Document ga6rmOQgy7G8kMDJwQMg1vXdq

Pathology and Toxicology Riker Laboratories,Inc. Building270-3S-05,3M Center St.Paul,Minnesota 55144-1000 TWO YEAR ORAL (DIET) TOXICITY CARCINOGENICITY STUDY OF FLUOROCHEMICAL FM-3924 IN RATS (RIKER Experiment No. 0281CROO12) Conducted During April, 1981 - - May, 1983 Volume 1 of 5 RIKER Laboratories, Inc. / 3M Company St. Paul, Minnesota 55144-1000 U.S.A. TWO YEARORAL (DIET)TOXIC-ITY/CARCINOGENICITY STUDYOF FLUOROCHEMICAFLM-3924IN RATS (RIKERExperimentNo. 0281CROO12) TABLE OF CONTENTS PAGE(S) REPORT SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . I INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 MATERIALS AND METHODS . . . . . . . . . . . . . . . . . . . . . . . 5 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 PRINCIPAL PERSONNEL LIST . . . . . . . . . . . . . . . . . . . . . . 26 SIGNATURE PAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 REPORT TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . 28-112 TABLE I - Analytical Analysisof FM-3924 in the Diet . . . . . . . . . . . . . . . . . . . . 28 TABLE 2 - Summary of Mean Body Weights Males . . . . . . . . . . . . . . . . . . . . . . . 29 TABLE 3 - Summary of Mean Body Weights Females . . . . . . . . . . . . . . . . . . . . . . 31 TABLE 4 - Summary of Mean Feed Consumption Per Kilogram Body Weight - Males . . . . . . . . . . 33 TABLE 5 - Summary of Mean Feed Consumption Per Kilogram Body Weight - Females . . . . . . . . . 35 TABLE 6 - Summary of Mean Absolute Feed Consumption - Males . . . . . . . . . . . . . . . . 37 TABLE 7 - Summary of Mean Absolute Feed Consumption - Female . . . . . . . . . . . . . . . . 39 TABLE 8 - Estimated Mean FM-3924 Consumption In Milligramsper Kilogram Per Day . . . . . . . . . 41 TABLE OF CONTENTS - Continued PAGE(S) TABLE 9 - Mortality Data . . . . . . . . . . . . . . . . . . . 43 TABLE 10 - Summary of Clinical Signs . . . . . . . . . . . . . 45 TABLE 11 - Summary of Ophthalmologic Changes . . . . . . . . . 47 TABLE 12 - Mean and Individual Hemogram Values - Males . . . . 49 TABLE 13 - Mean and Individual Hemogram Values - Females . . . 61 TABLE 14 - Mean and IndividualClinical Chemistry Values Males . . . . . . . . . . . . . . . . . . . . . . . 72 TABLE 15 - Mean and IndividualClinical Chemistry Values Females . . . . . . . . . . . . . . . . . . . . . . 84 TABLE 16 - Urinalysis Values . . . . . . . . . . . . . . . . . 96 TABLE 17 - Individual Organ Weight, and Absolute Mean Organ Weights, Mean Organ Relative Percent To Whole Body Weight, and Organ to Brain Weight Ratios At One Year . . . . . . . . . . . . . . . . . . . . . . 99 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 . . . . . . . . . . . . . . . . . . . . . 104 TABLE 19 - Summary of Major Microscopic Findings - Neoplastic Lesions . . . . . . . . . . . III TABLE 20 - Summary of Major Microscopic Findings - Non-Neoplastic Lesions . . . . . . . . . 112 REPORT FIGURES . . . . . . . . . . . . . . . . . . . . . . . . . . 113-116 FIGURE I - Mean Body Weights - Males . . . . . . . . . . . . . 113 FIGURE 2 - Mean Body Weights - Females . . . . . . . . . . . . 114 FIGURE 3 - Mean Feed Consumption Per Kilogram Mean Body Weight - Males . . . . . . . . . 115 FIGURE 4 - Mean Feed Consumption Per Kilogram Mean Body Weight - Females . . . . . . . . 116 TABL" OF CONTEN-TS - Continued PAGE(S) APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117-1597 ITEM A - Air Monitoring of Animal Rooms . . . . . . . . . . . 118 ITEM B - Diet AnalyticalData Sheets . . . . . . . . . . . . 125 ITEM C - Acceptable Ranges for Clinical Pathology Parameters . . . . . . . . . . . . . . . . 139 ITEM D Pathology Report by Dr. Robert G. Geil, ExternalConsultantVeterinaryPathologist . . . . . 142 ITEM E BiostatisticalAnalyses Procedures. . . . . . . . . 509 ITEM F Summary of Mean Body Weights and Individual Animal Body Weight and Feed Jar Weight Data . . . . . . . . 513 ITEM G Ophthalmoscopic Evaluation and Data By Dr. Stephen 1. Bistner, ExternalConsultant Veterinary Ophthalmologist. . . . . . . . . . . . .1578 ITEM H Copy of the Study Protocol with Amendments . . . . .1581 ITEM I Quality Assurance Unit Statement . . . . . . . . . .1588 ITEM J Chemical Analyses of FM-3924 and Stability Analyses of FM-3924 in Diet . . . . . . . . . . . .1589 TWO YEAR ORAL (DIET)TOXICITYICARCINOGENICITY STUDY OF FLUOROCHEMICALFN-3924 IN RATS (RIKER ExperimentNo. 0281CROO12) REPORT SUMMARY The purpose of this study was to assess the potentialchronictoxicity and oncogenicity of FM-3924, an industrial grade of N-ethyl perfluorooctanesulfonamidoethanol, by mixing in the diet and feeding to 50 rats per sex per dose group for two years. An interim termination and evaluation was performed at one year on 15 additional rats per sex from only the control and high-dose groups. A total of 460 Sprague-Dawleyrats (230 of each sex) were equally divided into four groups. The rats were fed diets containing either 0, 10, 30 or 100 ppm of FM-3924 for the duration of the study. In-life observations performed during the course of the study included: daily observations for abnormal clinical signs; periodic physical examinations; periodic recording of body weight and feed consumption; ophthalmoscopic examinations; and clinical pathology determinations including hematology, clinical chemistry and urinalysis. Macroscopic postmortem examinations were performed on all animals including those that died or were terminated prior to the end of scheduled dosing. Selected organ weights were obtained from all of the rats at scheduled necropsy at one year as well as from 15 rats/sex/group, randomly selected from the control and all FM-3924-treatedgroups, at the termination of the study. Selected tissue specimens were harvested from each animal at necropsy, and preserved for future histopathologic evaluation. Microscopic evaluation was performed on tissues preserved from all of the control and high-dose rats, while a similar evaluation was performed on a limited list of tissues obtained from the low- and mid-dose animals. The major in-life findings associated with FM-3924 administration consisted of a dose related decreased rate of mean body weight gain, an increase in feed consumption per kilogram of mean body weight, a slight increasein the incidenceof ataxia. A slight increasein the incidence of clonic convulsionswas seen only in the high-dose male rats when compared to the control group. In the high-dose groups, male mortality values were slightly increasedwhereas female mortality was slightly decreased when compared to the corresponding control groups. FM-3924 related hematologic changes were seen in the mid- and high-dose female rats only and consisted of a decrease in red blood.cell counts, in hemoglobin concentration,and in hematocrit values: these changeswere observedvery early in the study, but did not progress into anemia by the end of the two year dosing period. There was an increased incidenceof poikilocytosis,microcytosis,and polychromasiain the highand mid-dose females at 24 months. The degree of morphological change was generallynoted as slight. Increased liver weights and microscopic findings including hepatomegalocytosis and hepatocellular degeneration with and without necrosis,were the primary dose-relatedtoxicologicfindings observed in this study. The hepatomegalocytosiswas considered to be the result of chronic hepatocellularmetabolic stimulationby FM-3924. The severity and incidenceof the liver findingswere similarat both the one year and two year necropsies. The non-neoplasticfindings observed in this study were believed to be related to hepatocellulareffects and/or were associatedwith a mild exacerbationof anticipatedgeriatricendocrinechanges in this strain of rat and not consideredto be primary test article-relatedeffects. Specific histopathologyfindings which had an equivocal relationshipto treatment with FM-3924 include a dose-related decrease of chronic myocarditisand a statisticallysignificant,dose-relatedincrease in ovarian tubular hyperplasiain the female test article treated groups. Other findings were considered to be spontaneousin origin, and occurred either sporadicallyor at a generallysimilar incidenceamong all groups includingcontrols. The no observed adverse effect level (NOAEL) feed concentrationwas judged to be greater than 30 but less than 100 ppm of FM-3924 in the diet. Based on feed consumption data, these NOAEL concentrations corresponded to approximateaverage daily doses for both sexes of 1.5 and 5.0 milligrams per kilogramof body weight, respectively. 2. The overall incidence of hepatocellular adenomas and carcinomas was low in both control and FM-3924-treatedgroups with only the high-dose female rats possibly having a tumor incidence outside historical control 1imits. The majority of neoplasms were observed in endocrine or endocrine-sensitiveorgans which are typical neoplastic sites for older rats of this strain. The incidence of these neoplasms was similar among control and test article-treatedgroups, and did not demonstrate a unique tumor type. Based on tumor incidence, types of tumors, onset time of tumor appearance,malignancy patterns of tumors and the final mortality values at two years, FM-3924 was not considered to be carcinogenic in the rat under the design and conditions of this study. 3. TWO YEAR ORAL (DIET)TOXICITY/CARCINOGENICITY STUDY OF FLUOROCHENICALFN-3924 IN RATS INTRODUCTION This study was designed to evaluate the chronic toxicologic and carcinogenic potential of FM-3924, an industrial grade of N-ethyl perfluorooctanesulfonamidoethanol, in rats following oral administration in 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-life or dosing portion of the study began on April 21, 1981, and was completed on May 18, 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 FM-3924 treatment while the results relating to the FC-143 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/documents will be maintained within the Pathology and Toxicology Department archives currently located at 3M Center in St. Paul, Minnesota. 4. NATERIALSAND NETHODS Test System: Four-hundredand sixty Sprague-Dawleyrats [Crl:COBRS 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 four groups. The control and high-dose groups each contained 65 males and 65 females, whereas the mid- and low-dose groups each 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 animals were housed in two separate rooms, one containing the control groups and one containing the FM-3924 treatment groups in order to prevent cross contamination by potential vaporization and/or sublimationof the test article. 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 addition to 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/dark cycle. 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 libitum. Test Substance/Diet Preparation: FM-3924 (Lot No. 547) 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 termination of the dosing period. No detectable changes were found in the test substance during this time (see CCD Analytical Reports Nos. 318, 347 and 412 in Appendix Item J). 5. The test substance was a straw-coloredwaxy solid which was solubilizedin ethanolprior to mixing into the diet. The formula and proceduresfor preparingthe test article/dietmixtures are contained in Appendix Item B. Prior to initiatingcompound administrationto any animals, the test substance/dietmixture was assayed. FM-3924 was found to be uniformlyblended and stable for one week in the ground feed (see CCO AnalyticalReport No. 202 in Appendix Item J). Throughoutthe study, test article/dietmixtures were prepared fresh weekly and representativesamples 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 indicatedthat the level of FM-3924was generallywithin a few percentof that desired (Table1). The rats receivedeither FM-3924-treatedor control (i.e., 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 replacedwith clean jars containingfresh diet mixtures. ExperimentalDesign: The study consisted of one control group and three treatment groups. The dosage levels and animal distributionare listedhereinafter. Treatment Groups Dosage Levels (ppm) I - Control 0 2 - High 100 3 - Mid 30 4 - Low 10 Group Size & Animal Numbers Males Females (An.Nos.) (An.Nos.) 65 (3516-3580) 65 (3696-3760) 50 (3761-3810) 50 (3811-3860) 65 (4576-4640) 65 (4756-4820) 50 (4821-4870) 50 (4871-4920) 6. An interim terminationat one year involved15 male and 15 female rats from both the control and high-dosegroups. The remaining 50 animals per sex per group continued on study. In-LifeObservations: All animalswere observed daily throughoutthe two-year dosing period. Weekly physical examinations included palpation for the presenceof masses as well as observationsfor 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 subsequenthistopathologicexamination. Body weights and feed consumption were recorded once per week for the first six months, and then once every two weeks for the remainderof the study. Eye examinationsusing indirect ophthalmoscopyand/or slit lamp biomicroscopywere performed on the control and high-doserats by the Staff Veterinarianprior to compound administrationand at approximatelyone 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 chemistry (plasma) 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. Clinicalchemistry parametersincludedtotal bilirubin,total protein, albumin, blood urea nitrogen (BUN),glucose, alkalinephosphatase (AP), creatine phosphokinase (CPK), aspartate aminotransferase (AST-formerly SGOT), alanine aminotransferase (ALT-formerlySGPT), and calcium. Urine tests included pH, specific gravity, albumin, glucose, bilirubin,occult *blood and ketones. Blood samples were collected from the retrobulbarvenous plexus of anesthetizedrats which had been fasted overnight. Blood was generally collectedfrom the right eye. Urine samples were obtained by placing each rat in an individualmetabolismcage for 20-22 hours. The specificmethods 7. 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 urine and fecal samples were collected at 2, 5, 11 and 23 months from five rats per sex per group for total organic fluoride analysis, and for the presence of FM-3924 and/or FC-95 (a FM-3924 metabolite). 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 by the RIKER Drug Metabolism Department. The results of these analyses will be reported separately. Postmortem Examinations: Gross postmortem examinations were performed on all rats which died or were terminated in extremis, on all rats terminated at the one year interim necropsy, and on all rats surviving to the end of the scheduled dosing period. 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 in situ 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 all FM-3924-treatedgroups 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. Representative samples of the following tissues and organs from each rat were fixed in 10% neutral, buffered formalin for subsequent histologic processing: 8. Aorta Adrenals(2) Brain (3 Sectionsincluding 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) Liver (2 Sections) Lung (2 Sections) Lymph node (mesenteric) 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 (suspectedtumors) Any gross lesion Light microscopic examinationwas 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-dose (Group 2) populationsregardlessof the cause of death. Microscopic examinationof tissues from the middle- (Group3) and low- (Group4) dose rats includedthe tissueslisted above except: aorta, brain, eyes, small and large intestines,lymph node(s), and spinal cord/bone marrow. The histopathologicexaminationand evaluation of these tissues was performed by Dr. Robert G. Geil, consultingVeterinaryPathologist(see Appendix Item D). BiostatisticaMlethods: The means and standarddeviationsfor body weights, feed consumption,absoluteorgan weight, relative organ weight-towhole body weight, organ weight-to-brainweight ratios and other laboratory data were determined separately for each sex and dose group. These data were analyzed using Bartlett's test for homogeneityof variance. If this test was not significantat p = 0.001, the data were further analyzed by comparingeach treated group to the control group using a two-tailedDunnett'stest at the p - 0.05 significancelevel. The 9. results of Dunnett's test have been indicated by asterisks on the mean tables. If Bartlett'stest was significantat p - 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. In addition, for each organ/lesionclassificationthe sexes were analyzed separately using a two-tailed Fisher's Exact Test comparing each treated group to the controls. An p = 0.05 significancelevel with Bonferroni's adjustment for multiple comparisons was used within each organ/lesion/sex category. 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 significant difference between the controls and the treated group. Internal RIKER memoranda pertaining to these biostatistical procedures are presented within Appendix Item E. 10. RESULTS In-LifeFindings: Body weightgainswere depressedin the FM-3924treatedmale rats comparedto the controlmale animals for only the first month and a half of the study. There was an approximate 14% decrease in the high-dose body weights by study week six and this difference was maintaineduntil the end of the study. Further, a 2-6% decrease occurred in the low- and mid-dose male groups throughoutthe study (see Table 2, Figure I and Appendix Item F). Body weight gains were also depressed in the FM-3924 dosed female rats compared to the control female animals. However, there were several differencesbetween the sexes regardingthis parameter. The onset for this change was slower, the effects were clearly dose dependent, the degree of differencefrom control values was greater, and the changes in body weight gain continued throughoutthe study for the female groups. The body weight differencescomparedto control values at the end of the study were -20.8%, -15.3% and -3.5% for the high-, mid- and low-dosegroups, respectively(see Table 3, Figure 2 and Appendix Item F). Feed consumption, measured as daily mean consumption per kilogram of mean body weight, was generally increased in all of the FM-3924-treated male and female groups over control animals. While more pronounced in the treated males, feed consumptionincreased gradually during the two year test period when compared to controlgroup feed intaki?.In the males, this change was most pronounced in the high-dose group where there was roughly a 15% increase noted with sporadic values going as high as 33% during the two year test period. In the females,the patternwas less consistentduring the first 94 weeks. There was an increasein feed consumptionduring the last 10 weeks of the study, particularlyin the mid-dosegroup, but also in the high-dose females. During this specific period, feed consumption increased as much as 35% in the mid-dose animals (see Tables 4 & 5 and Figures3 & 4). Actual feed consumption (withoutregard for body weight change) was decreased in the high-dosemales, but increasedin the mid- and low-dose male groups during the first year of the study. During the second year, all male dose groups tended to consume more feed than the comparable ii. control animals. In the female treated groups, only the low-dose group showed a very slight increase in feed consumption. During the secondyear, all of the female dose groups tended to consume less feed than the comparable controlswith the exceptionof the mid-dose group which consumed considerablymore feed than the controls during the last ten weeks of the study (see Tables 6 & 7 and Appendix Item F). Test substanceconcentrationmeasured as parts per million in the diet was determined at three month intervalswith duplicate analyses performed on two separate occasions when aberrant values were detected. The mean deviationsfrom the target concentrationof the high-, mid- and low-dose groups were +3.4%, -1.8% and +1.4%, respectively(Table 1). Actual test substance consumption was determined for every two week period for each sex and each experimentalgroup, and expressed as milligrams per kilogram per day (mg/kg/day). The mean test substance consumptionwas approximately4.5, 1.3, and 0.4 mg/kg/day for males, and 5.5, 1.6 and 0.5 mg/kg/day for females regarding the high-, mid- and low-dose groups, respectively. Mean test substance consumption values calculatedat two week intervalsfor the entire study are presentedin Table 8. Overall survivalrates, particularlyfor the male rats, were not affectedduring the two year test period. At the end of the firstyear, 15 rats/sex from the control and high-dosegroups were terminatedto fulfill protocol requirements. Therefore,the final survivalrates based on 50 rats/sex/group were 70%, 64%, 70% and 78% for males, and 50%, 68%, 51% and 44% for females regarding the control, high-, mid- and low-dose groups, respectively. A possible test substance effect may have slightly lowered the survival rate in the high-dosemale group; however, the survival rate in the high-dose females was higher when compared to control rats (see Table 9). A summary of the most commonly observed clinical signs is contained in Table 10. The only clinical sign that occurredmore frequentlyin FM-3924treated groups than control groups was in clonic convulsions,which occurredat a slightlyhigher incidencein high-dosemales. In this case, ten animals were affected whereas clonic convulsionswere seen only in three, three and four male rats in the control,mid- and low-dosegroups, respectively. There was a very slight increasein the incidenceof ataxia 12. in both sexes of the treated groups; however, there also was a background incidenceof this clinicalfindingin the controls. The FM-3924 treated population of rats experienced a suspected outbreakof sialodacryoadeniti(sSDA) viral infectionbetweenthe first and second months of the study. Clinical signs included swollen submandibular salivaryglands combinedwith occasionalocular manifestationsobserved in eight male and three female high-doseanimals, four male and three female mid-dose animals, and five male and 13 female low-dose rats. The submandibularswelling resolved within 10 days, and the incidence of residual ocular changes was extremely low. The control population had comparable signs during the sixteenthmonth of the study. Thirteen males and 13 females demonstratedsigns of this conditionwhich persisted for about 16 days from the time of onset. One male and three females developed ocularopacitiesduring this period. The incidenceof palpable tissue masses during the in-lifephase of the study was not increased in any of the FM-3924-treatedgroups when comparedto the controlrats (Table10). The results of the final ophthalmoscopicexaminations'were negative relative to any FM-3924 treatment-related effects. Changes which were observed included a random distributionof cataracts considered to be typical geriatric changes along with some cases of chronic uveitis and superficialkeratitiswhich were also consideredto be within normal limits for aging populationsof rats (see Table 11 and Appendix Item G). Many of the rats which exhibitedocular lesionswere those used to obtain blood samples via the retrobulbarvenous plexus. The high-dose female red blood cell counts were decreased below controlvalues throughoutthe two year study with statisticallysignificant decreases observed at 6, 12 and 18 months (Table 13). In contrast,the female mid-dose erythrocytecounts were statisticallyincreasedat 3 and 6 months, but were not significantlydifferentfrom control values during the last year of the study. There was an increased incidence of poikilocytosis,microcytosisand polychromasiain the high- and mid-dose females at 24 months. The degree of morphological change was generally noted as slight. Hemoglobinvalues were statisticallydecreased in the high-dose females from month 3 to month 24. Hematocrit values were statisticallydecreasedin the high-dosefemalesat the 3 month interval. 13. Changes seen in leukocyticparameters did not suggest a meaningful test substanceeffect at any FM-3924 dose levels (Tables 12 & 13). Increasedwhite blood cell counts were seen*in the male FM-3924 treated groups during the first three months of the study, but the increasewas only statisticallysignificantat the high-doseand still within an acceptablerange for all groups. The increase in leukocyteswas generally due to small increasesin neutrophilsand/or leukocytes. At six months, leukocytecounts were again slightlyelevated in all male FM-3924 treated groups with elevated neutrophil counts in the mid-dose, decreased neutrophilsin the low-dose, and significantlyelevated lymphocytecounts in both the mid- and low-dose groups. The only change seen in the FM-3924 treated females was a nonspecificdecrease in leukocytesas a result of a decrease in lymphocytesduring the first three months . Clinicalchemistry findingsat three months includedslight increases in serum alanine aminotransferase(ALT), aspartateaminotransferase(AST), alkalinephosphatase(AP) and blood urea nitrogen (BUN) in all of the FM-3924-treated male groups. The treated female groups at this same time showed only a minor rise in BUN when compared to concurrent control values. From six months until the end of the study, the high-dose (and occasionally mid-dose) male ALT and AST values were increased above both the concurrent controlsand the historicalcontrolvalues for the laboratory. AP values were also increasedduring this same time period, but rarely did these values exceed historicalcontrol limits. After six months, no meaningful changes were noted in the female groups (Tables14 & 15). Urinalysisfindings demonstrateda general, time related increase in incidenceand severityof albuminand occult blood in all of the male and female control and treated groups. These findings were more pronounced in the males than in the femalesat the end of the study. Other than an occasional incidentof slight ketonuria in both control and treated animals,there were no other remarkableurinalysisfindings (Table 16). Postmortem Findings: The consulting Veterinary Pathologist's complete report is presented in Appendix Item D. The important gross pathology findingsseen at the one year interimterminationwere limited to the high-dosemale rats in which there was an increase in the incidenceof pale and/or tan livers. This change was consideredto be most likely a 14. compound related effect. There were no specific necropsy findings in the high-dose female animals suggestiveof any alterationsrelated to the administrationof FM-3924. FM-3924 related gross findings seen in male and female high-dose rats which were either found dead, terminatedin extremis,or terminatedat the end of the studywere also limitedprimarilyto the liver. These findings included an increased incidence of hepatic masses, nodules and raised lesions,mottled livers,and yellow or pale focal lesions. There were no gross findingssuggestiveof a test substancerelatedeffect seen in the low- and mid-dose animals necropsied at comparable periods of time. Those gross pathologicfindings which were observed were not related to test articleadministration,and were typicalof findingsseen in aging rats of this strain. These findings includedmammary masses, pituitary masses and foci, ulcers on the hind footpads,pale livers, and pale, pitted and enlarged kidneys. Organ weights presented as either absolute or relative values (ie. ratio of organ/bodyweight or organ/brainweight) are contained in Tables 17 and 18. At the one year interim sacrifice'where-the only groups examined were the high-dose and controls (n - 15/sex/group),the most obvious changes in absolute weights were a statisticallysignificant decrease in body weight and an increasein liver weight for both male and female high-dose animals compared with their respective control values. Statisticallysignificantdecreases(p - <0.05) in heart and spleenweights were also noted for both the males and females of the high-dose group, and statisticallysignificantdecreaseswere seen in adrenal and pituitary weights in the high-dosemales only. Relativeweight comparisonsconfirmed the increasedliver weight in both sexes of the high dose group and in additionshowed a significantincreasein kidney and brain weights. Other statisticallysignificantaltered relativevalues in the high-dosegroup included increased uterine and adrenal weights in the females, and increasedtesticularand decreasedpituitaryweights in the males. Organ weights were obtained from all four groups at the end of the study (n - 15/sex/group).Statisticallysignificantdecreasedbody weights and increased liver weights when compared to control values were seen only in the high-dose male and female animals. The only other significant change was a decrease in spleen weights in the high- and mid-dose male 15. rats. Statisticallysignificant relative organ weight changes found in both males and females included increased liver weights in the high- and mid-dose groups, and increased kidney weights in the high-dose group; statisticallysignificant increased spleen weights were noted only in high-dose males. Liver to brain weight ratios were increased in all of the FM-3924 treated groups, but only in the high-dose groups was the change statisticallysignificant(p = <0.05). Uterine and testicle to brain weight ratios were slightly increased in the FM-3924 treated groups. Details of the histopathologicfindings are contained in Appendix Item D and a summary of the major neoplastic and non-neoplastic microscopic changes found after two years of continuous oral administration of FM-3924 are enumerated in Tables 19 and 20. Histopathologicevaluation of the tissues obtained from the animals necropsied at one year indicated the major FM-3924 effects were confined to the liver. Diffuse megalocytosis (ie. hypertrophy) and vacuolation of hepatocytes were the most common findings in essentially all of the male and female rats in the high-dose group. In addition, hepatocytic necrosis was found in 6/15 high-dose males, but was not seen in any of the high-dose females. The majority of neoplasms observed after two years of dosing with FM-3924 involved either the liver or one of several endocrine or endocrine-sensitiveorgans (see Table 19). Hepatocellular carcinomas were found in 6%, 4%, 2% and 2% of the male rats from the control, high-, midand low-dose groups, respectively. For the females, hepatocellular carcinomas and adenomas were found only in the high-dose group with incidence values of 6% and 8%, respectively. The organ with the largest incidence of tumors was the pituitary gland in which adenomas in the control animals were 35% for males and 72% for females. Sporadic increases in incidence for this neoplasm were noted primarily for the FM-3924 treated males; however, there did not appear to be any meaningful relationship of these to the dose administered. Mammary gland adenocarcinomas were present in both control and treated female rats at a level of 15%, 21%, 24% and 13% for the control, high-, mid- and low-dose groups, respectively. Similarly, fibroadenomas were seen in 22%, 13%, 33% and 36% of the female rats at the end of the study. Mammary gland adenomas (7%) and carcinomas (2%) were observed only in the 16. female controls. The incidenceof uterine polyps, benign growths of the endometrium,was slightly increased in the mid- and low-dose females. Likewise,there were minor variationsin the tumor incidencein the adrenal glands (ie. pheochromocytomas)and thyroids, both of which commonly exhibit spontaneoustumors in geriatricrats of this strain. Only the incidenceof C-cell carcinomasof the thyroid in female rats appeared to show a minimal dose dependent increase with an incidence of 0%, 4%, 3% and 2% for the control, high-, mid- and low-dose groups, respectively. However, in contrast, the male control animals showed a greater incidence of C-cell carcinomasthan any of the FM-3924 treated male groups (ie. 5%, 2%, 2% and 0%, respectively). Non-neoplastichistopathologicchanges at the end of the study were found in the adrenal,heart, kidney,liver, lung, testes,ovary, thyroid, urinary bladder and uterus (see Table 20). As noted in the one year interimhistopathologicevaluation,the liver was the primary target organ for FM-3924 relatedeffects,and there was a remarkableconsistencyin the type of findingsobservedafter the second full year of test article administrationat the high-dose level. Meg alocytosis and hepatocyte vacuolation(both findingsconsideredto be reversiblebiologicalevents) were the major changes seen in both males and females treated with the highest doses of FM-3924. Megalocytosiswas also found at an incidence exceeding 50% in the mid- and low-dose males, but was essentially absent from the corresponding female groups. Hepatocyte vacuolation was observed at an incidenceless than control values in the mid- and low-dosemale and female groups. Hepatic cystoid degeneration,a condition characterizedby areas of multilocularmicrocysts in the liver parenchyma,was seen at an incidence of 87*,30%, 16% and 12% in males from the control, high-, mid- and low-dose groups, respectively,while only the high-dosefemales were affected at an incidence of 87*. Hepatocellularnecrosis was found at an incidence of between 6-10% in the control animals of both sexes, but the high-dose males demonstratedan incidencerate for this lesion of 20%, with 0% and 4% in the mid- and low-dose groups, respectively. The incidenceof liver necrosis for females was 8%, 12% and 10% for the high to low treatment groups. Hyperplastic nodules, a localized proliferationof hepatic parenchymalcells, was observed essentiallyonly in the high-dose group 17. with an incidence of 10% in the males and 18% in the females as compared to 0% and 2% in the control male and female rats, respectively. The only other hyperplasticnodule seen was found in a mid-dose male animal. There was a statisticallysignificantand dose dependent increase in tubular hyperplasiaof the ovarian stroma of female rats. Tubular hyperplasiais a diffuse, non-neoplasticincrease in stromal tubular elementswhich is usually bilateraland associatedwith decreased or absent folliculardevelopment. The incidence of this change was 0%, 31%, 23% and 13% in the control, high-, mid- and low-dosegroups, respectively. Cystic glands of the uterineendometriumwere found at a higher incidence in the high-dose females (29%) when comparedto the control animals (14%). The incidence of nodular hyperplasiaof the adrenal cortex was significantlyincreasedin the high-dosemales. A statisticallysignificantincreased incidenceof foamy macrophage accumulationin the lung of the high-dosemale and female rats was considereda possibletest articleeffect. The remaining major non-neoplasticlesions (Table 20) and other histopathologicfindings (AppendixItem D) had varying incidenceseither similar to, increased, or decreased from control values; however, essentiallyall of these findingsare commonly associated with either endemic diseases and/or geriatric changes found in this strainof rat. The changes presented hereinafter were not consideredtest-articlerelated findings,althoughtheir incidencevaried from that observed in the control eats. In the lung, the incidencesof alveolar macrophages and vascular mineralizationwere increasedabove control levels while the incidenceof interstitialpneumoniawas essentiallyequal to or less than the control incidenceat the end of the study. Likewise,the characteristiclesionsof an endemic renal disease seen in old rats appeared to be somewhat diminished in the high-dose males and females. The incidences of adrenal gland changes, usually found in old rats, were inconsistent,being either higher or lower than the control values. The incidence of nodular hyperplasiaof the adrenal cortex was significantlyincreased in the high-dosemales; the incidenceof sinusoidalectasia was increased in the mid- and high-dosemales but decreased in the females of the same group; 18. and the incidenceof adrenal cortical vacuolationwas decreased in the treated males but generally increasedin the FM-3924 treated females. The incidence of chronic myocarditiswas reduced in a dose dependent fashion in the female rats while being increasedabove the control incidence in the mid- and low-dose males. Polyarteritis,a spontaneous lesion in the testes of old male rats, was found in this study in more control animals than in any of the FM-3924-treatedgroups. However, the incidenceof testicularvascularmineralizationwas increasedin the highand low-dose animals. The incidenceof epithelialhyperplasiaof the urinary bladder was decreasedin all of the FM-3924-treatedfemale groups, while there was an equivocal increase in the incidencefor the mid-dose male group only. Finally,the incidenceof thyroid C-cell hyperplasiawas moderately increased in both the male and female high- and mid-dose groups. 19. DISCUSSION The purpose of this study was to define any long term toxicity and to profile the potential oncogenicityof FM-3924, a perfluoroalkylsulfonamido alcohol used in a variety of industrial manufacturing processes. The results of the study included a series of biological events which when taken as separate findings may appear to confound test substance dose, sex and/or time relationships. However, considering an overview of all of these results, there appears to be a common pattern of test substance related effects which may be generalized as follows. The general well being of a rat exposed to the experimental conditions of a two 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 weights of the males decreased as early as the second week of the study. The females also showed a decrease, but the time of onset was delayed and the early body weight differences were not as pronounced as those seen in the males. This effect did not appear to be associatedwith decreased palatabilityof the diet due to the addition of test article since feed consumption based on weight of diet consumed versus body weight was actually increased. The possible effects that the apparent SDA viral infection might have had on body weight gains were considered, but discounted since the FM-3924 treated animals continued to show weekly increases in body weight despite the fact that the total gains were less than control gains. Since there was a dose and sex dependent change in this parameter, the decrease in body weight gain could be associated with a direct test article effect, possibly through varying degrees of altered hepatocellular metabolic activity as suggested by the microscopic hepatocellular changes observed in tissues obtained at both the one and two year necropsies. Regardless of this assumption, mortality rates were not obviously affected by the decreased body weight gains. The concentrationof the test substance in the diet was maintained during the full two years of the study at 10, 30 and 100 ppm for the low-, mid- and high-dose groups, respectively. The average daily dosage of FM-3924 for the same time period and for both sexes combined was estimated to be about 0.5, 1.5 and 5.0 mg/kg/day, respectively. Both in-life and postmortem results confirmed the systemic absorption of the test substance 20. and the 100 ppm dosage level appeared to adequately comply with the concept of a maximum tolerateddose for a long term study in this particularstrain of rat. The only clinical signs seen during the study which were suggestiveof a possible test article effect were ataxia and sporadic convulsions. The incidenceof convulsionswas increasedvery slightlyonly in the high-dose males, while ataxia was seen more frequentlyin both males and females of the FM-3924 treated groups as compared to control animals. These clinical signs were also seen in the control populationbut at a lower incidence. There were no cellular lesionsfound in the central or peripheralnervous system at the end of the study which could support a treatment related effect. In the high-dose females there was an apparent decrease in hemoglobin;. however, these values were within the normal ranges for this laboratory. There were no other meaningful compound-related effects on the hematologic parameters. Elevation of serum alkaline phosphatase, aspartate aminotransferase and alanine aminotransferaseactivities,primarily in the FM-3924 treated male rats, suggested the presence of hepatocellularalterations. Most of the increasesin enzyme activitywere more pronouncedin the earlier phases of the study, subsequentlyresolved in the mid- and low-dose males, and persisted in the high-dosegroup until the end of the study. The mean values in the mid- and low-dose groups from which these observationswere derived were influenced commonly by only one or two animals with aberrant serum enzyme activities. However, there was no meaningful exacerbation of the liver changeseven into the geriatricperiod of the rat's life span. These findings were substantiatedby the organ weight and histopathologic comparisons obtained at the one and two year necropsies. Mean blood urea nitrogen values were elevated in the male FM-3924 treated groups at three months, but not thereafter. If there were alterationsin kidneyfunctionat that time, they did not persistuntilthe end of the study since there was a decrease in the incidenceof chronic nephropathy in the FM-3924 treated males at two years when compared with control males. I Changes in the quality or characterof the urine specimensfrom both control and FM-3924 treated rats demonstrateda change in several urinary 21. parametersthat were progressiveover time. These findings were considered to be associatedwith the progressivedegenerativechanges of naturally occurringchronic renal diseasecommonly found in rats of this strain. The primary test articleeffect occurred in the liver as increased organ weight (both absoluteand relative),as gross findings at necropsy, and as histopathologicalterations. These changes were observedat the one year necropsy, but showed remarkablylittle progressionone year later at the two year necropsy. The high-dose males and females had essentially equal incidencesof hepatic findings,while the mid- and low-dose males were more markedly affected than were the females from the corresponding dose groups. Hepatomegalocytosisand hepatocellularvacuolationare characteristic of increasedmetabolicactivityin the rat. lesions may progress to cystoid It is recognizedthat these hepatocellularnecrosis. degeneration and, ultimately, The incidenceof hepatic necrosis in this study was slightlyincreasedonly in the high-dosemales. Since the liver in the rat rarely repairsparenchymalcell loss with fibrosisor scar tissue, a more typical cellular reaction is hepatocellularhyperplasia. In this study, the incidenceof hyperplasticnodules were increasedonl in the high-dose male and female animals (ie., 10% and 18%, respectively)ycompared to the controlgroups (ie. 0% and 2%, respectively). It is importantto note that no proliferativehepaticlesions (ie. hyperplasianor neoplasia) were seen in any of the high-doserats after receiving FM-3924 for one year. Primary liver neoplasms observed in this study after two years consisted of hepatocellularadenomas and carcinomas. The overall incidence of these neoplasmswas low, with carcinomasoccurring in both the control and FM-3924 treated groups as follows: males 6%, 4%, 2% and 2%; and females 0%, 6% 0% and 0% for the control, high-, mid- and respectively. low-dose groups, Benign hepatic neoplasms (ie. adenomas) were not found in any group except the high-dose females where an incidence of 8% was recorded. Consideringthe chronic liver stimulationnoted in both the high-dosemale and female groups during their life span, the incidenceof hepatic neoplasiaappears to be within reasonablelimits with the possible exception of the high-dose female group. Combined malignant and benign incidencevalues are within reasonablehistoricalcontrollimits for the 22. high-dosemales while the high-dose females appear to be slightly outside these limits only because there were no liver tumors seen in the control group. Based on these findings,FM-3924was not consideredto be a hepatic carcinogenin the rat. Most of the neoplasmsobserved in this study originatedfrom endocrine or endocrine-sensitiveorgans including the adrenal glands, mammary gland, pituitary,thyroidand uterus. These are common sites for spontaneous or naturallyoccurringoncogenesisin this strain of rat as evidencedby the specifictumor incidencein the controlgroup (see Table 19). Deviations from the control incidencefor these neoplasms were neither numerically meaningful nor did they involve a unique tumor type not commonly seen in this strainof rat. The non-neoplastic findings reported from the histopathologic evaluationof all of the animals scheduledfor the two year necropsywere mostlygeriatriclesionstypicalfor this strain of rat. The organs in which these lesions were found included adrenal glands, heart, kidneys, lung, testes, ovaries,thyroid, urinary bladder and uterus. Specific deviations from the control incidenceseen in FM-3924 treated groups were addressedin the resultssectionof this report. However, the following changes were considered equivocal test article related effects. The incidenceof nodular hyperplasiaof the adrenalcortex was significantly increased (22%) in the high-dose males compared to the same findingin the controls (4%), while the high-dose female rats showed a much lower incidence (2%). Lung changes were also sporadic in occurrencewith the incidencesof the accumulation of alveolar macrophages increased in the high-dose males and females. The incidenceof ovarian (stromal)tubular hyperplasiawas increased in a statisticallysignificantand dose dependent manner. The interpretationof this findingis uncertain,but a possibleexplanationis that it was secondary to the hepatic changes which may evoke endocrine relatedeffectsin older rats. Likewise,the increase in uterine cystic glands in the high-dosefemalescould be a manifestationof this biological phenomenon. 23. CONCLUSIONS The pertinentfindingsafter administeringFM-3924to rats in the diet at concentrationsof 0, 10, 30 and 100 ppm for up to two years under the conditions of this study may be summarizedas follows: 1. FM-3924 related hematologic changes were seen in the high-dose female rats only and consisted of a decrease in hemoglobin concentration,and in hematocritvalues with some evidence of altered red blood cell morphologyin blood smears obtainedat the end of the study. While the decrease in hemogram values was observedvery early in the study, it did not progressinto anemia by the end of the two year dosing period. 2. Increased liver weights and microscopic findings including hepatomegalocytosisw,hich was considered to be the result of chronic hepatocellularmetabolic stimulation by FM-3924, and hepatocellulardegenerationwith and without necrosis,were the primary dose-relatedtoxicologicfindingsobserved in this study. These liver changes were seen at the one year necropsy, but showed very little evidenceof progressionduring the study. 3. The non-neoplasticfindings observed in this study were not consideredto be primary test article related effects,but were believed to be related to hepatocellulareffects and/or were associatedwith a mild exacerbationof anticipatedgeriatric endocrinelesionsin this strainof rat. Specifichistopathology findingswhich had an equivocalrelationshipto treatmentwith FM-3924 included a statisticallysignificant, dose-related increase in ovarian tubular hyperplasiaobserved with the female rat groups. Other findings were consideredto be spontaneousin origin, and occurred either sporadicallyor at a generally similar incidenceamong all groups includingcontrols. 24. 4. The no observed adverse effect level (NOAEL) feed concentration was judged to be greater than 30 but less than 100 ppm of FM-3924 in the diet. Based on feed consumption data, these NOAEL concentrations corresponded to approximate average daily doses for both sexes of 1.5 and 5.0 milligramsper kilogram of body weight, respectively. 5. The overall incidence of hepatocellularadenomas and carcinomas was low in both control and FM-3924 exposed groups with only the high-dose female rats possibly having a tumor incidence outside historicalcontrollimits. The majority of neoplasms observed originated from endocrineor endocrine-sensitiveorgans which are typicalneoplasticsites for older rats of this strain. The incidence of these neoplasms was similar among control and treated groups, and did not demonstrate a unique tumor type. 6. Based on the incidenceand types of neoplasms, time of onset of tumor appearance, malignancy patterns of tumors found at two years and the final mortalityvalues, FM-3924was not considered to be carcinogenicin the rat. 25. PRINCIPALPERSONNELINVOLVEDWITH THE CONDUCTAND REPORTINGOF RIKEREXPERIMENTNO. 0281CROO12- TWO YEAR ORAL (DIET) TOXICITY/CARCINOGENICSITTUYDYOF FLUOROCHEMICAFLC-143IN 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 LaboratoryTechnician/ Study Assistant External Consultant/Draft Report Preparation Senior Medical Technologist/ Clinical Pathology Determinations Advanced Secretary/ Report Typing Advanced Biostatistician Toxicology Specialist/Sponsor Representativeand Project Coordinator Histotechnologist/Microscope Slide Preparation Supervisor, Laboratory Animal Care Laboratory Technician Senior LaboratoryTechnician/ Assisted With Study Data 26. SIGNATURE PAGE TWO YEAR ORAL (DIET) TOXICITYICARCINOGENICITY STUDY OF FLUOROCHENICAL FN-3924 IN RATS RIKER Experiment No. 0281CROO12 From the Pathology and Toxicology Department RIKER Laboratories, Inc./3M Company St. Paul, Minnesota U.S.A. Study Director: Leonard J. SMinski, B.A. Date Senior Toxicologist Report Reviewed By: Jai6esL. Allen, Ph.D. Date Diplomate, A.B.T. Research Toxicologist Report Approved By:@@0-a Q@ Edward JYtErickson, Ph.D. Date Laboratory Manager Report Reviewed By: Steve V. Elrod, Ph.D. Date Diplomate, A.B.T. Manager, Pathology/Toxicologyand Laboratory Animal Medicine 27. Table I Two Year oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon FM-3924 in Rats Analytical Analysis of PM-3924a(%.Above/Below Desired Concentration) Approximate Study Month CCD Analytical Report Numbers Dosage 200 Diet 100 Concentrate Levels (ppm) 30 0 (Initial) 213 + 7.0% + 7.0% - 4.3% 1 229 + 4.0% + 4.0% + 0.0% 4 251 + 7.0% +10.0% + 2.2% 7 290 + 8.5% + 5.0% - 1.0% 10 320 - 1.0% + 5.3% - 6.7% 11 327 - - 13 341 - 0.5% 1.3% - 3.3% 16 367 - 3.5% -19.3% - 4.4% 16 368 - + 3.3% - 19 383 +11.5% + 7.3% +11.0% 22 394 -16.5% - 8.0% -10.0% 24 403 + 4.0% + 1.0% - 2.0% 10 + 0.0% + 9.0% + 7.0% - 3.0% -21.7% + 0.7% +11.0% + 6.7% +13.0% -17.0% -13.0% Mean Deviation for the study + 2.0% + 3.4% - 1.8% + 1.4% a Co--rcial Chemicals Division (CCD) @@Incorrect values given at this level due to instrument malfunction; this dosage level was reanalyzed after now detector was installed. c -@-Incorrect values given possibly due to a variation in analytical procedure; percentage near lower acceptable limit, this dosage level reanalyzed (two weeks later). d Excluding from mean deviation the percentages near + 20% acceptable limit. 28. Table 2 Two Year Oral (Diet) Toxicity-oncogenicity Study of Fluorocarbon FM-3924 in Rats Summary of Mean Body Weights (g) + % Difference from Control 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 Mean Wt. 100 ppm Mean Wt. % Diff. 165.3 270.9 334.0 390.7 429.2 456.2 475.5 493.2 502.9 515.3 526.8 542.3 550.4 561.0 567.5 576.3 580.6 582.9 591.0 599.4 608.4 612.9 619.8 623.5 626.1 639.2 638.6 168.2 253.6 308.7 333.1 369.8 397.2 '417.1 425.5 442.4 452.7 465.0 474.6 483.7 489.0 500.1 510.5 515.9 507.1 518.8 524.9 530.4 536.5 541.7 548.8 552.3 559.9 566.7 + 1.8 - 6.4 - 7.6 -14.7 -13.8 -12.9 -12.3 -13.7 -12.0 -12.2 -11.7 -12.4 -12.1 -12.8 -11.9 -11.4 -11.1 -13.0 -12.2 -12.4 -12.8 -12.4 -12.6 -12.0 -11.8 -12.4 -11.2 30 ppm Mean Wt. % Diff. 169.1 262.8 327.7 361.6 404.8 433.8 454.8 464.7 485.0 495.0 508.9 522.5 532.1 541.4 552.4 561.3 569.2 567.1 576.8 578.2 586.8 592.0 598.8 604.8 611.0 619.1 623.8 +2.3 -3.0 -1.9 -7.4 -5.7 -4.9 -4.4 -5.6 -3.6 -3.9 -3.4 -3.6 -3.3 -5.5 -2.7 -2.6 -2.0 -2.7 -2.4 -3.5 -3.6 -3.4 -3.4 -3.0 -2.4 -3.1 -2.3 10 ppm Mean Wt. % Diff. 165.6 258.3 321.3 355.3 394.5 428.3 453.2 466.2 484.2 495.0 508.0 521.1 531.9 541.1 553.0 561.9 570.1 566.3 575.8 578.0 588.7 590.7 595.9 601.3 605.2 614.1 618.1 0 -4.6 -3.8 -9.1 -8.1 -6.1 -4.7 -5.5 -3.7 -3.9 -3.6 -3.9 -3.4 -3.5 -2.6 -2.5 -1.8 -2.8 -2.6 -3.6 -3.2 -3.6 -3.9 -3.6 -3.3 -3.9 -3.2 29. Table 2 (concluded) Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Summary of Mean Body Weights (g) + % Difference from Control 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 Mean Wt. 100 ppm Mean Wt. % Diff. 654.3 661.6 668.0 673.2 674.4 664.5 650.8 656.6 661.9 658.3 660.8 667.7 668.8 670.6 663.1 668.1 675.6 678.9 690.0 686.0 678.3 677.5 675.7 671.1 665.9 642.0 573.4 579.0 583.6 584.5 589.2 589.5 591.0 592.9 601.2 592.1 588.1 600.2 598.9 607.2 602.6 612.3 610.2 613.4 617.7 610.9 595.3 592.6 594.2 594.7 588.8 568.6 -12.4 -12.5 -12.6 -13.2 -12.6 -11.3 - 9.2 - 9.7 - 9.2 -10.1 -11.0 -10.1 -10.5 - 9.5 - 9.1 - 8.4 - 9.7 - 9.6 -10.5 -10.9 -12.2 -12.5 -12.1 -11.4 -11.6 -11.4 30 ppm Mean Wt. % Diff. 627.3 633.5 634.6 637.3 640.3 641.7 644.7 646.2 650.5 640.5 638.7 651.9 654.8 656.5 657.5 657.3 653.4 648.2 646.9 644.7 634.3 630.9 627.6 630.0 629.0 628.9 -4.1 -4.2 -5.0 -5.3 -5.1 -3.4 -0.9 -1.6 -1.7 -2.7 -3.3 -2.4 -2.1 -2.1 -0.8 -1.6 -3.3 -4.5 -6.2 -6.0 -6.5 -6.9 -7.1 -6.1 -5.5 -2.0 10 ppm Mean Wt. % Diff. 620.7 625.7 635.2 639.4 641.2 642.8 646.0 650.6 650.5 642.9 641.6 648.3 650.6 652.5 648.8 648.9 653.4 655.9 656.8 655.4 657.3 651.1 649.2 642.1 651.1 645.6 -5.1 -5.4 -4.9 -5.0 -4.9 -3.3 -0.7 -9.1 -1.7 -2.3 -2.9 -2.9. -2.7 -2.7 -2.2 -2.9 -3.3 -3.4 -4.8 -4.5 -3.1 -3.9 -3.9 -4.3 -2.2 +0.6 30. Table 3 Two Y*ar oral (Ditt) Toxicity-Oncogenicity Study of Fluorocarbon PM-3924 in Rats Summary of Mean Body Weights (g) + t Difference from Control FEMALES 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 50 52 Control M*an Wt. 100 ppm Mean Wt. % Diff. 138.2 159.2 209.5 238.7 256.9 269.2 279.5 289.7 291.8 306.8 311.6 319.1 324.5 327.3 333.7 338.3 345.5 350.7 355.5 359.3 363.2 371.2 380.1 385.7 392.3 398.6 406.1 138.7 168.5 211.4 224.6 237.7 243.2 241.6 251.1 256.9 263.2 269.4 273.2 278.1 279.9 285.0 282.2 289.8 292.1 300.5 302.1 306.3 311.4 313.9 317.8 321.1 324.6 328.8 + 0.4 + 5.8 + 0.9 - 6.0 - 7.4 - 9.7 -13.6 -13.3 -12.0 -14.2 -13.5 -14.4 -14.3 -14.5 -14.6 -16.6 -16.1 -16.7 -15.4 -15.9 -15.7 -16.1 -17.4 -17.6 -18.1 -18.6 -19.0 30 ppm Mean Wt. % Diff. 135.8 163.3 213.6 234.3 252.0 261.6 264.4 275.0 283.4 292.3 299.3 303.5 310.3 312.9 321.7 318.6 325.7 331.6 337.8 341.5 345.4 353.7 358.3 363.8 368.6 373.9 379.3 -1.7 +2.6 +2.0 -1.8 -2.0 -2.8 -5.4 -5.1 -2.9 -4.7 -3.9 -4.9 -4.4 -4.4 -3.6 -5.8 -5.7 -5.4 -5.0 -5.0 -4.9 -4.7 -6.0 -5.7 -6.0 -6.2 -6.6 10 ppm Moan Wt. % Diff. 135.6 158.3 211.0 237.9 256.8 260.8 270.4 283.2 291.7 301.8 308.0 317.0 323.1 327.7 332.5 332.7 337.6 342.1 351.6 358.3 359.6 369.3 376.3 379.6 386.9 391.3 400.5 -1.9 -0.6 +0.7 -0.3 0.0 -3.1 -3.3 -2.2 0.0 -1.6 -1.2 -0.7 -0.4 +0.1 -0.4 -1.7 -2.3 -2.4 -1.1 -0.3 -1.0 -0.5 -1.0 -1.6 -1.4 -1.8 -1.4 31. Table 3 (concluded) Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 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 88 90 92 94 96 98 100 102 104 Control Mean Wt. 100 ppm Mean Wt. % Diff. 414.1 419.1 420.9 423.6 426.6 426.1 424.9 427.5 431.4 435.2 446.5 455.2 464.8 474.9 484.0 484.8 492.7 499.1 500.6 512.5 505.7 506.9 500.0 501.2 503.6 502.0 334.2 340.9 346.9 350.0 351.0 351.8 350.4 357.7 360.8 366.4 371.4 373.4 369.3 378.7 378.2 383.9 378.3 389.7 389.7 392.6 399.1 402.6 402.6 396.9 402.3 397.8 -19.3 -18.7 -17.6 -17.4 -17.7 -17.4 -17.5 -19.5 -16.4 -15.8 -16.8 -18.0 -20.5 -20.3 -21.9 -20.8 -23.2 -21.9 -22.2 -23.4 -21.1 -20.6 -19.5 -20.8 -20.1 -20.8 30 ppm Mean Wt. % Diff. 388.0 396.0 404.1 408.0 411.5 416.5 413.7 422.4 423.5 429.9 435.1 442.1 438.3 444.9 436.4 443.8 443.9 445.5 442.1 448.9 440.1 445.6 444.9 435.5 438.6 425.2 -6.3 -5.5 -4.0 -3.7 -3.5 -2.3 -2.6 -1.2 -1.s -1.2 -2.6 -2.9 -5.7 -6.3 -9.8 -8.5 -9.9 -10.7 -11.7 -12.4 -13.0 -12.1 -11.0 -13.1 -12.9 -15.3 10 ppm Mean Wt. % Diff. 407.6 412.6 421.8 423.9 425.6 429.0 425.5 434.7 440.6 449.9 455.9 458.2 458.7 466.9 467.1 475.7 490.2 486.9 494.6 487.1 486.1 499.3 494.6 492.1 490.4 484.5 -1.6 -1.6 +0.2 0.0 -0.2 +0.7 +0.1 +1.7 +2.1 +3.4 +2.1 +0.7 -1.3 -1.7 -3.5 -1.9 -0.5 -2.4 -1.2 -5.0 -3.9 -1.5 -1.1 -1.8 -2.6 -3.5 32. Table 4 Two Year Oral (Diet) Toxicity-Oncogenicity of Fluorocarbon FM-3924 in Rats Study Summary of Mean Food Consumption Per Kilogram Body Weight (g 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. 100 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 36.5 100.7 89.4 74.5 62.7 65.4 60.2 55.8 51.3 52.3 50.1 50.8 50.1 47.4 45.4 47.3 45.0 43.2 41.4 44.8 44.5 44.3 45.7 45.0 43.4 42.7 42.5 40.6 - 1.3 + 4.9 - 2.5 - 9.7 + 6.3 +12.1 +10.1 - 0.8 + 9.0 + 7.1 + 8.3 +11.6 + 5.3 + 3.9 +10.5 + 4.2 + 0.7 - 1.0 +16.7 + 9.3 +12.2 +16.3 +15.7 +11.3 + 9.5 +10.4 +11.2 30 ppm Mean Wt. % Diff. 100.9 90.2 77.4 65.4 65.0 60.2 58.7 51.2 50.1 49.0 49.1 49.5 46.3 44.0 45.0 43.9 42.2 39.8 42.9 42.5 43.1 45.4 42.6 42.3 41.7 40.7 38.2 - 1.1 + 5.9 + 1.3 - 5.8 + 5.7 +12.1 +15.8 - 1.0 + 4.4 + 4.7 + 4.7 +10.2 + 2.9 + 0.7 + 5.1 + 1.6 + 1.6 - 4.8 +11.7 + 4.4 + 9.1 +15.5 + 9.5 + 8.5 + 6.9 + 5.7 + 4.7 10 ppm Mean Wt. % Diff. 102.4 91.5 77.4 63.3 64.3 60.8 55.7 51.1 50.9 48.9 49.0 48.5 46.3 42.6 43.2 43.1 41.5 38.6 42.4 42.7 42.6 43.9 41.8 40.9 41.3 40.2 32.8 + 0.4 + 7.4 + 1.3 - 8.8 + 4.6 +13.2 + 9.9 - 1.2 + 6.0 + 4.5 + 4.5 + 8.0 + 2.9. - 2.5 + 0.9 + 0.2 - 3.3 - 7.7 +10.4 + 4.9 + 7.9 +11.7 + 7.5 + 4.9 + 5.9 + 4.4 -10.1 33. Table 4 (concluded) Two Year Oral (Diet) Toxicity-Oncogenicity of Fluorocarbon FM-3924 in Rats Study Summary of Mean Food Consumption Per Kilogram Body Weight (g of diet consumed per day) + % Difference from Control 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 Mean Wt. 100 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 41.9 41.1 41.0 40.4 40.1 41.4 36.2 37.1 40.1 40.9 41.8 40.7 37.6 39.5 40.2 34.8 40.3 41.1 39.3 39.5 40.7 41.5 41.4 41.9 40.9 39.0 +13.2 +12.3 +13.6 +14.1 +11.7 +33.6 - 0.3 +12.8 +23.0 +23.9 +21.5 + 9.7 + 2.7 +14.2 +10.7 - 2.3 +14.8 +18.1 +12.6 +12.5 + 5.7 +11.9 +11.0 +14.2 +16.9 +15.4 30 ppm Mean Wt. % Diff. 40.2 39.8 39.7 39.1 38.4 39.6 34.3 35.3 37.7 38.7 40.1 39.4 36.5 37.5 36.4 33.3 41.6 39.2 38.5 39.7 40.7 40.6 39.4 40.3 39.9 38.5 + 8.7 + 8.7 + 1.7 +10.5 + 7.0 +27.7 - 5.5 + 7.3 +15.6 +17.3 +16.6 + 6.2 - 0.3 + 8.4 + 0.3 - 6.5 +18.5 +12.6 +10.3 +13.1 + 5.7 + 9.4 + 5.6 + 9.8 +14.0 +13.9 10 ppm Mean Wt. % Diff. 39.2 38.4 39.2 38.5 38.7 39.2 34.4 35.7 36.4 38.1 40.7 38.7 37.2 38.2 37.0 33.6 39.6 39.2 39.3 38.6 40.0 37.0 39.4 40.0 40.6 37.8 + 6.0 + 4.9 + 8.6 + 8.8 + 7.8 +26.5 - 5.2 + 8.5 +11.7 +15.5 +18.3 + 4.3 + 1.6 +10.4 + 1.9 - 5.6 +12.8 +12.6 +12.6 +10.0 + 3.9 - 0.3 + 5.6 + 9.0 +16.0 +11.8 34. Table 5 Two Year oral (Diet) Toxicity-Oncogenicity of Fluorocarbon FM-3924 in Rats Study Summary of Mean Food Consumption Per Kilogram of Body Weight (g of diet consumed per day) + % Difference from Control FEMALES 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. 100 ppm 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 96.4 101.3 80.3 73.6 74.8 70.9 67.0 64.0 63.1 66.3 .64.1 61.9 60.4 58.5 58.6 57.2 58.1 53.1 59.2 58.6 60.1 57.5 55.4 54.1 53.6 49.6 53.2 2.4 5.3 -17.4 - 9.1 + 0.9 - 2.3 - 4.6 - 0.3 +10.3 + 3.1 + 1.1 + 5.6 + 1.5 + 2.6 - 5.0 - 4.2 - 0.5 + 0.4 + 4.4 + 3.2 + 2.9 + 6.1 + 1.3 +11.6 + 8.9 - 3.5 +10.1 30 ppm Mean Wt. % Diff. 98.2 102.9 82.9 79.0 72.3 70.4 67.0 66.7 64.3 65.8 66.2 61.5 60.6 57.4 55.9 53.5 55.4 49.5 56.5 55.6 57.6 53.4 53.0 52.5 55.3 50.8 49.8 - 0.6 - 3.8 -14.7 - 2.5 - 2.4 - 3.0 - 4.6 + 3.9 +12.4 + 2.3 + 4.4 + 5.0 + 1.9 + 0.7 - 9.4 -10.4 - 5.1 - 6.4 - 0.4 - 2.1 - 1.4 - 1.5 - 3.1 + 8.3 +12.4 + 3.1 10 ppm Mean Wt. % Diff. 99.6 106.2 93.1 85.3 78.2 81.7 71.4 69.3 63.9 67.0 65.9 61.2 58.5 56.0 57.7 55.2 56.4 50.5 58.9 57.2 59.0 56.3 53.4 50.8 52.0 51.6 49.4 + 0.8 - 0.8 - 4.2 + 5.3 + 5.5 +12.5 + 1.7 + 7.9 +11.7 + 4.2 + 3.9 + 4.4 - 1.7 - 1.8 - 6.5 - 7.5 - 3.4 - 4.5 + 3.9 + 0.7 + 1.0 + 3.9 - 2.4 + 4.7 + 5.7 + 0.4 + 2.3 35. Table 5 (concluded) Two Year Oral (Diet) Toxicity-oncogenicity Study of Fluorocarbon PM-3924 in Rats Summary of Mean Food Consumption Per Kilogram'of Body Weight (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 88 90 92 94 96 98 100 102 104 Control Mean Wt. 100 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 54.2 53.7 51.3 50.9 51.0 45.5 45.1 52.0 52.7 53.2 51.4 48.2 55.0 48.3 45.0 47.9 48.4 50.6 48.2 50.4 51.4 53.7 51.7 51.9 48.5 46.8 +12.7 + 4.3 +10.8 + 2.6 + 8.3 - 6.0 +10.0 +15.8 +14.3 +17.4 + 6.2 - 0.2 +24.7 + 5.7 + 2.3 +10.1 + 9.3 +11.7 + 4.6 + 9.8 + 9.6 +26.7 +10.5 +25.1 +14.1 +12.5 30 ppm Mean Wt. % Diff. 50.0 49.5 46.3 46.8 46.7 41.8 40.1 48.3 49.1 49.3 46.-0 45.5 47.2 45.4 42.4 46.6 46.6 48.7 48.9 49.9 51.4 54.1 56.4 56.3 57.5 52.5 + 4.0 - 3.9 0 - 5.7 - 0.9 -13.6 - 2.2 + 7.8 + 6.5 + 8.8 - 5.0 - 5.8 + 7.0 - 0.7 - 3.6 + 7.1 + 5.2 + 7.5 + 6.1 + 8.7 + 9.6 +27.6 +20.5 +35.7 +35.3 +26.2 10 ppm Mean Wt. % Diff. 50.1 50.4 45.8 46.0 46.1 41.7 38.1 44.2 45.9 51.6 46.5 41.0 44.5 39.6 45.0 43.9 44.9 42.7 43.5 42.5 46.3 47.1 44.5 52.4 46.5 40.5 + 4.2 - 2.1 - 1.1 - 7.3 - 2.1 -13.8 - 7.1 - 1.6 - 0.4 +13.9 - 3.9 -15.1 + o.g -13.4 + 2.3 + 0.9 + 1.4 - 5.7 - 5.6 - 7.4 - 1.3 +11.1 - 4.9 +26.3 + 9.4 - 2.6 36. Study Week 1 2 4 6 8 10 12 14 16 is 20 22 24 26 26 30 32 34 36 38 40 42 44 46 48 50 52 Table 6 Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Summary of mean Food ConsuEption - Absolute (g/rat/day) + % Difference from Control MALES Control Mean Wt. 100 ppm Mean Wt. Diff. 30 ppm Mean Wt. % Diff. 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 21.8 22.7 23.0 20.9 24.2 23.9 23.3 21.8 23.2 22.7 23.6 23.8 22.9 22.2 23.6 23.0 22.3 21.0 23.2 23.4 23.5 24.5 24.4 23.7 23.6 23.8 23.0 1.8 1.7 9.8 -22.9 - 8.3 - 2.5 - 3.3 -14.5 - 3.7 - 5.8 - 4.5 - 2.1 - 7.7 - 9.4 - 2.9 - 7.6 -10.4 -13.6 + 2.2 - 4.1 - 2.1 + 1.7 + 1.2 - 2.1 - 3.3 - 3.3 - 1.3 22.4 23.7 25.3 23.6 26.3 26.1 26.7 23.8 24.3 24.2 25.0 25.9 24.7 23.8 24.9 24.6 24.0 22.6 24.8 24.6 25.3 26.9 25.5 25.6 25.5 25.2 23.8 + 0.9 + 2.6 - 0.8 -12.9 - 0.4 + 6.5 +10.8 - 6.7 + 0.8 + 0.4 + 1.2 + 6.6 - 0.4 - 2.9 + 2.5 - 1.2 - 3.6 - 7.0 + 9.3 + 0.8 + 5.4 +11.6 + 5.8 + 5.4 + 4.5 + 2.4 + 2.2 10 ppo Mean Wt. % Diff. 22.2 23.6 24.9 22.5 25.4 26.0 25.3 23.8 24.7 24.2 24.9 25.3 24.6 23.0 23.9 24.2 23.7 21.9 24.4 24.7 25.1 25.9 24.9 24.6 25.0 24.7 20.3 + 0.0 + 2.2 - 2.4 -17.0 - 3.8 + 6.1 + 5.0 - 6.7 + 2.5 + 0.4 + 0.8 + 4.1 + 0.8 - 6.1 - 1.7 - 2.8 - 4.8 - 9.9 + 7.5 + 1.2 + 4.6 + 7.5 + 3.3 + 1.2 + 2.5 + 0.4 -12.9 37. 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 (concluded) Two Year oral (Diet) ToxiCity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Summary of Mean Food Consumption - Absolute (g/rat/day) + % Difference from Control MALES Control Mean Wt. 100 ppm Mean Wt. % Diff. 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 24.0 23.8 23.9 23.6 23.6 24.4 21.4 22.0 24.1 24.2 24.6 24.4 22.5 24.0 24.2 21.3 24.6 25.2 24.3 24.1 24.2 24.6 24.6 24.9 24.1 22.2 - 0.8 - 1.7 - 0.8 - 0.8 - 2.5 +18.4 - 9.3 + 1.9 +11.6 +11.5 + 8.4 - 1.6 - 8.2 + 3.5 + 0.4 -10.5 + 3.8 + 6.8 + 0.8 + 0.0 7.3 2.0 2.4 + 1.2 + 3.4 + 2.3 30 ppm Mean Wt. % Diff. 25.2 25.2 25.2 24.9 24.6 25.4 22.1 22.8 24.5 24.8 25.6 25.7 23.9 24.6 23.9 21.9 27.2 25.4 24.9 25.6 25.8 25.6 24.7 25.4 25.1 24.2 + 4.1 + 4.1 + 4.6 + 4.6 + 1.7 +23.3 - 6.4 + 5.6 +13.4 +14.3 +12.8 + 3.6 - 2.5 + 6.0 - 0.8 - 8.0 +14.8 + 7.6 + 3.3 + 6.2 - 1.2 + 2.0 - 2.0 + 3.3 + 7.7 +11.5 10 ppm Mean Wt. % Diff. 24.3 24.0 24.9 24.6 24.8 25.2 22.2 23.2 23.7 24.5 26.1 25.1 24.2 24.9 24.0 21.8 25.9 25.7 25.8 25.3 26.3 24.1 25.6 25.7 26.4 24.4 + 0.4 - 0.8 + 3.3 + 3.4 + 2.5 +22.3 - 5.9 + 7.4 + 9.7 +12.9 +15.0 + 1.2. - 1.2 + 7.3 - 0.4 - 8.4 + 9.3 + 8.9 + 7.1 + 5.0 + 0.8 - 4.0 + 1.6 + 4.5 +13.3 +12.4 38. 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 Table 7 Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Summary of Mean Food Consuimption - Absolute (g/rat/day) + % Difference from Control FEMALES Control Mean Wt. 100 ppm Mean Wt. % Diff. 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 14.0 17.1 17.0 16.5 17.8 17.2 16.2 16.1 16.2 17.4 17.3 16.9 16.8 16.4 16.7 16.2 16.8 15.5 17.8 17.7 18.4 17.9 17.4 17.2 17.2 16.1 17.5 + 3.7 + 0.6 -16.7 -14.5 - 6.3 -11.8 -17.4 -13.4 - 3.0 -11.7 -12.6 - 9.6 -13.0 -12.3 -18.9 -19.8 -16.8 -16.2 -11.9 -13.2 -13.2 -11.0 -16.4 - 8.0 -10.9 -21.5 -10.7 30 ppm Mean Wt. % Diff. 13.9 16.8 17.7 18.5 18.2 18.4 17.7 18.3 18.2 19.2 19.8 18.7 18.8 18.0 18.0 17.0 18.0 16.4 19.1 19.0 19.9 18.9 19.0 19.1 20.4 19.0 18.9 + 3.0 - 1.2 -13.2 - 4.2 - 4.2 - 5.6 - 9.7 - 1.6 + 9.0 - 2.5 + 0.0 + 0.0 - 2.6 - 3.7 -12.6 -15.8 -10.9 -11.4 - 5.5 - 6.9 - 6.1 - 6.0 - 8.7 + 2.1 + 5.7 - 7.3 - 3.6 10 ppm Mean Wt. 13.9 16.8 19.6 20.3 20.1 21.3 19.3 19.6 18.7 20.2 20.3 19.4 18.9 18.3 19.2 18.4 19.0 17.3 20.7 20.5 21.2 20.8 20.1 19.3 20.1 20.2 19.8 % Diff. + 3.0 - 1.2 - 3.9 + 5.2 + 5.8 + 9.2 - 1.5 + 5.4 +12.0 + 2.5 + 2.5 + 3.7 - 2.1 - 2.1 - 6.8 - 8.9 - 5.9 - 6.5 + 2.5 + 0.5 + 0.0 + 3.5 - 3.4 + 3.2 + 4.2 - 1.5 + 1.0 39. 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 (concluded) Two Year oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon PM-3924 in Rats Summary of Mean Food Consuuption - 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 20.9 100 ppm Mean Wt. 18.1 18.3 17.8 17.8 17.9 16.0 15.8 18.6 19.0 19.5 19.1 18.0 20.3 18.3 17.0 18.4 18.3 19.7 18.8 19.8 20.5 21.6 20.8 20.6 19.5 18.6 Diff. 9.1 -15.3 - 8.7 -15.2 -11.0 -22.3 - 9.2 - 3.1 - 4.5 - 1.0 -11.6 -18.2 - 1.0 -15.7 -20.2 -12.8 -16.1 -12.8 -18.6 -15.7 -13.5 + 0.5 -11.1 - 1.0 - 8.9 -11.0 30 ppm Mean Wt. % Diff. 19.4 19.6 18.7 19.1 19.2 17.4 16.6 20.4 20.8 21.2 20.0 20.1 20.7 20.2 18.5 20.7 20.7 21.7 21.6 22.4 22.6 24.1 25.1 24.5 25.2 22.3 - 2.5 - 9.3 - 4.1 - 9.1 - 4.5 -15.5 - 4.6 + 6.3 + 4.5 + 7.6 - 7.4 - 8.6 + 1.0 - 6.9 -13.2 - 1.9 - 5.1 - 4.0 - 6.5 - 4.7 - 4.6 +12.1 + 6.8 +17.8 +17.8 + 6.7 10 ppm Mean Wt. % Diff. 20.4 20.8 19.3 19.5 19.6 17.9 16.2 19.2 20.2 23.2 21.2 18.8 20.4 18.5 21.0 20.9 22.0 20.8 21.5 20.7 22.5 23.5 22.0 25.8 22.8 19.6 + 2.5 - 3.7 - 1.0 - 7.1 - 2.5 -13.1 - 6.9 + 0.0 + 1.5 +17.8 - 1.9 -14.6 - 0.5 -14.8 - 1.4 - 1.0 + 0.9 - 8.0 - 6.9 -11.9 - 5.1 + 9.3 - 6.0 +24.0 + 6.5 6.2 40. 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 54 56 58 60 62 64 66 68 70 Table Estimated Mean PM-3924 (mg/kg) Consumption Per Day 100 ppm Male Female 10.1 8.9 7.5 6.3 6.5 6.0 5.6 5.1 5.2 5.0 5.1 5.0 4.7 4.5 4.7 4.5 4.3 4.1 4.5 4.5 4.4 4.6 4.5 4.3 4.3 4.3 4.1 4.2 4.1 4.1 4.0 4.0 4.1 3.6 3.7 4.0 9.6 10.1 8.0 7.4 7.5 7.1 6.7 6.4 6.3 6.6 6.4 6.2 6.0 5.9 5.9 5.7 5.8 5.3 5.9 5.9 6.0 5.8 5.5 5.4 5.4 5.0 5.3 5.4 5.4 5.1 5.1 5.1 4.6 4.5 5.2 5.3 30 ppm 14ale Female 3.0 2.7 2.3 2.0 2.0 1.8 1.8 1.5 1.5 1.5 1.5 1.5 1.4 1.3 1.4 1.3 1.3 1.2 1.3 1.3 1.3 1.4 1.3 1.3 1.3 1.2 1.1 1.2 1.2 1.2 1.2 1.2 1.2 1.0 1.1 1.1 3.0 3.1 2.5 2.4 2.2 2.1 2.0 2.0 1.9 2.0 2.0 1.8 1.8 1.7 1.7 1.6 1.7 1.5 1.7 1.7 1.7 1.6 1.6 1.6 1.7 1.5 1.5 1.5 1.5 1.4 1.4 1.4 1.3 1.2 1.5 1.5 10 ppm 14ale Female 1.0 0.9 0.8 0.6 0.6 0.6 0.6 0.5 0.5 0.5 0.5 0.5 0.5 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.3 0.4 0.4 0.4 0.4 0.4 0.4 0.3 0.4 0.4 1.0 1.1 0.9 0.9 0.8 0.8 0.7 0.7 0.6 0.7 0.7 0.6 0.6 0.6 0.6 0.6 0.6 0.5 0.6 0.6 0.6 0.6 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.4 0.4 0.4 0.5 41. Study Week 72 74 76 78 so 82 84 86 as 90 92 94 96 98 100 102 104 Table 8 (concluded) Estimated Mean PM-3924 (mg/kg) Consumption Per Day 100 ppm Male Female 30 ppm Male Female 4.1 5.3 4.2 5.1 4.1 4.8 3.8 5.5 4.0 4.8 4.0 4.5 3.5 4.8 4.0 4.8 4.1 5.1 3.9 4.8 3.9 5.0 4.1 5.1 4.2 5.4 4.1 5.2 42 5.2 4.*1 4.9 3.9 4.7 1.2 1.5 1.2 1.4 1.2 1.4 1.1 1.4 1.1 1.4 1.1 1.3 1.0 1.4 1.3 1.4 1.2 1.5 1.2 1.5 1.2 1.5 1.2 1.5 1.2 1.6 1.2 1.7 1.2 1.7 1.2 1.7 1.2 1.6 10 ppm Male Female 0.4 0.5 0.4 0.5 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.5 0.3 0.4 0.4 0.5 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.5 0.4 0.5 0.4 0.5 0.4 0.5 0.4 0.5 0.4 0.4 42. Table 9 TWO YEAR ONALIDIET) TOAICITY-UNCOUENICITY STUUY OF FLUUWUCANDON MORIALITY UATA FM-3924 IN kA INITIAL I- 5- WEEK Of STuuy 9- 13- If- 21- 25- 29- 33- 37- 41- MALES CONTROL 0 ppm HIGH DOSE 100 ppm MID DOSE 30 PP" LOW DOSE 10 PPM FEMALES CONTROL 0 ppm HIGH DOSE loo PPM MID DOSE 30 PPO LOW DOSE 10 PPM so 0 0 0 0 0 0 0 0 1 0 0 so 0 o 1 .0 0 0 0 0 0 0 so 0 0 0 0 0 0 0 0 0 0 0 so 0 0 0 0 0 0 a 0 0 0 0 so 0 0 0 0 0 0 1 0 0 1 0 so 0 0 0 0 0 0 0 0 0 0 0 so 0 0 0 0'. 0 0 0 0 0 0 0 so 0 0 a 11 0 0 0 0 0 0 0 Table 9 (Concluded)- ToO YEAH IMALIDILTO TOAICITY-UNCObtklClll STUUY Of fLUUMOCARbON FA-3424IN NAT$ ROMIALI[I DATA WLER Uf STUDY 1%111&L Sl- 61- 6!b- 6Y- I)- US- 64- V3- 91- Ill- IOS- "ALES CDOOTOUL 0 pp" "Is" OUSE is* PPO HID DOSE 30 PF" LOW DOSI 1 a PW#4 FIOGALIS CONTROL a pp" MIGM loost too PION PID OOSE 38 Plops LOW 1)1)$E so 1 2 1a I so III 1 1 231 4 4 24 1 be II1 1 2 1 1 6 1 2 3 4 9 so 10 4 1 1a 130 1 12 1 6 3 6 a I1 2 2 1 3 s II be a0 1 3 1 a12426 01 14a36 s3 50 Ia1 0 3 3 30 C"I-$QuANE TLST$ tOR UU$t GNUUP UIFFERLNCLS FROM CONTROL 04&Lt S C041SUitARL PHUH. FEMALES C"ISUUAAE POUD, IGO PP" l(i topoq FJOOO toune 0004 so$99 oeoifl 111 OOP04 U04S 0 at)14? 0004 oek2j Table 10 Two Year Oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon FM-3924 in Rats Summary of Clinical Signs Observations Control m F %S Initial number of rats Survivorg at end of study Mase(es)- in various regions (Mase(es) resolved prior to termination) Alopecia in various areas Swollen throats Palo (blanched) eyes and/or appears thin (emaciated) Excessive lacrimation Raised ulcerated lesion on hind foot pad(s) Ataxia Convulsions (clonic) Occasional urinary incontinence and/or hematuria Occasional bloody nares 65 34 19 (11) 65 100.0 25 45.4 38 43.8 (7) (13.9) 6 14 15.4 13 10 15.4 9 9 13.9 8 12 15.4 7 0 5.4 4 2 4.6 3 0 2.3 5 4 6.9 3 1 3.0 100 ppm m F %S 65 31 13 (6) 65 100.0 34 50.0 21 26.2 (3) (6.9) 6 17 17.7 8 3 8.5 8 6 10.8 7 1 6.2 a 1 6.9 8 a 12.3 10 1!1 8.5 7 6 10.0 1 0 0.8 30 ppm m F %i 50 50 100.0 35 23 58.0 12 33 45.0 (7) (3) (10.0) 9 12 21.0 4 3 7.0 13 7 20.0 6 7 13.0 18 2 20.0 a 10 18.0 3 0 3.0 3 3 6.0 2 0 2.0 a @ Incidence in males + incidence in females) /total number of animals in the group x 100 c To be detailed in the pathology report Indication of Sialodacryoadenitis (SDA) viral infection Also had one Incidence of tonic convulsions Observations Occasional bloody feces and/or diarrhea Occasional episode of dyspnea Listing of the head Nodule on ear Circular ulcerated area on skin Swollen (distended) abdomen Swelling in inguinal area Prolapsed uterus Swollen leg and/or foot Paresis of hind legs Swollen ears Table 10 (concluded) Two Year ora]L (Diet) Toxicity - oncogenicity Study of Fluorocarbon FM-3924 In Rate Summary of Less Frequently Observed Clinical Signs Control m F 2 0 1 0 1 0 0 0 4 3 0 2 I 1 - 0 3 0 1 0 0 0 100 ppm m F 1 0 0 0 1 1 1 0 2 0 0 1 0 0 - 0 2 1 1 1 0 0 30 22m m F 2 0 0 0 2 2 0 0 1 0 1 0 0 0 - 2 2 1 0 0 0 1 4@b ?I TABLE II Two Year Oral (Diet)Toxicity Oncogenicity Study Of Fluorocarbon FM-3924 In Rats Summary Of Ophthalmologic Changes Observations Control - 0 pRm 100 ppm Eye m F m F PhthisisBulbi (Atrophy) Right 0 Left 0 Posterior Subcapsular Cataract(s) Right 2 Left 2 Bilateral 1 Corneal (ocular)Opacity Right 0 (Diffused;ulcerated;with Left 0 focal iris staphyloma; Bilateral 0 enlarged;partiallycollapsed; with microphthalmos; with pannas) 1 1 2 1 0 1 0 0 1 10 1 0 0 0 2 1 1 2 0 0 1 0 0 30 Rpm m F 3 3 00 00 00 00 1 0 1 0 00 10 DR m 2 0 0 0 0 2 0 1 NOTE: Blood sampleswere taken via the retro-orbitalvenus plexus from almost all of the above animals with ophthalmologicabnormalities. (N) Group MALES (1)Control (1)Control (1)Control (1)Control (1)Control (1)High Dose (1)High Dose (1)High Dose FEMALES (1) Control (1) Control (1) Control (1) High Dose (1) t4id Dose Table 11 (concluded) Two Year oral (Diet) Toxicity - oncogenicity Study of Fluorocarbon FM-3924 in Rats Summary of Less Frequently Observed Ophthalmologic Changes Eye(s) Description of Abnormality Right Right Bilateral Bilateral Bilateral Left Right Left Chronic uveitis (secondary to blood sampling) Diffused lens opacity - chronic iritis with m Posterior lens opacity Chronic superficial Keratitis Very pale choroidal circulation Diffused hyphema Extensive inflammation (post blood sampling) Chronic superficial Keratitis Right Left Right Left Right Chronic superficial Keratitis Chronic uvattis with secondary exophthalmia Dacryadenitis Chronic uveitis Diffuse lens opacity with iritis 14ALE TABLE 12 TWO YLAP ORAL IDILI) 7UXIC17Y-UNCutiLNIC11Y MEAN LEUKOCYTE STUUY OF VALUES FLUUIIUCARBON Fm-3924 LEUT(UCYTES NLUTHUPHILS LY14Ptt(ICYTES MTINOCYTES ICELLS X 100031 (CELLS X 10**31 (CELLS X 106031 lCkLLS A 100031 lc N MEAN 5.1)fv. MEAN S&OEV. MEAN S-i)EV. MEAN S.DEV. m M004704 3 0 PP@4 100 PP" 30 PPM 10 PP" MONTH 0 PPM 100 PPM 30 PPM 10 PPM MONT14 12 0 PPP4 100 PPM 3U PIOM lo ppm MONTH 10 0 PPM 100 PP14 30 PPM 10 PP" MONTH 24 0 PP" 100 PPM 30 POJM 10 Pe-lo 15 12.73 2.074 I.bs 0.656 10.72 11.003 O.Im 0.196 0 le@ 15.15* 2.66? 2020 1.325 12.42 2.1820 0.29 0.202 0 Is 13.85 2.471 2.17 1.155 11.20 l.'954 0.26 0.212 a Is 13.73 2.430 2001 1.33b 11.51 Zo'239 0*06 0.003 0 19; 10.74- 2.423 1.43 007LJ7 a . fi!!. 2.'416 0.211 0.100 0 le; 11.64 2.270 1.40 1.3!39 9.714 1095FI 0.27 00253 0 IS 13.700 1.941 1.76 1.097 11.400 1:840 0.36 0.239 0 14 12.41 2.FJST 0#72 0.543 ll.!)?* ZZ?07 O-Oba 0.072 0 14 7.94 1.57? 1010 (i.bl? 6.3b 11.25f, 0.40 0.216 0 14 O.AO 1.849 1.6!) 0.963 6.44 1.252 0.36 0.236 0 8.05 1.0395 1.29 O.b4o 6.11 l.,l314 0.25 00218 0 7.96 2. 7io 1 1971 l.bes S. bi? 1.8?2 0.32 0.265 a Is 11.41 7.3?5 s.f)t- 6.402 5.61 1.504 0.59 0.405 0 is 8.464 3.303 k.060 I.Jeh 5.03 l.'814 0.4og 0.420 0 15 8.98 I.Zl? 2*i!!) l.l?t4 6.01 11206 0.60 0.232 0 is lo.13 4.123 3035 3.209 b.14 1 417 0.45 O.Zb7 0 Is 10.79 7.529 3.72 S.666 b.bb 20,140 0.34 0.39A 0 is 8.91 3.919 1645 1.009 7.21 3.'718 0.21 0.159 a is 10.BT 4-411 3*en 2.754 I.On 2'916 0*46 0.386 a is Y.S3 3.84S k*Vh 3.292 bo?u 1 @844 001, 00170 0 : P Its .05. a : P @cs oOS. TWO TAILE(I NUNNLIT TWO JAILED DUNNEIT T ON kaki VAT$. T ON KANKLFJ DATA. MALE MONT" 3 a PP#4 100 PPM 30 PPM 10 PPM MUNT" 6 0 PP04 100 PP$4 30 piji4 10 ppfo 04UNT4 I? 0 PP04 100 PIJ$4 30 P$414 10 PIJM 18 6 PPP4 100 olp" 30 ppm 10 P$064 TABLE 12 IWO YEAW UHAL (DIET) JUXICITY-UNCUbEP41CIly STijUY OF kLU UW(JCARBON FM-3924 IN HATS EMYTHWUCVTLS (CLLLS A 109'bi k 04LAN S.DEV. MEAN htMUbLUdIN (ii/I)LI HEMOGHAM VAI.UES 14tf4ATUCWIT 1* PACKLI) CLLLS) MLAN souty. MEAN S-UEV. 14cv (MIC$40NS*03) "LAN S.DEV. mcm (PICOGNA MEAN S*D 1 Ci 8.29 Is 8.10 Is b.12 is b.Z? 0.3;e2 0.33b 0.26b 0.?65 16.4 16.1 16.2 lb.b 0.39 0.50 U.66 u.bb 4S.3 4S.1 #6.1 O.vb 1.35 1.68 2.17 bb I.Y 19.0 56 2.4 lio.0 a 56 1.6 1909 0 56 2.9 2UO2 a Is 8.42 0.3ti4 Is h.21 0.9?2 is 7.39* 0.*bl 14 b.@9 0.403 lb.1 14.4 is.4 lb.2 0.94 lo" 0.7@o D.bO 44.S # 3. 3 4b.? 4S.b 2.?0 4.S? e.31 1.?4 5;1 4.3 53 2.? bl* 3.8 S4 1.5 1?.V I 17o6 0 20.Vo 1 iti.1 0 14 13.44 0.554 14 0 .2co 0.,-?v Is b.*o 0.36b 15 0.30 0.435 15.4A L4.d* lb.8 IS.? 1.1? 0.4b a.b? O.be 46.7 44.b 4h.? 45.5 4o69 i!.47 2*31 2.13 Sb 2.2 18.8 a b% 2.4 1?.0* 0 56 2.4 toob 0 55 1.9 19.0 0 Is 7.48 is 0.14 Is ?.63 Is ?.74 2.071 oo6is 1.(14t$ O.tl*)b 15.1 lb.V lt.1 15.3 3.1? looh I.bv 1 .!)SO 4n,ti 4?.k* 41.4 41.v V.14 @0.11 b.DS fa bb !)b bus bb b4 6.2 3.1 ?.? 2.3 21.0 1 IV*4 0 19.V 1 IV** @o 0 Piim 100 PP" 30 Pi'm 10 PION Ln I gi 7.h4 is 7o?? If% ?.ON 15 6.3k% l.oh3 1.303 1.25b o.v74 14.5 141.5 1%.h IS.9 1 .!)V i:.Ljl I.bi* 1.?b 42.J 42.7 43.3 46.1 !5.34 b.63 b.lfl 6.10 be 3.4 5b 2.8 16.7 1 bb 3.6 IV.v I Sb 3o9 IVOU 0 P Itc .#Jt.. IPO ]AILED P fu DS. TW(l TAILKD OUIONfli DUN%ETT I (JN HAI. UATA. I Uto NANKLI) DATA. TABLE 12 TWO YEAR ONAL (UIETI TOXICITY-ONCOGENICITY STUDY UF FLUOROCAKHON FM-3924 IN MALE RATS INDIVIDUAL HEMOGRAM VALUES ------------------------------------------------------------MONTH=3 ------------------------------- DOSF ANIMAL ERYTH "EMO HEMAT mcv MCH mchc wac PMNAB 0 PPM 0 PPM 0 PPM 0 PPM 0 ppm 0 ppm 0 PPM 0 PP" 0 PP" 0 PPM 0 ppm 0 PPM 0 PPM 0 PPM 0 PPM 100 PPM 100 PPM 100 PPM 100 PPM ion PPM 110 PPM iftoPPM 100 PPM ion ppm ino ppo ion ppm lao PPM ino PPM ino ppm 110 PPM AIR3518 AIR3527 AIR3532 AlR3S34 AIR3537 AIR3S40 AIR3542 AIR3548 AIR3SS2 AIR3SS9 AIR3562 AIR3S64 AIR3S6S AIR3567 AIR3569 DIR3701 ()IR3703 DIRI?OS DIR3706 DIR3711 f)IR3714 DIR3719 DIR3?23 DIR3?24 nIR3727 nIR3T34 r)IR1740 DIR3748 DIR3?49 DIR3TS4 8*10 70?7 8969 A.IS 7.71 Flo04 A.ro Ael3 8020 A-63 A.73 Ao37 8*41 A.24 e*46 A.44 R*62 8*?0 fl.19 7.91 7.?o R.03 7.40 8*27 70?9 806S 7.97 A.03 A004 Fl.27 16.1 49i is.ti 44 lb*S 4b 16.3 45 16.3 45 16*7 46 16.fi 47 16*S 41 16.6 46 16.4 46 15.6 45 16.ft 4T 16.3 46 16*A 4T 16.6 41 16.0 47 15.4 43 16*5 46 IS.6 45 lb.3 47 IS.3 44 l6o3 46 IS.6 44 16.2 46 IS.4 43 16.4 46 17.1 47 16.2 45 16.1 4S 16.4 46 SS.5556 5666?Hl S2.9344 SSo2l47 SH*36SA 57*2139 54*0230 5768106 S6*0976 53*3024 5165464 56.1529 54&696A 5700309 SSoSS56 5566872 49#8840 S6*0976 54*9451 5944185 iT.1429 57*2852 5944595 5S66227 S"V.1990 S3*1?92 50*9711 S6,0399 55.9701 55%6227 19,8165 1909485 19*9dl3 20.0000 21*1414 20.7111 19.3103 20.?952 20*?439 1990035 17.8694 19.9327 19.3017 20.3dd3 l9o6217 IR19ST3 l7.8b54 20.1220 19*0476 2096068 ig.oroi 209?4"9 21.0011 19,5d"Q 19.7689 10.9s95 21.4b5S 20.1743 20.0249 19,6307 39,7778 35e22Y3 3S*8696 36,2222 36.2222 36*3043 35,7447 3S,1064 36,0070 35.6522 34*6667 3S*3191 3S*4348 35.7447 35.3191 34.0426 3SeRl4O 35.8696 34*6667 34obOO9 34.7727 35*4348 35.4S4S 35.?174 3S,0140 3S.6522 36.3830 36.0000 3S,1?78 3S.bS22 12.60 11.00 10,00 l3o3O 11930 12.50 12*60 iseso 14*00 ll.SO 11090 l2e6O 9058 iseso 11.00 19*60 15*30 13*f)O 16.SO 13*00 15*60 18*50 llo?O 17060 18.20 16.60 lle30 12*00 12*00 14*80 193860 106500 100000 1*3300 2*4860 108750 103960 296350 lo9600 1*0350 2.?610 1.3960 0,7664 297900 O.HSOO 514880 1.3770 196S60 109800 106900 100920 0.9250 1.0530 2.8160 0072RO 2.R220 4o40?O 2*04AO 2,6600 2*0720 e-n TABLE 12 TWO YEAR ORAL 4DIET) TOXICITY-ONCOOENICITY STUDY OF FLUOROCARROt4 FM-3924 IN MALE MATS INDIVIDUAL HEMOGRAM VALUES -----------------------------------------------------------M-O@iti*3 ----------------------------- F)OSE 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PP" 30 PPM 30 PP04 30 PP" 30 PPM 30 PPM 30 PP" 30 PP'4 30 PPM 10 PPM 10 PPM 10 PPM in PPM 10 PPM 10 ppta 10 PPM 10 PPM in PPM le PPM 10 PPM 10 PPM 10 PPM 10 PPM In PPM ANIMAL FIR3767 EIR3770 EIR3771 EIP3TT3 EIR3774 EIR3778 EIR3?80 EIR3783 EIR3787 EIR3790 FIR3791 EIR3796 EIR3ROO EIR3001 EIR3906 FIR3811 FIR381S FIR3Ml8 FIP3822 FIR3924 FlR3A3l FIR3R32 FIR3034 FIR3836 FIR3838 FIR3e39 FIR3940 FIR3$144 FIR3847 FIR3852 ERYTH R.11 8o2S TOGO R*16 8.23 R*52 7.96 Ro4l 7.79 8*12 7.84 7089 8o6S 7091 8e24 13.s9 8017 A.2q R.62 8.63 9.04 R*78 7,92 To27 7oT6 7.63 9.90 7.OR T.4.'i 8.74 HENO lc;.s l6o6 1601 16.2 IT*3 1693 16*1 1699 15*8 16.5 1508 l4e5 16.f; 19.R l6o2 16*4 16*5 l6o6 17.6 16.9 1?04 16.8 16*0 15.1 15.9 16.0 l8o4 1594 16*1 1792 HEMAT 44 46 46 45 47 46 45 47 43 46 44 41 47 44 46 46 46 46 48 47 48 46 46 42 45 40i %1 43 4S 46 mcv 54.2540 SS.?s76 so.9744 S5.1471 57.1081 b3*9906 56*5327 5568859 SS*1990 56.6502 5h.1224 b2o03OS 54.3353 5So6250 55.82b2 S395506 56.3035 SS*4605 54.4218 54*4hlZ S3.0973 )2.391H sooosom 57.7717 57*9097 5809777 51.5152 60.734S 60.5653 S4*9149 mcm 19.1122 20.i212 20*6-410 IYORSI?9 21*0?07 19.1315 20922hl 20*09!111 20.28?4 PO.3202 20.l'i3l 1804 010 19.4?'d!O 1909747 19.6602 1990920 20,1958 20.0?41 19.4S46 191SRe9 IYO?478 1901344 21.2121 20.i?03 20.@897 20.4 699 ie.s'e-)g 21,TS14 21.6689 1996746 MCHC 3%.2273 3hoOB70 3590000 36.0000 36.8085 3S*434R 3S*7778 3599574 36*7442 3SoR696 35*9091 35.3659 35*7447 35.9091 3So2l74 3So6S22 35*8696 3hoOB70 36.6667 35,9574 36o25OO 36o5217 36*5211 3So9S24 3Se3333 3So55S6 36,0784 35*0140 35.77?9 35.8333 woc 16.30 12o?O 9*Tl 12980 11*20 16*60 14*40 16*10 11080 l2o4Q 16.40 l6o8O 12*30 13000 13*30 lie8o 12.00 13*10 16*90 9.80 14*20 14.50 13*SO 14*20 11940 16090 11*10 in*90 l4o40 12*50 PMNAB 3.0970 0,63SO 1,4565 2*0480 2,3520 296040 1*4400 3*8640 2*1240 lell6o 109680 5,0400 2.0910 109500 007980 108880 1.1520 2,4890 5*4080 ils6so 4eS440 2*4650 I*R900 1.4200 0*9120 1*8590 0*9990 108900 I.IS20 005000 TABLE 12 TWO YEAR ORAL (DILT) TOXICITY-ONCOGENICITY STUDY OF FLUORUCARRON FM-3924 IN MALE MATS INDIVIDUAL HEM06RAM VALUES --------m ------------------m--w----------------------------- MONTH,6 ---------------------m--------- NOSE ANIMAL ERYTH HEMO HEMAT mcv MCH MCHC wac PMNAB 0 PPM AIR3519 A*24 IS.o 46 0 PPM AlR3S?4 nesi 14.4 42 0 PPM AIR3S29 R*23 1406 44 0 PPM AIR3533 8,30 IS.7 4S 0 PPM AIR3S3? 8.13 15.9 47 0 PP" AIR3S41 8.42 IS09 46 0 PPM AIR3S4? ?.40 14.8 44 0 PPM AIR3550 8938 IS.4 4S 0 PP" AIR3553 8*30 lSo6 46 0 PPM AIR3SS? A.9s 13.o 37 0 PPM AlP3SS9 9603 16o2 4? 0 PPM AlR3S62 Ross 14.8 4S 0 PPM AIR35bT 8.69 16.2 47 0 PP14 AIP3S?3 8.70 isoo 4S 0 ppm AlP3SIS A*44 l3o5 41 100 PPM DIR3696 7.63 12o7 37 100 PP" nlR37o3 8*13 13.8 42 100 PPM DIP37o? A*31 15.0 44 100 PPM DIR3710 01.70 14.3 43 loo PPM DIR3?16 8.10 15*3 4S 100 PPM nIR3T28 8.93 IS.8 47 100 PP" DIR3731 8o32 ]4o? 43 100 PPM I)JR3133 9.10 15.4 47 100 PPM DIR3?34 Ro3? 14*5 44 100 PPM DIR3?36 go2l 14.0 43 100 PP04 nIP3738 8099 16.1 49 100 PPM DIR3?43 4999 907 30 100 PPM 100 PP" I)IR3746 DlP37S4 8*44 A020 IS.6 46 14*7 44 100 PPM DIR3?S? 8.70 ]4oT 45 55.8252 44o3S3T 53.4be9 54.2lb9 il.olob 54.6310 59.4s9s 53o6993 5594217 41.3408 52*0487 t,2.4476 54.0852 51.7241 4bo5782 48.4920 51*6605 t)2.9403 49.42S3 55.S556 52.6316 51.6827 SI.64R4 S2.5607 h2.3152 54*5050 60el2O2 54.5024 53*6585 51*7241 IA*?039 16.9213 17.7400 IRS91si 19*SS72 IH*Ekfi3b 2DoOOOO IR*3711 10,T9'.312 14.S251 1709402 17*2494 loo6421 1702414 lSe99S3 1696448 lbo9742 1800SO5 16*4368 1808889 17.6932 17*6683 1609231 17.3238 1790524 1709088 19*4389 18*7204 17.9?68 1698966 32o6o8T 34.20ST 3391618 34*8989 33*8298 34.5652 3396364 34*2222 33o9l3O 3S.1351 34,4681 32*8009 34o468l 33o3333 32o9268 34.3243 32oeS7l 34.0909 33.?SSS 34*0000 33,6170 34*1060 32*?660 32o954S 32*5561 32*eSTI 32*3333 34e3478 33.4091 3296667 7*TO 8.98 11970 9e96 9*14 9*83 14900 70TI 10090 13940 8020 10.71) llo30 11930 16*30 ISOTO 11080 iooso 8*30 l4o2O 9041 13.10 l2oSO 10070 11080 10050 14*IBO 8*04 10*30 13ooO 193090 lo2S?2 loOS30 loS936 le64S2 099830 192600 1*6962 3,5970 1.7420 OoST40 IOIT?O 0.3390 105820 lo6300 4,7100 1.0620 100900 lo3280 3*2660 0*3764 0*65SO 1.3750 0*6420 005900 108900 0*2960 094020 0*2060 3oSlOO Ln TABLE 12 TWO YEAR ORAL 401ET) TOXICITY-ONCOOENICITY STUDY OF FLUOROCAROON FM-3924 IN MALL RATS INDIVIDUAL HEMOGRAM VALUES ----------------------------------------v--------------------MONTH26 ------------------------------- DOSE 3o PPM 30 PPM 30 PPM 30 PPM 30 PP" 30 OPM 30 PP" 30 PPP 30 PPM 10 PPM 30 PPM 30 PPM 30 PPM 30 PP" 30 PPM 10 PPM 10 PPIA 10 PPM 10 PPM 10 PPM 10 PPM 10 PP4 10 PP" 10 PPM In PP" 10 PPIA 10 PPM In PptA le PPM 10 PPM ANIMAL EIR3?62 EIR3?63 EIR3?64 EIR376S EIR3TTo EIR3??3 EIR3?74 EIR3?79 EIR3Te4 EIR3T92 FIR3794 EIR3004 EIR3906 EIR3808 FIR31110 FIR3811 FIR3816 FIR381T FIRIR23 FIR3826 FIR3827 FIP3031 FIR3R33 FIR3834 FIR1837 FIR3839 FIR3846 FIR3853 FIR38S4 FIR3855 FRYTH 7.92 7943 7*63 ?o6T ?o3R 6*40 7.11 TOS9 7*73 6.99 7.78 7*13 7.44 6*4#i 0.04 A.65 A*03 8.27 Rail 8*30 9.15 A.TS A.48 R,i%2 9.92 A*46 To6o 8,67 T*40 HEMO 16.6 15*4 IS*4 15.5 15*3 13.7 15.3 17.1 1601 14.8 IS.ft IS.0 15.4 IS*3 14.9 150? 14.5 ises 15.4 15.5 15.6 15.5 15.0 1507 IS.5 15.2 13.9 16.0 14.2 HEMAT 49 45 4? 44 44 40 45 49 44 43 4? 4S 46 46 44 45 45 46 45 46 47 47 46 46 4FI 45 62 47 4? mcv hl.H6o7 6Os5b53 61*5990 5To3bb4 59.6206 6265000 63.2911 6495S06 56ty21l 6145165 60*4113 61*391S 6leR280 T102074 54o?264 52*0231 bb*0399 55*6227 SS.4071 5544217 51*3661 53o?143 S4*2453 53.3b43 tijotoll? 53*191,i SSi?632 5492099 56o7SbP a MCH 20.9S9h 200?2b" 20*1035 20.2086 20,7317 21,4062 21.5lqO 22*5296 20,8279 21*1?31 20*308S 20,463R 20,6989 23,6h4Z 18.5323 17.5723 l8o8h73 18.7424 16,9"my 18.674? IT.0492 17.7143 17.6her 18.2135 i7.3rhi 17.9b64 la*2695 19.4544 1901892 MCHC 33.8776 34*2222 3?*7660 35,2273 34,772T 34,2500 34oOOO9 34,e9Rl 36.5909 34.41RG 33.bITG 33e3333 33*4783 33,2bO9 33,8b36 33.7778 32,2222 33,69S? 34,2222 33.6957 33.1919 32.9787 32,6097 34,1304 32.2917 33*7778 33,09b2 34*0426 33,8095 WRC 14.20 12.90 14.20 14.70 13*20 11.90 11.10 13.40 8095 17.00 isoio l5oOO 14*00 IS*20 14.60 12050 15.30 l2o8O 139RO Bois 14*60 l8o4(i 11*20 11090 11.10 14*80 8e4S lieso 9000 PMNAB OeRS20 1*2900 lo4200 1.9110 109800 2*0230 1.66so ?91440 1*3425 4*5900 193S90 006000 0,4200 3*6480 101680 00?SOO Oo3O6O 005120 106560 8el630 0*4380 1.1040 093360 0.9S20 108070 097400 001690 Oo9440 001800 r-n TABLE 12 TWO YEAR OHAL (DIET) TOXICITY-ONCOGENIOITY STUDY OF FLUOROCARRON FM-3924 IN MALE PAYS INDIVIDUAL HEMOGRAM VALUES ----------------------------------------------------------M-ON-THNIZ ------------------------------ DOSE ANIMAL ERYTH MEMO HEMAT mcv MCH MCHC wac PMNAB 0 PPM n PPM 0 PPM 0 PPM 0 PPM 0 pp" 0 PPM 0 PP" 0 pp?4 0 PP" 0 PP04 0 PP04 0 PP" 0 PP" 0 ppm 100 PP" 100 PP" 100 PPM 100 PPM too PP" 100 PPP 100 PP" too PPM 100 PPM 100 PPM 100 PPM too PPM too PPM 100 PPM too PPM AIR3516 AIR3517 AIR3520 AIR3522 AIR3S27 AIR3535 AlR3S43 AIR3S46 AIR35SO AIR35SI AlR3SS4 AIR3S68 AIR3STO AIR3S?S AIR3580 DIR3696 DIR3699 0193?11 DIR3?14 DIR3715 DIR3?20 DIR3721 DIR3722 DIR372T DIR3732 DIR3?33 DIR3736 nIR3?3? DIR3?47 DIR3?48 R*33 8.0? 8.49 8*47 8,84 8.47 IR*97 9.47 9*12 8,4FI 7,Aig 8029 7.27 8004 8*32 7.21 8941 7.75 8.28 8.54 8.81 M.40 A.37 Ro33 8090 13.48 7,89 8e3l lSo6 46 15.7 45 IS*7 45 16.4 4T IS.7 46 15.6 45 16*4 48 iaoi 55 16*4 51 IS.8 4? 15:8 4; 1604 47 12.5 38 15*9 46 13*6 43 14.3 40 1501 so 14o3 41 isoi 44 IS.2 45 15*3 47 14*6 4S lc;ol 46 IS.0 44 14.8 46 l4o2 44 15:2 4; 14*6 44 57*6230 55*76ZI 53*0035 55*4909 52*0362 53*1281 S3*5117 5800?01 SS*9211 SS*424S 56:3756 S6o6940 S2o269b 57*2139 51*6027 b5.4785 59.*530 b2e9o32 53.1401 sz.6932 53-3405 53*S?14 54.9SH2 S2o82ll Slo68S4 Sld8b66 58:3016 52*9483 10*7275 1994548 18,4923 19*362S 1?-7602 18.4179 18*2832 19*1130 1?-9825 18*6321 20.60SO8 19.?929 l?ol939 19*7761 16*586S 19*8336 1?.9548 1994516 10*?367 IT*7986 17*3666 17*3810 lRoO4O6 18*0072 1696292 16o?453 19:2649 l7eS692 32*5000 34o88H9 34.888Y 34*8936 34ol3O4 34*6667 3491667 32*9091 32*IS69 33o6l7C 34:3478 34*0936 32.8947 34*5652 32*0930 3S*?900 3092800 34o8T8O 3403102 33*7?76 32.5%32 32*4444 32e8261 3400909 32ol?39 32@2727 33:043S 33*1818 ?,9 502 698 902 ?*4 901 6o9 802 517 902 R:o ?*0 909 100? 9*5 907 902 ass llo6 6*5 11.6 609 Too Roo Be? 4*4 9:1 9,7 lesit 00624 0*816 09736 0.814 2*002 0.928 0.328 09399 loS64 1:520 lo260 0049S 20140 2*4?0 2*231 19932 2,210 3*712 10300 3o248 2,136 0.702 0*640 2*001 Oo6bO 1:911 006?9 4Ln @n TABLE 12 TWO YLAN OHAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCAH"ON FM-3924 IN MALE MATS INDIVIDUAL HEMOURAM VALUES ----------------------------------------------------------M-O-NT-H=12 ------------------------------ DOSE 10 PP$4 30 PPM 30 PPM 30 PPM 30 PPM 10 PPM 30 PPM 30 PP#4 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PP" 10 OPM 10 PP" 10 PPM 10 PPM 10 PP'4 10 PPM 10 PPM In PPM 10 PPM 10 PPM to PPM 10 PPM 10 PPM 10 PP" 10 PPM 10 PPM ANIMAL EIR3769 EIR3775 EIR37T6 EIR37?9 EI"3780 EIR3782 FIR3?91 EIR3?92 EIR3797 EI"3800 FIR3902 EIR3eo3 EIR380S EIR3806 EIP3808 FIR3812 FIR3813 FIR3814 FIR3015 FIR3819 F193820 FIR3A20 FIR3832 FIR3433 FIR3835 FlR3R39 FIR3044 FIR3A46 FIR3849 F103860 ERYTH Best 8.68 8*79 S*SO 894? 8060 8.70 8.41 8.90 8.15 7.72 7.94 8.6? 7.86 8.01 8.33 8.21 eooq 7.79 T.qq 8.39 8.21 8.438 8*60 8.13 8946 7*49 800(l 6066 9*23 HEMO 1507 15.9 16.4 1700 16.1 IS*5 15*3 16*0 16.2 16.2 14*2 15.7 iseli 15.5 14.9 Ii.? 16.3 15*6 IS.0 IS*4 isos 15.2 16.? 16.2 iseo 15.R 15.0 15*3 16*6 16*5 HEMAT 49 47 so so 46 46 45 47 49 46 4? 4k9 4? 46 43 46 4R 45 43 45 44 44 5A 4S 44 47 42 4r, 48 47 mcv 57.5793 54.1475 56.0820 SO.8235 54*3093 53.4084 5167241 SS.8859 55*OS62 56.4417 54.4041 60.4534 54.2o99 58.5242 53.54q2 55*2221 58*4653 55*6242 55.149o 56*3?04 S2.4434 53,5932 Sh.3063 52.3256 54.120S 5S.555b 5b.074" 56*2500 SS.4273 5009209 MCH 18.4489 IA.3100 IM.6576 20*0000 19.00"3 IA90233 IT.S862 19.02SO IR.2022 19.8773 18.3938 19.7733 1892238 19.7201 1894309 lp,"475 14.b538 19*2831 19.?555 19.ZI41 18.4744 IA.%140 18*0063 IR90372 lAo4SO2 18.6761 20*0267 19,12so l4ol686 I?e"165 MCHC 32oO4@8 33o829R 32-8000 3400000 3sooolo 33,69ST 34*0000 34*0426 3390612 35*21?4 33-BOVS 3297083 33.6170 33069ST 34*4186 34.1304 33*9583 34*6667 34*8"37 34.2222 3592273 34.b4SS 33o4O9O 3690000 34.0909 33obl?O 3S.7143 34.0000 34.5833 35*1064 wsc 0.3 10.3 9o2 700 1006 7.9 6o2 Soo 4*4 6.2 9.2 7.9 T*4 900 1(1*2 l3o9 1101 6o4 So3 11.3 SOS 6.0 7.n 6*6 6.9 8.7 11.3 7.1 4#0 S*3 PMNAS 1.494 2.163 2*208 14.960 29862 0.790 0,248 1.920 0.660 0.620 loT22 1*422 0*444 00900 0.000 6.9so 2*109 0.128 pol9s 1.017 1095s, 09420 1.750 o*s28 19311 2.262 1*921 2oT69 10160 0*530 Ln TABLE 12 TWO YEAR ORAL 4DIET) TOXICITY-ONCOOEMICITY STUDY OF FLUOROCARRON FM-3924 IN MALE RATS INUIVIDUAL HEMOGRAM VALTIES ------- ----------------------------------------------------MONTHmig -------------------------m--0-- DOSE 0 POM 0 PP14 0 PPM 0 PP44 0 PPM 0 PPM 0 PPM 0 PPM 0 PP" 0 PPM 0 PPM o PPM o ppm 0 PPM 0 PPM too PPM 100 PPM 100 pom lno PPM 100 ppm too PPM 100 PPM too PPM 100 PPM 100 PPM ino PPM too PPM 100 PPM too PP" too OPM ANIMAL AIR3SIQ A193521 AIR3526 AlR3S31 JkIR3536 AIR3S39 AIR3542 AIR3SS2 AlR3SS3 AIR3SSS AIR3561 AIR3565 AIR3S6? AIR3574 AIR3571 DIR369T nIR3700 DIR3?07 DIR3113 DIA3717 DIR3?23 DIR3724 DlA3T30 DIR3?31 DIA3738 I)IN3740 DIR3?46 r)IR3?Sl r)lml?ss DlN3?S6 ERYTH Ro42 2s48 8092 8943 8,23 8*14 9o79 8.17 8932 T*99 9oO6 4*75 80?5 3*59 8o64 ?.29 9*47 7.80 9*21 7o72 T*42 7.28 8o96 7*82 Soso 1099 B.S4 So7l 8.56 8*61 MEMO 15*3 7*2 16*S l6o9 IS.9 16.4 1608 16.6 16.9 IS.8 17o6 12.3 l6o4 609 16*7 1401 16.2 16*4 17.4 IS*4 1500 14.0 15.9 IS.2 17.0 lboh 17*2 16.H 14,9 16*3 HEMAT 44 IR 44 46 45 43 47 44 4s 43 4A 31 46 23 4S 39 '#? 49 51 47 44 41 48 44; 49 50 52 51 46 49 mcv 52.2565 72.580b 4993274 54.5670 S4*6700 52*8256 53.4699 53ogbSb 54*006S S3odl?3 52.9801 6S.2632 55.7576 64oO6b9 52.0033 53.4979 SS.4900 62*8205 55.3?46 60.8800 S9o2992 56.3187 53.5714 57.S448 S?*6471 62.5782 60.9899 SB.5534 53.73Fk3 S6*9106 PACH l8ol7lO 29,0323 IR*4978 20.0474 l9o3l96 20*1474 19,1126 2DoS630 2n.3125 19,7747 19*4260 25.0947 lq."Ioa 24.7911 l9o32R7 19*3416 19.1263 21.02S6 l8od925 19.4492 2Oo2lS6 19.2306 17e?45S lQo4373 2000000 70.7?60 2061405 IQ*2802 17.4065 18*9315 MCHC 34.772? 40*0060 37,5000 36.7391 3S*3393 3Rol39S 35o7447 3891818 37*S596 36*7442 3696667 3996774 3Seb522 38*69SI 3791111 360IS38 34o4b8l 33odb694 34.1176 32-1660 34.0909 3491463 33*t?90 33o?778 34.6939 33e2O9O 3390?69 32*9412 32.3913 33e2693 voc 10.0 3S.4 8.7 9.1 6ol ?93 798 909 6o7 8*7 9*7 10*5 12ol 19o4 907 796 8*4 S09 900 501 sel 17*9 Sol 9.2 803 700 SOO 801 13*2 Be? PMNAS 49400 26,196 4.1?6 1.?29 1,769 3,139 2.418 29ST4 20211 lo2l8 3*977 4*725 3o8T2 129028 11455 Oo936 1,092 Oo76? 19980 loIT3 le425 5.370 lo?82 2,024 2*90S 3*ORO 00700 10701 4o224 10740 Ln TABLE 12 TWO YEAR ORAL (DIET) TOXICITY-ONCOOENICITY STUDY OF FLUOROCARBON FM-3924 IN MALE WAYS INDIVIDUAL HEMOGRAM VALUES --------- -------------------------------------------------M-ON-TH=lg ---------------------------- DOSF 30 PPM 3o PPm 30 PP$4 30 PPM 30 PP" 30 OPM 30 PP4 30 PPM 30 PPM 30 PP#4 30 PPM 30 PPM 30 PP" 30 PPM 30 PPM 10 PPM 10 PPM 10 PP$4 10 PPM 10 PPM 10 PPM to PPM 10 PPM 10 PPM to PPM 10 PPf4 10 PPM 10 PP$4 10 PPM 10 PPM ANIMAL FIR3762 ElR3T64 EIR3?6S FIR3767 EIR3769 E193171 EIR3?73 EIR3775 EIR3??? FI"3782 FIR3?87 EIR3193 EIR3?96 EIRIS06 EIR3eO7 FIR3811 FIR3813 FIR3814 FI"3823 FIR3R2S FIR3837 FIR3839 FIR3842 FIR384S FIR384A FIR3851 FIR3852 FlR38S3 FIR38SS FIR38S9 ERYTH 7.69 8oS4 To44 8o39 8*06 1*84 T*12 8-27 Bois 4.10 TOTS) 7.81 7*44 ?.qs 7.95 8.14 8*09 TOST T.?4 8.69 8.3Q 8ol3 7.65 S.OFI n.jr, To9r) 893" 7.60 ?.54 6.89 HFMO 15.4 l6o2 16.2 15.6 15.6 1502 14*0 16*1 15*3 9.4 14.9 15.R IS.CI 16.3 1409 14.9 15.9 15.7 IS.1 1606 16.2 ifi.0 16.1 10.S 17.2 1593 16.0 IS.3 14.9 13.3 HEMAT 4c; 46 44 44 45 43 39 45 42 25 41 43 42 44 41 41 44 47 41 46 44 43 44 28 4A 4? 44 42 1*3 36 mcv Sh.5438 S3.bb42 59*139H 4434 5s2s:83l3 54 M469 54:77%3 54.4135 SI.S331 9T96 6502:69q2 55,0576 56.4516 SS.34S9 51.5723 50-36Ah S4.3titil 55*4h?2 52097]h 52-9344 52.4434 52."905 SI.5163 55.1101 so.fiqsl 52.8302 5295060 54.68?S 57.0292 52.24q6 MCH 20.0521 IR.'4696 21*7742 JR.5936 19.3548 19*3079 19.6629 19.4680 lao?730 ??o9268 10*1517 20*2305 20*"333 poeso3i in.6ib4 1".3047 19..5303 20*.1390 ig.sogo 190,1024 1903087 14*61102 21*04%8 ?O@6693 21*1043 1992453 19.0931 19.14219 19*7613 lq.3033 mcmc 34.2222 3S.2174 36-8182 35,45*5 34.666T 3So3468 3-i.11914 3S*7770 36*4286 3?obOOO 36o3415 3697442 36*9048 37oO4SS 36*09?6 36:3g4a1gS is I 3793810 36.8e93 36*0(4?0 36*8182 3?92043 36*S909 37*sooo 35*0333 36.4286 3693636 36*4286 34.6512 36o9444 wac 10.2 9.2 yes 10*S Sol 7.2 9.1 9.8 10.4 10.0 7.3 8.1 10.S 8.9 7.6 10.2 20.S 9.1 10.8 8.9 505 list SOS S*4 6*2 6 98:1 9*4 9 1147:8 PMNAH 1*224 19564 2.496 2,41S 00891 19366 2.()02 2o352 70808 5*000 2.044 lo620 4o4lO 1,602 1.900 1*636 llo275 2*002 29100 1*936 lo2lO 2,220 2*295 002?0 1,302 1,?26 1.762 49SI2 4*469 100600 (.n 00 TABLE 12 TWO YEAR ORAL (DILT) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARRON FM-3924 IN MALE MATS INDIVIDUAL HEMOGRAM VALUES ----------------------------------------------------------M-O-NT-"224 ---------------------------0-- DOSE ANIMAL ERYTH HFMO HEMAT mcv MCH MCHC WRC PMNAB 0 PPM AIR3SIS 7*44 13.1 37 0 PPM AlR3S24 8008 14*4 43 0 PPM AIN3528 8070 IS.5 4c; 0 PPM AIR3S31 8*33 16.0 47 0 PPM A143534 7*96 IS*3 46 0 PP" AlR3S36 8o54 isoi 45 0 PPM AlR3S42 8o86 16*0 46 0 PPM AlP3S48 6009 IS.6 46 0 OPM AIR3SS4 6*OA 11.8 34 0 ppm AIR3SS? 9o47 16.7 so 0 PPM AIR3S6? T.74 1392 37 0 PPM AIR3564 ?.68 l4o4 42 0 ppm AIR3569 S*38 12.0 33 0 PPM AIR3S?3 8.s2 16.1 47 0 PPM AlM3STS 6*70 12*7 37 100 PPM DIR3700 B.?7 15.6 47 100 PPM DIR3702 7*44 13*9 43 100 PPM DIR3706 9005 16.8 49 too PP4 DIR3709 8*34 1408 42 too ppm 01"3?13 6076 1691 49 100 PPM OIR3?IR 8*57 15*6 46 100 PP" DIA3725 7920 13.9 40 too POM DIR3730 8el2 l4o4 42 100 POM DIR3739 7099 1696 4A 100 OPf4 DIR3?41 6.80 12.7 40 too PPM DIA3746 8040 16.A 47 100 PPM DI"3752 FI*RL 15.6 47 100 PPM DIR37SS 6049 11.6 34 100 POM DIP3?58 7091 1401 4.1 100 PPM DIR3?60 3o96 8.6 23 49.7312 53.2178 51*7241 Sb.4226 57.7beq 52.6932 91.9187 S6.0603 SS.9211 52979A3 47.9036 54.6"75 61.33A3 SS.1643 S5o2239 53.591" 57.79ST 54*1436 5093597 SS-9361 53.67Sh 55.5556 514?241 60.0?Sl Sg*8235 55.9574 53o34AS S2*3883 54*3616 S8.0008 17.bO?S l7ob2l8 1?06161 19.?077 19.2211 17*6015 IA*f)587 1942831 19*4079 1766346 1760543 19.1500 P26J048 18*8967 1869552 1?07679 1806828 JR6563S 17474so 19#3?90 IA*2030 lqojoS6 17,61340 20#7760 100676S 2004)000 17.?072 17&8737 l7ob2SS 2167172 35.4094 33.4884 34*4444 3490426 33-2669 33*SSSb 34o?026 33o9l3O 34*7094 33*4000 3S*6?S? 34.2057 36.3636 34o2SS3 34*3243 33-1915 3293296 34o28s7 35.2381 329$S?l 33.9130 34.7500 34.2091 34.5033 31*TSOO 35.7447 33ol9l5 34.1176 32o79D7 37e3913 13.2 6eg ?.2 F)04 36.3 7*2 Tel 805 4*4 8*0 l2o6 1294 g.? 7.4 12*7 les 1007 6oO 11*4 sea 6.2 607 12*4 490 lsti 4*6 SOS lies 7.9 sea 3.036 1.632 0,432 1*092 22,SO6 1.584 O.TIO lo44S 0.264 1*840 S*922 49?12 09776 leSS4 802ss f)*4so 2.5601 292ieO 1*026 00440 0924R 0*604 Oo?44 2.400 20869 0,230 2*262 2ol36 Oo632 2.?28 TABLE 12 TwO YLAR OWAL (OIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FM-3924 IN MALE RATS INDIVIDUAL HEMOGRAM VALUES ----------------------------------------o------------------MONTH=24 ------------------------------- nosie 30 PP" 30 PPM 30 PPM 30 PPM 30 PPOO 30 PP" 30 PPM 30 PPOO 30 PP" in PPOO 30 PPM 30 PPM 30 PPM 30 PPM 30 PP" in PPM 10 POIA ift PPIA 10 PPM 10 PPM 10 PPM i(ippm 10 PPM 10 PPM 10 ppm !0 PPIA 10 PPM 10 PPO in PPIA 10 PPM ANIMAL FIR37ftl FIR3763 EIR3767 EIR3769 EIR3773 EIR3776 EIR3779 FIR3781 EIR3786 EIR3788 EIR3791 EIR3794 EIR3799 FIR3RO3 EIR3807 FIR3811 FIR381S FIR3817 FIR3822 FIR3826 FIRIO29 FIR3932 FIR3837 FIR3641 FIR184S FIP3648 FIR38SI FIR3853 FIR3856 FIR3858 FRYTH C;046 oel9 8eo2 8056 ?.Sl Sol4 ?082 7o67 8ol3 ROSS 8051 9*16 9*14 6.52 8.63 9-26 I(IOHO 6.53 8.46 e.64 ?.4R 8-sl 13.92 T*RS 7.65 ?0?3 a.s6 9*03 7*87 BIOS MEMO 11*2 15.; 15.9 16ol 13o9 lo.in isoa 14o2 16.4 IS09 Is.9 16*0 l6o3 13.3 IS05 lb.% 20-6 13.3 16.6 16*5 13.9 16.8 17.0 14.0 14.3 15.9 15.7 16.0 IS*3 15.7 HEMAT 33 46 48 48 41 32 46 42 41 49i 46 46 47 38 4s 50 fil 30 49 49 39 49 47 38 40 46 4h 47 44 52 mcv hO.4396 56*1661 5464218 56*0748 S4644"9 fi2ti2bba sFle8235 54*7580 5768106 5n.6757 5490541 SO*2183 SI.4223 S8o282? 5201437 53*9957 !)he4815 5ooIV30 S7*9196 56-7130 52el390 S7oS7Y3 52*6906 48o4O76 5?02876 59eSOH4 S397303 52%04hl 5509085 h4o3S64 MCH 20.cil28 18.9255 18.0272 JR.8084 18,4S95 20o4226 206?046 18.5137 2a.1722 17.OOS4 JR,6"39 17.4672 1?.0337 20*3988 11.4h06 17*8186 19',0741 20,367S 191.621? 19,0972 IR*5829 19*@7415 19,0583 11,0344 1#4*692A 20,5692 IR.3411 1?.Ilol 19,41409 19,4.307 MCHC 33.939* 33,69ST 33,1250 33.5417 33,9024 33ol2SO 34,3476 33o8O99 34,8936 3S.3333 34oS652 34,7026 34*6809 35,0000 34,4444 33,0000 33.?70S 3S.0000 33.8776 33.6?35 35,6411 34.?85? 36*1?02 36,0421 3r),Isoo 34,56i2 34.1304 34oo426 34.7?27 30.1923 woc 17.1 900 9.3 7oo 1009 1602 Ilo3 IS.7 6oS 9.1 8.2 19.7 11.6 5.3 6*2 802 16.6 9.6 901 5*7 692 7.3 ?*S 17.6 10*1 600 8e3 IS*3 7*0 SOS PMNAB 8.208 3o6OO 21697 1.260 lo526 8.262 3o729 gol&4 Oo6SO 3.ISS 1,066 3*152 1.624 0,47? I.SSO 19394 11*620 1.624 1.638 0.912 1*6?4 1.09S 10700 6*688 19212 2*220 0,913 81721 20240 10105 FEMALF ------ MUNT" 3 0 PPM 100 PPM 3o Pets 10 PP" MUNTH b 0 PPM 100 epta 30 PI-M 1ii pep& MUNTH 12 0 PP14 1 U0 PO&O 311 Ptt4 10 pem 04vhlr4 Is ii ppoi 100 opm 30 P&OM 10 pfam MUNI" ?4 0 ppm 1 U0 P064 30 PP,04 1fi pfp4 TABLE 13 IWO YEAN ONAL IDIET) ENYTHHUCYILS ICELLS X 10*06) IUALCITY-UNCU6LNICIIY SIUUY OF MEAN IIEMOGRAM VALUES ML04UULUbIN (tv/UL) HEMATUCMIT 4% PACKLI) CLLLS) FLUUWUCAKOON FM-3q24 mcv 114ILMUNS**3) IN k 04C (PICO N 04EAN S.DLV. MEAN S.L)Lv. MEAN S.UEVE MEAN S.DEV. 14EAN is b.Vi 0.31Y 15 6.nl 0.334 14 7.70* U.Sib IS 7*bS* 0.631 15.ts 15 IQ 15:7 lb.9 0.4b 0.6? 0.4b u.bb 43.1 41.b* 42*y 4 3. @S 1.11 1.72 le46 1.39 b@l 2.2 61 2*S bb* 3.6 bb* 4*3 22fpv 2262 20040 20039 Is ?.:12 0.413 15 6*BS* 0.252 IS 8.02- 0.664 15 7.73 0.551 lb.0 14.0t 15.0 15.1 0.55 0.53 0.48 0.64 42.:$ 41.0 4?.2 42.6 1.84 1.41 1*42 1.88 so 2.2 60 2.5 591* 3.S 55 4.2 20.5 2005 18070 1906 15 7.60 0.300 Is 7.17* 0.444 14 7.bl 0.44&k is 7.38 0.322 lb.6 lio.2* 1!).1 lbo3 0040 a.?? 0*69 u.b7 44*3 42*b 44.2 43.2 1.39 2.29 2.36 1.746 bb 261 5v 1.5 bv 1.6 sio 1.7 2006 lv.s* 20.1 2000 Is 7.37 Is 6,SSO Is 7.29 15 7.b4 Oebbb 1*055 o.b2k 0642V 15.4 13.Yo 14.7 1!).S 1943 lob4 1.1f, 0.03 42*V 40.2 43.7 46.1 4.13 !)o 72 3.33 iet03 5d 1*? 64d* 207 60 2.4 60* 211 2100 21*3 2092* 20%3 is 7.06 1.129 is 6.10 1,227 is 6.-Ol 1 . 7Si: 1 6.4ts 0.73b 14.6 12.3* I:J.4 14.7 l.bo 1 SO4 3.04 1.37 42#4 37.2 39ob 42.0 b.40 6o56 io. 17 3942 60 3.S 2102 61 3.0 20.3 64 8*2 2200 61 2*4 2102 cx .0@,o 7oO TAILFLO Oul-otifiT I UN RAW UATA. P 4m .059 TWO IAILLI) OUNNf7T I UN MANKLU DATA. FEMALE TABLE 13 TWO YEAK UKAL IDILT) TUXICITY-UNCUtiENICITY MEAN LEUKOCYTE STUDY Of FLUOROCARSON VALUES FM-3924 LEUKUCYTES NtUTkOPHILS LymPmOCYTEs MONOCYTES (CELLS X 141*03) (CLLLS X 100031 (CELLS X tOO-31 lCtLLS X 10003) tc N MFAN SoUt V. MEAN SeDLv. 14F AN S-OEV. MEAN S.DEV. m MONTH 3 --- 0--P;14 100 PPM 30 POJM 10 POM MONTH 6 0-;;; 100 PPM 30 PPM 10 PPM MONTH 12 o-;;; ion PPM 30 PP" 10 PP" MONTH 14 loo Ppm 30 Poom 10 PPM MONTH 24 100 PP" Ch 30 PP" 10 PIA" 1-1 iti.9fj 2.6(08 is 16.74 4.405 14 1?.93* 3.bu4 is 15.56 40815 2057 2612 10?7 2*23 1.406 1.3!)7 1.094 0*942 15.73 1402b 10.060 12670 21.970 3.'683 3.393 4*'Tb? 0.37 0.11m 00160 0.36 0021? 00120 0*097 0,273 IS 7.52 2.sb9 I-V 8.34 I.t420 is 8.6? 2.bl5 )5 6.04 lo4Y2 1.44 1*43 1-16 1.33 1.5bb'' 0.572 0.632 O.Sbo 5.07 6641 7.1-# b.?b 21.160 lltson 20,397 1;258 0.11 0*32* 0926 0936* 00096 0*177 0.152 0*173 15 5.73 7.1@o is 5.73 1.532 14 5.49 1.072 is 5.43 1.176 1.27 0ob4 I.IS 0.89 I.S62 U.Sq? 0.576 0*310 4.13 1*1049 0*21 0.108 1 4.43 1*419 Oo3jl 0.163 0 4.0(1 oz9bs 0*26 00138 4*2!) i;iio 0.22 6.12b I 15 S.TS 2.230 1.01 10631 4*48 Oo'f#73 0623 00249 is 5.0)4 1.9U4 I*bSx 1.0@Sh 3973 0;932 0*40 0.190 is 6.23 2.5fis 2.340 2.271 3.400 0;742 0920 0.134 is 6.161 1.836 I%bB* 0.774 3.90 19'160 0.430 09267 4 is 6.73 4.064 2.a7 2.9b9 3.bl 1.329 Ooll ooisi 0 I Ki 7.2s ?.Vr47 2.bb 2.b!)b 4.41 1'*647 00 lip Ool48 0 Is 10.17 6.6f$l 5.87 5.651 3*8tt 1.76? 09360 0.485 0 is 6.?f4 3.31to 2000 1.004 4 o5!) lo'935 0017 00171 0 : P cm .09@9 TWO TAILEO DUNNETT 7 Oti RAW I)ATA. : P cz *05o TWO 7AILEr) I)UNNETT T ON KANKLI) (IAIA. TABLE 13 TWO YEAR ORAL (DIET) TOXICITY-ONCOOENICITY STUDY OF FLUOROCAROON FM-3924 IN FEMALE RATS INDIVIDUAL ME140GRAM VALUES -------------------------------------------------------*----M-ONTH=3 ----------------------------- DOSE 0 PPM 0 Ppm 0 PPM 0 PPM 0 PPM 0 pp" 0 ppm 0 ppm 0 PP$4 0 PPM 0 PPM 0 ppiq 0 PPM o PPM 0 PPM too PPM 100 ppm 100 PPM 100 PP" 100 PP4 too PP" 100 PP04 too PP" 100 PPM too PPM too PPM 100 PP" too PP" too PPM 100 P014 ANIMAL NIR4576 NIR4S78 NIP4582 N144583 NIR45e4 NIR4S92 NIR4610 NIA4612 NIP4613 NIR4619 NIR4621 NIR4626 NIR4627 NIR4633 NIR4640 GIR4?S? GIR4764 GIR4766 OIR4772 0104783 OIR4785 0104790 GIR4?91 GIR4792 OIR4793 OIR4808 GIR4812 GIA4814 OIR4016 OIR4819 ERYTH 6.98 1072 6oT9 6*74 6.31 ?.o3 6*94 6*AR 6.73 7.35 6*60 6.98 6.84 6.84 6o99 6,99 7.05 6o?4 606R 6.64 6.44 7.40 6*91 6.51 7922 6*6S 6.67 6*14 6.BS 7*23 MEMO 15.6 1601 IS*7 IS*6 14,9 16.2 15*6 1507 IS.0 16.S isos 1600 1604 16.0 1694 lSo3 is.1 13*9 IS*b 14.4 14.9 is*$ 15*7 1505 IS.4 15.1 iliou 14*0 14.6 ises HEMAT 43 44 43 43 42 45 44 44 42 4S 42 44 45 44 45 40 42 40 43 40 40 44 44 42 42 41 43 39 4n 44 mcv 61.6046 S6*9946 63.3284 63o7982 6beS610 6400114 63.4006 63.953S 62*4071 6lo2245 63*6364 63oO3?2 65*7895 64.32TS 64*3777 57.2246 59.S745 S9*3472 64.3713 69e2410 62.1118 5904595 63*67SB 64.SI61 SB*I?IT 6lo6541 64*4676 63.5179 58.3942 60.SSTS MCH 22o3496 20odS49 23*,1222 23ol4s4 2396133 2300441 22.4784 22.8196 27*2883 22*4490 23*4848 22*922b 23.4766 23,3910 23.4621 21.8884 2104184 20oh231 23o2O36 2lo686T 23.1366 ?lo3SI4 22*7207 23*809S 21.3296 27*7068 23.6882 22.8013 21*3139 2194385 MCHC 36sa74l 36*5919 36.SI16 36.2791 3594762 36*0080 3So4S4S 35*6818 3S*7143 36*b661 36*9048 36o3b36 36*4444 3693636 36o4444 38e2SO 3S*9524 34olSOO 369046S 36*0000 37o25OO 3S*9091 35obSI8 3699048 36o6661 36o8293 36*7442 3S*69?4 36-5000 3So2273 woc 17.5 20*1 1700 19.4 2005 17,3 IS*4 21*0 16ol 21*0 24.3 2161 19*6 20.4 l4oO IS.1 ises 22.S 26o? 1?09 1297 12*4 1193 14*2 2ooT 14ol 2090 1900 19,3 14*7 PMNAB 1*92S 30417 20040 2ol34 407is 5.982 20156 2.310 29898 09630 1*944 49009 1.176 2eD4O lo260 00151 2oOlS 3992S 2*403 3o3S4 10016 09868 1*356 1*278 4o960 0.423 3*000 29850 2oR9S 194?0 cri 1;4 TABLE 13 DOSE 30 PPN 30 PP" 30 PP" 30 PP#4 30 PP" 30 PP" 30 PPM 30 ppm 30 PP" 30 ppm 31) PPM 30 PPM 30 PPM 30 PPM 30 PP" 10 PPM 10 PPM in PPM 10 PP" 10 PPM 10 PPM 10 PPM 10 PPM 10 PP" 10 PPM 10 PPM In PP" 10 PPM to PP" 10 PPM ANIMAL RIR4822 RIR4A23 RIP4630 RIR4833 RIR4q36 RIR4837 RIR4042 RIR4848 PIR4850 RIR4853 RIR4454 RIR48S6 PIR4R6O RIA4864 RIA4965 SIR4871 SIR48TS SIP4879 SIR4880 SlR4ROI SIP4904 SIR4965 SIR4886 SIP4889 SIR4896 SIR4697 SIP4901 SIR4902 SIR490S SIR4915 EPYTH 7*20 7*31 8.42 7*83 T*33 ?.3S R*12 T.S3 7091 7.53 8099 7*35 7.23 Tefici 7*24 ?ORT 7*60 TIS2 A*29 7*60 7.?l 9*9fi 7065 7087 7.49 Team 7187 7.60 ToS3 HEMO IS.3 IS.0 16*6 1509 16*0 1594 16.3 IS*? IS*3 16*0 1500 15:4 IS*6 16*0 IS*l 16*2 IS.4 15.3 1600 15.7 15.0 19;62 IS*8 16.6 16*S 16*4 1?*S IS*6 IS*9 TWO YEAK ORAL &f)TET) ToxiCITY-ONCoOENICITY STUDY UF FLUOROCARBON FM-3y24 IN FEMALE RATS INDIVIDUAL "EMOGRAM VALUES ----------------M-ONTHCJ ------------------------------- HEMAT mcv mcm MCHC WBC PMNAS 42 5B.3333 211.112ciuo 36.4286 8*32 1,R-404 41 56.Oti?b 20*51YO 36.5054 16.90 2*8730 45 h3.4442 19@0"?1.30 36o8889 11000 0,9440 45 57*4713 26*3065 35*3333 13*30 1,5960 44 60.0273 21.Fl2RI 36-3636 17050 3*32SO 41 SS.7823 20*q.524 37.S610 Re52 0*7660 44 54.1872 20ooT39 37.04bS 14.80 1*1840 42 55.7769 20084(#9 31.3810 11*10 1.66so 42 S3.0973 19,3426 36.428b 9021 0*9210 44 58o4329 21.?4ti3 36.3b36 11.30 2,82SO 41 45,6062 16,6052 36,S8b4 20080 1,0400 4'3 58:5034 20*9524 35,8140 11:00 0:9900 42 hd*0913 21.%7ftS 37,1429 13990 0,69so 44 S7.5163 20.'101ho 36.3636 12960 401,iso 42 58.0110 20.4564 35.9524 11090 2*2610 44 5S.90RS 2n.sn4s 36oHlU2 14030 1*2ATO 43 sh.sing 20.@632 35*RI40 19940 3,8640 42 hslhsll ?o.j457 36.4206 24*40 1*4640 44 53*07bO 19.1004 36,3636 14*20 1,96RO 43 S5o989b 20.4427 36,5116 ITOSO lo?SOO 4? S4.4747 1944Sb3 3S*7143 IS.40 2olSbO 41 4l.lb47 15*2610 37.0732 14.10 1.2690 42 h4.9020 20.@536 37.6190 11-90 4*16SO 4S b7.1792 210 6928 3h.RB09 16*00 2,2400 4S 60.0801 22.O'2y4 36.6667 10*00 2,3000 44 SS*8376 20.,AI22 37,2727 12*20 2o4400 46 58.4498 22.P3h3 38.0435 8.47 1,0164 43 56.s789 2OoS2ft3 36.?791 2S*30 107710 43 57*1049 21*1155 36.97b7 19*40 3.4920 a% TABLE 13 TWO YEAR ORAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FM-3924 IN FEMALE RATS INDIVIDUAL HEMOGRAM VALUES ----------------------------------------------------------1-4ONTH26 --------------m------------- DOSE 0 ppm 0 ppm 0 PPM a PPM 0 PPM 0 PPM 0 PPM 0 PPM 0 PPM 0 PPM a PPM (P)POI 0 PPV 0 PPM 0 PPM 100 ppo ino ppm inn PP" loo PP" Ion PP" ion PP" ion PPM 140 PPM ]no PPV 100 PPM inn PPM Inn ppm Igo ppm 100 PPM 100 PP" ANIMAL NIR4582 NIR4584 NIR4506 NIR4590 NIR4598 NIP4603 NIP4607 NIR4616 NIR4619 NIP4621 NIR4622 NIR4629 NIP4631 NIR4632 NIR4639 OIR47S9 GIR4?6i) OIR4764 OIR4?71 OIR4773 OIR4774 GIR4??6 OIR4765 OIR4?06 GIR4794 GIR4798 OIR4803 GIR4808 OIR4812 GIN4814 ERYTH ?932 less 6*Al ?019 ?*31 ft.60 ?."A A*03 ?.To 6000 7*23 7.32 7.3fi 7*29 T.05 h.Sl 6.71 6.R? 6080 6.33 6.94 6.71 &ISS 7o22 ?*n3 6.91 7.14 6*RT 7.14 ?000 HEMO lb*O 15.f; 13*0 I!i.3 15.1 14,T 1508 14.6 IS.3 14.3 14.4 1501 14,A 15.1 15.4 1394 l3o2 14.9 1316 14o3 13.7 13.8 14.1 13*9 1403 14.1 13.? 13*R 14*8 14,9 HEMAT 43 46 39 43 42 40 44 44 44 42 41 42 40 42 43 3t3 42 40 39 41 42 40 42 41 43 41 41 40 42 43 mcv 59*7432 500590? 5?*268? 59*0053 57.4SbS 60*6061 5548376 S4.?945 ST*1429 6l,lb47 56*7082 57.37?o 54*3478 57*6923 6009929 bS&3717 62oS931 5R.2242 57*3he9 64e?709 6065187 b9o6l25 64,1221 56,7867 61*1664 1)903343 57*4230 5oo2z42 58*8235 6144266 mc" 2Oo4918 20.1214 20*2b43 2lo2?96 2006sb6 22*272T 2060soo 18.18-18 1908701 2lo4294 19,9170 20*6204 20*1087 2097419 21.9*40 20,5837 1996721 2lefiBBS .20.0000 22*5909 19*?406 20*Sb63 21.526T 19*2h2l 20*3414 i@0*4QS2 19018?7 20,0073 20,7203 21*285? MCHC 34.8831 34*3478 3593846 3S.5014 3S,9524 36,?500 3S.9091 33,1018 34*7727 34*0476 35,1220 35,9S24 37*0008 35.9524 3S,8140 35*2632 31,42M6 37.2500 34.8718 34o8789 32*6190 34,SOOS 33,5714 33,9024 33*2hS8 34.3902 33.4146 34,5009 35,2381 34.bSI2 wac PMNAB L 8159 0.68?2 7 6.45 O*SI60 5 6o24 1*9344 4 7095 1*1925 6 T*43 0*9659 6 ?*69 0.4614 7 6943 0*578? s 6.9S 0.4170 6 5098 O*S382 5 6*61 192559 5 4959 094131 4 14.90 4*?680 9 11*00 1*2100 9 4*76 1,0948 3 7028 8o60 TOST 4*64 596056 1 1*4620 6 loni6a s O*SI04 3 10*30 1*2360 8 9.96 1,4940 7 8e26 Oo9912 7 6171 0*9394 5 ?.4S 1.713S s 8.64 0.8640 7 9*OR loS436 6 7*17 I'SO57 4 B.S3 2.3884 5 ?*32 0,9516 5 12.?0 296670 9 8020 1*3120 6 CA TABLE 13 TWO YEAR OWAL IOIETI ToxICITY-ONCOOFNICITY STUDY OF FLUOROCAMBON,FM-3924 IN FLMALE RATS INDIVIDUAL HEMOGNAM VALUES ---------------------------------------------------w -------MONTH=6 ------------------------------- DOSE 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PP#4 30 PP14 30 PP" 3()PPM 30 PPM 30 PPM 10 PPM 10 PPM 10 PPM 10 PPTA In PPM I(P)P" 10 PPM in PP" in PPM 10 PPM 10 PPM in PP" to PPM 10 PPM in PPM ANIMAL RIR4A22 RIP4826 RIA4829 PIR4832 RIR483S RlA4e38 RIR49SO RIR4453 RIR48S4 RIR4AS6 R104958 RIP4860 RIR4467 R104968 RIP4470 SIR4R?3 SIR4876 SIP4477 SIR4870 SIR4881 SIP4887 SIR4890 SIP4891 SIP4898 SIR4901 SIP4907 SIR4912 SIP4913 SIR491S SIP4916 EPYTH 79320 7*4qO ?0790 ?0710 7*430 So?30 7*560 9.270 79900 80030 7.520 7.360 90190 8.7SO 8*190 7.640 ?.760 7.640 7*640 A.240 9*230 7oSlD 7*440 8*241 ?0120 7*260 7el9O 7*SSO Relso 7*240 HEMO 14.9 ises 14*6 14.8 isoo issi 14.7 ises 14.8 15*4 14.6 l3e8 IS.6 l4e6 IS*4 1400 14*9 14o3 15.6 15*7 15.7 isei 1593 1400 1507 14*3 1498 1508 15o3 15.3 MENAT 42 43 42 42 42 42 41 44 43 43 41 39 45 41 43 41 43 40 43 4S 44 42 43 39 4S 41 41 4S 44 43 mcv S7o3l7o ST.4099 53.9lb3 S404747 56o5276 4801100 S4.2328 47.4649 S4.4304 53.5492 54*5213 b2.9691 48.9663 46.BS?l 132.So3i 53.6649 55.4124 5?*3560 56.2827 54.6117 47.6706 SS.9254 S7,7957 41.3244 63o2O22 Sb.4738 b7o0236 59.3668 53.9877 59.3923 14CH 20.)Sb2 20.6943 18,7420 1901958 20*1884 17.2967 l9o4444 16.1206 18*7342 1901?"l 19.4149 18.7500 1h.9750 16.68S7 16.RO34 IM.3246 1902010 18,7173 20.4188 19.0534 17.0098 20*1065 29oS645 16.9002 22.0506 19*6q7O 20.SR41 2Ook443 18*7730 21,13eb 14CHC 35.476e 36,0465 34*7619 3S.2381 3597143 35o9524 3S.oS37 35,2273 34,4lR6 3S.sl4O 3S*6098 3S,3046 34,6661 35.6099 3S.6140 34.)4b3 34.6512 35.7500 36.2791 34.R$04 3S.6819 35.9524 35.SS14 35.R974 34soRO9 34,A7dO 36*0916 35*1111 34,?727 35,SB14 wac 5.96 lieso 11090 11.60 8o54 11-10 S.47 6*27 13olO 6069 S*61 7*67 6091 9.97 7.Rl 9*00 6.85 9.50 9*13 093A 6091 6*26 7041 6.52 4988 sell 6o6S 10070 9963 6o6S PMNAS 0.9s3b 2*3000 Oo9S20 0*8120 093416 1.4430 093262 007524 1,S720 29?746 0*3927 1,6107 0901292 1*3958 1,4839 100800 066ASO 107100 1*36QS 1.4246 le3R2O l.lS#p4 0*5926 1,9S96 0.9760 068921 le7290 2e8N9O I,IS56 0.9310 TABLE 13 TWO YLAR ORAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FM-3924 IN FEMALE RATS INDIVIDUAL HFMOGRA14 VALUES -------------------------------------------------------m--7- MONT"212 -------m-m-----------------0-.-- R)OSE 0 PPM 0 PPM 0 PPM 0 PPM 0 PPM 0 PPM 0 PPM 0 PPM 0 PPM 0 ppm 0 PP" 0 PPr4 0 PPM 0 PPM 0 ppm 100 PP" 100 PPM 100 PPM too PPM 100 PPM 100 PPM too PPM too PPM IGO PPM 100 PPM too PPM too PPM too PPM 100 PPM too PPM ANIMAL Nlk4ciTR NIR4582 NIR4585 NIR4SOO "IR4589 NIR4S90 NIR4601 NIR4608 NIR4610 MIR4620 NIN4629 NIP4630 NIR4631 NIR4632 NIP4640 GIN4757 GIR4?60 OIR4?61 OIR4763 OIR4?75 0194?T9 OIR47RO OIR4762 OIR4783 GIR478S OIR4?67 GIR4?88 GIR4?93 OIR4806 QIR4816 ERYT" 7.55 ?157 7.84 7923 7.94 7o44 7917 go26 7.3? 7.80 ?.R4 7.44 7160 7055 7o3o ?.40 To26 Tell 6*?T 605A ?.53 7.79 7.29 6.76 7*21 7o33 7o4l ?.86 7oO8 6,17 MEMO 15*7 IC)OT 1509 15*2 ISGI ir,.R 15.2 1693 iciel 15*3 16.0 15.6 isee 16.3 1506 14.T 14.s 13oR 13.7 13.9 15.1 1404 14*0 1392 14.ci 14.2 15.1 1506 13oA 12.6 HEMAT 44 44 45 43 43 44 43 4b 42 43 47 44 4S 46 45 44 43 42 41 41 44 44 4S 41 42 44 44 45 42 36 mcv S8027,41 58.1242 5?e3960 59#4744 54*1562 SYol390 59.9721 5506901 S7o3770 55*1282 59*9490 SY,1390 S8o5930 60.9272 61*6438 59.4s9s S9o2287 59.0717 6UoS613 62o3lOO SO.4329 Sb.55S3 61#7284 60*650Y SOo2524 6Goo273 59o3792 S7o2519 59o3220 SS*3468 MCH 20.794? 209?39d 20*2806 21*0235 19*01?6 21@2366 2161994 19o?337 20*6284 19obIS4 20.4082 2ft*9677 2005?29 2loSS94 21*36V9 1998649 1909725 19*4093 20,2363 21*1246 20oO53l 1805090 )9*2044 19-5266 20-1110 19o3?24 20,3779 1998473 19.4915 2004214 mcme 35.6818 35.6816 35,3333 35*34RO 3Soll63 3So989l 3S.3488 3SO4348 3So9S24 3SoSS14 34*0426 3So4S46 35-1111 35o4348 34*6661 3304691 33*7209 32o89TI 33.4146 33.9024 34*3182 32o72T3 31*1111 32*1951 34.5230 32.2717 34,3182 34.6667 32o847l 3SoOOOO WBC 3oS 699 491 3.9 6*6 504 4,6 TOI 3*8 5o2 12ol 605 509 4o9 5*2 Soo 600 504 Soo 502 see 809 Soo 3*4 4*6 6.4 596 49S 902 S09 PMNAB 0.840 Oo621 004si 0.390 3*?64 0.648 OOS98 01?10 DoIS2 O.IS6 6*171 lo365 1,239 1*666 Oo?28 06500 Qo840 los6b isiso 00416 2,262 loS13 00?00 0*236 OoS?4 lo024 Ool68 OoO45 Oo552 0,76T TABLE 13 Two YEAR ORAL IDIET) TOXICITY-ONCOOENICITY STUDY OF FLUOROCARBON FM-3924 IN FEMALE RATS INDIVIDUAL HEMOGRAM VALUES ------------------------------------------------------------MONTH=lb ------------------------------ DOSE 0 PPM 0 PP#4 0 PPM 0 PPM 0 PPM 0 PPM 0 ppm 0 PPM 0 PP?4 () PPM 0 PPM 0 PPM 0 PPM 0 PPM 0 PPM 100 PP" 100 PPM too PP" too PPM too PPM 100 PPM too PP" too PPM too PPM too PPM too PP" 100 PPM too PPM 100 PP" 100 PPM ANIMAL NIR4%81 MIR4583 NIR4sR6 NIR4S92 NIR4595 NIR4598 NIR4s99 NIR4602 NIR4604 NIP4606 NIA4609 NIR4611 NIR4612 NIP4627 NIR4638 QIP4?62 OIR4765 GIR4?72 GIR4?76 GIR4778 QlR47A9 OIR4794 GIR4801 GIR4RO3 GIR480? OIR4006 GIR4811 OIR4RI3 OIR4814 GIR481? ERYTH 6*16 ?052 7008 A,04 7952 7*44 7.80 7,72 ?.97 5.85 7.07 6.95 A,?? 7.36 7976 6,81 ?oS4 7*11 7.07 ?.10 6*91 6.73 6.89 6*94 3*IS 6o?6 6011 6.87 5.44 6,94 HEMO 1293 IS*6 14.S 1608 15.3 16*4 16*1 1606 16*4 12*4 15.S 14.7 16.5 16*2 16*4 14.4 14.7 14.7 15.1 14.7 14.5 14.4 140() 14.3 T.b 14.1 13.8 igi.1 1205 13.9 HEMAT 34 44 41 46 44 45 44 45 47 34 41 41 47 46 4s 41 43 43 42 43 43 42 40 42 21 42 40 44 35 42 mcv SS.1940 58.5106 57,9096 57*2139 SO*5106 60*4839 56.4103 5962902 SU*9711 5801197 576991s 58#9928 56.031Y 62*SOOO 5709RV7 60*2056 57.o292 60.47FJ2 59*4059 bOo5634 63.1424 62*4071 S800552 6095107 66.6667 62.1302 b5o4bb4 64,0466 64.3392 60.5107 19.9675 20.7447 POo48O2 7008955 20.34ST 22oO430 ?006410 71*5026 ?0*5772 21-1966 21-9236 2101511 19*9516 ?2.0109 21.1340 21*14S4 19.4960 ?Oo67SI 2le3ST9 20*7042 21-2922 21.39hl 20.3193 20ebOS2 24.1270 20*8seo 22*SBSY 21.9796 ?2-9?Ty ?0*0288 MCHC 3beIT66 3S*4S45 3S.3659 36oS217 34*7727 36o4444 36-5909 36-8889 34*8436 36*4706 37*8049 359OS3? 3S*1064 3So2l74 36*4444 35-1220 34*1860 34*1860 3So9S24 34*1860 3397209 34*2@ST 35&0000 34*04?6 36-1905 33-5?14 34*5000 34.3182 35*7143 33*09S2 WBC 13.2 502 417 6,S 493 Soo 4*6 fi,r, 4*9 Sol 4*9 593 7.0 5.0 3*R 9.0 3,S Sao 4eS S*4 soa 601 2*8 5*? loot Soo 592 5.9 6*6 717 PMNAS 6*600 0*208 OOSI? 1,690 10075 00200 0.384 o.195 0,441 1*632 Oo931 0*371 0*840 oooso 0*076 2.070 0,73S 10050 0.945 le404 1*392 102RI 0.504 1,S96 4,94Y iosso 19404 10?11 10716 2*464 CYI 00 TABUE 13 ------------------------------------------- DOSE 36 PON 30 pp" 30 PP$4 30 PPOI 30 PP" 30 ppo 30 PP4 30 ppm 30 PON 30 PP&S 30 ppm 36 PP" 30 PP" 30 PP" 30 PP04 to PPM 10 PP" to PON le pp" Is PP" is Pon to PP" Is PP" le PP" Is pp" to PP@4 le ppoq le PON to PP14 to PP" ANIMAL RIM4024 ala*82S MIN4432 alN6a36 PIR4$39 RlR4o44 plN4a4s R104446 Rlp4o4? M104649 OIR4&SS RIO*861 RIA4862 R104863 PIR4864 S144872 SIW46?3 SIN4876 SIR46?8 SIR4881 SIR4892 SIM4893 SIR4903 SIR4904 S104907 SIR*909 S144910 SIR*OIS SIR4916 SIR*919 ERYTM 6.8? 7.47 Te32 1944 7.6s 7.03 ?.09 S*95 109S 7.64 7.44 7021 6067 1016 $*is 7033 ?-34 long 7*93 7.62 7060 1-38 ?*?I 6os9 6.03 ?071 7*3? 7022 6062 8*08 MEMO 13efi lo.V 14*3 14.9 ISOO IS.4 14*3 liet 1?.o 14.s ISOI l3e9 14*3 isoi lses 1407 isei 1601 ls.s IS04 isol 1601 IS*6 16*2 IS*b 1600 14.4 iset 1494 1606 Ch @O TwO YEAR ORAL IOICT) TOXICIjY-ONC06EMICITY STUDY Uf FLIJOHOCANHON FM-3924 IN FE14ALE RATS INDIVIDUAL HEMOGNA#4 VALULS ---------w------- MONT"alo -------------------------v-------- "EMAT HCV mcm "C"C woc PMNAB LY 43 biesvio 10,0673 329OV30 I#S be.2410 19.44bh 33*illl S.0 ishoo 30 506 lobi2 30 42 5703770 190%3bs 3490476 504 1*836 1* 44 %991390 2000269 3306636 S*4 1,944 20 46 60*1307 200613'16 34.3416 301 00992 1* 46 65*4339 21*Vobl 33*4163 603 0094S 40 42 5902384 20*1693 34*0416 5*3 loS3? 3@ 3% 589623S 19@FJ639 33o*286 704 30404 ]a 49 61961S2 21*3636 34.6939 606 20ST4 39 47 6101979 IAO"802 3o.obli soy 104?S 4* 4s 6094039 20*?9sl 33*bSS6 700 ?0380 40 41 Sbo]961 19*1191 33o9Ga4 1469 100212 3* 41 5VO6798 20*"ISI 3400760 S*4 1*296 3* 44 6lo4s2s 2160094 34*3182 464 lo232 2* e#fi S6.6417 1900184 33964S? S09 l,sas 3o 44 6ooo2?3 2OeUS4b 33o48Vl 106 lo366 so 4s 61*30?V ?GIS?22 33*SSS6 ?08 20?30 30 4R 61.068? 240403S 33.S417 3*1 00?40 20 4t, saooolb l9os4bo 33,69ST 44 57.7428 ?00?108 3sooeso 1#02 10240 49 600 10260 4o 46 480SZ63 l9ombR4 3200261 1006 39186 60 47 6306"Sb 210disi 34o2SS3 601 lo$30 3* 4? hoo9s98 209233S 33*191to 3.S oes6a 2 49 S?90431 lil,"Sgl 33*0612 592 10664 3 ish SI.2oS2 1904211 33o9l3O 44 61.7761 2nob920 33o3333 bal seass 4 6*4 le9d4 3 47 63,7720 ?0,1)014 31.4894 3*3 isiss I 44 60.9*lh POOV141 3*.3182 702 2OS92 3 47 bleso3h 2101144 34.2867 ?01 20OS9 3 db9 60.6436 20.S446 33-d?16 606 1*914 4 TABLE 13 TwO YEAR ONAL IDIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FM-3y24 IN FEMALE RATS INDIVIDUAL HEMOGRAM VALUES ----------------------------------------------------------M-O-NT-M=24 ---------------------------- DOSE ANIMAL ERYTH HEMO HEMAT mcv MCH MCHC woc PMNAH 0 PPM 0 PP" 0 PPM 0 PPM 0 ppm 0 PPM 0 PP$4 0 PP#4 o Pam 0 PPM 0 PPM 0 PPM 0 PPM 0 ppiq 0 PPM 100 PPM 100 PPM ino ppq 100 PP4 100 PPM ino PP" Ion PPM Ion PPM ino PP4 too PPM 100 PPM too ppm too PPM too PPM 100 PPM NIR4583 NIR4586 NIR4S91 NlM4S9S NIN4598 NIN4603 NIN4606 NIA4611 NIR4614 NIN4616 N104626 NIR4628 NIR4634 NIR4636 NIM4638 QIR47%9 GIR4764 GIR476T GIR4?69 GIR4?73 OlR4TT8 ClIR4?94 0144796 GIR4800 GIN4803 GIR4809 QIR4811 OIR4814 GIR4817 GIR4619 7.48 7922 7091 7.97 ?943 ?00? T.?e 4-21 7.34 7*24 7,31 6921 4.86 7.90 7.99 6o3O SoR7 4.6FI 5*32 6.49 7.82 7904 7.62 3*62 6691 S.49 5*61 6*25 4*75 7074 IS*3 42 14.3 42 150? 45 IS*9 46 16*4 47 1409 44 15.9 46 10.3 29 16*0 44 ISo2 43 1405 42 l3o4 38 11.7 3? 1661 47 16*8 47 12-7 39 11*7 3r) 1093 30 )1.3 33 12.4 3A IS.4 47 14.S 45 13.9 43 809 25 13.1 42 1004 32 1109 35 1192 30 10.4 30 15*1 46 56.1497 So.1717 56*8900 S?o?164 63,25?1 62*2348 59.1260 68.8836 59.945S S9.3923 57.455S 61.1916 65.0436 59*4937 58*623S 6109048 59*6252 h4.1026 62*0301 58.5516 60.1023 63*9205 56.4304 69.0boa 60*25A2 58.2878 62.3886 hoooooo 63.15?9 S9.431S 20.*545 19.0061 19*"483 1909498 22.0727 21*0750 20.4370 24.46S6 21.1984 2a.4945 19.03SO 2loS7RI 2400741 20.3797 2loU2b3 20*158? 19*9319 2?.0085 2lo2406 19.1063 19.b931 200SY66 l8o2415 24*SB56 19.bssl lR.y435 21*2121 11*9200 21*0947 190bo9o 36*4206 3490476 34,0889 34*56S2 34o8936 3398636 34*56S2 3Sobl?2 36e3636 3So3460 34eS23" 3S*2632 36*562S 34o2SS3 3S*744T 32,5661 33*428b 3493333 34.2424 3?ob3lb 3297660 3292222 32.32S6 35*6000 324bi9o 32*5000 34.0000 29.4737 3496667 3298261 18.7 4.1 4.9 4*6 602 4.2 4.7 992 S.1 4.5 5.4 0*6 12*2 Soo 3*S 1.? 596 SOB 14.9 be2 4.3 409 499 l2o8 6*1 709 S*7 693 994 6*3 l2eS29 10148 0973S 2,714 2o232 10092 10081 3*496 1.969 2011S 20592 3,870 S*246 106so 0*630 2oS41 0,?84 2*146 11*622 1.488 oo9A9 29058 1*470 4,3S2 2*13S lo343 20907 IOSTS 1*410 l*S7S TABLE 13 TWO YEAR ORAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCAROON FM-3924 IN FEMALE RATS INDIVIDUAL HEMOGRAM VALUES ------------------------------------------------------- MONT"924 --------------------------- DOSE ANIMAL ERYTH MEMO HEMAT mcv MCH MCHC wac PMNAS 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PP" 30 OPM 30 PPM 30 PPM 30 PP#A 30 PPM 30 PPM 30 PPM 30 PP" 30 PPM to PPM in PPM 10 PP" in PPM 10 PPM 10 PPM 10 PP4 10 PPM 10 PP14 10 PP#A 10 PPM 10 PPM In PPM In PPM 10 PPM RIR4022 RIR4626 RIR4827 RIR4932 RIR4834 RIR4836 RIR4839 RIR4844 RIR4847 PIR48SI RlR48S4 RIR48SS RIR4059 RIP4864 RIR4669 SIR4872 SIR4873 Slq4876 SIR4881 SIP4882 SIR4004 SIR488S SIR4892 S104894 SIP4897 SIR4903 SIR4914 SIP4916 SIP4918 SIR4919 3.29 6.39 607S 7.3A 600S 7007 7.33 6.00 ASIO 1*52 6*40 ft*RT 6.95 sell 7.09 6oS3 7.11 6096 7.78 fi.68 6011 7*64 6*39 7*73 7,47 Ao04 6,71 6902 C;thl 7954 8.1 26 1315 39 13*4 40 13.9 43 1207 38 14*6 42 1500 .45 IS02 44 lo*C) S3 S.6 13 13.o 40 14.6 42 1499 43 IS.0 44 13o? 40 13.2 38 14.7 43 14.6 42 IS.1 44 14.R 41 13*3 39 16*1 45 13*0 39 17.0 45 15.7 47 16*3 4? 14.8 42 13.2 38 12.7 36 16ol 44 7960274 filoo329 S9e2h93 S862656 6248099 S9*4059 61#3915 64*7059 6S*4321 85%5263 62*SOOO 61*13S4 616870S S4e2540 56*41?S 5801930 60*47R2 60%3446 56%5553 61#3772 63*0298 5"09005 6160329 SA.?147 62*9183 59*4577 62oS931 63*122q 64*1711 SA*3554 24.6201 21olebe 19,BS19 18,8347 2099917 20.6SO6 20,4638 22*3h29 22o8395 36,0421 20*3125 21.2518 21.4388 IR.4')Sl 19.3230 20,2144 2016?Sl 20o9710 19*4087 ie2elb5T 21,7676 21*0733 20*3443 21*9422 21.0174 20*?736 22.0566 21,9269 22.6381 21,3528 31,1536 34obIS4 33oSOO6 32.32S6 33.4211 34.7619 33.3333 34,S455 34o9OS7 43.0169 32.5006 34,7619 34,6512 34*0909 34o25O$ 34,7368 34,IH60 34.7619 34.3182 36,0976 34,1026 3S.7778 33,3333 37.7778 33,4043 34.6009 3S*2381 34,7368 35.2776 36,5909 ISIS 7.2 sts 6*9 3.9 SIB 3o9 12*3 17.4 2Re4 10.1 4*2 5.5 7.6 isei S*4 3*9 5oO 4.9 9.3 12ol slo 14*1 401 7,4 2*R 7*6 1093 5.9 3*9 11.625 3olbb 1.44S 1*963 lo482 10656 o.A97 R.364 IS*486 l9oo26 S.4S4 29S20 2*860 2o964 9.060 10080 0.997 10200 0.833 40650 6,897 1.100 2*820 Oo779 2*146 Oo28O 2*280 3o296 1*062 0*624 MALE TABLE 14 TWU VEAN UNAL lfilET) TUXICITY-UNCUL7LrvICITY STUUY OF kLUUPCUCAkHON FM-3924 MLAN ULUCUSE IMG/UL) BLOOD CHEMISTRY i VALUES 6LOOO'OHtA NITHOUTN I (Mb/DL) ALT (IU/Li N MEAN S.I)LV. MEAN S.DEV. MLAN S.DEV. IN HA 04EAN MONTH 3 0 Rpm 100 PPM 30 PPM 10 PPM MONTH 6 ppm loo Ppm 30 polo 10 ;-Wm 15 120.b 15 129.5 IS I?d.4 15 12U.1 13.74 11.70 14.17 9.kii lb.3 16.5* 19*1* 18.20 1.64 1.3b 1.9if 2.01 al.4 2Y.10 27.1op 30.40 2.67 5.47 5.92 9.68 4b.3 !)2.2 SI.2 57.9 is llo-O 15 illi.4 15 135.19 14 12Y.3* 13.i!v 6.2y 14.20 9.42 17.5 17.3 1713 16." 1.36 2.610 I.b? 1.47 ie##.1 62.10 30.7 132.0 3.75 25.,44 12.30 11*68 49.7 74.7 53.3 b9es MONTH 12 loo Pkm 30 Pem 10 PF-4 14 154.3 14 137.5 Is 140.9 IS 151-3 Zlb.IT 17.01 17.liti 27.bv lb.4 1701 1707 ilev ?.50 1.44 2. 04e I.zb i3.5 65.2* a9ob 63.9 19.45 31.20 12.S@j 23*37 79.1 163.2 71.1 ?6.7 MONTH IN 0p loo PP" 30 Pel4 10 PPIM 15 123.4 Zb.39 15 131.1 iso.bl 15 144.9* 16.54 15 146.1# 21*34 lbol 15.41, 15.7* 17.3 3.38 1.5v 1.83 3.Zlo 44.1 66.1 bb.o* *5.8 10.68 25.40 23.Sl 13*33 99.1 63.1 75.b 63.4 MONTH 24 100 PPM 30 PP" 15 I?Z.b 15 110.1 15 1?2.3 23.07 20.Vl 25-ii! lb.5 15.8 15.9 3*lb 2.04 5.30 33.4 67.16 al.2 8*10 42*10 14,62 b4.Q 95*8 67*9 -4 10 PPM 15 12b.6 2b.52 lo.4 9.19 30.2 7.83 74.3 .09@. Tw(i TAILED UUNNLTT T ON RAW DATA. <z .05. loU TAILEii DIIN#vLT1 T Uiv KANALI) DATA. MALE MUNTN 3 (i PP" 100 PPM 30 PiAm 10 POM MONT" 6 0 PPM 100 PPM 30 PI-M 10 POOM MUNTM 12 u PPOO luo Pem 3t) PPon 10 ppm MUNTM IP 6 PP04 100 PION 3u Pi-m I U P$014 MUNTM 24 0 PF.04 100 PP14 3o PP)m I(# PION TABI.E 14 MEAN TwO YEAH OHAL it)IEII IUAICITY-UNCUbEt4lClTY tsLOOD CNLMISTHY VALULS (TbILIt ALbt YPNOto STUUY OF FLUUWUCANEOUN F04-3c#24 IN ALAPHOSE CPK# CA) W17H STAt4UAWD TUTAL BILINUUIN fMb/i)L) IV MEAN S.DEV ALBUMIN (6M/DL) HEA14 S.ULV TUTAL PHUTEIN (6M/DL) MLAN S.ULV ALKALINE PHOSYNATASE IIU/L) 04EAN S.Ufv CREATINE PMOSP"OKINASE (IU/L) MEAN SEDEV is 0.6 O.lh Is O.vo 0.22 is 1.00 0*26 is 0.9* 1.24 4.4 4.90 4.!) 4.:$ 0.34 0.27 0.18 O.?o 6.11 6.9 696 bob 0.34 O-L'b 0.1d 0*24 91.1 133.9* 130.7* l@sa.b* 26024 44.bV 40.24 24.06 100.7 79*4 111.4 IOS.5 26.46 29@87 9SO63 32490 Is o.b 0.19 is 1.20 0.4b Is 0.6 0.1b 14 0.,o 0.22 4.b 5.4* 4.7 0.20 0.19 0.39 0.20 7.0 7.3 I.o 6.9 0.36 0-23 0026 0.24 97.1 121*2 117.7 112.1 40041 37*30 33*ob 23932 89*9 111.7 52.1 99.5 41932 60*53 20656 53640 14 0.7 0.20 1,* 0.7 0023 Is 0.7 9.16 is 0.6 0*17 3.7 4.00 3.b 3o? O.kfi 0.30 0#?4 0.20 bob b.? b.? 6050 0.27 0025 0.27 0.2? 105.0 133.1 12116 IOS.? 43.vft 39.1* 39046 75.6a 7907 58*2 59*3 112.6 47061 lSo39 18o?V 134,42 Is 0*9 oe3b Is 0.64 0.14 is 0.40 0010 15 0.54 0012 3.2 3.6* 3*4 3.4 0*36 0.31 0*14 0.20 7.1 0-bi OS.k 33.7% 7.1 0.1to 20602 3vd*66 7.4 0.4s 79.5 51.44 7*3 0-27 77.!i i9edi 79.9 4T,S 2b*ho 4,2.10 74.52 12*69 12*4b 28*6b 15 0.4 O.?b Is 0.4 D.OY is 0.3 0.12 is 0.4 00?2 3.3* 2.v 2*Y 0.27 0.31 0032 b. @o 761 bob b.7 0.44 0.42 0040 O.b? 70.1 103,5* 82.7 69.1 26.53 SO.lb Bl.b3 40013 111.1 101.9 75.0 84*9 66.0* S201Y 23*3b 23&Sb P cx .059 TooO IAILEN OUNNETT T ON HAN DATA. oD')o TWO IAIL[F) ttt)NNETT T ON kANI(Lil LIA7A* TABLE 14 TwO Y@A14 OKAL (f)IET) TOXICITY-ONCOOENIOITY STUOY OF FLUOROCARNON FM-3924 IN MALE MATS INDIVIDUAL PLASMA CHEMISTRY VALUES ------------------------------------------------------------- MONTH=3 -------------------------------- DOSE a PPM 0 PPM 0 PPM 0 PP" 0 ppm 0 PPM 0 PPM 0 PPM 0 PPM 0 PP" 0 POM 0 POM 0 ppm 0 PP" 0 PP" 100 PP" 100 PPM lno PPM 100 PPM Ion PPM 100 PPM 100 PPM ion PPM 100 PPM loo PPM Igo ppm 100 PPM ioo ppm 100 PPM 100 PPM ANIMAL GLti HIIN ALT AIR3514 112 17 20 AIP3527 AIR3S32 140 21 ?2 138 1? 20 AIR3534 112 IT 22 AlR3S3? 129 is 28 AIR3540 102 17 21 AlP3S42 111 14 22 AIR3S48 ve 14 21 AIP35%2 141 16 is AIR39%9 ion IT IN AlR3S62 130 16 21 AIR3564 12S Is 24 AI"3565 129 17 20 AIR356? 114 15 19 AIR35f@9 ' 120 14 29) DIRITOI 14? 18 3Z DIRI?03 112 17 22 DIRI?05 152 14 29 OIR3706 13() Is 26 D103711 IIFI 19 29 DIR3?14 lie In 34 DIR3719 14r, 17 24 nl"3723 124 20 20 nIP3724 134 19 40 nl"3727 135 16 25 DIA3734 IPO 20 37 DIP3?40 127 19 30 DIP3?48 135 17 30 OIR3749 1?3 14 2h DIR3?54 123 21 32 AST THILI im 0.6 42 095 36 o.Y so 0." 59 oes 42 oes 43 001 46 o.S 38 oos 44 0.5 51 not# so n.8 47 0.9 36 0.6 sil 007 S4 009 38 no6 52 0.9 49 007 49 1.1 57 101 37 004 36 1.0 67 1.2 1#1 a.? 55 0*6 64 009 53 008 ft? 102 Sfo 400 ALH 4.2 4.4 494 Sol 4e4 4*1 4.4 3*9 402 4.4 4.1 Sol 4o6 402 4*3 S*4 406 Sol SOO 4.9 so? 4.5 4.s Soo 4*6 4.R 5.1 4*6 1#*o Soo TPROT 6.4 606 7.1 ?*8 696 6*S 69? 695 688 606 6.S 6.6 668 6*5 loo ToS be? 699 699 7*0 Too 609 6*S ?01 6*6 60(# opos 6o9 6.9 6*6 ALKPHOS 107 106 SR 105 100 no 60 12S 71 S2 73 125 128 fig lea ITT 59 132 Ise 114 62 IRS 76 140 170 146 123 144 113 109 -4 TAnf.E 14 TWO YEAR ORAL tt)IEYI TOXICITY-ONCOOFNICITY STUUY 4)F FLUOWUCARFION FM-3924 IN MALC MATS INDIVIDUAL PLASMA CHEMISTRY VALUES -------------------------------------------------------M-ON-T-H=-L-- ----------------------------- f)O%E ANIMAL GLU RUN ALT AST THILI AL#4 TPROT ALKPHOcs 30 PP" FIR3761 156 in IY 44 1.1 4.f2 6.s 30 PPM EIR3??O 109 IR 3S 48 1.6 4.8 &.A 30 PP" EIR3?71 152 21 32 62 0,0 405 607 30 PPM EIR3??3 120 22 23 36 0.'3 4o3 605 30 PP04 EIR3774 119 21 3h TO 1.1 40? 609 30 PP" EIR3??O 119 16 32 47 0.0 4.4 6oS 30 PP" EIR37RO 141 21 30 52 192 4.4 6.5 30 PPM EIR3793 12S 19 34 62 1.2 404 6*5 30 PPM EIR3?07 120 1? 26 30 PPM CIP3740 142 ?a 20 41 0.7 4efi 695 39 00" 4*h ?.0 30 PP" EIR3?91 126 20 24 44 1.1 4.3 6*gi 30 PPM ElR3?q6 124 19 24 36 O*h 4.6 6.5 30 PPTA FIR3ADO 137 1(1 23 4#6 a." 403 6*4 30 PPM Elp3pol Ila 21 24 so 101 498 698 30 PPM FI"3806 126 16 22 43 o.q 4." 6*? 10 PPM FIRIA)L 111 20 24 60 0.9 4.7 6.R 10 PPM FIR3915 126 is 27 in PPM FIR3010 12r, 20 2S 43 0*" 49c) 6.7 47 101 4.2 6*h 10 PPM FIR3822 126 10 32 63 0.7 4.4 6*7 10 PPM FIR3R?4 133 16 25 10 PPM FIR3R3l 130 114 32 so f).? 4.3 6#6 62 0.0 406 ?.a 10 PP" FIP3R32 120 IN 33 sm oeq 403 694 10 PPM FlR3A34 114 19 29 64 1.2 4.6 hob 10 PPM FIR3R36 112 17 63 12" 0.? 4.1 6.6 10 PPM FIR3A39 IOR 20 ?3 36 a.? 401 691 10 PPM FIR3R39 IPA 2? 2" 40 0.7 404 6*3 le PPM FlR3A4O 120 1? 23 53 1.5 403 606 10 PPM FIR3R44 121 20 30 59 0.6 4.s 606 10 PP$4 FIR3847 127 18 29 71 0.9 4.1 f)OS 10 PPM FIR39S2 100 is 33 Sh 0.8 4*1 6*3 JOT 12S 168 124 li? 172 140 ISO 123 ?a 170 ISO 92 99 so isi 133 los 110 139 176 169 122 IP3 134 10? 134 13S 128 IS4 TABI,E 14 TWO YEAR OKAL 4DIET) TOXICITY-ONCOGFNICITY STUDY OF FLUORUCAOSON FM-39?4 IN MALE MATS INDIVIDUAL PLASMA CHEMISTRY VALUES ------------------------------------------------------------- MONYH=H m ------------------------------ DOSE 0 ppm 0 ppm 0 PPM 0 ppm 0 PP" 0 PPM 0 PPM 0 PP#4 0 PPM 0 PP" 0 PP" 0 PPM o PPM 0 PPM 0 PPM 100 PP" loo PP" 100 PP" 100 PPM 100 PPM 100 ppm 100 PPM 100 PPM 100 PPM IOD PP" 100 PPM 100 PPM loo PPM 100 PPM 100 PPM ANIMAL AlR3r#19 AIR3%24 AIR3r.29 AlRici33 AlP3S3? AIP31;41 AIR3r)47 A143SSO AIR3553 AlR3Sri? AIR38;S9 AIR3%62 AlR3S67 AIR3r,?3 AIR3575 F)IR3696 f)IP3103 DIR3?07 lilp3lio r)IP371f, F)1"372" I)IRIT31 nIN3733 nIR3?34 DIPI?36 DIR3?38 nlP3T43 F)IR3746 F)IR3754 nIA375? GLTJ 133 139 130 124 109 124 115 120 99 109 100 133 129 102 111 loli ios lic; 111 104 103 IOFI 114 110 113 1011 Ila 111 103 I?t% Hilt4 19 17 16 19 16 le 19 Is 20 17 17 In 114 17 17 is 14 19 16 le 16 In In 19 22 17 17 14 In is ALT 114 4el 20 20J 27 19 29 25 29 22 21 28 23 26 25 22 43 121 49 29 31 34 43 31 76 27 2R 29 11 31 AST 34 S4 25 41 so 3s 28 43 r,3 74 si 55 49 74 67 37 AO IS3 74 S4 so 040 100 Al I?b 49 55 60 64 49 THILI 0.6 no" Oeh 00" 1.1 o.? lei nof) 0.7 1.1 1104 006 0.0 1.0 007 291 0.7 102 101 107 lo2 O.h lei 1.0 1.1 105 0.4 100 004 1.6 ALM 4.3 4.4 4.7 4*fl 4.9 4.s 4.8 4.T 4.6 4.7 &.S 4*? 496 Soo 404 Sol 594 5.3 S.5 '3*Y 5.3 S*4 Sao So3 S*2 5*4 S*6 5.4 S.6 S.4 TPROT 6.4 7-3 697 ?.S 7.0 7*2 les 700 ?*1 Te3 69? 6*6 6.8 ?*S 607 ?o3 ?*4 702 7-2 706 7*S ?e3 699 607 T*4 704 ?*2 ?01 ?o3 7*3 ALKPHOS 123 109 72 RS 110 bs 114 213 62 120 so 69 69 lip To 121 62 171 100 133 14S 106 149 176 121 172 S? 84 103 lie TABLE 14 Two YEAR ORAL 401ET) TOXICITY-ONCUOFNICITY STUI)Y OF FLUOROCARBON FM-39Z4 IN MALE MATS INDIVIDUAL PLASMA CHEMISTRY VALUES ----------------------------------------------------------M-ON-T-H=6 ------------------------------ OOSE ANIMAL GLII RUN ALT AST THILI ALH TPROT ALKPHOS 30 PPM FIP3762 111 17 33 52 006 4.Y 609 30 PPM FIR3?63 116 19 43 ?4 Q.S 46? 7o3 30 PPM FIR3T64 143 lfi 42 64 o.S 4.? 702 30 PP" E143?65 138 IR 26 49 nos 404 6*7 30 PP" EIP3?70 130 19 24 53 0.8 4.8 607 30 PP$4 EIR3?73 131 17 is 21 0*6 4.0 6*6 30 PP04 EIR3?74 124 20 41 RO 007 Sao 793 30 PPM FIR3779 142 19 21 43 096 406 607 30 PP" EIR3TR4 141 16 17 32 0." 409 707 30 PPM EIR3792 116 is S9 102 O.S 404 7.0 30 PP" FIR3?94 Ise 16 19 32 no? Sao ?*1 30 PPM ElP3RO4 159 16 2? 33 0." 401 6oS 30 PPM 30 PPM FIR3RP6 EIRIODO 137 Is 24 147 17 28 47 1*0 So3 7*1 46 004 401 6*9 30 PP04 FIR3910 135 19 42 In PP" FIR3811 1)" 17 20 10 PPM FIRIRlb 1?6 14 23 10 PPM FIRIP17 131 is 22 72 006 Sao 7.1 4% 1.2 son 707 3y 0.11 4oM ?02 35 0.7 4*H 6*9 10 PP" FIR3A23 lie le 40 10 PPN FIR3"?6 146 is 30 10 PPM FIR3827 122 is 23 10 PPM FIR3R31 133 17 33 10 PPM FIR3R33 13r, 19 20 In PPM FIR3834 125 17 41 10 PPM F)R3P3? 131 16 32 10 PP" FIR3839 132 19 60 10 ppm FIR3A46 133 17 23 S2 0.? 4*3 6*R S9 009 4.S 6.n 40 0.9 409 6.fi 49 n.9 4.9 ?.2 3r3 oes 408 6o? ?3 1.2 4o9 yo3 64 1.0 Soo 6*9 85 0." 4eFl 607 49 1.2 4.7 ?at le PP" FlR3PS3 112 16 24 39 non aoh 6o9 la PPM F143RS4 132 16 52 134 0014 409 ?at 10 PPM FIR3A5S 145 1" 29 95 oos 406 606 118 IR3 1)" 118 12S P2 111 126 131 ITS 122 127 S2 "9 As to? 134 91 76 ISO 110 151 94 I;pq lie 101 Ts 122 12S 107 14 TART,E 14 TWO YEAR ORAL tl)IET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARRON FM-3924 IN MALE MATS INDIVIDUAL PLASMA CHEMISTRY VALUES ------------------------------------------------ -----------MONTH212 ----------------------------- DOSE ANIMAL OLU 01#N ALT AST TRILI ALB YPROT ALKPHOS .0 PP#4 AIR3516 147 14 22 56 Q.9 3ob 6*9 0 ppm AIR3SIT ISO 16 16 40 0.5 300 701 a PP" AIR3520 124 16 15 43 004 396 606 0 PPM AIR3522 134 is 65 123 006 3ol 6*? 0 ppm AIR3S27 iss la 37 67 0.6 3-9 668 0 PPM AIR3S35 141 1? 23 S6 0*6 3*R 6.8 0 PPM AIR3543 183 17 33 as 1.0 3.9 T.o 0 PPM AIR3546 ITR 17 3? 118 n.9 4.0 6.9 0 PPM AIR3550 iss 1@ 32 79 1.0 3-9 699 0 PPM AIR3551 lbs 20 41 an 0*6 3*9 6*7 0 PPM AIR3554 214 is a? 21? 006 3*S 6*3 0 PPM 0 PPM AIR3568 AIP3570 123 14 125 9 1" 43 0.1 3o3 692 23 S4 Q.S 3*6 6*S 0 PPM 0 PPM AIR35?S AIR3SOO 143 16 148 17 23 63 004 3*S 699 31 59 o.? 3,9 ?*1 100 PPM DIR3696 Ila 19 79 92 o.? 490 7.0 100 PP$4 DIP3699 12S 19 66 ?8 o.? 400 ben 100 PPM DIR3711 132 16 94 96 0.6 4*2 Too 100 PP" DIR3?14 130 16 62 9s 0.6 4.S ?so 100 PP" OIR3?15 133 Is 84 90 006 307 6*3 Joe ppm f)IR3?20 Ila 18 32 S3 0.8 4.s Too 100 PPM DIR3721 136 16 40 74 0.7 39T 697 100 PPM nIR3?22 145 1? 34 S2 o.? 3*5 fie4 too PPM DIP3727 141 17 40 69 0.6 4*0 606 100 PPM nIR3T32 115 16 31 so 0.9 3*6 693 100 PP#4 DIR3?33 165 20 h3 73 0.7 4.0 6*7 100 PPM nIR3?36 165 la 43 60 I.S 4*0 6,? 100 PPM DIR3737 140 16 83 RO 0*6 495 696 Ion PPM nIP374? 132 17 147 155 n.? 3-9 6.6 100 PPM 0143?48 )68 16 so 131 006 3-9 ?00 139 104 49 106 102 113 its to? 22S 9s so 48 72 ?0 152 IS9 16S 114 79 129 192 91 ?I 144 IS2 ISO ob ISO its 192 TABLE 14 TWO YEAK ORAL (DIET) TOXICITY-ONCOOENICITY STUOY OF FLUOROCARHON FM-3Y24 IN MALE MATS INDIVIDUAL PLASMA CHEMISTRY VALUES --------------------------------------------------M-ON-THul2 ------------------------------ DOSE ANIMAL GLU HUN ALT AST THILI AL" TPROT ALKPMOS 30 PPM FIR3?69 13? 24 20 4" 0.13 3.9 6.6 16? 30 PP04 EIR3??S 13S 16 36 79 0.6 3*0 607 68 30 PPM FIR3??6 lie is 41 a? 0.0 4*1 ?*2 AO 30 PP14 EIR3??9 133 17 44 ?2 0.6 4.0 ?00 134 30 PP" FIR3?RO 12% In 23 64 0*6 3*5 Too 144 30 PPM EIP3?62 123 17 46 an 0." 3.6 6*3 113 30 PPM FIR3?91 176 In 3S SA Ion 3.ft 6.5 1?4 30 PPM EIR3?9? 123 17 66 87 008 3*8 609 IRI 30 PPM EIR3797 141 16 S? 76 009 4*0 &OR IS4 30 PPM EIR3800 IS? In 29 S? 007 3*7 665 ?b 30 PPM EIR3002 152 in sa 76 oes 3*4 6e3 120 30 PP" EIP3003 147 In 30 60 006 3o9 6*4 136 30 PPM EIR300S 124 19 is fig Oofi 3*6 604 109 30 PP" EIR380f) 172 17 26 47 0.6 4*3 607 S4 30 PP" FlP3AOR IS6 1? 41 73 0*4 3.6 607 114 10 PPTA FIP3RI2 IS2 In 41 In% 016 3-3 698 109 10 PPM FIR3A)3 134 jr, 34 49 ots 3*8 6oS ins 10 PPM FIR3$14 163 20 44 ar 0.6 3*1 6*4 140 10 PPM FIR3815 157 In 112 14? 0.1) 3ofs 6*2 133 10 PPM FIR3AlA 222 17 26 60 o.1 3*S 606 64 10 PPM FIR3920 141 In 71 135 006 3*ft 609 104 10 PPM FIR3A2R 216 19 29 aft 0.? 305 600 94 10 PPM FIR3032 131 1? ss 67 094 3*9 6*4 151 in PPM FIR3633 154 In 26 47 4*4 3-9 6*6 so 10 PPM FIR3935 )too 20 2h 68 006 393 6*3 124 In PPM FIRIA39 139 is 40 44 0*4 3-S 6*1 90 In PPM FIR3A44 135 19 33 51 0.01 3.8 6*7 120 le PP" FIR3046 133 IT 35 69 006 3.7 6*? 68 10 PPM FIR3A4R isi 17 2s 53 Q.b 398 6*3 116 10 PPM FIR3A6O 172 1" 61 Ion 1*1 309 be? R? TABLE 14 TWO YEAR OWAL 40JET) TOXICITY-ONCOGENICITY STUI)Y OF FLUOROCARBON FM-3v24 IN MALE MATS INDIVIDUAL PLASMA CHEMISTRY VALUES ----------------------------------------------------------M-OP-J-TH=IH ------------------------------- DOSIE ANIMAL OL(i FIIIN ALT AST THILY ALO TPROT ALKPHOS 0 ppm a PPM 0 PP" 0 PPM 0 PPM 0 PP" 0 PP" 0 PPM 0 PP" 0 PP" 0 PP" 0 ppm 0 PPM 0 PPM 0 PPM 100 PPM Ion ppm ]on PPM too PPM 100 PPM 100 PPM 100 PPM 100 PPM 100 PPM 100 PP" 100 PPM too PPM 100 PPM 100 PPM 100 PPM AIR3519 AIR3521 AIR3526 isi 19 12ro 29 14A 19 AI"3531 AIR3%38 143 1" 129 is AIP3539 132 If$ AIP3S42 107 le AIP3giS2 117 21 AIR3553 127 17 AIP355r) 140 17 AIP3rbl 135 IT AlR3r)fiS 126 is AIR3567 134 17 AIR3574 91 17 AIR3ST7 46 17 nIN3697 nIP3700 120 14 115 is nl"3?07 128 16 nIR3TIJ 149 14 DIR3?17 0103723 nlR3T24 170 17 139 19 160 14 nIP3730 130 Is nIP3?31 87 is nIR3?39 IIA is nlR3T40 134 16 nIR3?46 12F, 14 DlR3TS1 01"3755 130 14 124 14 nlP37S6 138 Ito 41 94 59 317 2*# 55 1#2 9" 30 93 21# 54 30 61 23 S4 44 74 3S F14 26 61 23 62 34 133 24 79 4s 160 21 42 91 1" 101 as bo 63 Sh 68 17 34 22 71 30 46 20 40 3#1 06 45 bm 30 61 t,7 91 b3 60 32 46 0.1 3.2 0.2 201 0*6 3.2 100 304 aer 393 009 3*7 111 3.4 101 3.3 009 3.4 101 3.3 0*10 3*4 o.9 3*3 0.9 3*2 0.2 2*6 106 3*4 006 3*8 o.b 3*S nos 3.9 0.6 3*5 0.14 3*8 nos 3*S O.b 3.0 0.5 4.0 ".S 3.6 008 3#7 0*6 400 0.!) 3.5 oos 392 0.,4 3*1 009 3.7 6.8 SOS loo ?.4 6*t) Sol 7*2 7*4 TOS 7*3 ?-6 606 To? 697 7o3 6.9 6*9 701 7-3 ?*S 607 601 ?to 702 ?02 ?o3 609 6.9 699 109 129 lfi4 sy S6 113 R2 41 ss 6S 1?4 QQ 87 66 82 6R 64 119 136 90 143 63 1644 101 94 130 90 74 144 R? 114 00 TABLE 14 TWO YEAR ORAL IDIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCAN40N FM-.39?4 IN MALE RATS INDIVIDUAL PLASMA CHEMISTRY VALUES ------------------------------m ----------- -----------------MONTHZ]H ----------- ------------------ F)OSE ANIMAL GLIP SUN ALT AST THILI ALM TPROT ALKPMOS 30 ppm 30 PP" 30 PP" 30 PP$4 30 PP" 30 PP#4 30 PP" 30 PPM 30 PP" 30 PP" 30 PP" 30 PPM 30 PPO 30 PP" 30 PP" 10 PPM 10 PPM 10 PPM In PP04 10 PPM 10 PPM le PPM 10 PPM 10 PP04 10 PP" 10 PPM 10 PP14 10 PPM la PPM 10 PPM FIR3T62 FIR3T64 EIP3ThS FIR3?6? EIR3769 EIR3??l EIR3??3 EIPIT?S EIR37?7 EIR3?42 EIRITA? ElR3T93 EIP3?96 FlP3Pn6 EIR38n? FIR3RII FlR3Rl3 FIR3AI4 FIR3R23 Fla3A25 FIR3R3? FIR3839 FIR3442 FlR3A4S FIR3R48 FlR3ASI FIR3852 FlP3RS3 FIP3ASS FlP3AS9 160 16 inn Is 112 13 147 1? 149 Is 161 is 142 20 129 17 14S 16 12S 14 160 IR 144 Is 140 14 ]3r) 14 144 17 162 14 146 16 169 19 83 26 140 16 Is% 16 146 17 139 16 ISO IR 160 16 147 16 130 16 I?? 19 147 16 141 16 34 65 66 114 so T9 !)? ST 4? S? 64 76 79 3A 34 3H 47 47 Ila 177 S4 66 bfb To so 64 39 4? 97 135 so 62 tvfi 79 34 ST 33 37 3f# so 41 61 r.6 77 46 ?4 31 so 36 47 36 52 3S ss 65 91 916 92 bil 61 nob 3-6 7-2 Got, 3,f# Soo 063 3.5 ?OR 004 3eS 7.4 nos 3.4 Soo Gas 3*S ?.h 004 3al ?01 004 3.3 TOS 004 3.4 eel 0*3 3*5 606 n.3 3.S 6*9 nes 3*Ci ?OS 0*3 303 ?01 ols 3*6 yes 004 303 6*9 nos 3-5 7.4 0016 301 ?-3 001) 3-6 7*3 Q.S 2*9 103 nos 3*% ?o3 406 394 7.1 o.S 392 609 O.S 3-5 ?o3 0.4 3*4 Top 0.1 3sh 708 096 391 ?06 006 3.5 ?01 003 3*S ?on 0,3 3.1 6*9 0*3 3*2 ?*3 03 AS 49 76 94 9R 51 re 106 34 93 S? 139 41 IPS 82 79 in? 13 72 al ?5 6s 49 74 R3 R? ]is ?S as 00 TABLE 14 TwO YEAR ORAL (DIET) STUDY OF FLUOROCARBON INDIVIDUAL PLASMA TOXICITY-ONCOOEHICITY FM-3924 IN MALE MATS CHEMISTRY VALUES ------------------------------------------------------------MONT"924 ---------------------------- DOSE ANIMAL GLU RUN ALT AST T141LI ALR TPROT ALKPMOS 0 PPM AIR3%18 130 14 26 52 0*2 2.6 6.6 0 ppm AlR3S24 13A 23 29 42 0*6 2.? Tel 0 PPM AIR3S28 141 is 28 4? 002 3-0 608 0 PPM AIR3531 109 14 36 6(1 0*3 3ol ?01 0 PP14 AIR3S34 6? 20 21 142 003 2*? 509 0 PPM AIR3538 14? 12 38 69 0*2 2*8 6*4 0 ppm AIR3542 96 is 35 so Oo6 3*0 ?80 0 PP" A103S4R 122 is 32 48 004 209 ?00 0 PPM AIR3SS4 Ise 1? 43 74 002 390 666 0 PPM AIR35S? 11? 16 42 66 0*6 390 ?*3 0 PP$4 AIR3562 134 17 33 53 001 2*4 6*8 0 PP" AIR3564 116 19 27 so oes 2*5 6*9 0 PP" AIR3569 143 22 29 ?4 I'D 2*7 794 0 PPM AIR3%73 IDS 14 29 so 0.7 3*1 ?07 0 PP" AIR35?8 Its; lei 53 97 0*4 296 7.3 100 PP04 DIR3?00 109 in so ?2 n.3 3*2 609 100 PP" nIA3702 123 is 117 110 0*4 3ol 6*9 100 PPM DIR3?06 123 14 123 119 ols 3*3 ?o6 100 PPM nlR3TO9 107 14 40 Sh 0*3 3*2 6*6 100 PPM DIA3713 112 13 39 67 093 3*1 7*2 too PPM DIR3?18 112 16 41 57 0.3 3o? ?.S 100 PPM DIR3?25 132 1? 42 TO 0*3 305 7*2 too PP" DIR3?30 132 is 48 9? Oo4 3*S ?*6 100 PPM 0103739 84 13 62 IS4 nos 3*4 Tel 100 PPM OIP3741 116 17 TO 133 004 3*3 709 100 PPM OIR3746 119 is 41 TO 0.5 3*3 701 too PPM OIR3?52 so 19 so 107 oo3 3,7 669 100 PPM DIR3?SS 94 14 41 ?9 0*2 2*6 TOS 100 PPM DIR3758 120 1? itis 1?2. 004 3-4 699 100 PPM DIR3160 119 14 49 74 003 3.1 6*3 lie 74 39 ss 61 66 3? 97 29 109 &a T? so 86 ?? too 140 169 82 ?? 109 94 70 %I 161 62 ?b 113 160 Al 00 TABLE 14 TWO YEAR ORAL (I)ILT) TOXICITY-ONCOOENICITY STUDY OF FLUOROCARRON FM-3924 IN 04ALE MATS INDIVIDUAL PLASMA CHEMISTRY VALUES ------------------------------------------------------------MONTH=24 ------------------------------- I)OSE ANIMAL GLII RUN ALT AST TRILI ALR IPPOT ALKPHOS 30 PPM FIR3761 103 1c; 22 30 PPM CIP3763 140 19 31 30 PPM EIR3?67 13S th 33 ss o.2 2*4 bol S9 004 2*6 6.9 66 oes 2.9 6*S 30 PPM EIR3169 116 13 2? 30 PPM EIR3773 139 32 23 30 PPM FIR37?6 93 11 20 68 004 3oO 6*9 43 0*6 2.0 6.3 52 004 2*6 Too 30 PPM EIR37?9 112 in 21 ss o.2 3*1 6*3 30 PP$d EIR3?61 74 16 29 30 PPM FIR3?A6 ISR 17 2s 30 PPM FIR3?98 137 is 24 3f) PP" FIR3791 160 is 26 31) PP" FIR3794 109 Is 21 74 0*4 299 7.4 S9 0.3 393 6OR Sf$ 0.2 2.? 601 sy 0*3 3*3 6.S 44 a.2 3.0 6*3 30 PP" EIR3799 133 14 3? 54 0*3 209 6*? 30 PP04 EIR3RC3 91 ? S? 173 0.4 3oft ?,I 30 PP04 EIR360? 140 16 ?2 99 o.2 2.4 602 10 PPM FIP3Rll 146 13 22 41 4*4 3.0 606 10 PPM FlR3RlS 86 48 25 163 g.ti 203 5.3 10 PP$4 FIR3017 13A 10 20 61 002 2.8 S*9 10 PPM FIR3A22 13% 17 35 No 003 3*1 TOS 10 PPM FIR38?6 173 13 3fj 57 Oe3 3*1 6o6 10 PPM FIR3A29 86 13 38 107 006 3*rv b.9 In PPM FIRIA32 113 14 49 ei 0*3 3ol 6*6 IQ PPM FlP3A3? 146 16 33 10 PPM FIR3041 128 IT 20 5% Q.S 2*9 6.4 64 002 2o4 692 In PP14 FIR3R45 119 IN 24 54 002 208 6.? in PP" FIR3R48 130 is 27 IQ PPM FIR34SI 162 is 28 ST Qo4 S6 Cos 2,9 6*7 2.9 601 10 PPM FIR3"53 129 14 33 76 0*2 3-0 ?*4 10 PPM FIR3P56 69 7 34 OR Ion 3*S ?*a IQ PPM FIR30SR 139 16 29 65 093 29" 6o6 C;s 104 As F19 ?1 S4 al 51 103 %a 104 91 lc;4 PO 109 83 ITS 4? as 108 f13 1?4 75 140 so 79 92 126 20 66 00 !4 TABLE 15 TWI) YEAK (A#4AL IDILT) TUXICITY-UNCV6EhlClTY SIUL)Y UF FLUUHUCANBON FH-3YI4 MEAN BLOOD CHEMISTRY VALUES BLUCUSL (M6/UL) oLOCiO UNTA NITkUbEN (MU/UL) ALI (IU/L) fft4ALE N 04LAN S.DLV. MTAN SEDEV* MEAN S.DEV. IN HAT 04LAN MONTN 3 100 pem 30 PI-M 10 POOM 15 136.9 lb I?b.lo 14 13b.3 IS 13b.1 ($.IV - tl.uI ll.,Ob 10.1#o IIP.7 L,2.'Io 24.10 22.0 I.bi! 44.10 S.lb 2.33 22.6 2006 19*9 ao*5 4.07 3.ZY 4.?7 6.10 4U.0 43.tj 43.0 47.S MONTM b 0 PPM loo I-Pm 30 pro4 10 PI-M 15 154.6 IS 121010 Is 151.8 15 13d.l* 14.V" 13.45 lo.yo 9.be 2l.b 23.5 leo,9 i!118 3.k2 2.by ?.(j9 2.31 a3.5 a4.10 ;db.9 a2.7 17.20 2.293 6*62 14.40 69.7 72o? 52.6 6661 #*ONTM 12 0 ppm loo lip" 3u PPM 10 pep 15 134.9 15 127.9 14 12b-9 15 13D.7 IO.SI 20.2" 11.02 b.%-i Iv.6 LIO.3 lees la.v 2.1,o 1.95 2.20 2.70 34.1 bl*2 92.0 &6*8 15*17 74,68 9.41 lSo73 6b.1 87o9 6107 6405 MONIM la loo pped 30 PPIM 10 PPM 15 iki.5 is 1?1.5 15 12u.7 15 133.1 15.51 14077 12.ku 17.71) lb.1 20.3 111.6 16.1 2040 2.34 2.b7 3,23 ko.7 6bes 41.9 io3o9 11060 25.24 11*83 7.45 70ol 76.3 bb*2 bb,? MONTri 24 4 pp loo PPM 30 PO'14 10 prom Is 122.2 is lie.2 1!) IIJ-1 15 124.6 13.lb b.b*l lb.bi 14.45 17.V lb.3 21*V ltj.h 4.10 3.27 19.13 4.bo 6000 68o5 30.10 ;db.7o 10.11 6.72 31*20 8029 bl.es 6400 IV4.io 61.1 00 P 4= OS9 100 IAILLF) [)UNNEIT I UN HAW UATA. v P cc .(Ibo TwU IAILLO DUNNEIT I UN kANKLf) tiATA. FLMALE TABLE 15 TWO YEAN UNAL IUIL7) TUXICITY-UNCUbtNICITY MEAN BLOOD CMLMISIKY VALULS llbillo ALbo TPROI9 SIUDY Of FLUUMUCAiiHON FM-3924 IN ALKPO4059 COK9 CA) BITH STANDARD Tt)7AL blLIWUhIN (MG/UL) N MEAN SEDEV ALtIUMI[4 (6M/UL) MEAN S.UEV TUTAL PHOTEIN (GM/UL) MLAN S.UEV ALKALINL PhOSPhATASE IJU/Ll MEAN S.UEV CKEATINE PhOSPtiOKINASE IIU/L) MEAN S*DEV MUNTM 3 0 ppm 100 PP" 3o PPm 10 ppiq is O.b Osib !)03 0.45 is O.b 0.11 5.4 0030 14 0,6 (JOII 5.3 U@33 is 007 0129 b.2 0.44 NONTM 6 0 PP04 100 OP14 30 PPM lo pefq I o.b 0.14 i's 0.5 0.15 is u.b 0.010 is 0.6 0.?k 5.9 u.6b 6.0 0.28 5.7 0.141 5.7 D*Sl MUNTM 12 tj PPM 100 POM 30 Pom 10 Pom Is (J.($ 0.3h lb 0.50 0.17 14 0.50 0.10 15 0,6 0.21 4.3 4.5* 4.0# 4.2 0.26 0.3h 0.13 0.2b "UNTM 10 0 PP14 160 PP$4 31) PrOO4 10 Pool* 16, b.t) 0.?b 15 0.5 0.11 15 0.!) U.1?0 15 O.b* 0011 3.9 4.if* 3.ts 3.7 0.23 0037 0.22 U.13 MUNTM 24 ii PPM loo Pem 3u PP$4 1 to POO 04 00 15 0.0 0.31 is 0.34 0.14 is 0.4 (1.11 11 0.0 0.71 3.4 3.!) :S.2 3.4 0.21 0.34 0*43 O.i!V 0 tv *05* TwO TAILFF, btihi@E77 T ON O^o UATA. 01 tx *Obo TwO IAILEI) fjuiviit.1T1 1)14 i(AiiKL(iL)AIA. 7.2 0.41 702 0.29 701 0-33 701 0.1#7 b3o7 9a.4 91.0 78*3 32.?V ?v.97 t?le9l 15000 93.%t 85*3 125*3 gb*2 51.44 2So29 101923 46067 7.4 1.3 7.2 7.1 0.64 0-30 0.35 0.*7 77.d RI.1 95.1 6900 30*5b i?4*2b 25*01 52.bi Sb.5 70*4 SI.S 54.3 14.79 32*34 13*62 10@3d 763 0#52 7.3 0.46 7.3 0.29 7*2 Oo3S 76.5 96.3 91.3 7296 30.01 31.3* sb*bl 23o6b 54ob 20*02 IOS.fg 112,41 47*3 l5oG9 37,30 ?*Sli 7.9 u.2 11.3 7 . ti 0 .!)7, e.bi o.b? 0040 65.b 67.1 37.1* 41.Y* 52,10 20.46 11.83 17.46 37.3 26.3* 31&10 36.7* Y.ol 15.Sb 17o8l 3*.72 7.b 0.6(4 7.6 0.##b 7.3 0*89 705 0.91 68.7 97.9 bo,3 S6*7 33o3V 00.93 110*63 26*47 bO.4 SS&7 12beso 101*10 32*23 19004 89*91 42927 TABLE 15 TWO YEAR OWAL (OIET) T(IXICITY-ONCOOENICITY STUDY UF FLUOROCARBON FM-3924 IN FEMALE RATS INDIVIOUALPLASMACHEMISTRYVALUES ---------------------- -------------------------------------- MONTHS3 ---------------------- ------ DOSE ANIMAL GLU SUN ALT AST Tfi[Ll ALti TPROT ALKPMOS 0 PP14 N)R4s76 143 1?2 4?0 47 005 4*0 heR 120 a PP#4 MIR4578 ISO 2z IR 4Y 0.8 bel 700 61 0 PPM NIR4%02 129 20 17 55 Do@ 5.9 708 152 0 ppm N)R4SR3 141 is 19 41 oes 4.9 ?01 61 0 PPM NlP4SM4 129 19 29 66 0.5 4oR Tel qS 0 PPM NIR459Z 134 17 25 62 0*6 5-2 790 128 0 PP" NIP4610 143 21 3Z S? 007 5*9 ?08 68 0 PPM NIR461Z 14? 20 19 39 0.5 4fla 6o6 R9 0 PPM NIA4613 129 19 19 41 005 4.b9 ?00 61 0 PP" NIP4419 139 in Z2 51 100 5*3 609 6s 0 PP$f NIR4671 131 19 23 49 0 oto 4o9 Tel 67 0 PPM NIA4626 163 20 28 49 0,4 503 ?01 120 0 ppm NIR46?7 133 to 16 43 oes Sol 700 40 0 PPM NIR4633 134 22 25 32 oto Sot# S.o 70 0 PPM NIR4440 133 21 27 40 009 509 7.6 so too ppm GIR4757 130 16 20 32 0.4 505 794 103 100 PPM GIR4?64 122 ?2 Z4 42 094 see T.4 49 too PPM OIR4766 10? 20 20 4!i oes Soo 609 100 )00 PPM OIR4772 120 19 20 43 006 S*3 Too 110 100 ppo OIR4TPt3 118 25 25 47 0*4 S*2 700 135 too ppm GIR4765 12ft 23 is 3R ols S*3 ?.) 76 100 PP" OIR4790 130 16 22 44 a's SOS ?.4 98 100 ppm GIR4?91 131 20 IFI st o.S SOS 1.4 99 too PPM OIR4792 143 30 17 44 0,6 5,6 ?*4 73 100 PPM CIP4793 131 28 29 55 0.6 bo2 7*4 138 100 PPM GIR4806 11(i ?S 2Z 46 a.? So3 6*9 48 100 PP$4 QiR4RI2 13S 23 19 42 006 5.3 7*1 S2 100 PP04 QlR4Rl4 1?? 71 IR 3S oes Sol 609 91 100 PPM QlR4Al6 126 ?6 19 '30 o.? 6.2 769 ?9 100 PPM Qlp4Al9 116 26 IR 43 all So4 6*9 135 TA131,E 15 TWO YEAR ORAL 4nlfT) STUDY OF FLUOROCARRON INDIVIDUAL PLASMA TOxICITY-ONCOOENIGtTY PM-3924 IN FEMALE RATS CHEMISTRY VALUES ----------------------------------------------------------m-O-N-TH-=3 --------------------------------- DOSIE ANIMAL GLU HUN ALT 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM" 30 PP#4 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PP" 30 PPM 10 PPM In PPM 10 PPM 10 PPM 10 PP14 10 ppm le PP14 10 PPM 10 PPM 10 PPM 10 PPM 10 PP" 10 ppm 10 PPM 10 PPM PIR40?2 AlP4AZ3 RIR4A38 RIR4A33 PIR4436 RIR4A37 RIR4R42 RIR4A4S RlR4RSO RIR48r)3 RIR4R%4 RIP4496 RIP4860 RIR4Rfi4 RIP44fis SlR4A?l SIP4RTS SlR4A?9 SIR4ABO SIP4A"l SIR4RA4 SIP49AS SIR4RA6 SlA4AA9 SIR4A96 slR4p97 SIP4901 SIA4902 SIP4905 SIR4915 lip 34 is 146 3() 24 136 20 14 129 17 22 14S ii Is 132 20 21 130 204 13 123 27 23 IST 23 31 13A i?3 I" 133 2? is 131 If, 2k 139 22 17 129 22 10 IS9 26 19 163 in 17 13ti 22 lb 140 21 16 12r) 21 IR 130 1'4 37 136 2S 17 13A 27 Is lli3 24 19 133 21 24 130 21 31 134 22 19 139 ?2 lh 126 24 2? 130 23 20 129 20 19 AST THILI 36 0.11 59 0,8 36 006 39 007 36 006 42 0.6 52 0.6 52 0.1 43 0.6 3R 0.6 3" 0.4 cil nos 40 0.4 45 GOT 39 Do? 43 O*S 32 0.4 42 0.4 46 096 02 0.5 41 oos 36 oes 2 1.2 4S 0.7 Th 068 51 0*7 46 0.6 937 104 61 Day '33 Do? ALH 503 505 S.? Sao 4.? S.4 Soi! so" 5.1 Soo 502 Sol Sol 5*2 S.9 b.6 Sol S93 509 S*3 Sao S*2 6o2 5-i! SOS 4*9 502 4.1 4.7 4*6 TPROT 6.9 793 7o3 6.b 606 Too 1.1 los Tel ?*I 7*3 609 607 609 ?06 7.4 b*6 ?01 709 7*3 ?*2 Tel 8*0 TOP ?as TOO 700 6*1 606 6.3 ALKPHOS 97 79 91 46 59 76 13S 121 116 ?R 6? I?S 112 S4 109 as #in 69 S4 68 96 me S6 ob 96 S9 69 ?4 91 96 00 :,4 TABLE 15 TWO YEAR ORAL 4DIFT) TOXICITY-ONC06ENICITY STUDY OF FLIPOROCANHON FM-3924 IN FEMALE RATS INDIVIDUAL PLASMA CHEMISTRY VALUES ----------------------------------------------------------M-O-N-TH=03------------------------------- DOSE ANIMAL CPLU RUN ALT AST THILI AL" TPROT ALKPHOS 0 ppm NIP4%82 Ila 21 21 0 PP" Nip4%a4 172 22 ss a PPM NIR4%A6 159 23 80 0 PP" NIP4S90 183 22 26 0 ppm NIR459R 141 20 20 0 PPM NIP4603 161 22 32 0 PPM MIR4607 14? 23 3s 0 ppm NIR4616 ISO is 25 0 PP" NIR4619 140 is 26 0 ppm NIR4621 154 20 26 0 PP#4 NIR4622 160 In 34 0 PP04 NIR4629 130 20 33 0 PPM NlR4h3l 137 22 2s 0 PPM NIR4632 154 24 27 0 PPM NIP4639 15#1 31 30 100 PPM OIR4?59 121 2S 26 100 ppm QIR4?60 122 23 2S ion PP" OIR4764 16? 22 26 100 PP" QIP4?71 124 21 23 100 PPM OIR4?73 it" 24 25 too ppm GIR4?74 116 zo 20 too ppm OIR4776 129 29 21 100 PPM QIP47AS 119 24 24 100 PPM GlR4TP6 120 25 23 too PPM QlR4?Q4 123 23 25 100 PPM CIR4?98 121 26 22 100 PPM GlP4R03 146 21 20 100 PP" OIR4$06 119 27 27 100 PPM QIR4AI2 13S 20 22 100 PPM OIR4814 126 23 24 37 009 liti 006 103 oes 48 0.6 f#n 006 71 0.4 96 o.5 S6 0.4 57 0.6 47 0.7 79 O.S so 004 5s 0.4 30 o.? 62 0.6 ho 097 mo oes 54 003 64 oes TO Des 74 0*4 ?a 0*3 92 0.4 ?3 n.4 59 O.S as O.S 60 004 94 0*4 TO 003 70 007 Toe son 615 S*6 see 6.1 ses 5*2 600 609 5.6 4*9 5o2 6*4 6*4 bel SO? 6.1 S.9 6o6 50? 6.1 son s.fi 5.8 509 604 660 S.? 6*2 ?07 899 709 702 102 i's ?.o 609 702 Sol ?92 6*3 607 800 706 TOS ?*3 704 ?o3 ?07 6*R 702 lo2 6.9 6*9 793 Tob 164 702 709 13? 12S as 101 si 39 61 ss ST 51 108 96 90 so 59 104 99 40 91 106 6? S2 71 as 98 S3 Ito 94 4s 102 800 TABLE 15 TWO YEAR ONAL IDIET) TOXICITY-ONCOGENICITY STUDY Of FLUOROCARHON FM-3424 IN FEMALE RATS INDIVIDUAL PLASMA CHEMISTRY VALUES -------------------------------------------------------MO-N-TH-=-6- ----------------------------- DOSE ANIMAL GLU BUN ALT AST THILI ALB TPROT ALKPNOS 30 PPP4 30 PPM 30 PP" 30 PPM 30 PPM 30 PPM 30 PP" 30 PPM 30 PP04 30 PPM 30 PPM 30 PPM 30 PPM 30 PP" 30 PPM 10 PP04 RIR4$?2 PlR4R26 PIR4A2Q PIR4832 RIR4p3s RlR4A38 PIR4850 RIP4853 RlR4ps4 RIR4AS6 RlR4Rsa RIR4RbO RlR4R6? PIR4468 PIR4470 SIR4973 142 ?3 2s 140 19 26 141 19 24 IS2 22 27 152 20 23 149 266 45 lfto 23 29 154 22 23 144 21 26 14S 17 3? 160 19 114 147 20 31 14S 23 24 ibi 23 22 lbs 19 22 isi 22 22 Si! o.? b.2 ?06 44 aos sel ?08 44 005 6.s 7.8b 46 004 Son 7o2 40 o,ft 501 6.? 76 oes 6.0 7.6 ?1 o.? be? ?OZ 42 n.S S*2 790 4s oes 508 ?*3 ?a 006 S96 7.4 S* oes 565 6*8 64 nos 6*0 7.2 45 006 Son ?02 44 004 504 607 34 O.S 5.4 607 40 0.7 4*6 694 10 PPM SIR4A76 132 22 24 53 o.5 SO? ?*3 10 PPM SIR44TI 120 21 29 40 008 6ol 7.8 10 PP" SIR4AT8 129 24 32 53 006 6*0 701 10 PPM SIP4ROI 134 20 33 fil 004 506 ?o3 10 PP" SIR40HT 151 21 33 71 102 5*6 Too 10 PPM SIP4A90 1?6 2S 26 AM 006 5*4 790 10 PPM sip4nal 15S 23 79 IRI 1.0 663 901 10 pp" SIR4A9R 139 19 44 F47 oos 6*1 7*6 10 PPM SIR4QOI 136 20 33 72 0.;? sev ?so 10 PPM SIP4907 135 2% 2e) 43 0.6 5*3 666 10 PPM SIR4912 136 ?4 24 47 oes 6*6 ?06 10 PPM SIR4913 132 is 39 10 PPM SlR4QlS 141 19 19 77 004, SOS 608 53 o.5 sj,4 60? 10 PPM SIR4918 141 24 27 59 0*6 5*0 609 94 111 fin its 133 9T it? 76 70 119 82 112 77 34 100 113 ?3 111 43 64 as 123 Ito 84 98 126 S4 20 104 127 00 TAP,LE 17) TWO YEAR ONAL IOIFT)-TOXICITY-ONCOOENICITY STUDY OF FLUOROCARHON FM-3424 IN FEMALE .INDIVIDUAL PLASMA CHEMISTRY VALUES RATS ---------------------------------------------------M-ONTH212 ----------------------------- DOSE ANIMAL OLU BUN ALT AST TRILI ALB TPROT ALKPHOS 0 PP" a PP" 0 PP" 0 PPN 0 PPM 0 PP14 0 PPM 0 PPM 0 PPM 0 ppm 0 PPN 0 PP" 0 PPM 0 ppm 0 PP" too PPM 100 PPM too PP" 100 PPM 100 ppm 100 PPM 100 PPM 100 PP" 100 PP" 100 PP" 100 PP" 100 PPM 100 PPM 100 PPM 100 PPM NlR4S?H NlR4SR2 NIR4SRS NIR4%sa NIR4569 NIA4590 NIR4601 NIP4608 NIR4610 NIR4620 NIR4629 NIP4630 NIR4631 NIR4632 NIR4640 GIR4?Sl nIR4?60 QIP4761 GIR4763 GIR4?75 GIR4??9 GIR4700 OIR47A2 GlR4TS3 OIR47AS OIR4?AT OIR4?88 GIR4793 OIR4RO6 OIR4$16 146 2f& 124 In 13? 24 137 zo 132 19 136 19 143 20 131 in 127 21 146 19 136 in IS? 22 12A 20 113 Is 135 17 128 21 12S 21 123 19 133 21 117 20 128 19 its ly 123 ?1 III In 128 ?1 120 19 198 21 129 In 121 26 119 21 27 22 33 23 67 24 1#0 24 25 31 67 42 41 19 26 20 21 25 36 el 24 30 30 4b 25 39 31#1 64 37 26 414 42 bo 47 103 4f% 59 51 62 si ily 79 94 33 41 39 47 so 65 56 3H 56 54 74 so ci4 492 124 614 si 1*2 1.5 0*8 oes o.? 0.6 006 1*1 1*0 0.6 0.14 0.5 oes 1*4 o.? 0.6 O.S 004 064 0.,# 004 0*4 0.4 004 o.3 004 100 o.? 0*4 0.5 4*1 7o3 4.7 8*6 4.5 7.6 404 740 4*fj ?07 495 ?93 4.1 7*3 4.2 ?92 401 7.1 401 7.0 3.9 6.7 3*8 6o6 4e4 794 4*3 8o2 494 ?02 4.7 ?OT 406 793 SOO 6o2 4.6 706 4.7 ?.4 4.A les 5*0 ?00 jon 604 4ol be? 4.1 bee 4.2 7*4 4*b 7*3 493 7*3 402 ?05 5.0 ?*A 71 134 84 44 104 84 12? 39 72 ?1 80 S4 99 43 42 119 02 4S si 41 101 151 132 120 71 144 T3 104 141 70 TABLE 15 TWO YEAR ORAL 40[ET) toXICITY-ONCOOENICITY STUDY OF FLU(JROCAR140N.FM-3924 IN FEMALE RATS INDIVIDUAL PLASMA CHEMISTRY VALUES ---------------------------------------------m------------@-MONTHzl2 ------------------------------ DOSE ANIMAL GLU HUN ALT AST THILI ALO TPROT ALKPHOS 30 PPf4 PIR4422 120 17 20 46 004 405 609 86 30 PPM RIR4A24 13A la 23 so oes 4*6 7.4 60 30 PP" RIP4838 112 19 54 6" 006 4.s 7*7 102 30 PP" RIR4939 127 23 30 6" 0.4 4*3 6*9 104 30 PP" RIR4R4O 13S is 38 70 o.5 4.5 7.6 136 30 ppm RIR4R42 132 20 46 a? O.S 4.5 7*2 145 30 PP" RlR4R49 113 20 34 62 O.S fb*4 705 121 30 PPN RIP4949 131 IT 2A 40 0.4 4.1 699 49 30 PPM RIR4RSO 151 18 35 ?3 096 #0.2 7.4 110 30 PP" RIR4Rs2 124 20 26 ss o.? 4.3 705 Ro 30 PPM RlR4ASS 120 17 34 Ab 004 4.4 ?03 92 30 PPM RIR4RST 132 20 20 42 004 4*3 ?*1 91 30 PPM RIP4862 131 19 33 74 004 404 1.4 44 30 PPM PIR4RhO 122 13 22 47 093 44.4 705 13 30 PPM RIR4R?O 14(1 18 24 so 0.5 4*4 608 131 10 ppm SIR4A?4 139 17 62 ob o.? 4*1 ?so 83 10 PPM SIR4095 140 24 a5 57 0.5 4*4 ?.b 91 10 PPM slR4R86 114 21 24 43 009 4*0 701 Sq 10 PPM SIR4A94 132 20 2h t#14 102 4*5 708 ?a I@ PPM SIP4897 141 17 3? 5#0 004 400 6*7 46 10 PPM SIR4899 137 21 31 4" Cos 4.3 T.z 63 10 PPM SIP4902 142 17 26 S2 006 4.2 ?.o 66 10 PP" SIA4903 121 20 ?8 12S 004 4.5 To& ?6 10 PPM SIR4907 140 17 36 62 0.5 4.1 be? AT in PP" SIP4909 131 15 37 64? 006 dt.2 1.1 47 le PPM SIR4912 133 23 28 63 oes 4.b Y*3 49 10 PPM slp4ql6 14% 16 50 78 ols 4.3 loo 102 10 PPM SIR4QIT 143 20 24 42 0.7 462 793 83 10 PPM SIR4910 138 19 42 ?1 006 404 7*3 123 10 PPM SIP4920 139 16 26 67 396 606 34 TABLE 15 TWO YEAR OHAL IDIET) TOXICITY-ONCO(JENICITY STUNY OF FLUOROCARBON FM-34?4 IN FEMALE RATS INDIVIDUAL PLASMA CHEMISTRY VALUES ----------------------------------------------------------M-ON-T-H=IB ------------------------------ DOSE ANIMAL GLU RUN ALT AST THILI ALB IPROT ALKPMOS 0 ppm 0 PPM 0 PPM NIR4501 NIR4%R3 NIR45eb 12" ?? 120 17 98 19 37 50 oo3 3-3 694 40 fo4 0.0 3.9 6*4 59 93 0.3 3*1 ?*a a PPM 0 PP" NIP4592 NIR459S 10? 23 116 Is 35 53 Oeb 402 8.4 71 132 0,4 4*0 806 0 PPM NlR4S98 123 1? 9>5 79 0.13 400 Too 0 PP04 NIR4S99 133 16 69 106 o.S 400 707 0 PPM NIP4602 103 21 43 so 00" 400 8*2 0 PPM NIR4604 )so 14 30 44 oes 3*8 T*4 0 PP" NIP4606 126 In 5" 79 o.7 3*0 ?*a 0 ppm 0 PPM NIR4609 "1"4611 Ila is 143 19 40 6s 1.0 402 806 40 49 0*6 4*0 ?*S 0 PPM NIP4612 13A is 42 49 le2 3.0 709 0 PPM NIP4677 116 16 42 fiti 0.6 3*7 708 0 PPM NIR4639 141 is 54 6!i 0.9 490 R*3 100 PPM QIR4?62 110 17 in? IRS 0*7 3.3 8*4 100 PPM oIR4765 136 22 41 6s 0.5 4o3 ago 100 PPM OIR41?2 IIR 21 46 ?3 0*6 4.4 802 100 PPM QIR4?76 136 19 23 49 0.5 4.? so? 100 PPM 100 PPM OIR4?78 QIP4?99 163 is 124 21 it) 57 006 4.2 Sol 34 so 006 406 900 100 PPM GIR4T94 139 21 28 40 065 4*4 sel 100 PPM OIR4ROl 139 21 Lis ag oos 4ol ?06 100 PPM OIR4RO3 138 PO 4t) 67 O.S 4eS see 100 ppm OIR4007 IOR 11 3? 62 093 3o7 6.7 loo PPI# alp4pos 130 22 H2 136 0.5 403 sea 100 PPM OIR4611 116 i!O 2" so 0.4 4*1 8*3 100 PPM QIP4AI3 123 23 119 112 0*3 4.0 ?09 100 PPM OIR4014 110 23 28 4" oes 4*4 8*8 100 PPM OIR4Rl? 123 22 so 63 o.5 3.8 lob as 51 152 91 63 40 S3 ss 62 me 56 17 60 27 79 fis 99 93 3S 4? ST 54 66 63 72 S4 38 R? so 96 TABLE 15 TwO YEAR ONAL@'iOIET)"FOXICITY-ONCOOENIOITY STUDY OF FLUOROCARHON FM-3924 IN FEMALE INDIVIDUAL PLASKACOEMISTRY VALUES RATS ---------------------------------------------------m-o-i-i-v-m-=-l--o------------------------------ DOSE 30 PPM 30 PP" 30 PPM 30 PPM 30 PPM 30 PP" 30 PPM 30 PPM 30 PP" 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 10 PP" 10 PPM 10 ppm 10 ppm 10 ppm 10 PPM 10 PPM 10 ppm 10 PPM 10 PPM la PPM 10 PPM le PPM 10 pp" 10 PPM ANIMAL PIR4A24 RIP402S RIP4832 RIR4A36 RIR4A39 RIP4444 RlR4A4S 4IR4A46 RlR4A4? plR4R49 RIP4955 RIR4861 RIR4Rh2 RlR4R63 RIR4864 SIR4A72 SIP4873 SlR4A?6 SIP4470 SIR49RO SIR4R92 SIP4A43 SIR4QO3 SIR4904 SIR4907 SIR4909 SIR4910 SIR491S SIR4QI6 SIP4919 GLU BUN 132 23 112 21 14A 16 13S 16 13A 20 120 lb 129 16 103 1? 131 is 124 Is 119 is 132 20 12S IN 149 23 134 20 109 Is Ion 20 146 20 132 is 136 17 149 in 120 11 120 21 130 17 1?? 19 120 1? 116 14 li? 16 14'i 11 14-1 14 ALT AST T"ILI ALN YPROT ALKPHOS 42 42 0*" 3-9 8*4 21 45 7? o.5 3*9 901 33 51 6i! 0*? 3-9 9.1 30 53 75 0*3 3.1 goo 21 27 55 0.4 3.? 705 60 44 bs 00'4 460 8.7 44 39 95 004 4.1 803 S2 28 72 ols 309 802 31 43 71 006 3.4 806 so 29 41 003 396 7.8 26 3? 513 0.41 3.6 Too 41 44 57 o.5 3.3 7*0 34 39 ill) 0.3 3.h (fol 34 74 105 100 3.y 996 so 39 70 o.S 3.1 709 30 37 f)S O.to 391 709 47 2ti Sh 0.41 3-6 7.7 61) 29 47 005 3-8 le6 54 26 48 o.S 3*0 1*0 25 34 49 0.5 3e" goo 2R 48 78 o.5 3-7 862 66 33 ?4 0.4 3*b 1.4 26 40 fil o.? 3.7 8*2 39 2" 55 oes 3o4 ?96 ?4 36 is 0*6 3.9 sez 62 27 54 004 305 7.4 2s Pti 53 oes 3.9 8.1 18 '30 "1 0.6 3*7 0.8 34 29 4H 0.2 3.4 6.fi 33 36 51 oes 3.7 ?*4 3? TABLE TWO YEAR ONAL (DIET) STUDY OF FLUOROCAROON INDIVIDUAL PLASMA TOXICITY-ONCOOENICITY FM-3924 IN FEMALE PATS CHEMISTRY VALUES -----------------------------------------------------------MO-NtH=24 ---------------------------- DOSE ANIMAL GLU HUN ALT AST 7141LI ALB TPROT ALKPNOS 0 PP" NIR4%R3 135 17 36 52 1.0 3*3 8.1 49 0 PP" NIR4SA6 121 la 152 an 0*3 3.4 7.3 149 0 PPM NIR4591 IIA 20 32 sa 16Z 3.S ?08 127 0 ppm NIR4%9S 123 1? 66 Ise 005 3o6 8.5 S3 0 ppm NIP4598 140 16 37 52 094 3*4 792 38 0 PP" NIP4603 13R 26 34 56 0.4 3o4 702 3s 0 PP04 NIR4606 120 17 36 52 007 3*3 7*9 78 0 PPM NIA4611 148 21 42 al nos 3-? 6*S ?0 0 ppm NIR4614 iis IT 37 42 0*6 3*1 ?06 76 0 ppm NIR4616 IIR 16 4Z 73 0.4 3o3 TOS 46 0 PPM NIR46?6 112 10 Z7 sz o.2 3.7 8*6 39 0 ppm NIR4628 107 15 36 4H 094 3o2 705 39 0 PPM NIR4634 9? 26 42 9A 002 i!09 601 a? 0 PP" N144636 130 is 29 42 0.6 3*4 I's 61 0 PP" NIP4638 111 17 S2 64 161 3oS ti.4 04 100 PPM OIR4?S9 109 16 41 ?b 0.2 3o3 6*6 94 100 PP" GIR4?tj4 97 13 41 57 oo2 3o2 ?.to 117 100 PP" QIR4?67 99 Ili 30 52 o.3 3-b 7.8 71 100 PP" GIR4?69 120 1,* 30 44 0.3 3*2 1.3 42 100 PPM GIP4?73 121 is S2 TV 004 3oS 7.4 83 100 PP" oIR4778 120 12 3H 60 002 3*4 70" be 100 PPM OIR4?94 110 Is 37 46 0*4 4o? 802 73 100 PPM GlR47q6 123 19 .32 4H 0*2 3.6 ?03 so 100 PP14 olR4AOO 102 20 se 84 003 3.8 "&1 IRR 100 PP" GIR4003 114 ih 40 sto 003 4.0 801 82 100 PP" GIP4AO9 114 14# 45 71 0.6 3ei! hog 97 100 PPM GIP4All lip Is 33 39 0*3 396 796 S2 100 PP" OIR4Rl4 III ?4 35 42 o.S 393 ?09 112 100 PPM QlP4RlT lin 1? 41 73 0,2 209 Sol 146 100 PPM alR4R19 107 12 60 iis 0.6 3*2 7*4 161 04D TABLE 15 Two YEAR ORAL 4i)IET) TOitICITY-ONCOGENICITY STUDY OP FLUOROCARNON FM-3924 IN FEMALE RATS INDIVIDUAL PLASMA CHEMISTRY VALUES ------------------------------------------------------M-O-N-Tr-i=24 ---------------------------- DOSF 30 PP" 30 PP" 30 PPM 30 PPN 30 PP" 30 PP" 30 PPN 30 PP04 30 PPN 30 PPM 30 PPM 30 PPM 30 PPM 30 PPM 30 PP$4 10 ppm 10 PPM 10 PPM 10 PPM 10 PPM 10 PPM 10 ppm 10 PPM 10 PPP4 10 PPM 10 PPM 10 PPM 10 PPM 10 PPM 10 PPM ANI"AL RIR48?2 PIR4R?6 RIR4A2? RIR4832 RIP4834 RlP4R36 RlR4R39 HIR4A44 PIP&84? RIP4951 RlR4AS4 PIP4@S" RlP4PS9 RIR48h4 RIA4069 SlP4AT2 SIR4R?3 slR4RTb SlP4RAl SIR4802 SIR4RO4 SIR4RAS SIR48Q2 SIP4994 SIP4R97 SIR4903 SIR4914 SIR491h SIA4910 SIP4919 GLU RUN )Ili 27 103 14 121 IFI 127 is 138 lb 119 iki Its Is 98 is ins is S? 90 113 19 121 1? 175 14 117 Is III 14 112 19 1-46 PO 1?9 17 141 1? 139 21 116 26 132 ?0 141 lh 138 70 110 9 93 10 126 16 133 16 IIA Is 109 10 ALT 25 29 42 30 22 33 25 31 2S 146 34 26 20 21 20 25 26 21 30 ZY 17 75 26 40 14 14 27 31 ltt 42 AST THILI 22 Sh foh 646 49 62 ss TO 120 1960 109 6" Sh 105 6? sy 51 4? 50 76 53 1 52 63 60 49 S6 4FI 66 13i! 57 0.2 o.3 0.4 oes 066 0.4 004 003 cob o.S 013 001# 0*2 oes Doi oes 006 003 0*6 107 o2 I*S o.3 2*8 004 007 Ole$ 0.3 003 0.6 ALO 3.4 3.2 3.4 3.5 3*3 3oO 3*6 304 2*5 2.2 3.4 3*9 Z.9 3.4 3.4 3.5 364 392 3.6 3-3 2o8 3*06 3.4 3.R 3*6 309 3o4 2.9 3.3 3*6 TPROT ft.3 ?06 ?08 802 ?e3 600 709 894 be? SOS "as Ron r.b 7.5 6004 707 ?as 694 ?00 8*1 690 698 701 9.1# ?*2 994 7o3 6*2 701 7.4 ALKPMOS 39 as 42 S9 63 26 as 64 81 Sil ?a ?I 4s 30 43 100 A2 se 34 ?1 38 fie 98 65 21 ? ?0 52 42 44 to @n Table 16 Two Year Oral (Diet) Toxicity-oncogenicity Study of Fluorocarbon FM-3924 in 0281CROO12 Urinalysis Values Specific Dose Group Gravity pit 3 Mo. Male Control 100 PPM 30 PPM 10 PPM 1.025-1.062 7-9 1.033-1.060 6-7 1.012-1.058 6-7 1.027-1.056 7-8 3 Mo. Female Control 1.011-1.052 7-8 100 PPM 1.009-1.064 7-8 30 PPM 1.028-1.064 7-8 10 PPM 1.023-1.070 6-8 6 Mo. Male Control 100 PPM 30 PPM 10 PPM 1.021-1.066 6-8 1.028-1.068 6-6 1.030-1.058 6-8 1.030-1.064 6-8 6 No. Female Control 1.028-1.072 6-7 100 PPM 30 PPt4 1.016-1.053 6-8 1.022-1.046 6-8 10 PPM 1.020-1.058 6-8 Albumin N-Tr N-2+ N-I+ N-N N-I+ N-Tr N-Tr N-I+ N-3+ N-2+ N-4+ N-3+ N-3+ N-N N-Tr N-I+ Bilirubin Glucose N-N N-N N-H N-N N-N N-N N-N N-N N-N N-N N-N N-N N-N N-H N-M N-N N-N N-N N-N N-N N-N N-N N-N N-N M-N N-N N-H N-N N-N N-N N-N N-N Occu Blooc N-4+ N-2+ N-N N-I+ N-N N-N N-N N-N N-3+ N-3+ N-N N-N N-I+ N-N N-N M-N Code: N - negative Tr - trace 1+ - slight 2+ - slight to moderate 3+ - moderate to marked 4+ - marked Table 16 (continued) Two Year oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 In R 0281CROO12 Urinalysis Values Dose Group 12 Mo. Male Control 100 PPM 30 PPM 10 PPM 12 Mo. Female Control 100 PPM 30 PPM 10 PPM 18 Mo. Male Control 100 PPM 30 PPM 10 PPM 18 Mo. Female Control 100 PPM 30 PPM 10 PPM Specific Gravity 1.040-1.093 1.020-1.056 1.034-1.060 1.026-1.058 1.023-1.070 1.017-1.062 1.020-1.044 1.015-1.071 1.016-1.064 1.044-1.088 1.030-1.090 1.008-1.075 1.016-1.058 1.017-1.056 1.018-1.058 1.016-1.056 Code: N - negative Tr - trace Occult pH Albumin Billrubin Glucose Blood 7.0-8.5 N-4+ N-N 7.0-7.5 N-2+ N-N 7.0-8.0 N-2+ N-N 7.0-8.0 N-2+ N-N N-N N-3+ N-N N-N N-N N-Tr N-N N-3+ 6.5-7.5 N-3+ N-N 6.5-8.0 N-4+ N-M 7.0-8.5 N-4+ N-N 6.5-8.0 N-4+ H-H N-N N-N N-N N-N N-N M-N N-N N-2+ 6.5-8.0 N-3+ N-N 6.5-7.5 N-4+ N-N 6.5-8.0 N-4+ N-N 6.5-8.0 N-4+ N-M N-N N-2+ N-N N-Tr N-N N-I+ N-N N-2+ 7.0-7.5 N-3+ N-N 6.5-8.5 N-I+ N-N 6.0-8.0 ti-4+ N-N 6.0-8.0 N-3+ N-N N-H N-N N-M H-Tr N-Tr N-N N-N N-Tr 1+ - slight 2+ - slight to moderate 3+ - moderate to marked 4+ - marked Dose Group TABLE 16 (concluded) Two Year Oral (Diet) Toxicity-OncogenicitSytudy of FluorocarbonFN-392 0281CROO12 UrinalysisValues Specific Gravity pH Albumin Bilirubin Glucos 24 Mo. Male Control 1.018-1.054 6.5-8.5 N-4+ N-N N-N 100 PPM 1.017-1.071 6.0-8.0 N-4+ N-N N-N 30 PPM 1.007-1.096 6.0-7.5 N-4+ N-Tr N-N 10 PPM 1.019-1.080 6.0-8.5 N-4+ N-N N-N 24 Mo. Female Control 1.012-1.034 7.0-8.5 N-2+ N-N N-N 100 PPM 1.011-1.033 6.5-8.0 N-2+ N-N N-N 30 PPM 1.008-1.034 5.0-8.0 N-4+ N-N N-N 10 PPM 1.010-1.037 6.5-8.0 N-3+ N-N N-N Code: N negative Tr trace 1+ - slight 2+ - slight to moderate 3+ - moderate to marke 4+ - marked 4D ?0 TABL E 17 TWO YEAR ORAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FM-3924 ABSOLUTE AND RELATIVE MEAN ORGAN WEIGHTS ONE YEAR INTERIM ABSOLUTE ORGAN WEIGHT (GRAMS) 0 PPM 100 PPM ------------ ------------ MALE N m IS N = IS ORGAN WT WT SD ------------------------------------------------ BODY 62S.S+-6S.905 SSS.3+-40.619* LIVER HEART 19.IS+- 3.212 1.629+- O.IS7 26.11+- 2.891* 1.449+- 0.1380 SPLEEN KIDNEYS ADRENALS TESTES 0.694#- 0.144 3.054+- 0.507 .0679+- 0.013 3.553+- 0.419 0.734+- 0.112* 3.868+- 0.295 .0532+- 0.006* 3.566+- 0.409 BRAIN 2.113+- 0.111 2.049+- 0.059 PITUITARY .0205+- 0.006 .0105+- 0.002* FEMALE N = IS N = IS ORGAN WT SD WT so ------------------------------------------------ BODY LIVER HEART SPLEEN KIDNEYS AORENAL.S UTERUS BRAIN PITUITARY 401.1+-77.172 12.28+- 1.904 1.117+- 0.134 0.663+- 0.'123 2.533+- 0.'383 .0761+- 0.012 0.775+- 0.247 1.963+- 0.128 .0227+- 0.006 335.7+-57.72IN 17.72+- 2.4160 0.990+- O.ti3o 0.535+- 0.103N 2.715+- 0.275 .0624+- 0.006 0.661+- 0.185 1.954+- 0.093 .0215+- 0.007 n : P <= .05, TWO TAILED OUNNETT T ON RAW DATA. I : P <= .05. TWO TAILED DUNNETT T ON RANKED DATA. TABLE 17 TWO YEAR ORAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON FM-3924 IN ABSOLUTE AND RELATIVE MEA N ORGAN WEIGHTS ONE YEAR INTERI' M ORGAN WEIGHTIBODY WEIGHT (%) 0 PPM 100 PPM ------------------------------ MALE N = IS N c 15 -----OR-GA-N---------%-------so--------% -----s-o----------- LIVER HEART SPLEEN KIDNEYS ABRENALS TESTES BRAIN PITUITARY 3.053+-0.318 0.262+-0.021 0.144+-0.02S 0.617+-0.057 0.011+-0.002 0.570+-0.057 0.340+-0.026 0.003+-0.00,1 4.7324-0.6640 0.2614-0.022 0.132+-0.019 0.702+-0.0570 0.010+-0.001 0.6464-0.064* 0.371+-0.032N 0.002+-0.000* FEMALE N m 15 N = 15 -----OR-GA-N---------%-------SD--------% -----s-o----------- LIVER HEART SPLEEN KIDNEYS AORENALS UTERUS BRAIN PITUITARY 3.090+-0.293 0.284+-0.038 0.168+-0.031 0.642+-0.091 0.020t-0.005 0.201+-0.077 0.507+-0.105 0.006+-0.002 5.3434-0.652N 0.299+-0.032 0.160+-0.026 0.623+-0.107* 0.02S+-0.006N 0.265+-0.073* 0.5984-0.1000 0.006+-0.002 P <= .05, TWO TAILED DONNETT I ON RAW DATA. I P (z .05. IWO TAILED DUNNETT I ON RANKED DATA. TABLE 1.7 TWO YEAR ORAL (DIET) TOXICITY-ONCOGENICITY STUDY OF FLUOROCARBON ABSOLUTE AND RELATIVE MEAN ORGAN WEIGHTS ONE YEAR INTERIM FM-3924 ORGAN WEIGHT/BRAIN WEIGHT (RATIO 0 PPM 100 PPM --------------- --------------- MALE N = 15 N = 15 ----O-R-GA-N-------R-AT-I-O-----S-D-----R-A-TI-O-----SD------------ LIVER HEART 9.049+-1.321 0.772+-0.071 12.75+-1.452 0.707+-0.067: SPLEEN KIDNEYS ADRENALS TESTES PITUITARY 0.424+-0.070 1.821+-0.192 0.032+-0.006 1.678+-0.150 0.010+-0.003 0.359+-0.056* 1.899+-0.155 0.026+-0.004* 1.743+-0.213 0.005+-O.Ooi* FEMALE N = 15 N = 15 -----OR-GA-N-------R-A-TI-O------SD------R-AT-I-O----S-D------------ LIVER HEART SPLEEN KIDNEYS ADRENALS UTERUS PITUITARY 6.273+-1.001 0.571+-0.073 0.337+-0.056 1.294+-0.197 0.039+-0.006 0.397+-0.130 0.012+-0.004 9.074+-1.208* 0.507*-0.055* 0.273+-0.049* 1.309+-0.122 0.042+-0.004 0.439+-0.083 0.011+-0.004 P <= .05, TWO TAILED DUNNETT T ON RAW DATA. I P <= .05. TWO TAILED DUNNETT T ON RANKED DATA. TABLE .17 TWO YtiAN 4)HAI 41)11;fl tflxiCITY-ONCO(s@NICITY Sti)DY IJF FLI)0144)CA1414flNF#4-3974 IN 04AI,E MATS ON[ YLAH INIEPI64 INIIIVII)UAL ()PCAN %ElrvhtS DOSE ANIMAL RODY LIVFR HEART SPLFFN 0 PPM 0 PP" 0 PP$4 0 PPd 0 ppf4 0 PPM 0 PPIA a ppm 0 PP&4 a ppm 0 PPM 0 PP" 0 ppm 0 PP" 0 PPM 100 PP04 100 PP" 100 ppm too PPM too PPM 100 PP$4 Ina PPM Ina ppm 100 ppaq 100 PP" ion PPM too PP#4 too PP" Ion pp" 100 PPM AIP-3gil6 AIR-3517 AIR-3S?O AIP-3S2? AIR-3527 AIR-3ci3S AIR-3S43 AIR-3%46 AIR-35SO AIR-3551 Alp-3,;giq Alp-3r)hn AIR-35?0 AIR-3si?S AIR-3SAn PIR-3696 RIP-36qq BIR-3711 RIR-3714 RIP-3715 RIP-3724 PIR-3721 HIP-1727 RIP-3727 PIR-3732 RIP-3T33 HIR-3?36 RIP-373? RIP-3?4? HIP-3146 120 6SI 6'ici 627 634 S94 747 656 566 494 627 6"0 ei7s ssi civa r,66 521 541 sis ft2s sio Sys 590 610 467 561 S43 r3s? 535 SOS 23,RR 21.?4 201ar 16.IR 16071 18.12 24.Qh 17*61 15.19 13.96 19.%] 27.11 16.55 19.RS 19.77 79.14 Z6.43 2?o%l 3Dof4O ZIOMY 23ogg 23.24 2S.17 260nfi ?;D.sl 25.S3 ?9.4h 30o?? 26.3h 23olo 1.7#ih les6s 10719 1.6?S lost? I.bLi4 lo7t13 2oold 1.41fp 1.361 1*53h 1*(124 1.5?6 1.636 10556 1051h 1* 31 to 10431 1.691 1.414H 1.3hil l.ft2s 1.4,?g 1.510 lo:jo? loS49 1.2t.4 1*351) 1*3ho lobl2 1.079 O.H74 (16777 0.714 n.65" o,fl4c; O.t#04 0090'5 Oo?04 0.151 no"?? 1.1091 n.%;ql 1.113 lol)?A 0. 74c; a.h3i 0.??9 0078$7 O.ti4s 0.579; 0.74'4 0.704 0 0 ?1 C; a.hic; 0050? 0."19 a.ini O.i4?;p 0.093 NOTES: BODY WEIGHTS AND ORGAN WEIGHTS ARE IN G. a INDICATES ADRENAL AND PIIUITARY WEIGHTS IN MG. KinNFYS 3.970 4*114'1 4.3c%? #60241 3.1ciis 3.474 4*36% 3.9sp 3.6%6 24t.9;7 3.C;404 -#.614 3.S?ci 3.781 4.170 3.444 j.h&4 3.m%is .4.9146 3.qc;4 3.473 4.IF44 4.-tl3 J.Afq J*&RR 3*46Y 3.kh83 39941 JOA?? 4.394 AtiIENALSa 94 66 6%7 67 S7 "? 54 77 41 S9 ?to 64 h4 f#7 16 4? 4tt 4y Li1 hi 5(1 ci2 Cih gi 1 so Cti ii 40 gii ss Tfc;TF-, 3.7?7 4.147 3. Yf%I 3.1(04 3.316 3.Plo 1.704 3.40*0 3.411 ?.CIHI 3.331 I.Myn 3.%03 P. C444 @3.411% 3. 1rgi I.tllts .1.??n 30144 1*7h? 3.4110 3041% 4 .60@ 1 3,4n? .1.04c; 104ft4 I.rmil 3.7?1 loolh TABBE 17 TWO YEAR 014AL 41,IET)lf)XICITY-Or4CO(iFNICITY STUDY 01;Fl-tit)RtICARF1M4-O.N19,04IN FF?44LFPAT% ONE YEAR INT[1410I4NI)IVIIIIIOARLCIANwt-16#iTS I)OSE AN114AL RODY LIVER HFART SPLEFN eqII)Nyfs AI)W@NALS! (ITFOII4; 0 PP14 0 PPN 0 PP" 0 PP04 0 PP#4 0 PP" 0 pp" a PP#4 0 PP04 0 PP" 0 PP04 0 ppiq 0 PP04 0 PP#4 a PP14 100 PP" 100 ppm Joe PPM 100 ppm 100 PP" 100 PP" Joe PP04 is@ PP04 loo PPM 100 PPN 100 PPN Joe ppiq 100 pp" 100 PP" 100 PP04 NIP-4S?@ NIP-4502 NIP-4sms "IP-4564 NIA-4SR9 NIR-4c#98 NIR-4601 mlq-4606 NIP-4610 HIP-4624 NIP-46?9 NIR-4630 NIA-4611 NIR-4612 NIP-464n OIP-47%1 010-4?64 OIR-4161 OIR-4Y63 OIR-4775 CIP-47?9 OIR-4184 OIR-4?82 014-4701 OIR-4?AS OIP-4181 OIR-4?AA 4) 1 P-4 ?9 3 OIR-4006 OIP-4416 S40 ]as 3S3 386 37'i 313 470 429 34S 320 fb0 1 466 248 S.11 34S 37? Ins 324 294 368 3is 759 372 2SI 400 401 279 43) ?I? 3100 IS.34 12.26 12090 11.99 13.19 lS9S2 13039 13sea 11.31 11045 11*33 l3*A3 7937 14,70 I IOf&9 19034 11.91 16*93 IROP" 20.FI4 16.6,? 14*36 17.14 1?931 l?o3S 19.Sf# 16.DS 19.ftm IF1.14 21.9ti 1*390 1.1"s 1.035 loll? 1009S 10037 loib4 1*021 00902 19176 19004 1.2ho Resin 1*128 1.?3" 1.140 069hy 0.991 0.91#2 1.13A 0.941 11.153 0.9?6 fo.is?!) 1.001 1.039 41.9#)u 10049 Q*N"CI 1*134 0.?Sl 0*41" (106?6 o.h79 0.651 OOS?L notif$Ft 00648 00681 067"9 O.hftl 0.17% 00414 0.171 ooril a.ft?l 004act 0.407 O.Stop 004%7 0.1#67 0.281 0 .scig@ 4.8#67 D.ftstt o.fi?P O.floq 0.64A 0.477 30279 2.4as 2*??3 2.%34; 3.lnoi 20304 3011@i 2o3Sf# E*439i 2*470 20 1 if$ ?.A IA I.R44 2.670 2.661p 301113 3.Dli% 2.AA6 2*??? ?. 6 In i-l1e34 e.9-10 e.6711 2.A43 P.?04 No "I l.Irl 144 f).oi46 6r) NO 6;@ n giq 0.04110 4ep 0.1411 rh 0.7041 AS 0,407 R4 Ql ?" "#I lol?S nonin a.r,.Is VT (I.I lgi To 0.73" "4 l.nip 76 n.744 is n.Alk NOTES: BODY WEIGHTS AND ORGAN WEIGHTS ARE IN G. C:) a INDICATES ADRENAL AND PITUITARY WEIGHTS IN MG. TABLE 18 TWO YEAR ORAL IDIET) TOXICITY-ONCOOENICITY STUDY OF FL"OROCARSON ARSOLUTE AND RELATIVE MCAN ORGAN WflOt4T% FM-3924 AHSOLUTE OROAN WFIGHT (GRAMS) HALF 0 PPM N 106 Ppm ----------- N r. 19; 30 PPM N 15 10 p db N OROAN WT so WT ------------------------------4------- so WT SD WT -----------------m ---M ------- Sony LIVFK 14EAPT SPLFEN KIDNEYS ADRFNALS TESTES ORAIN 666.7#-99.761 10*IS*- 3oOr4 1.720#- O.2ab 1021?*- 00339 4.40S#- O.?4b .0801*- 00018 3.478*m 0.70e 2*lob*- 0*133 5oao2#-8oe935* 22blO#- 3i36e* 1.69s*- 0.212 OeTS4*- 0*1420 40003#- 0.443 *08054- OEOISA 39544#- 0#530 2oO75*- 0.093 648*7*-S?*484 2Oo69#- 2o2*6 lb793*- 9ol85 009n$*- 0*126* 46519*- 0*372 .1026*- foo4o 364014- 0*616 2*1410- 00126 6510 16*3 1.?9 1.02 4.o34 0498 3*71 ?010 FEMALE N a 15 N a IS N a 19 N ORGAN WT Si) 11T so WT S() WT -----------------------------------------@--.& -------------------------- "Of)Y LIVFN HEART 512.S*-B2oS8bo 15.11*- 9.7b2 1,366*- 4.199 413*4*-R3il58* 20618*- S*013* I.a4l*- 0.19S 4SI*9#-690s?? 160%9*- 341?0 16229#w 00188 S04% 1700 1*37 SPLEEN KIDNEYS ADREN&LS UTERUS BRAIN 0.7q?*3.1?9*01030#00814*?*03*4- 0.140 0.201 too4bp 00290 4*102 04731#3*193#ollRS#1*60261.997*- 00178 Oo4O6 0*036 Do328 0.119 Ob747#39143#- 1193#o&836*16936*- 10208 9o337 fe043 092?1 4*179 047? 3*09 143 0046 1096 * t P en .059 TWO TAILFN DK)NNETT a iP *OS* TWO TAILED OUNNETT A : N 13 ANIMALS. 8 : N 14 ANIMALS, T ON RAW DATA. T ON PANKEN DATA'* TABLE 18 TWO YEAR ORAL (DIETI TOXICITV-ONCOGENICTTY STUDY OF FLOOMOCARRON ABSOLUTE AND RELATIVE MEAN OMGAN WCIOHTS FM-39?4 I ORGAN WEIGWT/sony WEIGMT (%) 0 PPM --------------- 101 ppm -------- 30 PPM 10 PPM MALE N c 15 N = 15 N &* 15 N OROAN % SD s SD so -------------------0------------------------------------O--Z-.-O --------- LHIEVAFR.TR SPLEEN KIDNEYS ADRENALS TESTES MRAIN 2.733+-04339 0.261+-06031 0010?4-00059 0.666*-ObIOI oeol2*-o*oo3 0.536*-Ool44 0*322*-0%049 3*836*-O*S9S* 0*297+-0.058 0*130*-0*0250 Oof?4*-Oel660 0-614+-0.003A oo6la+-o.ll4 0*364+-OeO6O 36el6+wO63444 ook86*-Oio42 ObIS4+-Oi#34 06706+wOiO9S 0*016*-OoOoe DoS2$+vO*092 09339+-OiO4o 2.812* 0.2?8* 0.156+ 00677+ 00015* 0.579* 0.337* FEMALE N a 15 N a IS ORGAN -------------- LIVER HEfiRT SPLEEN KIDNEYS ADRENALS I)TFRUS ARATN s so I so ----m.0------------------m -------- 2o941+-0646S 0.269#-06036 OelSV*-O6D3J 0.62t*-Ob88O 0.020+-Oiooaa 001614-0005!2 Oe4O8*-O*O?7 4.903+.0,9590 00308+-0*070 00178+-00028 0*093+-0.152* 0.12?+-0.010 0.253*-O,loso 00099+-Ooo9s* N z 19 Na so --------------- 34679*-OiS230 Ob2?9+-Oi94l Obl6?+-OiO4? 0*706+-Oillo ob027+-OoOll 3*335* 0.279* 0*154* 0.6al* 0.030+ ObIM9+-Ob864 0643?*-OiO6S 0.*177# 0*410+ # : P <= .059 TWO TAILED DUNNETT I ON RAW DATA, CD 0 : P <= oost TWO TAILED DUNNETT T ON RANKED DATAO% A : N = 13 ANIMALS. A : N = 14 ANIMALS* -TABLE 18 TWO YEAR ORAL IDIET) TOXICITY-014Ct)ULNICITY STUDY OF FLUOROCARRON ABSOLUTT AND RELATIVE t4t.ANORGAN WEIOHTS FM-39P4 I OM(3AN wEIbMT/MRAIN WEIGHT (RATIO) 0 PPM 100 ppm 30 VIJM --------------- --------------- ------------- 10 pp MALE N a lb N = 15 N a 15 N ORGAN KATIO su MATIO St) RATIO so RATIO -------------------4 ------------------------------f-t----------------------- LIVER HEART SPLEEN XIDNEYS AORENALS TESTES 8.648*-loS87 oo8l9#-oolo3 O.S?R*-O.lb5 2oO99*-0*377 0*03f%*-OoOl(i 1.6SB#-0*33b 10.65*-1952?* 06818*-O.Ios ou36**-0.042* ?*127*-0*246 0%039+-0.0094 1*714*-0.284 9.686+-lolo7 o."4l*-DolO4 (19460*-0*076* 2*llq*-0*242 4.04at-00021 I.SVOO-0.203 8e47O 0*1432 0*475 2,017 OoO46 1.721 FEMALE N c 15 .4 I-S N a IS N ORGAN RATIO Sal) OKATIO so 04ATIO so RATIO ---------------------------------------------------------------------------- LIVER HEART 7.456*-1.91" Oo6t34-G.lOO Oub23+-0.100 8*651*-29060 o*63s4-0.00? 14.5142 0,649 SPLEEN xinNEys ANRENALS UTERUS 0*394*-0.070 1.543*-O.Ibb 00050+-0002?H 0.404*-0.15b 0*367*-0.091 14599*-0.172 obo54*-oool8 04502*-0.161 00386*-Oolo? 1.637*-0.25? O.O63*-OoO26 0.43,v*-ool4'ri 0.391 IIS69 01073 0*43h P <= OS9 TWO TAILFO L)UNNFTT T UN kAW DATA. 0 : P <a 059 TWO TAILED OUNNETT t UN RANKEI) DATA* A : N = 13 ANIMALS* CD 0 : N 2 14 ANIMALS. @h TABLE 18 TWO YF.AP OHAL filit.Tl l(iXICITY-fit-,(:IlfitNlCITY STI)IDY OF FLunitoCAm"nN F#4-.Io?4 IN FAAL@ WAYS TwillYtAii INIIIVIIIIIAL omiAN totli;"TS(G) DOSF 0 PPM 0) PP94 a PPOA 0 ppm a PP" 0 ppm a ppm a PPM n ppm q PPFA o PPM 0 PP14 n ppm 0 PPM 0 Joe 100 ion IOQ Inn Ion PP" PPM PP" PP44 PP04 PP" PP" too PP" ion PPM loo ppm 100 ppm 100 PPM 100 PP" 100 PPM Joe PP" 100 PP% ANIMAL AIR35114 A 1143cZ4 AIR39*29 AIPIci3l AIP]r%33 A IR is 3it A 14 -isi42 AIR3c649 A I P 3CIS4 AIH35SI Alp3s62 A I P 38;64 A I R 3-,Fi9 AIR3S?3 AlR3S?g 4141700 14164 3 7 a.? "IRI?ob RIP37ng 64103? 13 14IR3719 R143?PS R143730 HIPI?39 NIPI?41 4141?4h pi"37-bz 41RIISS NIRI?SQ 0141160 1400Y Sv$b 638 "I? ?33 7 &Ct ?As ?'1] 706 NJ? t-12 SA14 S76 696 7%9 5?1 h43 66'3 hi?4 &)If% 6?ci 6?4 Li44 t$14 3k%9 stio fifin #$I? &#A 7 tWO2 sq;? L I V@-N lSel2 23.*'N 14*tol 1 ? 091? IROOT ?1.1,17,60 ]A*44 14014 17011 1 gi. It* 1 FIO?N ?Ioi&4 ?7041 130%? .11 ?30 io'p a4 0 ie4oAP 22*29 i!lo?S 29*6*7 2h.41" ?f)084 1 A. L)7 2n 0;1.3 190 *13 IS,43 7 4) 4)1 21 111 HFART I.b;jl 1.511 1.7144 1 .1471 1.617% P*iAsl 1 .&1616 i.hh? 1 LI47 1.7046 10616 lohtq ?.I?? loh?9; 1.63104 1 oq;! I 104'17 I . 7 flI 1."?0 1,40%014 l.h4s ;*I a 37 let17h lobsi 1 of#SCD 1 06PI4 10361 1 447% l.s9o 1 tid?9 %PLF@ N 103)" 1.414 1.111 (),RIO n.qql 100443 11* r?" 1.1*ti 1.131) 1 * I (Ih 1 0 iti4 lolyh [.Still fle9ni Q,qnn n , 04.;P 1.1"4 nomfit DOH?H 00?Yff O,h?4 0,4,-? 0*729 fiesof) 410?"*A 4009,44 n.401 neh3i 110731 K II)NF Y% 3.,413 46.1446S 4 0 4#;@4 3084? 4.% 460 4.0.13 40,SIO 3.4t*7 4.?Im .3. 1 f#S h. 4 111 S.011 3o641 16.2AG 404is 4. 9Hg3 40%hi S.nA44 4.301 S,044 4.3%6 a. ?Ltd# 4*371 400?4 I.SLIS ds. 1,,n, :4.0(1#1 AlifiFNAL hn 57 147 7L. ]on 44 914 73 04 n hi 11 -4 1011 11-4 I'l fv;) hq3 1"47 4& b 67 ?01 Q'i 7z-b is ?IV ?a 1? 76, ADRENAL WEIGHTS ARE IN MG. C:) ADRENAL WEIGHTS NOT TAKEN. ONE ADRENAL INVOLVED WITH A MASS. @4 TABLE 18 TW(i YEAR OkAl- 4itiFT) TOxl(:ITY-(INCI)(io@NICITY STIJI)V OF FLII()040CAR14ON FM-114?4 JOY .4ALF HAT, T Wi) YEAH INIPIVIDOIAL t$HiiAN Wi li-ol4TS(G) oosr AN IMAL 14opy I-1 Vf" NFART %PLFFN K 1 nNf Y,, ANPF NAL TF% 30 PP14 30 PPM 30 PP" 30 PPM 30 PP" 30 PP$4 30 PPM 30 PP04 30 PPM 30 PP04 30 PPM 30 PP" 30 PPM 30 PPM 30 PPM is PP" le PPM I$ PPM 10 PP" In PPM 10 PP" In PP" In PPM le PP" 10 PP#4 10 PP14 10 PP04 10 PPM 10 PPM 10 PPM Clo]741 ClRl?fo3 CIA37fil CIR3?69 CIR3?73 CIP37?6 CI"3779 CI"3701 CIN3706 CIR3?08 CIRI?91 CIN37Q4 CIR3?99 C103403 Clulan? #IIR3Rll nIP3414 DIR3417 I)IR3R?2 DIRIR?6 nIA3879 nlP3R3Z nIR38ii (IINIA41 DIP144S DIR3A4R nIR3A%l DIPIAS3 DIRIAC;H nipiftsa f-73 642 7146 ?24 rp4 A %%1 fi.34 si9ot 6tin #101 ?1? Fifil Too Sol #104 TA3 607 602 70)" fi)2 570 ?S? f%9f, %?1 ri6a 0 ? -t 674 %?Ft lhn6 S54 19oh4 21.54 71003 2490S 20.14 ?1.37 19,?V 10,09 70026 19007 23.03 ?gi,Oi ?0*44 18007 17*01 ?4067 16*46 loot$? 16.214 16*fi" 17. (ly POOJO 21 o104 16017 lu,(Ig ?101" 21.12 IS*O'I 14.4? 171-34 107014 100114 ION75 1.111 10410, p 0n 1.@, l,h4h 1 c;bln to@%"o 1,6!il) 104,63 ?0?74 I.Ift? 10641 I.?Sj 20171) lopiati IOYPO 19144 loft?) I or)14 20070 1.704 pool') I . ?of% l.bbi 1 .641# 1.1443 107"1 0*6@R4 10034 OOQ%H loll4ft )*?79 10ocis 0.48,1 00976 0*913 1 0(OPi 100,11 ".iR?h 1*007 no4sp 0 0 9GJ9 1.%21 n.9r,,? OoFk"% 1*07"1 1.413 0*691 I*OQI 102%14 19014 00"09 IOPR2 11041f, O,R&10 (1,1%45 n*plo 4.461 4.414 40407 406?i? 4 0 tb'l1 %.?SO 4ol9q 4.176 4040" 3 014?A 4oc%96 5 .4 4*797 4oO'4" 40017 4OS35 1."14 394'1% 306tib 4e2RA 4. 70404 40h"4 494Sn 49h?3 4*04011 Soii%h 4*444 4 0 6is4 4. o?f)1 401(14 74 Ito A& RA 74 210 1114 Inq AQ To NO 9? 6A Ion qc; An 121 1?2 "h ?n loot A4 ?? ?1 74 I QFI b 0 Q'i 97 A4 10 is ?Got .46H 3*1 3.7 3e3 403 -4,v ?67 309 .163 2*2 -4,ft .106 3.7 3o3 36t. 4,14 31.4 4.3 4bO 30? lbft 36FI ?o4 leb ?00 ADRENAL WEIGHTS ARE IN MG. C) ADRENAL WEIGHTS NOT TAKEN. ONE ADRENAL INVOLVED WITH A MASS. TABLE16 TWO Y@.AR ()HAL 4111@.T) TOXIC ITY-Ol4CO(IrMICITY ,;Ttofoy fi@ FLUORtICA64NON IN ftMALF 64ATe, TWO YEA14 iNitivintiAL ON4.4AN wt-litt4ici(G) DOSE ANIMAL ROOY LIVFP wi@ANY '%PLEF N K I 'ONE Y% SI)OFNAL a PPM N IR46in 3 4q& 1 Q9 1 1 r4 10032 1 *.1kh$4 404 0 PPM a PPM a PPM 0 PPM k 1 "4-%Ah NlR4r,91 WIR4%9S N 1 p4s9q f#po S16 4rs 471, I *"I% 14021 110904 l3a4S 1 .?191 1 31?? 100615 I *hJ,4 00491 1)1 ?44 fj,74(1 ltoo4al #00N?4 J. IhI ?. ?hot 3 0 4#66 61 A4 on b 0 PPM WIR4603 4PI 140.17 194#1% fl,b%l .1-21" 44 0 0 PPM NIR4606 %q2 14.09 1.641 ll*757 30374 114 1 0 PP" NIP4611 604 24014,R I.Sh? fio?21 3031" ?r%,% 4 a ppm N104616 5;1 " 14044) 1644R il.h9? 303416 a PP" NIR&616 3pi 7 1107? lo?s4 is.71 1 3 0 111 P a 0 a 0 a 100 100 100 too 100 PP" ppm PP#4 PPM ppm PP$4 PPM PPM PP14 PP" hin&626 NIR462" NIP4634 NIR4636 NIR4630 OIR47%9 CIR4?64 OIR4?67 OIP4?64 OIR4?73 3%3 S3% Sh? siho 675 47% 3?6 39.70 3047 3?'] 10*?14 l.,4e34 190?3 196st 160?R 22*kl lle"3 1fta20 19001 140%.'1 o.v4,) 1 0 1";! 1 *%*Jl 1,1"n l.hi? 10.'104 0.91)2 alio;ph 1*25% 1023-1 nor-hi it.430 110 'Shi loo4l.) 61,1,4" n oy44 "*%not if0 obs4 tl,hL)4 li,hiy ?.4ts4 390042 ?0070 3*?61 303,40 301')S ?.Ah? .1006? 30314 '40044 ?H a 7(1 n 1014 a As ol Tr% a 9a 0 ks6 4 lih 0 Ilk I 100 PPM OIR477A 4?2 lho,414 1.3@-,l I.Ohf# lo%13 191 0 IGO PPM OIR4?44 473 21*ho I O?Ici ll,%Hm 3.411's 644 1 Ion PPM OIR4?96 419 170.'Il 1,114 0067(1 ?IfbAy 66 1) Ion PP" 0144POO 348 lsesil I.?]" fl.hyt, ;I.ft4y I?, I 100 PP" OIR4403 477 2'loisn 1.29%6 11,640 'J.,bAA a? a 100 RPM 100 PPM too PP" OIR4AO4 OlA4Rll OIR4AI4 3gol 4r# 7 441 340?1 2'1*1)1 23.03 illin 1.444 I.Inti fio??h 11.An ii O.Ifit ?.The% 1 ##0%9 .1 3049 11.3 1 11% 11 4s left PP4 0104017 fill 2?9%0 loihhl 1017h .1.441 q3 Ion PP" OIR4414 ?042 14 *gin 1.4h.1 a rb,4 0.10604? 44 0 ADRENAL WEIGHTS ARE IN MG. C:) ADRENAL WEIGHT NOT TAKEN, ONE ADRENAL GREATLY ENLARGED. TABLE 18 TwO YKAR ORAL 41)[@T) ti1xiCITV-ONCli(i@NICITY STlinY 4lf FLIJ(DRI)CAP#ION @Ot-44@'4 IN @KMAL@ "AT, TWO V@Ail INIOltilDIIAL liwilAN Wt lt;ht';(G) &NIIWAL "tiny LIVFH HFART ;PLFF$4 K ItiNt.YS 30 PPM 30 PPM 30 PP" 30 PPM 30 PPM 30 PPM 30 PP04 3n PPM 30 PP#4 30 PPM 3n PPM 30 PP" 30 PP14 30 PPM 30 PPM In ppm in PP#4 in OPP 10 PPM in PPM le ppla 10 ppm 10 PPM le ppm le PP'4 la PPM 10 PPM 10 PPM In PPM 10 PPM PIR4473 PIR4626 PIR4477 PIR603? PIR4434 PIR4036 pip4njq PIR4444 pl"&A4q PIR4Rs4 PIR40ci PIR4A54 PIR44sq plp4A64 PIR446Q Qlp4RT7 GIR4R?i QIR4016 olp4RAl f)lR4FkR2 I)IP4RF%4 ljlR4RFkgi alp4ag? GIR4494 olR4R97 UlR4Qn3 01RA914 GIR4916 OIR4919 QIP&919 613 374 397 S4? 473 SO? 46#. 337 40'4 4io? 600 443 401 4AT S14 36,p 51? 41? 1543 ft46 as sgin 740 4%1 489 I?p fi&gi 67? ?96 476 ADRENAL WEIGHTS ARE IN MG. KIDNEY AND UTERUS WEIGHTS NOT ADRENAL WEIGHTS NOT TAKEN DUE 20060 140043 14,%6 19047 ?oob3 lso"3 14.14 130@il li#94H lb*O I 21 .*Do 16* Ito liosq 17044 lieby 13096 13.tjft ?0*9h 1906S ?I Ohft I I . dot- 24)tz? 14.17 13o4h 11.21 2006H ?91 * 1?6 50,11 1 4 i.o74 1.11314 1 . I-iI 1.4147 1OPI,4 1,JO? 1.6.7s. 1 1n,is 0.8t*ov tolol., l,jl4 I .?Ih 1.311 I'll#$ I..Iol 10?39 I.S(la) i,iiell 1 0 tob4 1,44h i.osh I.slf ?*Ihl tol7ii 1.314 1.14? 1 *4dil 1 Lwhil 1,1164 1.. I.ih 0046c, lefoll ii.S43 no%41 1)0tsi;l n.holi Ao?44 0.6hoi a Otio@H nomtl a e414 1 4.7414 0*604 O.Ii?y I.Plo 0 0 w@lis n OhLi% n.fv6i4 n.614 (lo444 1 0is##& ne"?O n*m?h n.Lwflr f)."R? 1.047 n.344 f) 9 A@.fI TAKEN DUE TO CONGENITAL ABNORMALITY. 10 INVOLVEMENT WITH MASS. '1.1114 J. ep4l@ i$0 6)4h -1.4047 ?*431 3 o'31&s 7 a ? 914 3o 14,@* i#.131* 30 14#0 '10 S31i 7ohnil .1o,ill 30'114 300)13 z. 9%44 ?*$It% ?.s4p 3eann .1.)?h 0b I.GNI I 4.017 t'IM141 J.344 ? *'%Itj lohmi loOh4 0 @lot ?It ADI@FNALC 209 190 "4 904 4;0 I 4;@ f46 ini 17" 1%4 IS#4 6A 414 94 74 Ion Q6 114 ots; IRI tp?o liq 193 ?07 19" 1C64 125 ilT@14 oeso 0 a it) I.IC 1 st a,ft 066 009) 100 0,04 O*N 017 nor 0,-# I)OLJ ion lb2 n .C% (), Lo 1.4 0,4 It 0,14 004 0.4 ()Oh nos 163 066 fl.7 1*0 TABLE 19 Two Year Oral (Diet)Toxicity - OncogenicityStudy of Fluorochmical FM-3924 in Rats Summary of Major Microscopic Findings - Percent Incidence at Two Years Organ/Findings ADRENAL Pheochromocytoma, Benign Pheochromocytoma, Malignant LIVER Hepatocellular Carcinoma HepatocellularAdenoma MAMMARY GLAND Adenocarcinoma Adenoma Carcinoma Fibroadenoma PITUITARY Adenoma THYROID C-cell Adenoma C-cell Carcinoma UTERUS Polyp NEOPLASTIC LESIONS! Controls Malo Female so- 50 High Male Female so 50 4 4 0 2 0 0 0 0 6 0 0 0 - 15 - 7 - 2 - 22 4 6 0 8 - 21 - 0 - 0 - 13 35 72 43 71 0 2 2 2 5 0 2 4 - 2 - 2 Mid Male Female 50 50 8 0 0 2 2 0 0 0 - 24 - 0 - 0 - 33 60 82 4 3 2 3 - 9 Low Male Female 50 50 8 2 2 0 2 0 0 0 - 13 - 0 - 0 - 36 47 76 7 2 0 2 - 8 a No statisticallysignificantdifferences(a- 0.05) were found betweenrats fed diets with FM-3924 and control group animals. b 50 rats/sex/groupwere at risk; % values derived from actual tissues examined. TABLE 20 Two Year.Oral(Diet)Toxicity- OncogenicityStudy of Fluorochomical FM-3924 in Rats Sumary of MaJor Nicroscopic Findings - Percent Incidence at Two Years NON-NEOPLASTIC LESIONS Organ/Findings Controls Malt Female 50- 50 HiQh Male Female 50 50 ADRENAL Nodular Hyperplasia 4 0 22* 2 Sinusoidal Ectasia 22 84 30 68 Cortical Vacuolation 48 10 36 22 HEART Myocardial Fibrosis 10 4 10 2 Myocarditis,Chronic 28 32 30 4* KIDNEY Nephropathy, Chronic es 60 86 36 Pelvic Mineralization 8 60 LIVER 0 66 II - 11 Cystoid Degeneration 8 0 30* 8 HepatocellularAlt.Vac. 20 26 18 12 HepatocellularVac. 44 60 78* 82 Hyperplastic Nodule 0 Megalocytosis 0 2 10 18* 0 84* 88* Necrosis 6 10 20 8 LUNG Alveolar Macrophages 20 28 46* 54* Perivas, Mono.Infil. 42 26 14* 38 Vascular Mineralization 86 44 96 78* Pneumonia,Interstitial 32 14 12 18 TESTIS/EPIDIDYMIS Polyarteritis 12 - 4 - Vascular Mineralization 0 - 12 - OVARY Tubular Hyperplasia - 0 31* THYROID C-cell Hyperplasia 2 0 9 9 URINARY BLADDER EpithelialHyperplasia 7 14 UTERUS Cystic Glands - 14 4 4 - 29 Mid Male Female 50 50 0 4 40 78 30 14 12 10 50 14 80 52 16 48 16 0 32 12 38 so 2 0 56* 2 0 12 30 30 40 20 88 84* 14 12 4 - 4 - - 23* 6 11 13 5 - 13 Low Male Female 50 50 10 0 10 72 20* 10 20 6 40 is 88 44 16 46 12 0 24 12 24 54 0 0 54* 0 4 10 36 28 30 18 90 80* 8* 20 8 - 14* - - 13* 4 0 2 0* - 17 a . 50 rats/sex/groupwere at risk; % values derived from actual tissues examined. - Statisticallsyignificantdifference 0.05) from controls. 112. Figure I Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Mean Bodv Weights (g) Males 71 E A N 0 4 D 51W y w E G H T s 1 I 30@ N R A s loo@- r"rite-IlIIIt*II$-IIqe stv-s-sIallIlI-II#'@IIsI11-11-I#rvI IIIIerg #-81-111'1 1fl-o 10 20 30 40 50 so 70 as as STUDY WEEK LEGENDs GROLJP *--*CONTROL 100 PPM -o--+30 PPM *--+-10 PPM Figure 2 'twoYvar Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Medii Body Weights (9) Femdles 7W m E A N 50- 0 D y 400 w E I G H T s I N c R A m s toisr'lrrilits i,ire,it-totoI-roIIs#I#IIs-r#llIIitsto$its$-$bell011-0.$0-to 0-9-1 10 20 30 40 50 as 70 Be go to STUDY WEEK LEGEND& GROUP CONTROL - 100 PPM 6 s 30 PPM 10 PPM Figure 3 Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Mean Food Consumption Per Kilogram Mean Dody Weight Males F 0 0 c 0 N s um loop T I 0 N G G 0 D y w T Trr"vll-tol"l fit y 0 10 29 30 LEGENDs GROUP 40 so 60 70 so STUDY WEEK *-*CONTROL 100 PPM 30 PPM 90 100 10 PPM Fiqure 4 Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Mean Food Consumption Per Kilogram Mean Body Weight Females F 0 0 D c 0 N s um teap T I 0 N G 5iH G B 0 0 y w T y0 ers lirro sirt-to tlrito I I-,-$ eirro III re gas re it III-"ttvtt-r 10 20 30 40 50 60 70 so 90 1 STUDY WEEK LEGENDE GROUP @m-m CONTROL - 100 PPM 30 PPM 10 PPM TWO YEAR ORAL (DIET) TOXICITY / CARCINOGENICITY STUDY OF FLUOROCHEMICAL FM-3924 IN RATS APPENDIX ITEMS 1 17 InternaClorrespondence Appendix Item A cc: F. D. Griff'Lth - 220-2E-02 W. ". McCorm'-ck - 220-2E-02 rc: J. K. Sugg - 220-2E-02 F. A. Ube!-, M.D. - 220-2E-02 -c,--,MT.. CASE - RIKER LABORATORIES - 218-3S ;:,o,S-. D. SORENSON - MEDICAL, IND. HYG. SERV. suc.ec: Air Monitoring, ProJect 89003107 '-'e@a,August 27, 1981 220-2E-02 3M Summary 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 exposures, if any, were below detectable amounts. knetall Air sampling was conducted in the three animal treatment rooms used in the two year animal feeding study'of PM-3924 and FC-143. The study has been in progress 31nce April 21, 1981. Area samples were collected in each of the several treatment rooms by means of either impingers with methanol media or SKCO 31liCa 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 perioda 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. ,he 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. 1 18 Appendix Item A .4. T. Case -2- August 27, 1981 The sample results Indicate that airborne concentrations or the test fluorochemicals, if any, were below detectable limits. On th13 ba313, It is judged that cross contamination potential by airborne means Is unlikely. Please call of there are any questions. SDS:cr 1 19 M. T. Case Sample Data Building 219-3 Project *89003107 August 7, 1981 Appendix item A -3- Sample Number CCrLSI-20 CCIA 1-2 3 CCL81-21 CCLSI-25 CCIAI-22 CCL81-24 - Description D-340. control Rom, top of rack. Same as above D-332. rM-3924, dose POM. S=Pler an top of high dos* rack. D-332. Sampler at rear rom air e3thaust about 16 Inches above floor. D-336. PC-143, done RO=. Sampler an top of high done rack. Same as Ct7AI-22, duplicate amWIe using silica gal tube. Time 922-1225 922-1225 926-1236 1055-1236 925-1228 931-1228 August 27, 1981 Comp@aund FM-3924 FC-143 PM-3924 F'M-3924 Concentration, mftg/m3 ( 0.003 'c /,o.ooi 40.1,-rb <0.003 Ce.3,-Fk /,0.02S FC-143 FC-143 /,o.ooi 0.002 a. SAKPLING METHOD: P?4-3924 9= silica gel sampling tubes. IPC-143 ZmpLnger - methanol. A?4ALYTICAL METH.MI ANALYTICAL REQUM: P2[-3924 - gas chromatography, electrcm capture detector. FC-143 - darivatizationi gas chromatography, electron capture detector. #AB0248. 120 InternalCorresPondence APPENDIX ITEM A To: L. J. Sibinaki From: J. D. Johnson Subject: Date: Analysis of Plan= Samples from Sentinel Rats Housed in Room with Two Year Tox Study-Rats (Riker Study No. 0281CROO12) October 7, 1985 I have attached the one page protocol attachment for the use of sentinal rats in Riker Study No. 0281CROO12. These samples were collected as described. On July 15, 1981, forty plama 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 loan than one 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. Jaa'mmaess son jRR@eseoeaanrrcchD T ccaicaalint Riker Laboratories, Inc. 121 Appendix Item A InternCaolrrespondence cc: M.T. Case F.D. Griffith R.E. Ober w.it.Pearlson R.A. Prokop To. V. Pothapragada From J.D. Johnson Su*= Analysis of Plasma Samples from Sentinal Rate Housod in Room with Two Year Tox Study Rats (Riker Study No. 0281 CR 0012). Do*. July 15, 1981 Forty plasma samples from sentinal rats at* submitted for fluorine analysis. These samples include S male (IR 3861, IR 3862, IR 3863, IR 3864, and IR 386S) and 5 female (IR 4921, IR 4922, IR 4923, IR 4924, and IR 4925) which were sacrificedbefore dosing was initiated. The other thirty plasma samples were collected at 30 days artac do-.ing started. There are S 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 are receivingPM-3924. The numbers for th*se.rats are an follows: 5 male Control Roomi(IR 3866, IR 3867, IR 3868, IR 3869, IR 3870) 5 female Control Room (IR 4926, IR 4927, IR 4928, IR 4929, IR 4930) 5 male FC-143 Room (IR 3876, IR 3877, IR 3876, IR 3879, IR 3880) 5 femle FC-143 Room (IR 4936, IR 4937, IR 3838, IR 3839, IR 3840) 5 male FN-3924 Room (IR 3886, IR 3887, IR 3888, la 3889, Ili3890) 5 famal* PH.-.392R4oom (IR 4946, IR 4947, IR 4948, IR 4949, IR 4950) Pleaseget back to us with the data. It may be that interpretationof the resultswill lead to specificanalysisor to analysisof tissu*. *Do D2.@jJ?..90@ 122 Appendix Item A IAK A-iq3 A 154 Ills' IR itg 1941 m $irt,N 3t 6 4 3t ilia%? A^-"I ,2ao .201- L, 4 fl 41 1 S* r- vi I.aLy.?I ALI Ala -111 aq 103 4L 2OL4 31s(,-l 2:v 2-at Zo7 '6,iLi 20% 4L 411 *3 dl @q3c r 13 R -i s c 7-i m f7 '11%' 3 1 i- 1:'C - 4 -fd22-11 123 Appendix item A c C-D A RE /(CA Rig 211 If,4tCl'b b F lft4431 .2 2v i 2. f 2?.3L.- Ioz '3940 Fe. flu 4L@x to-s-igi *y 2.1-JA li,3st/. #4 '53 1.4 4%rf*- dL/ Ilk 3@g it-1 1 11-@ 3 e t ;,R IR 22$f 2@30 @4-4,j 4 -7 F: j,el iiZ 491 6;'c) A flit, 124 Appendix Item B Two Year Oral (Diet) 7bxicity - Oncogenicity Study of Flurorcarbon F14-3924 in Rats kal*nding Procodwe of rvl-3924 Diet CXmcentrate 1. FM-3924 (0.24 g/kg of diet to be mixed) was dissolved in ethanol-S (approximately 6 - 10 ml) in a 10 ml graduated cylinder. 2. 7his solution was "sprinkled" in layers of non-treated ground diet to be mixed. The graduated cylinder was also worked with an additional 5 ml of ethanol and this also was "sprinkled" into the diet. 3. The treated diet was physically mixed for approximatly 20 minutes using a Hobart'O blender. 4. After mixing, the FM-3924 diet concentrate was spread out in stainless steel pans (66.5 cm long x 40.7 cm wide x 3.0 cm deep) and placed into a fume cabinet for approximately 72 hours to b evaporate the ethanol:--. This procedure was done on a weekly basis to yield a FM-@@3924 concentration of 200 ppm in diet. U.S. Industrial Chemicals Co., Div. of National Distillers b Chemicals Corp., Chicago, IL; 190 proof; Lot #480316. CCD Analytical Report #213 revealed the level of ethanol (ETOH) in the FM-3924 diet concentrate after drying to be less than I ppm. 125 Appendix Item B CCD ANALYTICAL REPORT #Z13 TO From: P. J. Colbert - 236-2B GLC Analysis of FM-3924 (T-2999CoC) FC-143 (T-2998CoC) Subject: into Ground Lab Chow. (Riker Study #0281CROO12) Date: April 29, 1981 Blended Reference: Commercial Chemicals Analytical Laboratory Requests #17079, 17080, 17096 Commercial Chemicals Analytical Laboratory Method t's G30-0481. G31-0481 The samples of FM-3924 (W.R. ETFOSE) blended into Ground Lab Chow, along with four blank Ground Lab Chow samples, were received from L. J. Sibinski on 4-20-81 for analysis. All samples were run in triplicate. The results are: Compound Theoretical ppm Actual pprn ug/g FM-3924 Blank for concentrate 0 FM-3924 Concentrate 200 (blended 4-17-81 ) FM-3924 Top Sample 100 Mid Sample 100 Bottom Sample 100 0 214 105 105 /C"i ill FM-3924 Top Sample 30 29 Mid Sample 30 27 Bottom Sample 30 30 FM-3924 Top Sample 10 Mid Sample 10 9 Bottom SAmple 10 10 126 APPE.NIDIX ITEM B L. J. Sibinski CCD Analytical Report April 29, 1981 Page 2 #213 Compound Theoretical ppm Actual ppm (ug/g)FM-3924 Blank for 100 ppm level 0 0 Blank for 30 ppm level 0 0 Blank for 10 ppm level 0 0 The level of ethanol in FM,3924 Concentrate (blended 4-17-78) was also checked and found to be less than I ppm (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 4/20/81 for analysis. All samples were run in triplicate. The results are: ctual pprn ound Theoretical pp..l (ug/g)FC-143 FC-14 op Sample 300 326 Mid mple 300 282 Bottom ple 300 297 Blank for-300 ppm I 1 0 FC-143 Top Sample 30 24 . Mid Sample 30 23 Bottom Sample 30 2 8' Blank for 30 ppm vel 0 Because two the three 30 ppm level samp were low, anotherl set of sam es were received from L. J. Sibin i on 4/27/81 for anal is. The results are: 127 dc: M . T. Case E. G. Lamprecht 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 236-28 236-2B Coniic-rcialChemicals Analytical Report #229 Appendix Item B To: From: P. J. Colbert 236-2B Subject: GLC Analysis of FM-3924 (T-2999 CoC) FC-143 (T-2998 CoC) Blended Into Ground Lab Chow (Riker Study #0281CROO12) Date: June 15, 1981 Reference: Commercial Chemicals Analytical Laboratory Requests #17172, 17173. Commercial Chemicals Analytical Laboratory Method #'s G30-0481, G31-0481. Ten samples of FM-3924 (W.R. ETFOSE) blended Into Ground Lab Chow, along with three blank Ground Lab Chow samples, were received from L. J. Sibinski on 5-18-81 for analysis. All samples were run in triplicate. The results are: Sample Theoretical pp Actual ppm jig/g FM-3924 FM-3924 Concentrate 200 208 (Blended 5/15/81) Blank for 100 ppin 0 0 FM-3924 Top 100 109 Mid 100 108 Bottom 100 96 Blank for 30 ppm 0 0 FM-3924 Top 30 33 Mid 30 31 Bottom 30 27 Blank for 10 ppm 0 0 FM-3924 Top 10 Mi d 10 Bottom 10 11.3 11.5 10.0 128 ,1. 1. - , ,--- E. G. Lamprecht - 218-3 J. D. LaZerte - 236-1 W. C. McCor7nick- 220-2E-02 V. Pothapragada - 236-3A R. A. Prokop - 236-28 L. D. Winter - 236-2B 6. W. Kirscn Appendix Item B COMMERCIAL CHEMICALS ANALYTICAL REPORT #251 To: From: SLoect. Date L. J. slelnSXI..- 218-3-3 P. J. COLBERT - 236-2B GLC ANALYSIS OF FM-3924 (T-2999 CoC) BLENDED INTO GROUND RODENT CHOW (RIKER STUDY #0281CROO12) September 8. 1981 Reference: Commercial Chemical Analytical Laboratory and CCD Method 630-0481 . Ten samples of FM-3924 (W. R. ETFOSE) blended into ground rat show, along with four blank ground rat chow samples, were received from L. J. Sibinski on August 17, 1981, for analysis. All samples were run in triplicate. The results are: Actual ppm Sample Theoretical ppm g!g FM-3924 Blank for 200 ppm 200 ppm Concentrate 0 0 200 214 Blank for 100 ppm 100 ppm Top 100 ppm Mid 100 ppm Bottom 0 0 100 110 100 0'108 100 112 Blank for 30 ppm 30 ppm Top 30 ppm Mid 30 ppm Bottom 0 0 30 31 30 -TO &7 31 30 30 Blank for 10 ppm 10 ppm Top 10 ppm Mid 10 ppm Bottom 0 0 10 15 10 0:6 10 @llO.0 Pic/hc 129 Appendix-Item B COMMERCIAL ANALYTICAL CHEMICALS REPORT 0290 To.. From: Subject: Date: R. M. PAYFER - 236-2B I G LC ANALYSIS OF FM-3924(T-2999CoC)BLENDED RODENT CHOW (RIKER STUDY #0281 CROO12) December 1, 1981 INTO GROUND Reference: Commercial Chemicals Analytical Laboratory Request #17780 Ten samples of FM-3924 (W.B. ETFOSE) blended into ground rat chow, along with three blank ground rat chow samples, were received from L. J. Sibin3ki on November 16, 1981, for analysis. All samples were run in triplicate with the following results: Sample Theoretical PPM Actual PPM FM-3924 200 PPM Concentrate 900 Blank for 100 PPM 0 100 PPM Top 100 100 PPM Middle 100 100 PPM Bottom 100 Blank for 30 PPM 0 30 PPM Top 30 30 PPM Middle 30 30 PPM Bottom 30 Blank for 10 PPM 0 10 PPM Top 10 10 PPM Middle 10 10 PPM Bottom 10 RMPIhc 217 0 108 103 104 0 291, 29 31 0 9.4 10.1 9.5 dc: 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 R. A. Prokop - 236-2B L. D. Winter - 236-2B (2 copies) 130 dc: M.T. Case - 218-2 G.W. Kirsch - 236-3A E.G. Lamprecht - 218-3 J.D. LaZerte - 236-1 W.C. McCormick - 24@'J,-2E-02 V. Pothapragada - 'e.3.-'o-3A L.D. Winter - t'36-28 Appendix Item B COMMERCIAL CHEMICALS ANALYTICAL REPORT 0320 To: L. J. SIBINSKI - 218-3-3 From.R. M. PAYFER - 236-28 Subject:GLC ANALYSIS OF FM-3924 (T2999 CoC) BLENDED INTO GROUND RODENT CHOW (RIKER STUDY #0281 CR 0012) Date: MARCH 5, 1982 Reference: Commercial Chemicals Analytical Laboratory Request #18072 Ten samples of FM-3924 (W.R. ETFOSE) blended into ground rat chow, with three blank ground rat chow samples, were received from L. J. on February 15, 1982. All samples were analyzed in triplicate for with the following results: along Sibinski FM-3924 Sample 200 PPM concentra te Blank for 100 PPM 100 PPM Top 100 PPM Middle 100 PPM Bottom Blank for 30 PPM 30 PPM Top 30 PPM Middle 30 PPM Bottom Blank for 10 PPM 10 PPM Top 10 PPM Middle 10 PPM Bottom Theoretical PPM 200 0 100 100 100 0 30 30 30 0 10 10 10 Actual PPM ug/g FM-3924 198 0 107 106 103 0 31 29 24 0 8.8 9.0 7 RMP:df 131 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 - 236-28 L.D. Winter - 236-2B Ta Appendix Item B COMMERCIAL CHEMICALS ANALYTICAL REPORT #327 From- R. M. PAYFER - 236-2B GLC ANALYSIS OF FM-3924 (T-2999 CoC) BLENDED INTO GROUND RODENT CHOW (RIKER STUDY #0281 CR 0012) Date: MARCH 22, 1982 Reference: Commercial Chemicals Analytical Laboratory Request #18101 Three samples of FM-3924 (W.R. ETFOSE) blended into ground rat chow, along with one blank ground rat chow sample, were received from L. J. Sibinski on March 8, 1982. These samples were analyzed in triplicatewith the followingresults: Sample Theoretical PPM Actual PPM Ug/g FM-3924 Blank for 10 PPM 0 10 PPM Top 10 10 PPM Middle 10 10 PPM Bottom 10 0 10.6 9. 7 9.9 @.czz@ /$ RMP:df 132 Appendix Item B COMMERCIAL ANALYTICAL CHEMICALS REPORT 1341 70 Frorr. Nie R. M. PAYFER 236-28 GLC ANALYSIS OF FM-3924 (T-2999 RODENT CHOW (RIKER May 28, 1982 COC) BLENDED INTO GROUND STUDY #0281 CROO12) Reference: Coninercial Cheinicals Analytical Laboratory Request #18320 Ten samples of FM-3924 (W.R. ETFOSE) blended with four blank ground rat chow samples, Sibinski on May 17, 1982. All samples were FM-3924 with the following results: into ground rat chow, along were received froon L. J. analyzed in triplicate for Sample Theoretical PP Actual PPM ug/g FM-3924 200 PPM Concentrate Blank for 200 PPM Blank for 100 PPM 100 PPM Top 100 PPM Middle 100 PPM Bottom Blank for 30 PPM 30 PPM Top 30 PPM Middle 30 PPM Bottom Blank for 10 PPM 10 PPM Top 10 PPM Middle 10 PPM Bottom 200 0 0 100 100 100 0 30 30 30 0 10 10 10 199 0 0 100'. 101 95 0 30 "209 I-W 0 10.5\ 11.9 10.9 CIO'/44r., RMP/hc 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-GB L. D. Winter - 236-2B 133 Appendix Item B COMMERCIAL ANALYTICAL CHEMICALS REPORT #367 To: r-rom: R. M. PAYFER - 236-2B subwl: E)ate: GLC ANALYSIS OF FM-3924 (T-2"9 RODENT CHOW (RIKEE Sept. 13, 1982 COC) BLENDED IMTO GROUND STUDY #0281 CROO12) Reference: Commercial Chemicals Analytical Laboratory Request #18608 Ten samples of FM-3924 (W.R. ETFOSE) blended into ground rat chow, along with four blank ground rat chow samples, were received from L. J. Sibinski on Aug. 16, 1982. All samples were analyzed in triplicate for FM-3924 with the following results: Sample 200 PPM Concentrate Blank for 200 PPM Blank for 100 PPM 100 PPM Top 100 PPM Middle 100 PPM Bottom Blank for 30 PPM 30 PPM Top 30 PPM Middle 30 PPM Bottom Blank for 10 PPM 10 PPM Top 10 PPM Middle 10 PPM Bottom Theoretical PPM 200 0 0 100 100 100 0 30 30 30 0 10 10 10 Actual PPM ug/g FM-3924 193 0 .1 0 >',->-F3 28 29 29 0 10 11 Rmpf-ce'r4qJ-"7 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-GB L. D. Winter - 236-2B 134 Appendix Item B Commercial Chemicals Analytical Report 0368 TO Frcr-. R. M. Payfer 236-28 &Ara Daie GLC Re-analysis of FM-3924 (T-2999CoC) blended into ground rat chow (Riker Study No. 0281 CROO12) September 14, 1982 Reference: Commercial Chemicals Analytical Request #18610 Laboratory Three samples of FM-3924 (W.R. Et-Fose) blended into ground rat chow, along with a blank ground rat chow sample, were received from L. J. Sibinski on August 27, 1982. These samples were analyzed in triplicate for FM-3924 with the following results. Actual PPM Sample Theoretical PPM ug/g FM-3924 Blank for 100 PPM 0 0 100 PPM top 100 PPM middle 100 105 100 100 100 PPM bottom 100 85 RMP:sk 135 Appendix Item B TO F:rofn G. W. Kirsch 236-2B Commercial Chemicals Analytical Report #383 Subject- GLC Analysis of FM-3924 (T-2999 CoC) Blended into Ground Rodent Chow (Riker Study #0281-CROO12) Date: December 8, 1982 3M Reference: Commercial Chemicals Analytical Laboratory Request #18854. Ten samples of FM-3924 (W.R. ETFOSE) blended into ground rat chow, along with four blank ground rat chow samples, were received from L. J. Sibinski on November 15, 1982. All samples were analyzed in trlpllcate-for FM-3924 with the following results: Sample 200 ppm Concentrate Blank for 200 ppm Blank for 100 ppm 100 ppm Top 100 ppm Middle 100 ppm Bottom Blank for 30 ppm 30 ppm Top 30 ppm Middle 30 ppm Bottom Blank for 10 ppm 10 ppm Top 10 ppm Middle 10 ppm Bottom Theoretical ppm 200 0 0 100 100 100 0 30 30 30 0 10 10 10 Actual ppm pg/g FM-3924 223 0 0 112 112 98 0 34 32 34 0 12 12 10 GWK:ch dc: M. T. Case - 218-2 E. G. Lamprecht - 218-3 J. D. LaZerts - 216-IL W. C. McCormick - 220-2E R. M. Payfer - 236-28 V. Prothapragada - 236-GB L. D. Winter - 236-2B 136 Appendix Item B CommercialChemicals Analytical Report #394 TO L. J. SIBINSKI 218-3 r-rom G. W. KIRSCH - 236-2B SLbtect [)Bic GLC ANALYSIS OF FM-3924 (T-2999 CoC) BLENDED INTO GROUND RODENT CHOW (RIKER STUDY #0281-CROO12) MARCH 1, 1983 Reference: Commercial Chemicals Analytical Laboratory Request #18854 Ten sariiplesof FM-3924 (W.R. ETFOSE) blended into ground rat chow, along with four blank ground rat chow samples, were received from L. J. Sibinski on February 16, 1983. All samples were analyzed in triplicate for FM-3924 with the following results: Sample Theoretical ppin Actual ppm u-g/g FM-3924 200 ppm Concentrate 200 Blank for 200 pprn 0 0 Blank for 100 ppm 0 0 100 ppin Top 100 92 100 ppm Middle 100 104 100 ppm Bottom 100 80 Blank for 30 ppm 0 0 pp..-T.op 30 7 30 ppm Middle 30 30 ppm Bottom 30 29 Blank for 10 ppm 0 0 10 ppm Top 10 9 10 ppm Middle 10 8 10 ppm Bottom 10 8 GWK/hc dc: M. T. Case - 218-2 E. G. Lamprecht - 218-3 J. D. LaZerte - 236-1 W. C. McCormick 220-2E R. M. Payfer - 236-2B W. H.-Pearlson - 223-6SE L. D. Winter - 236-28 137 Appendix Item B 'To. Frorn Subyect: Date: Commercial Chemicals Analytical Report 1403 G. W. KIRSCH 236-28 GLC ANALYSIS OF FM-3924 (T-2999 CoC) BLENDED INTO GROUND RODENT CHOW (RIKER STUDY #0281-CROO12) APRIL 19, 1983 Reference: Commercial Chemicals Analytical Laboratory Request #19332 Ten samples of FM-3924 (W.R. ETFOSE) blended into ground rat chow, along wit' h four blank ground rat chow samples, were received from L. J. Sibinski on April 13, 1983. All samples were analyzed in triplicate for FM-3924 with the following results: Sample Theoretical ppm Actual ppm ug/g FM-3924 200 ppm Concentrate 200 Blank for 200 ppm 0 Blank for 100 ppm 0 100 ppm Top 100 100 ppm Middle 100 100 ppm Bottom 100 Blank for 30 ppm 0 30 ppm Top 30 30 ppm Middle 30 30 ppm Bottom 30 Blank for 10 ppm 0 10 ppm Top 10 10 ppm Middle 10 10 ppm Bottom 10 207 0 0 ioi,, 99 + 103 0 31, 29 28 0 91, 9 8 GWK/hc dc: M. T. Case - 218-2 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 138 Appendix Item C Two Year oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Normal Ranges for Hematologic and Blood Chemistry Values of Rats at Riker Laboratories, Inc., St. Paul, MN Erythrocytes Hemoglobin Hematocrit Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Leukocytes Neutrophils 2-22% Lymphocytes 65-95% Monocytes 0-5% Eosinophils 0-64 Blood Urea Nitrogen (BUN) Glucose Total Bilirubin Total Protein Albumin Calcium Alanine Aminotransforas* (ALT) Aspartate Aminotransforane (AST) Alkaline Phosphatass Creatine Phosphokinase (CPK) 5,000,000-8,000,000 calls/cu mm 11-17 g/dl 36-52% 57-77 microng3 18-24 picograms 30-34% 6,000-15,000 calls/eu mm 500-4,000 calls/cu mm 5,000-14,000 colls/cu mm 0-500 colls/cu mm 0-500 cells/cu mm 10-30 mg/dl 120-160 mg/dl 0.1-1.0 mg/di 5.5-7.5 g/di 3.5-5.5 g/dl 10.2-12.5 mg/dl 10-40 International Units/i 20-60 International Units/i 50-200 International Units/i 50-150 International Units/1 139 Appendix Item C Methods Used for Hematology On Bleedings at 3 and 6 Months Parameters Units Methods Hematology Total Erythrocytes & Leukocytes Hemoglobin Hematocrit 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 1 4u' APPENDIX ITEM C METHODS USED FOR HEMATOLOGYDETERMINATIONSFOR 12, IS AND 24 MONTHS METHODS USED FOR CLINICAL CHEMISTRY DETERMINATIONS FOR 3, 6, 12, 18 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 6 cells(IO/mm 3 cells(lo3/mm3) g/dl % Y./100 WBC mg/dl g/dl International Units/1 Methods and Technioues UltraLogic 800 Hematology Analyzer Clay Adams, Division of Becton, Dickinson & Co. Microscope slide Rotochem 36 IIA Travenol Laborataories,lnc. TS Meter, AO Instrument Co. BiliLabstix Ames Company 141 APPENDIX--ITEM D PATHOLOGY REPORT OF RATS RECEIVING FLUOROCHENICAL FM-3924 IN DIET FOR TWO YEARS 142 METBODS 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 abdomen, thorax and cranium were examined in situ and after removal from the carcass. Representative tissues and organs from each rat were fixed in 10% buffered neutal formalin for subsequent histologic processing. At the 1 and 2 year sacrifices, wet weights were obtained on adrenals, brain, testes, heart, kidneys, liver, spleen and uterus from 15 randomly selected rats/sex/group. Body weights were obtained prior to necropsy from the same rats for calculation of relative organ weights. Histopathology 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 control group (0 ppm) and the 100 ppm group which were sacrificed at I and 2 years or which died or were sacrificed in extremis during the course of study. aorta adrenals (2) brain (3 sections including frontal cortex and basal ganglia, parietal cortex and thalamus; cerebellum and pons) eyes gonads ovaries (2) testes/epididymides (2) heart small intestine (3 sections) large intestine kidneys (2 sections) liver (2 sections) lung (2 sections) lymph node (mesenteric) 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 other gross lesions Microscopic examination of tissues from the 30 and 10 ppm groups included all the above listed tissues except aorta, brain, eyes, small and large intestine, lymph node and spinal cord/bone marrow. 0281CROO12 (FM-3924) 143 RESULTS Gross_Pathology At the 1 year interim sacrifice, an increased incidence of pale/tan color livers described in male rats from the 100 ppm group was considered possibly compound related. There were no necropsy findings suggestive of a compound effect in female rats from the 100 ppm group which were sacrificed at I year. In rats which were sacrificed at study termination or which died or were sacrificed in extremis during the course of study (TS/DOS), an increased incidence was noted for liver masses, nodules and raised lesions, mottled livers and yellow or pale liver foci and lecions at the 100 ppm level in males and females. No gross findings suggestive of a compound effect were seen in any TS/DOS rats from the 30 or 10 ppm groups. Other gross pathologic findings were typical of findings in ageing rats of this strain. These included mammary masses, pittiitary masses and foci, ulcers on the hind footpads, pale livers and pale, pitted and enlarged kidneys. Organ Weights There were several statistically significant (p 4 0.05) variations in absolute and relative organ weights (organ:body, organ:brain weight ratios) i!l male and females rats from the 100 ppm group which were sacrificed at I year. Increases in absolute liver weight and in liver:brair.weight ratios in males and l& oem4alesfrom the 100 ppm group correlated with compound related morphologic changes and were considered toxicologically significant. A significant decrease in group mean body weight in male and female rats from the 100 ppm group at 1 year also was considered toxicologically significant. None of the other organ weight variations in 100 ppm rats at the I year interim was considered of toxicologic significance. At the terminal sacrifice, statistically significant increases occurred in absolute liver weight and i-.ltiver:body and liver:brain weight ratios in males and females at the 100 ppm level. A significant increase in liver:body weight ratio also occurred in 30 ppm males and females. These increases in liver weight correlated with worphologic liver changes and were considered toxicologically significant. A statisticallysignificant decrease in body weight in males and females at 100 ppm also was considered toxicologically significant. No morphologic correlates were observed 'or other statistically significant organ weight variations and they were not considered toxicologically significant. 0281CROO12 (FM-3924) -2- 144 Histopathology Compound related microscopic changes were observed in the livers of male and female rats from the 100 ppm group at the 1 year interim sacrifice, in male and female TS/DOS rats from the 100 and 30 ppm groups and in male TS/DOS rats from the 10 ppm group. The principal compound related liver change was megalocytosis, which was characterized by an increase in size of liver parenchymal cells due to an increase in cytoplasmic volume. The increased cytoplasm was of a finely granular "ground glass" appearance. The coarser cytoplasmic organelles were relatively decreased and were displaced to the cell membrane. The nucleus:cytoplasm ratio was decreased by the increase in cytoplasmic volume in affected cells. Most or all lobules in affected livers were involved and the centrilobular cells were more severely affected. At the 1 year interim, megalocytosis occurred to a mild to marked degree in 15/15 males and to a minimal to moderate degree in 14/15 females from the 100 ppm group. The lesion was accompanied by mild to moderate hepatocyte vacuolation, probably fatty, in 14/15 males and by minimal to mild necrosis in 6/15. In females, minimal to mild hepatocyte vacuoldtion occurred in 5/15 controls and 15/15 100 ppm rats but necrosis was not seen. Association of hepatocyte vacuolation and necrosis with megalocytosis suggests that the progression of lesions is megalocytosis to fatty degeneration to necrosis. In TS/DOS rats, megalocytosis occurred in males from the 100, 30 and 10 ppm groups with a dose response evident in incidence and severity. In female TS/DOS rats, megalocytosis occurred only at the 100 and 30 ppm levels; the 10 ppm level was free of compound related microscopic lesions in females. The incidence of megalocytosis in TS/DOS males was 0/50, 42/50, 28/50 and 27/50 at the 0, 100, 30 and 10 ppm levels, respectively. In_females, the incidence was 44/50 and 1/50 at the 100 and 30 ppm levels. The incidence of megalocytosis was statistically significant in male rats at the 100, 30 and 10 ppm levels and in females at the 100 ppm level. Incidence and severity of hepatocyte vacuolation and necrosis also was increased in 100 ppm TS/DOS males; the increased incidence of these lesions was statistically significant at this level. Five hyperplastic nodules occurred in males at the 100 ppm level and 1 was seen at the 30 ppm level. Presence of hyperplastic nodules indicated regeneration was occurring in these livers. There were 9 hyperpladtic nodules in 100 ppm females and 1 in a control female; this increase was statistically significant. Cystoid degeneration, characterized by areas of multilocular microcysts in the liver parenchyma, 0281CROO12 (FM-3924) -3- 145 also was increased in male rats from the 100 and 30 ppm groups and in females from the 100 ppm group. Incidence of this lesion in males was 4/50, 15/50, 8/50 and 6/50 at 0, 100, 30 and 10 ppm, respectively. The increased incidence at the 100 ppm level was statistically significant. In females, the incidence of cystoid degeneration was 4/50 in the 100 ppm group and 0/50 in all other groups. Occurrence of these liver histomorphologic changes correlated with elevations in alkaline phosphatase, aspartate aminotransferase and alanine aminotransferase levels observed in 100 ppm male rats. The markedly reduced incidence and severity of histomorphologic liver changes in female rats parallels the absence of change 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 FM-3924 altered liver metabolism of endogenous steroids, were observed in the adrenals and ovaries. In the adrenals, a statistically significant increased incidence of nodular hyperplasia of the cortex occurred in males at the 100 ppm level. Incidence of this lesion was 2/49, 11/50, 0/49 and 5/50 at the 0, 100, 30 and 10 ppm levels, respectively. In females, there was a dose related occurrence of tubular hyperplasia of the ovarian stroma. Tubular hyperplasia is a non-neoplastic diffuse increase in tubular elements of the ovarian stroma which was usually bilateral and associated with absent or markedly reduced follicular development. The incidence of this condition, which was statistically significant at all dose levels, was 0/48, 15/48, 11/48 and 6/47 at the 0, 100, 30 and 10 ppm levels, respectively. An increased incidence of accumulations of foamy alveolar macrophages in the lung, which was probably compound related, was statistically significant in males and females at the 100 ppm level. The incidence of this condition at the 0, 100, 30 and 10 ppm levels, respectively, was 10/50, 23/50, 15/50 and 18/50 in males and 14/50, 27/50, 15/50 and 14/50 in females. There was no increased incidence of neoplasia suggestive of a compound effect in male rats. Incidence of primary liver tumors (hepatocellular carcinomas) in males was 3/50, 2/50, 1/50 and 1/50 at 0, 100, 30 and 10 ppm, respectively. In females, the only occurrence of primary liver tumors was at the 100 ppm level where there were 3 hepatocellular carcinomas and 4 hepatocellular adenomas. This increased incidence of these primary liver tumors in high dose female rats was not statistically significant. There was no other incidence of neoplasia 0281CROO12 (FM-3924) -4- 146 suggestive of a compound effect in female rats. Other microscopic lesions in tissues from FH-3924 treated rats were typical of naturally occurring inflammatory, degenerative and neoplastic leeions 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 triads of the liver which was frequently associated with portal bile duct proliferation and perivascular mononuclear inflammatory cell infiltrate and multifocal chronic interstitial pneumonia in the lung. There were a number of non-neoplastic lesions which, although they had a statistically significant variation in incidence compared to control group levels, were not considered to be of toxicological significance. These included decreased incidence of chronic myocarditis in 100 ppm females, decreased incidence of perivascular mononuclear cell infiltrate. in the lung of 100 ppm males, increased incidence of vascular mineralization in the lung of 100, 30 and 10 ppm females, decreased incidence of interstitial pneumonia in 10 ppm males, increased incidence of vascular mineralization in the testes of 10 ppm males and decreased incidence of epithelial hyperplasia of the urinary bladder epithelium of 10 ppm females. 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, iocal acinar atrophy in the pancreas and chronic progressive nephropathy. Pituitary adenomas were the most common neoplasm in male and female rats. Mammary adenocarcinomas and fibroadenomas also were frequently observed in 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. Q)Jge,Qj. Robert G. Geil, D.V.H. Diplomate, American College of Veterinary Pathologists .9 /-1 -7 Datd 0281CROO12 (FM-3924) 147 TABLE OF CONTENTS Table Number Page I Macroscopic Incidericefor @tales- I Year Interim.............1 .. 2 Macroscopic Incidence for Females - I Year Interim............ M3croscupic Incidence for Males .......................o.o...3.-.-, 4 M.-icroscclpiIcncideiicefor Females....... ...oo..o .............@.-c.z 5 !%-,in-:,ct)plasItniccidelice for Males - 1 Year Interim..........U.-.12 Xon-neoplastic I-icidencefor Females - 1 Year Interiri..,.. i Non-neoplasticInct-dencfeor Males. .......... Non-neoplastic Incideticefor Females .....oo .......o.o ......o...27-3,) y Neoplast4-c Incidence for Males - I Year Interim.....oo .....o....)7 11 Neoplastic Incidence for Females - 1 Year Interim............o.3'1 11 Ncoplastic Incidence for Males, .... o......o .............. 12 ',.enplastIincidencefor Femaics......................o .....4.1-,2 ,\T)?o.ndix r @a-M I Single TibtilatedAnimal Report - I Year Interim...............1-2@z 2 Sin-le Tabulated Animal Report.... .... oo.o.o ... o.o..o ........... Ti:;s-.ipI-ivetitory - 1 Year Ititeri.m...... ............ Ti-,siiIenvent@)rv...... ...................... .............2.q6-31- 0'-@OIIC,-@001(2F,%1-3924) 148 Macroscopic Incidence for Males Riker Laboratories,Inc. 3H FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats - one Year Interim Table 1 Project Number: 0231CROO12 Species: Rat Site/ Description Group 1 Group 2 No visible lesions Eye opacity atrophy Liver pale/tan cqlor Nesentary fat necrosis Kidney hydronephrosis cystic lesion Skin hair loss Soft Tissue (thorax) mass Soft Tissue(leg) swollen foot 9 7 1 I 2 6 1 I 1 Titles: Group I Group 2 CONTROL FM-39@14 0 ppo 100 ppm Macroscopic Incidence Page: I 149 Macroscopic Incidence for Females Riker Laboratories,Inc. 3H FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats - One Year Interim Table: 2 Project Number: 0281CROOIZ Species: Rat Site/ Description No visible lesions Eye atrophy Pituitary enlarged Adrenal enlarged Liver pale/tan* herniated lobe Mesentary mass Kidney hydronephrosis Uterus cystic lesion enlarged dilated,fluidfilled Mammary Gland mass Skin hair loss r,iass Group 1 Group 2 5 9 I 3 1 1 1 1 I I I I I 1 1 2 1 I Titles: Group I Group 2 CONTROL FN-3924 0 ppm 100 ppm includes *possibly" Macroscopic Incidence Page: 2 150 Macroscopic Incidence for Nales Riker Laboratories,Inc. 3H FN-3924: Two Year Oral Toxicity-OncogenicityStudy In Rats Table 3 Project Number: 0281CRD012 Species: Rat Site/ Description No visible lesions Brain dark area Eye opacity/cloudy ulcer/lesion atropny Pituitary nass/enlarged/raisedlesion dark/hemorrhagic/red foci Thyroid nlarged* Adren:i enlarged/mass cyst Throax (internal) fluidfilled Thymus enlarged* hemorrhagic/hemorrhagic lesion Lung mottled frothy tracheal exudate consolidation* mass/raised lesion hyperemic Heart flaccid/flabbly enlarged* pale Abdown (internal) gas, gastrointestinaltract stomach empty of food m-3ss, omentum fluidfilled Esophagus Stomacehnlarged;thickenedwall edem/thickened wall enlarged rugae erosions/ulcerations* small Intestine mass hemorrh&ge Group 1 Group 2 Group 3 Group 4 11 7 8 16 1 1 1 1 2 2 1 1 7 13 is 10 4 4 3 1 1 3 1 1 2 3 3 3 I 1 1 I I I 1 1 I I I 1 I 1 1 1 I 1 1 I I I I I I 1 1 1 1 1 I Titles: Group 1 Group 2 Group 3 Group 4 CONTROL FN-3924 FM-3924 FN-3924 0 ppm 100 ppo 30 ppm 10 ppo includes upossiblym Macroscopic Incidence Page: 3 151 Macroscopic Incidence for Males Riker Laboratories,Inc. 3M FN-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Table 3 Project Number: 0281CROO12 Species: Rat Site/ Description Large Intestine hemorrhagic Pancreas mass/nodule Liver pale/pale lobes* mass/nodult/raisedlesion mottled* yellow/pale foci/lesion enlarged infarct dark lesion shrunken lobes irregular surface Spleen enlarged raised lesion pale foci pale, depressed area dark small* Lymph node (mesenI.eric/abdominal) enlarged he,iorrhagic mass Mesentery nodular/enlarged/thickenedvessels bloody cystic lesion Kid.iey enlarged,pale, pitted pale, pitted pitted/rough surface pale, enlarged* pale pale are3 hydronephrosis,pelvic dilatation cystic/polycystic ulcerated area mass Group I Group 2 Group 3 Group 4 2 1 10 6 4 5 3 6 2 1 9 1 3 1 8 1 1 3 1 1 1 I 3 3 2 1 1 2 2 I 1 2 1 2 2 2 1 1 1 3 2 2 1 I 1 1 2 3 3 1 3 2 1 I 1 3 2 I 2 Titles: Group 1 Group 2 Group 3 Group 4 CONTROL FM-3924 FM-3924 FM-3924 0 ppm 100 ppm 30 ppm 10 ppo includes "possiblyn Macroscopic Incidence Page: 4 152 MacroscopicIncidence for Males Riker Laboratories.Inc. 3M FM-3924:Two Year Oral Toxicity-OncogenicityStudy in Rats Table 3 Project Number: CelulCROO12 Species: Rat Site/ Description Urinary Bladder distended hematuria/fillewdith reddish/darkfluid hemorrhagicwall calculi Testis/Epididymis small enlarged* Prostate enlarged/thickened/mass edematous small Ma.mary Gland mass Skin ulcers/inflamed/circular/raised lesions,hind footpads dermatitis/ulcer/lesion/ inflamed area* moist area hair loss mass/thickening abscess Soft Tissue (neck) mass Soft Tissue(thorax) inass Soft Tissue(leg) swollen paws/feet Bone swollenjoints Group I Group 2 Group 3 Group 4 1 2 I 1 1 4 3 5 3 1 1 1 1 1 1 1 1 7 4 3 5 1 3 1 1 1 1 4 4 1 2 1 2 I 1 1 1 1 Titles: Group I Group 2 Group 3 Group 4 CONTROL FM-3924 FM-3924 FM-3924 0 ppm 100 ppm 30 ppm 10 ppm includes"possibly" MacroscopicIncidencePage: 5 153 Macroscopic Incidence for Females Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-oncogenicityStudy in Rats Table 4 Project flumber:0281CROO12 Species: Rat Site/ Description No visible lesions Eye opacity/cloudy infIammati on atrophy Pituitary mass/enlarged/raised lesion henorrhagic/dar'.l,esion cyst Thyroid enlarged Adronal enlarged mass/raised lesion pale Thor3x (internal) fluid filled mass Thyr,r.is enlarged Lung mottled consolidation nodule pale hemorrhagic filledwith red fluid Lymph Node (bronchial) enlarged Heart pericarditis* Stomach ulcerations/erosions enlarged rugae red mucosal areas/reddened blackish,yellowish fluid contents Small Intestine inflamed thickened walls Large Intestine impaction mass Group I Group 2 Group 3 Group 4 4 6 4 4 3 2 1 1 1 1 25 23 30 33 1 1 1 1 8 3 3 5 4 1 1 1 I 1 1 2 1 I 1 1 1 1 1 1 1 1 2 1 1 Titles: Group I Group 2 Group 3 Group 4 CONTROL FM-3924 FM-3924 FM-3924 0 ppm 100 ppm 33 ppm 10 ppm includes "possibly" Macroscopic Incidence Page: 6 154 macroscopic Incidence for Females Riker Laboratories.Inc. 3M FM-3924: Two Year Oral Toxicity-oncogenicityStudy in Rats Table 4 Project Number: 0281CROO12 Species: Rat Site/ Description Group I Group 2 Group 3 Group 4 Pancreas mass/nodule Liver pale* mass/nodule/raised lesion mottled circular lesion/palefoci/palelesion/ yellotiishlesion enlarged* dark red area/lobe rough/irregularsurface dark color/dark brown Spleen enlarged small Lymph node (mesenteric/abdominal) enlarged reddened Kidney enlarged.pale, pitted enlarged* pale, pitted pitted mottled cyst congenital absence, left Urinary Bladder enlarged calculi mass thickened walls Ovary mass cyst Uterus enlarged filled with dark/bloodyfluid mass cystic lesion dark area/lesion prolapsed congenital absence of left horn. ovary Vagina mass Titles: Group I Group 2 Group 3 Group 4 CONTROL F14-3924 FM-3924 FM-3924 0 ppm 100 ppm 30 ppm 10 ppm 1 1 10 6 8 10, 2 8 1 4 9 2 3 9 1 3 2 1 1 1 I 1 2 2 5 2 2 2 1 1 2 1 1 1 1 1 2 2 1 1 1 3 2 1 1 1 1 1 1 1 2 2 1 2 1 I I 2 2 I 3 I includes *possiblyn Macroscopic Incidence Page: 7 155 Macroscopic Incidence for Females Riker Laboratories,Inc. 3H FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Table 4 Project Number: 0281CROO12 Species: Rat Site/ Description Group I Group 2 Group 3 Group I Mammary Gland mass/nodule milk cyst Skin raised/inflamed/ulceratedlesion, footpad mass raised lesion hair loss/thinning circular lesion Soft Tissues (nec't-.) reddened. gland-likestructures Soft Tissues(leg) swollen foot mass 27 14 24 19 1 2 2 1 1 1 2 2 4 1 2 1 2 3 1 I I 1 Titles: Group 1 Group 2 Group 3 Group 4 CONTROL FM-3924 FK-3924 P4-3924 0 ppm 100 ppm 30 ppm 10 ppm Macroscopic Incidence Page: 8 156 Non-Neoplastic Incidence for Males Riker Laboratories,Inc. 3M FM-3S24: Two Year Oral Toxicity-Oncogenicity Study in Rats - One Year Interim Table: 5 Project Number: 0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Adrenal Within normal limits Cortical vacuolation mild Nodular hyperplasia, cortex moderate Sinusoidalectasia, cortex Aorta moderate Within normal limits Bone Marrow Within normal limits Brain Within normal limits Esophagus Within normal limits Eye Within normal limits Keratitis,acute marked Heart Within normal limits Myocarditis, chronic nonsuppurative mild Kidney Within normal limits Calculus Chronic progressive nephropathy minimal mild Cyst Hydronephrosis moderate Nephritis,interstitial,chronic mild Pyelitis,acute minimal Large Intestine Within normal limits Liver Within normal limits Group 1 Group 2 ----------------------- 15) 15) 12 is 1 0 1 0 1 0 1 0 1 0 1 0 15) 15) 15 is 14) 15) 14 is 15) 15) is is 15) 15) 15 15 15) 15) is 14 0 1 0 1 15) 15) 14 15 1 0 1 0 15) 15) 5 7 1 0 8 8 5 6 3 2 1 0 1 0 1 0 1 0 1 0 1 0 1 0 15) 14) 15 14 15) 15) 7 0 Titles: Group 1 CONTROL 0 pp:n Group 2 FM-3924 100 ppm Total Examined 15 7 Microscopic Incidence Page: 9 Non-NeoplasticIncidence for Males (continued) Riker Laboratories,Inc. 3M FN-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats - One Year Interim Table: 5 Project Number: 0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Liver (continued) Hepatocyte alteration, vacuolated minimal mild Hepatocyte vacuolation mild' ' moderate Megal ocytosi s mild moderate marked Necrosis minimal nild Portal bile duct proliferation minimal mild Portal mononuclearcell infiltrate minimal mild Lung -Within normal limits Alveolar nacrophages mild Atelectasis mild Hemorrhage mild moderate marked Hyperplasia, septal cell mild Perivascular mononuclear infiltrate minimal mild Pneumonia, interstitial,chronic minimal mild Vascular mineralization minimal mild Group I Group 2 ---------------------- 2 0 1 0 1 0 0 14 0 8 0 6 0 is 0 5 0 s 0 s 0 6 0 1 0 5 5 8 1 2 4 6 7 14 1 1 6 13 15) 15) I I 3 3 3 3 1 1 1 1 6 6 6 3 0 2 0 1 1 0 1 0 2 5 0 1 2 4 3 3 1 0 2 3 7 9 4 1 3 8 Titles: Group I CDNTROL 0 ppm Group 2 F14-3924 100 ppm Total Examined Microscopic Incidence Page: 10 158 Non-Meoplastic Incidence for 14ales(continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats - One Year Interim Table: 5 Project Number: 0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Lymph Node (mesenteric) Within normal limits Hemorrhage mild Hemosiderosis mild' Mammary Gland Within normal limits Mesentery Necrosis, fat marked Steatitis,chronic moderate Pancreas Within normal limits Acinar atrophy mild moderate Pancreatitis,chronic mild Parathyroid Within normal limits Pituitary Wi-6hin normal limits cyst Prostate Within normal limits Salivary Gland Within normal limits Small Intestine Within normal limits Spinal Cord Within normal limits Spleen wi thin normal limits Hemosiderosis mild Stomach Within normal limits Testis/Epididymis Within normal limits Group I Group 2 ---------------------- 13) 13 0 0 0 0 3) 3 1) 1 1 1 1 15) 11 3 2 1 3 3 ( 7) 7 (14) 13 1 15) is is) is 15) 15 14) 14 (15) is 0 0 (14) 14 (15) 15 14) 13 1 1 1 1 1) 0 0) 0 0 0 0 14) 14 0 0 0 0 0 5) 5 13) 11 1 15) is 13) 13 15) is (14) 14 (15) 14 1 1 (14) 14 (15) 13 Titles: Group 1 CONTROL 0 ppm Group 2 FM-3924 100 ppm Total Examined Microscopic Incidence Page: 11 159 Non-Neoplastic Incidence for @iales(continued) Riker Laboratories,Inc. 3M FM-3924: Ti4oYear Oral Toxicity-OncogenicityStudy in Rats - One Year Interim Table: 5 Project Number: 02'VlCROO12 Species: Rat Tissue/ Diagnosis/ Modifier Testis/Epididymis(continued) Tubule atrophy, aspermatogenesis mild VaSCU13r mi.-ieralization mild Thyroid Within norinallimits Follicularhyperplasia,cystic moderate Trachea Within nor-,iallimits Urinary Bladder Within ;iormallimits Group 1 Group 2 ---------------------- 0 1 0 1 0 1 0 1 11) ( 12) 11 11 0 1 0 1 15) (15) 15 15 15) (14) is 14 Til6les: Group Group 1 CONTROL 0 ppm 2 FM-14924 100 ppm Total Examined 160 Microscopic Incidence Page: 12 Non-Neoplastic Incidence for Females-Riker Laboratories, Inc. 3M FM-3924: 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 Sinusoidal ectasia, cortex nild marked Aorta Within nornal limits Bone Marrow Within normal limits Brain Within normal limits Esophagus Within normal limits Eye Within normal liiits Atrophy marked Pa.iophthalmitis marked Heart Within iiormsllimits @lyocarditis,chronic nonsuppirative minimal Kidney Within nor-nallimits Calculus mild moderate Chronic progressive nephropathy mild Cyst mild Hydronephrosis moderate Hyperplasia.pelvic epithelium mild Pelvic mineralization minimal mild moderate Group I Group 2 ---------------------- 15) 15) 10 13 2 1 2 1 4 1 3 1 1 0 14) 15) 14 is 15) 15) 15 is 15) 15) is is (15) 111) 15 12 (15) 15) 14 is 1 1 0 1 0 1 0 15) 15) 14 15 1 0 1 0 15) 15) 6 12 4 1 1 0 1 0 1 1 2 1 0 1 0 1 0 1 0 1 0 1 0 4 2 4 0 0 1 0 1 Titles: Group 1 CO.IJTRDL0 ppm Group 2 FM-3924 100 ppm Total Examined 161 Microscopic Incidence Page: 13 Non-NeoplasticIncidencefor Females (continued) Riker Laboratories,Inc. 3M Ft4-3924:Two Year Oral Toxicity-OncogenicityStudy in Rats - One Year Interim Table: 6 Project flumber:0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Large Intestine Within normal li.-nits Nematodiasis Liver Within normal limits Hepatocyte alteration. vacuolated mild Hepatocyte vacuolation minimal mild Megal ocytosi s minimal mild moderate Pigment, Kupfer cell mild Portal bile duct proliferation mild Portalmononuclearcell infiltrate mi niilal mild Tel angiectasis moderate Lung Within normal limits Alveolar macrophages mild Bro.nchiectasis mild Hemorrhage mild moderate Perivascularmononuclear infiltrate mild Pneumonia, interstitial,chronic mild Vascular mineraliza6ion mild Lymph Node (roesenteric) Within normal limits Group 1 Group 2 ---------------------- 14) 13) 12 14 2 1 15) 15) 6 0 1 0 1 0 5 is 3 7 2 8 0 14 0 4 0 7 0 3 0 1 0 1 2 3 2 3 2 1 0 1 3 0 1 0 1 15) 15) 3 1 1 3 1 3 0 1 0 1 11 10 9 7 2 3 1 3 1 3 1 2 1 2 1 3 1 3 12) 14) 12 14 Titles: Group I CONTROL 0 ppm Group 2 FM-3924 100 ppm Total Examined 16 2 Microscopic Incidence Page: 14 Non-NeoplasticIncidencefor Females(continued) Riker Laboratories,Inc. 3H FM-.1,92T4w:o Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table: 6 Project N=ber: 0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Mammary Gland Within normal limits Galactocele Mesentery Necrosis, fat moderate Steatitis,chronic moderate Ovary Within normal limits Cyst Pancreas Within normal limits Pancreatitis,chronic mild Parathyroid Within normal limits Pituitary Within normal limits Salivary Gland Within normal limits Skin Within normal limits Small Intestine Within norm-31limits Spinal Cord Within normal limits Spl ee.-i Within normal limits Hemosiderasis mild Stomach moderate Within normal limits Thyroid Within nornal limits Trachea Within normal limits Urinary Bladder Within normal limits Group I Group 2 ---------------------- 15) 13 2 1) 1 1 1 1 15) 14 1 15) 14 1 1 6) 6 15) 14 15) is 2) 2 15) is (14) 14 (15) 14 1 1 0 (15) 15 (14) 14 (15) 15 (12) 12 15) 13 1 1) 1 1 1 1 14) 14 0 15) 15 0 0 4) 4 (15) 13 (14) 14 1) 1 is) is 15) is 15) 12 3 2 1 15) 15 13) 13 14) 14 14) 14 Titles: Group 1 CONTROL 0 ppm Group 2 FM-3924 100 ppn Total Examined 163 Microscopic Incidence Page: 15 Non-NeoplasticIncidence for Females (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year oral Toxicity-Oncogenicity Study i-,Riats - One Year Interim Table: 6 ,Project Number: 0231CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Uterus Within normal limits Cystic glands marked Endometritis, chronic mild Hydr3metra moderate Hyperplasia, glandular epithelium mild moderate Metaplasia, squanous minimal mild moderate Group 1 Group 2 ---------------------- 15) is) 12 7 1 0 1 0 0 1 0 1 0 2 0 2 2 1 2 0 0 1 2 6 3 1 2 4 0 1 Titles: Group 1 CONTROL 0 ppm Group 2 FM-3924 100 ppm Total Examined 16 4 Microscopic Incidence Page: 15 Non-Neoplastic Incidence for Kales Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0281CROOll. Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Adrenal Within normal limits Atrophy mild marked Cortical degeneration mild Cortical vacuolation mini-nal mild moderate Hemorrhage marked Medullary cell hyperplasia minimal mild moderate marked Nodular hyperplasia,cortex minimal mild moderate marked Sinusoidalectasia, cortex minimal nild moderate marked Aorta Within normal limits Mineralizatioi mild Necrosis moderate Bone Arthritis,synovitis;joints mild moderate marked Bone ?4arrow Within normal limits Group 1 Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 15) 34) 6 13 0 0 0 0 0 0 0 0 0 0 7 17 0 2 4 13 3 2 0 0 0 0 2 6 0 0 1 4 1 2 0 0 0 2 0 0 0 1 0 1 0 0 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 0 0 0 0 0 2 15) 32) 15 32 19) 31) 9 10 1 1 1 0 0 1 0 0 0 0 6 12 1 1 5 5 0 6 0 1 0 1 0 3 0 In. 0 2 0 0 0 1 4 7 1 1 3 3 0 2 0 0 5 10 1 3 4 4 0 3 0 0 15) 31) is 31 0 0 0 0 0 0 0 0 ( 1) ( 1) 0 1 0 0 0 1 0 0 ( 19) ( 31) 19 31 14) 35) 4 8 0 0 0 0 0 0 0 2 0 2 3 J-) 0 1 2 8 1 3 0 0 3 0 0 5 0 1 3 3 0 1 0 0 0 0 0 0 0 0 0 0 0 0 7 13 0 0 4 3 1 4 2 1 0) ( 0) 0 0 0 0 0 0 0 0 0 0 0) 0) 0 0 0 0 0 0 0 0 0) 0) 0 0 12) 3?) 7 19 0 0 0 0 0 0 0 4 0 4 1 9 0 0 1 8 0 1 0 0 0 0 1 1 0 0 1 0 0 0 0 0 0 5 0 0 0 3 u 1 0 1 3 2 0 0 3 1 1) 1 0 0 ','() 0) 0 0 0 0 0 0 0 0 0 1) 3) 1 1) 1 0 0 u 0 0 0) 0) 0 0 Titles: Group 1 CONTROL 0 ppm Group 2 FM-3924 100 ppm Group 3 FM-39&14 30 ppm Group 4 FM-3924 10 ppm Total Examined DOS- Unscheduled Death(s) SAC- Protoco'.Scheduled Sacrifice(s) 16 5 Microscopic Incidence Page: 17 Non-Meoplastic Incidence for Males (continued) Riker Laboratories,Inc. 3M FM-3924: TvioYear Oral Toxicity-OncogenicityStudy in Rats Project Nunber: 0261CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Brain Within normal limits Abs.@ess mild Hemorrhage moderate Esophagus Withiiinormal limits Eye Within nor-.,ilailmits Cataract Keratitis,acute narked Keratitis,chronic mild marked Panophthalmitis marked Phthsis bulbi marked Retinal atrophy Heart mild Within normal limits Endocarditis, chronic moderate Epicarditis,chronic mild Myocardial fibrosis minimal mild moderate Myocarditis, chronic nonsuppurative minimal mild moderate Kidney Within normal limits Calculus mi niqal moderate marked Group 1 Group 2 Group Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 16) 34) 14 33 1 0 1 0 1 0 1 0 15) 33) 15 33 12) 33) 12 32 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 15) 34) 8 23 0 0 0 0 0 0 0 0 3 2 0 3 3 2 0 0 4 10 0 2 4 7 0 1 16) 34) 4 0 0 1 0 1 0 0 0 0 13) 31) 17 30 0 0 0 0 0 0 0 0 17) 28) 17 28 17) 31) 14 29 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 2 2 0 1 0 0 0 0 0 19) 31) 12 19 0 0 0 0 0 0 0 0 1 4 0 0 1 4 0 0 5 1.0 1 2 4 8 0 0 13) 31) 1 0 1 0 0 0 0 0 0 0 0) 0) 0 0 0 0 0 0 0 0 0 0 9) 15) 9 is 1) 1) 0 1 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 1-) 0 0 0 0 0 0 0 0 15) 35) 3 11 0 0 0 0 0 0 0 0 1 5 0 2 1 2 0 1 5 2AV 0 0 4 19 1 1 15) 35) 3 4 0 6 0 0 0 2 0 2 0) 0) 0 0 0 0 0 3 0 0 0 0 9) 36) 0 36 1) 4) 0 1 0 1 0 0 0 0 1 1 1 0 0 1 0 0 0 0 0 0 0 a 0 1 0 1 12) 3,@1) 9 15 0 1 0 1 1 0 1 3 1 9 0 1 6 0 3 2 v 0 1 2 16 0 1 12) 3,.>) 1 3 0 2 0 0 0 0 0 0 Titles: Group 1 CONTROL 0 ppn Group 2 FM-3924 100 ppin Group 3 FM-3924 30 ppm uroup 4 FM-3924 10 ppn Total Examined DOS- Unscheduled Beath(s) SACs Protocol Scheduled Sacrifice(s) 166 Microscopic Incidence Page: 18 Non-Neoplasticincidence for Males (continued) Riker Laboratories, Inc. 3M FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats Project liumber:0281CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Kidney (continued) Chronic progressive nephropathy minimal mil4 moderate marked Cyst moderate marked Hydronephrosis mild moderate Hyperplasia,pelvic epithelium mild Mineralization mild Nephrosis moderate Papillary necrosis modzrate Pelvic mineralization minimal mild moderate Pigment, conv. tub. epithelium mod,,rate Protein resorption droplets mild marked Pyelitis, acute minimal mild moderate Pyelonephritis, acute mild moderate Large Intestine Within normal limits Nematodiasis Liver Within normal limits Group I Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAl.' 10 34 12 31 11 29 10 34 1 4 4 5 1 7 2 6 5 16 8 15 6 14 7 19 2 11 0 6 0 7 1 5 2 3 0 4 4 1 0 4 1 3 0 0 0 0 1 1 0 1 0 0 0 0 0 0 1 2 0 0 0 0 0 0 1 2 3 1 0 0 0 2 1 0 0 0 0 0 0 0 0 2 3 1 0 0 0 0 0 0 1 0 0 0 1 1 0 0 1 0 0 0 1 1 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 1 0 2 0 a ol 0 0 1 0 2 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 3 0 0 0 3 2 6 0 1 0 0 0 2 0 1) 1 2 0 0 0 4 2 6 0 0 0 0 0 2 0 1 0 0 1 0 0 0 0 0 0 0 o 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 2 0 2 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 1 0 0 0 0 0 1 0 0 1 0 2 2 0 1 0 0 1 0 0 1 0 0 0 0 0 0 2 1 0 1 0 0 f 14)( 34) ( 17)( 31) ( 0) ( 1) ( 0) ( 0) 14 20 17 27 0 1 0 0 0 6 0 4 0 0 0 D (16)( 34) ( 19)( 31) ( 15)( 35) ( 12)( 3z,) 2 0 0 11 0 2 3 0 Titles: Group 1 COIITROL 0 p;xn Group 2 FM-3924 100 ppm Group 3 FM-3924 30 ppm Group 4 FM-3924 10 p;xn Total Examined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 16 7 Microscopic Incidence Page: 19 Non-NeoplasticIncidence for Males (continued) Riker Laboratories,Inc. 3H FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project flumb.-rO:2ClCROO12 Species: Rat Table; 7 Tissue/ Diagnosis/ Modifier Liver (continued) Atrophy marked Cystoid degeneration minimal mild moderate Fibrosis mild marked H ematopoiesis, extramedullary mild Hepatocyte alteration,basophilic mild moderate Hepatocyte alteration, vacuolated mininal -mild moderate Hepatocyte vacuolation minimal mild moderate marked Hyperplastic nodule Megalocytosis minimal mild moderate marved Mitotic activity,increased mild Necrosis minimal mild moderate marked Pigment minimal mild Portal bile duct proliferation minimal Group I Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 0 0 0 0 0 4 0 1 0 2 0 1 0 0 0 0 0 0 0 0 0 0 0 2 0 1 0 1 1 9 0 3 1 7 0 2 8 14 0 1 4 13 2 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 1 0 0 1 0 1 1 0 0 0 0 0 0 0 0 6 21 0 0 0 0 0 0 2 13 3 2 2 10 0 1 0 0 0 0 0 0 1 0 1 0 0 3 0 1 0 2 0 9 0 0 0 6 0 3 15 24 0 1 9 2 3 14 3 1 0 5 14 28 2 1 4 10 5 10 3 7 0 0 0 0 7 3 0 1 3 2 2 0 2 0 1 2 0 1 1 1 8 21 2 0 0 0 0 0 1 7 0 0 1 7 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 3 0 0 3 13 0 0 3 9 0 4 7 12 0 1 6 7 1 4 0 0 0 1 4 24 3 12 1 3 0 4 3 0 0 0 0 0 0 0 u 0 0 0 0 0 0 0 0 0 0 0 0 0 5 16 1 3 1 0 1 0 1 5 0 1 1 4 0 0 1 1 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 12 0 1 0 10 0 1 3 9 0 2 2 5 1 0 0 1 0 0 1 26 1 21 0 5 0 0 0 0 1 0 1 0 0 2 0 1 0 1 0 0 0 0 0 0 0 0 0 0 3 26 1 1 Titles: Group 1 CONTROL 0 ppm Group 2 FM-3924 100 ppm Group 3 FM-3924 33 ppm Group 4 FM-3924 10 ppm Total Examined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 16 8 Microscopic Incidence Page: 20 Mon-MeoplasticIncidence for Males (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0281CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Liver (continued) Portal bile duct proliferation mild moderate Portalmononuclearcell infiltrate minimal mild ,moderate Telangiectasis mild Lung Within normal limits Alveolar macrophages minimal mild moderate Atelectasis marked Edema mild moderate marked Fibrosis mild Granuloma n.ild Hemorrhage mild moderate marked Hyperplasia,septal cell mild moderate Mineralization mild !Iecrosis marked Peribronchial lymphoid hyperplasia mild Perivascularmononuclear infiltrate minimal mild Group I Group 2 Group *3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 5 21 1 0 7 30 0 2 7 28 0 0 0 0 0 0 16) 34) 0 1 5 5 1 2 4 2 0 1 0 0 0 0 3 0 1 0 1 0 1 0 1 0 1 0 0 0 0 0 6 4 2 1 1 2 3 1 0 0 0 0 0 0 0 0 0 0 1 0 1 3 0 1 0 1 2 19 0 2 14 6 21 0 0 7 23 1 0 6 23 0 0 0 0 0 0 19) 31) 0 0 6 17 0 0 6 16 D 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 10 6 7 2 3 3 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 6 0 0 1 6 3 13 1 0 9 20 1 5 7 15 1 0 1 0 1 0 15) 35) 1 3 5 10 0 0 5 8 0 2 0 0 0 0 0 '0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 4 10 1 5 3 4 0 1 0 2 0 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 6 14 0 1 6 12 2 25 0 0 6 35 1 2 4 33 1 0 0 0 0 0 12) 38) 0 1 2 16 0 2 15 0 1 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 2 6 1 3 1 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 14 0 0 1 14 Titles: Group 1 Group 2 Group 3 Group 4 CONTROL FM-3924 FM-3924 FM-3924 0 plxn 100 ppm 30 ppm 10 ppm Total Examined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 16 9 Microscopic Incidence Page: 21 Non-HeoplasticIncidence for Males (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0281CR3011- Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Lung (continued) Perivascularmononuclear infiltrate moder3te Pneumonia, foreign body moderate Pneumonia, interstitial,chronic minimal mild moderate Thrombus Vascular mineralization minimal mild moderate Lymph tiode Sinusoidal ectasia Moderate Lymph Node (abdominal) Hemorrhage .iiId Sinusoldal ectasia mar@ed Lymph 4ode (mesenteric) Within normal li,-ii@6s Hemorrhage minimal n,ild modarate Pir,,ent mild Siriusoidalectasia moderate Mesentary Cyst Polyarteritis marked Pancreas Within normal limits Acinar atrophy minimal mild moderate Group 1 Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 0 3 0 0 0 0 2 14 0 0 1 11 1 3 1 0 10 33 0 2 10 31 0 0 0) 0) 0 0 0 0 0) 0) 0 0 0 0 0 3 0 0 12) 33) 10 29 2 4 1 2 0 0 0 0 0 0 0 0 0 0) 2) 0 0 0 2 0 13) 33) 10 24 2 4 0 0 1 2 1 1 0 0 0 0 0 0 0 5 0 1 0 5 u 0 0 0 17 31 0 1 17 29 0 1 0) 0) 0 0 0 0 0) 0) 0 0 0 0 0 0 3 0 13) 29) 1'w' 25 2 3 0 2 1 1 0 1 0 1 1 0 1 0 0) 1) 0 1 0 0 0 0 1.1,) 29) 11 21 3 5 1 0 0 3 2 1 0 1 0 0 0 0 2 5 0 0 2 5 0 0 0 0 13 31 0 1 12 29 0 1 0) 0) 0 0 0 0 0) 1) 0 1 0 1 0 1 0 1 1) 1) 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 ( 1)( 0) 0 0 1 0 1 0 14) 35) 7 26 4 4 1 0 2 2 1 2 0 3 1 0 1 0 0 4 0 0 :It 4 3 0 0 0 11 34 1 7 10 27 0 0 0) 1) 0 1 0 1 0) 0) 0 0 0 0 0 0 0 0 0) 1) 3 0 0 0 0 0 0 0 0 0 0 0 0 0 rk 0 0 3) 0) 0 0 0 0 0 0 11) 37) 10 20, 1 6 1 0 0 5 0 1 Titles: aroup 1 Group 2 Group 3 Group 4 CONTROL FM-3924 FM-3924 FM-3924 0 pp-,3 100 ppm 30 ppm 10 ppm Total Exa-nined DOS= Unscheduled Death(s) SACs Protocol Scheduled Sacrifice(s) 17 0 Microscopic Incidence Page: 22 14on-NeoplastiIcncidencefor Males (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0231CRO312 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Pancreas (continued) Acinar atrophy marked Hyperplasia,acinar cell moderate Hyperplasia,islet cell mild moderate Pancreatitis,chronic marked Polyart,?ritis mild moderate marked Parathyroid Within normal limits Fibrosis moderate Hyperplasia mild moderate marked Pituitary Within normal limits cyst Hyperplasia mild Preputial Glaiid Preputial adenitis,acute moderat@. marked Prostate Within normal linits Edema moderate Hyperplasia moderate Prostatitis, acute minimal mild moderate marked Group 1 Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 0 1 0 0 0 0 0 2 0 0 0 2 0 D 0 0 0 4 0 a 0 2 0 2 6) 1G) 6 16 0 0 0 0 0 0 0 0 0 0 0 0 15) 33) 7 18 2 2 0 2 0 2 0) 0) 0 0 0 0 0 0 13) 33) 10 27 1 0 1 0 0 0 3 0 3 13 0 0 1 2 1 3 1 1 0 1 0 0 0 0 0 3 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 13) 16) 12 13 0 0 0 0 1 2 1 1 0 1 0 0 17) 30) 13 12 0 2 0 0 0 0 1) 3) 1 0 0 0 1 0 15) 31) 13 2-D u 0 3 0 0 1 0 1 2 1 0 1 1 0 0 0 1 0 3 0 0 0 0 1 2 0 0 1 2 0 1 0 1 1 0 1 0 0 0 0 0 9) 18) & 17 1 0 1 0 2 1) 0 0 1 0 1 0 15) 33) 4 14 0 1 0 0 0 0 0) 1) 0 1 0 1 0 0 12) 35) 9 25 0 0 0 0 0 0 0 3 8 0 1 1 1 1 3 1 3 0 0 0 1 0 1 0 0 0 0 0 0 0 0 3 0 0 2 0 0 0 2 0 0 9) 26) 9 2,j' 0 0 0 0 0 1 0 3 0 0 0 I, 11) 35) 4 13 1 2 0 2 0 2 0) 0) 0 3 0 0 0 0 11) 3@) 9 34 0 L) 0 ci 2 0 2 2 2 0 0 0 1 0 1 2 0 Titles: Group I CDNTROL 3 ppn Group 2 FM-3924 103 ppm Group 3 FM-3924 30 ppm Group 4 FM-3924 10 ppm Total Examined DOS= Unscheduled Death(s) SACZ Protocol Scheduled Sacrifice(s) 17 1 Microscopic Incidence Page: 23 Non-NeoplasticIncidencefor Males (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0231CRU012 Species: Rat Table: 7 Tissue/ Diagnosis/ i4odifier Group 1 Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC Prostate (continued) Prostatitis,chronic marked Salivary Gland Within normal linits Atrophy Sialadenitis,chronic minimal Skin Atrophy r.ioderate Cyst, dermal inclusion Dermatitis, chronic nild Pododer,iatitisu,lcerative marked ,,IJlcer marked S-iallIntestine .Withinnornal limits Polyar@6eritis moderate mar'.,ed SpiniilC:)rd Wi*lhi,-niornal limits Sple2n Within norn3l limits Atrophy mild moderate Fibrosis moderate Hematopoiesis, extramedullary, increased mild noderata marked Hemosiderosis minimal mild moderate 'lecrosis moderate 0 0 0 0 12) 32) 12 31 0 0 0 1 0 1 8) 7) 0 0 0 0 0 0 0 0 0 3 3 5 3 5 1 0 1 0 14) 34) 13 32 0 2 0 0 1 15) ( 32) 15 32 16) ( 34) 6 23 0 0 0 0 0 0 0 1 0 1 4 0 2 0 1 0 1 0 5 11 0 0 5 11 0 0 0 1 0 1 0 0 0 0 0 0 15) 33) 13) 14 30 12 0 0 1 0 0 0 0 0 0 3) 3) 6) 0 0 1 0 0 1 0 0 3 0 0 1 0 0 1 2 2 4 2 2 4 0 0 0 0 0 0 17) 31) 0) 17 31 0 0 0 0 0 0 0 0 0 0 (19) ( 31) ( 0) 19 31 0 (11))( 31) (15) 5 is 9 3 3 0 2 0 0 1 0 0 1 0 0 0 0 0 0 0 2 0 0 0 0 0 1 a 0 13 13 5 0 0 0 9 13 4 1 0 1 1: 0 0 0 0 0 1 0 0 1 0 0 33) 10) 32) 33 10 32 0 0 0 0 0 0 0 0 0 10) 1) 6) 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 9 1 4 9 1 4 0 0 0 0 0 0 1) 0) 0) 1 3 0 0 .v1 0 0 0 0 0 0 0 0) ( 0) ( 0) 0 0 35) (12) ( 33) 2@ 7 35 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 2 0 1 1 0 1 1 0 0 0 0 4 3 3 1 0 0 3 1 3 0 2 0 0 0 0 0 0 0 Titles: Group 1 CO!ITROL 0 ppm Group 2 FM-3924 100 ppm Group 3 FM-3924 30 p;xn Group 4 FM-3924 10 ppin Total Examined OOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 172 Microscopic Incidence Page: 24 Non-NeoplasticIncidencefor Males (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats Project ?lumber:0281CROO12 Species: Rat Table: 7 Tissue/ Diagnosis/ Modifier Stomach Within normal limits Edema moderate marked Gastritis,acute moderate I-lineralization mild f.'ecrosis n)od-.-trea Ulcer moderate iiiarked Tes,6is/Epididymis Within normal limits Leydig cell hyperplasia minin,il Mineralization mild Polyarteritis nini,-iial mild moderate marked Tubule atrophy, aspermatogenesis minimal mild moderate marked Vdscular mineralization minirial mild moderate Thyroid Within normal limits Cyst, colloid mild Foliicularhyperplasia,cystic mild moderate marked Group 1 Group 2 Group 3 Group -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 16) 33) 11 33 3 0 2 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 1-3-) 33) 13 25 0 0 0 0 0 1 0 1 1 5 0 0 1 1 0 1 0 3 3 4 0 0 1 1 I 1 1 2 0 0 0 0 0 0 0 0 12) 31) 11 25 0 1 0 1 0 1 0 0 0 1 0 0 19) 31) 15 31 2 0 2 0 0 0 D 0 0 0 0 0 0 0 2 0 2 0 0 0 0 0 0 0 19) 31) 13 23 1 0 1 0 0 1 0 1 0 2 0 0 0 1 0 0 0 1 3 3 1 0 0 1 0 2 2 0 3 3 2 1 1 2 0 0 13) 27) 12 22 1 1 0 0 0 2 0 1 Av 0 0 1 15) 35) 12 33 1 0 1 0 0 0 0 1 0 1 1 0 1 0 0 0 0 0 1 1 1 0 0 0 14) 35) 9 31 0 0 0 0 0 0 0 0 2 0 0 0 1 0 1 3 0 0 4 2 0 0 1 0 2 1 1 1 0 2 0 0 0 2 0 3 15) 33) 13 24 0 3 0 0 1 0 1 0 0 0 0 0 11) 37) 13 3 -.'@ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 1 0 12) 3^0) 10 24 0 0 06 0 3 0 0 0 4 0 1 0 2 0 1 1) 0 1 3 0 3 0 0 1 0 0 3 1 6 0 2 1 3 0 1 10) 36) Pi 29 0 3 0 3 0 1 0 0 0 0 0 1 Titles: Group I CO!ITROL 0 ppm Group 2 FM-3924 100 ppn Group 3 FM-3924 30 ppm Group 4 FM,3924 13 ppm Total Exa-nined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 17 3 Microscopic Incidence Page: 25 non-NeoplasticIncidencefor Males (continued) Riker Laboratories.Inc. 3t-i FM-3924: Two Year Oral Toxicity-OncogenicftyStudy in Rats Project tlunber:0281CROO12 Species: Rat Table: 7 Tissue/ Diag-iosis/ Modifier Thyroid (continued) Hyperplasia,C cell mild moderate Hyperplasia,follicularcell mild Ultinobranchfalcyst Trachea Within normal limits Cyst Tracheitis, acute mild Tracheitis,chronic mild moderate Urinary Bladder Wi*,hinnornal limits Calculus Cystitis,acute mild .noderatl, marked Cystitis,chronic mild Epithelialhyperplasia,papillary marked Epithelial hyperplasia, simple mild moderata marked Hemorrhage mild marked Ulcer Group 1 Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 0 1 0 1 0 0 0 0 0 0 1 1 15) 34) 15 34 0 0 0 0 a 0 0 0 0 0 0 0 13) 33) ill, 32 0 3 1 0 0 0 1 0 0 0 3 0 0 0 0 0 0 0 2 1 2 1 0 0 0 0 1 0 0 0 1 0 0 0 2 2 2 2 0 0 0 0 0 0 1 1 18) 29) IS 24 0 3 0 0 0 0 0 2 0 2 0 0 13) 30) 14 30 0 0 2 0 1 1 n 0 1 0 0 0 0 0 1 0 1 0 2 0 2 3 11 0 0 0 1 0 1 3 0 0 0 0 0 3 0 3 0 0 0 0 0 0 2 4 15) 35) 15 27 0 1 0 1 0 1 0 6 0 5 0 1 13) 34) 11 30 0 1 1 2 0 1 1 0 0 1 0 1 0 1 3 0 0 0 2 4 1 1 1 2 0 1. 0 0 0 0 0 0 3 1 3 2 0 1 0 1 1 0 1 0 1 1 11) 37) 11 @o 0 0 0 0 0 0 a 7 0 5 2 11) 38) 9 37 1 1) 0 a 0 0 0 0 3 0 0 0 0 0 1 0 10 0 1 1 0 0 0 0 0 0 0 .0 0 0 Au Titles: Group 1 CONTROL 0 pp.-.i Group 2 FM-3924 100 pprn Group 3 FM-3924 30 ppm Group 4 F14-3924 10 ppm Total Examined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 174 Microscopic Incidence Page: 26 Mon-Neoplastic Incidence for Females Riker Laboratories. Inc. 3M FM-3924: Two Year oral Toxicity-Oncogenicity Study in Rats Project Number: 0281CROO12 Species: Rat Table: Tissue/ Diagnosis/ Modifier Adrenal Within normal limits Cortical atrophy moderate m3rked Cortical degeneratioii mild moderate marked Cortical vacuolation minimal mild ioderate marked Hematopoiesis, extramedullary mi ni-.Ial mild moderate I-ledullarcyell hyperplasia @.iIi d Ilecrosis i,ioderate marked Ilodularhyperplasia, cortex r.iIid moderate Pigment, bro,.ii mild Sinusoidal ectasia, cortex minimal mild moderate marked Aorta Within nornal limits Mineralizatio,i mild Bone Arthritis, synovitis; joints moderate Group I Group 2 Group 3 Group 4 ----------- ----------- ----------- ------------ DOS SAC DOS SAC DOS SAC DOS SAC 25) 25) 2 0 0 0 0 0 0 0 2 5 1 0 1 3 0 2 3 2 0 0 2 1 1 1 0 0 4 0 0 0 3 0 1 0 I 2 1 2 3 0 1 0 2 0 0 C) 0 0 0 0 1) 0 3 0 19 23 0 1 8 4 5 8 5 9 21) 23) 17 23 2 0 2 0 3) 0) 0 0 0 0 15) 34) 4 6 1 1 1 1 0 0 0 0 0 0 0 0 0 5 6 0 0 4 5 1 0 0 1 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 1 0 1 0 3 0 0 1 1 a 26 1 1 2 12 4 4 1 9 14) 33) 14 33 0 0 0 0 0) 1) 0 1 0 1 26) 23) 2 2 1 0 0 0 1 0 3 6 1 3 2 3 0 0 5 2 1 0 2 1 2 1 0 2 0 .3 0 1 0 1 0 0 1 0 1 1 0 0 0 1 0 1 1 1 0 0 1 0 0 0 0 20 19 2 1 5 4 ?1 5 5 9 0) 3) 0 0 0 0 0 0 0) 0) 0 u 0 c 27) 22) 3 1 0 0 0 0 0 0 2 2 1 0 1 1 0 1 4 1 0 0 3 1 1 0 0 @i 1 0 1 0 0 0 r) 0 0 0 0 0 0 0 0 0 0 0 0 0 r, 0 0 0 c@ .9 .3 15 21, 1 0 5 6 7 6 3 9 0) 0) 0 0 0 3 0 0) 0) 0 0 1 6 Titles: Group 1 CONTROL 0 ppm Group 2 FM-3924 100 ppn Group 3 FM-3924 30 ppin Group 4 FM-39L'4 10 pp-n Total Exami-ied DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) Microscopic Incidence Page: 27 175 Non-Neoplastic Incidencefor Females (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0231CROO12 Species: Rat Table: 8 Tissue/ Diagnosis/ I-lodifier Bone Marrow Within normal limits Brain Within normal limits Clitoral Gland Cyst moderate Inflammation, chronic moderate Esophagus Within normal limits Eye Within normal limits Cataract Keratitis,acute marked Keratitis,chronic mild Panophthalmitis marked Phthsis bulbi noderate Retinal atrophy nild moderate m-3rked Heart Within norriallimits Endocarditis, chronic mild t.iyocardiaflibrosis mild moderate @iyocarditis,chronic nonsuppurative minimal mild moderate Pericarditis,chronic Kidney moderate Within normal limits Group 1 Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SA@6 ( 25)( 25) 23 25 (25)( 2S) 25 24 0) 0) 0 0 0 0 0 0 0 0 15) 21) 14 21 20) 23) 17 21 1 0 1 0 1 0 0 0 a 0 0 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 25) 25) l@f 14 0 3 0 0 0 2 0 2 0 0 :1 10 0 0 4 10 2 0 0 0 0 0 25) 25) 3 3 ( 16)( 34) 16 34 ( 16) ( 34) 16 34 ( 0) ( 0) 0 0 0 0 0 0 0 0 (13) ( 30) 13 30 (12) ( 34) 11 30 0 1 3 0 u 0 0 0 0 0 0 1 0 1 1 0 0 3 0 3 1 1 3 1 0 1 16) 3!) is 31 a 0 0 0 0 1 0 1 1 0 2 0 2 1 0 0 0 0 0 0 34) 4 4 ( 0) ( 0) 0 0 ( 3) ( 0) 3 0 ( 0) ( 0) 0 0 0 0 0 9 0 0 (25) t 20) 25 20 ( 2) ( 2) 2 1 3 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0. 0 0 1 u 3 0 0 0 1 27) 23) 22 17 0 1 0 1 2 3 2 3 0 0 2 5 1 1 1 4 0 0 1 0 1 0 27) 23) 5 3 ( 0) ( 0) 0 0 ( 1) ( 1) 1 1 ( 1) ( 1) 1 1 0 1 0 1 0 1 (24) ( 21) 24 21 ( 2) ( 2) 1 2 0 0 0 0 1 0 1 1 0 0 0 0 11) 1 0 0 0 3 @l 0 0 3 0 2'-") 22) 29q is 3 0 0 0 1 2 1 1 0 1 5 i 2 3 1) 3 r) 3 0 0 28) 22) 6 5 Titles: Group 1 CONTROL 0 ppin Group 2 FM-3924 100 ppm Group 3 F[4-392430 ppm Group 4 FM-3924 10 ppm Total Exanined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s)* 17 6 Microscopic Incidence Page: ?3 won-Meoplastic Incidence for Females (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 3231CROO12 Species: Rat Table: Tissue/ Diagnosis/ Modifier Kidney (continued) .Calculus moderate Chronic progressive nephrop3thy minimal mild moderate marked Cyst moderate He-,iatopoiesise,xtramedullary mild moderate Hydronephrosis moderate Hyperpl-asia,pelvic epithelium mild moderate Mineralization mild Nephritis,acute ..iIid Nephrosis mild moderate mar?.ed Pelvic mineralization minimal mild moderate ..tarked Pigment, co-iv.tub. epithelium minimal mild Polyarteritis moderate Protein resorption droplets mild moderate marked Pyelitis, acute mi ninal Group 1 Group 2 Group 3 Group I -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 0 0 0 0 12 13 3 4 5 10 2 3 2 1 2 1 2 0 0 0 0 0 0 0 1 0 1 0 4 1 4 1 0 0 .2 @2 0 0 0 0 0 7 0 1 0 3 0 2 14 16 4 6 8 8 1 2 1 0 0 0 0 0 0 0 0 0 c a 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 17 4 0 0 1 1 0 0 0 0 0 0 D 0 0 0 0 0 0 0 3 0 1 0 1 0 0 3 '0 0 0 r) 0 0 0 0 0 0 D 0 0 0 0 10 23 3 10 1 9 1 2 0 2 0 5 0 1 0 4 3 1 1 1 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 14 12 7 5 5 5 2 1 0 1 0 0 0 0 2 0 1 0 1 0 0 5 0 0 2 1 1 1 1 0 1) 0 a 0 0 0 3 0 2 1 1 0 1 0 0 1 12 12 5 If. 6 6 1 2 0 0 0 0 0 0 0 0 0 D 0 v 0 0 0 0 0 0 0 0 1 1 1 0 0 1 0 1 13 1-; 14 1 6 1) 1 3 1 0 0 0 1 0 1 0 0 0 0 1 0 0 3 0 3 0 0 0 0 o; 0 0 1 11 1 0 1 1 0 0 1 0 0 1 13 10 5 2 6 7 1 1 1 0 1 0 0 3 1 0 0 0 0 1 4 0 1 I'll 11) 3 3 1) 1 1 11 0 Titles: Group 1 CONTROL 0 ppm Group 2 FM-3924 130 ppm Group 3 Ft4-392430 ppm Group 4 FM-3924 10 ppm Total Examin,,-d DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sa.-rifice(s) 77 Microscopic Incidence P3ge: 119 Non-Neoplasti,I-ncidencefor Females (continued) Riker Laboratories, Inc. 3M FM-3924: Two Year Oral -.oxicity-OncogenicityStudy in Rats Pro,jectNumber: 0281CROOIZ Species: Rat Table: 8 Tissue/ Diagnosis/ .4odifier Kidney (continu,,d) Pyelitis.acute mild Pyelonephritis,acute moderate marked Vacuolation,conv. tub. apitileium minimal mild moderate Large Intestine Within nom,al li*,nits fleiiatodiasis Liver Within normal limits Cysr.oiddegeneration nild Hen.atopoiesis,extramedullary minimal mild moderate Hepatocyte alteration,basopliilic mi,,ii,mal nild moderate Hepatocytealteration, eosinophilic mild moderate Nepat3cyte alteration, vacuolated mild Hepatocyte vacuolatior. mi ni-nal mild moderate mar@-,2d Hyperplastic nodule Megal ocytosi s minimal mild moderate marked Group I Group 2 Group 3 Group I -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 0 1 0 1 0 0 0 1 0 0 0 0 0 1 0 24)( 23) 22 22 1 1 25)( 25) 1 0 0 0 0 0 3 0 0 0 3 0 0 0 1 7 0 0 1 5 0 2 1 2 0 2 1 0 2 11 2 11 is is I I 9 13 3 1 2 3 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 3 0 0 0 0 5 0 2 0 2 0 1 0 (14) ( 3-1) 13 31 0 3 (16)( 34) 0 0 0 4 0 4 1 2 .0 .0 1 2 0 0 3 2 0 0 0 2 0 0 0 0 0 0 0 0 0 6 0 ;ro 12 29 1 0 4 18 6 10 1 1 2 7 11 33 3 1 8 17 3 13 0 2 0 1 1 0 0 0 1 0 0 0 0 0 0 0 0 0 ( 1) t 0) 1 0 0 0 (27)( 23) 4 2 0 0 0 0 8 2 4 2 3 0 1 0 0 1 0 1 0 3 0 0 0 0 0 0 0 3 0 6 0 6 11 lo@ 2 5 7 3 1 1 1 0 0 0 0 1 0 0 0 1 0 0 0 0 1 1 0 3 0 0 0 a 1 0 0 3 1 0 0 0 ( 3) ( 0) 2 0 0 0 (28) ( 22) 4 1 0 3 0 0 1 3 0 3 0 0 0 0 3 5 0 2 2 1 1 0 0 3 0 0 0 5 0 6 15 12 1 1 10 5 1 2 0 0 0 0 0 0 0 0 0 3 0 0 Titles: Group I CONTROL 0 ppm Group 2 FM-3924 100 ppm Group 3 FM-3924 30 ppm Group 4 FM-11924 10 ppm, Total Exa-nined BOSs Unscheduled Death(s) SACs Protocol Scheduled Sacrifice(s) 17 8 Microscopic Incidence Page: 30 tooi-f.2oplaslliicidcnce for Faral@s (coiiti.-iuad) Ri!.crLaboratorios,Inc. .3a'-i Fi-i-3)@:T:wo Y2ar Oral T3xicity-Onc3genicityStudy in Rats Sp2@-ic.,:Pat Tabl3: Tis:;u:/ Di a Ii.:)difier Liv@!r kco:-.tinu:!dj a:tivi,y, incre.-.sed r7,od-irite r s i3 ,iiId r,.c d Pic,::-.:!anrto,;.:i 77! -1 i 1 P:)rt--l bil.: @,.ict prz)lif.:!ra-ci:?,i 7,i;ii;131 Group 1 Group 2 %3roup 3 -------------------------------------------- DOS SAC "UOS caAC DOS SAC DOS SAC 1 I G 3 0 2 0 1 2 1 i 0 3 u 0 z 7 7 P@or -il C:-,)C'@",I inl'iItr L--- 0 0 3 T,@I a:-,i n Alv,!olar iii1id .quder@'.e Cyst Ed -'S 2 3 L 1 3 2 11 17 7 l@ 17) .'3) 2 2 u 5 1' Gran-,!l-7.ia ,,iid Titles: GrL@ip I '@'0!.T@OL pp-.i Gra@;p 2 F;.',-3@'@4 P;)Il Group 2 F14-39':! 3@j pp,-.1 G)-@,u? 4 in pp,@i Total Ex3riin2d DOS- Unsch,,duled D-2ath(s) SP.C- Protocol Sch3duled Sacrit'i-e(s) 179 '4icroscopic Iicidc-!,:!P230: '@l Non-NeoplasticIncidencefor Females(continued) Riker Laboratories,Inc. 3M FM-3 924: Two Year Oral Toxicity-OncogenicityStudy in Rats . Project Number: 0281CROO12 Species: Rat Table: 3 Tissue/ Diagnosis/ Modifier Lung (continued) Hemorrhage mild moderate marked Hyperplasia, septal cell mild f4ineralization mild Pelvic mineralization mild Parivascularnononuclear infiltrate minimal mild moderate Pigment moderate Pleuritis,chronic moderate Pneumonia, acute exudative mild modera*6e Pneumonia, bronchopneumonia moderate Pneumonia, interstitial,chronic minimal mild moderate Thrombus moderate Vascular minerdlization mini,.qal mild Lymph Node (mesenteric) Within normal limits Hemorrhage mild noderate Polyarteritis mild moderate Group I Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 9 5 a 3 1 1 0 1 0 0 0 0 0 0 0 0 0 0 0 3 4 9 0 1 4 7 0 1 0 1 0 1 0 0 0 0 1 0 0 0 1 0 0 0 0 0 4 3 u 1 4 3 0 0 0 0 0 0 12 10 0 0 12 10 19) 23) 14 22 2 1 1 1 1 0 0 0 0 1) 0 0 5 9 a 7 0 2 1 0 0 0 0 0 3 0 0 0 1 0 1 0 4 15 1 1 3 13 0 1 0 0 0 0 0 0 0 0 2 0 2 0 0 0 0 0 0 0 2 7 0 1 2 6 0 0 0 0 0 0 13 25 u 13 25 9) 29) 24 1 3 1 1 0 2 0 2 0 1 0 1 9 5 6 4 2 f) 1 1 1 0 1 0 0 1 0 1 0 0 0 0 5 5 0 1 5 4 0 0 0 0 0 0 1 0 1 0 1 0 1 0 0 0 0 0 0 0 2 4 0 0 2 4 0 0 0 0 3 0 23 19 2 2 21 17 3) 3) 7 2 0 3 0 0 0 0 0 0 0 0 0 0 8 3 5 0 2 3 1 0 0 1 0 1 0 0 r) 0 0 0 0 0 6 3 0 1 5 2 1 0 0 0 0 0 0 0 0 0 0 0 3 3 ii 0 1 0 1 0 3 7 0 0 2 7 1 0 1 0 1 0 23 17 2 1 21 16 1) 0) 0 u 1 0 0 0 0 0 0 0 0 1) 0 0 Titles: Group 1 CONTROL 0 ppm Group 2 FM-3924 100 ppm Group 3 FM-3924 33 ppm Group 4 F14-392410 ppm Total Examined DOS- Unscheduled Death(s) SACM Protocol Scheduled Sacrifice(s) 18 0 Microscopic Incidence Page: 32 Mon-Neoplastic Incidence for Females (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Nunber: 0281CROOI@9 Species: Rat Table: 1 Tissue/ Diagiosis/ Modifier Lymph Node (mesenteri@-)(continued) Sinusoidal ectasi3 Moderate Mamary Gland Within normal limits Galactoccle Labular hyperplasia moderate Ovary Within normal limits Cyst Tubular hyplrplasia mild moderate marked Paicreas Within normal liriits Acinar atr-)phy mini,n3l ,.iIid moderate .,irak ed Cyst Hyperplasia, isletcall mild Polyarteritis marked Parathyroid 1.4ithiiniornal limits Hyperplasia .nild Sinusoidal ectasia moderate P-ituitary Within normal li,-iits Hemorrhago marked Necrosis moderatc Pigment, brown moderate Group I Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 1 0 1 0 23)( 23) 4 9 5 4 4 3 1 0 25) 23) 19 17 3 3 0 0 0 a 0 a 0 0 24) 25) 22 15 0 6 0 1 0 0 3 0 0 0 1 0 0 0 0 0 0 0 u 5) 0) 5 0 0 0 0 0 0 0 a 0 22) 24) 5 7 1 0 1 3 1 0 1 0 0 0 0 0 0 0 0 @o ( 14)( 33) 10 19 0 3 0 1 0 0 14) 34) 12 14 0 5 2 13 2 6 0 7 0 0 14) 34) 12 33 1 3 3 0 0 3 1 0 0 0 0 0 1 0 1 0 0 0 0 0 3) 23) G 211) 0 1 0 1 0 1 0 1 IS) 34) 3 10 0 3 0 0 0 0 0 0 1 0 1 0 1 0 1 ( 23)( 23) 10 10 2 3 2 1 0 0 2S) 23) 19 12 2 3 4 7 4 3 0 2 0 2 17) 17) 15 13 1 3 0 0 1 2 0 0 3 1 3 0 0 0 0 0 I, 3 0 0 16) 15) 16 15 0 0 0 0 0 3 0 0 '.11(1)21) 3 4 1 0 0 0 0 0 0 0 0 0 0 0 13 0 0 ( 25)( 21) 14 9 3 3 2 2 0 0 25) 21) 23 13 1 5 1 5 0 3 1 2 3 0 21) 20) 19 is 0 2 0 0 0 0 0 2 D 0 1 0 1 0 1 1 1 19) IP,) 19 0 0 3 0 0 u 0 0 ?5) 21) 5 6 0 0 0 0 3 0 3 0 0 0 0 Titles: Group 1 CONTROL ppm Group 2 FM-392't100 ppm Group 3 FM-3924 3D ppm Group 4 FM-3924 10 ppm Total Examined DOS* Unscheduled Death(s) SAC* Protocol Scheduled Sacrifice(s) 18 1 flicroscopicIncidence Page: 33 Von-MeoplasticIncidencefor Fmales (continued) Riker Laborstori*s,Inc. 3H FM-3924:Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0281CROO12 Species: Rat Table: 8 Tissue/ Diagnosis/ Modifier Group I Group 2 Group 3 ---------------------------- DOS SAC DOS SAC SAC Group 4 ----------- DOS SAC Salivary Gland Within normal limits Hemorrhage Sialadenitis,chronic mild moderate Skin Within normal limits Acanthosis mild Pododematitis,ulcerative marked Ulcer moderate marked Small Intestine Within normal limits Ulcer Spinal Cord Within normal limits 14alacia moderate Spleen Within normal limits Hematopoiesis.extramedullary,increased minimal mild moderate marked Hemosiderosis mild moderate marked Stomach Within normal limits Edema moderate Gastritis,acute moderate Granulon,a minimal 19) 24) 18 24 00 10 00 10 3) 3) 00 01 01 00 00 20 10 10 ( 24)( 25) 24 25 00 (25)( 23) 23 23 10 10 25) 25) 4 11 72 00 1 1 41 20 12 13 8 13 40 00 25) 25) 20 25 00 00 0 00 00 13) 33) 13 32 00 01 00 01 0) 2) 01 00 00 01 01 00 00 00 (14)( 34) 14 33 01 (15)( 34) 15 34 0D 00 16) 34) 8 20 20 00 00 20 0 0 6 14 2 11 3 3 10 16) 34) 13 34 00 0a 20 2 1) 0 00 19) 20) is 19 10 01 01 00 5) 4) 02 00 00 11 11 00 00 00 1) 0) 10 00 0) 0) 00 00 00 27) 23) 9 20 10 1 00 1 1 30 60 82 32 50 00 26) 23) 21 23 20 20 10 1 ,.I 10 10 20) 20) 20 20 00 00 00 00 5) 1) 31 00 00 0D 00 00 00 00 1) 0) 00 00 0) 0) 00 00 00 28) 22) 7 17 44 01 12 ":. 1 10 is 1 81 60 10 28) 22) 26 21 00 00 10 0 0 Titles: Group 1 CONTROL ^vppm Group 2 FM-3924 100 ppm Group 3 FM-3924 30 ppe Group 4 FM-3924 10 ppo Total Examined DOS- Unscheduled Death(s) SAC* ProtocolScheduledSacrifice(s) 182 Microscopic IncidencePage: 34 Mon-Meoplastic Incidence for Females (continued) Riker Laboratories,Inc. 3H FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0281CROO12 Species: Rat Table: 8 Tissue/ Diagnosis/ Modifier Stomach (continued) Hemorrhage moderate Mineralization mild Necrosis mild moderate Ulcer marked Thyroid Within normal limits Follicularhyperplasia,cystic mild marked Hyperplasia. C cell minimal mild moderate Ultimobranchialcyst Trachea Within normal limits Urinary Bladder Within normal limits Calculus Cystitis.chronic marked Epithelialhyperplasia,papillary marked Epithelia] hyperplasia, simple mild moderate Uterus Within normal limits Cystic glands minimal mild moderate marked Exudate, lumenal moderate Group 1 Group 2 Group '3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 2 0 1 0 1 0 0 0 1 0 1 0 1 0 0 0 0 0 0 0 25) 25) t 13) 33) 20 23 12 27 1 0 0 1 1 D 0 0 0 0 0 1 0 0 1 3 0 0 0 0 0 0 0 2 0 0 1 1 2 1 0 0 25) 25) (14) 34) 25 25 14 34 25) 25) (13) f 34) 17 25 12 33 1 0 0 0 0 0 0 0 0 0 0 0 1 D 0 0 1 0 0 0 7 0 1 1 6 0 1 1 1 0 0 0 25) 25) 14) 34) 21 17 11 20 2 5 2 12 0 0 0 1 0 1 1 5 2 1 1 4 0 3 0 1 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 2 0 0 0 20) 18) 18 12 0 0 0 0 0 0 1 3 0 1 1 2 0 0 1 1 25)( 21) 25 21 23) ( 21) 20 21 0 0 0 0 0 0 0 0 0 0 2 0 2 0 0 0 24) 23) 17 is 3 3 0 0 1 0 2 2 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 23) 22) 19 17 0 0 0 0 D 0 0 0 0 0 0 0 0 0 3 4 (24) 22) 24 22 (25) f 22) 21 22 0 0 1 0 1 0 1 0 1 0 D 0 0 0 0 0 26) 22) 22 11 3 5 0 0 0 2 0 2 3 1 0 0 0 0 Titles: Group 1 CONTROL 0 ppm Group Group Group 2 FM-3924 100 ppm 3 FM-3924 30 ppm 4 FM-3924 10 ppm Total Examined DOS- Unscheduled Death(s) - SAC- Protocol Scheduled Sacrifice(s) 18 3 Microscopic Incidence Page: 35 Mon-Meoplastic Incidence for Females (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats Project Number: 0281CROO12 Species: Rat Table: 8 Tissue/ Diagnosis/ Modifier Uterus (continued) Hydrometra moderate marked Hyperplasia, endometrial moderate Inflawation, acute marked Metritis,acute mild Polyarteritis moderate Group 1 Group 2 Group 3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 1 1 0 0 1 1 0 1 0 1 0 0 0 0 0 1 0 1 0 1 0 1 Title!: Group 1 CDNTROL 0 ppm Group 2 FM-3924 100 ppm Group 3 FM-3924 30 ppm Group 4 FN-3924 10 ppm Total Examined DOSs Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 18 4 Microscopic Incidence Page: 36 NeoplasticIncidencefor Males Riker Laboratories.Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats - One Year Interim Table: 9 Project Number: 0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Ma@ry Gland Adenocarcinoma Pituitary Adenoma Group 1 Group 2 ---------------------- 3) 1) 0 1 24) 13) 0 1 Titlesi Group 1 CONTROL 0 ppo Group 2 FN-3924 100 ppm Total Exmined 18 5 Microscopic Incidence Page: 37 Neoplasti-CIncidence for Females Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStuOy in Rats - One Year Interim Table: 1D Project Number: 0281CROO12 Species: Rat Tissue/ Diagnosis/ Modifier Mammary Gland Adenocarcinoma Pituitary Adenoma Group I Group 2 ---------------------- 15) 15) 0 1 15) 15) 1 2 Titles: Group I COMOL 0 ppm Group 2 FM-3924 100 ppo Total Examined 18 6 Microscopic Incidence Page: 3a NeoplastiIcncidenceforMales Riker Laboratories,Inc. 3M FM-3924:Two Year Oral Toxicity-OncogenicitSytudy in Rats Project Number: 0281CROO12 Species: Rat Table: 11 Tissue/ Diagnosis/ Modifier Adrenal Carcinoma. cortical Pheochronocytoma. benign Pheochromocytoma, malignant Hemolymphoreticular neoplasm present Bone Osteosarcoma Brain Astrocytoma. benign Oligodandrogliona, benign Hemolymphoreticular neoplasm present Eye Henolymphoreticular neoplasm present Heart Hemolynphoreticular neoplasm present Kidney Adenoma Hemolymphoreticular neoplasm present Liver Hepatocellular carcinoma Hemolymphoreticular neoplasm present Lung Adeno,ia Hen.olynphoreticularneoplasm present Lymph Node (abdominal) Hemolymphoreticular neoplasm present Lymph flode(nesenteric) Hemangiosarcoma Hemolymphoreticular neoplasm present Pancreas Adenoma Islet cell adenona Islet cell carcinoma Hemolymphoreticular neoplasm present Parathyroid Adenoma Pituitary Adeno= Salivary Gland Hemolymphoreticular neoplasm present Group I Group 2 Group -3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC ODS SAC 15)( 34) 0 1 I 1 0 0 0 0 0) 2) 0 0 16) 34) 0 1 1 0 0 0 12) 33) 0 0 (16) 34) 1 0 (16)( 34) 0 0 1 0 (16)( 34) 2 1 2 1 (16) ( 34) 0 0 3 1 0) 0) 0 0 12) 33) 0 0 1 0 13) 33) 0 0 0 1 0 0 1 0 6) 16) 0 0 15) ( 33) 6 11 12) ( 32) 0 0 ( 19)( 31) 14) 35) 0 1 0 0 0 0 1 3 0 0 D 0 1 0 0 0 1) 1) 0) 0) 1 0 18) 31) 0 0 0) 0) 0 1 0 0 0 0 0 0 1 0 0 0 17) 31) ( 1) 1) 1 0 0 0 (19)( 31) (15) 35) 2 0 1 0 (19)( 31) (15)( 35) 0 0 0 0 1 0 1 0 f 19)( 31) ( IS)( 35) 1 1 0 1 2 0 1 1 (19) ( 31) ( 15) 35) 0 1 0 0 2 3 1 1 0) 0) 0) 1) 0 0 0 1 13) 29) 1)'(1) 0 0 0 0 1 0 1 0 15) 29) 14)( 35) 1 0 3 0 1 1 1 2 0 1 0 0 1 0 1 0 (13) 16) ( 9) ( l@L@,) 0 1 0 1 (17) ( 30) (15) ( 33) 4 16 11 18 (15) ( 30) (13)( 33) 1 0 0 0 12) ( 33) 0 0 1 3 0 1 0 0 1) 0) 0 0 0) 0) 0 0 0 0 0 0 1) 4) 0 0 (12)( 38) 0 0 (12)( 38) 0 1 1 0 (12)( 38) 1 0 1 0 (12) ( 38) 0 0 1 3 0) 0) 0 0 0) 1) 0 1 0 0 11) 37) 0 0 0 1 0 0 0 0 9) 26) 0 0 (11) ( 36) 6 16 (10) ( 32) 0 0 Titles: Group I Group 2 Group 3 Group 4 CONTROL FM-3924 FM-3924 FM-3924 0 ppm 100 ppm 30 ppm 10 ppm Total Examined DOS= Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(sY 18 7 Microscopic Incidence Page: 39 Neoplastic Incidence for Males (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0231CROO12 Species: Rat Table: 11 Tissue/ Diagnosis/ Modifier Skin Basal cell tumor, benign Fibroma Fibrosarcoma Keratoacanthon-a Liposarcoma Papilloma Squamous cell carcin=a Hemolymphoreticular neoplasm present Small Intestine Hemolymphoreticular neoplasm present Soft Tissues (head) Hemangiosarcoma Zymbal gland carcinoma Soft Tissues (neck) Fibroma Fibrosarcoma Soft Tissues (thorax) Liposarcoma Spleen Hemangiosarcona Hemolynphoreticular neoplasm present Stonach Hemolymphoreti,@ular neoplasm present Testis/Epididymis Mesothelio= , benign Thymus Hemolymph3reticular neoplasm present Thyroid C cell adenona C cell carcinoma Follicular adenoma Urinary Bladder Papilloma Hemolymphoreticular neoplasm present Hemolymphoreticular System [f affected] Malignant lymphoma. lymphocytic Malignant lymphoma, histiocytic Malignant lymphoma, mixed Group 1 Group 2 Group *3 Group 4 -------------------------------------------- DOS SAC OOS SAC DOS SAC DOS SAC 8) 7) 3) 3) 6) 10) 0 0 0 0 0 1 1 0 1 0 0 1 1 0 0 1 0 0 1 2 1 0 0 1 0 0 1 0 (14) 34) 0 0 0 0 0 0 0 0 0 0 17) 31) 0 0 0 0 0 0 1 0 0 0 0) 1) 1 0 0 0 0 0 ( 0) 0) 0 0 2) 0) 1 0 0) 0) 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) 0) 0) 0) 0) 0) 6- o 0 0 0 0 16) 34) 19) 31) 15)( 35) 0 1 0 0 0 0 1 1 1 0 1 1 16) (33) ( 19) ( 31) ( 15) ( 35) 1 0 0 0 0 0 16) (33) ( 19) ( 31) ( 14) ( 35) 0 0 0 0 0 0 1) 0) 1 0 12) 31) 0 0 1) 0) 1 0 18) 27) 1 0 0) 0) 0 0 15) 33) 0 2 0 2 0 0 13) 33) 1 0 0 0 18) 30) 0 1 0 1 13) 34) D 0 0 0 0 0 1 0 C 31 C 1] 0 0 31 01 0 0 11 t 12 0 0 2 0 0 0 3 1 1 0 0 1 0 0 0 0 1 0 1) 6) 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0) 0) 0 0 0) 0) 0 0 0 0 1) 1) .0 1 1 0 1) 0) 1 0 12) 33) 0 0 0 0 11) ( 37) D 0 12) ( 38) 0 1 0) 0) 0 0 10) 36) 0 3 0 0 0 0 11) 33) 0 1 0 0 C 11 1 01 0 0 1 0 0 0 Titles: Group I CONTROL 0 ppm Group 2 FN-3924 100 ppm Group 3 FK-3924 30 ppm Group 4 FN-3924 10 ppm Total Examined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 18 8 Microscopic Incidence Paga: 40 Neoplastic incidence for Females Riker Laboratories.Inc. 3M FM-3924: Two Year Oral Toxicity-OneogenicitY Study in Rats Project Number: 0281CROO12 Species: Rat Table: 12 Tissue/ Diagnosis/ 14odifier Adrenal Adenoma Adenoma, cortical Carcinoma, cortical Pheochromocytoma, benign Pheochromocytoma, malignant Hemolymphoreticular neoplasm present Aorta Hemolymphoreticular neoplasm present Bone i4arrow Hemolymphoreticular neoplasm present Brain Oligodendroglioma, benign Esophagus Hemolymphoreticular neoplasm present Eye Hemolymphoreticular neoplasm present Heart Hem.olymphoreticularneoplasm present Kidney Hemolymphoreticular neoplasm present Large Intestine Leiomyosarcoma Hemolymphoreticular neoplasm present Liver Hepatocellular adenoma Hepatocellular carcinoma Hemolymphoreticular neoplasm present Lung Hemolymphoreticular neoplasm present Lymph Node (mesenteric) Hemolymphoreticular neoplasm present Lymph Node (thoracic) Hemolymphoreticular neoplasm present Mammary Gland Adenocarcinoma Adenoma Carcinoma Fibroadenoma Hemolyr*horeticular neoplasm present Group 1 Group 2 Group -3 Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 25) 25) 0 0 0 0 0 0 0 2 0 0 2 0 21) 23) 2 0 25) 25) 2 0 25) 25) 0 1 15) 21) 1 0 20) 23) 1 0 25) ( 25) 1 0 (25) ( 2S) 3 0 (24) ( 23) 0 0 1 0 (2S) ( 25) 0 0 0 0 s 0 (25)( 25) 5 0 (19) ( 23) 3 0 ( 0)( 0) 0 0 ( 23)( 23) 4 3 2 1 0 1 6 4 2 0 15) 34) 26) 23) 27) 22) 0 0 0 0 0 0 0 0 1 0 1 0 0 1 0 0 0 0 0 1 0 0 1 0 0 0 1 0 14) 33) 0 1 1 0 0) 0) 0 0 2 0 0) 0) 0 0 16) 34) 0 0 0) 0) 0 0 0) 0) 0 0 16) 34) 0 0 0 0 3) 0) 0 0 0 0 1) 1) 0 0 13) 30) 25) ( 20) 24) ( 21) 0 0 0 0 0 0 12) 34) 2) ( 2) 2) ( 2) 0 0 0 0 0 0 16) 34) (27) ( 23) (28) ( 22) .1 0 0 0 1 0 16) 34) (27)( 23) (28) ( 22) 1 0 0 0 2 0 14) 34) ( 1) ( 0) ( 3) 0) 1 0 0 0 0 0 0 0 0 0 1 0 16) 34) (27) ( 23) (23) 22) 0 4 0 0 0 a 1 2 0 D 0 0 1 0 0 0 4 0 16) 34) (27) ( 23) (28) ( 22) 1 0 0 0 3 0 9) 29) ( 0) ( 3) ( 1) ( 0) 0 0 1 0 1 0 0) 0) ( 1)( 0) ( 0) ( 0) 0 0 1 0 0 0 14) 33) ( 23)( 23) (25) 22) 4 6 0 0 s 6 0 0 3 3 0 0 0 0 0 0 0 0 1 5 0 0 7 8 0 0 6 11 1 0 Titles: Group 1 CONTROL 0 ppm Group Group Group 2 F14-3924100 ppm 3 FM-3924 30 ppm 4 FM-3924 10 ppm Total Examined DOS* Unscheduled Death(s) SAC= Protocol Scheduled Sacrifice(s) 18 9 Microscopic Incidence Page: 41 Neoplastic Incidencefor Females (continued) Riker Laboratories,Inc. 3M FM-3924: Two Year Oral Toxicity-OncogenicityStudy in Rats Project Number: 0281CROO12 Species: Rat Table: 12 Tissue/ Diagnosis/ Modifier Mesentary Leiomyosarcoma Ovary Leiomy(xna Tubular adenoma Hemolymphoreticular neoplasm present Pancreas Acinar adenoma Islet cell adeno-na Islet cell carcinoma Hemolymphoreticular neoplasm present Parathyroid Adenoma Pituitary Adenocarcinoma Adeno,,ia Skin Fibroma Fibrosarcoma Lipoma Hemolymphoreticular neoplasm present Small Intestine Hemolymphoreticular neoplasm present Soft Tissues (leg) Hemolymphoreticular neoplasm present Spinal Cord Hemolymphoreticular neoplasm present Spleen Hemolymphoreticular neoplasm present Stomach Hemolymphoreticular neoplasm present Thynus Hemolymphoreticular neoplasm present Thyroid Adenocarcinoma C cell adenoma C cell carcinoma Hemolymphoreticular neoplasm present Urinary Bladder Transitionalcell carcinoma Hemolymphoreticular neoplasm present Group I Group 2 Group Group 4 -------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 0) 0) 0 0 25) 23) 1 0 0 4 2 0 24) 25) 0 0 0 1 0 1 2 0 5) 0) 0 0 22) 24) 0 0 16 17 3) 3) 1 2 0 0 0 0 0 0 24) 25) 0 0 0) 0) 0 0 25) 23) 1 0 (2S) 26) 3 0 (25) 25) 1 0 0) 0) 0 0 25) 25) 0 0 0 1 0 0 2 0 25)( 25) 0 0 1 0 0) 0) 0 0 14) 34) 0 0 0 3 0 D 14) 34) 0 1 0 0 0 0 0 0 6) 23) 0 1 15) 34) 0 0 12 23 0) 2) 0 0 0 0 0 0 0 0. 14) ( 34) 0 0 1) ( 0) 1 0 15) ( 34) 0 0 16) ( 34) 0 0 16) ( 34) 0 0 0) 0) 0 0 13) 33) 0 0 0 1 1 1 0 0 13)( 34) 0 0 0 0 0) 1) 0 1 2S) 23) 0 0 0 2 0 0 17) 17) 0 0 0 2 0 0 1 0 16) 15) 0 0 23) 21) 0 1 20 16 5) 4) 3 0 1 0 1 1 0 0 1) 0) 0 0 0) 0) 0 0 0) 0) 0 0 27)( 23) 0 0 26)( 23) 1 0 1) 0) 1 0 20) 18) 0 1 0 1 0 1 0 0 23) 21) 0 0 1 0 0) 0) 0 0 26) 21) 0 0 0 0 1 0 21) 20) 0 0 0 0 0 0 2 0 19) 18) 0 0 25) 21) 0 0 20 15 5) 1) 0 0 0 0 0 0 2 0 1) 0) 1 0 0) 0) 0 0 0) 0) 0 0 23) @12) 2 0 28) 22) 1 0 0) 0) 0 0 23) 22) 0 0 1 0 0 1 0 0 25) 22) 1 0 2 0 Titles: Group I Group 2 Group 3 Group 4 CONTROL FM-3924 FM-3924 FM-3924 0 ppin 100 ppm 30 ppm 10 ppm Total Examined DOS- Unscheduled Death(s) SAC- Protocol Scheduled Sacrifice(s) 19 0 Microscopic Incidence Page: 42 Meoplastic Incidence for Females (continued) Riker Laboratories,Inc. 3H FM-3924: Two Year Oral,Toxicity-oncogenicityStuOy in Rats Project Number: 0281CROO12 Species: Rat Table: 12 Tissue/ Diagnosis/ Modifier Uterus Adenoma Hemangioma Leiomyome Polyp Hemolymphoreticular neoplasm present Hemolymphoreticular System [# affected3 Malignant lymphoma. histiocytic Malignant lymphoma, lymphocytic Lymphosarcoma Group I Group 2 Group *3 Group 4-------------------------------------------- DOS SAC DOS SAC DOS SAC DOS SAC 25)( 25) ( 14)( 34) ( 24)( 23) ( 26)( 22) 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 a 0 0 0 0 0 1 01 2 0 C 51 C 0] 01 2 2 0 0 1 0 11 C 01 C 31 01 1 3 0 0 41 C 03 2 0 3 0 0 0 1 0 0 0 0 0 1 0 0 0 2 0 4 0 0 0 0 0 Titles: Group 1 CONTROL 0 ppm Group 2 FN-3924 100 ppo Group 3 F14-392430 ppm Group 4 FM-3924 10 ppm Total Examined DOSs Unscheduled Death(s) SAC= Protocol Scheduled Sacrifice(s) 19 1 Microscopic Incidence Page: 43 SummarizedSingleTabulatedAnimal Report IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FO-3924:Two Year OralToxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I --------------------------------------------------------------------- -- Animal Number: IR-3516 Sex: Male Group: Fate: (Veekz 53) 1 Year InterimSacrifice 1) CONTROL 0 ppe MacroscopicObservations: Microscopic Observations: Kidney Lung Lymph Node (sesenteric) Pancreas Parathyroid Small Intestine Thyroid -No visiblelesions. -Chronicprogressivenephropathy,mild -Vascularmineralization,minimal -Not examined,missing -Acinaratrophy,sild -Not examined,missing -Withinnormallimits Fewer than protocol number -Not examined, missing The followingtissuesmere found to be withinnormallimits: Brain, Spinal Cord, Bone Narrow,Spleen,Liver,Heart, Stomach,Large Intestine, UrinaryBladder,Aorta, Testis/EpididysisP,rostate,MammarySland, Pituitary,Adrenal,Trachea, Esophagus,SalivaryBland, Eye. ------------------------------------------------------------------------------------- -- Animal Number: IR-3517 Sex: Male Group: Fate: (Veekz 53) 1 Year InterimSacrifice 1) CONTROL 0 pps MacroscopicObservations: MicroscopicObservations: Kidney Lung Parathyraid Thyroid -No visiblelesions. -Chronic progressivenephropathy,minimal -Vascularmineralization,mild -Not examined,missing -Not examined,missing The followingtissues*ere found to be withinnormallimits: Brain, Spinal Card,Bone Marro*,Spleen,Liver, Heart, Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,TestislEpididysisP,rostate,MammaryBland,Pituitary, Adrenal,Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryBlind, Eye. ------------------------------------------------------------------------------------------- Animal Number: IR-3520 Sex: Mile Group: ( 1) CONTROL 0 ppe Fate: (Weekz 53) 1 Year InterimSacrifice Macroscopic Observations: -No visiblelesions. Microscopic Observations: Adrenal -Sinusoidalectasia,cortex,bilateral, moderate Kidney -Chronicprogressivenephropithy,sinisal --------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 1 19 2 SummarizedSingle tabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M Ffl-3924T:wo YearOral Toxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I ------------------------- ---------------- --- ---------- -------------------------- Animal Number: IR-3520 Sex: Hall Group: ( 1) CONTROL 0 ppe Fate:(Weekr 53) 1 YearInterimSacrifice MicroscopicObservations(continued): Liver Lung Lymph Node (sesenteric) Pirithyroid Pituitary -Hopitocytaelterationv,icuclatedf,ocil, minimal -Vascularmineralizationm,inimal -Not examined,missing -Not examined,not in planeof section -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Thyroid,Trachea,Esophagus,Pancreas, SalivaryGland,Eye. --------------------------------------------------------------------------------------- Animal Number: IR-3522 Sex: Halt Group: 1) CONTROL 0 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Kidney Liver Lung Parathyraid Thyroid -Light(pile)tanin color. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,inimal -Vascularmineralizations,ild Hemorrhage,oultifocals,ild Perivisculasrononucleairnfiltrates,ild -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,MammaryBlind,Pituitary,Adrenal,Trichea, Esophagus,LymphNode (sesenteric)P,ancreas,SalivarySlind,Eye. ---------------------------------------------------------------------------------------- Anisal Number: IR-3527 Sex: Male Group: ( 1) CONTROL0 ppe Fate:(Week= 53) 1 YearInterimSicrifice MacroscopicObservations: MicroscopicObservations: Liver Lung -No visiblelesions. -Portalsononucleacrellinfiltratem,ild Portalbileductproli4trationm,ild -Hemorrhages,ultifocalm,ild The followingtissueswerefoundto be within normallimits: Brain,SpinalCord,Done Narrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, ------------------------------------------------------------------------- -- ---- -- Species:Rat Project Number: 0291CROO12 SumearizedSTAR Page: 2 193 Sus"rizodSingleTabulatedAnimalReport (continued) IndividualMacroscopicand licroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogeniciSttyudy in Rats- One Year Interim ---- -- - ---- ---------------- Table:I Animil Number: IR-3527 Sex: Mall Broup: ( 1) CONTROL0 ppe Fate:(Week=53) 1 YearInterimSacrifice MicroscopicObservations(continued): Thefollowingtissueswerefoundto be withinnormallimits(continued): LargeIntestineU,rinaryBladder,Aorta,Testis/EpididysiPsr,ostate,PituitaryA,drenal, Thyroid,Parathyroid,Trachea,Esophagus,LymphNode (aesenteric)P,ancreas,SalivaryBland,Eye. ------------------------- ----------------- - --- -------- AnimalNumber: IR-3535 Sex: male Broup: 1 1) CONTROL 0 pps Fate:(Weekz53) 1 YearInterimSacrifice MacroscopicObservations: Nesentary MicroscopicObservations: Lung Resentary Parat"roid Thyroid -Areaof fit necrosis2, 1 3 x 0.5co. -Alveolarmacrophigeso,ultifocals,ild Atellectasifso,cal,sild -Necrosis,4at, marked Steatitis,chronic,moderate -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Liver,Kidney,Heart,Stomach,Small Intestine, Large IntestineU,rinaryBladder,Aorta,Testis/EpididysiPsr,ostate,PituitaryA,drenal, Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye, Spleen. --------------------------------------- - --------- --------------- AnisilNumber: JR-3543 Sex: Male Group: 1 1) CONTROL 0 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung -No visiblelesions. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,ild Portilbileductproliferatiofno,cal, minimal -Yascularmineralizationm,iniaal The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Marro*,Spleen,Heart,Stomach,SmallIntestineL,arge Intestine, UriniryBladder,Aorti,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,Lymph Node (mesenteric)P,ancreas,SalivaryBland,Eye. ---------------------------------------------------------------------------------- Species:Rit Project Number: 0291CROO12 Summarized STAR Page: 3-@ 19 4 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924: Two YearOral Toxicity-OncogeniciSttyudyin Rats - One Year Interim ---------------------------------- ----------------- ----------- Table:I - -------------- Animal Number: IR-3546 Sex: Nale Group: 1) CONTROL 0 ppe Fate:(Week=53) 1 YearInterimSacrifice MicroscopicObservations: MicroscopicObservations: Adrenal Liver Lung Stomach -No visiblelesions. -Nodularhyperplasiac,ortex,unilateral, moderate -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Nepatocytaelterationv,acuolitedo,ultifocal, sild -Perivasculasrononucleairnfiltratem,ild -Not examined,missing The followingtissuesmere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Kidney,Heart,Small IntestineL,arge Intestine, UrinaryBladder,Aorta,Testis/EpididymiPsr,ostate,Pituitary,Thyroid,ParathyraidT,rachea, Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBlind,Eye. - ----------------------------------------------------------------------------------------- Animal Number: IR-3550 Sex: Nale Group: 1 1) CONTROL 0 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: Kidney MicroscopicObservations: Heart Kidney Liver Lung Pancreas -Bilateralhydranophrosis -Nyocarditisc,hronicnonsuppurativef,ocal, mild -Hydronephrosisb,ilateral,moderate Calculus,pelvic -Portalmononucleacrellinfiltratem,ild -Vascularmineralizationm,ild -Acinaratrophy,focal,moderate Pancreatitisc,hronic,focal,sild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,DoneNarrow,Spleen,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parathyraid, Trachei,Esophagus,LymphNode (mesenteric)S,alivaryGland,Eye. ---------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 4 19 5 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscapicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FM-3924:Two Year Ural Toxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I ---------------------------------------------------------------------------------------- Animal Number: IR-3551 Sex: Male Group: ( 1) CONTROL 0 ppe Fate: (Week=53) 1 YearInterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Liver Lung -Pale tan -Portalsononucleacrellinfiltrates,ild Portalbileductproliferationmoild -Pneumoniai,nterstitialc,hronic,focal,mild Hemorrhage,oultifocal,mild Hyperplasias,eptalcell,focal,mild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, LargeIntestineU,rinaryBladder,Aorta,Testis/EpididysiPsr,ostate,PituitaryA,drenal, Thyroid,Parathyroid,Trachea,Esophagus,LymphNode lsesenteric)P,ancreas,SalivaryGland,Eye. --------------------------------------------- --------------- ----------------------- Animal Number: IR-3559 Sex:Halt Group: 1) CONTROL 0 pps Fate:(Weekz53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung -No visiblelesions. -Pyelitisa,cute,bilateralm,inimal Nephritisi,nterstitialc,hronic,4ocal, unilateralm,ild -Portalmanonucleacrellinfiltrates,ild Portalbileductproliferationm,ild -Hemorrhages,ultifocal,sild The +allowingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Marro*,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------------------- Animal Number: IR-3568 Sex: Halt Group: ( 1) CONTROL0 pps Fate:(Week= 53) 1 Year InterimSacrifice MacroscopicObservations: -No visiblelesions. MicroscopicObservations: Kidney -Chronicprogressivneephropithya,ild Pancreas -Pancreatitisc,hronic,focal,sild kinar atrophy,focal,mild Parathyroid -Not examined,not in plantof section --------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 5 196 SummarizedSingleTabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FM-3924:Two Year OralToxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I ---------------------------- --------------------------------------------- Animal Number: IR-3568 Sex: Halt Group: ( 1) CONTROL 0 pps Fate:(Neekz 53) 1 YearInterimSacrifice MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Marro*,Spleen,Liver,Heart,Lung,Stomach,StallIntestine, Large IntestineU,rinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal, Thyroid,Trachea,Esophagus,LymphNode (sesenteric)S,alivaryGland,Eye. ---------------------------------------------------- Animal Number: IR-3570 Sex: Kale Group: 1 1) CONTROL 0 pps Fate:(Week= 53) 1 YearInterimSacrifice NacroscopicObservations: MicroscopicObsertations: Adrenal Lung Parathyroid -No visiblelesions. -Corticalvacuolationo,ultifocalm,ild -Pneumoniai,nterstitialc,hronic,focal, minimal Hemorrhage,aultifocal,mild -Notexamintd,not in plantof section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Spleen,Liver,Kidney,Heart,Stomach,StallIntestine, LargeIntestineU,riniryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Thyroid, Trachea,Esophagus,LymphNode toesenteric),Pancreas,SalivaryBland,Eye. --------------------------- Animal Number: IR-3575 Sex: Hale Broup:.t 1) CONTROL0 pps Fate:(Week=53) 1 YearInterimSacrifice MacroscopicObservations: SoftTissues(leg) MicroscopicObservations: Kidney Lung Pituitary -Swollenlefthindfootat thehockjoint. -Chronicprogressivenephropathy,minimal -Yascularmineralizationm,inimal Alveolareacrophageso,ultifocals,ild Hemorrhage,focal,mild -Cyst,parr,distalis The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bone Marro*,Spleen,Liver,Heart,Stomach,SmallIntestine, LargeIntestine,UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Adrenal,Thyroid, Parathyroid,Trachea,Esophagus,LymphNode (mesenteric)P,ancreas,SalivaryBland,Eye. -------------------------------------------------------------------------------------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 6 197 Sumarized SingleTabulatedAnimalRtport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats- One Year Interim --- -- -------------- -------------------- Table:I Animal Number: IR-3580 Sex: Nale group: 1) CONTROL 0 ppe Fate:(Veekz 53) 1 YearInterimSacrifice MacroscopicObservations: Kidney MicroscopicObservations: Bone Narrow Kidney Lung Pancreas Parathyraid Spinal Cord -Darkcysticlesion,0.4co dia.,left. -Not examined,missing -Chronicprogressivenephropathy,mild Cyst,corticalu,nilateral -Alveolarmacrophageso,ultifocal,sild Pneumonia,interstitialc,hronic,oultifocal, sild -Pancreatitisc,hronic,focal,sild -Not examined,not in planeof section -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,Spleen,Liver,Heart,Stomach,StallIntestine,LargeIntestine,UrinaryBladder,Aorta, Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (stsenteric)S,alivaryGland,Eye. ------------- ---------------- ------ ---- - ----------- Animal Number: IR-4578 Sex: Finale Group: ( 1) CONTROL0 pps Fate:(Week= 53) 1 YearInterimSacrifice MicroscopicObservations: MicroscopicObservations: Kidney LymphNode (sesenteric) Parathyraid -No visiblelesions. -Pelvicsineralizationm,inimal -Not examined,missing -Not examined,not in planeof section The followingtissueswere found to be withinnormallimits: Brain,SpinalCard,BoneMarro*,Splm , Liver, Heart,Lung,Stomach,Small Intestine, LargeIntestine,UrinaryBladder,Aorta,Uterus,Ovary,NamearyGland,Pituitary,Adrenal, Thyroid,Trachea,Esophagus,Pancreas,SalivaryGland,Eye. --------------------------------------------------------------------------------------- AnitalNumber: IR-4562 Six:Female group: ( 1) CONTROL0 ppe Fate:(Wetkx 53) 1 YearInterimSacrifice MacroscopicObservations: Mosentiry -Yellownodularmass, I x 0.5 ca. MicroscopicObservations: Heart -Myocarditisc,hronicnonsuppurativef,ocal, minimal Kidney -Calculusp,elvic,unilateral ---------------------------------------------------------------------------------- Species:Rat Project Number: OHICROO12 Summarized STAR Page: 7 198 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-DocageniciSttyudyin Rats - One Year Interim Table:I -- ---- ---------------- -------------------- ---------------------------- Anisal Number: IR-4582 Sex: Female Group: 1) CONTROL 0 ppi Fate:(Week=53) 1 YearInterimSacrifice MicroscopicObservations(continued): LargeIntestine Lung Resentary Parithyraid UrinaryBladder Uterus --Notexamined,missing -Pneumoniai,nterstitialc,hronic,oultilocal, mild Hemorrhage,localareas,sild Perivasculasrononucleairnfiltratem,ild -Necrosis,fat, nodular,moderate Stestitis,chronic,moderate -Notexamined,not in plantof section -Not examined,missing -Hyperplasiag,landularepithelium,sild Metaplasia,squasous,glandular,mild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard, Bone Narrow,Spleen,Liver, Stomach,Small Intestine,Aorta,Ovary, MammaryGland,Pituitary,Adrenal,Thyroid,Trachea,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------- AnimalNumber: IR-45BS Sex: Female Group: 1) CONTROL 0 ppe Fate: (Week= 5-4)1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Kidney Liver Lung Parathyraid -M visiblelesions. -Sinusaidaelctasia,cortex,focal,unilateral, mild -Pelvicmineralizationm,inimal -Portalsonmuclearcellinfiltratem,inimal -Vascularmineralizations,ild Hemorrhage,oultifocal,mild -Not examined,not in planeof section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,MammaryGland,Pituitary,Thyroid,Trachea,Esophagus, LymphNode itesenteric)P,ancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------------ Species:Rat Project Number: 0281CROO12 SuesiriztdSTAR Page: 8 199 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H Ffi-3924T:oo YearOral 7oxicity-OncogeniciSttyudy in Rats- One Year Interim Table:I -------------------------- --------- --- ----------------- --- ------------- ---------- Animal Number: IR-4598 Sex: Female Group: 1) CONTROL 0 ppe Fate:(Week=53) 1 YearInterimSacrifice MacroscopicObservations: Skin Adrenal MicroscopicObservations: Adrenal Kidney Liver Lung Spinal Cord Spleen -Hairloss,neck. -Leftenlarged -Sinusoidaelctasia,cortex,unilateral, marked Corticaldegenerationu,nilateralm,ild -Hyperplasiap,elvicepitheliumm,ild Calculus,pelvic,unilateral Cyst,medullary,sild -Repatacytevacualationo,ultifocal,mild -Hemorrhage,diffuse,moderate -Not examined,missing -Resosiderosisa,ild The fOlIDNinQtissueswere foundto be withinnormallimits: Brain,Bone Narrow,Heart,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder,Aorta, Uterus,Ovary,Mammarygland,Pituitary,Thyroid,Parathyroid,Trachea,Esophagus, LymphMade (mesenteric)P,ancreas,SalivaryBland,Eyeg Skin. ---------------------------------------------------- - --------------------------Animal Number: IR-4599 Sex: Female Group: ( 1) CONTROL0 pps Fate:(Weeiz 53) 1 YearInterimSacrifice MacroscopicObservations: Pituitary MicroscopicObservations: Liver Haseary Gland Parathyroid -Slightlyenlarged -Portalsononucleacrellinfiltratem,ild Portalbileductproliferatioini,ild -Salactocele -Notexamined,not in planeof section The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Spleen,Kidney,Heart,Lung,Stomach,SmallIntestine, LargeIntestine,UrinaryBladder,Aorta,Uterus,Ovary,Pituitary,Adrenal,Thyroid,Trachea, Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 9 00 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I ----------------------------------------------------------------------------------- Animal Number: IR-4590 Sex: Female group: 1) CONTROL 0 ppe Fite:lweekm 53) 1 YearInterimSacrifice MacroscopicObservations: MicroscopicObservations: Lung -No visiblelesions. -Hemorrhage,local areas,moderate The followingtissues*erefoundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Spleen,Liver,Kidney,Heart,Stomach,SmallIntestine, Large IntestineU,riniryBladder,Aorti,Uterus,Ovary,MammaryBlind,Pituitary,Adrenal, Thyroid,Parathyraid,Trachea,Esophagus,LymphNode (mosenteric)P,ancreas,SalivaryGland,Eye. --------------------------------------------------------------------------------------- Animal Number: IR-4601 Sex: Female group: 1) CONTROL 0 ppo Fate:(Week= 53) 1 YearInterimSacrifice MicroscopicObservations: Kidney MicroscopicObservations: Kidney Liver Lung -Hydronephrosisu,nilateral -Hydronephrosisu,nilateral,moderate Calculus,unilateralm,ild -Hepitacytevacuolations,ultifocal,minimal -Hemorrhageo,ultifocals,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinilCord, Bone MarroviSpleen,Heart,Stomach,Small IntestineL,argeIntestine, UrinaryBladder,Aorta,Uterus,Ovary,MasearyGland,Pituitary,Adrenal,Thyroid,Parathyraid, Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryGland, Eye. --------------------------------------------------------------------------------------------- Anisal Number: IR-4608 Sex: Femile Broup: ( 1) CONTROL0 ppB Fate:(Week=53) 1 YearInterimSacrifice MacroscopicObservations: Uterus MicroscopicObservations: Liver Lung Lymph Node (sesenteric) Uterus -Lefthorncysticlookinglesion,I x 0.6 ca. -Nepatocytveacualationo,ultifocalm,inimal -Hemorrhageo,ultifocalm,ild -Not examined,missing -Cysticglands,4ocal,marked The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard, Bone Narrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, LargeIntestine,UrinaryBladder,Aorta,Ovary,MammaryBlind,Pituitary,Adrenal,Thyroid, Parathyroid,Trachei,Esophagus,Pancreas,SalivaryBlind,Eye. --------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 10 21 Suseari2ed SinglTeabulatAendimaRleport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FM-3524:Two Year Oral Toxicity-OncogeniciSttyudyin Rats- One Year Interim Table:I --------------------------------------------------------------------- -------------- Animal Number: IR-4610 Sex: Female Group: 1) CONTROL 0 pps Fate:(Week= 53) 1 YearInterimSacrifice NacroscopicObservations: Pituitary Uterus MicroscopicObservations: Adrenal LargeIntestine Lung Pancreas Parathyroid Uterus -Slightlyenlarged -Slightlyenlarged -Sinusoidaelctasii,cortex,sild -Nisatodiasis -Alveolareacrophageso,ultifocals,ild -Pancreatitisc,hronic,focal,mild -Notexamined,not in planeof section -Hyperplasiag,landularepithelium,sild Netaplasia,squatous,glandular,mild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Spleen,Liver,Kidney,Heart,Stomach,SmallIntestine, L,'rinaBrlyadder,Aorta,Ovary,NasearyGland,Pituitary,.ThyroidT,rachea,Esophagus, LymphMode (sesenteric)S,alivaryGland,Eye. -------------------------------------------------- ------------------ Animal Number: IR-4620 Sex: Female group: ( 1) CONTROL0 ppe Fate:(Week= 53) 1 YearInterimSacrifice NacroscopicObservations: Eye MicroscopicObservations: Eye Kidney Lung UrinaryBladder -Atrophy,righteye. -Panaphthalsitiusn,ilateral,marked Atrophy,unilateralm,arked -Pelvicsineralizationm,inimal -Hemorrhageo,ultifocals,ild -Not examined,missing The followingtissuesmerefoundto be withinnormallimits: Brain,SpinalCard,DoneNarrow,Spleen,Liver,Heart,Stomach,BeallIntestine, LargeIntestine,Aorta,Uterus,Ovary,Namary Bland,Pituitary,Adrenal,Thyroid,Parathyraid, Trachea,Esophagus,LymphMode (sesenteric)P,ancreas,SalivaryBland. ---------------------------------------------------------------------------------------- Animal Number: IR-4629 Sex: Female Group: ( 1) CONTROL0 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: Skin -Hair loss,head,neck,face. MicroscopicObservations: Adrenal -Corticaldegenerationf,ocal,unilateral, mild --- ------------------------------------------------------------- --------- Species:Rat Project Number: 0281CROO12 Su"arized STAR Page:It 202 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations -- RikerLaboratoriesI,nc. 3H FM-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I ------------------------------------------------------------------------------------- Animal Number: IR-4629 Sex: Female Group: t 1) CONTROL0 ppe Fate:(Week=53) 1 Year InterimSacrifice MicroscopicObservations(continued): Aorta Large Intestine Liver Parathyroid -Not examined,missing -Nesatodiasis -Portalbileductproliferatiosni,ld -Not examined,not in planeof section The followingtissues*erefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Kidney,Heart,Lung,Stomach,BeallIntestine, UrinaryBladder,Uterus,Ovary,MammaryBland,Pituitary,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye, Skin. ----------------------------------------------- - --------------------- -- Animal Number: IR-4630 Sex: Female Group: 1) CONTROL 0 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Kidney Liver Lung Parathyroid Thyroid. -Possiblyslightlypalein color. -Calculus,pelvic,unilateralm,oderate -HopatocytoalterationV,aCUDIated,oultifocal, mild -Hemorrhageo,ultifocal,sild -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Ovary,HimearyGland,Pituitary,Adrenal,Trachea,Esophagus, LymphNode (mosenteric)P,ancreas,Salivary61and,Eye. --------------------------------------------------------------------------------------- AnimalNumber: IR-4631 Sex: Female Group: ( 1) CONTROL0 pps Fate:lneeka 53) 1 YearInterimSacrifice MacroscopicObservations: MicroscopicObservationi: Kidney Lung LymphNode (mstnteric) Parathyroid UrinaryBladder -No visiblelesions. -Pelvicmineralizationm,inimal -Hemorrhage,localareas,sild -Not examined,missing -Not examined,not in planeof section -Not examined,missing The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCard,Done Narrow,Spleen,Liver,Heart,Stomach,SmallIntestine, ------------------------------------------------- ---------- --- ---------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 12 203 -- --- SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RittrLaboratoriesI,nc. 3K FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats - One Year Interim -------------------------- Table:I AnimalNumber:IR-46')l Sex: Female 6roup: ( 1) CONTROL0 pps Fate:(Meek-53) 1 YearInterimSacrifice MicroscopicObservations(continued): Thefollowingtissueswerefoundto be withinnormallimits(continued): Large Intestine,Aorta,Uterus,Ovary,Mammary61and,Pituitary,Adrenal,Thyroid,Trachea, Esophagus,Pancreas,Salivary61and, Eye. - ---------------------------------------------- AnimalNumber: IR-4632 Sex: Female 6roup: 1) CONTROL 0 pps Fate:(Week--53) 1 YearInterimSacrifice MacroscopicObservations: Pituitary Mammary 61and MicroscopicObservations: Adrenal Kidney Liver Lung Mammary gland Ovary Pituitary -Slightlyenlargedwith a darkred focuson surface. -Smallsphericalmass, 1.2 ca dia.,containing darkredfluid,leftinguinal. -Sinusaidaelctisia,cortex,focal,unilateral, mild -Chronicprogressivenophropathy,sild -Repatocytveaeuclationo,ultifocal,mild -Hemorrhagee,ultifocals,ild -6alactocele Chronicinflammationand hemorrhagein cysts. -Cyst,unilateral -Adenuma The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Thyroid,Parathyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,Salivary61&nd,Eye. -------------------------------- ---- ------- --- --- --- --------------------------------- Animal Number: IR-4640 Sex: Feeale Group: ( 1) CONTROL0 ppe Fate:(Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Liver Lung Parathyroid -No visiblelesions. -Hipatocytvoacualitiono,ultifocalm,inimal -Hemorrhage,mild -Not examined,not in planeof section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,Mammary61and,Pituitary,Adrenal, Thyroid,Trachea,Esophagus,LymphNode (sesefttericP)a,ncreas,SalivarySlandgEye. --------------------------------------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 13 204 SummarizedSingle TabulatedAnimalRtport IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year O0 ral Toxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I --------------------------------------------- --- --- - - --- -- ----------------- --- Animal Number: IR-3696 Sex:Halt Group: 2) FK-3924 100pps Fate:(Week=53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Liver Parathyroid Stomach -No visiblelesions. -Portalsononucltacrellinfiltratem,inimal Portalbileductproliferationm,inimal Kepatocytevicuolation,localartas,moderate Kegalocytosis,marked Most labulerf,illedwithmarkedlyenlarged htp&tdcytes.Cellsenlargedby increasein volumeof finelygranularcytoplasmwhich displacescoarserorganallesto cell membrane. In some lobulesthereis a gradientof decreasedswellingfrom central to peripheral.Many enlargedcellshave multiplevacuoles. -Not examined,not in planeof section -Not examined,missing The folloningtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Spleen,Kidney,Heart,Lung,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididymiPsr,ostate,PituitaryiAdrenal,'ThyroidT,rachea, Esophagus,LymphNode (sesenteric),Pancreas,Salivary61&nd,Eye. --------------------------------------------------------------------------------------- Animal Number: IR-3699 Sex: Male 6roup, 2) FN-3924 100 ppe Fate:(Weekx 53) 1 YearInterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung Parathyroid Pituitary Spleen Thyroid -No visiblelesions. -Chronicprogressivenephropathy,minimal -Hepitocytveacuolationo,ultifocalm,ild Negalocytosis,@,irked -Yascularmineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, sild Perivasculasrononucleairnfiltrates,ild -Not examined,missing -Cyst,parsdistalis -Heacsiderosiss,ild -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCi)rd,Bone Narrow,Heart,Stomach,SmallIntestine,Large Intestine, ------------------------------------------------------------------------------------- Species:Rit Project Number: 0201CROO12 Summarized STAR Page: 14 205 SusearizedSingleTabulatedAnimal Report (continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FM-3924:Two Year UralToxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I -- --------------------------- Animal Number: IR-3699 Sex: Nalt Group:( 2) FN-3924100 pps Fate:lkeeks53) 1 YearInterimSacrifice MicroscopicObservationslcontinued): Thefollowingtissueswerefoundto be withinnoreallimits(continued): UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Adrenal,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ---------------------------------------------------- Animal Number: IR-3711 Sex: gale Group:( 2) FN-3924100 ppe Fate:(Week= 53) 1 YearInterimSacrifice NacroscDpicObservations: MicroscopicObservations: LargeIntestine Liver Lung -No visiblelesions. -Not examined,missing -Portalsononucleacrellinfiltrates,ild Nepatocytevacualatidno,ultifocalm,ild Regalocytosisw,ked -Perivasculaarmonuclearinfiltratem,inimal The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Spleen,Kidney,Heart,Stomach,Small Intestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,.SalivarGyland,Eye. -------------------------------------------------------------------------------------- Animal Number: IR-3714 Sex: Nale Group: 2) FN-3924 100 ppe Fate:(Weekz 53) 1 YearInterimSacrifice N.icroscopiOcbservations: Liver MicroscopicObservations: Liver Lung Parathyroid Thyroid -Slightlypale,tanish-yellocwolor. -Portalsonanucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld Nepatacytevicuolitiono,ultifocal,moderate Regalocytosis,marked Necrosis,oultifocalm,ild -Vascularsineralizationm,ild -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, Large IntestineU,rinaryBladder,Aorta,Testis/EpididysiPsr,ostate,PituitaryA,drenal, Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBlind,Eye. --------------------------------------------------------------------------------------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 15 206 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FM-3924:Two YearOral Toxicity-OncogeniciSttyudy in Rats- One Year Interim Table:I ------ ----------------------------- ------------- ---------------------------------------- Animal Number: IR-3715 Sex: Male Group: 2) FN-3924 100 ppe Fate:(Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Liver Lung Pituitary SalivaryGland -No visiblelesions. -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Nepatocytveacualitions,ultifocalm,ild Negalocytosis,moderate Necrosis,oultifocalm,ild -Vascularmineralizations,ild Hemorrhage,diffuse,marked -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneMarro*,Spleen,Kidney,Heart,Stomach,Small Intestine, LargeIntestine,UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Adrenal,Thyroid, Parathyraid,Trachea,Esophagus,Lymph Node (mosenteric),Pancreas,Eye. ------------------------------------------------ - -------- ---- ------------------------ Animal Number: IR-3720 Sex: Mile Group: 2) FM-3924 100 ppe Fate:(Meek=53) 1 YearInterimSacrifice MicroscopicObservations: Eye MicroscopicObservations: Kidney Liver Lung Parathyroid Pituitary -Slightatrophyof righteye due to eye bleeding. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,ild Nepatocytovicualations,ultifocals,ild Regalacytosism,ild Necrosis,oultifocalm,ild -Vascularmineralizationm,ild Alveolarmacrophaleso,ultifocal,mild -Not examined,missing -Not examined,missing 'Thefollowingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. --------------------------------------------------------------------------------------- Species:Rat Project Number: 0261CROO12 Summarized STAR Page: 16 207 SummarizedSingleTabulatedAnimalReport lcontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too Year OralToxicity-OncogeniciSttyudyin Rats - One Year Interim -------------------------------- - Table:I - -- --------- Animal Number: IR-3721 Sex: Nale Broup: 2) FN-3924100 pps Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: Eye Skin Liver MicroscopicObservations: Eye Liver Lung Pancreas Parithyroid Thyroid UrinaryBladder -Focalcornealopacityof righteye due to eye bleeding. -Bilateralhairthinning,ventralabdomenand thigh. -Paletan in color. -Keratitira,c,ute,unilateralm,arked -Portalmanonucleacrellinfiltratem,ild Portalbileductproliferatiosni,ld Nepatocytevacualatidn,diffuse,moderate Negalocytosis,marked Necrosiso,ultifocala,ild -Yascularmineralizations,ild -Not examined,missing -Not examined,not in plantof section -Folliculahrywpliisia,cystic,unilateral, moderate -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, LargeIntestine,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Trachea,Esophagus, LymphNode (sesenteric)S,alivary61and. - ----------------------------------------------------------------------------------- Animal Number: IR-3722 Sti:Halt 6roup: 2) FN-3924 100 ppe Fate:(Weekz53) 1 Year InterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Kidney Liver Lung Lymph Node lsesenteric) -Paletan in color. -Chronicprogressivenephrogathy,mild -Portalsononucleacrellinfiltrates,ild Portalbileductproliferationm,inimal Nepatocytevacuolitionc,entrilabular, moderate Negalocytosism,ild -Yascularmineralizationm,inimal Hemorrhage,local areas,moderate -Hemorrhage,mild Hemosiderasisi,iild The followingtissueswe foundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, ------------------------------- ----- --- --- -------------- ---------------------- --- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 17 208 SummarizedSingle TabulatedAnimal Report (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3q24:Two Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim Table: I -------------------------- ------------------ --------------- - ----- ------- ----- - Animal Number: IR-3722 Sex: Halt Broup: ( 2) FN-3q24 100 ppe Fate: (Weeks 53) 1 Year InterimSacrifice MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits (continued): UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Pituitary,Adrenal,Thyroid,Parathyroid, Trachei,Esophagus,Pancreas,Salivary61&nd, Eye. ------------------------------------------------------- ---------------- Animal Number: IR-3727 Sex: Halt 6roup: 2) FN-3924 100 pps Fite: lneek= 53) 1 Year InterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Kidney Liver Lung Parathyroid Testis/Epididymis -Palotan in color. -Chronic progressivenephropathy,minimal -Portalmanonucloacrell infiltrate,vild Portalbile duct proliferationm,ild Nepatocytovacuclation,sultifocal,sild Kegalocytosis,mild -Hemorrhage,local areas,mild -Not examined,not in plane of section -Tubuleatrophy,aspersatogenesis,local areas, sild The followingtissues#ere found to be withinnormal limits: Brain,SpinalCord,Bane Marro*,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta, Prostate,Pituitary,Adrenal,Thyroid, Trachea,Esophagus, Lymph Made (sesenteric),Pancreas,Salivary 6l.and,Eye. ------------------------------------------------------- --- --------------- Animal Number: IR-3732 Sex: Halt 6roup: 2) FN-3924 100 pps Fate: (Week= 53) 1 Year InterimSacrifice MacroscopicObservations: -ft visiblelesions. Microscopic Observations: Liver -Portalmonanucleacrell infiltrate,sild Negalocytosis,moderate Lung -Alveolar"crophages,oultifocal,mild Pneumonia,interstitialc,hronic,oultifocal, mild Hemorrhage,oultifocal,mild Perivascularsononuclearinfiltrate,mild Atellectasisf,ocal,mild Parithyroid -Not examined, missing Thyroid -Not examined,missing ----- -------------------------------------------------------------- Species: Rat Project Number: 0261CROO12 Summarized STAR Page: 18 209 Su"arized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FN-3924:Two Year oralToxicity-OncogeniciSttyudyin Rats - One Year Interim Table:I -- ---------------------------------- ------ -- -------------------------- --- Animal Number: IR-3732 Sex: Hall Group:( 2) FM-P24 100 ppe Fate:lneekx 53) 1 YearInterimSacrifice MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Marro*,Spleen,Kidney,Heart,Stomach,SmallIntestine, LargeIntestineU,rinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal, Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. ---------------------------------------------- -- ---- ----------- Animal Number: IR-3733 Sex: Male Group: 2) FN-3924 100 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung LymphNode (sesenteric) SalivaryGland -No visiblelesions. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,ild Portalbileductproliferatiosni,ld Nepitocytveicuolationo,ultifocals,ild Regalocytosiss,ild -Hemorrhage,local areas,moderate -Not examined,missing -Not examined,missing The followingtissues*erefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,Pancreas,Eye. ------------------------- ----------------- - ------------- Anisal Number: IR-3736 Sex:Rile Group: 1 2) FM-3924 100 ppe Fate:(Weekz 53) 1 YearInterimSacrifice MicroscopicObservations: So4t Tissues(thorax) MicroscopicObservations: Liver Lung Mammary Gland -- ---- ----------------------------- -- -Subcutaneoumsass at thoracicinlet,1.2 ce dia. -Portalmanonucleacrellinfiltratem,ild Portalbileductproliferatiosni,ld Hepatocytveicualationo,ultifocalm,ild Negalocytosis,moderate -Yascularsineralizamt,i mild Alveolarmacrophageso,ultifocal,sild -Adenocarcinosa Largetusw fromareaof thoracicinlet. Highlyanaplasticm,ost tumorcellsin sheets,sootareasof abortiveduct formation.Highsitoticactivity.Local invasion. - ----- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 19 2 10 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FM-3924:Two Year OralToxicity-OncogeniciSttyudy in Rats- One Year Interim Table:I ------------------------------------------------------------------- ------------------- Animal Number: IR-3736 Sex: Male Group: ( 2) FM-3924100 ppe Fate:(Week= 53) 1 YearInterimSacrifice MicroscopicObservations(continued): Parathyraid Pituitary -Not examined,not in planeof section -Adenoma The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Spleen,Kidney,Heart,Stomach,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye, SmallIntestine. - ------------------------------ --------------------- ---------------------------- Animal Number: IR-3737 Sex: Male Group: 1 2) FM-3924 100 ppe Fate:(Weekz 53) 1 YearInterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Kidney Liver Lung Spinal Cord -Slightlytan in color. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,ild Hepatocytevacuolitiono,ultifocal,moderate Regalocytosis,moderate -Yascularmineralizations,ild -Perivisculimkornonucleairnfiltrateg,ild -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,BoneMarron,Spleen,Heart,Stomach,SmallIntestine,Large Intestine,UrinaryBladder, Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,ParathyraidT,rachea, Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ----------------------------------------------------------------------------------------------- Animal Number: IR-3747 Sex: Male Group: 1 2) FM-3924 100 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver -No visiblelesions. -Chronicprogressivenephropathy,mild -Portalmononucleacrellinfiltrates,ild Hepatocytevacuolationo,ultifocal,mild Regalocytosis,moderate Necrosis,iiultifocamli,ld Lung -Hemorrhage,localareas,mild Parathyroid -Notexamined,not in planeof section Testis/Epididysis -Yascularmineralizations,ild -------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 20 SummarizedSingleTabulatedAnimalReport lcontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FM-3924:Two Year Oral Toxicity-OntogeniciSttyudyin Rats - One YearInterim Table:I ------------------------------------------------------------------------------------ Animal Number: IR-3747 Six: Kale Broup:( 2) FN-3924100 pps Fate:(Week=53) 1 Year InterimSacrifice MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,DoneNarrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Prostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ------------------------------------------------- --- -- ---------- ------------------ Animal Number: IR-3748 Sex: Kale 6roup: 2) Ffl-3924100 pps Fate:(Week=53) 1 YearInterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Kidney Liver Lung Parathyroid -Paletan in color. -Chronicprogress;.vneaphropathy,minimal -Portalsononucleacrelliniiltrates,ild Hipatocytevacuolationc,entrilobular, moderate Negalocytosiss,ild Necrosis,4ocal,minimal -Vascularmineralizations,ild Pmwmi,4 ioterstitiaclh,ronic,localareas, sild Perivasculasrononucleairnfiltratem,ild -Notexamined,not in planeof section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Trachea, Esophagus,Lymph Made isesenteric)P,ancreas,Salivary61&nd,Eye. ------------------------------------------------------------------------------------- Animal Number: IR-4757 Sex: Female 6roup: 2) FN-3924 100 ppe Fate;(Week= 53) 1 Year InterimSacrifice MacroscopicObservations: -No visiblelesions. MicroscopicObservations: Kidney -Chronicprogressivenephropithy,mild Liver -Hepatocytveacuolitions,ultifocalm,ild Regalocytosism,ild Lung -Hemorrhage,localareas,moderate Parathyroid -Not examined,not in planeof section Uterus -Metiplasias,quisous,glandular,mild --- --- --- --- -- -- ---------- --- ----------- -- - Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 21 212 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924: Too Year Oral Toxicity-OncogenicitSytudy in Rats - One Year Interim -------------------- ------------------ --- --------------- -- ----------- - Table.,I The followingtissueswere found to be withinnormallimits: Brain, Spinal Cord, Bone Karroo,Spleen,Heart, Stomach,Small Intestine,Large Intestine, Urinary Bladder,Aorta,Ovary, MammaryGland, Pituitary,Adrenal,Thyroid,Trachei,Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryGland, Eye. ------- -------------------------------------------------------------------------- ---- Animal Number: JR-4760 Sex: Female Group: ( 21 FN-3924 100 pps Fate: lkeekz 53) 1 Year InterimSacrifice MicroscopicObservations: MicroscopicObservations: Liver Lung Spleen -No visiblelesions. -Hepatocytevacualation,sultifocal,minimal Negalocytosis,sild -Alveolareacrophages,oultifocal,sild Perivasculamronuclear infiltrates,ild -Hemosiderosis,mild The followingtissuesmere foundto be withinnormallimits: Driin,SpinalCard, Bone Narrow,Kidney,Heart, Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Hastary61and,Pituitary,Adrenal,Thyroid,Parithyroid, Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,SalivaryBlind,Eye. ----------------------------- ------- - --- ----- ---- - - -- --------------- Anigal,Number: IR-4761 Sex: Female Group: 2) FM-3924 100 ppe Fate: (Weekz 53) 1 Year InterimSacrifice Macroscopic Observations: Microscopic Observations: Large Intestine Liver Lung Parathyroid Urinary Bladder Uterus -No visiblelesions. -Nematodiasis -Hopatocytevicuolation,oultifocal,minimal Negalocytosis,minimal -Yascularsineralizationm,ild Alveolarmacrophiges,sultifocal,mild Hemorrhage,sultifocal,sild -Not examined,not in planeof section -Not examined,missing -Metaplisia,squasous,glandular,sild The follomingtissueswere found to be withinnormal limits: Brain, SpinalCard, Bone Narrow,Spleen,Kidney,Heart, Stomach,Small Intestine,Aorta, Ovary, Mammary61and, Pituitary,Adrenal,Thyroid,Trachea,Esophagus,Lymph Node (sesenteric), Pancreas,SalivaryBlind, Eye. ---- ----------------------- --------------------------------------------------- Species: Rat Project Number: 0281CROO12 Sumarized STAR Page: 22 213 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FM-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats- One Year Interim ---------------------------------- Table:I - ------ ------------------------------- Animal Number: IR-4763 Sox: Female Group: 2) FN-3924 100 pps Fate:INeeka 53) 1 YearInterimSacrifice MacroscopicObservations: Skin MicroscopicObservations: Liver Lung Ovary Parathyraid Spleen Uterus -Hair loss,head,neck area. -Portalsononucleacrellinfiltrates,ild Portalbileductproliferationm,ild Nepatocytevacuolitionm,ultifocalm,inimal Mogalocytosis,moderate -Hemorrhage,localareas,moderate -No diagnosis,inadequatesection -Notexamined,not in planeof section -Hemosiderosism,ild -Hydrosetra,moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Kidney,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Mammarygland,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (aisenteric)P,ancreas,SalivaryBland,Eye, Skin. ---------------------- ------- Animal Number: IR-4775 Six: Female BroiLp: 2) FN-3924 100 ppe Fate:(Weeka 53) 1 YearInterimSacrifice MacroscopicObservations: MicroscopicObservations: Liver Lung Mammary Gland Parathyroid Uterus -No visiblelesions. -Hepatocytevacuolationo,ultifocalm,inimal Regilocytosism,oderate Portalbileductproliferations,ild -Alveolarmicrophageso,ultifocals,ild -6&lactocele -Not examined,not in plantof section -Notiplasias,quamous,glandular,sild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, Large Intestine,UrinaryBladder,Aorta,Ovary,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ---------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 23 2 14 SummarizedSingleTabulatedAnimalReport tcontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FM-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats - One Year Interim --------------- - ------------------- Table:I Animal Number: IR-4779 Sex: Female Group: 2) FN-3924 100 ppe Fate:lneek- 53) 1 YearInterimSacrifice MacroscopicObservations: Uterus MicroscopicObservations: Liver Lung Lymph Node (aesenteric) Uterus -Dilatedf,illedwitha cloudyfluid. -Nepatocytvoacualationo,ultifocal,mild Negalocyti)simsi,nimal -Pneumoniai,nterstitialc,hronic,sultifocal, mild Hemorrhageo,ultifocal,sild Perivasculaorononucleairnfiltratem,ild -No diagnosis,inadequatesection -Hydrometra,moderate Endosetritisc,hronic,sild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Marrom,Spleen,Kidney,Heart,Stomach,Small Intestine, LargeIntestine,UrinaryBladder,Aorta,Ovary,Mammary61&nd,Pituitary,Adrenal,Thyroid, Parathyroid,Trachea,Esophagus,Pancreas,Salivary61and,Eye. -------------------------------------- --- -------------- -- --------------------------- Animal Number: IR-4780 Sex: Female Group: 2) FM-3924 100 ppe Fite:(Week= 53) 1 Year InterimSacrifice MacroscopicObservations: MicroscopicObservations: Liver Lung Parathyroid Thyroid -No visiblelesions. -Portalmonanucleacrellinfiltratem,ild Nepatocytevacualationo,ultifocalm,inimal Regalacytosiss,ild -Hemorrhage,local areas,moderate -Not examined,not in planeof section -No diagnosis,inadequatesection The followingtissueswere foundto be withinnormallimits: Brain,SpinilCard,BoneNarrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,MammaryGland,Pituitary,Adrenal, Trichea,Esophagus,LymphMade lsesenttric)P,ancreas,SalivaryBlind,Eye. --------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 24 215 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboritoriesI,nc. 3M FM-3924:Two YearBril Toxicity-OncogeniciSttyudyin Rats- One Year Interim Table: I ----------------------------------- ------- -- ----------- -- - - --- --------- --- -- Animal Number: IR-4782 Sex: Femile Group: 2) FN-3924 100 pps Fate:(kekz 53) 1 Year InterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Liver Spleen -Rightlaterallobe herniatedthroughthe diaphragminto the right thoracic cavity. The lobe withinthe thoraxis mottleddark red. -Nepatocytevacuolition,oultifocal,aild Telangiectisis,moderate Tolingiectasiisn herniatedliverlobe. -He@Dsiderasis, moderate The followingtissueswere found to be withinnormallimits: Brain, SpinalCard, Bone Narrow,Kidney,Heart, Lung, Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta, Uterus,Ovary, hassaryGland, Pituitary,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,Lymph Node (mosenteric),Pancreas, SalivaryBland, Eye. ------------------------------------ -------------------- Animal Number: IR-4783 Sex: Female Group: 2) FII-3924100 pps Fate: (Week= 53) 1 Year InterimSacrifice MicroscopicObservations: Skin MicroscopicObservations: Adrenal Liver Lung Mammary Gland Parathyroid -Small subcutaneousmass, I co dia., behind right shoulder. -Sinusaidalectasia,cortex,focal,mild -Regalocytosis,mild Pigaint,Yupfercell,brown,mild Repitacytevacuolation,sultifocal,aild -Vascularmineralization,mild Hemorrhage,local areas,sild -Adenocarcinoma -Not examined,not in plane of section The followingtissueswere found to be withinnormallimits: Brain, Spinil Card, Bone Narrow,Spleen,Kidney,Heart, Stomach,Small Intestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,Pituitary,Thyroid,Trachea,Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryGland, Eye. ------------------------------------------------------------------------------------------- Species: Rat Project Number: 0281CROO12 Suairized STAR Page: 25 216 SummarizedSingleTabulatedAnimalReport lcontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FK-3q24:Two Year Oral Toxicity-OncogeniciSttyudyin Rats- One Year Interim Table:I ------------------------------------------- -- ------------------------ --- ---------- Animal Number: IR-4785 Six: Female Broup: 2) FN-3q24100 ppe Fate: (Week=53) 1 YearInterimSacrifice MacroscopicObservations: Liver MicroscopicObservations: Esophagus Liver Lung Parathyraid -Slightlpyile -Not examined,missing -Hepatacytevacuolationo,ultifocal,mild Regalocytosism,inimal -Bronchiectasifso,cal,sild -Not examined,not in planeof section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, LargeIntestine,UrinaryBladder,Aorta,Uterus,Ovary,MammaryBland,Pituitary,Adrenal, Thyroid,Trachea,LymphMade (sesenteric)P,ancreas,SalivaryBland,Eye. ----------------------------------------------- - ----------- ------ ---------- Animal Number: IR-4787 Sex: Female Group: 2) FN-3924100 ppe Fate:(Week= 53) 1 YearInterimSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Kidney Liver Lung Pituitary Uterus -No visiblelesions. -Corticildeg'eiiiriitfio'coa"ln,,u'nilateral, mild -Chronicprogressivenephropathy,sild Pelvicmineralizationm,oderate Calculus,Pelvic -Hepatocytveicuolationo,ultifocalm,ild Negalocytosism,ild -Vascularmineralizations,ild -Adenosi -Metaplasias,quisous,glandular,eoderate Hyperplasia,glandularepithelium,moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Ovary,Mammary61&nd,Thyroid,Parathyraid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ----------------------------------------------------------------------------------------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 26 217 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-Onci)genicSittuydy in Rats- One Year Interim Table:I ------------------------------------------------------------------------------------ Animal Nuaber:IR-4788 Sex: Female Broup: 2) FM-3924100 pps Fate:(Weekx 53) 1 YearInterimSacrifice NacroscapicObservations: MicroscopicObservations: Esophagus Kidney .Liver Lung Parathyraid Pituitary Thyroid Trachea Uterus -No visiblelesions. -Not examined,missing -Pelvicmineralizatiosni,ld -Nepatocytveacuolationo,ultifocal,minimal Negilacytosism,oderate -Hemorrhageo,ultifocalm,ild Perivasculasrononucleairnfiltratem,ild Pneumonia,interstitialc,hronic,oultifocal, sild -Not examined,missing -Adoncea -Not examined,missing -No diagnosis,inadequatesection -Metaplasia,squasous,glandular,sild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Ovary,HatearyGland,Adrenal,LymphNode (sesenteric)P,ancreas, SalivaryGland,Eye. ------------------------------------------------------------------------------------- Animal Number: IR-4793 Sex: Female Group: 2) Ffl-3921400 ppe Fate:(Week=53) 1 YearInterimSacrifice MicroscopicObservations: Nesentary MicroscopicObservations: Esophagus Liver Lung Resentary Parathyroid SalivaryGland -Smallnodularmass I x 1.5cm, next to the rightovary. -Not examined,missing -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hepatocytevacualations,ultifocal,minimal Negalocytosis,minimal -Hemorrhage,localareas,mild -Necrosis,4at,nodular,moderate Steatitis,chronic,moderate -Not examined,not in planeof section -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Kidney,Heart,Stomach,Small Intestine, Large IntestineU,rinaryBladder,AortilUterus,Ovary,NammaryBlind,Pituitary,Adrenal, -------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 27 218 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3924:Two YearOral 7oxicity-OncogeniciSttyudyin Rats - One Year Interim ------------------------------------- Table:I - ----- Animal Number: IR-4793 Sex: Female Group: ( 2) FN-3924100 pps Fate:(Neeks 53) 1 Year InterimSacrifice MicroscopicObservationslcantinued): The followingtissuesmerefoundto be withinnormallimits(continued): Thyroid,Trachea,LymphMode (sesenteric)P,ancreas,Eye. -------------------------------- --- - - -- --- -- - Animal Number: IR-4806 Sex: Female Group: 2) FN-3924100 ppe Fate:(Week=53) 1 YearInterimSacrifice MacroscopicObservitionri: MicroscopicObservations: Liver Lung Parathyroid Uterus -No visiblelesions. -Nepitocytveacuolationo,ultifocalm,ild Regalocytosism,ild -Hemorrhage,localareas,mild -Not examined,not in planeof section -Ntaplasia,squamous,glandular,siniaal The followingtissueswere foundto be withinnormallimits: Brain,SpinilCord,Bone Marro*,Spleen,Kidney,Heart,Stomach,SmallIntestine, Large IntestineU,rinaryBladder,Aorta,Ovary,Mammarygland,Pituitary,Adrenal,Thyroid, Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,Salivary.SlandE,ye. ----------------- --------- - - -------- ------ ------ ----- Animal Number: IR-4816 Sex:Fesile Group: ( 2) FN-3924100 ppe Fate:(Meek*-53)1 YearInterimSicrifice MicroscopicObservations: MicroscopicObservations: Liver Lung Parathyroid -No visiblelesions. -Nepatocytveacuolationo,ultifocals,ild Regalocytosiss,ild -Hemorrhageo,ultifocal,sild -Not examined,not in planeof section The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Done Narrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, LargeIntestine,UrinaryBladder,Aorta,Uterus,Ovary,MammaryBland,Pituitary,Thyroid, Trachei,Esophagus,LymphNode (nesenteric)P,ancreas,SalivaryBland,Eye, Adrenal. ------------------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 28 219 SummarizedSingle TabulatedAnimal Report IndividualMacroscopicand MicroscopicDbwvations Riker Laboratories,Inc. 3H FN-'.19"4T:wo Year Oral Toxicity-OncogenicityStudy in Rats --- --------------- Animal Number: IR-3518 six:Nall Fate. (Weeiz106) TerminalSacrifice Broup: 1) CONTROL 0 ppe Table:2 microscopicObservations: Skin MicroscopicObservations: Adrenal Heart Kidney Liver Lung Parithyroid PitL-itary Skirt Thyroid -Raisedinfl&@M lesionn rightrev footpad. -CWtiC&I VICUDIAti0ftUsltifKAI, mild kdullarycellhywplasia, UltifK&I, sild -NYK&rditis,chronicnonsqpurati", local areas, moderate -Dranic progressivem*hropathy, minimal Pelvic mineralization,minimal -PortallOnOnKlearcall infiltratem,inimal Portalbile dact prolifwation,sild -V&Kular aiwalizatim, minimal Peftsonisi,nterstitialc,hronic,OUltifKAI, mild Perivasculamronucltar infiltrate,moderate -Not examined, missing -IW@nosa -Podaderutitis,ulcerative,hindleg,marked -Not examined,missing The followingtissueswere found to be withinnormallimits: Brain, Spinal Cord, Bme Narrow,Spleen,Stomach,Small Intestine,Large Intestine, Uri.,iarByladder,Aorta,Testis/Epididysis,Prostate,Trachea,Esophagus, Lymp@ Mode (sesenteric),Pancreas,Sal4.varyBlind, Eyt. --------------------------- ---- ---- ----- --- ---- --- --- ----------- Animal Number: IR-3519 Six: Halt Broup: 1) CONTROL 0 ppe Fite: (Week-1-06) TerminalSacrifice MacroscopicObservations: -No visiblelesions. Microscopic Observations: Adrenal -ginvsoidalectisia,cortex,oultifocal,mild Esophagus Heart Kidney Liver CorticalVKU01ati0fio,ultifocals,ild -Not examined,aisting -Nyocarditis,chronicnonsuppurative, oultifocals,ild -Chronicprogrtssivenophrop&thy,sild -Portalemosuclearcell infiltratem,ild PortalbiledKt proliferationm,ild -- -- -- -------------- N"&tKytt alterationv,atoolated,aultifocal, mild - -------- .4go trioAj*LMACO-MC-C@OIC-(Zb3WAV0474" : 7-*IA.4ArSlo#VMRALW 44,Uas.SP.A4.7x'31j LLoL RMOSA). Ct@o@46 -YI-flAr SpecieRsa:t Project Number: 0281CROO12 Susw ized STAR Page: 29 220 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-WcogenicitSytudyin bts Table:2 Animal Number: IR-3519 Six:Nale Sroup: 1) CONTROL 0 ppe Fate: (Neekz106)TerminalSacrifice MicroscopicObservations(continued): Lung -Vascularmineralizationm,ild Perivisculasrmanuclearinfiltratem,oderate Pneumonia,interstitialc,hronic,*UltifKAI, moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,DoneNarrow,Spleen,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididymiPsr,ostate,Pituitary,Thyroid,ParathyroidT,rachea, LymphNode (mosenteric)P,ancreas,SalivaryBlind,Eye. Animal Number: IR-3521 Sex: Nile Broup: 1) MNTROL 0 ppe Fate:(Weeks 92) Sacrificeidn extresis MicroscopicObservations: Skin Liver Spleen MicroscopicObservations: Adrenal Heart Kidney Liver Lung Parathyroid Skin Spleen Stomach -Bothhind footpidsulcerated. -Pall -Enlarged -CorticalVACOOlitiOn,l@ocal areas,sild Medullarycallhyoirplasia,UltifK&I, mild -Myocardialfibrosis,@UltifK&I, sild -Chronicprogressivenephropathy,moderate -Hipatocytveicuolationc,entrilobular, moderate -Vascularmineralizationm,ild Pneumonia,interstitialc,hronic,localareas, mild Edema, localareas,sild Fibrosisp,leural,sild Thrombus -Notevisined,missing -Pododereatitisu,lcerative,hindleg,marked -Himatopoiesise,xtraeedullaryi,ncreased, moderate -Edoma,subwcosal, marked Thefollowingtissuesare foundto be withinnormallimits: Brain,SpinalCord,Boat Narrow,SmallIntestine,LargoIntestine,UrinaryBladder,Aorta, Testis/EpididysiPsr,ostate,Pituitary,Thyroid,Trachea,Esophagus,LymphNode (sesnteric), Pancreas,SalivarySland,Eye. -- - -- --- -- Species:Rat ProjKt Number: 0281CROO12 Summarized STAN Page: 30 221 SummarizedSingleTabulatedAnioalReport (continued) IndividualMicroscopicand NicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncogenicityStudy in Rats Table: 2 Animal Number: IR-3523 So: Nale Group: Fate: (Week= 95) Sacrificedin extresis 1) CONTROL 0 ppe Nacroscapic Observations: SoftTissues (thorax) Stomach MicroscopicObservations: Adrenal Heart Kidney Liver Lung Prostate Skin Stomach -Ussl 10 1 9 1 4 ce in left axilleinvolving muscleand rib, extendinginto leftthoraciccavity,collapsingleftlung. Miss soft ad fatty. -NalledematousNith possibleulcerationin cardia. -Corticalvacuolationl,UltifKAI,mild ginusoidalectisia,cwtes, diffuse,mild -NYK&rdialfibrosis,@UltifK&I, mild -Chronicprogressivenophropathy,mild -Pwtal ooo=ecleartellinfiltrates,ild Portalbile ductproliferations,ild Repatocytealteration,vicuolated,sild -Vascularmineralizationa,ild Hemorrhage,focal,sild Alveolarmacrophiles,sild -Prostatitis,acute,suppurative,marked -Fibrosarcosa,tbwaz:, @c,- @ . @ Nalldifferentiatedh,ighlytollularwith moderate collagen formation. -Ulcer,&irked The followingtissuesNero found to be within noreiklimits: Brain,SpinalCord, Bone Narrow,Spleen, Small Intestine,Large Intestine,Urinary Bladder, Aorta,Testis/EpididysisP,ituitary,Thyroid,Parathyroid,Trachea,Esophagus, Lymph Node (sesenteric),Pancreas,Salivarygland,Eye. ---------------- - --- -------------------- - Animal Number: IR-3524 Sex: Nale Group: 1 1) CONTROL 0 pps Fate: (Weeks106) TerminalSacrifice MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Large Intestine Liver -- - -------- -Smallred lesion. -Medullarycell hyperplasiao,ultifocal,sild -Chronic progressivenophropathy,moderate Pelvicmineralizationm,ild -Weatodiasis, colon -*&tKyte alteration,vacuolated,moderate Portalmonuclear cell infiltratem,ild Pwtal bileduct proliferationm,ild Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 31 222 SummarizedgiftliTtabulatedAnimalReport leontinuw) ladividualMicroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Tomicity-CkcogenicitSytudy in Rats Table:2 AnimalNumber: IR-3524 Be%: Nale Group: 1) CONTROL 0 ppe Fate: (Weeks106)TerminalSacrifice MicroscopicObservations(continued): Lung Lymph Node lsesimteric) Pirathyroid Pituitary Thyroid -Yascularmineralizationm,ild -Not nasined, missing -Hotexamined,not in planeof section -Adenosa 4ollicularhyperplasiac,ystic,umilateral, moderate Largecysticlesionoccupyingsuch of one thyroidlobe. The follovingtissueswere foundto be vithinnormallimits: Brain,SpiA&lCord,lone Marro*,Splm, Heart,Stomach,StallIntestintoUrinaryBladder, Aorta,Testis/EpididysisP,rostate,Trachea,Esophagus,Pancreas,SalivaryBland,Eye. Aniul Number: IR-3525 Sti:Halt Group: 1 1) CONTROL 0 pps Fite: (Weeks106)TerminalSacrifice MacroscopicObservations: Bone Liver MicroscopicObservations: Adrenal Done Heart Kidney Liver Lung Parathyroid SPIm Testis/Epididysis -Jointso4 rightforelimbandrighthindliab svol -Raisedpalecircularlesion,2 ce dia.,in mediallobe. -Corticalvaccolationl,ocalareas,moderate -Arthritiss,ynovitisj;oints,foreleg, hindleg,marked -Nyocarditisc,hronicnonsuppurative, localareas,sild -Chronicprogressivenephropathy,moderate -Portalmnonuclearcellinfiltrates,ild Portalbileductproliferations,ild Hepatocallularcarcinoma Large,poorlydifferentiateda,naplastic, infiltrativeA.denoidareas.Multipletumor eaboliin lung. -Yascularmineralizations,ild Metastaticneqlasa -Nottxaoined,met in plantof section -Hemosideresism,ild -Tubuleatrophy,aspersitogtnesism,ild Thefollovingtissueswre foundto be vithinnormallimits: Brain,SpinalCord,Bme Norrco,Stomach,6"11 IntestineL,arge IntostintU,rinaryBladder, Species:Rat Project Number: 0281COO12 Summarized STAR Page: 32 223 SummarizedSingleTabulatedAnimalReport (continued) Individualkcrescopiacnd MicroscopiOcbservation RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-ftcogeniciSttyudyis Rate Table:2 Animal Number: IR-3525 Sex: RAle Group: ( 1) CONTROL0 ppe Fate: (Weeks106)TerminalSacrifice MicroscopiOcbservation(scontiNued): Thefollowingtissueswerefoundto be withinnorul limits(continued): Aorta,Prostate,Pituitary,Thyroid,Trachei,Esophagus,LymphNode imenteric), Pancreas, SalivarySland,Eye. - --- - --------Animal Number: IR-3526 Sex: Male Broup: 1) CONTROL 0 pps Fate: (Weeks106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung -No visiblelesions. -Chronicprogressivenephropathy,mild -Portalsononuclewcell infiltrates,ild Portalbileductproliferatiosni,ld Cystaiddegeneratiofnk,al, mild Hep&tKytoalterationv,kuolated,sild -Yascularmineralization,mild The followingtissueswere fatmd to be within weil limits: Brain, SpinalCord, Bat Narrow, Splm, Heart, Stomach,Small Intestine,Large Intestine, Urinary Bladder,Aorta, Testis/Epididysis,Prostatel Pituitary,Adrenal,Thyroid,Parithyraid, Trachea, Esophagus, Lymph Node (sesenteric),Pancreas, Salivary 61od, Eye. Anisal Number: IR-3328 Sex: Kale Fite: (Weeks 106) Terminal Sacrifice Group: 11 CONTROL 0 ppe Macroscopic Observations: Kidney Microscopic Observations: Adrenal Kidney Liver Lung Pituitary -Hydronephrosis -Corticalvocualition,4ocal, sild -Chronic progressive nephropathy, moderate Hydranophrosis,unilatwal, moderate -Portalsononuclearcell infiltrate,mild Pwtal bile duct proliferation,sild HopatKytt V&CUCI&tiOD,mitifocal, sild -Yascularmineralization,wild Ponmia, isterstitialc,hronic,fUltiiK&I, sild -Hyperplasia,fK&I, pars distalis,sild The followingtissueswe found to be vitkin normal limits: Drain, Spinal Cord, Done Narrow, Splm, Heart,Stmckg Small Intestine,Large latestinig Urinary Bladder, Aorta, Testis/Epididysis,Prostate, thyroid, Parithyroid,Trachea, Esopkaggs, - -- --- ---- Species: Rat Project*A6er: ONICM12 Swevized STAR Pop: 33 224 SmariztdSinglTeabulateAdnimaRleport(cotinved) ledividuMaalcroscopoiWcMicroscopDikcwvations RikeLraboratorIinecs.,3N FN-3t24T:ooYearOralToxicity-bcognicSittuydyinRats Table2: AnimaNlumberI:R-3529 Sex:PAI@ Broup:(1)CONTRO0Lppe Fate:(Netk1x06)TerminaSlacrifice MicroscopOibcservatio(ncsontinued): Thefollowitnigssuewserefoundtobewithinnormallimits(contioutd): LymphNode(sesenteriPca)n,creisS#alivarBylindE,ye. AnisaNlumberI:R-3529 Sex:Kale Broup:1)CONTRO0Lppe Fit@:(Week.s96)Sacrificiendextresis MacroscopOibcservations: Skin Liver MicroscopOibcservations: Adrenal Kidney Liver Lung Parathyroid Prostate SalivarGyland Skin UrinarByladder -Areaosfdereatitwiisthhairloss,some scabbedb;ack,side,abdomen. -Raisepdalemass,1.2cedia.inlt4tlateral lobe. -CorticvaalcsoliitiUolnt,ifKal, sild -Chrcoipcrogressinveepbropathsyi,ld -Portaelmmuclearctllinfiltratsei,ld NtpitK#Ilularcarcinoma Trobeculpaartternf,airlwyll differentiated. -Vasculmairntralitatimmi,ld Edna,subpleuramlo,derate -Notek&ainendo,tinplantofsection -bt examinemdi,ssing -Notexaminemdi,ssing -Ulcerb,ack,abdomenm,arked -Epithelihaylperplasisai,mpled,iffusem,ild Thefollowitnigssuewserefoundtobewithinnormallimits: BrainS,pinaClord,BaneKarrooS,pleenH,eartS,tomachB,eallIntestinLea,rgeIntestine, AortaT,estis/EpididyPsiitsu#itarTyh,yroidT,racheaElsophaguLsy,mphNode(sesenteric), PancreaEsy,e. ------------------------ AnimaNlumberI:R-3530 Sex:Halt 6roup:1)CONTRO0Lpps Fite:(Week1s06)TerminaSlacrifice MicroscopOibcservations: MicroscopOibcservations: Heart Kidney Liver -Novisiblleesions. -KyKarditis,chronicnonsuppurativeF,KAI, minimal -Chronicprogressivenephropithylsild -Portamlonuclearcallinfiltratsei,ld Portalbile ductproliferations,ild Cystoidd"imeration,focil,moderate PAP&tKytt alteration,vacoolitedlmild Species:Rat ProjectNumber:0281CROO12 &mwized STARPage: 34 225 SummarizedSingleTabulatedAnisalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year OralTaxicity-ftcagecniityRudy is bts Table:2 AnisalNumber: IR-3 Six: Kale Group: 1) CONTROL 0 pps Fate: (Wtekz106)TerminalSacrifice MicroscopicObservations(continued): Lung SPIM -Yascularmineralizations$ild Paribronchialymphoidhyperplasia,mild -Newsiderosisgmild The follovingtissueswre foundto be vitbinnormallimits: Brain,SpinalCard,Bone Rarrov,Stomach;Small Intestine,LargeIntestine,UrinaryBladder, Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,ParithyroidT,rachea, Esophagus,LymphNode (wsenteric),Pancreas,SalivaryGland,Eye. Animal Number: IR-3531 Sex: Nale Broup:1 1) COM Fate: (Weeks106)TerminalSacrifice 0 ppe MicroscopicObservations: MicroscopicObservations: Kidney Liver Lung -M visiblelesions. -Chronicprogressivesephropithy,mild -HepAtOCytVtKUOI&tiOn,wltifocal,sild Portalsmansclearcellinfiltratem,inimal -Yascularmineralizationm,ild Pneumoniai,sterstitialc,hronic,localareas, moderate The folloningtissuesNere foundto be mithinnormallimits: Brain,SpinalCord,BoneNarrovlSplm, Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,LymphNode (ountiiric),Pancreas,SalivarySliindE,ye. AnimalNumber:IR-M2 Sex: Nale Broup: 1) CONTROL 0 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Pituitary Kidney MicroscopicObservations: Eye Heart Kidney Liver Long -Raisedred &ass,0.4 ce dia. 4luid filledcyst,I ce dia.,in rightkidney -Retinalatrophy,focal,mild -Myocardiaflibrosis,fK&I, sild -Chronicprogressivenephropathy,moderate Cyst, cortical,marked -Portalsononucliicaerllinfiltrates,ild Portalbileductproliferatiosni,ld -Yoscularmineralizationm,ild Pnememia,interstitialc,hronic,lVltifK&I, mild keorrhage,localareas,sild Perivasculemonucloar infiltrates,ild species:Rat Project Number: 0291CROO12 kowized STAR Page:35 226 Bumrized SingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesIlnc. 3H FN-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 AnimalNumber: IR-3532 Sex: Kale Group: 1) CONTROL 0 ppe Fate: (Vffka106)TerminalSacrifice MicroscopicObservations(continued): Lymph Node (sesenteric) Pituitary spleen -Hemorrhage,sild -Adenm -Nuosiderosis,mild The folloving.tissuewsere foundto be withinnormallimits: Brain,SpinalCorirgBoat Narrow,Stomach,SmallIntestine,Large IntestineU,rinaryBladder, Aorta,Testis/EpididysisP,rostate,Adrenal,ThyroidlParithyroidT,rachea,Esophagus,Pancreas, SalivaryGland. --------- -- Animal Number: IR-3533 Six: Kale Group: 1) CONTROL 0 ppo Fate: lneek-1-06)TerminalSacrifice MacroscopicObservations: Spleen MicroscopicObservations: Eye Heart Kidney Liver Lung Prostate Spletn -Palocirculardepressedarea,0.4 co dia. -No diagnosis,inadequattsection -"arditis, ckronicnmsupptirativel @UltifKalllild -Chronicprogressivenephropathy,mild -Portalsononucleacrellinfiltratem,ild Hepatocytevkiiolation@,UltifK&I,sild -Vastalaariwalization,mild Pneumoniai,nterstitialc,hronic,lUltifK&I, mild Perivasculasrononucleairnfiltratem,ild -Prostatitisa,cute,suppurativem,ild -Onosiderosis,mild Fibrosis,localareas,moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder, Aorta,TestistEpididysiPsi,tuitary,Adrenal,Thyroid,ParithyroidT,rachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland. - - --- ------------- -- AnimalNumber: IR-3534 Sex: Halt Group: 1) CONTROL 0 ppe Fate:(koks 105)Sacrificeidn extramis MacroscopicObservations: Thymus Pancreas -&I arged -Massivebeigicoloredmass,7.5 s 3 ce in ariaof pacrtis completely wrmding splm aidadberiatlo posterior artisof rightandliftlateral Species:Rat ProjectWar: 0281CH012 Smarized STAR Page:36 227 Sumarized SingleTabulatedAnimalReport (catinued), IndividualNacroscopicand NicrescopicObservations RikorLaboratoriesI,nc. 3N FN-3924:Two Year OralToxicity-OncogeniciSttyudyis Rats Table:2 Animal Number: IR-3534 Sex: Kale Group: 1 1) CONTROL 0 ppe F,ite:lneeks105)Sacrificeidn extruis NacroscopicObservations(continued): Pancreas (continued) Kidney Testis/Epididysis Li-vor NicroscopicObservations: Adrenal Kidney Liver Lung Lyaph Node (sesenteric) Pancreas Parathyroid Pituitary SmallIntestine SPIM Stomach Testis/Epididysis Thymus Thyroid UrinaryBladder -liverlobes. -Paleand pitted. -Righttestissmall. -Palewithyellowishcircularlesion0.3 cm diameterin rightanteriorlobe -Corticalvacuolitiondgiffuse,moderate Nedullarycellhyperplasia,localareas, moderate -Chronicprogressivenephropathy,moderate NaligOintlylPhOl&,hiStiKytiC -HWtKYtl vicooliktiodni,ffuse,wked -Hemorrhage,diffuse,marked NalignantlYq*OlAg hiStiKYtiC -Hemorrhage,mild PAlignanltym*ul hiStiKytiC -Naligftanltyfipho&ah,iStiKytiC -Not examined,missing -Menosa -Nalitflafllyt@PhOS9,hiStiKYtiC -NaligY4ntIY@PhOla,hi$tiKYtiC -klignantlyspholdh,istiocytic -Tubuleatrophylaspereatagenesisulnilateral, awked -MlignafttlYMPhOgi,hiStiKYtiC Rultiplesectionsof tumorfromthymicand udiastinalareas. -Mt examined,missing -Nalignantlymphosa,histiocytic The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard, Done Narrow,Heart,Trachea,Esophagus,SalivaryBland,Eye, LargeIntestine,Aorta,Prostate. Species:Rat ProjectNu@W: 0281CM12 Smikrized STAR Page: 37 228 SumarizeSdinglTeabulatAendimaRleport(continued) IndividuNaalcroscopaincdRicroscopOibtservations RikeLraboratorIinecs.,3N FN-3t24T:woYew OralToxicity-OncolenSitcuidtyiynbts Table2: AnimaNlumberI:R-3536 Six:Kale Group: 1)CONTRO0Lpps Fate:(Nnkz106)TerminaSlacrifice MacroscopOibcservations: Skin MicroscopOibcservations: Adrenal Kidney LargeIntestine Liver Lung Skin -Raiseldesion1,.5cedia.,appeartsobe abscess. -Corticvaalcualatio4no,calm,ild Sinusoidaacltaia,cortexf,ocalm,oderate -Chronipcrogressinvoephropatmhiyn,imal -Nesitodiasciosl,m -Portablileductproliferati@oUnl,tifKalg mild Porta9l000OKlear cellinfiltratsei,ld *&tkytt VKBOIAtiOR@,UltifKAIm,inimal -Vasculasrintralizatimoinl,d Periviscusloanronucleianrfiltratmei,ld -Kwatoacanthoma Raiseldesiofnromback. Thefollowitnigssuewserefovndtobewithinnormalimits: BrainS,piniClord,Bot NarrowS,pleenH,eartS,tomachS,malllattstinAiogrta, Testis/EpididyPsrios,tatPei,tuitarTyh,yroidP,rathyroiTdr,acheaE,sophagus, Lymphkode(sesenteriPca)n,creaSsa,livarBylindE,ye,LirirtBalraydder. -- --------- AnimaNlumberI:R-3537 Six:Kale Group: 1)CONTRO0Lppe Fate:(Metka73)FoundDead MacroscopOibcservations: Liver LymphNode(abdominal) Abdome(ninternal) Pituitary MicroscopOibcservations: Eye Heart Liver Lung LymphNode (K@mteric) Pancreas Pwathyroid -Verypale -Renallymphnodesenlarged. -kltilobulafrl,esh@yass,4 s 3.5x 3.5 attachetdoowtue, leftinguinal area. -Nmrrhagimcass,0.7cedia. -*t examinemdi,ssing -Malignalnytaphoshai,stiocytic -W*atocytvoacuolatiodni,ffusee,arked Malignanltynoosah,istikytic -Mlignanltyaphnah,i$tiKytiC HemorrhagIeK&,I areasm,oderate -Not examined,missing -Not examined,missing -Not examindl missing Species:Rat ProjectNumber:OnICW12 &mwized STU Page:n 229 Smearizod SingleTabulatedAnimalReport(continued) IndividualNacroKopic and MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3124:Two Year OralToxicity-NcogenicitSytudyin Rats Table:2 AnimalNumber:IR-= Sex: Nale Fate: (Neeka 73) FoundDead 6roup: 1) CONTROL 0 ppe MicroscopicObservations(continued): Pituitary Skin Spleen Thyroid -Adenma -Malignantlymphoma,histiocytic Mass from inguinalarea was malignant lyaphosa. Therewas extensivenecrosisin tumor. -Ramosidernis,sild -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Kidney,Stomach,Small Intestine,LargeIntestine, OriniryBladder,Aorta,Testis/EpididysiPsr,ostate,Adrenal,Trachea,Esophagus,SalivaryGland. --- --- -------- ----------------- --- ---- - ------ Anisal Number:IR-353B Sex: Nale Sroup: 1) C(N(TRUL0 ppe Fite: (Veekz106)TerminalSacrifice NacroscopicObservations: Pituitary Liver Spleen MicroscopicObservations: Adrenal Kidney Liver Lung LymphNode (sesenteric) Parithyroid Prostate Spleen UrinaryBladder -Smallhemorrhagicarea,0.2 co dia. -NUItiPIOPilefoci,All lobes. -@Enlirget -Corticavlicuolationf,ocal,mild -Chronicprogressivesephropathy,sild -Malignanltyophoiiih,istiocytic -Yascularsineralizatiosni,ld Alveolareacrophages,mild Malignantlyapkoea,histiocytic Periv&Kularsononucleairnfiltratem,ild -Hemorrhage,minimal -Not examined,not in plane04 section -Prostatitis&,cuts,suppurativem,arked -NAligft&nltybph0l&,hiStiKYtiC -Epitheliahlyperplasias,imple,diffuse,mild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Marro*,Heart,Stomach,Bull Intestine,LargeIntestine,Aorta, Testis/EpididysitP,ituitary,Thyroid,Trachea,Esophagus,Pancreas,SalivarySlaW, Eye. -- -- - --------------- Species:Rat ProjiictNumber: 0281CROO12 Smarized STAR Page: 39 230 SumrizedSinglTeabulatAendimaRleport(continued) IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3H FN-3q24T:woYtirOralToxicity-OncogenSitcuidtyiynRAts Table2: AnimaNlumberI:R-3539 Sex:Kale Group:1)CONTR0OLppe Fate(:Neek1m06T)erminSaalcrifice MicroscoOpbiscervations: MicroscoOpbiscervations: Kidney LargIentestine Liver Lung Parithyroid Pituitary Spleen Thyroid -Novisible sions. -Chronpircogressnievpehropatshiyl,d -Nnatodialciosl,on -Portsaolnonuclceealrlinfiltramtiel,d Hipatocvyatceuolatisounl,tifocmaill,d -Vasculsairneralizastilodn, Pneumoniinat,erstitciharlo,nimcu,ltifocal, mild Perivascusloanronuclienafriltrastiel,d -Notexaminendo,tinplanotfsection -Cystp,arsdistalis -Hmsiderossiisl,d -Ultisabranccyhsital Thefollowitnigssuewserefountdobewithinnormallimits: BrainS,pinaClordB,oneNarrowH,eartS,tomacBhe,alIlntestiUnrei,niBrlyaddeAro,rta, Testis/EpidiPdryossitsa,tAed,renaTlr,acheEis,ophagLuysm,pNhode(sesenterPiacn)c,reas, SalivaGrlyandE,ye. ------------- -- -- ------ AnimaNlumberI:R-3540 So%:Male Group1:1)CONTRO0Lppe Fate:(Week=64)FoundDead MicroscopOibcservations: MicroscopOibcservations: BoneNarrow Liver Lung Prostate SpinaClord Thyroid UrinarByladder -k visiblleesions. -Notexaminemdi,ssing -Portamlnanuclecaarllinfiltratmei,ld Portablileductproliferatimoinl,d -Vasculsairnerilizatsiiolnd, Alveolasracrophigseisl,d -Notexaminemdi,ssing -Notexaminemdi,ssing -Ultimcbrancchyisatl -Notexaminemdi,ssing Thefollowitnigssuewserefoundtobewithinnormalimits: BrainS,pleenK,idneyH,eartS,tomachB,ullIntestinLea,rgeIntestinAeo,rta, Testis/EpididPyistiusi,tarAyd,renalP,arathytoTirda,cheaE,sophaguLsy,mpNhode(sesenteric), PancreaSsa,livarGylandE,ye. SpeciesR:at ProjecNtumberO:nICM12 SUGW i2ed STARPage:40 231 SuairizodSingleTabulatedAnimalReport leontinved) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-M4: Two YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3541 Sex: Nale Group: 1 1) CONTROL0 ppe Fate:(kek- 106)TerminalSacrifice MicroscopicObservations: Skin MicroscopicObservations: Adrenal Kidney Liver Lung Prostate Skin Testis/Epididysis LlrinarByladder -Raisedlesionon leftrearfootpad. -Corticalvacualationfsocal,sild Sinusoidalectasia,cortex,minimal -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld -Vascularmintralizatimm,ild Pneumonia,interstitialc,hronic,oultifocal, mild Hemorrhage,diffuse,marked Perivasculawrnonuclearinfiltrates,ild -Not examined,missing -Podedersatitisu,lcerativeh,indleg,@irked -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,lone Marro*,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, Aorta,Pituitary,Thyroid,ParithyroidT,rachea,Esopbaqus,LymphNode (sesenteric)P,ancreas, SalivaryGland,Eye. --- --------------- ---- - Animal kumber:IR-3542 Six: Nale Group: 1 1) CONTROL 0 ppe Fate: (Meek-106) TerminalSacrifice MacroscopicObservations: Testis/Epididysis MicroscopicObservations: Kidney Liver Lung Lymph Node (sesenterit) Pancreas Testis/Epididysis Thyroid -bothtestesmall. -Chronicprogressivenephropathy,moderate -HWtacyto vacuclationo,ultifocals,ild -Vascularsintralizationm,inimal -Nnorrhage,minimal -Hyperplasiai,sletcell,moderate -Tubuleatrophy,aspereatogenesisb,ilateral, marked Polyirteritissi,ld -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Prostate,Pituitary,Adrenal,ParathyroidT,rachea,Salivary6landgEye, Esophagus. - - --- --- --- - - -- --- --- Species:Rat Project kmber: OHICROO12 Snearized STAR Page: 41 232 Sumarized SingleTabulatedAnimalReportttontinued) IndividualMacroscopicand RicroicopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogenicitSytudy in Rats Tablt:2 Animal Number: IR-3544 Sex: Nale Group: 1 1) CONTROL 0 ppe Fate: (Neeka106)TerminalSacrifice MicroscopicObservations: Pituitary Kidney Testis/Epididysis MicroscopicObservations: Adrenal Kidney Liver Lung Pancreas Parathyroid Pituitary Spleen Testis/Epididysis -Hemorrhagilcesion,0.7 ce dial -Bothenlarged,pale and pitted. -Lefttestissmall. -Corticalvacualition,oultifocal,moderate Sinusoidalectasia,cortex,moderate -Chronicprogressivenephropithy,&irked -Nepitocytveacuolitiono,ulti4ocals,ild -V&Kularsineralizatiotni,ld Alveolar macrophagesgmild -kinar atrophy,sild Polywteritis,moderate -Not examined,not in planeof section -Adenou -Mmsiderasis,mild -Tubuleatrophy,aspermatcqenesiusn,ilateral, marked Polyarteritism,arked The followingtissueswerefoundto be withinnormallimits: Brain,SpinilCord,Bonehirron,Stomach,Ss4kllIntestine,LargeIntestine,UrinaryBladder, Aorta,Prostate,Thyroid,Trachea,Esophagus,LymphNode (sesenteric)S,alivarygland,Eye, Heart. ----------------------------Animal Number: IR-3545 Sex: Kale Group: 1) CONTROL 0 ppe Fate: ineekz104) FoundDead MicroscopicObservations: Skin Liver MicroscopicObservations: Adrenal Eye Heart Kidney Lung Pancreas Pituitary -Circularlesions,2.5 ce dia.on bothhind footpids. -Slightlypale -Sinusaidalectasia,cortex,moderate Corticalvacuolationo,ulti4ocalm,oderate -Not examined, missing -Myocardial fibrosis, local areas, sild -Chronic progressive nephropathy, mild -Yascularsineralizationsgild Alveolar"crophages,mild -Acinaratrophy,moderate -4wencea Species:Rat ProjectNumber:0281CROO12 SumarizedSTARPage:42 233 Suairized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand RicroscopicObservations RikerLaboratoriesI,NC. 3N FN-3924:Too YearOral Toxicity-WcogenicitSYtudyin Rats Table:2 Animal Nuaber: IR-3545 Sex:Halt Group: 1) CONTROL 0 ppe Fite: (Week=104) Found Dead MicroscopicObservations(continued): Skin Spleen -Pododereatitiusl,cerativeh,indleg, bilateral,marked -Hematopoiesise,xtrisedullaryi,ncreased, sild The followingtissues*erefoundto be withinnormallimits: Brain,SpinalCord,BaneNarrow,Liver,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Thyroid,Parathyroid,Trachea,Esophagus, LymphNode (sesenteric)S,alivaryGland. - -- -- --- - Animal Number: IR-3547 Sex:Kilt Group: 1) CONTROL 0 pps Fate:(Meek= BS)Sacrificedin extresis MicroscopicObservations: Pituitary Liver MicroscopicObservations: Adrtnal Brain Kidney Liver Lung Pituitary Stomach -Mass,0.4 co dis. -Pall -Sinvsoid&lKtAgii, cortex,moderate -Oligodendrogliossb,enign Largtneoplasmcomposedof large,fairly uniformpolyhedralcellsin cerebralcortex. -Chronicprogressivenophropithy,minimal Pyelonephritisaocute,mild -Portalsononucleacrellinfiltrates,ild RepitDcytevicualitionp,oriportilm,oderate -Yascularmineralizationm,ild -Adenosa -Edema,subsucoul, moderate The followingtissueswert foundto be withinnormallimits: SpinalCard,BoneKarroo,Spleen,Heart,SmallIntestine,LargeIntestine,UrinaryBladder, Aorta,Testis/EpididyeiPsr,ostate,Thyroid,ParithyroidT,rachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. AnimalNumber:IR-3M kwi: Male Group: t 1) CONTROL 0 ppe Fate: (Week-106)TerminalSacrifice MacroscopicObservations: MicroscopicCbservations: Adrenal -No visiblelesions. -Corticalvacoolition@,UltifK&I,sild species:Rit PrDjKt Number:0261CROO12 Summarized STAR Page: 43 234 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObw vations RikerLaboratoriesI,nc. 3N FYr3924:Too Year UralToxicity-OncoginiciSttyudyin Rats Table:2 AnimalNumber:IR-3540 Six:Kale Group: 1 1) CONTROL0 ppe Fate:(Week=106)TerminalSacrifice MicroscopiOcbservation(scontinued): Kidney Liver Long LymphNode (sesenteric) Parathyroid Pituitary Thyroid -Chronicprogressivneephrepathys,ild -Portalsononucleacrellinfiltratem,ild Hepatocytveicuolationp,eripwtil,mild Hepatocytveacualitiolnimitedto oneareaof liver. -Vasculamrineralizatiosni,ld Alveolarmacrophages,minimal Perivisculsamronaclearinfiltratem,ild -Hemorrhage,mild -Notexaminedn,ot in plantof section -Cyst,parsdistalis -C cellcwcieosa The followintgissueswerefoundto be mithinnormallimits: Brain,SpinalCord,BaneMarron,Spleen,Heart,Stomach,Bull IntestineL,argeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,TrachealEsophagus,Pancreas, SalivaryGland,Eye. --- ----------- --------AnimalNumber:IR-3549 Sex: Nale Group: 1) CONTROL 0 ppe Fate:(Week-86)Sacrificeidn extresis MacroscopicObservations: Pituitary Liver MicroscopicObservations: Heart Liver Lung Parathyroid Pituitary Spleen Thyroid -Hemorrhagimcass, 1.4 x 0.8 ca. -Slightlpyale -Nyocarditisc,hronicnonsuppurativi, oultifocasli,ld -NepatKytevacuolationo,ultifecals,ild -Vascularmineralizatiomni,ld Alveolarmacrophages,minimal -Mt examined,missing -Adenosa -Onasiderosism,ild -Notexamined,missing Thefollowingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Doe Narrow,Kidney,Stomach,SmallIntestineL,argelstestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Adrenal,Trarbea,Esophagus, LymphNode toesenteric)P,ancreas,SalivaryBlind,Eye. Species:Rat Project Number: 0281CROO12 SummarizedSTAN Page: 44 235 SummarizSeidnglTeabulatAendimaRleport(continued) IndividuaMlacroscopiacndMicroscopiOcbservations RikerLaboratorieIsn,c. 3N FN-3924T:ooYearOralToxicity-OncoleniSttiutdyyin Rats Table:2 AnimalNumber:IR-3552 Six:Nile Group: 1) CONTROL0 ppe Fate:(Neeka106)TerminaSlacrifice MicroscopiOcbservations: Spleen MicroscopiOcbservations: Adrenal Kidney Liver Lung Pancreas Parathyroid Pituitary Prostate Spleen -Circularraisedlesion,1.2ce dia. -Corticavlacuolationo,ultilkal,mild Medullarcyellhyperplisial,ocalareas, moderate -Chronipcrogressivneephropathym,oderate -Portalsononklearcellinfiltratem,ild Portalbileductproliferatiosni,ld -Vasculamrineralizatiosni,ld Pneumoniai,nterstitiaclh,ronico,ultifocal, mild -kinaratrophym,ild -Notexaminedn,otin planeof section -Adenoma -Prostatitiasc,ute,suppurativem,ild -Hosangiosarcoma Thefollowintgissueswerefoundto be withinnormallimits: Brain,SpinalCord,loneNarrow,Heart,StomachS,mallIntestineL,argeIntestine, LWinaryBladderA,orta,Testis/EpididysTihsy,roid,TracheaE,sophagusL,ymphNodeItesenteric), SalivarByland,Eye. ---- -------------------- -- - ----- AnimaNlumberI:R-3553 Six:Nale Group: 1)CONTRO0Lppe Fate:(Week=88)FoundDead MacroscoOpbiscervations: Adrenal MicroscoOpbiscervations: Adrenal Eye Heart Kidney LargeIntestine Liver Lung LymphNode(sesenteric) -Leftenlargebdya Icedia.mass. -Sinusoideacltisiac,ortexs,ild Pheochrosocytboeun,ignu,nilateral -Notexaminemdi,ssing -Nyocarditcihsr,oninconsuppurative, oultifocamli,ld -Chronipcrogressnievpehropatwhiyl,d -Notexaminemdi,ssing -Portaslononiicclaelalrinfiltrawtiel,d Portablileductproliferatimoond,erate Repatocyvtaocuolatioounl,tifkimli,ld Necrosiosu,lti4ocmaill,d -Vasculmairneralizatmiiolnd, -Notexaminemdi,ssing SpeciesR:at ProjecNtumber0:281CROO12 SummarizSeTdARPage:45 236 SumArized SingleTabulatedAnimalReport tcontinved) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. SN M3924: Too Year OralToxicity-OncognicitSytudyin Rats Table:2 Animal Number: 12-3553 Sex:Nile Group: 1) CONTROL 0 ppo Fate: (Neeka OB) Found Dead MicroscopicObservationslcantinued): Pancreas Pituitary SalivaryBlind SmallIntestine -Not *%&mined,missing -Cyst,parsdistalis -Not examined,missing -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Stomach,UrinaryBladder,Art&, Prostate,Thyroid,Parithyroid,Trachea,Esophagus. ---------------- ---Animal Number: IR-3554 Sex: Kale Broup: 1) CONTROL 0 pps Fite: (Weekz106)TerminalSacrifice Testis/Epididysis, MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung Parathyraid Prostate -No visiblelesions. -Chronicprogressivenephropathy,moderate -Portalmanonucleacrellinfiltratea,ild Portalbileductproliferationm,ild Hapatocytaolterationv,icuolitedm,ild -Alveolarmacrophages,oultifocal,moderate Perivascul,aimronucltarinfiltrate,moderate Vascularsineralizatioani,ld Pneumoniai,nterstitialc,hronic,multifocal, moderate -Not examinedlnot in planeof section -Prostatitisa,ciites,uppurativem,oderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsi,tuitary,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBlind,Eye. AnimalNumber: IR-3555 Sex: Nale Group: 1) CONTROL 0 pps Fate: (Weeka102)Sacrificedin extresis MacroscopicObservations: Kidney UrinaryBladder MicroscopicObservations: Adrenal -Palo,enlikrgedsiildhydronephrosis. -Enlarged,fluidfilled,wallappears hemorrhagic. -Corticalvacuolitionl,ocalareas,moderate Species:Rat Project Number: 0281CROO12 Sonvited STAR Paqe: 46 237 SummarizedSingleTabulatedAftiulReport (continued) IndividualMacroscopicand HicroscapicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-OncoginiciSttyudyin Rats ------------- ---------- - --- - ------ AnimalNumber: IR-3555 Six:Kale Group: 1 1) CONTROL 0 ppe Fate:(Netkx102)Sacrificeidn extresis Table:2 MicroscopicObservations(continued): Aorta Heart Kidney Liver Lung Parithyroid Prostite SmallIntestine SPIM Stomach UrinaryBladder -Mineralizatiosni,ld -Nyocarditisc,hronicnonsuppurative, oultifocals,ild -Nephrosis,tubular,moderate Papillarynecrosis,moderate Hydronephrmis,mild Tubulesdilatedwith low,basophilic epitheliums,catteredmineralizedtubules. -Portalbileductproliferatiosni,ld NePatKytt VaCUOlitiOn@,UltifKal,mild -Yascularmineralizations,ild Alveolareacrophagess,ild Hemorrhage,fkal, mild -Not examined,not in planeof section -Prostatitisa,cute,suppuratives,ild Edema,intersititialm,oderate -Withinnormallimits Feverthan protocol number -Hemidemis,;oild -Edema, subsucosal,moderate -Hemorrhage, marked Epitheliahlyperplasias,imple,diffuselmild Cystitis,acute,moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,LargeIntestine,Ttstis/EpididysiPsi,tuitary,Thyroid, Trachei,Esophigus,LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. ------------------------- Animal Number: IR-3556 Sex: Nale Group: 1 1) CONTROL 0 ppe Fite: (Neekz106)TerminalSacrifice MacroscopicObservations: Adrenal MicroscopicObservations: Adrenal Kidney Liver -Rightonlirgtdby @ass,2 x I ce. -Carcinomac,ortieil,unilateral Large neoplasm,mostlynecrotic. Cells foamy,polyhedralirrangedin cordsand sheets.Highmitoticactivity.Multiple lung metastases. -Chronicprogressivenophropathy,mild -Portalsononucleacrellinfiltratimgild Portalbileductproliferatimm,ild Species:Rat Project Number: 0291CROO12 SummarizedSTU Page: 47 238 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncogenicitSytudy in Rats AnimalNumber:IR-M Six: Kale Fate: (Weekz106)TerminalSacrifice - ------------Group:1 1) MMOL 0 ppa Table:2 MicroscopicObservations(continued): Lung Parathyroid -Pneumoniai,nterstitialc,hronic,oultifocal, mild Metastaticneoplasm Perivasculisiornonucleairnfiltratem,ild Yascularmineralizations,ild -Notexamined,not in plantof section The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,DoneNarrow,Spleen,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Thyroid,Trachea,Esophagus, LymphMade (sesenteric)P,ancreas,SalivaryGland,Eye. --------------------- Animal Number: IR-3557 Sex:Halt Group: 1) CDKTROL 0 pps Fite: (Neeks106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung Thyroid -No visiblelesions. -Chronicprogressivenephropithys,ild -Portalsommuclearcellinfiltratem,ild NtoitKyttalterationv,acuolatedm,ild -Viksculimirneralizations,ild Pneumoniai,nterstitialc,hronic,oultilocal, mild -HyperpliisiCic,ell,mild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone lkrrou,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/Epididy2iPsr,ostate,Pituitary,Adrenal,ParathyroidT,rachea, Esophagus,Lymph Mode (sesentoric)P,ancreas,SalivaryGland,Eye. -------------------- - --- - - - - --- ---------------- AnimalNumber:IR-MO Sex: Nale Group: 1 1) CONTROL 0 ppe Fite: (Beeka106)TerminalSacrifice MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Liver -Raisedmass,0.9 ce dia. -Sinusaidaelctasia,cortex,mild -Chronicprogressivenephropathy,mild Calculus,pelvic,minimal -Cystoiddegenerationf,ocal,sinisal Species:Rat Project Number: OnICROO12 Sumw ized STAR Page: 48 239 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaborstoringInc. 3H Fli-3924T:oo Year Oral7o%icity-OncogenicitSytudyin Rats Table:2 AnisalNumber: IR-3558 Sax: Kale Group: ( 1) CONTROL0 ppe Fate: (Week=106) TerminalSacrifice MicroscopicObservations(continued): Parithyroid Pituitary Spleen -Not examined,not io planeof section -Adenoma -Hooosiderosiss,ild The followingtissues*erefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Heart,Lung,Stomach,SmallIntestine,LargeIntestine, UriniryBladder,Aorta,Testis/EpididysiPsr,ostate,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. --- ------------------- --------- Animal Number: IR-3560 Sex: Kale Group: 1) CONTROL 0 ppe Fate:(Weekz35) Sacrificedin extresis MicroscopicObservations: Brain Lung Spleen Lymph Made (abdominal) Liver ' MicroscopicObservations: Brain Liver Lung LymphNode (sesenteric) SmallIntestine Spleen 4ocal circumscribeddark area,dorsal surface,leftcerebralhemisphere (0.2ce dia.)andlateralsurfaceof right cerebralhemisphere(0.2ce dia.) -Darkreddiffusemottlingpall lobes;red frothyexudateat trachea. -Enlarged -Hepaticand rnal nodesenlarged. -Pale,appearsenlarged. -Abscess,mild Hemorrhage,oultifocal,moderate -Malignantlymphosith,istiocytic -Malignantlymphoma,histiocytic Nmrrhige, diffuse,marked Necrosis,localareas,marked -Hemorrhage,minimal -Withinnormallimits Fewer than protocolnumber -Hetatopciesise,xtramedullaryi,ncreased, marked The followingtissues*ere foundto be withinnormallimits: SpinalCord,BoneKarroo,Kidney,Heart,Stomach,LargeIntestine,UrinaryBladder,Aorta, Ttstis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,ParathyroidT,rachea,Esophagus, Pancreas,SalivaryBland,Eye. ------------------ ------ Species:Rat Project Number: ONICROO12 SummarizedSTU Page: 49 240 SummarizedSingleTabulatedAnimalReport (continued) IndividualNicroscopicand NicroscDpicObservations RikerLaboratoriesI,nc. 3H Ffl-3924T:oo Year OralToxicity-OncogeniciSttyudyin Rats - --- --- --- -- - Animal Number: IR-3561 Sex: Nale Broup: 1) CONTROL 0 pps Fate: (Weekz106)TerminalSacrifice Table:2 RacroscepicObservations: SoftTissues(leg) Kidney NicroscopicObservations: Adrenal Done Done Narrow Kidney Large Intestine Liver Lung Parathyraid Pituitary Spinal Card Spleen Testis/Epididymis Thyroid -Rightand lefthindpawand right forepaw swollen. -Rightkidneypolycystic. -Cortical VACVOI&ti0ft, UltifK&I, sild Nedulliry cell hyperplasia,@UltifK&I, mild -Arthritiss,ynovitisj;oints,hindleg, foreleg,marked -Not examined,missing -Chronicprogressivenephropathy,mild Pelvicmineralizationm,ild Cyst,cortical,unilateralm,arked -Nesitodiasisc,olon -Portalsononacleacrellinfiltrates,ild Portalbileductproliferatiosni,ld -Perivasculasronanucleairnfiltrates,ild Vascularmineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, aild Hemorrhage,local areas, moderate -Not examined,missing -Adenomi -Not examined,missing -Hesosiderosiss,ild -Tubuleatrophy,aspereatogenesism,oderate Polyarteritism,arked -Not examined,missing The followingtissues*erefoundto be withinnormallimits: Brain,Heart,Stomach,Seill IntestineU,rinaryBladder,Aorta,Prostate,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. --- ----------------------------------------- ------ --------------------------- --- -- AnimalNumber: IR-3U2 Sex: Hale Group: 1) CONTROL 0 ppe Fate: (Week=106)TerminalSacrifice NacroscapicObservations: Skin SPIm HicroscapicObservations: Adrenal ----------------- -Raisedulceratedinflassedlesion,rightrear footpid. -Severalpale foci. -Nodularhyperplasiac,ortex,uniliteralp moderate Species:Rat Project Number: 0261CROO12 Summarized STAR Page: 50 241 Sumarized SingleTabulatedAnimalReport(continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924: Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 Animal Number: IR-3U2 Sex: Kale Broup: Fate: (Neeks106) TerminalSacrifice 1) CONTROL 0 ppe MicroscopicObservations(continued): Heart Kidney Large Intestine Liver Lung Pirathyroid Pituitary Salivary Bland Skin -NYKarditis, chronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropathy,sild -Netatodiasis,colon -Portalannonscleacrill infiltrates,ild -Vascularmineralizations,ild Pneumonia,interstitialc,hronic,sild Perivisculasrononuclearinfiltrate,aild -Not examined,not in plane of section -Adenoma -Not examined,missing -Pododersatitisu,lcerative,hindleg,aarked The followingtissueswere found to be withinnormal limits: Brain, Spinal Cord,Bone Narrow,Spleen,Stomach,Small Intestine,Urinary Bladder,Aorta, Testis/Epididymis,Prostate,Thyroid,Trachea,Esophagus,LymphNode (sesenttric),Pancreas,Eye. - --- ----- -- ---- - Animal Number: IR-3563 Sex:ble 6roup: 1 1) CONTROL 0 pps Fate: (Neekz106) TerminalSacrifice MacroscopicObservations: Thyroid Skin MicroscopicObservations: Adrenal Brain Heart Kidney Liver Lung Pancreas Pituitary Prostate -*e side enlarged,I s 0.9 ce. -Mass, 1.7 1 1.4 ce, dorsalarea. -Corticalvacuolations,ultifocal,mild Sinusoidalectasia,cortex,minimal -Astrocytosa,benign Poorlydefinedlesionin basal area of cerebrum. Tumorcells spindelate. -MyKarditis, chronicnontuppurative, @UltifKAI, mild -Chronic progressivenephropathy,moderate -Hepatocytealteration,basophilic,moderate Portalsononucleircell infiltratem,ild Hepatocytealteration,vacuolited,moderate Necrosis,localareas, moderate -Vascularmineralizationm,ild Perivascularsonanuclearinfiltrate,mild -kiner atrophy,marked -Adenna -hostatitis,acute,suppurative,moderate Species:Rat Project Number; 0261CROO12 Summarized STAR Page: 51 242 SummarizSeidnglTeabulateAdnimaRleport(continued) IndividuMailcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3N FN-3q24T:woYearOralToxicity-OncogenRiucdiytiynRats Table2: Animal Number: IR-3563 Sn: Kale Group: ( 1) CONTROL0 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations(continued): Skin Thyroid -Keritoacanthomab,ack -C cell carcinoma The followingtissueswerefoundto be withinnormallimits: SpinalCord,-DoneNarrow,Spleen,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder, Aorti,Testis/EpididysisP,arathyraid,Trachea,Esophagus,LymphNode (aesenteric), SalivaryGland,Eye. Animal Number: IR-3564 Sex: Nale Group: 1) CONTROL 0 ppe Fite:(kwka 106)TerminalSacrifice MacroscopicObservations: Kidney MicroscopicObservations: Adrenal Done Narrow Heart Kidney Liver Lung Pancreas Parathyroid Pituitary SalivaryGland Spinal Cord Testis/Epididysis -Pileareain cortexof one kidney. -CorticalVACUOI&tiOnB,UItifKal,aild Medullarcyellhyperplisiis,ultifocil, moderate -Not examined,missing -Nyocarditisc,hronicnonsuppurative, oultifocalm,ild NyKardiiiflibrosisR,UltifKal,sild -Chronicprogressivenephropathy,moderate Cyst,unilateralm,oderate Areaof oultiloculacrystsin cortexwith lipid changein surroundingparenchyma. -Portalbileductproliferatiosni,ld Hepatocytveicualationo,ultifocals,ild Portalsonanucleacrellinfiltratem,ild -Vascularmineralizations,ild -Not examined,missing -Not examined,not in plantof section -Adenosa -Not examined,missing -Not examined,missing -Nineralizationf,ocal,mild The followingtissueswere foundto be withinnormallimits: Brain,Spleen,Stomach,Small IntestineL,arge Intestine,UrinaryBladder,Aorta,Prostate, Thyroid,Trachea,Esophagus,LymphNode (sesenteric)E,ye. Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 52 243 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N Ffl-3q24T:itoYear OralToxicity-OncogeniciSttyudyin Rats ---- ----------Animal Number: IR-3565 Sex: Hale Fate:(Week- 04) FoundDead 6roup: 1) CONTROL 0 ppe Table:2 MicroscopicObservations: Skin Liver MicroscopicObservations: Adrenal Aorta Esophagus Eye Kidney LargeIntestine Liver Lung Lymph Node (sesenteric) Pancreas Pirithyroid Pituitary Prostate SalivaryGland Skin SmallIntestine Spleen Thyroid Trachea UriniryBladder -Large&ass,7 x 7 ce, scrotalarea. -Pale -Not examined,missing -Not examined,missing -Not examined,missing -No diagnosis,inadequatesection -Chronicprogressivenophropithys,ild -No diagnosis,inadequatesection -ftpatocytveicuolationo,ultifdcalm,ild Necrosis,ultifocal,moderate -Vascularsineralizatioem,ild -Not examined, missing -Not examined, missing -Not examined, missing -Not examined, missing -Not examined, missing -Not examined, missing -Liposarcm The scrotalmass was composedof Iarge, vicuolatedsmanuclearcells. The degreeof autolysismade diagnosissomewhatuncertain. -Not examined,missing -Resatopoiesise,xtrasedullaryi,ncreased, sild -Not examined,missing -lot examined,missing -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,Testis/Epididysis. ---- ---- - --- -----------------Animal Number: IR-3566 Sez: Nale Broup: 1) CONTROL 0 pps Fate: tneekz106)TerminalSacrifice MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney -Smalldark lesion. -Vithinnormallimits One of pair present -Chronicprogressivenophropithyt,ild Species:Rat Project Number: 0281CROO12 Stmarized STAR Page: 244 SummarizedSingleTabulatedAnimalReport (continued) liidividuaMlacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N W3924'. Two YearOral 7oxicity-OncogeniciSttyudyin Rats ----------AnisalNumber:IR-3566 Sitx:Nale Group: Fate:(ktkx 106)TerminaSlacrifice 1) CONTRM 0 ppe Table:2 MicroscopiOcbservationlscmtinued): Liver Lung Pancreas - Parathyraid Spleen -Portalmanonucleacrellinfiltratem,ild Portalbileductproliferatiomni,ld -Yasculamrineralizatiosni,ld Perivascularmonuclearinfiltratem,ild -Polyarteritimso,derate -Notexaminedn,ot in plantof section -Hm siderosiss,ild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Boe Narrow,LargeIntestineU,rinaryBladder,Aorta,Testis/Epididyais, Prostate,Pituitary,Thyroid,Trachea,LymphNode (sesenteric)S,alivaryGland,Stomach, SmallIntestineH,eart,Eye,Esophagus. ---------- ----------------------- - - --- --------- --- - - ---------------- AnimalNumber:IR-'j567 Sex: Male Broup: 1) CONTROL 0 pps Fate:(Weekz106)TerminalSacrifice MacroscopicObservations: Skin Spleen MicroscopicObservations: Adrenal Kidney Liver Lung Skin Spleen -Raisedpipillamatypemassan back;raised , inflaosedlesion,rightrearfootpad. -Twopalefoci. -Corticavlacuolatioonu,ltifocals,ild Nodularhyperplasiac,ortex,focal&m,ild -Chronicprogressivenephropathy,moderate -Portalsonanucleacrellinfiltrates,ild -Yasculamrineralizatiomni,ld Alveolarmacrophages,minimal Perivasculasronanucleairnfiltratem,inimal -Pipillosab,ack Pododeriatitiusl,cerativeh,indleg,marked -Necrosisl,ocalareas,moderate The followintgissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneKarroo,Heart,Stomach,SmallIntestineL,argeIntestine, UrinaryBladder,Aorta,Testis/EpididymiPsr,ostateP,ituitaryT,hyroid,ParathyraidT,rachea, Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ---------------------------------------------------------------------------- Species:Rat Project Number:0281CROO12 Sumerized STAR Page: 5it 245 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3124:Tvo Year OralToxicity-OncogeniciSttyudyin Rats -------- ------------ --- --- -Animil Number:IR-3569 Six: Hale Fate: (Week-106)TerminalSacrifice group: 1) CONTROL 0 ppe Table:2 MicroscopicObservations: Kidney MicroscopicObservations: Adrenal Heart Kidney Liver Lung Pituitary Testis/Epididysis -Bilateralleynlargedp;ale,pitted. -Corticalvacuolationf,ocal,minimal Sinusoidaelctasia,cortex,sild Medullarycell hyperplasiao,ultifocalm,ild -Nyocarditisc,hronicnmsuppuritive, oultifkalo,ild -Chronicprogressivenephropathy,@irked -Portalmanoftuclecaerllinfiltrates,ild Nepatocytevacualationo,ultifocalm,ild -Vasculamrinerilizitiosni,ld Perivasr.slsamranuclearinfiltratem,ild -Hyperplisiaf,ocal,parsdistalis,mild -Polyirteritimso,derate The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,DoneNarrow,Spleen,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorti,Prostate,Thyroid,ParithyroidT,rachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ------------------------------------ --- - - - ---------------- Animal Number: IR-3571 Six: Kale Group'. 1) CONTROL 0 ppe Fite: (Week=106)TerminalSacrifice MicroscopicObservations: Liver Kidney Resentery MicroscopicObservations: Adrenal Heart Kidney Liver Lung Resentery Pancreas -Parathyraid Pituitary - -- --- --- - -Pale -Pale,pitted,enlarged. -Resentericvesselsthickened -Corticalvacuolationf,ocal,minimal -NYKirditis,chronicnonsuppurative, oultifocalm,inimal -Chronicprogressivenephropithy,marked -Portilsononscleacrellinfiltratem,ild Portalbileductproliferatiosni,ld Nepitocytveacuolitidno,ultifocils,ild -Vascularsineralizationm,ild Perivasculasrononuclearinfiltratem,inimal -Polyarteritism,arked -Polyarteritism,arked -Notexamined,not in planeof section -Not examined,missing --- ------ -- ------------ Species:Rat Project Number: 0281CROO12 Sumarized STU Page: 55 246 Sunarized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3571 Sex: Bale Broup: ( 1) CONTROL0 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations(continued): SmallIntestine Spleen Testis/Epididysis -Polyarteritiss,esentery,marked -fletasiderosimsi,ld -Polyarteritism,arked The following-tissuweesre foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Stomach,Large Intestine,UrinaryBladder,Aorta,Prostate, Thyroid,Trachea,Esophagus,LymphNode (sisenteric)S,alivaryBlind,Eye. ------------------------------ Animal Number: IR-3572 Sex: Nale Broup: 1 1) CDKTROL 0 ppe Fate: (Weekz106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung Pancreas Parathyraid Stomach -No visiblelesions. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,ild Portilbileductproliferatiomni,ld Repatocytvoacuolationo,ultifocals,ild -YaKular sineralizatiosni,ld -Hyperplasiai,sletcell,moderate -Mt examined,not in plantof section -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,DoneNarrow,Spleen,Heart,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Trachea, Esophagus,LymphNode (sesenteric)S,alivaryBland,Eye. ---------------------------- - AnimalNumber: IR-3573 Sex:Halt 6roup: 1) CCKTROL 0 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations: Pancreas MicroscopicObservations: Adrenal Kidney LargeIntestine Liver -Smallcircularpale mass,0.5 ce dia. -Corticavlacuolationo,ultifocalm,ild PheochrOGKYtO@&,benign,unilateral -Chronicprogressivenephropathy,mild -keatodiasisc,olon -Kepatacytaelteration,vacuolated,mild M*atocytealterationb,asophilicm,ild Portalbileductproliferatims,ild Hepatocytveacoolationo,ultifkallsild Portalsononucleacrellinfiltrates,ild Species:Rat Project Number: ONICROO12 Sumrized STAR Page: M 247 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3124:Two Year Oral Toxicity-OncogenicitSytudy in Rats Anisal Number:IR-3M Six: Nale Fate: (Neeks106) TerminalSacrifice Group: 1 1) CONTROL 0 ppe Table: 2 microscopicObservationslcontinued): Lung Pancreas Parathyraid -Vascularmineralizationm,ild Perivascularsononuclearinfiltrate,mild -Acinaratrophy, moderate Isletcell adenosa -Not examined,not in plant of section The followingtissueswere foundto be withinnormallimits: Brain, Spinal Cord, Bone Marro*,Spleen,Heart, Stomach,Small Intestine,UrinaryBladder, Aorta, Testis/EpididysisP,rostate,Pituitary,Thyroid,Trachea,Esophagus, Lymph Node Isesenteric),SalivarySland, Eye. Animal Number: IR-3574 Sex: hale Group: Fate: (Weekz 99) Sacrificedin estrnis 1) CONTROL 0 pps Microscopic Observations: Skin Thorax(internal) Heart Livw Kidney Testis/Epididysis MicroscopicObservations: Adrenal Avti Heart Kidney Liver Lung Lymph Node (onenteric) Pancreas Parathyroid -Ulceratedright and left hind footpads; circular white subcutaneousmass, 1.5 ce dia.,in rightinguinalarea. 4illed withfluid. -Slightlypaleand flaccid. -Slightlypale -Paleand pitted;1.5 ce cystin right kidney. -Testissmall -Corticalvacuolationo,ultifocal,mild -Necrosis,local areas, moderate Uniformintiul necrosiswith reactive cellularinfiltrate. -NyK&rditis,chronicnonsuppurative, oultifkal,mild -Chronic progressivenophropithy,marked Cyst, unilateral,marked -Portalmanonucloarcell infiltrates,ild Portalbile ductproliferationm,ild -Pneumonia,interstitialc,hronic,diffuse, moderate Perivisculasronanuclearinfiltrates,ild Edema, local areas, marked -Not examined, missing -Acinaratrophy,sild -Not examined,not in plant of section - ---- --------- Species: Rat Project Number: 0261CROD12 Smearized STAR Page: 57 248 Suuarized SingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObwvations RikerLaboratoriesI,nc. 3N FN-3924;Two Year Oral Toxicity-ftcogeniciSttyudy in Rats Table:2 Animal Number: IR-3574 Sex: Nale Group: 1) CONTROL 0 ppe Fate:(Neekm ") Sacrificeidn extromis NicroscopicObservationslcantinued): Pituitary Prostate SalivaryGland Skin Testis/Epididysis -Cyst,pars intersedia -Prostatitisa,cute,suppurativem,oderate -Not examined,missing -Fibroma,subcutaneous,inguinal Podadereatitisu,lcerativeh,indleg,marked -Tubuleatrophy,aspereatogenesisb,ilateral, moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCvd, DoneNarrow,Spleen,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Thyroid,Trachea,Esophagus,Eye. --------------------- ------------ - --- -- -- Anisal Number:IR-3576 Be%: Nale Group: 1)COM Fate:(Neekz55)Sacrificeidn extrmis 0 pps MacroscopicObservations: Skin Abdomen(internal) MicroscopicObservations: Kidney Long Parathyraid SPIM UrinaryBladder -Raistareaaroundgenitalpapilla. -Largeamountof gas in gastrointestinal ,tractino food in stomach. -Pelvicsineralizationm,ild -Hew rhage, diffuse, marked -Not examined,not in planeof section -Nmosidtrosisi,iild -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Harrov,Liver,Heart,Stomach,SmallIntestine,Large Intestine,Aorta, Testis/EpididyeisP,rostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. - -- -- - - - --- --- - AnimalNumber:IR-3M Sex: Kale Group: 1) CONTROL 0 ppe Fate:(kekz 106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver -No visiblelesions. -Chronicprogressivenophropithy,moderate -Portalsononucleacrellinfiltratem,ild Portalbileductproliferatiosni,ld 4PItOCYttV8CVOlitiORUtltifK&ll mild CystoiddegenerationB,UItifK&I, mild Nepitacytaelterationv,acuolitedm,ild Species:Rat ProjectNumber: OnICROO12 SuamikrizedSTAN Page: 59 249 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-WcogenicitSytudyin Rats -----------AnimalNumber: IR-3577 Sex: Kale Group: Fate:(Neeka106)TeriiiniSlacrifice 1) CONTROL 0 pps Table:2 MicroscopiOcbservationtscantinued): Lung Resentery Pancreas SmallIntestine Spleen Thyroid -Vasculasrintralizatiosnisld -Polyarteritimsa,rked -Polyarteritimsa,rked -Polyarteritisst,sentorym,oderate -Hmsiderosis,mild -Cyst,colloid,mild Thefollowintgissueswerefoundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Heart,Stomach,LargeIntestineU,rinaryBladder,Aorta, Testis/EpididysiPsr,ostate,PituitaryA,drenal,ParathyroidT,rachea,Esophagus, LymphNode (sesenteric)S,alivaryGland,Eye. Animal Number: JR-3578 Sex:Kale Group: 11 CONTROL 0 pps Fate:ineekz106)TerminalSacrifice MicroscopicObservations: Pituitary Skin MicroscopicObservations: Kidney Liver Lung Pituitary Prostate SalivaryGland Skin -Hemorrhagimcass,0.7 ce dia. -Raisedulceratedinflamed lesion,1.5ce dia.,leftkindfootpad. -Chronicprogressivneophropathym,ild Hydronephrosisu,nilateralm,oderate Calculipresentin ureterof hydronephrotic kidney. -Portalsononueleacrellinfiltratem,ild Portalbileductproliferatiosni,ld -Vasculasrineralizatims,ild Hemorrhagel,ocal areas,moderate -Menoma -Prostatitis&,cut@,suppurativem,oderate -Sialadeniticsh,ronic,minimal Veryminimallesion,onlyone ductaffected. -Pododereatitiusl,cerativeh,indleg,marked Thefollowintgissues*erefoundto be withinnormallimits: Brain,SpinalCord,Done Narrco,Spleen,Heart,Stomach,Small IntestineL,arge Intestine$ UrinaryBladder,Aarti,Testis/EpididysiAsd,renal,Thyroid,ParathyroidT,rachea,Esophagus, LymphNode fmesenteric)P,ancreas,Eye. Species:Rit ProjectNumber:ONICM12 %amarized STAR Page:59- 250 SummarizedSingleTabulatedAnimalReport (continued).IndividualNacroscopicand NicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too Year Oral Toxicity-beogenicitSytudyin Rats -- --- --- ----------- - -- Animal Number: IR-3579 St-x:Nile Broq: Fate:(Weeka86)Sacrificeidn extruis -- -- - - 1) CONTROL 0 pps Table:2 NacroscopicObservations: Pituitary Liver Skin KicroscopicObservations: Kidney Liver Lung Parathyraid Pituitary Skin SmallIntestine Spleen Testis/Epididysis -Raisedmass,0.6 ca dia. -Raisedpale2 cc dia.massin rightlateral lobe. -Massseenclinicallyon rightside appearsto be healedlesion. -Chronicprogressivenephropithy,marked -Portalbileductproliferatiomni,ld Repatocellularcarcinoma Portalsonanucleacrellinfiltrates,ild -Perivasculasronanucleairnfiltratem,ild -Notexamined,not in planeof section -4Wencoa -Keratuicanthoma Skin lesionfromrightside. -Withinnormallimits Fever than protocolnumber -Hmsiderosis,sild '-Tukleatrophy,aspereatogenesisu,nilateral, sild Polyarteritissi,ld The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Heart,Stomach,Large Intestine,LirinarByladder,Aorta, Prostate,Adrenal,Thyroid,Trachea,Esophagus,LymphNode (sesenteric)P,ancreas, SalivaryBland,Eye. ------------------------- --- --- ------------------------- --------------------------- Anisal Number:IR-4576 Sex: Female Broup: 1) CONTROL 0 ppe Fate:(Weeka 25) Sacrificeidn extresis NacroscopicObservations: Liver Lymph Node lbronchial) Lung Spleen Stomach Lymph Node (sesenteric) NicroscopicObservations: Adrenal Done Narrow Kidney -Enlarged;mottledyellowcolor. -Enlarged -Pale -Enlarged -Red patchyareas on sucosa. -Enlargedand reddened. -Sinusoidaelctasit,cortex,mild -Nalignantlymphona,lymphocytic -Nalignantlymphosa,lyaphocytic Hineralizatiocno,rticals,ild species:Rat Project Number: 0281CROO12 Summarized STAR Page: ;o 2 5 1 SummarizedSingleTabulatedbisal Report(continued) lndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too Year oral Toxicity-OncogeniciSttyudyin Rats ------ - - -------Animal Number: IR-4576 S4ix: Female Group: Fate:(Weeks 25)Sacrificedin extresis 1) CONTROL 0 ppe Table:2 MicroscopicObservations(continued): Liver Lung Lymph Node (sesenteric) Pancreas Salivary Gland Spinal Card Spleen Stomach Urinary Bladder -Malignantlyaphosa,lympbacytic -Malignantlyaphosallymphocytic Hemorrhage,oultifocal,mild -Malignantlyaphoma,lyophkytic -Malignantlyaphosa,lyaphocytic -Not examined, missing -Malignantlyaphoma,lymphocytic -malignantlyaphoma,lyaphocytic -Ulcer -Epithelialhyperplasia,simple,diffuse,mild The followingtissueswere found to be withinnormallimits: Brain,Heart,Small Intestine,Large Intestine,Aorta,Uterus,Ovary,MammaryGland,Pituitary, Trachea, Thyroid, Parathyroid,Esophagus,Eye. ------------------- ----Animal Number: IR-4577 Six: Female Group: 1) CONTROL 0 pps Fate: (Meek= 99) Found Dead MacroscopicObservations: Pituitary@ Mammary Slind MicroscopicObservations: Adrenal Kidney Liver Lymph Node (sesenteric) Himeary Gland Pituitary Spleen Uterus -kwrrhagic mass,0.0 ce dia. -Rultilobulamrass,4.5 1 3.5 1 2 ce, in right alilla. -Sinusoidalectasia,cortex,moderate -Pelvicmineralizationm,ild Nephrosis,tubular,marked -Portalsononuclearcell infiltratem,ild Portalbiltduct proliferationm,ild *atocyte vicuolationo,ultifocalm,ild -Not examined,missing -Labularhyporplasia -Nmrrhage, marked Necrosis, moderate -Hmsideresis, mild -Cystic glands,moderate The followingtissueswere found to be withinnormal limits: Brain, Spinal Card,Bone Narrow,Heart, Lung, Stomach,Small Intestine,Large Intestine, Urinary Bladder,Aorta, Ovary, Trachea, Thyroid,Pirathyroid,Esophagus,Pancreik%o SalivaryGland, Eye. Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 61 252 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FA-3924:Two Year OralToxicity-OncogenicitSytudyin Rats Table:2 Animal Nuaber: IR-4579 Sex:Female Group:1 1) COMM 0 ppe Fate:(Week--84)Sacrificeidn extrnis MicroscopicObservations*. Pituitary Skin Liver stomach Kidney MicroscopicOb!iervations: Adrenal Aorta Heart Kidney Liver Lung Lymph Node (sesenteric) Parathyroid Pituitary Skin Spleen Stomach -Raisedmass,0.5 ce dia. -Raisedthickenedlesionwith scab on right side. -Slightlypale -Somewhat reddened -Fluidfilledcystin leftkidney. -Sinusoidaelctasii,cortex,aild -Mineralizatioonu,ltifocals,ild -Nyocarditisc,hronicnonsuppurative, oultifocal,moderate -Kephrosis,tubular Pelvicmineralizationm,arked Cyst,cortical,moderate Hyperplasiap,elvicepitheliumd,iffuse,mild -Hepatocytveacuclations,ultifocalm,ild -Vascularmineralizations,ild -Not examined,missing -Notexamined,not in planeof section -4wonoma -Ulcer,marked Skin lesionfrom side. -Wasiderosis,iiild -Mineralizatiosnu,cosal,sild The followingtissueswere foundto be mithinnormallimits: Brain,SpinalCord,Done Narrow,SmallIntestine,LargeIntestine,UrinaryBladder,Uterus, Ovary, MammaryGland, Trachea,Thyroid,Esophagus,Pancreas,Salivary61ind, Eye. - ------------ ------- - ---------- AnivilNumber:IR-4590 Sex: Female Group: 1) CONTROL 0 pps Fite:(Week= 52) Sacrificeidn extromis MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Aorta Esophagus LymphNode (sesenteric) Mammary Gland Parathyroid ------------- - ---------- -Enlarged!dark red mass,0.5 co dia. -Sinuscidaelctasia,cortex,sild -Not examined,missing -Not examined,missing -Not examined,missing -Salactocell -Mt examined,not in PlantOf Section Species:Rat Project Number:OnICROO12 kimwized STAR Page:fir 253 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-UncogeniciSttyudyin Rats Table:2 AnimalNumber: IR-4580 Sex:FiaiileBroup: ( 1) CONTROL0 ppe Fate:tkttkz 52)Sacrificeidn extremis MicroscopicObservations(continued): Pituitary Spleen -Adtnomi -Hm siderosis,moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Liver,Kidney,Heart,Lung,Stomach,Small Intestine, Large IntestineU,rinaryBladder,Uterus,Ovary,Trachea,Thyroid,Pancreas,SalivaryBlind,Eye. -------------------------------- -- Animal Number: IR-4581 Sex: Female Group: 1) CONTROL 0 ppe Fite:(Week=85) Sacrificeidn extresis MacroscopicObservations: Mammary gland Liver Spleen MicroscopicObservations: Adrenal Liver Lung HassiryBlind Pirathyraid Spleen -Ulceratedmass,6 1 6 1 3 ce behindright shoulder. -Possiblyslightlypale and swollen. -Enlarged -Sinusoidalectasia,cortex -Poftalsononucleacrellinfiltratem,ild Hapatocytevicuolationg'sulti4ocmaill,d Hepatocytealteration,basophilic,mild Resatopoiesisi,ttratedullarsyi,ld -Vascularsineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, mild -Adenocarcincei -kt examined,not in planeof section -Betatopoiesise,xtramedullaryi,ncreased, marked The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Kidney,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Pituitary,Trachea,Thyroid,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. --- --- ---------- --------- ----- - ------ ---------------- Animal Number: IR-4583 Sex: Female Broup: 1) CONTROL 0 ppe Fate: (Week-105)TerminalSacrifice MacroscopicObservations: Eye Ramary Bland -- -------- -Extensivepostbleedinginilawationof right eye. -Firenodularmass,6 1 5 1 3 cal left inguinal. Species:Rat Project Number: 0281CROO12 Sua&rized STAR Page:6r, 254 SummarizedSingleTabulatedAnimalReport icontinved) IndividualNacroscopicad NicroseopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year OralToxicity-OncogeniciSttyudy in Rats Table: 2 Animal Number: IR-4583 Six: Female Group: 1) CONTROL 0 ppe Fite: (Veekx105)TerminalSacrifice NicroscopicObservations(continued): Adrenal Eye Kidney Liver Lung HassiryGland Ovary Parathyroid Spleen Uterus -Sinusaidalectisia,cortex,marked -Panaphthalsitiusn,ilateral,marked -Pelvicmineralizationm,ild Chronicprogressivenephrdpathy,minimal -*atocyte vacuclationa,ultifocalm,ild Necrosis,focal,mild -Alveolareacrophages,mild Perivasculasrononucleairnfiltratem,ild -Fibroadenosi -Tubularadenoma,unilateral -Notexamined,not in planeof section -Nuatopciesis,extrasedullaryi,ncreased, moderate -Cysticglands,marked The followingtissuesNere foundto be withinnormallimits: Brain,SpinilCord,Bone Narro*,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Pituitary,Trachea,Thyroid,Esophagus,LymphMode (sesenteric), Pincreis,SalivaryGland. ---------- ----------Animal Number: IR-4504 Sex: Female Group: 1) CONTROL 0 pps Fite: (Weekz105) TerminalSacrifice RicroscopicObservations: Eye Pituitary Adrenal NicroscapicObservations: Adrenal Eye Heart Kidney Liver Long Parathyroid -Slightatrophywith cornealopacity,right eye. -Enlarged -Leftadrenalenlarged. -Sinusoidalectasia,cortex -Phthsisbulbi,moderate -Nyocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropithy,mild -Portalbileductproliferatiomni,ld Repatacytevacuolationo,ultifocals,ild -Pneumoniai,nterstitialc,hronic,oultifacil, mild Periv&Kularmonuclitarinfiltratem,ild Hemorrhage,localareas,sild -*ot examined,not in planeof section Species:Rit Project Number: 0281CROO12 Sm arizedSTAR Page: 64 Sumarized SingleTabulatedAnimalReport(continued) IndividualMicroscopicand NicroscopicObservations RikerLaboratoriesI,nc. 3N Ffl-3924T:oo YearOral Toxicity-WcogenicitSytudyin Rats - -- --- --- -AnimalNumber: IR-4504 Six: Female Group:( 1) CONTROL0 ppe Fate:(Week=105)TerminalSacrifice Table:2 NicroscapiOcbservation(scontinued): Pituitary Spleen -Adenoma -Hemosidernsism,ild The followintgissueswerefoundto be withinnormallimits: Brain,Spinal-CordB,oneNarrow,Stomach,SmallIntestineL,argeIntestineU,rinaryBladder, Aorta,Uterus,Ovary,Hassary61and,Trachea,Thyroid,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryBlind. --- --- ---------------------- AnimalNumber:IR-4586 Sex: Female Group:1 1) CONTROL0 pps Fate:(Weekt105)TerminalSacrifice MacroscopicObservations: Pituitary Uterus Microscopic Observations: Adrenal Kidney Liver Lung Ovary Pancreas Parathyraid Pituitary Uterus -Raiseddarkmass,0.3 ce dis. -Darkarea,0.5 x 0.5 ce,in leftborenear cervix. -Sinusoidaelctasia,cortex,mild -Chronicprogressivneephropathys,ild Pelvic liwalizatim, sild -Portalsononucleacrellinfiltratem,ild Portalbileductproliferatiomni,ld Mpitocytoalterationv,acuolatedm,ild -Perivisculasronenucleairnfiltratem,inimal -Notexamined,missing -kinar atrophy,moderate -Notexamined,not in plantof section -Adenama -Cysticglands,marked Thefollowintgissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,SmallIntestineL,argeIntestine, UrinaryBladder,Aorta,Mammary61ind,Trachea,Thyroid,Esophagus,LymphNode (sesenteric), Salivary61and,Eye. AnimalNumber: IR-4567 Sex:Female Group: 1) CONTROL 0 ppe Fite:(Neekz105)TerminalSacrifice Macroscopic Observations: Mammary 61&nd -Smallnodular&ass,3 1 2 to, axillaryl;arge mass,9 1 8 1 3 ce, throatarea. Species:Rat ProjectNumber:0281CH012 Swmarized STAR Page:65*- 256 SummarizSeidnglTeabulatAendimaRleport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too Year Oral Toxicity-OncogeniciSttyudyin Rats -------------------- AnimalNumber: IR-4587 Six:Female Group: 11 CONTROL 0 ppe Fate: (Weeks105)TerminalSacrifice Table:2 MicroscopiOcbservation(scontinued): Adrenal Heart Kidney Liver Hameary Bland Parathyraid SalivaryBland Skin Spleen Uterus -Sinuscidalectasia,cortex,marked -Myocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenophropathy,mild Pelvicmineralizationm,inimal -Repitocytovacuolationo,ultifocalm,inimal -Lobularhyperplasia -Not examined,not in planeof section -Not examined,missing -Fibroma,subcutaneous -Hemosiderasis,mild -Withinnoreillimits Few thanprotocolnumber The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,DoneNarrow,Lung,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Ovary,Pituitary,Trachea,Thyroid,Esophagus,LymphMode (sesentric), Pancreas,Eye. ------------ --- ------ -- --------------- - - - - ------ Animal Number: IR-4591 Sex: Female Group: 1) CMIRM 0 ppe Fate: (Week= 105) Terminal Sacrifice Macroscopic Observations: Microscopic Observations: Adrenal Kidney Liver Lung Lymph Made (sesenteric) Pancreas Pirathyraid Pituitary -No visible lesions. -Corticalvacuolation,local areas, moderate Sinusoidal ectasia, cortex, minimal -Chronic progressive nephropathy, minimal -Portalsonanuclearcell infiltrate,mild Hepatucytealteration,vacuclated,sild -Yascularmineralization,sild -Not examined, missing -Acinar atrophy, focal, minimal -Not examined, not in plane of section -Adenosa The following tissueswe found to be within normal limits: Brain, Spinal Cord, Bwe Narrow, Splm, Heart, Stmach, Small Intestine,Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Mammary Bland, Trachea, Thyroid, Esophagus$ Salivary Blind, Eye. - ---- ---- ---- species: Rat Project kaber: 0261CROO12 Suourized STAR Pqe: iA 257 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObwvations RikerLaboratoriesI,nc. 3N Frr3q24;Tvo Year Oral Toxicity-ftcogeniciSttyudyin Rats --- -- - - --- --- -- -Anisal Number: IR-4592 Sex: Female Group: Fate: (Weeka 68) FoundDead 1) CONTROL 0 pps Table;2 MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Lymph Node (sesenteric) Mammary Bland Parathyraid Pituitary Spleen -Enlarged,0.9 1 1 ca. -Sinuscidalectasia,cortex,moderate -Chronicprogressivenephropathy,minimal -NePitKyteVaCUDIAtiOn#,Ulti4Kal,iiild -Vascularmineraliz4itiosni,ld Perivasculasrononucleairnfiltrates,ild -Mt examined,missing -Lobularhyperplasia,moderate -Notexamined,not in plantof section -Adenoma -Hemosiderosism,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Marro*,Heart,Stomach,Saall IntestineL,arge Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Trachea,Thyroid,Esophagus,Pancreas,SalivaryBlind, Eye. -------------------------- -- - --- Anisal Number:IR-4593 Sex: Female Group: 1) CONTROL 0 ppe --- -- --- --- Fite: (Week=105)TerminalSacrifice MicroscopicObservations: MicroscopicObservations: Adrenal Liver Lung Parathyroid -No visiblelesions. -Sinusoidalectasia,cortex,marked -NeP&tKYtealteritionv,icuolateds,ild Nepatocytaelteritionb,asophilics,ild -Vascularsineralizationm,ild -Notexamined,not in planeof section The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Kidney,Heart,Stomach,Small Intestine, LargeIntestine,UriniryBladder,Aorta,Uterus,Ovary,MammaryBland,Pituitary,Trachea, Thyroid,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. ---------------------------- ---------------- Species:Rat Project Number: 0281CROO12 Sunarized STAR Page: 67 258 Suouriztd SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3124:Too YearOral Toxicity-OncogeniciSttyudyin Rats - AnimalNumber: IR-4594 Sax:Fnale Fate: (Weekt 79) FoundDead -- - -- -- ------Group: 1) CONTROL 0 ppe Table:2 MacroscopicObservations: Kidney UrinaryBladder Pituitary MicroscopicObservations: Adrenal Aorta Kidney Liver Lung Lymph Node (sesenteric) Ovary Pancreas Parathyroid Pituitary SmallIntestine Spleen UrinaryBladder -Rightkidneyappearsslightlymlarged; filledwithyellowmilkyfluid. -Enlarged4,.5 s 2 cm; filledwithlarge,hard calculi. -Hemorrhagicmass, 0.9 1 0.6 ce -Sinusoidalectasia,cortex,moderate One of pair present -Not examined,missing -Pyelon"hritisa,cute,bilateralm,oderate Hydronaphrosisb,ilateral,moderate kphrosis,tubular,bilateral,moderate -Hopatocytealterationv,acualated,mild -Vascularsineralizatiosni,ld -Not examined,missing -Withinnormallimits One of pair present -Not examined,missing -Not exasined,,noitn planeof secti,on -Adenosa -Not examined,missing -HesosiderDsis,moderate -Epitheliahlyperplasiap,apillaryd,iffuse, marked Calculus The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneMarron,Heart,Stomach,Large Intestine,Uterus,MammaryBland, Trachea,Thyroid,Esophagus,SalivaryGland,Eye. ----------------------- -- Anisal Number: IR-4595 Sex: Fesale Group:1 1) MMOL 0 pps Fate: (Week=105)TerminalSacrifice MacroscopicObservations: Pituitary Mammary Gland Pancreas MicroscopicObservations: Adrenal -Hemorrhagicmass, 0.9 ce dia. -Smalllobularmass,2.71 1.51 1.8ce, left &sill&. -Smalllabularmass,I x 0.7 ce, in areaof pancreas. -Sinusoidalectasiapcortex,moderate Species:Rat ProjectNumber:OnICM12 Suew ized STAR Page: is 259 Sumarized SingleTabulatedAnimalReport (continued) IndividualNacroscopicand NicroscopicDbwvations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-ftcogeniciSttyudyin Rats - -- -- -- -- AnimalNumber:IR-4595 Box: Female Group: 1) CONTROL 0 ppe Fate:(Weeks105)TerminalSacrifice Table:2 NicroscapiOEbservation(scontinued): Kidney Liver Lung Himeary 61and Pancreas Pirathyraid Pituitary Uterus -Chronicprogressivenephropathym,inimal -Portalmosonucleacrellinfiltratem,ild Portalbileductproliferatiosni,ld Repatocytealterationv,acuclatedm,ild -Alveolarmacrdphagess,ild -Lobularhyperplasia -Isletcellcarcinoma Partialleyncapsulatewdithinvasionof capsule.Nelldifferentiated. -Notexamined,not in planeof section -Adename -Adenosa Bull circumscribpeadpillarlyesion. The followintgissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,SmallIntestineL,argeIntestine, UrinaryBladder,Aorta,Trachea,Thyroid,EsophagusL,yaphNode (menteric),SalivaryBlind, Eye, Ovary. ------------- -- --- --- ----- AnimalNumber:IR-4596 Sex: Female Group:t 1) CONTROL0 pps Fate:(Week=78) Sacrificeidn extresis NacroscopicObservations: Pituitary NassaryBland Liver Kidney Adrenal NicroscopicObservations: Adrenal Aorta Kidney Liver -Nass,O.Bx 0.6 ca. -Niss,2.5x 2 1 1.5ca,inleftaxilla. -Yerypale -Bilateralplayleandpitted;slightly enlarged0;.4ca dia.cystin right. -Pale,bilaterally -Corticavlacuolationf,ocal,moderate Sinusoidaelctisia,cortex,moderate Redullarcyellhyperplasiao,ultifocalm,ild Corticaldegenerationl,ocalareas,moderate -Nineralizatiomni,ld Nineralizatiamlsoin mediaof an elastic arteryin sectionof sesentersyubmittedfor sesentericlymphnode. -Chronicprogressivenophropithym,arked Cyst,cortical,moderate -Repatocytvoicuolationd,iffusigwkiid Species:Rat ProjectNumber:ONICH012 Somarized STU Page:69 260 Sumarized SingleTabulatedAnimalReportltantinued)IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FN-3924:Too Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 AnimalNumber: IR-4596 Sax: Fasale Group: 1) CONTROL 0 ppe Fate:(Week= 78) Sacrificeidn extresis MicroscopicObservations(continued): Lung LymphNode (sesenteric) Mammary gland Parathyroid Pituitary SalivaryGland Spleen UrinaryBladder -Vascularsineralizatiosni,ld Alveolarsacrophages,minimal -Not examined,missing -Fibroadenosa -Notexamined,not in planeof section -Adenon -Not examined,missing -Hesasiderosis,moderate -Epitheliahlyperplasias,imple,diffuse,mild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,loneNarrow,Heart,Stomach,SmallIntestineL,arge Intestine,Uterus, Ovary, Trachea,Thyroid, Esophagus,Pancreas,Eye. ------------------------------- --------- ---- ----------- - ------ AnimalNumber: IR-4597 Sex: Femile Group: 1) CONTROL 0 pps Fite: (Weekx105)TerminalSacrifice MacroscopicObservations: Adrtnal', MicroscopicObservations: Adrenal Kidney Liver Lung Lymph Node (sesenteric) Ovary Pancreas Parathyroid Spleen Uterus -Rightadrenaleilioged. -Sinusaidalectasiikc,ortiz,marked Medullarycellhyporplasiaf,ocal,sild -Chronicprogressivenephropithy,minimal Pelvicaineriklizatiomni,ld -Portalsononucleatrellinfiltrates,ild Portalbile duct proliferation,mild -Alveolar eacrophales,mild Perivascularsononuclearinfiltrate,mild -No diagnosis, inadequate section -Tubular adenoma, unilateral -Cyst -Not examined,not in plant of section -Hetosiderosis,mild -Nithinnormal limits Fewer than protocol number The followingtissues *ere found to be within normal limits: Brain, Spinal Cord, lone Narrow, Heart, Stomach, Small Intestine,Large Intestine, Urinary Bladder, Aorta, Mammary Gland, Pituitary, Trachea, Thyroid, Esophagus, Salivary Blind, Eye. Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 70 261 Sumarizod SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3924:Too YearDril 7oxicity-OncoveniciSttyudyin Rats Table:2 Animal Number: IN-4596 Sex: Female Broup: 1) COMM 0 pps Fate: (Week=105)TerminalSacrifice MicroscopicObservations: Pituitary Adrenal MicroscopicObservations: Adrenal Brain Heart Kidney Liver Lung Ovary P,increas Parithyroid Pituitary Uterus -Mass,0.7 ce dia. -Leftadrenilgreatlyenlarged. -Sinusoidaelctasia,cortex,marked -Oligodendroglinab,enign -Kyocarditisc,hronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropithy,moderate Pelvicsintralizatiosni,ld Hyperplasiap,elvicepithelium,localareas, sild -Nepatocytveacuclationo,ultifocal,mild Repatocytoalterationb,asophilics,ild -Yascularsintralizatiomni,ld Perivasculaarmenuclearinfiltratem,ild -Tubularadenna -Acinaratrophy,moderate -Not examined,not in planeof section -Adenoma -Cysticglands,moderate The followingtissues*ere foundto be withinnormallimits: SpinalCord,DoneNarrow,Spleen,-StomachS,mall Intestine,Large Intestine,UrinaryBladder, Aorta,MammaryGland,Trichea,Thyroid,Esophagus,LymphNode (amnteric), SalivarySland,Eye. ------------- -------------- -- --- - Animal Number: IR-4599 Sex: Female Broup: 1) CONTROL 0 ppe Fate: (Week=102) Found Dead MacroscopicObservations: Mammary Bland Liver Stomach UriniryBladder Eye MicroscopicObservations: Adrenal Aorta Esophagus Eye -Subcutaneoumsass,2.5 1 2 x I ce, in perinealarea. -Appearsmottled -Areasof onlongatedulceration. -Thickenedwalls;mass 1.5 1 1 ca, with adhesionsto abdominal*all. -No tissuetaken due to postmortemchanges -Sinusoidaelctasia,cortex,marked -Malignantlyspboma,histiocytic -Malignantlyaphosa,histiocytic -Not examined,missing Species:Rat Project Number: 0281CROO12 Sumarized STAR Page: 71 262 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 Animal Number: IR-4599 Six: Fesale Group: 1) CONTROL 0 ppe Fate: (Neeka102) Found Dead MicroscopicObservations(continued): Heart Kidney Large Intestine Liver Lung Lymph Node (mesenteric) Mammary Bland Ovary Pancreas Parathyraid Pituitary Spleen Stomach Thyroid LirinaryBladder Uterus -Nyocarditis,chronicnonsuppurative, oultifocals,ild -Malignantlyaphoma,histiocytic Pelvicmineralizationm,ild Hyperplasia,pelvicepithelium,localareas, mild Nephrosis,tubular,sild -Malignantlyaphoma,histiocytic -Malignantlymphomi,histiocytic Necrosis,local areas, marked -Malignantlyaphosa,histiocytic Hemorrhage,oultifocal,sild -Malignantlyaphoma,histiocytic -Malignantlymphosa,kistiocytic -Malignantlymphoma,histikytic -Malignantlymphoma,histiocytic -Not examined,not in plane of section -Adenosa -Hesosiderosis, miId -Necrosis,sucosal, moderate -Malignantlymphna, hiStiKytiC -Malignantlyaphosa,histiocytic Epithelialhyperplasia,simple,diffuse,sild -Malignantlymphoma,histiocytic The followingtissueswere found to be withinnormal limits: Brain, Spinal Cord,Bone Narrow,Small Intestine,Trachea,SalivaryGland. -------------------------------------------------------------------------------- Anisal Number: IR-4600 Sex: Female Group: 1 1) CDKTROL 0 ppe Fate: (Week= 99) Found Dead MacroscopicObservations: Mammary Gland Liver MicroscopicObseriations: Adrenal Eye Heart -Subcutaneouscystic mass,4 x 3.5 1 2 co, in region of throat;subcutaneous oultilobulamrass,5 1 4 1 2 ce, in right alilla. -Appears mottled -Necrosis,unilateral,marked -Not examined, missing -NYK&rditis, chronicnonsuppurative, wltifocal,mild Species: Rat Project Number: 0261CM12 Summarized STU Pago: 71 263 SummarizedSingleTabulatedAnimalReport teantinutd) IndividualMicroscopicand NicroicopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Yee Oral Toxicity-OncogeniciSttyudy in Rats ------ -----------------Animal Number: IR-4600 Sex: Female Group: Fate: (Weeks ") FoundDead 1) CONTROL 0 ppe Table:2 MicroscopicObservations(continued): Kidney Liver Lung Hameary Gland Ovary Parithyraid Pituitary Spleen -Chronicprogressivneephropithys,ild PelvicmineralizationG,ild Kephrosis,tubular,moderate -Portalsononucltacrellinfiltratem,oderate Portalbileductproliferatiosni,ld Nepatocytvoacuclationo,ultifkal,sild Hopatocytealteration,tosinophilicm,oderate Telangiectasism,ild -Vascularmineralizationm,ild -lwenota,papillary Lobularhyporplasia -Cyst,unilateral -Notexamined,not in plantof section -Adenota -Hesosiderosiss,ild The follovingtissuesoerefoundto be vithinnormallimits: Brain,SpinalCord,Bone harron,Stomach,Beall Intestine,LargeIntestine,,UrinaBrlyadder, Aorta,Uterus,Trachea,Thyroid,Esophagus,LymphNode toesenteric)P,ancreas,SalivarySland. --------------------------------- - -- --- -- --- -- Animal Number: IR-4602 Sex: Femile group: 1 1) CONTROL0 ppe Fite:(Week-105)TerminalSicrifice Macroscopic Observations: Eye Pituitary Adrenal Kidney Microscopic Observations: Adrenal Eye Heart Kidney Liver Lung Parathyraid Pituitary -Cornea appears cloudy. -Raised mass, I co dia. -Right adrenal enlarged. -Pale and pitted. -Sinusoidal ectasia, cortex, marked Cortical degeneration,diffuse, marked -No diagnosis, inadequate section -Nyocarditis,chronic nonsuppuritive, oultifocal,mild -Chronic progressive nephropathy, marked Pelvic aineralization,sild Cyst, cortical -kbpatkyte alteration,basophilic,mild -Hemorrhage, IKal areas, moderate -Not examined, not in plane of sktion -Adenosa --- --------- SpKiIS: Rat Project Nuger: 0291CROO12 Sumarized STAR Page: 73 264 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3q24:Two YearOral Toxicity-WcogenicitSytudyin Rats Table:2 AnisalNumber: IR-4602 Sex: Female Group:( 1) CONTROL0 pps Fate: (Week=105)TerminalSacrifice MicroscopicObservationslcontinued): Spleen Uterus -Hesosiderasisa,ild -Withinnormallimits Fever than protocolnumber The followingtissuesmere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder, Aorta,Ovary,MammaryGland,Trachea,Thyroid,Esophagus,Lymph Node (sesenteric),Pancreas, SalivaryGland. ---------------------------------- --- - Animal Nueber:IR-4603 Sex: Female Group: 11 CDKTRL 0 ppe Fate: (Weeks105) TerminalSacrifice MicroscopicObservations: Liver Skin MicroscopicObservations: Adrenal Heart Kidney Liver Lung Aa@Bary Gland Parathyroid Pituitary Skin Spleen -Circularaisedlesion,0.6co dia.,left laterallobe. -Hairlosson forelimbs. -Sinusoidalectasia,cortex,moderate Corticaldegenerationd,iffuse,moderate -Nyocarditisc,hronicnonsuppurative, oultifocals,ild -Pelvicmintralizmtiosni,ld -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatioani,ld Nepatocytoalterationv,acuolated,mild -Perivasculasrononucleiinrfiltratem,ild -6alactocell -Notexamined,not in plantof section -Adenoma -Acanthosism,ild -Hemosiderasiss,ild The followingtissuesmerefoundto be withinnormallimits: Brain,SpinalCord,DoneNarrow,Stomach,SmallIntestine,Large Intestine,UrinaryBladder, Aorta,Uterus,Ovary,Trachea,Thyroid,Esophagus,LymphNode (sesenteric)P,ancreas, SalivaryGland,Eye. - -- ----------------- Species:Rat Project Number: 0281CROO12 SummarizedSTAR Pagt:74 2 6 5 Smarized SingleTabulatedAnimal Report(continued)___ IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H Ffl-3924T:va YearOral Toxicity-WcogenicitSytudyin Rats - --------AnimalNumber: IR-4604 Sax: Female Group: 1 1) CONTROL0 ppe Fate: (Neekz105)TerminalSacrifice Table:2 MicroscopicObservations: Adrenal MicroscopicObservations: Adrenal Aorta Esophagus Kidney LargeIntestine Liver Ovary Parithyroid Uterus -Leftadrenalenlarged. -Sinusoidalectisia,cortex,marked -Not examined,missing -Not examined,missing -Chronicprogressivenephropatyh, sild Pelvicmineralizationm,ild -Not examined,missing -Portalbileductproliferatiosni,ld Hlp8tKyte VACUOI&tiOno,ultifocal,sild Hyperplasticnodule -Cyst,unilateral -Notexamined,not in planeof section -Withinor"l limits FeNu than PfCtKOI number The folloningtissuesverefoundto be sithinnormallimits: Brain,SpinilCord,BoneNarrou,Spleen,Heart,Lung,Stomach,Small Intestine,UrinaryBladder, MammaryGland,Pituitary,Trachea,Thyroid,LymphNodi'loesentwic),Pancreas,SalivaryGland, Eye. ---------------------------- ---- - ------------- --- - - --------------------------- AnisalNumber: IR-4605 Sey,:Female Sroup'. 1) CONTROL 0 pps Fite:(Weeks 77)Sacrificeidn extresis MicroscopicObservations: Kidney Lung MicroscopicObservations: Adrenal Heart Kidney Liver Lung -Slightlypitted -Rightapicallobeconsolidateadnd sombit enlarged;possiblytumor,@ass, chronicpneumonia. -Necrosis,localareas,moderate Hmtopoitsis,extramedulliroyu,ltifocal, mild -NYK&rditis,chronicnonsuppurative, oultifocal,moderate MalignantlyMphO&,lylphKytiC -Chronicprogressivenephropithy,moderate Pelvicmineralizationm,inimal -Hep4tKytt VSCUDI&tiOn,sidzonal,moderate Malignantlyaphoma,lylphKytiC -Vascularmineralizationm,ild Malignantlymphoma,lymphKytiC Largecircumscribemdass vithatasive necrosis. Species:Rit Projtct Number: 031CROO12 Summarized STAR Page: 75 266 Sumarized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year OralToxicity-OncogenicitSytudyin Rats -- --------------------------- --- Animal Number: IR-4605 Sex: Female Group: Fate:(Week= 77) Sacrificeidn extromis 1) CONTROL 0 ppe Table:2 MicroscopicObservations(continued): Ovary Parathyraid Pituitary SpinalCord Sp-leen UrinaryBladder -Cyst,unilateral -Not exasinedgnot in plantof section -Adenama -Niilaciilio,calareas,moderate -Resasiderasissi,ld -Epitheliahlyperplasias,imple,diffuse, moderate The followingtissueswere foundto be withinnormallimits: Brain,Bone Narrow,Stomach,SmallIntestine,LargeIntestine,Aorta,Uterus,MammaryGland, Trachea,Thyroid,Esophagus,LymphNode (sesonteric)P,ancreas,SalivarySland,Eye. ---------------------------- - ----------- Animal Number: IR-4606 Sex: Female Group: 1) CONTROL 0 ppe Fate: (Weeks105) TerminalSacrifice MacroscopicObservations: Mammary Gland Pituitary Uterus MicroscopicObservations: Adrenal- Heart Kidney Liver Lung LymphNode (sesenteric) Mammary 61and Ovary Parathyroid Pituitary Uterus -Small miss, 1.4 ce dia., left lateral area. -Enlirged;circulardarklesion,0.4 ce dia. -Darkfluidfilledlesion,0.5x 0.6ca,right horn. -Sinasoidaelctasialcortex,mild Corticaldegenerationb,ilateral,moderate Pheochrosocytomab,enign,unilateral -Myocarditisc,hronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropathy,mild Pelvicsintralizatiomni,ld -Repitocytveicualationo,ultifocalm,ild Hepatocytealteration,vacuolitedm,ild -Pigment,moderate Scatteredsmallfociof dark brow pigment-ladensacrophageswithin alveoli. -Hemorrhage,sild -Adenocarcinosa -Not examined,missing -Notexamined,not in planeof section -Adenosa -Hydrosetram,arked The followintgissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneKarroN,Spleen,Stomach,SmallIntestineL,argeIntestine, - -- --- ---- - Species:Rat Project Number: 0261CROO12 SummarizedSTAR Page: 76- 267 Sumarized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H Ffl-3924T:oo YearOral Toxicity-bcogenicitSytudyin Rats Table:2 Animal Number: IR-4606 Sax: Female Broup: 1) CONTROL 0 ppe Fitt: (Weekz105)TerminalSacrifice MicroscopicObservations(continued): The followingtissues*erefoundto be withinnormallimits(continued): UrinaryBladder,Aorta,Trachea,Thyroid,Esophagus,PancreasgSalivaryBlind,Eye. -- -- -------------------- Animal Nuaber:IR-4607 Six: Female 6roup: 1) CONTROL 0 ppe Fite: (Week-.-4.0)Sacrificeidn extresis MicroscopicObservations: Soft Tissues(neck) Lymph Node Liver Spleen MicroscopicObservations: Adrenal Aorta Done Narrow Esophagus Eye Kidney Liver Lung LymphNode (sesenteric) Mammary 61&nd Ovary Parathyroid Salivary61and Spleen Stomach Thyroid Uterus -Reddenedglandlike structuresp,ossibly enlargedlymphnodesor salivary glands. -Enlargedaxillary,hepatic,sesentericand internaliliaclymphnodes. -Possiblyslightlypale. -Considerablyenlarged. -Malignantlyaphota,lymphocytic -malignantlymphoma,lymphocytic -Malignantlymphola,lymphocytic -No diagnosis,inadequatesection -Malignantlymphosa,lymphocytic -Malignantlyaphona,lymphkytic -*alignantlysphosa,lyaphocytic -Malignantlymphoma,lyaphocytic Hemorrhage,localareas,sild Abscess -Hemorrhage,moderate Malignantlymphoma,lyaphocytic Massiveonlargeentof node by mature appearinglymphocytes.All othernodes esimined*ere similarilyinvolved. -Malignantlyaphosa,lyaphocytic -Malignantlyaphosa,lymphocytic -Not examined,not in planeof section -Not examined,missing -Malignantlyaphola,lyaphocytic -Hemorrhage,subsucosal,moderate Malignantlymphosa,lymphkytic -Malignantlymphosa,1YEPhKytiC -Malignantlyaphoma,lylphKytiC The follaisintgissueswere foundto be vithinnormallimits: Brain,SpinalCord,Heart,SmallIntestineL,arge IntestineU,rinaryBladder,Pituitary, Species:Rat Project Number: ONICROO12 Smarized STAR Page:77 268 SummarizedSingleTabulatedAnimal Report(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-WcagenicitSytudyin Rats --- --- -- --- --- --- - - -- -- -- - -- -AnimalNumber: IR-4607 Sex:Female Group: ( 1) CONTROL0 ppe Fate:(Weekz40)Sacrificeidn extreais Table:2 MicroscopiOcbservatmis (continued): The followintgissueswe foundto he withinnormallimits(continued): Trachei,Pancreas. --- ------------ -- AnimalNumber: IR-4609 Sex:Fosale Group:t 1) CONTROL0 ppe Fite:lNeekz.105T)erminalSacrifice MacroscopicObservations: Pituitary Mammary Gland MicroscopicObservations: Adrenal Heart Kidney Large Intestine Liver Lung Mammary Blind Pancreas Parathyroid Pituitary Spleen Thyroid Uterus -Raisedmass,I ce dia. -Kass,5 x 4 ce, throatareas3' ca dia.,left axilla. -Sinusoidaelctasia,cortex,moderate -Kyocarditisc,hronicomsuppurative, oultifocasli,ld -Chronicprogressivneophropathys,ild Pelvicmineralizatiomno,derate -Not examined,missing -Portalsonmuclearcellinfiltratem,ild Portal.bildeuctproliferatiomni,ld Nepatocytveicuolationo,ultifocalm,ild -Pneumoniai,nterstitiaclh,ronic,oultifocal, mild -Carcinoma Highlycellularveryundifferentiatteudmor. -kinar atrophy,moderate -Notexamined,not in planeof section -Adenota -Nesosiderosism,ild -C cell idenoma -Withinnormallimits Feverthan protocolnumber The followintgissueswerefoundto be withinnormallimits: Brain,SpinalCord,DoneMarro*,Stomach,SmallIntestineU,rinaryBladder,Aorti,Ovary, Trachea,Esophagus,LymphNode (sesenteric)S,alivaryGland,Eye. --- ---------- - - --- --- -------- -------------- Species:Rat Project Number: 0281CROO12 SummarizedSTAR Page: 70 269 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Tuo YearOral Toxicity-OncogeniciSttyudyin Rits -- ---------------------------------AnimalNumber: IR-4611 Sex: Female Broup: Fate: (Weekz105)TerminalSacrifice 1) CONTROL 0 ppe Table:2 MacroscopicObservations: Hismary Gland MicroscopicObservations: A4renil Li.ver Lung Mammary Gland Par,ithyroid Pituitary -Largelobularmass,10 1 7.5 1 5 ca. -Sinusaidaelctasia,cortex,marked Corticaldegenerationl,ocalareas,moderate -Nepatocytveacuolationo,ultifocals,ild Hapitacytealteratione,asinophilicm,ild -Hemorrhageo,ultifocal,mild Alveolareacrophigeso,ultifocals,ild 4ibroadenona -Notexamined,not in planeof section -AdLnoma The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, Large Intestine,LlrinarByladder,Aorta,Uterus,Ovary,Trachea,Thyroid,Esophagus, LymphMode (mesenteric)P,ancreas,SalivaryBlind,Eye. ------------------------------ --- ------ ---- --- -- - - -- -------- AnimalNumber: IR-4612 Sex: Female Group: 1) CONTROL 0 ppe Fite: ikeekz105)TerminalSacrifice MicroscopicObservations: Pituitary Hismary Gland MicroscopicObservations: Adrenal Eye Liver Lung Mammary Gland Parithyfoid Pituitary Uterus -Raisedmass,0.7 to dia. -Hass,3 ce dia.,leftaxilla;4 ca dia., rightaxilla; 7 x 6 x 2 ca,rightside. -Sinusaidalectasia,cortex,moderate -No diagnosis,inadequatesection -kpatocytevacuolationo,ultifocalm,ild -Nmrrhage, diffuse,marked Alveolareacrophages,mild -Galictocele Fibroadenosi Fibroadenosa Two tumorspresent. @Mt examined,not in plantof section -Adenoma -Vithinnormallimits Feuer than protocolnumber The followingtissuesmerefoundto be withinnormalliaits: Brain,SpinalCord,DoneNarrow,Spleen,Kidney,Heart,StDaach,SmallIntestine, -- ------------------------- Species:Rit Project Number: 0281CROO12 Sumarized STAR Page: 79 270 SummarizSeidnglTeabulateAdnisaRleport(continued) IndividuNaalcroscopaincdNicroscopOibcservations RikerLaboratoriIensc,.3N FN-3924T:ooYearOralToxicity-OncogenSitcuidtyiynRats Table2: AnimaNlumberI:R-4612 Sex:FemaleGroup:( 1)CONTRO0Lppe Fate:(Week1-05)TerminaSlacrifice NicroscopOibcservatiolncsantinued): Thefollowitnigssue*serefoundtobewithinnormallimits(continued): LargeIntestinUer,inarByladderA,ortaO,varyT,racheaT,hyroidE,sophagus, LymphMadeloesenteriPca)n,creasS,alivarGyland. -------------------------- - -- -- - AnimaNlumberI:R-4613 Sex:FemaleGroup:11CIN(T0ROpLpe Fate:(Week8z1)Sacrificienedxtrnis NacroscaOpbiscervations: Pituitary NasearGyland Liver NicroscoOpbiscervations: Adrenal Esophagus Kidney LargIentestine Liver Lung RamairGyland Parathyroid Pituitary Spleen UrinirByladder Uterus -Somewheantlarged -Kass1,0x 0 1 5 ca,ingainaarleas;urface ulcerated. -Appeaprasls -Reestopoieessitsr,iewullasriyl,d Sinusoiedcatlasitao,rtes,ild Corticvaalcuolatifokna,l,mild -Notexaminemdi,ssing -Pelvimcineralizatsiiolnd, Hyperplaspieal,viecpitheliluomc,aalreas, mild -Notexaminemdi,ssing -kpitacyvtaecuolatipoenr,iportmiill,d Necrosiosu,lti4ocmaill,d Hematopoieesxitsr,asedullmairlyd, -Hmrrhages,ultifocsaill,d Pneumonian,terstitciharlo,niocu,lti4ocal, sild -Lobulhayrperplasia -Notexaminendo,tinplanoefsection -Adenosi -Nesatopoieesxitsr,isedullianrcyr,eased, moderate -Epithelhiyaplerplassiiam,pled,iffusmei,ld -Withinnormallimits Fewetrhinprotocnoulmber Thefollowitnigssuewserefountdobewithinnormallimits: BrainS,pinaClordB,we NarrowH,eartS,tomacShm,allIntestiAnoer,taO,varyT,rachea, ThyroiLdy,mpNhode(sesenterPiacn)c,reaSsa,livaGrlyandE,ye. - - -- ------- SpecieRsa:t ProjecNtumber0:281CROO12 SummariSzTeAdRPages:o 271 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year OralToxicity-OncogeniciSttyudyin Rits - - --- ----------------------------------- -Animal Number: IR-4614 Sex: Female Group: 1) CONTROL 0 ppB Fate: (Week=105)TerminalSacrifice Table,2 MicroscopicObservations: RisairyGland Uterus MicroscopicObservations: Adrenal Kidney Liver Mammary Bland Pancreas Pirathyraid Pituitary SpinilCord Spleen Thyroid Uterus -Missin perintalire&;possiblemilkcyst. -Largegelatinouscervicalmiss,2 cm dia. -Sinuscidalectisia,cortex,moderate -Pelvicmineralizationm,inimal Chronicprogressivenephropathy,sild -Hepatocytveicualitions,ultifocils,ild -Adenecircincea -Acinaratrophy,sild -Not examined,not in planeof section -Adenota -No diagnosis,inadequatesection -Hetasiderosis,ild -Ultisobrinchicaylst -Polyp Thiswas the miss at cervixnotedit necropsy. The followingtissueswere foundto be withinnormallimits; Brain,Bone Narrow,Heart,Lung,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder, Aorta,Ovary,Trichea,Esophagus,LymphNode (sesenteric)S,alivaryGland,Eye. ------------------------- --- --------- Animal Number: IR-4615 Sex: Female Group: 1) CONTROL 0 pps Fite:(Week=105)TerainalSicrifice MicroscopicObservations: -No visiblelesions. MicroscopicObservations: Adrenal Aorta Kidney Liver -Sinusaidielctasia,cortex,marked -Not examined,missing -Pelvicsinerilizatiomni,nimal -Portiblileductproliferatiosni,ld Repatocytealteritionv,acualateds,ild Hepatocytealteration,basophilicm,ild Lung -Pneumoniai,nterstitialc,hronic,mild Alveolarmacrophages,mild Mammary Gland -Salactocele Parathyroid -Not examined,not in planeof section Spleen -Hemosiderosiss,ild Uterus -Withinnormallimits Fewerthinprotocolnoder -- --- ------------ - ------------- --------------- --- -- -- Species:Rit Project Nuaber: 0261CROO12 Summarized STAR Page: 81 272 SuamarizedSingleTabulatedAniul Report(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-UncogeniciSttyudyin Rats Table:2 Animal Number: IR-4615 Sex: Female 6roup: ( 1) CONTROL0 pps Fate: (Week=105)TerminalSacrifice MicroscopicObservations(continued): The followingtissueswerefoundto be withinnormallitits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Ovary,Pituitary,Trachea,Thyroid,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryBland,Eye. --------------- ---------- - -- ---- --------- - --------- Animal Number: IR-4616 Bei:Female Sroup: 1) CONTROL 0 pps Fate: lneekz105)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Heart Kidney Liver Lung Mammary Bland Ovary Parathyroid Spleen -No visiblelesions. -Corticaldegenerationu,nilateralm,arked -Myocardiaflibrosisf,ocal,aild Nyocarditisc,hronicnonsuppurative, oultifocalg,ild -Chronicprogressivenephropathy,sild Pelvicminerilizitiomni,nimal -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationa,ild Nepatacytveacuolations,ultifocals,ild Nepatocytealterationv,icualateds,ild -Perivasculasrononuclearinfiltratem,oderate Vascularsineralizationm,ild Alveolareacrophages,mild -Not examined,missing -Cyst,unilateral -Not examined,not in planeof section -Hemosiderosis,mild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Stomach,Small Intestine,LargeIntestine,UrinaryBladder, Aorta,Uterus,Pituitary,Trachea,Thyroid,Esophagus,LymphNode (nesenteric)P,ancreas, SalivaryGland,Eye. ---------------------------------------------------------------- -- - ---------- Species:Rat Project Number: 0261CROO12 Suew iztd STAR Page: 62 273 SummarizSeidnglTeabulatAendimalRepor(tcontinued) IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3H FN-3924T:woYearOralToxicity-OncogenSitcuidtyiynRats Table:2 Animal Number: IR-4617 Six:Fosale Broup: 1) CONTROL 0 ppe Fate: (Neekc 73) Sacrificed in extresis Microscopic Observations: Ovary Liver MicroscopicObservations: Adrenal Liver Lung Mammary Bland Ovary Parathyroid Pituitary -Hemorrhagic mass, 5 ce dii., left ovary. -Palo;leftlaterallobedarkred. -Sinusaidaelctasia,cortex,sild One of pair present -Portalmonanucleacrellinfiltratem,ild Necrosis,diffuse,marked Massivenecrosisof one lobe with compensatoryincreasein mitosesin another lobe. -Yascularmineralizationm,ild -Not examined,missing -Leiomyota LargeNelldifferentiatendeoplasm,mostly necrotic,probablyarisesfrom an oviduct. -Not examined,not in plantof section -Notexaminedm,issing Thefollowintgissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, LargeIntestine,UrinaryBladder,Aorta,Uterus,Trachea,Thyroid,Esophagus, LymphNode (mesenteric)P,ancreas,SalivaryBland,Eye. ----------------------------------------------------- -- ------ --- ------------------- Animal Number: IR-4619 Sex: Female Group: 1) CONTROL 0 ppe Fate:(Weekz 93) Sacrificeidn extresis MacroscopicObservations: Pituitary Mammary Gland MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung MammaryGland Parathyroid Pituitary - -- ---------------- -Raisedmass,1.1 ce dia. -Largeulceratedmass,10 1 7 s 9 ce, right axillaryarea. -Sinusoidaelctisia,cortex,mild -Not examined,missing -Pelvicmineralizationm,inimal -Portalsononucleacrellinfiltrates,ild -Yascularmineralizationm,ild Alveolarmatrophages,sild Perivascularsmanuclear infiltrate,sild -Not examined,missing -Notexamined,not in planeo4 section -Adenosa Species:Rat ProjectWeber: OnICROO12 Summarized STAR Page: c 274 SummarizSeidnglTeabulatAendimaRleport(continued) IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3H Ffl-3q2T4w:oYearOralToxicity-WcogeniSctiutdyyinRats --- ----------------AnimalNumberI:R-4618 Sex:FemaleGroup: 1)CONTROL0 ppe Fate:(Week=93)Sacrificeidn extresis Table2: MicroscopiOcbservatio(ncsontinued): Skin Thyroid UrinarByladder -Fibromas,ubcutaneous Largeneoplaswmithextensivceallagen formationl,argeportionecrotic.Described asmanirylesionbutno mammartyissue presentin section. -Ultisobranchciyaslt -Epitheliahlyperplasisai,mple,diffuses,ild Thefollowintgissue*serefoundto be withinnormallimits: Brain,SpinalCard,BoneNarrowS,pleenH,eart,StomachS,mallIntestineL,argeIntestine, Aorta,Ovary,TracheaL,ymphNode(onenteric)P,ancreasS,alivarByland,Eye,Uterus. ------------------------- -- AnimalNumber:IR-4617 Sex:FemaleGroup: 1)CONTRO0L ppe Fate:(Meek=64)FoundDead NacroscopOibcservations: Spleen Liver Pituitary MicroscopiOcbservations: Adrenal Esophagus Eye Kidney Liver Lung LymphNode(sesenteric) MammarGyland Parathyroid Pituitary SalivarByland Spleen Stomach UrinaryBladder -Slightleynlarged -Palewithin irregulasrurfacoen alllobes. -Enlargewdithhemorrhagifcoci. -Necrosisd,iffusem,arked Malignanltymphomah,istiocytic -Notexaminedm,issing -Notexaminedm,issing -Nephrosist,ubularm,arked -Portablileductproliferatiomna,rked Necrosisl,ocalareas,moderate malignanltymphomah,istiocytic -Vasculamrineralizatisoinl,d Malignanltymphosah,istiocytic -Hemorrhagtei,ld -Salictocele -Notexaminedn,ot inplantof section -Adenoma -Sialadeniticsh,ronicm,oderate -Malignanltyaphomah,istiocytic Knatopoiesise,xtramedullairnyc,reased, moderate -Necrosis,ucosalm,ild -Epithelihaylperplasisai,mpled,iffusem,ild Thefollowintgissue*serefoundtobe withinormallimits: Brain,SpinalCord,loneNarrowH,eart,SmallIntestineL,argeIntestineA,orta,Uterus,Ovary, speciesR:at ProjecNtumber:0281CROO12 SummarizeSdTARPage:84 275 SummarizedSingleTabulatedAnimalReport (continued)-IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3q24:Two YearOral Toxicity-OncogeniciSttyudyin Rats -----------------AniailNumber: IR-4619 Sex: Female Broup: ( 1) CONTROL0 pps Fate: (Reekz 64) FoundDead Table:2 MicroscopicObservations(continued): Thefollowingtissueswerefoundto be withinnormallimits(continued): Trachea,Thyroid,Pancreas. --- ------------- ----------- - ----------- Animal Number: IR-4621 Sex: Female Broup: 1 1) CONTROL0 pps Fate: (Neekx..99S)acrificeidn extresis MacroscopicObservations: Pituitary Mammary Gland Liver Adrenal MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lung MisairyGland Par.ithyraid Pituitary Spleen -Slightlyenlarged -Subcutaneousulceratedmass, 5 x 4 x 1.5 CA, in rightaxilla. -Appearsmottled. -Slightlyenlarged. -Corticalvacuclationf,ocal,mild Sinusaidalectasia,cortex,marked -Not examined,missing -Hyacarditisc,hronicmmsuppurative, oultifocalm,ild -Chronicprogressivenephropathy,sild Pelvicmineralizatiosni,ld Kephrosisttubular,moderate -Portalsononucleacrellinfiltratem,inimal Repatocytevacuclationp,eripartal,sild -Alveolareacrophagess,ild Perivasculasrononucleairnfiltratem,ild Hemorrhage,localareas,sild -Fibroadenoma Salactocele -Not examined,not in plantof section -Adenona -Himatopciesise,xtramedullaryi,ncreased, mild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Done Narrow,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder, Aorta,Uterus,Ovary,Trachea,Thyroid,LymphNode (mosenteric)P,ancreas,SalivaryBland,Eye. - -------------------- - ------------ ------- Species:Rat Project Number: ONICROO12 Smarized STAR Page: 05 276 SummarizedSingleTabulatedAniul Report tcontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3q24:Too Year OralTDxicity-OncogeniciSttyudy in Rats Table:2 AnisilNumber:IR-4622 Sex: Fesale Group: 1) CONTROL 0 pps Fate: (Week= 62) FoundDead MicroscopicObservations: Skin Mammary gland Kidney Pituitary cung MicroscopicObservations: Adrenal Aorta Kidney Liver Lung HismaryBlind Parithyroid Pituitary Skin -Smallcircularlesionon back;slighthair lossan leftlateralside. -Mass,2 ce dia.,rightasillaryarea;1.5ce dia.,leftinguinaalrea. -Raisedarea,0.3ce dia.,on surfaceof right kidney;appearsfluidfilled. -Darkred gelatinousmass. -Slightlmyottled -Sinusoidaelctasia,cortex,marked -Notexamined,missing -Chronicprogressivenephropithym,oderate Pelvicsinerilizatiomno,derate Hyperplasiip,elvicepitheliuml,ocalareas, sild -Nepatocytveicuolationp,eriportalm,oderate -Alveolarmicrophagesm,ild -salactactle -Notexamined,not in planeof section -Not examined,missing -Ulcer,focal,moderate The followintgissueswerefoundtD be withinnormallimits: Brain,SpinilCord,BoneNarrow,Spleen,Heart,Stomach,BeallIntestineL,argeIntestine, UrinaryBladder,Uterus,Ovary,Trachea,Thyroid,EsophagusL,ymphNode (wsenteric),Pancreas, SalivaryBlind,Eye. ------------------------------------------ ---- ---------- --- ---------------------AnimalNumber:IR-4623 Sex:Fmle Broup:1 1) CONTROL0 ppe Fite:lneekz96)Sacrificeidn extresis MicroscopicObservations: Eye Mammary Gland Adrenal MicroscopicObservations: Adrenal Esophagus Eye Kidney Liver -Opacityr,ighteye. -Multilobulmaarss,It x 12 x 3 ca,right axilla. -Appearenlarged -Sinusoidaelctisia,cortex,marked -Mt examined,missing -Cataractu,nilateral -Pelvicsineralizatiomni,nimal -Portalsononucleacrellinfiltrates,ild Hipatocytaelterationv,iicualatwm,ild Species:Rat ProjectNumber: 0281CROO12 Sumarized STARPage:w 277 SummarizSeidnglTeabulateAndimalRepwt (continued) IndividualMacroscopicand MicroscopicObservations Riker Laboratories,Inc. 3H Fil-3?24T:oo Year Oral 7oxicity-OncolenicitSytudyin Rats -- --------------- ------------------------ Animal Number: IR-4623 Sex: Female Group: 1 1) CONTROL 0 pps Fate: (Week= 96) Sacrificedin extresis Table:2 MicroscopicObservationstcantinued): Lung Lymph Node (sesenteric) Mammary Sland Pituitary Thyroid Uterus -Pneumonia,interstitialc,hronic,oultifocal, sild Alveolarmacrophages,sild Perivascularsononuclear-infiltratmei,ld -Sinuscidalectasia,moderate -Fibroadenoma -Adenomi 4allicularhyperplasiac,ystic,unilateral, sild -Within normal limits Fewer thin protocol number The followingtissueswere foundto be withinnormallimits: Brain, Spinal Card, Bane Narrow, Spleen,Heart, Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta, Ovary, Trachea,Parathyroid,Pancreas,SalivaryGland. ---- ----------- -------------- - - -- --- --- --- --- - Animal Number: IR-4624 Sex: Female Group: 1) CONTROL 0 pps Fate: (Weekz100)Sacrificedin extresis MacroscopicObservations: Pituitary Mammary Gland Lung MicroscopicObservations: Adrenal Kidney Liver Lung Mammary Sland Ovary -Hemorrhagicmass, 0.6 ce dia. -Ulcerated,cystic*ass,4 1 4 1 3.5 ce, in leftaxilli-throaatrea; oultilobala&rass,6.5 1 5.5 x 3 ce, in right inguinalarea. -Raisedcircularnodule,0.6 ce dia.,in left lobe. -Sinuscidalectasia,cortex,moderate -Chronic progressivenephropathy,minimal Pelvicmineralizationm,ild -Portalmanonuclearcell infiltrateg,ild Portalbileduct proliferations,ild Hepatacytevacualation,oultifocal,sild -Pneumonia,interstitialc,hronic,sultifocal, mild Metastatic neoplasm Large metastasisof mammary adinkarcinosa. -Fibroadenosa Adenocarcinoma -Cyst,unilateral Species: Rat Project Number: 0201CROO12 Summarized STAR Page: of 278 Sumarized SingleTabulitedAnimalReport lcantinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FK-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats --- -- -----------------Animal Number: IR-4624 Sex: Female Group: Fate: (Week=100)Sacrificedin extresis 1) CONTROL 0 ppe Table:2 MicroscopicObservations(continued): Parathyraid Pituitary Spleen -Not examined,not in planeof section -Adenosa -Hesitapoitsietx,tratedullaryi,ncreased, moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinilCord,Bone Narrow,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Trachei,Thyroid,Esophagus,LymphNode (sesenteric)P,ancreas, SalivaryBland,Eye. Animal Number: IR-4625 Sex: Female Group: 1 1) CONTROL0 ppe Fite:(Weekz100)Sacrificeidn extresis MacroscopicObservations: Pituitary Mammary Gland Adrenal Kidney MicroscopicObservations: Adrenal Esophagus Eye Heart Kidney Liver Lung Mammary Bland Parathyroid Pituitary Spleen -Enlargeddue to raisedmass,1.2 ca dia. -Cysticmass,2 ce dia.,leftaxilli. -Both appearenlarged. -Somewhatpitted -Sinusoidalectasia,cortex,marked Corticaldegenerationl,ocalareas,sild -Nottiasined,missing -No diagnosis,inadequatesection 4yocarditis,chronicnonsuppuritive, oultifocalm,ild -Chronicprogressivenephropathy,marked -Portalsononucleacrallinfiltrates,ild Hepatocytevacualationo,ultifocal,minimal -Hemorrhage,localareas,moderate -Fibroadenosa -Notexamined,not in planeof section -Adenama -Hemosiderosism,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Karroo,Stomach,Small Intestine,LargeIntestine,UrinaryBladder, Aorta,Uterus,Ovary,Trachea,Thyroid,LymphNode (sesenteric)P,ancreas,SalivaryBlind. ----- ------ - -------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: Be 279 SuaaarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3W FN-3924:Tva YearCril Toxicity-OncogeniciSttyudyin Rats -- - ---- ---------------------------AnimilNuaber: IR-4626 Sex: Female Group: Fate: (Week=105)TerminalSacrifice 1) CONTROL 0 ppa Table:2 MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Parithyroid Pituitary Spinal Card Spleen -Raised&ass,0.9 ca dia. -Pheochrosocytomab,enign,unilateral -Chronicprogressivenephropathy,aoderate Pelvicmineralizationa,oderate -Hepatocytveacuolationo,ultifocals,ild -Yascularmineralizationm,ild -Not examined,not in planeof section -Adenoma -Not examined,aissing -Heaosiderosism,ild The followingtissueswerefoundto be withinnoraallimits: Brain,BoneNarrow,Heart,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder,Aorta, Uterus,Ovary,HaaaaryBland, Trachea,Thyroid,Esophagus,Lymph Mode (sesenteric),Pancreas, SalivaryGland,Eye. --------------------------- - - --------------- --------- -- ---------- Aniaal Number: IR-4627 Set: Femile Broup: 1) CONTROL 0 ppe Fate: (Week=105)TerminalSacrifice MacroscopicObservations: Pituitary hasairyBlind MicroscopicObservations: Adrenal Heart Kidney Liver Lung Hasaary Gland Ovary -Nasig1 1 0.6 ca. -Firmaiss,5.5 x 4 x 3.5ca, rightlateral area; lobularmass,7 x 6 1 5 ca, leftaxilla. -Sinusoidaelctasia,cortex,moderate Medullarycallhyperplasiao,ultifocala,ild -Myocarditisc,hronicnonsuppurative, aultifocalm,ild -Chronicprogressivenephropathy,aoderate -Portalaononucleacrallinfiltrates,ild Portilbileductproliferationm,oderate Hepatocytealteration,basophilic,moderate -Yascularmineralizationa,ild Alveolarsacrophigesa,ild Perivasculaaronanucleairnfiltrates,ild -Adenocarcinoma Neoplasmarisesin severalplacesin a fibroadenosa. -Tubularadenoeiiu,nilateral Cyst,bilateral --- --------- Species:Rat ProjectWar: ONICM12 SuaaarizedSTAR Page: 69 280 SummarizSeidnglTeabulatAendimaRleport(continued) IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3K FN-3924T.w,oYearOralToxicity-WcoginiSctiutdyyinRats Table:2 AnisaNlumberI:R-4627 Sex:FeealeGroup: 1)CONTRO0Lpps Fite:(Neek1s05)TerminaSlacrifice MicroscopOibcservatio(ncsontinued): Pancreas Parathyroid Pituitary Skin Uterus -Islectelliidenoma -Notexaminedn,otinplaneofsection -Adenow -Fibromsau,bcutaneous -Cystigclandsm,ild Thefollowitnigssuesserefoundtobewithinnormallimits: BrainS,pinaClord,Bat NarrowS,plm, StomachS,mallIntestinLea,rgeIntestine, UrinarByladderA,ortaT,racheaTghyroidE,sophaguLsygmphNode(sesenteriSca)l,ivarGyland, Eye. ------------------AnisaNlumberI:R-4626 Sex:FesileGroup: 11CONTRO0Lpps Fate:(Week1=05)TerminaSlacrifice MacroscopOibcservations: Pituitary MammarGyland MicroscopOibcservations: Adrenal Esophagus Kidney Liver Lung MammarBylind Parithyraid Pituitary -Mass1,.2cedia. -Smalnlodule1,.5cedia.,rightalilli; possiblmeilkcyst. -Sinusoideacltasiaclortexm,oderate -Notexaminemdi,ssing -Pelvimcineralizatimoin,imal -Portablileductproliferatisoinl,d Htpatocyatleteratiovna,cualitesdi,ld Hepatocyvtaecualatioounl,tifocasli,ld -Vasculasrintralizitisoirl,d -salactacele Adenonap,apillary Smallhighlcyellulanreoplaslmyingadjacent toseverallargegalactocoels. -Mt examinedn,otinplantofsection -Adenoma Thefollowitnigssuewserefoundtobewithinnormalimits: BrainS,pinaClord,BoneNarrowS,plm ,Heart,StomachS,mallIntestinLea,rgeIntestine, UrinarByladderA,ortaU,terusO,varyT,racheaT,hyroidL,ymphNode(msentericP)a,ncreas, SalivarBylindE,ye. - -- --- --- --- - SpeciesR:at ProjecNtumberO:NICAN12 SummarizSeTdARPage:90 281 SwmarizeSdinglTeabulatAendimalReport(continued) IndividuMaalcroscopaincdMicroscopoibwc vations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-WcogenicitSytudyin Rats ----- --- --- - ------------AaiailNumber:IR-4633 Six:Female Group: Fate:(Week= 63)Sacrificedin extremis 1) CONTROL 0 pps Table:2 MicroscopicObservations: Liver Spleen Hiseary Gland MicroscopicObservations: Adrenal Aorta Esophagus Kidney Liver Lung Mammary Gland Parathyroid SalivaryBland Spleen -Very pale -Slightlyenlarged -Largesubcutaneousmass, 6 1 10 x 2.5 ca, withnecroticareas,containing dark brownfluid,ventralabdomen. -Hematopoiesise,xtratedullaryc,ortical,mild Siousoidalectasia,cortex,mild -Not examined,missing -Not examined,missing -Chronicprogressivenephropathy,minimal Yacualationc,onv.tub. tpitheius,moderate -Repatocytveicualitionc,entrilobularm,arked -Vascularmintralizitiomni,ld Hemorrhage,oultifocal,mild -Adenocarcinota Nelldifferentiatedu,ctularpattern,areas of moderatemitoticactivity,largeareasof itkrosis,, , -Not examined,not in plantof section -Not examined,missing -Hesatopoiesise,xtrasedullaryi,ncreased, moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bane Narrow,Heart,Stomach,SmallIntestine,Large Intestine, UriniryBladder,Uterus,Ovary,Pituitary,Trachea,Thyroid,LymphNode (sesenteric)P,ancreas, Eye. Animal Number: IR-4634 Sex: Female Group: 1) CONTROL 0 ppe Fite: (Week=105)TerminalSacrifice MicroscopicObservations: Pituitary Hassiry Bland MicroscopicObservations: Adrenal Esophagus Heart - --- --- -- ---- --------- -Mass,0.7 co dia. -Lobularmass,8 x 6 1 4 ce, rightaxilli; lobularmass,9 x 7 x 3.5 ca, left inguinal. -Sinuscidalectasia,cortex,moderate -Not examined,missing -Nyocarditisc,hronicnonsuppurativeg sultifocals,ild - ---------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 91 282 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats ------ --- ----------- - -Anisal Number:IR-4634 Sex: Female Group: Fate: (Weekz105)TerminalSacrifice -- - -- --- 1) CONTROL 0 pps Table:2 MicroscopicObservations(continued): Kidney Liver Lung Mammary gland Parithyroid Pituitary Spleen -Pelvicmineralizationm,inimal -Portalsonanucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hepatocytealterationv,acuclated,sild Hepitocytealteration,basophilic,moderate Hepatocytealteration,eosinophilicm,ild -Vascularmineralizations,ild Perivasculamrnonuclearinfiltratem,ild Hemorrhage,oultifocal,mild -Fibroadenosa Fibroadenama Both masseswere fibroadenosas.Areas of necrosisand cysticareasin tumors. -Not examined,not in planeof section -Adenoma -Hmtopoiesis, extramedullaryi,ncreased, mild Hemosiderosiss,ild Thefollowingtissueswerefoundto be withinnoreillimits: Brain,SpinalCord,BoneNarrow,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder, Aorta,Uterus,Ovary,Trachea,Thyroid,LymphNode (sesenteric)P,ancreas,SalivaryBlind,Eye. -------------------- -------------- ----------- --------- Animal Number: IR-4635 Sex: Female Group: 1) CONTROL 0 ppe Fate: (Weeka 94) FoundDead MacroscopicObservations: SmallIntestine Mammary Bland MicroscopicObservations: Adrenal Esophagus Eye Kidney -Jejunusappearsin4lassedwith reddishfluid; ileumappearsinflaand near cecus. -Mass,7 1 7.5 1 2 cm, oultilabulaarnd ulcerated,rightinguinal;east, lightbeigein color,spherical2, ce dia., in leftaxilla. -Sinusoidaelctasia,cortex,sild Rtmatopciesise,xtrasedullaryc,ortical, moderate -Not examined,missing -Not examined,missing -Chronicprogressivenephropathy,sild Pelvicmineralizationm,inimal Species:Rat ProjectNuabor:OnICM12 Summarized STAR Page: 92 283 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FII-3924T:wo YearOral Toxicity-OncogeniciSttyudyin Rats -- ----------------------------Animal Number: IR-4635 Sex: Female Group: Fate: (Week= 94) FoundDead 1) CONTROL 0 ppe Table:2 MicroscopicObservations(continued): Liver Lung Mammary Gland Parathyroid Pituitary Salivary61and Spleen Thyroid -Hapatocytevacuolationd,iffuse,mild Hmtopciesis, extramedullarsyi,ld Mitoticactivity,increased,moderate -Vascularmineralizationm,ild Metastaticneoplasm -Adenosa Adenocarcinosa Extensivenecrosis. -Notexamined,not in planeof section -Not examined,missing -Not examined,sissing -Hesatopciesise,xtrasidullaryi,ncreased, marked -UltioDbranchiaclyst The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Heart,Stomach,Bull IntestineL,arge Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Trachea,LymphNode (sesenteric)P,ancreas. ------------- ------------- .. ,I -------- Animal Number: IR-4636 Sex: Female Group: 1) CONTROL 0 ppe Fate: tkeeka105)TerminalSacrifice MacroscopicObservations: Mammary Gland Liver MicroscopicObservations: Adrenal Heart Kidney LargeIntestine Liver Lung Mammary Gland Pancreas Parathyroid Pituitary ----------------- - --------- -Hassin rightaxillaappearsto be milkcyst. -Slightlryaiseddark&ass,0.6ca dia.,left laterallobe. -Corticalvacualationf,ocal,mild Sinusoidalectasia,cortex,mild -Myocardiaflibrdsiso,ultifocalm,ild -Chronicprogressivenephropathy,mild -Mematodiasis,colon -Hepatocytveacuclationo,ultifocals,ild Nepitocytealterationv,acuolateds,ild Hepitocytealterationb,asophilics,ild -Vascularmineralizationm,ild Alveolarmacrophages,sild -Lobularhyperplasia -Acinaratrophy,aild -Notexamined,not in plantof section -Adenosa Species:Rat Project Number: 02BICROO12 Suwized STAR Page:93 284 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3q24:Too Year OralToxicity-OncogenicitSytudyin Rats ---------- Animal Number: IR-4636 Sex: Female 6roup: Fate: (Neekz105)TerminalSacrifice 1) CONTROL 0 pps Table:2 MicroscopicObservations(continued): Spleen -Hesosiderasism,ild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Stomach,SmallIntestine,UrinaryBladder,Aorta,Uterus, Ovary,Trachea,Thyroid,Esophagus,LymphNode (sesenteric)S,alivaryGland,Eye. --- ------ --- ---------------- --- --- - ------ AnimalNumber: IR-4637 Sex: Female Broup: 1) CONTROL 0 ppe Fate:(Weekz 82) Sacrificeidn extresis MacroscopicObservations: Pituitary Lung Liver MicroscopicObservations: Eye Kidney Liver Lung Mammary Gland Pituitary Spleen Uterus -Reddened@ass, I ce dia. -Focalareasof consolidatioinn anteriorpart of rightandleftlung. -Possiblypale -Keratitis,acute,marked -Pelvicmineralizitiomni,ld Mineralizatiocno,rticalm,ild Chronicprogressive-paphropathmyi,ld -Nnatocyte vacuolationpgeriportal,moderate -Pneumonia,acute exudative,localareas, moderate Hemorrhageo,ultifacils,ild 4alactDcele -Adenosa -Hemosiderosis,moderate -Cysticglands,moderate The followingtissues*erefoundto be uithinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Ovary,Trachea,Adrenal,Thyroid,Parathyroid,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland. --------------------------- ------------- AnimalNumber: IR-4638 Sex: Female Broup: 1) CONTROL 0 ppe Fate: (Neek=105) TerminalSacrifice MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Esophagus -Mass,0.5 ce dia. -Sinusoidaelctasia,cortex,mild -Not examined,missing Species:Rat Project Number: 0281CROO12 Sumarized STAR Page: 94 285 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year OralToxicity-OncogeniciSttyudyin Rats -----------Animal Number: IR-4639 Sex: Female Group: Fate: (Weekz105) TerminalSacrifice 1) CONTROL 0 ppe Table:2 MicroscopicObservations(continued): Kidney Liver Lung Mammary Gland Parathyraid Pituitary Spleen Uterus -Chronicprogressivenephropithys,ild -Portalbileductproliferatiosni,ld Nepatocytevicuolationo,ultifocal,moderate -Vascularmineralizationm,ild -Not examined,missing -Not examined,not in planeof section -No diagnosis,inadequatesection -Hm siderosiss,ild -Cysticglands,marked The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Trachea,Thyroid,LymphNode (sesenteric)P,ancreas,SalivaryGland, Eye, Oviry. -------------- ------------ - ---- -- ---------------- Animal Number: IR-4639 Sex: Female Group: 1 1) CONTROL0 ppe Fate:(Weeka 56) Sacrificeidn extrimis MacroscopicObservations: Skin Liver MicroscopicObservations: Kidney LargeIntestine Liver Lung NaiisaryBlind SalivaryGland Spleen Uterus -Nidsternalsubcutaneousmass,8 x 8 s 3 ca. -Slightlypale -Pelvicmineralizatiosni,ld Chronicprogressivenephropathys,ild -Nesitodiasisc,olon -Portalaononucleacrellinfiltratem,ild -Hemorrhages,ultifocal,mild -Fibroadenoma -Not examined,missing -Hosasiderosism,ild -Withinnormallimits Fewer thin protocolnumber The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Heart,Stomach,Small Intestine,UrinaryBladder,Aorta,Ovary, Pituitary,Trachea,Adrenal,Thyroid,Parathyroid,Esophagus,LymphNode (sesenteric)P,ancreas, Eye. --------- ----- - ------------------------ Species:Rat ProjectNumber:ONICM12 Summarized STAR Page: 95 286 SummarizSeidnglTeabulatAendimaRleport IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3N FN-3924T:woVeirOralToxicity-NcogeniSctiutdyyinRats --- --- -------AnisalNumber:IR-3697 Sex:Halt Fate:(Weeks94)FoundDead Group: 2) FN-3?24100ppe Table2: MacroscopOibcservations: Skin Spleen Liver MicroscopiOcbservations: Adrenal Aorta Esophagus Kidney Liver Lung LymphNode(nesenteric) Pancreas Parathyraid Pituitary Prostate Salivargyland SmallIntestine SoftTissues(head) Spleen Thyroid Trachea UrinaryBladder -Mass,5 1 4 ce,leftsideof head. -Darkandenlarged. -ftttled -Corticavlacuolatiosni,ld Oneof pairpresent -Notexaminedm,issing -Notexaminedm,issing -Chronipcrogressivne phropathmyi,nimal -Portalocnonucleatrellinfiltratmei,nimal Portalbileductproliferatiomni,nimal Nepatocytveicuolatiodni,ffusem,oderate Negalocytosimsa,rked -Yisculamrineralizatiomni,ld Alvtolamracropbagessi,ld -Mearrhigem,ild -Notexaminedm,issing -Notexaminedm,issing -Notexaminedm,issing -Notexaminedm,issing -Notexaminedm,issing -Withinormallimits Few thanprotoconlumber -Hosingiosartm Largeneoplasimn connectivteissueand musclefromsideof head. Solidareasand largecavernouvsasculasrpaces.Infiltrative intosurroundimnugscle. -Hesatopoiesiesx,trasedullariyn,creased, mild Hemosiderosimsi,ld -Notezaminedm,issing -Notexaminedm,issing -Notexaminedm,issing Thefollowintgissueswe foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,LargeIntestineT,estis/EpididymEiyse,,Heart,Stomach. -- --- -------------- -- -- -- -- SpeciesR:at ProjecNtumber0:281CROO12 SummarizSeTdARPage:96 287 SumarizedSingleTabulatedAn'ul Report(cont'nuld) IndividualNacrmopic and MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-OncognicitSytudyin Rats Table:2 AnimalNumber: IR-3698 Sn: Kale Group: 2) FN-3924 100 ppe Fate: (Neekz 68) FoundDead MacroscopicObservations: Skin Liver UrinaryBladder Prostate MicroscopicObservations: Heart Kidney Liver Lung Prostate Skin UrinaryBladder -Ulceratedfootpads -Possiblyslightlypale and mottled. -Distendedintoabdomenand filledwith reddishfluid. -Slightlyenlargedand thickened. -Nyocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropathy,mild -Portalsonanucleacrellinfiltratem,ild Nepatocytveacuolationo,ultifocils,ild Cystoiddegenerations,ultifocals,ild -Vascularsineralizationm,ild -Prostatitis&,cut@,suppurativem,arked -Podadereatitisu,lcerative,marked -Cystitisa,cute,diffuse,marked The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Done Narrow,Spleen,Stomach,SmallIntestine,Large Intestine,,Awta, Testis/EpididysisP,ituitary,Adrenal,Thyroid,ParathyroidT,rachea,Esophagus, LymphNode (sesenteric)P,ancreas,Salivarygland,Eye. ------------------------- Animal Number: IR-3700 Sex: Kale Group: 2) FN-3924 100 ppe Fate: (Weekz106)TerminalSacrifice MacroscopicObservations: Brain MicroscopicObservations: Adrenal Brain Heart Kidney LargeIntestine Liver -Darkarea,possiblyold hemorrhage,on anteriorrightcerebralhemisphere. -Corticalvacuolationo,ultifocalm,oderate -Astrocytoma,benign Largeneoplasmwith centralcavitation. Numerousgittercellsin cavity. -Myocardiaflibrosiso,ultifocalm,ild -Chronicprogressivenophropithy,mild -Nematodiasisc,olon -Portalsonanucleacrellinfiltrates,ild Portalbileductproliferationm,ild Hepatocytevacoolationo,ultifocal,minimal CystoiddegenerationU,ltifK&I, mild Hep&tKytealterationv,icualatw,mild Negalocytosis,marked Species:Rat Project Number: OHICROO12 BusavizW STU Page:97 288 SummarizedSingleTabulatedAnimilReport (continued) IndividualMicroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3M FM-3924:Too Year Oral Toxicity-OncogenicitSYtudy in Rats Table:2 AnisilNumber:IR-3700 Six:Kale Group: 2) FN-3924 100 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations(continued): Lung Parithyroid Prostate Th,yroid -Vasculirmineralizitiomni,ld Alveolarmacrophages,mild -Not examined,not in planeof section -Prostatitisa,cute,suppurativea,inimal -Cyst,colloid The followingtissueswere foundto be withinnormallimits: SpinalCord,Bone HarroN,Spleen,Stomach,SmallIntestine,UrinaryBladder,Aorti, Testis/EpididysisP,ituitary,Trachea,Esophagus,LymphNode (sesenteric)P,ancreas, SalivarySlind,Eye. ----------------------------------------- - - --------- Animal Number: IR-3701 Sex: hale Group: 2) Ffl-3924100 ppe Fite: (Week=106)TerminalSacrifice MicroscopicObservations: Mammary Gland Adrenal Kidney Liver MicroscopicObservations: Heart Kidney Liver Lung Parithyroid Pituitary Prostate Skin -Subcutaneousmass, 5 1 3 x 5 ca. -Enlarged -Enlarged,paleand pitted. -PaleraisedcircularItsiont'l.t1o dia., median lobe. -Myocardiaflibrosis,focal,mild -Chronicprogressivenephropathy,aarked -Nepatacytevicuolationd,iffuse,moderate Hopatocytealterationv,icuoliteds,ild RegalKytosis,moderate Hyperplistincodule -Yascularmineralizationm,oderate Pneumonia,interstitialc,hronic,oultifocikl, sild Alveolarmacrophages,sild -Hyperplisits,werite -Adencea -Hyperplasiif,ocal,moderate 4ibrosi, subcutaneous Largesolidneoplisewith abundantcollagen fvsation. The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Spleen,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisA,drenal,Thyroid,Trachel,Esophagus, LymphNode (sesenteric)P,a.ncreas,SalivaryBlind,Eye. ------------------------------- -------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 98 289 Sumirized SingleTabulatedAnimalReport(continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3924:Two Year OralToxicity-OncogeniciSttyudyin Rats - - ----------------Animal Number: IR-3702 Sex: Nale Group: Fate: (Week=106)TerminalSacrifice 2) FK-3924 100 ppe Table:2 MacroscopicObservations: Eye Liver MicroscopicObservatims: Adrenal Eye Kidney Liver Lung Pituitary Spleen -Extensiveinflammatioinn righteye post blood sampling. -Mottled -Sinusoidaelctasia,cortex,aild -Panophthalmitisu,nilateral,marked -Chronicprogressivenephropathy,sild -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld Repatocytevacualation,diffuse,moderate Negalocytosis,marked -Vascularsintriilizatisoinl,d Alveolareacrophiges,mild Parivasculamrnonuclearinfiltratea,ild -Cyst,parsdistalis -Hesosiderosism,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Heart,Stomach,W I IntestineL,arge Intestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Thyroid,ParathyroidT,rachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland. ----------------------------------------- -- -- ---- ----------------------------Anisal Number:IR-3703 Sex: Nale Group: 1 2) FN-3924 100 ppe Fate: (Week=79) Sacrificedin extresis MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Pancreas Pituitary - ---- --- ------------- -- -Red mass,I ii ca. -Corticalvacualationf,ocal,minimal Sinusaidalectasia,cortex,minimal -Chronicprogressivenephropithy,mild Pyelonephritisa,cute,moderate -PortalBononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hepatocytveicuolationo,ulti4ocals,ild Negalocytosis,minimal -Vascularsineralizatioani,ld Alveolarmacrophiges,mild Hemorrhage,oultifocal,mild -Acinaratrophy,focal,minimal -mandsa Species:Rat Project Number: 0281CItOO12 Sumarized STAR Page: 99 290 SummarizSeidnglTeabulatAendimaRleport(continued)IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3H FN-3924:Too Year OralToxicity-UncogenicitSytudyin Rats -- --- -- ------------- - --- -- - Animal Number: IR-3703 Sex: Kale Group: 2) FN-3924 100 ppe Fite:(Week=79) Sacrificeidn extrimis Table:2 MicroscopicObservations(continued): Prostate Spleen Stomach Testis/Epididysis Thyroid -Prostatitisa,cute,suppuratives,ild -Hesosiderosiss,ild -Edema, subsucosal,moderate -Tubuleatrophy,asperiatagenesisu,nilateral, minimal -HyperplasiaC,cell,mild Thefollowingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Heart,Small Intestine,LargeIntestine,UrinaryBladder, Aorti,Parathyraid,Trachea,Esophagus,LymphMode (sesenteric)S,alivaryBland,Eye. ---------------- -- ----- --- --- --- ---------- AnisalNumber: IR-3704 Sex: Hale Broup: t 2) FN-3924100 pps Fate: (Week=106)TerminalSacrifice MicroscopicObservations: Vituitary Kidney MicroscopicObservations: Adrenal Heart Kidney Large Intestine Liver Lung P,irathyroid Pituitary Splm Testis/Epididysis -Raisedmass,0.91 0.7ce dia. -Enlargedp,ale,pitted. -Sinusaidaelctasia,cortex,moderate -Myocarditisc,hronicnonsuppuritive, sultifocalm,ild -Chronicprogressivenephropathy,marked -Nesatodiasisc,olon -Portalsononuclearcell infiltrate,mild Portalbile duct proliferations,ild Cystaiddegenerationf,ocal,sild -Vascularmineralizitionm,ild Pneuaonia,interstitialc,hronic,oultifocal, sild -Hyperplisiam,ild -Adenosa -HeRosiderosism,ild -Tubuleatrophy,aspereatogenesisb,ilateral, moderate Polyarteritism,arked The followingtissuesmere foundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Stomach,SmallIntestine,UrinaryBladder,Mwta, Prostate, Thyroid,Trachea,Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. -- ------------ - - -- -- -- - --- SpeciesR:at ProjectNumber:0281CRO12 Wuarized STARPage:100 91 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too Year OralToxicity-OncogenicitSytudyin Rats ---- ------------------------ -- - -- -----AnimalNumber: IR-3705 Sex: Kale Group: 2) FN-3924 100 ppe Fate: (Week=106)TerminalSacrifice Table:2 MacroscopicObservations: Resentery MicroscopicObservations: Adrenal Kidney Liver Lung Nesentery Parithyroid Salivary61and Thyroid Trachea -Bloodycysticlesion,4 1 3 ce dia.,possibly tumor or hesatosa. -Corticalvacuolationi,ocal,moderate Sinusoidalectasia,cortex,moderate Nodularhyperplasiac,ortex,focal,moderate -Chronicprogressiventphropithym,ild -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hepitocytaelterationv,acuolateds,ild Regalocytosis,moderate Hyperplasticnodule -Yascularmineralizations,ild -Cyst Grosslesionwas largecysticstructurewith many hoonsiderinladen macrophagesand sononuclearinflammatorcyellswithinthe wall. -Not examined,missing -Not examined,missing -Not examined,missing -No diagnosis,inadequatesection The followingtissueswere foundto be withinnormallimits: Brain,SpinilCord,BoneKarroo,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididymiPsr,ostate,Pituitary,Esophagus, LymphNode (sesenteric)P,ancreas,Eye. -- ----------------------------- -- -- ---------------------------------------Animal Number: IR-3706 Sex:Nile Group: 2) Ffl-3921400 ppe Fite: (Neeka106)TerminalSacrifice MacroscopicObservations: Liver MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver ----------------------------- -- -Slightlypale -Corticavlicuolationo,ultifocals,ild -Not examined,missing -Myocarditisc,hronicnonsuppurative, oultifocalm,inimal -Chronicprogressivenephropathy,marked -Portalsonanucleacrellinfiltratem,ild Nepatocytevatuolation,centrilobularm,arked Cystoiddegeneration,UltifKal, mild Negalocytosis,marked Species:Rat Project Number: 0281CROO12 SummarizedSTAR Page: idt 292 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-OntogeniciSttyudyin Rats Table:2 AnimalNumber: IR-3706 Sex: Male Group: ( 2) FN-3724100 ppe Fate: (Neekz106)TerminalSacrifice MicroscopicObservations(continued): Lung Pancreas Pituitary -Yascularmineralizationm,ild -Not examined,missing -Cyst,parsdistalis The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,DoneNarrow,Spleen,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Thyroid,ParathyraidT,rachea, LyaphNode (sesenteric)S,alivaryGland,Eye. ----------------------------------------- Animal Number: IR-3707 Sex: Male Broup: 2) W3924 100 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Liver MicroscopicObservations: Kidney Liver Lung LymphNode (sesenterit) Parathyroid Spleen -Scatteredpale foci and pink raisedmass,I ce dii.,in leftlateralobe. -Chronicprogressivenephropathy,minimal -Portalmanonacleacrellinfiltratem,ild Portalbileductproliferationm,ild Hepatocytevacuolation,oultifocal,moderate Cystoiddegenerationf,ocal,minimal Nepatocytealteration,vacuolated,moderate flegalocytosism,arked "rplastic nodule -Yascularmineralizationm,ild Alveolareacrophages,mild Hemorrhage,focal,sild -Hemorrhage,moderate -Notexamined,not in planeof section -Hetosiderosis,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Trachea, Esophagus,Pancreas,Salivary Gland, Eye. ------------------------ ----------------- --- ------------- --- ------------------- Species:Rat hoject Number: 0291CROO12 Summarized STAR Page: 102 293 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too Year OralToxicity-OncogeniciSttyudyin Rats -------------------------------------AnisilNumber:IR-3708 Sex: Nale Group: Fate: (Weeks100)Sacrificedin extreais - --------2) Ffl-3924100 ppe Table:2 MacroscopicObservations: Lung MicroscopicObservations: Adrenal Esophagus Eye Heart Kidney Liver Lung Lymph Mode (sesenteric) SalivaryBland Spleen -Leftlobe completelyconsolidatedp;artial consolidatioonf rightlung. -Corticalvacualitionl,ocalareas,mild Nodularhyperplasiac,ortex,focal,sild -Mt examined,missing -malignantlymphosa,histiocytic -Myocarditisc,hronicnonsuppurative, oultifocalm,ild malignantlymphoma,histiocytic -Chronicprogressivenephropathy,mild -Portalbileductproliferationm,ild NePatocytevacuolationo,ulti4ocals,ild flegalocytosimsi,ld -Vascularmineralizatiosni,ld Hemorrhage,oultifocil,mild Malignantlymphosa,histiocytic Brossappearanceof consolidationdue to massiveinfittrition-'0n4e"lastic histikytictype lymphocytes. -Not examined,missing -Malignantlyaphona,histiocytic -Hemosiderosiss,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard, Bone Narrow,Stomach,BeallIntestineL,arge Intestine,UrinaryBladder, Aorta,Testis/EpididyeiPsr,ostate,Pituitary,Thyroid,ParathyraidT,rachea,Pancreas. ---------------------- - -------------------------------- Animal Number: IR-3709 Sex:Halt Group: 2) FN-3924 100 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Liver MicroscopicObservations: Adrenal Kidney Liver --- -- -Scatteredyellowishfoci. -Nodularhyperplasia,cortex -Chronicprogressivenephropathy,mild -Portalsonanucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld Nepatocytevacuclationd,iffuse,moderate Regalocytosism,ild Hepatacytaelterationb,asohilic,mild ------------- ---------------- Species:Rat Project Number: 0281CROO12 SummarizedSTAR Page: 107 294 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-UncogeniciSttyudyin Rats ---------- -- --------- --- --- --- --- Animal Number: IR-3709 Sex:Hilt Sroup: Fate: (Week=106)TerminalSacrifice 2) R-3924 100 ppe Table:2 MicroscopicObservations(continued): Lung Parathyroid -Vascularmineralizationm,ild Perivasculasrmonuclearinfiltratem,ild -Notexamined,not in planeof section The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,DoneMarro*,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ------------------------------ ---- - ----------------- Animal Number: IR-3710 Sex: Hale group: 2) W3924 100 pps Fate: (Week=106)TerminalSacrifice MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Pituitary Thyroid -Raisedmass,0.9 cg dia. -Corticalvacuclationi,ocal,moderate -Chronicprogressivenephropathy,mild -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hopatocytveicuolationo,ultifocalm,ild Nepatocytealterationv,icuolateds,ild Regalocytosiss,ild -Vascularmineralizations,ild Alveolarascrophages,mild Perivasculamranonuclearinfiltratem,ild -Adenoma -HyperplasiaC,cell,sild Ultisabranchiaclyst The followingtissues*ere found.tobe withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Parathyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. -- -- - ------------------------ ----------------- --- - ------------------------- Animal Number: IR-3712 Sex: Hale Broup: 2) FN-3924 100 pps Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Liver MicroscopicObservations: Adrenal - ----------------- -- -Appearsenlargedand sattled. -CorticalVaEgOlitiOn@,UltifKallsild Modularhyperplasiac,ortex,fK&I, mild Species:Rat Project Number: 0291CROO12 &mwized STAR Page: 104 295 SummarizedSingleTabulatedAnimalReport (continued) I.RdividuaNlacroscapicand NicroscapicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral 7axicity-OncogeniciSttyudyin Rats - - -------AAisal Number:IR-3712 Six: Nale group: 2) FN-3924100 ppe Fate: (Week=106)TerminalSacrifice Table:2 MicroscopicObservations(continued): Kidney LargeIntestine Liver Lung Pancreas Parathyroid Spleen -Chronicprogressivenephropathy,mild -Netatodiasisc,olon -Hepatocytevacuolation,diffuse,moderate Cystoiddegenerationf,ocal,minimal Negalocytosis,marked -Vascularmineralizationm,ild Alveolarmacrophages,sild -Acinaratrophy,sild -Notexamined,not in planeof section -Hnosiderasiss,ild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,One Narrow,Heart,Stomach,SmallIntestine,UrinaryBladder,Aorta, Testis/EpididysiPsr,ostate,Pituitary,Thyroid,Trachea,Esophagus,LymphNode (sesenteric), SalivaryGland,Eye. ------------------------------ - ----------- --- -------- Animal Number: IR-3713 Sex: Male Group: 2) FN-3924 100 ppe Fate: (Weeks106)TerminalSacrifice NacroscopicObservations: Adrenal NicroscapicObservations: Adrenal Kidney Liver Lung Pancreas Parathyroid -Enlargedinvolvinghemorrhagicmass 2 1 1 ce dia. -Sinusoidalectasia,cortex,mild Nedullarycell hyperplasiau,nilateral, marked Hemorrhage,unilateral,marked grosslyabnormaladrenalcompletelyreplaced by encapsulatedareaof organizing hemorrhage. -Chronicprogressivenephropathy,sild -Nepitacytveicuolationd,iffuse,moderate Cystoiddegenerationf,ocal,sild Reg&IKYtDSig, moderate -Vascularmineralizatiosni,ld Alveolareacrophages,mild -kinar atrophy,sild Hyperplasiai,sletcell,moderate -Not examined,not in planeof section The 4ollowingtissueswe foundto be withinnormallimits: Brain,SpinalCord,Bone lurrov,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 105 296 Sunarized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3M FN-3924:Two Year Oral Toxicity-OncoginicitSytudy in Rats -- -- -----------Animal Number: IR-3713 Six: Kale Fate: (Week=106) TerminalSacrifice Broup: ( 2) FN-3924100 ppe Table: 2 MicroscopicObservations(continued): The followingtissueswerefound to be withinnormallimits (continued): UrinaryBladder,Aorta, Testis/EpididysisP,rostate,Pituitary,Thyroid,Trachea,Esophagus, Lymph Mode (sesenteric),SalivaryGland, Eye. ----------------------------------- - ----- --- ------- Anisal Number: IR-3716 SeK: Mile Group: Fite: (Week= 83) Sacrificedin extresis 2) Ffl-3924100 ppe MacroscopicObservations: Liver Skin Microscopic Observations: Adrenal Brain Kidney Liver Lung Pancreas Soft Tissues(head) Stomach Testis/Epididysis Thyroid -Pale -Ulcerated&ass, 5 x 4 1 3 ce, containing large areas of necrosisinvolving subcutaneousand muscle tissue in ire&, possiblytumor or chronicabscess. -Sinusaidalectasia,cortex,mild Nodularhyperplasii,cortex,focal,minimal -Metastaticneoplasm Multiplesmalltaboliof Zyabalgland carcinoma in meningealvessels. -Chronicprogressivenephropithy,sild -Portalbile duct proliferationm,inimal Repatocytevacuolation,diffuse, marked Regalocytosis,moderate -Yascularmineralizationm,ild Alveolar eacrophages,mild Perivasculasronanucleirinfiltrate,mild -kinir atrophy,moderate -Zyobal gland carcinoma Largeneoplasm,infiltrative,with extensive necrosis. Squisoussetaplasii,Originfro& Zyabal gland clearlyevident. -Edema, subsucosal, moderate -Yascularmineralizationf,ocal,minimal Leydigcell hyperplasia,focal,minimal -Cyst,colloid The followingtissueswere foundto be withinnormallimits: SpinalCard, Bme Marro*,Spleen,Heart,Small Intestine,Large Intestine,Urinary Bladder, Aorta,Prostate,Pituitary,Parathyroid,Trachea,Esophagus,Lymph Node (sesenteric), SalivarySlind,Eye. - -- --- -- --- --- ---------------- ---------------- ------------------------ Species: Rat Project Number: 0281CROO12 ;6 Summarized STU Page: 297 Sumarized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3124:Two Year Oral Toxicity-WcoginicitSytudyin Ratt ----------------------- ------------------Animal Number: IR-3717 Six: Hale Group: 2) FN-3924100 pps Fate: (Week-1-06)TerminalSacrifice Table:2 MacroscopicObservations: Pituitary MicroscopicObservations: Kidney Liver Lung Pituitary Spleen Testis/Epididysis Thyroid -Raisedmiss,0.5 ce dia. -Chronicprogressivenophropathy,sild -Portalmanonucleacrellinfiltratea,ild Portalbileductproliferationm,ild N"alocytosis,mild -Vascularmineralizationm,ild Alveolarmacrophiges,mild -Adenoaa -Hemosiderosism,ild -Mineralizatiotnu,bular,sild -HyperplasiaC,cell,mild The followingtissueswere foundto be withinnormallimits: Brain,SpinilCard,Bone Narrow,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Prostate,Adrenal,Parithyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. - -- --- -- --- -------- Anisal Number: IR-3718 Sex: Hale Group: 2) W3924 100 ppo Fite: (Veekz106)TerminalSacrifice MacroscopicObservations: Pituitary Liver MicroscopicObservations: Kidney Liver Lung Pancreas Pituitary Thyroid -Hemorrhagilcesion,0.3 co dia. -Mottled -Chronicprogressivenephropathy,minimal -Portaloononucleacrellinfiltrates,ild Nepatacytevicuolation,diffuse,moderate Negalocytosis,marked Hepatocytealteration,basophilic,moderate -Vascularmineralizations,ild Pneumonia,interstitialc,hronic,focal, minimal -Isletcell adenaga -Adenama -Falliculahryperplasiac,ystic,unilateral, sild The followingtissues#ere foundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBlidder,Aorta,Testis/EpididysisP,rostate,Adrenal,ParithyroidT,rachea,Esophagus, LyaphNode (sesenteric)S,alivaryBland,Eye. -- ---------- ----------------- - ---------------------- -- ------- Species:Rit Project Number: 0281CROO12 Summarized STAR Page: 107 298 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:-TwoYear Oral Toxicity-OncogenicitSytudy in Rats Table:2 ----------------------------------- --- ---------------------------------- -- -- --- Animal Nuaber: IR-3719 Sex: Malt Group: 2) Ffl-3924100 pps Fate:(Week= 62)Sacrificedin extresis MicroscopicObservations: Skin Liver Abdomen(internal) Kidney MicroscopicObservations: Kidney Liver Lung Skin Spleen Thyroid -Largesubcutaneoumsiss in ventralcervical area,5 1 6 t 6 ce;multiplecysts containingdark red fluidwithinmass. -Slightlpyall -Stomachand smallintestinegas filled. -Roughsurfacewith patchypale areas. -Pigment,conv.tub. epithelium,moderate Kephrosis,tubular,moderate -HtpatKYte VaCUOlatiOn,UltifK&I,mild Necrosis,focal,mild Hesatopciesite,xtramedullaryw,ild -Yasculimrinerilizatiosni,ld Hemorrhage,local areas,moderate Metastaticneoplasm -Fibrosarcoma,subcutaneous Will differentiatendeoplasmwith moderate callagenformation.Largeareasof necrosis. -Heastopoiesise,xtramedullaryi,ncreased, marked -Ultimabranchiaclyst The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,ParithyraidT,rachea, Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. -------------------------------------------------------------------------------------- Animal Number: IR-3723 Sex: Male Group: 1 2) FM-3924 100ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Liver -Enlargedwith scatteredpale foci. MicroscopicObservations: Adrenal Kidney Liver ------ ------------------ -Corticavlicuolationf,ocal,wild -Chronicprogressivenephropathy,wild -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hepatocytevacuolation,oultifocal,moderate Hepatocytealterationv,acuolated,mild Regalacytosis,marked Species:Rat Project Number: 02BICROO12 Summarized STAR Page: 106 299 SummarizedSingleTabulatedAnimalReport ftontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral 7axicity-OncogeniciSttyudyin Rats - --- - ------------------------------- Animal Number: IR-3723 Six:Halt Group: ( 2) FN-3924100 ppe Fate: (Weeks106)TerminalSacrifice Table:2 MicroscopicObservations(continued): Lung Spleen Trachea -Vascularmineralizationa,ild -Hemosiderosism,ild -Tracheitisc,hronic,sild The follovingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/Epididy2iPsr,ostate,Pituitary,Thyroid,ParathyraidE,sophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ----------------------------------------------------------------------------------- Animal Number: IR-3724 Sex: Nale Group: 1 2) FM-3924 100 ppe Fite:tweekz B2)Sacrificeidn extresis MicroscopicObservations: Skin Lung Spleen Abdomen(internal) Kidney Liver MicroscopicObservations: Aorta Bone Heart Kidney Liver -Large,subcutaneousmass,7 x 6 x 5 ca, in left inguinalarea;completely surroundinglefthindlimb. Massveryfirs,hardand grittyuponcutting, boney in appearance. -Raised,whitish,circularmass,0.6ca dii., leftlobe;raisedcircularlesion, 0.3ce dia.,in rightdiaphragmatilcobe. -Enlirged -Hard,boney,oultilobulamrass,2.5 x 2 x 2 ce, in omentat. -Hydronephrosisl,eft -Smallwhitishlesion,0.2 ce dia.,median lobe;smillpileyellowishlesion, 0.4ce dia.,leftlaterallobe. -Not examined,missing -Osteosarcotah,indleg Largeneoplasmwith abundantnew ostecidand bone formation. -Myocardiaflibrosis,focal,sild -Chronicprogressivenephropathy,aild Hydronephrosisu,nilateral,moderate Nephrosis,tubular,moderate -Nepatacytveacuolationc,antrilobular, moderate Regalocytosism,ild Malignantlyaphosa,lyaphocytic Two grosslydescribednodulescomposedof largelyaphoblasticcellswithmiculir nucleiandhighmitoticactivity.Different fro*osteosarcomacells. - ------ -- ------ ----------------- Species:Rit Project Number: 0281CROO12 Summarized STAR Page: 109 300 SummarizedSingleTabulatedAnisilReport (continued) .IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FK-3q24:Too Year OralToxicity-OneogenicitSytudyin Rats ---------------- ---------------- ------------------ - ----------AnisilNumber:IR-3724 Sex: Mile Group: 2) FM-3924100 ppe Fate:(Week= 82) Sacrificedin extreais Table:2 MicroscopicObservations(continued): Lung Par,ithyroid Spleen Thyroid -Yiscularmineralizationm,ild Hemorrhage,local areas, moderate Metastaticneoplasm Multiplewtistasesof osteosarcoaa throughoutlung. -Hyperplasita,ild -Nesatopoiesise,xtramedullaryi,ncreased, sild -C cell adenosa The followingtissueswere foundto be withinnormallimits: Brain,SpinilCard,Bone Narrow,Stomach,SmallIntestine,Large Intestine,UrinaryBladder, Testis/EpididysisP,rostate,Pituitary,Adrenal,Trachea,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryGland,Eye. ---------------------------- - -- --- ---------- ---------- --- -------------------------Ania,ilNumber: IR-3725 Sex: Hale Group: 2) FK-3924 100 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations: Eye Done MicroscopicObservations: Bone Eye Heart Kidney Liver Lung Parathyroid -Extensiveinflammatioonf righteye afer blood sampling. -Leftrtirmetatarsajlointswollen. -Arthritiss,ynovitisj;oints,hindleg, moderate -Panophthalsitiusn,ilateral,marked -Myocarditisc,hronicnonsuppurative, oultifocilm,ild -Chronicprogressivenephropathy,minimal -Portalmanonucleacrellinfiltrates,ild Portilbileductproliferatiosni,ld Hepatocytevicuolationo,ultifocalm,ild Cystoiddegenerationf,ocal,sild Regalocytosis,moderate -Vascularmineralizationm,inimal Alveolaraacrophages,sild Fewer thin protocolnumber -Notexamined,not in planeof section The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Trachea, - -------------------------- Species:Rat Project Number: 0281CROO12 SummarizedSTAR Page: tio 301 SumairizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rits Table:2 AnisilNumber:IR-3725 Sex: Kale Group: ( 2) FN-3924100 pps Fate: (Weeiz106)TerminalSacrifice MicroscopicObservations(continued): The followingtissueswerefoundto be withinnormallimits(continued): Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryGland. ------------------------------- --- --- ------ - --------------- ------ Animal Number: IR-3726 Sex: Male Group: 2) FN-3124 100 ppo Fate: (Weekz106)TerminalSacrifice MicroscopicObservations: Pituitary Liver Microscopic Observations: Adrenal Esophagus Kidney Liver Lung Pituitary Spleen Testis/Epididysis -Raisedhemorrhagiclesion,0.4 co dia. -Stallscatterepdale foci. -Sinusaidaelctisia,cortex,sinisil -Not examined,missing -Chronicprogressivenephropathy,mild -Portalsononucleacrellinfiltrates,ild Hepitocytveacuolationo,ultifocals,ild H"atocyte alterationv,acuolited,moderate Negalacytosis,moderate -Vascularmineralizations,ild Hewrhagt, oulti4ecalt,ild Adenosa Smallpapillaryneoplasmnear hilus. Well differentiated. -Adenosa -Neeasiderosism,ild -Vascularsineralizationm,inimal The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Marro*,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Prostate,Thyroid,ParithyraidT,rachea,LymphNode (sesenteric), Pancreas,SalivaryGland,Eye. ------------------------------------------------------------------------------------------ Animal Number: IR-'j728 Sex: Halt Group: 2) FN-3924 100 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Liver MicroscopicObservations: Adrenal --------------- ------ -Paleraisedmass, 1.31 0.8 ca, anterior rightlaterallobe. -Corticalvacoolationl,ocalareas,moderate Nodularhyperplisiac,ortex,lUltifK&I, moderate Medullarycellhyperplasiaf,ocal,sild ------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 111 302 SummarizedSingleTabulatedAnimalReport lcontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3q24:Two Year OralToxicity-OncogenicitSytudyin Rats -- ------------------- -- ------------Animal Number: IR-3728 Sex: Kale Group: 2) FN-3q24100 ppe Fate: (Week=106)TerminalSacrifice Table:2 MicroscopicObservations(continued): Kidney Liver Lung Pancreas .Pituitary Spleen Thyroid -Chronicprogressivenephropathy,moderate -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiotni,ld Nepatacytevacuclationc,entrilabular, moderate Cystaiddegenerationf,ocal,mild Regalacytosis,moderate Hyperplasticnodule Largelesionwith goodpreservationof lobulu structure.Hostcellsof nodule vacuolated. -Yascularmineralizations,ild Hemorrhage,diffuse,moderate Fewer than protocol number -Acinaratrophy,moderate -Not examined,missing -Hemosiderosism,ild -Folliculahryperplasiac,ystic,unilateral, marked The followingtissuesverefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,ParathyroidT,rachea,Esophagus, LymphMode (sesenteric)S,alivaryGland,Eye. ---------------------------------------------------------------------------------------- Animal Number: IR-372q Sex: Nale Group: 2) W3q24 100 ppe Fate:(Week= 64)Sacrificedin extresis MacroscopicObservations: -No visiblelesions. MicroscopicObservations: Kidney Liver -Chronicprogressivenephropithy,minimal -Portalsonanucleacrellinfiltratem,ild Nepatacytevacuclationo,ultifdcal,mild Necrosis,oultifocals,ild Negalocytosis,marked Pigment,portal,mild Lung -Yascularmineralizations,ild Hemorrhage,localireas,mild Parathyroid -Not examined,not in planeof Section Spleen -Hesasiderosism,ild -- --- --------------------------- --------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 112 303 Sunarized SingleTabulatedAnimalReportlcontinued) IndividualMacroscopicand MicroscopicObwvitions RikerLaboratoriesI,nc. 3H FN-3924:Too Year DrilToxicity-OncogeniciSttyudy in Rats --- --- - -- -- --- ---- - Animal Number: IR-3729 Sex: Mile Group:( 2) FN-3924100 ppe Fate:(leek=64) Sacrificeidn extresis Table:2 MicroscopicObservations(continued): Testis/Epididysis -Vascularsineralizationm,ild The followingtissues*erefoundto be withinnormallimits: Brain,SpinalCard,Bane Narrow,Heart,Stoaach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Prostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. -------------------------------------- ------------- An;saalNumber: IR-3730 Sex: male Group: 1 2) FM-3924 100 ppe Fite: (Week=106)TerminalSacrifice MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung LymphNode (sesenteric) Pancreas Pituitary Spleen -Raisedmass,0.6 cm dia. -Corticavlicualationf,ocal,sild Sinusoidalectasia,cortex,minimal -Chronicprogressivenephropathy,moderate -Portalbileductproliferatiosni,ld Hepatocytovacuolatidno,ulti4ocal,mild Negalocytosiss,ild Pigment,parenchymal,minimal -Vascularsineralizatiosni,ld -Pigment,aild -Not examined,missing -Adencoa -Hemosidernsiss,ild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Thyroid,Parathyri)iTdr,achea,Esophagus, SalivaryGland,Eye. --------------------------------- --- --------------- ---------------------------AnimalNumber: IR-3731 Sex: Nile Group:( 2) FN-3924100 ppe Fate:(Veekx106)Sacrificedin extresis MacroscopicObservations: Small Intestine Stomach MicroscopicObservations: Adrenal ------ ---------- - -- --- -- -Sphericalmass,dark,0.5 ce dia.,near beginningof jejunue,attachedto outsidewall. -Enlargedgastricrugatwitherosions. -Sinusaidal-actascioar,tex,owtifocal,sild --- ---- --- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 113 304 SumarizSeidnglTeabul&tAWnimaRlepor(tcontinued) IndividuRaalcmr opicandMicroscopOibwc vations RikerLaboratoriesI,nc. 3N ' FN-3924:Too YearOral Toxicity-hcogtnicitSytudyis Rats Table,.2 AnimalNumber: IR-3731 Sax:Halt Group: 2) Fil-3924100 ppe Fate:(Week=106)Sacrificedin extruis MicroscopicObservations(continued): Kidney Liver Lung Pancreas P,irathyroid Spleen Stomach Thyroid -Calculus,pelvic -&PAtKYtt VACUDI&tiOn@,UltifKal,mild Cystaiddegomwition,Witi4K&I, sild %OAIKYtOSig, moderate -Vascularaintr&lizationm,ild Howrhale,UltifKal,sild -Islettelladenna Encapsulatedw,elldifferentiatetduw (Brosslesion.) -Notexamined,not in planeof section -Hm siderosiss,ild -Necrosis,secoul, moderate -HyperplasiaC,call,sild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,SmallIntestine,Large Intestine,tiritiaSrlyadder, Aorta,Testis/EpididysiPsr,ostate,Pituitary,trachea,Esophagus,LymphNwe (wsenteric), SalivaryGland,Eye. - - ------------- ------ - -- - --- -- AnimalNumber: IR-3734 Sex:Halt Group: 2) FN-3924 100 ppe Fate: (Meek= 45) FoundDead MacroscopicObservations:0Kidney Spleen UrinaryBladder MicroscopicObservations: Adrenal Eye Kidney LargeIntestine Liver Lung Lymph Mode(mmteric) Pancreas PreputiilBlind SalivaryGland SmallIntestine -Bilateralmarkedhydronsphrosis. -Appearssaallw -Expandedwith hard calculimeasuringabout 0.8 co dia. -Sinusoidaelctasia,cortex,focal,sild -Mt examined,missing -Pyelonephritisa,cute,moderate Hydronephrosisb,ilateral,moderate -Not examined,missing -%Wlocytosis,sild -Vascularsintralizatiomni,ld Alveolarucrophages,sild -Not examined,missing -Not examined,missing -hepatialikdonititK,uteo marked -M flaminwo missing -Not examined,missing "Otcomi0ic GGJ&ItV)077*PJS: Halot- w&rah^m ~Irao JO&AIAIC04L. A*&* , AAJP hoo"mo 'WOUTP# - OqCWAfi$.q IAICA&CW_ ; '0~ 01-*3.S o@g srumy Species:Rat ProjectNumber:ONICROO12 I- IAIGW-&IAAJ7JPi@L a C. clome--m* .4,bLE WnarizW STARPage:114 V*A) AM.404 305 Smarized SingleTabulatedAnimalReport(continued) .IndividuaMlacroscopicand MicroscopicObwvations RikerLaboratoriesI,nc. 3H FN-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3734 Sex: Kale Fate: (Week= 45) FoundDead Group: 2) FN-3924 100 ppe MicroscopicObservations(continued): Spleen UrinaryBladder -Nmosidorosis,moderate Atrophy,moderate -Epitheliahlyperplasiap,apillaryd,iffuse, marked The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Done Narrow,Heart,Stomach,Aorta,Testis/EpididysiPsr,ostate,Pituitary, Thyroid,Parathyroid,Trachea,Esophagus. ----------------------------- ------- - -------------------- Animal Number: IR-3735 Sex:Halt Group: 2) FN-3924 100ppe Fite: (Weeks 52) FoundDead MacroscopicObservations: MicroscopicObservations: Eye Kidney LargeIntestine Liver Lung Lymph Node (sesenteric) Parathyroid SmallIntestine Testis/Epididymis -No visiblelesions. -Not examined,missing -Mineralizatiotnu,bular,mild -Not examined,missing -Necrosis,centrilobularm,arked -Vascularmineralizations,ild -Not examined,missing -Not examined,not in planeof section -Not examined,missing -Vascularmineralizationm,inimal The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,UrinaryBladder,Aorta,Prostate, Pituitary,Adrenal,Thyroid,Trachea,Esophagus,Pancreas,SalivaryGland. - -- -- -- ------------------- Animal Number: IR-3738 Sex: Kale Group: 2) FN-3924 100 ppe Fate: (Week=10t)TerminalSacrifice MicroscopicObservations: Thyroid Pituitary Liver -Possiblyslightlyenlarged. -Hemorrhagiclesion,0.4 ce dia. -Scatteredpalefoci. MicroscopicObservations: Adrenal -Sinusoidalectasia,cortex,minimal Nodularhyperplasiac,ortex,focal,minimal Heart -Nyocarditisc,hronicnonsuppurative, oultifocalm,ild - - ---- -- ---- - - ------------------------------------ Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 115 306 Suuarized SingleTabulatedAnimalReport(continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year OralToxicity-OncogeniciSttyudy in Rats Table:2 Animal Number: IR-3738 Sex: Male Group: 2) FN-3924100 pps Fate: (Week=106)TerminalSacrifice MicroscopicObservationslcontinued): Kidney Liver Lung Parathyroid Pituitary Thyroid Trachea -Chronicprogressivenephropithy,minimal Pyelonephritisa,cute,sild -Repatocytovacualationo,ultifocal,mild Cystoiddegenerationo,ultifocal,mild Repatocytealteration,vacualated,moderate NepatKyte alterationb,asophilic,moderate Negalocytosiss,ild -Vascularsineralizationm,ild Alveolareacrophages,mild -Not examined,missing -Adenoma -Not examined,missing -Cyst,subepithelial The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Esophagus,LymphKade lsesenteric), Pancreas,SalivaryGland,Eye. ------------------------- -------- - ---------------- Animal Number: IR-3739 Sex:Halt Group: 2) FN-3924100 pps Fate: (Week=106)TerminalSacrifice MicroscopicObservations: Pituitary Liver Adrenal MicroscopicObservations: Adrenal Heart Kidney Liver ------------- ---- -Raisedmass,0.5 ce dia. -Scatteredpale foci. -Rightadrenalgreatlyenlargeddue to 2 ce dia. &ass. -Atrophy,cortical,marked Carcinoma,cortical,unilateral Large,welldifferentiatehdi,ghmitotic activity,extensivenecrosis.Harked secondaryatrophyof cortexin contralateral gland. Multipletetastases. -Myocardiaflibrosis,localareas,sild Myocarditis,chronicnonsuppurative, localareas,mild -Chronicprogressivenephropathy,marked -Portalbileductproliferatiosni,ld Hepatacytvoacualationo,ultifocals,ild Regalocytosism,ild Metastaticneoplasm --- - ---- --------- Species:Rat Project Number: 0291CROO12 Susurized STAR Page: 116 307 Sumarized SingleTabulatedAnimalimport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3739 Sex: Nale Group: 2) FN-3924 100pps Fate: (Weekz106)TerminalSacrifice MicroscopicObservations(continued): Lung Parathyraid Pituitary Spleen -Vascularsinerilizatiomni,ld Alveolarmacrophiges,mild netistaticneoplasm Hemorrhage,local areas, moderate -Mt examined,not in planeof section -Adenota MetastaticnEDPIaSl -Hesasiderosiss,ild The followingtissuesmerefoundto be withinnormallimits: Brain,SpinilCord,Bone Narrow,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder, Aorta,Testis/EpididysisP,rostate,Thyroid,Trachea,Esophagus,LymphNode (sesenteric), Pincreis,SalivaryGland,Eye. ----------------------------------------------------- -- --- -- --------------------Animal Number: IR-3740 Sex: Nale Group: 2) FN-3924 100 pps Fite: (Weekr106)TerminalSacrifice MicroscopicObservations: MicroscopicObservations: Kidney Liver Lung Trachea -No visiblelesions. -Chronicprogressivenephropathy,sild Pyelonephritisa,cute,moderate -PortalBononucleacrellinfiltratem,ild Portilbileductproliferatiosni,ld Negalacytosis,moderate -Vascularmineralizitiosni,ld Pneumoniai,nterstitialc,hronic,focal,sild -Cyst,subepithelial The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Splm, Heart,Stomach,SaillIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parathyraid, Esophagus,Lymph Node (sesenterici,Pancreas,SalivaryGland,Eye. --- ------ -------- ---- ---- ---------------------- --- - Animal Number: IR-3741 SeK: R&II Broup: ( 2) FN-3924100ppe Fate: (Veekz106) TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal -No visiblelesions. --- - -Corticavlicualitionf,ocal,minimal Sinuscidalectasia,cortex,mild -------------- --- ---------- Species:Rat Project Number: 0201CROO12 Summarized STAR Page: 117 308 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:TtiiYearOral Toxicity-OncoginiciSttyudyin Rats Table:2 Animal Number: IR-3741 Sex: Nale Group: 2) FN-3q24 100 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations(continued): Kidney Liver Lung LymphKade (sesenteric) Pancreas Parithyraid Pituitary Trachea -Chronicprogressivenephropathy,minimal -Nepitocytveacuolationo,ultifocals,ild "locytosis,mild -Yascularmineralizations,ild Perivisculamranonucleairnfiltrates,ild -Hemorrhage,minimal -Acinaratrophy,sild -Not examined,not in planeof section -Adenosa -Cyst,subepithelial The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Thyroid,Esophagus,SalivaryBland,Eye. --------------- - - - --------------- - -- -- -- Animal Number: IR-3742 Sex: Halt Group: 2) FN-3924 100ppe Fate:(Neekz 77) Sacrificeidn extresis MacroscopicObservations: Skin Liver MicroscopicObservations: Kidney Liver Lung LymphNode (sesenteric) Skin -Healingulcerationan leftrearfootpad. -Appears somewhatpale and wttled; possible areaof infarctioinn rightlateral lobe. -Chronicprogressivenephropathy,minimal Hyperplasiap,elvicepithelium,localareas, sild -Hepatocytevacualation,diffuse,marked Necrosis,diffuse,marked Necrosis,contrilabulars,ild Regalocytosis,moderate -Yascularmineralizations,ild Alveolareacrophagess,ild Hemorrhage,localareas,sild -Not examined,missing -Pododermatitisu,lcerativeh,indleg,marked The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bwe Narrow,Spleen,Heart,Stomach,Small IntestineL,arge Intestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,Pancreas,SalivaryBland, Eye. - - -------- -- ------------------------------- Species:Rat ProjectNumber:OnICM12 SummarizedSTAR Page: its 309 SummarizedSingleTabulatedAnimalReport (continutd) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Tvo Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Anisal Number: IR-3743 Sex: Kale Group: 2) Ffl-3924100 ppe Fate:(Weeks95) Sacrificedin extresis MacroscopicObservations: Pituitary Liver Testis/Epididysis MicroscopicObservations: Adrenal Kidney Liver Lung Lymph Node (sesenteric) Pituitary Prostate Spleen Testis/Epididysis -Raiseddark mass,I ce dia. -Paloand attled. -Appearstill -Corticavlacuclationo,ultifocalm,ild Nodularhyperplasiac,ortex,oultifocalm,ild Atrophy,cortical,mild -Chronicprogressivenephropathy,mild -Portalbileductproliferatiomni,ld NepatDcytevacualation,periportal,moderate -Vascularsineralizatiosni,ld -Not examined,missing -Adenosa -Not examined,missing -Hmsiderosis,mild -Tubuleatrophy,isper&tDgenesisb,ilateral, marked The follamingtissuesverefoundto be vithinnormallimits: Brain,SpinalCard,BoneMarrov,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta, Thyroid,Parathyraid,Trachoa,Esophagus,Pancreas,SalivaryGland,Eye. ------------------------------ -- AnimalNumber: IR-3744 Sex: Hale Group: 2) FN-3924 100 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Skin Pituitary Liver MicroscopicObservations: Adrenal Heart Kidney Liver Lung ----------------- --- ----- -Raisedulceratedinflassedlesionon right hind footpad. -Small,raiseddarklesion,0.4ce dia. -Circularpilelesion,0.4co dia.,median lobe. -Corticalvacualationl,ocalareas,moderate -Nyocardititc,hronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropathy,moderate -Portalsonanucleacrellinfiltrates,ild Portalbileductproliferationm,ild Hyperplasticnodule -Vascularsintralizatiomni,ld Alveolareacrophagess,ild Species:Rat Project Number: 0281CROO12 Sumarized STAR Page: 119 3 10 Sumarized SingleTabulatedAnimalReport(continued). IndividualMacroscopicand KicroscopicObservations RikerLaboratoriesI,nc. 3K FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats -- ---------------Animal Number: IR-3744 Six: Male Group: Fate: (Weeka106)TerminalSacrifice 2) FN-3924 100 ppe Table:2 MicroscopicObservations(continued): LymphNode (sesenteric) Parathyroid Pituitary Sk.in -Not examined,missing -Not examined,not in planeof section -Adenota -Pododereatitisu,lcerative,hindleg,marked The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Karroo,Spleen,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Thyroid,Trachea,Esophagus,Pancreas, SalivaryGland,Eye. --- --- -------------- ------ -- --------- - - -------- Animal Number: IR-3745 Sex: Kale Group: 1 2) FK-3924100ppe Fate: (Weekz 14) FoundDead MacroscopicObservations: Heart Spleen Kidney Testis/Epididysis MicroscopicObservations: Aorta Kidney Liver Lung Pancreas Pirathyroid Spleen UrinaryBladder -Possiblyslightlyenlarged. -Possiblyslightlysmall. -Possiblehydronephrosiosf rightkidney. -Possiblyslightlyenlarged. -Not examined,missing -Hydronephrosisu,nilateral,moderate -negalocytesistild -Hemorrhage,perivascular,moderate -Not examined,missing -Not examined,not in planeof section -Atrophy,mild -Hemorrhage,focal,sild Epitheliahlyperplasias,imple,diffuse,mild Cystitis,acute,aild The followingtissuesmerefoundto be withinnormallimits: Brain,SpinalCord,DoneKarrow,Heart,Stomach,Small Intestine,LargeIntestine, Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)S,alivaryGland,Eye. --------------------------------------------------------- ------------------------- Species:Rat ProjectNumber:0291CM12 Sumarized STAR Page: 120 311 Sumarized SingleTabulatedAnimalReportleantinved) IndividualMacroscopicAnd MicroscopicObswvations RikerLaboratoriesI,nc. 3H FN-3924:Too Year OralToxicity-(McoginiciSttyudy in Rats Table:2 Animal Number: IR-3746 Sex: Nale Group: 1 2) FN-3924100 ppe Fate:(Week=106)TorainalSacrifice MacroscopicObservations: Pituitary MicroscopicObservations: Kidney Liver Lung Parithyraid Pituitary Testis/Epididysis -Smalldark lesion. -Chronicprogressivenephropathy,sild -Hapatocytovacoolationo,ultifocal,moderate Cystoiddegenerationo,ultifocalm,oderate -Vascularsintralizatioani,ld Alveolarmacrophages,mild -Not examined,not in planeof section -4wenosa -Vascularsineralizationm,ild The 4ollowingtissueswertfoundto be vithinnormallimits: Brain,SpinalCard,Done Harrom,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Prostate,Adrenal,Thyroid,Trachea,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryGland,Eye. ---------- ----- - ----- AnimalNuaber: IR-3749 Sti: Male Group: 2) Fit-3q24100 ppe Fate: tweekx 69) FoundDead MacroscopicObservations: UrinaryBladder Liver Lung MicroscopicObservations: Adrenal Aorta Eye Heart Liver Lung Pancreas Pituitary Prostate Spleen Stomach Testis/Epididysis -keaturia -Mottled -Hyperemic -Withinnormallimits One of pair present -Not examined,missing -Mthsis bulbi,unilateralm,arked -Nyocarditisc,hronicnonsuppurative, @UltifKal,lild -*ItKytt vacualation,@UltifK61, mild Necrosis,centrilobularm,oderate flegalocytosism,oderate -Vascularsineralizationm,ild -Not examined,missing -Not examined,missing -Not examined,missing -Mmosiderosis,mild Atrophy,mild -Necrosis,mcusal, moderate -Withinnormallimits One of pair present SpKiRS: Rat Projett Number: 02BICROO12 &marized STAR Page: 121 312 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3924:Too YearOral Toxicity-DncognicitSytudyin Rats ---- --------Animal Number: IR-3749 Sex: Hale Fate: (Week= 69) FoundDead Group: t 2) FN-3924100 pps Table:2 MicroscopicObservations(continued): The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Kidney,Small IntestineL,argeIntestine,UrinaryBladder, Thyroid,Parathyroid,Trachea,Esophagus,LymphNode (sesenteric)S,alivaryGland. ------------------------------------------- - ------ --- ----- Animal Number: IR-3750 Sex: Halt Broup: 2) FN-3924 100 ppe Fate:(Weekz 75)Sacrificedin extresis MacroscopicObservations: Liver MicroscopicObservations: Adrenal Heart Kidney Liver Lung LymphNode (sesenteric) Parathyroid Prostate SalivaryGland -Raised,1.5ce dia.nodulein leftlateral lobe. -Corticalvacuolatim,focal,mild Nodularhyperpl&siac,ortex,focal,mild -Myocarditisc,hronicnonsuppurativef,ocal, minimal -Chronicprogressivenephropithy,minimal -Portalmanonucleacrellinfiltratem,ild Portalbileductproliferatiosni,ld Necrosiso,ultifocals,ild Regalocytosit,marked Hepatocellulacrarcinm Largewelldifferentiatendeoplasm. Solid, moderatemitoticactivity. -Yascularmineralizationm,ild -Not examined,missing -Not examined,not in planeof section -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Stomach,SmallIntestine,UrinaryBladder,Aorta, Testis/EpididysisP,ituitary,LargeIntestine,Thyroid,Trachea,Esophagus,Pancreas,Eye. -- -------------- - ------ Animal Number: IR-3751 Sex: Hale group: 2) FN-3924 100 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Esophagus --- - -------------- -No visiblelesions. -Not examined,missing Species:Rat Project Number:0201MOO12 Summarized STAR Page: 122 313 Weirized SingleTabulatedAnimalReportlcontinved) Individualkcroscapic and MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:TiAoYear OralToxicity-ftcogeniciSttyudyin Rats - -----------Animal Number: IR-3751 Box: Nale Group: Fate: (Neek-1-06)TerminalSacrifice - ------2) FN-3924 100 ppe Table:2 MicroscopiOcbservations(cmtinued): Heart Kidney Liver Lung Parathyroid Pituitary Spleen Thyroid Trachea -Myocarditisc,hronicnonsuppuritive, localareas,mild .-Chronicprogressivenephropithy,moderate -Portalsononucleacrellinfiltratem,ild Portalbileductproli4eratims,ild Nepatocytevatuolationo,ultifocalm,oderate Cystoiddegenerationo,ulti4ocal,sild Negalocytosism,ild -Vascularmineralizationm,ild Perivasculamronuclear infiltrates,ild -Not examined,missing -Adencea -Hosasiderosism,ild -Not examined,missing -Not examined,missing The folloningtissuesNerefoundto be vithinnormallimits: Brain,SpinalCord,Bone HirroN,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder, Aorta,Testis/EpididysiAsd,renal,LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye, Prostate. -------------------------------------------------------------- - ---- ---------AnimalNumber: IR-3752 Sex: Male Group: 21 FN-3924 100 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Liver MicroscopicObservations: Heart Kidney Liver Lung Pancreas ------- ---- -Palo,raisedlesion,0.7 ca dii.,inright laterallobe. -Myocarditisc,hronicnonsuppurativef,ocal, minimal -Chronicprogressivenephropithy -Portalsonoiiucliciealrlinfiltratem,ild Portalbileductproliferationm,ild Hepatocellularcarcinoma Regalocytosis,minimal -Vascularmineralizationm,ild Hemorrhage,local areas, moderate -kiniiratrophy,marked Isletcellcarcinoma Moderatelypleowphic, encapsulatedv,ith infiltratioonf capsuleby tww calls. Vascularinvasion. Species:Rat ProjectNumber:OnIC0012 Summarized STAR Page: 123 314 SummarizedSingleTabulatedAnimalReport (continutdl IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats --- - -- ------------------- Animal Number: IR-3752 Sex: Kale Group: Fate: (Weeks106)TerminalSacrifice 2) FN-3924 100 ppe Table:2 MicroscopicObservationsicontinued): Parathyraid Spleen -Adenosa -Hetasiderosis,ild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder, Aorta,Testis/EpididysiPsr,ostate,Pituitary,Adrenal,Thyroid,Trachea,Esophagus, LymphNode (sesenteric)S,alivaryBland,Eye. ------------------------------- - -- -- --- -- ------------- Anisal Number:IR-3753 Sex: Nile Sroup: 1 2) FN-3924100 ppe Fate:fleeka ?4) Sacrificeidn extresis MacroscopicObservations: Spleen Liver -Enlarged -Enlargedandattled witha circularraised lesion,1.7 co dia.,on one median lobeandanothercircularlesion,0.6ca dia. on the othermedianlobe. Testis]Epididymis Thymus -Righttestissmall. -Dark hemorrhagiclesion, MicroscopicObservations: Adrenal Brain -Malignantlyaphosa,lymphocytic -Malignantlyaphoea,lymphocytic Large,hemorrhagiclesionwith saliciain cerebellum. Heart Kidney Liver -Malignantlyaphoma,lyaphocytic -Malignantlyaphoma,lysphkytic -HepatDcytevacualitionc,entrilobularm,arked Malignantlymphoma,lyaphocytic Regalocytosis,moderate S Necrosi centrilabularm,oderate Lung -Malignantlymphoma,lyaphocytic Hemorrhage,multifocal,mild LymphNode (sesenteric) -Hemorrhage,moderate Malignantlysphoma,lymphocytic Pancreas -Acinaratrophy,moderate Adenuma Malignantlymphava,lysphocytic Salivary61&nd -Not examined,missing Spleen Testis/Epididysis -Malignantlyaphona,lyaphocytic -Tubuleatrophy,ispereatogenesiusn,ilateral,' marked - --- - - ------------------ -- -- -- -- - BpKies: Rat ProjectNumber:0281MO12 SummarizedSTU Page: 124 315 Sumirized SingleTabulatedAnimalReport(continued)-. IndividualMacroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3H FN-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats ---- - ------------AnimalNumber: IR-3753 Sax: Nale Broup: Fate:(Weekz 94)Sacrificedin extresis 2) FK-3924 100 pps Table:2 MicroscopicObservations(continued): Thymus -Malignantlyaphosa,lymphocytic Thymusmarkedlyenlargedby neoplastic infiltrateand hemorrhage. The followingtissueswere foundto be withinnormallimits: SpinalCord,BoneNarrow,Stomach,SmallIntestine,LargeIntestine,UrinaryBladder,Aorta, Prostate,Pituitary,Thyroid,ParathyraidT,rachea,Esophagus,Eye. ---------------------------- -- --- ------------- Animal Number: IR-3754 Sex: Male Group: 2) FN-3924 100 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Pituitary Thyroid MicroscopicObservations: Adrenal Kidney Large Intestine Liver Lung LymphNode (sesenteric) Pancreas Pituitary Testis/Epididysis -Raisedmass,0.5 ce dia. -Possiblyslightlyenlarged. -Sinusaidaelctisia,cortex,moderate -Chronicprogressivenephropithy,moderate -Nesitodiasisc,olon -Pvtal manonucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hepatocytevacuolitions,ultifocalm,oderate Necrosis,iocal,minimal Negalocytosiss,ild -Vascularaineralizations,ild -Not examined,missing -Hyperplasiai,sletcell,sild -Adenoza -Polyarteritissi,ld The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,UrinaryBladder, Aorta,Prostate,Thyroid,Parathyroid,Trachea,Esophagus,SalivarySland,Eye. ------------ --- - --- --- ---- --- --- -------------------------------- Animal Number: IR-3755 Sex: Kale Group: 2) FN-3924100 ppe Fate: (Weekz106)TerminalSacrifice MacroscopicObservations: Skin Thyroid Pituitary Testis/Epididysis - ------ --------- -Circularraisedinflassedlesionson right and lefthind footpads. -Possiblyslightlyenlarged. -Bealldark lesion. -Righttestissmall. Species:Rat Project Number: ONICROO12 &marized STU Page:125 316 SummarizedSingleTabulatedAnimalReport (continvedl IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too YearOral 7oxicity-OncogeniciSttyudyin Rats --- --- -- --Anisal Number: IR-3755 Sex: Kale 6rDup: Fate: (Weeks106)TerminalSacrifice 2) FN-3924 100 ppe Table:2 MicroscopicO.bservations(continued): Adrenal Heart Kidney Liver Lung Parathyraid Pituitary Skin Testis/Epididysis -Corticavlacuolationo,ultifocalslild giousaidaelctasia,cortex,mild Nodularhyperplasiac,ortex,focal,sild -Myocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenophropithys,ild -Portalsononucltacrellinfiltratem,ild Portalbileductproliferatiosni,ld Cystaiddegenerationf,ocal,mild Regalocytosiss,ild -Vascularsineralizationm,ild Alveolarucrophages,mild -Hot examined,not in planeof section -Adenosa -PDdadermatitisu,lcerative,hindleg, bilateral,marked -Tubuleatrophy,aspereatogenesisu,nilateral, moderate The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Prostate,Thyroid,Trachea,Esophagus,LymphKode (sesenteric), Pancreas,SalivaryBland,Eye. ----------------------------- - -------- - ---- -- --- --- ----------------------Animal Number: IR-3756 Sex: Hale 6roup: 2) FN-3924 100 ppe Fate:(Week=105)Sacrificedin extrnis MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Heart Kidney Liver Lung LymphNode (sesenteric) -Enlarged,0.9 co in diameter -Corticavlacuolationf,ocal,sild Sinusoidalectasia,cortex,focal,sild -Myocarditisc,hronicnonsuppurative, sultifocalm,ild -Chronicprogressivenephropathy,mild -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Repatocytveacualationo,ultifocals,ild -Vascularsineralizationm,ild Hemorrhage,oultifocal,mild -Sinuscidalectasia,moderate Species:Rat Project Number: 0281CROO12 Susevized STAR Page: 126 317 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-ftcageniciSttyudyin Rats -- -- -- ---------------------- Animal Number: IR-3756 Sex: Kale Group: 1 2) FN-3924100 ppe Fat#:(Weekz105)Sacrificedin extresis Table:2 MicroscopicObservations(continued): Pituitary Spleen Urinary Bladder -1wenosa -Hemosiderosiss,ild -Epitheliahlyperplasias,imple,diffuse,sild The followingtissuesmere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Stomach,Small Intestine,Large Intestine,Aorta, Testis/EpididysisP,rostate,Thyroid,Parathyroid,Trachea,Esophagus,Pancreas,Salivarygland, Eye. --------------------------------- Animal Number: IR-3757 Sex: Kale Group: 21 FN-3924 100 pps Fate:(Week= 98)Sacrificedin extresis K,icroscopiOcbservations: Eye Pituitary MicroscopicObservations: Eye Kidney Liver Lung Pituitary Spleen Thyroid -Opacityof righteye. -Hemorrhagicmass, I x 0.0 ce dia. -Phthsisbulbilunilateral -Chronicprogressivenephropathy,sild -'Portaslononacleacrellinfiltratem,ild Portalbileductproliferatiosni,ld Hepatocytveicuolationogultifocals,ild negalocytosism,inimal -Vascularmineralizations,ild Alveolareacrophages,mild -Adenosa -Netosiderasisti,ld -C cell carcinoma The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysiPsr,ostate,Adrenal,ParithyroidT,rachea,Esophagus, LymphNode (mesenteric)P,ancreas,Salivarygland. ----------------------------- - -- --- --- --------------------------------------- Animal Number: IR-3758 Sex: Male Group: ( 2) FM-3924100 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: -No visiblelesions. MicroscopicObservations: Adrenal -Urtical vacuolitionl,ocalareas,moderate NodularhyptrplasiiCio,rtex,fK&I, mild -------------------------------- --- --- -- ----------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 127 3 18 SummarizedSingleTabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncovenicitSYtudy in Rats Table:2 Animal Number: IR-3758 SIX:Halt Broup: 2) FN-3q24 100 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations(continued): Kidney Liver Lung Lymph Node (sesenteric) Testis/Epididysis Trachea -Chronicprogressivenephropathy,mild Hydronephrosisb,ilateral,moderate -Portalsononucleacrellinfiltratem,ild Portalbileductproliftriitimmi,ld Hepatocytveicuolationo,ultifocals,ild Necrosiso,ultifecals,ild Regalocytosis,moderate Pigment,oultifocalm,ild -Yucularmineralizationm,ild Alveolareacrophages,mild -Hemorrhage,minimal -Vascularmineralizationm,ild -Tracheitisc,hronic,sild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Prostate,Pituitary,Thyroid,ParathyraidE,sophagus,Pancreas, .SalivaryB.land, Eye. -- -- -- -- -- --- ------- Anisal Number:IR-375q Sex: Male Broup: 2) FN-3924100 ppe Fate: (Neekz106)TerminalSacrifice MacroscopicObservations: Pituitary MicroscopicObservations: Kidney Liver Lung Pituitary Spleen Testis/Epididysis -- --- -- ---- - -- -Circularmass,0.5 cm dia. -Chronicprogressivenephropathy,moderate -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld Cystaiddegenerationf,ocal,mild Kepatocytealteration,vacuolateds,ild Regalocytosis,moderate Hopatocytevacuolation,oultifocal,moderate -Vascularmineralizationm,ild Pneumonia,interstitialc,hronic,oulti4ocal, mild Alveolarsacrophiges,moderate Perivasculamrononucleairnfiltrate,mild Hemorrhage,local areas, marked -Adenama -Notosiderasis,ild -Tubuleatrophy,aspereatogene6iwsi,litwalp sild Species:Rat Project Number: 0201MOO12 Summarized STAR Page: 120@ 319 Smarized SingleTabulatedAnimalRtPorttcantinued) IndividualMacroscopicAnd MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too Year OralToxicity-WcagenicitSytudyin Rats --- - -- --- ---- -- -- -- - Animal Number: IR-3759 Six: Kale Fate: (Upokm106)TerminalSacrifice group:( 2) FN-3924100 ppe Table:2 MicroscopicObservationstcontinued): UrinaryBladder -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Heart,Stomach,SmallIntestine,LargeIntestine,Aorta, Prostate,Adrenal,Thyroid,Parithyraid,Trachea,Esophagus,LymphNode itesenteric)P,ancreas, SalivaryGland,Eye. -------------------------------- - -- -- --- --------------------- AnimalNumber: IR-3760 Six:Halt Group: 2) FN-3924 100 pps Fate: (Week-1-06)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Heart Kidney Liver Lung Pancreas P,irathyraid Thyroid -k visiblelesions. -Medullarcyellhyperplasiaf,ocal,sild -Myocardiaflibrosisf,ocal,sild Myocarditispchronicnonsuppurative, sultifocala,ild -Chronicprogressivenephropathy,mild -Portalsononucleacrellinfiltratem,ild Hepitocytevacuolationo,ultifocalm,oderate Necrosiso,ultifocals,ild Regilocytosis,moderate -Yasculimrineralizatims,ild Pneumonia,interstitialc,hronic,oultifocal, mild Alveolarmacrophages,sild -Hyperplasiii,sletcall,moderate -Not examined,missing -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Spleen,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Testis/EpididysisP,rostate,Pituitary,Trachea,Esophagus, LymphNode (sesenteric)S,alivaryBland,Eye. ------------------ - --- -- --- ------------------------- Sptcies:Rat Project Number: 0281CROO12 Susarized STAR Page: 129 320 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3924:Too YearOral 7oxicity-OncoginiciSttyudyin Rats Table:2 AnimalNumber: IR-4756 Sax: Female Broup: 2) FN-3924 100 pps Fate: (Week= BO) Sacrificedin extromis MacroscopicObservitions: Mammary Blind Pituitary Adrenal Eye MicroscopicObservations: Adrenal Eye Liver Lung Mammary gland Parathyraid Pituitary Spleen -Ulceratedoultilobulamrass,5 1 2.5 1 1 ca, right&sill&;pale mass, 2 1 1 cm,rightinguinalarea. -Hemorrhagicmass, 0.7 ce dia. -Leftadrenalenlarged,I to dii. -Atrophyof lefteye -Sinusaidaelctasia,cortex,unilateral, marked -Phthsisbalbi,unilateral -Nesatopoitsise,xtramedullarys,ild Necrosis,@UltifKal,mild -Vascularmineralizations,ild Metastaticneoplasm -Adenocarcinama Threesectionsof tumorpresent. Allof a welldifferentiatedductularneoplasmwith necrosisand vascularinvasion.Lung metistim similarto primary. -Notexamined,not in planeof section -Adencea -Beeatopciesise,xtrasedullaryi,ncreased, moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Karrov,Kidney,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Trachea,Thyroid,Esophagus,LymphNode lsesenteric), Pancreas,SalivaryBland. --- ---------------- -------------- --- -------------- --- ---------- ---------------Animal Number: IR-4758 Sez: Female Group: 2) Fli-3924100 ppe Fite: (Week= 89) FoundDead MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Esophagus Eye Kidney LargeIntestine ----- -------------------- -Raisedhemorrhagicmass, 1.5x I ca'. -Sinusoidaelctisia,cortex,mild -Not examined,missing -Not examined,missing -Pelvicmineralizationm,oderate Calculus,Pelvic -Not examined,missing - -- -- - -- --- -- Species:Rat ProjectNumber:OMICM12 SummarizedSTAR Page: 130- 321 SusaarizedSingleTabulatedAnimalReport (continuw) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N Flf-3?24T:oo Year Oral Toxicity-ftcogeniciSttyudyin Rats Table;2 Animal Number: IR-4759 Six:Female Broup: 2) FN-3924 100 ppe Fate: (Meek= 69) FoundDead MicroscopiOcbservations(cmtinued): Liver Lung Lymph Node (sesenteric) NineiryBland Ovary Pancreas Parathyroid Pituitary SalivaryBland StillIntestine Spleen Thyroid Uterus -Portilbileductproliferatiosni,ld Hepatocytevacuolation,diffuse,moderate -Alvealirmacrophagess,ild Pneumonia,acuteexudative,localareas,sild Vascularsineralizitiosni,ld -Not examined,missing -Not examined,missing -Not examined,missing -Hyperplasiai,sletcell,sild -Not examined,missing -Adenoma -Not examined,missing -Not examined,missing -Hemosiderosis,moderate -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: SpinalCord,Bone Narrow,Heart,Stomach,UriniryBladder,Aorta,Trachea,Brain. - -- --------- AnimilNumber: IR-4759 Sex: Female Group: 2) FN-3924 100 ppe Fite: (Week=105)TerminalSacrifice MacroscopicObservations: Mammary Bland Liver MicroscopicObservations: Adrenal Kidney Liver Lung HassiryGland Ovary Pancreas Pituitary Uterus -Mass,4 x 3 ce,leftaxilli;6 x 5 x 2 ce, rightinguinalarea. -Appearsmottled -Sinusaidilectasia,cortex,marked -Pigment,conv.tub. epitheliumm,ild -Hepatocytveacuniationp,eripartilm,oderate Regalocytosism,ild -Hemorrhagel,ocilartas,mild Vascularsineralizationm,ild -Fibroadenm Fibroadenosa -Tubularhyperplasiib,ilateral,moderate -Acinaratrophy,aild -Adenosa -Cysticglands,sild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Splm, Heart,Stomach,SmallIntestineL,arge Intestine, species:Rat Project Number: 02BICROO12 SussarizW STAR Page: 131 322 Sumarized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand NicroscopitObservations RikerLaboratoriesI,nc. 3K FN-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-4759 Sax: Fesile Group: 2) FN-3924100 ppe Fate: (Weekz105)TerminalSacrifice MicroscopicObservations(continued): The followingtissues*erefoundto be withinnormallimits(continued): UrinaryBladder,Aorta,Trachea,Thyroid,Parathyroid,Esophagus,LymphNode (sesenteric), SalivaryGland,Eye. -------------------------- - - --- -- --------Animal Number: IR-4762 Sex: Female Group: 2) F?1-3q24100 pps Fate:(Week=105)TerminalSacrifice MicroscopicObservations: Pituitary Liver MicroscopicObservations: Adrenal Kidney Liver Lung Ovary Pituitary spleen Thyroid -Hemorrhagicmass, 0.6 co dia. -Darkin color!raisedcircularlesion,1.5ce dia.,medianlobe!circular lesion,I ce dim.,rightanteriorlobe; circularlesion,0.9 tt dia.,caudate lobe. -Sinusoidaelctasia,corteilsild -Chronicprogressivenophropathy,mild Pigment,conv.tub. epithelium,sild -Portalmanonucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hopatocytevacualation,diffuse,moderate Repatocytealterationv,icuclateds,ild Hyperplasticnodule Regalacytosis,moderate -Nnarrhige,sultifocalm,ild Vascularsineralizationm,ild Pneusmia,interstitialc,hronic,oultifocal, mild Alveolarsacrophages,moderate Perivisculasronanucleiirnfiltratem,oderate -Tubularhyperplasiab,ilateral,moderate -Adenoaa -Hesasiderosits,ild -C cell adenoaa The followingtissuesmere foundto be withinnormallimits: Brain,SpinalCord,Bme Narrow,Heart,Stomach,Small IntestineL,arge Intestine, UrinaryBladder,Aerti,Uterus,MammaryGland,Trachea,Parathyroid,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 132 323 Smarized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too Yor Oral Toxicity-NcogenicitSytudyin Rats Table:2 Animal Number: IR-4764 Six:Female &W: Fate: (Neekz105)TerminalSacrifice 2) W3924 100 pps MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Esophagus Kidney Large Intestine Liver Lung LymphNode (sesenteric) Ovary Pituitary Spleen -Largehemorrhagicmass, 1.2ce dia. -Sinusoidaelctasia,cortex,mild -Not examined,missing -Chronicprogressivenephropathy,mild Pelvicsintralizatiomni,ld -Nematediasitc,olon -Nepatocytveicualationo,ultifocalm,ild Knalocytosis,mild -Yascularsineralizationm,ild Alveolarmacrophagn,sild -Hemorrhage,moderate -Tubularhyperplasiab,ilateral,mild -Adenomi -Nesosiderosiss,ild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,DoneNarrow,Heart,Small Intestine,UrinaryBladder,Aorta,Uterus, MammarySlind,Trachea,Thyroid,Parathyroid,Pancreas,SalivaryBlind,Eye, Stomach. --------------------------- - -- ------- Anisal Number:IR-4765 Sex: Female Group: t 2) FN-3924100ppe Fate: (Weeks105) TerminalSacrifice MacroscopicObservations: Pituitary Liver MicroscopicObservations: Liver Lung Parithyraid Thyroid -Clearfluidfilledcyst,0.5 co dia. -Appearsmottled -Portalamonucleircellinfiltratem,ild Portalbileductproliferationm,ild Nepatacytevacuolationl,ocalareas,mild flegilocytosiasi,ld -Yascularminerilizationm,ild -Notexamined,not in planeo4 section -HyperplasiaC, cell,moderate The followingtissuesmere foundto be withinnormallimits: Brain,SpinalCord,Done Narrow,Kidney,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Trachea,Esophagus,LymphNode (sesenteric)P,ancreas, SalivarySland,Namary Sland,Pituitary,Adrenal,Eye, Spleen. SoKies: Rat ProjectNumber:ONICRO12 Suewized STAR Page:In 324 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroseopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats --- --- -- ---- Animal Number: IR-4766 Sax: Female Group: 1 2) FN-3924100 ppe Fate: (Week-105)TerminalSacrifice Table:2 MacroscopicObservations: MicroscopicObservations: Adrenal Kidney Liver Lung -No visiblelesions. -Sinusoidielctisia,cortex,mild -Pelvicmineralizatione,irimal Pigment,conv.tub. epitheliumm,ild -Hepatocytvoacuolationo,ultifocals,ild Regalocytosis,moderate Pigment,bepatocyte,mild -Alveolarsacrophages,sild Hemorrhage,oultifocals,ild 't'hfeollowingtissueswerefoundto be withinnormallimits: Brain,SpinalCord, Done Narrow,Spleen,Heart, Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Ramary Gland,Pituitary,Trachea,Thyroid,Parathyraid, Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. ----------- ----- - ---------------- ------------------------------ Animal Number: IR-4767 Sex: Female Group: 2) FN-3924100 ppt Fate: (Week=105)TerminalSacrifice MacroscopicObservations: Pitui4ary MicroscopicObservations: Adrenal Ki,ul.iey Lun; Ovary Parathyraid Pituitary Spleen Uterus -Raised&ass,I ce dia. -Sinusaidaelctasia,cortex,mild -Pelvicmineralizationo,ilgd -Kepitacytveacuolationd,iffuse,moderate Cystaiddegenerationo,ultifocaltlild Megilocytosis,moderate Resitapoiesise,xtrasedullarym,ild -Vascularmineralizationm,ild Alveolarucrophages,sild -Tubularhyperplasiau,nilaterals,ild Cyst,unilateral -Not examined,not in planeof section -Adenama -Heicsiderasis,ild -Cysticglands,sild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Rene Narrow,Heart,Stomach,Small Intestine,LargeIntestifte, UrinaryBladder,Aorta, MammaryGland,Trachea,Thyroid,Esophagus,Lymph Node (sesenteric), Pancreas,SalivaryGland,Eye. ------------------------------------------------------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 134 325 Sumarized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year OralToxicity-OncogeniciSttyudy in Rats - ---- ----Animal Number: IR-4768 Sex: Feeale Group: 2) FN-3924100 ppe Fate: (Week=105)TerminalSacrifice Table:2 MacroscopicObservations: Eye Pituitary Liver MicroscopicObservations: Adrenal Eye Kidney Liver Ovary Parithyraid Pituitary Spleen Thyroid -Righteye inflassedand cloudy. -Mass,0.7 ce dia. -Slightlypale and mottled. -Corticalvacuolationl,ocalareas,marked Sinusoidalectasia,cortex,mild -Panophthalsitiusn,ilateral,marked -Chronicprogressivenephropathy,mild -Nepatocytevicuolationp,eriportalm,oderate Regalocytosism,ild -Tubularhyperplasiab,ilateral,moderate -Notexamined,not in planeof section -4wenona -Hesosiderasism,ild 4allicularhyperplasiac,ystic,unilateral, marked The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,DoneMarro*,Heart,Lung,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,MammaryGland,Trachea,Esophagus,Lymph Mode (Nesenteric), Pancreas,SalivaryBlind. - ------------------------------- --- - ---- - ----Animal Number: IR-4769 Sex: Female Broup: 1 2) FN-3924100 ppe Fate: (Weekz105)TerminalSacrifice RacrciscopiOcbservations: Mammary Gland -Mass,6 x 4 x 2 ce in leftaxilla;6 1 4 1 2 ce, in leftinguinalarea. MicroscopicObservations: Adrenal Kidney Liver -Sinusaidaelctasia,cortex,sild -Chronicprogressivenephropithym,ild -Nepatacytevicuolationm,ultifocalm,ild Regalocytosism,ild Nepatacytealterationb,asophilics,ild Lung -Vascularsineralizationm,ild Alveolareacrophagess,ild Ntearrhage,localareas,mild Raneary Gland -Fibroadenoma AdInKarcinosa Ovary -Tubularhyperplisiab,ilateral,moderate Pituitary -AdenDaa ------------- --------------- ------------------ --- - Species:Rat Project Number: 0281CROO12 Suawized STAR Page: 135 326 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand RicrostapicObservations RikerLaboratoriesI,nc. 3H FN-3924:two Year OralToxicity-OncogeniciSttyudyin Rats -- - - ------Animal Number: IR-4769 Sex: Feeile Group: 2) FN-3924100 ppo Fate: (Neekz105)TerminalSacrifice Table:2 MicroscopicObservations(continued): Uterus -Hydrosetra,moderate The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Trachea,Thyroid,Parithyroid,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryGland,Eye. - ---------------------- -- - - --------- Animal Number: IR-4770 Sex:Fesile Group: 2) FN-3924 100 pps Fate: (leek=105)TerminalSacrifice MacroscopicObservations: Hassary Gland Liver MicroscopicObservations: Adrenal Liver Lung hass,iryGland Pancreas Pituitary Spleen -Mass,4 1 4 1 1 cm, in throatarea. -Appearsauttled -Sinusoidalectasia,cortex,moderate -Nepatocytiviacuolation,peripartal,moderate Regalocytosit,moderate Pigeent,hopatocyte,minimal -Vascularmineralizatio'-nm,ild'* Alveolareacrophages,moderate Perivasculamrmonuclearinfiltratem,ild -Fibroadenaaa -Acinaradenona -Adenm -Hemosiderosism,ild The followingtissues*ere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Kidney,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Ovary,Trachea,Thyroid,Parathyraid,Esophagus, LymphNode (sesenteric)S,alivary61and,Eye. - - - --- -- -- ---------------------------------------------- Animal Number: IR-4771 Sex: Female Group:( 2) FN-3924100 ppe Fite:(Week= 91)Sacrificeidn extresis MacroscopicObservations: Pituitary Liver MicroscopicObservations: Adrenal ----------------- - -Hemorrhagicmass,0.6 ce dia. -Appearsdark brownin colorwith multiple palefocion all lobes. -Corticavlicualations,ild Sinusoidaelctisia,cortex,sild -------- - -------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 136 327 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObw vations RikerLaboritoriesIpnc. 3N Fli-3924T:oo Year OralToxicity-OncogeniciSttyudy in Rats Table:2 Animal Number: IR-4771 Sex: Female Sroup: 2) FN-3924 100pps Fate: (Neeka 91)Sacrificeidn extresis MicroscopicObservationslcontinued): Kidney Liver Lung Pituitary -Pelvicmineralizationm,inimal Vacuolationc,onv.tub. epitheius,mild -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld P-epatocytveacuolation,peripqrtal,moderate -Yascularmineralizationm,ild Alveolareacrophagess,ild Perivasculasrononucleairnfiltrates,ild Hemorrhage,diffuse,marked -Adenona The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Oviry,MammaryBlind,Trachea,Thyroid,Parathyroid,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland,Eye. ------------- --- --------------- - - -- --- -------------- Animal Number: IR-4772 Sex: Feeale Group:1 2) M3924 100 pps Fate: (Week=105)TerminalSacrifice MacroscopicObservations: Liver MicroscopicObservations: Adrenal Kidney Liver Lung Lymph Node lmesenteric) Mammary Blind Parathyroid Thyroid -Circula*rass,2 1 1.2ce, in right posterior. -Corticalvicualations,ild Sinuscidalectasia,cortex,marked -Chronicprogressivenophropathy,minimal Pelvicmineralizationm,inimal -NeQaIKYt*SiS,moderate Hyperplasticnodule Htp&tKtIlUlafadenusa Largetow withareasof necrosis.Tumor cellslarge,many vacuolated. -Vascularmineralizationi,iild Pneumonia,interstitialc,hronic,oultifocal, sild -Not examined,missing -6&lactoctle -Hyperplasiao,ulti4ocalm,ild -HyperplasiaC,cell,oultifocalm,ild The followingtissuesverefoundto be oithinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, Species:Rat hoject Number:0281CH012 Sumarized STAR Page: in 328 SummarizedSingleTabulatedAnisal.Reparticentinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-NcogenicitSytudyin Rats Table,.2 Animal Number: IR-4772 Sex:Female Group: ( 2) FI-3924100 ppe Fitt:(Neekx105)TerminalSacrifice MicroscopicObservations(continued): The followingtissueswerefoundto be withinnormallimits(continued): UrinaryBladder,Aorta,Uterus,Ovary,Pituitary,Trachea,Esophagus,SalivaryGland,Eye, Pancreas. --------------------------- - --- ------------ Animal Number: IR-4773 Sex: Female Group: 21 FN-3924 100 ppe Fite: (Weeks105)TerminalSacrifice MacroscopicObservations: Mammary Gland Liver MicroscopicObservations: Adrenal Kidney LargeIntestine Liver Lung LymphNode (sesenteric) Mammary Gland Ovary Pituitary -Smallulceratedmass,2 ce dia.,on right side. -Pale,slightlyraisedmass,3 1 2 ce, in median lobe. -Sinusoidaelctasia,cortex,marked -Pigment,cony.tub. epithelium,brown, minimal -Nmtodiasir,,colon -Hyperplastincodule Hepatocytaelteritionv,icualatedo,ultifocal, mild Magalocytosis,moderate Nepatacytevacualitiono,ultifocalm,ild -Vascularsineralizatiosni,ld Alveolarmacrophageso,ultifocils,ild Perivisculagrononucleiirnfiltratem,inimal -Hemorrhage,mild -Adenocarcinosad,uctal Adenocarcinotad,uctil Both grosslesionswereadenocircinomis.One was ulcerated. -Cyst,folliculiru,nilateral -Adenosa The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrom,Spleen,Heart,Stomach,SmallIntestine,UrinaryBladder, Aorta,Uterus,Trachei,Thyroid,Parathyroid,Esophagus,Pancreas,SalivaryGland,Eye. --- ---- -------------------------- ------ ---------- - ------ Species:Rit ProjectNueber: 0261CROO12 &mmarized STAR Page. 138 329 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations Riker Laboratories,Inc. 3H FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats --- --------------Animal Number: IR-4774 Sex: Female Group: Fate:(Week= 92)Sacrificedin extreais 2) FN-3924 100 ppe Table:2 MacroscopicObservations: Pituitary Liver HicrOSEOPiC Observations: Adrenal Kidney Liver Lung Parathyroid Pituitary Urinary Bladder -Raisedhemorrhagicmass, 1.1 ce dia. -Somewhatpale and mottled. -Corticalvacualation4,ocal,unilaterals,ild -Pelvicmineralizationm,inimal. Pyelitis,acute,sild Vacualitionc,dnv.tub.epitheiuss,ild -Portalsononucleacrellinfiltratem,inimal Portalbileductproliferatioani,ld Repatocytevacuolation,diffuse,marked Negalocytosis,moderate Necrosis,focal,mild -Vascularsiieralizatiomni,ld -Not examined,not in planeof section -Adenusa -Epitheliahlyperplasias,imple,diffuse,sild The followingtissueswe foundto be withinnormallimits: Brain,SpinalCord,DoneKarroo,Spleen,Heart,Stomach,Small-IntestineL,arge Intestine, Aorta,Uterus,Ovary,Mammary61and,Trachea,Thyroid,Esophagus,Lymph Node (sesenteric), Pancreas,Salivary61and,Eye. -------------------------------------- ------ - ------------- ------------------------Animal Number: IR-4776 Sex: Female Group: 2) FN-3924100 ppe Fate: (Week=105) TerminalSacrifice MacroscopicObservations: Ovary MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Ovary Spleen -Hemorrhagiccyst,I co dia.,rightovary. -Sinusaidaelctasia,cortex,unilateral, marked -Not examined,missing -Chronicprogressivenephropathy,sild -Portalsononucleacrellinfiltratem,inimal Hepatacytveacuolationo,ultifocals,ild Regalocytosiss,ild Hyperplasticnodule -Vascularmineralizationm,ild -Cyst,follicularb,ilateral -Hesosiderosiss,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,SmallIntestine,LargeIntestine, --------------- ---- -- -- Species:Rat Project Number: 0221CROO12 Snurized STAR Page: 139 330 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacrescopicand NicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Yoxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-4776 Sex: Female Broup:( 2) FN-3924100 ppe Fate: (Weeks105)TerminalSacrifice NicroscopiOcbservations(continued): Thefollowingtissueswerefoundto be withinnormallimits(continued): UrinaryBladder,Aorta,Pituitary,Trachea,Thyroid,ParathyroidL,ymphMade (sesenteric), Pancreas,Salivary61&nd,Eye, NasearyBland,Uterus. - ------------------------------------- Animal Number: IR-4777 Set: Female 6roup: 2) W3q24 100ppe Fate: (Week= 82) FoundDead Microscopic Observations: Pituitary NicroscopicObservations: Eye Liver Lung Pancreas Pituitary -Hemorrhagicmass, 0.6 K O.q ce. -Not examined,missing -Repatocytvoactkolatioonu,ltifocal,mild Regiilocytosimsi,ld -Pneumoniaa,cuteexudative,localareas,sild Hemorrhage,oultifocal,mild -kinar atrophy,localareas,moderate -Adenoma The followingtissuesmerefoundto be withinnormallimits: Brain,SpinalCord,DoneNarrou,Spleen,Kidney,Heart,Stomach,SmallIntestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,NammaryGland,Trachea,Adrenal, Thyroid,Parithyroid,Esophagus,LymphNode (sesenteric)S,alivary61and. ---------------------------------- - ---- -- --- --- ----------------- -- Animal Number: IR-4778 Sex: Feeale Broup: 2) FN-3924 100 pps Fate: (Week=105)TerminalSacrifice NicroscopicObservations: NicroscapicObservations: Adrenal Kidney LargeIntestine Liver Long --- --------- -No visiblelesions. -Sinusaidaelctisia,cortex,unilateral, marked -Chronicprogressivenephropathy,mild Pelvicmineralizationm,inimal -Nmtodiasis,colm -Portalsononacleacrellinfiltratem,inimal NegilDcytosiss,ild Hepatocytevacuolation,oultifocal,moderate Portalbileductproliferatiosni,ld -Alveolareacrophagesf,ocal,sild Perivasculamrnonuclear infiltratef,K&I, mild - ------ Species:Rat ProjectNumber:0281CM12 Swaarized STU Page: 140 331 Smarized SingleTabulateAdnimalReportlcontinued)IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too Year OralToxicity-OncogeniciSttyudyin Rats Table:2 AnimalNumber:IR-4778 Six: Female Group: 2) FN-3924100 ppa Fite:(Veekz105)TerminalSacrifice MicroscopiOcbservation(scontinued): The followintgissueswerefoundto be withinnormillimits: Brain,SpinilCord,BoneNarrow,Spleen,Heart,Stomach,SmallIntestineU,rinaryBladder, Aorta,Uterus,Ovary,HimetryGland,Pituitary,Trachea,Thyroid,ParathyroidE,sophagus, LymphNode (tesenteric)P,ancreas,SalivaryGland,Eye. --- ------------------- ------ AnimilNumber:IR-4781 Sex: Female Group: 2) Fff-3q21400 pps Fate:(Week=51)Sacrificeidn ektresis MacroscopicObservations: Spleen Liver Large Intestine MicroscopicObservations: Adrenal LargeIntestine Liver Lung Lymph Node(wsenteric) -Appearssmall -Smallpalefoci,approximatel0y.2 cm dia., in leftlateralobe. -Beginninwgiththerectue,the colon,cecus and ileumire enlargedand filledwithfecalmaterial.Sectionof rectumappearsenlargedand thickened. -Sinusoidaelctasiac,ortex,minimal -Leiomyosarcoma Largewelldifferentiatteudw . Moderate nuclearpleosurphiss.Invadesmucosa. -%alocytosis,moderate Necrosiso,ultifocals,ild -Alveolareacrophagesf,ocal,sild -Hemorrhages,ild The followintgissuesmerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Kidney,Heart,Stomach,Small Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Hamiry Gland,PituitaryT,rachea,Thyroid,Parithyroid, Esophagus,Pancreas,SalivaryGland,Eye. --- ---- -- --------------- - --- ------- - -- --- -------------------------- AnimalNumber: IR-4784 Sex: Female Group: 2) FN-3924100 ppe Fite:(Week-105)TerminaSlacrifice MicroscopicObservations: HassiryGland Liver MicroscopicObservations: Kidney -Lobular%ass,2 1 1 x I ce, in leftinguinal area. -Multiplpealefociin leftlateralobe. -Pelvicmineralizatiomnipnimal metastaticneoplasm Species:Rat ProjectNumber:OHICM12 Summarized STAR Page: 141 332 SummarizedJingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Dral Toxicity-OncogeniciSttyudyin Rits Table:2 Animal Number: IR-4784 Sex:Fesile Broup: 2) FN-3924 100 ppe Fite: (Week=105)TerminalSacrifice MicroscopicObservations(continued): Liver Lung Lymph Node lmesenteric) Mammary Gland Ovary Parathyraid Pituitary SalivaryBland SPIM -Repatacytveacualationo,ultifocals,ild Regalocytosism,ild -Yascularsinerilizatiomni,ld Pneumonia,interstitialc,hronic,oultifocal, minimal Alveolarmacrophageso,ultifocals,ild Perivasculasrononucleairnfiltrates,ild -Not examined,missing -AdenK&rcinoss Highlycellular,cysticareas. Lymphatic invasion.Metastaticto capsularsurfaceof one kidney. -Tubularhyperplasiab,ilateral,moderate -Not examined,not in planeof section -Adenoma -Sialidenitisc,hronic,moderate -Hetosiderosism,ild The folloving-tissueiserefoundto be mithinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,SmallIntestine,Large Intesti-ne, UrinaryBladder,Aorta,Uterus,Trachea,Adrenal,Thyroid,Esophagus,Pancreas,Eye. ------------------------------- - -------- Anisal Number:IR-4786 Sex: Female-Broup: 2) FN-3924100 ppe Fate:(Weeks102)Sacrificeidn extresis MacroscopicObservatims: Pituitary Mammary Sland Liver -Dirkraisedhemorrhagicmass,I ca dii. -Lobulatemdass,I ce dia.,in rightaxilla; similarmassin leftinguinalarea. -Raisedmass,3 1 1.5ce, in rightlateral lobe. MicroscopicObservations: Adrenal Aorta Kidney Liver -Sinusaidalectisia,cortex,moderate -Not examined,missing -Pelvicminerilizationm,inimal -Hopatocytevacuolation,periportal,moderate Negalocytosism,ild Nepatacellularcarcinoma Nelldifferentiatetdr,abecularpattern. Areasof necrosis.Moderatemitotic activity. ----------------- ---------- --------- ---- --- ----------7--------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 142 333 SummarizedSingleTabulatedAniul Report(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3924:Too Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-4786 Sex: Female Broup: 2) FN-3924 100 ppo Fate:(Neekz102)Sacrificedin extresis MicroscopicObservations(continued): Lung Hass,iry61and Parathyraid Pituitary Spleen Uterus -Vascularmineralizationm,ild Alveolarmacrophageso,ultifocal,mild -Adenocarcinosa Fibroadenosa -Notexamined,not in planeof section -Adenuma -Hemosiderosis,moderate -Cysticglands,sild The follovingtissuesmere foundto be mithinnormallimits: Brain,SpinalCord,Bone KarroitH,eart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Ovary,Trachea,Thyroid,Esophagus,LymphNode (sesenteric)P,ancreas, SalivaryGland,Eye. --- ---------------------------- - - ---------- - Animal Number: IR-4789 Sex: Female 6roup: 2) FN-3924100 pps Fite:(Week=93) Sacrificeidn extreeis ------ MacroscopicObservations: Pituitary Liver MicroscopicObservations: Adrenal Kidney Liver Lung LymphNode (sesenteric) Parathyroid Pituitary Stomach -Hemorrhagicoas"sg-6.c7e dia. -Scatteredsmallpale foci in most lobes. -Corticavlacuolationi,ocal,unilaterals,ild Siousoidaelctasia,cortex,focal,unilateral, moderate Nodularhyperplasiac,ortex,focal, unilateralm,ild -Vicualationc,ony.tub. epitheius,minimal -RepstDcytveacuolationp,eriportals,ild Regalocytosis,moderate Necrosis,sulti4ocalslild -Vascularmineralizations,ild Pneuaoniai,nterstitialc,hronic,oultifocal, sild Alveolareacrophages,focal,mild -Not examined,missing -Not examined,not in planeof section -Adenoma -6&stritis,acute,moderate The folloningtissuesverefoundto be oithinnormallimits: Brain,SpinalCord,Bone Marrou,Spleen,Heart,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Ramary 61and, Trachea,Thyroid,Esophagus,Pancreas, ------------- --- -------------- --- ----------------------- Species:Rat Project Number: 0261CROO12 Summarized STAR Page: 143 334 SummarizedSingleTabulatedAnimalReport (Etmtinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too Year OralToxicity-OncoginiciSttyudyin Rats --------------------------------- ----Animal Number: IR-478q Sex: Feeale Group:( 2) FN-3924100 ppe Fate:(Week= 93) Sacrificeidn extresis Table:2 MicroscopicObservations(continued): The followingtissuesmere foundto be withinnormallimits(continued): SalivaryGland,Eye. -------------------------------- - -- -------------- ------ Animal Number: IR-4790 Sex: Female Group: t 2) FN-3924100 ppe Fate:Ikeekz 76)Sacrificeidn extresis MicroscopicObservations: Mammary Gland MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung LymphNode (sesenteric) Nammary Gland Ovary Pancreas Parithyroid Pituitary SalivaryGland SpinalCord Thyroid Trachea Uterus -Largemass,7 x 8 x 2.5 ca in rightinguinal area;ulcerated,bleedingarea on surface.Upon incision,mass foundto contain cysticareas. -Not examined,missing -Not examined,missing -Pelvicmintralizatiormii,nimal -Hipatacytveacuolationo,ultifocals,ild Negalocytosiss,ild -Vasculamrintralizitiosni,ld Alveolars-acrophiges@6cal,sildPerivisculamranonucleairnfiltrates,ild -Not examined,missing -Adenocarcinosac,ystic -Not examined, missing -Not examined, missing -Not examined, missing -Not examined, missing -Not examined, missing -Not examined, lost duringprocessing -Not examined, missing -Not examined, missing -Not examined, missing The followingtissueswere foundto be withinnormallimits: Brain,BaneMarro*,Spleen,Heart,Stomach,Small Intestine,LargeIntestine,UrinaryBladder, Aorta,Eye. ------------------------------------------------------------------------------------ Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 144 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-4791 Sex:Female SW: Fate:(Neekz 65) Sacrificeidn extresis 2) FK-3924100 pps MacroscopicObservations: Pituitary MicroscopicObservations: Kidney Liver Lung Pituitary Spleen -Reddish@ass,I 1 0.0 ce. -Vicuolationc,onv.tub. epitheium,minimal -HeP&tKytt V&CUDIatiOn,periportal,mild Negalocytosiss,ild Hyperplasticnodule -Yascularmineralizationm,ild Pelvicmineralizationm,ild -Adenosa -Hemosiderosis,mild The followingtissuesmere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Heart,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Uterus,Ovary,Ramary Gland,Trachea,Adrenal,Thyroid,Parathyroid, Esophagus,LymphNode (sesenteric)P,ancreas,SalivaryGland,Eye. -------------------------------------- - - --- - --- ---------------------- - Animal Number: IR-4792 Sex: Female Group: 2) Ffl-3924100 ppe Fate: (Week=105)TerminalSicrifice MacroscopicObservations: MingaryBlind MicroscopicObservations: Adrenal Kidney Liver Lung Mammary Blind Pancreas Pituitary -Hass,2 cm dia.,in rightaxilla; oultilobulamriss,4 1 3 x 2 ca, in perineal area. -Sinusaidatlctasia,cortex,moderate -Pelvicmineralizationm,ild -Hepatocytveacuolitiono,ultifocalm,ild Regalocytosism,ild Pigment,brown,bepatocytes,minimal Hyperplasticnodule -Yascularsineralizitiosni,ld Alveolarmacrophiges,local areas,moderate -Fibroadenoma -Acinaratrophy,4ocal,mild -Adencea The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Ovary, Trachea,Thyroid,ParithyroidE,sophagus, Lymph Node (sesenteric)S,alivaryGland,Eye. ----------------------------------------------------------------------- -- - ------ Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 145 336 SummarizedSingleTabulatedAnimalReport (continued)IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N Ffi-3924T:oo YearOral Toxicity-OncogeniciSttyudyin Rats --- - --- --------------------AnisalNumber: IR-4794 Sex: Female Group: Fate: (Weekz105)TerminalSacrifice - - ------2) FN-3924 100 ppe Table:2 MacroscopicObservations: Pituitary MicroscopicObservations: Kidney Liver Parathyraid Pituitary Uterus -Hemorrhagicmass,0.3 co dia. -Pelvicmineralizationm,arked -Hepatocytevacuolations,ultifocal,mild Cystaiddegenerationl,ocalareas,sild Nep&tDcytealteration,vacuclated,sultifocal, mild Negalocytosis,moderate Repatocytaelterationb,asophilicf,ocal, mild -Not examined,not in plantof section -Adenosa -Cystic glands,marked The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Heart,Lung,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,Ovary,MammaryGland,Trachea,Adrenal,Thyroid,Esophagus, LymphMode (sesenteric)P,ancreas,Salivary61and,Eye. -------------------------------- --- -- -- Animal Number: IR-4795 Sex: Female Group: 2) W3924 100 ppe Fite: (Weeka105)TerminalSacrifice MicroscopicObservations: Liver Rissary61and MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Mammary Gland ---------- -Raisedpale mass,2 ce,dia.,in leftlateral lobe. -Necrotic,inflassedsilk cysts,neck and perineilareas;miss,3 1 2 cg, inguinalarea. -Corticavlacualitionf,ocal,mild Sinusaidalectasia,cortex,mild -Not examined,missing -Pelvicsineralizatiosni,ld -Portalbileductproliferatiosni,ld Regalocytosiss,ild Nepatocellularadenama -Vascularmineralizationm,ild Alveolarmacrophiges,local areas,moderate Newrhage, localareastmild -Adenocarcinna,cystic Adenocarcinosa Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 146 337 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3924:Two Year Oral Toxicity-OneogeniciSttyudyin Rats ---- --- -----------AnimalNumber: IR-4795 Sex: Female Group: Fate: (Meek=105)TerminalSacrifice 2) FN-3924 100 ppe Table: 2 MicroscopicObservations(continued): Ovary Spleen Uterus -Cyst,follicular -Notosiderosis,moderate -Cysticglands,sild The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bane Narrow,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Pituitary,Trachea,Thyroid,ParathyroidL,ymphNode (sesenteric), Pancreas,SalivaryGland,Eye. - ------------------------------ Animal Number: IR-4796 Sex: Female Group: 21 Fli-3924100 ppe Fite: (Week=105)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung -No visiblelesions. -PelvicBiwalization,minimal -Hepatocytevacualationo,ultifocalm,oderate "lkytesis, moderate -Vascularmineralizationm,ild Perivasculasronanuclearinfiltratem,ild The followingtissues*ere foundto be withinnormallimits: Brain,SpinilCard,Bone Marro*,Spleen,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Ovary,MammaryGland,Pituitary,Trachea,Adrenal,Thyroid, Parithyraid,Esophagus,LymphNode toesenteric)P,ancreas,SalivaryGland,Eye. ------------------------------- Animal Number: IR-4797 SeK: Female Broup: 2) Ffl-3924100ppe Fate: (Week=105)TerminalSacrifice MacroscopicObservitims: Liver MicroscopicObservations: Adrenal Kidney Liver Lung LymphNode (sesenteric) Pituitary Thyroid -- -------------- -Appearspale and mottled. -Sinusaidaelctisia,cortex,moderate -Pelvicmineralizationm,inimal -Repitacytevacuclationd,iffuse,moderate Negalocytosis,marked -Vascularmineralizations,ild Perivasculamrmanuclearinfiltrates,ild -Polyarteritism,oderate -Adencea -HyperplasiaC,cell,focal,mild - --- ---- Species:Rat ProjtctNumber: 0291CROO12 Summarized STAR Page: 147- 338 SummarizedSingleTabulitedAnisalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral 7o%icity-OncogenicityStudy in Rats ---------------------AnisilNumber: IR-4797 Six: Female Broup: Fate: (Meek=105) TerminalSacrifice 2) FN-3924 100 pps Table: 2 MicroscopicObservitiont(continued): The followingtissueswere found to be vithinnormallimits: Brain,SpinalCard, lone Narrow,Spleen,Heart,Stomach,SmallIntestine,Large Intestine, Urinary Bladder,Aorta, Uterus, Ovary, Mammary Bland, Trachea,Pirathyroid,Esophagus,Pancreas, SalivaryBland, Eye. --- --- --- ---------------- Animal Number: IR-4798 Sez: Fesile Group: 2) FN-3924 100 ppe Fate: (Week=105) TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Liver Lung Lymph Node (sesenteric) Nass,iryBland Parathyroid Small Intestine -No visiblelesions. -Portalsononucleatrell infiltrates,ild Portalbile duct proliferations,ild Hepatocytovacuolition,oultifocal,mild Negalocytosis,moderate -Vascularmineralizations,ild Alvealor.&Kropbageslfecal,mild Perivascular@iononucloianrfiltrate,mild Hemorrhage,Ulti#Kalm,ild -Hemorrhage, moderate -Not examined,missing -Not examined,not in plane of section -Ulcer The followingtissueswere found to be withinnormallimits: Brain, Spinal Card, Bone Karrov,Spleen,Kidney,Heart, Stomach,Large Intestine, Urinary Bladder,Aorta, Uterus,Ovary,Pituitary,Trachea,Adrenal,Thyroid,Esophagus, Pancreas,SalivaryBland, Eye. ----------------- - - ---------------- Animal Number: IR-4799 Six: Female group: 21 FN-3924 100 ppe Fite: (Meek= 70) Sacrificedin extresis Macroscopic Observations: Pituitary Microscopic Observations: Adrenal Kidney Liver Lung --- ------- - ----------------- - -Enlarged,0.8 ce dia. -Corticalvacuolation4,ocal,sild -Pelvic mineralizationm,inimal -Hepatocytevacuolation,periportal,moderate hgalocytosis,mild -Hemorrhage,oultifocallsild Perivisculasronanuclearinfiltrates,ild Species:Rat Project Number: OnICROO12 Susarized STAR Page: 148 339 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FN-3924:Too Yeir OralToxicity-OncogeniciSttyudy in Rats Table:2 Animal Number: IR-4799 Sex: Feeale Broup: 2) FO-3924 100 ppe Fate:(#eeks 70) Sacrificeidn eitremis MicroscopicObservations(continued): LymphNode (sesenteric) Parithyroid Pituitary SalivaryBland UrinaryBladder -Not examined,missing -Not examined,not in planeof section -Adenama -Not examined,missing -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Splm, Heart,Stomach,BeallIntestine,LargeIntestine, Aorta, Uterus,Ovary, MammaryGland,Trachea, Thyroid,Esophagus,Pancreas,Eye. -------------------------- -------- Animal Number: IR-4800 Sex: Fesale Broup: 2) FN-3924100 pps Fate:(kekz 105)TerminalSacrifice MacroscopicObservations: Skin Himeary Gland Nicroscapic,Dbservations: Adrenal Kidney Liver Lung MassiryGland Ovary Pirithyraid Pituitary -Hair lossm abdomen. -Kassin rightaxilla,I ce dia.;missin left axillii3,x 2 ce. -Sinusaidailttasia,cortex,unilateral, marked -Chronicprogressivneephropithys,ild Pelvicmineralizationm,ild Hyperplasiap,elvicepitheliums,ild -Regalocytosism,ild -Pneumoniai,nterstitialc,hronic,oultifocal, sild -Adenocarcinosa Adenocarcinoma -Tubularhyperplasiab,ilateral,moderate -Not examined,not in planeof section -Adenosa The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Trachea,Thyroid,Esophagus,LymphNode toesenteric)P,ancreas, SalivaryBland,Eye. -- ------------- ---- - -- -- ----------------------------------- Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 149 340 SummarizedSingleTabulatedAnimalReport lcantinued) IndividualNacroscapicand MicroscopicObservations RikerLaboratoriesI,nc. 3N Ffl-3924T:wo YearOral Toxicity-OncogeniciSttyudyin Rats --- - -------------------------- -Animal Number: IR-4801 Sex: Female Group: Fite:tweekz 94)Sacrificeidn extresis - -- -- 2) FN-3924 100 ppe Table:2 MicroscopicObservations: Pituitary MicroscopicObservations: Liver Lung LymphNode (sesenteric) Pituitary -Raisedred mass,I ce dia. -Nepatocytevicualation,localareas,moderate Negalocytosism,ild -Yascularmineralizations,ild Alveolarmacrophages,localareas,moderate Hemorrhage,oultifocal,mild -Not examined,missing -Adencia The followingtissueswerefoundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Spleen,Kidney,Heart,Stomach,SmallIntestine, Large Intestine,UrinaryBladder,Aorta,Uterus,Ovary,Mammarygland,Trachea,Adrenal, Thyroid,Parathyroid,Esophagus,Pancreas,SalivaryBlind,Eye. ------------------------------------- ------------- Animal Number: IR-4802 Sex: Female Group: 2) FN-3924 100 ppe Fate:(Week=105)TerminalSacrifice MacroscopicObservations: Pituitary Liver MicroscopicObservations: Adrenal Eye Kifiney Liver Lung Mammary Gland Pituitary Spleen Uterus -@Hewrhagicmass, 0.7 ce dia. -laisedpalecircularlesion,0.7 ce dia.,in medianlobe;'.-oultirpaliesed palelesions0,.5- I ce,in leftlateral lobe.- -Sinusoidaelctasia,cortex,mild -Retinalatrophy,oultifocals,ild -Pelvicmineralizationm,ild -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hepatocytevacualationo,ultifocal,mild Negalocytosis,mild HepatDcellularadencea Nepatocellularadenoma -Yascularmineralizations,ild Perivasculasrononucleairnfiltratem,ild -Galactocele -Adenoma -Hesosiderosis,moderate -Cysticglands,moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,BoneNarrow,Heart,Stomach,SmallIntestine,LargeIntestine, ------------------ Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 150 341 Smarized SingleTabulatedAniul Report(continuediIndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-4602 Sex: Female Group:( 2) FN-3924100 ppe Fate: (Week=105)TerminalSacrifice MicroscopicObservations(continued): Thefollowingtissueswerefoundto be withinnormallimits(continued): UrinaryBladder,Aorta,Ovary,Trachea,Thyroid,Parathyraid,Esophagus, LymphNode (mesenteric)P,ancreas,SalivaryBland. --------------------------------------- Animal Number: IR-4903 Sex: Female Group: 21 FN-3924 100 ppe Fite: (Weeks105)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Kidney Liver Lung oviry Uterus -No visiblelesions. -Sinusaidaelctasia,cortex,minimal -Chronicprogressivenephropathy,minimal -Nepatacytveacuolationo,ultifocal,mild Cystaiddegenerationo,ultifocalm,ild Hipatocytealterationv,icuclatedf,ocal, sild Negalocytosiss,ild -Pntuotia,interstitiaclh,ronic,localareas, sild Alveolarsacrophageso,ultifocal,mild Perivasculamronucleir infiltrates,ild -Tubularhyperplasiab,ilateral,mild -Cysticglands,mild The follovingtissueswerefoundto be Nithinnormallimits: Brain,SpinalCard,Bane Narrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,HasaaryBlind,Pituitary,Trachea,Thyroid,PirathyraidE,sophagus, LymphMode (sesenteric)P,ancreas,SalivaryGland,Eye. -------------------------- - --- ----------- --------- Animal Number: IR-4904 Sex: Female Group: 2) FN-3924 100 ppe Fate: (Week=105)TerminalSacrifice MacroscopicObservations: SoftTissues(leg) Pituitary Liver MicroscopicObservations: Adrenal ------------------ -Lefthind foot swollen. -Hemorrhagicmass, 0.8 ca dia. -Multiplpealefociin all lobes!largepale mass,4 1 3 s 2 es,in left laterallobe. -Sinusoidaelctasia,cortex,unilateral, marked --- --- ------- Species:Rat Project Number: 0291CROO12 Sumovized STAR Page: 151 342 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too Year Oral Toxicity-UncogenicitSytudy in Rats Table: 2 Animal Number: IR-4804 Six: Female Group: 2) FN-3924 100 ppo Fate: (Weeka105) TerminalSacrifice MicroscopicObservationslcontinued): Done Kidney Liver Lung Pituitary Spleen Uterus -kthritis,synovitisj;oints,hindleg, unilateral,moderate -Chronic progressivenephrt)pathym,inimal Pelvicmineralizations,ild Pigment,cmv. tub. epithelium,brown,sild -Portalsonmuclearcell infiltrates,ild Portalbile duct proliferations,ild Nepatocytevacualation,oultifocal,mild Regalacytosis,sild Repatocellularcarcinoma Regatopoiesis,extraeedullarys,ild -Yascularmineralizationm,ild Perivascularmanonuclearinfiltrate,mild Hemorrhage,local areas, moderate -Adenosa -Hemosiderosis,mild -Cystic glands, moderate The followingtissueswere foundto be withinnormal lisitt: Brain, Spinal Cord,Bone Narrow,Heart, Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta, Oviry, RamearyGland, Trachea,Thyroid,Parathyroid,Esophagus, Lymph Node (sesenteric),Pancreas,SalivaryGland,Eye. ---------------- --- --- ------------ - ------ --- ---- --------------------- Animal Number: JR-4805 Sex: Female Group: 2) FM-3924 100 ppe Fite: (Week= 87) Found Dead Microscopic Observations: Pituitary Liver MicroscopicObservations: Eye Kidney Liver Lung Lyso Node (sesenteric) Ovary Parithyroid -- --- --- ---------------------------- -Hemorrhagic mass, 1.2 x 0.7 ce. -Palo -Not examined,missing -Pelvicmineralization,minimal Yacualition,conv. tub. epitheium,moderate -*atdcyte vacuolation,periportal,moderate Negalocytosis,sild -Yascularmineralizationm,ild Alveolar eacrophages,moderate Nm rrhage,localareas,aild -Not examined, missing -Tubularhyperplasia,bilateral,mild -Nottiasinedn,otin plantof uction species: Rat Project Number: 0221CROO12 Smarized STAR Page: 152 343 SummarizedSingleTabulatedAnimalReport (continued) IndividualKacroscopicand KicroscapicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats --- ---------------Animal Number: IR-4905 Ba: Female Broup: Fate: (Weekx 67) FoundDead 2) FK-3924100 ppe Table:2 MicroscopicObservations(continued): Pituitary SmallIntestine Spleen UrinaryBladder Uterus -AdenD@a -Withinnormallimits Fewer than protocolnumber -Hisoriderosism,arked -Not examined,missing -Exudate,lumenal,moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Karroo,Stomach,Large Intestine,Aorta, MammarySland,Trachea, Adrenal,Thyroid,Esophagus,Pancreas,Salivarygland,Heart. Animal Number: IR-4807 Sex: Female Broup: 2) Ffl-3924100 pps Fate:(Week= 79)Sacrificedin extresis MicroscopicObservations: Skin Liver MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Mammary Bland Parathyroid Spleen Thyroid Trachea -Ulceratednecroticmass,5 1 3.5 x 2 cm, rightaxilla. -Smallp.alelesion,0.4 ce dia.,right anteriorlobe. -Sinasoidalectasia,cortex,moderate -Not examined,missing . -Pelvicmintralizitionm,inimal -Regalacytosiss,ild Hyperplasticnodule -Vascularmineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, vild Alveolareacrophageso,ultifocals,ild -Adenocarcinaead,uctal -Not examined,missing -Hematopoiesise,xtrasedulliryi,ncreased, moderate -Mt exaeined,missing -Not examined,missing The followingtissueswe foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Ovary,Pituitary,LymphNode (sesenteric)P,ancreas, SalivaryGland,Eye. -- ---------------- - -------- -- -- - -- - Species:Rat Project Number: 0291CROO12 Summarized STAR Page: 153 344 SummarizedSingleTabulatedAnimalReport (continued).IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncoQenicitSytudy in Rats Table:2 AnimalNumber: IR-4808 Sex: Female Group: 2) FN-3924 100 pps Fate: (Week=105) TerminalSacrifice MicroscopicObservations: Pituitary Mammary Gland MicroscopicObservations: Aorta Kitney Liver Lung LymphNode (sesenteric) Mammary Gland Ovary Pituitary UrinaryBladder Uterus -Raisedhemorrhagicmass, I ce dia. -Modularmass,4 1 2 ce, leftside. -Not examined,missing -Chronicprogressivenephrepathy,mild Pelvicmineralizationm,arked -Portalsononucleacrell infiltratem,ild Portalbileductproliferationm,ild Hepatacytovacualation,diffuse,moderate Hipatacytealterationv,acualated,focal, mild Negalocytosism,ild -Yasculirmineralizatiosni,ld Hemorrhage,local areas,moderate -Not examined,missing -Lobularhyperplasia -Tubularhyperplasiab,ilaterals,ild -Adenosa -Epttheliahlyperplisias,imple,focal,eild -Cysticglands,moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Heart,Stomach,Small Intestine,LargeIntestine, Trachei,Adrenal,Thyroid,Parathyraid,Esophagus,Pancreas,SalivaryBland,Eye. ----------------------------------- ---- ---- --- -- ---------- -- ---------------------- Animal Number: IR-4809 Set: Female Group: 2) FN-3924 100 ppe Fate: tweekz105)TerminalSacrifice MacroscopicObservations: Liver Mammary Gland MicroscopicObservations: Adrenal Kidney Liver --- --- -- -- -Severalpalelesionsin alllobes. -Nodularmass,5.5 x 5 x 2 ce, throatire&; nodularmass,6.5 x 5.5 x 2.5 ca, leftinguinalarea. -Sinusaidalectasia,cortex,marked -Chronicprogressivenephropathy,mild Pelvicmineralizationm,inimal -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild NegalDcytosis, moderate Hopatocellular idenami Hyperplasticnodule, multiple Vacuolitionof hepitocytes in same nodules. Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 154 SummarizedSingleTabulatedAnimalReport (continutd) IndividualMacroscopicand MicroscopicObwvations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncooeniciSttyudyin Rats ------------------Animal Number: IR-4809 Six:Female Group: Fate: (Neekz105)TerminalSacrifice 2) FN-3q24 100 pps Table:2 MicroscopicObservationstcontinued): Lung HassiryGland Ovary Pituitary Uterus -Alveolareacrophageso,ultifocals,ild Perivasculasrononucloairnfiltrates,ild -Fibroadenomi Largeareasof necrosisin tumor. -Tubularhyperplasiab,ilaterals,ild -Adenoma -Cysticglands,moderate The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Narrow,Spleen,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,Trachea,Thyroid,Parathyraid,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryBlind,Eye. - -- -------------- - - --- --- --- ------------------- Animal Number: IR-4810 Set: Female Group: 2) FN-3924 100 ppa Fite: (Meek=105)TerminalSacrifice MicroscopicObservations: .Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Lymph Node (mesenteric) Parathyroid Pituitary -Raiseddirk&ass,0.8 ca dia. -Sinusaidaelctasia,cortex,moderate -Chronicprogressivenephropathy,minimal Pelvicmineralizationm,inimal -Portalsononucloacrellinfiltratem,inimal Repitocytveicuclationo,ultifocals,ild higalacytosism,arked -Yascularmineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, sild Hemorrhage,local areas,mild -Not examined,missing -Sinusaidalectasia,moderate -Adenosa The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Done Karroo,Spleen,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,Uterus,Ovary,KassaryGland,Trachea,Thyroid,Esophagus,Pancreas, SalivaryGland,Eye. ------------ -- - ---------------------- species:Rat Project Number: 0281CROO12 Summarized STAR Page: 155 346 SummarizSeidnglTeabulatAendimaRleport(continued) IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3H FN-3924T:woYearOralToxicity-beopmicSittuydyinRats ---- --- -- -- -----AnisalNumber: IR-4811 Sex: Female Broup: 2) Ffl-3924100ppe Fate: (Weeke105)TerminalSacrifice Table:2 MicroscopicObservations: Eye Liver MicroscopicObservations: Adrenal Esophagus Eye Kidney Liver Lung Dvary spleen Uterus -opacity,lefteye. -Paleand mottled. -Sinusoidaelctasia,cortex,sild Medullarycellhyperplasiiu,nilateralm,ild Pheochromacytoma,benign,unilateral -Not examined,missing -Retinalatrophy,unilateralm,oderate Cataract,unilateral -Chronicprogressivenephropathy,sild Pelvicsintralizationm,oderate -Portalsonanucleacrellinfiltratem,ild Portalbileductproliferationm,ild Hepatocytevacuolitionp,eripartalm,oderate %&IKYtOSiS, moderate Pigment,brown,hepatocytes,sild -Yascularmineralizitionm,ild -Tubular-adeno4au,nilateral. @-Hosasiderosism,ild -Cysticglands,mild The followingtissuesvere foundto be withinnormallimits: Brain,SpinalCord,Bone Rarrom,Heart,Stomach,SmallIntestine,LargeIntestine, UrinaryBladder,Aorta,MammaryBland,Pituitary,Trachei,Thyroid,Parathyroid,Pancreas, SalivaryGland,LymphNode (sesenteric). ------------ - --- --------------------- Animal Number: IR-4812 Sex: Female Group: 2) FN-3924 100 ppe Fite: (Week-1-05)TerminalSacrifice MacroscopicObservations: Skin Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Ovary Parathyroid -Kiirloss,headto neck. -Raisedhemorrhagic&ass,I ce dia. -Sinusaidalectasia,cortex,mild -Pelvicmineralization,minimal -kpitOCyte VaCUOIAtiOn, BUItifKal, mild NglalKYtOSiS, moderate -Yascularaineralization,mild Alveolar@Krophages, local areas,sild -Tubularhyperplasia,unilateral,aild -Not examined,not in plane o4 section Species:Rat Project Number: 0281CM012 Summarized STAR Page: 156 347 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-NcoginicitSytudyin Rats --- ---------AnisilNumber:IR-4812 Six:Female Group: C 2) FN-3924100 ppe Fate: (Week-105)TerminalSacrifice Table:2 MicroscopiOcbservations(continued): Pituitary Spleen Uterus -Adenoma -Hemosiderosis,moderate -Cysticglands,minimal The folloning'tissuweesre foundto be withinnormallimits: Brain,SpinalCord,DoneNarrow,Heart,Stomach,Small Intestine,LargeIntestine, UrinaryBladder,Aorta,MassiryBland,Trachea,Thyroid,Esophagus,LymphNode (sesenteric), Pancreas,SalivaryGland,Eye, Skin. -------------------------------------Anisal Number:IR-4813 Six: Female Group: 2) Fil-3921400 ppe Fate: lweekz105) TerminalSacrifice MicroscopicObservations: Liver MicroscopicObservations: Adrenal Eye Liver Lung Ovary Parathyroid Pituitary Spleen -Paleand mottled. -Corticavlacuolitionl,ocalareas,sild -Retinalatrophy,marked -Portalsononucleacrellinfiltratet,ild Portalbileductproliferationm,ild Hepatocytveicuolations,ultifocalm,ild Hepatocytealterationv,acuolatedo,ultifK&I, mild Regilacytosism,ild -Yasculasrintrilizatiosni,ld -Tubularadenoma,unilateral -Not examined,not in planeof section -Adencei -Hetasiderasism,ild The followingtissueswere foundto be withinnormallimits: Brain,SpinalCard,Bone Harro*,Kidney,Heart,Stomach,SmallIntestineL,arge Intestine, UrinaryBladder,Aorta,Uterus,Himary Gland,Trachea,Thyroid,Esophagus, LymphNode (sesenteric)P,ancreas,SalivaryBland. ---- --------------------- - - ---- ------------- --------- ------------------ Anisal Number: IR-4814 Sex: Female Group:( 2) FK-3924100 ppe Fate: (Neekm105)TerminalSacrifice MicroscopicObservations: -No visiblelesions. MicroscopicObservations., Adrenal -Sinuscidaelctisia,cortex,sild -- - ----------- ---- - ------------------- Species:Rat Project Number: 0211CROO12 Sumarized STAR Page: 157- 348 SusaarizedSingleTabulatedAnimalReportttontinued) IndividualMacroscopicand MicroscopicCbwvations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-WcogenicityStudy in Rats Table: 2 Animal Number: IR-4914 Sex: Female Group: 2) FN-3924 100 ppe Fate: (Neekz105) TerminalSacrifice MicroscopicObservations(continued): Kidney Liver Lung Parathyroid Pituitary SalivaryGland Spleen Thyroid -Chronic progressivenephropathy,mild Pelvicmineralizations,ild -Portalsononuclearcell infiltrate,mild Portalbile ductproliferationm,inimal Hipatocytevamulationg oultifocal,mild N"alKytosis, mild -Vascularmineralizations,ild Pneumonia,interstitialc,hronic,gultifocal, mild Alveolar macrophages,local areas, moderate -Not examined,not in plane of section -Ad"ova -Not examined, missing -Rabosiderasis,mild -Not examined,not in plane of section The followingtissueswere found to be within normallimits: Brain, Spinal Cord,Bone Narrow,Heart, Stomach,Small Intestine,Large Intestine, UrinaryBladder,Aorta, Uterus,Ovary,Nas"ry Sland, Trachea,Esophagus, Lymph Node (sesenteric),Pancreas,Eye. ---- -- -- ----- --------- Animal Number: IR-4615 Sex:Fmle Group: 2) FN-3924 100 ppe Fate: (Veekz105) TerminalSacrifice MacroscopicObservations: Adrenal Uterus Microscopic Observations: Adrenal Heart Kidney Liver Lung -Left adrenalenlarged. -Cysticlesion,1.5 ce dia.,lefthorn. -Sinusoidalectasia,cortex,unilateral, marked Corticalatrophy,unilaterjklm,oderate -Hyacarditis,chronicnonsuppurative, oultifocal,minimal -Chronic progressivenephropathy,moderate Pelvicmineralizationm,ild Polyarteritisc,ortical,moderate -Portalmanonuclearcell infiltrate,minimal *AtOCytt VACUOlatiOn,@UltifKAI, Mild Negalocytesis,minimal -Vascularmineralizations,ild Alveolareacrophages,sultifocal,sild PerivaKularamonucler in4iltrates,ild Species: Rat Project Number: ONICROO12 Summarized STU Pago: 158 349 SummarizedSingleTabulatedAnimalReport ltontinuedlIndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-4815 Sez: Female Group: 2) FN-3924100 ppe Fate: (Week=105) TerminalSacrifice MicroscopicObservations(continued): LymphNode (sesenteric) Ovary Pancreas Pituitary Uterus -Polyarteritissi,ld -Tubularhyperplasi&b,ilateral,moderate -kinar atrophys,ild -Pigment,brown,pars distalis,moderate -Polyp The followingtissuesmere foundto be withinnormallimits: Brain,SpinalCard,BoneNarrow,Spleen,Stomach,SmallIntestine,Large Intestine, UriniryBladder,Aorta,MammaryGland,Trachea,Thyroid,P&rathyroid,Esophagus,SalivaryGland, Eye. --------------------- --- --- -- ----- --- Animal Number: IR-4817 Sex: Female Group: 1 2) FN-3924100 ppe Fite: (Weeks105)TerminalSacrifice MacroscopicObservations: Skin Pituitary Liver MicroscopicObservations: Adrenal Heart Kidney Liver Lung LymphNode (sesenteric) Mammary Gland Ovary Parathyroid Pituitary Skin -Raisedulceratedlesion,liftrearfoutpad. -Raisedmass,0.7 citdia. -Paleriisticdircularmass,2 ce dia.,median lobe. -Corticalvacuolationljocalareas,mild Pigm t, brown,cortical,sild -Nyocarditisc,hronicnonsuppurative, oultifocalm,inimal -Chronicprogressivenophropathys,ild Pelvicmineralizationm,oderate -Portalmanonucleacrellinfiltratem,ild Portalbileductproliferatiosni,ld Nepatocytevicuolationgdiffuse,marked Cystoiddegenerationf,ocal,sild Nepatocellularcarcinoma -Yiisculimrineralizationm,ild Perivasculasrononucloairnfiltrates,ild -Not exagin", missing -6&IACtKIle -Cyst,bilateral -Adenosa -4Wenosa -Pododermatitisu,lcerative,hindleg,marked The followingtissueswere foundto be withinnormallimits: Brain,SpinilCord,Boe Narrow,Splm, Stomach,SmallIntestine,LargeIntestine, Species:Rit Project Nubirl.-0201CROO12 &mirized STAR Page: 159 350 SummarizedSingleTabulatedAnimalReport fcantinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N rN-3924:Two Year OralToxicity-OncogeniciSttyudy in Rats Table:2 Anisal Number: IR-4817 Sax: Female Broup:( 2) Ffl-3521400 ppe Fate: (Veekx105)TerminalSacrifice MicroscopicObservations(continued): Thefollovingtissues*erefoundto be mithinnormallimits(continued): L)rinarByladder,Aorta,Uterus,Trachea,Thyroid,Esophagus,Pancreas,Salivarygland,Eye. - --------- AnisalNuabor: IR-4818 Sex: Female Group: 2) Fit-3924100 pps Fate: (Week@104)Sacrificedin extresis MacroscopicObservations: Pituitary Adrenal Kidney MicroscopicObservations: 'Adrenal Kidney Liver Lang Ovary Parithyroid Pituitary Spleen Stomach Thyroid Uterus -Raisedmass,0.8 ce dia. -Rightadrenalappearsenlarged. -Pale,pittedand enlarged. -Corticalvacuolationmjoderate SiousoidalKtasia, cortex,moderate Corticalatrophy,unilateral,moderate -Chronicprogressivenephropathy,marked Pelvicmineralizationm,inimal -&p&tKyto vacuolatim,diffuse,minimal -Vascularmineralizationm,ild Alveolarucrophages,focal,minimal Perivisculamrmonuclearinfiltratem,inimal -Tubularhyperplasiab,ilateral,mild -Notexamined,not in planeof section -Adenosa -Hemosiderosiss,ild -Gastritis,acute,moderate -HyperplasiaC, cell, localareas,moderate C cell carcinoma -Cysticglands,moderate The 4ollamingtissuesvere foundto be Nithinnormallimits: Brain,SpinalCord,BoneHarrom,Heart,Small Intestine,LargeIntestine,UrinaryBladder, Aorta,Mammary61and,Trachea,Esophagus,Lymph Node (sesenteric),Pancreas,Salivary61and,Eye. --- --- ---------------------- Animal Number: IR-4819 Six:Female Group: 2) FN-3924 100 ppe Fate: (Weekz105)TerminalSacrifice MacroscopicObservations: Pituitary Naawy Gland Liver -Darklesion,0.3ce dia. -Lobularmass,3 K 1.5x I ce, leftinguinal area. -Palecircularlesion,1.4ce dia.,udian lobe. Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 160 351 SummarizedSingleTabulatedAnisilReport (continued) IndividualMicroscopicand MicroscopicObservitiont RikerLaboratoriesI,nc. 3M FN-3924:Two Year OralToxicity-OnciigenicSituydyin Rats -- ------ -- ------------------------ ---AnimalNumber: IR-4019 Sex: Female Group: 2) FN-3924 100 ppe Fate: (Meek=105) TerminalSacrifice Table:2 MicroscopicObservations(continued): Adrenal Heart Kidney Liver Lung Maseary gland Ovary Parathyraid Pituitary Thyroid Uterus -Corticalvacuolationl,ocalareas,aild Sinuroidalectisia,cortex,mild -Myocardiaflibrosis,localareas,moderate -Pelvicmineralizationm,inimal -Portalsononucleacrellinfiltratem,ild Portalbileductproli4erations,ild Regalocytosis,moderate Hyperplasticnodule -Perivisculasrononucleairnfiltrates,ild -Adenocarcinoma -Tubularadenoma,bilateral -Not examined,not in planeof section -Adenm -C callcarcinoma -Cysticglinds The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Spleen,Stomach,SmallIntestine,Large Intestine, UrinaryBladder,Aorta,TrachealEsophagus,Lymphkdo (sesenteric)P,ancreas,SalivaryBlind, Eye. ---------- --------- ----------Animal Number: IR-4620 Sex: Female Broup: Fate: (Weekz 80) FoundDead 2) FN-3924 100 ppe MacroscopicObservations: Skin Liver Stomach MicroscopicObservations: Adrenal Aorta Eye Heart Kidney Large Intestine Liver -Largeulcerated*ass,8 s 4.5 x 5 ce, surroundinlgefthind log. -Nottled,enlarged -Fullof blackishy,ellowishfluid. -Malignantlysphoma,histiocytic -Not isimined,missing -Not examined,missing -Malignantlymphoma,histiocytic -Pelvicmineralizationw,ild Malignantlymphosa,histiocytic Proteinresorptiondroplets,moderate -Not examined,missing -Malignantlymphoma,histiocytic Extensivenodularand diffuseproliferation with vascularinvolvement. Species:Rat Project Number: 0281CRO12 Summarized STAR Page: 161 352 Sumarized SingleTabulatedAnisalReport (continued@IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two year Oral7oxicity-OncogenicitSytudyin Rats Table:2 Animil Number:IR-4920 Six:Female 6roup: 2) FN-3924 100 ppe Fate: (Neeka 00) FoundDead MicroscopicObservations(cmtinued): Lung LymphNode (sesentiric) Hassary Gland Pancreas StallIntestine SoftTissues(leg) Spleen Stomach UrinaryBladder -Vascularminwalization,mild Malignantlyaphola,histiocytic -Not examined,missing -Not examined,missing -Not examined,missing -Not examined,missing -Malignantlygphosa,histiocytic Miss involvinghindlegwas malignant lymphosa;necroticand ulcerated. -Hemosiderosis,moderate -Necrosis,sucosal,localareas,moderate -Not examined,missing The followingtissueswere foundto be withinnormallimits: Brain,SpinalCord,Bone Narrow,Uterus,Ovary,Pituitary,Trachea,Thyroid,Parithyroid, Esophagus,SalivaryBland. - -- ------------------- Species:Rat ProjectNumber: 0291MO12 Summarized STAR Page: 162 '4 r, 7k Pothol"y aridlbxlcology RikerLaborstorWo. Inc. Building270-3S-05,3M Center St.Paul,Minnesota 55144-1000 TWO YEAR ORAL (DIET) TOXICITY CARCINOGENICITY STUDY OF FLUOROCHEMICAL FM-3924 IN RATS (RIKER Experiment No. 0281CROO12) Conducted During April, 1981 May, 1983 Volume 2 of 5 RIKER Laboratories, Inc. / 3M Company St. Paul, Minnesota 55144-1000 U.S.A. SummarizedSingle TabulatedAnimal Report IndividualMacroscopiacnd Microscopicbwvations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral 7oxicity-WcoginicitSytudyin Rats ---- -------Animal Number: IR-3761 Sex: gale Group: Fate: (Reek-106)TerminalSacrifice 3) FN-3924 30 ppe Table:2 MicroscopicObservations: Skin Pituitary Kidney MicroscopicObservations: Adrenal Esophagus Liver Pancreas Parathyroid Pituitary SalivaryGland Skin Thyroid Trachea -Raisedcircularlesions,both hind feet. -Smallraiseddark area. -Paloarea,one end of right kidney. -Corticalvacuolatim,localareas,mild -Not examined,aissing -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild -Acinaratrophy,mild -Not exaginw, missing -Adencea -Not examined,missing -Pododereatitiusl,cerativeb,ilateral,marked -Not examined,missing -Cyst,subsucosal The followingtissueswere foundto be withinnormallimits: Spleen,Kidney,Heart,Lung,Testis/EpididysisP,rostate,Stomach,UrinaryBladder. --- ------------------------ -------- Animal Nuaber: IR-3762 Sex:Halt Group: 3) M3924 30 pps Fite: (Yeekz106)TerminalSacrifice MacroscopicObservations: Skin MicroscopicObservations: Heart Liver Lung Pituitary PreputialGland Prostate Spleen -Inflassedlesion,I ce dia.,apparently healing,scratalarea. -*yocarditisc,hronicnonsuppurative, sultifocals,ild -Portalamonucloarcellinfiltratem,inimal Hopatocytevacaclationo,ultifocal,mild -Yascularmineralizations,ild -Adenosa -fteputiaaldenitis,acute,moderate -Prostatitisa,cute,moderate -Hmsidorosis, minimal The followingtissues*ere foundto be withinnormallimits: Kidney,Testis/EpididysisS,tomach,UrinaryBladder,Adrenal,Thyroid,Parathyroid,Trachea, Esophagus,Salivary Sland, Pancreas. --- -------- --- ---- - ------------------------ Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 163 354 Summizod SingleTabulatedAnimalReporttcantinved) IndividualMacroscopicand MicroscopicObservations RikerLaborstoriesIgnc. 3K FN-3924:Two YearOral Tozicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3763 Sex: Nale Group: 1 3) FN-392430 pps Fate:(Nffk2106)TerminalSacrifice MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Heart Kidney Liver Lung Pancreas Parathyroid Pituitary Thyroid Trachei -Smalldark area. -Pheochrosocytomab,enign,unilateral -flyocarditicsh,ronicnonsuppurative, oultifocalslild -Chronicprogressivenephropathy,moderate -Portalsononscleacrillinfiltrates,ild Nepatocytvoacuolitiono,ultifkal,mild -Vascularsineralizationm,ild Perivisculasrononacleairnfiltrates,ild -Acinaratrophy,moderate -Notexamined,not in planeof section -Adonoma -Ultimcbranchiaclyst -Tracheitisc,hronic,mild The followingtissueswere foundto be withinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Esophagus,SalivaryBlind. ------------ - -------- ----- Animal Number: IR-3764 Sex: Male Group: 3)'M-3924 30 ppe Fate: (Week-1-06)TerminalSacrifice MacroscopicObservations: Skin -Circular aisedlesions,rightand lefthind footpads. Pituitary Thymus MicroscopicObservations: Adrenal -Smalldark area. -Possiblyenlarged -Sinusaidaelctasia,cortex,localareas,sild Medullarycellhyperplasiao,ultifocals,ild Heart -Myocarditisc,hronicnonsuppurative, Liver oultifocals,ild -Portalmononacleacrellinfiltrates,ild Portalbileductproliferatiosni,ld Regalocytosiss,ild Lung -Vasculasrintralizatimm,ild Pneumonia,interstitialc,hronic,oultifocal, sild Perivasculamrnanuclearinfiltrate,minimal HyperplasiaS,"tal Cell,fk&lo sild Parithyroid -Notexaminedgnot in planeof section - -- -- -- --- --------------- -- ---- - Species:Rat Project Number: OnICROO12 Sm arized STAR Page: 164 355 Sumarized SingleTabulatedAnimalReport(continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3764 Sex:Halt Group: 3) FN-392430 ppe Fate: I#mkz 106)TerminalSacrifice MicroscopiOcbservations(continued): Pituitary Prostate Skin Thymus Thyroid -Adenosa -Prostatitisa,cute,moderate -Pododereatitiusl,ceriti",bilateralm,arked -Not examined,not in plantof section Sectionof vesseland adiposetissut. -HyperplasiaC,cell,focal,mild Ultimobranchiaclyst The followingtissueswere foundto be withinnormallimits: Spleen,Kidney,7estis/EpididysisS,tomach,UrinaryBladder,Trachea,Esophagus,SalivaryGland,, Pancreas. --- -------------------------------- AnisalNuaber:IR-3765 Sex:Halt Group: 1 3) FN-392430 pps Fite:(Weeks 92) Sacrificeidn extresis MacroscopicObservations: Pituitary Skin Liver MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Pancreas Parathyroid Pituitary Skin Testis/Epididysis -Nmrrhigic mass,I ce dia. -lWr thinningin dorsalarea. Ultwated lesions,both hind footpads. -Slightlpyale -Sinusoidalectasia,cortex,diffuse,moderate -Not eximintd,missing -Chronicprogressivenephropathy,mild -Portalbileductproliferationm,inimal Portalsonmuclearcellinfiltrates,iniial -Perivasculasrononucloairnfiltrates,ild -Isletcalladencea -Not examined,not in plantof section -Adenoma -Podadereatitisu,lcerative,marked Atrophy,moderate Lossof hairfolliclesand epidermal thickeningd,orsalskin. -Not tiasined,aissing Tht followingtissueswerefoundto be withinnormallimits: Spleen,Heart,Stomach,UrinaryBladder,Prostate,Thyroid,Trachea,SalivaryBland. Species:Rat Project Number: 0281CROO12 Suerized STAR Page: 165 356 Smarized SingleTabulateAdnimalReport(continued) ladividitaMlicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 AnisalNumber:IR-3766 Box:kle Broup: 3) FN-392430 ppe Fate:(Weeks106)TerminalSacrifice MicroscopicObservations: MicroscopicObservations: Kidney Liver Parathyroid Thyroid Trachei -Novisiblelesions. -Chronicprogressivenophropathym,inimal -Portalsonanucleacrellinfiltratem,ild Portalbileductproliferatiomni,ld Cystaiddegeneritionfgocal,mild Negalocytosism,ild -Not examined,missing -Not exaained,missing -Tracheitisc,hronica,ild The followintgissueswerefoundto be withinnormallimits: Spleen,Heart,Lung,Testis/EpididysiPsr,ostate,Stomach,UrinaryBladder,Adrenal,Esophagus, SalivarySlandlPituitaryP,ancreas. ---------------------------------------- ------ AnimalNumber:IR-3767 Sex:Nale Broup: 31 FN-352430 ppe Fate:(Weeks106)TerminalSacrifice Microscopic-Observations: MicroscopicObservations: Adrenal Heart Kidney Liver Lung Parathyroid -Novisiblelesions. -Cwticalvacuolationl,ocalareas,sild Medullarcyellhyperplisiao,ultifocal, moderate -NyKarditis,chronicnonsuppurative, oulti4ocals,ild -Chronicprogressivneophrepathym,aerite -Portalsonanucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld Nepatocytaolteritionv,acnalateds,ild -Vasculasrintralizatiosni,ld Perivasculawrnonuclearinfiltrates,ild Hemorrhageo,ultifocals,ild -Notexaminedn,ot in plantof section The followingtissueswerefoundto be v44thinnormallimits: Spleen,Testis/EpididysiPsr,ostate,Stomach,UrinaryBladder,Thyroid,Trachea,Esophagus, SalivaryBland,PituitaryP,ancreas. - - --- ----------------------------- species:Rat Project Number: 0261CROO12 SumarizW STARPage: 166 357 SummarizedSingleTabulatedAnimalReport (continued) ledividviiMlacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: 11-3760 Sex:Halt Broup: 3) FN-3924 30 ppe Fate: lveek-106)TerminalSacrifice MacroscopicObservations: Skin MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lung Parathyroid Skin SPIM -Raised,circularlesionsgboth hind footpads. -Sinusoidaelctasia,cortex,oulti4ocalm,ild -Not examined,missing -Hyacarditisc,hronicnonsuppurative, sultifocals,ild -Chronicprogressivenephropathy,minimal Calculus,pelvic -Cystoidegenerationo,ultiikal,sild Hipatocytaolterationv,acuclatedo,ultifocal, moderate -Yoscularmineralizationm,ild Pneumoniai,nterstitialc,hronic,sultifocal, mild Hineralizationf,ocal,parenchymalm,ild -Not examined,not in plantof section -Pododereatitisu,lcerativeb,ilateralm,arked -Hematopoitisiesx,tratedullaryi,ncreased, mild The followingtissueswerefoundto be withinnormallimits: Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Thyroid,Trachea,Salivary61&nd, Pituitary,Pancreas. - ------------ - Animal Number: IR-3769 Set: Hale Broup: 3) Fli-392340 pps Fate: lneekz106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lung -No visiblelesions. -Corticalvacoolationl,ocalareas,moderate Sinusaidaelctnia, cortex,sild -Not examined,missing -NyKarditis,chronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropiithys,ild Calculus,pelvic -Cystoiddegenerationo,ultifocals,ild Hep&tKyte alterationv,acuolitod, local areas,moderate -Yascularsintralizationsgild Hemorrhage,local areas, moderate swits: Rat Project Number: 0281CROO12 Wavized STAR Page:t47 3zc)0o SummarizedSingleTabulatedAnimalReport (continued) ledividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year OralToxicity-OncogenicitSytudyin Rats -----------------------Animal Number: IR-3769 Six:Halt Group: 1 3) FN-392430 ppa Fate: (Uteka106)TerminalSacrifice Table:2 MicroscopiOcbstrvations(continued): Parathyraid Pituitary Testis/Epididysis Thyroid -Notexamined,not in plantof section -Adenoma -Vascularmineralizationm,ild -Cyst,colloid The followingtissueswerefoundto be withinnormallimits: Spleen,Prostate,Stomach,UrinaryBladder,Trachea,SalivaryBlind, Pancreas. ------------ -- ------------- ----- -------------- Anisal Number:IR-3770 Sex: Male Group: 3) FN-392430 ppi Fate:lneekz102)Sacrificedin extremis MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lung Pituitary -Largemass,1.5 1 0.9 ca. -Corticalvacoolationf,ocal,moderate Sinusoidalectasia,cortex,focal,aild -Not examined,missing -Nyocarditisc,hronicnonsuppuratived,iffuse, moderate -- @, --,l@ -Chronicprogrissivenephrop&thys,ild -Portalsononucleacrell infiltratem,oderate Portalbileductproliferatiosni,ld Hipitacytealterationv,acualatedotultifocal, aild -Vascularmineralizations,ild Pneumoniai,nterstitialc,hronic,oultifocal, mild Hemorrhage,local areas, moderate -Adenoma The followingtissueswerefoundto be withinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea, SalivaryBland,Pancreas. ----------------- --- --------------------- ------------ --- --------- --------------Anizal Number: IR-3771 Sex: Hale Group: 3) FN-392430 pps Fate: (Neekz106)TerminalSacrifice MacroscopicObservations: Thyroid MicroscopicObservations: Adrenal -Possiblyslightlyenlarged. -Corticalvacuclation4,ocal,nowatt Species:Rat Project Number: 0261CROO12 J7 Summarized STAR Page: 168 Sus"rizeSdinglTeabulateAdnimaRleport(continued) IndividuBaalcroscopaincdRicroscapOibcservatio-n-s RikeLraboratorIinecs.,3N FN-3924T:ooYearOralToxicity-OncogenSitcuidtyiynRats Table:2 Animal Number: IR-3771 Sex: Kale Group: 3) FM-392430 ppe Fate: (Neekz106)TerminalSacrifice NicroscopiOcbservations(continued): Esophagus Heart Kidney Liver Lung Pancreas Parathyraid Pituitary Prostate -Notexamined,sisring -Nyocarditisc,hronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropathy,moderate -Hipatocytveacuolations,ultiofcal,mild Negalocytositm,inimal -Vascularmineralizations,ild -HYPefpla5i&, iSlIt CIII9 fK&I, moderate -Notexamined,not in plantof section -Adenoma -Prostatitisa,cute,marked The followingtissueswere foundto be withinnormallimits: Spleen,Testis/EpididysisS,tomach,UrinaryBladder,Thyroid,Trachea,SalivaryBland. --- --- -- ----------------------------------- --- --- -- --- - Anisal Number:IR-3772 Sex: Nale Group: 31 FN-3924 30 ppe Fite:(Veeks101)Sacrificeidn extromis NacroscapicObservations: Pituitary NicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Pituitary Prostate SalivaryGland Stomach Testis/Epididysis Thyroid -Raised&ass, I ce dia. -Corticalvacualitions,ultifocalm,ild -Not examined,missing -Chronicprogressivneephropithys,ild -Portalsononucleacrell infiltrates,ild -Vascularmineralizationm,ild Alveolar"crophages,oultifocalm,ild Perivisculasrononucleairnfiltrates,ild -Adenome -Mt examined,missing -Not examined,missing -Edema, subsucosal,moderate -Tubuleatrophy,ispersatogenesidti,ffuse, bilaterals,ild -Ultimcbranchiaclyst Folliculahryperplasiac,ystic,unilateral, mi)d The followingtissueswe foundto be withinnormallimits: Spleen,Heart,UrinaryBladder,Parathyroid,Trachea,Pancreas. ----------------------------------- Species:Rat ProjectNumber:0261CROO12 Sm arizedSTAR Page: 169 360 gumwized SingleTabulatedAniallReport(continued) IndividualMacroscopicand MicroscopicCbwvltiOns RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-ftcogeniciSttyudyin Rats Table: 2 AnimalNumber:IR-3M Six: Kale Group: 3) FN-3924 30 ppe Fate: (Netka106)TerminalSacrifice MicroscopicObservations: MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lung Parathyroid Pituitary -No visiblelesions. -Corticalvacuolationo,ultifecals,ild Medullarycall hyperplasiaf,ocal,minimal -Not examined,missing -Myocarditisc,hronicnonsuppurative, sultifocalm,ild -Chronicprogressivenophropathy,marked -Portalbileductproliferationm,ild Nepatocytealteration,vacualatedf,ocal, sild Negalocytosis,minimal Repitocytaelterationb,asophilitf,ocal, mild -Vascularsintralizatioani,nimal -Not examined,not in planeof section -Adenm The follaningtissueswerefoundto be vithinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,LirinarByladder,Thyroid,TrKhea, SalivaryGland, Pancreas. --- ---- -- ---- - -------- - -------------------- Anisal Number: IR-3n4 Be%: Kale group: 3) FN-3924 30 ppe Fate: (Veekz 104) Found Dead Microscopic Observations: Skin Pituitary Kidney Microscopic Observations: Adrenal Kidney Liver Lung Pancreas Parithyroid Pituitary - --------- -Circular,ulceratedlesion,0.3 ce dia, in dorsal area. -Enlarged with hemorrhagic area, 0.6 ce dia. -Appear pitted -Sinusoidaltctisia,cortex,oultifocal,sild -Chronic progressive nophropathy, marked -Portalsononuclearcell infiltrate,sild Portalbile duct proliferation,sild Cystoid degeneration,oultifocal,sild -Vascularmintralization,sild Alveolarucrophages, oultifocal,sild -Hyperplasia,islet cell, focal, moderate -Fibrosis, moderate -Adenosa Species: Rat Project Number: 0261CROO12 Sowized STAR Page: 170 361 Sm arizeSdinglTeabulatAendinaRleport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3q24:Two Year OralToxicity-bcogenicitSytudyin Rats - --- -------Animallumber: IR-3774 Six: Kale Fate: (Weekx104) FoundDead Group: 3) Fli-392340 ppe Tablit2: MicroscopiOcbservations(continued): Skin Spleen -Dusititis,chronic,mild -Hemosiderosiss,ild Thefollovingtissueswerefoundto be vithinnormallimits: Heart,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Thyroid,Trachea,Esophagus, SalivarySland. ------------------------------------------------------------ -Animal Number: IR-3775 Sex: Nale Group: 1 3) FN-3q2430 ppe Fite: (Weekz106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Heart Kidney Liver Lung Pituitary Prostate Trachea UrinaryBladder -No visiblelesions. -Myocardiaflibrosiso,ultifocals,inisaf -Chronicprogressivenophropathy,moderate -Hopatocytovacuclationo,ultifocal,minimal %alkytosist minimal -Vascularsintralizaticm,ild -hostatitisa,cute,mild -Tracheitisc,hronic,moderate -Mt examined,missing The 4ollowingtissuesvere.foundto be vithinnormallimits: Spleen,Testis/EpididysisS,tomach,Adrenal,Thyroid,Parithyroid,Esophagus,SalivaryGland, Pancreas. ------ ------------- --- Animal Number: IR-3776 So%: Kale Group: 3) FN-3924 30 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Eye Pituitary Skin -opacityl,eft -Raisedmass,0.6 co dia. -Raisedulcer,I ce dia.,an back;raised circularinflassedlesions,bothhind footpads. MicroscopicObservations: Adrenal -Sinusoidalectasia,cortex,diffuse,moderate Esophagus -Not examined,missing Heart -Nyocardititc,hronicnonsuppurative, oultifocals,ild - - ----- --- ----- --- ----------------- Species:Rat Projtct Number: 0281CROO12 Summarized STAR Page: 171 362 SumarizeSdinglTeabulatAendimaRleport(continued) IndividuNaalcrostopaincdMicroscopOibcservations RikeLraboratorIinecs.,3N FN-3924T:woYearOralToxicity-OncogenSitcuidtyiynRats Table:2 Anisal Number: IR-3776 Six:Nile Group: 3) FN-392430 pps Fate: (Meeks106) TerminalSacrifice MicroscopicObservations(continued): Kidney Lung Parathyroid Pituitary Skin -Chronicprogressivenephropathy,sild Pelvicsineralizatiosni,ld -Vascular aintralization, sild Alveolar ascrophages, oultifocal, moderate Perivascular smonuclear infiltrate, BUItifKal, moderate -Not examined, missing -Adenosa -PodDdereatitis,ulcerative,bilateral,marked Basal cell tumor, benign, back The followingtissues were found to be withinnormal limits: Spleen,Liver,Testis/EpididyaiPsr,ostate,Stomach,UrinaryBladder,Thyroid,Trachea, SalivaryGland,Pancreas,Eye. ------------------ -------------Animal Number: IR-.3777 Sex: Nale Group: 3) Fli-392340 pps Fate: (Weekz106)TerminalSicrifice MicroscopicObservations: MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Parathyroid Trachea -No visiblelesions. -Corticalvacuolationf,ocal,minimal -Not examined,missing -Pyelitisa,cute,unilateralm,ild -Portalitononuclecaerllinfiltrates,iniaal' Portalbileductproliferationm,inimal Repatocytevacuolitionc,entrilabular, moderate Negalocytosis,moderate Nepatocytealterationv,icualatedo,ultifocal, mild -Vascularsineralizationm,oderate Hemorrhage,IK&I areas,mild -Notexamined,not in planeof section -Tracheitis, chronic, mild The following tissues were found to be within normal limits: Spleen,Heart,Testis/EpididysisP,rostite,Stomach,UrinaryBladder,Thyroid,SalivaryGland, Pituitary,Pancreas. ---- ---- - - ------------ - ------- SpecieRsa:t ProjeNcutmbe0r2:91CRO12 SwwarizSeTdARPage1:72 363 SummarizedSingleTabulatedAnimalReport tcontinued) IndividualMicroscopicand MicroscopicObwvations RikerLaboratoriesI,nc. 3H FN-3924:Two YearUral Toxicity-I)ncogenicSituydyin Rats Table: 2 Animal Number: IR-3778 Six:Halt Group: 3) FN-392430 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Esophagus Heart Kidney Lung Pancreas Pituitary Spleen Thyroid -Raised,0.7 ce dia.,hemorrhagiclesion. -Sinusoidaelctisia,cortex,diffuse,mild Pheochrosecytosab,enign,unilateral -Not examined,missing -Nyocarditis,chronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropithy,moderate Pelvicmineralizationm,oderate Calculus,pelvic,bilateral,marked -Yascularmineralizationm,ild Pneumoniai,nterstitialc,hronic,oultifocal, mild Alveolarmacrophigesf,ocal,sild Perivasculamrmanuclearinfiltratem,ild Hemorrhage,Bultifocal,mild -isletcell adenona -Adenoma -Nmiiderasis,mild -HyperplasiaC,cell,4ocal,mild Cyst,colloid The followingtissues*erefoundto be withinnormallimits: Liver,lestistepididysiPsr,ostate,Stomach,UriniirByladder,ParithyroidT,rachea, SalivaryBlind. - - - --------------------------------------------------- Animal Number: IR-3779 Set: Halt Group: 3) M3924 30 ppe Fite: (Neekz106)TerminalSacrifice MacroscopicObservations: Pituitary Adrenal MicroscopicObservations: Adrenal Esophagus Kidney Liver ------------- - ---------- -Small,0.3 cm dia.,hemorrhagiclesion. -Leftadrenalenlarged. -Pheochrosocmyt , benign,unilateral -Not examined,missing -Chronicprogressivenephropathy,mild Pelvicmineralizationm,ild Calculus,pelvic,marked -Portalmmonuclearcellinfiltratem,inimal Portalbileductproliferationm,inimal Cystoiddegenerationf,kal, sild Nepatocytaelterationv,kuolated,focal, mild Negalocytesis,minimal Species:Rat Project Number: 0281CRO12 SummarizedSTAR Page: 173- 364 Smarized SingleTabulatedAniul Report(continued IndividualNacroscopicand MicroscopicObservations RikerLAboratoriesIpnc. 3H FN-3q24:Too Year Oral Toxicity-OntagenicitSytudy in Rats - -------- ------- ---- -Anisal Number: IR-3779 Six: Hale Fate: (Neekm106) TerminalSacrifice Group: 3) Frr392430 pps Table: 2 MicroscopicObservations(continued): Lung Pancrois Pituitary -Vascularmineralizations,ild -Hyperplasiai,slet cell, oultifocal,moderate -Not examined, missing The follovin.t9issuesvere foundto be withinnormallimits: Spleen,Heart,Testis/EpididysisP,rostate,Stomach,Urinary Bladder,Thyroid,Parathyraid, SalivaryGland, Trachea. ------------------------------------------------- --- ------ Anisal Number: IR-3780 Sax: Halt Group: Fite: (Week=106) TerminalSacrifice 3) FM-3924 30 ppe MicroscopicObservations: MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung -No visiblelesions. -Sinusoidalectasia,cortex,focal,moderate -Not examined,missing -Chronic progressivenephropathy,minimal -Regalocytosis,mild -Vascularmineralization,mild Pneumlai interstitialc,hronic,oultifocal, sild Alveolareacrophages,oultifocal,sild Perivasculamronaclear infiltritem,ild The follovingtissuesverefound to be vitbinnormallimits: Spleen,Heart, Testis/EpididyitiPsr,ostate,Stomach,UrinaryBladder, Thyroid,Parathyraid, Trachea,SalivarySland, Pituitary,Pancreas. ----------------------------------------------------------------- -----------Animal Number: IR-3781 Sex: Nile Group: 1 3) Ffl-392430 ppe Fate: (Neek-106) TerminalSacrifice Racrascapic Observations: Skin Pituitary -Raisedinfliand lesionleft hind footpad. -Mass, 0.5 x 0.7 ce. Microscopic Observations: Adrenal Esophagus Heart -Sinusaidalectasia,cortex,diffuse,ikild -Not examined, missing -Myocarditis,chronicnonsuppurativt, oultifocal,mild Kidney -Chronic progressivenephropathy,minimal Pelvicmineralizationm,ild Calculus,pelvic,moderate ------------------------------------------ -- ------ Species: Rat Project Number: OnICROO12 Summarized STAR Page: 174 365 SummarizSeidnglTeabulatAendimaRleport(continow) IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3N FN-3924T:woYearOralToxicity-OncogenSittuidtyiynRats Table2: AnisaNlumberI:R-3781 Sex:Halt Group:3)FN-392340ppe Fate:(Neek1a06)TorainaSlacrifice Nicroscc)Opbiscervatio(ncsontinued): Liver Lung Pancreas Parathyroid Pituitary Skin -"Iocytosimsi,nimal -Yasculsairneraliziitmiiolnd, Alveolamracrophageosu,ltifocamli,ld -Acinaartrophym,oderate -Notexaminendo,tinplantofsection -Adenosa -Padodereatiutlicse,rativuen,ilateral, marked Thefollonintgissuesserefoundtobemitbinnormallimits: SpleenT,estis/EpididyPsrioss,tatSet,omachU,rinarByladderT,hyroidT,racheaS,alivar6y1&nd. ------------------------ AnisaNlumberI:R-3782 Sex:Kale Group: 3)FN-392340ppe Fate:(Week-8-2)Sacrificiendextresis MacroscopOibcservations: Skin Spleen Stomach LymphMade(sesenteric) MicroscopOibcservations: Esophagus Heart Kidney Liver Lung LymphNode(sesonteric) Pancreas Parathyroid Prostate Skin SPIM Stm ch UrinarByladder -Ulceratecdi,rculalresionl,efthind footpid. -Enlargweidthmultiplreaisecdircular lesionsr,anginfgrom0.2- I cadia. -Ulceratiionnpylorivcalvearea. -Enlarged -Notexaminemdi,ssing -Malignalnytmphosmai,xed -Malignalnytaphosmai,xed Proteirnesorptidornopletssi,ld -Malignalnytmphossai,zed -Yasculasrintralizatisoinl,d Malignanltymphosmai,xed -Malignalnytmphosmai,xed -Malignalnytaphosmai,xed -Notexaminedn,otinplantofsection -Prostatitaicsu,tem,oderate -Pododereatiutlicse,rativuen,ilateral, marked -Malignalnytaphossai,zed -Ulcerm,oderate -Epithtllhiyiplerpla!isiam,pled,iffusem,ild Thefollo"intgissuevstrefoundtobewithinnormalimits: Testis/EpididyAsdirse,nalT#hyroidT,racheaS,alivarGylandP,ituitary. speciesR:at ProiecNtumber0:281CRO12 SummarizSeTdARPago:175 366 SummarizedSingleTabulatedAniul Report (continued) IndividualNatroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year OralToxicity-OncogenicitSytudyin Rats Table:2 AnimalNumber: IR-3793 Sex: Malt Group: 3) FK-392430 pps Fate:lneekz 98) Sacrificeidn extrtmis MacroscopicObservations: Pituitary Liver Kidney Ttstis/Epididysis stideach MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Parithyroid Pituitary SalivaryBland Stomach Testis/Epididysis -larkraised@ass,0.6 co dia. -Palo -Palo,pittedand enlarged. -Bothtestesappearsmall. -Thickenedmillsnear pylorus. -Pheochromacytosab,enign,unilateral -Not examined,missing -Myocardiaflibrosis,localareas,sild -Chronicprogressivenophropathy,marked -Repatocytevacualation,diffuse,moderate -Hyptrplasia,marked -Adenm -Not examined,missing -Mineralizatioonu,ltifocals,ild -Tubuleatrophy,aspersitogtnesibsi,lateral, moderate Thefollovingtissueswertfoundto be vithinnormallimits: Spleen,Lung, Prostate,UrinaryBladder,Thyroid,Track@&,Pancreas. ----------------- ----------- --- - --- ---- -- -- -- Animal Number: IR-3764 Sex: Hale Group: 3)-FN-392430 ppe Fate: (Week=106)TerminalSacrifice -- --- --- --- ---- - MicroscopicObservations: MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lung Pituitary Testis/Epididysis -No visiblelesions. -Corticalvacualationf,ocal,mild Sinusoidaelctasia,cortex,diffuse,mild -Not examined,missing -Myocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenophropathy,minimal -Nevalocytosism,inimal -Vascularmineralizationm,ild Hemorrhage, marked -Adenoma -Tubuleatrophy,ispersatogentsibsi,lateral, moderate The follovingtissueswerefoundto be vithinnormallimits: Spleen,Prostate,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea,SalivaryBland, - --- -- ------------ - -- - ------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 176 367 Bumwized SingleTabulatedAnimalRoWt (continued) IndividualMacroscopicand MicroscopicObw vations RikerLaboratoriesIgnc. 3N FN-3924:Too YearOral Toxicity-OncoloniciSttyudyin Rats -------- -- Animal Number: IR-3704 Sex: Halt Group: Fite: (Weeks106)TorainalSacrifice 3) FN-392430 ppe Table: 2 MicroscopicObservationslcontinued): The followingtissu*swerefoundto be withinnormallimits(continued): Pancreas. - - -------- ------------------ Animal Number: IR-3785 Sex: Male Group: 3) FN-392430 pps Fate: (Weekz1-06)TerminalSacrifice MicroscopicObservations: MicroscopicObservations: Adrenal Esophagus Liver Lung Pancreas Pituitary -No visiblelesions. -Siousoidaelctasia,cortex,localareas, moderate -Not examined,missing -Portalsononucleacrellinfiltratem,ild Hepatocytevacuolationo,ultifocal,mild Regalocytosism,ild -Vascularmineralizations,ild -kinar atrophy,mild -Adenosa The followingtissueswere foundto be withinnormallimits: Spleen,Kidney,Heart,Testis/EpididymisP,rostate,Stomach,LirinarByladder,Thyroid, Parathyraid,Trachei,SalivaryGland. ----------------------------- - -- - -------------- -- ------------------- ----------- Animal Number: IR-3796 Sex: Nale Group: 1 3) Ffl-392340 pps Fite: (Weeka106)TerminalSacrifice MicroscopicObservations: Liver MicroscopicObservations: Adrenal Heart Kidney Liver Lung -Darklesion,0.3ce dia.,in medianlobe. -Sinusoidaelctasia,cortex,unilateral, marked -Nyocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropathy,minimal Ptlvicmineralizationm,oderate -Portalsononucleacrellinfiltrates,ild Nepatocytealteration,vacuolated, localareas,wderite Nqalocytosisgminimal -Vasculasrintralizatiosni,ld Hemorrhage,local areas,moderate Species:Rat Project Number: ONICROO12 Summarized STAR Page: 177 368 Sumrized SingleTabulatedAnimalReport(continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratories,Inc. 3N FN-3924: Too Year Oral Toxicity-OncogenicityStudy in Rats Table: 2 Animal Number: IR-3706 Sn: Kale Fite: tneekz 106) TerminalSacrifice Group: 1 3) FN-3924 30 ppo Microscopic Observations (continued): The followingtissues were found to be within normal limits: Spleen, Testis/Epididysis,Prostate, Stomach, Urinary Bladder, Thyroid, Parathyroid,Trachea, Esophagus, Salivary Blind, Pituitary, Pancreas. -------- - ------------- -- ---- ------ Animal Number: IR-3707 Sax: Nile Broup: 3) FN-3924 30 ppe Fite: (Weekx 106) Terminal Sacrifice Microscopic Observations: Microscopic Observations: Adrenal Esophagus Kidney Liver Lung -k visiblelesions. -Corticalvacuolation,focal, mild -Not examined, missing -Chronic progressive riephropathy,sild Pyelitis,acute, unilateral,moderate -Portalsononuclearcell infiltrate,sild Portalbile duct proliferation,sild Negalocytosis, moderate -Perivascularsmonucleikrinfiltrate,sild. Hemorrhage, local areasl moderate The followingtissueswe found to be within normal limits: Spleen, Heart, Testis/EpididysisoProstate, qtoaachl Urinary Bladder, Thyroid, Parathyraid, Trachea, Salivary Bland, Pituitary, Pancreas. --------------------------- ----- - -------- - -------------------- -- ------------------- AniAil Number: IR-3768 Sex: Kale Fite: (Week= 106) Terminal Sacrifice Group: 3) FN-3924 30 ppe Microscopic Observations: Skin Kicroscopic Observations: Esophagus Kidney Liver Parathyroid Skin Trachea -Circularinflmed lesion,left hind footpad. -Not examined, missing -Chronic progressive nephropathy, minimal -Portal mononuclearcell infiltrate,minimal Portal bile duct proliferation,minimal Negalocytosis, moderate -Not examined, not in plane of section -Podadereatitis,ulcerative,unilateral, marked -Tracheitis,chronic,mild The followingtissues were found to be within normal limits: Spleen, Heart, Lung, Testis/Epididysis,Prostate, Stomach, Urinary Bladder, Adrenal$ Thyroid, ------ --- -- --- ----- - -------- species: Rat Project Number: 0281MOO12 Smarized STAR Page: 176 369 SummarizedSingle TabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoritsI,nc. 3N FN-3924:Two Year OralToxicity-OncogeniciSttyudy in Rats Table:2 AniaalNuabor: IR-3798 Sex: Halt Group: 3) FN-3924 30 ppe Fate:(Netkz106)TerminalSitrifice NicroscopicObservations(continued): The follovintgissues*erefoundto be vithinnormallimits(continued): SalivarySlandlPituitary,Pancreas. ------------------------------- ------------------------ ----------------- - ----- Anisal Number: IR-3789 Sex: Male Group: 3) FN-3q24 30 ppe Fate: (Weekx..79S)acrificedin extremis MacroscopicObservations: Pituitary MicroscopicObservations: Heart Kidney Liver Lung Parathyroid Pituitary Spim -Enlargeddue to I 1 0.7 ce mass. -Nyocarditisc,hronicnonsuppurative, oultifK&I,mild -Chronicprogressivenephropithy,minimal -Portalwnonucltarcallinfiltrates,ild Nepatocytevacuolitiono,ultifocalm,ild Ngalocytesis,mild -Vascularmineralizationm,ild Alveolarastrophageso,ultifocals,ild -Not examined,not in plantof section -Monm -fteosiderosis,ild The follovingtissues*erefoundto be *ithinnormallimits: Testis/EpididysisP,rostate,Stomach,UriniryBladder,Adrenal,Thyroid,Trachei,Esophagus, SalivaryGland,Pincreas. -- ---------------------------- -------------------------------- -- - -------------------- Animal Number: IR-3790 Sex: Halt Group: 3) FN-392430 ppe Fite: (Weekz106)TerminalSacrifice MacroscopicObservations: Skin Liver MicroscopicObservations: Adrenal Esophagus Heart Kidney -Raisedin4laand lesions,both hindfoutpads. -Raisedpale mass,1.5 x I ce dia.,caudate lobe. -Corticalvacuolationa,ultifocals,ild -Not examined,missing -Myocardiaflibrosis,focal,minimal -Pelvicmineralizationm,inimal One of pair present Liver -Regalocytosism,ild Hipatocellulacrarcinoma Lung -Vascularmineralizations,ild Pneumoniai,nterstitialc,hronic,@UltifKll, mild Alveolarmacrophales@,UltifK&I,sild Perivasculamrononucl#Arinfiltrate,mild -- -------------------- - --------------------------------------- species:Rat Project Number: 0281CROO12 Suuariztd STU Page: 179 370 Sumrized SingleTabulatedAnimalReport(continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:TNo Year OralToxicity-UncognicitSytudy in Rats Table:2 AnimalNumber: IR-3790 Sex: Nale 6roup: 3) FN-392430 ppe Fate: (Neeka106)TerminalSacrifice HicroscopiOcbservations(continued): Skin Testis/Epididysis Thyroid 0 -Pododersatitiusl,cerativebgilateral,marked -Yascularmineralizations,ild -C celladenosa Follicularadmosa The follovingtissuesverefoundto be vithinnormallimits: Spleen,Prostate,Stomach,UrinaryBladder,ParathyroidT,rachea,SalivaryGland,Pituitary, Pancreas. ------------- ----------- ----------------------------- Animal Number: IR-3791 Set: Nale Broup: 3) FN-392430 pps Fate: (hekz 106)TerminalSacrifice MacroscopicObservations: Testis/Epididysis MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lung Testis/Epididysis Trachea -Right estis"all. -Corticavlicuolationo,ultifocals,ild -Not examined,missing -Myocarditisc,hronicnonsuppurative, localareas,moderate -Chronicprogressivenephrepathy,aild Pelvicmineralizationm,inimal Calculus,pelvic,moderate -Portalbileductproliferatiosni,ld Nepatocytovacualationc,entrilobular, moderate Cystoiddegeneration4,ocal,mild Hapatocytealteration,vacuolatedf,ocal, mild NegAlKytOSiS, moderate -Yasculirmineralizationm,ild Alveolar"crophages,oultifocals,ild -Tubuleatrophy,aspereatagenesisu,nilateral, marked -Tracheitisc,hronic,mild The follovingtissuesverefoundto be mithinnormallimits: Spleen,Prostate,Stomach,UrinaryBladder,Thyroid,PirathyroidS,alivaryGland,Pituitary, Pancreas. - - ---------- --- ------ ----------------------------------- -- -------- Species:Rat Project Number: 02BICROO12 Smarized STAR Page: IBO 371 SummariSziendglTeabulatAendimaRlepor(tcontinued) IndividNuaaclrosroapnidNcicroscaOpbiscervations RikerLaboratoriIensc,.3N Ffl-3q2T4o:YearOralToxicity-OntogniRcuidtyyinRats Table:2 Animal Number: IR-3792 sn: Halt Group: 3) FN-392430 pps Fate: (Weeka103)Sacrificedin extromis MacroscopicObservations: Liver MicroscopicObservations: Esophagus Heart Liver Lung Parathyroid -Possiblyslightlypale. -Not examined,missing -Nyocarditisc,hronicnonsuppurative, oultifocalm,ild -Portalsononucloacrellinfilrtate,sild Portalbileductproliferatiosni,ld -Yascularmineralizations,ild Granuloma,oultifocallmild -Notiiininedonot in planeof section The fDIIDNiRgtissueswerefoundto be withinnormallimits: Spleen,Kidney,Testis/EpididysiPsr,ostate,Stomach,UrinaryBladder,Adrenal,Thyroid, Trachea,SalivaryBland,Pituitary,Pancreas. ---------------------------------- -- --- - - - --- - -- - ---------- ------ Animal Number: IR-3793 Sex: Hale Group: 3) FN-392430 ppe Fate: (Weekx106)TerminalSacrifice MicroscopicObservations: Skin Pituitary LymphKodt (stsenteric) MicroscopicObservations: Esophagus Heart Kidney Liver Lung Lymph Node liesenteric) Pituitary Skin Thyroid UrinaryBladder -Raisedcircurl lesion,lefthindfootpad. -Raisedmass,0.7 ce dii. -Appear hemorrhagic -Not examined,missing -NYK&rdialfibrosis,localareas,mild -Chronic progressive nephropathy, moderate Pelvic mineralization,sild -Magalocytosis, minimal -Yascular mineralization,sild Alveolar eacrophages, oulti4ocal, mild Perivascular sonanuclear infiltrate, mild -Hemorrhage,moderate -Adenoma -Pododereatitiusl,cerativeu,nilateral, marked -HyperplasiaC,call,oultifocals,ild Ultisabranchiaclyst -Calculus Epithelialhyperplasia,simple,diffuse,mild The followingtissuesmere found to be withinnormal limits: Spleen,Testis/EpididysisP,rostate,Stomach,Adrenal,ParithyroidT,rachea,SalivaryGland, Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 181 372 guuarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-bcoginicitSytudyin Rats Animal Number: IR-3793 Sex: Nale Group: Fate: I#eekz106)TerminalSacrifice - -- --- ---- 3) FN-3q2430 ppe Table:2 MicroscopicObservationslcontinued): The followingtissueswerefoundto be withinnormallimits(continued): Pancreas. --- ------------------------------ -- -- --- -------- Animal Number: IR-3794 Sex: Hale Group: 3) FN-3924 30 ppe Fate: (Weeks106)TerminalSacrifice --- - ---- ------ MacroscopicObservations: MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lung Parathyroid Prostate Thyroid -No visiblelesions, -Sinusoidalectasia,cortex,diffuse,moderate -Not examined,missing -Myocarditis,chronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropathy,aild -Portalstmonucleacrellinfiltratea,ild Repatocytevacuolationo,ultilkal,moderate Hepatocytealteration,vacuolatedo,ultifocal, mild hgalocytosiss,ild -Vasculaarintralizatiosni,ld Hemorrhage,local areas,moderate -Adenona -Prostatitisa,cute,minimal -Ultimobranchiaclyst The followingtissuesmerefoundto be withinnormallimits: Spleen,Testis/EpididysisS,tomach,UrinaryBladder,Trachea,Salivary61and,Pituitary, Pancreas. ---------------- ---------------------------- - - -- --------------- Animal Number: IR-3795 Sex: Nale Sroup: 3) FN-392430 ppe Fate: (Weeks106)TerminalSacrifice MacroscopicObservations: Skin MicroscopicObservations: Adrenal Heart 4irs, slightlryaisedmass,I ce dia.,left side. -Ndullarycellhyperplasisf,ocal,sild Corticaldegenerationf,ocal,sild One of pair present -Nyocarditiscghronicnonsuppurative, oultifocalm,ild Species:Rat Project Number: OnICROO12 Sunrized STAR Page: 102 373 kmrized SingltTabulatedAnimalReportleantinued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3724:Two Year OralToxicity-oncogenicitSytudyin Rats ----- ---- -- ----------- - ----AnimalNumber: IR-3795 Six:Nile Group: Fate: (Meeks106)TerminalSacrifice 3) FN-392430 ppi Table:2 MicroscopicObservationslcontinued): Kidney Liver Lung Parithyroid Prostate Skin Spleen -Chronicprogressivenephropithy,mild -Portalsononucleacrtllinfiltrates,ild Portalbileductproliferationm,ild Repatocytveacuolationo,ultifocal,aild Repatocytoalterationv,icuola.teodu,ltifocal, sild movalocytosis,minimal -Vascularmintralizatim,mild Alveolareacrophaps,localareas,moderate Perivasculasronmuclearin4iltrattm,ild -kt examined,not in plantof section -Prostatitisa,cute,moderate 4ibroma -Hetosiderosism,ild The followingtissueswere foundto be withinnormallimits: Testis/EpididysisS,tomach,UrinaryBladder,Thyroid,Trachea,Esophagus,Salivary61and, Pituitary,Pancreas. --- ------------- ---- ------------- Animal Number: IR-3796 SeK: Male Broup: 3) FN-392430 ppe Fite:(Neekx19)Sacrificeidn extrnis MacroscopicObservations: Pituitary -Raisedmiss,0.6 co dia. Skin -Ulceratedrighthind footpad. Adrenal -Both appearenlarged. MicroscopicObservations: Adrenal -Sinusaidaelctasia,cortex,diffuse,marked Heart -Nyocarditisc,hronicnmsuppurative, oultifocalm,ild Kidney -Chronicprogressivneephr"ithy,sild Liver -Hepatocytveicuolationo,ultifocils,ild TelingiectiisfiKs&,I, mild Lung -Vascularmintrilizatims,ild Pneumoniai,ottrstitialc,hronic,oultifocal, mild Alveolarmacrophageso,ultifocal,mild Parivasculasrononucleairnfiltrates,ild Pirathyroid -Nottiaitinedn,ot in planeof section Pituitary -Adenosa Skin -Pododereatitiusl,cerativeu,nilateral, marked - - ---- -- ---------- ---- ---- --- --- ----------- Species:Rat Project Nwiber: 0281CROO12 Sumarized STAR Page: 183 374 Suuarized SingleTabulatedAnimalReport (continuW),IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Tvc yearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3796 Sex: Kale Broup: 3) FII-3q2430 ppe Fate: (gooka Sacrificedin Lixtresis HicrorcapicObservations(continued): Thyroid UrinaryBladder -Ultionbranchiaclyst -Not examined,missing The followingtissues*ere foundto be withinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,Trachea,Esophagus,SalivaryBlind,Pancreas. - -- -- ---------- Anisal Number: IR-3797 Sex: Kale Fate: (Neek= 94) FoundDead Group: 3) FN-392430 ppe MacroscopicObservations: Pituitary Urinirylladder MicroscopicObservations: Adrenal Liver Lung Pituitary Prostate Spleen UrinaryBladder -Raisedmass, I ce dia. -Calculusin lusen,appearsto be blocking uretheraolrifice. -Corticavlacuolationo,ultifocals,ild -Portalsononucleacrellinfiltratem,ild Portalbileduct proliferationm,oderate -Vascularsintriklizatimoinljd -Not examined -Adenoma -Prostatitisa,cute,marked -Hem iderosis,moderate -Cystitis,acutiim,oderate Epithelialhyperplasias,imple,diffuse, moderate The followingtissueswere foundto be withinnormallimits: Kidney,Heart,7istis/EpididysisS,tomach,Thyroid,Parathyroid,Trachea,Esophagus, SalivaryBland. --- --- ----------- -- -------------------------------- -- --------- ---- -------------Animal Number: IR-3798 Sex:Halt Group: 3) FN-392430 ppe Fite: (Weekz106)TerminalSacrifice MicroscopicObservations: Prostate MicroscopicObservations: Esophagus Kidney Liver -Firemiss,3.5 co dia.,involvingneckof bladder. -Not examined,missing -Chronicprogressivenephropithygsild -Portilsononucleicierllinfiltratem,ild Portalbiltductproliferatiosni,ld Htp&tKytt alterationV,&CUOI&tld, UltifK&I, sild Negalocytesis,minimal Species:Rat ProjectNumber:0281CM12 Sworized STAR Page: 184 375 SummarizSeidnglTeabulatAendimaRleport(continued) IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3N FN-3924T:woYou OralToxicity-OncogenSitcuidtyiynRatii Table:2 Animal Number: IR-3798 Sex: Kali Group: 3) W3924 30 ppe Fate: (Nook=106)TerminalSacrifice MicroscopiOcbservations(continued): Lung Parathyroid Pituitary Prostate spleen Thyroid UrinaryBladder. -Vascular Rineralizition, sild Alveolar macrophiges, oultifocal, mild Perivascular monacloar infiltrate, sild -Neoplastic call infiltrate -Cyst,parsdistalis -Prostatiticsh,ronicd,iffuse,intersititial, marked -Knatopoitsise,itrasidullariyn,creased, moderate -C cell carcinoma Cyst,colloid 4.pitheliahlyperplasias,imple,diffuse, moderate Cystitis,chronic,mild The followingtissueswere foundto be withinnormallimits: Heart,Stomach,Adrenal,Trachea,SalivaryBland,Pancreas,SmallIntestine,LargeIntestine, Testis/Epididyais. --- ---------- Anisal Number: IR-3799 Sex: Halt Fate: (Weeks106)TerminalSacrifice Group: - -----3) FN-392430 ppe MacroscopicObservations: MicroscopicObservations: Adrenal Heart Kidney Liver Lung Pancreas Parithyroid -Novisibltlesions. -Sinusoidalectasia,cortex,mild -Myocardialfibrosis,local areas, sild Nyocarditis,chronicnonsuppurative, wdtifocal,mild -Chronicprogressivenophropathy,sild -Portalsononucloacrell infiltratei,iild Cystoiddegenerations,ild Hopatocytealterationv,icuolatedo,ultifocal, moderate liegalocytosis,minimal -Yascular mineralization,sild Hemorrhage, local areas, mild -Pancreatitis,chronic, local areas, marked -Not examined, not in plane of section The following tissues we found to be within normal limits: Spleen, Testis/Epididysis,Prostate, Stomach, Urinary Bladder, Thyroid, Trachea, Es"higns, Species: Rat Project Number: 0201CROO12 Summarized STAR Page: 105 376 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year OralToxicity-DncogenicitSytudyin Rats Table:2 AnisalNumber: IR-3799 Six: Kale Group: 3) FN-392430 pps Fate: (Neekz106) TerminalSacrifice MicroscopicObservaticms(continued): The followingtissueswerefoundto be withinnormallimits(continued): SalivaryGland,Pituitary. Animal Number: IR-3600 Sex, Halt Group: 3) FK-392430 pps Fate:fteks .96)Sacrificeidn extruis RacroscopicObservations: Pituitary Kidney MicroscopicObservations: Adrenal Kidney Liver Lung Pancreas Prostate Testl;s/Epididysis -Raisedmass,1.3 ca dia. -Enlarged,paleand pitted. -Sinusaidaelctasia,cortex,localareas,mild -Chronicprogressivenophropithy,marked -HgpatKytt alteration,vacualated,oultifocal, mild Negalocytosis,minimal -Yucular mineralizatiosni,ld Nesorrhaleplocal areas,moderate -kinar atrophy,minimal -Prostatitigsu,t# iiId -Polyarteritissi,ld The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea,Esophagus, SalivaryGland,Pituitary. --- --------------------- --------- --- --- --- - ---- - ---------------------- ------Animal Number:IR-3Nl Sex: Kale Group: 3) FN-392430 pps Fate:(Week=76)Sacrificeidn extrnis MacroscopicObservations: Pituitary Adrenal Testis/Epididysis MicroscopicObservations: Adrenal Kidney Liver Lung -Hemorrhagicmass, I 1 0.6 cm. -Rightadrenalappearsenlarged. -Lefttestisappearssmall. -Sinusaidalectasia,cortex,marked One of pairpresent -Chronicprogressivenophropathy,mild -H@PatOCyteVICUOlatiOn,GUItifK&I, mild Hopatecytoalterationv,ac"lated,oultifocal, sild -Vascularmineralizations,ild Perivasculasrononuclearinfiltratempild Hemorrhage,local areas,moderate Species:Rat ProjectNutW 0201CROO12 Wuuized STAR Page:lU 377 SummarizedSingleTabulatedAnimalReport (continutd) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FN-3924:Two Year OralTosicity-ftcoginiciSttyudyin Rats Table:2 Animal Number: IR-3801 Box: Halt Sroup: 3) FN-392430 ppe Fate:(Veek-76) Sacrificeidn extranis MicroscopicObservations(continued): Pancreas Pituitary Prostate spleen 7istis/Epididysis -kinar atrophy,mild -Adenoma -Not examined,missing -Nexosiderosism,ild -Tubuleatrophy,aspereatogenesisu,nilateral, marked The followingtissueswerefoundto be withinnormallimits: Heart,Stouch, LirinarByladder,Thyroid,Parathyraid,Trachea,Esophagus,SalivaryGland. ----------- ----------Anisal Number: IR-3602 So%: Halt 6roup: 3) FN-392430 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations: Thorax(internal) SPIM 4illed withpaleyellowfluid. -B.-tatleynlarged;paleraisedlesions,0.6 co dia. Liver Lymph Node (sese-.iteric) Lymph Node (abdominal) -kttledNith irregulasrurface. -@-Slijbtl'y'tnlanrdlebdesorrmlic, -Renil lymphnodes slightlyenlargedand hemorrhagic. Testis/Epididysis Adrenal MicroscopicObservations: Adrenal Kidney -Bilaterallsymall -Clearcyst,I ce dia.,rightadrenal. -Corticalvacuolationo,ulti4oca'ski,ld One of pair present -Chronicprogressivenephropathy,mild Pytlonephritisa,cute,moderate Liver -Partilbileductproliferatiosni,ld Nepatocytevacuclationc,entrilobular, moderate Malignantlymphola,histiocytic Lun; -Vascularmineralizationa,ild malignantlyaphola,histiocytic Hetorrhageo,ultifocals,ild LymphNode (abdominal) -Sinusoidalectiisiam,arked Malignantlymphoma,histiocytic Hisorrhages,ild Pituitary -Hot examined,missing Prostite -Prostititisa,cute,marked Spleen -malignantlyaphosa,histiocytic ------- -- -- -------------------------------------------- Species!Rat Project Number: 0291CROO12 Summarized STAR Page: 187 378 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year OralToxicity-OncogenicitSytudyin Rats Table:2 AnimalNumber: IR-3602 Sex: Male Group: 3) FN-392430 pps Fate: (Weekz106)TerminalSacrifice MicroscopicObservationslcontinued): Stomach Trichea UrinaryBladder -Ulcer -Tracheitisa,cute,sild -Epitheliahlyperplasiis,imple,diffuse, marked Cystitisa,cute,"rked Ulcer The followingtissues*erefoundto be withinnormallimits: Heart,Testis/EpididysiTsh,yroid,Parathroid,Esophagus,SalivaryGland,Pancreas. -- -------------------------------- - --- ---- ---- Animal Number: IR-3803 Sex: Nile Group:1 3) W3924 30 ppe Fite: (Week=106)TerminalSacrifice MacroscopicObservations: Pituitary Prostate MicroscopicObservations: Heart Kidney Liver Lung Parathyroid Pituitary Prostate Spleen Stomach UrinaryBladder -Raisedlesion,0.5 ce dia. -Edematous -Myocardialfibrosis,localareas,moderate 'i-Chtaniptrograisivenephropithy,moderate -Part&]manonativicrellinfiltrates,ild Portalbileductproliferationm,ild -Vasculaariwalization,sild Alveolareacrophileso,ulti4ocals,ild -Mt examined,notin plantof section -Adenm -Prostatitisa,cute,marked -Resosiderosism,ild -Bastritisa,cute,diffuse,moderate -Epitheliahlyperplasias,imple,diffuse, moderate Cystitisa,cute,diffuse,wild The followingtissueswerefoundto be withinnormallimits: Testis/EpididysisA,drenal,Thyroid,Trachea,Esophagus,SalivaryGland,Pancreas. ---------------------- - -------------------- Species:Rat Project Number: 0201CROO12 Sworized STAR Page: IBS 379 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3804 Sex: Kale 6roup: 3) FM-392430 ppe Fate:(Weeks 75) Sacrificeidn extresis MacroscopicObservatii)ns: Liver Kidney Nesentery Testis/Epididysis MicroscopicObservations: Heart Kidney Liver Lung Nesentery Pancreas Parathyraid Pituitary Prostate Spleen Testis/Epididysis -Pale -Pale,pittedand enlarged. -Nodularmosentericvessels. -Testesbilaterallsymall. -Nyocarditis,chronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropathy,marked -Hopatocytvoacuolitionl,ocalareas,sild -Vascularmintrilizatiosni,ld Hemorrhage,local areas,mild -Polyarteritism,arked -kinar atrophy,wild Polyarteritissi,ld -Hyperplasia,moderate -Adenna -Mt examined,missing -Hemosiderosism,ild -Tubuleatrophy,aspersatogenesism,oderate Polyarteritism,oderate The followingtissueswerefoundto be withinnormallimits: Stomach,Urinirylladder,Adrenal,Thyroid,Trachea,Esophagus,Salivary61and. ---------------------------------------------------------------------------------- AnimilNumber: IR-3805 Sex: Kale group: 3) FN-3924 30 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations: -No visiblelesions. MicroscopicObservations: .Adrenal -Corticaldegenerationf,ocal,mild Heart -Myocarditisc,hronicnonsuppurative, localareas,mild Kidney -Chronicprogressivenephropathy,mild Liver -Portalsononucleacrellinfiltratem,inimal Portalbileductproliferationm,ild HipatKyte vacuolationm,ild Negalocytosiss,ild Hepatocytealterationb,asophilico,ultilocal, sild Lung -Vascularmineralizationm,ild Perivasculasrononucleairnfiltratemlild ---------------- ---------- -- ---------------------- Species:Rat Project Number: 0291CROO12 9m arized STAR Page: 189 380 SummarizedSingleTabulatedAnisalReport (continued) IndividualMacroscopicand MicroscopicObservations Riker Laboratories,Inc. 3M FN-3924:Too Year Oral Toxicity-WcogenicitSytudyin Rats Table:2 Animal Number: IR-3805 Sex:Halt Fate: (Nnks 106) Terminal Sacrifice Group: 1 3) FN-392430 pps MicroscopicObservationstcantinued): Pancreas Pituitary -Isletcell adenosa -Adenoma The followingtissuesNero found to be withinnormal liaits: Spleen,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea, Esophagus,Salivary Blind. --- ----- --- ------- ---- ---------- - - --------- - ------------ Animal Number: IR-3806 Sex: Halt Fate: lneekz106) TerminalSacrifice Group: 3) FN-3q24 30 ppe MicroscopicObservations: Skin MicroscopicObservations: Adrenal Kidney Liver Lung Pituitary SalivarySland Skin -Raisedcircularin4lasud lesions,bothhind footpiids. -Sinusoidalectasia,cortex,diffuse,sild KWul1iirycallbyperplasia,focal,sild One of pairprntnt -Chronicprogressivenephropathy,sild -Portalsononucleacrell infiltrate,sild mnalacytosist minimal Hqmtocyte alteration,hasophilic,focal, mild -Vascularmineralizations,ild Perivmular mnonuclearinfiltrate,mild -Adenosa -Not examined,missing -Pododereatitisu,lcerative,bilateral,marked The followingiissutswere found to be withinnormallimits: Spleen,Heart, Testis/EpididysisP,rostate,Stomach,UrinaryBladder, Thyroid,Parathyraid, Trachea, Esophagus, Pancreas. Animal Number: IR-3807 Sez: Kale Fate: lneekz106) TerminalSacrifice Group: 3) FN-3924 30 ppe Macroscopic Observations: Kidney MicroscopicObservations: Heart Kidney -Ulceratedarea,0.7 co dia., right kidney. -Myocarditis,chronicnonsuppurativt, oultifocalm,ild -Chronicprogressivenephropthy, sild Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 190 381 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3q24:Tva Year Oral Toxicity-OncognicitSytudyin Rats Table:2 Animal Number: IR-3807 So: Nile Group: 3) FN-392430 pps Fate: (Neekz106)TerminalSacrifice RicroscopicObservations(continued): Liver Lung -Hepatocytveicuolationo,ultifocals,ild Hipatocytaelterationv,acuolatedslultifkal, mild Regalocytosiss,ild -Vascularmineralizationm,ild The followingtissues*erefoundto be withinnormallimits: Spleen,Testis/EpididysiPsr,ostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,SalivaryBlind,Pituitary,Pancreas. AnimalNumber: IR-3609 Sex: Kale Group: 3) FN-392430 pps Fite: (Weekz106) TerminalSacrifice MacroscopicObservations: Pituitary Liver MicroscopicObservations: Adrenal Heart Kidney Liver Lung Pituitary Thyroid -Smallraisedmass,0.4 ce dia. -Largemass,5 1 3 1 2 ce, in ndian lobe. -Corticalvacuolationd,iffuse,moderate -*K arditis,chroniciion'suopurati@e, oultifocals,ild -Chronicprogressivenephropathy,aild -Portalsononucleacrell infiltratem,ild Portalbileductproliferationm,ild Cystoiddegenerationf,ocal,mild Hyperplasticnodule -Vascularmineralizationm,ild Perivasculasrmonuclearin4iltratim,ild Hyperplasiis,eptalcell,focal,moderate -Adenosa -C cell adenosa The followingtissueswerefoundto be withinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,ParathyraidT,rachea,Esophagus, SalivaryGland,Pancreas. ------------- --- ------- ------------------------------------------------ --------- - Species:Rat ProjitctNumber: 0261CROO12 Summarized STAR Page: 191 382 SuuarizedSingleTabulatedAnimalReport(continued) IndividualMicroscopicand HicroscopicObservations RikerLaboratoriesI,nc. 3N W3924: Tvo YearOral Yoxicity-OncogeniciSttyudyin Rats Table:2 AnimalNumber: IR-3609 Sax: Kale Broup: 3) FN-392430 pps Fat#: (koks 70) Sacrificedin extresis MicroscopicObservations; Skin Eye MicroscopicObservations: Adrenal Eye Liver Lung Pancreas Parathyroid SalivaryGland Skin UrinaryBladder -Mass,3.5 ce dia.,containinggrey-yallom caseousexudate,right lateralhead. -Righteye atrophiedmith cornealulceration, red exudate aroundeye. -kt examined,missing -Keratitisa,cute,unilateralm,arked Large,perforatedcornealulcer. -Portalmononucleacrellinfiltratem,ild Nepatocytevicuclationo,ulti4ocal,mild 14alocytosis,minimal -Vascularmineralizationm,ild Perivasculaarmonuclearinfiltratem,ild Metastaticneoplasm -kinar atrophy,moderate -kt examined,notin planeof section -Atrophy -Squamouscell carcinoma,head .-.PAwrldyifferentiatm4u,lceratedvith extensivenecrosisi;nfiltrative. -Not examined,missing The folloning tissues mere fckmd to be vithin normal limits: Spleen, Kidney, Heart, Testis/Epididysir,P,rostate, Stomach, Thyroid, Trachea, Esophagus, Pituitary. ----------------------- - ------ Animal Nuaber: IR-3810 Sex: Nale Broup: 3) FN-3924 30 ppe Fate: (Weeks 99) Sacrificedin extresis Macroscopic Observations: Pituitary Skin Microscopic Observations: Adrenal Kidney Liver Lung --- --- --- - --- -- - ---- -- -- -Raised dark mass, I ce dia. -Ulceratedright hind footpad. -Sinuscidalectasia,cortex, diffuse, sild -Chronic progressive nephropathy, sild -Portal sononuclearcell infiltrate,mild Repatacytevicualation,sultifocal,mild Regalocytosis, minimal -Vascular mineralization Alveolar eacrophages,@Ulti#Kll, sild Perivascularsononaclearinfiltrate,sild -------------------- ----- Species: Rat Project Nwiber: 0201CROO12 Summarized STAR Page: 192 383 Sumarized SingleTabulatedAnimalagport-icontinugd) IndividualMacroscopicand Microscopicobservations RikerLaborstoriegIgnc. 3N FO-3924:Two VtoarOralToxicity-bcogenicitSytudy in Rats Table:2 Anisal Number: IR-3610 Sex:Nile Group: C 3) FN-3124 30 ppe Fate:(Weeka") Sacrificeidn extresis MicroscopiOcbservations(continued): Pituitary Skin -Adenoma -Padodermatitiusl,cerativeL,militeral, marked The followintgissueswe foundto be withinnormallimits: Spleen,Heart,Testis/EpididysiPsr,ostate,Stomach,UrinaryBladder,Thyroid,Parathyraid, Trachea,Esophagus,SalivaryBland,Pincress. ------- -- -------------------------------------------------------------------- Animal Number:IR-4821 Sex: Female Group:i IV)FK-392430 pps Fate:lneekt B3iFoundDead MicroscopicObservations: Pituitary micfoscopiocbservations: Adrenal Kidney Liver Lung Ovary Pituitary Spleen Uterur., -Hemorrhagimcass,I x 0.6to. -Sinuscidaelctisia,cortex,moderate Nodularhmrplasia, cortex,mild Corticaldogearation,mild -Chronicprogressivneophropithym,inimal Pelvicsintralizatiomni,nimal -ftpatocytveicurlatioraiu,'Atifocaslisl,d -Vasculasrintralizatiomni,ld Edosa,aild -Tubularhyptirplasibai,lasteramli,ld -Adenoa; -Weacsiderosisi,ld -kri'eLxamined, missing Thefollowingtissues*erefoundto be withinnormall&aisits: Heir4lP.a,rearyBlind,S'6o@achU,rinaryBladder,Thyroid,ParathyroidT,rachea,Esophagus, Si!4@viryglain4.P,ancreas. ------------------------------------------------------------------------------------ An-&'a&N,umber: IR-421.2 get: Female Sroup: 13) FO-3924'JOppe Fi'Le:(Neekz104)Sacrificedin extres4.s MicroscopicObservations: Pituitary -Raisedmass,0.5ce dia. KagairyBlind -Hemorrhagicn,ecroticmass,3 1 2 ce, in thL, Liver pectoralarea. -Scatterepdalefoci. Spleen -Possiblyenlarged - ---------------------------------------------------------------- t4QDtnc-A.)At.WttCtosec:,,oM i:*scotv*-r7oA.) ff*IE .40r*X>,At# AID 7-TS S Lt& I-r.,136 7W-,@-,aAJ Species:Rat Project Number: 0281CROO12 SummarizedSTAR Pa;#: 193 384 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObwvations RiterLaboratoriesI,nc. 3K FN-3924:Two Year OralToxicity-bcogenicitSytudyin Rats Tiibtl: 2 Animal Number: IR-4822 Six:Female Group:t 3) FN-392430 ppe Fate:(Weeks104)Sacrificeidn extresis MicroscopiOcbservations(continued): Adrenal Kidney Liver Lung Mammary Gland Pituitary Spleen Uterus -Corticalvacuolations,ild Sinusoidalectasia,cortex,moderate -Pelvicsintralizatiosni,ld Hyperplasi,pie,lvicepitheliump,apillary, moderate -Necrosis,localareas,moderate Negatopciesise,xtra&Wullary,mild -Perivasculasronanucleairnfiltrates,ild Hmorrhage,local areas,mild -Adenocarcinosap,apillary -Adenoma -Nomatopoissise,xtrasedullaryi,ncreased, marked -Not examined,missing The followingtissueswere foundto be withinnormallimits: Heart,Ovary,Stomach,UrinaryBladder,Thyroid,Parithyraid,Trachea,Esophagus, SalivaryGland,Pancreas,Eye. - ------------------------------------ Animal Number: IR-4623 Sax: Fosele Group: 3) FN-392430 pps Fite: (Weeks105)TerminalSicrifice MacroscopicObservations: Pituitary Naaary Gland MicroscopicObservations: Adrenal Kidney Liver Lung Mammary Bland Parathyraid Pituitary SalivarySland Thyroid -Nis&,0.4 ce dia. -Lobularmass,7.5 1 5 x 2.5 ca, throatarea. -Sinusoidielctisia,cortex,marked -Pelvicsintralizatiomni,nimal -Nepatocytovacuolationa,ultifocalm,inimal Nepatacytealterati-ovna,cualated,sild -Vascularminerilizatiosni,ld Alveolareacrophages,focal,minimal Nmrrhage, localareas,mild 4ibroadenoma -Not examined,not in planeof section -Adenocarcinona -Not examined,missing -Adenocartinamaf,ollicular The followingtissueswe foundto be mithinnormallimits: Spleen,Heart,Uterus,Ovary,Stomach,UrinaryBladder,TrachoilEsophagus,Pancreas. -- ------------- ---- - ------------------------------ Species:Rat Project Number: 0281CROO12 &wgarized STAR Page: 194 385 Summarized 9ingleTabulatedAnimalReport(continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-OncogeniciSttyudy in Rits Table:2 AninalNumber: IR-4824 Set: Female Group: 3) FN-392430 ppe Fate:(kok- 102)Foundkid MicroscopicObservations: Mammary Gland MicroscopicObservations: Adrenal Liver Mismary Gland ovary Pancreas Parithyroid Pituitary SalivaryGland Skin Spleen Thyroid Urinary$ladder -Miss,9 s 6 1 1.5ce, inguiniialrea;mass,6 1 6 K 5 ce, rightaxillaryarea, ulceratedand bleeding. -Sinusaidaelctasiiic,ortex,mild Adenomilcortical -Necrosis,clmtrilobularm,arked -Fibroadenon -Cyst -Not examined,missing -Not examined,missing -Adencea -Not examined,missing 4ibroma -Mustopoissis,extramedullaryi,ncreased, Bild -Not examined,missing -Not tiaisinedmlissing The followingtissueswere foundto be withinnormal limits: Kidney,Heart,Lung, Uterus,Stomach,TrachealEsophagus. ------------ AnimalNumber:IR-4M So%: Fmle Group: 3) FN-392430 ppa Fate:(keeks102)Sacrificedin extresis MacroscopicObservations: Pituitary Rastary Gland MicroscopicObservations: Adrenal Esophagus Kidney Lung Rammry Gland Pancreas Pituitary SalivaryBliind Uterus -Raiseddark mass,1.2 co dis. -Massin perinialarea;appearsto be inflanedmilkcyst. -Sinuscidaelctisia,cortex,mild -Not examined,missing -Chronicprogressivenephropathy,mild -Yascularmineralizationm,ild Alveolareacrophageso,ultifecal,mild -salactecole Labularhyperplasia -Acinaratrophy,sild -Adenoss -Not asaained,missing -Not examined,missing - ----------- species:Rat ProjectNumber:OnIM0012 Summarized STAR Page: 195 386 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H Ffl-3924T:oo YeAr OralToxicity-OncogeniciSttyudyin Rats Table:2 AnimalNumber: IR-4825 Six: Female Group:t 3) FN-392430 ppe Fate:(Neeka102)Sacrificeidn ntresis MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits: Spleen,Liver,Heart,Ovary,Stomach,UrinaryBladder,Thyroid,Parithyroid,Trachea. ----------- - -------- ---- ---- Animal Number: IR-4826 Six: Femile group: 3) FN-392430 ppe Fate: (Weekz105)TerminalSacrifice MicroscopicObservations: Mammary Sland Pituitary MicroscopicObservations: Adrenal Heart Kidney Liver Lung Naseary Bland Oviry Pituitary Spleen Thyroid -Mass,3 s 2 ce, throatarea;mass 3 ce dia., leftaxillalsmallmilkcyst, rightasills. -Raiseddarklesion,0.7 ce dii. -Sinusoidalectasia,cortex,marked -Myocardiaflibrosis,oulti4ocalm,ild Nyocarditis,chronicnonsuppurative, oultifocalmlinimal -Pelvicmineralizationm,inimal -HIPItKYtevacualitiono,ultifocalm,inimal -Yascularmineralizations,ild Alveolareacrophageso,ultifocal,mild -Fibroadenou Adenocarcinotat,ubular salictocall -Tubularhyperplaisibai,laterals,ild -Adenosa -koosiderosiss,ild -Hyptfpl&Sia, C Ctll, fk&ll sild Ultimbranchialcyst The followingtissueswerefoundto be withinnormallimits: Uterus,Stomach,UrinaryBladder,Parathyroid,Trichea,Esophagus,SalivaryBland,Pancreas. - -- --- --- --- - Anisal Number: IR-4627 Six: Female Broup: 3) FN-392430 ppe Fate:(Inks 105)TerminalSacrifice NacroscopicObservations: Mammary Blind Pituitary MicroscopicObservations: Adrenal ------------ -Firsmass,1.5ce dia.,throitarea. -Mass,0.7 co dia. -Cortical degeneration,local artis, vild Species:Rat Project Number: 0281MOO12 Summarized STAR Page: 196 3o0 i7 Swmarized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Tva Year OralToxicity-ftcogeniciSttyudy in Rats Table:2 Animal Number: IR-4627 Sex:Fmlt Group:1 3) FN-392430 pps Fate: (Veeks105)TerminalSacrifice MicroscopicObservationslcontinued): Heart Kidney Liver Lung Mammary Bland Ovary Pituitary Uterus -Nyocarditisc,hronicnonsuppurative, sultifocalm,ild -Chronicprogressivenephropathylminimal Pelvicmineralizationm,ild -Portalsonanucivickarll infiltrates,ild PortalbiledKt proliferations,ild Repatocytevacualitiono,ultifocal,minimal Hopatocytoalteration,vacuolatedm,ild -Vascularmineralizationm,inimal -Adenocarcinoma -Nithinnormallimits One of pair present -Adenona -Cysticglands,marked The followingtissueswere foundto be withinnormallimits: Spleen,Stomach,UrinaryBladder,Thyroid,Parithyroid,Trachea,Esophagus,SalivaryBland, Pancreas. Animal Nuaber: IR-4628 Sex:Fmlt Group: 3) FN-392430 pps Fate:tneeks95) Sacrificeidn extresis MicroscopicObservations: Pituitary Kaosary Gland MicroscopicObservations: Adrenal Heart Kidney Liver Lung Rasury Bland Parathyraid Pituitary Thyroid Uterus -Hemorrhagimciss, 1.4 1 0.8 ce dia. -Smallmass,2.41 2 x I ce dia.,right axilla. -Sinusoidaelctasia,cortex,moderate -Myocardiaflibrosis,oultifocalm,ild -Chronicprogressivenophropathyf,ocal,sild -*itocyte vacuolationcgontrilobulasri,ld -Vascularmineralizations,ild Alveolareacrophagess,ultifocal,mild Hemorrhage,localareas,sild -Fibroikdenomi -Not examined,missing -Adenm -Not examined,missing -Cysticglands,moderate The followingtissuessere foundto be withinnormallimits: Spleen,Ovary,Stomach,UrinaryBladder,Trachea,Esophagus,Salivary61and,Pancreas. Species:Rat Project Number: 02BICROO12 Summarized STAR Page'.197 388 Swaarized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Tmo Year OralToxicity-OncoginicitSytudyin Rats Table:2 Animal Number: IR-4829 Sax: Female Group: 3) FN-392430 ppe Fate: (Neekz103)TerminalSacrifice MacroscopicObservations: Skin Adrenal NicrescapicObservations: Adrenal Heart Kidney Liver Lung Mammary Bland Resentery Ovary Pancreas Pituitary -Hairlossm forelegs. -Rightadrenalinvolvedin a mass,3 x 2 ca; left adrenalenlarged. -Sinuscidalectasii,cortex,marked Pheachrosocytou,malignant,unilateral -Myocardiaflibrosis,localareas,sild Myocarditiz,chronicnonsuppurative, localareas,aild -Chronicprogressivenephropathy,moderate Pelvicmineralizationm,oderate -Hepatocytovacuolationo,ultifecal,minimal -Vascularmineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, sild Ptrivasculaarnonuclearinfiltrates,ild Hemorrhage,oultifocal,mild -salactoctle -Leiomyosarcoma Tumornot describedgrossly. Highly anaplastic. -Tubularhyperplasiam,ild -Not examined,missing -Adenou The followingtissueswere foundto be withinnormallimits: Spleen,Uterus,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea,Esophagus, SalivaryGland,Skin. -------------- ----------Animal Number: IR-4830 Sex: Female Group: 3) FN-392430 ppe Fate: (Weeks105)TerminalSacrifice MacroscopicObservations: Pituitary Mammary 61and Uterus -Smalldarklesion,0.2 co dia. -Hass,2.5 1 1.3ce, rightaxilla;cystic mass,5 1 4 x 2.5 ce,rightinguinal. -Hemorrhagiccysticlesion,2 1 1.3to, right horn. MicroscopicObservations: Adrenal -Corticaldegenerationf,ocal,sild Kidney -kpbrosis,tubular,marked -- ---- ------------- --- ------------------- Species:Rat Project Number: 0281CROO12 SummarizedSTAR Page: 1" 389 SummarizSeidnglTeabulatAendimaRleport(continuW)IndividRuaaclroseoapnidcNicroscoOpbiscervations RikerLaboratoriIensc,.3" FN-3q24T:woYearOralToxicity-OncogenSitcuidtyiynRiits Table:2 AniailNumber:IR-4830 Sex: Female group: 3) FN-392430 ppe Fate: (*eks 105)TerminalSacrifice NicroscapiOcbservations(continued): Liver Lung Nameary Sland Parithyroid Pituitary Uterus -Portalsonanucleacrellinfiltrates,ild Portalbile ductproliferationm,ild Nepitocytevacuolitiono,ultifocalmlild -Pneumoniai,nterstitialc,hronic,oultifocal, mild PerivasculaDrononucleiirnfiltrates,ild -Fibroadenosa -Notexamined,not in planeof section -Adenoma -Polyp The followingtissueswerefoundto be withinnormallimits: Spleen,Heart,Ovary,Stomach,Urinarygladder,Thyroid,Trachea,Esophagus,SalivaryBland, 'Pancreas. -------------------------- --- ----------- --- AniaalNueber: IR-4831 Sex: Female Group: 31 FN-3924 30 ppe Fate:(Weekz 96) Sacrificeidn extresis NacroscopicObservations: Pituitary NicroscapicObservations: Adrenal Kidney Liver Lung Pituitary ..SalivaryBland Spleen -Hemorrhagiecass,I ce dii. -Sinusaidalectisia,cortex,sild -Pelvicmineralization,mild -Nepatocytevacualation,oultifocal,minimal Pigeent,brown,local areas,mild -Vascularmineralizationm,ild Pneumonia,interstitial,chronic,oultifocal, mild Hemorrhage,oultifocals,ild -Adenon -Hemorrhage -Neeasiderosis,moderate The followingtissueswere foundto be withinnormallimits: Heart,Uterus,Ovary,Naseary61and,Stomach,UrinarySladder,Thyroid,ParathyroidT,rachea, Esophagus,Pancreas. --------------------------------------------------- ------------ SpeciesR:at ProjecNtumber0:261CRO12 SummarizSeTdARPage:1" 390 guwwized SingleTabulatedAnimalReporttcantinued) ledividuikMlacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FIF3924:Too Year OralToxicity-OncoginiciSttyudyin Rats Table:2 Animal Number: IR-4832 Sax: Female Broup: 3) W3924 30 ppe Fate: (Ints 105)TerminalSacrifice MicroscopicObservations: Ovary MicroscopicObservations: Adrenal Esophagus Liver Lung Ovary Parithyroid Pituitary SalivaryBlind Thyroid Trachea -Smallnodularmass,0.0 ce dia.,leftovary. -Sinusaidaelctasia,cortex,sild -Not examined,missing -Repatocytvoicuclationo,ultifocalslild NeQAIKytOSiS, sild -Vascularmineralizations,ild Pneumoniai,nterstitialc,hronic,sultifocal, sild Alveolarmacrophigess,ultifocals,ild -Tubularadenosa -Not examined,missing -Adinm -Not examined,missing -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Spleen,Kidney,Heart, Uterus,MammarySland, Stomach,Urinary Bladder,Pancreas,Eye. - -- --- --- - AnimalNumber:IR-40 Sex:Fesile Group: 1 3) FN-392430 ppe Fate: (Weekz 86)Sacrificeidn extresis MicroscopicObservations: Ramairy Bland Liver MicroscopicObservations: Adrobal Kidney Ling Mammary Gland SPIM -Largeaass, 15 1 12 s 3 co, ulcerated surface,inguinalarea. - -Appearsenlarged -Corticalvacuolationf,ocal,mild Sinusaidalectasia,cortex,marked -Pelvicmineralizatiomni,niul -Vascularmineralizationm,ild Pneumonia,interstitialc,hronic,oultifocal, sild Alveolarmacrophageso,ultifocal,mild -Fibroadenosa -Hmtopoitsis,extrasedullaryi,ncreased, moderate The followingtissueswe foundto be withinnormallimits: Liver,Heart,Uterus,Ovary,Stomach,UrinaryBladder,Thyroid,Parathyroid,TracktalEsopkagus, SalivaryBland,Pituitary,Pancreas,LymphNode (wsenteric). Species:Rat ProjectNader: OnICRO12 SummarizedSTAR Page: 200- 391 SumarizW SingleTabulatedAnimalReport(continved) IndividualMacroscopicand MicroscopicObservations kiku LaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-WcogenicitSytudyin Rats Table:2 AnimalNumber: IR-46M Six: Female group: 3) FN-392430 ppe Fate: (koka 105) TerminalSacrifice MacroscopicObservations: Haseary Bland MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Hiseary Gland Pancreas Pituitary Thyroid-- -Lobulatedmass,6.5 1 5 x 3 cap right inguinalarea. -Corticavlicualitionf,ocal,mild Sinuscidalectasia,cortex,mild -Not examined,missing -Pelvicmineralizationm,inimal -Portalsononucleacrellinfiltrates,ild Htp&tKytt alterationv,accolatedo,ultifocil, sild Portalbileductproliferatiomni,ld -Vascularmineralizations,ild Pneumonia,interstitialc,hronic,BUItifKal, mild Alveolarucrophages,sultifociisli,ld -Fibroadenosa -Not examined,missing -No diagnosis,inadequatesection -C call carcinoma'. The follamingtissues*erefoundto be withinnormallimits: Spleen,Heart,Uterus,Ovary, Stomach,UrinaryBladder,Parathyroid,Trachea,SalivaryBlind. ------------------------- ---------- ---- -- - Animal Number: IR-4835 Sax: Female Group: 3) FN-392430 pps Fate: (Week=105)TerminalSacrifice MicroscopicObservations: MicroscopicObservations: Adrenal Liver Lung Pancreas SalivaryBland Thyroid -No visiblelesions. -Sinusoidalectisia,cortex,moderate -Hopatocytevacuolationo,ultifocal,mild H@P&tKytt alterationv,acualated,oultifocal, mild -Vascularmineralizationm,ild Hemorrhage,UltifK&I, sild -Not examined,missing -kt examined,missing -HyperplasiaC,cell,oultifocalmlinimal The followingtissueswere foundto be withinnormallimits: Spleen,Kidney,Heart,Uterus,Ovary,Rasury Bland,Stomach,UrinaryBladder,Pwithyroidl Trachea,Esophagus,Pituitary,LymphNode (sesenteric). ------------- --- -------------------------- Species:Rat Project Number: 02$ICROO12 SummarizedSTAR Pap: 201 392 Sumarized SingleTabulatedAnimal Report (continvw) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-4836 Sex: Fettle Group: 3) FN-392430 pps Fate:(Nffk-105)TerminalSacrifice MacroscopicObservations: Eye Nauary Bland MicroscopicObservations: Eye Liver Lung Hiseary Gland Ovary Pituitary Skin UrinaryBladder -Opacity,righteye. -Sphericalnodule,I ce dia.,perintalarea; mass,11.51 li 1 2.5 ce, left lateralarea. -Cataract,unilateral Retinalatrophy,diffuse,unilateralm,arked -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld Repatocytoalteration,vacuolated,focal, mild -Yascularsineralizatiosni,ld Alveolarmacrophages,mild Hemorrhage,wltifocal,mild -Adenotareinna -Tubularhyperplasiab,ilateral,marked -Noteximinwo missing -Lipati -Not examined,missing The followingtissueswortfound to be withinnormallimits: Spleen,Kidney,Heart,Uterus,Stomach,Adrenal,Thyroid,Parathyroid,Trachea,Esophagus, SalivaryGland,Pancreas. --- --------------------------- - --- ---------- -- ----------------- Animal Number: IR-4037 Six: Female Group: 3) W3924 30 ppe Fate: tkekz 87) FoundDead N,icroscopiOcbservations: MicroscopicObservations: Kidney Liver Lung Pituitary SalivarySland UrinaryBladder -No visiblelesions. -Pelvicsineralizatioani,ld Hyperplasiap,elvicepitheliues,ild -Portalsoftonuclecaerllinfiltratem,ild Portalbileductproliferationm,ild Repatocytveacualationo,ultifocals,ild -Yascularsinerilizatiomni,ld -Not examined,missing -Not examined,missing -Not examined,missing The followingtissueswe foundto be withinnormallimits: Spleen,Heart,Uterus,Ovary,NiieuryBlind,Stomach,Adrenal,Thyroid,ParathyraidT,rachta, Species:Rat ProjectNumber:OnICM12 Suourized STU Page: 202 393 SummarizedSingleTabulatedAnimalReport lcontinued) IndividuaMlicroscopiacnd NicrescopiOcbservations RikerLaboratoriesI,nc. 3N FN-3924:Too Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 AnimalNumber: IR-4837 Sax: Female Group: 3) FN-3q2430 ppe Fate: lneek--U) FoundDead MicroscopicObservationstcontinued): The followingtissueswe foundto be withinnormallimits(continued): Esophagus,Pancreas,Small Intestine. -------------------------- ----------- Animal Number: IR-4638 Sex: Female Broup: 3) Ffl-392340 ppe Fite:(Week-99) Sacrificeidn extresis MacroscopicObservations: Pituitary Spleen Liver Rassary Gland MicroscopicObservations: Adrenal Kidney Liver Lung Mammary Bland Pancreas Parithyraid Pituitary Spleen Thyroid -Enlarged -Enlarged -Palo -Mss, 3.5 1 1.5ca, oultilobularp,erineal area;ulceratedoultilobulamrass, 6 x 5 x 4 ca, rightliteralarea. -Sinosoidalettasia,cortex,moderate -Pelvicmineralizationm,inimal Nephrnis,tubular,sild -Hmtopoirsis,extratedullarym,inimal -Vasculasrineraliziti=,'iiil'if', -Adenocarcinceatlubular Adenocarcinna,papillary -Not examined,missing -Not examined,missing -Adenosa -Hematopoitsite,xtraeedullaryi,ncreased, marked -Not examined,missing The followingtissuesmere foundto be withinnormallimits:- Heart,Uterus,Ovary,Stomach,UrinaryBladder,Trtchea,Esophagus,SalivaryBland,Eye. --- --- ------- --- --- - - ---------------- Animal Number: IR-483q Sex: Female Group: 3) W3924 30 ppe Fate:(kekm 105)TerminalSacrifice MacroscopicObservations: Skin MicroscopicObservations: Adrenal Kidney Liver -Hair lossan forelimbs. -Sinusoidalectasiiic,ortex,moderate -Chronicprogressivenephropathy,minimal Pelvicmineralizationm,ild -"ePAtOCYteVACUOI&tiOR,UltifK&I, mild Species:Rat Project Number: 0201CROO12 Summarized STAR Page: 20@ 394 gunwizeSdinglTeabulatAendiulRepor(tcwtiuuld)ladividualNacroscapicand MicroscopicObservations RiktrLaboratoriesI,nc. 3H FN-3924:Too Year OralToxirity-WcogenicitSytudyin Rats Table:2 AnimalNumber:IR-4639 Six:Fault Group:t 3) FN-392430 ppe Fate:(Neekz105)TerminalSacrifice MicroscopiOcbservation(scontinued): Lung Ovary Parithyroid Pituitary UrinaryIladder -Vasculasrineralizatiosni,ld -Tubularadenosa -Nottxaainedn,ot in plantof section -Adenoma -Not examined,missing Thefollowintgissuesserefoundto be withinnorul limits: Spleen,Heart,Uterus,MammaryGland,Stomach,Thyroid,Trachea,Esophagus,SalivaryGland, Pancreas,Skin. AnimalNumber:IR-4640 Six:Fatale Group: 3) FN-392430 ppe Fate:igeekx93) Sicrifictidn extresis MacroscopicObservations: Pituitary Thorax(internal) Liver Vagina MicroscopicObservations: Adrenal Heart Kidney Liver .Lung LymphNode (thoracic) Missiry61&nd Ovary Parathyroid Pituitary SPIM Uterus -Appearssomewhatenlarged. 4&tty tuw-like &ass,2 1 2 ca,inanterior thorax. -Paleand mottled. -Polypoidmass,ulceratedsurface,3 a 1.5ce, attachedto cervix,prolapsintgo outside. -Necrosisd,iffuse,unilateralm,arked -Myocardiaflibrosisl,ocalareas,sild -Dronic progressivneephropathym,inimal Pelvicsintralizatiomno,derate -Portalsononucleacrallinfiltratem,inimal Portalbileductproliferatiomni,nimal Repatocytveacuolitionl,ocalareas,sild Hes&tDpoitsise,xtramedullarym,inimal -Vasculasrineralizatima,ild -Lymphosarcosa -Notexamined,missing -Tubularhyperplasiau,nilaterals,ild -Notexaminedn,ot in plantof section -Adenomi -Hosatopoitsiesx,trasedullaryi,ncreased, moderate -Polyp Tumor&risingfromcervix. Waco awatic and ulcerated. Specits:Rat Project Number: 0261CROO12 Somarized STAN Page: 204 395 Smarized SingleTabulatedAnimalReport(continved) Individualkerokopic and NierescopicObservations RikerLaboritoriesIgnc. 3K FN-3924:Too Year Oral7oxicitroncogenicitSytudy in Rats Table:2 Animal Number: IR-4840 Six: Female Group: 3) FN-392430 ppe Fate:(Neeks93)Sacrificeidn extruis MicroscopicObservations(continatid): The followingtissueswere foundto be withinnormallimits: Stomach,UrinaryBladder,Thyroid,Trachea,Esophagus,SalivaryBland,Pancreas, LymphMode (sesenteric). ---------@--7---------------------- ---- --- - - --- --- --- Animal Number: IR-4641 Sex: Female Group: 3) FN-392430 ppe Fate:(Neekz101)Sacrificedin extresis MacroscopicObservations: Mammary 61and Adrenal Liver Pancreas Abdomen (internal) LymphNode (sesenteric) Uterus MicroscopicObservations: Adrenal Kidney Liver LymphNode (sesenteric) Mammary Bland Pancreas Pituitary Stomach UrinaryBladder Uterus -Subcutaneouusss, 4.5 1 3 s 2 ce, right alilia. -Left adrenalmlarged. -Palo -Rultilebulatehdemorrhagicmass,4.5 1 3 1 3.5 ce, in areaof pwreas involving the caudateliverlobe. -Filledwithbloodyfluid. -Enlarged 4altilobularcysticmass,5 x 5.51 2.5ce, near cervix. -Sinusaidaelctasia,corttx;'WkedMalignantlymphoss,histiocytic -Chronicprogressivenephropathy,mild -Portalbileductproliferationm,inimal -Malignantlymphou,histiocytic -Lobularhyperplasia -Malignantlymphosa,histiocytic -Not examined,missing -Ulcer Malignantlysphosa,histiocytic -Malignantlyaphosa,histiocytic -Cysticglands,mild Malignantlyaphoma,histiocytic Thefollowingtissuesare foundto be xithinnormallimits: Splm, Heart,Lung,Ovary,Thyroid,ParathyraidT,rachea,Esophagus,SalivarySland. Species:Rat ProjectWar: 0281CROO12 SummarizedSTAR Pap: 205 396 SummarizedSingleTabulatedAnimalReport (tantinued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Yoxicity-OncogeniciSttyudyin Rats Table:2 Anisal Number: IR-4842 Sex: Fatale Group: 3) FN-392430 pps Fate: (Weekz105)TerminalSacrifice MacroscopicObservations: Skin Pituitary Mammary Gland MicroscopicObservations: Adrenal Kidney Liver Lung Hasaary Bland ovary Pancreas Pituitary Skin Thyroid -Raisedinflammatorylesioncm rightkind footpad. -Mass,0.7 co dia. -Lobularmass,2.5 1 2 ca, leftinguinalirta; labularmass,3 x 2 es,right inguinalarea;lobular&ass,6 x 5 x 3.5 ca, rightaxilla. -Sinuscidalectasia,cortex,marked -Pelvicaintralizatiomni,nimal -Portalsmonuclearcallinfiltratem,inimal Portalbiledrctproliferatioani,nisal -Yascularmineralizations,ild Hemorrhage,diffuse,marked -Fibroadonoma Fibroadenua Fibroadenoss -Tubularhypirplasiab,ilateral,moderate -Acinaratrophy,marked Islet cell adenoss -Adenoma -Pododerutitisu,lcerativeu,nilateral, marked -HyperplasiaC,call,focal,mild The followingtissueswe foundto be withinnormallimits: Spleen,Heart,Uterus,Stomach,UrinaryBladder,Parathyroid,Trachea,Esophagus,SalivaryBland. --- ------------------ ---------- --- ----------- --Animal Number: IR-4843 Sex: Female Sroap: 3) FN-392430 ppe Fate: (Meek= 85) FoundDead MicroscopicObservations: Pituitary Ranary Oland MicroscopicObservations: Adrenal Liver Lung Pancreas Parathyroid - -Circularraisedmass,0.0 ce dia. -Smallsilkcystin inguinalarea. -Sinusoidaalctasia,cortex,marked -Portalsonanucleicierllinfiltratem,ild Portalbiltductproliferatiosni,ld -Yascularmineralizationm,ild -Not examined,missing -Not examined,missing ---------------- Species:Rat Project Number: OnICROO12 &mwized STAR Page: 206 397 quourizedSingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesIlnc. 3H FN-3924:Two YearOralToxicity-OncoleniciStyudyin Rats Table: 2 Animal Number: IR-4843 Sex: Female Group: 3) FN-3924 30 ppe Fate: lnnka 85) FoundDead MicroscopicObservationslcontinued): Pituitary SalivaryGland Spleen Stomach Thyroid Trachea -Adenosa -Not examined,missing -fteosiderosism,oderate -Not examined,missing -Mt examined,missing -Not examined,missing The follouingtissues*erefoundto be withinnormallimits: Kidney,Heart,Uterus,Ovary,MammaryGland,UrinaryBladder,Esophagus. Animal Number: IR-4644 Be%: Female Group: 3) Fli-392340 pps Fate: (Weekz105) TerminalSacrifice NacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Lung Ovary Pancreas Parathyroid Pituitary Thyroid -Raiseddarkons, 0.7 ce dii. -Sinusaidiekcltasii,cortex,mild -Chronicprogressivecephropathy,mild -PerivascuUmrmoKlow!Wiltrate, wild -Cyst,unilateral -Not examined,missing -Not examined,missing -Adenm -Not examined,missing The folloningtissueswere foundto be Nithinnormallimits: Spleen,Liver, Heart,Uterus, MammaryGland,Stoaach,UrinaryBladder,Trachea,Esophagus, SalivaryGland. ------------------ - ---------- A-,iisaNlumber: IR-4645 Sex: Female Sroup: 'VIF)N-3924 30 pps Fate:(Week- 84)Sacrificeidn extresis MacroscopicObservations: Pituitary Liver MicroscopicObservations: Adrenal Liver Lung -Raisedmass,0.7 ce dis. -slightlyPalo -Cortical degeneration, IK31 areas, moderate -Portalsononucleacrtllinfiltratew,ild Portalbile ductproliferationm,oderate HIP&tKYte vacuolation,diffuse,moderate -Yascularmineralizationwgild Species:Rat ProjectNumber:OnICM12 WuarizW STAR Page: 207 398 SumariztdSingleTabulateAdnimalReport(cwtinutd) IndividualMicroscopicand RicroscopicObservations RikerLaboratoriesI,nc. SN FN-3924:Too Year Oral Toxicity-OncogeniciSttyudyin Rats --- --- -- -Animal Number: IR-4045 Sex: Female Broup: 3) FN-392430 ppe Fate:(Wkz 84)Sacrificeidn extresis Table:2 MicroscopicObservation(scontinutd): Pancreas Pituitary -Not examined,missing -Adenosa The followingtissueswere foundto be withinnormallimits: Spiten,Kidney,Heart,Uterus,Ovary,MammaryBland, Stomach,Urinarygladder,Thyroid, PirithyroidT,rachea,Esophagus,SalivaryBland,LymphNode (Wstnteric). ---- -- ---- - - --- -- AnimilNumber: IR-4846 Sex: Female Group: 3) FN-3q2430 pps Fate: (Week= B4) FoundDead MicroscopicObservations: Pituitary Hasaary Sland MicroscopicObservations: Adrenal Kidney Liver Lung Mammary Gland Pancreas Pituitary Spleen Thyroid -Largehemorrhagicmass, 1.2 s I ce. -Nultilabulimrass,2.5 1 1 ce,perintalarea. -Sinusoidailttisia,cortex,minimal One of pair present -Pelvicmintraliziitisoinl,d -Portalsononscleacrellinfiltratem,ild Portalbileductproliferatiosni,ld -Vasculasrimraliziitiosni,ld -Fibroadenama -Not examined,missing -Adenooi -Hemsiderosis,mild -Ultisobranchicaylst The followingtissueswerefoundto be withinnormallimits: Heart,Uterus,Ovary,Stomach,UrinaryBladder,Parathyroid,Trachea,Esophagus,SalivaryBland. --- --- --- --Aniaal Number: IR-4047 Sex: Female Group: 3) FN-392430 pps Fate:(Week=105)Sacrificedin extresis MacroscopicObservations: Heart Adrenal Kidney MicroscopicObservations: Adrenal --- -- --- --- -- -- - -Possiblepericarditis -Loftadrenalenlargeddue to mass,1.5 ce dia. -Appearpitted -Carcinomac,ortical,unilateral Corticalatrophy,unilateral,marked Atrophyin non-neoplistigcland. - --------------- Species:Rat Project Number: 0281CROO12 &muized STAR Page: 20ow 399 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations RikerLtboratoriesI,nc. 3N FN-3724:Too Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-4647 Sex:Female Group: 1 3) FN-392430 ppe Fate: (Weekz105)Sacrificedin extromis MicroscopicObservations(continued): Heart Kidney Lung Mammary 61and Pancreas Pituitary -Pericarditisc,hronic,diffuse,moderate -Chronicprogressivenephropathylmoderate Pyelonephritisa,cute,unilateral,marked -Vascularmineralizationm,ild Metastaticneoplasm Pleuritis,chronic,diffuse,moderate -Not examined,missing -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Spleen,Liver,Uterus,Ovary,Stomach,UrinaryBladder,Thyroid,ParathyroidT,rackta, Esophagus,SalivaryGland. ------------------------------- - --------------------- Animal Number: IR-4949 Sex: Female Group: 3) FN-392430 ppa Fate: (Weeka 65) FoundDead MicroscopicObservations: liver Skin Kidney MicroscopicObservations: Adrenal Esophagus Liver Lung Mammary 61and Ovary Pancreas Parathyroid Pituitary Salivary61&nd Skin Thyroid Trachea UrinaryBladder -Subcutaneousmass, 2 1 1.5 ce, -Mottled -Not examined,missing -Not examined,missing -Portalbileductproliferationm,inimal -Vascularmineralizationm,ild -Adenocircinna -Not examined,missing -Not examined,missing -Not examined,missing -Adencoa -Not examined,missing -Subcutaneous&ass not availablefor microscopicexamination -Not examined,missing -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Spleen,Kidney,Heart,Uterus,Stomach,Brain. - -- ------------------------------ Species:Rat Project Number: 0281CROO12 Summarized STAR Pig#: 2 400 SummarizSeidnglTeabulatAendisaRleport(continued) IndividuMaalcroscopaincdNicrostopOibcservations RikerLaboratoriIensc,.3H FN-3924T:ooYearOralToxicity-WcogeniSctiutdyyinRats Table2: AnimaNlumberI:R-4849 Sex:FemaleGroup:3)FN-392340ppe Fits:(Nnkz105)TerminaSlacrifice NacroscapOibcservations: Pituitary MicroscopOibcservations: Adrenal Kidney Liver Lung Pancreas Pituitary Thyroid -Raisemdass,1.3cedia. -Sinusoidaacltasiac,ortexm,arked Corticadlegeneratiloonc,alareasm,oderate -Pyelitiasc,uteu,nilateramli,ld -Portamlanonuclecaerllinfiltratsei,ld Necrosifso,cal,mild -Vascule sintralizationB,ild Alveolareacrophages,oultifocal,sild -Not examined,missing -Adenm -C tell adenost The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Uterus,Ovary,Naimarygland,Stomach,UrinaryBladder,Parathyroid,Trachea, Esophigus,SalivaryBland. ----------- ------- AnisalNuabor:IR-4850 Sex: Female Group: 3) FN-392430 pps Fate: (Neekm 86) Sacrificedin extramis MacroscopicObservations: MammaryBland Spleen MicroscopicObservations: Adrenal Kidney Liver Lung Nam"ry Gland Ovary Parathyroid Pituitary Skin Spleen Thyroid -Firs mass,9 1 8 x 5 co, in left alilla, extendingup over back,* cysticmass, 3 ce dia, leftinguinalarea. -Slightlyenlarged -Sinusoidalectasia,cortex,sild -Chronicprogressivenophropithy,mild -Resitopoiesisv,itramedullarys,ild -Vascularmineralizations,ild Hemorrhage,local areas,moderate -Fibroadenosa -Tubularhyperplasia,itild -Not examined,missing -Not examined,missing -Fibrosarcosa -Nomatopoitsise,xtramedullaryi,ncreased, marked -Not examined,missing The followingtissueswere found to be within normallimits: Heart,Uterus,Stomach,UrinaryBladder,Trachea,Esophagus,SalivarySland,Pancreas,Brain, ---- -------------- Species:Rat ProjectNumber:031CROO12 SummarizedSTARPage: 210 401 Sumaritod SingleTabulatedAnimalReport(continued) IndividualRacroscopicand Nicroscapibcwvations RikerLaboratoriesI,nc. 3N FN-3q24:Two Year OralToxicity-OncogenicitSytudyin Rats - -- -- - - --- - -- - AnimalNumber: IR-4850 Six:Fasile 6roup: 3) FN-392430 ppe Fate:(kekz B6) Sacrificeidn extresis Table:2 NicroscapiOcbservationsfcmtinued): The followingtissueswerefoundto be withinnormallimits(continued): LymphNode (sesenteric). Animal Number: IR-4851 Sex: Fesile Broup: 3) FN-392430 ppe Fate: (Weeka104) Found Dead NacroscapicObservations: Liver Spleen Uterus Pituitary Stomach NieoaryBland NicroscopicObservations: Adrenal Kidney Liver Lung Nameary Bland Pituitary Skin SPIM Stomach Thyroid UrinaryBladder Uterus -Palt -Enlarged -hrk mass,2 1 0.7ca, in rightuterinehorn near cervix. -Enlargedwith a dark mass,0.2 ce dia. -Nultipl4eKi of erosions. -Nass,2 1 1.5ce, leftaxillaisultilobular mass,5.5 1 2 1 3.5 ce, right inguinalarea;cysticmass,6 x 2 1 4 to, perinealarea. -Cortical,-Y&cuolatiloonc,alareas,eoderate Siiiusoidaelctisia,cortex,marked Nesatopoitsise,xtraiiedullirmyo,derate -Pelvicaiwalization,sild Resitupoirsise,xtrasedullarym,oderate Nophrosis,tubular,moderate -Necrosis,centrilobularm,oderate Pmatopoitsis,titrandullarym,oderate -Vascularsineraliziitiomni,ld Pneumonia,acuteexudative,oultilocal,sild 4ibroadtnosi salictocile Adenocarcinosa Extensivenecrosisand inflammation. -Adenosa -Fibroma -Heo&tDpoiesiso,xtratedullaryi,ncreased, &irked -Necrosisf,ocal,sucosal,sild -HyperplasiaC,cell,focal,mild -Epitheliahlyperplasias,imple,di4fustosild -Nomangiola Largenm*lise with CavernousVAKUlar spaces,n*tensive thrombosisaM inflammation. Species:Rat Project Number: 0201CROO12 &,ms ized STAR Page: 211 402 SummarizedSingleTabulatedAnimalReport (continuedl IndividualMacroscopicand MicroscopiOcbservations RikerLaboratoriesI,nc. 3M FN-3924:Two Year OralToxicity-UncogenicitSytudyin Rats Table:2 Animal Number: IR-4851 Six: Female Group: 3) FN-392430 pps Fate: (Week=104) Found Dead MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits: Heart,Ovary,Parathyroid,Trachea,Esophagus,Salivarygland,Pancreas. --- ---- --------- ------ - -------- Animal Number: IR-4852 Sex:Feeale Group: 3) FN-392430 ppe Fate: (Weeks100) Found Dead MicroscopicObservations: RantaryBlind Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Nameary Gland Pancreas Parathyroid Pituitary Spleen -Largeoultilobula&rass,9 x 7 s 4.5ca in rightaxilla. -Slightlyenlarged -Sinuscidalectasia,cortex,moderate Hesatopoiesise,xtramedullarys,ild -Pelvicmineralizationm,ild Bmtopoitsis,extrandullarym,ild -HepatDcytveacuolitiono,ultifocals,ild Necrosis,centrilobulars,ild Hes,itopoitsiesx,tranedullarym,ild -Vascularmineralizations,ild -Fibroadertasa -Not examined,missing -Not examined,not in plantof section -Menoma -NesitopDiesise,xtrazedullaryi,ncreased, marked The followingtissueswere foundto be withinnormallimits: Heart,Uterus,Ovary,Stomach,UrinaryBladder,Thyroid,Trachea,Esophagus,SalivaryGland. ---------------------- --- - --- - Animal Number: IR-4853 Sex: Female Group: 3) FN-392430 pps Fate:(Weeks 88)Sacrificedin extresis MacroscopicObservations: Pituitary MicroscopicObservations: -Raisedhemorrhagicmass,I 1 0.5 ca. Adrenal Liver -Sinusoidaelctasia,cortex,mild -* atocytevacuolitionp,eriportalm,ild Lung -Vascularmineralizations,ild Perivasculaarmonuclearinfiltratem,ild Hemorrhage,oultifocal,mild - ---- - ----------- -- - ------------ Species:Rat Project Number: 02BICROO12 Susimized STAR Page: 212 403 SummarizSeidnglTeabulateAdnimaRleport(continued) IndividuRaalcroscapaincdNicroscopOibcwvations RikeLraboratorIinecs.,3N FN-3924T:ooYearOralToxicity-OncogenSitcuidtyiynRats ---------------AnimalNumber:IR-48M Six:FemaleGroup: 3) FN-392430 ppe Fate:(Meek=88)Sacrificeidn extresis Table2: NicroscapOibcservation(scontinued): Ovary Pancreas Pituitary Spleen -Notexaminedm,issing -Notexaminedm,issing -Adenami -H"osiderosism,oderate Thefollowintgissueswerefoundto be withinnormallimits: Kidney,Heart,Uterus,MammaryBland,StomachU,rinaryBladderT,hyroidP,arithyroiTdr,achei, EsophagusS,alivarGyland. ------------------------------------ AnimalNumber:IR-4854 Sex:FemaleGroup: 3) W3924 30 pps Fate:(Week=105)TerminaSlacrifice RacroscopiOcbservations: Pituitary HassiryGland HicroscapiOcbservations: Adrenal Kidney Liver Lung RamearyBland Ovary Pancreas Parathyroid Pituitary Thyroid -Hemorrhag&iacss,I ce dia. -Cysticlobulasrits,6 x 5 x 3 co,left inguinaalrea. -Sinuscideacltasiac,ortex,@irked Corticadlegeneratioonu,ltifocalm,ild -Chronipcrogressivne phropathmyi,ld Pelvicmineralizatiosni,ld -Portalsononaclecaerllinfiltratem,inimal Portalbileductproliferatiomni,nimal -Yasculamrineralizatiomni,ld Perivisculwanronuclearinfiltratem,inimal 4ibroadonna -Tubulahryperplasibai,lateralm,arked -Isletcelladenosa -Notexaminedm,issing -Adencei -Notexaminedm,issing Thefollowintgissueswerefoundto be withinnormallimits: Spleen,Uterus,StomachU,rinaryBladderT,racheaE,sophagusS,alivarGyland,Heart. ---- ------- ---------- -------------- SpeciesR:at ProjecNtumber0:281CROO12 SummarizSeTdARPage:213 404 SummarizedSingleTabulatedAnisalReport lcontinued) IndividualMacroscopicand MicroscopicObservations RikorLaboratoriesI,nc. 3K FN-3924:Two YearOral Toticity-OncognicitSytudyis Rats Table:2 AnisilNumber:IR-4BZ Sa: Fisail SW Fate: tneekz105)TerminalSacrifice 3) FN-392430 ppe MacroscopicObservations: Pituitary Naa"ry Gland MicroscopicObservations: Adrenal Kidney Liver Lung Massary Bland Ovary Pancreas Pitu4.tary -Raised@ass,0.5 ce dia. -Mass,5 x 3 es, rightaxilla;fire&ass,11 x 6 x 3 ce,rightinguinilarea. -Sinusoidaelctasia,cortex$"rked Cwtical degeneration,moderate -Chronicprogressivenephrdpathy,sild Pelvicmineralizatiosni,ld -Portalsonanucleacrellinfiltrates,ild Portalbileductproliferationm,ild Kmtopoiesir,,extramedullarym,inimal -Alveolarmacrophageso,ultifocal,sild Brinuloaa,fkal, Minimal 4ibroadenota Adenocarcinus AdtAKircino" appearsto &risefroma fibroadeno". -Tubularhyperplasiab,ilateral,mild -Acinaratrophy,mild -Adeno" The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Uterus,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea,Esophagus, SalivaryBland,LyaphNode (sesenteric). -------------------------------------------------------------------------------------------- Anisal Number: IR-4856 Sex: Female Group: 3) FN-3924 30 ppe Fate:tkeeks91) Sacrificeidn extresis MacroscopicObservations: Pituitary -Largehesorrhagicmass,I x 1.5 ca. MicroscopicObservations: Adrenal Kidney Liver -Sinusoidaelctasia,cortex,sinizal -Chronicprogressivenephropathy,minimal -Portalmononucleacrell infiltratem,inimal Hepatocytevacuolitionp,eripartal,mild Lung Pituitary SalivaryGland stomach -Hemorrhageo,ultifocalm,ild -Adenoma -Not examined,missing -Edema, subsucosal,moderate 6r&nulosa,minimal Uterus -Polyp --- ----------------------------------------------------------- Species:Rat Project Number: 0261CROO12 Summarized STAR Page: 214 45 SummarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3h FN-3924:Two Year OralToxicity-OncogenicitSytudyin Rats -- --- ------ - ----------AnimalNumber: IR-4056 Box: Female Group: Fate:(Week= 91) Sacrificeidn extresis 3) FN-392430 ppe Table:2 MicroscopicObservationslcantinued): The followingtissueswere foundto be withinnormallimits: Spleen,Heart, Ovary,Mammary Gland,UrinaryBladder,Thyroid,ParathyroidlTrachea,Esophagus, Pincreis,Brain,LymphMade (mesenteric). ------------- Animal Number: IR-4857 Sri: Female Group: 3) FIF392430 ppe Fate:(Week= 60) Sacrificeidn extresis MacroscopicObservations: Liver Spleen Uterus MicroscopicObservations: Adrenal Kidney Liver Lung Haseary Bland Parithyroid SalivaryBlind Spleen UriniryBladder Uterus -Palo -Enlarged -Prolapsedthroughcervix. -Corticalvaevolitionm,inimal -Chronicprogressivenephropathy,minimal -Hnatopciesis,extrisedullarym,inimal -Yascularmineralizationm,inimal Hemorrhage,local areas,mild @NOt OKIliftedlmissing -Not examined,not in plantof section -Not examined,missing -Himatopoiesite,xtramedullaryi,ncreased, marked -Not examined,missing -Inflammation,acute, marked Inflammationlimitedto prolipsedportionof uterus. Not consideread setritis. The followingtissueswere foundto be withinnormallimits: Heart,Ovary,Stomach,Thyroid,Trachei,Esophagus,Pituitary,Pancreas,LargeIntestine, LymphNode (sesentericl. --------- --------------- ----------------------- -------- ------------ ----------- An4analNumber: IR-4858 Sex: Female Broup: 3) Fli-392430 pps Fite: (Weekz105)TerminalSacrifice MacroscopicObservations: Pituitary MicroscopicObservations: Kidney Liver -Hemorrhagic&ass,0.5 ce dia. -Pelvicmineralizationm,ild -Wepitacytveicuolitiono,ultifocals,ild Hemitapoiesise,xtriswullarys,igisal Species:Rit Project Number: OnICROO12 Summarized STAR Page: 215 406 Sumarized SingleTabulatedAnimalReporticontinued), IndividualNacroscapiacnd MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924T:woYearOralToxicity-OneogeniciStyudyin Rats Table:2 Animal Number: IR-4058 Box:Female Group: 1 3) FN-392430 ppe Fate: lneeka105)TerminalSacrifice MicroscopicObservationstcontinued): Lung Pancreas Pituitary -Yasculasrinerilizatiosni,ld -kinar atrophy,sild -Aden=& The followingtissueswerefoundto be withinnormallimits: Sploen,Heart,Uterus,Ovary,Mammary61&nd,Stomach,UrinaryBladder,Adrenal,Thyroid, Pirathyraid,Trachea,Esophagus,SalivaryBland. ------------------------- - - --------------- AnizalNumber: IR-4859 SIX: Female Group: 1 3) FN-392430 ppe Fate: (Week=105) TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Heart Kidney Liver Lung SalivaryGland Uterus -No visiblelesions. -Sinusaidalectasia,cortex,marked -Myocardiaflibrosis,oultifocalm,ild Myocarditis,chronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropithy,marked -Portalsononucleacrellinfiltrates,ild Portalbileductproliferationm,ild kpatkytt Y&CUOI&tiORi,tultifocasli,ld -Yasrularmineralizatiosni,ld Alveolarmacrophageso,ultifkal,mild -Siiladeniticsh,ronic,sild -Cysticglands,moderate The followingtissueswere foundto be withinnormallimits: Spleen,Ovary,MammaryGland,Stomach,UrinaryBladder,Thyroid,Parathyraid,Trachea, Esophagus,Pituitary,Pancreas. -------------------- --- ------ --- ---- -- -------------- -- ----------- ----- ---------- Anisal Number: IR-4860 Sex: Female Group: 3) FII-392340 ppe Fate:(Weekz72) Sacrificeidn extremis MacroscopicObservations: Skin MicroscopicObservations: Kidney Liver ------------- -- - --- ------ --- ------- -Circumscribeudlceratedmass,0.4 ce dia., left bind4oct;largesubcutaneous &as&,3 x 10 s 11 ce, right inguinalarea. -Chronicprogressivenephropithy,minimal -Hnatopoiesis,extramedullarym,inimal Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 216 407 SummarizedSingleTabulatedAnimalReport (continued) .1adividul Macroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too YearOral Toxicity-OncogeniciSttyudyin Rats - -- -- -- -- -- ---Anisal Number:IR-4860 Box: Fusle Group:1 3) FN-392430 ppe Fate:(Metka72) Sacrificeidn extruis Table:2 MicroscopicObservations(continued): Lung Naamary Gland Ovary Pirathyroid Sk'in Spleen Thyroid -Vascularmineralizationm,inimal Hyperplasias,eptalcell,focal,mild -Not examined,missing -Cyst,unilateral -Not examined,missing -Pododersatitiusl,cerativeu,nilateral, marked Fibroma Largelesionfrom inguinalarea. Extensive necrosis. -Hematopoitsise,xtrasedullaryi,ncreased, moderate -Not examined,missing The followingtissueswerefoundto be withinnormallimits: Heart,Uterus,Stomach,UrinaryBladder,Adrenal,Trachea,Esophagus,SalivaryGland, Pituitary, Pancreas. Animal Number: IR-4861 Sex: Female Group: 31'FN-392430 ppe Fate: (Weiik1z05)TerminalSacrifice MicroscopicObservitions: Lymphkode (sesenteric) MicroscopicObservations: Adrenal Kidney Liver Lung Lymph Mode (sesenteric) Uterus -Enlarged -Corticalvacuolitionl,ocalareas,moderate linusoidalectasiiic,ortex,moderate -Chronicprogressivenephropithy,minimal -Portalsononucleacrellinfiltratem,ild HepitKytovacuolations,ultilocals,ild -Vascularmineralizationm,ild -Sinusoidalectasia,moderate -Cysticglands,moderate Thefollowingtissueswe foundto be withinnormallimits: Spleen,Heart,Ovary,Hamry Bland,Stomach,UrinaryBladder,Thyroid,Parathyraid,Trachea, Esophagus,SalivaryGland,Pituitary,Pancreas. Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 217 408 SummarizedSingleTabulatedAnimalReport leontinued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N. FN-3924:Two Year OralToxicity-OncogenicitSytudyin Rats Table:2 Animal Number: IR-4862 Six: Female Group: 3) FN-392430 pps Fate:lkekz 93) Sacrificeidn extresis MicroscopicObservations: Pituitary Stomach Liver MicroscopicObservations: Adrenal Heart Kidney Liver Lung Pancreas Pituitary Skin Spleen Stomach Urinarygladder -Mass,I I O.B Co. -Enlargedgastricrugat. -Paleand sattled. -Sinusaidalectasia,cortex,moderate -NyDcarditisc,hronicnonsuppurative, oulti4ocal,minimal -Chronicprogressivneephropithy,sild Pelvicmineralizationm,inimal -Portalmmonucltarcellinfiltratem,ild Portalbileductproliferatiosni,ld *atocyte vacoolationd,iffuse,marked Necrosis,4ocal,minimal -Yascularmineralizations,ild Perivasculasrononucleairnfiltratem,ild -Not examined,missing -Adenosa -Liposa -Hemosiderosis,mild -Bastritisa,cute,moderate Edema, subsucosal,moderate -Epitheliahlyperplisias,imple,diffuse,sild The 4olloNingtissueswere foundto be Nithinnormallimits: Uterus,Ovary,MammaryGland,Thyroid,Parathyraid,Trachea,Esophagus,SalivaryGland. ------------------------------------------------- Anisal Number: IR-4063 Six:Feeale Group: 3) Ffl-392340 ppe Fite: (Weeks105)TerminalSacrifice MicroscopicObservations: Pituitary Maneiry Gland -Mass,0.3 co dia. -Mass,1.5x I ca, perintalarea!cysticmass, 2.51 1.5x I ca,leftixilla. MicroscopicObservations: Adrenal Kidney Liver Lung Mammary Gland -Sinusaidalectisia,cortex,minimal -Chronicprogressivenephropathy,mild -Hapatocytveicualationo,ultifocalm,ild -Mineralizationf,ocal,parenchymalm,ild -Adenociircinosa Lobularhyperplasia Ovary -Cyst,unilateral -------------- - - --- - ---------------------------- Species:Rat ProjectNumber:0261CM12 SummarizedSTAR Page: 216" 409 Sumarized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats ---------- -- ---------- Animal Number: IR-4863 Sex:Fosale Broup: 3) FN-392430 ppe Fate: (Neekz105)TerminalSacrifice Table:2 MicroscopiOcbservations(continued): Pituitary -Adenm The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Uterus,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea,Esophagus, I SalivaryBlind,Pancreas. ------------------------------------------ - --- --------- - -------- Animal Number: IR-4864 Sex: Female Group: 3) FN-392430 ppe Fate: (Week=105)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Kidney Liver Lung -k visiblelesions. -Sinusaidalectasia,cortex,moderate -Chronicprogressivenophropathy.m,inimal -Portalsononucleacrellinfiltratem,ild Portalbileductproliferatiosni,ld Hopatocytoalteration,vacuolated,fK&I, mild -Yascularsineralizationm,ild The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Uterus,Ovary,Mammary61and,Stomach,UrinaryBladder,Thyroid,Parathyraid, Trathei,Esophagus,SalivaryGland,Pituitary,Pancreas. -- ----------------------------- - -- ---------- --- ----------------- Animal Number: IR-4865 Sex: Feeale Broup: 3) FN-392430 ppe Fate: (Week-105)TerminalSacrifice MacroscopicObservations: Pituitary Mammary Bland Adrenal MicroscopicObservations: Adrenal Esophagus Heart Kidney Lung -Raisedlesion,0.5 co dia. -Kass,3 x 2 1 2 ce, perinealarea. -Leftenlarged,massI s 0.6 to. -Sinusoidaelctasia,cortex,marked Nodularhyperplasia,cortex,moderate Corticaldegeneration,localareas,moderate -Not examined,missing -NYK&rditis,chronicnonsuppurative, BUItifK&I,mild -Chronitprogressivenephropathys,ild Pelvicoiwalization,sild -Yascularsintralizatiomni,ld Alveolaraacrophagesf,K&I, Bild Puivascularsmonucler in4iltratisgild Species:Rat Project Number: 0281CROO12 Smoarized STAR Page: 219 410 Suurized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 AnimalNumber: IR-4865 Sex:Foile Group: 3) FN-392430 ppe Fate:(Week=105)TerminalSacrifice MicroscopiOcbservation(scontinued): Mammary Bland Ovary Parithyroid Pituitary Spleen Thyroid Trachea -Fibroadenosa 611actacell -Cyst,unilateral Tubularhyperplasiau,nilateralm,oderate -Notexamined,missing -Adenosa -Hisosiderosissi,ld -Not examined,missing -Not examined,missing Thefollowingtissueswerefoundto be withinnormallimits: Liver,Uterus,Stomach,UrinaryBladder,SalivaryGland,Pancreas. ---------------------------------------------- AnimalNumber: IR-4866 Six: Female Group: 3) FN-392430 pps Fite:(Weekz11)Sacrificeidn extremis MacroscopicObservations: Pituitary ThylBift Kidney Adrenal gasury Blind -Enlargeddueto hemorrhagicmass,I ce dia. -Appearsenlarged -Possiblyenlarged -Leftadrenalenlarged. -Ulcerateodultilobulamrass,3 x 2.5 x 2 cm, in rightaxilla. MicroscopicObservations: Adrenal -Corticavlacualationl,ocalareas,unilateral, moderate Sinusoidaelctasia,cortex,unilateral, moderate Corticaldegenerationl,ocalareas, unilateralm,oderate Heart -Myocarditisc,hronicnonsuppurative, oultifocalm,ild Kidney -Chronicprogressivenephropathy,moderate Pelvicsineralizatiomni,nimal Liver Lung -Portalsononucleacrellinfiltrates,ild -Vasculasrintralizatiosni,ld Hemorrhage,diffuse,marked Mammary Gland Parathyroid -Adenocarcinoma -Notexamined,not in planeof section Pituitary -Adenoma SalivaryGland -Not exaeined,missing - ------------------------- -- -- Species:Rat Project Number: 0261CROO12 SunariztdSTAR Page:220 41 1 Suourized SingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RiierLaboratoriesI,nc. 3N W3924; Too Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 Animal Number: IR-4666* Sex: Female Group: 3) W3924 30 ppe Fate: (Weeks 91) Sacrificedin extreais MicroscopicObservations(continued): Thymus -Lyaphosarcoma The followingtissueswere foundto be withinnormal limits: Spleen, Uterus, Ovary, Stomach,Urinary Bladder,Thyroid,Trachea, Esophagus,Pancreas, Lymph Made (sesenteric). ---- ------------------------- Animil Nuabor: IR-4867 Sex: Fatale Group: 3) FN-3924 30 ppe Fite: (Week= 87) Sacrificedin extresis Microscopic Observations: Pituitary Mammary Gliind Adrenal Microscopic Observations: Adrenal Kidney Lung Pituitary:@'"" Spleen Stomach Uterus -Nnarrhagic mass, 1.3 1 1 ca. -Milkcystsin perintalarea. -Left adrenalenlargedwith dark raised lesion,0.2 ca dia. -Sinvioidalactasia,cortex,marked -Chronic progressivenephropathy,minimal Pyelitis,acute,unilateral,minimal -Vascularsintrilizationm,ild Alveolar eacrophages,mild Perivascularsononuclearinfiltrate,mild -Adenosa -Hemosiderosis,moderate -Ulcer -Cystic glands,moderate The followingtissueswere found to be within normallimits: Liver,Heart, Ovary,Rieury gland,UrinaryBladder,Thyroid,Parathyroid,Trachea,Esophagus, Salivary 61,ind,Pancreas. ----------------------- - ---- Animal Number: IR-4868 Sex: Female Group: 3) FN-3924 30 ppe Fate: (Week= 96) Sacrificedin extresis Macroscopic Observations: Pituitary -Raised hemorrhagicmass, 0.9 ce dia. Microscopic Observations: Adrenal Kidney Liver Lung -Sinutoidalectasia,cortex,moderate -Chronic progressivenephropathy,ainisal -Htp&tKYte vicualation,oultifocal,minimal -Vascularsinerilizationsjild Alveolarascrophagesl@UltifK&ll Dild Perivascularsofianucleairn4iltrati,sild koorrhage, localareas,moderate - ------------------- ----------- - ------ Species: Rat Project Number: 02BICROO12 Summarized STAR Page: 221 412 SmarizedSinglTeabulatAendimaRleportleontinued) IndividuNaalcrostopaincdMicroscopOibcservations RikeLraboratorIinecs.l3K FM-3924T:ooYearOraltoxicity-WcolonicSituydyin Rats Table: 2 Animal Number: IR-4668 Sex: Female Group: 3) FN-3924 30 ppe Fate: IV"kz 96) Sacrificedin extresis MicroscopicObservations(continued): Ovary Pituitary Spleen -Tubularhyperplasialunilateral,mild -Adenuot -Nesusiderasis,moderate The folloving.tissuewsere found to be within normallimits: Heart, Uterus,Mammary Gland, Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea, Esophagus, Salivary Gland, Pancreas. ------------------------ - --- - - ---- -- ---- - --- --- - --- -- --- ----Animal Number: IR-4869 Sex: Female Group: 3) FN-3924 30 ppe Fate: (Netk-1-05) TerminalSacrifice MicroscopicObservations: Mammary Gland Microscopic Observations: Adrenal Kidney Liver Lung Hassiry Gland Pancreas Parathyroid Pituitary Spleen Uterus -Hass,9 x 6 1 4 cm, perinealarea. -Sinusaidalectasia,cortex,mild Medullarytell hyperplasiaf,kal, Mild -Hyperplasiap,elvic epithelium,unilateral, sild -Repatacytevacuolation,oultifkal, minimal Nepatocytealteration,basophilic,focal, minimal -Yascularmineralizations,ild Alveolareacrophages,@UltifK&l, mild -Adenocarcincea -Not examined,missing -Not examined,not in plant of section -Adencoa -Hematopciesis,extramedullary,increased, mild -Polyp The followingtissueswere found to be withinnormallimits: Heart, Ovary, Stoaich,UrinaryBladder,Thyroid,Trachea,Esophagus,SalivarySland. ---------t--------- - - --------------------------- Anisal Nuabor: IR-4870 Set: Fesale Group: 3) FN-3q24 30 ppe Fate: (Wookm105) TerminalSacrifice Macroscopic Observations: Pituitary MicroscopicObservations: Adrenal -Smalldarkraisedlesion,0.3 ce dia. -Sinusaidalectasia,cortex,moderate Species:Rat ProjectNumber:0281CROO12 SummarizedSTAR Page:222 413 SummarizedSinglTeabulatAendimaRlepor(tcontinued) IndividuMaalcroscopaincdMicroscopOibwc vitions RikerLaboratoriesI,nc. 3N FN-3924:Two YearOralTozirity-OntagenicitSytudyin Rats ---- --- ---Animal Number: IR-4870 Sex: Female 6roup: Fate: (Neekz105)TerminalSacrifice 3) Frr3q2430 pps Table:2 MicroscopicObservations(continued): Heart Kidney Liver Lung Pituitary Thyroid -Endocarditisc,hronic,focal,mild -Chronic.progressivneephropathy,minimal Pelvicmineralizationm,oderate -Hipatocytovacuolationp,eripartil,moderate -Vascularmineralizationm,inimal -Adeposi -Notexamined,not in plantof section The followingtissueswere foundto be withinnormallimits: Spleen,Uterus,Ovary,NasiiarByland, Stomach,UrinaryBladder,Parathyroid,Trachea,Esophagus, SalivaryGland,Pancreas. ------------------------------- -- ---- -------------- species:Rat ProjectNumber:OnICRO12 Summarized STAR Page: 223 414 gwmrized SingleTabulatedAnimalReport Individul Microscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral 7oxicity-.DncogniciSttyudyin Rats Table: 2 Animal Number: IR-3811 So%: Kale Group: 1 4) FN-392410 pps Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Microscopic Observations: Heart Ki"d6ey Liver Lung -No visiblelesions. -Myocarditis,chronicnonsuppurative, UltifK&I, mild -Chronic progressivenephropathy,mild -Portalsonanuclearcall infiltrate,mild Portalbileduct proliferations,ild Cystoid degeneration,4ocal, mild -Yascularmineralizations,ild The followingtissueswere found to be withinnormallimits: Spleen, Testis/EpididysisP,rostate,Stomach,UrinaryBladder,AdrenallThyroidgParathyroid, Trachea,Esophagus,SalivaryGland, Pituitary,Pancreas. ----------- Anisal Nueber: IR-3812 Sex: Mile Group: Fite: (Week= 87) Sacrificedin extresis 4) FK-3924 10 pps MacroscopicObservations: Pituitary Microscopic Observations: Adrenal Kidney Liver Lung Pituitary Prostate Spleen -Largehemorrhagic&ass, 1.2 x Ica dia. -Sinuscidailctisia,cvtox, diffuse,sild -Chronic progressivenephropithy,mild Pelvicmineralizations,ild -Portalbile duct proliferationm,ild Portalsononucleacrell infiltrate,mild -Yascularmineralizationb,ild Hemorrhage,local areas, moderate -Adenola -Prostatitis,acute,@eked -Nesosiderosis,moderate The followingtissueswere found to be withinnormal limits: Heart, Testis/EpididyeisS,tomach,UrinaryBladder,Thyroid,Parathyroid,Trachea,Esophagus, SalivaryBland, Pancreas. ------- --- --------------------------- ---------------------- ------- -- - -- ------ ------- Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 224 415 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year OralToxicity-OncogeniciSttyudy in Rats Table:2 Animal Number: IR-3813 Sex: Nale Group: 4) FO-3924to ppe Fate: (Neeka106)Teraina)Sacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Esophagus Heart Kidney Liver Lung Pancreas Parathyroid Pituitary Salivarygland Thyroid Trachea -No visiblelesions. -Corticalvacualitionf,ocal,mild -Not examined,missing -Myocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropathy,sild -Portalsononucleacrell infiltratem,ild Ntg&IKYtOSiS, Minimal Necrosis,oultifocalm,ild -Vasculasrineralizitiosni,ld Alveolarmacrophagess,ultifocal,mild -Not examined,aissing -Not examined,missing -Adencei -Not examined,missing -Not examined,missing -Not examined,missing The follo*ingtissuesserefoundto be mithinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,UrifiarByladder. ---------------------------------------- --- - -- AnisalNuaber:IR-3814 Sex: Male Sroup: 4) FN-3924 10 ppe Fate: (Weekz106)TerminalSacrifice ---------------------------- MacroscopicObservations: Skin Adrenal MicroscopicObservations: Adrenal Heart Kidney Liver Lung Parithyraid Skin -------------- -- -- -Circularaisedin4la"atorylesion,le4t hind 4ootpad. -Rightadrenalslightlyenlarged. -PheochrDiiocytosbae,nign,unilateral -Myocarditisc,hronicnonsuppurative, oulti4ocals,ild -Chronicprogressivneephropithyo,ild -Portalmanonucleacrell infiltratem,ild Portalbileductproliferationm,ild Regalocytosism,ild -Vascularsintralizationm,ild Perivasculasronoftucleianrfiltrates,ild -Not examined,not in planeof section -Pododereatitiusl,cerativeu,nilateral, marked Species:Rat Project Number: 0281CROO12 Suescized STAR Page: 225 416 SummarizedSingleTabulatedAniul Report (continued) IndividualMicroscopicand HicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year OralToxicity-DncogenicitSytudyin Rats Table:2 Animal&Number: IR-3814 Sex: Halt Group: 4) Ffl-392410 ppe Fate: (Reeks106)TerminalSacrifice MicroscopicObservations(continued): 6rachea -Tracheitisc,hronic,mild The followingtissueswere foundto be withinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Thyroid,Esophagus, SalivarySland,Pituitary,Pancreas. --- ----------------------- --------- AniiialNumber: IR-3815 Sex: Male Group: 41 FN-3924 10 ppe Fate: (Reek-105)Sacrificedin extromis MacroscopicObservations: Abdomen(internal) Esophagus Spleen Liver Prost,ate Testis/Epididysis stomach MicroscopicObservations: Kidney Liver Lung Pituitary Prostate Testis/Epididysis Uriairylladder -Filledwithred fluid. -Enlargedwiththickenedualls. -Appears small -NediAnand left laterall&obesappearshrunken with veryroughsurface;left lateraland cauditelobespale with a oultilobulamrass,3.5 1 2.5 1 2.5 ca. -Appears seal1-. -Bothtestessmall. -Multiplefocalareasof ulceration. -Chronicprogressivenephropathy,sild -Portalsononucleacrell infiltratem,oderate Nepatocellularcarcinoma Atrophy,marked Fibrosis,pvtal, marked -Vascularmineralizations,ild Alveolarmacrophages,mild metistaticneoplasm -Cyst,parsintersedia -Prostatitisa,cute,marked -Tubuleatrophy,isperutogenesisb,ilateral, moderate -Epitheliahlyperplasias,imple,diffuse,sild The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Stomach,Adrenal,Thyroid,Parithyroid,Trachoa,Esophagus,SalivaryGland, Pancreas. species:Rit ProjectNumber:02BICM12 Summarized STAR Pig#: 226 417 Sumarized SingleTabulatedAnimalReport(continued)individualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-OncogenicitSytudyin Rats ----- ---------- ---Anisal Number: IR-3816 SIX: Nale Group: t 4) FN-392410 ppe Fate: (Neekz106)TerminalSacrifice Table:2 MicroscopicObservations: MicroscopicObservations: Adrenal Heart Kidney Liver Lung Testis/Epididysis -No visiblelesions. -Nodularhyperplasiac,ortex,focal,sild -Nyocardititc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenophropathy,sild -Portalsononucleacrellinfiltratea,ild NtQalKytDSit,minimal -Vascularsineralizatiosni,ld AlveolarKrophagts,@UltifKAI, mild Perivasculamronon@clearinfiltrate,mild Hemorrhage,local areas,moderate -Nesothelmi , benign Noll differentiatedp,apillaryneoplasm arisingfrom capsulesof both testes. The followingtissueswerefoundto be withinnormallimits: Spleen,Prostate,Stomach,UrinaryBladder,Thyroid,Parathyraid,Trachea,Esophagus, SalivaryBland,Pituitary,Pancreas. ---------- ------ -- ----------------------- --- - - -- --------- -------- Anisal Number:IR-3817 Sex: Male Broup: 4) FN-392410 pps Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Mammary Gland Microscopic Observations: Liver Lung Parathyroid Pituitary Skin -Large,firm,subcutaneoumsiss,9 x 6 x 5 ca, in leftinguinalarea -negalacytosism,inimal -Vascularsintralizatiomni,ld Pneumonia,interstitial,chronic, oulti4ocal, mild Alveolarsicrophiges,oulti4Kal, sild -Not examined,not in plant of section -Adenosi -Fibroma The followingtissueswe found to be within normal limits: Spleen,lidney, Heart, TestistEpididysis,Prostite,Stomach, Urinary Bladder, Adrenal, Thyroid, Trachei, Esophagut, Salivary Gland, Pancreas. ------------------------ - ----- -- ------ Species: Rat Project Number: 0281CROO12 Suawized STAR Page: 227 4 18 SomarizeSdinglTeabulatAendimaRlepor(tcontinutd) IndividualMacroscopicand MicroscopiOcbservations RikerLaboratoriesI,nc. 3N FN-3924:Too Year Oral Toxicity-OncogeniciSttyudyin Rats Tablt:2 AnimalNumber:IR-3818 Sex: Kale Sroup: 4) FN-392410 ppe Fate: (Weeks 76) FoundDead MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Lung Pituitary -Largehemorrhagimcass, 1.3 x 0.4 ca. -Withinnormalliaits One of pairpresent -Chronicprogressivneophropathys,ild -Vasculasrineralizatims,ild -Adinama The followintgissueswerefoundto be withinnormallimits: Spleen,Liver,Heart,Testis/EpididysiPsr,ostateS,tomach,UrinaryBladder,Thyroid, ParathyraidT,rachea,Esophagus,Salivarygland,Pancreas. ------------------------- --------------------------- --- ---- - AnisalNumber:IR-3819 Sex:Nale Broup: 4) FN-392410 ppe Fate: (Weeks106)TerminalSacrifice MicroscopicObservations: Skin MicroscopicObservations: Adrenal heart Kidney Liver Lung Pituitary SalivaryGland Skin Trachea -Raisedulceritedpinflasserdegionon right hind iootpad. -Corticavlacuolationo,ultifocalm,ild -Myocardiaflibrosiso,ulti4ociimli,ld -Chronicprogressivneephropaihym,ild -Negalocytosism,inimal -Vasculasrintralizatiosni,ld Alveolarucrophages,oultifocalm,ild Perivisculasrononucleairnfiltrates,ild -Adenota -Not examined,missing -Pododereatitiusl,cerativeu,nilateral, marked -Tricheiticsh,ronics,ild Thefollowintgissueswerefoundto be vi'L@innormal limits: Spleen,Testis/EpididysiPsr,ostate,St5sich,UrinaryBladder,Thyroid,ParathyraidE,sophagus, Pancreas. ---- -------- --------- --- --------------------------------------------- Species:Rat Project Number: 0281CROO12 Smvized STARPage:226@ 41-9 SumariiiiSdingleTabulatedAnjul Report(continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3q24:Two YearOral Toxicity-fhcoleniciSttyudyis Rats Table:2 Animal Number: IR-3820 Box: FAI i Group: t 4) FN-3924 10 ppe Fate: (Weeka106)TerminalSacrifice MacroscopicObservations: Pituitary Kidney MicroscopicObservations: Heart Kfdity Liver Lung Pancreas Parathyroid Pituitary Stomach Testis/Epididysis -Darklesion,0.41 0.2 ca. -blarged,paleandpitted. -Myocardiaflibrosis,localareas, moderate -Chronicprogressivenephropathy,marked -Portalemonucleiicrell infiltratem,ild Portalbileductproliferatiosni,ld Negalacytosism,inimal -Vascularsinwalization,mild Periv&Kularmonuclear infiltratem,ild -Polyarteritism,oderate -Not examined,not in plantof section -Adencea -Not examined,missing -Polyarteritism,oderate The followingtissueswere foundto be withinnormallimits: Spleen,Prostate,UrinaryBladder,Adrenal,Thyroid,TrachtliE,sophagusgSalivaryBlind. ----------------------------- Anita!Number: IR-3821 Sex:Halt Group: 4) FN-3924 10 ppe Fate: (Weekz85) Sacrificeidn extresis MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Lung Parathyraid Pituitary Spleen Stomach -Largemass,1.3 x I ca. -Withinnormallimits One of pairpresent -Chronicprogressivenaphropithypmoderate -Y&Kularsintralizatiomni,ld -Not examined,not in planeof section -Adennai -Onasiderasis,moderate -Ulcer,marked The followingtissueswere foundto be withinnormallimits: Liver,Heart,Testis/EpididysiPsr,ostate,UrinaryBladder,Thyroid,Trachea,Esophagus, SalivaryBland,Pancreas. - -------------------- - Species:Rat Project Number: 0261CRO12 Stmarized STAR Page: 229 420 SummarizedSingleTabulatedAnimal Report (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogenicitSytudy in Rats - ------------ ----- Animal Number: IR-3822 Box: Nale Fate: (Weekz106) TerminalSacrifice Group: 4) FN-3924 10 ppe Table: 2 MicroscopicObservations: MicroscopicObservations: Liver Lung Pituitary -No visiblelesions. -Portalsonanuclearcell infiltrate,mild Portalbile ductproliferationm,ild negalocytosis,minimal -Vascularaintralizations,ild -Adeno" The followingtissueswere found to be withinnormal limits: Spleen,Testis/EpididysisS,tomach,Urinary Bladder,Adrenal,Thyroid,Parathyraid,Trachea, Esophagus,SalivarySland, Pancreas,Kidney,Heart, Prostate. -------------------------------- --------- ------- - Anisal Number: IR-3623 Six: Nile Group: 4) FM-3924 10 ppe Fate: (Weekz 65) Sacrificedin extresis MacroscopicObservations: Pancreas Kidney MicroscopicObservations: Adrenal Kidney Liver Lung Thyroid -Smallnodule,0.5 1 0.7 ce, in areaof pancreas. -Rough surface -ginusoidaelctasialcortex,oultifocala,ild -Chronicprogressivenephropithy,sild -Portalsonanuclearcell infiltrate,minimal Portalbile duct proliferationm,inimal -Vascularmineralizationm,ild Hemorrhage,local areas,mild -Ultisobranchiaclyst The followingtissueswere found to be withinnormallimits: Spleen,Heart, Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Parithyroid,Trachea, Esophagus,Salivary Bland,Pituitary,Pancreas. -------------------------------- ----------------------------------- -- --- --- --------- Anisal Number: IR-3824 Six: Mile Fate: (Week=106) TerminalSacrifice Broup: 4) FN-3924 10 pps MacroscopicObservations: -No visiblelesions. Microscopic Observations: Adrenal -CorticalVICUDI&tiOn*,UltiiKAI, aild Kidney -Chronic progressivenophropithy,marked Liver -Portalmanonaclearcell infiltrate,minimal Portalbile ductproliferationm,inimal --- ------- --- --- ---------- ----------------------- --- -- -- --- Species: Rat Project Number: 0201CROO12 Sweirized STAR Page: 230 421 SummarizedSingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too Year OralToxicity-bcoginicitSytudyin Rats Table:2 Animal Number: IR-3024 Six: Kale Group: 4) FN-312410 ppe Fate: (Week=106) TerminalSacrifice MicroscopicObservations(continued): Lung Pancreas Parithyroid Pituitary 7estis/Epididysis -Vascularmineralizationm,ild Hemorrhage,local areas,moderate -Isletcell adenoma -Not examined,not in plantof section -Cyst,parsintersedii -Polyarteritism,inimal The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Prostate,Stomach,UrinaryBladder,Thyroid,Trachea,Esophagus,SalivaryGland. ------ --- -------- - ----------------- Animal Number: IR-3825 Sex: Halt Group: 4)FN-3924 10 ppe Fate: (Week=106) TerminalSacrifice MicroscopicObservations: Kidney MicroscopicObservations: Kidney Liver Lung Parathyroid Pituitary SalivarySland Trachea -Raisedpale*ass,0.4 ce dia.,in cortexof rightkidney. -Chronicprogressivenephropathy,sild Adenou Encapsulatedp,apillary-pattern. -Portalsononucleacrall infiltratem,ild Portalbileductproliferatioani,ld mogildcytosism,inimal -Vascularmineralizationm,ild Alveolareacrophageso,ultifocal,si'Ld -Not examined,not in plantof section -Adencea -Not examined,missing -Tracheitisc,hronic,sild The follouingtissueswerefoundto be withinnormallimits: Heart,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Esophagus, Pancreas,Spleen. --- ------ ----------------- ---- ------------------- --- - Animal Number: IR-3026 Six:Halt Group: 4) FN-3924 10 ppe Fate: (Weekz106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal -No visiblelesions. -Corticaldegenerationf,ocal,mild Species:Rat Project Number: 0201CROO12 Smariztd STAR Page: 231 422 Sumrized SingleTabulatedAnimalReport lcontinued)Individualkcroseopiacnd MicroscopiOcbservations RikerLaboratoriesI,nc. 3H FN-3q24:Two Year Oral Toxicity-OncogeniciSttyudyin Rats - ------------------Animal Number: IR-3626 Stx:Nale Group: 1 4) FN-392410 pps Fate: (Meek=106)TerminalSacrifice Table:2 MicroscopicObservationslcontinued): Heart Kidney Liver Lung Pituitary -Kyocarditisc,hronicnonsuppurative, sultifocalm,inimal -Chronicprogressivenophropathy,minimal -Kepatacytveacualationo,ultifocal,minimal Repitacytealterationv,acuclated, local areas,moderate Negalocytosiss,ild -Vascularsintralizatiomni,ld -Not examined,missing The followingtissueswere foundto be withinnormallimits: Spleen,Testis/EpididysiPsr,ostate,Stomach,Urinary)ladder,Thyroid,ParathyroidT,rachea, Esophagus,SalivaryBlind,Pancreas. --------------------------------- Animal Number: IR-3827 Sex: Male Group: 4) FN-3924 10 ppe Fate: (Week-106)TerminalSacrifice MacroscopicObservations: Skin MicroscopicObservations: Adrenal Heart Kidney Liver Lung SalivaryBlind Skin --Leir@ullf,-taiisnw4lastedlisiohs,'bothhind footpads. -Corticalvacuolationl,ocalareas,sild Pheochrosocytosa,benign -Myocardialfibrosis,localareas,moderate Endocirditisc,hronic,diffuse,eadlrate -Chronicprogressivenephropathy,sild -Portalsononucleacrellinfiltrates,ild Portalbileductproliferationm,ild Negilocytosism,inimal -Vascularsineralizitiomni,ld Pneumoniai,nterstitialc,hronic,oultifociil, sild Alveolarmacrophageso,ultifocal,mild -Not examined,missing -Podadereatitiusl,cerativeb,ilateralm,arked The followingtissueswerefoundto be withinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Thyroid,PirithyraidT,rachea, Esophagus,Pituitary,Pancreas. -- --- ---------- - - - ---- --------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 232 423 SummarizedSingleTabulatedAnimal ROPOrt lcontiftutd) IndividualMicroscopicand MicroscopicDbwvaticAs RikerLaboratoriesI,nc. 3M FN-3124:Two Year Oral Toxicity-OncogenicitSytudy in R&tS Animal Number: IR-3828 Sex: Nalii Group: Fate: lnetkz106)TerminalSacrifice ----- -- -- -- -4) FN-3924 10 ppe Table:2 MicroscopicObservations: Lymph Mode (sesenteric) MicroscopicObservations: Heart Kidney Liver Lung LymphNode (sesenteric) Pancreas Parathyroid -Softhemorrhagicmass, 1.5co dia. -Myocardiaflibrosiso,ultifocals,ild Nyocarditis,chronicnonsuppurative, sultifocals,ild -Chronicprogressivenephropathy,mild -Portalemonucltiiciarllinfiltratem,ild Portalbileductproliferationm,ild -Vascularaintralizationm,inimal Alveolareacrophigeso,ultifocalslild Perivisculasrononucleairnfiltratem,ild Hemorrhage,local areas, moderate -HosiLngiosarcosa -Acinaratrophy,sild -Notexamined,not in planeof section The followingtissueswere foundto be withinnormallimits: Spleen,Testis/EpididyeiPsr,ostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Trachei, Esophagus,SalivaryBlind,Pituitary. --------------------- -------------------------- - -- - - ----------- Animal Number: IR-3829 Sex: Nale Group: 4) FN-392410 ppe Fate: (Weekz106)TerminalSicrifice MacroscopicObservations: Pituitary Kidney -Hemorrhagicmass, 0.0 1 0.6 ca. -Hydronephrosisr,ightkidney. MicroscopicObservations: Adrenal -Sinuscidaelctasia,cortex,oultifkal,mild Medullarycell hyperplasia Corticaldegenerationf,ocal,mild -Kidney -Chronicprogressivenephropathys,ild Pelvicmineralizatiosni,ld Calculus,Pelvic Hydronephrosisu,nilateral Liver -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild Cystoiddegenerationo,ulti4ocal,mild Lung -Vascularsintralizatiomni,ld Porivasculasrononucleairnfiltratem,ild Pancreas -Acinaratrophy,vild Pituitary -Adencea - --------- -- ----------------- r*KiOS:Rat Project Number:OnICROO12 &marized STAR Page: 27.3 424 Sumarized SingleTabulatedAnimalReport(continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year OralToxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3829 Sex: Hale Group: 4) W3924 10 ppe Fate: (Meeks106) TerminalSacrifice MicroscopicObservationslcmtinued): Spleen Thyroid UrinaryBladder -Hemosiderosism,ild -C cell adenou -Papillosa The followingtissueswere foundto be withinnormallimits: Heart,Testis/EpididysisP,rostate,Stomach,Parathyraid,Trachea,Esophagus,SalivaryBland. ---------------- ------------ ------------- --- ------ ---------- ------ ------ ------- Animil Number: IR-3630 SeK: Mile Group: 1 4) FN-392410 pps Fate: (Weeks106)TerminalSacrifice MacroscopicObservations: Thyroid MicroscopicObservations: Kidney Liver Lung Prostate Testis/Epididysis Thyroid Trichea -Slightlyenlarged -Chronicprogressivenephropithy,minimal -Portalsononucleacrell infiltrates,ild Portalbileductproliferatiomni,ld NepatDcytaelterationv,icuolitedo,ultifocil, aild kgalocytosis,minimal -Yiksculamrineralizitionm,ild Alveolar"crophages,localareas,moderate -Prostatitisa,cute,moderate -Yasculisrineralizitimm,inimal -C cell adenoma -Tracheitisc,hronic,moderate The followingtissuesare foundto be withinnormallimits: Heart,Stomach,UrinaryBladder,Adrenal,ParathyroidE,sophagus,SalivaryGlandoPituitary, Pancreas,Spleen. - --- -------------- - -- ----------- Animal Number: IR-3831 Set:Mile Group: 4) FK-392410 ppe Fate: (Weeks101) Found Dead MicroscopicObservations: Skin Liver Kidney ----------- -Raisedulaceriteldesion,I to dia.,withscab formationl,eftside;firm subcutanewsmass,4 x 4 x 2.5 ce, right inguinalarea;ulceratedlesion,right hind footpad. -BeallPalo foci in several11615. -Palemass,0.5co dia.,in ptlvit,riigioofn rightkidney,anotherpile mass, species:Rat Project Number: 0281CROO12 SuioarizedSTAR Page: 234 425 SummarizedSingleTabulatedAnimalReport tcontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N W3924: Two Year OralToxicity-OncogeniciSttyudy in Rats Table:2 Animal Number: IR-3831 Six: Nale Group: 1 4) FK-392410 ppe Fite: (Neeks101)FoundDead MacroscopicObservations(continued): Kidney (continued) MicroscopicObservations: Adrenal Kidney Liver Lung Pancreas Skin Spleen Stomach -0.2cm dii.,in cortex. -Medullarcyellhyperplasiao,ultifocals,ild -Chronicprogressivenephropathy,mild Proteinresorptiondroplets,marked Malignantlyaphosa,histikytic -Malignantlymphoma,histiocytic -Vascularmineralizationm,ild Malignantlyaphota,histiocytic -Acinaratrophy,ainisal -Pododereatitiurl,c,erativeu,nilateral, marked Malignantlyaphota,histiocytic Multiplesubcutaneoutsuws. Ulcerated lesionfrom side consistsof dermal neoplasticinfiltratewithulceratedsurface. -fteatopoitsise,xtrasedullary,@--iftcreased, sild -Not examined,missing The followingtissueswere foundto be withinnormallimits: Heart,Testis/EpididyaisP,rostate,UrinaryBladder,Thyroid,ParathyroidT,rachea,Esophagus, SalivaryGland,Pituitary. --------------------------------------------- ---------------------------------------Animal Number: IR-3832 Sex:Nile Group: 4) FE-392410 ppe Fate:ineek-106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Kidney Liver Lung Thyroid -ka visiblelesions. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,ild Portalbileduct proliferatic,s@i.l,d Regalocytosism,inimal -Vascularmineralizationm,ild Alveolareacrophages,mild -C cell admosa The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Adrenal,Parathyroid, Trachea,Esophagus,SalivaryGland,Pituitary,Pancreas. --- ----------- ------------------- -- Species:Rat Project Number: 0281CRO12 Summarized STAR Page: 235 426 SummarizedSingleTabulatedAnimal Report (continued) IndividualMacroscopicand Microscopicobservations RikerLaboratoriesI,nc. 3N Fli-3924T:oo YearDral Toxicity-OncogeniciSttyudyin Rats ------ --------------- ------ - -- -- - -------------- AnimilNumber: IN-3833 Six:Halt Group: 4) FN-3924 10 ppe Fate: (Week-102)Sacrificedin extremis Tablt:2 MacroscopicObservations: Eye Pituitary Spleen MicroscopicObservations: Adrenal Eye Heart Kidney Liver Lung Pituitary Spleen Thyroid 4ocal cornealopacityin both eyes. -Darkmass,0.5 ce dia. -Slightlyenlarged -Corticalvacuolationl,ocalareas,mild Sinuscidaelctasia,cortex,diffuse,sild One of pair present -Keratitis, chronic, fK&I, bilateral, sild -Myocardiaflibrosiss,ultifocals,ild Nyocarditisc,hronicnonsuppurativt, BUItifKal,mild -Chronicprogressivenephropathy,aild -Nepatocytevacuolation,lUltifK&I, mild Mitoticactivityi,ncreasedd,iffust,sild -Yascularsinerilizitiomni,nimal -Adenoma -HmtDpoiesis, extramedullaryi,ncreased, moderate -Hyperplasifao,lliculacrell,diffuse,sild The followingtissuesotrefoundto be withinnormallimits: Testis/EpididyaisP,rostate,Stomach,Urinarylladder,ParithyroidT,richea,Esophagus, SalivaryGland,Pancreas. -------------------- --- --- -- -- --------- AnimalNumber: IR-U34 Sex: male Group: 1 4) FN-392410 ppe Fite:(Utekz70)Sicri4iceidn extrnis MicroscopicObservations: Liver Kidney MicroscopicObstrwations: Heart -Slightlypale -Slighthydronaphrosisl,eftkidney. -Myocarditisc,hronicnonsuppuritive, localareas,mild Kidney -Chronicprogressivenephropithy,minimal Hyperplasiap,elvicepitheliumo,ultifocal, Liver sild -Portalsononucleacrellinfiltrates,ild Portalbileductproliferationm,ild HOPItOCyteVaCUOlati0ft@,UltifK&lo mild Cystuiddegenerationf,ocal,sild N"alKYtOgiS, minimal --------------------- - ------------------------------- Species:Rat Project Number: 02BICROO12 Summarized STAR Page: 236 427 Sumarizod SingleTabulatedAnimalReport (continued)Individuaklerokopic andMicroscopiDcbwvations RikerLaboratoringInc. 3N FN-3924:Too Year OralToxicity-OncogenicitSytudyin Rats Table:2 Animil Number:IR-3834 Sex: Halt Group: 4) Fli-392410 ppe Fate:(leeks70) Sacrificeidn extresis Microscopic Observation(scontinued): Lung Pituitary SalivaryBland -Alveola"rcrophages,oultifocils,ild -Adennea -Not examined,missing The followingtissueswere foundto be withinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Parathyroid, Trachoa,Esophagus,Pancreas. --------- ---------------- ----------------------- --- AnitilNumber:IR-3835 Six:Mile Broup: 4) FN-3924 10 ppe Fite: (Meek=106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Heart Kidney Liver Lung Pituitary -No visiblelesions. -Myocardialfibrosis,localareas,moderate Myocardititc,hronicconsupparative, localareas,sild -Chronicprogressivenophropathy,minimal -Portalsononucleacrellinfiltratem,ild Nepatocytoalteritionv,acuoliteds,ultifocal, sild -YAKUI&R sineralizition, minimal Perivisculisrmonuclearinfiltrates,ild -Adenona The followingtissueswerefoundto be withinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Parithyroid, Trachea,Esophagus,SalivaryBland,Pancreas. --------------- - -- ------------------- Animal Number: IR-3036 Sex: Halt Group: 4) FN-392410 pps Fate: (Meekt106)TerminalSacrifice MicroscopicObservations: Eye Skin Stomach Kidney MicroscopicObservations: Adrenal -- --------- -Rightand lefteyes appearcloudy. -Raisedcircularmass,1.5 ce dia.,dorsal area. -Enlargedgastricrugae. -Severalraisedclearcysts,0.8 ce dia.,in leftkidney. -Corticalvicuolationfgocal,mild - ------- Species:Rat Project Number: 0261CROO12 kmrized STAR Page:237 428 Sumarized SinileTabulatedAnimalReport (continutd) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 AnisalNumber:IR-3836 Sex:Halt Group: 41 FN-3924 10 ppe Fate:(Week-106)TerminalSacrifice MicroscopiOcbservation(scontinued): Eye Heart Kidney Liver Lung Skin Thyroid -Cataractb,ilateral -Myocardiaflibrosiso,ultifocalm,ild -Chronicprogressivenephropathy,moderate Cyst,cortical -Portalsononucleacrellinfiltratem,ild -Vasculasrintralizatiomni,ld -Cyst,dermalinclusion -Folliculahryperplasicay,stic,unilateral, marked The followingtissueswerefoundto be withinnormallimits: Spleen,Testis/EpididysiPsr,ostate,Stomach,UrinaryBladder,ParathyroidT,riicheaE,sophagus, SalivaryBland,PituitaryP,ancreas. ------------------- ---------------------------- - --- --------- ------ AnimalNumber:IR-3637 Sex: Male Group: 4) FN-392410 ppe Fate:(Weeks106)TerminalSacrifice MicroscopicObservations: Eye MicroscopicObservations: Adrenal Eye Heart Kidney Liver Lung Pancrois Pituitary -Smallcorneallesion,righteye. -Corticavlacuclation4,ocal,mild Nodularhyperplasiac,ortex,swerite -Keratitisc,hronic,unilateralm,arked -Myocarditisc,hronicnonsuppuritive, oulti4ocals,ild -Chronicprogressivenephropathym,ild -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiomni,ld Hepatocytveacuolationa,ultifocalm,ild Hepatocytaelterationv,acuolatedo,ultifocal, mild Regalocytosism,inimal Fibrosis4,ocal,sild -VasculaBrineralizatiosni,ld Hemorrhageo,ultifocalm,ild -Hyperplasiaa,cinarcell,noditlarm,oderate -Adenosi The followintgissueswe foundto be withinnormallimits: SpleenoTestis/EpididysiPsr,ostate,Stomach,UrinaryBladder,Thyroid,ParithyroidT,rachea, Esophagus,SalivaryBland. ---------------- --- ------------------------------- Species:Rat ProjectNumber:02BICRO12 Sumarized STAR Page: 238 429 Sumriztd SingleTabulatedAnimalReport(continuw) IndividualMacroscopicand MicroscopicObwvitions RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3838 Sex: Halt Group: 4) FN-392410 ppe Fate:(Week= 93) Sacrificeidn extresis MicroscopicObservations: Soft Tissues(neck) MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Soft Tissues(neck) Testis/Epididysis -Firewhitemiss,2.5 x 2 ce in ventralneck area,possiblyarisingfrom body of cervicalvertebrae;mass beginningto involveesophagusand trachea, constrictintghee. -Pheochrosocytomab,enign,unilateral -Not examined,missing -Chronicprogressivenephropithy,minimal Pelvicmineralizationm,ild -Portalsononucleacrellinfiltrates,ild -Yascularsineralizations,ild Pneumonia,foreignbody, oulti4ocal,moderate 4ibrosarcosa Tumor does not appearto arise from bone. Smallareaof reactivecartilagewith mineralizationL.ocallyinfiltrative. .-Yasculamrineralizationg,ild-, The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Prostate,Stomach,Urinarylladder,Thyroid,ParathyroidT,rachea, SalivaryBland,Pituitary,Pancreas. ------ --- ----------------- ------ --- -------- -- --- --------------------------------- Animal Number: IR-3839 Sex: Nale Group: 4) FK-392410 ppe Fate: (Week=106)TerminalSacrifice MicroscopicObservations: Kidney MicroscopicObservations: Adrenal Heart Kidney Liver Lung Pituitary -Paleandpitted,slightlyenlarged;right hydronephrosis. -Sinusoidalactasia,cortex,focal,moderate -Myocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropithy,marked Hydronephrosisu,nilateral -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld negalocytosism,inimal -Perivasculaermonuclearinfiltratemlild -Hyperplasiaf,ocal,parsdistaliss,ild The followingtissueswere foundto be withinnormallimits: Spletn,Testis/EpididysiPsr,ostate,Stomach,Urinarylladder,Thyroid,ParathyroidT,rachea, -- --------- Species:Rat Project Number: 0261CROO12 Smariztd STAR Pap: 239 430 SummarizedSingleTabulatedAnimalReport ttontinved) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats -- - - ------------------- -- AnimalNusbtr:IR-3839 Six:Halt Group: Fate: (Weeks106)TerminalSacrifice 4) FN-3924 10 ppe Table:2 MicroscopicObservations(continued): The followingtissueswerefoundto be withinnormallimits(continued): Esophagus,Salivarygland,Pancreas. ------------------------------- --------- --------- ----- Animal Number:IR-WO Sex: Male Group: 1 41 FN-3924 10 pps .. Fate: (Weeks 57) Sacrificeidn extresis MacroscopicObservations: Lung Heart Liver MicroscopicObservations: Esophagus Heart Kidney Lung SoftTissues(thorax) -Largeyellowishgrey mass fillsentire throaciccavityand displacesnormal lungtissuedorsally.Hass measures4 x 4.5 x 2 ce,adheredto leftlateral thoracicitallr;ightapicallunglobe collapsed. -ftscleappearsflabby. -Palo -Not exabined,missing -Epicardit.isX,tw@anic.@,o@p,4,, mild -Mineralizatioanu,ltifocalc,orticall.mild -Yascularmineralizationm,ild Attlectasisd,iffuse,marked -Liposarcou The followingtissueswerefoundto be withinnormallimits: Spleen,Liver,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Adrenal,Thyroid, ParathyraidT,rachea,Salivarygland,Pituitary,Pantreas. ----------------- - -- - -- ------------ ------------------ --- Animal Number: IR-3841 Sex: Hale Group: 4) FN-3q2410 ppe Fate: (Week-1-06)TerminalSacrifice MicroscopicObservations: Skin MicroscopicObservations: Kidney Liver Skin Testis/Epididysis Trachea --- ------ -------- ---- -- -Raisedcircularlesionson both hind footpads. -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltratem,ild Portalbileductproliferationm,ild NeQ&IKYtOSiS, Minimal -Pododermatitisu,lcerative,bilateral,marked -Yascularmineralizations,ild -Tracheitisc,hronic,sild Specits:Rat Project Number: 0281CROO12 Summarized STAR Page: 240 431 SummarizedSingleTabulatedAnimalReport lcontinued) IndividualNacroscapicand NicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Animil Number:IR-3641 Six: Kale Group: 1 4) FN-392410 ppe Fate: (Weeks106)TerminalSacrifice MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Lung,Prostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Par&thyroid, Esophagus,SalivaryBlind,Pituitary,Pancreas. ------------- ------------------- AnimalNumber: IR-3042 Sex: Male Fite: (Week= 84) FoundDead Broup: 4) FN-392410 ppe NacroscapicObservations: Liver Small Intestine Large Intestine MicroscopicObservations: Adrenal Esophagus Liver Lung Pancreas Parathyroid Pituitary Prostate SalivaryGland Spleen Thyroid Trichea Urinary Bladder General Comment -Pale mottled -Hemorrhagic -Hemorrhagic -Withinnormallimits One of pair present -Not examined,missing -Hapatocytevacuolation,periportal,moderate -Vascularmineralizations,ild Edema, localareas,mild -Not examined,missing -Not examined,missing -Not examined,missing -Not exasinodgmissing -Not examined,missing -Hemosidernsiss,ild -Not examined,missing -Not examined,missing -Mt examined,missing -Rosttissueshave advancedautolyticchanges. Thefollowingtissueswe foundto be withinnormallimits: Kidney,Heart,Testis/EpididysisS,tomach. Animal Number: IR-3843 Sex: Male Group: t 4) FK-392410 pps Fate: (Neek-106)TerminalSacrifice MacroscopicObservations: Testis/Epididysis MicroscopicObservations: Kidney Liver -Lefttestissmall. -Chronicprogressivenophropathy,moderate Pelvicmineralizatiosni,ld -Portalsononucleacrellinfiltratem,ild Hepatocytevacuolitionc,entrilobulars,ild Cystoiddegenerationf,ocal,sild Hep&tKytoalterationv,acuolitedo,ultifocal, mild NegalKytosis,minimal Species:Rat Project Number: 0261CROO12 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacrmoPic and NitroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924; Two Year Oral Toxicity-OncogenicityStudy in Rats --------------------- - ----------------- ------------------Animal Number: IN-3843 Sex: Male Group: 41 FN-3q24 10 ppe Fate: (Weekz106) TerminalSacrifice Table: 2 Kicroscop@AOcbservations (continued): Lung Pancreas Testis/Epididysis Thyroid -Vascularmineralizations,ild -Acinar atrophy, @;Ald -Tubuleatrophy,ispersatogenesisu,nilateral, marked -Ultit.Dbranchicaylst The followingtissues*ere found to be withinnormal limits: Spleen, Heart,Prostate,Stomach,UrinaryBladder,Adrenal,Parithyroid,Trachea,Esophagus, SalivaryGland,Pituitary. ------------------- --- --- --------------------- --- -- -- Animal Number: IR-3B44 Sex: Nale Group: 4) FM-35&1410 ppe Fate: (Week=106) TerminalSacrifice. NacroscapicObservations: Kidrey MicroscopicObservations: Esophagus Heart Kidney Liver Lung Pancreas Parathyraid Prostate Thyroid -Fluidfilledcyst on left kidney. -Not examined,missing -Myocarditis,chronicnonsuppuritive, oultifocalm,ild -Chronic progressivenophropathy,moderate -Portalsononuclearcell infiltrate,sild Portalbile ductproliferationm,ild Hepatocytevacuolation,oultifocal,mild Negalocytesis,minimal -Vascularmineralization,minimal -Acinaratrophy, moderate Polyarteritis,moderate -Not examined,not in plane of section -Hyperplasia,fkal, moderate -Hyperplasia,C cell, moderate The followingtissueswere found to be withinnormal limits: Spleen, Testis/EpididysisS,tomach,Urinary Bladder,Adrenal,Trachea,SalivaryGland,Pituitary. - - ------------------------------- ------- --- -- -- Animal Number: IR-3645 Sex: Nale Group: 4) Ffl-392410 ppe Fate: (kekz 106)TerminalSacrifice Nacroscopic Observations: Eye NicroscopicObservations: Eye -Righteye atrophied,no tissuesto be taken -Retinalatrophy,localareas,sild Species: Rat Project Number: 0211LItOO12 Smarized STAR Page: 242 4-33 SuseariziiSdingleTabulatedAnimalReport (continued) IndividualNikcroscopiacnd NicruscopicObservations RikerLaboratoriesI,nc. 3K FN-3924:Two Year Oral Toxicity-bcoginicitSytudyin Rits Table:2 Animal Number: IR-3845 Sex: Nale Group: 4) FN-392410 ppe Fate: (Neekz106)TerminalSacrifice NicroscopiOcbservations(continued): Heart Kidney Liver Lung Parithyroid -Nyocarditisc,hronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropathy,sild -Portalamonuclearcellinfiltratea,ild Portalbileductproliferatiosni,ld NogilKytosits,ild -Parivasculasronanucleairnfiltrates,ild -Notexamined,not in planeof section The followingtissues*erefoundto be withinnormallimits: Spleen,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Trachea, Esophagus,SalivaryBlind,Pituitary,Pancreas. - -------- ------------ - - ------ -- - ---- ----------------- Number: IR-3P6 Sex: Nale Group: 41 FN-3924 10 ppe Fite: (Week-106)TerminalSacrifice NacroscopicObservations: NicroscapicObservations: Adrenal Kidney Liver Lung Pituitary Trachea -No visiblelesions. -Corticaldegenerationf,ocal,mild -Chronicprogressivenephropathy,mild -Portalsonanucleacrellinfiltratem,ild Repatocytealterationv,acualated,oultifocal, mild Negalacytosis,minimal Necrosis,focal,minimal -Pneumoniai,nterstitialc,hronic,focal,sild Perivasculamrnonuclearinfiltrates,ild -Cyst,parsdistalis -Tracheitisc,hronic,moderate The followingtissueswerefoundto be *ithinnormallimits: Spleen,Heart,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Thyroid,Parathyraid, Esophagus,SalivaryGlind,Pancreas. ------ ---- -------- ---- ----------------------------------------------------------- Species:Rat Project Number: 0281CRO12 Susarized STAR Page: 243 434 SummarizedSingleTabulatedAnimalReport (continued) Individualkcroscapicand RicroscapicObservations RikerLaboratoriesI,nc. 3K Ffl-3924T:wo YearOral Toxicity-OncogeniciSttyudy in Rits Table:2 AnimalNumber: IR-3647 Sex: Kale Group: 4) FN-392410 ppe Fate:(Veek-1-00)Sacrificeidn extromis NacroscopicObservatims: SoftTissues(leg) Liver HicroscapicObservations: Bane Ki*dney Liver Long Parithyroid Pituitary Thyroid UrinaryBladder -Swollenrightand lefthindfeet. -Possiblsylightlymottled. -Arthritisy,novitisj;ointsb,ilateralm,ild -Chronicprogressivenephropathym,ild Cyst,cortical -Portalsmanuclearcellinfiltratem,ild -Vasculamrineralizatiomni,ld Parivascularmonuclearinfiltratea,ild -Not examined,missing -IWIRDSA -Mt examined,missing -Calculus The followintgissuesmerefoundto be withinnormallimits: Spleen,Heart,Testis/EpididyaiPsr,ostate,Stomach,Adrenal,Trachea,Esophagus, Silivary61,indP,ancreas. AnisalNuaber:IR-3940 Sex: Male Group: 4) FK-392410 ppe Fite:lneekx106)TerminalSacrifice MicroscopicObservations: Pituitary Adrenal MicroscopicObservations: Adrenal Kidney Liver Lung Lymph Node Pituitary Prostate Testis/Epididysis -Raised&ass,0.5ce dia. -Enlarged -Nodularhyperplasiac,ortex,marked Oneof pairpresent -Chronicprogressivneephropathys,ild -Portaslononucleacrellinfiltratem,ild Portalbileductproliferatiomni,ld Negalocytosism,inimal -Vasculamrineralizatiosni,ld Pneumoniai,nterstitiaclh,ronico,ultifocil, mild Alveolarmacrophageso,ultifocalm,ild -Sinusaidaelctisia,moderate -Adenosa -Hyperplasiaf,ocal,moderate -Polyarteritimsi,ld Thefollowintgissuesare foundto be withinnormillimits: Spleen,Heart,Stomach,UrinaryBladder,Thyroid,ParithyroidT,rachea,Esophagus, --- - ---------------------------------- --- --- --- -- Species:Rat Project Number: 0281CROO12 Sumw izod STAR Page: 244 435 SummarizSeidnglTeabulateAdnimaRleportfcontinued) IndividuMaalcroscopaincdMicroscopOibcwvations RikerLaboratoriIensc,.3H Ffl-3924T:oo Year Oral Toxicity-(McalmicitSytudyin Rats Table:2 AnisilNumber: 12-3648 Sex:Nile Group: 4) FN-3924 10 ope Fate: (Veekz106)TerminalSacrifice MicroscopicObservations(continued): The folloningtissueswe foundto be Nithinnormallimits(continued): SalivaryGland, Pancreas. ------ ------- -- - -- --- ------------------- ---- - -- ---------------------------Animal Number: IR-3649 Sex: Nile Group: 4) FN-3924 10 ppe Fate: (WeeksiO6) TerminalSacrifice MacroscopicObservations: NicroscapicObservations: Adrenal Kidney Liver Lung Pirathyroid Pituitary -No visiblelesions. -Corticalvacualation,local areas,sild Nodularhyperplasia,cortex,focal,sild -Chronicprogressivenephropithy,sild -Portaloononaeloatrell infiltrates,ild Portalbile ductproliferations,ild Nepatacytovitcuolationc,entrilobulirs,ild Regalocytosis,mild -Yncular mineralization,minimal Hemorrhage,oultifocal,mild -Not examined,not in plant of section -Adenosa The follovingtissuesNere foundto be vithinnormallimits: Spleen,Heart, Testis/EpididysisP,rostate,Stomach,Urinaryfladder, Thyroid,Trachea, Esophagus,Salivary Gland, Pancreas. ----------------------------------------------- - -- ---------- ------------------- Anisal Nuaber: IR-3850 Sex: Nale Group: 1 4) FN-3q24 10 ppe Fate: fneeks106) TerminalSacrifice MicroscopicObservations: Pituitary NicroscapicObservations: Liver Lung Parathyraid Pituitary Prostate Spleen -Raisedcircular@ass, 0.5 ce dia. -Portalsonanuclearctillinfiltrate,mild Pvtal biltductproliferations,ild Repatacytoalteration,vicuolited,oultifocal, mild -Vascularmineralizations,ild Alveolareacrophages,oultifocal,mild -Not examined,not in plantof section -Adenosa -Prostatitisagcute,sild -Hemosiderosis,sild Species: Rat, Project Number: 0281CROO12 Summarized STAR Page: 245 Sumarized SingleTabulatedAnimalReport(contioutd) IndividualNacroscapicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-WcogenicitSytudyin Rats Table:2 Animal Number: IR-3650 Six: Kale Group: 4) FN-392410 ppe Fate: (Weeks106)TerminalSacrifice MicroscopicObservations(continued): The followingtissueswere found to be withinnormallimits: Kidney,Heart, Testis/EpididysisS,tomach,UrinaryBladder,Adrenal,Thyroid,Trachea, Esophagus, Salivary Bland, Pancreas. ---------------------- --- ----- --- -- - --- --- -- Animal Number: IR-3851 Six: Kale Group: 4) FN-3924 10 ppe Fite: (Week=106) TerminalSacrifice NacroscopicObservations: Adrenal Testis/Epididysis Microscopic Observations: Adrenal Heart Kidney Liver Lung Pituitary Te' stis/Epididysis -Leftenlarged,I co dia.,dark. -Lefttestissmall. -Pheochrosocyto",malignant,bilateral -Myocardialfibrosis,oulti4ecal,mild -Chronic progressivenophropathy,moderate -Portalsononvelearcall infiltrate,minimal NepitOCyttVACU01iitiOD@,UltifKill sild Nep&tKyttAlteration,vacuolated,oultifocal, sild -Yarculiisrintralizatidnm,inimal -Hypirplasias,ultifocalp,arsdistalis,sild -Tubuleatrophy,isper"togentsis,unilateral, marked The followingtissues*ere found to be withinnormallimits: Spleen, Prostate, Stomach, UrinaryBladder,Thyroid,Parithyroid,Trachea,Esophagus, SalivaryGland, Pancreas. ------- ----------------------- -- ---------------------- -- ------------------------------ Anisal Number: IR-3832 Six: Hale Group: 4) FN-3924 10 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Heart Kidney Liver -No visiblelesions. -NyKarditis,chronicnonsuppuratives,ild -PelvicsineralizationG,UItifKA1, mild -Portaloononuclearcell in4iltrate,mild .HePatOCYttVaCUOlati0ftO,UltifKil, Minimal Hipatocytoalteration,vicuolated,oultifocal, sild Negalocytosis,sild Species: Rat Project Number: 0281CROO12 Su"arized STAR Page: 246 437 SummarizedSingleTabulatedAnimalReport(continuedy IndividualMacroscopicand Microscopicobservations Riker LAboratories,Inc. 3H Ffl-3q24:Too Year Oral Toxicity-OncogenicitSytudy in Rats - --------Animal Number: IR-3852 Sit:Mile Fate: (Week=106) TerminalSacrifice Group: 1 4) FII-392410 pps Table: 2 MicroscopicObservations(continued): Lung -Vascularmineralization,mild Perivascularsmanuclear infiltrate,mild The followingtissuesare found to be withinnormallimits: Spleen,Tesfis/EpididysisP,rostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,Salivary gland,Pituitary,Pancreas. ------------ -- --- ---------------- Animal Number: IR-3853 Sex: Halt Group: 4) FN-3924 10 ppe Fate: (Neekz106) TerminalSacrifice Microscopic Observations: MicroscopicObw Heart Kidney vations: Liver Lung Testis/Epididysis Trachea -No visiblelesions. -NYK&rditis, chronicnonsuppurative,mild -Chronicprogressivenephropathy,mild Pelvicmineralizationm,ild Pyelitis,acute,sild Hyperplasia,pelvicepithelium,mild -Portalsononotleacrell iafiftritim,ild Portalbile duct proliferations,ild Nepitacytealterition,vacuolated,oultifocal, minimal Negalacytosis,minimal -Vascularmineralization,minimal Alveolarmacrophages,oultifocal,mild Perivascularsononuclearinfiltrate,sild -Vascularmineralizatioa,minimal -Tracheitisc,hronic,mild The followingtissuessere found to be withinnormal limits: Spleen,Prostate,Stomach,Urinary Bladder,Adrenal,Thyroid,ParithyrDid,Esophagus, SalivaryGland,Pituitary,Pancreas,Eye. ---------- --- -------------- ----------------------------------------- --------------- - Animal Number: IR-3854 Sex: Kale Group: t 4) FM-3924 10 ppe Fate:-(Meekx106) TerminalSacrifice Microscopic Observations: Pituitary -Raiseddark mass,0.5 ce dia. Kidney -Pale Microscopic Observations: Heart -Nyocarditis,chronicnonsupporatived,iffuse, moderate --------------------- ---------------------- Species: Rat Project Number: 0201CRO12 Summarized STAR Page: 247 438 SummarizSeidnglTeabulateAdnimaRleport(continued) IndividMuaaclroscopiacndMicroscopOibcservations RikerLaboratoriIensc,.3N FN-3924T:woYearOralToxicity-OncovenSitcuidtyiynRats Table2: Animal Number: IR-3854 Sm: Nalt Group: 4) FN-392410 ppe Fit#: lneeka106)TerminalSacrifice MicroscopicObservations(continued): Kidney Liver Lung Pancreas Pituitary SalivaryGland Testis/Epididysis -Chronicprogressivenephropathy,marked -Portalsononucleacrtllinfiltratem,ild Portalbileductproliferationm,ild Nepatocytoalteration,vacualiktedo,ultifocal, mild -Vascularaineralizatiosni,ld Hemorrhage,@UltifKal,sild -Acinaratrophy,aild -Adenoma -Not examined,missing -Polyarteritimsi,ld The followingtissueswerefoundto be withinnormallimits: Spleen,Prostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Parathyraid,TrachealEsophagus. ----------------------- AnisalNumber:IR-3M Six: Nale Group: 4) FN-3924 10 ppe Fate: (Neekz106)TerminalSacrifice MacroscopicObservations: IicroscopicObservations: Adrenal Kidney Liver Lung Pirathyroid Pituitary Testis/Epididysis Thyroid -No visiblelesions. -Corticalvacuolitionl,ocalareas,mild Nodularhyperplasiac,ortex,sild -Chronicprogressivenophrdpathy,mild Pelvicmineralizatiosni,ld Calculus,Pelvic -Portalmanonucleacrellinfiltratem,ild Pwtal bileductproliferatiomni,ld Cystoiddegeneration,4ocal, minimal Hipatocytaelterationv,acualatedo,ultifocal, sild -YaKUI&r minerilizationm,ild Alveolareacrophaless,ild -Not examined,missing -Not examined,missing -Vascularmineralizationm,oderate -Not examined,missing The followingtissueswere found to be within normal limits: Spleen,Heart,Prostite,Stomach,UrinaryBladder,Trachea,Esophagus,Salivary61and,Pancreas. Species:Rat ProjectNumber:OnICROO12 SummarizedSTAN Page:248 439 Sumarized SingleTabulatedAnimalReport(continued) IndividualNacroscoPicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3q24:Two Year Oral Toxicity-OncoleniciSttyudyin Rats Table:2 Animal Number: IR-3856 Sex: Kale Broup: 4) FN-3924 10 ppe Fate: (Week=106)TerminalSacrifice MacroscopicObservations: Pituitary Liver MicroscopicObservations: Heart Kidney Liver Lung Pituitary SalivaryGland Spleen Stomach Te5tis/Epididymis Thyroid -Largehemorrhagicmass,1.2 x I ca. -Pileand mottled. -Myocardiaflibrosiso,ultifocalm,ild Nyocarditis,chronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropathy,moderate Pyolitis,acute,minimal -Portalemanuclearcellitt4iltratmei,ld Portalbileductproliferationm,ild Nepatocytevacualitionp,eriportal,marked -Vascularsintralizatiomni,ld -Adenomi -Not examined,missing -Mmsideresis,sild -Ulcer -Vasculasrineralizitims,ild -HyperplasiaC,cell,focal,mild The followingtissueswere foundto be withinnormallimits: Prostate,UriniryBladder,Adrenal,Parathyroid,Trachea,Esophagus,Pancreas. -------------------------------------- ---------- ---- - ---------- -------- Animal Nuaber:IR-3057 Sex:ble Sroup: 1 4) FN-392410 pps Fate: lweekz106)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Heart Kidney Liver Lung Testis/Epididysis ---------- ---- --- ----- ---- -No visiblelesions, -Corticaldegenerationf,ocal,sild -Myocardiaflibrosisd,iffuse,sild Nyocarditis,chronicnonsuppurative, miltifocals,ild -Chronicprogressivenephropathy,minimal -Portalsononucleacrellinfiltrates,ild Portalbileductproliferatiomni,ld Nepatocytevacuolitiono,ultifocals,ild Ntg&IKYtOSiS, Minimal -Vascularsineralizatiosni,ld Alveolarucrophages,@UltifK&I,mild Perivisculasrononacleairnfiltratem,ild -Vascularsintralizatiosni,ld Species:Rat ProjectNumber:0281CM12 Sunarized STAR Page: 249 440 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-OncoliniciSttyudyin Rats Animal Number: IR-3057 Sax: Nale Group: 4) FN-392410 ppe Fite: (Weeks106)TerminalSacrifice Table: 2 MicroscopiOcbservations(continued): Thefollovingtissuesmerefoundto be vithinnormalliaits: Spleen,Prostate,Stomach,UrinaryBladder,Thyroid,Parithyroid,Trachea,Esophagus, SalivaryGland,Pituitary,Pancreas. -- --------------------------- ---- ------ Animil Number:IR-3856 Sex: Nale Broup: 4) FM-3924 10 ppe Fite: (Weekz106) TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Kidney Liver Lung -No visiblelesions. -Pheachrosocytm,benign,unilateral -Chronicprogressivenephropathy,mild -Portalsoi=uclearcallinfiltratea,ild Portalbileductproliferatiooni,ld Negalocytosisominimal -Vascularmineralizationm,ild Alveolarucrophages,oultifecals,ild Perivasculamrnonucleirinfiltrates,ild The follamingtissueswert foundto be mithinnormallimits: Spleen,Heart,Testis/EpididysisP,rostate,Stomach,UrinaryBladder,Thyroid,Parathyroid, Trachei,Esophagus,SalivaryBlind,Pituitary,Pancreas. - - -------------------------------- - - --- - ---- - ------------------------ -- AnisilNumber:IR-3859 Sex: Nale Group: 4) FN-3924 10 ppe Fate: (Weekx106)TerminalSacrifice MicroscopicObservations: Testis/Epididysis MicroscopicObservations: Adrenal Heart Kidney Liver Lung Pituitary Testis/Epididysis ------------ -Bothtestesenlargeddue to extensiveedeti. -Corticalvacoolationl,ocalareas,moderate -Nyocarditisc,hronicnonsuppurative, oultifocalm,ild -Chronicprogressivenephropathy,sild -Portalmonanucleacrellinfiltratem,ild Portalbileductproliferationm,ild Cystoiddegenerationf,ocal,mild -Vascularmineralizationm,inimal -Adenoss -Tubuleatrophy,ispersatoginesibsi,lateral, marked --- -- -- - Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 250 441 Sumarized SingleTabulatedAnimalReport tcontinnedi IndividuaMlacroscopiacnd NicroscopiOcbw vations RikerLaboratoriesI,nc. 3H FN-3924:Too Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Animal Number: IR-3859 Six:Halt Group: 4) FN-3924 10 ppe Fate: lkeekx106)TerminalSacrifice MicroscopiOcbservations(continued): The followingtissueswere foundto be withinnormallimits: Spleen,Prostate,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachei,Esophagus, SalivarySland,Pancreas. ----------------------------------- --- --- - - ------- Animal Number: IR-3860 Sex:Halt Group: 4) Ffl-392410 ppe Fite: (Weeka106)TerminalSacrifice MacroscopicObservations: SoftTissues(neck) Pituitary MicroscopicObservations: Heart Kidney Liver Lung Pancreas Pituitary SoftTissues(neck) -Firemass,2.51 2.2ca, leftsideof neck. -Raisedmass,0.6 co dia. -Nyocarditisc,hronicnonsuppurative, oultifocals,ild -Chronicprogressivenephropithys,ild Pelvicsintralizatiosni,ld -Portalsononucleacrellinfiltratem,ild -Neg&IKY!OSiS, minimal -Vascularsihoralizationm,ild Alveolarsacrophqes,oultifocals,ild -Aciniratrophy,sild -Adenosa -Fibroma The followingtissuesmerefoundto be withinnormallimits: Spleen,Testis/EpididysiPsr,ostate,Stomach,UrinaryBladder,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,SalivaryGland. --- ------------------------------------------- -- ---- -- --- ------------------------ Animal Number: IR-4971 Six:Female Group: 4) FM-3924 10 ppe Fate: (Weekz 76) FoundDead MicroscopicObservations: MicroscopicObservations: Adrenal Lung Kassary Gland Ovary Pituitary -No visiblelesions -Corticalvacualationl,ocalareas,moderate -Vascularmintralizaticms,ild -Not examined,missing -Vithinnormallimits One of pairpresent -Adencei The followingtissueswere foundto be withinnormallimits: Spleen,Liver,Kidney,Heart,Uterus,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea, ---------------- --- - ----------------------------------- Species:Rat Project Number: 0281CROO12 Suseari?edSTAR Page: 251 442 SummariSziendglTeabulatAendimaRlepor(tcontinued) IndividuMailcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3N FN-3924T:woYearOralToxicity-OneagenSitcuidtyiynRats --- --------AnimalNumber: IR-4671 Six:Fesile Group: 4) FN-3924 10 ppe Fate: (Weekz 76) FoundDead Table2: MicroscopicObservations(continued): The follomingtissueswerefoundto be withinnormallimits(continued): Esophagus,Salivarygland,Pancreas. ------------------ ------------------------ - --- -- Animal Number: IR-4872 Sex: Female Broup: 4) FN-392410 pps Fate: (Week=105) TerminalSacrifice MicroscopicObservations: Pituitary Skin MicroscopicObservations: Adrenal Liver Lung Parithyraid Pituitary Spleen -Miss,0.7 ce dia. -Hairloss,abdomenand forelith. -Sinusoidielctisia,cortex,moderate -Nepatocytveacuolationo,ultifocal,minimal -Vascularmineralizationm,ild -Not examined,not in planeof section -Adencoa -Hososiderosissi,ld The followingtissuesmerefoundto be withinnormallimits: Kidney,Heart,Uterus,Ovary,MammaryBland,Stomach,UrinaryBladder,Thyroid,Trachei, Esophagus,SalivaryBland,Pancreas,Skin. --------- --------------- - -- -------- Animal Number: IR-4873 Sex:Female Broup:1 4) FN-392410 ppe Fite: (Week=105)TerminalSacrifice MacroscopicObservations: MicroscopicObservations: Adrenal Heart Kidney Liver Lung -No visiblelesions. -Sinusoidalortasia,cortex,moderate -Myocardial fibrosis, local areas, moderate -Chronic progressive nephropathy,sild -HepatKyte vacuolition,oultifocal, sild Hepatocyte alteration,vacualated, local areas, vild -Vascular mineralization,sild Hemorrhage, local areas, moderate The following tissues *ere found to be within normal limits: Spleen, Uterus, Ovary, Mammary Gland, Stomach, Urinary Bladder, Thyroid, Parathyraid, Trachei, Esophagus,Salivarygland,Pituitary,Pancreas. --------- --- - - ------------------------------ species:Rat Project Number: 0281CROO12 Summarized STAR Page: 252 443 SuesarizedSingleTabulatedAnimalReport (continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Tvo YearOral Toxicity-OncogeniciSttyudyin Rats Table: 2 Animal Number: IR-4874 Sex: Female Broup: 1 4) FN-392410 ppe Fate: lneeka 90) FoundDead MacroscopicObservations: Pituitary MicroscopicObservations: Kidney Liver Pituitary Spleen -Mass,i 1 0.7 ca. -Chronicprogressivenephropathy,mild -Portalsononucleacrellinfiltrates,ild Portalbileduct proliferationm,oderate Nepatocytovacualitionp,eriportal,moderate -AdenoBa -Hemosideresiss,ild The follovingtissueswe foundto be Nithinnormallimits: Heart,Lung, Uterus,Ovary,MammaryBland, Stomach,UrinaryBladder,Adrenal,Thyroid, Parathyroid,Trachea,Esophagus,SalivaryGland,Pancreas. ---------------------------------------------------------- Animal Number: IR-4675 So Feeale Group: 4) Ffl-392410 pps Fate: (Weekz104) Found Dead MicroscopicObservations: Skin Liver Pituitary -Urge saiis-,11t 13cA, rightside. -@hli-andsattlid.-Darkred mass. MicroscopicObservations: Adrenal -Corticavlacualitionl,ocalareas,sild Sinuscidalectasia,tortes,moderate Esophagus Eye Kidney -Not examined,missing -No diagnosis,inadequatesection -Pelvicsintralizatitm,oderate Dne of pairpresent Liver -Portalbileductproliferatiosni,ld Necrosis,centrilobularm,ild Lung -Alveolareacrophiges,sultifocals,ild Thrombus,sulti4ocal,moderate Hastary Gland Ovary Pancreas -Fibroadenoss -Not examined,missing -Not examined,missing Parathyroid -Not examined,missing Pituitary -Not examined,missing SalivaryGland -Not examined,missing SPIm -Hetosiderosism,oderate Thyroid -Not examined,missing Trachea -Not examined,missing UrinaryBladder -Not examined,missing - -- -- --- --------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR*Page: 253 444 Sumrized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerUboratories,Inc. 3H FN-3924:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table:2 AnimalNumber: IR-4875 Sax: Female Group: 4) FN-392410 ppe Fate: (Weak-104) Found Dead MicroscopicObservations(continued): The followingtissueswere foundto be withinnormallimits: Heart,Uterus,Stomach. --- --------------------------------------- ----- ------ Animal Nuaber'.t IR-4876 Sex: Female Broup: 4) W3924 10 pps Fate:theeka105)TerminalSacrifice MicroscopicObservations: Mammary Gland MicroscopicObservations: Adrenal Liver Lung Mammary Bland Thyroid Uterus -Lobularmass,5.5 1 5 x 2 ce, rightaxilla. -Sinusoidalectasia,cortex,moderate -Hapatocytaelterationv,acuolitodf,ocal, sild -Vasculasrintralizatioini,ld 4ibroadenosa -Ultimobranchiaclyst -Polyp The followingtissueswerefoundto be withinnorul limits: Spleen,Kidney,Heart,Ovary,Stomach,UrinaryBladder,Parathyroid,Trachea,Esophagus, SalivaryGland,Pituitary,Pancreas. --------------------------------------------------------------------------------- Animal Number: IR-4877 Sex:Female Group: 1 4) FN-392410 ppe Fate:(Weekz 84) Sacrificeidn extramis MacroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Pituitary SalivarySland Spleen Thyroid -Raisedmass, I ce dia. -Sinusoidaelctisia,cortex,mild -Chronicprogressivenephropathy,mild Pelvicsineralizationm,inimal -Repatocytevacuolation,pariportal,moderate -Vascularsintralizatiosni,ld Perivasculamranonucleairnfiltrates,ild Hemorrhage,oultifocal,mild -Adenoss -Not examined,missing -Nmosiderosis,mild -Ultimabranchiaclyst The followingtissueswe foundto be withinnormallimits: Heart,Uterus,Ovary,Ramary Gland,Stomach,UrinaryBladder,Parathyroid,Trachea,Esophagus, Species:Rat Project Number: 0261CROO12 Snaarized STAR Page: 254 445 Sumarized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObwvations RikorLaboratoriesI,nc. 3N FN-3924:Too YearOral Toxicity-OncoginiciSttyudyin Rats -- ------------- ---- -- - ---- -Animal Number: IR-4677 SIX: Female Group: 4) Ffl-392410 pps Fate:(Neekz 64)Sacrificeidn extresis Table:2 MicroscopiOcbservations(continued): The followingtissueswerefoundto be withinnormallimits(continued): Pancreas. ------------- --------------------- - - -------------------------- --------- Animal Number: IR-4876 Sex: Female Broup: 4) FN-3924 10 ppe Fate: (Week-1@05) TerminalSacrifice MacroscopicObservations: Mammary Gland Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung,. Mammary Bland Ovary Pituitary Uterus -Firemiss,6 1 4 1 2 col rightasilla. -Raisedeass,0.5 ce dia. -Sinusaidaelctisia,cortex,unilateral, moderate -Pelvicsineralizitionm,oderate Pyelitis,acute,unilateralm,ild -Nepatocytevacuolationp,eriportalm,ild Repatocytealterationv,icualitedf,ocal, sild Vascularsintralizatiomni,ld Alveolareacrophageso,ultifecal,mild Pneumonia,interstitialc,hronic,oultifocal, sild -Fibroadenota -Tubularhyperplasiab,ilateral,mild -Adenosa -Cysticglands,moderate The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Stomach,UrinaryBladder,Thyroid,Parathyraid,Trachea,Esophagus, SalivaryBland,Pancreas. --------------------------------------------------------------------------------- Animal Number: IR-4079 Six: Female Sroup: 4) FN-3924 10 ppe Fite: (Weeka 84) FoundDead MacroscopicObservations: SoftTissues(199) -Mass,7 1 3 x 2 ce, grittytexture,lefthind leg. Liver -Slightlyenlargedwith multiplepale lesions, 0.1- 0.5 ce dia.,on all lobes. Pituitary -Hemorrhagicmass, 0.3 1 0.5 ce. MicroscopicObservations: Adrenal -Sinusaidaelctaria,cortex,mderate ------------------------ ------------------------------ Species:Rat Project Number: 0281CROO12 Sumarized STAR Page: 255 446 SummarizedSingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3q24:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Table:2 Anisal Number:IR-4879 Sex:Fmlt Group: 4) FN-3924 10 ppe Fitt:(Veekx 84) FoundDead MicroscopicObservations(continued): Heart Kidney Liver Lung Pancreas Parathyroid Pituitary Skin Spleen Thyroid -Malignantlyaphona,histiocytic -Proteinresorptiodnroplets,sild -malignantlyapholathistiocytic Necrosis,localareas,moderate -Vascularmineralizations,ild Malignantlyaphou,histincytic Hemorrhagel,ocal artaspmild -Mt examined,missing -Not examined,missing -Adenosa -MalignantIYSPHOMA,hiStiKYtiC Brosslesionfrom lefthindleg. -Nesosidorosiss,ild -Not examined,missing The followingtissueswere foundto be withinnormallimits: Uterus,Ovary,MammarySland,Stomach,UrinaryBladder,TrachealEsophagus,Salivarygland. ------------------------- ---------- - - ---- --- ------ ------ Animal Number: IR-@4990 Sex:Femile Group: 4) FK-392410 ppe Fate: (Week--78) FoundDead MacroscopicObservations: Uterus Pituitary MicroscopicObservations: Kidney Liver Lung Mammary Gland Pancreas Pituitary SalivaryGland Spleen -Bothhornsfilledwithdarkfluid. -Hemorrhagicmass, 0.4 ce dia. -Pelvicsineralizatiosni,ld -NepatDrytveacualationp,eriportal,mild -Vascularmineralizations,ild -Adenocarcinosa -Not examined,missing -Adenusa -Not examined,missing -Hemosiderosis,moderate The followingtissueswere foundto be withinnormallimits: Heart,Uterus,Ovary,Stomach,UrinaryBladder,Adrenal,Thyroid,Parithyroid,Trachea, Esophagus. -- - ---------- --------------------------------------------------------------- Sptcies:Rat Project Number: 0291CROO12 SmarizW STAR Page:256 447 SumarizeSdinglTeabulatAendimaRleport(continued) IndividuMaalcroscopaincdNicroscopOibcservations RikerLaboratoriIensc,.3N FN-3924T:ooYearOralToxicity-OncogenSitcuidtyiynRats Table2: Animal Number: IR-4881 Sex: Female Group: 4) FN-392410 pps Fate: (Neeka105)TerminalSacrifice Microscopic Observations: Mammary Gland Uterus MicroscopicObservations: Adrenal Heart Kidney Liver Lung Massiry Gland Ovary Parathyroid Uterus -Labular mass, 5 1 3 1 2 ce, right axills. -Cysticlesion,2 1 0.6 ce, lefthorn. -Sinusoidaelctasia,cortex,mild -Nyocarditisc,hronicnonsuppuritive, oultifocalm,ild -Chronicprogressivenephropathy,minimal -Mpatocytevacualationo,ultifocals,ild Hepatocytealteration,vacualated,focal, sild -Vascularsineralizatiosni,ld -Lobularhyperplasia -Cyst,unilateral -Nottxaoined,not in planeof section -Polyp The followingtissueswere foundto be withinnormallimits: Spleen,Stomach,Urinaryflidder,Thyroid,Trachea,Esophagus,SalivaryGland,Pituitary, Pancreas. Animal Number: IR-4882 Sex: Female Group: 4) FN-3924 10 ppe Fate: (Meek=105)TerminalSacrifice MacroscopicObservations: Mammary Sland MicroscopicObservations: Adrenal Heart Liver Lung Mammary Gland -Small mass, 2 cm dia., right inguinal; large Bass 5 x 5 s I ce, left ingainal; miss, 4 1 4 1 1 ce, right axillary -Sinusaidaelctisia,cortex,marked -HyDcarditis,chronicnonsuppurative, oultifocals,ild -Portilsonanucleacrellinfiltratem,inimal Portalbileductproliferationm,inimal Heiiatopoiesiesx,tratedullarym,inimal -Yascule sineralizatiomni,ld Pneumoniai,nterstitialc,hronic,oultifocal, aild -Fibroadenota Salactactle Lobularhyperplasia Labularhyperplasia Species:kit ProjectNumber:0281CROO12 Smearized STAR Page:257 448 Sumarized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rits Table:2 Animal Number: IR-4882 Sex: Female Group: 4) Ffl-392410 ppe Fate:tvmk- 105)TerainalSacrifice MicroscopicObservationslcontinued): Ovary Uterus -Cyst,bilateral -fterplasiie,ndontrial,moderate The followingtissueswere foundto be withinnormallimits: Spleen,Kidney,Stomach,UrinaryBladder,Thyroid,Pirithyroid,Trachea,Esophagus, SalivaryGland,Pituitary,Pancreas. --------------------------------- Animal Number: IR-4983 Sex:Female Group: t 4) FN-392410 ppe Fite: (Week-1-05)TerminalSacrifice Microscopic Observations: Pituitary Mammary Gland MicroscopicObservations: Adrenal Kidney Liver HassiryGland Ovary Pancreas Pituitary SalivaryGland Spleen -Mass,I co dia. -Cysticlabularmass,5 x 3.51 2 ca, right &mill&;labularmass,4 s 4 1 3 ce, rightinguinal;lobularmass,5 1 5.5 x 2.5 CA,leftinguinal. -Sinusoidaalctasia,cortex,mild -Pelvicmineralizatioani,ld Nephrosis,tubular,marked -Portalnorionuclecaerllinfiltratem,ild Portalbileductproliferationm,ild Nesatopoitsise,xtramedullarym,inimal -Fibroadenosa salactocile Adenocarcincet Fibroadenoma -Not examined,missing -Hyperplasiai,sletcell,sild -Adenosa -Not examined,missing -Hesatopciesise,xtrasedullaryi,ncreased, moderate The followingtissueswere foundto be withinnormallimits: Heart,Lung, Uterus,Stomach,UrinaryBladder,Thyroid,Parathyraid,Trachea,Esophagus. - - - -------------------------- ------------------------- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 258 449 SummarizedSingleTabulatedAnimalReport lcontineed) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year OralToxicity-OncoleniciSttyudyin Rats -- --- --- --AnimalNumber: IR-4894 Box:Fmle Group: 4) FM-392410 ppe Fate: (Netkx105)TerminalSacrifice Table:2 MacroscopicObservations: Mammary Bland Kidney Uterus MicroscopicObservations: Adrenal Heart Kidney Liver Lung Mammary Bland Ovary Pancreas Pituitary SalivaryBland Spleen Uterus -Largelobularmass,10 x 8 1 5 ce, perineal eta. -Congenitaalbsenceof leftkidney;right kidneyenlargedwith smallcysts. -Congenitalabsenceof leftuterusand ovary; rightside appearsnormal. -Sinusaidalectasia,cortex,marked -Myocardiaflibrosis,localareas,sild -Chronicprogressivenephropathy,moderate Hydronephrosisb,ilateral -Hisatopoitsise,xtramedullarym,inimal -Hyptrplasias,eptalcell,focal,mild 4ibroadencea -Cyst -Not examined,missing -Not examined,missing -Not examined,missing -Hosatopoitsise,xtrasidullaryi,ncreased, sild -Cysticglands,moderate The followingtissueswere foundto bt withinnormallimits: Stomach, UrinaryBladder,Thyroid,Parathyraid,Trachea,Esophagus. --- ------------------------------------- -- AnimalNuabtr:IR-4805 Six: Feeale Group: 4) FN-3924 10 ppe Fite: (Week=105)TerminalSacrifice - ------------ --- MacroscopicObservations: Pituitary Mammary Sland -Mass,0.6 ce dia. 4irs mass,2.5x 2 x I CA,leftalilla. MicroscopicObservations: Adrenal ClitoralGland -Sinusoidaelctasia,cortex,sild -Cyst,moderate Inflammation,chronic,moderate Kidney -Chronicprogressivenephropathy,gild Pelvicsintralizatiosni,ld Liver -Repitacytveacuolations,ultifocals,ild kpatocytoalterationv,acuolated, localareas,mild Lung -Yoscularmineralizationm,ild -- ------------- ------------------------------- Species:Rat Project Number: 0261CROO12 Summarized STAR Page: 259 450 SummarizedSingleTabulatedbiul Reportlcontinood) -IndividuaMlacroscopicmW MicroscopicObstrvations RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-OncogenicitSytudyin Rats - --------Animal Number: IR-4665 Sex: Female Broup: Fate: lkeek-105) TerminalSacrifice 4) FN-392410 ppe Table:2 MicroscopicObservations(continued): Hassary Gland Pituitary Thyroid 4ibroadenna -Adenosa -Ultimobrinchiciylst The follomin-g*tissuwesre foundto be withinnormallimits: Spleen,Heart,Uterus,Ovary,Stomach,UrinaryBladder,Parathyroid,Trachea,Esophagus, SalivaryBlind,Pancreas. --- -------------- ----------------- - - -- ------ Animal Number: IR-4986 Sex: Female Broup: 4) FN-392410 ppe Fate: (Netka 99) FoundDead MacroscopicObservations: Mammary Bland Liver Adrenal UrinaryBladder Pituitary MicroscopicObservations: Adrenal Heart. Kidney Liver Lung HassiryBland SalivaryGland Spleen UrinaryBladder Uterus -Largelobularfire @ass,14.5 1 11 1 4.5 ce, -in inguin'iairlea. -Pale -Enlargedwithmultiplepalefoci. -Thickenedulls -Slightlyenlarged -Sinesoidelectasia,cortex,marked -Myocardiaflibrosiso,ultifocals,ild -Pelvicmineralizatiosni,ld Hyperplasiap,elvicepitheliums,ild Hematopoiesise,xtrasedullarym,ild -Necrosis,contrilobularm,oderate -Vascularmineralizations,ild Alveolarsacrophigeso,ultifocals,ild -Fibroadenosa -Not examined,missing -Hematopoiesite,xtrieedullaryi,ncreased, moderate -Epitheliahlyperplasiap,apillaryd,iffuse, marked Areasof squamoussetaplisiaof hyperplastic epithelium. Cystitis,chronic,diffuse,marked -Cysticglands,marked The followingtissuessere foundto be withinnormallimits: Ovary,Stomach,Thyroid,Parathyroid,Trachea,Esophagus,Pituitary,Pancreas. - ---- ------ - ------ ----- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 260 451 SummariSziendglTeabulatAendimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3124:Too Year Oral Toxicity-oncogeniciSttyudyin Rats Table:2 Animal Number: IR-4087 Six: Female Group: 4) FN-3924 10 ppe Fit#:lneek-100)Sacrificeidn extromis MacroscopicObservations: Pituitary Liver MicroscopicObservations: Adrenal Kidney Liver Lung Pituitary Spleen Uterus -Raisedmass,0.8 ca dia. -Appearspale and mottled. -Corticavlatuolitionl,ocalareas,mild -Chronicprogressivenaphropathy,mild Pelvicmineralizationm,ild -Portalsononucleacrallinfiltratem,ild Portalbileductproliferatiomni,ld Hepatocytevacuclationp,eriportal,moderate Hepatacytoalteration,basophilic, localareas,moderate -Vascularmineralizations,ild Alveolarmacrophqes,oulti4ocals,ild Granuloma,4ocal, minimal -Adenosi -Hemosiderosiss,ild -Polyp The followingtissueswere foundto be withinnormallimits: Heart,Ovary,MammaryBland,Stomach,LlrinirByladder,Thyroid,Parathyroid,Trachei,Esophagus, SalivaryGland,Pancreas. --------------------------------------------------------------------------------- Animal Number: IR-48BB Sex: Femile Group: 1 41 F?1-392410 ppe Fate: (Weeks 77) FoundDead MicroscopicObservations: Skin -Hairthinning,dorsalarea and head. MicroscopicObservations: Esophagus Kidney Liver Lung -Not examined,missing -kphritis,acute,focil,sild -NeP&tKYte VaCUOI&tiOn,periportal,sild -Vascularmineralizationm,ild Edema,localWEAS, moderate Pneumonia,bronchopneusoniad,iffuse,acute, Pancreas Piirathyroid SalivaryBland moderate -Not examined,missing -Not examined,missing -Not examined,missing Spleen -Hemosiderosiss,ild Thyroid -Mt examined,missing Trachea -Not examined,missing ------------------ ---- -- ----------------- --- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 261 452 SummarizedSingleTabulatedAnimalReportlcontinved) Individualkcroscopicand NieracepifObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 AnimalNumber: IR-4686 So%:Female Broup: 4) FN-392410 ppe Fate:(Neeka 77)FoundD#ad MicroscopiOcbservation(scontinued): Uterus -Not examined,missing The followintgissueswerefoundto be withinnormallimits: Heart,Ovary,HimearyBlind,Stomach,UrinaryBladder,Adrenal,Pituitary,Skin. ----------------- AnimalNumber: IR-468q Sex:Female Group: 4) FN-392410 ppe Fate:(Weekz105)TerminalSacrifice MicroscopicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Liver Long HisearyGland Pituitary -Hemorrhagimcass,0.7 ce dia. -Sinusoidaelctatia,cortex,marked -Chronicprogressivneephropithym,ild Pelvicmineralizatiosni,ld -Hepitocytvoacuolatioonu,ltifocils,ild -Vasculamrineralizatiosni,ld Pneumoniai,nterstitiaclh,ronic,oultifocal, gild @ Perivisculasrononucleairnfiltratem,ild -salactocele -Adenosa The followintgissueswerefoundto be withinnormallimits: Spleen,Heart,Uterus,Ovary,Stomach,UrinaryBladder,Thyroid,ParithyroidT,rachea, Esophagus,SalivaryBlind,Pancreas. - ------------------------- AnimalNumber: IR-4090 Six:Fitale Group: 4) FN-392410 ppe Fite:(Week=94)Sacrificeidn extresis MicroscopicObservations: Pituitary -Reddenedmass, I ce dia. Liver -Appearspile MicroscopicObservations: Adrenal -Sinusoidaelctasia,cortex,sild Kidney -Chronicprogressivneephropathy,minimal Pelvicmineralizatiomni,nimal Liver Lung -Nepatocytveacualationd,iffuse,marked -Vascularmineralizatiomni,ld Alveolar"crophages,localareas,sild Pituitary -Adenoma SPIM -Nmosiderosisi,iild --- --- ---- --------------------------------- - - ------- Species:Rit Project Number: 0281CROO12 SummarizedSTU Page:262 453 SummarizedSingleTabulatedAniul Report(continued) IndividualMicroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3924:Two Year OralToxicity-OncolonicitSytudyin Rats Table:2 Anisil Number:IR-4890 Sex:Fuile 6roup: 4) Fff-392410 ppe Fate:(kek- 94)Sacrificeidn extrimis MicroscopiOcbservations(continued): UrinaryBladder -Transitionaclellcarcinoma lnvasivesubepitheliatlumor. Highmitotic activity;diffuseinflammatorcyell infiltrate. The followingtissues*ere foundto be withinnormallimits: Heart,Uterus,Ovary,Mammary Gland,Stomach,Thyroid,Parathyroid,Trachea,Esophagus, SalivarySland,Pancreas,Large Intestine, ------------------------------- --- ------ - - AnigalNuaber: IR-4891 Sex:Femile 6roup: 4) FN-3924 10 ppB Fate: (Week=78) Sacrificedin extresis MicroscopicObservations: Skin Pituitary Liver AdrenAl MicroscopicObservations: Adrenal Kidney Liver Lung Pancreas Pituitary -Hiirlosson head,leg,rightear. -Hemorrhagicmass,0.7 s 0.6 ca. -Smallyellowishlesion,0.3s 0.2ca, on the outerareanear fissureof @Wian @lobl -Rightadrenalpossikvyslightlyenlarged. -Nithinnorul liait&L'' One of pair present -Chronicprogressivenephropithy,mild -Hepatocytovacualationc,ontrilabular, localareas,mild -Yascularmineralizationm,ild -Not examined,missing -Adenomi The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Uterus,Ovary,KassiryGland,Stomach,UrinaryBladder,Thyroid,Parithyroid, Trachei,Esophagus,Salivary61and,Brain,Skin. --- ------------- ---------------------------------- - -- -- ------------ AnisalNuaber:IR-4892 Sex: Feeale 6roup:( 4) FN-392410 ppe Fate: (kok- 105)TerminalSacrifice MicroscopicObservations: Pituitary Mammary 61&nd -Mass,0.7 cc dia. -Firemiss,6.51 5.5 1 4.5 cc, rightasilla; lobularmass,3.5 1 3 1 2 cm, in throatarea;firemass,4 1 3 1 3 ca, in left axillik;mass,2 x 1@51 lo2cop - ------------ -------------------------------------- ----- Species:Rat Project Number: 0261CROO12 SummarizedSTM Page: 263 454 SummarizedSingleTabulatedAnimalReport icantinued) IndividualMicroscopicand MicroscopicCbswvations RikerLaboratoriesI,nc. 3H FN-3924:Too Year OralToxicity-OncoginiciSttyudy in Rats Table:2 Animal Number: IR-4892 Sex: Female Group: 4) W3924 10 ppe Fite: (Weeka105)TerminalSacrifice MicroscopicObservationslcontinued): MissaryBland (continued) MicroscopicObservations: Adrenal Kitney Liver Lung Mammary Sland Pancreas Pituitary -leftinguinal. -Sinusaidalactisia,cortex,marked -Chronicprogressivenephropathy,minimal -Portilsononucleicterllinfiltratem,inimal Repatacytevacuolationo,ulti4ocal,mild Nepatacytaelterationb,asophilicf,ocal, sild -Granuloma,focal,mild Hemorrhage,local areas, moderate Yasculirmineralizatiosni,ld -Fibroadennea Fibroadenosa Fibroadenm -Acinaratrophy,moderate -Adenoaa The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Uterus,Ovary,Stomach,UrinaryBladder,Thyroid,Parathyraid,Trachea, Esophagus,SalivaryGland. ------------------------------------------------ ----------------------------- AnisalNumber:IR-4lq3 Sex:Female Group: t 4) FN-392410 ppe Fate: (Week- 81)Sacrificeidn extresis MacroscopicObservations: Pituitary MicroscopicObservations: Adr nal Liv:r Lung Parathyroid Pituitary Spleen -Enlargeddue to a red mass,1.4 1 0.7 ca. -Sinusaidaelctasia,cortex,moderate -Portalsononucleacrellinfiltratem,ild Portalbileductproliferatiosni,ld -Yascularmineralizationm,inimal Perivasculamrnanuclearinfiltratem,ild -Not examined,not in plantof section -Adenoma -fteosiderosism,oderate The folIDNingtissues*ere foundto be withinnormallimits: Uterus,Ovary,Ramry Gland,Stomach,UrinaryBladder,Thyroid,Trachei,Esophagus, SalivaryBlind,Pancreas,Heart,Kidnty. Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 264 455 Buseari?edSingleTabulatedAnimalReport(continued) IndividuaMlacroscopiacnd MicroscopiMcservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year OralToxicity-OncogeniciSttyudy in Rats Table:2 AnimalNumber: IN-4894 Six:Female Broup: 4) FN-392410 ppe Fate: (Weeks105)TerminalSacrifice MacroscopicObservations: Mammary Gland MicroscopicObservations: Li.ver Lung Pancreas Parathyroid Pituitary Thyroid Uterus -Circulanrodule,14 .5 ce dia.,milkcystwhich ruptureduponincision. -kpatocytovacuolationo,ultifocalm,ild -Yasculimrineralizatims,ild -Acinaratrophy,moderate -Notexamined,not in planeof section -Adenosa -Ultimcbranchicaylst -Cysticglands,mild The followintgissueswerefoundto be withinnormallimits: Spleen,Kidney,Heart,Ovary,HismaryBland,Stomach,UrinaryBladder,Adrenal,Trachea, Esophagus,SalivaryGland. ------- --------------------- -- ------------------AniailNumber:IR-4895 Sex:Female Group:1 4) Ffl-392140pps Fite:(Week=80)Sacrificeidn extresis Nacruscapi@Observations: MicroscopicObservations: Heart Liver Lung Pituitary -No visiblelesions. -Nyocarditisc,hronicnonsuppurative, oultifocimli,ld -Hepatocytveacuolationo,ultifocalm,ild Necrosis,focal,minimal -Hemorrhage,localareas,moderate -Adenosa Thefollowintgissueswerefoundto be withinnormallimits: Spleen,Kidney,Uterus,Ovary,MammaryGland,Stomach,UrinaryBladder,Adrenal,Thyroid, ParathyraidT,rachea,Esophagus,SalivaryBlind,Pancreas. - --- ------------------------ ----------------------- -- AnimalNumber:IR-4896 Set:Female Group:( 4) FM-392410 ppe Fate:(Week-1-05)TerminalSacrifice MacroscopicObservations: MisearyGland -Lobulamriss,4 1 3 1 2 ca,le4taxilla. Kidney -Pileandpitted. MicroscopicObservations: Adrenal -Corticavlicaclationl,ocalart&%,sild Sinusaidaelctisiac,ortei,aild ------------------------------------------------- Species:Rat ProjectNumber: 0281CROO12 SuimarizedSTAR Page: 265 456 SummarizSeidnglTeabulateAdnimaRleport(continued) IndividuMaalcroscopaincdMicroscopOibcservations RikerLaboratoriIensc,.3N FN-3924T:woYearOralToxicity-OncogenSitcuidtyiynRats Table:2 AniaalNumber: IR-48% Sex: Fisale Group: 4) FN-312410 pps Fit@: (Neekz105)TerminalSacrifice MicroscopicObservationslcontinued): Kidney Liver Lung HassiryGland Ovary Pancreas Pituitary Uterus -Chronicprogressivenephropathy,marked -Portalsononucleacrall infiltratem,inimal Portalbileductproliferationm,inimal Nepatocytealteration,basophilic4,ocal, mild -Alveolar"crophages,focal,minimal -Fibroidenoma -Cyst,unilateral Tubularhyperplasisb,ilateral,moderate -Polyarteritism,arked -Adenoma -Polyarteritimso,derate The followintgissueswerefoundto be withinnormallimits: Spleen,Heart,Stomach,UrinaryBladder,Parathyroid,Trachea,Esophagus,SalivarySland, Thyroid. ---------------- ------------------- -------------------- - ---------- Anisal Number: IR-4897 Sex: Feeale Group: 41 Ffl-392410 ppe Fate: (Week=105)TerminalSacrifice MacroscopicObservations.:, Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Ovary Pituitary -Softhemorrhagic&ass, 0.6 ce dia. -Sinusaidalactasia,cortex,marked -Chronicprogressivenephropathy,minimal Pelvicmineralizationm,inimal -Pwtalsononucleacrellinfiltrates,ild Repatocytoalterationb,asophilic,4ocal, minimal Repatocytevacualation,peripartal,moderate -Alveolar"crophages,4ocal,minimal Cyst Large cysticbronchuswith squamous metaplasioif epitheliumf;illedwith keratin. Vascularsineralizatmi, eiltd -Cyst,unilateral Tubularhyperplasiab,ilaterals,ild -Adenosa Thefollowintgissueswerefoundto be withinnor") limits: Spleen,HeArt,Uterus,HisearySland,Stomach,UrinaryBladder,Thyroid,Parathyroid,Trachea, ---- ----------- - -- ------------ Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 266 457 SummarizedSingleTabulatedAnimalReport lcantinved) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FK-3924:Too Year OralToxicity-OncoginiciSttyudyin Rats Table:2 AnimalNumber: IR-4897 Sex: Female Group: 4) FN-3924 10 ppe Fate: fneekz105)TerminalSacrifice MicroscopiOcbservations(continued): Thefollowingtissuesmorefoundto be withinnormallimits(continued): Esophagus,SalivaryBland,Pancreas,Brain. ----------- ---------------------------- Animal Number: IR-4099 Sex: Female Group: 4) W3924 10 ppe Fate: lkeekg 87) FoundDead MacroscopicObservations: Lang Uterus Pituitary MicroscopicObservations: Adrenal Heart Liver Lung ovary Pituitary Uterus -Appearedto be filledwithred fluid -Appearedenlarged,fluidfilledand @arkened. -Enlarged,0.0 1 0.6 ca. -Sinusoidalectasia,cortex,moderate Corticaldegenerationl,ocalareas,moderate -Myocarditisc,hronicnonsuppurative, @UltifKA1, minimal -Repatocytveicuolationo,ultifocalslild -Vascularmineralizationm,ild Edna, local areas,moderate -No diagnosis,inadequatesection -Adenooi -Cysticglands,marked Hydrosetra,marked The followingtissueswere foundto be withinnormallimits: Spleen,Kidney,MammarySland, Stomach,UrinaryBladder,Thyroid,ParithyrDid,Trachea, Esophagus,SalivaryBland,Pancreas. ---------------------------------------------------------------------------------- Animal Number: IR-4899 Set:Feeale Group: 4) FN-3924 10 ppe Fate: (Neeka 60) FoundDead MacroscopicObservations: Skin Kidney Uterus Pituitary MicroscopicObservations: Adrenal Esophagus Lung -Subcutaneoumsass,2.5 x 3 ca, left inguinal. -Cyst#0.5 1 0.3 ca,on exteriorof left kidney. -Appearedenlirged;rightFallopiantubedark. -Largehemorrhagicmass, 1.5 x I ca. -Not examined,missing -Not tiaminedgmissing -Vascularmineralizationm,ild Perivasculaornanucltarinfiltrates,ild Edetaglocal areas,moderate Species:Rat Project Number: 0281CRO12 @uwized STAR Pap: 267 458 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N Fff-3924T:wo Year Oral Toxicity-OncogeniciSttyudyin Rats - - -- --- ---- -- ----- --- Animal Number: IR-4899 Six: Female 6roup: 4) FN-392410 pps Fite: (Meek= 80) FoundDead Table:2 MicroscopicObservations(continued): Mammary Bland Parithyroid Pituitary Spleen Thyroid Trachea UriniryBladder -Lobularhyperpiisia Balactacele -Not examined,missing -Adenama -Hmsiderosis,mild -Not examined,missing -Not examined,missing -Not examined,missing The followingtissueswere foundto be withinnormallimits: Liver,Kidney,Heart,Uterus,Ovary,Stomach,SalivaryBland,Pancreas. -- --------------------- .Animal Number: IR-4900 Sex: Female Broup: 4) FN-392410 ppe Fate:(Week= 95)Sacrificedin extresis MacroscopicObservations: Spleen Liver Large Intestine -Enlarged -Slightlypale with roughsurface. -Mass,3.5 1 2.3 s 1.5 ce, protrudingfrom cecusat ileocicalvalvearea, possiblycausinga restrictioinn valvearea resultingin a grossenlargement LymphNode (sesentoric) SmallIntestine of theileus. -Slightlyenlarged, -Wallsthickenednear cecus. MicroscopicObservations: Adrenal Heart -Sinusaidaelctisia,cortex,moderate malignantlyaphola,histiocytic -Myocarditisc,hronicnonsuppurativef,K&I, minimal Kidney -Malignantlyaphosa,histiocytic Proteinresorptiondroplets,marked LargeIntestine -malignantlyaphoma,histiocytic massiveneoplasticinvolvement04 cecalmill Liver Long withulcerationof lusenalsurface. -Malignantlyaphosa,histiocytic -Yascularmineralizationa,inisal malignantlyaphoma,histiocytic Lymph Nods (mosenteric) -Malignantlyaphosa,histiocytic Haamary Bland -Not examined,missing Ovary -Malignantlyaphoea,histiocytic - ------------------------------------------- --- -- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 268 459 Sumarized SingleTabulatedAni"l Report(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboril,crieIsn,c. 3H Ffl-3924:Two Year Oral Toxicity-OncogenicityStudy in Rats -- - - - --- -- - ------------------------ --- ---- ---Animal Number: IR-4900 Sax: Female 6roup: 4) FN-3924 10 ppe Fate: (@eekz qS) Sacrificedin extrosis Table: 2 ?,-acroscopOibcservations(continued): Pancreas SmallIntestine Spleen Thyroid Urinary Bladder -Malignantlymphosi,histiocytic -malignantlymphona,histiocytic -Malignantlymphoma,histiocytic -Ultisobranchiaclyst -Malignantlymphata,histiocytic The followingtissueswere found to be withinnormallimits: Uterus,Stomach,Parathyroid,Trachea,Esophagus,Pituitary,Salivarygland. --------------------------------------------------------------------------------------- Animal Number: IR-4901 Sex: Female Group: 4) FN-3924 10 ppe Fate: (We'ekz56) Sacrificedin extresis Macroscopic Observations. Skin Microscopic Observations: Eye Kidney Liver Lung Mammary Bland Pancreas Spleen Uterus -Large sternal subcutaneousmass, measuring 10 x 9 1 5 ca. -Keratititc,hronic,unilateralm,ild -Pelvic @ireralizationm,inimal -Nesatopciesis,extrasedullary -Yasculirsintralizations,ild Pneumonia,interstitialc,hronic,oultifocal, moderate Perivascularsononuclearinfiltrate,moderate Huarrhage, oultifdcal,mild -Fibroadenosa Sternal mass. -Not examined, missing -Romatopoitsis,extramedullary,increased, moderate -Not examined,missing The followingtissueswere found to be withinnormallimits: Heart, Ovary, Stomach,UrinaryBladder, Adrenal,Thyroid,Parathyroid,Trachea,Esophagus, SalivaryBlind,Pituitary,Large Intestine. --- ------------- ----- -------- ------------------ ------- -- -- -- ---- ----------------- Species: Rat Project Number: 0261CRO12 Summarized STAR Page: 269 460 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two year Oral 7axicity-DocagenicitSytudy in Rats Table: 2 Anisal Number: IR-4902 Sex: Female Broup: 4) Fli-392410 ppe Fate: (Week= 101) Found Dead Macroscopic Observations: Pituitary MicroscopicObservations: Adrenal Kidney Liver Lung Pituitary Spleen -Hemorrhagicmass, 0.6 ca dia. -Sinusoidalectisia,cortex,sild Corticaldegeneration,local areas,mild -Pelvicmineralizationm,ild -Hepatacytevicuolation,oultifocal,mild -Vascularsintralizitionm,ild -Adencea -Hesosiderosis,mild The followingtissuesmere found to be withinnormallimits: Heart, Uterus,Ovary, MammaryGland, Stomach,Urinary Bladder,Thyroid,Parathyroid,Trachea, Esophagus,SalivaryBlind, Pancreas. ------------------- -- ---- - - ---------------- - -- -------------------- Animal Number: IR-4903 Sit: Female Broup: 4) FN-3924 10 ppe Fite: ikeekz105)TerminalSacrifice NacroscapicObservations: Pituitary Microscopic Observations: Adrenal Heart Kidney Liver Lung Pituitary -Soft hemorrhagicmass, 0.7 ce. -Sinusoidalactasia,cortex,marked -Nyocirditis,chronicnonsuppurativt, oultifecal,minimal -Pelvicmineralizationm,ild -Portalbile ductproliferationm,ild Nepitocytealterition,basophilic, local areas, moderate -Vascularmineralizationm,ild -Adenm The followingtissueswere found to be withinnormallimits: Spleen,Uterus,Ovary, MammarySlind, Stomach,Urinary Bladder,Thyroid,Pirathyroid,Trachea, Esophagus, Salivary Bland, Pancreas. ----------------------- ------- ---------------------------- ----------------------------- Animal Number: IR-4904 Set: Female 6roup: 1 4) FM-392410 ppe Fate: (Weekz 95) Found Dead Macroscopic Observations: Mammary Bland -multilobulamrass,5 x 2.5 x 1.2 ce, in right axilli.;mass, upper shoulder area a4 right 4orelimb,3 1 3.4 1 2.5 ca. Spleen -Enlarged -7- --------------- -------------------------------- Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 270 461 SummarizedSingleTabulatedAnimalReport (continuedt' IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogenicitSytudy in Rats Table: 2 Anisal Number: IR-4904 Sex: Feeale Group: 4) FN-3924 10 pps Fate: (Weeks 95) Found Dead MicroscopicObservations(continued): Liver (continued) MicroscopicObservations: Adrenal Kidney Liver Lung Raosiry Blind Parathyroid SalivaryBlind Spleen -Pale -Sinusoidalectasia,cortex,mild -Pelvicmineralizationm,ild -Hepitocytovacuclation,contrilobular, moderate Necrosis,centrilabularm,ild -Vascularmineralizations,ild -Adenocarcinoma Adenocircinoma -Not examined,not in plane of section -Not examined,missing -Netitapoitsise,xtramedullary,increased, marked The followingtissueswere found to be within normallimits: Heart, Uterus,Ovary.,Stosach,_Uriiiary_lladdeTrh,r-oid,.TricheaE,sophagus,Pituitary,Pancreas. -------------------------- ------ --- Animil Number: IR-4qO5 Sex: Female Group: 4) FM-3724 10 ppo Fate: (Weekr105) TerminalSicrifice Macroscopic Observations: Microscopic Observations: Adrenal Heart Liver Lung Uterus -No visiblelesions. -Sinusaidalectisia,cortex,moderate -Myocarditis,chronicnonsuppurative, oultifocal,minimal -Portalacnanucltacrell infiltrates,ild Portalbile duct proliferationm,ild -Pneumonia,interstitialc,hronic,oultifocil, sild -Hydrometra, marked Polyp The followingtissueswre foundto be withinnormallimits: Spleen,Kidney,Ovary, MammarySland, Stomach, UrinaryBladder,Thyroid, Pirathyraid,Trachea, Esophagus,SalivaryGland, Pituitary,Pancreas. Species: Rat Project Number: 0281CROO12 Summarized STAR Page: 271 462 Suowized SingleTabulatedAnimalReporticantinued) IndividualNacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two Year OralToxicity-OncogenicitSytudyin Rits --- --- --- Animal Number: 12-4906 Sex: Female Group: 4) FN-392410 pps Fate: (Weeks75) Sacrificedin extresis Table:2 MacroscopicObservations: Pituitary HasairyBland MicroscopicObservations: Adrenal Kidney Lung NamaiirySland Pituitary spleen -Raisedred mass,1.2 x 0.0 ca. -Nodularcysticmass,2 1 0.5ce, in right inguinalarea. -Sinusaidilectasiiic,ortex,moderate -Chronicprogressivenephropathy,minimal -Pneumoniai,nterstitialc,hronic,oultifocal, sild Hemorrhage,local areas,mild -Lobularhyperplasia -Adenoma -Hemsiderosislmoderate The followingtissueswere foundto be withinnormallimits: Liver,Heart,Uterus,Ovary,Stomach,UrinaryBladder,Thyroid,Parathyroid,TrachealEsophagus, SalivaryBlind,Pancreas,Skin. ------------------------ - - - --------- Animal Number: IR-4907 Sex: Fesile Group: 4) FN-3924 @10ppe Fite: lneekx105)TerminalSacrifice MicroscopicObservations: Pituitary Mammary Sland MicroscopicObservations: Adrenal Kidney Liver Lung Haseary Bland Pituitary Uterus -Softhemorrhagicmass, I ce dia. -Dark&ass,4 1 4 1 3.5 ce, in perinealarea.; lobuliimrass,5 1 4 1 3 ca,in leftinguinalarea. -Sinusoidalectisia,cortex,marked -Chronicprogressivenephropathy,mild -Portalsononucleacrellinfiltrates,ild Portalbileductproliferationm,ild -Vascularsineralizatiosni,ld Pneumonia,interstitialc,hronic,oultifocal, sild Alveolarmacrophageso,ulti4ocal,mild -Fibroadenosa Adenocarcinasa -Adenosa -Cysticglands,marked The followingtissueswerefoundto be withinnormallimits: Spleen,Heart,Ovary,Stomach,UrinaryBladder,Thyroid,PirathyraidT,rachea,Eomhafvsl SalivarySland,Pancreas. -- -- - ---- --------------------------------- Species:Rat Project Number: 0281CRO12 Sourized STAR Page:272 463 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N Ffl-3924T;wo Year Oral Toxicity-OncogenicitSytudy in Rits - ------ ----Animal Number: IR-4908 Sex: Female Group: Fate: (Meek= 67) Sacrificedin extresis 4) FN-3924 10 ppe Table: 2 Microscopic Observations: Pituitary Mammary Gland Adrenal Microscopic Observations: Adrenal Kidney Lung Massary Gland Parathyroid Pituitary Spleen -Large hemorrhagicmass, 1.2 ce dia. -Cysticeassaryglandsfilledwith whitefluid in perinealand rightaxillary areas. -Right adrenalenlarged. -Sinusoidalectasia,cortex,marked -Chronic progressivenephropathy,minimal Pelvic mineralization,marked Hyperplasia,pelvicepithelium,mild -Hemorrhage,local areas,moderate -Balactocale SaIACtKIle -Not examined,not in plantof section -Adenou -Hmsideresis, moderate The followingtissuessere found to be withinnormal limits: Liver, Heart, Uttrus,Ovary, Stomach,Uriniry Bladder,Thyroid,TrachealEsophagus, SalivaryGland, Pancreas. ------------------------------------------------ --- - Animal Number: IR-4909 Six: Female Group: 4) FN-3924 10 ppe Fate: (Meek-1-03) Sacrificedin extresis Macroscopic Observations: Stomach -Multiplefocalareasof ulceration. Pituitary Rimeary Gland -Hnorrhagic mass,0.7 ce dia. -Subcutaneous&ass, 2.5 x 2 ce, in right axilla. Thorax(internal) -Filledwith fluid. Lung Liver -Hewrrhigit,all lobes. -Palo,sottled,with scatteredyellowishfoci and an irregularsurface. Kidney -Pale and pitted. Microscopic Observations: Adrenal -Corticalvacuolition,local areas,mild Sinusoidalectisia,cortex,moderate Malignantlyaphosa,histiocytic Kidney -Chronicprogressivenephropathy,mild Pelvicmineralizations,ild MalignantIY@PBM, hi$tiKytiC Proteinresorptiondroplets,urked ---------------------- ------- ----------------------------- Species: Rat Project Number: 0201CROO12 Sunw iztd STAR Page: 273 464 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicMservations RikerLaboratoriesI,nc. 3N FN-3924:Too Year OralToxicity-OncoleniciSttyudyin Rats Table:2 Animal Number: IR-4909 Sex: Female Group: 4) FN-392410 ppe Fate:(Vtekz103)Sacrificedin extresis MicroscopicObservationslcontinued): Liver Lung has ary Gland Pan:reas Parathyroid Pituitary Spleen Stomach UrinaryBladder Uterus -*alignantlymphoma,histiocytic -Vascularmineralizations,ild Malignantlyaphosa,histiocytic hemorrhage,diffuse,marked 4ibroadiinoom Malignantlyaphou, histiocytic -Malignantlyaphoma,histiocytic -Notexamined,not in plantof section -No diagnosis,inadequatesection -Malignantlyaphosa,histiocytic -Malignantlyaphosa,histiocytic -Malignantlyaphoma,histiocytic -Cysticglands,marked The followingtissuesmore foundto be withinnormallimits: Heart, Ovary,Thyroid,Trachea,Esophagus,SalivaryBland. ------------------ --- ---- - ---- - -- -- Animal Number: IR-4qlO Sex: Female Sroup: 4) W3924 10 pps Fate:(Weekz 85)Sacrificedin extresis MacroscopicObservations: Pituitary Haseary Gland MicroscopicObservations: Kidney Liver Lung Pituitary Spleen -Hemorrhagicmass,I 1 0.5 ca. 4ilk cystin perineilarea. -Yacualationc,onv.tub. epitheius,mild Pigment,conv.tub.epithelium,brown,sild -Portalsonanucleacrellinfiltrates,ild Portalbileductproliferatiosni,ld Hepatacytevicuolationc,ontrilobularm,ild Nepatocytaelterationb,asophilico,ultifocal, sild -Vascularsineralizationm,ild Alveolarmacrophages,sild -Adenosa -Hetasidernsism,oderate The followingtissueswerefound to be withinnormallimits: Heart,Uterus,Ovary,KamearyBland,Stomach,UrinaryBladder,Adrenal,Thyroid,Parathyroid, Trachea,Esophagus,SalivaryBland,Pancreas. -- ---- --------------- ------------------------- ------ -- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 274 465 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopiOcbservations RikerLaboratoriesI,nc. 3N Ffi-3924T:wo Year Oral Toxicity-OncolenicitSytudy in Rats Table:2 Animal Number: IR-4911 Six: Feeale Group: 4) FN-3924 10 ppe Fate: (Veekr.97) Sacrificedin extrnis Macroscopic Observatims: Adrenal Pituitary Mammary Gland MicroscopicObservations: Adrenal ClitoralGland Heart Kidney Liver Lung Mammary Gland Ovary Pituitary -Enlarged -Possiblyslightlyenlarged. -Subcutaneousoultilobularmass, 8.5 x 5.5 1 4.5 re, right axillaisubcutaneous oultilobulacrysticmass,5 1 4.5 x 2 ca, in leftilxillts;ubcutaneoucsystic, oultilDbuliLmrass, 6 x 7 1 3 co, in throat area,filledwithtan coloredfluid -Sinusaidaltctasia,cortex, marked -Cyst -Kyocarditis,chronicnonsuppurative, oultifkal,mild -Pelvicmintralizittiomni,nimal Wephrosis,tubular, moderate -Hepatocytoalteration,basophilic,oultifocal, sild -Vascularaintralizatim,sild-: Pneumonia,interstitial,chronic,oulti4ocal, sild Alveolarmacrophages,oultifocal,mild Perivascul&rsononuclearinfiltrate,mild Granuloma,oultifocal,mild -Fibroadenoma Balactoctle Fibroadenm Adenocartincea Tumor &risingin area of lobularhyperplisia. -Cyst, unilateral -Adenoei The followingtissuesmere found to be withinnormallimits: Spleen,Uterus,Stomach,Urinary Bladder,Thyroid,Parathyroid,Trachea,Esophagus, SalivaryGland, Pancreas. ------------------------ -- --- --- ---------- - --- ------------- ------ Species:Rat Project Number: 0291CROO12 Summarized STU Page: 275 466 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Too YearOral Toxicity-WcogenicitSytudy in Rats Table:2 AnimalNaber: IR-4912 Six:Fesile Group: 4) FN-3924 10 ppe Fate:(Nuka 09)Sacrificeidn extresis MicroscopicObservatmis: Pituitary MicroscopicObservations: Kidney Liver Lung Ovary Pituitary Spleen -Hemorrhagicmass, I cs dia. -Chronicprogressivenephropathy,minimal Pelvicmineralizationm,inimal Pyelitis,acute,mild -*itdcyto vacoolationd,iffuse,moderate -Vascularmineralizationm,ild Perivasculasrononucleairnfiltratem,ild htelectasisl,ocalareas,sild Hemorrhage,oultifocalm,ild -Tubularhyperplasiab,ilateral,moderate -Adenosa -Hemosiderosis,marked The followingtissueswere foundto be withinnormallimits: Heart,Uterus,ManeiryBland,Stomach,UrinaryBladder,Adrenal,Thyroid,Parithyroid,Trachea, Esophagus,SalivaryGland, Pancreas. ------------------- ---- ---- ------ - - -- --- -- --- ------------- AniaalNuebtr:IR-4913 Sex: Female Group: 4) W3924 10 ppe Fate:(Weeka99) Sacrificedin extresis MicroscopicObservations: Pituitary Nassary Gland MicroscopicObservations: Adrenal Kidney Liver Lung Mammary Gland Pituitary SalivaryBlind Stomach Thyroid -Hemorrhagicmass, 1.2cc dia. -Lobulatemdass,3 cc dia.,rightinguinal. -Sinusoidaelctasia,cortex,sild -Chronicprogressivenephropithys,ild HyperplasiaP,elvicepitheliumo,ultifocal, aild -Portalsononucleacrellinfiltratem,ild Portilbileductproliferatiomni,ld Hepatocytevicuolationo,ultifocalm,ild -Vascularsineralizationm,ild Alveolareacrophageso,ultifocal,mild -Fibraidenoma -Adencea -Not examined,missing -Bastritisa,cute -C cell adenona The followingtissueswere foundto be withinnormallimits: Spleen,Heart,Uterus,Ovary,UriniryBladder,Parathyroid,Trachea,EsophikgusPlancreas. ------------ -- ------------------------------------- -- Species:Rat Project Number: 0281CROO12 Summarized STAR Page: 276 467 SummarizedSingleTabulatedAnisalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3H FN-3924:Two Year oral Toxicity-OncoginicitSytudy in Rats --------------------- ----- --- - Animal Number: IR-4914 Sex: Fesile Group: Fate: (Week=105) TerminalSacrifice 4) FN-3924 10 ppe Table: 2 Macroscopic Observations: Pituitary Mammary Gland MicroscopicObservations: Adrenal Heart Kidney Liver Lung Mammary Gland Pituitary Uterus -Hemorrhagicmass, 0.4 co dia. -Largefire mass,9 1 6 x 4 ce, left axilla; smallcysticmass, 2 ce dia., in left inguinalart&. -Sinusaidalectasia,cortex,mild -Nyocarditis,chronicnonsuppurative,focal, sild -Chronic progressivenophropathy,minimal Pelvicmineralizations,ild -Hepatocytovicuolation,sultifocal,aild Hepatocytoalteration,basophilic,focal, minimal -Yascularmineralizationgminimal Alveolarmacrophiges,AUltifKal# sild Perivascularsononuclearinfiltrate,minimal -Fibroadenoai Adenocar,cinoma,pa,Pi-ll.ary." -Adences -Cysticglands,mild The followingtissueswere found to be withinnormallimits: Spleen,Ovary, Stomach,UrinaryBladder,Thyroid, Parathyroid,Trachea,Esophagus, Salivary Gland, Pancreas. ---------------------------------------------- - ----------- ---- Anisal Number: IR-4915 So%: Fesale Group: 4) FN-3924 10 ppe Fate: (Week= 82) Found Dead MacroscopicObservations: Kidney Liver Microscopic Observations: Adrenal Esophagus Liver Lung Ovary Pancreas ---------------- --- ------- ---- ------ -Mottled -Pale -Pheochronacytosaobenign One of pair present -Not examined,missing -Nepatocytovacuolation,diffuse, marked -Yascularmineralizations,ild Alveolarmacrophages,oultifocal,mild -Withinnormal limits One of pair present -Not examined,missing Species: Rat Project Number: 0291CROO12 Summarized STAR Page: 277 468 SummarizedSingleTabulatedAnimalReport (continued) IndividualNacroseopicand NicroscopitObservations RikerLaboratoriesI,nc. 3H FIF3q24:Two YearOral Toxicity-OncogeniciSttyudyin Rats - --- - ------------- ----Animal Number: IR-4915 Six: Female Group: 4) FN-392410 ppe Fate: (Neeks 62) FoundDead Table:2 MicroscopicObservations(continued): Pirathyroid Pituitary SalivaryGland Thyroid Trachea UrinaryBladder -Not examined, missing -Not examined, missing -Not examined, missing -Not examined, missing -Not examined, missing -Not examined, missing The followingtissuessere foundto be withinnormallimits: Spleen,Kidney,Heart,Uterus,Naa@iLrBylind,Stomach,Eye. --- -- ------------------ AnimalNumber: IR-4916 Sex: Female Group: 4) FN-392410 pps Fate: (Meek=105) TerminalSacrifice MacroscopicObservations: Mammary Bland Adrenal MicroscopicObservations: Adrenal Kidney Liver Lung Mammary Gland ParathyrDid Spleen Thyroid -Multilobulasrit&,13.51 6 % 4.5 ce,right axillaand lateralarea. -Leftadrenalenlargeddue to mass, 1.7 ca dia. -Sinusoidalactasia,cortex,marked Enlargementof left glanddue to massive sinusaidalectasia. -Pelvicmineralizationm,inimal -Nepatocytaelterationv,icuolitedf,ocal, aild -Alveolarmacrophagtso,ultifocal,mild Pneumonia,interstitialc,hronic,oulti4ocal, sild -Fibroadenosa -Not examined,not in planeof section -Nesatopoiesise,xtramedullaryi,ncreased, minimal -Ultimobranchiiclyst The followingtissuesare foundto be with4anormallimits: Heart,Uterus,Ovary, Stomach,UrinaryBladder,Trachea,Esophagus,SalivaryBlind,Pituitary, Pancreis. - - ------------ - ---------------------------------------------- Species:Rat Project Number: 0261CROO12 5m arizedSTAR Page:278 469 Sumarized SingleTabulatedAnimalReport(continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3K FN-3q24:Tva Year Oral Toxicitrancovenicitsytudyin Rats Animal Number: IR-4917 Six:Female Group: 4) FN-392410 ppe Fate: (Meek=105)TerminalSacrifice Table:2 NacroscapicObservations: Pituitary MicroscopicObservations: Adrenal Kidney Lung Ovary Pituitary -Raisedmass,0.9 ce dia. -Sinusaidalactisia,cortex,moderate -Pelvicmineralizatiosni,ld Calculus,pelvic,moderate -Vascularmineralizations,ild Pneumoniai,nterstitialc,hronic,sultifocal, sild Perivasculasrononucleairnfiltratem,ild -Tubularhyperplasiab,ilateral,sild -Adenesi The follaningtissuesverefoundto be mithinnormallimits: Spleen,Liver,Heart,Uterus,Hismarygland,Stomach,UrinaryBladder,Thyroid,Parathyroid, Trachea,Esophagus,SalivarySland,Pancrois,Eye. --- ----------------------------------- --- -- ------------- - -- --- -------------------- Animal Number: IR-4918 Set: Feeale Group: 1 4) FN-3q2410 ppe Fite: (Weeks105)TerminalSacrifice MicroscopicObservations., Pituitiry Liver Stomach Uterus MicroscopicObservations: Adrenal Esophagus Kidney Liver Lung Pancreas Pituitary Spleen Stomach ------------- -Kass,1.0 ce dia. -Palo -Raisedmass,1.3 x I ca. -Largefirecervicalmass,3.5 1 3.5 ce. -Sinusoidaelctisis,cortex,sild Corticaldegenerationl,ocalareas, moderate -Not exaained,missing -Chronicprogressivenephropithya,ild -Portalsonmucltarcellinfiltrates,ild Portalbileductproliferatiosni,ld Nepatocytovacuolationd,iffuse,sild -Vascularsineralizamt,i sild Hemorrhage,local areas,moderate -Not examined,missing -Adenoma -Nnitapoiesis,extrasedullaryi,ncreased, sild -Ulcer,diffuse,sarklkd Bross appearanceof a &ass dus to extensive ulcerationuith edemaof subsucm. Species:Rat ProjectNumber:ONICW12 Summarized STAR Page: 279 470 SummarizedSingleTabulatedAnimalReport (continued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3N FN-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats Table:2 AnimalNumber: IR-4910 Sex: Female Group: 4) FN-3?2410 ppi Fate: (Weekz105)TerminalSacrifice MicroscopicObservations(continued): Uterus -Netritisa,cute,sild Leiosyoma Mass fromcervix;extensivenecrosis. The folloning'tissuweesre foundto be withinnormallimits: Heart,Ovary,Mammary61and,UrinaryBladder,Thyroid,PiirathyroidT,rachea,SalivaryBland,Eye. --- ------------------------------- --- -- AnimalNumber: IR-4919 Sex: Fesile Group: 4) FN-3924 10 ppe Fate: (Veekz105)TerminalSacrifice MacroscopicObservations: Thyroid Pituitary Adrenal MicroscopicObservations: Adrenal Kidney Liver Lung Ovary Pituitary Thyroid -One appearsenlarged. -Softhemorrhagicmass,0.6 cm dia. -Right adrenalenlarged. -Sinusaidaalctisia,cortex,unilateral, marked Corticaldegenerationu,nilateralm,arked Adenoma,unilateral Extensivesinusoidalectasiaand degeneration in non-neoplastigcland. -Chronicprogressivenophropathy,sild Pelvicmineralizationm,ild -HipatKyteV&CUOlitiOn@,UltifKil,sild -Yascularmineralizations,ild Metastaticneoplasm -Tubularhyperplasiab,ilateral.m,oderate -Adenota -C cell carcinoma Infiltrativwee,lldifferentiatesdo;litary metastasiri,n lung. The followingtissues*ere found'%.bae withinnormallimits: Spleen,Heart, Uterus,Mammary 61and, Stomach,UrinaryBladder,Parathyraid,Trachea,Esophagus, Salivary61&nd, Pancreas. ------------------- ------------------------------------------------- - ---------- Species:Rat ProjectNumber: OnICRO12 Summarized STAR Page: 2M 471 SummarizedSingleTabulatedAnimalReport lcontinued) IndividualMacroscopicand MicroscopicObservations RikerLaboratoriesI,nc. 3M FN-3924:Two Year OralToxicity-NcolenicSittuydyin Rats Table:2 Animal Number: JR-4920 Sex:Feeale group: 4) FN-392410 ppe Fate:(Neekz 60)FoundDead MicroscopicObservations: Liver Skin MicroscopicObservations: Adrenal Kidney Liver Lung Mammary Gland Pituitary Skin Spleen Thyroid -Pale,scatteredwhitenoduleson all lobes, 0.1- I cedia. -Subcutaneou&sassbehindleftshoulder,6 ca dia.by 2 ce thickwith3 ce dia. ulceratedarea. -Hematopciesitsi,triotdullarmyi,nimal -Proteinresorptiondroplets,marked -malignanltyspholah,istiocytic -Vasculasrintralizatiosni,ld -Notexaminedlmissing -Adonama -malignanltysphonah,istiocytic -Hematopoitsiesx,trisedullaryi,ncreased, mild -Ultiacbrinchciytslt The followintgissueswerefoundto be withinnormallimits: Heart,Uterus,Ovary,Stomach,UrinaryBladder,ParathyroidT,rachea,Esophagus,SalivaryBland, P-a-n-c-re-a-s-.-------------------------------------------- ------------------- Species:Rat ProjectNumber: 0281CW 12 Sumerized STAN Page:261 472 Tissue Inventory Table:3 RikerLaboratoriesI,nc. 3H FN-3924:TiooYearOral Toxicity4ncogenicitSytudy in Rats- one Year Interim Project Number: 0261CROO12 Species:Rat Dose Group Name: CONTROL 0 ppe Tissue Name Animal Numbers Sex RRRRRRARRRRRRRRRRRRRRRRRR ------------------------- 333333333333334444444444 5555555555535555555556666 1 1 2 2 2 3 4 4 5 5 5 6 7 7 8 7 8 9 8 6 10 0 1 2 670 275 360 19805 0625 99 0 160 0 N IN N N N N N N N N N N N N F F F F F F F F F F Adrenal Aorta +4+ 4 .. ... ... ... .. .................4 ... ... . Done Marrom + 4 ............c .......... Brain .. . . . . . . . . . . . . . . . . . . . . . . . . Esophagus Eye .. ... ... .... ...4 + 4 .... ... + 4 .. .. .. ... 4 .. .... .. ... .. Heart .. ... ... .4 + 4 + 4 + 4 .. ... + + + Kidney ...4 + 4 .........+ . Large Intestine Liver Lung Lymph Node (sesenteric) .. .... .. .... ...4 c + + + . + 4 + + + + + 4 ................. ...........4 + 4 + 4 .. .... ... C + C 4 + 4 . 4 + + + 4 + C ......C + + Rateary Gland Ovary Pancreas + + - 4 - --- ---- ---- -4 .... ... ......................... ......................... Parathyraid c c c c + c .....c c + c c c c + c . ..c + Pituitary + + c ... .. ..... ... ... 4 .. . Prostate ......................... SalivaryGland .. .... .... ... ... ... Small Intestine .................* ... ... . Spinal Card ..............c . ..c 4 + + + + + Spleen .............4 ........... Stomach Testis/Epididysis Thyroid .. ... ..C . ... ...4 .. ..... .. ......................... c c + c + c ...............4 . Trachea .......* . + + 4 . 4 ....... UrinaryBladder ......... + + + + + + c .......c Uterus ......................... hesentary Skin Ureter The follovintgissue(sw)re not requiredby protocol---------------------------------------- ------------------------- ------------------------- A + indicatesthat a diagnosiswas "do. A - indicatesthat no diagnosisor commentwas made. 473 A c indicatesonly a nondiagnosticomment*as made. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage:M TissueInventory(continued) Table:3 RikerLaboratoriesI,nc. 3H FA-3924:Two Year Oral Toxicity-OncogenicitSytudyin Rats - One Year Interim Project Number: 0281CROO12 Species:Rat Tissue Name Dose Group Name: CONTROL 0 pps I II II RRRRR Animal Numbers - - - - 4 44 44 66666 2 3334 90 1 2 0 Sex F F F F F Adrenal Aorta Bone Narrow Brain Esophagus Eye ..... C4. ..... ..... ...* + ...+ + Heart Kidney Large Intestine Liver ..... ..... ..... ..... Lung Lyaph Node (sesenteric) Mativary61and + +c++ ..... Ovary Pancreas + 4 . .. ..... Parathyraid Pituitary Prostate Salivarygland Small Intestine Spinal Cord Spleen ccc + c ..... ----- ..... ++ ++ + ..... ..... Stomach Testis/Epididysis ----- Thyroid +C +++ Trachea +4+4+ UrinaryBladder ++ c++ Uterus ..... ---------------T-h-e-f-ollowingtissue's@were not requiredby protocol------------------- Nesentiry ----- Skin Ureter +-------- A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentwas Bade. A c indicatesonly a nondiagnosticommentwas made. Pleaserefer to the Single TabulatedAnimalReport. Tissue !nventoryPage:283 474 TissueInventory(continued) Table:3 RikerLaboratoriesI,nc. 3H FN-3924:Tno'Year oral Toxicity-OncoginiciSttyudyin Rats - One Year Interim Project Number: 0281CROO12 Species:Rat Dose Group Nast: FN-3924 100 ppe Tissue Name Animal Numbers Sex RRRRRRRRRRRRRRRRRRRARRRRR ------------------------3333333333333334444444444 6677777777777777777777777 9911122223333445666778888 6914501272367787013590235 NN 0NNN NNN ANN NNNF FFF FFF FFF Adrenal ... .... .. .. ... ... ... .... . Aorta Bone Marrou + 4 + 4 + 4 + 4 ... ... ... ... + *. 4 + 4 + 4 ...4 + 4 + + ... ... . Brain . .. . . . * . . . . . . . . . * 4 + 4 + + + + + Esophagus Eye Heart Kidney Large Intestine + # . .. 4 ... .. .... ... .. ..C . ... ...4 ... + ........... + 4 . ... .... ... 4 .. ... ... ... ...............* .. ... .... + + C ... ...4 + 4 + 4 .. .... ... + Liver .. ... .... .4 . . ++ Lung Lymph Node (sesenteric) + 4 + 4 + 4 . .... * .. .. .... ... .. .. ... ... .+ c ........4 C . ... Rassary Gland Ovary Pancreas Parathyraid Pituitary Prostate - - - - - - - - - 4. . . . . . . . . . 4 + + + + + -- ---- --- --- ---- --C ...... + 4 .. c ....4 ............. cc+ c+c c+c c+c+ ccc +ccc +c +c c . ... c c .. .... .4 + 4 .. .. .... . ... 4 .. ... ... .... ... ... ... SalivaryGland SmallIntestine Spinal Cord Spleen Stomach .... C ... ..E ... ... .... .... ...................4 .. . ............C ......4 + 4 . ......................... c ... .4 .. ... ..4 .... ... .... Testis/Epididysis + 4 + 4 .. ... ... .... ... ... ... Thyroid + C + C + + ++ + C + + + 4 + + . + + c + 4 + Trachea UrinaryBladder Uterus ......................... + C ..... c ....... ......................... ----------------The 4ollovingtissue(s)were not requiredby protocol------------------ Nesentary Skin -- ---- -- ---- -- -- -- --- ------ --- ---- ---- -- ---- -- -- - Ureter ------------------------- A * indicatesthat a diagnosismas made. A - indicatesthat no diagnosisor commentwas side. 475 A c indicatesonly a nondiagnosticcomment*as *ad*. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage:284 TissueInventory(continued) Table:3 RikerLaboratoriesI,nc. 3H FM-3924:Two YearOral Toxicity-OncogeniciSttyudyin Rats- One Year Interim Project Number: 0281CROO12 Species:Rat Tissue Name Dose Group Name: FM-3924 100 ppe IIII I R RRRR Animal Numbers - - - - 44444 777 66 88901 78366 Sex F F F F F Adrenal Aorta BDre Narrow Brain Esophagus Eye Heart Kidney .... ..... ..... ...4 + +cc ++ ..... + *. ..... Large Intestine Liver Lung Lymph Node (seseiftetic) Mammary Gland Ovary Pancreas +4 ..... +4+ + ..... ..... ..... t++ 4 + Parathyraid +c ccc Pituitary Prostate SalivaryGland SmallIntestine Spinal Card Spleen ----++c++ ..... ..... ..... Stomach Testis/Epididysis Thyroid Trachea ...4 + ----- + c ... + C ... UrinaryBladder Uterus ... + +4 + + ----------------T-h-e-f-ollowintgissue(s)were not requiredby protocol------------------- Nesentiry Skin -- +- ----- Ureter ----- A + indicatesthat a diagnosis*as made. A - indicatesthat no diagnosisor commentwas Bade. A c indicatesonly a nondiignosticommentwas made. Pleasere4orto the SingleTabulatedAnimalReport. Tissue InventoryPage: 285 476 Tissue Inventory RikerLaboratoriesI,nc. 3H FN-3924:TitoYear OralToxicity-OntogeniciSttyudyin Rats Project Number: 0201CROO12 Species:Rat Table:4 Dose Group Nate: CONTROL 0 ppe Tissue Rate Animal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------3333333333333333333333333 555555555555555555555555 1 122 222 223 3333 333 344 444 44 891345609012346789012457B N N N "n N n N N N N N N N N N N N N "N N N Adrenal Aorta BaneNarrow ......................... .. .... ...4 + 4 + + ........... . ..4 + 4 .. ...4 + 4 + + + + C 4 Brain Esophagus Eye Heart Kidney Large Intestine .. .... 4 + 4 ... ... .... .. + C .. ... 4 ... ... ..+ ... .. .. . .........4 + + c 4 + c ......c + + + 4 . ... . + + ......... .......... ......................... Liver . ...4 ... .... .. ...4 ... ... . Lung Lymph Node (sesenteric) Mammary Gland Ovary Pancreas Parathyroid ... .... .. .... .. ... ....c ..........c + 4 ....... --- --- --- ----- --- --- -- -- - ------------------------- ... .... .. ..... .C .... .. .. . c + c + c c + + c ... .c + c c c . ..c + 4 c Pituitary Prostate ......................... ........c .........c c .. .+ + SalivaryGland SmallIntestine Spinal Card Spleen Stomach + 4 . . . . . . C . . . . . . . . . . . . . .. . + + 4 ................+ .. . .......4 ..........C + + 4 + + + .............4 ........... .. .... .. .... .* .. ... ... .. . Testis/Epididysis Thyroid Trachea ...4 . 4 ... ..4 + 4 .. .c . .... c . .. .. .. .... .c + c + 4 + + c + + 4 + + * ... + + 4 ......... UrinaryBladder Uterus + + + 4 + 4 + 4 ... + 4 + 4 + + C C .. ... --- ---- -- -- -- ---- --- ---- - ---------------T-h-e-followintgissue(sw)ere not requiredby protocol------------------- Bone --- --- --- ---- ---- --- -- -- - ClitaralGland ------------------------- HarderianBland ------------------------- Lymph Node ------------------------- Lymph Node (abdominal) ------------------------- Lymph Node (thoracic) ------------------------- Resentary ------------------------- A + indicatesthata diagnosiswas made. A - indicatesthatno diagnosisor commentwas made. 477 A c indicatesonly a nondiagnosticommentwas side. Pleasereferto the SingleTabulatedAnimalReport. Tissue InventoryPage: 286 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Tissue Name Preputial 61and Skin Soft Tissues (abdomen) So4t Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifieTdissue Seneral Comment Dose 6roup Name: CONTROL 0 ppe Aniaal Numbers Sex RRRRRRRRRRRRRRBRRRRRRRRRR ------------------------- 333333333333333333333333 555555555555555555555555 1 122 22 2223 3333 333 344 444 44 8 9134 569 90 12 34 6789 012 4576 M N NhNM NNNN NNNN NNN NNN NNN NN ------------------------......................... ------------------------------------------------------------------------------------------------------------------------- ------------------------------------------------------------------------- A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentvis made. 478 A c indicatesonly a nondiagnosticomment*is made. Pleasereferto the SingleTabulatedAnigalReport. TissueInventoryPage: 287 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FN-3724:Two Year Bril Toxicity-OncogeniciSttyudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose Group Name: CONTROL 0 ppo Tissue Name Animal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------3333333333333333333333333 5555555555555555555555555 4555555566666666677777777 9234 5678 0 12 345 677 1234 679 9 "N N N n N N N n N N A "N n N N N n "N Adrenal + 4 + 4 + + + 4 + 4 + c + 4 .. .. .... . Aarta Bone Narrow . .... ...4 + + + + c ........... ..... c + + c + + + + * ....... Brain .....................* . Esophagus Eye + 4 + 4 + 4 + 4 .. ...C .. ... ..4 . + + C ..........C + + + 4 . 4 . Heart ... 4 ............... Kidney .........4 ... Large Intestine + + C .. .... 4 + + 4 C ........... Liver ...........4 + 4 .... ... ..4 + Lung Lymph Node (sesenteric) Mammary Blind Ovary Pancreas .. ...+ .............4 . 4 + + + c ..........c .... ..c + + 4 + ------------------------------------------------+ + c + + 4 ......c c .. ..4 ...... Parathyroid cc+ccc+c+cc +ccc++cccc c++ c Pituitary .....4 ... 4 + C ...c + + + + + 4 + Prostate . .... ... . C .... ... 4 . SalivaryGland + + c .......c + c c ......c + + + Small Intestine + + C ..........C + * ......... Spinal Card .........c + + c 4 + 4 ....... + Spleen .............4 . 4 . + . Stomach Testis/Epididysis ................ + c .........4 . + ........... Thyroid c ........C + 4 + C + + + + + Trachea' ...........4 + C .......+ . UrinaryBladder Uterus + 4 ...........C + 4 + 4 + + + C ... ------------------------- ---------------T-h-e-followintgissle's)werenot requiredby protocol------------------- Bone ClitaralGland HarderianGland Lymph Node I.yophNode (abdominal) Lymph Node (thoracic) Nesentary --------------------------- ---- ---- -- -- -- --- ---- -- --- --- ---- ---- --- ---- --------------------------------------------------------------------------- - - - - - - - - - - - - - - - 4 ---- --- A + indicatesthata diagnosis*as made. A - indicatesthatno diagnosisor coment Nis side. 479 A c indicatesonly a nondiagnosticommentwas made. Pleasereferto the SingleTabulatedAnimalReport. Tissue InventoryPage: 260 TissueInventory(continued) Riker Laboratories,Inc. 3H FN-3?24: Tva Year oral Toxicity-OncogenicitSytudy in Rats Project Number: 02BICROO12 Species: Rat Table: 4 Tissue Name Preputial Gland Skin Soft Tissues (abdomen) Soft Tissues(head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose Group Name: CONTROL 0 PPI Anisal Numbers Sex RRA RRRR RRR RRR RRR RRRR RR RRR ---- ---- --- --- --- --- ---- 33 333 3333 3333 333 33 3333 333 555 5555 555 555 5555 555 555 55 45 555 555 6666 666 667 777 7777 92 3456 760 123 4567 912 3467 69 n K "n "NN N n N N N N N x N "x n N "n h N N - - - - - - - - - - - - - - - - - - - - -- - - .. .... ... ... .... ... ... ... -- --- ---- --- --- ---- --- --- -- ---- ---- --- ---- -- --- ------ --- --- ---- ---- -- ---- - ---- --- ---- --- --- --- ----- ---- ---- --- -- --- --- --- - - - - - - - - - - - - - - - - - - - - -- -- --- --- ---- --- --- ---- ----- --- --- --- ---- --- --- --- A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentwas made. 480 A c indicatesonly a noodiagnosticcommentwas made. Pleas#r@4er to the Single TabulatedAnisalReport. Tissue InventoryPage: 269 TissueInventory(Ccntinuldl RikerLaboratOrin,Inc- 3H FN-3924:Too Year OralToxicitY-OncogenicitSytudyin Rats Table:4 Project Number: 0281CROO12 Species:Rat Dose Group Name: CONTROL 0 pps Tissue Name Animal Numbers Sex RRRRARRRRRRRRRRRRRRRRRRRR --- --- ---- ---- -- -- -- ---- 4444444444444444444444444 5 5 5 6 6 6 6 16 6 7778698999999999990000000 6790 1346 7 12 3456 789 023 456 7 F FFFFFFFFFFFFFFFFFFFFFFFF Adrenal Aorta Bone Narrow Brain Esophagus Eye Neirt Kidney Large Intestine LiverLung Lymph Node (sesenteric) Mammary Blind Ovary Pancreas Parathyraid .. .+. .... .... ..4 + + + + 4 + C ........c ... + C . .. + 4 + 4 .... ...+ ... ... ... .... .. ... ... .... ... 4 ... .. .C .. ...4 + 4 + 4 + C+ +C .... .... 4 .. .. .... C C C + 4 + + + . .... ... ... ... .... ...4 + 4 + .. ... ..+ + 4 ............... ...4 + + + + + 4 + 4 + 4 + 4 . ... .C . .. . .... ... .... ... ... .. .. . + + + ...................4 . + c C c + 4 + + + C C + C + C c ........ .... .... .... .4 + 4 + 4 ... .... .......C ....4 ..........C + ... .... ... ..c ... .... .. .. . + +cccccccccccccccc ccc cccc .. .... ... ... .... .4 . ... ... Pituitary Prostate SalivaryGland Small Intestine SpinalCard Spleen Stomach Testis/Epididysis ------------------------- c .. ..+ + 4 c ... .. c .. .... ...c .........4 + + c + + + ......... .. .... ...4 ... 4 + 4 .... .... . ...................4 + + + + + . .... 4 ................... ------------------------- Thyroid ... 4 + + .... ...4 ... ... ... .. Trachea . .... ... ... .... ... .+ + + + 4 + ..............+ .......... UrinaryBladder ........................4 Uterus ---------------T-h-e-f-ollowintgissue(sw)ere not requiredby protocol------------------ -- --- --- ---- --- --- --- --- - Bone - - - - - - - - - - - - --- - - - - - - - - - - - ClitoralBlind ------------------------- HarderianGland ------------------------- Lymph Node ------------------------- Lymph Node (abdominal) ------------------------- Lymph Node (thoracic) ------------------------- mesentary A + indicatesthat a diagnosis*as made. A - indicatesthat no diagnosisor commentwas made. 41 A c indicatesonly a nondiagnosticommentwas made. Pleasereferto the SingleTabulatedAniimlReport. Tissue InventoryPage: 290 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FN-3924:TNo Year Oral Toxicity-OncogeniciSttyudyin Rats Project Nuaber: 0281CROO12 Species:Rat Table:4 Tissue Name PreputialGland Skin So4t Tissues (abdomen) Soft Tissues (head) So4t Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifieTdissue General Comment Dose Group Name: CONTROL 0 ppe Animal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------4444444444444444444444444 5555555555555555556666666 7776888689999999990000000 67 90 13467 123 4567 89 02 34 567 FFF FFFF FFF FFFF FFFFFFFFF FF ------------------------- - ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- A + indicatesthat a diagnosisvis made. A - indicatesthat no diagnosisor consentvas made. 4 82 A c indicatesonly a nondiagnosticommentwas made. Pleasereferto the SingleTabulatedAnisalReport. Tissue InventoryPage: 291 TissueInventoryleontinued) RikerLaboratoriesI,nc. 3H FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose Group Name: CONTROL 0 ppe Tissue Name Animal Numbers Sex RRRRPRRRRRRRRRRRRRPRRRRAR ------------------------4444 44 44 444 444 4444 44 4444 4 6666666666666666666666666 01 1111 11 112 222 2222 333 333 3 9 12 345 678 91234 56 783 4567 89 FFFF FFFF FFF FFFFFFFFFFFFF F Adrenal .. .... ... ..4 + 4 .. ... .... .. Aorta Bone Marro* + + + 4 + c + + + + + c + 4 + 4 + + c + . .. .. .... ... .. ........... Brain Esophagus Eye Heart ... .... ... ...4 + 4 .. .. .... . + + + C ....C C C + C + C + + c c c c 4 + c + + + c 4 + 4 + 4 + C + + + + t4 . . C .... .. ... .+ ................4 + Kidney Large Intestine + + + 4 . . .. . . . 4 . . . . . . . . . . . . . C 4 + C . .... ...4 ........4 + + + Liver . . . . . . .. . . . 4 + 4 + 4 + 4 + + 4 . . . . Lung Lymph Node (sesenteric) Mammary gland .. ...4 + 4 . 4 + 4 .. ... ..4 . ...........* + + + 4 .. .. ...4 + + 4 + 4 + + c c c + + + + 4 .........c + Ovary + + 4 .. ... ... ... .4 + + . 4 ++ + Pancreas ... ... ...4 + 4 + 4 .. ... .... .. Parathyroid c c c c c c c c c c c c 4 c c c @c c c c c c + c + Pituitary Prostate . .. ... .c ... c .. .4 + 4 + + c + + c + ------------------------- SalivaryGland ..................c 4 c 4 + + c Small Intestine + 4 + 4 + 4 .........4 + + + ...... Spinal Cord ... .C .. .... ... .c + + + + + 4 + 4 + Spleen . ..4 + 4 .. . 4. t ... ... ... Stomach Testis/Epididysis .....................4 . ------------------------- Thyroid .... ... .... 4 .......4 + 4 + + + Trachea + 4 ...4 + 4 + + + 4 + 4 .. ... ... ... UrinaryBladder . ... ... .... ... ... ... . Uterus + + + 4 + 4 + 4 . ..* . ... .. .... ... ---------------T-h-e-f-ollowintgissue(sw)ere not requiredby protocol---------------- Bone ------------------------- ClitoralGland ------------------------- HarderianGland ------------------------- Lymph Node ------------------------- Lymph Node (abdominal) ------------------------- Lymph Node (thoracic) ------------------------- Herpentary ------------------------- A + indicatesthat a diagnosiswas side. A - indicatesthat no diagnosisor comeentwas "do. 43 A c indicatesonly a nondiagnosticommentwas made. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage: 292 TissueInventoryicontinued) RikerLaboriktorieIsn,c. 3N FN-3924:Two Year Dral Toxicity-OncogenicitSYtudy in Rats Project Number: 0281CROO12 Species:Rat Table:4 Tissue Name PreputialBland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) S6ft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose Group Name: CONTROL 0 ppo Animal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------4444444444444444444444444 6666666666666666666666666 0111111111222222223333333 9 12 3456 789 12345 6 70 34 5678 9 FF FFFF F F FF F FF FFF FFF FFF FFF ------------------------------------------------- -- --- --- ---- --- --- ---- ----- --- ---- --- --- ---- --- -- --- ---- -- ---- ---- -- ---- -- --- --- ---- --- ---- -- ---- - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - -- - - - - - - - - - - - - -- ---- --- --- ---- -- ---- ------ --- --- --- ---- --- --- -- A + indicates that a diagnosis was made. A - indicates that no diagnosis or comment was made. 484 A c indicates only a nondiagnostic comment was made. Please ri4er to the Single Tabulated Animal Report. Tissue Inventory Page: 293 TissueInventory(continued) RikerLaboratoriesI,nc. 3N FN-3924:Two YearOralToxicity-OncogeniciStyudyin RATS Project Number: 0281CROO12 Species: Rat Table:4 Dose Group Name: FN-3924 100 pps R R R R R R R R R R R R.R R R R R R R R R R R P R Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - Tissue Name 6677 777 777 7777 7777 77 777 77 9 9 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 12 2 2 2 2 2 7 80 1234 567 8902 3678 93 4568 9 Sex N N N N N N N N N N N N N N N N n N " N N N N n N Adrenal . . . . . . . . . . . . . . . . . 4 . . .. . . . Aorta Bone Narrow Brain c + + 4 + + + 4 + + + + + 4 + 4 ... .c .. .. .........4 ............... .. ... 4 + 4 + + .. .... ... ... ... Esophagus C ... ... 4 C 4 C + + + + 4 . ..4 + + C + + Eye Heart Kidney + 4 + 4 . .... ... ... .... ... .4 + + + + + + 4 + 4 + + + 4 ............. ..........+ .............. LargeIntestine + + + + + 4 + 4 + 4 + 4 + + ... ... ... . Liver .......4 . + ............. Lung . ... ... ... .4 + 4 + 4 + 4 .. ... .. Lymph Madelsesenteric) Mammary Blind Ovary + 4 ... ..... c + + + .. ... ... ..4 - --- --- ---- --- --- --- ---- - -- ---- ---- --- --- --- ---- -- Pancreas C .......C ....+ + + + 4 ....... Pirathyroid Pituitary c + c . ...c + c + c + c c + # 4 + 4 + c + + c c + + 4 .. . 4 .......4 + 4 . c + Prostate c ... .+ . .... ... .... .4 + 4 . SalivaryGland SmallIntestine c ......c ................. .......4 ............. SpinalCord .................+ ....... Spleen . ... ... ...4 ... .... .4 ... Stomach .. .... .... .. ...4 + 4 .. ... .. Testis/Epididysis + 4 ................. Thyroid C ......C . ... .. ... .. Trachea c ... ... c .. ... + 4 + + + 4 + UrinaryBladder c ..............4 + + ....... Uterus ---- --- --- ---- ---- -- --- -- --------------T-h-e-f-o-llowintgissue(sw)ere not requiredby protocol------------------ Bone - --- --- --- ---- ---- -- --- -- ClitaralGland -- ---- --- --- ---- --- --- --- Hirderian61&nd - --- --- --- ---- --- --- ---- - Lymph Kode LymphNode (abdominal) Lymph Node (thoracic) -- ---- ---- --- ---- --- --- -- --- --- --- -- --- --- ---- ---- ---- ---- --- ---- --- --- -- Nesentary - --- ---- --- --- ---- -- -- --- A + indicatesthata diagnosiswasmade. A - indicatesthatno diagnosisor commentwasBade. 485 A c indicatesonlya nondiagnosticcommentwas made. Ploistreferto the SingleTabulatedAnimalReport. TissueInventoryPage:294 TissueInventoryicontinued) RikerLaboratoriesI,nc. 3H FN-3924:Two Yearoral Toxicity-OncogenicitSYtudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Tissue Name PreputialGland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose Group Name: FN-3724 100 pps RRRRRBRRRRRRRRRRRRRRRRRRR Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - 6677777777777777777777777 990 0000 000 00 111 11 112 222 22 7801234567890236789345669 Sex n n n N n " N n N N N N N N n N n N " x N N n n N - - - - - - - - - - - ;-- - - - - - - - - - - - ---------------------------------------------------------------4 ---- --- -------------------------------------------------------------------------------------------------------------------------------------------------- A + indicatesthat a diagnosisNas made. A - indicatesthat no diagnosisor commentus lade. 486 A c indicatesonly a nondiagnosticommentvas made. Pleasereferto the SingleTabulatedAnimalReport. Tissue InventoryPage:295 TissueInventoryicantinued) RikerLaboratoriesI,nc. 3" FN-3924:Two Year Oral Toxicity-OncogenicitSYtudy in Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose Group Name: FN-3924 100 ppe Tissue Name Animal Numbers Sex RRRR RRR RRRR RRR RRR RRR RR RR R ------------------------3.33 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 7777777777777777777777777 333 333 444 4444 4555 555 55 55 6 0145990123456901234567890 NN NNNNNNNNNNNNNNNNNNNNNNN Adrenal Aorta Bone NarroN Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lymph Mode (sesenteric) NisearyBlind Ovary Pancreas ... 4 + + + .....4 . + 4 + 4 + 4 .. ...4 ... .. c + c ........... +4+ 4+4 + 4 + 4 + + ... ... ... .... ... + . ... ..4 + 4 + 4 + ...............c ... ... ... + + c c + + + + + + + 4 . + + ....... . .... ... .4 + 4 + + + 4 . +. + 4 .... ... ..* . ... ... 4 4 + + 4 + + + C C + + + 4 + 4 + + ............. .. .4 .............4 + 4 + 4 + 4 + ...4 + 4 + 4 + 4 + 4 .. ... ... ... 4 + + + c c . ...c c c ...c ...c 4 + + + 4 + ------------------------------------------------- c + c ... ... ..c + c .. ... ..4 . .. Parathyraid Pituitary Prostate SalivaryBlind +C +C C C+C ++C C C + C C +4 +C+ 4+4 C .............c ........... .... .... .C . ..C C 4 .. .4 + 4 + 4 + + + c ...........c + + c + 4 + 4 + 4 + Small Intestine + 4 C C + 4 + 4 + + + 4 + 4 ... .... .. .. Spinal Card Spleen .. .. .... .+ + + + 4 . 4 + + . .. .......+ . 4 ............ Stomach + 4 + 4 ... 4 ... 4 + 4 . ... .4 ... Testis/Epididysis Thyroid ............4 ............ + + + + c ..........c ........c Trachea UrinaryBlidder Uterus .. ... ... .... ... C + 4 . . . 4 + ..................... + C + ------------------------- ---------------T-h-e-f-o-lloningtissue(sw)erenot requiredby protocol----------------- Bone ClitorilGland HarderiinGland ------------------------------------------------------------------------- Lymph Node ------------------------- Lymph Node (abdoeinal) ------------------------- Lymph Node ithoracic) ------------------------- Nesentary ------------------------- 487 A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentwas made. A c indicatesonlya noodiagnosticcment was &ado. Pleasere4erto the SingleTabulatedAnimalReport. Tissue InventoryPage:296 TissueInventory(continued) RikerLaboratoriesI,nc. 3N FN-3924:Two Year Oral Toxicity-OncoginiciSttyudyin Rats Project Number: 0261CROO12 Species'Rat Table:4 Tissue Name Preputialgland Skin Soft Tissues(abdomen) Soft Tissues(head) Soft TissuesIleg) Soft Tissues(neck) Soft Tissues(thorax) Thymus UnidentifiedTissue 6eneral Comment Dose 6roup Name: FM-3924 100 ppe Anisal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------3333333333333333333333333 7777 777 777 7777 77 7777 77 77 7 3333334444444455555555556 0 145 89 0123 4569 0 12 345 676 90 m "n N n "N N n "N N n N 0 N n n "m n N n N ------------------------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- --- --- ---- --- ---- -- -- ------------------------- A 4 indicattehsata diagnoswiassside.A - indicattehsatnodiagnosiosrcommen*tismade. 488 A c indicatesonly a nondiagnosticommentwas made. Pleasereferto the SingleTabulatedAnisalReport. Tissue InventoryPage: 297 TissueInventory(continat,$' RikerLaboratoriesI,nc. 3W FN-3924:Two Year Oral Toxicity-OncogeniciSttyudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose Group Name: FN-3924 100 ppe Tissue Name Animal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------4 4444 4444 444 444 444 44 44 444 7777777777777777777777777 5556666666777777778888999 6692456789012346701469012 FFFF FFF FFFF FFF FFFF FF FFFFF Adrenal Aorta ...................4 + + c 4 + ...4 .. .+ .. . 4 ... ... C . ..+ BDne Narrow Brain . ... ...4 + 4 + 4 + 4 + 4 .. ... ... . ..................... Esophagus +C++ C4+ 4++ C .... ..c + + Eye Heart Kidney Large Intestine Liver Lung Lymph Node (sesenteric) + c + + 4 ... .... .4 + 4 c + + + .............4 ........... .........4 + 4 .. ... .... + c . ... ... 4 + 4 ............. .... .... ... ..4 ........... ... 4 + + + + + 4 + 4 + 4 + 4 ... ... ..+ + C + 4 ........C ......c + c c + + Mammary Blind + C ... + . 4 + 4 + 4 + 4 .. ... .... Ovary + c .. ... .... .4 . ... ... ..c 4 + Pancreas Parathyraid Pituitary Prostate SalivaryGland + 4 ... ..4 + * + + ... ... ... .C + + c c . ..c + c c .... .c ....c c c c 4 + + * . 4 ................c + + --- --- --- ---- --- ---- -- -- - + c ....................c + + SmallIntestine + C .... ... .... ... .4 + + + 4 ... Spinal Card Spleen Stomach Testis/Epididysis ... .... ... .... .... .. .4 c + + ......... ....... + + .......* ... ------------------------- Thyroid Trachea + c .... .... .4 + 4 .. .... .. c 4 + ......4 ............4 + 4 C 4 + UrinaryBladder + 4 + 4 . ..* .... .... .. .... ... Uterus + C .... .... 4 ... .. .4 .. c ++ --------------T-h-e-followingtissue@s,werenot requiredby protocol----------------- Bone ------------------------- ClitoralGland --- ---- --- ---- -- -- -- ---- - HarderianGland Lymph Node ------------------------- - - - - - - - - - - - - - - - - - - - - -I - Lymph Node (abdominal) ------------------------- Lymph Node (thoracic) Nesentary ------------------------------------------------- A + indicatesthata diagnosiswas ude. A - indicatesthatno diagnosisor cment was aide. 489 A c indicatesonly a nondiagnosticomnt was made. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage: 298 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FN-1924:Two Year Oral7oxicity-OncogenicitSytudyin Rats Table: 4 Project Number: 0281CROO12 Species:Rat Tissue Name PreputiilGland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifieTdissue General Comment Dose Group Name: FN-3924 100 ppe Animal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------4444444444444444444444444 7777777777777777777777777 5556666666777777778668999 6 892 4567 890 123 4679 146 90 12 FFFFFFFFFFFFFFFFFFFFFFFFF --------------------------------------------------------------------------------------------------- ---- ---- -- ---- --- -- -- ------------------------------------------------------------------------------------------------------------------------- A + indicattehsata diagnoswiassmade.A - indicattehsatnodiagnosiosrcommen*tasmade. 490 A c indicatesonly a nondiagnesticomment*as made. Pleasereferto the SingleTabulatedAnizalReport. Tissue InventoryPage:299 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FM-3924:Two Year Bril Toxicity-OncogeniciSttyudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose Group Name: Fil-3924100 ppe Tissue Naoe Animal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------444 444 444 4444 444 44 44 44 444 7777779869686808688806868 99 999 9000 0000 00 11 111 111 12 4567 690 123 4578 90 12 34 5789 0 FF FFFFFF FFFF FFFF FFFFFFFFF Adrenal ...4 . ... .... ... . Aorta + 4 + 4 .........c + + ........c Bone Marro* ... ... ...4 + 4 + 4 + 4 + 4 + + + + + + + Brain Esophagus Eye Heart Kidney LargeIntestine + 4 .. . 4 ................. + c ..........c 4 + + c ........ ...........c + + + * + 4 ......c + + + + + + + + + + + + ...........4 + ...............4 + 4 .. ... .. + . . . . . . . + + + + .. ... .. .. .4 c Liver . ... ... ..4 + + + 4 ... .. Lung Lymph Mode (sesenteric) .. ... .... ..4 ............. .....C + C .. .C + k + c + + + 4 + c + + c Mammary Blind + 4 + + C + + 4 . ... .4 . ... .... ..C Ovary . . .. . . . . . . . . . . . 4 + + + 4 + 4 . . . Pancreas .. ... 4 ..................c Pirathyroid C ... C C C ....C C + + 4 + c c c + 4 c c + Pituitary Prostate . . . + . . . . . . . . . 4 . ... .. .. ... ------------------------- SalivaryGland .....C + 4 . 4 + 4 ... c + + + + SmallIntestine ...........4 + 4 + 4 + + 4 . C Spinal Cord . ..4 ................... + Spleen .. .... ... ..4 + * . 4 . ... ... Stomach .........4 + 4 .......+ . + + Testis/Epididysis ------------------------- Thyroid ...........4 C 4 + 4 + 4 + c ... .. Trachea . .... ..+ . 4 c 4 ........... UrinaryBladder + + 4 + c + + . c ............c Uterus + + .. .... 4 .. ... .4 + * + 4 + ---------------T-h-e-f-ollowintgissue(s)were not requiredby protocol------------------ Bone ------------------------- Clitural61and HarderianGland ------------------------------------------------- Lymph Node ------------------------- Lyaph Node (abdominal) ------------------------- Lymph Node ithoracic) Resentary ------------------------------------------------- A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentwas made. 491 A c indicatesonlya nandiagnosticommentwas made. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage: 300 TissueInventory(continued) RikerLaboratoringInc. 3H FN-3q24:Too Yearoral Toxicity-OncogenicitSYtudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Tissue Name Preputial61and Skin Soft Tissues (abdomen) Soft Tissues thead) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose Group Name: FN-3924 100 ppe AninalNumbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR --- ---- --- ---- -- -- -- -- --4444444444444444444444444 7777778889668688aa888a0aa 9999990000000001111111112 45 678 90 123457 090 12 34 57 690 FFF FFFF FFF FFFF FFFFFFFFFFF -----------------------------------------4 - --- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- --- ---- --- --- --- -- -- -- - A + indicatesthat a diagnosisNat made. A - indicatesthatno diagnosisor consentwas made. 492 A c indicatesonly a nandiagnosticommentwas made. Pleasereferto-theSingleTabulatedAnisalReport. Tissue InventoryPage: 301 TissueInventor(ycontinued) Riker Laboratories,Inc. 3N FN-3924:Two Year Oral Toxicity-WcogenicityStudy in Rats Project Number: 0281CROO12 Species: Rat Table: 4 Base Group Name: FN-3924 30 PPI Tissue Name Animal Numbers Sex RR RRRR RRR RRR RRR RRRR RRR RR R ---- -- ---- ---- --- --- --- -3 333 333 7777 777 7777 777 7777 77 777 77 66 6166 666 777 7777 777 66B 689 1 2 3 4 5 6 7 0 9 0 12 3 4 5 6 7 6 9 0 1 2 3 4 5 "N n N N N N N " N n N nn "N N 8 n N n n N N N Adrenal Aorta Bone Narrow Brain . ... ... .... ... ..+ + + -- ---- --- --- ---- --- --- --- ---- --- ---- --- --- --- ---- -- --- ---- --- --- ---- --- --- Esophagus Eye Heart Kidney Large Intestine Liver Lung Lymph Mode (sesenteric) Hameary Gland Ovary Pancreas Parathyraid Pituitary Prostate c .. .c + + c c c c c c 4 + c c c c c c c c c c - ---- --- ---- -- ---- -- ----- ... ... ...4 + 4 .. .. ... .... + + . ... .... ... ... .... .. .... . --- --- ---- --- --- --- ---- -- . .... .. ..... .. .... .. .... . .. .... .... ...4 .. .... .+ . - ---- -- ---- ---- --- --- --- -- ----- --- ---- --- --- --- -- - - - - - - - - - - - - - - - - - - - -- - - - .. .... .... .... .4 + 4 + 4 ... c + c c c c c c c + c + c + + c c . . . cc ... . . . . . . . . . . . . .. . . . . C 4 + # + 4 + + 4 . . . . . . . . . c . . . . . . . . .. . . . Salivary Gland Small Intestine Spinal Cord c . .... .... .c .. ... ... .4 c 4 + - - - - - - - -- - - - - - - - - - - - -- - - - --- --- ---- ---- --- --- --- -- Spleen Stomach Testis/Epididysis . . . . . . . . . . . . . . . . . . . . .. . . . + + 4 + + . .... .... ... ... .* . . ... C ... .... .4 .... ... .. + Thyroid c . ...c + + + + + 4 + + + + + 4 + 4 + Trachea .... ... .... ... .... .4 . Urinary Bladder Uterus .. .... .4 . + + + C + + 4 . .... .. ---- -- ---- ---- --- --- ---- - ----------------T-h-e-followingtissue(s)were not required by protocol Bone - --- --- --- ---- --- --- --- -- ClitoralGland -- ---- --- --- --- ---- --- --- Harderian Gland ---- -- ---- ---- --- --- ---- - Lymph Mode - ----- -- ---- --- ---- ---- -- Lymph Node labdosinal) --- --- ---- --- ---- --- ---- - Lymph Node (thoracic) - ---- --- ---- --- ---- --- --- Resentary --- --- --- ----- -- ---- ---- - A + indicatesthat a diagnosismas made. A - indicatesthat no diagnosisor comment was Bade, 493 A c indicatesonly a nondiagnosticcommentwas made. Please refer to the Single TabulatedAnimal Report. Tissue Inventory Page: 302 TissueInventory(continued) RikerLaboratoriesI,nc. 3H Ffl-3924T:wo YearOral Toxicity-NcogenicitSytudyin Rats Project Number: 0281CROO12 'Species:Rit Table:4 Tissue Name Preputialgland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) S*oft Tissues (nick) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose group Name: FM-3924 30 ppe RRRRRRRRRRRRRRRRRRRRRRRRR Anisal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - 7777777777777777777777777 6666666667777777777888888 12 34 5678 90 12 345 678 90 12 345 Sex n N N N " m N N N N N N N N N N N N N " N " n N N ----------------------.... ... 4 ................. -------------------------------------------------------------------------------------------------------------------------- ---- --- ---- --- -- -- -- --------------------------------------------------- 4 9 4 A + indicatesthat a diagnosiswas side. A - indicatesthat no diagnosisor comment*is Bade. A c indicatesonlya nandiagnosticommentwas made. Pleasereferto the SingleTabulatedAnisalReport. Tissue InventoryPage: 303 TissueInventoryicontinued) RikerLaboratoriesI,nc. 3N FN-3924:Two Year Bral Toxicity-OncoginiciSttyudyin Rats Project Number: 0291CROO12 Species:Rat Table:4 Dose Group Name: FN-3924 30 ppe Tissue Name Animal Numbers Sex RRRRRRRRRARRRRRRRRRRRRRRR ------------------------3333333333333333333333333 7777777777777788889e88888 8aaa999999999900000000001 6769012345678901234567890 N n "n N n n "N"""NNN N N N n N x N N n x Adrenal Aorta Bone Marrow Brai.n Esophagus Eye Heart + 4 .....................c + ------------------------------------------- ---- -------------------------- + c c 4 c c c c c ...c ............ - - - - - - - - - - - - - - - - - - - - - - - --- + 4 ... ..4 . .... ... .. .... ... Kidney Large Intestine LivL,r, .... .... ... ... .... .4 + 4 + 4 + ------------------------......................... Lung Lymph Node (sesenteric) Mammary Blind Ovary .. . + + 4 + + 4 + 4 + 4 ... .... .. ------------------------------------------------------------------------- Pancreas Parithyraid Pituitary Prostate SalivaryGland SmallIntestine Spinal Card Spleen Stomach Testis/Epididysis . .... ... .4 + C + 4 . .... .4 + + 4 + ++ cc+ c4+c c++c ++ +c +4 +4+c + + +++. 4 .. .... C .. ..4 + 4 + ...........4 + + c + + c ...... . .... ... ...+ . 4 .. C4 +4+ ------------------------------------------------- + 4 .... ...4 .... .... ... ... . ...........4 . 4 + 4 + 4 .. . + + + 4 + + + + + + .........4 + + + + Thyroid Trachea + 4 + 4. ..4 + 4 + + .... ... 4 .. ... .. .4 + 4 + 4 + 4 .... .... .. .... . UrinaryBladder Uterus .......* + + c + + + + 4 .......c + ------------------------- Done ClitoralGland Marderian61and The follonintgissue(sw)ere not requiredby protocol------------------------------------------- ------------------------------------------------- Lymph Node Lymph Node (abdominal) Lymph Node (thoracic) Restntary - - - - - - - - - - - - - - - - - - - - - ---- -- ---- ---- ---- -- -- -- ---- ------------------------------------------------- A + indicatesthata diagnosiswas made. A - indicatesthat no diagnosisor commentwas side. 495 A c indicatesonly a nondiagnosticommentisismade. Pleasere4erto the SingleTabulatedAnimalReport. TissueInventoryPage: 304 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FN-3924:ToooYear OralToxicity-oncogeniciSttyudy in Rats Project Number: 0291CROO12 Species:Rat Table*.4 Tissue Name Preputial61and Skin SoftTissues (abdomen) Soft Tissues (head) SoftTissues (129) SoftTissues (neck) Soft Tissues (thorax) Thymus UnidentifieTdissue General Comment Dose Group Name: FN-3924 30 ppe Animal Numbers Sex RRR RRR RRR RRRR RRR RRR RRR RRR ----- -- ---- --- ---- -- ---- 333 333 333 3333 333 333 333 333 7 777 777 777 7777 6898 80 6888 9 aa 6099 999 9q9 9900 000 000 00 1 678 90 123 45 6769 0 123 45 6769 0 N N n N N N n n "xn N "m "x m N N "n n n "N --- --- ---- ---- -- --- ---- -- - - + - + - -+ - + 4 ... .... .. .... . -- ---- --- ---- --- --- --- ----- --- ----- --- -- --- ---- --- --- --- --- --- ---- --- --- -- ---- ---- --- -- ---- ---- ----- ---- -- ---- -- ---- --- --- --- ---- ---- -- --- --- --- --- ---- --- --- --- ---- --- -- - - - - - - - - - - - - - - - - - ---- - A + indicatesthata diagnosismas made. A - indicatesthatno diagnosisor commenttiesBade. 496 A c indicatesonlya nandiagnosticcomment*as side. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage:305 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FN-3924:Two YearOral Toxicity-DntogehiciSttyudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose Group Name: FN-3924 30 ppm Tissue Naae Animal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------- 4444444444444444444444444 8 80866a6a8 2222222223333333333444444 12 34 56 7890 1234 567 890 123 45 F FFFF FFFF FFF FFF FFFF FFF FFF Adrenal Aorta Bone Narrow Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lymph Node (sesenteric) ........................+ ------------------------- ------------------------------------------------- ... .c ......c + c ........... ------------------------.. .... .4 ................. .... .. .... .... .. .... .. .4 + ------------------------- 4 .. ... ... ... .4 . 4 . ... ... ......................... -- ---- --- - - - - - - - - - - 4 + - --+ Nassary Gland Ovary Pancreas Parathyroid Pituitary Prostate SilivaryGland Small Intestine Spinal Cord ... ... ...4 + 4 + 4 + 4 + 4 + c ...+ + .......................4 + .. .c ....c ....c c 4 + c . ... c c c + + C C ... C + C + C .....C C t + + C C + .............c + c c .. .c . ... ------------------------- + + C C C ......C + + C + c .....c + + ------------------------- ------------------------- Spleen Stomach Testis/Epididysis + + 4 ...................... ......................c + + ------------------------- Thyroid Trachea UrinaryBlitddtr + 4 + C . ..C + 4 + C ...4 + c ...4 c c + ...........c ..........c + + ... C ... ..+ + .. c c + c ...... Uterus C c + + C ... .... . + 4 + 4 + + . .. --------------T-h-e-followingtissue(sw)erenot requiredby protocol-------------- ------------------------- Bone ClitoralGland ------------------------- HarderianGland ------------------------- -- ---- -- -- --- --- ---- --- -- Lymph Node Lymph Node labdosinal) ------------------------- Lymph Node (thoracic) ------------------------- Nesentary -- -- -- ---- --- ---- --- ---- - A + indicatesthat a diagnosistiesmade. A - indicatesthatno diagnosisor commentwas made. 497 A c indicatesonlya nondiagnosticommentwas *ado. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage: 306 TissueInventorylcontinued) RikerLaboratoriesIlnc. 3H FN-3924:Two Year Oral TDxicity-UncogenicitSytudy in Rats Project Number: 0291CROO12 Species:Rat Table:4 Tissue Name PreputialGland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifieTdissue General Comment Dose Group Naze: FN-3924 30 pps Animal Numbers Sex RRR RRR RR RR RRR RRRR RR RRRR RR ------------------------4444444444444444444444444 Ba8a8a8a868a06B6680698a88 2222222223333333333444444 123 45678 90 12345 6 79 90 1234 5 FF FFFF FFFF FFF FFFFFF FFFFFF ---------------------------------------------4 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- A + indicatesthati diagnosis*asside. A - indicatesthatno diagnosisor comot wasmade. 498 A c indicatesonly a nandiagnosticcommentIsis&&de. Pleasereferto the SingleTabulatedAnisilReport. Tissue InventoryPage: 307 Tissueinventoryicontineed) RikerLaboratoriesI,nc. 3N FM-3924:Two Year Oral ToxicitY-OntogenicitSYtudy in Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose Group Name: Fil-392430 ppe RR RRRR RRRR RR RR RR RRRR RR RRR Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - 4444444444444444444444444 Tissue Name 4 444 555 55555 55 6666 66 66 66 7 6789012345676901234567890 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 Esophagus Eye Heart + 4 c 4 ... + + 4 .. .... .... ... ------------------------- ------------------------- ------------------------- + + C ..........4 + c .. .. . ------------------------- . ..4 ..................... Kidney LargeIntestine Liver ... ... ... .... ..4 + + + + + ------------------------.........4 . 4 + 4 + * + 4 ... Lung Lymph Node (sesenteric) ... ... .... .... ...4 + 4 + 4 .. . - ---- --- -+ ............... Hisearygland Ovary Pancreas Parathyraid + c + 4 + 4 + + + 4 + c + + c . ...4 ... + + C + 4 + + C + + 4 .. 4 ......... c c c c + 4 c c. ..4. . c ......c + + + c + c + c + c + + c + + c ....c c + + c + Pituitary Prostate SalivarySland SmallIntestine Spinal Cord + c + 4 c + .. . 4 . ... .. .... ... ------------------------- + + c .......c c ........c + + + + ------------------------- ------------------------- Spleen Stomach Testis/Epididysis ......................... ......................... ------------------------- Thyroid + + C + C ... C ... ..C + + + +C + 4 + + C Trachea + + c .... 4 .. ... ... ...c ... .. UrinaryBladder + + c . ...+ . C ... 4 .. ... .+ + + Uterus .. ... ... .... .... .4 + --------------T-h-e-followintgissue(s)werenot requiredby protocol----------------- Bone ------------------------- ClitaralBland ------------------------- HarderianSland ------------------------- Lymph Node ------------------------- Lymph Node (abdominal) ------------------------- Lymph Node (thoracic) ------------------------- Resentary ------------------------- A + indicatesthat a diagnosis*as made. A - indicatesthat no diagnosisor commentwas made. 499 A c indicatesonly a nondiagnosticommentwas made. Pleasereferto the SingleTabulatedAnimalReport, Tissue InventoryPage:308 TissueInventory(continued) RikerLaboratoriesI,nc. 3n FN-4924:Two YearOral Toxicity-OncogeniciSttyudyin Rats Project Nuber; 0281CROO12 Species:Rit Table:4 Tissue Name Preputialgland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifieTdissue General Comment Dose Group Name: Fff-392430 ppe Anisal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------444 444 44444 444 44 44 44 4444 4 8808288988888888608680B68 4444555555555566666666667 6709012345670901234567890 F FFFF FFF FFFF FFF FFFF FFF FFF ------------------------- -------------------------- --- ----- -- -- -- --- --- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- A indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor coment *as made. 500 A c indicatesonly a nondiagnosticcownt was side. Pleasereferto the SingleTabulatedAnigalReport. TissueInventoryPage: 309 TissueInventory(continued) RikerLaboratoriesI,nc. 3N FN-3924:Two Year Ural Toxicity-OnCO99nicitSYtudy in Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose Group Name: FN-3924 10 ppe Tissue Nate Animal Numbers Sel RRRRRRRRRRRRRRRRRRRRRRRRR --- --- --- ---- --- ---- -- -- 3333333333333333333333333 a0a6a8aB6868886660a68680 IIII II1 122 222 222 2233 333 3 12 345 678 90 12 3456 78 90 12345 N "n "N N N N NnNNNN NNn n"Nxn Adrenal Aorta Bone Narrow Brain Esophagus Eye ... .... .... .+ + + + 4 + 4 + 4 .. . ------------------------- ------------------------- ------------------------- + + c ..............4 + + + + + + ------------------------- Heart Kidney Large Intestine Liver Lung Lymph Node (sesenteric) Mammary Gland Ovary Pancreas ...4 4 + 4 + 4 + 4 .. ... ... . .. .... ...* .........* + + + + ------------------------- .. ... ... .. ............+ + +4+ 4+ .. .... ... .+ -----------------4 --- --- - ------------------------- ------------------------- + + c ............4 . 4 .. . Parathyroid + + C C + + C 4 + C C + + C C + + C .. ...* 4 Pituitary Prostate .. .. .... ...4 + 4 + C .. .+ + + + + + ... .... 4 + + ...........4 . SalivaryGland SmallIntestine Spinal Cord + + C 4 ...4 C 4 + 4 + 4 C + C . ... ..C + ------------------------- ------------------------- Spleen .. ... 4 .. .... .+ + 4 + 4 + 4 + 4 . Stomach + 4 + 4 .. ...c + + + 4 + 4 ...4 c .. .. Testis/Epididysis ... 4 .. 4 .... ... ... .... Thyroid + 4 C + + 4 ... 4 + 4 + 4 + 4 .. .... ... Trachea UrinaryBladder Uterus + + C .... ... ... .... ..4 + 4 + 4 + . ... ... .... .... ... .4 .. . ------------------------- --------------- The followingtissue(s)were not requiredby protocol------------------ Bone ClitoralBlind HarderianGland ------------------------------------------------------------------------- Lymph Node Lymph Made (abdominal) ------------------------------------------------- Lymph Node (thoracic) Nesentary ------------------------------------------------- A + indicatesthata diagnosis*as made. A - indicatesthat no diagnosisor coamt was made. 501 A c indicatesonly a nondiagnotticommentwas made. Pleasereferto the SingleTabulatedAnimalReport. Tissue InventoryPage:310 TissueInventory(continued) RikerLaboratoriesI,nc. 3H FM-3924:Tvo Year OralToxicity-bcogenicitSytudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Dose group Name: FM-3924 10 pps RRRRRRRRRRRRRRRRRRRRRRRRR Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - Tissue Name PreputialGland Sk Soifnt Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment II III1 12 2222 22 2223 333 33 1234 5676 90 12 345 678 90 12345 Sex N n n n n N n " N N N N " N N N N " N " N " n n N ---------------------------4 ------------------------------------------------------------ ----------------------------------------------------------------------- --------------------------------- --- --- ---- --- ---- - -- --------------------------- 4 + indicatesthata diagnosisfoasmade. A - indicatesthat no diagnosisor comment mas made. 502 A c indicatesonly a noodiagnosticommentwas made. Please re4erto the SingleTabulatedAnimalReport. Tissue InventoryPage: 311 TissueInventorylcontir-utd) RikerLaboratoriesI,nc. 3H Ffl-3924T:wo Year oral Toxicity-oncogtniciSttyudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Bose Group Name: Fli-392410 pps R RRRR RRR RRRR RR RRRR RRR RRR R Animal Numbers - - - - - - - - - - - - - - - - - - - - - - - - - Tissue Name 3333 444 4444 444 555 555 5555 6 67 890 123 4567 690 123 456 7690 Sex N N N N N N N 8 N N N N N N " N N N N N " N N Adrenal Aorta Bone Narrow Briin Esophagus Eye ... .... .... ... .... .. .... . -- ---- -- ---- ---- --- --- --- -- ---- ---- ---- -- -- -- --- -- ---- --- --- ---- --- --- --- - + + C + C + C + C ..........4 + + + + + .........+ --- --- ---- --- -- Heart Kidney Large Intestine .... .... .. .4 + + + 4 . .... .... .. .* .................4 + 4 + ---- ---- -- ---- --- --- --- -- Liver .. .4 . ... .... .4 . 4 + 4 . .... Lung Lymph NDde(sesenteric) MammarySlind Ovary ...4 + 4 + 4 .. .... ... ... .. ... - ---- --- ---- --- --- ---- --- ---- --- -- ---- --- ---- --- -- ---- ---- -- -- -- ---- --- ---- Pancreas + 4 ... .c .. ... .4 + 4 .. ...4 ... Parathyraid Pituitary Prostate ...4 + + c + c c + c + c c + + 4 + c + * . ......c 4 + + + + + 4 + + . c ..... + 4 . . c + + + ... * ......... SalivaryGland SmallIntestine SpinalCord Spleen Stomach . ..+ + + C 4 ... .... 4 + + C + C . ... -- --- ---- ---- --- ---- --- -- ---- --- --- ---- --- --- ---- - + + 4 ................ 4+ .. .... .... .. .. ... + 4+ Testis/Epididymis + * .. ... ..... ... ... .4 + 4 + + Thyroid Trachea . .. + + C 4 + + + C + 4 .. ... C .. ... + + . c ..............+ + 4 + UrinaryBladder . . . 4 + + c 4 . . . . . . . . . . . . .. . . . Uterus - - - - - - - - - - - - -- - - - - - - - - - - - ---------------T-h-e-f-o-llowintgissueisw)ere not requiredby protocol----------------- Bone - ---- ---- --- --- ---- --- --- ClitarilGland --- --- ---- ---- --- --- --- -- HarderianGland ---- --- ---- ---- --- -- -- -- - Lymph Node LymphNode (abdominal) Lymph Node lthoracic) Nesentary - ----- --- --- ---- --- --- ------ --- ---- --- ---- ---- --- ----- --- --- ---- --- --- ----- --- ---- ---- --- --- ---- - 5 0 3 A + indicatesthata diagnosisNis made. A - indicatesthatno diagnosisor comment*as made. A c indicatesonlya nondiagnosticcossent*as made. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage:312 Tissueinventory(COntinuld) RikerLaboratoriesI,nc. 3N FN-3924:Too Year OralToxicity-OnccgeniciSttYudy in Rats Table:4 Project Number: 0281CROO12 Species:Rat Tissue Name PreputialGland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (Ieg) Soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose Group Name: FM-3924 10 ppe Animal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------3 886B806886808888008688868 3333444444444455555555556 6789012345678901234567690 NN N N N n N N "N N "N N N n N N "n -------------------------------------------------------------------------- ---- -- ----- --- --- --- -- ------------------------- -------------------------------------------------------------------------- --- --- --- -- -- ---- --- -- - 5 0 A + indicatesthat a diagnosiswas &&do. A - indicatesthatno diagnosisor couent was made. A c indicatesonly a nandiagnosticcment was made. Pleasereferto the SingleTabulatedAnisalReport, Tissue InventoryPage: 313 Tissueinventor7 RikerLaboratoriesI,nc. 3H FH-@3924T:wo Year Oral Toxicity-UncoginicitSytudy in RatS Project Number: 0291CROO12 Species:Rat Table:4 Dose 6roup Name: FN-3924 10 ppe Tissue Name Animal Numbers Sex RRRRRRRRRRRRRRRRBRRRRRRRR ------------------------4444444444444444444444444 8a8a8a86890a896a8886a8a86 7777777776968888688999999 1234 5670 q0 12 34 5678 90 12 345 FFFFFF FFFF FFFF FFF FFF FFF FF Adrenal Aorta Bone Narrow Brain Esophagus .... ...4 + 4 + + + 4 + + + 4 + ------------------------------------------------------------------------- + 4 + 4 c + + * . 4 . 4 + c ....... Eye Heart -- --c -------------------- + + .......+ . .........4 + Kidney Large Intestine Liver .. .... ... .+ . ... .... 4 + 4 + 4 + ------------------------- . .... .... .... .. .... + 4 + + + Lung Lymph Node (sesenterit): Mammary Gland Ovary Pancreas Parathyroid Pituitary Prostate SilivaryBlind Small Intestine Spinal Cord Spleen Stomach Testis/Epididymis Thyroid Trachea + + 4 ... 4 +--# + 4@l+ 4 t,++ + - - - - - - - - - - - - - - - - - - -- - - --- c .................... ...4 C + + 4 ... .C + ... ... ..... ....c + 4 + c c ...c ...c + + c .... + C + + C.4 + + C + C + + + + 4 + c . . . . c c + . ...c . ... ... .c .........4 + ------------------------- . ...c + c + 4 c + + c c + c + c ....... ------------------------- ------------------------- ...4 ...........4 ......... ........................ ------------------------- ....c ... c ........c + 4 .. ... ... .c ............c ....... UrinaryBladder . ... c ... .... ... .... 4 .. ... Uterus ... ... .... .... .4 + c .. .. .. . ---------------T-h-e-f-ollowintgissue(s*)ere not requiredby protocol------------------- Bone ------------------------- Clitaral61and HarderianBlind Lymph Made Lymph Node (abdominal) Lymph Node (thoracic) hesentary ------------------------------------------------------------------------------------------------------------------------------------------------- 5 0 5 A + indicatesthata diagnosis*as made. A - indicatesthat no diagnosisor commentwas made. A c indicatesonly a nondiagnosticommentwas made. Pleasereferto the SingleTabulatedAnimalReport. TissueInventoryPage: 314 Tissueinventory(continued) RikerLaboratOritsI,nc. 3M FN-3924:Two YearOral 7axicitY-IMcogeniciSttYudyin Rats Project Number: 0281CROO12 Species:Rat Table:4 Tissue Name PreputialBland Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) soft Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Coment Dose Group Name: FN-3924 10 ppe Anisal Numbers Sex RRRRRRRRRRRRRRRRRRRRRRRRR ------------------------4444444444444444444444444 a6a6a88860a0886686068a868 7777777778620668686999999 1234567890123456789012345 F FFFF FFFF FFFFFFF FFFFFF FFF -- ---- --- ---- --- ---- -- -- ......................... --------------------------------------------------- --- ---- ---- -- -- -- ---- ------------------------- - - - - - - - - - - - - - - - - - - - - - - ---------- ---------------------------------------------------------------- A + indicatesthat a diagnosiswas made. A - indicatesthat no diagnosisor commentwas made. 506 A c indicatesonly a nondiagnosticcomnt was side. Pleasereferto the SingleTabulatedAnimalReport. Tissue InventoryPage: 315 Tissue Inventory(continued) RikerLiberatorieslInc. 3H FN-3924:Two Year Oral Toxicity-OntogenicityStudy in Rats Project Number: 0281CROO12 Species: Rat Table: 4 Dose Sroup Nate: FN-3924 10 pps Tissue Name Animal Numbers Sex RR RRRRR RR RRRR RRR RRRR RR RRR - - - - - - - - - - -- - - - - - - - - - - - - 44 444 444 44444 444 44 4444 444 60a 8999 999 999 9999 999 9999 9 99990 000 0000 00 111 111 11112 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 12 3 4 5 6 7 8 9 0 FFFF FFFF FFFF FFF FFF FFF FFFF Adrenal Aorta Bone Narrow Brain .. .c . .... ..4 + 4 + 4 + 4 + -- ----- --- --- ---- --- ---- - --- ---- ---- --- --- ---- ---4 ---- --- ---- --- --- ---- -- Esophagus Eye + 4 + C .. .4 + 4 + 4 + 4 ... 4 + C + + C + + - ---- ---- --- --- --- -+ +- Heart .. ..+ . ... ..4 . 4. Kidney .... ... 4 + 4 + 4 .. .4 + .. ... .. Large Intestine - ---- ---- --- --- ---- --- --- Liver + 4 + 4 + 4 + 4 .. .4 + ... ... ... .. Lung Lymph Mode (iesefit@twic) + + + 4 .+ 4 + 4,+ + +, + +,-4. 4c,+ - - -- - - - - - - - - - - MaiiiiarBylind + 4 + + c 4 + 4 + 4 + 4 + 4 + 4 .. ...+ + + c Ovary + + c ... .4 . * . .... ... ... .. Pancreas Parathyroid + 4 . ..c + 4 + + + * . 4 .. .c + + c + + . ..c.. ..c ...c c + + + + + c c + + * + Pituitary Prostate Salivary Gland Small Intestine Spinal Card +4 C . . . . . c .. . . . - --- ---- ---- --- ---- ----- - ... ... ..c . .... ... c + c ..... ---- --- ----- -- ----- --- --- --- --- --- --- ----- --- ---- - Spleen + 4 + 4 ... 4 + 4 + 4 ... Stomach + 4 .. .4 + 4 ...4 + 4 .. .... .4 + + + Testis/Epididysis --- --- --- ----- ---- ---- --- Thyroid . ..c .... ... ..4 + 4 + + + c + 4 . .. Trachea * + + C 4 . ... .... .... ..c 4 . + Urinary Bladder Uterus ... c .. .4 ... .... ... .c .. ... . ..+ + c + 4 .... ...+ ... ... .4 + ----------------T-h-e-followingtissue(s)were not requiredby protocol----------------Bone - - - - - - - - - - - - - - - - - - - - - - - - - ClitoralGland Harderian Blind Lymph Node --- ---- ---- ---- --- --- ---- ---- --- ----- --- --- ----- - --- --- ----- --- ---- --- --- - Lymph Mode (abdominal) - ---- --- ----- --- ---- ---- - Lymph Node (thoracic) Nesentary --- --- ----- --- --- ---- ------ ----- --- ----- --- --- --- A + indicatesthat a diagnosis*as made. A - indicatesthat no diagnosisor commentwas made. 507 A c indicatesonly a noodiagnosticcommentwas made. Please refer to the Single TabulatedAnimal Report. Tissue InventoryPage: 316 TissueInventoryfrontinued) RikerLaboratorietI,nc. 3N FN-3924:Two Year oral Toxicity-OncogeniciSttYudyin Rats Project Number: 0261CROO12 species:Rat Table:4 Tissue Name Preputial61and Skin Soft Tissues (abdomen) Soft Tissues (head) Soft Tissues (leg) So4t Tissues (neck) Soft Tissues (thorax) Thymus UnidentifiedTissue General Comment Dose Group Name: FN-3924 10 ppe AnisalNumbers Sex R RRRR RRR RRRR RRR RRRR R RR RR R ------------------------4444444444444444444444444 a88899999999999q999999999 q9q9000000000011111111112 6709012345676901231567B90 FFFFFF FFFF FFFF FFF FFF FFFF F ---- ---- ---- -- -- -- ---- --- - -- --- --- ---- --- --- --- ---------------------------------------------------------------------------------------------------------------------------- ---- -- ----- --- --- --- -- -------------------------- --- --- ---- ---- --- --- -- - A + indicatesthat a diagnosis*as made. A - indicatesthatno diagnosisor comment*as made. 508 A c indicatesonly a nondiagnosticommentwas made. Pleasereferto the SingleTabulatedAnisalReport. TissueInventoryPage: 317 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 20 509 internCaolrmqxm&nce AppendixItem E To:ChuckF. Chesney Riker Path and Tox 270-3S-05 From:SallyE. McCarville Riker Res Data Ops 270-3A-01 slb*cStt:atisticalAnalysisfor FM-3924 in Rats DaleF:ebruary 11 1985 The laboratoryvaluesand organweightdata for the studyof fluorocarbonFM-3924 in rats have been analyzed,and the resultsare presentedin the attachedtables.The statisticalmethodsused to analyzethe data are describedin the followingparagraphs. StatisticalMethods The means and stand-ard.deviatiofnosr percentorgan weight to bodyweightratios,organweightto brainweightratios,and laboratory data were detemined separatelyfor each sex and dose group. These data were analyzedusing Bartlett'stest for homogeneity of variance.If thistestwas not significantat a = 0.001,the data were furtheranalyzedby comparingeach treatedgroup to the controlgroupusinga two-tailedDunnett'stest at the a = 0.05 significancelevel.The resultsof Dunnett'stest have been indicatedby asteriskson the mean tables.If Bartlett'stest was significantat a = 0.001,the data were rankedand a two-tailed Dunnett'stest was performedon the ranks.These results have been indicatedby the pound sign (#) on the mean tables. References Bartlett'sTest Anderson,V.L. and McLean,R.A. (1974),Designof Experiments: A RealisticApproach,New York:Marcel Dekker, Inc., 16-22. Dunnett'sTest Winer,B.J. (1971),StatisticalPrinciplesin ExperimentaDlesign, New York, McGraw-Hill Book Company, 201-204. Appendix Item E Pe.ge 2 StatisticalAnalysis for FM-3924 in Rats SEM:emr 02/11/85 Rank Transformations Conover, W.J., and Iman, R.L. (1981), "Rank Transformationsas a Bridge Between Parametric and NonparametricStatistics",The AmericanStatistician,Vol.35, No. 3, 124-129. If you have any questions regarding the analyses, please let me know. )Zot SEM :emr Att. c: Cathy E. Ludemann -Len J. Sibinski MEE/RWH 511 InternalCorrespondence APPENDIX ITEM E TO: L.-"-Jt--Sib-tnski Riker Path and Tox 270-3S-05" From. S. E. McCarville - Riker Res Data Ops - 270-3A-01 Subject Date: Statistical Analysis in Rats September 24, 1985 of Microscopic Findings for FM-3924 The major microscopic findings of the Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats were statistically analyzed. For each organ/lesion classification the sexes were analyzed separately using a two-tailed Fisher's Exact Test comparing each treated group to the controls. An a = 0.05 significance level 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 significant difference between the controls and the treated group. References Fisher's Exact Test: Conover, W. J., (1971), Practical NonparametricStatistics, 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 512 APPENDIX ITEM F GROUP MEAN BODY WEIGHTS, INDIVIDUAL BODY WEIGHTS AND FEED JAR WEIGHTS OF MALE RATS RECEIVING FLUOROCHEMICAL FM-3924 IN DIET FOR TWO YEARS NOTES: Code I indicates a control group rat weight Code 4 indicates a FM-3924 - 100 ppm group rat weight Code 5 indicates a FM-3924 - 30 ppm group rat weight Code 6 indicates a FM-3924 - 10 ppm group rat weight Codes 11, 14, 15, 16 indicates the total feed Jar weight for the previous rat All weights are in grams 513 Appendix Item F Two Year Oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon PH-3924 in Rats .Group Mean Body Weights (g) + Standard Deviation Males Study week 0 2 4 6 6 10 12 14 16 18 20 22 24 26 28 30 32 34 Control 0 ppm Mean SW + SD (N)s 100 ppn Mean BW + SD (N)A 30 ppm Mean BW + SD (N):t 10 Mean 165.3 + 270.9 ; 334.0 + 390.7 + 429.2 + 456.2 + 475.5 + 493.2 + 502.9 + S15.3 + 526.8 + 542.3 + 550.4 -; 561.0 + 567.5 + 576.3 580.6 582.9 10.5 16.4 25.1 31.0 37.3 42.7 43.4 47.7 48.9 48.7 49.5 52.1 S3.0 54.3 55.0 56.7 57.4 62.5 (65) (65) (65) (65) (65) (65) (65) (65) (65) (6S) (65) (65) (65) (65) (65) (65) (65) (65) 168.2 + *253.6 -; *308.7 + *333.1 + *369.8 + *397.2 + *417.1 + *425.5 + *442.4 + *452.7 + *465.0 + *474.6 + *483.7 -+ *489.o + *50011 *510.5 *515.9 *507.1 10.1 15.7 22.1 26.8 29.4 32.3 35.2 36.7 37.3 40.5 41.2 40.5 41.6 41.2 43.1 44.6 44.8 46.5 (65) (65) (65) (65) (65) (65) (65) (64) (64) (64) (64) (64) (64) (64) (64) (64) (64) (64) 169.1 + 262.8 327.7 *361.6 + *404.8 + *433.8 + *454.8 *464.7 + 485.0 495.0 + 508.9 + 522.5 + S32.1 541.4 + 552.4 -+ 561.3 569.2 567.1 12.5 16.2 19.0 25.1 27.1 29.2 33.6 35.9 40.4 41.0 42.3 44.2 43.6 46.5 45.9 47.7 47.0 45.9 (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) 165. *258. *321. *355. *394. *428. *453. *466. 484o 495. 508* 521. 531. 541. 553. 561. 570. 566. Ln Number of animals weighed Significant difference from Control at the 5% level (Dunnett's t Test; cv= 0.05) AppendLx It.em F Two Year oral (Diet) Toxicity Oncogenicity Study of Fluorocarbon FN-3924 in Rats Group Mean Body Weights (g) + Standard Deviation Males Study Week 36 38 40 42 44 46 48 so S2 54 56 S8 60 62 64 66 68 70 Control 0 ppm Mean BW + SD (N)" 100 ppm Mean BW + SD ak (N)- 591.0 + 599.4 ; 608.4 + 612.9 ; 619*8 + 623.5 + 626.1 + 639.2 ; 638.6 + 654.3 + 661.6 + 668.0 + 673.2 + 674.4 + 664.5 ; 650.8 + 656.6 + 661.9 + 59.7 59.4 61.6 61.2 62.3 64.3 63.4 67.0 70.1 75.3 73.3 76.4 75.4 77.4 77.6 78.1 82.9 84.7 (64) (64) (64) (64) (64) (64) (64) (64) (64) (49) (4e) (48) (48) (48) (47) (47) (47) (47) *516.8 + *524.9 -; *530.4 + *536.5 -; *541.7 + *548.e + *552.3 + *559.9 -+ *S66.7 + *573.4 + *579.0 + *583.6 + *584.s + *589.2 + *589.5 -+ *591.0 + *592.9 ; *601.2 + 45.4 47.7 48.5 49.0 51.4 50.0 51.5 53.8 55.2 57.6 60.1 59.7 60.7 63.8 65.8 69.4 75.2 67.4 (64) (64) (64) (64) (64) (63) (63) (63) (62) (47) (47) (47) (47) (46) (46) (46) (45) (44) 30 ppm Mean BW + SD (N), 10 Hear 576.8 + 576.2 '; 586.8 + 592.0 -+ 598.8 + 604.6 + 611.0 + 619.1 + 623.8 + 627.3 + 633.S + 634.6 + 637.3 + 640.3 + 641.7 + 644*7 + 646.2 + 650.5 + 49.7 49.0 51.4 SI.2 51.6 52.0 52.8 54.8 57.8 58.2 58.0 60.0 59.9 62.2 66.7 70.9 72.5 72,2 (50) (50) (SO) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (SO) (50) (50) (50) (49) 575. 578. sea. 590* 59S 6010 60S 614. 618 620 *625 635 639 641 642 646 650 650 Number of animals weighed (-n Siqnificant difference from Control at the 5% level (Dunnettle t Test; a = 0.05) Ln Ar)pendix ttem F Two Year oral (Diet) 7bxicity Oncoqenicity Study of Fluorocarbon FM-3924 in Rats Group Mean Body weiqhts (9) + Standard Deviation males Study Week 72 74 76 70 so 82 84 86 Re 90 92 94 96 98 100 102 104 Control 0 ppo Mean OW + SD (M) 100 ppm Mean OW + SD a (N) - 658.3 + 660.0 ; 667.7 + 668.8 ; 670o6 + 663.1 + 668.1 675.6 678.9 690.0 + 686.0 + 678,3 + 677.5 67S.7 + 671.1 + 665.9 ; 642.0 + 86.3 81.7 84.9 83.0 85.2 OS.5 88.8 96.8 86.4 93.9 91.6 90.3 95.1 90.6 94.4 101.2 99.5 (47) (46) J46) (46) (46) (46) (45) (42) (41) (41) (40) (40) (38) (38) (37) (36) (35) *592.1 + *588.1 '; *600.2 + *598.9 -; *607.2 + *602.6 + *612.3 *610.2 *613.4 *617.7 + *610.9 + *595.3.+ *592.6 + *594.2 + *594.7 + *588.8 *568.6 69.2 75.7 68.7 77.6 70.9 67.8 68.3 70.2 69.8 71.7 71.0 72.7 74.5 74.4 74.8 84.0 97.0 (44) (44) (43) (42) (41) (40) (38) (38) (38) (38) (3R) (35) (34) (33) (32) (32) (32) 30 ppm 14ean BW + SD a (N)- 640.5 + 638.7 -; 651.9 + 654.8 + 656.5 + 657.5 + 657.3 + 653.4 + 64R.2 -+ 646.9 + 644.7. 634.3 + 630.9 627.6 + 630.0 629.0 + 628.9 73.4 76.9 68.3 77.2 67.5 64.6 67.5 66.3 70.9 77.5 79.4 09.1 91.4 98.1 90.4 95.1 76.5 (49) (49) (47) (47) (46) (45) (4S) (45) (45) (45) (44) (43) (42) (41) (39) (37) (35) 10 Mean 642.9 641.6 64R.3 650.6 652.5 648.8 648.9 653.4 655.9 656.8 6r)5.4 657.3 651.1 649,2 642*1 651.1 645.6 Number of animals weighed Ln significant difference from Control at the 5% level (Dunnettla t Test; 01= 0.05) 0% IWO YEAR ORAL(DIET@ TOX-ONC. STUDY OF F'M-3924 & FC-143 IN RATS EXF'. 0 OZICI:LC.ROCiJLZ' TEC:HI41CIF4N INITIALS:S MH TOE)RY-'S DATE:S 4/21/81 SEX OF RATS:S MALES ROOM NUMBER:S D-340 WEIGHT OF FULL FOOD JAR:S 500GRAMS WEEK 0 IR03516 015 FOOE)JRR IIS IR03517 OIS FOODJRR liS IR03518 OIS FOODJAR IIS IR03519 OIS FOUDJAR 115 IR03520 eis FOODJAR IIS IR03521 015 FOODJRR 115 IR03522 OIS FOODJAR Its IR03523 OIS F OODJAR@ - 03524 OIS t-CIQDJAR 115 IRO-@-'525 GIS FOODJAR 115 IR035e-@6 015 FOODJAR liS IR03527 OIS FOODJFIR Its IR03528 OIS FOODJAR IIS IROZ529 OIS FOODJRR IIS IR03530 eis FOOD-JAR 115 IR@3511 OIS FOOE)JRR IIS IR03532 eis FOODJRR 115 iRO351-'Z OIS FOODJRR IIS IR03534 OIS FOODJAR IIS IR03535 OIS FOOE)JRR 115 IR03536 OIS Fr'ODJAR LIS @- -3517 O:LS FOODJAR IIS IR035-@'S 015 FOODJAR LIS lROa539 OIS FOODJAR IIS IR03540 GIs FOODJRR 115 00?101:L67. eCi 00?201000.00 00?301162.70 00?401000.OG! 00?501157.OQ 00?601000.OQ 00?70117C4.70 00?801000.OCI 00?901168.00 010001roCIO.rir.) 010101157.4Q 010201000. 01.1@ Oi83Ol:L72. 9Ct Oi84OiOOO.eoQ 010501169.10 OC4 010701148.00 oieeeieelo. OQ 01090:L157.. 6Q OIIOOICIOO.OQ 011101159. 4L-,' Oli2OlOOL@.00 01130:LI57. 60 011401000.OQ 011501173.SQ 011601000. CiL-.1 Oli7Oll55.2Q 01180:10[40. OU 011901:Lecl. 5QI 0120EIlOC40. :LC4 012101:LCO. 5C,! 0122@IOOCI. e%';, 012301:L63. IC! 01240:LOC-,O.OQ 01250117r:;.OC4 012601000.OCJ 01270:LI62. 5U 01280;LOOO.OC! Oi2-coOl;i62S.o 8l3OOlo38O. 00 013101156. 9C4 01320IL400.OQ 01.330:L:L73.2r-4 01340:LIBOO. OC! 013501164.30 011601000.foQ Ola78JL165. 10 01180:LO430. 00 013901:L52.5Q 014001000.00 1 11 1 11 :1 :Li 1 11 1 11 :L I.:L J. :Li 1 J.1 1 11 1 11 :L ii 1 :Li :1 :Li I 11 I :L:L 1 ii 1 11 1 :Li 1 :Ll 1 :Ll 1 11 1 I:L 1 :Ll 1 11 1 11 167. E, 0 162.7 0 157 0 178.7 0 i6e. 0 157.4 0 :L72.9 0 169.1 01 :L49 a 157.6 0 :L59. 4 la 1.57.6 0 :173. 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IQ 4 FOODJRP 14S 014601000. OC, J4 IR03724 045 01470:LI78. SCJ 4 FNODJRR 14S 014801000.OC! 14 .33725 045 014901174.40 4 FOODJAF: 14S 015001000.IQ 14 IRO'-!@.726 04S 01510ii7l.90 4 FOOLA.JFIF'. 14S 015201000-00 14 lROa727 04S 01530ii53.:LQ 4 FOODJRR 145 015401000.:LQ 14 IR02728 04S 01550:LI75.SQ 4 FOODJRR 145 015601000.00 :L4 IR03729 045 01570:L:L72. 90 4 FOODJRR 145 015801000.00 14 IR02730 04S 015901:160.20 4 FOODJAR 14S 016001000.00 14 IR0373i 04S 01610:L:163. 20 4 FOODJRR 145 01620:LOOO.00 14 IR03732 04S 01630:L177.20 4 FOODJAR 145 01640:1000.1.0 :L4 IR01733 04S 01650:Ll.42. 90 4 FOODJRR 145 01660:LOOO.00 14 IR03734 04S 01670:L:166. SQ 4 FOODJAR 14S 01680:1000.00 :L4 IR03735 04S 016901169.20 4 FOODJAR 14S 01700:LOOO. :Lg :L4 IR03736 04S 017l8:LI55.50 4 FOODJRR 145 01720:LOOO.00 :L4 1003737 04S 01730:Li?e. 60 4 . @ODJRP 14S 017401000.OQ :L4 -.<03738 04S 01750:Li6i. 20 4 FOODJAR 14S 01760:LOOO.80 14 IR03739 04S 01770114:1.60 4 FOODJRR 14S 017801000.00 14 IR03740 04S 0179Oil52.30 4 FOODJRR 14S 018001000.10 14 IR03741 045 018101167.40 4 FOODJAR 14S 018201000.IQ 14 IR03742 04S Oi830:1:L74.40 4 FOODJRR 145 018401000.00 14 IR03743 04S 018501:L57.2Q 4 FOODJAR 145 018601000.OQ 14 IR03744 04S 01870JL:LS4. 00 4 FOODJRR 14S oiseoioee.oo 14 IR03745 04S Ole9Oli59.50 4 FOODJRR 14S 019001000.IQ 14 IR03746 04S Oi9lOll68.30 4 FOODJAR 14S 01920:1000.IQ 14 IR03747 04S 019301167.6Q 4 FOODJRR 14S 019401000.00 14 iRO3748 04S 019501185.iQ 4 FOODJRR 14S 0196010010.00 14 IR03749 04S 0197eii64.50 4 FOODJAR 14S 019SOiOOO.00 14 4RO3750 04S 019901157.eQ 4 ODJAR 14S 020001000.00 14 IR03751 045 020101176.90 4 FOODJAR 145 020201000.00 14 IR02752 04S 020301165.50 4 FOODJRR 145 020401000.OQ 14 iRO3753 04S 02O5Oil72.IG) 4 FOODJRR 14S 02egotooo.oo 14 IR03754 04S 020701163.6Q 4 0 :LeO. 4 0 169.1 0 178.8 0 :L74.4 e.i 17t. 9 0 :L53.1 0. :1 :L75.8 0 :L72. 9 0 J.60.2 0 :L63. 2 a :L77.2 0.1. :L42. 9 0 :L66. a 0 169.2 0. 1 155.5 0. 1-78.6-- 0 :L6:L.2 0 14t. 6 0 :L52.3 e.:L 167.4 0.1 :L74.4 0 :L57.2 0 :LS4 0 159.5 0.1 168.3 0.1 167.6 0 185.1 e 164.5 0 157 0 176.9 0 165.5 0 172.1 0 163.6 521 FOOL)JHR 14S 0208[110011. 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OC4 14 IRO--@756 045 021101186.30 4 FOODJAR 14S 021201000.IQ 14 IR03757 04S 021301163.00 4 FOODJAR 14S 021401000-00 14 -'0--,.758045 O2l5Oil64.iQ 4 jOE)JFiF-.1,4!F. 021601000.10 14 IRO-1'759 04S 021701166.30 4 FOOE- JRF.,14 @-@ C421801000-00 14 IRO--,.76004S 021901168.7Q 4 FOOE)JRR 14S 022001000.OQ 14 IR02761 05S 022101160.SQ 5 FOOL)JAR 15S 022201000.00 15 IR03762 05S 02220li52.00 5 FOODJAR 15S 022401000.OQ 15 IR03763 05S 022501187.20 5 FOODJAR 15S 022601000.IQ 15 IR03764 05S 022701193.9Q 5 FOODJRR 155 022SOiOOO.00 15 IR03765 05S 022901154.SQ 5 FOODJAR 15S 023001000.00 15 IR01-:766 05S 023101178.10 5 FOODJAR 15S 02320IOeO.00 15 IR03767 05S 023301177.40 5 FOODJAR 15S 023401000.00 15 IR03768 05S 02350ti69.00 5 FOODJAR 15S 023601000.eQ 15 IR03769 05S 023701187.30 5 FOODJAR 155 023801000.00 15 IRia3770 05S e239ed-t82. 2Q 5 FOOE)JRR i5S 024001000.00 15 03771 05S 024101150.SQ 5 FOODJRP 15S 024201000.00 15 IR02772 05S 02430li48.lQ 5 FOODJAR 15S 024401000.OQ 15 IR02773 05S 02450li5t.4Q 5 FUODJAR 155 024601000.00 15 IR03774 05S 024701179.40 5 FOODJRP 15S 024801000.OQ 15 IR03775 055 024901163.80 5 FOODJRR 15S 02500:1000.SQ 15 iRO3776 05S 025101185.OQ 5 FOODJRR 155 02520toeo.oQ 15 IR03777 05S 025301182.20 5 FOUDJAR 15S 025401000.00 15 IR02778 05S 02550:1184.40 5 FOODJRR 15S 025601000.10 15 IR03779 055 025701160.30 5 FOODJAR 15S 025801000.00 15 IR03780 05S 025901171.9Q 5 FOODJAR 15S 026001000.OQ 15 IR03781 05S 026101193.60 5 FOODJAR 15S 026201000.10 15 IR03782 05S 026301175.50 5 FOODJRR 15S 026401000.iQ 15 iRO3783 055 026501181.60 5 @'ODJRR 15S 026601000.00 15 -.,03784 05S 026701171.30 5 FOODJAR 15S 026801000.00 15 IR03785 05S 026901161.30 5 FOOE)JRR 15S 027001000.00 15 IR03786 05S 027101168.30 5 FOOE',JAR 15S 027201000.00 15 IR02787 05S 027301152.90 5 0-167.1 0 186.3 o.i 163 0 164.1 0. :1 166.3 0 168.7 0 160.8 0 152 0 187.2 0.1 193.9 a 154.8 0 178.1 0 177.4 0 169 0 187.3 0 182.2 0 150.8 0 148.1 0 15t.4 0 179.4 0 163.8 0 185 0 182.2 0 184.4 0.1 160.3 0 171.9 0 193.6 0.1 175.5 o.i 181.6 0 171..3 a 161.3 0 168.3 0 152.9 522 FOODJAP 15S 02740lOL-4Ci.2C4 15 IR02788 05S 02750117E..OQ 5 FOODJAR 15S 027601000-OCI 15 IRO@-7e9 05S 027701160. 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OE. 362.87 624.69 396.48 702.91 3SCi. 64 597.43 392.11 398.41 398.47 573.41 ' 410.80 ' 653.34 399.22 7:12.:15 377.0 6 718-06 ' 370.1.5 ' 688.70 ' 383.29 e 693.70 ' 395.70 ' 590.45 0.00 605.30 405.33 548.43 416.03 577.56 406-63 700.01 ' 378.15 ' 496.40 " 400-01 " 626.83 e 390.49 ' 750.82 378.44 380.22 652-17 391.27 739.56 ' 369.07 ' 606.62 ' 406-76 ' 689..95 371.62 665.45 377.17 743.38 0 389.77 ' 718.74 ' 37:L.57 ' 661.. O:L 380.40 5rdO. 07 428.64 5-QS. SJL 3-c#:L:.L2 655-21 393.42 579-68 405.69 15 5 15 5 15 5 15 5 15 5 15 5 15 5 15 5 15 5 15 5 15 5 15. 5 15 5 15 5 15 5 15 5 15 5 15 5 :L5 5 15 5 1.5 5 :L5. 5 1.5 5 15 5 15 5 :L5 5 0 15 5 :L5 5 15 5 1.5 5 :L5 5 :L5 5 :L5 363.54 654.08 362.87 624-69 396.48 702.91 360.64 597.43 392. :11 398.41 398.47 573.41 410.8 653.34 399.22 712.15 377.06 718.06 370.15 688.7 383.29 683.7 395.7 590.45 0 605.3 405.33 548.43 416-03 577.56 406-63 700-01 378.15 496.4 400-01 626.83 390.49 750.82 378.44 599.61 380.22 652.:L7 391.27 739.56 369.07 606.62 406.76 68-q.95 371.62 665.45 377.1.7 743.38 389.77 71.8.74 37:L.57 661..01 380.4 500-07 428.64 5.98.0:1 3.91. :L2 655.21 393.42 57.9.68 405. 650 946 IR038CIE. 05S 613. 50 5 613. 5 FOOL)JAR 15S 374.85 15 374.85 IR03809 05S 563.2, 5 563.23 FOODJRR 155 454.60 is 454.6 IR03810 05$ 604.53 5 604.53 FOODJAR 15S 397.86 15 -397. rd6 ipo3eii 06S 758.72 ' 6 758.72 'Ale F DJAR iSS 373.25 ' 16 373.25 IR03812 065 756.32 " 6 756.32 FOODJAR 165 38E.. 01 16 :LRCA3C-.'I:,r,,,E.S 1628.5 6 386-01 IB28. 5 FOODJAR 16S 16 371.72 lRO38i4 065 FOODJAR 16S IR03815 06S FOODJAR 16S iRG38i6 06S FOODJAR 16S IR03817 06S FOODJRR 16S IR03818 06S FOODJAR 16S IR03819 06S FOODJRR i6S IR03820 06S FOODJAR 165 IR03821 06S FOODJAR 16S IR03822 e6S FOODJAR 16S IR03e23 06S FOODJRR 16S IR03824 065 FOODJAR 16S IR03825 06S FOODJAR 16S IR03626 06S FOODJAR 16S IR03627 06S FOODJAR 16S IR03828 06S FOODJAR 16S IR03829 06S FOODJAR 16S IR03830 06S FOODJRR i6S IR03831 06S TA FOODJAR 16S IR03832 06S FOODJRR 16S IR03833 e6S FOODJAR 16S IR03834 OCS FOODJAR 16S 06S i )DJFIR16S 604.86 ' 406.31 " 590.39 376.04 649.35 389.73 635.93 393.92 65:1.52 399.Si r@04.72 388.42 736.31 370. 4:L 678.66 375.99 740.23 376.31 69:L.35 377.68 605.95 400.34 596-02 389.75 582.84 390.43 667.1.2 389.65 662.7e. 386.03 678.44 376.03 62:1.31 ' 400.30 ' 625.38 ' 0 3183.36 701.80 377.40 569.89 406.25 495.48 41e.76 606.32 6 1.6 6 :16 6 :16 6 16 6 :L6 6 :L6 6 :16 6 :L6 6 16 6 16 6 :L6 6 :L6 6 1.6 6 16 6 1.6 6 16 6 :L6 6 0 16 6 :L6 6 16 6 16 6 16 604.86 406.31 590.39 376.04 649.35 399.73 635.93 393.92 65:1.52 399.81 604.72 388.42 736.31 370.41 678.66 375.99 74rd.23 376.31 69:1. 35 377.68 605.95 400.34 596.02 389.75 582.84 390.43 667.12 389.65 662.78 386.ID3 678.44 376.03 62:L. 31 400.3 625.38 383.36 701.8 377.4 569.89 406.25 495.48 41.0.76 606.32 363.23 IR03836 06S FOODJRR 16S IR03837 06S FOODJRR 16S IR03e38 06S 567.94 6 314.05 16 647.29 6 394.17 16 582.34 6 567.94 314.05 647.29 394.17 582.34 947 FOODJAF, 16S IR03839 06S FDODJRR 16S IR03640 06S RAT # FOOC@JAR 16S @-A3$41 065 t JDJFIF'165 IR03842 06S FOOE)JRR 16S IR03843 06-q FOODJAR 16S IR03844 06S FOODJAR 16S IR03845 06S FOODJAR 165 IR03846 06S FOODJRR 16S IR03847 06S FOODJFIR ISS IR03948 OSS FOODJAR 16S iRO3849 06S FOODJRR 16S iRO3850 06S FOODJRR 16S IR03851 06S FOODJRR 165 IR03852 e6S FOODJRR 16S IR03e.53 065 FOODJAR 16S IR03854 065 FOODJAR 16S IR03855 06S FOODJAR i6S IR03856 06S FOODJAR 16S IR03857 06S FOODJAR 16S IR03e5S 06S FOODJAR 165 IR03859 06S FODDJRR 16S IR03860 06S FOODJAR 16S 4C'6.56 ' 16 642.49 ' 6 385.71 ' 16 0.06 6 IR03840 065 0.03 16 649.77 6 390.97 16 672.00 6 381.47 16 717.48 6 38ro.79 16 724.94 6 381. 06 16 549.40 6 398.62 16 754.69 6 390.13 16 60:t.08 6 .4@J...94 :L6 727.50 ' 6 178.51 ' 16 635.45 ' 6 394.43 ' 16 593.55 e 6 39@S. 93 ' :Ls 670.06 6 396.08 16 572.77 6 401.76 16 513.58 6 415.83 16 734.63 6 379.30 - 16 702.68 ' 6 371.92 ' :L6 720.43 ' 6 377.00 ' 16 603.21 ' 6 386.36 " 16 562.47 ' 6 4e3.25 16 707.96 ' 6 399.12 ' 16 685-39 ' 6 374.34 ' 16 0.06 406-56 642.49 385-71 0.06 NOT ON STUDY 0.03 649.77 390.97 672 381.47 717.48 380.79 724.94 381.06 549.4 398-62 754.69 380-13 603-08 43:1. 94 727.5 378.51 635.45 394.43 593.55 396.93 670-06 396.08 572.77 401.76 513.58 415.83 734-63 379.3 702-69 371.92 720.43. 377 603.21 386.36 562.47 403.25 707.96 399-12 685.39 374.34 -.A 948 TWO YEAR ORAL(DIET> TOX-ONC STUDY OF FM-3924 & FC-143 IN RATS TECHNICIAN INITIALS:S SW EXP.# 028iCROO12 TODAY'S DATE:S Se'24182 SEX OF RATS:S MALE ROOM NUMBER:S D-340,D-338 WEIGHT OF FULL FOOD JAR:S 550GRAMS WEEK 70 IR03516 -RAT # FOODJRR IR03517 RAT # FOODJAR IR03518 FOODJAR IR03519 FOODJAR IR03520 RAT # FOODJAR IR03521 FDODJRR IR03522 RAT FOODJAR IR03523 TR FOODJRR IR03524 FOODJAR IR03525 FQODJRR IR03526 FOODJRR IR03527 RAT FOODJRR IR03528 FOODJRR OIS IIS OIS IIS OIS IIS OIS IIS OIS IIS OIS IIS OIS IIS Ol.S IIS OIS IIS OIS 115 OIS IIS OIS IIS OIS IIS -0.04 ' IR03516 OIS -0-05 ' -0.03 ' IR03517 OIS -0.05 ' 616.70 ' 4:L9.20 ' 699.96 392.33 -0.03 iRO3520 OIS -0.06 ' 548.07 ' 440.41 ' -0.04 ' IR03522 OIS -0.05 ' 755.35 ' 0 397.54 ' 615.37 ' 394.15 ' 605.17 ' 400.57 ' 673.49 ' 393.27 0.01 IR03527 OIS 0.00 804.25 1 -0.04 11 1 -0.03 it 1 11 .-0.03 11 :L :Ll 1 -0.04 11 1 0 :Ll 1 11 1 I:L :L I:L 1 O.O:L I:L 1 IR03529 FOODJRR IR03530 FOODJRR IR03531 FOIDDJRR IR03532 FOODJAR a3533 -FOODJRR IR03534 FOODJRR IR03535 R19T FOODJAR IR03536 OLS IIS OIS i:Ls OJS I:LS OIS LIS OIS IIS OiS iis OIS iis OIS 738.38 398.65 ' 648.34 ' 402.52 ' 667.36 ' 392.14 ' 652.45 ' 395.40 ' 696.59 ' 396.74 ' 781.89 ' 364.50 ' -0.00 IR03535 OIS -0.00 568.93 it 1 11 1 11 -0.00 -0.04 NOT ON -0.05 -0.03 NOT ON -0.05 616.7 419.2 699.96 392.33 -0.03 NOT ON -0.06 5419.07 440.4:L -0.04 NOT ON -0.05 755.35 STUDY STUDY STUDY STUDY 397.54 615.37 394.15 605.17 400.57 673.49 393.27 0.01 NOT ON 0 804.25 392.76 STUDY 738.38 398.65 648.34 402.52 667.36 392.14 652.45 395.4 696.59 396.74 78.1. lB9 364.5 0 NOT ON 0 -568.93 STUDY 949 FOODJAR IR03537 FOODJAR IR0353e FOODJAR IR03539 FNODJAR a3540 RAT # FOODJAR iRO3541 FOODJAR IR03542 FOODJAR IR03543 RAT # FOODJAR IR03544 FOODJAR IR03545 FOODJRR IR03546 RAT # FODDJAR IR03547 TA FOODJAR IR03548 FOODJAR :LR@354-9 FOODJRR IR03550 Ri9T # FOODJRR IR03551 RAT # FOODJAR IR03552 FOODJAR IR03553 FOODJAR IR03554 FOODJRR IR03555 FOODJRR IR03556 TA FOODJAR IR03557 FOODJRR IR03558 FOODJRR tRe3559 RAT # FOODJRR IR03560 RAT # FNODJAR 03561 -TA FOODJAR IR03562 FOODJAR IR03b63 FOODJAR IR03564 115 OIS IIS OIS IIS OIS IIS OIS itS OIS IIS OIS IIS OIS IIS OIS IIS OIS IIS 015 IIS OIS liS OIS I:LS OISIIS OIS '-IIS OIS IIS OIS IIS OIS IIS OIS IIS OIS 115 OIS liS OIS IIS OIS ll.S OIS IIS OIS IIS OIS IIS OIS IIS OIS IIS OIS 43:1.35 521-51 441.89 765.28 385.03 594.38 404. rz;2 0. 0-< IR03540 015 0. o:i 626.61 399.29 646.80 402.23 0.136 IR03543 015 0.07 ' 76:1.48 ' 376.36 ' 672.32 ' 397.98 ' 0.05 iRO3546 OIS 0.07 782.33 398.96 ' 759.39 ' 366.73 ' 592.70 ' 405.39 ' 0.00 IR03550 O:LS -e.ee -0.04 IR03551 OiS -0.07 708.46 390.07 695.87 389.39 512.65 423 '.43 673 85 403.* 29 827.7 0 392.51 605.39 413.8'E543.64 423.27 0.01 IR03559 OIS -0*00 0.01 IR03560 OIS 0.03 705.06 0 385.90 631.42 388.50 608.04 392.88 626.10 11 :1 it 1 it 1 it 0.03 0.06 0.05 0 :L:L 1 IA 0.00 :L:L -0.04 11 1 0.01 11 1 e.ei 0 431.35 521. 5:1 441.89 765.28 385.03 594.3e. 4C$4. 82 0.03 NOT ON 0. 03 626.61 399.29 646.8 STUDY 402.23 0.06 NOT ON STUDY 0.137 76:L.48 376.36 672.32 397.98 0. ID5 NOT ON 0.07 STUDY 782.33 398.96 759.39 366.73 592.7 405.39 0 NOT ON 0 -0.04 NOT ON -0.07 708.46 390.07 695.87 389.39 51.2.65 423.43 673.85 403.2.9 827.7 STUDY STUDY 392.51 605.39 413.96 543.64 423.27 0.01 NOT ON 0 0.01 NOT ON 0.03 705.06 STUDY STUDY 385.9 631.42 388.5 608.04 392.98 626.1 950 FOODJAR 115 IR03565 OIS FOOD,!AR IIS IR03566 OIS FOODJAR IIS IR03567 OIS T$4 415. 51 , 11 724.26 ' 1 386.73 ' 11 551.07 ' 1 420-32 ' 11 822.4 1 0 415.51 724.26 386. 73 551.07 420.32 822.4 ODJAR IIS 388.73 it 386.73 iRO3568 OIS RAT FOODJAR 115 IR03569 OIS -0.07 IR03568 OIS -0.02 716.54 1 -0.07 11 1 -0.07 NOT ON -0.02 716.54 STUDY FOODJAR IIS 358.63 11 358.63 IR03570 OIS RAT FOODJAR IIS IR03571 OIS FOODJFIR IIS IR03572 elS 0.01 1 IR03570 OIS -0.02 11 681.47 397.33 604.18 ' 1 0.01 0.01 NOT ON -0. ID2 681..47 397.33 604.18 STUDY FOODJAR I.IS 361.23 " 11 361.23 IRS3573 SIS 695.02 ' 1 695.02 um FOODJAR IIS 390.70 ' it 390.7 IR03574 SIS 457.61 ' 1 457.61 FOODJRR IIS 314.05 314.05 IR03575 OIS 0.10 0.1 RAT IR03575 OIS 0.10 NOT ON STUDY FOODJAR IIS 0.11 TA 0 0 - IR03576 OIS RAT FOODJAR IIS IR03577 OIS FOODJRR IIS IR03578 OIS FOODJAR JAS IR03579 OIS FOODJRR 115 -0.04 IR03576 OiS -0.06 687.03 401.27 625.24 397.55 609.82 376.45 1 -0.04 JLI 1 11 -0-04 NOT ON -0.06 687.03 401.27 625.24 397.55 609.82 376.45 STUDY IR03580 OIS RAT FOODJRR IIS -0.22 IR03580 OIS -0.17 -0.22 -0.22 NOT ON -0.17 STUDY 71 951 TI-JCIYEAR ORFiL<[.)IET.'.T'O-X-Cit-4C:STUDY OF FM-3924 FC:-14--,.IN F-FITS EXF'.# 0281CRC*12 r... TECHNICIAN INITIAL-C:S SW TOE)Fl'il'ES)FITE:S 8/25/82 SEX OF RATS:S MALE F'oorl NUMe-EF.':-'[-).-330 WEIGHT OF FULL FOOD JAR:S 550GRAMS WEEK 70 IR03696 04S PAT FOO[)JAR 145 0.04 ' 4 iRO3696 04S 0.02 ' 14 0.04 iRO3697 04S 626.64 ' 4 FOODJAR 14S 385.92 ' 14 IR02698 04S 0.03 4 PAT IR0369S 045 0.03 FOODJAR 14S iRO7-:699 04S PAT # FOODJRR 14S 0.03 0.03 IR03699 045 0.04 14 4 0.03 :14 IR03700 04S 660.53 4 FOODJAR 14S IRCIZ701 04'-C; 36!f-.75 14 693.87 4' FOODJRR 14S IR03702 045 395.83 14 648.76 4 FOOC@JAR :r-4S 394.65 ' 14 IR03-iO:< 045 642.73 ' 4 FOOE)JAR 14S 368.74 ' 14 IR03704 04S 657.97 ' 4 T Fl 0 FOODJAR 14S 369.42 14 IR03705 04S 686.61 4 FOODJAR 14S 366.97 14 IR03706 04S 613.24 4 FOODJAR 14S 387.55 14 TFI 0 0 IR03707 04S 532.88 4 FOODJAR 14S 40:1.41 14 IR01-:708 04S 471.71 4 FOODJAR 14S IR03709 04S FOODJAR 145 IR03710 04S FCTODJAR 14S 342.55 14 559.87 4 398.66 14 584.59 4 381. 72 14 IR03711 04S RAT # FOODJRR 14S IR03712 04S 0.07 iRO371i 04S 0.05 516.53 4 0.07 14 4 FOODJAR 14S 392.93 14 IR02713 04S 645.77 4 @QODJAR 14S 381.05 14 03714 04S RAT # FOODJAR 14S IR03715 04S F.*AT FOOE)JRR 14S IR@3716 04S FOODJAR 14S 0. 0.@ IR03714 04S 0.03 0.04 IR03715 04S 0.03 66:<.79 3:78.14 4 0.03 14 4 0. C44 14 4 14 0.04 NOT ON 0.02 626.64 385.92 0.03 NOT ON 0.03 0.03 NOT ON 0.04 660.53 3.65.75 661. @7 385.83 648.76 394.65 642.73 368.74 657.97 STUDY STUDY STUDY 369.42 686.61 366.97 613. 24 387.55 532.88 401.41 471.71 342.55 559.87 398.66 584.59 3el. 72 0.07 NOT ON STUDY 516. 53 392.93 645.77 38:1.05 0.03 NOT ON 0..03 0.04 NOT ON 0.03 663.79 378.14 STUDY STUDY 952 717 04 5 1'-7 7 4 97 FCICIE-"JAF' 14:E. 71 14 5. 71 ci4s 54 4 FOOC?.JFiF- 14--- 402. 4!i " 14 I F,'O--7,19 04S PAT Cl. 05 " 4 IRC42719 04S FOODJFIP 14S 0. 07 ' 14 01-:720 045 0.07 ' 4 F-.'TFi# IPO@@'720 045 FCIODJFIP 14S Cl.02 " 14 0. 05 0. 07 6 54 4 2. 4@* 0.05 NOT ON 0.07 0.07 NOT ON ei.02 STUDY STUDY IP037il 4--14S 0. C45 " 4 F.'FTl # IRO--@.721 04S FOODJAR 145 0. 02 14 IF,07-722 C44S 0. 02 4 0. 05 0.05 NOT ON 0.02 0.02 STUDY FFIT # IRO-7.722 04S 0.02 NOT ON STUDY FOOE)JAR 145 IR03723 04S FOODJAR 14S IR03724 04S FOODJAR 14S IP03725 04S 0. 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J.1 ' 6:L2.69 ' 374.78 ' 734.49 37J.. 15 ' 675.17 ' 382.03 739.62 382.61 693.72 36-Co.06 608.78 393.87 ' 589.28 ' 0 394.54 " 578.16 392.28 659.17 387.26 670.25 391..60 674.43 ' 371.99 ' 618. 85 ' 382.97 ' 626.04 " 370.19 ' 697. 51 ' 361.99 5 15 5 15 5 15 5 15 5 15 5 15 5 15 5 15 5 :15 6 :16 6 0 :16 6 0 16 6 16 6 :16 6 16 6 IL6 6 J.6 6 16 6 :16 6 16 6 :L6 6 :16 6 16 6 0 16 6 J.6 6 :L6 6 :L6 6 :L6 6 16 6 16 6 16 0.00 62 7 9. 01 50ri. 65 412. 94 607 :-.71.41 6E.O. 58 :<99.24 586. 61 296. 12 612. 86 343. 01 0 NOT ON -ri.62 615.52 374.79 750.35 37'-43.5 749.02 STUDY 380.:14 826.3 --<68.73 602.:15 407.14 585.5 391. 21. 645.38 3-9-q4.7 635.68 391. 28 611. 39 405.1.1 612.69 374.78 734.49 37:1.15 675.17 382.03 739.62 382.61 693.72 369.06 60e.78 393. :r$7 589.28 394.54 578.16 392.26 659.17 387.26 670.25 39!L. 6 674.43 371.99 6118e.5 382.97 626.04 370.19 697.51 361. 9-q 956 F 0 J FlF.,16S 06S RFIT # FOOE)JAR 16S IROIS35 06S FOOE)JAR 165 06S F-CICIE.-JFiF,I'E-S OES FCIODJFIF' IE-S 06S FOOE)JAR i6S Cl.45 IR03834 06S 0. 03 60e,.77 6 84 5.@@,2. 315. --,0 6 5 --,:8.E. --@-72.75 583. 55 5 5. 2 16 45 0. 0.-:< NOT ON STUDY 16 0.03 6 E.(-SI. 77 1 E. 6 3. 84 6 5'-2Z.@ 38 16 315. -s 6 PL52. 86 16 372. 75 6 5e.3.55 16 388.29 IF'O--:@839 OE-5 FOODJAR 16S IF!03840 06S RFIT # FOOC-JAR 16S IR03841 C46S FOODJAR 16S IR03842 065 FOODJAR 165 IR03843 065 FOODJAR 165 IR03844 06S FOODJAR 16S IR03845 06S FOODJAR 165 IR03846 06S FOODJAR 16S IR03847 06S FOODJAR 16S IR01848 06S FOODJFIR 16S IR03849 06S FOODJAR 16S IR03850 06S 6:19. 42 387.95 -0. IR03840 06S -0. 05 651.82 375. 50 672.56 374.24 718.37 373.02 723.65 @ 378.53 552.35 ' 394.92 ' .76:L9.2 ' 370.35 ' 574.57 434.53 724.88 38:1. SC, 633.03 383.15 6 16 6 16 6 :L6 6 16 6 :19 6 1.6 6 16 6 :16 6 16 6 :16 6 16 6 -0.03 FOODJAR 16S IRO--<851 06S FOODJAR 16S IR03852 06S FOODJAR 16S IR03853 06S FOODJAR 16S IR03854 06S FOODJAR 16S iRO3855 06S FOODJAR 16S IR03856 06S FOCIDJRR 16S IR03e57 06S FOOE)JAR 16@c IR03858 06S FOODJFIP 16S .33859 06S FQODJAR 16S IR03860 06S FOOE)JAR 16S 99-149999999 391.21 ' 669.22 ' 385.12 ' 570.87 406.67 504.41 409. 5C, 726.56 ' 390.04 " 697.79 390.59 ' 728.96 ' 376.52 ' 600.46 ' 38:L.62 5!12.13 ' 405.24 " 711. E.*5" 66 680.48 @ 378. 3E. 99 16 6 :16 6 16 6 :16 6 :ig 6 16 6 16 6 :16 6 :L6 6 16 6 :Lie. 0 639.42 387.95 -0.03 NOT ON STUDY -e. e5 651.82 375. 5 672. 56 374.24 7:18.37 373.02 723.65 Z .7e-@js:t 552.--75 394.92 76:1.92 370.35 574.57 434.53 724.88 38:1. 8 633.03 383.15 599.76 391.2:1 669.22 385.12 570.87 406.67 504. 4:1 409.5 726.56 190.04 697.79 390.59 728.96 376.52 600.46 381.62 5!52.13 405.24 7:1:L.85 363.66 6eO.48 378.36 957 TWO YE TECHNICIAN INITIRLS:S SW TODAY-'S DRTE:S 9.-o'7182 SEX OF RATS:S MALE ROOM NUMBER:S D-340,D-338 WEIGHT OF FULL FOOD JAR:S EXP.# 550GRAMS .-143 IN RATS 0281CROO12 WEEK 72 IR03516 RAT # FOODJRR IR03517 RAT # FOODJAR IR03518 FOODJAR IR03519 FOODJRR IR03520 RAT # FOODJAR 1:RO352i FOODJAR iRO3522 RAT FOODJAR IR03523 FOODJRR IR03524 FOODJAR IR03525 FOODJAR iRO3526 FOODJAR IR03527 RAT # FOODJRR IR03528 FOODJRR IR03529 FOODJAR IR03530 FOODJRR IRS3531 FOODJRR IR03532 FOODJRR IR03533 FOODJRR 4"'03534 JDJRR IR03535 RAT FOODJRR OIS IIS elS IIS OiS IIS OIS IIS 015 IIS OI.S ilS OIS IIS OIS IIS OIS IIS OIS IIS OIS IIS OIS IIS OIS IIS OIS IIS OIS :LIS OIS I.I.S OIS i:LS 01-S IIS OIS IIS OIS IIS -0.03 IR03516 OIS -0.04 -0.01 IR03517 OIS -O.r62 6il.42 40:1. 44 697.63 394.77 -o -0.82 1 IR03520 OIS -0.02 5i8.54 44:L.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. O:L Bei..ee 390. 4:L 743.64 396.30 649.27 392.36 673.79 387.14 647.73 485.22 700.85 ' 395.63 ' 71B7.41 ' 370.43 ' 0.04 ' IR03535 OIS 0.01 1 1 -0.03 :11 :1 -0.01 11 I :L:L :L 11 :1 -0.02 :Ll i -i :Li 1 -0.00 :L:L 1 i:L 1. :L:L 1 :Ll 1 11 :L -0.00 :L:L i :Ll 1 11 :L 1.1 :L :L:L 1 i:L 1 11 :L 11 1 0.04 11 IR03536 OIS 559.24 1 TA 0 0 -0.03 NOT ON STUDY -0.04 -0.01 NOT ON STUDY -0.02 6:1:L.42 40J..44 697.63 394.77 -0.02 NOT ON STUDY -0.02 518.54 44.1.51 0 NOT ON STUDY -0.03 750.66 390.41 6:L5.5 393.66 606.63 399.3 673.71 397.98 0 NOT ON STUDY rd.ei. sol..Be 390. 4:L 743.64 396.3 649.27 392.36 673.79 387.1.4 647.73 405.22 700.85 395.63 787.41 370.43 0.04 NOT ON STUDY e.ei 559.24 958 FOODJAR IR03537 FOODJAR IR03538 FOODJAR IR03539 FOODJRR a3540 FOODJAR IIS 015 liS OIS IIS OIS liS OIS IR03541 OIS FOODJAR IIS IR03542 015 FOODJAR liS IR03543 015 RAT # FOODJAR IIS IR03544 OIS FOODJAR IIS IR03545 OIS FOODJAR IIS IR03546 OIS RAT # FOODJAR IIS IR03547 OIS FOODJAR IIS IR03548 OIS TFI FOODJAR IIS IR03549 OiS FOODJAR IIS iRO3550 OIS RAT FOODJAR IIS IR113551rdlIS R19T # FOODJAR IIS IR03552 015 FOODJAR liS IR03553 OIS FOODJAR IIS IR03554 OIS FOODJRR IIS 'IR03555 OIS FOODJAR IIS IR03556 OIS TA FOODJAR IIS IR03557 O:LS FOODJRR IIS IR03558 OIS FOODJAR liS IR03559 eis RAT # FOODJAR LIS IR03560 OIS RAT # FC)ODJRR :LIS 83561 OIS t-UODJFIR IIS IR03562 OIS FOODJAR itS IR03563 OIS FOODJAR IIS IR03564 O:LS FOODJAR its 430 37 480.61 494.07 764.15 391.12 604.58 404.41 621.94 399.26 646.43 407.50 -0.02 IR03543 OIS 0.02 ' 746.72 ' 379.:Le 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 61S -0.04 719.24 383.50 7ee.ig 381.49 512-62 419.08 670.72 408.5rd 822.2 0 393.39 591-58 385. :LS 534.08 383.82 0.01 IR0355 OJS -0.02 -0.00 IR03560 OIS 0.00 673.28 407.08 606.91 426.56 614.21 404.:13 618.66 396.99 11 1 11 1 11 1 11 1 -0.02 it 1 it 1 It 1 0.04 0 it 1 :It 1 It 1 it -0.03 -0.04 0 11 :L o.e:i It 1 -0.00 :Li 1 :L:L 1 :L:L 430.37 480.61 494.07 764.15 391-12 604.58 404.41 0.00 NOT ON STUDY 0.05 621.94 399.26 646.43 407.5 -0.02 NOT ON 0.02 746.72 379.18 673.7 402 0.04 NOT ON 0.03 759.2 402.2 767.95 STUDY STUDY 383.43593.4 3.97.819 -0.03 NOT ON -0.06 -0.04 NOT ON -0.04 719.24 383.5 700.19 38:L.49 512.62 4:L9.08 670.72 408.58 822.2 STUDY STUDY 393.39 591.58 385.:18 534.08 383.82 0. O:L NOT ON -0.02 0 NOT ON 0 673.28 407.08 606.91 426.56 6:14. 2:L 404.13 618.66 396.9.9 STUDY STUDY 959 iRO3565 FOODJAR IR03596 FOODJAR IR03567 TFI r--%ODJAR 103568 RAT # FOODJAR IR03569 FOODJAR IR03570 RAT # FOODJRR IR03571 FOODJAR IR03572 FOODJAR IR03573 VTR FOODJRR IR03574 FUODJAR IR03575 RAT * FOODJRR IR03576 RAT FOODJAR IR03577 FOODJRR IR03578 FOODJRR IR03579 FOODJAR IR03580 RAT # FOODJAR elS IIS OIS IIS OIS ilS eis IIS 015 115 OIS 115 OIS IIS OIS IIS OIS IIS OIS IIS 015 IIS @iS :L:LS OIS ilS OIS IIS OIS IIS OIS IIS 704. 74 N 391.41. 5 4 -q. 427.42 ' 841.7 ' 0 377.26 ' -0.00 IR03568 OIS -0.02 720.58 364.35 -0.03 IR03570 OIS -0.03 675.60 399.32 ' 564.92 ' 423.67 ' 689.63 0 395.70 504.7e 333.06 0.06 IR03575 OIS 0.08 -0.02 IR03576 OIS @0. 04 676.23 405.85 629.35 375.33 62:L.63 ' 372.57 ' -0.06 IR03580 OiS -0.06 1 11 11 1 0 11 1 -0.00 t1 1 :Li 1 -0-03 :Ll 1. 11 :L ili :L a :Li :L :L:L 1 0.06 11 :L -0.02 J.1 1 i:L 1. 11 I i;L 1 -0.06 :L:L 704. 74 392. 41 549. 93 427.42 841.7 377.26 0 NOT ON -0.02 720.58 364.35 -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 -0.04 676.23 405.85 629.35 375.3:1 62:L.63 372.57 -0.06 NOT ON -0.06 STUDY STUDY STUDY 960 TWO YEAR ORRL(DRET) TOX-ONC: STUDY OF FM-3924 FC-142 IN RATS EY@F'.# 0281CROO12 TE@HNICIRN INITIRLS:S SW TCIE)FIY-'D*FSITE:S 9/8/82 SEX OF RRTS:S MRLE ROOM NUMBEF,:S D-330 I WEIGHT OF' FULL FOOD JAR:S 550GRRMS ILi WEEK 72 IR03696 04S -RAT # FOODJRP 14S IR03697 04S FOODJAR 14S IR03698 045 PAT # FOODJAR 14S IR03699 04S PAT # FOODJAR 14S IR03700 04S FOODJRR 14S IR03701 04S TA FOODJAR 14S IR037e2 04S FOODJAR 14S IRLI:<7-A3 134S FOODJRR 14S IR03704 04S TA FOODJAR IR03705 FOODJAR IR03706 14S r64S 14S 04S FOODJAR 14S IR03707 04S FOODJAR 14S IR0370e 04S FOODJAR 14S IR03709 04S FOODJAR 14S IR03710 04S FOODJRR 14S IR037il 045 RAT # FOODJAR 14S IR03712 04S FOODJRR 14S IR03713 e4S cnODJAR 141-,- 03714 04S -RAT FOODJAR 14 IR03715 04S RAT # FOODJAR 14S Tri IR03716 04S 0. rd6 " IR03696 04S 0.07 ' 614.57 ' 386.65 0. :Lo IR03698 045 0.09 0. es IR03699 04S 0.09 648.59 367.34 656.14 ' 0 378.47 ' 640.95 ' 391.63 322,411 379.28 646.54 0 368.20 ' 659.93 ' 372.02 ' 622.57 ' 377.90 506.85 403.45 452. 7:L 316.68 549.26 403.99 560.65 387.27 -0.07 iRO3711 045 -0. :to 50:L. 9:1 383.99 636. 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NOT ON 0.09 0. oe, NOT ON 0.09 648.59 :<67.34 656.i4 STUDY STUDY STUDY 378.47 640.95 391.63 622.46 379.28 646.54 368.2 659.93 372.02 622.57 377.9 506.85 403.45 452. 7:L 3:L6.68 549.26 403.99 560.65 387.27 -0.07 NOT ON STUDY -0. :L 5k3:L.9:L 383.99 636. :L:l 371.53 -0. :L NOT ON STUDY -0-11 -0.11 NOT ON STUDY -0. :Ll 66:1. :L2 961 '43 71.1 .f FCICIEJFLF.' 145 IR03717 04S F OOE)JAR 145 04S FOO[)JAR 14S IRO-1:719 04S F.F,iT # ODJAR 14S iR@11-2C, 045 F*FIT # FC"--I[J,FIF.'14S IF*O 04S RAT FOODJAR 14S IR01722 04S PAT # FOODJAR IR02723 FOODJAR IR03724 FOODJAR IR03725 FOODJAR IR03726 FOODJAR IR03727 PAT # FOODJAR IR0372e FOODJAR IR03729 FOODJRR IR03730 FOODJFIR IP03731 FOODJAR IR03732 PAT # 145 04S 14S 04S 14S 04S 14.S 04S. 145 e4S 14S 045 14S 045 14S 04S 145 04S 145 04S FOODJAR 14S IRO:<733 04S RAT FOODJAR 14S IR03734 04S RAT # FOODJRR 14S iRO3735 04S RAT # FOODJRR 14S IR03736 04S RAT # FOODJRR 14S IR03737 04S RAT # FOODJAR 14S IR03738 04S FOODJAR 14S IR03739 04S FOODJRR 14S 33740 04S -@-UODJAR 14S IR0374i 04S FOODJAR 145 IR03742 04S FOODJAR 14S IR03743 04S FOODJAR 14S 7 5'.25 5C,5. 0 E-@-c9o. 41 60!!-.45 4 E,' -0. 00 IR02719 04S @ 0. 00 @ - El.00 " IF,03720 045 -0. 0 -0. 0 Cl I IR03721 045 -0.01 0.00 IR01722 045 -0.00 577.49 407.38 730.46 375.65 547.04 380.54 598. 4 E-. 386.14 -0.00 IR03727 04S 0.00 .576.09 376.21 603.47 3t32. 60 60:L. 3:L 382.63 724.52 367.64 0.07 IR03732 045 0.05 0. 03 IR03733 045 0.03 0.05 IR03734 04S 0. 05 0. 03 IR03735 04S 0. 04 0.04 IR03736 04S 0.05 0.04 IR03737 04S 0.02 573.13 394.15 450.06 389.27 554.09 392.19 605.22 365.4:L ' 554.77 " :,@e7.47 ' 576.47 ' 86 " 14 4 14 4 14 4 14 4 :14 4 14 4 14 4 :14 4 :14 4 :L4 4 :L4 4 14 4 :L4 4 14 4 14 4 :L4 4 :L4 4 :14 4 14 4 14 4 :14 4 14 4 J.4 4 14 4 :14 4 :14 4 14 4 14 -0. or_i -o.oci -0.00 0.00 -0.00 0.07 e.03 0.05 0.03 0.04 0.04 7 5. 25 505. 0 t--. -Z99. 41 605. 45 385. 4 0 NOT ON STUDY NOT ON t@-ic.i 0 NOT ON -0. o:l C-1 NOT ON 0 577.49 407.38 730. 46 375. 65 547.04 380.54 598.48 386.14 0 NOT ON 0 576.09 376.21 603.47 382.6 60:1. 31 382.63 724.52 367.64 0.07 NOT ON 0.05 0.03 NOT ON 0.03 0.05 NOT ON 0.05 0.03 NOT ON 0.04 0.04 NOT ON e.e5 0.04 NOT ON O.e2 573.13 394.15 450.06 389.27 554.09 392. :L9 605.22 365.41 554.77 387.47 576.47 399.86 STUDY STUDY STUDY STUDY S-TUDY STUDY STUDY STUDY STUDY STUDY 962 9 iri 7,1 04S FOOE)JRR 145 1 F.Cl 745 04S F.'TFl # FOQDJAR 145 IR03746 045 rnoDjAR 14S 5-i@' 1. 7.-;.; cl.0 t_-i lROa745 04S - Cl.01 @ 4 14 4 0.00 14 4 14 5E-.2.oe. :171. 7:@ r_i NOT ON -0.01 597.73 380.70 STUE)Y IRO@;1747 04S PFIT # FOOC.'-JFiR 145 04S PFIT FOODJAR 14S IR03749 04S RFIT # FOODJAR 14S IR03750 04S FOODJAR 14S IR0375i FOODJAR iRO3752 04S FOODJAR 145 IR03753 04S FOODJAR 14S IR03754 04S FOODJAR 14S IR03755 04S FOODJAR 14S IR03756 04S TA FOODJAR 145 IR03757 04S FOODJRR 145 IR03758 04S FOODJAR 14S IR03759 04S FOODJAR 14S IR03760 04S FOODJAR 14S TA IR03761 05S FOODJRR 15S IR03762 05S FOODJAR 155 IR03763 05S FOODJAR 15S IR03764 05S TA FOODJAR 15S IR03765 05S FOODJAR 15S IR03766 05S FOODJAR 15S IR03797 05S FOODJAR 15S IR03768 05S ODJAR 15S IR03769 05S FOODJRR 15S IR03770 055 FOODJAR 15S IR03771 05S FOODJAR 15S IR03772 05S El.0 4 IR02747 C145 ei. ei 14 0. 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NOT ON STUDY -0. :Li 668.27 398.45 627.77 377.02 626.27 364.67 -0.12 NOT ON STUDY -0. :L3 969 TI.JC,Ir'EFqFO:RFiL(E@IET' TO'.,.-'.-CSiTrU4DCY OF TEC.Ht-411-IFINIt4lTlFiLS:S :E::.-f.-:,FF--Fil',-z.M:F:IFL.E F,Clclti WEI,:IHT OF FULL FOOE*, JFiF*.:c-7 WEEF"" -c4 FC:-14--@.IN RATS IF:Ci!696 04---.TA 4 RAT # IF'02696 04S FCtOl:,JFiR1.45 -0.00 IR03697 C445 0 TR NOT 14 4 ON STUDY 0 611.69 FOODJAR 14S IF*01698 04EPAT FCIOE)JRR 14S 04S F'F.l7 FOCEJJRR 14S IRO"-Z'700 04S FOQDJRR 145 IR02701 04S FCiOl.-JFiR 14S l.PO3702 045 FCtOE)JFiR 14S IRO-7'70-' r:@4S FOO[J.JFIR 145. IP01-:704 04S FOODJRR 145 IF'02705 04S FCIODJAR 145 IP03706 045 FOODJr4R 14S IF'.03707 04S FIDODJAR 14-@-. IF.'OZ708 04S FOODJAR 14S IP037 9 04S FOODJAR 14S IP03710 045 FOODJAR 14S IR0371i 045 F'F.lT FCIODJAR 145 IRO!7i2 04S FOODJRR 14S IR02713 04S '-OODJAR 14S -.@C,12.71404S FOODJAR 145 IP@27i5 04S F.'FTl FOCI[)JAR 145 IR02716 04S FOODJAP 14S :<79.S.-:; -cli.00 IRO-7.698 04S co 0. Ci:l 0. 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Se. 3615. 22 STUDY STUDY 970- IF'@'l@@-717 04S 5 517' F Cif@[@jAR 14S 4C 14 4 f-IS 04S ClE. 91 4 ?1 FOOC.,JF-iR 14S 3 Cl. ci5 14 1:1. 05 IR.C7'@719 04S 0. cia 4 Cl F'AT # IPO--@.719 Cl4'-='. 0. ci,-7.; NOT 014 STUDY FCIODJHR 145 - Cl.05 14 0 t'O7-: 2 -A r-14S 0. C,I"i 4 0 .-.FIT IF:O@@::720 04S Cl. cic@I NOT ON STU[.,'-r' FC,Cll-jFiF,I 4,E. Cl.00 14 IPO-. 21 045 - Cl.cici 4 PAT IF'.C'7_-7:'@tl-44'-z -0. oci ci NOT ON STUDY F 001.,-.JAR 14F. - ei.0 ci 14 0 IF'02722 04S - Cl.CICI 4 0 F'FTl # IR02722 C44S -Cl. cri NOT ON STUDY FOCIDJAR 14S -0. OCI :14 0 IF:03723 04S 582. 49 4 5e.2. 49 FOCIDJAR 14S --9@7. 70 " 14 397. 7 IF*O--,.'72404S 707. 89 ' 4 707.89 T Fi 0 0 FCIC#DJFIR 14S 384. 52 ' 14 384.52 IR01725 04& FOODJAR 1R03726 045 FOOC@JAR 14S 4 14 ?:cIi1. e:l 4 -<64. 9:1 14 546.45 378.01 60:1. el 3'E-4.91 IR02727 04S RAT # 0.01 IR03-1@'27 04S 4 0.01 0.01 NOT ON STUDY FOOCfiJAF, 145 -0. 03 14 -0. 161 $8 0 4'-c 51-Z.-6.9 4 5$6. 93 Fr-,CiHJFiK.1'-4'S 31@6. 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FOODJAR 115 IR03517 OIS RAT # FOODJAR IIS IR03518 OIS FOODJAR IIS IR03519 OIS FOODJAR 115 IR03520 OIS RAT # FOODJAR IIS IR03521 OIS FOODJAR IIS IR03522 OiS RAT # @FOODJAR IIS I*R,0352:1 101,S FOODJAR 115 IR03524 TA FOODJFIR IR03525 OIS liS OIS FOODJAR IIS TA IR03526 FOODJAR IR03527 RFIT # FOODJAR IR03528 FOODJRR TA 'OIS IIS OIS 115 OIS JIS IR03529 OIS FOODJAR IIS TA IR03530 OIS FOODJRR IIS TA IR03531 OIS FNODJAR IIS TA 1 IR03516 015 TA Ia.01 0.01 IR03517 OIS -0 02 603 .34 396.28 690.76 38S.:19 0.01a IR03520 OIS 0.05 ' 488.86 ' 400.52 ' 0.00 IR03522 OIS 0.02 745* :19 381.7 614.8 0 :17'7.25 ' 623.46 ' 380.46 ' 0 69i.73 31DO.43 ' -0.01 1 IR03527 OIS 0.02 ' 795.61 ' 385.5 ' 0 749.97 ' 379.14 ' 0 653.38 ' 384.6 ' 677.50 ' 394.56 ' 0 NOT it 0 11 1 11 0 a 1 11 0 1 11 0 : ON STUDY 0.01 0.00 0.00 -0.01 -IR03532 FOODJRR IR03533 FOODJRR TA IR03534 FOODJAR SIS IIS OIS I:IS OIS IIS 654.91 392.77 ' 7:Ll.63 ' 389.93 ' 0 0 802.10 ' 1 .356.20 ' 11 0. ei 0.01 NOT ON -0.02 603.34 396.28 690.76 388.19 0 NOT ON 0.05 488.86 400.52 0 NOT ON 0.02 745.39 381.7 614.8 STUDY STUDY STUDY 377.25 623.46 380.46 69:1.73 380.43 -e.ei NOT ON 0.02 795.61 385.5 STUDY 749.97 379.14 653.38 384.6 677.5 394.56 654.91 392.77 711. 63 388.93 802.1 356.2 976 IR03535 015 0.05 0.05 RAT iRO2525 OIS 0.05 NOT ON STUDY FOOE)JRR IIS IR03536 OIS FOODJAR IIS IR03537 OIS PR-IT # 0. 15 571.99 413. 3Ci -o.rii IR035S7 OIS 11 1 It 1 -O.Ot 0.15 571.99 413. 3 -0.01 NOT ON STUDY )DJFIR ilS 0.05 11 0. 0!!, IR03538 OIS FOODJAR 115 779.88 1 361.81 11 779.88 361.81 IR03539 OIS 6 1 --tC:,2. :1 6:L3. 82 TFI 0 0 FOODJAR 115 397.33 :It 397.33 IR03540 015 0.00 1 0 en RAT # IR02540 OIS 0.00 NOT ON STUDY FOODJAR IIS -0.00 :L:l 0 IR03541 OIS 642.23 :1 642.23 FOODJRR IIS 370.65 11 370.65 IR03542 OIS 662.05 :1 662.05 FOODJAR IIS 380.27 it 380.27 iRO3543 OIS RAT # -0.01 IR03543 elS 1 @ -0.01 -0.01 NOT ON STUDY FOODJAR IIS 0. o:l :L:l 0. o:i IR03544 OIS FOODJAR IIS 761.35 1 353.4 :It 761.35 353.4 TA 0 0 IR03545 OIS FOODJAR IIS 665.64 1 388.30 :It 665.64 388.3 TA 0 0 :1-R]03546 01-q -0.00 :1 0 RAT # IR03546 OIS -0,00 NOT ON STUDY FOODJRR IIS -0.00 1.:1 0 I'RO3547 OIS FOODJAR IIS 740. 2.t :1 390.64 :It 740. 2:1 380.64 IR03548 Ois FOODJRR IIS 781.87 1 354.86 It 78:L.87 354.86 IR03549 OIS 607.48 :1 607.48 FOODJRR IIS 378.90 :1:1 378.9 VPJ IR03550 OIS -0.02 1. -0.02 RAT # IR03550 OIS -0.02 NOT ON STUDY FOODJAR IIS -0.03 :1:1 -0.03 IR03551 OIS -0-02 :1 -0.02 RAT # IR03551 OIS -0.02 NOT ON STUDY FOODJAR 115 -0.00 11 0 IR03552 OIS 7:15.12 :L 71.5.:L2 FOODJRR IIS 379.39 :1:1 378.39 IR03553 OIS FOODJAR IIS 711.39 1 37:L. 53 It 7:li.39 371.53 IR03554 OIS 1 514.09 FOODJAR I-IS TA IR03555 OIS FOODJAR IIS IRS3556 OIS FOODJRR JIS TR : )3557 OIS -FOODJAR IIS IR03558 OiS FOODJAR IR03559 RAT o I-tS OIS FOODJRR IIS IR03560 OLS 4:L3. 13 0 688.26 378.35 825.3 368.9 e 600. Sie 394.50 539.44 39:1.so -0.00 IR03559 OIS -0. 02 -0.00 :Li. 0 :L It :1 :It 0 1 :1:1 :1 11 1 -0.00 11 1 4:L3.13 688.26 378.35 825.3 368.9 600.88 394.5 539.44 391.8 0 NOT ON -0.02 0 STUDY 977 RAT FOODJAR IIS iRO3561 OIS FOODJAR IIS IR03562 OiS TA Frlll[)JIIIR*IS j3563 OIS FOODJAR IIS IR03564 015 FOODJRR IIS iRO3565 OIS FOODJRR IIS IR03566 OiS FOODJAR IIS iRO3567 015 FOODJAR IIS TA IR03568 015 RAT FOODJAR IIS IR03569 OiS FOODJAR 115 TA IR03570 OIS RAT # FOODJAR IIS IR0357i 015 FOODJRR ILS TR IR03572 015 TA FOODJRR IIS TA IR03573 OIS FOODJAR IIS TS IR03574 OIS FOODJFFR IIS IR03575 OIS RAT # FOODJRR IIS IR03576 OIS RAT # FOODJRR 115 IR03577 OIS FOODJAR IIS IR03578 015 FOODJRR IIS IR03579 OIS FOODJRR liS iRO3580 SIS RAT FOODJRR IIS IR03560 015 -0.14 705.71 352.68 611.49 0 39C',:14 67 389.48 630.28 376. e-2 704.86 370.68 561.57 391.97 845.3 356.7 0 -0.00 IR03568 OIS 0.03 726.82 342.73 0 @@ 0.00 IR03570 OIS 0.02 686.53 3-64.6 0 593.59 0 339.27 0 694.64 374.54 0 474.12 315.34 0.04 IR03575 OIS 0.01 0.02 IR03576 OIS 0.03 675.71 379.65 630.23 347.09 628.72 365.92 -e.ei IR03580 OiS -0.00 -0.00 1 11 1 0 11 1 11 1 11 1 11 1 11 1 11 0 1 11 1 1.1 0 1 @@ 11 1 :L:L. 0 1 0 11 0 1 11 0 1 11 1 11 1 11 1 it 1 11 1 It 1 11 -0.00 0.00 0.04 0.02 -0.01 NOT ON -0.14 705.71 352.68 611.49 STUDY' 390.14 619.67 3e-q.48 630.28 376.82 704.e6 370.68 561.57 391.97 945.3 356.7 0 NOT ON 0.03 726.82 342.73 STUDY 0 NOT ON 0.02 686.53 364.61 STUDY 593.59 339.27 694.64 374.54 474.12 315.34 0.04 NOT ON 0.01 0.02 NOT ON 0.03 675.71 379.65 630.23 347.09 628.72 365.92 -0.01 NOT ON 0 STUDY STUDY STUDY 978 TWO YEFIR ORFIL(DIET) TOX-ONCI STUDY OF Ftl-2924 & FC-143 IN RRTS TEC:HNIC:RFIN INITIFILS:S LJS E>@P. 0281CFR.*OC-112 TO[.,-R4,-'DSFITE:S SE"'. OF FFlTS:!F.MALE RCIOM t-4Utle-EF.:D'-3:3'0. WEIGHT OF FULL FOOD JFIR:S 5!5CI13RAt-15 WEEK 76 IR01696 04S FFIT # FOOC."JRR@145 IR03697 04S FNO@JA 14S IR03698 04S PAT # FOOR.,JAR 145 IR03699 04S PAT # FOODJRR 14S IR 3700 045 FOODJAR 14S 1*03701 04S TA F-'r-IDJAR 14S IR03702 04S FO-C@JAS 14S iP.03702 04S FOODJAR 14S IR03704 04S FOODJRR 14S IR03705 045 FOODJAR 14S IR03706 04S FOODJAR 14S TFI IR03707 04S FOODJRR 14S IR01708 045 TA FOOE)JRR 145 IR03709 04S FOODJAR 14S IR03710 04S FOODJAR 14S IR037ii 045 PAT # FOODJRR@14S IR03712 04S FOODJAR 14S IR03713 04S r IDJFIR 14S lmO37i4 04S @RAT # FOODJAR 145 IR03715 04S PAT # FC,ODJRR 14S IR03716 04S 0.06 IR03696 04S Cl.06 616. 66 396. 56 0.10 IR03698 04S 0. L14 0.07 IR03699 04S 0.04 662.04 --@:63.67 673.25 0 '360. 55 655.57 '-:?S52.5 5:1:-4.3 47C%.78 ' 666. 13 ' 354. 71 6 __k---3.9 367. eO 63-A.38 383.45 53:1.30 39so.90 467.08 0 337. '-;5' 562.50 ' 3.93.83 5C%0.45 372.07 0. 15 IR037ii 04S 0.18 517.-q4 384. '-;4 656.75 ' 3E.7.75 " -0. oo-; IR03714 04S -0.04 @ -0.05 " IR03715 04S -0. 02 @ 658.44 4 0.06 14 4. 14 4 0.10 14 4 0.07 14 4 14 14 4 14 4 14 4 14 4 :14 4 14 0 4 :14 4 0 14 4 :14 4 14 4 0.15 :14 4 :L4 4 14 4 -0.06 14 4 -0.0t. :14 4 0.06 NOT ON 0.06 6:L6. 66 396.56 0.1 NOT ON 0.04 0.07 NOT ON 0.04 662.04 363.67 673.25 STUDY STUDY STUDY 360. 55 655.57 395.25 5:L3.43 476.78 666. :L3 30-@4.7:1 666.3.9 367 638.38 383.45 531.3 399.9 467.08 337.95 562.5 393.83 560.45 372.07 0.15 NOT ON STUDY o.is 5:17.94 384. -q4 656.75 3F-;7.75 -0.06 NOT ON STUDY -0.04 -0.05 NOT ON STUDY -0.02 658.44 979 FOOI)JAR 14S TA IF'O'@7-717 045 FC,O[)JAF.* 14S IF.*03718 045 FOOE)JFIR 145 i -"-13719 04S @..I' # FR-,ODJAR 145 1 F.'O--7, 2 0 04S F..'TFl # FOCIE)JFIR 14S IR02721 0(*. 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FODDJFIF.'-14S IR03704 04S FOODJAR 145 IR03705 04S FOODJRR 14S lROa7O6 04S FOODJAR 14S iRO3707 04S FOODJAR 14S IR03708 04S FOODJAR 14S IR03709 4S FOODJFIR 14S IR03710 04S FOODJAR 14S IR03711 04S RAT # FOODJAR 14S IR03712 04S FOC)DJRP 14S IR03713 04S FOODJAR 14S IR03714 04S PFIT # FOODJAR 14S IR03715 04S t0 FOODJAR 14S IR03716 04S FC#ODJAR 14S IR01717 04S FOOE)JAR 14S IR03718 04S FOODJAR 14S -0.06 IR03696 04S -0.03 62e. 89 41.2.40 -0. e:i IR03698 04S -0-02 0. o:i IR03699 o4s 0 0.04 667.54 0392.22 658.54 41.@. le., 6!59'21* 392-84 403.@ 35 527 :L7 675.* 32 359.94 67:1. 3:L 368.44 649.76 38:1.5:1 537.88 412.59 45:L. 61 352.77 ' 567.:14 ' 393.82 ' 557.38 ' 383.71 -0.09 IR03711 04S -0.12 513.02 388.46 642.41 402.63 -0.11 IR03714 04S -0.09 -0.10 IR03715 04S -0.09 672. 9C-l 363-10 5:L5.67 (21.69 631.48 3S2. 5:L 4 -0.06 1.4 4 :14 4 -0.0.1 :14 4 0.01 :L4 4 14 4 14 4' :14 4 14 4 14 4 :L4 4 14 4 :L4 4 :14 4 14 4 14 4 --0.09 14 4 14 4 14 4 14 4 -0.10 14 4 14 4 14 4 :L4 -0.06 NOT ON STUDY -0.03 620.89 41.2.4 -0.01 NOT ON STUDY -0.02 0. ei NOT ON STUDY 0.04 667.54 392.22 658.54 419. iS 659 2:1' 392 84 403.35 527. 17 675.32 359.94 67:1. 31 368.44 649.76 38:1.51 537.88 4:L2. 59 45:1.6:1 352.77 567. :L4 393.82 557.38 383.?:L -e.eg NOT ON STUDY -0.12 5:13.02 388.46 642.4:L 402.63 -0.11 NOT ON STUDY -IB.09 -0.1 NOT ON STUDY -0.09 672.9 363.1 51.5.67 421.68 631..48 382.51. .989 IR03719 04S RFIT 0 FOODJRR 145 IR03720 045 RAT # FOODJAR 145 'IR03721 04S r FOODJRR 14S IR03722 04S RAT 0 FOODJRR 14S IR03723 045 FOOE)JAR 14S IR03724 04S FOODJAR 14S IR03725 04S FDODJAR 14S IR03726 04S FOOE)JAR 14S IR03727 045 RAT # FOODJAR 145 IR03728 04S FOODJRR 14S IR03729 04S FOODJAR 14S IR03730 04S FOODJAR 14S IR03731 04S FOODJAR 14S IR03732 045 RAT # FOODJAR 14S I*RCI:1733114 -q RAT 0 FOODJAR J.4S IR03734 04S RAT # FDODJRR 14S IR03735 04S RAT # FOODJRF, 14S IR03736 04S RAT FOODJAR 14S IR03737 04S RAT # FOODJRR 14S IR03738 04S FOODJFIR 14S IR03739 04S FOODJFIR 14S IR03740 04S TA FOODJAR 14S IR03741 et4S TR 3DJRR 14S IR03742 04S RAT FOODJAR 14S IR03743 04S FOODJAR 14S IR03744 94S FOODJAR 14S -0. C48 lROa7l9 045 -Ei.07 -0.0e. IR03720 04S -0.06 -0.07 IR03721 04S -0.06 -0.07 IR02722 04S @@08-0.08 585.46 427.53 703.00 426.61 556.49 382.84 614.56 384.32 -0.07 IR03727 04S -a.es 597.22 382.64 590.9r:; 393.23 6:18.25 406-09 717.51 378.46 -e.07 IR03732 04S -0.09 -0, 09 IR03733 04S -0.08 -0. 11 iRO3734 04S @ -0.09 -0.08 IR03735 04S -0.09 -e.ic, IR03736 04S - ci.0 E. -o.0;1 IR03737 04S - C-1 LN6: 569.54 ' 40E..47 ' 455-14 384.3Z 573.24 0 417 64 61--,. 0 380 90 0 -0.01 IR03742 04S -0. oe596. 56. 3". - oe589.6:e 369.97 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 :14 4 14 4 14 4 14 -4 14 4 14 4 14 4 14 4 14 4 14 4 0 14 4 0 14 4 14 4 14 4 14 -0.08 -0.07 -0.07 -0.07 -0.07 -0.09 -0.08 -0.10 -0.07 -0.01 -0. oe. NOT ON STUE)Y -0. ot -0.08 NOT ON STUDY -0.06 -0.07 NOT ON STUDY -0.06 -0.07 NOT ON STUDY 0 585.46 427.53 703 426.61 556.49 382.64 614.56 384.32 -0.07 NOT ON S TUDY -0.08 597.22 382.64 590.98 393.23 618.25 4e6. 09 717.51 378.46 -0.07 NOT ON STUDY -0.09 -0.09 NOT ON STUDY -0.08 -0. :1:1 NOT ON-STUDY -O.O-Q -0.08 NOT ON S TUDY -0.09 -0.1 NOT ON STUDY -0. ID6 -0.07 NOT ON STUDY -0.08 569.54 406.47 455.14 384.32 573.24 417.64 613.52 38e. 9 -0. 0:1 NOT ON -0.08 586.56 399.08 589.63 369.97 STUDY 990 iROS745 04S -0.06. 4 -0.06 RFIT IR03745 04$ 0. 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' 3C45. 2E; ' - Cl. oci :LR03719 045 -0. 02 0. oci IRO!720 04S -0. 00 0. oci IR03721 04S -0. oci -0.03 iRO3722 C,4 5 -0. 04 605. 77 ' 407.84 ' -0.04 ' IR03724 04S -0. 05 572.24 376.59 630. ei 385.62 -0. i3 IR03727 04S -0.11 626.34 ' 372.52 ' -0. 16 iRO3729 04S -0.15 640.34 380.87 ' 649.62 ' 0 414.64 ' 0.02 ' IR03732 045 -0. 02 0.01 IR03733 04S 0.00 -0.00 IR03734 04S 0.00.1 0. 01 IR03735 04S 0. oci -0.00 IR03736 04S -0.05 0.00 IR03737 04S 0.00 569.29 3LCti7.7 466.93 380.56 571. 11 396.30 562.71 390.2 0 -0.03 IR03742 04S 0.00 4 14 4 -0. oci 14 4 0.00 14 4 0. oci 14 4 -ci.03 14 4 :14 4 -0.04 14 4 14 4 14 4 -0.13 14 4 14 4 -0.16 14 4 14 4 0 14 4 0.02 14 4 o.ei 14 4 -0.00 14 4 0.01 14 4 -0.00 14 4 0.00 14 4 14 4 14 4 14 4 14 0 4 -0.03 14 62e,.97 385. 26 0 NOT ON -0-02 0 NOT ON 0 0 NOT ON 0 -0. oz NOT ON -0. 04 605.77 407.94 -0.04 NOT ON -0.05 572.24 376.59 630. ei 385.62 -0.13 NOT ON -0.11 626.34 372.52 -0.16 NOT ON -0.15 640.34 3ee.87 649.62 STUDY STUDY STUDY STUDY STUDY STUDY STUDY 414.64 0.02 NOT ON -0.02 0.01 NOT ON 0 0 NOT ON 0 0-01 NOT ON 0 0 NOT ON -0.05 0 NOT Ot4 0 569.29 3L:11.77 466.93 380.56 57:1.11 396.3 562.71 390.2 STUDY STUDY STUDY STUDY STUDY STUDY -0.03 NOT ON STUDY 0 1057 IRO.@:@'743 04S FCICI[@'T.HF.:. 14S IPO-;:744 04S FLICIL)JRR 14S IROa-45 04S F,F*iT F'r'ODJAR145 bi746 045 Fr-#O[jJRR 14':. iPo-- 74 '1704S. 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J.5 362.5 697.48 1079 FOOL)@TFIF: I -@S, iRoa8oo OSS PRT F OOE)JAF.' IfS I F"C,_-6,:CAI OV@NS FFIT FOODJAR 15S 1-93802 055 C,J FiF.-15S iROISOa 05S FCIOLYJAP i5S IF'01604 05S F"FiT # FOOL)JRR 15S iRO3805 055 FOOI)JRR 155 iRO3806 05S FOOE)JRR 15S IR03807 055 FQODJRR 155 IR03808 05S FOODJAR 15S IR03809 05S RAT # FOODJAR 15S :!tF.4.1 Cl. ciC, 05S cli,0 @- - ro. oci IR03801 05S 0. C-1 72C-.5Z' -:@ 31 6E.9.9E. 34C,. 92 0. 01 IR03804 05S 0. oci 626.34 369. 21 627. 2E. 3 8 'W. 55 607.61 38E..25 576.14 349.56 -0.00 IR03809 05S 0.00 IR03810 FOODJRR IR@3811 FOODJRF! 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I-C)l4 DATE. 5 3-9-cr.'3 SEX OF PATS:S MRLE F.10011 NLII-IBEF@;5 @-.3Ci WEIGHT OF FULL FOOL@ JAF'.:S 55EGP.Al-15 WEEK 98 lROa696 045 RAT # FOODJAR 145 IPO'697 04S RAT # FOODJAR 14S IR03698 04S PFIT 0 FOODJAR 14S IR03699 04S RAT 0 FOOE@JAR 14S iRO-,700 04S FOOE.-.JFIP14S IR03701 045 FOODJRR 14S :@' --<702 04S FL.,,[.,JAF*.145 IF,'O@703 045 RFIT FCIODJAR 14S IF,*03704 C445 FOOL)JFIP 14S iP@a7O5 04S FOODJAR 14S IR01706 04S FOOE)JAR 14S lROa7O7 045 FOOL)JAR 14S IRO!708 04S Fr-,C-i"-'JAF::14S IR01709 04S FOODJAR 14S iRO3710 rd4S FOODJFIR 14S IR03711 04S RAT 0 FOODJAR 14S IPOI-712 04S FOODJAR 14S iRO2713 045 FrIOE)JFik 14S 1 3714 04S P.FIT # FOODJAR 14S IR037i5 04S PAT # FOOE)JAR 14S iRC43716 04S PAT 0 0.02 IR03696 04S 0.05 -0.02 IR03697 04S 0.05 -0.02 iRO2698 045 0. C'4 -0. oci lROa699 04S -0. OC., 6:19. 96 38e,. 23 605.24 34!?. 17 f-8-,Cl. l.-@ 3 9 38 0. CE. IRO--@702 C'45 -0. 02 582.67 381. 05 68!5. 15 364.04 678.96 367.66 545.48 392. 17 455. 75 357.42 577.7--l 394.9E: 63 1 364.9E. 0.01,: iRO371i 04-c O.C,14 551. E:Cl 375.0--, 687. 2 c-I-' 7 --,;E.-:E: -0.01 IR03714 04':-@ 0. ci -o.oci iRO3715 04S - 0. ei-_-, -o.oci IR03716 04S 4 0.02 14 4 -0.02 14 4 -0.02 14 4 -o.oci 14 4 14 4 14 4 14 4 0. C16 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 0.06 14 4 14 4 14 4 -ci.oi 14 4 -0.00 14 4 -0. 00 0.02 NOT 014 STUDY 0.05 -0.02 NOT ON STUDY 0.05 -0.02 NOT 014 STUDY 0. C'4 0 NOT ON STUDY 0 639.96 388.23 605.24 34-Q.17 680.13 393.38 0.06 NOT ON STUDY -0.02 582. 87 381.05 685.15 384.04 67L=:.96 367.66 545.48 392. 17 455. 75 357.42 577.73. 394.98 633. 31 364.96 0.06 NOT ON STUDY 0.04 551.8 375.03 687. 2-co 373.88 -0.01 NOT ON STUDY 0.02 0 NOT ON STUDY -0.03 0 NOT ON STU[,Y 1086 FOODJAR 14S IR02717 045 FOOD-JAR 14S :LR03718 04S FOOL)JAR 14S 'IRL13719 04S p,-- 14S IF'01720 04S PAT # FOCILAJHF,. 14S IR03721 045 RAT # FOOL)JAR 145 IR03722 045 RAT # FOODJAR 14S IR03723 04S FOODJAR 14S IR03724 04S RAT FOODJAR 145 IR03725 04S FOODJRP 145 lROa726 04S FOODJAR 145 iRO1727 04S RAT FOODJAR 145 IR03728 045 FOODJAR 14S IP03729 04S FOODJAP 14S IROI-.730 04S FOODJAR 14S IR07-'731 045 RAT # FOODJAR 145 IR03732 04S R<FIT FOODJAR 14S IR03733-04S RAT # FOODJAR 14S IR03734 04S RAT # FOODJAR 14S iRO3735 045 RAT # FOODJAR 14S IR03736 04S RAT 0 FOODJRR 14S IR03737 04S PAT FOOE)JAR 14S Ir'%3738 04S F*,-',)JFi1R4S IR03739 04S FOOE)JAR 14S IR03740 04S FOODJAR 14S IR0374i 04S FOODJAR 145 -0. or; 402. e.e, 472.41 59L;. 33 4C'i.96 0. 07 IR03719 04S 0.05 0.06 iRO1720 04S 0.07 0. oe@ IFeO--<72i 04S 0.02 0.05 iRO3722 04S 0.07 ' 604.25 ' 406. 73 ' 0.02 ' IR03724 04S 0.00 581.02 369.69 6:L7. :L4 376.22 0.04 IR03727 04S 0. 04 ' 625.45 ' 373.57 ' -0.00 IR03729 04S 0.00 642.14 381. 98 0.02 IR03731 04S 0.01 0.02 iRO3732 045 -0.06 -0.00 IR03733 04S 0.00 -0.00 IR03734 04S -0.00 -o.on_ iRO3735 045 -0.02 -0.03 IR03736 045 0.00 0. oi IR03737 04S -0.02 542.50 391. te 447.65 " 341.25 ' 567.52 ' 385.30 570.78 389.68 14 4 14 4 14 4 14 4 14 .4 14 4 :L4 4 JL4 4 :L4 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 0.07 e. 0 t:. 0.09 0.05 0.02 0.04 -0.00 0.02 ' 0.02 ' -0.00 -0.00 -0.00 -0.03 0.01 -0. 02 402. 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T S,:@T 0 ':T1 t-;78 T '-7T4 ;HL4f'-3C,rl.-l AT T :@Hf .77.@C- 7 NO lClt4 T T0 I.T; "-:Z@ -E 6:3 T 'I'Ci 9T .? '?T 91"lf'ti-1-4 T :7t, ':4T '@4T 71 FOODJAP 16S IR03844 06S FOODJRR 16:Fl iRO3845 06S FOOE)JAR i6S IR03646 06S FI,Ctl.,JFiFi:6S J--<847 O-E-S RAT FOODJAR 165 IF:03648 06S TA FOODJAR 16S iRO3649 06S FOODJAR iES IR03850 06S FOODJAR 16S iRO3951 06S FOODJAR 165 iRO3852 06S FOODJAR i6S IR03e53 06S FOODJAR 16S IR03854 065 T Fi FOOE)JAR 16S IR03855 065 T Fi FOODJAR 16S iRO3856 06S FOODJAR 165 iRO3857 065 -)[)JAR16S I..03858 OES FOOE@JAR ISS IR02859 06S TA FOOE)JAR 165 IR03860 065 TA FOODJAR 16S 9999999999 358.4--4' ' 703.75 , 341.35 ' 545-79 ' 397. IE. ' 788.61 ' 367.66 ' -0.02 iRO3847 065 -0.02 794. --<E.' 0 356.56 " 623.81 " 366.53 62:1.76 360.99 664.43 404.64 567.74 387.21 507.78 412. 69 720.78 0 381. 82 711.69 0 367.42 ' 668.55 ' 503.63 ' 627. 9--@:' 370. OC, ' 525.56 401.07 767.91 0 86 706.88 0 35:1. 90 99 16 6 16 6 16 6 16 6 -0.02 16 6 0 16 6 16 6 :L6 6 :16 6 :16 6 :16 6 0 16 6 0 :16 6 16 6 iE 6 1 L; 6 0 16 6 0 :16 0 358.43 703.75 341.35 545.79 397.18 786.61 367.6e. -0.02 NOT ON STUDY -0.02 784.38 35iE..56 623.ei 366.53 62:1. 76 360.99 664.43 404.64 567.74 3e7.21 507.78 4:12. 69 720.78 39:L. 82 7:li.69 367.42 668.55 503.63 627.93 370 525.56 401.07 767.91 359.86 706.88 3 5 1. -ci APPENDIX ITEM F GROUP MEAN BODY WEIGHTS, INDIVIDUAL BODY WEIGHTS AND FEED JAR WEIGHTS OF FEMALE RATS RECEIVING FLUOROCHEMICAL FM-3924 IN DIET FOR TWO YEARS NOTES: Code I indicates a control group rat weight Code 4 indicates a FM-3924 - 100 ppm group rat weight Code 5 indicates a FM-3924 - 30 ppm group rat weight Code 6 indicates a FM-3924 - 10 ppm group rat weight, Codes 11, 14, 15, 16 indicates the total feed jar weight for the previous rat(s) All weights are in grams 1122 C.7 Appendix Item F Two Year oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon FM-3924 in Rats Group Mean Body Weights (g) + Standard Deviation Females Study Week 0 2 4 6 8 10 12 14 16 16 20 22 24 26 28 30 32 34 Control 0 ppm Mean BW + SD (N).! 100 ppm Mean BW + SD (N) 30 ppm Mean BW + SD (N) a 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 + 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 (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (64) (64) (64) (64) (64) 138.7 + *168.5 -; 211.4 + *224.6 + *237.7 *243.2 *241.6 *251.1 *256.9 *263.2 + *269.4 *273.2 + *278.1 *279.9 *285.0 + *282.2 + *289.8 + *292.1 + 17.4 12.6 16.3 17.2 20.2 21.3 21.0 23.5 22.6 24.0 24.4 26.3 27.4 27.2 28.5 28.3 31.5 31.8 (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) 135.8 + 163.3 213.6 234.3 + 252.0 261,6 *264.4 + *275.0 283.4 *292.3 + 299.3 + *303.5 310.3 + 312.9 321.7 + *318.6 *325.7 + *331.6 12.4 11.7 13.1 15.4 16.9 19.0 20.4 22.6 24.6 24.2 25.2 26.8 27.6 29.4 31.9 31.9 30.9 34.6 (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) 10 Mean 135.6 158.3 211.0 237.9 256.8 260.8 270.4 283.2 291.7 301.8 308.0 317.0 323.1 327.7 332.5 332.7 337.6 342.1 a Number of animals weighed Significant difference from Control at 5% level (Dunnett's t Test; cr 0.05) Appendix Item F Two Year oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon FM-3924 in Rats Group Mean Body Weights (g) + Standard Deviation Females Study Week 36 38 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 Control 0 ppm Mean BW + SD (N)S 100 ppm Mean BW + SD (N)2@l, 30 ppm Mean BW + SD (N)@@ 355.5 + 359.3 + 363.2 + 371.2 + 380.1 + 385.7 + 392.3 + 398.6 + 406.1 + 414.1 + 419.1 420.9 + 423.6 + 426.6 426.1 + 424.9 + 427.5 + 431.4 + 38.1 40.8 40.9 42.1 45.7 47.4 51.1 53.6 53.5 46.9 45.0 46.6 45.6 46.4 43.8 48.7 49.6 50.6 (64) (64) (63) (63) (63) (63) (63) (63) (62) (47) (46) (46) (46) (45) (43) (43) (43) (43) *300.5 + *302.1 + *306.3 + *311.4 + *313.9 + *317.8 + *321.1 + *324.6 *328.8 + *334.2 + *340.9 + *346.9 + *350.0 + *351.0 + *351.8 + *350.4 ; *357.7 + *360.8 + 34.1 35.9 37.3 38.5 40.2 42.3 43.6 45.4 47.9 47.3 51.2 54.3 54.9 57.1 59.3 58.8 59.4 61.3 (65) (65) (65) (65) (65) (65) (65) (65) (64) (49) (49) (49) (49) (49) (49) (48) (48) (47) 337.8 + 341.5 345.4 + 353.7 + 358.3 + 363.8 368.6 + 373.9 *379.3 + 388.0 + 396.0 404.1 + 408.0 411.5 + 416.5 413.7 + 422.4 423.5 + 34.8 38.6 36.4 38.6 40.0 43.0 44.1 47.4 47.9 50.1 53.6 55.6 57.2 59.3 61.9 64.3 64.3 69.4 (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (49) (49) (49) (49) (48) (48) 10 Mean 351.6 358.3 359.6 369.3 376.3 379.6 386.9 391.3 400.5 407.6 412.6 421.8 423.9 425.6 429.0 425.5 434.7 440.6 Number of animal weighed Significant difference from Control at 5% level (Dunnett's t Test; ct= 0.05) Appendix Item F Two Year Oral (Diet) TOxicitY Oncogenicity Study of Fluoroclarbon FM-3924 in Rats Group Mean Body Weights (g) + Standard Deviation Females Study week 72 74 76 78 80 82 84 86 88 90 92 94 96 98 100 102 104 Control 0 ppo Mean BW + SD (N)i 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 + 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 (43) (42) (42) (40) (39) (38) (37) (36) (35) (34) (34) (32) (31) (30) (26) (25) (25) 100 ppm Mean BW + SD (N)A *366.4 + *371.4 -; *373.4 + *369.3 + *378.7 + *378.2 + *383.9 + *378.3 ; *389.7 + *389.7 + *392.6 *399.1 + *402.6 ; *402.6 + *396.9 + *402.3 + *397.8 + 63.9 67.0 67.9 69.4 68.7 72.1 74.6 80.9 80.7 85.3 89.1 90.0 87.8 89.9 88.7 86.0 88.3 (47) (47) (46) (46) (43) (42) (42) (42) (41) (40) (38) (36) (36) (36) (36) (35) (34) 30 ppm Mean BW + SD (N) 429.9 + 435.1 442.1 438.3 + 444.9 *436.4 + 443.8 *443.9 + *445.5 *442.1 + *448.9 *440.1 + *445.6 -+ *444.9 *435.5 + *438.6 + *425.2 62.4 64.4 64.4 66.0 67.6 73.1 74.7 83.5 77.5 79.0 77.6 71.0 65.0 67.9 72.8 73.0 79.1 (47) (47) (47) (47) (47) (47) (43) (43) (38) (38) (36) (34) (31) (30) (29) (26) (26) 10 Mean 449. 455. 458. 458. 466. 467. 475. 490. 486. 494. 487. 486. 499. 494. 492. 490. 484. a Number of animals we ighed Significant difference from Control at 5% level (Dunnett's t Test; + 0.05) Ln TWO YERF: ORFIL(DIET> TOX-Ot4C STUDY OF FM--k924 & FC-14 3 IN RATS EVF'. 02P-.ICROOI'2 TECHt4IC:IFIN INITIRLS:S MH TOEAFlIr'-*E')SATE:S 5,-'7,-'$1 SE@-' OF RATS:S FEMALE F;.'CIOMNLII'18EF::S 40, E)-3--<8 14EIGHT OF FULL FOOD JAP:S 50OGF<At4S ,'WEEK 0 IR04576 OIS OO-'lOOi5l.6Q IF*045-177 01$ 00?200141.2C! 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ORAL(E,IET) To>e.-ONE* STUDY OF FM-2924 *.-FC-143 IN EXP.0 0281CROO12 TECHt4ICIA14 INITIALS:S MH TODRIT'IS DATE:S 4/e,/e2 SEX OF RATS:S FEMALE POOtl NUMBEP:S D-340..D-338 14EIGHT OF FULL FOOD JAP:S 650GRAMS RATS @IEEK 49 IR04576 RAT # iP@4577 FOODIAP iPO4578 IR04579 FOODJAR IR04580 iRO45el FOOE)JAP IP045e2 iP@45e3 FOOE)JAP IP04594 IR045e5 FOOE,,jAF, TA IR@45e6 IR045e7 FOOC,JAP IP045ee IP@45e? FOODYAR iPO4590 IR04591 FOODJAR iRO45?2 IP04593 FOODIAP IP045?4 IP04595 FOODJAP IR04596 IP04597 FOODJAP IP@459e IR04599 FOODIAP iPO4600 iPO4601 FOODJAP IP04602 '04601 rIO011JAR IR04604 IR04605 FOODJAP IR04606 iPO4607 RAT OIS 015 115 OIS elS 115 015 015 IIS 015 OIS ilS 015 015 :L:LS OIS 015 IIS eis 015 liS OiS OIS 115 OIS OIS IIS OIS OIS liS 015 e!S IIS 015 OIS iiS OiS elS IIS OIS OIS IIS OiS 015 115 elS OIS -0.02 IP04576 OIS 444.6.-S 467.39 4R-8.64 423.60 362.03 303.06 437.35 443.47 3.66.99 438-21 39e.27 376.27 ' 327.67 ' 3:42. O:L 0 374.19 402. 2E' 380.22 273.08 36-2. 92 ' 397.27 ' 3e7.R-6 ' 373.se , 3e9.60 432.29 378.49 37:L. 02 449.14 373.65 335. :ie 473.46 397.23 35t-,.46 351.13 3@C-.:L5 392.07 432.34 ' 451.63 ' 352.16 ' 354.63 ' 372.4? 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To@:-CINC STLIE,Y OF FPI-29*7'4 & FC-143 IN EXF'.# 0281CROO12 TECHt-JIC@lFit4INITIFILS:S SW TOE)FlkT'"SDATE:S SEX OF RATS:S FEMALE R.CoCit-1I4LIME;EP:S [)-33CI WEIGHT OF FULL FOOD JAR:S 650GRFif'IE- RF4TS WEEl'. 62 iF:04756 IR04757 F,'AT # FOOE)JAR IR04758 IR04759 FOODJRR IR04760 RAT # iRO4761 RFIT # FOODJAR iRC4476@' IR04763 RFIT # FOODJAR IR04764 IR04765 FOODJRR IR04766 IR04767 FOODJAR IR04768 IR04769 FOOE)JAR IR04770 IR0477i FOOC-JAR 045 04S 14S 04S 04S 14S 04S 04S 14S 04S 04S 14S 04S 04S 145 04S 04S 145 04S 04S 145 045 04S 145 3E.3.32 4 0.10 4 IR04757 045 500.45 14 355.27 4 339.54 4 397.37 14 0.12 4 IR04760 04S 0.05 ' 4 IR0476i 04S 0.07 ' 14 284.61 ' 4 0.06 4 IR04763 045 419.34 14 365.25 4 349.46 4 403.98 14 277.74 4 456.73 4 416.29 14 -f68.l7 4 346.82 ' '4 411.38 ' 14 3.35.71 ' 4 347.70 ' 4 402.27 ' 14 o.ie 0.12 ' 0.05 ' 0.06 363.32 0.1 NOT ON 500.45 355.27 339.54 397.37 0.12 NOT ON 10.05 NOT ON 0.07 284.61 0.06 NOT ON 419.34 365.25 349.46 403.98 277.74 456.73 416.29 368.17 346.82 411.38 335.71 347.7 402.27 STUDY STUDY STUDY STUDY IR04772 045 iRO4773 045 FOODJAR 14S IR04774 04S IR04775 045 RAT # 263.27 ' 4 301.45 ' 4 430.29 " 14 401.33 ' 4 0.12 ' 4 iRO4775 04S 0.12 263.27 301.45 430.29 401.33 0.12 NOT ON STUDY FOODJAR 14S IR04776 04S IR04777 04S FOODJAR 14S 509.31 ' 14 293.61 ' 4 429.13 ' 4 409.76 " 14 509.31 293.61. 429.13 409.76 IR04778 045 IR04779 045 RAT # - 351.76 -0.08 IR04779 04S 4 4 -0.08 351.76 -0.08 NOT ON STUDY FOODJAR 14S 516.33 14 516.33 IR04780 04S 0.02 4 0.02 r-%T # IR04780 04S 0.02 NOT ON STUDY -..04781 04S 0.06 4 0.06 14 RAT # FOODJAR 14S iF:C44782 04S IR04781 04S 0.02 0.08 0.06 14 4 NOT ON STUDY e.e2 0.08 F:FIT # IR04782 045 rd.oe NOT ON STUDY IR04783 04S 0.06 4 0.06 RAT # IR04783 04S 0.06 NOT ON STUDY FOOC).JFIP 145 0.07 14 0.07 IP047e4 04S 25E:, el 4 iRA- 4785 0 4'z-. 0. 1 Ci 4 PAT 0 :LFC'4-.@-85 045 FCii--i[-JFiF1'4S IPC,478E. 045 IF'C'4f@61- 04S. Po:iT # DC-JFIF' 14S F.0, 4.7 6 E; 045 5 1-@-._,. -_"I 14 391. 01 4 0. ci9 4 IR04787 04S 518. 01 ' 14 0. 07 ' 4 F;'FTl # IF:Ci478e. 045 IF'.047'89 C,4 E. FCti--i[-JFiP14:E. ---:16. 47 ' 4 5 ciJE..36 14 IPCi479C, 045 414. 97 4 IR0479i 04S 361.22 4 FCIOE)JAF: 14S 440. 34 14 1 P.0 4 7 -c2o 04S IR04793 04S 332. 05 4 e. o e, 4 PAT # IR04793 04S FOODJRR 145 IR04794 04S IR04795 045 FOOE)JAR 145 IR04796 045 IR04797 04S FOODJAR 14S IR04798 045 IR04799 04S FOODJAP 14S IR04800 045 IR04801 045 FOOE)JAR 14S iRO4802 04S IP04803 04S FOODJAR 14S IR04804 04S IR@4805 045 FOCi[.-.jFtF.1,4S IR04806 04S PAT # IR04807 045 FOODJAR 145 IR04808 045 IR04809 04S FOODJAR 14S iRO4810 04S IR0481i 04S FOODJAR 145 IR04812 045 IR04613 04S FOODJAR 145 IR048i4 04S iRO4815 04S FOODJAR 145 IR04816 04S RAT # - iRO4817 045 FOODJAR 14S IR04818 04S it @819 04S FOUDJAR 14S IR04820 045 529.05 ' 14 360.27 ' 4 352.53 ' 4 402.38 ' 14 331D. 30 ' 4 291.76 ' 4 406.05 ' 14 312.52 " 4 375.3e , 4 423.58 ' 14 341.47 ' 4 334.36 ' 4 407.96 14 383.43 4 417.15 4 376.59 14 301.87 4 322.14 4 416. 52 14 0. li 4 IR04806 04S 257. 79 ' 4 558. 37 ' 14 403.14 ' 4 293.74 ' 4 406.59 ' 14 364.96 ' 4 4 400.81 14 355.48 4 329.31 4 390.18 14 330.85 4 423.99 ' 4 404.13 ' 14 0.02 ' 4 lR048i6 04S 566..86 4 485.34 14 397.67 4 256.29 4 424.99 14 335. 48 4 FOODJAR 14 IR04821 05S IR04,c-.22 05S FOOE)JAR 155 IF'04823 055 423.80 5 313. 91 5 383.28 15 445. 54 5 0. io 0.09 0. 07 0.08 0.11 0.02 E:.E:I 0. 1 NOT 014 STUDIT' 31 391. ei 0. 09 NOT ON STUDY 518. 01 0. 07 NOT ON STUDY 47 5CI6. 36 414. 97 361.22 440. 34 332. 05 rd.06 NOT ON STUDY 529.05 360.27 352.53 4e2. 318 330.3 291.76 406.05 312.52 375.3S 423.58 341.47 334.36 407.96 383. 43 417.15 376.59 301.87 322.14 416.52 0.11 NOT ON STUDY 257. 79 558.37 403.14 293.74 406.59 364.96 408.54 400.81 355.48 329.31 390.18 330.85 423.99 404.13 0.02 NOT ON STUDY 566.86 485. 34 3-q7. 67 256.29 424.99 335. 48 524.98 423.8 313. 91 383.28 445.54 40 FCII:Il@ifiFi-5S I F'C'4 h: C15S 1 F,L@4 E;e-_o,@'.05!E. 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O.-@ 15 3 59 5 39C-i. 81 5 390. 46 15 325.90 5 433.08 5 368.58 15 41E.. 81 5 475. 50 5 3 5 -co.C,9 15 --@36.41 5 452.76 5 4 1 -@'.72 15 398. 6cl 5 IP04S44 055 FOOCA JFIP 15S IR04845 05S IR04846 Of-:5 FCiCiE.-JA1P55 IP0484,@ 05S IF'04848 05S FL-,C,C)JFiF:15S IF'04849 05S IP04850 055 FOOC.,JAF, 15S IR$.-@14851 05S IR04852 05S FOOC.*,JAR 155 IR04853 05S IR04854 05S FOODJFIR 155 iR@4855 055 IR04856 055 FOOE)JAR 15S IR04857 05S PFIT # IR04858. 05S FOOE)JRR 155 IRC44859 05S IRLi@4.cj6O 05S - -,O[)JAR 15S -@04861 05S IP04862 055 FOOD-JRR 155 IF:04*61-: 055 IF'04S64 05S Ff--iO[-JFiF1,55 IR04665 055 IF'04866 055 335.08 4 3 2. 8,R 437.12 54E.. 6 ri -@7 4. --1:2 3 4 #---1.4 406. C,7 318.00 433. 64 384.04 368. 32 429.09 500.51 342.38 431. Opc 338.61 ' 389.68 ' 430.70 ' 366. 7t- 416. 28 -0.03 IR04657 05S 326.45 534.26 338. 04 505.44 3162. 82 375. 77 431. 92 415. 8--425.03 42:@,.74 370. 86 4C,4. 90 4 6 -@'.60 5 15 5 5 15 5 5 15 5 5 15 5 5 15 -% 5 15 5 5 15 5 -0.03 5 15 5 5 15 5 5 15 5 5 15 5 5 517. 5'--@ 349. t-4 411. 310. 09 390. 47 351. 73 5E.8. 7 357. 91 447. r-II 4:4,9.74 391. --,4. 418. 76 469. 45 391. 2--l' 380. 9.3 397. 83 406. 03 383. 59 390. 81 390. 46 325.9 433.roe 368.58 416.81 475. 5 359. 09 336.41 452.76 4 72 398. 6 335.08 432. 88 437.12 548. 6 374. 32 341---,1.4 4 0 07 318 433. 64 384.04 368.32 429.09 500.51 342.38 431.06 338.61 369.68 430.7 -k66.75 416.28 -0.03 NOT ON STUDY 326.45 534. 2 E. 33e..04 505.44 362.82 375. 77 431. 92 415.86 425. 03 423. 74 370. SiE. 404.9 462.6 4j:) -1F: F OC,llIFIF, I F -C,4: C455 1 F'C,4 C' -jFlF'155 1 F'C.41 ClE.S F.t--4,E.7 El 1 F.ri4 7 4 0 FCir_ic,.jRF'1.65 lF'Cl4S,-"@05 1 F".0 4 E:.-IE. 0 i_s-FOf--IEAJAF' IE-Si R 1--1P4;7 7 ElC%S IPC'4e.78 OE-S FOOE.,JFIR 165 IPC'4879 06S :LF:C'4880 OIE-5FOOE,.JFIF,'I P-S-, IF.'.I@14E.elGE-S 1 F.C'4'=-'B.*-@-'ElIESFOOE@.JFiF' 16!EIP04*81 06S IR04884 065 FOCIE.-.JAF'.165 lPr!48*5 06S IR04886 Cl6EF't--!CiC@JFiR16S. I P 0 4 :'S@ -.7 OES IF'C44*:38 065 FFjCl[,.JFIFI' i-S-. fj IF-04890 06S FCICILI.JfiF'I.r--. IF:C,4*91 0 ?-E--- 065 FCIOIjJFiF: ILLS IR04893 065 IPC,4894 Ci6S FOOD JRF' IPZEIF.'.C'4895065 :IF'.C'469606S- FOOE).JRR :L6S IP.04897 OES IP0489E: 065 FOOD-JAR 16S iRO4899 06S IR04900 065 Fl--Ir-ll'JRiP6S IR04901' 065 RAT IR04902 065 F: ',.jFiRi6S lPu490--,' 06S iRO4904 065 FCiCi[@JFiF: liE.5 IR04:?05 065 IR04906 065 FCIOE, iRF: 1 IP04907 0 P-1I- . E - 5 (-Ci. 4:i: 5 4rit-15 15 6 C, !!. 4 PE, 5 37C'. --'I 15 4.-,5.19 E. 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E.3 41Z'.95 567. 9 354. 11 66 3@E.. 77 42C,.68 398. 03 4 --7<. 29 370. :13 3813. 7E. 402. 74 3 _q-@"5.9 472. 1 528. 41 359. 09 441.47 328.76 3-qS.54 441.68 514. :1 Z@ 404. :16 5:15. 24 474. 28 354 i-78.52 4oE.91.2 337. 35 425. 48 56-E..02 340. 17 411. 18 388 4 C"-4.7 451--16.4 417. 8 -Q 375.57 385.77 42:1.Si 3:18. 8", 392.12 302.90 400.32 -0.06 140T 014 STUDY 414. 66 507. 05 378. 73 396. :L5 397. 93 364. :41 360. 3 39E".09 453.39 1400 IF -@l4 Fi--ii--i[-.JFiIF: E'ci 4E:-. 8t. 06'-. FC"-'L: IF' i-:I;I El 5 11 4 9 C,E.'-z 5 1 F.C,4.:-#1 @;@ OES IP.C@14?14 06S F 0 1--C1@-J FiF,' i6S IF.'.C'49150 0-E---- OE-5 FOOC)JRP 165 IF,04917 06S IR0491E; 065 FCiCiE.-.JFiF, IF:04919 OES F:FIT 1,E. 44!!-. '.f@@' - 150 " 5 1. C4'-; " 51-11.IE.'4 ' 457-@ . 10 -4:47.22 494. 24 481. 49 318. 21 472. 68 481. 53 354.83 448.84 332. 34 3!!-E..4 Z,' 3 5 --<5.1 -0. Ci :LF:C,49'-7'00 515. 7@- E. IE. E. E. 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C4--< 35---,.2 442. 45 279. 71 410. 49 4CI. 24 409. 32 544. 18 0 NOT Of4 492. 01 -0.02 NOT 014 STUDY STUDY 14.-D TWC, YEAP: ORPL(DIET) TC)X-Ot4C STUDY OF FM-3924 & EXP.0 TECHNICIAN INITIALS:S SW TODAY'S DATE:S 9110,18@' SEX OF RRTS:S FEMALE ROOM NUMBER:S D-330 WEIGHT OF FULL FOOD JAR:S 650GRAMS FC-143 IN 028iCROO12 RATS WEEV.,* 70 IR04756 045 4 377.68 IR04757 045 RAT # FOOE)JAR 14S IR04758 04S IR04759 04S FOODJAR 145 IR04760 RAT # IR04761 RAT # FOOE:,JAR IR04762 iRO4763 RAT # FOCIDJAR IR04764 IR04765 FOOE)JRR IR04766 IR04767 FOODJAR IR04768 IR04769 FOOE)JAR IR04770 IR04771 FOOE)JAR iRO4772 IR04773 FOODJAR IR04774 iRO4775 RAT # FOODJAR IR04776 IR04777 FOODJAK IR04778 IR04779 1T# t-,jODJRR IR0478o RAT # IR04781 RAT # FOOE)JAR IR@4782 RFIT 0 045 04S 145 04S 04S 145 045 04S 14S 045 04S 14S 045 045 14S 04S 045 14S 04S 045 14S 045 045 145 04S 04S 14S 04S 04S 14S e4S 045 14S 04S -o.oci IRe4,5,' 045 517.08 369.91 361.35 350.85 o.oc, iRO4760 04S 0.00 IR04761 04S -0.03 302.81 ' 0.01 e iRO4763 04S 501.18 ' 379.4-'o ' 376.61 ' 382. 87 e 46-5.85 ' 407.16 ' 399.25 e 361. 19 375.98 351.50 373.81 392.71 277.26 302.75 ' 41:L. 61 ' 428.60 e 0.10 ' IR04775 04S 497.86 e 293.56 ' 462.12 ' 401.49 ' 354.60 ' 0.04 ' IR04779 04S 517.82 ' 0.08 IR04780 04S 0.06 lRe4781 04S 0.07 0.05 IR04782 04S 4 -0.00 14 4 4 :14 4 0.06 4 0.00 14 4 4 0.01 14 4 4 14 4 4 14 4 4 14 4 4 14 4 4 14 4 4 e.io 14 4 4 :L4 4 4 0.04 14 4 0. 08 4 0.06 14 4 0.05 0 NOT ON 517.08 369.91 361.35 350.85 STUDY O.OE. NOT ON STUDY 0 NOT ON STUDY -0.03 302.r:si 0.01 NOT ON STUDY 501.18 379.49 376.61 382.87 285.99 465.85 407.:L6 399.25 36:L. :L _q 375.98 351.5 373.lBi 392.71 277.26 302.75 41:L. 61 428.6 0.1 NOT ON STUDY 497.86 293.56 462.:L2 4el.49 354.6 0.04 NOT ON STUDY 517.82 o.e8 NOT ON STUDY 0.06 NOT ON STUDY 0.07 0.05 NOT ON STUDY 4DD IP0478a 045 RAT 0 FOCIDJRR 14S IF:041-84 045 IR04785 04S RAT # F-'ODJAR 14S . 44786 04S IR04787 045 RFIT # FOODJAF' 14S iPL-'47SE: 045 RAT # IR04789 045 FOODJAR 14S IR04790 04S IR04791 04S Fe.FiT# FOODJAR 14S ,>04792 045 IR04793 04S RAT # FoCiDJAR 14S IR04794 045 IR04795 04S FOODJAR 14S IR04796 04S IR@4797 04S FOODJRR 14S IR047ge e4S IR04799 04S RF17 # FOODJAR 14S iRO4800 04S IF-04801 04S FOODJAR 14S IR04802 04S IR04603 045 FOODJAR 145 IR04804 04S IR@4805 04S FOODJAR iRO4806 045 RAT # IR04eO7 04S FOODJAR 145 IR04808 IR04909 FOODJAR IR04810 iRO48ii FOODJAR IR04812 IR04813 FOODJAR iRO48i4 l@g48i5 1 JDJAR 04S 04S 145 04S 04S 14S 045 04S 14S 04S 04S 1.4S lR048i6 04S RAT # IR@4817 04S FOODJAR 145 IR04elB 04S IR04819 04S 0.05 4 IR04781 045 0. ri6 14 266,37 4 ra.04 4 IR04785 045 533.42 14 40-ci-82 4 0.03 4 IR04787 04S 503. 93 ' 14 0.07 ' 4 IR@4788 04S 377.28 ' 4 492.ei e 14 426.98 ' 4 0.03 ' 4 IR0479i 045 5'37.10 ' 14 330.14 ' 4 0.12 ' 4 IR04793 045 526.41 e 14 368.99 4 358.57 4 386.27 14 327.87 4 298.58 4 416.81 14 320.01 4 0.08 4 IR04799 045 516.28 14 334.21 4 354.49 4 414.53 14 409.96 4 423.60 4 368.38 :14 299.19 ' .4 335.79 ' 4 14 0.02 ' 4 iRO4806 04S 263.66 ' 4 524.55 ' :L4 413.00 ' 4 295.:16 ' 4 399.6:1 ' :L4 368.75 ' 4 417.11 ' 4 387.79 ' :14 366.42 ' 4 343.9:1 ' 4 390.54 ' :14 344.32 ' 4 399.77 ' 4 386-39 ' :14 0.02 ' 4 :LR048:L6 04S 585.54 ' 4 490.80 ' :14 405.12 ' 4 26:L.97 ' 4 0.05 ' 0.04 ' 0.03 0.07 0.03 ' 0.12 ' 0.08 0.02 0.02 0.05 NOT ON STUDY 0. OE. 266.37 0.04 NOT 0?4 STUDY 533.42 409-82 0.03 NOT ON STUDY 503. -c)3 0.07 NOT ON STUDY 377.28 492.81 426.98 0.03 NOT ON 507.1 330.14 0.12 NOT ON 526.41 366.99 358.57 386.27 327.87 299.58 416-81 320.01 0.08 NOT ON 5:L6:28 334.21 354.49 414.53 STUDY STUDY STUDY 409.96 423.8 368.38 2-q9.i9 335.79 402.96 0.02 NOT ON 263.66 524.55 STUDY 413 295.16 399.6:1 368.75 417.11 397.79 366.42 343.91 390.54 344.32 399.77 386.39 O.e2 NOT ON 585.54 490.8 405.1.2 STUDY 4D 4 FOODJRR 14s 21. 14 413. iRO'4820 045 6. 19 4 326. 19 FOODJAR 14 416.24 iRO4821 055 397.13 5 311.24 5 397.13 31:1. 24 398.76 I-RO48-2 05S FOOE)JAR 155 398.76 15 479.73 IRL14823 055 t 14824 055 479.73 5 527.22 ' 5 527.23 puoDJAR 15S 356.90 ' 15 4 -@>-@'.5 F-: ' 5 356.9 422.56 316.71 IR04825 055 JR04826 055 316.71 ' 5 395.31 FOOE)JAR 155 395.31 ' 15 5 354.03 iRO4627 055 IR04828 05S 354.03 ' 604.39 ' 5 604.39 FOODJAR 155 354.03 ' :L5 444.57 ' 5 354.03 444.57 iRO4829 055 IR04830 05S 453.97 ' 5 453.97 FOODJAR 15S 375.27 " J.5 4213.19 5 375.27 420-:19 IR0483i 055 IR04832 05S 485.42 5 41B5.42 FOODJRR 155 353.14 15 449.62 5 353.:L4 449.62 IR04833 05S IR04834 055 399.7:L 5 399.7:1 FOODJAR 155 371..107 ' :15 379.36 ' 5 37:1. 07 379.36 IR04835 055 IR04636 055 38t.35 5 381.35 FOODJAR 155 IR048--@.7 05S 340.93 15 333.74 5 340.93 333.74 iRO4838 05S 462.38 5 337.34 :15 462-38 337.34 429.64 FOOE)JAR 155 iRO4839 055 429.64 5 iRO4940 055 493.63 5 342.37 :15 493.63 342.37 FOODJAR 15S IR04841 05S 366.09 5 366.09 IR04842 055 46:1.-c4l 5 365.81 15 46:L. 94 365.Si FOODJAR 15S iRO4843 055 404.02 .5 404.02 IR04844 055 334.02 5 377.39 15 334.02 377.39 464.81 FOOE)JAR 155 IR04845 05S 464.8:L 5 iRO4846 05S FOODJAR 155 542.97 ' 5 329.43 ' 15 542.97 329.43 337.49 iR@4847 05S 337.49 ' 5 0.02 ' 5 0.02 NOT ON STUDY IR0484s e5S RAT # IR04848 055 0.02 15 450-35 FOODJRR 15S iRO4949 05S 450.35 ' 442.77 ' 5 5 442.77 382.58 IR04850 05S FOODJAR 15S 382.58 ' 356.69 15 448.10 5 356.69 448.:L IR04851 055 IR04852 05S 523.33 5 523.33 FOODJAR 155 325.01 15 434.:15 5 325.01 434.15 IR04853 05S iRO4854 e5S 342.40 5 342.4 FOODJA@ 15S 388.42 15 441.:13 5 388.42 441.13 IR04855 05S IR04856 05S 380.37 5 380.37 FOODJAR 15S 358.89 15 358.89 14857 05S 0.01 5 k.iT # IR04857 05S 0.01 0.01 NOT ON STUDY IR04e58 05S 355.10 5 355.1 .7r- FOODJAR 15S 513.86 15 5:13. 86 IR04859 05S 323.85 5 323.85 IR04860 055 6is. 11 5 6ie. :Li FDODJAR 15S 3:16.01 :15 357.75 5 316. O:L 357.75 IR04861 05S at AAC CAW *KC AAC CC% 0 FOODJAR 15S IR0486a 05S IR04864 05S FOODJAR 15S IR04865 055 IR04866 055 FNODJAR i5S 4@4867 055 IR04866 05S FOODJAR 15S IR04669 05S iRO4870 05S FOODJAR 155 IR0487i 065 IR04872 065 FOODJAR 16S iRO4873 06S IR04874 06S FOODJAR 165 IR04875 OES :LR04876 06S FOODJAR 16S iRO4877 065 iRO4878 06S FOODJAR i6S IR04879 06S IR04880 065 FOODJAR 16S IR0488i 06S IR04882 065 FOODJAR 16S iRO4863 06S IR04884 06S FOODJAR 16S iRO4885 06S IR04886 06S FOODJAR 16S IR04687 065 iRO4888 06S FOODJAR 16S iRO4889 065 IR04890 065 FOODJAR 16S iRO489i 06S IR04892 065 FOODJAR 16S IR04893 06S IR04894 065 FOODJAR 165 tRe4895 06S IR04896 06S FOODJAR 165 IR04897 06S IR04898-06S FOODJAR 16S IR04899 06S iRO4900 06S F^QDJAR 165 349ei 06S RAT # IR04902 06S FOODJAR 165 IR04903 065 IRE-A904 06S FOODJAR 16S 4.14.08 ' 436.27 ' 433.83 ' 348.1.2 ' 409.56 " 47.1. 56 ' 351.52 ' 378.70 ' 377.7C' " 376.71 ' 469.47 ' 395.30 ' 355.0:1 ' 5LA0.27 ' 330.82 ' 369.18 416..24 595 20 370.36 388-89 395.45 387.97 432.96 ' 444. :L:L' 33J.. 92 ' 392.88 ' 419.64 ' 360.8:L ' 469.96 ' 537.77 ' 356.57 ' 482.16 ' 331.82 ' 372.90 ' 470.68 ' 5:L2. 31 369.95 516.01 479.68 344.01 387.94 471.91 355.05 ' 451.59 ' 562.98 ' 352.97 ' 433.82 ' 390.82 ' 403.49 ' 463.94 ' 386.03 ' 386.21 ' 431.76 ' 448.85 ' 358.20 ' 388-94 305.19 404.e5 -0.01 IR0490i 06S 436.73 ' 506-03 ' 384.52 ' 411. 91 ' 379.75 ' 15 5 5 15 5 5 15 5 5 15 5 5 1.5 6 6 :L6 6 6 16 6 6 :L6 6 6 1.6 6 6 16 6 6 16 6 6 16 6 6 :L6 6 6 16 6 6 16 6 6 16 6 6 16 6 6 16 6 6 16 6 6 16 6 6 16 6 6 16 -0.01 414. OE: 436.27 433.83 348.12 409.56 471. 56 351.52 378.7 377.7 376.71 469.47 395.3 355.01 500-27 330.82 369.18 4:16.24 595.2 370.36 388.89 395.45 387.97 432.96 444. :Ll 33:L. 92 392.88 419.64 360.Si 469.96 537.77 356.57 482.16 33:L.82 372.9 470.61B 5:12. 31 369.e5 516.ei 479.68 344.01 387.94 471.91 355.05 451.59 562.98 352.97 433.82 390.82 403.49 463.94 386.03 386.2:1 431.76 448.85 358.2 388.94 305.19 404.85 -0.01 NOT ON STUDY 436.73 506.03 384.52 411.91 379.75 IR04905 065 IR04906 065 FCjOE:-JFiF, i6S IR04907 065 IF<04908 065 RAT # FOODJAR 165 @ )4909 06S lm04910 06S FOO[)JAF: 165 IR04911 06S iRO4912 06S FOOE)JAR 16S IR04913 OES IR04914 06S FOOE>JAR 165 IR04915 065 IR04916 06S FOODJAR 165 IR04917 065 IR04918 065 FOODJAR i6S IR04919 065 IR04920 06S RAT # FOCIDJRR i6S 9999999999 352.5C, ' 317.38 ' 426. 34 ' -0.03 IR04908 06S 482.74 448.18 41l.88 346.45 519.39 491.54 362.08 530.76 511.79 309.57 484.65 ' 508.01 ' 382.89 ' 464.66 ' 342.58 ' 362.72 ' 382.69 ' -0.06 IR04920 06S 512.02 99 6 6 16, 6 6 -0.03 is 6 6 16 6 6 16 6 6 16 6 6 16 6 6 16 6 6 -0.06 16 0 35@'.5 317.38 426.34 467.03 -0.03 NOT Ot4 STUDY 482.74 448.18 411.88 346.45 519.39 491.54 362.08 530.76 511.79 309.57 484.65 508.01 3r::2.89 464.66 342.58 362.72 382.69 -0.06 NOT ON STUDY 512.02 4 -.D7 'T'ERF'CIF.:FIL-.[-IEI 1C'::'-OtJC STLIC',',OtF' FC-14.-@ lt4 F'@ITS TEI-:Ht4IC:lFitl4t4ITIFiLS:S TCoC-FI'T'* '-[:@F7ITE:5 SE:--:CIF RAT-C:S FET-IFILE RCiCit-IfJLII-IE:EF5:: [:----<4C', t.IEII:iH7OF FULL FOOD JFIF::S 65Cl:iF.,Fit-IS 14EE@.:'72 1 F:F-4i 5 7 015 F'FIi # IF'C'457i@ CIIS ci.ci I F','-7-1-4 E. 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C4 ci IR0464C4 OIS 1 I 0. cici 11 1 1 0. ci2 li I -0. oci 492 94 ci t4OT ON 484. 17 6orS. 75 0. C,12 NOT ON 474, 9 ci NOT Ot4 STUCAT' STUE)Y STU[)Y '/7 TW,--@l'EFiF:CiF,:FiL(EilETT,O,:-:-Ot4SCTUDY OF Fl-l-.-@9-&@1F4C.-:14-1-1,4RFiT.I@@ EX'P. 028:ICROOI.2 TECHNIC:IAN INITIFILS:S S@4 TODAY'S DRTE:S 12/17/82 SEX OF RATS:S FEMALE ROOM NUMBER:S D-330 WEIGHT OF FULL FOOI:@ 'WEE@:: 84 IP04756 045 RFIT # IR04757 04S RAT # 0.00 IR04756 04S -0.06 IR04757 04S 4 0.00 4 -0.06 FOODJRR 145 IR04758 04S IR04759 04S 0.01 14 393.15 4 398.06 4 FOODJAR 14S 395.10 14 IR@4760 04S RAT 0 -0.02 IR04760 045 4 -0.02 IR@4761 04S 0.02 ' 4 F,I'Tf # IR04761 04S 0. 02 FOODJAR 145 0.04 ' 14 iRO4762 04S IF:0476@- 04S F:FIT # 312.75 ' 4 0.09 4 IR@4'.763 C44S 0. 09 FC,C,E-JAF: i 4,-@. IP04764 04S IR04-.@'65 04S 5Z'O. 35 14 384.34 4 416.67 4 FCiCi[)JFl1F4,5* 4:17. @-;7 14 IR04f'66 04S iRO4767 04S 288.54 4 490.26, 4 FC,Ci[@JFIF;'14S 3-c07. 18 14 IR04768 045 iRG476@Q fb4S 43E..43 4 3@)@3.29 4 FC,Cll.,JAR 14S -33. 71 14 IR04770 04S 364. 5 E. 4 IF:0477i 045 FCoCil)JRR. 14S iRO4772 04S 42-@. 87 ' 4 395. 10 " 14 294.33 ' 4 IF*047"1'3 045 314. Z@-6' 4 FOOE)JAR 14S 401. 31 ' 14 iRO4774 04S 444.20 ' 4 IR04775 04S 0.10 4 RAT # IR04775 04S 0.10 FOODJAR 145 517.10 14 IR04776 04S 324.71 4 iRO4777 04S e.ei 4 RAT 0 FOODJAR 14S IR04777 045 512.28 0.01 14 IR04778 04S 373.08 4 IR04779 04S 0. i:l 4 RAT IR04779 04S e.ii FOODJRR 145 5e6.70 14 l@'04780 04S 0.03 4 ( -0 iRO47se e4S 0.03 IR04781 04S RAT 0 0.02 iRO478i 045 4 0.02 FOODJRR 14S 0.05 14 IR04782 045 0.05 4 RAT # iRO4782 04S 0.05 IR04782 045 0.06 4 0 NCIT 014 STUDY -0.06 NOT ON STUDY 0.01 393.15 398.06 395.1 -0.02 NOT ON STUDY 0.02 NOT ON STUDY 0.04 312.75 0.09 NOT ON STUDY 520.35 384.34 416. 67 417. 57 288.54 49O.3E. 397. 1 e. 436.4--< 3:,:@:.29 333. 71 364. 5 iE. 42 87 395. 1 294.33 314.56. 401. 751 444.c).' 0.1 NOT ON STUDY 517.1 324.71 0.01 NOT ON STUDY 512. 2E: 373.08 0. :li NOT ON STUDY 50tB.7 0.03 NOT ON STUDY 0.02 NOT ON STUDY 0.05 0.05 NOT ON STUDY 0.06 4oo F'FlI FCIC,E@JFiF: 145 i 1;,C44 7 e 4 C44 IF:C,4-1@'E:5Ci4 P.I@T # FOODJFIR 14S 34786 C,45- ite.Ci4787 045 RFIT 0 FOOC).JFIF' 145 IR04788 04S RFIT 0 IR04789 04S FCOOE.-JAR 14S IR04790 04S RFIT # IR04791 045 RFIT # FOODJAR 145 IR04792 04S IR04793 04S RFIT # FOODJRP 145 iRO4794 045 IR04795 04S FOODJAR 14S IR04796 IR04797 045 04c- FOODJAR 14S IF*C,4i-9E: C-14S IF'04799 04S RFIT # FOODJAR 14S IF'04800 04S IR04801 04S FOODJAR 14S iRO4802 045 IR04803 04S FOODJAR 14S IR04804 045 IR04805 04S FOODJAR 145 IF:04806 045 F'F.lT # IR04807 04S RFIT # FOOE)JAR 145 IR04808 04S IR04809 04S FOODJAR 145 IR04810 045 iRO481i 04S FOOE>JAR 14S IR04812 04S IR@4813 04S FOODJAR 14S iRO49i4 04S 'RB48i5 04S FOODJRR 14S IR04816 04S PAT # IR04617 045 POODJAR 14S IR04818 045 tRe@4819 04S FOODJAR 14S IF:04 Ile-!.045 C, C,51 2@:2. 2.2 ro. 04 I FeC.'4 7 C,5 045 535.86 438. 79 -0. 03 iRO4787 04S 518. 73 0.02 IR04788 04S 402.39 487.72 0.03 iRD4790 045 -0.03. iRO4791 04S -0.07 322.73 -0-00 iRO47.93 045 530.77 399.62 37C,.21 40:1.62 384.10 364.83 394.21 32 C'.t,7 0. ci6 IR04799 045 5.-@@1.69 ' 39-0.5 C, ' 410.70 ' 402.36 ' 432. 06 ' 452.74 ' 37e..Ie. ' 284.22 ' 303.91 ' 472.73 ' -0. 07 iRO4806 04S -0.06 IR04807 045 -0.00 476.85 ' 308.44 ' 399.95 ' 390.43 ' 438.11 ' 389.47 ' 430.87 ' 39-t.58 373.89 334.01 406.14 402.70 0.12 ' IRD4816 04S 678.72 ' 469.01 ' 464.36 ' 274.12 ' 415.29 ' 0. CiE. , NOT OtJ STUE)ITI 14 0. 05 4 28r--'.82 4 0. 04 0. 04 ' NOT ON STUD'r' 14 535.SE. 4 438.79 4 -0.03 -0-03 NOT ON STUDY 14 51B. 73 4 e.e2 NOT ON STUDY 4 402.39 14 487.72 4 0.03 0.03 NOT ON STUDY 4 -0.03 -0.03 NOT ON STUDY 14 -0.07 4 322.73 4 0 -0.00 NOT ON STUDY 14 530.77 4 399.62 4 37Ci.21 14 401.62 4 364.1 4 364.83 14 394.21 4 327.57 4 0.06 0.06 NOT ON STUDY' 14 531.69 4 360. 5 4 410.7 14 402.36 4 432. 06 4 452.74 14 376.18 4 284.22 4 303.91 14 472.73 4 -0.07 -Ci.07 NOT ON STUDY 4 -0.06 -0.06 NOT ON STUDY 14 0 4 476.85 4 308.44 14 399.95 4 390.43 4 438.11 14 389.47 4 430.87 4 39--<.58 14 373.89 4 334.01 4 406.14 14 402.7 4 0.12 0.12 NOT ON STUDY 4 678.72 14 469.01 4 464.36 4 274.12 14 415.29 4L) IR,04820 04S RFIT # FOODJAR I P 0 4 8 055 PAT # 055 c'DOL-JFiF: :155 ,R@48f'-3 055 IF'04824 055 FCiCiDJFiF,* :15S IR04825 055 IR04826 055 FOCIE@JAR 15E> IF..'04S27 05S IR04828 055 FOODJAR 15S IR04829 055 iRO4830 05S FOOE)JAR 155 IR04S31 055 IR04E:32 05S FOOC@JAF' 15S IF-04e-l @-@: o5s IR04834 05S FOODJRR 155 IR04e35 055 iPO4S36 055 FOOE,-JAP 15S 1 F @C,4 @@,7 05S 1 F:0 4 3=-.' 05S FC,,--t[)JFt1F'5,-@ IR048-@.9 05S IF-04840 05S FOOI)JAR 155 IR04841 05'-@ IR04842 FOODJAF: IF:04843 PAT # IR04844 FCIODJAR IR04845 F:FIT # IR04846 RAT # FOODJAR IR04847 IR04848 RAT # FOODJAR iRO4849 IR04850 FOODJAR IR04851 iRO4852 FOODJAF,' @t-104e53 34854 FOODJAR iRO4855 IR04856 FOODJRR IR04e57 RAT 05S 155 055 05S 158 055 05S 15S 05S 05S 15S 05S 05S 15S 05S 05S 15-c@ 05S 055 155 055 05S 15S 05S Cl. ci5 IR048 04S -0. 11 iRO4821 05S 317.29 523. 6 E-: 511.. 15 547.98 340. 4F, 427.92 339.13 379. 06 371.83 637.63 375.45 448.09 46:1.59 398.54 ' 351.29 ' 509.62 ' 385. 31 ' 628. 13 ' 420.18 ' 325.62 ' 412.22 " 414.08 ' 385.47 ' 329. 79 " 4 --2<. 14 ' 39Z. 94 ' 474.05 ' 49L;.78 ' 338.24 " 379.10 ' 525.71 ' 366.66 ' -0. 0? IR04843 05S 343.01 443. 5C, 0.00 IF<04845 055 -0.06 IR04846 05S e.ei 366.75 0.07 IR04848 055 350.28 468.26 428.31 ' 378.47 ' 328. 23 ' 441. 95 ' 353.02 ' 441.27 ' 495.63 ' 416.53 ' 394.12 ' 0.04 ' IR04857 05S 4 - El.ci-- 14 5 -0.11 5 15 5 5 15 5 5 15 5 5 15 5 5 15 5 5 :15 5 5 15 5 5 15 5 5 15 5 5 15 5 5 15 5 -0.09 5 15 5 0. 00 5 -0.06 15 5 5 0.07 15 5 5 15 5 5 15 t.* 5 15 5 5 15 5 0.04 Ot. NOT Otl STUC)'T' 0.00 -0. 11 NOT ON 317.29 52:i. 68 511. 15 547.98 340. 46 427.92 339.13 379. 06 371.83 637.63 375.45 448.09 461.59 398.54 351.29 509.62 385. 31 61-18.13 420.18 325.82 412.23 414.08 385.47 329. 79 4->2. 14 393.94 474.05 496.78 33e..24 379.1 STUDY 525.71 366.66 -0. 0-9 NOT ON 343.01 443.5 0 NOT ON -0.06 NOT ON 0.01 366.75 0.07 NOT ON 350.28 468.2E. 428.31 378.47 496.43 567.54 328.23 441. 95 353.02 441.27 495.63 416.53 394.12 0.04 NOT ON STUDT' STUD'r' STUDY STUDY STUDY 40 IF'04852 05S FCIO['-JFiF,155 IF:r-14859 0 5 IF'C'48L;O 0 5 F.F'i.T # FOOC@JAR 155 )48E.1 05S IR04862 055 FC101.JAF, 155 IR0486a 05S IR04864 05S FOODJAR 15S IR04865 05S IR04866 055 FOODJAR 15S IR04867 05S IR04868 FOODJAF' 05-c 155 IR.04869 055 IR04670 05S FOOE)JAR 155 IR04871 065 RAT # IR04872 06S FOOC@JAF: i6S IR04873 065 1R04874 FOODJAR 1R04875 1R04876 FOODJAR 1R04877 1R04878 FOODJAR 1R04879 1R04880 FOODJAR IR04881 1R04882 FOODJAR 1R04883 IR@4884 Ot3S FOOE).JFIP 16S IRA-4885 06S IR04886 06S FOODJAR 16S IR04887 065 iRO4888 06S RAT # FOODJRR 16S IR04889 06S IR@4890 06S FOODJAR 16S IR04891 e6S . 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FC,OL,jFlF-,I E.,-= 4CI2. - .- -' E. 5 2 --@.E-5 IE. 41:1.2. 7'@' 5 2.-s.E-5 5 7I 16 t.0-17 -inisr-4lil--jin L3 XI.L .1@(3nis t4o :71@.'10 i,elnl,- NO ION ,'.elniSt-in-i,DN TO '0 ?40 ilDtA T l@l'0 t-4'D il--]N til L'Dti ,-zTl '7 9 :7Ci 98 ,,,,jnit,--4;0 iON I,-jN ci- TO '0 t-40IlDti T t-@l*0 T6 .,,.,inti-4s13iCN T t-Z? ,,,i(sitniidiiD@4 .1)(Iltlliis)icit-4 0 ].,DtJ T @4 T T TO '0 T TO '0 T 71,3 Ci- T .74 T .74 ci- '74 T T :70 '0- '_74 T T0 9T !;o *0 T '?T r4T t3 @t -?T L..i p@ P..-5 ?06tO:tlT CIO It-i ci -@6 CIO 113lt7i- @;*ZiIE 170 '0 sl@40 706to@IT S90 T06tO'.@IT T Ll 'k3 17 k..l'0 006t-o:@IT TCJ 'Ci t-cl:T@j T t-A- 5?0 to,@IT 1-0"Ci- T t-ClT T H C,]I--1-1-1 1 1:.4::l T T s9t3 T .@H # ik tc'6 @-0:1 @-@C,6 1-@l;tiT :@Hf S90 I L4:!i T @-#-Sit- T -;,TP :@k4f-,],--,OA I k4:A S?O tollT T ;:@I@i4'- I A IL4,d -:77,L,)- ;:::-:::'tCi-tiT T :@Hf -31:11-IJ t-Ci::Ti l@4 ::I .74T t7i :4 PL It L L4.ti 'T E: S90 T E Ll 'Cl::.!';@lpt- t-Ci:tTl tp T L7, 'C' ,S i-kl:tTl TO *0 E90 T '7:-t;.,Li;@Tl L3 '@l '3 :Tt- 'T.@L t@ T L3 Ci::::3 t, T L) @i L7@tt) 6 -70 t-L-1 Ci S,-@T -74Ci T t -tTi L 1:1.:@ T. i-,c-".,@iT P-4f C, C, A -L@-4:tl T t7 Cl:tiT @4 f el 1--i # iH.:@ C,'@Tl t-Ci:tTi T t3 t c--i3T T .@$-4f -,:-T4 -7 4ci . zT 17':4 T @P4 f -]I-I-A T:--::::t-t7l.T:i :@@4 C I J ti .7.':4 L@ T @Hf -11-1-1 @l '-, ':- I-L7, T - - -'':-L:' -4r F@.HT C" F:Hl 4t C,4 11 Cl ":AT j-F@i7-l4 I -@' Clt@ F:FIT FCICIE-.jFiF;I:tF,'7 F: 4 L C,E. F'FlT # Ci4'@z1@,E. 0 6 1 FCIC'E,iFiF-'I t@ iPO4 Ql':'01:@ I F:C,41-:-4.o-il ciFE. F'FlT ---------- 5 04 0 - ci.C,C, 01-75 ElI " 0. ciCA OIE-S 0. ci:i F.0.'4'-:1,2 065 Cl. 0 1;71 ciC-.i OES 6 4I1 46-f@. ci. C' S 5 454. 09 4 E..2 C, C,5 5 ;RE4 -i1 ciI IF:0492C' RJC.S c Cl.ci:l - cl. ci r@ o. CiC, E. Cl. 01 Cl. ciC4 -r;i.C12 ci.ClI ci 47E..57 cl.c NOI CitiSTLIL.,'T' El NDT ON STIJE,'T' Cl.ciI ci P40T ON STUE,@' 0. ciI NOT Ot4 STUE)Y ci NOT Cl@4 STljl,y 636. 41 T-IOT ON 6.71. -@@5 454. C, 4 E.E..2 32E.. Ot STLIC)'T@ 4 0. Cil NOT Cit-ASTIJE@',r' 5 --@E'.. fzl-..@ 51-77 1 StephenDistneDr.,VM. 685 Roma Avenue Rose,Allem,innesoto 55113 r,- a/ci-zC>C)l 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 ex- pected 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, @ip?)@QA Z ,s+.n Stephen Bistner DVM Associate professor n@L Comp. Ophthal. 7 APPENDIX ITEM G Two Year Oral (Diet) Toxicity-OncogenicityStudy Of Fluorocarbon FM-3924 In Rats Individual Opththlmologic Findings FEMALES Animal No. Eye Comment(s) Control *lR-4583 S*lR-4584 S*lR-4599 S*lR-4602 *IR-4616 *IR-4620 S IR-4623 S IR-4625 *IR-4636 100 Dom IR-4756 IR-4768 *lR-4776 S 1R-4795 IR-4810 *IR-4811 *lR-4814 30 pom *lR-4822 *lR-4832 *IR-4836 *lR-4838 10 PI)M *lR-4901 *IR-4917 Left Left Right Right Left Right Right Right Bilateral Left Atrophy@ Diffuse corneal opacity Chronic superficialkeratitis Corneal opacity-diffusedulcerated (SDA) Focal iris staphyloma;corneal opacity (chronic uveitis with secondary exophthalmia) Dacryadanitis AtrophyCorneal opacity, enlarged, ulcerated, partiallycollapsed (SDA) Iris staphyloma, focal corneal opacity, ulceration Posterior subcapsular cataract Left Right Right Left Right Left Right Atrophy@ Ocular 2pacityaAtrophyPosterior subcapsular cataract Posterior subcapsular cataract Chronic uveitis Phthisis bulbi (secondaryto bleeding) Right Right Right Right Phthisisbulbi (atrophy) Phthisisbulbi (atrophy) Diffuselens opacity with iritis Phthisisbulbi (atrophy) Right Right Diffuse corneal opacity with pannas Atrophy@ NOTES: indicates blood sampling taken from eyes. indicates animal had possible SDA viral involvement. indicates clinical observation sign. 7 APPENDIX ITEM G Two Year Oral (Diet) Toxicity-OncogenicityStudy Of Fluorocarbon FM-3924 In Rats Individual Opthalmological Findings MALES Animal No. Eye Comment(s) Control *lR-3531 *IR-3534 S*lR-3539 *lR-3548 *lR-3562 *IR-3565 S*lR-3567 *IR-3569 1R-3572 *lR-3577 100 pom S*IR-3711 *lR-3725 *lR-3752 *lR-3757 30 1)[) *lR-3765 *lR-3776 *lR-3784 *IR-3787 IR-3809 10 i)i)m *lR-3833 *lR-3836 *IR-3837 *IR-3845 *IR-3853 Right Left Left Right Right Right Bilateral Bilateral Bilateral Bilateral Posterior subcapsular cataract Posterior subcapsular cataract Posterior subcapsular cataract Posterior subcapsular cataract Chronic uveitis-secondard to bleeding Diffused lens capacity (hypopyon);chronic uveitis with microphthalmia Posterior lens opacity Chronic superficialkeratitis Posterior subcapsular cataract Very pale choroidal circulation Left Right Left Right Diffuseg hyphemia AtrophyChronic superficialkeratitis Diffuse corneal opacity with microphthalmia Right Left Right Right Right Ocular opacitya Ocular opacity@ Phthisiibulbi (atrophy) AtrophyAtrophy involved with a massa- Right Bilateral Right Right Right a Ocular opacity Ocular opacitya a Ocular apacity AtrophyAtrophy@ NOTES: indicates blood sampling taken from eyes. indicates animal had possible SDA viral involvement. indicates clinical observationsign. Appendix Item H cc: M. T. Case r. 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/i. D. Johnson R. A. Prokop/V. Pothaprogada 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 FC-143 in a two year rat study. affects of FM-3924!@-and TEST ARTICLES: FM-3924!i and FC-143@@, 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, St. Paul, Minnesota. Riker Laboratories, Inc., DOSING INTERVAL: February - March 1981 through 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-299BCoC FM-3422 150 Appendix Item H (continued) RANDOMIZATION OF TEST SYSTEM: Animals will be assigned to the various groups by using a computer-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. changed on a weekly basis. Fresh treated and untreated diet will be 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@ 5CV, 50@ 50cr, 50@ 65,:@, 65* 50d, 50@ 5 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 (--16 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 1 and 2 year necropsies, tissue samples liver, blood, kidney, spleen, lung and bone marrow (femur) will he 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 (,-1-2- months) and during the final month of dosing. Eye abnormalities found on daily observations will be called to the attention of the staff veterinarian for further definition, as deemed necessary by the Study Director. 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 f. Alkaline g. CPK h. SGPT i. SGOT j. calcium Phosphatase 3. Urinalysis a. pH b. Specific Gravity c. Albumin d. Glucose 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.) 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 . testes*/--/-V.pdvm3.s 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 (vertebrae) 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 performed if indicated by experimental findings :it the high dose.level. 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 tumor bearing animals and tumor 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). ibinski, BA Advanced Toxicologist Study Director Date 14. T. Case, DVM, PhD Manager, Patholocly-Toxicology Safety Evaluation Laboratory Date J D. Henderson, Jr.,VDVM, M@nager, Laboratory Animal Medicine and Pathology Y/ 9& MS Date F. D. Gr@ttith, PhD manager, Toxicology Services Sponsor Representative Date Lk) t' W. C. McCormick, MS rYa- Toxicologist Alternate Sponsor Representative Appendix Item H (concluded) Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats Amendments to the Protocol AS of study day 183, body weights and food consumption will be recorded once every two weeks. Due to the unexpected leaving of Dr. J.D. Henderson, the staff veterinarian from Riker Laboratories, the final eye examination of the surviving controls and high dose FM-3924 and FC-143 rats will be performed by Dr. Steven Bistner, 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. APPENDIX ITEM I STATEMENT OF QUALITY ASSURANCE FOR EXPERIMENT 0281CROO12 "Two Year Oral (Diet)Toxicity/CarcinogenicityStudy of Fluorochemical FM-3924 in Rats" Audits and inspections were performed by the Riker Compliance Audit unit for the above titled study, and reported to the study director and to managment as follows: Date Performed Date Reported 5/13/1981 5/18/1981 6/23/1981 11/05/1981 11/11/1981 6/02/1981 5/20/1981 6/26/1981 11/13/1981 11/13/1981 11/20/1981 2/08/1982 2/09/1982 2/12/1982 3/10/1982 12/01/1981 2/16/1982 2/12/1982 3/02/1982 3/31/1982 3/31/1982 4/15/1982 5/10/1982 5/18/1982 8/18/1982 4/02/1982 5/03/1982 5/20/1982 5/20/1982 8/26/1982 11/09/1982 11/22/1982 1/25/1983 2/22/1983 4/12/1983 11/22/1982 12/01/1982 2/04/1983 3/15/1983 5/17/1983 4/15/1983 4/18/1983 4/26/1983 8/04/1983 9/24/1984 5/05/1983 4/21/1983 6/03/1983 8/05/1983 9/27/1984 12/19/1986 3/31/1988 4/06/1988 3/10/1987 4/06/1988 4/06/1988 'iD.ukf- Compliance Audit 3M Riker APPENDIX ITEM J CHEMICAL ANALYSES OF FM-3924 AND STABILITY ANALYSIS OF FM-3924 IN DIET 15 Q1--I)",@ InterrCioarlresponrience cc: M.T. Case - 21@-2 E.G. Lamprecht - 212-3 W.C. McCormick - 220-2E-02 W.H. Pearlson - 22"-@-6SE-04 R.A. Prokop - 236-23 L.&,! Sibinski - 213-3-3- To: D. R. RICKER - 53-4N Appendix Item J COMMERCIAL CHEMICALS ANALYTICAL REPORT #318 Frcm L. D. WINTER - 236-2B subiect: FM-3924, Lot 547, PRE AND POST -STUDY ANALYSIS Date: MARCH 23, 1982 Reference: Commercial Chemicals Analytical Request #16474. Riker Study 0281 CR 0012, Compound #T-2999 CoC and others. A light, straw colored waxy solid labeled FM-3924, lot 547, was received on 12/3/80 for characterization and analysis. This material was analyzed and used in several studies. The material has been analyzed by GLC and I.R. several times since and will be checked several more times till the completion of the two year study. The sample has @een analyzed as follows: Gas Chromatography of sample as received. QC (14310) All in Area Initial 3/31/,ql 3/5/P,2 Amide C3 c 4 all LB c5 C6 c 8 +C 7 +Isomers H.B. 0.5 10.6 88.9 Nil n4 0.6 1.2 1.8 1.5 4.8 88.9 0.6 U./ 0.6 1.3 1.7 1.6 4.3 88.9 0.8 0.4 0.6 1.2 1.8 1.5 4.8 88.9 0.6 All values are within experimental and integration parameters. meet QC specifications. Values Appendix Item J CCD Analytical R-aport 4318 -2- L. D. Winter Elemental Analysis: Based on C8 % Thero: '0 Found. c H N s F 0 by diff. 25 .2 1.75 2.45 5.6 56.66 8.4 24.6 1.5 2.6 5.3 57.0 9.0 MW = 571 Melting Point: Initial Recheck 38-480C 38-480C Spectroscopic: Infrared spectra 16474-2, -3, -4 are identical to each other and match reference spectra. 16474-2 was obtained Nov. 14, 1980 16474-3 Mar. 31, 1981 16474-4 Mar. 5, 1982 NMR spectra H8385, H8387, F8390, F8'j9lwere obtained on December I and 2, 1980. These were to confirm structure and not repeated. Structure was confiniied. The isoiiiedristribution wis found to be 69.6@'straight chain, 10..9% (CF3)2CF branched, and 19.5% backbone branching. CONCLUSIONS: FM-3924, lot 547 has an analysis within specifications, representative of commercial material. is stable and is LDW:df 1 5q InternaClorrespondence Appendix Item J To. From: Subjeci@ ()ate: COMMERCIAL CHEMICALS ANALYTICAL REPORT #347 L. J. SIBINSKI - 218-3-3 R. M. PAYFER - 236-2B MID STUDY PURITY JUNE 22, 1982 CHECK OF FM-3924 FEEDING STUDY (T-2999CoC) FOR RIKER NO. 0281CROO12 Reference: Commercial CheinicalsAnalytical Request No. 18318, Analytical Report #318 A light, straw-colored waxy solid labeled FM-3924, Lot 547 was received on 5/17/82 for a mid-study purity check. The sample was analyzed by GLC, IR, and elemental analysis to coinpare it to earlier data. The results are as follows: GLC Data (Area %) Inerts Amide C3 C4 C5 C6 C7 and C8 and High Boilers isomers 0.7 0.2 1.3 2.2 1.9 4.9 88.9 0.2 Elemental Analysis: % Theor. % Found c H N s F 0 by difference 25.2 1.75 2.45 5.6 56.66 8.4 25.0 1.8 2.7 6.1 55.3 9.1 f@ppendix Item J -2 Melting Point: 38-48'C Infrared spectra obtained (18318-1)was identicalto earlier spectra. Conclusions: All results are within experiinentalerror of previous results, so there has Aeen no chan detected in FM-3924, Lot 547. RMP hc dc: M. T. Case - 218-2 E . G. Lainprecht- 218-3 J. D. LaZerte - 236-1 W. C. McCormick - 220-2E-02. V. Pothapragada - 236-GB L. D. Winter - 236-2B ll5q 7 InternaClorrespondence Appendix Item J ro F,Orn, Sublc-cl f)ale COMMERCIAL CHEMICALS ANALYTICAL REPORT #412 L. J. S[ii[NSKI- 218-3-3 R. M. PAYFER - 236-2B r3 STUDY PURITY c@,4 JUNE 15, 1983 CHECK OF FM-3924 (T-2999CoC) FOR FEEDING STUDY NO. 0281CROO12 RIKER Reference: CoininercialCheinicals Analytical Request #18318, 19330 Analytical Report 1318, 347 A light, straw-colored waxy solid labeled FM-3924, Lot 547 was received on 4/18/83 for an end of study purity check. The sample @qasanalyzed by GLC, IR, and elemental analysis to compare it to earlier data. The results are as follows: FLC Data (Area '4) Inerts Amide C3 C4 C5 C6 C7 & C8 and g.,l@,G isoiners 3.71 0.36 1.24 2.00 1.62 4.59 85.75 0.76 Elemental Analysis: % Theor. % Found c H N s F 0 by difference 25.2 1.75 2.45 5.6 56.66 8.4 25.3 1.8 2.7 5.3 55.2 9.7 15 Appendix Item J 2 Me] tiny Point. 40-460C Infrared spectra obtained (19330-1)was identical to earlier specta. Conclusions: All results are within experiiiientaelrror of previous results, so there has been no chang det cted in FM-3924, Lot 547. R,'IP/hc dc: M. T. Case 213-2 E. G. Lainprecht- 218-3 J. D. LaZerte - 236-1 W. C. McCorinick - 220-2E-02 V. Pothapragada - 236-GB L. D. Winter - 236-28 50/ Appendix Item J InternaClorrespondence 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 - 236-2B - 236-3A - 236-2B To: L. J. Sibinski - 218-3-3 From: P. J. Colbert - 236-2B S,bjecl: GLC Analysis of FM-3924 (T-2999CoC) Blended into Ground Lab Chow. D,,e@ April 9, 1981 CCO Analytical Report #202 Reference: Request Method Commercial Chemicals Analytical Laboratory #16999 Commercial Chemicals Analytical Laboratory #G30-0481 Four samples of FM-3924 (W.R. ETFOSE) blended into Ground Lab Chow, along with two blank Ground Lab Chow samples, were received from L. J. Sibinski on 3-23-81 for analysis. The samples were labeled as follows: Compound FM-3924 Theoretical pM FM-3924 Concentrate (blended 3-20-81) 200 ppm Blank Ground Lab Chow for concentrate 0 ppm FM-3924 Top Sample (blended 3-23-81 FM-3924 Mid Sample (blended3-23-81) 100 ppm 100 ppm FM-3924 Bottom Sample (blended 3-23-81) 100 ppm Blank Ground Lab Chow for Top, Mid, Bottom samples 0 ppm The FM-3924 Concentrate and blank were analyzed for content on 3-23-81. The Top, Mid, Bottom and Blank samples were analyzed for content and stability on the initial blending day (3-23-81) and on week 1 and 2 post blend. The samples for post blend were prepared by placing the Ground Lab Chow in 4 oz. jars on 3-23-81 and placing them in a metal cabinet L) Appendix Item J L. J. Sibinski April 9, 1981 Page 2 without the covers on the jars, leaving the samples open to air. The 1 and 2 week post blend samples were taken from the jars on 3-30-81 and 4-6-81. The results are as follows: ppm (ug/g) FM-3924 on Compound 3-23-81 3-30-81 4-6-81 FM-3924 Concentrate 196 - - FM-3924 Concentrate 0 - - Blank FM-3924 Top Sample 100 99 91 FM-3924 Mid Sample 98 99 84 FM-3924 Bottom Sample 99 96 85 FM-3924 Top, Mid, Bottom. 0 0 0 Sample Blank PJ.F/r.iao 7r,-