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PaW~ and lbtcoiogy RikerLaborntorkmI6nc. Buildi2n7g0-3S-035M, Ceriter SL Paul.Minnesota55144-100() TWO YEAR ORAL (DIET) TOXICITY / CARCINOGENICITY STUDY OF FLUOROCHEMICAL FC-143 IN RATS (RIKER EXPERIMENT No. 0281CROO12) VOLUME 1 OF 4 CONDUCTED APRIL, 1981 DURING - MAY, 1983 RIKER LABORATORIES, INC. / 3M COMPANY ST. PAUL, MINNESOTA 55144-100D U.S.A. STUDY REPORT AMENDMENT NO. I EFFECTIVE DATE: NOVEMBER 2, 1987 Study Title: Two Year Oral (Diet)Toxicity/OncogenicityStudy of Fluorochemical FC-@'143in Rats RIKER Experiment No.: 0281CROO12 The Table of Contents and the titles for individualclinical chemistry values for the males (Table 14; pages 66-70) and females (Table 15; pages 73-77) should read "Individual Plasma Chemistry Values" Reason: This was an inadvertenttypographicalerror only and does not change the interpretationof the clinical data. Approval: L.J. Sibinski Date Study Director TWO YEAR ORAL (DIET)TOXICITY/CARCINOGENICITY STUDYOF FLUOROCHEMICAFLC-143IN RATS (RIKER Experiment No. 0281CROO12) TABLE OF CONTENTS PAGE(S) REPORT SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . I INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 MATERIALS AND METHODS . . . . . . . . . . . . . . . . . . . . . . . 4 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 PRINCIPAL PERSONNEL LIST . . . . . . . . . . . . . . . . . . . . . . 26 SIGNATURE PAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 REPORT TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . 29-92 TABLE 1 - Analysis of FC-143 in the Diet . . . . . . . . . . . 29 TABLE 2 - Summary of Mean Body Weights - Males . . . . . . . . . . . . . . . . . . . . . . . 30 TABLE 3 - Summary of Mean Body Weights - Females . . . . . . . . . . . . . . . . . . . . . . 32 TABLE 4 - Summary of Mean Feed Consumption Per Kilogram Body Weight - Males . . . . . . . . . . 34 TABLE 5 - Summary of Mean Feed Consumption Per Kilogram Body Wei-ght- Females . . . . . . . . . 36 TABLE 6 - Summary of Mean Absolute Feed Consumption - Males . . . . . . . . . . . . . . . . . . . . . . . 38 TABLE 7 - Summary of Mean Absolute Feed Consumption Females . . . . . . . . . . . . . . . . . . . . . . 40 TABLE 8 - Estimated Mean FC-143 Consumption In Milligrams Per Kilogram Per Day . . . . . . . . . . 42 TABLE OF CONTENTS - Continued PAGE(S) TABLE 9 - Mortality Data . . . . . . . . . . . . . . . . . . . 44 TABLE 10 - Summary of Clinical Signs . . . . . . . . . . . . . 46 TABLE 11 - Summary of Ophthalmologic Changes . . . . . . . . . 48 TABLE 12 - Mean and Individual Hemogram Values - Males . . . . 50 TABLE 13 - Mean and Individual Hemogram Values - Females . . . 57 TABLE 14 - Mean and Individual Serum Chemistry Values Males . . . . . . . . . . . . . . . . . . . . . . . 64 TABLE 15 - Mean and Individual Serum Chemistry Values Females . . . . . . . . . . . . . . . . . . . . . . 71 TABLE 16 - Urinalysis Values . . . . . . . . . . . . . . . . . 78 TABLE 17 - Individual Organ Weight, And Absolute Mean Organ L Weights, Mean Organ Relative Percent To Whole Body Weight, And Organ To Brain Weight Ratios At One Year . . . . . . . . . . . . . . . . . . . . . . 81 TABLE 18 - Individual Organ Weight, And Absolute Mean Organ Weights, Mean Organ Relative Percent To Whole Body Weight, And Organ To Brain Weight Ratios At Two Years . . . . . . . . . . . . . . . . . . . . . 86 TABLE 19 - Summary of Major Microscopic Findings - Neoplastic Lesions . . . . . . . . . . . 91 TABLE 20 - Summary of Major Microscopic Findings - Non-Neoplastic Lesions . . . . . . . . . 92 REPORT FIGURES . . . . . . . . . . . . . . . . . . . . . . . . . . . 93-96 FIGURE 1 - Mean Body Weights - Males . . . . . . . . . . . . . 93 FIGURE 2 - Mean Body Weights - Females . . . . . . . . . . . . 94 FIGURE 3 - Mean Feed Consumption Per Kilogram Mean Body Weight - Males . . . . . . . . . 95 FIGURE 4 - Mean Feed Consumption Per Kilogram Mean Body Weight - Females . . . . . . . . 96 TABLE OF CONTENTS - Continued PAGE(S) APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97-1223 ITEM A - Air Monitoring of ArtimalRooms . . . . . . . . . . . 98 ITEM B - Diet Analytical Data Sheets . . . . . . . . . . . . 103 ITEM C - Acceptable Ranges for Clinical Pathology Parameters . . . . . . . . . . . . . . . . 116 ITEM D - Histopathologic Examination and Pathology Report by Dr. Robert G. Geil, ExternalConsultant Veterinary Pathologist . . . . . . . . . . . . . . . 119 ITEM E - BiostatisticalAnalysis Procedures . . . . . . . . . 407 ITEM F - Summary of Mean Body Weights and Individual Animal Body Weight and Feed Jar Weight Data . . . . . . . . 411 ITEM G - Ophthalmoscopic Evaluation and Data by Dr. Stephen I. Bistner, External Consultant Veterinary Ophthalmologist . . . . . . . . . . . . . 1203 ITEM H - Copy of the Study Protocol with Amendments . . . . . 1206 ITEM I - Quality Assurance Unit Statement . . . . . . . . . . 1214 ITEM J - Chemical Analyses of FC-143 and Stability Analyses of FC-143 in Diet . . . . . . . . . . . . . 1215 TWO YEAR ORAL (DIET)TOXICITY/ONCOGENICITY STUDYOF FLUOROCARBONFC-143 IN RATS (RIKERExperimentNo. 0281CROO12) REPOR@ SUMMARY The purpose of this study was to assess the potential toxicity and oncogenicity of FC-143 (ammonium perfluoroalkylcarboxylate)mixed in the diet and fed to 50 rats per sex per group for two years. An interim sacrifice and evaluation was performed at one year on 15 additional rats per sex from the control and high-dose groups. A total of 360 Sprague-Dawley male and female rats were assigned to three experimental groups. The FC-143-treatedgroups were fed diets containing either 300 or 30 ppm of FC-143 for two years, while a control gr6up received only untreated feed. In-life observations performed during the course of the study included: daily observations for abnormal signs; periodic physical examinations;body weight and feed consumption; ophthalmoscopic examinations; and clinical pathology including hematology,clinical chemistry and urinalysis. Macroscopic postmortem examinations were performed on all animals that died or were terminatedprior to the end of the scheduled dosing. Selected organ weights were obtained from all of the rats necropsied at 1 year as well as from 15 rats/sex/group,randomly selected from the control and both FC-143-treatedgroups, at the terminationof the study. Selected tissue specimens were harvested from each -animal at necropsy, and preserved for future histopathologicexamination. Microscopic evaluation was performed on all tissues saved from all of the control and high-dose rats, while a similar evaluationwas performed on a modified list of tissues obtained from the low-dose animals. The major in-life findings associatedwith FC-143 administrationconsisted of: a dose-related decrease in mean body weight and a treatment-related increase in feed consumption per kilogram of mean body weight in males; and a slight treatment-related increase in the incidence of ataxia in the females. There was no increase in mortality in the high-dose treatment group when compared to similar values for the control population. FC-143 related hematologic changes in both treated groups consisted of a decrease in red blood cell counts, hemoglobin concentrationand hematocrit values at various times throughout the study. Generally, these hematology parameters remained within the acceptable ranges for the rat. The primary FC-143 associated changes were found in the liver. These alterations were characterized by increased liver weights, hepatomegalocytosiswith vacuolation of the cytoplasm, and some evidence of hepatocellulardegenerationwith occasionalsigns of necrosis. These liver changes were found early in the study and showed very little evidence of progression at the end of two years. L The incidence of almost all neoplasms in this study was relativelylow, and the types and incidence of neoplasms were generally not different from those commonly found in geriatric Sprague-Dawley rats. Hepatocellular tumors were very slightly increased in the high-dose male rats. The other neoplasms in this study were associated with endocrine and/or endocrinesensitive organs. The increased incidence of mammary or testicular tumors in the high- and low-dose groups was not statisticallysignificantand/or was similar to the spontaneous incidence reported for Sprague-Dawleyrats. Under the conditionsof this study and based on tumor incidence,types of tumors, time of tumor appearance,and the survival rate at two years, FC-143 is not consideredto be carcinogenic in the rat. 2. TWO YEAR ORAL (DIET)TOXICITY- CARCINOGENICITY STUDYOF FLUOROCHEMICAFLC-143IN RATS INTRODUCTION This study was designed to evaluate the chronic toxicologicand carcinogenic potential of FC-143, an industrial grade of ammonium perfluoroalkylcarboxylate,in rats followingoral administrationin the diet for a period of two years. The study was sponsored by the Commercial Chemical Division of 3M Company and was performed by the Pathology and Toxicology Department of Riker Laboratories, Inc., 3M Company, St. Paul, Minnesota, U.S.A. The study and subsequent reporting was coordinated for the sponsor by the 3M Corporate Toxicology Services staff. The in-lifeor dosing portion of the study began on April 21, 1981, and was completed on May 5, 1983. A copy of the study protocol with amendments is contained in this report as Appendix Item H. The study was designed to evaluate two separate fluorochemicals, FM-3924 and FC-143, using a common set of control animals. This report will describe the results of the FC-143 treatment while the results relating to the FM-3924 study will be reported separately. The study was conducted in accordance with the Department's Standard Operating Procedures (ie., SOPS) and in compliance with the Food and Drug Administration'sGood Laboratory Practice (GLP) regulations (21 CFR Part 58). Various phases of the study were inspected by the RIKER Quality Assurance Unit; their statement is presented in Appendix Item I of this report. The original signed protocol with amendments, list of study personnel, raw data, study specimens, and other pertinent study samples/documentswill be maintained within the Pathology and Toxicology Department archives currently located at 3M Center in St. Paul, Minnesota. 3. MATERIALSAND METHODS Test System: Three-hundredand sixtySprague-Dawleyrats [Crl:COBSR CD(SD)BR, Charles River, Portage, MI], 39 to 41 days of age when treatment began, were divided by means of a table of random numbers into three groups. The control and high-dose groups each contained 65 males and 65 females, whereas the low-dose group contained 50 male and 50 female rats. The rats were housed in hanging stainless steel cages with wire mesh floors and fronts. The males were housed individually, but the females were housed two per cage. The control animals were housed in separate rooms from those which received FC-143 in order to prevent a possible cross contaminationby potential vaporization and/or sublimation of the test article which has a finite vapor pressure at room temperature. Air samples were taken from each of the animal treatment rooms four months after the initiationof the study in order to assay for the presence of airborne contaminants. The samples were analyzed by the Analytical Section of the 3M Central Research Laboratory and were found to be below detectable limits for the suspected fluorochemicals. In additionto the air monitoring,30 untreated sentinel rats were placed in each of the two animal rooms. From each animal room, 5 male and 5 female sentinel rats were euthanized during the first week of the study, and at I and 3 months after the start of the study. Plasma samples obtained from these rats were analyzed for organic fluorine and were found to contain less than one part per million (see Appendix Item A). Each animal room was temperature and humidity controlled with the lighting on a 12 hour light/darkcycle. Individual rats were uniquely identified by an animal number on a cage card and on a tag affixed to their ear. Feed (Certified Purina Laboratory Chow, Ralston-Purina Co., St. Louis, MO) and tap water were provided ad libitu Test Substance/DietPreparation: FC-143 (Lot 37) was analyzed by the Commercial Chemicals Divisions (CCD) Analytical Laboratory prior to the start of the study, after approximatelyone year from the start of the study, and at the terminationof the dosing period. No detectable changes were found in the test substance during this time (see CCD Analytical Reports Nos. 308, 348 and 413 in Appendix Item J). 4. The test substancewas a white powder which was added (ie, stratified) directly into an appropriatequantity of untreateddiet and mixed in a Hobart R blender for approximately20 minutes for each separate batch. Prior to initiatingcompound administrationto any animals, the test substance/diet mixture was assayed. FC-143 was found to be uniformly blended and stable for one to two-weeks in the ground feed (see CCD Analytical Report No. 209 in Appendix Item J). Test article/dietmixtures were prepared fresh weekly during the study and representative samples of each were collected and assayed for test article content and homogeneityduring the first month of the study and at 3 month intervalsthereafter (see Appendix Item B). The results of these assays indicated that the level of FC-143 was generally within a few percentof that desired (Table 1). The rats received either FC-143 treated or control (ie, untreated) diets in glass jars 10.2 cm high x 8.9 cm in diameter. A 5.1 cm access hole was cut in the stainlesssteel lid. On a weekly basis the diet jars were removed and replaced with clean jars containing fresh diet mixtures." Experimental Design: The study consisted of one control group and two treatment groups. The dosage levels and animal distributionare listed hereinafter. Treatment Groups Dosage Levels (ppm) I - Control 0 5 - High 300 6 - Low 30 Group Size & Animal Numbers Males Females (An. Nos.) (An. Nos.) 65 (3516-3580) 65 (3581-3645) 50 (3646-3695) 65 (4576-464o) 65 (4641-4705) 50 (4706-4755) 5. An interim termination at one year involved 15 male and 15 female rats from both the control and high-dose groups. The remaining 50 animals per sex per group continued on study. In-Life Observations: All animals were observed daily throughout the two year dosing period. Weekly physical examinations included palpation for the presence of masses as well as observations for pharmacotoxicsigns; mortality was recorded daily. During the study, moribund animals were closely monitored, and euthanized when in the judgement of the Study Director death appeared to be imminent in order to harvest non-autolysed tissue for subsequent histopathologicexamination. Body weights and feed consumption were recorded once per week for the first six months, and then once every two weeks for the remainder of the study. Eye examinations using indirect ophthalmoscopy and/or slit lamp biomicroscopywere performed on the control and high-dose rats by the Staff Veterinarian prior to compound administrationand at approximately one year. The eyes of the surviving control and high-dose animals were examined 2-3 weeks prior to the terminationof the study by a consulting Veterinary Ophthalmologist(see Appendix Item G). Clinical pathology determinations included hematology, clinical (serum) chemistry and urinalysis. Tests were conducted on samples obtained from 15 rats per sex from each group at 3, 6, 12, 18 and 24 months; animals were randomly selected at each time interval. Hematologic tests included total red and white blood cell counts, hemoglobin, hematocrit, and a differentialwhite blood cell count. Clinical chemistry parameters included total bilirubin,total protein, albumin, blood urea nitrogen (BUN), glucose, alkaline phosphatase (AP), creatine phosphokinase (CPK), aspartate aminotransferase (AST-formerly known as SGOT), alanine aminotransferase (ALT-formerly SGPT), and calcium. Urine tests included pH, specific gravity, albumin, glucose, bilirubin, occult blood and ketones. Blood samples were collected from the retrobulbar venous plexus of anesthetized rats which had been fasted overnight. Blood was generally collected from the right eye. Urine samples were obtained by placing each rat in an individualmetabolism cage for 20-22 hours. The specific methods 6. used for hematology,clinical chemistry and urinalysis are outlined in Appendix C. The mean hematology and clinical chemistry values from the treated groups were compared to both the concurrent control group as well as normal ranges for these parameters obtained from historical control animal data generated in this laboratory (AppendixC). Metabolic Examination: Overnight (ie, about 24 hour) urine and fecal samples were collected at 2, 5, 11 and 23 months from five rats per sex per group for total organic fluorideanalysis, and for the presence of FC-143. At the scheduled one and two year necropsies, samples of liver, blood, kidney, spleen, lung and bone marrow (ie, from the femur) were saved from five rats/sex/group. After collection,all specimens were frozen pending subsequent analysis by the RIKER Drug Metabolism Department. Once these specimens are analyzed, a separate report regarding this experimental work will be prepared by the Drug Metabolism department. Postmortem Examinations: Gross postmortem L examinations were performed on all rats which died during the study and those which were terminated at the one year interim and two year necropsies. At necropsy, an examination was made of the external body surface and body orifices. The carcass was then opened and the contents of the abdomen, thorax and cranium were examined i-nsitu and following removal from the body. Organ weights (ie, wet tissue) were obtained at the interim termination from both the control and high-dose groups, and from the control and both FC-143 treated groups at the two year necropsy. The weights of the adrenal glands, brain, testes, heart, kidneys, liver, spleen and uterus were recorded for 15 randomly selected rats/sex/group. Body weights were obtained just prior to necropsy from the same rats in order to calculate organ weights relative to whole body weights. Representativesamples of the following tissues and organs from each rat were fixed in 10% neutral, bufferedformalin for subsequenthistologic processing: Aorta Adrenals (2) Brain (3 Sections including Liver (2 Sections) Lung (2 Sections) Lymph node (mesenteric) 7. frontal cortex and basal ganglia, parietalcortex and thalamus; cerebellum and pons) Eyes Gonads Ovaries (2) Testes/Epididymides(2) Heart Small Intestine(3 Sections) Large Intestine Kidneys (2 Sections) Mammary Gland (females) Pancreas Pituitary Salivary Gland Spinal Cord/Bone Marrow (vertebrae) Spleen Stomach Thyroid/Parathyroid/Trachea/Esophagus Urinary Bladder Uterus or Prostate Any tissue masses (suspected tumors) Any gross lesion Light microscopic examination was performed on hematoxylin and eosin stained, paraffin-embeddedtissue sections from all tissues listed above, when available,and from all rats in the control (Group 1) and high-d6se (Group 5) populations regardless of the cause of death. Microscopic examination of tissues from the low-dose (Group 6) rats included the tissues listed above except: aorta, brain, eyes, small and large intestines, lymph node(s), and spinal cord/bone marrow. The histopathologic examination and evaluation of these tissues was performed by Dr. Robert G. Geil, consultingVeterinary Pathologist (see Appendix Item D). BiostatisticalMethods: The means and standarddeviationsfor body weights, feed consumption, absolute organ weight, relative organ weight to whole body weight, organ weight to brain weight ratios and other laboratory data were determined separately for each sex and dose group. These data were analyzed using Bartlett's test for homogeneity of variance. If this test was not significantat alpha - 0.001, the data were further analyzed by comparing each treated group to the control group using a two-tailedDunnett'stest at the alpha - 0.05 significancelevel. The results of Dunnett's test have been indicated by asterisks on the mean tables. If Bartlett'stest was significantat alpha - 0.001, the data were ranked and a two-tailed Dunnett's test was performed on the ranks. These results have been indicatedby the pound sign (#) on the mean tables. 8. In addition,for each organ/lesionclassificationthe sexes were analyzed separatelyusing a two-tailedFisher'sExact Test comparing each treatedgroup to the controls. An alpha - 0.05 significancelevel with Bonferroni'sadjustment for multiple comparisonswas used within each organ/lesion/sexcategory. If the expectedvalue of each cell was greater than 20, then Yates' corrected Chi-Squaretest was used. An asterisk on the summarytables indicatesa significantdifferencebetweenthe controls and the treatedgroup. InternalRIKER memorandapertainingto these biostatisticalprocedures are presentedwithin Appendix Item E. 9. RESULTS In-Life Findinat: Body weight gains were depressed in excess of 10% in the FC-143 high-dose males compared to the control males through 66 weeks of the study. There was an approximate 21% decrease in the high-dose body weights by week 6. This differencewas statisticallysignificantfrom week 2 of the study until week 98 when the high-dose and control male body weights had gradually equalized. Likewise in the low-dose male group, a 5% decrease in body weights was observed at week 6, however, there was little additionaldecrease thereafter (Table 2, Figure I and Appendix F). The occurrence of a mild SOA virus outbreak at different times during the study may have had a slight influenceon the body weight data (see p. 12). Mean body weights were only very slightly decreased in the FC-143-treated females compared to the control female values through the first 18 months of the study. At 18 months, there was a gradual decrease in mean bady weights of high-dose females that reached a maximum of -11% at 92 weeks. The low-dose females also showed a decreased body weight, but the effect was not statisticallysignificantand the change was of a much lower magnitude (Table 3, Figure 2 and Appendix F). Mean feed consumption, presented as grams of diet consumed per day per kilogram of mean body weight, was increased in all of the FC-143-treated males throughout the study when compared to the male control feed consumption. This change was more pronounced in the high dose group where there was roughly a 13% Increase noted with sporadic values going as high as 29% during the two year test period. In the females the pattern was less consistent,but there was a trend toward lowered feed consumption in both FC-143-treatedgroups compared-to the female control values (Tables 4 and 5 and Figures 3 and 4). Overall, these variationswere related to the variation of body weight among groups. Actual mean feed consumption (without regard for body weight change) was slightly decreased in the high-dose males relative to control males, for the first year of the study. Feed consumption in low-dose males, while somewhat inconsistent,was slightly increased during this same period. 10. During the second year, the feed consumption of both FC-143-treatedmale groups was reasonably stable and consumption was comparable to that of the control group. All of the treated female groups tended to consume less feed than the comparable controls throughout the study. The greatest decreases occurred from 18 months to termination with the high- and low-dose groups being equally affected (Table 6 and 7 and Appendix F). The test article concentrationmeasured as parts per million in the diet was determined at 3 month intervals with a duplicate analysis performed when aberrant values were detected. The mean deviations from the target concentration of the high- and low-dose FC-143 groups were less than 3% (Table1). Actual test article consumptionwas determined for each 2 week period for each sex and each experimental group, and expressed as mg/kg/day. The mean test article consumption was estimated to be: males, 14.2 and 1.3 mg/kg/day; females 16.1 and 1.6 mg/kg/day for the high- and low-dose groups, respectively. Mean test article consumptionvalues calculatedat 2 week intervals for the entire study are presented in Table 8. Overall survival rates for the FC-143-treatedrats were good during the full two years of the test period. There were fewer deaths recorded in the high-dose males and females than in the comparable control populations. At the end of 1 year, 15 rats/sex from the control and high-dose groups were terminatedto fulfill the protocol requirementfor the interim sacrifice. The final survival rate then based on 50 rats/sex/groupat the end of 104 weeks was: males, 70%, 88% and 72%; and females, 50%, 58% and 48% for the control, high- and low-dose groups, respectively. The increased survival rate observed in the high-dose male rats compared to the control male rats, was statisticallysignificant(p :@ 0.05). Monthly mortality data are presented in Table 9. A summary of the most commonly seen clinical signs is contained in Table 10. The only clinical sign that occurred more frequently in the test article-treatedgroups was a dose-relatedincrease in ataxia reported for the FC-143- treated females. While the ataxia was most commonly associated with morbid animals and was seen in the control males and females, only the treated females showed an increase in the incidenceof this clinical sign; 2, 15 and 9 cases in the control, high- and low-dose groups, respectively. The incidencesof all other clinical signs in the FC-143-treatedgroups were generally less than or equal to the incidenceof the same signs in the control group. Rats administeredthe test article experienced a suspected outbreak of sialodacryoadenitis(SDA) viral infectionbetween the first and second months of the study. Clinical signs included swollen submandibular salivary glands and occasional ocular manifestations. The submandibular swelling was resolved within 10 days, and the incidence of ocular changes was extremely low. Similarly, the control animals had comparable symptoms during the sixteenth month of the study. Thirteen males and 13 females in the control group demonstratedsigns of this condition which lasted for about 16 days from the time of onset. One male and 3 females develooed ocular opacitiesduring this period. The incidence of palpable tissue masses in FC-143-treated groups was comparableto that of the control group. There were more animals with masses in the male controlsthan in the male treated groups; that is, 19, 10 and 7 animals in the control, high- and low-dose groups, respectively. Likewise, when the number of palpable masses which regressed or resolved before the termination of the experimentalperiod were evaluated, there were still fewer masses found in the FC-143-treatedanimals than in the control group (Table10). The results of the final ophthalmoscopicexaminations were negative relative to any FC-143 treatment-:relateedffects. Changes that were observed included a random distribution of cataracts believed to be normal geriatric changes of the lens and some cases of chronic uveitis and superficialkeratitiswhich were also consideredto be within normal limits for aging populationsof rats (Table 11 and Appendix G). Many of the rats found to have ocular lesions were identifiedas rats which were used to obtain blood samples via the retrobulbar venous plexus. 12. Red blood cell counts, hemoglobin and hematocrit values were minimally decreased in the high-dose male rats compared to control values, from 3 through 18 months. Statisticallysignificant(p - <0.05) decreaseswere seen at various times in the following parameters: erythrocytesat 6, 12 and 18 months; hemoglobin, 3 and 18 months; and hematocrit at 3, 12 and 18 months. While some of..theseparameters were also altered in the low-dose males, the changes were of a lesser magnitude and in some cases, were increased as well as decreased (Table 12). The female high-dose erythrocyte counts and hematocritswere slightly decreased at 3 months, but were slightly increased at 6 months compared to control values. At 12 months there was a statisticallysignificantdecrease in erythrocytecount, hemoglobin, and hematocrit (Table 13). Mean leucocyte counts were increased in both male treatment groups compared to control values, through the first year of the study. These changes were due to increases in absolute counts of lymphocytes at 3 and 6 months, knd in neutrophils at 12 months. Statisticallysignificant increases were observed: in lymphocyte counts at 3 months in the high- and low-dose groups, and at 6 and 18 months in the low-dose group; and in neutrophil counts at 12 months in both groups (Table 12). Similar changes were not seen in the FC-143-treatedfemales with the exception of a slight increase in neutrophilsand a slight decrease in lymphocytes seen in the low-dose group at 18 months (Table 13). Clinical chemistry findings at 3 months included slight increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (AP), as well as a moderate decrease in creatine phosphokinase (CPK) in both FC-143- treated male groups. From 6 until 18 months, the high- and low-dose male*ALT, AST and AP values were increased above the concurrent control values, whereas these values in the high-dose group were still elevated at 24 months. Albumin values remained very slightly elevated in the high-dosemales until the end of the study. Similar changes in clinical chemistry were not observed FC-143-treatedfemale groups (Tables 14 and 15). in the 13. Urinary findings included increases in incidence and severity of albumin and occult blood in all of the male and female control and FC-143-treated groups at 12, 18, and 24 months. These findings were more pronounced in the males than in the females at the terminationof the study. Other than an occasional incident of slight ketonuria in both control and FC-143-treated animals, there were no other remarkable urinary findings (Table16). Postmortem Findings: The Consulting Pathologist's complete report is located in Appendix D. The gross pathology findings seen at the I year interim sacrifice were unremarkablewith the possible exception of a single high-dose male having small testes and 3/15 high-dose females with mammary masses compared to an incidence of 1/15 in control female rats. Possible FC-143-relatedgross findings seen in male and female high-dose rats which were either found dead, euthanized j_qextremis, or euthanizedlat the terminationof the study, includedliver and testicularobservationsin the males and only a very slight increase in the incidence of mammary masses in the low-dose females. The liver findings seen in the males consisted of a slight increasein the incidence of liver masses, nodules and raised lesions,mottled livers and yellow or pale liver foci. While small testes were observed grossly in the control males as well as in both treated groups, testicular masses were found in 6/50 high-dose and 1/50 low-dose rats, but not in any of the controls. Mammary masses reported at necropsy in 1 high-dose and 2 low-dose males were found microscopicallyto be non-mammary lesions. Mammary masses were observed in 27/50, 26/50 and 37/50 of the control, high- and low-dose female rats, respectively. No remarkable FC-143-related liver changes were seen grossly in the female rats. Other gross pathologicfindings were typical of findings in aging rats of this strain (AppendixD). Organ weights presented as either absolute or relative (ratio of organ/body weight or organ/brainweight) values are contained in Tables 17 and 18. At the 1 year interim sacrifice where the only groups examined were the high-dose and controls (n = 15/sex/group),there was no change in male body weight (absolute)but a statisticallysignificant(p - <0.05) increasein 14. relativeliver and kidneyweights (vs. body weight)for the FC-143-treated males only. At the terminalnecropsy,slight increasesin relative(organ vs. body weight)liverweightswere noted for both the males and femalesof both dose groups, but the increaseswere not statisticallysignificant. Slight increasesin relativekidney_weightswere observed in both the male and female rats in the.high-dosegroup; however,only in the femaleswas this findingstatisticallsyignificant. Complete detailsof the histopathologicfindingsare contained in Appendix D and a summary of the major neoplasticand non-neoplasticmicroscopic changes found after 2 years of continuousoral administrationof FC-143 are listed in Tables 19 and 20. Histopathologicevaluationof the tissuesfrom the animals necropsiedat I year indicatedthe major FC-143 effectswere confined to the liver. Diffuse hepatomegalocytosis(12/15 animals),hepatocellularnecrosis (6@15 animals),and portal mononuclearcell infiltration(13/15 animals)were seen in the high-dosemales While incidencesin the control group were 0/15, 0/15 and 7/15, respectively.Testiculartubularatrophywith marked aspermatogenesiswas found in 2/15 high-dosemales but was absent in the control males. The only remarkablechange seen in the high-dose females was minimal to mild hepatocellularv-acuolation;the incidencefor this findingwas 11/15 at the high dose and 5/15 in the controlgroup. The majority of neoplasmsobserved after 2 years of dosing with FC-143, involvedeither the liver or one of severalendocrineor endocrine-related organs (Table 19). Hepatocellularcarcinomaswere found in 6%, 10%, and 2% of the males from the control,high-, and low-dosegroups, respectively. For the females,hepatocellularcarcinomaswere found only in the high-dose group with an incidence of 2%. The organ with the highest incidenceof tumors was the pituitarygland where the incidencesof adenomas in the males was 35%, 28% and 36%, and in the females at 71%, 71% and 83% for the control,high- and low-dosegroups,respectively. Mammary gland adenocarcinomaswere present in both control and treated females at an incidenceof 15%, 11% and 31% for the control,high- and 15. low-dose groups, respectively. In a similar comparison, fibroadenomaswere seen in 22%, 48% and 42% of the female rats at the end of the study. Mammary gland adenomas (7%) and carcinomas (2%), were seen only in the female controls, while one high-dose female had a lymphangiosarcoma. An increase in testicularLeydig cell adenomas was statisticallysignificant (p = <0.05) in the high-dosemales. The incidencefor this lesion was 0%, 14% and 4% in the control, high- and low-dose groups, respectively. There were minor variations in the tumor incidencepatterns in the adrenals (pheochromocytomas)and thyroids which represent deviations in two commonly occurring spontaneoustumors of this strain of rat. Only the incidenceof C-cell adenomas of the thyroid in male rats, appeared to show a slight dose dependent increase; namely, 0%, 9% and 4% for the control, high- and low-dose groups, respectively. However, C-cell carcinomas were seen only in the controls at an incidence of 5%. Non-neoplastic changes were found at the termination of the study in t%e adrenals,heart, liver, lung, pancreas, ovaries, salivary glands spleen, testes, thyroids and uterus (Table 20). As noted in the I yea'r interim histopathologicevaluation,the liver was the primary organ associatedwith FC-143 treatment-relatedeffects, and there was a remarkable consistency in the type of findingsobserved in the males after the second full year of test article administration. Megalocytosis, cystoid degeneration, and portal mononuclear cell infiltrationwere the major dose-related changes seen in both male and female test article-treatedgroups. Megalocytosis was found at an incidence of 0%, 80% and 12% in the males, and 0%, 16% and 2% in the females from the control, high- and low-dose groups, respectively. Hepatic cystoid degeneration, a condition characterizedby areas of multilocular microcysts in the liver parenchyma, was more commonly seen in male rats with a control incidence of 8%, whereas the high- and low-dose males had incidences of 56% and 14%, respectively. The incidence of this lesion in females was 2% in both of the FC-143-treatedgroups. Hepatocellular necrosis was equally distributed between the control and FC-143-treatedgroups. The incidenceof hyperplasticnodules, a localized proliferationof hepatic parenchymalcells, was slightly increasedin the high dose groups with an incidence of 6% in the males and 2% in the females as compared to 0% and 2% in the control males and females, respectively. 16. No hyperplastic nodules were found in the low-dose group. The incidences of other hepatic changes such as basophilic hepatocyte alteration and/or chronic inflammatory changes consisting of portal mononuclear cell infiltrationwere slightly increased in the high-dose males, but only against a high incidence of similarzhanges in the control group. Pulmonary changes that may be associated with the administration of FC-143 in the high-dose males, consisted of an increase in the incidence of alveolar macrophages (62%) and hemorrhage (44%) compared to control incidences of 20%. However, the incidence of chronic interstitial pneumonia and perivascularmononuclear infiltrationwas greatly reduced in the high-dose males when compared to the male controls. Pulmonary vascular mineralization was observed commonly in both control and test article-treatedmale and female rats; however, the FC-143-treatedfemales displayed an increase that was inversely related to the dose. The incidence of chronic sialadenitis,an inflammatory change of the salivary gland and often associated in rats with an antemortem viral infection, was increased in both the high- and low-dosemales. Hemosiderin, an iron rich pigment, was found in greater concentrations in the spleens of both high-dose males and females, but in greatly reduced amounts in the low-dose males and females as compared to controls. Two changes observed in the gonads of both sexes, appeared to be related to the administration of FC-143. Vascular mineralizationof the testes occurred in 18% of the high-dose males and 6% of the low-dose males, but was not seen in the controls. The incidenceof testicular tubular atrophy was only slightly increased in the high-dose (22%) and low-dose (207*)males compared to the control males (14%). In the test article-treated females, there was a dose-related, statisticallysignificantincrease in tubular hyperplasiaof the ovarian stroma. Tubular hyperplasia is considered to be a diffuse, non-neoplastic increase in stromal tubular elements which is usually bilateral and associatedwith decreased or absent follicular development. The incidence 17. of this change was 0%, 32% and 14% in the control, high- and low-dose groups, respectively. Cystic glands of the uterine endometrium were found at a higher incidence in the low-dose females (24%) when compared to the controls (14%) and high-dose females (10%). Other non-neo-plasticlesions (Table ZO) are commonly associated with either endemic diseases and/or geriatricchanges found in this strain of rat. The following changes were considered equivocal test article-relatedfindings or were usually decreased below the concurrent incidence in control rats. Adrenal changes are commonly seen in aging rats of this strain and the incidenceswere inconsistentlyeither higher or lower than the control values. The incidence of sinusoidal ectasia (dilatation)was increased very slightly only in the high-dose males (32%) compared to the control males (22%), while the control and FC-143-treatedfemales were almost equally affected (82 and 86%). The incidence of chronic myocarditis was reduced in an apparent dose-related fashion in the females while being increased above the control incidence in the high- and low-dose males. The incidenceof thyroid C-cell hy*perplasiawas slightly increased in the high dose females, while only the low-dose males showed a similar change. The incidence of acinar atrophy of the pancreas was very slightly increased in the treated males, while being slightly depressed below control values in the high-dose female. 18. DISCUSSION The purposes of this study was to define the long term toxicity and oncogenicity profile of FC-143, an anionic fluorochemicalsurfactant belonging to the chemical class of ammonium perfluoroalkyl carboxylates. The study was successfullycompleted with sufficient numbers of animals surviving in all of the experimentalgroups. The survival rates for the high-dose male and female rats were actually higher than those of the control rats after 24 months of the test. The general health of a rat exposed to the experimentalconditions of a 2 year feeding study may be examined at the beginning of the test by evaluating body weight gains and feed consumption compared to the study control animal population. Body weight gains of the FC-143-treated males decreased as early as the second week of the study, stabilized after 6 weeks, but remained slightly depressed in the high-dose males by at least 10% through 66 weeks. The treated females did not demonstrate any real decrease in body weight until'the 18th month, so there appeared to be a rather obvious sex difference in this parameter. The body weight changes did not appear to be associatedwith the palatabilityof the diet admix since feed consumed on a body weight basis was actually increased. Further, since there was a modest dose-relatedeffect seen in the male FC-143-treatedrats, it appears that these body weight changes could be associatedwith a direct test article effect. The concentrationof the test article in the diet was within a 3% range of the proposed levels of 300 and 30 ppm for the full 2 years of the study. The average daily dose of FC-143 for the same time period and for both sexes combined, was estimated to be 15 and 1.5 mg/kg/day. Both in-life and postmortem results confirmed the systemic absorption of the test article and the 300 ppm dosage level appeared to adequately comply with the concept of a maximum tolerateddose for a long term study in this strain of rat. The only clinical sign seen during the study which was associatedwith a test article effect was ataxia. The incidenceof ataxia was increasedin a dose related manner in the females, but not in the treated males. A 19. background incidence of this finding was seen in the male and female control population. During the early course of the study, a decrease in red blood cell parameters was observed in the high-dose males. While these hematologic values were often decreased below-the control male measurements at a statisticallysignificatn level (p :S0.05), generallythe decreased values were still within the acceptableranges for these parameters in the rat. The elevation of serum alkaline phosphatase, aspartate aminotransferaseand alanine aminotransferaseactivitiesonly in test article-treatedmale rats, suggested that FC-143 affected hepatocytes. These changes were seen from 3 to 18 months in both of the male FC-143-treatment groups, but only in the high-dose males at 24 months. These findings were substantiated by organ weight changes and histopathologyobserved at the I and 2 year sacrifices. Changes in the character of the urine specimens were similar in both control and treated rats examined during the course of the study. These findings were considered to be associated with the slowly developing degenerative changes of naturally occurring chronic renal disease commonly found in rats of this strain. The liver was the primary target organ affected as seen by an increase in relative organ weights, gross findings at necropsy, and histopathologic alterations. These changes seen at the I year necropsy showed remarkably little progressionI year later. The FC-143-treated males were more obviously affected than the females. The sex differences seen in this study were consistent with earlier pharmacokineticstudies using carbon-14 labeled ammonium perfluorooctanoate,-in which the females during 24 hours had excreted essentially 100% of an intravenousdose in the urine while the males excreted only 20%. Radioactive tissue residues were not detectable after 17 days in the females,while at 36 days, male rats had 2.8% of the carbon-14 in the liver, 1.1% in plasma, and lower but still detectable amounts in other organs.1 Similar results were reported by Hanhijarvi,et al.6 20. Hepatomegalocytosisand hepatocellular vacuolation are characteristic of increased metabolic activity in the rat. Following chronic hepatic stimulation, evidence of cystoid degeneration and, occasionally, hepatocellular necrosis may also be observed. Since the liver in the rat rarely repairs parenchymal cell loss with fibrosis or scar tissue, the most common finding is hepatocellularhyp'erplasia. In this study, the incidence of hyperplasticnodules was increasedvery slightly in the high-dose group, but the incidencewas not significantlydifferent from controls. It is also importantto note that no proliferativehepatic lesions (i.e. neither hyperplasianor neoplasia)were seen in any of the high-dose rats receiving FC-143 for 1 year. The observed hepatomegalocytosiswas similar to that reported by Pastoor et al in which perfluorooctanoicacid was administered orally to male rats at a higher dosage (50 mg/kg/day)2. It was proposed that the hepatocytic enlargement was due to proliferation of smooth, endoplasmic reticulum, mitochondria, and peroxisomes. The only hepatic neoplasms found in this study were hepatocellular carcinomas. The incidence of this tumor was 6%, 10% and 2% in the control, high- and low-dose male rats, respectively. Only one high-dose female was found to have this liver tumor. The incidenceof hepatocellularcarcinomas in high-dosemales was not significantlygreater than that of the control males and was comparable with the reported spontaneous incidence of this tumor.3 Based on these findings, FC-143 was not considered to be a hepatic carcinogen in the rat. The other neoplasms observed in this study originated from endocrine and/or endocrine sensitive organs; namely, the adrenal gland, mammary gland, pituitary gland, testes, and thyroid gland. The incidence for each of these tumors are presented in Table 19. The incidence of mammary gland adenocarcinomas was 15%, 11% and 31% for the control, high- and low-dose female groups, respectively. While mammary gland carcinomas and adenomas were found only in the controls, there was an increased incidence of fibroadenomas in the high-dose (48%, statistically significant: p :S0.05), and the low-dose (42%) compared to controls (22%). It should also be noted that 2/13 of the high-dose females necropsiedat I 21. year were found to have fibroadenomas,while 0/15 of the controls were similarly affected. Although the incidence of fibroadenomas in high-dose females was significantlygreater than that for the control females, the incidence was similar to that reported for untreated aging rats.4 In addition, when the incidences for benign mammary gland tumors (adenoma and fibroadenoma) are combined, the tumor incidence in the high-dose group is no longer statisticallysignificant. Leydig cell adenomas (i.e. benign tumors of the testicular interstitial tissue), were found at an incidenceof 0%, 14% and 4% in the control, highand low-dose groups, respectively. The high-dose incidence for this lesion was statisticallysignificant(p < 0.05) because the incidencein the control group was unusually low (0%). In addition, the spontaneous incidencereported for this neoplasm in this strain of rat was 7.4% for rats 24 to 29 months of age and was 14.6% at 30 to 38 months of age3 Based on another set of Sprague-Dawley two year study data compiled by Hazleton Laboratories,the spontaneous incidence of interstitialcell tumors was 28.7%.5 The remaining non-neoplastic findings reported from the histopathologic evaluation of all of the animals originally scheduled for the 2 year phase of the study were mostly geriatric lesions common to this strain of rat. The organs in which these lesions were found included: adrenal, heart, kidney, lung, testes, ovary, thyroid,urinary bladder and uterus. Specific deviations from control values seen in FC-143-treatedgroups were addressed in the results section of this report; however, the following changes may be considered incidentalor equivocaltest article-relatedeffects. The incidence of nodular hyperplasia of the adrenal cortex was increased (not statisticallysignificant)in the high-dosemales (18%) compared to the same finding in the controls (4%), while the high-dose females showed a much lower incidence (2%). Increases in the incidences of adrenal gland sinusoidalextasia (dilatation)were reported in the high- (32%) and low(26%) dose males compared to male controls (22%) while the incidences in 22. all test article-treatedfemales were equal to control values. It should be noted that adrenal lesions are commonly seen in old rats. Thyroid C-cell hyperplasia was seen in the control males and FC-143-treated groups with an incidence of 10% and 7% for the low-dose males and the high-dose females, respectively. The incidences were not dose-related or statisticallysignificant and were lower than the reported spontaneous incidenceof this lesion.3 Chronic myocarditis (inflammation)was seen at a slightly higher incidence in the low-dose (36%) and the high-dose (34%) males compared to the control (28%) group. The female incidence for this lesion was 32%, 20% and 10% in the control, high- and low-dosegroups, respectively. Inflammationof the heart is common in old rats. The lack of a true dose-relatedeffect in either sex suggests that this finding is probably not a treatmentrelated phenomenon. Chronic renal histopathologic'changes, commonly observed in aging rats, were not meaningfully altered by FC-143 treatment. None of these changes were apparently severe enough to produce pathologic lesions over a 2 year period. Therefore, none of these findings are considered to be directly related to treatment. Lung changes which were seen more commonly in FC-143-treated rats than in controls included an increase in alveolar macrophages, pulmonary hemorrhage (agonal) and vascular mineralization. The first two lesions were seen predominantly in the high-dose males where the incidences were statisticallysignificant(p :@0.05). Control males on the other hand, had higher incidences of interstitial pneumonia and pulmonary perivascu.1ar mononuclear cell infiltration. Pulmonary changes are common in aging 3 rats. Other than the possibilitythat an increase in the alveolar macrophages may be associated with FC-143 administration, all of the pulmonary changes were not considered related to test article treatment. Chronic sialadenitis or inflammation of the salivary glands was significantly(p < 0.05) increasedin the test article-treatedmales, but 23. not in the test article-treatefdemales. These changeswere attributed to outbreaksof sialodacryoadenitivsiral infectionswhich occurred in both the control and FC-143 animal rooms, but at differenttime periods and apparentlywith differentlevelsof intensity. The incidenceof splenic hemoside-rosisd,epositionsof iron-containing pigment in the sinusoidsof the spleen,was increasedabove control levels by approximately12% in only the high-dosemales. However, the incidence in high-dosemales was not significantlygreater than the control incidence. The incidenceof this lesion in FC-143 treated females was significantlylower than the incidenceof splenichemosiderosisin control females. A statisticallysignificant,dose-relatedincreasein the incidencesof ovarian (stromal)tubular hyperplasiawas found in low and high-dose groups. The interpretationof these changes in the absence of any observableprogressivepathologiclesion after 2 years of treatment,must be consideredas equivocallyrelated to FC-143treatment. 24. CONCLUSIONS The results obtained under the conditions of this study when FC-143 was administeredin the diet of male and female rats at concentrationsof 300 and 30 ppm for 2 years may be summarized as follows: I. FC-143-related changes were found more commonly in males than in females of each of the two treatment groups. This finding supports earlier pharmacokineticstudies that demonstrated a increased FC-143 retention by treated males compared to treated female rats. 2. The major dose-related findings were observed in the liver and consisted of megalocytosis and cystoid degeneration with only a minimal proliferativeresponse and related elevations of serum enzyme activities. 3. Other non-neoplasticfindings reported in this study were not consideredprimary test article-relatedeffects, but rather were related to spontaneous changes occurring in aging rats. 4. Based on the incidence, types of tumors, time of tumor appearance, malignancy patterns of tumors and survival rate after 2 years, FC-143 is not consideredto be carcinogenic in the rat. 25. PRINCIPALPERSONNELINVOLVEDWITH THE CONDUCTAND REPORTINGOF RIKER EXPERIMENTNO. 0281CROO12- TWO YEAR ORAL (DIET) TOXICITY/CARCINOGENICISTTYUDYOF FLUOROCHEMICALFC-143 IN RATS NAME S.I. Bistner, D.V.M. M.T. Case, D.V.M., Ph.D. R.G. Geil, D.V.M. R.W. Hawkinson, Ph.D. J.D. Henderson, D.V.M., M.S. M.K. Hopp, A.A.S. C.D. King, D.V.M., Ph.D. C.E. Ludemann, B.S., M.T. L.A. Marschke S.E. McCarville, B.S., M.S. W.C. McCormick, III, B.S. J.R. Nelson, H.T. G.C. Pecore S.L. Westmark, A.A.S. L.O. Wiseth POSITION/FUNCTION External Consultant/ Veterinary Ophthalmologist Manager, Safety Evaluation External Consultant/ Veterinary Pathologist Supervisor,StatisticalServices Manager, Laboratory Animal Medicine and Pathology Senior Laboratory Technician/ Study Assistant External Consultant/Draft Report Preparation Senior Medical Technologist/ Clinical Pathology Determinations Advanced Secretary/ Report Typing Advanced Biostatistician Toxicology Specialist/Sponsor Representative and Project Coordinator Histotechnologist/Microscope Slide Preparation Supervisor, Laboratory Animal Care Laboratory Technician Senior Laboratory Technician/ Assisted With Study Data 26. SIGNATURE PAGE TWO YEAR ORAL (DIET) TOXICITY/CARCINOGENICITY FLUOROCHENICAL FC-143 IN RATS RIKER Experime@nt No. 0281CROO12 STUDY OF From the Pathology and Toxicology Department RIKER Laboratories, Inc./3M Company St. Paul, Minnesota U.S.A. Study Director: "-@onard J. SWinski, B.A. Senior Toxicologist 8,/.v/,t7 "Date Report Reviewed By: Jamls L. Allen, Ph.D. Diplomate, A.B.T. Research Toxicologist ;Lt-F-7 Date Report Approved By: Edward E. Erickson, Ph.D. Laboratory Manager rr-7 Date 27. REFERENCES 1. Johnson, J.D. Extent and Route of Excretion and Tissue Distribution of Total Carbon-14 in Male and Female Rats After a Single IV Dose of FC-143- C. Riker Laboratories',Inc., St. Paul, MN 55101, Internal Drug Metabolism Report, 1-20, January 30, 1980. 2. Pastoor,T.P., Lee, K.P. and Gillies, P.J. Morphologicaland Biochemical Characteristicsof Perfluorooctanoate- Induced Liver Enlargement. The Toxicologist,5(l):155, March 1985. 3. Anver, M.R., Cohen, B.J., Lattuada, C.P. and Foster, S.J. Age-Associated Lesions in Barrier-Reared Male Sprague-Dawley Rats: A Comparison Between Hap: (SD) and Crl: COBS CD (SD) Stocks. Exper. Aging Res., 8(1)Part 1:3-24, Spring, 1982. 4. Prejean, J.D., Peckman, J.C., Casey, A.E., Griswold, D.P., Weisburger, E.K., and Weisbureger, J.H. Spontaneous Tumors in Sprague-Dawley Rats and Swiss Mice. Cancer Research L3:2768-2773, November, 1973. 5. Hazleton Laboratories,Vienna, VA. Historical Control Data, page 16, February 17, 1984. 6. Hanhijarvi, H., Ophaug, R.H. and Singer, L. The Sex-Related Difference in PerfluorooctanoateExcretion in the Rat. Proc. Soc. Expr. Biol. Med. 171:50-55, 1982. 28. Table 1 Two Year Oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon FC-143 in Rats Analytical Analysis of FC-14A Above/Below Desired Concentration) Approximate Study Month CCD Analytical Report Numbers 0 (Initial) 213 1 229 4 250 7 289 10 319 11 328 13 340 16 366 19 384 22 395 24 404 Dosage Levels (ppm) 300 30 + 0.6% + 0.3% + 5.0% + 1.2% b m34.0% - 6.1% m 2.3% + 2.6% + 2.0% + 3.0% + 9.4% - 1.0% + 1.0% 2.3% 0.0% 6.7% ---+ 7.7% + 4.4% + 2.2% + 3.3% +10.0% Mean Deviation for the Study + 1.6% + 1.9% Commercial Chemicals Division (CCD) Incorrect values given at this level due to instrument mlfunction: this dosage level was reanalyzed after now detector was installed. Excluding from mean deviation the percentages over + 20% acceptable limit. 29. Table 2 Two Year Oral (I)iet)Toxicity-Oncogenicity Study of Fluorocarbon FC-143 in Rats Summary of Mean Body Weights (g) + % Difference from Control MALES Study Week 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 so 52 Control Mean Wt. 300 ppm Mean Wt. % Diff. 165.3 270.9 334.0 390.7 429.2 456.2 475.5 493.2 502.9 515.3 526.8 542.3 550.4 561.0 567.5 576.3 580.6 582.9 591.0 599.4 608.4 612.9 619.8 623.5 626.1 639.2 638.6 162.1 234.3 276.7 308.6 353.2 380.1 398.0 412.8 425.4 436.0 447.4 456.1 464.2 475.0 484.9 497.2 505.7 511.8 514.2 524.8 535.2 540.9 550.8 552.0 558.5 566.7 570.1 - 1.9 -13.5 -17.2 -21.0 -17.7 -16.7 -16.3 -16.3 -15.4 -15.4 -15.1 -15.9 -15.7 -15.3 -14.6 -13.7 -12.9 -12.2 -13.0 .-12.4 -12.0 -11.7 -11.1 -11.5 -10.8 -11.3 -10.7 30 ppm Mean Wt. % Diff. 167.0 271.0 328.5 369.4 410.3 441.5 458.1 475.4 487.9 498.5 512.1 519.4 526.3 538.9 546.2 558.6 566.4 571.3 575.4 584.0 592.5 600.5 610.4 612.1 618.9 627.1 633.6 + 1.0 + 0.0 - 1.6 - 5.4 - 4.4 - 3.2 - 3.7 - 3.6 - 3.0 - 3.3 - 2.8 - 4.2 - 4.4 - 3.9 - 3.8 - 3.1 - 2.4 - 2.0 - 2.6 - 2.6 - 2.6 - 2.0 - 1.5 - 1.8 - 1.1 - 1.9 - 0.8 30. Table 2 (concluded) Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FC-143 in Rats Summary of Mean Body Weights (g) + % Difference from Control KALES Study Week 54 56 58 60 62 64 66 68 70 72 74 76 78 so 82 84 86 88 90 92 94 96 98 100 102 104 Control Mean Wt. 300 ppm Mean Wt. % Diff. 654.3 661.6 668.0 673.2 674.4 664.5 650.8 656.6 661.9 658.3 660.8 667.7 668.8 670.6 663.1 668.1 675.6 678.9 690.0 686.0 678.3 677.5 675.7 671.1 665.9 642.0 577.6 583.1 587.9 590.8 593.2 596.8 598.2 604.9 608.2 608.5 601.1 605.4 604.6 611.8 610.0 617.5 617.4 614.7 624.6 621.8 627.6 621.0 627.2 625.5 629.4 613.3 -11.7 -11.9 -12.0 -12.2 -12.0 -10.2 - 8.1 - 7.9 - 8.1 - 7.6 - 7.6 - 9.3 - 9.6 - 8.8 - 8.0 - 7.6 - 8.6 - 9.5 - 9.5 - 9.4 - 7.5 - 8.3 - 7.2 - 6.8 - 5.5 - 4.5 30 ppm Mean Wt. % Diff. 641.9 646.4 652.7 656.8 655.7 658.3 662.5 666.5 666.2 664.4 659.2 663.8 661.7 669.2 666.9 662.3 664.5 654.7 662.4 652.9 660.0 653.4 659.7 660.0 664.0 650.8 - 1.9 - 2.3 - 2.3 - 2.4 - 2.8 - 0.9 + 1.8 + 1.5 + 0.6 + 0.9 - 0.2 - 0.6 - 1.1 - 0.2 + 0.6 - 0.9 - 1.6 - 3.6 - 4.0 - 4.8 - 2.7 - 3.6 - 2.4 - 1.7 - 0.3 + 1.4 31. Table 3 Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FC-143 in Rats Stl--ry of Mean Body Weights (g) + % Difference from Control FEMA.LES Study Week 0 2 4 6 8 10 12 14 16 is 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Control 300 ppm Mean Wt. Mean Wt. 138.2 159.2 209.5 238.7 256.9 269.2 279.5 289.7 291.8 306.8 311.6 319.1 324.5 327.3 333.7 338.3 345.5 350.7 355.5 359.3 363.2 371.2 380.1 385.7 392.3 398.6 406.1 138.1 167.3 213.8 237.4 254.6 263.3 274.2 286.4 285.4 299.4 307.6 314.6 322.5 326.0 331.6 338.6 344.1 352.8 357.1 362.3 366.0 373.2 380.4 385.9 391.6 399.3 406.1 % Diff. + 0.0 + 5.1 + 2.1 - 0.5 - 0.9 - 2.2 - 1.9 - 1.1 - 2.2 - 2.4 - 1.3 - 1.4 - 0.6 - 0.4 - 0.6 + 0.1 - 0.4 + 0.6 + 0.5 + 0.8 + 0.8 + 0.5 + 0.1 + 0.0 - 0.2 + 0.2 + 0.0 30 ppm Mean Wt. % Diff. 137.2 166.0 214.9 235.7 253.8 261.3 275.5 282.8 285.9 298.0 304.1 309.9 318.6 323.6 330.4 339.0 344.9 353.5 358.0 363.1 367.5 375.9 382.0 389.7 395.8 399.7 406.2 - 0.7 + 4.3 + 2.6 - 1.3 - 1.2 - 2.9 - 1.4 - 2.4 - 2.0 - 2.9 - 2.4 - 2.9 - 1.8 - 1.1 - 1.0 + 0.2 - 0.2 + 0.8 + 0.7 + 1.1 + 1.2 + 1.3 + 0.5 + 1.0 + 0.9 + 0.3 + 0.0 32. Table 3 (concluded) Two Year oral (Diet) Toxicity-oncogenicity Study of Fluorocarbon FC-143 in Rats Summary of Mean Body Weights (g) + % Difference from Control FEMALES Study Week 54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 as 90 92 94 96 98 100 102 104 Control Mean Wt. 300 ppm Mean Wt. Diff. 414.1 419.1 420.9 423.6 426.6 426.1 424.9 427.5 431.4 435.2 446.5 455.2 464.8 474.9 484.0 484.8 492.7 499.1 500.6 512.5 505.7 506.9 500.0 501.2 503.6 502.0 411.5 421.2 426.4 427.0 431.9 434.0 435.5 433.0 429.1 432.8 444.6 447.4 452.7 457.0 461.8 457.6 458.2 456.6 451.8 455.9 451.0 464.5 468.0 464.2 462.8 450.3 0.6 + 0.5 + 1.3 + 0.8 + 1.2 + 1.9 + 2.5 + 1.3 - 0.5 - 0.6 - 0.4 - 1.7 - 2.6 - 3.8 - 4.6 - 5.6 - 7.0 - 8.5 - 9.7 -11.0 -10.8 - 8.4 - 6.4 - 7.4 - 8.1 -10.3 30 ppm Mean Wt. % Diff. 412.6 420.7 427.3 430.0 435.7 439.9 446.5 445.3 443.5 448.6 463.3 468.8 471.3 475.8 485.7 476.3 479.7 483.4 485.2 486.3 492.0 504.3 505.5 505.6 503.3 501.8 - 0.4 + 0.4 + 1.5 + 1.5 + 2.1 + 3.2 + 5.1 + 4.2 + 2.8 + 3.1 + 3.8 + 3.0 + 1.4 + 0.2 + 0.4 - 1.8 - 2.6 - 3.1 - 3.1 - 5.1 - 2.7 - 0.5 + 1.1 + 0.9 - 0.1 + 0.0 33. Table 4 Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FC-143 in Rats Summary of Mean Food Consumption Per Kilogram Body Weight (9 of diet consumed per day)--+ % Difference from Control MALES Study Week 1 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Control Mean Wt. 300 ppm Mean Wt. % Diff. 102.0 85.2 76.4 69.4 61.5 53.7 50.7 51.7 48.0 46.8 46.9 44.9 45.0 43.7 42.8 43.2 42.9 41.8 38.4 40.7 39.5 39.3 38.9 39.0 39.0 38.5 36.5 98.6 96.8 84.0 67.7 70.6 63.0 58.1 59.5 55.2 52.6 54.5 51.9 52.0 49.2 48.3 48.7 47.2 46.5 42.5 46.0 43.9 44.0 43.6 42.6 43.3 43.2 41.1- - 3.3 +13.6 +10.0 - 2.5 +14.8 +17.3 +14.6 +15.1 +15.0 +12.4 +16.2 +15.6 +15.6 +12.6 +12.9 +12.7 +10.0 +11.2 +10.7 +13.0 +11.1 +12.0 +12.1 + 9.2 +11.0 +12.2 +12.6 30 ppm Mean Wt. -% Diff. 103.8 85.0 77.0 61.2 64.1 57.4 51.3 53.5 49.3 47.7 48.9 47.3 46.3 44.9 44.5 43.7 44.0 42.8 39.7 42.2 41.8 41.3 40.5 39.7 38.9 39.4 36.1 + 1.8 - 0.2 + 0.8 -11.8 + 4.2 + 6.9 + 1.2 + 3.5 + 2.7 + 1.9 + 4.3 + 5.4 + 2.9 + 2.8 + 4.0 + 1.2 + 2.6 + 2.4 + 3.4 + 3.7 + 5.8 + 5.1 + 4.1 + 1.8 - 0.3 + 2.3 - 1.1 34. Table 4 (concluded) Two Year oral (Diet) Toxicity-oncogenicity Study of Fluorocarbon FC-143 in Rats Summary of Mean Food Consumption Per Kilogram Body Weight (g of diet consumed per day)_+ % Difference from Control MALES Study Week 54 56 sa 60 62 64 66 68 70 72 74 76 78 so 82 84 86 88 90 92 94 96 98 100 102 104 Control Mean Wt. 300 ppm Mean Wt. % Diff. 37.0 36.6 36.1 35.4 35.9 31.0 36.3 32.9 32.6 33.0 34.4 37.1 36.6 34.6 36.3 35.6 35.1 34.8 34.9 35.1 38.5 37.1 37.3 36.7 35.0 33.8 42.2 41.2 40.7 40.6 37.1 40.2 40.8 36.5 37.7 37.5 37.9 39.2 39.7 39.4 36.7 38.5 38.6 33.0 36.3 37.3 40.5 40.1 38.9 38.1 38.3 37.8 +14.1 +12.6 +12.7 +14.7 + 3.3 +29.7 +12.4 +10.9 +15.6 +13.6 +10.2 + 5.7 + 8.5 +13.9 + 1.1 + 8.2 +10.0 - 5.2 + 4.9 + 6.3 + 5.2 + 8.1 + 4.3 + 3.8 + 9.4 +11.8 30 ppm Mean Wt. % Diff. 36.3 37.9 37.5 37.3 37.1 34.5 36.4 33.5 33.0 34.9 36.7 36.9 34.9 36.8 37.6 34.3 35.4 33.0 34.7 35.1 36.8 37.5 37.4 37.3 37.2 37.5 - 1.9 + 3.6 + 3.9 + 5.4 + 3.3 +11.3 + 0.3 + 1.8 + 1.2 + 5.8 + 6.7 - 0.5 - 4.9 + 6.4 + 3.6 - 3.7 + 0.9 - 5.2 - 0.6 + 0.0 : 4.4 + 1.1 + 0.3 + 1.6 + 6.3 +11.0 35. Table 5 Two Year Oral (Diet) Toxicity-oncogenicityStudy of Fluorocarbon FC-143 in Rats Summary of Mean Food Consumption Per Kilogram Body Weight (g of diet consumed per day).+ % Difference from Control FEMALES Study Week 1 2 4 6 a 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Control 300 ppm Mean Wt. Mean Wt. % Diff. 98.8 107.0 97.2 81.0 74.1 72.6 70.2 64.2 57.2 64.3 63.4 58.6 59.5 57.0 61.7 59.7 58.4 52.9 56.7 56.8 58.4 54.2 54.7 48.5 49.2 51.4 48.3 96.6 101.6 81.8 81.1 74.9 72.5 70.4 62.0 56.3 62.9 61.5 61.2 58.0 56.2 58.1 57.4 56.1 51.4 54.2 52.7 51.6 53.6 51.8 50.8 50.3 45.1 48.3 - 2.2 - 5.1 -15.8 + 0.1 + 1.1 - 0.1 + 0.3 - 3.4 - 1.6 + 2.2 - 3.0 + 4.4 - 2.5 - 1.4 - 5.8 - 3.9 - 3.9 - 2.8 - 4.4 - 7.2 -11.6 - 1.1 - 5.3 + 4.7 + 2.2 -12.3 + 0.0 30 ppm Mean Wt. % Diff. 96.1 103.0 83.6 82.8 73.4 73.5 69.7 64.9 58.8 64.6 65.5 63.2 61.2 57.0 58.3 59.0 55.7 51.5 57.0 54.3 50.3 52.9 53.9 52.1 51.8 50.0 48.0 - 2.7 - 3.7 -14.0 + 2.2 - 0.9 + 1.2 - 0.7 + 1.1 + 2.8 + 0.5 + 3.3 + 7.9 + 2.9 + 0.0 - 5.5 - 1.2 - 4.6 - 2.7 + 0.5 - 4.4 -13.9 - 2.4 - 1.5 + 7.4 + 5.3 - 2.7 - 0.6 36. Table 5 (concluded) Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FC-143 in Rats Summary of Mean Food Conautoption Per Kilogram Body Weigh (g of diet consumed per day) + % Difference from Control FEMALES Study Week 54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 as 90 92 94 96 98 100 102 104 Control Mean Wt. 300 ppm Mean Wt. % Diff. 48.1 51.5 46.3 49.6 47.1 48.4 41.0 44.9 46.1 45.3 48.4 48.3 44.1 45.7 44.0 43.5 44.3 45.3 46.1 45.9 46.9 42.4 46.8 41.5 42.5 41.6 47.1 48.4 47.6 49.2 46.5 46.1 39.5 41.3 43.1 44.1 45.9 45.8 44.0 44.4 42.0 39.8 39.1 42.3 45.6 43.9 47.5 44.4 44.2 44.0 46.2 50.9 - 2.1 - 6.0 + 2.8 - 0.8 - 1.3 - 4.8 - 3.7 - 8.0 - 6.5 - 2.7 - 5.2 - 5.2 - 0.2 - 2.8 - 4.6 - 8.5 -11.7 - 6.6 - 1.1 - 4.4 + 1.3 + 4.7 - 5.6 + 6.0 + 8.7 +22.4 30 ppm Mean Wt. % Diff. 47.3 47.1 46.3 47.7 44.8 44.1 39.6 39.8 41.0 44.4 44.5 44.4 43.7 38.5 39.1 38.2 37.7 37.2 38.5 39.9 42.7 37.7 41.4 42.5 46.3 43.2 - 1.7 - 8.5 + 0.0 3.8 4.9 8.9 3.4 -11.4 -11.1 - 2.0 - 8.1 - 8.1 - 0.9 -15.8 -11.1 -12.2 -14.9 -21.8 -16.5 -13.1 - 9.0 -11.1 -11.5 + 2.4 + 8.9 + 3.9 37. Table 6 Two Year Oral (Diet) Toxicity-oncogenicity Study of Fluorocarbon FC-143 in Rats Sll--ry of Mean Food Consumption - Absolute (g/rat/day) + % Difference from Control MALES Study Week 1 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Control Mean Wt. 22.2 23.1 25.5 27.1 26.4 24.5 24.1 25.5 24.1 24.1 24.7 24.3 24.8 24.5 24.3 24.9 24.9 24.3 22.7 24.4 24.0 24.1 24.1 24.3 24.4 24.6 23.3 300 ppm Mean Wt. 18.7 22.7 23.2 20.9 24.9 24.0 23.1 24.6 23.5 22.9 24. 4 23.*7 24.1 23.4 23.4 24.2 23.9 23.8 21.9 24.1 23.5 23.8 24.0 23.5 24.2 24.5 23.4 % Diff. -15.8 - 1.7 - 9.0 -22.9 - 5.7 - 2.0 - 4.2 - 3.5 - 2.5 - 5.0 - 1.2 - 2.5 - 2.8 - 4.5 - 3.7 - 2.8 - 4.0 - 2.1 - 3.5 - 1.2 - 2.1 - 1.2 - 0.4 - 3.3 - 0.8 - 0.4 + 0.4 30 ppm Mean Wt. 22.9 23.0 25.3 22.6 26.3 25.4 23.5 25.4 24.1 23.8 25.1 24.6 24.4 24.2 24.3 24.4 24.9 24.5 22.8 24.7 24.8 24.8 24.7 24.3 24.1 24.7 22.9 % Diff. + 3.2 - 0.4 - 0.8 -16.6 - 0.4 + 3.7 - 2.5 - 0.4 + 0.0 - 1.2 + 1.6 + 1.2 - 1.6 - 1.2 + 0.0 - 2.0 + 0.0 + 0.8 + 0.4 + 1.2 + 3.3 + 2.9 + 2.5 + 0.0 ': 1.2 + 0.4 - 1.7 38. Study Week 54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 88 90 92 94 96 98 100 102 104 Table 6 Two Year Oral (Diot) Toxicity-oncogenicity Study of Fluorocarbon FC-143 in Rats Sll--ry of Mean Food Consumption - Absolute (g/rat/day) + % Difference from Control MALES Control Mean Wt. 24.2 24.2 24.1 23.8 24.2 20.6 23.6 21.6 21.6 21.7 22.7 24.8 24.5 23.2 24.1 23.8 23.7 23.6 24.1 24.1 26.1 25.1 25.2 24.6 23.3 21.7 300 ppm Mean Wt. 24.4 24.0 23.9 24.0 22.0 24.0 24.4 22.1 22.9 22.8 22.8 23.7 24.0 24.1 22.4 23.8 23.8 20.3 22.7 23.2 25.4 24.9 24.4 23.8 24.1 23.2 % Diff. + 0.8 - 0.8 - 0.8 + 0.8 - 9.1 +16.5 + 3.4 + 2.3 + 6.0 + 5.1 + 0.4 - 4.4 - 2.0 + 3.9 - 7.1 + 0.0 ; 0.4 -14.0 - 5.8 - 3.7 - 2.7 - 0.8 - 3.2 - 3.3 + 3.4 + 6.9 30 ppm Mean Wt. 23.3 24.5 24.5 24.5 24.3 22.7 24.1 22.3 22.0 23.2 24.2 24.5 23.1 24.6 25.1 22.7 23.5 21.6 23.0 22.9 24.3 24.5 24.7 24.6 24.7 24.4 % Diff. - 3.7 + 1.2 + 1.7 + 2.9 + 0.4 +10.2 + 2.1 + 3.2 + 1.9 + 6.9 + 6.6 - 1.2 - 5.7 + 6.0 + 4.2 - 4.6 - 0.8 - 8.5 - 4.6 - 5.0 - 6.9 - 2.4 - 2.0 + 0.0 "; 6.0 +12.4 39. Table 7 Two Year oral (Diet) Toxicity-oncogenicity Study of Fluorocarbon FC-143 in Rats Summary of Mean Food Consunption - Absolute (g/rat/day) + % Difference from Control FEMALES Study Week 1 2 4 6 8 10 12 14 16 Is 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Control Mean Wt. 13.5 17.0 20.4 19.3 19.0 19.5 19.6 18.6 16.7 19.7 19.8 18.7 19.3 18.7 20.6 20.2 20.2 18.5 20.2 20.4 21.2 20.1 20.8 18.7 19.3 20.5 19.6 300 ppm Mean Wt. 13.5 17.0 17.5 19.2 19.1 19.1 19.3 17.8 16.1 18.8 18.9 19.2 18.7 18.3 19.3 19.4 19.3 18.1 19.4 19.1 18.9 20.0 19.7 19.6 19.7 18.0 19.6 Diff. + 0.0 + 0.0 -14.2 - 0.5 + 0.5 - 2.1 - 1.5 - 4.3 - 3.6 - 4.6 - 4.6 + 2.7 - 3.1 - 2.1 - 6.3 - 4.0 - 4.5 - 2.2 - 4.0 - 6.4 -10.9 - 0.5 - 5.3 + 4.8 + 2.1 -12.2 + 0.0 30 ppm Mean Wt. 13.3 17.1 18.0 19.5 18.6 19.2 19.2 18.4 16.8 19.3 19.9 19.6 19.5 18.4 19.3 20.0 19.2 18.2 20.4 19.7 18.5 19.9 20.6 20.3 20.5 20.0 19.5 Diff. 1.5 + 0.6 -11.8 + 1.0 - 2.1 - 1.5 - 2.0 - 1.1 + 0.6 - 2.0 + 0.5 + 4.8 + 1.0 - 1.6 - 6.3 - 1.0 - 5.0 - 1.6 + 1.0 - 3.4 -12.7 - 1.0 - 1.0 + 8.6 + 6.2 - 2.4 - 0.5 40. Study Week 54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 88 90 92 94 96 98 100 102 104 Table 7 Two Year oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FC-143 in Rats Silinn-ryof Mean Food Consumption - Absolute (g/rat/day) + % Difference from Control FEMALES Control Mean Wt. 19.9 21.6 19.5 21.0 20.1 20.6 17.4 19.2 19.9 19.7 21.6 22.0 20.5 21.7 21.3 21.1 21.8 22.6 23.1 23.5 23.7 21.5 23.4 20.8 21.4 20.9 300 ppm Mean Wt. 19.4 20.4 20.3 21.0 20.1 20.0 17.2 17.9 18.5 19..l 20.4 20.5 19.9 20.3 19.4 18.2 17.9 19.3 20.6 20.0 21.4 20.6 20.7 20.4 21.4 22.9 % Diff. - 2.5 - 5.6 + 4.1 + 0.0 7; 0.() - 2.9 - 1.2 - 6.8 - 7.0 - 3.1 - 5.6 - 6.8 - 2.9 - 6.5 - 8.9 -1'3.7 -17.9 -14.6 -10.8 -14.9 - 9.7 - 4.2 -11.5 - 1.9 + 0.0 9.6 30 ppm Mean Wt. 19.5 19.8 19.8 20.5 19.5 19.4 17.7 17.7 18.2 19.9 20.6 20.8 20.6 18.3 19.0 18.2 18.1 18.0 18.7 19.4 21.0 19.0 20.9 21.5 23.3 21.7 % Diff. - 2.0 - 8.3 + 1.5 - 2.4 - 3.0 - 5.8 + 1.7 - 7.8 - 8.5 + 1.0 - 4.6 - 5.5 + 0.5 -15.7 -10.8 -13.7 -17.0 -20.4 -19.1 -17.5 -11.4 -11.6 -10.7 + 3.4 + 8.9 + 3.8 41. Study Week 1 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 TABLE 8 Estimated Mean FC-143 (mg/kg Body Weight) Consumption Per Day 300 ppm Male Female 29.6 29.0 25.2 20.3 21.2 18.9 17.5 17.9 16.6 15.8 16.4 15.6 15.6 14.8 14.5 14.6 14.2 13.9 12.8 13.8 13.2 13.2 13.1 12.8 13.0 13.0 12.3 29.0 30.5 24.5 24.3 22.5 21.8 21.1 18.6 16.9 18.9 18.4 18.3 17.4 16.9 17.4 17.2 16.8 15.4 16.3 15.8 15.5 16.1 15.5 15.2 15.1 13.5 14.5 30 ppm Male Female 3.1 2.9 2.6 3.1 2.3 2.5 1.8 2.5 1.9 2.2 1.7 2.2 1.5 2.1 1.6 2.0 1.5 1.8 1.4 1.9 1.5 2.0 1.4 1.9 1.4 1.8 1.4 1.7 1.3 1.8 1.3 1.8 1.3 1.7 1.3 1.6 1.2 1.7 1.3 1.6 1.3 1.5 1.2 1.6 1.2 1.6 1.2 1.6 1.2 1.5 1.2 1.5 1.1 1.4 42. Study Week 54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 88 90 92 94 96 98 100 102 104 TABLE 8 (Continued) Estimated Mean FC-143 (mg/kg Body Weight) Consumption Per Day 300 ppm Male Female 12.7 12.4 12.2 12.2 11.1 12.1 12.2 11.0 11.3 11.2 11.4 11.7 11.9 11.8 11.0 11.6 11.6 9.9 10.9 11.2 12.1 12.0 11.7 11.4 11.5 11.4 14.1 14.5 14.3 14.8 14.0 13.8 11.9 12.4 12.9 13.2 13.8 13.8 13.2 13.3 12.6 11.9 11.7 12.7 13.7 13.2 14.2 13.3 13.3 13.2 13.9 15.3 30 ppm Male Female 1.1 1.4 1.1 1.4 1.1 1.4 1.1 1.4 1.1 1.3 1.0 1.3 1.1 1.2 1.0 1.2 1.0 1.2 1.1 1.3 1.1 1.3 1.1 1.3 1.1 1.3 1.1 1.2 1.1 1.2 1.0 1.2 1.1 1.1 1.0 1.1 1.0 1.2 1.1 1.2 1.1 1.3 1.1 1.1 1.1 1.2 1.1 1.3 1.1 1.4 1.1 1.3 43. TABLE 9 nnsE_fLR.QUE TwO YEAR URALIUIET) TUXICITY-UNCO(iENI('Ify STUDY OF FLUOROCARBON "UHRALITY U&TA WEEK OF STUDY FC-143 IN RATS INITIAL I- 5- 4- 13- I?- 21- 2S- 29- 33- 37- 41- 4S- 4 f4ALES CONTROL 0 PPM HIGH DOSE 300 POM LOW DOSE 30 PPR4 so 0 0 0 0 0 0 0 0 1 a 0 0 so 0 0 0 0 1 0 1 0 0 0 0 0 so 0 0 0 0 0 0 0 0 0 1 0 ol FWALES CONTROL 0 PPM HIGH DOSE 300 PPm LOW DOSE 30 PP" so 0 0 0 0 0 0 1 0 0 1 0 0 so 0 0 0 0 9 0 0 0 0 0 0 0 so 0 0 0 0 9 0 0 0 0 0 1 1 MALES CONTQI)L 0 PPM HIC,H I)OSE 300 PP*4 LOW NOSE 30 PP-4 FEMALES CONTROL a PP04 HIGH DOSE 300 PJ04 LOW OOSE 30 PPm TABLE 9 T*O YEAR ORALII)IET) TOXIC[ TY-tiNCotjEimiCl ly SFUOY MURTALITY OATA OF I-LIJUHUCARFJON FC-143 IN RATS WEEK OF STUUY INITIAL @LoiL 51- 61- h5- 64- 73- r7- 81- oS- 09- 93- 97- 101- los--!!4- so 0 1 0 a 1 0 1 4 1 2 so 0 0 0 2 0 0 0 0 1 0 1 0 0 so 0 0 2 2 0 0 0 1 1 4 2 0 so 0 3 0 0 1 3 2 2 1 3 5 1 0 2 so I 1 0 0 1 2 1 3 1 4 2 3 0 50 0 0 0 1 1 0 s 1 6 ? I CHI-SQUARE TESTS FOR UuSt GROUP UIFFERTNCLJ FHU14 CONTROL MALES CmlSUIlAkt Pwo4. FEMALES C41- SQUARE PROR. 300 PPM 4.72 0.4)2?1 0.36 0.555 4@lb 111 PPM 11.09 O.-Ill 0.00 1.000 Significant difference from control at the St level Table 10 Two Year Oral (DL*t) Toxicity - OncogenLcLty Study of Fluorocarbon FC-143 In Rats Summary of Clinical Observations Initial number of rats Survivors at end of study Naos(en)!! (Mass[**] In various areas resolved prior to term) Alopecia In various areas c Swollen throatz- Palo (blanched) eyes and/or appears thin (emelated) Excessive lacrimtlon Ataxia Convulsions (clo.nLc) Occasional urinary Incontinence and/or h@turla Raised ulcerated lesion on hlnd foot ped(s) Occasional bloody nares Control a N F %@-- 65 65 100.0 34 25 45.4 19 38 (11) 7) 43.8 13.9) 6 14 13 10 15.4 15.4 9 9 13.9 8 12 4 2 3 0 15.4 4.6 2.3 5 4 6.9 7 0 5.4 3 1 3.0 300 ppo N p 65 65 100.0 44 29 56.2 10 40 8) 7) 38.5 11.5) 9 16 2 9 19.2 8.5 5 a 10.0 9 7 2 15 2 0 1 2 12.3 13.1 1.5 2.3 1 1 1.5 0 6 4.6 30 50 5 36 2 74 4) 61 4 91 6 5 4 3 5 0 a (Incidence In mien + Incidence In females) /total number of animals In the group x 100 b To be detailed In the pathology report Indication of SLalodacryoad*nLtLa (SDA) viral Infection Table 10 Two Year oral (DLet) Toxicity - OncogenLcLty Study of Fluorocarbon FC-143 in Rats Summary of Clinical Observations occasional bloody feces and/or diarrhea occasional episode of dympnea ListLng of the head Circular ulcerated area on skln Swollen (distended) abdomn Swelling in LnguLnal area Swollen log and/or foot Swollen ears Swollen penis PareaLs of hlnd log(s)/foot Control N F 2 0 1 0 1 0 4 3 0 2 I 1 3 0 0 0 0 - 1 0 300 Pkm- 30 N p N 2 1 1 1 0 0 0 5 1 1 0 2 0 0 0 0 0 2 1 1 0 1 0 0 - I 1 0 2 observations Phthisin BuIbL (Atrophy) Posterior Subcapoular Cateract(s) Corneal (ocular) Opacity (Diffused; ulcerated; focal with Iris staphylom; with pannue; partially collapsed). Chronic superficial Keratitin Table II Two Year Oral (Dist) Toxicity - Oncogenicity Study of Fluorocarbon FC-143 In Rats Summary of Clinical Ophthalmologic Findings sys(s) Right Left Right Left Bilateral Right Left Bilateral Control m 0 0 2 2 1 0 0 0 0 ppm p 1 1 0 1 0 2 2 1 300 ppa 3 3 0 0 1 0 1 0 0 0 0 0 0 0 0 0 30 ppm m 1 0 0 0 0 2 2 0 Right Bilateral 0 1 1 0 2 0 0 2 0 0 Note: Blood samples were taken via the retro-orbltal ophthalsologic abnormalities. venue plexus from almost all of the above an (M) Group males (1) Control (1)Control (1)Control (1)Control (1)High does (1)High doae (1)High dome (1)High dome Females (1) Control (1)control (1)Low dome Table II Two Year Oral (Diet) Toxicity - oneogenicity Study of Fluorocarbon FC-143 In Rata Summary of Clinical Ophthalmologic Findings Eye(s) Description of Abnormlity Right Right Bilateral Bilateral Right Bilateral Bilateral Left Chronic uvoitle (secondary to blood sampling) Diffused Ions opacity and chronic Lritin with microp Posterior Ions opacity Very pale choroidal circulation Dacryadenitia Chronic uvoitis with anterior synachia In right eye Diffused Ions opacity Focal, posterior, capoul Ions opacity Left Right Left Chronic uveltis with secondary exophthalmia Dacryadenitin Diffused I*na opacity with pannus and microphthalsia TABLE 12 TWO YEAR ORAL IDIET) MEAN TOXICITY-UNCOGENICITY ERYTHROCYTE VALUES STUDY OF FLUORUCARMON WITH STANDARU DEVIATIONS FC-143 IN RATS ERYTHROCYTES ICELLS X 10*06) HEM06LOSIN (G/DL) HEMATOCRIT (S PACmEn CELLS) mcv (MIGRONS*03) mcm (PICOGRAMS) N MEAN S.DEV. MEAN SADEV. MEAN S.DEV. MEAN S.DEV. MEAN S.DEV. MALE MONTH 3 0 pppq 300 PPM 30 PPM is 8.29 is 7.91 is ?.87 0.322 0*743 0.475 16.4 15.S* 16.1 0.39 0.50 0.67 4S.9 43.30 44.So 0.96 #*10 1.92 MONTH 6 0 PPM 300 PPM 30 PP04 IS 8o42 0.304 is 7.91* 0.350 15 7.580 0.306 15.1 14.5 14os 0.94 lool 0.83 44.S 43.1 43.9 2.?0 1.64 2.39 14ONTH 12 0 PPM 300 PPM 30 PPM 14 8.44 O.SS4 15 8.010 0.473 IS 8.38 0.354 IS.9 IS.? isos 1.1? 0.70 0.52 46.7 42.1* 44.S 3.69 1.98 1.88 MONTH 18 0 PPM 300 PPM 30 PP#* IS T.*R 2.0?1 15 ?.550 0.635 Is 8.6? I.iot. 15.1 14.BN 15.8 3.12 IdIs 1.52 40.0 40.6* 46.10 9014 9.00 4o4l MONTH 24 0 PPM 300 PPM 30 PPM e-n is 7.84 is ?.9? 14 7.9s 1.003 0.6?0 0.869 14.S 14.6 lob.7 1.59 1.42 1-23 4?.3 43.3 42.5 5.34 S.?2 4022 P is OS9 TWO TAILED P cu oDS9 TWO TAILED DUNNETY DUNNETT 7 ON RAW DATA. T UN RANKED DATA. 55 1.9 1908 o.eo Sb 4.3 19.7 I.SS S? 2.S 20.6 0.83 so 4.3 ss 3.0 see 1.9 17.9 1844 19060 1.41 1.34 oo?9 55 2.2 Sao 1.? 5A* 1.? 16.8 1969 1865 0.84 oos4 go?2 sa 6.2 21*0 3.09 S4 2.2 19#6 0.92 54 4.6 18.1#0 oo93 54 3.4 ss sot. 51# 2.0 18f.6 18.4 1865 1.27 1.10 0.91 TABLE 12 TWO YEAR URAL IT)IETI TOXICITY-ONCOOENICITY MEAN LEUKOCYTL VALUES STUDY OF FLUOROCARBON WITH STANDARD DEVIATIONS FC-143 IN LEUKOCYTES ICELLS X 10**3) NEUTROPHJLS ICELLS X 100*31 LYMPHOCYTES (CELLS X 10003) MIONOCYTES ICELLS x 100*31 Cos ICELL N MEAN S.DEV* MEAN SQDEV. MEAN S.DEV. MEAN S.DEV. MEAN MALE 14ONTH 3 0 PP#4 300 PPM 30 PPM is 12.73 2.074 is 14.93 2.801 ir, IS.22* 3.052 1.6S lash 2.14 0.656 6.936 00870 ID.?2 13.080 12.830 1.803 24?06 2:861 0.18 Ooll 0.17 0.196 0.102 0.173 0.17 0.16 Otil MONTH 6 0 PP14 300 PPM 3o PPm is Ili Is; lo.?4 12.72 14.46* 2.423 2-lbO 3.223 1.43 1.99 1*9? 6-727 0.909 1.146 0.85 10.06 11.81* 2.'416 2.316 2:918 0.29 0.38 0.33 0.160 O.IS4 0.?35 0 117 0:20 0.31 MONTH 12 0 PPM 300 PPM 30 PPM 14 ?.94 is 6.14 It; 10.3A* 1.572 1.7(19 1.747 1.10 2.260 29210 0.612 0.656 1.396 6.3S S.36 ?.Sto l.,2s6 11246 21.ISI 0.40 0.39 0.44 0.216 0.?47 0.233 0.10 0.14 0.18 MONTH 18 0 PPM 300 PPM 30 PPM is 11.41 is 9.91 is 11.16 7-325 1.4?9 S.157 5.06 2.78 2#550 6.402 1.657 3.353 5.61 6.30 8.200 1'.S04 1.1070 2'oS68 O.SO 0.69 0.390 0.40S 0.294 0.190 0.16 0.20 0.11 MONTH 24 0 PP#4 300 PPM 30 PPM c-n Is 10.79 ic; 9.09 14 10.44 ?.S29 2.351 3.464 3.72 2.41 3.24 5.666 1.4ftP 2.032 6.66 6.34 6.72 2.1140 1.1619 2.'I?l 0.34 0*26 0.39 0.398 0.1?6 0.292 0.08 0.08 0.0io I P 4= OSo TWO TAILED t P ga .059 TWO TAILED OUNNETT OUNNE7T T ON T ON RAW DATA. RANKEN DATA. TABLE 12 TWO YFAR ORAL ll)IET) TUXICITY-ONCOGENICITY STilOY OF FL(JONUCAHHON FC-143 IN MALE RATS INOIVIOUAL HFMUlikAM VALUTS --------------------------------------------------------MO-N-TH-=-3- ------------------------------------------ Dose PPIA 0 PPOO 0 PP" a PP" o ppm 0 ppoo 0 PPM 0 PPM 0 PPP a OPM a ppm o ppp a PP" a PPM 0 PP" 300 PP" 300 PPID 300 PPM 3oo PPs 300 ppo 300 PPP 300 PPt* 300 ppo 300 PPP 3oo PPm 300 PP" 300 PPP 300 PPM 300 PPM 300 PPM 30 PP#4 30 PPO 30 PPO 30 PPM 30 PPOP @30 pp" 30 PPM 30 ppm 30 PP#A Ln '40 PPM fl%) 30 PP" 311 PPM 30 PPO 30 PPOP 30 PPOO ANIMAL AIR3SIS AIR3S2? AIRIS32 AIR3S34 AIR353? AIR]540 AlR3S42 AIR3b48 AIR3SS2 AIR3SS9 AIR3S62 AIR3564 AIR3S6S AIR3S6? AIR3S69 BIR3SOS PIR3SOT 9lR3sR9 flIR3SY2 PIR3593 Rlp3s9s RIR3604 BIR360S AIR3610 AIR3611 RIA3617 OIR3623 PIR3&34 RIP1640 BIR3643 CIR36S4 CIP3655 CIR366S cipIf$67 CIP366ti CIR3673 CIR3fi?S CIR16?7 CIP36?9 CIR3683 CIR36RT CIR1690 CIR3691 CIRJfi92 CIR369S FRYTH polo ?07? 8.69 aois ?.?1 8.04 8.70 0.13 A.Po Fl.63 8.73 A.3? ao4l flo24 A.46 7.33 ?.A3 7.67 7.73 6.09 T.Rl ?.?? 7o64 7.99 A.77 7.?o 9.02 R.IS 8.17 9.44 7.10 ?.AS ?.77 T.Fka A.31 R.27 7.30 R.Sa 8.41 ?.A3 R.37 T.03 ?.9n 7.91 7.gi2 MEMO HIMAT 16.1 45 isos 44 l6oS 46 1663 45 16.3 4s it).? 46 thoo 47 lb.s 47 lb.to 46 16.4 46 isoto 4S 16*fb 47 16.3 46 16.8 47 16.6 47 42 16.0 44 IS*l 43 1'3.0 43 it#.? 41 is.5 43 14.fk 42 IS.4 43 Is.% 43 1!2.9 44 16.0 44 16.0 4% IS." 44 15.S 43 16.3 45 1506 43 Is.7 42 IS.A 43 16.S 4ti 17.0 46 16.0 44 ls.(l 42 ift.5 46 16.6 4b lb.r. 4h 17.6 4Y is.r. 43 45 lboo 44 1.3.6 43 mcv 55.SS56 %6.6281 52.y344 gis.2147 Sts.3658 ')7.2139 S4.0230 rs7.hlo6 S6.097t, b3.30?4 510"64 560IS29 S4.69614 S7.03HO 5S.12556 S?o29OF1 56.IV41 Sh.lifi2b SSib2?4 h7.3239i SjbOS7h b4.0541 s6o2M27 J3."173 '23.20*4 ST.1429 49.14"91 S3.YNTT se.h3lh 47.bh4s 6O.5b34 53*SO32 SS.3411 S7.1oh6 '*S.3550 !)3.2044 S?.t)342 ',3.6131 S4.hYhh '39.r4t14 SH.54i?4 hi.16t)4 li6.46,10 MCH MCHC 19.8lbs 19.94Hj 10.9d73 10.0()00 21.1414 20.7711 19.3103 2o.?*452 ?0.2439 19.Ooibl 17.8694 19.Fl12l 19.3817 20.3ri"3 ig.fiei? 20.4b311 20.43*2 19.64ill 19.4049 i!4.1374 19.8*b4 19.0476 20.1571 19.3-492 19.?2hl 20.7792 l7.73H4 19.3465 isi.911" IT.?bhy 21.911" 20.0000 20.3346 2o.qj9l 20.4573 19.3470 eo.%4?y 14.210" lg.?Jh4 21.0128 2l.n27S ?2.fl4H4 zo.onon 2n.?erh eU.7447 3r,,1776 3S.Zeli 3S.db46 36.2e22 36.2222 36.3U43 313.7447 3r%.1064 36.0070 35.bb?2 34.bb6l 3r)*Jlyl 3S.4348 3S.71#47 3ci.3191 36i.7143 36.3ft3b 35.1163 34."Rjl 35.0531 36.046S 39i.2301 3ri.8140 3hoD46S 36.1364 36.3b36 IS.SS@)6 35.9091 36.046S 36.2222 36.2741 37.3HIO 3h.7442 36.6bb? 3h.9bbS 3ho3636 39.7143 35.kbvb 36.0firo 35.6646 33.Ylh4 36.04bb 3r%.Illl 3h. 3t)36 36oe?41 wmc l2o6o 11.00 10.00 13.30 11.30 12.riO i2oto IS.50 14.00 ll.SO 11.90 12.t$O 9.Ss IS.50 17000 14.20 14.30 13.40 19.60 10.70 13.90 14.00 IS.20 21.70 17.90 14.40 13.%0 14.70 12.?0 14.30 16.40 10.40 12.70 14.70 11.5n 15.10 17.00 14.50 20.HO 17.?0 15.70 14.kO 21.30 13.40 12.iio PP4NAB 1.3860 1.6500 1.0000 lo3)OO 2.4h60 I.b?50 I.Joibo 2.6350 1.9600 1.03bo 2.2610 1.3860 0.7664 2.?900 O.RSOO 1.1360 1.?160 1.0720 2.lsfoo 0.5350 1.2SIO 0.4200 2.1280 3.689o i.qb9o 3.0240 1.3SOO O.Sono 0.7320 2.0020 2.29t*O 0.5200 2.IS90 2.3520 2.4150 2.Sb?U 3.4000 2.3200 2.i?"80 1.7200 0.9420 1.3320 3.40RO 3.2160 1.15?0 LYMAIJ looq6do 9.0200 0.9000 11.5710 io.,,626 12.0900 11.4600 10.1200 Y.4010 10.83bO 8.8136 12.SSSO lh.4700 13.0640 12.4410' 11.9260 17.2480 10.0560 12.3710 13*3000 12.9200 17.79*0 15.3940 11.0800 itobloo 13.9650 11934bO 11.7260 13.9400 908800 IO.S410 1107600 6.7400 12.3820 12.1500 12.0350 IN.5120 15.4600 14o6OlO 13.0240 l7.8y2o 9.6480 11.2640 TABLE 12 7*0 YEAR OWAL (f)IET) TOxICITY-ONCOOkNICITY STUDY OF FLUONOCAMHON FC-143 IN MALE HATS INDIVIDUAL HFF40(ikAM VALUES --------------------------------------------------------M(-J-NT-H-=-6 --------------------------------------- DOSE ANIMAL ERYTH ME040 HEMAT 0 PPM AIR3SI9 8.24 isoo 46 0 PPM AIR3524 oesi 14.4 42 0 PPM AlP3S29 8.23 14.6 44 0 PPM AIR3S33 6*30 itio7 4S a PPM AlP3S3? Rol3 IS.Y 47 0 PP" AlR3S41 8.42 ]S*9 46 0 PPM AIR3547 7.40 14.8 44 0 ppm AIP35SO 8*3R IS.4 4s 0 OPM AIR3SS3 R.3n IS.6 46 0 PPM AlP3SS? 8.9s 13*0 37 o PPIO AIR3SS9 9.03 16#2 47 0 PP" AlR3S6? A.Se 14.8 4S 0 PPM AIR]SB? 9.69 16*2 47 0 PPM AIR3S?3 R,70 isoo 4S 0 PPM AIR3S?S 9.44 13*5 41 300 PPM 6103583 R.16 14.8 43 300 PPM RlR3S$4 7.93 14.s 42 304 PPM OIR3596 7.63 11.7 43 304 PP$4 RIP3598 7.71 IS.1 43 300 PPM BIR3600 9.2? IS.6 44 300 PPM PlR3fio4 7.79 11.8 41 300 PPM AIR360e H.OR 14.8 43 3oo PPm RIP3609 8.00 IS.? 46 300 OPM 01IR3613 A.03 15.0 44 300 PPM BIR3617 7.01 15.1 4S 300 PPM RIP3428 A.3? 14.4 44 300 PPM RIR3629 8#07 14.2 43 300 PPt4 RIR3431 8.03 14.8 43 300 PP#4 RIP3633 7.42 13.3 39 3011 PP" FllR3h42 A*2() IS.2 44 30 PP" CIP3h46 ?.48 14.7 44 3n PPM CIP3650 7.79 14.8 #65 30 PPM CIR36S6 ?.?I IS.7 ffs 30 PP" ClR3NSO 7.60 15.3 42 34 PPM CIR3660 ?.SR 14.2 42 30 PPM ClR3fv64 ?.bol 14.R 43 30 PPM CIR3665 6.ys 14.0 41 30 PPM CIA366? 7.bs li.2 45 30 PP" CIP36?Y 7.vci 15.8 46 30 PP" CIP3680 7.31 14.0 41 cn !A3 30 PPM CIP36R2 7.99. 14.5 4s 30 PP" CIR3487 ? .96i 16.7 so 30 PPM CIPIS89 ?.OS 14.1 47 30 PPM CIR3#191 7.7? IS.? 4S 30 PPM CIP3694 7.44 13.6 47 mcv mcm MCHC SS.8252 44.3t)37 @3.4b2Y 54.2lb9 b7.8106 b4.6318 @4.4sys b3.6993 @ti.4217 41.340H !22.O4H7 S2.447b 134.0"52 til.7241 64.5782 '32.6961 tl?.Yt,34 56.3Sb-3 bs.7717 hi.20464 132.fo3lb 53.?I?ti !)?.Soou t)4.794h b4.1440 b?.0"4b t)1.2H30 bA.54ye t)e.sh(iti @23.btodS 5f.7h64 bb.3t)%o t)li.263? Sb.40y(l t)1.2b?o !3".VY2m !)0.8235 .3r.mbih Sh.o"?b f32.N931 !)9.5?4b 'ih.4sib Ifi.?n3y 16.9713 17.7411() 16.91by ly.SS72 IN.Rhib 20.0000 iii..'47ri 10.79@2 14.S?hl 17.94fi2 17.24V4 th.64.el' 17*2414 14.9Qn13 lh.)3f3 IN.?Ht)O 15.1342 19.SkJO lh.Rh34 17.7150 In.316ti 19.62!3,0 10.6AOO 2l.sfblo7 11.3117? II.C@gbo iii.431)Y 17.4?4S 16.c6lht. IY.h%e4 lm.qqhl 20.363t' 20.131h 1".7335 lg.?n?i 2fi.1439 ly.$46y3 19.M742 14.1111" IN.14?7 P I . 0 Or,3 210.f)Pll(l 14.614,41 1".?74h 32.60br 34.2b57 33.101A 34.8809 33.82Yu 34.Sbb2 33.(t3f)4 34.2222 33.9130 3b.1351 34.4bbI 32.8609 34.46HI 33.3333 32.9268 34.*Ihh 34.523H 27.?OVJ 35.1lb3 35.4b43 33.6585 36.41"h 34.1304 34.0909 33.Sl@-'ib 32.721) 33*0233 34.4lNb 34.loeb 34.S4b,% 33.4091 3?.EI"04 34.Shhy 36.4?Mh 31.00ys 34.4ldh 34.14h3 33.?77H 34.341" 34.14bi 3?.2k?2 33.4000 31.5-110# 31.771" 3?.3niO WHC 7.70 a.va 11.70 9046 9.14 Y.83 14.00 7.71 10.90 13.40 ".?0 10.70 llo30 11.30 16-30 13.40 11.70 12.10 4.74 15.30 12.fto 10.60 12.6o ll.go lo.so 12.70 IR.70 ll.SO 12.60 12.10 14.Hi) ir).30 16.90 9.01) 14.10 13.40 11.20 14.00 20.50 14.00 ly.on 9.11 13.)(o 17.lin Ili.oo PMNAO 1.3090 1.2ti7? I.OS30 I.S936 1.6452 0.9R3O 1.260D l.h962 3.5970 1.71#20 OOS?40 1.1770 0.3390 1.5820 1.6300 1.0?eo 1.1700 1.6SIO 3.603H l.9A9o 1.1520 3.2fibn 2.0160 4.0020 1.1)9so O.R"90 2.61go 0.9200 2.0160 1.4520 1.6?So 0.4li4o 4.?PSO 3.lh?S 2.9f)10 2.9460 1.7920 2.2400 1.6400 1.820n 3.2300 0.0911 0.78ho 1.0900 1.2000 LYMAH b.Ot]30 7.6330 10.4130 7.yboo 7.0378 8.3555 12.046D 5.6263 11-1220 7*OS20 noeeio 10.7350 9.0400 14.1810 10.7200 10.0620 10.5410 5.0440 13.IhOO 10.75?0 6.7840 10.?060 8.4180 800850 1101760 ili.33f#O 10.0050 9.7020 10.1640 12.2ft4o 12.54bO 11.9990 5.3395 10.7160 10.3180 M.7360 11.2000 17.0150 11.6200 lb.SROO 0.745b 12.OS?O IS.ISOO 13.2000 TABLE 12 TWO YLAN ONAL 40IFT) TOXICITY-ONCOGENICITY STUDY OF FLUOHOCAR"NN FC-143 IN MALE RATS INDIVIDUAL HEMOGRAM VALUES ---------------------------------------V -----------------MONTHal2 -----------0----------------w------------- DOSE ANIMAL ERYTH MEMO MEMAT mcv mch MCHC woc PMNAB LYMAO m 0 PPN 0 pp" 0 ppm 0 PP" 0 PP" a PPM 0 PP04 a PPM 0 PPM 0 PP$4 0 PP$4 a PP" o PP#4 0 ppp 0 PPM loo ppm 300 PP" 300 PPM 300 PPM 300 PPM 300 PP4 loo ppm 300 PPM 300 PPN 300 PP" 300 PPM 300 PPM 300 OPM 300 PP" 30A PP" 30 PPM 3f)PP" .40 PP04 30 PP30 PP" 30 PP" 30 PP" 30 PPM 30 PPM .40 pom 30 PP04 30 PPM 34 PP" 30 PP" 30 PPM AIN3516 AIR3SI? AIR3520 AIR3522 A103S27 AIR353S A143543 AIR3S46 AlH3SSO AlR3SSI AlR3SS4 AIN3568 AIR3S?O AlR3S?S A143SOO PIR3SO4 BIR3SoR 0103SO9 BIR3592 8143S98 0143604 RIM3613 BIR3blT RIR3620 61"3b22 0103626 "IR3b2? HIR3b3R 6lH3b42 8103643 CIR3649 CIR36so ClR3bS2 CIR36b3 CI"3b6g C193670 C103672 Clq3b76 C143679 C193680 ClR3bol ClR3##A3 C143haS CIA3691 CIR3694 8*33 8.07 8.49 8.47 8*84 8.47 8.9? 9.4? 9*12 8.48 7688 8.29 7*27 8.04 7.78 8.06 gels 6060 7*68 8.04 8.07 R.83 7.89 8*16 6913 8.01 8.12 8.30 8.38 80co? 8.69 8-29 a.d? 8.19 S.OS 8.00 9.02 a.s9 7.97 7*89 Bolo 0.76 0.33 8*41 lSo6 48 lbe? 46i IS.? 4S 16.4 4? IS.? 46 IS.6 4S 16.4 48 IR*l ss 16.4 si IS.8 47 IS.R 46 16.4 47 IP.S 30 IS.9 46 1500 42 15.6 44 14.9 41 13.4 38 14.8 41 14.7 44, 15.S 43 16.6 47 14*9 47 Is.6 43 IS.5 42 15.7 44 15.3 43 IS.? 44 15.3 43 16.2 46 IS.? 47 14.8 43 IS.6 47 Irv.? I#S 15.3 43 14*9 42 16.1 47 16.2 45 14.6 42 IS.3 42 16.1 4ci 15.3 46 IS.6 45 IS.1 43 57.6e3G SS.?621 53.0035 5S.4900 S2.0362 53.12A? 53.Slll 58.0781 SS.9211 SS.424S IR.72is 19.4S40 IR.4923 19.3625 1?.?602 18.41?9 IR.2832 19.1130 17.482S IA.b321 32.5090 34.0809 34*ad89 34*8936 34.1304 34.666? 34.1667 32#9091 32*1569 33abITO 7.9 10817 5.2 Oo624 6.6 0.816 9.2 0.?36 7.4 0.914 9.1 2.002 6.9 00828 8.2 0.328 so? 0*399 902 1.564 5.293 0 4*420 0 5.440 0 ?.?26 0 6*068 0 6.09? 0 S.796 0 7.298 0 S*073 0 ?.268 0 58:3?Sb 56.694d 52.2696 S?9?139 53.9b46 54.S906 bO.3067 S7.5?Ss 53.3854 b4oT264 53.2838 53.2276 53*2319 S2.6961 51.6bos 54.9313 5e.9557 S3*0120 51.3126 53.b7%6 54.OHS2 51.0697 S?.90?6 54.94SI S3.4161 5205000 SI.TOS2 S2.3065 52.69?h 53.2319 55.5556 S2.SI14 54.0216 51.1296 20:OSOB - 34:3*?8 8:0 I:S20 6:160 0 19.7024 34.8936 7.0 1.260 5.600 a 1?.1939 32.8947 909 0.49S O.Ril 0 19.17hi 34.S6b2 10.7 2.140 7.918 0 19.2802 3S*7143 ?.b 2.660 4.332 0 19.3S48 3594545 S.6 1.232 4.088 0 IS.?822 36*34is 6.8 1*836 4*148 0 ?0.3030 3S*2632 699 1.932 4.347 0 19.2708 36.OV76 8.1 ?.Sll S*184 0 10.2836 33-40VI S.S 2o36O S*610 0 19.2069 369046S 9.7 2.S22 6.402 0 lm.199S 3So3l9l 467 1.175 3*431 0 IO.d84T IQ.1176 35*4762 36.2791 8.2 2.214 9*3 3.069 S.412 0 50115 1 19.DbS2 3609046 9.1 2.639 6.097 0 19.6005 35.6818 9.3 3.162 5.487 0 to."424 3S.5814 6.7 1.206 S.293 0 IA.9is? 3506018 10.3 2.369 ?.622 0 JR.2574 3S.5814 11.3 2.938 70797 0 IR.9032 IS.2174 1105 2.IOS O.SIO 0 18.06h? 33*4043 7.7 2.233 4.466 0 17.oS26 34.4186 9.0 2.160 6.390 0 17.5874 33.1915 8.0 1.120 6.400 0 19.1647 34.8889 6.6 3.3S4 4.?30 0 19.OOb2 35.StII4 10.2 4.692 S.100 0 loofi2so 3S.4762 12.4 1.364 10.416 0. 17.?Ilo 113."!)Yl 34.2SS3 36.0000 13.9 12.2 4.170 I.SS6 8.096 0 9.802 0 IR.1187 34.7619 10.2 4.590 S.202 0 19.3916 3(1*4266 11.9 0.238 11.067 0. 19.0765 17.465d 35.77?R 33o260V 10.S 9.3 0.840 1.48R 9o4SO 0 ?.347 0. 18.7275 34.666? 10.4 2.184 7.176 0. 17.954H 35*1163 9.9 O.R91 8.316 0. TABLE 12 TwO YLAH ONAL (IIIET) TUXICITY-ONCOUENICITY STUDY OF FLUONOCAWSON @C-143 IN MALL HATS INDIVIDUAL HEMOGKA" VALUES --------------------------------------------------------MO-N-T-Hn-I-ft -------------------------------------- DOSE 0 PPM 0 PP4 0 PPM 0 PPM 0 PP04 o po#4 0 PP14 0 PPM 0 ppm 0 PPM 0 PP" 0 PPM a PPM 0 PP#4 0 PPM 300 PP" 300 PP04 300 PPM 300 ppiq 300 PPM 300 PP#4 300 PPM 300 PPM 300 PPM 300 PP04 300 PP$4 300 PPM 300 PPM 300 PPP 300 PP@ 30 PP04 30 PPM 30 PP" 30 PP" 30 PPM 30 PP" 30 PP04 30 PPM 30 PP#4 30 PP" 30 PPM 30 PP#4 30 PP04 30 PP#4 30 PPM AN114AL A103SI9 AlR3S21 A103S26 A103S31 AIR353A AiR3S39 A143S42 AlR3SS2 AIR3553 AIR3SSS AlP3S61 AIA3%hS AIRIS6? AIR3rl,74 &lN3S?? BIR3SM3 Rla3s93 14IR3596 HIP3600 BIR3601 BIR]60S 61IR36oA PIR3610 FIIW]612 HIP3615 *1143624 ElIR3632 PIR3641 HIR3644 PIR364% C103h4T CI"3651 CIA3654 CIP36SR Cla3662 C103663 CIA3664 CIA366? C103668 CIA3676 CIA3679 C103601 C19368S CIN36Rq CIR369S ERYTM 8.42 2048 8092 8.43 8.23 8.14 R.19 A.17 A.32 7.99 9.06 4.75 8.2S 3.59 A.64 6.04 si.Ag 7.p4 7.28 iltis 7.82 ?.?1 7.11 ?.gg $1.03 4.16 B.SS 7.48 A.31 7.36 6.20 Fl.70 8.19 A.qR 11.4a 9.?l 9.2h 7.9ci 8.79 A.90 9.90 T.fis A.74 A,37 R.02 MEMO IS.3 7.2 16.S lb.9 IS.9 16.4 16*6 16.0 16.9 IS.6 1706 12.3 16.4 15.9 lto*T 11.0 13.8 15.6 13.Y 14.6 16.0 14.2 IS.S 14.7 15.6 14.9 16.6 14.3 ls.s 14.6 11.7 16.3 15.6 lc;.g ll).l 16.1 16.S Ih.5 16.2 Ih.2 16.5 It..A IS.9 is.? 14.7 MT:IAAT 44 10 44 4#6 4S 43 47 44 4s 43 48 31 46 23 4s 33 3q 43 38 40 44 39 41 40 42 42 4!; 3Q 44 40 35 47 45 4? 53 47 1#0 54 47 46 4f, 41 4fi 46 44 mcv 52.2b6S 72.S806 49.32?4 54.5670 S4.b7Po S2.62sh 53.4699 S3.4556 54.ob6s b3.0173 52.9mol bS.2h32 sb.?S?h 64.iihh4 52.OP33 %4.635H 56.6b6o 54.R4h.4 %2.197" Sfi.737h 56.2660 5O.Sa37 %7.6b5'1 5?.7009 S2.31)39 51.4?Ob S2.b3lh 52.1390 52.Y403 S4.347M Sb.4sib S4.02311 S4.Y491 52.338% 46.1672 St.0315 SI.83%V 67.9?4.i b3.4694 5l.fthS4 bl.bds4 S3.5'4,LH' ')2. 6 3 1h S4.4lAp S%.Hb?h MCh JR.1710 ?9.0323 19.4918 Pe.0474 14.3lv6 PO.1474 19.1126 20.bb3o 20.1115 14.1747 14.4260 ?%.0947 ig.ArFia 24.7911 lq.3207 14.S36* 20.415041 1.4.ti4so 14.41431# 20.7092 ?0.4b04 IR.4176 ?1."Oo3 19.3676 14.4271 joi.2sqo 14.4142 14.1176 19."370 14.4710 IA.135h 19.114?6 17.10ho ih.tjfb ]?.4010 17.8imb 2o.1547 14.4300 lk.eo22 Im.t)JY3 1Q.3464 IM.11422 IR.1hol IA.3242 MCHC 34.77?7 40.0000 37.5000 36.1391 3S.3333 30.i3VS 3S.7447 3R.IftlO 37.SSS6 36.7442 3h.bb6t 39.6774 39i.6'32i? 30.b'OS7 37.1111 3%.7blh 393.3"*b 36.iTvl 36.b?09 31%.5000 36.3636 36.4103 37.8049 36.TSOO 37.1429 3S.4762 36.UtIHY 36.6667 35.2273 3h.40011 33.4,*bb 34.b"oy 14.hh67 33.0?qd 36.0377 34.ZSti3 34o3750 30.t)SSh 34.4tb#41 35.?174 3S.HhVb 16.OvTh 34.,3hb2 33.0435 33.4091 WHC 10.0 3'i.4 M.7 9.1 6.1 7.3 7.0 9.9 6.1 0.7 9.7 10.S 12.1 19.4 9.7 9.6 6.7 4.0 9. fi 9.8 9.3 11.4 9.5 13.6 9.2 10.5 11.2 9.3 lo.o 9.9 21.9 10.S 9.S 6.s ?I.S 9.3 0.7 7.6 6.7 16.1 12.S 14.5 14.6 7.1 6.4 PMNAS 4.400 26.196 4.176 1.72Y 1.769 3.139 2.418 2.5?4 2.211 1.218 3.9?7 4.775 3.872 12.028 1.4ss 1.440 2.680 2.070 1.440 2.35LA 1.209 S.700 1.005 7.206 2.116 1.360 30SO4 2.046 2.700 1.980 11.826 1.2hO o.s7o 1.560 7.955 1.9S3 0.609 0.608 0.402 5.'674 0.37!), 1.740 3.010 0.4?6 0.448 LYMATJ 4.600 7.otio 4.lr6 6.734 3.904 3.577 4.036 b.336 3.953 boybo 4.850 fi.723 8.107 6.790 1.469 7.584 4.020 6.300 7.408 b.b64 7.b33 4.78#1 6.935 4.896 5.900 5*9e5 6.496 b.85,4 6.700 7.227 9.14ti 8.115 b.740 14.680 12.900 6.9is 7.830 6.91b S.963 9*6tsO 11.750 12.IRO to.332 f).3 19 5.824 TABLE 12 To() YEAR UNAL (I)ILT) TOKICITY-ONCOUENICITY STUUY UF FLuONOCAkHON FC-143 IN MALL INDIVIUUAL HEMOOKA" VALUES HATS ------------------------------------------------------------- "ONYH=24 ---------------------------------------- BOSE ANIMAL ERYTH ME140 HEMAT mcv MCH MCHC Wfic PMNAB LYNAH 0 PP04 o opm A143SIM AIR3524 7.44 8.06 13.1 37 14.4 43 49.7312 53.2178 ii.bo75 17.0?lb 3S.4os4 33.4ga4 13.2 6.8 3.036 1.632 9.10d 4.760 0 PP$4 0 PP04 0 PPM 0 PP04 AIR3$28 kIP3531 AIR3S34 AIR3534 8*78 8033 ?.96 oos4 IS.5 4s 16.0 47 IS.3 46 Is.1 4S Si.7241 b6.422h 57.7h"4 h2.6y3i! 17.dlbl 19.?077 19.2211 17.ht$IS 34.444* 340042() 33.260'4 33.bSSk% 7.2 8.4 36.3 7.2 0.432 1.092 22.506 1.584 6o624 6.9?2 lie.342 5.2!)6 0 PP$4 AIR3S42 8.06 16.0 46 91.41AT la.US"7 34.7"26 7.1 o.lio 6.24i$ 0 PP" AlP3S48 8.09 IS*b 46 0 PP$4 AIR3SS4 6.00 11.0 34 0 PP14 AIR35ST 9.47 16.? so 46.Rh03 V)S.Vell S2.7903 19.2h3l 19.4079 17.634b 33.9130 34.1059 3394000 a.S 1.4b45 6.1iti@ 4.4 0.264 4.136 8.0 1.840 6.000 0 PP" AIR3S62 7.74 13.2 37 47.8036 17.IIS43 39isbIS7 IP.6 5.922 6.300 a ppm 0 PPM AlR3S64 AlR3S69 7.68 S.3p 14.f# 4? 12*0 33 S4.6b7s hl.3303 IR.7t)oo ??.304#1 34.i!"S? 36.3636 12.4 9.7 40712 0.77b b.820 8.1#24 o PP,4 AIR3S?3 O.S2 16.1 47 SS.1643 IA.0967 34.2%53 7.4 I.S54 b.32o 0 PPM AIR3578 6.70 12*1 37 giS.2k3V IR.4tiS2 34.3,?1#3 12.7 Ro2SS 4.191 300 PP" FliN3S@l 8.42 15.S 46 54.63110 19.4086 33.61457 602 0.968 4*960 300 PPM RIR3SMS ?.94 14.8 4.3 54.lb62 la."398 34.4186 lo.S ?*100 8.OBS 300 PP" FIIRIS91 7.9R Aboo 4e 300 PPM HIR3S94 8.17 14.4 43 6O.lbO4 52.6316 2n.ObOl ll.n245 33o333:1 33.4864 A.4 5*7 3.S?a 0.741 4.620 4084h 300 PPM 300 PPM 300 PP$4 AIR3S9? PIR3601 BIR360S 8.03 6-21 8.02 1503 12.0 IS.8 44 3ri S3 b4.794S S6.3boY 66.0040 19.0b,]S 19.3237 19.700? 34.7727 34.?MS? ?9.8113 8.7 9.6 6.3 2.697 4.608 1.197 5.bss 4.416 S*040 300 PP" 300 PPM 914360A BIR3611 8.21 0.04 13.b 39 IS*2 43 47.13030 53.4h?6 16.56&22 IR.9orts 34.h?18 3S.348" 9.8 11.0 1.062 I.S40 19742 8.910 300 PP" 300 ppm HIR3618 PIR3623 B.So 8.00 15.3 45 IS.6 52 S2.4476 65.0000 17."322 14.tpooo 34.0000 30.0000 8.2 9.s 1*722 1.80S 6*232 ?.I#lo 300 PP" 300 PPM 300 PP" HIP3630 FNIR3633 RIA3636 B.sg 6.Sl 8.1s 16.3 4" 11.6 33 13.ob 3FI SS."?89 SO.6412 46.62SH IA.Y76)6 IT.t$lH7 16.4417 33.4'283 35*ISIS 3$i.2632 7.S 14.2 12*6 I.OSO 4.S44 S.S44 6.300 9.511* 5.422 380 PP$4 fi]R]641 7.92 13.0 40 CIO.50%1 1?.4i@42 34.SGOD R.2 2*378 s.fb94 30 PP" CIR3646 30 PPM CIR36so 8:35 IS:O 4; 53:"422 1?:Yb4l 33:3333 9:3 S:ZO8 3:813 30 PP14 CIR3654 7.90 14.2 41 30 PP" C103#1519 8.96 16.0 47 Sl."9"7 S2.4Sg;4 lf.,4747 I 34.h341 .34.04ah 13.1 S.0 3.S3? 1.400 b.900 3.4so 30 PP" CI"3661 fj*34 15.2 44 52.157H IA,@12Lo4 34.54SS 8.7 2.349 5.829 30 PP" 30 PP04 CIR366? CIR3&70 7.34 7.21 15.2 43 13.7 39 tim.SH31 54.041S 2o.ro44 IY.41014 3cv. 3489 3'i.1282 7.4 12.8 1.776 4.09h S.2S4 ?.SON 30 PPi4 CIF#3672 0.81 15.4 1#6 51.0602 17.3614 33.47b3 14.7 7.644 6.460 30 PP" 30 PP" CI"3676 CIA3679 S.93 9.14 11.2 31 15.7 46 S2.276h 50.3202 IH.PIOTO 17.1772 36.12,40 34.1304 18.0 1?.S ti.120 2,375 IO.AOO 9.150 t-n 30 PP#4 CIR3687 0.37 15.1 44 52.5607, IR.0406 34.31"2 10.2 4.590 5.202 cn 30 PP" CI"3684 7.73 14.7 4? 54.33311' 14.016ti 3S.0000 9.S 1.900 7.410 34 PP" CI$136R9 8.14 IS.? 4r, SS.2"?h lh.hf32 33.1770 7.4 1.850 fb.vbo 30 PO" CIR3691 6.97 13.4 30 54.5144 14.2?S3 3rw.4eh32 10.4 1.976 ?.904 30 PPM CIP3694 B.o? 15.3 44 S4.8628 19.(1773 34o?727 7-2 0.576 6-552 TABLE 13 TWO YEAR ORAL IDIET) MEA4 TOXICITY-UNCOGENICITY ERYTHROCYTE VALUES SlfdDY OF FLUOROCARRON WITH STANDARD DEVIATIONS FC-1*3 IN RATS ERYTHROCYTES (CELLS X 10*061 HEMOGLOBIN 46/DLI HEMATOCRIT IS PACKED CELLS) mcv fMIORONS*03) PC" 4PICOGRAMS) 04EAN S*DEV* MEAN SGDEV. MEAN S-DEVE 14EAN S.DEVE MEAN S.DEVE FIENALE MONTH 3 8 PP44 300 PPM 30 PP" MONTH 6 0 PPM 300 PPM 30 PPM 14ONTH I? 0 PP" 300 PP" 30 PPM IS 6*91 0.319 15 6.67 0.266 15 7.260 0.505 15.6 IS.4 16.0 0.48 0.56 O.?o 43.1 42.00 43..9 1.11 I.SS 1.7s 15 7.3? 09413 IS 7.3? 0.327 is 6.920 0.4?5 ls.0 IS.4 13.70 0.5s 0.64 0.9s 42.3 4?OS 36.10 lo64 1.60 3.20 Is 7.60 0.300 15 6.920 1.193 is 7029 1*212 IS.6 14.60 15.1 0.40 1.74 1.?0 44.3 40.So 42.5 t.39 *.?3 4.76 6a 2.2 6a 2.3 61* 3.5 2249 23eO 22610 0.75 0*63 1.31 so 2.2 2006 0,95 so 2.2 21*0 0:93 S6 4.9 1909 1.93 56 2.1 201.6 O.?l 64 sel 21*S 3.19 so 6.8 Plot 2047 0 PP" 300 PPM 30 PPM MONTH 24 0 PP" 300 PPP 30 PP" IS 7.3? IS ?924 Is ?.Ol 0.668 0*809 0*763 15.4 14o,9 1*.o 1.43 1.33 1@32 1% 7.06 is 7.14 Is 7.06 10129 0.7'64 1.097 14.8 14.4 14.6 1.00 1.26 2.03 1 P 40 90%9 TWO TAILED I P 48 oOSe TWO TAILED NUNNETT OUNNITT T ON RAW DATA. T ON RANKED DATA. 42.9 41.9 41*S 4.13 9o86 3.65 42.3 60.4 41.1 5.40 3.66 9097 56 1.? 2140 0.66 so 2.6 ZOOT 0096 si 3.0 21#2 1.09 60 3.5 50* 2.1 59 2.S 21*2 20*3* 2067 1.45 0.?4 0.91 TABLE 13 TWO YEAR ORAL IDIET) TOXICITy-oNCOGENICITY MEAN LEUROCYTE VALUES STUDY OF FLUOROCARBON WITH STANDARD DEVIATIONS FC-143 IN R LEUKOCYTES ICELLS X 10003) NEUTROPHILS ICELLS X 100*31 LY"PHOCWTES ICELLS X 10-*31 MONOCYTES tCiLLS R 100*31 EOSI OCELLS N 04EAN SEDEV. MEAN SGDEV. 14EAN S*BEV. MEAN S.DEV. MEAN FEMALE MONTH 3 0 ppm 300 PPM 30 PPM is IR.96 is 16.51 is 16.06 2.690 3.778 3.4?0 2657 3o24 3.33 1.406 1.728 1.347 15073 14.?b 14.23 ZZ970 21834 3alOS 0.37 0*28 0.22 0.217 0.312 0.250 0.31 0.22 0.30 14ONTH b 0 ppm 300 PP14 3o PPN is 7.S2 2.SS9 Is 6.60 1.953 is 7.18 1*723 1044 1.55 1.76 1.586 O.TOS 1.023 5.61 6.?3 S.06 ?1160 1;764 1.1607 0.18 0.29 0.20 0.096 0.122 0.142 0.09 o.ii 0.15 "ONT" I? 0 PP04 300 PPM 30 PPN Is S.73 2.120 1.27 I.S62 is S.72 I.Ple 1.4s 1.261 Is S.83 1.13S lo34 0.6?9 4013 3.95 4.13 lo'049 l@061 0:792 11*21 0*2a 0.25 0.108 0.16S 0.098 0.12 0.99 0.10 MONTH 14 0 pp" 300 ppm 30 PP04 Is 5.75 2*230 is 6.30 2.368 is 6.83 2.608 1001 2.21 2ob9* 1.*31 1.950 2.240 4940 3.6LO 3.SIO O@973 11305 l@061 0.29 0*36 0.36 0.249 0.226 00148 0*63 0.100 0*07 MONT" 24 0 PP" 300 PP" 30 PPM Ul OD is 6.73 4.4b4 is 6#39 1.691 is 8057 3.434 2.8? 2015 3.44 2*9S9 6.962 2.9is 3.6? 4..04 4 el 1'329 1 1 190 1.641 0.1t 0.16 0.26 0.1si 0.06? 0.241 0.6? 0.06 0.08 I P ga .059 TWO TAILED I P ga OS9 TWO TAILED DUNNETT DUNNETT T ON T ON RAN VATA. RANKED DATA. TABLE 13 TWO YLAN ONAL 40JET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCANUON fC-143 IN FLMALE RATS INDIVIDUAL HEMOGRAM VALULS --------------------------------------------------------MO-N-TH-=-3- ------------------------------------------- oorte 0 ppm 0 PPM 0 PPM 0 PP14 0 PP" 0 PPM 0 ppm 0 PP" 0 PP" 0 ppm a PP" 0 PPM 0 PP$4 0 PP$4 0 PP4 300 PP#4 300 PP#4 300 PP$4 300 PP" 300 PP" 300 PP" 300 PP" 300 PP" 3oo PP$4 300 PP" 300 PP04 300 PPO 100 ppm 300 PP&4 300 PP" 30 PP" 30 ppm 30 PPM 30 PP14 30 PP04 30 PP" 30 PP$4 30 PP" 30 PP$4 30 PP14 30 PP" 30 PPM 30 PP" 30 PPI* 30 PPM ANIMAL N104S?6 NIA4s?@ NIR4SO2 M104S03 NIR4SR4 NIN4592 NIR4610 NIR4&12 NIN4613 NIR4619 NIR4621 NIR4626 MIR4627 NI"4633 NI"4640 OIR464S OIR4654 OIR4660 0104664 0104668 GIA4&69 0104672 01"4673 OIR4674 0144679 OIR4680 0144693 OIR4698 OIN4700 0104?01 PIR4?08 PIR4710 P104720 PIP4?21 PIR4?30 PIR4731 Plw4734 PIR473S Plq4736 P144737 PIR4738 PIR4?44 PIR4749 Plg*#Ts? PIR47S3 EPYTH 6.96 To?2 6*79 6.74 6*31 7.03 6094 6.14A 6.73 7-3S 6#60 6.94 6.A4 6.04 60qq b.Si OJ*77 6034 6.36 7.n2 6.99 6.3S 6.42 6.OA 6.72 6.46 6.RA 6.99 6.92 6.42 T.?9 6.9S 6.63 6.Ti ?.44 6o6O 6.41 7.66i T.Ri@ 7.12 7.40 7.14. ?.OS 8.30 7.39 MEMO 15.6 16*1 15.7 is.6 14*9 1602 IS.6 IS.? 15.0 16.5 15.5 16.0 16.4 16.0 lh*4 15.3 16*2 14.6 14.n 15.6 15.S 14.8 14.8 16.1 14.7 ici.4 15.2 15.9 1601 IS.1 16.7 IS.5 IS.? IS*? 16*4 1509 16.0 15.8 17.1 16.6 IS.8 15.8 14.9 17.0 14.6 MLOAT 43 44 43 43 42 45 44 44 42 4S 42 44 4% 44 4s 42 4s 40 40 43 42 40 40 44 39 42 42 44 44 43 4s 4.1 43 44 4s 44 43 43 47 4s 44 44 41 47 41 mcv 61.6046 bb.9948 63.3204 63.7go2 66.SbIO 64.0114 h3.4006 63.953S 62.40?1 61.2245 63.6364 63.0372 6S.7695 b4.3ZTS 64.3777 6405161 b6.4697 63.091S 62.8'jt3l 61.2536 60.0850 62.9921 ha.3053 63.953S S0.03S7 fis.olss 61.0465 62.9471 63.bo3g 66.9702 SI.7664 61.870S b2.957S 65.5730 60.4o39 64.?USV 67.0827 Sb.2092 59.6447 63*2022 N9.4.j99 bi.b24b. 50.1560 56.626S 5S.4004 mcm 22.3496 20."b4v 23.1222 23*1454 23.bl33 23.0441 22*4784 22.8196 22.2083 22*4440 ?3.4848 22.9226 23.4766 23.391U' 23.4621 23.!)023 23.9291 23.0204 23.2704 22.SOII 22.1745 23.3071 23.0530 23.4012 21*8750 23.8390 27.0930 22.1466 ?3.16S4 23.!)?02 21.4377 22.3022 2?.9060 23.3979 22.0430 23.3824 24.YbIO 20.6S36 21.100S 23.3146 21.3514 22.12m9 21.1348 20.4019 19.7564 MCHC 36*2791 36*5999 36.5116 36*2791 3S*4762 36*0000 3So4b4S 3So68l8 3S*7143 36.6667 36.9046 36.3636 36.4444 36*3636 36.4444 36.4266 3690000 36.SOGO 3?.0040 3fi.7442 36.9048 3700060 37.0000 36.S9$9 37.69@03 36o6667 36.199S 36.1364 36.5909 3S.1163 37.1111 36.046S 36*5116 35.bSI8 36.4444 36*1364 37.2093 36.?442 36.3030 36.bSB9 3S.9091 3S.9091 36.3415 36*1702 35.6096 woc 17.S 20.1 17.0 19.4 20.5 17.3 IS.4 21.0 16.1 21.0 24.3 21.1 19.6 20.4 14.0 12.4 16.7 19.2 18.3 18.6 IS*3 17.8 26.4 16*3 18.0 23.7 18.3 21*6 16.9 16.1 IS.3 20.4 IS.5 22.0 16.6 18.1 13.2 26.R 19.4 20.6 16.0 IN.0 17.3 17.9 13.8 PMNAS 1.92S 3*417 2.040 2.134 4*?IS S.882 2.IS6 2.310 2.698 0.630 1*944 4.009 1.1?6 2.040 1.?60 1.860 2.171 10?26 60?71 2.046 1.224 3.204 6*532 2.282 2.340 4.9?? 3.660 3.4S6 2.028 4.347 2.446 2.040 2.170 4.400 1.992 3.0?? 1.320 3.TS2 3.880 3.708 4.960 S.220 3.287 5.720 1.932 LYMAH 0 14*525 0 16.080 0 140280 1?.072 14.SSS 11.072 12.782 16.1#80 0 12.397 ( 19.320 0 21*384 0 16*4SO 0 19-032 IT*S44 12.040 lOol6@ 14.028 17.088 4 llol63 1 lSo624 0 13.923 0 13.TO6 0 21.016 0 13*BSS 0 159480 4 17-301 1 149091 18.144 14.703 11.431 12.546 l8olS6 12.710 lbo940 14.110 14.842 11.616 21.9?6 IS.326 16.068 0 10-720 11.700 0 14.013 10.919 0 11.868 0 TABLE 13 TwO YLAR ONAL 4DIET) TOXICITY-ONCOOENICITY STUDY OF FLUOROCAROON FC-143 IN FLMALE MATS INDIVIDUAL HEMOORAM VALUES --------------------------------------------------------MO-N-TH-=-6- ------------------------------------------- 00SE ANIMAL 0 PP" MIR4sR2 0 ppm 0 ppm NlR4s84 NIR4546 0 pp" Niw4s9o 0 ppp NlR4s9R a ppm NIR4603 a PPOO NIA4607 0 ppp NIR4616 0 PPP NIR4619 0 ppp 0 ppo MIR4621 NIR4622 0 PPOO 0 ppo MIR4629 MIR4631 0 ppv NIP4632 0 ppm NIR4639 380 ppo OIR46SO 300 ppm OIR4653 300 PPM 01046ST 300 PPO 300 PPO OIR*660 OIR4663 300 PPM OIR46?o 300 ppo 300 PPM OIR4673 OIR4681 300 PPM OIR4682 300 ppm OIR4&92 300 PPP OIR4693 300 PPP 340 PPM 300 PP" OIR4694 OIR4698 OIR4699 300 PPM OIR4700 30 PPid 30 ppm PIR4?10 PIR4?11 3ft PPM PIR4717 30 PPP PIR4?19 30 PPM PIR4729 30 PPP 30 PPP PIR473i PIR4?3? 30 PPM P144733 30 ppm PIR4?37 30 PPO PIR4?40 3()ppli PIR4?43 C) 30 ppo PIR474S 30 PPOP PI"4746 30 PPP 30 ppp PIR4?49 PIR47so ERYTH 7e32 ?.AS 6.41 7.19 7.31 fl.60 7.84 8.03 7.?n 6.oo 7.23 7.32 7036 7.28 7.05 6091 7.41 7.12 7.49 7.72 T.38 6.71 toes? 7.44 7.75 7.65 ?.64 7.07 ?.S#i ?.s3 fo.66 fi.95 fi.9fl 7.03 ?.Do 6.7$1 ft.3S 7.30 S.9ci 7.0? 6.80 7.19 7-12 A.13 6.71 MEMO 15.0 15.8 13*6 15.3 IS.1 14.? IS.8 14.6 15o3 14*3 14.4 IS-1 14.8 I!i.1 15.4 .1501 16.6 ISOI IS.3 15.0 16.0 14.6 14.8 IS.6 IS.0 15.0 lb.S 14.9 15.5 16.2 II.R 12.2 13.2 14.ft 12.4 12.8 15.0 If#.? 14.1 12.6 13.0 14.8 14.1 14.1 ii.t. "INAT 43 46 39 43 42 40 44 44 44 42 41 42 40 42 43 42 43 41 43 42 43 40 41 44 42 42 4s 41 43 4b 39 35 31 43 3S 36 41 42 35 35 36 43 40 41 02 mcv 5867432 bme!)907 5762fid? 59.HOS3 57.455S 606bobI SSoR3?6 546794S 5?*1429 6167647 56*7082 S7037?0 54.3478 57.6923 60.9929 60078is ST.Sbj6 56.0109 SY.4099 S4*4041 bH4265b 59*612S SY.6798 59.1398 b4.1935 %4o902O 50*900S 5769915 S6.d7h3 61,0890 ba.ssbb 5ldu449 53*0006 bl&1664 bo.Douo b3.0973 64.5669 S?.534? so*"235 49.13srs S2.9412 S9.hd"6 '16.1790 J0.4305 62.b931 MCh 20.4910 20.1274 20.2b43 21.2796 20.6566 22.2127 20.0too 18.1818 19.8101 21.0294 19.9170 2o.6284 20.14)87 20*7418 21.8440 21.8524 22.2222 ZO.6284 20.4272 19.4301 21.6802 21.7"6 2l.s429 21.2366 19.3S44 19.6078 2loSY69 21.07so 20.S026 21.S139 20.7207 17.0102 18.9112 ?I.OS26 11.7143 In.elyl 23.6120 2o.137o 23.6975 17.94h7 19.117h ?O.hl2tk ig.RO34 l7.ci892 20.2b83 MCHC 34.803? 34.34?8 3S.3846 35.SH14 3S,9b24 36.7Soo 3S.9091 33.1018 34.7727 34.0476 3SO1226 3S*9524 37.0000 3S.9524 35.8146 3S,9S24 3Ro6O47 36.82V3 3%.SH14 3S.7143 3?.2093 36.SOOO 36.OV76 3S.9091 3SO7143 3S.7143 36.6bb? 36.341S 36.046S 35.2174 3S.3046 34.0671 35.6757 34.4106 3S.4286 3S.SS56 36.SKS4 3S.0000 40.2dS? 36.0000 36.1111 34.4146 3ci.?Soo 34.8786 32.3Hlo wgc 8.59 b.4S 6.24 7.9s 7.43 ?.bg 6.43 6o9S S.98 6.61 4.s9 14.90 11.00 4.?6 ?.?a 7.98 6.So 12.70 11.30 7.66 a.?? 9173 9.So 9.18 7,29 9.41 9.99 6.SS 6.39 S.SS 10.AO S.6s 8.13 6.99 5.16 7.23 9.28 5.49 6.83 4.06 8.Hl 6.64 7.07 8.14 7.48 PMNAB 0.6872 o.Sibo 1.9344 1.192S 0.9b59 0.4614 O.S?87 0.4170 O.S382 1.2SS9 0.4131 4.?680 1.2100 1.0948 S*6OS6 2.1546 2*3120 2-9210 1.4690 1.80?8 1*4032 I.SS68 O.SSSO 0.5508 2.3328 2.1643 1.09"9 1.0480 0.6946 0.721S 1.6200 1.8080 3.4146 2.02?1 1.3932 1.3014 1.0208 0.6S88 1.2977 O.S2?6 4.3169 2.GS84 0.?777 1.?094 2.3936 LYMAS 0 7.5592 5.8695 4.0560 0 6.5190 1 6.315S 7.0748 507227 6.3940 5#322a 5.2219 400392 9o8340 9*2400 3oS224 1.3832 5.7'*Sb 4.1480 9.2710 0 9o6OSO 0 508950 0 7.1914 0 7.4921 0 S.?6SO 0 8.3S38 0 4.?38S 0 6.7752 0 8o3916 0 S.2400 0 S.3031 0 4.SSIO 0 8.9640 0 3.SO30 0 4.2276 0 4*6134 0 3.1476 5*3502 ?.?024 4.7214 0 4.9859 0 3.3292 0 4.0526 0 4.3160 0 S.8681 0 6.2678 0 4.7872 0 TABLE 13 TWO YEAR ORAL 4DIET) TOXICITY-ONCOGENIOITY STUDY OF FLUOROCAROON FC-143 IN FEMALE MATS INOIVIDUAL HFMOGRAM VALUES ------------------------------------------------------------MONT"ml2 ------------------------------------------- DOSE ANIMAL 0 PP" MIR4576 0 PP14 NIR4582 0 PPM NIR458S 0 PP" MIR4SOO 0 PPM MIR4SO9 0 PP" NIP4590 0 PPM 0 PP" NIR4601 NI"4606 0 ppo 0 PP14 NIR4610 HIR4620 0 PPM 0 PPM HIR4629 HIR4630 0 OPM 0 PPM NIR*631 HIP4632 0 PPM NIA4640 300 PPM OIN4642 300 PPM OIR46S2 340 PPM 300 PPM OIR46ss OIR46S6 300 PP" OIR4b64 300 PPM OIR4666 300 ppm 300 PPM OIR4h69 Olk467l 340 PPO OIR4674 300 PPO OIN4676 300 PPM OIR4687 3qo ppo OIR4699 304 PPM OIR4692 300 PPO OIR4699 300 OPM 30 PPM OIR4?04 PIR4?11 30 PP" 311 pp" PIR4714 PIR4?15 30 PP" PIR4?16 30 PPM 30 PPS4 PIR&II? PIR47el 30 PPM PIR47?S 30 PPM P1047P? 30 PP" PIR4729 30 PP04 PI"4734 cn 30 PPM PIW4?42 30 PP04 PIR4?43 30 PP" P104749 30 PP,4 PIR4?ctG 30 PPM PIR47ss ERYTH 7IS5 ?*S? ?.64 ?.23 ?.94 7.44 7017 8026 ?.32 ?.go 7.84 ?.44 7.68 7.5s 7.30 7.22 7*31 6.96 7.81 7.11 6090 7.16 ft.9s 7.92 6.?6 fi.S4 2.R3 7.45 7.18 7.67 6.03 7.69 'r.74 7.18 8oS6 T.?4 3olS 7.4S 7.69 7.13 . 6.97 7.46 7.27 T.S2 TOSY MEMO IS.7 IS.? IS.9 15.2 IS.1 1508 IS.2 16*3 IS.1 15.3 lfi.0 IS.6 IS.8 16.3 IS*6 '14.2 14.0 IS.3 IS.4 IS*O 13.9 IS*3 isee 16.0 14.8 12.4 9o2 IS.3 16.0 lei*? 15.S Ici.3 IS.& IS.2 1607 16.1 9.3 IS.0 ir,.o 16.0 14.0 15.2 icieo Irt.5 15.6 MEt4AT 44 44 4S 43 d#3 44 43 46 4? 43 4? 414 45 46 4s 40 40 41 44 42 39 43 40 44 40 38 ?S 43 44 44 44 43 45 414 48 46 2? 42 4s 44 39 43 41 43 43 mcv 58.2701 bd.1?42 57#39UO SY.4744 54.IS62 59.1398 S909721 SS.6901 57d37?O 5S.12d2 SV*4490 59.1398 58.5938 60.9272 61*6438 ss.4017 54.7196 S"09080 S6.3300 5900?1? 5b.s2l? 60.DSS9 57*SS40 SS*bSS6 S1.1716 S".1040 SU*33V2 S7.7181 6162813 57.3664 54.794b ss*916d 5d.139S 61.2813 56.0740 59.431S 82e53V? 56.375b ST*034Z 61.7111 Sb.9541 57.640d 56.3961 b7.1809 56.8032 MCH MCKC 20-7947 20-?398 35-6818 35.6814 70.2aob 35.3333 21*0235 35*3488 19.0176 3S*1163 PI.2366 21.1994 3S*9091 35.3408 19.?337 35*4348 PO.6284 19.bIS4 3So9S24 3SoS8l4 ZO.4002 PO.9677 Po.ST29 34-0426 - 35.4545 3S*Illl 2l.so94 3S.4344 21*3699 14.6676 34.6667 35*5600 20.2462 37.0000 21-98?8 19.7183 31*3171 3S.0000 21.0970 3S.7143 *0.1449 al.3667 35.6410 3b*5814 21.SBZI 37.SGOO 20.2020 36.3636 21-8935 37.0000 18.9602 32ob3l6 3R.5060 3698000 PO.S36Y 35.SS14 ??.ZA41 3693636 2n.4644 19.3026 3S.b@ld 3S-2273 19.8960 20.1550 21.169.) 35.5014 34o66b7 34.54SS 19.5093 3497917 ?0.8010 29.S?38 3S.0000 35-7692 20.1342 35*7143 ?o.o2s3 3S.1111 PP.4404 36.3636 20.08bi 35.HV74 PO.3753 3S-3480 20.6321 3b-SNSA 20-6117 3b.0465 20.hO77 36.2791 wac 3.S 6.9 401 3.9 6.8 So4 4.6 ?*1 3.8 5.2 12.1 6.S 509 4.9 5.2 ?.0 Sol 503 8.1 Rol 90a 4.4 4.9 4.8 2.4 ?*1 4.4 4,3 4.9 5.8 4.9 6.0 6.9 5.2 6.7 3.3 4*3 600 6.2 6o? 792 6.6 4.S 6.5 6*2 PHNAB 0.640 0*621 0.451 0*390 3o26f# Oo648 0*598 0.710 00152 0*156 6ol?l 1,36S 1*239 1,666 09728 OoS60 1.530 1.378 29187 2.349 So420 0*660 10421 00960 0*024 19562 0.440 0,688 0*833 1.740 19666 1.380 2.277 0.416 2*613 0.132 0.258 10680 1.302 I.S41 1.440 1.700 1.170 1.170 1.364 LY04AB 2.450 S.86S 3.280 3*276 3.460 4o482 3.542 Sofl22 3.S34 40888 5*324 4.810 4*189 ?.891 4.OS6 6.230 3.264 3*657 S.SOO 4.941 3*036 3o6D8 3.067 3*SS2 2.352 So325 3*?84 3.569 3*626 3*770 2.?44 4*380 4*416 4.524 3*618 2.937 3.913 3.540 4.464 4.623 S.400 4.760 3.060 S.OOS 4.588 MON 0.1 0*2 0.2 0.1 0.0 0*1 0.2 0.3 0.0 0.1 001 093 0.4 0#2 0.? col 001 eel 0&1 0*4 Oo6 0.0 0*2 0.24 0.01 0.21 oti 0604 0021 0.21 0.34 Ooli 0*20 0010 0933 0.19 0.12 Oo42 0*3? Oo33 0.26 0.2? 0.18 0.26 0.18 TABLE 13 TwO YEAR OKAL 41)IET) TOXICITY-ONCOOENICITY STUDY OF FLUOROCARIJON kC-143 IN FEMALE NATS INUIVIUUAL MENUGHAM VALUES --------------------------------------------------------MO-N-TH-=-1-8 ------------------------------------------ DOSE 0 PPM 0 PP04 0 PP" 0 ppm 0 PP" 6 PPM 0 OPH 0 PPM 0 PPM 0 PP" 0 PP04 0 PP" 0 OPM 0 PPM 0 PPM loo PP" 300 pp" 300 pp" loo PP" 300 PPM 300 PPM 300 PP" 300 PP" 300 PPM 300 PPOO 300 PP$d 300 ppm 300 PPM loo PPM 300 PPIA 30 PPOO 30 PP4 30 ppt4 30 PP04 30 OPM 30 PPM 30 PPM 30 PP" 30 PP$4 30 PP" 30 PPM 30 PPM 30 PPt4 30 PP" 30 PPM ANIMAL NIR4s8l MIR4583 HIN4586 NlR4s92 NIN459S NIR4s98 Ntp4sqg NI"4602 NIA4604 NI"4606 WIR4609 NIR4611 NIR4612 NIR46?7 NIR4638 OIR464S OIR4647 OIR4648 OIN46SI OIR4663 OIR4667 OIR467S OIR4679 OIN4694 OIR4688 OIR4690 OIR4693 OIN4694 OIR4696 OIR4698 PIR4?07 PIR4?oq PI"4714 PIN4714 PIN4720 Plk4722 Pl$lf#725 PIR4729 PIR4?32 PIN4733 PIR4737 PIR4748 PIR4?49 PIR4?S? PIR4754 CRYTH 6.16 ?.r,2 7.08 R.04 7.52 ?.44 ?.no 7.72 7.97 S.8s 7.07 6.9s A.2? 7.36 ?.?oi ?.49 ?.S? s.s4 7.60 7.R4 S.04 R.93 T.31 fi.-$? 7.4s 7.21 7.97 7.30 fiegs 7.20 6.6? 6.Ogi 7.46 6.6s 6.46 9;.4? I.S4 7.31 1#.4? A.08 6.91 7.32 I.PA A.17 6.01 MEMO IP.3 IS*6 1405 16.8 IS*3 16.4 16.1 16.6 16.4 12.4 15.S 14*7 16.S 16.2 Ift.4 1594 IS.2 12.0 IS.3 15.7 12.2 16.9 14.4 14.3 lr,.T IS.3 1504 16.4 14.4 15.4 13.S 14.4 Is.3 14.7 14.1 II.R li%.m 15.2 13.7 lg;.7 li.? 14.7 16.2 lh.q 14.5 HFHAT 34 44 41 46 44 4s 44 ##S 47 34 41 41 47 46 4b 44 43 34 43 44 34 48 41 40 45 42 43 46 40 42 38 40 43 39 39 33 404 42 38 44 4",J 42 45 47 41 mcv 55.1948 SO*5106 57.9oy6 57.2139 So.5106 60.403Y 56.4101 58.2902 Sh*9?11 58.1197 by*99is 58.9928 S6.0319 62.5000 57.VB91 58.7450 S6.0032 61.3710 sh.b?H9 Sb.12?4 58.2192 54.3601 56.0076 60.682" 60.4027 So.2524 S3.4523 63.0137 57.5540 58-3333 SbOY715 6h.IIS7 51.640h 50.6466 bO.3715 60.3291 63.66(15 b7*4S'05 !)9.1900 54.454% 62.22h) 57.3770 S7.10hb S7.bp?.@ 60.2013,b MCH 19.4671 20.744? 20.4802 20.09SS PO-3451 22.0430 20.6410 21-502b 20.S?72 21.1966 21.9236 21.1511 19.9516 2P.Oloy 21.1340 ?O.Sbol 20.0793 21.6606 70*1316 ?O.OZSS 70.8904 19.0260 19.6990 pl.yh5b 21.073H 21.2205 19.32?S ?2.46!)oO 20.7194 ?I-3gH4 20.239V 23.0011 2n.bo94 ??.IOS3 21."266 ?I.S?2.e ?P.2AI2 ;10.7y34 Pi.3396 19.4-101 71.9yll 20.0420 70.5564 7n.hHS4 21.2422 MCHC 36.1766 35-4546 3S-3659 36-5217 34.7727 36.4444 3b.5909 36-hatV 34."936 36.4706 37-8049 35.SS3? 3S.l8h4 3S*2174 36.4444 3S.0000 35.34HR 35.2941 .15.5814 3S.6818 3S.01824 3S.0000 35olZIO 3solsoo 34.Hb89 36.4206 3b.0140 35.6S22 36.0000 36.6667 3b.b2h3 36.0000 35.!)616 37.hf*23 36.IS38 3b.?S?b 35.0000 36.190S 3b.OS26 3!i-bhlg 35.3480 3bo.0000 30)-0000 33.9574 3'j.3659 woc 13.2 S.2 4.7 6*S 4.3 S.0 4*8 6.S 4.9 5.1 4.9 S.3 loo Soo 3.8 4,S 4.S 12.6 gi.3 3.? 10.1 708 6.3 6.3 1.1 4.2 6.1 r,.4 S.3 S.3 7.7 3.7 4.9 4.9 10.3 9.2 3.9 %.1 10.R 4.1 S.8 6.6 14.2 gi.y 11.4 PMNAR 6.600 0.208 O.Si? 1.690 I.O?S 0.200 0*384 0.195 0.441 1.632 0.931 o.371 0.840 O.OSO 0.076 2.475 1.215 8.s68 1.376 1.184 3.131 2.6S2 2.016 3.213 1.917 2.142 O.blo 0.964 1.219 0.636 3.080 0.740 0.490 1.176 5.459 5.428 1.014 2.601 4.?12 1.312 1.624 3.366 2.ti7o 1.416 ".s5o LYMAR s.s44 4.836 0 3.BS4 0 4.61JO 0 2.96T 0 4.650 0 4.1211 0 6.305 0 4.410 0 3.060 0 3*675 0 4.664 0 S.950 0 4*900 0 3.610 a 1.4tis 0 2.fJO0 0 3.024 0 3.498 0 2*109 0 ti.ibi 0 4.680 0 4.095 0 2.709 0 4.615 0 loS06 0 4*941 0 4.158 0 3.445 0 4.664 0 4.158 0 2.?Ol 0 4.116 0 3.332 0 4.120 0 3.312 0 2.535 0 2.143 0 6.156 0 2.542 0 3.654 0 2.970 0 4.S92 0 4.012 0 2.280 0 TABLE 13 TwO YLAR ONAL ti)IET) TOxICITY-ONCOUENIC[Ty STUDY OF FLUOROCARHON tC-143 IN PEMALE MATS INDIVIDUAL HFMUtiNAM VALULS --------------------------------------------------------MO-N-T-"0-2-4 ------------------------------------------ DOSE AN114AL ERYTH MEMO NEPOAT HCV MCH HCHC wac PMNAS LYMAki 4 0 ppm NlP4S03 7.48 IS.3 f$2 sh.1497 ko.4s45 36.4206 18.7 12.1329 !).904 0 0 ppm NlN4SS6 7.22 14.3 42 !)B.Ill? 19.0061 34.0476 4.1 1.148 2.952 0 0 ppm NIR4591 7.91 IS.7 4s 56."900 19.H4"3 34*008*) 4.9 0.73S 4.018 0 0 pp" NIN4595 7.97 lb.9 46 57.llh4 19.9490 34.b6b2 4.6 2.714 1.702 0 0 ppm NlA4s9s 7.43 16.4 4? 63.2571 2?.U?2? 34.093b 6.2 29232 3.844 0 0 PPOO NIR4603 7.o7 14*9 44 62.2340 21.07%0 33.ftb3h 4.2 1.092 3.Obb 0 0 PP$4 NIN4606 7.78 1509 46 59.12611 20.1#370 34ob6S2 4.7 I.Ohl 3.525 0 0 P004 N]44611 4.21 10.3 29 0 PPM NIR6614 7.34 16.0 44 68.bu36 24.46Sb 35.5172 9.2 3.496 5.428 0 Sq.9455 Pi.7904 36.3636 S.1 1.989 3.060 0 0 PPM NIR4616 7.24 IS.2 43 a PP" NIR46?6 7.31 14.s 42 0 ppm NIR4628 6.71 13.4 3M 0 PP14 NIW4634 4*f,6 11.7 32 0 PP#4 NIR4fj36 7.9n 16.1 47 r)9.3923 57.455S 61.1vlh 65.h436 59.4937 20.994S 19.d358 2l.b7Hl74.0741 20.3747 35934SR 34.b23" 35.2632 36.Sb2S 34.25b] 4.s 5.4 8.6 12.2 S.0 2.115 2.340 0 2oS92 2.646 0 3.870 4.366 0 5.246 6.222 0 1.6so 3.2SO 0 0 PP" 300 PP" 300 PPM NIN463R OIR4644 01"4646 7.99 7.o? 6oR4 ifi.ki 47 14.0 41 14.2 41 lib.823i s7.y9li 59.rv4lli 21.02b3 19.0020 P0.1602 35.7447 34*1463 34.6341 3.S 0.630 2.695 10 4.8 I.OS6 3.600 0 7.9 2.607 S.293 0 300 PPOO 0104649 7.12 14.6 1#2 58.9080 20.1)1056 34.761'4 8.3 3.6S2 4.399 0 300 PPM OIR4657 6oSS 14.0 37 S6.4014S 21.3740 37.0370 b.0 1.9?0 i.840 0 300 PP4 OIR4659 S.06 11.0 30 59.2Pk4 21.1341 3b.hb6? 8.6 3.9S6 4.3(lb 0 360 PP#4 300 PP14 OIR4661 OIR4663 T.42 8.35 15.0 4? 16.6 45 Sb.6030 53."V?2 2o.el%b 19.t$8o2 35.7143 36."M69 6.s 1.36S 5.070 0 3.0 1.216 2*SOB 0 300 PP" 300 PPM OIR4672 0144679 6.80 7.14 13.9 40 14.6 40 S8.h235 56.0224 20.4412 20.448? 34.7bOO 36*bOGO 6.5 2.600 2.990 0 S.9 3.363 2.419 0 loo ppm OIR4643 7.67 15.1 42. t3*.7sha lg.bm7l 35.9524 8.0 2.000 S.760 0 300 PP#4 OIN4688 7.24 IS.2 4;P lim.0110 PO.')94S 360190S S.4 1.134 4.212 0 300 PP#4 300 PP4 300 PPM 0IM4693 OIR469% OIR469? 7.66 6.R2 ?.RO ili.) 4? 13.0 36 15.1 43 134.H3O3 J2.7859 ')5.leA2 lq.1128 35.9s24 4.6 14.1)blh 3F).Illl 9.3 14.3540 3S.ilb3 5.8 1.794 2.622 0 2.790 6.231 0 l,soo 4.118 0 Ion PP" OIR4701 7*62 15.2 43 30 PP#4 PI"47OR ?.26 15.1 44 %6.4304 60.bOhl 19.9471 ?n.r9m4 35.34m" 34.3182 4.4 1.232 3.124 0 7.8 3.sfja 3.900 0 30 PP" PIR4?11 6.o9 13.7 3P SS.1524 19."839 36*U'j26 13.7 7.672 S.343 0 30 PP04 30 PP" PIN4714 PIR4716 7.11 7.34 15.0 42 IS.0 45 S9.0717 21.0910 3597143 5.8 1.914 3.h28 0 hI.3079 ?0.4360 33.3333 4.4 l.y36 2.288 0 30 PP04 30 PP" 30 PPM 30 PPM 30 ppm PIR4?20 PIR4723 PIR4?26 PIR4729 P144733 6.91 6.3,h 7.64 7.53 R.81 14.9 43 12.0 37 16.3 46 IS.2. 44 11.0 4q 62.22147 sh.17hi Pl.,1630 2o.125o 34.h%12 34.by46 ti.6 3.690 4.472 0 9.q 2.574 7.128 0 t-0.2094 71.33si 3'i*431$ti 6.4 0.640 5.696 0 58.432@o 2n.lHs9 34.b4'35 7.4 2.146 4.884 0 SS.bIN6 lq.e963 34.6939 S.2 2.340 2.7o4 0 C71 30 PPM PIR4?36 7.97 16.4 47 Sts.Ylll. 2o.j772 34.8436 6.2 I.?Ih 4.if#O 0 30 PP#4 PI"4739 4.01 4.4 ?5 t.2.3441 27.IY45 3S.bOOO 12.0 2.760 M.400 0 30 PPM 30 PPM PIN474% PIR4?47 ?.##S 7.09i ILi,4 4S 13.S 3q fto.40?7 95.31ql 70.h7li 14.14"9 34.2222 34.6154 6.2 12.h (i.hfi2 j.332 0 5.4101 b.426 0 30 PP" PIR4752 7.82 16.4 4e) S?.'3448 ?n.y7lY 36.4444 b.6 ?.7f)h 3.762 a .10 PP04 PIR4?rp4 S.Ifi 12.8 3b h2.Sooti 2p.e??? 3s.sssh IS.7 11.77,i 3.611 0 TABLE 14 TWO YEAR ORAL 4DIET) YOXICITY-ONCOGENICITY MEAN BLOOD CHEMISTRY VALUES STUDY OF FLUOROCARBON WITH SIANOARO DEVIATIONS FC-143 GLUCOSE ("GIDL) BLOOD UREA NITROGEN ("G"Ll ALT (JU/L) N MEAN S.DEVO MEAN S.DEV. MEAN S.DEV. IN RATS AST (IU/L MEAN S.01 04ALE MONTH 3 Soo Ppm 30 PP" MONTH 6 300 PPM 30 PPM MONTH 12 04 300 PPM 30 PPM MONTH IS 300 PPm 30 PPM MONTH 24 300 PPM 30 PP" 15 12006 15 129.50 15 134*60 13.74 8036 aoa3 16.3 19.4* 17,1 1*84 2.06 1.46 al.4 &[egg 84.50 2.67 21.94 IS.33 45.3 50.2 59.? 1* 27* 220 IS 11900 IS 123.7 IS 134.90 13.29 Iloll 10*33 I?OS ?0.70 15.90 1936 1.40 1,44 84.1 54*8# 53.34 39?5 29.26 29*34 6907 *?*80 9?.IN 4. 349 45. 14 154.3 15 138.7 15 131-10 26.17 8.85 8.70 16.4 17.5 1602 2050 1.73 1015 83eS 106*IP 77.60 19*45 70.00 S6.S9 1911 132.? 124*4 44* ?6. 94. IS 123.* IS 139*3 IS 120.6 26.39 16.14 27*62 18.1 1706 ifieso 3.36 less 6.46 9401 04.30 69*70 10.69 S509S 33.41 99.1 68* 123.3 62o 116.4 S?o IS 122.5 15 147-10 14 121-3 23.07 13.26 13.72 16*S 1702 16.6 3*16 S.03 6*70 03.4 61.80 62.s 8.10 20.13 10000 64.9 2s. 9S.?* ?9. 68.0 170 t P ta I P 40 OS9 TWO TAILED DUNIOETT OS* TWO TAILED DUNNEIT T ON RAW DATA. T ON RANKED DATA. TABLE 14 MEAN TWO YEAR ORAL (DIET) lOxICITY-ONCOGENICITY BLOOD CHEMISTKY VALUES (TUILI* AL89 TPROT* STUDY OF FLUOROCARBON FC-143 IN RATS ALMP"OS9 CPK* OA) WITH STANDARD DEVIATIOP TOTAL BILIRUOIN (MG/OLI ALBUMIN (GH/DLI TOTAL PROTEIN (OM/DL) ALKALINE PHOSPHAVASE IIU/Ll CREATINE PHOSP"OKINASE IIU/Ll CALC ING/ N 14EAN S60EV "EAN S.UEV MEAN S.DEV MEAN S.PEV MEAN S.OEV "EAN MALE 14ONTH 3 a PPM 300 PPM 30 PPM MONTH 6 0 PP#4 300 PPM 30 PPO MONTH I? 0 PPf4 300 PPM 30 PP" PONT" 10 0 PPM 300 PPM 30 PPN PONT" 24 0 PP" 300 PP" 30 PP" Is 0.6 0.16 is O.ft 0.40 is 0.? 0009 4.4 5.1* 4*?* 0.34 0*29 0.3T is 0.8 0.19 is 0.7 0.22 is 0*5* 0014 4.6 5.40 S.00 0.20 0.31 0.40 14 0.? 0.20 is 0.6 0.12 is 008 0.22 3.7 4.40 3.9 0.20 0*34 0-26 is 0.9 0.3S is 0.7 0.31 is 007 0.2s 3.2 3.?* 3.2 0.38 0.34 0.29 is 0.4 0.2ti a. 11 0.23 is a.20 0.06 3.1* 0.27 14 0.4 0012 2.6 0.30 1 P go *OS* TWO TAILED I P 40 *05o TWO TAILED OUNNETT PUNNETT P NuMban is 14 rom Tnis mern. 7 ON PAW DATA. T ON RANKED DATA. 6.8 0.34 6.5 0-31 6*6 0934 91.1 153.S* 138*70 26.2a $1.06 93.16 100.7 6T.00 60.50 26.46 24*z4 12.6S 11.1 10.8 11.0 Too 6.60 69?9 0*36 9.26 0.33 9?01 14?.30 166.90 00*41 94.$b Syell 89.9 81.4 50.3* 41932 26.66 31*23 11.; 11.10 10.90 6*8 0.27 IDS.9 63.94 606 0.31 166.S* 09*29 609 0-33 l28o3 01.75 19*7 68.3 6?o6 4?961 23.GS 1994S loss 10.6 10.6 rol &.9 7.2 0.61 0.42 Qo45 85.2 164.4- 112.5 $3.?4 ?3*37 92*61 19*9 02.5 106.S 74OS2 4S.81 69623 11.1 10.8 l(P.4 6.9 0.44 7011 IS.55 6.9 0.50 113950 IP.86 6.8 0.39 81.2 86.26 111.1 68.3 ?1.19 68.04 3?o33 20*SS 10.9 10.8 loss* TABLE 14 TwO YIEAR Ut4AL 41)ILY) TOXICITY-ONCOOENICITY sluuy OF fLuONUCAkNON FC-les3 IN MALE RATS INUIVIDUAL SEkt)M LHFMISTRY VALUKS --------------------------------------------------------MO-N-TM-R-J- ---------------------------------------- DOSE ANIMAL GLU HUN ALT AST THILI ALB TPROT ALKPMOS CPK 0 PP" 0 ppm 0 pple 0 ppm 0 ppm 0 ppm 0 ppm 0 PP" 0 ppm 0 PP" 0 PP04 0 ppm 0 ppm 0 ppm 0 PP" 300 ppm 300 ppm 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 300 ppm 300 PPM 300 ppm 300 PPM 30 pp" 30 PPM 30 PP" 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PP14 30 PPM 30 PPM 30 PPM 30 PP$o 30 PPM AIR3%18 112 17 AIR3S27 140 al AIR3%32 138 17 AIP3%34 112 17 AIR]53? 1?9 is AIR3540 102 17 AlR3S42 111 14 AlR3S48 98 14 AiR3%s2 141 16 A103%%9 108 17 A103%bZ 130 16 AlR3S64 lzs li4 AIR3S6S 129 1? AIR3S67 114 Is A103S69 120 14 HIP3%Rs 13S 2? B103587 128 20 HIR3589 139 17 RIP3592 128 17 HIR3593 121 IP. RlR3s9s 131 21 HIR3604 141 19 RIA360S 149i IY 01"3610 124 IY PIR3611 120 17 RIR3617 136 24 RIP3623 )is is 4IR3634 124 22 RIP3640 120 IV RIP3643 IPT 19 CIP3654 120 16 CIR36SS 152 20 CIR366S 130 16 CIR3667 136 16 CIA]66H 13H 16 CIR3673 119 17 CIR3675 139 In CIR3677 13S lb CIR3679 lf#2 Is CIR'iftA3 11#4 114 CIA36my 132 19 CIP36qO 13A 19 CIP3691 12S 16 CIR3692 13R 18 CIR364S 131 17 20 22 420 22 2" 21 22 21 In Is 21 24 20 IY 2b 24 26 ?3 ;eh ?4 2!) 23 25 110 .14 21 33 23 27 30 21 :19 30 ?b 74 20 43 213 23 ?1 ?b 5b )1 30 11) 3h 4e 36 1)0 514 42 43 46 31s 44 si )(1 47 3h C)O ##04 75 37 4h 130 44 42 4,) 14" 6*3 44 51 47 44 7,1 43 fie so Sh 120 51 82 45 37 41) 3h R2 7" S" 53 0.6 o.s o.9 0.6 0.8 o.5 0.7 o.ti 065 o.5 0.4 0.11 -o.9 0.6 o.7 0.5 0.13 O.b I.y o.5 o.7 a.b 0.1 0.6 O.Y 0.7 o.9 0.6 0.5 1.#4 O.b o.7 o.7 o.? 0.6 0.6 0.7 001 O.d o.1 0. 11 11.5 o.1 0.0 n.6 4.2 4.4 4.4 5.1 4.4 4.1 4*4 3.9 4.2 404 4.1 5.1 4.6 4.e 4.3 4.8 4.6 5.1 4.1 4.9 5.0 5*2 S.0 4.9 b*J S.0 593 5.4 !).1 5.7 4.2 4.6 4.1# 4.7 4.6 4.4 4.7 $*I 5.3 5.0 5.3 4.9 4.3 4.1 6.8 6.6 7.1 7.8 ti.6 6.S 6*7 6.5 6.8 6*6 6.5 6.6 6.8 6.S Too 6.3 6.4 6.3 6.5 6.4 6.2 6.8 6.3 6.6 6.s 6*6 6*8 6.2 b.4 7.4 6.3 b.2 6.8 6*4 6.3 6.3 6.9 7.0 7.2 6.7 7.0 6.S b.1 6.3 6.S 107 106 so los 100 so 60 12S ?1 S2 73 125 12h 69 108 140 124 114 162 193 124 142 143 212 IRI 160 128 134 138 217 86 149 147 192 IS6 108 163 IRFI 97 9b lobs 139 145 109 1313 115 104 69 140 144 120 so tio 74 109 NS 72 113 72 134 41 80 47 97 82 60 43 54 7? 53 45 72 11? 41 101 ?1 b9 73 79 59 6? 76 40 53 47 30 b6 59 52 b8 TABLE 14 TWO YTAR ONAL (t)IET) TOXICITY-ONCOOENICITY STUDY OF FLUOH(JCANfiON FC-143 IN MALE RATS INDIVIDUAL SENUM CHEMISTRY VALUES ----------------------------w------------- ---------------MONT"z6 -------------------- ----------- DOSIE ANIMAL OLU SUN ALT AST TkilLi ALIJ TPHOT ALKPMOS CPK 0 ppm AIR3sl9 133 19 le 39 0.6 4.3 6.4 123 70 1 a PPM AIR3S24 139 1? ifl b4 0.8 4.4 7*3 109 82 1 0 ppm AIR3S29 130 16 20 2S 0.6 4.7 6.7 72 bi I 0 PP04 AIR3S33 124 19 2" 41 0.8 do.8 T.S as 119 1 0 ppm 0 ppm AIR353? AIR3%41 109 16 124 is 27 SH 1.1 4.9 ?.o 19 35 so? 4.5 1.2 110 204 1 65 so I 0 ppm AIR3S4? 115 19 29 28 1.1 4.0 TOS 114 62 1 0 ppm AIR3550 12ft Is 2S 43 0.6 4.7 7.0 213 57 11 0 ppm AlR3SS3 99 20 29 53 0.1 4.6 7.1 62 5? 11 0 PP" AIR3%57 109 1? 22 74 1#1 4.7 7*3 120 119 1 0 PP" AiR3s59 ion 17 21 si o.9 4.ti 6.7 so bs 11 0 PP,04 AlR3S62 133 is 2(3 ss 0.6 4.7 6.6 69 79 1 0 ppo AlP3S6? 1214 Is 23 49 0.11 4.b 608 69 as I 0 PPM AlP3ST3 102 17 26 74 1.0 500 7.5 lie 144 1 0 PP" AIR357S 111 17 2!i 67 007 4.4 6.7 ?a 77 1 300 PPN BlR3S03 119 21 29 ST 0.? 5.7 6*4 162 ?1 1 300 PPM RlR3SR4 152 23 81# 112 1.2 S*l 6.7 178 76 1 1 300 PPN RIR3S96 iiq 21 21 f#7 o.9 503 6.6 IS6 80 1 3oO PPM PIR3S98 121 21 92 122 0.8 6.0 1.2 183 106 1 300 PPM 9IR3600 110 22 27 47 1.1 !101 6.3 9T 75 10 300 PPN RIR3604 144 21 60 ob o.5 504 7.0 123 46 11 300 PPO RIA3608 111 19 73 so f).? 5.3 6.3 160 t)l 11 3oO PPM HIR3609 123 21 37 89 1.41 S.S 6.1 127 142 11 300 PP" RIR3613 112 as as 174 o.b 5.0 6.S 109 55 11 3011 PPM ]so ppm BIR3617 9IR3628 12? 23 120 21 3S 73 0.6 Sob 7.0 73 9s 0.6 5.8 6.9 162 56 11 172 110 11 300 PP" RIP3629 122 20 37 79 0.6 4.9 6.3 102 63 1( 300 PPM RIP3631 117 19 34 To 0.5 5.S 6.6 166 6S 14 300 PPM OIR3633 129 20 111 130 O.b 5.2 6.5 211 115 11 300 PPM BIR364? 128 id 24 56 0.6 5.7 6.6 102 92 11 30 PPM CIP3646 146 19 3b 64 0.6 S.0 6es 94 so 11 30 PPM CIP]6so 151 16 53 83 0.4 4.9 6.5 163 91 10 30 PPM CIR36S6 149 is k3i 212 0.5 4.8 6.5 las 64 10 30 PPM CIR36SO 13? is 48 6s 0.4 4.y 6.4 ifis 4? 10 30 PPM CIR3660 138 is 25 49 0.4 4.9 6.7 79 43 10 30 PP" CIR3664 13A 16 61 IIR 0.4 4.5 6.5 121 20 10 30 PPM CIR3665 133 16 a? 14H 0.4 409 6*8 iss 40 11 30 PPM CIR3667 133 17 39 72 0.4 S.0 6.7 1?2 41 in 30 PPM CIA3679 144 16 39 71 0.6 5.8 7.6 9? IS? 11 Ch .30 PPM CIP3680 130 is 49 7? 0.4 S.6 7.1 13S 38 11 @4 30 PPM CIR36R2 122 16 is 139 0.4 4.4 6*9 209 so ii 30 PPM CIR36R? 112 Is 30 74 0.9 S.3 7.1 IS8 63 1] 30 PPM CIN3669 128 13 ieo 3Y 0.4 5.2 6.ft IS6 si in 30 PPM CIN3691 134 is 53 lot) 0.3 4.4 6.4 134 4s 10 30 PPM CIP3694 129 1? 28 540 o.5 Sol 6.7 148 b3 10 TABLE 14 TWO YEAR ORAL 40ILT) STUDY UF FLUOROCARBON INDIVIDUAL SERUM TOXICITY-ONCOGENICITY FC-143 IN MALE WAYS CHEMISTRY VALUES -----------------------------------------f-t-f--t-----m -------ft MONTH=12 -----------w-----------f-t--------------- DOSE ANIMAL GLU SUN ALT AST TRILI ALB YPROT ALKPMOS CPK 0 PPM AiR3SI6 14? la 22 56 0.9 3.6 6.9 139 ?2 0 ppm AIR3SI? ISO 16 16 40 O.S 3.8 ?01 104 43 0 PPM AIR3S20 124 16 is 1#3 0.4 3*11 6*6 49 42 0 PPM AIR3S22 134 is bs 123 0.6 3.? 6.7 100 bi 0 PP" AIRIS2? iss is 37 67 0.6 3.9 6*6 102 no 0 pem AlR3S35 141 17 23 Sb 0.6 3.8 6.8 113 103 0 PPM AIR3543 183 1? 33 RS 1.0 3.9 ?.o 115 as 0 PP" AIR3S46 176 1? 37 lioi o.9 4.41 6.9 la? 234 0 PPP AIR35SO ins le 32 79 1.0 3.') 6.9 225 89 0 PP" AIR3%Sl IbS 20 41 ob 006 3*9 6.7 95 6S 0 PP" AIR3SS4 214 is 07 212 0.6 3ob 6.3 as Jos 0 PPM AIR3S60 123 14 Is 43 0.1 3*3 6.2 48 so 0 PPM AIRIS?O IPS 9 23 54 nos 3.6 6*S ?2 39 0 PPM AIR357S 143 16 23 63 0.4 3.S 6.9 ?0 so 0 PPM AIR3580 146 1? 11 S9 0.? 3*9 7.1 IS2 66 300 PPM BIR3SS4 151 1? 133 lbb 0.6 3.? 6.3 20S so loo PPM BIR3S@S 130 17 35 tiv o.? 4.7 6.9 14S 108 300 PPM RIR3589 144 is ios 116 0.4 4.? 6*8 IS3 84 300 PPM RlR3S92 1?? lb io sv o.5 4.1 6.S Ila 67 3o8 PPM RIR359% li#2 17 162 171 0.5 443 6*6 212 64 300 PPM BIR3604 IS3 Is lbb 202 0.6 3*9 609 ?OR 6? 300 PPM BIR3613 145 )a b4 13? n.1 3.9 6.4 103 ?a 300 PPM PIR361? 12? 16 200 23h o.? 4*4 ?.2 23S 10? 308 PP" HIR3620 ISO 19 ios 10b 0.4 4.b 65 li? 39 300 PPM 9IR3&22 131 22 ?6 126 0.7 4.? ?.3 190 56 300 PPM 9IR36?6 136 1? so S3 0.8 4.3 ?.o ISO 5? lee ppm DIR36?7 13S 1? 46 66 n.? 4.2 ?.1 101 40 300 PPM RIR3638 138 20 46 ?S 0.7 4.5 6.6 105 38 300 PPO AIR3642 142 1? h4 a? 0.? 4.? ?.1 139 54 300 PPM HIR3643 129 17 261 326 0.7 4.7 7.1 309 96 30 PPM CIA3649 139 16 39 76 O.d 4.1 ?.o 89 91 30 PPM CIR36SO 132 1? 46 93 o.b 4.3 ?'1 168 56 30 PPM CIP3652 izis 16 54 is 0.6 3.7 1.1 177 is 30 PPM CIR36t-3 147 17 7,1 103 0.01 3.tj 6.9 82 54 30 PPM CIR3666 123 is 241 436 o.6 3.9 7.o 21S 66 30 PPM CIR3670 139 17 94 127 0.8 3.0 6*8 IS4 41 30 PPM CI"1672 120 If$ los 113" 0.1 3.0 6.7 44 110 30 PPM CIP3676 130 it, 3? t%4 0.41 3.6 7.4 128 66 30 PPM CIP3679 137 16 S2 94 O.V 4.6 7.6 93' 73 30 PPM CIA3680 132 17 ISY .193 o.6 4.1 6.9 14S 49 00 30 PPM CIR3681 129 18 62 121 1.4 4.0 7.2 124 98 30 PP" CIR1683 141 16 n 65 1.1 *.D 6.9 67 by 30 PPM CIN3605 122 IT 1%3 73 o.1 4.0 6.5 lc)9 ss 30 PPM CIR3691 132 13 NJ 126 o.? 3.7 b.4 131 50# 30 PPM CIR3694 iis 16 39 62 0.7 397 6.5 109 51 TABLE 14 TWO YEAR ORAL ADIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FC-143 IN MALE RATS INUIVIDUAL SERUM C"EMISTRY VALUES --------------------------------------- -----------------MONTM=IS -------------- DOSE AN114AL OLU NUN ALT AST THILI ALB TPROT a ppm AIR3519 151 19 41 94 007 3*2 6.8 0 ppm AIR3S21 12S 29 59 317 002 2.1 5.5 0 ppm AIR3S28 148 19 24 S!i 006 3*2 700 0 ppm AIR3%31 143 Is 42 96 1.0 304 7*4 0 PP" AIR3S36 129 is 38 93 007 3.3 608 0 PP$4 AIR3539 132 16 24 54 009 3.7 801 0 PPN AlR3S42 10? is 30 61 1.1 3*4 702 0 PPM AIR3SS2 117 21 23 54 101 3.3 7.4 0 ppm AIR3553 12? 17 44 74 0.9 3.4 los 0 PPM AIR3SSS 140 17 3s R4 1.1 393 793 0 PPM AIR3S61 135 IT 26 61 009 3.4 ?o6 0 PPN AIR356S IZ6 is 23 62 0.,g 3*3 6*6 0 PP" AIR3%67 134 1? 34 133 0.9 3*2 To? 0 PPM AIR3%74 91 17 24 79 0.2 246 6*? 0 PP" AIR35?7 46 IT 45 168 1*6 3.4 7*3 300 PPM HIR3SO3 13S 19 31 42 0*4 3.8 sea 3oo PPm HIR3Sq3 124 17 as 109 0.9 3.8 ?*S 300 PPM BIR3%Q6 137 19 39 68 1.0 3.4 ?*4 300 PPM PIR3600 140 19 92 139 0.4 490 6.9 300 PP" RIP3601 13A 14 96 132 006 3.R 700 300 PPM HIR360S 136 20 51 68 0*6 3.9 ?00 300 PP" BIR3608 124 14 121* 163 004 3.2 6.S 300 PPM HIR3610 ISO 19 is 117 0.7 3.9 700 300 PPM PIP3612 14A 19 118 205 0.8 3.4 6*6 300 PPM SIP3615 117 17 63 101 0.8 4*1 ?.4 300 PPM 9IR3624 lif) 1@ 42 95 0.4 209 700 300 PPM BIR3632 The 19 91 142 1.1 0*0 7.3 300 PPN 8103641 145 16 47 78 0.9 3.6 6*9 300 PP" BIR3644 173 is 25d 2913 lob 397 7.0 300 ppm RIP3645 136 16 53 9s 0.7 4.0 6.8 30 PP" CIR3647 116 12 40 ily 0.3 2*4 7.8 30 PPM CIR36SI 14? 13 37 60 096 3.4 ?00 30 PP$4 CIR36S4 134 16 43 100 0.8 3*2 ?.1 30 PPm CIR36SS IS6 16 71 ION 0.6 3.3 6.7 30 PPM CIR3662 31 39 53 161 o.1 2.9 8.3 30 PPM CIR3663 121 lb so 120 0.7 3.1 7*1 30 PPM CIN3664 12S 16 97 IS3 0.8 3.4 6.9 30 ppm CIP366? 134 is 02 IS6 o.8 3*4 7.2 30 PP" CIR3668 128 is 160 209 0.1 3.5 ?.1 C)i 30 PPM CIR3676 110 17 34 60 1.1 3.0 ?.6 30 PP" CIR3679 123 13 41 89 1.0 3.5 ?*S 30 PPM CIR3601 136 12 45 By o.? 3.2 ?02 30 PPM CIR340S 113 16 34 64 o.6 3.2 6.9 30 PPo4 CIR3689 126 is 62 YS o.? 3.4 6.7 30 PP04 CIR3695 114 14 39 87 005 3.4 607 --------------------- ALKPHOS 128 164 ST S6 113 82 41 ss 6S 124 90 a? 66 82 68 146 214 113 142 213 172 IT? 202 166 129 106 233 156 413 ISO ios 138 9? 134 100 69 133 124 186 ios 68 82 9s IS6 101 CPK CA 37 10 79 10 39 11 34 12 96 10 3S 11 49 11 41 12 83 it 108 11 59 10 41 9 77 10 a? 10 334 12 59 11 45 10 6T 11 54 11 83 11 ST 10 64 ? ss 11 212 11 104 11 152 9 53 12 52 9 109 9 71 11 73 10 46 9 86 10 71 9 327 12 186 10 ?1 9 79 10 iis 11 80 9 110 10 89 9 109 56 10 100 9 TABLE 14 TWO YEAR ONAL il)lt.T)TOXICITY-ONCOGENICITY STUDY UF FLUONOCANHON FC-143 IN MALE RATS INDIVIDUAL SEKUM CHEMISTRY VALUES --------------------------------------------------------MO-N-T-HR-2-4 ---------------w -------------------- DOSE ANIMAL OLU IIUN ALT AST T"ILI AL" TPROT ALKPHOS CPK 0 ppm 0 ppm 0 ppm 0 PP#4 0 PPM 0 ppm 0 PPM a PP" 0 PP" 0 PPM 0 PP" 0 PPM 0 ppm 0 PPM a PPM 300 ppm 300 PP" 300 ppm 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 300 PP" loo PPM loo ppm 300 PPM 300 PP" 300 pp" 300 PP" 30 PPM 30 PPM 30 PP$4 30 PPM 30 PPM 30 PPM 30 PPM 30 PPID 30 PPO 30 PPM 30 PPM 30 PPM 30 PPP 30 PPM 30 PPM AIR3518 AIR3%24 AIR3526 AIRIS31 AIR3S34 AIR3S38 AIR3S42 AIR3548 AlR3SS4 AIR3S%l AIR3S62 AIR3%64 AIR3569 AIRIS?3 AIR3S?R RIR3SAI N IR3SRS HIR3S91 BIR3S94 8IR3S9? HIR]601 RIP360S HIR3608 BIR3611 RIP3610 HIR3623 RIR3630 OIR3633 HIR3636 ol"3641 CIR3646 CIR36SO CIN36S4 CIR36SS CIN3663 CIA3667 CIR3670 CIR36?2 CIR36?6 CIA3679 CIR3602 CIR36k4 Clk3609 CIN3691 CIR3694 130 14 13ft 23 141 is 109 14 67 20 147 12 96 Is 122 is ISR 17 If? 16 134 17 116 19 143 22 los 14 its is 120 is iss 17 147 17 IS9 16 143 is 146 16 IS? 14 136 If# 1?" 19 169 17 142 14 137 17 163 34 153 13 IS2 20 144 17 147 14 133 13 123 is 115 14 107 Is tin Ljl 1()T 10 125 39 122 16 fib 1" 13? 12 126 Is 99 is 113 is 2t) ;eg 28 36 21 30 lb 32 43 42 33 27 29 29 S3 41 111 "a is 61# 47 43 41 41 02 &0 hi 62 t)2 59 47 35 b4 d$3 27 dbs 6#6 29 33 41 39 ho 43 41 '45 gi2 4i! 47 60 142 69 so 40 74 66 S3 so 74 Sip 97 sy 133 130 109 117 68 59 is 56 152 93 101 110 91 03 TO ,it "9 66 43 ?Lj 105 44 %2 S9 64 402 64 74 71) 0.2 O.b 0.2 003 0.-1 a.2 0.6 0.4 n..e o.b 001 D.S 1.0 nor 0.4 002 0*2 0.3 003 0.2 0.2 Ool 0.2 0.3 004! 0.3 o.3 0.2 0.2 a.3 0*4 0.3 n.3 0.3 0.6 0.11 0.1 0.2 O.b n*4 0.) 0.4 0.2 0.3 Oo'4 2.6 i!.7 3.0 3.1 2.7 2.8 3.0 2.9 3.0 3.0 2*4 2.S 267 3*1 2.b 3.4 3*2 2.9 3*4 2.9 3*0 3#3 2.01 3.S 301 3.b 3.4 2.7 3.o 3.0 3*1 ?." 2.8 3.2 2.6 3.0 2.3 2.6 P.2 2.9 3.0 3.1 2.,) 3.0 3.1 6.6 7.1 boo 7.1 5.9 6.4 7.0 too 6-6 7.3 606 6.9 7.4 7.7 7.3 606 6.8 ?.q 7.1 to.4 6.2 ?.4 6.S bell 6*9 7.3 ?.a 6.7 6.4 6*9 6.6 7.1 6.7 6." 6.0 6.8 b.4 ?.? 6.6 ?.1 7.0 6.% 6.3 b.3 7.3 lie ?4 39 ss 61 66 37 97 29 109 68 ?y Cis 86 77 97 122 132 162 74 127 99 leg 133 ios 107 111 121 ?S 129 62 100 102 102 47 103 is 20 91 64 104 ?1 118 6s ag tit bi 63 72 lvo 69 S4 108 73 90 76 le? 299 101 146 82 S? ly 116 95 as 03 06 S? 54 162 114 si 06 ST 64 71 74 47 !)1 76 44 4? 77 57 105 "b 114 73 tio TABLE 15 TWO YEAR ORAL IDIET) TOXICITY-UNCOOLNICIIY MEAN BLUOD CHEMISTRY VALUES STUDY OF FLUUR(ICARBON FC-143 WITH STANOAND DEVIATIONS GLUCOSE IMG/DLI SLOOU URLA NITROGEN (MOTOL) N MEAN S.DEV. MEAN S.DEV. ALT IIU/Li MEAN S.DEV. IN RATS AST 4JU/Ll MEAN S.DE FEMALE MONTH 3 0 ppm 300 PPM 30 PPM MONTH 6 0 PPM 300 PPM 30 PPM MONTH 12 0 ppm 300 PPM 30 PP" 14ONTH 10 0 ppm 300 PPM 30 PPM MONTH 24 0 PP" 300 PPm 30 PPM IS 138.9 is 132.9 IS 332.1 9.?v 10*96 12.06 19.7 24.50 lb6s 1.&2 3.41 P.07 a2.6 *Bb-2 19.4 4.87 6.72 3.10 15 IS4.8 IS 133.60 IS 128.69 14.98 9.61 13.41 21.6 20.1 19.10 3.22 2.96 2.00 a3os 14-3 as.? 17.20 20.46 14*SS IS 134.9 IS 135-3 IS 135.4 1().Sl 8.18 10.35 19.8 21.2 19.9 2.14 5.21 2.43 $4.1 as.6 $7.1 IS.17 21.59 12.94 IS 123.5 15 120.0 15 12Z.2 IS.SI 9.39 15.39 18.1 16.7 20.1 P.49 3.37 4.02 6a.? 66.4 99.4 11.60 6.36 14.31 IS J22-2 13.75 IS 115-3 18.72 IS ll).4 IS.23 1?.9 16.2 15.3 4.10 3.?6 3.3b 6000 63.1 88.6 10.11 25.27 9.61 IP OS9 TWO TAILED f)uNNITT T ON RAN UATA. P oSt TWO IAILLO DUNNETT T ON RANKLO DATA. 48.0 9. 51.6 13. 44.9 S. 6907 38* 69.2 29. 69*9 28. 60.1 66.2 72.6 38. 30. 36* 7091 63.S 63.5 24*4 Is. 25.1 6?.e 61.0 63.5 30.0 35.2 12.9 TABTZ 15 TWO YEAR ONAL IDIET) ToxICITY-(INCOUENICITY MEAN BLOOD CHEMISTRY VALUES ITBILIT ALUT TPROTO STtlOy OF FLUOROCARBON FC-143 IN RA ALOPHOSE CPK* CA) WITH STANDARD DE TOTAL BILTRUBIN IMG/ULI ALBUMIN IGM/OL) 70TAL PHUTEIN IGM/DL) ALKALINE PHOSPMATASE IIU/Li CREATINE PNOSPHOKINASE IIU/L) N MEAN S.DEV MEAN S.OEV MEAN S.UEV MEAN S.OEV MEAN S.DEV FEMALE MONTH 3 300 PPM 30 PPM MONTH 6 ;-;;m 300 PPM 30 PPM MONTH 12 p 300 PPM 30 PPM MONTH 14 ;-;;m 300 PPM 30 PP14 MONTH ?A 300 PPN 30 PP$4 Is 0.6 0018 Is O.S* 0.11 Is 0*6 0.09 S.3 0.45 5.0 0.52 Soo 0.41 7.2 6.90 loo 0*41 0.41 0.32 83.7 69.1 69*9 32.29 PS.36 2S.90 93.9 87.7 ob.? sio44 37012 21.06 15 0.6 0. 1lb 5.9 0.6b is O.S 0.09 5.6 0.46 is 0.6 0.10 S*S 0-66 ?04 0.64 ?.4 0.34 ?.3 0.5? ??.a 62.1 80.9 SO.SE 22.06 IS.?6 56.5 66.? 89.2 140?9 21.1? 4S.03 is 0.6 0*38 15 0.6 0021 is 0.8 0.21 4.3 0*26 4.2 0.32 4.4 0.26 ?*3 O*S2 ?.1 0046 ?.S 0.46 ?6,S 9101 89.4 90*01 42-66 89.87 S4.6 41.3 ?6.? 20002 11952 ?8.42 Is 0.6 0.26 is 0.6 0.23 15 0.6 0.24 3.9 0*23 3.9 0.28 3.8 0.26 ?.9 0.5? 7.8 004? 8.3 0-?3 65.5 ?691 39.?* 32#19 18*36 13*41 3?.3 3S.1 2?06 9.81 9064 19*18 is 0.6 0.31 ts 0.4 0.1? is O.S 0.21 3.4 0.21 3.4 0.28 3.3 0-38 ?.b 0*69 ?.4 0.56 ?*2 O.?S 68.? 63.1 S&O? 93.39 19-69 19.91 68.4 6?.? ?1*3 32923 2?oO6 35*?3 0 1 P ce oOSt TWO TAILED 0 1 P CR OS9 TWO TAILED DTINNETY T ON RAW DATA. DUNNETY T ON RANKED DATA. :@.000 0400 OCCOOCPOO xxxzzzzzzzzzzzzzzzzzzzzzzzzzzzzxxxzzzxszzzzzz r. vvvvvvvvvvvvvvmcoooocoooococoozzzzzzzzzzzzzzz 0 0 00 .POO 0 a@o 41- 0.0 41-41,00 00* a-o;a-oo ow 40.4po 40-0.0 00 &OPP 001*-LPP 0 WNNN w I 0*01 00 & 0 a- v I 4 wo.4-4 r wow M-.,r*6.4..do *Nil-%O NOO 0#0 4310 ON 4 09@W OWW-,04 .dwo 0-4,0 a W a N= QNJ NWNNNNN NNNN rwu rN%d CNP NNN Ca NWWNNWNWW CP-Z-CNONW a -4v. WN 0 0 rj ru c z ru Lr 10 CD a cc -< .4 z 0m 1 z r. 30 x 4@WOW** @PO* wo am* %p I L4 30 c c -4 z XZ tLi 00 41 a- -4-0 6n- W -d 4 -4wa w 4 a 4N a 4 4 a a 0 .dwoo a a.- 0- -40 am- M-@o@W- N NNQ- a 0-- 40 mo 4 Dr"n rxc r_ 1r0- 0 rr, m 61 z cc ------------- -------pm TABLE 15 TWO YLAN OWAL (UIETI TOX[CtTY-ONC06ENICITY STUDY UF FLUOROCARHON PC-143 IN FLMALE MATS INI)TVIDUAL SERUM CHEMISTHY VALUES --------------------------------------------------------MO-N-T"-w-f-i ---------------------------------------- DOSE ANIMAL GLU t]UN ALT AST T"ILI AL" TPROT ALKPHOS CPK 0 PP" NIR4SO2 I?R 21 21 3r o.9 1.2 1.7 0 PPM NIP4584 172 22 55 Ilk 0.6 S.d 8.9 0 ppm NIP4586 159 23 ad 103 o.5 6.li 7.9 0 PP$4 HIR4S90 103 22 26 4ti D.b S.6 7.2 137 11 125 55 es 41 101 69 0 ppm NlR4S98 141 20 20 0 pppi MIR4603 161 22 32 0 ppm NIA4607 147 23 3S 48 0.6 5.8 7.2 71 0.4 6.1 T.S 9b o.S S.S 7.0 si 33 39 8s, 61 49 0 PP" NIR4616 ISO le 25 S6 0.4 b.2 6.9 ss 52 0 PP" NIP4619 140 18 26 0 PP" NIR4621 154 20 26 0 PPM NIR4622 160 Is 34 ST O.ft 6.0 7.2 47 o.1 6.9 8.1 ?9 O.b S.6 7.2 6)? 66 51 73 Ina so 0 PPM MIR4629 130 20 33 0 ppp NIR4631 137 22 25 S" .0.4 4.9 6.3 S,3 0.4 5.2 6.7 96 55 90 32 0 ppo NIR463? IS4 P4 27 30 o.? b.4 8.0 so 59 0 PP" NIR4639 156 31 30 62 0*6 6.% 7.6 300 PPM OIR4650 133 In 76 122 0.6 6.2 7.4 300 PPM OIR46S3 120 19 30 so 0.1) 6.2 ?.b 300 PP" OIR46%7 123 IV ?li its 0.5 5.2 ?.S 300 PPM OIR4660 136 PS 22 fit 0.6 Sol 1.3 S9 57 S9 S2 111 63 ?b 60 To 126 loo PPM OIR4661 12S 17 1h 43 0.4 4.9 ?.0 300 PP" OIR4670 lsi 19 14 30 0.6 6.0 7.9 300 ppm OIR4673 12S 24 66 too 0.4 b.7 7.Ci 300 PPM OIR4681 12S 21 34 40 O.ti 5.4 '?.S so B4 41 80 91 54 at 51 300 PPM OIR469? lie 22 2b 44 0.5 5." 7.7 300 PPM OIR4692 142 22 23 42 0.4 Sol ?*4 300 PPM OIR4&93 13? 24 23 41 o.6 5.1 7.0 S6 51 %1 53 97 $so 300 PPM OIR4694 144 1? 23 3h 0.6 5.? 6.8 ?3 83 300 PP" OIR4698 13S 26 24 53 0.6 S.6 7.3 100 69 300 PPM OIR4699 14? 10 27 4s n.5 S.S 7.0 116 so 300 PPM OIR4700 13S 20 31 fi4 o.1 b.3 8.0 101 ?? 30 PP" PI"4710 109 19 25 54 0.5 4.6 b.? 110 134 30 PPM PIR471i IS? 2? 41 To 0.6 6.0 Rol 140 S2 30 PPM PIR4717 144 17 3? 30 PPM PIR4?19 116 20 40 30 PPM PIR4?29 144 18 59 33 o.1 6.1 7.8 63 o.? 6.0 707 61 o.? 6.3 8.0 9s 49 To III 93 103 30 PPM PIR4?31 140 19 27 42 0.5 4.4 0).3 100 311 30 PPM PIR4?32 122 20 26 3" O.h 5*1 1.3 68 74 30 PPM PIR4733 127 lb 22 40 0.1 5.0 6.6 57 78 30 PPM PIR4737 140 IR 2s 40 0.5 5.3 7.4 74 45 -4 30 PPP -PIR4?40 133 21 2H 53 0.6 5.4 7.o 99 51 4@b 30 PPM PIR4?43 112 19 27 41 0.5 4.b 7.1 42 133 30 ppm PIR474S 133 14 23 75 nos 4.8 b.7 so 205 30 PPM PIR4?46 111 21 5" 102 o.5 6.1 7.04 30 PPM PIR4?49 125 21 35 47 O.d b.2 7.7 91 107 61 ho 30 PPM PIR47SO its 20 6? 140 0.1 5.$1 7.6' 6s 72 TABLE 15 TWO YLAR ORAL (IPIET) TOXICITY-ONLOUENICITY STUDY OF FLUOROCA14tiON @C-143 IN FLP4ALL MATS INUIVIDUAL SERUM CtiEMISTRY VALUES --------------------------------------------------------MO-N-T-"8-1-2 --------------------------------------- DOSE 0 PP" 0 ppm 0 ppm 0 PP" 0 PP" 0 PPN 0 PPM 0 ppm 0 ppp 0 PPM 0 ppp 0 PP" 0 PP" 0 ppm 0 PP$4 300 PPN 300 PPM 308 PPM 300 PPM 300 PPM 300 PPM 3oO PPt4. 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 300 PPM 30 PP04 30 PPM 30 PP" 30 PPM 30 PPM 30 PPOO 30 PPM 30 PPM 30 PPM 30 PPN 30 PP" 30 PPM 30 PPm 30 PPM 30 PPM ANIMAL NlR4STO NIR4SR2 NIR458S NIR4sa8 NlR4SR9 NlR4s9o NIR4&01 NIR4608 NIR4610 HIP4620 NIR4629 NIR4630 NIP4631 NIR4&32 NIP4640 OIR4642 OIR46s2 OIR465S OIR4656 OIR4664 OIR4666 OIR4664 OIR4611 OIR4674 OIR4676 OIR4607 OIR4689 OIR4692 OIR4699 OIR4704 PIP4711 PIP4?14 PIR471S PIR4716 PIR4?17 PIR4??l PIR412S PIR4727 PIR4?29 PIA4734 PIR4?42 PIR4?43 PIR4749 PIP47so PIR47SS OLU HUN 146 24 124 Is 132 24 137 20 132 19 136 19 143 20 131 18 127 21 146 19 136 18 IS? 22 128 20 113 is 13S 17 137 lb 12A 20 132 24 136 22 1?? 25 125 Is 129 23 139 is 125 22 134 1? 132 37 148 22 146 la 149 19 143 is 141 17 li@l 17 142 19 12A 19 134 22 124 19 159 ly 149 19 131 IN 13S 19 135 25 12,i 21 146 27 130 1$ 131 ly ALT AST THILI 27 48 22 42 33 60 23 47 67 1#13 24 46 40 sv 24 51 2b 62 31 si 6? 119 42 79 41 94 19 33 26 47 2h 51 112 163 28 si 32 56 29 S4 26 57 23 48 38 59 *0 79 41 fts 26 52 35 S2 32 so 38 53 si 103 3h 6i?@ 29 S7 49 013 36 Cl!) 11 51 39 7? 76 33 4" 37 sti 36 S" 30 ss 2b @194 42 83 3b 74 Ih 43 1.2 1.5 0." o.5 o.? 0.6 0.6 1.1 1.0 006 0.4 0.5 1.1# o.2 0.5 o.6 o.1 0.6 0.6 0.4 0.6 1.0 0.4 0.9 o.3 0.4 o.6 0.9 0.4 1.2 0.6 O.d 0.6 n.8 1.0 0.4 0.5 o.? 0.7 0." 1.0 0.9 O.ti O.Y ALS 4.1 4.7 4.5 4*4 4.6 4.5 401 4.2 4.1 4.1 3.9 3.0 4.4 4.3 4.4 4.s 4.6 4.6 4.6 4.3 3.7 4*3 4.3 4.0 4.3 3.ti #s.2 4.2 ##.S 4.1 *.? 4.7 4.1 4.0 4.2 4.7 4.1 4.7 4.4 4.3 4.0 4.5 4.6 4.4 '*.4 TPROT 7.1 8*6 7.6 7.0 ?.? 7.3 703 ?.2 7.1 7.0 6.7 6*6 7.4 0*2 7.2 7.1 7.6 705 ?.4 7.0 6.6 7.0 7.1 6.7 7.o 6*6 6.9 792 ?.a 6*3 9*1 8.3 7.2 6*9 7.7 7.9 6.9 T.? 7.4 1.3 6.9 ".2 7.5 7.5 7.6 ALKPMOS 71 134 R4 44 104 84 12? 39 72 71 no S4 99 43 42 39 iis 137 46 99 44 101 tib iss 132 124 96 39 142 41 121 94 96 102 131 1?2 in2 108 tis 76 a? 22 93 48 104 CPK 6;e 82 42 56 so 3481 60 104 55 40 3? ?9 76 47 31 42 36 41 40 51 37 67 so 40 41 lb 44 38 38 'j2 39 271 35 42 21#0 42 26 4A 39 59 46 4s 14S 44 TABLE 15 TWO YLAH ORAL IDIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCAROON FC-143 IN FEMALE RATS INUIVIDUAL SENUM CHEMISTRY VALUES --------------------------------------------------------M-O-N-T-"ulO -------------------------p------------- DOSE ANIMAL GLU BUN ALT AST THILI ALH TPROT ALKPHOS CPR 0 PPM mia4sal 1211 22 37 so 0.3 3-3 6*4 as 33 0 PP" NIR4583 120 17 iko 64 o.d 399 6*4 51 39 0 PP" NlR4SA6 98 19 S9 93 0.3 3*? 7.8 IS2 27 0 PP" NIR4%92 107 23 35 S3 0.6 4.2 604 91 42 a PP" HIR4S9S lift is 71 132 0.4 4.0 8.6 63 37 a PP#4 NIR4%98 123 17 ss 79 0.5 4.0 7.8 40 32 0 PP" NIR4S99 133 16 69 106 oes 4.0 7.7 53 47 a PON NIP4602 103 21 43 se 0.0 f#.O 862 S5 37 0 PPM NIR4604 ISO 14 38 44 0.5 3.8 7.4 62 27 0 ppm NIR4606 1?6 la so 79 0.1 3.8 ?*a 68 2? 0 PP" NIP4609 110 is 411 bs 1.0 462 8.6 S6 33 0 PPM HIP4611 143 19 40 49 6.6 4.0 705 1? 36 0 PPM HIP4612 138 le 42 49 1.2 3.8 ?.9 60 66 a PPM NIR4627 116 16 42 65 0.6 3*7 ?.a 27 41 0 ppm NIP4638 141 18 !i4 65 0.10 400 6*3 ?9 35 300 PPM OIR464S 119 21 so 6s O.S 3.7 7.2 36 31 300 PPM OIR4647 117 19 56 49 1.2 4.1 ass 66 35 300 PPM OIR464A 121 21 51 61 0.3 3.4 6.6 S9 is 300 PPM OIR4651 130 20 33 48 0.5 4.0 7.4 ios 37 300 PPM OIR4663 134 13 49 sy 0.7 4.3 8.2 ?4 26 300 PP" OIR4667 1?1 19 S4 112 0.3 3.4 706 149 43 3eO PPM OIR4675 116 24 sie ol 0.0 3.6 802 is 54 300 PP" OIR4679 Ila lb 42 S2 0.6 3.8 8.1 65 26 300 PPM OIR4684 109 is 49 47 e.5 490 6.1 63 32 300 PPM OIR46AS 128 in 45 fis O.S 4*0 7.9 90 26 Ion PP" OIR4690 1?4 13 49 66 0.5 4.2 1.9 79 29 300 PP" OIR4693 IIR 20 44 95 Oeb 4.2 7.8 91 38 300 PP" OIR4694 134 is 44 47 0.6 4.0 Roo bs 40 300 PPM OIR4696 112 21 37 51 0*3 3.6 To? 30 49 300 PPM OIR4698 99 23 f#l ST 0.5 3.9 7.9 89 42 30 PPM PIR4?07 102 ieo 10 62 0.4 3.9 7.7 S3 30 30 PPM PIR4?09 Ila 22 51 60 o.? 3.6 8.7 S3 16 30 PPM PIR4?14 123 20 3b 42 o.7 3.9 9.4 S3 24 30 PPM PIR4718 1?? 24 45 51 O.Y 3*9 8.9 30 is 30 PPM PI"4??O 9A 20 2ti S6 0.6 3.6 8*0 49 41 30 PP" PIR47?z 126 16 21# 6S 0.3 3#3 6.7 31 37 30 PPM PIR4T25 14A 14 21 si 0.3 3.6 706 47 25 30 PP" PIR4?29 127 2? 5T 40 0.8 3.Fi O.R 42 11 30 PPM PIR4?32 120 19 3-0 59 0.6 3.8 8.0 40 16 -4 30 PPM FiIR4?33 143 21 60 76 0.7 4.2 8*6 41 22 30 PPM PIR4?37 136 23 40 60 0.8 3.6 Soo S? is 30 PP" PIR4748 94 13 24 1#01 O.S 3.b 8.0 21 17 30 PPM PIR4?49 116 16 42 148 0.6 4.3 9*0 13 89 30 PPM PIR4lS2 127 22 61 52 1.2 3.9 9.3 44 3S 30 PPM PIR4?S4 133 2s 37 74 u.b 4.0 8.0 22 is 'LL 0 rj-4LA Ica, 22;!5!i a. 00- kric ON 4NPI CNII WN w w g@ 0 w w WN w w ww N s@ w J. N 4w w w w CP w v w O(PO 000 00 L"-40 cow 07ur TV imp C I= z oz 0 mmm 0 awwno f ?7??Tf T?f.0??rTf a oaw ONO ?f ?7??f ff Tf T'Oorf7f7 ONO NO* Lr-jo a LPMWO p m Ln el IP W CP CP a N W w N w W w W ON Z 0 m0 0 N ON 6- 0 0 z r 1 xc c 30 0 rr.r m LM m m LA -C m a 0 4-d WNO%."aw CPCFIOmoo 0-40 dW-O--dw -41 @-410 'OO&OOO MW-4 04 30 r x 1. 0 1 Ic tff-i4 a ZV. w w cr.w #1 0 -W LPUIWN--D 0 N W ;R TABLE 16 Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon 0281CROO12 FC-143 in Rats Ranges of Urinalysis Values at 3 and 6 Months Specific Dose Group Gravity pH 3 Mo. Male Control 300 PPM 30 PPM 1.025-1.062 7-9 1.030-1.046 7-9 1.018-1.090 7-8 3 No. Femle Control 300 PPM 30 PPM 1.011-1.052 7-8 1.015-1.052 7-9 1.016-1.056 7-8 6 No. Male Control 300 PPM 30 PPM 1.021-1.066 6-8 1.022-1.054 7-8 1.018-1.070 6-8 6 No. Female Control 1.028-1.072 6-7 300 PPM 1.018-1.046 6-8 30 PPM 1.024-1.050 6-8 Albumin N-Tr N-I+ N-Tr N-I+ N-M N-N N-3+ N-Tr N-Tr N-3+ N-3+ N-Tr Bilirubin M-N N-N N-H N-N N-N N-N N-N N-N N-N N-N N-N N-N Glucose N-N M-N N-N N-N N-M N-N N-N N-N N-H N-N N-N N-N Occult Blood N-4+ N-N N-3+ N-N N-N N-N N-3+ N-I+ N-I+ N-I+ N-2+ N-Tr Code: N negative Tr trace 1+ - slight 2+ - slight to moderate 3+ - moderate 4+ - marked marked FO TABLE 16 Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon 0281CROO12 FC-143 in Rats Ranges of Urinalysis Values at 12 and 18 Months Done Group 12 Mo. Male Control 300 PPM 30 PPM 12 No. Female Control 300 PPM 30 PPf4 18 No. Male Control 300 PP14 30 PPM Is No. Fewle Control 300 PPf4 30 PP14 Specific Gravity 1.040-1.093 1.015-1.054 1.029-1.063 1.023-1.070 1.012-1.059 1.008-1.048 1.016-1.064 1.024-1.050 1.022-1.066 1.016-1.058 1.011-1.034 1.016-1.050 pH 7.0-8.5 7.0-8.5 7.5-8.5 6.5-7.5 6.5-9.0 6.5-7.5 6.5-8.0 7.0-8.5 6.5-8.0 7.0-7.5 6.5-8.0 6.0-7.5 Albumin M-4+ N-3+ N-4+ N-3+ N-3+ N-2+ N-3+ N-4+ N-4+ N-3+ N-2+ N-3+ Bilirubin M-N N-H N-N N-N N-N N-N N-N N-N N-N N-N N-N N-N Glucose M-M N-N N-N N-N N-N N-N N-N N-N N-N N-N N-N N-Tr Occult Blood M-3+ N-Tr N-3+ N-N N-2+ N-2+ N-2+ N-N N-3+ N-Tr N-Tr N-4+ Code: N negative Tr trace 1+ - slight 2+ - slight to moderate 3+ - moderate 4+ - marked to marked TABLE 16 Two Year Oral (DLet) ToxLcLty-oncogenicity Study of Fluorocarbon 0281CROO12 FC-143 in Rats Ranges of UrLnalysis Values at 24 Months Dose Group 24 No. Male Control 300 PPM 30 PPM 24 Mo. Fewle Control 300 PPM 30 PPM Specific Gravity 1.018-1.054 1.023-1.043 1.018-1.056 1.012-1.034 1.009-1.037 1.014-1.030 pH 6.5-8.5 6.5-8.5 6.0-8.0 7.0-8.5 5.0-8.0 7.0-8.0 Albumin N-4+ N-4+ M-4+ N-2+ N-2+ N-I+ Bilirubin N-N N-N N-N N-N N-N Glucose N-N N-H N-N N-N N-N N-N Occult Blood K H-4+ N N-N N N-4+ N N-N N N-N N N-4+ N Code: N negative Tr trace 1+ - slight 2+ - slight to moderate 3+ - moderate 4+ - marked to marked co TABLE 17 TWO YEAR ORAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FC-143 IN RATS ABSOLUTE AND RELATIVE MEAN ORGAN WEIGHTS ONE YEAR INTERIM ABSOLUTE ORGAN WEIGHTS (GRAMS) 0 PPM 300 PPM MALE N 15 N a 15 ORGAN WT SD WT so ------------------------------------------------ BODY LIVER HEART SPLEEN KIDNEYS ADRENALS TESTES BRAIN PITUITARY 625.5*-6S.905 lg.IS+- 3.212 1.629+- 0.157 0.894+- 0.144 3.BS4+- O.SO7 .0679+- 0.013 3.SS3+- 0.419 2.113+- 0.111 .0205+- 0.006 580.8+-SI.IS3 21.33+- 2.497 1.4S2+- 0.053* 0.800+- 0.109 4.047+- 0.419 OSS3+- 0.008* 3.459+- 0.32S 2.064+- 0.067 OIIS+- 0.004* FEMALE N = IS N = 15 ----O-R-GA-N---------WT------S-D -------WT-------s-o---------- BODY LIVER HEART SPLEEN KIDNEYS ABRENALS UTERUS BRAIN PITUITARY 401.1+-77.172 12.25+- 1.904 1.117+- 0.134 0.663+- 0.123 2.S33+- 0.383 .0761+- 0.012 0.77S*- 0.247 1.963+- 0.128 .0227+- 0.006 403.1+-66.702 12.90+- 1.781 1.086+- 0.121 0.613+- 0.120 2.S99+- 0.283 A .0796+- 0.019 0.702+- 0.221 1.970+- 0.119 .019S+- 0.007 n : P (z OS. TWO TAILEI)OUNNETT T ON RAW DATA. I : P <= .05. TWO TAILED DUNNETT T ON RANKED DATA. A : N = 14. TABLE 17 TWO YEAR ORAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FC-143 IN RATS ABSOLUTE AND RELATIVE MEAN ORGAN WEIGHTS ONE YEAR INTERIM ORGAN WEIGHTIDWY WEIGHT 0 PPM 300 PPM MALE N-;-15 ORGAN % so % so ------------------------------------------------ LIVER HEART SPLEEN 3.053+-0.318 0.262+-0.021 0.144*-0.025 3.6964-0.504* 0.252+-0.024 0.138+-0.018 KIDNEYS ,ADRENALS TESTES BRAIN 0.617+-O.OS7 0.011+-0.002 0.570+-0.057 0.340+-0.026 0.701+-0.090* 0.010+-0.001 0.598*-D.064 0.350+-0.029 PITUITARY 0.003+-0.001 0.002+-0.001* FEMALE OR(IAN LIVER HEART SPLEEN KIDNEYS ADRENALS. UTERUS BRAIN PITUITARY N a 15 % so 3.090+-0.293 0.284*-0.036 0.166+-0.031 0.642+-0.091 0.020+-O.OOS 0.201+-0.077 0.507*-O.ios 0.006+-0.002 N x 15 % so 3.239+-0.423 0.274+-0.040 0.156+-0.048 0.649+-0.111 A 0.020+-0.006 0.181+-0.074 0.499+-0.077 0.005+-0.002 n : P (s .05, TWO TAILED OUNNETT T ON RAW DATA. I : P .05, TWO TAILED DUNNETT T ON RANKED DATA. A : N 14. 00 !113 TABLE 17 TWO YEAR ORAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FC-143 IN PAT ABSOLUTE AND RELATIVE MEAN ORGAN WEIGHTS ONE YEAR INTERIM ORGAN WEIGHTIBRAIN WEIGHT (GRAMS) -0--PP-M------------3-0-0-P-P-M--------- MALE N a IS N - 15 ORGAN RATIO SD RATIO SD ------------------------------------------------ LIVER HEART SPLEEN KIDNEYS ADRENALS TESTES PITUITARY 9.049+-1.321 0.772+-0.071 0.424+-0.070 1.821+-0.192' 0.032+-0.006 1.676+-0.150 0.010+-0.003 10.339+-I.i87N 0.705+-0.036* 0.389+-0.056 1.964+-0.227 0.027+-0.004* 1.675+-0.129 0.005+-0.002* FEMALE N z IS N x 15 ORGAN RATIO SD RATIO so ----------------------------------------------- LIVER HEART SPLEEN KIDNEYS ABRENALS UTERUS PITUITARY 6.273+-I.Ooi 0.571+-0.073 0.337+-O.OS6 1.294+-0.197 0.039*-0.006 0.397+-0.130 0.012+-0.004 6.550+-0.826 0.552+-0.065 0.312+-0.064 1.323+-0.123A 0.041+-0.010 0.3S6+-O.Ili 0.010+-0.003 0 : p <2 .05 TWO TAILED OUNNETT T ON RAW DATA. I : P <= .05: TWO TAILED DUNNETT T ON RANKED DATA. A : N = 14. co @j TABLE 17 TWO YEAR ORAL 41)ILTITOXICITY-Ot4Co(iENICITY STUO)Y Of FLUOROCAR"ON FC-143 IN "ALF HATS ONE YEAR INTERIM INDIVii)UAL 046AN WEIGHTS OOSE AN114AL ROOV 0 PPM AIR-3516 ?20 0 PP" AIR-3SI? 6%1 0 PP$4 AIR-3S20 bss a ople AIN-3S22 62? 0 PP$4 AIR-3S2? 634 0 PP04 AIR-3S39 S94 I* ppm AIR-3S43 ?47 9 PP04 AIR-3S46 6S6 0 PP" AIR-3sso S66 a PPM AIR-3SSI 494 0 PP" AIR-3SS9 621 0 PP04 AIM-3S60 688 a pp" AIP-3S?O SYS 8 ppm AIR-3S?S ssi 0 PP" AIR-3SOO S90 300 ppla BIR-3SO4 S4? 300 PP" DIR-3SSR S64 3:: PP" SIR-3%49 SS2 3 PP04 84R-3S92 6S? 300 PPM "In-3s96 56S 300 PPM PIR-3604 S54 300 PPI'- RIP-3613 6d6 300 PP" RIP-361? SS2 300 PP$4 RIP-3620 641 300 PPM BIR-3622 401 300 PPM RIP-36?6 603 300 PPM BIR-362? s9s 300 PPM BIR-3638 SS9 300 PP" BIR-3642 S43 300 PP@4 AIR-3643 607 LIVER 23o"B 210?4 24*P? 16*10 160?1 lo*12 24096 lle6l ls.19 13096 19.S3 22031 l6eSS 19088 190?? 18OS6 25031 24*14 1606? 22o98 21.43 tole? 20*giO 22e9l 11088 2S*32 20094 20e'40 29o3b 22o3b HEAPT 10?86 loS6S 10?19 106?S l.bi? lo6s4 1.?03 Pools 11416 19361 1*536 1*629 10526 loh36 los56 1.4d? lebl6 IsSO6 10402 10448 1,503 1*3615 1,4"s 1.449 1.35? 103,OS 10481 10412 1*439 1.4119 SPLEFN loo?9 0.1074 0.??? 00?76 Oebba ago9s 0.904 009ort o.?04 00?Sl 0.41?2 10001 00491 1.113 1002" oobo3 00593 0.?94 Q."?n 0014? o,Hrp4 0991%3 00"?S O.Hraq 0.760 0*013 0.7is 09146 00"Al OOVSA f(fl)NYtS 3o9?0 4*043 4*3w)? 4.?Pl 3o3Sfj 3.4?4 49365 3 a 9rvm 396$ift 206%7 3*%4fl ##.6140 305?S 3 o?041 40170 A*04gi 4ogvA4 3.Rci? 3.br%g 4*396 40AP6 i.rlq3 :9091s *#Ongh 3944? 40%42 397"3 3*793 3oFIR6 40446 AF$WENALT-a V4 fift 42 by S? a? S4 ?? 41 S9 in 64 64 to? 76 43 63 ss bs 61 62 7(1 4" S9 61 41 47 47 44 43 NOTES: Body weights and organ weights in grams. indicates organ weights in mg. TESTES 3.??? 40147 3.96? 3.?,14 39316 3.230 3.?04 3.4bo 39,411 ?*SRI 3*331 3.870 3*9-03 2e944 3.40f% 3.i*?6 3.99S 3.?Do 3."39 3.264 3.724 3.316 3*604 3.4$4 2.?Qo 3920S 3.381 3oR22 30649 3*41A H"Alt 2.330 2.111 29204b 202? 2.Oh 1.4s OP.)9 i?o(If ie0 113 1.4i! 2*()? 20?0 2011 104*11 20011 .1.4"1 e.10 4?.D?f 2*lh ?.Oll I.Vom io.04 2OP3 2010 1*9%0 2*ob 2*12 Pol? 2*IP JOY3 OD TABLE 17 TWO YLA,4 ONAL IDIF-TI IOXICITY-IlhCI)44FNICITY StUnY OF FLI)4)ROC&Rt4ON tC-14#3 IN Ft$4ALL MATE, ONF YtAI4 iny@wim lNnIVIIIIIAL ORGAN UkiGhTS DOSE ANIMAL RODY LIVFR MFART SPLFFN R IIINF.YS AnocN&LS a IITERIIS HROIN I PPN MIR-4578 S48 0 Po" 3@S 0 pp" "IR-45ps 3S3 8 PP'4 NIR-4sme 3"6 0 ppm MIR-4sR9 3?S 0 pp" MIR-4s9o 3?3 0 PPM "IR-4601 470 0 pple MIR-4604 429 0 ppiq NIP-4610 34S 0 PPN MIR-4620 320 9 ppm "in-46?9 401 0 PPOO "10-4634 466 9 PP" HIR-4631 248 0 PPN NIR-4632 531 0 PP14 HIP-6640 39S 300 PPN OIR-4642 323 300 PPM OIR-46S2 383 309 PP04 OIR-46ss 312 300 ppm Oka-464;6 447 300 PP" OIR-666* 399 390 PP" OIR-4&64 319 300 PP" OIR-4669 3as 301 PP" OIR-4671 497 300 PPO 010-46?4 3%S 300 PP" OIR-46?6 519 300 PPO Ola-46"? 329 301 PPM OIP-46P9 363 309 PP14 010-469? S31 309 PP14 OIR-4699 39S 300 PPO* OIR-4?04 409 IS034 12026 12eqo 11699 13*19 1001)2 13*39 13*00 11*31 1104S llo33 13OP3 ?43? 14070 11969 10645 13,12 12.16 13,49 140?6 120?6 1?010 11 1f6? 13*r,9 14036 120%6 li.?Z 13OS4 11OS9 10*IR 1.390 loins loS3S loll? 1&995 1.031 10164 1.021 O*9ft2 leitto loON4 1*200 nesio 10128 1.23A 00920 1.11V 1.045 tolbo 1 0 lsto 10066 oo9s2 1*101 0.9?? 10?06 1910" 1.312 1.210 OOV"? n.943 Delsil 0041" 0*626 0.679 006t)i 0.5?1 fl*Rh" 0.644 0.0,Rl coyno 00663 Go??% 04414 oe??,l (1.731 00737 0.0ino Omfi43 00*0% O.hRf; OofIA 00614 notioll 11.594 00634 00"3? 0.794 0.4fkR a." I O.S?T 30779 ipe4os ?*P?3 Lo.ri3r, 3.14& P.3nm 3*lig) e.354 i?.41c, 2.470 2.116 20fili% lo"44 2@f#?o 2*Sl? 2*01?9 2.q?p 2oS?? 3*0?0 2. In ib ?.?Am 2o3q6 ?."%P P.74a 20"nm ab 20447 2.4RA e.IA4 4?.116? mo "I Sh (17 in ro 6? mr, A? 99 fis me 6? S9 9p ?h h4 71 TH Iri lnh %9 114 64 90 on lir, 40 in 0)4 a.fitih noq?o 0.0.14 n.#.s4 1.9.17 fi.q33 0.40? O.Q#13 1.171 o,ok#ji% n,c@73 n.sp" coli2a 0.0098 OOR13 lot%" ".Ihfl o.s4l O.A"m "*cis? n.Rhi 0.1%6 O.AIS 0.44A n.104 0.974 6,660 D.IS% oorom 0.3sn 4?0044 l.bT* 10911? 2.n?3 lo'4h3 I.ATS 1.92A 2.124 1 .9hol P.I.IS 1.4hl 7.11)4 1.043 1.14400 1.1-143 1.416% Z.?bs ].?40 2.011 1.44ft 1.460t 1014'3to 2.00to 2.009 ?.Oolq ?.O-o? j.hil 1.441 I.Iqjo 1 f.401 NOTES: Body weights and organ weig*hts in grams. a Indicates organ weights in mg. Kidney weights not recorded due to marked hydronephrosis. 00 TABLE 18 TWO YEAR ORAL (NIET) TOXICITY-ONCOriENICITY STuny OF FLUOROCARRON FC-143 IN RATS ARSOLUTF AND RFLATTVF MEAN ORGAN WEIGHTS AHSOLUTE ORGAN WFIGHT t(4PAMS) MALE 0 PPM ----------- N = IS 300 PPM ------------ N 15 3n PPM ----------- N m Ic; ORGAN ---------- RODY I.IVEP HEART SPLEEN KIDNEYS ANRENALS TESTES ARAIN WT so -----a-@----m-m 666t7+-99t761 18.154- 30074 ld?204- 06225 lo2lT*- 0%339 4*494+- *0841+- 3*478+- 06746 06018 06702 2.IOS*- Obl33 WT so WT sn ------a----- ----m --------------0---M" 632"'6*-91.947 19.;P*m 3.037 lo665*- Oo295 64R*?+-106696 IR*gl*- 3.427 1.806*- 0.313 1415A+- 0*310 445904- oes2s *0866*- 09019 3d6E6+- 0*643 Pol8c;*- OoO?2 I*IOS*- 5*ISS*- OQOO+3*696+2*203*- 0*206 I*TR2 0,027 O.T27 0*130* FEMALE N a 15 N z 15 N z jr3 ORGAN WT SD WT SD WT SD ---------------m---m ---------------0-------------- ---------f-tm-- RODY 4%1"2*-68*116 533*3*-82*486 LIVER 15.11+- 367S2 140;5*m 2.T35A 17906*- 3*847 HEART lo3G6+- Obl9g 1@3tC*- 9.170 lo4A9*- 0.192 SPLEEN Oo7974- 0&140 046494- 00195 1*153*- 096SIO KIDNEYS 3*1294- 0&287 3elSS*- 0*465 3*47S#- 0.446* ANNENALS .10104- 06046A .1126*- 0.039 .13654- Oo844 UTERTIS 0*814+- 0&290 0*8194- 0.391 0*058*- 0*487 ARAIN 2*034+- OuIO2 2e04q+- O.Itl 2.030*- 0.131 P <= BS9 TWO TAILED OUNNETT T ON RAW DATA' 00 P <= 059 Two TAILED DUNNETT T ON RANKED n;TA. ?I A t N = 14 ANIMALS* TABLE 18 TWO YEAR ORAL (DIET) TOXICITY-ONCOMENICTTY ABSOLUTE AND RFLATIVF STUDY OF FLUOROCARBON MEAN ORGAN WEIGHTS FC-143 IN RA MALE ORGAN LIVER HEART SPLEEN KIDNEYS ADRENALS TESTES BRAIN ORGAN WEIGHT/nony WFIGMT 0 PPM ----4 ---------- N :1 15 300 PPM ------- N = 15 30 PPM ----------- N = 19 so so -------m ------- ----------- E*7334-0.539 0*241+-0*037 0*167+-Oo$59 0-6664-0ol0l 0*012+-Oo$03 065364-0.144 0*3224-0*049 3dO43+mo*400 062674-OoOS4 0#184*-0*047 Oo736*-oolO9 OoOt4*-O*OO3 OoST8*-OoIOG Ov3S3*-O.OS4 sn --------m -------- 29934*-Oe%31 O.?83*-OoOSS 0.174+-0.042 0*9214--0*350 OsOI44-OoOOS 0.5744-0*093 0*347*-0.056 FEMALE N a 15 N = IS N a 115 OR6AN s ---------------- so 1! so 9 sn ----------------m----m ---------0----" LIVER HEART SPLEEN KIDNEYS ADRENALS UTERUS BRAIN R*941+-0.66S 09?694-Oe936 OiIS84-0*133 0*6214--O;IAO OoOaO+-0.408A odigl*-O.oss 0*4684-0-977 3olPS*mo*41TA Od296+-09056 Ool97*-ooO46 04709*-0%129* OOOES*-Ooolo 04183*-O*OT6 0*46rp+-0,079 30196*-0.550 0*283*-0.046 0.210*-O.OTB* 0*662*-0.102 0.026+-0.007 0.163*-0.092 0.389*-O.OS6 * iP .059 TWO TAILED OUNNETT T ON IRAW DATA.' co N IP 059 TWO TAILED NUNNFTT T ON RANKED DATA. @4 A : N 14 ANIMALS* TABLE 18 TWO YEAR ORAL (DIET) TOXICTTY-ONCOGENICITY STUDY OF FLUOROCARBON FC-143 TN R ASSOLI)TF AND RFLATIVF MEAN ORGAN WEIGHTS ORGAN WEIGHT/BRATN WEIGHT (GRAMSI 0 ppm ---------- 300 PPM -m4 --------- MALE N = 19 N = IS -m@.d-m ORGAN RATIO SD RATIO sr) -----m-----------i-m-mm---m-------A-m-------M.& ----mm LIVER 8*6484-1*587 8#T96*-lo424 HEART OeSI9*-0*103 Od76O*-0.119 SPLEEN KIDNEYS ADRENALS TE'STES 00578+-Ool%S 2oO99*-0*977 06038+-Ooelo I.6SR4-0.336 OeS314-0.144 2el0l+-O*232 00040+moooob 1@694*-09287 30 PPM N = 15 RATIO SD ---------m-8*S44+-1.495 0*821+-0.141 09501*-0.086 2*360*-0*827 0.041*-0.013 1.675+-n.?97 FEMALE ORGAN LIVER HEART SPLEEN KIDNEYS ADRENALS UTERUS N a Ic; N a 15 RATIO SD RATIO sn ------------4------- ------ 764S6*-1.918 0*6?3+oO.10n Oo3944-09078 1*5434-0,166 09050+-0*022A 0*4044-,0.156 6*883*-IbSOBA 0*642+-0*097 Oe343+-0.109 16545.*-0*259 00055*-Obolq Oa46O*-Ool73 N = 15 RATIO sr) -------- 8*460*-2.162 OoT38+-O.ll7 09568+-0.3254 19TI6+-0.231 0*068*-0.023 0.41Q*-n.?76 i P <= *059 TWO TAILED NUNNETT T ON RAW DATA'ol 00 : P <=-.O-rwg Two TAILED DUNNETT T ON RANKED DATA. ?D A I N n 14 ANIMALSO TABLE 18 IWO YLAR URAL io)it.11TUAICITY-ONC06ENICITY STUDY OF FLUONOCAKHON tC-14.1 IN P4ALE HATS TWO YEAR INIJIVinl)ALOHUAN WEIU"VS DOSE ANI"AL body LIVER HIEANT SPLftf4 itIo)NEYS - ADMENALS-A TESTTS "RAI 9 ppiq A103SIN SS6 IS012 1.623 1.31" 3o9l3 60 4.521 2.lii 0 PP14 AlR3S24 636 23.4S I.Sil 1.41S 4.04S si 3.91-1 ?.ON 9 PP$4 AIRISZR 612 19.6? 1.11#4 1.111 4.424 ol 4.082 ?.Ul 0 PP14 A103sli ?33 I?OS2 i.ft7i 0.070 joo42 7s 3.sr4 2.12 a PPOO AlAls33 765 IR.07 I.ti?S 0.941 o.128 ino 2.VY6 i!.O" a PPIO A103S3d led ielo?2 2.4ebt I.RVJ 4.j3S 94 3.ITH 2.14 a PP04 AIRIS42 133 11#60 l.b!26 41.128 4.233 S4 1.41H 2.20 a PPOO AlP3S40 706 16.44 1.661 1014d 4.b?Q 73 3.b.Jh ?.J;l a PPOI AIR3SS4 SIT l4ol9 j.h4? 1.13S 3*4b[ RH 3.t,2a 1.99 4 PO$4 AiP3SS? 612 17.71 1 . liff. l.lob if.lla To 4.1el ?. es 0 pp" AlR3S62 sea Is.14 I.fb16 1. rsfb 3.(Ouh 61 1.47S ?. afj 0 PP" AlR3s64 5?6 J6.20 1.67Y 1.396 J.14S 43 3.3e" 2.21, 0 PPIO AIRISBV 696 21044 2.172 i.r%sb 6.,bIa 10(i 3.if83 e.on 0 ppm AlN3S13 IS9 2P.41 I.faes novel S.011 113 3.561 l.fth 0 PP04 Ala3sis b21 13o%Z io%38 0.0400 j obei1 77 3.Olj 1 $"-, 300 PP#4 9lp3sRl 734 16042 1.786 1.2? 7 4.472 42 4.177 P.2h 309 PP'4 PIR3s8s 656 21.42 1.*#bs 1.447 ' 4.b4i 04 3.v4##$ 2ooT 300 PPM ItIR3S91 440 14.04 1.407 0.662 1*831 fi? 2*bJl i?ooq 300 PP$4 NIR3S94 174 23.R3 lo*#d6 1.231 5.013 76 3.vh? ?.21 309 PPOO "lp)s9? 634 14.,411 1 .!5"2 0.492 @b.032 97 4.0%11 2o 1.@ 300 PP04 RIA3601 643 21009 ?.SJO 1.8##1 h.bbe AV 3.vm.1 P.2? 300 ppm niolhos 6?6 P0.04 loSi!3 ft.qg#s 4.itso 42 Joe PP04 HIP3606 b06 Io.tsh I.3#ib 1.61*0 '#old? 04 P."hl 3.2,34 2.14 2.114 300 PP$4 AIR3611 641 10."3 i.b"2 1.320 4.271 In? 3.777 2.?#) 300 PP$4 HIP3618 eel IN.VT 1.514 oo7ilo 4.342 ?1 3."44 2.1? 30& PPM BIR3623 622 20.26 I.UI)3 1.211 S.oS? vi 3.@o*43 P.ie1 300 PP" BIR3&30 Sol IS.62 1 t#43 11.142% t*.utll 7 oi 3.tlR6 2.?l 300 PPM BIR3633 632 2##.fll I.hhfi I.Moll S.IZS 13,i 3.4)6 ?.11 300 PP04 PIR3&36 S64 16.44 i.b"S 1.067 4.222 fift 2.1184 2ei!4 380 PPM RIP36f#l 609 19.4s 2.UJZ 1.124 j.133 by 30 PPOI CIP1646 6ho im.li l.sov 1.04e 3.76A 6& 4.#*##4 3.144 2..e3 2.21 30 PP" CIR36so 586 lft-IT l.bos 1.417 *.1*? 44 f*.bd3 ?.41 3o PPM CI"3654 704 2l.ft4 ?.Oleo 1.10d Cl.309 03 S.311 ?.]I 30 PPN CIF43fiso 626 16.67 l.2v3 4.0431 #1. 1101 6(1 4*001 ?*Ib 30 PP04 CIR1663 711 2s.b6 2.172 1.17" It.fidi f4y 'I.IV04 P.4el 30 PPM CIR3667 Sol 17.03 j.hl2 0.47V 4.,%6? 704 3.30S 2.11 30 PP" 30 PPO CIR'1670 6S3 CIR3by2 616 19.03 16.11 P.010 1."2s 1.411 I.flh.2 1.1?d 4.4t.0 12fk 73 3.209i 2*41? P.?" 2.06 30 PP" CIP3676 b39 e4.00 2.3?6 1.414 IO.-ID4 143 I.?OV 2.1% 30 PPM CI"36?q 921 23*"b 2.leo O.Ybz 1).fthfs 40 405'b% ?.Jo 38 PP" CIP3662 545 16.02 1.%h4 41.905 4.147 64 3.umfo 1.101 30 ppm CIR3684 772 Ifi*Vo 2ollee l.lbi 'D.SSO 41 f#.IU4 ?.14 3o PPm CIR-4689 491 13.94 1 .0#16 1).11 @$ 4.1711 6;j 3. loh" ?.)I 30 PPM CIR3691 %9s lh."9 1.707 lo27l "1 3.14)? ?.t,4 co 30 PPM CIF43694 697 lfi.io I .to3 1 1.033 %.6?6 142 4.11,0 Ll.ol# to NOTES: Body weights and organ weights in grams. a Indicates adrenal weight in mg. I A B L E 18 TwO YTAR ()HAL 41)1@T) FOXICItY-ONCUUtNICITY STUDY OF FLUON(JCANDON tC-1%3 IN KENALE HATS TWO YLAN INI)IVIOUAL ONtiAN WLIUMTS DOSE AN104AL OODY LlVtN MT:ART '*PLETN %I I)NEYS AORE.NALS a UTERuh M.441 o PP14 6 PP" a PP" 0 PPM 0 Ppiq 0 PP14 0 ppm 0 PP" a ppm 0 PP" 8 ppm o ppm o PP04 a ppiq 0 pp" 36o PPm loo ppm 30o PPm 30a PPo4 308 PPM 300 PP04 309 PPo4 300 ppiq 300 pp#4 300 PP" 308 PPm 300 PPm 380 PPo4 300 ppiq 30o PPm 30 PPM 3o PPi4 NIR4SO3 NIA4586 WIR4r%Ol N104S9S U104598 NIR4603 NIA4606 14IR4611 NIR4&14 NIP4616 NIR4626 NIR4626 NIR4634 NIR4636 NIR4636 OIR4644 OIR4646 OIN4649 OIR46ST OIR4659 OIR4661 OIR4663 01040b?2 0104679 OIR4h83 OIN66dd OIR4693 OIR469S OIR4697 OIR4?01 PIR4706 PIR4711 494 4110 !i)6 4SS 4?1 481 so? b84 SIG 347 353 535 S6? 560 6?b 468 b39 378 416 S19 4s9 400 388 ssi 376 3?S 4RO 449 3S4 542 SP6 S%9 l5.y9 li.t$6 14.21 II.YO 13.45 14.37 14.9(0 24.ha 14.40 11.77 10.28 13.34 19.23 IY.S? 16.26 14ojs 17.04 11*32 14.1ba ls.ft4 12*22 14#01 10.92 21.3V 13.9t, 13.32 12.13 C- 11.60 13.9" 17.h3 22.66 1.114 1.?1!) 1.3?p 1.1#15 l.s38 1.46S 1.601 1.567 1.4ios l.,4s4 0.91#9 1.102 l.s23 1.180 1.612 1.208 lo;.jsm I.Osb 1.119 1.308 1.1,33 l.f#sz 1.403 I.b2l i.bis 1.334 l.id7 i.tio 1.122 1.288 1.37S 1.4S6 1.03le 0.483 0.?4*1 0.740 fi.Yal (1.657 ii.7b? 0.721 0.647 0.717 ii.Stil (1.938 U.66'j 0.933 41.60#1 O.94t6 0.445 0.677 1.131# O.t$30 ll.hbd 0.444 0.711 ft.941 O.-tS* 0,L)SI ll.1#71 11.72d (1.5"9 0.#iS? 1.016 3.3bd ?.824 3.lbl 2.ynb 3.4h6 3.210 3.374 3.318 3.356 3.012 e.464 3.0"2 2.874 3.261 3.390 2.012 3.6mg ie.806 2.044 3.i?43 2.348 3.2?b e.y3o 4.1et) 1.4%00 J. 1#43 -e.by2 3.137 e.937 3.IY4 3.8119 3.u"s 9" h3 84 10#1 b 144 114 2ci3 91 12? ?A 79 In" 8!) is ?h 89 38 131 102 64 13H 100 li.,A lil3 137 1?9 ITS 117 li? 173 123 O.li%i I.Ohli 0.8"4 0.7119 1 4 1LjLi 0.7?4 1.13yi 0.5his a.b?O 0.803 0.3t)4 n.812 0.73" 0.14h 0.6)h 0.4fth 0.7h7 0.511" O.Sqb 1.4hb 0.4e4 1.07h o.hbs 0.4"h (1.41H 1 .(Itio 0.,O.,h i.bj2 0.1103 0.5114 O.IP41) 0.!)17 ?.01 ?.Oh 1.1#h ?.Om I . #? ?.1? 1..#? ?.Il ?.0% 2.14 Z.O@4 l.y7 I.vi l.dy 2.21 IoLih ?.el ?.19 ?.04 ?.Ul ?.Oti ;@.oi3 1.101 J.44 ?.Oh ;,..Its ?.Oti ?..I"i I.Yi 1.4.1 1.*4? 1.9? 30 PP" PIN4714 54,S 23.6? I.bY3 1.027 3.yti4 20? (1.#..1? 1 oiL) 3o PPm PIN4716 404 10.44 I.SV4 11.4fiv 2.722 10% (1.40#4 1.1414 30 PP" PIR4720 b39 ly.79 1.411 1.246 3.rtia 114% 8.610 ?.Ol 3o PPm PIN4723 542 16.73 I.,#j2 1.0my 4.Uhb 118 2.4411 2.11, 30 PPm PIN4726 606 16.96 1.864 1.057 3.o7h 103 l.Uh4 ?.Il 30 PPM PIN4729 502 19.16 1.693 0..441 3.608 ihy 1.03!) 1."4 30 PPM PIR4733 452 1?.?? I.?Iy U.707 Yf# O.Mil ?.Ii) 30 ppm PIN4736 b33 13.07 I.JV4 11.4?0 i.21h 73 O.b,40 ?.On 30 PP14 P144739 756 22.13 1.7o#i J.561 3.113 ?10 0.1322 ?.41#4 30 PP04 PIR4?45 420 14.03 1.4h4 0.#Ii!4 J.670 III O.lp7ds ?.Oq 3o PPi4 PIR4747 545 16.57 1.274 1).9y 1 3. 1#117 1 i@@ ft.ti%b ?. JLI 30 PPM PIR4?')2 sis lgi.OY 1.51" ii.m%4 4.012 ihm D.tsh4 ?.In to 30 PPo4 PIR4754 4R7 14.BM 1.2111 1.1sr e. fig O.hl4 1. Yt, c@l NOTES: Body weights and organ weights in grams. a Indicates adrenal weights in mg. b Indicates adrenal weight not recorded; left adrenal greatly enlarged. Indicates liver weight not recorded due to mass. TABLE 19 Two Year oral (Diet) Toxicity - OncogenicityStudy of Fluorocarbon FC-143 in Rats Summary of Major Microscopic Findings - Percent Incidence at 2 Years Organ/Lesion n=1 Adrenal Pheochromocytoma, benign Pheochromocytoma, malig. Liver Hepatocellular Carcinoma Mammary Gland Adenocarcinoma Adenoma Carcinoma Fibroadenoma Lymphangiosarcoma Pituitary Adenoma Testes/Epididymis Leydig Cell Adenoma Thyroid C-cell Adenoma C-cell Carcinoma NEOPLASTIC LESIONS Controls Male Female 50 50 High Male Female 50 50 Low Male Female 50 50 4 4 8 0 8 0 0 0 0 2 2 0 6 0 10 2 2 0 - 15 - 7 - 2 - 22 - 0 - 11 - 31 - 0 - 0 - 0 - 0 - 48* - 42 - 2 - 0 35 72 28 72 36 83 0 - 14* - 4 - 0 2 9 0 5 0 0 0 4 0 0 0 1 - 50 rats/sex/groupwere at risk, % values derived from actual tissues examined - Significantlydifferent 0.05) from controls 91. TABLE 20 Two Year Oral (Diet) Toxicity - OncogenicityStudy of Fluorocarbon FC-143 in Rats Summary of Major Microscopic Findings - Percent Incidence at 2 Years NON-NEOPLASTIC LESIONS Organ/Lesion n=1 Controls Male Female 50 50 Adrenal Nodular Hyperplasia Sinusoidal Ectasis Heart 4 0 22 84 Myocarditis, Chronic Liver 28 32 Cystoid Degeneration 8 0 HepatocellularAlt. Basophil. 4 16 Hyperplastic Nodule 0 2 Megalocytosis 0 0 Portal Mononuclear 74 38 Cell Infil. Necrosis Lung 6 10 Alveolar Macrophages 20 28 Hemorrhage 20 28 Perivas.Mono. Infil. 42 26 Vascular Mineralization 86 44 Pneumonia, Interstitial 32 14 Testis/Epididymis Tubular Atrophy 14 - Vascular Mineralization 0 - Ovary Cyst Tubular Hyperplasia Thyroid - 13 - 0 C-Cell Hyperplasia Uterus 2 0 Cystic Glands Pancreas - 14 Acinar Atrophy Salivary Gland 13 12 Sialadenitis,Chronic Spleen 2 2 Hemosiderosis 32 so - High Ka-le Female 50 50 18 2 32 82 34 20 56* 2 12 4 6 4 80* 16* 96* 38 10 4 62* 38 44* 38 14* 28 94 52 14 18 22 - 18* - 11 - 32* 2 7 - 10 22 9 30* 5 44 24* Low Male Female 50 50 2 6 26 86 36 io* 14 2 2 16 0 0 12 2 64 22 10 12 32 20 28 26 6* 4* 86 76* io* 6 20 - 6 - - 18 - 14* 13 2 - 24 20 12 27* 2 8* 6* 1 50 rats/sex/groupwere at risk, % values derived from actual tissues examined Significantlydifferent 0.05) from controls 92. TM YM OR& 70No5040So2M FIGURE I TQXM--ONCOGDiC" ST= OF FUJOWCAFWN FC-U BM WIMM (G)OF MJM !Ai 0 10 20 30 40 so 86 76 80 90 100 "0 StuclWyeak TM YM M& 7Wno- FIGURE 2 TOOUff-ONCOGD4= STM OF FWORMAFMN BM WWflS (G)OF FDAALB FC-U3 4ft- 30- no- i 100- o 0 10 20 30 40 50 16 -70 80 90 100 UO Study Week FIGURE 3 M YW ORAL M" 1UXM-ONCOGENKMY STUDY OF FLUOROCARBON FC-XI FDW cm4sLumm (G/*KGOF MEAN BODY woGHT) OF mALEs 50 0 l@ 20 iO 40 10 110 70 so 90 100 no StuclyWeek FIGURE 4 M YM OR& W TOXM-ONCOGENM SM OF FLLOROCAFEW FC-U3 IN FOW CMAAA"M OF BWY WM" OF RMALM so- so- soLLO. 0 0 im 20 30 40 50 60 70 80 90 100 "0 StLadWyeek TWO YEAR ORAL (DIET) TOXICITY / CARCINOGENICITY STUDY OF FLUOROCHEMICAL FC-143 IN RATS APPENDIX ITEMS 97 InternaClorespondence Appendix Item A CC: F. r@. - 220-2E-02 W. 0. McCorr..ck - 220-2E-02 rc: J. K. Sugg - 220-2E-02 F. A. Ubel, M.L. - 220-2E-02 CASE - R.ATKERLABORATORIES - 218-3S r,or-S. D. SORENSON - MED'L^@AL, I&ND. HYG. SERV. 220-2E-02 s,--,ec. Air Monitoring, Project 89003107 August 27, 1981 3m Suvnmary Air monitoring has been conducted In three animal treatment room used in fluorochemical studies. The purpose of the monitoring was to evaluate Possible airborne contaminants. The sample results indicate that fluorochemical any, were below detectable amounts. exposures, If A@'.rsampling was conducted rooms Used in the two year and FC-143. 1981. The study has in the three animal treatment animal feeding study'of PM-3924 been In PrOgre33 since April 21, Are& samples were collected in each of the several treatment rooms by meansiof either impinger3 with methanol media or SKCO 31llea gel sampling tubes. With one exception, samples were located on top of the animal rack3. The one exception was an air sampler located near the room air exhaust near the floor. The period3 sampled are judged representative of "Usual" or steady state conditions. The flow rate of the sample pumps was checked approximately every 30 minutes throughout the sampling period. ihe samples were analyzed by the Analtyical Section of the 3M Central Research Laboratory. This laboratory has full accreditation as an Industrial Hygiene Laboratory by the American Industrial Hygiene Association. 98 Appendix Item A M. T. Case -2- August 27, 1981 The sa-nple results Indicate that airborne concentrations of the test fluorochemicals, if any, were below detectable limits. On this basis, It 13 judged that cross contamination potent4.al by airborne means is unlikely. Please call of there are any questions. SDS:cr 99 APPENDIX ITEM A M. T. Casa -3- Sample Data Building 218-3 Project 089003107 August 7, 1981 Sample Ni,m r CC121-20 CCLBl-23 CCL81-21 ccLal-25 CCLal-22 CCIAl-24 Description D-340. Control Rom, top of rack. Sa as above D-332. rM-3924, dose Rom. Sampler an top of high dose rack. D-332. Sampler at rear room air e3d%aust about 18 inches above floor. D-336. rC-143, dose Rom. Sampler an top of high dose rack. Same as CCIMI-22, duplicate Sample using silica gel tube. Time 922-1225 922-1225 926-1236 lOSS-1236 925-1228 931-1228 August 27, 1981 Compound FM-3924 PC-143 PM-3924 FM-3924 Concentration, mg/m3 < 0.003 /,0.001 <0.003 0.02S FC-143 FC-143 /,o.ooi < 0.002 SAMPLING METHOD: PH-3924 SXC silica gel sampling tubes. FC-143 Mapincjer - mthanol. ANALYTICAL METHOD: PH-3924 FC-143 - gas chromtography, - derivatization; 9" detector. olectran capture detector. chromatography, electron capture ANALYTICAL REQUEST: #AS0248. 10 u InternaClorresporxhwm APPENDIX ITEM A To: L. J. Sibinaki From: J. D. Johnson Subject: Date: Analysis of Plasma Samples from Sentinel Rats with Two Year Tox Study-Rats (Riker Study No. October 7, 1985 Housed in Room 0281CROO12) I have attached the one page protocol attachment for the use of sentinal rats in Riker Study No. 0281CROO12. Theme samples were collected as described. On July 15, 1981, forty plasma samples (see attached) were transferred to V. Pothapragada (Dr. V) in Commercial Chemicals for analysis of organic fluorine. The results were sent back by Dr. V 8/24/81. All samples were less than on* part per million. From this, it can be concluded that there was no airborne fluorine present that was interfering with this study. These data are in SJG Notebook 56531, p 53. OL-10-@ James D@.J@Jsc cisoan ?ReseajrR@ec:s6earch cialist Riker Laboratories, Inc. 10 1 Appendix Item A Interncaolrrespondence cc: M.T. Case F.D. Griffith R.E. Ober w.1t. Pearlson R.A. Prokop To-. v. Pothapragada From: J.D. Johnson SU:4eM Dow: Analysis with Two July 15, of Plasma Samples from Sentinal Rats Year Tox Study Rats (Riker Study No. 1981 Housed in Room 0261 CR 0012). 3N, Forty plasma samples from sentinal rats are submitted for fluorine analysis. These samples include 5 male (IR 3861, IR 3862, IR 3663, IR 3864, and IR 3665) and 5 female (IR 4921, IR 4922, IR 4923, IR 4924, and IR 4925) which were s:acrificed before dosing was initiated. The other thirty plasma samples wore collected at 30 days after docing started. There are 5 rats of each sex from the control room, from the room in which study rats are receiving PC-143, and from the room in which study rats.ace receiving FM-3924. The numbers for these. rats are as follows: 5 male Control Room (IR 3866, IR 3867, IR 3868, IR 3869, IR 3870) 5 female Control Room (IR 4926, IR 4927, IR 4926, IR 4929, IR 4930) 5 male Fr.-143 Room (IR 3876, IR 3877, IR 3878, IR 3879, IR 3880) 5 female FC-143 Room (IR 4936, IR 4937, IR 3838, IR 3839, IR 3840) 5 male FM-3924 Room (In 3666,-IR 3887, In 3888, Ilt 3889, 111 3890) 5 female PH-3924 Pom (IR 4946, IR 4947, IR 4948, IR 4949, IR 4950) Pleas* got back to us with the data. It may be that interpretation of the results will lead to specific analysis or to analysis of tissue. on/sho 102 Appendix iteir B CCD ANALYTICAL REPORT 0213 TO From P. J. Colbert GLC Analysis of Subic-:I into Ground Lab 236-2B FF,-3924 (T-2999CoC) Chow. (Riker Study FC-143 (T-299BCoC) #0281CROO12) Daie April 29, 1981 Blended 3 Rellerence: Commercial Chemicals Analytical Requests #17079, 17080, 17096 Laboratory Commercial Chemicals Analytical Method f's G30-0481 . G31-0481 Laboratory e samples of FV,-3924 (W.R. ETFOSE) blended into Groun Lab , along with four blank Ground Lab Chow samples, re c All rece ed from L. J. Sibinski on 4-20-81 for analys' sample were run in triplicate. The results are Compound Blank for concen te FY,-3924 Concentrate (blended 4-17-81 ) FV,-3924 Top Sample Mid Sample Theoretical 200 100 100 Actual ppm ug/g FM-3924 0 214 105 105 Botto ample 10 111 FM-3924 Sample 30 29 Mid Sample 30 27 Bottom Sample 30 30 FM-3924 Top Sample 10 Mid Sample 10 Bottom Sample 10 11 9 /0 103 APPENDIX ITEM B L. J. Sibinski CCD Analytical Report April 29, 1981 Page 2 #213 Co d Theoretical opm Actual ppm (ug/g)F Blank for 100 ppm lev 0 0 Blank for 30 ppm level 0 Blank for 1l0u vel 0 evel of ethanol in FM,3924 Concentrate (blended 4- was also checked and found to be less than I p;xn(ug/g). Six samples of FC-143 blended into Ground Lab Chow, along with two blank Ground Lab Chow samples were received from L. J. Sibinski on 4/20/-Blfor analysis. All samples were run in triplicate. The results are: Compound Theoretical ppii Actual ppm (ug/g)FC-143 FC-143 Top Sample 300 326 Mid Sample 300 282 Bottom Sample 300 297 Blank for 300 ppm level 0 0 FC-143 Top Sample 30 24 Mid Sample 30 23 Bottom Sample 30 28 Blank for 30 p;xnlevel 0 0 Because two of the three 30 ppm level samples were low, another' set of samples were received from L. J. Sibinski on 4/27/81 for analysis. The results are: 104 APPENDIX ITEM B L. J. Sibinski CCD Analytical Report #213 April 29, 1981 Page 3 Compound FC-143 Top Sample Mid Sample Bottom Sample .Blank for 30 ppm Ievel Theoretical pET 30 30 30 LJS/mao cc: M. T. Case - 218-2 E. G. Lamprecht - 2.18-3 W. C. McCormick - 220-2E-02 J. D. LaZerte 236-lL R. A. Prokop 236-2B V. Pothapragada 236-3A Actual ppm (ug/g) FC-143 31, 28 30 0 105 APPENDIX ITEM B InternaClorrespondence dc: M. T. Case E. G. Laniprecht J. D. LaZerte W. C. McCormick V. Pothapragada R. A. Prokop L. D. Winter 218-2 218-3 236-1 220-2E-02 236-3A 236-2B 236-2B Coiiuji(@rcCilaileiiticils Analytical Report ;229 To L. J. Sibinski 218-3-3 From. P. J. Colbert 236-2B SuOject: GLC Analysis of FM-3924 (T-2999 CoC) FC-143 (T-2998 CoC) Blended Into Ground Lab Chow (Riker Study #0281CROO12) Daic. June 15, 1981 Six samples of FC-143 blended into Ground Lab Chow, along with two blank Ground Lab Chow samples,were received from L. J. Sibinski on 5-18-81 for analysis. All sampleswere run in triplicate. The resultsare: Sample Theoretical ppm Actual ppm g_q/g FC-143 Blank for 300 ppm 0 0 FC-143 Top 300 303 Mid 300 305 Bottom 300 295 Blank for 30 ppm 0 0 FC-143 Top 30 31 Mid 30 31 Bottom 30 29' The next set of Ground Lab Chow Samples will be submitted for analysison August 17, 1981. PJC:da 106 APPEQDIX ITEM B Commercial Chemicals Analytical Report 0250 To- L. J. Sibinski - 21.'@-3-3 From P. J. Colbert 236-2B Subic,cl GLC Analysis of FC-143 (T-2993CoC) Blended into Ground Lab Chow (Riker Study 00281CROO12) August 20, 1981 Reference: Commercial Chemicals Analytical Laboratory trequest 017449, and CCD Method G31-0481 Six samples of FC-143 blended into Ground Lab Chow, along with two Blank Ground Lab Chow samples, were received from L. J. Sibinski on August 17, 1981, for analysis. All samples were run in triplicate. The resultsare: Actual ppm Sample Theoretical ppm ug/g FC-143 Blank for 300 ppm 0 FC-143 Top 300 Mid 300 Bottom 300 0 308 310 ,F"-'/ 328 Blank for 30 pprn 0 0 FC-143 Top 30 28 Mid 30 30 Bottom 30 30 PJC/mao dc: M. T. Case 218-2 E. G. Lamprecht - 218-3 J. 0. LaZerte - 236-IL W. C. McComick - 220-2E-02 V. Pothapragada - 236-3A R. A. Prokop - 236-2B L. D. Winter- 236-28 R. M. Payfer - 236-2B G. W. Kirsch - 236-3A 107 InternalCorrespondence APPENDIX ITEM B COMMERCIAL ANALYTICAL CHEMICALS REPORT #289 To: L. J. SIBINSKI - 218-3-3 From: R. M. PAYFER - 236-2B Sub)ect LAB Date. C;LC ANALYSIS OF FC-143 (T-2998 CHOW (RIKER STUDY #208lcRO012) November 30, 1981 COC)BLENDED INTO GROUND 3M References: Commercial Chemicals Request #17779 Analytical Laboratory Six samples of FC-143 blended into ground lab chow, along with two blank ground lab chow samples, were received from L. J. Sibinski on November 16, 1981 for analysis. All samples were run in triplicate with the following results: Sample Theoretical PPM Actual PPM ug/g FC-143 Blank for 300 0 PPM FC-143 Top 300 Middle 300 Bottom 300 0 278 .4. 310 323 Blank for 30 PPM 0 0 FC-143 Top 30 29 Middle 30 28 Bottom 30 33 RMP/he d= dc: M. T. Case -2 G. W. Kirsch 236-3A E. G. Lamprecht - 218-3 J. D. LaZerte - 236-1 W. C. McCormick - 220-2ET02 V. Pothapragada- 236-3A R. A. Prokop - 236-28 L. D. Winter - 236-2B (2 copies) 108 APPENDIX ITEM B InternaClormspondencx- dc: M.T. Case - 21@-2 G.W. Kirsch E.G. Lamprechi - 2"";-3 J.D. LaZerte - @3f-*, W.C. McCormick - 22,--2E-02 V. Pothapragada - 236-3A L.D. Winter - 236-23 To: L. J. SIBINSKI - 218-3-3 COMMERCIAL CHEMICALS ANALYTICAL REPORT #319 From R. M. PAYFER - 236-28 subiect:GLC ANALYSIS OF FC-143 (T-2998 CoC) BLENDED INTO GROUND LAB CHOW (RIKER STUDY #2081 CR 0012) Date. MARCH 5, 1982 Reference: Comercial Chemicals Analytical Laboratory Request #18069 Six samples of FC-143 blended into ground lab chow, along with two blank ground lab chow samples, were received from L. J. Sibinski on February 15, 1982. These samples were analyzed in triplicate for FC-143 with the followingresults: Sample Theoretical PPM Actual PPM ug/g FC-143 Blank for 300 PPM 0 300 PPM Top 300 300 PPM Middle 300 300 PPM Bottom 300 Blank for 30 PPM 0 30 PPM Top 30 30 PPM Middle 30 30 PPM Bottom 30 0 0( 16 5 215 215 0 27 33 .24 , 4z,ol@14111@ rep RMP:df 109 lnterrkCaolrresponderice APPENDIX ITEM B COMMERCIAL CHEMICALS ANALYTICAL REPORT #328 To: I.. J. SIBINSKI 218-3-3 From: Subject: Date: R. M. PAYFER - 236-2B GLC RE-ANALYSIS OF FC-143 (T-2998 CDC) BLENDED INTO GROUND LAB CHOW (RIKER STUDY #2081 CROO12) March 31, 1982 Reference: Commercial CHemicals Analytical Laboratory Request #18100 Three samples of FC-143 blended into ground lab chow, along with one blank ground lab chow sample, were received from L. J. Sibinski on March 8, 1982. These samples were analyzed in triplicate for FC-143 with the following results: Sample Theoretical PPM Actual PPM ug/g FC-143 Blank for 300 PPM 0 0 300 PPM Top 300 278 300 PPM Middle 300 283 300 PPM Bo om 300 284 RMP/hc cc: M. T. Case - 218-2 G. W. Kirsch - 236-3A E. G. Lamprecht - 218-3 J. D. LaZerte - 236-1 W. C. McCormick - 220-2E-02 V. Pothapragada - 236-3A L. 0. Winter - 236-2B internalCorrespondence APPENDIX ITEM B COMMERCIAL CHEMICALS ANALTYICAL REPORT #340 It] CL. 4. SliilkSKI 216-3-3 From R. M. PAYFER - 236-2B GLC ANALYSIS OF FC-143 (T-2998 Coc) BLENDED INTO GROUND LAS CHOW (RIKER STUDY #0281 CROO12) May 28, 1982 Reference: CormiiercialCheinicals Analytical Laboratory Request #18320 Six samples of FC-143 blended into ground lab chow, along with two blank ground lab chow samples, were. received froin L. J. Sibinski on May 17, 1982. These samples were analyzed in triplicate for FC-143 with the following results: Sample Theoretical PPM Actual PPM ug/g FC-143 Blank for 300 PPM 300 PPM Top 300 PPM Middle 300 PPM Bottom Blank for 30 PPM 30 PPM Top 30 PPM Middle 30 PPM Bottom 0 0 300 310 300 280 300 289 0 0 30 31 30 33 4 30 33 R il'h' dc: M . T. Case - 218-2 G . W. Kirsch - 236-GB E. G. Lamprecht - 218-3 J. 0. LaZerte - 236-1 W. C. McCormick - 220-2E-D2 V. Pothapragada - 236-GB L. 0. Winter - 236-2B APPENDIX ITEM 3 TO Frorn Subject Date COMMERCIAL CHEMICALS ANALTYICAL REPORT 0366 L. J. SIBINSKI 218-3-3 R. M. PAYFER - 236-2B GLC ANALYSIS OF FC-143 (T-2998 Coc) BLENDED INTO GROUND LAB CHOW (RIKER STUDY #0281 CROO12) Sept. 13, 1982 Reference: Commercial Chemicals Analytical Laboratory Request 018609 Six samples of FC-143 blended into ground lab chow, along with two blank ground lab chow samples, were received from L. J. Sibinski on Aug. 16, 1982. These samples were analyzed in triplicate for FC-143 with the following results: Sample Theoretical PPM Actual PPM ug/g FC-143 Blank for 300 PPM 300 PPM Top 300 PPM Middle 300 PPM Bottom Blank for 30 PPM 30 PPM Top 30 PPM Middle 30 PPM Bott I 4j-.eA@ f RMP/hc 0 0 300 300 300 319 300 304 0 0 30 29.5 30 35 30 29.5 dc: M. T. Case - 218-2 G. W. Kirsch - 236-GB E. G. Lamprecht - 218-3 J. D. LaZerte - 236-1 W. C. McCormick - 220-2E-02 V. Pothapragada - 236-GS L. D. Winter - 236-2B 112 InternCaolrrespondence APPENDIX ITEM B To tJ. L. Sibinski - 218-3 Frorn. G. W. Kirsch - 236-2B Commercial Chemicals Analytical Report #384 subject: GLC Analysis of FC-143 (T-2998 COC) Blended Lab Chow (Riker Study#0281CROO12) Date: December 8, 1982 into Ground 3M Reference: Commercial Chemicals Request #18855. Analytical Laboratory Six samples of FC-143 blended into ground lab chow, along with two blank ground lab chow samples, were received from L. J. Sibinski on December 5, 1982. These samples were analyzed In triplicate for FC-143 with the following results: Sample Theoretical ppm Actual ppm )jg/g FC-143 Blank for 300 ppm 300 ppm Top 300 ppm Middle 300 ppm Bottom Blank for 30 ppm 30 ppm Top 30 ppm Middle 30 ppm Bottom 0 300 300 300 0 30 30 30 0 323--, 292 L) 303 0 28 32 32 GWK:ch cc: M. T. Case - 218-2 E. G. Lamprecht - 218-3 J. D. LaZ*rto - 236-IL W. C. McCormlck - 220-2E R. M. Payfor - 236-2S V. Prothapragada - 236-GB L. 0. Winter - 236-28 13 InternaClorrespondence APPENDIX ITEM B - To: SllIlNSKI -z"218-3 Commercial Chemicals Analytical Report #395 From: G. W. KIRSCH - 236-2B SLOtect, Date@ GLC ANALYSIS OF FC-143 (T-2998 CoC) BLENDED INTO GROUND RODENT CHOW (RIKER STUDY #0281-CROO12) MARCH 7, 1983 Reference: Commercial Chemicals Analytical Laboratory Request #19121 Six samples of FC-143 blended into ground lab chow, along with two blank ground lab chow samples, were received from L. J. Sibinski on February 16, 1983. These samples were analyzed in triplicate for FC-143 with the following results: Sample Theoretical ppm Actual ppm ug/g FC-143 Blank for 300 ppm 0 0 300 ppm Top 300 317 300 ppm Middle 300 286 300 ppm Bottom 300 323 Blank for 30 ppm 0 0 30 ppm Top 30 32 30 ppm Middle 30 30 30 ppm Bottom 30 31 GWK/hc dc: M. T. Case - 218-2 E. G. Lamprechts - 218-3 J. D. LaZerte - 236-1 W. C. McCormick - 220-2E R. M. Payfer - 236-28 W. H. Pearlson - 223-6SE L. D. Winter - 236-2B 1 14 InternCaolrrespondence APPENDIX ITEM B Commercial Chemicals Analytical Report #404 To J. SIBINSKI 218-3 Frorn G. W. KIRSCH - 236-2B Sut)lect@ GLC ANALYSIS OF FC-143 (T-2998 CoC) BLENDED INTO GROUND RODENT CHOW (RIKER STUDY #0281-CROO12) MY Date MAY 2, 1983 Reference: Commercial Chemicals Analytical Laboratory Request #19333 Six sainplesof FC-143 blended -into ground rat chow, along with two blank ground rat chow samples, were received from L. J. Sibinski on April 13, 1983. All samples were analyzed in triplicate for FC-143 with the following results: Sample Theoretical ppm Actual ppm ug/g FC-143 Blank for 300 ppm 0 300 ppm Top 300 300 ppm Middle 300 300 ppm Bottom 300 Blank for 30 ppm 0 30 ppm Top 30 30 ppm Middle 30 30 ppm Bottom 30 0 326 331 328 0 33,.., 34 32 GWK/hc dc: M. T. Case - 218-2 J. D. LaZerte - 236-1 W. C. McCormick - 220-2E R. M. Payfer 236-2B W. H. Pearlson - 223-6SE L. 0. Winter - 236-2B 1 15 Appendix Item C Two Year oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FC-143 in Rats Normal Ranges for Hematologic -and Blood Chemistry Values of Rats at RLker LaboratorL*s, Inc., St. Paul, MN Erythrocytes Hemoglobin Hematocrit Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Laukocytes Neutrophils 2-22% Lymphocytes 65-95% Monocytes 0-5% EosinophLin 0-6% Blood Ursa Nitrogen (BUN) Glucose Total Bilirubin Total Protein Albumin Calcium Alanine Aminotransforame (ALT) Aspartate Am:Lnotransforane (AST) Alkaline Phosphatase Creatine PhosphokLnase (CPK) 5,000,000-8,000,000 cello/cu mm 11-17 g/dl 36-52% 57-77 microns3 18-24 picograms 30-34% 6,000-15,000 cells/cu mm 500-4,000 cells/cu mm 5,000-14,000 cells/cu mm 0-500 cells/cu mm 0-500 calls/cu mm 10-30 mg/dl 120-160 mg/dl 0.1-1.0 mg/di 5.5-7.5 g/dl 3.5-5.5 g/dl 10.2-12.5 mg/di 10-40 International Units/i 20-60 International UnLts/i 50-200 international UnLts/i 50-150 International Units/I 116 Appendix item c methods Used for Hematology On Bleedings at 3 and 6 Months Parameters Units Methods Hematology Total Erythrocytes Leukocytes Hemoglobin Rematocrit Differential cells/cubic mm g/dl % packed cells %/100 WBC Coulter Counter Model FN Coulter Electronics Hemoglobinometer, Model 231, Instrumentation Laboratories microhematocrit Centrifuge, Model MB International Equipment Co. Microscope slide 117 APPENDIX ITEM C METHODSUSED FOR HEMATOLOGYDETERMINATIONSFOR 12, 18 AND 24 MONTHS METHODSUSED FOR CLINICAL-CHEMISTRDYETERMINATIONSFOR 3, 6, 12, IS AND 24 MONTHS Parameters Hematology Erythrocytes Leukocytes Hemoglobin Hematocrit Differential Chemistry Total Bilirubin, Glucose Blood Urea Nitrogen Albumin, Total Protein Alkaline Phosphatase AST, ALT, CPK Urinalysis Specific Gravity pH, Albumin, Bilirubin, Glucose, Occult Blood and Ketones Units cells(106/Mmm 3 3 3) cells(10 m g/dl % %/100 WBC mg/dl g/dl International Units/I Methods and Techniaues UltraLogic 800 Hematology Analyzer Clay Adams, Division of Becton, Dickinson & Co. Microscope slide Rotochem 36 IIA Travenol Laborataories,Inc. TS Meter, AO Instrument Co. BiliLabstix Ames Company 1 18 APPENDIX ITEM D PATHOLOGY REPORT OF RATS RECEIVING FLUOROCHEMICAL FC-143 IN DIET FOR TWO YEARS 1 19 MMODS Gross Pathology All rats which were sacrificed at the 1 year interim or the 2 year terminal sacrifice or which died or were sacrificed in extremis during the course of study were necropsied. At necropsy, an examination was made of the external body surface and body orifices. The carcass was then opened and the contents of the abdomea, thorax and cranium were examined in situ and after removal frnn the carcass. Representative tissues and organs from each rat were fixed in ln@l., bi)fferedneutll formali-n for subsealienthistologic processing. At the 1 and ^ yep.r sacri-lices, t,,etweights were obtained on adrepals, brain, testes, heart,- kidneys, liver, spleen and uterus from 15 randomly selected rats/sex/group. Body weight=; were obtained prior to necropsv from the same rats for calculati.or. of relative organ weights. HiStODathr@logy Microscopic examination was made of hematoxylin and eosin stained paraffin tissue sections of the following tissues and organs, where available, from all rats from the contrel group (0 ppm)'and the 300 ppm groiipwhich were sacrificed at 1 a-id2 years or which died or were sacrificed in extremis during the coil,-.qe of study. aorta adrenals (2) brain (3 sections including frontal cortex and basal ganglia, parietal cortex and thalamus: cerebellim and po-.is) eyes gc-iads ovaries (2) testes/epidi-dynides (2) heart small intestine (3 sections) large intestine kidneys (2 sections) liver (2 sections) lung (2 sections) lvmdh node (mesenteric) m@m'mary gland (females) pancreas pituitary salivary gland spinal cord/bone marrow (vertebrae) spleen stomach thyroid/parathyroid/trachea/esophagus urinary bladder uterus or prostate any tissue masses (suspected tumors) any other gross lesions Microscopic examination of tissues from the 30 ppr.group included all the above listed tissues except aorta, brain, eyes, small and large intestine, lymph node and spirial cord/bone marrow. 0281CROO12 (FC-143) 120 RESULTS Gross Pathologv There were no gross f4-ndingssuggestive of a compound effect in anv rats from the 3nO ppm group which were sacrif-icedat the 1 year interim. At the 2 year termina'4sacrifice and-in rats i-7hich-dieodr were sacrificed in extremis during the cour-seof study (TS/DOS), possible compound related lesio-.Iisncluded an increased incidence of masses, nodules or raised lesions in the liver, an increased i-ncidenceTf yello-,o.r, pale liver foci or lesio.-Iasnd an i-icreased incidence of mottled livers and testicular masses in male rats from the 300 ppm group. There were no findings suggestive of a compound effect in TS/DOS female rats from the 300 or 30 ppm groups or in male rats "rom the 30 ppm group. Other gross pathologic findings were typical of findings in ageing rats of this strain. These included mammary masses, pituitary foci and masses, ulcers on the hind @4ootpads,pale 14-versand pale, pitted and enlarged kidneye. Organ Weights There were statisticallysignificant (p 0.05) variations in absolute and relative wfights (oroan:body or organ:brain weight ratios) of a niimberof organs in 300 ppm group male rats sacrificed at the 1 year interim. Except for an incrers,@in the liver:body weight ratio, these variations were not conpidered tox4-cologicallysignificant. The increase in liver:bodyt,7eighrtatio correlated li%i-tchompound related morphologic liver changes. The mran absolute li'Ter we;-ghtand the liver:brain weight ratio in these rats also were increased but not to a statisticallysignificantdedree. There 7ereno stal--isticallsyignific-int variations in organ weights in 300 ppm females sacrificed at the 1 year interim. None of the several statistically significant organ weight variations in rats sacrificed at the 2 year termination occurred in target organs or showed a dose response; noie was considered toxicologically significant. Histopathology Compound related microscopic changes were observed in the liver of male rats from the 300 ppm group at the 1 year interim sacrifice and in liver of male and female TS/DOS rats at both the 300 and 30 ppm levels. The principal compound related liver change was megalocytosis. which was characterized by an increase in size of liver parenchymal cells due to increased cytoplasmic volume. The increased cytoplasm was of a finely granular "ground glass" appearance. The coarser cytoplasmic organelles were relatively decreased and were displaced 0281CROO12 (FC-143) -2- 121 to the cell membrane. The nucleus:cytoplasm ratio was decreased by the increase in cytoplasm in affected cells. In affected livers, most or all lobules were involved and the centrilobular cells were more severely affected. At the I year interim, megalocytosis occurred to a minimal to moderate degree in 12/15 males from the 300 ppm group. No females were affected at the I year interim. In TS/DOS rats, mecalocytosis to a minimal to moderate degree occurred in 40/50 males at the 300 ppm level and to a minimal to mild degree in 8/50 females at the same level. At the 30 ppm level in TS/DGS rats, megalocytosis to a mimimal degree occurred in 6/50 males and in 1/50 females. In more maritedlyinvolved livers, the megalocytic hepatocytes were frequently vacuolated with multinle small spherical cytoplasmic vacuoles which in life probably contained lipid. Livers which had appreciable involvement with megalocytosis and cytoplasmic vacuolation also commonly had focal areas of necrosis. This association of hepatocyte vacuolation and necrosis with megalocytosis suggests that the progression of lesions is megalocytosis to fatty degeneration to necrosis. Incidence of hyperplastic nodules was also increased at 300 ppm, ind@.catingregeneration also occurred. The association of hepatocyte vacuolation and focal necrosis with megalocytosis was more clear-cut at the 1 year interim than in TS/DOS rats because of the normally higher background incidence of the former in older rats. Cystoid degeneration, characterized by areas of multilocular microcysts in the liver parenchyma, also was increased in male TS/DOS rats from the 300 ppm group. Incidence of this lesion was 4/50, 25/50 and 7/50.in the 0, 300 and 30 ppm males, respectively. The increased incidence of cystoid degeneration, megalocytosis and portal mononuclear cell infiltration in the 300 ppm dosage group was statistically significant at the 5% level in male rats. In females from the 300 ppm level, only the increased incidence of megalocytosis was statisticallysignificant. Occurrence of these histomorphologic changes in the liver correlates with. elevation of alkaline phosphatase, aspartate aminotransferase and alanine aminotransferase levels observed in male rats. The markedly reduced incidence and severity of histomorphologic liver changes in females parallels the absence of alterations in liver specific serum biochemical values in females. There was no direct or indirect compound effect in tissues other than liver at the 1 year interim sacrifice. In TS/DOS rats, changes which were considered secondarily compound related, probably through to FC-143 altered liver metabolism of endogenous steroids, were observed in the adrenals, ovaries and 0281CROO12 (FC-143) -3- 122 testes. In the adrenals, an increased incidence of nodalar hyperplasia of the cortex occurred in males at the 300 ppm level. Incideice of this finding in males was 2/49, 9/50 and 1/50 in 0, 300 and 30 ppm males, respectively. The increased incidence of nodular hyperplasia in males at the 300 ppm level was not statistically significant, however.- In females, tubular hyperplasia of the ovarian stroma occurred in-0/48, 15/47 and 7/50 rats from the 0, 300 and 30 ppm groups, respectively. This incidence was statistically significant at both the 300 and 30 ppm levels. Tubular hyperplasia of the stroma was a non-neoplastic dif.4use increase in tubular elements of the ovarian stroma which was usually bilateral and associated with absent or markedly reduced follicular development. In male rats, there was a statistically significant, compound related occurrence of benign Leydig cell tumors of the testes at the 300 ppm level. Incidence of Leydig cell tumors was 0/49, 7/50 and 2/50 at the 0, 300 and 30 ppm levels, respectively. Although occurence of 2 Leydig cell tumors at 30 ppm is also suggestive of a compound effect, these neoplasms are not uncommon in untreated rats, although none were found in control rats from this studv. The occurence of Leydig cell tumors correlated with the observations of testicular masses at necrODSY. Testes which contained Leydig cell tumors were usually totally aspermic. Mineralization of vessels within the testes occurred in 0/49, 9/50 and 3/50 rats from the 0, 300 and 30 ppm groups respectively. The increased incidence of testicular vascular mineralization at 300 ppm was statistically significant. In female rats, there was a statistically significant increased incidence in mammary fibroadenomas at the 300 ppm level. Incidence of this tumor was 10/46, 21/44 and 19/45 at the 0, 300 and 30 ppm levels, respectively. An increased incidence of focal accumulations of foamy alveolar macrophages occurred in the lungs of males from the 300 and 30 ppm groups. The incidence of this finding was 10/50, 31/50 and 16/50 at the 0, 300 and 30 ppm levels respecitively. The increased incidence of alveolar macrophages at 300 ppm was statistically significant. In females, the incidence of 14/50, 19/50 and 10/50 at the 0, 300 and 30 ppm levels did not have a statistically significant increase in treated animals. Other microscopic lesions in tissues from FC-143 treated rats were typical of naturally occurring inflammatory, degenerative and neoplastic lesions in an ageing population of Charles River CD rats. Commonly occurring inflammatory lesions included chronic nonsuppurative myocarditis, with associated myocardial fibrosis, mononuclear inflammatory cell infiltrate into the portal 0281CROO12 (FC-143) -4- 123 triads of the liver which was frequently associated with portal bile duct proliferation and perivascularmononuclear inflammatory cell infiltrate and multifocal chronic interstitial pneumonia in the lung. A high incidence of chronic sialadenitis occurred in male rats from the 300'and 30 ppm groups sacrificed at termination. The appearance of the salivary glands in these animals was typical of glands in the recovery stages of dacryosialadenitis, a common, highly contagious disease of laboratory rats. Its peculiar incidence in this study was attributed to the housing arrangement. Both affected groups were housed in-the same room and the unaffected groups were housed in other rooms. Although the incidence of sialadenitis in male rats from the 300 and 30 ppm groups was statistically significant, this increase was not considered compound related since it was explainable by the housing arrangement. Other statistically significant variations in incidence of non-neoplastic lesions which were not considered of toxicological significance included decreased chronic myocarditis in females from the 30 ppm group, increased lung hemorrhage in males from the 300 ppm group, decreased perivascular mononuclear cell infiltrate in the lung in males from the 300 ppm group and in males and females from the 30 ppm group and decreased splenic hemosiderosis in females from the 300 ppm group and in males and females from the 30 ppm group. Some of the more commonly occurring degenerative lesions in this study included adrenal cortical vacuolation and sinusoidal ectasia, focal mineralization in large pulmonary artery branches in the lung, focal acinar atrophy in the pancreas and chronic progressive nephropathy. Pituitary adenomas were the most common neoplasm in male and female rats. overall, the health of the rats in this study was excellent, with organs free of lesions of common infectious diseases which would have had an impact upon survival or the validity of the study. Robert G. Geil, D.V.M. Diplomate, American College of Veterinary Pathologists /Z Date 0281CROO12 (FC-143) -5- 124 TABLE OF CONTENTS Table Number 1 macroscopic Incidence for 2 Macroscopic Incidence for 3 Macroscopic Incidence for 4 Macroncopic Incidence for 5 Non-neoplastic Incidence 6 Non-neoplastic Incidence 7 Non-neoplastic Incidence s Non-,icoplastic Incidence 9 Neoplastic Incidence for 10 Neoplastic Incidence for 11 Ncoplastic Incidence for 12 Neoplastic Incidence for Paze Males - 1 Year Interim .............1.. Females - I Year Interim ...........2.. Males ...........................3.-.r.,.. Females ..........................6.-7... for Males - I Year Interim ...........F-.11 for Females - I Year Interim.........1.2-15 for Males .........................1.,.-).-.24 for Females ........................1.5-.3.3.. Males - 1 Year Interim ..............3.4. Females - I Year Interim ............3.5. Males ............................3.6.-.37.. Females ...........................38.-.3.9 . ApDendix Table Number 1 Single 2 Single 3 Tissue 4 Tissue Page Tabulated Animal Report - 1 Year Interim ..............1.-.27 Tabulated Animal Report ............................2.8.-.21.4. Inventory - 1 Year Interim ..........................2.15.-.2.19 Inventory ........................................L.l.cl.-.21.-.'.-'. 0261CROO12 (FC-143) .125 ii!crs,:'-)picIncid@-.c:t@irt.iiles T...Y,;ol@.Orral Toxi--ity-Otiz3j@@niciSttyudy in Rats - 0,1,Y!e.3rInteri!r. Spe:-*Ias:R--L Si Descriptioii Gro;jpI Grojp i Ey:? Pit..t,airy Liver pa I s .-1@-.--.r!y fat c 31or .iydrzrapni-o3@l.; cys.iz S:,fl-T-iss;.@ (lo-) s.I L Ti T.] Qi: r@roup 1 COtiTROL p;),i PPl 14acroszz)piIcnzida,i:e 126 Macroscopic Incidence for Females Riker Laboratories, Inc. 3M FC-1@,"):Tt-4oYear Oral Toxicity-Oncogenicity Study in Rats - One Year Interiii Tablc-: Project Nunb?r: Ci.@ICROI,;12Species: Rat sil.e/ Description No visible lesions Eye atrophy Pituitary enldrged Adr.,iial enlarged Liver pdle/tan* Lymph '.'-I.(d.eqesenteri-.) henorriia;ic i-L-se.it2ry MASS Kidr.ey hydron@-p.iro s calculi Ur.,ter dilatatio:,.c,alculi Urinary Bladder dist,-.-.dzc!adl,culi .ystic lesion enlarged dilated,fluid fiiled Mannary G13nd ri_lss n hair loss Group I Group 5 5 9 3 1 I 1 1 1 2 Titles: Group I Gr,)up 5 CO:.TROL ^jppn FC-1-@l.' :G@@ ppn, incltides"possibly" Macroscopic Incidence Page: 2 127 Macroscopic Incidence for Ndles Riker Laboratories, Inc. 31,1 FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Number: 32@ilCR)012 Species: Rat Site/ Description No visible lesions Brain dar'. area Eye opaci ty/cl oudy hypopyon Pituitary ridss/enlarged/raisedlesion dark/hemorrhagic/red foci Thyroid enlarged* Adrenal e-ilarged/mass Throax (internal) fluid filled Thymis enlarged* henarrhagic/h3morrhagic lesion mass Lung mottled frothy tracheal exudate consalidation* mass/raised lesion multiple .ihitelesions Heart flaccid/flabby enlarged* pale Abdo-.nen(internal gas, gastrointestinaltract stomach empty of food mass, onentu!i fatty tumor Stomach edema/thickened wall erosions/ulcerations* Small Intestine enlarged, reddened Peyer's patches Large Intestine enlarged, reddened Peyer's patches impaction Group 1 11 Group 5 J') Group 6 is 1 I 7 2 2 1 1 2 2 3 1 1 I I I I I 1 I I I I 1 1 I 1 1 I I 1 2 1 1 1 Table: 3 Titles: Group I Group 5 Group 6 CONTROL FC-142 FC-143 0 ppm 300 PPm 30 PPm includes "possibly" Macroscopic Incidence Page: 3 128 Macroscopic Incidence for Males Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Iluiber:021,lCRnOle'Species: Rat Site/ Description Paricre.-s ndss/nodule Liver pale/pale lo!)es* qass/.iod@;',e/raiseldesion .nottlad* yel Io.@lpile roci/lesion e!ilargied possibl-- corges*@io-i Sple@!n -2n'.arged r3iszd lesion pal: foci p:,l@-,depr,2ssed area Group 1 Group 5 Group 6 10 3 7 3 7 1 6 s 1 9 1 1 1 3 2 3 1 2 1 Lynph nod@-(rasenteri:,abdo-iir,.al) eiiiarg-3d greeni.;.l C3'lcr I.IosaAtery iadilar/.anl:irged/thickevnee,d.sels n3ss '4idney a:ilargcd,pile, pitted ei-.Iarpd,pitted pal,-,pitted ,)ale,enlargad' pale pall area hydronephrosis, p,,Ivicdilatation cystic/poly-.ystic Uri.iary Bl-,dd:@r distatidad he;.iaturia/filled with reddish/dark fluid hemorrhagic tiall T-2s,.is/Epididy-..iis nass Penis swollen Marnary Gland mas7. 2 2 2 I 1 2 1 1 2 1 1 3 2 3 3 2 1 2 1 1 6 1 1 2 TabIL, 3 Titles: Group 1 Group : Group 3 COIITROL 0 ppt" F@'-143 3"' ppil FC-14"@ 30 pp.*i includ-2s"possibly" Macroscopic Incidence P3-1: 4 129 Macroscopic Incidence for Males Riker Laboratories. Inc. 3M FC-143:Two Year Oral Toxicily-Onca2enicitSytudy in Rats Project ilu-iL)@a^ru:27-lCRJJ:@'Species: R@,t Site/ Description S'<in ulcers/inflan,,d/circular,fraised lesio.,ish,ind footpadi der.-iatitis/ulcer/lesion/ inflaned area* moist are3 iiairloss -nass/thic',,,-ning abscess infla,.iefdall Sa.'*,Tissue (neck) nass Sof-c Tissj:?(*.horix) mass S,)ftTisstj,(,leg) s.4:)Ilerpia-@@-s/feet stialle,j*oiints Group 1 Group 5 Group 6 7 1 2 Table: 3 Titles: ORDUP 1 Group 5 Group 5 CO!ITROL 0 PPM FC-I;"@ 30-3 ppm FC-143 3C ppm includes "possibly" Macroscopic Incidence Page: 5 130 macroscopicIncidence for Females Riker Laboratories, Inc. 3M FC-14,1:Tdo Year Oral Toxicity-Oncogenicity Study in Rats Pro,icct Nu.-iber:'.,Z-lCRO,'12Species: Rat Site/ Description i4ovisible l@sio,-,s Eye opaci@6y/cloudy infla-n.-itioii atrophy Pituitary mass/enlarged/raised lasion hemorrna,ic/dark lesion Adrenal enlarg2d mass/r.tised lesion pale small Lung mo*@tled consolidation nodile pale Ly.-ip@hiode (bro;icnial) enlarged Heart enl3rg2d* AbdoTie;i (iiiterr..,1 gas, gastroi,,itestintarlict bloody fluid filled iiodtil.atrissue, orertj,.nm,esentery St3na:h ulceratiii-is/erosio-is red mucosal areas/redd,@,i@,d S,-.alIlntestine infla-ied ulceration/ulcer3ted outpouching Li:rge Int@.stine inp.3ctio,i Pancra3s .idss/nodule Liver pale* mass/nodule/raised lesion mottled circul,irlesion/pale foci/ pale lesion/yello-disiliesion enlarged* Group 1 Group 5 Group 6 3 3 1 I ?5 2 3 p 3 7 1 I 1 1 2 1 1 1 1 1 1 1 1 1 2 I 1 2 1 2 1 1 1 j1i 3 6 2 2 1 2 2 1 2 Table: Titles: Grotip I Grojp 5 Group .- CO!ITROL FC-It'. FC-143 3 ppl 30n@ ppri 30 pp"i incl@idls"possibly" Macrcscnpi,- Incidence Page: 6 131 Macroscopic Incidence for Females Riker Laboratories, Inc. 3M FC-143: T%ioYear Oral Toxicizy-Oncogenicity Study in Rats Project 'lumber:3,tSlCRO,',12Species: Rat Site/ Description Liver (continued) dark red area/lobe rou;ii,'rireg:jalr surface Spleen etilarged* Ly,.iph nod@ (.-xse;it@,ric/abdominal) etilart,,cd reddened cystic Kidney .znlarged.pale, pitted enl3rged* pale, pitt;!d pitted pale* cy;t Urinary Bladder enlarg.,d calculi thic!.enedwalls Ovary mass Ut4?rjs e.ilarged filled -.fi*d"a*ri",/bl:)adfyl.jid ilisas dark ar,,3/lesion hemorrhagic lesion Marr.ia.-Gyla.iu' nass!nodule n;iI'.,cysl Sk in rais,-d/infla,qed/ulcerateldesio.-if,ootpad ,iass raised lesion hair loss/thi.iniig circular lesion Soft Tii;ues (ne:K) mass reddened, glane,like strictires Soft Tissues (leg) swollen foot Group I Group 5 Group 6 5 2 2 1 i 1 I 1 1 2 2 1 1 1 1 1 I I 1 1 I 1 27 37 3 3 I 1 1 I 2 3 1 I I Table: Titles: Group I Gr,)up5 Group 6 CO'.'TROL 0 ppn FC-143 '@03 ppm FC-143 20 ppn includes "possibly" Macroscopic Incidence Page: 7 132 Non-Neoplastic Incidence for Nales Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats - One Year Interim Table: 5 Project Nuc6er.,0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Adrenal Within normal limits Corticalvacuoldtion mild tiodularhyperplasia, cortex moderate Sinusoidal ectasia, cortex moderate Aorta Within normal limits Bone Marrow Within normal limits Brain Within normal linits Esophagus Within normal limits Eye Within normal limits Cataract Retindl atrophy minimal Heart Within normal limits Myocardial fibrosis minimal mild Myocarditis, chronic nonsuppurative minin.al mild Kidney Within normal limits Calculus Chronic progressive nephropathy minimal mild cyst Hydronephrosis moderate Mineralization Nephritis. interstitial,chronic mild Group I Group 5 ----------- ----------- 15) 12 1 1 1 1 1 1 (15) is (14) 14 15) 15 15) 15 15) is 0 0 0 15) 14 0 0 0 1 0 1 15) 5 1 8 5 3 1 1 1 0 1 1 15) is 0 0 0 0 0 0 11) 11 (15) is (15) is (15) 15 15) 13 1 1 1 15) 12 2 1 1 2 2 0 15) 4 0 10 6 4 0 0 0 1 0 0 Titles: Group 1 CONTROL 0 ppm Group 5 FC-143 300 ppm Total Examined Microscopic Incidence Page: 8 133 Non-.IjeoplasItni@c-ideicfeor t-lale(scontiiued) Riker Laboratories,Inc. 3r, FC-14*,,T:wo Year Oral Toxici,y-Oncogenici*.yStudy in Rats - One Year Interi.-.1 Table: 5 Pro.4ectiluib,@,r0:2@,ICRJO12 Spacies: Rat Tissue/ Diagnosis/ *4odifier Kidney (cort,.*.iued) Pyelitis, acutl% r.iiniinal .-.Ildi L@.rge Intes:irge Witiiiini,,;rne'Ii,.-.tisi iatudiasis Liver Withi,iiorilalimits Hop.iLccy',aelteration, vacuolated r.i1ni;7.-l1 mild HepaLocyte va@-;jolation rii;ii.-.ial iiiId flegalO'@ytosis r.iiii.-k1a nild r.ioderate itecr:)ssi nin4.mal 1 Kuptlercell mild Portalbile t;uctproliferation ..iinimal .liId Portalmoioriucleacrell infiltrate mininal nild Lu-ig Within nor.-@ilailmits Alveolar macrophr-ges nild Atelectasis mild Hemorrhage mild moderate Hyperplasia.septal ci:ll nild Group 1 Group 5 ---------------------- 15) !5) l@ 1.11 1) 1 13) 1c) 7 2 0 1 0 1 1 n 2 0 0 0 0 7 0 3 2 4 7 1 5 15) 15) 1 2 3 1 6 6 2 i 1 1 0 nv Titles: Group 1 CO::TROL @ ppn Group 5 FC-1,"@@300 ppn Total Examined M-.'croscopicIncidenca Pag,@: 134 ?Ion-tleoplas*6Iincidence for liales(continued) Riker Laboratories. Inc. 3.'4 FC-141-:T6ioYear Oral Toxicity-Oncogenicity Study in Rats - One Project 14umbAr:0251CR)012 Sp2cies: Rat Year Interim Table: 5 Tissue/ Diagnosis/ Modifier Lu,-i(gcontinued) Parivascjlarmcnonuclearinfiltrate mild Pneu,-ionia,interstitialc,hronic mi ni.-i1a .i1id Vascularriineralization minimal mild Ly,-ipth.'od(enesenecric) Withi-,tior.-.liiamlits He,iorrnage r.tinin.,l r.iiI d tia.-nary'ualnc! Withi-,niormal Iiqits Ile:o;n L:!ry ;iccl*osifsa,t marked Steatitis,chroriic ,.loderatc P3ncre.is ',Iithrionrm3llimits Aciiiaratrophy nild moderate Pa,icr.@atiticsh,rz)!iic .@iIid Parat;iyroid '.iithirnor-.nallimits Pituitary Within normallimits Cyst Prostate Within normallimits Prostatitis, chronic mini-i3i SalivaryGla-id Within normal 1iiits Small Intesti-ic Within normal limits Group 1 Group 5 ----------- ----------- 1 2 1 3 2 1 2 2 7 3 4 1 3 7 13) 13) 13 11 0 2 3 1 0 1 3) 0) 3 1 1) 0) I 1 0 1 0 1 0 15) 15) 11 @5 3 2 1 0 3 0 0 7) 3) 7 3 14) 12) 13 12 1 0 (15) 13) 15 12 0 1 L; I (15) 14) 15 ill 15) 15) 15 15 Titles: Group I CONTIOL 0 ppm Gro-.jp 5 FC-14-- 33v'pp@,i Total Examined @licroscopicIncideice Page: 1'v@ 135 Non-NeoplasticIncidencefor Males (continued) Riker Laboratories.Inc. 3M FC-143: Two Year Oral Toxicity-OncogenicityStudy in Rats - One Year Interim Table; 5 Project Number: 0291CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Spinal Card Within normal liriits Spleen Within normal limits Hemosiderosis mild Stomach Within normal limits Testis/Epididymis Within normal limits Tubule atrophy, aspermatogenesis marked Thyroid Within normal limits Trachea Within nomal limits Urinary Bladder Within normal limits Group 1 Group 5 ---------------------- 14) ( 15) 14 is 15) (15) 15 14 0 1 0 1 14) (15) 14 is 15) 15) 15 13 0 2 0 2 11) 13) 11 13 15) (15) is 15 15) (13) 15 13 Titles: Group 1 CONTROL 0 ppm Group 5 FC-143 300 ppm Total Examined Microscopic Incidence Page: 11 136 Won-Neoplastic Incidence for Females Riker Laboratories,Inc. 3M FC-143: Two Year Oral Toxicity-OncogenicityStudy in Rats - One Year Interim Table: 6 Project Number: 0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Adrenal Within normal limits Cortical degeneration mild Sinusoidalectasia, cortex mild marked Aorta Within normal limits Bone Marrow Within normal limits Brain Within normal limits Esophagus Within normal limits Eye Within normal limits Atrophy marked Panophthalmitis marked Heart Within normal limits Myocarditis,chronic nonsuppurative minimal mild Kidney Within normal limits Calculus mild moderate Chronic progressive nephropathy mild cyst mild Hydronephrosis moderate marked Hyperplasia,pelvic epithelium mild Mineralization mild Group 1 Group 5 ---------------------- 15) 10 2 2 4 3 1 (14) 14 (15) 15 15) is 15) is 15) 14 1 1 1 1 15) 14 1 1 0 15) 6 4 1 1 1 1 1 1 1 1 0 1 1 0 0 15) 11 1 1 3 3 0 13) 13 (15) is (15) 15 (13) 13 (15) 13 2 2 2 2 15) 14 1 0 1 15) 9 2 1 0 3 3 0 0 1 0 1 0 0 1 1 Titles: Group 1 CONTROL 0 ppm Group 5 FC-143 300 ppm Total Examined Microscopic Incidence Page: 12 137 Non-Neoplastic Incidence for Females (continued) Riker Laboratories. Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats - One Year Interim Table: 6 Project Number: 0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Kidney (continued) Pelvic mineralization minimal mild Pyelitis, chronic moderate Large Intestine Within normal limits Nenatodiasis Liver Within normal limits Nepatocyte alteration, vacuolated mild Hepatocyte vacuolation minimal mild Portal bile duct proliferation mild Portal mononuclear cell infiltrate minimal mild Lung Within normal limits Alveolar macrophages mild Hemorrhage mild moderate Perivascular mononuclear infiltrate mild Pneumonia, interstitial, chronic mild Vascular mineralization mild Lymph Node (nesenteric) Within normal limits Hemorrhage marked Mammary Gland Within normal limits Galactocele Group 1 Group 5 ---------------------- 4 4 0 0 0 (14) 12 2 (15) 6 1 1 5 3 2 2 2 2 1 1 15) 3 1 1 ii 9 2 1 1 1 1 1 1 (12) 12 0 0 (15) 13 2 1 0 1 1 1 (14) 12 2 (15) 3 0 0 11 1 10 1 1 2 0 2 15) 5 1 1 9 7 2 0 0 0 0 1 1 13) 12 1 1 13) 10 1 Titles: Group 1 CONTROL 0 ppm Group 5 FC-143 300 ppm Total Examined Microscopic Incidence Page: 13 138 tion-licapl.'stIinCcidence for Feiales (continued) Riker Laboratories. Inc. 3M FC-I*-i:T%ioYear Oral Toxicity-OnzogenicityStudy in Rat; - One Year I,-iteri!.l Table: Project t4u,.nber0:231:["Z@@12 Species: Rat Tissu2li Diagnosis/ @iodifier Neseit@@ry tlecrosis,fat r,ioder,ite Steatitii, chronic .i.ioderate 0-,iry Wi*.hiin-o.r.mal lirits Cyst Pazicreas Wi@,hi:,n,or*.ialli,.iits Pancreatitis, c.4roriic .iiId ,IaratiVroid Withir.nor,-.ilailmits Pituitary Wi*6h,inornii li.,iits Saliv;iryGland *@itlii@inor@iial I i,,@tisi S.,.i:i Witliin!i:)r.-,Ilia.l-itis S,iallIii-:esiine Within .Ior-.iallinits Spi!-,:Cl.)rd Withi.1 i@oriiallimits (.0;i Withi,inor,,,ilailni-.s He-.iosiderosis ,niId Ston.ach Wit.@i@-.iior.-,iallimits Thyroid Wit.'iiiniornal Ii.,tisi Traci-te-a Within normal limits Ur3ter Calcult;s Dilatation mar'.,ed Inflart.ia*6iocnh,ronic moderate Group 1 Gkaroup 5 ---------------------- 1 1 i is) 14 11 15) 1 6*t I 1 6) 5 is) 14 is) 15 2) 2 15) 15 1 15) 1 1 15) 15 14) 14 15) i5 u 0 3 D r (ic@) i5 0 15j' is 9) 9 (14) 14 (15) 15 1 .5 15) is i@) 15 13) 1,3 15) 15 Titles: %Droup 1 CO:IT;ZOLJ ppn Group 5 FC-14'-@300 pprn. Total Exa,,iired Micr.,)Scopic Incidence Pag@: 1', 139 Mon-Neoplastic Incidence for Females (continued) Riker Laboratories, Inc. 3m FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats - One Year Interim Table: 6 Project Number: 0281CRO312 Species: Rat Tissue/ Diagnosis/ Modifier Urinary Bladder Within normal limits Cystitis, chronic moderate Epithelial hyperplasia, simple mild Uterus Within normal limits Cystic glands marked Endometritis, chronic mild Hydrometra moderate Hyperplasia, glandular epithelium mild Metaplasia, squamous mild Group I Group 5 ---------------------- 12) 15) 12 14 0 1 0 1 0 1 0 1 15) 15) 12 13 1 0 1 0 0 1 0 1 0 2 0 1 2 0 2 0 2 0 2 0 Titles: Group 1 CONTROL 0 ppm Group 5 FC-143 300 ppm Total Examined Microscopic Incidence Page: 15 140 Non-Neoplastic incidence for 14ales Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity study in Rats Project @4uWer: 0231CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Adrenal Within normal limits Cortical degenaration moderate Cortical vacuolation minimal mild modarate markad Medulldry cell hyperplasia minimal mild moderate 'Jodularhyperplasia, cortex minimal mild moderate Sinusoidal actasia, cortex minimal mild moderate marked Aorta Within normal limits Mineralization mild liecrosis moderate Bone Arthritis, synovi*6is;joints moderate marked Bone I-larro%i Within normal limits Brain Within normal limits Abscess mild Hemorrhage moderate Group I Group 5 Group 6 ----------- ---------------------- DOS SAC DOS SAC DOS SAC 15) 34) 6 13 0 0 0 0 7 17 9 2 4 13 3 2 0 0 2 6 0 z 1 4 1 2 0 2 3 0 0 1 1) 1 4 7 0 2 2 3 2 2 0 0 15) 34) 13 34 1 0 1 0 1 0 1 0 0) 2) 0 2 0 0 0 2 15) ( 32) 15 32 16) ( 34) 14 33 1 0 1 0 1 0 1 0 6) 44) 2 12 0 0 3 0 2 11 1 2 1 5 0 4 0 0 1 6 0 2 1 4 0 0 1 1 0 0 7 0 1 0 16 0 2 0 10 0 3 0 1 6) 43) 6 43 0 0 0 0 3 0 0 0 0) 1) 0 1 0 1 0 0 ( 6) ( 42) 5 42 ( 6) ( 44) 5 44 0 0 0 0 0 0 0 0 14) 35) 6 is 0 2 0 2 4 5 3 0 3 5 0 0 1 0 0 3 0 0 n,j 3 0 0 1 0 0 0 0 0 1 5 8 0 1 4 5 1 2 0 0 0) 0) 0 0 0 0 3 0 0 0 D 0 0) 1) 0 1 0 1 0 0 ( 3) ( 0) 0 0 ( 0) ( 1) 0 0 0 0 0 0 0 0 0 0 Titles: Group 1 CONTROL 3 ppm Group 5 FC-143 300 ppm Group 6 FC-143 30 ppm Total Examined DOS- Unscheduled Beath(s) SAC, Protocol Scheduled Sacrifice(s) 14 1 Microscopic Incidence Page: 16 Non-MeoplasticIncidence for Males (continued) Riker Laboratories.Inc. 3M FC-143: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0231CRO312 Species: Rat Table: 7 Tissue/ Diagnosis/ @iodifier Esophagus Within normal limits Eye Within normal limits Cataract Keratitis,acute marked Keratitis,chronic mild moderate Phthsis buibi marked Retinal atrophy r.iIid marked Heart Within normallimits Endocarditis,chronic marked Myocardial fibrosis n;ild Myocarditis,chronic nonsuppurative minimal mild moderate Kidney Within normal limits Calculus minimal mild Chronic progressive nephropathy minimal mild moderate Cyst marked moderate marked Hydronephrosis mild moderate Group 1 Group 5 Group 6 --------------------------------- -DOS SAC DOS SAC DOS SAC (15) 15 (12) 12 0 0 0 0 0 0 0 0 0 0 0 16) 8 0 0 3 3 4 0 4 0 16.) 4 0 0 0 10 1 5 2 2 1 0 1 1 1 0 33) ( 33 33) ( 32 a 0 0 0 0 0 0 0 1 1 0 34) 23 0 0 2 2 10 2 7 1 34) 0 1 1 0 34 4 16 11 3 3 1 2 2 0 2 6) ( 41) 5 41 6)( 44) 4 41 0 0 1 0 1 0 0 1 0 0 0 1 0 1 0 1 0 1 0 0 0 1 6) 44) 6 '@)7 0 0 0 0 0 1 0 1 0 17 0 5 0 12 0 0 6) 44) 1 2 1 0 0 0 1 0 3 40 1 9 0 23 1 6 1 2 0 1 0 1 0 0 0 1 0 1 0 0 13)( 32) 13 32 2)( 3) 1 0 1 2 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 1 0 0 0 0 14) 36) 9 19 0 1 0 1 1 6 1 6 5 13 0 1 4 12 1 0 14) 3r,) 3 2 0 1 0 0 0 0 9 34 2 2 3 22 2 7 2 3 1 1 1 0 0 0 0 0 0 0 0 0 Titles: Group 1 CONTROL 0 pPm Group 5 FC-143 300 ppm Group 6 FC-143 30 ppm Total Examined DOSs Unscheduled Death(s) SAC, Protocol Scheduled Sacrifice(s) 14 2 Microscopic Incidence Page: 17 Non-Neoplastic Incidence for Males (continued) Riker Laboratories. Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Number: 0281CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Kidney (continued) Hyperplasia, pelvic epithelium mild moderate Mineralization mild Nephrosis moderate Papillary necrosis moderate Pelvic mineralization minimal mild moderate marked Protein resorption droplets mild Pyelitis, acute mild Pyelonephritis, acute mild moderate Vacuolation, conv. tub. epitheium minimal Large Intestine Within normal limits N,,matodiasis Liver Within normal limits Cystoid degeneration minimal mild moderate Hematopoiesis, extramedullary mild Hepatocyte alteration. basophilic minimal mild moderate Hepatocyte alteration, vacuolated mild moderate Group 1 Group 5 Group 6 ---------------------- ----------- -DOS SAC DOS SAC DOS SAC 0 0 0 0 0 0 0 0 0 0 1 0 1 0 1 0 1 0 1 3 0 1 1 2 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 (14) ( 34) 14 28 0 6 (16) ( 34) 2 0 0 4 0 1 0 2 0 1 0 0 0 0 0 2 0 0 0 1 0 1 1 9 1 7 0 2 0 3 0 2 0 1 0 1 0 1 0 0 a 0 0 0 0 0 0 3 0 1 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 2 u 1 0 0 0 0 6) ( 44) 6 44 0 0 6) ( A4) 0 0 1 27 0 2 1 22 0 3 0 0 0 0 0 6 1 0 2 0 3 0 10 0 8 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4 6 0 1 3 3 0 2 1 0 1 0 1 0 1 2 1 2 0 0 0 0 0 0 1 0 1 0 ( 1) ( 0) 1 0 0 0 ( 14) ( 36) 1 6 2 5 0 1 2 4 0 0 1 0 1 0 0 1 0 0 0 1 0 0 1 10 1 9 0 1 Titles: Group 1 CONTROL 0 ppn, Group 5 FC-143 300 ppin Group 6 FC-143 30 ppm Total Examined DOSZ Unscheduled Death(s) SACs Protocol Scheduled Sacrifice(s) 14 3 Microscopic Incidence Page: 18 Non-!IeoplasticIncidence for Males (continued) Riker Laboratories, Inc. 3M FC-141@: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Munber: 0281CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Liver (continued) Hepatocyte vacuolation minimal nild moderate marked Hyperplasia, Kupffer cell moderate Hyperplastic nodule @legalocytosis riinitral mild moderat,- Mononu.-learcell infiltration mild Ilecrosis minimal mild moderate Portal bile duct proliferatioi minimal mild moderate Portal mononuclear cell infiltrate minimal mild Lung Within normal limits Alveolar macrophages minimal mild moderate marked Atelectasis moderate Edema mild moderate marked Fibrosis mild moderate Group 1 Group 5 Group 6 ----------- ---------------------- DOS SAC DOS SAC DOS SAC 3 14 0 1 4 13 2 0 2 0 0 0 0 0 0 0 0 a 0 3 0 0 0 0 0 0 0 0 2 1 u 0 1 0 1 1 6 21 0 0 5 21 1 0 7 3C 3 2 7 2a 15) 34) 0 1 5 5 1 2 4 2 0 1 0 0 0 0 0 0 3 3 1 0 1 3 1 0 1 L) 1 0 0 2 10 1 1 0 8 1 1 0 0 0 0 0 0 0 3 2 33 2 24 0 la 0 4 0 0 0 0 2 3 0 1 1 1 1 1 1 14 0 1 1 13 0 0 5 43 0 2 5 41 5) 44) 0 0 27 0 0 3 25 0 2 1 1 0 0 0 a 3 0 0 0 0 0 0 0 1 0 0 3 1 & 2 3 1 3 1 3 0 0 0 0 1 0 1 0 0 0 6 0 6 0 0 0 0 0 1 0 1 2 3 0 1 1 2 1 0 5 13 0 0 5 10 0 0 7 25 0 3 7 25 14) 35) 1 2 6 ic 0 0 6 8 0 2 0 c 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Titles: Group 1 COIITROL 0 ppm Group 5 FC-143 300 p;xn Group 6 FC-"43 30 pp-,a Total Examined ODS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifi-.e(s) 14 4 Microscopic Incidenc3 Page: 19 Proj@,ct 14u,.nb2r: Non-Neoplastic Incidence for Males (continued) Ri4er Laboratories, Inc. 3M FC-143: T4;3Year Oral Toxicity-Oncogenici,@y Study in Rits Species: R:it Tabl-2: 7 Tissie/ 0-4igilosis/ Modifier Lui-,g(:on'-inu,@d) G r a:-i@ ',o,,.l;i n4ld moderate ,i,ir -:,zd M2di,', hyperti-.)p.@ya,r*t-ri@s r,oderdt'L ;2ecr.)s-*s ar d P n,r ibr o -ic h i ;I ly;:-.p4oildiyperplasia .liId Oerivas--jlariio-ion.-claianrfiltrate ;iild moderat2 Pneu-,ioniai,nterstizial, ac..-te moderate Pneu,.ioniai,nterstitial, chronic mild -ioderate T,'irombus Vascular min?raliz=.tio.-. minimal ,-,Iiid moderate Ly!iphIlod,@(nesenteric) Within normal limits Granuloma .ioderate Hanarrhage minimal mild Sinusoidal ectasia nild Mammary Gland Within norial linits Mesentery Polyarteritis marked Gro-.tp I 'urtup 5 Group L ----------- ----------- ----------- -DOS SAC DOS SAC DOS SAC 2 1 1 3 1 3 C: 1 13 1 L, 0 i 2 1 1 1 10 0 10 0 12) 10 0 0 2 1 1 0 0 0) 0 0) 0 0 14 3 0 0 11 3 u 33 2 31 33) 29 0 4 z 1 0 0 0) 2) 2 2 9 7 2 0 1 c 0 1 G 0 0 1 11.3 C. 0 4 41 0 2 6) 41.1) 5 33 3 1 0 1 u 4 i 1 0 3 .3 1 0 1 0) 0) 0 0 0) 0) 0 0 0 1 1 3 0 11 1.1 1 0) 0 0 3 r, 0 0 0 0 1) 1 1) 1 1 5 5 0 0 ;cl li @@2 1) 1 0 0 0 0 0 0 0 3) 0 1) i 1 Titles: Group I CONTROL 0 ppm Group G ra Up 5 FC-14-- 30J ppm r FC-14@' 30 P;).l Total Examined DOSC Unscheduled Dea*.h(s) SACC Protocol Scheduled Sacrifice(;) 45 Micros@,opic lscide,ice Pa;c: Non-Neoplastic Incidence for Males (coitinued) Riker Laboratories. Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Number: 0281CROD12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Pancreas Within norniallimits Acinar atrophy minimal mild moderate marked Hyperplasia, acinar cell mild moderate Hyperplasia, islet cell nild moderate Polyarteritis minimal moderate marked Parathyroid Within normal limits Pituitary Within normal limits Cyst Hyperplasia mild Prostate Within nornal limits Edema moderate Prostatitis, acute minimal mild moderate marked Salivary Gland Within normal limits Sialadenitis. acute moderate marked Sialadenitis, chronic minimal mild moderate Group 1 Group 5 Group 6 ----------- ---------------------- -DOS SAC DOS SAC DOS SAC 13) 33) 10 24 2 4 0 0 1 2 1 1 0 1 0 0 0 0 0 0 0 2 0 0 0 2 0 4 0 0 0 2 0 2 5) 16) 6 16 15) 33) 7 im 2 2 0 2 0 2 13) 33) 10 27 1 0 1 0 3 6 0 0 1 2 1 3 1 1 ('12) 3'L) 12 31 0 0 0 0 0 0 0 1 0 1 0 0 0 0 6) 43) 4 27 0 11 0 1 0 6 0 4 0 0 1 1 0 1 1 3 1 3 0 0 1 3 0 2 0 0 0 2 0 0 5) 31) 5 29 5) 41) 3 28 0 2 0 0 0 0 6) 43) 5 40 0 0 0 0 1 3 0 1 0 0 0 1 1 1 5) 41) 4 25 0 1 0 1 0 0 0 ip, 0 0 0 0 0 7 12) 10 1 1 0 0 3 0 0 0 1 1 0 0 0 3 0 7) 7 13) 3 1 0 0 13) 11 0 0 2 0 1 0 1 10) 10 0 0 0 0 0 0 0 34) 21 a 1 5 2 0 2 1 1 1 1 0 3 1 2 0 26) 26 34) 20 4 2 1 35) 35 0 0 1 0 1 0 0 34) 21 1 0 1 12 0 1 6 Titles: Group 1 CONTROL 0 ppn Group 5 FC-143 300 ppm Group 6 FC-143 30 ppm Total Examined DOS- Unscheduled Death(s) SAC= Protocol Scheduled Sacrifice(s) 14 6 Microscopic Incidence Page: 21 Non-HeoplastiIcncidencefor Males (continued) Riker Laboratories,Inc. 3M FC-143: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0231CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Group I Group 5 Group 6 --------------------------------- DOS SAC DOS SAC DOS SAC SalivaryGland (continued) Sialadenitis,chronic marked Skin Abscess Pododernatitis,ulcerative marked Ulcer marked S.iallIntestine Within normal limi-6s Polyarteritis moderate mar',-ed Spinal Cord Within normal limits Spleen Within normal limits Atrophy moderate Fibrosis moderate Hen,atopoiesis,extramedullary, increased mild moderate marked He-.nosiderosis mild Necrosis moderate Polyarteritis moderate Stomach Within normal limits Edema moderate marked Gastritis,acute mild Ulcer marked 0 0 "U)( 7) 0 0 3 5 3 5 1 0 1 0 14)( 34) 13 32 0 2 0 1 0 1 15)( 32) 15 32 16)( 34) 5 20 0 0 0 0 0 1 C) 1 4 0 2 0 1 0 1 0 5 11 5 11 0 1 0 1 0 0 0 0 16) 33) 11 33 3 0 2 0 1 0 0 0 0 0 1 0 1 0 0 7 0) 2) 0 0 0 1 0 1 0 0 0 0 6) 44) 5 44 0 0 0 0 0 0 ( 6) ( 42) 5 42 ( 6) ( 44) 1 25 1 0 1 0 0 0 0 0 1 1 u 1 1 0 0 0 3 19 3 in, 0 0 3 0 0 0 0 0 6) 44) 5 43 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 5 5) 4) 1 0 2 2 2 2 0 1 0 1 1) 0) 1 0 0 0 0 0 0 0 0) 0) 0 0 14) 33) 8 35 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 4 0 4 0 0 0 0 0 0 1 0 1 14) 35) 11 35 0 0 0 0 0 0 0 0 0 3 3 0 3 0 Titles: Group 1 CONTROL 0 pp-n Group 5 FC-143 300 ppm Group 6 FC-143 30 ppm Total Examined DOS- Unscheduled Death(s) SAC= Protocol Scheduled Sacrifice(s) 14 7 Microscopic IncidencePage: 22 Man-Neoplastic Incidence for Males (continued) Riker Laboratories. Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Number: %^,281CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Testis/Epididymis Within normal limits Granuloma, spermatic Leydig cell hyperplasia mild moderate Mineralization mild Polyarteritis mild moderate marked Tubule atrophy, asparmatogenesis mild moderate marked Vascular mineralization mild mod,3rate Thymus Hemorrhage marked Thyroid Within normal limits Cyst, colloid mild Follicular hyperplasia, cystic moderate marked Hyperplasia, C cell mild moderatc Ultimobranchial cyst Trachea Within normal limits Urinary Bladder Within non,-.alimits Calculus Cystitis. acute moderate Cystitis, chronic minimal Group 1 Group 5 Group 6 ---------------------- ----------- DOS SAC DOS SAC DOS SAC li) 33) 13 26 0 0 0 0 0 0 0 0 0 1 0 1 1 5 1 1 0 1 0 3 3 4 1 1 1 1 1 2 c@ 0 0 0 0 0 1) 0) 0 0 0 0 12) 3'L) 11 25 0 1 0 1 0 1 0 1 0 0 0 1 0 1 0 0 I 1 (15) ( 34) 15 34 (13) ( 33) 13 32 0 0 1 0 1 0 0 0 0 0 6) 44) 5 23 0 0 0 1 3 1 0 0 0 2 0 2 0 2 0 0 0 2 0 0 1 10 0 1 0 3 1 6 0 9 0 7 0 2 1) 1) 0 1 0 1 5) 42) 4 33 1 1 1 0 0 1 0 1 0 0 0 1 0 1 0 0 0 3 6) ( 42) 6 4," 6) ( 44) 5 41 0 0 0 0 0 0 0 0 0 0 14) 35) 7 26 1 0 1 1 0 1 1 0 0 0 0 0 1 5 0 1 2 0 1 5 5 3 0 1 1 1 4 3 0 3 0 0 0 1) 0) 0 0 0 0 12) 35) lrl 26 0 1 0 0 i 1 0 0 1 1 1 5 1 3 0 2 1 2 (13) ( 35) 13 35 (14) ( 35) 11 35 1 0 0 0 0 0 1 0 1 0 Titles: Group 1 CONTROL 0 pp,-i Group 5 FC-14" 300 ppm Group 6 FC-143 30 ppin Total Examined DOSs Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) Microscopic Incidence 1*4 8 Page: 23 Non-NeoplasticIncidence for Males (continued) Riker Laboratories,Inc. 3M FC-143: Two Year Oral Toxicity-OncogenicityStudy in Rats Project 14u*,nbe0r2:31CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Urinary Bladder (continued) Epith.:!Iiahlyperplasia,papillary mild Epithelialhypei-plasia,simple minimal mild Hemorrhage minimal marked Group 1 Group 5 Group 6 --------------------------------- DOS SA!.' DOS SAC DOS SAC 0 0 0 0 2 1 0 0 2 1 1 0 0 0 1 0 0 0 0 0 1 3 0 1 1 2 0 1 0 1 0 0 1 0 1 0 3 0 0 0 3 0 0 0 0 0 0 0 Titles: Group I CONTROL 0 ppm Group 5 FC-143 300 ppm Group 5 FC-143 30 ppm Total Examined DOS= Unscheduled Death(s) SACs Protocol Scheduled Sacrifice(s) 14 9 Microscopic Incidence Page: '@4 Won-Meoplastic Incidence for Females Riker Laboratories, Inc. 3M FC-143: Two Year Dril Toxicity-Oncogenicity Study in Rats Project Nimber: 0251CR,'j'@12Species: Rat Table: 9 Tiss-.ie/ Diagnosis/ Modifier Adrenal Within normal limits Cortical atrophy moderate Cortical degeneri*lion mild moderate marked Cortical vacuolation mild moderate Hematopoiesis, @xtramedullary mild moderate marked He:iiosdierosi s mild Medullary cell hyperplasia mild moderate Necrosis moderate marxed .'Iodulahryperplasia, cortex moderate Sinusoidal ectasia, cortex mini-,nal mild moderate marked Aorta Within normal limits Mineralization mild Bone Marrow Withi.inormallimits Brain Within normal limits Esophagus Within normal limits Group 1 Group 5 Group 6 ---------------------- ----------- DOS SAC DOS SAC DOS SAC 25) 25) -2 (1 1 0 0 0 2 5 1 --j 1 3 0 2 3 2 2 1 1 1 4 0 3 0 1 0 0 0 0 0 0 0 1 2 1 2 li 0 3 0 1 0 2 0 0 3 0 0 19 23 1 1 3 4 5 3 5 9 21) ( 23) 17 23 2 0 2 0 25) ( 2'j) 23 25 25) 25) 25 24 15) 21) 14 21 2@) 4 1 1 1 0 0 1 1 1 0 0 0 0 0 0 0 2 1 1 0 0 0 0 0 16 0 9 3 4 19) ji 0 0 21) 21. 21) 21 9) 9 29) 26) 2 3 2 0 2 0 0 4 3 1 0 3 0 0 3 4 2 1 1 3 0 1 0 0 0 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 25 @l 1 1 6 7 7 7 11 5 27) ( n) 27 0 0 0 0 0 29) ( 0) 2-3 G 29) ( 0) 20 15) ( 23) is 23 24) 1 0 0 4 2 2 0 1 1 0 1 0 1 0 0 0 2 2 0 0 0 0 2 2 '112 0 3 13 0 0 0 f,) 0 '.1) 0 22) 22 Titles: Group 1 CONTROL 0 ppm Group 5 FC-1414 300 ppm Group 6 FC-14.7 30 ppm Total Exa-nined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 15 0 Microscopic Incidence Page: 25 Won-Neoplastic Incidence for Females (continued) Riker Laboratories. Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Number: 0231CR3012 Species: Rat Table: 2 Tissue/ Diagnosis/ Modifier Eye Within normal limits Cataract Keratitis, acute marked Panophthalmitis marked Phthsis bulbi moderate Heirt Within normal limits Myocardial fibrosis minimal mild 14yocarditis, chronic nonsuppura*live minim,il nild moderate Kidney Within normal limits Chronic progressive nephropathy minimal mild moderate marked Cyst moderate Hydronephrosis moderate Hyperplasia, pelvic epithelium mild Mineralization mild moderate Nephrosis fni 1 d moderate marked Pelvic mineralization minimal mild moderate Group I Group 5 Group 6 ---------------------- ----------- DOS SAC DOS SAC DOS SAC (,?0) 17 1 1 1 0 0 0 3 25) 19 0 0 0 6 0 4 2 25) 3 12 3 5 2 2 2 2 1 1 4 4 2 2 0 7 1 2 14 4 a 1 23) 21 0 0 0 1 1 1 1 25) 14 0 2 10 0 10 0 25) 3 it, 4 10 3 1 1 0 0 0 1 1 n 0 0 0 0 0 0 16 6 8 2 16) 28) 16 28 C. 0 0 0 0 0 0 D 0 0 0 0 0 0 21) 29) 15 24 1 1 0 1 1 0 5 5 1 1 4 4 0 0 21) 29) 7 4 7 19 5 4 1 12 0 2 1 1 0 0 0 0 0 1 3 2 0 D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 10 14 4 6 4 7 1 0 2) 1) 1 1 0 0 1 1 0 3 0 0 0 0 0 0 0 26) 24) 25 20 0 0 0 0 0 0 1 4 0 0 1 4 0 0 26) 24) 5 5 12 9 4 5 a 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 1 2 0 1 0 1 1 0 12 is 4 6 6 6 0 2 Titles: Group Group Group I CONTROL 0 ppn 5 FC-143 300 ppm 6 FC-143 30 ppm Total Examined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 15 1 Microscopic Incidence Page: 26 Mon-NeoplaStiC Incidence for Females (continued) Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Nunber: 0231CR'012 Species: Rat Table: I Tissue/ Diagnosis/ Modifier Kidney (continued) Pelvic mineralization marked Pigmait, conv. tub. epithelium minimal noderate Polyarteritis minimal Protein resorption droplets mild marked Pyelitis, acute mild moderate Pyelon-3phritis,acute moderate Vacuolation, conv. tub. epitheium moderate Large Intestine Within normal limits MematDdiasis Liver Within normal limits Atrophy moderate Cystoid degeneration minimal mild Hematopoiesis, extramedullary minimal mild moderate Hepatocyte alteration, basophilic minimal mild moderate Nepatocyte alteration, eosinophilic mild moderate Hepatocyte alteration, vacuolated minimal mild Group 1 Group 5 Group 6 ----------- ---------------------- DOS SAC DOS SAC DOS SAC 1 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 (24) 22 1 (25) 1 0 0 0 0 0 3 0 3 0 1 u 1 0 1 1 2 0 2 0 1 1 2 1 0 0 1 0 2 0 0 1 0 c 0 0 0 0 2 0 0 0 1 0 0 0 0 1 0 1 0 1 1 0 1 0 0 1 0 1 n 1 0 0 2 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 @ll 23) (17) ( 29) ( 0) ( 0) 22 17 27 0 0 1 0 2 0 0 25) (21) ( 23) ( 25) ( 'I) 0 4 4 7 7 0 0 1 2 0 0 0 1 0 0 0 1 1 0 0 3 1 0 0 0 0 0 1 0 0 1 u 5 2 0 0 0 3 1 0 0 0 2 1 0 1 0 0 0 7 0 2 5 3 0 0 1 0 0 s 0 1 5 3 2 0 0 0 0 2 0 0 0 0 2 0 0 0 0 3 3 0 0 0 11 2 4 1 5 0 1 0 0 1 11 1 1 0 4 Titles: Group 1 CONTROL 0 ppm Group 5 FC-143 20C ppm Group 5 FC-143 30 ppm Total Examined DOS= Unscheduled Death(s) SAC= Protocol Scheduled Sacrifice(s) 15 2 Microscopic Incidence Page: 27 Non-Neoplastic Incidence for Females (continued) Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxici*.y-OncogenicityStudy in Rats Project Number: 0231CR3012 Species: Rat Table: 8 Tissua/ Diagnosis/ Modifier Liver (continued) Hepat,)cytealteration, vacuolated mar4ed Hepatocyte vacuolation minimal nild moderate m.:irked Hyperplastic nodule MC-3alocytosis minimal mild Mitotic activi-6y,increased moderate Mononuclear cell infiltration mild 11-2crosis nini:.ial mild moderate mar%ed Pig-ient,Kupfer call mild Portal bile duct proliferation r,iIid moderate .nar@ed Portal monoluclear cell infiltrate minimal mild moderate Tel an@,iec ta s i s mild Lung Within normal limils Abscess Alveolar macrophages minimal mild moderate Atelectasis ;ai1d Group I Group 5 Group 6 ----------- ---------------------- DOS SAC DOS SAC DOS SAC 0 0 15 is 1 1 13 3 1 2 0 0 1 0 c 0 0 0 0 1 0 1 0 0 0 0 0 4 1 3 0 1 1 1 0 2 0 13 0 0 4 13 3 12 1 0 10 9 1 0 9 1 0 1 a 1 0 f 25) 25) 2 3 1 0 5 9 1 0 4 9 0 i 0 0 0 0 3 0 8 13 0 3 5 11 0 1 3 0 2 1 7 1 6 0 1 0 0 0 0 1 0 1 3 2 0 c 0 1 0 0 0 1 0 1 0 1 0 5 9 5 -3 0 1 0 0 4 is 0 2 4 J-) 0 1 0 0 0 21) 29) 1 3 0 c 6 13 2 0 4 12 0 1 0 0 0 0 1 0 7 9 2 2 7 2 0 1 0 0 a 1 0 1 0 v 0 0 1 0 0 0 0 0 6 0 1 0 3 0 0 0 3 I) 1 4 1 4 0 0 0 5 5 0 r 4 0 0 0 0 0 0 ?6) 24) 2 2 0 3 7 0 1 3 6 0 v 1 0 1 0 Titles: Group 1 CONTROL @l PPm Groap 5 FC-143 3@--2PP." Group 6 FC-143 30 PPM Total Exa-nined DOS- Unscheduled Death(s) SAC= Protocol Scheduled Sacrifice(s) 53 Microscopic Incidence Page: Z.; Non-Neoplastic Incidence for Females (continued) Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Number: 0281CROO12 Species: Rat Table: 3 Tissue/ Diagnosis/ Modifier Lung (continued) Edema mild Graiulona mild marked Hemorrhage minimal mild moderate marked Hyperplasia, septal cell mild Perivascular mononuclear infiltrate minimal mild moderate Pigment moderate Pneumonia, acute exudative mild moderate Pneumonia, foreign body marked Pneumonia, interstitial,chronic minimal mild marked Vascular mineralization minimal mild moderate Lymph Mode Hyperplasia, reactive moderate Lymph Node (mesenteric) Within normal limits Granuloma Hemorrhage mild moderate marked Group 1 Group 5 Group 6 ----------- ---------------------- DOS SAC DOS SAC DOS SAC 0 0 0 0 0 0 0 0 0 0 9 5 0 0 a 3 1 1 0 1 0 0 0 0 4 9 0 1 d 7 0 1 0 1 0 1 1 0 0 0 1 0 0 0 0 0 3 0 0 4 3 0 0 12 10 0 0 12 10 0 0 0) 0) 0 0 0 0 19) 23) 14 22 0 0 2 1 1 1 1 0 0 0 0 0 0 0 4 0 2 0 1 9 10 0 0 6 6 2 4 1 0 0 0 0 0 5 9 3 4 2 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 6 1 1 1 5 1 0 is 11 0 0 is 10 0 1 0) 0) 0 0 0 0 14) 29) 14 21 0 1 0 2 0 0 0 1 0 1 0 1 0 0 1 0 1 0 0 9 4 0 1 a 0 0 2 1 1 0 1 0 1 n 2 0 0 0 2 0 0 0 0 0 0 1 0 1 0 0 0 1 0 1 0 0 3 0 0 0 3 0 0 is 20 7 q 11 12 0 0 1) 1) 1 1 1 1 0) 0) 0 0 0 0 0 0 0 0 0 0 0 0 Titles: Grou;) I CONTROL 0 ppm Group 5 FC-143 333 ppn Group 6 FC-143 30 ppm Total Examined DOSs Unscheduled Death(s) SACs Protocol Scheduled Sacrifice(s) 15 4 Microscopic Incidence Page: 29 Non-MeoplasticIncidence for Females (continued) Riker Laboratories.Inc. 3M FC-143: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0281CROO12 Species: Rat Table: 8 Tissue/ Diagnosis/ Modifier Lymph Node (,nesenteric()continued) Pigment, brown minimal mild moderate Sinusoidal ectasia moderate marked Mammary Gland Within norinallimits Fibrosis mild Galactocele Lobular hyperplasia moderate Ovary Within normal limits Cyst Tubular hyperplasia mild moderate marked Pancreas Within normal limits Acinar atrophy minimal mild moderate marked Cyst Edema moderate Hyperplasia,islet cell mild Pancreatitis,chronic moderate Polyarteritis minimal Parathyroid Within normal limits Group I Group 5 Group 6 --------------------------------- DOS SAl.' DOS SAC DOS SAC 0 0 0 1 1 0 23) 4 0 0 5 4 1 25) 19 3 0 0 0 0 24) 22 0 0 0 0 0 0 0 3 0 (1 0 0 0 0 5) 5 0 0 0 0 0 0 0 23) 9 0 0 4 3 0 23) 17 3 0 0 0 0 25) 16 6 1 2 3 0 1 0 0 0 0 0 0 0 0 0) 0 0 5 0 1 0 2 0 2 0 2 0 1 0 1 17) 27) 7 9 0 1 0 1 2 1 2 1 2 0 18) 29) 11 16 0 5 7 8 0 2 6 6 1 0 19) 23) is 24 2 0 1 2 1 0 0 0 0 0 0 1 0 1 3 0 1 0 1 1 0 1 0 0 0 0 0 9) 14) 9 14 0 0 0 0 0 0 0 0 0 0 0 0 0 0 23) 22) 4 7 0 u 0 0 7 2 2 1 0 0 25) 24) 23 11 2 7 0 7 0 1 0 6 0 0 22) 21) 18 17 3 2 1 1 1 0 0 1 1 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 1 0 1 15) 15) 15 is Titles: Group 1 CONTROL 0 ppn Group 5 FC-143 300 ppm Group 6 FC-143 30 ppm Total Examined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 15 5 Microscopic Incidence Page: 30 Non-NeoplastiIcncidencefor Females(continued) RikerLaboratories,Inc. 3M FC-143:Two Year OralToxicity-OncogeniciSttyudy in Rats Project Number: 02'UICROO12 Species: Rat Table: 3 Tissue/ Diagnosis/ Modifier Group I Group 5 Group 6 --------------------------------- DOS SAC DOS SAC DOS SAC Pituitary Within nornal limits Cyst Hemorrhage marked Necrosis moderate Salivary Gland Within normal limits Sialadenitis,chronic mild moderite Skii Within normal limits Acanthosis mild Pododem.atitis,ulcerative marked Ulcer moderate marked Small Intestine Within normal limits Edema mild Granuloma Ulcer marked Spinal Cord Within normal limits Malacia moderate Spleen Within normal limits Hematopoiesis,extramedullary, increased mild moderate marked Hemosiderosis minimal mild moderate 22) 24) 5 7 0 0 1 0 1 0 1 0 1 0 19) 24) 13 24 1 0 0 0 1 0 3) 3) 0 0 0 1 0 1 0 0 0 0 2 0 1 0 1 0 24) 25) 24 25 0 0 0 0 0 0 0 0 0 0 2S) ( 23) 23 23 1 0 1 0 25) ( 25) 4 11 7 2 1 1 4 1 2 0 12 13 0 0 8 13 1 0 21) 29) 7 7 0 0 0 0 0 0 0 0 0 0 15) 25) 15 23 0 2 0 0 0 2 2) 0) 0 3 0 0 0 0 1 0 1 0 0 0 0 0 0 0 19) 29) 17 28 1 0 1 0 0 1 0 0 0 0 21) 29) 21 29 0 0 0 0 21) 29) 12 23 2 1 1 0 1 0 0 1 7 5 0 1 6 3 1 1 23) 24) 3 4 0 1 0 0 0 0 0 0 0 0 22) 24) 22 23 0 1 0 1 0 6) 4) 2 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1) 1) 0 0 0 0 0 0 0 0 1 0 1 0 0) 0) 0 0 0 0 0 0 24) 23) 10 17 11 5 5 2 4 2 2 1 2 1 0 0 0 1 1 0 Titles: Group I COT:TROL 0 Ppn. Group 5 FC-143 300 ppm Group 6 FC-143 30 ppm Total Examined DOS= Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 15 6 Microscopic Incidence Page: 31 Won-Neoplastic Incidence for Females (continued) Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Number: 0231CROOIZ Species: Rat Table: 5 Tissu@/ Diagnosis/ Modifier Spleen (continued) Hemosiderosis marked Stomach Within normal limits Edema moderate Hemorrhage nild moderate Mineralization mild necrosis r.iIid moderate Ulcer mild Thyroid Within normal limits Follicular hyperplasia, cystic mild Hyperplasia, C cell mild Ultimobranchial cyst Trachea Within normal limits Urinary Bladder Within normal limits Calculus Epithelial hyperplasia, papillary marked Epithelial hyperplasia, simple mild mod-3rate Hypertrophy mild Uterus Within normal limits Cystic glands minimal mild moderate Group I Group 5 Group 6 ---------------------- ----------- DOS SAC DOS SAC DOS SAC 0 0 25) 25) 20 25 0 0 0 0 1 0 0 0 1 0 1 0 1 0 2 0 1 0 1 0 1 0 0 0 25) 25) 20 23 1 0 1 0 0 0 0 0 2 1 25) 25) 25 25 25) 25) 17 25 1 0 1 0 1 0 7 0 6 a 1 0 0 0 0 0 25) 25) 21 17 2 s 0 0 0 1 2 1 0 0 1 0 20) 29) 25) 24) 13 29 20 24 2 0 2 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 4 0 0 0 2 0 15) 26) f 23) 22) 14 22 22 21 0 0 0 0 0 0 0 0 1 2 1 0 1 2 1 0 0 2 20) 25) 0 1 24) 23) 23 25 24 23 16) 26) 25) 22) is 25 22 22 0 0 0 0 0 0 0 0 0 0 0 0 0 1 2 0 0 1 2 0 0 0 0 0 0 1 0 0 0 1 19) 29) 0 0 26) 23) 17 24 17 17 1 4 7 5 0 1 0 0 1 2 1 1 0 1 2 1 Titles: Group 1 CONTROL 0 ppm Group 5 FC-143 300 ppm Group 6 FC-143 30 ppm Total Examined DOS= Unscheduled Beath(s) SACA Protocol Scheduled Sacrifice(s) 15 7 - Microscopic Incidence Page: 32 Non-Neoplastic Incidence for Females (continued) Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Number: 0231CROO12 Species: Rat Table: 8 Tissue/ Diagnosis/ .4odifier Uterus (continued) Cystic glands marked Hydrometra marked Hyperplasia, endometrial M3derate Group 1 Group 5 Group 6 ---------------------- ----------- DOS SAC DOS SAC DOS SAC 0 3 0 1 0 1 0 0 0 0 0 0 1 0 1 0 0 0 0 0 4 3 0 0 0 0 0 1 0 1 Titles: Group 1 CONTROL 0 ppm Group 5 FC-143 300 pp"i Group 6 FC-143 30 ppm z Total Examined DOS- Unscheduled Death(s) SAC= Protocol Scheduled Sacrifice(s) 15 8 Microscopic Incide-icePage: 33 Project Neoplastic Incidence for Males Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Number: 0281CROO12 Species: Rat - One Year Interim Table: 9 Tissue/ Diagnosis/ Modifier Skin Keratoacantho,,na Group 1 G@roup s ----------- ----------- 0) 1) 0 1 Titles: Group I CONTROL 0 ppm Group 5 FC-143 300 ppm Total Examined 159 Microscopic Incidence Page: 34 Neoplastic Incidence for Females Riker Laboratories.Inc. 3M FC-143: Two Year Oral Toxicity-OncogenicitYSlUdy in RatS - One Year Interim Table: 10 Project Number: 0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Ma-xnary Gland Fibroadenoma Pituitary Adenoma Group 1 Group 5 ----------------------- ( 15) 0 ( 15) 1 ( 13) 2 ( 14) 0 Titles: Group I CONTROL 0 ppm Group 5 FC-143 300 ppm Total Examined 16 0 Microscopic Incidence Page: 35 NeoPlastic In-@ide-icefor Males Riker La5aratories, Inc. 311 FC-il'-!T:wo Year Ora'iToxicity-Oncogenicity Study in Rats Project Number: 3281CR^0212 Species: Rat Table: 11 Tissue/ Diagnosis/ Modifier Adrenal Carcinoqa, cortical Ganglioneurama Pheochronocytoma, benign Pheo:hromocyl.o.Tidm,alignant He.,lolymphoreticularneop'lasn present Bone Marrow Hemolymphoreti@-ular neoplasm present Brain Astrocytoma, berign Oligodendroglioma. benign Hemolymphoraticular neoplasm present Eye Hemolymphorellicular neoplasm present Heart Henoly,.nphoreticularneoplasm present Kidney He,iolymphoreticular neoplasm present Liver Hepatocellular carcinoma Henolymphoreticular neoplasm present Lung Hemoly-.iphoreticularneoplasm present Ly,-iphNode (abdovinal) Hef-,volymphoreticulanreuplasm present Lynph Node (,Tiesenteric) Hemangiosarco.ma Hemolymphoreticular neoplasm preseril Pancreas Aden.z@carcinoma Islet cell adenoma Hemoly,.nphoraticularneoplasm present Parathyroid Adenoma Pituitary Adeno-.ia Salivary Gland Carcinoma Skin Fibroma Fibrosarcoma Group 1 Group 5 Group 6 ---------------------- ----------- DOS SAC DOS SAC DOS SAC 15) 1 0 I 0 0 15) 0 16) 0 1 0 ( 12) 11 (15) 1 16) 1 15) 2 2 16) 3 0) 0 12) 0 1 13) li 0 1 6) 0 15) 6 12) 0 8) 1 1 34) 1 0 1 0 1) 32) 0 34) 1 0 0 33) 0 21) 0 34) 0 .14) 1 1 34) 1 0) 0 3,1) 0 0 33) 0 1 0 16) 0 33) 11 32) .3 7) 0 0 6) 44) 0 0 0 1 0 4 0 0 1 0 6) 42) 1 0 6) 0 0 0 0 1 0 6) 44) 1 0 6) 41) 0 0 ( 5) 44) 1 0 ( 6) 4.) 1 4 1 1 ( 6) ( 44) 1 0 ( 1) ( 0) 1 0 ( u) ( 44) 0 1 1 0 6) ( 43) 0 1 0 1 0 0 5) ( 31) 0 2 5) ( 41) 2 11 5) ( 41) 1 0 0) ( 2) 0 i) 0 0 14) ( 36) 0 0 0 3 0 4 0 1 u 0 0) ( 0) 0 0 0) ( 1) 0 1 1-1 n 0 0 2) ( 3) 0 0 le,) 36) 0 0 14) 36) 1 0 14) 36) 1 0 1 0 14) 36) 1 0 1) 3) 1 3 0) 1) 0 0 0 0 12) 34) 3 1 0 1 0 0 7) 2)) 0 0 13) ( 34) 9 3 10) ( 31) 0 0 5) ( 4) 0 0 2 1 Titles: Group 1 CONTROL 0 PPm Group 5 FC-143 303 Ppm Group 6 FC-143 30 PPm Total Examined DOS= Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 16 1 Microscopic Incidence Page: 36 Neoplastic Incidence for Males (continued) Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in RatS Project Number: 02BlCROO12 Species: Rat Table: 11 Tissue/ Diagnosis/ Modifier Skin (coitinued) Keratoacantho.m., Liposarcoma Papilloma Hemolymphoreticular neoplas-,ipresent Small Intestine Hemolymphoreticular neoplas-ipresent Soft Tissies (abdomen) Fibroma Soft Tissues (thorax) Histiocytoma, malignant Spleen Hemangiosarcoma Hemolyniihoreticular-ieoplasipresent Stomach Adenocarcinona Henolymphoreticular neoplasm present Testis/Epididymis Leydig cell adenomi Thymus He-,iolymphoreticularneoplasm present Thyroid C cell ade-ioma C cell carcinoma Follicular adenoma Urinary Biadder Hemolymphoreticular neoplasm present Hemalymphoreticular System ',#affected] Malignant lynphoma, lymphocytic Malignant lymphona. histiocytic Leukemia, myeloid Group 1 Group 5 Group 6 ---------------------- ----------- -DOS SAC DOS SAC DOS SAC 1 2 1 0 0 1 1 0 IA,) 31) 1 0 0) 0) 0 0 0) 3) 0 0 (16) ( 34) 0 1 1 1 (15) ( 33) 0 0 1 0 (16) ( 33) 0 0 1) 0) 1 0 12) 31) 0 0 0 2 0 0 13) 33) 1 0 3'j' 1] 0 3 1 0 0 0 1 0 0 0 0 .1) 0 0 0 0 0 0 0 0 1) 6) 44) 1) 0) 1 0 0 3 0) 0) 0 0 0) 1) 0) 1) 0 1 .11)) 0) 0 1 0 0 6) 4t) ( 14) 36) 0 0 0 0 1 0 1 0 6) 44) ( 14) 36) 0 1 0 0 0 0 0 0 6) 44) ( 14) 36) 0 7 0 2 1) 1) 1 0 r) 42) 1) 0) 1 0 12) 35) 0 4 1-) 0 0 2 0 0 0 0 1 6) 44) 14) 35) 1 0 0 1] 1) r 13 E 03 1 1 1 0 0 0 0 0 0 0 1 ol Titles: Group 1 CONTROL 0 ppm Group 5 FC-143 300 ppm Group 6 FC-143 33 ppm Total Examined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 16 2 Microscopic Incidence Page: 37 Neoplastic Incidence for Fenales Riker Laboratories. Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Ijumber:0291CROO12 Species: Rat Table: 12 Tissue/ Diagnosis/ Modifier Adrenal Ad-?,voma,cortical Carcino-ia,cortical Pheochromocyto,ia, benign Pheochromocytoma, malignant Hemolymphoreticular neoplasm present Aorta Hemolynphoreticular neoplasm present Bone Marrow Hemolymphorellicular neoplasm present Brain Oligodandroglioma, benign Esophagus Hemoly-.iplioreticulanreoplasm present Eye Hemolynphoretic--llarneoplasm present Hardzrian Gland Adenocarcinoma Heart Hemoly.mphor3ticularneoplasm present Kidiey Henolymphoreticular neoplasm present Large Intestine He-,ioly,.iphoreticulnaeroplasm present Liver Hepatocellular carcinoma Hen,)Iy,-tphoreticulanreoplasm present Lung He.molynphoreticular neoplas:n present Lymph I!ode(mesenteric) He-nolymphoreticular neoplasm present Lyriphflode(thor3cic) He.nolymphoreticular neoplasm present Mammary Gland Adenocarcinoina Adenona Carcinomd Fibroadenona Lympha!igiosarcoma Hemolymphoreticular neoplasm present Group 1 Group 5 Group 6 --------------------------------- DOS SAC DOS SAC DOS SAC 25) 25) 20) 29) 25) 21) 0 0 0 1 0 1 0 0 0 0 1 0 0 2 0 0 0 1 0 0 1 0 0 0 2 0 0 0 0 0 (21) 23) 19) 27) 0) 0) 2 0 0 0 0 0 (25) 2c,) 21) 29) 0) -@) 2 0 0 0 0 0 (25) 25) 21) 29) f)) 0) 0 1 0 0 0 0 (15) 21) 9) 15) 23) 211) 1 0 0 11 0 0 20) 23) l@i) 28) 2) 1) 1 0 0 0 0 0 0) 0) 0) 0) 1) @)) 0 0 0 0 1 0 25) 25) 21) 21) 26) 24) 1 0 0 0 1 0 25) ( 2-'-) (21) ( 29) (26) ( 24) 3 0 0 0 i 0 114)( 23) (17) ( 29) ( 0)( 0) 1 0 0 ri 0 251,( 26) (21) ( 29) (1,5)( 24) 0 0 0 1 0 0 5 0 1 0 1 25) 25) (21( )29) 26) ( 24) 5 0 1 0 19) 23) (14) ( 29) 1 0 0) ( 0) 3 0 0 0 0 o 0) 0) ( 0)( 3) 11) 0 0 0 1) ( 0) 1 0 ?3) 23) (17) ( 27) 23) ( 2) 3 2 3 9 2 1 0 0 0 0 1 6 4 0 0 5 16 0 0 0 11 0 0 1 0 0 0 2 0 0 0 0 0 Titles: Group 1 COTITROL 0 ppm Group 5 FC-143 300 ppm Group 6 FC-1@3 30 ppm Total Examined DOS= Unscheduled Death(s) SACA Protocol Scheduled Sacrifice(s) 16 3 Microscopic Incidence Page: 3C Neoplastic Incidence for Females (continued) Riker Laboratories, Inc. 3M FC-"43: TWD Year Oral Toxicity-Oncogenicity Study in Rats Project Nu.-.iber0:23*.CRDjl2 Species: Rat Table: 12 Tissue/ Diagnosis/ tlodifier t-lesentery Mesothalioma, malignant Henolymphoreticular neoplasm preseit Ovary Grar.:.-loscaell tj-.ior,benig.-, Lr=io-iyo.-.iz Tubilar adeiioma He,iolynphoreti@-ularneoplasm present Pancr2as Islet cell adeiama Islet cell carcinaia He,-iiolymphoraticulanreoplas-. present Pitjitary Adenona S@in Fibroma Fibrosarco.-ia Snail Intestine Lei onyosarcoria Spinal Card Henolymphoreticula.r neoplas-ipresent Spleen He-noly,iiphoreticulanreoplasm present Stonach Henoly-nphoreticular neoplasm present Thyroid C cell adeno-na He,-ioly,-.iphoreticunleaorplasm present Unidentified Tiss:je L ipo,.na Urinary Bladder He.-nolymphoreticularneoplasm present Uterus Ade.iona Heffiangio."ia Leio-iyona Polyp Hemoly,.iphoreticularneoplasm pres,--nt Henolynphoreticular System [f affected) [4alignantlyriphoma,histiocytic Maligi3nt ly-.nphor.1lay,npho.^ytic Group I Group 5 Group 6 ---------------------- ----------- DOS SAC DOS SAC DOS SAC 'J)( 0) 0 i 25) (2T.) 0 3 4 2 0 24) 25) 0 1 I'll 1 2 r, 22) 24) 15 17 3) 3) 1 2 0 0 (24) 25) 0 3 (25) 23) 1 0 (25) ( ZIS) 3 0 (25) ( 25) 1 0 (25) ( 25) 3 1 2 0 0) 0) 0 0 25) 25) 1 0 25) 25) 0 1 c 0 0 i 1 1 2 0 5] r 2 0 3 0 ( 3) 0) 0 0 0 29) i; 0 3 0 0 1 3 0 (19) ( @19) 0 1 0 1 0 0 (21) ( 29) 14 2z 2) .0) 1 0 1 0 18) 29) 0 ( t'l) 29) 0 (21) ( 20) 3 0 (20) ( 29) 0 0 (15) ( 1-@i) 0 0 0 u 1) .3) 1 1 16) 25) 1 l@) 29) li 0 3 0 0 0 1 0 0 rL 1 0 0 0 ( 2) 1 1 2L) 0 3 0 1 22) 1 0 1 23) 20 C-) 0 24) 1 D 3 0 Lll) 0 0 0 2e,) le, 4 1 1 i 1) 1) 1 0) 0) 0 0 24) 23) 1 0 25) 2-;) c 0 23) 22) 0 0 0 0 0) 0) 0 0 25) 26@) 1 0 26) M3) 0 1 c 0 1 2 1 0 1 0 c 0 Titles: Grojp 1 CO:JTROL J ppm Group 5 FC-1-:@ 3'JJppm Group 6 FC-143 30 ppn Total Exanined DOS= Unscheduled Death(s) SAC, Protocol Scheduled Sacrifice(s) 16 4 @licroscopic 1-icid2nce Pa3e: 3-1- SummarizedSingleTabulatedAnimalReport IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3M FC-143:Two Year Oral Toxicity-UncoginicitSytudy in Rats - One Year Interim Table: I ------------ ------ -------------------------------- --- -- Animal Number: IR-3516 Sex: Male Group: 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Lung Lymph Node (sesenteric) Pancreas Parathyroid SmallIntestine Thyroid -No visiblelesions. -Chronicprogressivenephropathy,sild -Yascularmineralizationm,inimal -Not examined,missing -Acinaratrophy,mild -Not examined,missing -Withinnoreillimits Fewer thin protocol number -Not examined,missing The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCord, Bone Narrow,Spleen,Liver,Heart,Stomach,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,MammaryGland,Pituitary,Adrenal,Trachea, Esophagus,SalivaryGland, Eye. --------------------------------- - --- --- - -------------------- Animal Number: IR-T.517 Sex: Male Group: 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Lung Parathyraid Thyroid -No visiblelesions. -Chronicprogressivenephropathy,minimal -Yascularmineralizationm,ild -Not examined, missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, Bone Narrow,Spleen,Liver,Heart,Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aarti,Testis/EpididysisP,rostate,MammaryGland,Pituitary, Adrenal,Trachea,Esophagus,LymphNode (wsenteric),Pancreas,SalivaryGland,Eye. ----------------------------------------------------------------------------------------- Animal Number: IR-3520 Six: Nale Group: 1 1) CONTROL 0 pps Fate: (Weeks 53) 1 Year InterimSacrifice MicroscopicObservations: MicroscopicObservations: Adrenal Kidney -------------------------------- - -No visiblelesions. -Sinusaidaelctasia,cortex,bilateral, moderate -Chronicprogressivenephropathy,minimal Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 1 16 5 SummarizedSingleTabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3H FC-143: Two Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table:I -------------------------------------------------------------------------------------- Animal Number: IR-3520 Sex: Kale Group: ( 1) CONTROL 0 ppe Fite: (Weekz 53) 1 YearInterimSacrifice MicroscopicObservations(continued): Liver Lung LymphNode (sesenteric) Parathyraid Pituitary -kepatocytealteration,vicualated,focal, minimal -Yasculirmineralizationm,inimal -Not examined,missing -Not eximined,not in planeof section -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, Urinaryglidder,Aarti,Testis/EpididysisP,rostate,Thyroid,Trachea,Esophagus,Pancreas, SalivaryGland, Eye. ----------------------------------------- ---- ----------------------------------------- Animal Number: IR-3522 Sex: mile Group: 1 1) CONTROL 0 ppe Fate: (Weekz 53) 1 Year InterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Kidney Liver Lung Parathyroid Thyroid -Light(pale)tan in color. -Chronicprogressivenephropathy,minimal -Portalsononuclearcall infiltrate,minimal -Yascularmineralizations,ild Hemorrhage,oultifocal,mild Perivisculamrnanuclearinfiltratem,ild -Not exiiiinedm,issing -Not examined,missing The followingtissueswere foundto be withinnormal limits: Brain,SpinalCord, Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididymisP,rostate,MammaryBland,Pituitary,Adrenal,Trachea, Esophagus,Lymph Node lsesenteric),Pancreas,SalivaryGland, Eye. ------------------------------ -------------------- ------------------------------------- Anisil Number: IR-35'47 Sex: Halt Group: ( 1) CONTROL 0 ppe Fate: (Weekz 53) 1 Year InterimSacrifice MicroscopicObservations: MicroscopicObservations: Liver Lung -No visiblelesions. -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild -Hemorrhage,oultifocal,mild The followingtissueswere foundto be withinnormallimits: Brain,Spinal Card,BoneNarrow,Spleen,Kidney,kirt, Stomach,SmallIntestine, - ------------------ - -------------- ---- ------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 2 16 6 SummarizedSingleTabulatedAnigalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3H FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table:I - ----------------------------------------- -------------- --------------- Animal Number:IR-3527 Sex: Male 6roup: 1 11 CONTROL 0 ppe Fate: (Neekz53) 1 Year InterimSacrifice MicroscopiOcbservations(continued): The followintgissueswerefoundto be mithinnormal-limit(scontinued): LargeIntestineU,rinaryBladder,Aorta,Testis/EpididyiiPsr,ostate,PituitaryA,drenil, Thyroid,ParithyraidT,rachea,Esophagus,LymphMode (sesenteric)P,ancreas,Salivary61and,Eye. -- ------------------------------------------------------------------------------------------ Animal Number:IR-3535 Sex: Halt 6roup: ( 1) CONTROL0 pps Fate:(Week= 53) 1 Year InterimSacrifice MacroscopicObservations: Nesentary MicroscopicObservations: Lung Resentary Parithyroid Thyroid -Areaa4 fit necrosis,2 s 3 x 0.5 ce. -Alveolareacrophagtso,ulti4ocals,ild i.@tellectisisf,ocal,mild -Necrosis,fit,marked Steatitis,chronic,moderate -Not examined,missing -Not examined,missing The followingtissuesmerefoundto be mithinnormallimits: Brain,SpinalCord,Done Narrow,Liver,Kidney,Heart,Stomach,SmallIntestine, LargeIntestineU,rinaryBladder,Aorta,Testis/EpididymiPsr,ostate,PituitaryA,drenal, Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBlind,Eye, Spleen. ------------------------------------------------------ ------- --- -- ------------------- Animal Number:IR-3543 Sex: Hall 6roup: ( 1) CONTROL0 ppa Fate:(Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung -No visiblelesions. -Chronicprogressivenephropathy,minimal -Portalmanonucleacrell infiltrates,ild Portalbileductproliferatiofno,cal, minimal -Yascularmineralizationm,inimal The followingtissueswerefoundto be withinnormalIisits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stoma-ch,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,PituitaryA,drenal,Thyroid,Parathyroid, Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBlind,Eye. ----------------------------------------------------------------------------------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 3 167 Sumarized SingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations Riker LaboratoriesI,nc. 3H FC-143: Two Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table:I -------------- - --------------- -- Animal Number:IR-3546 Sex: Nale Group: 1 1) CONTROL0 pps Fate: (Week=53) 1 YearInterimSacrifice MicroscopicObservations: MicroscopicObservations: Adrenal Liver Lung Stomach -No visiblelesions. -Nodularhyperplasiac,ortex,unilateral, moderate -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiomni,ld Nepatocytaelterationv,acualatedo,ultifocal, mild -Perivasculamrnonuclearinfiltrates,ild -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Kidney,Heart,Small IntestineL,arge Intestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,PituitaryT,hyroid,ParathyraidT,rachea, Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. -------------------------------------------------------------------------------------- AnisalNumber: IR-3550 Sex: Male Group: 1) CONTROL 0 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: Kidney MicroscopicObservations: Heart Kidney Liver Lung Pancreas -Bilateralhydronephrosis -Myocarditisc,hronicnonsuppurativef,ocal, mild -Hydronephrosisb,ilateral,moderate Calculus,pelvic -Portalsonanucleacrell infiltratem,ild -Yascularsineralizatiosni,ld -Acinaratrophy,focal,moderate Pancreatitisc,hronic,focal,sild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Spleen,Stomach,Small IntestineL,arge Intestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,PituitaryA,drenal,Thyroid,Parithyroid, Trachea,Esophagus,LymphNode (sesenteric)S,alivaryBland,Eye. ------------------ ------------------------------------ -- -- ------------------------ Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 4 166 SummarizedSingle TabulatedAnimal Report icontinved) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3H FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table:I - --------- - - -------------------------- ---------------- AnimilNumber: IR-3551 Sex: male Group: 1 1) CONTROL0 pps Fate:(Weekz 53) 1 YearInterimSacrifice MicroscopicObservations: Liver MicroscopicObservations: Liver Lung -paletan -Portalsononucleacrellinfiltratem,ild Portalbileductproliferatiomni,ld -Pneumoniai,nterstitialc,hronic,focal,mild Hemorrhageo,ultifocalm,ild Hyperplasias,eptalcell,focal,sild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, LargeIntestineU,rinaryBladder,Aorta,TestislEpididysiPsr,ostate;PituitaryA,drenal, Thyroid,ParathyraidT,rachea,Esophagus,Lymph Node (sesenteric)P,ancreas,SalivarySlind,Eye. ---------------------------------------------------------------------------- --- Animal Number:IR-3559 Sex: Halt Group: 1) CONTROL 0 ppe Fate:(Week= 53) 1 Year InterimSicrifice MicroscopicObservations: MicroscopicObservations: Kidney Liver Lung -No visiblelesions. -Pyelitisi,cute,bilateralm,inimal Rephritisi,nterstitiaclh,ronic,focal, unilateralm,ild -Portalsononucleacrell infiltratem,ild Portalbileductproliferatiovni,ld -Hemorrhageo,ultifocils,ild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,Small IntestineL,argeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parithyroid, Trachei,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBlind,Eye. ------------------------------------------------------------------------------------- Animal Number: IR-3568 Six: Nale Group: 1 1) CONTROL0 ppe Fate: (Week= 53) 1 YearInterimSacrifice MicroscopicObservations: -No visiblelesions. MicroscopicObservations: Kidney -Chronicprogressivenephropathy,mild Pancreas -Pinertititicsh,ronicf,ocil,mild Acinaratrophy,focal,sild Pirathyraid -Notexamined,not in planeof section ------------------------------------------------------------------------------------- Species:Rat ProjectNumber: 0291CROO12 SummarizedSTAR Page: 5 16 9 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3H FC-143:Two Year Oral Toxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I ------ ------------------- --------- --- ---------- - --------------------------- Animal Number: IR-3568 Sex: Kale Group: ( 1) CONTROL 0 ppe Fate: (Veekz 53) 1 Year InterimSacrifice MicroscopiOcbservations(continued): The followingtissueswere found to be within normal 117@its: Brain,SpinalCard, BoneKarroo,Spleen,Liver,Heart,Lung, Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Pituitary,Adrenal, Thyroid,Trachea,Esophagus,Lymph Node (sesenteric),Salivary61and,Eye. -- ----------------------------------------------------------------------------------------- Animal Number: IR-3570 Set: Male Group: ( 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Lung Parathyraid -No visiblelesions. -Corticalvacualationo,ultifocal,sild -Pneumonia,interstitialc,hronic,focal, minimal Hemorrhage,oultifocal,sild -Not examined,not in plane of section The followingtissueswere foundto be within-norailimits: Brain,SpinalCord, Bone Narrow,Spleen,Liver,Kidney,Heart,Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta, Testis/EpididysisP,rostate,Pituitary,Thyroid, Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,Salivary61&nd, Eye. --------------------------------------------------- ---------- Animal Number: IR-3575 Sex: Halt Group: 1 1) CONTROL 0 pps Fate: (Neekz 53) 1 Year InterimSacrifice MacroscopicObservations: @ SoftTissues(leg) MicroscopicObservations: Kidney Lung Pituitary -Soollenlefthind4cotat the hock joint. -Chronicprogressivenephropathy,minimal -Yascularmineralizitionm,inimal AlveolarBacrophageso,ultifocal,mild Hemorrhage,focal, mild -Cyst,pars distalis The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Marro*,Spleen,Liver,Heart,Stomach, Small Intestine, LargeIntestine,UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Adrenal,Thyroid, Parathyroid,Trachea,Esophagus,LymphNode (nesenteric),Pancreas,Salivary61&nd, Eye. --- --------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Swearized STAR Page: 6 170 SummarizedSingle TabulatedAnimal Report (continued) Individuallucroscopicand MicroscopicObservations RikerLaboratories,Inc. 3H FC-143: Too Year Oral Toxicity-OncoginicitSytudy in Rats - One Year Interim Table: I ------------------------------------------------------------------------------------------ Animal Number: IR-3580 Sex: Male Group: 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: Kidney MicroscopicObservations: Bone Narrow Kidney Lung Pancreas Parathyroid Spinal Cord -Darkcysticlesion,0.4 ce dia.,left. -Not examined,missing -Chronicprogressivenephropathy,sild Cyst,cortical,unilateral -Alveolarmicrophages,oultifocal,mild Pneumonia,interstitialc,hronic,oultifocal, mild -Pancreatitisc,hronic,focal,sild -Not examined,not in plane of section -Not examined,missing The followingtissueswere foundto be withinnormal limits: Brain,Spleen,Liver,Heart,Stomach,SmallIntestine,Large Intestine,UrinaryBladder,Aorta, Testis/EpididysisP,rostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, Lymph Node @sesenteric),SalivaryGland, Eye. --------------------------------------------------------------------------------------------- Animal Number: IR-4579 Sex: Female Group: ( 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Lymph Node (sesenteric) Parathyroid -No visiblelesions. -Pelvicmineralizationm,inimal -Not examined,missing -Not examined,not in plane of section The followingtissues*ere found to be withinnormallimits: Brain, Spinal Card, Done Narrow, Spleen,Liver,Heart,Lung, Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,MammaryGland,Pituitary,Adrenal, Thyroid,Trachea,Esophagus,Pancreas,SalivaryGland, Eye. ------------------------------------------------------------------------------------------ Animal Number: IR-4582 Sex: Female Group: ( 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: Nesentary -Yellownodularmass, I x 0.5 ca. MicroscopicObservations: Heart -Nyocarditis,chronicnonsuppurativef,ocal, minimal Kidney -Calculus,pelvic,unilateral -------------- - ------ ----------------------------------------------------- ---------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 7 71 SummarizedSingle TabulatedAnimal Report (continued) IndividualNacroscapicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:TitoYear Oral Toxicity-WcogenicityStudy in Rats - One Year Interim Table:I - ---------- Animal Number: IR-4582 Sex: Female Group: 1) CONTROL 0 ppe Fate:(Neekz 53) 1 YearInterimSacrifice MicroscopiOcbservations(continued): LargeIntestine Lung Resentary Parathyraid UrinaryBladder Uterus -Not examined,missing -Pneumoniai,nterstitiaclh,ronic,sultifocal, mild Hemorrhage,localareas,mild Perivasculasrononucleairnfiltratem,ild -Necrosis,fat, nodular,moderate Steatitis,chronic,moderate -Notexamined,not in planeof section -Not examined,missing -Hyperplasiag,landularepitheliums,ild Metaplasia,squamous,glandular,mild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Spleen,Liver,Stomach,SmallIntestine,Aorta,Ovary, MammaryGland,Pituitary,Adrenal,Thyroid,Trachei,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------------- Animal Number:IR-4585 Sex: Feeale Group: 1 1) CONTROL0 ppe Fate: (Week=53) 1 Year InterimSacrifice MicroscopicObservations: MicroscopicObservations: Adrenal Kidney Liver Lung Parathyraid -No visiblelesions. -Sinusoidaelctasia,cortex,focal,unilateral, mild -Pelvicsintralizatiomni,nimal -Portalsononucleacrellinfiltratem,inimal -Yascularsineralizationm,ild Hemorrhages,ultifocal2,ild -Notexamined,not in planeof section The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Done Narrow,Spleen,Heart,Stomach,Small IntestineL,arge Intestine, UrinaryBladder,Aorta,Uterus,Ovary,HastaryGland,Pituitary,Thyroid,Trachea,Esophagus, LymphNode lsesenteric)P,ancreas,SalivaryBlind,Eye. ------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: B 172 SummarizedSingleTabulatedAnimal Report lcantinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3N FC-143: TNo YearOralToxicity-OncogeniciSttyudyin Rats- One YearInterim Table:I ------------------- ----------------- Animal Number: IR-4588 Sex: Female Group: 1 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MicroscopicObservations: Skin Adrenal MicroscopicObservations: Adrenal Kidney Liver Lung Spinal Cord Spleen -Hair loss,neck. -Left enlarged -Sinusaidalectasia,cortex,unilateral, marked Corticaldegenerationu,nilateral,mild -Hyperpl&5i&,pelvicepithelium,mild Calculus,pelvic,unilateral Cyst, medullary,sild 4epitacytevacuclationo,ultifocalm,ild -Hemorrhage,diffuse,moderate -Not examined,missing -Neeasiderosiss,ild The followingtissueswere found to be withinnormal limits: Brain,Done Narrow,Heart,Stomach,Small Intestine,Large Intestine,UrinaryBladder,Aorta, Uterus,Oviry, MammaryGland, Pituitary,Thyroid,Parathyroid,Trachea,Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryGland,Eye, Skin. -----------------------------------f-------------------------------------------- Animal Number: IR-4599 Sex: Female Group: ( 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: Pituitary MicroscopicObservations: Liver Hameary Bland Parathyroid -Slightlyenlarged -Portalsonanucleacrellinfiltrates,ild Portalbile ductproliferations,ild -salactocele -Not examined,not in plane of section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, Bone Narrow, Spleen,Kidney,Heart,Lung, Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,Pituitary,Adrenal,Thyroid,Trachea, Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 9 173 SummarizedSingleTabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143: Too Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table: I ----------------------------------------------------------------------------------- Animal Number: IR-45qO Sex: Female Group: ( 1) CONTROL 0 pps Fate: (Week= 53) 1 Year InterimSacrifice MicroscopicObservations: MicroscopicObservations: Lung -No-visiblelesions. -Hemorrhage,local areas, moderate The followingtissueswerefound to be mithin normallimits: brain,SpinalCard, Done Narrow,Spleen,Liver,Kidney,Heart,Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,HimearyGland,Pituitary,Adrenal, Thyroid,Parithyraid,Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryGland,Eye. --------------------------------------------------------------------------------------------- Animal Number: IR-4601 Sex: Female Group: ( 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: Kidney MicroscopicObservations: Kidney Liver Lung -Hydronephrosisu,nilateral -Hydronephrosisu,nilateral,moderate Calculus,unilaterals,ild -hepatacytevacuclation,oultifecal.m,inimal -Hemorrhage,oultifocals,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord, Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, Urinary Bladder,Aorta, Uterus, Ovary, Mammary Gland, Pituitary,Adrenal,Thyroid,Parithyraid, Trachea,Esophagus,Lymph Node (mesenteric),Pancreas,SalivaryBlind, Eye. ------------------------------------------------------------------------------------------------ Animal Number: IR-4608 Sex: Female Group: 1 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: Uterus MicroscopicObservations: Liver Lung Lymph Node (sesenteric) Uterus -Left horncysticlookinglesion,I x 0.6 ca. -Hepatocytevacuclation,oultifocal,minimal -Hemorrhage,oultifocal,mild -Not examined,missing -Cysticglands,4ocal, marked The followingtissuesmere found to be withinnormallimits: Brain, Spinal Card, Bone Narrow, Spleen,Kidney,Heart,Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Ovary,Mammary61and,Pituitary,Adrenal,Thyroid, Parathyraid,Trachea,Esophagus,Pancreas,SalivaryGland, Eye. ------------------------------------------------------------------------------------------ Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 10 17 4 SummarizedSingleTabulatedAnimalReport lcantinued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143: Two YearOralToxicity-OncoginiciStyudyin Rats - One YearInterim Table:I ------------ ------------------------ - -------------------------- Animal Number:IR-4610 Sex: Female Group: 1 1) CONTROL0 pp2 Fate:(Neekz 53) 1 YearInterimSacrifice MacroscopicObservations: Pituitary Uterus MicroscopicObservations: Adrenal LargeIntestine Lung Pancreas Parathyroid Uterus -Slightlyenlarged -Sli-ghtleynlarged -Sinusaidaelctasia,cortex,mild -Nesatodiasis -Alveolarsacrophageso,ultifocals,ild -Pancreatiticsh,ronic,focal,mild -Notexamined,not in planeof section -Hyperplasiag,landularepitheliumm,ild Metiplasias,quiscus,glandulars,ild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Spleen,Liver,Kidney,Heart,Stomach,Small Intestine, UrinaryBladder,Aorta,Ovary,Hassiry61&nd,Pituitary,Thyroid,Trachea,Esophagus, LymphNode (mesenteric)S,alivaryGland,Eye. ---------- ------------------------------------------------ --------------------- Animal Number: IR-46410 Sex:Female Group: 1 1) CONTROL0 ppm Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: Eye MicroscopicObservations: Eye Kidney Lung UrinaryBladder -Atrophy,righteye. -Panophthalsitisu,nilateralm,arked Atrophy,unilateralm,arked -Pelvicmineralizationm,inimal -Hemorrhageo,ultifocalm,ild -Not examined,missing The followingtissueswere foundto be Nithinnormallimits: Brain,SpinalCord,Done Narrow,Spleen,Liver,Heart,Stomach,Small Intestine, LargeIntestineA,orta,Uterus,Ovary,MammaryBland,Pituitary,Adrenal,Thyroid,Parithyraid, Trachea,Esophagus,LymphNode (misenteric)P,ancreas,SalivaryGland. --------------------------------------------------------------------------------- Animal Number: IR-4629 Sex: Female Group: ( 1) CONTROL0 pps Fate:(kekz 53)1 YearInterimSacrifice MacroscopicObservations: Skin -Hairloss,head,neck,face. MicroscopicObservations: Adrenal -Corticaldegenerationf,ocal,unilateral, mild ------------------------------------------------------------------------------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 11 17 5 SummarizedSingleTabulatedAnimalReport (continued) Individualmacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FE-143: Two Year Bril Toxicity-UncogeniciSttyudy in Rats - One Year Interim Table:I ------ - --------------------------- ------ ----------------------------------- Animal Number: IR-4629 Sex: Female Group: ( 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MicroscopicObservations(continued): Aorta Large Intestine Liver Parathyroid -Not examined, missing -mesatodiasis -Portalbileductproliferationm,ild -Not examined,not in plane of section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord, Bone Karroo,Spleen,Kidney, Heart,Lung, Stomach,Small Intestine, UrinaryBladder,Uterus,Ovary, HasearyBland, Pituitary,Thyroid,Trachea,Esophagus, Lymph Node (sesenteric)P,ancreas,SalivarySland,Eye, Skin. ----------------------------------------------------------------------------------------- Animal Number: IR-4630 Sex: Feeale Group: 1) CONTROL 0 ppe Fite: (Weekz 53) 1 Year InterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Kidney Liver Lung Parathyroid Thyroid -Possiblyslightlypalein color. -Calculus,pelvic,unilateral,moderate -Hipatocytealteration,vacualated,oultifocal, mild -Hemorrhage,oultifocal,mild -Not,examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain, SpinalCord, Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorti,Uterus,Ovary,MammaryGland,Pituitary,Adrenal,Trachea, Esophagus, Lymph Node (sesenteric)P,ancreas,SalivaryGland,Eye. -------------------------------------------------------------------------------------------- Anisal Number: IR-4631 Sel: Female Group: ( 1) CONTROL0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Lung Lymph Made (sesenteric) Parithyraid Urinary Bladder -No visiblelesions. -Pelvicmineralizationm,inimal -Hemorrhage,local areas,mild -Not examined,missing -Not examined,not in plane of section -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, Done Narrow,Spleen,Liver,Heart, Stomach,Small Intestine, ---------------------------------------------------- ---- - Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 12 76 SummarizedSingleTabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3N FC-143: Two Year Oral Toxicity-OncogenicityStudy in Rats - One Year Interim Table: I --- -------- ------ --- - - ----------------- ------------------------------- Animal Number: IR-4631 Sex: Female Group: ( 1) CONTROL 0 ppe Fate: (Week= 53) 1 Year InterimSacrifice MicroscopicObservations (continued): The followingtissueswere found to be within normal-limits(continued): Large Intestine,Aorta, Uterus, Ovary, Haosary Gland, Pituitary,Adrenal,Thyroid, Trachea, Esophagus, Pancreas, Salivary Gland, Eye. ---------------------------------------------------------------------------------------------- Animal Number: IR-4632 Sex: Female Group: Fate: (Weeks 53) 1 Year InterimSacrifice 1) CONTROL 0 pps Microscopic Observations: Pituitary Mammary Gland Microscopic Observations: Adrenal Kidney Liver Lung Namairy Gland Ovary Pituitary -Slightly enlargedwith a dark red focus an surface. -Small sphericalmass, 1.2 co dia., containing dark red fluid, left inguinal. -Sinusaidalectasia,cortex,focal, unilateral, sild -Chronic progressivenephropathy,mild -Repatocytevacuolation,oultilocal,mild -Hemorrhage, oultifocal, sild -salactocell Chronic inflammationand hemorrhage in cysts. -Cyst, unilateral -Adenoma The followingtissueswere found to be withinnormallimits: Brain, Spinal Cord, Bone Narrow, Spleen, Heart, Stomach, Small Intestine,Large Intestine, Urinary Bladder, Aorta, Uterus, Thyroid, Parathyraid,Trachea,Esophagus, Lymph Made (sesenteric),Pancreas, Salivary Bland, Eye. --------------------------------- -------- ---- -- --- -- ---------------------------------- Animal Number: IR-4640 Sex: Female Broup: ( 1) CONTROL 0 ppe Fate: lheekz 53) 1 Year InterimSacrifice Nacroscapic Observations: Microscopic Observations: Liver Lung Parathyroid -No visiblelesions. -Nepatocytevicualition,oultifocal,minimal -Hemorrhage, sild -Not examined,not in plane of section The following tissueswere found to be within normal limits: Brain, Spinal Cord, Done Narrow, Spleen, Kidney, Heart, Stomach, Small Intestine, Large Intestine,UrinaryBladder,Aorta, Uterus,Ovary, Nanary Gland, Pituitary,Adrenal, Thyroid, Trachea, Esophagus, Lymph Node (sesenteric),Pancreas, Salivary Gland, Eye. ------------- --- -------- ----- -- Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 13 177 SummarizedSingle Tabulated Animal Report IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3H FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table:I ------------------------------------------------------------ --------- Anisal Number: IR-3584 Sex: Male Group: 5) FC-143 300 ppe Fate: (Weeks 53) 1 Year InterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Aorta Kidney Liver Lung Parathyroid -Fal-e -Not examined,missing -Chronic,progressivneephropathy,mild -Portalsononucleiciirllinfiltrates,ild Portalbileductproliferationm,ild Regilocytosis,moderate Necrosis,focal,minimal -Yascularmineralizationm,ild Alveolarsacrophiges,oultifocal,mild -Not examined,not in plantof section The followingtissueswere foundto be withinnormallimits: Brain,SpinilCord, Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Testis/EpididysisP,rostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryBland,Eye. ------------------------------------------------------------ --- ------------------- Animal Number: IR-3508 Six: Mile Group: 5) FC-143 300 ppe Fate: (Neekz 53) 1 Year InterimSacrifice Macroscopic Observations: MicroscopicObservations: Kidney Liver Lung Spleen -No visiblelesions. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,ild Regalacytosis,mild Necrosis,oultifocals,ild -Yascularmineralizationm,ild -Neeasiderasis,mild The followingtissueswere foundto be withinnormal limits: Brain,SpinalCord, Bone Narrow,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Pituitary,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryBland, Eye. ------------------------------------------------------------------------------------------ Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 14 17 8 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143: Two Year OralToxicity-OncoginicitSytudy in Rats- One Year Interim Table: I --- ----- ---- ----- - ----------------------- -------------- -- - -- -- -------------- Animal Number: IR-3589 Sex: Kale Group: 5) FC-143 300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Aorta Liver Lung ParathyrDid Thyroid -No-visiblelesions. -Not examined,missing -Portalmanonucleacrell infiltratem,ild Regalocytosis,mild -Yascularmineralizationm,ild -Not examined,missing -Not examined, missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, Bone Narrow,Spleen,Kidney,Heart,Stomach,Small Intestine, LargeIntestine,UrinaryBladder,Testis/EpididysisP,rostate,Pituitary,Adrenal,Trachea, Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryGland, Eye. ----------------------------------------------------- - --- --- ----------- ----------- Animal Number: IR-3592 Sex: Nale Group: 5) FC-143 300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: Pituitary MicroscopicObservations: Kidney Liver Lung Parathyraid Urinary Bladder -Small dark red @ass, 0.3 cm dia. -Chronicprogressivenephropathy,minimal -Portalmanonuclearcell infiltrate,minimal Nepatacytevacuolation,oultifocal,sild Pigment,Kupfercell,sultifocal,brown,sild -Yascularmineralizationm,ild AlveolarBacrophigeso,ultifocal,mild -Not examined,not in plantof section -Not examined,missing The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCord, Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, Aorta,Testis/EpididysisP,rostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryGland,Eye. ---- -- ---- - ------------- ------- ------- --- ------------- --- --- ------------------- Animal Number: IR-3598 Sex: Kale Group: ( 5) FC-143300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: -No visiblelesions. MicroscopicObservations: Heart -Myocarditis,chronicnonsuppurative, sultifocal,minimal --- - - ----------- - --------- - - ---------------------------- ----- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 15 179 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObw vations RikerLaboratories,Inc. 3H FC-143: Two Year Oral Ti)xicity-OncogeniciStyudy in Rats- One Year Interim Table: I ---------------- -------------------------- ---------- ------------------------- Animal Number: IR-3598 Sex: Male Group: 5) FC-143 300 pps Fate: (Weekz 53) 1 YearInterimSicrifice MicroscopicObservationslcmtinued): Kidney Liver Lung Parathyraid Pituitary -Chronicprogressivenephropathy,minimal -Poftalsononucleacrellinfiltratem,ild Negalacytosis,minimal Necrosis,oultifocal,minimal -Alveolarmacrophages.o,ultifecal,mild -Not examined,not in plane of section -Not examined,missing The followingtissueswere foundto be within normallimits: Brain,SpinalCord, Done Narrow,Spleen,Stomach,Small Intestine,Large Intestine, Urinary Bladder,Aorta, Testis/EpididysisP,rostate,Adrenal,Thyroid,Trachea,Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryGland,Eye. ------------------------------------------ --- ------ --- --------------------------- Animal Number: IR-3604 Sex: Male Group: 5) FC-143 300 ppe Fite: (Week= 53) 1 YearInterimSicrifice MacroscopicObservations: MicroscopicObservations: Aorta Heart Kidney Liver Lung Parathyroid SalivarySland -No visiblelesions. -Not examined,missing -Myocardialfibrosis,focal,mild -Chronicprogressivenephropathy,mild -Portalsonanuclearcellinfiltratea,ild Regalocytosis,minimal Necrosis,oultifocal,mild -Yascularmineralizations,ild Alveolareacrophages,oultifocal,mild Hemorrhage,local areas,sild -Not examined,not in plane of section -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain, SpinalCord, DoneNarrow, Spleen,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Testis/EpididysisP,rostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, Lymph Node (sesenteric),Pancreas,Eye. ---------- -- ------------------------ ---------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 16 180 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143: Two Year OralToxicity-OncogenicitSytudy in Rats - One Year Interim Table:I ------------------------------------------------------------------------------------- Animal Number: IR-3613 Sex: Halt Group: 5) FC-143 300 ppe Fate: lneekz 53) 1 Year InterimSacrifice MacroscopicObservations: Liver Kidney MicroscopicObservations: Eye Liver Lung Parathyraid Testis/Epididysis -Paletan color. -Sailldepressedarea,0.2 ce dia.,right kidney. -Retinalatrophy,focal,minimal -Portalsonanucleacrellinfiltratem,ild' Regalocytosis,minimal -Yascularmineralizations,ild -Not examined,not in plane of section -Tubuleatrophy,ispereatogenesisu,nilateral, marked The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord, Bone Narrow,Spleen,Kidney,Heart,Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Prostate,Pituitary,Adrenal,Thyroid,Trachea, Esophagus,Lymph Mode (sesenteric),Pancreas,Salivarygland. ------------------------------------------------------------- - ---- --------- ------ Animal Number: IR-3617 Sex: Male Broup: 1 5) FC-143 300 ppe Fate: (Weekz 53) 1 Year InterimSacrifice - ---- MacroscopicObservations: Skin MicroscopicObservations: Kidney Liver Lung Lymph Node isesenteric) Skin -Ulceratednodule in the dorsal area,1.5 ce dia. -Mineralizatiosnu,ltifocalc,ortical Pyelitis,acute,unilateralm,ild -Negalocytosis,minimal -Alveolarsicrophages,oultifocal,mild -Hemorrhage, minimal -Keratoacanthoma The followingtissueswere foundto be withinnormal limits: Brain,SpinalCord, Bone Warrois,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta, Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parithyroid, Trachea,Esophagus,Pancreas,Salivary61and, Eye. ----------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 17 181 SummarizSeidnglTeabulatAendimaRleportltantinued) IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratorieIsn,c. 3H FC-143T:woYearOralToxicity-OncoginiSctiutdyyin Rats- OneYearInterim TableI: AnimalNumberI:R-3620 Sex:Halt Group: 5) FC-143300ppe Fate:(leek=53)1 YearInteriSmacrifice MicroscopOibcservations: MicroscopOibcservations: Aorta Kidney Liver Parathyroid -Novisiblelesions. -Notexaminedm,issing -Chronipcrogressinvephropithmyi,nimal -Portaslononucltatrellinfiltratmei,ld HopitDCYtVe&CUDIatiOonu,ltifocamli,nimal Regalocytosimsi,nimal -Notexaminedn,otin planeof section Thefollowintgissue*serefoundto be withinnormallimits: Brain,SpinalCord,Ban#Marrow,SpleenH,eart,Lung,StomachS,mallIntestineL,argeIntestine, UrinarByladderT,estis/EpididysPirso,stateP,ituitaryA,drenalT,hyroidT,racheaE,sophagus, LymphNode(sesenteriPca)n,creasS,alivarGyland,Eye. - ----------------------------------------- -------------- -- --- --------------- AnimalNumber:IR-3622 Sex:Halt Group: 5) FC-143300ppe Fate:(Week=53)1 YearInteriSmacrifice MicroscopOibcservations: Eye Testis MicroscopOibcservations: Eye Kidney Liver Lung LymphNode(sesenteric) Parithyroid Prostate Testis/Epididysis -Oculaorpacityb,ilateral. -Lefttestissmall. -Cataractb,ilateral -Chronipcrogressinvephropithsyi,ld -Portalmanonuclecaerllinfiltratmei,nimal Regalocytosimsi,nimal PigmentK,upiercell,brown,minimal -Vasculamrineralizatimoinn,imal Pneumoniai,nterstitiaclh,ronico,ulti4ocal, sild -Hemorrhagmei,ld -Notexaminedn,ot inplaneof section -Mt examinedm,issing -Tubulaetrophya,spermatogenesuinsi,lateral, marked The followintgissuewserefoundtobe withinnormaliisits: Brain,SpinalCord,loneNarrowS,pleenH,eart,StomachS,mallIntestineL,argeIntestine, UrinarByladderA,orta,PituitaryA,drenalT,hyroidT,racheaE,sophagusP,ancreas, SalivarGyland. ------- ---- - -------------- - -- --- - SpeciesR:at ProjecNtumber0:261CROO12 SummarizSeTdARPage:18 18 2 SummarizedSinglt TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. SH FC-143: Too YearOralToxicity-OncogeniciSttyudyin Rats- One YearInterim Table:I -------------------------------------------------------------------------------------- Animal Number: IR-3626 Sex: Halt Group: 1 5) FC-143300 pps Fate:(Week= 53) 1 YearInterimSacrifice MicroscopicObservations: MicroscopicObservations: Kidney Liver Lung Parithyraid Pituitary Prostate No-visiblltesions. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,ild negalacytosism,inimal -Alveolarsacrophageso,ultifocal,mild -Notexamined,not in planeof section -Not examined,missing -Prostatiticsh,ronicf,ocal,intersititial, minimal The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard.Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiAsd,renal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,Salivarygland,Eye. -------------------------------------------------------------------------------------- Animal Number: IR-3627 Sex: Mile Group: ( 5) FC-143300ppa Fate:(Week=53) 1 YearInterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Liver Lung Parathyroid -Slightlypaletan in color. -Portalsonmuclearcellinfiltratem,inimal -Hemorrhagel,ocalareas,aild -Notexamined,not in planeof section The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, LargeIntestineU,rinaryBladder,Aorta,Testis/EpididysiPsr,ostate,PituitaryA,drenal, Thyroid,Trachea,Esophagus,LymphNode (stsentoric)P,ancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------- Animal Number: IR-36'JB Sex: Kale Group: 5) FC-143300 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: MicroscopicObservations: Liver Lung Lymph Node (sesenteric) - --- ------------------------- -No visiblelesions. -Portalsononucleacrellinfiltratem,inimal Necrosiso,ultifocals,ild -Hemorrhage,local areas,moderate -Not examined,missing Species:Rat Project Number: 0221CROO12 Summarized STAR Page: 19 18 3 SummarizedSingle TabulatedAnimil Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143: Tva Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim --------------------------- --------------- Table: I - ------------------------ Animal Number: IR-3638 Sex: Halt Broup: ( 5) FC-143300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MicroscopicObservationslcontinued): Pituitary Prostate Urinary Bladder -Not examined,missing -Not examined,missing -Not examined,missing The followingtissueswere found to be withinnormallimits: Brain, Spinal Cord, Done Narrow. Spleen,Kidney,Heart,Stomach,Small Intestine, Large Intestine,Aorta,Testis/EpididysisA,drenal,Thyroid,Parathyroid,Trachea,Esophagus, Pancreas,SalivaryGland, Eye. ---------------------------------------------------------------------------------------- Animal Number: IR-3642 Sex: Male 6roup: 1 5) FC-143 300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Large Intestine Liver Lymph Node (sesenteric) Parathyroid Thyroid -No visiblelesions. -Chronicprogressivenephropathy,minimal -Mematodiasis -Regalacytosis,mild -Not examined,missing -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormal limits: Briin,SpinalCord, Bone Narrow,Spleen,Heart,Lung, Stomach,Small Intestine,UrinaryBladder, Aorta,Testis/EpididysisP,rostate,Pituitary,Adrenal,Trachea,Esophagus,Pancreas, SalivaryBland, Eye. ------------------------------------------------------------------------------------- Animal Number: IR-3643 Sex: Nile 6roup: 1 5) FC-143 300 ppe Fite: (Weeka 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Heart Kidney Liver Lung -- ------ -------------------- -No visiblelesions. -Myocardialfibrosis,focil,minimal "yocarditis,chronicnonsuppurativef,ocal, minimal -Chronicprogressivenephropathy,mild -Portalsonanucleacrellinfiltrates,ild Negalocytosis,moderate Necrosis,oultifocal,mild -Yascularmineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, mild Perivascularsonanuclearinfiltrate,mild Species: Rat Project Number: 0261CROO12 Summarized STAR Page: 20 184 SummarizedSingle TabulatedAnimal Report lcontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3N FC-143;Tma Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table: I - ------------------ ---------------- -- --- - --- --- ---------- ---- ---------- Animal Number: IR-3643 Six: Halt Group: ( 5) FC-143300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MicroscopicObservationsicmtinued): Parathyroid -Not examined,not in plane of section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord, Bone Narrow,Spleen,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Pituitary,Adrenal,Thyroid,Trachea, Esophagus,Lymph Node (Besenteric),Pancreas,Salivary61and, Eye. ---------------------------------------------- ---- ---- ---------------------------- Animal Number: IR-4642 Sex: Female Group: 5) FC-143 300 ppe Fate: (deek= 53) 1 Year InterimSacrifice MacroscopicObservations: Eye Uterus MicroscopicObservations: Eye Kidney Large Intestine Liver Parathyraid Uterus -Atrophy,righteye. -Bothhornsenlarged,filledwith clearfluid. -PanophthalBitisu,nilateral,marked Atrophy,unilateral,marked -Chronic progressivenophropathy,mild -Nesitodiasis -Hepatocytovacuclation,sultilocal,mild -Not examined,not in plane of section -Hydrometra,moderate Endoettritisc,hronic,mild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, BoneNarrow, Spleen,Heart, Lung, Stomach,Small Intestine,UrinaryBladder, Aorta, Ovary, MammaryGland, Pituitary,Adrenal,Thyroid,Trachea,Esophagus, Lymph Node (sesenteric)P,ancreas,Salivary61and. --------------------------------------------------------------------------------------- Animal Number: IR-4652 Sex: Female Group: ( 5) FC-143300 pps Fate: lneeka 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Parathyroid -No visiblelesions. -Chronicprogressivenephropathy,sild -Hopitacytevacuolationo,ultifocal,mild -Not examined,not in plane of section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, Done Marron,Splm, Heart,Lung, Stomach,Small Intestine,Large Intestine., UrinaryBladder,Aorta, Uterus,Ovary,Ramary 61and,Pituitary,Adrenal,Thyroid,Trachea, Esophagus,Lymph Node (sesenteric),Pancreas,Salivary61and, Eye. ---------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 21 18 5 SummarizedSingle TabulatedAnimal Report lcantinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FC-143: Two YearOral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table:I --------------- ---------------------- - --------------- -- --------- ------------- Animal Number: IR-4655 Sex: Female Group: ( 5) FC-143300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Aorta Liver Lung Pituitary -ka visiblelesions. - -Not examined,missing -Nepatocytevacualitiono,ultifocal,sild -Hemorrhage,localareas, mild -Not examined, missing The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCord, Bone Narrow,Spleen,Kidney,Heart,Stomach,Small Intestine, Large Intestine,UrinaryBladder,Uterus,Ovary,MammaryGland,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryBland,Eye. -------------------------------------------------------------------------------------------- Animal Number: IR-4656 Sex: Female Group: ( 5) FC-143300 pps Fite: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung Lymph Node (sesenteric) -No visiblelesions. -Chronicprogressivenephropathy,sild Mineralizatioonu,ltifocal,cortical,mild -Nepatocytevicualations,ultifocal,mild -Hemorrhage,oultilocal,mild -Not examined,missing The followingtissueswere found to be withinnormallimits: Brain, Spinal Cord, Bone Narrow,Spleen,Heart,Stomach,Saall-IntestingL,arge Intestine, Urinary Bladder,Aorta,Uterus, Ovary,MammaryGland, Pituitary,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,Pancreas,SalivaryGland, Eye. ------------------------------------------------------------------------------------------ Animal Number: IR-4664 Sex: Female Group: ( 5) FC-143300 ppe Fate: (kek= 53) 1 YearInterimSacrifice MacroscopicObservations: Mammary Gland MicroscopicObservations: Liver Nauary 61&nd -Subcutaneousmass, 3.5 ce dia., left inguinal .area. -Wepitacytevacuolationo,ultifocal,sild -Fibroadencea The followingtissueswere foundto be withinnormal limits: Brain, SpinalCard, Done Narrow,Spleen,Kidney,Heart,Lung, Stomach,Small Intestine, LargeIntestine,UrinaryBladder,Aorta,Uterus,Ovary,Pituitary,Adrenal,Thyroid, ---- - ---------- -------------------- - -- Species: Rat Project Number: 0201CROO12 Summarized STAR Page: 22 186 BusearizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Too year OralToxicity-OncogenicitSytudy in Rats - One Year Interim --- ------- -- ---------------------------------- Table:I - --- ---------- --- Animal Number: IR-4664 Sex: Female Group: ( 5) FC-143300 ppe Fite: (Week= 53) 1 Year InterimSacrifice MicroscopicDbservitions(continued): The followingtissueswere foundto be withinnormallimits (continued): Parathyroid,Trachea,Esophagus,Lymph Node (sesenteriti,Pancreas,SalivaryGland, Eye. -------------------------------------------------------------------------------------------- Animal Number: IR-4666 Sex: Female Group: ( 5) FC-143300 ppe Fite: (Week= 53) 1 Year InterimSacrifice MicroscopicObservations: MicroscopicObservations: Liver -No visiblelesions. -Portalsonanucleacrell infiltrates,ild Portalbileductproliferations,ild The followingtissuessere foundto be withinnormallimits: Brain,SpinalCord, Boni Narrow,Spleen,Kidney,Heart,Lung, Stomach,Small Intestine, LargeIntestine,UrinaryBladder,Aorta,Uterus,Ovary,HisearyBlind,Pituitary,Adrenal, Thyroid,Parathyraid,Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryGland,Eye. --- -- ----------------------------------- --------------------------------------- Animal Number: IR-4669 Sex: Female Group: 1 5) FC-143 300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Liver Lung Hiseary Bland -No visiblelesions. -Hepatacytevacuolation,Bultifocal,mild -Hemorrhage,oultifocal,mild -Not examined,missing The followingtissueswere found to be within normallimits: Brain,SpinalCord, Bone Marro*,Spleen,Kidney,Heart,Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,Pituitary,Adrenal,Thyroid, Parathyraid,Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryBlind,Eye. -- - - --- -- - ------- --------------- --- - ------ ---- ---- ------- ------- Animal Number: IR4671 Sex: Fesile Group: 5) FC-143 300 ppe Fit#: lkeekz 53) 1 Year InterimSacrifice MicroscopicObservations: Nao"ry Blind MicroscopicObservations: Kidney -Subcutaneousmass, 5 co dia., behind left shoulder. -Pelvicmineralizations,ild Calculus,pelvic,mild - ------------- Species: Rat Project Number: 0281CROO12 Summarized STU Page: 23 187 SummarizedSingle TabulatedAnimal Report icantinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3W FC-143: Too YearOral ToxicitY-OncogenicitSytudy in Rats- One Year Interim Table: I --------------------------------- Animal Number: IR-4671 Sex:Fleale Group: ( 5) FC-143300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MicroscopicObservationsicontinued): Liver Lung Mammary Blind Parathyraid -Hipatacytevacuolationo,ultifocal,minimal -Nesirrhages,ultifocals,ild -Fibroadenosa -Not examined,not in plane of section The followingtissueswere foundto be withinnormallimits: Brain,SpinilCord, Done Marrow,Spleen,Heart,Stomach,Beall Intestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, Lymph Node (sesenteric)P,ancreas,SalivaryBlind,Eye. ---------------------------------------- -------------------------------------------- Animal Number: IR-4674 Sex: Female Group: 5) FC-143 300 pps Fate: tweek= 53) 1 Year InterimSacrifice MicroscopicObservations: MicroscopicObservations: Aorta Esophagus Large Intestine Lung Parathyroid -No visiblelesions. -Not examined,missing -Not examined,missing -Not examined,missing -Hemorrhage,oultifocal,mild -Not examined,not in plane of section The followingtissueswere found to be withinnormallimits: Brain,SpinalCard, Done Narrow,Spleen,Liver,Kidney,Heart,Stomach,Small Intestine, UrinaryBladder,Uterus,Ovary, MammaryGland, Pituitary,Adrenal,Thyroid,Trichea, Lymph Node (sesenteric),Pancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------------- Animal Number: IR-4676 Sex: Female Group: 5) FC-143 300 ppe Fate: (Week= 53) 1 Year InterimSicrifice MacroscopicObservations: Mammary Bland MicroscopicObservations: Adrenal Heart Kidney Liver -Titosubcutaneousmasses in both inguinal areas,1.5 and 2 ce dia. Left side milkcyst,rightside cystfilledwithrust coloredfluid. -Sinusoidalectasia,cortex,sild -flyocarditicsh,ronicnonsuppuritivef,ocal, sild -Calculus,pelvic -Wepatacytveicuolitiona,ultifocals,ild - ------ - -------------------------- Species: Rat Project Number: 0281CROO12 SusitarizedSTAR Page: 24 88 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3H FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table: 1 ----------------------------------- ------ - - -- - -------------------- Animal Number: IR-4676 Sex: Female Group: ( 5) FC-143300 ppe Fite: (Neekz 53) 1 YearInterimSacrifice MicroscopicObservations(continued): Lung haseiry61ind -Alveolareacrophageso,ultifocal,sild -6al-actocile 6alactocele One cyst involvedwith chronic inflammatory processwith extensivehemorrhageinto cyst. The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, Done harron,Spleen,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorti,Uterus,Ovary,Pituitary,Thyroid,Parathyraid,Trachea,Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryBland,Eye. ------------------------------------------------------------------------------------------- Animal Number: IR-4687 Sex: Female Group: 5) FC-143 300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: Urinary Bladder Ureter Kidney MicroscopicObservations: Esophagus Kidney Mammary Gland Parathyroid Ureter Urinary Bladder Uterus -Distendedwith urine and containinggreenish sphericalcalculi,0.6 ce dia. -Bilateradlilatatioonf ureters;filledwith cilculineartheend of the bladder. -Bilateralmarked hydronephrosiswith numerous cilculiin the pelvicarea. -No diagnosis,inadequatesection -Hydronephrosisb,ilateral,marked Pyelitis,chronic,moderate -Not examined,missing -Not examined,not in plane of section -Calculus Inflammationc,hronic,diffuse,moderate Dilatation,marked -Epithelialhyperplasias,imple,diffuse,mild Cystitis,chronic,diffuse,moderate -Hydrosetra The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCard, Done Narrow, Spleen,Liver, Heart,Lung, Stomach,Small Intestine, Large Intestine,Aorta,Ovary,Pituitary,Adrenal,7hyraid,Trachea,LymphNode (sesenteric), Pancreas, Salivary61iind,Eye. ---------- --- -------- --- ------------------------------------ -- -------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 25 89 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3" FC-143:Two Year Oral Toxicity-OncOgtnicitSytudy in Rats - One Year Interim Table:I ---------------------------------------------------------------------------------------- Animal Number: IR-4609 Sex: Female Group: 5) FC-143300 ppe Fate: tweekz 53) 1 Year InterimSacrifice MacroscopicObservations: Eye Liver Lymph Node (sesenteric) MicroscopicObservations: Adrenal Eye Liver Lung Lymph Node (sesenteric) Parathyroid Thyroid -Righteye atrophied. -Patetan in color. -Hemorrhagic -Sinuscidalectasia,cortex,mild -Atrophy,unilateral,marked Panaphthalsitisc,hronic,unilateral,marked -Nepatocytevacuolation,oultifocal,mild -Hemorrhage,local areas,sild -Hemorrhage, marked -Not examined,not in plane of section -No diagnosis,inadequatesection The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord, Bone Narrow,Spleen,Kidney,Heart, Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,Mammarygland,Pituitary,Trachea, Esophagus,Pancreas,Salivary Gland. ------------------------------------------------------------ Animal Number: IR-4692 Sex: Female Group: ( 5) FC-143300 pps Fate: (Weeks 53) 1 Year InterimSacrifice MicroscopicObservations: MicroscopicObservations: Lung Lymph Node (sesenteric) -No visiblelesions. -Hemorrhage,local areas, moderate -Not examined,missing The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCord, DoneNarrow,Spleen,Liver,Kidney,Heart,Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,Mammarygland,Pituitary,Adrenal, Thyroid, Parathyraid,Trachea,Esophagus,Pancreas,SalivaryBland, Eye. ------------------------------------------------------------------------------------------ Animal Number: IR-4699 Sex: Female Group: 5) FC-143 300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Large Intestine Liver -No visiblelesions. -Sinusoidalectasia,cortex,mild -Nesitodiasis -Nepatacytevacualationo,ultifocal,sild Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 26 190 SummarizedSingle TabulatedAnimalReport (continued) IndividualMacroscopicand Microscopicobservations RikerLaboratoriesI,nc. SH FC-143: Two Year Oral Toxicity-OncoolniciSttyudy in Rats - One Year Interim Table: I -- ----------------------------------------------------- - -- ----------------- - - Animal Number: IR-46q9 Sex: Female Group: ( 5) FC-143300 ppe Fate: (Week= 53) 1 Year InterimSacrifice MicroscopicObservations(continued): Lung -Hemorrhage, local areas, moderate The followingtissues were found to be within normal limits: Brain, Spinil Cord, Bone Narrow, Spleen, Kidney, Heart, Stomach, Small Intestine, Urinary Bladder,Aorta, Uterus, Ovary, Mammary Blind, Pituitary,Thyroid, Parathyraid,Trachea, Esophagus, Lymph Node (sesenteric),Pancreas, Salivary Gland, Eye. ------------------------------------------------------------------------------------------------ Animal Number: IR-4704 Sex: Female Group: Fate: (Week= 53) 1 Year InterimSacrifice 5) FC-143 300 ppe Macroscopic Observations: Microscopic Observations: Adrenal Liver Lung Thyroid -No visiblelesions. -Corticaldegeneration,focal, unilateral, mild -Portalsononuclearcell infiltrate,mild Hepatocytevicuolation,sultifocal,mild -Vascularmineralization,sild Hemorrhage,oultifocal,sild -Not examined,not in plant of section The followingtissues were found to be within normal limits: Brain, Spinal Cord, Bone Narrow, Spleen, Kidney, Heart, Stomach, Small Intestine, Large Intestine,Uriniry Bladder, Aorta,Uterus, Ovary, Mammary Gland, Pituitary,Parathyroid, Trachea, Esophagus, Lymph Node (sesenteric),Pancreas, Salivary 61and, Eye. ---------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 27 191 SummarizedSingle Tabulated Animal Report IndividualMacroscopicand Microscopic()bservatiens RikerLaboratoriesI,nc. 3M FC-143:Tma Year Oral Toxicity-Oncogeni--iSttyudy in Rats ------------------------------------------------------------------------------------------------- Animal Number: IR-3518 Sex: male 6roup: 1) CONTROL 0 ppe Fate: (Weelz106)TerminalSacrifice Table: RacroscooicObservations: Skin MicroscopicObservations: Adrenal @.idney L@ver Lung Pirathvrcid Pituil%.-ary ski,Th,,roid -Raisedinflateedles@onan right rear footpid. -Corticalvacualatio,o,u.l,tifocil,gild Med-,@llacreyll hyperplasia,oultifai.,.miill,d -Myocarditis,chronicnonsuppurall-ive, local areas.,moderate -Chronicprogressivenephropatlkisyi,nita', Pelvicmineralizatienm,iniial -Portalsonanuclearcell infiltrate,aip@isal Portalbile duct prolifer;t-*@car@il,d -Vascularmineral.i.-itimoinn,imal Pnet;ao,-;iinit,erstitialc,hronic,oul@tifocal, ail&d Perivascularsonanucleariniiltrate,moderate -Not exagined,siss;.ng -A6enota -Podaderiia'64,t4u,lsc,erative, hindleg, marked -ke examirii!mci,ssing The fcllcwi@,+.issueewe-e 4ound to be Nithinnormallimits: Brii@,,Sr'ri! Cord, Be-e Parroog, Spleen, Stomach, Small Intestine, Large Intestine, U,-@4,@.ary Aorti, Testis/Epididyt,.s, Prostate, Trachea, Esophagus, l6 ytp.@ Node (sesenLleric), Pancreas, Salivary 61and, Eye. -------------------------------------------------------------------------------------------------- Anima! Nuster: 1R-*3519 Ser@: Male F .4iLe:(Weei.=106) Teri4inalSacrifice 6ro,.,;: 1) CDNTRm.1-0 ppi ?.acroscopic Observations: -No visible lesions. Picrosc-.picObservations: Adrenal -Sinusoidal ectasia, cortex oult;44ocal,sild Cortical vacuolation, oul,ti4ocal,sild Esophagus Heart --mNyo',examined, missing ocarditis, chronic nonsuppurative, oult4lfocal,mild Kidney -Chronic progressive nephropithy, mild Liver -Portal sonanuclear ce'41infiltrate, a4Ald Portal bile duct proliferation,sild Nepatacyte alteration, vacuolated, oulti4ocall, sild --------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 29 192 SummarizedSingle TabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3H FC-143:Two Year OralToxicity-OncogenicitSytudy in Rits Table: 2 --------------------------------------------------------------------------------------------- Animil Number: IR-3519 Sex: Male Group: ( 1) CONTROL 0 ppe Fate: (Weeks106)TerminalSacrifice Micros:opicObservations(continued): Lung -Vascularmineralizations,ild Perivascularsononuclearinfiltrate,moderate Pneumon,.i,nterstitialc,hronic,elltifocil, moderate The fol'ow@Antgissueswere found to be within normal limits: Brain,SpinalCord, Pone Marrow, Spleen,Stomach,Seal] Intestine.L,arge Intest@ne, UrinaryFladder,Airta,Testis,'Ep44didysPirso,state,Pituitary,Thyroid,ParaLtyroid,Trachea, Lymph Node (sesenteric),Pancreas, Sil4avaryGland, Eye. -------------------------------------------------------------------------------------------- Animal Number: Sex: Male Group: 1) CONTROL 0 pps Fate: (Week= 92) Sicriiice4iln extresis P.a:rosco@l.iO@b.servations: Skin Liver Spleen Micros:o;:cObservations: Ad-e,-,a'. Rea-lKi,.Iney '6iver Lung Parithyroid Skin Spleer, Stomach -Both hind 4cotpadsulcerated. -Pal&e -Enlarged -Corticalva@.uolationl,ocal areas,sild Medullsarcvell hyperplasia,oultifocal,mild -Myocardialfibrosis,oultifo.@alaa@,ild -Chronic progressivenephropathy,noderal,-e -Hepitocytevacualaticn,centrilobular, moderate -Yascularmineralizationm,ild Pneumonia,interstitialc,hronic,localareas, mild Edema,local areas,aild Fibrosis,pleural,sild Thrombus -Not eramined,missing -Podadersititisu,lcerative,hindleg,marked -Hesatopoiesis,extramedullary,increased, -moderate -Edeaa, subsu,.osal,marked The followingtissueswere foundto be within normallimits: Brain, SpinalCard,Bone Marrow,Small Intestine,Large Intestine,UrinaryBladder,Aorta, Testis/EpididyaisP,rostate,Pituitary,Thyroid,Trachea,Esophagus,LymphNode (sesenteric), Pancreas, Salivary 61&and,Eye. -------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Sumarized STAR Page: 29 193 SummarizedSingle TabulatedAn4lealReport (Continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. SH FC-1470:Two Year Oral Toxicity-OncogenicitSytudy in Rits Table: 2 -------------------------------------------------------------------------------------------- Animil Number: IR-7,SA'3 Sex: Male Group: 1) CONTROL 0 ppe Fate: (Week= 95) Sacrificedin extreois MicroscopicO@servations: SoftTissues (thorax) Stolic", P,44-,rosccpOibcservations: Adrenal Heart Kidney Liver lung Prostate Skin -Miss,10 x 9 x 4 co in leftfixillianvolving musclleand rib, ex-te,-.,.iInitnog leftthoraciccavity,collapsingleftlung Mass soft and fatty. -Willedematouswith possibleulcerationin cirdia. -Corticalvacuolationo,ultifocals,ild Sinuscidalectisia,cortex,diffuse,mild -Myocardiaflibrosis,oultifocals,ild -Chronicprogressivenephropathy,mild -Portalsononucleacrellinfiltrate,aild Portalbileductproliferationo,ild Nepatocytealterition,vacuolated,mild -Yesculirmineralizitionw,ild Hemorrhage,fecil,sild Alveolareacrophiges,aild -Prostatitisi,cute,suppurative,marked -Fibrosircomi,thorax Well differentiatedh,ighlycellularwith moderateCollagenformation, -Ulcer, marked The iollow-.ntgissueswere4ound to be withinnoriiilimits:. Bri44n,Sp@4,,tCiolrld, Bone Hi@row, Spleen, Small Intestine,Large Intes'6ineU,rinary Blalder, Aorti,Testis/Epididyt4lPsi,tuitary,Thyroid,Parithyraid,Trachea,EsephigLs, Lymph Node (sesenteric)P,ancreas,SalivaryBlind,Eye. --------------------------------------------------------------------------------------------- Animal Number: IR-'.T524 Sex: Mile Sroup: t 1) CONTROL 0 ppe Fite: (Week=106)TerminalSicrifice MicroscopicObservations: Pituitary -Smallred lesion. P,icroscapiOcbservations: Adrenal Kidney -Medullarycell hyperplasiao,ultifoca'l.gild -Chronicprogressivenephropithy,moderate Pelvicminerilizationm,ild Large Intestine Liver -NesatDdiasis,colon -Nepatacytealteration,vacualited,moderate Portalsonanucleicrellinfiltratem,ild Portalbileductproliferations,ild --------------------- ------------------------------------------------ Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 30 194 Sumarized SingleTabulatedAnimalReporLt (conta inued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143;Too Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 ---------------------------------------------------------------------------------------------- Animal Number: IF-1524 Sex: Male Group: ( 1) CONTROL 0 ppe Fite: (Week= 106) Tera@AnalSacr;f@sce MicroscopicObservations(continued): Lu.-@g Lymph Node (sesenteric) PPiatrUa'Lhyroid itary Thyroid -Vascularsineral@Izatiors,i,ld -Not examined,missing -Not examined,not in plane of section -Adenama -Folliculahryperplasiic,ystic,unilateral, moderate Large cysticlesionoccupyingsuch of are thyroidlobe. The followingtissueswerefound to be withinnormallimits: Brain,SpinalCord, Bone Narrow,Spleen,Hear",Stomach,Saa!l Intestine,UrinaryBladder, Aorta, Test4is/EpididyeasP,rostate,Trac@.ei,Esophagus,Pancreas,SalivaryGland, Eye. ------------------------------------------------------------------------------------------------- Ar,ima,Number: IR-T--)@ Sex: Male Ercup: 1 1) CONTROL 0 pps Fate: (4eek=106) TerminalSacrifice Macrosci3piOcbseryitions: Bone Liver MicrosccpicObserval,ions: Adrenal Bone Heart Kidney Liver Lung Parithyroid Spleen Testis/Epididysis -Jointsof rightforelimband righthindliab swollen. -Raisedpalecircularlesion,2 ce dia.,in sed@gallobe. -Corticalvicualation,localareas,moderate -Arthritiss,ynovitisj;oints,foreleg, hindleg, marked -Myocarditis,chronicnonsuppurative, local areas,mild -Chronicprogressivenephropathy,moderate -Portalmonanucleacrell infiltr&tes,ild Portalb;.Ieduct prol;4erations,iId Hepatacellularcarcinoma Large,poorlydifferentiateda,niplastic, infiltrative.Adenoidareas.Multipletumor eaboliin lung. -Vascularsineralizatiaps,i,ld Metastaticneoplasm -Not examined,not in plane of section -Meeasiderosiss,ild -Tubuleatrophy,aspersitagenesiss,ild The followingtissueswere foundto be withinnormal limits: Brain,Spinal Cord, Bone Narrow,Stomach,Small Intestine,Large Intestine,UrinaryBladder, --------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CP0012 Summarized STAR Page; 31 19 5 SummarizedSingleTabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. IOM FC-143:Two Year OralToxicity-oncogenicitSytudy in Rits Table: -------------------------------------------------------------------------------------------- Animal Number: IR-35.15 Sex: Mile 6roup: ( 14)CONTROL 0 ppe Fate: ikeekz106)Tera-"naSlacrifice M:IcrostapiOcbservationsicc)ntinued): The followingtissueswere foundto be withinnormallimits(continued): Aorti,Prostate,Pituitary,Thyroid,Trachea,Esophagus,LysphNode (sesenteric)P,ancreas, SalivarySiand, Eye. --------------------------------------------------------------------------------------------- Aniqal Number: IR-l.';26 Sex: Male Group: 1 1) CONTROL 0 ppa Fa@,e:(keek=1061 Teraina!Sacrifice Ma:roscopicObservations: MicroscopicObservations: k,'idney Liver Lung -No visibllleesions. -Chronic progressivenephropathy,m4Ald -Portalsononucleacrell infiltratem,ild Portalbileductproliferationi,i'd Cystaiddegeneration,focal,mild Nepitocytielteriticiv,acuolatedo,il.' -Vascularmi,-)erali,-ats;i*lodn, The followingtissueswere found to be withifinormal&limits: Brain,Spi.-.i'".o,-dB,one ?.irrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, Uri,-,aBrlyadder,Aor'6i,Testis!Epidi4uymiPsr,ostate,Pituitary,Adrenal,Thyroid,Pirathyraid, Trachea, EsDp.-iigusL,yiipiN@-@4,eliesenteric),Pancreas,Salivary gland, Eye. --------------------------------------------------------------------------------------------- An4a.-.aNlumber: Sex: Male Fate: (Week=1406)Teraina!Sacrifice Group: 1 1) CONTROL 0 ppo MacrcscepicObservations: Kidney P.ir.rescepiOcbservations: Adrenal Kidney Liver Lung Pituitary -Hydronephrosis -Corticilvacualationf,ocal,sild -Chroni,.progressivenephropal,hy,moderate Hydranophrosis,unilateral,moderate -Portalmanonuclearcell infiltratem,ild Portalbileductproliferations,ild Repa,6ocytveicualitiono,ultilocal,sild -Yascularmineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, sild -Hyperplasiaf,ocal,pars distalis,mild The followingtissueswere found to be withinnorgillim4ats: Brain,SpinilCord, Done HirratsS,pleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Thyroid,Parithyroid,Trachel,Esophagus, -------------------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 Susaarized STAR Page: 32 19 6 SummarizedSingle TabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3M FE-143:Two Year Oral Toxicity-OneogenicitSytudy in Rits Table: 2 --------------------------------------------------------------------------------------------- Animal Nuaber: IR-3528 Sex: male Group: ( 1) CONTROL 0 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations(continued): The followingtissueswere foundto be withinnormillimits (continued): Lymph Node imesenteric),Pancreas,SalivaryGland, Eye. --------------------------------------------------------------------------------------------- Animil Number: IR-3529 Sex: Mile Group: 1) CONTROL 0 ppe Fate: (Week= 96) Sacrificedin extresis MacroscopicObservations: Skip, Liver MicroscopicObservations: Adrenal Kidney Liver Lung F.iratl.-.yroid Prosl@ill-e SalivaryGland skin Urinary?ladder -Areasof dereat4Atiwsth hiir loss,some !icabbed;back, s@lde.a,bdomen. -Raisedpale mass, 1.2ce dia. in left lateral lobe. -Corticalvacualationo,ultifocilo.',lld -Chronicprogressivenephropathy,itild -Part&]sononucleacrellinfiltrates,ild Nepatatellularcarcinoma Trabecularpattern,fairlywell differentiated. -Vascularsineralizationo,'ld Edema, sub;le-jralm,oderate -Not examined,not in plane of section -Not examined,missing -Not examined,missing -Ulcer, back, abdomen.,marked -Epitheliahlyperplasias,imple,di4fuse,s'lld The fcllooiirtgissueswere foundto be withinnormallimits: Bra@An,Spinal Cord, Bone Narrow, Spleen,Heart, Stomach,Small ln,6es+.inLea,rge Intestine, Aorta,Testis/EpididysisP,ituitary,Thyroid,Trachea,Esophagus,Lymph Node (Resenter4Ac), Pancreas, Eye. -------------------------------------------------------------------------------------------- Animal Number: IR-351@O Six: Male Group: 1) CONTROL 0 pps Fate: (Week=106)TerminalSacrifice MacroscopicObservations: -No visiblelesions. MicroscopicObservations: Heart -Myocarditis,chronicnonsuppurativef,ocal, minimal Kidney Liver -Chronicprogressivenephropithy,mild -Portalsononucleacrellinfiltrates,ild Portalbileductproliferationm,ild Cystaid degeneration,focal,moderate Hepatocytealteration,vacualated,mild ------- -- ----------------- ------------- --- ------------------------------------------ Species: Rat Project Number: OI&BICROO12 Summarized STAR Page: 33 19 7 SulearizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3m Flu-143:Two Year Oral Taxici"Y-OncogenicitSytudy in Rats Table: 2 -------------------------------------------------------------------------------------------- Animal Number: IR-'.FV,30 Sex: male Group: ( 1) CONTROL0 ppe Fate: (4eekz1061 Teraina!Sacrifice MicroscopicObservations(continued): Lung Sp,leen -Vascularmineralizationw,ild Peribror,chiallyapheidhyperp',Iasimai,ld -Hesosiderosisw,ild The followingtissueswere foundto be withinnormalliaits: Braii, Spinallord,P:ne Parrcv,Statich,Small Intest;,neL,arge Intestine,Urinarylladler, A.-@l,iT,estis!E;4didymisP.r,ostate,Pituitary,Adrenal,Thyroid,Parathyraid,Trachea, Esop@ia;@s,l,yephNode isesenter4lc)P,ancreas,Salivary Gland..Eye. ------------------------------------------------------------------------------------------------- Ana4b.iiNumber: IF,4-.4,@lC, Sex: Male Group: Fate: (Week=106)Tersina'Saicrif4lie 1) CONTROL 0 ppe MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung -No visiblelesions. -Chronicprogressivenephropathy,sild -Hepatacytevacuolation,sultifocal,sild Portalmanonuclearcell infiltrate,minimal -Vascularaineralizationm,ild Pneumonia,interstitialc,hronic,localareas, moderate The followingtissueswere foundto be withinnormal limits: Brain,Spina',Cord, Done Marrow',Spleen,Heart, Stomach,Small Intestine,Large Intestine, Urir,arByladder,Aorta,Testis/EpididysisP,rostate,Pituitary,Adrenal,Thyroid,Paral.hyraid, Trachea,Esophagus,Lymph Made (sesenteric),Pancreas,Saliva,ySland,Eye. --------------------------------------------------------------------------------------------- Animal Number: IR-3532 Sex: Male Group: 1) CONTROL 0 ppe Fa4Le:(Week=106) TerminalSacrifice Macroscopic Observat;@ons: Pituitary Kidney -RaiseA61 red miss, 0.4 ce dii. -Fluidfilledcyst,I co dia.,in rightkidney MicroscopicObservations: Eye Heart Kidney -Retinalatrophy,focal,mile -Myocardialfibrosis,focal,mild -Chronicprogressivenephropithy,moderate Cyst, cortical,marked Liver -Portalmonanucleacrell infiltrateo,ild Portalbile ductproliferations,ild Lung -Vascularmineralizations,ild Pneumonia,interstitialc,hronic,oultifocal, aild Hemorrhage,local areas,sild Perivascularsonanuclearinfiltrate,sild ------------------------------------------------------------------------------------------ Species: Rat Project Number: 0281CROO12 SuiisLrizedSTAR Page: 34 19 8 Susairi.-eSdingleTabulatedAnizilReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLiboratoritsI,nc. 34 FC-143:Two YearOral Toxicity-OncogenicitSytudy in Rits Table:2 ------------------------------------------------------------------------------------------ AniailNumber: IR-75'@2 St@-:Male Group: ( 1) CONTROL0 ppe Fate:(Week=106)TerminalSicrifice F,4,crosco;Oib,s@ervations(continued): Lyapt,NDde (sesenterici Pituitary Sp',eer. -@esorrhaoe,mild -Adenoma -Heicsiderosis,a@Lld The iollow@lptgi5sueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Stomach,SmallIntestine,LargeIntestine,UriniryBladder, Aorti,Testis/Epid@idysPirso,state,Adrenal,Thyroid,PirathyraidT,richea,Esophagus,Pancreas, S,;',,varGyland. ---------------------------------------------------------------------------------------- Animal Number: IR-'4cj'.3 Sex: Mile Group: 1) CONTROL 0 pps Fite: (Week=106)TerminalSicrifice MicroscopicObservations: Sple;n MicroscopicObservations: Eye Heart Kidney Liver Lung Pros'6ite Szleer, -Pilecirculardepressedarea,0.4 co dia. -No diagnosis,inadequatesection -Myocarditis,chronicnonsuppura'6ive, oul'@ifocatli,!d -Chronicprogressivenephropathyw,ild -Part&]moronucleicrellinfiltrate2,i!d Nepitacytveicuolitiono,ultifocalt,ild -Vascularminerilizatio@a-iil,d Pneumonia,interstitialc,hronic.s,ul4'Lifocili, sild Perivisculasrononucleairnfiltrates,ild -Prostatitisa,cute,suppurativee,i'Ad -Nesesiderasist,ild Fibrosis,localareas,moderate The followingti.9suewserefoundto be withinnormallimits: Briir.S.p,inalCard,BoneNarrow,Stomach,SmallInt;stineL,argeIntestine,UriniryBladder, Aorta,Tes'@is,EpididysPiist,uitary,Adrenal,Thyroid,ParathyroidT,rachea,Esophigus, LymphMode (sesenteric)P,ancreas,SalivaryGland. ---------------------------------------------------------------------------------------- Animal Number:IR-3534 Sex: Mile Group: ( 1) CONTROL0 ppe Fate:(Weeks105)Sacrificedin extresis Racroscopic Observations: Thymus -Enlarged Pancreas -Massivebeigecoloredmiss,7.5x 3 ce in area of pancreascompletely surroundingspleenand adheringto posterior areasof rightandleftlateral ------------------------------------------------------------------------------------- Species:Rat Project Number: 0261CROO12 Summarized STAR Page: 3ri 19 9 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand Microscopicobservations PikerLaboratories,Inc. 3m FC-1474:Two Year oral Toxicity-OncogenicitSytudy in Rats Table: 2 -------------------------------------------------------------------------------------------- Animal Number: IR-35.114 Sex: Male Group: 1) COWTROL 0 ppe Fite: (keek=105) Sacr-&ficeidn extresis Pacres-.opiOcbservations(continued): Pancreas (cortinued) @.'i,wl-,ey Tes'6,s,'Ep4ld'adyr.;,s P.;Yer P.@,:rcscapicObservi'6ioris: Ad,-enal Kidr!ey Liver Lung Lyo;h Node (sesenteric) Pancreas Pirathyraid Pituitary Small Intestine Spleen Stomach Testis!Epididysis Thymus Thyroid Urinary Bladder -liverlobes -Fileand piited. -Right testis small. -Pale with yellowish circular lesion 0.',ce diameter in right interior labe -Cortical vacualation, diffuse, saderite Medullary cell hyperplas@ii,loca! areas, moderate -Chronic progressive nephropa4@-hy,moderate Malignin'6lyaphoma, histiocytic -Hepatocyte vacuolation, diffuse, marked -Hemorrhage, diffuse, marked malignant lymphoma, histiocyt4kc -Hemorrhage, mild Malignant lymphona, histiocytic -Malignant lyaphoma, histiocytic -Not examined, missing -Adencoa -Malignant lymphoma, histiocytic -Malignant lyaphomal histiocytic 4&lignant lymphoma, histiocytic -Tubule itraphy, ispereatagenesis,unilateral, marked -Malignant lymphosa, histiocytic Multiple sections of tumor from thymic and sediastinal areas. -Not examined, missing -Rilignant lyaphDIi, hiStiDCy4L41'@ The following tissues were found to be within normal limits: Brain, Spinal Cord, Bone Narrow, Heart, Trachea, Esophagus.,Salivary Blind, Eye, Large Intestine, Aarti, Prostate. ----------------------------------------------------------------------------------------------- Species: Rat Project Number: 0261CROO12 Summarized STAR Page: 36 200 Sumir;zed SingleTabulatedAnimalReport (continued) lidivi;uilMicroscopicand MicroscopicObservations RikerLaboratc),iesI,nc. 3H FC-143:Two Year Oril Toxicity-OncogenicitSytudy in Rats Table: ---------------------------------------------------------------------------------------------- Anisil Number: IR-1@536 sex: mile Group: 1) CONTROL 0 ppg Fa'Le:lweek=106) TerminalBicrifice Hicros:opicObservations: MicroscopicObservations: Adrenal K drey Large Intestine L@ver Lung Skin -Raisedlesion,1.5 ce dia.,appearsto be abscess. -Corticalvacl:olati'o.fnocal.mild Sinuscidilectisii,Corte%,foci'&,moderate -Chronicprogressivenephrepathy,minimal -Resatodiasis,colon -Portalbileductproliferationo,ultifocal, aild Portilm,onanuclearcell&infiltrate,wild NepatDCyteVaCuOlitiOn,$UltifOCal,minimal -Vascularminerilizations,44ld Per4avascul.iaornonuclearinfiltrate,ei',d -Keratoicanthoma Raised lesion fro@ back. The followingtissueswere foundto be withinnormallimits: B@,i;tnS,pnal Card, Bone Mirrow,Spleen,Heart,Stomach,Small Intestine,Aorta, Testis.!Epid4idysPirso,state,Pituitary,Thyroid,PiirathyraidT,rachea,Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryBlind,Eye, Ur4aniryBladder. ---------------------------------------------------------------------------------------------- Anisil Number: IR-7.537 Six: Male Group: 1) CONTROL 0 pps Fate: (Week= 73) Found Dead MicroscopicObservations: Liver Lymph Node (abdominal) Abdomen (internal) Pituitary -Very pale -Renal lymph nodes enlarged. -Multilobularf,leshymiss,4 x 3.5 x 3.5 attachedto amentus,left inguinal area. -Hemorrhagicmiss, 0.7 ca dii. MicroscopicObservations: Eye Heart Liver Lung Lymph Node (mesenteric) Pancreas -Not examined,missing -Malignantlyaphosa,histiocytic -Nepatacytevacuolition,diffuse,marked Malignantlymphosi,histiocytic -Malignantlyiphomi,histidc)tic Hemorrhage,local areas, moderate -Not examined,missing -Not examined,missing Parithyraid -Not examined,missing -------------------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 Summarized STAR Page: 37 20 1 SummarizedSingle TabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Two Year Ural Toxicity-oncogenicitSytudy in Rats Table: 2 --------------------------------------------------------------------------------------------- Anisil Number:IR-3F,7 Sex: Male Fate: (Week= 73) Found Dead Group: 1) CONTROL 0 pps MicroscopicObservations(continued): Pituitary Skin Splee@-. Thyroid -Adenoma -Malignantlymphomi,histiocytic Massfrot inguinalarea *as salignan4, lyaphoma. There *is extensivenerrt)s@isn tumor. -Hemos;lderos@as,n;,Id -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Mirrow,Kidney,Stomach,Stall Intestine,Large Intestine, Urinary Pladder,Aorti, Test;is/EpididysiPsr,ostate,Ad,enil,Trachea,Esophagus,SalivaryBlanul. ---------------------------------------------------------------------------------------------- O.nisa;Number: IR-')rig Sex: Male Group: 1) CONTROL 0 ppe Fate: (Weei=106) TerminalSacrifice MicroscopicObservitiors: Pituitary Liver Spleen MicroscopicObservations: Adrenal Kidney Liver Lung Lymph Node (sesenteric) Parathyraid Prostate Spleen Urinary Bladder -Small hemorrhagicarea,O.Alto dia. -Multiplepilefoci,all lobes. -Enlarged -Corticalvacuolationf,ocil,eild -Chronicprogressivenephropathy,sild -Malignantlymphoma,histiocy'Lic -Vascularmineralizationm,ild Alveolar macrophages, a4kld Malignantlymphosa,histiocytic Perivasculamri)nonucleairnfiltrate,sild -Hemorrhage, sin-'Asal -Not examined,not in plane of section -Pros'6atitisa,cute,suppurative,marked -malignantlylphola,his,6iocytic -Epithelialhyperplasia,simple,dif4use.m,ild The followingtissueswere foundto be withinnoreal.lisits: Brain,SpinalCard, Done Narrow,Heart,Stomach,Small Intestine,Large Intestine,Aorta, Testis/EpididysisP,ituitary,Thyroid,Trachea,Esophagus,Pancreas,SalivaryGland, Eye. ----------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 38 202 SummarizedSingle TabulatedAnimal Report (continued) ln4ividuliMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-147@:Two Year Oral Toxicilly-OntogeniciSttYudy in Rits Table: --------------------------------------------------------------------------------------------- Anima! Number: IR-3539 Sex: Mile Group: 1) CONTROL 0 pPs Fite: (Week=106)TerminalSacrifice Microsco,,iO:bservations: MicroscopicObceryitions: Kidney Large Intestine Liver Lung Parathyroi,ul Pituitary Spleen Thyroid -No visiblelesions. -Chronicprogressivenephropithy,oild -Nesatodiasis,colon -Partilscionucleacrellinfilstri'aLiel,d Hepatocytevacuolition,oultifocal,s,i!d -Vascularsinerilizations,ild Pneusor.iii,n-Ilers'6-icthirioln,ic,oultifocal, mild Periviscul.siornonuclearinfiltrate,mild -Not examined,not in plane of section -Cyst,pirsdistilis -Hemosiderosis,mild -Ultisabranchiaclyst The followingtissueswere foundto be withinnormal limits: Brain,Spinil Cord,ioneMarrow,Heart,Stomach,SmallIntestine,UrinaryBladder,Aartl., Test@ls,'Ep@tdidysPirso,state,Adrenal, Trachea, Esophagus,Lymph Made (sesenteric),Pancreas, Salivary SlanuO,Eye. ----------------------------------------------------------------------------------------------- Animal Number: IR-7@54(i Sex: Male Fite: (Week= 64) Found Dead Group: 1) CONTROL 0 pps Macroscopic Observations: MicroscopicObservations: Bone Marroo Liver Lung Prostil@e Spinal Card Thyroid Urinary Bladder -No visiblelesions. -Not examined,missing -Portalsonanuclearcellinfiltratea,;ld Part&]bile duct proliferationm,ild -Vascularmineralizations,ild Alveolar macrophages,mi'Ad -Not eximined,missing -Not exan-'anedm,issing -UltilDbranchiiclyst -Not exiained,missing The followingtissueswere foundto be withinnormal limits: Brain,Spleen,Kidney,Heart,Stomach,Small Intestine,LargeIntestine,Aorti, Testis/EpididyBisP,ituitary,Adrenal,Parithyraid,Trachei,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryGland, Eye. --------------------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 Summarized STAR Page: 39 203 SummarizedSingleTabulatedAnisilReport (continued) IndividualMicroscopicand MicroscopicObSefvatio-is RikerLaboratoriesI,nc. 3H FC-143:Two Year Oril Toxicity-oncogenicitSytudy in Rats Table: 2 ------------------------------------------------------------------------------------------- An-'salNumber: IR-3l.;41 Sex: Male Group: Fate: (Week=106)TerminalSacrifice 1) CONTROL 0 ppi MacroscopicObservations: Skin MicroscopicObservations: Adrenal Kidney Liver Lung Frostate Sk n Testis/Epididyeis Urinary Bladder -Raisedles4sonan left rear 4oatpad. -Corticalviicuolatiofno,cal,mild Sinusaidalectisia,carte.,min-"aal -Chronicprogressivenephropatny,tiniial, -Portilsonanuclearcell iniil46-ratsei,ld Portalbile duct proliferations,ilad -Vascularmineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, mild Hemorrhage,diffuse,aarked Perivisculamranonuclearinfiltrate,aild -Not examined,missing -Podadernatitisu,lcerative,hindleg,marked -Not examined,missing -Not examined,missing T,)efcillow'it,i-s,sgueswere found to be withi'nnormallimits: Brain,SpinalCard, Bone Narrow,Spleen,Heart,Stomach,Small Intestine.L,arge Intestine, Aorta, Pituitary,Thyroid, Parathyraid,Trachei, Esophagus,Lyaph Mode lsesenteric),Panc@eas, Sil',va,iyiand,Eye. -------------------------------------------------------------------------------------------- An4isal,Number: IP,-3541 Sex: Male Group: Fate: (Week=106) Ter;inalSacrifice 1) CONTROL 0 ppe MacroscopicObservations: Testis/Epididysis MicroscopicObservations: Kidney Liver Lung Lymph Node (sesenteric) Pancreas Testis/Epididysis Thyroid -Both testessmall. -Chronicprogressivenephropithy,moderate -Hepatocytevacuolation,oultifocalim,ild -Yascula?m-ineralization,minimal -Hencrr,@age,minimal -Hyperplasiai,sletcell,moderate -Tubuleatrophy,aspermitogenesisb,ilateral, marked Polyarteritism,ild -Not examined,missing The followingtissuesmere found to be within normallimits: Brain,SpinilCard,Bone Farroo,Spleer,H,eart,Stomach,Sail',lnl,estintL,arge Intestine, UrinaryBladder,Aorta,Prostate,Pituitary,Adrenal,Parathyroid,Trachea,SalivaryGland,Eye, Esophagus. ---------------------------------------------------------------------------------------- Species: Rat Project Number: 0201CROO12 Summarized STAR Page: 40 204 SummarizedSingle TabulatedAnimal Report icontinued) IndividualMicroscopicand microscopicDbservitions RikerLiboratoriesI,nc. 3M FC-143: Two Year Oral Toxicity-OncogenicityStudy in Rats Table:2 ----------------------------------------------------------------------------------------- Anisil Nualwer:IF-3544 Sex: Male Fite: (Week= 106) TerminalSacrifice Group: 1) CONTROL 0 pps Macroscopic Observations: Pituitary Kidney Testis/Epididymi5 MicroscopicObseryaticis: Adrenal 0,.'idiev Liver Lu!lg Pancreas Parat@@yroi.d Pituitary Spleen Testis/Epididys4,s -NeGarrhagiclesion,0.7 ct dii. -Bcth enlarged,pal,eand pitted. -Lefttestissmall. -Cortica'v@acuola'Liono,ultifoca!,moderate Sinusoidalectasia,cortex,moderate -Chronicprogressivenephropathy,marked -Hepatacytveacualationo,ultifocals,ild -Vasculara4Aneralizat@acan',Ald Alveolarmacrophages,sild -Ar.inaartrophy,sild Polyarteritism,oderate -Not examianedn,ot in planeof section -Adenoma -Hemosiderosis,@44ld -Tubuleatrophy,isperiatagenesiusn,ilateral, marked Polyarteritism,arked The followingtissueswere foundto be withinnormallimits: Brain,Spin&!Cord,BoneMirrow,Stomach,SaillIntestine,LargeIntestine,UrinaryBladder, Aorta,Prostate,Thy-oid,Trachea,Esophagus,LymphNcide(iiesentericS)a,livaryGland,Eye, Heart. ----------------------------------------------------------------------------------------------- AnimilNL.,eberI:F-3545 Sex: Mile Group: 1 1) CDNTRDL0 ppi Fite: (Week=104)FoundDead MacroscopicObservations: Skin Liver MicroscopicObservations: Adrenal Eye Heart Kidney Litng Pancreas Pituitary -- -------------------------------------- -Circularlesions,2.5 ca dia. on bothhind footpids. -Slightlpyale -Sinusaidaelctasia,cortex,moderate Corticalvacuolitiono,ultifocalm,oderate -Not examined,missing -Myocardiaflibrosisl,ocalareas,sild -Chronicprogressivenephropathy,sild -Vascularmineralizationa,@Ald Alveolarmicrop,@agesm,ild -Acinaratrophy,moderate -Adenosa -- --------------------------------------- Species:Rit Project Number: 0281CROO12 Summarized STAR Page: 41 205 SummarizedSingle TabulatedAnimalReport (continued) IndividualMacroscopic and "4,crosco;iOcbservations Riker Laboratories,Inc. '@'M FC-143:Two veirOral Toxicity-oncogenicitSytudy in Rats ---------------------------------------------------------------------------------------------- Animal Nimber: IR-3545 Sex: male Fite: (Week--104) Found Dead 6roup: ( 1) CONTROL0 ppi Microscop@IOcbservations(continued): Sk4r. Sp'ieen -Podadereat-',",;uLlsc,erat@lve, bilateral,m,arked -Hemattpciesis, a; I,; &46 The +cl1,cw-ln; t@,ssues were ;cu.-, a be v;I'@ n.-rci ,t s Brain, Sp:nal Cord.,Bone .4arroi(L,ive-, S4.,cta:hE,-@i:" li-;e lnl,es@-;ne, I!ri -ari iii4@cer, Pr::ta'e,Th-f-o;dP,arit@,yro;dT,racl-eiE,s.@;',i;,s, Lyo;@---------------------------------------------------------------------------------------------- c.ey:Olile Brou;: I; CONTRr.110-ppt 'Wzz' e-@t-El@S -Mass,0.4 cc aig. -Pale e iLLIr: -0"@4.;otendrog&icabie.r,,;;r -,ec;',ism of ',,ar;e, u.-ifors -el'Is @A.- ccrle@. prz;ressive nep.@-t.r@-pal@hy, i-,utem,ild a.-nz.-,u:lceealr, irf;lltral%r-.e;,,,4u He;a'6@,:yi.v-aetuol.atio.,4p,er@lp,,@rtalm,o,dera*,e -Vas.,ul&aar4&,@ierillizit@aliolnd, -Aderosa -Edema, subiucosi!,moderate i!-e tiss-,iweesre foundto be wi"4,in,area!limits: E;@ar-.ri@l'c-dB,one P@irrow.S,p!een, Heart, Small In,@6ee.ineL,arge ln'6esti-,iUer,ir!aryBladder, A:r'Li,'iest'is/Epidi46ymPirso,sta'@-eT,hyroid,Parathyraid,Trachea,Esophagus, l6yr.;l NDAvE (mesenteric),Pi,-icreasS,alivarySlard. Eye. -------------------------------------------------------------------------------------------------- Animil Number: IR-71542 Be%: Kale SFDUP' ( 1) CONTROL 0 ppii Fate: (Week=106) TerminalSacrifice MicroscopicDbservations: -No visiblelesions. MicroscopicObservations: Adrenal -Cortical vacualatidn, oultifocal, sild --------------------------------------------------------------------------------------- Species: Rat Project Number:0281CROO12 Summarized STAR Page: 42 206 SuatirizedSingleTabulatedAnimalReport (con4.inued) Individual@Macroscopic and Microscopicobservat@ons Riker Laboratories,Inc. 3m FC-143:Two Year Oral ToxicitY-OncogenicitSytudy in Rats Table: 4' -------------------------------------------------------------------------------------------- Animal Number: IR-3548 Sex: Male Group: 1) CONTROL 0 ppi Fate: (Week=106)TerminalSacrifice ?2icroscapiOc@servallions(continued): Kidney Liver Lung Lyipl No4@e(sesente-ic) Parathyroid F;tuitary Thyro@id -Chronicprogressivene;@ropathy,sild -Portaiscnonucleacre'linfill,raie,'sild He;atc:ytveaciclationp,eriportalo,iIU4 Nepatocytevicuoli"iD-',Aiaitedto Gne area of liver. -Vascularaineralizat@o.-a,i,ld Alveolarsacrophiges,minimal Perivasculasronanuclearinfiltrate,aild -Hemorrhage,aild -Not examined,not in plane of section -Cyst,pars distalis -C cell carcinoma Ti@efollow@Angtissueswere found to be within normal limits: Brain,SpinalCord, Bone Marrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UriniryBlidder,Aorti,Testis/EpididysisP,rostate,Trachei,Esophagus,Pancreas, SalivaryGland, Eye. ---------------------------------:------------------------------------------------------------ Animal Number: IR-T,549 Sex: Mile Group: 1) CONTROL 0 ppe Fite:(Weeki 96) Sacrificedin extreiis MacroscopicObservations: Fi'Uuilliry Liver P,4,croscop;Oabcservations: Heart Liver Lung Pir,ithyroid Pituitary Spleen Thyroid -Hemorrhagicmiss, 1.4 x 0.8 ca. -Slightlypile -Myocarditis,chronic nonsuppurative, oultifocalm,ild -Nepatocytevacucla'Lions,ultifocal.s,ild -Yascularmineralizations,ild Alveolarsacrophages,minimal -Not examined,missing -Adencea -Hemosiderosis,mild -Not exam@ine,@lm,issing The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCard, Done Marroos,Kidney,Stomach,Small Intestine,Large Intestine, Urinaryilidder,Aorta,TestistEp4didy2isP,rostate,Adrenal,Trachea,Esophagus, Lymph Node (aesenteric),Pancreas,SalivaryGland,Eye. --------------------------------------------------------------------------------------------- species:Rat Project Number: 0261CROO12 Summarized STAR Page: 43 207 SummarizedSingle TabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerL&bCritDries,Inc. 3p. F"-143:To: Year Or&! Toxicity-OncogenicitSytudy in Rats Table: 2 ----------------------------------------------------------------------------------------------- Animal Number: IR-3.@52 Sex: Male Group: t 1) CONTROL 0 pps Fa'Le:(Neek=106) TersinalSacrifice MacroscopicObservations: Spleen MicroscopicObservations: Adrenal I.id.-ei Live- l@u@g Pancreas Parathyroid Pituitary Prostate Spleen -Circularraisedles-@er.!,..1cc dia. -:ortici!vacualitiono,u'Atifo:isli.l,d P.edullircyellhyperplisia,localareas, moderate -flhronipcrogressivenephrcpithy,moderate -Portalsonenucleacrelliniiltratev,ild Portalbile duct proli4erationm,ild -Vascularsinerilizitionm,ild Pneumonia,interstitialc,hron;lco,ulti@ocal, tild -Acinaratrophy,sild -Not examined,not in plane of se--'6ion -Adenati -Prostititisa,cute,suppurative.c,@lt -Hesangiosarcoma The followingtissueswere foundto be withinnormallimits: Brain, Spinal '@'ordB,one Marrow, Heart, Stomach',SmallIntestine,Large Intest;ne, UrinaryBladder,Aorti,Testis/EpididysisT,h,yroid,Trachea,Es:phagus,Lymph Node (sesenteric), S-a-i-@-v-ar-y-E-l-a-n:--,--Eye. ----------------------------------------------------------------------------------- Ar,;;miNlue6.er: Tr,cv Sex: Male GroL-p: 1) CORTRO'.0 ppt i-ite:(keei= BE)FoundDeal Macrcsco,-icObservations: Ad-er;al Micros-,o,@,@@icObservations: Adrenal -Leftenlargedby a I co dii. miss. -Sinusoidalectasia,cortex,mild Pheochrosacytoma,benign, unilateral Eye -Not examined,missing Heart -Myocarditis,chronicnonsuppuritive, oultifoca'si,ld Kidney Large Intestine @Chrenicprogressivenephropathy,sild -Not examined,missing Liver -Portalsononucleacrellainfiltrates,ild Portalbile duct proliferationm,oderate Nepatacytevicualationo,ultifocils,ild Necrosis,oultifacilm,ild Lung -Vascularsineralizationm,ild Lymph Node (sesenteric) -Not examined,missing -------------------------------------------------------------------------------------------- Species: Rat Project Number: 02BICROO12 Summarized STAR Page: 44 208 SuagarizedSingle TabulatedAnimalReport (conta inued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-1470:Two Year Oral TOxi'.itY-OncogenicitSYtudy in Rats Table: 2 --------------------------------------------------------------------------------------------- Anisal Number: IR-3'j'j3 Sex: Male Fate: (Week= 88) Found Dead Group: ( 1) CONTROL 0 pps Otservations(continued): Pancreas Pi'6uitiry Sal@vary Gla-,d SaailIntestine -Not examined,missing -Cyst, pars distil@Ls -No' examined,oissi-ig -Not,examined.,missing The follow4li'gL@ssuesmere found to be Nithin normal limits: Brain,S;inalCord',Eane Mirrow, Spleer, Stomach, Urinary Bladder, Acri.-aT.esl-is!Epi,.ii4wyr@ls, Prostate,Thyroid,Parithyr-,41Tdr,achea,Esophagus. --------------------------------------------------------------------------------------------- Ani3a! Nuater:IR-I.f.5c4 Sex: MaIle Srou;: 1) CONTROL 0 pps Fite: (Week.=1061TerminalSacrifice Macroscc;icObservations: M@Icros,.opi@O.bservations' Kidney Liver Lung Parat@yraid Pros',-ate -No visiblelesions. -Chronicprogressivenephropathy,moderate -Portals&ononuclearcell infiltrate,o@ild Portalbileductproliferationm,ild Nepatocytealteration,viclolated,mild -Alveolarear-rophageso,ultifocil,moderate Perivascularmanonucleirinfiltrate,moderate Vascularsineralizationm,ild Pneumonia,interstitialc,hronic,sultifocil., moderate -Net exi2ined,not in planeof section -Prostatitis,acute,suppurative,moderate The fo"Aow;.ngtissues were foundto be withinnormallimits: Brain, Spi.-,iar.aord@ Rare Narrow,Spleen,Heart, Stomach,Small In4l-estinLea,rge Intestine, Urini-y Bladder,Aerta, Tes'6is/Epididya;Psi,tuitary,AdreitalT,hyroid,Trachea,Esophagus, Lyaph Node @lsesenteric)P,ancreas,Salivary61and, Eye. -------------------------------------------------------------------------------------------- An;AsilNumber: IR-3'jj'5 Sex: Male Group: ( 1) CONTROI.0 ppe Fate: (Week=102) Sacrificedin extrea;s MicroscopicObservations: Kidney Drin4iryBladder -Pile, enlarged;a@Aldhydronephresis. -Enlirged,fluidfilled,wallappears hemorrhagic. MicroscopicObservations. Adrenal -Corticalvacuolation.localareas, moderate -------------------------------------------------------------------------------------------- Species: Ral, Project Number: 02BICROO12 SL-saarizedSTAP Page: 45 209 Suuirized SingleTabulatedAnisilRe;Drt(cortinlied) IndividualMacroscopicand MicroscopicObservations Rike, Liberatories,in@,.3M FE-1414:Two Year Ol,alToxicity-OncogenicitSytudy in Rits Table: -------------------------------------------------------------------------------------------- Animil Number: IR-3cr5 Sex: mile 6roup: 1) CONTROL 0 ppe Fate: (Week=102)Sicri4icedin extresis Mi:roscopicO@servitions(.continuew4"'. Aor,6i Heart Kidney Liver Lung Pirithyroid Prostate SmialaIntestine Spleen Stoia:t UritiryBladder -Mineralizatiosni,ld -Myocarditis,chronicnonsup;uritive, oultifocals,ild -Nephrosis,tubular, moderate Papillarynecrosis,moderate Hydronephrosis,mild Tubulesdilatedwith low, bisephilit epithelium,scatteredsine@a!izedtubules. -Portilbileductproliferationm,ild Hepatacytevacuclation,sultifocal,sild -Yascularmineralizations,ild Alveolarmacrophiges,mild Hemorrhage,focil, mild -Not examined,not in plane of section -Prostatitisi,cute,suppuratives,ild Edema, intersititialm,oderate -Withinnormallimits Fewer thin protocol number -Hesos4iderosism,ild -Edema, suboucosal, moderate -Hemorrhage, marked Epithelialhyperplasia,simple,diffuse,&4,ld Cystitis,acute,moderate The t@ssueswe-e found to be withinnormallimits: Brain,Sp@lna'CAord, BoneNarrow, Large Intestine,Testis/EpididynisP,ituitary,Thyroid, Trac@,.eaE,scphigus,Lymph Node (sesenteric),Pancreas,SalivaryGland, Eye. -------------------------------------------------------------------------------------------- A-i'malNumber: IR-3556 Sex: Ma.e group: 1 1) CONTROL 0 pps Fite: (Week=106)TerminalSac-i4ice MicroscopicObservations: Adrenal -Rightenlargedby mass, 2 x I cm. MicroscopicObservations: Adrenal -Carcinoma,cortical,unilateral Largeneopliss,mostlynecrotic. Cells foamy, polyhedralarrangedin cards and sheets. Highmitoticactivity.Multiple lung metastises. Kidney -Chronicprogressivenephropithy,mild Liver -Portalsonanucleacrellinfiltratem,ild Portalbile ductproliferationt,ild -------------------- - -------------------------------------------------------------------- Species: Rat Project Number: 0261CROO12 Summarized STAR Page: 46 210 SummarizedSingle TabulatedAnisai Report (continued) individualMicroscopicand Microscopicobservations RikerLibrraloriesI,nc. 3H FC-143:Two Year Ora! Toxi,,ity-OncogeniciSttyudy in Rits Table: 2 --------------------------------------------------------------------------------------------- Animal Nuater: IR-3556 Sex: Male Group: ( 1) Cr.'N',R0olp,ps Fite: (Week=106)TerminalSacrifice Microsco;icObservations(continued!: Lung Parat@.yroie -Pniuacniii,nterstitialc,hronic,oultifocal, sild Metastatic neoplasm Perivascularsononlclearin4-.1trates.ild Vascularminerali.,it'lsoiil,d -Not examined, not in plane Of SECt4,Gn The 4o!looiiA."-i@sgsues were found to be within normal,limits: Brairi,SpinilCord, Bone Marrow,r.pleenH,eart,Stomich,Small Intestine,Large Intestine, Llr@inarBylidder,Aarti, Test@As/Ep@ldidytPirso,state,Pituitary,Thyroid,Trachei,Esophagus, '6yop@Nr,,,(esesen4.-er;iPcaln,creas,Salivary Gland, Eye. ---------------------------------------------------------------------------------------------- A,@,iikNiulmber: IR-'V",!7 Sex: Mile Group: F,'Le:(Week= 106) TerminalSacrifice 1) CONTROL 0 pps MacroscopicObservations: fl4croscopicObservat4kons: kidney Liver Lung Thyroid -No visiblelesions. -Chronicprogressivenephropathy,aild -Portalsononu,-.Iecaerll in4iltrate,o@Lld Hepatacytealteration,Yicualiteds,ild -Vascularmintralizitionm,ild Pneumonia,interstitialc,hronic,ou'Ati4ocal, mild -HyperplasiaC, cell,sild The followingtissueswere foundto be withinnormal limits: Brain,SpinalCard, Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Pituitary,Adrenal,Parat.l@yraiTdr,ac,@ea, Esophagus,Lymph Node (mesenteric),Pancreas,SalivaryGland, Eye. --------------------------------------------------------------------------------------------- Animal Number: IR-'44!8 Sex: Male Group: ( 11 CONTRO'.0 ppi Fi'Le:(Meek=106) TerminalSacrifice MicroscopicObservations: Pituitary -Raisedmass, 0.9 co dia. MicroscopicObservations: Adrenal Kidney -Sinusoidalectasia,cortex,sild -Chronicprogressivenephropathy,sild Calculus,pelvic,minimal Liver -Cystaid degener&16m-,i focal, minimal ------------------------------------------------------------------------------------------------- Species: Rat Project Nuaber: 0281CROO12 Summarized STAR Page: 47 2 11 Sunirized SingleTabulatedAnimalReport (Continued) IndividualMicroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3" FC-143:Two Year Oril Toxicity-OncogenicitSytudy in Rats Table: 2 ------------------------------------------- --------------------------------------------Animal Number: IR-3558 Sex: wale Group: ( 1) CONTROL 0 pps Fate: (Week=106)TerminalSacrifice MicroscopicObservations(continued): Piral,hyroid Pitui'6,ary Spleen -hoL examined,not in plane of section -Adenami -Hemosiderosis,sild The followingtissueswere foundto be withinnormal limits: Brain,Spina'&Cerd, Bone Narrow,Heart,Lung, Stomach,Small Intestine,6arge Intestine, Llr@knarBylad@er, Aorta, Testis/Epididys@isP,rostate, Thyroid, Trachea,Esophagus, Lymph Mode (sesentericl,Pancreas,SalivaryBland,Eye. ---------------------------------------------------------------------------------------------Anisil Number: IR-3560 Sex: Male Group: 1) CONTROL 0 pps Fate: (Week= T@s)Sacrificedin extresis MacroscopicObservations: Brain Lung Sp'leer, Lymph Wade (abdominal) Liver MicroscopicObservations: Brain L@lver Lung Lymph Ncdo (sesenteric) Small&Intestine Spleen -Focalcircumscribeddark area,dorsa', surface,left cerebralhemisphere (0.1c&e dia.)and lateralsu-faceof right cerebralhemisphere(0..1ca -ulia.) -Darkred diffuseouttling,all lobes;red frcthyexudateat trachea. -Enlarged -Hepaticand renil nodes enlarged. -Pale, appearsenlarged. -Abscess,mild Hemorrhage,sultifocal,moderate -Malignantlyaphoma,histiocyt;lc -MalignantlyaphDGa,histiocytic Hemorrhage,diffuse, marked Necrosis,local areas,marked -Hemorrhage, minimal -Within normal,l@,a4Ats Fewer protocol number -Hesitop.-iesiesx,tramedLIlary,increased, . marked The followingtissueswere foundto be withinnormallimits: SpinalCord, Done Marro%,Kidney,Heart,Stomach,Large Intestine,Urinary Bladde',Aorta, Testis/EpididysisP,rostate,Pituitary,Adrenal,Thyroid,Parathyroid,Trachea,Esophagus, Pancreas,SalivaryGland, Eye. ---------------------------------------------------------------------------------------------- Species:Rit Project Number*.0261CROO12 Summarized STAR Page: 48 2 12 SummarizedSingleTabulatedAnilialReport (continued) individualMacroscopicand MicroscopicObservations Riker Laboratories,Inc. TIM FC-1411:Two Year Oral&Toxic@,ty-Oncogeni,4ASttYudy in Rits Table: 2 -------------------------------------------------------------------------------------------- Animil Number: IR-11561 Se.-:Male Group: 1) CONTROL 0 pps Fate: (keek=106) TerminalSacrifice Mac,osco;icObservations: So4t Tissues (leg': kidney MicroscopicObservations: Adrenal Bone Bone Marrow Kidney Large Intes+ine Liver Lung Parathyroid Piluil@a-Y Spi,-ial16"or4y spl4een Testis/Epid4adysis Thyroid -Rightand lefthindpawand right forepaw swollen. -Rightkidneypolycystic. -Corticalvicualation.o,ult@focal,mild Medullarycellhyperplisiio,ultifocals,ild -Arthritiss,ynovitisj;oints,hindleg, foreleg,marked -Not examined,missing -Chronicprogressivenephropathy,a4,ld Pelvicmineralizitionm,ild Cyst,cortical,unilateral,Barkel. -Nemitodiasis,color. -Portalsononucleacrell infiltrates,i',d Portalbileductproliferationi,'Lld -Perivasculasroponucleirinfiltra*lem,ild YascL-laarirerilizations,ild Pneumonia,interstitialc,hronic,oult4,focal, sild Hemorrhage,local areas, moderate -Not examined,missing -Adenosa -Not examined,missing -Hemosiderosis,mild -Tubule atrophy,aspereatagenesis,moderate Polyarteritism,arked -Not examined,missing The followingtissueswere found 'Labe withinnormal limits: Briin,Heart..Stomach,Small Intestine,UrinaryBladder,Aorta,Prostate,Trachea,Esophagus, Lymph hode (sesen'Leric)P,ancreas,SalivarySlind,Eye. --------------------------------------------------------------------------------------------- Anisil Number: IR-3562 Sex: Male Group: ( 1) CONTROL 0 ppm FI*LE:fneek=106) TerminalSicri4ice MacroscopicObservations: Skin -Raisedulceratedin4liesedlesion,rightrear foollpa,61. Spl&eer, -Severalpale foci. MicroscopicObservations: Adrenal -Nodularhyperplasia,cortex,unilateral, moderate --------------------------------------------------------------------------------------------- Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 49 2 13 SummarizedSingleTabulatedAnimal Report (continued) IndividualM,acroscopicand microscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Toxicity-oncogenicitSytudy in Rats Table: --------------------------------------------------------------------------------------------- Animal Number: IR-7@562 Sex: Mile Group: 11 CONTROL 0 ppi Fate: (Week= 106) Terminal Sacrifice 0.@IcroscapicObserv&16-@lons(continued): Heart Kidney Large Intestine Liver Lun; Parathyroid PitiuVi'6yary Sal. if Gland Skin -Myocarditis, chronic nonsuppuritive, sultifocal,mild -Chronic progressive nep.l.ropithym,ild -Wesitodiasis, colon -Portal acnonucleircell infiltrate,silc -Vascular mineralization, sild Pneumonia, interstitial, chronic, sild Perivasculir monanuclear infiltrate, sild -Not examined, not in plane of section -Adenoma -Not exiiined, missing -Pododersatitis, ulcerative, h@lidleg,marked ';hefol,lovirgtissues were found to be within normal lisi,,s: Brain, Spinal Cord, Bone Narrow, Spleen , Stomach, Siall Intestine, Urinary Blidder, Aorta, Tes'lis/Epididysis,Prostate, Thyroid, Tr' achea, Esophagus, Lye,h Node iiesenteric), Pancreas, Eye. ------------------------------------------------------------------------------------------------- An@eall N6-mber: IR-"'563 Se-.: Male Fa-@le:(Neek.=1(16)Terminal, Sacr4fice Grou@F: 1) CONTROL 0 ppe Micros.rop@4,@Obseryalliors: Thyro-t -One side enlarged, I x O.B cc. Skin Microscopic Observations: -Mass, 1.7 x 1.4 cc, dorsal area. Adrenal -Cortical vacuolation, oultifocal.,o4Ald Sinusoidal ectas'a, cortex, minimal Brain -Astracytoma, benign Poorly defined lesion in basal area of cerebrum. Tumor cells spindelate. heart -Myocard4aluis,chronic ndnsuppurative, ault@facal, mild Kidney Liver -Chro;ic progressive nephropithy, moderate -Hepatacyte alteration, basophilic, moderate -Portaliiananuclearcell infiltrate,mild Nepitacyte alteration, vicualated, moderate Necrosis, local areas, moderate Lung -Vascular mineralization, a@a*ld Perivascular manonuclear infiltrate, oil-wl Pancreas -Acinar atrophy, marked Pituitary -Adenosa Prostate -Prostatitis, acute, suppurative, moderate ----------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 50 2 14 SummarizedSingle TabulatedAnimal Report (continued) IndividualRacroscOPitand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-147.:Two Year Oral ToxicitY-OncogenicitSYtudy in Rats Table: 2 ----------------------------------------------------------------------------------------------- Animal Number: IR-3563 Sex: hale Group: ( 1) CONTROL 0 ppe Fate: (Neekz106)TerminalSacrifice MicroscopicObservations(continued): Ski," Thyroid -Keritoacanthonib,ack -C cell carcinoma The folicitirt,i;ssues*ere foundto be withinnormallimits: SpinalCo-d, Bone Marrow,Spl.eer.S,tomach,Small Intestine,Large Intestine,UrinaryBladder, Tes'L44s/EpididyeiPsa,rathyraid,Trachea,Esophagus,Lyaph Mode (sesenteric), Salivary61and, Eye. -------------------------------------------------------------------------------------------- A,-,isiNlu,mber: l@-."164 Sex: Male Group: Fate: (Week=106)Terminalc.acrifice 1) COKTROL 0 ppe 4a.,roscopinw ,tservitiors, Kidi-,ey Mi:rcscapic016'servitions: Adrenal Bone Marrow Heart V*.diney Liver Lung. Pancreas Parat.k@yroid Pituitary SalivaryBland Spinal Card Testis/Epididysis -Pale area in cortexa; one k4dney. -Corticalvacuol*atioru.l,itifoca,o.ild Medullarycellhyperplasia,oultifoca',, moderate -Not examined,missing -Myocardi'6isc,hronic nonsuppuri4@ive, au!t@lio,,amli,ld Myocardialfibrosis,oultifocalc,ild -Chronicprogressivenephropathy,moderate Cyst, unilateral,moderate Areaof sultiloculicrystsin cortexwith lipid change in surroundingparenchyma. -Portalbile duct proliferations,'sld Hepitocytevicualat@oro,u,ltifocal,mild Portalsonenucleacrell infiltrates,ild -Vascularmineralizationi,k'ld -Not examined,missing -Not examined,not in plane of section -Adenosa -Not examined,missing -Not examined,missing -Mineral4.,,ation, mil',d The followingtissueswere foundto be withinnormallimits: Brain, Spleen,Stomach,Small Intestine,LargeIntestine,UrinaryBladder,Acrta,Prcstate, Thyroid,Trachea,Esophagus,Lymph Made (sesenteric),Eye. -------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROOIA' Susairi.zedSTAR Page: 51 2 15 Susa&irw 4Szien4glTeabulatAend4 ;aiRleport(continued) IndividuaMlacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FC-143:Two Year Oral Toxicity-oncogeniciSttyudy in Rits Table:2 -------------------------------------------------------------------------------------- AnisalNumber: IR-.7565 Sex: male Group: 1 1) CONTROL0 ppi Fate: (Week= 84) FoundDead MicroscopicObservations: Skin Liver MicroscooicObservations: Adrenal Acrta Esophdgus Eye l'idney Large Intestine Liver LL,r,.g Lymph Node (iesenteric) Pancreas Pirithyroid Pituill-ary Prostate SalivaryGlind Skin EsallIntestine Spleen Thyroid Trach;a Ur@iniryBladder -Large Bass, 7 1 7 ca.,scratal area. -Pile -Not examined,missing -Not examined,missing -No4,examined,missing -No diagnosis,inadequatesection -Chronicprogressivenephropithy,mi"d -No diagnosis,inadequatesection -Nepitacytevacualatio,noultifo-A!, Necrosis,oultifacalm.o,derate -Vascularsinerilizat@iosni,ld -Not examined,missing -Not examined, missing -Not examined,missing -Not examined, missing -Not examined,missing -Not examined, missing -Liposarcosa The scroluamliss mis composedof large, vacualitedmononucleacrells. The degreeof autdlysis ide diagnosiss3sewhatuncertii,.. -Not examined,missing -Hesitapaiesise,xtrisedulltryi,ncreased. mild -Nct ex&4ired,missing -Not examined,missing -Not examined,missing The follow@ngtissueswere foLn4wto be iii4lbnionr.mallimits: Era44.Sip,iral'@ard,Bone HirratiN,ei?-tS,tomach,Testis/Epididysis. ---------------------------------------------------------------------------------------- Animal Number: IF,-3566 Sex: Mile Group: ( 11 CONTROL0 ppe Fate:tweekz106)TerminalSicrifice MacrosrcpicObservations: Pituitary -Smalldark lesion. MicroscopicObservations: Adrenal -Withinnormallimits One of piirpresent Kidney -Chronicprogressivenephropathys,ild ---------------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 5@', 216 SustarizedSingleTabulatedAnimalReport (continued) Indiyidual Macrcsct)picand 4icroscopicObservations RikerLabcritoriesI,nc. 3P FC-143:TitoYearOr&! 7axicity-oncogenicitSytudy in Rits Table: 2 --------------------------------------------------------------------------------------------- Animal Number: IR-3566 Sex: Vale Group: ( 1) CONTROL 0 ppe Fate: (Weeks106)TerminalSacrifice MicroscopicObservations(continued): Liver Lur.g Fincreas Pira'Lhyrc@i,ul Spleen -Part&!so-.tonuclceealrl infiltrates,ild Portalbileductproliferations,ild -4asculariinerili-,atiomni,ld PerivascL,Iasronanuclearinfiltrate,m@ld -Polyarteitis,moderate -Not examined,not in plane of section -Hemoside.rosiss,ild The 4olIDNin;tissueswere foundto be withinnormallimits: Brain, C,-,rdE,ane Mirrow.L,arge Intestine,UrinaryBladder,Aorta,Testis/EDididytis, PF.cstite,Pituitary,Thyroid,Trachea,LyaphNode (sesenteric)S,alivaryGland,Stomach, Stall'Intest'nE,Heart, Eye, Esophagus. ---------------------------------------------------------------------------------------------- A,-,@loaNlueler: IF-'@54-7 Sex: Male Group: File: (Weeiz106)Teraina!Sacrifice 1) CONTROL 0 ppe MicroscopicObservations: Skirt Spleer, Microscopic Observations: Adrenal Kidney Liver Lung Skin Splieer, -Raisedpipillosatypemass an bickt raised inflassedlesion,rightrear 4cotpad. -Two pale foci. -CorticalvacualitionB,ultifecalm,i.ld Nodularhyperplisiic,ortex,focal,mild -Chronicprogressivenephropathy,moderate -Portalsonanuclearcell'i&nfiltrate,mild -Yascularsine-ilizations,ild Alveolar sacrophiges,minimal Perivisculasrononulearinfiltrate,minimal -Papillona,back Pododereatitisu,lcerative,hindleq,marked -Ne-.rosisl,ocal areas,moderate The followingtissueswere foundto be withinnormal limits: Briir,,SpinalCord,Bone Narrow,Heart,Stomach,Sea!l Intestine,Large Intestine, UrinaryBl&idderA,orta,Testis/EpididysisP,rostate,Pituitary,Thyroid,Pirathyroid,Trachea, Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryGland.,Eye. ----------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 53 217 SummarizedSingleTabulatedAnimal Report (Continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3M FC-143:Two Year Oral Toxicity-oncogenicitSytudy in Rats Table: 2 -------------------------------------------------------------------------------------------- Animal Number: IR-3569 Sex: Male Group: 1) CONTROL 0 ppe Fate: !Week=106)TerminalSacrifice MicrcscapicObservations*. Kidney Microscopic Obserya"6ions: Adrenal Heart Kidne-f Liver Lung Pituitary Testis/Epididysis -Bilateralleynlarged;pale,pitted. -Corticalvacuclation,focal,minimal Sinusaidalectisii,cortex,mild Medullarycellhyperplasit,oultifo.,aeli,ld -Myocarditis,chronicnonsuppurativel, oultifocalm,ild -Chronicprogressivenephropathy,marked -PortilBononucleacrell infiltrates,ild Hepatocytevacualal,iono,ultifocil,mild -Vascularmineralizationm,ild Perivasculasronanuclearinfiltrate,oild -Hyperplasiif,ocal,parsdistilis,mild -Polyarteritism,oderate The followingtissueswere foundto be within normallimits: Brain,SpinalCord, Done Narrow.,Spleen,Stomach,Small Intestine,Large Intestine, Urinary Bladder,Aorta, Prostate,Thyroid,Pirathyraid,Trachei,Esophagus, Lymph Nolve(sesenteric),Pancreas,SalivaryGland,Eye. ----------------------------------------------------------------------------------------------- Animal Number: IR-')571 Sex: Male Group: 1) CONTROL 0 ppe Fite: lweekz106)TerminalSacrifice MacroscopicObservations: Liver Kidney Mesentery MicroscopicObservations: Adrenal Heart Kidney Liver Lung Resen'6-ery Pancreas Parathyraid Pituitary ---------------------- -------------- ------ -Pale -Pile,pitted,enlarged. -4esente;icvesselsthickened -Corticalvact;olationf,ocal,minimal -Myocarditis,chronicnonsuppurative., sultifocilm,inimal -Chronicprogressivenephropathy,marked -Portal menonuclear cell infiltrate, 2ild -Portalbile duct prcii4eration,mild Nepatecyte vicuelation, oultiiacal, mild -Vascult, mineralization,aild Periy,iscularsonanuclear infiltrate, minimal -Polyarterit4.s,marked -Polyarteritis, marked -Not examined, not in plane of section -Not examined, missing --- -- --------------------------- -- ---------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 54 2 18 SusaarizedSingle TabulatedAnimalReport (Ccntiflued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FE-143,Two year Oral Toxicity-Oncoge.-tiSctiutdyy in Rats Table: 2 --------------------------------------------------------------------------------------- Animal Number:IR-3571 Sex: Male Group: ( 1) CONTROL0 ppe Fate: (Week=106)TerminalSacrifice M@i,-roscapOilcuservation(scontinued): StallIntestine Splee@-I Testis/Epididy2is -Polyarteritise,esen'lerymgarked -Nesosiderosisa,ild -Polyar-*,eri'6miasr,ked The icilowingtissueswerefoundto be withinnormallimits: Briin,SpinalCor4uB,one Marrow,Stosach,LargeIntestine,UrinaryBladder,Aorta,Prostate, T,@yro@4,Turla,chea.,Esophagus,,Lymph Node (sesenteric),SalivaryGland, Eye. ---------------------------------------------------------------------------------------- Ar,@ima'N,uater: IR-'.57-A@ Sex: Kale Group: 1) CONTROL 0 ppe Fite:(WEekz106)TerminalSacrifice MicroscopicObservations'. Micros:opicObservations: Kidney Liver Lung Pancreas Parathyro-l'.1 Stomach -No visiblelesions. -Chronicprogressivenephropathy,minimal -Portalannonuc'Aecaerllinfiltratea,ild Portalbileductproliferatioani,ld Hepatc:ytveacuclations,ultifocalo,ild -Vascularmineralizitionm,il&d -Hyperplisii,sletcell,moderate -Notexamined,not in planeof section -Not examined,missing The followng tissueswerefoundto be withinnormallimits:, Erain,SpinalCord,Bone MirrDW,Spleen,Heart,Small IntestineL,arge Intestine, Ur4naryBliA.,.IAeorr,ta,Tes'6-is/EpididysPirso,state,P4AtuitiryA,drenal,Thyroid,Trachea, Esophagus,'@yop@N!ode (sesenteric)S,alivaryGland,Eye. --------------------------------------------------------------------------------------- Animal Number: IR-.1573 Sex: Male Group: 1) C04TROL 0 ppe Fate: (Week=104w)Teraina!Sacr4lfice MicroscopicObservations: Pancreas -Smallcircularpale mass,0.5 ce d-*Ia. MicroscopicObservations: Adrenal -Corticavlacuolitioio,ult4liocasii,ld Pheo:hrosocytomab,enign,unilateral Kidney Large Intestine Liver -Chronicprogressivenephropathy,aild -Nea&tDdiasisc,olon -Nepatocytaelterationv,acuoliteds,ild Repatacyla.leterationb,isaphilicm,ild Portalbileductproliferatiomni,ld Repatocyl6veacualationo,ultifocalo,ild Portalmanonu-61ecierll infiltratem,ild -------------------------------------------------------------------------------------- Species:Rat Project Number: 0281&v@R0012 Summarized STAR Page: 55 219 Sumirized SingleTib4latedAnimalReport (continued) IndividualMacroscoPicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143:Two Year Oral Toxicity-OncogenicitSytudy in kits Table: 2 --------------------------------------------------------------------------------------------- An'asilNumber: JR-3573 Sex: male Group: ( 1) CONTROL0 ppe Fite: tweek=106)TerminalSacrifice Mi:roscopicObservationsiCDntinued): Lung Pancreas Par&'Lhvroid -Yascularminerali,.atiorni,ld Perivascularsononuclearin4iltrate,sild -A,-iniartrophy,mode-ite Isletcell adenosi -Not examined,not in plane of section The followingtissueswere foundto be withinnormallimits: Bra-Aric,4.o@inCia'rAd, Bone larrow, Spleen,Heart, Stomach,Small Intestine,Uriniry Bladder, Aorti,Testis/Epid-ldysiPsr,ostate,Pituitary,Thyroid,Trachei,Esophagus, Lymph Node Isesenteric)S,alivaryBlind,Eye. - -------------------------------------------------------------------------------------------- Ar.4'saNlualer' IF-7@!74 Sex. .4ale Group: Fate: (Weekz 99) Sacrifice,i.n'extresis 1) CONTROL 0 pps Racro5copicObservations: Skin -Ulceratedrightand lefthind footpads; circularwhite subcutaneous@ass, 1.5ce dia.,in rightinguinalarea. Thorax(internal) Heart Liver Kidney Testis/Epididymis -Filledwithfluid. -Slightlypaleand fliccid. -Slightlypale -Pale and pitted;1.5 ce cyst in r@.gh4kLidney. -Testes small MicrOSEDPIC Observations: Adrenal Aorta -Corticalvacuclationo,ultifc)ca'o4',.Id -Necrosis,local areas,moderate Uniformintisalnecrosiswith react4ve cellularinfiltrate. Heart -lyDcardi'6isc,hronic nonsuppurit4@ve, sultifocilg,ild Kidney -Chronicprogressivenephrdpathy,marked Cyst,unilateral,marked Liver -Portalsonanucleacrellinfiltratea,ild Portalb4lleduct proliferations,ild Lung -Pneumonia,interstitialc,hrot,.idci.f,fuse, moderate Periviscul.siornanucleairn4iltritem,ild Edema, local areas, marked Lymph Node (mosenteric) -Not examined,missing Pincre,is -Acinar atrophy,mild Parathyroid -Not examined,not in plantof section ------------------------------------------------------------------------------------------- Species:Rit Project Number: 0261CROO12 Summarized STAR Page: 56 220 SummarizedSingle TabulatedAnimalReport (continued) IndividualMicroscopicand Microscopic Observations RikerLaboratoriesI,nc, 3m FC-141.T:wo Year Oral ToxicitY-Oncogenicity Study in Rits Table: 2 ----------------------------------------------------------------------------------------------- Animal Number: 1R-3574 Sex: Male Group: ( 1) CONTROL 0 ppe Fate: theek= 99) Sacrificedin extreo;ls MicroscopicObservations (continued): Pitt;4,'Lary Prostate Sil-vary Glard Skiii Testis/Epididyeis -Cyst, pars intersedii -Prostititis,acute, suppurative,moderate -Not examined, aissin; -Fibroma, subcutaneous..inguinil Podadereatitis,ulcerative,hindleg, marked -Tubule atrophy,ispersitogenesis,bilateral, moderate The folillow-Itnigssues were found to be within normal limits: Brain, Spinil Cord, Bone Marrow, Spleen, Stomach, Small Intestine,Large Intestine., Urinary Bla,.IderT,hyroid, Trichea, Esophagus, Eye. -------------------------------------------------------------------------------------------------- Anisil Nuel@er: IR-'41@76 Sex: Mile Group: Fite: ;Week= 55) Sacrificedin extresis 1) CONTROL 0 ppe Microscopic Observations: Si.- n Abdome.-t.interril) Microscopic Observations: Kidney Lung Parathyro@ld Spleen Urinary Bladder -Moist area around genital papilla. -Large amountof gas in gastrointestinal, tract; no food in stomach. -Pelvicminerilli.,atiomni,ld -Hemorrhigf!d,iffuse, marked -Not examined,not in plane of section -HeacsiderDsis,sild -Not examined, missing The followingtissueswere fouid to be within narmil limits: Brain, Spinal Cord, Done Narrow, Liver, heart, Stomach, Small Intestine.,Large Intestine,Aorta, Testis/Epididyais,Prostate,Pituitary, Adrenal,Thyroid,Trachea,Esophagus, Lymph Node itesenteric),Pincre4is,Salivary Gland, Eye. -------------------------------------------------------------------------------------------------- AnisiltNumber: IR-3577 Sex: Mile Fite: (Week= 106) TerminalSacrifice Group: 1) CO.4TRO'@0 ppt Microscopic Observations: -No visible lesions. Microscopic Observations: Kidney Liver -Chronic progressive nephropithy, moderate -Portalsonanuclearcell infiltrate,mild Portalbile duct proliferation,mild Hepatocytevicualation,oultifocal.s,ild Cystoiddegeneration,oultifocil,mild Nepitacytealteration,vacuolated,mild ------------------------------------------------------------------------------------------------ Species: Rit Project Number: 0281CRDOI'41 Summarized STAR Page: 57 221 SummarizedSingle TabulatedAnimalReport (continued) Individual Microscopic and Microscop@IcObservations RikerLaboratoriesI,nc. 3H FC-143: Too Year Oral Toxicity-OncogenicitYStudyitRats Table: ---------------------------------------------------------------------------------------- Animal Nusher: IR-3577 Sex: Male Fate: (Week=106) Terminal Sacrifice Group: ( 1) CONTROL 0 PPA MicroscopicObservations (continued): Lung Mesentery Pancreas Seal! Intestine Sple;n Thyroid -Vascularmineralization,sild -Polyarteritis,marked -Polyarteritis,marked -Polyarteritis,sesentery,moderate -Reacsiderosis,sild -Cyst,colloid,sild The follcwi.@gtissues were found to be within normal limits: Brain, Spi.-.aC'oArd, B.-reNarrow, Heart, Stomach, Large Intestine,Urinary Bli4uder,Aorta, Tes4.is/Epididye@lPsr,ostate, Pituitary, Adrenal, Parathyroid,Trachea, Esophagus, Lymph Node (sesenteric),Salivary 61and, Eye. ------------------------------------------------------------------------------------------------- Animal Number: IR-1.578 Sex: Male Fate: (Week= 106) Terminal Sacrifice Group: 1) CONTROL 0 p;a Macroscopic Observations: Pituitary Skin Microscopic Observatiops: Kidney L@.Yer Lu7,g Pituitary Prostate Salivary Gland Skin -Hemorrhagicmass, 0.7 co dia. -Raisedulceratedirflassedlesiori,1.5 -,c dia., left hind 4cotpi-WI. -Chronic progressivenephropathy,aild Hydronephrosis,unilateral,moderate Calculipresentin ureter of hydronephratic kidney. . -Portalsonanuclearcell infiltrate,a;,Id Portalbile duct pro',i4erationm,ild -Vascularmineralization,sild Hemorrhage, local areas, moderate -Adencea -Prostatitis,acute, suppurative,moderate -Sialaderitis,chronic,minimal Very minimal lesion, only one duct a-4erted. PDdodermatitis,ulcerative,hindleg, marked The followingtissues were found to be within normal limits: Brain, Spinal Cord, lone Narrow, Spleen, Heart, Stomach, Small Intestine,Large Intestine, Urinary Bladder, Aorta, Testis/Epididyais,Adrenal, Thyroid, Parathyroid,Trachea, Esop,',agus, Lymph Made isesenteric),Pancreas, Eye. ------------------------------------------------------------------------------------------------- Species: Rat Project Number: 0291CROO12 Summarized STAR Page: So 222 SuasarizedSingle TabulatedAnimalReport (continued@ IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 -------------------------------------------------------------------------------------------- Animal Number: IR-TP579 Sex: Male Group: 1) CON7RO'.0 pps Fate: (Week= 86) Sacrificedin extreais Macros:opicObservations: Skin KicroscopicObservations: Kidney Liver Lung Parithyroid Pituitary Ski.n Seall Intestine Spleer Tes'6is/Epididyais -RaisedSass, O.B ca dia. -Raisedpale 2 co dia,aiss in rig@itlateral, lobe. -?.asseen clinicallyon rightside appearsto be healedlesion. -Chronicprogressivenephropathy,marked -Portalbile ductproliferationa,ild Hepitocellularcarcinoma Portalmononucleacrell infiltrates,i,d -Perivasculasronanuclearinfiltrate,vil.4i -Notexamined,not in plane of section -Adenoai -Keratoacanthoaa Skin lesionfrom rightside. -Withinnormal limits Fewer than protocol number -Heaosiderasis,mild -Tubuleatrophy,aspe-aatcgenesisu,n4llaleril, mild Polyarteritism,ild The followingtissueswere found to be withinnormallimits: Brain,SpinalCord, Bone Marrow,Heart,Stomach,Large Intestine,UrinaryBladder,Aorta, Prostate,Adre.-ialT,hyroid,Trachea,Esophagus,Lyaph Node tmesenteric),Pancreas, SalivaryGland, Eye. ------------------------------------------------------------------------------------------------- An4LaalNumber: IR-4.76 Sex: Female Group: 1) CONTROL 0 ppa Fi'Le:(Weei= @15)Sacr4ii,ceidn extrea4as Microscopic Observall@ic-.s: Live, Lymph Node (bronchial&) -Enlarged;mottledyellaomco'lor. -Enlarged Lung Spleen Stomach -Pale -Enlirged -Red pitchy areas on aucosa. Lymph Node (aesenteric) -Erilarg;dand reddened. MicroscopicObservations: Adrenal -Sinusoidaelctasii,cortex,aild ione Narrow -Malignantlymphoma,lyaphocytic Kidney -Malignantlymphoai,lyaphocytic Mineralizationc,ortical,aild ----------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Su*saarizedSTAR Page: 59 223 SumairizedSingleTabulatedAnimalReport (continued) individualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3" FC-143:Two Year Oral Toxicity-OncogeniCitSYtudy in Rits Table: 2 --------------------------------------------------------------------------------------------- Animal Number: IR-4576 Sex: Feiile Group: 1) CONTROL 0 pps Fate: (Week= 2'.)Sacrificedin extresis MicroscopicObservations(continued): Liver Lung Lymp" Node isesente,ic) Parcreas Glar@d S,@ir.alCord S,,,@'leen ,olao. UriniryBladder -4&lignantlyaphosi,lyso@.Ocytic -Malignantlymphomi,lyaphocytic Hemarrtiigeo,ultifacilka,ild -Malignantlymphosa,lymphocytic -Malignantlyaphosa,lymphocyt4c -Not examined,missing -Malignantlysphona,lyaphocytic lymphoma, lyap"-.ocy'6ic -lullcer -Epitheliahlype,plisiis,imple,dif4use.s,ild The fol'Aow;@tri,s.sg,.-ewsere four-dtc be within normal limits: Bra@ir,H,ear"',Lvia'ii'.-.'6es46Lianreg,e Ir!teslineA,orta,Uterus, Ovary, MastiryGland..PitLitary, Trarhei,Thy,oid,Parathyraid,Esophagus.E,ye. --------------------------------------------------------------------------------------------- Animal Nuiber: IR-4577 Sex: Female Group: 1) CONTROL 0 pps Fite: (Week= 99) Found Dead MicroscopicObservatiors: Pituitary R.imearyEland Micrc.s,.op;Osbcservations: Adrenal Kidney Liver Lymph Node (mesenteric) Misairy Gland Pituitary Spleen Uterus -Hemorrhagicmass, 0.6 ce dia. -Multilabulamrass,4.5 x 3.5 1 2 ce, in right ixilla. -Sinusoidilectisii,cortex,moderi+e -Pelvicsinerilizatiorm,ild Nephrosis,tubular,marked -Portaliionanuclecierll infiltrates,ild Portalbileductproliferatione,itd HePitDCyteVicuclation,au'-tifocalo,'lld -No',exifiinedm,issing -Labularhyperplisia -Hemorrhage, marked Necrosis, moderate @Hetosiderasis,mild -Cysticglands,moderate The followingtissueswere 4ound to be withinnormallimits: Brain,SpinalCord, Done Narrow,Heart,Lun;, Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Ovary, 7rachei,Thyroid,Pirathyraid,Esophagus,Pancreas, SalivaryGland, Eye. ---------------------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 Summarized STAR Page: 60 224 SummarizedSingleTabulatedAniniiReport (continued) IndividuilMicroscopicand Microscopicobservations Riker Laboratories,Inc. p FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 ---------------------------------------------------------------------------------------------- Anisil Number: IR-4579 Sex: Femile Group: 11 CONTROL 0 ppt Fite: (Week= 841 Sacrificedin extresis MacroscopicObservations: Pituitary Skin Live, Stomach Kidney Otservations' Ad-e,ial Ac-ta Heart Kidney Liver Lung Lyg;h Node (sesenteric) Pirat,@yro@a,.' Pituitary Skin Spleen Stomach -Raisedmiss,0.5 ce dii. -Raisedthicker..leeds@lonwith scil.on right side. -Slightlypale -Sciewhat reddened -Flu@dfilledcyst in left ki,.,ney. -Sinusoidielctasii,cortex,mild -Mineralizatioonu,ltifocils,ild -Hyacirditis,chronicnonsu;p;;rative,, oultifocal,moderate -NephrDsis,tubular Pelvic mineralization,marked Cyst,corticil,moderate Hyperplisiap,elvicepithelium,diffuse,sild -HepitDCYte VaEUDlition, sultifacal,mild -Vascularmineralizationm,ild -Not exiained,missing -Not examined,not in plane of section -Adenama -Ulcer,@irked Skin lesionfromside. -Nesosiderasis,mild -Ninerilizationm,ucosal,sild The fol'iow4,tnigssueswere foundto be withinnoriillimits: B,ain, SpinilCord, Bone Narrow,SmallIntestine,LargeIntestine,UriniryBladder,Lterus., Ovary, MammaryBlird, Trachea,Thyroid,Esophagus,Pancreas,SiAiviryGland, Eye. --------------------------------------------------------------------------------------------- Animal Number: IR-4580 Sex: Female Group: ( 1) CON'.IRO0Lppe Fate: (Week= 52) Sacrificedin extresis MicroscopicObservations: Pituitary -Enlarged;dirk red miss,IV.!ce dii. MicroscopicObservations: Adrenal Aorta Esophagus Lymph Node (sesenteric) -Sinuscidaelctasia,cortex,tild -Not examine,.'s.i,ss;ng -Not examined,missing -Not exinined,missing P.assiryBlind _salactocele Parathyraid -Not examined,not in plane of section -------------------------------------------------------------------------------------------- Species: Ral, Project Number: 0221r.RO012 Summarized STAR Page: 61 225 SummarizedSingle TabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3" FC-143:Two Year Oral Toxicity-oncogenicitSYtudy in Rits Table: ---------------------------------------------------------------------------------------------- Animal Number: IR-4580 Sex: Fesile Broup: ( 1) CONTROL0 p;a Fate: (Week= 52) Sacri4@iceidn extromis MicroscopicObservations(continued): Pituitary Spleen -Adenoma -Hemos@lderasis,a-.,@lerate The followingtissueswere found to be within normalli@4ts: bri,4n,Spinallord, Bone Parrow,Liver,K@id,-ieHye,art,Lurtg,SluosichS,aill Intest@lle, Large Intestine,Urinary Bladder,Uterus,Ova-y,Trachea,Thyro@d,Pancreas.S,alivaryGlard,Eye. ------------------------------------------------------------------------------------------------- Ar,ini'N,jeber: Sex: Female Group: 1) CON'IROL0 pps @'Ite:fweekz E'J'Sacrificedin extres4s Ma:rosccpicObse,vations: MialaryBlind Liver 5; 1.eer, MicroscopicObservit@lers: Adrenal Liver Lung Mastary Gland Pirathyroid S;"eer -Ulceratedmass,6 x 6 x 3 co behindright shoulder. -Possiblyslightlypile and swollen. -Enlarged -Sinusaidalectasia,cc-tex -PLrtilslonanuclearcell infiltrate,s4&'au' Hepatocytevicudlitior,.oultifocalm,ild Nepato,,ytealteration,basopi@4alic, Hema@opoiesis,extraiedullary,ikild -Vascularmineralizations,ild Pneumonia,interstitialc,hroiic,aL.-Illi4ocil, ild -Adenocircinama -Not examined,not in plane o4 sectior! -Hesato;oiesise,xtrasedullar-yi,ncreased, marked T@.efcllrw'.ntgissueswere iound to be withinnormal limits: B-a4in,Spi.-tiClord, Bone Marrow,Kidney,Heart,Stomach,Small Intestine,Large Intestine, UriniryBladder,Aerti,Uterus,Ovary,Pituitary,Trichea,Thyroid,Esophagus, Lymph Node (sesenteric),Pancreas',SalivaryBlind,Eye. - -------------------------------------------------------------------------------------------- Animal Number: IR-4583 Sex: Fesile Group: ( 1) CONTROL0 ppe Filue:(Week=105) TerminalSacrifice MicroscopicObservations: Eye -Extensivepost bleedinginflammationof right eye. Rimeary Gland -Firenodularmiss,6 x 5 x 3 co, left inguinal. -------------------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 Summarized STAR Page: 62 226 SusearizedSingle TabulatedAnaimalReport (Continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143:Two Year Oral Toxicity-on:L,.geniSctiutdyyinRits Table:2 ---------------------------------------------------------------------------------------- Animal Number: IF-4587, Sex: Female Group: 1) CONTROL 0 PPI Fate: (Week=105) Ter@4nalSa,-r44fice MicroscopicObservat@lon(sContinued): Adrenal Eye Kidney Liver Lur.g Mammary Gland Ovary Parathyrc4Ad Spl,eer. Uterus -Sinusaidaelctasia,cortex,marked -Panophthalsitiusn,ilateralm,arked -Pelvicsinerali:atiosni,ld Chronicprogressivene;hropathy,minimal -Hepitocytevacualat@on,o.u!t@for.a'oli,l-U, Necrosisi,c:il,tild -Alveolariiicroptagessi,ld Perivasculasrononuclearinfiltratea,@ild -Fibroadenoma -Tubularidenoia,unilateral -Not examined,not in planeof sec+.-ion -Wesitapaiesise,xtraoeiulliryi,ncreasea., moderate -Cysticglands,marked The followingt-ssueswerefoundto be withinnormallimits: Brair@L,@pinaC'ord,Boie Marrow,Heart,Stomach,Small Intestine,LargeIntestine, U-inaryBladder,Aar'La,Pil@u@ltarTyr,achea,Thyroid,Esophagus,Lyap@Node (sesenteric), Fa.icreisS,a&ivaryGland. -----------------------------------------------------------------------------------------A.@!iaaNlumber: IR-4'jS4 Sex: Female Group: 1) CONTROL 0 ppe Fate;(Week=105)TerminalSacrifice Mar.roscapiOcbservations: Eye -Slightitrophvwithcornealopacity,right eye. Pituitary Adre,-ia'a -Enlarged -Leftadrenalenlarged, M;AcroscapiOcbservations: Adrenal Eye Heart -SinLso4ldeicltisi'a,cortex -Phthsisbulbi,moderate -Myocirdi'6isc,hronicnonsuppura'6ive., sultifocals,ild Kidney Liver -Chronicprogressivenephropathy,mild -Portalbileductproliferatiosni,ld Nepatocytevacualationa,ul'6ifocasli.l,d Lung -Pneumoniai,nterstitialc,hronic,oultifocal, sild Perivasculasronanucleairnfiltratem,ild Hemorrhagel,ocalareas,sild Pirathyraid -Notexamined,not in planeof section ------------------------------------------------------------------------------------- Species:Rat Project Number: OI&BICROOll@ Summarized STAR Page: 63 227 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicInd MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143:Two Year Oril Toxicity-OncogenicitSytudy in Rats Table: 2 ------------------------------------------------------------------------------------------- Anisil Number: IR-4584 Sex: Fesile Group: ( 1) CONTROL0 ppo Fite: (Week=105)TerminalSacrifice MicroscopicObservations(continued): Pituitary Spleen -Adencia -Neensiderosis,mild The followingtissuesNe-e foundto be withinnormallimits: Brain, S;inal Cord, Bone Mirrow,Stomach,Small Intes*64,nLea.r,ge Intestine,Urinary Bladder, Aorta, Lterus, Ovary, Mammary Gland, Trachei,Thyroid,Esophagus,Lymph Nc)@e(sesen'Leric), Fincreas,SalivaryGland. --------------------------------------------------------------------------------------------- Ari4laalN,uiftbe@:IR-45H6 Sex* Female Group: 1 1) CONTROL 0 ppe Fite: (Week=105) 'Lere@ir,S.aiclrifice Macrosc.@pi:Observations: F4"1,litary Uterus Microscr;picObservall@lors: Adrenal Kidne-,- Liver Lung Ovary Pancreas Parit,hyroid Pi'6uitiry Uterus -Raised dark &ass,0.71ce dia. -Darkarea,O.r.x 0.5 ce, in Iel.-horn near cervix. -Sinusoidalectasia,cortex,vild -Chronicprogressivenephropathy,mild Pelvic mineralizationm,ild -Partilslonanucleacrellinfiltratem,ild Portalbileductproliferations,ild Hepal.-Dcyatleteration,vi,,uolatedm,ild -Perivascularsonanuclearinfiltrate,sin@Amal -Not examined,missing -Acinaratrophy,moderate -Not examined,not in plane of section -Adencea -Cysticglands,marked The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large intestine, UrinaryBladder,Aorta,HisearyGland,Trachea,Thyroid,Esophagus,Lymph Node (sesenteric), SalivaryBlind,Eye. -------------------------------------------------------------------------------------------- Animal Number: IR-4587 Sex: Female Group: ( 1) CONTROL 0 ppe Fite: (Week=105)TerminalSacrifice MicroscopicObservations: Mammary Gland -Smallnodu'Aa@rass, T x 2 ce, axillary;large miss,8 x 8 x 3 ce, threatarea. --------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 64 228 Sumarized SingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3M FC-143:Two Year Oral Toxicity-OncogenicitSYtudy in Rats Table: 2 ------------------------------------------------------------------------------------------------ Animal Number: 'R-4587 Sri: Femile Group: 1 11 CONTROL 0 ppo Fite: (Week=105)TerminalSacrifice MicroscopicObservations(rantinued): Adrenal Heart Kidr-ey Liver P.a2saryBlard Parathyro'id SalivarySland Skin Spleen Uterus -Sinusoidalectasia,cortex,marked -Myocarditis,chronicnonsuppuritive, oulti4ocal,mild -Chronicprogressivenephropathy,mild Pelvic minerilizat4.onm,inimal -Nepitacytevicualation,OUltifDC&',, -Lobularhyperplasia -Not examined,no*,in plane of section -Not examined,missing -Fibroma, subcutaneous -Hemosideresis,sild -Withinnormal limits Fetterthin protocolnumber The +D'IDWingtissueswere found to be vithi.normal limits: Brain,S;,@inCaolrld, Done Mirrow,Lung, Stomach,Smill Intestine,Large Intestine, L'rinarByladder,Aorta,Ovary,Pituitary,Trachea,Thyroid,Esophagus,Lymph Mode (sesenteric), Pancreas,Eye. --------------------------------------------------------------------------------------------Animal Number: IR-4591 Be%: Female Group: 1) CONTROL 0 ppe Fi'Le:(Week=105) TerminalSacrifice MacroscopicObservations' MicroscopicObservations: Adrenal Kidney Liver Lung Lymph Wade (sesenteric) Pancreas Parathyraid Pituitary -ND visiblelesions. -Corticalvacualation,local areas,moderate Sinusoidalectasia,cortex,mirisil -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltrates,ild Nepitacytealteration,vicuol&ateds,ild -Vascularaineralizationw,ild -Not examined,missing -Atinaratrophy,focal,a-,nimal -lot examined,not in planeof section -Adenota The following tissues *ere found to be within normal limits: Brain, SpinalCard, Bone Narrow,Spleen,Heart,Stomach,Small Intestin'e.Large Intestine, Urinary B"adder,Aorta, Uterus, Ovary, Mammary Gland, Trachea,Thyroid,Esophagus, SalivaryGland, Eye. ---------------------------------------------------------------------------------------------- Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 65 229 SumarizeA.Single TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143:Two Year oral Toxicity-OncogenicitSytudy in Rats Table: 2 ------------------------------------------------------------------------------------------- Anisil Number: IR-4592 Sex: Fesile Group: 1) CONTROL 0 ppe Fate: (Week= 08) Found Dead MacroscopicObservations:.. Pituitary MicroscopicObservations: Adrenal Kidney Liver Lu.,.g Lysp,lNiode (sesenteric) HintaryBlind Parathyroid Fituitary Spleen -Enlarged,0.9 x I ca. -Sinusoidalectis;&&,cortex,.moderate -Chronicprogressiveneph,,Dpa',htyi,nical -Hepatacytevicualationo,ultifocal,mild -Vascularminc-ralizatiomni,ld Perivascularsonanuclearinfiltrate,mild -Not examined,missing -Lobularhyperplasia,moderate -Not examined,not in plane of sectior. -Adenama -Hesos@deresis,sild The followingtissues *ere found to be within normal limits: Brain,SpinalCord, Bone Narrow,Heart,Stomach.Beall Intestine,Large Intestine, UrinaryBladder,Aorta, Uterus,Ova,y, Trachea,Thyroid,Esophagus,Pancreas,Salivaryelind., Eye. --------------------------------------------------------------------------------------------- Anisa7 Hisber: IR-4597V Sex: Female Group: ( 1) CONTRO@.0 pps Fite: !,Week=105)TerminalSacrifice Macroscop4LcObservitiors: MicroscopicObservations' Adrei.al 'Liver Lung Parathyraid -Me visiblelesions. -Sint,.scideacltasia,cortex,marked -Hepatocytealteration,vicuo'aateum'i,ld Nepatocy'6ealteration,basophilic,o@i'Ad -Vascularmineralizalionm,i'd -Not e;aa44nedn,ot in"plane of section The followingtissueswere foundto be withinnormal limits: Brain,SpinalCord, Bone Narrow, Spleen,Kidney,Heart, Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,HisearyBlind,Pituitary,Trachea, Thyroid,Esophagus,Lymph NDde (sesenteric),Pancreas,SalivaryBland, Eye. ----------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROD12 Summarized STAR Page: 66 230 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-147@:Two Year Oral Toxicity-OncogenicityStudy in Rats Table: 2 ------------------------------------------------------------------------------------------------ Animal Number: IR-4594 Sex: Femile Group: 1) CONTROL 0 ppil Fate: (Week= 7q) Found Dead MicroscopicObservations: Kid@ey UrinaryBladder Pituitary M@ic,oscop:-O,bservati,,lrs: Adrenal, Aor@-a Kidney Liver Lun; LyiiphNo-.0eisesenteriac) 0va Pa.-,creas Pari%4h-ircidu Stall Inteslu,;sne Sp,ee.Ur@InaryBliadder -Rfghtkidneyappearsslightlyenlarged; filledwithyellowmilkyfluid. -Enlirged,4.5 x 2 co: fillelw.ith large,hard ci!culi. -Hemorrhagicmiss, 0.9 x 0.6 ca -Sinusa4dalectasia,cortex,.no-Ilerate One of pa@r present -Not examined,missing -Pyeloneo@ritisa,cute,bilateral,moderate Hydronephrosis,bilateral,e,cderate Nephrosisltubular,billiteralmlo,derate -Nepitacy'6ei'Lterationv,a@-uoated,m-"Id -Yaspularminerilizatidna,ild -Not examined,missing -Withinnormallimits One of piir present -No,,eximi.-ied1,4@ssing -No' examined,not in plane of section -Adencti -Not examined,missing -Heicsiderosis,moderate -Epitheliihlyperplasiap,apillary,diffuse, @.irked Calculus The followingtissueswerefound to be within normallimits: Brain,SpinilCard, Boie Narrow,Heart,Stomach,Large Intestine,Uterus,Hismary61and, Trichei,Thyroid,Esophagus,SalivaryGland, Eye. ---------------------------------------------------------------------------------------------- Anisil Number: IR-4595 Sex: Female Group: 1 11 CONTROL 0 ppe Fite: (Week=105) TerminalSicrifice MicroscopicObservations: Pituitary Mineiry Gland Pancreas -Hemorrhagicmass, 0.8 ce dia. -Smalllebularmass,',.7x 1.5 x 1.8 ca, left axilli. -Smalllabularmass,I x 0.7 ca, in ,areaof pancreas. MicroscopicObservations: Adrenal -Sinusoidalectisia,cortex,moderate ---- ------------------------------------------- Species:Rit Project Number: 0281CROO12 SLimearizedSTAR Page: 67 231 Suuarized SingleTabulatedAnimalRepcrt (con'6inued) IndividualMacroscopicand MicroscopicObservations Riker Laburi'6orieIsn,c. 3H FC-143: Tvc Year ofa'aTox'.City-OncogeniciSttYudy in Rats Table: 2 ------------------------------------------------------------------------------------------------ Animal Number: IR-4595 Sex: Female Group: 1) CONTROL 0 PPO Fite: (Week=105)TerminalSacrifice M@IcroscapiOcbservations(continued): Kidney Liver ?a;Tary S:an4@ -C@runic progressivenep@.ro;athy,minimal -Portalsono,-iuclceeal-l in.'iltri,te1.,"' Po-lal.'6i!ed;.,cp+rcli4e-at-.,,-,, mep:t::vl= vacu:!E+ei,ii@ild . hipe!-;Ijaas4 f-El,@'a7cinota Partially encaps,,:'Aitwei-l@l'-,ihrwas-*.corf., ca-,,sL,.IeW.ell difierer.-@ate-i -No6' exa@4-,.etn,ot in plane of se-t@or,. Small c@rcuss:ri@.,pealpil'@arylesic7. t@ls5Leswe-e ;ound to be norinalliii@L4Ls: SP,4@iA Pope Pa-roii,Spl,een,Heart.,-.totach,Small Intestine.L,ir,e 'A.rtest'4.ra., Bladde:-,Aorl.-iT,ra:l@ea,ThyrniJ.,Escpha;Lls,Lyjtp'N,odE (tesente"ic).S,a"A@a@v Cli7d, Eye, Ovary. --------------------------------------------------------------------------------------------- Arifa". ,R-4F;L Sex: Female Grou;: 1) CO@N,TR'@0 ppa Fi'le:(We-2k=7B.'Sa:r-.-i6-e4d,1 Ma7-@-.s:op:lOcbse-vat@Dri-z: FI.6,U.4,6ii.ary -Pass, O.B x C.6 CR. P.a!t:arE.iva.-d -Pass,!-.Sx 2 x 1..'-,.t,in le4tax4lli, -Very pale V,4'"w@n e i -B-.14alera!playle and pi'6ted;s'A'Ac-,tly enliar;ed0;.4 ci dia. cyst in rig,6.1@. A-@lren.al -Pale,bilaterally Observations: Ad!-enal -Ce,t;calvacualatio'n,iocil.,moderate Sinuscidale,:tisii,cortex,moderate Medullarycell hype-plasiao,ultifocal,aild Corticaldegeneration,local areas,moderate Aarl@a -Minerali'.9tiDsni,ld Hinerilizatioanlso in mediaof an elastic arteryin sectionof sesenterysubmittedfor sesentericlymph node. Kidney -Chronicprogressivenephropithy,marked Cyst, cortical,moderate Liver -Nepitocytevacualation,diffuse,@irked -------------------------------------------------------------------------------------------- Species:Rat Project Number: 01,BICROO12 Sumiarized STAR Page: 68 2 3 2 SummarizSeidngleTabulateAdnisiRlepor(tcontinued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 ------------------------------------------------------------------------------------------------- Animal Nuebe-: IR-4.196 Sex:Fesile Group: 1) CONTROL 0 ppa Fite:(Week=78)Sacrificeidn extresis lillicrcscOobpsiecrvations(continued): Lung Lymph Node (mesen"er-',:) .4itca@yG'iarld Pi,athyroil, PitL,4itary Sa';iyary61,an@ Ep'@een UrinaryBladder -Viscullir sineralization,mild Alveo'Aaeracrophages,sin,&&' -Not exisived,missing -Fibroidenagi -Not examined,not in planec4 section -Adenami -NoL examined,missing -Heiposiderosism,oderate -Epithe!iahlyperplisias,ist@',dei.ffuse,mild The fc'!-.wirtgissues*erefoundto be withinnormillimits: B-iin,SpinalCord,Bone Marrow..Heart,Stomach,SmallIntestineL,argeIntestine,Uilerus, -Ov-a-r-y-,-Tr-i-c-i-@-ea-T,-h-yr-c-i-d-,E-s-o-Pp, -h-ag-u-s-,P-i-n-:r-e-a-s-,E-y-e-.------------------------------------------------------------- Anisal Num@.-erI:F-4!97 Seg: Female Group: 1) CONTROL 0 ppe Fate: @'keei=IV@) Ter#,'.naSlacrifice Ma:roscapicObservatiors: Adrer,@al Mic,osco;iO:bserva@iois: Adreral @.idney Liver Lun; LymphNode (sesenteric) ova,y Pancreas Parithyroid Spleen Uterus -Rightadrenalenlarged. -Sinusaidaelctasia,cortex,marked Medullarycellhyperplasiaf,ocal,sild -Chronicprogressivenephropithy,minimal Pelvicmineralizatiens,;.Id -Part&]ear@onu@.lceealrl infilt.,at2ei,l4 Portalbileductproliferatioani,ld -Alveolareacraptagesa,ild Per4,vasculamror-o@-lu,.i.nefairltrate,a-l'Id -No diigrasis,inadequatesection -Tubt;laardenota,u.-,ilaateral, -Cyst -Notexamined,not in planeof section -Hemrsiderosis,a44ld -Withinno-mallimits Fewer than protocolnumber The followingtissueswerefoundto be withinnormall,imits: Brain,Sp-.nalCord,Ba-,Peirrow,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryB"i@der,Aorta,harsarySIird,Pituitary,Trachea,Thyr-@idE,sophagus,SalivaryGland, Eye. -------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO"'&' Summarized STAR Page; 69 233 SuleirizedSingleTabulatedAnimalReport (continued) IndividualM,icroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143:Two Year Oril Tc%iCity-UncogenicitSytudy in Rits Table: 2 ---------------------------------------------------------------------------------------------- Animal Number: IR-4598 Sex: Female Brou;: 1) CONTROL 0 ppe Fate: (Week=105) TerminalSacrifice Macroscopi-,Observations: Pituita-Y A-ul-eial M@cresco;@,c Observat@lors: A,.i,er.-a', Brain Heart Kidney Liver urg Ovary Pancreas Firat@yro4@ P.@l4k@uitary terus -.miss'.0.7 ce dii. -Left adrenilgreatlyenlirge1w. -Sinusoidalectisi.ic,ortex,marked -01agoderirog'4iomab,enign -Myocarditis,chronicnonsu;puratilve, sulatifocal,o,@Ild -Chroric progressivenep@ropat@y,sode-il,,e Pelvic a@inerali,"al-l4iioin-,WI Hyperplisia,pelvic ep.@4theliuml,ocallareas, 'Id -Hepal,ocytveicuclati,.,.i, mild Hepil@-ecyitleltfrationb,asoph;llic&,:Id sir;erilizat4osri.l,d Perivisculirsonanuclearinfiltrate,t4@ld -Tu@ular idenoma -Aciraratrophy,moderate -Not examined,not in plane of section -Adencei -Cysticglands,moderate T@,eicilow-',trigssueswere found to be withinnormallimits: Sp@snallord'.Bzni Pirr-@w,Splaee,-S.l,u-ocatShm,all Intestine,Large Intestine,Urinary Bladder, Aorl@a, Trichsa,Thyroid,Esophagus,Lymph Node (sesenter@iclS,alivaryG'Aand,Eye. --------------------------------------------------------------------------------------------- An@,aa!Num5er: IR-4599 Sex: Fesal&e 6,-oup: 1) CO.ITROL0 ppe Fa'Le:(Week= 102) Found Deidu MacroscopicObservations: Mammary E'lard -Subcutaneousmass, 2.5 x 2 x I ce, in perinei!area. Liver Stomach Urinary Bladder -Appeas mottled -Areasof enlongatedulcerat;on. -ThickenedNalls; mass x ! ca. with adhesionsto abdominal*ill. Eye -No tissue taken due to pos,@norteschanges MicroscopicObservations: Adrenal -Sinusaidalectasia,cortex, marked Aorta -malignantlyaphola,histiocytic Esophagus -Malignantlyaphcaa,histiocytic Eye -Not examined,missing ------------------------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 SusaarizedSTAR Pi;e: 70 2 3 4 SummarizedSingleTabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. ZK FE-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 -------------------------------------------------------------------------------------------- Animal Number: JR-4599 Sex: Female Group: 1) CONTROL 0 ppe Fate: (Week= 10.@)Found Dead MicrosccoicObservations(continued): Heart i.direy Large Intestine Li,ier Lu!,ig Lymph Node (sesenteric) Mammary Bland Ovary Pancreas Parathyroid Pituitary Spleen Stomach Thyroid Uri.naryBladder Uterus -4yocarditisc,hronicnonsu;purativt, sultifocals,ild -Malignantlyaphc)oah,istiocyt4c Pelvicaineraii,itiono,ild Hyperplasia,P;l,vicepithelium,local areas, mild Wephrosis,tubular, o@.1d -Malignantlyaphaaa,histiocytic -Malignantlyaphoss,histiocytic Necrosis,local areas,marked -Malignantlymphoma,histiocytic Hemorrhage,oultifecal,sild -Malignantlyaphdoa,histiocy'6ic -Malignantlyaphdia,histiocytic -Malignantlysphona,hist4acytic -Malignantlyapht)sah,istiocytic -Not examined,not in plane of se:'6'iDn -Adenosa -Hesosiderosiss,ild -Necrosis,sucosil,moderate -Nali;nantlymphosa,histiocy'6ic -Miligiantlyan.hosi.h,islu-ior.yl@ic Epithelialhyperplasia,simple,dii4use,tild -Malignant lymphosa,hiSt4&DCytiC The 4o'llovingtissues were found to be within normal limits: Brain, Sp@,rall :crd, Bone Marrow, Small Intestine, Trachea, Salivary Glald. ------------------------------------------------------------------------------------------------- Animal, !P,-460C, Set: Female Group: File: (Weeiz 991 Found Dead 11 CDNTROL 0 ppe Mi?.-rosco;icObservations: MaB&ary Bland -Subcutaneous cystic mass, 4 x 3.5 x I&ce, in -region of throat; subcutaneous oultilabular mass, 5 x 4 x 2 ce, in rig.lf'6 axilla. Liver -Appears mottled Microscopic Observations: Adrenal -Necrosis, unilateral, marked Eye -Nat examined, missing Heart -Myocarditis, chronic nonsuppuritive, oultifo,6&11, oild ------------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 71 235 SusairizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesi,n-,.3" FE-143:Two Year Oral Toxici'Ly-OncogeniciSttyudy in Rats Table: --------------------------------------------------------------------------------------------- A,-@galNumber: IR-4600 Sex: Female Group: 1) CONTROL 0 PPI Fite: iweekz 99) Found Dead P,@cros.,opOibcservations(continued): Kidney Liver Lure Mateary Slan4. Ovary Parath.vro;d p.ituitary sple;n -Chronicprogressivenephropithy,2ild Pelvicmineralizition*,;Ild Nephrosis,tubular,moderate -Portalsononuclearcell infiltrate,moderate Porl@iblile duct proliferations,ild Hepatocytevacuolitidli, SUI'6ifOCal, Bild Kepatacytealteration,eosinophilic,so4,erate Telin;iectisissi,ld -Vascularaineral@.zationa,ild -Adenogi,papillary Lobularhyperplasia 6yst.,unilateral -Not examined,not in plane of sect-.a,, -Adenami -Hesosiderasiss,ild T@,efollowingtissues*ere foundto be withinnorgillimits: Bra,n,SpinalCord,Bone Mirri3o,Stomach,SaillIntestine,Large Intestine,UrinaryBladder, Ao-ta,Uterus,Tra,-,heTih,yroid,Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryGland. --------------------------------------------------------------------------------------------- Ariiia'N,ua@.,erI:F.-4601. Sex: Fesile Group: 1) CONTROL 0 pps Fi'Le:iWee@.=104EITerminal Sacrifice MacroscopicObservations: Eye Pituitary Adrenal Kidney -Cornea appears cloudy. -Raisedmass, ! r.odia. -Rightadrenilenlirged. -Pale and pitted. MicroscopicObservations: Adreia'A -Sinuscidile-.tasiac,ortex,marked Corticaldegenerationd,iffuse,marked Eye Heart -No diagnosis,inadequatesection -Myocarditis,chronicnonsuppurative, oultifocalm,ild Kidney -Chronic progressivenephropal.-h@yi,rked Pelvicsinerallizatiomni,ld Cyst,cortical Liver Lung -Hepatacytealteration,basophilic,sild -Hemorrhage,local areas..moderate Parithyraid -Not eximined,not in planeof section Pituitary -Adenosa --------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 72 236 SummarizedSingleTabulatedAnisilReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3? FC-143:Two Year Oral TDxicity-Or.cogericSittuydyin Rits Tab"e:2 ------------------------------------------------------------------------------------------------- An@,mil Number: IF@-460,'o2 Sex: Female Broup: ( 1) CONTROL 0 PPR Fate: (week=105)Teraina!Sicrifice Microscopic 06uservi46-(icoonnstinued): Splee,i Uterus -Petos;iderosimsi,ld -With4Anormallimits Fewer than protocolnumber The followin;tissuesmerefoundto be withinnormi'l,imits: Brain,Sp:ralCord,Bone Marrow,Stomach,SmallIntestine,LargeIntestine,UrinaryPladder, Aorta,CiVa'Yr,iSLarySlind,Trachea,Thyroid,Esophagus,LymphNode (sesenteric)P,ancreas, SalivaryBliand. ----------------------------------------------------------------------------------------- AniiilNucluerI:R-463." Sex: Female Broup: 1) CONTROL 0 ppe Fill-e(:Week.1=05)TerminalSacrifice MacroscopicObservations: Liver Skii M@crosco@ic Observations. Adrenal, Heart Ki,4ney L i;er Lt:-g Mammary Gland Parithyraid Pit@ditiry Skin Spleen -Circulari@aseldesion.0.6ct dii.,left laterallobe. -Hairlossan foreliabs. -Sinusaidaalctasia,cortex,moderate Corticaldegenerationd,iffUSE,moderi'6e -Myccarditisc,hronicnonsuppurative, sull'ifocasli,.ld -Pe!vicaineralizati.soinl,d -Portalooro-,tu,.cleeI*alrinfiltratea,'ld Partilbileductproliferatiomni,ld Kepitacytealteration,vacueli@.-egdi,ld -Perivasculasronanucleiirnfiltrates,ilid -Bilicto,.ele -Notexamined,not in planeof section -Adenosa -Acinthosisi,ild -Hemoside-osiss,ild The follaamintgissueswerefoundto be withinnormallio;ts: Brain,SpinalCard,Bone Narrow,Stomach,SmallIntistine,LargeIntestine,UrinaryBladder, Aorta,Uterus,Ovary,Trachea,Thyroid,Esophagus,LymphNode isesenteric)P,ancreas, SalivaryBland,Eye. --------------------------------------------------------------------------------------- Species:Ril, Project Number: 0291CROO12 Summarized STAR Page: 71@ 237 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Toxicity-OncogeniciSttyudy in Rits Table: ---------------------------------------------------------------------------------------------- Animal Number: IR-4604 Sex: Female Grou;: 1) CONTROL 0 ppe Fite:(Weekz105)TerminalSacrifice Micros-r,piO.b-servations: Adre.-al, M,.-.roscopiOcbservations: Adrenal Aorta Esophagus Kidney Large Intestine L'iver 0-,iary Parattyroid 10"6-erus -Le4tadrenalenlarged. -Sinusaidilectas@.&c,orte-..m,arked -Not examined,missing -Not examined,missing -Chronicprogressivenen'r,opathy, a@.1d Pelvicmineralizationm,ild -Not examined,missing -Fortilbileductp;oliferatiosni,ld Hepatacytvoacualationo,ultifocalg,ild Hyperplasticnodule -Cyst,L-niliteral -Notexamined,not in planeof section -Withinnormallimits F;werthin protocolnumber The tissueswerefouidtobe withinrormillimits: ErairiS,pina:Cord.Done Marrow,Spleen,Heaft,Lung,Stomach,Small Intestine,UrinaryBladder., MammaryBlind,Pituitary,Trachea,Thyroid,LymphRode inesenteric)P,ancreas,SalivaryBland, E-y-e-.-------------------------------------------------------------------------------------------AnimalNutter:IR-4601, Sex: Female SrDup: 1) CONTROL 0 ppe Fa46e:(Week.=77) Sacrificedin extrea@as MacroscopicObservations: Kidney Lung -Sligh4l'psiytted -Rightapicill.obe consolidateatnd somewhat enlarged;possiblytumor,mass, chron4c pneumonia. MicroscopicObservations: Adrenal -Necrosis,localareas,moderate Nesitopciesise,xtrasedullaroyu,ltifocal, Heart mild -Ayocarditisc,hronicnonsuppurative, oultifocalm,oderate Malignantlyaphosa,lyaphccytic Kidney -Chronicprogressivenephropathy,made-ite Pelvicmineralizationm,inimal Liver -Nepatocytevacublation,sidzonal,moderate Malignantlymphosa,lyaphc)cytic Lung -Vascularmineralizations,ild Malignantlymphoma,lyaphocytic Largecircumscribemdiss with extensive necrosis. ----------------------------------------------------- ---------- ---------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 74 238 SummarizedSingle TabulatedAnimalReport (continued) IndividualMacroscOCicAnd MicroscopicObservations RikerLibi3ratoriesI,nc. 3H FC-143:Two Year Oral TgxicitY-UncogenicitSytudy in Rits Table: ------------------------------------------------------------------------------------------------ Animal Number: IR-4605 Sex: Female Group: 1) COKTRNWL0 ;;1 Fite: (Week= 77) Sacrificeidn extresis MicroscopicObservations(continued): Ovary Fitu@t'6ary Ss:;44nal Cord . lee,, Urip,ary Bladder -Cyst, unilateral -Not examined, not in plane of section -Adenosa -Malicii, local areas, moderate -Hesosiderosis, aild -Epithelial hyperplasia, simple, d;af4use. moderate The follow@ng tissues were found to be within normal limits: Brain, bone Marrow, Stomach, Small Intestine, Large Intestine, Aorta, Uterus, Massiry Bland, Trachei, Thyroid, Esophagus.,Lymph Node (iiesenteric),Pancreas, Salivary Blind, Eye. ------------------------------------------------------------------------------------------------- Anima: Nutber: IR-4606 Sex: Female Fite: (Week= 105) Terminal Sacrifice Group: 1) CONTROL 0 pps Microscopic Observations: Mammary Bland Pituitary Uterus Ricros-,opic Observations: Adre.-ia: HEart Y.idney Liver Lu.-@g Lymph Node (sesenteric) Mammary Blind Ovary Parathyroid Pituitary Uterus -Soiltl mass, 1.4 ce dia., left laterala area. -Enlarged; circular dark lesion, 0.4 ce dii. -Dark fluid filled lesion, 0.5 x 0.6 ce, right horn. -Siruso@idalectisia, cortex, oild ror,6;cildegeneration, biliteraa.,moderate Pheochroso.-ytosa,benign, unilateral -4yn.6-arditisc,hronic nonsuppuritive, oul,,i4ocal"mild -Chronic progressive nep.-hro;at@iys,ild Pelvic sine@"alli.,ati.Dsni,ld -Hepatocyte vacuolitien, oultifocal, mild Nepatocyte altera'Lion,vacualated.,mild -P;Ignent, moderate Scattered small foci of dark brown pigment-laden eacrophages Nit"-,iarlveoli. -Hemorrhage, mild -Adenocarcinomi -Not examined, sissing -Not examined, not in plane of section -Adenoma -Hydrometri, marked The following tissues were found to be within normal limits: Brain, Spinil Card, Done Narrow, Spleen, Stomach, Small Intestine, Large Intestine, ------------------------------------------------------------------------------------------------ Species: Rat Project Number: 028116'ROOI&2 Suasirized STAR Page: 75 239 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 'IN FC-143:Two Year Oral Toxicity-oncogenicitSytudy in Rits Table; 2 ------------------------------------------------------------------------------------------- Animil Number: IF-4606 Sex: Female Group: 1 1) CONTROL 0 ppe Fite: (Week=105) TerminalSacrifice MicroscopicObservations(continued): The followingtissueswere foundto be w,-'thinnormallimits (continued): UrinaryBladder,Aorta,Trachei,Thyroid,Esophagus,Pancreas,SalivaryBlind,Eye. --------------------------------------------------------------------------------------------- Animal Number: IR-4617 Sex:Femile Brcup: 1) CONTROL 0 ppe Fate: ?Week= 4C))Sacrificedin extreris P.acr,is-.r@C.@1s:e,vations: Soft Tissues(neck) Lymph Node L4,ver Spleen Micros,.-,piOcbservations: Adrenal Aorta Bone Marrow Esop'lligus Eye Kidney L-'.Yer LL-ig Lymph Node (aesenteric) P.astaryGland Ovary Pirathyraid SalivaryGland Spleen Stomach Thyroid Uterus -Reddenedgland like structures,possi.blay enlarged lymp@nodes or salivary glands. -Enlargedaxilla.-y@,,epitics,esentericard internaliliac lymph nodes. -Possiblyslightlypale. -Considerablyenlarged. -Malignantlymphosa, lymphocy'6ic -Malignantlyaphoma, lymphocyt;ac -Malignantlyaphosa,lyaphocytic -No diagnosis,inadequatesection -Malignantlyaphosa,lysphocytic -Malignantlyaphosa,lyephdcytic -Malignantlyaphosa,lymphocylic -Malignantlymphosi,lyaphocytic Hemorrhage,local areas, mild Abscess -Hemorrhage, moderate Malignantlyaphoma,lymphocytit Massive enlarg4entof node by mature appearinglymphocytes.All other fiodes examinedmere sisilarilyinvolved. -Malignantlyaphosa,lyaphocytic -Malignantlymphosa,lymphocytic -Notexamined,not in plane of section -Not examined,missing -Malignantlyaphomi, lymphocytic -Hemorrhage, subsucasal,moderate Malignant lymphoma, lyaphocytic -Malignantlymphosa,lyaphocytic -Malignantlymphosa,lyaphocytic The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Heart,Small Intestine,LargeIntestine,UrinaryBladder,Pituitary, -------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 76 240 Suuarized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand 4itroscopicObservations Riker Laboratories,Inc. '.',M Fr-143:Two Year Oral Toxicity-OncLgenicitSYtudy in Rats Tatle:2 ----------------------------------------------------------------------------------------------- Anisal Number: IR-4607 Sex: Female Brou;: ( 1) CONTROI-0 pps Fate: (Week= 40) Sacrificedin extretis Microscop@IOcbservations(continued): The fol"owingtissueswere foundtc be withinnormallimits(continued): Trachei,Pancreas. ---------------------------------------------------------------------------------------------- Animal Number: IF-4609 Sex: Feeile Group: 1) CONTROL 0 p;t Fate: (keekz105'Teraina"Sacrifice Macro5copicObseryi'Lioi5: Pituitary Mammary Gland M41cros:opitObservations: Adre.-al 4eart Kidney Large Intestine L'iyer Lung Mammary Gland Pancreas Parathyraid Pituitary Spleen Thy!-aid Uterus -Raisedmass,I ca dii. -Mass,5 x 4 ce, throa@area;'vcc dia., left axilla. -Sinusaidalectasia,cortex,moderate -Myocarditis,chronicnonsuppuritive, oultifocal,14&ld -Chronicprogressivenephropathy,a'41d Pelvicsintralizationm,oderate -Not examined,missing -Portalsononuclearcellinfiltrates,ild Por46&1bile duct proliferationm,ild Nepatocytevacualation,sultifocal,sild -Pneumoniai,nterstitialc,hronic,oultifocal, sild -Carcinoma Highlycellularvery undiiierentiatetdueor. -Aciniratrophy,moderate -Not examined.n,ot in plane of section -Adenoga -Hemosiderosis,sild -C cell aderoma -kithinnormallimits Fewer than protocol number The followingtissueswere foundto be withinnormal limits: Brain,Spinal Cord, Bone Marro%, Stoma,-h,Small intestine,UrinaryBladder,Aorta,Ovary, Trachea,Esophagus,Lymph Node (sesen'6eric)S,alivaryGland, Eye. --------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281'.RO012 Summarized STAR Page: 77 241 SupearizeeSingleTabulatedAnisalReport (continued) individualMicroscopicand MicroscopicObservations . Rike!'Laboratories,Inc. 3H FC-143:Too Year Cril Toxicity-OncogenicitSYtudy in Rats Table: i^ --------------------------------------------------------------------------------------------- Anisal Nueber: IR-4611 Sex: Fesile Group: 1) CONTROL 0 ppe Fate: (Week=105)TerminalSacrifice Microscc;icObservations: Namoa,y Blind M@,crDs:cpicObservi'6ions: Adrenal Liver Lung ?,aitirBylind Pirathyroid p;,tuita-y Largelabulirmiss.,10 x 7.5 1 5 is. -Sinusaidale.ctisia,corte@.marked Corticaldegeneration,local areas,moderate -Nepatocytveacualitiono,ultifacils,ild Hepatacytealteration,ecsinaphilicm,ild -Hemorrhage,oultifocal,mild Alveolarmacrophages,oul'Lifo,-aol',lld -Fibraidenosi -Not examined,not in plane of section -Adenosi The followingtissueswere foundto be withinnormallisits: Brain,Sp,'nalCard, Bone Narrow, Spleen,Kidney,Heart, Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorti,Uterus,Ovary,Trachea,Thyroid,Esophagus, '6ygp.N'o-d.e isese,,itericP)a,ncreas,SalivaryBlind, Eye. --------------------------------------------------------------------------------------------- An@ial Number: IR-4612 Sex: Female Group: 1 1) CONTROL 0 ppe Fi:e: (keekz105)TerminalSacrifice Ma--ros-opicObservations: Pituitary 4it.miryGland P@icruscopicObservations: Adrenal Eye Liver Lung Mineiry Gland Par,ithyraid Pituitary Uterus -Raised mass, 0.7 co d;aa. -Mass,3 ce di;.,leftaxilla;4 ce dia., rightaxi!la; 7 x 6 x 1,)ca,rightside. -Sinusaidalectisii,cortex,moderate -No diagnosis,inadequatesection -Nepatocytveicuolitiono,ultifecals,ild -Hemorrhage,diffuse,marked Alveolareacrophiges,iild -elli:tdcele Fibroadencea .Fibroadenosa Two tumors present. -Not ekimined,not in planeof section -Adenoaa -Withinnormallimits Fewer than protace' number The followingtissueswere foundto be withinnormal limits: Brain,SpinalCord, Bone Narrow, Spleen,Kidney,Heart,Stomach,Small Intestine, ------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 79 242 SummarizedSingle TabulatedAnimal Report (Ccntinutd) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-1474T:woYear Oral Toxicity-OncogeniciSttyudyin Rits Table: 2 -------------------------------------------------------------------------------------------- Animal Number: IR-4612 Sex: Female Group: ( 1) CONTROL 0 pps Fate: (Week=101@)TerminalSacrifice MicroscopicObservations(continued): The 4olIlDwing tissues were 4oun6 to be within normal fisits (continued): Large In'6-estineU,rinary Bladder, Aorli, Ovary, Trachea, Thyroid, ESOP,agLs, Lymph Node teesenterici, Par:reas, Salivary Bland. -------------------------------------------------------------------------------------------------- A,-,@salNueler: IR-4614,Z Six: Female Grcup: 1 1) CONTROL 0 pps Fite: (keek= 09) Sacriii7.edin ex@6resis Macr2scopi: Obse-vations: Pituitary Maneary Gland Liver Microscopic Observ4it@lons: Adrenal, Esophagus Kidney Large Intestine Liver Macciry Eland Firithyro4id Piti;il,ary Sp'Aeei,. Urinary Bladder Uterus -Somewhat enlarged -mass, 10 x 8 x 5 ce, inguinil ire&; sur4ice ulcerated. -Appears pale -Nesitopciesis, extramedullatry,sild Sinusoida'ae-.tisia,cortex, o@ald Cortical vacuolation, 4ocal, sild -_eNeot exiiined, missing Ivic mineralization,oild Hyperplasia, pelvic epithelium, local areas, sild -Not examined, missing -Nepatocyte vacuolatidr@,periportia, sild Necrosis, oultifacil,ai"d Nesato;o;es-*&se,xtramedullary, mild -HemorrhigE, oultifocal, mild Pneumonia, interstitial,chronic, oultifocil, mild -Lobular hyperplas;ia -Not examined, no'%.in plane of section -Adenota -Hesatopciesis, extramedullary, increased, moderate -Epitheliilhyperplasii, simple, diffuse, mild -Within norealllimits Festerthan protocol number The following tissues were found to be within normal limits: Brain, Spinal Cord, Done Kirrom, Heart, Stomach, Small Intestine, Aorta, Ovary, Trachea, Thyroid, Lymph Node (aesenteric),Pancreas, Salivary Blind, Eye. ------------------------------------------------------------------------------------------------ Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 79 243 SusBar@IzedSingleTabulateAdnimalReport(continued) IndiyidualM&CfcscOFicand MicroscopicObservations Rike-LatoratoriesI,nc. 7M FE-143:Iva Year Ural Toxicity-oncogenicitSYtudy in Rats Table: 2 ---------------------------------------------------------------------------------------------- Animil Number: IR-4614 Sex: Fesile Group: 1) CONTROL 0 ppe Fite: (Week=105)TerminalSacrifice microscopicObservations: Mammary Gland L'terus M@cros,,o;i,O,bservations: Adrenal Kidney Liver Mismary Gland Pancreas Firil,hyro-,d 'ill-uitary S-ir..iCiard Spleen Thyroid Uterus -massin perinealarea;possiblesilk cyst. -Largegelatinouscervicalmiss, '&cIa dia. -Sinuscidilectisia.cortex,moderate -PEIVICilinerlli2&tiOmni,nimal Chronicprogressivenephropathy,mild -Nepitocyl,veacuala",ions,ultifocal,B',Id -Adenecircinosa -Acinaratrophy,mild -Not examined,not in plane 04 section -Adenost -No diagnosis,inadequatesection -Hemosiderosis,mild -Ulti2obrinchitc'y,st -Polyp This was the &ass it cervixnotedit necropsy. The followingtissueswerefound to be within normallimits: Brain,Bone MarroN,Heart,Lung, Stomach,Small Intestine,Large Intestine,UrinaryBladder, Aorta,Ovary,Trachea,Esophagus,Lymph Node (sesenteric),SalivaryGland,Eye. --------------------------------------------------------------------------------------------- Animal Nuater: IR-461'j Sex: Femille Group: t 1) CONTROL 0 ppe Fite: (Neek=105)TerminalSacrifice P,icroscopiOcbservatiorls: -No visiblelesions. Hicros:opicObservations: Adrenal Aorta Kidney Liver -Sinusoidalectasia,cortex,@irked -Not examined,missing -Pelvicsineralizitionm,inimal -Portalb,ile ductproli4erations,ild Hepitocytealteratioiv,icualatedv,ild -Hepatc:ytaelteritionb,asophilics,ild Lung -Pneumonia,interst@stiilc&h.r,onic, e4,ld Alveolarmacrophages,i'ald Hastary 61&nd -sali@'IlDcele Pirithyroid Spleen -Not examined,not in plane of section -Hemosideros-as,milld Uterus -Wit@.;.nnormal Iii-its Fever than protocol&number -------------------------------------------------------------------------------------------- Spfcies:Rit Project Number: 0281CROOII& SuesarizelmSTAR Page: 80 244 Suuarized SingleTabulatedAnimalReport (continued) Indiv@,dualMacroscopicand MicroscopicObservations RikerLaboratoriesa,nc. T4 M FC-141@: Two Year oral Tcxicilly-oncogenicity Study in Rats Table: 2 ---------------------------------------------------------------------------------------------- Animal Number: IR-4615 Sex: Female Group: ( 1) CONTROL 0 PPI Fate: (Week=10'jlTerminalSacrifice MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits: Sp@ana'ls.Drd,Bone Narrow, Heart, Stomach, Small Intestine,Large Intestine, UrinaryBlidder,Ovary,Pituitary,Trachea,Thyroid,Esophagus,Lymph Node (sesen,Ueric;, Pancreas,SalivaryBlind, Eye. ---------------------------------------------------------------------------------------------- Anicia!Mutter: IP.-461@ Sex: Fepale Group: 1 1) IUC!4TRO0L pps Fate: (Week=1051 Tera;nilSacrifice MacroscopicObservations: Microsc,,p4cObservitio-.is. A @ r e ,.11 heart Kidney Liver Lun; Nameary Blind ovary Parathyraid Splaeen -No visiblelesions. -Corticaldegeneration,unilateral,marked -Myocardialfibrosis,focil,sil@' Myocardi4lis,chronic nonsuppura'6-ive, oultifocals,;ild -Chronicprogressivenephropathy,mild Pelvicmineralizationm,inimal -Par'Lislonanuclearcell infiltrate,s@.ld Portalbileductproliferations,ild Repatocytevacuclation,sultifocal,mild HepatDcytealteration,vacualated,s4,ld -Perivascularsononuclearinfiltrate,moderate Vascularmineralizitions,ild Alveolareacrophages,sild -Not examined,missing -Cyst,unilateral -Not examined,not in plane of section -Hescsiderosis,milad The followingtissueswere foundto be withinnormal limits: Brain,Spinal Cord, BoneNarrow,Stomach,Small Intestine,Large Intestine,UrinaryBladder, Aorta,Uterus,Pituitary,Trachea,Thyroid,Esop@agus,Lymph Node (sesenteric),Pancreas, Salivarygland, Eye. --------------------------------------------------------------------------------------------- Species:Rit Projecl@Number: 0281CROO12 Summarized STAR Page: 61 245 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations Riker'laboratoriesI,nc. TIM FC-14?v:Two Year Ora! TaxicitY-OncogenicitSytudy in Rats Table: 2 --------------------------------------------------------------------------------------------- Animal,Number: IR-4617 Sex: Female Group: 1) CONTROL 0 pps Fate: (Week= 710)Sacrificedin extresis Macroscc;i: Obse-vat@lons: ovary Liver MicroscopicObservallions: Adrenal Liver Lung Mistiry Slan,6i Ovary Parat.',Iy,-oid Pituitary -Hemorrhagicmass, 5 ce dia., left ovary. -Pile;leftlaterallobedirkr.ed. -S;Inusoidaelcl@isia,cortex,sild One of pair present -Por'6&1sononuclearcell infil+rate,o@lld Necrosis,diffuse,marked Massivenecrosisof one lobe with compensatoryincreasein sitosesin another lobe. -Vascularmineralizations,ild -Not examined,missing -Leialyoma '@argewell differentiatedneoplisa,mostly necrotic,probablyarisesfrom an oviduct. -Not examined,not in plane of section -Not examined,missing The follaisint;issueswere foundto be withinno-sillkisits: Brain,Spinal6.0rd,Bone Marrow,Spleen,Kidney,Heart, Stomach,Stall Intesline, Large intestine,UrinaryBladder,Aorta,Uterus,Trachea,Thyroid,Esop6.igLs, Lyt@1:N1Dde ive3enteric),Pancreas,SalivaryBlind, Eye. ---------------------------------------------------------------------------------------------- An'lea'Ntuebe@: IF-46'B Sex: Female Group: 1) CONTROL 0 pps Fate: (Week.=9@@)Sa;rificedin extresis MacroscopicObservations: Pituitary Mammary Gland -Raisedmass, 1.1 ce dia. -Largeulceratedmass, 10 1 7 1 9 ca.,right axillaryarea. M-I,-roscapiOcbservations: Adrenal Esophagus Kidney -Sinuscidalectasia,cortex,sild -Not examined,missing -Pelvicmineralizationm,inimal Liver -Portaloonc*iuclecaerll infiltrates,ild Lung -Yasculirmineralizationa,;Ald Alveolar macrophages,mild Perivasculasrononuclearinfiltrate,sild massiry Gland Parathyroid -Not examined,missing -Not examined,not in plane of section Pituitary -Adenami ---------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Susearized STAR Page: 82 2 46 SusearizedSingleTabulatedAnimalReport (continued) Individualmacroscopicand MicroscopicObservations RikerLaboratoriesI,nce IN FC-143:Two Year Oral Toxicity-OncogenicitSYtudy in Rits Table: 2 ---------------------------------------------------------------------------------------------- AnimallNumber: IR-4618 Sex: Female Group: 1) CONTROL 0 ppe Fate: (Week.=93) Sacrificedin extrecis MicroscopicObservations(cont@Anued): Sk-r, Thyroid Urinary Bladder -Fibroma, subcutaneous Largeneoplasmwith extensivecollagen format4lonl,argeportionne-,roti,-D.es,-r"bed as aa%sarylesionbullno aistarytissue presentin section. -Ultimcbranchiiclyst -Epitheliah)yperplasias,imple,diffuse,aild The fol4lovint@4,,ssueswere found to be within normal limits: Brain, Sp;,nalC,c@-.1B,ane Narrow, Spleen, Heart, Stomach,Small Intestine,Large Intestine, Aorti,Ovary,Trachea,Lymph Mode (sesenteric)P,ancreas,SalivaryBlind,Eye, Uterus. ------------------------------------------------------------------------------------------------ Anima'@Number: IR-4619 Sex: Female Group: 1) CONTROL 0 ppe Fate: (Week= 64) Found Dead Racroscc;'cObservations: sple;,^, Liver Pituitary MicroscopicObservations: Adrenal Esophagus Eye Kidne,@ Liver Lung Lymph Node (sesenteric) Himeary Gland Parathyraid Pituitary SalivaryGland Spleen Stomach Urinary Bladder -Slightlyenlarged -Pale v th an irregullisrurfaceon all lobes. -Enlargedwi4,hhemorrhagicfoci. -Necrosis,diffuse,marked Malignantlyaphosi,histidcytic -Not examined,missing -Not examined,missing -Nephfosis,tubular,marked -Portalbileductproliferationa,irked Necrosis.l,ocal areas,acderate Malignantlyaphosi,histiocytic -Yascularmineril@&zat.rns,ild Malignantlyaphoma,histiocytic -Hemorrhage,mild -Galactacele -Not examined,not in plane of section -Adenoza -Sialader,4lt4clhsr,onic,moderate -Malignantlyaphoma,histiocytic Hematopoiesis,extramedullary,increased, moderate -Necrosis,sucasal,mild -Epitheliahlyperplasias,ispli!dgiffuse,sild The followingtissueswere found to be withinnormal limits: Brain,Spinil Card,lone MarroN,Heart,Small Intestine,LargeIntestine,Aorta,Uterus,Ovary, ------------------------------------- -------------------- ------------------ ---------- Species: Rat Project Number: 0261CROO12 Summarized STAR Page: 63 247 SummarizedSingie TabulatedAn,'.iiRielport (continued) IndividualMacroscopicInd MicroscopicObservations RikerLaboratoriesI,nc. '.N FC-143:Two year Dril Toxicity-OncogenicitSytudy in Rits Table: 2 ----------------------------------------------------------------------------------------------- An@mal Number: IR-4619 Sex: Femile Group: ( 1) CONTROL0 ppe Faie: (Week= 64) Found Dead Kic-oscop-iOcbservations(conlu-inued): The follooingt,.ssueswere fi3uidto be withinnormallimits(continued): Trachea.Thyroid,Pir.-.reas. -----------------------------------------------------------------------------------------------Anin,ilNur.@e,:'IR-46:1 Sex' Feer,"e Group: 1) CONTROL 0 ppe Fate: (Week= 99) Sacrificedin extresis Macroscopic Observa@%lons: Pituitary Maer,.irGyland Liver Adrenal Microsco;@icOtservi'6ions: Adrenal c@sop3agus Hei,t Kidney Live- Lung Miati-yBland Parat@.yrai.1 Pitui'l,iry Spleen -Slightlyenlarged -Subcutaneousulceratedmass, 5 x 4 in rightaxilla. -Ap@ears mottled. -S'lightleynlarged. I.r.ce, -Corticalvacuolitionf,ocal'.s;ild Sinusoidilectisia,cortex,marked -Not examined,missing -Myocirditis,chronicnonsuppuritive, oultifeciim,ild -Chronicproqress-lyneephropathy,tild Pelvicmineralizations,ild klep,hros@itsu,bular, moderate -Por'6&s1ononuclearcell inf;.Itritem,inimal Hepatocytevicuolitior.p,eriportal,a@lid -Alveolareacrop@.igess,ild Perivasct:lsaornonu,-Ieairnfiltratea,ild hemorrhage,localareas,sild -FibraidenDia Galactocele -Not eximined,not in planeof section -Adenosi -Nesitapoi.esiesx,tramedullary,increased, aild The followingtissueswere found to be within normallimits: Brain, Sp;nalCard, Bone HirroN,Stomach,Small Intestine,Large Intestine,UrinaryBladder, Aorta,Ute-us,Ovary, Trachea,Thyroid,LymphNode (sesenteric)P,ancreas,SiliviryBlind,Eye. - ------------------------------------------------------------------------------------------- Species: Rat Project Number: 0291CROO12 Summarized STAR Page; 84 248 SummarizedSingle TabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. TM FC-1411:Tvo Year Oril Toxicity-Drl,ogeniciSttyudy in Rats Table: 2 ---------------------------------------------------------------------------------------------- An4mal Number: IR-4622 Sex: Female Group: 1) CONTROL 0 ppo Fate: (Week= 62) Found Dead MacrosccpicCbservatiors: Skin 4aseary G'Aand Kidney @'ituitary "U.-!g Microscopic Observa'.-4&ons: Adrenal Aor@,a Kidney Liver Lung Misiary Gland Parit@,yroid Pituitary Skin -stallcircularlesionon back;slighlh,air loss an left laterals@.de. -Mass,2 co dia.,rightaxillaryarea;1.5 co dia.,leftinguinalarea. -Raisedarei,0.7 ce dia.,an surfaceof right kidney;appearsfluid filled. -Dark red gelatinousmass. -Slightlysettled -Sinuscidilectasia,cor@l-exm,arked -Net exisine@.1m,issing -Chronicprogressivenephro;athy,moderate Pelvicminerillizatiomno,derate Hyperplasia,pelvicepithelium,local areas, mild -Hepatccytevicualation,periportil,moderate -Alveolar eacrophages,mild -salactacele -Notexamined,not in plane of section -Not examined,missing -U:Cer,focal, moderate The fol'&owin';issueswere found to be within nc@-a.1l1i,mits: Bri@.n,Epir-.iC'aard, Bane r!irrDO,Spleen,Heart,Stosacl!S,t,i,ll Intestine,Large Intestine, Ur's.-iaBriyau'der,U'6e,-usO,vary,Trachea, Thyroid..Esophagus,Lymph Made (sesenteric),Pan:reas, Sa'4varyElar.,'E,ye. ------------------------------------------------------------------------------------------------- Aiisal Number: l@-461@ Six: Fesile Group: 1) CONTROL 0 pps Fa:e: (beeka 96)Sac'r"i4iciendextreiis MicroscopicObservations: Eye Mammary Bland -Opacity,righteye. -MultilobLl&r MASS, I'*1 12 x '@@ca, right -axilli. Adrenal -Appear enlarged MicroscopicObservations: Adrenal Esophagus Eye Kidney Liver -Sinusoidalectasia,cortex,marked -Not examined,missing -Cataract,unilateral -Pelvic miner&'A;4,.at4.mcin,imal -Portalsonanucleacrell infiltratem,ild Repitocytealteration,vicualated,sild -------------------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 Summarized STAP Page: 85 249 SussarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rits Table: 2 --------------------------------------------------------------------------------------------- Anisal Nualer: IR-46143 Sex: Female Group: 1) CONTROL 0 ppe Fate: (Wee,'.=96) Sacr@,444ciend extreris Lymoh Node (sesenteri@." Mammary Glar@d P-'atu'atary Thyroid L!terus -Pneumonia, chronic,sultifc-,al, sild Alveol&&,eacrophages,mild Perivascularearonuclearir,4@ltrates,ild -Sinusaida'e@ctasia,moderite -Fibroadenola -Adenogi -Falliculahryperplisiac,ystic,unilateral, mild -Withinnormallimits Fewer than protocol number The followingtissueswere foundto be withinnorsillimits: irain, SpinalCord,Bone Marro*,Spleen,Heart,Stomach,StallIntestine,LargeIntestine, UrinaryBlidder,Aarti,Ovary,Trachea,Parithyroid,Pancreas,SalivaryGland. --------------------------------------------------------------------------------------------- An@s.ilNumber: IR-4624 Sex: Female Group: 1) CONTROL 0 pps Fate: (Week=100)Sacrificedin extresis MacroscopicObservations: Pituitary Mammary Gland -Hemorrhagicmass, 0.6 co dia. -Ulcerated,cysticmass,4 x 4 x :.'.ce, in leftaxilla-throaatrea; oultilabulimaarss,8.5 x 5.5 x '.ca, ir r4lg@.t inguinalarea. Lung -Raisedcircularnodlle,0.6 ce dii.,ir.leit lobe. Hicrostop@icObservations: Adrenal K4Ldr,ey -Sinuscidalectasii,cortex,moderate -Chronicprogressivenephropithy,sin@imal Pelvicsineralizations,ilad Liver -Portalsonanucleacrell infiltratem,ild Portalbileductproli4eratio-sii,ld Nepatocytevacuolatior.o,ultifo,-als,4ald Lung -Pneumonia,intersti'6iaclh,ronic,oultifaci'A, aild Metastaticneoplasm Large aetastasisof samearyadenocarcincei. Mammary Gland -Fibroadenoca Adenacarcinama Ovary -Cyst,unilateral ------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Suesarized STAR Page: 86 250 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations Riker Laboratories,Inc. 3H FC-143: Two Year Oral Toxicity-DncogenicitYStudy in Rits Table: 2 ------------------------------------------------------------------------------------------------ Animal Number: IR-4624 Sex: Female Group: ( 1) CONTROL 0 ppe Fate: tweekz100) Sacrificedin extresis MicroscopicObservations (continued): P,irithyroid Pituitary Spl,een -Not examined,not in plane of section -Adenoei -Heiatopoiesis,extraoedul.laryi,ncreased, moderate The followingtissues were found to be within normal limits: B,ain, Sp;")ilCord.,Pone Marrow, Heart, Storach,Small lnl,estineL,arge Intestine. Urinary Bladder, Aerta, Uterus, Trachea, Thyroid, Esop,@agus,Lymph Node (sesenteric),Pancreas, Salivary Eye. ----------------------------------------------------------------------------------- Animal Nual,er:IF-461.5 Sex: Fesi'le Group: Fate: (W2ekz100) Sacrificedin extresis 1) CONTROL 0 ppe Macroscopi: Observations: Pituitary Mammary G'iand Adrenal Kidrey Hicrus:opicObservations: Adrenal Esophagus Eye Heart Kidney Liver Lung Mistary Gland Pirathyroid Pituitary Spleen -Enlargeddue to raised mass, I.'-is dii. -Cysticmass, 2 cm dia., left axilla. -Both appear enlarged. -So@eNh&46 pitted -Sinusaida'Aectasia, cortex, marked Cortical degeneration,local&areas, sild -Not examined, missing -No diagnosis, inadequate section -Myocarditis,chronic nonsuppurative, sultifocalas.i,ld -Chronic progressive nephropathy, marked -Portalsononuclearcell infiltrate,o;sld Nepatocytevacualation,oultifocal,minimal -Hemorrhage,local ireas, moderate -Fibroadencia -Not examined, not in plane of sec'6ion -Adenosa -Hesaside-asis,mild The followingtissues were found to be within normal limits: Brain, Spinal Card, Bone MarroN, Stomach, Small Intestine,Large Intestine,Urinary Bladder, Aerta, Uterus, Ovary, Trachea, Thyroid, Lymph Made isesenteric),Pancreas, Salivary slard. ---------------------------------------------------------------------------------------------- Species: Rat Project Number: 0261CROO12 Summarized STAR Page: 87 25 1 SummarizedSingle TabulatedAnimal Report (continuedi IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Two Year Cril Toxicity-oncogenicitSytudy in Rats Table: 2 --------------------------------------------------------------------------------------------- Animal Number: IR-4626 Sex: Feeale Group: 1) CONTROL 0 pps Fite: (Week=105)TerainalSacrifice MacrosccpicObservations: Pit,-itary Microsc-ip-,O.t@servatio,,is: Adrenal Ki-Ilney Liver Lung Parathyroid Pituitary Spinal Co-d Spleer, -Raisedmass, 0.9 ce dia. -Pheochrosocytoaib,enign,unilateral -Chronicprogressivenephropathy,soluerate Pelvic minera"ization,moderate -Nepitocytevacualation,oultifocal,s4*',d -Vascularminerilizationt,ild -Not examined,not in plane Of section -Adenama -Not examined,missing -Heeosideras@As,gil&d The followingtissuee.were foundto be withinnormalIiiils: Brain, Bone Marro", Heart,Stoaach, Small 'knles"@InLea.r,ge Intestine,UrinaryBladder,Aorta, Uterus, Ov;r@, ManitaryGland, Trac@,ei,Thyroid,Esophagus,Lycp@,Node (sesenteric),Pancreas, Sa'ivarySland, Eye. ------------------------------------------------------------------------------------------------- Ar-.malku&6,er:!P-46"7 Sex: Fesile Group: 1) CONTROL 0 pps Fate: (ieek=IA@5)Teraina'.Sacrifice Ma:ros:zp;lrO-bservations: Pituitary Mismary Gland -Mass, I x 0.6 ca. -Fire mass, @..5x 4 x T@.5ca, right lateral area;labulirmiss.,7 x 6 x 5 ce, leftaxilia. Hicroscc;44@O.bservations: Adrer!alk -Sinusaidalectasia,cortex,moderate Medullarycell hyperplasii,oultifo.@ala,illd Heart- -Myocarditis,chronic nonsuppur&16,ive, Kidney Liver @UltifDC&I,Gild -Chronic progressivenephropal,hym,oderate -Portalikonenuclecaerllirfil.tate,mild Portalbile duct prolifera4uionm,oderate @iepatDCYtEalteration,baso;h4@l-6,moderate Lung -Vascular mirerali@ziti-.&n4,4'id Alvec',arsa,@ro;..hagemsi,ld Perivascularmanonuclearinfiltrate,sild miasi-Y slan,U -Ade-,iccircinona Neoplasmarisesin severalplaces in a fibroadenoma. Ovary -Tubularidertosau,nilateral Cyst,bilateral ------------------------------------------------------------------------------------------- Species: Rat Project Number: 028"CROOII& Summarized STAR Page: 6! 252 SummarizSeidnglTeabulateAdnimalReport(ECntinued) IndividualMacroscopicand MicroscopicDbservitions RikerLaboratoriesI,nc, 3M FC-141:Two Year OralToxicity-OncogenicitSytudy in Rits Table: ------------------------------------------------------------------------------------------------- Anisal Number: IR-4627 Sex: Female Group: 1) CONTROL 0 pps Fite: (Week=105) TerminalSi@,r4f-.ce M-I:roscopic01,@servit@lo(ncsont;lnued): Pancreas Para",hyroid Ut;rus -isletcell adenomi -No' exam-"nedn,ot in p'laneof section -Ad@enami -Fibroma, subcutaneous -Cysticglands,sild The 4ol"owi-itii;ss-leswere found to be iii@-hinnormal limits: Brain.,c@p:nalCord, Bone Marrow,Spleen,Stomach,Small Intestine,Large Intestine, UrinaryFlidder,Ac-ti,Trachei,Thyroid,Esophagus,LymphNode (sesenteric),SalivaryBlind, Eye. ---------------------------------------------------------------------------------------------Anisal Number: IP-461&8 Sex: Female Group: 1) CONTROL 0 ppe Fite: (Week=105)Term;anaSlacrifice MicroscopicObservations: Pituitary Hassary Bland M41crus-.op4iOcbservi'Lic@ns: Adrenal Esophi;us K'-u'i.ey Liver Lung Mistary S:and Paritb.yr-.id Pitu@tary -Mass, 1.2 cc dia. -Smallnodule,1.5cc dii.,rightaxilli; possiblesilk cyst. -Sinusaidilectasii,cortex,moderate -Not examined, miss4ng -Pelvicmineralizatioim,inimal -Portalbileductproliferationm,ild Repatacytealteration,vicuolited,aild Pepatocytevatualitiono,ultifocal.s,'lld -Vascullatrinerili,,atiosni,ld -Bilictacele Adencea,papillary Small,highlycellularneoplasmlying adjacent to severallargegala,.tocoels. -Not examined,not in plane of section -Adenosa The followingtissueswerefoundto be withinnorail-lisits: Brain,SpinalCard,Bone Narrow,Spleen,Reirt,Stoia.,hS,mall Intestine,Large Intestine, UrinaryBladder,Aarti,Uterus.O,viry,Trichea,Thyroid,LymphMade (sesenteric)F,increis, SalivaryGland, Eye. --------------------------------------------------------------------------------------------- Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 67 253 SummarizedSingleTabulatedAnisilReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboritaries,Inc. T.?. FC-143:Two YearOral Toxicity-OncogenicitSytudy ir Rits Table: ---------------------------------------------------------------------------------------- Anisil Number: IR-4643 Be%: Female Group: 1) CONTROL 0 ppe Fite: (Week= &'V)Sacrificedir extrecis Microsc:picObservit-,ons: Liver Sp iee7i MiapiryBlind P,4,croscc;@OItcservit-.o,,,.s: Acrer,i'4 korti Esophagus Kidney Liver Lung Mineiry61ind Firi'L-hyroid Salivary Spleer, -Very pile -Slightlyenlirged -Largesubcutaneousmiss, 6 x 10 x 2.5 ca, with necroticireis,containing dark brown fluid,ventral abdomen. -Hemil@-opoieseixst,risedulliryc,orticil,mild Sir.L,scideac't4asia,cortex,sild -Not examined,missing -Not examined,missing -Chronicprogressivenephropithy,sinimil, Yacualation,cony.tub. epitheius,so,-erite -hepitocyllv-aecuolition,centrilabular,marked -Vascularminerilizitionm,ild Hemorrhage,oultifocal,mild -Adenocarcinoma Well differentiatedd,uctularpattern,areas of moderatemitc4l@&activity,large areas of necrosis. -Mr.'e6xamined,not in plane of sect@on -No+ exisined,missing -He;atopoiesise,xtraaedullaryi,n-,reased, moderate The following'.issuewsere found to be vith4.normal lin4ts: B.-iin,SpinalCor4g,Bone Hirrom,Heart, Stomach,Small Intesl,i-.Ii.si,rgeIntestine, UrinaryBlid,.erU,terus,Ovary,Pitu@atiryT,rachea,Thyroid,Lyar.1Node (mesenteric),Pancreas, Eye. ---------------------------------------------------------------------------------------------- Anina',NuAter: IR-46'1'4 Sex: Female Group: 1) CONTROI@0 ppe Fal,e:iweek=IIr@lT,ers-'.PiSli,crifice MicroscopicObservations: Pituitary Hineiry Gland -Miss,0.7 ci dii. -Lobularmiss,8 x 6 x 4 co, right lobulirmass,9 x 7 x 3.5 ca,,,left inguinal. MicroscopicObservations: Adrenal -Sinusoidalectisii,cortex,moderate Esophagus -Not exi@44ned,missing Heart -Myocardil@-icsh,ronic nonsuppurative, oull@ifocilm,ild --------------------------------------------------------------------------------------------- Species: Rat Project Number: D'AIBICROO12 Suseari2ed STAR Page: 90 254 Susair@izedSingle TabulatedAn-,oalReport (cl)ntirued@ IndividualMicroscopicIna .4icroscapiOcbservations Rik.erLaboratories,Inc. '.rM FC-147.:TitoYear orii Tox@Aci.ty-OncogEric4SttyudY in Rats Table: --------------------------------------------------------------------------------------------- Ania,alNumber: IR-46@14 Sex: Fesile Group: 1) CONTROL 0 ppe Fate: !Neek=105)TerainalSacrifice Microscopi:Observations(continued@' l@;dney Liver Lun; Missary Slanul Paril,hyro@116 Pitu@'tary Sp,ee@, minimal, -Portals,ono.-iuclecaerll in4itrate, Portalb'.1educt proliferations,ild Hepitocytealteration,vacuolated,sild Hepatacytealteration,basophilic,suderate Hepatocytealteration,eosinophilic,a@ld -Vascularginerilizall-ioci)lr.,d, Perivascularaono-.iu@,liena4riltrite,&@"ld Hemorrhage,oultifocal,sild -Fibroade,-iosa Fibroadenosa Both &asseswere fibroadenesis.Areas of necrosisand cysticareas in tumers. -Not eximined, not in plane D4 section -Adenota -Hematopoiesise,xtrisedullaryi,ncreased, mild Hemosideresis,sil.d The follomiigtissueswere foundto be within noreallinits: Brain,Sp;inalCl;rd, bgne Marrow,Stosach,Seall Intestine,Large Intestine,UrivaryBladl.er, Aorta, Uterus,Ovary, Trachea,Thyroid,Lymph Node lsesentericl,Pancreas,Sal;varySlan4@,Eye. --------------------------------------------------------------------------------------------- Anital Numter: IF.-4615 Sex: Feei'@e Eroup: 11 CONTROL 0 ppt Fate: (Weei= 94) Found Deal Pacr-.stc,iOcbservations: Small Intec-'6ine -Jejunuaappearsinflamsedwith reddishfluid: ileum appearsinflassednear Mammary Sland cecus. -Mass,7 x 7.5 x 2 is, sultilabulaarnd ulcerated,rightinglinil;mass, lightbeigein color,spherici'.2,cL@d-ii., -inleftaxilli. MicroscopicObservations: Adrenal -Sinusaidilectis4lac,ortex,mild Hesatopoiesise,xtrimedullaryc,ortical, moderate Esophagus Eye Kidney -No+ examined, missing -kt exisined,missing -Chronicprogressivenephropathy,sild Pelvicminerali2ations,inimal --------------------------------------------------------------------------------------------- Species: Rat Project Number: 0201CROO12 Summarized STAR Pi;E: 91 255 e.ummarizeSdingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI.nc. 3M FC-143:Two YearOral Toxicity-ontogenicitSytudy in Rats Table: 2 ----------------------------------------------------------------------------------------------- Animal Nue5er: IR-46@15 Sex: Female Group: 1) CONTROL 0 ppe Fate: (Week= 94) Found Deid MicroscopicObservatienstca.-,tinued): L-'.ve.r Lung Mammary Gland Parathy,-oid P-'ttuillary SalivaryBland Spleen Thvro4,d -HePatacytevacuelation,diffuse,mild Hesilopo4aes@ie,xst,rased"'Iary,mild Mitoticactivity,increased,moderate -Vas:ularsineralizltions,ild Metastatic neoplasm -Adenota A,Wlenocarcinosa Extensivenecrosis. -Not examined,not in plane of se:4,.ion -Not examined,missing -Not examined,missing -Nesai6-opoiesiesx,trasedul&laryi,ncreased, marked -Ultist)branchciyislt T6e followingtissueswerefoundto be withinnormallimits: Bri4An,SpinalCord, Bone Karr-ow,Heart,Stomach,Small Intestine,Large Intestine, Ur4lna-y Aar,-a,U'6erus,Ovary, Trachea,'6yaphNode (meserteric),Pancreas. --------------------------------------------------------------------------------------------- Aniail Number: IR-46Z6 Sex: Female Group: 1) CONTROL 0 ppe Fa'Le:Ikeek--10'4"T,erminalSacrifice MacroscopicObservations: Mammary Slind Liver -Massin rightaxillaappears to be mil'@c.yst. -Slightlyraiseddirkmass,0.6 ce d',i.l,eft laterall,obe. MicroscopicObservations: Adrenal -Corticalvacualation,focal,2ild Sinusoidalectisia,cortex,@;Ald Heirt Kidney Large Intestine Liver -Myocardiaflibrosis,oultifocal.s,ild -Chronicprogressivenephropathy,mild -hesa'6,odiisicso,lon -Hepitocytevacualation,ibu!tifc:ala,4,ld Hep-all'acayltteeration,va6,uolitedB,ild Nep,itc:ytaelteration,bisophi!ic,e4,ld Lung -Vas:ulirmineralizatiorsii,ld Alveolar sacrop@.ages,mild Mammary Gland -.Dbularhyperplasia Pancreas -Acinaratrophy,sild Parithyraid -Not examined,not in plane of section Pituitary -Adenoma ---------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 92 256 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopiOcbservations Rike,Laboratories,Inc. 3M FC-141:Two Year Oral Toxicity-oncagenicitSytudy in Rats Table: 2 ---------------------------------------------------------------------------------------------- Animil Number: IR-46')6 Sex: Female Group: 1 1) CONTROL 0 pps Fate: (Week=105)TerminalSacrifice P,icresco;i,m@ut-servationisco.,ttinued): Splee-i -Hemos@iderosis,a@lld The tissueswere found to be withinnormall4a4ts: Briir.,SpinalCcrd, Bone Narrow,c.@osachS,sall Intestine,UrinaryBlidder,Aorta,Uterus, Ovary,Tri,,hea,T,hyrcie,Esophagum.L.v.s;h Nouieitesenterit),SalivaryBlind,Eye. ---------------------------------------------------------------------------------------------- AniaalNutter: IR-4i7,7 Sex: Fesile Group: 1) 'CONTROL0 ppe Fate: tweekz 81.1S1acrificedin extrecis Mar-roscopicObservat4lons: Fitui'Lary Lung Live.M.ac?.Csco;iOctse,-Yatiors: E@,,e Kid.ney L,'.Yer Lung Mismiry Gland pi,6u44ta@y spleen Uterus -Reddenedmass, 1 co dia. -FOC&Iareas of consolidatiori,n.arteriorpart of rightand leftlung. -Possiblypile -Keratitis,acute,marked -Pelvicmineralizations,ild Mineralizationc,ortical,mild Chronic progressivenephropithy,a4&ld -Hepatocytevacuolaticn,peripor'Li'e4c,4.era+e -Pneumonia,acute exudative,loci'&areas, moderate Hem-.rrt.ageB,L'At;&fDCa,, ltil'u' -Salicto:ele -Adennsa -Heoc;;Lderesism,oderate -Cysticglands,moderate The ir,i4lr., tissueswere four.,t.o'be withinnorcallimits: lord, Bcne Narrow,Heart,Stomach,Small Intestine,Large ln*6est;lne, UriAnar,Bfladder,Aorti, nwviry,Trachea,Alrenil,Thyroid,Parathyroid,Esophagus, Lya;"-,Mode Pancreas,SalivaryBland. ------------- ---------------------------------------------------------------------------- Animal Number: IR-4638 Sex: Female Group: ( 1) CONTROL 0 ppe Fate: (Weekx105)TerminalSacrifice MacroscopicObservations: Pituitary -Mass,0.5 ce dia. MicroscopicObservations: Adrenal -Sinusoidaletctasia,cortex,mild Esophagus -Not examined,missing --------------------------------------------------------------------------------------------- Species: Ril, Project Number: 0281CROO12 Summarized STAR Page: 93 257 SuamarizedSingleTabulatedAnimalReport (continued) Individua'Microscopicand Microscopicobservations RikerLaboritariesI,nc. 3?. FC-143:Two Year Or&! Toxicity-oncogenicitSytudy in Rats Table: 2 ------------------------------------------------------------------------------------------------- Animal NuiDer: IR-4638 Sex: Female Broup: 1) COWTROL 0 ppe Fite: (keek=1051TerminalSacrifice Hir.rosco;iOcbservations(continued): Ki,.iney Liver Lung Mammary Gland Parathyroid Pituitary Spleen Uterus -Chronicprogressivenephropathy,sild -Portalbileductproliferations,ild Hepatocytevacuolition,oultifocil,moderate -Vascularsineralizationa,ild -Not examined,missing -Not examined,not in plane o@ section -No diagnosis,inadequatesection -Metasiderasis,mild -Cysticglands,marked The followingtissueswerefound to be withinnormillimits: Brain,SpinalCord, Bone Narrow,Heart,Stomach,Small Intestine,Large Intestine, Urinary Blad4werA,orta,Trachei,Thyroid,Lymph Node (sesenteric),Pancreas,SalivaryBland, Eye, Ovary. --------------------------------------------------------------------------------------------- Animal Number: IR-46IV9 Sex: Female Group: 1) CONTROL 0 ppe Fate: (Week= 56) Sacrificedin extresis MacroscopicObservations: Skin Liver MicroscopicObservations: Kidney Large Intestine Liver Lu,-,; Kan:aryy61,ard S.sp,il,ivaBrlind lee.Uterus -Midsternal subcutaneous mass, e x 8 x 'Ica. -Slightlypile -Pelvicsinerilizationm,ild Chronicprogressivenepirapathy,mild -Regatodiasis,colon -Portaloot%onucleacrell infitrate, s4,ld -Hemorrhage,oultifocal,sild -Fibroadenoma -Not examined,missing -Neeasiderosis,mild -Withinnormallimits Fetterthan pr,.tor.,n,l@r7ter The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Heart,Static@.S,ail! irtest'iteU,rina-, Ac-,6i4 Pituitary,Trachea,Adrenit,Thyroid,Paral.hyr-oi.@, ',:ese-.tE-,-.Oca'n:reas, Eye. -------------------------------------------------------------------------------------------- Species: Rat Project Nuaber: 028'a-@'ROO'll- Suesa,-41-,SeTdAR ;i;e: 94 258 Suamari@.edS@P-"jle 7abulate@ A.-.isaR,e;:,"6 l,il."avidui'l il,t ,i Cbseryltlons Rik.e-Libo-ateies, Inc. ',M F:-14": Year 5ral To@-.@'city-Oncc;eri,14S,ttuYdY -n ka'Ls -------------------------------------------------------------------------------------------------- Nater: IR @@i! Sex: Male Fi'6E:',@E?Vz Terminal Sacrifice BroL;: ci)FC-14: P.a:rzscl:@'IObserva"-'.c,-,s: F; -Ra@sel miss. 0.5 ca dia. pr.-gress;ve a c1.ea.- ce a -.6 a Heoz-rhage,aul'6,ifocam'o4d,erate -Adenot;a ei,d t e.1 adenota me-i fou,@,tl-,te niriiallimits: Boie Pi,rzv;H,eart,Stomach,Sail'AIntestineI,.ar;eIntestine, Aorti,Testis!EpididygiPsr,ostate,ParathyrDidT,rachea,Esop.lagus, L*,.i;4"-low4e Pancreas.S,alivaryBland,Eye. ---------------------------------------------------------------------------------------- Ar,4;p.Naj'ml.,er: Sex:lale Grou;: t 51 FE-1437@00ppig Fai.-e(:Week=106) Tere@Ira'SAacrifice Picrosc:;itClws-eva6tions: Ski-, P tuitary KiA dney Adrenal Testis!Epididysis -Ulceratedmass.'&.8r.mdia.,dorsal. -Hemorrhagiclesion,0.2 cc dia. -Pale -Leftadrenilenlarged,O.t"co dia.miss. -Testestill,bilateral. riicroscopiOcbservations: Adrenal Eye Heart -PIleoch-osocyl6bveinii,gn,un;litera: -Re'6iriaat'r.ophy,diffuse,marked -P@yocarditisc,hronicnonsupp-.,rallive, oult4fe@,als,ild Kidney Liver -Chronic progressivenep@!ropat@@ym,oderate -Portalsononucleacrellin4iltrates,ild Cysto d degenerationi,ocaa,&:Ild Lung Parithyraid Pituitary SalivaryBlind -VaSCLIa,tineralizat-,osni,l@ -Not examined,missing -Adenama -Nct examinej,missing Sk-,n -Keratoicanthotab,ack ----------------------------------------------------------------------------------------- Species:Rat Project NLaber: 0281CROO12 SumBarized STAR Page: 95 259 SummarizedSingleTabulatedAnisal Report (continuedi IndividualMicroscopicand MicroscopicObservations Rike, Laboratories,Inc. '@N FC-143:Two Year Oral 70,.icity-OnccgeniciSttYudy in Rats Table: 2 ---------------------------------------------------------------------------------------------- Anigil Number: !R-:,582 Sex: Mile Brou;: ( 5) FC-141,300 ppe Fite: i.keek1=061 TerminalSacri;ice m:c.-os:c,.@Oi@:.servaliDnsicantinued): ee-. es'@,s,E;,id@,dynis T.I.yroid -Hroosiderosis,sild -Tubuleatrophy.ispersito;enesisb,ili'eral, gild -Not exitined,missing The ti,2sues were found to be within normal limits: Brain, Spinal.Cc-d, B3ne rarrcm,Stcrach,Small Intestine,Large lnl,estineU,rina.,)Blidter, Aorta, Prostate, Trachei, Eso;higLS, Lys@h Mode (sesenteric),Pancreas. -------------------------------------------------------------------------------------------------- A,-.ima!Nut@er: Sex: male Fate: (@eek= 1")6@T,erminal Sacrifice Group: 5) Fr6-14".'%00pf,a r.acros::P-AcG'Wservations: L4Lyer 4drenal i"iver L6,,-!; Te---tis!E;4"."dye's -Pale raised &asses, 14.3ce d@la..r,ight laterallobe;0.6 ce dii.,left laterallobe. -Sinuso44da'e,ctasia, cortex, sodera'L-Chronic progressive nep@@ropaluhym,ield -Nepatacellular carcinoma Megalocytosis,sild Portal Dronuclearcell Cys'uoiddegeneration,focal, mild Repitocytealteriticn,vacuolited,Pild -Vasculargirerilizationg,ild Alivee'samricropha-@es,sild -Leydi;cell aderati,unilateral V.iscu*,amrineral"zition, a4&',.d T,',,e tissues sere found to be within norral limits: Brain, Sp4.r.-Ca@l@-d,gone rirrow, Spleen, Heart, Stomach, Small Intestine, Lar;e ln'6es'.ine, Urinary B:adder'.Aor'la,Prostate, Pituitary, Thyrr,@AdP,arathyraid,Trachea, Esophig;;s, Lyap@,Node (eesenteric),Pancrois, Saliva,y Bland, Eye. ------------------------------------------------------------------------------------------------- A.pisalNumber: IR-3585 Sex: ?.ale Group: FC-14')300 pra Fate: (Weekz 106"-Terminal Sacrifice Macroscopic Observations: Lung -Raised pale les;kan.0..,5 cR dia., left lobe. Microscopic Observations: K@sdney -Chronic progressivenephropathy,sild ---------------------------------------------------------------------------------------------- Species: Rat Project Numoer: 0261CROO12 Summarized STAR Page: 96 260 SummarizedSingle TabulatedAnimalReport (continued) 7Andividual Pacroscapic A-ld Hicroscopi: Observations Riker Laboratories,Inc. @'M FC-147.:Two Year Oral lcxicilly-nntogericitSytudy in Rits Table: 2 ----------------------------------------------------------------------------------------------- Aiia,ilNum@U'er:1;-.'T4c8,c Sex: Mile Group: 5) Flu'-14!,v"Onp;o Fite: (Week--106' Teraina: Sacr@.fice M,*Icr-,lscoOpbiscervations (continue4u": LVer Fancreas -Pzrtaiacnonucleircell infiltrate,mild Cys,@laiddegenera'6ici,sultifocal, mild Malignant lyaphoti,lymphocytic Hepatccyte alteration,basc.ohilic,moderate Nega'locytosis,minimal -Vascularmineralization.mild Fibrosis,pleural, moderate -Acinar atrophy,sild Hyperpl,asiaa,cinar cell, sild Tfiifo"!,Dw,.ntgissuesiserefound '6rb,e within normal limits: Bra@'..Snp,irii Cord, Bone Marrow, Spleen, Heart, Stomach, Small Intestine, Large Intestine, U-ina,y F"iJder, Aor'La,Testis!Epididysis,Prostate,Pituitary,Adrer@al,T,hyroid, Pa-at,@yrcid, Trac,@ea,Esophagus, Lymph kode faesenteric),Salivary Gland.,Eye. ------------------------------------------------------------------------------------------------Animal kugber: IR-1186 Sex: Male Group: 5) FC-143 300 ppe Fate: (Week=106) Terminal Sacrifice Macroscopic Cbservitiois: Liver Test@is!Ep@4d;dvc@s P,ic-oscopi,O.bserva4l-iors: Adre,@.ill Heart K-,dr,e,i Liver Lung Pancreas Salivary 614&-id Test'is/Epididys-as -Possible pale 4oc@Aon one !obe. -Pale &ass, I cc dia. -Cortical,vacuolation., mild Sinusnidalectisia,cortex,mild -Kycrardi.'is,-6trtinincoisuppura*@4,vem,4,,','u -Chronic progressive nephropittiy,moderate -Portilsononjclearcell infiltrate,aild Cystoid degeneration,aultifeeal,moderate ?@egalo.,ytosisi,ild -Vascular &4&nerala@a,-aluiso4nA,ld -Acinir atrophy,moderate -Sialaderitis, chron@ac,moderate -Tubule atrophy, aspereatagenesis,moderate -Mineralizationt,ubular,sild Leydig cell adencea, b@&lateral The following tissues were found to be within normal limits: Spleen, Stosa:h,Seal! Intestine,Large Intestine,Urinary Bladder,Aorta, Frostate,Pitui@6.iry, grair,,Spinal Cor-.1B,one MirroN, Thyroid, Parathyro4Ad,Trachea, Esoptiagus, Lymph kode (sesenteric),Eye. ------------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 97 261 SummarizedSingleTabulatedAnital Report (Continued) IndividualRacroscep-cand MicroscopicObservations RikerLaboratoriesI,nc. 3" FC-143:Too Year Oral Toxicity-oncogenicityStudy in Rats Table: 2 -------------------------------------------------------------------------------------------------- Animal Nuater: IR-1@5e7 Sex: Male Fate: (Week=106) TerminilSacrifice Group: 5) FC-143 300 ppe Macrosco;ic Observations: Eye Mi,,roc.ccpicOtservat@lons: Adrenal E.ie Ki,i-.iey Liver Lur.g Pa@-1-@reas Firathyroid Pituitary Salivary Blind Splee,- -H@popyon, right eye. -SinLsaidalectasia, cortex.air.,sal -Phthsisbulbi, urilateri'am,ariet Lesion characterizedby re,"nal at,@c,Y@. cataract.and cernea! vas.-,.Iarzatio' mni-h collapseof the glcbe. -Cnronic progress;vene;hropathy,si-d -Portal s,.ranucleacrell tild rysto;ddegeneration,e!-@lti4ccatli.ld Hepatacyte ilterition,bisc;.@,@llimci,nimal Me;alo@.ytosis,ikinima' -Vasculi-sinerili,-a'Litm)inl.d Alveolar sicrophiges,sild Perivascularsononucleariniiltril@es,inisala -Hyperplasia,islet cell, moderate -Not examined, not in plane of se.-tio@-, -Cyst,pars distalis -Siilideni'Lisc,hronic, moderate Moderate reactive hyperplisiaof included lymph node. -Hesosiderosis,sild The followingtissues were found to be within normal limits: Brain, Spi.iiir.or4,E.o,ne Karroo, HeirU, Stomach, Small Intestine,Large Intestine, Urinary A-.rti,Testis/Epididysis,Prostate, Thyroid,Trachea,Esophius, Lymph Node (sesenteric). -------------------------------------------------------------------------------------------------- An.ii5alNumber' IP.--Fcoo Sex: ?,ale Brou;: 1 5) FC-14T 100 pDs Fi@e: (ieekz 19) Sicrificeli,n extresis Mi.-roscopicObservations: Thymus -Enlir;ed,1.5 x 1.5 x 0.3 ce, dark red. Liver -Enlarged,brounivellowtottling. Spleen -Markedlyeniarged,e x 2 x I co. Lymph Node (sesenteric) -Enlarged Lymph Node (abdominal) -Hepatic lyapt,nodes enlarged. Small Intestine -Peyer's patches enlarged and reddened. Large Intestine -Peyer's patches enlarged and reddened. Kidney -Slightdilatationof renalpelvis,bilateral. Urinary Bladder -Distendedwith urine. Penis -Swollen ----------------------------------------------------------------------------------------------- Species: Rit Project Number: 0261CROO12 Summarized STAR Page: 98 262 SummarizedSingle TabulatedAnimal Report (continued) lnd4lviduiHlicrosco;icand MicroscopicOtservat,.ons RikerL&bD'ItOriesI.nc. 3H FC-14'vT:wo Year Oral Toxicity-on:ogenicitSytudy in Rats Table: ------------------------------------------------------------------------------------------------ AnisilNumber:IR-')590 Sex: Ma'Al Broup: 5) FC-143 300 ppe Fate: (Weei= 19) Sacrificedin extres@'s Micr-,ksco;Oibcservationsicor."inued': Aorenai Bo,nE Marrow brain EYE Kid,iey Liver Lymp@,Node (ibdot4,r.El) tLymph No,6e(sesenteric*i F;irithy-oic P4,'6uitiry Saill I.,.tes'14Ane Spleei, Thymus Ttivro;@-d 'wi-inarByl'adde- -naligiantlylphoba,lymptocytic -,4i!igninltymphosa, lyap@So,@ytic -malignantlyaphosa, lymphocytic -malignantlyaphati,lyaphocytic -malignin,6lyaphola,lymphocyllic -Malignantlyaphosa, lyspnocytic Pare-ichysailmost cozzletelyrep'iace-b.y1 diffusenceplas'Liccell infiltrate. -4o.,ignantlyaphomi, lyaphaty'L@ac Hemorrhage,local ,areas,moderate -Malignantlymphoti,histiccytic Extensiveneoplisticinvolvementof hepa4i: node. -MalignantlyaphDI,lyapho:y*uic -Not examined,missing -No diagnas'isi,nadequatesectien -Naligrantlyaphola,lymphocytic -Malignantlymphona,lymphocytic -Malignantlyaphosa.h.ist@acytic -Not examined,missing -Malignant lymphosa,lymphocytic Epithel-.ahly;erptisias,imple,difilse,ai,d 'Ihe tissueswere found to be Nittir.n.orsa'Alimits: Heart,Stomach,Large Intestine,Aorta,Testis/Epid;dysisP,r06tate,Trithei,Esophagus, Firr--eisc,allivarS@larid,Spinal Card. ---------------------------------------------------------------------------------------------- Ani%ii N.Limber: Sex: Mile OrDup: 1 51 F.-143 300 pot Falle:(Week= 106'1Tero4lralSacrif-"ce MacrcscapiirO-bservat4lons: -No visiblelesions. M;Icroscop@acObservatio,-,s: Adrenal Esophagus Kidney Liver -Sinusoidalectasia,cortex,mild -ND diagnosis,inadequatesection -Chronicprogressivenephropathy,minimal -For'6aslonanucleicrelliniiitri-.sei,ld Cystaid degeneration,moderate Hepitocytealteration,basophilic,moderate NegalocytOS41s,minimal Lung -Yascu,ira@aneralizations,ild Alvea'Aarsacrophages,mild Hemorrhage,local areas, moderate ---------------------------------------------------------------------------------------------- Species: Ril@ Project Nuam6er:OI&O@l:ROOII, Summarized STAR Page: 99 263 SummarizedSingle TibulitedAnimal Report (comtinued) IndividualMacroscopicand Microscopicobservations RikerLaboratories,Inc. '4M FC-143:Too Year Oril Toxicity-OncogeniciStytudyinRits Tatle:2 ----------------------------------------------------------------------------------------- Animal Number: IR-T.591 Sex: Male Group:( 5) FC-143300 ppa Fate:(keek=106'T,erminalSacrifice MicroscopiOcbservations(continued): Pi+uitary -Adencei The ic"@'13mitriis;sueswere foundto be wl'6-hinno-mi'4limits: Bri,4,n, L',crdE,ope @-irrDW, S',",4een, hea,@t,Stomach, Sai:l Intest@loe,Laroe Ir'lestine. UriniryBladder,Aorta,Testis/E;id@ldysiPsr,ostate.Thyroid,Pi,@i'6'kyr7c-iad:,@-ei, LVL.@iN,n:dE itesenter@Lc@P,ancreas, Sil@lvaryBland, Eye. ------------------------------------------------------------------------------------------ AniaalN,;fter!:P-T.t9l, clex:"'ale Group: ')iFl@-14417400ppg Fa'Le:Weer= 'IC6)TerLi,-aSla,.-rii4ce Mar-cs:opicObse-valions: Live,- Mic@@@s:o;icObser-tat'a.-!s. k..idn.ey Liver lung Parat@..vrc;Ad Thyroid -Raise,p"ale lesion,0.6 ce d@a.,interior ciuditelobe. -Chronicprogressivenephropithym,ild -NegalOCYtDSiS,MiniGil Portalidnanucleicrellini4Altritmei.l,d Cys'@oiddegenerit4lon, Hepatacellulacrarcinoma 6elldifferentiatetdr,ibeculaprattern, moderatea,"t&Liacctivity,vascularinvisior.. -Visculara@IneraliT.atisoirlid, Alveolarsacrophigesa,ild -Notexamined,not in planeof section -C cel'Ladenosa The following'issueswere found 4-cbe w,.thinr..,o-ei1l44&sits: krain,Sp@@ni'l@ord,Bone rarrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, Blidder,Aorta,Tes'6is/EpididysPirso,state.Pituitary,Adrenal.T,richea,Esophagus, Lymph N@,--(iseesen4Leric@P,ancreas,SalivarySlan4.,Eye. ---------------------------------------------------------------------------------------------Animal Nomber: IR-7@594 Sex: Mile Group: ( 5) FE-143300 pps Fite: (Week=106)TerminalSicrif@Lce MacroscopicObservations: Liver -Palefocithroughcut. MicroscopicObservations: Adrenal Heart -Sinusaidaelctisii,cortex.m.oderate -Myocarditisc,hronicnonsu;purative, oulti4ocalm,inimal Kidney -Chron4cprogressivenephropithy,oild -----------------------------------------:------------------------------------------------------- Species:Rat Project Number: 0261CROO12 Summarized STAR Page: 100 264 SummarizedSingle Tabuia',eAdnimal Report (cont4lnued) Individualmi-,roscopiacnd MicroscopicObservations Rik.erLiibcr&tDriesI,nr. 3H FC-143:Too Year Oral Toxicity-OncogenicitSytudy in Rats Tatle: --------------------------------------------------------------------------------------------- Animal Nuaber: IR-71594 Sex: Male Fate: (Week-.1=06) Terminal Sa:rifice Broup: 1 5) FC-141@1,400pot Mi,-resccpiOcbservationsicontinuell": Liver Lt.,7,g Parithyro4,d P;,tuita-Y Testis!Epididysis Thyroid -Nepitacytevacuolition,diffuse,moderate Cysteid degenerat@on, mild Nepatocyte all,eri@ion,vacliolalle-m@old,erate NegilOCYtDS44S,moderate Centrilabulatrellsenlargedwith finely granular,eOSirDPhi'iE,'groun,g.l'ass' appea,ing -,y,'apliss -Pneuson@ia, irluerstitiaclh,ronic,ciul'6-ifoca,, sild Alveolarsacrophiges,moderate -Not examined,not in planeof sectici, -Ader@,-.ma -Visculi- m4,neral,@,-it4igoOnd,E'a+--HyperplasiaL,'cell,sild The fol'ow@17t.i;ssueswere found to be with'Annormal limits: Bri@,i, Cord, BoneMa-rcd,Sp,een,Stosa,-'S,i.a,!l Intestine,Large Intestiie, Ur4lnaryEiiidder,Acr',i,PrNsti',eT,rachea,E.sopi-aguLsy,aph Mode (sesenteric';P,ancreas, Sal@ivary61an4.,Eye. --------------------------------------------------------------------------------------------- Ari:ila,. IR-TV7r, Sex: Mile Eroup: Ei@e: @Weekz 1061 Teraina! Sacrizi:e F"-141 300 pps Ma-.rosco-,-.,ma2ga-v Bland Pitu,,tary MicroscopicObservations: Adrenal ione 4arrom Kidney Liver -Firsmass,., x 2 x 1.5 ce, r4g',a,x4lli. -Hesorrhi;icmiss,0.5 x 0.7 ca. -ginusaidaelctisia,cortex,sild -Not examined, aiss@.ng -Felvi@s.ine,alizitions,ild Pyelonephritis,acute, ei@Ld Hyperplasia,pelvic epithe!Aiuad.i44use.m.ild -Portiliioion-,iccleelalrin4iltratea,ild Portalbileductproliferations,ild Cystoiddegenerationo,ultifacilg,ild Lung -Vascularmineralizations,ild Alveolar aicrophages,@44ld Pituitary SalivaryBland -Adenomi -Siiladenitisi,cute,moderate Mass describedat necrapsy as sameary gland was apparentlythe enlarged,infliesed salivarygland. No samearytissuewas presenton any slide. ------------------------------------------------------------------------------------------ Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 101 265 SuamarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand Microscopicobservations Riker Laboratories, Inc. 3M FC-143: Tot,.Y,ear Oral Toxicity-Oncogenicity Study in Rats Table: 2 -------------------------------------------------------------------------------------------------- Animal Number: IR-3595 Sex* Male Group: ( 5) FC-143 300 ppe Fate: (Yeetz 106) Terminal Sacrifice Micros:opic Observit4lons(continued): Spi.-.a:I.rrd Sp',,eer. -ft' examined, s4@ss@Ang -Hemosiderosis, aiid The 4CilCkir.-C'@,SSLeS were found t@,be within limits: iriin, Heart.,Stomach.,Ssa';lIntes4,-,neL,arge Intestine, Urinary Bladde-, ADrta, rrosta'Le, Thy,-c-il.P,arat@.yroid, Trachea, Erophagus, llympl,M-o!de Eye. -------------------------------------------------------------------------------------------------- An.mal klimier:IR-!5q6 Sex: Male F;@e: (keei.=1-)6)Teraina: Sa,-r44fice Group: 5) FC-14'4300 ppe Ma:roscop@c O@--servilions: Kid.-I.E-Y M;Icrosco;44c Observiticris: Adrer,a' Hear' O,idiney Liver Lung Pituitary Test-is"E;ididya@As -Pale.,enlarged and pitted, bilateral. vi.,uolatior,s.ultifocal, @4,nimal, Medullary cell hyperplasia, fecal, a@lll -Myocardit@as, chronic no-isup;urative, cultifocal,sild -Chronic progressive nephrepathy, earke4. Cyst. cortical, moderate -Portal monanuclear,ell infiltrate,sild Hepatacyte vacuolation, sultifoca!, sild Hepatocyte alteration, vacuolalled,sild Negal-.,-ytosis,mild -Vascular mineralization, mild Hemorrhage, local areas, marked -Adenoma -Polyarter'itis,moderate The following tissues were found to be within r@ormal'Limits: Brain, Spinal Cord, Bone Marrow, Spleen, Stomach, Small Intest'Ane,Large Intestine, Urinary Plidder, Aorta, Prostate, Thyroid, Parithyroid, Trachea, Esophagus, Lyaph Node (seseiteric), Pancreas, Sals"varyEland, Eye. -------------------------------------------------------------------------------------------------- Anita: KLAber: IR-'@597 Sex: Male Fate: ikeekz 106')Terminal Sacrifice Group: ( 5) FC-147 300 ppi Macroscopic Observations: -No visible lesions. Microscopic Obse-vations: Heart -Myocarditis, chronic nonsuppurative, sultifeca", mild ------------------------------------------------------------------------------------------------ Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 102 266 SummarizedSingleTabulatedAtwisalR,eport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FC-143:Two Year Oral Toxicity-oncogenicitSytudy in Rats Table: 2 --------------------------------------------------------------------------------------------- Animal Number: IR-1.597 Sex: Kale Group: ( 5) FC-14,@300 ppe Fate: (Neekz106)TerminalSacrifice MicroscopicObservations(continued): Kidney Liver Lu7.g PancrEaS Prostate -Chronicprogressivenephropathy,sild -Porl'islonanucleacrellinfiltrates,ild Portalbile du&lproliferat@aDns.i,ld Hepatocytealteration,vacualited,sild Me;alocytosis,minimal -Visc-.,Isairneri'Aizatiosni,ld -Acinaratrophy,mild -Prostatitis,acute,suppurative,minimal The follooiintgissueswere foundto be withinnormallimits: i,riir.S,p,;lralCord, Bone Karrow,Spleen,Stomach,Small Intestine,Large Intestine, Urinaryb,adder',Aorta,TestistEpididysisP,ituitary,Adrenal,Thyroid,Parathyroit,Trachea, Esophagus,Lymph Node (sesen'Leric)S,alivarySlaand,Eye. ----------------------------------------------------------------------------------------------An@ksal4.u&ber: IF.-3599 Sex: Male Group: t @'l@FC-14'.@300 ppe Falle'(Weeyc106) TerminalSicrif"ce Mar--roscap@IOcbservations: Kidney HicrDSC3PiC Observations. Ki@.ney Liver Lun; Sa',iyaryGland Spleen -Hydronephrosisr,ight kidney. -Chronicprogressivenephropithy,vild Pelvicsinerali.,atioBni,ld Hyperplasia,pelvicepithelium,oult-'&;ocal, moderate -Portalso-idnuclecaerll iniiltrateo,il&d Portalbileductproliferi'Liosfiil,d Cystaiddegenerationo,ultifocal,sild Regalocytasis,Bild -Vascularaineralizatidnm,ild Pneumonia,interstitialc,hronic,Bultifocal, mild Alveolar Ba-,rophagess,ild Hemorrhage,localareas, moderate -Sialidenitisc,hronic,moderate -Hooosiderosiss,ild The followingtissueswere foundto be withinnormallisits: Brain,SpinalCord, Done Narrow,Heart,Stomach,Small Intestin,e Large Intestine, UrinaryBladder,Aorta, TestistEpididysisP,rostate,Pituitary,Adrenal,Thyroid,Parathyraid, Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,Eye. ------------------------------------------------------------------------------------ Species:Rat Project Number: 0281CROO12 SuB@arized STAR Page: 103 267 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations Riker Laboratories,Inc. 7@M FE-143:Tue Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 -------------------------------------------------------------------------------------------- Ar,isa'N,uater' IR-3600 Sex: Halle group: 5) FC-143 300 ppo Fate: (Neekz106) Ters@snalS,acrifice MacroscopicObservations: Liver Hicros:opicObservations: Acrenal inne harrow Heart i,'diney Liver Lur.,, IIYLP@N'fdf (oesepteric@) F'ituil@'ary Sp-,na',',@Grd S;Ieer,. -Mottled -CorticalVaCUOlitiDn,mild -Not exi4ined,missing -Myocirditis,chronicnonsuppurat,,ve. tultifecals,ild -Chronic p;ogress4lvenep@.ro;att@.a.-"Ibd -Potal tono.-.u.-clelal-infiltrates,i',d Port&!bile dt.,cptrol.iferatiomni,',Id Eystaiddegeneration4,ocil,sild Negilo,.ytosism,oderate -Vas,--a,mairnerali:ations,ild A',IveolaBracroptiges'.sild Hemorrhage,local areas, moderate -Hescrrhage,minimal -Not examined.,missing -Not ezaa;lneu"missing -Heaosiderosiss,ild -Vasculi,mineralizationm,ild The followingtissiesiterefoundto be withinnormallimits: Brain, Sluosa:hS,mall Intestine.L.arge Intestine,UrinaryBladder,Ac-ti,P,-osllalT@hey,reid.. Paratt.-yroiTdr,achea,Esophagus,Pancreas,SalivaryGland, Eye. --------------------------------------------------------------------------------------------- Anita!Nueber: IR-3601 Sex: Pale Fal-Le(:Weei=106) TertinalS,acrifice Group: 14)F'@-14@4300 pps Macroscopic Observations: Live- -Mottled;ye:lowraised lesions,0.7 and 0.9 ze dia.,posteriorcaudatelobes. Lygph Node (nesenteric) Stomach -Enlarged -Enlargedgastricrugae MicroscopicObservations: Adrenal Heart -Corticalvacuolitidno,ulti4ocil,moderate -@M,.,ocarditcihsr,c,-iinconsuppurative, oulti4ocal,minimal Kidney Liver -Chronicprogressivenephropathy,sild -Portalon-tanuclecaerllinfiltrates,ild Cystaiddegeneration,oultifocal,moderate Hepitacytealteration,vacuolited,mild RegalocytDsis,moderate Nepatccytealteration,biSDphiliC,moderate ------------------------------------------------------------------------------------------- Species: Rat Project Number: 01,$ICROO12 Summarized STAR Page: 104 268 SumairizedSingleTabulatedAnimalReport (continued) individualMacroscopicand MicroscopicObservations Riker Laboratories,Inc. 3" FC-141T@o:o Year Oril Toxicity-OncogenicitSytudy in Rats Table: 2 ------------------------------------------------------------------------------------------------ Anisa'4 Number: 'AR-74601 Sex: Male Fite: (Week=106) TerminalSacrifice Group: 5) FC-143 300 ppe Microsc-.,pOibcservations(con'inued): Luig Lympl@-Niode (sesenter@Ic' Pancreas Pitui'@iry Stotach -Vasculaart;Aneralizatisci-lid, Hemorrhage,localareas,Birked -Hemorrhage,aild Hesangiosircoma -Aciniratrophy,moderate -Cyst,parsd;Astilis -Adenocarcinoaa Extens@veinfiltrationint-,s@lbibu-.oasrad muscu,aris.Welldifferentiatehdi,gh mitoticindex. Probablypariel,,ciell or"g"i. Tumorcellsin lyapha4L,"cs. T,@efo*ilow'4tnigssueswere foundto be withinnormal,limits* Brain,SpinilCord, Bone Marrow,Spleen.S,mallIntestine,LargeIntest;lneU,rinaryBladder, Aorta,Te5tis!Ep'Ll-il"-P.-'aysc';a.lSe,,Thyroid,Pa-ithyroid,Trachea,Eseptag,,iSsa,lavarvGlind, E-y-e-. ---------------------------------------------------------------------------------------------A,-!irN,uatlter:IR-v76@A,.) L'a-'.@ Mi.le Group: 14) FC-14@'00 pps F24@-e!:,Week1=06) TerminalS,acrifice Maf--rosco;-OLbcservations: Micros:o-icObservations: Adre,@al Heart Kid.ney Liver l@ung LymphNode lsesenteric) Pancreas Spleen Testis/Epididysis Thyroid -No visiblelesions. -Nodultihryperplasiic,ortex,iocil,sild Medullarycellhyperplisiaf,ocal,mild -Nyocardi'6isc,hronicnonsuppura4L-ive, oultiiocals,ild -Chronicprogressivenephropathys,ild -Portalmononur-lecaerlli.,.4iltraaliul-df, KegalDcytosiss,in-'sal -Visc-alamrinerali:itiors.'.A,ld Alveolarmacrop@.iges,ild -HemorrhagE,sild --Islectell adenaaa -Heacsiderosiss,ild -Vascularmineralizatienc,'@ld -C cell adencea The follomiigtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Stomach,SmallIntestine,Large IntestineU,rinaryBladder, Aorta,Prostate,Pituitary,ParithyroidT,rachei,Esophagus,SalivaryGland,Eye. --- ------------------ ---------------------------------------------------------------- Species:Rat Project Number: 0221CROO12 Summarized STAR Page: 105 2 6 9 ,izvdSingleTabulatedAnimalReport (continued) Individualmacroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3" FC-147@:Two Year Oral Toxicity-OncogericitYStudy in Rats Table: 2 -------------------------------------------------------------------------------------------- Anisal Number: IP-360') Sex: male Brou;: 1 5) FC-143 300 PPE Fate: (Week=106)TerminalSacrifice Macrescapi.,Observit-,on5: Hicros:a;,cObservations,. Ad-en,al K-dney Liver Lung Paral,hyro,d -ft visiblelesiors. -Sinusoidalectasii,cortex,minimal -Chronicprogressivenephropathy,sild -Portalsononucleacrellinfiltrates,4ld Cysto-*Addegeneration,foci], Bild flegalacytosism,inimal Nepitocyte&1'6erationb,asophil4.cm,ild -Vascularsineralizations,ild -Not examined,not in plane of sectio.,, The foll,owivtit.i@ssues were foundto be Nithinnormal limits: Brain,SpinizCord, ScieMarrow,S;Iee,-H,e,art,Stomach,Small Intestine,Large Intestine, Ur@inary Aerta, Test4,s/EpididysiPsr,ostate,Pitu,.taryT,hyroid,Trachea, Eso:.@igus, Lympm@k,o4we(sesenteric),Pancreas, Salivary Bland, Eye. -------------------------------------------------------------------------------------------- Anita' Number: IF-3605 Se-.:Male Orcu;: 5) Fl.'-14'')@00ppi Fite: (Week=106)Tereiia'Siacrifice MacroscopicObservations: Liver Observations: Heart -Pile,eattled -Myocirditisc,hronic nonsuppurallive, i,,d'ri,e Liver -Chronicprogressivenephropathy,mild -Portalsonanuclearcell iniil'6r&4ES,ild Portalbile duct proliferationa,i'4d He;atacytevacuola'6-ioonu,ltifocal,mild Cystaid degeneri'6ion, sild RegalDCYtDSiS, minimal Lung -Vascularsineralizat;iosni,ld Pneumonia,interstitialc,hronic,oultifocal, mild Alveo'areacrophiges,moderate Perivascularsor-anucleiirnfilatratem,oderate SalivaryGland Spleen -Siiladen;iticsh,ronic,moderate -Heikatopo;.esiesx,trasedullary,increased, mild Nesosiderasis,sild Testis/Epididyiiis -Tubuleatrophy,aspereatagenesisu,nilateral, marked Vascularsineralizations,ild ------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 106 2 7 0 SummarizedSingleTabulatedAnisilReport icantinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc, 3H FC-143:Two Year Oral ToxiCity-OncogenicitSYtudy in Rits Table: 2 --------------------------------------------------------------------------------------------- Animal Number: IR-'@605 Sex: Mile Group: ( 5) FC-14'4300 PPR Fite: iweekz106@Termini.Sacrifice MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits: Bra-'r.S,;iiElCord. bone Marrow,Stomach,Sail! Intestine,Large Intestine,UrinaryEladder Aorta, Pr@islate,P;.IuuitaryA,drenal, Thyrai-m@P,ara"LhyraidT,rachei, Esophagus, Lymp" Noze isesenteric),Pancreas,Eye. ---------------------------------------------------------------------------------------------- A-,i4i!Number: IR-")606 Sex: Male Fate: (Week.-1-06)TerminalSacrifice Brou;: 1 5) FE-14@'3@00 ppe Macroscop@A-O,bservations: Mi-.ros,-op@O'brs-ervations: Adrenal Kid,-.ey Liver Lung Pira'.-hyroid Splee!-i -No visiblelesions. -Nodularhyperplasia,cortex,focal,mild -Chronicprogressivenephropathy,minimal Pyelonephrit@lsa,cute, s;ild -Porta'siononuclearcell infiltrate,s@Ild Negalacytosis,minimal -Vascularaintralizations.ild -Not examined, no'.in plane of sec4@-ion -Henosiderasis,mild 't@efollowingtissueswere found to be wi'6hinnormal I;Asits: ira4,n,S;i,-alL'v^rJb,one rarrc@k.H.eart, S16ciach.S,mall Intestine,Large Intestine, UrinaryBladcer.,Aorta,Tes4@;s/'--.p-,,."P,rdcisstiast,e,Pituitary,Thyroid,Trachea,Esophagus, Lyip@ No-Ilienesenter@ac)P.i,nCrEaS,SalivaryGland, Eye. ------------------------------------------------------------------------------------------------- Nit@er: IR-3607 Sex: Male Group: 5) FC-14'o'40(p,p.e Fii-.e(:Week=106) TerminalSatriiice Kicros.,opicObservations: Pituitary -NeBorrhagicmass, I x 0.7 ca. MicroscopicOtservations: Adrenal -Corticalv.acuolation,eul,4,ifocimlo,derate Pheochrosocytcsab,enign,unilateral Kidney -t6lron@Apcrogressivenephrcpathy,sild Pyelonephritis,acute,moderate Hyperplasia,pelvicepithelium,diffuse,milid Live.Lung -Portalsonanucleatrellinfiltrates,ild -Yasculirmineral-azatiosni,ld Alveolarmacrophiges,sild Pancreas -Acinaratrophy,sild Hyperplasii,isletcell, moderate ------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 107 271 SummarizedSingleTabulatedAnimal Report (continued) IndividualMicroscapitand MicrostOPicObservations RikerLaboratoriesI,nc. 3H FC-143:Two YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 ----------------------------------------------------------------------------------------------- ArisilNumber:11-7v&07 Sex: Mile Group: ( 5) FC-143300 pps Fate: (Week=106)TerminalSacrifice MicroscopiOcbservations(continued): Pariti@yrdid Pituitary Prostate SalivarySlan.1 Spleein Thyroid Urir,aryila,.ider -Adenoci -Adenota -Pros+atit@isa,cu,@e,suppurative,marked -Sia!adenitisc,hronic,moderate -Hesosiderasiso,ild -Ultisebranchicaylst -Epillhelihayiperplasiis,ia;le,lo,.aalreas, sild The fgl",Dwirtgissueswerefoundto be withinnortillimits: Brain,SpinalC,ord,Bone Marrow,Heart,Stomach,Small IntestineL,argeIntestine,Aorta, Tes'6-is/EpididycT4rAa5c,hea,Esophagus,Lymph Made isesenteric),Eye. ----------------------------------------------------------------------------------------- A.niaalNusi@ler1:R-.T6"w,o Sex. Male Group: 5) FC-143300 ppm Fate: (Wee'vz106)*IrerminSaa!crifi,-e Pia,-rosc-.Cbs;erpva';6iior@cs: Skin MicroscopicObservations: Adrenal Kidney Liver Lur,g Si.-'n Testis/Epididys@Ls Thyroid -Raisedinflassedles;on,left h-ind4o&16-pad. -Sinusoidaelctasia,cortex,mild Moduli,hyperplasiac,ortex,aLItifocala,-"Id -Chronicprogressivenephropithy,minimal -Fcrtalsononucleacrellinf:iltratsei,ld Partilbiledlctproliferatiosni,ld Cystaiddegenerationf,ocaa,sild Nepatocytealterationv,icualated,mild Megalorytosiss,ild -Vascularsiieri';Azatiosn',Ald Alveolarsacrop@.agesa,ild Perivisculasronanucleairnfiltratem,ild -Padodersatitisu,lcerativeh,indle.,m,arked -Tubuleatrophy,aspersatageres4amso,derate cyst The followingtissueswere foundto be withinnormallimits: Brair.S,pinalCord,BoneHirroN,Spleen,Heart,Stomach,Small IntestineL,argeIntestine., UrinaryBladder,Aorta,Prostate,Pituitary,ParathyraidT,rachea,Esophagus, Lymph Mode (sesenter4&cPla,ncreas,SalivaryGland,Eye. -------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROOld' Summarized STAR Page: 10c 272 SummarizedSingleTabulatedAnimal Report (contiRuld%, IndividualMacroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3H FC-143:Two Year DralToxicity-OncogenicitSytudy in Rits Table: 2 ------------------------------------------------------------------------------------------------ Animal Number: IR-3609 Sex: Male Srcup: 5) FC-147@300 pps Fate: (Week--106)TerminalSacrifice Macroscopic Observat@,o.-is: MicrDECCPiC Otservitions: Liver '6ur.g '6y:.tNpo.d1e (sesenter'lc) Pancreas Parathyro@ld Tes"@ls/Epidid,,ais -We visiblelesions. -Nodularhyperplasia,cortex,fo:al,mild -Chronitprog,essivenephropil,hym,inimal -Portaloanonucleacrell infiltrate&.-.Id Forl,abl@le duct pro'liferi'6isoinl,d Nega,ic6.ytosis,aild -Vascularsinerali.zat'kso'ni,ld Hemorrhage,local areas, moderate -Sinusaidalectasia,aiid -Acinar i'6rophy,moderate Polya-Ileritias,-derate -Nct examined.not in plane o4 section -lueyd4c.egll hy;er2lasia,focal,sild T@e followingtissueswere found tz be withinnormal limits: Bri-.ii, Cor@..B.-,,-Mlierrrw, Spleen, Hear'6-S,tomach, S&ill Intest4aneL,arge Intestine, Urina,y Blad-.ieAro,rti,Prostate.F,;Ituitary,.ThyroiTdr,achea,Esophagus,SalivaryGland..Eye. --------------------------------------------------------------------------------------------- Anioal Nutber: IR-36'@O Se%: Malle Fa'6e:'%Meek=lt@6;TerminiLlSacrif@ce Group: 5) FC-143 300 ppe Ma@.res:opic Obseryi'6@ions: Liver Testis/EpidiAdvais -Few pile foci. -Testes appear somewhat small. MicroscopicObservaticns: Adrer.al @.idr,e@., Liver -Phec:hromocytoaab,enign,unilateral -Ctri3nipcrogressivenephropathy,aild -Portalmanonucleacrellinfiltrates,ild Nepatacytevacuolitioro.u,ltifocils,ild Cystciddegeneration,aul46i4ocals,ild Megalocytosis,minimi'L Lung -Vascularsinerilizationa,ild Pneumonia,interstitia'Ac,hron-aco,ultifocal., . oild Per4lyasculacrondnuclearinfiltrate,mir;Asal Neecrrhage,local areas, moderate Pancreas Testis/Epididymis -Acinaratrophy,sild -Mineralizationt,ubular,c'ld Tubule atrophy,aspe,@sitagenesisb,ilatera'A, marked ------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 'Oq 273 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicaid MicroscopicObservations RikerLaboratories,Inc. 3H FC-143: Two Year Oral ToxicitY-Dncgge,"icitSYtudy in Rats Table: 14 ----------------------------------------------------------------------------------------- An@lsa:NLebe?-: 1R-3610 Sex: Male Group: ( 5) FC-1414300 ppg Fate: (Week= 106) Terminal Sacr4*f;bce MicrDsco;icObservations (continued): Thyroi,@, -C-cell adenota Follic-alahryperplasia,cystic,unilateral, moderate The fc"lcwingti:-sueswere found to be withinnormal limits: Prain.,Sp4lna':4o!-d,Bore Marrow, Spl,eer@H,eart, Stomach, Small Intes,6-@neL,arge Intestine, Ur,,na,-Bv',Ia-@ldAecrr.@la,Prostate, Pituillari,Parathyroid, Trachea, Esophagus, Lyap.@N-o,@le isesen",er4,c)S,alivary Gland, Eye. -- ---------------------------------------------------------------------------------------------- Ariisil,Nuihber: IP,-@@611 Sex: hale Fate: (Week= 106@ Terminal Sacrifice Group: 5) FC-143 300 pps Macroscopit Observations: Liver -Few pale foci; raised pale les4iol,0."7ce dia., in median lobe. Microscop4lcObservations: Adrenal Esophagus Heart Ki,wlney Live- -Sinuscidalectisia,cortex,mild Corticalvicuclat4loni,ocil, B@nimil -Not examined, missing -Myocarditis,chronic nonsLppura'Live, sultifocal,a-.*Id -Chronic progressivenephropathy,sild Pelvic sinerilization,minimal -Portalsononuclearcell infiltrate,sild Hepatocyte-vacualationo,ultifocil, Bild Cystciddegeneration.oultiioca",sild Hepatacytealteration,vicualite",m,ild Negalocytosis, minimal Hyperplastic nodule Cells in cords of singlecell thickness.Many cells vacuolated. Large centralblood filled s;a,.e. Lung -Vascular mi.-ieralizatioen;,ld Hemorrhage, local areas, moderate Pancreas Parathyroid Salivary Gland -Acinaratrophy,sild -Not examined, missing -Sialadenitis,chronic, marked Extensive squalo.-.siestiplasia of dLCt epithelium with some ducts occluded by hyperplistic,setaplasticepithelium. Thyroid -Not examined, missing ------------------------------------------------------------------------------------------------ Species: Rat Project Number: 0291CROO12 Summarized STAR rage: Ito 274 SummarizedSingleTabulatedAiinaAlReport (continued) IndividualMicroscopicand Microscopicobservations Riker LatoratDries,Inc. T@m FC-143:Two Year Oral Toxicity-oncogenicitSytudy in Eats Title: -------------------------------------------------------------------------------------------- Animal Number: IR-3611 Sex: Male Group: ( 51 FC-14,@3)00 pps Fate: (Week=106) TerminalSacrifice MicroscopicObservations(contiiuedi: Trachea -Not examined,missing The followin;tissueswere foundto be withinnormallimits: Brain, Spinal Czrd, Bone Vi@row, Spl.eer,S,tomach.,Small Intestine,Large Intes4L41ne, UrinaryBlauder.,Aorta,Test@4s/Epid@ldyePirso,slkiteP,ituitary,LymphNo4.e(sesenteric),Eye. ---------------------------------------------------------------------------------------------- AniiiiNutter: Sex: Mile Fa'Le:(keei.=991 Found Dead Group: 5) FC-143 300 ppe MacroscopicOtservations: Liver MicroscopicObservations: Kidney Liver Lur.g Pa@,-reas Thyroid -Mul'6ilobulimrass,4.5 x 4 x '@ce in area ci rightlaterallobe,attachedto caudate lobe. -Corticalvacuclation,foci,.s@arita! -Chroriicprogressiveneo,',ropithmya,rked -Portalsonanucleacrell infiltratea,-ild Portaib4.1educt prolli4eri4licmri.l,d Ne,,itocellulicrarcinoma Well differentiatedt,rabecularpattern, largeareasof necrosiswithintumor. -Vascu!irmineralizations,ild Alveolareicrophiges,@irked Media! hypertrophy,arteries,moderate -Hyperplas@,&i,sletcell, moderate -Cyst,colloid,sild The follooir,t;issueswere foundto be withinnortallimits: Bra',n,SpinalCord, Bone Karroo,Sp'Aeei,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBlidder,Aorta,Testis.'Epididys4Pkrso,state,Pituitary,Parathyraid,Trachea,Esophagus, Sal,4&varGv!Aand,Eye, Lymph Node (sesenteric). --------------------------------------------------------------------------------------------Animal Number: IR-74614 Sex: Male Group: ( 5) FC-1&4'3)0(1ppe Fate: (Neekz106) TerminalSacrifice MicroscopicObservations: Testis/Epid-ldymis -Pile massesof varioussizes both '6es4les. MicroscopicObservations: Kidney Liver -Chronicprogressivenephropil,bym,ild -Portalsonanuclaicrellinfiltrates,ild Cystoiddegeneration,4ocal,minisil ------------------------------------------------------------------------------------------- Species: R&4, Project Number: 028!CROO12 Summarized STAR Page: 1141 275 SummarizedSingle TabulatedAnimal Report (Continued' IndividualMacroscopicand MicroscopicObsEfvi'Lions RikerLaboratoriesI,nc. 3H FC-1471T:wo Year Oral Toxicity-OncogeniciSttyudyin Ri'6s Table: 2 --------------------------------------------------------------------------------------------- Animal Number: IR-'@614 Sex: Mile Group: ( @4)FE-141@300 ppe Fal,e:fwee@z!Ot) TeraiiilSacrifice Micro5copicObservations(continued): LLig Prostate Spleeil Testis/Epididytis -Vifsculasriperalizations,ild Alveolareacrophages,sild -Not examined,missing -Hecosiderosis,mild -Tubuleatropny,aspertatogenesisu,n4Alateril, moderate Leydigcell adInD&a,unilateral The iollovingtissueswere found to be withinnortillimits: Pri:n, SpinalCord,Bone HirrDo,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorti,Pituitary,Adrenal,Thyroid,ParathyroidT,rachea,Esophagus, lyaph Node isesenteric)P,ancreas,SalivaryGland,Eye. --------------------------------------------------------------------------------------------- Animal Number: IR-3615 Sex: Mile Group: Fate: (Week=106)TerminalSacrifice 5) FC-143')00ppa MicroscopicObservations: Pituitary Tes'-@'Is/Epididysis Mic!-oscop@aOcbservitilo.,.s: Adrenal Kidney Liver Lung Parithyr@-@ad F@AIU-uitary Sil;avaryS:and Spleen Testis/Epididysis -Hass,0.0 ce dia. -Righttestissmall. -Sinuso'Adaelctasia, cortex, o-'&Id -Chroni@.progressivenephropittv.moderate -Portalmaronucleircell in4iltralues,4'd C6 ystoi.1 degeieratirri, ou!16,.'fccal, aiIJ Negalr,-6ytosimsi,nimal -YgS:L:&rmineralization&,;IJ Alveolarsac-ophages,aild He-.orrhagel,oci'areas,sild -Not examined,not in plane of section -Adencoa -Sialadenitisc,hronic,marked Extensivehyperplasiaand aetiplisiac4 duct e;ithelius. -@.eacsiderosis,o@4,d -Tubuleatrophy,asperaatagenesisu,ni'Aiteral, marked The followingtissuessere found to be withinnormallimits: Briin,SpinilCard,Bone Parrott,Heart,Stomach.S,mallIntestine,LargeIntestine, UrinaryBladder,Aorta,ProstalleT,hyroid,Trachea,Esophagus,Lymph Node (sesenteric), Pincreis,Eye. -------------------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 Summarized STAR Page: 112 2 76 SummarizedSingle TabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. '-M Frw-1474:Two Year DrilToxicity-OncogeniCiSttYudy in Rats Table:2 --------------------------------------------------------------------------------------- Animalkusber:IF-'616 Sex: Halt Fate: (Week= 72) FoundDead Group: 5) FC-143 300 ppe MacroscopicObservations: Fituitary MicroscopicObservations: Kid,iey Liver L,jng Pancreas Pitu@AIU-ary Sil-@varyBlind Spleeii -Enlarged,0.9 co dia. -Chronic progressivenephropathy, einisi*l -Portal lOnDnuclecaerllinfiltratae",-ld Nepatocytveacuclations,ultifocall,inima', Cystaiddegenerationo,ultifacils.i,ld Necrosis,sultifocals,ode-ate -Vascularmineralizations,ild Alveola- macrop@.age's.mild Hemorrhage,diffuse,&irked -Hyperplasiaa,cinarcell,moderate -Adenoaa -Neteximi,,iemdi,ssing -Hetosideras4isg,4ald ThE fcl',ow-.ng ',issueswere found to be within normal limits: Brain, Spiril Cord, Bone Mirrow, Heart, Stagi:h, Saill Intestine, Large Intestine, Urinary P'ladulerA,orta, Test4islEpididytis,Prosl,ate,Adrenal, Thyroid, Parithyraid, Trichea.. Esophagus, Lympt, Node isesEnte-41c), Eye. ------------------------------------------------------------------------------------------------- A,,.-.saNiuti.-er:1,R-71616 Sex: Mile Fi'6e:(Weei.=lOt')Tertiial Sacrifice Broup: 5) FC-141 300 pps Ra@@ros:c,-ic Otservil@io-is: Live- Microscopic Observations: Adrenal Kidney L,,Yer Lung -Appears pile,'pile raised mass, I ca d@ba., caudite lobe. -Cortical vicuolation.,oulti4ocal, milld Sinusoidal ectasia, cortex, mild -Chronic progressive nephropithy, ikild -Portal sonanuclearcall infiltrate,iild Kepatacyte vacuolation, sul'6i+ocal,minimal Necrosis,foci!, linisil -Megilocyl6asis,minimal Nepatocellulir carcipora Trabeculkarpattern, many 'Lutorcel:s vacuolited, moderate mitotic activity. -Vascular mineralization, sild Alvec'&ar macrophages, iild The fOlIDN@ng tissues we@e found to be within norea! limits: brain, Spin&',Cord, Done Karroo, Spleen, Heart, Stomach, Small Intestine, Large Intestine, ---------------------------------------------------------------------------------------------- Species: Rat Project Nusber: 0281CROO12 Summarized STAR Page: It,: 277 SummarizedSingle TabulatedAnimal Report (Ccntinutd) IndividualMacroscopicand MicroscopicObservations RikerLatoritoriesI,nc. 3H FC-143:Two Year Oral 7axicity-oncogenicitSytudy in Rats Table, -------------------------------------------------------------------------------------------- Anisilkugber:IR-3618 sex: Mile Group: ( 5) FC-143300 ppe Fite: (Neekz106)Tere@InaS!acrifice MicroscopicObservitions(continued): The fcllowingtissueswere 4oun.d-tboe withinnormallimits (continued): UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Pituitary,Thyroid,Pirathyroid,Trachea, Esophagus,Lymph Node (nesenteric),Pan-.reisS,alivaryBlind,Eye. ---------------------------------------------------------------------------------------------- Animal huster: IR-1@619 Sex: Male Group: i '@@)FC-14'@?300 pps Fite: (Week=106.1TerminalSitrifice MiCrOSLGPiC Observations: Liver Kidney Urinary Bladder Mi,.roscopc Otserqations: Adrenal Kidney l,iver Lung Salivaryfilland t,lrinarByladder -Raised lesions, 2 x 1.5 ca, sed@lir',Ac@-es. -Pydronephrosisl,e4t kidney. -D-*Istendeidnte i'Ldomen.i.illew4w@,thdark colored flu;ad. -Sinusaida.e'c'6as4aac,ortex, mild Nodularhyperplasia,cortex,facil, a.-derate -Chronicprogressivenephropithy,sinitil Hydronephrosisb,ilateral,m,ild -Portilsonanucleacrell infiltratem.ild rys'Laiddegenerationo,ultifecil,sild Regalacytosis,gild Wepitocellularcarcinoma Poorlydif4erentiite4aud,enoidand tribeculir patterns,moderatesita'6iicctivity. -Vascularsineral;zationm.i,ld Neeorrhige,local areas, moderate -Not examined,missing -Epitheliilhyperplisia,simple,d4affusea,il-wi Hei3rrhage,focil,ainiriil, The fe'lltooit;ilsnsgueswere found to be withinnormal limits: Brain, Sp@ini! Bone Mirrov,Spleer..H,eart,Stomach,Small Intestine,Large Intestine, Aorta, Tes'6is/Epididyo;Psr,ostalue,P4,tt:itirTyh,yroid,Parathyraid,Trachea,Esophagus, Lyap" Node (sesenter;ac)P,ancreas,Eye. --------------------------------------------------------------------------------------------- Animil Number: IR-IV621 Sex: 4ale Group: ( 5)-FE-143300 ppe Fite: (Neek=106)TerminilSacrifice MicroscopicObservations: -We visiblelesions. MicroscopicObservations: Kidney -Chronicprogressivenephropithy,sinisil ------------------------ ----------------- -------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 114 2 7 8 SummarizedSingle TabullitedAnimal Re;Drl,(cont4.nued) IndividualMacrrSCDPICand MicroscOP".tOl.servitions Piker Laboratoriesi,r:- 3p, FC-14":Too Year Oral Toxici@y-oncogen'citSYtudy in Rats Table: 2 --------------------------------------------------------------------------------------------- Anizil Number: !R-.r6,?l Sex: Male Group: 5) FC-14'@300 pps Fate: (WeEkz10't)TerminalSacrifice F.@Icros-.opC-l"@c-servation(scor.',,inued): ver Lung Parathyro@ld Salivary61'and Spleen -PortalsononucleacreAll infiltratem,ild Cys'uoidegeneration,oulti4ocal,iild Negalocyt@-s@Ls,silid -Vas-,ulairriineralai-,a'L-mi4o,nl,d -Not examined, not in pline of sec'6ior.. -Sialadeni'6isc,hronic,moderate -Hemosiderasis,mild The fol,lom4l,'-@giss@eswere found tc be within normal limits: Brain,Spinil:ord,Bone Marrow,Heart,Stomach,Seal',Intestile,Large Intestine, Uri,-iarB,l.'.adwlerA,orli, Tes'6is/Ep;td;adyPmrioss,tate,Pituitary,Adre.-,&'T.h,yroid, Trachea, Esophagus,Lymph Node (sesenteric),Pancreas, Eye. -----------------------T------------------------------------------------------------------------Anioil Niabe-: IR-1@6^i3 Sex: Male Group: 5) FC-141@'AO ppe Fa'L'e(:Week= 106')Terminal Sacr@.fice MacroscopicObseryi'6ions: M;Icrosco;4cObservations: Adrenal Kidi,,ey Liver Lung Lymph Node (sesenteric) Pituitary Prostate SalivaryGland Testis/Epididysii -No visiblelesions. -Cortical vacuollation,4ecal, mild Sinuscidalectasia,cortex,moderate -C6hrori.pprogressive nephropatIf@,ys,ild -Portalmc,-,cruclecaerll infil,tratem,ild Nepatocytevicualation,mild Necrosis,iiult;afocaoli,ltd Negalacytos;bs,minimal -Vascullasrineril;bzatiosni,ld Pneumonia,interstitialc,hronic,aul+.ifo,-al, mild Alveolar macrophiges,mild -Hemorrhage,mild -Not examined,missing -Prostatitis,acute,suppurative,moderate -Sialaden@.t;.csh,ronic,eirked . Visculirmineri'44,zati2o'il,ld The followingtissueswere foundto be withinnormal limits: Brain, Spin&14Cord, Bone HirroN,Spleen,Heart,Stogac@lS,mall Intestine,Large Intestine, UrinaryB'adder,Aorta,Thyroid,Pa,athyraid,Trachea,Esophagus,Eye, Pancreas. --------------------------------------------------------------------------------------------- Species: Rat Project Number: 0201CROO12 Summarized STAP Page: 115 2 7 9 7-' Summarized SingleTabulatedAnimalReport (continued) individualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M Two Year Oril ToxiCity-DncogenicitSytudy in Rats Table: 2 ---------------------------------------------------------- -- -------------------------Animil Nuater: 1R-3624 Sex: Male Broup: 5) FC-143 300 pps Fite: (Week.=90) Sacrificedin extresis Mi:roscopi,O,bservations: Pitu,',tary Liver Kidney Testis"Ep@4d@,d@mis M@IcroscepicObservations: Adrenal K-I'dney Liver Lung Pituitary ProstitE Splee,-. Test@is/Ep;ldidysis -Hemorrhagicmass, I 1 0.5 ca. -Possiblypile -Slightlyenlargedand pitted. -Both testes appear susew@-lislilall. -Corticalvacualation,su'4tifacals.'.l,d Medullarycell hyperplasia, Mil'@' -Chronicprogressivenephropithy,moderate -Portalsononucleacrell infiltrates,ild Nepato,.ytveicualition,periportal,moderate -Vascular mineraliZitiDn, mi'&d Pneumonia,interstitialc,hronic,oult4liocal, mi'Ad Alveolareacrophages,sultifocal,sild -Adenama -Prostatitisi,cute, suppurative,marked -Hosesiderasis,milad -Tubuleatrophy,asperaatogenesisb,ilateral, marked The follow'4ntgissueswere found to be withinnormallimits: Bri@in,SpinalCard, Done Narrow, Heart, Stomach,Small Intestine,Large Intestine., Ur4naryBladder,Aorti,Thyroid,Parathyroid,Trachea,Esophagus,'6yaphNode tiesenlieric), Pancreas,SalivaryGland, Eye. ---------------------------------------------------------------------------------------------- Ar.inalNumber: IP.-7@625 Sex' Mi'Ae Broup: 5) FC-14.1'400pps File: (Week= 4'7)Sacrificedin extre2is MicroscopicObservations: Soft T,*.ssue(sneck) -LargeBultinodulimrass.,9 x 8 x 6 ca.,in left neck and throatregion.Possibly of samairyglandor salivaryg?andorigin. Mass containedseveral cystic areas that were filled with dark fluid. Splee,i MicroscopicObservations: Liver -Possiblyslightlyenlarged. -Portal @Dnonuclear cell infilatri'6em,ild Necrosis,focal,sild Regalacyl6asis, minimal Luig -Metastaluicneoplasm Throsbus Largethrombuscontainingtutor cells from salivaryglandtutor. Multiplesmall metistastsof salivarytumorthroughoutlung. ------------- ------------------------------------------------------------- -- ------- Species: Rat Project Number: 02814,CROO12 Summarized STAR Page: 116 2 8 0 SummarizSeidngleTabullitAendimalReporttcdntinued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FE-143:Two YearOral Toxicity-DncogenicitSytudy in Rits Table: 2 --------------------------------------------------------------------------------------------- Ar,44paN,urber: IR-36.'S Se%: Male Group: 1 5) FC-143300 ppe F ate: (Week= 1&7)Sacrificedin extresis MicroscopicOl.servation(scontinued): Salivary 61&,nd Spleen - -C-arcinali Highlycellular.aniplastictumor.A;oearsto have arisenin parotidglindduct. Seallrit of salivarygland tissuearoundmass. -Hesal.opoiesise,xtramedullary,increased, soderate The followingtissueswere fourd to be with4lnc)roil Brain,SpinilCord, Bone Marrow,K4dney,Heart,Stoaazh,Small Intestine,Large Intestine, lwl!-inaFrlyadder,Aorta, Test'is/EpididygiPsr,ostate,Pi'Lu@itirAyd,renil,Tthyroid,Parathyroi,.', Trachea.,Esophagus,Ly2ph Node 'oesenteric),Pancreas, Eye. --------------------------------------------------------------------------------------------- Anilal NLeber: Sex: Male Group: Fa+e: ikee@= 10'.1T)ertina'aSacr-ifice 5) FE-14@@300 ppe Ma:-n.sr.op@0l1..,,servatiors: ,4@a-'roscop4lc Adrenal @,'idr.ey Liver Lung Parill,hyroid Spleen -No visiblelesions. -Corticalvacualat4sonf,oci!, moderate -Chronicprogressivenephropathy,moderate -Partils,ononucleacrellirfil.tratmei,ld Fortilbile duct proliferationo,@,ld Cystoiddegenera,6iDno,ultifocil,mild Negilocytosis,minima'L -Yascular minera'Aiza4liomno,derate Alveolareacrophiges,sild Hetarrhage,local ireis,moderate examined,not in plane of section -Hemosiderosis,sild The following 4-.issuewsere foundto be withinnormallimits: Brain, Spi,-iiClard,Ba-,tMearrow, Heart, Stomach,Small InL-estineL,arge Intestine, UrinaryBlidde-,Aorta,Testis/EpididyiiiPsr,ostate,Pituitary,Thyroid,Trachea.E,sophagus, Lymph Made (sesenteric)P,ancreas,SalivaryGland,Eye. --------------------------------------------------------------------------------------------- Species: Rat Project NuaLler.0281CROO12 Summarized STAR Page: 11,7 2 8 1 Summarized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3h FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 --------------------------------------------------------------------------------------------- Animal Number: IR-1@629 Sex: Male Group: Fate: ikeeka106)TerminalSacrifice 51 Fr@-1411',.KOOppe MacroscopicObservations: P.@Icroscop-O,b,servations: heart Kidney Liver Luig Salivary Elli,-.d Thyroid -Ne visiblelesions. -Myocard;"6isc,hronic nonsuppurative., oultifocals,ild -Chronic progressivenephropi'6hy,a@il-y' -Portalsonaru,.Ieacrell ini@all,ratsEi,ld negalocytosis,mild -Vasculareireralizationa,4,ld Alveolarmacrophiges,mild Hemorrhage, Ir,@,aa:reas'.moderate -Sialadenitis,chronic,fiarke-WI -Ultimobrinchiaclyst The followingtissueswere foundto be withinnormalIiitits: Brairi,Spi,)ilCord, Bone Marrow,Spleen,Stomach,Small Intestine,Large Intestine, Llr;ana,B-lyiidderA,orti, Tesl,is,'EpididyiP@rso,si6-atPei,tuitary,Adrenal,Parathyroid,Trachea, Esopha;us,Lymph Node (sesenteric),Pancreas,Eye. --------------------------------------------------------------------------------------------- Anizalakumber: Sey: Mile Fa"Le:(keek=106) 'terminaSlacrifice Group: 5) FC-143 300 ppe MacroscopicObservations: MicroscopicObservations: Adrenal heart Liver Lung Pituitary Testis/Epididysis -No visiblelesions. -Siftusoidaelctasia,cortex,si'Ad -Myocardialfibrosis, localareas,mild Myocarditis,Oranic nonsuppurative, local&areas, mild -Portalsononucleacrell infiltratem,ild Cysto;4ddegeneration,ou'Atifocalm,i'4d Megalacytosis,minimal -Vascularmineralizations,ild -Not examined,missing -Vasculartineralizationm,ild The 4ollovingtissueswere foundto be v;lth-n.onrmallimits: Brain,Sp;lnalCkord,BoneNarrow, Spleen,KidiieyS,tomach,Small Intestine,Large lnl,esti.-le, UrinaryBladder,Aorta,Prostate,Thyroid,Parithyroid,Trachea,Esophagus, Lymph Node tmesenteric),Pancreas,SalivaryGland, Eye. ----------------------------------------------------------------------------------------------- Species: Rat Project Number: 0291-I.RO012 Summarized STAR Page: 118 2 8 2 Summarized SingleTabul6ateAdfiiiiRleport(continued) Individualmacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3M FC-143:Tuo Year DrilToxicity-OncogenicitSytudy in Rits Table: 2 --------------------------------------------------------------------------------------- Animal Numbe,,:IR-3631 Sex: Male Group: 5) FC-14'@1,40(pkps Fate:(Week=106)TerainilSacrifice MacroscopicObservations: MicroscopicObservations' Adrenal, Kidney Liver Lung SalivaryGlaid Sp'ieer, -Ka visiblelesions. -Nodularhyperplasiac,ortex,focal,mild Medullarcyellhyperplisiaf,ocil,minimil -Chronicprogressivneephropithya,ild -Portilscionucleacrellinfiltratem,ild Pcrtilbileductproliferatiomni,ld Hepitacytevacuolationl,ocalareas,ikilld Megalocytosi4sm,inimal -Vascularmineralizit@lomno,derate Alveolarmacrophiges,mild Hemorrhage,local areas,maderalt. -Sialidenitisc,hronic,marked ThereNeretwo sectionsof glin:an the slide,onlyone iiisinvolved. -HeBosiderasism,ild The tissueswerefoundto be Nithinnormallimits: Brain,SpinilCord,BoneMirroisH,eart,StociachS,mallIrtestineL,argeIntestine, UrinaryE'AadderA,orta,Test@ts/EpididynPirso,state,Pitui'6iryT,hyroid,ParithyraidT,richea, Esop@igi@s,Lym;,@N.-defiesenter;Ac)P,ancreas, Eye. ----------------------------------------------------------------------------------------- Aninal NL-sber:IR-7;6@42 Sex: Mile Group: 5) FE-14'@300 ppe Fate:(Weekz106)Terair,,Sialcrifice Ma:roscop Cbservitions: Liver TEstis/Epididytis -Fempilefoci. -Palemiss,1.5co dia. MicroscopicObservations: Kidney Liver -Chronicprogressivenephropithy.m,oderate -Portalsone.-tuclceealrlinfilr'a6te,aild Nepatacytveacualitiono,ultifacils,ild Negalocy'6osisi,ld Hepatacytaelterationb,asephilics,ild Singlesubcapsulairreaof bisophilic alter,itionA.boutonehalfof therellshave multiplecytoplasmivcicuoles. Lung -Yisculirm4neraliZ&"4,Dsni,ld Alieclaraitraphagess,ild Hemorrhage,focil,sild Pancreas -Hyperplisii,sletcell,moderate --------------------------------------------------------------------------------------- Species:Rat Pro,iectNumber: 0281CROO12 Sumairize-uSlTAR Page: 11,9 2 8 3 SummarizedSingle TabulatedAnia&l Report (continued) IndividualMa,,roscop4acnd MicroscopicObse-vations RikerLaboratories,Inc. 'V'P, FC-14.1@T:wo Year Oral Taxicity-oncogen@cityStudy in Rats Table: .2 -- ------------------------------------------------------------------------------------------- An-oil Number: IF-36341 Sex: Mile Sroup: 1 5) FE-143 30,1pps Fa'e: (Week=106) Teraina'Sacrifice Microsr;;icObservations-continuedi: T;stis/Ep-"didyo"s -TUbuleatrrphy,aspersitogenesisu,riliteral, marked Leydigcell adenosa,unilateral The fol"Dwi.-'gissueswere foundto be withinnormallimits: Brain,SpinalCc-d, BoneMarrow,Spleen,Heart, Stomach,Small Intestine,Large Intestire. ijririaBr"yaJde-,A.orta,Prost;te,Pituitary,Adrenal,Thyroid,ParitSyro@ldT,rachea,Esop.'.igus, Lyc;h Node 'tesentE@':)S,alivaryBland,Eye. ---------------------------------------------------------------------------------------------- Animal Nucter: Sex: Naie 6roup: 5) FC-147@300 ppe Fate: iweei=106)Teri-',nSaal:r44fice Macroscc;-,cObservations: Eye K.i,.I.iey Micros-,o;iOcbservations: A,,irenil Eye Heart Kidney ive,- Lung Thyroid -Opacity,righteye. -Bilaterallpyaleand pitted. -Sinusaidalectasii,cortex,g@,ld Sarkglioneurosi Large,welldifferentiatetdutor arisingin medulliof one glind. Coo;osedc; nerve fibersand largeganglioncells. -Keril-itisc,hruni@.,moderate -Myocarditis,chronic nonsuppurat4lyE, localareas,iiild -Chronicprogressivenephropathy,marked One of pair present -Portaleananucleacrellinfiltrates,ild Portalbile ductproliferations,ild Cys'Loidegeneration,oulti4ocil,milid Nepato,,ytaelteration,vacuc)lateus4i,ld Negalocytosis,moderate -Yascularsineralizaticns,ild Alveolareacrophages,2ild -Per4visculamronanuclearinfiltrate,minimal Hemorrhage,local areas,sild -Cyst,colloid The followingtissuesmere foundto be withinnereallimits: Brain,Spinal Cord,Eane Narrow,Scleen,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta, Testis!Ep@adidyeiPsr,ostate,Pituitary,Parathyraid,Trachea,Esophagus, Lympt,Made (sesenteric),Pancreas,SalivaryBland. -------------------------------------------------------------------------------------------- Species: Rat Project Number: 0291CROO12 Su2sarized STAR Page: I&lo2 8 4 SummarizeSdingleTabulateAdr,@mRielport(continued) IndividualMacroscopicand Microsc3picObservations RikerLaboratoriesI,nc. 3M FC-141.T:oo Year oral Tcxicity-oncogeniciSttyudyin Rats Table:2 ----------------------------------------------------------------------------------------- Ar6imilN--ater:IR-36."4 sex: male Group: 51 FC-143 300 pps Fate: (Weeks166,TerminalSacrifice 4&crosco;iOctservitiors: Tesl,is/E;-Ididygis Mesentery MicroscopicObservatior-.s: Liver Pancreas Paralthyro44,11 @pleen Testis,'Ep@ididysis -Palomasses,I.ce dia.,in eachtestis. -Mass,3 x 1.5 ce in areaof pancreas. -Portaliionanuclecaerllinfiltrates,ild Cystaiddegeneratioro.u,ltifocaltli,ld Nepatocytealteration,vacuelated,modera'6e NegalDcytosis,minimal -Vascularminerilizationm,ild Alveolaraicrep.@ages,ild -Adenocarc@Incea Large,highlycellula'r,Nell d4t4ferenrtiited neoplasmwithhighmitoticindex. Lymphatic invasion. -Not examined,not in planeof sec4u;.on -Hesas-derosism,ild -Tubul;atraph'ya,speraitagenesibsi,lateral&, marked Leydigcelladenota,bilateral The 4,,illom@1tn@;assueswere ;ou,,itdo be within normallimits: Br,ii-Sip,ina,ro,d,BDne MarroN,Kidney,Heart,Stomach,Small,Intestine,Large Intest'ine, Ur"r,i-B,"fidder,Acrta,Prostate,Pitu4ltarAyd,renal,Thyroid,Trachea,Esophar5i, '@yap,N'o, 6'(eseserttericS)a,livaryGland,Eye. ----------------------------------------------------------------------------------------- Ar.isa!Number'. Sex: Male Group: 5) FC-14'.'400@ppe Fi'le;(Neek.1=06)TerminalSicr4.f;lce MacroscopicObservatio,"S: F@ituitary P,-'&c,-DscDOpbiscervations: Adrenal Kidney Liver -Hemorrhagicarea,0.5 x 0.1&ca. -Medullarycell hyperplasiaf,ocal@,m4.-iral -Chronicprogressive -Portal mor.,6tnu.@'c,eeli'r Lung Pitu;ita-y Salivary61'and -VascullaAl,veollmair:r:;6a;es,s.4',d a--:@'.a, to,-z,-,u-E6a1-. ,-if-1tra'6E, -S;.ilide@4tics@,raric,maried The fol&lowir.t;4assuewsere fa It withinnorsillimits: Brain,Spina'C,ord,Bcni Ki-r3m, Heart,Stona6-hS,a.il!,lntest4ne.L.arge Intestine, ---------------------------------------------------------------------------------------- Rat Przjec4lNumber, 0'-'Ei"@ROO'2 Su3aa,i-ledSTAR Page: "'1. 285 Saaa-4-,E'.Sil;"e In,,ivlduim,a,.,oscop@iacnd 4;1,-roscop4Oihcservitions .ker LibDritorics, FC-14,7:Two Year Or&! St'@dY;.rR.ils Table: ---------------------------------------------------------------------------------------------- Ar,@ima@ Fati: fkec-iz Sex: Ma'Ae 5*,F:l"-14"30'@';Ps os: c;,. c 1.11,servit nue'.' ThE ve-e 40-@r@:-t".@ "rinar)E;-adter,Ac-6"i,i Prosv'i,.te,Thyr.-I@-., I . Trac@ia, 6 @ Nc,@g Far:re;-:s, -------------------------------------------------------------------------------------------------- Eso;hi:@@s, Aniti: NuFter: !R-,;@i Se'.':Ma".E G-c4: 51 FC-147@:I"-;pt i4,p'-, @'*eev= 1,C16) Te--.:-,a'. Sar-r4-14:,e 2tEe,va,icrs: -Swcl".errel-.illirsjiolints, bi',ateralh,i.,i@ r,-.cros-.c;4Ocosevat@@,ns: ;:.-.e Hea!.,@ Kidney Liver un; Lys;,'!Wode laesente-4c) Pancreas Test@s!Epididysis -Boih testes appear sti'll. -Ar+hritis, synovitis; joints, hind'Ae;, moderate -Myocarditis, chronic nons,.,ppu,it;vei,ocal, minis&! -Chrenit progressive nephropathy, minimal -Portal nonanucleat cell ini4.ltrate,gild Portal bile duct pro',i+e-ition,e;ild Cystaid degeneration, foci!, siniial Kegalocytosis, siniial -Vascular mineralization, sild Alveolar microphiges, mild -Sranulesi, oultifocila,moderate -Polyarterit;ls,moderate -Tubule atrophy, aspersitogenesis,biiteri:, marked Polyarteritis, moderate Yascularaineraliza,6.isoinl,d The follovin; tissues were found to be within normal limits: Brain, Spinil Cord, Done Marrop, Spleen, Stosact,, Small Intestine, Large Intestine, Urinary Bladder, Aorti, Prostate, Pitui'tary, Adrenal, Thyroid, Parathyraid, Traciea, Esophagus, Salivary Glind, Eye. ----------------------------------------------------------------------------------------------- S;ecies: Rat Project Number: 0281CROOL" Summarized STAR Page: 122 286 Su2B&rizedSingleTabulatedAniBilRepert (continued) IndividualN&CrOscoP',a,nd MicroscopicObservations R-"kerLi@oritories,Inc. 3M FC-143:TUC Year Oral Toxicity-OncogenicitSytudy in Rits ---------------------------------------------------------------------------------------------- AniallNumber: IR-3637 Sex: Mile Group: Fite: (Weekz106)Teraina!Sacrifice 5) FC-14'.3@00 pps MicroscopicObservations: Thyrr.id Pitu:,16-ary Thymus Micr:c:o;icOt:-ervall-i:7,s: Heart Kioney Liver Lung Pancreas p@,"uitary Di'iiivaGrlyind Thymus -Pessiblys!4g'tlyenlarged. -Mass,0.5 co dii. -Slightlyenlargedand hebcrrhigic. -Nocarditis,chronicnonsupourative, Bultifacil,minimal -Chronic progressivenephropithy,minimal -PortalBononu6leacrelliriiiltritsei,ld Portalbile du,-tproli4erat4aora.i.',4d We--rosis,Bult4,focil&m,oderate -Vascular mineri'Aizat44o-B,iil,ad Hooorrt,agel.o.ci',areas, moderate -Acinir atrophy,sin4,Bal -AdenDea -Not exiained,missing -Hemorrhage, marked The io'4'Aowir';L;issueswere fou@ndtn be within normal limits' Brai,-,, Bone Marrow,Spleen,Stomach,Still Intestine.L,arge Intestine, Uri.-.a@-f Aari-.aT,est4ts/Ep;id@ldy&P4r&oss,l%ite,Adrenal, Thyroid, Firithvrcid,Tric@@ei, Es.-;."a;,.Lsy,s;,'Node tBesenlt-.E,-iEcy)e. ---------------------------------------------------------------------------------------------- Ar.iaa:Number: 1R-"?67@9 Sex: Mile Fa'@e:(Week= 106) Te.-&4&naS'a,crifice Group: 5) FC-14"@7400pps P.a@.ros-.c)Opli.csirvaltions: P;I,u;tiry A-Wlre-ial MicroscopicObserva'6ions: Adrenal -Raised dar--mass, 0.7 ce -Ul@a. -Efkl.irgerdi,ght adrenal -Corticalvacuolial.-ilcoqc,al areas, sadera46-e Sinusoidalectisia,cortex,marked Medullarycell hyperplasia,focal, ci@Ild Kidney Liver Lung -Mineriliz&46icotn),rt;cils,ild -Portalsonoruclearcell infiltrate,Bin@aBa, -Vas-.ulaBrineril;a,,atisoinl,d Alveolarmacrophages,Bild Perivasc-alsBironanucleianrfiltratae:,ilad Hemorrhage,local areas, soder&16,e 6r,inuloBa Fragmentof unidentifiedforeignmaterialin granuloma. ------------------------------------------------------------------------------------------- Species:Rit Project,Number: 0281CROO12 SuBBari:edSTAR Page: 12'j 287 Su2sarizedSingleTabulatedAnimal Report (continued! IndividualMicroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 ------------------------------------------------------------------------------------------------ Anisa! Number: IR-367.9 Sex: Ma'4e Group: 1 5) F'6'-143300 ppe Fate: (Week=106) TerminalSacrifice MicroscopicCbservatio.-(,csontinue'.!: Fancreas Parit@,yro@l,.' Pituitary 4 2@', -Not exa2fned,missing -Not examined,not in plane of section -Adeno2i -Henosiderasiss,ild The followingtissueswere foundto be withinnormallimits: Brain,S;inalCord, Bone @'llarroHwe.a,rt,Stomach,Small Intestine,Large Intestine, UriniryBladder,Aorta, Tes'is/Epid4Ldys'Psr,ostate,Thyroid,Trachea,Esophag-as, Lymph Node @keesenteric)S,alivary Slan4l,Eye. ------------------------------------------------------------------------------------------------- Animal Nuaber: Sex: @.ale Sroup: 51 FC-147@300 ppi Fill-ei:weeiz 72) Sacrificed;anextresis Mi:rosccpicObservitiois: cqple;n. Abdcae.(-i.iternil) Eye M-acroscop@cObservations: Adrenal Eye Kid.,.e,f Liver Lung Spleen Stomach -Possiblysmallerthan normal. -Gastrointestinatlract from stomachto cecus distendedNith gas. -Righteye slightlyatrophied -Nodular hyperplasia,cortex,focal, s@anisall -Keraluitisa,cute, marked Lesionin righteye. Extensivecorneal ulceration. -Calculus,pelvic,sild -Portalgononu,.Iecaerllinfiltrates,ild negalocytosiss,iniall -Vascularsiieralizatiorm.i,ld Alveolareacrophiges,itild -Heacs-'Aderasissi,ld Atrophy, moderate -6&s'Lritiasc,ute,diffuse,sild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Heart,Stal! Intestine,LargeIntestine,UrinaryBladder, Ac.r'.iT,estis/Epid@idyaisP,rostate,Pituitary,Thyroid,Parathyrai@@T'r,achea,Esophagus, Lymph Node (aesenter4Ac)P,ancreas, SalivaryBlin4u. ------------------------------------------------------------------------------------------------ Species: Rat Project Nuaber: 02B!CROO12 Summarized STAR Page: 124 2 8 8 Summarizedsingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations Riker Laboratories,Inc. 7@H FC-1414:Two Year Oral Toxicity-oncogenicitSytudy in Rats Table: 2 ---------------------------------------------------------------------------------------------- Anisa' Nutter: IR-4@641 Set: Male Fate: (Week=106) TerminalSacrifice Group: 5) FC-14'v3?03 ppi Microscopicobser-iations' Liver O@servations: A,,'rer-a'. HEar@@, Kidr.ey Liver Lung Pancreas 5;"ee,-i Tesfisi'E,,4,didys'is -Yellowishfoci, 0.3 ce d4aa.,median lobe. -Medullarycellhyperplasli,local areas, -Myocird-Itisc,hronicnonsuppurative, oultifocalm,ild -Chronic progressivenephropathy.,todera*e -Por'6alsononuclearcell ir,441"t,-ItE, Cystaid degeneritior.o,ult@Afocals,ild Megilacytosis,minimal Hyperplasticriodule Circumscribed,expansive lesion w@'@h preservationof noraalarchitecture.Forl@al areas present.Cellsin nodule &ore basop@;@14;4cv,icucla'Led. -VascLIar ainerilizaluio-&P4,1"d Hemorrhage,fecal, sild -Ac@anaratrophy, moderate -Hemosideros4iss,ilid -Leyd,*Icgell&adenosa, unilateral T'!-fcoilowing 11-@ssuewsere found te be normal limits: B-ii.r.L,.piril1.6'@rdB,ore Yarro*. S+osic@,Small Intestine,Large Intestine,Urinary Blid@@e-, A-.@rtaP,rostil,eP,ituitary,Thyroid,Parithyroid,Trachea,Esophagus,Lyaph Role (tesenteric), Eil@iviryIzland,Eye. ---------------------------------------------------------------------------------------------- Animal,Number: IR-3644 Sex: Male Group: Fate: (Week=10ii Teraina'Sacrifice 5) FE-14'-3?0, pps Macroscopic Observations: L-Aver -Appears mc'6tle4js;sa'A:pale a-ei in se,.4@ar lobe. Microscopic Observal.@lors: Adrenal& Heart Kidney Liver -Corticalvac-jclationf,ocal,s@&id No,.Iulahryperplasia,cortex,focal, iil,61 -Hya-,arditisc,hronicnonsuppuratiye, oult@afocal,mild -Chronicprogressiveneph-opithy,minimal -Port;"mororuclear-.ellin4-'Altrataei,*,d Portalbile duct proliferationm,ild Mega'DEytOSiS, minimal Hyperplasticnodule Cellsof nodulehave slightlymore basophilic cytopl&asamiany are vicualited. --------------------------------------------------------------------------------------------- Species: Rat Project Nuaber: 0281CROO12 Summarized STAR Page: 125 289 SummarizedSingle TabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObserv&t'Ons RikerLaboratoriesI,nc. 3M FC-143:Two YearOral Toxicity-OncogenicitSytudy in Rits Table: 2 --------------------------------------------------------------------------------------------- Animil Number: IR-3644 Sex: Mile Group: Fate: (Weeks106)TerminalSacrifice F"6-143300 pps Microscopic Lung Observa'@ioniscantinued): SilivaryGland Tes+is/Epididy2is -Vascularmineralizations,ild AlvEalar aicrophages,o@1A. -Sialaderitisc,hronic,marked -Vasculars@,neralizationm,oderate The idliowingtissueswere foundto be withinnormal,limits: irain,SpinalCord,Done Narrow,Spleen,Stomach,Sail' Intestine,Large Intestine, Ur@,-.arE,'iaAIer,Aorta, Prostate,Pituitary,Thyroid,Parathyroid,Trachea,Esophagus, lyapt!Nod; (sesenteric)P,ancreas,Eye. --------------------------------------------------------------------------------------------Animal Number: IR-74645 Sex: Male Group: "w@)FC-141@ 300 pps Fite: (Week.=106)TerminalSacrifice MicroscopicObserva,6iors: Testis/Epid4,dysis -Palaemass,I.!.co dia.,in le4t testis. P.icroscapiOcbservations: Adrenal Ar,rlt.i Esop.6'agus Kicney Liver -Modularhyperplasia,cortex,oultifocal,mil-ul -Metastaticneoplasm -Notastiticneoplasm -Chronicprogressivenephropithy,s'.1d -Portalsonanucleicrell in4itrate,minimal Portalbile ductproliferationm,inimal Regalocytosis,minimal Lung -Yascularmineralization,a4Ald Pneugan@La,.ip.',erstitcih,rioln,4c,sul"ifo@.all, gild Alveolarsacrophiges,sild Hemorrhage,focall,aild Pancreas Parathyroid Salivary Slar.4@ Soft Tissues(thorax) -Acinaratrophy,mild -Adencei -Sialadenitis,chronic,moderate -HistiocytolaM,alignant Diffuseinfiltratoef histiocyticcellsin sed;las',@itniaslsues. Moderate number c4 oultinjcleatgeiantcells. Infiltrate extends into muscle &roundbone. Spleen -Hemosiderasis,mild Testis/Epididysis Trachea -Leydigcell adendga,unilateral -Metastaticneoplasm Urinary Bladder -Epithelialhyperplasia,simple,dif4use, minimal -------------------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 Summarized STAR Page: 126 2 9 0 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Taxicil,y-OncogeniciSttyudy in Rats Table: ----------------------------------------------------------------------------------------------A,iiialNumber: LR-3645 Sex: Male Group: ( 5) FC-143300 ppe Fil.e:(Week=106) TerminalSacrifice MicroscopicObservations(continued): The f."",Dwngtissueswere foundto be withinnormallimits: Brain,Spina,Card, Bone Narrow,Heart,Stomach,Small Intestine,Large Intestine,Prostate, Pituitary,Thyroid,Lyspl.N-oilue(seserteric)E,ye. ---------------------------------------------------------------------------------------------Animal Nut@er: IR-4641 Sex: Fesalle Group: 5) FE-141,1.01@p,pe Fale'.ikeekz 7:) Si.,riiice-dinextresis Mi:rc)sccpiOcbce-vatioris: MillaryGland Microscopic Obse,-Yat;ao,-is: Adrenal Esophagus K;.drey Lur,; Mammary Gland oyary Sal;.YarvGland -Large oultilaobulasrubcutaneousmass.,leit ;Lngu4n,ialntd per;inE&'a,,ea, 10 x 7 x 14.5ca. Mass ulceratedan the .4orsal su,face;insidecysticwith silky fluidpresent. -Sinusaidalectasia,cortex,marked -Not examined,missing -Chronicprogressivenephropithy,minisi'A -Portalbile duct proliferation&,4,ld Hepatocytealteration,vacuclated,facil, licisal -Hemorrhage,loca'Aareas, mild Alveolarmacrophiges,sultiiocil,mild -Fibraidencea -Not examined,missing -Not exisined,missing -he 40!!Dllirgtissues mere found to be within noraal limits: Brain, Spin&! Cord, Bone Narrow, Spleen, Heart, Stomach, Small Intestine, Large Intestine, Urinary Bladder, Aarti, Uterus, Pituitary, Trachea, Thyroid, Parithyraid, Lyspil-N;ode lsese-iter;ac)P,ancreas, Eye. -------------------------------------------------------------------------------------------------- Animal Number: I&R-4643 Be:: Fesile Group: ( 5) FC-14'.3@00 ppe Fite: (Week-- 78) Sacrificed in extresis Racraszop@Ac Observations: Pituitary -Hemorrhagic mass, O.B ce dia. Microscopic Observations: Esophagus -Not examined, missing Kidney -Pelvic sineralization,mild Liver -Hepatocyte vacuclation, diffuse, mild ------------------------------------------------------------------------------------------------ Species: Rat Project Number: 0261CROO12 Summarized STAR Page: 127 291 aridlbxk_oiogy Wow .Inc. Buik*ng270,-iS4M.3M Comer SL PaLd.Minrmm 55144-1000 TWO YEAR ORAL (DIET) TOXICITY / CARCINOGENICITY STUDY OF FLUOROCHEMICAL FC-143 IN RATS (RIKER EXPERIMENT NO. 0281CROO12) VOLUME 2 OF 4 CONDUCTED DURING APRIL, 1981 - MAY, 1983 RIKER LABORATORIES, INC. / 3M COMPANY ST. PAUL, MINNESOTA 55144-1000 U.S.A. Suu&f;*ZSfidnglTeabulatAendimaRleporltcortinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-147.:Two Year Oral Tax;acity-OncogeniciSttyudy in Rats Table:"I ---------------- ----------------------- -------------------- ------------------------ AnimalKusber:IR-4643 Six: Female Group: 5) FC-143300 ppt Fate:lweekz78) Sacrificeidnextresis MicroscopiOcbservations(continued): i.urlg LymphNode (sesenterit) Farathyroid Pi'6-uitary Spleen Uterus -Vascularsintralizat-Acsni,ld Nescrrhage,diffuse,marked -Not examined,missing -Notexamined.not in plantof section -Adecosa -Homos@aderosis,moderate -Cysticglands,mild The fo'alovintgissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,Small Intestine,Large Intestine, UrinaryB'AadderA,orti,Ovary,HassaryGland,Trachea,Adrenal,Thyroid,Pancreas, SalivaryGland,Eye. -------------------------------------- - --- --- ----------------------------------------- Animal Number: I.R-4644 Sex: Female Group: 5) FC-143300 ppg Fate:(Neeka105)TerminalSicrifice MicroscopicObservations: Mammary Slar.,.' MicroscopicObservations: Adrenal Kidney Liver Lung HassiryGland P,incre5 UrinarayBladder -Lobtlarmass,7vre d;aa.r,ightaxilli. -Sinusoidaelctisia,cortex.aild -Pelvicmineralizationm,inimal -Hipitacytveicuolationo,ulti4ocalm,ild Repatocytoalterationv,acualitedf,ocal, mild Hepatocytailterationb,asophilicf,ocal, minimal Hyperplasticnodule -Vascularmineralizatiosni,ld Alveolarmacrophagtso,ultiiocalm,ild -Fibroademn -Not examined,missing -Not examined,missing The followingtissueswe foundto be withinnormallimits: Brain,SpinalCord,lontNarrow,Spleen,Heart,Stoasch,SmallIntestineL,argeIntestine, Aorti,Uterus,Ovary,Pituitary,Trichea,Thyroid,ParathyraidE,sophagus, LymphNode (sesenteric)S,alivaryGland,Eye. - --------------------------------------------------------------- species:Rit Project Number: 0261CROO12 Summarized STAR Page: 129 292 Suuarized SingleTabulatedAnjul Report(continutd) IndividualMacroscopicand MicroscopicObservations - ---- -------- Riker LaboratorietIlnc. 3H FC-143:Too Vear Oral Toxicity-UntagenicitSytudy in Rats Table: 2 ------ ------------------------------------ --- ----- -- --- --------- Ar@isalNumber: IN-4645 Sex: Female Group: 94)FC-143 300 ppe Fate: (Keek-105)TerminalSacrifice MacroscopicObservations: R.13fia-gYland Hicroscop4AcObservations: A4urenal Aorta Kidney Liver Lu-.ig Lymph Node (tesenteric) Hastary Si.a,-id Pirathyrcid Fituita,y -Largemass,10 x 4 ce, rightaxilla;lobulir &ass,5.5 x 5 x 4 ce, leftinguinal. -Sinusoidaleclasia,cortex,marked -Not examined,missing -Pelvicaineralizat4&osni,ld -Portalsonanucleicrel,4infiltratea,ild Portalbiltductproli4trationm,ild -Alveolarmacrophages,sultifocal,mi.ld Hemorrhage,local areas,sild -Htaorrhage, marked -Fibroadenosa -Not exim-6ned,not in plant of se.-I.ion -Adenoaa The tissueswerefourdtc be withinnortallimits: Sp@&riaC*o.r.4,Boi-,Nearrow, Splier.,Heart, Bl@Oaa:h,Small Intestine,Large Intestine, Urip.a-yGladder,L!terus,Ovary, Trachea,Thyroid,Esophagus,PancrelisS,alivary61ind, Eye. ------ --- ----------------------------- Animal NLAbir: IP.-4646 Sex: Female Group: 5) FC-143 300 ppe Fai6-e(:Weei-I-C5) 'ierainalSacrifice Macros-.opicObservations: Mammary Blind -Smallnodularmiss,I ca dia.,leftaxilla; nodularmass, 4 1 2.1.c1a, right MicroscopicObservations: Adrenal Hear,, Kidney Liver Lung Mammary Gland Ovary Pancreas Pirithyraid --------- ----- ------------- -Sinusaidalactasis,cortex.moderate -Myocardialfibrosis,focal,miiisa! Wyocarditis,chronicnonsupparative,focal, minimal -Chronic progressivenaphropathy,minimal Pelvic sintralizationm,arked 4ortal eonorucleacrellinfiltratem,ild -Hemorrhage,local areas. moderate -Adenocarcinomi Fibroadenoma -Tubularhyperplasii,moderate -Aciniratrophy,sin-*Aaal -Not examined,not in plane of section - - ---------- ------------------------- -- Species:Rat Project Number: 0281CROO12 Busw ized STAR Page: 129 293 Suntrized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand Microscopicobservations RikerLaboratories,Inc. 3H FC-143: Two Year gra'AToxicity-OncoggnicitSytudy in Rats Table: 2 - ------------------ - ------ ------------------ - ---- ----------- ------------- Animal Number: IR-4646 Six: Female Group: 5) FC-143300 pps Fite: (Weeks105)TerminalSacrifice MicroscopicObserva"6ion(scontinued): Pituitary Salivary61ind Uterus -Adencaa -Not examined,missing -Cystic,glandsm,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord, Bane Narrow,Spleen,Stomach,Small Intestine,Large Intestine, Urir,aryBladder,Aorta,Trachea,Thyroid,Esophagus,Lymph Node (sesenteric),Eye. ----------------------------------------------------------------------------------------------- Ar.;,maNlumber: IF.-4647 Sex: Female Group: 5) FC-143 300 ppe Fite: (Weeks105) TerminalSicrifice MacroscopicObservations: Pituitary microscopicObservations: Adrenal Esophagus Kidney Liver ,6u.ig Ovary Parathyraid Pituitary Thvrcid Trachei Urinary ilidder -Hass,0.5 ce dia. -Sinusoidalectasia,cortex,marked -Not examined,missing -Chronicprogressivenophropathy,minimal Ptlvi:mineralizationm,inimal -Nepitacytevicualitions,ultifoc&14a,ild -Vascularmineralizationm,oderate -Cyst,unilateral -Not examined,lissi-.ig -Adencet -Not examined,missing -Not examined,missing -Not examined,missin; The folloo'ngtissueswere foundto be withinnormi'.limits: Bri;,,IS,pinilCard,Bone farrow,Spleen,lieart,Stomach,SmallIntestine,Large Intestine, Aorta,Uterus,Hisairy61&nd,Lymph Node (sesenteric)P,ancreas,Salivary61and, Eye. -- ------------------------------- ---- -- --------------------------- ---- ----- --- --- Animil Nuaber: IR-4649 Six: Female Group: 5) FC-143 300 ppe Fate: (Weeks 86) Found Dead MacroscopicObservations: Mammary Bland MicroscopiOcbservations: Eye Kidney LargeIntestine -Largefire subcutaneousmass, 12 x 9 x 5 ca, on leftside. -Not examined,missing -Pelvicsineralizitions,ild -Not examined,aissing Species:Rat Project Number: 0201CROO12 Summarized STAR Page: 130 294 SummarizedSingle TabulatedAnimal Report (ccmt4.nued) IndividualMicroscopicand MicroscopicObservations RiterLaboratoriesI,nc- 3" FC-147?:Tvc Year Oral Toxicity-OncogeniCitSYtudy in Rati --- -- ------------------------------------------------ - -----------Ar@'silNuaber: IR-4648 Sex: Fmall Broup: 5) FC-143 300 ppe Fate: (Meek= 88) Found Dead Table: 2 MicroscopicObservitims (continued): Lung LymphNode (sesenteric) Mammary Gland Parathyroid. Skin Beal'A1,,.test4Ane -Vascularmintralizatim,sild Alveolarmacrophiges,oulti4ocal,sild Perivas-.ulsamranuclear infiltratea,ild -Not examined,missing -Not examined,missing -k,6 examined,not in planeof section 4ibroma -Not exasifiedm,issing The following''issuewsere foundto be withinnormallimits: Brain,SpinilCcrd, Bone Narrow,Spl&een,Liver,Heart,Stomach,UrinaryBladder.Aorta,Uterus, Ovary,Pituitary,Trachea,Adrenal,Thyroid,Esophagus,Pancreas,SalivaryGland. ------ - ------------------------- - ---------------------------- Ar-.isaNluamber: IR-4649 Six: Female Group: 5) F'6-143300 ppe Fate: (Meeks105)TerminalSacrifice Macroscopic Observat@&ons: Pituitary HatairyBlind M44croscop44cObservat@Aer..s: Adrenal& Kidney Liver Lun; Na&airy Gland Ovary Parathyroid Pituitary SalivaryGland -Raised3ass, 0.6 ce dia. -Smi'Ll&ass, I ca dia., possiblyin4litase-ul milk cyst,peranoilarea. -Corticalatrophy,bilateral,acderate -Chronicprogressivenephrop&46hys,ild -Portalsmonucleircallinfiltratem,ild Portalbile ductprolifera'6-iosr4.6,ld -Perivascul.saornmuclear infiltrate,minimal Fibroade,-icia -Tubularhyperplasia,bilateral,moderate -Not examined,not in plane 04 section -Adenosa -Not examined,missing The followingtissueswere foundto be withinnormal limits: Brain,SpinalCard, Bone Narrow, Spleen,Heart, Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,L14,erusT,richea,Thyroid,Esophagus,Lymph Node (sestateric),Pancreis, Eye. ---- - - ----------------------------------------------- -- --- ---- -- -- -- ------- Species:Rit Project Number: 0201CROOII& Su"arized STAR Page: 131 295 BuslarizedSingleTabulatedAnimalReport (con4inued) IndividualK&croscopicand Microscopicobservations RikerLaboratories,Inc. 3H FC-147.T:oo Year oral Toxicity-OneagenicitSytudy in Rits Table: 2 ------------------------------------- ------ - - -------------------------------------- Animal Number: JR-4650 Sex: Female Group: 5) FC-14'v300 ppe Fate: (Week-1-04)Sacrifitedin extre@;As Ma.-roscapicObserva";.crts: Pituitary Skin Pista.-yBland MicroscopicObservat;cns: Adrenal Kidney Liver Lun; RiatarySlind Dvary Parithyri)id Pituitary Skin -Hisarrhagic&ass, 0.1 cc dii. -Raisedcircularin4lissedlesicnon leftr.ear footp@d. -Round mass,I co d4la.,in inguinilarea. -Sinuscidalectasia,cortex,mild Medullarytell hyperplasii,uni,ateral, moderate Pheachroaccytosam,alignant,unilateral Infiltratioonf necp'Aastitcissueinto surroundingconnectivetissue. -Pelvicsineralizations,ild -Portilsonanucleacrell infiltrates,i!d Portalbileductproliferations,ild Nepatacytovacuclatiofts,ulti4oca*,m,i,ld -Vascularsifkerilizatiomni,ld Porivasculatrwonuclearinfiltrate,minimal -salactocile -Tubularhyperplasia, moderate -Not examined,not in plane of se.-ticin -Adenm -Pododermati.'6uilsc,erative,hirdleg, unilateral,marked The 4ollowingtissueswere foundto be Aithirn,crtallimits: Brain,SpinalCard, Bone Hirrom,Spleen,Heart,Stomach,Small Intestine,Large Intestine, Urinary Bladeer,Ac.-16-Uat,erus, Trichea,Thyroid,Esophi;us,Lymp@,Node (mosenteric),Pancreas, Salivary Eye. - ----------------------------------------------------------------- -- ------------------- Animal Nurber: IR-465! Sex: Female Group: 5) FC-14.'300 pps Fate: (Week= q6) Sacrificedin extrea4bs P,,i@,roscepOibcservations: Pituitary -?aisedmass, 1.1 cc dia. MicroscopicObservations: Adrenal -Sinuscidalectasia,cortex,mild Esophagus -Not examined,missing Eye -No'%examined, missing Large Intestine -Not examined,missing Liver -Hipatacytoalteration,vicualated,4ocal, mild --- - ---- ----------- ----------------------------------------- --- ---- - ----- Species: Rat Project Number: 0291CROO12 Sumarized STAR Page: 132 296 SuasirizedSingleTabulatedAnisalR,eport (continued) IndividualMacroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3" FC-143:Two Year Oral ToxicitY-OneagenicitSytudy in Rats ------------------------------------------------ Table: 2 - - - ----------- Anisa'aNumber: IN-4651 Sex: Female Group: 5) FC-143 300 ppe F&4ue:(Wetkz 96) Sacrificedin extresis N@AcroscapiOcbservationsItantinued): Ovary Parathyraid Fituitary SalivaryBlard Thyroid UrlraryBladder -go diagnosis,inadequatesection -Not examined, missing -Adencoa -Not examined, missing -Not examined, missing -Not examined, missing The followingtissueswere foundto be withinnormal,limits: Brain,SpinalCard, lone Marro*,Spleen,Kidney,Heart,Lung, Stomach,Small Intestine,ADrta, Uterus, Mammary glaand,Lymph Node (aesenteric),Pancreas,Trachea. ------------------------------------------ -- -- -- ----------------------- Anisa'4Nuaber: IR-4653 Box: Female Group: 5) FC-143 300 ppe Fati: (Neekz 97) Sacrificeidn extriais MacroscopicObservations: Pituitary Hismary gland Liver M;#,,rosccpiOcbservit4ons: Adrenal Escpll.a;us Kidney L'Aver Lung Hastary Bland Paacreas Pituitary Spl&eer. -Hemorrhagic mass, 14co d4sa. -Milkcystin ri;htinguiriaalrea. -Pall -Sinuscidalectis4lac,ortex,mild -Not examined,missing -Chronicprogressivenophrepathy,minimal -Wepatacytevacuo'Laticnd,;.ffuse.marked Monanu,-Ieicrell.infiltration,oull.@lfacal, parenchymal,sild -Pneumonia,interstitialc,hronic,oultifecal, minimal -Wit.@44noreala 14&a;.ts Milk cyst not includedwith sectionexamined. -kinar atrophy,mild -Ad"oaa -Nmosiderosis,sild The followingtissueswere foundto be within normal.limits: Brain,SpinalCord, Bone Narrow,Heart,Stomach,9"11 Intestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Trachea,Thyroid,Parithyroid,Lymph Made (sesenteric), SalivaryBlind,Eye. - - ---- ---- ------- -------------------------------------------- SpK4es: Rat Project Number: 0201CROO12 Sumarized STAR Page: 13.7 297 Sumlir..SZigndgleTabulateAdnjul Report(captifiutd) IndividualR,acruSCOPICand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Two YearOralToxicity-%coginicitSytudyin Rats ------------------------------------------------.1@ - -- ---- Ani.salNumber:IR-4654 Six:Fesile Group: 5) FC-14%13000 ppe Fate: (Neekz 57)FoundDead Table:2 - --------- ,r.acroscop@&Ocbservations: RasairySlind Hicruscop4AOcbservil.ions: Aarenil EsOphagLS Heart Liver Lung Mitairy Sliand Pancreas -Subcutaneoumsass,6 x 5 x 2 ce, in left axilla.Mass wasoultilobulaarnd reddishpink. -SinLscida@l,-tisiic,drtex,moderate -Nct exi2inod,missing -Kyoca,-dil%,c4h4rso,nic nonsup,",urativfec,:al&t B&r.isa! -Portalbileductproli.firatisoirlid, -Pneumoniai,nterstitialc,hronic,facil,mild 4ibroadinazi -Pancreatitisc,hronic,diffuse,moderate 'ihefol,',o%itnigssueswere foundto be Nithinnormallimits: Br&44.-S.p,ir@alCar,!-dB,v,,eNarrow,Spl.ten,Kidney,Stomach,Small Intestine,Large Intestine, Bladder,Aorta,Uterus,Oviry,Pituitary,Trachea,Thyroid,Parathyraid, Lymp.1N1ode -,cesenteric)S,alivaryGland,Eye. ------------------------------- --- --- - --- ------------ ---------------- AnimalNuabtr:IR-4657 Sex: Female Group: 5) FC-143300 ppe Fite:(Meek-1-05)'I'ersinSaalcrifice N.icroscapiOcbservations: HismiryGland MicroscopicObservations: Adrenal Eye Kidney Liver Rateiry61ind SalivaryGland Spleen UrinaryBladder -Labularmass,2 x 1.5 x I ce, in perinell area. -Sinusoidaelctiisiac,ortex,sild -Notexamined,missing -Chronicprogressivene;@rorathy,@;4'6d Pelvicsintralizatiosri,l,d -Portalsoncnucleicrallini;#Itrit@e;,Ald Portalbileduct proliferatica-4t,ld Hipat-@cytvoicuol&16,icoru.l,altifecamli,ld -Fib.-cadicosa -Sialiden-&ticsh,r3nit,eaderate -Honasiderosism,ild -Not examined,missing The follov-*.tnigssueswere found tc be withi-,n,o.rma'Alimits: Brain,SpinalCord,Done Narrow,Heart,Lung,Stomach,Small IntestineL,argeIntestineA,orta, Uterus,Ovary,Pituitary,Trachea,Thyroid,Parithyroid,Esophagus,LymphNode (usenter@&c), Pancrais. -- ------------- - ----- Species:Rat Project Number: 0261CROO12 Sumarized STAF Page: 134 298 SummarizedSingle TabulatedAnimal Report (Continued) ln4wividuaRlacroscapic Ind HicrosropicObservations RikgrLaboratoriesI,nc. 3M FC-143:Two Year Oral Toxicity-OncoginicitSytudy in Rats Table: 2 ----------------------------------------------------- ------------------ --------------- Animil Nuabir: IR-46SO Sex: Female Group: 5) FC-143 300 pps Fate: (Week=105) TerminalSacrifice MicroscopicObservations: Miaeary Blind MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lymph Made (mesenteric) Mastary Blind Ovary Parathyroid SalivaryBlind Sp'ieer, Tt.yroid 7r&chea -Kilkcystin pirinealarea. -S;&nLsoidaelctasii,cortex,marked -Not examined,missing -Myocarditis,chronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropathy,mild Pelvicmineralizationm,inimal -Nepatocytevacuolition,oult;.focalm,i'Ad negalocytesis,minimal -Hemorrhage, moderate Pigment, brown, moderate -Fibrosis,mild -,.*ys"u,nilateral -Not examined,missing -Not examined,missing -Hetosiderosisa,ild -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Bri;An,SpinilCard, Pzre Narrow,Lung,Stomach,Stall Intestine,Large Intest'sne, Urinary Bladder,Aorta,Uterus,Pi,',u;,taPrayn,creas,Eye. ----------------------------------------------------------------------- ------------------ An4ailWisber: IR-4LS9 Sex: Female Group: Fa'Le: (WEekz 105, Torii'AnilSacrifice FC-143 30A@ppi Microscopic Ob;ervat@.c-is: Mammary Slan'. HicroscapicDbservitirns: Adrenal Aorta Esophagus Kidney Liver Lung Naaaary Gland Pancreas - - - ------------------ -Labular3 s 3 co mass in throatarea. -Sinusaidalectasia,cortex,moderate -Not examined, missing -Mt examined,missing -Chronicprogressivenophropathy,moderate Peiv;,mcinerilizatione,irisal -Portalsononuclearcoll infiltrate,minimal Portalbileduclkproliferalicns,ild -Vasculara;@neralizationg,ild Perivisculasrononu,,Ieianrfiltrates,ild -FibrDadenoma -Acinaratrophy,sild Islet Coll adenoaa - --- --- - Spec'.es:Rat Project Number: 0221CROO12 Summarized STAR Page: 135 299 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:TwoYear OralToxicity-kcogenicitSytudyin Rats Table: 2 ---------------------------------------------------------------------------------- Animal Number: IR-4659 Sex:Female Group: t 5) FC-143300 pps Fite: lneeka105)TerminalSacrifice Microscopic Observations(continued): Uterus -Folyp The 4ollaisintgissuesoere foundto be vithinnormal limits: Brain,SpinalCard, bone Marro%,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Ovary,Pituitary,Trachea,Thyroid,Parathyraid,Lyapt,Node (sesenteri.-), SalivaryGland,Eyt. ------------------------------------------------------------------------------------------- Aniaa'ANumber: IR.-466C Sex: Female Group: 5) FC-143 300 ppe Fite: (Week=105) TerminalSacrifice Ma,.roscep4kO,b,serviluions: Pituitary Mammary Blind MicroscopicObservatiors: Adrenal Esophagus Kidney Large Intestine Liver f6 un; LymphNode (stienteric) Mineiry 61and Pan.-reas Paratt.yroid Pituitary Spleen -Hasr,,0.6 en dia. -Mass,2.5 x 2 1 3 ca, leftaxilla;miss,4.4 1 4 1 2 ce, leftinguinal. -Sinuscidalectasia,cortex,marked -Not examined,missing -Chronicprogressiventphropithy,sin4seal Pelvicsinralization,minimal -Nnitudiisisc,olei -Portalsmonuclearcellinfiltrates,ild Portalb&ile duct proliferatione,ild Hopatocytovacuelation,BulAti4ocale,irisal Cystoid degenerativ.,4ocal, @44nisal -Alveolaria-,rophagesf,ocal,mild -Pigment,brovn, mild -Fibroadinoaa Fibroadencei -isletcell carcinoma -Not examined,not in plantof section -Adencea -Hosesiderosis,minimal The failoningtissueswere foundto be vithinnorma@limits: Brain,SpinalCard, Done Marrov,Heart,Stomach,Small Intestine,OriniryBladder,Aorta, Uterus, Ovary,Trachea,Thyroid,SalivaryGland,Eye. - - - -------- ----- ------------------ --- ---------- --- ---- --------------- Species:Rit Project Number: ONICROO12 Suseariztd STAR Page: 136 300 SummarizedSingle TabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations Riker LaboratoriesI,nc. 3" FC-143:Too Year Oral ToxititY-OncogenicitSytudy in kits - ---- -------------- ------------------------------------------Anisal Number: IR-4661 Sex: Female Group: 5) FC-147V300 pps Fate: (Meet=105)TerminalSacrifice Table: 2 MicroscopicObservations: MicroscopicObservations: Esophagus Kidney Liver Lu,i; Parat@@yroid -No visiblelesions. -Not examined,missing -Chronicprogressivenephropathy,minimal -Pe-talsononucleicrellinfiltratea,ild He;atocytevatuolationo,ultifocil,sild -Vascularmineralization,milad Alveolarmacrophageso,ultifocal,sild -Not examined,not in plane of section The followingtissueswere foundto be withinnormal limits: Brain, Spi-,iaClord,Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryB:adder,Aar'%&,Uterus,Ovary,RassiryBland,Pituitary,Trachea,Adrenal,Thyroid, Lymph Node (sesonleric),Pancreas,SalivaryGland,Eye. -- ---------------------------------------------------------------------------------------- Animal Number: IR-4662 Sti: Female Group: f 5) FC-14'v300 pps File: (Weeka105) TerminalSacrifice M,icroscop4&Ocbservations: Mammary Bland MicroscopicObservations: Adrenal Esophagus KiAney Liver Lung Lymph Node (sesenteric) Mammary Gland Pituitary Spleen -Ulcerated necrotic mass, 4 1 3 co, in right inguinalarea. -Sinusaidalectisia,cortex,marked -Not examined,missing -Chronicprogressiven"hropit@.y,sild -Portalsononucleacrell infiltrates,ild -Vascularmineralizationm,ild Hemorrhage,oultifocal,mild -Pigment,brown, moderate -Fibraidenosi -Adenzaa -Nesatopoitsise,xtrasedullaryi,ncreased, marked The followingtissuesmere foundto be withinnormallimits: Brain,SpinalCord, Done Narrow,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBliddu , Aorta,Uterus,Ovary,Trachea,Thyroid,Parathyroid,Pancreas,SalivaryGland, Eye. ---- --- -------- --- --- - --------------- -------------------- SpeciesR:at ProjectNumber:0281CROO12 SummarizeSdTARPage:137 301 SummarizedSingleTabulatedAflimlReport (continutd) IndividualMacroscopicAnd Microscopicobservations RikerLaboratoriesI,nc. 3H FC-143:Tvo Year Oral Toxicity-oncoggnicitSytudy in Rats Table: - -- - -------- - ----------------- - --------- ------------- -------------- Anizal kusber: JR-4663 Sex: Fatale Group: 5) FC-143 300 pps Fate: (Week=105)TtreinilSacrifice MicroscopicObservations: Hastary Bland Adrenal. Hicrescopi:Observal@ions: Adrenal Kidney Liver L@:,g f,immaryBlind Pirithyreid -Miss,3 1 '&.5ce, in the throatarea. -Night adrenalappearssmall. -Sinuscidielctasii,cortex,unilateral,, moderate -Chronicprogressivenophropithy,ei&ld Pelvicmintrali,&'6iosni,ld -Portalno-lonucalr; cell infiltrate, milad Hiplitucytveacuol&ltiono,ultifocal,1;&Ie Nepatocytealteration,vacual@atedf,ocil, sild -Alveolareacrophages,local areas,mild Hemorrhage, mild -Fibroadencei -Not examined,not in plane of section The follois;&tni;ssuesNere foundto be vithinnormallimits: Briii,.S,p4i&'&CDr,#,Bone Narrow,Spleen,HeaFt, Stomach,Small Intestine,Large Intestine, Uri.-i,i1r',4.&,d!er,Aerlu-iU,te-us,Ovary, Pituitary,Trachea,7hyraid,Esophagus, lyaphRode isesenteric)P,ancrtas,SalivaryBlind,Eye. ------------------------------------- --- ------- - ------ -------------- Anita! Num6@er:IR-4665 Six:Fesile Brou;: 5) FC-143 300 pps Fal.e:(Week= 14) Sacrificedin extrimis MacroscopicObservations: Pituitary Hassiry Blind MicroscopicObservations: Adrenal Esophagus Kidnev Liver Lu.,tg Lymph Node (mosenteri".) mis"ry Slane Ovary Spleen -Raised red mass, 1.2 ce di;. -Smallmilk cyst present. -Sinusaidil&e.-tisiac,ortex,mild -Not examined,missing -Chronicprogressivenaphropathy,oin4.2a, Pelvic mineraliz&16-iomni,nimal -Portilmanoruc!eicrtllinfiltrates,ild Port&!bileduztproliferationm,ild -Vascularsine-alizationm,ild H"orrhage, localareas,mild -Net examined,missing -Labularhyperplasia,a3derate -Tubularhyperplasia,moderate -1wencel -4@osiderosis,mild -- -- ---- ---- ---- ------------------- Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 136 302 SummarizedSingle TabulatedAnimal Report (Continued) IndividualMicroscopicAnd HicroscoPicObservations RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Toxicity-DneagenicitSytudy in kiti ------------ - -------Animal Number: IR-4665 Sax: Female Group: ( 5) FC-143300 pps Fate: (Week= 94) Sacrificedin extresis Table: RicroscapicObservations(continued): LI'lerus -Hydrometra,@irked The folil4coitnigssueswere fo-.:ntdo be withinnormallimils: Brain, Spin&'/C,ord, Bo-@eNarrow, Ntirt,94%.ooathS,mall Intestine,Large Intestine, UrinaryBladder,Ao,',&,Tra,-heaT,hyroid,Pirithyro4ldP,ancreas,SalivaryBlind,Eye. --------------------------------------------------------------------------------------------- An4aailNusber: IR-4i67 Sex: Female Broup: 5) FC-14'Q300 ppe File: "Weiiz 105) Terair.,iSla,cr-Lli-,Lt Ma,-rosccp@acO'U-servatiiDns: P.&U;i-ary UrinaryBladder MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung hassa,y Gland Ovary P,irithyroid Pitu;A'6-ary SalivaryBlind Urinary Bladder -Raisedmass, !.2 es dia. -Will appearsthickened. -Corticalatrophy,bilateral,moderate -Not exas-b.-iemdi,ssing -Pelvicsinerali,.atiomni,ld -Portalsononutli&crellinfiltratem,ild Por*,iblileductproliferationm,ild NotilKytogis,mild -Vascularsioaralizations,ild Pneumonia,interstitialc,hronic,oultilocal, mild Alveolarsacrophiges,local areas,moderate Hemorrhage,local&ireas,mderate Brinulosa-m,ultiple -Not examined,missing -Tubularhyperplasia,sild -Not examined,not in plantof section -Adiinnai -Not examined,missing -Epitheliahlypirplasias,imple,diffuse,sild Hypertraphy,ouscularis,sild The follovingtissueswere foundto be withinnormallimits: Brain,SpinalCord,kne Narrow,Spleen,Heart,Stomach,Sga!l Intestine,Large Intest,.ne, Aorta, Uterus,Trachea,Thyroid,Lymph Node (sesenteric),Pancreas,Eye. ------------- - - - --------------------------------------- ------ --------------- Species: Rat Project Number: 0221CROO12 Susearized STAR Page: 139 303 SummarizedSingleTabulatedAnisalReport (continued) IndividualMacroscopicand Microscopicobservations Rikr LaboratotitItn,c. 3" FC-143:Two Year Oral Toxicity-DneogeniciSttyudy in Rats Table:2 --- - --------------------------------------------------------------------------------- AnimalNumber:IF-4668 Sax:Fesile Group: 5) FC-143300 ppe Fate:(Weeit 8!) Sacrificeidn ex'@resis P,acrosccpiOcbservations: Fitu-""-ary' M44croscap@aOcbservations: Acrenal Liver Lung Miseary Gland Parithr-oid Pituitary Spleen Thyroid Uri.-.arByladder -Enlargeddue to red Bass, I K 0.6 Cl. -Sinusaidaelctasii,cortex,mild -Nepatocytevaccolat@lerp,eripartal,moderate -Vascularsintral@azatiomni,ld Hemorrhage,local areas,a@ild -Not examined,missing -Not examined,eirsing -Adenosa -Nesesiderosism,ild 4ot tinined,missing -Not examined,missing 'ihcf.ollowingt4ssut-*serefoundto be withinnormallimits: brain,SpinalCard,Bone Narrow,Kidney,Heart,Stomach,SmallIntestine,LargeIntestine, Aorta,Uterus,Ovary,Trachea,Esophagus,LymphNode toosenteric)P,ancreas,SalivaryGland,Eye. ------------------------------------ - ------------- --- ----------------------- AnisillNumber:IR-4670 Sex:Fesi'leSroup: 5) FC-143300 pps Fate:(Yeeiz 91.)Sacrificedin extras-a's MicroscopicObservations: Pituitary Micruscop4i-6 Observations: Adrenal Kidney Liver Lung Hist,ir6y'4ard Pituitary Spleen -Raisedhemorrhagicmass,I cc dia. -Sinusaidaelctisia,cortex.unilaterals,-4.d hodullary-celh!yperplasia, -Chronicprogressivenephropathys,ild Pelvic miner&14Aza'6iomno,derate -Pigmert,Kupfercall,broom,sild -Alveolarsacrophigesf,ocal,aild Perivasculas.o-nonuclearinfiltratem,inimal -Not examined,missing -Adencoa -Nesosiderosis,@;.Id The fcllon;,ntgissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Karroo,Heart,Stomach,Small Intest4.neL,arge Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Trachea,Thyroid,ParithyroidE,sophagus, LymphNode loesenteric)P,antries,SalivaryBlind,Eye. ------ -------------------------------------------------------------------- Species:Rat Project Number: 0261CROO12 Summarized STAR Page: 140 304 SummarizedSingle TabulatedAnimalReport (continued) IndividualMacroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3N FC-14'0'T:wo Year Oral Toxicity-encogenicityStudy in Rg,tls Table: 2 --- -- --- ------------------------ -- -------------- ---- -- ------- ----- AniaalgNumber: IP,-46714 Sex: Fesilt Group: 5) FC-143 300 ppe Fate: (Weeka105)TerminalSacrifice RacrostapicObse,vilioni: Pituitary MicroscopicObservatiors: Adrer.al Esopha;us Lung Lymph Node (mesenteric) Ovary Parit,@yraid Pituitary SalivaryGland Thyroid Trachea -hisorrhagicmass, 0.9 ce dii. -Sinuso.idaelctasia,cortex,minimal -Not examiied,missing -Hemorrhage,local areas, moderate -Pigaent,brown, minimal -Tubularhyperplasiiu,nilateral,moderate -Not examined,missing -Adenova -Sialadenitisc,hronic,moderate -Not examined,missing -Not examined,missing The followingtissueswere foundto be within normallimits: Brain, Spi-,iaClo&rd, Done Narrow,Spleen,Liver, Kidney,Heart, Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,MammaryBland.Pancrlar,E,ye. ------------- --------- ----- --- Animal Number: IR-46r4 Six; Finale Group: t 5) FC-143300 ppe Fate: (Weekz 79) Sacrificedin extromis MacroscopicObservations: Pituitary Skin M@acros@.opicObservations: Adrenal Livir Lung Rassary Blind Pirathyroid Pituitary Thyroid -Largehemorrhagicmass, 1.5 x I ce dia. -Subcutaneousmasses, 1.5 1 1.5 1 1 ce, right axilla;3.5 1 3 x 2 ce leftaxilla. -Sinusoidalec,6asiac,ortex, Bild -Portalsonanijclecaerll iniiltratem,ild Portalbile ductproliferatiormii,ld -Vascularsintralizatim,sild -Adenocarcinosa salactacell Lobularhyperplasia,moderate One of the grosslydescribedusses was in area c4 galactocoilsimd lobuiarhyperplasia. -No" examined,missing -Adenala -Not eKae4aned,missing The followingtissueswere foundto be withinnormal limits: Brain,S;inalCard, Owe Narrow,Sploor,K,idney,Heart,Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary, Trachea, Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryGland,Eye. Species: RAI, Project Number: 02BICRO12 Sumrized STAR Page: 141 305 SummarizedSingleTabulatedAnimalReport& (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Too Year Oral Tox@acity-OncogeniciSttyudy in Rats Table: ------------------------------------------------------------------------------------- Animal Number: IR-4675 Sex: Female 6roup: 5) FC-143300 ppe Fate: (Weekz105)TerminalSacrifice MicroscopicObservations: Lung Kidney MicroscopicObservat4lons: A.0renal c.sephagus Heart Kidney Liver Lung Pirathyroid Pituitary -Apparentareas of consolidation. -Somewhatpale and pillted. -Sinusaidilectisia,cortiz,moderate Corticalva,,uolitiomni,ld -Not examined,missing -Myocarditis,chronicnonsuppurit4ave, localareas,sild -Chronic progressivenechropa*@hy,moderate -Portalsononucleiicrellinfiltratem,ild Negalacytosis,minimal -Vascularmineralizationm,ild 6rinulosa,diffuse,marked Largearea of granulomawith many giant cells. Few fragments.oforeignmaterial present. -Not examined,not in plane of section -Aden*@& The followingtissueswere found to be withinnormallimits: Brair!,SpinalCc,-d,Bone Narrow,Spleen,Stomach,Small Intestine,Large Intestine, UrinaryB;adder,Aorta,Uterus,Ovary,Pamary Bland,Trachea,Thyroid,Lymph Made (sesenteric), Pancreas,SalivaryBlind, Eye. ---------------------------------------------------------------------------------------- Animal Nueber: IR-4677 Sex: Feeale Group: t 0.)FC-147W300 ppe Fate: (Weekx1L@)TerminalSacrifice Rac,,osr.o;'OAbcservations: HasetryBlind -Mass,2 x 1.5 ce, in lefl,alilla., oultilobularmass,6.5 1 5.5 1 2 ce, in perinealarea. MicroscopicObservations: Adrenal -Corticalvicualations,ild Esophagus Kidney Sinuscidalectisia,cortex,aild Not examined,missing -Pigeent,conv.tub. epithelium,braiii, minimal Liver -Partil sonanuclearcell -anf44l'urimtoed,erate Portalbiltductproliferationm,oderate Regalacytosis,minimal Lung -Vasculara-Aneralizationm,ild ---- ------------ --- ------------------------------------------------ - Species: Rat Project Number: 0261CROOIAI& Summarized STAR Page: 142 306 SultarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand Microscopicobservations Riker LaboratoriesI,nc. 3H FC-143:Two Year Oral Toxicity-Oncogeni-,;S4ttuydy in Rits Table:2 -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Anisa'ANumber: IR-4677 Sex:Female Broup: 5) FC-!43300 pps Fate: (Weeks105)TerminalSacrifice MicroscopiOcbservations(continued): Lyt;@W,aie (aesentericfHastaryBlind Ovary Pituitary -ginusoidalectasia,moderate 4ibroadenoma Fibroadenosa -Tubularadenosa,unilateral -Adenosa The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard, BoneNarrow,Spleen,Heart,Stomach,StallIntestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Trachea,Thyroid,ParithyroidP,ancreas,SalivaryBland,Eye. ------------ ---------------------------- --- -- -------------------------------- AnisilNumber:IR-4678 Box: Female Group: 1 5) FC-143300 pps Fa'6e:lkeekz 49) Sacrificeidn extresis MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Parathyroid Pituitary Spleen UrinaryBladder -Enlargeddue to eass,I x 0.7 ca. -Sinusoidaalctasia,cortex,o-,Id -Pelvicmiwalizal@ion,mild -Portalsonmuclearcell-infiltratmei,ld Nepatocytovacuclationl,ocalareas,mild -Vasculasriniiralizatiomni,ld Perivasculbmaornuclear infiltratem,ild Hemorrhage,localareas, moderate -Notexamined,not in plantof section -Adenoma -Htaosiderosism,ild -Not examined,missing The folalaomitnigssues*erefoundto be withinnormallimits: Brain,Sp4nalCard,Bane Marro*,Heart,Stomach,Small IntestineL,arge IntestineA,orta, Uterus,Ovary,IU*eary61&rd,Trachea,Thyroid,Esophagus,LymphNode (sesenterictP,ancreas, Sa',iyary61a,",dE,ye. - ---- - --- ------------------------------ ---------------------------- Animal Number: IR-4679 Sex: Fesile Brou;: t 5)-FC-14"3@00 pps Fate:(Weeks105)TerminalSacrifice MacroscopicObservations: Pituitary Mammary Bland - ---------- -Raisedhemorrhagicmass,0.5 ca dia. -Nodularmass,I ca dii.,in leftalillag, largemass,5 1 5 ca, in right ingainalarea. Species:Rat Project Nuebtr: 0281CROO12 Smarized STAR Page: 143 307 SumairiziiSdingleTabulatedAnimalReport (continued) IndividualMicroscopicand Hicrostgoicobservations Riker Laboratories,Inc. 3m FC-143:Two Year Oral Taxici'Ly-OncoglnicSituydyin Rats Table:2 ---------------- --- ---- ------ - --- ------------------- ------ -------------AnimalNueber: IR-4679 Six: Feea'atGroup: 5) FC-143300 ppe Fate: (weeks101.T)erminalSacrifice 4icroscapiOcbservation(scontinued): Adrer.al Esophagus Kidney Liver Lung Haaaary Sla-.i@ Ovary P;tt.,itiry Thy,-G@.1 U.',-erus -Cirticalvacuelationm,oderate Sinuscidalectasia,cortex,moderate Nodularhyperplasiac,ortex,focal,moderate -Not examined,missing -Chronicprogressivenephropathy,marked -Portalbile ductproliferat4&omri.l,d -Pneumoniai,nterstitialc,hron@4cf,ocal, minimal A!veolareacrophagesf,ocal,aild Perivasculasrmanu,-Ieairnfiltratem,ild Hemorrhage,local areas,moderate-Fibroadenoma -Tubularhyperplasiab,ilaterals,ild -Adenuma -Ultimcbrinch-caylst -Cysticglands,minimal The following'.issuewserefoundto be withinnormallimits: Bra@,nS,;-InaClard,Beie Narrow,Spleen,Heart,Stomach,Small Intestine,LargeIntestine, Ur'snarByiladlueAra,rti,Trachei,PirathyraidL,ymphNode (sezenteric)P,ancreas,SalivaryGland, EyE. --------------------- ------------ - --- ---------------------- AnimalNister:IR-4690 Six:Female Groq: 51 FE-143 300 ppe Fite: (Notiz104)FoundDead MicroscopicObservations: Rameary Gland Pituitary Liver MicroscopicObservations: Adrenal Eye Heart Kidney Large Intestine Liver Lung Lymph Node (sesonter4.c) -Largemass,9 1 9 1 3.5 ce, in lt4'6i-ngi@Anal area. Masshad necrotic, hemorrhagicsurface. -Darklesion,0.4 ca dia. -Pale -Sinusaid;elctasia,cortex,mild -Not examined,missing Ayocarditis,chronicnonsuppurative, localareas,mild -Pelvicsintraliziilkimoin,imal -Not examined,missing -NKrosis,contrilobularm,arked -Vasculasrintralizatiosni,ld exisioed,missing Species:Rat Proje,-tNumber: 0281CROO12 Susarized STAR Page: 144 308 SummarizedSingle TabulatidAnimalReport (Continued) IndividualMacroscopicand Microscopicobservations RikerLaboralkoriesI,nc. 3N FC-143:Two Year Oral Toxicity-Oncagvnicitsytudy in Rats Table: 2 ------------- ----------------------- -------- - - ----- --- ---------- Animal Number: 1R-4680 Sex: Famile Group: 5) FC-143 300 ppe Fate: (beeks104) Found Dead MicroscopicObservationsicantiiiued): HiceiryBland Ovary Parathyroid pituitary Small In'lestint L'terus -L-yaphan;iosarco2i Largewell differentiatetdutorwith numerous twerate to largesi-,tspicestontainirifgew lymphocytes. -Tubularhyperplasia,moderate -Net e%igined,not in plantof section -Adenoiia -Not examined,missing -KC46examined, lissin; The follov4@n;'%.issuewsere found to be within norna! lis4@ts: Brai,-,S,pina!Card, Done Narrow,Spleen,Stomach,Uriniryflidder,Aorta,Trachea,Thy,aid, Esophagus,Pa-,creas,SalivaryBland. - ------------------------------------------------------------------------------------------ Ar.i4alNLBter: IR-4681 Sex: Fesile Group: 5) FC-143 300 ppe Fa4Le:(Week= 97) Sicri4icedin extromis MicroscopicObservit-.r,-s: Pituitary MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Ovary Pancreas Parathyroid Pituitary Spla.len -Hemorrhagicmass, 1.2 ce dia. -Siousaidalectisia,cortex,moderate -Not examined,missing -Pelvicsintralitationm,inimal Pyelitis,acute,urilateral,moderate -kpitacytivacuolitiono,ultifacils,ild -Vascularsineralizations,ild Alveolareacrophages,+eta,, minimal Puivascularsonanucltiirnfiltratsm,inimal Hemorrhage,focal, mild -T-ibulahryperplasia,moderate -Acinaratrophy,mild -Net examined,not in plane of section -Adencti -@Omos@4derosis,aild The followingtissueswere foundto be withinnormal limits: Brain,SpinalCord,lone Narrow,Heart,Stomach,Still Intestine,Large Intestine, UrinaryBladder,Aorta,Uterus,MammaryBland, Trachea,Thyroid,Lymph Node (sesenteric), SalivaryBland, Eye. -------------- - ---- ----- ---- -------------- - -- Species: Rat Project*A6er,.OnICM12 Sumarizid STU Page: 145 309 Suuarized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FC-143:Two Year Or&! Toxicity-oncogeniciSttyudyin Rats -- ------------------------------- -- --------- -- ---- --- -- --- -Animal Number:IR-4682 Six:Female 6roup: 5) FC-143300 pps Fate: (Weekz 94) FoundDead Table:2 MicroscopicObservations: Maemary 61and Micresf,apiOcbservations: Adrenal Esophagus Eye Large Intestine Lur.g LymphNode (sesenteric) r,iseary6'iand ovary Pancreas Pi,at,@yroid Pituitary SalivarySlird saallIntestine Stomach Thyroid UrinaryBladder Uterus -LargeBu!tilabulamriss,11 1 9 x 6 ce, in leftaxilla. -Sinusaidalectas-.ic,arl,exm,arked -Not examined,missing -Not examined,missing -Not examined,missing -Vasculamrintri'Lizatismi,ld Alveolarmacrophagiso,ultifocals,ild -Not exasintd,missing -Fibroadenosa -Not examined,liss@ang -Not examined,missing -Not examined,missing -Adencea -Not examined, missing -Not exasiniidm,issing -Not examined, missing -Not examined, missing -Not examined,missing -Not examined, aissing The 4cl'joocitnigssueswerefoundto be withinnormallimits: Brain,Sp@.niClaard,Bone Narrow,Spleen,Liver,Kidney,Heart,Aorta,Trachea. ----------------------------- ---- An4.aalNumber: IR-46r4 Six: Female Group: 1 5) FC-143300 ppe Fate:(Meek=105)TerminalSacrifice MatroicapicObservations: Pituitary MicroscopicObservations: Adrenal Esophagus Liver Lung ovary Parithyroid Pituitary - -- --- - -- - -Miss,0.5 ce dia. -Sinuscidaelctasia,cortiz,moderate Adenoma,cortical,unilateral -Not examined,missing -#art&!sononucleacrell infiltratem,ild -Granulomal,Ulti4K&I,sild Foreignmaterialin some granulomas. Hemorrhagel,ocalareas,sild -Tubularhyperplasiab,ilaterale,adtrate -Notexamined,not in plantof section -Adenosa Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 146 310 Sumair4lzeSdingleTabulatedAnimalReport (COAtiftuld) individualna,.roscapiacnd MicroscopicObservations RikerLaboratoriesJ,rc. SM FC-14'Tvo:o YearOF&I Tosicity-OncogenicSituydyin Rats -- ----------------Ar.iialNaumber:IR-466'j Sex:Fisall Group:( 5) FC-143300 pps Fate: (Neekz10.5T)erminalSacrifice Table:2 MicroscopicObservationsicantinued): The folloningtissueswirefoundto be withinnormallimits: Brain,SpinalCard,Done Narrow,Spleen,Kidney,Heart,Stomach,Small Intestine, Large In'@estineU,rinaryBladder,Aarti,Uterus,MammaryGland,Trachei,ThyrG4,d, LymphNode (Resenteric)P,ancreas,Salivarygland,Eye. ------------------------------------------------------------------- --- AnitilNumber:IR-4664 Sex:Fesile Group: 5) FC-143300 pps Fate: (Neekz10'))Found Dead PicrostepicObservations: Fitui,6iry MicroscopicObservations: Adrenal Aorta Esophagus Lung LymphNode (mosenteric) HassiryGland Ovary Paratt,yroid Pituil.ary SalivaryGland Thyroid Trachea UnidentifieTdissue -Raised,hemorrhagic0,.1 ce dia. -Not examined,missing -Not examined,missin; -kt examined,missing. -Vascularsinerilizatiorm,i,ld -Not examined,missing -Nct examined,missing -Tubularhyperplasia,moderate -Nateximin",missing -Adenosa -Not examined,missing -Not examined,missing -Not examined,missing -Lipass Largenecrotictumorc4 id4ap3steissue. Site unspecified. The followingtissues*artfoundto be withinnormallimits: Brain,SpinalCc-d,tone Narrow,Spleen,Liver,Kidney,Heart,Stomach,Small Intestine, Large InI.estineD,r@&narByladder,Uterus,Pancreas,Eye. --- --------------------------------------- - ---- ------------------ -- ---- ------------- Animal Number: IR-46810 Sex: Female Group: 5) FC-143 300 ppe Filue:lkeeka75) Sacrificeidn extresis MacroscopicObservations: Hiseary Gland -Largemiss,15 x 9 x 4 ce, somemil,fiitre and oult-lobular. Adrenal -Both@peared enlargedwithdark foci. MicroscopicObservations: Adrenal -Sinusaidielctisia,tortti,moderate - - --------------------------------------- Species:Rat Project Number: 0281CROO12 Sumrized STAN Page: 147 3 11 SdonarizodSingleTabulatedAnimalReport (continued) IndividualMacroscopic&Rd Nicroscopiro.bservations RikerLaboratoriesI,nc. 3m FC-143:Too Year Oral Toxicity-ontoggniciSttyudy in Rats --------------------- Table:2 - ------------------ APisa'tNumber:IR-4685 Sex: Female Broup: 5) FC-143300 ppe Fate:(Wetka75)Sacrificeidn extresis MicroscopiOcbservations(continued): Esuphigui Kidney Liver Lur.g Massiry Slaand SalivaryBland Spleen -Not examined,missing -Pelvics@Ineralizatiomna,rked -Mcrosis,sultifocals,ild Heastepo-,*eseixst,rasidullaryo,odera'6e -Vasculasrinerilizatioani,ld Alveolarsicrophigesf,oci.,minimal Hemorrhage,local areas,soderal6t -Fibraidenaga -Not examined,missing -Hematopciesise,xtrasedullaryi,ncreased, o;.Id The followingtissueswerefoundto be oithinnormallimits: Brain,SpinalCord,Bare Narrow,Heart,Stomach,Small IntestineL,arge Intestine, UriraryBladder,@arti,Lterus,Ovary,Pituitary,Trachea,Thyroid,Parathyroid, LyapflMiode (sesenteric)F,increas,Eye. ------------------------------------ -------- ----------- --- - -------------- AnisalNumber: IR-4696 Sex:Fesait Srotip:t 5) FC-14'3400 pps Fate: (Week=105)TerminalSicrii;.te MicroscopicObservatiorls: P@atui'Lir-i tiagiryBlind Liver MicroscopicObservations: Adrenal Esop@.a;us Liver -Smallhemorrhagi*cass,0.3 ce dii. -Largesultilabulamrass,10 1 7 x 4 ce, in rightaxilla, -Kass,5 r 3 ca,in rightlilueral -Si.-.uscidea-l.tisiie,r,-'@ex, -MOILeragire.1,missing 4ortalb.ie '6ur4; -A* Ntarrllia;el,ocalareas, s4A*@d -Fi.lroade!,.osi .6 .6 -Aetnala .::i t4ssuesmerefoup,t.c' ',.iesithinroro&'Aliaits: firi@rS,pin&!Card,Date Hirrou,S;Ieen,Kidney,Heart, StallIn'test4ne, Large ln@.es4@inUtr,iraryBladder,Aorta,Uterus,Ovary,Tri:tei,Thyroid,farithyroid, LympllN!ode isesenluer;&cP)a,ncreas,Sal@*varygia-id,EVE. ------------------------------------------------------------------ -------------------- Spec4Les:Rit Proje,,"N6u24,a-',: 028!:R6A.11, Sussar'&zedSTAF Page: 14E 3 12 Susearize.,SingleTabulatedAnigs!Report #,Co.-,41inued) IndividualMicroscop;.ac.-.Pdicrasco;i.O-bservations Riker '@Aborilt,,DIrn'ce.s,i4 FC-141@:yo.-year Oral '#rxic4lty-C.-itoge-Sttiucdiytiyn Rats Tablf: -- ----------------------------------------------------------------------------------- Ani.siNtuater:1;-4688 Six: Fesile Group: 5) FC-14,3v03 ppt (4eekz 10e@,Tlfra",-,al, Mar.resce;@iCp'.U-servi'6ions: C*;Al@;tary M;croscep4:Obse"a"-;Aars: Adrenal @eart K;&d,-.Ev La-geIntestine F.amr.iriyi.a;ilw Ovary P@itu;ata-Y Spleen - -Itiss0,.9ce dis. -Sinusaidialcltasia,cortex,mild -Myocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivneephropathya,ild -Nolatodiasisc,olon -Kc'6 examined, missing -Tubularhyperplasia,moderate -Adencea -Hemosiderosiss,ild The followingtissuesmere4ourdto be withinnormallimits: Bra;An,Sp'AnilCc-d, Done Narrow.,Liver,Lung,Stomach,Small IntestineU,rinaryBladde-,Aorti, L!terusT,ricleA,Thyroid,PiratlyraidE,sophagus,LyaphNode (sestr@tericP)a,ntrits, SalivarySland,Eye. -- --------------------------------------------- -------- - -- --- ------------- AnisalNumber:IR-4690 Six:Finale Group: 5) FE-143300 ppe Fite:(Week=105)Teraina!Sacrifice Racresp.opiOcbservations: Mi-.roscopiOcbservations: AdrEnal Kidney Liver Lun; LymphNode (sesenteric) Parathyroid Thyroid -No visiblelesions. -Sinusaidaelctasis,cortex,unilateral, marked * -Chronicprogressivenophropithy,a;ald -Nepatocytveacualitions,ultifocala,;sld -Vascularmineralizil.iosni,l.d Pneumonia,interstitialc,hronic,oulti4ocal, mild Alviiolaeracrophagesl,ocalareas,mild -P4goont,brown,mild Not exia-a*nerditotin plantof section -Ult-Amobranchicaylst Thefollomin;tissues*erefounutlo be withinnormallimits: Brain,SpinalCard,Bone Narrow,Splear,H,eart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,AorluaU,terus,Oviry,MammaryBlind,Pituitary,Trathei,Esophagus, SalivaryBlind,Eyt,.Pancreas. --- ------------ ------------------------- ------------- - ------- - - --- ----- Species:Rat Project kaber: 0281CROO12 Sumarized STAR Pago: 149 313 Sumarized SingleTabulitilAdnimalReport (Ccntinutd) IndividualMacroscopicand MicroscopiOcbWvatims Riker LaboratoriesI,nc. 3H FC-1143T:od Year Oral Toxicity-ontageniciSttyudyin Rats fable: --------------------------------------- -- -------------- --- ------------ ----------- Number: IR-4691 Be%: Female Group: 5) FC-14'j300 ppe Fate: (Weeka100)Sacrificedin extregis MacroscopicObservations: Liver Adrenal M;Icresco;icObservat4&o,-.s: Adrenal Kidney 14.iver Lu.,g ;ircreas Sp',eer, Thyroid V@Anary Bladder -A@pearen!argelmuitt multiplepile foci in all I.Obes. -Left adreralappearsenlarged. -Ilcrlkicvailcuo'Aatiorl.o,cal areas,s@'d Sinuscidalectasia,cortex,unilateral,, marked -Myocarditis,chronicnonsuppurative, oultifecal,a-ald -Chronicprogressivenophropithy,siniaal Proteinresorptiondroplets,tubular,marked -Maligrintlymphosa,histiocytic -Vascularsintralizationm,ild Malignantlysphosa,histiocyti,. Hemorrhage,local areas,sild -Ed@&&,intersititials,ederate -RessLopo@esis,extramedulalary,iric-eased, aoderate -Edina, subsucdsal,moderate -HyperplasiaC, till,focal,mild -Malignantlympholl,h44stiocy,,4ic The tissues more found to be v@t.@innormal limits: Brain, Spinal Cord,Bone Karroo, StallI;testint,Large Iftles?lint, Uterus, Ovary, Mazoary Oltand,P-LtL,4t&ryT,rachea, Parithyraid,Esophagus,Lyif#pNhodi (sesenter4@c), SalivaryGland,Eye. --- - ---- --------------------------------------------------------------------------------- Anima'aNumber: IP-469.1 Sex: Female Grw4p: 1 5) FC-143 300 p;e Fate: (Week*105)TerairalSacrifice Microsccp4&cOtservations: Pituitary -Dart raisedlesion,0.3 co d-Aa. MicroscopicObservationr,: Adrenal -Sinuicidilectisia,cortex.m,arked Kidney -Pelvicsineralizationa,ild Liver Lung -4pitacyto vacualation,multifecal,mi'4d -Pneumonia,interstitialc,hronic,localareas, mild Alveolarsacrop.@agesl,ocal areas,sild Perivasculawrnuouclear infiltrates,ild Pituitary -Adencea -------------------- ----------------------------------------- ---- ------ --- ------- Species: Rat Project Number: 02EI'.RO012 Summarized SRAR Page: 150 314 SuanariiiiSdingleTabulatedAnisalRepcrt (continued) IndividualMacroscopicInd Hicroscoic Observations RikerLitaritatlitI,fit.'.IN FC-143:Two Year Oral Toxicity-encogen;aciStyudyin Rats Table:2 ------------------------------------------------------------------------ ---------AnisalNumber:JR-4693 Sex: Fesile Group: 1 5) FC-14'3v0@0 ppe Fite: (Weekz105)TerminalSacrifice MicroscopiOcbservations(continued): The fcil@ow;itnigssutswere foundto be withinnormallimits: Bra@,r,S,pinilCord,Bone Marro*,Spleen,Heart,Stomach,Stall IntestineL,arge Intestine, Llrir.aBrly;dder,AcrluaU,terus,Ovary,Mammary$land,Trachea,Thyroid,Parathyraid,Esophagus, Lyip.'M,C,4A(Esesenteric)P,ancreas,SalivaryBland,Eye. --------------------------------------------------------------------------------------------AnisalNinber:IR-4694 Sex: Female Group: 5) FC-143300 ppe Fite:(WeekaIOl)TerminalSacrifice MicroscopicObservations: Pituitary Mammary Gland ?.i-.ros-,Dp'AOcbservations: Adrei-.al Kidney hissiryBl,ard Ovary Par,ithyro4ad Pituitar,i Spleen -Raisedmass,1.2 ce dig. -Smallnodularlesion,0.8to dia.,in right axilla;possiblseilkcyst. -Sinusoidaelctasia,cortex,marked -Chronicprogressivneophropiithgyi,ld Pelvic sintrali,-atiomri,n,imal -Alveolarascrophageso,ultifocala.-A.d -Fibraidenm -Cyst,unilateral -Notexal4ned,not in planeof section -Adeposi -Hisesideres4,sm,oderate The followingtissueswerefoundtc be withipiorsillimits: Brain,Sp;nalC,ord,Bone Narrow,Liver,Heart,Stosac@,Small IntestineL,argeIntestine, Urip,arByaidder,Aar4,iU,terus,Trachea,Thyroid,Esophagus,LymphNode (asenteric),Pancreas, Sal-ivarBylind,Eye. ---------------------------------------------- ----------- -- ---------- ---------------- Anioal Number:IP-4695 Sex: Fmale Group: 5) FC-14.r300 ppe Fite:(Week=105)TerminalSacrifice MacroscopicObservations: Pituitary Raseary Bland Liver MicroscopicObservations: Adrenal Kidney -Hemorrhagicmass,0.8 co dia. -Lobul.acrystic&ass,4.r., 3 1 2 to,in left axilla. -"ass,3.5 x 3 1 2 to, in sedianlobe. -Sinusaidaelctasia,cortex,unilateral, @irked -Chronicprogressivaetoropithy,mild Pelvicsintralizatiomni,ld Species:Rat Project Number: 0281CROO12 Summarized STU Page: 151 315 SUMari2ed SingleTabu&latedAnimalReport (conta 4nued) IndividualNACrOsr-OPiAcnd microscopicobservations RikerLaboratoriesl,ot. 3H FC-143:Tic YearOral Toxicity-encoge.-tiSctiutdyy in Rats Table:2 -------------------------------------------------------------------------------------- AnisalNumber:IR-4695 Sex: Female Sroup: 5) FC-147#300 pps Fate: (Oeekm105)TerminalSacrifice Microscop@AOcbse!,vat;ao(ncsontinued): Liver Lur,c P.ageary61ind Pituil.ary Uterus -PvtaAlsononucleacrellinfiltrates,Iild Hepitacytevacualationo,ultifocalG,ild Hyperplasticnodule Large'losiownithextensivecystaid degeneratiownithinnodule. -Perivascu'Lcaorneruc!eairnfiltrates,itima'-. -Fibrt)adenama Adenccarcinosi AdenocarcinoBa&rises in fibroadenona. -Adenou -Cysticglands,mild The followingt4&ssue*sere 4oundto be withinnormallimits: Brain,Sp4,@-Ctoar'da,lone Narrow,Spleen,lbirt,Stomach,Small Intestine,Largelntestire, Ur;ina.l-iyad,.IeAro,rta,Ovary,Trachea,Thyroid,Parathyroid,Esophagus, LymphNode (misititericP)a,ncreas,Salivarygland,Eye. ------------------------ -- --------- .4nimilNsumber: IR-4696 Sex:Fesile Brouq: 5) FC-143300 ppi Fate: (Wee@Kc105)TerminalSacrifice macroscopicObservations: Mammary gland LymphNode (iketenteric) Hicrosc,,piOcbservations: Adrenal Kidney Liver Lung LymphNode (sesenteric) Ragery 61and -Labularmass,5.5 x 4.5 1 16.!ce, left axilla;oultilabulalrass, 5.5 s A 1 2 ce, in porinealand leftinguinal area. -Largeand cystic. -Sinitscidealctasia,cortex,sild -Chronicprogressiveniiphropathys,ild -Repatocyttalterationv,acrolated, Irocaa,reas,sild Regilocytosism,inimal Hopitocytoalteratiorb.a,sophilic4,ocal, sild -Perivas,-ulmaornucleir infiltrates,in4.aal Neeorrhagel,ocalareas,Bild Branulosal,ocalareas,sild -Sinusoidalect&sia,marked 6r&nulosa,mosinte-y -FibrDadencel Adenocartinosa - ----------- Species:Rat ProjectNumber:031LItOO12 Summarized STAR Page: 152 316 Suourized SingIL,TabulatedAnimalReport (continued) IndividualMacroscopicAnd MicroscopicObservations RikerLaboratoriesI,nc. 3" FC-143: Two Year Oral Toxic@Aty-oncogLn;citSytudy ir Rats Table: 2 ----------------------------------------------------------------------------------------------- An;AailNi;aber:IR-4696 Sex: Female Group: ( 5) FC-1474300 ppe Fate: (Weeks105) TerminalSacrifice Microsco;icObservations(continued): ova@y Pituitary Sia'A@I4ntestine T.hyrr,'4d -Cyst,unilateral -Adencea -Granuloma,sesentery -Hyperplasai,C cel.l.focal, o4.1d T'l,feollowingtissueswere foundto be withinnormallimits: Brain,Spinallord, ione Narrow,Spleen,Heart,Stomach,Large Intestine,UrinaryBladder, Aorta,Uterus. ,T.ra,..ehl, PIra,lbyraid,Esophagus,Pancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------------- Animal hur.Der:IR-4697 Six: Female Group: 51 FC-14'@o300 ppe File: (keekx105) TerminalSacrifice Microscopic 01.,serval.ions: HicrL,sccpiOcbservations: Adrenal K4,dneV Lung F.4u;&Ir A, 46 Thyroid ul6fru--- -No visiblelesions. -Sinusaida,4ectasia,cortex, moderate -Hydronephrosisu,nilateral -Vasculars4Anerilizat;&os.i-lid, fer@.vis,-ulsaornonucleiiirnfiltrate,s;&Id -AdE.-ioca -Hyperplas-laC,cell, facaa,si!Ad -Cysticglands,moderate The fellov;ngtissueswere found to be withinnormal limits: Sp;;nalCord, figneNarrow,Spleen,Liver,Hear'.,Stomach,Small Intestine, Large Intestine,UrinaryBladder, Aorta, Ovary, MammaryGland,Trachea, Parathyraid,Esophagus, Lys;h Nowle(sesenter-.tlP,ancreas,SalivarySland,Eye. ------------------------------------------------------------------------------------------ Ar.iaalN&ual@,er:IR-46q? Sex: Female Group: 5) FC-143 300 ppe Fate: ikeeks105) Teraina]Sacrifice Ma.,roscap,&O*bcservations: Pitti4atary Raseary Gland -Mass,0.5 ce dia. -Mass,4 x 3.5 1 Z ce, leftinguinal. MicroscopicObservations: Kidney Liver -Chronicprogressivenephropathy,milad Pelvicmineri'sizitiosni,ld -Partilsaononuclearcall infiltrate,minimal Kepatocytevicuclationo,ultifkal,mild Regalacytosis,minimal Lung -VascularBinerilizations,ild Perivisculasronenuclearinfiltrate,mild ------------------------------ ---------- ----------- ----------------- Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 153 3 17 Suseari2ldSingleTabulatedAnimalReport(continued) IndividualMicroscopicand HicrosropicObservations RikerLaboratoriesI,nc. 3N FC-14")T:wo Year OralToxicity-OneogenicitSytudyin Rats Table:2 ---------------------------------------------------------------------------------- Animal Number:IR-4696 Sn: Fessit Group: 5) FC-14.'3%00 ppe Fate: (Weeka105)TerminalSicrifice MicroscopiOcbservation(stantinued): Hastary Gland ovary Pitu;tary -Ftbroadencei -Cyst,ur4.ilateral Tubularhyperplasia,moderate -Adencai The iollou4lnt;;.Assuemsere foundto be withinnormallimits: Brain, SpiralCa.-?-dB,oneNarrow,Spleen,Heart,Stoaa,,tS.m,all Intest4antL,arge Intestine, Ur;anarBylid4@erA,crluiV,erus, Tra-,."iA,drenal,T,hroid, ParatSyraidE,sophagus, Lyt;h N:,W'ieBesen4Ler4aPca,n'c,reas,SalivaryBlind,Eye. - --------------------------------- - -- -- --- ---------- -- ----------------------- AnisalN.uabfr:IF-4700 Sol:Feeale Sroup: 5) FC-143300 ppo Fite:!,Week=96) Sacrificedin ex,4resis MicroscopicObservations: Kissary Gland Heart Adrenal Kidney MicroscopicObservations: Adrenal Acrti Heart Kidney Lung Lymph Node (sesenteric) Mammary 6'&and ovary Parathyroid Small Intestine Stomach Thyroid -Hass,3 x 2 co,in left&till&, -Appearspossiblyenlarged. -Rightadrenilappearsenlarged. -Paleand pitted. -Sinusaidatlctasia,cortex,unilateral, marked Corticaldegenerationu,nilateralm.a,rked Cortical&trophy,unilateralm,oderate -Not examined,missing -*yocardiaftibrosisl,ocalareas,sild -Chronicprogressivenophropithy,marked -Pneumoniai,nterstitialc,hronic,diffuse, marked -Not examined,missing -Fibr"dono" -Tubularhyperplasiam,arked -Not examined,missing -Edema,laminapro;ria, jejuiums,ild -Edna, subsucesil,moderate -Not examined,missing The followingtissuesserefoundto be withinnormallimits: Brain,SpinalCrrd,BoneNarrow,Spleen,Liver,LargeIntestineU,rinarygladder,Uterus, Pituitary,Trar.heaE,sophagus,Pancreas,SalivaryGland,Eye. --------------- - - - - ------------------------ ------------------- ------- Species:Ral, ProjeclkNumber: 0281CROO12 Sumarized STU Page: 154 318 SummarizSeidnglTeabulateAdnimalReport(continued) IndividuiiM!acroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Too Year Oral Toxicity-DncoggnicitSytudy in Rats --------------------------- -- Table: 2 - ---------------------------- ----------- Animil Number: IR-4701 Sax: Fesa'Ac Group: 5) FC-14! 301%p'pe Fate: (Week=105) TerminalSacrifice MicroscopicObservations: Pituitary Hicrosco;icObservations: Adrenal Liver Lur.g Pa-ithyraid P4.tuitary -Hemorrhagicmass, 0.5 ce dii. -Sinusaidielctisia,cortex,sild -Hapatocytovacualition,si.-'4tifccsailn,isil Regalacytosis,minimal -Pneumonia,interstitial&c,hronic,local,miad Alveolarmacrophages,ic.-al,sild -Nct eximined,not in plaineof section -AdenDea The followingtissueswere foundto be within normallimits: Bri4a,-S.p,inal Card,Sort Narrow, Sp!een, Kidney, Heart.,Stomach,Small Intes,64ne, Large Intestine,UriniryB'AidderA,arti,Uttrus,Ovary,HasearyBland,Trachea,Thyroid, Esophagus,Lymph Node teesenteric),Pancreas,SalivaryBlind, Eye. ------------------------------------ ---- - ------------------------------ Animil Number: IR-4702 Sex: Femile Broup: 5) FC-143 300 ppe Fa'ke: (ketkr 87) Sacrificedin extrimis MicroscopicObservatiois: Pituitary Naspary Eland Liver Hicrosco;icObservations: Esophi;us P,eart Kidney Liver Lung Kaseary Blind Ovary Pancreas Pituitary -Reddishaass, 1.2 s 0.8 cc. -Labulallemdass,3 1 2 x I ca, in left alillaryregion. -Nottltdand slightlypile. -Not Ptained, missing -Myocard;,tisc,hronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropithy,sinizil Pelvicmineralizationm,inimal Pyelitis,acute,unilaterals,ild -Hepatocyteva,-.uolatiopne,ripartal,moderate -Vascularmineralizations,ild Hemorrhage,oultifocal,mild -Adenacircinm -;Tubularhyperplasia,moderate -Not examined,sis&4ng -Admou The followingtissuesare foundto be withinnormallimits: Brain,SpinalCord,bpi Karroo,Splm, Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Trachea,Adrenal,Thyroid,Parathyroid,Lymph Node (sesenteric), SalivaryBland,Eye. species:Rat Project Number: 0291CROO12 Summarized STAP Page: 15'w 3 19 SummarizedSingleTabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Tatici.ty-onc:)geniSctiutdyy in Rats -- - -------------------------------- ------------------ - Animal Number:IR-470: Sex: Female Group: 5) FC-143300 ppe Fate: (Week=IOL4)Terai,-iSaa'crifice Table: MacroscopicObservaticns: MicroscopicObserva'6icns: Adreial Escobagus Heart Kidney Liver Lung Wase,tryEl.and Pancreas Pituitary -Lobularmass,3 1 2 ce, in perintalarea. -Sinusaidaelctisia,cortex,marked -Not examined,missing -Hyacarditisc,hronicnonsuppurative, oultifoca,a4i,ld -Chronicprogressivneephropithys,i.ld -Repatocytvoacucl&tiono,ultifocalm,inisil kpitocytoalterationv,acuolaiteodu,'A+ifocal, sild -Pneumoniai,nterstitialc,hronic,locaaareas, sild Alveolarsacrophagestlocal areas,@;Ald -Labularhyperplisis -*yperplasiias,letcell,sild -Adenoma The followingtissueswerefoundtc be *ithionormallimits: Bra:&n.S,pinalCord,Bo,^.Nearrow,Spleen,Stomach,BeallIntestine,LargeIntestine, UrinaryBladder,Aorta,Uteri;sO,vary,Trachea,Thyroid,Paratbraid,LymphNcde ("St.-Ittric), SalivaryBland,Eye. -------------------------------------------------------------------------------------- Anizal Nue6ver:'tR-4705 Sex: Female Broup: 5) FC-143300 pps Fate:(Weeiz 62) FoundDead Macrosco;icObservations: Pi'L,u'.tary F.icroscapiO.b-servations: Esophagus Eye Heart Liver Lung SalivaryBland UrinaryBladder -Two smallhemorrhagiclesionsapproximately 0.1 CA dia. -Not examined,litsing -Not examined,aissing -Hyacarditisc,hronicnonsuppuritive, oultifocals.i,ld -kpatocytevacualitiono,ultifecalm,ild Negilo.-ytosimii,nimal -Vasculasrintralizatiosni,ld -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: SpinalCard,kne Narrow,Stomach,SmallIntestineL,argeIntestine,Aorta,Uterus,Ovary, Ramry Bland,PituitaryT,rachea,Adrenal,Thyroid,ParathyroidL,ymphNode (aesenttric), --- -- ---------- Species:Rat Project Number: 0281CROO12 6m arized STAR Page: 156 320 SU&GirizedSingle TabulatedAnimal Report (continued) IndividualNacroscapitand MicroscopicObservations Riker LaboratoriesI,nc. 3M FC-14'vT:wo year Oral Toxicity-oncoggniciSttyudyin Rats ----------- - ---------------- ------------------------------- --- ---------- Animal Number: JR-4705 Six:Female Sroup:( 5) FC-143300 ppe Fal%,e(:Neeka 12) Found Dead MicroscopiOcbservatior(scontinued): The tissueswere foundto be withinnormalJig-4ts(con46inuedi: Pincreis,Brain,Sp:een.K,idney. --------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Sustrized STAR Page:157 321 SummarizedSingle TabulatedAnimal Report IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3m FC-143:Two Year Oral,Tovicity-NcognicityStudy in Rats ---- - ----------------------------------------------Animal Number: IR-3646 So%: Mile Group: 6) FC-143 30 ppe Fate: (Neeks106) TerminalSacrifice Table: 2 RacrestapicMserva'6'ions: L@iver MicroscopicObservations: Hea,t Ki,w4ney Live, Lurj,Par!.,reas SalaivaryEl,iid Thyro'.d -Possiblypale, mottled. -Myocardiaflibrosis,sild Eyocarditis.chronicnonsup;u@ative,milld -Chronicprogressiven!pbro;it.'-o,iyl,-il -Portalsonart;,.Iecaerll inf@ltrate,mile Portalbile ductproliferationa,ild Hepatocytevicualation,aulitifocalM,inimal Nepatccytealteration,vicuclated,focal, sild -Vascularmineritlizatioani,ld -kt examined,aissing -Sialadenitisc,hroni",a,arked -HyperplasiaC, cell,focal,mild The follon@artgissueswere found to be withinnormal liaits: Spleen,Testis/EpididytisP,rostate,Stomach, UrinaryBladder,Adrenal, Farat;@yroidT,ra.-hea, Esophagus,Pituitary. -------------------------------------------------------------------------------------- Animal Nuabor: IR-'@P647 Sez: Mile Group: 1 6) FC-143 30 ppe Fite: (Weekz101)Sacrificedin ex4Lrecis Macrosc.-Fi0",,,servitiots' Pituitary S;" Stomach F.icrDscapiOcbservations: Hear-6 Kidney Liver Lur,g Pituitary Skin Stomach Testis/Epididysis - - - --------- -Raisedhew rhagicmass, 0.0 ce dia. -Raised ulceratedIasims cm both hind footpads. -Possiblearea of ulcerationin cardirl. -Nyocarditis,chronicnonsuppurative, oultifocalm,ild -Chronicprogressiveneph!-opithym,oderate Pe',vimcintralizatiors,ild -Part&'o&cnanucliiacrell infiltrates,ild -Viscu:armintra'Aizatiomni,ld Oveclar eacrophageso,ultifecil,mild Hemorrhage,aiiltifocalm,ild -Adenoto -Podadersititiasl,terativeb,ilateralm,arked -Ulcer,earkiid -Tubuleatrophy,asperseogentsis,sild Vascularminlralizationt,ild - - ------ Species:Rit Project Number: 0281CROO12 Sumarized STAR Pago: 156 322 Sum4rized Single Tabul&4u'eAdnisal Report (CCM4.inuld) .nfiv@dualRacrostopir and MicroscopicMsrvations RikerLaborato!-iosI,nc. 3m FC-14I.:Two Year Oral Toxici,6y-(Incoggn@acSittuydy in Rats ------------------ ----- ------- ----------------------- - ----------Animil,Number: IP-3647 Sex: Halt 6roup: 1 6) FC-1&4330 pps Fite: (Weeks101) Sacrificedin extresis Table: .q;&,-r,nscaOpbiscervations (contianued): Urinary flaadder -EFithelialhsyperplas@4a,s;.aple,diffuse, mild Epithel44a'h4ype,plasia,papillary, local areas,sild Calculus The followingtissues were 4oune to be within normal limits: Sp'leen,Prostate, Adreni'-,Thyroid, Parathy.-o;AdT,rachea, Esophagus, Salivary 6!&,-IdP,ancreas. ------------------------------------- ------- --------------------------------------------Ar..,IsNiulmber: IR-3648 Sex: Halt 6roup: 1 6) FC-14'43'0 pps Fa'6e, (Weekt 6t@1S)acr4lf;ce,i.n' exl%rtais Hicr.-sco;44,0,1.,se,,vations: Thymus Liver Spleen Lymph Node (ibduinal) Observptions: Lung Lymph Node (abdominal) Pancreas Pituitary Spleen Tit-.Ylius -Labulated,lig@t-greenmiss, 2.5 x I ca. in thymus area. -Pessiblyslightlypale. -Enl&argel -Renil,internaliliic lyaph nodes slightly enlargedand light greenishin color. -Leukemia, eyeloid Proteinresorptiondroplets,aild Extensiveinfiltratioonf prolifratingcells of early eyeloidseries i-,h.ilus. -Leukemia, eyelaid -Leuknia, ayeloid Hemorrhage, oultifocal,mild -Liuketia,myeloid -Mt exasined,missing -kt examined,missing -Leukemia, eyeloid -Louketia,eyiiloid The followingtissues more found to be within normal limits: Heart, Testis/Epididysis,Prostate,Stoaach,UrinaryBladder,Adrtnil,Ttyrcid,Pirithyro4&d, Tracheil Esophagus, Salivary 61and. - ---- ---- --------------------------------- ------------- Species: Rat Pro act Number: 02011.ROO12 Sumwized STAR Page: 159 323 Suu&ri:#d Single TabulatedAnimalREPOrt Icantinued) IndividualMicroscopicand MicroscopicObW vati0ftS Riker LabcritarilsI,nc. 3W FC-143:Two Year Oral Toxici4iy-oncogeniciSttyudy in Rits Table: 2 - ------ - ------------------------------------ ------- --- -- ----------------- ---------- An;sal Num@per:IR-3649 SeK: Hale Broup: 6) FC-143 30 ppm Fate: (Neeks106) TorainalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal kidney Lung Pancreas Pitu!tiry Salivarycl;rd Thy,-o@Ad -No visiblelesions. -Medullary cill hyperpais4.&,oult@focil. milmi -Chronicprogressivenophropatb?,milad -Vascular minEr&14&zationm,ild -kinar atrophy,sild -Hyptrplasiao,u!tifocalp,ars d'4staliso,'.Id -Silliden;iticsh,ronic,moderate -Hyperplas;aikr,.calbl,oulti4ocal&m,oderate Ultiar.brar.,,chyisatl The tissueswere foundto be withinnor&&]limits: Spleen.Liver, Heart, Testis/Ep4Adidyt4P&rso,state,Stomach, UrinaryBladder,Parithyroid, TrachE-i.Esc;iiia;us. -------------------------------------------------- ---------------------------- An.4,aa'Niuml.!er*IF-'IT6FO Sex:Nile Broup: fitFC-143 30 pps Fate: (Week=106)TerminalSacrifice P.a:roscpicObservations: MicroscopicObservations: Adrenal Kidney Liver Lung Pin:reas Sil-A,iarSyland -No visiblelesions. -Ccrticaldogentrat4aonf,ocal, moderate Phocchrot.-cytomim,alignint,unilateral& Neoplasticct:ls highlypleotiorph-'A,-. -Chronic p.,o;ressivenaphropithy, moderate -Forta's4onmuclear cell infiltra%les,i!.d Necrosis,focal,siniail -Yascular mintralizat;Aons,ild Alveolarmacrophiges,oul.tifocalm,ild -Aciraratrophy,moderate -Sialadenitisc,hronic,marked The io'Alovintgissueswere foundto be withinnortallimits: Sp',eenH,eart,Testis/EpididysisP,rostate,Stosach,.UrinaryBladder,Thyroid,Parathyro@d, Trichea, Esophagus,Pitu-*Atary. - -- ------- ------ ------ - ------ ---- ------------------------------------------------ Species:Rit Project Number: 0281CROO12 Swwarized STAR Page: 160 324 Sugaar;2#dSingleTabulatedAnimalReportleontinutd) IndividualRacrosco;icand MicroscopicObservations RikerLaboreories,Inc. 3M FC-143:Two Year Oral Tcxicity-OncogericitSytudy in Rats Table: 2 ------------ - ---------------------------- I - --------------------------------- --------- A.linalNuaber: IF-3651 Six: Halt Group: 1 6) FC-141@30 pps Fate: fkeekz106) TerminalSacrifice MacroscopicObservations: Kid-,ley gicrosccp4cObservations: Adrenal Esopha;us Heart k.'i,Wlney Liver Lung Pancreas Pituitary -Multiplecysts in one area of right kidney. -Corticalvacuolation,localareas,sild Sinugoidalectasia,cortex,sild -Not examined,missing -Myocarditis,chronicnonsuppurative, -Chronicprogressivenephropathy,maderite Pelvicsineralizationm,inimal Cyst,cortical,multiple -Nepatc,@ylvuatcualitior,sultifocal,sild Hopatucytealteration,vacuolated,focal., mild Negalocytosis,minimal -Vascularminerilizatiors.i,ld -Net examined,missing -Hyperplasiaf,ocal,pars distalis The followingtissues*erefound t.,be Nithiinrormallimits: Splee.-,T,estis/Epie@4,6ifPsr4o.sst,ate.54.ozathU,rinaryBladdtr,Thraid, Puithraid, Trachea, Sa!A?.Yarv ---------------------------------------- -------------------------- ------ ------------ P.nizal&NL;a.@er:IP-TWL52 Sex: Halt Sroup: 6) FC-143 30 pps Fite: 'Weekz 94) Sacri4icedin extromis Ma.,roscopicObservations: Pituitary stomach MicroscopicObservations: Adrenal Kidney Liver Lung Pituitary Prostate SPIM Stomach Thyroid Urinary Bladder - ------------------- -Enlargeddue to mass, 1.2 ca dia. -Lining appearsth4ackened(ocatitaus',; possibleulcer in card4&a. -CorticaAvacuclation,oulti4c,-alas-,."Id -Vaeuglation,conv.tub. apithe@Aus,minimal -Portalbile du.,tproliferationo.i,&ld Htpatv.ytevacuolitiond,iffuse,oild -VascularBintralizations,ild Alveolarsicrophagess,ultifocal,mili -Adeiosi -Prostatitis,acute,marked -Hotosiderosiss,ild -Ulcer, marked -HyperplasiaC, cill,oultifocalm,ild -Epithelialhyperplasia,simple,dif4use,sild Species:Rat Project Number: 0281CROO12 SumariSTzAeRPdage:161 325 SummarizedSingle TabulatedAnimal Report (CODtinued) IndividualMacroscopic and Microscopic Observations Riker Laboratories,Inc. 3M FC-143: Two Year Oral Toxicity-oncoge-,t4AciStyudy in Rats Table:2 --------- ------------- --------- --- -- -- - --- ------------- ------------------------AnisilNumber:IR-3652 Sex: Mile Broup:( 61 FC-141'0@4'p0ps Fa'6e:(Weekz 94) Sacrificedin extreais Microscopic Observations (continuelm): The followingluissues*ere found to be within normal lis@ts: Heart, Tes'6is!EpijidvaisP,arathyro@.d,TraOei, Eso;ha;us.,S31ivary Elan!, Pancreas. -------------------------------------------------------------------------------------------------- An.sal Nualwir: Sex: Male Brou;: ( 6) FC-14'v3l0 pps Fa*le: (WEe't.1-0=6"?Tartina' Sicr4lf4ice F.i-.rosc,.p-.c ?;.-.roscc;i: Test@s,@E:-Aditlymis Observations: Kidney Lung Tes4.is!Epididysis -Righttestisstall. -Chronic progressivenephropathy,mi'd -Yasculu aintrilizal.iona,@ald Hemorrhage, local areas, eaderate -Tubule atrophy, ispermatoge.-@esiusn,ilateral, marked The 4oll.ow@intgissues were found to be within normal !ioits: Spleen.,'6iver,Heirlu,Prostate, Stoeac@, Uri,-tirByladler, Adrenal, Thyroid, Parit,@yroid, Trackei, Esupha;us, Salivary Gland, P-4t-j44tarPya,ncreas. ----------------------------------------------------------------------------------------- Ar;@@oi'Nauzbe@: IR-36',j'4 Sex: Halt Fate: (Weekz 106) TerminalSacrifice Sroup: 6) FC-143 30 pps ?,icrDSCOPiCObservations: Bra@&n -Dark area, possibly old hemorrhage, ir. anteriorpart of right cerebral hemisphere. Microscopic Observations: Adrenal -Sinuicidalectasia,cortex, moderate .btocnromacytosa,benign, bilateral Bra4&n Heart -Astrocytoma, benign Large neoplast occupyin,,s,uch of cerebrum. 4yocarditis, chronic nonsuppurative, oult!4ocal,sild Kidney -Chronicprogressivenephrcpith),sild Pelvic sintral,*azatiomno,derate Liver -Hapatrcytealterition,vatualated,foci!, sild migalocyl%.Dsis.minimal Lung -Pneumonia,interstitial,chronic,ouj',tifecal, mild Alveolarmicrophiges,oultifecal,mild -- - -- ----- ---------- -------------------------------------- ---- --- Spec4.es: Rat Project kusbr: 0281CROO12 Summikr;szvdSTAR Page: 162 326 Suesir;.zeSdingleTabulatedAriisaR'egport (continued) IndividualhazrosccpicAnd MicroscopicObservations RikerLaboratoriesI,nc. 3? FC-141:Two Year Oral Toxicit-yOncogenicitSytudyin Rits ------------------------------------- -------------------- -----An@ssalNue'.tr:IR-3654 Sex: Mile Sroup:( 6) FC-14'3v0 ppe Fate: (Week='A06)TerminalSa,-rifice Table:2 Micros.,op4C.--I,servation(scortinued): Firicreas Pirithyroid -Acifkar'strophmyo,derate -Notexamined,not in planeof section Tt.efa!lomingtissueswerefoundto be withinnormalli@4ts: Splee.nT,es'Lis/EpididyiiPsr,ostate,Stomach,UriniryBladder,Thyroid,Trachea,Esop@i;us, Sa'sivarSyliridP,ituitary. -------------------------------------------------------------------------------------- Anisal Number: IR-7.6'@5 Sex: Male Group: 6) FC-14330 pps Fate:(Week=106)TerminalSacrifice MicroscopicObservations: SoftTissues(neck) Tes+is!!Epididysis N44,.ros:op@Oabcservati*rs: Ad!,enil Kidney Lur,; SalivaryBlind Testi.slEpid'Adyo;is -Mass,4 1 2.5 1 2 ce, salivaryglandarea, -Righttestisenlarged,pale yellowish1.1.c1e, dia. mass. -Corticalvicuolitior4.c,cal,a@ald -Chronicprogressivnetphropithy,acderite Pelvicsineralizat'6omni,ld -Yascularsineralizationm,ild Alveolareacrophages,localareas, mcderate -SialidenitisA,cute,marked -Tubuleatrophy,ispermatagenesiusn,ilateral, moderate Leydigcelladenosa,unilateral TI-te tisst;ewserefounwtlo be withinncroillimits: S;*.ee,L@4,&,verH,eart,Prostate,Stuach, UrinaryBladder,Thyroid,Parathyroid,Trlche'l., Esophagus,Pitt;4AtaryP,ancreas. ---------------------------------------------------------------------------------------- AnisilWausber:tP-3i56 Sex:Male Group:( 6) FC-14330 ppe Fite:(Week=85)Sacrificeidn extruis MicroscopicObservations: Pituitary MicroscopicObservations: Adrinikl Kidney Liver Lung -Largemass,I x 0.7 eikdia. -Corticavlacualationf,ocal,sild Sinusoidaelctisia,cortex,mild -Chronicprogressivenephropathy,minimal -HepatKytovkuolation,diffuse,moderate -Yascularmineralizationm,ild Nuorrhige,oultifocalm,ild - - ---------- Species:Rat Project Number: 020!CROO12 Susw ized STAR Page: 163 327 SummarizeSdingleTabulateAdnimalReport(cor.41inued) IndividualMicroscopicand Microscopicobservations Riker Laborator-tesJ,rc. 3M FC-143: Two Year oral Toxicity-oncogenicityStudy in R&4@,s Table:2 ------------------------------------------------------------------------ ----------- Animal Number: IR-3656 Six:Mile 6roup: ( 6) F@u'-143104ppi Fate:(Week= 251,Sacrificeidn eltresis M-',@,ros,-Oobpsiec."vationfsccntin-.,td): Parit,lyroid P@.tu4&4.ary - -)rotexamined,not in planeof section -AdenDmi -Not examined,missing Tt,e '.issuemserefoundto be withinnormallimits: Sp!ee7,Hei-t,"eslkis/EpididysPirso,state,Stomach,0?,irarByladder,Thyroid,Trachea, Escphigus,Pancreas. -------------------------------------------------------------------------------------------- An4,aalN@.,ee-: Sex: Hale GROLP: t 6) FC-14330 pps File:(Neekz 65) Sicr,.'fiicneedxtresis Observat4otis: Fituitary N44c.cs:o;;O.bcservations: Lu,-,; Pancreas Fituitary SalivarySland -Enlarged,0.6 co dia. -Myocarditisc,hronicnmsuppurative,focal, moderate -Portalsonmucleircellinfiltratem,ild -Vascularmineralizitionm,ild Alveolarmicrophigeso,ulti4ocal,oilad Hemorrhage,localareas,sild -kinar atrophy,minimal -Adencea -Not examined,missing The followingtissueswerefoundto be mithinnor&&!limits: S;IaeenK,idney,Testis,'Ep;sdidysPirso,state,Stomach,UrinaryBladder,Adrenal,Thyroid, Piratlyro-A*Tdr,achea,Esophagus. ------------------- --- -- ---------------------------------- ---------------------- Ari;aaiNluamber: 1R-3658 Sex: Hale Sroup: 6) FC-14'340 pps Fal%e:(Weekz106)TerminalSacrifice Microscopic Observa&6ions: Eye MicroscopicObservations: Eye Kidney Liver Lun; -Righteye appearscloudy. -Keratitisc,hriniicu,nilaterals&i,ld -Chron;&pcrogressivenephropithy,sild -Nepitacytaelteratiopv,atualateds,ulti4ccal, mild negalocytosism,inimal -Vis.-ulsairntrili,.atimoirl,d, Alveolareacrophageso,ultifocals,ild Species:Rat ProjectNumber:0261!RO'012 Summarized STAR Page: 164 328 SuftarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicAnd MicroscopicObservations RikerLaboratoriesI,nc. 3M FC--1437:ticYear Oral Toxicity-oncogenicitSytudy in Rats Table: 14 ------------------------------------------------------------------------------------- An-A'saNlumber: IR-3656 Sex: Male Group:( 6) FC-14330 ppe Fate: (WE*k- 106,T1erminalSacrifice MicroscopiOcbservation(scontinued): flt@u.-'tary Thy-aid -'ist,parsdistal,*s -HyperplasiaC, cell,4ocil,moderate T.he T@ISSLBwSere found to be withinnormal limits: Spleer,Nei-t,@ies+@istEpididymPirso.state,Stomach,UrinaryBladder,Adrenal,Par.614hyrucil Trict.eiE,sopt.&;!.S!asl,ivaryGland,Pancreas. -------------------------------------------------------------------------------------------- AnitalNigber:IR-3659 Six:Mile Group: 6) FC-14330 pps Fate: (Neekz 96)Sacrificedin extremis MacroscopicObservations: Pituitary Liver Mi.-roscr,p4OAbcservat@.ons: Adrepa'A Kidney Liver Lung Pa,-at@!Y'Cid Pituitary Splegi Testis.!E;4didymis -Largehemorrhagicmass, 1.4 x 0.8 ca. -Paleand mottled. -Corticavlacualitiond,iffuse,ii'4d Sinuscidil@-,tasiac,v.tel,mile -Chronicprogressivneephropithys,ild Pelvicmintralaizatieoinr,ttd -Portalsononucleacrellinfiltrates,ild Pwtal bileductproliferatiomni,ld Hepatocytevicualitionp,eriportal,moderate -Viksculmairntralizitiosni,ld -Not examined,not in plantof se:i-.;&on -Adetioca -Henosiderotise,i:d -Vas.-ulasrine,ilizatj"omni,ld The followingtissueswerefoundto be withitnoraillimits: Prostate,Stosich,UrinaryPlidder,Thyro'.dT,rachea,EsophigLS,S&144vargylard,Plrcrt-as. ------------------------------------------------------------------------------------- A,-.-a*Nmuaalter: Sex: Mile Group: 1 6) FE-14'3;0 ppe Fi'6e: (Wee*vz106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Heart Kidney Liver -No visiblelesions. -Sinusaidaelclkisiic,ortex,sild -Kyocarditisc,hronicnonsuppurative, sultifocals,ild -Chronicprogressivneophropithys,ild -Portalsononecleacrellinfiltratem,ild Pvtal bileductproliferatiomni,ld Species:Rat Project Number: 0281CROO12 SusairizedSTAR Page: IS5 329 SummarizedSingle TabulatedAnimal Report (continued) IndividuaMlicroscopiacnd MicroscopiDcbsrvaticns Rike,LaboratoriesI,nc. 3" FC-143: Two Year Or&! Toxicity-OncDgenicitYStudy in Rats Table:2 -- ------------------ ---- ------------------------------------------------------------ Animal Number:IR-3660 Sex: Male Broup: 1 61 FC-14!v30 ppt Fite: iiieek1=06)TerminalSacrifice Micros-,epiOcbservationsicontinued): Lung Para'6-@yroid Thyroid -Vasculasrintralititiosni,ld Pneumonia,interstitialc,hronic,focal,mild Alvoolar sacrophagtls,ultifocal,m;&'&d -N2t exa' mined,not in planeof section -C celladenosa,unilateral Ultioubranchiatlys', The following tissueswerefoundto be withinnormallimits: Spleer.T,est;.s!EpidiwlysPi,sa,state,Stomach,UrinaryBladder,7richti,Esophagus, Salivary61,i..Fi@dt,uitary,Parcreas. ---------------------------------------------------- ----------:------------------------- Animal Number:IR-3661 Sex: Mile Broup:( 6) FC-14330 ;pt File:iweek-106)TerminalSacrifice MicroscopicObservations: @icrescopicObservations: Adrenal Heart K'Adr.ey Lung Salivaryisan'. -No visiblelesions. -Corticalvacu-.Iaticfmo.@,al,sild -Myo,.irditisc,hronicnon;uppurat@ave, oultifocalssi,ld -Chronicprogress-*.nYoeohropathy,a;ld -Vispularaineral;4:atiomni,*.d -Sialadeniticsh,roric,sild Thefo'A'&omitn4g.ssiewsere foundto be withinftermilimits: ' Spieen,Liver,Test4,s.'Ep;6did@Pmrio.sst,ate,Stomach,UrinaryBladder,Thyroid,Parathyroid, Trachea,EsoPp, %i;,@sP,ituitary,Pancreas. ------------------------------------------------------------------------------------- Ar,;INiuimib!erI:R-3662 Sex: Halt 6roup:1 6) FC-14330 ppe F;*E:(Week= 94) Sacrificeidn extresis MacroscopicObservations: Eye Lung Spleen Liver Kidney 7estis/Epididysis MicroscopicObservations: Adrenal -Bilateraalpa:ities -Nultiplwehitelesions,0.2cm dia.,in left lobe. -Slightlyenlarged -Mass,4.5 x 4 1 2 ca. leftlaterallobe. -Bothkidneyspileand enlarged. -Bothtestesvery small. -Sinuscidialctasia,cortex,mild - ------------- Species:Rat Project Number: 0281CROO12 Somarized STAR Page: 166 330 Sunarized SinglatTabulatedAnisilReport (continued) IfidividuaMlacroscopicand Mitroseopicobservations RikerLaboratoriesI.nt. 3M FE-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: --------------------------------------- ------------------------------------------------An4sal Number: IR-3662 Se%: Mile Group: 6) FC-14'v@'JOppe Fate: (Week= 94) Sacrificedin extresis MicroscopicObservat@ons(continued): Eye Heart K@,d-.c-,.i Liver Lut,g Parat@.yraid Pituitary Tes'Lis/Epididysis Thyroid UrinaryFlidder -Cataract,tilateral -Myncirditis,chronicnonsuppurative, oultifccalg,ild -Chronicprogressivenophropathy,markei Pyllitisi,cute,mild Cyst, cor4-icilm,oderate -Portz)senonucleacrillinfiltrates,ild Portilbileductproliferations,ild Nepitacytealteration,vacuolited,focal, mild Nepatocellularcarcinoma Large,poorlydifferentiatedneoplasm. Trabecularand adenoidpatterns. -Vascularmineralizations,ild Alveolareacrophiges,oultifocal,mild Hemorrhage,local areas,vild -Not examined,not in plane of section -Cyst,pars distalis -Tubuleatrophy,ispereatogentsisb.ilateral, sild -Not examined,not in plantof section -Epitheliahlyperplasias,imple,dificse,vild Cystitis,chroric,diffuse,sin4amil Tl,-f.o,'e-Ioviitiisgsueswere found to be withinnormal limits: S;Ieen,Prostate,Stomach,Trachea,Esophagus,SalivaryBland, Pancreas. ---------------------------------------- - -------------------------- Aninal Number: IR-366Z Six: Mile Group: ( 6) FC-14330 pps Fate: (Weeks!06)TerairalSacrifice macroscopicObservations: Kidney MicroscopicObservations: Kidney Liver Lung -Cyst, 4 ce d,'Aa. -Chronicprogressivenephropathy,moderate -Oortal@o?.Ionuclecaerl'iinfiltrate,sild Portalbileductproliferationm,ild -Vascularmineralizations,ild The folalovintgissueswere found to be withinnoreal 1;.oits: Spleen, Heart, Testis/Ep4.d@AdysiPsr,ostate,Stomach,Orirary Bladder,Adrenal.,Thyroid, Parathyraid,Trachea,Esophagus,SalivaryGland, Pituitary,Pancreas. - -------------------- --- --- Species: Ral. Project Number: 0221CROO12 Susearized STAR Page: 167 3 3 1 Suo&ar;-,LSiidngleTabulatedAri;saRleport (continuki ineivi;u4ll ma-.roscopic and MicroscopicObservations RikerLaboratories,Inc. 3m FC-34'v:Two Year oral TaxicitY-OncoginicitSytudy in Rats Table: 2 -------------------------- ------------ ------------------------------------- ------- Animal Number: IR-3664 Sex: hale Group: 6) FC-14"v3l0 ppe Fite: (Reek=106) Teraina'Sacriiice MicroscopicObservations: MicroscopicObSefVitiOrg: Heart Liver Lung -Nyocarditis,chronicnorsupplirative, oultifocalm,ild -Hyperp'@asiaK,upfier cell, d'afiuse.soee-a4le -yascularmineralizationt,ild' Hemorrhage, locil areas, m@&ld The followingtissueswere foundto be withinnervialimits: Spleen,Kidney,Tes4tis/Epid4dys@P.rso,state,Stomach,UrinaryBladder,Adrenal,Thyroid, Paral,hyrc;-7,r.ict..eEas.ophagus,SalivaryBlind.Pituitary,Pancreas. --------------------------- ------ ---------- -- ---------- -- ---- ------------------------------ Ar,,*.iNtLamlber: IR-3665 Sex: Mile Group: 6) FC-14.130 ppo FitE: (Weeis 401 Sacrificedin ext,e2is MicroscopicObservations: Liver Spleen Massiry Gland Hicrescapi:Observations: Liver Parathyraid Ski.n. S;,Aten -Slightlypall -Slig".Iyenlarged -Mass with ulceratedhemorr@.agicsuriace,6.5 1 6 K 4.5 ce, in ri-ht axilla. -Necrosis,centrilobulart,ild Negatopoilsis,extramedullarym,ild -Not examined,not in plantof section 4ibrosi-coma Highlycellularneoplasmwith lymphatic invasion. Surfaceulcerated. -4satopoitsis,extrooodullaryi,ncreased, marked The followingtissueswere foundto be withinnorea! limits: Kidney,Heart,Lung, Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Adrenal,Thyroid, Trachea,Esophagus,SalivaryGland,Pituitary,Pancreas. --------- -- -- - --- --- ---------------------:---- ----------------------------- ------Animal Number: IR-3666 Sex: Nale Broup: 1 6) FC-14")7.0ppe Fite: lkeek-t06)TerminalSacrifice MicroscopicObservations: Eye -opacity,righteye. Skin -Hairless on limbswith stab formation; possibledereatitis. Pituitary -Raiseddirksiss,0.8 co dii. -------- - --- ----------------- -------------------- -- - ---------- Species: Ral. Project Number: 0281CROO12 Summarized.STAR Page: 166 3 3 2 Sunari,SeidnglTeabulatAendisaRlepor(tcontinued) IndividualHicroscopicand HicrostdpicObservations RikerLaboratoriesI,nc. 3H FE-143:Two Year Oral Taxic;tty-oncl)geniSctiutdyy in Rits Table:2 - ---------------------------------------------------------------------------------- An.isaiNumber: IR-')666 Sex: Halt Group: 6) FC-14330 PPI File:(W2ei.1=06)TerminalSacrifice nicrescepiO:bservationiscantinued): I" ey (c^!t" -I-,ad) Eye Heart F'.idney Live- Lu,i; Parcreas Pituitary Saliv.i-Sylind Skin Tes,Lis!Epiadi.wiylis -File;possiblysomewhatenlarged. -Sinusoidaelctasii,cortex,moderate -Retinal#trophy,uniiallefal Catiractu,nilateral -Nyocardiaflibrosis,fo,-&!,sild -Chronicprogressivenephropathy,eaderite -Po,taltopmuclearcellinfiltrates,:ld Hananucleacrellinfiltrationa,u!t4A4ocil, mild -Vascularsiner&'Liziti-m.inl,d Reterrt.igleo,cali&rvis,sild -PDlyarl.eri46oisr,isil -Aderati -S4&aiadetiticsh,ronic,moderate -Ulcer,&irked -Po!yarteritimsi,ld T@,e tiss,.-es were found 16c be within normallimits: 5 ;rcsl,iteS,tomach,UriniryBladder,Thyroid,PirithyraidT,rachea,EsophigL-s. ----------------------------------------------- --- --- --- -- ----------------------- A-@.iaaNluit!r: IF-366'1 Six:Nile Broup: t 6) FC-14.3101 ppe Fite:(Week=106)TerminalSacrifice ,4&croscopiOcbservitions: MicroscopicClaservations: Heart Kidney Liver Lung Pancreas Pitu4,tiry SalivaryBlind Thyroid UrinaryBladder -No visiblelesions. -Kyocarditisc,hronicnorvsuppurit-ave, aultifocals,ild -Chronicprogressivenephrepathy,aild Pyelit-*&asc,ute,sild -Portalsonana@-leacalrl infiltrate,e;ilad Portalbiltductproliferatiomni,ld -Vasculaarintralizatioani,ld -Acinaratrochy,gild -Adeins -S;.alideniticsh,ronic,marked -Hyperplisia,C call, fo,.ii@l4&.,1d -Not examined,missing Thefollanintgistutsor* foundto be withinnorul limits: Spletp,Testis[EpididysiPtr,ostate,Stomach,Adrenal,Parathyroid,Trachea,Esophagus. Species:Rat ProjectLaber: 02elCROOII& Sumarized STAR Page: 16q 333 Sumarized SingleTabulatedAnimalReport (colitinued) IndividualMacroscopicand Ritrostgpicobservations RikerLaboratoriesI,nc. 3H FC-143:Two Year oral Toxicity-oncegeniciSttyudyin Rats -------------------------------------------- - ----------------------Animal Wasluer:IR-3668 Sex: N&141 Group: 6) FC-14%13)0 pp2 Fate: (Weeka106) TerminalSacrifice Table: ------------- MicroscopicObservations: P.@AcroscapiOcbservations: Adrenal Hea.-16 Liver Lung Pi'6u@Atary -No visiblelesions. -Einusaidae!ctasia,cortex,sild -Nyocarditisc,hronicraniuppurative, BU)Iuifoca0l4,&ld -Chronicprcgressivnetotrapathym,iniel -Portalsonanucleicrell infilatr&'sLit@,d Necrosis,focal,@4.1d -Vaiiculsairntralizatiosri,l,d Hiscrrhageo,ultifocale,itd -Adenrisa The fo'.Icw'.lri@igss-jieisere4ouidto be withinnormallimits: Sp.'AeeTne,stis/Ep,'.didfsPirso,state,Stomach,LlrinarByladder,Thyroid,Parathyro,*.Tdr,achea, Esophagus,SalivaryBlind,Pancreas. - -- -- ------------------------------------------------------ --------------------- Animal Number: IR-10669 Sex: Kale Group: 6) FC-14330 ppe Fate:(Neekz70)Sac,ificeidn extrebis MicroscopicObservit;lons: Skin LargeIntestine Liver MicroscopicObservaticms: Adrina" Esophagus Lung Parithyraid SalivaryBland Skin Thyroid Trachea -Leftsideof scratueulceratedwith rectal-scrotaalbscess. -Markedimpactionat terminalcolonand dilatitniof re"iningcolonand ilaeus containi'ngfecaloal%.eial. -Palo -lithinnormallimits Ono of pair present -Not examined,missing -Alveolarearrophigeso,ultifocalm,ild Ntoorrhageo,ultifocalm,ild -Not examined,missing -Not examined,missing -Abscess,subcutaneous -Not examined,missing -Not examined,sissin; The followingtissueswere foundto be withinnormallimits: Spleen,Liver,Kidney,Neart,Testis/EpididysiPsr,ostate,Stomach,UrinaryBladder,Pituitary, SmallIntestine,'LargIentestine,Pancreas. Species:Rat ProjectNumber:0281CM12 SussarizedSTAR Page: 170 334 summarizedSipgleTabulatedAnisilReport (continued) individualNacroscaPicand MicroscopicObsrvations RikerLaboratoriesI,nc. 3H FC-143:Tva YearOral Toxicity-DncogenicitSytudy in Rats Table:2 ------ ---------------- --------------------- ------------------------------ --- AnimalNumber: IR-3670 Six:Kilt Group: 6) FC-14330 ppe Fate:(Meek=106)Teraina!Sacrifice f.acroscopiOcbservations: Hicroscc,-4sru-bserval,,ions: K@id!@ey Liver Lung Pancreas p.iL.&4ary .U . 6 Salivary BA"and Tes'l.'s!Epididys@L -Mass,I."1 1.07ce in areaof pancreas. -Enlarged,paleand pitted. -Chronicprogressivenephrepathy,eirkel -Portalsononucleacrellinfi!4tratmei,ld Parta!b4AIteuctproliferationm,i'd -Vascularmineralizationm,ild -Adenocarcinomi Welldifferentiatedu,ctularpattern. Large amountof fibrousstrana. Acinaratrophy,sild Polyarteritism,oderate -Adenosa -Sialadenitisc,hronic,moderate -Polyarteritimso,derate The folaluioitrigssues*eresfoundto be uithinnormallimits: Spleen,Heart.Prostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Parathyroid,Trachea, Esophagus,LymphMade isesinteric). -- ---- --------------------- -- --- -- -------------- -- -- ---------------------- An44@alNumber: IR-3671 So%: Halt Group: 6) FC-14330 pps 'ate:(kekz 106)TerminalSacrifice Racrosco;izObservi'6ions: Hi@6rDsccpiObcsfrya'6-iors: Adrenal Esophagus Kidney L'ayer Lur,g Pancreas Parathyro.*d Salivar-Biland TestistEpididy@4.s Thyroid Trachoa -Sinuse-4daelctit-4a,cortex,ail,.4 -Mt examined,missing -Chronicprogressivenepik@ropithmya,rked -Portalsonanucleatrellinfiltrates,ild -Vascularmineralizationm,ild Perivisculimronanucleairnfiltrates,ild -Acinaratrophy,sild -Not examined,missing -Not examined,missing -Polyarteritism,oderate -Not examined,missing -Not examined,missing Thefollosintgissueswe foundto be vithinnormallimits: Spleen,Heart,Prostate,Stomach,UrinaryBladder,Pituitary. -- -- ------ ---------- ------------------------ Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 171 335 SummarizedSingle TabulatedAnimal Report (CcntiPued) IndividualMacroscopicand HicrestapicObservations RikerLaboratoriesI,nc. 3N FC-143:Two Year Oral Tcxicity-oncogenicitSytudy in RatA Table: -------- ---- ----- -------------------- ------------------ - -------------- ----------- Animal Number: IR-3672 Sex: Nale Sroup: 6) Frw-14330 ppe Fite: !Week=106)TerminalSacrifice Racrosco;icObservations: Fi'6uil6ary Testisj'Epid;Adysig NicroscapicObservations: @,'idney Liver Lung Parathyroid Pituitary Testis/Ep4adidymis Thyroid area -Lofttestissmall. -Chronic progressivenaphropithy,minimal -Portalsononucleacrell infiltratea,4ld Kepatocytealteration,basophilit,focal, sild -Yascularti-ieralaization4,.1d -Molte,xamined,not in plane of section -Adencea -Tubuleatrophy,ispermatogenesisu,nilateral, marked -Cyst,colloid The followingtissueswere foundto be withinnormal limits: Spleen,Heirt, Prostate,Stomach,UrinaryBladder,Adrenal,Trachti,Esophagus.S,alivaryel.and, Pancreas. -- ------------------------ -- -- - ----- - -- ------------------------------------ ----- Anisal&Number: IR-3673 Sex: Nile 6rou;: 6) FE-14%?U) ppe Fate: (Week=106)TerminalSacrifice Hicroscop4lcObservations: MicroscopicObservations: Kidney L'4ver Lung Pancreas SalivaryBland -No visiblelesions. -Chroqi,-prdgressivenep@ropill-hys,ild -Portalsonarucleatrellinfiltrates,ild Hipatacytealteritior,Y,acuc'4atedo,u',tifocal, aild M;ga!ocylosis,minimal -Yascularsiieralizations,ild Perivisculasrononucleairnfiltrates,ild -Hyperplasiaa,cinarcell,nodular,mild -Sialadenitisc,hronic,moderate The followingtissueswere foundto be withinnormal limits: Spleen,Heart,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Adrenal,Thyroid, Parathyraid,Trachea,Esophagus,Pituitary. - ---- ----- - ---------------------------- Specits;Rat Project Number: 0281CM12 Smarized STM Page: 172 336 SummarizedSinglt TabulatedAnimal Report (.continued) IndividualRacroscopitAnd MicroscopicObSOrvat4auns RikerLaboratoriesI,nc. 3" FC-14TTVw:o Year Oral7oxicity-DncogeniCiSttYudyin Rats Table: 2 -------------------------------------------------- ------------------------------ Animil Number: IR-3674 Sex: Nale Group: 6) FC-147V.30pps Fate: (Weei=10i) TerminalSacrifice Ma:roscapicObservations: MicroscopicObservations: Heart Kidr.ey Liver Lung Parathyroid -No visiblelesions. -Myocardiaflibrosis,oultifocalm,ild Myccarditis,chronicnorisuppuralive., sultifocals,ild -Chron4icprogressivenephropathy,mild -PortalDonaru-,leacrell infilatratem,ilbd Cystoiddegeneration,4ocal,sild Nepatocyteilteriticn,vacualaluedB,L!t;4iCC&I, mild -Vasculars;anerilizil,,eiic,nd, -No'%e,xaminedn,otin pIanEof section The folilow4antgissues were foundto be withinnormallimits: Spleen,Tes'6-is/EpididysPirsa,itite,Stomach,UriniryBladder,Adrenal,Thyro;.dT,rachea, Es2p@i;us,Sil&;AvaBrlyi@d, Pituitary,Pancreas. - -- ----------------------------------------------- - -- ------- -------------- An;gtt'NiUikber:'.P-7.675 Six: gale GrouA: 61 FC-14t%3"0 pps Fite: (Weekm 94) Sacrificedin extresis Ma,@rosco;-@cObservations: Skin Pituitary MicroscopicOlservitions: Heart Ki,4'ney Li-ier Lung Pancreas Pituitary Skin Testis/Ep;tdidysis -Raisedarea of-thckeniftgI,..rcpe dia., in neck art&; possiblyinflammation or tumorl,.perinilieaslionappearsto be inilimed areaof subcutaneousfit. -Slightlyenlargeddue to hemorrhagicarea, 0.4 cs"dia. -Myocarditisc,hronicnorsuppuritivem,ild -Chronic progressivenop@ropathy,a;Ald -Cystoiddegenerationo,ultifocal,o4.ld -Vascularmineralizationt,ild Hemorrhage,localareas, sild -Hyperplasiai,sletcell,nodulir,sild -Adenoma -Fibosircosa, subcutaneous -Vascularmineralizationm,ild The followingtissueswere foundto be withinnormallimits: Spleen,Prostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Parathyroid,Trachea, Esophagus, Salivary Blind,Mammary El.and. - - ---------- ---------------- -------------------------- Species:Rit Project Number: 0291CROO12 Smarized STAR Page: In 337 SummarizedSingle TabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratories,Inc. 3m FC-143:Tma Year Oral Toxicity-OneagonicitSytudy in Rits ---- ----------------- - --------------Animal Number: IR-U7& Box: Hall Group: 6) FC-143 30 ppe Fate: (Week=106)TerminalSacrifice Tablle: Racrescopicobservations: So4tTissues(leg) Resentery Kidney Lymp4-N1zde isesenteric) Hicr,@scapicOllservat;ions: Adrenal Bcne @.ear'L Kidne-f Lung Mesentery Pancreas Pituitary Silivar@,6'4&id Tes'L.ii/E;id;Ldys4as -Swollenrightand lefthind feet. -Vesselsthickened -Pile,pitted,enlarged. -Enlarged -Corticalvicualation,localareas,sild Medullaryce'.1hyperplas@a,sultifoca!,aild -Arthritis,synov4.4lijso;ints,moderate -Myocardialfibresis,local areas,a-41d -Chronicprogressiveiiephro;athy&,irked -Vascu!ir sinera'4izatio@m-i.l.d, -Polyi@4.eritism,arked -Polyir'6eritimso,derate -Cyst,pars distalis -Sialadeni'6isc,hronic,marked -Polyarteritism,oderate -Tubuleatrophy,aspersatagenesisu,nilateral. marked Polyarteritiss,aekid Tl.efc'*Iooiitri:s;sues*are foundto be withinnormal limits: Liver,Pr,-.statSel,iotac@U,riniryBlaidlerT,hyroid,Paratbyroid,Trachea,Esophagus. -------------------------------------------------------------------------------------------- 4nimal Number; 'AR-7671' Sex: Mile Group: 6) FC-14330 ppi File: (Week=106)Ters-inaS!acrifice F.acroscofp-O.b.s-ervat4bois: 94crosco@ir-Observi4.,ions: ESOPLIgus Kidney Liver Lung Parithyraid -- ----------------- ----- -No visiblelesions. -lot examined,missing -Chronicprogressivenaphropithy,mild -Portalsononlcleacre'&lin4iltrites,ild Cystaiddegentratiorf,o,cal,sild Nepatocyte vacualated,oull%;Afocal, s;ld F;galocytesis,minimal Necrosis,oultifocal,mild -Vascu!arminera'Aizatim,mild Pneumonia,interstitialc,hronic,oultifocilp sild -kt examined,not in plate *4 section Species:Rat Project Number: 0281CROO12 k-searizedSTAR Page: 174 338 SummarizedSingleTabulatedA,-,igRielport (continued) IndividualMicroscopicAnd MicroscopicObservations RikerLaborailarieIsn,c. 3H FC-143:Two Year Oril Toxicity-oncogenicitSytudy in Rats Table:2 ---------------------------------- - ---- --- -------------------------- AnisilNumber:IR-3677 Sex: Ma!e Group: 6) FC-1437.0ppe Fate:(Netiz106)TerminalSa:rifice Micros:cpicCu4servation(scontinued): Tes'6is/Epid4tdysis -polyarteritissi,ld Leydigcell adencea,unilatera! The followingtissueswerefoundto be withinnormallimits: Spleen,Heart,Prostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Trachea,SalivaryBlind, PituitaryP,aicreas. ------------------------------------------------- ------------ - -- ---------------------- Animal N@,.B4werI:F-367E Sax: Male Group: 6) FC-143'JOppe Fa,@LE(:@eekm 69) Sitrif;cedin extresis tacresio;icObservi4u,41ons: Liver MicroscopicObservations: Kidney Liver Lung Pituitary Spleen Stoeact -Hemorrhagimcass, I x 0.7 ce dia. -Possiblsylightlypile. -Chronicprogressivenephropathys,ild -Portalnononucliicaerllinfiltrates,ild Portalbileductproliferatiomni,ld Hep&tKyte vacuolitiond,iffuse,moderate -Vascularsintralizationi,ii'Ad Hemorrhageo,ultifocalm,ild -Adenosa -Henosiderosism,ild -Ulcer,marked The followingtissueswerefoundto be withinnormallimits: Heart,Testis/EpididysiPsr,ostate,UrinaryBladder,Adrenal,Thyr3id,ParathyraidT,rachea, Esophagus,SalivaryBland, Pancreas. ------------------------------------------ - --------- -------------------------- Animal Number: JR-7,67S Sex: Nile Group:( 6) FC-14330 ppe Fate:(Weeks106)Tesinal Sacrifice Racrofcop@.Ocbservations: MicroscopicObservations: Heart Kidney Lung Pancreas -No visiblelesions. -Myocardiaflibrosiso,ultifozals,ild -Chronicprogressivenephropathy,ei'Ad -Vascularmineraliziitiomni,ld Hemorrhage,local areas,moderate -Hyperplas4Lac,inarcell,nodular,moderate The follov;4ntgissueswerefoundto be withinnormalliaits: Spleen,Liver,Testis/EpididysiPsr,ostate,Stomach,UrinaryBladder,Adrenal,Thyroid, -- - - -- --- - - --------- -- --- ------------- species:Rat Project Number: 02#ICROOI&2 Sustar4.@.i-'.uTAFFige: 171. 12'Za SummarizedSirgle TabulatedAriiailRepc.-" IndividualMacruscopitand ritras.-Opic RikerLibaratc-its:,-,Z. Fr6-14'vTlN:o Year Ora'. ir Ri'.s ------------------------------------------------------------------------------------------------- ;Li;amaNlucoe.,: IF-16 File: [6z-Ef.= 'rera4A,,i! 6 Sroup: 6) Fr-14-30 ppp TI.-e +4SE"Ec 4fre fot:r,-i,,'';lo-eoz.thi!i-6,-ri! Es-61-.j16@igSuasl,ivary FitLit&ry. ---------------------------------------------------------------------------------------------- !--Tk P," Sev: Male fir:u;:f 6) F'6"-14"4@7;,pt;g Fi4E: ' le4t eye. will. it'i.,,ed le yi46?,.e,y ive- S:ft 'iissjesiabul.-lieni -Citirict, unili46tral pro;ress-.Yent;hropil@h),e:,alerite pyt:;.tisa,cute,IiIju -Portalsermuclei, cell,irkf."Itratgei,ld -V,s:u,4&rlineraliza,6iorg.i.l,d -Siiliderilu;acsh,ro,-ii,m.a,rked -Fibrati -he @@;lein, h t;4ss-.eswfrri to be wilutin-@crul limits: Pr:slale,Stomach, Urinary Bladder, Adrenal, Thyroid, Trac@-fa,Es.3ptii-!uPi,tu;ltary,Pancreas. ------------------------------------------------------------------------------------------ Nurter: I.R-4631 Sex: Mile 'ai6-e(:Week=10i) Terminal Sacrifice Broup: 6) FC-143 30 pps Ric,-lsr.Dpi-6 Skin Pituitary Nzicrosc,.ipOibcservations: Kidney Liver Lung Pituitary Prostate Skin -- ------- --- -------- -Raised ulceratedinflammatorylesiois,rig,lt and left hind footpids. -Seal! raised hisorrhag4alcesion, 0.2 co dia. -Chronic progressivenephropal,by,mild -Portal%or-muclearcell infiltrate,sild -Vascular miner&',izationm,ild Pnouso,iiai,nterstitial,chronic, @;,Id Perivas-.vlasrononucleirinfiltrate,mild -Adenosa -Prostatitis,acute,ail&d -Pedodereatitisu,lcerative,bilateral, hindleg, urked Species: Rat Project Number: 0281CROO12 Summarized STAR Pagf: 176 3 4 0 SuuarizedSingleTabulatedAnjul Re;ort(continued) Individua'R4acrcs6'oPi&ClidMicroscopicobservations RikerLaboratories!,nc. 38 F'6-14,T@w:o Year Ora! Toxicity-oneagen;ciSttyudy in Rits -------------------------------------------------------- -------------AnisalNumber: IR-3681 Sex: Male Group:( 6) FC-14I3.0 ppe Fate: !Oeekz106) Tormini'SLicrifice Table:2 - --- ------ P.icrosccpi0c1@%servalui(ocnosntinued): -Fclliculahryperplas4acay,stic,unilateral, @irked The 4ollowin;tissueswerefoundte be withinnormallimits: Spleen,Heirt,Tes'6is/EpiditysSitso,mach,UrinaryBladder,Adrenal,Parathyro;dT,ractea, Escphigus,SalivaryGland,Pancreas. --------------------------------------------------------------------------------------- An4sal,Nusbar:IR-3682 Sex: Mal.e Group: t 6) FC-14.13@0 ppi Fate: iWeek.1-0-61lerainalSlacrifice Macros:o;icOtserval@.ions: Liver HicrosconicObservations: Adrenal Kidney Liver Lur,g Testis.'Epidid-,@mis D.Vro;.d -Mottled -Corticilvkacual.itiolno,calareas,ail,d Nodularhyperplasia,t*te@.f,ocal,moderate -Chronicprcgressivenophropathy,mil.d calculus,pelvic -Pcrtala.-nmiic'.ceaalrlinfiltrates.ild Portalbileductproliferatiosni,ld Cystoiddegenerationo,ulti4ocal,t4&'&d -Viscu'4ar sinerali,.aa-t4i1o&rd,, Alveolareacrophiges.l,ocalareas,no.,Ierate -Leydilcellhyperplas;.&, eiad -HyperplasiaC, cell,4ocalam,ild Folliculaardenoti 'ihefollowingtissuesmire4cundtc be withinnorti'l4imits: Spleen,Heir,6S,tomach,LWinaryBladder,Parathyroid,Prostate,Trachea,Esophagus, Sil4svarGylal%dP,ituitary,Pancreas. --------------------------------------------------------------------------------------- An;&&'Nuaber: IR-3683 Six:Kale Group:( 6) FC-14'3p0 ppe Fate: (Metia1&06)TiirginiSlacrifice P,acroscapicObservat4aans: -No visiblelesions. MicroscopicObservations: Kidney -Chronicprogressivenep,@ropathys,ild Liver -Nepatocytaolteratioiv,atuclated, loca!areas,moderate Lur.g -Yascularsineral-Azatioan-,Ald Alveolarsa-.rophageosu,ltifocals,ild ------------------------------ ------------ --------- ------------- species:Rat Project k-aber: 0281CROO12 Summarized STAR Page: 177 341 SustarizedSingleTabulatedAnimalReport (tontinued) IndividualMacroscopi-candMicroscopicObservations RikerLiibratorilIin,c.. 3N FC-147T.w:o Year Oral 70'icity-OneageniciSttyudyin Rits Table: 2 ----------------------------------- ------------ ------------------------------------- Animal,Number: IR-3693 Sax: Mile Group: 6) FC-143 30 pps Fate: (Metiz106)TerminalSacrifice MicroscopicObservations(continued): Parathyrzid -Not examined,not in plane of section The followingt:ssueswere foundto be withinnormal limits: Spleen.Heart, Test4ls!EpididysisP,rostate,Stomach, Urira,@yBladde!,,Adrenal,Thvrci-.1T,rachLa. Esep@.&gLS,Si!ivary Pituita!-yP,an,,reas. --------------------------------------------------------------------------------------------- Anita!Nus:E-:IF-I.iB4 Sex: Nile Group: 6) FC-143 30 ppe Fite: (keekz1061TerminalSacrifice hicroscap4lOcbservations: N@acrosr.oniO,b"servations: Adrr;al Hiarl, Kidney 1.@.ver Lur,g Sil;Avarygland -No visiblelesions. -Sinusaidalectasia,-crtex,mild -Ddc:arditis,chronic,diffuse,marked -Chronic prrgressivenephrop&*Lhye,i'ad Pelvicsineralizitiosni,ld -Portalsononacleacrellinfiltratem,ild Portalbileductproliferations,ild -Vas:ulirsintiriliziitiao4n&,ld Alveolarmacrophages,oulti4ocil,sild -Sialidenitisc,hronic,moderate The fellomipgtissuesotre found to be withinnormallisits: Spleen,Tes'6istEp-id-.dyPsrioss,tate,Stomach,Urinaryfladder,Thyroid,Parathyro4adT,rachea, Esophagus, P@a+uitary,Pancreas. -- ------------------------------ ----- -- -- -- --------- - --------------- Animal Nutber: IR-3685 Sex: Halt Group: 6) FC-143 30 ppe Fate: (Weekz 1041 Si:ri4icedin extres@as MacroscopicObserveiocs: Skin Pituitary -Raisedulceratedlesionon left hind foolk-;ad. -Smalldirk area. MicroscopicObservations: Kidney -Chronicprogess4ve nephropathy,sin4.ti, Pelvic mintr&14'Azatiomni,ld Liver -Portalsoponuc!varcell infiltrate,m:ald Lung -Vas-.ulirm4Aneral,.-,itioen-,&"Ad Pituitary -Ade-ioma Prostate -Prostat;ktiasc,ute,mild Si!ivaryBlind -Not exisined,missing Skin -Podeder"t-.tiusl,cerative",fktd - - --------------------------------------------- - -- --- -- -- - Species: Rat Project Number: 0281CROO12 Swearized STAR Page: 178 342 Suseiri:edSingle TabulitedAnita!Report (continued) IndividualMacroscopicand HicrL%scopiOcbservatiOrs Riker LaboratoriesI,nc. IN FC-143: Two Year Oral Toxic@ty-on-.DgeniciSttyudy in Rats Table: ----------------------------------------------------------------------- ---------------Animal Number: IR-1@685 Sgx: mile Group: 6) FC-14330 ;p2 Fee: tweeks104)Sicrif;Aceidn extres@&S Mi.-roscc;-iZcbservation(scontinued): Tes'@;as/Ep-adidysis -Tubuleatrophy,aspersategenesisu,n4.1ateral, @,irked The fc!14@m;ntgissueswere zoundto be'v;.thinnormallimits; Heart,Statich,UrinaryBladter,Adrenal,ThyroiluF,irithyraidT,rachea,Esorhagus,Spleen, Pir,:rfis. ---------------------------------------------------------------------------------------- Anisil Number:IR-3686 Set:Halt 6roup: 61 FC-!4@v30 ppe Fate: (Weeks106) TerminalSacrifice MacroscopicObservations: M4A,-rDscapiOcbservations: Kidney Liver -No V;Siblelesio.-.s. -Chrot4.p:rogressivene;ik:ro;i'Lm@iyl,d -Portalitananuclecaorl.1infiltratew,ild Cysli.c@d.edgeneratim, fatal, min4Asi'& hopit:cytoalterationv,acualated,faca',.p tary Bi:ivaryBland -Cyst,parsintreedii -Not examined,missing T,,Ie tiiSU=Swere-gU-dIC be Withirnormallig;ts: 5;1.eerP,ei-t,Lung,Tes+is!EpididytiPsr,ostate,S4.,oticUtrii,naryBladder,Ac+rralaT,hyroid, Eso;ha;us.P,licreas. - --------------- ------------ - ------------------------- A-ima' WL&I.-arI:P.-3687 Sex: "&lie Broup: 6) FC-!4'3v0 ppt Fate:ilkeekz98)Sacrificeidn extresis Macroscopic Observations: Thorax -Filledwithbloodtingedfluid. Heart Lang -Appearsenlarged -Possibleareasof consolidation. Liver -Mottledand possibleeDn;estiDn. Kidney -Paleand pitted. Testis/Epie-idyn-As -onetestisappearssmill. Hisentery MicroscopicObservations: -Nodularam ntericbloodvessels. Adrtinal -Corticalvacuolationl,ocalareas,marked Sinusa;adaelctatit,corliexm,oderate Heart -Myocardiaflibrosiso,ultifocals,ild Nyocirditisc,hroricnonsuppuritive, oultifocisli,ld -- ------ ----------- ------------------ ------------- ----------- Species:Rat Project Number: 0261CROOI'&' Suearized STAR Page: 179 343 SustarizedSingleTabulatedAnimalReport(continued) IndividualKaCrOSCOPicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FC-143:Too Year Oral Tovicity-oncogen4citSytudy in Rats ------------------------------------------------------------------AnimalNuaber:If-3607 Six: Na,4e Group: 1 6) FC-14'@3@0 ppe Fate:(Weeks 9a) Sacrificedin extres4As Table:2 - --------- Microscopic0'6,servatio(ncsor!tinued): Vidney i.iver i.Lirig Mesentery PancreacF-c.s4i,%.e Testis./Epi,6';idyais -Chronicprogressivenerhropithy,marked Pelvicsintra'.izatiooinl,,, -Portalea.-ionu-.cIeelalrinfiltrates,ild Por*6&b1ile duct proliferationa,-41d Cystaiddegenerationf,ocal,mild Repatczytevacuo'La'6-idoinf,fuse,sild -Vasculasrintralizaticsni,ld Alveolarsacrophiges,sult@&4oca'c*-,.1d Atilt-tisis,diffuse.m.e4@eralle Pneumoniai,nterstitia!, localareas, moderate -Polyarteritimsa,rked -Not examined,aiss4kcg -Not examined,not in planeof section -Not examined,missing -Tubuleatrapty,aspers&'Logentsimso,derate Polayarteritimso,derate Loyti.c9iillhyperplasiaf,ocal,moderate Granuloma,spermatic i.iefollowingtissueswerefoundto be oith4&nor&&!limits: SplatenS,tomach,Urinirfbladder,Thyro4adT,rachea,Esoptagus,SalivarvBland,Eye..P-atui'6i,-y. ------------------------------------------------ --------- ----------------------- A Number: IF-'@1682 Sex: Na!e Group: 6) FC-14330 pps Fate: (Weeks 891 Sicrif@&ceidn extresis r.acroscc;iOcbservations: P41t@;il6a,-y -Enlargeddue tc raised! ca d;&a.mass. Thyroid -One thyroidappearedsl-aghtletnylarged. Liver Kidney -slightlpyall -Falaeand slightlyenlar-,-ed. Testis/Epididysis -Appearsmall MicroscopicObservations: Adrenal -Sinusaidaleci.-as,c&o,rit,ex,sild Kidrey -Chronicprogressiviee;hropithys,oder;'Le Liver -Nepatccytevacuo!atic.-l,ocalareas,t..;I&d Necrosis,Ice&&areas,ao,.Ier;,te Lung Parithyrcid -Vascularmi,.italizatio&n,,*&ld -Not exaa@4t-endo,t in plantof section Pituitary -Adencea Spleen -Nesosiderosis,ild -- ----------------- -------------------- ---------------------------------------- Species:Ral, ProjeclkNumber: O'llell@ROO12 Sumarized STAR Page: 160 344 Sumirized Single TabulatedAnimalReport (COntinuld) Individualftcroscopicand microscopicObservations RikerL&bO.'ItoritIsn,c. 3H FC-143:Two Year Oral Toxicity-oncoglnicitSytudy in Rats Table: 2 ------------ ---------------------------- - --------------------------------- ------- Arisal Number: 'AN-3608 Sex: Male Group: ( 6) FC-14'@3'0 ppe Fate: (Week= 89) Sacrificedin extresis MicroscopicObservations(conlk-inued): Testis/Epidi,UIYI'ls Tt.yro4d -Tubuleatrophy,aspertatagenesisb,ilateral, sild -Falliculahryperplasiic,ystic,unilateral,, marked Ultitabrinchi,ciylst The fD?IDWingtissues mere faun-WtIo be within normal limits: Heirlu,Prostate,Stosich,UrinaryB?adder,Trac@.ta,Esophagus,Salivarygland, Pancreas. ------------------------------------------------------------------------------------- Anisal Number: IF-7v68; Sex: Male Group: 6) FC-143 30 pps Fate: (Week=106)Teraina!Sacrifice MicroscopicObservations: M41crosr,.;@&Ocbservations: Adrena'L V.id-.iey Lung Pirathyraid pi&L;4ary .6 A6 Thyroid -No visiblelesiois. -Fbeochrooozytosab,enign,unilateral -l.hron-&p*rcogress@ivenephropal.by,a;&Id -Fetal sonoilcltacrellinfiltrates,il46 Portalbile ductproliferaticim,ild -Vascular mineraliza4Lionm,ild -Not examined,not in plane c4 section -Not examined,missing -C cell adenoma The f:llowi-gtissueswere fou,,!t.odbe NAth4inor&&'limits: Sp-lean,Hei-t, 7#stistEpid;adyiiPirso,state,BluosachU,rinaryfladder,Trachea,Esophagus, al;4va?-eyaa!td,Pancreas. --------------------------------------------------------- ---- - ------------------------- AiiiialNumber: IR-3690 Sex: Male Group: 1 6) FC-14330 ;ps Fati: (Week.1=06) TerminalSacrifice MicroscopicObservations: Testis/Epididysis MicroscopicObservations: Adrenal Heart Kidney Liver Parathyroid -Left testissomewhatsmall. -Sinuscidale-.tasiac,ortex,minimal -Hyrcarditis,ch.-aninconsuppurative, localareas,sild -Chronicprogressivenephrop&tey,sild -Portalsoponucleacrell infiltratem,il.d kgalocytcsis,minimal -Not examined,not in planeof section Species: Rat Project Number: 0201CROO12 Sunarized STAR Page: 161 34 SummarizedSingleTabulatedAnimalReport (cortinuid) IndividualMicroscopicand MicroscopicObservations Riker LaboratoriesI,nc. 3H FC-143:Toe Year oral Toxicity-ontogeniciSttyudyin Rats Title:2 ----------------------------------------- -------------------- --- --------------------- AnimilNumber: IR-3690 Sex:Mile Broup: 6) FC-14330 ppa Fate: (Weeks106) TerminalSacrifice MicroscopiOcbservations(continued): P;Itu4ta-Y Testis/Epididyais -Cist,pars inte,sedia -Tubuleatrophy,aspereatogenesisu,nilateral,, marked. T@,le t4ssues*ere foundto be will.@niorr,mallimits: Spleen,LLn;@Pros*ate,Stoaa:h,UrinaryBladder,Thyroid,Trachea,Esopha;us,Sa'iviryclain@l, Panc.-eis. - ----------------------------------------------------------------------------------------------- Ar.;AaaNiumber: Sex: Oile Group: 6) FC-14'0310 pps Fite:(Weekz106)Tere@.naSlicrifice Ma:ros:c,,i'.Ocbservations: MatiarySlar!d Observa'6ions: HEirt K44dney Liver Lung Pancreas Pariithyroid Skin -Subcutaneouso,ultilobl-lmiarss,5.5 x 4 x 5 ce, -Myocardiaflibrosis,locilareas,mild Mycearditisc,hronicnonsuppuri'6ive, aulti4ocals,ild -Chroni,p.rogressivenep,@ropithye,i.d Pelvic mineralizations,ild -Pa.-tislonmuclearcell in4iltralea,-@ld -Vascularmineralization&,4.11 -Ac4snaratrophy,minis&! -Netexamined,not in planeof section 4ibrosarcca'a.subcutaneous The folglow4atni,s,sues were foundto be wittinnor&&'l,imits: Testi.slEp@&didysP@rso,state,Stcatch,UrinaryPlidder,Adrenal,Thyroid,Trachea,Esopligus, Sa*ivaryeland,PituitaryS,piten. __:------------------------------------------------ ----------------------------- Aniaal Nueber:IR-36914 Sex: Mile Br:up:( 6) FC-14330 ppe Fi'@e:(Week--106)Tere@&nalSacrifice N116-'OSCOPiOCbSefyatiODS: RicrDs:opicObservations: K-A*driey Liver Long Pituitary -No visiblelesions. -Chronicprogressivneephrepithyg,ild -Portilsonanucleicrellinfiltratem,ild -Yas6-ulasrintralizatiosni,ld -Adenagi The follooointgissueswere found to be with-&n*onr&&!limits: Spleen,Heart,7#stis/EpididymiPsr,ostate,Stomach,UrinaryBladder,Adrenal,Thyroid, ------- ----------------------------------- ----- - -- ----------- Species:Rat Project Number: 0261CROO12 Summarized STAR Page: 182 346 SummarizedSingle TabulatedAnimal,Report (CCII'.ir-uld) Individual MacroscopicAnd Hicrogco;icobservations RikerLaboratoriesI,nc. 3n FC-1143T:wo Year Cril Tcxicity-orcog@nicitSytud-fin Rats Table:"I ---------------------------------------------------------------------------- ---------- Anizal Number: IR-U92 Six: Male Group: ( 6) FC-14330 pps Fate: (Week= 106) Terminal Sacrifice Mi:ros,,oOpbiscervatio(ncsontinued): The fc!!Ow-.'nt'isss,.,ewsere found-to be within normal heits (continued): Parat@.yro.d,Trac@ea, Es.-pillaguSsi,l@vary Gland, Pancreas. ------------------------------------------------------------------------------------------------ Aniaal Nu:ber: !R-71693 Sex: Mile Fate: (Weeiz106) Ttra4AnalSacrifice Group: 1 6) FC-143 30 pps Microscopic Observat4ions: Skip. Liver Microscopic Observatiors: Adrenal Heart Kidney ..Yer Lu7,,, Pi-icreas Salivary Gland Skin -Raisedulceratedinfliesedlesion,ri;h" hin'. footpad. -Appairs settled -Cor,6ical.41;eneratiorf.e,cal, goderite Phear.hrosocytesib,en@ign,bilateril -Myocarditis,chronic nonsuppura'6ive, aultifocal,aild -Chron4acprogressive nephropithy, moderate Pelvic miner;lization,moderate -Portalemmuclear cell infiltratea,ild Portalbile duct proliferations,ild Cystoid degeneration,oultifocal.s,ilad Hopatocyte alteration,vacuolited,focal., mild -Vasculair sintralizatim, o46ld Alveolar sic.-ophages, oultiiocala, sild Hoserrhage;sul'Lifocals,ild -Acinar atrophy,sild -Sialit-initisc,hronic,moderate -Podadereatitis,ulcerative,@irked The fO'A"D*iftgissues were found to be within fiormillimits: Spleen, Tes'644.s,EpididysP'rso,state, Stomach, Urinary fladder, Thyroid, Parathyroid,Trichea, Esophagus, Pitu4@tary. ---------------------------------------------------------------------------------------- Animil Number: IR-74694 Sex: Kale Fite: ikeka 106)TerminalSacrifice Group: ( 6) FC-143 30 ppe Macroscopic Observations: Pituitary -Reddish miss, 0.5 ce dia. Microscopic Observations: Adrenal -heochrosocytota,benign, unilateral Kidney -Chro,.iipcrogressive nephropithy,mild ----------------------------------------------------------------------------------------- Species: Rit Project Number: 0281CROC12 Summarized STAR Page: 163 347 SuesirizilSingleTabulatedAnimalReport (continued) IndividualNa:roscopicand Microscopicobservations RikerLaboratoriesI,nc. 3P. FC-143:Too Year Oral Toxicity-OncogenicitSytudy in Rats Table: -- - - - -- - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - Anisal Number: IR-3694 Sex: Halt Group: 6) FC-14330 ppi Fate: (Week=106)TerminalSacrifice r.icrescop@OIbcservations (continued): Liver Lung Fin:reas Pituitary -portalsoranucleacrellinfiltratem,ild Portal bilatduct prol4&4eraticro.-,'*Id -Alveolarsacr:)phagesm,ild -Pypirplasiai,sle'c.ell,nodular,sild -Adencei The follow@&ngtissues were found IL-bce within normal limits: Splee,.iH,Eirt, TestAs.,Epid4ady&4Psr,ostate,Stomach, Urinary Bladder,Thyroid,Parathyrcid, Tra.-hea.1--so;klagiSsa,laivaryBland. -------------------------------------------------------------- -- ------------------------- An-;&a'N,Leber: IF.-3695 Sex: Ma',e Broup: 6) FC-143 30 ppi File: (Week=10'0)TerminalSacrifice MacroscopicObservations: Mi,,roscop4&Ocbservations: Adrenal Esophagus Heart Liver Lur@; Pituitary -No visiblelesions. -Medullarycell hyperplasiaf,ocal,mild One of pair present -Not examined,missing -Myocarditis,chronicnonsuppurat-ave, aultifocalm,ild -Portalmononucitacrellinfiltrates,ild -Vascularmintralizatim,mild Pneuvotlia,,interstitciharlo,nic,focal,mild -Not examined,gigging The followingtissueswere foundto be vithinnormallimits: Spleen,Kidney,Testis/Epid4.dysiPsr,ostate,Stomach,LirinaryBladder,Thyroid,Parathyroid, Trachea, SalivaryGland, Pancreas. -------------------------------------------------------------------------------------- Ar.4@ilNuaber: IN-4706 Six: Fisale Broup: 6) FC-143 30 ppe Fite:(Weekz 72) Sacrificedin extresis MacroscopicObservations: Mammary Bland -Large ulceratedmass,1.5 1 3.5 ce dia. in left inguinalarea MicroscopicObservations: Adrenal -Sinusaidil ectasiac,ortex, minimal Kidney -Chronic progressiveneph,apathy,min4amal Liver -Nesatopoitsise,xtrandullary,mild Lung --- --- ------ -Vascularsintralizationm,inimal - -- ------------------ ------------------- ----- --- ------ ------- Species: Rat Project Number: 0221CROO12 Sunarized STAR Page: 184 348 SumarizedSingleTabulateAdniul Report(COn6inuld) IndividualMacroscopicand MicroscopicObservations RikerLabo,itariesI,nc. 3H FC-143:Two YearOral Toxicity-oncogeniciSttyudyin Rats --------------------- ------------- ---- Table:2 - ------------- --------------------- AiisalNutloerI:P-4706 Six: Female Group: 6) FC-14T.30 ppe Fate:(Week=71.)Sacrificeidn extresis Microscop:Ocbservations(continued): Himetry 61and Pancreas Paral,@.yro4ad Pitui,6ary 0.plee-, -Adenecarcinota -Acinaratrophy,minimal -Notelao;ine-nUo@t, in plane0- section -Adencoa -Hesatepoitsise,xtrasedL.Ilariyn,creased, sa!,k.ed The iollow4&nt;issueswere foundto be within-,iorelai'mAits: Hea-t,Ute.,,.O,vsa,ry,Stasict,UrinaryBladder,Thyroid,Trachea,Esophagus,SalivaryBland. ------------------------------------ - ------------ ------------------------------ AnimalNuabe-: !R-4707 Sex: Female Group: 6) FC-14330 ppe Fate: (Week= 90) FoundDead MicroscopicObservations: Mammary Gland Pituitary MicroscopicObservations: Adrenal Kidney Mammary Gland Ovary Parat.hyroid Pituitary -Largecysticmass,6 x 4.5 x 2.5 ca, fi',Ied withblood,inperintalard right inguinala-gas. -Hemorrhagilcesic-,1,.5x I ce. -Sinuse-dail.-tasiac,ortex,oild -Chronicprogressivenophropat@y,mild -Adenocircinosi -Withinnoreillimits One of pair present -Not exagired,not in planto@ section -Adencia The fr.!'Aowitni;ss@.iswerefoundto be withinnertillimits: Sp*&eer.L,iver,Heart,Lung,Uterus,Stomach,UrinaryBladdt-,Thyroid,Trachei,Esoptagus, SalivaryElaid,Par,:reas. ----------------------------------------------------------------------------------------- Animal Number:IR-4708 Sex: Female Group:( 6) FC-1437.0ppe Fite:(Weekx105)TerminalSacrifice fli:rcscap4Osbeservations: Pituitary -Raisedmass,0.! co dia. Rassary Gland -Smallnodl!armass,I ce dia.,in left &Kill&;largeBass,5 1 1 x 3 ce, in rightinguirialrt&. MicroscopicObservations: Adrenal -Sinusaidaalctisia,cortex,moderate - --------------------------------- -------------------- Specits:Rat Project Number: 028!CROO12 . Summarized STAR Pave: 111 349 SummarizedSingleTabulatedAnimal Report (continued) Ind4aviduaNllcrostopicand HicrostapitO'bservations RikerLaboratories,Inc. 3H rc-14"'iT:wo Year Oral Toxicity-OncOgenicitSYtudy in Rats --------------------------------- ---------------------------Animal Number: IR-4708 Six: Female Broup: 6) FC-143 30 ppe Fa'6e:lneekm105,1Terminal Sacrifice Table: 2 MicroscopicObservations(continued): Mammary Gland Para'6byroid Pituitary Uterus -Fl7broadencei -Not examined,not in plane of section -Adenama -Cysticglands,moderate The followin;tissueswere found 411b)e withinnormal limits: Splee.nL,iver, Kidney,Heart, Lung, Ovary,Stomach,UrinaryBladder,Thyroid,Trachea, Esop,@agis,Si'AivaryBlind, Pancreas. ------------------------------------------------------ ------ ------------------------------ Aniai! Number: IR-4709 SeK: Female Group: filFC-143 30 pps Fate: (Weekx 99) Sicri4icedin extresis hicroscr,piOcbservations: Pituitary Abdomen (internal) L@aver M44croscupicObservations: Adreiial Kidney Liver Lung Mammary Blind Panc-eis Pirathyraid Pituitary Spleen -Enlarged,0.7 ce dia. -6&strointtstinatlract distendedmit,@gas. -Yellowishfocal lesion,0.1x 0.3 CA, in fissureof medianlobe; liverpossiblyslightlypale. -Siftusaidaelctisia,cortex,&irked -Pelvicaintraliz&4.iosriil,d -Portalsonanucleacrellinfiltratem,ile Hep,itacyt&e!teration,vicualited,fop.ii, marked -Vascularlintrilizatiowri.l,d -Bilactacele -Not exao;tnlds,issiig -Not exas@.nedn,ot in plant of section -Adenota -Nesitapaitsise,xtrasedullaryi,ncreased, sild The felloningtissueswere foundto be withinnormallisits: Heart,Uterus,Ovity,Stomach,UrinaryBladder,Thyroid,Trichei,Esophagus,SalivaryBland. ----------- - --------- --------- ----------- ------------------------- Species: Rat Project Number: 0201CROO12 Smarized STAR Page: 186 3 5 0 SummarizedSingleTabulatedAnisilReport (continued) IndividualMacroscopicand MicroscopicCbsrvations RikerLaboratoriesI,nc. 3m FC-143:Two Year Ural Toxicity-oncogenicitSytudy in Rats Table: ----------------------------------- -- ---------------------------------------- AnimalNumber: IR-4710 Six:Fesile Group: 6) FC-14330 ppe Fa,Le:(Weeks105)TerminalSacrifice MicroscopicObse-vitions: Fi*6uitary Adrenal Lun; Mimma,y Blind Ovary Pirathyro;.d Pituilary Lllkeru; -Hisarrhagim:ass,0.6 ce dia. -Lar;eoulitilobulmaarss,9 x 7.5 1 lei'.inguinalarea. ce, in -Sinusaidaelctasia,cortex,marked Corticaldegenerationm,oderate -Vascularmineralizationm,ild -Fibroaderosa Extensivenecrosisof tueor. -Cyst -Notexamined,not in planeof section -Adenosa -Cysticglands,earkel Ltioeyosa Tl,lfeolalow;atiigssueswere four.,t.o'be withinnor&&]limits: Spleen.Liver,Kidney,Heart,Stomach,UrinaryBladder,Trachea,Esophagus,SalivaryBlind, Pa.^,creiTsh,yrDid. -An-i-m-il-tN-u-i-lu-e-r-:I-R--4-7-1-1 ---S-e-x:-F-i-s-a-le--G-ro-u-p-:--6-)-F-C--1-4-3-30--pp-e-----------------------------------------Fi46E:(Week=105) TerminalSicrifice MicroscopicObservations: AaceiryGland MicroscopicObservations: Ad-inil Kidney Liver Lung Rameary Blind Pituitary Spleen -Large@ass,10 1 10 1 4 ce, in righ', inguinaliperineaarlea. -Corticavlacuolitionl,ocalareas,mild -Chronicprogress-Avneephropathy,mild Pelvicmintralizatior@.;,.Id -Hapatocytveacuolitiono,ultifocals,ild -Vascularsineralaizatiomni,nimal -Fibroadenzaa -Adenoss -Helatopciesise,xtrisedullaryi,ncreased, moderate Thefollowintgissueswe foundto be withinnortallimits: Heart,Uterus,Ovary,Stomach,UrinaryBladder,Thyroid,ParathyroidT,rachei,Esophagus, SalivaryGland,Pancreas. --- ------------ --------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page; 107 3 5 1 SummarizedSingle TabulatedAnimal Report (cont4.nued) IndividualMacroscopicand microscopicObservations Riker Laboratories,Inc. FC-14'v'T:wo Year Oral Toxicity-oncogenicitSytudy in Fats Table: 2 ------------------------------------------------- ----------------------------------- Aniaal Number: IR-4712 Sex: Female Group: 6) FC-143 30 ppR Fate: tkeetz 94) Sacrificedin extromis macroscopicobservations: Pituitary HistaryBland Pancreas Mi:rcscopO4bsce-va'6io:,.s: Adrenal Kidney Liver Lung nalsiryGland Ovary Pin:reas Pituitary UterLs -Hitorrha;iacass,I.'.x ca. -Cysticsultilabularmass,5 x 5 x 3 re, in leftin;u;knaalrea,filledwithdark fluid;smallcystic&ass,2 x I ce, in rig@t inguinalarea. -Small nodule, O.'qc@a dii. -Sinusaidalictisia,cortex,moderate -Nyocarditit,chronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropathy,minimal Pelvicmineralizations,inimall -Portilsononucleicrellinfiltrates,ild Portalbileductproliferationm,ild -Vascularmineralizationt,ilad Alveolarmacrophiges,ouAtifa-.als,ilad -6&lactocele Adenocarcincei -Cyst -Islet celladenosa -Aderona -Cysticglands,moderate The fe's'Lowitrigssueswere found to be withinnormal limits: Spleen,Stomach,UrinaryBladder,Thyroid,Parithyroid,Trachei,Esophagus,Salivaryslind. ---------------------------------- ------ ------------------------ ----- --------- Animal,Number: IR-4713 Sex: Female Group: t 6) FC-14330 ppe Fite: (Week= 97) Found Dead Kacros,@op4aOcbservations: Liver Uterus -slightlpyile -Leftuterinehar-,hias smallclearspherical mass,0.5 ca dia.;rightuterine .horn greatlyenlargedand filledwith dari bloodyfluid. MicroscopicObservations: Liver -Portalsonanctlearcell infiltrate,o@tld Necrosis,sulti4ocal,mild Lung -Vascularmineralizationa,'Ald Lymph Made -Hyper;lasia,reactive,moderate HisairyGland -Not examined,missing - --------------------------------------------------------------------------------- Species:Rit Project Number: 0281CROO12 SamurizW STM Page: 189 352 Sunarized Sin;leTabulatedAnimalReport (continued) Individualnacroscaoicand hicrdscopicObservations RikerLiburitarigsI,nC. 3h FC-143:Two Year Oral Toxicity-oncogenicitSytudy in Rats Table: 2 -------------------------------- ------------------------ - --------------------- Anisal Number: IR-4713 Sex: Female Broup: 6) FC-143 30 pps Fate: (Weekz 97) Found Dead NizroscopicObservations(-ontinued): Pitui'6ary Spl,te-, Uterus -Adenami -hesitopoitsise,xtrosedu'Alariyn,creased, mild -Cysticglands, marked Hosangicaa The tissueswere fc--intdo be withinncrtallimits: Heart, Ovary, Stomach,UrinaryBladder,Adrenal,Thyroid,Parathyro;aeT,rachea, Sa!4&varyglind, Pancreas. ------------------------------------------------------------------------------------------- An4,aalNumber: IR-41'14 Six:Female 6roup: 6) FC-143 30 ppe Fite: (Neekz105) TerminalSacrifice Macroscap;cObservations: Mammary 61and Lymph Mode (ibdominil) Nir.roscepiOcbservations: Adrenal HE-ar'@ Kidney Liver Lur.g Haosary Blind Pancreas Spleen Uteri;s -Nilkcyst,liftasilla;largemiss.8,.5 x 7 x 4 ce, in leftinguinalarea. -Renal lymph nodes enlarged. -Sinuscidalectasia,cortex,moderate Adenosa,cortical Tumor describedas enlargedrenal lymphcode at necropsy. -Myocarditis,chronicnonstlppurative, oultifocals,ild -Chronicprogressivenephropathy,sild -Negalocytosis,minimal -Vasculip- sintralizatioi, a,'41.1 -Fibroadinama 6&!actocele Adenocarcincei -Not examined,missing -Hesitapoitsise,z'Lramedulliryi,ncreased, a4Ald -Polyp The followingtissueswere found 46a be within nermal li'iits: Ovary, Stomach,UrinaryBladder,Thyroid,Parathyraid,Trachei,Esophagus,Salivary Bland, Pituitary. ---------------------------------------------------------------------------------------- Species: Rat Project Number: 0291CROO12 Sumriztd STAR Pap: 189 353 SumeariztSdingleTabulateAdnimaRlepor(tcontiftued', IndividuaMlacroscopiacndhitrolt ic observititms RikerLaboratoriesI,nc. 3H FC-143:Two YearOral Toxicity-OncogeniciSttyudy in Rats Table:2 --- --------------------- - ------------------------------------------------------------ Animal Number: JR-4715 Sex:Female 6roup: 6) FC-147.30 ppe Fate: (Weeka1051TerminalSacrifice microscopicObservations: MicroscopicObservations: A-ulrenal Heart Kidney Liver Lung Ovary Pancreas Parithyrnid Pituitary S;Ieer -We visib'aleesions. -Sinusaidalectasia,cortex,unilateral, marked -Kyo-,irdi'6cihsr,onicnonsuppura'6ive. oultifocals,ild -Pelvicaintralizitiomno,derate Polyarter44timsi,nimal -Repatacytveicualatiato,ultifocalm,inima' -VAsculas-intrali.,atiaoinl,d -Cyst,unilateral -Polyarteritimsi,nimal -Not exaained,no'&i.n plantof section -Adencii -Hosas@aderosiss,ild The icliraingtissues*erefourdto be withinnormallimits: Ul.'eu's, Matury SlanluS,tomach,OriniryBladder,Thyroid,Tric.4a,Esophagus,Salivary6'Aand. ------------------------------------------------------------------------------------ AnimilNumber: IR-4716 Sex:Femile 6rou;:t 6) FC-14330 pps Fi+e: (Weekz105)Tera'anaS,i'c,rifice MicroscopicObservations: Skin Hicrostc;iOcbservations: Adrenal Lung Ovary Pituitary- -Hairthinningon head. -Sinuscidielctisia,co-tex,marked Corticildegenerationf,ecal,sild -Yascularmineralizationm,inimal -Cyst,unilateral -Cyst,pars intersedia The followingtissuesare foundto be withinnormallimits: Spleen,Liver,Kidney,Heart,Uterus,MammarySland,Stomach,UrinaryBladder,Thyroid, ParathyroidT,rachea,Esophagus,SalivaryBlind,Pancreas,Skin. ----------------------------------- - ----------------------------------------------- Species:Rat Project Number: 0281CROO12 Sussa.,izipSdTAR Page: 19C 354 Sumarized SingleTatulitedAnimalReport (continued) IndividualM&Crcscdpitand micr6ttooicObservations RikerLaboratoriesI,nc. 3H FC-14-@Ttw:o Year OralToxicity-oncogenicitSytudy in Rits Table:2 --- ----------------------------------------- ------------------------------------------ AnimalNueber: IR-4717 Sti:Femile Group: 6) FC-14330 ppe Fate: (Week=IC*51Teraini!Sacrifice Hicros.po;iO:tservations: P@,4u;"ary IM.1calsrlyanam Adreni! Mi.erosce;@0,1,,,sevitio,,s: Acre;al K4dr.ey Liver Lung MassiryGland Pituitary Uterus -Hemorrhagicmass,I ce dia. -Lobularmass,4 1 3 1 2.5 ct.,in leftizilali; Cysticlobl.!aBrass, 2.51 2 1 1.2ce, in perinealarea. -Leftadrenilenlarged. -Sinusc@daelctisis,cortex,marked Enlargemenotf leftadrenildue to massive sinuscidieicltisia. -Chronicprogressivenephropithy,minimal Pelvicaintralizationm,oderate -Nepatacytevacuola,@ioonu,ltifocal,Gild -Vascularsintraliza4uiosni,l-I Alveolareacrophiless,ultifocali,iild Riaorrhagel,ocal areas,moderate -Fibraideni)iia SalaCtKfle Adtnocarcinati -Adromi -Cysticglands,mild The fol"omin;t4ssueswere foundto be withinnormallimits: Spleen,Heart,Ovary,Stoaa:,%U,rinaryBladder,Thyroid,ParathyraidT,rachel,Esop@agus, Sila;avarGyland,Pincreas. -------------------------------------------------------------------------------------------- An-&oilNumber:IR-4716 Sex: Female 6roup: 6) FC-14Z30 ppe Fate:(Week= 94) Sacrificedin extresis Ricroscop44Ocbservations: Pituitary RattiryGland Adrenal Kidney HicroseapicObservations: Adrenal Esophagus Kidney Lung -RaisedBass,1.3ce dii. -Cysticeast,4 x 3 ce,leftaxilli;silkcyst in the perinealarea. -Rightidrinalenlarged. -PossiblyPalo -SioLsoidaelctisia,cortex,marked Enlargementof rigi@tadrenaldue to massive sinusoidalectasia. -Not examined,missing -Chronicprogressivneephropithy,minimal -Hmrrhage, local areas, sild Pneumonia,fortignbody, localareas,marked - ---------- Species:Rat Project Number: 0291CROO12 Sumarized STAR Page: 191 355 SummarizedSingleTabulatedAnisilReport (Continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Too Year Oral Toxicity-oncoginicitSytudy in Rats Table: 2 -- ----------- ------------- -------------------------- ---------------------------------- Animal Number: IR-471B Six: Female Group: 6) FC-1&4'3)0 ppe Fate: (Weeks 941 Sacrificedin extresis MicroscopicObservit4.ons(ca,-.t4&nued): Mazaa-y Gland Parathyraid Piluuitar-i Uterus -F4&Ercadenosa Silactocele -Not examined,not in plane of section -Ade.-icei -Cysticglands,moderate The folAlaN@intgissues were found to be mitb4,normallimits: Spleen,Liver,Heart,Ovary,Stomach,UriniryBladder,Thyroid,Trachea,SalivaryBlind, Pancreas. -- ------------------------------------------------------------------------------------------ Anisil Number: IR-4719 Sex: Fesile Group: 6) FC-143 30 ppe Fate: iweekz 96) Sacrificedin extre&4s Macroscc:itObservations: Eye Pituitary Soft Tissues (ner.,k) Liver Kidney MicroscopicObservations: Adrenal Eye Kidney Liver Lung HisairyBlind Oviry Parit@yraid Pituitary SalivaryGland Spleen -Left eye dark, possiblehemorrhage. -Small hemorrhagiclesion. -irregularcysticsubcutaneousmass, 6 x 4 1 2 ca, in neck art&,possibly mammary gland or sa!ivarygland. -slightlpyile -Slightlypale and pitted. -Corticalvacualition,local areas..soderi,'6e -Kerititis,acute,ar,-4'la+.e&riar'kAe,d -Chron4atprogressive nophropathy,e;.14d -hepitocytevacualation,diffuse,silsd Nepatacytealteratien,basophilit,fecal, tild 4etcrrhage, localareas,marked metastaticneoplasm -Adenocareincei -..,^SVt, unilateral -Not examined,not in plane of sectic.,t -Adenani -No4 examined,siesing -Himasiderosis,moderate The followingtissueswere found to be within normallimits: Heart,Uterus, Stomach,Ur@nary Bladder,Thyroid,Trachea,Esophagus,Pancreas. - - -- - --------------------- ---------------- --------------- ---- ------ Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 192 356 SummarizedSingle TabulatedAnimal Report (rontinued) IndividualMicroscopicand Microscopicobsiirvat4.cfts RikerLaboratoriesI,nc. 3" FC-143:Two Year oral Toxicity-oncogenicitSytudy in Rats -------------------------- - ------------------------------- ------AnisalNumber: IR-4720 Sex: Femile Group: 6) FC-14330 ppe Falh.e(:keek=105)TertinalSltcrifice Table:2 macroscapi,a@bsf?vitic.-ts: Rastaryslan,( M;Acroscap4@cObserv&164&ons: Ad-e.^@al K@.dney Liver Lung Magearyelan! Faccreas P4t:;4.tary -6ss in r4Ag@tinguinalarea appearsto be in4gamed milkcyst. -Sinusaidaelctasia,cortex.marked -pelvicsineralizatiogni,ld -Hopatocytovicuolationo,ull@ifa,.amli,lid Hepatacytealteratiorv.i,icuclatefd,ocal, aild -Alveolareacrophigeso,ultifocals,ild Perivasculasronanucleairnfiltratem,ild -Adenocarcincea -Acinaratrophy,saderite -Adenosi The follom:lntgiSSLIS*erefound4o be withinnormallimits: Spleen,Heart,Uterus,Ovary,Stomach,UrinaryBladder,Thyroid,ParithyraidT,rachea, Esophagus,SalivaryGland. -- ------------------------------------------------ - --- ----------- AnimalNurijer:IR-4721 Box: Fesele Group: 6! FC-14330 ppe Fate: (Week= 95) FoundDead Microscopicnbservit4sors: Mammary Si.and Uterus Micros-zpicObservations: A.'renalt Liver massi,ySland Ovary Pancreas Parithyraid Pituitary SalivaryGland Spleen -Mass,8 1 7.5 x 3.5 ts, oultil.ob-.-rliagr,,'-.t inguinalarea;oultilebulamrassin leftinguinalarea. -Hemorrhagiclesion,0.7x I co,leftuterine horn. -Sinusoidia!ctasia,cortex,moderate Nesitapaitsiesx,tramedullaryc,ortical, marked -Resitapaitsise,xtrasedullarym,inimal -Fibroadenosa Ader.ocarcinoma -Withinnormallimits one of pairpresent -Not examined,missing -Notexamined,not in plantof section -Notexisimd, missing -Not examined,missing -Nmtopoits46s,extrisedullaryi,ncreased$ &irked ---- ---------- -- ----- - -- -- ------------ ------ species:Rat Project Number: 0281CROO12 Sum rized STAR Page: 193 357 SummarizedSingleTabulatedAnimalReport (continued) Individual Microscopicand Microscopicobservations RikerLaboratoriesI,nc. 3" FC-143; Two Year 0-al Toi@icity-OncogeniciSttyudy in Rats -------------------------------------------- --- ------------------Anisal Number: IF-471&1 SIK: Female Group: 6) FC-141.30 ppe Fite: (Neekz 9!1 Found Dead Table: 2 - ---------- MicrosccpicObservations(continued): Uterus -Neserrhage,fcci!,sucasallm,ild -Polyp The ia'Alomint-;,.ss!jewsere found to be withinra-mallimits: Kid,-,e-Fte,ar", Lung, Urinary B"idder,Thy;.@id,Trachea,'Esophagus. ----------------------------------------------------------------------------------- Ar.,ai'4Nur-ber: IP.-47'@@2 Sex: Female Group: 1 6) Fl,'-143'0@@p'pe Fite: (k2Ek= 831 Found Dead Mi:rcsc@picObse-vations: N&Agiry 61and Liver Pituitary licres@60p@ic Adrenal Liver Lung P@amma,y Gland Pituitary Salivary61and Skin Spleer. Uterus -Largtnecroticmass, 11 x 8 x ax4llaryregion. ca, left -Hemorrhagic mass, 0.5 ce dia. -Sinusoidalectasia,cortex,moderate -NKrOSiS, $UltifOC&I,marked -Vascularmineralizationm,inimal Alveolarurrophagn, ou'AtifocaAm,ild -kt IK&Bintd, missing -Adenoss -kt examined,missing -Fibroma -Hositopoirsise,xtramedullaryi,ncreased, moderate -Cysticglands,marked The followingtissueswere foundto be withinnormal limits: Kidney,Heart,Ovary, Stomach,UrinaryBladder,Thyroid,Parithyroid,Trachea,Esophagus, Pancreas. -- ----------------------------------------------------------------------------------------- 4,-iisaKluaber: IP-4723 Sex: Female Group: 6) FC-143 30 ppe Fite: (Weekx105) TtroinalSacrifice MicroscopicObservations: Mammary Blind -Perinealmass appearsto be inflassedmilk cyst;largemass,9 1 5 1 2 cm, in throatart&. MicroscopicObservations: Adrenal -Sinusaidalectisia,cortex,moderate Kidnty -Nephrosis,tubular,moderate - --- -------- --------- ------------ --------------------------------- ---- - - --- Species: Rat Project Nu#ber: 0281CROO12 Snearizod STAR Page: 194 358 SummarizedSingleTabulatedAnimalaReport (continued) IndividualH&Crostapicand MicroscopicObservations RikerLaboratoriesI,nc- 3H FC-!43:Tut)Year OralToxA4citY-OncOgen4citSYtudyin Rats Table:4" - -- - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - . . . . . . . - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - AnimalNumbe-: IR-47"L3 Sex: Female Sroup: t 6) FC-14'.3@0 pps Fate: (Week=105'TerminalSacrifice MicroscopiOcbservations(continued): Lun; Kar.&aryGland Ovary P4tuitary Literus -yascu,armineralizationm,inimal -Adenotarcinceap,aipi!lary -Tubularhyperplasiam,oderate -Adenosa -Cysticglands,marked Hyperplasite,ndametrialp,apillary,ioderal,c- The fo!irnirgtissdeswerefoundto be withinnormallimits: Spleen,Liver,Heart,Stomach,UrinaryBladder,Thyroid,ParathyraidT,rachea,E5opha-,ui, SalivaryBlind,Pancreas. -------------------------------------------------------------------------------------- Anima'aNumber: IR-47144 Sex:Fesile Group: 6) FC-14"1'4@pCps Fi46t:(WeekzIV@)TerminalSacrifice MacroscopicObservaluions: Small,Intestine 'U'slel.,- vat;..ris: Kidney Liver Lur.g Lymph Made Mammary Gland ovary Parathyroid Small Intestine UrinaryBladder -Ulcerateo.u'tpouc@.infgilledmitt,ingestain jejunus. -Sinusaidaelctasia,cortex,mild Corticaldegenerationf,ocal,@4&ld -Chronicprogressivenophropithy,minimal Pelvicmineralizationm,inimal -Portalsononacleacrell infiltratem.i,ld Portalbili ductproli4tratiomri.l,d -Vascularm*ineralizationm,inimal -Hyperplasiar,eactive,moderate -Not examined,missing -Tubularhyperplasiab,ilateralm,ild -Notexamined,not in plantof section -Leiceyositcomij,ejunum Largeinfiltrativteumorwithou-,osaslurface ulcerated. -Not examined,missing The following'#.issu*eesrefoundto be withinnormallimits: Spleer,H,eart,Uterus,Stomach,Thyroid,Trachea,Esophagus,SalivaryGland,Pancreas,Pituitary. ------------------------ -- ---------- - ----- ---------- ----------- Species:Rat Project Number: 0281CROO12 SumearizodSTU Page: 195 359 SummarizedSingleTabulatedAnimalReport (Continued) IndividualNacrcsccPicAnd Microscopicobservations RikerLaboratoriesI,nc. 3H FC-143:Too Year Oril Toxicity-oncoginicitSytudy in Rats Table: 2 ---------------------------------------------- --- -------------- - ---------------- Animal Number: IR-47"5 Slx: Fesile Group: 6) FC-143 30 pP& Fate: (Week= 94) Sacrificedin extresis r.acros@,opiOcb-se.-vations: Pi4l.uitary microscopicObservations: Adrenal Kidney Pi,6,u4tary red mass, I co d4a. -Sinusoidalztasia,cortex,vild progressivenep.Nro;athy9,4.1d Pelvi-.minerali,.atiomni,nimal -Vascula,eirtralizations,ild Resorrhige,oultifocal,mild -Adenoma The tissueswere 4ound to be withinnormallia;.ts: Spl.ear,L,;,ver,Heart, Oyary, P@as2aryBland, Stomach, LiinaryBladder,Uterus, Thyroid, Fi.-at@yroid,Trarl@,leEas,ophagus,Salivary Oland, Pancreas. ----------------------------------- --- ------ - ------------------------------ AnisalNugber: IR-4726 Six: Female 6roup: 6) FC-143 30 pps Fal,e:(Week= 1051 Ters4AnilSacrifici! Hicroscap;aOcbservations: Pituitary Hameary Bland Microscap44cObservations: Adrenal Kidney Liver Lung Par,ithyroid P4,tuitary Urinary gladder -Hemorrhagic&ass, 0.6 co dia. -Smallmiss,appearsto be silk cyst,in thri:atarea. -S4nusaidi, ecl@as4&&c,ortex, moderate Nodular hyperplaasiac,ortex, eade,alut -Chron;.cprogressivenephropathy,&;,nisal. Pelvic mi'leralizalk,4m4i0ni,mal -Portalsononuclearcell infiltrate,minimal -Vascularmineralizationm,inimal Hemorrhage,local areas, mwerate -Not examined,not in plane of section -Adenosa -Not examined,missing The followingtissueswere foundto be withinnormal limits: Spleen,Heart, Uterus, Ovary, RamiaryBlind, Stomach,Thyroid,Trachea,Esophagus, SalivaryGland, Pancreas. ------------------------------------------------------------------------------------ Species: Rat Project Number: 0281CM12 Summarized STAR Page: 196 360 SummarizedSingleTabulatedihia&lReport (continued) IndividualMacroscopicand Microscopicobservations RikerLaboratoriesI,nc. V. FC-143:Two YearOralTositity-orcageliciS,tyudyin Rats Table:2 -------------------------- --------------------- ------------------------ ---------------- Animal Number: IR-4727 Sex: Female Grou;: 6) FC-14@j30 ppe Fate: (Ntekz10!) Tere@&naSlacrifice Macros,.op@IOcbservations: Sk Pituitary P.issirySia.-d H'Icrcsc",P@O4bc!ervat-,ons: Adrenal Kidney Lung Naaaa,y Gland Ovary Pancreas Pituitary U'6erus -Hairloss on head and neck. -Raiseddark mass,0.5 ce dia. -Mass,4 1 3 ce, rightaxillaryand threat areas;mass,7#ce dia.,leftside. -Sinusoidae!ctasia,-ortex,&irked -Pelviclineralizaticmni,nimal -Vascularsintrilizat'Lwoinl,d Hm rrhage,diffuse,marked -F;&broadencea -Cyst -Acinaratrophy,minimal -Adencia -Cysticglinds,marked The 4olj',omitni;ssueswere foundto be withinn",-tallimits: Sp!een,Liver,HEirt,Strsich,U,inaryBlaidderT,hyroid,ParattyroidT,rachea,Esophagus, Salivaryiland,Eye. -------------------------------------------- ------------------------------------ A-i44siN'u,tber:IR-4728 Sex:Fnile Group:f 6) FC-14330 ppe :ate:(Week= 84) Sir.riii.icnedextresis Hicrosco;icObservations: Abdomer(,internal) MicroscopicObservations: Adrenal. Kidney Liver Lung Resentery Pancreas Pituitary sp1w -- - -------- -Abdominalcavityfilledwithb!ocdyfluid; sest,itarayn,,o'stntusextens;.vely involvedwith nodular,grinl-latrissue, possiblytuneror chronicinflammation. -Sinuscidaelctasia,cortex,mild CcrI.icad!egeneration, mild metastaticneoplasm -Chronicprogressivneephropithya,ild Pelvicsintralizatiowni,ld metastaticneoplasm -Hipatccytveievolationo,ultifocal,minimal& Notatopoitsise,xtraeedullarym,inimal -Vasculasrintrilizatiowni,ld Aesotheliama.m.alignant -Metastaticneoplasm -Adenota -metastaticneoplasm Species:Rit hoject IWMer: 0281CROO12 Sunarized STO. Page: 197 361 Summarized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand Microscopicobservations RikerLIboratiDrieIsn,c. 3" FC-143: Two YearOral Yoxicity-oncogenicitSytudy in Rats ---------------- Table:2 - ------------- - --- ------------------------- Animal Number:IR-4728 Sex:Female Brou;: 6) FC-14330 ppe Fate: (Neek--94) Sacrificedin extroo4as N-a*croscapOib,s.ervations(continued): stomach UrinarySlaadder Llte@us -Urcer Metastaticneoplasm -Metastaticneoplasm -Cysticglands,sild T@.efcllow4.it;issueswerefoundto be withinnormallimits: Heart,Ovary,MammaryBli-I.T,hyroid,ParathyroidT,rachea,EsophagusS,alivaryalinj. -------------------------------- - --- --------------------------------- Animal Number: IR-477.9 Sex: Female Group: 1 6) FC-14'w30 pps Falle:(Week-1-05) TerminalS&acrifice racr-3s:opiotl.servations: Pitui4kiry Mammary Slin-ml K@scres,-.-pic Adrena'A K444.r.ey Liver Lung Himeary ilsand Piral%hyraid Pituitary -Smallraiseddarkmass,I co dia. -Lltilabulalrass,3.5x 3 ci,in rig@'t axills;largeoultilobulamrass, 9 x 6 x 3 ce,in thraitarea. -Sinusaidae!ctasia,cortex,moderate Corticaldegenerationl,ocalareas,moderate -Pelvicmineralizationm,inimal -Portalsononucleacrellinfiltrate, Nepatacytovacuclationo,ultifacilm,inimal -Vascularmineralizationa,4&ld Pneumoniai,nterstitialc,hr3nic,loci'a&reas, mild Hemorrhage,sul'6.iiocamli,niail Branulogao,ultifocala,ild -Fibroadoncea Fibraidenosa -Notexamined,not in plantof section -Adencoa The followingtissues*ere foundto be withinnormallimits: Spleen,Heart,Uterus,Ovary,Stomach,Urinarybladder,Thyroid,Trachei,Esophagus, Sal,A*viB-lyind,Pancreas. ------------------------ -------------- -- ------------- ------------------------------ Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 198 3 6 2 SummarizedSingle TabulatedAnimal Report lconti-lued) IndividualMicroscopicand microscopicobservations Riker LaboratoriesI,nc. 3m FC-143: Too Year Oral Toxicity-OncogeniciaSttyudy in Rats Table: 2 ---------------------------------- ---------------------------------------------------- Ar.@isaNlun-ber:IR-4730 Six: Feeale 6roup: 61 FC-143 30 ppe Fate; (Neekz 74) Found Dead micros,.opiOcbservations: massiry Bland A,,@'re7.&! r.itrostopiOcbservations: Adrenal Kidney Liver Iung Mismary Slanlu P;Atuitary Spleen -4iltilabularulceratedsubcutaneousmass, 4 1 3 x 2.! to, right&%ill&:cystic mammarygland,1.2 ce dia.,filleduilthsilky whitefluid,in leftin;uinal ire&. -Right adrenilenlarged. -Sinusaidalectasia,cortex,earked Corticaldegeneration,local areas, moderate -Chronicprogressivenophropithy,s;ald Kintral.izatiionnt,ersititiaclo.rtical, moderate -Portalsonoiucleacrellinfiltratet,ild Necrosis,sultifecala,iltd -Vascularminerilizi,icne,irital -Aderocarcincia silictocelf -Adencei -Nesitopoitsise,xtramedullaryi,ncreased, mild -poly; T6.e fcl!okin; 'Lissuewsere foundto be withinnormallimits: Heir'6., 0.,a-vS,losi,-hU,rinaryBladder,Thyroid,ParathyraidT,rachitiE,scohligus, Sa74ivary6'sand,Pancreas. -------------------------------- - -- -- --- ------------------- A@,.ilaNiuir.1-erI:P-4,"Jl Sex: Femalt 6roup: 6) FC-143 30 pps FitE: (Neekz 09) Sacrif4.,ei-nuelxtresis Macrt)s:o,,4cDbz-erva'6,-*.ons: Mammary 61and Liver Small Intestine MicroscopicObservations: Adrenal Kidney Liver Lung -Circularmass,3 ce dia.,in righta%i!la. -Paloand slightlyenlarged. -Area of ulcerationwith adhesions. -Corticalvacualation,diffuse,soderal%e Monsiderosis,diffuse,ci)rticile,i.ld 4retain resorptiondroplets,marked -Repatocytevacuolition,diffuse,marked Malignantlyaphoma,histiocytic -Malignantlyaphosa,histiocytic Attlectasisl,ocalareas,sild Species:Ril, Project Number: 0281CROOI&2 Summarized STAR Page: 199 363 Suuarized SingleTabulatedAnimalReport (CO"tiflutd) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-143:Tvo Year Oral Toxicity-OncoloniciSttyudyin Rats Table:2 --------------------------------------------- ---- ------------------------------ Animal Number:IR-4731 Sex:Fosale Broup: 6) FC-14330 ppe F&tE: (Week= 99) Sacrificedin extresis M4.cri)scopO4t,scervatiorsicon"64&nued.': Lys;kl Made mimmary Elar@,,, Nesentery Ovary Far.creas Salivaryslanj C.Ba'AIlnLtestine Spleen Stomach Urinary51adder -malignantlymphola,hist4locytic -FibroadLnosa -Hil@lg4&rant lyso'ass, histiocytic -malignantlyaphosa,histiocy'6,ic -Acinaratrophy,marked Malignantlymphosa,histiocytic -Not examined,missing -Ulcer,marked -Malignantlyaphota,hisltiocytic -Ulcer,oultiforala,-ald -Malignantlysphosi,h@s+.;kacytic The followingtissueswerefoundt: be withinnvo, il.limits: Uterus,Thyroid,ParathyroidT,rachea,'_scptagus Pita-taryH,eart. ------------------------------------------------------------------------------- Anima'aN@iaber:10-4"@"- Sex: Fesa'4eEreu;: 6) FC-14330 ppe Fate:(Week=q9)gicrifictidn extresis Hic."scapicObservi'Licris: Fituitiry HassiryBland Adre-ial& Liver MicroscopicObservations: Adrenal Kidney Liver Lung -- ------------------------------------- -RaisedBass,0.5 ce dia. -Cysticmass,4 ce dia.,possiblyinflimsed &ilkcyst,leftinguinaalrea; firecysticmiss,4 ce diii.p,ossiblytumor, in rightinguinalire&; largemiss,1411 10 x '.c'e, leftand right alilla. -Rightadrenalenlarged;leftadrenalpale *&is,0.7 ca dia. -Appearsswollenand enlarged. -Sinusoidaelctisia,cortex,marked Corticaldegenerationm,oderate Carcinomac,ortical,unilateral -Pelvicsineralizationm,arked V*phrasis,tubular,marked -.ystoiddegenerationf,ocal,sild Resitopoitsise,xtramedullarym,ild Necrosis,4ocal,minimal -Vascularlineralizitiomni,nimal Alveolareacrophages,mild Metastaticneoplasm Species:Rat Project Number: 0201CROO12 Sumear@zed STAR Page: 200 364 SummarizedSingle TabulatedAnimal Report (continued) IndividualN&CrcscOPicand hicrosropicObservations RikerLaboratoriesI,nc. 3H FC-1410:Two Year Oral Toxicity-oncogenicitSytudy in Rats ------------------- - --- ---------- ---- ------ ----------------------------- Table: Animal Number: IR-4732 So%: Fesile 6roup: 6) FC-147430 ppi Fate:(Wesix 99) Sacrificedin extrati5 N;Acrosca;iOcbservations(continued): Miamary S:and Pituitary Sp!eeri -Ffbroadencaa Fibroadenooi -Adencei -Netatopciesise,xtratedual6aryi,ncreased, mild The fcllowin;luissuewsere foundto be withinnormallimits: Heart, Uttrus,Ovary, Stomach,UrinaryBladder, Thyroid,Parithyraid,Trachea,Esophagus, sal;ivc.y6'*ard,Pancreas. ------------------------------------------------------------------------------------------ Animal MLaber: IF-4737, Sex: Female 6roup: 1 6) FC-141.310 ppe Fate: (Week=105)TerminalSacrifice Racrosco@-icObservatiolis: Observations: Adrenal K@adney Liver Lung Pitu-tary -No visiblelesions. -Sinusaidalactasia,cortex, moderate -Pelvicmintralizatim,mild -Nepatocytovacuolition,oultifocal,sild -Vascularsintralizationm,inimal Alveolar"crophages,oultifocal,milad -Adencei The fol&lcvi-tiigssueswere found to be withinnormal limits: Splee,-H.e,art,Uterus,Ovary,HistiryGland,Stomach,UrinaryBladder,Thyroid,Parithyrc;id, Trachea, Esophagus,Salivary 61&nd, Pancreas. ---------------------- - ---- - ---- ----- ------------------------------------------ AiiisaLleler: IR-4734 Sex: Female 6rojp: 6) FC-143 30 pps Fate: lneekz 95) Sacrificedin extreo;as RacrosccpicObservations: Pituitary Rameary 61and Liver NicroscapicObservations: Adrenal Liver Long Mammary Gland Pituitary ---- -- - -- ------ --- --- -- -Hescrrhagicoultilobularmass, 1.14x 0.0 ;a. -ry!il,miacss, 3 x 3 1 1.5 ce, in leftinguinal -Possiblyslightlypile. -Sinusaidalectis'aac,o,tex,moderate -Hapatocytevacnalition,peripartal,moderate -Hemorrhage,oultifocal,sild -Lobularhyperplatia,cystic -Adana@& - -- -- - Species: Rat Project Number: 0281CROO12 Sunarized STAR Page: 201 365 SummarizedSingle TabulatedAnimal Rtpcrt (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3P. FC-143:Two Year OralToxicity-oncoginicitSytudy in Rats Table:2 -------------------------- ------------------------------------ -------------------------- Animal Number:IR-4734 So%: Feeale Group:( 6) FC-14330 Fps Fate:(Neeka95) Sacrificeidn extremis MicroscopiOcbservations(continued): Sploe..i Stomach -Hecosiderosis,marked -Ulcer,oultifocals,ild The "'4,SSLwteSre foundto be withinnormallimits: Kidr,e-Hye,art,L"6,eruOsv,ary,UrinaryBladder,Thyroid,Parathyroid,Trachea,Esc;hagus, Sili-.arSylind,Pancreas. - --------------------------------------------------------------------------------------------- Animal Nuaber: IF,-471.5 Sex: Feaa!.eGroup: 6) FE-14'3v0 pps Fite:(keekz50)Sacrificeidn extremi.s MacroscopicOtse-vations: flaotariylind L44ver M44crosco;-'O4bcservations: A:rtnil Liver Lar,g Parathyraid Skin Spite-, -Large4irtmass,9 x 6.5 x 4.5 cm, ulceate4u skinsurface,rig.Ntaxills; circulamrass,2.5ca dii.,leftaxilla. -Paloareason all lobes. -Corticavlacuolitionf,ocal,sild Sinusoidaelctisia,cortex,aild -Necrosis,centrilobularm,arked -Vasculasrintralizatim,.sinisal -Notexamined,not in plantof section 4ibreas Fib-asirecoa -Hosatopoicsise,xtrasedullaryi,ncreased, mild The foilDwi.@t.igssuesPertfoundto be withinnormallimits: Kid.-teHye,art,UllerusO,vary, Stomach,UrinaryBladder,Thyroid,Trachea,Esophagus, Salivary61;rl.,Pitu-&taryP,ancreas,MammaryBland. ----------------------- --- --------------------- ------------ -------------------------An'iaa'Ntumber:IR-4736 Sex:Fisale Broup: 6) FC-14330 pps Fate: (Week=105)TerminalSacrifice MicroscopicObservations: -me visiblelesions. MicroscopiOcbwvations: Liver -Mpatocytealterationv,acuolatedf,ocal, minimal Parithyraid -W examined,missing Pituitary -Adenosa Thyroid -Not examined,missing -- ---- --- -------- -------------------------------------- ------------------- Specin: Rat Project Number: 0291CROO12 Sum rized STAR Page: 202 366 SummarizedSingle TabulatedAnimal Reprrt (cont4anced) IndividualNacroscapicand Hicrosta;icObservations RikerLaboratoriesI,nc. 3h FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 ------------------------- ---- --- --- -- -------------------------------------- An@iii!Number: IR-4736 Sex: Femile 6roup: ( 6) FC-141@30 ppi Fite: (Weekz105)TerminalSacrifice RicroscapicObservations(continued): The followingtissueswere 4oundto be mithirnormalligits: Spleen,Kidney, Heart, Lun;, Uterus, Ovary, Mammary Slind, Stomach,Urinary Bladder,A4wrenal, Trir@se--. Sa!ivarySland, Pancreas. --------------------------------------------------------------------------------------------- Ar.ita!Number: IR-4737 Sex: Feealle Broup: 6) FC-14.13p0 pps Fi'6e:(Wee@.z105) TerminalSacrifice Na,-ros@,opiOcbservations: Pituitary N&Bgary Gland micros:op;i'cUtservit;&..-s: Adrenal K-.Iwney -RI;Ase,R6igs, 0.6 cc -?iiiss2, x !.'ac!.,44.p"e"@nz.l-i*?.,ii,c;a5s., 4 ectas;.&c.ortex,to.@e'al! -U'hr:n@ipcra;ressivene;h,,z;atlyilL;lr,4i;l -..er S'and -Vasc-.Iir -F; -Tutu'@irhyperp@.isa*ib,ilite-FL!,Bode?.;4ue chrcni,-a,-l'il 6issits were be n,6piial Ur;a-@ary -------------------------------------------------------------------------------------------- !F,-17."E Sex: Feti'IE6ro@.;:f 6) F:-14@'3,C p:s e-,tret;s ,4&:rcscapiOtbservalliors: mammary 31&!-.., -'LarQesut:ul,a"eauasiss, 9 x 12 x 5 ct, 4in Adrenal -Lei'at-enalS14g@41y enl&rqed. Hicrosco;4&c 0,6serval%,ions: Adrenal -Porticilivacualit-4.o-.i,local areas, moderate Sinuscidal ecliasia,cortex, moderate Nodular hyperplasia, corilex,fatal, moderate Kidney -Pelvic mineralization,sild ------------------------------------------------------------------ --------------- Species: Rit Preject Number: 0201CROOI.1 Summarized STU Page: 203 367 SummarizedSirgleTabulatedAnizalRepvt (cofitinued) Indv'&djaMlicroscopicInd Microscopicobservations RikerLaboratories,Inc, 3H F'6-1474T:oe Year Or&'&Toxicity-CncoglnicitSytudy in Rats Table: -------------------------------------------------------------------------------------------- Anisal Number: IR-4738 Sex: Foolle Group: 6) FC-141.30 ppe F,itt:(Week-1-01) Sacrificedin extresis micrt)s-,Dpa@tas,e,rvations(continuil): Liver Lung Mineary 6'4iid F'ii,-uitary Slin Sltoai:h Tt.yrai.1 -Repatocytealteration,basopt.-ili4c0,cal, mild -Vascularsintralizations,ild -Not exleiied.missing -No diagnosis,inadequatesection 4ibromi -Necrosis,focal, aucosal&,@@Ild -Hyperplasia,C cell,focal,s4.1d The fell'aawitnigssueswere found to be within normallimits: Spleen,Heart, Uterus,Ovary, Urinary?ladder,Paral@hyraidT,rachea,Esophagus,SalivaryBland, ---------------------------------------- ---------------------- ---------------------Animil K-ut4.er:!R-4-11-4?9 Sex: Facile Group: 61 FC-143 "loppe Fa4@e:(keeit IAE ) TtrainalS.acri4ice -3bse,va',u4.ors: r,.aikli6r1y'a-d c.pleer. MicroszcpicObservations: Ad-er.al Feart Kidr.ey Liver Lung Mammary 61,and Skin Spleen -Yerylargeoultilabularmass, 14.5x 10 6..r ca, in the axillaryand lateral area. -Enlarged -Sinuscidiilctasia,cortex,mcderiltt Keaato;oitsisi,xtrasidullaryc,ortical, moderate -Hyacarditis,chronicnonsuppurative, oulti4o:als,ild -Proteinresorptiondroplets,tubular,tild Pigmt, conv.tub.epitheliumm,aderiit kephrosis,tubular,aild -Nesatopciesise,xtrasidullarym,il&d -Yascularaineralizations,i.ld Hyperplasiau,ptal cell,focal,gild -No,,examine-MIm,issing -Fib?,osarccei Extensivenecrosis and ulcerat'Aar@N.-. misla-ytissueir tugor. -Reei'Lopoits4Aesx,traoidullary,increased, marked The follovin;tissuesare found to be withinncrei'l4imits: Uterus,Ovary,Stemach,UrinaryBladder,Thyroid,Parithyroid,Trrhei, Esvobagus, ---------------------- -- - - ---------------- - - ---------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 204 368 Suuari:edgirigiTtabulatedAniul Report(continued) IndividualMicroscopicand MicroscopicObsrvit44ons RikerLaboratoriesI,nc. 3H FC-1410T:oo Year Oral Toxicity-OntogefticSittuydyin Rats Talule:2 --------- ----------------------------&- - - --------- --- ----------------- ---------A,,italNumber: IR-4,139 Sex: Female Group: ( 6) FC-147V30 ppe Fate: (Week=105)TerminalSacrifice K@kcroscapiOcbservations(continued)*. The fol'.os;'t4ins;sues were 43undto be withinnorsa1ilimits(continued): SalivaryGland, Pitu4.1.arPya,ntreas.' -----------------------------------7----------------- - --------- ------------------- ---------- Number: !R-4740 Sex:Fetile greu;: 6) FC-,47W30 ppe File: iWEeLz 1051,Tersipal Sacr@@;i:e VacroscepicObservations: Mammary iland Cbservations: Adrena: Kidney Liver Lung Matisa?,yGland FirathyrDid P4Atuitary Thyr.o4d -Hass,4 x 3 1 1 ca. in perinealire&. -Sinusoidalectasia,cortex,moderate Medullarycell hyperplasia,sulltifocale,;Ald -Pelvicsintralizatiorm.i,ld -Hepatocytealteration,vicuelatel,sild Hepitacytealteration,basDphil4&cs,ild -Yascula.,sintral-azatione,il,.J, Perivascularsonanuclearinfilalurevo,441d -Labularhyper;lasia -N2t txaeined,not in planeof section -Aderoma -Ulticabrinchiaclyst The ;ollow'Lrt,i;ssueswere foundto be *;ithinortallie-6ts: S;Ieen,Hear",Uterus, Ovary,Stomach,UrinaryBladder,Trachea,Esophagus,SalivaryBland, Fanc-eis. - -------------------------------- - ------------------------- A,-i'442u;m!ber:'R-4741& Sex: Femilt Grou;:t 6) FC-14330 ppe Fa*.e:(Weeka 97)Sacrificedin ektresis F-acrosco;4cObservat44ofts: Pi ,u;.tary Kaseary Gland MicroscopicObservations: Adrenal Kidney Lung Mammary 61&and Parathyraid Pituitary -Raiseddark mass, 1.3 to dia. -Nodularlesion,I cm dia.,in perinealarea. -Sinusaidalottas-'&ac,ortex,moderate -@Chronicprogressiventphropathy,mild -Yas:ularsingrali:ationm,inimal Hm rrhage,focal,mild -Lobularhyperplasia -Not examined,not in plane of section -Admosa The followingtissueswire foundto be withinnormallimits: Spleen,Liver,Heart, Uterus,Ovary, Stomach,UrinaryBladder,Thyroid,Tracbta,Esophagus, --- ---------- Species: Rat Project Number: 0281CH012 SMir@a2ed STAR Page: 205 369 SummarizedSingleTabulatedAnimalReport (continued) Individualhcroscopic and Picroscopic Observations RikerLaboratoriesI,n!-.3N FC-147.T:wo Year Oral Toxicity-OncogeniciSttyudy ir Rats Table:2 ------------------- ----------------------------------------------------- - Animal Number:IR-4741 Sex:Fegall Group:t 6) FC-1437VOppe Fate:(Weeks 97) Sacrificeidn extresis hicrosco;i,C-".si,va'k.'(6caopnstinLed): The 'LissLewserefoundtc be Nittinnor@&'l,imits(continued): S-a-l-i-va-r-y-S-la-n-4-a-,Pa-n-c-r-ea-s-,--------------------------------------------------------------------------- Ariisi"Nuater:IF.-47414 Sex: Female Sroup: 6) F".-IC@30 pps Fate: (kee4!.6=3) FoundDead Racros:o;ic06,,serval.ions: Kastary Bl.and Adrenil P41tuitiry ricros:r;iOcbservations: Adrenal Esuphi;-,s Kidney Liver Lung mammary Blind Pancreas Parathyraid Pituitar) Spleen Tt-,Yrc-*.d Trachei -Largesultilaobul@iarss,10 x 9 x ivce, in rightixilla;necrotimciss, 4 x 3 ct, inleftinqu-"nairlea. -Possiblyslightlyenlarged. -Hemorrhagicmass,0.5 ce dia. -ginuscidaelctasia,cortt-.m,oderate -Mt extained,missing -Pelvicsineralizatiosni,ld -WKrosis,oultifocals,ild Atrophy,hopitocytesc,ontrilobulirm,oderate -Vascularsineralizatiosni,ld -fibroadenome Fibroadenm -Nct examined,missing -Not examined,missing -Adencea -Not examined,missing -Not examined,lissin; -Not exigine,Wm,issing The followingtissuesmitre4ct,.rt@zdbe withinncreallisits: Hear+,Uterus,Ovary,Stomach,Ur4.narByladder,Sal4vay Gland. ------------------------------------------------------------------------------------ Ar,@asakluslwer:IR-474"p Sex:Fesile Group: 6) FC-14330 pps Fate:(Weekz 97) Sacrificeidn extromis Hicrusco;itObservations: Pituitary RactaryBlind Lung Liver -- ---- -------------------------- --- - -Raisedhemorrhagicmass, I ce dia. -Circularmass,2 ce dia,in perintalarea. -Areasof consolidatioin ri,htinterioarnd apicallobes. -Possiblymottled ----------------------- Species:Ral Project Number: 02elCROO12 Susevized STAR Page: 206 370 SumairizedSingleTabulatedAnimalRepar64 (co9t"ftu2d) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3" FC-143:Two YearOr&! Toxicity-oncog,nicitSytudy in Rats -------------------------------------------- Table: -------------------------------------- Ani.salMi.-oberI:R-4743 Sex:Female Broup: 6) FC-14'4310 ppe Fate: (Week.=97)-Sacrificeidn gitregias MicroscopicObservations(continued): Ad-er.-a'. Kidney Liver LL-n; HattiryGland Pin@@reas Urinary Bladder UtErLS -slnus34Adaelctasia,cortex.mild -Pelvicaineriliz&16-ioara.r,kge -RePitacYtevi:uclat4on,peripcrtil,moderate Repitocytealteration,basophilic,focal, mild -Vascularr.;Aneralizatitoinl,.4 Pneumonia,acute exudative,local areas, oil4u Hemorrhage,ELItifocal,ail&d -Fibreadenosi -Acinaratrophy,sild -Adenosa -Epithelialhyperplasias,imple,diffuse,mild -Cysticglands,marked T"-;ieolalowintgissueswere found to be within normal&limits: Spleen,Heart, Ovary,StomaO, Thyroid,Parathyraid,Trachea,Eso7bagus,SalivaryBland,Skin. --------------------------------------------- -------------- -- --------------------------- A.-;IsNii'jsaleIrR:-4744 Sex: Fatale Group: 6) FC-14330 pps Fille:@"Weeks 48) Four,,D.e';d macroscap4acObservations: mangary 6'and Heart Lung 4icrcscopiaOcbservations: Kidney Lung Mammary BlinO. pi,6,u;.tary Spleen ---------------------------------- -Piss,8.5 x 7.! 1 4.5 ce, hal.1,3.vav4,i.-y filledwithbrownmatter,in left ir.guinaalrea. -Possiblyslightlyenlarged. -Multiplegrayish tar,ra4ase.i1ctu,ei,0.1- 0.3 ce dia.;2 nodulesin leftlobe; 3 nodulesin rightcardiaclobe;2 nodulesin ril.kt intermediatelobe; 3 nod@;lesin right diaphragmaticlobe. -Chronicprogressiverep,6iropithmyi,nimal -metastaticr@ecolast Hemorrhage,local areas,mild -Adenotarcinama Extensivene,.rosiisn tutor;areashighly aniplasticL.ocallyinvasive.Multipleluni se,6&stases. -No diagnosis,inadequatesection -Hematcpoiesise,ztratedullary,increased, moderate - ---------- ----------- --- ----------- Species: Ra,L Project Number: 0291CROOIA2 371 Smarized STAR Pico: 2'V'7 gumirizld SingleTabulatedAnimalReport (cofitinued) lndividua*glacrcscOOitInd MicroscopicObservitiops RikerLaboratoriesi,nc. 3M FC-14'.T'w:o Year Oral Toxicity-ohco;en44cSittuydyin Rits Table: 2 -------------------------------------------------------------------------------------------- Animal Number: IR-4744 Sex: Feaalse SROUP: ( 6) FC-143 30 ppit Fi'6e:fweckz 49) Found Dead Microico;ic (con,6;nued): The t-.ssueswere found to be withinnormal&limits: Liver, Hei"", U46-erusnw,viry,StositilUlr.i.naryBladder,Adrenal,Thyroid,Parathyroid,Trachea, "sop'-laguSsa.l,;lvaryS'ird, Pan-reas. -------------------------------------- --- - --------------- ------------------------------- Ar.ima'ANumber-: IF-47414 Sex: Female Brou;: 6) FC-14'v30 Fat-e:(Week=10r@.T)erminal Sacrifice Macroscopic Observa'6ions: Pituitary hampiry Slan6,lA R-icroscap4A@O-bservations: Adrenal Esop'la;us Kidney F,asci-yBlind Oviry Piluu4'Lary -Stillri-Aseddark mass,0.4 ce dia. -Kass,5 x 4 x 2 ce, in perinealakrea. -Sinusaidalectisia,cvtox, moderate -Not examined,aissi,-ig -Chronic progressivenephropal%.tys,ilad Pelvi,m-ineralizationm,ild -Vas.-ulamrineralizations,ild Pneumonia,interstitialc,hronic,oultifocal, ii!d Alveolarwrophages, oulti4ocal,s-.1d -Fibroadennea -Tubularhyperp',asiaU,nilateral,moderate Granulosacell tumor,benign,un,.1iteral -Ade-.ict..a The fo'alowint;issueswere foun,.t'o be within normallit4its: Spleen,L-aver,Heirt,Uterus,Stomach,UrinaryBladder,Thyroid,Parithyraid,Trichea, Sal-',varEvlan.,,Pan:reas. ---------------------------------------------------------------------------------------------Animal Ki;aber:IR-4746 Sex: Femile Broup: 6) FC-143 30 pps Fate: (Weekz 87) Sacrificedin extreais MicroscopicObservations: Pituitary Hismary Slaard -Enlargedwith0.7 ce dia.&ass. -Rultilobalamiarss, 11 x 6 x 3 .a, in left i..kguinalre;. SPIM MicroscopicMsLrvitions: -S'4ight'Aeynlar;ed Ad-er.al Kidney -Sinusoidaelctisia,cvtox, mild -Pelvicmineralizationm,inimal Liver -HIPa'60CYtYe&CUOlat4alMB,UIti#Kgl, minimal Hipatacytealteration,basophilic,oultifdcal&, mild Kesa'6opoitsietx,tramedullarys,ultifocal, minimal -------------------------------------- -------------------- ---- --------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 208 372 SummarizeSdingleTabulateAdnimalReport(Coll"ifluld) IndividualMacroscopicand MicroscopicObservations Rike,Laboratvits,Inc. 3N FC-143:Too Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 ---------------------------------------- ---------- ---- ---------------------------- Animal Number: IR-4746 Sex:Female Group: ( 6) FC-14'v30 pps Fate:(4eeka97) Sacrificedin extresis MicroscopicObservations(continued): Lur.,g Mammary Blind Pituitary Spleen -vascLIarsintralititiosni,ld -Adenc:artincea -Ad-in= -Resitapoitsite,xtrasedullary,@.rcreased, moderate The 4allacN@Li; tissues were found to be within normal liai6..s: Heart, U4,erus,Ovary, Stomach,UrinaryBladder,Thyroid,Parathyraid,Trachea,Esophagus, Sal,'.VarEy'La-idP,ar.:rees. -------------------------------------------- Animal Number: IP-4,47 Sei: Female Group: L) FC-143 30 ppe Fite: (WeeksIO'liT'elraina:Sacrifice gicroscop;.c 01&-serva4liDns: Mammary Sland MicroscopicObservations: Adrenal ve!- 16uiig mauiry slan,u Ovary Pancreas Skin Spleen -Lobularmass,5 1 4 1 3 co, in thrcatarea; labularmass,5 1 2.6 x 1.5 ca, in leftaxilla;labularmass,7 x 4.! x 3 co, in rig@t ingu4Analarea. -Sinusw&dalectasia,cortex,sild Medullarycall hyperplasis,ou'Atifecala,;&,Id -Portalsonanucliicaerll infiltratem,ild Portalbileductproliferations,ild Regatopoitsit,extrasedul4larmyi,tisal Rep,il6acyatleterationb,asqtilic,oultifecil, sild -Yascularsi.neralizatiomni,nimal Alveolarmacrophages,sild 4ibroadenosa Fibroadenna -Cyst,unilateral -No,.examined, RiSS4.n; -Fitrcma -Heialuopo@&esiesx,trasemlullaryi,ncreased, oild The followingtissueswere 4ouidto be *;thinnormallimits: Kidney,Heart, Uttrus,Stomach,UrinaryBladder, Pa.,a+.hyraidT,rachea, Es2phagus, Sa'.ivarGyla-id,Pituitary. --------------------------------------------------- ----- ------------- Species: Rat Project Number: 0281CROO'42 Summarized STAR Page: 209 373 Sumlir;zgSdingleTabulatedAnimalReport(coritirued) individualMacroscopicand MicroscopicObservit,.ons RikerLaboratoriesI,nc. 3H FC-143:Tvo Year Oril Toxicity-OncogeniciSttyudyin Rats Table:2 ---------------------------------------------------------------------------- ---------- Animal Number: JR-4748 Sex:Fesile Group: 6) FC-14330 pps Fate: (Weekz01) Sacrificedin extromis MicroscopicObiervitions: Pi4,-j4,tary %&&miry Slind Adrenal kidney Microscopicobservations: Adrenal ESDph&QL:S K@dney Liver Lung Mammary Gland Piriithyroid P@&tuita?-y Thyroid Trachea U.-inaryBladder -Enlargtdue to red miss,1.31 1.2x 0.0 ca. -Subcutaneoumsass,3.5 x 3.q ce, left axillary;subcutaneougsals, 1.51 2 CA,leftinguinil. -Rightadrenaldarkenedandenlarged,1.4 ca dia.,f-&1'4weidti@reddishliquid. -Sealslcyst, 0.4 ca dia., or,suria--eof le4l, kidney. -Sinusaidailtctasiac,ortex,marked Corticaldegentratioim,oderate -Not examined,missing -Chronicprogressivenophropithy,s@Ald -Portalmononucleacrallinfiltrites,ild Hipatocytaelterationb,asapbilico,ultifeca's, mild -Yasculirmineralizationm,ild Neevrhige,localareas,mild -Fibroadenota Adinocarcinosa Balattectle -Notexisined,sissin; -Adenosa -Not examined,sissin; -Not examined,missing -Ep-Athel-4hiylperplas@bas,iaple,local areas, mild The fellaNi:@.tgissues more found 16abe Nithin normal limits: S;IeeriFlear'%U,tLrus,Ovary,Stomach,SalivaryBlind,Pancreas. ------- ------------------- -------- AnisalNumber: IR-4749 Six: Female Broup: 6) FC-14330 ppe Fate: (Weekz 0',1S6a)crificedin extresis Macroscopic Pituitary Mammary Blind -Hemorrhagicmass, I i O..gc,e@dia. -Smallmilkcystpresent. MicroscopicObservations: Adrenal -Sinusoidaelctisia,cortex,marked Kidney -Chronicprogressivnetphropathys,ild Pelvicmineralizationm,ild - --- ---------------------- --------------- --- ------ Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 210 374 SummarizseidnglTeabulatAendimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesl,ot. 3h .FC-143:Two Year Oral 70ticity-oncogenicitSytudy in Rats -------------- --------- ---- ------- ----- -------------- --- ---------A-iisalNumber: IR-4749 Six: Female Sroup:( 6) FC-14330 pps Fate: (Weekz 82) Sacrificedin extresis Table: 2 ------------- MicroscopicObservations(continued): Lu,n; Mammary giand Pituif.a-y -Vascularsintralizitionm,ild Hemorrhage,local areas, mi'Ad -Balacto,-ele -Adencea' The follow@Aftli.s;sueswere found tc be withinnormallia;.ts: SplatenL,iver,Heart,Uterus,Ovary,Stomach,UrinaryBladder,Thyroid,FIrathyraid,Trichea. Esc,.hi;us,Sal4ivarGyland, Pancreas,Eye, Skin. ----------------------------------------------------------------------------------------- Animal Nuaber: IR-4750 Sex: Feea.e Broup: 6) FC-14330 ppe Fite: (Week= 97) Found Dead Macrosc3picObservations: P.anary Gland Pituitary Hicres:opicObservations: Adrenal HarderianBlind Kid-,ley @.iver Lung Mammary Bland Parathyro@4d P'ituitary Thyroid Uterus -NLItilabulamriss,0.3 1 2 to, in righl, irguir.,atrle&;oulatilebulimlirss, 9.5 1 5 x 4 ca, in rightaxilla. -Enlargid,0.9 cm dia. -Sinusaidalectasii,cortex,mild -Adenotartincla Not describedat necrapsy. Probablyfrom clinicallydescribedatrophicright eye. -Pelvicsintralizations,ild -Hipatocytevacuclations,ultifocal,mild -Edema,localareas, aild -Fibroadenou B&IiCtKIlt Fibroadenna -Not examined,missing -Adenona -Not examined,missing -Cysticglands,marked The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Ovary,Stomach,UrinaryBladder,Triciti,Esophagus,SalivaryBlind,Pan-.rets. SpeciiiiR:at Project Number: 0291CROO12 SuseariziidSTAR Page: 21! 375 SussariztSdingleTabulateAdnimalReport(.continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3m FC-143:Two Year Oral Toxicity-DncogenicitSytudy in Rats Table: 2 ---- ----------------------- --- ------------------ ------- --- --- --------------- ------ Animaliugblr: IF-4751 Sex: Female Group: 6) FC-14'@@30 pps Fate: (Week= 4&) Found Dead Microscapi:Observations: Mammary Gland M4icrosc,.piOcbservat4aans: Kidney Lur,g Skin Spleen Stomach -Subcutaneousmass, 6 1 5.5 1 4.5 ca., right alilli -Pelvicsinerilizatiorm,i,nimal, -Yascularminera'4izitiomni,nissil -Fibroma -Nesi'Lopciesiesx,trasedullaryi,ncreased, sederate -U'@cer The followingtissueswere foundto be withinnormallimits: Liver,heart,Uterus,Ovary,HissaryGland,UriraryBladder,Adrenal,Thyroid,Parithyraid, Trachea,Esophagus,SalivaryGland,Pituitary,Pancreas. ------------------------------------------- -- ----------- ---- ----------------------- Animal Number: IR-4752 Six: Fetile Of-cup: 6) FC-143 30 ppe Fate: (Week=1051 Ter&44rtaSlacrifice MacroscopicObservations: P-a'tuitary Observations: A-WI."enal Kid.".ey Lung Ovary Pai-,,.reas P;'6ui'Lary -Raisedhemorrhagicmass, 0.4 co dia. -Sinusaidalectasia,cortex,moderate Nodularhyperplasia,cortex,moderate -Chronicprogressivenephropatly,z4'Ad Pelvic Mineralization,24&nisa! -Viks,,ulsairieralizationm,i'&d -Cyst,bilateral Tubularhyperplasia,bilateral,moderate -Hype.,plasiias,let-.ell,mild -Adenomi The followingtissueswere fourdto be *;.thinnormallimits: Spl&een,Liver,Heart,Ullerus,Manary Sland,Stomach,UrinaryBladder,Thyroid,Parithyroid, Trachea,Esophagus,SalivaryBlind. ----------------- - ---- ---- --- -- -------------------------------- AriisalNumber: I&R-4753 Ses: Female Sroup: 1 6) FC-14.'3F0 ppe Fate: (Neeks105)TerminalSacrifice RacruseapicObservatiofts: Pituitary Skin Mammary Sland -EnlargedNith smalldark lesions,0.2 ca dia. -Nair less on head. -Labular@ass,4 1 3 x 2 ce, in perinea!area. Species: Rat Project Number: 0281CROO12 Summarized STU Page: 212 376 SusiarizSeidngleTabulateAenimalReport(COft46iftued) IndividuMaclroscopaibcdMicroscopOibcservations RikerLaboratcriesI,nc. 3H FC-1.43:Two Year Oral Toxicity-UncogenicitSytudy 'anRats Table: ----------------------------------------------------------------------------------------- Anigil Number: IR-4753 Sex: Female 6roup: 6) FC-143 30 ppa Fite: tweekz105)TerainilSacrifice MicroscopicObservationstcontinued): Kid-iey Liver Lung Ma2siry Gland Ovary Pitui'6iry Splzeen -Sinusridaelctasia,cortex,sild -Pelvicmineralizal.iounn,ilateral,marked -Portal.sonenuclecaerll infiltrateo,,',Id Portalbile duct proliferationa,@Ild Hopitacytevicuolatio-o.uil,tifocal,sild Htpatacytealteration,v&clolated,mild -Vas,-ulimrintralizatiora.i,ld -Fibroadeiama -Tubularhyperplasia,bilateral,moderate -Adenosa -Not examined,missing The 4ollow4antgissueswere found to be withinnormal limits: Hear+., to-.rusS,tomach,Urinary Bl&dAuer,Tilraid,Pirathyro4d,Trachea..Esophagus, Salivary61,ind,Pancreas. --- --------------------------------------------------------------- -- ------------------ Anima'@Number: IR-47!4 Sex: Femile Broup: 6) FC-14330 ppe '&'6e:(Week=105) le-sinalSacrifice Ma:rcscapi:Observations: Mimiary Bland Mi,,roscap4lOcbservations: Ad,en,il Kidney Liver Lung Namiary 61&nd Ovary Pituil.ary Spleen -Lob'ulatemdass,0 x 6 s 3 ce, in inguiniland perinealareas;mass is quite .te".rataincd cystic. -Sinusaidalectasia,cortex,moderate -Figeent,conv.tub. epithelium,brown, moderate -Portalsononucltacrell infiltra'6sei,.ld Portilbile duct proliferatio@m-iil,d Nepatocytovicualaationo,ultifocal,mild Hipatacytoalteration,vicuclated,sild -Yasculirmineralizatidns,ild Pneumonia,interst4gtiaclh,ronic,oultifocal, sild Alveolarsacrophiges,oulti4ocal,a@ald -Adenocarcincei -Cyst,unilateral -Adencea -Hesal.opoitsiesx,tramedullary,in,.reased, moderate The followingtissueswere foundto be Nithinnormillimits: Heart, Uterus,Stomach,UrinaryBladder,Thyroid,Parithyraid,Trachea,Esophagus, ---- - --- ---------------- --- ------------- ---------------------------------- -- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 213 377 Sulair;zedSingleTabulatedAnimalReport (continued) lftdlvi;u&Mlacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FC-14'vT:wo Year Oral Toxicity-OncogenicitSytudy in Rats Table:2 --------- --- ---------------------------------- - - ------- -------- --- --- ----------- Ar,iza!Kimber:IR-4754 SeK: Female Group:( 6) FC-14330 ppe Fate:(Weeks105)TerminalSacrifice MicroscopiOcbservations(continued): The #Dllowiftt;issueswerefound-t6be withinnormallimits(continued,: SalivarySland,Pancreas. -------------------------------------------------------------------------------------- Animal Number: IR-474@5 Sex, Female Group: 6; FC-141@ '410 Fate: (Week=IOIJIT'ere4aniSlicrifice Hir.roscc;4&Ocbsery&4.-4.ors: Pitt:;Atary MicroscopicObservatiors: Adrfnil Esophagus Heart Kid.ney Liver Luft; Ovary Parathyroid Pituitary Thyroid Trachea -Hemorrhagic@ass,0.7 ce dii. -Siftusaidiatltasia,cortex,moderate -Not exaiiinedm,issing -Nyocarditisc,hronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropathy,sin4Aai! Pelyi,n-ifteraliza'6imoinl,d -Hopatacytaelterationb,isophilicf,oci'&, gild -Alveolarsacrophages,focal,minimal -Tubularhyperplasiab,ilateral&m,oderate -Not examined,missing -Adencea -Ncluexamined,missing -Not examined,I-Ass;&rg The 4ellovin;luissuewserefoundto be withinnormallisi,'6s: Spleen,Uterus,Hastary61&indS,tomach,UrinaryBladder,SalivaryGland,Pancreas,Skin. ------------------------------------------------------------------------------------------ Species:Rat Project Number: 0281CROO!2 Suswized STAR Page: 214 378 Tissue Inventory Tablt:3 RikerLdwitories, Inc. 3H FC-143:Two YearoralToxicity-OncogenicSittuydyin Rats- One YearInterim Project Number: 0261CROO12 Species: Rat Dose Sroup Nast: CONTROL 0 ppe Tissue Name Anisal Numbers Sex RRRRRPRRRARRRRRRRRRRRRRRR ------------------------3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 44 4 4 4 4 5555555555555555555556666 1 12 2 23 4 45 5 5 6 7 7 6 7 86 0 9 90 0 1 2 6 7 0 2 7 5 3 6 0 19 8 0 5 0 8 2 5 8 9 0 19 0 0 N N N N N N N NN N N A N N N F FF F F F F FF F Adrenal + 4 ...4 + + + 4...4........... Aorta Done Narrow Brain + + . . .. . . 4 4 + 4 + + . . .. . . . . . . . + *+ 4 . *+4+ 4+ 4c4 . 4 .. . .........# 4 ............ Esophagus Eye Heart + 4 + 4 .. . . . 4 + 4 + 4 + 4 + + 4 4 . . .. . ..... .......4 + 4 + 4 + + + + + *+ 4 + 4 +4. Kidney Large Intestine Liver .....4 + 4 + + . 4 + 4 ... + + + + . .. . . . . + . * C . ......4 ... . . . . . . . . . # + + + 4 + . . . . . . 4 + Lung Lymph Node (sesenteric) HissiryBlind Ovary Pancreas Pirathyraid + 4 + + + 4 + 4 + # ++ + + . ++ C + C + 4 4 + *+ 4 + 4 . c ..... c 4 + + 4 - 4 -- - - - - -- - - - 4 + 4 . . . . .. . - - - - - - - - - - - - - - - 4 + + + +.+ 4 + 4 + . . . . .4 + # + + 4 + 4 . . . . .. . C C C C + C .....C C 4 C C C C + C + 4 + C Pituitary Prostate SalivaryGland + 4 c + +4 + + + ++ . 4 + 4 . . . . .. . ...4 + .. 4 + 4 + + 4 ---------- ...4 + 4 + 4 + + + + + 4 4 + + + . 4. Small Intestine + + + + 4 + + 4 + + 4 4 + + + 4 .....* + + Spinal Cord Spleen Stomach Testis/Epididysis ...4 ...4 + 4 + 4 + 4 C 4 + + C + + 4... + 4 .......4 + 4 + 4 .....4 . . .4 + ...4 ...C + 4 4 + + 4 + 4 + 4 + 4 + + + 4 + . . . . 4 4 + + + 4 + + . .. . .. . . . . .. . Thyroid C C +C+C +4+ *+ ++ *. + +++ Trachea Urinary Bladder Uterus . .. . .. . 4 + # + + + 4 . . .4 + 44 + *+ ++++++. c .......c tiSSUI(S)- - - - - - - - - - - - - - - - - 4 . . . 4 + ------ -- Thefolloving we not requiredby protocol rountary Skin LWater - - - - -4 - - - - - - - -- - -- - - - - - - - ------------------------- - - - - - - - - - - - - - - - - -- - - - - - - - A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentwas made. A c indicattsonly a nandiagnosticcomment*as @ado. Pleaseri4er to the SingleTabulatedAnimalReport. Tissut InventoryPage: 215 379 Tissue Inventory(continued) Table: 3 RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Toxicity-OntagenicitSytudy in Rats - One Year Interim Project Number: 0281CROO12 Species: Rat Tissue Name Dose Group Name: CONTROL 0 ppm IIII RRRRR Anisal Numbers - - - - 44444 66666 23334 90 1 20 Sex F F F F F Adrenal +++4+ Aorta c4+++ Done Narrow Brain ...44 + 4... Esophagus ...4+ Eye + 4 ... Heart ... .. Kidney ...4 + Large Intestine .+ 4 . Liver Lung Lymph Node (sesenteric) Mammary Gland Ovary +.4 + 4 + +4+++ ++C ++ +++44 +4+4+ Pancreas ..... Parithyraid Pituitary Prostate ccc +c ...4 + ---- - Salivary Gland ..... Small Intestine + 4 ... Spinal Cord ..... Spleen Stomach. +4+++ 44+4+ Testis/Epididysis Thyroid 4- -c +- +- -+ Trachea + 4... UrinaryBladder +4c4+ Uterus +++4+ ---- - ------Nesentary Skin Ureter Thefollovintgissue(sw)ere not requiredby protocol ----- +-------- A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentNis Bade. A c indicatesonly a nomiagnostic commentwas made. Pleaserefer to the SingleTabulatedAnimalReport. Tissue InventoryPage: 216 380 TissueInventory(continued) RikerLaboratoriesI,nc. 3M FC-143:Two Year Oral 7oxicitY-DnccgenicitSytudy in Rats Table: One Year Interim Project Number:0201CROO12 species:Rat Dose Sroup Name: FC-143 300 ppa Tissue Nace Animal Numbers Sex RRRRR9RRRRRRRRRRRRRRRRRRR - - - - -- -- - - - - - -- - - - - - - - - - 3 3 3 3 3 3 3 3 3 3 3 3 3 3 '14 4 4 4 4 4 4 4 4 4 5 55 5 56 6 6 6 6 66 6 6 6 6 6 6 6 6 6 6 6 6 6 8 6 8 9 9 0 1 12 2 2 2 3 4 4 4 5 5 5 6 6 6 77 7 4 6 9 2 64 3 7 0 2 6 7 8 2 3 2 2 5 6 4 6 9 14 6 NNNNNNANNNNNNNNFFFFFFFFFF Adrenal + ++ 4 . 4+4 +4 . Aorta Done Narrow C + C + + C + + C ......4 + C ...4 + + + + .. . + 4 +4 + 4. 4 . ...... Brain ...++ + 4 .....4 .....4 * * + Esophagus + 4 + *. 4 + 4 . . . . .4 . 4 +C + Eye Heart * ......4 4 + 4 + + 4 + * + * . 4+4+ + 4 + 4 + + + 4 + 4 + 4 + 4 + +,+ + + 4 . . . . . Kidney 4 4 . . .. . . .4 + 4 . .. . . . . . . . . 4 + Large Intestine Liver ...4 + 4 .....4 + 4 + 4 ...4 . C+ +.+ + * + + . . . + + 4 . 4 + 4 . 4 + Lung .......* . 4 + 4 + 4 4 4...4. Lymph Made (mosenteric) ...* 4 4 ......C t+ 4 + + C 4 + 4 4 + + Mammary Gland - - - - - - - - - - -- - - - 4 4 4 . . . C + 4 + Ovary -----------------4 . 4 +4 + Pancreas Parathyroid + 4 ... 4 + ++4 . 4 4 # + 4 ... c + c c c c c + c c c c + c c c c ....4 c c Pituitary 4 4 + + c 4 + + + +,c + c 4 + 4 + C . . . . . . . Prostate SalivaryGland Bell.1Intestine . . . . 4 + + + + c + + t 4 - - -- - - - - - - - + * . c + 4 + + + 4 + 4 + + ... + 4 + 4 *.. + 4 + + ++ 4 +4 + Spin&! Cord Spleen ...4+ 4 + 4 + 4 + 4 + 4 + 4 + + + + + + 4 + 4+ + 4 4 + .. 4+ + Stomach Testis/Epididysis Thyroid + 4 + 4 .....4 4 4 ....... ...4+ .. 4 + + 4 4 4 -- - - - - - -- - * 4 c 4 ... + + c + 4 + 4 + 4 ... Trachea Urinary Bladder ....4+ . + + + c +++4 4+44#+ 4+ 4+4+4 + C 4 ...4 4 4 ... Uterus -----------------4 ...4 . Kesentary Skin Ureter The followingtissue(s)were not requirldby protocol-------------- -------------------------- - - - - -- - - - - -- - - - - -- - - - - - - ------------------------- A 4 indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentas made. 381 A c indicatesonly a nmdiagnostic commentwas @ado. Pleaserefer to the SingleTabulatedAnimalReport. Tissue InventoryPage: 217 Tissue Inventory(continued) RikerLaboratoriesI,nc. 3K FC-143:Two Year Oral Toxicity-OnCOginiciSttyudyin Rats Table:3 One Year Interim Project Number: 0201CROO12 Species:Rat Tissue Name DosiiBroup Nast: FC-143300 pps II III RR RRR - Animal Numbers - - - - 44444 66667 0a990 79294 ki F F F F F Adrenal Aorta Bone Marrato ..... ..... ..... Brain Esophagus ...4 + C 44++ Eye Heart Kidney LargeIntestine ...4 + + ...4 + ++4++ Liver +.+ . Lung Lymph Node (sesenteric) ++c++ Mammary Gland C .... Ovary ++ Pancreas 4. Parathyraid Pituitary Prostate C C ... +4. ----- SalivaryBlind +4. SmallIntestine +4. SpinalCard +4+++ Spleen Stomach Testis/Epididy@4.s ++ + ++ ...4 + --- -- Thyroid Trachea UrinaryBladder +c++c ...*+ +44+ Uterus +4+4+ Hosatary Skin Thefollowingtissue(sw)ere not requiredby protocol-------------- ------- ----- Ureter A 4 indicatesthata diaposis *as made. A - indicatesthatno diagnosisor commentwas made. 382 A i indi.cateosnly a nandiagnosticommentwas made. Pleasere4orto the SingleTabulatedAnimalReport. TissueInventoryPage:218 Tissue Inventory RikerLaboratoriesI,nc. 3N FC-143:Too Year Oral Toxicity-OncbgtniciSttyudyin Rats Project Number: 0281CROO12 Species:Rat Table: 4 Dose Group Kate: CONTROL 0 ppo III RRR ARRRRRRRARRRRRRRRRR Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - Tissue Name 55555555 55 555555555 11222222233333333344 44444 8913 456890123467 890124 570 Sol m n n N N N n n " N N x " x N N N N n N N " n n m Adrenal Aorta Bone Narrow Brain Esophagus ...4 .....4 + 4 + + 4 + 4 * .. 4 + 4 + + ... .........+ + + . 4 .. 4++c + + + 4 + 4 4 + + + . .. . .. . + . + c .......4 . 4 + 4 ... +++++ ++ 4 ... 4. Eye Heart + 4 +4 + + 4 ... c 4 # c ... 4c + ....... Kidney LargeIntestine Liver . . .. . 4 + + + + + 4 .....+ +44 444 ++ + + 4 + .. +4+++ 4 + 4 + 4 ...+ + + + + 4 + + ... 4 . Lung Lymph Node (sesenteric) Rimary Bland Ovary + 4 + 4 + 4 4 4 + 4 + 4 + 4 4 4 + .. 4+++ . . .4 C . . . .. . .. . .c + 4 + + + + + + ------------------------- ---- --------- ------------ Pancreas Pirathyraid Pituitary .....4 + 4 + + + + + 4 + C ...# + + 4 + + C4C+CC++C444+C+C CC+4+c++C ...4+ + + 4 + + + + + 4 + 4 + 4 + 4 + 4 + 4 + Prostate + + 4 4....C4 + 4 ......C C ..... SalivaryGland + 4 + 4 4 4 + 4 c 4 + 4 . . . . .. . . . . .. SmallIntestine ++. + + 4 + 4 + 4 .....4 + SpinalCard Spleen Stomach + 4 .. . 4 ... 4 + 4 +4 t .....4 .........4 + 4 + + + 4 + 4 + . .. + 4 + 4 .... .....4 4 + . . . Ttstis/Epididysis 4. 4 .........4 + c + 4 + 4 Thyroid C 4 . ....4 + 4 + + + C + C + + # + C + + + + Trachea UrinaryBladder ...4+ + . 4. 4+4. 4 .. . +#++ + +++ +4+#++ c c+ ++ + Uterus - - - - -- Thefollovingtissuetsw)ri notrequiredby protocol long Clitoral61&nd - - - - - - - - - -- - - - -- -- - - - - - - - ---------------------- --- HarderianGland ---- -- ---- -- ------ ------- Lymph Node ---------------------- --- Lymph Node (abdominal) --- ---------------------- Lymph Node (thoracic) ---------------- --- ------ Nesentary ------------------------- A + indicatesthata diagnosiswar,ude. A - indicatesthatno diagnosisor ement "as imde. 383 A c indicatesonlya nandiagnosticconsentwas sad#. Pleasereferto the SingleTabulatedAni"l Report. TissueInventoryPage:219 Tisr-utInventory(continued) Riker LaboratoriestInc. 3m FC-143:Two Year Oral tbxicity-OncollnicitSytudy in Rats Project Nueber: 0281CROO12 species:Rat Table: 4 Tissue Name PreputialGland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissuts (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose Group Nast: CONTROL 0 ppe Animal Numbers Sex R R R R R R R R R R R R R R R R R R R R R RR R - - - - -- - - -- - - - - - - - - - - - - - - 3 3 3 3 3 3 3 3.3 3 3 3 3 3 3 3 '@3)'3 3 3 3 3 3 3 5 5 5 5 5 5 5 55 5 5 5 5 5 5 5 55 5 5 5 5 5 5 5 1 12 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 44 4 0 9 1 3 4 5 6 6 9 0 1 2 3 4 6 7 8 9 0 1 "&4 5 7 9 8 N N x n N n N n " N N n N m " N n " n N " "N - - - - -- - - - - -- - - - - -- - - - - - - + ..............4 - 4 - - + - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - -- - - - - - - - - - - - - ---------------------- --- - - - -- - - - - -- - - - - - - - - - - - - --------------------- ---- - - - - -- - -- - -- - + - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- -- - - - - - - - - - - - - - - - - - - - - - - - A + indicatesthat a diagnosismas &ado. A - indicatesthat no diagnosisor comment was made. 384 A c indicatesonly a nondiagnosticcoutnt *as made. Please re4v to the Single TabulatedAnimal Report. Tissue InventoryPage:220 TissueInventory(continued) RikerLaboratorin,Inc. 3N FC-143:Two Year Oral Toxicity-NeoginicitSytudy in Rats Project Number: 0281CROO12 Species: Rat Table: 4 Dose Group Kul: CONTROL 0 ppe R R R R R R-R R R R R N R R R R R R R R R R R R R Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 33 3 3 3 Tissue Name 4 5 5 5 5 5 5 5 6 6 6 1 6 6 6 6 6 7 7 7 77 7 7 7 9 2 3 4 5 6 7 8 0 1 2 3 4 5 17 9 1 2 3 4 6 7 8 9 SIX " N N N " n m m n N " N N N n N " N N x n n " N N Adrtmal Aorta Bone Narrow Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lymph Node (mosenteric) Hastary Gland Ovary Pancreas Parathyraid Pituitary Prostate Salivary 61&nd Small Intestine Spinal Cord Spleen Stomach Testis/Epididysis Thyroid Trachea ...+ + + .......C .....4 ..... . . .. . 4 + 4 . C + 4 + 4 . . .. . . + 4 .....4 + C + + C + + 4 + 4 ..... + + + + 4 + + . . . . . .. + + 4 . + 4 + + + 4 . . . 4 + + C + 4 .. . . + 4 c + ... 4 + *c+ + + + * + 4 + + + 4 + + + 4 ...4 + . + ++ + + +44+++. 4 + + ... + + c 4 + 4 + + + 4 + 4 4 c . . .4 4 4 + + .4 + + . . . 4 4 4 + *. 4 ... + . . . 4 + # + + 4 + 4 + + . . .. . . .. . . . + + C ......4 + 4 + C ...4 4 + C .... - - - - -- - -- - -- - - - - -- - - - - - - - ------------------------- + 4C 4 ++ . c c+ ccc+ c4 c c + ccc c c ccc+*c +4+4. + + c ...c .....* + .....4 .......C ...4 + + + + 4 4 + + C + + 4 + 4 + + C 4 C C + * .. C +4++ + 4 C 4 .. . 4. C . . .. . 4 + 4 . . . ...4+ 4 . c + + c 4 * ......+ + + + + 4 . . . . .. . 4 . . . . . . . . . . . 4 + ...4+ + + + 4 + 4 + c 4 + +4 + +4 4 + # .. . . . . . 4+ C ........C 4 4 + C .... +4++ ++4+C 44 4 ... Urinary Bladder + 4 + + + 4 + 4 + 4 + + + t... +C+ Uterus The followingtissue(s)-we-re-n-ot-r-eq-ui-re-d-by-p-ro-to-co-l- - - - - - - - - - Bone ClitoralGland Marderian Gland Lymph NWe Lymph Node (abdominal) ------------------------- - - - -- - - - - - - - -- - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - -- - Lymph Node (thoracic) Hamtary ------------------------- - - - -- - - - - -- - -- - - - - - - - - - - A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor cment was made. A c indicatesonly a rmdiagnosticcment *as made. Please r@4erto the SingleTabulatedAnisalReport. Tissue InventoryPage: 221 385 TissueInventory(continued) RikerLaboratoriesI,nc. 3m FC-143:T*o Year oral Toxicity-oncoginicitSytudy in Rats Project Number: 0281CROO12 Species:Rat Table: 4 Tissue Name PreputialBland Skin Soft Tissues (abdomen) Soft Tissues (head) So4t Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus LlnidentifiTeidssue General Comment Dose 6roup Nam: CONTROL 0 ppe Anioal Numbers Sex R R R R R R -R R R R R R R R R R R R k R R P R R R ------------------ ---- --33333333333333 33333333333 55555555 555555 55555555555 455555556666666667777 777 7 92 34567B01234567912346769 N N N N n n N m N N N N N N N N n N "n N n N "n ------------------------- - - - - - - -- - -- - - 4 - 4 . . .. . . . . . ------------------------------ -- ---- -------------------------------- -- ----- -- --------------------------------------------- --- --------------------------------------------7 --- ------- -- ----------- A + indicatesthata diagnosisas made. A - indicatesthatno diapor,,iotr cowwt was made. 386 A c indicateosnly a nondiagnosticc@nt an side. Pliiasrseferto the SingleTabulatedAnisalReport. Tissue InventoryPage: 222 TissalInventory(continued$ RikerLaboratoriesI,nc. 3H FC-143:Tun Year Oral Toxicity-encogenicitSytudy in Rats Project Number: 0291CROO12 Species: Rat Table: 4 Tissue Name Bose Group Nast: CONTROL 0 ppo I I I I I 1-tI I I I I I I 1 1 1 1 1 1 1 1 1 1 1 R R R R R Pe R R A R R R R R R R R R R R R R R R R Anisal Numbers - - - - - - - - - - - - - - - - - - - - - - - - 4444444444444444444444444 5 5 5 5 5 5 5 5'5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 7778668889999999990000000 67 9 0 13 46 7 12 3 4 5 6 7 0 9 02 3 45 6 7 Sex F F F F F F F F F F F F F F F F F F F F F F F F F Adrenal .. . . 4 . . . . . . . . . . .. . . Aorta Bane Rarrom ...c ... .. . * + + . c 4 .......c + 4 + . ..........+ + Brain Esophagus ...4 + 4 + 4 + 4 + + 4 .......4 . + 4 + c .. ...4 4 +c+ c Eye +4+4. c cc+ *. Htart + 4 4 ... ...4 + + + + 4 ......... Kidney +++4+ 4...4+ + . 4+4+4+ Large Intestine +4 4+ . 4 4+ 4 +C . Liver ...4+ .......4 + * + ........ Lung ++ 4 4. + + + 4 + + + + .. 4 ++ + Lymph Node (sesentericl + C C C + + + C C + C + C C + 4 .....4 + Mammary Gland +4 + + . 4 + + + 4 ... 4. *+ Ovary ...4 + + c .....4 + 4 + + + 4 + 4 + c + Pancreas + 4 . .. . .. + 4 # 4 c 4 . . . . + 4 + 4 . . . Parathyroid ++ccccccccccccccccccccccc Pituitary Prostate .. . * . 4 + +4 4 + + .. 4+4+4+ - - - - - - - - - - - - - - - - - - - - - - -- - Salivary61ind c+ + +. c + 4 4+ c + + 4 ++c Small Intestine ...+ . 4 c 4 . . . . .4 + 4 . . . Spinal Cord + .. 4 + 4 4 4 + + 4 + 4 ...* ... Spleen + 4 ... 4 . + . * + 4 + 4 ... Stomach Testis/Epididyais ..... 4+44++4 4+4+4+4+4+ - - - - -- -- - - -- -- - -- - - - - - - - - Thyroid .....4 + 4 + + . + +++ Trachea + 4 . . .. .4 + 4 + 4+ + +4++4 UrinaryBladder Uterus + + 4 + 4@+ 4 + 4 + 4 + 4...44 4 + + # + + + 4 + + + 4 + 4 + 4 + 4 + 4 ...4 + The followingtissue(s)were not requiredby protocol Bon# Clitoral61and -- - - -- - - - - - - - - - - - - - - - - - - ------------------------ - Harderian 61imd ------------------------- Lymph VAde - - - - - - -- - - - - - - - -- - - - - - - - - Lymph Node (abdominal) ------------------------- Lymph kde (thoracic) - - - - - - -- - - - - - - - -- - - - - - - - - Nesentry ------------------------- A 4 indicatesthat a diagnosiswas made. A - indicatesthatno diagnosisor commentgas lade. 387 A c indicatesonly a nondiagnosticco.mentwas made. Pleaserefer to the SingleTabulatedAnisalReport. Tissue InventoryPage: 223 TissueInventory(continued) RikerL&boratoritiIgnc- 3" FC-143:Too Year Oral Toxicity-OncogtfticiSttYudy in Rats Project Nuiibtr:0281CROO12 Species:Rat Table: 4 Tissue Nast PreputialGland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Don Group Name: CONTROL 0 ppe Animal Numbers Sex R p N R R R-R R R R R R R R R R R R R R R A R A R - - - - - - - - - - - - - - - - - - - - -- - - 4 4 4 4 4 4 44 44 4 44 4 44 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 1 6 66 6 66 777aaa0869999999q90000000 6 7 90 13 4 6 7 12 3 4 5 6 7 8 9 0 2 34 5 67 FFFFFFFFFFFFFFFFFFFFFFFFF - - -- - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - ------------------------- - -- - - - - -- - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - -- - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - A + indicatetshata diagnosivsasmade.A - indicatetshatnodiagnosiosrcommenwtasside. 38 A c indicatesonly a nondiqnosticc@at *as ude. Pleasereferto the SingleTabulatedAnisalReport. Tissue InventoryPage: 224 TissueInventor(ycontinued) RikvrLaboratorin,Inc. 3K FC-143:I" yearOral7axicity-DncoggniciStyudyin Rats Table:4 Project Number: 0281CROO12 Species:Rat Dose Group Nast: CONTROL 0 ppe Tissue Name Animal Numbers Sax R R R R R R -A R R R R R R R R R R R R R R R R R R -------------- ----------- 444444 444444444444444 444 4 6666666b66666666666666666 011111111122 22 22223333333 9 123456789 123456783456789 FFFFFFFFFFFFFFFFFFFFFFFFF Adrenal Aorta . . .. . .. 4 + + + + + + + 4 + + . ...4 + C .....t+ + + 4 + + c 4 . . . .. Done Narrow Brain ...4 + 4 + 4 . 4+4 + 4 + + . 4 + 4 ... + Esophagus Eye + 4 + C ....C C t4 C 4 C 4 + + c+ 4 ++ + + c+ 4+ *c+ C C C C++C + c+. Heart Kidney .....4 + + + + . 4 + 4 .....4 . + + 4 .. 4 + 4 4 + 4 4 + + + 4 + + + 4 + + Large Intestine C * +C + *+ 4 . 4 + 4 + + + + 4 4 ..... Liver + 4 . . . + + 4 4 + + 4 . . . . . . .. . + Lung + 4 .....4 + 4 + + ... 4+4. . Lymph Node (sesenteric) .......4 + + 4 ....4 + 4 + 4 + 4 + 4 + Mammary Blind Ovary + 4 ....tC C ......4 + 4 + + + + * C + + + + 4 + + ......4 4 .. . 4 + + + 4 + Pancreas Parathyraid ...4+ . 4 4 + 4 + 4 .....4 ..... cccccccccccc+ccc cccccc +c+ Pituitary Prostate + + + + + 4 4 C 4 *-+ C + + + + * . C ++C + - --- -- --- --- ------ ------- SalivaryGland SmallIntestine ...4 + 4 * 4 ...4 + 4 ....C + C + 4 4 C + + + 4 + 4 + + + + .. +++++4. SpinalCord + 4 4 4 C + + 4 + + + 4 + + + C + 4 + 4 + 4 ... Spleen + 4 + 4...4+ 4 4 4 + 4 ...4 + + . .. Stomach Testis/Epididysis Thyroid .....4 + 4 .......4 .....4 4 4 4 --- ------- -- -- ---------- - + + 4 ...... + + ... Trachea. .....4 + 4 .....4 .....4 + + . UrinaryBladder + + 4 + ++ + + + +4*. +4+ + +++ + Uterus + 4 + 4 .....4 + 4 + 4 ....... Thefollowintgissue(sw)ri notrequiredby protocol--------- -------- ------------------------- Done ClitoralBlind ------------------------- --- --- -- ------ -- ---- ----- Hvderian Gland Lymph Nod# --- - - - - - - - - - - - - - - - - - - - - - - - Lymph Node (abdoeiR&I) ------------------------- Lymph Node (thoracic) ----------------- --- ----- Ntsentary --------------------- ---- 389 A 4 indicatesthata diagnosiswas sad#. A - indicatesthatno diagnosisor comment*as made. A c indicatesonly a nandiaposticcommentmas made. Pleas@re4orto the SingleTabulatedAnimalReport. Tissue InventoryPage:225 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FC-143: Two Year Oral Tozirity-OncogenicitYStudy in Rats Pro.ect Number: 0281CROO12 Species: Rat Table:4 Tissue Nast Preputial 61&nd Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (nick) Soft Tissues (thorax) Thymus UnidentifiedTissue General Conant Oose Group Name: CONTROL 0 ppe Anisal Numbers Sex R R R R R R -R R R R R R R R R R R R R R R R R R R - - -- - - - - - - - - - - - -- - -- - - - - 4 4 4 4 4 4 4 4 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 6 6 6 6 6 6 6 6 6 6 16 6 6 6 6 6 6 6 6 6 6 6 6 6 0 1 1 1 1 1 1 1 11 2 2 2 2 2 22 2 3 3 3 3 3 3 3 9 12 3 4 5 6 7 89 1 23 4 5 6 7 6 3 4 5 6 7 8 9 F F FF F F F F F F F F F F F F FF FF FF F F F - - -- -- - - - - - - -- -- - -- - -- - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - -- -- -- -- - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - -- - -- - - - - - - - - - - - - - - -- -- - - - - - - - - - - -- -- - -- - -- - - - - - - - - -- - -- - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - -- - - - - - - - - - - -- - - - - -- - - - - - - 390 A + indicatesthat a diagnosis*as made. A - indicates that no diagnosis or commentwas made. A c indicates Only a noftdiagnosticometnt was made. Please re4er to the Single TabulatedAnisal Report. Tissue Inventory Page: 226 TissueInventory(continued) RikerLaboratorim,Inc. 3H FC-143:Two Year Oral Toxicity-NcoginicitSytudy in Rats Project Number: 0291CROO12 species:Rat Table: 4 Tissue Name Dose Broup Name: FC-143 300 ppe Animal Numbers Sex RR R R R R R R R R R R RR R R R R R R R R R R R - - - - - - -- -- - - - - - - - - - - - - -- 33 3 3 3 3 3 3 3 3 3 3 33 3 33 3 3 3 3 3 3 3 3 5 5 5 5 5 5 55 55 5 5 5 5 & 6 6 6 6 6 6 6 6 66 88 68 8 8 9 9 9 9 9 9 9 9 0 00 0 0 0 0 0 0 1 1 1 2 3 S 6 7 0 1 3 45 6 7 9 0 12 3 5 6 7 8 9 0 1 N N N N N N N N N N N N NN N N8N N N N N N N N Adrenal . . . . .. .. . 4 + 4 + 4 + 4 + + + 4 + + + + + Aorta Bone Narrow grain Esophagus + 4 . . . + + + + 4 + 4 .. . . . 4 . . . . . . 4 . . . .. 4 + + + 4 C + + 4 C 4 + 4 + 4 . 4 + + 4 + + 4 4 . 4 + 4 + 4 + 4 + 4 ....... . . . .. . . c . . . . . . . . .. . . . 4 + + C Eye Heart Kidney + 4 . . . . .. .4 . . . . . . . 4 4 4 + + . .. . + . . . . . . . . .. . .. . . . . . . . . . . . . . . .. . . . . . . . . . . . 4 + Large Intestine Liver +4 + 4 + + + 4 + 4 + 4 + * + 4 ......... .... . . . . 4 . 4 + + . . . . . . . . . . . Lung + 4 + 4 + # + 4 + 4 + 4 + 4 ...4 + 4 ... Lymph Node (sesenteric) Mammary Blind Ovary Pancreas 4 + + ++ 4 + + + + + 4 4 4 +4 ++ + 4 + 4 + + - - - - - - -- -- - - - - - - - - - - - - -- - -- - - - - - - - -- - -- - - - - - - - - - - . . . . . . .. .. . . . . . . . . . . .. . . . Parathyroid Pituitary +c c c 4 c c + ++ +4 + + c + c + 4 c + c + + + 4 + + c + + 4 + 4 + + c . . . . . .. .. . Prostate SalivaryGland small Intestine +4 +4 + *4 4 + + 4 *+ + + 4 +4 + + + 4 + 4 + + c . . . . . . .. .. . 4 . . . . . . .. .. . + + 4 + + + 4 + + 4 .....4 4 + + 4 ...+ + Spinal Card .....+ + 4 + + C 4 + 4 C 4 + 4 + 4 + + + + + Spleen * . .. . . . 4 + + + 4 4 + + + .. . . . . . 4 + Stomach . . . 4 . . .. . .. . . 4 . . . . . . .. + + + Testis/Epididysis Thyroid ++ . 4++4 + c + 4 + + c . . .. 4 4 +4 + *+ + + + + + + .......4 + 4 + + c Trachea Urinary Bladder Uterus + 4 + + 4 4 .......4 4 ......4 4 + ...4 ... 4 .........4 .. . - - - - - - - - - - - - -- - - - - - - - - - - - The followingtissue(s)were not requiredby protocol--- --------------- Done - - - - - - - - - - -- -- - - - - - - - - - - - ClitaralGland - - - - - - -- - - - - - - - - -- - -- - - - - HarderianBland - - - - - - - - - - -- - - - - - - - - - - -- - Lymph Node - - - - - - -- - - - - - - - - - - - -- - - - - Lymph Node (abdominal) - - - - - - - - - - -- - - - - - - - - - - -- - Lymph Node (thoracic) - - - - - - - - - - -- - - - - - - - - - - - -- ksentary - - - - -- -- - - - - - - - - - - - -- - - - - 391 A + indicatesthata diagnosiswas made. A - indicatesthat no diagnosisor conent *as side. A c indicatesDBIY a nondiagnosticcommentmar,made. Please refer to the SingleTabulatedAnimalReport. Tissue InventoryPage:227 TissueInventory(continued) RikerLaboratoriesI,nc. 3" FC-143: Two Year Oral Toxicity-OncogenicitSYtudy in Rats Project Number: 0261CROO12 Species:Rat Table:4 Tissue Naze Proput4gal61and Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose group Name, FC-143 300 ppe Animal Numbers Sol R R R R R R-R R R R R R R R R R R R R R R R R R R - - - - -- - - - - - - - - - - - -- - - - - - 3 3 3 3 3 3 3 3 3 3 33 3 3 3 3 3 3 3 3 3 3 3 3 3 5 5 5 5 55 5 5 5 5 5 5 5 5 6 6 6 6 6 6 66 66 6 6 8a a e 8 9 9 9 9 9 9 q9 00 0 0 0 0 0 0 0 1 1 12 3 5 6 7 0 13 4 5 6 7 9 0 1 2 3 5 6 7 2 9 0 1 "NN N N N n n n N n xN n N "nN N N n """N - - - - - - - - - - -- -- - - - - - - - - - - - - - - -- - - - - - - - - - - - - -- - -- -- -- - - - - - - - - - - -- - - - - - - - - - - - - - -- - - -- - - - - - - - - - - - - - -- -- - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - -- - -- - - - - - - - - -- -- - -- - -- - - - - - - - - - - - - - ---- - - - - - - - - - - - - -- - -- - - - - - - - - - - - - - -- - - -- - - - - - - - -- - -- - - - - - - - - - - 392 A + indicatesthat a diagnosismas eadt. A - indicatesthat no diagnosisor commentwas Bade. A c indicatesonly a nandiagnosticcomment"S made. Please referto the Single TabulatedAnimal Report. Tissue InventoryPage: 220 TissueInventory(continued) RikerLaboratories,Inc. 3H FC-143:T*o Year Oral Toxicity-OntogenicitSytudy in Rats Project Number: 0281CROO12 Species:Rit Table: 4 Do&@ Group Name: FC-143 300 pps R R R R R R RR RR R R R R R R R R R RR R R R R Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - Tissue Name 6 6 6 66 6 6 6 6 6 6 6 6 6 6 66 6 6 6 6 6 6 6 6 I I I I1 1 22 2 2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 2 4 5 60 9 13 4 5 6 9 0 1 2 3 45 67 9 0 14 5 Sex m N m N n m N n N N N N n n N N x 0 n N N n N Adrenal Aorta Done Marro* Brain Esophagus Eye Hea!-t Kidney Large ln'6estine Liver Lun, Lymph Node (sesenteric) Mammary ilino. Ovary Pancreas Parathyroid Pituitary Prostate SalivaryGland Ssa'AlIntestine Spinal Cord Spleen stomach + 4 . .. . . . . 4 + 4 . . . . . . . . . . . . + + * 4 + + 4 .. . 4 . . . . . . . + + 4 . .. . .. . 4 + 4 . . . . . . .4 + 4 + + * + + 4 4 4 . 4 + + .. . .. . . 4 + 4 . + 4 + 4 +4 +* . 4+4+++4 + + + + + + + + + + 4 .. . .. . . . . . 4 . . .. . .. . . 4 . . . . . . . . . . . .. .4 . +4+4+ 4 . . . . .. . .. 4 . . . . . . . . . .. . . . 4 . . . . . . . . . . . ... . . . . . 4 + + + + + * . .....4 ++ * 4 + 4 + 4 + 4 ......... .. . . . . . . . . . . .. . . . . . . . . - - - - - - -- -- - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - + 4 . . . . . . .. . . . . . . . . . . c . .. . + + c . . . c . . . c . . . . .c 4 + + c 4 . ...# c . .. + c . . . . . . . . 4 . + C . .. . . . . . . . . . . .. . .+ . . . . . . c + c . . . . .. .. . . . . . c . . .. . . . . .. . . . . 4 . . . + . 4 + 4 ..... + + . . . . . . . . . . .+ . . . . . . . . .. . . . . 4 . . .. . . . . . 4 + + . . . . . . . . . . . . .. .. . . . . . . . . . Testis/Epididysis Thyroid Trachea Urinary Bladder + 4 + + 4 4 .. . . . 4 + 4 + 4 + + + 4 + 4 + 4 + + 4 . . . . . . . . . 4 + * .. . . . . . . . * + 4+4 +++. ++. 4 + 4 . .. 4 + + 4 .. . 4 . . . 4 + + 4 + 4 . . . . . . . . . Uterus ----------------T-he--follosingtis&uL,(&-a)r-e -n-ot-r-eq-ui-r-ed-by-p-ro-to-co-l------------------------ ---- Bane ClitaralGland HarderianGland Lymph Node - - - - - - - - - - - - -- - - - - - - - - - - - - -- - - - - - - - - - - - -- - -- -- - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - -- - -- - - - - - - - - - - - -- - - Lymph Node (abdominal) - - - - - - - - - - - - -- - - - - - - - - - - - Lymph kde (thoracic) - - - - - - - - -- - - - - - - - - - - - -- - - hosentary - - - - - - - - - - - - -- - - - - - - - - - - - 393 A + indicatesthata diagnosisiiasmade. A - indicatesthat no diagnosisor commentNis "do. A c indicatesonly a nondiagnosticcomment*as made. Pleaserefor to the SingleTabulatedAnimalReport. Tissue layntory.page:229 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 4 Project Number: 0201CROO12 Species:Rat Tissue Name PreputialBlind Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidenluifitTdissue General Comment Dose Group Name: FC-143 300 ppe I I I 1 1-11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 R R R R R R-R R R R R R R R R R R R R R R R R R R Anisal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - 3 3 3 3 3 3 33 3 - 1)3 3 3 3 3 3 3 3 3 3 3 3 33 3 6 6 6 6 6 6 16 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 I I I I 1 12 2 2 22 2 3 3 3 3 3 3 3 3 3 4 4 4 4 2 4 5 68 9 13 4 5 8 9 0 1 2 3 4 5 67 90 14 5 Sex N h N N N N N N N N N N N N N N M M N N N N N N N - - - - - - - - - - - - -- - -- - -- - - - - - - - - - - -- -- - - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - -- - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - -- -- - - - - - - - - - - - - - - -- -- - - - - - - - - - - - - - - -- - - - - - - - - - - -- - - -- - - - - - - - - - - - - -- - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - -: -- - - - - - - - - -- - -- - - - - - - - - 394 A + indicatesthata diagnosis*as made. A - indicatesthat no diagnosisor commentwas Bade. A c indicatesonly a nondiagnosticcommentwas made. Pleaserefer to the SingleTabulatedAnisalReport. Tissue InventoryPage: 230 Tissueinventory(continued) Riku LaboratoriesI,nc. 3H FC-143:Two Year Ural Toxicity-Cncog@RicitYStudy in Rats Project Nuabor: 0291CROO12 Species: Rat Table: 4 Dose Group Name: FC-143 300 ppe Tissue Name Anisal Numbers Set R R R R R R-R R R R R R R R R R R R R R R R R R R - - - - - - - - - - -- -- - - - - - - - - - - 4 4 4 4 44 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 44 4 6 6 6 6 6 6 6 6 6 6 6 6 66 66 6 6 6 6 6 1 6 4 4 4 4 4 4 4 4 5 5 55 5 5 5 6 6 6 6 6 6 6 77 7 1 3 4 5 6 7 B9 0 13 4 7 8 9 0 1 2 3 57 9 0 2 3 F F F F F F F F F F F F F F F F F F F F F F fF F Adrenal Aorta + 4 + 4 . . . 4 . . .4 + 4 + 4 + 4 . . . . . + + + + c . . .. . . . . . . c ++ Done Narrow .. . .. . . . . . . . . 4 . .. . . . . Brain Esophagus Eye Heart Kidney Large Intestine .....4 + 4 + + + + + 4 + + + 4 + + . 4+ c c + 4 + c .. . c c c + c c c c c + c c + + c + + 4 + + 4 4 C + 4 C + + C. . .. 4 ....... + + ... 4 . . .4 + 4 + 4 . . . . . . . . . . . . .. . . . . . . * . 4+ 4 +4 4 4 + 4 + . . . . . . c + + c . . .. . . . . . . . . . 4 + Liver '@ung Lymph Node imesenteric) +.+ 4 + 4 4 + 4 . . . . . . . . . . 4 . . . . . . + 4 + 4 ...4 + 4 + + + 4 + 4 + * + 4 + + 4 4 + C . . . . C . . . . . .. . 4 + + + C . Mammary Blind + 4 ....C * + 4 ..........tC C + + Ovary Pincreas Parathyroid Pituita,@y Prostate SalivaryGland Small Intestine Spinal Card Spleen Stomach Testis/Epididysis Thyroid Trachea c . .. . . . . . c . . .. . .. 4 + + + + + C . . . . . .. . . . . . . . . . . . . .. . + C + C C C C C C C + 4 + C + C C + t+ C C + C C ++ ++ + 4 + 4 +4 + 4+ 4 ++ 4 + + 4 + 4 ++ + - - - - - - - - -- - - - - - - - - - - - -- - - C . . . C 4 + C + C . . . C . . . .. . c . . . . *+ + C + + + + 4+ + . + + + + 4 .. . + 4 + 4 + 4 + 4 + 4 + 4 ...4 + 4 + + 4+ + + + . . . . .. . . . . . . . . . . . .. . . . . . . + + + * + + + + + + + 4 + + .. . . . . .. .. . - - - - - - -- -- - - - - - - - -- - - - - - - . .. . . c . . . c + + + c .. . . . . . C + C C .. . . + C . . . + + C . . . . .4 + 4 + c + UrinaryBladder Uterus + 4 C + '+ C + 4 + C + 4 C # + 4 + + + + + C . . . . .. . . . . . . . . . . 4 .. . . . . . 4 + The followingtissue(s)were not requiredby protocol------------------ - - - - -- -- -- - - - - -- - - - - - - - - - Done -- - - - - - - - - - - -- - - - - - - - - - -- ClitaralBland - - - - - - - - - -- - - - - - - -- - -- - - WarderianSland - - - - - - - -- - - - - - -- -- -- - - - - - Lymph Node - -- - - - - - - - -- - - - - - - - - - - - -- Lymph Node (abdominal) - - - - - - - - - - -- - - - - -- -- - - - - - Lymph NWe lthoracit) - - - - ---- - - - - - - - - - - - - - - - - - - Mosentary 395 A + indicatesthat a diagnosis*as made. A - indicatesthatno diagnosisor commentwas eadii. A c indicatesonly a nondiagnosticommentwas made. pleaserefer to the SingleTabulatedAnimalReport. Tissue Inventory Page: 23-1. TissueInventoryicontinued) RikerLaboratoriesI,nc. 3N FC-143:Too Year Oral Toxicity-OncogenicitSytudy in Rats Project Number: 0281CROO12 Species: Rat Table: 4 Tissue Name PreputiilEland Skir, Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Coment Dose Group Name: FC-14a 300 ppe II I I I I I I I I I I II I I I I I I I I II I R R R R R R R R R R RR R R R R R R R R R R RR R Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - 4 4 4 4 4 4 4 4 4 4 4 4 4 44 4 4 4 4 4 4 4 4 4 4 & 6 6 6 6 6 66 6 6 6 6 6 6 6 6 6 6 6 6 6 6 66 & 44 4 4 4 4 4 4 5 5 5 5 5 5 5 6 66 6 66 6 7 7 7 1 3 4 5 6 7 e 9 0 1 T.4 7 e9o12 3 5 7 2 0 2 3 Sex F F F F F F F F F F F F F F F F F F F F F F F F F - - - - - - -- - - - - - - - - - - - - - - - -- - - - - - - - - - - - - -- - - -- - -- - - - - -- -- - -- - - - - - - - - - - - - - - -- - - - - - - - - - - -- - -- - - - - - - - - - -- - -- - -- - - - - - - - - - - - - -- -- - - - - - - - - - - -- - - - - - - - - - - - - -- - - - - - - - - - - - -- - -- - -- - - - - - - - - - - - - - - - - - - ---- - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - -- - -- - - - - - - - -- - -- - -- - 396 A + indicatesthata diagnosistiesmade. A - indicatesthat no diagnosisor commentwas lade. A c indicatesonly a nondiagnosticCOGOIntisasmade. Please referto the Single TabulatedAnimalReport. Tissue InventoryPage:232 TissueInventory(continued) RikerLaboratoriesI,nc. 3K FC-143:Two Year Oral Toxicity-oftcogeniciSttyudy in Rats Project Number: 0201CROO12 Species: Rat Table: 4 Dose Group Name: FC-143300 ppe Tissue Name Animal Numbers Sex R R R RR R R R R R R R R R R RR R RR R R R R R - - - - - - - - - -- - - - - - - - - - - - -- 4 4 4 44 4 4 4 4 4 4 4 4 4 4 44 4 4 4 4 4 4 4 4 6 6 6 6 6 6 6 6 6 66 6 6 6 6 6 6 6 6 6 7 7 77 7 7 7 7 78 0 0 6 6 6 8 8 9 9 9 99 9 9 9 0 0 0 0 0 5 7 8 9 0 1 23 4 5 6 8 0 13 4 5 6 7 9 0 1 23 5 FF F F F F FF F F F F FF F F F F F F F F F F F Adrenal . . . .. . .. c . . . . . . . . . . .. . . . . Aorta ...4 + 4 + 4 C + + + 4 ....C .... Done Narrow . . . . .. .* . . . . . . . . . .4 Brain Esophagus .....4 . . . 44 4 + 4 + 4 + 4 .....+ + c c + c + c c c c c c 4 4 . . . . . . .. . c c c Eye ....c+ c + + 4+ + + 4 4 + 4 + 4C Heart +* 44 + + + 4 4 4 + 4 + + + + +4 Kidney . . . . . . .4 + + + 4 . Large Intestine 4 + 4 + C 4 C + + 4 . . . .. . + +++ Liver . . . . . .. . * . . . . . . . . . . . . .. . Lung ..........+ 4 .......4 + Lyaph Made (mosenteric) ....c + c + c + + 4 . . . . . . . . C Mammary 61and ........C + + C ......... Ovary + + +*+ + c 4 . . . . . . .. . . . . . Pancreas . . . . . . c . . . .. . . . . . c+ + Para4l-hyroid Pituitary Prostate C + C + C C C C C + 4 C 4 + C .. . .C C + + + . . . . . . . . . .. . . . . . . . . . . . .. . -- -- - - - - - - - - -- -- -- - - - - - - - SalivaryBlind Small Intestine . . . . . .oc + t C . . . + . . . . . . . . . . c +4 + 4 C 4 C + + 4 + 4 + 4 ++ + + Spinal Cord 44+ + +* . 4 + +.+ 4 4 + . . . . . . . 4 + Spleen + 4 + 4 + 4 + 4 + 4 4 4 + +.+ 4 . . . . . . . 4 + Stomach Testis/Epididysis + 4 + + 4 + C 4 + 4 + + 4 4 + 4 . . . . .. .4 + - - - - - - - - - - -- -- - - - - - - - - - - - Thyroid Trachea + + + + + 4 C 4 C + + 4 + 4 4 + + 4 + * C 4 +4 4 + 4 . . .. . . C . . . . 4 + 4 + + + + + + . UrinaryBladder + 4 c + + 4 c 4 4 . . . . . . . .. . . . . .. Uterus . . . 4 c + c . . . .. . . . . . . . . . 4 + 4 + --------long Thefollowingtissuo(s)*ere not requiredby protocol------------------- - - - - - - - - - -- - - - - - - - - - - -- - Clitural61and - -- - - - - - - - - - - -- - - - - -- - - - - Harderian Gland - - - - - - - - - - -- - - - - - - - - - - -- - Lymph Mode - -- - - - - - - - - - - - - - -- - - - - - - - Lymph Node tabdominal) - - - - - - - - - - -- - - - - - - - - - - -- - Lymph Node (thoracic) - -- - - - - - - - - - - -- - -- -- - - - - - Resentary - - - - - - - - - - -- - - - - - - - - - - -- - A + indicatetshatI diagnosiwsasaide.A - indicatetshatnodiagnosiosrcommenwtaseadt. 397 A c indicateosnlya nondiagnostciocniinwtasaide.PleaserefertotheSingleTabulateAdnisilReport. Tissue inventoryPage: 233 TissueInventory(continued) RikerLaboratorin,Inc. 3H FE-143:Two Year Oral Toxicity-OncoqtnicitSytudy in Rats Project Number: 0281CROO12 Species:Rat Table: 4 Tissue Name PreputialBland Skin Soft Tissues (abdomen) Sc4t Tissues (head) Soft Tissues lleg) So4t Tissues (nick) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Post Group Name: FC-143 300 ppe Anisal Numbers Six R R R R R R-R R R R R R R R R R R R R R R R R R R -- - - - - - - - - -- - -- - - - - - - - - - 4 4 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 44 4 44 6 66 6 6 6 6 6 6 6 6 6 6 6 66 66 6 6 7 7 7 7 7 7 7 7 7 0 8 6 9 88 6 8 9 9 9 9 9 9 1 9 0 0 0 0 0 5 79 9 0 12 3 4 5 6 6 0 1 34 5 6 7 9 0 12 3 5 FF F F F F F F F F FF F F F FF F F F F F F F F - - - - -- - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - -- - -- - - - - - - - - - - -- - - -- - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - -- -- - - -- - - - - - - - - - -- - - - - - - - - - - - - - - - - -- - A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentmas side. 398 A c indicatesonly a nmdiagftasticcommentwas made. Pleaserefer to the SingleTabulatedAnisalRepor6". Tissue InventoryPage: 234 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FC-143:Two Year Oral Toxicity-oncogeniciSttyudyin Rats Project Number: 0291CROO12 Species:Rat Table:4 Dose Sroup Name: FC-143 30 ppe I111rIII IIII11 111111 11111 R R R R R R-R R R R R R R R R R R R R R R R R R R Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - Tissue Name 6666666666666666666666666 4444555555555566666666667 67890 1234567890 1234567890 Sex N n " N N " K N N N N N N N n m n n N N n n N N Adrenal Aorta Bone Narrow Brain Esophagus Eye . . .. . . . + * . . . . .. . . . + + + + 4 + -------------------------- ------------ -- --------------------------------- + 4 + 4 + c + 4 + + + 4 + * + 4 . . .. .. . c + ------------------------- Heart Kidney Large Intestine Liver Lung Lymph Node (sesenteric) Maneiry Gland Ovary Pancreas Parathyraid Pituitary Prostate SalivaryGland SmallIntestine SpinalCard Spleen Stomach + 4 + 4 .. . . . . . + . . . . . . . 4 .. . . . . . . . . . . . . .. . . . . 4 + + + 4 . . . ---- ---- -------------- --- .... . . . . . . . . .. . . . . . . . . . . 4 + + + . + ................... ------------------------------------------------------------------------- c 4 c + + c + + + + + 4 ............. .....4 + + C + t + + C C 4 C + + C ...C + + 4 C . . . . . . .... .. . . . . . . . . . . . .......4 ................. 4 4 + 4 . . . + + 4 c co. . . 4 . 4++4C + ---------------------- --- ----- --- ----------------- .....4 + 4 + * + 4 . * ......... . . . 4 + + 4 4 ...... ..... ..... Testis/Epididysis Thyroid . . . . . . . . . . . . .. .4 + 4 . . . . . . . . . . . . . . . 4 4 . . . 4 + + c . . . .. . c + Trachea UrinaryBladder . .. 4 . . . . . . . . .4 + + . 4 ...C + . . . . .... . .. . . . . . . . . . . .C . . . Uterus The followingtissue(sw)-e-re-n-ot-r-eq-ui-r-edb-y-pr-o-to-co-l------------------------- Bone ClitoraBllind Harderian61&nd Lymph Node Lymph Node (abdominal) Lymph Node (thoracic) Hisentary --- ----------- -- ------------------ ------------------------------ --------------------------------- -------------------- -------------------------------------------------- --- 399 A + indicatesthata diagnosis*is made. A - indicatesthatno diagnosisor coalentwas made. A c indicatesonlya nondiagnosticcomot was made. Pleasere4orto the SingleTabulatedAnimalReport. TissueInventoryPage: 235 TissuIenventoriycantinued) RikirLiberitaritiI,nc. 3H FC-143:Tw Year OralToxicity-OncogenicitSytudy in Rats Project Number: 0281CROO12 Species:Rat Table: 4 Tissue Name PreputialGland Skin Soit Tissues (abdosen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose Group Name: FC-143 30 pps Animal Numbers Sex R R R R R R -R R R R R R R R R R R R R R R R R R R - - - - - - - - - - - - - - -- -- - - - - - - 3 3 3 3 3 3 3 3 33 3 3 : 3 3 3 3 3 3 3 33 3 33 6 6 6 6 6 6 6 6 6 6 6 6 1 6 6 6 66 6 6 6 6 6 6 6 4 4 4 4 5 5 5 5 55 5 5 5 5 6 6 6 6 6 6 6 6 6 67 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 V?4 5 6 7 9 9 0 0 N n "n N n "n"N "N "n N N N N N N N N H N - -- - - - - - - - - - - - - - - -- - -- - - - - - - - - - - -- - - - - - - - - - 4 + - - + -- - - - - - - - - - - - - - - - -- - -- - - - - - - - - - - -- -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - -- - - - - - - - - - - -- -- - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - -- -- - - - - - - - - - -- - - - - - - - - - - - - - - - -- -- - - - - - - - - - - - - - -- -- -- - - - - - - - - -- - - - - - - - - - - - - - - - A + indicatesthat a diagnosis*as made. A - indicatesthatno diagnosisor commentwas Bade. 400 A c indicatesOnly a nandiaqnosticommentwas made. Pleaserefer to the SingleTabulatedAn4&oa'RAeport. Tissue InventoryPage: 2.16 TissueInventory(continued) RikerLaboratoriesI,nc. 3" FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose Group Name: FC-143 30 ppe R R R R R Ri R R R R R R R R R R R R R R R R R R Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - Tissue Kate 7 7 7 7 7 7 7 77 86 9 9 9 9 9 8 9 9 9 99 99 9 1 23 4 5 6 7 8 9 0 12 3 45 6 7 6 9 0 12 3 4 5 Sex m N N N n N n n N N " N N N " m N N N N n N M Adrenal Aorta Bone Marrom Brai.n Esophagus Eye He art dney LL arge lr..t6esl;ne . . . . .. . . . 4 . . . . . . .. . . . . . . . - -- - - - - - - - - - - -- - - - - - - - - - - - - - - - -- -- - - - - - - - - - - -- -- - - -- - - - - - - - - - - -- - - - - - - - - - - C 4+++4C 4 + 4 . . .. . . . . .. C - -- - - - - - - - - - - -- - - - - - - - - - - . . . . . . . . . 4 .. . . . . . . . . . . . .. . .. . . . . . . . . . . .. . .. . . . . . . . - - - - - - - - - - -- - - - - - - - - - - -- - Liver . . .. .. . . . . . . . .. .. . . .. 4 + 4 + Lung Lymph Node (sesenteric) Missary Bl'i@id O,iary . . . . . . . . . . .. . . . . . . . . . 4 . - - - - -- -- - - - - - - - - -- - -- - - - - -- - - - - - - - - -- - - - - - - - - - - - - - - - - - - - -- -- - - - - - - - - - -- -- - Pancreas Pirat.',.yro4id .. . 4 . . . . . 4 . . . .. . C . . . . . . . . C C + C + + C .. . . . t 4 + 4 C C C C C . .. . Pituitary Prostal@e + 4 + + + 4 + + + +-+ 4 + 4 + 4 + + C . . . . 4 C . . . . . . . . . . .. . . . . C 4 . . 4+ SalivaryBlind Small Intestine Spinal Cord Spleen Stomach C 4 + 4 + 4 .. . . . 4 + + C C + 4 . ++ - - - - - - - - - - -- - - - - - - - - - - -- - - - - - - - -- - - - - - - - - - - - -- - - - - .. . 4 + . . . . . . . . .. . . . . . . 4 . + 4 . . . . .. . .. . . . . . . . . . .. . 4 + Testis/Epididysis Thyroid Trachea +4 + ++ + 4 4 4 *4 + + *+ 4 +4 + + + + + + C . . . . . . . . .. 4 .. . . . . . . + C 4 4 .. + . . . . . . .. . . . + + Urinary Bladder Uterus + 4 + 4 + 4 + 4 + 4 + + +4 .......4 +4 + - - - - - - -- - - - - - - - - - - - -- - - - - ---------------T-h-e followingtissue(s)mere not requiredby protocol------------------- Bone - - - - - - - - - - - - - - - - - - - - - - - - - ClitoralGland -- -- - - - - - - - - -- -- - - - - - - - - - HarderianGland - - - - - - -- - -- - - - - - - - - -- - -- - Lymph Node - - - - - - - - - -- - - - - - - - - - -- -- - Lymph Node (abdominal) - - - -- - - - - - - - - - - -- - - - - - - - - Lymph Node (thoracic) - - - - - - - - - - -- -- - - - - - - - - -- - Aesentary - - - - - - - - - - - - - - - - ---- - - - - - - A + indicatesthat a diagnosiswas Bad,. A - indicatesthat no diagnosisor commentwas made. 401 A c indicatesonly a nondiagnosticcomment*as &&do. Pleasereferto the SingleTabulatedAnimalReport. Tissue InvtntoryPage: 237 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FC-143:Too Year Oral Toxicity-oncogenicitSytudy in Rats Project Number: 0281CROO12 Species:Rat Table: 4 Tissue Name Preputial61and Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) So4t Tissues (nick) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose 6roup Nast: FC-143 30 ppe Anisal Numbers Sex R R R R R R-R R R R R R R R R R R R R R R A R R R - - - - - - - - - - -- - - - - - - - - - - - -3 3 3 3 33 3 33 3 3 3 3 3 3 3 3 3 3 3 33 33 3 6 6 6 6 6 6 6 6 6 6 66 66 6 6 66 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 79 86 6 8 8 8 8 6 9 9 9 9 99 9 1 2 T@4 5 6 7 8 9 0 1 2 3 4 5 6 7 6 9 0 1 2 3 4 5 N N n m n " n n " m "m n n " n " n m N N m N N " - - - - -- -- - - - - - - - - - - - - -- -- - - - - - - - - - - -- - -- -- - - - - - - - - - - - - - -- - 4 - - - - - - - - - - - - -- -- - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - ---- - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - -- - -- - - - - - - - - - - -- -- -- - - - - - - - - - - - - - - -- - - - - - - - - - - - - -- -- -- - - - - - - - - - - -- -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - - -- - 402 A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentwas made. A c indicatesonlya nondiagnosticCOmnt was made. Pleaserefer to the SingleTabulatedAnisalReport. Tissue InventoryPage: 238 TissueInventorylcantinued) RikerLaboratories,Inc. 3M FC-143:Two Year Oral Toxicity-OncogenicitSytudy in Rats Project Number: 0291CROO12 Species: Rat Table: 4 Dose Group Kass: FC-143 30 ppe Tissue Name Animal Numbers Sex R R R R R R-R R R R R R R R R R R R R R R R R R R -- - - - - - - - - - - - - -- - -- - - - - - 4 4 4 4 4 4 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 7 77 7 77 7 7 7 7 7 7 7 7 7 7 7 77 7 77 7 7 7 0 0 0 0 11 1 1 1 1 1 1 1 12 2 2 2 2 2 2 2 2 2 3 6 7 6 9 0 12 3 4 5 6 7 9 9 0 1 2 3 45 67 6 q0 F F F F F F F F F F F FFF FF F F FF F F F F F Adrenal Aorta Bone Narrow Brain Esophagus Eye . . . . .+ + + + 4 + 4 + 4 + + + + . ++++ -- - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - -- - - - + + . 4 . . . 4 C .. . . . . . . . . . . - - - - -- -- - - - - - 4 - - - - - - - - - -- Heart Kidney Large Intestine + 4 . . . . . . . . . 4 + 4 . . .. . . . + + + . . . . .. . .. . . . . . . . . 4 . . . + + - -- - - - - - - - - - - - -- -- -- - - -- - Liver +4 4 + + 44 + + . + ....... Lung Lymph Node (sesenteric) . .. . . 4+ 4 + + + . . .. .. . - - - - - - - - - - -- - - - - - - - - - - - - - Haseary Blind + 4 + 4 ++ +C + 4 + + + + + 4 C + C + + + ++ + Ovary Pancreas Parathyroid Pituitary Prostate SalivaryGland Small Intesti.ne Spinal Card Spleen ...44 + + .. 4 + 4 ........... + + + C + 4 + + C . . . . . . C . . . . . . .. . c cc c c + 4 + + c + + c c+ c + + c + c 4 + c+ . . . + . 4 . .. . . . . c . . . . . . . . . - -- - - - - - - - - - - - - - -- - -- - - - - . . . 4 . . . . . . .4 + c + c c + + 4 + + . - - - - -- -- - - - - - - - - - - 4 - - - -- - - - - - - - - - - - - - -- -- -- - - - - - - - . . . . + . . . .. .. . . . . . . . . . . .. . Stomach Testis/Epididysis + 4 + 4 + 4 + 4 + + + + + + . . . . . .. 4 . - - - - - - - - - - -- - - - - - - - - - - -- - Thyroid Trachea + + + + .. .. . . . . . . . . . . . . .. . . . .............+ + + .......+ + Urinary Bladder . . . . 4: 4 + 4 . . . . . . . . . . C 4 C 4 4 + + Uterus .. .+ + 4 . 4 + 4 + * + 4 +4 + 4 ... Bone ClitorilGland HarderianBlind The followingtissuit(sw)ere not requiredby protocol----------------- - - - -- -- - - - - - - - - - - - -- - - - -- - - - - - - - - - - -- - - - - - - - - - - - - - - - - -- - - - - - - - - - - - -- - -- - Lymph Node Lymph Node (abdominal) Lymph Node (thoracic) Resentary -- - -- - - - - - - - - - - -- - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - -- - -- - - - - - - - -- - -- - - - - - -- - - - - - - - - - - -- - - - - - - - - - - - 403 A + indicatesthata diagnosiswas made. A - indicatesthat no diagnosisOr consentgas sad@. A c indicatesonly a nondiagnasticcommentwas sad*. Pleasereferto the SingleTabulatedAnimalReport. Tissue InventoryPage: 239 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FC-143:Tue YearOral Toxicity-OneoginicitSytudy in Rats Project Number: 0281CROO12 Species:Rat Table: 4 Tissue Name PreputialGland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) SoiluTissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Coament Dose Group Name: FC-143 30 ppe Anisal Numbers Sex R R R RR R R R R R R R R R R R RR RR R R R R R - - - - - - - - - - - - -- -- - - - - - - - - 4 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 7 7 7 7 7 7 7 7 7 7 7 7 77 7 7 7 7 77 7 7 7 7 7 0 0 0 0 1 1 1 1 1 1 1 1 1 1 2 2 2 2 1&2 2 2 2 2 3 6 7 8 90 12 3 4 5 6 7 9 9 0 12 3 4 5 6 7 89 0 F F F F F F F F F F F F FF F F F F F F F FF F F - - - -- - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - -- - - - - - - - - - - - - - -- - - -- - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - -- - - - - - - - - - - - - - -- - - - - - - - - - - -- - -- - - - - - - - - - - - -- -- - - - - - - - - - - - - - - -- - 404 A + indicatesthat a diagnosisvas made. A - indicatesthat no diagnosisor commentvas side. A c indicatesonly a nondiagnosticcomment*as made. Pleasere4or to the Single TabulatedAnisal Report. Tissue InventoryPage:240 Tissueinventory(continued) RikerLaboratoriesI,nc. 3H FC-143:Ta YearGrilToxicity-OncogeniciStyudyin Rats Project Number: 0291CROO12 Species:Rat Table:4 Tissue Name Dose group Name: FC-143 30 pps IIIIII IIIIIIIIIIIIIItIIII RRRRRRARRRRRRRRRRRRRRRRRR Anisal Numbers - - - - - - - - - - - - - - - - - - - - - - - - 44444 444444444444444 44444 7777777777777777777777777 33333333 344444444445 55553 12345&7890 1234 567890 12345 Sex F F F F F F F F F F F F F F F F F F F F F F F F F Adrenal Aorta Bone Narrow Brain + 4 .. . 4 .. . . . . . 4 + 4 + 4 + * + 4 + ------------------------- ------------------------- - - - - - - - - - - - - --- - - - - - - - - - - - Esophagus Eye + 4 + 4 + 4 . . .. . c + + c + + c + + + 4 + + c -- ----------------------- Heart + 4 + + . . . . . . .4 . 4 ......... Kidney Large Intestine . . .. 4 . . . . . . . . + + . 4 +4 + 4 + ------------------------- Liver Lung Lymph Mode (sesenteric) Hiseary Gland . .. . . . . . . 4 + 4 + 4 . . . + 4 4 . . . . . . . . 4 .............4 ....... ---- ---- ---------------- - .....4 + c c ..... .. ...4 + + . ovary + *+ + 4+ + + + 4 ..... + Pancreas Parithyroid . . .4 + 4 C 4 + 4 + C . . .4 C + + 4 + + . ....c c...cc c + 4 + + + c + c + 4 + + c Pituitary Prestal@e . . . . . 4 + C + + I- 4 + C + + . . . . . . . . . ------------------------- SalivaryGland C 4 + 4 + + + 4 + 4 . . . . . . . . . 4 .. . SmallIntestine SpinalCard -------------- -------------------------------- --- Spleen + 4 + + + 4 . . + c . . . 4 .... ..C + + Stomach Testis/Epididysis .......4 4 .......4 . ----- --- ----------------- Thyroid Trachea ...4 + c .....c + 4 . c + c ....c . . . . . ... . . 4 + c . . . . . c . . .. . .c UrinaryBladder Uterus + 4 + + + 4 . . . . . . . 4 . . .. . . . . . . . ......C .................. The followintgissue(sw)re not requiredby protocol---------------- Done ClitoralGland HarderianGland Lymph Node Lymph Mode (abdominal) -------------------------------------------- -- ---------------- ---------- ---------------------- --------------------- Lymph Node (thoracic) Resentary ------------ ------------------------------- ------ 405 A 4 indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentwas made. A c indicatesonly a nondiagnosticcommentwas made. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage: 241 Tissue Inventory(continued) RikerLaboratoritsI,nc. 3H FC-143:Too Year Oral Toxicity-OncogenicitSytudy in Rats Project Number: 0281CROO12 Species: Rat Table: 4 Tissue Nast Preputial61and Skin Soft Tissuts tabdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (nick) Soft Tissues (thorax) Thymus UnidentifiedTissue 6entralConant Dose 6roup Name: FC-143 30 ppe Animal Numbers Sex R R R R R R-R R R R A R R R R A R R R R A R R R R - - - - - - - - - - -- - - - - - - - - - - -- 4 4 4 4 44 4 4 4 4 4 4 4 4 44 44 4 4 4 4 4 4 4 77 7 7 7 7 7 7 7 7 77 7 7 7 7 7 7 7 7 7 7 77 7 3 3 3 3 33 3 3 3 4 4 4 4 4 4 4 44 4 5 5 5 5 5 5 12 3 4 5 6 7 6 9 0 12 3 4 5 6 7 8 9 0 1 2 34 5 F FF F F F F F F F F F F FF F F F F F F F F F F ---- - - - - - - - - - - - - - - - - - - - - - - -- - + - - + + - - - + -- - + - + - + - - - + - - - - - - - - -- -- - - - - - - - - - - -- - -- - - - - - - - - - - -- - - - - - - - - - - - - - -- -- - - - - - - - - - - - - - - -- - - - - - - - - - - -- - -- - - - - - - - - - - - - - -- - - - - - - - - - - -- -- -- -- - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - -- - - -- - - - - - - - - - - -- -- - 406 A + indicatesthat a diagnosisvis made. A - indicatesthat no diagnosisor commentmas Bade. A c indicatesonly a nandiagnosticCUA@nt was udlo. Please referto the Single TabulatedAnimal Report. Tissue InventoryPage: 242 APPENDIX ITEM E STATISTICAL METHODS 1. For memo dated February 11, 1985; see Tables 12-18 2. For memo dated September 24, 1985; see Tables 19 and 20 407 InternCaolrrespondence Appendix Item E To:CtiuckF. Chesney --Riker Path and Tox - 270-3S-05 From:Sally E. McCarville - Riker Res Data Ops - 270-3A-01 SubjecStt:atistical Analysis for FC-143 in Rats Date:February 11, 1985 The laboratory values and organ weight data for the study of fluorocarbon FC-143 in rats have been analyzed, and the results are presented in the attached tables. The statistical methods used to analyze the data are described in the following paragraphs. Statistical Methods The means and standard deviations for percent organ weight to body weight ratios, organ weight to brain weight ratios, and laboratory data were determined separately for each sex and dose group. These data were analyzed using Bartlett's test for homogeneity of variance. If this test was not significant at a = 0.001, the data were further analyzed by comparing each treated group to the control group using a two-tailed Dunnett's test at the a 0.05 significance level. The results of Dunnett's test have been indicated by asterisks on the mean tables. If Bartlett's test was significant at a = 0.001, the data were ranked and a two-tailed Dunnett's test was performed on the ranks. These results have been indicated by the pound sign on the mean tables. References Bartlett's Test Anderson, V.L. and McLean, R.A. (1974), Design of Experiments: A Realistic Approach, New York: Marcel Dekker, Inc., 16-22. Dunnett's Test Winer, B.J. (1971), Statistical Principles in Experimental Design, New York, McGraw-Hill Book Company, 201-204. 408 Appendix Item E Page 2 Statistical Analysis for FC-143 in Rats SEM:emr 02/11/85 Rank Transformations Conover, W.J., and Iman, R.L. (1981), "Rank Transformations as a Bridge Between Parametric and Nonparametric Statistics", The American Statistician, Vol.35, No. 3, 124-129. If you have any questions regarding the analyses, please let me know. @z Ot SEM :emr Att. c: Cathy E. Ludemann L6K-,r.@-Sibinski MEE/RWH 4U9 IntemalCOmsporidence APPENDIX ITEM E TO: L. J. Sibinski - Riker Path a6d-Tox - 270-3S-05 Fom: S. E. McCarville Riker Res Data Ops - 270-3A-01 Subject: StatisticalAnalysis of MicroscopicFindings for FC-143 in Rats oate: September 24, 1985 The major microscopic findings of the Two Year Oral (Diet) Toxicity-OncogenicityStudy of Fluorocarbon FC-143 in Rats were statisticallyanalyzed.For each organ/lesionclassification the sexes were analyzed separately using a two-tailed Fisher's Exact Test comparing each treated group to the controls.An a= 0.05 significancelevel with Bonferroni's adjustment for multiple comparisons was used within each organ/lesion/sexcategory. If the expected value of each cell was greater than 20,-then Yates' corrected Chi-Square test was used. An asterisk on the summary tables indicates a significantdifferencebetween the controls and the treated group. References Fisher's Exact Test: Conover,W. J., (1971), PracticalNonparametricStatistics, New York, John Wiley and Sons Inc., 162-164. Yates' Corrected Chi-Square: Fleiss, Joseph L., (1973), StatisticalMethods for Rates and Porportions, New York, John Wiley and Sons Inc., 14-15, 19-20. S. E. McCarville :mjm c: MEE/RWH 410 APPENDIX ITEM F GROUP MEAN BODY WEIGHTS, INDIVIDUAL'BODY WEIGHTS AND FEED JAR WEIGHTS OF MALE RATS RECEIVING F-LUOROCHEMICAL FC-143 IN DIET FOR TWO YEARS NOTES: Code 1 indicates a control group rat weight Code 2 indicates a FC-143 - 300 ppm group rat weight Code 3 indicates a FC-143 - 30 ppm group rat weight Codes 11, 12, 13 indicatesthe total feed jar weight for the previous rat All weights are in grams 411 APPENDIX ITEM F Two Year Oral (Dist) Toxicity - oncogenicity Study of Fluorocarbon FC-143 in Rats Group Mean Body Weights (g) + Standard Deviation Males Study Week 0 2 4 6 8 10 12 14 16 is 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Control - 0 ppm Mean BW + SD (N) 300 ppm Mean BW + SD (N) 30 ppm Mean BW + SD (N) 165.3 + 10.5 270.9 16.4 334.0 25.1 390.7 31.0 429.2 + 37.3 456.2 42.7 475.5 + 43.4 493.2 -; 47.7 502.9 + 48.9 515.3 + 48.7 526.8 542.3 49.5 52.1 550.4 + 53.0 561.0 + 54.3 567.5 + 55.0 576.3 56.7 580.6 57.4 582.9 + 62.5 591.0 + 59.7 599.4 59.4 608.4 61.6 612.9 61.2 619.8 + 62.3 623.5 64.3 626.1 63.4 639.2 67.0 638.6 70.1 (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (64) (64) (64) (64) (64) (64) (64) (64) (64) 162.1 + 11.0 *234.3 + *276.7 + 21.7 31.8 *308.6 ; 38.6 *353.2 + 39.7 *380.1 44.9 *398.0 46.7 *412.8 47.4 *425.4 47.5 *436.0 + 48.4 *447.4 48.7 *456.1 48.9 *464.2 49.4 *475.0 + 49.4 *484.9 + 51.4 *497.2 51.8 *505.7 52.5 *511.8 52.5 *514.2 53.1 *524.8 53.2 *535.2 56.0 *540.9 57.9 *550.8 + *552.0 58.0 61.2 *558.5 64.0 *566.7 64.7 *570.1 + 66.2 (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (64) (64) (64) (64) (63) (63) (63) (63) (63) (63) (63) (63) (63) (63) (63) (63) (63) 167.0 + 9.8 271.0 14.7 328.5 + 22.9 *369.4 ; 30.8 *410.3 + 37.1 441.5 44.2 458.1 47.5 475.4 + 48.6 487.9 -; 52.5 498.5 + 52.8 512.1 ; 53.6 *519.4 + 54.7 *526.3 + 56.7 538.9 ; 59.7 546.2 + 61.8 558.6 61.3 566.4 62.3 571.3 + 63.3 575.4 64.6 584.0 65.6 592.5 69.0 600.5 69.1 610.4 69.7 612.1 71.0 618.9 72.3 627.1 74.2 633.6 76.2 (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (49) (49) (49) (49) (49) (49) (49) Number of animals vaighed Significant difference from Control at the 5% level (Dunnett's t Test; a - 0.05) 412 APPENDIX ITEM F Two Year Oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon FC-143 in Rats Group Mean Body Weights (g) +-Standard Deviation Males Study Week 54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 88 90 92 94 96 98 100 102 104 Control - 0 ppm Mean BW + SD (N) 300 ppm Mean BW + SD (N) 654.3 661.6 668.0 673.2 674.4 664.5 650.8 656.6 661.9 658.3 660.8 667.7 668.8 670.6 663.1 668.1 675.6 678.9 690.0 686.0 678.3 677.5 675.7 671.1 665.9 642.0 + 75.3 73.3 + 76.4 + 75.4 -; 77.4 + 77.6 + 78.1 + 82.9 84.7 86.3 + 81.7 + 84.9 + 83.8 ; 85.2 + 85.5 + 88.8 + 86.8 + 86.4 + 93.9 91.6 90.3 95.1 + 98.6 ; 94.4 + 101.2 + 99.5 (49) (48) (48) (48) (48) (47) (47) (47) (47) (47) (46) (46) (46) (46) (46) (45) (42) (41) (41) (40) (40) (38) (38) (37) (36) (35) *577.6 + 69.8 *583.1 71.2 *587.9 73.9 *590.8 + 75.9 *593.2 74.9 *596.8 80.8 *598.2 80.8 *604.9 + 83.0 *608.2 79.9 *608.5 -601.1 76.5 76.5 *605.4 76.6 *604.6 + 77.5 *611.8. 76.7 *610.0 + 77.1 -617.5 + 79.1 *617.4 *78.8 *614.7 83.0 *624.6 87.3 *621.8 85.6 -627.6 80.8 *621.0 84.6 627.2 + 80.8 625.5 87.5 629.4 88.0 613.3 88.1 (48) (48) (48) (48) (48) (48) (48) (48) (48) (46) (46) (46) (46) (46) (46) (46) (46) (46) (45) (45) (45) (45) (45) (44) (44) (44) 30 ppm Mean BW + SD (N) 641.9 646.4 652.7 656.8 655.7 658.3 662.5 666.5 666.2 664.4 659.2 663.8 661.7 669.2 666.9 662.3 664.5 654.7 662.4 652.9 660.0 653. 4 659.7 660.0 664.0 650.8 + 76.9 78.6 78.2 79.5 82.1 84.7 + 82.0 + 84.0 86.8 86.3 + 83.9 ; 86.0 + 89.3 88.0 87.0 + 92.6 + 95.7 102.3 100.5 + 103.5 ; 86.1 + 87.0 + 88.8 94.8 93.2 95.0 (49) (49) (49) (49) (49) (49) (47) (47) (45) (45) (45) (45) (45) (45) (45) (45) (44) (44) (43) (43) (40) (39) (38) (38) (37) (36) Number of animals weighed Significant difference from Control at the 5% level (Dunnettle t Test; a a 0.05) 413 TWO YERF, STUDY OF Fi-i---,*92#4-.F(-@-:14--J,r-iP.FiT'-z TEr-Ht4ICIA?4 INITIFILS:S MH EIRTE:S SE'.' 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FOODJAR IR03593 FOOE)JAR IR03594 rriODJRR 03595 FOODJAR IP02596 FOODJAR iRO3597 FOOD-JRR iRO-@1598 RAT # FOODJAR IR03599 TFi FOODJAR iRO3600 FOODJAR IR03601 FOODJAR IR03602 FOODJAR IR03603 FOODJRR IR01604 RAT # 125 02S 12S 02S 12S Oc-@S i2S 02S 12S 02S 12S 025 12S 02S 12S 02S12S 02S 125 02S 125 02S 12S 02S FOODJRR IR03605 FOODJRR IR03606 FOODJRR IR03607 TA FOODJRR iRO3608 FOODJAR IR03609 FOODJAR IR036iO FOODJFIR TA IP03611 FOODJAR IR03612 TA FOODJAR IR03613 RAT # FOODJRR IR036i4 FOODJAR IR03615 FOODJRR iRO3616 FNODJAR 03617 RAT # FOODJAR IR03618 12S 02S 12S 02S 12S 02S 12S 02S 125 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S e2S 12S 02S 0.07 iRO3592 025 0.02 554.91 331.83 69rd.94 371.39 562.34 401.32 756.87 374.96 588-53 402.71 0.04 iRO3598 02S 0.03 ' 634.39 ' 0 397.81 ' 622.46 ' 397.52 ' 656.42 ' 391.59 ' 649.96 ' 3e9.25 ' 646.11 ' 391.85 ' -0.08 IR03604 02S -0.00 570.21 395.41 511.69 431.00 658.57 0 390.84 670.47 386.68 584.57 397.33 712.50 371.38 0 684.35 382.33 658.29 0 389.46 -0.01 IR03613 02S 0.01 513.:Ll 399.04 602.15 ' 390.68 ' 608.55 ' 400.37 ' 0.16 IP036i7 02S 0.26 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 a 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 0 12 2 12 2 12 2 12 0 2 12 2 0 :L2 2 12 2 12 -2 I.;@ 2 :L2 2 1.2 2 0.07 0.04 -0.08 -0.01 0.16 0.07 NOT ON 0.02 554.91 331-83 690.94 371.39 562-34 401.32 756.87 374.86 588.53 402.71 0.04 NOT ON 0.03 634.39 STUDY STUDY 387.81 622.46 397.52 656.42 391.59 649.96 389.25 646.11 391-85 -0.08 NOT ON 0 570.21 395.41 511.69 431 658.57 STUDY 3@0.94 670.47 386.68 584.57 397.33 712.5 371.38 694.35 382.33 658.29 389.46 -e.ot NOT ON 0.01 513.11 399.04 --602.15 380.68 608.55 40rd.37 e.i6 NOT ON 0.26 791.20 STUDY STUDY 719 FOODJAR 12S IR03619 025 FCOOE-I'AR 125 IR@3620 e2S PFIT # 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FOODJAR 13S IR03658 03S FOODJRR 13S IR03659 03S TR FOODJAR 13S IR03660 03S FOODJAR i3S IR03661 03S FOODJAR 135 IR03662 03S FOODJAR 13S IR03663 03S FOODJAR 13S IR03664 03S FOODJRR 13S iRO3665 03S RAT # FOODJAR 13S IR03666 03S FOOE)JAR 13S IR02667 03S FOODJAR 13S iRO3668 03S FOODJAR 13S IR03669 03S RAT # FOODJAR 13S TA IR03670 03S FOODJAR 13S iRO3671 03S FOODJAR 13S IR03672 03S FOODJRR 13S 03673 03S FOODJAR 13S IRO!674 03S FOODJAR 13S IR03675 03S FOODJAR 13S IR03676 03S FOODJAR 13S 56L-4.47 ' 444.69 ' -0.04 JR03648 03S -0.05 671.35 391.40 572.46 398.94 712.38 378.50 754.95 389.25 685.12 39:1. 48 715.8:1 390.05 649.:LS 391.iS 688.66 386.49 -0.13 IR03657 03S -O.:L2 6:19. 6L-4 411. 60 737.37 0 377.10 729. :L5 3et.97 676.24 388.92 423-23 414.64 707.13 0.00 566.68 399.87 -0.02 IR03665 03S 0.01 385.94 542.43 415.56 549.39 417.50 0.16 IR03669 03S 0.15 a 741.19 381.54 648.15 390.40 709.25 387.33 651.20 403.60 784.89 387.67 697.58 344.59 747.82 379.76 13 3 13 3 13 3 13 3 13 3 :13 3 1.3 3 :L3 3 13 3 :L3 3 13 3 :L3 3 0 :L3 3 13 3 13 3 13 3 13 3 13 3 13 3 13 3 13 3 13 3 13 0 3 13 3 13 :r 13 3 13 3 13 3 13 3 13 -e.04 _O.i3 -O.e2 0.16 560.47 444.69 -0.04 NOT ON STUDY -0.05 671.35 391.4 572.46 296.94 7:12. 38 378.5 754.95 389.25 685.1.2 39:L.48 715.91 390.05 649.iS 391..:LB 698.66 386.49 -O.:L3 NOT ON STUDY -0.12 619. 6 4:L:L.6 737.37 377.1. 729.15 381.97 676.24 388.92 423.23 414.64 707.13 or 566.6e 399.87 -0.02 NOT ON e.ei 676.54 385.94 542.43 415.56 549.39 417.5 e.is NOT ON 0.15 STUDY STUDY 741.ie 381.54 ..648.15 3ge.4 709.25 387.33 651.2 403.6 784.89 387.67 697.58 344.58 747.82 379.76 721 iRO3677 03S FOODJAR 13S IR03678 03S RAT # FOODJRR 13S 4QO3679 03S FOODJAR 13S IR03680 03S FOODJRR 13S IR03681 03S FOODJAR 135 1R03682 FOODJRR i3S iRO3683 035 FOODJAR 13S IR03684 03S FOODJAR 13S iRO3685 03S FOOE)JAR 135 iRO3686 03S FOODJAR 13S IR03687 03S FOODJAR 13S IR03688 03S TA FOODJAR 13S IR02689 03S FOODJAR 13S iRO3690 03S FOODJAR 13S IR03691 03S FUODJAR 13S IR03692 03S FOODJAR 13S IR03693 03S FOODJAR 13S iRO3694 03S FOODJRR 13S IR03695 03S FOODJRR 13S 9999999999 659.75 ' 415.91 ' -0.04 ' IR03678 03S -0.03 839.8 0 362.56 721.38 382.92 640.16 415.06 754.91 339.76 386-91 634.67 395.40 734.95 377.16 704.28 41e.i6 720.71 0 370.55 489.25 412.26 ' 638.91 ' 393.29 ' 588.32 ' 401.74 ' 531.23 ' 425.77 ' 795.98 ' 371.78 ' 657.49 ' 393.54 ' 729.17 ' 384.42 99 3 13 3 -0.04 13 3 0 13 3 13 3 13 3 13 3 :L3 3 13 3 13 3 13 3 13 3 0 13 3 13 3 13 3 13 3 13 3 13 3 13 3 13 -0 659.75 415.91 -0.04 NOT ON -0.03 839.8 STUDY 362.56 721.38 382.92 640.16 393.96 536.69 415.06 754.91 339.76 762.52 386.91 634.67 395.4 734.95 377.16 704.28 418.16 720.71 370.55 489.25 412.26 638.91 393.29 588-32 401.74 531.23 425.77 795.98 37:L.78 657.49 393.54 729.17 384.42 722 TWO YEAR ORRL<DIET) TOX-ONC STUDY OF FM-3924 & FC-143 IN RATS EXP.# 0281CROei2 TEC:HNICIAN INITIRLS:S SW TODRY-'S DATE:S 9/7,,*82 SEX OF RRTS:S MALE ROOM NUMBER:S D-340,D-338 WEIGHT OF FULL FOOD JAR:S 550GRRMS WEEK 72 IR035i6 RAT # FOODJAR 015 itS IR03517 OIS RAT # FOODJRR IIS iRO3518 SIS FOOE)JRR IIS IR03519 015 FOODJRR IR03520 RAT # FOODJAR ilS OIS liS IR0352i FOODJAR IR03522 PAT # OIS IIS eis FOODJRR LIS IR02523 OIS FOODJAR IIS IR03524 OiS FOODJRR IIS IR03525 FOODJAR OiS liS IR03526 OIS FOODJAR 115 IR03527 OIS RAT # FOODJAR liS IR03528 OIS FOODJAR IIS iRO3529 FOODJAR OIS 1-tS IR03530 OIS FOODJAR IIS IR03531 SIS FOODJRR LIS iRO3532 SIS FOODJAR IIS iRO3533 OIS FOODJAR ILS '@02534 OiS . ADJRR 115 IR03535 OIS RAT FOODJRR IIS -0.03 " IR02516 OIS -0.04 ' -0.01 IR03517 OIS -0.02 611.42 401.44 697.63 394.77 -0.02 IR03520 OiS -0.02 518.54 441.51 -0.00 IR03522 OIS -0.03 750.66 390.41 615.50 393.66 606.63 399.30 673.71 397.98 -0.00 IR03527 OIS 0.01 sol.88 390.41 743.64 396.30 649.27 392.36 673.79 387.14 647.73 405.22 700.85 395.63 787.41 370.43 0.04 iRO3535 OIS 0.01 1 -0.03 It 1 -0.01 It 1 It 1 11 1 -0.02 11 1 It 1 -o.oe 11 1 11 1 11 1 11 1 11 1 -0.00 1:1 I 11 1 11 1 it 1 It 1 It -1 11 1 11 1 0.04 11 iRO3536 OIS 559.24 1 TH 0 0 -0.03 NOT ON STUDY -0.04 -0.01 NOT ON STUDY -0.02 611.42 401.44 697.63 394.77 -0.02 NOT ON STUDY -0.02 518.54 441.51 0 NOT ON STUDY -0.03 750.66 390.41 6i5.5 393.66 606.63 399.3 673.71 397.98 0 NOT ON STUDY rd.ei so:i.ee 390.41 743.64 396.3 649.27 392.36 673.79 387.14 647.73 700.85 395.63 787.41 370.43 0.04 NOT ON 0.01 STUDY 559.24 723 FQOC,jriF;: ilS IR03537 OiS FUODJAR liS IR03538 OIS FOODJRR ilS IR03539 OIS FOODJAR IIS 3-540 OIS FOODJAR 430. 37 4SC1.61 494.07 764.15 391.12 604.58 404.41 IR03541 OIS FOODJRP IIS IR03542 OIS FOODJRP 115 iRO3543 OIS RAT # FOODJRR IIS IR03544 OIS FOODJAR LIS IR03545 FDODJAR IR03546 RAT # FOODJAR OIS IIS OiS liS IR03547 OIS FOOE)JAP IIS iRO3548 OIS TF4 FOODJAR iiS IR03549 OIS FOODJAR IIS iRO3550 015 RAT # FOODJAR IIS IR03551 OIS RAT # FOODJAR IIS IR03552 OIS FOODJAR IIS IR03553 OIS FOODJAR IR03554 FOODJAR IR03555 liS OIS IIS OIS FOODJRR IIS IR03556 OIS TA FOODJAR IIS IR03557 OIS FOODJAR LIS iRO3558 OIS FOODJAR IIS IR03559 OIS RAT # FOODJRR IR03560 IIS OIS RAT * FOODJRR IIS 03561 elS t-jODJAR 115 IR03562 OiS FOODJRR IR0356-; FOODJAR IR03564 FOODJAR itS eis LIS 015 IIS 62:1.94 399.26 ' 646.43 ' 407.50 ' -0.02 IR03543 OIS 0.02 746.72 379.:18 673.70 402.00 0.04 IR03546 OIS 0.03 759.20 402.20 767.95 0 383.43 593.40 397.88 -0.03 IR03550 OIS -0.06 -0.04 IR03551 OIS -0.04 7:L9.24 383.50 700.:19 38:L. 49 5:12.62 419.08 670.72 408.58 822.2 0 393.39 591.58 385.18 534.08 383.82 0.01 IR03559 OLS -0.02 -0.00 IR03560 OIS 0.00 673.28 407.08 606.91 426.56 614.21 404.13 6:18.66 396.99 430. 37 480.61 494.07 764.15 it 391.12 604.58 404.41 0.00 NOT ON STUDY 0.05 11 -0.02 0.04 :LJL :L :Li 1. 0 -0.03 ' -0.04 " :L:l 1 L:L :L:L 1. 0 11 1 1.:1 1 :L:L 1 :L:i 1 11 1 11 1 :L:L 1 e.ei -0.00 it 62:L. 94 399.26 646.43 407.5 -0.02 NOT ON 0.02 746.72 379.iS 673.7 402 0.04 NOT ON 0.03 759.2 402.2 767.95 STUDY STUDY 383.43 593.4 397.98 -0.03 NOT ON -0.06 -0.04 NOT ON -6.04 719.24 383.5 700.1.9 38:L.49 5:12.62 419.08 670.72 408.58 822.2 STUDY STUDY 393.39 591.58 385. :L8 534.08 383.82 0.01 NOT ON STUDY .-0.02 0 NOT ON STUDY 0 673.28 407.08 606.91 426.56 61.4.21 404. :L3 6LS.66 396.99 724 IR03565 015 FOODJRR LIS IR03566 ois FOODJAR IPO--1567 TA -@ODJAR iiS OIS its - .0-@-568 OIS PAT # FOODJAR IR03569 FOODJAR iRO3570 RAT # FOODJRR IR03571 FOODJAR iRO3572 FOODJAR IR03573 VTFI FOODJAR IR03574 FOODJAR iRO2575 PAT * IIS OIS IIS OIS IIS OIS liS OIS IIS OIS liS OIS IIS OiS FOODJAR IR03576 RAT # FOODJAR IR03577 FOODJAR IR03578 FOODJAR IR03579 FOODJAR IR03580 RAT # FOODJRR IRe3581 FOODJAR IR035S2 FOOD-JAR IR03583 FOODJAR iRO3584 RAT # FOODJAR IR03585 FOODJRR iRO3586 FOODJAR IR03587 FOODJFFR IR03588 RAT # FOODJRR "'03589 ..T * FOOD-JAR IR03590 F'.AT # FOODJAR IR03591 FOODJAR IR03592 LIS OiS IIS OIS 115 OIS ilS OIS IIS OIS 115 025 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 125 02S 12S 02S 12S e2S 704.74 N -@93.41 ' 549.93 ' 427.42 ' $41.7 0 377.26 -0.00 IR03568 OIS -0.02 720-58 364.35 -0.03 iRO3570 OIS -0.03 675.60 399.32 564.92 423.67 689.63 0 395.70 504.70 333.06 0.06 IR03575 OIS o.es , -0.02 ' IR03576 OIS -0.04 ' 676.23 ' 4e5.85 ' 629.35 ' 375.33 ' 621.63 ' 372.57 ' -0.06 iRO3580 OIS -0.06 71:1. 98 371.95 559.17 389-97 540.79 393.59 0.04 IR03584 02S -0.00 645.94 390.10 685.33 388.01 549.91 401.50 0.02 IR03588 02S 0.04 0.08 iRO3589 02S 0.00 0.09 IR03590 02S 0.04 ' 441.81 ' 373.69 ' 0. 14 ' 1 Li 1 0 11 1 -0.00 It 1. It 1 -0.03 It 1 0 11 1 11 1 0.06 11 1 -0.02 11 1 it 1 iIt 11 1 :L:l 2 1.2 2 :L2 2 12 2 :L2 2 :L2 2 :L2 2 12 2 :L2 2 :L2 2 :L2 2 12 2 -0.06 0.04 0.02 0.08 0.09 704.74 393.41 549-93 427.42 941.7 377.26 0 NOT ON -e.e2 720.58 364.35 -0.03 NOT ON -0.03 675.6 399.32 564.92 423.67 689.63 STUDY STUDY 395.7 504.7 333.06 0.06 NOT ON 0.08 -0.02 NOT ON -0.04 676.23 405.85 629.35 375.33 62:L.63 372.57 -LT 06 NOT ON -0.06 7:1:L.98 371.95 559.17 389.97 540.79 393.59 0.04 NOT ON 0 645.94 390.1 685.33 388.0:L 549.9:L 40:L. 5 .-0.02 NOT ON 0.04 0.08 NOT ON 0 rd.09 NOT ON 0.04 441.81 373.69 0.14 STUDY STUDY STUDY STUDY STUDY STUDY STUDY 725 F'FlT FOODJAP 125 IR03593 e2s TR FOODJRR 125 IRO--1594 02S 3DJRR iwea595 FOOD-JAR IR03596 FOODJRR IR03597 FUODJAP IR03598 RAT 0 FOODJAR IR03599 FOODJAR IR0360e FOODJAR IR03601 FOODJAR IR03602 FOODJAP IR03603 FQODJAR IR03604 RAT # FOODJRR iRO3605 FOODJRR iRO3606 FCODJAR iRO3607 FOODJRR iRO3608 FOODJAR TFI IR03609 FOODJAR IR036te 125 025 125 02S 12S 02S 12S 02S 125 02S 12S e2S 125 02S 12S 025 12S 025 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 125 025 125 e2S iRO@-592 02S a.rd9 1 552-22 ' 0 391-53 ' 381.81 " 560.58 ' 3!?0.62 " 752.35 ' 367.25 590.43 399.43 -0.07 iRO3598 02S -0.03 625.60 389-13 614.80 393.70 655.73 396.99 645.73 384.97 635.65 400.66 0.02 :LR03604 02S -0.03 ' 581.56 ' 386.23 ' 509.44 ' 419.19 ' 666.69 ' 374.53 ' 664.25 ' 389.36 ' a 580-95 ' :@97.12 ' 0. 14 12 2 0 12 2 :12 2 12 2 12 2 12 2 -0.07 12 2 12 2 :L2 2 12 2 12 2 :12 2 0.02.' 1.2 2 :12 2 12 2 :12 2 12 0 2 12 2 NOT ON 0.09 552.22 STUDY 391.53 679.96 381. ei 560.58 3-qO.82 753.35 367.25 590.43 399.43 -0.07 NOT ON -0.03 625.6 399.13 614.8 393.7 655.73 396.99 645.73 384.97 635.65 400.66 0.02 NOT ON -0.03 58:L.56 386.23 509.44 419.19 666.69 374.53 664.25 389.36 STUDY STUDY 580.95 397.12 710.42 FOODJAR 125 TR IR03611 e2S FOODJAR 12S IR036i2 02S FOODJRR 12S iRO3613 02S RAT FOODJRR 12S IR036i4 02S FOODJAR 12S IR03615 02S FOODJRR 12S 03616 02S mrit # FOODJAR 12S IR03617 02S PAT * FOODJAR 12S IR036le 02S TFI 385.20 ' 0 677.09 ' 373.99 ' 647.77 ' 398.05 ' -0.00 IR03613 02S -0.02 509.12 394.63 596.34 387.58 -e.02 IR03616 025 -0.02 -0.04 IR@3617 02S -0.02 ' 784.26 ' 0 12 0 2 12 2 12 2 :12 2 -:L2 2:L2 2 :L2 2 12 2 0 385.2 -e.se -0.02 ' -0.04 ' 677.09 373.99 647.77 398.05 0 NOT ON -0.02 --509.:L2 394.63 596-34 387.58 -0.02 NOT ON -0.02 -0.04 NOT ON -0.02 784.26 STUDY STUDY STUDY 726 FOODJAR 12S IR036i9 025 FOODJPR 12S IR0362o e2S RFIT 0 FOODJAR 12S IJZ 'L FOODJAR IR03622 FOODJAR 1R03623 FOODJAR 1R03624 FOODJAR 1R03625 FOODJAR 1R03626 FOODJAR 1R03627 FOODJAR IR03628 FOODJAR 1R03629 FOODJAR 1R03630 FOODJAR 1R03631 FOODJAR 1R03632 FOODJAR 1R03633 FOODJAR 1R03634 FOODJAR 1R03635 FOODJAR 1R03636 FOODJAR 1R03637 FOODJAR 1R03638 FOODJAR 1R03639 FOODJAR 1R03640 FOODJAR 1R03641 FOODJAR 1R03642 6-0-0&JFIR :L25 IR03643 02S RFIT # FOODJAR 12S IR03644 025 F-ODJRR 12S IR03645 025 FOODJAR 12S IR03646 03S FOODJAR 13S iRO3647 03S FOODJAR 13S IR03648 03S RAT # FOODJRR 13S 380-01 :L-@ 493-89 2 400-06 12 0.06 2 IR03620 025 0.04 12 0 0 486. 32 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 0. 01-7- 1-2 0.02 2 IR03643 02S 0.01 -12 566.77 2 387.09 12 645.49 2 365.14 12 619.92 3 4:10.55 13 583.07 3 386.25 13 0.12 3 IR03648 03S 0. 12 13 0.06 0.02 0.12 493.89 400.06 0.06 NOT ON 0.04 STUDY 4RA 'Z2 435.32 0.00 NOT 0.00 611.60 388.96 597.97 374.25 0.00 NOT 0.00 0.02 NOT 0.02 0.02 NOT 0.00 620.17 403.07 707.61 371.95 525.21 396.45 672.57 383.83 638.96 367.74 706.58 368.88 469.41 410.53 5.61.91 397.34 582.10 412.80 ON STUDY ON STUDY ON STUDY ON STUDY 621.49 392.85 0.00 NOT ON STUDY 0.03 509.69 416.85 0.05 NOT ON STUDY 0.12 596.15 391.95 0.03 NOT ON STUDY 0.01 0.02 NOT ON .-O.ol 566.77 387.09 645.49 365.14 619.92 410.55 583.07 386.25 0.12 NOT ON 0.12 STUDY STUDY 727 lpealt-149 OaS FO@--D-JAP :13S IR02650 03S FOOL)JAR i3S IR03651 03S FOOE)JAR 13S IR03652 03S FOODJAR i3S IR03653 eas FOOI@JAR 13S 1POL654 035 F-ODJRR@135 IP03655 03S FO-'DJAR 13S IR03656 03S FOODJAR@135 IP03657 03S PAT * FOODJAR 135 IP &658 03S FBODJAR 13S iRO3659 035 FOODJAR i3S IR03660 035 FOODJRR 13S IR03661 03S FOODJAR 13S IR03662 03S TFI FOODJAR 135 IR03663 03S FOODJAR 13S IP02664 03S FOODJRR 13S ""03665 03S .. T# FOODJAR 13S iRO3666 035 FOOD-JAR 13S IR03667 035 FOODJRR L35 IR03668 e3S FOODJRR i3S IR03669 03S PAT # FOODJAR 135 IR03670 03S TFI FOODJAR 13S tRe367L 03S DDJRR 13S iNO3672 03S FOODJRR 13S iRO3673 03S FOODJRR 13S IR03674 03S FOODJAR 135 TA IR03675 03S FOODJRR 135 IR03676 03S Tfi FOODJAR 13S IR02677 03S FOODJAR 135 IRO'@-678 035 67E.. 42 3 --@8:4. 9 C- I:, 577.01 3 385. 62 13 707.14 3 :176. 67 " 13 750.65 ' 3 385.75 ' 13 679.90 ' 3 362.25 ' 13 f@17.94 3 -@77.20 13 641.77 3 396. 57 13 679.44 3 398.16 13 0. 16 3 IR03657 03S 0.16 0.10 13 61l.94 3 405.47 13 731.83 3 375.15 13 737.30 '-Z Z,83.86 13 684.04 3 @@71.53 13 420.35 3 0 0 417.41 13 704.06 3 380.85 13 558.00 3 395.94 -e.oe IR03665 03S 13 3 -0.00 -0.01 13 675.72 3 38iE..90 13 546.54 3 404.96 13 544.Si 3 420.63 13 0.07 3 IR03669 035 e.07 0.09 " 13 738.29 ' 3 0 0 385.63 ' 13 645.31 ' 3 .388.07 ' 13 70rd.54 ' 3 386.48 ' 13 645.94 ' 3 395.87 ' :L3 790.32 ' -3 380.65 ' :L3 0 0 718.25 ' 3 340.10 ' 13 751.77 ' 3 0 0 366.54 ' 13 652.02 ' 3 406.85 ' 13 -0.01 E.7E..42 3Z,:44. 96 5-.77.01 --@85.62 707.14 378. 67 750.65 385.75 679.9 -@6:<.2 5 717.94 377.2 641.77 396.57 679.44 398.16 0.1.6 NOT ON 0.1 611.94 405.47 731.83 375.15 737.3 383.88 684.04 371.53 420.35 STUDY 417.41 704.06 380.85 558 395.94 0 NOT ON -e,ot 675.72 396.9 546.54 404.96 544.81 42e.63 0.07 NOT ON 0.09 739.29 STUDY STUDY 385.63 645.31 398.07 708.54 386.4e 645.94 395.87 -780.32 380.65 7:LB.25 340.1 751.77 366.54 652.02 406.85 -0.01 728 RAT FOODJAR 135 IR03679 03S TFI FOODJAR 13S IR03680 035 FOODJAR 13S IR03681 03S TR FOODJAR 13S iRO1662 03S FOODJAR 135 IRO!683 035 FOOD-JAR 135 IR03684 03S TA FOODJAR 135 IR02685 03S FOODJAR 13S IR03686 03S TFI FOODJAR 13S IR03687 035 FOODJAR 13S IR03688 035 FOODJRR 13S IR03689 03S FOODJRR i3S IR03690 035 FOODJAR 13S IR03691 035 FOODJAR 13S IR03692 03S FOODJAR 13S IR03693 03S ODJRR 13S ikO3694 03S FOODJAR 13S IR03695 03S FOODJAR 13S 9999999999 iRO3678 035 0.00 824.2 0 728.66 378.72 619.25 0 382.15 537.63 415.43 753.01 332.39 748.42 0 394.58 631.80 396.90 746.0 0 381.34 ' 686.71 ' 407.80 ' 726-06 ' 375.77 ' 489.85 409.39 637.16 391.94 586.51 398-90 520.88 424.70 ' 791.56 ' 362.26 ' 657.57 ' 377.65 ' 725.44 ' 383.46 99 -e.ei 13 3 a 13 3 13 3 0 :13 3 13 3 13 3 0 13 3 13 3 0 13 3 :13 3 13 3 13 3 13 3 13 3 1.3 3 13 3 13 3 13 0 NOT ON 0 824.2 STUE)Y 371.81 729.66 378.72 619.25 382.15 537.63 415.43 753.01 332.39 748.42 394.58 631.8 396.9 746 381.34 686.71 407.8 71@@,6.06 375.77 4eq.85 409.39 637.16 391.94 586.51 398.9 520.88 424.7 791.56 362.26 657.57 377.95 725.44 383.46 729 TW- YEAR ORRL(DIET> TOX-ONC STUHY OF FM-3924 & FC-143 IN RATS EXP.# 0281CROO12 TECHNICIAN INITIRLS:S SW TOI.'-RY@S DATE:S 9/21/82 SEX OF PATS:S MRLE ROOM NUMBER:S D-340,D-338 WEIGHT OF FULL FOOD JAR:S 550GRAMS WEEK 74 IP03516 RAT # FOOE)JAR IR03517 RAT # FOOHJRR tRea5le TA FOOHJAR IR03519 FOODJRR lROa520 RAT # FOODJAR IR03521 FOODJAR IR03522 RAT # FOODJAR IR03523 FOODJAR IR03524 FOODJRR IP02525 FOODJRR IR03526 FOOE)JAR IR03527 RAT # FDODJAR IR03528 FOODJAR IR03529 FOODJRR iRO3530 FOODJAR IR03531 FOODJAR IR03532 FOODJAR IP03533 @OODJRR @03534 TFi FOODJAR IR03535 PAT # FOODJRR IR03536 T Fi OiS ilS O:LS ilS eis IIS 015 IIS OIS IIS OIS IIS OIS liS OLS IIS OIS IIS OIS I"S OIS liS 015 IIS OLS IIS OIS IIS OIS IIS SIS LIS OIS IIS 015 LiS OiS liS OIS IIS 015 -0.12 IR035i6 OIS -0.09 -0.10 IR03517 OIS -0.13 608.33 0 401..75 688.io 402.57 -0.03 IR03520 OIS 0.00 500.59 428.14 -0.02 IR03522 OLS -0.01 74:1.e2 389.13 603.67 395.:L5 607.36 397.14 676.93 390.24 -0.02 IR03527 OiS 0.02 ' 789.47 ' 389.81 ' 745.45 ' 396.68 ' 648.63 ' 413.12 ' 675.33 ' 396.06 ' 646.16 ' 404.83 ' 705.10 ' 386.35 ' 788.73 ' 368.56 ' 0.06 IR03535 OIS 0.03 555.56 0 1 -0.12 11 1 -e.io It 1 0 11 1 it 1 11 1 11 1 :It -o.e3 -0.02 1 it 1 11 1 1 1 11 :1 -O.e2 11 1 11 1 11. 1 11 1 it 1 It 1li 1 a 11 1 0.06 11 1 0 -0.12 NOT ON -0.09 -0.1 NOT ON -0.13 608.33 STUDY STUDY 401.75 688.1 402.57 -0.03 NOT ON 0 5eO.59 428.14 -0.02 NOT ON -0.01 74:1.02 189.13 603.67 395.15 607.36 397.14 676.93 390.24 -e.02 NOT ON 0.02 789.47 389.Bi 745.45 396.68 648.63 413.12 675.33 396.06 .646.16 404.83 705.1 386.35 788.73 STUDY STUDY STUDY 368.56 0.06 NOT ON 0.03 555.56 STUDY 730 FOOC)JRR IR03537 RAT # FOODJAR IR03538 FOODJAR IR03539 )ODJFIR IR03540 RAT # FOOEJJAR IR03541 FOOE)JAR IR03542 FOODJHR IR03543 RAT # FOODJAR IR03544 FOODJRR IR03545 FOODJRR IROZ546 PAT # FOODJRR 115 OiS IIS OIS liS OIS IIS OIS IIS OIS 115 OIS IIS OIS liS OIS IIS OIS liS OIS IIS 424.79 ' -0-05 ' JR03527 OIS -0-07 ' 765.01 382.09 606-14 411.67 -0.00 IR02540 OIS 0. 00 627.45 394.38 648.24 396.10 -0.03 iRO3543 OIS -0.03 753.81 364.44 660.97 401.89 -O.OL:t IR03546 OiS -ri.09 I 11 1 -0-05 11 1 -e.ee -0.03 -0.08 11 424.79 -0.05 NOT ON -0.07 765.01 383-09 606.14 411.67 0 NOT ON 0 627.45 394.38 648.24 396.1 -0.03 NOT ON -0.03 753.81 364.44 660.97 401.89 -0.08 NOT ON -0.09 STUDY STUDY STUDY STUDY IR03547 015 T Fi FOODJAR IIS IR03548 OIS FOODJRR IIS IR03549 FOODJAR OIS liS IR03550 OiS RAT # FOODJAR IIS IR03551 OIS RAT # FOODJRR 115 IR03552 OiS FOODJAR IIS IR03553 OiS FOODJAR IIS IR03554 FOODJAR IR03555 OIS itS OIS FOODJAR IIS IR03556 OIS TA FOODJAR IR03557 IIS OIS FOODJAR LIS IR03558 OIS FOODJAR liS IR03559 OiS RAT # FNDDJAR IIS )3560 O:Ls RAT # 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O:L IR03560 OIS 0.03 683.07 367.6r6 612.02 394.25 621.12 :1 0 :li :1 :Li 1 :Ll -0.02 0.02 li 1 0 11 1 11 1 I:L -1 11 1 li 1 :Li 1 11 1 -0.00 -e.oi 743.6 3199. 21 758.0:1 386.54 596.95 401..2 -0.02 NOT ON -er.03 0.02 NOT ON -e.ei 713.42 385.61 699.5:L 381..02 5:L4. :L5 420.24 672.:L5 395.79 9:15.6 STUDY STUDY 387.93 595.32 391.21 524.89 ..400.52 0 NOT ON 0 -0. O:L NOT ON 0.03 683.ID7 367.6 612.e2 394.25 621.12 STUDY STUDY 731 FOOC.,.JAF'. 1.:LS IR03564 015 FOODJRR 115 IR03565 015 FOODJRP IP@3566 FR,QDJRP liS eis ilS - j3567 OIS TFl FOCI[.-JFIP. 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O:L 518.30 318.75 -0. 1.1 J.R03575 OIS -0.09 -0.10 IR03576 OIS -e.ii 668.27 398.45 627.77 377.02 626.27 364.67 -0.12 IR03580 015 -0.13 703.85 374.26 556.99 385.37 531.75 396.37 -e.oe IR03584 02S -0.08 640.28 385.47 672.38 391.50 549.27 395.59 -0.12 iRO35se e2S -0.07 -0.10 iRO3589 02S -0.07 -0.07 IR03590 02S -0.09 451.48 11 :Li 1 0 li :L -0.05 i.:l 1 :Ll 1 -0.03 11 :1 :Li 1 :L:L 1 :1:1 1 11 1 -0.11 li 1 --@0.10 11 1 11 1 :li 1 11 1 -0.12 11 2 12 2 12 2 12 2 -0.08 12 2 12 2 12 2 1.2 2- -0.12 12 2 -0.10 12 2 -0.07 12 2 405. 78 621.56 394.05 70C1.56 393-95 544.72 429.27 839. 3 372.74 -0.05 NOT ON STUDY -0.03 723.98 365.64 -0.03 NOT ON STUDY -0. :1 671. :L2 399.32 574.09 336.75 689.34 382.01 518.3 3:L8.75 -e.ii NOT ON STUDY -0.09 -0.1 NOT ON STUDY -0.11 668.27 398.45 627.77 377.02 9.16.27 364.67 -0.:12 NOT ON STUDY -0.13 703.85 374@26 556.99 385.37 531.75 396.37 -0.08 NOT ON STUDY -0.08 640.28 385.47 672.38 391.5 .-549.27 395.59 -0-12 NOT ON STUDY -0.07 -e.i NOT ON STUDY -0.07 -0.07 NOT ON STUDY -0-09 451.48 732 FOOE,JRR 125 IP03592 02S R.FIT # FOODJRR 125 iRO3593 02S FOOE:-JAR 12S 1RO3594 02S )0[)JAR:L2S IRO@-595 02S FOODJAR 12S IR@3596 02S FOODJAF' i2S IR03597 e2S FOODJAR 12S IR035ge e2s RAT # FOODJRR IR03599 FOODJAR iRO3600 125 02S 12S 025. FOODJAR 12S IR03601 e2S FOODJRR 125 IR03602 02S FOODJAR 12S IR02603 025 FOOE@JAR 12S IF:03604 025 RAT # FOOE)JRR 12S iRO3605 02S FOODJRR 12S IR03606 e2S FOODJAR 12S IR03607 02S FOODJAR 12S IROZSOS 02S FOODJAR 12S lROl6O9.e2S Foo[,JAR 12S IR036le 025 TFI FOODJAR 12S *A IR03611 02S FOODJAR 12S IR03612 025 FOODJAR 12S IR036i3 02S RAT # FOODJRR 12S IR03614 FOODJAR iRO3615 02S :L2S e2S FOODJRR 125 iRe3616 02S RAT # FOODJAR 12S 13617 02S PHT # FOODJAR 12S IR036i8 e2S FOODJAR 12S iRO3619 02S FOODJRR 12S lRe3620 02S 69 0.05 IR03592 025 0.06 546.99 365.07 679.23 363. 23 552. 61--o 395.24 746.31 376. 76 592.:12 397. 5r:s -e.e6 IR0359e 025 -e.ee 620.17 380.77 473.76 544.50 660.26 390.22 649.33 378.89 620.89 396.77 0.16 IR03604 02S 0.24 ' 571.46 e 393.26 ' 509.42 ' 422.35 ' 659.64 ' 379.61 ' 647.43 ' 385.01 ' 575.37 e 385.72 ' 707.95 ' 0 373.17 ' 0 673.90 ' 379.41 ' 647.55 ' 383.00 ' 0.02 e IR03613 e2S -0.01 499.24 396.42 587.82 379.51 0.01 IR03616 02S e.ei -e.02 IR03617 02S 0.03 777.93 371.e5 495.71 394.13 0.02 2 e.o5 12 2 12 2 12 2 :12 2 :L2 2 :L2 2 -0.06 12 2 12 2 12 2 12 2 12 2 12 2 0.16 12 2 12 2 12 2 12 2 12 2 1.2 2 0 12 0 2 12 2 12 2 O.e2 12 2 12 2 12 2e.ei 12 2 -0.02 12 2 12 2 12 2 381. 69 0.05 NOT ON STUDY 0.06 54L;.99 365.e7 679.23 363.23 552.69 395.24 746.31 376.76 592.:12 397.59 -0.06 NOT ON -0.08 620.17 STUDY 38e.77 473.76 544.5 660.26 390.22 649.33 378.89 620.89 396.77 0.16 NOT ON STUDY 0.24 571.46 393.26 509.42 422.35 659.64 Z79.61 647.43 385.01 575.37 385.72 707.95 373.17 673.9 379.41 647.55 383 O.e2 NOT ON -0.01 499.24 396.42 587.82 -379.51 0.01 NOT ON 0.01 -0.02 NOT ON O.e3 777.93 371.85 495.71 394.13 e.02 STUDY STUDY STUDY 733 PAT 0 FOOC).JAP ipo362i FOC#DJAR IRO!622 RAT * :12-q 02S 12S 02S Fn'IDJAR i2S -- 1:,.62202S T Fi FOODJAF* 125 IR02624 02S FOODJAR 125 IPOI-:625 02S RAT # FOODJAR 12S IR03626 02S PAT # FQODJAR 12S IRO--@:627 025 PAT # - FOODJAR 12S IR03628 02S FOODJAR 12S T Fi IR03629 02S FOODJRR 12S iPO3630 02S FOODJAR 12S IR03631 025 TR FOODJAR 12S IR03632 02S FOODJAR 12S IR03633 025 FOOHJRR 12S IR03634 02S FOODJRR 12S iPO3635 02S FOODJRR 12S IR03636 02S FOODJAR 125 IP03637 02S FOODJAR 125 IR03638 02S RAT # FOODJAR 12S iRO3639 02S FOODJAR 12S IR03640 02S RAT # FOODJRR 12S iRO3641 02S FOODJAR 12S IR03642 02S RAT # FOODJRR 12S iRO3643 02S DRIT * JODJAP 12S IR03644 02S FOODJAR 12S IRO!645 e2S FOODJRR 12S IR03646 03S FOODJAR 13S IR 3,47 03S IR03620 025 0.00 487.83 415.90 0.02 IR03622 02S 0.03 599.:16 ci :191.to 601--l.61 368.20 -0.11 lr<03625 02S. -0.12 -e.io IR03626 02S -0.11 -0.13 iRO3627 02S -0.12 ' 612.46 ' 405.95 ' 0 703.90 ' 366.53 " 517.59 ' 396.55 ' 660.44 ' 0 384.86 ' 633.01 ' 375.43 ' 697.77 ' 374.13 ' 470.62 ' 390.96 ' 554.01 ' 401.88 ' 567.63 ' @@ 398.53 ' 613.01 ' 386.52 ' -0.04 ' IR03638 025 -0.02 ' 532.06 ' 382.55 ' 0.08 IR03640 02S 0.02 594.14 395.16 o.es iRO3642 02S 0.04 ' 0.05 e IR03643 025 -e.ee 569-06 395.01 635.07 3se.67 620.58 400.96 597.86 0.02 NOT ON STUDY 12 0 2 487.83 12 415.9 2 0.02 0.02 NOT ON STUDY 12 0.03 2 599.16 0 12 391.1 2 602. 61 12 368.2 2 -0.11 -0.11 NOT ON STUDY 12 -0.12 2 -e.i -e.io NOT ON STUDY 12 -0.11 2 -0.13 -0.13 NOT ON STUDY 12 -0.12 2 612.46 12 405.95 0 2 703.9 12 366.53 2 517.59 12 396.55 2 660.44 0 12 384.86 2 633.01 L2 375.43 2 697.77 12 374.13 2 470.62 12 390.96 2 554.01 12 401.88 2 567.63 12 398.53 2 613.01 12 386.52 2 -0.04 -0.04 NOT ON STUDY 12 -0.02 2 532.06 12 2 0.08 382.55 e.ee NOT ON STUDY 12 0.02 2 594.14 12 395.16 2 0.08 - 0.08 - NOT ON STUDY 12 0.04 2 0.05 0.05 ' NOT ON STUDY 12 0 2 569.06 12 395.01 2 635.07 12 380.67 3 620.58 13 400.96 3 597.86 734 FOOE)JAR 135 IR03646 03S RAT # FOODJAP J35 1RO3649 035 FOODJRR 13S IF*03650 035 )ODJRP. 135 IRO-@,651 035 F-OD-JRR 13S lRoi65L 02S TFI FOOE)JAR 135 IR03653 03S FOODJAR 13S IR03654 03S FOODJAR 13S IR03655 035 FOODJAR i3S IR 3,56 03S TF1 FUODJAR 13S IR03657@035, Tt r ODJAR 13& 1R03658 FOODJAR 13S IR03659 e3S FOODJRR 13S IR03660 03S FOODJAR 13S IR03661 03S FCODJAR 13S IR03662 03S FOODJAR 13S IR03663 03S TFI FOODJAR 13S IR03664 03S FOODJRR 135 IR03665 035 RAT # FOODJRR 13S iRO2666 03S FOODJAR 13S IR03667 03S FOODJAR 13S IR03668 03S FOODJAR 13S IR03669 03S RAT # FODDJAR 13S iRO3670 03S FOODJAR 13S IR03671 03S FOODJAR 13S IR03672 03S FOODJAR i3S IRO1673 03S ! 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IR03640 02S FOODJAP 12S TA iRO3641 02S FOODJAR 12S iRO3642 02S 0. e5 ' 0 599.76 ' 387.74 ' 0.09 RAT # IR03642 02S FOODJRR 12S IR03643 025 0.06 0.08 RAT # FOOD-JAR 12S IR03643 02S 0.06 TFI IR03644 02S FOODJRR 12S 0 547.24 388.1.6 TA IR03645 02S FOODJAR 12S 0 643.34 391.47 iiRO3646 03S FOODJAP 13S IR03647 03S TFi FOOE)JAR 135 iRO3648 03S F'.FIT# FOODJRR i3S IR03649 03S FOODJAR 13S TFI IR03650 03S FOODJAR 135 IR03651 03S FOODJRR 13S IR03652 03S FOODJAR 13S TA IR03653 03S FOODJRR 13S IR03654 03S FOODJAR 13S TR IP03655 03S 1 )DJFIP13S TFI IR03656 03S FOODJAR 13S IR03657 03S PAT # FCIOD.;AR 13S IR03658 03S 382.75 558.:LO 0 459.53 0.00 IR03648 03S -0.03 682.23 377.1 0 588.70 390.85 700-71 399.87 74:L.:19 374.1 0 670.83 366.77 71.6.73 ' 363.2 ' 0 653.70 ' 376.7 ' 0 678.46 ' 372.84 ' -0.03 IR03657 03S 0.01 609.62 12 2 12 2 12 2 0 12 2 12 2 :12 2 12 2 :12 0 2 12 2 :L2 2 :L2 0 2 :L2 0 2 :L2 2 :13 3 0 13 3 13 3 :L3 a 3 13 3 :L3 3 :L3 a 3 13 -3 1.3 9 3 :L3 0 3 L3 3 13 3 0.02 0.00 0.09 0.08 0.00 -0.03 369.76 460.69 404.46 569.82 396.65 580.5 387.34 616.94 371.68 0.02 NOT ON 0 522.69 398.08 0 NOT ON 0.05 STUDY STUDY 599.76 387.74 0.09 NOT ON 0.06 0.08 NOT ON 0.06 STUDY STUDY 547.24 388.16 643.34 391..47 636.26 482.75 558.:l 459.53 0 NOT ON -0.03 682.23 377.1 STUDY 589.7 390.85 700.71 399.87 74:L.19 374.1. 670.83 366.77 7:L6.73 363.2 653.7 376.7 678.46 372.84 -0.03 NOT ON 0.01 609.62 STUDY .742 FOOE).JFIP 135 IR03659 03S FOODJRR 13S IR03660 03S FOODJAR 13S iRO3661 03S Fr,O[)JAR13S @. -o36E.2 OZS FOOEJJAR I'S IR03663 035 FOOE)JAR 13S IR03664 035 FOODJAR 13S iRO3665 035 RAT # 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C40 IR03520 OIS -0.00 522.25 369.36 -0.04 IR03522 OIS -0.04 ' 764.72 ' 36e.09 610.46 409.19 624.13 --r75.74 705. 2:1 Z77. 46 0.02 IR03527 015 0.01 :905. 02 -0.05 -0.05 ' NOT ON STUDY :11 -0.01 1 0.02 0.02 ' NOT ON STUDY It 0.02 633.95 :11 396.16 1 667.84 11 376.65 1 -0.00 11 1 11 1 -0.04 It 1 11 1 11 1 it 1 :Li 1 0.02 11 1 11. 0 NOT ON 0 522.25 369.36 -0.04 NOT ON -0.04 764.72 368.09 610.46 409.19 624.13 375.74 705.23 :177. 46 0.02 NOT ON 0.01 805.22 371. 5 STUDY STUDY STUDY IIR@2529 FOODJAR IR@3530 FOODJAR IR03531 FOODJAR IR03532 FOODJAR IRO3531FOODJRR IRO---534 Ol.S ilS OLS IIS OIS LIS OIS LIS eis LIS OLS T-UODJRP 115 1poi535 eis F,fiT# FOODJAR IIS IRO-@536 OIS FOODJAR IIS IPO!537 OiS 762.88 2.71.51 624.02 402.94 702.02 388.801, 666.48 ' 397.96 ' 741.05 ' 382.35 ' 826.4 ' e 349.61 ' -0.04 ' IR03535 OIS -0.05 " 571.73 @ 416.00 ' 0.01 1 :Li 1 It 1 11 1 11 1 It 1 0 It 1 -0.04 11 1 11 1 762.88 @@71. 5:L 624.02 402.94 702.02 388.8 666.48 Z97.96 '741.05 382.35 $26.4 349.61 -0.04 NOT ON -0.05 571.73 416 0.01 STUDY 766 PAT FOUE@JRP FOODJAR 115 eis :L:Ls -0. 02 786. 9E; 0.01 11 :1 11 NOT 014 STUDY 98 378.79 .QDJRR lis IF*C'3540 015 PAT # FL--IUDJAP lPOa541 FOODJRR IR03542 FOODJAR IR03543 PAT # FOODJAR IR03544 FOODJAR IR03545 FOODJAP IR03546 PAT # FOOE)JAP IR03547 TFI FOOE)JAR IR07-548 TA FOODJRR IR02549 FOODJAR IR03550 PAT # 115 GIS iiS 015 IIS OIS liS 015 IIS OiS' 115 OIS 115 015 IIS OLS IIS OIS 115 OIS FOODJAR iRO2551 PAT FOODJRR IR02552 FOODJRR IR02553 FOODJAR IR02554 FOQDJRR IROZ555 FOODJRR IR03556 TA FOODJFIR IR03557 FOODJAR IR03558 FOODJFKR IR03559 PAT * FOODJF#R IROZ560 iT FOODJAR IR03561 FUOEAJRR IR@3562 FOODJAR iRO3563 FOODJAR IIS eis IIS 015 115 eis IIS OIS itS OIS IIS ots ILS SIS I-tS SIS IIS Ol.S IIS eis IIS OIS IIS OIS IIS OIS II.S 20 S. 6 7 0. 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O:L IR03559 OLS 0. 03 0.06 IR03560 OIS -0.01 702.16 344.82 628.50 387.08 617.48 376.50 1 :Ll 1 :Ll 1 11 1 11 1 11 1 li :L 0 11 1 a 11 1 11 1 11 1 0 :Ll 1 11 1 1 11 1 :L:L 0.06 0.03 0.06 0.09 0.07 0.01 0.06 C-26.2 :188.67 0.06 NOT ON 0. e3 655.72 378.79 670.74 397.93 0.03 NOT ON 0 770.13 36:L. 6 647.54 398.31 0.06 NOT ON 0.03 602.22 STUDY STUDY STUDY 520.67 813.9. 353.54 504.71 437.85 0.09 NOT ON 0.06 0.07 NOT ON 0.05 725.94 376.86 710.76 370.19 524.27 407.53 703.7 390.56 849.4 STUDY STUDY 371.06 596.16 397.76 526.82 401.39 0.01 -.NOT ON 0.03 0.06 NOT ON -0.01 702.16 344.82 62rd. 5 387.08 617.48 376.5 STUDY STUDY 767 PAT FOODJAR IIS IR03566 ais FOOD irre.iis ,C,--,567OIS FOCE)JAF, RRT FOODJAR IR02569 FOODJAR IR02570 reFIT # FOODJAR IROS571 FOODJRR IR02572 FOODJAR IR03573 FOODJRP IIS ois iis 015 I:LS OIS IIS OIS IIS OIS' IIS OIS liS 01 eis 0. 5,E.I.IS 412.03 79E.. 85 -48. I'D ei.00 IR0356S eis -0. 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O:L STUDY STUDY STUDY 712.66 370.67 IR03582 02S FOODJAR 12S IR03583 02S FOODJAR 12S iRO3584 02S RFIT # FOODJAR 12S IR03585 02S FOQDJAR 12S 1R03586 FOODJRP 12S OZ587 02S T-OODJAR 12S IR03588 02S PAT # FOODJRR 12S 64Xa589 02S PAT 0 FOODJM 12S 570.47 385.89 580.65 382.95 0.04 IR035e4 02S 0.07 ' 655.84 ' 374.68 ' 576.42 ' 392.31 ' -0.04 IR03588 02S -0.04 -0.01 64X3589 92S .0.03 2 12 2 12 2 :L2 2 -12 1 2 12 2 12 2 12 2 12 0.04 -0.04 -0.01 570.47 385.89 580.65 382.95 0.04 NOT ON 0.07 .-.655.84 391.22 STUDY 694.03 274.68 576.42 392.31 -0-04 NOT ON -0.04 -0-01 NOT ON 0.03 STUDY STUDY 768 lRois9o 01-IS FOCIE)JAR i2S 0. 03 IR02591 025 455.8:1 ' 2 FOQDJAR 125 8 1E..7 c- ' 12 ikO'-@592 02S 0.05 2 .17 # IRO'!-:59202S I JOEAJRP 12S 0.02 12 IRO'-7593 02S 5--l-4.96 2 FUODJRP l@-'S 15 12 IR02594 025 705.24 " 2 FOOL-JRP 12S :,@55.44 " 12 IR03595 02S 571.35 ' 2 FOODJAR 12S 72 ' 12 iRO1596 e2S 782.L:kO ' 2 FOODJAR 12S 12 0.05 IR03597 FOODJAR IR03598 PAT # FOODJAR IROZ599 FOODJRR IR01600 FOODJRR IR03601 FOODJAR iRO3602 FOODJAR lROa6O3 FOODJRR IR03604 RAT # FOODJAR IRO'-605 FUODJRR iRei6o6 F*OODJRR IR03607 FOODJAR IR03608 FOODJRR IRO!609 FOODJRR IR03610 FOODJRR IR03611 FOODJRR IR03612 FOODJAR IR0361.3 RAT * FOUDJRR IR03614 FOODJAR 4RO3615 )ODJAR IR03616 PAT # FOODJRR IR026i7 PRT FOODJRR IR03618 02S 12S 025' 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 125 02S 12S e2S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 12S 02S 125 O'&@ S 12S 02S C,04.56 ' 395.38 0.00 lRoi-:598 02S -0.03 636. 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NOT ON -0.07 -0.09 NOT ON -0.07 6is.51 405. :LS 713.56 369.02 485.76 454. 5:L 689.06 STUDY STUDY STUDY STUDY STUDY 384.Si 644.51 365.97 IR03613 025 FOODJAR 12S IR03634 025 FOODJRR 12S IR03635 02S FOODJRR 12S IRO!636 02S TFI FOODJRR 12S IR01637 02S FOODJAR 12S IR03638 02S RAT # FOODJAR 12S IR03639 02S FOODJAR 12S IR03640 02S RAT # FOODJRR 12S 03641 02S irl FODDJAR 12S IP02642 02S RAT # FOODJRR 12S iRO3643 02S RAT 682.52 361.15 477.el 404.49 593.81 392.95 510.58 0 400.06 616.64 398.57 ' -0.03 ' IR03638 02S -0.25,' 569.61 @ 364.33 ' -0.14 ' IR03640 02S -0.08 603.48 0 379.89 0.04 IR03642 02S 0.02 -0.02 IR03643 02S 2 12 2 12 2 12 2 0 12 2 12 2 12 2 12 -2 12 2 0 12 2 :L2 2 -0.03 -O.:L4 0.04 -0-02 682.52 361.15 477.81 404.49 593.81 392.95 510.58 400.06 616.64 398.57 -0.03 NOT ON -0.25 569.6:L 364.33 ---0.J.4 NOT ON -0.08 603.48 STUDY STUDY 379.89 0.04 NOT ON 0.0411.1 -0.02 NOT ON STUDY STUDY 770 FC,O[A.JAP 12S IPO-I644 02S FOODJRP 12S IRG-7.645 025 FOOE,JRR.' 12S IPC,164--- OZS 'OL).JFIF*13S 0'--P7-4-7% 03S FOOE:-JfiF,* 13S IF.*01_:648 01-5 r-A.'T. # F OOCAJRF' i3S IPOI"--.49 01-S FOODJRR IZS IR03650 03S FOODJRR 13S IR03651 03S FOODJAR 135 :IR03652 03S. 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I =1. 24 t594. 15 :@5LA. 78 718. 69 164. 2s-@ 84:) APPENDIX ITEM F GROUP MEAN BODY WEIGHTS, INDIVIDUAL BODY WEIGHTS AND FEED JAR WEIGHTS OF FEMALE RATS RECEIVING FLUOROCHEMICAL FC-143 IN DIET FOR TWO YEARS NOTES: Code 1 indicatesa controlgroup rat weight Code 2 indicatesa FC-143 - 300 ppm group rat weight Code 3 indicatesa FC-143 - 30 ppm group rat weight Codes 11, 12, 13 indicatesthe total feed jar weightfor the previousrat(s) All weights are in grams 846 APPENDIX ITEM P Two Year Oral (Diet) Toxicit@r - Oncogenicity of Fluorocarbon FC-143 in Rats Study Group Mean Body Weights (g) + Standard Deviation Femal*s Study Week 0 2 4 6 a 10 12 14 16 is 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Control - 0 ppm Mean BW + SD (N) 300 ppm Mean BW + SD (N) 30 ppm Nean BW + SD (N) 138.2 + 159.2 209.5 238.7 256.9 + 269.2 279.5 289.7 + 291.8 + 306.8 + 311.6 + 319.1 324.5 + 327.3 333. 7 + 338.3 345.5 350.7 355.5 359.3 + 363.2 371.2 380.1 385.7 + 392.3 7 398.6 + 406.1 '7 10.7 10.1 14.8 17.6 20.3 22.0 23.6 29.7 27.4 28.3 29.1 30.7 31.9 33.0 33.2 33.6 36.6 38.0 38.1 40.8 40.9 42.1 45.7 47.4 51.1 53.6 53.5 (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (64) (64) (6,6) (64) (64) (64) (64) (63) (63) (63) (63) (63) (63) (62) 138.1 + -167.3 213.8 237.4 254.6 + 263.3 274.2 286.4 + 285.4 + 299.4 + 307.6 314.6 322.5 326.0 331. 6 338.6 344.1 352.8 357.1 362.3 + 366.0 373.2 + 380.4 385.9 + 391.67 399.3 + 406.1 7 9.6 10.0 14.1 15.9 18.9 20.2 20.8 23.0 25.3 27.1 29.4 30.9 33.3 34.1 35.3 30.1 39.9 42.9 45.0 46.2 48.4 49.7 52.4 53.1 55.5 56.5 58.8 (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (64) (64) (64) 137.2 + -166.0 214.9 235.7 253.8 + 261.3 275.5 282.8 + 285.9 + 298.0 + 304.1 309.9 318.6 323.6 330.4 339.0 + 344.9 353.5 358.0 + 363.1 + 367.5 ; 375.9 + 382.0 -; 389.7 + 395.8 399.7 + 406.2 10.4 10.2 13.9 17.9 19.8 20.8 23.2 25.9 25.6 27.2 30.6 32.3 34.2 35.8 38.1 40.5 42.1 44.9 46.3 49.8 54.4 54.6 56.2 58.8 63.1 63.5 63.8 (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (49) (49) (49) (48) (47) (47) l@Number of animals weighed Significant difference from Control at the 5% level (Dunnett's t Toot; a 0.05) 847 APPENDIX ITEM F Two Year Oral (Dist) Toxicity - Oncogenicity Study of Fluorocarbon FC-143 in Rats Group Mean Body Weights (g) + Standard Deviation Females Study Week 54 56 58 60 62 64 66 68 70 72 74 76 78 so 82 84 86 es 90 92 94 96 98 100 102 104 Control 0 ppm Mean BW + SD (N) 300 ppm Mean BW + SD (N) 414.1 + 419.1 420.9 423.6 426.6 426.1 424.9 + 427.5 431.4 435.2 446.5 455.2 464.8 + 474.9 484.0 484.8 492.7 499.1 500.6 + 512.5 505.7 506.9 500.0 501.2 503.6 502.0 + 46.9 45.0 46.6 45.6 46.4 43.8 48.7 49.6 50.6 55.0 62.0 76.3 65.6 69.2 65.1 67.2 71.0 70.3 71.9 71.4 76.9 79.6 78.3 71.3 69.6 75.0 (47) (46) (46) (46) (45) (43) (43) (43) (43) (43) (42) (42) (40) (39) (38) (37) (36) (35) (34) (34) (32) (31) (30) (26) (25) (25) 411.5 + 421.2 426.4 427.0 431.9 434.0 435.5 433.0 429.1 432.8 444.6 447.4 452.7 457.0 461.8 457.6 456.2 456.6 451.8 + -455.9 *451.0 464.5 468.0 464.2 462.8 450.3 60.7 63.1 64.6 65.7 65.9 68.9 70.2 72.6 73.9 75.5 72.5 66.6 66.8 68.9 64.0 62,,3 69.6 73.2 76.7 76.7 73.0 67.2 71.3 78.2 84.4 85.5 (49) (49) (48) (48) (47) (47) (47) (47) (47) (47) (46) (45) (44) (43) (42) (42) (42) (39) (39) (38) (36) (34) (33) (32) (31) (29) 30 ppm Mean BW + SD (N) 412.6 420.7 427.3 430.0 435.7 439.9 446.5 445.3 443.5 448.6 463.3 468.8 471.3 475.8 485.7 476.3 479.7 483.4 485.2 486.3 492.0 504.3 505.5 505.6 503.3 501.8 + 67.1 68.2 68.9 71.2 72.8 -+ 74.1 -+ 76.8 -+ 75.4 78.6 75.5 72.8 73.6 76.3 79.7 81.9 80.8 83.8 90.1 + 95.5 + 104.8 101.9 98.4 100.5 86.7 87.0 86.8 (47) (47) (47) (47) (47) (47) (47) (47) (47) (46) (45) (45) (45) (45) (43) (40) (40) (39) (38) (38) (35) (31) (28) (25) (24) (24) Number of animls weighed Significant difference from Control at the 5% level (Dunnott's t Test; a 0.05) 848 T14Ci YEFIF: CIF*.FIL@E)IET,-TCI,-@1-014CSTUDY OF TECHNICIR14 INITIALS:S MH TODAY -S LVATE: S SEX OF RATS S FEM@LE ROOM NUMBEF::'S D-340,C'-:138 WEIGHT OF FULL FOOD JRR:S S. 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OIS its eis OIS !IS 015 ots Its OIS OiS Its OiS eis its eis 015 115 OIS OIS its OiS eis its OIS OIS LIS OIS OIS Its OIS OIS Its OIS OIS Its OIS OIS Its -0.02 IP0457--c'OIS 4e!-. 6E. 47:1. 1.3 -o_.eo IP0451-e OIS 445.91 4 ---'4 -0.04 IP045eO OIS 4'f-O7.2 5n@S. 9:1 -0.00 IR045e2 OIS 45!-.9e 496.45 4:LC-4t:.L 0.00 IR04585 OIS 409. 1 --,.-' 287.66 462.38 348.65 0.00 iRO4588 OIS -0.0- IP04599 015 0.00 0. 11 IR04590 OIS 392. 4:L T-05. 01!. 3 7 r-t.0 A384.?5 457.82 390.73 354.28 0 480.85 44-L6.St ' 354.65 ' 407.35 -?1.5. ZE-7. 03 4C-5.51 0.12 ' IR04601 OIS 47f---.6i' '390.85 293.10 254.05 1 iIt :1 1 11 1 1 :L:L 1 :L It :1 1 It 1 1 11 1 1 It 1 :L 11. 1 1 11 1 1 11 0 1 t it 1 1 11 1 1 11 1 1 It -0.03 NOT ON STUDY 4e.5. 66 47:L. :L3 0 NOT ON STUDY 445.91 4 34 -0.04 NOT ON STUDY 40-@0.72 15001S.:L 0 NOT ON STUDY 455.98 496.45 410.41 0 NOT ON STUDY 409.:12 387.66 462.2e 348.65 0 NOT ON -C.e2 STUDY NOT ON STUDY El 0.1.1 NOT ON STUDY :92.41 505.05 472.50 378.08 3e4.90-; 457.82 290.73 354.28 480.85 .426.91 254.6m-@ 407.35 315.22 367.03 465.51 0.12 NOT ON STUDY 476.61 390.L:t5 293.1 :?54. ea-i 1054 IR04604 CIS ?5 ' 1 IR04605 015 --4e3. 49 ' i FOODIAR liS -tE.0S5. 11 T Fi 0 0 T Fl El 0 IP04606 OLS 445.04 1 IR04607 015 -0-02 1 4T # IR04607 015 FOODIRP ilS 499. 3e ' ii !P0460$ OIS co 0.04 ' 1. PAT # IP0460e OIS IP IP04609 OIS 2-93.4C,@ 1 FOOE, JAR IIS 495. 96 ' it iF!046iO OIS -0-03 1 PAT # IR04610 OIS IP04611 OiS 481.03 1 FOODJAR IIS 490. eL;t 1-1 IP04612 OIS 279.38 1 iPO46i3 OIS 454.39 1 FOODJAP IIS 37L:t.39 :11 IP046i4 OiS 422.32 1 IR04615 OiS 422.84 1 FOODJAP IIS 383.01 :Ll IP04616 @IS 367-27 1 IP04617 OIS 374.23 1 FOODIAP IIS 414.62 it IP046le OIS 401-.82 1 IP04619 OIS 374.65 1 FOODIAP IIS 285. !.6 11 iPO4620 CIS -e.ei 1 PAT # IR04620 OIS IP@462i OIS 369.0-;3 ' 1 FOODIAR iiS 492.42 ' 11 IR04622 OiS 463.1'-; ' 1 iPO4623 OiS 421.94 ' 1 FOODIAR !IS 341. 6-i4 ' 11 IP04624 OIS iPO4625 @IS 39$-;.79' 1 3eC4.Lq4 ' FOODJAP IIS 1R04626 iP@4627 OiS 477.34 ' FOODJAR 115 :?':-'573. ' 11 iPO4628 OIS 431.52 ' 1 IP04629 OIS -0.01 1 PAT # IP04629 OIS FQODJAP IIS 501.96 11 IP049---?C OIS 0.06 1 PAT # iRO4630 @IS IP04631 OIS 0.00 1 PAT # IR0462i OIS FOODJAR IIS IR04632 eis -0.00 11 -0-00 1 RAT # IR04632 OIS, IR04633 OIS 4P-2.12 ' I FOODJAR IIS 507.84 ' it IP04634 OIS 32C-.19 ' IP04635 CIS 463.52 ' FOODIAP itS 3w-@8.C-R- 1 IP04636 OIS 412.47 : )4637 OIS 355.12 1 FOOD-JAR IIS 298.85 11 IR04639 OIS 495.36 1 IP04639 OIS 0.01 1 PAT # IP04639 OIS FOODIAP IIS 367-41 ' 11 iPO4640 OIS -e.03 ' 1 RAT IP04640 OIS 426.95 24:-r.49 :.69.05 44-@%.04 -0.02 NOT ON 499.3Lq 0.04 NOT ON 393.48 495.96 -L3.03 NOT ON 4ei.03 490. 88 379.38 454.39 27L:t.39 4'@'2.32 422.84 3L:k3.01 367.27 374.23 414.63 407.192 374.65 385.56 -0.01 NOT ON 369.53 492.42 463.15 421.94 341.54 398.79 3SLq.94 347.51 STUDY STUDY STUDY STUDY 430.55 477.34 327.53 421.52 -0.01 NOT ON STUDY 501.?6 0.06 NOT ON STUDY 0 NOT ON STUDY e 0 NOT ON STUDY 4e.2.12 'f-07.84 -326.19 463.52 358.68 412.47 3 5!f-1.3 398.85 495.36 ').01 JOT ON STUDY J67.41 -0.03 NOT ON STUDY 05 iPO4641 02S 43e..is IR04642 02S O-ei 2 PST # IR04642 02S FOODIAR 12S 499..:Lo 12 IP04642 02S 342.71 2 IP04644 02S FNODJAP 12'--- j4C,45 02S IP04646 025 467.01 2 3es.9i 12 412.ee 2 40'!,.OCI 2 FOODJRP 12S 37-..71 12 IP04647 02S :.9e.6@r 1 2 IP04648 02S 301.00 2 FOODIAR 12S 3?9.76 :12 IR04649 02S 249.eS 2 IP04650 02S 4e6.59 2- FOODISP 12S 366.11 :L2 iRO4651 02S TA 320.51 2 0 IP04652 02S -c4.00 2 RAT # IR04652 02S FOODJAR 12S 497.03 :12 iP@4653 02S 479.11 2 IR04654 02S 439.05 2 FOODJAR 12S 276.74 12 IP04655 e2S -0.05 2 PAT # IR04655 02S IR04656 02S -0.05 2 PAT # iRO4656 02S FOODJAR 12S -0.07 12 IR@4657 02S 369.01 2 iRO4658 02S 30@@5.13 2 FOODJAR 12S 4-0'-;.64 12 IP04659 02S 451.17 2 iRO4660 e2S 3@@Ns. 65 2 FOODJAP 12S :?e.2.32 12 TA 0 0 IR04661 02S ZS'7.73 2 lPe4662 02S 36:?.40 2 FQQDJAP 12S 357.47 12 IP04662 02S 3e2.88 2 IR04664 02S -e.e6 2 PAT # IP04664 025 FOOE, JPP 125 52!-.32 ' L2 IR04665 02S 37*3.48 ' 2 iRO4666 02S -e.04 ' 2 RAT # IR04666 02S FOOC,JAR 12S 513. 67 ' 12 IR04667 025 514.55 ' 2 IP04668 02S 423.63 ' 2 FOODJRR'12S IR04669 025 386.94 ' 12 -e.06 1 2 PAT # iRO4669 02S' IR04670 e2S FOQDJRP 12S 461.34 ' 2 4?7.21 ' 12 iRO467i 02S -0.02 ' -2 PAT # IR04671 02S IRe4672 02S 392.49 ' 2 cOODiAR 12S @04673 02S 515.42 ' 12 4L:t4.37 ' 2 IR04674 02S o.ee 2 PAT # IP04674 02S FOODJAP 12S 493.59 12 IP04675 e2S iPe4676 02S 365.12 2 -e.ee 2 PAT 0 iRe4676 02S FOODJAR 12S 490.77 12 43e.is 0.01 NOT ON 4?9.1 :?44-.71 467.01 389.Si 412.ee 405 377.71 399.65 3A.1 399.76 348.e9 4e6.59 STUDY :!20.51 0 NOT ON 497.03 479.11 439.05 376.74 -0.05 NOT ON -0.05 NOT ON -0.07 369.el 355.13 405.64 451.17 35e. 65 382.32 STUDY STUDY STUDY 3L:t7.73 263.4 357.47 382.98 -0.06 NOT ON 525.32 373.49 -0.04 NOT ON 51.3.67 514.55 423.63 386.94 -0.06 NOT ON 461.34 497.21 -ef0.2 NOT ON :??2.49 515.42 484.37 0 NOT ON 4?3.59 365.12 a NOT ON 4SiO.77 STUDY STUDY STUDY STUDY STUDY STUDY 1056 IP04677 025 IR0467e. 025 FOODIAR 12S iPL34679 02S iPLI4680 02S COODJRP 12S @04,Eei 02S lP04iEe2 02S FOIDDJAP 125 IP046e3 e2S iF.'04684 02S FOODJRP 125 iRO4685 02S iPO46e6 02S FOOEliRP 12S IP046e7 02S PAT iPO468e FOODJAR IP04689 PAT # iPO4690 FOODJAR IP0469i IP04692 P.FIT # FOODJAR IP04693 IR04694 FOODJAR IR04695 IR04696 FOODJAR IP04697 iR04698 FOODJAR IP04699 PAT # 02S 12S 025 025 12S e2S 02S 12S 025 02S 12S 025 02S 12S 02S 02S 12S O-US iRO4700 FOODIRP iRO4701 IR04702 FQODJRR IP04702 IR04704 P.FIT # FOODIAR IR04705 FOODJAR iRO4706 iRO4707 FOODJRR IP047es iPO4709 FOODJAP IR04710 IP04711 1 IDJRR IR047i2 IP04713 FOODJRR IP04714 IR04715 FOODJAR TA 02S 125 025 02S 12S 02S e2S 12S e2S 03S 03S 13S o2s 03S 13S 035 035 13S 02S 03S 13S e3s 03S 13S 34 411. 79 41e.58 417.42 471. 9$3 342.40 I-ROS.95 411.?5 2.40.?0 0.01 IR@4687 02S 4 1 :. 5 4?5.60 ' 0.02 ' IR04689 02S 50:1.89 460.12 e.ee IP04692 025 46:1. 81 358.L:19 462.64 402.31 37:L.49 405.77 Zee-@.71 204.25 429.35 370.56 0.00 IP04699 02S 4-26.:L2 ' 492.97 ' 42L:t.00 ' 574.72 ' 359.80 500.59 L3. 0:? IR04704 02S 4-A3.ii 536.33 368.17 347.63 397.95 440-;.52 373.45 4e2.16 219.97 405.09 382.80 297.37 394.1:,! 395.56 272.03 377.72 392.62 e 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 12 3 3 13 3 -3 13 3 3 ii 3 3 13 3 3 13 0 412.76 0.00 NOT ON STUDY 471.95 473.98 566.90 326.97 393.34 41:L. 79 418.58 417.43 471. ge 342.4 509.95 411.95 340.9 e.ei NOT ON STUDY 413.55 495.6 e.e2 NOT ON STUDY 363.45 5ei.es 460.12 L3 NOT ON STUDY 461.81 359.89 462.64 402.31 371.49 405.77 38m-;.71 :?04.25 429.3'-rl 370.56 Li NOT ON STUDY 4:?6.12 492.97 428 !574.72 359.8 500.59 0. e3 NOT ON STUDY 483.it 536.33 479.24 368.17 347.63 3?7.95 @.445.52 373.45 402.16 319.97 405.09 :?82. 8 397.37 :?94.13 395.56 372.03 377.72 382.62 -1057 iRO4716 03S 90 2 iRO47i7 03S 404.17 3 FOOC,;AR 13S 404.21 13 IP04718 03S 464.42 3 IR04719 03S 4.-fO.02 3 FOODJAR 1'-S? :?76. '-Z7 13 1P04720 03S 430.31 3 )4721 03S 374.45 3 FOODJAP 135 --4.7:4L6. 13 IR04722 03S 44:L.lLq 3 IP04722 035 FOODIAR 13S 469.:L4 3 377.62 ' 13 IP04724 03S 358.72 ' 3 IP04725 03S 526-70 ' 3 FOODJAR 13S 354.23 ' :L3 TA 0 e- iPO4726 e3S 443.15 ' 3 lPe4727 OZS --@72.97 ' 3 FOODISP iZS '-739.29 ' :L3 IP0472e o3s 579.51 ' 3 IR047@-9 03S 450.50 ' 3 FOODJAR 13S 346.69 ' 13 IR04730 03S 369.99 3 IP@472i 03S 4e2.22 3 FOODIAR 13S --,,76-93 13 IP@4732 03S 557.33 3 IR04733 03S 363.30 3 FOODIRP 13S 355.55 L-Z IR04734 035 422-73 3 IP04735 03S 0.00 3 PAT # iRO4735 03S FOODJAR 13S 501-26 ' L3 IP04736 035 390.74 ' 3 IR04737 03S FOODYRP 13S 569.5e ' 3 --ec.e.. 0 4 ' 13 IR04738 035 407.34 ' 3 IP04739 035 426.66 ' 3 FOQDJAR 135 372.04 ' 13 IP04740 03S 421.56 ' 3 IR04741 OZS 360.71 ' 3 FOOE,;RP 13S iPO4742 03S 401.3e ' 13 393.53 3 IP04743 03S 534.30 3 FOODJRR 13S 35A-.2e 13 IP04744 03S -e.ee 3 PAT # IR04744 03S IR04745 03S FOODJAP 135 346.5e 3 0-;02.3e 13 IR04746 03S 460.98 3 iRO4747 035 412.04 3 FOODJAR 13S 3 -". 73 13 IP04748 03S 555.95 3 IP@4749 03S 359.26 3 FOODJAP i3S 340.82 13 iPO4750 035 484.63 3 iPO4751 03S -0.00 3- PAT # iPO4751 03S COODJAR izs 4?1.88 13 @04752 03S 487.32 3 IR04753 03S 317.78 3 FOODJAR 13S 372.53 13 IR04754 03S 412.41 3 IR04755 03S 3ele.99 3 FOODJF4P. 13S 3e5.64 13 9?99?99-QI-49 99 0 2SS.g 404.17 4C44. 21 464.42 420.02 376. 37 430.31 374.45 371.46 44:L. :L8 469.:L4 377.62 358.72 526.7 354.23 443.:L5 373.97 339.29 579.51 450.5 346.69 369.99 482.22 376.93 557.33 363.3 355.55 422.73 0 NOT ON STUDY 501.26 390.74 569.5R3ee.. 04 407.34 426.66 372.04 431.56 360.71 401.38 393.53. 534.3 35L:t.28 0 NOT ON STUDY 346.58 502.3 460.98 412.04 355.73 -"5. 95 359.26 340.82 -484.63 0 NOT ON STUDY 49:L.88 487.32 317.78 372.53 412.41 388.?9 285.64 -1058 T"O YEAR OF'RL(DIET) TOX-ONC: STUE)Y OF FM---7'924*-.FC:-143 IN RATS EXP.# 0281CROO12 TEI:IHNICIFIN INITIFILS:S MH TOI)RY-'S C)ATE:S 6/17/82 SEX OF RRTS:S FEMALE ROOt'l NUTISEP:S D-340,D-338 WEIGHT OF FULL FOOD JRR:S 650GRAMS WEEK 58 iRO4576 OIS F.'FTl # IR0457i@ OIS TFI FOODJAR IIS IF'04578 015 F.'.AT# IR045'.'9 OiS FOODJAR ilS IR045SO OIS F'Fil# irl.04581 OiS FOCi[.-.JFiF,115 IR045E:2 OIS F:FIT IR0458@@. OIS FOOE)JAR 115 TFi IR04584 OIS IF'04585 @IS P.FIT # FOO[j.JAF: :LIS IF:045:36 015 IR04587 OIS FQODJRR IIS IR04588 015 r-,'Fi#T IR04589 OIS PFIT # FOOD-JAR IIS IP045@-@O 015 F.'.AT# IP04591 015 FOODJAR 115 IR04592 OIS IR@4593 OIS FOODJRR IR04594 IR04595 IIS eis OIS FQODJAR iiS IR04596 OiS IF'04597 OiS FOOD-JAR itS IR04598 OIS '.1'4599 015 F,-.JDJRR IIS IR04600 015 IR04601 OIS PAT # FOODJRR 115 IR04602 OIS lPr,4603 OIS -Cl.01 IF'04576 OIS 497.82 0 476.56 - Cl.03 IR04578 OIS 464.90 4'c:2.53 -r-1.07 iRO45E:O 015 4 Ee...10@ 497. 04 - Cl.04 IR04582 OiS 347.15 ' @--4.2. 97 ' 0 425.31, ' 0.03 IR04585 OIS 442. 33 63 475.20 2L;9.02 0.00 IR04588 OIS - Cl.C-21 IR@4589 ois o.oci -0. 01 iRO4590 GiS 398.10 515.70 463.71 377.50 397.57 471.47 393.71 332.28 484.04 428.88 3 6.-@7.5 378.76 3 -@O - -X4 422. 29 474.71 0.01 IR04601 OIS 48-c).68 372.48 400.85 1 1 0 it 1 1 11 1 1 li 1 1 11 0 1 1 li 1 1 li 1 1 li 1 1 11 1 1 11 1 1 11 1 1 I:L 1 1 :Ll 1 1 11 1 1 -0.01 NOT ON 497.82 STUDY 476.56 -0.03 NOT ON 464.9 482.53 -0.07 NOT ON 468.18 497.04 -0.04 NOT ON 347.15 642.97 STUDY STUDY STUDY 425.33 G.o:l NOT ON 442.23 391. 63 475.3 369.02 0 NOT ON -0.02 NOT ON 0 -0. o:l NOT ON 398.1 515.7 463.71 377.5 397.57 471.47 393.71 332.28 484.04 428.88 363. 75 378.76 320.34 422.29 474.71 0.01 NOT ON 489.68 372.48 400.85 STUDY STUDY STUDY STUDY STUDY 1059 FOOL@JFIF*. 115 IP@4604 015 IPC'4605 OiS FOODJAR IIS IR04606 015 IR04607 OIS F "# FQODJAR IIS IF-04608 OIS F:FIT # IF*04609 015 FOOE-JRF,' IIS IR04610 OIS PAT # IR04611 OIS FOODJAR ilS IR04612 OIS IR04613 015 FOODJRR IIS IR04614 OIS IP@4615 OIS FOOE)JAR 115 TR IR@4616 ois IF:04617 OIS FOOE)JFIF, IIS IF'04618 OIS IR04619 015 FOOD-JAR IIS IR04620 OIS F.'FIT# IR04621 015 FOODJAR IIS IP04622 015 IR04623 OIS Fr-,Q[.-JFiF,IIS IRA-4624 015 IR04625 015 FOO[)JRR IIS IR04626 GIS IR04627 OIS Fi-JOE-JFiR :LIS IF*04628 015 IF'04629 OIS PAT # FOOL.-JAR 115 TFi IR04630 OIS RAT # IR0463i OIS RAT # FOODJAR IIS IR04632 OIS PAT # IR@4633 OIS FOODJAR IIS IP04634 OIS -14625 OIS F -OE)JAR IIS IR@4626 015 IR04637 OIS FOOE4JAR IIS IR04638 OIS IR046--,'9OIS PAT # FOOD-TAR IIS 4 C,E,- P-7 44,---.. :,E.7.67 454.50 0.03 IR04607 OIS 515.99 ' 0.02 ' IR04608 OIS 397. 61 4 c-94. 71 -0.02 IR04610 OIS 470.30 513.16 3e.7.05 460.01 39C,.37 427.71 419-80 31-;144.3 0 :,72.45 @:<74.47 416.38 424.4:L 380.96 371.25 -0.02 IR04620 015 375.93 ' 517.23 ' 447.84 ' 428.37 ' 375. 5:1 404.55 388.34 --<63.03 436.08 4@.6.7:1 373.39 444.86 -0.05 IR04629 OIS 490. 0:1 0 0.03 IR04630 OIS 0.02 IR04631 OIS -0.00 0.00 iRO4632 OIS 513.11 338.38 464.88 392.82 407.77 365.69 393.50 5C'4.75 0.01 IR04639 OIS 497 36 11 li 1 1 li :1 1 11 1 1 li :1 1 11 1 1 it 0 1 1 11 1 1 11 1 1 it 1 1 :li. 1 1 11 1 1 11 :1 1 11 0 1 1 11 1. 1 li 11 11 1 1 11 1 1 it 408.67 446.28 347. 31 367.67 454.5 CI-03 NOT ON 515.99 0.02 NOT ON --<976.1 499.71 -0.02 NOT ON 470.3 513.16 387.05 460.01 390.37 427.71 419.8 294.43 STUDY STUDY STUDY 372.45 374.47 416.38 424.41 380.96 371.25 -0.02 NOT ON 375.93 517.23 447.84 428.37 375.51 404.55 388.34 363.03 436.08 476.71 373.39 444.86 -0.05 NOT ON 490.01. STUDY STUDY 0.03 NOT ON STUDY 0.02 NOT ON STUDY 0 0 NOT ON STUDY 477.94 513.11 338.38 464.88 3-q2.82 407.77 365.69 393. 5 504.75 0. ei NOT ON STUDY 497. :96 1060 IR04L;40 ois PAT # OR04641 02S IF04642 02S RAT # FOODJAR 12S lRrl4643 02S ! '44644 02S F-L-Ll[).JAF1,25 IR04645 025 IP04646 02S FOOE)JRR 12S IR04647 02S IR04648 02S FOODJRR 12S iRO4649 02S IR04650 025 TFI T fi FOODJAR 12S IR04651 02S IR04652 025 RAT # FOODJAR 125 TF1 IP04653 02S IR04654 025 PAT # FOODJAR 12S iRO4655 02S RAT # iRO4656 02S RAT # FOODJRR 12S IR04657 02S IR04658 02S FOOI)JAR 12S IR04659 025 IR04660 02S FOODJAR 12S IR04661 02S iRO4662 02S FOODJRR 12S IR04663 02S TFI IR04664 025 P.RT # FOODJAR 12S IR04665 02S IR04666 02S RAT # FOODJAR 12S iRO4667 02S iRO4668 02S FOODJAR 12S IR04669 e2S RAT # IR04670 02S F "DJAR 12S ,rr, IR04671 025 PAT # IR04672 02S FOODJAR 12S IP04673 02S IR04674 02S o@ 01 1 iRO4640 OIS 451.98 2 0.04 2 iRO4642 02S 482.68 12 356.35 2 463.97 2 397. 25 12 416.14 2 408.38 ' 2 358. 49 ' 12 414.00 ' 2 289.77 ' 2 399.89 12 355.28 2- 487.63 2 0 0 0 358.61 ' 12 331.29 ' 2 -0.24 ' 2 IR04652 02S 445.94 ' 12 0 0 482.67 ' 2 -0.03 2 IR04654 02S 494.99 12 -0.04 2 iRO4655 02S -0.02 2 iRO4656 02S -0.04 12 372.58 2 353.66 2 420.80 12 2 2 407.06 12 394.73 2 360.29 2 377.04 12 392.69 2 0 a -0. 03 " 2 IR04664 02S 524.29 ' 12 373.72 ' 2 0.07 ' 2 IR04666 02S 507.91 12 465.15 2 437.66 2 461.49 :&2 0.15 2 IR04669 02S 481.05 ' 2 487.60 ' 12 0 0 -0.18 2 IR04671 02S 395.23 2 525.92 12 5e6.71 2 0.14 2 0. oi NOT ON STUDY 451.98 0.04 NOT ON STUDY 482.68 356.35 463.97 397.25 416.14 408.38 358. 4-q 414 289.77 399.89 355.28 487.63 358.61 331.29 -0.24 NOT ON 445.94 STUDY 482.67 -0.03 NOT ON 494.99 -0.04 NOT ON -0.02 NOT ON -0.04 372.5S 353.66 420.8 488.95 367.02 407.06 394.73 360.29 377.04 392.69 STUDY STUDY STUDY -0.03 NOT ON 524.29 373.72 0.07 NOT ON 507.91 465.15 437.66 461.49 0.15 NOT ON 481.05 487.6 STUDY STUDY STUDY -e.is NOT ON 395.23 525.92 506.71 0.14 STUDY 106'1 PFIT IR04674 02S FOOC@JAP J25 492. 7E. 12 IR046f-5 02S 37e.-;2.4'. 2 iRO4676 02S 0.32 2 PAT # IR04676 02S FOOC,JHR 125 510.04 12 1 '4677 02S 409. 5:L 2 It-,,-14F--78 0. 07 2 F.'.Fi#T IR04678 025 FC,OE@JfiF: :L2S 497. 72 12 IF:04679 OZS 486.26 2 IF'04680 02S 577.07 2 FF-il--Il@JAR125 320. 67 12 T Fi 0 0 IR04681 0 c'S;. 2,92.98 2 IR04682 02S 428.6:1 2 FOOD.JRR 12S 9 6. 32 :L2 iRO4682 0 -@'S 4:19. 65 2 IR04684 02S 48:1. 90 2 FOODJAR 12S --1:72.41 12 IR04685 025 5:1.25.:1:. 2 IP04686 025 FOODJRR 12S 422.69 ' 2 349.71 ' 12 IP04687 02S 0.01 2 PAT # IR04687 025 IP04EE:S 02S 413. OZ' 2 FOODJAR 12S 505.7--@: 12 IR04689 02S 0.02 2 F:FLT # IR04689 02S IR04690 02S 376.83 ' 2 FOODJRR 125 4e-9.88 ' 12 IR04691 025 455.13 " 2 IP@4692 025 -0.03 2 PAT # IR04692 02S FOOE)JAR i2S IR04692 02S 408.66 12 382.56 2 IR04694 025 2 FOOE)JAR 125 382.Si ' 12 IR04695 02S 380.42 " 2 IR04696 02S 402.80 ' 2 FOOC-.JFIF,' iZS 391.10 12 IP04697 02S 309.42 2 iPO4698 02S 440.41 2 FOODJAR i2S 382.94 12 IR04699 025 -O.e2 2 F'FIT # iRO4699 025 IP04700 02S 4:31.13 " 2 FOODJAR 125 504.04 ' 12 IP0470i 02S 431.54 ' 2 IR04702 025 587.41 ' 2 FOODJAR 12S 356.03 ' 12 IR04703 02S IR04704 02S RAT # 498.31 ' 2 e.ee ' 2 iRO47e4 02S FOODJAR 12S 484.19 ' 12 IR04705 02S 546.65 ' 2 FOODJAR IP04706 03S 14707 03S F-ODJRR 13S IP04708 03S IP04709 035 TFI FOODJAR 13S 12- --,:64.68 " 3 343.26 ' 3 404.65 ' 13 445.23 ' 3 375.77 ' 3 0 0 3.96.14 " 13 NOT ON 492.76 372-24 0.32 NOT ON 510.04 409. 5:L 0.07 NOT ON 497.72 486.28 577.07 320.67 STUDY STUEJY STUDY 392.98 428.61 396. 32 419.65 4e.:I.9 372.41 532.53 422.69 349.71 0.01 NOT ON 4:13. 02 505.73 e.e2 NOT ON 376.93 489.88 455.13 -0.03 NOT ON 408.66 382.56 478.50 382.81 380.42 402.8 391.1 309.42 440.41 382.94 -0.02 NOT ON 433.13 5e4.04 431.54 587.41 356.03 498.31 0 NOT ON 484.19 546.65 490.54 364.68 343.26 404.65 445.23 375.77 STUDY STUDY STUDY STUDY STUDY 396.14 1062 IR04711 035 FOODJAR 13S IP04712 03S IR047i3 03S FOOE,.JFIR 135 iRO4714 OZS IP04715 FOOC@.JFIF* IP04C-16 0--,S 1:.S 14717 0115 P 13S IR04718 IR04719 FOOE:,JAP. IR04720 O-IS 01-'S I.-@S 025 IR04721 025 FOOI)JAR 135 IP04-22 iRO4-23 FOODJAR OZS 0-15 i3S IR04-24 OaS IF.'C'425 035 FOODJAR 135 TA IF'04C-26 03S IP041-27 0--!@S FOOE)JAR 135 IR04728 03S IP04".729 035 FOODJAR 13S IR04.710 035 iRO4731 FOC,[).JAF,.I --@5: IP@4732 0--,*S IR04-171@3 035 FOODJAR 135 IP047.-;@'4 0 -@5, IR04f@35 0115 FOOE)JAR 125 IR0471-6 035 IP04727 03S FOODJAR IR@47@@8 035 IR04739 03S FOOE-JRR 13S iRO4740 03S iRO4741 03S FOODJAR i3S IR04742 03S IR04743 03S FOODJAR 13S IR04744 03S RFIT # IR04745 03S FOOE)JAR 135 TFI IR04746 03S IR@4747 03S FOODJRR 13S IR04748 03S 1 4749 03S FuoDJAR 135 421.89 3 374.00 13 401.65 3 399.59 3 412. 94 13 383.19 3 --@81-94 3 384.65 13 305.89 3 420.45 3 --<75.74 13 467.105 3 428.46 3 384.52 13 443.10 ' 3 :186.24 ' 3 351.76 ' 13 461.02 ' 3 482.43 ' 3 372.98 ' :13 --@71.24 ' 3 5::3.61 ' 3 342.84 13 0 0 463.79 3 380.76 3 -734.58 13 579.66 3 444.79 3 364.29 13 372.14 3 487.00 ' 3 391. 97 ' 13 564.93 ' 3 353.63 3 371.51 13 426.63 3 3 513.70 13 388.82 3 584.76 3 382.34 13 408.76 3 3 374.33 13 445.44 3 363-39 3 398.37 13 409.30 3 536.42 ' 3 340.63 ' 13 -e.04 ' 3 IR04744 035 349.40 ' 3 500.54 ' 13 0 0 461.92 ' 3 419.35 ' 3 375.7e ' 13 569.61 ' 3 366.22 ' 3 352.41 ' 13 4'-'I@89 374 401.65 :199.59 412. 94 383.19 381.94 394. 65 305.89 420.45 375.74 467.05 428.46 384.52 443.1 386.24 351.76 461.02 482.43 372.98 371.24 533. 61 342.84 463.79 380.76 334.58 579.66 444.79 364.29 372.14 487 391. 97 564.93 353.63 371.51 426.63 0.00 513.7 388.82 584.76 3e2.34 408.76 428.17 374.33 445.44 363.39 398.37 409.3 536.42 340.63 -0.04 ..NOT ON 349.4 500.54 NOT ON STUDY STUDY 461.92 419.35 375.7569.61 366.22 352.41 10 6 IR04750 03S 494.44 3 iRO475i 035 0.03 3 RAT # IR0475i 03S FOODJAR 125 492.53 13 IR0475e'_ 03S 493.01 3 IR04752 FOOE)JRR 13S 329.82 3 3r-.2.58 13 IR04754 035 414.47 3 IR@4755 035 407.31 3 FOODJRR 13S 392.99 13 9999999999 99 0 494.44 0.03 NOT ON 492.53 493.01 329.82 362.58 414.47 407.31 392.99 STUDY 1064 Tiq@'iYEFIF, ORFIL(@E@IET) STUDY OF F@1-2-q,24 & EXP.0 TECHNIC:IRN INITlf4LS:S SW TOEAFily'-"DSRTE: S 7,,11.,/e2 SE@@ OF RATS.S FEMALE ROOM NUMBER:S D-340,D-338 WEIGHT OF FULL FOOD JAR:S 650GRAMS FC@-143 IN RATS 02181CR0012 WEEK 60 IR04576 OIS PAT * iRO4577 OIS TA FOOE)JAR IIS IP04578 015 PAT # IF'04579 OIL FOOE,JFTP. IIS IF'045eO OIS F'FIT # IF:045SI 015 TFi FC,O[-JFiF,,:LIS IR@4582 015 R.'FTl # IR045e! 015 FC,Cll,JRF@ IIS IF'04564 OIS OIS F'FlT T Fi FC,O[@JFiF, ll!F. IF'045e6 OIS IF:045*7 OIS FOOE-JRP IIS IF@045i:*@:, OIS fl.RT # I P @-14 5 E.*,-7,015 F,FIT # F C,Cll,JFIF: I 1 IR04590 OIS PHI # IR04591 eis FOODJRR IIS TFI IR04592 OIS IR04593 SIS TFI FOODJAR 115 TA IF:04594 015 IR04595 OIS FOODJRP IIS 114!f-,--4O6IS 1W04597 OIS F CIOL)JAP IIS IR04598 OIS IP&45?9 015 FOODJAR IIS IR046CIC4 OIS F.*C-14$Z.A-101 C; 0.10 IR04576 OIS 492.94 ci 470. 7 IF'04578 OIS 4 E.ri.32 475. 84 -Cl.oci IR045&0 015 4.-:1.25 Ci 500 22 -0.00 IR04582 OIS 432.06 45C-. 91 401.32 - Cl.2 1--1 IP04585 015 0 451. 8--,: 399.47 4 1E.1'.-7;7 7 5. --8@ - Li.0 i4 IR04588 OIS - Ci.09 IF*04589 015 -0. 12 -0.14 IR04590 015 405.40 ' 49e..74 " 0 471.79 ' 387.12 ' 0 359.70 ' 0 462.62 ' 15 ' 372.62 ' 4 8 C-i.96 43Z.7C' -@44. 74 $84. 01 321. 5--l 375.92 469.37 ' 04 ' 1 0.10 10 -0.182 :1 11 I -0.00 1 0 11 1 -0.00 1 :Ll 1 1 -0. 2cl 0 11 1 1 -0.09 -0.09 -0.14 1 11 0 1 1 0 it a 1 I11 1 1 li 1 1 11 1 0.1 NOT ON 492.94 STUDY 470. 7--z -CI-02 NOT ON STUDY 460. 32 475. C-c4 cl NOT ON STUDY 471. 25 5C90. 22 0 140T ON 432.06 45e.. 91 401.32 -0. 2 NOT ON STUE)Y STUE-IT' 4 5 1. rd--399.47 469.77 375.38 -0. 09 NOT ON STUDY -0. O-q NOT ON STUDY -0.12 -0.14 NOT ON STUDY 405.4 498.74 471.79 387.12 359.7 462.62 :189. 15 372.62 480. 96 422.7 344. 74 3rd4. 01 321.52 375.92 469. 37 -Ft04 .1065 F'.FTT FoCi[@-.jFIF'IIS IR0460.C-@' OIS lRCj4E.C4! OIS FOOE-JAF' IIS IR04604 OIS -..C'4605 015 FCir-iL@iFiF.ll:E. T Fi IF*04606 01--, IRrj46O.- CIIS F.'FIT# FCi,DDJFiF*. 115 IR04608 OIS PAT # IR04609 015 FOODJAR IIS IR@4610 015 F,'FIT IR04611 015 FOCo[).JFiR IIS IP@4612 OiS IR@4613 OIS :LIS TFI IF:04614 OiS IF:04615 015 FCIQEJ JAR 115 IR04616 OIS IR04617 FOODJRR 015 ilS T Fi IR@4618 OIS IF'04619 OiS FOODJAR IIS IR04620 OIS F'.FIT# IR@4621 OIS FCiO[.,.JFiRliS IP@4622 OIS 1 F'O 41--.22 OIS FOC,E)JFiF,I,IS IR046'@7'4 015 IR@4625 015 FCIOLA.JAP. ilS IR04626 OIS IF:04627 015 FOODJAR ilS IR04628 OIS IR04629 OIS F@AT TA FOOC,JAR iiS IP04630 OIS RAT # IF:A-4621 @IS F11- # F, .@)JFIF'l.iS OIS F,FIT # IR046S--' OIS FOOE)JAR 115 .TFl IR04634 0.07 OIS IR04601 015 5 C, 87 z 7@1IE..I_0;, 29 9 2,c@ 451.65 0 :@52. E-4 -@8 4. IE. 0 452.74 -0. 01 lRt-L'4607 OIS 490. 28 -0.00 IF,'04608 Oi:E40a. 9:< 4e.8.86 -0.00 IF:04610 OIS 491.2E. 47::. 88 -;"C@7. 38 470.51 8 5. 92 424.43 42E.. 54 386. 67 '@-1'.9.07 :48 P--,.Big ci 425.15 29 '78. 3 0 -0.04 IR04620 015 3.59.35 ' 502. 41 " 4--13.86 ' 434. C,9 ' 361. 93 ' 401.31 ' 8 4. 09 5-i..37 442.29 474.40 336.34 444.11 0.27 ' IR04629 OIS 0 499.60 ' -Cl.06 1 iRO4630 OiS -0. 12 iRO4631 015 li -0.11 IR@46--12 OIS 4.c-c$.47 ' 498. 82 ' 0 '0 324.19 ' -0. ci4 11 1 1 11 1 0 -0.01 -0.00 -0.00 1 11 1 1 11 0 1 1 11 1 1 11 0 1 1 11 1 -0.04 1 11 1 1 11 1 1 11 1 1 li 1 1 0.27 0 li 1 -0.06 1- -0.12 11 1 -0.11 1 li a 0 1 NOT ON 5 C' e.7 -@7:E..8 39:?. 29 28 451.65 STUDY -<52. 64 384. 16 45--<.74 -ei.o:l NOT ON 490. 28 0 NOT ON 4 0 --. -@Q':<: 488.86 0 NOT ON 491.26 473.88 387.38 470. 51 385.92 STUDY STUDY STUDY 424.43 42E.. 54 386.67 363.88 391. la7 386.86 425.15 :@8!5. 29 378. 3 -Ci.04 NOT ON 359.35 502. 41 433.86 434. 09 361.93 401.31 384.0-q 353. 37 442.29 474.4 Z@36.34 444.11 0.27 NOT ON STUDY STUDY 499.6 -0.06 NOT ON -0.12 NOT ON -0. -0.11 NOT ON 488.47 498.82 STUDY STUDY STUDY 334.19 1066 015 41-7. !51 F OOL@J RP IIS --0,,.1:., ciE: 11 I P.C,4 --1-6 OIS 41--@'6.2 1 IF:04617 OIS --,,6671. 1 F C1iI-L--JFiF,.:11-q 5.- 11 1 F -C,4 6 --8@ 015 4-;16.82 1 lprl4E..9 ois F., FI-ILIJCF,IF* IIS IF:Li4o:F4O OIS I-, I Is 7 11 E. 1 F*RT # IF:04640 OIS IF:04641 OZS 2 IF'C'4642 025 F,*FIT# FOOE)JRR 125 IR0464-;, 025 IP04644 0-@'S FOOE:,.JFiR. 12S IR04645 02S IP04646 02S FOOC@JRF, iZS IR@46417 0 -@Z'S IP04648 02S FQOEjJFiF,. 12S IR04649 OZS IR04650 02S FOOL@JHR 1--S IR04651 02S IR04652 025 F'.FIT# FC,OD.JRR 12S IR0465a 02S IP04-654 02S F;.'FIT FOC,D.JRR 125 IP04655 F'RT # IR04E.56 02S P.Fil# Fl--IOLYJFiF,.125 IR04657 02S IR04658 OZS FOOE)JAR 1-@,5 IR04659 02S IP04660 02S FOOL)JAR 12S IR04661 02S IR04662 02S FOCIDJAR 125 1R04663 02S IR04664 02S RF-IT 0 TA FOODJAR 125 IR04665 02S IPC,4666 02S F.'FI#T il.J-FIR I,el;. 02S IF'04668 025 FC,Cll,JFTP. 1,-7,S 1 F.'O4 9 02S F.'AT 9'0497A APS Cl. 06 2 IR04E.42 02S 475,19 12 :@5or. 34 2 474.51 2 47 12 415.8o-- 2 417il2.@- -*' 2 -@4. 7. Z,L; 12 4:19. 27 2 77 2 2. 52 12 --<58.7--< 2 489.64 2 --@5:@.--9< 12 54 ' 2 -0.02 ' 2 IF:04652 025 44'-;.97 12 489.20 2 -0-02 2 IR04654 02S 48:E. 40 12 -0. C-1--- 2 I F.r-4iC-5.5 02S -Cl. @34 2 IR04656 025 -0. 02 12 --@.72.CIO " 2 _--,82.90 2 -_E":, @.. --@3, 12 446.06 2 36 2 379.28 12 393.9cl 2 362.26 2 -@5 2. 35 ' 12 415-25 ' 2 0. 66 2 IR04664 025 0 509.41 12 375. 96 ;;F -0.17 ' 2 IR04666 025 512. iE. ' 12 0 419. 54 ' 2 4 --6@. 15 2 440. 50 12 -a. 13 2 IR04669 02S 47i 47 0.12 -0.06 0.06 -0.02 -0.02 -0.03 -0.04 0.66 -0.17 -0.13 477. 51 08 41.3. 62 :i6.@.61 3,cce..57 496. 82 Cl.12 NOT ON 487.97 -0.06 NOT ON 458.00 STUDY STUDY 0.06 NOT ON STUDY 475.19 256. 34 474.51 383. 47 415.8 401. 23 347.26 419.27 28:.. 77 392. 52 358.73 489.64 353. 39 335. 54 -0.02 NOT ON STUDY 449.97 489.2 -0-02 NOT ON STUDY 488.4 -0.03 NOT ON STUDY -0-04 NOT ON STUDY -0-02 372 382.9 385. 3:< 446.06 374.36 379.28 393.9 362.26 352.35 4:15.25 0.66 NOT ON STUDY 509.41 375.96 -0.17 NOT ON 512. 16 STUDY 419.54 436.15 44ri.5 -0. 13 NOT ON 47,c;47 STUDY 1067 I Ft IF:Ci,1671 02S RAT # IF.*04672 02S FCiC,[:-.JFiF1,25 '-)4,E.7.0@2S -.,04674 OZS F'FIT T Fl FC,Cl[.,JFiP12S IF:04675 025 IF'04676 02S F:FTT # FOC,[.,-JFiR :12S IF'04677 025 IR04678 025 PAT # FOOL)JRP 12S IR04679 02S iRO4680 02S FC,ODJRR 12S TFI IR04681 02S IF'04682 025 FOOD-JRP 12S IR04683 02S IR04684 02S FOODJAR 125 IR04685 025 TFI IR04686 02S FOOE)JAR 12S IR04687 02S PAT # IR04688 02S FCIODJAR 125 494. f,9 0 ci.0--, IR04671 C'--'S '-Z9. 4. 5-E,' 509. 8C' 5 45 -0. 15 IR04674 0'-S' C4 479. 2Ci 7 0. 43 -0.04 IR04676 025 501. 30 401.82 -0.04 IP04678 02S 498.81 4-q7.83 574.24 38. 42 290.41 429. 01 376.82 433.97 ' 480.37 ' 351.93 ' 560.40 ' 0 419.85 ' 328.58 " -0. 12 ' IR04687 02S 415.70 ' 490.89 ' 12 r_i 2 ei.El 2 12 2 2 -0. 15 0 12 2 2 -0.04 12 22 -0.04 12 2 2 12 0 0 2 2 12 2 2 12 2 0 2 12 2 -0.12 2 12 494.59 Cl.ri:@. NOT ON 2-c14.58 5 0.9. e, 503.45 -0.15 NOT ON STUDY STUDY 479. 2 :170. 4:@ -0.04 NOT ON 501.3 401.82 -0.04 NOT ON 498.61 49f-.83 574.24 :<38. 42 STUDY STUDY 390.41 429. 01 376.82 433.97 480.37 351.63 560.4 419.85 328.58 -0.12 NOT ON 415.7 490.89 STUDY T Fl IR04689 025 PAT # IF'04690 02S FOOE-JAR i2S IP04691 025 IR04692 025 RAT # FOODJAR 12S TA IR04693 02S IR04694 02S FOODJAR 12S IR@4695 02S IR04696 02S FOO[)JAR 12S 1'-'4697 025 It.--4698 025 TFi F,DODJRR 125 IP@4699 025 F'.F-i#T IR04700 02S TFi FOODJRP 12S ci o.ot3 iRO4689 02S --7< 6. 65 499.87 470.16 -0.17 IR04692 02S 421.94 ' 0 373.51 ' 471.54 402.74 375.01 402.59 390.15 2.07.23 427.86 0 386.96 -0.04 IR04699 025 421.79 0 507.22 0 2 0.00 2 12 2 2 -e.17 12 0 2 2 12 2 2 12 2 2 0 12 2 -0.04 2 0 12 0 NOT ON 376.65 499.87 470.16 -0.17 NOT ON 421.94 STUDY STUDY 373.51 471.54 402.74 -375.01 4CI2.59 390.15 307.23 427.86 386.96 -0.04 NOT ON 421.79 STUDY 507-22 1069 IR04 i@01 02S IR04'.702 02S FOOE)JRR 12S IR04703 025 0 6-@S FOOE)JAR 12S 1 4705 025 FOODJAR IF'04706 03S IR047C47 0'-S@ TFI FCIOC-.JFIF.':13S IR04708 025 IR@4709 035 Fl--,Cll).JF:i1R3S IR04710 035 IRC,4711 035 FOOD-JAR 135 IR04712 035 IR04711 OZS FCiOC-.JFiP. 1.3S TFi IP04714 035 IF:04715 03S FOOE)JAR 135 IR047ig 03S .IP@4717 035 FOODJAR 13S IR04718 035 IR047i9 03S FOODJAR 135 IP@4720 035 IR047i:-@l 035 FOOE)JAR 135 IR04722 02S IR04723 03S 'TR FOODJAR i3S IR04724 03S IR04725 03S FOODJAR 13S IR04726 03S IR04727 03S FOOC-.JAR 13S IR04728 03S TFI iRO4729 03S FOODJAR 13S IR04730 03S IR0473i 03S FOODJAR 13S IP04732 03S IR04733 03S FOODJAF: 13S IR04'r--@:403S ir..,0472503S F'.FIT# FOODJAR 13S IP04f-16 03S IP@4737 03S TF1 FOODJAP 13S 4 2 81 591. 2,--# 76 500.29 -0. 02 IR04704 025 483. 82 54E,*.22 :,,47.91 389. 91 442.80 388.23 376. 32 323. 9,E 424.51 404.02 291.57 ' 395. 32 " 0 379.52 ' I-8 C-;,5. 3 ' 366.49 ' 305.77 ' 4:@2.58 ' 379.80 ' 467.75 ' 441.05 ' 402.60 ' 438.63 " 38.-@.44 ' 360.71 ' 467.22 ' :,74,44 384.77 53LI.i3 359.32 459.90 372.70 319. 19 591a.00 ' 472.78 ' 342.41 ' 362.e6 489.35 ' 413.22 ' 565.69 ' 353.04 ' 385.75 ' 427. 56 ' 0 -0. 02 IR04735 035 509.95 398.60 594.30 0 126 73 2 12 2 2 -0-02 12 2 12 3 3 0 13 3 3 13 .3 3 13 0 3 3 13 0 3 3 13 3 3 13 3 3 13 3 3 13 3 3 0 13 3 3 13 3 3 13 3 0 3 13 3 3 13 3 3 :11 3 0 3 -0.02 13 3 3 0 13 42-1.Si 591. 39 7L:t 5riCi.29 -0. 02 NOT ON STUDY 483.82 548.22 464.06 367. 69 247. 91 389. 91 443.8 388.23 376. 32 323. 96 424.51 354.47 404.02 391.57 395.32 379.52 382.53 i66.49 305.77 432.58 379.8 467.75 441.05 4e2.6 438. 63 383.44 360.71 467.22 475.03 374.44 384.77 530.13 359.32 459.9 372.7 319. 19 590 472.79 342.41 362.06 489.35 413.22 -565.69 353.04 385.75 427.56 -0.02 NOT ON 509.95 398.6 594.3 STUDY -1,-$7;3 1069 IF'04738 03S IP04'.-'@29 03S TF1 FOODJAR i@'S IR04740 035 IR0474i 03S ocjjFlF.,135 IP04742 03S IF'04 .4-,,OZS FoCil@-.-TFlF'1..--S@ IR04'.@'44 025 F.'RT # IP04'.@'45 01-5 FOOE)JRP. 13S IP041-46 03S IR@4"@'47 035 FOOE)JAR 12S IP04748 03S IP04749 03S FOODJFIP 13S IR04750 OZS IR04751 OZS F:FIT # FOODJAR IP04752 1-11S 035 409.45 424.30 0 377. 82 9 7-@. 43 ' 0 411.70 " t,5 ei.9 '@7@-9*. se -0.07 IR04744 03S :,47.70 497, 94 459.61 415.70 341.94 576.9ri 374.83 --@30.78 5:10.46 IR04f@51 03S 484.68 ' 3 3 013 2. 3 13 0 3 3 13 3 -e.07 3 13 3 3 13 3 3 13 3 3 NOT ON STUDY :I-" 3 . 409 45 424.3 :.7-178.2 442.97 360.17 393. 43 411.7 550.93 339.88 -0.07 NOT ON 347.7 497. 94 459.61 415.7 341.94 576.9 374.83 330.78 510.46 0.02 STUDY 484.68 502.21 IR04751-. 07-S TR FOOE)JAR i3S IR04754 03S IR@4755 03S TA FOODJAR 13S 9999999999 327.52 ' 3 0 0 354.97 ' 13 406.34 ' 3 421.02 ' 3 e 0 321.83 ' 13 99 0 327.52 354.97 406.34 421.02 321.83 1070 TWO YEAR DRAL(DIET', TC,,,...'-CSITNUCD:Y OF FC-14-@. IN P.ATS E:,@F'. 0281CREiCll2 TEC@HN11--IFININITIFILS:S Sw TOC)A'T"'SDATE:S 7/15,,*82 SE': OF RRTS:S FEMFILE PC-L t4UMEIEP,:S C--340.c@-.-s3e. WEIGHT OF FULL FOOD JRR:S 650GRAMS WEEK 62 IF'04576 015 PAT # IF'045f-7 OIS FOODJAR IIS IR04578 OIS PFIT # . IP045.-9 OIS FOODJAR IIS IR04580 OIS F.FIT # IR04581 015 FOODJHR 115 IP'04582 OIS F.'RT # IR0458.-@: OIS FOODJAP IIS IP04584 OIS TFI IR04585 OIS F'.FIT# FOOC@.JAF: IIS TFI IR04586 015 IR04587 OIS FOOD JFLF,.IIS IR0458E: 015 F:FIT# IF'04589 015 PFIT # FC,f--i[,@-JAIRIS IR04590 OIS PAT # IR04591 FQODJRR IR04592 IP04593 FOODJAR IR04594 IR04595 FOODJAR IP04596 IR04597 FOODJRP 1*04598 )4599 FDODJRR IR@4600 IP0460i PAT 0 OIS IIS OIS 015 IIS OiS OIS IIS OiS OiS IIS @IS OIS IIS OIS OIS FOODJAR ilS IR04602 OIS 1 re@'44$:A.1ri-t -0.02 IR04576 OIS 517.-AO 467. 16 0. 01 IR04578 OIS 4-5.22 " 475.58 ' 0.03 " iRO4580 OIS 4 @l1,.' 65 5C-17.60 -0.04 IR04582 015 447.11 504.63 378.06 0 0.00 IP04585 OIS 484. 73 0 396.08 467. 60 381.05 -0.08 IR04588 OIS -0. 05 IR04589 015 -0. OCi -0.06 IR04590 015 404.09 ' 519.42 ' 489.47 ' 412.00 ' 342.82 ' 439.42 ' 393.02 373.26 457.49 444.94 364.63 -@74.26 -@2 3. 0 -10 4C'2.17 489.69 -0.02 IR04601 OIS 479.79 ' 384.25 ' 414 IA 1 -0.02 :1 11 1 0.01 1 11 1 0.03 1 li 1 -0.04 1 11 1 0 1 0.00 :li 0 1 1 -0.08 -0.05 1 -0.06 111 1 1 11 1 1 -0.02 11 1 1 -0. ez, NOT ON STUDY 517 44E..-1.6 C4.01 NOT ON STUDIT' 475.22 475.58 0.03 NOT ON STUDY 481. 6c-i 507.6 -0.04 NOT ON STUDY 447.il 504.63 378.06 0 NOT ON STUDY 484.73 396.08 41-:.76. 381.05 -0.08 NOT 014 -0,05 NOT ON -0.05 -0.06 NOT ON 404.09 519.42 489.47 412 --<42.82 439.42 393.02 373.26 457.49 444.94 364.63 --r@-4:. 2 6 323.09 402.17 489.69 -e.rj2 NOT ON 479.79 384.25 414 1A STUDY STUDY STUDY STUDY 1071 FCICII-JFIF@ IIS IF'.Cl4E.CI40:1@-z I P.Cl4 m-C-,5 OiS FCICIE,.JFiF'1. 15 IF:04606 OIS IF'04607 015 P"T # . IC)JAR IIS IF'0460e 015 F'RT # IF:04609 OIS F0014JAR IIS IP04610 015 PAT # IR04611 FOODJAR OIS ilS IR04612 OIS IF'04613 015 FOODJRF' 115 IR.C'4614 OIS IR04615 015 FC,OC,JRR 115 IR041-1-16015 IF'04617 OIS FOOE..JAR 115 TFi IR04618 GiS IR04619 FOODJAR IR04620 P.FIT # IR04621 FOOE)JAR IR04622 PAT # OIS 115 015 015 :LIS 015 IF*04622 FOODJAR IR04624 IR046-:@'5 FOOD.;AP IP04626 IP04627 FC,Cll,JAR IF'04628 IP04629 F'RT # FOODJRR IR04630 RAT # OIS 115 OIS CIS 115 OIS OIS IIS OIS OIS iis OIS IR0463i OiS PAT # FOODJRR IIS iRO4632 elS PAT # IR04633 OIS FOODJAR IIS Toz, 1 4634 OIS IF04625 OIS FC,OUJAR IIS IR04636 OIS IR@4637 015 FOODJAR IIS IP04638 OiS IR04639 015 0 4 5 88 6 64 8OE...-:@ 4 Z@'. 84 &3. Ci7 IR04607 OIS 507. 27 -0.08 IR04608 OIS 411.78 5C'O. 75 -0.08 IR04610 OiS 488.24 510.42 395.68 46L@.33 380@L6.0 425.16 429.96 40j-.09 --7< 0. 61 404.49 38'Z..-17 0 422.94 390. :1:1 380. .In 0.05 IR04620 OiS 349.12 524.88 0.02 IR04622 015 432.37 ' 454.46 ' 410.73 ' 390.53 " @156.81 446.03 40@LO2,8 -iP:-1-.. 77 465.83 0. is IR04629 OiS 49:1.47 -0.03 IR04630 015 -0.02 iRO463i OIS 0.02 0.03 IR04632 OIS 448.29 548.93 0 1-39.37 457.86 41(@.74 406.11 4r-49.46 520.16 -0.09 -0.07 li 1 :li 1 1 11 1 1 11 1 1 11 1 1 11 0 1 -0.08 -0.08 1 11 :L 0.05 1 11 1 0.02 1 11 1 1 li 1 1 11 1 1 e.ie 1:1 1 -0.03 1 -0.02 11 1 e.e3 1 110 1 1 11 1 1 11 1 1 45E.. 88 E.-@'E.4 E:6. 73 4E.S. 84 Cl. lafNOT ON 507.27 -o.cie NOT ON 411.78 50CI. 75 -0.08 NOT ON 488.24 510.42 295.68 463.33 386.6 425.16 429.96 407.09 170. 61 404.49 383. 37 STUDY STUDY STUDY 432.94 390. 1:1 380. 38 0.05 NOT ON 349.12 524.88 0.02 NOT ON 432.37 454.46 410.73 390.53 356.91 446.03 460.38 361. 77 465.83 0.18 NOT ON 481.47 -0.03 NOT ON -0.02 NOT ON 0.02 e.e3 NOT ON 448.29 548.93 STUDY STUDY STUDY STUDY STUDY STUDY 339.37 457.86 417.74 406.11 380.61 409.46 520.16 -0,09 1072 PAT # FOODIAR iiS IR04640 OIS F'PT TA IR04641 025 IP'44642 025 r-. FOO[I JFIF.'12S IR04642 02S IR04644 025 FOOC)JAR 12S IR04645 02S IR04646 02S FOODJRR 12S IR04647 02S IR04648 02S FOODJAR 12S iRO4649 02S IR0465o e2s FOODJPP 12S iRO465i e2S IP04652 02S R<FIT # FOODJAR 12S IR04653 02S IR04654 025 PAT # FOODJAR 12S IR@4655 02S RAT # IR04656 025 RAT # FOODJRR 12S IR04657 025 iRO4658 02S FOODJAR 125 IR04659 02S iRO4660 02S FOOD-JAR 12S IR0466i 02S IR04662 025 FOOE)JAR 12S IR04663 02S IR04664 02S RAT # FOODJRR 12S IR04665 02S IR04666 02S PAT # FOODJRR 12S IR04667 02S IR04668 02S FOODJAR 12S IR04669 02S RAT IR04670 02S FRIODJRP 12S . 34671 02S PAT # IR04672 e2S FOODJAR 12S iRO4673 02S IR04674 02S PAT # FnnD.Tsp 12S iRO4639 OIS 488.00 -0-08 IR04640 OIS 0 464.70 -rd.13 IR04642 02S 471. 77 :<69.0f483.98 377.06 426.67 411.48 365.67 422.87 293.32 39:1. 09 366.48 510.95 351.24 331.88 -0.08 iR@4652 02S 480.44 ' 486.47 ' -0.04 ' IR04654 e2S 500.67 ' 0.04 ' IR04655 e2S 0.00 ' IR04656 02S 0.09 ' 378.57 ' 371.41 ' 411.56 ' 453.09 ' 377.62 ' 396.11 405.15 371.e7 379.45 407.43 -0.03 iRO4664 02S 533.52 ' 385.04 ' 0.00 iRO4666 02S 510.31 378.00 460.28 416.44 -0.03 IR04669 02S 484.91 505.60 -0.04 iRO4671 02S 405.91 518.67 510.94 -0.03 IR04674 02S 501 64 -0-09 NOT ON STUDY 11 488 1 -0.08 -0-06 0 NOT ON STUDY 2 464.7 2 -0.13 -0.13 12 2 2 12 NOT ON 471. 77 369.07 4e.3.98 377.06 STUDY 2 426.67 2 411.48 :12 365.87 2- 422.87 2 293.32 1.2 391.09 2 366.48 2 510.95 12 351.24 2 331.88 2 -0.08 -0.08 12 NOT ON STUDY 480.44 2 2 -0.04 486.47 -0.04 NOT ON STUDY 12 500.67 2 0.04 0.04 2 e.oe 12 2 2 12 NOT ON 0 NOT ON 0.09 378.57 371.41 411.56 STUDY STUDY 2 453.09 2 377.62 12 396.11. 2 405.15 2 371.07 12 2 2 -e.o3 12 2 2 379.45 407.43 -0.03 NOT ON 533.52 385.04 0 STUDY 0.00 12 2 2 12 NOT ON 510.31 378 460.28 418.44 STUDY 2 -0.03 -0.03 ' NOT ON STUDY 2 484.91 12 505.6 2 -0.04 -0.04 ' NOT ON STUDY 2 405.91 12 519.67 2 518.94 2 -0.03 -0.03 12 NOT ON STUDY 503 64 10-73 IP04675 O@'S IR04676 02S PAT FOODJRP IR04677 IR04678 P'-'T# . )DJRR IP04679 IP04680 FOODJAR TFi IR046SI iRO4682 FOODJRR IR04683 iRO4684 FOODJAR iPO4685 IP04686 FOODJRR IR04687 RAT # IR04688 FOODJAR IR04689 F'.AT # IP04690 FOODJAR IP@4691 IR04692 RAT # FOODJAR IR04693 iRO4694 FOOD-IRR IR04695 IR04696 FOODJAR iPO4697 TFi IF'04698 FOODJRR IR04699 PAT # IR047oo FOODJAR IR04701 IR047e2 FQODJRR iRO4703 IR04704 RAT # FOODJAR iRO4705 PAT # 12S 025 02S 125 0--,S 02S 12S 02S 02S 125 02S 02S 12S 025 02S 12S 02S 02S 12S 02S 02S 12S 02S 02S 12S 02S e2S 125 02S 02S 125 02S 02S 12S 02S e2S 12S 02S 02S 12S 02S 02S 12S 02S IR04706 03S 392.35 -0.08 IR046@6 02S 481.97 413.e5 -0-05 IR04678 025 492.42 ' 50--,,.51' 597.94 ' -,,'72. 6 0-; ' 0 395.03 ' 437.87 ' 414.92 ' 439.92 ' 489.63 ' 360.87 ' 575.94 432.12 ' 362.03 ' -0.03 IR04687 025 4:12.06 @ 492.08 ' -0.04 ' IR04689 025 387.80 ' 506.iS ' 462.43 ' -0.05 IR04692 02S 428.05 393.34 484.96 387.71 380.19 405.09 309.43 0 4 --3Z. 17 395.18 -0.06 IR04699 02S 429.49 ' 501.60 ' 435.91 595.18 363.79 509.04 -0.04 IR04704 02S 495.08 ' -0.05 ' iRO4705 02S :192.35 2 -0.08 -0.08 NOT ON STUDY 12 481.97 2 413.85 2 -0.05 -0.05 NOT ON STUDY 12 492.42 2 503.51 2 597.94 12 327.65 0 2 395.03 2 437.87 12 414.92 2- 439.92 2 4S9.63 12 360.P,7 2 575.94 2 432.12 12 362.03 2 -0.03 -0.03 NOT ON STUDY 2 432.06 12 492.08 2 -0.04 -0.04 NOT ON STUDY 2 387.8 12 506.18 2 462.43 2 -0.05 -0.05 NOT ON STUDY 12 429.05 2 393.34 2 484.96 12 387.71 2 380.19 2 409.47 12 405.09 2 309.43 0 2 433.17 12 395.18 2 -0.06 -0.06 NOT ON STUDY 2 429.49 12 501.6 2 435.91 2 59 5.18 12 363.79 2 509.04 2 -0.04 -0.04 ' NOT ON STUDY 12 495.08 2 -.0.05 -0.05 ' 2- NOT ON STUDY 338.63 iPO4707 03S FOODJAR 13S iRO4708 03S IR04709 03S FOODJAR 13S IR047le 035 348.60 3 4-77.03 13 455.14 3 39rd.41 3 377.83 1.3 326.74 3 348.6 437.03 455.14 390.41 377.e3 326.74 1074 IP04711 FOODJAR iRO4712 IR04713 FOODJAR IR04714 IRA4715 F DJRR IR04f-16 IP@4717 FOQDJAR IR04718 IR04719 FOOE)JAR IR04f-20 IR04721 FOODJAR IR04722 IR04723 FOODJAR IR04724 IR04725 FOOD-JRR IR04726 IR04727 FCTOI)JAR IR@4728 IR04729 FOODJRR iRC4730 iRO4731 FOODJAR iRO4732 IR04f-'@13 FOODJRR IR04734 IR@4735 R.FIT # FOODJRR IR04736 IR04737 FOODJRP IR04738 IR04739 FOODJAR IR04740 IR04741 FOODJAR iRO4742 IR04743 FOODJRR IR04744 PAT # iRO4745 FOODJRR IR04746 IR04747 FNODJAR . 34748 IR@4749 FOODJRR IR04750 IR04751 RAT # FOODJRR IRA4752 03S 13S 03S 03S 13S 03S 03S 13S GZS 03S 13S 03S 03S 13S 03S 03S 13S 03S 0'-'S 135 03S e3s 13S 03S 03S il-S 035 035 135 03S 03S 13S 03S 035 1--,S 035 03S 135 03S 03S i3S 03S 03S 13S 03S 03S 13S 03S e3S 13S 03S 03S 13S 03S 03S 13S 035 03S i3S 03S OZS 13S PIS 435.55 40--@.'.54 403.47 398.82 387.71 387.48 398.30 312.94 44--,.85 293.31 471.98 438.74 381.4',0 443.72 388.91 379.e3 4eO.68 478.92 364.83 394.02 ' 54e..94 ' 316.94 ' 476.65 ' 395.24 ' 344.44 ' 607.26 ' 468.90 ' 314.85 ' 368.65 ' 497.27 ' 393.78 569.75 359.67 366.19 436.85 0.69 IR04735 03S 508.24 ' 391.28 ' 601.69 400.02 416.58 439.61 399.46 453.87 365.74 405.92 422.53 556.72 ' 370.96 ' 0.03 ' iRO4744 03S 357.51 ' 495.90 ' 465.07 ' 413.77 ' .394.17 ' 574.44 ' 274.09 ' :,62.48 ' 515.54 ' 0.26 ' iRO4751 03S 494.92 ' 9An A4 ' 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 313 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 313 3 3 13 3 3 13 0.69 0.03 0.26 435-55 387.3 403.54 403.47 398.82 387.71 3S7.48 398.3 312.94 443.85 393.31 471.98 438.74 381.48 443.72 388.91 379.83 480.68 471B.92 364.93 394.02 548.94 316.94 476.65 395.24 344.44 607.26 469.9 314.85 368.65 497.27 393.78 569.75 359.67 366.19 436.85 0.69 NOT ON 508.24 391.28 601.69 400.02 416.5e 439.61 399.46 453.87 365.74 405.92 422.53 556.72 370.96 0.03 NOT ON 357.51 495.9 465.07 413.77 394.17 574.44 374.09 362.48 515.54 0.26 NOT ON 494.92 nrl'%,R4 STUDY STUDY STUDY 1075 IR0475@ 03S FOODJAR 13S IR04754 03S iRO4755 035 FOODJAR 13S 9999999999 336.76 ' 3 372.70 ' 13 406.97 ' 3 419.73 ' 3 368.95 ' :13 99 336.76 372.7 406.97 419.73 368.95 1076 TT-JCIYEFIF'.OF:FiLt.[-IET..TO'@-*-Ot-JSCTU[.'-TO'F FM---':?--*&4 FC-141- IN E;:,*.P. 0281CROO12 TECHfAICIRt4 INITIRLS:S SW To[.,,FiY-'ES)FITE:S 7/29,18,.-@ SEX OF P.FITS:S FEIIFILE F-C.iCit-It-U4tie.E r-:,S. E@---4@Ci C,WEIGHT OF FULL FOOD JAP:@- 650GRFiMS RRTS WEEI<: 64 IF'045.76 OIS F.'FI#T I F!0 4 5'1"I- OIS FOOD JFLF.'IIS IF-.:C,457@S:EIS PFIT # . IS'045'.@"9 OIS FC,C,[.-jFiFI:IS IR045;:;O OIS F:FIT # IF,045.1i:iOIS F i-i--'c-i,j FiF.- I I _:., IR04582 OIL F'FIT 0. 14 IR04576 OIS 51.2. 6r@ 468. 9--- Cl. 05 015 4 7'-@:-.@9 4 @-'-9. 16 - Cl. r@l-71. IF'04580 OIL 485. '@'S 511. o--,4 Cl.I &--I IF'04582 015 1 0.14 11 1 0.05 1 11 1 -0. o@;@ 1 11 1 0.10 0. 14 NOT ON 512. 6 468. 96 0.05 NOT 014 473. 7s9 489. 16 -0. 03 NOT ON 485. 36 511. 64 0.1 NOT ON STUDY STUDY STUDT' STUDY IP04581. OIS T -H F JFIF,. IIS T Fl IR04584 eis TFI IR04585 OIS F'FIT # FOOC@JAR IIS IR@4586 015 IF'0458 l@ OIL F 1-C-t1i)JFiF,,IIS IF:0458C@ 015 PAT # IF:04589 OIS F'AT # FOODJAR 115 IR04590 OIS PAT # IR04591 OIS FOOL-JAR ilS IR04592 OiS IR04593 OIS FOODJRR IIS IP04594 OIS IR04595 OIS FC,C,E-JAF,, IIS, .. -14596 OIS @L..J45-c47 015 T Fi FOOE)JRR 115 IR0459* OIS IRC'4599 OIS FOODJAR liS IF:C,4600 OIS IP@4601 015 451.50 ' 0 490. ' 410.89 0 C4.lci IF'04585 OIS @@I tZ. P,72 4C,5.65 452. 08 E-4 -0. 1 C.'Ll IR04588 OIS - Cl.cici IR045e9 OIS -cs. 06 0.05 IR04590 015 401. 8f.-: 528.21 487.92 299.45 :,67.92 455.05 50 --@-45. 86 442.91 4@'5. 68 ci 7E, 8 8. 27 0. 4-S --@SL;.7'0 5CII. 5C, ' 0.12 " 1 0 11 0 1 0 1 0. to It 1 1 11 1 -0.10 " :1 -0.00 " 11 1 0.05 ' 1 11 1 1 11 1 1 11: 1 1 Ei It 1 1 It 1 1 451.5 490. 6E. 410.89 0.1 NOT ON -el66.2 405.65 452. 08 392. 64 -0.1 NOT ON 0 NOT ON -0.06 0.05 NOT 014 40:1. 86 528.31 487.92 399.45 367.92 455.05 396. 5 345. 86 442.91 425. 68 STUDY STUDY STUDY STUDY 378. 76 388. 27 3 0. 48 386.7 501. 5 0.12 1077 F'.HT FCICIE-iFIF..,IIS I P C,4P-r%i-ll015 IF:Cl4E.Cil CilS Fl--,C'E)JFIFI*I.S 1 F.Cl4 P-C-,.4 015 IF'C'46C'5 015 I il,JFlp 115 ImC'46k-@@16 OIS IF'r-4IE.Cl.- CIIS F:RT # F -JFIF,' 115 1F.C4'6ri C'1 PAT # IP04609 OIS FOCi[-JFiF,,115 IF:04610 015 F:FIT# IR04611 OIS FQODJRP IIS IR04612 015 IP0461Z OIS FOC,DJAR 115 IR04614 OiS IR04615 OiS FOOC@ JFIF' I IS IR04616 OIS IR04617 OIS FOOC:-.JAP. 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Cl.05 IR04E.76 02S 484.98 41--,'.64 -ci@ ci7 IF*04E,;-$ 02S IP046""9 02S IP046-80 025 FOCI[,.JFiP 125 IR0468i 025 IP04682 02S FOOC:-JFiF, 12S IP@4683 025 iRO4684 02S FOODJAR 12S IR046e5 02S IP04686 02S FOOE-JAR 125 IP04687 02S F-.'.RT# IP046-S'S 02S FOOL-JAR 125 IR04689 02S F.'FIT# IR@4690 02S FOCiD.jRP 12S IR04691 025 IP04694'@ 02S PAT # FOOE-.jFiF-.-.12S IR04p-:9Z 02S lR04p-z-q4 025 F 0 0 [ -J FiF-..I- Z,---@ 1R Oel 5 1-@c-'4 02S IF,046?6 025 FCIOL*-JFIP IR04697 02S IF'04698 02S FOCIE,.JRF,, 125 IR04699 02S RAT # iPO4f-OO 02S FOODJRR 125 IR04701 02S IP04702 02S FOODJFIR 12S IR.04703 02S IR04704 025 RAT # FOODJAP 12S IR04705 02S P'.FIT# IF'04706 02S 1 1707 03S FOCID-JRR I:S IP04708 OZS IPO,If@09 035 F t--Cf,C- J R F-- i3S IR047:10 02S IR04711 GZS Fri$-iTrA)rl.1-1.s 5 1 15 E.2 ci.28 Z-51. I -@* 4r-10.38" 445.58 422. 92 431.09 483.92 428. @4 611.8'8 4-:@2.85 405-96 0. 0 *'@:1 IR04687 02S 4 --1<. 92 5.-@2.. 98 -0.02 IR04689 02S -@9,4. 91 5 1'4;. 74 476.28 0.02 IR04692 02S 4 E.--<6.8 ---,@@9!. 65 4 -'5o. 79 442. 82 @-91. 61 404.71 442. 14 4--l.97 434.05 -0.06 IR04699 02S 418.07 529.80 419.:L5 6ird.91 416.41 506.73 0.04 IR04704 025 513.12 0. 06 " IR04705 02S 05 " -,.49.46 :, I- 23 4'E.5.57 395.72 407.25 3:12. 79 ' 447.08 ' 4:71-1 2.9 ' 0. cici 2 2 -0.05 i-@, 2 2 -0.07 2 2 12 2 212 2 2 :L2 2 2 12 2 0.02 2 12 2 -0.02 2 12 2 2 0.02 12 2 2 12 I,2 12 2 2 12 2 -0-06 2 12 2 2 12 2 2 0.04 12 2 0.06 3 3 13 3 3 1.3 3 3 NOT ON STUDY 512. 28 3'-t;-.5.E. -0.05 NOT ON STUDY 484.98 41--<.64 -0. L47 NOT ON STUDY 518. 15 620. 28 351. 13 400.38 445.58 422. 92 431.0-q 483.92 428.:<4 611.88 432.85 405.96 0.02 NOT ON 4 1. 92 532.98 -0.02 NOT ON 394.91 524.74 476.28 0. 02 NOT ON 46-7@:6.8 379. 65 495, 7? 442.82 291. 61 404.71 442.14 213.76 431.97 434.05 -0.06 NOT ON 418.07 529.8 419.15 610.91 416.41 508.73 0.04 NOT ON 533.12 0. C,L; NOT ON :196. 05 249.46 3 9 --@.2 3. 465.57 395.72 407.25 3:13. 79 447.08 42-1 25 STUDY STUDY STUDY STUDY STUDY STUDY 1086 IF:@1.1 0<5 IF'.047i-7.eas For-'[.JFiFi.-'-<S IF'.C'41-14 OZS IF'C'4"15 C4 S Fl-tQ[@.JFIR 1 5 Ir - Ei3S li.-4 f@17 0-75 FC,C,C@JFiF,. 17@ S FOODJAR I:is 9 04 4 Ct --07 45--@i.5'.i.' 12 402. 97 :-i @-,--,4. 9E. i 405. 98 1:,: 308. 41 459. 0,-; 3 421. 72 495. 16 4 p-.2.11 13 IR04720 035 IR04721 03S FOOE)JAR 135 IR04'722 025 IF*.04,@2Z 03S FOQDJRR 135 IR04.-24 02S IP04725 OZS FOOE-JFiF*. :I:IS IR04'.v2E 035 IR04727 035 FOOC@JAR IIS IR@4728 025 IF'04729 035 FOOD-JRR 13S IR04-1'30 03S 1R04731 FOODJRR 135 IR047'@7'2 025 IR04*.@"33 03S FOOI).JFiF..1,-7-:5 IF:04'.@'34 035 IF'047'@@-5 03S FCiOl-JRF., 12S IF:0477-.6 03S IR04'."7-.7OZS FOOD JAR 13S IP.':147--@:80:35 03S FOOD.JRR 135 IF'04740 03S IR04741 035 FQODJRR 13S IR04742 03S IR04743 03S FOODJAR 13S IP04744 03S F,'AT IP04745 03S FOOE.-JRR 12S IR04746 OaS I.PO4-1741- OSS r -,C,C,JFiR1'-zS - --'1I4-4-1c-0 -@S< IF'04i@49 FOOD-JAR IF:04750 IR04751 PAT # 13S 03S 07-:S FOODJAR 13S IR04752 03S 457.71 --9< 5. -q9 4.s4. 00 48--<.52 484. 34 414.56 --9@1. 12 55:?.16 :<8 @;,I. @_-i 4,-2;. :,97. 15 :@8, 2. --6< E-31.99 507. 30 3--<7.27 407.72 L; 85 27c@. 27 --7@ 1. --<--< 4 T-Cl. 05 4C'9. 58 6IL;. 32 41CI. 02 422. 9:1 430. 89 414.35 480.01 ' 364. 96 ' 408.04 ' 438.19 ' 571.59 ' 380.54 ' 0.00 IR04744 03S 355.66 517.41 472.94 416. 59 419. 1 589. 54 3 9 5k-4 '-:@72.94 527.62 0.07 iRO4751 03S 509.25 489.35 33 13 3 3 13 3 --< :13 3 3 :13 3 3 :13 3 3 :I:3 3 13 -Z 3 :1:, 3 3 13 .3 3 13 3 3 1.3 3 3 :13 3 3 13 2 3 3 3 13 3 3 13 3 0.00 0.07 J4 4C'I. 97 4 -1--.@. 5 E., 40@7. 97 --8@ 4. 96 4C'5. 98 @;C@' 8. 41 4 5'-:@.09 421. o-3 495. 16 4 P*-2-.. il 408.72 457.71 --,;.959.9 424 48:,.52 484. 34 4:14.56 29:1. 13 5!!,9.16 -@8 3. :1 492. 08 :-1!:74 , :15 382.36 631.99 507. 3 337.27 366.08 515.04 407.7:< oc0 ::.85 :,72. 27 271. 33 450.05 0.00 520.98 NOT ON 409. 5'@O 616. 32 410. 02 422. 91 430. 89 414.35 480.01. 3L;4. 9fE 408.04 438.19 571.59 3L:kO.54 0 NOT ON 355.66 .517. 41 472.94 416. 59 419. 16 589.54 393.5 372.94 527.62 0.07 NOT ON 509.25 489.35 STUDY STUDY STUDY .1087 IR04753 035 FOOE)JAR 135 iRO4754 03S iRO4755 03S FOODJAR 135 9999999999 349.95 ' 3 417.32 ' 13 406.14 ' 3 441.18 ' 3 414.84 ' 13 99 0 349.95 417.32 406.14 441.18 414.84 1088 TWO YEAR ORAL(DIET) TOX-Ot4C STUDY OF FM-3924 & FC-143 IN RATS EXF'.# 0281CROO12 TECHt4ICIAN INITIALS:S SW TODRY'S DRTE:S 8/26/82 SEX OF RATS:S FEMALE ROOM NUMBER:S D-340,D-338 WEIGHT OF FULL FOOD JAR:S 650GRAMS WEEK 68 IR04576 RAT TFI IR04577 FUODJRR IR04578 PAT # OIS OIS itS OIS -0.06 iRO4576 OIS 0 518.17 476.04 -0.07 IR04578 OiS 1 - -0.06 0 1 11 1 -0.07 IR04579 FOOE)JRR IR04580 RAT # IR04581 FOODJRR IR04582 RAT # IR045a3 FOQDJRR IP04584 IR04585 RAT # FOODJAR IP04586 IR04587 FOODJAR iR@4588 F,'FIT# IR04589 RAT # FOODJAR IR04590 PAT # IR04591 FOODJAR IR04592 IR04593 FOODJRR IR04594 IR04595 FOODJRR IR04596 IR04597 015 115 015 OIS its OIS OiS IIS eis OIS IIS OiS OIS iiS 015 OiS IIS OIS OIS 115 OIS OIS IIS OIS OIS IIS OiS OIS 482.84 ' 484.84 ' -0.03 IR04580 OIS 498.78 497.89 -0.06 IR04582 OIS 461.88 ' 505,43 ' 379.64 ' -0.06 ' IR04585 OIS 397.24 " 408.39 ' 444.47 ' 399.49 ' 0.03 ' iRO4588 OIS 0.08 IR04589 OIS -0.04 -0.10 IR04590 OiS 392.98 543.07 497.29 397.27 414.26 460.69 3L:kS.20 402.91 422.50 1 11 1 -0.03 1 it 1 -0.06 1 It 1 1 -0.06 it 1 1 11 1 0.03 1 0.08 11 1 -0.10 1 it 1 1 it 1 1 11 3. 1- -0.06 NOT ON STUDY 518.17 476.04 -0.07 NOT ON STUDY 482.84 484.84 -0.03 NOT ON 498.78 497.89 -0.06 NOT ON 461.88 505.43 379.64 -0.06 NOT ON 397.24 408.39 444.47 399.49 0.03 NOT ON 0.08 NOT ON -0.04 -0.1 NOT ON 392.98 543.07 497.29 397.27 414.26 460.69 388.2 .@402.9i 422.5 426.44 STUDY STUDY STUDY STUDY STUDY STUDY FOODJRR IR04598 IR04599 FOODJRR IR046ee IR04601 IIS OIS OIS IIS ots OIS 397.30 ll 360.37 1 334.91 ' -1 428.30 ' it 5e5.62 ' i 0.17 1 397.3 360.37 334.91 428.3 5e5.62 0.17 1089 RPT FOOE)JRR its IP04601 eis 504.64 0.1.11 NOT ON STUDY 504.64 iRO4602 OIS 382-76 , 1 382.76 IR04603 OIS 420.45 ' 1 420.45 FOODJRR IIS IR04604 OiS IR04605 OIS F-'ODJAR IIS 401.03 ' 11 449.54 " 1 370.63 ' 1 418.84 ' it 401-03 449.54 370.63 41e.84 - 34606 OIS 475.00 ' 1 475 IR04607 OIS 0.08 1 0.08 F'.AT # FOODJAR ILS IR04607 OIS 496.38 0.08 11 NOT ON STUDY 496.38 IR04608 015 0.00 NOT ON STUDY IR04609 OIS 411.52 1 411.52 FOODJAR IIS 514.57 11 514.57 IR04610 OIS 0.04 l@ 0.04 RAT # IR046iO OIS 0.04 NOT ON STUDY iRO4611 OIS 494.8:1 1 494.81 FOODJAR ilS 484.53 11 484.53 IR04612 015 400.98 1 400.98 IR@4613 OIS 477.22 1 477.22 FOODJAR IIS 398.63 11 398.63 IR04614 OiS 429.63 1 429.63 IR046i5 OiS 435.72 1 435.72 FOODJRR IIS 397.24 11 397.24 IP@4616 OIS 352.56 1 352.56 IR04617 OIS 383.30 1 383.3 FOODJRR iiS 440.27 11 440.27 IR04618 elS 429.24 1 429.24 IR04619 OIS 0.03 1 0.03 RAT IR046i9 OIS 0.03 NOT ON STUDY FOODJRR IIS 504.65 it 504.65 IR04620 OIS PAT # e.ei IR04620 OIS i 0.01 o.ei NOT ON STUDY iRO4621 OIS FOODJAR 115 350. 96 1 502.37 11 350.96 502.37 IR04622 OIS PAT # 0.05 IR04622 OIS :L 0.05 0.05 NOT ON STUDY IR04623 FOODJAR elS ilS 428.99 ' 1 518.95 ' 11 428.99 518.95 IR04624 015 407.75 ' 1 407.75 iRO4625 1 390.95 FOODJAR iRO4626 OIS IR04627 OiS 11 473.57 ' 1 473.32 ' 1 382.48 473.57 473.32 FOODJRR IIS 343.90 ' 11 343.9 IR04629 OIS 456.45 ' 1 456.45 IR04629 OIS RAT # 0.07 ' 1 IR04629 OIS 0.07 ' 0.07 NOT ON STUDY FOODJRR LIS 495.96 ' 11 495.86 IR04630 OIS 0.06 1 1 0.06 RAT # IR04630 OIS- 0.06 @ NOT ON STUDY IR04631 RAT # FOODJRR IR04632 R<FIT # OIS IIS OIS 0.07 ' 1 e. IR04631 OIS e2 ' -11 0.03 l@ IR04632 OLS 0.07 ' 0.03 0.07 NOT ON -0.02 0.03 NOT ON STUDY STUDY IR@4633 OIS 0.04 1 0.04 P'"'T# IR04633 015 0.04 NOT ON STUDY I JDJAR IIS 0.07 11 0.07 iRO4634 elS iRO4635 OIS 341.87 1 432.15 1 341.87 432.15 FOODJAR IIS IR04636 OIS 400.45 11 408.27 1 400.45 408.27 IR04637 OIS FC,GDJFIR iiS 399.55 1 424.31 it 399.55 424.31 - 1090 IP04638 015 IR04639 OIS RAY # FOODJAR ilS IR04640 OIS RAT # IR04641 025 -14642 e2S FOODJAR 12S T Fi IP04643 02S iRO4644 02S FOODJAR 12S IR04645 025 TR IR04646 02S TA FOODJAR 12S IR04647 025 IR04648 025 TH FOODJAR 12S TFI IR04649 02S iPO4650 02S FC,ODJRR 12S IR04651 02S iRO4652 02S RFIT * FOODJAR 12S iRO4653 02S IR04654 02S RAT # FOODJAR 12S IR04655 02S RAT # IR04656 025 RAT # FOODJRR 12S IR04657 02S IR0465e e2s FOODJAR 12S IR04659 025 IR04660 02S FOODJRR 12S IR04661 02S IR04662 02S FOODJAR 125 iRO4663 02S IR04664 02S RAT # FOODJAR 12S lRe4665 02S IR04666 02S RAT # FOODJRR 12S IR04667 025 IR04668 02S r IDJAR 12S 1.,%:44669 e2s F'ST # IR04670 e2S FOODJAR 12S iRO4671 02S RAT # IR04672 02S 523.05 0. 02 IR04639 OIS 496.13 0.18 IR04640 OIS 441.31 ' 487.59 ' 0 369.93 ' 473.:10 ' 427.12 ' 4--@3.73 ' 0 415.ird ' 0 376.61 ' 440.83 ' 317.94 ' 0 412.54 ' 0 363. 71 ' 522.59 ' 270.58 ' 333.81 ' 0.09 IR04652 02S 473.29 495.86 0.02 IR04654 02S 504.75 -0.00 IP04655 02S -0.02 IR04656 02S 0.00 381.17 :,66.79 444.36 474.43 38Lq.95 400.05 394.97 375.76 425.55 413.63 0.05 IR04664 02S 563.69 395.37 0.05 IR04666 02S 514.76 332.15 471.11 452.00 -0.05 iRO4669 02S 501.57 515.62 -0.03 IR04671 02S 396.72 1 5c@-3-05 1 Cl.02 0.02 NOT ON STUDY li 496.13 1 o.ie e_is NOT ON STUDY 2 441.31 2 0.00 NOT ON STUDY 12 487.59 0 2 369.93 2 473.1 12 427.12 2 433.73 0 2- 415.18 0 12 376.61 2 440.e3 2 317.94 0 12 412.54 0 2 363.71 2 522.59 12 370.58 2 333.81 2 0.09 0.09 NOT ON STUDY :L2 473.29 2 495.86 2 0.02 0.02 NOT ON STUDY 12 504.75 2 0 -0.00 NOT ON STUDY 2 -0.02 -0.02 NOT ON STUDY 12 0 2 381.17 2 366.79 12 444.36 2 474.43 2 388.95 L2 400.05 2 394.97 2 375.76 12 425.55 2 4:L3.63 2 0.05 0.05 ' NOT ON STUDY 12 563.69 2 395.37 2 0.05 0.05 ' NOT ON STUDY "12 -514.76 2- 332.15 2 471.li 12 452 2 -0.05 -0.05 ' NOT ON STUDY 2 501.57 12 5:15.62 2 -0.03 -0.03 ' NOT ON STUDY 2 396.72 1091 FOODJAR IR046'.73 025 IR04674 025 RAT * FOOE)JAR 12S IR04675 02S IR04676 02S P*'T # . JDJRR 12S IR04677 02S IR04678 02S PAT # FOODJAR 12S IR04679 02S IR04680 025 FOODJAR 12S IR04681 02S IR04682 02S FOOD-JAR 12S IR04683 025 IR04684 02S FOODJAR 12S 1R04685 IR04686 FOODJAR IR@4687 RAT # iRO4688 FOODJAR IR04689 RAT # IP04690 FOODJAR IR@4691 IR04692 RAT FOODJAR iRO4693 iRO4694 FOODJAR IR04695 IR04696 FOODJAR IR04697 IR04698 FOODJAR IP04699 RAT # IR0470e FOODJAR IR04701 IR04702 FOODJAR IP04703 IR04704 RAT # FOODJRR iRO4705 F,'RT # 4"04706 34707 FOODJAR IR04708 IP04709 FOODJAR 025 125 02S 02S 12S 02S 02S 12S 025 025 12S 02S 02S 12S 025 025 12S 02S 02S 12S 02S 02S 12S 02S 02S 12S 02S 02S 12S 02S 035 03S 13S 035 03S 135 530-43 521.37 - -0-05 iRO4674 e2S 504.56 , 366.51 -0-03 IR04676 02S 522.02 413.72 -e.o6 iRO4678 02S 49e..66 515.51 618.86 351.03 402.00 412.83 454.93 406.70 498.91 426.76 ze:l.87 -0.08 IR04687 02S 427.49 ' 524.15 ' -0.09 IR04689 02S 392.13 519.84 466.82 -0.06 IR04692 02S 452.03 375.28 495.27 446.49 397.83 418.15 316.88 440.65 409.70 -0-00 iRO4699 02S 421.17 ' , 517.48 ' 403.7e 614.29 ' 407.53 ' 48:L.06 ' 0.10 IR04704 02S 545.16 0.09 IR04705 02S 3E;2.02 352.50 437.26 478.88 402.20 396.22 12 2 2 -0-05 12 2 2 -0.03 12 2 2 -0.06 12 2 2 12 22 :L2 2 2 12 2 2 12 2 -0.08 2 12 2 -0.09 2 12 2 2 -e.06 12 2 2 12 2 2 12 2 2 12 2 -0.00 2 12 2 2 12 2 2 e.io 12 2 0.09 3 3 13 3 3 13 Z30. 48 521.37 -0.05 NOT ON 504.56 366.51 -rd.03 NOT ON 522.02 413.72 -0.06 NOT ON 498.66 515-51 618.86 351-03 402 412.83 454.93 406.7 488.91 423.07 STUDY STUDY STUDY 635.37 426.76 381.87 -0.08 NOT ON 427.49 524.15 -0.09 NOT ON 392.13 519.84 466.82 -0.06 NOT ON 452.03 375.28 495.27 446.49 397.e3 409.57 418.15 316.88 440.65 409.7 0 NOT ON 421.17 517.48 403.7 614.29 407.53 481.06 .0.1 NOT ON 545.16 0.09 NOT ON 382.02 352.5 437.26 478.88 402.2 396.22 STUDY STUDY STUDY STUDY STUDY STUDY 1092 iRO4710 035 IR04711 03S FOODJAR 13S IR04712 03S IRb4713 03S FOODJAR 13S iRO47i4 03S IR04715 03S FQOE,JRR i3S 34716 03S @L,,047i7 03S FOODJRR 13S IR047i8 03S IR04719 e3S FOODJRR i3S IR04720 03S iRO4721 03S FOODJRR 13S IR04722 035 IR04723 03S FOODJAR 13S IR04724 03S iRG4725 035 FOCDJAR 135 IR04726 03S IR04727 03S FOODJAR 13S IR04728 03S IR04729 03S FOODJAR 13S iRO4730 03S IR04731 03S TA FOODJRR 13S iRO4732 03S IR04733 03S FOODJAR 13S IR04734 035 IR04735 03S RAT # FOODJRR 13S TFI IR04736 035 IR04737 03S FOODJRR 13S IR04738 03S iRG4739 03S FOODJAR 13S IR04740 03S IR04741 03S FOODJRR 13S IR04742 03S IR04743 03S FOODJAR 13S IR04744 03S RAT # iRO4745 03S FOODJAR 13S IR04746 03S IR04747 03S r IDJAR 13S 1,,..04748 03S iRO4749 03S FOODJRR 13S iRO4750 03S iRO4751 03S RAT 321.92 ' 449.25 ' 435.25 ' 388.75 ' 4es.29 ' 426.41 ' 396-12 ' 381.77 ' 412.82 ' 314.86 ' 474. 38 " 424.55 " 484.58 ' 457.25 ' 386.08 479.65 393.37 404.30 495.49 488.69 374.38 373.19 569.04 399.40 490.11 394.87 386.07 615.48 499.92 382.25 376.45 519.76 0 386.40 589.73 ' 375.00 ' 400.31 ' 430.23 ' 0.14 ' IR04735 03S 517.64 ' 0 391.06 603.06 441.07 427.55 443.53 404.63 374.66 468.68 408.22 440.98 571.79 368.93 -0.07 iRO4744 03S 355.62 513.49 470.59 415.77 417.55 581.38 392.22 379.51 51l.20 -0.11 IR04751 03S 3 3 1.3 3 3 13 3 3 13 3 3 :L3 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 0 13 3 3 13 3 3 0.14 13 0 3 3 13 3 3 13 3 3 13 3 3 13 3 -0.87 3 :L@ 3 3 13 3 3 13 3 3 -0.11 321.92 449.25 435-25 388.75 408-28 426.41 396.12 381.77 412.82 314.86 474. 38 424.55 484.58 457.25 386.08 479.65 393-37 404.3 495.49 4es.sg 374.38 373.19 569.04 399.4 490.11 394.87 386.07 615.48 499.92 382.25 376.45 5:L9.76 389.4 589.73 375 400.31 430.23 0.14 NOT ON 517.64 STUDY 391.06 603.06 441.07 427.55 443.53 404.63 374.66 468.68 408.22 440.98 571.79 368.93 -0.07 --NOT ON 355.62 513.49 470.59 415.77 417.55 581.38 392.22 379.51 511.2 -e.ii NOT ON STUDY STUDY 1093 FOODJRR 13S IR04752 03S iRO4753 03S FOODJRR 13S IR04754 03S IR04755 03S FOODJAR 13S 9999999999 502.53 ' 13 502.30 ' 3 349.61 ' 3 399.91 ' 13 409.75 ' 3 436.58 ' 3 407.94 ' 13 99 0 502.53 502.3 349.61 399.91 409.75 436.58 407.94 -1094 TWO YEAR OPRL<DIET) Tox-OtAC STUDY OF FM---@!?@'4& FC.-143 1?4 RATS TECHf4ICIAN INITIALS:S SW EXP.# 028:LCROO12 TODRY'S DRTE:S 9/9/82 SEX OF RATS:S FEMALE ROOM NUMBER:S D-340,D-338 WEIGHT OF FULL FOOD JAR:S 650GRAMS WEEK 70 IR04576 RAT # IF'04577 TFI FOC,DJAR IR04578 PAT # IR04579 FOODJAR IR04580 PAT # IR04581 TA OiS OiS IIS 015 OiS ilS 015 OIS -0.00 IR04576 015 519.54 0 473. 94 -0.05 IP04578 OiS 496.19 482.66 -0.15 IR04580 OIS 491.57 0 1 -0.00 10 11 1 -0.05 1 11 1 -e.15 1 0 0 NOT ON 519.54 STUDY 473.94 -0.05 NOT ON 496.19 482.66 -0.15 NOT ON 491.57 STUDY STUDY FOODJRR IR045e2 RAT # liS 015 IR04583 FOODJAR IR04584 IR04585 FOODJRR IR04586 IR04587 FOODJAR IF:04588 RAT # 015 IIS OIS OIS ilS OIS 015 115 OIS IR04589 F.'FIT# FOOE)JAR IR04590 RAT # IR04591 FOODJAR IR04592 iRO4593 FOODJAR IR04594 IR04595 FOODJAR OIS iiS OIS OiS itS OIS OiS IIS OIS OIS IIS iRO4596 OiS IR04597 015 FOODJRP IIS 04598 OIS :j.k@4599 OIS FOODJAR iiS IR04600 OIS IR04601 OIS RAT 0 FOODJRR IIS IR04602 OiS 516.09 0.03 iRO4582 OiS 460.77 ' 509.82 ' --<89.82 ' 396.89 400.55 453.25 383.90 0.07 IR04588 OIS 0.08 IR04589 OLS 0.03 0.05 IR04590 OIS 403.41 513.99 493.63 386.37 403.80 461.70 371.88 375.80 397.99 ' 439.93 ' 400.45 ' --<60.66 :,:421.3 4:Li.99 511.63 -0.04 iRO4601 OIS 494.98 ' 386.56 ' 11 1 0.03 1 it 1 1 11 1 1 11 1 0.07 ' 1 0.08 " 11 1 e.e5 ' 1 li 1 1 11 1 1 11 -1 1 :Li 1 1 I:L :L :L -0.04 11 1. 516.09 0.03 NOT ON 460.77 509.82 389.82 0.00 396.89 400.55 453.25 383.9 0.07 NOT ON 0.08 NOT ON 0.03 O.e5 NOT ON 403.41 513.99 493.63 386.37 403.9 461.7 371.88 375.8 .-397.99 439.93 4eO.45 360.66 342. 13 4:li.99 511.63 -0.04 NOT ON 494.98 386.56 STUDY NOT ON STUDY STUDY STUDY STUDY STUDY -1095 IF:0460--@ OIS FOOD.JFiF., I.IS IR04604 015 IR04605 FOOC)JAR IR04606 OIS IIS OIS iRO4607 OIS r'9T # @OE)JRR IP04608 PAT # ilS OIS IP04609 OiS FOODJAR 115 IF'04610 015 PAT # IR046il FODDJAR IR046i2 IRD4613 FOODJAR IR046i4 1R04615 FOODJRF' IR04916 IP04617 FOCID-JAP iF'046i8 IR04619 PAT # FOODJAR IR04620 PAT # 015 IIS OIS OIS ilS 015 115 OIS OIS 115 OIS OiS IIS OiS IP04621 FOOC:-JFIR IR04622 PAT # IR04622 FOOL@JriF, IR04624 IR04625 FOOL-.JFIP IR04626 IR04627 FOODJAR iRO4628 iRO4629 RAT # FOODJAR iRO4630 RAT # iRO4631 RAT # FOODJRR iRO4632 RAT # OIS liS 015 015 IIS 015 015 115 OIS OIS IIS OIS OIS IIS OIS OiS liS OIS IR04633 OIS RAT # FOODJAR IIS lPq4634 OIS 1 4625 OIS FOODJAR IIS IR04636 015 iRO4637 OIS FOODJAR IIS iRO4638 OIS IR04639 OIS 421. :r,-% 411. 95 454. 05 379.94 383-22 515.43 ' -0-02 ' IR04607 OIS 490. 51D -0.05 IR04608 015 417.13 t-32. 04 -0. 08 iRO4610 OIS 464.36 ' 5--).31.9 ' 410.33 ' 487.85 ' 362.41 390.4F@ ' --<55.63 ' 388. el 416.95 4-3.64 0.10 IR046i9 OiS 513.15 -0. 02 iRO4620 OiS 361.:12 ' 486.87 ' -0.04 IR04622 OIS 437.37 499. t56 410.97 403.92 356.60 470.22 481.57 340.30 459.94 -0.03 IR04629 OIS 493.36 ' -0.05 ' IR04630 OIS -0.03 ' IR04631 OIS -ee.7 -0.04 IR04632 OiS -0.02 IR04633 OIS -0.03 353.20 442.45 379.71 410.49 401.24 4Ci9.32 544.18 0.00 1 1:1 1 1 11 1 1 -0.02 11 1 -0@05 1 li :L -0.08 1 ii 1 1 li 1 1 :li 1 1 it 1 1 e.:Lo :L:L :1 -0.02 1 11 1 -0:04 1 :li 1 1 li 1 1 11 1 1 -0.03 ' 11 I -0.05 ' 1 -0.03 ' 11 1 -0.04 ' 1 - -0.02 ' 11 1 1 li 1 1 11 1 421. 411. 65 454. 01-0 379.94 383.22 515.43 -0.02 NOT ON 490.5 -0.05 NOT ON 417.13 532.04 -0.08 NOT ON 464.36 533.19 410.33 487.85 362.41 438.65 440.27 390.46 355.63 388. Esi 416.95 433.64 e.i NOT ON 513.15 -0.02 NOT ON 361.12 486.87 -0.04 NOT ON 437.37 499.66 410.87 403.92 356.6 470.22 4el.57 340.3 459-94 -0.03 NOT ON 493.36 -O.L-45 NOT ON -0.03 NOT ON -0. 07 -0.04 NOT ON -1&.02 NOT ON -0.03 353.2 442.45 379.71 410.49 401.24 409.32 544.iS 0 STUDY STUDY STUDY STUDY STUDY STUDY STUDY STUDY STUDY STUDY STUDY -1096 RAT FOOL-JAR IR04640 PAT # IIS OIS IR@4641 02S IR@4642 02S PAT # F [)JAR 12S lho4642 025 IR04644 025 FOODJRP 12S iRO4645 02S IP04646 025 FOODJAR 12S iRO4647 02S IR04648 025 FOODJAR 12S IR04649 02S IP04650 02S FOODJFIR 12S IR04651 02S IR04652 02S RAT # FOOD-JAR 1*-15 iRO4653 02S IR@4654 025 R.FIT # FOODJRR 12S IR04655 025 PAT # IR04656 PAT # FOODJAR IR04657 IR04658 FOODJAR IR04659 IR04660 FOODJAR IR04661 IR04662 FOOC).JAP IF*04663 IP04664 PAT # FOODJAR iRO4665 iRO4666 RAT # FUODJAR IR04667 iRO4668 FOODJRR iR@4669 PAT # IR04670 FOODJRR IR04671 'T # LLR04672 FOODJAR IR04673 iRO4674 RAT # FOODJRR iRO4675 025 12S 025 02S 12S 025 02S 12S 0'-'S 02S 125 02S 02S 12S 02S 025 12S 02S 02S 12S 02S 02S 125 02S 02S 125 02S 02S 12S 02S IR04929 Ois 4 9 4-@*.01 -cl-EI2 IR04640 OIS 408.9C, -0-04 IR04642 025 46*-:42.9 370.67 466.06 410. 9 @--:. 429.38 410.73 :@:97.41 ' 443.77 ' 216.05 400.04 364.06 514.08 36ci.19 ;-,26.72 -0.0--< IR04652 02S 492.58 ' 497.24 ' -0. 02 IR04654 025 534.89 0.06 IR04655 02S -0.04 IR04656 02S -0.04 386.00 :,P:-3-. 76 416.21 482.61 389.62 387.58 7-@85.35 371.80 418.77 --197.45 0.20 IR04664 02S 564.37 ' 387.49 ' -0.00 IR04666 02S 527.91 330.34 454.08 422.01 0.14 IR04669 02S 489.97 ' 522.99 ' 0.06 IR04671 025 :@97.76 536.73 513.89 0.02 IR04674 02S 502.07 356.69 0.00 -0-02 2 2 -0.04 12 2 2 :12 2 2 12 2 2 12 2 2 12 2 2 -0.03 12 2 2 -0.02 12 2 0.06 2 -e.04 1.2 2 2 12 2 2 12 2 2 12 2 2 0.20 12 2 2 -e.oo 12 2 2 L2 2 0.14 .2 12 2 0.06 2 12 2 2 0.02 12 2 NOT ON STUDY 4-q2. 01 -0.02 NOT ON STUDY 408.96 -0.04 NOT ON STUDY 469.29 370.67 466.06 4:10.9e 4'-19.38 410.73 397.41 443.77 316.05 400.04 264.06 514.08 360.19 326.72 -0.03 NOT ON STUDY 492.58 497.24 -0.02 NOT ON STUDY 534.es 0.06 NOT ON STUDY -0.04 NOT ON STUDY -0.04 386 363.76 416.21 482.61 389.62 387.58 385.35 371.8 418.77 397.45 0.2 NOT ON STUDY 564.37 387.49 0 NOT ON STUDY 527.91 330.34 454.08 422.01 0.14 NOT ON STUDY -489.97 522.99 0.06 NOT ON STUDY 397.76 536.73 513.89 0.02 NOT ON 502.07 356.69 STUDY 1097 IF-04676 02S PAT # FOOE)JFIP 12S iRO4677 02S IP@4678 02S RAT # FOOE)JRR 12S -or!04679 02S 04680 02S FOO* DJHR i2s IP04681 02S iRO4682 02S FQODJAR 12S IF'04683 025 IR04684 02S FOOI@,JAP 12S iRO4685 025 IR04686 02S FOOE)JAR 12S iRO4687 02S PAT IP04688 02S FOOE)JRR 12S IF'04689 025 FE.FI#T IR04690 02S FOODJAR 12S IR04691 02S IR@4692 02S PAT # FOODJAR 12S IR04693 02S iRO4694 02S FOODJAR 12S IR@4695 02S IR04696 02S FOOD-JAR 12S IR04697 02S iRO4698 02S FOODJRR 12S IR04699 02S PAT # iPO4700 025 FOODJAR 12S IR04701 02S IR04702 02S FOODJAR 12S IR04703 02S IR04704 02S RAT # FOODJFFR 12S IR04705 02S RAT # IR04706 03S IP04707 e3S FQODJRR i3S IR04f-08 03S IR04709 03S FOODJAR 13S 1 4710 03S IP04711 03S FOODJRR 13S IR04712 03S IR04713 03S FOODJAR 13S IR04714 03S 0 04 IRC,46.-6 02S 53C,. 34 394.74 0. 0--< IR04678 02S 531-10 521.50 626. 2f137.14 47-'5.11 391.87 400.54 398.76 489.18 395.44 629.08 421.07 30 -0.04 IR04687 02S 439.45 ' 508.06 ' -0.06 IR04689 02S 401.70 5rJ5.8i 485.33 -0.05 IR04692 02S 433.80 380.32 478.92 406.65 387.75 397.35 4c-@S.86 309.51 439.97 3-q9.81 1.41 IR04699 02S 408.67 516.14 400.81 621.01 381.97 462.91 0.04 ' IR04704 02S 535.62 ' 0.05 ' iRO4705 02S. 366.11 348.12 420.14 466.90 405.10 382.37 320.94 460.45 407.30 374.04 407.73 415.25 386.48 2 o@ 04 0. 04 NOT ON STUDY 12 530. 34 2 2'-;4.74 2 o.e:i 12 2 2 12 El.0 -i NOT ON 531.1 521.5 626.27 337.14 STUDY 2 425.li 2 391.87 12 400.54 2 398.76 2 489.18 :12 395.44 z 629.08 2 421.07 12 276.3 2 -0.04 -e.e4 NOT ON STUDY 2 439.45 12 508.06 2 -0.06 -0.06 NOT ON STUDY 2 40:1.7 12 5e5.ei 2 485.33 2 -e.05 12 -0.05 NOT ON 433.8 STUDY 2 390.32 2 478.92 12 406.65 2 387.75 2 397.35 12 428.P,6 2 309.51 2 439.97 12 399.ei 2 1.41 1.41 2 NOT ON STUDY 408.67 12 516.14 2 400.81 2 621.01 :L2 381.97 2 462.91 2 0.04 0.04 ' NOT ON STUDY 12 535.62 2 0.05 0.05 ' NOT ON STUDY 3 366.il 3 348.:L2 -t3 --420.14 3- 466.9 3 405.1 13 382.37 3 320.94 3 460.45 13 407.3 3 374.04 3 407.73 13 415.25 3 386.48 1098 IR04715 035 FOOE)JAR 125 IF'04716 03S IR04717 035 FOODJAR 135 IR04718 03S IR04719 035 F DJAR 13S IK04720 01-:S IP@4721 02S FOODJAR IZS IR04722 OSS IR04723 03S FOOD.JRP 13S IR04724 03S IR04725 03S FOODJAR 13S IR04726 03S IR04727 03S FOODJFTR 135 iRO4728 03S IR04729 03S FOOE) JFIR 13S iRO4730 03S IR04f-31 03S FOOE)JAR 13S IP04732 OZS IR047@-'3 01-:S FOODJAR 13S IR04734 OZS IR04735 03S RFIT # FOODJAR 13S IR04736 035 IR04737 03S FOODJAR 13S IR04 l@'38 03S IR04739 03S FOOE)JAR 135 IP04740 03S IF:04741 025 FOODJRR 135 IR04742 03S IR04743 035 FOODJRR 13S IR04744 03S PAT # iR@4745 03S FOODJAR 13S IR04746 03S iRO4747 03S FOODJRR 13S IR04749 e3S IR04749 03S FOODJRR 13S IR04750 03S IR04751 03S R.FIT # ,ODJRR 13S ip;'04752 03S IR04753 03S FOODJAR 13S IR@4754 OZS IR04755 03S FOODJRR i3S 9999999999 381. 71 412.26 :-es. E>l9 466.85 412.11 488.88 447.32 390.10 461.85 3e7.23 411.85 494.13 484.15 413.49 366.33 573.45 386.11 512.30 391.91 372.76 ' 614.49 ' 513.93 ' 25E.. 01 368. 59 522.31 392. 78 593.87 374.16 379.29 451.29 -0.04 iRO4735 035 517.28 ' 380.79 ' 5.97.75 ' 425.14 " 432.41 ' 424.ei , 38L;.92 ' 466.64 ' 355.16 ' 416.16 ' 450.73 ' 592.37 ' 373.64 ' -0.03 IR04744 03S 346.89 509.31 457.95 411.43 406.34 573.06 392.63 405.09 507.98 ' 0.05 ' IR04751 03S 515.63 ' 510. --0! ' 354.36 384.07 412.81 435.72 372.06 99 3 1:1 3 3 13 3 3 13 3 3 13 3 3 13 3 313 3 3 13 3 3 13 3 3 13 3 3 13 3 3 -0.04 13 3 3 13 3 3 13 3 3 13 3 3 13 3 -0.03 3 13 3 3 13 3 3 13 -3 3- 0.05 13 3 3 13 3 3 13 0 3ei. ?i 412-26 308. 89 466.85 412.11 488.88 447.32 390.1 461.85 3:@'-.7.23 411.85 494.13 484.15 413.49 366.33 573.45 386.li 512.3 391.91 372.76 614.49 513.93 356.01 368.59 522.31 392.78 593.87 374.16 379.29 451.29 -0.04 NOT ON STUDY 517.28 380.79 597.75 425.14 432.41 424.81 386.92 466.64 355.16 416.16 450.73 592.37 373.64 -0.03 NOT ON STUDY 346.89 509.31 457.95 411.43 406.34 573.06 392.63 405.09 507.99 0.05 NOT ON STUDY 515.63 510. 3 354.36 384.07 412.81 435.72 372.06 -1099 T140 YEAR ORAL(DIET) TOX-ONC STUDY OF Fli-7-"-@24& FC.-143 IN EXF'.# 0281CROO12 TECHNIC:IAN INITIALS:S LJS&SW TODAY"S DATE:S 9/23,182 SEX OF RATS:S FEMALE ROOM NUMBEP:S D-340,D-338 WEIGHT OF FULL FOOR@ JRR.S 650GRFIMS PATS WEEK 72 IR04576 OIS PAT # IP04577 OIS FOODJAR IIS iRO4578 015 IR04579 OIS FOODJAR IIS IP04580 OIS PAT TFi IR04581 015 -0.03 IR04576 OiS 474.62 495.84 486.98 -0.11 IR04580 OIS 0 494.71 :1 -0.03 1- 11 1 1 11 1 -0.11 0 1 -0.03 NOT ON 541.60 STUDY 474.62 0.00 495.84 486.98 -0.11 NOT ON NOT ON STUDY STUDY 494.71 FOODJRR IR04582 RAT # IR04583 FOODJRR IR04584 IR04585 RAT FOODJAR TFI IR04586 IR04587 FOODJAR TFi IR04588 PAT # IR04589 RAT # FOODJRR iPO4590 RAT # IR04591 FOODJAR iRO4592 IR04593 FOODJAR TA IR04594 iRO4595 FOODJAR '04596 -.,04597 FOODJRR IR04598 iF*04599 FOODJAR IR04600 IIS OIS OIS IIS OIS 015 115 OIS OiS ilS 015 015 IIS OIS OIS liS OIS OIS IIS eis OIS IIS 015 015 itS OIS OIS iiS OIS 505.95 0.02 IR04582 OIS 477.17 507.98 :<41.68 0.92 IR04585 OIS 502.52 ' 0 406.54 ' 470.40 ' 382.21 ' 0 0.00 IR04588 OIS -0.02 IR04589 015 0.02 ' -e.e2' IR04590 OiS 415.03 ' 513.99 ' 502.23 ' 410.00 ' 384.19 0 462.81 393.83 351.27 360.41 ' 437.05 ' 411.32 ' 265.02 ' 350.86 ' 503.71 it 1 0.02 1 11 1 1 0..92 11 0 1 1 It 0 0.00 -0.02 It 1 -0.02 1 11 1 1 1:1 0 1 1 11 1 1 11 1 1 It 1 505.95 0.02 NOT ON 477.17 507.98 341.68 0.92 NOT ON 502.52 STUDY STUDY 406.54 470.4 382.21 0 NOT ON -0.02 NOT ON 0.02 -0.02 NOT ON 415.03 513.99 502.23 410 384. 19 STUDY STUDY STUDY ..462.81 393.83 351.27 360.41 437.05 411.32 365.02 350.86 396.iS 503.71. 1 100 PAT FOOC.,JRR IR@4602 IR04603 FOC,DJAR IR04604 TFI r,04605 .ODJAR IR0460E IR04607 RAT # FOODJAR IR04608 RAT # IR04609 FOODJAR IR04610 RAT # IR04611 FOOC,JRR 115 OIS 01$ IIS OIS GiS iis 015 015 ilS OIS OIS 115 015 OIS iiS IR04601 015 5(34, 20 398.76 425.97 401.98 460.55 367.77 389. 71 507.63 -ia.03 IR04607 OIS 4-c47.44 0.01 iRO4608 OIS 427.23 501.02 -0.02 . IR04610 OIS 472.79 ' 502.99 ' =0.01 11 1 1 11 1 0 1 li 1 1 -0.03 li 1 0.01 11 1 -0.02 1 11 NOT ON 504.2 398.76 425.97 401.98 460-55 STUDY 367.77 389.71 507.63 -0.03 NOT ON 497.44 0.01 NOT ON 427.23 50:1.02 -0.02 NOT ON 472.79 502.99 STUDY STUDY STUDY IP04612 OIS iRO4612 OiS FOODJRR IIS IR04614 IR04615 FOODJRR IR@4616 IR04617 FOODJAR IR04618 iRO4619 PAT # FOODJRP IP04620 RRT # IR04621 FOODJRF: IR04622 RAT # IR04623 FOOI)JRR IR04624 IR04625 FOODJRR IR04626 iRO4627 FOODJAR IR04628 IR04629 RAT # FOODJRR IR04630 RAT # IR04631 PAT # OIS IIS OiS OIS liS OiS OIS 115 OIS 015 IIS OIS 015 IIS OIS OiS IIS OIS OIS IIS OIS OIS IIS OiS OIS FOODJAR iiS Inc)4632 OiS IR04633 OIS RAT 413.04 " 486.34 ' 440.07 ' 294.:L2 ' @ '->55.20 ' 388.35 ' 419.19 ' 456.27 ' -0.09 IR04619 OiS 509.59 -0.09 iRO4620 OIS --,,64.41 499.32 -0.07 IR04622 OIS 428.Ord ' 496.00 ' 413.51 ' 387.43 ' 376.09 ' 48:1.86 483.01 364.58 475.09 0.09 IR04629 OIS 496.29 ' 0. 13 ' IR04630 015 0.02 ' iRO463i OIS 0.08 0.02 IR04632 OIS 0.01 IR04633 015 1 413.04 1 486.34 390.39 442.03 :L 440.07 :li 394.12 1 355.2 1 388.35 it 419.19 1 456.27 1 -0.09 -0.09 NOT ON STUDY 11 509.59 1 -0.09 -0.09 NOT ON STUDY 1 364.41 it 499.32 1 -0.07 -0.07 NOT ON STUDY 1 429-08 11 496 1 413.51 1 387.43 li 376.09 481.86 1 483.01 11 364.58 1 475.09 1 0.09 O.OQ --NOT ON STUDY -11 496.29 1- 0.13 0.13 NOT ON STUDY 1 0.02 0.02 ' NOT ON STUDY 11 0.08 1 0.02 0.02 ' NOT ON STUDY 1 0.01 0.01 ' NOT ON STUDY 1 101 FOODJRP IIS IP:04634 OIS IR04635 OIS FOOD-JAR liS IR04626 015 IR04637 OIS FOOD JAR IIS IR@4638 015 IF'04639 OiS PAT # FOOD-JAP IIS J' -1464LI OIS TF1 -0 02 ' 350. 8:1 , 449.83 370.88 423.14 415.15 409.93 571.18 0. rd3 IR04639 OIS 482.23 -0.01 1 IR04640 GIS 0 :L:i 1 1 li 1 1 :li 1 1 11 1 0 0.03 -0.01 -0.02 350.81 449.83 370.88 423.14 415.15 409.93 571.iS 0.03 NOT ON 4,02.23 -e. 01 NOT ON STUDY STUDY IR04641 025 436.58 2 436.58 TA 0 0 IR04642 02S 0.02 2 0.02 RRT # . IR04642 02S 0.02 NOT ON STUDY FOODJRR 12S 428.53 12 428.53 IR04643 02S 3.77. 38 2 377.38 IR04644 02S 46-1.74 2 461.74 FOODJFIF.' "2S 418.94 0 418.94 IR04645 02S 442.74 2 442.74 IR04646 02S 414.56 2 414.58 FO,DD-JAR 12S 388. 77 :12 388. 77 IF!04647 02S 447.:17 2 447.17 IR04648 O'@'S 315.30 2 315.3 FOOD-JAR 12S 397.49 :L2 397.49 IR04649 025 370.11 2 370.il IR04650 025 524.33 2 524.33 F -*O[)JAR 12S 3@-4. 48 12 354.48 IR04651 02S 240.07 2 340.07 IR04652 025 0.04 2 0.04 F'FIT # IR04652 025 0. 04 NOT ON STUDY FOODJAP! 12S 467.98 ' 12 467.98 iRO4653 025 500.71 ' 2 500.71 IR04654 025 0.07 ' 2 0.07 F.'FIT# IR04654 02S 0.07 NOT ON STUDY FOOE)JAR 125 481.77 ' 12 48:L.77 IR04655 02S PAT # G.ID5 ' 2 IR04655 02S 0.05 " 0.05 NOT ON STUDY IR@4656 025 0.02 2 0.02 RAT # iPO4656 02S 0.02 ' NOT ON STUDY FOOE)JAR 12S 0.05 :L2 LA.05 IR04657 02S 388.07 2 388.07 IR04658 025 379.74 2 379.74 FOODJRR 12S 404.97 12 404.97 IR04659 02S 482.78 2 482.78 IR0466o e2S 401.06 2 40:1.06 FDODJAR 12S 384.65 12 384.65 IR04661 02S 387.51 2 387.51 IR04662 02S 385.11 2 385.11 FOODJAR 12S 384.44 :12 384.44 IF*04663 02S 390.28 2 '390.28 IR04664 02S 0.08 2- 0.08 F.'AT # IR04664 02S 0.08 NOT ON STUDY FOODJAR 125 551.39 ' 12 551.39 IR04665 02S 396.30 ' 2 396.3 IR04666 02S PAT # 0.05 ' 2 IR04666 02S 0.05 0.05 NOT ON STUDY -,O[)JRR 12S 524.68 ' 12 524.68 -.,04667 02S 318.8.9 ' 2 318.89 IR04668 02S 2 470.57 1 102 FOODJAR IR04669 PAT # IP04670 FOOE)JAR IR04671 PAT # IR04672 i2S 02S 025 i'-S" 02S 02S 375. 80 ' 12 0.06 " 2 IR04669 02S 490.36 " 2 508. 58 " 12 -0.04 ' 2 O.OE. IR04671 e2S -0.04 2 --,:758. 06 NOT ON 490.36 50e..58 -0.04 NOT ON 403.96 STUDY STUDY f-110[)JAR12S .04673 02S IR04674 025 PAT # FOODJAR i2S IF'04675 02S iPO4676 02S PAT # FOODJAP iP@4677 IR@4678 PAT # 1.2S 025 02S FOODJAR IP04679 IR046eO FOODJAR IR04681 IR04682 FOODJAR IP04683 IR04684 FOODJRR IR04685 IR04686 FOODJAR iRO4687 PAT # IR04688 FOODJAR IR04689 PAT # IR04690 FOODJAR IR0469i IR04692 PAT # FOODJAR IR04693 IR04694 FOODJRR IR04695 IR04696 FOODJAR IP04697 IR04698 FOODJAR IP@4699 PAT # 12S 025 02S 12S 02S 02S 12S 02S 02S 125 02S 02S 12S 02S 02S 12S 02S 02S 125 02S 02S 12S e2S 02S 12S 02S 02S 12S 02S 02S 12S 02S IP@4700 02S FOODJAR 12S IR04701 025 J@94702 02S F IDJAR 12S 5:10. 28 ' :L2 51o-;.03 ' 2 0.09 2 IR04674 02S 0.09 507.74 12 35:L. 95 2 -0.02 2 IR04676 e2S -0.03 485.04 12 298.06 2 -0.06 2 IR04678 02S -0.06 5C,5.98 12 516.49 2 628.71 2 332.79 12 417.03 2 394.63 2 405.77 12 389.69 2 484.94 2 -f98.23 12 657.83 ' 2 420.31 ' 2 335.25 ' 12 -e.io IP04687 e2S 45o.ei 2 -0.10 2 496.94 12 -0.11 2 iRO4699 e2S -e.ii 399.60 2 512.57 12 482.32 2 -0.09 2 iRO4692 02S -0.09 430.47 ' 12 393.49 ' 2 483.63 ' 2 406.98 ' 12 388.60 2 4e6.52 ' 2 411.06 ' 12 305.27 ' -2 437.94 ' 2- 41l.24 ' 12 -0.09 2 IR04699 02S -0.09 403.48 2 513.75 12 405.29 2 626.24 2 362.44 12 530-28 516.03 0,09 NOT ON 507.74 35:L. 95 -0.03 NOT ON 485.04 398.06 -0.06 NOT ON 505.98 516.49 628.71 332.79 417.03 394.63 405.77 389.69 484.94 398.23 657.83 420.-71 Z35.25 -e.i NOT ON 450.01 496.94 -0.11 NOT ON 399.6 512.57 482.32 -0.09 NOT ON 430.47 393.49 483.63 406.98 388.6 406.52 411.06 --305.27 437.94 411.24 -0.09 NOT ON 403.48 513.75 405.29 626.24 362.44 STUDY STUDY STUDY STUDY STUDY STUDY STUDY 1103 IF:04703 IR04704 PFIT # FOODJAR IR04f-05 F'.FIT# IR04706 RFIT # IR04707 FOODJAR IR04708 IR04709 FOODJRR J 14710 1..o4711 FOODJRR IR04712 IP04713 FOODJAR IR04714 iRO4715 FOODJAR IP04716 IR04717 FOOE-JAR IR04718 IRD4719 F'-ODJAR IR04720 IR04721 FOODJAR IR@4722 IP04723 FOODJRR IR04724 IR04725 FOODJAR IR04726 IR04727 FOOBJRR IR04728 IR04729 FOODJAR IR@4730 IR@4731 FOODJAR IR04732 IR047&3 FOODJAR IR04734 IR04735 RAT # FOODJAR IR04736 IR04737 FOODJAR IR04738 iRO4739 FOODJAR IR04740 IR04741 FOODJAR IR04742 IR04743 'ODJAR 025 02S 12S 0'-'S 035 03S 135 0I.S 03S 13S 03S 03S 135 035 03S 13S 03S 03S 135 035 03S 1-@-5 03S 035 13S 03S 03S 13S 03S 03S :13S 035 OZS 135 03S 03S 13S 035 03S 13S 0--@'S 07-IS 135 035 03S 135 03S 03S 13S 03S 03S 13S 03S 035 13S 03S 035 13S 03S 03S 135 4 -;9. 7.co -0.02 IR04704 04-@s 514.89 0. oi IR04705 02S 0.00 iR@4706 02S 36!!..61 471.77 41r-176. 395.10 411.10 335.19 455.51 369.38 375.59 409.47 383.39 396-87 387.52 386.35 --@i3O.22 487.20 --167.78 511.60 456.15 367.33 481.90 385.32 392.84 506.81 485.66 ' 409.44 ' 370.00 ' 571.03 ' 368.05 ' 5:10.96 405.31 347.59 601.77 5:15.67 362.26 361.63 523.78 1 386.45 ' 574.73 ' 376.41 ' 381.4e ' 439.39 ' 0.03 ' iRO4735 03S 519.71 ' 392.50 ' 607.41 ' 375.74 ' 449.55 ' 440.83 ' 379.50 462.75 353.00 394.49 455.76 579.78 357.30 2 -rd.02 12 2 e.ei 3 0.00 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 :13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 0.03 13 3 3 -13 33 13 3 3 13 3 3 13 459. 79 -0.02 NOT ON 514.89 0.01 NOT ON 0 NOT ON 365. 61 471.77 467.76 395.:l 411.1 335.19 455.51 369.38 375.59 409.47 383.39 396,87 387.52 386.35 33e.22 487.2 367.78 5:11. 6 456.15 367.33 481.9 385.32 362.84 506.81 485.66 409.44 370 571.03 368.05 510.86 405.31 347.59 601.77 515.67 362.26 361.63 523.78 386.45 574.73 376.41 381.4 439.39 0.03 NOT ON 519.71 392.5 --607.41 375.74 449.55 440.83 379.5 462.75 353 394.49 455.76 579.78 357.3 STUDY STUDY STUDY STUDY 1 104 -.,041-44 035 PAT # IR04745 03S FOODJAR i3S IR04746 03S IR04747 025 FOODJAR 13S IR04748 03S IR04749 03S FOODJAR 13S IR04750 03S iRO4751 035 PAT # FOODJPR 13S .4*04752 03S .04753 03S FOODJPR 13S IR04754 03S. IR04755 03S F -01).JAR 13S 9999999999 0.00 3 IR04744 03S :'40.50 3 5C,4.83 13 466.51 3 423.04 3 370.01 13 550.39 3 402.70 3 391.77 13 508.96 3 0.05 3 IR04751 03S 479.85 ' 13 523.67 ' 3 346.44 ' 3 370.07 ' 13 405.97 ' 3 @@@441.57 '3 329.29 ' 13 99 0 0.00 0.05 0 NOT ON 340.5 504.83 466.51 423.04 370.el 550.39 402.7 391.77 508.96 0.05 NOT ON 479.85 523.67 346.44 370.07 405.97 441.57 329.29 STUDY STUDY 1105 TWO YEAR ORRL<DIET@) TO,,,'-ONC:STUDY OF FM-_,@-,--44 -k.FC-143 IN Elw,P.# 0281CROO12 TECHf4ICIAN INITIRLS:S LJS TODAY'S DRTE:S 10/7/82 SEX OF RRTS:S FEMALE ROOM NUMBER:S D-340 WEIGHT OF FULL FOOD JAR:S 650GRRMS FFITS WEEP.'.74 IR04576 OIS RAT 0.14 ' IR04576 015 TFI 0 IR04577 OiS 55:1.16 ' FOODJAR IIS 4:@-6.16 ' iRO4578 F,'AT * OiS -0.05 ' - IR04578 OIS IR04579 015 512.21 ' FOODJAR 115 473.32 ' IR04580 015 RAT # 0.01 IR04580 OIS IR04581 @IS 510.84 FOODJAF' IIS IR04582 OIS 496.78 -0.06 F.*FIT# IR@4582 OiS TFI 0 IR04583 OIS 487.54 ' FOODJAR 115 481.81 ' IR04584 015 396.89 IR04585 015 0.04 R.FIT # IR045e5 OIS FOODJRR iiS 402.26 IR04586 015 411.08 IR0458(- 015 479..95 FOODJAR IIS 358.27 IR04588 OIS -0.03 RAT # IR04588 OiS iRO4589 OIS RAT # 0.05 ' IR04589 OiS FOODJAR IIS IR04590 015 RAT # 0.03 ' 0.00 IR04590 OIS IR04591 OIS 422.45 FOODJAR IIS 494.06 tRe4592 OIS 515.45 iRO4593 015 404.94 FOODJAR ilS 379.09 iRO4594 OIS 448.39 iRO4595 OiS 412.15 FOODJRR IIS IR04596 OIS IP04597 OIS 399.79 31e.se 453.19 FOODJAR 115 428.11 IR04598 OIS 372.52 '-14599 OIS 354.00 t JCJRR ilS :169.83 iRO4600 OiS 52e.57 iRO4601 OIS PAT # 0.05 IR0460i OIS FDODJAR ilS 481.11 IPO<6 2 ois IP04603 OIS 398.96 431.43 1 0.:14 0.14 NOT ON STUDY 0- 1 551.16 1:1 436. 16 1 -0.05 -0.05 NOT ON STUDY 1 5:12.31 11 473.32 1 0.01 0.01 NOT ON STUDY :1 510.84 11 496.78 1 -0.06 -0.06 NOT ON STUDY 0 1 487.54 It 481.81 1 396.89 1 0.04 @ 0.04 NOT ON STUDY 11 402.26 1 411.08 1 479.85 11 358.27 1 -0.03 -0.03 ' NOT ON STUDY 1 0.05 0.05 ' NOT ON STUDY It 0.02 1 0 0.00 NOT ON STUDY 1 422.45 11 494.06 1 515.45 1 404.94 11 378.09 1 448.39 1 412.15 111 3e9.79 310.8 1 453.19 11 428. :L:L I- 372.52 1 354 It 369.83 1 520.57 1 0.05 0.05 NOT ON STUDY it 481.11 :1 398.96 1 431.43 1106 FOOE)JAR Its IR04604 OIS 3f) -!5 47,E..49 IF'04605 OIS FOOC,JFIR its 4 4606 OIS :...04607 OIS F,HT # FCiF-j[JjFIF, 1:15 IF'04608 015 F,'.FI#T IR@4609 OIS FOODJAR Its IP@4610 OIS F'FIT # IR04611 OIS FOODJAF* 115 IR04612 OIS IR04613 OIS FO-DJBR Its IR04614 OIS IR04615 015 FOOE)JRR Its IR04616 OIS IR04617 OIS F,'FIT# FOODJAR Its IR@4618 015 IR04619 OIS PAT # FOOE)JAR IIS IR04620 OIS RFIT # IR04621 OIS FOODJRR Its IR04622 OIS F.,FIT# IR04622 FOODJAR IR@4624 OIS Its is IR04625 FC,ODJAR IR 4626 IR04627 FOOD.JRR IR04628 OIS IIS OIS OIS 115 OIS IR04629 OIS RAT # FOODJAR IRD4630 PFIT # liS OIS iRO4631 RFIT # FOODJAR IR0461.2 PFIT # ..-14633 i.,c # FOODJAR OIS its OIS 015 Its IR04634 OIS IP@4615 015 FOODJAR Its IR04636 OIS IPO-4627 015 419. 3Z' 517. 48 0. ro6 IR04607 OIS 5 $-r-i,.44 0.09 iRO4608 OIS 442.25 4e.5.68 0. 08 IR04610 OIS 514.08 ' 4t37. 94 ' 422.66 ' 51.6..25 ' 368.10 455.30 44-7@.. 48 -@7,1. 1-7 -7:55.48 -0.04 IR04611- OIS 5:@3.69 476.37 0.07 IRD4619 OiS 490,.04 o.rds iRO469-;.'OOiS 272.62 495.19 0.08 IR04622 015 459.23 4SCi.06 444.18 402.93 3--.r6.36 484.40 490.13 333.87 504.13 0.00 IR04629 015 466.38 0.01 IR04630 O:LS 0.01 IR04631 OIS 0.00 0.02 IR046--,,2OIS 0. 03 IR04633 015 0.03 351.64 474.57 349.94 425.50 412.07 0.06 :Ll 1 0.09 1 11 1 0.08 1 it 1 1 It 1 1 11 1 1 -0.04 It 1 :L 11 1 1 11 1 1 :It 0.07 0.08 0.08 1 1 11 1 1 11 1 1 @ 0.00 11 1 0.01 1 0.01 11 I- 0.02 1 o.o-@ It 1 1 11 1 1 391@. 75 4i@E..49 332.37 419. 3:1 517.48 0. OE. NOT ON STUDY 5C,0.44 0.09 NOT 014 STUDY 442.25 485.68 0. oc-; NOT ON 514.08 4,E.7.94 STUDY 422.66 516.25 368.1 455.3 443.48 --<71.77 255.4e -0.04 NOT ON 533.69 STUDY 476.37 0.07 NOT ON STUDY 498.04 0.08 NOT ON STUDY 372.63 495.19 0.08 NOT ON STUDY 459.23 480.06 444.18 4e2.93 336. 36 484.4 490.13 333.87 504.13 0 NOT ON 466.38 STUDY 0.01 NOT ON STUDY 0. O:L NOT ON STUDY -o 0.02 NOT ON STUDY 0.03 NOT ON STUDY 0.03 351.64 474.57 349.84 425.5 4;12.07 1107 FOODJAR IP04E.38 OiS iRO4639 015 RFIT # FOOE)JAR IIS IR04640 015 P-T IR04641 025 RFIT * IR04642 02S RFIT # FOODJAR 12S TA iRO4643 02S IR04644 02S FOOHJRR@i2S IR04645 02S IR04646 02S FOOC,,JAR 12S IR04647 02S IR04648 02S FQODJAP 125 IF:04649 02S IR04650 025 FOOE)JAR 12S IR04651 025 iRO4652 02S PST # FOODJAR 12S IR04653 025 IR04654 02S RFIT # FOODJAP IR 4655 F'FIT # i2S 0-'S IR 4656 025 PFIT # FOODJAR 125 IR04657 025 IR04658 025 FOODJRR 12S IR04659 02S IR 4660 02S FO-DJAR 12S IR04661 e2S IR04662 e2S FOODJRR 12S IR 4663 025 IR04664 02S RAT # FOODJAR 12S TFI IR04665 02S f-84. :L5 - Ei.cl,> IR@46---'9 OIS 462.72 -0.09 iPO4640 OIS 0 -0.09 IR04641 02S -0.06 iRO4642 02S -0.03 0 475.81 406..23 4.-4.4E> 435.76 -4 0. 7 9 454.23 --<42.81 "@'9;2..43 3 t-7-.,89 519.53 3E.E..30 246.05 e.ei IR04652 02S 470.46 ' 520.35 ' o.ee IR04654 02S 481.72 0.02 IR 4655 025 -0.01 IR 4656 02S 0.00 406.96 386.95 392.98 40-6.76 406.32 405.03 430.15 398.56 356.72 402.04 -0.135 iRO4664 02S- 530.78 0 1 :L -0. :li 1 0 2 2 12 a 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 :12 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 0 2 -0.09 -e.e-q -0.06 0.01 0.00 0.02 -0.01 -0.05 354.01 !5:B4.:15 0. 0 _-@ NOT ON 462.72 -c4.09 NOT 014 STUDY STUDY -Cl.09 NOT ON -0.06 NOT ON -0.03 STUDY STUDY 373.53 475.81 406-23 474.46 4--<5.76 340.79 454.23 342.81 398. 43 367.89 519.53 366.3 346.05 0.01 NOT ON 470.46 520.35 0 NOT ON 4el.72 0.02 NOT ON -LA.01 NOT ON 0 406.96 386.95 392.98 486.76 406.32 405.03 430.15 390-..56 356.72 402.04 -0.05 NOT ON 531D.78 STUDY STUDT' STUDY STUDY STUDY --422.49 IR04666 025 F'-'T# @ JCIJAR 12S IR04667 025 TA 1$04668 02S TA FOODJAR 125 -0.05 IR04666 02S 500.39 ' 346.78 ' 0 467.48 ' 0 335.69 ' 2 -0.05 12 2 0 2 0 12 -0.05 NOT ON STUDY 5 0 0. 3'-4 346.78 467.48 335.69 1 108 IP04669 P.FIT # IP04670 02S FOOC,JFIP 12S IR04671 025 PFIT # IR04672 02S FO-DJRS@12S '-14673 02S @......,3467402S F.FIT# FOOE)JAR 12S IR@4675 e2s IR04676 02S PFIT # FOODJAR 12S IR04677 Ot-@S IR04678 02S RAT # FOO[)JFTR 12S IR04679 02S IR04680 02S FOODJRR 12S IR04681 02S IR04682 02S FOODJAR 125 IR04683 025 IR04684 02S FOODJAR 12S IR04685 02S IR@4686 02S TFi FOOE)JAR 12S TA IR04687 02S F:FIT # IR04688 025 FOODJAR 12S IR04689 025 R.FIT # IR04690 02S FCIODJRR i2S IF'04691 02S IP04692 025 P.FIT # FOODJAR 12S IR04693 02S iRO4694 02S FOODJAR 12S iRO4695 02S iRO4696 02S FOODJFIR 12S iRO4697 02S IR04699 02S FOODJAR 12S IP04699 e2S F;.T'Fi# IRL14700 02S FOODJAR 12S -1:44701 02S .,@4702 02S FOODJRR 12S IR047e3 e2S IR04704 02S PAT # FOODJRR 12S IP04669 02S 505.07 487. -q7 -0-09 IR@4671 02S 429.37 496.47 491..91 -0. 06 iRO4674 02S 53t3. 6:i 35@q.01 -0.03 IR04676 025 520.84 ' 422.54 ' 0.04 ' IR04678 02S 478.95 ' 525.25 ' 6'-15.98 ' 346.61 ' 435.04 ' 441.45 ' a5l.44 " --198.80 492.57 377.85 650.72 424.5 0 352.26 ' 0 -0.02 ' IR04687 02S 45--@.47 ' 494.12 ' -0.05 IR04689 025 409.67 503.oe 497.98 -0.04 IR04692 02S 461.82 ' 408.44 ' 491.8:1 ' 407.90 ' 387.31 ' 423.33 ' 399.99 ' 317.98 451.55 386.40 -0.04 IR04699 025 4C4:3.30 508.10 422. 75 629.61 350.02 478.74 0.01 IR04704 02S 481.37 2 &3. 0.@ 2 12 2 -0.09 2 12 2 2 -0.06 12 2 2 -0.03 12 2 2 0.04 12 2 2 12 2 2 12 2 2 12 2 2 0 12 0 2 -0.*02 2 12 2 -0.05 2 12 2 2 -0.04 12 2 2 12 2 2 12 2 2 12 2 - -0. 04 2 12 2 2 12 2 2 0.01 12 0.07 NOT ON 505-07 487.97 -0.09 NOT ON 429.37 496.47 491.91 -0.06 NOT ON 536.63 358.L-41 -0.03 NOT ON 520.84 422.54 0.04 NOT ON 478.95 525.25 635.98 346.61 435.04 441.45 351.44 398.8 492.57 377.85 650.72 424.5 ST-Lit@Y STUDY STUDY STUDY STUDY 352.36 -0.02 NOT ON 453.47 494.12 -0.05 NOT ON 409.67 503 497.98 -0.04 NOT ON 461.82 408.44 49:1.Bi 407.9 387.31 423.33 399.99 317.98 45:1.55 386.4 -0.'04 NOT ON 403.3 508.1 422. 75 629.61 350.02 478.74 0.01 NOT ON 481.37 STUDY STUDY STUDY STUDY STUDY 1 109 IP04705 025 F.'FTl # IRC44706 035 RAT # IR04,707 03S FLIODJFIR i3S IR04708 03S iRO4709 035 F',OD JFIP 13S J4710 03S IP.C,4.-11 FOCiHJRR@12S IR04712 OZS 0.00 2 IR04705 0 --'S -0.00 3 0. OCI IR04701-. OaS -0.00 -@70. --,.7 :1 496. 50 13 4e.5.06 3 42:<.Oi 3 931. 03 13 340.51 3 4 1. 14 3 7. 5 9 13 3 IR04713 FOO DJAR IF'04714 iRO4715 FIDODJAR IR047i6 IR04717 FOOE)JAP IR04718 T Fl IR04719 FOODJAR IR04720 IR04721 FOOC@JFIR iRO4722 IR04723 FOOE)JAR IR04724 IR04725 FOODJAR IR04726 IR04727 FOODJAR IR04728 IR04729 03S 135 035 035 135 03S 035 13S OZS 03S 135 OZS 03S 135 03S 035 13S 035 03S 13S OZS OZS 135 035 0--S 438.06 3 --5< 1. 44 1 433.72 3 410.58 3 314.74 :13 --,.47.24 3 496.1--l 3 --:1181i1L. 13 495.93 3 a 448.82 3 401.56 13 473.92 3 392.36 3 387.87 13 504.19 3 5.'@,i.82 3 360.87 13 2E:EI.21 3 5.'PO.21 3 359.12 13 7-:S:.<78 3 411.85 3 324.19 13 601.61 3 3 FOOD-JAR 125 IP04720 PAT # IR04721 03S FOODJAR 135 Tri IR04732 03S TA TA iRO4733 03S FOODJAR 13S IP04734 03S IR04735 03S PAT # FOODJRR 13S IF:04736 03S 4 -c@4737 07-:S t -*Il@JFiR13S IR04728 015 IR04739 03S FOODJAR 13S iRO4740 e3S IR04741 03S 366. 24 -0.00 IR04730 03S 524.85 486.53 0 594.97 0 0 378. 10 366.14 461.76 -0.02 IR04735 035 49e..19 424,83 6'@6@. 13 -s50. 54 4Lz9.6i 4 6$"-018. 348.93 478.47 366.42 .13 3 -0.00 3 13 0 3 0 0 3 13 3 a - -0.02 13 3 3 13 3 3 13 3 3 El NOT ON 0 NOT ON 7--,7 Ci. 37 496. 5 485.06 423.01 -<Si. 03 4 0. 51 4(-1.14 3L;7@ F,9 392.57 STUDY STUDY 438.06 --,1,.5 4 4 433.72 410.58 314.74 347.24 496.13 :i86.ii 495.93 448.82 401.56 473.92 392.36 387.87 504.19 531.82 360.87 386.21 590.21 3 59.:L2 538.78 411.85 324.19 601.61 527.58 366. 24 0 NOT ON 524.85 486.53 STUDY 594.97 378. 1 366.14 461.76 -0.02 NOT ON 498.19 424.83 636.13 350.54 469.61 460. 08 348.93 478-47 366.42 STUDY FOOE)JAR 13S IR0474'@-' 03S IR04743 03S FCIODJRR i2S IR04744 03S F.'.FiT# iRO4745 3S FOODJRP 13S 14746 03S IR04747 035 FOODJRR i3S IR04748 035 IR04749 03S FOODJAR 13S IR04750 035 IR04751 03S RAT # FOODJAR i3S IR04752 025 IR@4751-i 03S FOODJAR 135 IR04c@54 03S IP04'.755 03S FOQDJAR 12S 9999999999 390. 20 ' 47C4. 33 ' 560.59 ' 157. 49 ' -0.03 IR04744 035 --6@7:. 80 497.28 482.93 0 460.85 350.iS 490.08 407.01 442.98 513.30 -0.04 IR04751 035 487.97 ' 532.6a ' 358.46 369.69 418.21 460.61 341.98 99 13 3 3 13 3 -0.03 3 13 3 0 3 13 3 3 13 3 3 -0.04 13 3 3 13 3 3 13 0 290.2 470.33 580.59 357.49 -0.03 NOT ON 367. e 497.28 4a2.93 STUDY 460.85 350.18 490.08 407.0:1 442.98 51:1. 3 -0.04 NOT ON 487.97 532.68 3.58. 46 369.69 41a.21 460.61 341.98 STUDY Ti4O YEAR ORAL([.-IET) TCJ',@-OtJCSTUDY OF FC-14'-7' FM-3924 IN TECHNIC@IAN INITIALS:S SW E@...P#. 0281CRC4012 TODAY,*S DATE:S 10,,21/82 SEX OF PATS:S FEMALE ROOM NUMBEP:S D-340,D-.-@38 WEIGHT OF FULL FOOD JAP:S 650GRAMS RATS WE@EK 76 IP@4576 RAT # IR04577 FOODJAR IR@4578 PAT # IP@4579 FOODJAR IF'04580 F,'FIT# IR@4581 FOODJRP IR04582 PAT OIS 015 IIS 015 . OIS IIS 015 OIS IIS 015 0.05 ' IR04576 OIS @ 5E.O.15 " 442.86 ' 0.05 ' IR04578 015 520.63 " 481.33 ' -0.00 IR04580 OiS 5 --Z<.'6.5 479.74 0.01 IR04582 OIS 1 0.05 11 1 0.05 1 11 1 -0.00 1 11 1 0.01 0.05 NOT ON 560.15 442.86 0.05 NOT ON 520.63 481.33 0 NOT ON 533.65 479.74 0.01 NOT ON STUDY STUDv' STUDY STUDY IR@4583 OIS FOC,[.-.JFIF.I,IS IR04584 OIS iR@4585 015 FOODJAR 1R04586 IP04587 FOODJAR IP04588 PAT # OIS ilS 015 IP@4589 OIS F'FIT # FOODJAR ilS IP04590 015 f:.'AT# IR04591 015 FOOC,JRR 115 IR04592 OIS IR@4593 OIS FOODJAR 115 IR04594 015 IR04595 OiS FOODJAR ilS IR04596 OIS IR04597 OiS FOODJAR IIS IR04598 BIS IP04599 OIS )[)JRR 115 Ite.04600 @IS TFI IR04601 015 F,'AT # FOOE)JAR 115 IR04602 OIS IR04603 OIS .516.24 477.08 447.gi 0.03 4'-; 7 2 '@-'58.35 -0.04 IF'04588 OIS -0.04 IR04589 OIS -0.06 -0.05 IR04590 OIS 438.30 499. :18 535.66 411.23 356.71 447.39 424.30 361.90 280.55 458.28 409.81 380.89 --Z59.47 367, 93 541. e-I 0 -0.01 iRO4601 OIS 478.79 421.88 439.32 1 11 :1 1 1 11 1 -0.04 1 -0.04 11 1 @ -0.05 1 11 1 1 11 1 1 11 1 1 11 1 i 11 1 0 -0.01 516.24 477.08 447.61 0.03 355.61 428.56 493.72 358.35 -0.04 NOT ON -0.04 NOT ON -0.06 -0.05 NOT ON 438.3 499. IS 535.66 411.23 356.71 447.39 424.3 361.9 280.55 458.2C-l 409. 81 380.89 359.47 367. 93 541.81 STUDY STUDY STUDY -0.01 NOT ON 478.79 421.88 439.32 STUDY IP04604 JR04605 FOOE)JFIR IR04606 IR04607 P@4T # .3DJFiR IF*04608 PAT # IP04609 FOODJAR IR04610 PAT # IR04611 FOODJRR IR046i2 IP04613 FOODJAR IR04614 IR04615 FOODJRR IP04616 IR04617 PAT # FOODJHP IR04618 IR04619 PAT # FOODJAR IR04620 RAT # IR04621 FOODJAR IR04622 PAT # IR04623 FOODJAR IR04624 IR04625 FOOE)JAR IR04626 IR04627 FOODJAP IR04628 IR04629 RAT # FOODJAR IR04630 RAT # IR0463i PAT # FOODJAR IR04632 RAT # IR04623 RAT # FOODJAR 04634 IR04635 FOODJAR IR@4636 IR04637 FOODJAR IR04638 IR04639 OIS OIS Its OiS OIS ILS 015 OIS 115 015 OIS IIS OIS 015 115 015. 015 IIS OIS 015 115 OIS 015 IIS OIS OIS 115 015 015 IIS OIS 015 IIS 015 015 ilS OIS OIS IIS OIS OiS iiS OIS BIS liS 015 OiS 115 OIS OIS IIS OJS OIS 62 49C'. 87 201. 65 484.26 51-3. as -0.0-< IR04607 OIS 495.36 -0.07 IP@4608 OIS 443.10 , 497.47 " @@-0.(38 IR04610 OIS 520.30 466.42 4--3.23 531.26 --43.23 468.95 454.17 ZE.7. 81 -@63.69 -0.02 IR04617 OIS 510.1,0 510.42 -0.02 IR@4619 OIS 472.72 -0.03 IR04620 OIS 375.09 ' 496.95 ' 0.01 iRO4622 OIS 466.25 475.19 459.28 400.27 338.04 4 e.1:4.15 511.92 322.17 522.53 -0.09 IR04629 OIS 470.34 -e.ii IR04630 elS @@@P-O.i2 IR04631 015 -0. to -0.07 iRO4632 OiS -0.08 iR@4633 OIS -0.08 492.61 367.51 374.24 438.73 413.21 389.28 ' 612.06 ' -0.09 :li -0.03 it 1 -0.07 1 11 1 -0. CIS 1 11 1 -0.02 11 1 1 -0.02 11 1 -0.03 1 11 1 0.01-." 1 -0.09 it 1 -a.ii :-0.12 -0.07 -0.08 It 1 2 c, c. 4@--N2'64. 5 8 e. -0.03 NOT ON STUDY 495. 36 -Cl.07 NOT ON STUDY 443.1 497.47 0 NOT ON STUDY 520.2 466.42 423.23 531.26 34:<.23 468.95 454.17 367.Si 363.69 -0-02 NOT ON STUDY 510.18 510.42 -0.02 NOT ON STUDY 472.72 -0.03 NOT ON STUDY 375.09 496.95 0.01 NOT ON STUDY 46E..25 475. :L9 459.28 400.27 339.04 489.15 5:11.92 322.17 522.53 -0-09 NOT ON STUDY 470.34 -0.11 NOT ON STUDY 0 NOT ON STUDY -0.1 -O.e7 NOT ON STUDY --0.08 - NOT ON STUDY -0.08 492.61 367.51 374.24 438.73 413.21 389.28 612.06 -0.09 13 PHT FOODJRR IIS IR04640 CIAS PAT # IR04641 02S PAT # JR04642 02S T# FOO[fiJAP 12S IF.'4C6s4 TFi IF:04644 02S FOOD.JHR 12S IP04645 02S IF*04646 02S FOODJAR TR IR04647 IR04648 FCIOC,JAR IP04649 IR04650 12S 025 02S 125. 025 02S FOODJRP 12S TA IP@C14L--.51 02:F. IR04652 025 PAT # FOODJRR 125 IR@4653 025 IR04654 02S RAT # FOODJAR 12S IR04655 025 PAT # IR04656 02S PAT # FOO[)JAP 125 IR04657 02S IR04658 02S FOOI)JAR i2S IR04659 02S IR04660 02S FOOE-JAR 12S IP04661 025 IP04662 02S TFI TFi FOOE)JAR 12S IR04663 02S IR04664 02S PAT # FOODJAR 12S IR04665 02S iRO4666 e2S RAT # FOODJAR 12S iRO4667 02S IR04668 025 IDJAR 12S IK04669 02S RAT # IR04670 02S FOODJAR 12S IR@4671 02S PAT # iRO4672 02S 9 OIS 45-1. 51EI -0.04 iRO4640 OiS -@ri.26 IF'04641 025 0.02 IR04642 025 -0.07 2:11. 61 Cl 4E."-;3.6 480.49 4 -'9o. 36 449.00 348.11 0 460.92 :@-7 8 r--. 385. 79 387.52 514.21 -161.75 ' 0 07 ' -0.04 ' IR04652 025 482.56 ' 528.32 " -0.08 iRO4654 02S 474.44 0.01 IR04655 02S 0.22 IR04656 02S 0. 0 :, ' 411,65 ' 401.70 ' --9:9,.:4r@'' 495.40 ' 41-1.88 398. 25 4--,,6.03 415.70 0 0 354.54 ' 421.33 ' -0.05 ' IR04664 02S 527.43 ' 423.18 -0.03 IR04666 02S 496.07 336. 67 46e..96 :<82.97 0.03 IR04669 02S 5-@'2.48 ' 478.79 ' -0.00 IR04671 02S 444.77 NOT ON STUDY 452@ 5 -0. C,4 -0.04 NOT ON STUDY 2 -0.26 -0.2L; NOT ON STUDY 2 0.02 0.02 12 NOT ON STUDY -0.07 2 zii. 61 0 2 489.26 12 480.49 2 499.36 2 449 12 348.11 6 2 460.92 2 378. 86 12 385.79 2 387.52 2 514.21 12 361.75 0 2 357.07 2 -0.04 -0.04 NOT ON STUDY 12 482.56 2 528.32 2 -0.08 -0.08 NOT ON STUDY 12 474.44 2 0.01 e.o:l NOT ON STUDY 2 0.22 0.22-,' NOT ON STUDY 12 0.03 2 4:11.65 2 401.7 :12 399.48 2 495.4 2 413.88 :L2 398.25 2 436.03 2 4:15.7 0 0 :12 354.54 2 421.33 2 -0.05 -0.05 NOT ON STUDY 12 527.43 2 423.18 2 -O.L43 -0.03 NOT ON STUDY -12 --496.07 2- 336. 67 2 468.96 12 382.97 2 0.03 0.03 NOT ON STUDY 2 522.48 12 478.79 2 0 -0.00 NOT ON STUDY 2 444.77 FOOD.JRP 125 iRO4673 02S IR04674 02S F.FiT FOODJRR 12S IP04675 02S 1004676 02S . r# FOOE)JAR 12S IP04677 02S IR04678 02S PFIT # FOOE)JAR 12S IR04679 025 IR04680 02S FQODJAR 12S iRO4681 02S IR04682 02S FOOD-JAR 12S IR04683 02S@ IR04684 025 FOOE)JAR 12S IR04685 02S P.FIT # IR04686 02S FOODJAP 12S IR04687 025 PAT IR04688 02S FOODJAR 125 IR04689 02S RAT # IR04690 02S FOODJAR 125 IR@4691 02S IR04692 025 PAT # FOODJAR 12S IR04693 02S IR04694 02S FOOE)JRR 125 IR@4695 025 IR04696 02S FOODJAR 12S IR04697 02S IR04698 025 FOODJAR 12S iRO4699 02S RAT # IR04700 02S TA FOODJAR 12S IR04701 02S IR04702 e2S FOODJAR 12S IR04703 02S -IP04704 02S T# FOODJAR 12S IR04705 02S PAT # IP@4706 03S RAT # IR04707 03S FOODJAR 13S 512. 21 42*-:0.SZ, 0.02 IP04674 02S 580.81 401.21 0.02 IR04676 02S 472.68 4118.78 0.04 iRO4678 02S 480.07 5.-s-2.40 641.15 323.61 434.84 458.96 367.12 426.92 497.82 335.50 0.01 iRO4685 02S 4.-@',9.55' 497.27 ' 0.05 IR04687 02S 463.97 506.26 0.06 IR04689 e2S 422.28 ' 492.67 ' 504.18 0.01 IR04692 025 451.18 405.83 501.25 405.75 399.83 430.00 --<53.72 -"14.48 462.82 374.64 0.08 IR04699 02S 404.28 0 497.12 431.40 630.24 350-81 " 491.2.9 ' -0.14 " iRO4704 02S 461.27 ' -0.14 " iRO4705 025 -0.18 IR04706 03S 366.83 509.82 12 2 0. 0-1 12 2 2 0.02 12 2 2 0.04 12 2 2 :t2 2 2 12 2 2 12 2 0.01 2 12 2 0.05 2 :L2 512.21 429. 82 0.02 NOT ON STUDY 58C,.Bl 4C,1.21 O.k32 NOT ON STUDY 472.gS 438.76 0.04 NOT ON STUDY 480. 07 532.4 641.15 323.61 434.84 458.-Q6 3---7.12 426.92 497.82 335.5 0.01 NOT 014 STUDY 439.55 497.27 0.05 NOT ON STUDY 463.97 506.26 2 0.06 0.06 NOT ON STUDY 2 422.28 12 492.67 2 504.iS 2 0.01 0.01 NOT ON STUDY 12 451.iS 2 405.83 2 501.35 12 405.75 2 399.83 2 430 12 353.72 2 314.48 2 462.82 12 374.64 2 0.08 o.ee. NOT ON STUDY 2 404.28 0 12 497.12 2 431.4 2 --630.24 -12 250.81 2- 491.29 2 -0.14 _0.14 @ NOT 014 STUDY 12 461.27 2 -0.14 -0.14 " NOT ON STUDY 3 -0.18 -0.18 NOT ON STUDY 3 366.83 13 509.82 TH IR@4708 iRO4709 FOOE)JAR IR04710 IR047il FCIODJAR 04712 IPC,4713 FOOD-JRR IF*04-1714 IR04715 FOODJAR IR04716 IR047i7 FOODJAR IR04718 IR04719 FOODJAR IR04720 IR0472i FOOE-JAR IR04C-22 IR04722 FOOE).JAR IR04.-24 IR047*-'5 FOODJAR IR@4726 iRO4.-27 FOQDJAR IR04728 IR04729 FOODJAR IR04730 PAT # IR04731 FOODJRR IR04732 IR@4733 FOODJAR IF:04734 IR04735 PAT # FOOE)JAR iRO47a6 IR04737 FOODJAR IF'04738 iRO4739 FOODJRR iRO4740 IR04741 FOODJAR IR04742 iRO4743 FOODJAR IR04744 T# lx04745 FOODJAR IR04746 IR04747 FOODJAR 035 03S i3S 035 03S 135 03S 03S 13S 01-:5 03S 125 03S 03S i3S 03S 025 13S 03S. 035 135 025 035 13S 0-@S 03S 135 03S 03S 13S 035 03S 135 035 03S 125 025 035 13S 035 03S i3S 035 03S 135 03S e3S 13S 03S 03S 13S 03S 03S 13S 03S 035 135 03S 03S 13S 491. 8--@: 427.61 3E.6.0-> --@49.04 4e-2.63 35-11.60 " 387. 46 ' 451. 73 a77. 62 ' 4--,:41.7 ' 421.78 ' 1'7-*0.50 ' 350.9E, ' 495-12 ' 275.20 ' 510-73 456.39 349.95 479.92 395.12 424.30 545.58 506.34 3e9. 76 ' :@87.SE ' 581.15 ' 376.24 ' 541.09 ' 425.13 ' 324.15 ' 609.58 ' 5--@9.iO ' ---32.90 -C-1.02 IR04730 03S 526-94 @@ 502.41 588.39 39--<.12 367.87 462.86 0.03 IP04735 03S 507.55 ' 439.46 ' 657.03 ' 340.22 ' 480.79 ' 458.33 ' 345.61 ' 489.78 ' 368.05 356.43 479.80 584.84 346.40 0.03 IR04-1'44 03S 379.30 ' 491.94 ' 49i>.78 ' 463.99 ' 0 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 :1-@, 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 3 13 3 -3 13 3 3 13 3 3 13 -0.02-.' 0.03 0.03 491. e.:< 427.61 Cl-< 249.04 482.63 357. 6 387. 46 451. 73 277.62 434. 17 421.78 320.5 350.9 495.12 375.2 510.73 456.39 349.95 479.92 395.12 424.3 545.58 506.34 389. 76 387. 86 581.15 376.24 541.09 425.13 324.15 609.58 539.1 332.9 -0.02 NOT ON 526.94 502.41 588.39 393.12 367.87 462.86 0.03 NOT ON 507.55 439.46 657.03 340.22 4C40.79 45t3.33 345.61 489.78 368.05 356.43 479.8 --584.84 346.4 0.03 NOT ON 379.3 491.94 496.78 462.99 339.90 STUDY STUDY STUDY 1 1 16 1R04748 iRO4749 035 FOODJAR i3S IR.04750 035 IR04751 03S RAT # FOODJAR 13S iRO4752 03S IP04752 035 Fl-,OE)JAR 13S 34754 03S IP04755 03S FOOE)JAR IZS 9999999999 - 414.16 ' 412.48 ' 519.97 ' 0.01 IR04751 03S 468. 98 548.17 356.10 370. 52 416.44 4,E.6.98 342.52 99 3 13 3 3 0.01 :13 2. 3 13 3 3 13 0 .*.465.97 414.16 412.48 519.97 0.01 NOT ON 468. 9e. 548.17 356.1 370.52 416.44 466.98 342.52 STUDY 17 TI.J'-'-T''EFIFF'-IF:FIL,..[,IET1.0.:.:.-Ot4CS.TUL)'T'OF FC-14-@ Y; TEC-Hr4lC:IFlN IIAITIFILS:S 51-4 TOL)FiY-"'-[7.'-ATE:-'l-l,,,*4,-'e-2 SE,@.-O.F PHTS:S FEMALE F:CiOl,lt.JLII,lE:EF::S WEli:,HT 1--tFULL FOOD JAF,':$ 65013F.'.AIIS WEEI<'. 78 IN P.FITE. 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C12 IRC44730 35 599. 57 397. 94 476. 62 0. 03 :lRe47"-7'5 03S 507. 24 450. 99 679.53 338.23 41.-@7.99 475. 78 357@48 510. 79 369. 61 -z92,79 4.97.36 599.60 325.98 ze.ee IR04744 03S 3.70.42 3 13 3 3 13 3 3 17,1 3 3 13 2 :< I::< 3 3 13 0.02 0. e:@. 3 13 3 '3 13 -3 z 13 13 3 ZO.00 13 NCT ON --4@:4. 4 52-.. 4@14. 4 --%57. 97 501. 88 5 8 28 453. 3 394. 69 46-2. 48 45a. 41 -;,4 --<.95 362.31 514.68 361. t@ 5 2-' 466.01 375. 76 508. 67 4e5. 27 391. 64 5 7 Z-I, 522. 92 372.91 383.86 534.59 424. 99 548.13 430. 0:@. 322. 5,E 622.59 545.Pl 3 f@3. 28 0.02 NOT ON 559.53 486.23 599.57 397.94 344.79 476. 62 0 NOT ON 507.24 4!f0-. 9 9 679.53 338.23 487.98 475. 78 357.48 --510. 79 369. 61 392.79 497. 36 STUDY STUDY :125. 98 0 NOT ON 7-,70.42 481.18 STUDY 1128 IP04746 02S IR04@747 OZS FOOE@JRR 135 IF.'04748 035 IR04749 035 Fr'ODJAF, 13S 34750 ozs 521.38 469..-4 ' 2 3 4 --<.50 ' 13 417.24 ' 3 351.07 3 423.11 la 3 IP04751 OZS 0.65 3 F.'FIT# IR04-1'51 035 FOOE-JAR IR04752 IR04752 li-S 035 OSS 473.51 " 13 555.14 ' --< 362-09 ' 3 FOODJRR I":@S IR04.754 0-,:s -,z74,39 13 4 1. 2 8 3 1$04.755 0 _-SI:- 47C,.61 2 FOOC@JAR 17-S --<42.70 0.65 521.38 469.74 343. 5 417.24 351.07 423.11 522.27 0 NOT ON 473.51 555.14 362.09 374.39 413.28 478.61 342.7 STUDY 1 129 TWO YEAR ORAL(DIET", TOX-Ot.JC:STUDY OF FC.---.L4--@9.: F--11--3924 IN RRTS EXP.# 02SiCROO12 TECHNICIRN INITIALE-;:'E E;14 TODAY'S DFITE:S 12/2/62 SEX OF RATS:S FEMALE ROOM NUMBER:S D-340,D-:,@19 WEIr3HT OF FULL F(3tDE, JF41;Z:.13 WEEK 8@ IR045"'@'6 OIS F'.FIT# IR04577 015 FOODJAR IIS iRO4578 OIS PAT # IF.'04579 OIS FOODJFIR IIS IR04580 015 PAT # IP@4581 015 FOOE)JRR IIS IR04562 OIS PAT # iF'04583 OIS TFi FOODJAR IIS iPO4584 OIS IR04585 OIS PAT # FOQDJAR IIS IR04586 OIS IR04587 OIS FOODJAR IIS IP04588 015 R.FIT # 0. 09 IR04576 015 5@*5.35 456.67 Cl.04 IR04578 015 54r-'0.4 ' 41-6.56 ' 0.10 IR04580 015 47ri.40 526. 2:@ 0.08 IR04582 OIS 538.55 0 5 0 r--5'3. ' 476.78 ' 0.02 ' IR04585 OIS 448.58 ' 435.26 ' 516.19 ' 357. :13 ' 0.00 iRO4588 OIS 1 0.09 iit I 0.04 1 11 1 e.io 1 11 1 0.08 1 0 1 0.02 I:t 1 1 11 1 0.00 IR04589 015 PFIT # FOODJAR IIS -0.04 IP045890.0O.I,S e_ 1 -A-.04 11 IP04590 015 PAT # -0.03 IR04590 OIS -0.03 IR0459i FOODJRR IR04592 IR04593 FOODJAR IR04594 RAT # IP04595 FOODJRR IR04596 PAT OIS liS elS OIS IIS OIS OIS IIS OIS 455.30 521.37 ' 11 537.70 ' 1 416.15 ' 1 377.87 ' 11 -0.03 1 IR04594 eis 442.92 1 491.35 11 -0.07 1 iRO4596 OiS - -0.07 0.09 NOT ON 585@35 4'-i6@67 Ci.04 NOT ON 540.04 476.56 0.1 NOT ON 470.4 526.23 0.08 NOT ON 538.55 STUDY STUDY STUDY STUDY 508.53 476.78 0.02 NOT ON 448-58 435.26 516.19 357.1.3 0 NOT ON STUDY STUDY -0.04 NOT ON 0.02 -0.03 STUDY NOT ON 455.3 521.37 537.7 416.15 377.87 -0.03 NOT ON 442.92 491.35 -0.07 -NOT ON STUDY STUDY STUDY 34597 FOODJRR IR04598 IR04599 FOOE)JAR IR0460e IR04601 PAT 015 itS OIS OiS ilS OIS OIS 5C"1.83 ' 429-90 ' 1 3f-i.27 ' 399.68 ' @-81.00 -0.02 IR04601 OIS 1 li 1 1 li 1 1 -0.02 501.83 429.9 383.r69 371.27 399.68 581 0.02 NOT ON STUDY .1 130 FCOCIC@JFIP 115 IF'0460t'- 015 IR04603 015 FOOE)JRR 115 IR04604 OiS IP@4605 OiS PQT # . )DJAR iis IF'04606 OIS IR04607 OIS r-.'Fi#T FOOE>JAP 115 IR04608 OIS P.FIT # IR04609 FOOE)JAR OIS ilS IR04610 OIS F'AT # IR04611 015 FCIOE.'J-AR IIS. 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IR04655 02S -t3.es IP04656 02S -0.08 2 -0.08 NOT ON STUDY -o.oe. NOT ON STUDY -0.13 12 -0. 13 433.05 2 4--,:3.05 427.16 2 4 C-L'71.6 404.30 12 4 &-4-.' 3 492.93 2 492.93 421.29 2 421.29 419.04 12 419.04 442.55 2 442.55 428.15 2 428.15 404.43 12 404.43 432.68 2 432.68 -0.06 2 -0.06 IR04664 e2S -0.06 ' -.NOT ON STUDY 531.57 -12 531.57 438.56 2- 438.56 -0.12 2 -0.12 IR04666 02S -0.12 ' NOT ON STUDY 528.17 ' 12 528.17 -s-44.99 ' 2 344.99 0.19 2 0.19 IP04669 02S 0.19 NOT ON STUDY 513.03 12 513.03 0.20 2 0.2 IR04669 02S 0.20 NOT ON STUDY 1 132 01-IS FOOI@JFip 12S. IR04671 02S PAT # IRC,4672 02S FOODJAR 12S JP0467a 02S @ r# IR046-1'4 02S F'FIT# FOCI[-jFiF.*12S IR04675 02S IR04676 02S PAT # FOODJRP 125 IP04677 02S IP@4678 02S RAT # FOOE)JRP IP04679 IP@4680 FOOL)JRR IP0468i IR04682 FOOE)JRP IP04681 IP04684 FOOC@JAP. IR04685 RAT # 12S 025. 02S 12S 02S 02S 12S 02S 02S 125 02S IP04686 025 FOODJAR 12S iRO4687 02S PAT # IR04688 02S FOODJAR 12S IR@46e9 02S R.FIT# IP04690 02S FOOE-JAR 12S IF:04691 02S IF'04692 02S PAT # FOC,DJAR 12S IF:04693 02S IR04694 02S FOODJAR 12S IR046-q5 025 IR04696 02S FOODJRR 125 IR04697 02S iRO4698 02S FOODJAR 12S IR04699 02S PAT # IR04700 02S FOOD-JAR 12S I R04.!@01 02S 34(-02 02S FOODJAR 12S IR04'.703 02S IR04704 02S PAT # FQODJAR 12S IR04705 02S PAT 545. 2Cl 512. 56 -0. 07 IP04671 02S 452.7-q 52i@.E.92 -0-06 iRO4673 025 -a. IDO IR04674 025 -0. 04 383-21 0.04 IR04676 025 466.79 447.6e, -0.02 IP04678 02S 4'-;155.9 551.51 ' 6 5 *--07.e. " 313.26 ' 471.13 ' 495.60 ' 404.67 ' 43,E.0.9 519.92 403.65 -0.12 IR04685 02S 439.25 ' 507.39 ' -0.12 ' IR@4687 025 469.55 532.13 -0.12 IR04689 02S 433.35 506.52 516.47 -0.07 IP04692 02S 413.70 418.64 50e..Ii 402.75 418.41 442.04 384.36 325.89 453.05 414.97 -0.07 iRO4699 02S 391.64 ' 519.18 ' 439.10 ' 590.02 ' 416.OiE. ' 505.57 ' -0-24 ' IP04704 02S 491.27 ' -0-21 ' iRO4705 02S 545. 2 12 512. 5E. 2 -ci.e-l' -0-07 2 12 NOT ON STUDY 452.79 527.62 2 -El.06 -0.06 2 -0.00 NOT ON STUDY 0 NOT ON STUDY 12 -Cl.04 2 :@.P@1.21 2 0.04 0.04 12 NOT ON STUDY 466.79 2 447.88 2 -0.02 -0.02 NOT ON STUDY 495.59 2 !!;51.51 2 659. 78 12 313.26 2 471.13 2 4-q5.6 12 404.67 2 436.09 2 !!-199.2 12 403.65 2 -0-12 -0.12 ' NOT ON STUDY 2 439.25 :12 507.39 2 -0.12 -0.12 ' NOT ON STUDY 2 469.55 12 532.13 2 -0.12 -0.12 ' NOT ON STUDY 2 4--@:3.35 12 506.52 2 516.47 2 -0.07 -0.07 NOT ON STUDY 12 413.7 2 418.64 2 508.11 12 402.75 2 418.41 2 442.04 12 384.26 2 325.89 2 453.05 12 414.97 2 -0.07 -0.07 -2 NOT ON STUDY 391.64 12 519.iS 2 4Z9. 1 2 590.02 12 416.06 2 505.57 2 -0.24 -0.24 NOT ON STUDY 12 2 -0.21 491.27 -0.21 NOT ON STUDY IP04706 02S 0.11 P.HT # IF'04706 035 IR04707 03S --4< 1. --@-,-,: ' 3 FOOD-JRR i3S 542.04 " 13 IR04708 03S 5C,6. 4 ,-,-' 3 IR04f-c49 03S 443.80 ' 3 FR$ODJRP 13S 375.2P, ' 13 34710 03S 258. 2r:s' 3 IR04711 03S 495.71 3 FOOE)JRR 135 3'-4:7. 9 Cl :13 IR04712 01-5 --@,78.71 ' 3 IR04713 O'@@:S 453.74 ' 3 FOOE)JAR i3S 4 'I1'.@ 3 5 ' 13 IR04714 03S 472.50 ' 3 JR04715 03S 466.37 ' 3 FOOD-JAR 135 348.71 ' 13 IR04716 03S 367.62 ' 3 IR04717 03S 523.e3 ' 3 FOOE)JAR 135 393.95 13 IR047i8 03S- 520.81 3 IP04719 03S 41;-:2.91 3 FOOE)JRR 13S 374.OCI 13 IR04720 035 512.73 3 IR04721 03S 428.05 3 FOODJAR 13S 422.74 13 IR04722 581.88 3 IR04723 03S 523.86 3 FOOI:-JAP. 13S 392.20 13 IR@4724 03S 393.02 3 IR04725 03S 507.91 3 FOODJAR 13S 409.88 13 IR04726 03S 553.65 3 IR04727 03S 439.12 3 FOOD-JAR IZS 353.92 13 IR04728 025 688.86 3 IR04729 OZS 528.63 3 FOODJHP 135 480.64 13 IP@4""30 013 0.08 3 PAT # iRO4730 03S IR@472i 035 575.82 ' 3 FOODJAR 135 490.33 ' 13 IP@4732 0--15 587.27 ' 3 IR047a@7: 035 402.43 ' 3 FOOE)JAR 13S 374.78 ' 13 IP@4714 03S 474.50 ' 3 IR04.-25 03S RAT # 0.04 ' 3 iRO4735 03S FOODJAR 13S 5:10.85 ' 13 IR04736 03S 454.16 ' 3 IR04737 03S 703.06 ' 3 FOODJAR 13S 13 IR04738 03S IR04739 03S FOODJAR 13S IR04740 03S IR04741 035 FNODJAR 13S 500.55 489.89 ' 375.50 ' 513.07 ' 364.77 ' 406.:15 ' 3 3 13 -3 3 1:3 0-11 0.08 0.04 IR04742 IR0474a FOODJAR IR04744 RAT # iRO4745 01-:5 03S i3S 03S 03S 509.Si ' 6C,9.26 " 340.-q2 ' -e.03 ' IR04744 03S 400.36 ' 3 3 13 3 -0.03 3 0.11 NOT ON :@41. 33 542.04 50L;. 48 443.8 275.28 358.28 495.71 397.9 378.71 453.74 421. 35 472.5 466.37 348.71 367.6:1 52.-@@.83 393.95 530.Si 462.91 374 512.73 428.05 422.74 581.88 523.86 392.2 393.02 507.91 409.88 553.65 439.12 353.92 688.86 528.63 480.64 0.08 NOT ON 575.82 490.33 587.27 402.43 374.78 474.5 0.04 NOT ON 510.85 454.ig 703.06 359.13 STUDY STUDY STUDY 500.55 489.89 375.5 --513.07 364.77 406.:15 509.81 609.26 340.92 -0.03 NOT ON 400.36 STUDY 1134 FCOC@JAF: IR04746 IF'04747 FOODJAR IR04748 PAT # JP@4749 ( r# FOODJRR IR@4750 IR@4751 PAT # FOODJAR IR04752 IR04753 FOOI)JAR IR04754 IR04755 FQODJAR IS OIS 03S 13S OZS 035 13S 03S 03S i2S OaS 03S 135 OZS 035 135 4e.29.4 ' 472.02 ' 472.60 ' 400.60 ' 0.05 ' IR04748 03S 0.05 IR04749 035 0.04 !!-27.59 0.05 IR04751 480.42 567.77 -7.73.86 97 427.75 497.62 :,:51.75 13 482.94 3 472.02 3 472.6 13 400.6 3 0.05 0.05 ' NOT ON STUDY 3 0.05 0.05 ' NOT ON STUDY 13 0.04 3 527.59 3 0.05 0.05-.-' NOT ON STUDY 1--< 480.42 3 567.77 3 373.86 13 381. 97 3 427.75 3 497.62 13 351.75 113.5. 7WO YEAR ORAL(E)IET TO',-4-ONC:'ETUE-le C)F: F71-.--l.-49 FM---<9 4 IN RATS E.@@P. 0281CRr4O"' TECHNICIAN INITIFILE;:S S@.1 TOL@AY,'S E)ATE:S SEX OF RATS:S FEMALE ROOM NUMBER:S D-340.D-3--@:8 WEIGHT OF FULL FOOI:) WEEK 84 IR04576 OIS RAT # IP@4577 OIS FOODJAR liS IP@4578 015 PAT # . IR04579 015 r'FiT# FOOE)JAR IIS IR04580 OIS F*RT # IP04581 OIS FC,l-jE@JAR 115 IR04582 015 P.FIT # iRO4583 015 FOODJAR ilS IP04584 015 IR04585 015 RAT # FOODJAR ilS IR04586 OIS IR04587 OIS FDQDJAR liS IR04588GIS PAT TA IF*04589 OIS PAT # FOODJRR IIS IP04590 OIS RAT # IR04591 OIS FOODJAR IIS IR04592 OIS IR04593 OIS FOODJAR ilS IP04594 OIS PAT # IR04595 OIS FOODJAR IIS IR04596 OIS PAT # IR04597 OIS DC-JAF: IIS IR04598 OIS IR04599 GIS FOODJAP ilS IR04600 OIS iRO4601 OIS RAT # FOODJAR 115 -0.09 IR04576 OiS 591.15 474.75 0.98 IR04578 015 -0.12 IR04579 015 -0. 11 -0.08 IR04580 OIS 488.30 489. 49 -0. :12 IR04582 OIS 541.46 4-q2.71 458.19 -0.09 IR04585 OIS 391.15 45L-4.85 516.Z<7 376.11 -0.17 IR04588 015 0 e.ei IR04589 OIS 0.04 0.02 IR04590 OIS 467.94 505.01 539.02 417.03 424.45 0.07 IR04594 OIS' 451.78 ' 494.21 " o.r6o iRO4596 OiS 503.28 475. 13 382.48 369.73 388.22 580.61 -0.05 IR04601 OIS 501.37 :1 1. 11 1 1 11 1 1 11 1 1 11 1 1 11 1 1 li 1 0 I 11 1 1 :Ll 1 1 11 1 1 11 -I 11 1 1 11 1 1 11 -0.09 0.98 -0.12 -0.08 -0.12 -e.og -0.17 0.01 0.02 0.07 0.00 -0.05 -0.09 NOT ON STUDY 591.15 474.75 O.?S NOT ON STUDY -0.12 NOT ON STUDY -0.11 -o.es NOT ON STUDY 488.--@ 489.49 -0.12 NOT ON STUDY 541.46 492.71 458.19 -0.09 NOT ON STUDY 391.15 450.85 516.37 --,76.11 -0.17 NOT ON STUDY e.oi NOT ON 0.04 0.02 NOT ON 467.94 505.01 539.02 417.03 424.45 0.07 NOT ON 451.78 --494.21 a NOT ON 503.28 475.:13 382.48 369.73 389.22 580.6:L -0.05 NOT ON 501-37 STUDY STUDY STUDY' STUDY STUDY 1136 IR04602 IR04603 FOODJRR IR04604 IF'04605 RAT 0 rIlOE)JRR .04606 IR04607 PAT # FCTOD.JRR IR04608 RAT # IR04609 FOOE)JRR IR04610 PAT 015 OIS IIS 015 OIS 115 015 015 Its 015 OIS IIS OIS 418.56 441--1.64 392.78 517.riS -O.Cie IR04605 015 479. 34 5.@lle9.9 o.e:l IR04607 OIS 5cil. so -0.04 IP04608 OIS 4#,z9.42 51Z12.22 -0.06 IR04610 OiS 1 4:L ---(5.C- 1 449.64 11 Z,92.78 1 517.IDS 1 -o.oci 1.1 1 1 0.01 11 1 0 NOT ON 479.34 530.99 0.01 NOT ON 501..e -0.04 STUDY STUDY -0.04 ' NOT ON STUDY 1 469.42 11 502.32 1 -Cl.06 -0.06 " NOT ON STUDY iRO4611 FOODJRR iRO46i2 IR04613 FOODJRR IR04614 IR04615 FOOE)JAR iRO4616 IR04617 PAT # FOOE)JAR IP046i8 IP04619 PAT # FOODJAR IR04620 R.'AT # IR04621 FOOE)JAR IR04622 PAT # IR04623 FOODJRR IR04624 IR04625 FOOD-JAR IR04626 IR04627 FOODJRR iRO4628 IR04629 RAT # FOODJRR IR04630 PAT # IR04631 PAT # FNOD.JRP 34612 P.FIT # IP04613 F'.AT # FOODJRR IR04634 iRO46a5 FOODJRR OIS Its OIS 015 its 015 OIS Its 015 OIS LIS OIS 015 its OIS OIS 115 OIS OIS 115 015 OIS its OIS OIS iiS OIS OIS Its OIS OIS Its 015 OIS ilS 015 OIS Its 545.09 503. 65 4--@5.57 558. 5 -.' 400.45 491.66 448.89 384.49 -7:91.45 -0.03 IR04617 015 502.23 478.69 -0.05 IR04619 OIS 520.65 -0.03 iF'04620 OIS 390.74 506.76 -0.02 IR@4622 OIS 542.74 ' 446.14 ' 476.65 4&31.47 369.45 504.88 518.55 357.76 546.14 0.08 IR04629 OIS 500.7:L 0.03 IR04630 OIS 0.06 IR04631 OIS 0.05 0. 0:< iRO4632 OIS 0.03 IR04633 OIS 0.03 '-174.37 52C,.80 :184. OC, 1 :L:L 1 1 11 1 1 11 1 1 11 1 1 11 1 1 11 1 1 11 1 1 It 1 1 11 1 1 11 1 -1 - 11 1 1 -0.03 -0.05 -0.03 -0.02 0.08 0.03 0.06> e.o:i 0.03 1 11 545.09 503. 65 435.57 558. 57 400.45 491.66 448.89 384.49 391. 45 -0.03 NOT ON STUDY' 502.2L, 478.69 -0.05 NOT ON STUDY 520.65 -Cl.03 NOT ON STUDY 390.74 50--6.76 -0.02 NOT ON STUDY 542.74 44t--@.i4 476.65 401.47 369.45 504.88 5:18.55 357.76 546.14 0.08 NOT ON STUDY 500.71 O.rl3 .-NOT ON STUDY 0.06 NOT ON STUDY 0.05 0.03 NOT ON STUDY 0.03 NOT ON STUDY 0.03 374.37 526.8 384.06 1 137 IF'046-7.6 OIS IP04617 OIS F'FIT # FCIOE)JFIR ilS IFE1467-:8 OiS IR04619 015 F'r4T # -IE).JRR IIS IP@4640 015 F:FIT # IP04641 025 F.'TFl # IR04642 02S PFIT # FCIOE)JAR 12S IP@4643 02S PFIT # IR04644 02S FOODJAR 12S IR04645 02S. IF'04646 025 FC,ODJAR 125 IR04647 02S IR04648 02S FOODJAR 125 IP04649 025 IR04650 02S FOODJAR 12S IR04651 02S IR04652 025 RFIT # FOODJRR 12S IR04653 02S IP04654 02S RFIT FOODJAR 125 IR04655 02S P.FIT # IR04656 02S F,'FIT# FOOE@JFIP 12$ IR04657 02S IR04658 02S F,DC,C,.JAP 12S IR04659 02S IF:04660 02S FOOE)JRR 12S IR04661 02S IR04662 02S FOODJRR 12S IR04663 02S IR04664 e2S RnT # FOODJRR 12S IR04665 02S IR04666 02S PFIT # FC,ODJRR 125 34667 02S IR04668 02S FOQDJRR 12S iRO4669 02S 1R04670 FOOD-JRR 12S IR0467i 02S 492, -4-4 1 0.00 1 IR04EZ7 015 Cl.0 ci 484. 17 11 6 L; 75 0.02 IR04639 015 0.02 474. 90 @ 11 -ri.OC4 " I IR0464C, OIS -0.00 -0.04 IR04641 025 2 -0. 04 -0.00 2 iRO4642 025 -0.00 0. 07 :L2 0.08 2 IR0464Z Oc-'S 0.08 481.39 2 54LI.15 12 518.82 2 477.45 2 a-.74.35 12 476.26 2 5C,1.18 2 :@88.80 12 --;@87.93 2 5 --C<-..2 1 2 380.56 12 385.65 2 0.02 2 IR04652 0'-'S 0.02 46--<.52 12 430.97 2 0.10 2 IR04654 025 Q.10 6:16.C13 12 0.10 2 iRO4655 02S 0.10 0.05 2 IR04656 02S 0.05 0. 02 12 421.2.-@ 2 421.52 2 425. 57 12 473.98 2 419.97 2 419. 35 12 441.@Q9 2 427.82 2 399.95 12 414.94 2 0.12 2 iRO4664 02S' 0.12 545.08 12 449.77 2 0.09 -2 IR04666 02S - 0.09 51--<.9fs 12 32L;.01 2 2 527.17 12 2 2 536.5--@ 12 -0.09 2 492. 94 cli 140T ON 4',-2-147. 75 0.02 NOT ON 474.9 ci NOT ON -O.C44 NOT ON 0 NOT ON 0.07 0.08 NOT ON 481.39 540.15 518.83 477.45 -;,74.35 476.26 501.IP, 388.8 387.93 5--,'62.1 380.56 385.65 0.02 NOT ON 463.52 430.97 0.1 NOT ON 6.@6.03 0.1 NOT ON 0.05 NOT ON 0.02 431.23 421.52 425.57 473.98 419.97 439.35 441.99 427-82 399.95 414.84 0.12 NOT ON 545.08 449.77 0.09 NOT ON 513.96 .326.01 0.00 STUE.-Ir' STUDY STUDY STUE)IT' STUDY STUDY STUDY STUDY STUDY STUDY STUDY STUDY NOT(N STUDY 527.17 0.00 525.23 536.53 -0.09 NOT CM STUDY 1 138 PFIT IR04672 025 FOOE@JAR 12S IR0467a 025 RFIT 0 IP@4674 025 P"T 3DJAR 12S IP046-I!@5 02S TFI iF*046"76 02S F'FIT 0 FOOE)JAR 12S IR04677 02S IR04678 02S F'AT # FOQDJRR 12S IR04679 02S IR04680 025 Ft--tCi[@JRR 125 IR04681 02S IR04682 025 FOOCAJAR 12S IR04683 02S IR04684 02S FOOE.,JFiF' 12S IPC14P--:i:5025 P.FIT # IR04686 025 FOODJAR 125 IR04687 025 P.FIT# IR04688 025 FOODJRR 12S IR04689 02S PFIT IR04690 02S FOODJAR 12S IP0469i 025 IR04692 02S PFIT # FOODJAR 125 IF'04691 02S IF:04694 02S FOODJRR 12S IR04695 025 IR04696 025 FOODJRR 12S IR04697 02S IR04698 025 FOODJAR 12S IR04699 02S PFIT # IR04700 02S FOODJAR 12S IP04701 02S IR04702 02S FNODJAR 12S 34703 02S IR04704 02S F'.FIT# FOODJAR 12S iRO41-05 02S F;'FIT# IP@4706 035 RFIT IRC146.-l 0 s -0@ ol_; NOT ON STUDY 45E.. 9E. 2 456. 9tE 519@ 5:1 12 519. 51 -Cl-16 IR04671-: 02S 2 -0.16 -0.16 NOT ON STUDY -0. 12 iRO4674 02S -0.11-1 -0.12 NOT ON STUDY -0-10 12 -0. 1 Z@ 4 1 Z, 366. 41 0 0 -0.05 IR04676 02S 2 -0.05 -Eq.05 NOT ON STUDY 515.47 12 515.47 462.15 2 462.15 0.02 2 0.02 IR04678 025 - 0.02 NOT ON STUDY 476.97 12 478.97 556. 66. 2 556.66 6P-1-..95 661. 95 -@4. 1. 7a 12 341. 73 464.73 2 4L;4.73 50e..42 2 508.42 412.79 12 41.2.79 420.62 2 420.62 515.22 2 515.22 406.67 12 4rd6. 67 ri.10 2 0.1 IR04685 025 0.10 NOT ON STUDY 446.16 ' 2 446.16 506..58 ' 12 506.58 0.09 2 0.09 IR04687 025 0.09 NOT ON STUDY 4e.7.93 2 4Lzt7.93 511.86 12 5:11.86 0.09 IR04689 02S 2 0.09 0.091-., NOT ON STUDY 44&21. --7@. ' 2 440.27 504.58 " 12 504.58 518.92 ' 2 518.92 0.02-' 2 0.02 IR04692 02S 0.02 NOT ON STUDY 414.05 ' 12 414.05 428.04 ' 2 428.04 506.48 ' 2 506.48 401.69 ' 12 401.69 420.22 ' 2 420.22 429.87 ' 2 429.87 403.34 ' 12 4e3.34 320.27 ' 2 3&-L.O.27 456.46 ' 2 456.46 424.00 ' 12 424 0.04 ' 2 0.04 IR04699 025' 0.04 NOT ON STUDY 385.99 ' 2 385.99 513.15 ' 12 ..513.15 433.74 ' -2 43:<.74 495.65 ' 2- 495.65 518.95 ' 12 518.95 509.57 ' 2 509.57 -e.ie 2 -0.18 IR04"@'04 02S 467.12 -0.18 12 NOT ON STUDY 467.12 -0.13 2 -0.13 IR04705 02S -0.13 NOT ON STUDY -0.12 IR04706 03S 3 -0.12 -0.12 NOT ON STUDY 39 iRO41-07 O@:15 FC10E.-JFIP :L7-5 1PE14708 035 iR-A4709 03S FOOL-JFIF.'135 IR04 1-10 03S J 9'r!4711 OaS )DJRR laS IR[44712 035 IF'C4471-i! 02S FOCIC.,JFIR 12S IF'C'4714 OIS IP04715 OaS FOOD-JRR 13S IRC44716 03S IP04717 OZS FOODJAR i3S IR04718 035 IR04719 03S FOOE-JRR i3S IR04'.720 OaS IR04721 03S FOOE,.JAF.' IZS IR04f-22 02S F'FIT IF:0472--,.07-.S TFl FCIOE,.JAF' 1--,S IPC,4'.724 03S IR04"1'25 035 FOODJFIR 135 IR04726 03S IP04727 035 FOODJAR 13S IR@4728 03S PFIT IR@4729 02S FOODJRR 1R04730 IR@4*1731 FOOE)JAP IR047@-2 IF'047@@.2 FOOL-JFIR IF'04'714 IR04735 F'.FIT# FOODJAR IR04736 IR04737 FOODJRR IR04738 035 i'7-S@ 07@S 07-:5 1-'S 03S 015 135 03S 03S 13S 03S 1R04739 FOOE)JAP 13S IF'04f@40 03S IF'04741 035 FOODJAR IZS 34742 03S RFIT # IR04"'@41 035 FOOD-JAP IZS IF'04744 OaS RFIT # IR04745 03S '2 7 5 C'E.. --,4 4@ti. 716 :Ies.3--l E.2. 7 411. 51 492.28 378. 6iEl 451-. 75 40CI. 2C' 444. 50 4e.1.29 '-9@ 4. 50 368. 41 532.82 404.Si 51!!..72 467.22 ' 408.05 ' 512.74 ' 438.42 " 415. 89 " -0.00 " IP@4722 0--,S 57@:e,.31 0 493. 61 372.94 469.67 452.51 56:@.64 427.32 379.56 -0.105 IR04728 OZS 528.53 " :1 2 :1 13 3 2 1:,: :-, 3 13 3 3 is :i 3 13 3 3 13 i -0.00 3 0 13 3 3 13 3 3 13 3 -C.05 3 13 3 58 c-.69 " 3 504. 52 ' :13 611.21 ' 21 418. 69 ' 3 389.26 ' 13 478.20 ' 3 0.02 " 3 IR04735 035 512.72 ' 13 465.57 ' 3 0.02 704.44 ' --< 3ei.ie , 13 3 408.92 ' 521. 73 " -@-47.26 ' 43e.. 08 -0.03 IR04.742 035 E.25.45 486. 94 -0.07 IR04744 03S 394.10 3 -1:1 33 12 :11 3 13 3 3 -0.03 -0.07 --1.43.73 523. 27 ':C-,6. 34 451. 76 6 2. 17 411. 51 492.28 --7-cS. 6 457. 75 40LN. 2 444. 5 481.29 3e4. 5 36e.. 41 532.82 404.Si 515. 72 467.22 408.05 512.74 438.42 415.89 0 NOT ON 538.31 STUDY 493. 61 372.94 469.67 452.51 563.84 437.32 379.56 0. L-54 NOT ON 5r-;.S5.3 497.13 STUDY 0.01 58-11.69 504.52 611.21 418. 69 389.26 478.2 0.02 NOT ON 512.72 465.57 704.44 381.is 484.63 NOT ON STUDY STUDY 500.71 408.92 521.73 347.26 43e.. 136 0. 0 --< NOT ON STUDY 625.45 486. -c#4 -0.07 NOT ON STUDY 394.1 1 140 FOOC,JFIP 13S IR04746 0-;15 IR04747 035 FOODJAR IIS IR04748 035 RFIT # IR04749 03S F'-4T # . ODJAR ils IR04750 03S IR04751 035 F.'FIT FOOE)JRR I:S IR04752 0'-:'S IR04753 07-'S FOODJAR 12S IF'04754 07-:S IR04755 0--<S F'OC,E.,-JFiR 135 ?,-Z,99999999 494. 94 484.21 471.28 377.99 -0.07 IR04748 03S -0.05 IR04749 03S -0. 03 502.91 0.00 IR04751 03S 5;L,3.08 582.P,9 369.15 393.72 420.86 498.28 E.5. a 3 99 13 3 3 13 3 -0.07 3 -0.05 13 3 3 0.00" 13 :i 3 i-@ 3 3 iz 0 494. 94 484.21 471.28 377.99 -0.07 NOT ON -0.05 NOT ON -0.03 5rd2.91 0 NOT ON 523.08 582.89 369.15 393.72 420.86 498.28 83 STUDY STUDY STUDY 1 141 T140 YEAR ORHL(E)IET.'iTOX-or.4C STUDY OF FC-14--,.& Fti-3924 IN EXP.# 0281CROO12 TECHNIC:IRN INITLALS:S SW TODAY-'S DRTE:S 12/30./82 SEX OF RRTS:S FE148LE ROOII NUMBER:S D-33,q,C)-340 WEIGHT OF FULL FOOD JRR:S 650GRRMS RATS WEEK 86 IR04576 OIS PAT # IR04577 OIS FCiOE)JriilFS, IR04578 OiS P.FIT IR04579 OIS RAT # FOODJRR IIS IR04580 015 F-.Fl'#T IR04581 OIS PAT # FC,O[.,.JAF,:.I:LS IP@4582 OIS RAT # IR04583 OiS FOODJAR 115 IR04584 GIS IR04585 OIS PAT # FOOE)JAR 115 IR@4586 015 IR04567 OIS FOODJRF' IIS IR04!588 O:Ls PAT # IF'04589 OIS F'.FIT# FOODJAR IIS IP04590 OIS PAT # IR04591 015 FOOE)JAR IIS IR04592 OIS IR04593 OIS FOODJAR IIS IR04594 OIS PAT # IR04595 OIS FOODJAR IIS IR@4596 OIS PAT # IR04597 OIS r OE)JAR IIS -..a4598 OIS IR04599 015 FOOE)JAR IIS IR04600 OIS IR04601 OIS RAT # FOODJAR IIS -0.05 ' iRO4576 OIS 61-%.48 ' 4L;4.58 -0.08 IR04578 OIS -0.04 IR04579 OIS -0.07 -0. 1.3 IR04580 OIS -0.10 IR04581 015 -0.08 -0.09 IR04582 015 559.80 492.95 498.55 -0.02 IR04585 OIS 23 ' 447.C44 ' 516.27 398.42 -0.00 IR04588 OiS -0.02 iRO4589 OiS -0.00 0.00 iRO4590 015 464.89 516. 93 540.91 4:15.66 399.44 -0.06 IR04594 015448.14 ' 487.:12 ' -0.00 IR04596 015 515.68 457.83 393.53 279.43 :@71.. 28 556.58 0.05 IR04601 015 529.13 i I 11 1 1 1:1 :1 1 :li 1 1 11 1 1. li :L 1 :1:1 1 1 11 1 1 li. :L :L 11 1 1 :L:L -1 1 11 1 1 11 1 1 :Ll -0.05 -0.08 -0.04 -0.13 -0.10 -0.0-q -0.02 -0.00 -0.02 0.00 -0.06 -0.00 0.05 -A-.05 NOT ON STUDY E.19.48 464.58 -e.rds NOT ON STUDY -0.04 NOT ON STUDY -0.07 -0.13 NOT ON STUDY -e.i NOT ON STUDY -0.08 -0.09 NOT ON STUDY 559.8 492.95 498.55 -0.02 NOT ON STUDY 3:16.23 447.04 516.27 398.42 0 NOT ON STUDY -0.02 NOT ON STUDY 0 0 NOT ON STUDY 464.99 516.9:1 540.91 415.66 399.44 -0.06 NOT ON STUDY 448.14 487.12 0 NOT ON STUDY 515.68 457.83 393. 53 379.43 371.28 556.58 0.05 NOT ON STUDY 529. :L3 1 142 IF-04602 015 422.42 1 422.42 iRO4601 015 457.21 1 457.21 FOODJAR 115 29t--4.9. 11 49 iF*04604 1DIS 520. f4fs 1 !520. 9L; IR.Ci4605 015 0. 0 --.: 1 PAT # IPC,4,E.05 015 0. 0 0.03 NOT ON STUDY r -JE@JRF,'JIS 505. 31 ' 11 505.31 @,.,E'4606 OIS iRO4607 OIS PAT # 552. 39 ' 1 -0.05 ' 1 IR04607 015 -0.05 552.39 -0-05 NOT ON STUDY FOCIE@JFIR 115 488.63 @ li 488. 63 IR04608 OIS -0. 03 1 - 0. 0 --< P.RT # IR04608 OIS -0.03 NOT ON STUDY IR04609 015 474.42 1 474.42 FOODJAR IIS 504.73 11 504.73 IR04610 OIS PAT # 0.04 IR04610 015 10.04 0.04 NOT ON STUDY IR04611 OIS 547.93. 1 547.93 FOODJAR ilS 493.97 li 493.97 IR04612 OIS 444.01 1 444.01 iRO4613 015* 573.74 1 573.74 FOODJAR IIS 4f-11.14 li 401.14 IR04614 OIS 501.37 1 501.37 IR@4615 OIS 451.57 1 451.57 FOODJRR 115 @-'73.84 11 373.84 IR04616 OIS 392.41 1 392.41 IR04617 015 PAT # -0.04 IR04617 OIS 1 -0.04 -0.04 NOT ON STUDY FOODJAR IIS 508.79 11 508.79 IR046i8 OIS 485.10 1 485.1 IR04619 OIS PAT # -0.09 IR04619 OIS 1 -0.09 -0.09 NOT ON STUDY FOODJAR IIS 520.19 11 520.19 IR04620 OIS -0.11 1 -0-11 RAT # IR04620 OIS -0.11 NOT ON STUDY iF:0462i OIS 393.52 1 393.52 FOODJAR IIS 505.99 11 50'-i.99 IR04622 OIS PAT # -0.09 IR04622 OIS 1 -0.09 -0.09 NOT ON STUDY IR04623 OIS 571.26 1 571.26 FOOE)JAR liS 419.66 11 419.66 IR04624 015 4P,7.17 1 4.97.17 IF'04625 OIS 405.29 1 405.29 FCIQDJAR IIS --2@0. 21 11 320. 21 IR04626 OIS 509.54 1 509.54 IR04627 015 534.26 1 534.26 FOODJAR IIS 339.93 it 339.93 iRO4628 OIS 553.36 1 553.36 IR04629 OIS -0.03 1 -0.03 PAT # IR04629 015 -0.03 NOT ON STUDY FOODJAR IIS 50(3.58 11 500.58 iRO4630 OIS -0.09 1 -0.06 RAT # IR04630 015, -0.06 NOT ON STUDY iRO4631 OiS RAT # -0.06 IR04631 015 1 -0.06 -0.06 NOT ON STUDY FOODJRR liS -0.06 -11 -0.06 iRO4632 015 -0.05 1 -0.05 @"IT # IR04632 OIS -0.05 NOT ON STUDY . .04633 OIS PAT # -0.08 IR046a3 OIS 1 -0. k3a -e.e,., NOT ON STUDY FOODJAR 115 -0.06 11 -0.06 IR04634 OIS 380.91 1 380.91 IR04635 OIS 537.80 1 537.8 FOODJAR IIS 392.98 11 392.98 IR04636 OiS 501.26 1 501.26 IR04637 OIS -0.04 1 -0.04 14 PAT FOODJRR IIS IR04638 015 IP04639 OJS RAT # FOODJAR IIS IR04640 OJS ',T # -.@:0464i 02S PAT # IF:04642 02S PAT # FOODJAR 125 IP04643 02S RAT # IR04644 025 FDODJAR 12S IR04645 02S IR04646 025 FOODJAR 12S IR04647 025 iRO4648 02S TA FOODJRR 12S iRO4649 02S IR04650 025 FOOD-JAR 125 IR0465i 025 IP04652 02S RFIT TFi FOODJAR 125 IR04653 02S iRO4654 025 PRT # FOODJAR 12S TA IR04655 02S RAT # IR04656 025 F*FIT# FOOD-JAR 125 IR04657 02S IR04658 02S FOOE)JRR 125 IR04659 025 IR04660 02S FOODJAR 125 IR0466i 025 IR04662 02S FOODJAR 12S iRO4663 02S IR04664 02S RAT * FOODJAR 12S iRO4665 02S IR04666 02S RAT * r ODJAR 125 :@.,a4667 02S IR04668 025 PAT # FOODJAR 12S IR04669 02S RAT # IR04670 02S IR046a7 OIS 478.27 683.41 0.10 IR04639 OIS 483-25 0.07 IR0464e OIS 0. 15 IR04641 025 0.07 " IR04642 02S 0.04 ' 0.08 iPO4643 025 476.58 533.33 527.30 482.59 374.82 483.89 575.51 0 252.51 389.95 541.42 274.14 394.60 -0.27 IR04652 02S 0 483.62 ' 343.59 ' -0.15 ' IR04654 025 648.54 ' 0 0.03 IR04655 02S 0.09 IR04656 02S -0. ea 426.48 42C..39 430.97 504.12 4:18.73 409.87 444.17 432.70 400.37 431.41 0.04 IR04664 02S 539.35 ' 41t.79 ' 0.00 IR04666 02S 556.6:1 325.19 0.04 IR04668 02S 541.53 0.03 iRO4669 02S 498.77 :Ll :L 1 11 1 2 2 12 2 2 12 2 2 12 2 2 0 12 2 2 12 2 2 0 12 2 2 12 0 2 2 12 2 2 12 2 2 12 2 2 12 2 2 12 -2 z 12 2 2 12 2 2 -0.04 0.10 0.07 0.15 0.07 0.08 -0.27 -0.15 0.03 0.09 0.04 0.00 0.04 0.03 NOT ON 478.27 683.41 0.1 NOT ON 483.25 0.07 NOT ON 0. 15 NOT ON 0.07 NOT ON 0.04 0.08 NOT ON 476.58 533.33 527.3 4S2.59 374.82 483.88 575.51 STUDY STUDY STUDY STUDY STUDY STUDY 352.51 389.95 54i.42 374.14 394.6 -0.27 NOT ON STUDY 483.62 343.59 -0.15 NOT ON 648.54 STUDY 0.03 NOT ON 0.09 NOT ON Cd.0 --< 426.48 426.39 430.97 504.12 418.73 409.87 444.17 432.7 400.37 47-1.41 0.04 NOT ON 539.35 -.411.79 0 NOT ON 556.63 325. 19 0.04 NOT ON 541.53 0.03 NOT ON 496.77 STUDY STUDY STUDY STUDY STUDY STUDY 1 144 IR04671 RAT # IR@4672 FOODJRR IR04672 r T# l@'S OZS 02S 125 025 @L.,04674 e2S PAT # FOOE) JFLP 12S T Fi IR@4675 e2s IR04676 02S PAT # FOODJRR IP04677 IR04678 F'FIT# FOODJAR IR04679 IP04680 FOODJAR IR04681 IP04682 TA FOODJRF' IP04683 IP04684 FOODJRR iRO4685 F'.AT # IR04686 FOOE)JAR IR04687 PAT 125 02S 025 i2S 025. 02S 12S 02S 02S 12S 02S 02S 125 02S 02S 12S 02S IP04688 02S FOODJRR i2S IR04689 02S F,'AT # IR04690 025 FOODJRR 12S IF'04691 02S IR04692 02S PAT # FOODJAR 12S IR04693 02S IR04694 02S FOODJRR 125 IR04695 02S IR04696 02S FOODJAR 12S IR04697 025 IR04698 02S FOODJAR 12S IR04699 02S RAT # IR04700 025 r'lloDiAR 1.4-s@ .,04701 02S IR04702 e2s FOODJAR 12S iRO4703 025 IR04704 02S PAT # FOODJFIR 12S IR04705 02S 564. 20 " 0.05 " IR0467i 025 469. 23 ' 528.49 " 0.20 ' IR04673 025 0. 21 ' IR04674 025 0.16 ei 342.46 -0-15 iRO4676 02S 516.07 455.82 -0.19 IR04978 02S 517.92 571.23 681.37 340.69 46'@l.79 512.83 0 438.64 435.67 516.53 390.33 -0.04 IR04685 02S 438.96 511.05 0.02 IR04687 02S 487.:17 506.49 0.13 IR@4689 02S 442.17 ' 511.69 ' 523.90 ' 0.05 ' IR04692 02S 419.46 ' 436.79 ' 513.24 ' 400.72 ' 433.00 ' 439.54 ' 399.38 ' 334.19 ' 464.97 394.05 -0.04 iRO4699 02S 376.45 528.08 435. 53 412.65 506.56 523.49 0.00 IR04704 02S 476.45 ' 0. 04 ' 12 564.2 2 0.05 0.05 2 NOT ON STUDT' 40---.293. 12 528-49 2 0.2 0.20 NOT ON STUDY 2 0.23 0.23 12 NOT ON STUDY 0.16 0 2 342.46 2 -0.:15 -0.15 NOT ON STUDY 12 516.07 2 455.82 2 -0.19 -0.19 NOT ON STUDY 12 517.92 2 571.23 2 681.37 12 340.69 2 463.79 2 512.83 0 12 438.64 2 435.67 2 516.53 12 390.33 2 -0.04 -0.04 ' NOT ON STUDY 2 438.96 12 51l.05 2 0.02 0.02 ' NOT ON STUDY 2 487.17 12 506.49 2 0.13 0.13 NOT ON STUDY 2 442.17 12 511.69 2 523.9 2 O.e5 0.05 NOT ON STUDY 12 419.46 2 436.79 2 513.24 12 400.72 2 433 2 439.54 12 399.38 2 334.19 2 464.97 12 394.05 2 -0.04 -0.04 NOT ON STUDY a 376.45 12 529.08 2 435.53 2 412.65 12 506.56 2 523.49 2 0 0.00 NOT ON STUDY 12 476.45 2 0.04 1 143 RAT IR@4f@05 025 0.04 iP@4706 035 0.09 3 RAT IR04706 03S 0.09 IR04707 035 340.40 3 FOODJAR 13S 542.07 13 04708 03S 512.85 3 .K@4709 035 457.26 3 FOODJRP i3S IR04f-10 03S IR04711 035 405.01 13 267.36 " 3 451.92 " 3 FOOEAJAR 13S 370.51 13 IR04712 OZS IR04713 e3s 362.22 3 459.49 3 FOODJAR 13S 446.06 L3 IR04714 035 493.13 3 IR04715 03S 466.90 3 FOODJAR 135 367.55 13 IR04716 035. 361.96 3 IR04717 035 539.32 3 FOODJAR iZS 406.59 13 IR04718 035 451.23 3 iRO4719 035 48:@-.03 3 FOODJAP 115 480.69 13 IR@4720 03S 510.94 ' 3 IR0472i 02S 457.44 ' 3 FOODJAR 135 409.36 ' 13 IR04722 035 0.10 3 F.*AT # IR04722 035 IR04721 035 536.38 3 FOODJRR i3S 511.98 13 iRO4724 03S 382.23 3 IR04725 03S 428.05 ' 3 FOODJAR 13S 467.83 ' 13 IR04726 03S 578.75 ' 3 IR04727 035 435.01 ' 3 FOODJAF' 135 362.10 ' 13 IR04728 03S 0.05 3 PAT # IR04728 03S 0.10 O.e5 IR04729 03S FOODJRR 13S IR047aO 035 PAT # IR0473i 03S FOODJAR 13S iRO4732 03S iRO4733 03S FOODJAR 13S iRO4734 03S IR04735 03S RAT # FOODJRR 13S iRO4736 03S IR04737 03S FOODJAR 13S 1.,04738 03S IR04739 03S FOODJAR 13S iRO4740 03S IR0474i 03S FOODJAR 13S IR04742 03S 545.57 3 492.86 13 e.io 3 IR04730 03S 597.73 3 506.11 13 627.39 3 427.79 3 369.62 13 481.62 3 0.16 3 IR04735 03S 514.25 13 475.66 ' -3 711.56 ' x 378.40 13 0 0 476.93 3 529.61 3 415.93 13 532.02 3 338.74 ' 3 441.22 ' 13 0.11 3 0.10 0.16 NOT ON STUDY 0 09 NOT OPI.STUDY 340.4 542.07 512-05 48,@7.26 405.01 367.36 451.92 370.51 362.22 459.49 446.06 493.13 466.9 :@67.55 361.96 539.32 406.59 451.23 483.03 490.69 510.94 457.44 409.36 0.1 NOT ON 536.38 511.98 382.23 428.05 467.83 578.75 435.01 362.1 0.05 NOT ON STUDY STUDY 545.57 4-q2.66 e.i NOT ON 597.73 506.11 627.39 427.79 369.62 481.62 0.16 NOT ON --514.25 475.66 711.56 379.4 STUDY STUDY 476.93 529.61 415.93 532.02 338.74 441.22 0. 11 1 146 PFIT IF'.C'4743 OZS. FOODJPR 135 IR04744 03S F.'FIT# IR04745 035 r-oDjAp 13S :,...04746 035 IR04747 03S FOODJAR 135 IR04748 OaS RFIT # IR@4749 03S RFIT # FOODJAR 135 IR04750 02S IR04751 03S PFIT # FOODJHR 13S IF,04752 035 IR04753 OaS FOODJAR 13S IP04754 035 IR04755 03S FOOE)JRR 135 9999999999 IP04742 @aS 6 37 ' 493.68 ' 0.07 " IR04744 03S 409.26 ' 49:1.62 ' 457.43 " 468.38 ' 399.:L3 -rd.00 IR04748 035 O.e2 IR04749 03S 0.01 504.66 -0.03 IR04751 03S 504.45 ' 590.64 ' --,:73.20 ' 403.90 ' 428.8:1 ' 506. 5E. -@-41.03 99 0.11 3 13 3 0.07 3 :13 3 3 13 3 -0.00 3 0.02 13 3 3 13 3 3 13 3 3 :L3 0 NOT ON 631.37 493.6C-1 0.07 NOT ON 409.26 49:1. 62 457.43 468.38 399.13 0 NOT ON 0.02 NOT ON o.o:i 504.66 03 -0N*OT ON 504.45 51-40.64 373.2 403.9 428.8:1 51-16.56 141.03 STUDY STUDY STUDY STUDY STUDY 47 TWCO 17'EFiF:OPFIL(C-IETI- STUDY OF FC-14--@. $- TEC*Hr4IC:IF114INITIFIL.S:S S14 TOE@FiY.*S [.,,riTE:S SEX, I:iF F:HT5:5 FEMRLE PC'Citl NL.11-IE'ER:-'-. ..i:r,--:@4C, WEI13HT CIF FULL FOOC:- JFIR.S E.5CGFAm-c WEER-. 68 IN F:FITS IP04576 OIS PFIT # IR04577 OIS FOO[.,JFIF: :1:15 IR045'.78 OIS F.'TFi # IP04579 015 PAT # FOODJAR 115 IR04580 OIS F:RT # IRC,4581 OIS F:RT # FOODJAR 115 IP04582 015 PAT # IR0458a FOODJRR 34584 @Lr..04585 RAT 015 iis OIS 015 FOOE)JFIR IIS IR04586 015 IR04587 OIS Fr-,O[)JFiIRIS IR04588 015 F'F.lT # IR04589 015 P'.AT # F 0 C,[@J FiF,. 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C4:--@ -0.04 -0. lri 0.00 -0.08 -0..02 -0. i-7@, :L:l 1 0 -0. i:L -c4.03 NOT ON 622. 85 4:,;Cl7.4 -Cl. ol@:@ NOT ON -Cl.04 NOT ON -0.08 -Cl.I NOT ON r-A NOT ON -0.02 -0.08 NOT ON 564.42 490.53 49C'. 54 -0.02 NOT ON 4:12.27 465.2 532.74 344.18 -0. :lz NOT 014 -Cl.;13 NOT ON -0.:14 -0. :L:l NOT ON STUDY STUDY STUDY STUDY STI-FDT' STUDY STUDY STUDY STUDY STUDY IR0459i FOOCJJAR IR04592 RAT # .IR04593 FOODJFIR IR04594 F'.RT # PC44595 ODJFIR IR04596 r-:FiT# IR04597 FCIOE,JFIR IR04598 iF'04599 FOOL-JAR O:ls :L:LS OIS OIS IIS 015 OIS IIS OIS OIS ilS OIS OIS ILS 467.47 5:1:L.88 -0. o:l IR04592 OIS' 428.@-;3 ' 495.25 " -0.02 IRE44594 0 1 -Z, 4---6.66 49C'. :14 -0. o:@. IR04596 OIS 522.57 428. 72 ' 4:12.78 " --,94.92 ' a 4 c@.7'5. :L :I:L 1 1 11 -:L - 1 li 1 -O.O:L -0. C12 -O.OL l:l I 1 11 467.47 5:L:I.Be -0. ei NOT ON 428.93 -495.25 6.02 NOT ON 4,Ei>.66 49C4. 14 -0.03 NOT ON 532.57 42S. 72 4:L2. 78 394.92 348. 75 STUDY STUDY STUDY 14 8 F'F.iT FOO[fiJFiF, IIS I F.C, E.0 015 I F.C4'6 OIS FOOC@JFIR IIS. @'4t3Cl4 015 iKCi46Ci5 OIS F:Fil # FCiCt[-.JFiF., IRC'4@--.06 OlcIRL-14607 OIS F,FIT # FOOL-,JAR 115 IF.'0-4t5O8 015 FEFIT # IR04609 OIS FOCI[.-.JFlF,I'IS IR.046iO OIS F'.FIT# IR04611 OIS FOOE@JRR 115 IR04612 OIS 015 FOODJRR 115 IR04614 OIS IR04615 OIS FOOL@JAR 115 IR046i6 015 IR04617 015 F'FIT # r NOE)JAR 115 . .04618 CIIS lRt-14619 015 PAT # FOODJAR 115 IR04620 OIS F*.FIT# IR@4621 OIS FOOC-JRR IIS IR04622 OIS F:F-il#' :IF'C4'E.2 --"0:15 FOOC@JHR 115 IR04624 OIS IR04625 OIS FOODJRR IIS lPe4626 OIS IR04627 OIS FOODJAR IIS IR04628 OIS IR04629 elS r<AT # FOOE)JAR 115 IR046aO 015 F'.RT # IR04631 015 T# I-QOE)JRR 115 IR046'-@2 OIS PAT # IR@46Z3 RAT # FODDJAR IR04614 015 IIS OIS IR04601 ois 454. E.--,,-* 4.-;.-,@..6--,' 464. *,1k --<"174.?4 524.57 @i. 04 I F.r4-6IC,5 OIS 485. 7C, 557. --@7. - El.0 --< IF'.0460"-'@OIS 487.52 -0. 05 iRO4608 OIS 484. C,--,' 4 4. 79 ' r,.0,2. IRD4610 OIS 555..98 478@75 449. 60L 5"'@5. 73 @774.24 492.1-;5 458. -;3.k 2L-2.68 392.47 -0.14 -IR04617 OiS 521.41 ' 488.89 ' 0.09 IR04619 015 510.4--@ 0.57 iRO4620 OIS 95. 4 0 477. 9,E -0.00 IRC'4622 015 5'E.6.97 " 443.09 ' 505.22 ' 423.82 ' 346.49 ' 509.98 ' 540.75 ' 347.09 ' 556.34 ' 0.11 IR04629 015 487.09 0.02 IR04630 OIS o.ei IR04611 OIS 0. 00 - CL*i.03 IR04632 015 0.02 IR0463Z 015 -0.00 386.19 -0. oci 11 It 1 1 11 1 1 It 1 1 :it 1 :1 11 1 1 11 1 1 11 1 1 :1:1 1 1 0. 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C4.cl;L NOT ON -CTLIE-Y ci Cl.ci 0. 0 NOT Citq T U C,Y 4 74 I_-" 48 7 ci Cl. C4 C-."l NOT Cit-A T Li[,'T' 541. 85 50C4. 2 E,' ri. ci2 -Cl. 02 NOT ON -'-.TUE)Y -0. 02 :I- NOT ON STUL-Y ci 02 NOT 014 E-TUDY Cl. CI.LL NOT rit-4@;TULOY I ci 50,zl.49 -1201 FC,C,EAJFiF,. IF'C'4f@54 Cl-.5 IP.CI,1'1'755 FCICIE-jFiF: C@ -74 4C,:L. -@:4 ".74 7@41. 48 4rill. 34 62 4 74 '@7-41. 4:i,, 5:?. 1202 Stephen DistnerD,.V.M. 685 Roma Avenue RosevilleM,nnesoto 55113 Appendix Item G April 18,1983 Marvin T.Case D.V.M.,Ph.D Pathology-ToxicolOgY Manager Safety Evaluation Laboratories Rkier Laboratory 218-3 3M Center St. Paul,Minnesota Dear Dr. Case: On April 15,1983 1 performed ocular eaminations on a group of approximately two year old Sprague Dawley rats being used in 3M study 0281CR-0012. All rats had their eyes previously dilated with 1% atropineprior to ocular examination. A Fison indirect ophthalmoscope was used to examine the anterior and posterior ocular segment. All findings were recorded in the laboratory notebook as per the Good Laboratory Practices Act.The changes observed in this group of animals namely a random distribution of cataracts is seen as normal ageing changes in the lens of rats of this age.There were some chronic uveitis cases and superficial keratitis problems but these again would be expected in a group of animals of this age. No ocular findings could be observed that were indicative of the compound under study. If I may answer any additional questions that you have please let me know. Sincerely, Stephen Bistner DVM -Associate professor Comp. Ophthal. .1203 APPENDIX ITEM G Two Year Oral (Diet) Toxicity-OncogenicityStudy Of Fluorochemical FC-143 In Rats IndividualOpthalmological Findings MALES Animal No. Eye Comment(s) Control *lR-3531 *lR-3534 S*lR-3539 *IR-3548 *IR-3562 S*lR-3565 S*lR-3567 *lR-3569 IR-3572 *lR-3577 300 ppm Right Left Left Right Right Right Bilateral Bilateral Bilateral Bilateral Posterior subcapsular cataract Posterior subcapsular cataract Posterior subcapsular cataract Posterior subcapsular cataract Chronic uveitis-secondardto bleeding Diffused lens capacity (hypopyon);chronic uveitis with microphthalmia Posterior lens opacity Chronic superficialkeratitis Posterior subcapsular cataract Very pale choroidal circulation *IR-3641 IR-3639 *IR-3633 *IR-3623 IR-3614 *lR-3610 *lR-3608 *lR-3593 *lR-3587 IR-3582 *IR-3622 *lR-3640 *lR-3617 30 i)pm Right Right Bilateral Bilateral Right Right Right Left Right Bilateral Right Bilateral Right Left Chronic superficialkeratitis Dacryadenitis Chronic superficialkeratitis Chronic superficialkeratitis Chronic superficialkeratitis PhthisisBulbi (secondaryto bleeding) Posterior subcapsular cataracts Posterior subcapsular cataracts PhthisisBulbi (secondaryto bleeding) Chronic uveitis Anterior synechia Diffuseg lens opacity Atrophy- Focal posterior capsul lens opacity *IR-3658 *IR-3662 IR-3666 *lR-3680 1R-3687 Right Left Right Left Right Focal corneal opacity wilh pannus Ocular (corneal)opacityOcular (corneal)opacity@ Ocular (corneal)opacity@ Atrophy NOTES: indicates blood sampling taken from eyes. indicates animal had possible SDA viral involvement. indicates clinicalobservationsign. 1204 APPENDIX ITEM G Two Year Oral (Diet) Toxicity-OncogenicityStudy Of Fluorochemical FC-143 In Rats Individual OpththlmologicFindings FEMALES Animal No. Control *lR-4583 S*lR-4584 S*IR-4599 S*lR-4602 *lR-4616 *lR-4620 S 1R-4623 S 1R-4625 *lR-4636 300 DE) S*lR-4642 *IR-4689 *IR-4694 30-ppm *lR-4727 *lR-4749 *lR-4750 *IR-4753 Eye Comment(s) Left Left Right Right Left Right Right Right Bilateral Left Atrophy@ Diffuse corneal opacity Chronic superficialkeratitis Corneal opacity-diffusedulcerated SOA? Focal iris staphyloma; corneal opacity (chronic uveitis with secondary exophthalmia) Dacryadinitis Atrophy- Corneal opacity, enlarged, ulcerated, partially collapsed - SDA? Iris staphyloma,focal corneal opacity, ulceration Posterior subcapsular cataract Right Right Right Right Right Right Left Atrophy@ Atrophy@ Atrophy@ Atrophy a Atrophy a Atrophy@ Diffused lens opacity with pannus micro-ophthalmia NOTES: indicates blood sampling taken from eyes. indicates animal had possible SDA viral involvement. indicates clinicalobservationsign. 12 0 Appendix Item H CC: M. T. Case F. D. Griffith J. D. Henderson P. Keller/D. C. Goenner C. E. Lude W. C. McCormick J. R. Nelson/I. Porietis R. A. Nelson R. E. Ober/J. D. Johnson R. A. Prokop/V. Pothaprogada L. J. Sibinski (original + 1) G. R. Steffen TITLE: Protocol for Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbons FM-3924 and FC-143 in Rats. (Riker Study No. 0281CROO12) OBJECTIVE: Evaluate chronic toxic and oncogenic affects of FM-39242@and FC-143 in a two year rat study. TEST ARTICLES: FM-3924!i and FC-143-S, 3M fluorocarbons. The compounds will be supplied and, as appropriate, well characterized analytically by the Commercial Chemicals Division/3M, St. Paul, MN. Approximately 1.0 kg of FM-3924 and 2.0 kg of FC-143 will be needed for the study. CONTROL ARTICLE: Ground Certified Purina Laboratory Chow #5002. SPONSOR: Commercial Chemicals Division/3M. TESTING FACILITY: Safety Evaluation Laboratory, Riker Laboratories, Inc., St. Paul, Minnesota. DOSING INTERVAL. February - March 1981 ilirough February - March 1983. The study director will issue a detailed study schedule before start of study. TEST SYSTEM: Three hundred and thirty male and 330 female Charles River CD rats, 38-42 days old on dose day 1. The rats will be housed in hanging stainless steel cages with wire mesh floors and fronts (male - 1/cage, females - 2/cage). The room will be temperature and humidity controlled with the lights on a 12 hour light/dark cycle. JUSTIFICATION FOR SELECTION OF TEST SYSTEM: Charles River CD rats will be used because of background data obtained from previous subchronic toxicity studies in that strain of rat. TEST SYSTEM IDENTIFICATION: Each animal will be assigned a number which will be indicated on the outside of the cage and on an individual ear tag. a FM-3924 is @@Also coded Also coded technical grade as T-2999CoC as T-299SCoC FM-3422 -1206 Appendix Item H (continued) RANDOMIZATION OF TEST SYSTEM: Animals will be assigned to the various groups by using a conputer-generated random number method. DIET AND OTHER FORMULATION/ANALYTICAL SPECIFICATIONS: Treated and untreated ground certified Purina Laboratory Chow #5002 and water will be available ad libitum throughout the study. Fresh mixtures of the test article and diet will be physically mixed every one to four weeks, depending on the stability of the test articles in the chow. The sponsor will provide the necessary analytical support to characterize the test articles and the test article diet mixtures. Prestudy analytical results of the test articles must be forwarded to the test facility before the study will be initiated. Analytical characterization of the test articles will be determined prior to and at the completion of the dosing interval. Stability of the test articles in diet will be determined prior to the dosing interval using trial blend(s) or from the first blend for the dosing interval. Representative samples of each test article diet mixture will be collected by the test facility during week 3 or 4 and approximately every 13 weeks thereafter and will be submitted to the Commercial Chemicals Analytical Laboratory/3M for test article content and uniformity-of-concentration analyses. DIETARY CONTAMINANTS KNOWN TO BE CAPABLE OF INTERFERING WITH TEST ARTICLE AND ACCEPTABLE LEVELS THEREOF: No dietary contaminants are known to interfere with the test article. However, the certified diet has been analyzed by the vendor for heavy metals,.aflatoxin, chlorinated hydrocarbons, PCB, and organophosphates. DOSAGE LEVELS, ROUTE, GROUP, SIZE, ETC.: Oral (diet) dosing will be used because it appears to be an appropriate route to use for evaluating long term toxicity-oncogenicity. Also in the previous subchronic rat toxicity studies this route was used and at higher doses toxic effects were demonstrated. Test article mixtures and the control article will be given to the animals in glass food jars. Fresh treated and untreated diet will be changed on a weekly basis. Dose Group Dosage Level Group Size Control High FM-3924 Mid FM-3924 Low FM-3924 High FC-143 Low FC-143 0 ppm 100 ppm 30 ppm 10 ppm 300 ppm 30 ppm 50d, 50@ 65d, 65$ 5oc? 1 502 50d, 509 65d, 65@ 50d., so@ 1207 Appendix Item H (continued) METABOLIC DISPOSITION OF TEST ARTICLE. Previous oral (diet) subchronic toxicity studies have indicated oral absorption because compound toxic effects were produced in rats. Also preliminary metabolism studies have shown oral absorption occurs in the rat. During this study overnight (ft16 hours) urine and feces samples will be collected periodically from 5 rats/sex/dose group for analysis, as appropriate, of total organic fluorine, FC-143, FM-3422 or FC-95 (possible FM-3422 metabolite). These urine and feces samples will be collected at 2, 5, 11 and 23 months. Also at the scheduled I and 2 year necropsies, tissue samples liver, blood, kidney, spleen, lung and bone marrow (femur) will be saved from 5 rats/sex/dose group (other tissues might be suggested during the course of the study). After collection, the samples will be stored frozen. These samples are not considered an intergral part of the toxicity-oncogenicity evaluation of FM-3924 and FC-143 in rats but are taken because they may supply useful supplemental metabolic information. All the samples will not necessarily be analyzed; the extent in which they are analyzed is a matter of scientific judgement by the sponsor. The sponsor representative will be responsible for coordination of these analyses. The results of these analyses will be reported in a separate report which will be a supplement to the toxicity-oncogenicity report. CLINICAL OBSERVATIONS: Clinical observations, including palpation for possible tumors, will be recorded once a week (every 5 to 8 days); observations on all other days will be basically live/dead checks. If an animal has evidence of difficulties, it should be observed more closely so it can be euthanatized before death to obtain satisfactory tissue samples. Body weights will be recorded and food consumption will be determined once each week for the first six months, then once every four weeks until termination. The test compounds will be administered at constant ppm in diet throughout the study. EYE EXAMINATIONS: Eyes of all the control and high dose rats will be examined by a staff veterinarian by indirect ophthalmoscopy and/or slit lamp biomicroscope at the start of the study (if possible before compound administration starts), near the middle of the study (ft12 months) and during the final month of dosing. Eye abnormalities found on dai ly observations will be called to the attention of the staff vet'erinarian for further definition, as deemed necessary by the Study Director. @-I208 Appendix Item H (continued) CLINICAL PATHOLOGY: The clinical laboratory tests listed below will be conducted on 15 male and 15 female rats from each group at 3, 6, 12, 18 and 24 months. Animals selected at each time interval will be made by the use of random numbers. Blood will be obtained via venipuncture of the orbital sinus. Urine will be collected in stainless steel metabolism cages. 1. Hematology a. Total RBC b. Hemoglobin c. Hematocrit d. Total WBC e. Differential 2. Clinical Chemistry a. Total Bilirubin b. Total Protein c. Albumin d. BUN g. Glucose 3. Urinalysis a. pH b. Specific Gravity c. Albumin d. Glucose f. Alkaline Phosphatase g. CPK h. SGPT i. SGOT j. Calcium e. Bilirubin f. Occult Blood g. Ketones TISSUE PATHOLOGY: Gross necropsies will be conducted on all rats in the study. Any rat in a moribund condition should be terminated to insure satisfactory tissue samples (see below list). Samples of the various tissues will be collected from any rat which had died unless severe autolysis is present in a tissue. As an absolute minimum samples of lung, liver, kidney, brain and any tumor mass will be collected. An interium necropsy of 15 males and 15 females from each of the two high dose groups will be done at 1 year to determine if there is an indication of an oncogenic response at that time. At the end of the study, all surviving rats will be killed for gross necropsy. Samples of tissues to be fixed in 10% buffered formalin are listed below. At the 1 and 2 year necropsies, wet weights will be obtained on those tissues identified with an * on 15 rats/sex/group, selection of animals by random number tables. weights for paired organs will be recorded as a combined weight and if an organ to be weighed is involved in a large tumor mass, a weight will not be taken. (Note: Body weight will be determined on these 15 animals/sex/group prior to necropsy for calculation of relative organ weights.-) 1209 Appendix Item H (continued) aorta adrenal (2)* brain* (3 sections including frontal cortex and basas ganglia, parietal cortex and thalamus; cerebellum and pons) eyes gonads ovaries ";4 testes*/e/pd'vms heart* small intestine (at least 2 areas) large intestine kidneys* liver* (2 sections) lung lymph node (mesentric) mammary gland (females) pancreas pituitary salivary gland spinal cord/bone marrow (vertebrac) spleen* stomach thyroid/parathyroid/trachea/esophagu., urinary bladder uterus* or prostate any tissue masses (suspected tumors) any other gross lesions microscopic examination of formalin-fixed stained paraffin tissue sections will be performed for all animals in control and both high dose groups, including all animals in these groups dying or euthanatized during the course of the study. In addition, the following tissues will be examined microscopically from all animals in the low and mid dose groups; liver, kidney, gonads and all tissue masses. The remaining tissues listed above from all low and mid dose level animals will be saved for possible future reference. Microscopic.evaluation of additional tissues from animals in low or mid dose groups will be perfo d if indicated by experimental findings at the high dose-level. 12'10 Appendix Item H (continued) DATA ANALYSIS AND FINAL REPORT: The proposed statistical methods to be used for analysis of the data are: Dunnett's test for organ weights, percent difference from control for body weights, Chi-square for percent mortalities, tumor contraction probabilities, percent til r bearing animals and til r incidences; clinical pathology values will be compared to control animals and normal ranges. (Note: If at the time the data are to be analyzed other methods seem more appropriate, those other methods will be substituted for or used in addition to those already cited.) since it could take up to 12 months to process and read all the tissue sections, the proposed date for the final report is 15-18 months after final necropsy (approximately 3-6 months after slide reading is completed). /OZ L. j. Sibinski, BA Advanced Toxicologist Study Director M. T. Case, DVM, PhD Manager, Pathology-Toxicology Safety Evaluation Laboratory Date J D. Henderson, Jr.,VDVM, MS M@ager, Laboratory Animal Medicine and Pathology Date F. D. Grojrith, PhD Manager, Toxicology Services Sponsor Representative Date W. C. McCormir-k, MS ryaee Toxicologist Alternate Sponsor Representative -'121 1 Appendix Item H (continued) CC: M. T. Case F. D. Griffith J. D. Henderson F. Keller/D. C. Goenner C. E. Ludemann W. C. McCormick J. R. Nelson/I. Porietis R. A. Nelson R. E. Ober/J. D. Johnson R. A. Prolop/V. Pothaproganda L. J. Sibinski (original +1) G. R. Steffen Amendments to the Protocol for Two Year Oral (Diet) Toxicity - Qncogenicity Study of Fluorocarbons FM-3924 and FC-143 in Rats -(Riker Study No. 0281CROO12) Discussions by M. T. Case, F. D. Griffith, J. D. Henderson and L. J. Sibinski resulted in the following three amendments to the Protocol: 1) Due to an unforseen amount of time to refine the analytical procedures with the test articles in diet, the dosing interval has been chanaed from February-March, 1981 through February March, 1983 to April-May, 1981 though April-May 1983. 2) The number of animals in the control group has been increased from 50 male and 50 females to 65 males and 65 females. These extra 15 male and female rats will be necropsied during the scheduled one year interim necropsy. 3) The physical nature of FM-3924 prohibits a uniform, direct mixture of this test article in diet. The test article will be solubilized in a carrier (ethanol) to yield a concentrated mixture. This diet concentrate of FM-3924 will be mixed with non-treated diet to yield the assigned dosage levels. L. J. Sibinski, RA Advanced Toxicologist Study Director Date M. T. Case, DVM, PhD Date Manager, Pathology- Toxicology Safety Evaluation Laboratory Ji D. Henderson, Je., WM, MS Manager, Laboratory Animal medicine and Pathology Date --/,/j W/ -51(2- - rl F. D. GriffXbh, PhD. Date Manager, Toxicology Services Sponsor Representative W. C. McCormick, 14S bat Toxicologist Alternate Sponsor Representative -.12'12 Appendix Item H (concluded) Two Year Oral (Di*t) Toxicity-Oncogenicity of Fluorocarbon FC-143 in Rats Study Amendments to the Protocol As of study day 183, body weights and food consumption once every two weeks. will be recorded Due to the unexpected leaving of Dr. J.D. Henderson, the staff veterinarian from Riker Laboratories, the final *ye examination of the surviving controls and high dose PM-3924 and FC-143 rats will be performed by Dr. Steven Biatner, DVM, a consulting veterinary ophthalmologist. Palpation for possible tumors (masses) will occur during the weekly observation for clinical signs. Inadvertently, no tissues were taken from the male rats during the one year interim necropsy for the Metabolism group. 12 1 APPENDIX ITEM I STATEMENT OF QUALITY ASSURANCE STUDY NUMBER: 0281CROO12 (FC-143) TITLE: Two Year Oral (Diet) Toxicity/CarcinogenicityStudy of Fluorochemical FC-143 in Rats Audits and/or inspections were performed by the Riker Compliance Audit unit for the above titled study, and reported to the study director and to management as follows: Date Performed Date Reported 5/13/81 5/18/81 6/23/81 11/5/81 11/11/81 11/20/81 2/8/82 2/9/82 2/12/82 3/10/82 3/31/82 4/15/82 5/10/82 5/18/82 8/18/82 11/9/82 11/22/82 1/25/83 2/22/83 4/12/83 4/15/83 4/18/83 4/26/83 8/4/83 9/24/84 7/24/87 8/21/87 6/2/81 5/20/81 6/26/81 11/13/81 11/13/81 12/l/81 2/16/82 2/12/82 3/2/82 3/31/82 4/2/82 5/3/82 5/20/82 5/20/82 8/26/82 11/22/82 12/l/82 2/4/83 3/15/83 5/17/83 5/5/83 4/21/83 6/3/83 8/5/83 9/27/84 7/29/87 8/27/87 r Compliance Audit Riker Laboratories,Inc. B7- -z-7Date -1214 i APPENDIXITEM J CHEMICAL ANALYSES OF FC-143 AND STABILITY ANALYSIS OF FC-143 IN DIET - 1215 InternaClorrespondence Appendix Item J To. D. R. RICKER - 53-4N Frcm: L. D. WINTER - 236-2B Subject: PRE AND POSR SRUDY STUDY* #0681TS0398 COMMMCIAL CMICALS AMALYMCAL REPORT #308 ANALYSIS OF T-3141 COC (FC-143) FOR RIKER 3M February 5, 1982 Reference: CCD Analytical Request #Is 16474, 16614, 17958 A white powdered solid labeled FC-143 T-OtU7-@"(F-60l5o2t 94) (T-3141COC) was received originally on getobel, 26 and@ December --3, -19W 7for characterization and analysis. This material was anal3rze_o and used in several studies including the -two year, reedLn&,AtLtdy @T-a998COC) Riker Sbuff@ #0261CROO12. The sample was re-aralyzed for post 0681 TB0398 study with sample received from D. Riclc@-.2r9 Jan. 82. Sample was 100% solids. 'Ihe sample analyzed as follows- GLC of IvL-thylF-sters Pre Pbst C6 Acid C7 Acid C8 Ac:d (a.11isomers) Cg Acid ClC) Acid Cx Acid 0.2 o.6 97.6 .8 .2 .5 .2 .4 98.4 .4 .2 .4 All values w:Lth:Lnexperimntal and integration parawters. Elemental Analysis: Element Theo- F c N H 0 by Fll- diff. 66.13 22.27 3.24 0.92 7.42 0 Pre 66.2 22.@ 3.5 0.7 7.4 68 ppm Post 65.9 22.2 3.6 0.7 7.6 68 ppn MW - 431 1216 Appendix Item J 2 Spectroscopic Infrared spectra #16474-1 and 17958-1 are Identical and match reference spectra. NMR spectra H 8386, F 8388-9 (Pre) and 7 10163-4 (Post)are identicaland match reference spectra. Ihe chain is 79% straight chain, 9% (CF3)2CF"branching and 12% back bone branched. Conclusions FG-JJA Lot,--37 haw an araly&" w:l -13 at,-hqIr._And -Ls L LDW/hc dc: M. T. Case - 218-2 E. Gartner - 218-2 E. G. Lamprecht - 218-3 W. C. McCorynick- 220-2E-02 W. H. Pearlson - 223-6-SER. A. Prokop - 236-2B L. J. Sibinski - 218-3-3 1217 InternalCorrespondence Appendix Item J To: From: SLAect: Date: COMMERCIAL CHEMICALS ANALYTICAL REPORT #348 R. M. PAYFER - 236-2B MID STUDY PURITY CHECK OF FC-143 (T-2998CoC) FOR RIKER FEEDING STUDY NO. 0281CROO12 JUNE 22, 1982 Reference: Connercial Chemicals Analytical Requests #18319, 16474, 16614, 17958, Analytical Report 1308 A white, powdered solid labeled FC-143, Lot 37 was received on May 17, 1982 for analysis for a mid study evaluation. The material was analyzed with the following results: GLC Data (Methyl Esters) C6 Acid C7 Acid C8 Acid (all isomers) Cg Acid Clo Acid Cx Acid Area % 0.25 0.65 99.6 0.2 <O.l 0.3 Elemental Analysis: Element Theor. % % Found c H N F 0 by F- difference 22.27 0.92 3.24 66.13 7.42 0 22.3 0.6 3.6 65.3 8.2 17 ppm Titration for NH4+ to determine equivalent weight. Theoretical-eq.wt. - 431 Found 433 Infrared spectrum 118319-1 matched reference spectra. 1218 Appendix Item J 2 Conclusions: All resultsare within experimentalerror or previousones, so there has be e detected in FC-143, Lot 37. RMP/hc dc: M. T. Case - 218-2 E. G. Lamprecht - 218-3 J. D. LaZerte - 236-1 W. C. McCormick - 220-2E-02 V. Pothapragada - 236-GB L. D. Winter 236-2B -1219 InternCaolrresporbdence Appendix Item J COWEITCLAL CHEMICALS ANALYTICAL REPORT 0413 TO L. J. SIBINSKI - 218-3-3 From Subject Date R. M. PAYFER - 236-2B - --@AIO I f ke lz7v STUDY PURITY FCEHEEDCIKNGOFSTFUCD-Y143NO.(T0-224919@8CO@oC) FOR JUNE 15, 1983 RIKER Reference: Comercial Chemicals Analytical Requests #18319, 16474, 16614, 17958, 19331 Analytical Reports #308, 348 A white, powdered solid labeled FC-143, Lot 37 was received on April 18, 1983 for analysis for an end of study evaluation. The material was analyzed with the following results: GLC Data (Methyl Esters) Area % C6 Acid C7 Acid C8 Acid Cg Acid Clxn Acid c Acid (all isomers) 0.2 1.0 97.2 o.7 0.1 0.7 Elemental Analysis: Element Theor. % % Found c H N F 0 by difference 22.27 0.92 3.24 66.13 7.42 22.3 0.8 3.9 65.0 8.0 Titration for NH4+ to determine equivalent weight. 1220 Appendix Item J 2 Theoretical eq. wt. 431 Found 436 Infrared spectrum #19331-1 matched reference spectra. Conclusions: All results are within experimentalerror of previous ones, so there has been no change detected in FC-143, Lot 37. RMP/hc dc: M. T. Case - 218-2 E. G. Lamprecht - 218-3 J. D. LaZerte - 236-1 W. C. McCormick - 220-2E-02 V. Pothapragada - 236-GB L. D. Winter - 236-2B 1221 InternaClorrespondence Appendix Item i CCD Analytical Report #209 TO: mn4L-3@@ From: P. J. Colbert - 236-2B Subject: GLC Analysis of FC-143 (T-2998CoC) Blended into Ground Lab-Chow Date: April 16, 1981 REFERENCE:'CommercialChemicalsAnalytical Laboratory Request #16882 Commercial Chemicals Analytical Laboratory Method #G31-0481 Three samples of FC- 143 blended into Ground Lab Chow along with a blank lab chow sample were received from L. J. Sibinski on 2-23-81 for analysis. The samples were labeled as follows: Compound FC-143 Theoretical ppm FC-143 Top Sample 200 ppm FC-143 Mid Sample 200 ppm FC-143 Bottom Sample 200 p;xn FC-143 Blank appm All four samples were analyzed for content and stability on the initial blending day (2-23-81) and on week I and 2 post blend. The post blend samples were prepared by placing the Ground Lab Chow in 4 oz. jars on 2-23-81 and placing them in a metal cabinet without the covers on the jars, leaving the samples open to the air. The I and 2 week post blend samples were taken from the jars on 3-2-81 and 3-9-81. The results are as follows: ppm (ug/g) FC-143 on Compound FC-143 Top Sample FC-143 Mid Sample FC-Bottom Sample 2-23-81 192. 221 183/ - L) 3-2-81 212 183 183 3-9-81 201 173 159@ 7 177, I BLANK 0 0 1222 Appendix Item J L. J. Sibinski CCD Analytical Report #209 April 16, 1981 Page 2 The analytical results show some variabilitywhich needs to be explained. During our GLC method development for FC-143, we found that 0.1 or 0.2 gram samples of the Ground Lab Chow did not have a uniform distributionof FC-143. The particle size of the FC-143 powder is extremelycritical when mixing it with the Ground Lab Chow at the 200 ug/gram level. We now use 1.0 to 2.0 gram samples in our GLC analysis, which gives us a more homogeneous sample. but does not completely eliminate the non-uniformityof the FC-143 in the Ground Lab Chow. PJC/mao CC: M. T. Case E. G. Lamprecht W. C. McCormick J. D. LaZerte R. A. Prokop V. Pothapragada L. D. Winter 218-2 218-3 220-2E-02 236-IL 236-28 236-3A 236-2B 1223