.3 .10 .43 .28 .34 .12 24.7 N 10 10 10 10 10 10 10 10 0.5 MEAN 117 13 .8 7.1 4.7 2.4 .3 84 S.D. 14.7 1.7 .16 .48 .30 .33 .06 31.8 N 10 10 10 10 10 10 10 10 2.0 MEAN 114 13 .8 7.2 4.8 2.4 .4 74 S.D. 13.2 2.3 .08 .29 .23 .26 .16 15.5 N 10 10 10 10 10 10 10 10 5.0 MEAN 113 14 .7 7.4 4.9 2.5 .3 72 S.D. 11.7 2.5 .16 .45 .28 .24 .12 28.2 N 10 10 10 10 10 10 10 10 20.0 MEAN 111 17 * .8 7.5 5.1 2.4 .2 46 * S.D. 12.8 2.1 .15 .34 .25 .19 .10 11.6 N 10 10 10 10 10 10 10 10 C o v a n c e3M6 3T2 9- 6- 128935 00245 Table 13 Summary of Clinical Chemistry Data Hales Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE AST/SGOT ALT/SGPT ppm ' 6295 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 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 84 17.8 10 81 13.0 10 92 22.0 10 80 9.7 10 103 53.6 10 37 6.2 10 36 6.1 10 47 10.5 10 38 6.3 10 65 48.7 10 1 1.3 10 11.1 .36 10 2 1.8 10 11.1 .43 10 1 .6 10 11.1 .28 10 1 1.4 10 11.3 .57 10 1 1.9 10 11.2 .34 10 6.7 .36 10 6.9 .59 10 6.8 .30 10 7.1 .62 10 7.3 .92 10 146 1.1 10 147 1.8 10 147 1.9 10 148 1.9 10 147 2.5 10 6.7 .23 10 7.0 .53 10 6.7 .54 10 6.9 .46 10 6.9 .65 10 104 2 10 104 1 10 104 1 10 104 1 10 104 1 10 C o van ce3M63T29- -183 6295 002246 T able 13 Summary of Clinical Chemistry Data Females Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE GLU ppm T-6295 MG/DL UN MG/DL CREAT MG/DL T PRO G/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 104 7.3 10 98 6.3 10 99 8.2 10 98 10.0 10 94 6.8 10 14 1.3 10 15 2.1 10 15 1.9 10 15 3.2 10 20 * 2.8 10 .9 .17 10 .9 .21 10 1.0 .16 10 .9 .14 10 .9 .13 10 8.9 .37 10 8.4 .66 10 8.4 .71 10 8.3 .39 10 8.7 .55 10 6.4 .41 10 6.2 .59 10 6.0 .65 10 5.9 .28 10 6.4 .37 10 2.5 .20 10 2.3 .29 10 2.4 .26 10 2.3 .29 10 2.3 .31 10 .4 115 .14 26.0 10 10 .3 95 .10 29.0 10 10 .3 78 * .13 16.3 10 10 .3 79 * .15 10.9 10 10 .4 80 * .14 24.4 10 10 Covance3M63T29-6-128935 002247 T able 13 Summary of Clinical chemistry Data Females Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE AST/SGOT ALT/SGPT 6295 IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L MMOL/L CL MMOL/L MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 119 71.9 10 102 18.6 10 143 116.7 10 117 39.6 10 117 62.6 10 64 49.4 10 34 8.4 10 77 130.6 10 47 25.8 10 64 55.5 10 2 2.0 10 2 1.5 10 2 2.0 10 4 1.7 10 2 2.6 10 11.7 .34 10 11.7 .67 10 11.2 * .38 10 11.2 .37 10 11.5 .44 10 6.7 .77 10 6.5 .74 10 6.4 .96 10 6.7 .75 10 7.3 1.20 10 148 2.1 10 147 2.2 10 148 2.4 10 148 1.9 10 148 2.9 10 5.8 .71 10 5.9 .69 10 5.8 .57 10 6.0 .63 10 6.0 .67 10 106 2 10 106 1 10 107 1 10 108 2 10 106 2 10 Covane3M63T29-6-128935 ao ci O O 002249 Table 14 Summary of Clinical Chemistry Data Males Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE AST/SGOT ALT/SGPT ppm T-6295 IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L C o v a n c e 3M6 3T2 9- 6- 128935 MEAN S.D. N MEAN S.D. N MEAN S.D. N 20.0 MEAN S.D. N MEAN S.D. N 106 27.0 10 118 38.8 10 111 16.6 10 130 21.9 10 129 70.0 9 54 65.8 10 62 * 51.8 10 40 7.5 10 44 8.3 10 83 * 84.4 9 0 .0 10 10.5 .39 10 0 .5 10 11.4 * .41 10 0 .8 10 11.0 * .43 10 0 1.3 10 11.1 * .55 10 1 10.5 1.3 .41 99 6.3 .42 10 7.1 * .34 10 7.2 * .59 10 7.7 * .64 10 7.0 * .61 9 147 1.6 10 148 2.5 10 149 2.4 10 149 3.5 10 148 3.5 9 5.9 .44 10 6.5 .55 10 6.6 .56 10 6.8 * .63 10 6.2 .89 9 106 1.8 10 106 1.9 10 107 1.7 10 107 2.4 10 110 * 2.1 9 Table 14 Summary of Clinical Chemistry Data Females Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE AST/SGOT ALT/SGPT ppm T-6295 IU/L IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L MMOL/L CL MMOL/L MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 119 61.0 10 115 15.3 10 121 21.4 10 108 25.1 10 93 17.5 10 50 30.2 10 43 7.1 10 54 14.5 10 46 19.5 10 46 17.3 10 0 .3 10 10.6 .54 10 0 .5 10 11.1 * .48 10 1 1.3 10 10.8 .24 10 1 1.7 10 11.0 .29 10 0 .3 10 10.6 .47 10 5.8 .90 10 5.8 .83 10 5.6 .58 10 5.5 .74 10 5.9 .65 10 146 2.4 10 147 3.6 10 147 2.1 10 147 1.8 10 147 3.1 10 5.1 .47 10 5.8 1.04 10 5.1 .45 10 5.4 .65 10 5.3 1.00 10 106 2 10 106 3 10 107 2 10 108 3 10 110 2 10 C ova nce 3M63T29- -183 6295 002250 Table 14 Summary of Clinical Chemistry Data Hales Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE GLU ppm T--6295 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 129 10 .6 7.0 4.4 2.6 S.D. 13.2 1.4 .17 .46 .35 .33 N 10 10 10 10 10 10 0.5 MEAN 125 12 .7 7.4 4.8 2.6 S.D. 12.5 1.2 .09 .26 .26 .28 N 10 10 10 10 10 10 2.0 MEAN 121 12 * .7 7.3 4.7 2.6 S.D. 13.8 1.5 .15 .38 .20 .32 N 10 10 10 10 10 10 5.0 MEAN 121 14 * .7 7.6 * 4.8 2.7 S.D. 8.0 1.3 .16 .46 .28 .32 N 10 10 10 10 10 10 20.0 MEAN 110 * 13 * .7 7.0 4.6 2.4 S.D. 10.2 2.3 .09 .61 .55 .23 N 999999 .0 120 .07 44.6 10 10 .2 129 .16 53.1 10 10 .1 89 .09 17.7 10 10 .1 92 .12 15.2 10 10 .0 50 * .03 17.8 99 c o v a n c e 3M6 3T2 9- 6- 128935 002251 Table 14 Summary of Clinical Chemistry Data Females Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE GLU ppm T--6295 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 111 11 .7 7.7 5.5 2.2 S.D. 10.1 2.5 .10 1.04 .81 .38 N 10 10 10 10 10 10 0.5 MEAN 102 13 .7 8.1 5.8 2.3 S.D. 8.4 2.3 .25 .44 .34 .19 N 10 10 10 10 10 10 2.0 MEAN S.D. N 96 * 13 .8 8.0 5.5 2.5 12.9 2.2 .15 .45 .44 .46 10 10 10 10 10 10 5.0 MEAN S.D. N 97 * 14 * .8 8.2 5.8 2.4 6.3 2.9 .19 .31 .32 .30 10 10 10 10 10 10 20.0 MEAN S.D. N 98 * 16 * .8 7.9 5.7 2.2 9.8 2.8 .14 .76 .81 .39 10 10 10 10 10 10 .0 116 .07 19.8 10 10 .2 108 .14 26.1 10 10 .1 101 .11 17.2 10 10 .1 110 .13 49.6 10 10 .0 79 .10 25.5 10 10 C o v a n c e 3M6 3T2 9- 6- 128935 002252 Table 15 Summary of Clinical Urinalysis Data Males Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-5295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 21.4 11.72 10 22.6 14.76 10 25.3 16.35 10 31.8 14.52 10 22.6 9.78 10 1.010 .0036 10 1.014 .0080 10 1.010 .0073 10 1.009 .0055 10 1.012 .0069 10 7.0 .16 10 7.0 .24 10 7.0 .33 10 7.2 .24 10 7.0 .00 10 Covance3MS3T29-6-128935 002253 Table 15 Summary of Clinical Urinalysis Data Females Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 10.9 13.48 10 15.2 16.13 10 14.2 17.68 10 13.2 7.12 10 17.5 16.39 10 1.019 .0103 10 1.015 .0106 10 1.015 .0087 10 1.014 .0060 10 1.013 .0083 10 6.8 .26 10 6.8 .24 10 6.8 .26 10 6.8 .24 10 6.8 .26 10 C o v a n ce 3M6 3T2 9-6- 128935 002254 Table 16 Summary of Clinical Urinalysis Data Males Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 28.8 16.45 10 23.5 16.23 10 20.8 17.37 10 25.4 14.27 10 18.5 14.64 10 1.014 .0099 10 1.018 .0140 10 1.018 .0099 10 1.014 .0067 10 1.019 .0073 10 7.2 .34 10 7.1 .39 10 7.0 .37 10 7.0 .33 10 7.0 .28 10 C o v a n c e 3H6 3T2 9- 6- 128935 0022S5 Table 16 Summary of Clinical Urinalysis Data Females Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 17.5 21.04 10 16.8 17.86 10 7.8 6.43 10 25.7 14.20 10 19.5 17.83 10 1.020 .0166 10 1.016 .0090 10 1.021 .0082 10 1.009 .0050 10 1.015 .0119 10 6.8 .26 10 7.0 .50 10 6.8 .35 10 6.8 .35 10 6.9 .32 10 C o v a n c e 3M6 3T2 9- -6128935 9SZZ00 T able 17 Summary of Clinical Urinalysis Data Hales Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N 15.2 7.12 10 16.2 8.42 10 16.2 6.79 10 20.4 15.70 10 17.9 16.42 10 1.022 .0105 10 1.017 .0056 10 1.019 .0053 10 1.019 .0107 10 1.029 .0231 10 6.9 .32 10 7.1 .21 10 7.0 .37 10 7.0 .24 10 6.8 .26 10 Covance3M63T29-6-128935 002257 Table 17 Summary of Clinical Urinalysis Data Females Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N 17.6 17.05 10 15.9 12.34 10 15.6 12.72 10 21.6 14.18 10 13.7 11.58 10 1.016 .0142 10 1.016 .0089 10 1.016 .0092 10 1.014 .0104 10 1.022 .0170 10 6.6 .21 10 6.6 .34 10 6.8 .24 10 6.9 .32 10 6.6 .37 10 Covance3M63T29-6-128935 002258 Table 18 Summary o Clinical Urinalysis Data Males Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N MEAN S.D. N 12.5 7.75 10 18.0 13.20 10 16.2 7.90 10 11.6 7.53 10 11.0 4.55 9 1.025 .0110 10 1.026 .0123 10 1.021 .0063 10 1.032 .0182 10 1.028 .0074 9 6.6 .32 10 6.7 .26 10 7.1 .42 9 6.9 .39 10 6.9 .49 9 C o v a n c e 3M6 3T2 9- -6128935 002259 Table 18 Summary of Clinical Urinalysis Data Females Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 9.1 2.00 10 7.7 4.07 10 9.0 5.46 10 8.3 12.54 10 10.1 13.35 10 1.022 .0039 10 1.025 .0070 10 1.025 .0114 10 1.030 .0105 10 1.028 .0117 10 6.5 .33 10 6.6 .52 10 6.5 .33 10 6.6 .41 10 6.2 .26 10 Covance3H63T29-6-128935 092200 Table 18 Summary of Clinical Urinalysis Data Males Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N MEAN S.D. N 12.5 7.75 10 18.0 13.20 10 16.2 7.90 10 11.6 7.53 10 11.0 4.55 9 1.025 .0110 10 1.026 .0123 10 1.021 .0063 10 1.032 .0182 10 1.028 .0074 9 6.6 .32 10 6.7 .26 10 7.1 .42 9 6.9 .39 10 6.9 .49 9 Covance3M63T29-6-128935 002261 Table 18 Summary of clinical Urinalysis Data Females Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U VOL ppm T-6295 ML SP GR U PH 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N 9.1 2.00 10 7.7 4.07 10 9.0 5.46 10 8.3 12.54 10 10.1 13.35 10 1.022 .0039 10 1.025 .0070 10 1.025 .0114 10 1.030 .0105 10 1.028 .0117 10 6.5 .33 10 6.6 .52 10 6.5 .33 10 6.6 .41 10 6.2 .26 10 Covance3M63T29-6-128935 002262 Table 19 Summary of Urine Chemistry Data Males Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U NA ppm T-6295 MMOL/L U K NA EXC MMOL/L MMOL K EXC MMOL 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 12 3.5 10 19 13.9 10 13 9.5 10 14 7.9 10 17 16.4 10 65 20.2 10 86 53 .4 10 65 42.5 10 54 32.0 10 68 39.1 10 .22 .092 9 .29 .096 9 .24 .114 7 .40 .186 7 .28 .086 10 1.18 .258 9 1.35 .191 9 1.18 .211 7 1.47 .289 7 1.23 .175 10 C o van ce 3M6 3T2 9-6-128935 002263 Table 19 Summary of Urine Chemistry Data Females Week 4 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U NA ppm T-6295 MMOL/L U K NA EXC MMOL/L MMOL K EXC MMOL 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 22 10.6 10 23 18.0 10 28 16.7 10 22 12.2 10 20 12.3 10 103 59.9 10 86 74.1 10 80 43.9 10 70 34.1 10 67 40.2 10 .13 .049 9 .15 .071 8 .20 .069 8 .24 * .076 10 .18 .048 8 .56 .198 9 .59 .152 8 .57 .198 8 .75 .222 10 .66 .130 8 C o v a n c e 3M6 3T2 9-6- 1289 35 002264 Table 20 Summary of Urine chemistry Data Females Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U NA ppm T-6295 MMOL/L U K NA EXC MMOL/L MMOL K EXC MMOL 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 20.0 MEAN S.D. N MEAN S.D. N 32 23.2 9 27 17.6 10 43 21.2 10 16 9.1 10 37 40.5 10 77 53.0 9 70 43.6 10 106 44.1 10 42 25.2 10 69 68.9 10 .22 .058 6 .20 .065 8 .26 .146 10 .31 .085 8 .35 .197 8 .54 .172 6 .56 .212 8 .63 .234 10 .88 .281 8 .65 .259 8 Covance3M63T29-6-128935 002265 T able 20 Summary of Urine Chemistry Data Males Week 14 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U NA ppm T-6295 MMOL/L U K NA EXC MMOL/L MMOL K EXC MMOL 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 20 17.1 10 25 16.5 10 23 12.5 10 22 11.7 10 26 13.2 10 60 50.1 10 87 80.7 10 82 56.0 10 65 34.8 10 89 37.8 10 .43 .255 7 .38 .165 8 .33 .180 8 .44 .104 8 .37 .182 10 1.17 .294 7 1.13 .314 8 1.01 .372 8 1.33 .226 8 1.24 .438 10 C o v a n c e 3M6 3T2 9- 6- 128935 0ollhh Table 21 Summary of Urine Chemistry Data Females Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U NA ppm T-6295 MMOL/L U K NA EXC MMOL/L MMOL K EXC MMOL 0 0.5 2.0 5.0 20.0 MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 18 18.0 10 14 9.9 10 21 18.1 10 18 17.2 10 32 37.4 10 71 68.2 10 74 50.2 10 70 49.9 10 67 56.7 10 96 85.7 10 .14 .070 8 .16 .055 9 .19 .083 10 .22 .139 9 .21 .119 10 .58 .241 8 .79 .212 9 .66 .158 10 .84 .280 9 .73 .270 10 C o v a n c e 3M6 3T2 9- 6- 128935 002267 Table 21 Summary of Urine Chemistry Data Males Week 27 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U NA pprn T-6295 MMOL/L U K NA EXC MMOL/L MMOL K EXC MMOL 0 MEAN S.D. N 0.5 MEAN S.D. N 2.0 MEAN S.D. N 5.0 MEAN S.D. N 20.0 MEAN S.D. N 22 14.5 10 16 10.0 10 24 9.9 9 21 15.5 10 46 42.4 10 116 67.1 10 77 28.1 10 93 25.3 9 89 65.7 10 139 114.5 10 .29 .153 10 .22 .098 10 .35 .192 9 .30 .122 8 .41 .226 8 1.43 .422 10 1.10 .234 10 1.27 .333 9 1.22 .394 8 1.31 .532 8 C o v a n c e 3M6 3T2 9- 6- 128935 002268 Table 22 Summary of Urine Chemistry Data Males Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U NA ppm T-6295 MMOL/L U K NA EXC MMOL/L MMOL K EXC MMOL 0 0.5 2.0 5.0 20.0 MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 32 15.5 10 23 18.2 10 21 11.4 10 32 21.5 10 46 20.0 9 133 65.6 10 144 103.4 10 96 30.6 10 168 105.3 10 145 36.4 9 .34 .141 10 .27 .158 9 .31 .168 10 .27 .115 10 .49 .215 9 1.30 .390 10 1.65 .354 9 1.40 .401 10 1.41 .228 10 1.51 .473 9 C o v a n ce 3M6 3T2 9-6- 128935 002269 Table 22 Summary of Urine Chemistry Data Females Week 53 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN RATS DOSE U NA ppm T-6295 MMOL/L U K NA EXC MMOL/L MMOL K EXC MMOL 0 MEAN S.D. N MEAN S.D. N 2.0 MEAN S.D. N MEAN S.D. N 20.0 MEAN S.D. N 40 14.8 10 28 13.6 10 23 * 8.8 10 37 14.5 10 42 22.7 10 135 42.4 10 132 51.3 10 140 69.9 10 172 80.9 10 164 85.4 10 .36 .122 10 .22 .163 10 .18 .081 10 .21 .147 10 .26 .186 9 1.19 .337 10 .87 * .278 10 .99 .307 10 .76 * .239 10 .93 .226 9 C o v a n c e 3M6 3T2 9- 6- 128935 002270 TABLE 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2 ;SUBSET=ALL LF ADRENAL SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (9) 5 495.5 55.9 ORGAN WEIGHT (9) . 5 0.0331 0.0016 ORGAN-TOBODY WT <%> 5 0.0068 0.0010 ORGAN-TOBRAIN WT RATIO 5 0.0151 0.0011 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (9) 5 284.0 39.2 5 0.0443 0.0073 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 0.0296 0.0071 5 0.0061 0.0011 5 0.0133 0.0032 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 0.0346 0.0062 M3 NUMBER IN GROUP MEAN STANDARD DEV 5 434.1 31.4 5 0.0305 0.0082 5 0.0071 0.0023 5 0.0133 0.0032 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 5 0.0383 0.0060 Covance 6329 -183 3m t -6295 PAGE: 1 ORGAN-TOBODY WT (%) ORGAN-TO BRAIN WT RATIO 5 0.0159 0.0038 5 0.0217 0.0042 5 0.0115 0.0009 5 0.0166 0.0034 5 0.0146 0.0034 5 0.0189 0.0028 002271 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2 ;SUBSET=ALL LF ADRENAL SEX DOSE GROUP M4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (9) 5 524.2 44.5 ORGAN WEIGHT (g) 5 0.0330 0.0063 ORGAN-TOBODY WT (%) 5 0.0063 0.0008 ORGAN-TOBRAIN WT RATIO 5 0.0146 0.0034 SEX DOSE GROUP F4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 246.7 17.5 5 0.0355 0.0072 M5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 470.3 40.1 5 0.0250 0.0032 5 0.0053 0.0004 5 0.0114 0.0005 F5 NUMBER IN GROUP MEAN STANDARD DEV 5 249.1 26.1 5 0.0345 0.0043 C o v a n c e 3M6 3T2 9-6- 128935 PAGE: 2 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.0144 0.0026 5 0.0172 0.0037 5 0.0140 0.0024 5 0.0172 0.0035 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 3M63T29-6-128935 PAGE: 3 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2 ;SUBSET=ALL RT ADRENAL SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (9) 5 495.5 55.9 ORGAN WEIGHT (g) . 5 0.0302 0.0051 ORGAN-TOBODY WT (%) 5 0.0062 0.0013 ORGAN-TOBRAIN WT RATIO 5 0.0137 0.0021 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT <%) ORGAN-TOBRAIN WT RATIO 5 284.0 39.2 5 0.0417 0.0093 5 0.0150 0.0043 5 0.0204 0.0050 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 0.0247 0.0094 5 0.0051 0.0016 5 0.0112 0.0043 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 0.0322 0.0056 5 0.0108 0.0013 5 0.0154 0.0028 M3 NUMBER IN GROUP MEAN STANDARD DEV 5 434.1 31.4 5 0.0286 0.0079 5 0.0066 0.0019 5 0.0126 0.0034 F3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 265.7 16.3 5 0.0373 0.0052 5 0.0141 0.0025 5 0.0184 0.0022 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL RT ADRENAL SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 524.2 44.5 ORGAN WEIGHT <g> . 5 0.0318 0.0072 ORGAN-TOBODY WT (%) 5 0.0060 0.0010 ORGAN-TOBRAIN WT RATIO 5 0.0140 0.0032 SEX DOSE GROUP F4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 246.7 17.5 5 0.0329 0.0042 M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 5 0.0253 0.0044 5 0.0054 0.0009 5 0.0115 0.0012 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 249.1 26.1 5 0.0323 0.0052 Covance 6329-183 3M T-6295 PAGE; 4 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.0133 0.0013 5 0.0159 0.0018 5 0.0131 0.0028 5 0.0161 0.0041 002274 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL BRAIN SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 495.5 55.9 ORGAN WEIGHT (g) . 5 2.2027 0.0998 ORGAN-TOBODY WT (%) 5 0.4499 0.0620 ORGAN-TOBRAIN WT RATIO 5 1.0000 0.0000 SEX DOSE GROUP F1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 284.0 39.2 5 2.0506 0.0895 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 2.2216 0.1022 5 0.4652 0.0408 5 1.0000 0.0000 F2 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 298.9 40.8 5 2.0992 0.1878 M3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 434.1 31.4 5 2.2768 0.0980 5 0.5280 0.0621 5 1.0000 0.0000 F3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 265.7 16.3 5 2.0240 0.0532 Covance 6329-183 3M T-6295 PAGE: 5 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.7302 0.0796 5 1.0000 0.0000 5 0.7123 0.1139 5 1.0000 0.0000 5 0.7647 0.0623 5 1.0000 0.0000 002275 002276 T able 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329 -183 3M T- 6295 PAGE: 6 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL BRAIN SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 524.2 44.5 ORGAN WEIGHT (g) . 5 2.2740 0.1332 ORGAN-TOBODY WT (%) 5 0.4366 0.0471 ORGAN-TOBRAIN WT RATIO 5 1.0000 0.0000 SEX DOSE GROUP F4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 246.7 17.5 5 2.0631 0.0817 5 0.8388 0.0509 5 1.0000 0.0000 M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 5 2.1876 0.2136 5 0.4655 0.0318 5 1.0000 0.0000 F5 NUMBER IN GROUP MEAN STANDARD DEV 5 249.1 26.1 5 2.0375 0.2129 5 0.8187 0.0414 5 1.0000 0.0000 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2 ;SUBSET=ALL LF KIDNEY SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 495.5 55.9 ORGAN WEIGHT (g) 5 1.9158 0.2630 ORGAN-TOBODY WT (%) 5 0.3867 0.0350 ORGAN-TOBRAIN WT RATIO 5 0.8733 0.1428 SEX DOSE GROUP F1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) 5 284.0 39.2 ORGAN WEIGHT (g) 5 1.1576 0.1245 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 1.8856 0.2315 5 0.3920 0.0241 5 0.8470 0.0779 F2 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 298.9 40.8 5 1.1245 0.1201 M3 NUMBER IN GROUP MEAN STANDARD DEV 5 434.1 31.4 5 1.8856 0.1583 5 0.4356 0.0413 5 0.8295 0.0808 F3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 265.7 16.3 5 1.1610 0.0565 Covance 6329-183 3M T-6295 PAGE: 7 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.4123 0.0616 5 0.5650 0.0618 5 0.3787 0.0384 5 0.5385 0.0695 5 0.4377 0.0231 5 0.5741 0.0345 002277 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2;SUBSET=ALL LF KIDNEY SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 524.2 44.5 ORGAN WEIGHT (g) 5 2.0510 0.2638 ORGAN-TOBODY WT (%) 5 0.3919 0.0448 ORGAN-TOBRAIN WT RATIO 5 0.9034 0.1208 SEX DOSE GROUP F4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) 5 246.7 17.5 ORGAN WEIGHT (g) 5 1.1187 0.1230 M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 5 1.9496 0.1517 5 0.4174 0.0525 5 0.9001 0.1341 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 249.1 26.1 5 1.1562 0.0619 Covance 6329-183 3M T-6295 PAGE: 8 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.4531 0.0345 5 0.5420 0.0551 5 0.4675 0.0456 5 0.5708 0.0446 002278 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2 ;SUBSET=ALL RT KIDNEY SEX DOSE GROUP M1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (9) 5 495.5 55.9 ORGAN WEIGHT (g) 5 1.8989 0.1660 ORGAN-TOBODY WT <%) 5 0.3849 0.0314 ORGAN-TOBRAIN WT RATIO 5 0.8647 0.0988 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (9) ORGAN WEIGHT (g) 5 284.0 39.2 5 1.1863 0.1066 M2 NUMBER IN GROUP : MEAN: STANDARD DEV: 5 481.0 51.3 5 1.8373 0.1452 5 0.3834 0.0238 5 0.8262 0.0350 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 1.1307 0.1396 M3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 434.1 31.4 5 1.9428 0.1201 5 0.4487 0.0321 5 0.8551 0.0730 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 5 1.1545 0.0706 Covance 6329-183 3M T-6295 PAGE: 9 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.4224 0.0567 5 0.5792 0.0548 5 0.3796 0.0294 5 0.5417 0.0788 5 0.4347 0.0131 5 0.5713 0.0472 002279 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL RT KIDNEY SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 524.2 44.5 ORGAN WEIGHT (g) 5 2.0560 0.2362 ORGAN-TOBODY WT (%) 5 0.3930 0.0415 ORGAN-TOBRAIN WT RATIO 5 0.9070 0.1245 SEX DOSE GROUP F4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 246.7 17.5 5 1.1446 0.1468 M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 5 1.9357 0.1823 5 0.4152 0.0634 5 0.8945 0.1506 F5 NUMBER IN GROUP MEAN STANDARD DEV 5 249.1 26.1 5 1.1993 0.0960 Covance 6329-183 3M T-6295 PAGE: 10 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.4626 0.0307 5 0.5543 0.0637 5 0.4844 0.0497 5 0.5914 0.0490 002280 002281 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2 ;SUBSET=ALL LIVER Covance 6329-183 3M T-6295 PAGE: 11 SEX DOSE GROUP M1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT <g) 5 495.5 55.9 5 15.8246 1.1470 ORGAN-TOBODY WT (%) 5 3.2105 0.2501 ORGAN-TOBRAIN WT RATIO 5 7.2089 0.7794 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT <%> ORGAN-TOBRAIN WT RATIO 5 284.0 39.2 5 9.2939 1.5941 5 3.2663 0.2219 5 4.5286 0.6977 M2 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 481.0 51.3 5 15.5356 2.6697 5 3.2119 0.2424 5 6.9828 1.1308 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 9.1934 1.2506 5 3.0785 0.1365 5 4.3942 0.5841 M3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 434.1 31.4 5 14.0264 1.3506 5 3.2296 0.1645 5 6.1829 0.7912 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 5 8.4060 0.6870 5 3.1686 0.2526 5 4.1509 0.2786 002232 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 12 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2 ;SUBSET=ALL LIVER SEX DOSE GROUP M4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 524.2 44.5 5 18.8254 3.0304 ORGAN-TOBODY WT (%) 5 3.5758 0.3075 ORGAN-TOBRAIN WT RATIO 5 8.3121 1.5632 SEX DOSE GROUP F4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 246.7 17.5 5 8.7074 1.0293 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 3.5252 0.2630 5 4.2249 0.5225 M5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 470.3 40.1 5 20.3339* 2.2244 5 4.3329* 0.4281 5 9.3597* 1.3157 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 249.1 26.1 5 10.5929 0.6685 5 4.2760* 0.3527 5 5.2213 0.3041 022S3 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 o PAGE: 13 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL LUNG SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 495.5 55.9 ORGAN WEIGHT <g) 5 1.9239 0.1514 ORGAN-TOBODY WT (%) 5 0.3910 0.0406 ORGAN-TOBRAIN WT RATIO 5 0.8773 0.1103 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 284.0 39.2 5 1.4837 0.1221 5 0.5274 0.0581 5 0.7235 0.0500 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 1.7946 0.1266 5 0.3760 0.0428 5 0.8099 0.0776 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 1.4581 0.0258 5 0.4954 0.0702 5 0.6992 0.0644 M3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 434.1 31.4 5 1.8522 0.2526 5 0.4291 0.0704 5 0.8137 0.1089 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 5 1.2902* 0.1419 5 0.4859 0.0476 5 0.6369 0.0603 0022S4 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 14 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2;SUBSET=ALL LUNG SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (3) 5 524.2 44.5 ORGAN WEIGHT (3) 5 2.6655 1.5011 ORGAN-TOBODY WT (%) 5 0.5072 0.2769 ORGAN-TOBRAIN WT RATIO 5 1.1500 0.5633 SEX DOSE GROUP F4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (3) 5 246.7 17.5 ORGAN WEIGHT (3) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 1.3227* 0.1112 5 0.5390 0.0628 5 0.6420 0.0599 M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 5 1.7721 0.1713 5 0.3767 0.0158 5 0.8107 0.0351 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 249.1 26.1 5 1.2912* 0.1316 5 0.5210 0.0596 5 0.6394 0.0970 002285 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2 ;SUBSET=ALL LF OVARY Covance 6329-183 3M T-6295 PAGE: 15 SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT <g) 5 495.5 55.9 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) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 284.0 39.2 5 0.0807 0.0147 5 0.0292 0.0081 5 0.0394 0.0069 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 0.0707 0.0169 5 0.0235 0.0027 5 0.0339 0.0080 M3 NUMBER IN GROUP MEAN STANDARD DEV 5 434.1 31.4 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 5 0.0674 0.0094 5 0.0254 0.0035 5 0.0333 0.0049 002236 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 16 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2;SUBSET=ALL LF OVARY SEX DOSE GROUP M4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) 5 524.2 44.5 ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) 5 246.7 17.5 ORGAN WEIGHT (g) 5 0.0768 0.0129 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.0311 0.0047 5 0.0371 0.0058 M5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 470.3 40.1 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 249.1 26.1 5 0.0737 0.0164 5 0.0296 0.0056 5 0.0362 0.0068 Table 23 Summary Qf Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329 -183 3M T- 6295 Of) N MO PAGE: 17 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL RT OVARY SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 495.5 55.9 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) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 284.0 39.2 5 0.0731 0.0060 5 0.0261 0.0043 5 0.0358 0.0040 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 0.0700 0.0180 5 0.0233 0.0038 5 0.0333 0.0073 M3 NUMBER IN GROUP MEAN STANDARD DEV 5 434.1 31.4 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 5 0.0707 0.0154 5 0.0266 0.0053 5 0.0349 0.0074 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL RT OVARY SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (9) 5 524.2 44.5 ORGAN WEIGHT <9) ORGAN-TOBODY WT <%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 246.7 17.5 5 0.0769 0.0191 M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 F5 NUMBER IN GROUP MEAN STANDARD DEV 5 249.1 26.1 5 0.0699 0.0086 Covance 6329-183 3M T-6295 PAGE: 18 ORGAN-TOBODY WT <%) ORGAN-TOBRAIN WT RATIO 5 0.0310 0.0066 5 0.0373 0.0094 5 0.0280 0.0012 5 0.0343 0.0018 0022S8 0022S9 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE 19 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2;SUBSET=ALL SPLEEN SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT <g> 5 495.5 55.9 ORGAN WEIGHT (g) 5 0.7759 0.0794 ORGAN-TOBODY WT (%) 5 0.1575 0.0174 ORGAN-TOBRAIN WT RATIO 5 0.3526 0.0364 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 284.0 39.2 5 0.5129 0.0444 5 0.1822 0.0196 5 0.2501 0.0174 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 0.7825 0.1814 5 0.1612 0.0229 5 0.3510 0.0728 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 0.5494 0.1033 5 0.1845 0.0302 5 0.2617 0.0415 M3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 434.1 31.4 5 0.7287 0.0928 5 0.1686 0.0250 5 0.3201 0.0404 F3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 265.7 16.3 5 0.5110 0.0445 5 0.1926 0.0160 5 0.2529 0.0275 002290 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 20 TABLE INCLUDES: SEX=ALL}GROUP=ALL;WEEKS=ALL DEATH=2 ;SUBSET=ALL SPLEEN SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 524.2 44.5 ORGAN WEIGHT (g) 5 0.7046 0.1067 ORGAN-TOBODY WT (%) 5 0.1341 0.0120 ORGAN-TOBRAIN WT RATIO 5 0.3120 0.0619 SEX DOSE GROUP F4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) 5 246.7 17.5 ORGAN WEIGHT (g) 5 0.4750 0.0247 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.1930 0.0099 5 0.2303 0.0107 M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 5 0.7754 0.0826 5 0.1650 0.0135 5 0.3543 0.0103 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 249.1 26.1 5 0.4326* 0.0310 5 0.1749 0.0182 5 0.2141 0.0255 002291 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE 21 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2!SUBSET=ALL LF TESTIS SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g> 5 495.5 55.9 ORGAN WEIGHT <g> 5 1.7498 0.2466 ORGAN-TOBODY WT (%) 5 0.3560 0.0582 ORGAN-TOBRAIN WT RATIO 5 0.7964 0.1237 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT <g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 284.0 39.2 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 1.-7146 0.1818 5 0.3581 0.0344 5 0.7711 0.0617 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 M3 NUMBER IN GROUP MEAN STANDARD DEV 5 434.1 31.4 5 1.6809 0.0700 5 0.3887 0.0308 5 0.7394 0.0461 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL LF TESTIS SEX DOSE GROUP M4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (9) 5 524.2 44.5 ORGAN WEIGHT (g) 5 1.6548 0.1429 ORGAN-TOBODY WT (%) 5 0.3177 0.0390 ORGAN-TOBRAIN WT RATIO 5 0.7269 0.0220 SEX DOSE GROUP F4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT <g) 5 246.7 17.5 M5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 470.3 40.1 5 1.6454 0.1290 5 0.3504 0.0163 5 0.7561 0.0726 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 249.1 26.1 Covance 6329-183 3M T-6295 PAGE: 22 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 002292 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES : SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2;SUBSET=ALL RT TESTIS SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 495.5 55.9 ORGAN WEIGHT (g) 5 1.7446 0.2362 ORGAN-TOBODY WT <%) 5 0.3544 0.0524 ORGAN-TOBRAIN WT RATIO 5 0.7945 0.1246 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 284.0 39.2 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 1.6989 0.1610 5 0.3548 0.0310 5 0.7642 0.0531 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 M3 NUMBER IN GROUP MEAN STANDARD DEV 5 434.1 31.4 5 1.6716 0.0876 5 0.3863 0.0289 5 0.7356 0.0557 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 Covance 6329-183 3M T-6295 PAGE: 23 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 002293 002294 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 24 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2 ;SUBSET=ALL RT TESTIS SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 524.2 44.5 ORGAN WEIGHT (g) 5 1.6615 0.1437 ORGAN-TOBODY WT (%) 5 0.3190 0.0402 ORGAN-TOBRAIN WT RATIO 5 0.7299 0.0263 SEX DOSE GROUP F4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 246.7 17.5 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 5 1.6738 0.0932 5 0.3567 0.0134 5 0.7686 0.0513 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 249.1 26.1 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL jWEEKS=ALL DEATH=2;SUBSET=ALL LF THYROID/PARA SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 495.5 55.9 ORGAN WEIGHT (g) 5 0.0162 0.0098 ORGAN-TOBODY WT (%) 5 0.0032 0.0015 ORGAN-TOBRAIN WT RATIO 5 0.0074 0.0046 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 284.0 39.2 5 0.0069 0.0015 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 0.0121 0.0025 5 0.0025 0.0004 5 0.0054 0.0009 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 0.0098 0.0025 M3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 434.1 31.4 5 0.0140 0.0091 5 0.0033 0.0025 5 0.0060 0.0036 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 5 0.0080 0.0028 Covance 6329-183 3M T-6295 PAGE: 25 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.0024 0.0004 5 0.0033 0.0006 5 0.0033 0.0006 5 0.0047 0.0011 5 0.0030 0.0011 5 0.0040 0.0014 002295 002296 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329 -183 3M T- 6295 PAGE: 26 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=2;SUBSET=ALL LF THYROID/PARA SEX DOSE GROUP M4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) 5 524.2 44.5 ORGAN WEIGHT (g) 5 0.0143 0.0045 ORGAN-TOBODY WT (%) 5 0.0028 0.0011 ORGAN-TOBRAIN WT RATIO 5 0.0063 0.0020 SEX DOSE GROUP F4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT <%) ORGAN-TOBRAIN WT RATIO 5 246.7 17.5 5 0.0091 0.0008 5 0.0037* 0.0005 5 0.0044 0.0004 M5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 470.3 40.1 5 0.0114 0.0016 5 0.0025 0.0005 5 0.0053 0.0013 F5 NUMBER IN GROUP MEAN STANDARD DEV 5 249.1 26.1 5 0.0077 0.0012 5 0.0031* 0.0003 5 0.0038 0.0005 002297 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 27 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL RT THYROID/PARA SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 495.5 55.9 ORGAN WEIGHT (g) 5 0.0171 0.0080 ORGAN-TOBODY WT (%) 5 0.0034 0.0012 ORGAN-TOBRAIN WT RATIO 5 0.0078 0.0038 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 284.0 39.2 5 0.0097 0.0033 5 0.0035 0.0015 5 0.0047 0.0015 M2 NUMBER IN GROUP MEAN STANDARD DEV 5 481.0 51.3 5 0.0132 0.0038 5 0.0027 0.0006 5 0.0059 0.0016 F2 NUMBER IN GROUP MEAN STANDARD DEV 5 298.9 40.8 5 0.0110 0.0024 5 0.0037 0.0008 5 0.0052 0.0008 M3 NUMBER IN GROUP MEAN STANDARD DEV 5 434.1 31.4 5 0.0126 0.0017 5 0.0029 0.0005 5 0.0055 0.0007 F3 NUMBER IN GROUP MEAN STANDARD DEV 5 265.7 16.3 5 0.0116 0.0062 5 0.0044 0.0023 5 0.0057 0.0029 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL RT THYROID/PARA SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (3) 5 524.2 44.5 ORGAN WEIGHT (3) 5 0.0159 0.0058 ORGAN-TOBODY WT (%) 5 0.0031 0.0013 ORGAN-TOBRAIN WT RATIO 5 0.0069 0.0023 SEX DOSE GROUP F4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (3) ORGAN WEIGHT (3) 5 246.7 17.5 5 0.0097 0.0013 M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 5 0.0104 0.0014 5 0.0022 0.0004 5 0.0048 0.0008 F5 NUMBER IN GROUP MEAN STANDARD DEV 5 249.1 26.1 5 0.0095 0.0011 Covance 6329-183 3M T-6295 PAGE: 28 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.0039 0.0005 5 0.0047 0.0005 5 0.0038 0.0003 5 0.0047 0.0004 002298 002299 Table 23 Summary of Organ Height Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 29 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=21SUBSET=ALL UTERUS SEX DOSE GROUP M1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) 5 495.5 55.9 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) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 284.0 39.2 5 0.8644 0.3226 5 0.3157 0.1459 5 0.4244 0.1667 M2 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 481.0 51.3 F2 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 298.9 40.8 5 0.5986 0.1521 5 0.2010 0.0486 5 0.2906 0.0974 M3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 434.1 31.4 F3 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 265.7 16.3 5 0.8368 0.3843 5 0.3125 0.1335 5 0.4173 0.2021 002300 Table 23 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 30 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=2;SUBSET=ALL UTERUS SEX DOSE GROUP M4 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 5 524.2 44.5 ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F4 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 5 246.7 17.5 5 0.9249 0.3717 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 5 0.3815 0.1685 5 0.4478 0.1731 M5 NUMBER IN GROUP MEAN STANDARD DEV 5 470.3 40.1 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 249.1 26.1 5 0.7984 0.4389 5 0.3306 0.1980 5 0.3974 0.2223 002301 TABLE 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 1 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=3;SUBSET=ALL LF ADRENAL SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 9 713.4 105.5 ORGAN WEIGHT (g) 9 0.0313 0.0076 ORGAN-TOBODY WT (%) 9 0.0044 0.0010 ORGAN-TOBRAIN WT RATIO 9 0.0135 0.0036 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%> ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 10 0.0501 0.0290 10 0.0129 0.0091 10 0.0235 0.0135 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 9 0.0263 0.0046 9 0.0040 0.0008 9 0.0112 0.0018 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 0.0311* 0.0053 10 0.0095 0.0022 10 0.0141* 0.0024 002302 Table 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3H T-6295 PAGE: 2 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL RT ADRENAL SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 9 713.4 105.5 ORGAN WEIGHT (g) 9 0.0275 0.0060 ORGAN-TOBODY WT (%) 9 0.0039 0.0010 ORGAN-TOBRAIN WT RATIO 9 0.0119 0.0028 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT fg) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 10 0.0368 0.0072 10 0.0093 0.0027 10 0.0172 0.0032 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 9 0.0262 0.0031 9 0.0040 0.0007 9 0.0111 0.0011 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 0.0318 0.0037 10 0.0097 0.0016 10 0.0144* 0.0019 Table 24 Summary of organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=3;SUBSET=ALL BRAIN SEX DOSE GROUP M1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT <g> 9 713.4 105.5 ORGAN WEIGHT (g) 9 2.3308 0.1344 ORGAN-TOBODY WT (%) 9 0.3320 0.0442 ORGAN-TOBRAIN WT RATIO 9 1.0000 0.0000 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 10 414.5 101.9 10 2.1293 0.0884 M5 NUMBER IN GROUP: MEAN: STANDARD DEV: 9 668.6 142.5 9 2.3485 0.0730 9 0.3644 0.0722 9 1.0000 0.0000 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 2.2148 0.1036 Covance 6329-183 3M T-6295 PAGE: 3 ORGAN-TOBODY WT (%) ORGAN-TO- BRAIN WT RATIO 10 0.5376 0.1129 10 1.0000 0.0000 10 0.6752* 0.0817 10 1.0000 0.0000 002303 002304 Table 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3H T-6295 PAGE: 4 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=3;SUBSET=ALL LF KIDNEY SEX DOSE GROUP M1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) 9 713.4 105.5 ORGAN WEIGHT (g) 9 2.3449 0.1955 ORGAN-TOBODY WT (%) 9 0.3327 0.0397 ORGAN-TOBRAIN WT RATIO 9 1.0078 0.0857 SEX DOSE GROUP F1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 10 414.5 101.9 10 1.3621 0.2284 ORGAN-TOBODY WT <%> ORGAN-TOBRAIN WT RATIO 10 0.3357 0.0458 10 0.6391 0.1000 M5 NUMBER IN GROUP: MEAN: STANDARD DEV: 9 668.6 142.5 9 2.4193 0.2614 9 0.3712 0.0597 9 1.0322 0.1260 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 331.9* 39.7 10 1.3638 0.1321 10 0.4149* 0.0532 10 0.6171 0.0668 002305 Table 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 5 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL RT KIDNEY SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT <g) 9 713.4 105.5 ORGAN WEIGHT fg) 9 2.3577 0.2008 ORGAN-TOBODY WT (%) 9 0.3340 0.0348 ORGAN-TOBRAIN WT RATIO 9 1.0129 0.0842 SEX DOSE GROUP F1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT <g> ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 10 1.4200 0.2361 10 0.3498 0.0447 10 0.6665 0.1046 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 9 2.4080 0.2312 9 0.3690 0.0529 9 1.0271 0.1109 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 331.9* 39.7 10 1.3769 0.1375 10 0.4193* 0.0574 10 0.6224 0.0631 002306 Table 24 Summary Qf Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 6 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL LIVER SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 9 713.4 105.5 9 20.0275 3.0980 ORGAN-TOBODY WT (%) ORGAN-TO BRAIN WT RATIO 9 2.8113 0.2044 9 8.6130 1.4054 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%> ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 10 11.5769 3.0344 10 2.8031 0.3109 10 5.4312 1.3763 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 9 26.6325* 5.5590 9 4.0039* 0.5449 9 11.3659 2.4751 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 13.8907 1.8568 10 4.2047* 0.5156 10 6.2883 0.8921 Table 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=3;SUBSET=ALL LUNG SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 9 713.4 105.5 ORGAN WEIGHT (g) 9 2.1599 0.2545 ORGAN-TOBODY WT (%) 9 0.3061 0.0413 ORGAN-TOBRAIN WT RATIO 9 0.9293 0.1174 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 10 414.5 101.9 10 1.6819 0.2502 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 9 2.0477 0.1879 9 0.3151 0.0524 9 0.8719 0.0758 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 1.5740 0.0922 Covance 6329-183 3M T-6295 PAGE: 7 ORGAN-TOBODY WT (%) ORGAN-TO- BRAIN WT RATIO 10 0.4215 0.0901 10 0.7913 0.1262 10 0.4797 0.0598 10 0.7114 0.0433 002307 002308 Table 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 8 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL LF OVARY SEX DOSE GROUP M1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) 9 713.4 105.5 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) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 10 0.0562 0.0192 10 0.0138 0.0045 10 0.0265 0.0092 M5 NUMBER IN GROUP: MEAN: STANDARD DEV: 9 668.6 142.5 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 0.0557 0.0123 10 0.0170 0.0040 10 0.0253 0.0061 002309 Table 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES : SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL RT OVARY Covance 6329-183 3M T-6295 PAGE: 9 SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 9 713.4 105.5 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) 10 414.5 101.9 10 0.1357 0.2404 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 10 0.0321 0.0549 10 0.0630 0.1107 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 F5 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 331.9* 39.7 10 0.0561 0.0129 10 0.0171 0.0044 10 0.0254 0.0062 002310 Table 24 Summary pf Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 10 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=3 ;SUBSET=ALL SPLEEN SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (9) 9 713.4 105.5 ORGAN WEIGHT (9) 9 0.9792 0.0975 ORGAN-TOBODY WT (%) 9 0.1382 0.0100 ORGAN-TOBRAIN WT RATIO 9 0.4208 0.0427 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (9) ORGAN WEIGHT (9) ORGAN-TOBODY WT <%) ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 10 0.5577 0.1021 10 0.1368 0.0178 10 0.2611 0.0419 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 9 0.8287* 0.1514 9 0.1252* 0.0133 9 0.3529* 0.0635 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 0.5491 0.1344 10 0.1650* 0.0306 10 0.2468 0.0537 002311 Table 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 11 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL LF TESTIS SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 9 713.4 105.5 ORGAN WEIGHT (g) 9 1.8551 0.3741 ORGAN-TOBODY WT (%) 9 0.2641 0.0658 ORGAN-TOBRAIN WT RATIO 9 0.7968 0.1645 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT <%) ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 9 1.6414 0.3094 9 0.2531 0.0628 9 0.6995 0.1325 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 002312 Table 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3H T-6295 PAGE: 12 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=3;SUBSET=ALL RT TESTIS SEX DOSE GROUP M1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT <g> 9 713.4 105.5 ORGAN WEIGHT (g) 9 1.8759 0.1801 ORGAN-TOBODY WT (%) 9 0.2683 0.0491 ORGAN-TOBRAIN WT RATIO 9 0.8100 0.1189 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 M5 NUMBER IN GROUP: MEAN: STANDARD DEV: 9 668.6 142.5 9 1.6551 0.2786 9 0.2560 0.0631 9 0.7054 0.1203 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 002313 Table 24 Summary of Organ Height Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 13 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL LF THYROID/PARA SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) 9 713.4 105.5 ORGAN WEIGHT (g) 9 0.0246 0.0060 ORGAN-TOBODY WT (%) 9 0.0035 0.0008 ORGAN-TOBRAIN WT RATIO 9 0.0106 0.0027 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT <g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 10 0.0136 0.0062 10 0.0034 0.0018 10 0.0065 0.0034 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 9 0.0195* 0.0041 9 0.0029 0.0004 9 0.0083* 0.0018 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 0.0115 0.0036 10 0.0034 0.0010 10 0.0052 0.0016 Table 24 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL RT THYROID/PARA SEX DOSE GROUP M1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT <g> 9 713.4 105.5 ORGAN WEIGHT (g) 9 0.0249 0.0048 ORGAN-TOBODY WT (%) 9 0.0035 0.0007 ORGAN-TOBRAIN WT RATIO 9 0.0107 0.0018 SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) 10 414.5 101.9 10 0.0148 0.0039 M5 NUMBER IN GROUP MEAN STANDARD DEV 9 668.6 142.5 9 0.0240 0.0093 9 0.0036 0.0013 9 0.0102 0.0040 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 0.0124 0.0046 Covance 6329-183 3M T-6295 PAGE: 14 ORGAN-TOBODY WT (%) ORGAN-TO- BRAIN WT RATIO 10 0.0037 0.0011 10 0.0070 0.0019 10 0.0038 0.0014 10 0.0056 0.0021 002314 002315 Table 24 Summary of Organ Height Data Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 15 TABLE INCLUDES: SEX=ALL ;GROUP-ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL UTERUS SEX DOSE GROUP M1 NUMBER IN GROUP: MEAN: STANDARD DEV: TERMINAL BODY WT (g) ORGAN WEIGHT (g) 9 713.4 105.5 ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO SEX DOSE GROUP F1 NUMBER IN GROUP MEAN STANDARD DEV TERMINAL BODY WT (g) ORGAN WEIGHT (g) ORGAN-TOBODY WT (%) ORGAN-TOBRAIN WT RATIO 10 414.5 101.9 10 1.0175 0.3207 10 0.2557 0.0951 10 0.4771 0.1461 LO 53 t NUMBER IN GROUP: MEAN: STANDARD DEV: 9 668.6 142.5 F5 NUMBER IN GROUP MEAN STANDARD DEV 10 331.9* 39.7 10 1.0062 0.3090 10 0.3111 0.1154 10 0.4587 0.1545 002316 TABLE 25 Incidence of Macroscopic Observations Week 4 Sacrifice Covance 6329-183 3M T-6295 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* PAGE: 1 TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4,5;WEEKS=ALL DEATH=1;SUBSET=ALL -- N U M BE R -0F -A N IMA L S -A F FE SEX: GROUP: -1- -2- -3- -4- -5- -1- -2- -3- -4- -5- ORGAN AND KEYWORD (S) OR PHRASE NUMBER: 5 5 5 5 5 5 5 5 5 5 ** TOP OF LIST ** GENERAL COMMENT (GC) ................ ............... NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NO MACROSCOPIC LESIONS ** END OF LIST ** 5555555555 002317 TABLE 26 Incidence of Macroscopic Observations Week 14 Sacrifice Covance3M63T29-6-128935 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS `DRAFT* PAGE: 1 TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4,5;WEEKS=ALL DEATH=2 ;SUBSET=ALL -- N UMBER -0F -AN IMA LS-AFFEC SEX: -MALE-- -FEMALE--- GROUP: -1- -5- ORGAN AND KEYWORD (S) OR PHRASE NUMBER: 5 5 5 5 5 5 5 5 5 5 " TOP OF LIST " GENERAL COMMENT (GC) .............. ................. NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NO MACROSCOPIC LESIONS BONE MARROW SMEAR TAKEN MALOCCLUSION 314332 5423 4 555555555 0 0 00 1 0 0 0 00 KIDNEY <KD) ....................... ................. NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NOT REMARKABLE: 5 4 4 4 4 4 5 5 4 5 CYST(S) LARGE PELVIS (ES) GRANULAR MATERIAL 0 0 00 0 1 0 000 0111100010 0 0 00 0 0 0 0 10 UTERUS (UT) ....................... ................. NUMBER EXAMINED: 0 0 0 0 0 5 5 5 5 5 NOT REMARKABLE: 0 0 0 0 0 3 5 4 3 3 LUMEN FILLED WITH FLUID 000002 0122 THYMUS (TH) ....................... ................. NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NOT REMARKABLE: 4 5 5 5 4 5 5 5 5 5 RED FOCUS (I )/AREA (S ) 100010 0000 002318 TABLE 26 Incidence of Macroscopie Observations Week 14 Sacrifice Covance 6329-183 3M T-6295 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4, 5;WEEKS=ALL DEATH=2;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-------- -------- FEMALE------GROUP: -1- -2- -3- -4- -5- -1- -2- -3- -4- -5NUMBER: 5 5 5 5 5 5 5 5 5 5 HARDERIAN GLAND (HG) ... MISSING/NOT IDENTIFIED STOMACH, GL {ST) ...... DARK FOCUS(I)/AREA(S) LN, MANDIBULAR (MN) --- DIFFUSELY RED ** END OF LIST ** NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NOT REMARKABLE: 5 4 5 55 5 5 5 55 0 10 0 0 0 0 0 00 NUMBER EXAMINED: 5 5 5 55 5 5 5 55 NOT REMARKABLE: 5 4 5 5 5 4 5 5 5 4 0 10 0 0 1 0 0 01 NUMBER EXAMINED: 5 NOT REMARKABLE: 4 55 5 5 5 5 55 5 25 4 5 5 5 55 5 13 0 10 0000 0 002319 TABLE 27 Incidence of Macroscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 1 TABLE INCLUDES: SEX=ALL ;GROUP=ALL;WEEKS=ALL DEATH=3;SUBSET=ALL N U M B E R - O F - ANI M A LS- A F F E C T E D -- SEX: -- MALE--- -FEMALE-- - GROUP: -1- -2- -3- -4- -5- -6- -1- -2- -3- -4- -5- -6- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: ------ --------------------------------- ---------- ____ ___________._____ ** TOP OF LIST ** GENERAL COMMENT (GC) ......................... 90 _ ___ 90 0 --_ ___0 9 ___ 0 ___ 10 __ 0 ___ 0 ___ 0 ___ 0 0 9 0 10 0 0 0 10 0 _ ___ 10 0 NO MACROSCOPIC LESIONS BONE MARROW SMEAR TAKEN MALOCCLUSION ANIMAL OBESE 50003 01 00020 9 0 0 0 9 0 10 0 0 0 10 0 1000102 00000 2 00010000000 EYE (EY) ..................................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 BRAIN (BR) .................................... COMPRESSED (HYPOTHALAMUS) LIVER (LI) .................................... DIFFUSELY DARK KIDNEY (KD) ................................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 9 0 0 0 10 0 0000001 00000 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 9 0 0 000 00 0 00010 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 002520 Table 27 Incidence of Macroscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance3M63T29-6-128935 PAGE: 2 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL ORGAN AND KEYWORD(S) OR PHRASE ------------------------------- -- SPLEEN (SP) .......................... CYST(S) PANCREAS (PA) ... ..................... MASS(ES) ADRENAL, CORTEX (AC) ..... ............ LARGE ADRENAL, MEDULLA (MA) ................ N UMBE R -0F -AN IMA LS -AFFECTED -- SEX: -- MALE--- --FEMALE-- - GROUP: -1- -2- -3- -4- -5- -6- -1- -2- -3- -4- -5- -6- NUMBER: 9 0 0 0 9 0 10 0 0 0 10 0 -=- ~=~ -=" "=- -=" -=- -=- -=~ 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 9 0 000000000010 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 9 0 0 0 10 0 0 0 0 0 0 0 1 0 0 0 0 0 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 9 0 0 0 10 0 0 00 0 00100000 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 LN, MESENTERIC (MS) .................. 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 UTERUS (UT) .......................... LUMEN FILLED WITH FLUID ** CONTINUED ON NEXT PAGE ** 0 0 0 0 0 0 10 0 0 0 10 0 NOT REMARKABLE: 0 0 0 0 0 0 9 0 0 0 9 0 0 0 0 0 0 0000010 Table 27 Incidence of Macroscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS C o v a n ce 3M6 3T2 9-6- 128935 PAGE: 3 TABLE INCLUDES: SEX=ALL;GROUP=ALL ;WEEKS=ALL DEATH=3;SUBSET=ALL N U M B E R - 0 F - ANI M A L S - A F F E C T E D -- SEX: -- MALE--- -FEMALE-- - GROUP: -1- -2- -3- -4- -5- -6- -1- -2- -3- -4- -5- -6- ORGAN AND KEYWORD (S) OR PHRASE ------------ ---------------- -----_____- ----- -------- ----- ----N-U-MB-E_R--:_ 9 ------ _=0-- -=-0 0 --=-- _=_9 0 -2- _120-- 0 --2-- 0 --=-- -2-0 10 "=-- 0 -2- ** FROM PREVIOUS PAGE ** UTERUS (UT) ........................ 0 0 0 0 0 0 10 0 0 0 10 0 NOT REMARKABLE: 0 0 0 0 0 0 9 0 0 0 9 0 THICKENED WALL 000 000100000 TESTIS (TE) ........................ 900 090000000 NOT REMARKABLE: 8 0 0 0 8 0 0 0 0 0 0 0 SMALL 1 0 0 0 1 0 0 0 0 0 0 0 BONE, FEMUR (FE) ................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 MARROW, FEMUR (FM) ................. 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 MARROW, STERNUM (SE) ............... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 BONE, STERNUM (SB) ................. ................ NUMBER EXAMINED: 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 002321 * 002322 Table 27 Incidence of Macroscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance3M63T29-6-128935 PAGE: 4 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3;SUBSET=ALL N U M B E R - O F - A N I M A L S - A F F E C T E D -- SEX: -- MALE--- -- FEMALE-- GROUP: -1- -2- -3- -4- -5- -6- -1- -2- -3- -4- -5- -6- ORGAN AND KEYWORD (S) OR PHRASE NUMBER: 9 0 0 --- ---------------------------------------- -- ----------------- ---- -=- -=- -=- SPINAL CORD (SC) ............................ 900 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 -=- -=- -=- -=- -=- '= -=- -=~ 0 9 0 10 0 0 0 10 0 0 9 0 10 0 0 0 10 0 THYMUS (TH) ................................. LARGE GELATINOUS LUNG (LU) .................................. . LIGHT FOCUS(I)/AREA(S ) DARK FOCUS(I )/AREA(S ) HEART (HT) .................................. 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 8 0 10 0 0 0 10 0 000010000000 000 010000000 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 8 0 0 0 9 0 10 0 0 0 8 0 00 0000000020 1 0 0 0 0000 0000 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 MUSCLE, SKELETAL (SM) ....................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 NERVE, SCIATIC (SN) ......................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 002323 Table 27 Incidence of Macroscopic Observations Week 53 sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS C o v a n ce 3M6 3T2 9-6- 128935 PAGE: 5 TABLE INCLUDES: SEX=ALL;GR0UP=ALL;WEEKS=ALL DEATH=3;SUBSET=ALL ORGAN AND KEYWORD(S) OR PHRASE -- ---- -----~"----~---------------------------- -- TRACHEA (TR) .............................. N UM BE R -0F -A N IMA L S -A F FE CTED -- SEX: -- MALE--- -FEMALE- -- GROUP: -1- -5- -4- NUMBER: 9 0 0 -=- -=- -=- 900 NOT REMARKABLE: 9 0 0 09 =- -=- 09 09 0 10 -=- 0 10 0 10 0 0 0 10 0 -=" -=- -=" -=" 0 0 0 10 0 0 0 0 10 0 ESOPHAGUS (ES) ............................ 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 THYROID (TY) .............................. 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 PARATHYROID (PT) .......................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 PITUITARY (PI) ............................ LARGE DARK FOCUS (I)/AREA (S) RED FOCUS (I)/AREA(S) RAISED AREA(S) CYST(S) HARDERIAN GLAND (HG) ...................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 8 0 6 0 0 0 4 0 0 0 0 0 0 0 20 0030 0 00 00 020 0000 0 0 0 0 0 0 0 0 0020 000000 000010 000010000000 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 002324 Table 27 Incidence of Macroscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 6 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL ORGAN AND KEYWORD(S) OR PHRASE ---------- -------- ------------- --------- -- SALIV GL, MANDIB (SG) .................. N U M B E R - 0 F - A N I M A L S - A F F E C T E D -- SEX: --- MALE --FEMALE--- GROUP: -1- -2- NUMBER: 9 0 0 0 9 0 10 -=- -=- -=- -=- -=- -=- -=- 9 0 0 0 9 0 10 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 --=- -=- - -- -- ------ 0 0 0 10 0 0 0 0 10 0 STOMACH, GL (ST) ........................ RED FOCUS (I)/AREA(S) THICKENED WALL STOMACH, NONGL (SU) .................... THICKENED WALL DUODENUM (DU) .......................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 7 0 10 0 0 0 10 0 000 01 0000000 0 0 0 0 1 0 0 0 0 0 0 0 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 8 0 10 0 0 0 10 0 000010000000 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 JEJUNUM (JE) ........................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 ILEUM (IL) ............................. 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 002325 Table 27 Incidence of Macroscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 7 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL ORGAN AND KEYWORD(S) OR PHRASE -------- ----------- ----------------------- -- CECUM (CE) ................................ N UMBER -0F -AN IMA LS-AFFECTED -- SEX: --- MALE--- --FEMALE-- GROUP: -1- -2- -3- -4- -5- -6- -1- -2- -3- -4- -5- -6- NUMBER: 9 9 NOT REMARKABLE: 9 00 -=- 00 00 0 9 0 10 0 0 0 10 0 =~ -=- -=~ -=- -=- -=" -=- -=" -=- 0 9 0 10 0 0 0 10 0 0 9 0 10 0 0 0 10 0 COLON (CO) ................................ 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 RECTUM (RE) ............................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 o' 0 9 0 10 0 0 0 10 0 SKIN (SK) ................................. CRUSTED AREAIS) LIGHT AREA (S)/FOCUS (I) MAMMARY, FEMALE (MF) ....................... MASS(ES) THICKENED CYST(S) URINARY BLADDER (UB) ...................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 8 0 0 0 10 0 00000 0200000 000000100000 0 0 0 0 0 0 10 0 0 0 10 0 NOT REMARKABLE: 0 0 0 0 0 0 6 0 0 0 10 0 000000100000 00 00 0 01 00000 000000200000 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 Table 27 Incidence of M acroscopie Observations Week 53 S a c r if ic e 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance3M63T29-6-128935 PAGE: 8 TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=3 ;SUBSET=ALL N U M B E R - 0 F - A N I M A L S - A F F E C T E D -- SEX: -- MALE--- -- FEMALE-- GROUP: -1- -2- -3- -4- -5- -6- -1- -2- -3- -4- -5- -6- ORGAN AND KEYWORD (S) OR PHRASE NUMBER: 9 0 ------- ---- --------------- -- ---- -- ---------------------------- -=- -=- 009 -=- -=- 0 10 0 0 0 10 0 -=- -=- -=- -=- -s- -=- CERVIX (CV) ...................... 0 0 0 0 0 0 10 0 0 0 10 0 NOT REMARKABLE: 0 0 0 0 0 0 9 0 0 0 10 0 MASS(ES) 000000100000 OVARY (OV) ....................... 0 0 0 0 0 0 10 0 0 0 10 0 NOT REMARKABLE: 0 0 0 0 0 0 9 0 0 0 10 0 CYST(S) 000000100000 VAGINA (VA) ...................... 0 0 0 0 0 0 10 0 0 0 10 0 NOT REMARKABLE: 0 0 0 0 0 0 10 0 0 0 10 0 PROSTATE (PR) .................... 9 0 0 0 9 00 0 000 0 NOT REMARKABLE: 9 0 0 0 9 0 0 0 0 0 0 0 SEMINAL VESICLES (SV) ............ 9 0 0 0 9 0 0 0 000 0 NOT REMARKABLE: 9 0 0 0 9 0 0 0 0 0 0 0 EPIDIDYMIDES (EP) ................ 900090000000 NOT REMARKABLE: 9 0 0 0 9 0 0 0 0 0 0 0 002327 Table 27 Incidence of Macroscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 9 1o 11 ! TABLE INCLUDES: SEX=ALL ;GR0UP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL ORGAN AND KEYWORD(S) OR PHRASE --------------------------------------- -- -- CAVITY, THORACIC (TA) ..................... NUMBE F -A N IMA L S -A FFECTE D -- SEX: --- MALE--- -- FEMALE-- GROUP: -1- -2- -3- -4- -5- -6- -1- -2- -3- -4- -5- -6- NUMBER: 9 -=- 9 NOT REMARKABLE: 9 00 -=- 00 00 0 9 0 10 0 0 0 -=- -=" -=- -=- -=" -- 0 9 0 10 0 0 0 0 9 0 10 0 0 0 10 0 -=- 10 0 10 0 TAIL (TI) ................................. 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 LN, MANDIBULAR (MN) ....................... DIFFUSELY RED LN, MEDIASTINAL (ML) ...................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 8 0 0 0 9 0 0 0 0 0 00 2 0 001 0 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 LN, AXILLARY (AX) ......................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 LN, INGUINAL (IN) ......................... 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 LN, OTHER (LN) ............................ 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 Table 27 Incidence of M acroscopic Observations Week 53 S a c r if ic e 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 10 TABLE INCLUDES: SEX=ALL ;GROUP=ALL ;WEEKS=ALL DEATH=3 ;SUBSET=ALL -- N U M B E R - 0 F - A N I M A L S - A F F E C TED -- SEX: -------- MALE--- -- FEMALE-- GROUP: -1- -2- -3- -4- -5- -6- -1- -2- -3- -4- -5- -6- ORGAN AND KEYWORD (S) OR PHRASE NUMBER: 9 0 0 0 9 0 10 0 0 0 10 0 ------------------------ ----- ---- ------- --------- ------- ------- --- --=- - --=" "=" -=- -=" --- -=- LN, RENAL (RL) .................. 9 0 0 0 9 0 10 0 0 0 10 0 NOT REMARKABLE: 9 0 0 0 9 0 10 0 0 0 10 0 MAMMARY, MALE (MM) ................ 900090000000 NOT REMARKABLE: 9 0 0 0 9 0 0 0 0 0 0 0 COAGULATING GL (CG) ................ ................ NUMBER EXAMINED: 900090000000 NOT REMARKABLE: 9 0 0 0 9 0 0 0 0 0 0 0 ** END OF LIST ** 002328 TABLE 28 Incidence of M icroscopic Observations Week 14 S a c r if ic e 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 1 TABLE INCLUDES: SEX=ALL,-GROUP=l,2,3,4,5;WEEKS=ALL DEATH=2 ;FIND=ALL; SUBSET=ALL ORGAN AND FINDING DESCRIPTION --- -------------------------------------- --- ** TOP OF LIST ** EYE (EY) ......................... N UMBER -0F -AN IMA LS -A FFEl SEX: -MALE----- -FEMALE--- 1 1 1 lb. GROUP: -1- -2- -5- -1- -2- -3- -4- -5- NUMBER: 5 5 5 5 5 5 5 5 5 5 ---_____------_--------_----_ ----_ _"- _= =_ _---- _--_ _=_ _=_ _=- ------ 5555555555 NOT REMARKABLE: 5 5 5 5 5 5 5 5 5 5 BRAIN (BR) .................... 5 5 5 55 55 5 55 NOT REMARKABLE: 5 5 5 5 5 5 5 5 5 5 LIVER (LI) .......................................... NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NOT REMARKABLE: 0 0 0 0 0 2 0 0 0 0 -- INFILTRATE, LYMPHOHISTIOCYTIC -- HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR -- NECROSIS, INDIVIDUAL HEPATOCYTE -- VACUOLATION, HEPATOCELLULAR, MIDZONAL / CENTRILOBULAR -- VACUOLATION, HEPATOCELLULAR, PERIPORTAL --FOCUS, ALTERED HEPATOCELLULAR, CLEAR CELL -- NECROSIS, COAGULATIVE 555 5535555 00a5500014 2 2 0 12 122 13 00034 01002 23 2 00 1 03 21 0000000110 0 0 0 0 0 001 00 KIDNEY (KD) ......................................... NUMBER EXAMINED: 5 5 5 5 5 s 5 5 5 5 NOT REMARKABLE: 0 1 1 2 1 2 5 2 3 5 --INFILTRATE, LYMPHOHISTIOCYTIC --DILATATION, PELVIC -- MINERALIZATION, PELVIC -- REGENERATION, TUBULAR EPITHELIUM -- MINERALIZATION, TUBULAR 422323 0310 02 11 2 0 01 10 00 0 01 00 0 10 1013110000 00 0 00 001 00 002330 Table 28 Incidence of Microscopic Observations Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 2 TABLE INCLUDES: SEX=ALL ;GROUP=l,2,3,4,5 ;WEEKS=ALL DEATH=2;FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION SPLEEN (SP) ............... --PIGMENT, INCREASED PANCREAS IPA) --ATROPHY, ACINAR --INFILTRATE, LYMPHOHISTIOCYTIC -- INFILTRATE, MACROPHAGE, PIGMENTED -- HYPERPLASIA, ISLET CELLS ADRENAL, CORTEX IAC) ................ -- VACUOLATION, FOCAL --UNILATERALLY EXAMINED ADRENAL, MEDULLA IMA) ___ --UNILATERALLY EXAMINED LN, MESENTERIC (MS) ..... --HEMORRHAGE ---- N U M B E R - 0 F - A N I M A L S - A F F E < SEX: GROUP : -1- -2- -3- --4- -5- -1- -2- -3- -4- -5- sNUMBER: 555555555 '=- -=- -=- "=- -=- -=- "=' -=- -=- NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NOT REMARKABLE: 3 3 4 5 4 0 0 1 0 0 22 101554 55 NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NOT REMARKABLE: 4 2 5 3 4 4 5 5 3 5 00 02 1 0 00 10 02 02 1 1 0 0 10 1100000000 0001000000 NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NOT REMARKABLE: 5 3 5 5 5 4 5 5 4 5 0100000000 0100010010 NUMBER EXAMINED: 5 5 5 5 5 5 5 5 5 5 NOT REMARKABLE: 5 4 5 5 5 4 5 5 4 5 0 1 0 0 0 1 00 10 NUMBER EXAMINED: 5 5 5 4 5 5 5 5 5 5 NOT REMARKABLE: 5 5 5 4 4 5 5 5 5 5 0000100000 002331 Table 28 Incidence of Microscopic Observations Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 3 TABLE INCLUDES: SEX=ALL; GROUP=l,2,3,4, 5;WEEKS=ALL DEATH=2,-FIND=ALL;SUBSET=ALL ORGAN AND FINDING DESCRIPTION OVARY (OV) ....................... -- N U M B E R - O F - A N I M A L S - A F F E C T E SEX: -MALE- -FEMALE- GROUP: -1- -2- -3- -4- -5- -1- -2- -3- -4- -5- ------------------ NUMBER: -------- 5 -=- 5 -=" 5 -=- 5 -=- 5 -=- 5 -=- 5 -=" 5 --- S = 55 -=" NUMBER EXAMINED: 0 0 0 0 0 5 5 5 5 5 NOT REMARKABLE: 0 0 0 0 0 5 5 5 5 5 D-- TESTIS (TE) ...................... -- ATROPHY /DEGENERATION UTERUS (UT) ...................... NUMBER EXAMINED: 5 5 5 5 5 0 0 0 0 0 NOT REMARKABLE: 4 5 5 5 5 0 0 0 0 0 1000000000 NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 BONE, FEMUR (FE) ................. NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 MARROW, FEMUR (FM) ............... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 MARROW, STERNUM (SE) NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 BONE, STERNUM (SB) NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 002332 Table 28 Incidence of Microscopic Observations Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* Covance 6329 -183 3M T- 6295 PAGE: 4 TABLE INCLUDES: SEX=ALL ;GR0UP=1,2,3,4, 5;WEEKS=ALL DEATH=2:FIND=ALL;SUBSET=ALL -- NUMBER-0F -AN IMALS -AFFE< SEX: - -MALE-- -FEMALE--- GROUP: -1- --2- -3- -4- -5- -1- -2- -3- -4- -5- ORGAN AND FINDING DESCRIPTION NUMBER: 5 5 5 5 5 5 5 5 5 5 -- ---- ------------------ ------------ ------------------------ =- --=-- -=- --=- -=- -=- -=- -=- -=* -=- SPINAL CORD (SC) ................. `............ 00000 00000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 THYMUS (TH) .................................... 00 0 00 00 000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 LUNG (LU) ...................................... 0 0 0 00 00 000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 HEART (HT) ..................................... 0 0 0 00 00 000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 MUSCLE, SKELETAL (SM) .......................... NERVE, SCIATIC (SN) ............................ 0 0 0 00 0 0000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 00000 00000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 TRACHEA (TR) ................................... 00 00 0 0 0000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 002333 Table 28 Incidence of Microscopie Observations Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS DRAFT* C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 5 TABLE INCLUDES: SEX=ALL;GR0UP=1,2,3,4,5;WEEKS=ALL DEATH=2 ;FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION N UMBER -0F -AN IMA LS -A FFE( SEX: -MALE-- -FEMALE--- GROUP: -1- -2- -3- -4- -5- -1- -2- -3- -4- -5- NUMBER: 5 S 5 5 5 5 5 5 5 5 ESOPHAGUS (ES) ................... ......... 0 0 00 0 000 00 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 THYROID (TY) ............................... 0000000000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 PARATHYROID (PT) ........................... 0000000000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 PITUITARY (PI) ............................. HARDERIAN GLAND (HG) ....................... 0000 000000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 0000 000000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 SALIV GL, MANDIB (SG) ...................... 0000 000000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 STOMACH, GL (ST) ........................... 0000 000000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 002334 Table 28 Incidence of Microscopic Observations Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS `DRAFT* Covance 6329 -183 3M T- 6295 PAGE: 6 TABLE INCLUDES: SEX=ALL;GROUP=l,2,3,4,5;WEEKS=ALL DEATH=2 ;FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION -- N U M B E R -0F -A N IMA L S -A F FE i SEX: -MALE-- -FEMALE--- GROUP: -1- -2- -3- -4- -5- -1- -2- -3- -4- -5- NUMBER: 5 5 5 5 5 5 5 5 5 5 STOMACH, NONGL (SU) ....... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 DUODENUM (DU) JEJUNUM (JE) NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 ILEUM (IL) NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 Q 0 0 0 0 0 CECUM (CE) .. COLON (CO) NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 RECTUM (RE) NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 Q 0 0 0 0 0 002335 Table 28 Incidence of Microscopic Observations Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS `DRAFT* C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 7 TABLE INCLUDES: SEX=ALL ;GROUP= 1,2,3,4, 5;WEEKS=ALL DEATH=2 :FIND=ALL; SUBSET=ALL ORGAN AND FINDING DESCRIPTION SKIN (SK) ........................ ... N U M B E R - 0 F - A N I M A L S - A F F E i SEX: GROUP: -1- -2- -3- --4- -5- -1- -2- -3- -4- -5- --- -------N--U--M--B--E--R--:-- 5 -=- 5 --S-- 5 -=" 5 "=* 5 -=- 5 -=~ 5 -=" 5 -=-- 5 ------ 5 -=- NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 MAMMARY, FEMALE (MF) ............. NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 URINARY BLADDER (UB) ............. NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 CERVIX (CV) ...................... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 VAGINA (VA) ...................... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 PROSTATE (PR) .................... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 SEMINAL VESICLES <SV) NUMBER EXAMINED: 0 0 0 0 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 002336 Table 28 Incidence of Microscopie Observations Week 14 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS *DRAFT* Covance 6329-183 3M T-6295 PAGE: 8 TABLE INCLUDES: SEX=ALL:GR0UP=1,2,3,4,5;WEEKS=ALL DEATH=2 ;FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION -- N U MB ER -0 F -A N IMA L S -A FFE SEX: -MALE-- -FEMALE--- GROUP : -1- -2- -3- -4- -5- -1- -2- -3- -4- -5- NUMBER: 5 5 5 5 5 5 5 5 5 5 EPIDIDYMIDES (EP) ................ !............. ** END OF LIST ** 0000000000 NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 0 002337 TABLE 29 Incidence of Microscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS C o v a n c e 3M6 3T2 9-6- 128935 PAGE: 1 TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=3 ;FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION ** TOP OF LIST ** EYE (EY) ......................................... -- N U M B E R - I SEX: -- MALE-- -FEMALEGROUP: -1- -5- -1- -5NUMBER: 10 9 10 10 10 NOT REMARKABLE: 10 9 10 10 9 10 10 A N I M A L S A F F E C T E D -- BRAIN (BR) ....................................... NOT REMARKABLE: -- COMPRESSION, VENTRAL LIVER (LI) ....................................... NOT REMARKABLE: -- INFILTRATE, LYMPHOHISTIOCYTIC -- HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR -- NECROSIS, INDIVIDUAL HEPATOCYTE --VACUOLATION, HEPATOCELLULAR, MIDZONAL / CENTRILOBULAR --VACUOLATION, HEPATOCELLULAR, PERIPORTAL --FOCUS, ALTERED HEPATOCELLULAR, CLEAR / EOSINOPHILIC CELL --HYPERPLASIA, BILE DUCT --HYPERTROPHY, HEPATOCELLULAR, PERIPORTAL -- INFILTRATE, MACROPHAGE, PIGMENTED --VACUOLATION, HEPATOCELLULAR --HYPERTROPHY, HEPATOCELLULAR --FOCUS, ALTERED HEPATOCELLULAR, BASOPHILIC -- CYST, BILIARY --INFLAMMATION, SUBACUTE -- PIGMENT, HEPATOCELLULAR 10 10 0 10 0 9 0 0 1 3 7 1 1 2 3 0 0 0 0 0 9 10 10 9 9 10 010 9 10 10 020 569 809 233 500 221 000 02 3 000 103 331 100 100 001 020 006 002338 Table 29 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329 -183 3M T- 6295 PAGE: 2 TABLE INCLUDES: SEX=ALL;GROUP=1,5;WEEKS=ALL DEATH=3,-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- -5- -1- -5NUMBER: 10 9 10 10 KIDNEY (KD) ..................................... ___ NUMBER EXAMINED: 10 NOT REMARKABLE: 0 --INFILTRATE, LYMPHOHISTIOCYTIC --DILATATION, PELVIC --MINERALIZATION, PELVIC --REGENERATION, TUBULAR EPITHELIUM -- MINERALIZATION, TUBULAR -- NEPHROPATHY, CHRONIC PROGRESSIVE -- PIGMENT, TUBULAR --HYALINE DROPLETS, TUBULAR EPITHELIUM -- INFILTRATE, MACROPHAGE, PIGMENTED 0 0 1 1 0 9 0 0 0 SPLEEN (SP) ..................................... 10 NOT REMARKABLE: 0 -- PIGMENT, INCREASED -- HEMATOPOIESIS, EXTRAMEDULLARY, INCREASED --FIBROUS TAGS 10 6 0 PANCREAS (PA) ................................... 10 NOT REMARKABLE: 3 --ZYMOGEN GRANULES, DECREASED --INFILTRATE, LYMPHOHISTIOCYTIC --INFILTRATE, MACROPHAGE, PIGMENTED --HYPERPLASIA, ISLET CELLS * * CO--NATTINROUPEHDY,ONANCIENXATRPAGE ** 1 1 5 2 1 9 10 10 112 101 001 0 64 000 146 63 1 211 100 010 9 10 10 200 7 10 10 252 001 9 10 10 2 97 000 012 7 01 000 101 002339 Table 29 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329 -183 3M T- 6295 PAGE: 3 TABLE INCLUDES: SEX=ALL;GROUP=l, 5;WEEKS=ALL DEATH=3 ;FIND=ALL ;SUBSET=ALL -- 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: -5- -5- 1 O1 H1 H 11 1 O1 H rH I 11 ORGAN AND FINDING DESCRIPTION NUMBER: 9 10 ** FROM PREVIOUS PAGE ** PANCREAS (PA) .................................. 10 NOT REMARKABLE: 3 9 10 10 297 --NECROSIS / INFLAMMATION, ADIPOSE TISSUE 0010 ADRENAL, CORTEX (AC) ................................NUMBER EXAMINED: 10 NOT REMARKABLE: 2 9 10 10 210 -- UNILATERALLY EXAMINED --INFILTRATE, MACROPHAGE, PIGMENTED --HEMORRHAGE --HYPERTROPHY, CORTICAL CELL --VACUOLATION, DIFFUSE --DEGENERATION, CYSTIC / HEMORRHAGIC --HYPERPLASIA, CORTICAL 0010 64 5 8 0010 23 03 0100 0 04 1 0001 ADRENAL, MEDULLA (MA) .......................... 10 NOT REMARKABLE: 10 9 10 10 999 -- UNILATERALLY EXAMINED 0011 LN, MESENTERIC (MS) ............................ 10 NOT REMARKABLE: 10 9 10 10 8 10 10 -- HEMORRHAGE 0100 002340 Table 29 Incidence of Microscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 4 TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=3 ;FIND=ALL ;SUBSET=ALL i ORGAN AND FINDING DESCRIPTION -- N U M B E R - O F - A N I M A L S SEX: -- MALE-- -FEMALEGROUP: -1- -5- -1- -5NUMBER: 10 9 10 10 A F F E C T E D -- OVARY (OV) ................................ NOT REMARKABLE: -- CYST TESTIS (TE) ............................... ......... NUMBER EXAMINED: NOT REMARKABLE: --ATROPHY/DEGENERATION --GRANULOMA, SPERM BONE, FEMUR (FE) .......................... ......... NUMBER EXAMINED: NOT REMARKABLE: 0 0 0 10 8 2 1 10 10 0 10 10 0 9 10 010 900 900 000 000 9 10 10 9 10 10 MARROW, FEMUR (FM) ........................ ......... NUMBER EXAMINED: NOT REMARKABLE: -- HYPOCELLULAR, MARROW -- HYPERPLASIA, MYELOID, MARROW MARROW, STERNUM (SE) ...................... ......... NUMBER EXAMINED: NOT REMARKABLE: --HYPERPLASIA, MYELOID, MARROW --HYPOCELLULAR, MARROW 10 5 5 0 10 9 0 1 9 10 10 6 10 8 301 001 9 10 10 9 10 9 001 000 Table 29 Incidence of Microscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL ;GROUP=l,5;WEEKS=ALL DEATH=3 :FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION -- N U M B E R - O F - A N I M A L S SEX: --MALE-- -FEMALEGROUP: -1- -5- -1- -5NUMBER: 10 9 10 10 BONE, STERNUM (SB) NUMBER EXAMINED: 10 NOT REMARKABLE: 10 9 10 10 9 10 10 SPINAL CORD (SC) THYMUS (TH) -- HEMORRHAGE -- DEPLETION, LYMPHOCYTIC -- M-THYMIC CARCINOMA -- CYST LUNG (LU) -- CONGESTION -- EDEMA, PERIVASCULAR -- MINERALIZATION, VASCULAR -- HEMORRHAGE -- INFILTRATE, MACROPHAGE, ALVEOLAR --INFILTRATE, LYMPHOHISTIOCYTIC NUMBER EXAMINED: 10 NOT REMARKABLE: 10 NUMBER EXAMINED: 7 NOT REMARKABLE: 5 2 2 0 0 NUMBER EXAMINED: 10 NOT REMARKABLE: 4 1 3 1 1 0 1 9 10 10 9 10 10 8 10 27 9 6 322 310 100 001 9 10 10 344 000 322 310 121 124 132 Covance3M63T29-6-128935 PAGE: 5 A F F E C T E D -- 002341 Table 29 Incidence of Microscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL ;GROUP=1,5 ;WEEKS=ALL DEATH=3 ;FIND=ALL; SUBSET=ALL ORGAN AND FINDING DESCRIPTION HEART (HT) ..................... --CARDIOMYOPATHY --HEMORRHAGE MUSCLE, SKELETAL (SM) .......... NERVE, SCIATIC (SN) ............ TRACHEA (TR) ................... ESOPHAGUS (ES) ................. THYROID (TY) ................... -- HYPERPLASIA, C-CELL -- M-CARCINOMA, FOLLICULAR CELL SEX: --MALE-- -FEMALEGROUP: -1- -5- -1- -5NUMBER: 10 9 10 10 NUMBER EXAMINED: 10 NOT REMARKABLE: 7 3 0 NUMBER EXAMINED: 10 NOT REMARKABLE: 10 9 10 10 5 8 10 420 100 9 10 10 9 10 10 NUMBER EXAMINED: 10 NOT REMARKABLE: 10 9 10 10 9 10 10 NUMBER EXAMINED: 10 NOT REMARKABLE: 10 9 10 10 9 10 10 NUMBER EXAMINED: 10 9 9 10 NOT REMARKABLE: 10 9 9 10 NUMBER EXAMINED: 10 NOT REMARKABLE: 8 1 1 9 10 10 9 10 10 000 000 C o v a n c e 3M6 3T2 9- 6- 128935 PAGE: 6 002342 Table 29 Incidence of Microscopie Observations Week. 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL,-GROUP=l, 5;WEEKS=ALL DEATH=3 ;FIND=ALL; SUBSET=ALL ORGAN AND FINDING DESCRIPTION -- N U M B E R - O F - A N I M A L S SEX: -- MALE-- -FEMALE- GROUP: -1- -5- -5- NUMBER: 10 9 10 1 O1 H H1 11 PARATHYROID (PT) .......................... 10 NOT REMARKABLE: 10 9 10 10 9 10 10 PITUITARY (PI) ............................ -- B-ADENOMA -- HYPERPLASIA -- ANGIECTASIS HARDERIAN GLAND (HG) ...................... -- INFILTRATE, LYMPHOHISTIOCYTIC SALIV GL, MANDIB (SG) ..................... 10 NOT REMARKABLE: 4 4 2 1 10 NOT REMARKABLE: 10 0 10 NOT REMARKABLE: 10 9 10 10 8 55 142 114 033 9 10 10 8 99 111 9 10 10 9 10 10 STOMACH, GL (ST) .......................... --EDEMA -- INFLAMMATION, ACUTE -- CONGESTION -- EROSION 10 NOT REMARKABLE: 9 0 1 0 0 9 10 10 7 8 10 010 020 100 100 Covance 6329-183 3M T-6295 PAGE: 7 A F F E C T E D -- 02343 O 002344 Table 29 Incience of Microscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329 -183 3M T- 6295 PAGE: 8 TABLE INCLUDES: SEX=ALL;GROUP=l, 5;WEEKS=ALL DEATH=3 ;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- -5- -1- -5NUMBER: 10 9 10 10 STOMACH, NONGL (SU) ........... --ACANTHOSIS / HYPERKERATOSIS DUODENUM (DU) ................. NUMBER EXAMINED: 10 NOT REMARKABLE: 9 1 NUMBER EXAMINED: 10 NOT REMARKABLE: 10 9 10 10 9 10 10 000 9 10 10 9 10 10 JEJUNUM (JE) .................. ILEUM (IL) .................... NUMBER EXAMINED: 10 NOT REMARKABLE: 10 NUMBER EXAMINED: 10 NOT REMARKABLE: 10 9 10 10 9 10 10 9 10 10 9 10 10 CECUM (CE) .................... NUMBER EXAMINED: 10 NOT REMARKABLE: 10 9 10 10 9 10 10 COLON (CO) NUMBER EXAMINED: 10 NOT REMARKABLE: 10 9 10 10 9 10 10 Table 29 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 9 TABLE INCLUDES: SEX=ALL;GR0UP=1,5;WEEKS=ALL DEATH=3 ;FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION NUMBER-OF SEX: -- MALE-- -FEMALE- GROUP: -1- -5- -5- NUMBER: 10 9 10 A N I M A L S - A F F E C T E D -- 1 o1 1 RECTUM (RE) .................................. --PARASITISM SKIN (SK) .................................... -- ACANTHOSIS/HYPERKERATOSIS -- INFLAMMATION, CHRONIC-ACTIVE --ULCERATION -- HEMORRHAGE --DEGENERATION, MUSCLE, SUBCUTANEOUS MAMMARY, FEMALE (MF) ......................... --CYST / GALACTOCELE -- HYPERPLASIA, GLANDULAR --SECRETORY MATERIAL -- M-FIBROSARCOMA URINARY BLADDER (UB) ......................... -- INFILTRATE, LYMPHOHISTIOCYTIC --PROTEINACEOUS MATERIAL, LUMINAL 10 NOT REMARKABLE: 10 0 10 NOT REMARKABLE: 10 0 0 0 0. 0 0 NOT REMARKABLE: 0 0 0 0 0 10 NOT REMARKABLE: 7 3 0 9 10 10 7 10 10 200 9 10 10 9 8 10 020 020 020 010 010 0 10 10 032 032 044 065 010 9 10 7 10 9 8 001 200 02345 O Table 29 Incidence of Microscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS=ALL DEATH=3 ;FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION -- N U M B E R - O F - A N I M A L S SEX: -- MALE-- -FEMALEGROUP: -1- -5- -1- -5NUMBER: 10 9 10 10 UTERUS (UT) ............................... -- DILATATION CERVIX (CV) ................................ --CYST, SQUAMOUS VAGINA (VA) ................................ NOT REMARKABLE: NOT REMARKABLE: NOT REMARKABLE: 0 0 0 0 0 0 0 0 0 10 10 0 10 7 0 03 0 10 10 0 9 10 010 0 10 0 10 9 9 PROSTATE (PR) .............................. 10 9 0 0 NOT REMARKABLE: 4 6 0 0 -- INFLAMMATION, CHRONIC-ACTIVE -- INFILTRATE, LYMPHOHISTIOCYTIC 53 00 1000 SEMINAL VESICLES (SV) ..................... ......... NUMBER EXAMINED: 10 9 0 0 NOT REMARKABLE: 10 9 0 0 EPIDIDYMIDES (EP) ......................... -- IMMATURE SPERM FORMS ** CONTINUED ON NEXT PAGE ** 10 9 0 0 NOT REMARKABLE: 9 7 0 0 0100 C o v a n c e 3M6 3T2 9-6- 128935 PAGE: 10 AFFECTED -- 002346 11 1lVo-* Wt 002347 Table 29 Incidence of Microscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS covance 6329 -183 3M T- 6295 PAGE: 11 TABLE INCLUDES: SEX=ALL;GROUP=l, 5;WEEKS=ALL DEATH=3 ;FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION ** FROM PREVIOUS PAGE ** EPIDIDYMIDES (EP) ............................ --INFILTRATE, LYMPHOHISTIOCYTIC HEMATO NEOPLASIA (HN) ....................... -- 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- -5- NUMBER: 10 9 10 NOT REMARKABLE: NOT REMARKABLE: 10 9 1 10 10 900 700 100 9 10 10 9 10 10 CAUSE OF DEATH (CD) ......................... --SCHEDULED SACRIFICE LN, MEDIASTINAL (ML) ................. ...... . 10 NOT REMARKABLE: 0 10 0 NOT REMARKABLE: 0 9 10 10 000 9 10 10 000 000 LN, AXILLARY (AX) ........................... 0000 NOT REMARKABLE: 0 0 0 0 LN, INGUINAL (IN) ........................... -- INFILTRATE, MACROPHAGE, PIGMENTED -- HEMORRHAGE 0010 NOT REMARKABLE: 0 0 0 0 0010 0010 Table 29 Incidence of Microscopie Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 12 TABLE INCLUDES: SEX=ALL;GROUP=l,5;WEEKS::ALL DEATH=3 ;FIND=ALL; SUBSET=ALL ORGAN AND FINDING DESCRIPTION -- 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- -5- -1- -5NUMBER: 10 9 10 10 LN, OTHER (LN) ............. NUMBER EXAMINED: 0 0 0 0 NOT REMARKABLE: 0 0 0 0 LN, RENAL (RL) ............. NUMBER EXAMINED: 0 0 0 0 NOT REMARKABLE: 0 0 0 0 LN, MANDIBULAR (MN) ........ --HYPERPLASIA, PLASMACYTIC --HEMORRHAGE VERTEBRA/MARROW (VT) ....... NUMBER EXAMINED: 1 0 2 1 NOT REMARKABLE: 0 0 0 0 002 0 1021 NUMBER EXAMINED: 0 0 0 0 NOT REMARKABLE: 0 0 0 0 MAMMARY, MALE (MM) ......... NUMBER EXAMINED: 0 0 0 0 NOT REMARKABLE: 0 0 0 0 COAGULATING GL (CG) ........ NUMBER EXAMINED: 0 0 0 0 NOT REMARKABLE: 0 0 0 0 02348 O 002349 Table 29 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CHRONIC TOXICITY AND CARCINOGENICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IN RATS Covance 6329-183 3M T-6295 PAGE: 13 TABLE INCLUDES: SEX=ALL ;GROUP=1,5 ;WEEKS=ALL DEATH=3 ;FIND=ALL ;SUBSET=ALL ORGAN AND FINDING DESCRIPTION TAIL <TI) ................... ** END OF LIST * -- N U M B E R - O F - A N I M A L S - A F F E C T E D --SEX: --MALE-- -FEMALEGROUP: -1- -5- -1- -5NUMBER: 10 9 10 10 NOT REMARKABLE: 0 0 0 0 Covance 6329-183 3MT-6295 Table 30 Results of HoMmixoegden3e/i1ty8/A98nalyses (ppm) 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DIYNWRAITTHS PERFLUOROOCTANE T-6295 (ppm) Samples Location Replicate 0.5 20 Top 1 Me2an 0.605 00..559887 (119)" 2211..34 21.4 (107) Middle 1 2 Mean 0.657 00..669704 (135) 2233..56 23.6(118) Bottom 21 00..660311 2240..64 Mean 0.616 (123) 22.5 (113) a Each value in parenthesis is the percent of theoretical 002350 Table 30 (Continued) Covanc3eM63T2-96-219853 Results of HoMmioxgeden4e/i1ty6/A98nalyses (ppm) 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DIYNWRAITTHS PERFLUOROOCTANE Sample Location Replicate 0.5 T-6295 (ppm) 25 20 Top 21 M3ean 0.743 2.22 00..542016 22..0132 0.557 (111)8 2.12 (106) 55..4386 44..9064 (99.2) 1187..14 1188..40 (90.0) Middle 21 Me3an 00..447788 0.486 2.28 22..0019 4.90 45..2980 211199...357 0.481 (96.2) 2.13 (107) 5.03 (101) 20.2 (101) Bottom 21 00..595159 22..0034 45..7000 1187..76 M3ean 00..631519 (122) 11..9874 (98.5) 44..8984 (97.6) 1188..42 (91.0) a Each value in parenthesis is the percent of theoretical. 002351 Table 30 (Continued) Covance 6329-183 3M T-6295 Results of Homogeneity Analyses (ppm) Mixed 6/18/98 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(EPFNOICSI;TTY-6S2T9U5)DIYNWRAITTHS PERFLUOROOCTANE Sample Location Replicate 0.5 T-6295 (ppm) 25 20 Top 1 23 Mean 0.566 001...98150754 (175) 222...732138 2.44 (122) 4.87 45..9180 4.98 (99.6) 2108..37 1198..26 (96.0) oH cr Middle 1 0.483 - _ _ 23 00..440810 - - - Mean 0.455 (91.0) - - - 1 23 Mean 0.617 00..663375 0.630 (126) 2.50 22..1015 2.22(111) 55..1453 45..7009 (102) 1187..83 18.2 18.1 (90.5) Bottom 21 M3ean 00..664904 00..563222 (124) 232...402189 2.59 (130) 5.08 55..1152 5.12 (102) 19.4 2108..52 19.4 (97.0) a Each value in parenthesis is the percent of theoretical, b Reassay. 002352 Table 30 (Continued) Covance 6329-183 3M T-6295 Results of Homogeneity Analyses (ppm) Mixed 04/22/98 104-WEEK DIETARY CSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DIYN WRAITTHS PERFLUOROOCTANE Sample Location Replicate T-6295 (ppm) 20 Top 1 18.9 Me2an 18.4 18.7 (93.5)a Middle 1 Me2an 211099...169 (99.5) Bottom 1 21.1 2 20.1 Mean 20.6 (103) a Each value in parenthesis is the percent of theoretical. 002353 Covarice 6329-183 3M T-6295 Table 31 Results of Stability Analyses (ppm) Mixed 3/18/98 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T95U)DIYNWRAITTHS PERFLUOROOCTANE Storage Conditions Replicate 0.5 T6295 (ppm) 1.0 2.0 20 Initial8 21 Mean 0.657 00..669704 (135)b 1.15 11..5313 (133) 22..6279 2.48 (124) 23.6 2233..56(118) t2e8mdpaeyrsa,turoreom 1 Me2an 00..550574 0.531 (106) 011...9101327(102) 21..0914 1.98 (99.0) 222000...878 (104) a Rmeisdudlltes ofofrththeed0o.s5e-parnedpa2r0a-tiloenvselfsowr heoremdoegreivneedityfraonmalythseis,sample collected from the b Each value in the parenthesis is the percent of theoretical. 002354 Covance 6329-183 3M T-6295 Table 31 (Continued) Results ofMStiaxbeidlit4y/1A6n/9a8lyses (ppm) 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DIYNWRAITTHS PERFLUOROOCTANE Storage Conditions Replicate 0.5 T6295 (ppm) 1.0 2.0 20 Initial8 231 Mean 0.478 00..447886 0.481 (96.2)b 22..0218 22..0193(107) 44..9900 55..2083 (101) 19.7 2119..35 20.2 (101) 33 days, room temperature 21 Mean 0.527 00..555430 (108) 2.57 5.64 28.4 22..5564 (128) 5.83 5.74(115) 22.1 25.6 (128) a Results were derived from the sample collected from the middle of the dose b Epraecpharvaatliuoensinfothrehpoamreongtehneesiitsyisanthaleyspiesrcent of theoretical 002355 Covanc3eM63T2-96-219853 Table 32 Results of Dose Preparation Analysis (ppm) 104-WEEK DIETARY CSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DIYN WRAITTHS PERFLUOROOCTANE Mix Date Replicate 0.5 T-6295 (ppm) 1.0 2.0 20 3/18/98 1 Me2an 00..665970 0.674 (135)b 11..5115 1.33 (133) 222...624798 (124) 2233..56 23.6 (118) a Results for the 0.5- and 20- levels were derived from the sample collected from the middle of the dose preparations for homogeneity b Eanaaclhysvisa.lue in the parenthesis is the percent of theoretical. 002356 Covanc3eM63T2-96-219853 Table 32 (Continued) Results of Dose Preparation Analysis (ppm) 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DIYNRWAITTHS PERFLUOROOCTANE Mix Date Replicate 0 0.5 T-6295 (ppm) 2.0 5.0 20 4/16/988 1 b 2b M3ean - 0.478 2.28 00..447886 0.481 (96.2)c 222...001193(107) 44..9900 5.28 5.03 (101) 19.7 2119..35 20.2 (101) 4/23/98 1b 2b Mean - 00..337759 0.377 (75.4) 21..0776 46..9524 1.92 (96.0) 5.73 (115) 221109...369 (103) 4/23/98d 1 _ 2 Mean - 0.674 0.535 0.605 (121) - 0.780 4.78 2.78 (55.6) - 4/23/986 1 Me2an - 0.517 _ 00..440662 (92.4) - 456...531524 (107) _ - 4/30/98 1b 2b Mean - 00..545718 0.515 (103) 2.12 2.11 2.12 (106) 5.55 6.03 5.79(116) 222222...164(112) 4/30/98d 1 2 Mean - - _ 5.24 _ - 5.24 5.24(105) - a Results for the 0.5-, 2.0-, 5.0- and 20-ppm levels were derived from the sample cbcolEBflreaeocclmtohewdvthatehluemeliiidnmdtilhteeoofpfqaturheaenndtthiotesasetiisopinrse(pt<hae0ra.p4tieoprnpcsemnf)to, or fhtohmeoorgeetniceailt,y analysis, de RReetaesnstaiyo,n. 002357 Covance 6329-183 3M T-6295 Table 32 (continued) Results of Dose Preparation Analysis (ppm) 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T95U)DIYNWRAITTHS PERFLUOROOCTANE Mix Date Replicate 0 0.5 T-6295 (ppm) 2.0 5.0 20 5/7/98 1 M2ean 00..996422 0.952 0.406 0.390 0.398 (79.6)c 1.73 1.74 1.74 (87.0) 4.37 4.31 4.34 (86.8) 111888...222 (91.0) 5/7/98d 1 1.11 0.202 2 1.12 0.557 - Mean 1.12 0.380 (76.0) - _ - _ - 5/7/98' 1 b 0.476 _ _ _ 2b Mean - 0.347 0.412 (82.4) - -- - 5/14/98 1b M2ean b- 0.474 2.52 5.48 19.8 00..440328 (87.6) 22..5543 (127) 55..2076 (105) 2210..57 (104) 5/21/98f 1 <0.75 0.157 1.60 4.98 19.6 2 <0.75 0.349 1.86 6.27 20.9 Mean - 0.253 (50.6) 1.73 (86.5) 5.63 (113) 20.3 (102) 5/21/98d 1 b 2b Mean - 0.248 . 0.326 0.287 (57.4) - - - 5/28/98 1 b 0.442 1.95 6.19 2 b 0.453 2.29 6.49 b Below the Mean limit of q u a-n tita tio 0.448 (89.6) n (<0.4 ppm), 2.12(106) 6.34 (127) c Each value in the parenthesis is the percent of theoretical, d Reassay, e Retention. f The low standard (0.4 ppm) was not used for the calibration curve. 21.8 2222..13 (111) 002358 Covanc3eM63T2-96-219853 Table 32 (continued) Results of Dose Preparation Analysis (ppm) 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DINYWRAITTHS PERFLUOROOCTANE Mix Date Replicate 0 0.5 T-6295 (ppm) 2.0 5.0 20 6/4/98g 1b 2b Mean - 0.618 0.610 0.614 (123)c 1.95 1.66 1.81 (90.5) 455...931195 (103) 18.2 2109..33 (96.5) 6/11/988 21 bb Mean - 0.446 2.25 5.22 19.0 00..543993 (98.6) 21..0918 (104) 45..8012 (100) 1168..90 (90.0) 6/18/98" 1 b 2b M3ean - 00..663177 22..1510 55..1453 1187..38 0.635 0.630 (126) 22..0252(111) 45..0790 (102) 18.2 18.1 (90.5) 7/16/98 1b 2b Mean - 000...555146924 (108) 111...769500 (87.5) 443...109320 (80.4) 1177..94 17.7 (88.5) 7/16/98d 1 _ M2ean -- . -- _ 4.76 _ - 5.41 5.09 (102) - 8/13/98 1b 2b Mean - 00..457689 0.524 (105) 22..0074 2.06 (103) 455...962508 (106) 1198..99 19.4 (97.0) a Results for the 0.5-, 2.0-, 5.0- and 20-ppm levels were derived from the sample cb EBcoaelcllohewcvteathdlueferloiinmmtihttheoefpqmaurieadnndtthlieteasotiifsotnihse(t<hd0eo.sp4eeprppcremenp)ta, roafttihoenosrfeotirchaol,mogeneity analysis, dg RReeaassssaayy.ed due to unacceptable calibration curve for original assays. 002359 Covance 6329-183 3M T-6295 Table 32 (continued) Results of Dose Preparation Analysis (ppm) 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T95U)DIYNWRAITTHS PERFLUOROOCTANE Mix Date Replicate 0 0.5 T-6295 (ppm) 2.0 5.0 20 9/10/98 1b 2b Mean - 02..42787 1.38 (276)c 222...222357 (113) 44..5684 4.61 (92.2) 17.1 16.8 17.0 (85.0) 9/10/98d 1 _ 2- Mean - 0.213 .. 0.231 0.222 (44.4) - _ - _ - - 9/10/98' 1_ M2ean - 1.09 11..2178 (236) _ - _ - _ - 9/10/98d'6 1 2 Mean - b b - -_ --- _ - 9/10/98f 1 Me2an _ - 0.475 _ 00..433816 (86.2) - - _ - 10/8/98 1b 2b Mean - 0.836 1.79 5.68 17.9 0.482 0.659 (132) 11..8813 (90.5) 45..9290 (106) 1177..26 (88.0) bc EBaeclohwvatlhueeliinmtiht eofpqaureanntthiteastiisoins (t<he0.p4eprpcemn)t, of theoretical, fde RRReeeataesssnsataiyyo,no.f the retention. 002360 Covance 6329-183 3M T-6295 Table 32 (continued) Results of Dose Preparation Analysis (ppm) 104-WEEK DIETARY CSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DINY RWAITTHS PERFLUOROOCTANE Mix Date Replicate 0 0.5 T-6295 (ppm) 2.0 5.0 20 10/8/98d 1 b 2 Mean - 0.649 (130)c - -- -- -- 10/8/98* 1 _ 0.473 _ Me2an - 1.02 0.747 (149) - - -- 10/8/98f 1 _ 0.474 __ 2 Mean - 0.497 0.486 (97.2) - - - 11/5/98 1b 2 Mean b- 0.546 1.84 4.33 16.3 0.556 0.551 (110) 2.05 1.95 (97.5) 44..3459 (87.8) 15.4 15.9 (79.5) 12/3/98 1b 2b Mean - b b - 11..6551 33..8669 1146..66 1.58 (79.0) 3.78 (75.6) 15.6 (78.0) 12/3/98d 1 M2ean - - 0.607 1.98 00..553793 (115) 11..6894(92.0) - - b Below the limit of quantitation (<0.4 ppm), dc ERaecahssvayal.ue in the parenthesis is the percent of theoretical, efg RRGeeratoesunspatiyownoi.lfltrheeasrseateynetdiodnue to unacceptable chromatography. 002361 Table 32 (continued) Covance 6329-183 3M T-6295 Results of Dose Preparation Analysis (ppm) 104-WEEK DIETARY CSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DINY WRAITTHS PERFLUOROOCTANE Mix Date Replicate 0 0.5 T-6295 (ppm) 2.0 5.0 20 12/31/98 1b 2b Mean - 0.339 00..229436 (58.6)c 1.89 1.69 1.79 (89.5) 4.42 4.71 4.57 (91.4) 1199..04 19.2 (96.0) 12/31/98d 1 _ 0.442 _ _ Me2an - 0.422 0.432 (86.4) - - - 1/28/99 1b 2b Mean - e e - 1.67 21..0856 (93.0) 44..7912 4.82 (96.4) 1177..16 17.4 (87.0) 1/28/99" 21 Mean - b b - __ - -- -- 1/28/99" 1 M2ean - bb - _ __ - -- -- 2/25/99 1 1.498 ' 0.907 2.06 5.67 20.1 2 b 0.852 6.79 7.48 20.1 Mean - 0.880 (176) 4.43 (222) 6.58 (132) 20.1 (101) 2/25/99" Me21an b bb 0.450 1.64 4.91 _ 00..458286 (97.6) 21..0865 (92.5) 4.56 4.74 (94.8) - cb EBaeclohwvatlhueeliinmtiht eofpqaureanntthiteastiisonis (t<h0e.p4eprpcemn)t, of theoretical, ed TRheiasssleavye. l was outside of the modified standard curve and will be retested. 002362 Covanc3eM63T2-96-219853 Table 32 (continued) Results of Dose Preparation Analysis (ppm) 104-WEEKDIETARYCSHURLOFNOINCICTOAXCIICDITPYOTAANSDSICUAMRCSAINLOTG(PEFNOICSI;TTY-6S2T9U5)DINYWRAITTHS PERFLUOROOCTANE Mix Date Replicate 0 0.5 T-6295 (ppm) 2.0 5.0 20 3/25/99 1b 2b Mean - 0.414 (82.8)c 1.91 b 2.97 - 2.44 (122) 3/25/99d 1 2 Mean _ - 01..76302 21..1918 1.17 (234) 2.05 (103) 4/22/99 1b 2b Mean - b b - 21..0974 2.01 (101) 4/22/99d 21 Mean _ - 0.431 _ 0.405 0.418 (83.6) - 5/20/99 1b 2b Mean - 0.582 00..553517 (111) 11..6786 1.72 (86.0) bc EBaeclohwvathlueeliinmtiht eofpqarueanntthiteastiisoins (t<h0e.p4eprpcmen)t, of theoretical, d Reassay. 5.44 5.59 5.52 (110) - 45..7732 5.23 (105) 5.06 4.90 4.98 (99.6) 44..6675 4.66 (93.2) 1189..59 19.2 (96.0) _ - 17.7 1188..83 (91.5) _ - 2107..18 19.0 (95.0) 002363