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