Document em8YYDkbanqOe9vm5a5aexyDg

HAZLETON WISCONSIN O s T O F F I C E BOX 754$ ADlSON. WISCONSIN 53707*7545 AR226-0w a C O R N IN G uooratorv Se*v<es C o rn u a Sponsor 3H St. Paul, Minnesota FINAL REPORT Study Title; 13-Week Dietary Toxicity Study with T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) in Male Rats Data Requirement: Guideline 82-1 ftuthflf: Matthew J. Palazzolo, PhD, DABT Oi.t: May 17, 1993 Performing Laboratory Hazleton Wisconsin, Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704 Laboratory Pro.iect Identification: HWI 6329-100 VOLUME I OF II Phone FOR E X P R E 5 S - M A U DELIVERY Page 1 of 657 C01766 HWI 6329-100 COMPLIANCE STATEMENT 13-Week Dietary Toxicity Study with T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) in Male Rats All aspects of this study that were carried out by Hazleton Wisconsin, Inc., and Hazleton Washington, Inc., were in accordance with the Environmental Protection Agency Good Laboratory Practice Standards, 40 CFR 160. Study Director Director Toxicology Hazleton Wisconsin, Inc. To the best of my knowledge, the above statement is complete and accurate. Sponsor's Representative 3M Date To the best of my knowledge, this report is complete and unaltered. Applicant 3M Date 2 C01767 This Page Intentionally Left Blank HWI 6329-100 3 C01768 HWI 6329-100 QUALITY ASSURANCE STATEMENT 13-Week Dietary Toxicity Study with T-5180, Ammon1U Periluorooctanoate (CAS No. 3825-26-1) 1n Male Rats The report for this study, with the exception of Appendix E, has been reviewed by the Quality Assurance Unit of Hazleton Wisconsin, Inc., in accordance with the Good Laboratory Practice Standards as set forth 1n 40 CFR 160.35 (b) (6) (7). The report Identifies and/or describes the authorized methods and Standard Operating Procedures followed 1n the conduct of the study. The Quality Assurance Unit has also conducted the following Inspections of the testing facilities used 1n the conduct of this study and has submitted written reports of these Inspections to the Study Director. Written status reports of Inspections and findings are submitted to Management according to Hazleton Wisconsin, Inc., Standard Operating Procedures. Date of Inspection Type of Inspection Date Issued to Studv Director 02/20/90 Protocol Review 02/20/90 03/02/90 Protocol Amendment Review 03/07/90 12/27/90 Body Weight Measurement 12/27/90 12/27/90 Food Consumption Measurement 12/27/90 12/27/90 Animal Observation 12/27/90 01/02/91 Test Material Preparation 01/02/91 01/02/91 Sample Analysis 01/02/91 01/02/91 Test Material Administration 01/02/91 01/02/91 Prepared Test Material Dispensation 01/02/91 01/14/91 01/21/91 01/24/91 02/12/91 Protocol Amendment Review Protocol Amendment Review C11nical/Pharmacok1net1c Sampling Necropsy 01/14/91 01/21/91 01/24/91 02/12/91 03/25/91 04/29/91 04/30/91 CUnical/Pharmacokinetic Sampling Oata Review Data Review 03/25/91 04/30/91 04/30/91 05/16/91 Necropsy 05/16/91 4 C01769 Dito of Inspection 05/23/91 07/22-26,29-31, 08/01,02,05-07/91 09/13/91 11/18-12/04/91 11/20-12/04/91 09/28/92 02/19-24/93 03/23/93 04/08/93 QUALITY ASSURANCE STATEMENT Type of Inspection Histology Operation Data Review Special Analysis Data Review Report Review Protocol Amendment Review Report Review Protocol Amendment Review Report Review HWI 6329-100 Date Issued to Study Director 05/23/91 08/07/91 09/18/91 12/05/91 12/04/91 09/28/92 02/24/93 03/23/93 04/08/93 - y ; JohirD. Bolling (/ Representative, Quality Assurraaince Unit Date 3 5 001770 HWI 6329-100 STUDY IDENTIFICATION 13-Week Dietary Toxicity Study with T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) in Male Rats Test Material Sponsor Study Monitor Study Director Study Location Study Timetable In-Life (Experimental) Start Date In-L1fe Termination Date Experimental Termination Date T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Roger G. Perkins, PhD, DABT 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Matthew J. Palazzolo, PhD, DABT Hazleton Wisconsin, Inc. P.0. Box 7545 Madison, Wisconsin 53707 (608) 242-2622 Hazleton Wisconsin, Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704 December 20, 1990 May 17, 1991 May 17, 1993 6 001771 HWI 6329-100 Toxicology Matthew J. Palazzolo, PhD Dipl ornate, ABT Study Director Director Janice D. Maneke Study Coordinator Toxicology Operations Larry Giltner Group Leader Sample Collection Robert K. Young Group Leader Rodent Toxicology Shane Eith Group Leader Support Services Compound Preparation Dixie Bushee Group Leader Laboratory Animal Veterinarian Cindy 0. Cary, DVM Diplomate, ACLAM C l i n ^ l fjthQlpgy Robert L. Hall, DVM, PhD Dipl ornate, ACVP Clinical Pathologist KEY PERSONNEL Clinical Pathology (Continued! Ronald Markevitch Supervisor Anatomical Pathology Thomas E. Palmer, PhD Anatomical Pathologist Dennis Hoffman Group Leader Necropsy Richard Becker Group leader Histology Anne Mosher Group Leader Pathology Data Agricultural Chemistry Mandla A. Tshabalala, PhD Manager Methods Development Immunochemistrv Joanne Satyanarayan Supervisor Quality Assurance Sherry R. W. Petsel Manager 7 001772 CONTENTS VOLUME 1 OF II COMPLIANCE STATEMENT QUALITY ASSURANCE STATEMENT STUDY IDENTIFICATION KEY PERSONNEL ABSTRACT OBJECTIVE REGULATORY COMPLIANCE MAINTENANCE OF RAW DATA, RECORDS, AND-SPECIMENS TEST MATERIAL Identification and Characterization Storage Conditions Reserve Samples Safety Precautions TEST SYSTEM Test Animal Identification STUDY DESIGN PROCEDURES Dose Preparation Retention Samples Dose Analyses Dose Administration Acclimation Housing and Maintenance Antemortem Observations Body Weights Food Consumption Hormone Analysis Test Material Residue Analysis Clinical Pathology Anatomical Pathology Statistical Analyses HWI 6329-100 Eiss 2 4 6 7 12 14 14 14 14 14 14 14 14 15 15 15 15 16 16 16 17 17 17 18 18 18 18 19 19 19 19 20 001773 HWI 6329-100 CONTENTS (Continued) VOLUME I OF II (Contin_uedl RESULTS Dose Analyses Acclimation Survival Antemortem Observations Body Weights Mean Body Weight Gains Food Consumption Compound Consumption Hormone Analysis Test Material Residue Analysis Clinical Pathology Anatomical Pathology CONCLUSIONS SIGNATURES REFERENCES PATHOLOGY REPORT COMMENTS ON THE DATA CODES, ABBREVIATIONS, AND UNITS General Codes and Abbreviations Abbreviations and Units for Clinical Chemistry Codes for Anatomical Pathology TABLE 1 Summary of Antemortem Observations 2 Mean Body Weights and Standard Deviations (g) 3 Mean Body Weight Gain (g) 4 Mean Food Consumption and Standard Deviations (g/wk) 5 Mean Compound Consumption (mg/kg/day) 6 Summary of Clinical Chemistry Data - Week 5 7 Summary of Clinical Chemistry Data - Week 8 8 Summary of Clinical Chemistry Data Week 14 9 Summary of Clinical Chemistry Data - Week 22 10 Summary of Absolute Organ Weight Oata (g) - 5 Week Sacrifice 11 Summary of Absolute Organ Weight Data (g) - 8 Week Sacrifice 12 Summary of Absolute Organ Weight Oata (g) - 14 Week Sacrifice 13 Summary of Absolute Organ Weight Data (g) - 22 Week Sacrifice Page 20 21 21 21 21 22 22 22 22 23 23 23 23 24 25 26 27 31 32 33 34 36 38 41 45 49 53 56 57 58 59 60 62 64 66 9 001774 HWI 6329-100 CONTENTS (Continued) VOLUME I OF II (Continued) Pag? TABLE (Continued) 14 Summary of Organ-to-Body Weight Percentages - 5 Week Sacrifice 15 Summary of Organ-to-Body Weight Percentages - 8 Week Sacrifice 16 Summary of Organ-to-Body Weight Percentages - 14 Week Sacrifice 17 Summary of organ-to-Body Weight Percentages - 22 Week Sacrifice 18 Summary of Organ-to-Brain Weight Ratios - 5 Week Sacrifice 19 Summary of Organ-to-Brain Weight Ratios - 8 Week Sacrifice 20 Summary of Organ-to-Brain Weight Ratios - 14 Week Sacrifice 21 Summary of Organ-to-Brain Weight Ratios - 22 Week Sacrifice 22 Incidence of Macroscopic Observations - 5 Week Sacrifice 23 Incidence of Macroscopic Observations - 8 Week Sacrifice 24 Incidence of Macroscopic Observations - 14 Week Sacrifice 25 Incidence of Macroscopic Observations - 22 Week Sacrifice 26 Incidence of Microscopic Observations - 5 Week Sacrifice 27 Incidence of Microscopic Observations - 8 Week Sacrifice 28 Incidence of Microscopic Observations - 14 Week Sacrifice 29 Incidence of Microscopic Observations - 22 Week Sacrifice 30 Incidence of Severity of Microscopic Observations - 5 Week Sacrifice 31 Incidence of Severity of Microscopic Observations - 8 Week Sacrifice 32 Incidence of Severity of Microscopic Observations - 14 Week Sacrifice 33 Incidence of Severity of Microscopic Observations - 22 Week Sacrifice 34 Summary of Hormone Data 35 Summary of Test Material Residue Analysis 36 Results of Method Validation for Determination of T-5180 in Rodent Food Expressed as the Percent of Recovery 37 Results of Stability Analysis 38 Results of Homogeneity Analysis 39 Results of Dose Preparation Analysis 68 70 72 74 76 78 80 82 84 87 90 93 96 99 102 105 108 111 114 117 120 122 123 126 128 130 APPENDIX A Protocol Protocol Protocol Protocol Protocol Material Deviations TP9321 Amendment No. 1 Amendment No. 2 Amendment No. 3 Safety Data Sheet 132 133 134 147 150 152 154 APPENDIX B Individual Antemortem Observations Individual Body Weights (g) Individual Food Consumption (g/wk) 158 159 177 lgg APPENDIX C Individual Clinical Chemistry Values 221 222 10 C01775 CONTENTS (Continued) VOLUME II OF II APPENDIX D Individual Individual Individual Individual Absolute Organ WeightData (g) Organ-to-Body Weight Percentages 0rgan-to-Bra1n WeightRatios Animal Pathology Data APPENDIX E Quality Assurance Statement Individual Hormone Analysis Data APPENDIX F Results of Individual Test Material Residue Analyses APPENDIX G Method Validation for FC-143 1n Feed Method Validation for T-5180 1n Rat Serum HWI 6329-100 Ms 232 233 254 275 295 620 621 622 629 630 644 645 651 11 C01776 HWI 6329-100 ABSTRACT The purposes of this study was to assess the subchronic toxicity of T-5180, Ammonium Perfluorooctanoate, when fed to rats for at least 13 weeks and to evaluate reversibility of any toxic effects after approximately 8 weeks without treatment. There were 320 male Crl:CD*BR rats assigned at random to six groups (55/group in Groups 1 through 5, 45/group in Group 6) and fed diets containing 0 (nonpair-fed control), 1, 10, 30, 100, or 0 ppm (control group pair-fed to the group fed 100 ppm) for up to 13 weeks. In addition, 10 animals/sex/group in Groups 1 through 5 (designated as recovery animals) were fed basal diet for 8 weeks posttreatment. The animals were observed at least twice daily. Body weights were recorded once before initiation of treatment, weekly thereafter, and on the day of necropsy. Food consumption was recorded weekly for animals given 1, 10, or 30 ppm and for the nonpair-fed control group. Food consumption was recorded daily for the pair-fed groups (animals given 0 or 100 ppm). Food consumption was recorded weekly for all groups during recovery. There were 15 animals/group sacrificed after 4, 7, or 13 weeks of treatment; 10 animals/group in Groups 1 through 5 were sacrificed after 13 weeks of treatment and 8 weeks without treatment. Hepatic CoA Oxidase activity was determined for five animals/group at each scheduled sacrifice. Serum samples from 10 animals/group were collected at each scheduled sacrifice during treatment and from 5 animals/group during recovery for hormone analysis. Nonfasted rats were anesthetized with methoxyf1urane and blood was collected from the descending vena cava. These samples were analyzed for estradiol, testosterone (total) and luteinizing hormones, and for test material content. One animal given 100 ppm was sacrificed during Week 4 due to severe neck sores; all other animals survived to scheduled sacrifice. There were no test materialrelated effects on antemortem observations. Body weight and cumulative body weight gain for the 100-ppm animals were consistently significantly lower than those of the nonpair-fed control group throughout treatment. Animals fed 100 ppm consumed significantly less food than the nonpair-fed control group at Weeks 1 and 2. Overall, there was no significant difference in mean food consumption between the pair-fed and nonpair-fed groups. Dietary administration of the test material resulted in higher hepatic palmitoyl CoA oxidase activity that was statistically significant at dose levels of 30, and 100 ppm at Weeks 5, 8, and 14. Animals given 10 ppm had transiently higher hepatic palmitoyl CoA oxidase activity that was statistically significant at Week 5. The mean enzyme activities for animals given 10, 30, or 100 ppm were highest at Week 8 . No difference in hepatic palmitoyl CoA oxidase activity was seen at Week 22; that is after 8 weeks recovery following the 13 weeks of dietary administration of the test material. The effect was dose-dependent and reversible. 12 001777 HWI 6329-100 Administration of the test material caused increased absolute and relative liver weights and hepatocellular hypertrophy 1n the livers of animals given 10, 30, or 100 ppm after at least 4, 7, and 13 weeks of treatment. The progression of hepatocellular hypertrophy did not appear to be affected by the length of treatment. The changes observed are suggestive of a test material effect on intracellular metabolism and may be associated with peroxisome proliferation. At the end of recovery, these changes were not observed in animals, indicating that the test material-related increases in absolute and relative liver weights were reversible. There was no consistent pattern for the hormone determinations which could be attributed to the test material over the entire course of the study. None of the hormone levels were significantly different between groups although there appeared to be some indication of elevated estradiol for the 100 ppm group at the Week 5 determination. Based on the results of this study, the no-observable-adverse-effect level for T-5180 when fed ad libitum to rats for at least 13 weeks is 100 ppm; the no-effect level is 1.0 ppm. 13 001778 HUI 6329-100 OBJECTIVE The purposes of this study was to assess th subchronic toxicity of T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) when fed to rats for at least 13 weeks and to evaluate reversibility of any toxic effects after approximately 8 weeks. REGULATORY COMPLIANCE All aspects of this study that were carried out by Hazleton Wisconsin (HWI) and Hazleton Washington (HWA) were in accordance with the Environmental Protection Agency Good Laboratory Practice Standards, 40 CFR 160. MAINTENANCE OF RAW DATA, RECORDS, AND SPECIMENS Original paper data, magnetically encoded records, and a copy of the final report will be retained 1n the archives of HWI. Specimens will be transferred to the Sponsor and are to be retained in accordance with 40 CFR 160.195. TEST MATERIAL Identification and Characterization The test material, T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1), Lot No. 115, is a light colored powder. It was received at HWI on November 7, 1990, and was assigned HWI Sample No. 0058A1. Information on synthesis methods, composition, or other characteristics that define the test material is on file with the Sponsor. Storage Conditions The test material was stored at room temperature. Reserve Samples Reserve samples of the test material were taken and stored 1n a freezer. These samples were returned to the Sponsor on December 18, 1991 to be retained 1n accordance with 40 CFR 160.195. Any remaining test material was returned to the Sponsor on December 18, 1991. Safety Precautions Personnel involved with the study wore the apparel required by the Material Safety Data Sheet (MSDS) provided by the Sponsor. HWI SOPs applied for any apparel not covered by the MSDS. ^ 001779 HWI 6329-100 TEST SYSTEM Test Animal Male Crl:CDBR rats were obtained from the Portage, Michigan, facility of Charles River Laboratories, Inc. (Wilmington, Massachusetts), on December 7, 1990. The animals were approximately 41 days old at initiation of treatment and weighed 180.7 to 229.1 g. The rat is frequently used in safety evaluation studies as a representative of a rodent species. Male rats were used to characterize the effects of the test material on testicular physiology. Identification Each animal was assigned a temporary number upon arrival. Before initiation of treatment, each animal was assigned a permanent number and identified with an ear tag. All data for an animal are recorded under one of these numbers. STUDY OESIGN Animals were assigned to the study using a computer-generated randomization according to the following design: Group Dose Level (pom) Number of Males* 10 21 3 10 4 30 5 100 6 0b 55 55 55 55 55 45 a 10 animals for Groups 1 through 5 (designated as recovery animals) were treated for at least 13 weeks, then treatment was discontinued (animals were fed the basal diet) and they were observed for reversibility, persistence, or delayed occurrence of toxic effects for at least 8 weeks posttreatment. b Animals in Group 6 were pair-fed with the high-dose animals (Group 5) throughout treatment. Due to the pair feeding requirements, the pair-fed control animals (Group 6) were initiated on test one day after all other groups. 15 GQ17S0 HWI 6329-100 Individual body weights at the time of randomization were within 2 standard deviations of the mean body weight and group-mean body weights were not statistically different at the 5.0% probability level (Winer, 1971). PROCEDURES This study was conducted in accordance with HWI Protocol TP9321 dated November 30, 1990, and Amendment Nos. 1 through 3. The protocol, protocol amendments, protocol deviations, and MSDS are in Appendix A. Unless otherwise indicated, all procedures were done in accordance with the above-referenced documents, HWI SOPs, or both. Dose Preparation Carrier. Certified Rodent Chow* #5002 was used as supplied. Test Material. Dietary concentrations were based on the test material as supplied. Diets were prepared weekly. A specified amount of carrier (basal diet) was weighed into a labeled Hobart mixing bowl from which approximately 200 g were removed and placed in a Waring blender; the required amount of test material was then weighed and added to the Waring blender and overlaid with approximately 50 g of carrier, then thoroughly blended; this premix was transferred to the mixing bowl. The contents of the mixing bowl were mixed for approximately 15 minutes to prepare the base diet. Diets were made for Groups 2, 3, 4, and 5 by placing a specified amount of basal diet into a labeled Hobart mixing bowl. A specified amount of base diet was added to the mixing bowl. The contents of the mixing bowl were mixed for approximately 15 minutes. Beginning at Week 3, the mixing procedure for Group 2 was modified. A specified amount of basal diet was placed into a labeled Hobart mixing bowl and a specified amount of the Group 3 diet was added to the mixing bowl. The contents of the mixing bowl were mixed for approximately 30 minutes. The diets were stored at room temperature (Weeks 1 through 8) or in a refrigerator (Weeks 9 through 14) in containers until diet administration. Retention Samples Samples of each mixed batch were stored in a freezer for at least 6 months for possible future analysis. 16 0017S1 HWI 6329-100 Dose Analyse! Assays for the test material in the basal diet were done by HWI using an analytical method developed and validated by HWI (Appendix G). Homogeneity was determined for all concentrations at Week 1. Homogeneity was also determined for the low-dose (1 ppm) concentration at Week 2. Samples taken from the top, bottom, and two opposing sides of the mix were assayed in duplicate for test material content. To evaluate the stability of the test material in the basal diet, four sets of samples were taken from each dose preparation mixed for Week 1. One set was analyzed on the day of mixing, one set was analyzed after storage for 1 day in a refrigerator and 7 days at room temperature; and the remaining sets were analyzed after being stored in a freezer for 2 or 7 weeks. A second stability was done at Week 12 to evaluate the actual storage conditions during the first eight weeks of the study. Two sets of samples were taken from each dose preparation; one set was analyzed on the day of mixing and the second set was analyzed after storage at room temperature for 8 days. All diets were assayed each week for the first 4 weeks. Each week thereafter, a sample of the control diet and one test material dietary concentration was selected sequentially for analysis. These samples were analyzed as a group approximately every 4 weeks. All samples were stored in a freezer until analyzed. Dose Administration Dietary admixture was used to compare data with other studies dosed in a similar fashion. The test material was administered ad libitum for at least 13 weeks. After 13 weeks of treatment, 10 males (designated as recovery animals) from all groups, except the pair-fed control group (Group 6), were fed basal diet for at least 8 weeks posttreatment. Acclimation The animals were received on December 7, 1990, and were acclimated in Animal Room 315 for 13 days before initiation of treatment. During acclimation, the animals were observed daily for abnormalities indicative of health problems. 17 0017S2 HWI 6329-100 Housing and Maintenance Animal Room 315 was used for this study. Environmental controls for the animal room were set to maintain a temperature of 72*F 6*, a relative humidity of 50% 20%, and a 12-hour 1ight/12-hour dark cycle. Variations from these conditions were documented and were considered to have had no effect on the outcome of the study. The animals were housed individually (except for the first week of acclimation) in stainless steel, screen-bottom cages. When animal health status warranted, selected animals were individually housed in polycarbonate cages with hardwood chip bedding. Animal husbandry and housing at HWI comply with standards outlined in the Guide for the Care and Use of Laboratory Animals (NIH Publ. No. 86-23, 1985). Certified Rodent Chow #5002 (Purina Mills, Inc.) was provided ad libitum. The lot numbers are recorded. The diet is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Water was provided ad libitum. Samples of the water are analyzed by HWI for total dissolved solids, hardness, and specified microbiological content and for selected elements, heavy metals, organophosphates, and chlorinated hydrocarbons. The results are on file with HWI. There were no known contaminants in the food or water that would have interfered with this study. Antemortem Observations The animals were observed twice daily (a.m. and p.m.) for mortality, moribundity, and signs of toxicity. At least once weekly, each animal was removed from its cage and a detailed examination was done. Body Weights Individual body weight data were recorded for randomization, on the first day of treatment, weekly thereafter, and on the day of necropsy (except for two animals that were not weighed before exsanguination). Food Consumption Individual food consumption data were recorded daily for animals that were pairfed (Groups 5 and 6) and weekly for all other animals during treatment. During recovery, food consumption was recorded weekly for all animals. 18 C017S3 HWI 6329-100 Hormone Analysis Serum samples were collected from 10 anlmals/group at each scheduled sacrifice during treatment and from 5 animals/group during recovery. Nonfasted rats were anesthetized with methoxyflurane, and blood was collected from the descending vena cava and stored on ice until centrifugation. Serum samples were stored at approximately -70*C (except storage location for 3 collection dates cannot be verified), then packed on dry ice, and shipped to Hazleton Washington for analysis. Serum samples were analyzed for estradiol and testosterone (total) and luteinizing hormones. Test Material Residue Analysis Samples of liver, testes, lungs, and subcutaneous adipose tissue were collected from all animals at necropsy and stored frozen for possible analysis. Serum samples collected from up to 10 animals/group at each scheduled sacrifice during treatment and from 5 animals/group during recovery were analyzed for test material residue. Clinical Pathology A section of liver was obtained from all animals at each scheduled sacrifice and flash frozen in liquid nitrogen. A section of liver from 5 animals/group at each scheduled sacrifice was assayed for the level of palmitoyl CoA oxidase as an indicator of peroxisome proliferation. Anatomical Pathology A necropsy was done on the animal that was sacrificed in a moribund condition. After 4, 7, or 13 weeks of treatment, nonfasted animals were anesthetized with methoxyflurane, weighed, exsanguinated, and necropsied between 7:00 a.m. and 10:00 a.m. (except for three animals that were necropsied after 10:00). Recovery animals were sacrificed after 8 weeks without treatment. The necropsy included a macroscopic examination of the external surface of the body; all orifices; the cranial cavity; the external surfaces of the brain and spinal cord; the nasal cavity and paranasal sinuses; and the thoracic, abdominal, and pelvic cavities and viscera. At the scheduled necropsy, the following organs (when present) were weighed; paired organs were weighed separately: Brain Liver Lungs Testes (one testis) Accessory sex organs (seminal vesicle, prostate, coagulating gland, urethra) 19 001754 HWI 6329-100 Organ-to-body weight percentages and organ-to-brain weight ratios were calculated. The following (when present) or representative samples were collected from scheduled sacrifice animals and preserved in 10% phosphate-buffered formalin, unless otherwise specified: Lesions Brain Liver Lungs Testes (one testis) Accessory sex organs (seminal vesicle, prostate, coagulating gland, urethra) The above (as appropriate) were embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically from all animals from which they were collected. At the scheduled necropsy samples of the following tissues were preserved in glutaraldehyde for possible electron microscopic evaluation: Brain Liver Lungs Testes (one testis) Accessory sex organs (seminal vesicle, prostate) Statistical Analyses The statistical methods used are described below. Levene's test (Levene, 1960) was done to test for variance homogeneity. In the case of heterogeneity of variance at p < 0.05, transformations were used to stabilize the variance. Analysis of variance [ANOVA (Winer, 1971)] was done on the homogeneous or transformed data. If the ANOVA was significant, Games and Howell Modified TukeyKramer test (Games and Howell, 1976) was used for pairwise comparisons between groups. One-way ANOVA was used to analyze body weights, cumulative body weight gains, food consumption, clinical chemistry, hormone values, organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios. Body weights, cumulative body weight gains, and food consumption values were analyzed for all groups (except Group 6) using the SAS program according to HWI methods. Group comparisons were evaluated at the 5.0% two-tailed probability level. RESULTS Groups 2, 3, 4, and 5 were compared with Group 1 ; Group 6 was compared with Group 5. 20 G017S5 HVfI 6329-100 Dose Analyses Results of test diet assays to confirm method validation, homogeneity, and stability and to verify dose levels for T-5180 are in Tables 36 through 39. Method validation results indicated that the method developed was suitable for the range of dietary concentration in the study. Mean homogeneity results for diets containing 30 ppm and 100 ppm were within 10% of the theoretical levels; these results Indicated that the mixing procedure produced a homogeneous distribution of T-5180 in the diet at these levels. Mean homogeneity results for diets containing 1 ppm and 10 ppm T-5180 were within 19% and 18% of the theoretical values, respectively. All test diets were considered stable under the storage conditions specified. The lower values of the theoretical (l.e., 78% for the sample stored refrigerated 1 day, than at room temperature 7 days, 75% for the sample stored at room temperature 8 days, and 77% for the sample stored frozen for 2 weeks before analysis) were consistent with the variability of the assay at the 1 ppm level. Dose preparation analysis results indicated that the appropriate dietary concentrations were achieved during the study. The assay results ranged from 70.0%-119%, 90- IS-116%, 87.0%-116% and 90.1%-111% of the theoretical dose levels of 1, 10, 30, and 100 ppm. Acclimation For this study, 370 males were received and acclimated. In general, animals in this shipment appeared healthy. The animals were released from acclimation by the laboratory animal veterinarian on December 17, 1990. One animal was excluded from study consideration due to small testes. There were 369 males in the randomization for assignment to groups (55/group for Groups 1, 2, 3, 4, and 5; 45/group for Group 6). Animals not selected for the study were sacrificed and discarded on December 21, 1990. Survival One animal given 100 ppm was sacrificed during Week 4 due to severe neck sores. All other animals survived until scheduled sacrifice. Antemortem Observations Antemortem observations are summarized in Table 1 ; individual data are in Appendix B. There were no test material-related antemortem observations. 21 001786 HWI 6329-100 Body Weights Body weight data are summarized in Table 2; individual data are in Appendix B. Body weights for the 100-ppm animals were significantly lower than the pair-fed control group (Group 6) at study initiation and were consistently significantly lower than the nonpair-fed control group (Group 1) throughout treatment (Weeks 1 through 13). During recovery, there were no statistical differences in body weights noted. There were no significant body weight changes for animals at 1, 10, or 30 ppm levels. Mean Body Weight Gains Mean body weight gain data are summarized in Table 3. Mean body weight gains for the 100-ppm animals were significantly higher than the pair-fed control group (Group 6) at Week 1 and were consistently significantly lower than the nonpair-fed control group (Group 1) throughout treatment (Weeks 1 through 13). Mean body weight gains were significantly lower than the nonpair-fed control group (Group 1) for animals given 10 or 30 ppm at Week 2. During recovery, there were no statistical differences in mean body weight gains noted. Food Consumption Food consumption data are summarized in Table 4 ; individual data are in Appendix B. Animals fed 100 ppm (Group 5) consumed significantly less food than the nonpairfed control group (Group 1) at Weeks 1 and 2. Overall, there was no significant difference in mean food consumption between the pair-fed and nonpair-fed groups. Compound Consumption Compound consumption data are summarized in Table 5. Animals were fed diets containing 1 , 10, 30, or 100 ppm of the test material. The amount of T-5180 consumed by the animals on a mg/kg of body weight/day basis was proportional to the dose as follows: Overall Mean SO JL 0.06 0.013 T-5180 fmq/kq/davl fliet Concentration (ppm) _UL _ 20_ 0.64 0.138 1.94 0.408 100 6.50 1.214 C01VS7 HWI 6329-100 Hormone Analysis Hormone analysis data are summarized in Table 34; individual data are in Appendix E. There were no statistically significant differences between groups. There was no consistent pattern for the hormone determinations which could be attributed to the test material over the entire course of the study. None of the hormone levels were significantly different between groups although there appeared to be some indication of elevated estradiol for the 100 ppm group at the Week 5 determination. Test Material Residue Analysis Results of test material serum analysis are summarized in Table 35; individual data are in Appendix F. Serum levels of T-5180 increased proportionally with dietary exposure concentration but there was no increase in serum T-5180 over the course of exposure. Clinical Pathology Hepatic Palmitoyl CoA Oxidase data are summarized in Tables 6 through 9; individual data are in Appendix C. The Pathology Report contains a complete discussion of the data. Dietary administration of the test material, T-5180, caused higher hepatic palmitoyl CoA oxidase activity at dose levels of 30 and 100 ppm that was statistically significant. The effect was dose-dependent and reversible. Animals given 10 ppm had transiently higher hepatic palmitoyl CoA oxidase activity that was statistically significant at Week 5 only. The mean enzyme activities for animals given 10, 30, or 100 ppm were highest at Week 8 . Anatomical Pathology Organ weights, organ-to-body weight percentages, and organ-to-brain weight ratios are summarized in Tables 10 through 21; macroscopic and microscopic findings are summarized in Tables 22 through 29; incidence of severity of microscopic observations are in Tables 30 through 33; all individual data are in Appendix 0. The Pathology Report contains a complete discussion of the data. Administration of the test material, T-5180, caused increased absolute and relative liver weights and hepatocellular hypertrophy in the livers of animals after at least 4, 7, and 13 weeks of treatment. Absolute liver weights and relative liver weights for animals fed 100 ppm were significantly higher than the pair-fed controls after 4, 7, and 13 weeks of treatment. The changes observed are suggestive of a test material effect on intracellular metabolism and may be 23 0017S3 HWI 6329-100 associated with peroxisome proliferation. During recovery, these changes were not observed in animals that were treated for at-least 13 weeks and untreated for at least 8 weeks, indicating that the test material-related changes were reversible. CONCLUSIONS Based on the results of this study, the no-observable-adverse effect level for T-5180 when fed ad libitum to rats for at least 13 weeks is 100 ppm; the no-effect level is 1.0 ppm. 24 SIGNATURES HWI 6329-100 JarfLCe 0. Maneke S t W y Coordinator Toxicology Matthew J. Pal . Dipl ornate, ABT Study Director Director Toxicology by and for Hazleton Wisconsin, Inc. ______ / n i ? Date 25 001790 HWI 6329-100 REFERENCES Games, P. A., and Howell, J. F., "Pairwise Multiple Comparison Procedures with Unequal N's and/or Variances: A Monte Carlo Study," Journal of Educational Statistics. 1(2):113-125 (1976). Institute of Laboratory Animal Resources Commission on Life Sciences, Guide for the Care and Use of Laboratory Animals. NIH Publication No. 86-23, U.S. Department of Health and Human Services, Public Health Service National Institutes of Health: Bethesda, Maryland (1985). Levene, H., "Robust Tests for Equality of Variances," Contributions to Probability and Statistics, (eds.) I. Olkin et al., Ch. 25, pp. 278-292, Stanford University Press: Stanford, California (1960). Winer, 8. J., "Design and Analysis of Single-Factor Experiments," Statistical Principles in Experimental Design. Second Ed., Ch. 3, pp. 149-260, McGraw-Hill: New York, New York (1971). 26 001794 HWI 6329-100 PATHOLOGY REPORT SUMMARY Dietary administration of T-5180 caused higher hepatic palmitoyl CoA oxidase activity at dose levels of 30 and 100 ppm that was statistically significant. The effect was dose-dependent and reversible. Animals given 10 ppm had transiently higher hepatic palmitoyl CoA oxidase activity that was statistically significant at Week 5. The mean enzyme activities for animals given 10, 30, or 100 ppm were highest at Week 8 . Administration of the test material, also caused increased absolute and relative liver weights and hepatocellular hypertrophy in the livers of animals after at least 4, 7, and 13 weeks of treatment. The changes observed are suggestive of a test material effect on intracellular metabolism and may be associated with peroxisome proliferation. In the recovery phase, these changes were not observed in animals that were treated for at least 13 weeks and untreated for at least 8 weeks, indicating that the test material-related changes were reversible. INTRODUCTION The purposes of this study were to assess the subchronic toxicity of the test material, T-5180 (Ammonium Perfluorooctanoate), when fed to rats for at least 13 weeks and to evaluate reversibility of any toxic effects. Four groups of male Crl:CD*BR rats (55/group) were fed diets containing the test material at levels of 1, 10, 30, or 100 ppm. Two control groups received no test material; one control group was pair-fed with the high-dose group throughout treatment. Ten animals were designated as recovery animals from each group except for the pair-fed controls. After at least 13 weeks of treatment, these animals were observed for reversibility, persistence, or delayed occurrence of toxic effects for at least 8 weeks posttreatment. During Weeks 5, 8, 14, and 22, animals were sacrificed and necropsied; macroscopic observations were recorded, organ weights were obtained, and tissues were preserved in fixatives as required by the protocol. One animal, sacrificed due to poor health during Week 4, was also necropsied. At the scheduled sacrifices, serum samples were collected for hormone analysis, tissue samples were collected and frozen for possible analysis for test material residue, and sections of liver were obtained for assaying hepatic palmitoyl CoA oxidase activity as an indicator of peroxisome proliferation. Microscopic examinations were performed on lesions, brain, liver, lungs, left testis, and accessory sex organs from all animals. Statistical comparisons were made between the treated groups and the nonpair-fed control group and between the high-dose group and the pair-fed control group. 27 00179a HWI 6329-100 RESULTS Clinical Pathology Individual values for hepatic palmitoyl CoA oxidase activity are in Appendix C. Mean values for each dose group and the results of statistical comparisons are in Tables 6 through 9. Week 5 . Animals given 10, 30, or 100 ppm had statistically significantly higher hepatic palmitoyl CoA oxidase activity than the nonpair-fed control animals. Animals given 100 ppm also had statistically significantly higher enzyme activi ty than the pair-fed control animals. Enzyme activity increased as dose levels increased. Week 8 . Animals given 30 or 100 ppm had statistically significantly higher hepatic palmitoyl CoA oxidase activity than the nonpair-fed control animals. Animals given 10 ppm had an apparently higher enzyme activity than the nonpair-fed control animals, but the difference was not statistically significant. Animals given 100 ppm also had statistically significantly higher enzyme activity than the pair-fed control animals. Enzyme activity increased as dose levels increased, and the activities for animals given 10, 30, or 100 ppm were higher at this interval than at Week 5. Week 14. Animals given 30 or 100 ppm had statistically significantly higher hepatic palmitoyl CoA oxidase activity than the nonpair-fed control animals. Animals given 100 ppm also had statistically significantly higher enzyme activity than the pair-fed control animals. Enzyme activity for animals given 30 or 100 ppm were lower at this interval than at Weeks 5 or 8 . Week 22. There were no differences for hepatic palmitoyl CoA oxidase activity between the nonpair-fed control and treated groups. Anatomical Pathology Individual anatomical pathology data are in Appendix 0. Individual terminal body weights, absolute organ weights, organ-to-body weight percentages, and organ-tobrain weight ratios are also in Appendix D. Mean weight values for each group are in Tables 10 through 21. Incidence summaries of the macroscopic and microscopic findings are in Tables 22 through 29. Scheduled Sacrifices. After 4 weeks of treatment, animals given 100 ppm had significantly lower terminal body weights when compared with nonpair-fed control animals. After 4, 7, or 13 weeks of treatment, absolute and relative liver weights were significantly higher for animals given 100 ppm when compared with those of either group of control animals. These liver weights were also significantly higher in animals given 30 ppm after 4 or 7 weeks of treatment. Liver-to-body weight percentages were significantly higher in the animals given 10 ppm after 4 weeks of treatment and in the animals given 30 ppm after 13 weeks of treatment. After 13 weeks of treatment, other significant organ weight changes included lower liver-to-body weight percentages in animals given 1 ppm and higher testes-to-body weight percentages (when compared with those of the nonpair-fed controls) in animals given 100 ppm. 28 C01793 HWI 6329-100 Macroscopically, there were few observations and no major differences in incidence between control and treated animals after 4, 7, or 13 weeks of treatment. Microscopically, minimal-to-slight hepatocellular hypertrophy was observed in the liver from animals given 10, 30, or 100 ppm after 4, 7, or 13 weeks of treatment. This change was characterized by an accentuated centrilobular pattern in which the hepatocytes appeared to have a more homogeneous cytoplasm, and the cell borders were rounded giving the cells a more plump appearance. Except for the enlarged appearance, the cells were otherwise unremarkable. The incidence and severity of this change increased with dose, but neither appeared to be affected by the length of treatment (Tables 30 through 33). All other observations were considered incidental findings. Recovery Sacrifice. Animals given 1 ppm had significantly higher absolute brain weights. There were no other significant changes in the remaining organ weight data. Macroscopically and microscopically, there were few observations and no major differences in incidence between control and treated animals after 13 weeks of treatment and after 8 weeks without treatment. DISCUSSION Dietary administration of the test material caused higher hepatic palmitoyl CoA oxidase activity at dose levels of 30 or 100 ppm that was statistically significant. The effect was dose-dependent and reversible. Animals given 10 ppm had transiently higher hepatic palmitoyl CoA oxidase activity that was statistically significant at Week 5. The mean enzyme activities for animals given 10, 30, or 100 ppm were highest at Week 8. Elevation of hepatic palmitoyl CoA oxidase activity indicates that the test material causes hepatocellular peroxisome proliferation. Dietary administration of the test material caused an increase in absolute and relative liver weights after at least 4, 7, or 13 weeks of treatment. Animals treated for at least 13 weeks and untreated for at least 8 weeks had no significant changes in liver weights. Microscopically, minimal-to-slight hepatocellular hypertrophy was observed in the livers from treated animals. These liver sections had an accentuated centrilobulated pattern in which the hepatocytes around the central vein appeared to be more plump and larger. In comparison with similar cells from the control animals, the cytoplasm of the affected cells appeared to be more homogeneous and lacking intracellular vacuoles. The cell borders were more distinct and the cells appeared to be more rounded. There was no evidence of any degenerative changes or abnormalities associated with the hypertrophy. The severity of the cellular enlargement did not appear to increase with length of treatment, and the absence of similar changes in the recovery animals 1s Indicative of reversibility. The changes observed in the liver are possibly from peroxisome proliferation or an increase in intracellular metabolism, increased storage of metabolic products, or both. All other organ weight changes and all macroscopic and microscopic observations were considered incidental findings and unrelated to ingestion of the test material. 29 C0179H SIGNATURES Diplomate, American College of Veterinary Pathologists (Clinical Pathology) T- / 7 - *73 bate (6329-100.Ihm) 081092 HWI 6329-100 COMMENTS ON THE DATA Various computers and computer programs were used to analyze data in this study. Because different programs round off or truncate numbers differently, values in some tables (e.g., means, standard deviations, or individual values) may differ slightly from those in other tables, from individual calculated data, or from statistical analysis data. Neither the integrity nor the interpretation of the data was affected by these differences. The test material, T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) is also referenced as FC-143 in the data for test material serum analysis. The "Study Day" for the PATHTOX computer system and the in-life data collection will always be 1 day different. The PATHTOX system considers the study initiation day as "Day 1," but for all in-life data collected manually or on a data capture system (e.g., HAZTOX), the study initiation day is "Day 0." The calculation for test material consumption is: Test material consumption (Dose Level x Food Consumption! 7 x [(Body Weight at Start of Week) (Body Weight Bain for Week + 2)] 31 G01796 HWI 6329-100 CODES, ABBREVIATIONS, AND UNITS General Codes and Abbreviations Abbreviations and Units for Clinical Chemistry Codes for Anatomical Pathology Note: The following lists of codes, abbreviations, and units are used by HWI. Some, but not necessarily all, of this information may be needed for this report. 32 0C1797 HWI 6329-100 N Mean SD; S.D.; STAND DEV A B # CV General Codes and Abbreviations Number of measurements in a group. Arithmetic mean. Standard deviation. Group mean is significantly different from the mean of the nonpair-fed control group (Group 1) at p < 0.05. Group mean is significantly different from the mean of the pair-fed control group (Group 6) at p 0.05. Not applicable; No value. Number in group. Coefficient of Variance. 33 001798 Abbreviations and Units for Clinical Chemistry Test Glucose Urea nitrogen Creatinine Total protein Albumin Globulin Albumin/globulin ratio Total bilirubin Direct bilirubin Indirect bilirubin Cholesterol High-density lipoprotein cholesterol Low-density lipoprotein cholesterol Triglyceride Uric acid Aspartate aminotransferase Alanine aminotransferase Alkaline phosphatase Gamma glutamyl transferase Sorbitol dehydrogenase Bromsulphalein clearance Lactate dehydrogenase Creatine kinase Amylase Palmitoyl CoA oxidase Calcium Inorganic phosphorus Sodium Potassium Chloride Magnesium Zinc Strontium Total carbon dioxide Bicarbonate Iron Total iron binding capacity Unbound iron binding capacity Percent iron saturation Plasma cholinesterase Red blood cell cholinesterase Brain cholinesterase Abbreviation (Units) GLU (MG/DL) UN (MG/DL) CREAT (MG/DL) T PRO (G/DL) ALB (G/DL) GLOB (G/DL) A/G RATIO T BILI (MG/DL) D BILI (MG/DL) I BILI (MG/DL) CHOL (MG/DL) HDL (MG/DL) LDL (MG/DL) TRIG (MG/DL) UA (MG/DL) AST/SGOT (IU/L) ALT/SGPT (IU/L) ALK PHOS (IU/L) GGT (IU/L) SDH (IU/L) BSP (MG/DL) LDH (IU/L) CK (IU/L) AMYL (IU/L) PCOAO (IU/G) CA (MG/DL) I PHOS (MG/DL) NA (MMOL/L) K (MMOL/L) CL (MMOL/L) MG (MEQ/L) ZN (MG/L or PPM) SR (MG/L or PPM) TCO, (MMOL/L) BICARB (MMOL/L) FE (UG/OL) TIBC (UG/DL) UIBC (UG/DL) FE %SAT (%) CHEP (MU/ML) CHER (MU/ML) CHEB (MU/ML) HWI 6329-100 Abbreviations and Units for Clinical Chemistry Test Electrophoresis Albumin Alpha-l-globulin Alpha-2-globulin Beta globulin Gamma globulin Insulin Adrenocorticotropic hormone Cortisol Glucagon Triiodothyronine Thyroxine Electrophoresis High-density lipoprotein Low-density lipoprotein Very-low-density lipoprotein Abbreviation fUnitsl E ALB (G/DL) E A-l (G/DL) E A-2 (G/DL) E BETA (G/DL) E GAMMA (G/DL) INSULIN (UU/ML) ACTH (PG/ML) CORTISOL (UG/ML) GLUCAGON (PG/ML) T3 (NG/DL) T4 (UG/DL) E-HDL (%) E-LDL (%) E-VLDL (%) 35 CQ1SO && 1-2 T U M EX NOT TAKEN MISSING UNSUITABLE AUTOLYTIC EXCLUDE BMNIX- n nF nO nM HWI 6329-100 Codes for Anatomical Pathology Definition ANIMAL OEATH CODES Interim sacrifices 1 and 2 Terminal sacrifice Postrecovery sacrifice #1 Sacrificed moribund MACROSCOPIC CODES Indicates that organ is excluded from calculations Organ weight not taken; explanation given in necropsy notes Organ missing or lost Organ technically unsuitable for weighing Organ autolytic and could not be weighed Weight has been taken, but will be excluded from all calculations MICROSCOPIC CODES Codes Prefacing Neoplastic Findings Primary, benign neoplasm Primary, malignant neoplasm Metastatic neoplasm Locally invasive neoplasm Other neoplasm (see comment) Distribution of Findings (n - Severity Gradel Not specified Focal Diffuse Multifocal 36 CQISOJt Cfldfi 1 2 3 4 5 HWI 6329-100 Codes for Anatomical Pathology Definition MICROSCOPIC COOES (Continued) Grades for Severity or Amount Minimal - the least amount of change that can be observed with the light microscope Slight - less than average amount of change, but readily discernible as abnormal Moderate - the average amount of change that 1s expected for a lesion Moderately severe (marked) - a marked amount of change with possible loss of function of the affected cells/organs Severe - a great amount of change with probable loss of function of the affected cell/organs and frequently Involves large areas of the organ 37 C01S03. HWI 6329-100 fr-0000000f\>00 Table 1 Summary of Antemortem Observations8 Observation Hunched posture Thin Malocclusion Hind legs, not used Crooked, tip of tail Stiff, tail Soft feces Few or no feces Rhinorrhea Epistaxis Alopecia Sores Back Head Neck Bloody crust Back Head Left foreleg Right foreleg Neck Right forepaw Tail Abdomen Squinting Chromodacryorrhea Swollen Both forepaws Both hind paws Left hind paw Right forepaw Tail Necrotic, tail Missing Teeth Tip of tail _o_ - L 00 00 44 00 00 00 02 00 00 00 11 9 01 01 11 02 02 01 01 33 00 00 01 00 10 00 00 00 00 00 00 01 00 T :$10 IflBSl, _10_ 30 00 00 85 00 00 00 00 00 01 11 59 10 20 11 10 21 00 00 21 01 00 00 01 01 00 00 01 00 10 00 10 00 100 1 2 6 1 1 1 1 1 0 0 13 0 0 1 0 1 1 0 3 1 1 0 0 0 1 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 a This table indicates the number of animals for which a condition was observed without regard to the specific nature, severity, reversibility, number of incidences per animal, or length of time the condition persisted. 38 C01503 HWI 6329-100 OOCVJOOOOOOO*- o o o Table 1 Summary of Antemortem Observations* Observation Hunched posture Thin Malocclusion Hind legs, not used Crooked, tip of tail Stiff, tail Soft feces Few or no feces Rhinorrhea Epistaxis Alopecia Sores Back Head Neck Bloody crust Back Head Left foreleg Right foreleg Neck Right forepaw Tail Abdomen Squinting Chromodacryorrhea Swollen Both forepaws Both hind paws Left hind paw Right forepaw Tail Necrotic, tail Missing Teeth Tip of tail 0 _L 00 00 44 00 00 00 02 00 00 00 11 9 01 a1 l1 02 02 01 01 33 00 00 01 00 10 00 00 00 00 00 00 01 00 T-5180 (ooml 30 00 00 85 00 00 00 00 00 01 11 59 10 20 11 10 21 00 00 21 01 00 00 01 01 00 00 01 00 10 00 10 00 100 1 2 7 1 1 1 1 1 0 0 13 0 0 1 0 1 1 0 3 1 1 0 0 0 1 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 a This table indicates the number of animals for which a condition was observed without regard to the specific nature, severity, reversibility, number of incidences per animal, or length of time the condition persisted. 39 GOISOV HWI 6329-100 Table 1 (Continued) Summary of Antemortem Observations* Observation Small movable tissue mass Wart-like lesion Moribund sacrifice Interim sacrifice Terminal sacrifice Recovery sacrifice _ T-5180 (oom) J L _1_ _1Q_ 100 0 10 0 3 00 10 0 100 00 0 0 10 30 30 30 30 29 30 15 15 15 15 15 15 10 10 10 10 10 NA a This table Indicates the number of animals for which a condition was observed without regard to the specific nature, severity, reversibility, number of incidences per animal, or length of time the condition persisted. 40 c o i s o t f '' 0180 6 GROUP AND DOSE LEVEL (PPM) 1 .000 2 1.000 3 10.000 4 30.000 Table 2 MEAN BODY WEIGHTS AND STANDARD DEVIATIONS (G) 13 WK DIETARY TOXICITY STUDY WITH T-51S0 HUI 6379-100 WEEK: START 1 2 3 4 S 6 7 8 9 10 11 12 13 MEAN S.D. N MEAN S D. N MEAN S.D. N MEAN S.D. N 204.1 8.89 55 206.4 10.60 55 202.8 11.16 55 203.7 10.19 55 262.5 11.14 55 264.2 14.13 55 260.2 IS.30 55 261.9 14.IS 55 312.9 14.12 55 313.4 17.52 55 302 8 24.50 55 303.6 23.04 55 351 6 16.77 S5 352 6 20.60 S5 347.4 21.60 55 346.3 21.70 55 366.2 20.68 55 368 5 23.42 55 382.6 24.89 55 380.3 26.64 55 MALES 418.6 22.35 46 418.7 25.93 43 416.9 27.24 44 407.6 28.72 45 437.7 26.48 40 440 1 26.11 40 438.2 27.85 40 426.0 29.27 40 457.3 28.60 40 460.9 29.56 40 458.2 29.71 40 447.6 30.75 40 475.2 31 11 25 476 9 28 78 25 479.3 3S.42 25 468.9 35.80 25 493 6 34 00 25 496.3 30 21 25 497 9 39.04 25 483.3 38.56 25 506.4 37.58 25 509.5 31 89 25 511 8 39.37 25 494.4 39.43 25 518.5 38 64 25 523.5 33.53 25 526.0 41.32 25 509.4 42.52 25 527.8 43.08 25 533.8 35.88 25 539 7 44.60 25 519.3 44.22 25 541 2 41.26 25 548.2 37 31 25 551 4 42 37 25 531 3 45 IS 25 Table 2 (Continued) MEAN BODY WEIGHTS AND STANDARD DEVIATIONS (G) 13 WK DIETARY TOXICITY STUDY WITH T-S180 GROUP AND DOSE LEVEL (PPM) WEEK: 14 IS 16 17 IS 19 20 21 1 .000 2 1.000 3 10.000 4 30.000 MEAN S.D. N MEAN S.D. N MEAN SO. N MEAN S D. N 530 8 44.39 10 545.9 42.79 10 570 5 50.64 10 531 3 41 55 10 540.4 43.23 10 556 3 44.05 10 510.5 54.24 10 545.3 42.70 10 549.7 47.61 10 566 4 49.45 10 590.2 55.72 10 556 9 43.51 10 559 1 48 .IS 10 575 4 51 62 10 599 8 57.49 10 566.3 45.10 10 559.7 46.53 10 578 5 52 99 10 597 .S 87.60 . 10 570.4 46.40 10 MALES 588.2 49.97 10 589.3 53.99 10 60S.6 69. OS 10 562.5 46.36 10 572.7 54.30 10 593 7 57.78 10 618.3 70.13 10 5S8.9 50.65 10 571.0 55.22 5 589.8 55.17 5 598.5 80.06 5 586 2 24.17 5 HWI 6379-100 08T0D IN) MUI 6329-100 GROUP AND DOSE LEVEL m i ..... 5 100.000 6 0.000 TABLE 2 (CONTINUED) MEAN BOOT HEIGHTS AND STANOARO DEVIATIONS (G) 13 UK DIETARY TOXICITY STUDY WITH T-5180 UEEK: MEAN SO. N MEAN SO. N START 1 2 3 4 5 6 7 8 9 10 11 12 13 HALES 204.5 11.50 55 253.3* 13.61 55 295.4a 17.44 55 328.4a 22.04 55 358.4a 27.32 54 387.5a 32.04 44 410.9a 37.09 40 432.2a 39.23 40 213.1 10.31 45 255.2 8.36 45 295.3 8.54 45 334.8 10.10 45 365.2 10.81 45 396.3 13.69 30 416.7 15.84 30 434.5 19.28 30 439.1a 46.33 25 447.8 18.06 15 454.3a 49.71 25 464.3 18.39 15 461.5a 58.70 25 470.0 18.67 15 473.2* 57.67 75 482.3 19.26 15 483.3a 61.33 25 492.9 20.50 15 494.0a 64.18 25 508.5 22.27 10 ^OSTGO u GROUP AND DOSE LEVEL (PPM) 5 100.000 6 0.000 TABLE 2 (CONTINUED) MEAN BODY WEIGHTS AND STANDARD DEVIATIONS (G) 13 WK DIETARY TOXICITY STUDY WITH T-5I80 WEEK: 14 IS 16 17 18 19 20 21 MEAN SO. N MEAN S.D. N MALES S06.2 42.93 10 516.6 43.83 10 531.6 51.67 10 536.7 48.10 10 542.0 48.84 10 550.4 51.43 10 548.9 72.78 10 523.3 77.74 5 _ _ _ - -_ -* * -*- - --- - - -- HUI 6329-100 0T8TOO 01 Table 3 MEAN BODY WEIGHT GAIN (0) 13 WK DIETARY TOXICITY STUDY WITH T-5180 HWI 6329100 GROUP AND DOSE LEVEL (PPM) WEEK 0-1 0-2 0-3 0-4 0-5 0-6 0-8 0-9 0-10 0-11 0-12 0-13 0-14 1 .000 2 1.000 3 10.000 4 30.000 MEAN SO. N MEAN S D. N MEAN S.D. N MEAN S.D. N SI 3 4.59 SS 57.1 5 53 55 57.3 5.17 55 51 2 4.93 55 101 7 9.35 55 107 1 9.75 55 99.7A 21.16 55 100.0A 19.32 55 147.4 12.70 55 146.2 13.59 55 144.4 14.31 55 142 6 14.10 55 114.0 16.76 55 182.2 16.14 55 179.6 18.20 55 176.7 20.67 55 MALES 215.0 233.9 11.16 21.67 46 40 212.7 234.0 20.57 43 22.16 40 212.1 234.0 21.11 22.40 44 40 203.2 222.0 21.92 23.92 45 40 253.5 23.10 40 254.8 25.69 40 254.1 24.54 40 243.6 25.69 40 272 5 24 04 25 271 4 24.01 25 276 0 30.54 25 264.8 30.59 25 291.0 26.75 25 290.1 25.60 25 294 5 34.01 25 279.2 33.97 25 303 7 30.21 25 304.0 27.31 25 301 5 34.20 25 290.3 34.86 25 315.8 31.59 25 318.0 28.84 25 322 7 36.43 25 305.3 38.19 25 325 2 35.86 25 328.3 31.70 25 336.3 39.83 25 315.2 40.17 25 338 5 34.06 25 342.7 33.14 25 348 1 37.78 25 327.2 42.19 25 330 I 36 IS 10 341.5 41.96 10 369.1 4190.40 329.7 37 .S3 10 ui GROUP AND DOSE LEVEL (PPM! WEEK 0-15 0-16 Table 3 (Continued) MEAN BODY WEIGHT GAIN |Q1 13 WK DIETARY TOXICITY STUDY WITH T-5110 0-17 0-1 0-1 0-20 0-21 1 .000 2 1.000 3 10.000 4 30.000 MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 340. 4 36 .3 10 351 .9 42 .15 10 37. 1 S3. 30 10 336 7 31. 96 10 349 . 1 41 .01 10 362 .1 47 .90 10 316 .7 55 .43 10 34 4 39 21 10 359 1 40 01 10 371 0 50 01 10 391 .4 57 SO 10 3S7 .8 41. 10 10 359 7 40 .06 10 374 .2 51 .42 10 396. 4 61 12 10 361 6 42. 21 10 MALES 36. 2 372.7 43 19 41.33 10 10 365 .0 369.4 S3 09 57.21 10 10 407 2 416. 69 .24 70.33 10 10 374 0 360.3 42. 61 46.56 10 10 376.. 6 SO. 30 5 364 . 8 53 .06 5 393..3 77 .07 5 376 .3 2. 25 5 HWI 6329100 fTSTOO 9 INI 6329 100 GROUP AND OOSE LEVEL iff?)..... 5 100.000 6 0 000 TABLE 3 ( c o m m u t o ) MEAN BOOT WEIGHT GAIN (G) 13 UK DIETARY TOXICITY STUDY WITH 1-5180 WEEK: HEAN S0 N MEAN S0 N 0-1 0-2 0-3 0 4 0-5 0-6 0-7 0-8 0-9 0-10 0-11 0-12 0-13 0-14 ; oB IS os ss 42 0 5 16 4S 89.0* 18.31 55 84.4 17.34 45 123.9* 17.41 55 121.7 8.73 45 153 8* 23 62 54 152.0 8 58 45 HALES 182.7* 26 43 44 206.2* 30.04 40 227.6* 32.96 40 234 9* 38.10 25 182.1 10.73 45 202.5 12.79 30 219.6 16.55 30 235 2 16.45 15 250 0* 41.43 25 251.8 16 06 15 257 2* 50 62 25 257.4 16.60 15 269.0* 49 96 25 269 8 17.07 15 279 0* 53.93 25 273 ? 24.92 15 289.7* 57 40 25 303.4 43.09 10 295.9 17.76 10 . - c o l s i A, --I GROUP AND DOSE LEVEL (PPM) 5 100.000 TABLE 3 (CONTINUED) MEAN BODY WEIGHT GAIN (G) 13 UK DIETARY TOXICITY STUDY WITH T-5180 WEEK. 0-15 0-16 0-17 0-18 0-19 0-70 0-71 MEAN SO. N 313 8 43.94 10 378.8 57.73 to 331.6 48.78 10 336.9 48.94 10 345 3 51.39 10 MALES 343.8 73.38 10 313.0 78.57 5 IMI 6329-100 T8TG0 oo GROUP ANO DOSE LEVEL (PPM) WEEK: 1 Table 4 MEAN FOOD CONSUMPTION AND STANDARD DEVIATIONS (G/WK) 13 WK DIETARY TOXICITY STUDY WITH T-S1IO 2 3 4 5 6 7 8 9 10 11 12 13 14 1 .000 2 1.000 3 10.000 4 30.000 MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 161. 10.55 54 167.2 10.95 54 166.5 12.11 53 168.6 10.67 54 160.7 13.04 S3 178.3 13.44 55 179.2 19.78 53 183.3 24.70 54 166.1 18.95 53 188.2 14.45 52 183.8 17.25 50 178.7 33.72 52 193.8 14.36 51 196.0 15.10 52 191.0 16.74 49 190.2 17.5 52 196.5 14.32 43 201.4 14.87 38 199.6 14.82 40 203.0 20.77 39 MALES 195.3 14.78 35 197.0 14.30 33 194.4 14.63 37 193. 18.11 37 192.9 14.83 39 195.4 15.81 36 194.4 14.39 39 193.0 15.69 37 188.5 17.99 24 191.5 13.13 24 189.0 14.22 23 188.8 15.53 23 193.8 16 43 24 196.8 12.20 23 193.1 16.41 24 191.9 15.81 24 189.5 16.18 24 190.4 12.41 24 190.9 15.21 23 187.3 14.15 22 184.7 20.08 23 190.2 15.77 23 189.2 15.64 24 188.9 14.99 24 183.4 20.64 22 197.2 15.73 23 168.1 15.55 22 185.6 16.73 24 180.6 14.86 20 180.5 19.17 22 181.9 16.61 23 176.6 16.68 23 175.8 16.49 6 172.2 19.08 10 191.6 17.75 9 174.6 10.39 9 o o 00 GROUP AND DOSE LEVEL (PPMI WEEK. 15 Table 4 (Continued) MEAN FOOO CONSUMPTION AND STANDARD DEVIATIONS |G/WK) 13 WK DIETARY TOXICITY STUDY WITH T-5180 1 17 18 19 20 21 1 .000 2 1.000 3 10.000 4 30.000 MEAN SO. N MEAN S.D. N MEAN SO N MEAN S.D. N 180.2 11.56 10 178.7 19.60 10 185.9 17 16 10 177.1 9.35 10 174 8 13.67 10 177.3 17.29 10 183.6 15 82 10 181.2 12.37 9 179.2 9.SO 10 176.1 21.40 10 183.9 16.46 10 183.8 9.35 9 191.4 15.78 9 191 1 17 28 10 186 3 30.04 9 189.1 8.55 9 182.4 20.45 10 187.2 19.12 10 199.1 21.95 10 193.9 8.32 9 MALES 161.8 19.48 10 182.8 20 56 10 189.6 19.12 10 169.1 9.92 9 190 5 11.90 5 198.0 25.32 5 189.1 19.69 5 192.8 11.86 5 ton GROUP AND DOSt U V U (PPM) S 100 000 6 0 000 TABLE 4 (CONTINUED) MEAN FOOD CONSUMPTION (G/WK) 13 WK DIETART TOXICITY STUOT WITH T-5180 HUI 6379-100 WEEK: 1 7 34 56 78 9 10 II 1? 13 MEAN SD N MEAN SD N 155 0* 9 54 55 153.8 7 13 45 165.1* II 36 55 164.8 0 74 44 179.3 15 59 55 178.0 4 57 43 185.3 15.76 54 183 0 4.73 43 193.1 17.76 47 187.9 10.17 73 MAIES 190 3 17 91 39 187.7 17.56 37 183.5 II 00 75 178.6 17.30 30 1818 18.48 79 176.3 9.11 14 185 7 19 78 75 179 5 8 43 15 176.5 76.75 74 171 4 6.05 17 17? 9 76.56 74 170 0 4.74 14 177 7 73.40 75 171.5 7.65 15 171.7 76 04 75 166.8 5 86 8 O O P Oh in p SN GROUP AND OOSE LEVEL (PPH) 5 100.000 TABLE 4 (CONTINUED) MEAN FOOD CONSUMPTION (G/UK) 13 UK DIETARY TOXICITY STUDY WITH T-5180 WEEK: 14 IS 16 17 18 19 20 21 MEAN SO N 164.8 22.52 10 178.8 19.02 10 176.0 22.12 10 172.6 18.40 10 178.8 17.16 10 MALES 177.6 16.15 10 164.5 41.88 10 174.9 15.95 10 HU I 6329-100 001S1 uii GROUP AND DOSE LEVEL (PPM) WEEK: 1 .000 2 1.000 3 10.000 4 30.000 MEAN SD N MEAN SO. N MEAN SO. N MEAN S.D. N Table 5 MEAN COMPOUND CONSUMPTION (MG/KG/DAY | 13 WK DIETARY TOXICITY STUDY WITH T-5180 HWI 6329-100 1 00 .00 54 .09 00 54 .91 .04 53 2 75 .10 54 2 00 .00 53 .01 .00 55 .15 .13 53 2.59 .33 54 34 .00 00 53 01 00 52 .75 .05 50 2 20 .39 52 .00 .00 51 .07 .00 52 .71 .03 49 2.14 .15 52 5 MALES .00 00 43 .07 .00 39 .61 .03 40 2.13 IS 39 6 .00 .00 35 .06 .00 33 .63 .03 37 1.96 .13 37 7 .00 00 38 06 00 36 60 .02 39 1 85 08 37 8 .00 00 24 06 00 24 56 02 23 1 72 .07 23 9 .00 00 24 06 00 23 .56 .03 24 1.71 .08 24 10 .00 00 24 .05 00 24 53 02 23 161 07 22 11 00 00 23 05 00 23 51 02 24 1 $8 07 24 12 00 00 22 05 00 23 50 02 22 1 52 08 24 #TSTGD cn Ui coisf^ GROUP AND DOSE LEVEL (PPM| WEEK: 13 1 000 2 1.000 3 10 000 4 30.000 MEAN SD N MEAN SD N MEAN SO N MEAN S D. N .00 00 20 .05 .00 22 .47 03 23 1.44 10 23 Table 5 (Continued) MEAN COMPOUND CONSUMPTION (MG/KG/DAY) 13 WK DIETARY TOXICITY STUDY WITH T-51D0 HVI 6329-100 INI 6329-100 TABLE 5 (CONTINUED) MEAN COMPOUND CONSUMPTION (MG/KG/DAV) 13 UK DIETARY TOXICITY STUDY WITH T-5180 i GROUP ANO OOSE LEVEL (PPM) WEEK: 17 3 4 56 78 9 10 II 12 13 5 100.000 6 0.000 MEAN SO. N MEAN SO. N 6.75 0.34 55 .00 .00 45 7.99 0.35 55 .00 .00 45 7.80 0.43 55 .00 .00 45 7.39 0.40 54 .00 .00 45 7.13 0.38 42 .00 .00 30 HALES 6.64 0.36 39 6.21 0.32 37 .00 .00 30 .00 .00 30 5.88 0.35 25 .00 .00 15 5.84 0.39 25 .00 .00 15 5.46 0.47 24 .00 .00 IS 5.23 0.48 24 .00 .00 15 5.25 0.41 25 .00 .00 15 4.97 0.43 25 .00 .00 9 o 00-> K) cinn t" i 6 UO)1 09 14 DOSE PPM Table 6 SUMMARY OF CLINICAL CHEMISTRY DATA MALES WEEK S PCOAO IU/Q 0 MEAN SO. N 1 MEAN S.D. N 10 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 0 MEAN S.D. N 1 S 5 9 17 5 A 14 3.6 S 24 A 11.4 5 AB 37 14.6 5 .4 5 HWI 632B100 2P28T00 i cn --l DOSE PPM Table 7 SUMMARY OF CLINICAL CHEMISTRY DATA MALES WEEK I PCOAO IU/Q (AN SO. N (AN SO. N MEAN SO. N MEAN S.D. N MEAN S.D. N MEAN S.D. N 7 15 5 71 5 16 5.5 5 32 A 12.2 5 AB 54 35.3 5 7 1.5 5 HWI 6320100 J^BTGO DOSE PPM Table 8 SUMUftY OF CLINICAL CHEMISTRY DATA MALES WEEK 14 PCOAO IU/Q 0 MEAN SO. N 1 MAN SO. N 10 MEAN SO. N 30 MEAN SO. N 100 MEAN SO. N 0 MEAN SO. N 6 .0 s 1.0 5 10 2.1 5 14* 3.4 S AB 17 4.5 S 5 1.1 5 uC Dt HWI 6320100 rzsToo DOSE PPM Table 9 SUMMARY OF CLINICAL CHEMISTRY DATA MALES WEEK 22 PCOAO IU/Q 0 MEAN SD N 1 MEAN SO. N 10 AN S D. N 30 MEAN SO. N 100 MEAN SD N 7 7 5 7 1 5 7 11 S 71. 1 S 7 .4 5 i\on HWI 6329100 HAZLETON LABORATORIES AMERICA, INC. MADISON. WISCONSIN U S A . TABLE 10 SUMMARY OF ABSOLUTE ORGAN WEIGHT DATA (G| S WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL;WEEKS-ALL DEATH-1;SUBSET-ALL SEX GROUP NUMBER -- 1-- IS .......MALE 15 IS 15 14 IN GRP. MEAN STAND DEV 15 411 1 21.7 >>> TERMINAL BODY WEIGHT 19) <<< 15 15 15 14* 413.9 398.4 403.3 378.4 34.5 32.0 35.5 18.4 IN GRP. MEAN STAND DEV IS 2.0732 .0812 >>> BR - BRAIN <<< 15 15 15 2.0275 2.0452 2.0604 .0842 .0966 .0759 14 2.0437 .0996 IN GRP. MEAN STAND DEV IS 16.3401 2.1378 >>> LI - LIVER <<< 15 15 15A IS 4495 17 8942 23.2303 1.7139 2.1294 2.8382 14 A B 25.4377 1.9900 IN GRP. MEAN STAND DEV 15 1 5138 .2006 >>> LU - LUNG <<< 15 15 1.5312 1.4426 .0989 .1122 15 1.4932 .1231 14 1.4140 .0828 IN GRP. MEAN STAND DEV 15 1.6442 .1250 >>> TEO - LF. TESTIS <<< 15 IS 15 1 6222 1 6454 1.5874 .1410 .1241 .0916 14 1.5794 .1704 15 15 388.9 11.1 15 2.0172 .0857 15 15.8344 1.1305 15 1.5376 .1266 15 1.6102 .1234 r> Q GO o HWI 6329-100 PRINTED. 1S-OCT-91 TABLE.PAGE: 10.1 ^,28T00 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . 10TABLE SUMMARY OF ABSOLUTE ORGAN WEIGHT DATA (Q| 5 WEEK SACRIFICE TABLE INCLUDES: SEX.ALL;GROUP-ALL;WEEKS-ALL DEATH*!;SU8SET*ALL I 11 It i1 1 *| 11 SEX: GROUP: NUMBER: -- 1 --IS 15 ..... MALE--3........ IS A IN GRP.. MEAN: STAND DEV: IS 1.8523 .1273 >>> TE1 - RT. TESTIS <<< 15 IS 15 1.8169 1.6520 1.5904 .1243 .1059 .1095 IN G R P .: MEAN. STAND DEV. 15 2.6101 2257 >>> SO - ACCESS/SEX ORG <<< 15 15 15 2.6799 2.9350 2.6973 .3592 .4096 .3136 14 1.6260 .1013 14 2.6319 .2549 1 1 1 11 <1 1 1*> 1 1 4 11 11 1 15 15 1.6001 .1212 15 2.4999 .3579 HW1 6329-100 PRINTED: 15-OCT-91 TABLE PAGE: 10 2 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN US.A. TABLE 11 SUMMARY OF ABSOLUTE ORGAN WEIGHT DATA (G| 1 WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL;WEEKS-ALL DEATH-2;SUBSET-ALL SEX GROUP NUMBER IS .......MALE 15 15 15 15 IN GRP MEAN STAND DEV IS 473.1 26.0 >> IS TERMINAL BODY WEIGHT 15 15 (9) 1<5<< 414.0 470.9 466.9 459.0 36.6 21.6 21.7 34.2 IN GRP. MEAN STAND DEV IS 2.0923 .0896 >>> 6R - BRAIN <<< IS 15 15 2.0739 2.0152 2.1032 .0649 0>S1 .0650 15 2.0S5 .010 IN GRP. MEAN STAND DEV 15 17.7610 2.1244 >>> LI - LIVER <<< IS IS 15 A 17 679 19.4195 24.0114 2.7374 2.0972 3.579 15 A B 27 7557 3.5077 IN GRP. MEAN STAND DEV IS 1.5*29 .1077 >> LU - LUNG <<< 15 15 1.617 1 5339 .1110 .1297 15 1.4902 .1217 15 1.5201 .1904 IN GRP. MEAN STANO DEV 15 1 6101 .1110 >>> TEO - IF. TESTIS <<< IS 15 15 1 6166 1.6664 1.7163 .0121 .2296 .1649 15 1.6115 .1265 -- 6 --15 15 449.3 24.9 IS 2.0162 .0907 15 16.907 2.2232 15 1.5615 .1317 15 1.6305 .1177 r> 05 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 11.1 HAZLETON LABORATORIES AMERICA, INC. MADISON. WISCONSIN U.S.A. TABLE 11 SUMMARY OF ABSOLUTE ORGAN WEIGHT DATA (Gl I WEEK SACRIFICE TABLE INCLUDES: SEX-ALL:GROUP-ALL:WEEKS-ALL DEATH-2;SUBSET-ALL SEX GROUP: NUMBER: 15 ---2--15 ..... MALE--3........ -4--- IS 15 ---5 -- 15 IN GRP.: MEAN: STAND DEV: 15 1.7036 .1052 >>> TEI - RT. TESTIS <<< IS 15 15 1.6675 1.6904 1.7911 .1076 .1397 .2401 15 1.6533 .1070 IN GRP.: MEAN: STAND DEV: 15 3.0673 .3617 >>> SO - ACCESS/SEX ORG <<< 15 IS IS IS 3.0990 3.4446 3.1306 2.6513 .4021 .3649 .3164 .2775 15 14 1.6335 .1111 IS 2.6606 .4391 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 11.2 r> Ol p00 M HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 12 SUMMARY OF ABSOLUTE ORGAN WEIOHT DATA (G) 14 WEEK SACRIFICE TABLE INCLUDES. SEX-ALL GROUP.ALL ;WEEKS-ALL DEATH-T;SUBSET-ALL SEX .......MALE GROUP NUMBER IS 15 15 15 IS is 1 IN GRP MEAN STAND DEV 15 55. 7 41.1 >>> TERMINAL BODY WEIGHT 14 15 15 (9) 1<4<< 555.1 552.7 53. 2 489.1 42.0 40.7 58.1 79.0 15 503.5 23.7 IN GRP. MEAN STAND DEV 15 2.1914 .1183 >>> BR - BRAIN <<< 14 15 15 2.2279 2.1740 2.1011 .2745 .0196 .0724 14 2.1342 .1044 15 2.1364 .0594 IN GRP. MEAN STANO DEV 15 19 7299 2 2290 >>> LI - LIVER <<< 14 15 15 IS.0355 20 4416 22.7367 2 1120 2 1657 4.2121 14 A B 26.7846 5.4675 15 16.3033 1.6241 IN GRP. MEAN STAND DEV 8 IN GRP. MEAN STAND DEV 15 1 6543 1403 15 1 7591 .1174 >>> LU - LUNG <<< 14 15 1.6001 1.5803 .1166 .2250 15 1.6101 .1316 >>> TEO - LF. TESTIS <<< 14 15 15 1 7329 1.7767 1.7771 .2279 .1017 .1216 14 1 5123 .1401 15 1.5875 .1018 14 1.7576 .1547 15 1 7117 .1381 HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 1 2 1 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 12 SUMMARY OF ABSOLUTE ORGAN WEIGHT DATA (G| 14 WEEK SACRIFICE TABLE INCLUDES: SEXALL.GROUPALL.WEEKS-ALL OEATHT;SUBSET-ALL SEX GROUP NUMBER IS ....... M A L E - - 3 ......... -4-.. --5--- IS IS 15 15 IN G R P . MEAN STAND DEV IS 1.7572 .112 >>> TE1 14 1.9269 .2499 - RT. T E ST IS <<< 15 15 1.7519 1.7759 .0772 .1197 14 1.7373 .1460 IN GRP. MEAN STAND DEV 15 3.5217 .4974 >>> S O - AC CE S S / S E X O R G <<< 14 15 15 3.4797 3.5435 3.3760 .429 .5535 .4792 14 3.3647 .6309 ---6 -- 15 15 1.6903 .1204 15 3.2597 .6635 HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 12.2 coisap A<nn 0183 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 13 SUMMARY OF ABSOLUTE ORGAN WEIGHT DATA |G) 22 WEEK SACRIFICE TABLE INCLUDES: SEX*ALL:GROUP*1.2,3,4,5,WEEKS-ALL 0EATH*U;SUBSE TALL G NU RMOBSEUEXPR::: ---1--10 --2--10 --MALE------ ---3--- ---4--10 10 10 IN GRP.. MEAN: STAND DEV: 10 57 1 61.6 > > > TERMINAL BOOY WEIGHT ( g ) < < < 10 10 10 10 607 1 SI 1 129.2 73.4 601.1 51.2 55696..0a IN ORP.: MEAN: STANO DEV. >>> BR - BRAIN <<< 10 10 A 10 2.1321 2 2465 2.2042 .0622 .0496 .0774 10 2.1122 .0163 10 2.1345 .0909 M IN E GRP AN . :: STAND DEV: > > > LI - LIVER < < < 10 10 10 IS.6432 It 4373 11.9203 3.0(67 1.7410 2.2968 10 20 7334 1.1916 10 11.6190 2.4465 IN GRP.: MEAN: STAND DEV: > > > LU - LUNG < < < 10 10 10 1.5961 1 7415 1.6100 .1050 1S4S .1127 10 1.6937 .1476 10 1.5919 .1130 aM IEN AGRNP.: : STAND DEV >>> TEO - LF . TESTIS c < < 10 10 10 10 1.6934 1.7559 1.739 1 7055 .1536 .1607 .2194 .2248 10 1.7590 .1509 <n o HWI 6329-100 PRINTED: ll-OCT-91 TABLE PAGE: 1 3 1 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 13 SUMMARY OF ABSOLUTE ORGAN WEIGHT DATA (G) 22 WEEK SACRIFICE TABLE INCLUOES: SEX*ALL;GROUP1.2,3.4.5;WEEKS-ALL DA7H*U;SUBSET-ALL SEX: GROUP: -- 1--- NUMBER. 10 ---2--10 -MALE----3--- 10 10 IN GRP : MEAN: STANO DEV: >>> TE1 - RT. TESTIS <<< 10 10 10 10 1 7544 ' 1.7592 1.7991 1.7913 1811 .1739 .1134 .1655 IN GRP.: MEAN STAND DEV: >>> SO - ACCESS/SEX ORG <<< 10 10 10 10 3 5540 3 6512 3.5191 3.9577 5410 .5401 .2931 .4056 10 1.7355 .1118 10 3.6939 .6923 HWI 6329-100 PRINTED: ll-OCT-91 TABLE PAGE 13 2 tfDSTGO O*~i4 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A . TABLE 14 SUMMARY OF ORGAN-TO-BOOY WEIGHT PERCENTAGES 5 WEEK SACRIFICE TABLE INCLUDES: SEX-ALL :GROUP-ALL;WEEKS-ALL DEATH-1 :SUBSET-ALL SEX GROUP NUMBER IS ..... MALE IS 15 15 IN GRP. MEAN STAND DEV IS .5053 .0260 >>> BR - BRAIN <<< 15 IS 15 .4927 .5162 .5142 .0416 .0474 .0444 IN GRP. MEAN STAND DEV 15 3.9690 .3714 >>> LI - LIVER <<< 15 ISA 15 A 3.7297 4.4146 5.7612 .2293 .3162 .6020 9 IN GRP. MEAN STAND DEV 15 .3676 .0413 >>> LU - LUNG <<< 15 15 .3710 .3625 .0216 .0162 15 .3713 .0271 IN ORP. MEAN STAND DEV 15 .4007 .0332 >>> TEO - LF. TESTIS <<< 15 15 15 .3933 .4142 .3962 .0350 .0310 .0391 IN GRP. MEAN STAND DEV IS .4025 .0309 >>> TEI - RT. TESTIS <<< 15 15 15 .3922 .4160 .3944 .0350 .0290 .0414 14 IS 14 .5409 .0305 15 .5199 .0207 14 A B . 15 6.7292 4.0714 .4939 .2734 14 .3739 .0191 IS .3955 .0319 14 .4179 .0475 IS .4139 .0299 14 .4309 .0359 15 .4113 .0274 O O P GO HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 14.1 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 14 SUMMARY OF ORQAN-TO-BODY WEIGHT PERCENTAGES S WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL ;WEEKS-ALL DEATH-1.SUBSET-ALL SEX: GROUP: NUMBER 15 ...... MAL E... ..... ...4 ... 15 15 15 IN GRP.. MEAN. STAND DEV: 15 .6530 .0545 >>> SO 15 .6472 .0857 ACCESS/SEX 15 IOSRQ <<< .7122 .6710 .0910 .0769 14 14 .6956 .0579 ---6-~ 15 15 .6409 .0943 HWI 6329-100 PRINTED: U-OCT-91 TABLE.PAGE: 14.2 __^trSTOD HAZLETON LABORATORIES AMERICA, INC. MADISON. WISCONSIN U S A. TABLE 15 SUMMARY OF ORQAN-TO-BODY WEIGHT PERCENTAGES 1 WEEK SACRIFICE TABLE INCLUDES: SEX-ALL GROUP-ALL ;WEEKS-ALL DEATH-2;SUBSET-ALL SEX: GROUP NUMBER ........................... MALE --3--- --4--- 15 IS IS 15 IN GRP. MEAN STAND DEV 15 .4436. .0311 >>> BR - BRAIN <<< 15 15 IS .4304 .4445 .4519 .0294 .0349 .0274 IN GRP. MEAN STAND DEV 15 3.7451 .2450 >>> LI - LIVER <<< 15 15 15 A 3.6394 4 1240 5.1344 .3334 .3702 .5317 IN GRP. MEAN STANO DEV 15 .3352 .0249 >>> LU - LUNG <<< IS 15 .3355 .3261 .0241 .0246 15 .3194 .0271 IN GRP. MEAN STAND DEV 15 .3561 .0291 >>> TEO - LF. TESTIS <<< IS 15 15 .3501 .3536 .3642 .0243 .0429 .0342 IN GRP. MEAN STAND DEV 15 .3609 .0254 >>> TEI - RT. TESTIS <<< 15 15 15 .3503 .3592 .3451 .0323 .0242 .0594 15 15 .4565 .0374 15 A B 6.0547 .7149 15 .3321 .0415 15 .3899 .0404 15 .3620 .0342 IS 15 .4654 .0292 15 3.7544 .3705 IS .3443 .0325 15 .3636 .0279 14 .3641 .0254 HUI 6329-100 PRINTED: U-OCT-91 TABLE.PAGE : 15.1 ^ etstoo HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 15 SUMMARY OF ORGAN-TO-BODY WEIGHT PERCENTAGES I WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL;WEEKS-ALL DEATH-2.SUBSET-ALL SEX GROUP NUMBER ---1--15 ---2--15 .......MALE---3........ . 4 . . . 15 15 --5--15 IN GRP. MEAN STAND DEV 15 .6471 .0557 >>> SO - ACCESS/SEX ORG <<< 15 15 IS 15 .6419 .7340 .6720 .6225 .0139 .0900 .0725 .0562 -- 1-- 15 IS .6439 .1090 HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE 1 5 2 C8T0.3 HAZLETON LABORATORIES AMERICA. INC MADISON. WISCONSIN U S A. T A B U 16 SUMMARY OF ORGAN-TO-BODY WEIGHT PERCENTAGES 14 WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL;WEEKS-ALL DEATH-T,SUBSET-ALL SEX GROUP ---2--- --3--- -.4 ... NUMBER 15 15 15 15 IN GRP. MEAN STAND DEV 15 .3944. .0377 >>> BR - BRAIN <<< 14 15 15 .4037 .3951 .3954 .0613 .0296 .0401 IN GRP. MEAN STAND DEV 15 3.5293 .2101 >>> LI - LIVER <<< 14 A 15 15 A 3 235* 3.61*3 4.2106 .3001 .323* .5609 IN GRP. MEAN STAND DEV 15 .2961 .0239 >>> LU - LUNG <<< 14 15 .2192 .2*56 .0329 .0329 15 .3016 .034* IN GRP MEAN STAND DEV 15 3162 0292 >>> TEO - L F . TESTIS <<< 14 15 IS 3124 .3234 3327 .0366 .0343 .0322 IN GRP MEAN STAND DEV 15 .3160 .0296 >>> TE1 - RT. TESTIS <<< 14 15 15 3295 .31*9 .3325 .0392 .0305 .0321 15 15 14 .4466 .0713 15 .4250 .0111 14 A B 15 5.4947 . 3.2347 .1403 .2274 14 .3136 .0357 15 .3159 .0247 14 A .3653 .0416 15 .3400 .0224 14 A .3610 .0464 15 .3360 .0216 N HWI 6329-100 PRINTED: 11-OCT-91 TABLE.PAGE : 16.1 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A TABLE 16 SUMMARY OF ORGAN-TO-BOOY WEIGHT PERCENTAGES 14 WEEK SACRIFICE TABLE INCLUDES: SEX-ALLGROUP-ALL:WEEKS-ALL DEATH-T;SUBSET-ALL SEX: E..... --- GROUP: NUMBER: 15 15 1S 15 IN GRP . MEAN: STAND DEV: 15 .6327 .0937 >>> 14 SO - ACCESS/SEX ORG IS 15 <<< .6273 .6454 .6361 .0641 .1221 .1240 IS 14 .6910 .0946 -- Q-15 15 .6470 .1241 HWI 6329-100 PRINTED. ll-OCT-91 TABLE.PAGE : 16.2 G0183 CJ COIS HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 17 SUMMARY OF ORQAN-TO-BOOY WEIGHT PERCENTAGES 22 WEEK SACRIFICE TABLE INCLUDES: SEX-ALLGROUP-ALL :WEEKS-ALL DEATH-U;SUBSET-ALL SEX ..... MALE GROUP -- -1-- NUMBER 10 10 10 10 8 IN GRP. MEAN STAND DEV 10 .3720 .0336 >>> 8R - BRAIN <<< 10 10 10 .3727 .3543 .3647 .0311 .0397 .0320 IN GRP. MEAN STAND DEV 10 3.2077 .1976 >>> LI - LIVER <<< 10 10 10 3.0416 3.0160 3.4661 .1717 .2676 .4276 IN GRP. MEAN STAND DEV 10 .2776 .0117 >>> LU - LUNG <<< 10 10 .2675 .2701 .0169 .0406 10 .2621 .0214 IN GRP. MEAN STAND DEV 10 .2946 .0261 >>> TEO - LF. TESTIS <<< 10 10 10 .2904 .2761 .2850 .0266 .0345 .0431 IN GRP. MEAN STAND DEV 10 .3054 .0357 >>> TEI - RT. TESTIS <<< 10 10 10 .2912 .2674 .2996 .0306 .0259 .0375 10 10 .3904 .0624 10 3.3642 .3538 10 .2906 .0447 10 .3210 .0499 10 .3167 .0455 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 17.1 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 17 SUMMARY OF ORGAN-TO-BOOY WEIGHT PERCENTAGES 22 WEEK SACRIFICE TABLE INCLUDES: SEX>ALL:GROUP*ALL ;WEEKS-ALL DEATH*U;SUBSETALL SEX .......MALE- GROUP ---2--- ---3........ -4--- --5--- NIMBER 10 10 10 10 10 9 IN GRP. MEAN STAND DEV 10 .6145 .0714 >>> SO - ACCESS/SEX ORG <<< 10 10 10 .6057 .5714 .6590 .0919 .0179 .0594 10 .6792 .1950 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 17.2 VT90 in HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A . TABLE 11 SUMMARY OF ORGAN-TO-BRAIN WEIGHT RATIOS 5 WEEK SACRIFICE TABLE INCLUDES. SEX-ALL;GROUP*ALL;WEEKS-ALL DEATH-1;SUBSET-ALL SEX GROUP NUMBER -- 1-- 15 -- 2-15 ..... MALE --4-- 15 15 IN GRP. MEAN STAMI DEV 15 1 0000 .0000 >>> BR - BRAIN <<< 15 15 15 1.0000 1.0000 1.0000 .0000 .0000 .0000 IN GRP. MEAN STAND DEV 15 7.1102 .9350 >>> LI * LIVER <<< 15 15 ISA 7.6323 1 7711 11 2764 .9170 1.1310 1.3499 IN GRP. MEAN STAND DEV 15 .7309 .0969 >> LU - LUNG <<< 15 15 15 .7564 .7063 .7242 .0575 .0573 .0452 IN GRP. MEAN STAND DEV 15 .7932 .0541 >>> TEO - LF. TESTIS <<< 15 15 15 .1015 .1064 .7713 .0794 .0739 .0513 IN GRP. MEAN STAND DEV 15 .7971 .0562 >>> TEI - RT. TESTIS <<< 15 IS 15 .7990 .1095 .7679 .0742 .0644 .0510 -- 5 -14 14 1.0000 .0000 14 A B 12.4713 1 0996 14 .6925 .0313 14 .7734 .0152 14 .7971 .0604 15 15 1.0000 .0000 15 7.1656 .6950 15 .7631 .0659 IS .1000 .0767 15 .7951 .0771 o> HWI 6329-100 PRINTED. 11-OCT-91 TABLE.PAGE: 11.1 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN US.A. TABLE II SUMMARY OF ORGAN-TO-BRAIN WEIGHT RATIOS S WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL:WEEKS-ALL DEATH-1;SUBSET-ALL SEX: GROUP: NUMBER: 1S -- 2--IS ...... MAL E ......... 15 15 IN G R P .: MEAN: STAND DEV. IS 1.2925 .091 >>> SO IS 1.3224 .1743 ACCESS/SEX ORG <<< 15 IS 1.3897 1.3098 .2163 .1497 14 14 1.2900 .1321 15 IS 1.2333 .1678 HWI 6329-100 PRINTED: 11-OCT-B1 TABLE.PAGE: 11.2 or> 05 v4 r 0184 HAZLETON LABORATORIES AMERICA, INC. MADISON. WISCONSIN U S A . TABLE 10 SUMMARY OF ORQAN-TO-BRAIN WEIGHT RATIOS I WEEK SACRIFICE TABLE INCLUOES: SEX-ALL;GROUPALL;WEEKS-ALL DEATH-2;SUBSET-ALL SEX GROUP --4-- NUMBER 15 15 15 15 IN GRP. MEAN STAND DEV 15 1.0000' .0000 >>> BR - BRAIN <<< 15 15 15 1.0000 1.0000 1.0000 .0000 .0000 .0000 IN GRP MEAN STAND DEV 15 1.4990 1.0685 >>> 15 LI - LIVER 15 <<< 15A 8 5253 9.3301 11.4408 1.2877 1.1031 1.5808 IN GRP. MEAN STAND DEV 15 .7571 .0536 >>> LU - LUNG <<< 15 15 .7799 .7377 .0455 .0795 15 .7083 .0518 IN GRP. MEAN STAND DEV 15 .1042 .0614 >>> TEO - LF. TESTIS <<< 15 15 15 .8136 .8004 .8172 .0395 .1154 .0864 IN GRP. MEAN STAND DEV 15 .1153 .0601 >>> TE1 - RT. TESTIS <<< 15 15 15 .8140 .8117 8543 .0517 .0727 1342 ---5 -- 15 15 1.0000 .0000 ISA B 13.3008 1.5175 15 .7295 .0929 15 .8111 .0722 15 .7939 .0604 15 15 1.0000 .0000 15 8.1178 1.1411 15 .7485 .0556 15 .7831 .0672 14 .7823 .0727 CD HWI 6329-100 PRINTED: U-OCT-91 TABLE.PAGE. 19.1 HAZLETON LABORATORIES AMERICA, INC. MAOISON, WISCONSIN U S A . TABLE IB SUMMARY OF ORQAN-TO-BRAIN WEIGHT RATIOS I WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUPALL;WEEKS-ALL DEATH-2;SUBSET-ALL SEX: GROUP: NUMBER: 15 ....... MAL E......... ---5 -- - 15 15 1S IS IN GRP. : MEAN: STAND DEV: IS 1.4672 .1710 >>> SO IS 1.4939 .1163 ACCESS/SEX ORG <<< 15 15 1.6524 1.4905 .1631 .1662 IS 1.3695 .1361 15 IS 1.3164 .2390 HWI 6329-100 PRINTED: U-OCT-91 TABLE.PAGE: 1 9 2 O o %o 4 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A. TABLE 20 SUMMARY OF ORGAN-TO-BRAIN WEIGHT RATIOS 14 WEEK SACRIFICE TABLE INCLUDES: SEX*ALL;GROUP-ALL;WEEKS-ALL DEATHT;SUBSET-ALL SEX GROUP NUMBER IS ......MALE IS 15 15 IN GRP. MEAN STAND DEV IS 1.0000 .0000 >>> BR - BRAIN <<< 14 15 15 1.0000 1.0000 1.0000 .0000 .0000 .0000 IN GRP. MEAN STAND DEV 15 9.0327 1.2007 >> LI - LIVER <<< 14 15 IS 6.1901 9 4115 10.7811 1.5593 1.3310 1.9614 IN GRP. MEAN STAND DEV IS .7557 .0609 >>> LU - LUNG <<< 14 15 .7259 .7264 .1075 .0962 15 .7632 .0496 IN GRP. MEAN STAND DEV IS .1053 .0723 >>> TEO - LF. TESTIS <<< 14 15 15 .7644 .6191 .8430 .1209 .0655 .0498 IN GRP. MEAN STAND DEV 15 .1044 .0701 >>> TE1 - RT. TESTIS <<< 14 15 15 .6300 8074 .8428 .1526 .0532 .0555 -.-5 -- 15 14 1.0000 .0000 14 A B 12.6121 2.6823 14 .7096 .0686 14 .8255 .0849 14 .8154 .0759 15 15 1.0000 .0000 15 7.6352 .7740 IS .7433 .0482 15 .8008 .0544 15 .7908 .0441 HW1 6329-100 PRINTED: 15-OCT-fll TABLE.PAGE : 20.1 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A. TABLE 20 SUMHARY OF ORGAN-TO-BRAIN WEIGHT RATIOS 14 WEEK SACRIFICE TABLE INCLUDES: SEX*ALLGROUP'ALL;WEEKSALL DEATH-T;SUBSET.ALL SEX: GROUP: NUMBER: IS -- -2--is IN GR P.. MEAN: STAND DEV: 15 1.6064 .2047 >>> SO 14 1.5795 .2402 E ........ ...4 ... 15 15 ACCESS/SEX ORG <<< 15 15 1.6211 1.6014 .2354 .2191 15 14 1.5140 .3327 15 15 1.5261 .3019 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 20 2 C0184 09 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A . TABLE 21 SUMMARY OF ORQAN-TO-BRAIN WEIGHT RATIOS 22 WEEK SACRIFICE TABLE INCLUDES: SEX-ALL:GROUP-ALL;WEEKS-ALL DEATH-U,SUBSET-ALL SEX GROUP NUMBER -- 1-- 10 -- 2--10 --3......... 4--10 10 IN GRP. MEAN STAND DEV 10 1.0000 .ooop >>> BR - BRAIN <<< 10 10 10 1.0000 1.0000 1.0000 .0000 .0000 .0000 IN GRP. MEAN STAND DEV 10 7277 1.3117 >>> LI - LIVER <<< 10 10 10 2047 I.Stll 9.5071 .7112 1.0599 .<621 9 IN GRP. MEAN STAND DEV 10 .7490 .0512 >>> LU - LUNG <<< 10 10 .7751 .7626 .0645 .0135 10 .7763 .0611 t IN GRP. MEAN STAND OEV 10 .7952 .0799 >>> TEO - LF. TESTIS <<< 10 10 10 .715 .7903 .7S2I .0610 1042 .1097 IN GRP. MEAN STAND DEV 10 .1243 .0966 >>> TE1 - RT. TESTIS <<< 10 10 10 7130 (161 .1229 .0746 .0152 .0917 10 10 1.0000 .0000 10 (.7300 1.1471 10 .745 .0434 10 .1242 .0627 10 .1140 .0563 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 21.1 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U.S.A. TABLE 21 SUMMARY OF ORGAN-TO-BRAIN WEIGHT RATIOS 22 WEEK SACRIFICE TABLE INCLUDES. SEX-ALL;OROUP-ALL;WEEKS-ALL OEATH-U;SUBSET-ALL SEX: GROUP: NUMBER: I11 I11i-111*o 1t 11 ---2--10 ...... MAL E......... ---3--- 10 10 IN GRP. : MEAN : STAND DEV. 10 1.6634 .2255 >>> SO - ACCESS/SEX ORG <<< 10 10 10 1.6271 1.6320 1.6151 .2294 .1649 .1973 10 10 1.7299 .3199 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 2 1 2 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A . TABLE 22 INCIDENCE OF MACROSCOPIC OBSERVATIONS S WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;CROUP-ALL;WEEKS-ALL DEATH-1:SUBSET-ALL ORGAN AND KEVWORD(S) OR PHRASE ** TOP OF LIST * GENERAL COMMENT (GC| ........ -- N U M B E R -O F -A N SEX: GROUP: -1NUMBER: IS 15 15 15 14 IS NUMBER EXAMINED: 15 15 IS IS 14 15 ALL TISSUES/ORGANS NORMAL 14 13 14 13 11 13 BRAIN (8R) ............................................ NUMBER EXAMINED: 15 IS 15 15 14 15 NOT REMARKABLE: 15 IS IS 15 14 15 LUNG fLU) ............................................. NUMMBBEERR' EXAMINED. 15 15 15 15 14 IS NOT REHARKA8LE: IS 15 15 15 14 15 LIVER (LI) ............................................ NUMBER EXAMINED: 15 IS IS 15 14 IS NOT REMARKABLE: 15 15 15 15 14 IS LF. TESTIS (TEO) . CONTAINS FLUID PROSTATE (PR) ... NODULAR ........................... ......................... NUMBER EXAMINED: 15 15 15 15 14 IS NOT REMARKABLE: 15 15 IS 15 13 15 000 0 10 NUMBER EXAMINED: IS 15 IS 15 14 IS NOT REMARKABLE: 15 15 15 15 14 14 00000 1 o 00 HWI 6329-100 PRINTED: 1S-OCT-91 TABLE.PAGE: 22.1 (fSSTQO HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A . TABLE 22 INCIDENCE OF MACROSCOPIC OBSERVATIONS 5 WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL:WEEKS-ALL DEATH-1:SUBSET.ALL ORQAN AND KEYWORD(S) OR PHRASE .......... ...... *----------SEMINAL VESICLE (SV) ......... ....................... -- NUM BER -0 F -A N SEX: ---MALE--- GROUP: -1- -2- -3- -4- -5- -6- NUMBER: --IS-- -15- -1m5- -15-- -14-- -15- NUMBER EXAMINED: 15 15 15 15 14 IS NOT REMARKABLE: 15 15 15 IS 14 15 COAGULATING GLD (CGI ......... ....................... NUMBER EXAMINED: 15 15 15 15 14 15 NOT REMARKABLE: 15 IS 15 15 14 IS URETHRA (UR) .................. ....................... NUMBER EXAMINED: IS 15 15 15 14 15 NOT REMARKABLE. 15 15 15 IS 14 15 SKIN (SKI ..................... ....................... NUMBER EXAMINEO: IS 15 IS 15 14 15 NOT REMARKABLE: 15 IS 14 15 14 IS CRUSTED AREA(S) 00 100 0 KIDNEY(S) (KD) ............... ....................... NUM8ER EXAMINED: 15 15 15 15 14 15 NOT REMARKABLE: 14 13 15 13 11 14 LARGE PELVIS(ES) SEMIFLUID MATERIAL-PELVIS 12023 1 0000 10 SPLEEN (SP| ................... ................. NUMBER EXAMINED: 15 15 15 IS 14 15 NOT REMARKABLE: 15 15 15 14 14 15 RAISED FOCUS)I(/AREA(S) 000 10 0 oo in HWI 6329-100 PRINTED: 15-0CT-91 TABLE.PAGE: 22.2 HAZLETON LABORATORIES AMERICA, INC. MADISON, WISCONSIN U S A . TABLE INCLUDES: SEX*ALL;GROUPALL;WEEKSALL DEATH!;SUBSET-ALL ORGAN AND KEYWORD!S) OR PHRASE MESENTERIC LN (MS) ......... MANDIB/CERV LH (MN) ........ LUMBAR/ILIAC LN |LM) ....... ** END OF LIST * TABLE 22 INCIDENCE OF MACROSCOPIC OBSERVATIONS 5 WEEK SACRIFICE HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 22.3 -NUMBER-OF-ANIHALS-AFFECTED- SEX: ---MALE GROUP: -i- -2- -3- -4- -5- -6- NUMBER: -IS- 15 - IS IS" 14 --S- IS m NUMBER EXAMINED: IS 15 15 IS 14 IS NOT REMARKABLE: 15 IS IS IS 14 15 NUMBER EXAMINED: IS IS IS IS 14 IS NOT REMARKABLE: IS IS IS 15 14 IS NUMBER EXAMINED: IS 15 IS IS 14 15 NOT REMARKABLE: IS 15 15 15 14 15 6 fc* Qf) coo> m HAZLETON LABORATORIES AMERICA, INC. MADISON, WISCONSIN U S A . TABLE INCLUDES: SEX-ALL;GROUP-ALL WEEKS-ALL DEATH-2;SUBSET-ALL ORGAN AND KEYWORD!S) OR PHRASE * TOP OF LIST * GENERAL COMMENT (GC) ....... ALL TISSUES/ORGANS NORMAL MALOCCLUSION BRAIN (BR| ................ LUNG |LU) ................. MOTTLED LIVER (LI| ................ DIFFUSELY DARK LF. TESTIS (TEO) ......... SMALL PROSTATE (PR| ___ o p 05 00 cn TABLE 23 INCIDENCE OF MACROSCOPIC OBSERVATIONS < WEEK SACRIFICE -- N UM B E R -0 F -A N : SEX; GROUP; -1- -2- -3- -4- -5- -eNUMBER: 15 15 15 15 15 15 NUMBER EXAMINED; 15 15 15 15 15 15 14 13 12 13 14 14 00 1000 NUMBER -EXAMINED: 15 15 IS 15 15 IS NOT REMARKABLE: 15 15 IS 15 15 15 NUMBER EXAMINED: 15 15 15 IS IS 15 NOT REMARKABLE: 14 IS 15 15 15 15 10000 0 NUMBER EXAMINED: 15 15 15 IS 15 15 NOT REMARKABLE: IS 15 15 15 14 IS 0000 10 NUMBER EXAMINED: 15 15 15 15 15 15 NOT REMARKABLE: 15 IS 14 15 15 15 00 10 00 NUMBER EXAMINED: 15 IS 15 15 IS 15 NOT REMARKABLE: 15 IS 15 15 15 15 HWI 6329-100 PRINTED. 15-OCT-91 TABLE.PAGE 2 3 1 I- G0135 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A . TABLE 23 INCIDENCE OF MACROSCOPIC OBSERVATIONS I WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUPALL ;WEEKS-ALL DEATH-2:SUBSET-ALL -- N UM B E R -0 F -A N SEX: --MALE--- GROUP : -1- -2- -3- -4- -5- -e- ORGAN AND KEYWORD(S ) OR PHRASE NUMBER : -m15- -m15- -IS- 15- -a15-- -is- SEMINAL VESICLE (SV) ....................... ......... NUMBER EXAMINED: 15 15 15 15 15 is NOT REMARKABLE: 15 15 15 15 IS 15 COAGULATING OLD (CG| ....................... ......... NUMBER EXAMINED: 15 15 IS 15 15 15 NOT REMARKABLE: 15 15 15 IS 15 15 URETHRA (UR) ............................... ......... NUMBER EXAMINED: 15 15 15 15 15 15 NOT REMARKABLE: 15 15 15 15 15 15 SKIN (SK) ................................... ......... NUMBER EXAMINED: 15 IS 15 15 15 15 NOT REMARKABLE: 15 15 15 15 IS IS KIDNEY(S) |KD) ............................. ......... NUMBER EXAMINED: 15 15 15 15 15 15 NOT REMARKABLE: 15 15 14 15 15 15 LARGE PELVIS(ES) 00 1000 SPLEEN (SP) ........ ........................ ......... NUMBER EXAMINED: 15 15 15 15 IS 15 NOT REMARKABLE: 15 15 15 15 15 15 HWI 6329-100 PRINTED: 1S-0CT-91 TABLE.PAGE: 23.2 CCOo HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A. TABLE INCLUDES: SEX-ALL.GROUP-ALL;WEEKS-ALL DEATH-2;SUBSET-ALL ORGAN AM) KEYWORD!S) OR PHRASE MESENTERIC LN (MS) ......... MOTTLED MANDIB/CERV LN (MN| ........ LARGE LUMBAR/ILIAC LN (LM) ....... ** END OF LIST * TABLE 23 INCIDENCE OF MACROSCOPIC OBSERVATIONS 8 WEEK SACRIFICE HWI 6329-100 PRINTED: 1S-OCT-91 TABLE.PAGE : 23.3 -- N U M B E R - O F - A N I M A L S - A F F E C T E D ---SEX: ............ MALE............ GROUP: -1- -2- -3- -4- -5- -6NUMBER: -1S --15- w15- --1S-- --15-- --15-- NUMBER EXAMINED: IS 15 IS 15 15 15 NOT REMARKABLE: 15 15 15 14 15 15 000 100 NUMBER EXAMINED: 15 15 15 15 IS 15 NOT REMARKABLE: 15 13 IS 14 15 14 020 10 1 NUMBER EXAMINED: 15 15 15 15 15 15 NOT REMARKABLE: IS 15 IS IS IS 15 ASSTGJ 00 to HAZLETON LABORATORIES AMERICA. INC MADISON. WISCONSIN U S A . TABLE 24 INCIDENCE OF MACROSCOPIC OBSERVATIONS 14 WEEK SACRIFICE TABLE INCLUDES SEX-ALL.GROUP-ALL;WEEKS-ALL DEATH-T;SUBSET-ALL ORGAN AND KEYWORD)S) OR PHRASE ** TOP OF LIST ** GENERAL COFWENT (GC| ............ .................... N U M BER - 0 F - A N SEX: ---MALE GROUP : -1- -2- -3- -4- -5- -8- NUMBER: --15- --15- --15-- -15- a15-- -IS NUMBER EXAMINED: 15 15 15 15 15 IS ALL TISSUES/ORGANS NORMAL 14 14 15 13 13 IS BRAIN (BR) ....................... .................... NUMBER EXAMINED: 15 15 15 15 IS 15 NOT REMARKABLE: 15 15 15 15 15 IS LUNG (LU) ........................ .................... NUMBER EXAMINED: 15 IS 15 15 15 IS NOT REMARKABLE: 15 15 15 15 15 15 LIVER (LI) ....................... .................. NUMBER EXAMINED: 15 15 15 15 15 IS NOT REMARKABLE: 15 15 15 15 15 15 LF. TESTIS (TEO) ................. .................... NUMBER EXAMINED: 15 15 IS 15 15 IS NOT REMARKABLE: 15 14 15 IS IS 15 SMALL 0 10000 PROSTATE (PR) ... ......... .................... NUMBER EXAMINED: 15 15 IS 15 15 15 NOT REMARKABLE: 15 15 15 14 15 15 MASS(ES) 0 0 0 10 0 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 24 1 AFFECTEO--- f'SSTOi to o HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE INCLUDES SEX*ALL GROUP-ALL;WEEKS-ALL DEATH*T;SUBSET-ALL ORGAN AND KEYWORD!S) OR PHRASE SEMINAL VESICLE (SV| ....... COAGULATING GLD |CG) ....... URETHRA (UR) ............... SKIN (SK) .................. KIDNEY!S) (KD) ............. LARGE PELVIS(ES) SPLEEN ISP) ....... MESENTERltUN (MS) . TABLE 24 INCIDENCE OF MACROSCOPIC OBSERVATIONS 14 WEEK SACRIFICE ... N U M B E R - 0 F - A N GROUP: -1- -2- -3- -4- -5- -6- NUMBER: 15 15 15 - -*- -- 15 15 15 -- -- - -- NUMBER EXAMINED: 15 15 15 15 15 15 NOT REMARKABLE: 15 15 15 15 15 15 NUMBER EXAMINED: 15 IS IS 15 15 15 NOT REMARKABLE: 15 15 15 15 15 IS NUMBER EXAMINED: 15 IS 15 IS 15 IS NOT REMARKABLE: 15 15 15 15 15 15 NUMBER EXAMINED: 15 15 15 15 15 IS NOT REMARKABLE: 15 15 15 15 15 15 NUMBER EXAMINED: 15 15 15 15 IS IS NOT REMARKABLE: 15 15 15 14 14 15 000 110 NUMBER EXAMINED: 15 15 15 15 15 IS NOT REMARKABLE: 15 15 15 15 15 15 NUMBER EXAMINED: 15 15 15 15 15 15 NOT REMARKABLE: 15 15 15 15 15 15 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 24.2 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A. TABLE INCLUDES. SEX-ALL;GROUP-ALL.WEEKS-ALL DEATH-T:SUBSET-ALL ORGAN AND KEYWORD)S) OR PHRASE MANDIB/CERV LN |MN) ........ LARGE LUMBAR/ILIAC LN |LM) ....... * END OF LIST ** TABLE 24 INCIDENCE OF MACROSCOPIC OBSERVATIONS 14 WEEK SACRIFICE -- N UM B E R -0 F -A N SEX: GROUP: -1- -2- -3- -4- -5- -6NUMBER: IS IS 15 IS IS IS NUMBER EXAMINED: 15 IS 15 IS 15 15 NOT REMARKABLE: 14 15 IS 15 14 15 1000 10 NUMBER EXAMINED: IS 15 IS 15 15 15 NOT REMARKABLE: IS IS 15 15 IS IS HWI 6329-100 PRINTED: 1S-OCT-91 TABLE.PAGE: 24.3 A F F E C T E D --- CC1S57 vroo 0SSTO3 HAZLETON LABORATORIES AMERICA, INC MADISON, WISCONSIN U S A. TABLE INCLUDES: SEXALL;GROUP<ALL;WEEKSALL DEATH*U;SUBSET-ALL ORGAN AND KEYWORD!S) OR PHRASE * TOP OF LIST GENERAL COMMENT JGC) ....... ALL TISSUES/ORGANS NORMAL ANIMAL THIN ANIMAL OBESE BRAIN (BR| .................. LUNG (LU| LIVER |LI 1 IF. TESTIS (TEO) .. PROSTATE (PR) MASS(ES) uO>J TABLE 25 INCIDENCE OF MACROSCOPIC OBSERVATIONS 22 WEEK SACRIFICE -- N UM B E R -0 F SEX: GROUP: -1- -2- -3- -4- -5NUMBER: 10- --10-- -10- -10 -10-- NUMBER EXAMINED: 10 10 10 10 10 10 9 9 0000 1 00 100 NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 NUMBER EXAMINED: 10 10 10 10 to NOT REMARKABLE: 10 10 10 10 10 NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 9 0000 1 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE : 25.1 A F F E C T E D --- bSTOi) HAZLETON LABORATORIES AMERICA. INC MADISON, WISCONSIN U S A . TABLE 25 INCIDENCE OF MACROSCOPIC OBSERVATIONS 22 WEEK SACRIFICE TABLE INCLUDES: SEX'ALL.GROUP'ALL:WEEKS-ALL DEATHU;SUBSET-ALL O-R-G-A-N -A-ND--K-E-Y-W-O-RD-|-S-|--O-R--P-HR-A-SE SEMINAL VESICLE (SV| ........ ........................ -- NUM BER -0 F -AN SEX: ---MALE GROUP: -1- -2- -3- -4- -5- -6- NUMBER: 10- -10- -10 -s10- --*10-- -*0- NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 0 0 COAGULATING OLD (CG) ........................ NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 0 0 URETHRA |UR) ................ ........................ NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 0 0 SKIN (SK| ................... ........................ NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 9 10 10 10 10 ABRASIONISl/ULCERATIONIS) 10 000 KIDNEY)SI (KD) .............. ........................ NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 9 10 LARGE PELVIS(ES) SEMIFLUID MAlERIAL-PELVIS 0 0 0 10 0 0 0 10 SPLEEN (SP| ............... ................... NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 9 10 10 10 10 CYST|S) 1000 0 0 0 0 0 0 0 0 0 0 0 HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 25.2 HAZLETON LABORATORIES AMERICA, INC. MAOISON, WISCONSIN U S A . TABLE INCLUDES: SEX'ALL;GROUP.ALL;WEEKSALL DEATH.U.SUBSET ALL ORGAN AND KEVWOROfS) OR PHRASE MESENTERIC LN (MS) ......... MANDIB/CERV LN (MNJ ........ LARGE LUMBAR/1LIAC LN (LM) ....... LARGE END OF LIST * TABLE 25 INCIDENCE OF MACROSCOPIC OBSERVATIONS 22 WEEK SACRIFICE HWI 6329-100 PRINTED: 15-OCT-91 TABLE.PAGE: 25.3 -- N U M B E R - O F - A N I M A L S - A F F E C T E D ---- SEX: ---MALE GROUP: -1- -2- -3- -4- -5- -6- NUMBER: 10 -10 -10- -10" -a10 0-- NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 0 0 NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 9 0000 1 NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 9 0000 1 0 0 0 0 0 0 098TOQ in HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 26 INCIDENCE OF MICROSCOPIC OBSERVATIONS S WEEK SACRIFICE HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 26 1 TABLE INCLUDES: SEX-ALL;GROUP-ALL;SCREEN-ALL ;WEEKS-ALL DEATH-1;FIND-ALL:SUBSET-ALL ORGAN AND FINDING DESCRIPTION ** TOP OF LIST BRAIN (BR) ..... -- N U M B E R - 0 F - A N II M A L S - A F F E C T E D - - - SEX: GROUP: -1- -2- -3- -4- -5- -6- NUMBER: 15 15- 15 -15- -m14- -15- NUMBER EXAMINED: 15 NOT REMARKABLE: 15 15 15 15 IS 15 15 14 14 15 IS LUNG NUMBER EXAMINED: 15 15 15 14 14 15 NOT REMARKABLE: 15 15 15 14 14 15 LIVER NUMBER EXAMINED: 15 15 15 15 14 15 NOT REMARKABLE: 9 T 2 0 0 10 -INFILTRATES.MONONUCLEAR CELL -INFLAMMATION,GRANULOMATOUS -NECROSIS,COAGULATIVE -FATTY CHANGE -HYPERTROPHY, HEPATOCELLULAR: ACCENTUATED iPPEAR TO HAVE ARE MORE Ro u n d e d g i v i n g the c e l l s a m o r e PLUMP" APPEARANCE EXCEPT FOR THIS 'ENLARGED* APPEARANCE. THE >E 'NORMAL'. -HYPERPLASIA.BILE DUCT 5 T455 4 111 100 000 12 1 00000 1 0 0 12 15 14 0 000000 LF. TESTIS (TEO) NUMBER EXAMINED: 15 15 15 IS 14 15 NOT REMARKABLE: 15 15 15 15 13 IS --ATROPHY/DEGENERATION --INFLAMMATION. GRANULOMATOUS 00 00 10 000000 #58TO0 icon T98T00 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A. TABLE 26 INCIDENCE OF MICROSCOPIC OBSERVATIONS S WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL ;SCREEN-ALL :WEEKS-ALL DEATH-1:FIND-ALL:SUBSET-ALL O--R-G-A-N--A-N-D--F-I-N-D-I-N-G--D-E-S-C-RI"P-T"I-O-N---------PROSTATE (PR) ..... ......................... ......... --INFLAMMATION, CHRONIC ACTIVE SEMINAL VESICLE (SV) ....................... ......... -- HUM B E R -0 F - A N SEX: ---MALE--- GROUP: -1- -2- -3- -4- -5- -6- NUMBER: -15- IS- 15m --15-- 14 m - 15 NUMBER EXAMINED: 15 15 14 15 14 15 NOT REMARKABLE: 15 15 14 15 14 13 000002 NUMBER EXAMINED: IS 15 14 15 14 IS NOT REMARKABLE: 15 IS 14 15 14 15 COAGULATING OLD (CG) ....................... ......... NUMBER EXAMINED: 15 15 14 15 14 15 NOT REMARKABLE: 15 IS 14 IS 14 IS URETHRA (UR) ............................... ......... NUMBER EXAMINED: 15 IS 14 15 14 14 NOT REMARKABLE: 15 15 14 IS 14 14 KIDNEY(S) |KD) ............................. ......... NUMBER EXAMINED: 1 2 0 2 3 1 NOT REMARKABLE: 0 0 0 0 0 0 --DILATATION,PELVIC 12023 1 SKIN (SK) .................. ........ ......... NUMBER EXAMINED: 0 0 1 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --DERMATITIS --ULCERATION 0 0 10 0 0 000000 HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE : 26.2 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 26 INCIDENCE OF MICROSCOPIC OBSERVATIONS S WEEK SACRIFICE TABLE INCLUDES: SEX*ALL.GROUPALL:SCREEN-ALL;WEEKS-ALL DEATH-i,FIND-ALL.SUBSET.ALL N U M B E R -0 F -a n : SEX: ---MALE GROUP: -1- -2- -3- -4- -5- -6- ORGAN AND FINDING DESCRIPTION NUMBER: -m15- 15 -1m5- -015- 14-- --15-- SPLEEN |SP) ....... ......................... 000 100 NOT REMARKABLE: 0 0 0 l 0 0 --CVST. SEROSAL 000000 MANDIB/CERV LN (MN| .......................... ....... NUMBER EXAMINED: 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --HYPERPLASIA. LYMPHORETICULAR CELL 000000 MESENTERIC LN |MS) ........................... ....... NUMBER EXAMINED: 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 LUMBAR/ILIAC LN |LM) ......... ................ ....... NUMBER EXAMINED: 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --HYPERPLASIA. LYMPHORETICULAR CELL ** END OF LIST 000000 HWI 6329-100 PRINTED: 1S-0CT-91 TABLE.PAGE: 26.3 98X00 0o0 ^98TO0 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A. TABLE 27 INCIDENCE OF MICROSCOPIC OBSERVATIONS t WEEK SACRIFICE TABLE INCLINES: SEX-ALL :GROUP-ALL :SCREEN-ALL ;WEEKS-ALL DEATH-2;FIND-ALL;SUBSET-ALL ORGAN AND FINDING DESCRIPTION ** TOP OF LIST ** BRAIN (BR) ........ ........... --- N U M B E R - 0 F - A N : SEX: --MALE--- GROUP: -1- -2- -3- -4- -5- -6- NUMBER: 1S IS 15 15 15 15 NUMBER EXAMINED. IS IS 15 IS 15 15 NOT REMARKABLE: IS IS IS IS 15 IS LUNG (LU) ....................... NUMBER EXAMINED: 14 15 13 14 15 15 NOT REMARKABLE: 14 15 13 14 15 15 LIVER (LI 1 ...................... NUMBER EXAMINED: 15 IS 15 15 15 15 NOT REMARKABLE: 11 12 3 0 0 10 --INFILTRATES.MONONUCLEAR CELL --INFLAMMATION.GRANULOMATOUS --NECROSIS,COAGULATIVE --FATTY CHANGE --HYPERTROPHY. HEPATOCELLULAR: CHARACTERIZED BY AN ACCENTUATED CENTRILOBULATED PATTERN IN WHICH THE HEPATOCYTES APPEAR TO HAVE A MORE HOMOGENEOUS CYTOPLASM AND THE CELL BORDERS ARE MORE ROUNDED GIVING THE CELLS A MORE 'PLUMP" APPEARANCE EXCEPT FOR THIS 'ENLARGED* APPEARANCE. THE CELLS; ARE OTHERWISE 'NORMAL'. --HYPERPLASIA.BILE DUCT 43I455 000 100 0000 10 000000 0 0 12 15 IS 0 000 00 0 LF. TESTIS |TEO) ................ NUMBER EXAMINED: IS 15 15 15 15 15 NOT REMARKABLE: 15 15 14 15 15 IS --ATROPHY/DEGENERATION --INFLAMMATION. GRANULOMATOUS 00 10 00 000000 IOo HWI 6329-100 PRINTEO: 1S-0CT-91 TABLE.PAGE : 27.1 ^98T00 1I11111111111111111111111111111111111t11 HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 27 INCIDENCE OF MICROSCOPIC OBSERVATIONS I WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL:SCREEN-ALL :WEEKS-ALL DEATH-2;FIND-ALL;SUBSET.ALL -- HUM 8 E R -0 F - A N SEX: --MALE--- GROUP: -1- -2- -3- -4- -5- - a - ORGAN ANO FINDING DESCRIPTION NUMBER: IS 15 --IS- -'15-- m15-- IS PROSTATE (PR I ........................... ............. NUMBER EXAHINEO: IS 15 IS 15 15 15 NOT REMARKABLE: 14 15 15 IS 14 15 --INFLAMMATION. CHRONIC ACTIVE 1000 10 SEMINAL VESICLE (SV| .................... ............. NUMBER EXAMINED: 15 15 15 15 15 IS NOT REMARKABLE: 15 15 15 IS 15 15 COAGULATING GLD (CG) .................... ............ NUMBER EXAMINED: IS IS 15 15 IS 15 NOT REMARKABLE: IS 15 15 15 15 15 URETHRA (UR) ............................ ............ NUMBER EXAMINED: 15 IS 15 14 14 14 NOT REMARKABLE: IS 15 15 14 14 14 KIDNEYISI (KD) .......................... ............. NUMBER EXAMINED: 0 0 1 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --DILATATION.PELVIC 00 100 0 SkIN (SK| ............... ....... ............. NUMBER EXAMINED: 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --DERMATITIS --ULCERATION 000000 000000 oo HWI 6329-100 PRINTED: 1S-OCT-91 TABLE.PAGE: 27.2 C018S HAZLETON LABORATORIES AMERICA. INC MADISON, WISCONSIN U S A . TABLE 27 INCIDENCE OF MICROSCOPIC OBSERVATIONS I WEEK SACRIFICE TABLE INCLUDES SEX-ALL:GROUP-ALL:SCREEN-ALLWEEKS-ALL DEATH-2 :FIND-ALL:SUBSET-ALL ORGAN AND FINDING DESCRIPTION -----------------------SPLEEN (SP) ....... ........................ ........ --CVST. SEROSAL MANDIB/CERV LN |MN) ......................... ........ --HYPERPLASIA. LYMPHORETICULAR CELL MESENTERIC LN IMS) .......................... ........ ... N U M B E R - 0 F - A N SEX: --MALE GROUP : -1- -2- -3- -4- -5- -6- NUMBER: -15. -a15<" .a15. .a15 --a15-- -aIS. NUMBER EXAMINED: 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 000000 NUMBER EXAMINED: 0 2 0 1 0 1 NOT REMARKABLE: 0 0 0 0 0 0 020 10 1 NUMBER EXAMINED: 0 0 0 1 0 0 NOT REMARKABLE: 0 0 0 1 0 0 LUMBAR/ILIAC LN (LM) ........................ ........ NUMBER EXAMINED: 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --HYPERPLASIA. LYMPHORETICULAR CELL * END OF LIST * 000000 HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 27.3 AFFECTED--- HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 2* INCIDENCE OF MICROSCOPIC OBSERVATIONS 14 W E E K SACRIFICE HWI 6329-100 PRINTED: 1S-0CT-91 T A B L E .P A G E : 2 1 . 1 TABLE INCLUDES: S E X - A L L ; G R O U P - A L L ;S C R E E N - A L L W E E K S - A L L DEATH-T;FIND-ALLSUBSET-ALL OROAN AND FINDING DESCRIPTION * T O P O F L I S T * B R A I N |BR) ...... IUNO LIVER -INFILTRATES.MONONUCLEAR CELL - I N F L A M M A T I O N ,G R A N U L O M A T O U S -NECROSIS.COAGULATIVE -FATTY CHANGE -HYPERTROPHY, HEPATOCELLULAR: ROUNDED GIVING THE CELLS A MORE 'PLUMP' THIS "ENLARGED* APPEARANCE. THE CFILS 4 -HYPERPLASIA.BILE DUCT Lf* TESTIS (TEO) --ATROPHV/DEGENERATION --INFLAMMATION. GRANULOMATOUS ... N U M B E R - 0 F - A N I M A L S SEX: *rWLt G R O U P : -1- -2- -3- -4- -5- -6- N U M B E R : --15-- m15m --1a5-- -15" IaS- -a15 N U M B E R E X A M I N E D : 15 is 15 IS 15 15 N O T R E M A R K A B L E : IS 15 IS 15 15 15 AFFECTED--- N U M B E R E X A M I N E D : 15 15 15 15 15 15 N O T R E M A R K A B L E : IS IS 15 15 IS 15 N U M B E R E X A M I N E O : 15 IS 15 15 IS 15 N O T R E M A R K A B L E : 12 11 2 1 0 7 ACCENTUATED iPPEAR TO HAVE ARE MORE . EXCEPT FOR >E ' N O R M A L * . 33e5 71 0013 0 0 0 10 100 0 00000 0 0 13 14 IS 0 000000 N U M B E R E X A M I N E D : 15 15 15 15 15 15 N O T R E M A R K A B L E : 15 14 IS IS 15 15 0 10000 0 10000 o S8T00 111< 1111 11tt11111 1 111 1111 11 111 1 11 1 1 1 t1 1 11 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U S A . TABLE 21 INCIDENCE OF MICROSCOPIC OBSERVATIONS 14 WEEK SACRIFICE HWI 6329-100 PRINTED: 14-0CT-91 TABLE.PAGE: 21.2 TABLE INCLUDES: SEX-ALL:GROUP-ALL:SCREEN-ALL :WEEKS-ALL DEATH-T:FIND-ALL:SUBSET-ALL ... N U M B E R - 0 F - A N I M A L S SEX: ---MALE---- GROUP : -1- -2- -3- -4- -5- -6- ORGAN AND FINOING DESCRIPTION NUMBER: IS -- 15 -- 15 ---- - aIS- --a15- IS *a- PROSTATE (PR) ..... ....................... ............ NUMBER EXAMINED: 15 IS IS is 15 15 NOT REMARKABLE: IS 15 13 14 14 14 --INFLAMMATION. CHRONIC ACTIVE 002111 SEMINAL VESICLE (SV| ............................ ............ NUMBER EXAMINED: IS IS IS IS IS IS NOT REMARKABLE: 15 IS IS IS 15 15 COAGULATING GLD fCQ) ....................... ......... NUMBER EXAMINED: 15 IS 15 15 IS IS NOT REMARKABLE: IS IS IS 15 IS IS URETHRA (UR) ................................ ......... NUMBER EXAMINED: IS IS 15 IS IS IS NOT REMARKABLE: IS 15 IS IS IS IS KIDNEY IS) (KD) ............................. ............ NUMBER EXAMINED: 0 0 0 1 1 0 NOT REMARKABLE: 0 0 0 0 0 0 --DILATATION.PELVIC 00 0 1 10 SKIN (SK) ....................... ....... ............ NUMBER EXAMINED: 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 -DERMATITIS --ULCERATION 00 0 0 0 0 000000 ogo HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 21 INCIDENCE OF MICROSCOPIC OBSERVATIONS 14 WEEK SACRIFICE HWI 6329-100 PRINTED: 1S-0CT-91 TABLE.PAGE: 21.3 TABLE INCLUDES: S E X - A L L ;G R O U P - A L L :S C R E E N - A L L . W E E K S - A L L d e a t h - 1 , f i n d -a l l .Su b s e t -a l l N U M B E R - 0 F - aA N I: M A L S - A F F E C T E D SEX: --MALE G R OU P: -1- -2- -3- -4 - -5- -6 - ORGAN AND FINDING DESCRIPTION N U M B E R : 15 15 -- 15 IS 15 15 " -- S P L E E N |SP> ....... ............................. ...... N U M B E R E X A M I N E D : 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --CYST. SEROSAL 000000 M A N D I B / C E R V L N (MN) ................................... ...... N U M B E R E X A M I N E D : 1 0 0 0 1 0 NOT REMARKABLE: 0 0 0 0 0 0 --HYPERPLASIA, LYMPHORETICULAR CELL 100 0 10 M E S E N T E R I C LN (MS) .................................... ...... N U M B E R E X A M I N E O : 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 -- L U M B A R / I L I A C L N (LM) ................................. ...... N U M B E R E X A M I N E D : 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --HYPERPLASIA. LYMPHORETICULAR CELL ** END OF LIST ** 000000 C-018: o 0Z.STOO HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 20 INCIDENCE OF MICROSCOPIC OBSERVATIONS 22 WEEK SACRIFICE TABLE INCLUDES: SEX-ALL.GROUPALL ;SCREEN-ALL ;WEEKS-ALL DEATH-U;FIND-ALL;$UBSETALL ORGAN AND FINDING DESCRIPTION * TOP OF LIST BRAIN |BR| ... ... N U M B E R - 0 F - a n : SEX: GROUP: -I- -2- -3- -4- -5- -6- NUMBER: 10 - 10 -- - a10- O -- a10-- - a0- NUMBER EXAMINED: 10 10 NOT REMARKABLE: 10 10 9 10 10 9 10 10 0 0 LUNG NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 0 0 LIVER NUMBER EXAMINED: 10 NOT REMARKABLE: s 10 5 10 6 10 1 107 -INFILTRATES.MONONUCLEAR CELL -INF LAMMATION.GRANULOMATOUS -NECROSIS.COAGULATIVE -FATTY CHANGE -HYPERTROPHY, HEPATOCELLULAR: CHARAC ACCENTUATED CENTRILOBULATED PATTERN IN WHICH THE HEPATOCYTES APPEAR TO HAVE A MORE HOMOGENEOUS CYTOPLASM AND THE CELL BORDERS ARE MORE ROUNDED GIVING THE CELLS A MORE "PLUMP' APPEARANCE. EXCEPT FOR THIS "ENLARGED* APPEARANCE, THE CELLS ARE OTHERWISE "NORMAL" . --HYPERPLASIA,BILE DUCT 242 1 3 20 0 0 0 1 1 1 10 0 0 10 0 00000 0 10 00 TESTIS (TEO) .................. .......... NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 9 9 9 10 --ATROPHY/DEGENERATION --INFLAMMATION. GRANULOMATOUS 0 11 10 00000 0 0 0 0 0 0 0 0 0 0 0 0 cn HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 29 1 A F F E C T E D --- HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 29 INCIDENCE OF MICROSCOPIC OBSERVATIONS 22 WEEK SACRIFICE HWI 6329-100 PRINTED. 1S-OCT-91 TABLE.PAGE: 29.2 TABLE INCLUDES: SEX*AlL :GROUPALL :SCREENALL :WEEKSALL DEATH*U:FINDALL ;SUBSET*ALL --- N U M B E R - 0 F - A N I M A L S SEX: ---MALE--- GROUP: -1- ORGAN AND FINDING DESCRIPTION NUMBER: 10 10 -10 -10-- --a10-- --a0 PROSTATE (PR) ..... ........................ ........ NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: - 10 10 10 --INFLAMMATION. CHRONIC ACTIVE 20002 SEMINAL VESICLE (SV| ........................ ........ NUMBER'EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 0 0 0 0 0 COAGULATING GLD (CG) ........................ ........ NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 0 0 URETHRA (UR) ................................ ........ NUMBER EXAMINED: 10 10 10 10 10 NOT REMARKABLE: 10 10 10 10 10 0 0 KIDNEY(S) |KD) .............................. ........ NUMBER EXAMINED: 0 0 0 1 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --DILATATION,PELVIC 0 00 10 0 SKIN |SK) .............. .............. ........ NUMBER EXAMINED: 1 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 --DERMATITIS --ULCERATION 10 0 0 0 0 10 0 00 0 P-.STOO 001 HAZLETON LABORATORIES AMERICA. INC MADISON, WISCONSIN U S A . TABLE INCLUDES. SEX-ALL;GROUP-ALL:SCREEN-ALL;WEEKS>ALL DEATH-U,FIND-ALL;SUBSET-ALL ORGAN AND FINDING DESCRIPTION SPLEEN (SP| ....... ..................... --CYST, SEROSAL MANDIB/CERV LN (MNJ .................... --HYPERPLASIA. LYMPHORETICULAR CELL MESENTERIC LN (MS) ..................... LUMBAR/ILIAC LN (LM) ................... --HYPERPLASIA. LYMPHORETICULAR CELL END OF LIST ** TABLE 29 INCIDENCE OF MICROSCOPIC OBSERVATIONS 22 WEEK SACRIFICE --- N U M B E R - 0 F - A N SEX: GROUP: -INUMBER: 10 10 10 10 10 0 NUMBER EXAMINED: 1 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 100 0 0 0 NUMBER EXAMINED: 0 0 0 0 1 0 NOT REMARKABLE: 0 0 0 0 0 0 0000 10 NUMBER EXAMINED: 0 0 0 0 0 0 NOT REMARKABLE: 0 0 0 0 0 0 NUMBER EXAMINED: 0 0 0 0 1 0 NOT REMARKABLE: 0 0 0 0 0 0 0000 10 HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 29.3 A F F E C T E D --- ^STOO oj C01S7J HAZLETON LABORATORIES AMERICA. INC. MAOISON. WISCONSIN U S A . TABLE 30 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS 5 ' WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL;SCREEN-ALL;WEEKS-ALL DEATH-1;FIN0*ALL;SUBSET-ALL ORGAN/TISSUE EXAMINED * TOP OF LIST ** BRAIN (BR) ........ ...................... .......... LUNG |LU) ....... ........................ .......... LIVER (LI) ................................ .......... --INFILTRATES,MONONUCLEAR CELL --INF LA MM AT IO N.GRANULOMATOUS --NECROSIS,COAGULAIIVE . --FATTY CHANGE ** CONTINUED ON NEXT PAGE ""- N U M B E R - 0 F - A N SEX: GROUP: -1- -2- -3- -4- -s- -6NUMBER: IS 15 15 15 14 15 NUMBER EXAMINED: 15 15 IS IS 14 IS NUMBER EXAMINED: IS 15 15 14 14 15 NUMBER EXAMINED-:> IS 10 15 1 IS 11 15 10 14 9 15 11 1> 3 S 4 5 4 3 2> 2 2 0 0 1 1 TL> 15 15 15 IS 14 15 -> 14 14 14 14 14 15 1> 0 1 1 0 0 0 2> 0 0 0 1 0 0 3> 1 0 0 0 0 0 TL> 15 IS 15 IS 14 15 -> IS 15 15 14 12 14 2> 0 0 0 0 1 1 3> 0 TL> 15 0 15 0 IS 11 IS 14 0 15 -> 15 15 15 IS 14 14 2> 0 0 0 0 0 1 TL> 15 15 15 15 14 IS o00 HWI 6329-100 PRINTED: 16-OCT-91 TABLE.PAGE: 30.1 ^8T09 HAZLETON LABORATORIES AMERICA. INC. MADISON, WISCONSIN U.S A. TABLE 30 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS S WEEK SACRIFICE TABLE INCLUDES: SEXALL;GROUP*ALLSCREEN*ALL;WEEKSALL DEATH*1;FIND*ALL;SUBSET-ALL ... N U M B E R - 0 F - A N SEX: --MALE--- GROUP: -1- -2- -3- -4- -5- -6- OROAN/TISSUE EXAMINED NUMBER: 15 IS 15 IS 14 15 FROM PREVIOUS PAGE LIVER ILI) ......... .................................. NUMBER EXAMINED: 15 15 15 IS 14 15 --HYPERTROPHY. HEPATOCELLULAR: CHARACTERIZED BY AN ACCENTUATED -> 15 15 3 0 0 15 CENTRILOBULATED PATTERN IN WHICH THE HEPATOCYTES APPEAR TO HAVE 1> 0 0 12 7 S 0 A MORE HOMOGENEOUS CYTOPLASM AND THE CELL BORDERS ARE MORE 2> 0 0 0 I 9 0 ROUNDED GIVING THE CELLS A MORE `PLUMP' APPEARANCE. EXCEPT FO TL> 15 15 IS IS 14 15 THIS `ENLARGED' APPEARANCE. THE CELLS ARE OTHERWISE `NORMAL*. --HYPERPLASIA,BILE DUCT -> 15 15 15 15 14 15 TL> 15 15 15 15 14 15 LF. TESTIS (TEO) ...................................... NUMBER EXAMINED: 15 15 15 15 14 15 --ATROPHY/DEGENERATION > 15 15 15 IS 13 15 3> 0 0 0 0 1 0 TL> 15 15 15 15 14 IS --INFLAMMATION. GRANULOMATOUS -> 15 15 15 15 14 15 TL> 15 IS 15 15 14 15 PROSTATE fPR 1 ..................... .................. NUMBER EXAMINED: 15 15 14 15 14 IS --INFLAMMATION. CHRONIC ACTIVE -> 15 IS 14 15 14 13 2> 0 3> 0 0 0 0 0 0 0 0 0 1 1 TL> 15 IS 14 15 14 15 SEMINAL VESICLE |SV) ..... .................... NUMBER EXAMINED: 15 15 14 15 14 15 o<o HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE. 30.2 AFFECTEO--- HAZLETON LABORATORIES AMERICA, INC. MADISON, WISCONSIN U S A . TABLE 30 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS 5 WEEK SACRIFICE HWI 6329-100 PRINTED: lt-OCT-91 TABLE.PAGE: 30.3 TABLE INCLUDES: SEX-ALL;GROUP-ALL:SCREEN-ALL;WEEKS-ALL DEATH*1;FIND-ALL;SUBSET*ALL ORQAN/TISSUE EXAMINED ... N U M B E R - 0 F - A K I M A L S - A F f SEX: .... ---MALE GROUP: -1- -2- -3- -4- -5- -a- NUMBER: 15 15 15 15 14 15 ECTEO- COAQULATINO OLD (COI ................... ............. NUMBER EXAMINED: IS IS 14 IS 14 is URETHRA (UR) ........................... ............. NUMBER EXAMINED: IS IS 14 15 14 14 KIDNEY)S) (KD) ......................... ............. NUMBER EXAMINED: 1 2 0 2 3 1 --DILATATION.PELVIC P> 1 2 0 2 3 1 TL> 1 2 0 2 3 1 SKIN (SK) .............................. ............. NUMBER EXAMINED: 0 0 1 0 0 0 --DERMATITIS 3> 0 0 1 0 0 0 TL> 0 0 1 0 0 0 --ULCERATION -> 0 0 1 0 0 0 TL> 0 0 1 0 0 0 SPLEEN (SP| ............................ ............ NUMBER EXAMINED: 0 0 0 1 0 0 --CYST, SEROSAL -> 0 TL> 0 0 0 0 0 1 1 0 0 0 0 MANDIB/CERV LN (MN) !................... --HYPERPLASIA, LYMPHORETICULAR CELL ...... NUMBER EXAMINED: 0 TL> 0 0 0 0 0 0 0 0 0 0 0 MESENTERIC LN (MS) ..................... ...... NUMBER EXAMINED: 0 0 0 0 0 0 LUMBAR/ILIAC LN (LM) ................... --HYPERPLASIA. LYMPHORETICULAR CELL ** END OF LIST ** ..... NUMBER EXAMINED: 0 0 0 0 0 0 TL> 0 0 0 0 0 0 &U8T00 o ^STGD HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN US .A . TABLE 31 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS WEEK SACRIFICE TABLE INCLUOES: SX-ALl;CROUP-ALL:SCREEN*ALL;WEEKS*ALL DEATH-2;FIND*ALL:SUBSET-ALL ORGAN/TISSUE EXAMINED FROM PREVIOUS PAGE * LIVER (LI I ............... --HYPERPLASIA.BILE DUCT IF. TESTIS (TEO) ....... --A TROPHY/DEGENERATION --INFLAMMATION. GRANULOMATOUS PROSTATE (PR) ___ --INFLAMMATION. CHRONIC ACTIVE SEMINAL VESICLE (SV) ___ COAGULATING GLD (CO) ___ URETHRA (UR) ........... -- N UM B E R -0 F -A N SEX: GROUP: -1- -2- -3- -4- -5- -6- NUMBER: 15- -a15- 15 -aIS-- -m15- -aIS~ NIMBER EXAMINED: IS -> 15 15 15 IS 15 is 15 15 15 15 15 TL> 15 IS 15 15 15 15 NUMBER EXAMINED-:> 15 IS 15 15 15 14 15 15 15 15 IS IS 4> 0 0 1 0 0 0 TL> 15 15 15 15 15 15 -> 15 IS 15 IS 15 15 TL> 15 15 15 15 15 15 NIMBER EXAMINED: 15 -> 14 IS 15 15 15 15 15 15 14 15 IS 2> 1 0 0 0 0 0 3> 0 0 0 0 1 0 TL> IS IS 15 15 15 IS NUMBER EXAMINED: 15 15 15 15 IS 15 NUMBER EXAMINED: 15 15 15 15 15 IS NUMBER EXAMINED: 15 IS 15 14 14 14 HWI 6329-100 PRINTED. ll-OCT-91 TABLE.PAGE: 31.2 AFFECTED--- HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 31 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS I WEEK SACRIFICE HWI 6329-100 PRINTED: 18-OCT-91 TABLE PAGE: 31.1 TABLE INCLUDES: SXALL;GROUPALL:SCREEN*ALLWEEKS"ALL DEATH-2 FIND-ALL;SUBSET-ALL ---NUMBER-OF-AN IM A L S SEX: ---MALE--- GROUP: -1- -2- -3- - -5- -6- ORGAN/TISSUE EXAMINED ** TOP OF LIST BRAIN (BR| ............................. NUMBER: --*15- _B15- --15-- --15 --a15- a15 NUMBER EXAMINED. 15 15 15 15 15 15 LUNG (LU) .............................. NUMBER EXAMINED: 14 15 13 14 15 IS LIVER |LI) ............................. --INFILTRATES.MONONUCLEAR CELL NUMBER EXAMINED: -> 15 11 15 12 15 14 15 11 15 10 15 10 1> 4 3 0 4 3 3 2> 0 0 1 0 2 2 TL> 15 15 15 IS 15 IS --INF LAMMATION.GRANULOMA TOUS > 15 IS 15 14 15 IS 1> 0 0 0 1 0 0 TL> IS 15 15 15 15 IS --NECROSIS.COAGULATIVE "> 15 15 15 15 14 15 2> 0 0 0 0 1 0 TL> 15 15 15 IS 15 IS --FATTY CHANGE -> 15 15 15 15 15 15 TL> 15 IS 15 15 IS 15 --HYPERTROPHY. HEPATOCELLULAR: CHARACTERIZED BY AN ACCENTUATED -> 15 15 3 0 0 IS CENTRUOBUlAt e D PATTERN IN WHICH THE HEPATOCVTES APPEAR TO HAVE 1> 0 0 12 14 6 0 A MORE HOMOGENEOUS CYTOPLASM AND THE CELL BORDERS ARE MORE 2> 0 0 0 1 9 0 ROUNDED GIVING THE CELLS A MORE 'PLUMP" APPEARANCE. EXCEPT FO TL> 15 15 15 IS IS IS THIS 'ENLARGED' APPEARANCE, THE CELLS ARE OTHERWISE 'NORMAL' . ** CONTINUED ON NEXT PAGE ** A F F E C T E D --- C01S7 po HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 31 INCIDENCE OE SEVERITY OF MICROSCOPIC OBSERVATIONS I WEEK SACRIFICE TABLE INCLUDES. SEX-ALL;GROUP-ALL,SCREEN-ALL;WEEKS-ALL DEATH-2;FIND-ALL;SUBSET-ALL ORGAN/TISSUE EXAMINED KIDNEY!SI (KDJ .... --DILATATION.PELVIC SKIN (SKI ..... --DERMATITIS --ULCERATION SPLEEN ISP) ........................... --CYST. SEROSAL MANDIB/CERV LN IMN| ................... --HYPERPLASIA, LYMPHORETICULAR CELL MESENTERIC LN (MS| .................... LUMBAR/ILIAC LN fLM| .................. --HYPERPLASIA. LYMPHORETICULAR CELL * END OF LIST -- NUM BER -0 F -A N SEX: GROUP: -1- -2- -3- -4- -5- -6NUMBER: m15 15 -15- -15-- m15 IS NUM8ER EXAMINED: 0 0 1 0 0 0 P> 0 0 1 0 0 0 TL> 0 0 1 0 0 0 NUMBER EXAMINED: 0 0 0 0 0 0 TL> 0 0 0 0 0 0 TL> 0 0 0 0 0 0 NUMBER EXAMINED: 0 0 0 0 0 0 TL> 0 0 0 0 0 0 NUMBER EXAMINED: 0 2 0 1 0 1 3> 0 2 0 1 0 1 TL> 0 2 0 1 0 1 NUMBER EXAMINED: 0 0 0 1 0 0 NUMBER EXAMINED: 0 0 0 0 0 0 TL> 0 0 0 0 0 0 HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 31.3 O o 00 <1 fstOO HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 32 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS 14 WEEK SACRIFICE TABLE INCLUDES: SEX*ALL;GROUPALL;SCREEN*ALL:WEEKS*ALL DEATH-T,FIND-ALL,SUBSET-ALL ORGAN/TISSUE EXAMINED TOP OF LIST * BRAIN (BR) ..................................... ..... LUNG (LU) ....................................... ..... LIVER (LI) ...................................... ..... --INFILTRATES.MONONUCLEAR CELL --INFLAMMATION.GRANULOMATOUS --NECROSIS,COAGULATIVE --FATTY CHANGE * CONTINUED ON NEXT PAGE ** __ N U M B E R - 0 F - A N SEX: --MALE--- GROUP.- -1- -2- -3- -4- -5- -6- NUMBER: 15 15 IS 15 15 15 NUMBER EXAMINED: 15 15 15 IS 15 15 NUMBER EXAMINED: 15 15 IS IS 15 15 NUMBER EXAMINED":> 15 12 15 12 15 9 15 10 159 15 7 1> 2 3 5 4 7 6 2> 1 0 1 1 0 2 TL> 15 15 15 15 15 15 - > IS 15 14 12 15 15 1> 0 0 1 2 0 0 2> 0 0 0 1 0 0 TL> 15 15 15 15 15 15 - > 15 14 15 14 15 15 2> 0 1 0 1 0 0 TL> 15 15 IS 15 IS 15 -> 15 15 15 15 15 15 TL> 15 IS 15 15 15 IS HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 32.1 HA2LET0N LABORATORIES AMERICA, INC. MADISON, WISCONSIN U S A . TABLE 32 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS 14 WEEK SACRIFICE HWI 6329-100 PRINTED: ll-OCT-91 TABLE.PAGE: 32.2 TABLE INCLUDES: SEXALL;QROUP*ALL.SCREEN-ALL ,WEKSALL DEATH-T;F IND-ALL;SUBSETALL OROAN/TISSUE EXAMINED * FROM PREVIOUS PAGE LIVER (LII .... --HYPERTROPHY HEPATOCELLULAR : ROUNDED GIVING THE CELLS A MORE `PLUMP* THIS 'ENLARGED* APPEARANCE. THE CELLS A( --HYPERPLASIA,BILE DUCT LF. TESTIS (TE01 ........ --ATROPHY/DEGEHERATION --INFLAMMATION, GRANULOMATOUS PROSTATE (PR) ...... ............. --INFLAMMATION, CHRONIC ACTIVE SEMINAL VESICLE (SV| O O P GO GO* -- NUMBER-OF-ANIMALS-AFFECTED SEX: ---MA LE--- GROUP: -1- -2- -3- -4- -5- -6- NUMBER: -IS-- -IS- -IS 15- mIS- --aIS-- NUMBER EXAMINED: 15 15 15 IS 15 IS ACCENTUATED -> IS 15 2 1 0 15 APPEAR TO HAVE 1> 0 0 13 12 3 0 ARE MORE 2> 0 0 0 2 12 0 E. EXCEPT FO TL> IS SE "NORMAL". 15 IS 15 15 IS -> IS 15 IS 15 15 15 TL> IS 15 15 15 15 15 NUMBER EXAMINED-:> IS IS 15 14 15 15 15 15 IS IS 15 IS 3> 0 1 0 0 0 0 TL> 15 15 15 15 15 15 -> IS 14 15 15 15 15 3> 0 1 0 0 0 0 TL> 15 15 15 15 15 15 NUMBER EXAMINED: -> IS 15 15 IS 15 13 15 14 IS 14 IS 14 2> 0 0 2 0 0 1 3> 0 0 0 1 1 0 TL> IS 15 15 15 15 15 NUMBER EXAMINED: 15 15 15 15 IS 15 --- HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U.S.A. TABLE 32 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS 14 WEEK SACRIFICE HWI 6329-100 PRINTED: It OCT-91 TABLE.PAGE: 32.3 TABLE INCLUDES: SEX-ALL;GROUP-ALLSCREEN-ALL;WEEKS-ALL DEATH-T,FIND-ALL;SUBSET-ALL ORGAN/TISSUE EXAMINED COAGULATING OLD (CG| .. URETHRA (UR) ......... KIDNEY]S) IKD) ....... --DILATATION.PELVIC SKIN --DERMATITIS --ULCERATION SPLEEN ISP) ...... --CYST, SEROSAL MANDIB/CERV LN (MN) ................... --HYPERPLASIA. LYMPHORETICULAR CELL MESENTERIC LN (MS) LUMBAR/ILIAC LN (LM) .................. --HYPERPLASIA, LYMPHORETICULAR CELL END OF LIST ** __ N U M B E R - 0 F - A N I M A L S - A F F E C T SEX: GROUP: -1- -2- -3- -4- -5- -8NUMBER: -15- -1a5m --15-- -1m5-- IS -mIS- ... NUMBER EXAMINED: 15 15 15 15 15 is ... NUMBER EXAMINED: 15 is 15 IS IS 15 ... NUMBER EXAMINED: 0 0 0 1 1 0 P> 0 0 0 1 1 0 TL> 0 0 0 1 1 0 ... NUMBER EXAMINED: 0 0 0 0 0 0 TL> 0 0 0 0 0 0 TL> 0 0 0 0 0 0 ... NUMBER EXAMINED: 0 0 0 0 0 0 TL> 0 0 0 0 0 0 ... NUMBER EXAMINED: 1 0 0 0 1 0 3> 1 0 0 0 1 0 TL> 1 0 0 0 1 0 ... NUMBER EXAMINED: 0 0 0 0 0 0 ... NUMBER EXAMINED: 0 0 0 0 0 0 TL> 0 0 0 0 0 0 E D --- fsSTOO O HAZLETON LABORATORIES AMERICA, INC. MADISON, WISCONSIN U S A. TABLE 33 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS 22 WEEK SACRIFICE HWI 6329-100 PRINTED: 18-OCT-91 TABLE.PAGE : 33.1 TABLE INCLUDES: SEXALL;GROUP*ALLSCREEN*ALL ;WEEKSALL DEATH.U;FIND-ALL ;SUBSET-ALL ORQAN/TISSUE EXAMINED * TOP OF LIST BRAIN (BRI ....... ........................ ......... LUNG (LU| ...... .......................... ......... LIVER ( H I ................................. ......... --INFILTRATES,MONONUCLEAR CELL --INFLAMMATION.GRANULOMATOUS --NECROSIS.COAGULATIVE --FATTY CHANGE , CONTINUED ON NEXT PAGE * -- N UM B E R -0 F -A N IM A LS SEX: --MALE--- GROUP : -1- -2- -3- -4- -5- -6- NUMBER: 10 10 10 10 10 0 NUMBER EXAMINED: 10 10 9 10 10 NUMBER EXAMINED: 10 10 10 10 10 NUMBER EXAMINED: 10 10 10 10 10 -> 1 6 1 9 7 1> 1 3 1 1 1 2> 1 1 1 0 2 TL> 10 10 10 10 10 -> 1 10 10 10 10 1> 1 0 0 0 0 2> 1 0 0 0 0 TL> 10 10 10 10 10 -> 9 9 9 9 10 2> 1 1 1 1 0 TL> 10 10 10 10 10 -> 10 10 9 10 10 3> 0 0 1 0 0 TL> 10 10 10 10 10 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 A F F E C T E D --- jf&STOO HAZLETON LABORATORIES AMERICA. INC. MADISON. WISCONSIN U S A . TABLE 33 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS 22 WEEK SACRIFICE TABLE INCLUDES: SEX'ALL:GROUPALL:SCREENALL;WEEKS"ALL DEATH>U.FINDALL:SUBSET-ALL -- N UM B E R -0 F -A N SEX: --MALE--- GROUP: -1- -2- -3- -4- -5- -6- ORQAN/TISSUE EXAMINED -------------------------- ------- -------- ---------- ----N--U--MBER: --10-- -10- 10 ~10-- 10- -0" ** FROM PREVIOUS PAGE LIVER (LI) ........ .................................... NUMBER EXAMINED: 10 10 10 10 10 --HYPERTROPHY. HEPATOCELLULAR: CHARACTERIZED BY AN ACCENTUATED -> 10 10 10 10 10 CENTRILOBULATED PATTERN IN WHICH THE HEPATOCYTES APPEAR TO HAV TL> 10 10 10 10 10 0 0 0 A MORE HOMOGENEOUS CYTOPLASM AND THE CELL BORDERS ARE MORE ROUNDED GIVING THE CELLS A MORE `PLUMP' APPEARANCE. EXCEPT FOR THIS `ENLARGED* APPEARANCE, THE CELLS ARE OTHERWISE `NORMAL*. --HYPERPLASIA.BILE DUCT 2-,> 10 0 9 10 10 10 100 0 TL> 10 10 10 10 10 0 0 0 LF. TESTIS (TEO) ...................................... NUMBER EXAMINED: 10 10 10 10 10 --ATROPHY/DEGENERATION -> 10 9 9 9 10 2> 0 1 0 0 0 3> 0 0 1 1 0 TL> 10 10 10 10 10 0 0 0 0 0 --INFLAFWATION, GRANULOMATOUS -> 10 10 10 10 10 TL> 10 10 10 10 10 0 0 PROSTATE (PRI ...................... , --INFLAMMATION, CHRONIC ACTIVE ........... NUMBER EXAMINED: 10 10 10 10 10 -> I 10 10 10 1 2> 2 0 0 0 1 5> 0 0 0 0 1 TL> 10 10 10 10 10 0 0 0 0 0 HWI 6329-100 PRINTED: II -OCT-91 TABLE.PAGE: 33.2 A F F E C T E D --- S8TG0 oo /sSTOO HAZLETON LABORATORIES AMERICA, INC. MADISON. WISCONSIN U S A . TABLE 33 INCIDENCE OF SEVERITY OF MICROSCOPIC OBSERVATIONS 22 WEEK SACRIFICE TABLE INCLUDES: SEX-ALL;GROUP-ALL;SCREEN-ALL;WEEKS-ALL DEATH-U:FIND-ALL;SUBSE TALL ORGAN/TISSUE EXAMINED N UM B E R -0 F -A N SEX: --MALE GROUP: -1- -2- -3- -4- -5- -6- NUMBER: 10m -10- 10 10-- -10- *0m SEMINAL VESICLE | S V ) .................... ............. NUMBER EXAMINED: 10 10 10 10 10 0 COAGULATING OLD ICG) .................... ............ NUMBER EXAMINED: 10 10 10 10 10 URETHRA (UR) ............................ ............. NUMBER EXAMINED: 10 10 10 10 10 KIDNEY(S) (KD) .......................... ............ NUMBER EXAMINED: 0 0 0 1 0 --DILATATION,PELVIC P> 0 0 0 1 0 TL> 0 0 0 1 0 SKIN (SK| ............................... ............ NUMBER EXAMINED: 1 0 0 0 0 --DERMATITIS 5> 1 0 0 0 0 TL> 1 0 0 0 0 --ULCERATION 5> 1 0 0 0 0 TL> 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 SPLEEN (SP) ............................. ............. NUMBER EXAMINED: 1 --CYST, SEROSAL P> 0 0 0 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 MAXDIB/CERV LN (MN) ..................... --HYPERPLASIA, LYMPHORETICULAR CELL .... NUMBER EXAMINED: 0 0 0 0 1 0 3> 0 0 0 0 1 0 TL> 0 0 0 0 1 0 MESENTERIC LN (MS) ...................... .... NUMBER EXAMINED: 0 0 0 0 0 0 o HWI 6329-100 PRINTED: 11-OCT-R1 TABLE.PAGE: 33.3 HWI 6329-100 Table 34 Summary of Hormone Data Week 5 Mean SD N 8 Mean SD N 14 Mean SD N 22 Mean SD N 0 20.1 - 1 22.6 - 1 b - - b " T-5180 fpom) 1 10 30 Estradiol (oa/mtl 21.0 0.42 2 b - - 26.8 4.56 4 b 34.2 29.1 - - 6.99 16 b 20.9 26.7 - 1.16 4.17 -^ 3 2 28.9 5.23 3 25.3 3.70 5 25.3 7.10 3 100 33.7 9.93 10 36.6 10.43 5 28.2 3.69 4 25.9 2.22 3 0* 21.3 1.70 2 20.5 0.12 3 b - NA NA NA Testosterone fna/ml) 5 Mean 72,400 66,222 59,667 49,200 31,600 42,100 SD 55,580.2 84,812.7 31,815.9 23,403.7 23,735.6 32,370.9 N 10 9 9 10 10 10 8 Mean 46,562 49,913 35,984 73,790 55,680 34,410 SD 39,398.1 66,500.6 22,768.7 103,947.1 35,655.4 38,889.9 N 10 10 10 10 10 10 ^SSTOO ^ a Animal were pair-fed with the high-dose animals throughout treatment, g b Mean is less than 20.0 pg/mL. HW1 6329-100 Table 34 (Continued) Summary of Hormone Oata Week 14 Mean SO N 22 Mean SD N 0 24,578 12,656.3 10 8,714 2,517.6 5 T-5180 (ppm) 1 _10_ 30 Testosterone (na/mL) 35,649 27,614.6 10 31,478 21,909.0 10 23,577 19,074.1 10 21,680 5,669.8 5 11,946 7,885.8 5 13,660 5,981.4 5 100 20,413 14,625.6 10 35,864 38,519.5 5 0* 19,462 16,005.' 10 NA NA NA 5 Mean SD N 8 Mean SD N 14 Mean SD N 22 Mean SD N 0.5 0.19 10 0.5 0.12 9 0.4 0.07 9 0.4 0.17 5 Luteinizing (nq/rnL) 0.7 0.28 10 0.6 0.16 10 0.6 0.19 10 0.6 0.16 9 0.5 0.09 8 0.5 0.14 9 0.5 0.10 10 0.4 0.14 10 0.5 0.19 9 0.4 0.05 4 0.5 0.12 5 0.5 0.32 5 0.5 0.12 8 0.5 0.12 10 0.6 0.45 10 0.6 0.22 4 0.6 0.20 10 0.5 0.20 9 0.4 0.13 10 NA NA NA ^ISSTOO a Animals were pair-fed with the high-dose animals throughout treatment. A -. HWI 6329-100 Table 35 Summary of Test Material Residue Analysis Males Wek 5 8 14 22 Mean SD N Mean SD N Mean SD N Mean SD N _L a a a a a a a a a a a a _2_ 6.5 1.05 8 7.5 1.27 9 7.1 1.15 10 1.2 - 1 T-5180 (ppml group 34 55.4 8.08 9 103.5 14.38 8 45.5 16.20 10 87.3 27.48 10 41.2 12.98 10 70.3 16.18 10 1.09 1.303 3 1.64 0.918 3 159.3 30.16 10 149.1 34.98 10 137.6 33.83 10 2.45 0.849 2 6 a a a a a a a a a . - - a All values were below the limit of detection. ooiss HWI 6329-100 Table 36 Results of Method Validation for Determination of T-5180 in Rodent Food Expressed as the Percent of Recovery Theoretical __ L(oeovrecll 1 1 1 10 10 10 30 30 30 100 100 100 Analytical _As_s_ayiSRMesl_u_lt_s Pay 1 0.810 1.08 0.760 10.4 9.92 9.20 Mean SD CV (%) N 30.1 34.2 30.6 Mean SO CV {%) N Mean SD CV (%) N 99.4 95.0 102 Mean SD CV (%) N Percent Theoretical i%I,_ . 81.0 108 76.0 88.3 17.20 19.50 3 104 99.2 92.0 98.4 6.00 6.10 3 100 114 102 105 7.50 7.10 3 99.4 95.0 102 98.8 3.50 3.60 3 123 < 0i 8 8 f HWI 6329-100 Table 36 (Continued) Results of Method Validation for Determination of T-5180 in Rodent Food Expressed as the Percent of Recovery (Continued) Theoretical Level ___ Lsml___ 1.000 1.000 1.000 Analytical Assay Results ____ ififisQ____ Dav 1 (Continued! 977 972 1,072 Mean SD CV (X) N Percent Theoretical ____ m ____ 97.7 97.2 107 101 5.60 5.60 3 Pay-.? 1 -0.082 1 0.627 1 0.924 r 1.24 r l* 01..29095 Mean SD CV (X) N 111000 10.6 9.85 9.66 Mean SD CV (X) N a Data are from reanalysis of sample. 62.7 92.4 124 99.5 120 99.7 24.60 24.7 5 106 98.5 96.6 100 5.00 5.00 3 124 0018^9 HWI 6329-100 Table 36 (Continued) Results of Method Validation for Determination of T-5180 in Rodent Food Expressed as the Percent of Recovery (Continued) Theoretical Level ___ (ppm)___ 30 30 30 100 100 100 1,000 1,000 1,000 Analytical Assay Results ____ (ppm)____ Day 2 (Continued) 28.8 28.0 28.3 Mean - SD CV (X) N 97.1 93.3 94.3 Mean SD CV (X) N 1,006 955 940 Mean SD CV (X) N Percent Theoretical (%) 96.0 93.3 94.3 94.6 1.30 1.40 3 97.1 93.3 94.3 94.9 2.00 2.10 3 101 95.5 94.0 96.8 3.70 3.80 3 125 00189 HWI 6329-100 Table 37 Results of Stability Analyses Storage Conditions Day of mixing, 12/19/90 Refrigerated, 1 day; room temperature, 7 days Frozen, 2 weeks Frozen, 7 weeks ReDlicate 1 2 Mean 1 2 Mean 1 2 Mean 1 2 Mean _________________________ T-5180 (ppm) 01 10 - 1.27 - 1.39 - 1.33 (133)' 10.0 8.90 9.45 (94.5) - 0.81 - 0.75 - 0.78 (78.0) 11.8 10.8 11.3 (113) 0.75 - 0.78 - 0.77 (77.0) _ 1.20 - 1.47 - 1.34 (134) 10.2 12.2 11.2 (112) 11.1 9.44 10.3 (103) a Values in parentheses are percent of theoretical. 30 28.3 27.7 28.0 (93.3) 28.9 33.7 31.3 (104) 28.7 29.5 29.1 (97.0) 26.6 26.6 26.6 (88.7) 100 93.2 90.3 91.8 (91.8) 109 108 109 (109) 109 112 111 (111) 107 109 108 (108) O o> Q0 JS> HWI 6329-100 Table 37 (Continued) Results of Stability Analyses Storage Conditions* Day of mixing, 03/06/91 Room temperature, 8 days ReDlicate 1 2 Mean 1 2 Mean _________________________ T-5180 (ppm) 01 10 - 0.68 9.09 - 0.76 9.62 - 0.72 (72.0)* 9.36 (93.6) - 0.74 - 0.76 ** 0.75 (75.0) 9.40 9.72 9.56 (95.6) 30 28.9 29.7 29.3 (97.7) 29.5 29.7 29.6 (98.7) 100 96.7 94.0 95.4 (95.4) 94.1 94.6 94.4 (94.4) a Storage condition reflect actual conditions that samples were stored from Weeks 1 through 8. b Values in parentheses are percent of theoretical. *<6ST00 t-oo HW I 6329-100 Table 38 Results of Homogeneity Analyses Sample Location Top Left Right , Bottom ReDlicate 1 2 1 2 1 2 1 2 _________________________ T-5180 (ppm) 01 10 - 0.72 (72.0)* 11.6 (116) 0.65 (65.0) 12.0 (120) - 0.95 (95.0) 10.7 (107) - 0.88 (88.0) 10.9 (109) - 1.21 (121) - 1.54 (154) 12.8 (128) 11.6 (116) - 0.85 (85.0) 11.9 (119) - 0.84 (84.0) 12.7 (127) 30 31.3 (104) 29.8 (99.3) 29.4 (98.0) 31.1 (104) 34.2 (114) 30.5 (102) 28.7 (95.6) 31.0 (103) a Values in parentheses are percent of theoretical. 100 104 (104) 106 (106) 114 (114) 119 (119) 107 (107) 106 (106) 106 (106) 110 (110) rv> Of) 00 HWI 6329-100 Table 38 (Continued) Results of Homogeneity Analyses" Sample Location Top Left Right Bottom Reolicate 1 2 1 2 1 2 1 2 _________________________ T-5180 (ppm) 01 10 0.84 (84.0)b 0.88 (88.0) 0.88 (88.0) 0.86 (86.0) 0.73 (73.0)c 0.74 (74.0)' 0.71 (71.0) 0.87 (87.0) 30 - - " a Reanalyzed, 01/07/91. b Values in parentheses are percent of theoretical. c Results are from a reanalysis on 1/15/91. 100 - - - * - - * - /^68T00 NlO HUI 6329-100 Table 39 Results of Dose Preparation Analyses Week R e d icate 0 T-5180 (ppm) 10 30 1 1 - 0.80 (80.0)" 11.6 (116) 28.9 (96.3) 2 - 1.19 (119) 11.4 (114) 29.5 (98.3) 2 1 - 0.80 (80.0) 9.73 (97.3) 32.2 (107) 2 - 0.91 (91.0) 10.8 (108) 33.0 (110) 31 ,2 41 2 0.91 (91.0) 10.1 (101) - 0.74 (74.0) 11.5 (115) 34.9 (116) 31.4 (105) _ 0.73 (73.0) 11.5 (115) 30.4 (101) - 0.74 (74.0) 9.88 (98.8) 30.6 (102) 4b 1 2 _ 0.88 (88.0) - 0.82 (82.0) 5 1 - 0.86 (86.0) 2 - 0.88 (88.0) 5b 1 2 - 1.10 ( H O) - 1.17 (117) - 6 1 _. 2 -- 9.58 (95.8) 10.4 (104) - a Values In parentheses are percent of theoretical, b Archived sample. 100 111 (111) 102 (102) 100 (100) 108 (108) 98.4 (98.4) 110 (110) 98.0 (98.0) 102 (102) - - OO) jifeSTOd HWI 6329-100 Table 39 (Continued) Results of Dose Preparation Analyses Week Replicate 0 1 T-5180 iDPml _I0_ 30 7 1 -2- - 29.1 (97.0)' - 26.1 (87.0) 8 1 -2 -" -- 9 1 - 0.70 (70.0) 2 - 0.75 (75.0) - _ 10 1 - 2- 10.3 (103) 9.01 (90.1) - 11 1 - 2- - 27.7 (92.3) - 28.8 (96.0) 12 1 - 2" -- -- 13 1 - 0.76 (76.0) - 2 - 0.72 (72.0) - - - 14 1 - 2 -- 9.34 (93.4) 9.45 (94.5) _ - a Values in parentheses are percent of theoretical. 100 - 97.3 (97.3) 96.6 (96.6) _ - - - 90.1 (90.1) 93.2 (93.2) _ - - ^68TGD HW I 6329-100 APPENDIX A Protocol Deviations Protocol TP9321 Protocol Amendment No. 1 Protocol Amendment No. 2 Protocol Amendment No. 3 Material Safety Data Sheet 132 G01S9J HWI 6329-100 Protocol Deviations Protocol Dose Preparation. "All dose preparations will be refrigerated until administration.* Dose Analyses. "Four additional sets of samples will be taken from each dose preparation mixed for Week 1...0ne set will be kept for at least the same period and under the same conditions that are expected to be used for the study, then analyzed." Special Analysis. Test Material Residue Analysis. "An aliquot of serum ...will be collected and stored until analysis for test material residue." Special Analysis. Disposition. "Serum samples will be stored at approximately -70'C until shipment." Termination. "Animals will be anesthetized with methoxyflurane, exsanguinated, and necropsied between 7:00 a.m. and 10:00 a.m." Gross Necropsy. Cut surfaces of the brain and spinal cord will be examined when tissues are trimmed. Actual Procedure During Weeks 1 through 8, diets were stored at room temperature until administration. None of the sets of samples mixed for Week 1 were stored under the same conditions as was used for Weeks 1 through 8, so a second stability analysis was done at Week 12. All serum samples from the Week 22 collection were sent to Hazleton Washington for hormone analysis. The serum remaining after hormone analysis was returned to Hazleton Wisconsin for test material residue analysis. Due to an Insufficient amount of serum remaining after hormone analysis, some groups had serum from less than 10 animals available for test material residue analysis. The location of serum sample storage for 3 collection dates was not documented and cannot be verified. Two animals were not weighed before exsangulnatlon. Three animals were necropsied after 10:00 a.m. The spinal cord was not collected at necropsy; therefore, cut surfaces of the spinal cord were not examined when tissues were trimmed. These deviations are not expected to have affected the results of the study. 133 HAZLETON WISCONSIN 330* KINSMAN B O U L E v AAO POST O F F IC E BOX 754$ MADISON WISCONSIN S3707 O O B N M Q tAOc^nyy Sendees C o ^ -. Sponsor: 3M St. Paul, Minnesota PROTOCOL TP9321 Study Title: 13-Week Dietary Toxicity Study with T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) in Male Rats Date: November 30, 1990 Performing Laboratory: Hazleton Wisconsin, Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704 Laboratory Project Identification: HW1 6329-100 \ j r . > e <J $ 1 I 1 t > G t f ?T> ft y J A P t n . P r > n C U 1 t t 3 ** C -Q -- P n o r e E O S - 2 4 1 ' 4 ^ 1 F u t O i - * ' -7 22 J T e 7 0 3 9 5 6 m a Z P A w V O S 134 coi^<J9 HWI 6329-100 TP9321 Page 2 STUDY IDENTIFICATION 13-Week Oietary Toxicity Study with T-5180, Ammonium Periluorooctanoate (CAS No. 382S-26-1) in Hale Rats Test Material Sponsor Study Monitor Study Director Study Location Proposed Study Timetable In-Life (Experimental) Start Date In-Life Termination Date Experimental Termination Date T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Roger G. Perkins, PhO, DABT 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, Minnesota 55144-1000 Matthew J. Palazzolo, PhD, DABT Hazleton Wisconsin, Inc. P.0. Box 7545 Madison, Wisconsin 53707 (608) 242-2622 Hazleton Wisconsin, Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704 December 20, 1990 May 16, 1991 To be provided by amendment 135 CO19O0 1. Study 2. Purposes 3. Regulatory Compliance 4. Quality Assurance 5. Test Material A. Identification B. Purity C. Stability D. Storage Conditions E. Characteristics F. Reserve Samples G. Safety Precautions HWI 6329-100 TP9321 Page 3 13-Week Oietary Toxicity Study with T5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) in Male Rats To assess the subchronic toxicity of the test material when fed to rats for at least 13 weeks and to evaluate reversibility of any toxic effects This study will be conducted in accordance with the Environmental Protection Agency Good Laboratory Practice Standards, 40 CFR 160. The protocol, study conduct, and final report will be audited by the Quality Assurance Unit in accordance with Hazleton Wisconsin, Inc. (HW1) Standard Operating Procedures (SOPs). T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) To be determined by the Sponsor To be determined by the Sponsor In a dry area, at room temperature Information on synthesis methods, composition, or other characteristics that define the test material is on file with the Sponsor. A reserve sample of each lot will be taken and stored in a freezer. These samples will be transferred to the Sponsor after completion of the inlife phase of the study to be retained in accordance with 40 CFR 160.195. Any remaining test material will be returned to the Sponsor after their authorization. As required by HWI SOPs, unless otherwise specified 136 00130^ HWI 6329-100 TP9321 Page 4 6. Experimental Oesign A. Animals (1) Species (2) Straln/Source (3) Age at Initiation of Treatment (4) Weight at Initiation of Treatment (5) Number and Sex (6) Identification (7) Husbandry (a) Housing (b) Food (c) Water (d) Contaminants (e) Environment (f) Acclimation Rat Crl:CD*BR/Charles River Laboratories, Inc. Preferably 4 to 6 weeks, but not older than 8 weeks Approximately 75 to 250 g 320 males Individually numbered ear tags Individual Certified Rodent Chow #5002 (Purina Hills, Inc.) d libitum, unless otherwise specified. The food is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Ad libitum. Samples of the water are analyzed by HWI for total dissolved solids, hardness, and specified microbiological content and for selected elements, heavy metals, organophosphates, and chlorinated hydrocarbons. There are no known contaminants in the food or water that would interfere with this study. Environmental controls for the animal room will be set to maintain a temperature of 72*F 6*. a relative humidity of 50% 20%, and a 12-hour 1ight/12-hour dark cycle. At least 1 week 137 0013 OpLi' HWI 6329-100 TP9321 Page 5 (8) Randomization Via computer-generated random numbers for assignment to groups. The animals will be weighed. The weight variation of the animals selected for the study will not exceed 2 standard deviations of the mean weight, and the mean body weights for each group will not be statistically different at the 5* probability level. (9) Justification The rat is frequently used in safety evaluation studies as a representative of a rodent species. Hale rats are used to characterize the effects of the test material on testicular physiology. Group Designations Group Dose Level (ppml Number of Males 1 0 55 2 1 55 3 10 55 4 30 55 5 100 55 6 0b 45 a 10 animals for Groups 1 through 5 (designated as recovery animals) will be treated for at least 13 weeks, then treatment will be discontinued and they will be observed for reversibility, persistence, or delayed occurrence of toxic effects for at least 8 weeks posttreatment, b Animals in Group 6 will be pair-fed with the high-dose animals (Group S) throughout the treatment period. Oue to the pair-feeding requirements, the pair-fed control animals (Group 6) will initiate on test 1 day after all other groups. C. Dosing Procedures (1) Dosing Route Dietary (2) Reason for Dosing Route To compare the test data with other studies dosed in a similar fashion. (3) Dosing Duration At least 13 weeks 138 coi9o: HWI 6329-100 TP9321 Page 6 (4) Oose Preparation (5) Oose Analyses (a) Homogeneity (b) Stability (c) Routine Analyses D. Observation of Animals (1) Cageside Observations (2) Antemortem Observations Weekly. All diets will be mixed according to the mixing procedure. Dose concentrations will be based on the test material as supplied. All dose preparations will be refrigerated until being dispensed into food containers. By HWI. Additional samples may be assayed at the discretion of the Study Director. One sample each from all dose levels mixed for Week 1 will be taken from the top, bottom, and two opposing sides of the dose preparation and assayed for test material content. All samples will be stored in a freezer until analyzed. Four additional sets of samples will be taken from each dose preparation mixed for Week 1. One set will be analyzed on the day of mixing. One set will be kept for at least the same period of time and under the same conditions that are expected to be used for the study, then analyzed. The remaining two sets will be stored in a freezer and assayed after 2 and ? weeks. All dose preparations will be assayed each week for the first 4 weeks. Each week thereafter, one test material dose concentration will be selected sequentially. Samples from each 4week period will be analyzed as a group with a sample of the control diet. Mortality and morlbundity check twice dally (a.m. and p.m.). Additional signs of poor health or abnormal behavior will be recorded as they are observed. At least once weekly, each animal will be removed from its cage and examined. 139 (3) Body Weights (4) Food Consumptions E. Special Analysis (1) Hormone Analysis (a) Method of Collection (b) Disposition HWI 6329-100 TP9321 Page 7 Before initiation of treatment, on the first day of treatment, weekly thereafter, and on the day of necropsy Daily for the animals that will be pair-fed (Groups 5 and 6); weekly for all other animals. During recovery, Group 5 animals will be fed weekly. Serum samples will be collected from animals scheduled for sacrifice at each interval for analysis of estradiol, testosterone (total), and luteinizing hormone. Serum samples from 10 animals/group selected at random at each scheduled sacrifice will be analyzed from each sacrifice interval during treatment. Serum samples from 5 animals/group will be analyzed at recovery. The following methods will be used for the hormone analysis: . luteinizing hormone radioimmunoassay Estradiol - Diagnostic Products Kit (DPCKE2D1) Testosterone - Diagnostic Products Kit (DPCTKTTZ) Nonfasted animals will be anesthetized with methoxyflurane; blood will be collected from the descending vena cava and stored on ice (approximately 4*C) until centrifugation. Serum samples will be stored at approximately -70*C until shipment. All samples will be shipped on dry ice to: Denise Novello Immunochemistry Oivision Client Services Section Hazleton Washington 9200 Leesburg Turnpike Vienna, Virginia 22182 140 coiaoif HWI 6329-100 TP9321 Page 8 (2) Test Material Residue Analysis (3) Hepatic Palmitoyl CoA Oxidase F. Termination (1) Unscheduled Sacrifices and Deaths (2) Scheduled Sacrifice G. Postmortem Procedures (1) Gross Necropsy Samples of liver, testes, lungs, and subcutaneous adipose from each animal at necropsy will be collected and stored frozen for possible analysis for test material residue (at an additional cost to the Sponsor; method to be provided by the Sponsor). An aliquot of serum (see Section 6. E. 1. Hormone Analysis) will be collected and stored for possible analysis for test material residue. A section of liver will be obtained from all animals at each scheduled sacrifice and will be flash frozen using liquid nitrogen. A section of liver from S animals/group, selected at random at each scheduled sacrifice will be assayed for the level of palmitoyl CoA oxidase as an indicator of peroxisome proliferation. Necropsies will be done on all animals that die or are sacrificed in a moribund condition. After at least 4, 7, and 13 weeks of treatment, animals (15/group) will be anesthetized with methoxyflurane, weighed, exsanguinated, and necropsied between 7:00 a.m. and 10:00 a.m. For recovery animals (10/group), this will be done after at least 13 weeks of treatment and at least 8 weeks without treatment. The necropsy will include an examination of: External surface of the body All orifices Cranial cavity External surfaces of the brain and spinal cord (Cut surfaces will be examined when tissues are trimmed.) 141 C-01900 (2) Organ Weights (3) Special Analyses (4) Tissue Preservation HWI 6329-100 TP9321 Page 9 Nasal cavity and paranasal sinuses Thoracic, abdominal, and pelvic cavities and viscera For each animal at scheduled sacrifice, the following organs will be weighed; paired organs will be weighed separately: Brain Liver Lungs Testes Accessory sex organs (seminal vesicle, prostate, coagulating gland, urethra) Organ-to-body weight percentages and organ-to*brain weight ratios will be calculated. Samples of liver, testes, lungs, and subcutaneous adipose will be collected from each animal for possible analysis for test material residue. An additional section of liver will be 'collected from each animal for possible analysis of Palmltoyl CoA. (See Section 6. E. 3. Hepatic Palmltoyl CoA Oxidase). The following or representative samples thereof, will be collected and preserved In 10% phosphate-buffered formalin, unless otherwise specified. Samples of these tissues will be preserved in glutaraldehyde for further processing 1f electron microscopic evaluation is desired. Lesions Brain Liver Lungs Testes Accessory sex organs (seminal vesicle, prostate, coagulating gland, urethra) 142 COI9 O9 HWI 6329-100 TP9321 Page 10 (5) Hlstopathology 7. Reports A. Final Report (1) Experimental Design and Methods (2) Results (3) Statistical Analyses The above (as appropriate) will be embedded 1n paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically from all animals from which they are collected A final report including, but not limited to, those items listed below will be submitted. One copy of the draft report and two copies of the final report will be provided. As defined by the protocol, protocol amendments, and any protocol deviations Mortality Antemortem observations Body weights Cumulative body weight gains Food consumption Compound consumption Palmitoyl CoA Organ weights Organ-to-body weight percentages Organ-to-brain weight ratios Macroscopic observations Microscopic observations Body weights Cumulative body weight gains Food consumption Organ weights Organ-to-body weight percentages Organ-to-brain weight ratios Palmitoyl CoA Hormone Analysis Groups 2, 3, 4, and 5 will be compared with Group 1; Group 6 will be compared with Group 5. Statistical methods will be those used by HWI (Attachment 1). 143 coiaotf HWI 6329-100 TP9321 Page 11 (4) Data to be reported (5) Analytical Chemistry 8. Maintenance of Raw Data, Records, and Specimens Incidence of antemortem observations Mean body weights Mean cumulative body weight gains Mean food consumptions Mean compound consumptions Mean group hormone values Mean Palmitoyl CoA Mean organ weights Mean organ-to-body weight percentages Mean organ-to-brain weight ratios Incidence of macroscopic observations Incidence of microscopic observations Individual antemortem observations (to include fate and date of death for each animal) Individual body weights Individual food consumptions Individual Palmitoyl CoA values Individual organ weights Individual organ-to-body weight percentages Individual organ-to-brain weight ratios Individual macroscopic observations Individual microscopic observations Methods and results (if done by HVI) Original data, or copies thereof, will be available at HWI to facilitate auditing the study during its progress and before acceptance of the final report. When the final report is completed, all original paper data, all magnetically encoded records, and a copy of the final report will be retained in the archives of HWI. All specimens will be transferred to the Sponsor to be retained in accordance with 40 CFR 160.195. 144 0190^ PROTOCOL APPROVAL HWI 6329-100 TP9321 Page 12 Aatthar J~ PtUzzolo, Study Director Toxicology Hazleton Wisconsin, Inc. OABT Representative Quality Assurance Unit Hazleton Wisconsin, Inc. Date Dat / RECEIVED DEC 0 6B90 HLA-Madison 145 001310 HWI 6329-100 TP9321 Page 13 Attachment 1 Statistical Analyses The statistical methods that will be used are described below, levene's test (Levene, 1960) will be done to test for variance homogeneity. In the case of heterogeneity of variance at p s 0.05, transformations will be used to stabilize the variance. Analysis of variance (AN0VA) (Winer, 1971) will be done on the homogeneous or transformed data. If the ANOVA is significant, Games and Howell Modified TukeyKramer test (Games and Howell, 1976) will be used for pairwise comparisons between groups. One-way ANOVA will be used (if applicable) to analyze body weights; cumulative body weight gains; food consumptions; Palmitoyl CoA and Hormone Analysis; organ weights; organ-to-body weight percentages; and organ-to-brain weight ratios. If the ANOVA shows significance for body weights at Week 0, one-way analysis of covariance (ANCOVA) (Winer, 1971) will be used to analyze body weights, with the initial body weight as the covariate. Although Levene's test for variance homogeneity will be done (see above), no transformations will be used because covariance adjustment removes extraneous heterogeneity. If the ANCOVA is significant, Games and Howell Modified Tukey-Kramer test will be used for pairwise comparisons between groups. Group comparisons will be evaluated at the 5.0% two-tailed probability level. References Games, P. A., and Howell, J. F., "Pairwise Multiple Comparison Procedures with Unequal N's and/or Variances: A Monte Carlo Study," Journal of Educational Statistics. 1(2): 113-125 (1976). Levene, H., "Robust Tests for Equality of Variances," Contributions to Probability and Statistics, (eds.) I. Olkin et al., Ch. 25, pp. 278-292, Stanford University Press: Stanford, California (1960). Winer, 8. J., "Analysis of Covariance," Statistical Principles in Experimental Desion. Second Ed., Ch. 10, pp. 752-812, McGraw-Hill: New York, New York (1971). Winer, B. J., "Design and Analysis of Single-Factor Experiments," Statistical Principles in Experimental Desion. Second Ed., Ch. 3, pp. 149-260, McGraw-Hill: New York, New York (1971). 146 CQISi/ '=:o5s:- oN=5=V :N= 3ao' <J . .'is*05 v - o S O N .V s c o n s .>. are- HWI 6329-100 .o o m n n o -T- * PROTOCOL TP9321 13-Week Dietary Toxicity Study with T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) in Hale Rats HWI 6329-100 Sponsor 3M Toxicology Services Building 220-2E-02, 3H Center St. Paul, HN 55144-1000 Study Monitor Roger 6. Perkins, PhD, DABT Contractor Hazleton Wisconsin, Inc. 3301 Kinsman Boulevard Madison, WI 53704 Study Director Matthew J. Palazzolo, PhD, DABT Amendment N. 1- This amendment modifies the following portions of the protocol: Effective December 10. 1990 1 Page 6, 6. Experimental Design, C. Dosino Procedures. 141 Dose Preparation, Sentence 3 . To clarify the actual procedure, delete this sentence and replace with the following: All dose preparations will be refrigerated until administration. w - t 3 S I * i C . - * : = - - 3 i * 6 0 6 2 4 >-447i f n 60!'2< ' "227 ; ' I - : t 'J- t 3 < * . 70 39 56 * i Z= i . v ; s 147 00191$. Amendment No. 2 Page 2 HWI 6 3 2 9 - 1 0 0 2. Page 6. 6. Experimental Design, C. Dosino Procedures. (51 Dose Analyses. (c) Routine Analyses. To clarify the actual procedure, delete this section and replace with the following: All dose preparations will be assayed each week for the first 4 weeks. Each week thereafter, the control diet and one test material dose concentration (selected sequentially) will be collected. Samples from each 4-week period will be analyzed as a group. 3. Page 9. 6. Experimental Design. 6. Postmortem Procedures. (31 Special Analyses. To clarify the actual procedure, add the underlined as follows: (3) Special Analyses (scheduled sacrifice animals only! 4. Page 9. 6. Experimental Design. G. Postmortem Procedures. (4) Tissue Preservation. Sentence 2 . To clarify the protocol, add the underlined as follows: Samples of these tissues (scheduled sacrifice animals only) will be preserved in glutaraldehyde for further processing if electron microscopic evaluation is desired. Effective December 31. 1990 5. Pace 6. 6. Experimental Design. C. Dosing Procedures. (51 Dose Analyses. To include the collection of retention samples and a second homogeneity for Diet 2, delete this section and replace with the following: (5) Retention Samples Samples will be taken from the base diet (premix) and from each dose preparation and stored in a freezer for at least 6 months, unless used for analysis. At the discretion of the Study Director, these samples will be returned to the Sponsor or discarded. (6) Dose Analyses By HWI. Additional samples may be assayed at the discretion of the Study Director. (a) Homogeneity One sample each from all dose levels mixed for Week 1 will be taken from the top, bottom, and two opposing sides of the dose preparation and assayed for test material content. Due to a change in the mixing procedure for the 1 ppm level, one sample from the 1 ppm level mixed for Week 3 will also be taken from the top, bottom, and two opposing sides of the dose preparation and assayed for test material content. All samples will be stored in a freezer until analyzed. 148 00193.5 Amendment No. 2 Page 3 HWI 6329-100 (b) Stability (c) Routine Analyses Four additional sets of samples will be taken from each dose preparation mixed for Week 1. One set will be analyzed on the day of mixing. One set will be kept for at least the same period of time and under the same conditions that are expected to be used for the study, then analyzed. The remaining two sets will be stored in a freezer and assayed after 2 and 7 weeks. All dose preparations will be assayed each week for the first 4 weeks. Each week thereafter, the control diet and one test material dose concentration (selected sequentially) will be collected. Samples fpom each 4-week period will be analyzed as a group. Roger4 . Perkins, PhD Oipi ornate, ABT Study Monitor 3M AMENDMENT APPROVAL I/n / n Date R e c e i v e - JAN 2 1991 H azleton W iscon sin Study Director Toxicology Hazleton Wisconsin, Inc. Dati? / __iStLn/i________________________________ Representative Quality As'SiH/ance Unit Hazleton Wisconsin Inc. (ADM/jle) 01/10/91 _______ L'/S> "`ff/ Date 149 091.91^ HAZLETON W333I- iSNjCMiON NeoSjiINo 90S- O f ' . c t SO* 75* S WIO'SON S CONSi N 53707 HWI 6329-100 i O O N N M O u w r m S t n c n C e -cir, PROTOCOL TP9321 13-Week Dietary Toxicity Study with T-5180, Ammonium Periluorooctanoate (CAS No. 3825-26-1) in Hale Rats HWI 6329-100 Sponsor 3M Toxicology Services Building 220-2E-02, 3M Center St. Paul, MN 55144-1000 Study Monitor Roger G. Perkins, PhD, 0ABT Contractor Hazleton Wisconsin, Inc. 3301 Kinsman Boulevard Madison, WI 53704 Study Director Matthew J. Palazzolo, PhD, DABT Amendment No. 2 Effective December 10, 1990 This amendment modifies the following portion of the protocol: 1. Page 9. 6. Experimental Design. G. Postmortem Procedures. (4) Tissue Preservation, and Amendment No. 1. Item 4 . To clarify tissue collection for possible electron microscopic evaluation, delete this section and replace with the following: (4) Tissue Preservation The following or representative samples will be collected and preserved in 10% phosphate-buffered formalin, unless otherwise specified: Lesions Brain Liver Lungs Testes (one testis) . Accessory sex organs (seminal vesicle, prostate, coagulating gland, and urethra) U ! # d S 1 I I I 1 G f ** i n y J 4 P 4 * Prior.# 6 0 8 - 2 4 1 - 4 4 7 1 *l* 608*241-7227 . f r I f: e U r> t o K ; * $ Z Z " T i # 7 0 3 9 5 6 h a ^ r a . - nO S _: GO 150 Amendment No. 2 Page 2 HW I 6329-100 Samples of the following tissues (scheduled sacrifice animals only) will be preserved in glutaraldehyde for further processing if electron microscopic evaluation is desired: Brain Liver Lungs Testes (one testis) Accessory sex organs (seminal vesicle, prostate) AMENDMENT APPROVAL Study Monitor 3M Diplomate, ABT Study Director Toxicology Hazleton Wisconsin, Inc. Representative Quality Assurance Unit Hazleton Wisconsin Inc. (ADM/jle) 01/21/91 Date Oate / 7 Date Received JAN 3 1 1991 H azleton W isco n sin 00131$ HAZLETON WISCONSIN * OI T O ff ic i SOI M4$ M AD ISO N W ISC O N SIN $3707 7445 HHI 6329-100 4 C O R N IN O 14MW4t<wv $ v r.^ CnTr^vir.* PROTOCOL TP9321 13-Week Dietary Toxicity Study with T-5180, Ammonium Periluorooctanoate (CAS No. 3825-26-1) 1n Hale Rats HWI 6329-100 Sponsor 3M Toxicology Services Building 220-2E-02, 3N Center St. Paul, MN 55144-1000 Study Monitor Roger 6. Perkins, PhD, OABT Contractor Hazleton Wisconsin, Inc. 3301 Kinsman Boulevard Madison, HI 53704 Study Picsc-tor Matthew J. Palazzolo, PhD, OABT Amendment No. 3 This amendment modifies the following portions of the protocol: Effective November 30. 1990 l. Pa93_2...STWYIDSHTifLCftllflN Proposed Studg-IteetiH * , Experimental Termination Date. Because the final date of data collection has been determined, delete *To be provided by amendment* and replace with the following: March 29, 1993 Effective April 8. 1991 2. Page 8. 6. Experimental Design. E. Special Analysis 121 Test Material and Residue Analysis. Sentence 2 . At the Sponsor's request to analyze serum for test material residue, delete this sentence and replace with the following: An aliquot of serum (see Section 6. E. 1. Hormone Analysis) will be collected and stored until analysis for test material residue. ^P O n I 60824144*' F r, s v ? " E S S M A 1I 0 i ,, , * 3 3 0' r n $ / 4 N l O J l t U * : r j * 609 2 4 * 7 2 2 * M 0 - 5 * *. *.\ 'A s* \ S .?. ` * *,'4 152 COlSl Amendment No. 3 Page 2 Study Monitor 3M AMENDMENT APPROVAL HWI 6329-100 3 Toxicology Hazleton Wisconsin, Inc. '-Pd/iA. Representative Quality Assurance Unit Hazleton Wisconsin Inc. 153 coiaig 3H Gtntral Office JR Center St. Paul, RN 55144-1000 (412) 733-1110 Dun No.I 00-417-3062 haterial safety DATA SHEET facsihile copy HWI 6329-100 DIVISION! INDUSTRIAL CHEHICAL PRODUCTS DIVISION TRADE NAHEi FC-143 FLUORAD Brand Fluorocheaical Surfactant 3R I.D. NURBERi 79-0211-0008-0 P8-02I1-0347-0 78-0211-0871-7 78-0211-1522-7 ZF-0002-0378-4 ISSUED! Harct) 28, 1787 SUPERSEDES! July 27, 1788 DOCUHENTi 10-3809-2 1. INGREDIENTS CAS NO. EXPOSURE U N I T S PERCENT VALUE UNIT TYPE AUTH Aaooniua Ptrfluoroalkyl Carboiylato Aaooniua Ptrfluoroalkyl Carboaylato Aaaoniua Parfluoroalkyl Carboiylat Aaaoniua Parfluoroalkyl Carboiylat* 3825-24-1 4130-43-4 21415-47-4 48257-11-0 w 7S.0-100.0 0.1 < 5.0 0.1 < 5.0 0.1 < 5.0 0.1 aq/a3 aq/a3 aq/aS aq/aS - TMA TMA TMA TMA SOURCE OF EXPOSURE LIAIT DATA! - ACOIHt Aaerican Conforme* of Sovernamtal Industrial Hyqlenlst - 3Ni 3R Eipoturo Guidelines ACGIH 3R 3R 3R 2. PHYSICAL DATA BOIL2NQ POINT................. .. VAPOR PRESSURE............... N/A VAPOR DENSITY!................. N/A EVAPORATION RATCi.............. N/A SOLUBILITY IN MATERI.... . >10 * SPECIFIC GRAVITY!............. 0.377-0.500 (Bulk) PERCENT VOLATILE.............. N/A VOLATILE 0 R 8 M U C S I ............. N/D pH !............... CA. 5.00 (0.5* Aqueous) VISCOSITY!......................N/D APPEARANCE AND ODORI Llqht colortd pouderj sllght odor. 3. FIRE AND EXPLOSION HAZARD DATA FLASH POINTi.................. Non-Flaaaable FLARRABILITY LIAIT -LELi..... N/A FLARRABILITY L1R1T -UELl..... N/A AUT0I6N1TI0N TERRERATURE ...... N/D EXTINGUISHING HEDIA! Matar, Foao, C02. Dry Cheaical fikk-o tMAR W/A Aa foi ->8d W JfR > it f 154 C019^ MSDSi F C - H 3 FLUORAD Brand Fluorochoaical Surfactant Mar-28-lW 3. FIRE AND EXPLOSION HAZARD DATA (continued) 3M PAGE 2 --------------- H W I g 3 2 9 . 1 0 0 SPECIAL FIRE FIGHTING PROCEDURESt Non* Known UNUSUAL FIRE AND EXPLOSION HAZARDS! H*at of fir* aay r*l*as* a u o n i a and HF. d. REACTIVITY DATA STABILITY! Stable INCOHPATABILITY - MATERIALS TO AVOID! NA HAZARDOUS POLYHERIZATIONI Mill Mat Occur HAZARDOUS DECOMPOSITION PRODUCTS! Th*raal decoapotition aay product toxic aattrial* including HF. 3. ENVIRONMENTAL INFORMATION SPILL RESPONSE! Obttrv* prvcaution* froa oth*r **ction*. Usa toiic dust aatk. Ut* a*t sweeping coapound, or wat*r to avoid dusting. Collect spi1ltd aattrial. Placo in a clottd containor. RECOMMENDED DISPOSAL! Rii with flaaaablt aattrial and incintratt in an industrial or coaaoreial facility. Coabustion products ili includ* HF. Discharg* spont solutions to a aasttaattr tr*ata*nt systoo. Roduc* discharg* rat* if foaaing occurs. Sinct rtgulations vary, consult applicablt r*gulations or authoritits btfor* disposal. U.S. EPA Hazardous Mast* No.I Non* ENVIRONMENTAL DATA! Chtaical Oiyg*n D*aand (COD)i Nil (700 ag/Kg)| 20-Day lioehtaical Oxygon Doaand (B0D20)i Nil| fd-Hr. LCSO, lluogill Sunfish (Lopoait aacrochirus)! Sdt ag/L| fd-Hr. LCSO, Fathtad Minnoa(Pia*phal*S proa*las)I 76* ag/L| dG-Hr ECSO, Daphnia aagnaz 032 ag/L| Id-Day ECSO (coll dry waight), 6rttn Algat (S*l*nastrua capricornutua) 73 ag/L. SARA HAZARD CLASS! FIRE HAZARD! No PRESSURE! No REACTIVITY! No ACUTEi Yts CHRONICi Yt* 0. SUGGESTED FIRST AID EYE CONTACT! laatdiattly flush vitti pltnty of vator. Continuo for 10 oinutts. Call a physician. SKIN CONTACT! Mash afftcttd aroa vith soap and vattr. INHALATION! If syaptoas occur, r*aov* parson to frtsh air. If syoptoos continu*, call a physician. INGESTION! DO NOT INDUCE VOMITING. Givo copious aaounts of vattr. M E D I A T E L Y call a physician or Poison Control Cantor. OTHER FIRST AIDi Abbreviations! N/D - Not D*t*rain*d H /t - Not Applicable 155 001920 nSDSs FC-143 FLUORAD Brand Fluorochemicai Surfactant Har-28-lt8f PAGE 3 A. SUGGESTED FIRST AID NOKC 7. PRECAUTIONARY INFORMATION Use only in oil ventilated areas uith sufficient local exhaust vontilation to Maintain alrborno levels at recognised health and safety levels. Do not breathe dust. Do not set poeder or airborne dust in eyes) wear personal eye protection. Do not get on skin} eear impervious gloves and protective clothing. Wash hands thoroughly after use before eating or drinking. Do not take internally. Launder contaeinated clothing before refuse. NOTES FC-143 uas fed to albino rats for 2 years} no compound Induced carcinogenicity earn found in the study. There uere statistically significant compound related benign testicular tumors. Based on current knouledgei the findings have no human health implications. P REVENT MOISTURE CONTAMINATION TO KEEP POWDER FREE FLOWING. SPECIAL PROTECTION CYC PROTECTIONS Safety Goggles SKIN PROTECTIONS Rubber gloves protective clothing. VENTILATIONS Local eihaust ventilation should be used to control airborne dust. RESPIRATORY PROTECTIONS Toxic dust or supplied air respirator if dust is not mell controlled. ADDITIONAL EXPOSURE LIMITS ~ EXPOSURE L I M I T S ----! INGREDIENTS VALUE UNIT TYPE AUTM 3M K y i 5329-100 Ammonium Perfluoroalkyl Carboxylate 0.1 og/m3 TWA 3M SOURCE OF EXPOSURE LIMIT DATAs - ACGIHs American Conference of Governmental Industrial Hygienists - 3Ms 3M Exposure Guidelines 8. HEALTH HAZARD DATA EYE CONTACTS FC-143 can be irritating to the eyes upon direct contact. Animal studle* Indicate FC-143 Is moderately irritating to the eyes. Airborne FC-143 may cause eye injury consisting of corneal opacity. SKIN CONTACTS FC-143 may be absorbed through the skim. Slightly toxic uhen absorbed through the skin. FC-143 is non-irritating to the skin. INHALATIONS FC-143 may cause respiratory system irritation from inhalation of dust. FC-143 can be considered moderately toxic by inhalation on a single exposure} a median lethal concentration for a 4-hour exposure in the albino rat is ftO milligrams per cubic meter. Repeated inhalation exposure produced liver changes and elevated blood organofluoride levels in rats. INGESTIONS FC-143 is considered moderately toxic from a single oral exposure. The acute oral LDSO (rat) is 340 milligrams per kilogram of body uelght. FC-143 is not teratogenic (rats or rabbits). See Abbreviationss N/D - Not Determined N/A - Net Applicable 156 00192 HSDSi F C - H 3 FLUORAD 8rand Fluorocheoical Surfactant Har-28-lt8t 8. HEALTH HAZARD SATA (continued) precaution for result of 2 year study. RAGE 4 OIY5 HWI 6329-100 Abbreviation! N/9 - Not Determined N/A - Not Applicable The information on this Data Sheet represents our current data and best opinion as to the proper use and handling of this oaterial under noraal conditions. Any use of the oaterial uhieh is not in eonforaance with this Data Sheet or hich involves using the aetertal in coebinatlon with any a* ' `or * x d b f i j * r sr j n v * t h i b r % QQr\ * jb 1 1 1 tV O f t h # y $ # r . 157 CO102p^ HWI 6329-100 APPENDIX B Individual Antemortem Observations Individual Body Weights (g) Individual Food Consumption (g/wk) NOTE: Only observations other than normal are indicated in the Individual Antemortem Observations tables. 158 G019 AN IHAL NUMBER 67451 67452 67452 67452 67453 67454 67454 67455 67456 67456 67457 67458 67459 67459 67460 67461 67461 67462 67463 67463 67464 67464 67465 67465 67465 67466 67467 67468 67469 HUI 6329-100 INDIVIDUAL ANTENORTEN OBSERVATIONS CROUP 1 - 0 PPH T-S180 - HALES UEEK OBSERVATION LOCATION 6 INTERIH SACRIFICE 01/25/91 1 MALOCCLUSION 3 ALOPECIA 22 RECOVERY SACRIFICE 05/17/91 21 RECOVERY SACRIFICE 05/16/91 2 ALOPECIA 14 TERMINAL SACRIFICE 03/26/91 8 INTERIM SACRIFICE 02/14/91 20 CHROMODACRYORRHEA RIGHT EYELID 21 RECOVERY SACRIFICE 05/16/91 5 INTERIM SACRIFICE 01/24/91 8 INTERIM SACRIFICE 02/14/91 9 SMALL MOVABLE TISSUE MASS HIND RIGHT VENTRAL 14 TERMINAL SACRIFICE 03/26/91 14 TERMINAL SACRIFICE 03/25/91 3 ALOPECIA 5 INTERIM SACRIFICE 01/23/91 14 TERMINAL SACRIFICE 03/25/91 3 ALOPECIA 8 INTERIM SACRIFICE 02/12/91 4 ALOPECIA 6 INTERIM SACRIFICE 01/25/91 3 ALOPECIA 3 BLOODY CRUST NECK 8 INTERIM SACRIFICE 02/13/91 8 INTERIM SACRIFICE 02/13/91 6 INTERIM SACRIFICE 01/25/91 5 INTERIM SACRIFICE 01/23/91 8 INTERIM SACRIFICE 02/13/91 159 ANIMAL NUMBER 67470 67471 67472 67473 67474 67475 67476 67476 67477 67473 67478 67479 67479 67479 67480 67481 67482 67482 67483 67483 67484 67485 67486 67487 67488 67*89 67490 HUI 6329-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 1 - 0 PPH T-5180 - MALES UEEK OBSERVATION LOCATION 14 TERMINAL SACRIFICE 03/26/91 22 RECOVERY SACRIFICE 05/17/91 8 INTERIM SACRIFICE 02/13/91 14 TERMINAL SACRIFICE 03/25/91 8 INTERIM SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/22/91 4 MALOCCLUSION 6 INTERIM SACRIFICE 01/25/91 6 INTERIM SACRIFICE 01/25/91 4 ALOPECIA 8 INTERIM SACRIFICE 02/14/91 3 ALOPECIA 4 MALOCCLUSION 22 RECOVERY SACRIFICE 05/17/91 8 INTERIM SACRIFICE 02/12/91 8 INTERIM SACRIFICE 02/12/91 6 MALOCCLUSION 14 TERMINAL SACRIFICE 03/22/91 16 ALOPECIA 21 RECOVERY SACRIFICE 05/16/91 8 INTERIM SACRIFICE 02/12/91 14 TERMINAL SACRIFICE 03/22/91 5 INTERIM SACRIFICE 01/23/91 14 TERMINAL SACRIFICE 03/25/91 14 TERMINAL SACRIFICE 03/26/91 INTERIM SACRIFICE 01/24/91 21 RECOVERY SACRIFICE 05/16/91 160 ANIMAL NUMBER 67491 67492 67493 67493 67493 67493 67494 6749S 67496 67496 67497 67498 67499 67499 67499 67500 67501 67502 67503 67504 67505 HUI 6329-100 INDIVIDUAL ANTEHORTEH OBSERVATIONS CROUP 1 - 0 PP T-S180 - ALES UEEK OBSERVATION LOCATION 5 INTERIM SACRIFICE 01/23/91 5 INTERIM SACRIFICE 01/24/91 2 SORES NECK 3 ALOPECIA 9 BLOODY CRUST NECK 22 RECOVERY SACRIFICE 05/17/91 8 INTERIM SACRIFICE 02/14/91 8 INTERIM SACRIFICE 02/12/91 20 UART-LIKE LESION HEAD 21 RECOVERY SACRIFICE 05/16/91 22 RECOVERY SACRIFICE 05/17/91 8 INTERIM SACRIFICE 02/23/91 2 BLOODY CRUST NECK 3 ALOPECIA 14 TERMINAL SACRIFICE 03/26/91 5 INTERIM SACRIFICE 01/23/91 14 TERMINAL SACRIFICE 03/25/91 6 INTERIM SACRIFICE 01/25/91 5 INTERIM SACRIFICE 01/24/91 14 TERMINAL SACRIFICE 03/22/91 14 TERMINAL SACRIFICE 03/22/91 161 C0192& ANIMAL NUMBER 67506 67507 67508 67509 67510 67511 67S11 67511 67512 67513 67514 67515 67516 67517 67517 67518 67519 67520 67520 67521 67521 67521 67521 67521 67521 67522 67523 67523 HUI 4389-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 2 - 1 PPM T-S180 - NALES UEEK OBSERVATION LOCATION 6 INTERIN SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/22/91 21 RECOVERY SACRIFICE 05/16/91 5 INTERIN SACRIFICE 01/24/91 5 INTERIN SACRIFICE 01/24/91 1 ALOPECIA 1 BLOOOY CRUST NECK 5 INTERIN SACRIFICE 01/24/91 8 INTERIN SACRIFICE 02/13/91 22 RECOVERY SACRIFICE 05/17/91 5 INTERIN SACRIFICE 01/24/91 5 INTERIN SACRIFICE 01/24/91 21 RECOVERY SACRIFICE 05/16/91 20 NALOCCLUSION 22 RECOVERY SACRIFICE 05/17/91 14 TERNINAL SACRIFICE 03/26/91 14 TERMINAL SACRIFICE 03/26/91 4 NALOCCLUSION 22 RECOVERY SACRIFICE 05/17/91 1 ALOPECIA 1 BLOODY CRUST NECK 2 SORES BACK 2 BLOODY CRUST BACK 3 SORES NECK 14 TERMINAL SACRIFICE 03/22/91 8 INTERIN SACRIFICE 02/12/91 8 SOFT FECES 14 TERMINAL SACRIFICE 03/26/91 ANIMAL NUMBER 67524 67524 67525 67526 67527 67528 67529 67530 67530 67530 67530 67531 67532 67532 67532 67533 67534 67534 67535 67536 67537 67538 67538 67538 67538 67538 67539 67540 67541 HUI 6369-100 INDIVIDUAL ANTEHORTEM OBSERVATIONS CROUP 8 - 1 PPH T-S180 - HALES WEEK OBSERVATION LOCATION 4- ALOPECIA 5 INTERIM SACRIFICE 01/23/91 5 INTERIM SACRIFICE 01/23/91 14 TERMINAL SACRIFICE 03/25/91 8 INTERIM SACRIFICE 02/13/91 22 RECOVERY SACRIFICE 05/17/91 5 INTERIM SACRIFICE 01/24/91 1 ALOPECIA 1 BLOODY CRUST HEAD 3 SORES HEAD 5 INTERIM SACRIFICE 01/23/91 8 INTERIM SACRIFICE 02/12/91 3 ALOPECIA 3 BLOODY CRUST HEAD 8 INTERIM SACRIFICE 02/12/91 14 TERMINAL SACRIFICE 03/25/91 4 ALOPECIA 21 RECOVERY SACRIFICE 05/16/91 14 TERMINAL SACRIFICE 03/22/91 14 TERMINAL SACRIFICE 03/22/91 5 INTERIM SACRIFICE 01/24/91 5 ALOPECIA 5 BLOODY CRUST ABDOMEN 5 BLOODY CRUST LEFT FORELEG 7 BLOODY CRUST RIGHT FORELEG 21 RECOVERY SACRIFICE 05/16/91 8 INTERIM SACRIFICE 02/14/91 8 INTERIM SACRIFICE 02/12/91 14 TERMINAL SACRIFICE 03/22/91 CGI92^ ANIMAL NUMBER 67542 67543 67543 67543 67544 67545 67546 67547 67548 67549 67549 67549 67550 67551 67551 67552 67553 67553 67554 67555 67556 67557 67558 67559 67559 67559 67560 HUI *329-100 INDIVIDUAL ANTEMORTE OBSERVATIONS CROUP 2 - 1 PPM T-5180 - HALES WEEK OBSERVATION LOCATION 8 INTERIM SACRIFICE 02/13/91 6 MALOCCLUSION 18 MISSINO TEETH 21 RECOVERY SACRIFICE: 05/16/91 6 INTERIM SACRIFICE 01/25/91 8 INTERIM SACRIFICE 02/14/91 8 INTERIM SACRIFICE 02/13/91 8 INTERIM SACRIFICE 02/14/91 22 RECOVERY SACRIFICE 05/17/91 2 BLOODY CRUST BACK 3 ALOPECIA 14 TERMINAL SACRIFICE 03/25/91 6 INTERIM SACRIFICE 01/25/91 13 SOFT FECES 14 TERMINAL SACRIFICE 03/25/91 14 TERMINAL SACRIFICE 03/26/91 2 MALOCCLUSION 14 TERMINAL SACRIFICE 03/25/91 8 INTERIM SACRIFICE 02/13/91 5 INTERIM SACRIFICE 01/23/91 14 TERMINAL SACRIFICE 03/26/91 8 INTERIM SACRIFICE 02/14/91 5 INTERIM SACRIFICE 01/23/91 3 ALOPECIA 3 BLOODY CRUST NECK 6 INTERIM SACRIFICE 01/25/91 8 INTERIM SACRIFICE 02/12/91 164 OOlSjUJ' ANIMAL NUMBER 67561 67561 67561 67561 67562 67562 67563 67563 67563 67564 67564 67565 67566 67567 67567 67567 67567 67568 67569 67570 67570 67571 67572 67572 67573 67573 67574 67575 67576 67577 67577 HUI 4329-100 INDIVIDUAL ANTEHORTEN OBSERVATIONS CROUP 3 - 1 0 PPM T-S160 - MALES UEEK OBSERVATION LOCATION 2 ALOPECIA 2 SORES HEAD 2 BLOODY CRUST HEAD 22 RECOVERY SACRIFICE 05/17/91 4 ALOPECIA 6 INTERIM SACRIFICE 01/25/91 2 SORES NECK 2 BLOODY CRU8T NECK 14 TERMINAL SACRIFICE 03/22/91 3 MALOCCLUSION 14 TERMINAL SACRIFICE 03/25/91 6 INTERIM SACRIFICE 01/25/91 5 INTERIM SACRIFICE 01/24/91 16 MALOCCLUSION 16 EPISTAXIS 18 HISSINC TEETH 21 RECOVERY SACRIFICE 05/16/91 5 INTERIM SACRIFICE 01/24/91 5 INTERIM SACRIFICE 01/24/91 6 MALOCCLUSION 8 INTERIM SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/22/91 20 SWOLLEN TAIL 22 RECOVERY SACRIFICE 05/17/91 18 MALOCCLUSION 22 RECOVERY SACRIFICE 05/17/91 6 INTERIM SACRIFICE 01/25/91 21 RECOVERY SACRIFICE 05/16/91 5 INTERIM SACRIFICE 01/23/91 3 MALOCCLUSION 5 INTERIM SACRIFICE 01/23/91 165 00193$ ANIMAL NUMBER 67578 67579 67580 67581 67582 67583 67584 67585 67586 67587 67588 67588 67589 67590 67590 67591 67591 67591 67591 67591 67591 67592 67593 67594 67595 6759S 67596 67597 HUI *329-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 3 - 10 PPM T-S180 - MALES WEEK OBSERVATION LOCATION 8 INTERIN SACRIFICE 02/12/91 21 RECOVERY SACRIFICE! 05/16/91 8 INTERIN SACRIFICE 02/13/91 8 INTERIN SACRIFICE 02/13/91 8 INTERIN SACRIFICE 02/13/91 8 INTERIM SACRIFICE 02/12/91 8 INTERIN SACRIFICE 02/12/91 8 INTERIN SACRIFICE 02/14/91 8 INTERIN SACRIFICE 02/13/91 8 INTERIN SACRIFICE 02/12/91 8 NALOCCLUSION 22 RECOVERY SACRIFICE 05/17/91 21 RECOVERY SACRIFICE 05/16/91 4 ALOPECIA 5 INTERIN SACRIFICE 01/24/91 3 SORES BACK 3 SORES HEAO 3 BLOODY CRUST BACK 3 BLOODY CRUST HEAD 4 ALOPECIA 5 INTERIN SACRIFICE 01/23/91 5 INTERIN SACRIFICE 01/24/91 21 RECOVERY SACRIFICE 05/16/91 8 INTERIN SACRIFICE 02/13/91 3 ALOPECIA 5 INTERIN SACRIFICE 01/23/91 14 TERMINAL SACRIFICE 03/26/91 5 INTERIN SACRIFICE 01/24/91 166 G0193 ANIMAL NUMBER 67598 67599 67599 67600 6760t 67602 67602 67603 67604 67605 67606 67607 67608 67609 67610 676t 1 676t2 67613 67613 67614 67615 HUI 6329-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 3 - 10 PPM T-5180 - MALE8 UEEK OBSERVATION LOCATION 14 TERMINAL SACRIFICE 03/26/91 3 MALOCCLUSION 5 INTERIM SACRIFICE 01/23/91 14 TERMINAL SACRIFICE 03/26/91 6 INTERIM SACRIFICE 01/25/91 2 MALOCCLUSION 8 INTERIM SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/22/91 14 TERMINAL SACRIFICE 03/22/91 14 TERMINAL SACRIFICE 03/26/91 8 INTERIM SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/26/91 14 TERMINAL SACRIFICE 03/25/91 22 RECOVERY SACRIFICE 05/17/91 14 TERMINAL SACRIFICE 03/25/91 14 TERMINAL SACRIFICE 03/25/91 S INTERIM SACRIFICE 02/12/91 2 BLOODY CRUST NECK 14 TERMINAL SACRIFICE 03/22/91 8 INTERIM SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/2S/91 167 00193^ ANIMAL NUMBER 67616 67617 67618 67619 67620 67621 67621 67621 67622 67622 67622 67623 67624 67625 67626 67627 67628 67629 67630 67631 67632 67633 67634 67634 67634 67635 67636 HUI 389-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 4 - 3 0 PPH T-S1S0 - HALES UEEK OBSERVATION LOCATION 14 TERMINAL SACRIFICE 03/25/91 8 INTERIM SACRIFICE 02/13/91 14 TERMINAL SACRIFICE 03/22/91 5 INTERIM SACRIFICE 01/24/91 6 INTERIM SACRIFICE 01/25/91 2 ALOPECIA 2 BLOODY CRUST HEAD 14 TERMINAL SACRIFICE 03/26/91 9 MALOCCLUSION 9 EPISTAXIS 22 RECOVERY SACRIFICE 05/17/91 14 TERMINAL SACRIFICE 03/25/91 14 TERMINAL SACRIFICE 03/26/91 6 INTERIM SACRIFICE 01/25/91 21 RECOVERY SACRIFICE 05/16/91 5 INTERIM SACRIFICE 01/23/91 21 RECOVERY SACRIFICE 05/16/91 8 INTERIM SACRIFICE 02/14/91 6 INTERIM SACRIFICE 01/25/91 5 INTERIM SACRIFICE 01/23/91 5 INTERIM SACRIFICE 01/23/91 6 INTERIM SACRIFICE 01/2S/91 2 ALOPECIA 4 BLOODY CRUST RIGHT FOREPAU 8 INTERIM SACRIFICE 02/12/91 14 TERMINAL SACRIFICE 03/26/91 6 INTERIM SACRIFICE 01/25/91 168 001933 ANIMAL NUMBER 67637 6763S 67639 67640 67641 67641 67642 67643 67643 67644 67645 67646 67647 67648 67649 67649 67649 67649 67649 67650 67651 67651 67651 67652 67653 67653 67653 67654 67655 HUI 4329-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 4 - 3 0 PP T-S180 - HALES WEEK OBSERVATION LOCATION 21 RECOVERY SACRIFICE 05/16/91 6 INTERIM SACRIFICE 02/13/91 8 INTERIM SACRIFICE 02/13/91 5 INTERIM SACRIFICE 01/23/91 2 ALOPECIA 14 TERMINAL SACRIFICE 03/22/91 8 INTERIM SACRIFICE 02/12/91 12 SMALL MOVABLE TISSUE MASS HIND LEFT VENTRAL 14 TERMINAL SACRIFICE 03/25/91 8 INTERIM SACRIFICE 02/12/91 14 TERMINAL SACRIFICE 03/26/91 8 INTERIM SACRIFICE 02/14/91 8 INTERIM SACRIFICE 02/14/91 5 INTERIM SACRIFICE 01/24/91 2 SORES NECK 2 BLOODY CRUST NECK 4 ALOPECIA 7 MALOCCLUSION 22 RECOVERY SACRIFICE 05/17/91 14 TERMINAL SACRIFICE 03/22/91 5 ALOPECIA 16 MALOCCLUSION 22 RECOVERY SACRIFICE 05/17/91 14 TERMINAL SACRIFICE 03/2S/91 12 UART-LIKE LESION HIND LEFT VENTRAL 12 UART-LIKE LESION LEFT HIND PAW 14 TERMINAL SACRIFICE 03/25/91 C INTERIM SACRIFICE 01/24/91 8 INTERIM SACRIFICE 02/14/91 169 ANIMAL NUMBER 67656 67656 67657 67657 67658 67659 67660 67661 67662 67663 67663 67663 67664 67664 67664 67665 67666 67666 67667 67667 67668 67668 67668 67669 67670 67670 67670 HUI 6329-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 4 - 3 0 PPM T-5180 - MALES UEEK OBSERVATION LOCATION 5 SUOLLEN LEFT HIND PAU 8 INTERIM SACRIFICE 02/14/91 4 AL'OPECIA 8 INTERIM SACRIFICE 02/12/91 14 TERMINAL SACRIFICE 03/26/91 5 INTERIM SACRIFICE 01/24/91 22 RECOVERY SACRIFICE 05/17/91 8 INTERIM SACRIFICE 02/12/91 8 INTERIM SACRIFICE 02/13/91 4 SQUINTING RIGHT EYE 4 CHROMODACRYORRHEA RIGHT EYE 5 INTERIM SACRIFICE 01/23/91 7 ALOPECIA 15 SMALL MOVABLE TISSUE MASS HIND RIGHT VENTRAL 21 RECOVERY SACRIFICE 05/16/91 5 INTERIM SACRIFICE 01/23/91 2 MALOCCLUSION 22 RECOVERY SACRIFICE 05/17/91 5 ALOPECIA 8 INTERIM SACRIFICE 02/13/91 5 MALOCCLUSION 5 RH1NORRHEA >4 TERMINAL SACRIFICE 03/22/91 14 TERMINAL SACRIFICE 03/22/91 5 ALOPECIA 19 SMALL MOVABLE TISSUE MASS HIND RIGHT VENTRAL 21 RECOVERY SACRIFICE 05/16/91 170 GOlStttf* ANIMAL NUMBER HUI 329-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP S - 100 PPM T-51B0 - MALES UEEK OBSERVATION LOCATION 67671 67671 67672 67672 67673 67673 67673 67673 67674 67675 67675 67676 67676 67676 67676 67676 67676 67676 67676 67676 67676 67676 67677 67678 67679 67680 67681 67681 67682 67682 67682 67683 3 14 11 14 2 2 4 14 21 4 5 12 13 15 15 15 16 18 20 20 20 22 14 21 14 8 2 6 1 1 5 21 MALOCCLUSION TERMINAL SACRIFICE 03/25/91 MALOCCLUSION TERMINAL SACRIFICE 03/25/91 ALOPECIA BLOODY CRUST BLOODY CRUST TERMINAL SACRIFICE 03/26/91 HEAO RIGHT FOREPAU RECOVERY SACRIFICE 05/16/91 ALOPECIA INTERIM SACRIFICE 01/24/91 SWOLLEN BLOODY CRUST SWOLLEN ' STIFF OOES NOT USE SWOLLEN MISSING THIN HUNCHED POSTURE NECROTIC RECOVERY SACRIFICE 05/17/91 BOTH HIND PAWS TAIL RIGHT FOREPAU TAIL BOTH HIND LEGS BOTH FOREPAUS TIP OF TAIL TAIL TERMINAL SACRIFICE 03/26/91 RECOVERY SACRIFICE 05/16/91 TERMINAL SACRIFICE 03/22/91 INTERIM SACRIFICE 02/12/91 ALOPECIA INTERIM SACRIFICE 01/25/91 ALOPECIA BLOODY CRUST INTERIM SACRIFICE 01/23/91 NECK RECOVERY SACRIFICE 05/16/91 G0193 ANIMAL NUMBER 7684 67684 67685 67685 67685 67685 67686 67687 67688 67688 67688 67688 67688 67688 67689 67689 67690 67691 67691 67692 67693 67694 67694 67694 67695 67696 67697 67698 67699 67700 HU1 389-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 5 - 1 0 0 PPM T-S180 - HALES UEEK OBSERVATION LOCATION 9 MALOCCLUSION 21 RECOVERY SACRIFICE 05/17/91 2 ALOPECIA 2 SORES NECK 2 BLOODY CRUST NECK 4 MORIBUND SACRIFICE 01/16/91 14 TERMINAL SACRIFICE 03/22/91 6 INTERIM SACRIFICE 01/25/91 8 ALOPECIA 10 THIN 10 MALOCCLUSION 10 FEU OR NO FECES 11 SOFT FECES 14 TERMINAL SACRIFICE 03/26/91 3 CROOKED TIP OF TAIL ,5 INTERIM SACRIFICE 01/23/91 5 INTERIM SACRIFICE 01/23/91 10 MALOCCLUSION 14 TERMINAL SACRIFICE 03/25/91 5 INTERIM SACRIFICE 01/24/91 5 INTERIM SACRIFICE 01/24/91 ALOPECIA 2 BLOODY CRUST LEFT FORELEG 21 RECOVERY SACRIFICE 05/16/91 14 TERMINAL SACRIFICE 03/22/91 5 INTERIM SACRIFICE 01/24/91 14 TERMINAL SACRIFICE 03/26/91 6 INTERIM SACRIFICE 01/25/91 e INTERIM SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/25/91 172 00193^ ANIMAL NUMBER HUI *329-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 5 - 1 0 0 PPM T-S1B0 - HALES UEEK OBSERVATION LOCATION 67701 67702 67703 67704 67705 67706 67706 67707 67707 67708 67708 67708 67709 67710 6771 1 67712 67713 67713 67714 67715 67716 67716 67717 67717 67718 67719 67719 67720 21 e 8 22 8 4 22 2 8 1 1 .8 8 8 8 14 4 6 14 5 7 14 2 5 8 3 8 14 RECOVERY SACRIFICE 05/16/91 INTERIM SACRIFICE 02/13/91 INTERIM SACRIFICE 02/14/91 RECOVERY SACRIFICE 05/17/91 INTERIM SACRIFICE 02/13/91 ALOPECIA RECOVERY SACRIFICE 05/17/91 ALOPECIA INTERIM SACRIFICE 02/12/91 ALOPECIA BLOODY CRUST INTERIM SACRIFICE 02/13/91 INTERIM SACRIFICE 02/12/91 INTERIM SACRIFICE 02/14/91 INTERIM SACRIFICE 02/14/91 TERMINAL SACRIFICE 03/26/91 ALOPECIA INTERIM SACRIFICE 01/25/91 TERMINAL SACRIFICE 03/25/91 INTERIM SACRIFICE 01/24/91 ALOPECIA TERMINAL SACRIFICE 03/22/91 ALOPECIA INTERIM SACRIFICE 01/23/91 INTERIM SACRIFICE 02/14/91 MALOCCLUSION INTERIM SACRIFICE 02/12/91 TERMINAL SACRIFICE 03/22/91 NECK 173 C0193g ANIMAL NUHBER 67721 67722 67722 67723 67724 67725 HUI *329-100 INDIVIDUAL ANTEHORTEM OBSERVATIONS GROUP S - 100 PPH T-5180 - HALES UEEK OBSERVATION LOCATION e INTERIN SACRIP1CE 02/13/91 5 MALOCCLUSION 8 INTERIN SACRIFICE 02/12/91 22 RECOVERY SACRIFICE: 05/17/91 e INTERIN SACRIFICE 02/13/91 5 INTERIN SACRIFICE 01/23/91 174 0019 < f ANIMAL NUMBER 67726 67727 67728 67729 67730 67731 67732 67733 67734 6773S 67736 67737 67738 67739 67740 67741 67742 67743 67744 67745 67746 67746 67747 67748 HUI 389-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 6 - 0 PPM T-S180 - MALES UEEK OBSERVATION LOCATION 5 INTERIM SACRIFICE 01/23/91 5 INTERIM SACRIFICE 01/25/91 8 INTERIM SACRIFICE 02/13/91 8 INTERIM SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/25/91 8 INTERIM SACRIFICE 02/12/91 14 TERMINAL SACRIFICE 03/26/91 5 INTERIM SACRIFICE 01/23/91 8 INTERIM SACRIFICE 02/12/91 5 INTERIM SACRIFICE 01/24/91 14 TERMINAL SACRIFICE 03/26/91 8 INTERIM SACRIFICE 02/12/91 14 TERMINAL SACRIFICE 03/25/91 8 INTERIM SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/22/91 5 INTERIM SACRIFICE 01/23/91 5 INTERIM SACRIFICE 01/24/91 8 INTERIM SACRIFICE 02/13/91 14 TERMINAL SACRIFICE 03/26/91 5 INTERIM SACRIFICE 01/24/91 8 SWOLLEN TAIL 14 TERMINAL SACRIFICE 03/25/91 14 TERMINAL SACRIFICE 03/26/91 14 TERMINAL SACRIFICE 03/22/91 175 00194$ ANIMAL NUMBER 67749 67750 67751 67752 67753 67753 67754 67755 67756 67757 67758 67759 67760 67761 67762 67763 67763 67764 67765 67765 67766 67766 67767 67768 67769 67770 HUI 6329-100 INDIVIDUAL ANTEMORTEM OBSERVATIONS CROUP 6 - 0 PPM T-S180 - HALES UEEK OBSERVATION LOCATION 14 TERMINAL SACRIFICE: 03/22/91 8 INTERIM SACRIFICE 02/13/91 5 INTERIM SACRIFICE 01/25/91 8 INTERIM SACRIFICE 02/14/91 0 CHROMODACRYORRHEA RIGHT EYE 8 INTERIM SACRIFICE 02/14/91 14 TERMINAL SACRIFICE 03/25/91 14 TERMINAL SACRIFICE 03/22/91 14 TERMINAL SACRIFICE 03/26/91 5 INTERIM SACRIFICE 01/25/91 8 INTERIM SACRIFICE 02/14/91 5 INTERIM SACRIFICE 01/24/91 14 TERMINAL SACRIFICE 03/22/91 5 INTERIM SACRIFICE 01/25/91 5 INTERIM SACRIFICE 01/23/91 2 ALOPECIA 8 INTERIM SACRIFICE 02/13/91 5 INTERIM SACRIFICE 01/25/91 2 MALOCCLUSION 8 INTERIM SACRIFICE 02/13/91 7 MALOCCLUSION e INTERIM SACRIFICE 02/12/91 14 TERMINAL SACRIFICE 03/25/91 8 INTERIM SACRIFICE 02/12/91 5 INTERIM SACRIFICE 01/25/91 5 INTERIM SACRIFICE 01/25/91 176 00194/ INDIVIDUAL 13 WK DIETARY ' Armor NUMBER 0 ___ 1 2 GROUP 1 MALES CONTROL 67451 67452 67453 67454 67455 67456 67457 67451 67459 67460 67461 67462 67463 67464 67465 67466 67467 67466 67469 67470 67471 67472 67473 67474 67475 67476 67477 87476 67479 67460 67461 67462 67463 67464 67465 67466 67467 67466 67469 67490 67491 67492 67493 209 1 187.1 217.1 206.2 200.4 187 5 202.7 208 4 186.5 210.0 204.1 212.2 205.1 199.3 208 2 210.3 214.1 201.2 208.3 196.9 210.3 201.3 206.3 205.5 208.3 213.3 194.0 204 6 196.0 208.0 197.3 169.7 216.6 208.2 206.7 200.5 193.8 223.0 207.9 203.1 201.7 226.8 169.8 265.0 236 8 280.1 267.3 259 0 243.6 254.7 258.9 243.1 266.0 260 1 269.5 270.0 261.7 287.0 264.7 270.2 262.3 270.8 255.3 270.8 287.3 273.5 263.1 272.3 268.7 250.2 260.4 251.8 266.4 255.1 241.4 277.3 264.6 288.5 261.3 252.4 291.9 261.4 268 1 255.6 290.9 245.4 320.4 294.4 336.7 326.2 311.9 284.7 297.8 304.5 294 7 317.9 306.8 324.1 315.9 323.6 307.5 321.6 315.3 302.6 324.6 312.5 318.5 334.0 337.6 318.4 324.8 321.0 305.3 311.0 302.3 315.3 295.4 284.8 323.0 315.1 321.7 305.0 299.1 345.8 296.6 317.2 296.9 341.2 293.3 DEAD ANIMAL 3 368.1 333.3 380.8 367.7 350.3 325.1 328.4 340.3 331.3 354.8 343 3 361.2 354.2 361.9 338.6 358 9 354.1 339.8 363.3 348.8 354.3 379.0 378.5 355.5 367.0 361 2 349.6 353.0 346.7 349.1 329 8 324.5 354.9 360.0 363.3 339 331 78 392 0 329.8 357.9 331 3 385 4 323.4 4 412.3 369.1 423.0 410.3 392.4 360.8 356.4 375.7 373.9 391.1 389.9 395.9 393.9 398.1 366.0 404.7 393.2 373.8 398.9 379.8 394.0 424.1 423.2 392.4 407.2 394.2 390.7 389.8 367.9 391.5 363.5 355.3 382.8 402.9 405.9 379.6 360.0 435.5 3SS.0 394.6 365.9 424.6 349.3 5 444.5 398.4 459.5 438.9 418.3 388.1 398.1 401.2 422.05 424.9 427 1 426.7 387.9 434.4 423.07 431.5 402.0 425.3 455.9 446.5 424.0 428.8 425.5 425.4 415.7 392.5 418.3 392.3 386.0 413.7 434.5 434.*6 396.2 469.07 421.*1 * 368.9 *tffr6T00 -j BODY WEIGHTS (G) rOXICITY STUDY WITH T-51I0 HWI 6379-100 TEKSr 6 7 4 0 10 11 12 13 * 415.0 444.1 463.4 430.3 407.7 ft 414.5 421.3 437 f.t0 447.0 447.ft5 402.0 459.3 ft ft 453.3 422.5 443.2 441.5 474.1 442.2 4 4 0 .ft0 ft 430.1 407.5 434.3 404.4 300.5 431.4 452.4 4 5 7 .ft0 413.0 4 0 4 .ft0 4 3 4 .ft0 ft 344.3 ft 435 8 508 1 479.7 452.4 424.ft4 420.8 436.5 455.ft6 473.5 464.ft7 414.3 4 7 5 .ft6 ft 476.7 437.1 464.3 504.3 492.2 454.2 4 7 1 .ft5 ft 454.6 430.6 453 0 423.7 411.4 452.4 473.6 4 7 9 .ft4 424 4 5 2 0 .ft4 4 5 4 .ft6 ft 407.6 ft 452 5 527 1 496.ft5 455.7 ft ft 454 2 469.ft2 404.II2 ft ft ft ft ft ft 455 1 4 9 2 .ft1 5 1 7 .ft1 4 0 7 .ft7 ft ft 43 0.fftt6 442 4 4 7 2 .ft2 5 0 6 .ft4 450.3 535.0 ft 4 4 0 .ft0 ft 425.2 ft 477 1 544.4 514.ft6 465.5 ft ft 463.4 445.ft3 520.ft7 ft fftt fftt ft 472.7 517.3 ft 5 4 2 .ft9 5 1 0 .ft1 ft ft 44 9.ft1 ft 454 6 4 9 5 .ft6 52 9 ft4 467 5 555.7 ft 40 4 .fftt1 437.5 ft 440 5 562 5 531.ft4 475 ft6 ft 466 8 501.ft6 540.ft1 ft fftt ft ft ft 445.6 5 2 6 .ft2 5 5 4 .ft0 523.7 ft ft ft 4 5 5 .ft7 ft 473.5 510.0 ft 546.0 ft 461 7 5 6 7 .ft0 5 0 6 .fftt9 446.6 ft 494.5 577.7 540.ft4 444.ft6 ft 461.6 507.ft9 555.ft8 ft ft ft ft ft ft 400.7 5 3 0 .ft0 5 6 0 .ft4 5 4 1 .ft2 ft ft 4 4 6 .ft6 ft 490.2 5 2 0 .ft6 5 6 5 .ft3 406.4 5 4 0 .ft4 5 1 3 .ft4 ft 463 4 . ft 494.9 592.4 553.ft2 406.ft5 ft 440.6 522 ft4 569.ft7 ft ft ft ft ft ft . 496.4 5 4 7 .ft3 5 4 9 .ft6 5 4 9 .ft3 ft ft 44 3 .ft3 ft 497.9 5 3 3 .ft6 5 7 7 .ft2 505 4 597.7 ft 5 2 2 ft6 ft 472.7 ft 507.4 600.4 565 ft3 510.II6 ft 496 5 S 2 6f.t6 566 ft1 ft ft ft ft ft ft 514 4 5 6 5 ft4 5 9 4 ft2 5 6 6 ft4 ft ft 471 1 ft ft 513 4 5 3 9 .ft7 5 4 9 .ft0 514 2 6 1 0 .ft5 5 3 6 fftt8 444 9 ''GTGO INDIVIDUAL BODY WEIQHTS (0) 13 UK DIETARY TOXICITY STUDY WITH T-5110 ANIMAL NUMBER 14 15 18 OROUP 1 MALES CONTROL 7451 674S2 7453 7454 7455 7458 7457 7451 87458 7480 7481 87482 07483 87484 87485 87468 87487 87461 87469 67470 67471 7472 67473 87474 67475 67476 67477 6747 67479 67410 67481 67482 67483 67484 67485 67486 67487 67488 67489 67490 67491 67492 7493 A 512.2 619.3 a 0 517.19 0 * * 0 <8 0 0 0 * 0 0 0 578.3 0 0 1 0 * 490.6 0 0 556.4 0 0 0 0 * * 545.7 A 484.3 0 527.2 623.5 0 525.1 0 0 0 0 0 0 * 0 0 0 0 0 * 0 588.4 0 A A A A A A 509.0 A A A 564.8 A A A A A A 553 5 A A 497.2 A 533.8 631.8 A A 540.4 A A A A A A A A A A A A A A 605 5 A A A A A A A 514.2 A A A 580.1 A A A A A A 566.5 A A 494.4 * DEAD ANIMAL 17 A 540.6 636.8 A A 541.5 A A A A A A A A A A A A A A 615 1 A A A A A A A 526.6 A A A 589.4 A A A A A A 583 5 A A 505.7 1 A 541.4 641.2 A A 543.8 A A A A A A A A A A A A A A 616 1 A A A A A A A 528.1 A A A 585.7 A A A A A A 574.3 A A 507.9 "WEEKS-- 19 20 A 554.7 649.5 A A 557.2 A A A A A A A A A A A A A A 628:1 A A A A A A A 524.6 A A A 597.5 A A A A A A 587.7 A A 509.9 A S55.0 659.7 A A 561.7 A A A A A A A A A A A A A A 838 1 A A A A A A A 517.5 A A A 601.1 A A A A A A 596 0 A A 508.3 21 A 579.0 A A A A A A A A A A A A A A A A A 648.0 A A A A A A A 524.7 A A A A A A A A A A A A A 5110 oo HUI 6329-100 INDIVIDUAL BODY WEIGHTS (Ol 13 WK DIETARY TOXICITY STUDY WITH T-51IO wmwt NUMBER OROUP 67494 67405 67496 67497 67491 67499 67500 67501 67502 67503 67504 87505 ---------------------------------------------wrorc 012345 6 1 MALES CONTROL 206.5 203 6 204.5 187.1 208 5 212 3 216.0 202.6 188.6 197.2 205.9 204.2 258 9 271.6 256.3 242 0 268.3 274 5 269.3 256.0 250 3 259.5 267.2 257.1 305.4 328.2 299.6 294 5 321.6 331 6 317.1 302 5 302.9 309.8 324.6 304.3 333.0 370.4 330.8 341 0 366.9 377 0 3S4.4 338.1 344 4 352.4 362.9 342.6 367.2 406.1 361.6 373.9 410.0 417.3 384.7 373.7 379 4 387.5 403.4 375.2 389.7 433.9 386 8 403.1 438.1 452.4 A 401.2 412.5 A 437.8 402.8 414 4 454 9 404 1 421 1 461.3 479.0 A 415.4 A A 467.0 427.8 7 430.6 474 8 421.6 440.0 488.9 502.6 A 436.7 A A 492.5 44S.2 8 A A 435 4 459.2 A 512.8 A 455 1 A A 509.5 463.3 9 A A 445 2 478.2 A 536.5 A 475.5 A A 522.6 478.7 10 A A 452 7 483 5 A 551 8 A 473.9 A A 559.5 494.8 11 A A 463.8 501.2 A 560 4 A 492.4 A A 573.0 513 2 HWI 6379-100 12 13 A A 469.6 507.2 A 569.1 A 493.1 A A 579 4 527.7 A A 479 8 518.7 A 576.6 A 510 2 A A 596 4 543 9 O O C3 A *45: DEAD ANIMAL u> INDIVIDUAL BOOY WEIGHTS (Ql 13 WK DIETARY TOXICITY STUOV WITH T-S1I0 ANTHAL NUMBER GROUP 67494 67495 67496 $7497 6749$ 67499 67500 67501 67502 67503 67504 67505 14 15 ___ 16__ 1 MALES - CONTROL * A 4SI .9 521.*3 A A A A A A A A A 4*0 8 533.5 A A A A A A A A A A 4SI 1 549.9 A A A A A A A A _V A A 491.S 559.7 A A A A A A A A IS A A 492.S 565.3 A A A A A A A A TJETR5-- 19 20 A A 49S.5 576.2 A A A A A A A A A A 499.2 590.2 A A A A A A A A 21 A A 592.5 A A A A A A A HUI 6379-100 oO DEAD ANIMAL CD INDIVIDUA! 13 WK DIETARY ANIMAL NUMBER 01 GROUP 2 MALES 6750# 67507 67506 67509 67510 67511 67512 67513 67514 67515 67516 67517 67511 67519 67520 67521 67522 67523 67524 67525 67526 67527 67528 67529 67530 67531 67532 67533 67534 67535 67536 67537 67531 67539 67540 67541 67542 67543 67544 67545 67546 67547 67548 202.0 204.4 199.8 223.6 201.3 221.4 200 3 207.9 220 2 192.0 208.3 212.5 201.8 201.2 216.4 202.4 199.3 223.1 185.2 214.8 196.8 195.9 197.6 201.8 223.5 213.1 213.2 201.2 218 0 197.8 208 6 180.7 192.3 201.5 217.1 207.1 194.3 200.0 198.6 200.9 212 6 210.6 190.8 256.0 2 S 9 .1 259 4 287.3 256.4 271.5 248.9 264.3 282.1 240.4 260.5 275.3 254.0 254.3 270.9 259.1 263.8 286 3 235.3 277.2 254.3 257.5 255.2 250.5 279.8 277.5 271.2 261.0 280.1 252 0 264.6 232 6 258.2 258.3 283.2 278.1 245.4 261 2 254.3 259.5 268.7 271 9 243.8 DEAD ANIMAL 23 1.0000 PPM 299.4 309.3 308.2 342 4 303.0 316.2 292.0 305.6 334.1 287.8 311.8 324.4 303.7 301.1 317.2 307.2 318.8 342 2 283.5 330.4 302.3 312 7 298.8 300.5 330.0 329.9 320 2 310.8 330.5 293 3 315.1 275 7 313.8 317.8 343.3 323.7 285.0 317.1 298 2 301 4 311.3 313.7 288.1 331 8 343.6 346 5 390 3 342.0 343.6 325.7 342 5 370.8 328 1 357.7 363.6 333.4 335.4 355.2 339.0 373.0 380.0 321.3 370 3 334.8 353.9 338.7 341.7 372.2 374.2 361.2 350 8 374.8 341.9 346.2 308.0 357.9 381.2 393.6 363.3 314.6 357.9 334 2 333 7 347 9 358 9 321.7 4 363.6 388.9 388.2 432.8 377.5 374.0 361.0 370.8 402.1 365.9 392.6 399.6 365.0 372.7 383.0 373.1 412.3 419.7 357.0 409.9 366.9 389.7 366.0 380.9 401.1 418.4 399.2 385.7 408.6 375.9 385.2 337.9 397.1 398.6 439.3 393.8 351.1 397.7 361.2 360.2 384.8 383.1 353.2 5 394.8 409.5 406.ft9 88 390.0 400.8f8t7 428.4 428.7 382.5 397.2 406.6 402.2 452.0 447.fftt9 389.4 427 9 395.ft5 ft 450.2 431.1 418.8 439.5 403.5 419.ft0 422.9 431.8 477.1 421.7 377.2 432.2 389.4 380.7 418.2 405.5 386.3 C0194 00 . BODY WEIGHTS (Gl TOXICITY STUDY WITH T-S180 HWI 6329-100 T3EEK5----------------------------------------------------6_______ 7_______ 8_______ 9______ 10______ U ______ 12______ 13 413.5 429.5 421.2 * A 411.0 425.*4 A 451.1 445.7 394.7 414.2 421.7 423. 414.7 481.*5 * 404.7 453.1 417.*0 * 478.5 451.5 447.3 482.5 424.2 442.A8 449.5 459 5 504.7 442.7 397.9 440.0 A 400.0 442.5 432 1 399.4 421.0 453.1 441.4 A A A 432.5 449.1 A A 483.1 488.8 407 5 432.0 438.8 4.48.7 513.0 495.9 A A 415.9 477. 437.1 A A 503.7 473.7 48 8 482.3 449.1 482.4 A 471.4 486 9 532.4 458 2 417.0 457.A7 421.2 458.0 439.0 417.4 A 46 3 461.3 A A A A 474 4 A A 505.7 491.6 415.1 454.1 45.7 473.9 A 513 2 A A 433.9 A 449.2 A A A A 465 . 504.9 469.3 469.3 A 491.5 A A 482 7 A 479.9 A A A A 433 4 A 411.5 486.9 A A A A 483.7 A A 529.6 506.4 425.7 467.7 474.0 492.8 A 540 2 A A 453.5 A 467.0 A A A A 503 3 516.3 493.0 505.2 A 507.8 A A 499.9 A 500.1 A A A A 452.7 A 494.0 491.8 A A A A 513.1 A A 543.2 516.6 432.2 474.0 485.5 514.9 A 553.9 A A 465.9 A 477.8 A A A A 524 0 531.7 498.4 518.5 A 527.1 A A 522.5 A 511.2 A A A A 465 0 A 504 8 502.5 A A A A 525.*6 * 564.3 535.1 448.7 487.8 496.5 524.*2 575.*8 * 483 *4 489.m3 * * A 539 3 546 9 516.8 538.0 A 548.8 A A 533 0 A 514.2 A A A A 471 8 A 510.5 505.7 A A A A 539.8 A A 581 8 546.1 459.6 497.0 497.3 540.8 A 566.1 A A' 496.0 A 499.8 A A A A 558 6 550 1 530 1 549.3 A 565 2 A A 545 2 A 510 6 A A A A 475 2 A 536.7 517 6 A A A A 557.8 A A 599.5 560 4 468.7 508 2 5111 559.3 A 606.3 A A 510 0 A 512.5 A A A A 572 8 565 5 548 5 567.7 A 582.5 A A 561 0 A 517.4 A A A A 489 8 001947 INDIVIDUAL BODY WEIGHTS (Gl 13 WK DIETARY TOXICITY STUDY WITH T-S1S0 ANIMAI NUMBER ____U ____ IS GROUP 87506 67507 67501 67509 67510 67511 67512 67513 67514 67515 87516 67517 67511 67519 87520 67521 67522 67523 67524 67525 67526 67S27 8752 67529 67530 67531 67532 67533 67534 67535 67536 67537 67531 67539 67540 67541 67542 67543 67544 67545 67546 67547 67541 2 MALES * A 522 9 A A * * 570 6 a 601. 5 6 9 .ft1 ft 495 fAt0 ft ft ft ft ft 516.3 * * * 573.ft6 ft ft 604.*4 * * 512 2 ft ft ft ft 492.5 ft ft 5 2 1 .ft0 ft ft ft 5 1 4 .1 617.9 57 7 .ft3 ft 524.A * ft i * ft 515.*9 * 513 fftt9 ft 614. ft 517 2 * A 491.7 * DEAD ANIMAL 16 17 1.0000 PPM ft ft 5 3 4 .*4 6 0 0 .2 * 625.6 5 9 3 .fftt1 530.9 ft ft 529.*3 * A 592.ft6 ft ft 640.A ft * 516.0 A A A SOI. 4 ft ft 5 3 1 .ft2 ft ft ft 6 2 1 .i0 * 631. 6 1 1 .ft7 530.ft9 * * ft * ft 533.1 * * 601.ft3 ft ft 641.*2 * * A 514 6 ft ft ft ft 523.3 It ft ft 5 3 7 .ft3 ft ft ft 6 2 2 .i6 * 645.6 612.6 ft ft 531.1 ft * ft * * ft * 537.ft5 ft * * 604.*5 ft 649.A1 ft ft ft 521.8 ft ft ft ft 516.0 'WEEK5-- 19 20 ft ft 5 4 9 .3 A ft 6 3 7 .ft9 ft 656.4 629.*2 * 534.2 i A * A *ft 545.A3 A A * A 606.A6 A A 662.ft7 ft ft ft 535.0 A A A * 537. ft ft 5 5 0 .ft2 ft 6 5 6 .A5 ft 663.4 609.*6 ft 545. ft A ft * 556.ft3 * * * 611.*6 A A 677.A0 A A 511.3 ft ft ft ft 546.7 21 ft A ft ft ft ft ft 673. a a a 617.4 a a 543. ft ft ft ft fftt 564.*2 a a * a a a a a a a a a a a * 550.0 CMD HVI 6329-100 ANIMAL NUMBER GROUP 67549 67550 67551 67552 67553 67554 675S5 67556 67557 67551 87559 67560 0 _______ 1 _____ 2 3 2 MALES 1.0000 PPM 214.7 191.2 209.0 221.9 203.4 211.7 207.4 200.3 211 5 221.5 225.0 206.7 272.0 241.5 276.1 292.2 257.3 276.1 261.9 251.7 293.3 279.3 290.1 261.9 323.4 214.1 337.5 347.2 299.7 322.6 316.5 307.7 331.2 331.7 349.2 310.4 361.1 327.9 390.6 392.1 343.4 364 1 356 1 343.1 374.3 373.2 403.7 345.6 INDIVIDUAL BODY WEIGHTS (Ql 13 WK DIETARY TOXICITY STUDY WITH T-5190 'TTETKS-- 45 6 7 99 405.6 359.9 423.1 419 1 391.9 402.6 399.7 376.4 413.2 409.3 447.6 399.0 443.5 391.1 453.5 452.7 411.7 432.5 A 407.3 445.2 A 492.6 426.9 465.0 A 479.9 475.1 436.4 454.6 A 429.7 462.6 A A 439.9 491.9 A 502.9 502.1 455.2 477.9 A 445.9 492.9 A A 459.2 520.7 A 521 9 529 4 469.9 A A 465.7 A A A A 541 0 A 534 5 553.1 497.6 A A 493.6 A A A A 10 554.7 A 540.3 566 7 517.2 A A 494.9 A A A A 11 589.0 A 552.9 592.9 527.6 A A 507.7 A A A A HUI 6329-100 12 13 591.9 A 564.7 595.2 540.9 A A 517.2 A A A A 601.5 A 574 9 599.9 549.7 A A 527 9 A A A A $fr6T09 * DEAD ANIMAL 0to0 INDIVIDUAL BODV WEIGHTS (O) 13 WK DIETARY TOXICITY STUDY WITH T-5110 ANTHAT HUMBER GROUP 87549 67550 87551 87552 87553 67554 67555 67556 67557 67551 67559 67560 ------------------------------------------------- WTTK5-------14______ 15______ 16______ 17______ ______ li______ 20______ 21 2 MALES - 1.0000 PPM* HUI 6329-100 * DEAD ANIMAL oo INDIVIDUAI 13 WK DIETARY ANIMAI NUMBER 0 1 ____ 2___ 3 GROUP 3 HALES 10.0000 PPM 675*1 7562 7563 7564 67565 7566 7567 7566 6756 67570 67571 7572 67573 67574 67575 7576 67577 7576 757 7560 7511 752 7563 7564 67565 7566 67567 67566 6756 675S0 67591 7592 67593 7594 7595 7596 7597 67596 67599 67600 67601 67602 67603 204.6 211.3 214.7 221.2 195.9 203.2 213.0 205.3 164.6 216.7 161.1 212.6 205.3 199.3 193.9 200.4 207.3 206.4 169.0 213.4 210.1 206.6 196.6 209.4 166.2 162.4 21 6 166.3 194.2 197.4 195 1 190.1 197.7 211.6 199.2 165.0 166.5 166 3 209.6 212.4 210.7 220.7 216.0 259.7 272.4 262.2 263.5 250.4 263.0 271.2 256.5 242.7 293.2 232. 270.3 256.4 251.0 249.5 251.1 260.2 266.6 245.4 262.5 266.9 262.9 247.6 266.3 241.5 230.6 276.6 242.9 255.0 249.6 246.6 235.7 255.1 277.5 254.3 234.3 242.0 239.1 265.7 276.5 276.0 266.2 263.0 306.1 320.4 256.6 333. 295.4 234.2 323.1 226.2 292.3 340.0 262.4 315.4 304.5 299.4 308. S 299.0 296.9 312.2 292.3 305.3 316.3 311.0 288.9 321.2 285.6 273.5 324.0 289.5 311.5 300.0 294.2 270.8 314.0 334.8 308.4 279.2 262.6 288.6 312.4 330.6 337.0 337.7 254.7 345.2 366.1 378.6 376.5 332.6 354.6 366 6 343.7 320.7 362.5 320.6 351.4 333 6 332.0 359.2 334 319.0 346.2 333.3 341.1 355.3 353.2 330.2 367.0 324.8 306.7 366.3 326 9 355.5 331.0 333.7 299.2 365.5 379.3 355.8 317.0 319.2 325 0 344.9 364 1 384.6 368.3 389.0 DEAD ANIMAL 4 374.6 401.4 417.4 413.2 366.5 393.1 402.9 377. 359.7 421.5 3S0.2 396.9 374.4 365.7 404.2 360.5 347.9 380.2 389.3 370.6 391.2 388.3 369.7 408.5 360.7 336.0 405.7 364.6 388.7 364.0 359.6 321.0 409.3 417.9 390.3 346.3 356.4 360.2 361.5 398.8 434.6 409.1 430.8 S 401.9 433.2 453.1 443.2 390.0 435.0 A 448.8 370.1 406.1 400.8 394.8 440.4 * 411.5 402.7 393.7 420.3 408.9 396.8 438.8 397.3 361.7 432.6 400.2 429.1 A A 444.6 451.0 375.3 A 390.5 429.6 477.0 439.6 471.9 001950 eOnD . BODY WEIGHTS |G1 TOXICITY STUDY WITH T-5110 HWI 6J29-100 unitey 7 6 9 10 11 12 13 4 44 4 72664461.f4..*Af.t1t1SB 4434 5329 1314 f....t7213 474.ft5 ft 436.5 425.7 416.1 446.7 433.6 416.0 464.1 410.1 362.6 447.3 415.6 457.fAAt4 474.6 477.4 393.ft1 414.ft1 454.3 466.5 492.4 4 44 4 89 2 79 .fA..t190 4 6 6 fff.ttt0 4444 7421 1493 f....t5460 406`.ft2 ft 456.1 442.9 427.4 464.1 446.1 437.9 465.9 425.9 396.6 474.0 439.1 473.fAftt9 496.2 500.6 413.ft6 436.ft6 460.0 465.3 514.0 4 55 60 2046 ff.tt394 5 1 4 fffftttt7 444 364 177 f...t757 527.ft6 ft ft 465.ft6 ft ft ft ft ft ft ft 447.3 499.A3 ft ft 519.ft4 429 ft9 4SS ft9 495.3 ft 543.4 479 A7 555225 .ft73 5 3 7 ffff.tttt4' 444 475 459 .f..t599 546 ft2 fftt 479.ft1 ft ft ft ft ft ft ft 455 4 510.fftt4 ft 553.A3 444 ft1 476.ft1 516 6 ft 566.5 4 55 94 46 16 f.ftt150 5 5 4 ffff.tttt4 444586646 ft511 564.Aft3 ft 494.ft7 ft ft ft ft ft ft ft 478.6 523.fftt8 ft 558 ft4 456 ft2 484 ft5 536 6 ft 570 7 5 0 5 A7 55 95 04 .. 36 ft 5 7 0 ffff.tttt4 444 797051 .f.t466 581.ft7 ft ft 506 ft6 ft ft ft ft ft ft ft 491.8 536.Afftt3 581 ft3 474 ft2 499.ft7 553.3 ft 513 8 5 65 20 0654 ..fftt176 5 1 1 f.fAfttt1 44497163 .3 f..t63 599.A1 ft ft 516.ft0 ft ft fAt ft ft 506 5 552 ft3 ft ft 596 ft9 414.ft2 516.ft4 576 9 ft 603.6 5 56 3 61 9 95 f..f.tt754 5 9 2 f.ffftttt1 554180590 f.t062 602 ft4 ft ft 530 ft4 ft ft ft ft ft ft ft 515 2 562 fAt6 ft 621 ft5 500 ft1 531 ft0 582 9 ft 609 5 ^S6T00 INDIVIDUAL BOOY WEIGHTS (01 13 WK DIETARY TOXICITY STUDY WITH T-5110 ANTHX NUMBER -------------------------------------------------- WEEKS 14 15 16 17 18 19 20 GROUP 3 MALES 10.0000 PPM 67561 67562 67563 67564 67565 67566 67567 67566 07569 67570 67571 87572 67573 67574 67575 67576 67577 67576 67579 67560 67561 67582 67583 67584 67585 67586 67587 67588 67569 67590 67591 67592 67593 67594 67595 67596 1 67597 67596 67599 67600 67601 67602 67603 547.5 A A A A A 616 5 A A A A 525.2 5 0 S .6 A 626 3 A A A 536 $ A A A A A A A 521.2 563.2 A A A 630 7 562.7 A A A A A 631.4 A A A A 527 6 513.4 A 647.1 A A A 542 5 A A A A A A A A 528.9 561.1 A A A 648.0 574.5 A A A A A 614.1 A A A A 531.9 521.1 A 650.2 A A A 558.6 A A A A A A A A 536.3 582.6 A A A 684.3 580.0 A A A A A 622.1 A A A A 537 5 529.2 A 673.5 A A A 570.6 A A A A A A A A 546 2 592 8 A A A 676.5 587.8 A A A A A 612.9 A A A A 525.5 490.3 A 674.8 A A A 568.6 A A A A A A A A 551.4 597.6 A A A 686.6 597.2 A A A A A 636.4 A A A A 532.4 500.6 A 687.8 A A A 574.3 A * A A A A A A 563.3 603.0 A A A 694.3 605.7 A A A A A 637.4 A A A A 539.9 516.0 A 704.6 A A A 583.0 A A A A A A A A 569.0 612.4 A A A 704.0 DEAD ANIMAL 21 613.9 A A A A A A A A A A 544.0 525.2 A A A A A A A A A A A A A 581.5 A A A A A 0cn0 HVI 6329-100 XRimr NUMBER GROUP 7804 7805 67808 67607 67601 67609 67610 67611 67612 67613 67614 67615 01 3 MALES 221 4 201.3 201.1 197.3 194.7 215.3 212 0 193.5 190.9 210.1 205.6 216.0 273.1 264.9 263.2 251.6 252.3 216.2 261.1 246.6 246.5 269.5 270.2 273.3 23 10.0000 PPM 328.0 310.4 316.5 219.0 294.2 331.2 313.2 297.2 291.0 323.7 323.6 317.0 362.2 352.7 350.1 324.7 327.3 314.9 356.2 3 2 S .4 336.4 364.7 362.2 355.9 INDIVIDUAL 800V WEIGHTS (G) 13 WK DIETARY TOXICITY STUDY WITH T-5110 "WEEKS-- 45 6 7I9 396.6 369.3 315.7 355.2 360.1 424.7 313.7 360.0 375.2 403.4 395.9 370.9 421.1 415.5 417.9 311.4 315.9 4SI. 1 411.4 315.5 415.6 431.1 429.0 403.3 440.7 433.9 437.0 397.7 403.3 413.1 429.1 402.7 434.7 480.1 455.6 417.2 451.9 453.1 451.3 425 2 421.5 514 8 445.3 429.2 456 6 414.1 474.5 437.1 480.3 414.1 A 444 9 434 5 537.2 471.5 442.*6 502.*0 449.0 500.2 503.*6 462.3 450.0 558 5 411.6 464.9 A 523.*5 469.5 10 511.1 516.*3 475.5 464.7 582 1 501.4 471.3 A 530.3 A 411.1 11 526.5 530.1 A 413.3 479.4 599.8 512.2 492.2 A 551.1 A 500.4 HUI 6329-100 12 13 540.7 550.4 A 491.5 411.1 617.6 529.7 505.5 A 561.2 A 512.1 555515..13 A 511 2 497.2 619 4 542.1 520 7 A 579 1 A 524 1 o DEAD ANIMAL o CP u \ 0v9l INDIVIDUAL OOOY WEIGHTS (G) 13 WK DIETARY TOXICITY STUDY WITH T-SitO mmz NUMBER GROUP 67604 67605 67606 67607 67608 67609 67610 $7611 67612 67613 67614 67615 ---------------------------------------- weeks------- 14______ 15______ 16______ 17______ 1$______ 1______ 0______ 21 3 MALES * 10.0000 PPM * 632 1 * * * * 635 4 * * * * * * 659 0 669.1 * * * 612.6 * ** * * ** 696.6 * * * 711.2 * a 728.0 AAAAAAA *** ** ** * *** Ittfl 6J?9 100 s 6T00 * DEAD ANIMAL c0o0 INDIVIDUAL 13 WK DIETARY ANIMAI NUMBER 01 GROUP 4 MALES 7616 67617 6761 67619 67620 67621 67622 67623 67624 67625 67626 67627 67621 67629 67630 67631 67632 67633 67634 67635 67636 67637 67631 67639 67640 67641 67642 67643 67644 67645 67646 67647 67641 67649 67650 67651 67652 67653 67654 67655 67656 67657 67651 209 2 114.1 211 5 212.1 222.7 207.7 220.9 193.7 193.3 196.2 207.7 19 0 220.1 219.9 217.2 193.2 207.5 203.4 204.2 166.9 197.1 189.6 193 1 211.7 117.1 113 5 206.5 119.4 215 3 210 6 206 2 115 9 209.1 164.2 205.4 215.7 204 9 201 8 191.7 212.2 195.0 215 1 199.3 261 0 236.0 274 8 269.5 291.8 265.9 271.1 245.3 249 2 251 6 264 5 252 6 290 2 211.1 276 2 246.7 261.1 266.0 266.0 249 1 255 0 231 3 254 S 271.4 247.9 236.1 277 1 237.6 275 4 279.0 264.7 238.6 265.1 236.3 267.6 277.2 259.3 257.6 254.4 267 7 254 5 270.8 255.8 DEAD ANIMAL 23 30.0000 PPM 228.9 277 6 328.6 248.7 335.8 313.4 323.6 293.5 296.3 288.2 253.6 300.0 322.2 337.0 331.3 254 5 301.6 290.9 309.1 296.2 293 1 282.0 303.2 326.7 296.3 279.7 333 4 280.2 320.2 331.8 313 4 281.1 313 8 285.1 322.2 327.7 295.7 318.8 292.1 313 7 305 7 322.4 295.0 357 8 310 5 370.4 351 7 390.3 354 5 366 6 313.7 332.8 327.7 334.6 334 2 386 3 379.1 375.9 324.6 335 5 375 3 349 1 336.2 326.0 314.7 344.9 366.8 335.3 315.2 378.7 309.8 351 0 380 4 353 3 317 4 346.2 321 0 364 3 348.5 327.9 362 2 298.0 351 8 341 2 354.5 328.6 4 393. 339.4 403.6 385.4 429.7 393.1 400 2 340.0 361.6 355.8 366.3 363.9 427.7 407.8 418.2 356.8 364.7 415 4 379.0 367.9 353.3 343.7 375.9 395.0 365.0 364.9 441.0 363.3 407 0 447.3 381 4 346.2 373.0 357 1 397.9 377 2 347.8 401.5 320.3 384 4 376.8 392.7 348.8 5 427.3 362.2 442.3 A 450.9 426.5 427.0 366 1 390.2 377.6 386.8 A 451.6 438.8 451.7 A A 451.2 401.2 404.8 382-0 363.3 404.1 421.3 A 371.1 433.5 355.4 409.1 463 0 414.0 374.6 A 391.3 422.5 403.6 373.4 439.1 A 413.4 388.3 422.7 369.8 CD BODY WEIGHTS (G) TOXICITY STUDY WITH T - 5 U 0 HWI 6379 100 "WEEKS 6 7 8 9 1 0 1 1 12 13 450.9 319.1 466.4 A a 451.0 443.4 315.4 414.4 405.7 470.1 454.1 A A A A 425. 427.3 361.9 430 6 439.6 390.5 455.3 371.0 421.5 493.9 432.0 394.2 415.2 446.7 414.5 394.8 467.9 A 436.7 414 0 440.5 373.4 473.8 404.6 488.2 A A 480.4 454.5 399.4 434.0 425.9 499.1 471.4 A A A A 454 5 451.5 396.8 466.4 461.0 418.8 478.5 387 9 442.6 516.2 457.6 418.7 426 8 467 2 449 5 418 7 489.8 A 459 0 443.3 456.4 391.1 494.4 A 505 4 A A 508 2 478.4 414 3 452.6 442.2 514.7 A A A A A A 479.3 414.0 A A 444.5 A 404.7 A 540.6 A A 446.9 489.3 474 3 440 4 508 3 A A A A 410 4 515.4 A 529.2 A A 524 1 481.2 425 4 468 .0 447 .7 529.8 A A A A A A 495.8 428.9 A A 465.1 A 416.9 A 564 0 A A 466.9 502 9 489 0 453 8 525.7 A A A A 417 9 525.7 A 538 9 A A 540.8 488 5 432.7 475.5 459.9 540.6 A A A A A A 500.0 432.4 A A 479.4 A 422.0 A 565.2 A A 487 7 510 6 500 4 465.6 543.5 A A A A 430.7 549.2 A 561.7 A A 560.7 497.7 446.6 495.9 472.9 563.1 A A A A A A 513 0 446.6 A 493.9 A 434.9 A 589.9 A A 504 1 525 1 515.4 477.4 558.1 A A A A 436.8 555.8 A 574.5 A A 577.2 505.7 455.4 510.1 479.3 571.2 A A A A A A 522 3 452.1 A A 506 8 A 441 .6 A 597.5 A A 519 8 533 0 527 3 488 8 570 3 A A A A 442 9 570.1 A 591.2 A A 596.6 512 1 464 5 518.0 499.9 575 3 A A A A A A 538.5 459 0 A 4 529.1 A 452 7 A 614.6 A A 532.4 550 8 543 9 499 8 577 1 A A A A 451 4 INDIVIDUAL BOOV WEIGHTS (431 13 WK DIETARY TOXICITY STUDY WITH t-5110 6r> ANIMAL NUMBER 14 15 GROUP 67616 67617 67616 67619 67620 67621 67622 67623 67624 67625 67626 67627 67624 67629 67630 67631 67632 67833 67634 67635 67636 67637 67636 67839 67640 67641 67642 67643 67644 67645 67646 67647 67646 67649 67650 67651 67652 67653 67654 67655 67656 67657 67656 4 MALES * A A A * 518 3 a * A 466.6 A 594.4 A A A A A A A A 474.9 A A A A A A A A A A A 539.4 A 544.3 A A A A A A A A A A A A A 517.9 A A A 502.5 A 6012 A A A A A A A A 462.6 A A A A A A A A A A A 543.3 A 558.2 A A A A A A A * DEAD ANIMAL 16 17 30.0000 PPM A A A A A A 526.3 A A A 516.4 A 614.6 A A A A A A A A 494.6 A A A A A A A A A A A 547.4 A 570.5 A A A A A A A A A A A A A 537.6 A A A 520.4 A 630.9 A A A A A A A A 508.4 A A A A A A A A A A A 559.0 A 579.6 A A A A A A A 16 A A A A A A 536.5 A A A 522.9 A 636 8 A A A A A A A A 511.5 A A A A A A A A A A A 556.4 A 582.8 A A A A A A A "WEEKS-- 19 20 A A A A A A 547.2 A A A 539.5 A 646.4 A A A A A A A * 523.4 A A A A A A A A A A A 573.4 A 595.9 A A A A A A A A A A A A A 553.0 A A A 547.1 A 659.9 A A A A A A A A 519.1 A A A A A A A A A A A 560.4 A 602.6 A A A A A A A 21 A A A A A A 559.6 A A A A A A A A A A A A A A A A A A A A A A A 592.3 A 811.3 A A A A A A voo HUI 6329-100 INDIVIDUAL BOOV WEIGHTS (OI 13 WK DIETARY TOXICITY STUDY WITH T-5110 ANIMAI NUMBER ----------------------------------------------------- WFFK5 012345 6 OROUP 4 MALES 3 0 . 0 0 0 0 PPM 87859 67860 67661 67662 67663 67664 6766S 67666 67667 67661 67669 67670 205 9 201 6 1113 20 6 199 1 214 194 6 219 7 201 6 210 7 209.5 203.2 270 1 265.0 245.3 263.3 255.7 269.5 249.1 276.6 259.6 277 6 266.9 263.7 314 1 311 4 214.6 30*.2 306.2 3 0 1 .* 299.0 319.1 311.2 331.5 315.2 320.3 355.6 349.0 317.0 337.4 346.5 354.7 335.7 357.0 360 5 370.5 355.3 362.2 390.9 379.9 344.1 364 7 311.0 392 1 367.5 319.5 396.2 401.1 3(1.3 391. A 409 0 363.1 386.4 A 427.2 A 413.2 426.6 416.9 407.4 416.7 A 424.7 315.6 397.1 A 446.0 A 430.1 449.9 443.1 423.9 443.4 * DEAD ANIMAL 7 A 444. 405.1 413.1 A 473.9 A 450.3 475.0 462.3 439.6 462.3 1 A 466. A A A 504.7 A 471 6 A 472.2 462.3 479.7 9 A 471.0 A A A 524.3 A 419.1 A 416.1 470.5 417.4 10 A 4 1 9 A. 1 A A 543.4 A 496.1 A 500.1 415.5 505.4 11 A 491.7 A A A 556.1 A 510.6 A 514.6 491 5 520.9 HUI 6329-100 12 13 A 499.3 A A A 577.4 A 511.0 A 515.0 509 6 533.1 A 514.0 A A A 590.9 A 531.3 A 50 . 4 517 4 544 4 O 6 CA INDIVIDUAL BOOY WEIGHTS (Gl 13 WK DIETARY TOXICITY STUDY WITH T-51IO wnwt NUMBER -------------------------------------------- wrrre 14 15 16 17 16 19 20 GROUP 4 MALES 30.0000 PPM 67859 67660 67661 67662 67663 67664 67665 67666 67667 67666 67669 67670 A 516.5 A ft ft 607.*1 549.1 A * A 550.1 A 519.4 A A A 621.1 A 546 3 A A A 560.3 A 530.6 A A A 634.6 A 563.4 A A A 571.1 A 526.6 A A A 643.3 A 572.5 A A A 562.4 A 539.6 A A A 650.0 A 575.8 A ft A 591.4 A 545.3 A A A 661.ft2 584.7 A A A 606.3 A 548.0 A A A 876.7 A 590.8 A A A 611.2 * DEAD ANIMAL 21 A 562.0 fAt A ft A 605.6 A A A A HUI 6379-100 S6T00 tNo Oo h* CD en Animal Ntuber __ O 1234 C67671 C67672 C67673 C67674 C67675 C67676 C67677 C67678 C67679 C67680 C67681 C67682 C67683 C67684 C67685 C67686 C67687 C67688 C67689 C67690 C67691 C67692 C67693 C67694 C67695 C67696 C67697 C67698 C67699 C67700 C67701 C67702 C67703 C67704 C67705 C67706 C67707 214.8 219.0 193.4 225.8 198.8 211.5 200.7 189.1 187.2 192.3 195.2 199.2 197.4 206.5 199.0 199.7 206.3 186.4 183.6 212.9 193.6 212.4 208.5 191.5 185.6 216.3 214.8 199.3 188.8 210.4 195.9 208.8 212.8 207.8 191.5 201.8 206.6 246.8 265.6 244.2 279.9 258.5 271.5 254.1 238.7 230.0 242.8 241.4 248.7 250.4 251.4 240.3 258.8 257.9 232.5 243.2 257.3 234.5 264.0 256.1 236.8 226.1 264.4 259.3 245.1 239.1 256.0 238.1 266.3 262.9 255.6 249.5 252.9 258.8 291.9 307.7 287.6 316.1 309.6 318.6 298.6 281.0 273.1 283.7 288.7 290.8 299.5 292.2 274.5 308.2 304.4 272.3 290.3 297.6 261.1 310.2 307.0 273.0 254.5 294.7 293.5 286.3 280.2 296.3 285.8 314.3 296.3 294.9 305.8 296.7 314.0 313.3 348.2 321.0 356.0 349.2 353.2 337.7 320.7 297.3 308.4 310.4 322.4 340.1 326.1 302.1 351.8 332.0 304.5 331.3 328.0 272.9 340.7 346.2 310.3 280.2 314.6 320.8 322.5 321.9 329.1 321.2 353.2 335.6 331.2 350.7 321.3 354.9 349.9 375.6 355.2 385.5 382.9 385.6 371.3 352.8 318.5 341.5 337.8 420.6 369.1 355.4 * 384.7 356.1 322.0 362.0 344.1 291.4 376.9 377.1 337.6 300.9 334.6 342.3 357.0 358.9 361.9 245.6 379.7 372.6 354.5 387.2 345.3 387.6 * Dead animal Indivicfcjal Body Weight Data (g) Week 5 6 7 8 9 10 100 Don T-5180 388.2 407.3 382.3 422.0 * 414.3 403.9 38S.2 336.6 380.8 369.6 * 398.9 380.0 * 420.0 382.2 335.7 313.1 * 367.1 331.6 * 366.0 390.7 395.9 404.0 373.3 411.2 405.2 385.8 422.4 373.9 423.8 410.5 431.8 406.4 442.9 437.3 424.8 408.6 348.8 404.3 420.0 395.6 445.2 352.9 * * 325.8 * * 391.1 344.7 * 389.8 * 421.7 428.0 397.9 433.5 431.3 408.3 447.1 400.2 457.5 429.0 457.1 434.0 467.9 * 457.4 447.5 431.3 372.1 421.7 441.8 413.5 * 462.9 372.5 * * 348.3 * 412.5 360.3 * 403.3 * 438.6 452.3 410.7 454.2 460.0 424.5 475.4 417.1 485.8 453.5 471.8 439.4 492.0 * 472.0 465.9 442.1 384.1 * * * 463.4 422.2 * 475.9 * 383.5 * * 359.4 * 435.9 359.2 * 412.3 * * 475.2 425.7 * 446.6 * 430.4 * 474.7 491.5 452.7 513.2 469.8 486.1 457.9 395.1 # * 483.1 432.8 * 499.4 397.1 373.8 * * 445.8 362.7 * 429.5 * * 486.0 438.8 * 464.2 448.8 * 491.0 499.0 462.9 520.1 442.3 497.2 471.8 406.4 * * 497.2 432.2 * 509.9 * 339.1 * * 358.8 462.8 369.4 441.1 * * 508.7 454.1 * * 478.9 * 463.9 11 507.8 466.8 471.3 535.3 * 448.1 507.1 481.6 419.0 506.7 446.3 527.8 * 371.5 378.8 * 478.4 376.5 456.5 526.4 463.4 * 494.8 * 470.4 * 12 524.1 469.2 485.6 546.2 * 443.1 515.9 493.0 431.4 * * 522.1 450.6 537.9 * 376.8 389.3 * 493.5 376.7 * 467.9 536.1 473.3 507.0 482.4 13 543.1 464.4 496.0 558.1 * 411.3 530.1 501.6 438.6 * 530.6 462.0 * 550.2 * 400.0 402.5 * * 512.8 386.0 * 481.7 554.2 484.0 513.7 * 496.8 HUI 6329-100 Individual Body Weight Data (g) An Inai Number C6767I C67677 C67673 C67674 C6767S C67676 C67677 C67678 C67679 C67680 C6768I C6768? C67683 C67384 C67685 C67686 C67687 C67688 C67689 C67690 C6769I C67697 C67693 C67694 C67B95 C67696 C67697 CG7698 C67699 C67700 C6770I C67707 C67703 C67704 f67705 C67706 C677G7 570* 9 416ft 4 506 3 ft ft ft ft 538 7 463 1 ft ft ft ft ft ft ft ft ft 570 ! ft * * ft ft ft 489 7 ft ft 535ft 9 508 3 -li. ft ft ft 583.3 ft 477ft 4 514ft.9 ft ft 548 6 477.4 ft ft 533 1 ft ft 507 1 ft 546 6 5|7 0 ft ft ft 600.1 ft 476 9 ft 573.3 ft ft ft ft 560 3 486.5 ft ft ft ft ft ft ft ft 596 5 ft 510 7 558 9 57? 3 Week 17 _ U L J3_ _2fi_ JLL ft ft ft 613 4 a 433ft 0 53? 5 ft a a 567 0 498 3 a a a * a a a * 663 8 ft 518 1 56? 9 637 8 100 onm 1-5180 (Continued! ft ft ft 619.7 ft 436 9 ft 533 6 a * * 576 1 503.0 ft a a a a * * 565 9 ft ft a a 577 ? 67? ? 64? ? ft ft ft 636.6 ft 441 .8 ft 540ft.8 ft ft ft 578.9 508.5 ft ft ft ft ft ft ft a 578 1 a * * * * 538ft 5 ft 58? 1 ft 550 9 ft ft ft ft 644.5 ft 369.8 ft 544 8 ft ft ft ft 587.5 509.8 ft ft ft ft ft ft ft ft ft 587.9 ft ft ft ft ft 543 3 ft 591 ? ft 553 1 ft ft ft ft ft ft 397ft 3 ft a a a 503ft ? ft ft ft ft ft a * a a a 594 6 56 ) 3 * Dead an ima 1 HUI 6379 100 Animal Huntoer 0 1234 C62206 C62209 C62210 C62211 C62212 C62213 C62214 C62215 C62216 C62212 C62218 C62219 C62220 C62221 C62222 C62223 C62224 C62225 210.3 189.5 202.2 208.5 218.0 223.2 193.3 212.3 209.2 195.6 220.2 220.6 228.9 215.2 201.0 223.9 208.6 199.2 263.9 236.2 255.4 256.3 266.5 223.9 225.3 260.9 259.6 245.5 221.5 221.9 262.2 258.2 246.5 269.3 262.8 241.6 311.3 264.2 303.9 302.0 314.2 312.8 242.0 301.3 298.1 289.8 316.8 312.6 329.9 298.5 292.9 316.3 298.8 228.2 352.5 290.1 340.2 332.4 354.4 335.1 264.8 326.4 323.2 316.8 354.5 351.6 325.2 334.2 330.2 346.6 335.0 309.1 362.3 308.3 369. 2 465.6 366.0 351.8 280.3 359.2 348.2 343.2 362.1 36t.8 413.8 363.2 359.6 325.1 364.1 332.4 * Dead animai tion Indivickjal Body Uight Data (g) Week 56 7B 100 ccn 1-5160 (Continued) *23.7 333.7 397.1 392.9 *20.6 375.9 298.9 371.6 * *17.6 *13.0 *60.1 391.5 380.1 (02.8 399.5 *5*.* 350.2 *18.2 *12.8 **6.0 315.6 391.3 * **3.0 436.7 *91.3 *15.9 *03.7 21.7 *27.3 * *83.* 365.3 436.1 433.4 *71.9 * 3*4.6 *03.3 * 461.5 *62.0 523.8 434.9 421.3 **1.7 *52.2 * * * *93.9 * 354.3 *18.3 * * 5*5.3 * * 456.3 -* * 9 * * * 511.8 * 369.5 *31.1 * * 575.0 *65.9 * * 10 * * 527.4 382.6 * *39.4 * * 600.5 * * *79.9 * * 11 * * * 539.8 396.5 * 4*8.6 * * 619.9 * *91.8 12 * * * 559.6 *03.9 * *57.3 * 641.7 * * *97.2 * 13 576.6 *17.3 * <69.7 660.3 508.7 HUI 6329-100 Individual Body Weight Data (g) An ima 1 fflbgr C67708 C67709 C677IO C677I1 C67712 Cb7 713 C677I4 C677I4 C677I5 C677I6 C67717 C677I8 C67M9 C67720 C67771 C67777 C677?3 C67774 C67775 __________________________________Week__________________________________ JLJLJLJLJLJLJLJL 100 ppm T-Siao (Continued)* ft * * - SI?. 4 * * * * * * A 520.9 ft ft ft ft ft ft ft ft ft ft $?6 0 * * 540 0 ft ft ft ft ft ft ft ft ft ft ft a * ft 543.7 ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft 547.7 ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft * 557ft 1 ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft 558 ft ft * Dead animal HUI 6379 100 96T00 OOl Animal Humber JL JL _1_ 4 C61126 C61121 C61128 C61129 C61130 C6113I C61132 C61133 C61134 C61135 C61136 C61131 C61138 C61I39 C61140 C6I141 C61142 C61143 C61144 C61145 C61146 C6114I C61148 C6149 C61150 C6151 C61152 C61153 C61154 C61155 C61156 C6151 C61158 C61159 C61160 C61161 202.6 202.2 204.1 226.1 212.8 222.3 226.3 229.1 216.1 211.5 211.2 216.5 220.6 202.3 211.2 218.1 195.6 213.0 205.2 211.5 209.2 215.8 225.6 211.4 216.4 210.9 224.8 223.9 220.1 213.8 195.1 223.2 211.3 218.3 190.4 189.1 249.0 249.9 244.5 251.2 251.8 266.6 261.9 259.1 259.1 252.1 255.6 256.1 261.1 249.2 243.4 261.1 241.3 258.6 252.1 258.9 251.5 263.6 262.1 251.1 261.1 254.2 264.1 264.6 263.3 249.6 242.1 264.4 260.6 258.1 238.6 240 4 283.9 294.8 285.4 290.6 291.1 306.9 291.2 298.6 301.3 294.2 298.5 293.3 303.2 295.0 216.6 298.1 282.1 299.9 291.8 301.4 295.8 303.4 303.9 294.1 298 6 296.8 305.6 302.0 306.1 288.2 286.1 305.1 303.0 299.1 280.9 218.6 323.2 338.4 323.3 326.2 331.3 343.2 333.1 331.1 338.1 326.8 339.5 330.3 345.8 331.8 308.6 339.3 322.5 331.9 331.0 341.5 339.1 342.1 343.5 329.9 334.5 335.8 348.3 343.8 344.2 329.1 330.0 354.1 342.5 344.5 311.0 319.5 354.3 366.4 348.9 365.1 358.1 314.3 365.0 364.8 362.8 356.0 311.9 361.6 380.2 368.4 331.3 311.4 354.6 362.1 363.1 315.8 369.1 310.4 315.4 360.2 365.1 363.2 380.9 313.3 311.0 360.6 360.6 318.9 311.9 314.3 348.1 353.0 Dead animal -voi *tf96T0 HUI 6329-100 Individual Body Weight Data (g) * 378.2 399.8 382.7 403.7 400.8 * 386.3 * 404.9 408.9 408.9 401.8 359.1 * * 392.3 394.1 ft 395.6 408.1 405.0 391.4 393.0 * 417.1 413.1 410.6 386.8 388.4 ft 404.9 ft 373.9 ft _ LWeek __ JL 0 com T-5180 ft ft 397.2 425.9 401.5 420.3 423.4 ft 401.7 ft 422.0 431.0 425.1 425.6 372.8 ft ft 410.9 416.8 ft 409.0 426.4 426.5 407.9 418.7 ft 447.1 437.8 434.3 406.8 408.7 ft 423.1 ft 394.3 ft ft ft 417.4 449.0 421.9 438.6 446.8 ft 412.6 ft 440.8 451.9 440.7 449.3 389.3 ft ft 428.3 433.0 ft 422.9 452.3 442.5 426.3 436.3 ft 469.6 460.0 452.4 414.3 429.1 ft 439.4 ft 413.7 ft ft ft ft ft 435.8 ft 464.1 ft ft ft 458.5 ft 459.8 ft 405.4 ft ft ft 450.3 ft 438.3 472.0 457.5 441.6 ft ft ft ft 473.8 427.4 440.7 ft ft ft 437.5 ft ft ft ft ft 450.0 ft 481.7 ft ft ft 473.5 ft 477.3 ft 427.7 ft ft ft 465.1 ft 446.4 489.1 476.2 460.2 ft ft ft ft 496.0 445.4 456.0 ft ft ft 454.2 ft _1_ ft ft ft ft 451ft.1 490.0 ft ft ft 476.1 ft 488.7 ft 435.4 ft ft ft 469.6 ft 448.2 493.8 479.1 465.8 ft ft ft ft 501.1 452.2 461.7 ft ft ft 463.9 ft JLL ft ft ft ft 466.0 ft 500.3 ft ft ft 493.9 ft 502.3 ft 451.2 ft ft ft 479.3 ft 459.1 508.5 491.1 471.9 ft ft ft ft 514.4 460.6 473.5 ft ft ft 474.0 ft _LL * ft ft ft 477.7 ft 514.2 ft ft ft 504.4 ft 510.7 ft 461.4 ft ft ft 489.2 ft 460.1 523.4 501.1 485.6 ft ft ft ft 526.0 471.8 484.5 ft ft ft 491.0 J3_ ft ft ft ft 491.6 ft 525.8 ft ft ft 514.7 ft 526.2 ft ft ft ft ft 500.7 ft 464.5 534.2 ft ft ft ft ft ft 532.6 ft 492.7 ft ft ft ft ft Animi Number 0 JL ? 3 4 C6776? C67763 C67764 C6776S C67/66 C67767 C67768 C67769 C67770 715. < 777.6 704.0 773.1 198.8 707.3 708.0 774.8 196.4 757.3 769.3 743.0 771.4 744.7 749.7 750.3 758.1 746.8 797.9 313.0 786.7 307.4 786.8 784.7 790.9 301.7 786.3 340.7 358 8 376.4 339 4 376 4 375.1 333 5 346.1 370.3 367.8 391 1 359.7 367.1 357.5 357.7 360.4 377.8 347.3 * Dead animaI e> o CD <o V*,0 00 HUI 6329-100 Individual Body Height Data (g) 56 78 0 Dm* T-5180 (Continued) 421.0 ft 394.2 376.8 394.9 392.5 ft * 444.9 * 413.9 396.0 417.3 413.4 ft ft * 467.4 429.3 3B9.9 433.8 435.0 * ft * * 453.9 * 9 * * * * 466.4 * * * 10 * * * * 472.7 ft * * _LL * * * * * 488.2 ft * ft 12 * * * * ft 492.5 ft ft * 13 ft ft ft ft ft 502.2 ft ft ft INDIVIDUAL FOOD CONSUMPTION IG/WK) 13 WK DIETARY TOXICITY STUDY WITH T-5180 HUI 63?9-100 ANIMAL NUMBER 12 3 4 GROUP 1 MALES CONTROL 67451 67452 67453 67454 67455 67456 67457 67456 67459 67460 67461 67462 67463 67464 67465 67466 67467 67468 67469 67470 67471 67472 67473 67474 67475 67476 67477 67478 67479 67480 67481 67482 67483 67484 67485 67486 67487 67486 67489 67490 67491 67492 67493 172.1 163.4 183.7 176.0 173 9 162 3 171.2 161.3 149.8 162.0 163.8 170.3 170.0 168.8 160.3 179.5 163.4 170.4 174.4 167.9 177.0 181 6 178.3 168.7 180.9 158 1 165.2 162.1 148.3 172.6 157.8 146.5 179.0 166 2 179.4 166.2 165 5 185.7 172.8 1712 157 1 188.4 148.8 185.0 171.1 201.0 198.6 203.2 171.5 179.8 171.4 165.0 181.1 173.9 184.9 172.6 189.9 166.9 187.3 170.6 169 4 185.6 188.9 *A 210.9 197.9 185.1 191.4 175 1 182.8 174.9 166.4 190 6 166.3 155.1 187.7 176 9 196.1 172.1 173.4 197.0 168.4 186.2 163.6 193.2 158.8 198.8 176.4 210 6 218.7 216.5 184.9 179.3 180 5 173.6 188.1 187.5 191.5 175.7 190.5 172.2 186.8 177 1 176.0 192.5 191 3 185.6 216 5 209 1 195 1 200.2 179.9 193.8 184.4 184.2 200.0 175.5 165.5 AA AA 201 0 171 1 179.7 205.7 171.3 194.1 171.2 203 0 159.9 209.5 190 1 217.7 222 6 222.0 187 9 181 4 186 0 178.9 193 4 201 1 196 9 184.7 190 9 178 3 200 3 187.S 180.8 196.3 192.1 AA 214 7 216 8 198.4 213 5 188.8 201.3 193.0 182 1 206.6 179 1 173.1 183.0 201 2 215.1 184 1 179.5 214 2 178.3 AA 182.5 209.5 163.8 * DEAD ANIMAL * INVALID VALUE - FOOD WASTED OR SPILLED 5 213 8 194.6 221.2 225.5 221.4 180.3 A 187.4 186.7 199.6 A 198.6 197.6 190.8 182.3 196.4 191.7 A 204.2 194.2 AA 215.5 199.6 202.1 208.3 195.2 204 0 196.3 171 1 211.2 187 9 179.5 192.7 206.4 224 1 A 189.1 217.6 A 211.4 A A 163.9 WEEKS 67 A 190.9 218.2 AA AA 191.8 A 189 1 184.8 191.1 A 199.6 204.5 A 176.5 192.3 A A 202.2 AA 198,3 216.1 212.7 195.8 207.4 A A 193.8 169 6 202 0 181 7 170.3 189 2 203.0 222.8 A 187.9 216.2 A 198.6 A A 164.8 A 189.5 215.8 AA AA 200.9 A 185 5 179.2 189.5 A 195 5 198.6 A 172.5 186.2 A A 200.4 194.5 206.3 208.2 216.1 199.2 206.8 A A 192.9 162.9 197.2 176.4 172.0 187.6 198.4 219.5 A 183.8 204.6 A 193.6 A A 162.2 8 A 194.1 214.4 AA A 193.6 A A 169.0 179.1 A 198.9 A A A A A A A 193.0 202.0 A 210.0 A 197.2 A A A 142.9 A A 167 9 192.4 A 222.1 A 183 2 198.5 A 167.0 A A 158 7 9 A 193.6 216.9 AA A 193.3 A A 175 7 184.2 A 205.7 A A A A A A A 198.2 198.5 A 219.0 A 206.2 A A A 169.8 A A 172 0 204 1 A 221.9 A 194.1 209.9 A 189.8 A A 164.1 10 A 182 3 209.6 AA A 188.0 A A 171.2 178.3 A 201.1 A A A A A A A 190.6 195.6 A 209.9 A 206.6 A A A 165 6 A A 1710 190.9 A 222 9 A 187 1 199.0 A 186.9 A A 160 1 11 A 190 4 205.5 AA A 188.5 A A 168 9 174 4 A 194.6 A A A A A A A AA 189.0 A 202.3 A 199.8 A A A 121.3 A A 164 2 169 5 A 223 4 A 182 8 194.6 A 178.6 A A 161.8 12 A 175.3 199.7 AA A 182.1 A A 170 7 173.8 A 195.4 A A A A A A A AA 187.0 A 208 6 A 203 8 A A A 110.2 A A 169 5 186.9 A 215 0 A AA 196.8 A 179 9 A A 167.5 13 A 172.7 197.4 AA A 180.6 A A 162.4 162.4 A 190.7 A A A A A A A A A' 181.9 A 199.0 A AA A A A 184 5 A A 1615 181 .9 A 210 6 A AA 186.4 A 175 3 A A 159 6 14 A 180 2 202.8 A A 187 5 A A A A A A A A A A A A A A 179.7 A A A A A A A 161 3 A A A 180 7 A A A A A A AA A A 1516 0019 <<oo S6T00 INDIVIDUAL FOOD CONSUMPTION (G/WKI 13 WK DICTAAY TOXICITY STUDY WITH T-51S0 mwri NUMBER 15 16 17 GROUP 87451 67452 67453 67454 67455 67456 67457 67451 67459 67460 67461 67462 67463 67464 67465 67466 67467 67461 67469 67470 67471 67472 67473 67474 67475 67476 67477 67476 67479 67480 67411 67482 67483 67484 67485 67486 67487 67488 67489 67490 67491 67492 67493 1 MALES CONTROL * 185.2 200.8 A 184.8 A A A A A A A A A A A A A A 188.6 A A A A A A A 187.9 A A A 173.2 A A A A A A 174 7 A A 165.6 A 182.9 192.3 A A 184.2 A A A A A A A A A A A A A A 187.5 A A A A A A A 157.2 A A A 172.0 A A A A A A 177.2 A A 155.0 A 178.0 196.0 A A 185.5 A A A A A A A A A A A A A A 1845 A A A A A A A 180.1 A A A 176.1 A A A A A A 182.6 A A 163.7 DEAD ANIMAL 18 19 A 183.2 203 2 A A ISS 1 A A A A A A A A A A A A A A 197.4 A A A A A A A 181 5 A A A 179 8 A A A A A A 181.2 A A 227.4 A 196.2 207.0 A A 202.3 A A A A A A A A A A A A A A 189.6 A A A A A A A 139.3 A A A 177.6 A A A A A A 190.0 A A 167.1 "TCEK5 20 21 A 185.6 210.1 A A 201.0 A A A A A A A A A A A A A A 194,5 A A A A A A A 143.2 A A A 178.2 A A A A A A 185.1 A A 163.2 A IBS. A A A A A A A A A A A A A A A A A A 203. A A A A A A A 186. A A A A A A A A A A A A A 172. roo\> HVI 63?9 100 ANIMAL NUMBER GROUP 7494 7495 67496 67497 67491 67499 67500 67501 67502 67503 67504 67505 12 3 1 MALES - CONTROL 160 5 197.1 159.0 156.4 174 9 189.9 186 8 153*.*9 177 6 171.4 169.7 163.0 210 2 172 3 171.6 195.7 199.2 176 6 163ft1 191.9 191.9 185.9 166.7 93.7 180 4 178 9 194 8 201.5 177.1 171 0 198.0 192.1 199 8 195.5 4 1710.07 176.9 184.3 199 4 208.7 186.1 1800.03 195.4 203 0 200.0 INDIVIDUAL FOOD CONSUMPTION 10/WK1 13 WK DIETARY TOXICITY STUDY WITH T-5180 "WEEKS-- 5 6 7 8 9 10 1780.08 182.4 191.0 201.5 213.*5 181*.09 0 212.1 203.0 1740.08 00 184.8 201.9 212.04 176.*0 * 210.0 203.6 169.9 206 2 185.1 182 7 205 6 209.05 172.09 0 207.6 196.5 * * 179.1 180.*3 203.09 174.06 0 200.0 192.3 * 0 176 6 179 *6 208 03 175.*4 0 204 7 190.5 0 * 1810 177.*3 204.*3 167.08 0 206.8 193.4 11 0 0 185.3 177.2 194.4 168.01 * 200 4 194.0 12 0 0 176 8 170.*9 194.*7 169.04 0 197.8 198.8 HWI 6329-100 13 14 0 0 00 162.*9 185.*2 166.04 0 194 4 196.0 6 * 00 162 0 0 * * 0 0 0 0 oo * DEAD ANIMAL ** INVALID VALUE - FOOD WASTED OR SPILLED C> to\> <fi ANIMAL NUMBER QROUP 67404 67405 67406 67407 67400 67400 67500 67501 67502 67503 67504 67505 15 16 ____ il_ 1 MALES CONTROL IS 162.7 170.4 157.0 102.3 116050.. 62 101 INDIVIDUAL FOOD CONSUMPTION IQ/WK) 13 WK DIETARY TOXICITY STUDY WITH T-510O "WEEKS 19 20 ___ 2J_ 165.3 100.0 * * 160.0 100.5 102 HUI 6329-100 ,36X00 * DEAD ANIMAL " INVALID VALUE - FOOD WASTEO OR SPILLED ro roo INDIVIDUAL FOOD CONSUMPTION (G/WKI 13 WK DIETARY TOXICITY STUDY WITH T-5180 HUI 6379-100 KNIHT ----------------------------------------------- WEEKS NUMBER 123 45 6 78 9 10 11 12 13 14 OROUP 2 MALES 1.0000 PPM 6750 67507 67501 67509 67510 67511 67512 67513 87514 67515 67516 67517 67518 67519 67520 67521 67522 67523 67524 67525 67526 67527 67528 67529 67530 67531 67S32 67533 67534 67535 67536 67537 67538 67539 67540 67541 67542 67543 67544 67545 67546 67547 67548 159.2 162.6 166.6 185.7 153.8 157.7 158.4 167.0 178.6 179 2 161.0 169 4 165.5 171.0 164.9 158 0 168.7 181.3 163.6 166.5 1S8.8 157.8 156.4 145.7 177.9 172.9 167.7 177.9 167.3 161.5 174.8 14S.2 167.7 162.9 187.9 180.3 141.0 168 2 164.7 163.6 158.2 165.9 156.3 168.1 171.7 176.7 199.8 164.7 163.7 160.3 167.7 187.7 183.4 172.8 179.4 180.3 178.1 182.1 162.6 197.2 192.4 178.8 177.7 168.5 168.2 160.9 163.2 188.8 183.5 181.9 19S.7 180.0 171.8 172.2 152.9 187.3 177 8 208.0 201.2 151.3 190.9 170.9 168.7 160.6 172.1 165.9 176.6 179.7 190.9 209.0 177.5 166.4 173.4 176.7 169.4 194.5 190.9 192.0 AA 193.1 202.7 177.3 216.9 202.5 189 5 191.6 174 2 181.1 167.7 169.8 202.8 194.3 192.7 201.7 191 2 190.5 178 6 163.0 AA 195.6 223 2 AA 165.1 205.7 179.6 175.1 166.0 173.6 172.6 162.1 191.4 195.5 221 0 188.0 175.6 169.3 187.8 195.2 210.1 192 5 191.5 AA 204 6 AA 180.8 219.2 208.9 202.3 205 1 179.1 182 5 180.5 179.3 215 2 210 2 208 3 208 1 193.7 196.2 186 5 169.0 202.0 198.6 230 1 208.7 170.4 213.3 181.7 180.9 173.7 1818 182 3 AA 195.7 192.5 A A A 185.3 195.7 A A 199 2 197.4 AA AA AA 188.5 229.7 212.4 A A 187.9 193.7 AA A A 212 7 211.0 218 5 199.1 202.6 200.3 A 204.2 202.4 237.1 210.7 176.0 219.6 183.0 179.8 182.0 183.1 193.5 AA 193.7 186.7 A A A 182.6 197.8 A A 194.4 193.5 AA AA AA 183.7 228.1 207.6 A A 180.9 191.2 196.6 A A 215.6 203.9 215.3 193.8 195.7 195.0 A 219.9 199.9 224.7 206.0 176.2 189.9 A 178.4 180.1 182.5 183.5 185.7 191.8 179.8 A A A 178.8 196.6 A A 194.9 193.0 AA 202.7 183.2 184.9 230.5 210.9 A A 175.3 186.8 AA A A 218.1 204.6 204.8 104.4 203.3 192.8 A AA 202.9 223.3 206.3 170.7 180.8 A 181.5 174.3 179.7 178.7 A 186.2 176.0 A A A A 184.2 A A 191.4 193.8 AA 199.3 183.9 177.3 A 207.3 A A 181.6 A 173.9 A A A A 203.6 192.6 200.6 187.9 A 196.8 A A 200.9 A 184.6 A A A A 172 9 A 181.4 187.6 A A A A 195.7 A A 194.5 194.9 AA 204.9 192.5 188 6 A 217.7 A A 179.5 A AA A A A A 204.9 192.6 202 9 199 4 A 202 3 A A 217.5 A 180.4 A A A A 182 2 A 185.9 182.0 A A A A 197.6 A A 187.8 183.2 AA 193.4 188.1 188.6 A 204.0 A A 178.2 A 168.3 A A A A 199 2 189 3 186.7 200.2 A 198.4 A A 209.8 A 174.1 A A A A 175 5 A 176.3 180.1 A A A A 200.3 A A 194.7 185.5 AA AA 175.5 186.5 A 211.1 A A 189.6 A 184.3 A A A A 194 1 188.9 184 3 203.5 A 217.1 A A 201.9 A 163.3 A A A A 175 5 A 173.9 173.2 A A A A 200.2 A A 185.1 187.6 AA AA 175.0 184.9 A 199.8 A A 189.4 A 168.4 A A A A 198.1 177.7 201.6 200.2 A 20T .1 A A 202.1 A 149 8 A A A A 171.3 A 168.7 165.7 A A A A 195.0 A A ISO 4 180.2 AA AA AA 180.0 A 199.8 A 168.5 A 164 1 A A A A 197.8 177.8 195 4 197.3 A 198.6 A A 197.8 A 133.6 A A A A 164.7 A A 160.9 A A A A 189.2 A A 182 2 181.5 A A 161.4 A A A A A A A 157 7 A A A A A 174 8 A A A 210.8 A A A A 147.6 A A A A 156 1 * DEAD ANIMAL q ** INVALID VALUE - FOOD WASTED OR SPILLED P fOs) INDIVIDUAL FOCO CONSUMPTION (O/WKI 13 WK DIETARY TOXICITY STUDY WITH 7-51*0 HVI 6329-100 ANIMAT NUMBER 15 16 GROUP 2 MALES 67506 67507 67501 67509 67510 67511 67512 67513 87514 67515 67516 67517 67511 67519 67520 67521 67522 67523 67524 67525 67526 67527 67521 67529 67530 67531 67532 67533 67534 67535 67536 67537 67531 67539 67540 67541 67542 67543 67544 67545 67546 67547 6754 * A 15. 9 A A A A 202.0 A A 195.2 119.6 A A 175. A A A A A A A 157.7 A A A A A 177.4 A A A 207.6 A A A A 150.3 A A A A 172.6 A A 15. 9 A A A A 193 0 A A 194.9 1(8.1 A A 151.2 A A A A A A A 154.0 A A A A A 167.9 A A A 203 1 A A A A 110.6 A A A A 174.5 * DEAD ANIMAL 17 18 1.0000 PPM A A 161.2 A A A A 206.2 A A 190.1 1*7.1 A A 151.2 A A A A A 158.4 A A A A A 169.1 A A A 204.9 A A A A 149.5 A A A A 1(5.2 A A 172.9 A A A A 210.9 A A 201.7 195.6 A A 169.3 A A A A A A A 167.5 A A A A A 1(3.1 A A A 213.4 A A A A 206.5 A A A A 190.4 19 A A 173 7 A A A A 203.6 A A 200.5 203.3 A A 159. A A A A A A A 166.4 A A A A A 172. A A A 216.3 A A A A 17*.6 A A A A 196.7 "WEEKS-----------------------------------------------------------20 21 A A 170.7 A A A A 212.9 A A 194.3 166.6 A A 170.2 A A A A A A 167.1 A A A A A 173.1 A A A 217.5 A A A A 160.4 A A A A 195.1 A A A A A A A 223.4 A A A 174. A A 171.4 A A A A A 164.6 A A A A A A A A A A A A A A A A A 205.7 6T09 ro o ahihaL NUMBER GROUP 67549 67550 67551 67552 67553 67554 67555 67SS6 67557 67559 67559 67560 12 2 MALES 171.1 151.6 177.5 192.1 164.6 191.5 AA 159 5 177.7 171.9 197.4 173.1 179.9 162.9 190.2 200.5 169.1 195.9 197.4 171.9 194.4 191.5 203.9 193.0 34 1.0000 PPM 195.4 177.4 202 7 193 5 191.1 211.2 203.9 175.0 195.2 196.9 215.0 199.4 216.3 179.9 209.7 201*.*5 214.9 210.5 173 3 199.6 193.6 219.6 201.2 INDIVIDUAL FOOD CONSUMPTION IG/WKI 13 WK DIETARY TOXICITY STUDY WITH T-5190 "WEEKS-- 5 6 7 9 9 10 220.9 166.4 209.6 211.3 197.1 215.*6 191.6 206.4 A 225.0 207.3 AA A AA 211*.A 1 215.5 A 175.9 201.1 A A 199.0 229.9 A 203.0 210.2 AA 214.5 A 175.9 199.1 A A 194.1 221 1 A 192 1 214.5 201.4 A A 171.4 A A A A 217.5 A 196.6 218.6 199.4 A A 197.3 A A A A 217.6 A 194.3 210.2 191.3 A A 175.7 A A A A 11 216.4 A 192.3 214.5 195.5 A A 172.9 A A A A 12 221.9 A 192.2 193.6 194.2 A A 177.8 A A A A HVI 63?9-100 13 11 213 1 A 177 9 197 4 164 7 A A 162 4 A A A C0197f) * DEAD ANIMAL ** INVALID VALUE - FOOD WASTED OR SPILLED roion INDIVIDUAL FOOO CONSUMPTION (O/WKI 13 WK DIETARY TOXICITY STUDY WITH T-51IO XHTJWr NUMBER GROUP 67549 67550 67551 67552 6T553 67554 67555 67556 fill 67556 67559 67560 -------------------------------------------- BETKSr 15______ 16______ 17______ U ______ 19 20 21 2 MALES - 1.0000 PPM* HUl 6329-100 C0197 * DEAD ANIMAL NO at T&6T09 INDIVIDUAL FOOD CONSUMPTION (G/WK) 13 WK DIETARY TOXICITY STUDY WITH t-5110 xrmwi NUMBER --------------------------1_______ 2_______ 3_______ 4 GROUP 3 MALES - 10.0000 PPM 67561 67562 67563 67564 67565 67566 67567 67566 67569 67570 67571 67572 67573 67574 67575 67576 67577 67578 67579 67SI0 67511 67512 67SI3 67584 67585 87586 67587 67581 67589 67590 67591 67592 6T593 67594 67595 67596 67597 67598 67599 67600 67601 67602 67603 163.3 175.8 191.6 186 9 183.7 160.3 170.3 169.5 161.7 196.5 152.2 163.7 163.9 148.8 171.6 154.1 158.1 164.4 159.4 162.8 163.9 1S4.2 160.3 166.2 160.0 AA AA 150.5 168.6 158.7 154.6 134.5 170.8 181.0 165.6 157.2 156.6 180.3 162.7 182.9 182 9 173.7 184.7 177.3 188.3 200.1 204.4 188.1 182.9 186.1 177.1 171.0 200.0 171.6 170.4 166.3 163.4 188.6 165.5 154.7 168 7 171 8 166 9 177.5 165.8 168.2 179.7 172*.*9 111 3 163.3 175.9 173.6 167.4 138.2 188.8 197 8 111.1 167.5 158.7 170.6 176.8 196 2 196 1 187.2 282.6 187.0 199.3 208,5 202.1 AA 184.1 193.6 181.6 174.9 200.4 187.5 173.7 170.4 167.1 199.6 170.3 154 1 173.4 185.2 177.1 189.9 184.1 176.6 193.0 AA AA 189.7 170.5 192.7 177.3 177.3 157.0 214.2 202 1 199.8 174 4 174.3 179.3 180.2 196.6 213.2 184 5 122.5 195.6 207.3 213.9 217.5 AA 195 8 191.6 188.4 AA 212.5 174.0 181.1 180.7 174.5 204.9 170.3 156.8 173.7 193.2 179.7 184.3 179 4 192.8 194.7 AA AA AA 171.2 190 8 177 0 188.7 143.7 223.0 201 5 200 7 171.2 A 184 9 189.6 191.9 223.2 201 1 214.8 * DEAD ANIMAL ** INVALID VALUE - FOOD WASTED OR SPILLED roo VI 5 200.4 208.1 214.4 214.0 210.7 A 206.5 A A 216.0 177.1 181.4 190.3 179.0 213.4 A 184.6 200.0 184.7 AA 179.5 195.0 210.4 AA AA 208.2 189.3 191.3 A A 222.1 209.1 178.1 193 1 206.4 232.2 204.3 219.3 "WEEKS---67 1 196.2 A 209.4 216.3 A A 200.3 A A 177.0 177.0 183.2 184.2 A 215.2 A 184.4 200.1 186.5 196.3 173.1 188.5 211.0 AA AA 203.0 180.6 203.7 A A 222.7 209.9 AA 189.7 205.0 A 200.0 208.4 191.7 A 205.6 202.4 A A 209.9 A A 197.7 176.7 180.3 177.7 A 2211 A 179.9 193.3 110.4 200.7 177.4 182.5 213.1 203.2 AA 203.3 177.7 191.2 A A 224.5 209.1 178.1 194.3 212.1 A 194.8 211.7 189.1 A 203.8 200.4 A A 202.7 A A A AA 182.2 171.6 A AA A A 117.8 A A A A A A A A 168.2 182.4 A A 215.6 A 168 8 186.7 199.1 A A 210.6 9 192.8 A 213 9 201.4 A A 217.0 A A A 180 5 187.5 173.9 A AA A A 196.9 A A A A A A A A 154.0 184.5 A A 212.4 A 175.6 194.6 209.4 A A 208.5 10 192 0 A 208 1 205.5 A A 211.4 A A A AA 180.1 169.3 A AA A A 190.0 A A A A A A A A 167 4 178.8 A A 207.6 A 171.8 185.6 208.2 A A 199.1 11 188.5 A 207.0 204.4 A A 198.5 A A A AA 180.4 158.5 A 210.7 A A 183.9 A A A A A A A 171.3 181.0 A A 217.3 A 171.7 118 2 209 2 A A 199 1 12 187.2 A 208.0 192.8 A A 194.0 A A A AA 177.1 159.4 A AA A A 184.5 A A A A A A A A 170.3 176.6 A A 215.4 A AA 184.8 215.6 A A 205.2 HVI 6329-100 13 14 189.0 A 213 9 149.2 A A 193.0 A A A 171 1 177.4 155.1 A 202.0 A A AA , A A A A A A A 160.7 175.4 A A 209.7 A AA 179.5 205.3 A A 186.7 182.3 A A A A A 189.8 A A A A 177 4 160.1 A 203 9 A A AA A A A A A A A A 159 9 166.5 A A 209.2 A A A A A A A INDIVIDUAL FOOD CONSUMPTION (G/WKI 13 WK DIETARY TOXICITY STUDY WITH f-5110 MVI 6379 100 ANIMAL NUMBER WEEKS-----------------------------------------------------------15 16 17 18 19 20 21 GROUP 3 MALES 10.0000 PPM 7561 67562 67563 67564 6T565 67566 67567 87561 67569 7570 67571 67572 67573 67574 67575 67576 67577 67S7S 67579 67510 67511 67512 67513 67514 67515 67516 67SI7 67511 67519 67590 67591 67592 67593 67594 67595 67596 67597 67591 67599 67600 67601 67602 67603 192.5 A ft ft ft A 195.a0 ft 0 0 180.5 172.0 210.*7 * * 111.*4 * Ik * ft ft ft ft 161.2 163.5 ft ft ft 208.5 ft ft ft ft ft ft ft ft ft ft 192.ft1 ft ft ft ft 111.ft2 ft ft ft 170.5 161.ft2 202.ft9 ft ft 112.9 ft ft ft ft a a a 162.3 175.4 ft ft ft 212.1 ft ft ft ft ft ft ft ft ft ft 193.ft9 ft ft ft ft 171.ft0 ft ft ft 174.7 167.ft6 202.ft1 ft ft 113.ft1 ft ft ft ft ft ft ft 163.3 172.1 ft ft ft 207.0 ft ft ft ft ft ft ft ft a 196.ft4 ft ft ft ft 171.ft1 ft ft ft 110.9 116.ft4 214.ft9 ft ft ft ft ft ft ft ft A ft ft ft 179.1 181.6 ft ft ft 216.ft6 ft ft ft ft ft ft ft ft A 195.ft1 ft ft ft ft 116.ft3 ft ft ft 175.7 145.ft3 215.7 ft ft ft 179.ft1 ft ft ft ft ft ft ft 177.7 117.1 ft ft ft 217.2 ft ft ft ft ft ft ft ft ft ft 184.ft5 ft ft ft ft 114.ft2 ft ft ft 171.4 176.ft3 223.0 ft ft ft 111.ft1 ft ft ft ft ft ft 171.0 179.1 ft ft ft 209.ft4 ft ft ft ft ft A ft ft ft 192.5 ft ft ft ft ft ft ft ft ft 186.2 167.ft1 ft ft ft ft ft ft ft ft A ft 177.ft1 ft ft ft ft ft ft ft ft A ft 0 ft ft ft * DEAD ANIMAL ** INVALID VALUE - FOOD WASTED OR SPILLED O P rOo C0 00 ANIMAL NUMBER GROUP 7604 67605 67606 67607 67601 67609 67610 67611 67612 67613 67614 67615 12 3 MALES 175. S 174.9 154 167 1 156.6 203 1 163 6 155.1 149.4 171.2 170.5 171.0 112*A 0 172.1 170 6 170 2 213.1 176.0 173.1 151.4 161.2 114.5 174.2 34 10.0000 PPM 118*.A 3 178.7 179 5 167.1 225 9 190.9 171.7 174.0 205.2 187.9 *81 195.6 193 8 185.6 114.8 176.5 226.2 196.4 181.3 186.0 208.1 191.6 177.9 INDIVIDUAL FOOD CONSUMPTION (Q/WKI 13 WK DIETARY TOXICITY STUDY WITH t-SlIO p e e k s -- 5 6 7 1 9 10 198 4 201.2 192.1 193.5 173.2 223.5 200.8 81 * 192.9 212.6 193.3 176.0 187.7 193.4 182.6 111.6 170.7 225 1 190.9 174.6 116.7 210.5 194.5 174.3 189.7 190.6 183.6 191.0 173.2 218.1 195.0 177.1 189.2 206.9 192.3 179.5 117 9 188.2 189 4 166.6 203 6 192 3 175.*3 202.7 * 172.2 196.3 191.5 * 195.8 170.2 216.8 196.2 180.1 * 208.0 8k 177.1 186.6 119.5 Ik 115.8 174.0 221.5 188.3 179.2 * 209.4 8k 111.8 11 183.6 163.2 8k 1818 168.9 211 4 184.1 174.2 * 201.6 8k 181.2 12 185.4 184.7 * 182.0 183.6 208.6 112.1 176.10 202.1 * 183.9 HWI 6329-100 13 14 115.1 176.6 8k 181.5 161.6 174.9 117.4 174.*1 193.*6 179.6 A A A A A 185 6 A A A A A A C0197i -4fc * > DEAD ANIMAL * INVALID VALUE - FOOD WASTED OR SPILLED NtO)o wrnwr NUMBER GROUP 67604 67605 67606 67607 67606 67609 67610 67611 67612 67613 67614 67615 15______ 16______ 17______ 18 3 MALES - 10.0000 PPM 193 6 161 1 203 2 205 1 INDIVIDUAL FOOO CONSUMPTION (G/WK1 13 WK DIETARY TOXICITY STUDY WITH T-5180 ------------------------ WFTK5~ 19______ 20______ 2J_ 210 9 215 6 217 HVI 6329-100 * DEAD ANIMAL INDIVIDUAL FOOD CONSUMPTION (O/WKl 13 WK DIETARY TOXICITY STUDY WITH T-51IO HVI 6379-100 ANIMAL' NUMBER GROUP ereie 67617 67611 67619 67620 67621 67622 67623 67624 67625 67626 67627 67621 67629 67630 67631 67632 67633 67634 67635 67636 67637 67631 67639 67640 67641 67642 67643 67644 67645 67646 67647 67641 67649 67650 67651 67652 67653 67654 67655 67656 878S7 67659 12 4 MALES 175.4 151.1 172.1 173 4 205.3 171.7 170.7 159.7 159.9 169.9 167.2 155.2 112.2 110.1 111.8 153 1 151.4 161.0 167.5 171.9 156.5 152.6 171.0 174.1 165.7 161.5 113.0 160.5 177.2 182 6 172.6 147.9 169.9 ft ft 177.3 180.0 159 5 163.3 152 2 165.6 171.7 161.6 160.4 111.5 160.7 194.1 177.1 210.5 230.3 117.3 169.0 170ft.ft0 161.7 167.2 231.2 117.5 193.2 161.5 165.0 119.7 259.6 172.6 160.5 160.9 178.5 116.4 110.4 169.6 195.4 157.2 183.3 192.9 181.9 142.1 180.4 172.2 190.9 271 3 163.2 177.6 158.7 171.7 116.7 172 0 242.0 34 30.0000 PPM 193.3 161.6 211.3 114 1 223.6 207.6 190ft.ft4 179.3 115.3 170.4 175.1 202.3 10.1 201.4 166.3 177.6 13.2 194.8 112.7 164.7 170.7 193.9 208.8 119.9 181.6 201.4 ftft 118.3 211 3 191.9 166.0 185.8 ft ft 198.1 119 7 161.6 119.9 21.9 117.6 187.1 189.4 166.1 202.0 182ft.ft7 204 5 230.5 215.6 195ft.ft1 191.1 190.2 174.4 181.8 209.3 190.8 222 0 161.9 171.0 215.7 195.6 116 2 170.0 174.5 207 .5 ft ft 190.8 190 5 194 6 139.5 157.4 202 1 200 4 172 6 190.5 206.5 202.1 204.4 163.4 194 8 151.7 204 0 191.0 201.8 167.0 DEAD ANIMAL INVALID VALUE - FOOD WASTED OR SPILLED fv) 5 205.1 182ft.ft5 ft 246.5 219.0 203.0 191.1 191ft.ft1 ftft ft 211.0 194.7 226.9 ft ft 223.6 202.3 209.6 179.0 183.8 212.7 215.5 ft 222.1 246.1 ft* 229.4 251.3 ftft 174.7 ft 210.4 203.2 206.9 161.7 ft* ft 203 7 174.2 205.3 172.6 T7PFK5-67 9 205.6 111ft.ft5 ft ft 215.1 197.7 112.4 191.ft1 177.ft5 209.3 193.3 ft ft ft ft 200.1 203.7 A 179.6 213.9 216.0 ft 195.2 205.1 159.1 191.3 221.9 ft* 174.6 ft 242.2 206.8 194.3 171.0 ft ft ft 202.2 184.0 201.1 155.4 207.1 184ft.ft8 ft ft 215.6 197.1 184.6 185.ft4 177.ft1 201.5 201.1 ft ft ft ft 202.7 201.ft7 178.9 227.9 ft ft ft 194.4 205.5 159.6 186.6 225.2 201.5 173.3 ft ft ft 207.9 200.1 171.5 207.1 ft 191.4 194.1 196.1 160.6 203.ft0 ftft ft ft 210.7 191ft.ft7 112.ft3 172.ft2 197.ft2 ft ft ft ft ft 197.ft4 181.2 ft ft ft 196.3 ft 153.7 ft 220.7 ft - ft ft 173 1 203.8 191.0 174.9 197.1 ft ft ft ft 163.1 9 204.ft9 ftft ft ft 215 0 119.6 115.2 185.ft1 170.ft6 204.3 ft ft ft ft ft ft 167.2 ft 180.7 ft A ft 203.2 ft 1 5 6f.t2 220.5 ft ft ft 188.6 204 4 204.1 174.5 201.8 ft ft ft A 166.4 10 204.ft4 ftft ft ft 206.3 185ft.ft3 178.ft6 165.ft4 200.0 ft ft ft ft ft ft 116.7 ft ft ft ft ft ft 196.7 A 154.1 ft 190.1 ft ft ft 193.6 203.0 191.9 172.4 202.6 ft ft ft ft 165.1 11 209.ft3 200.ft1 A 209.1 187ft.ft3 115.ft4 174.ft5 200.1 ft ft ft ft ft ft 115.4 ft 110.5 ft ft ft 196.1 ft 154.1 ft 217.3 ft ft ft 190.1 201.3 194.4 170.2 191.0 ft ft ft ft 164 6 12 209.ft9 206.ft0 ft 209.4 112ft.ft0 184.ft9 161.ft1 191.5 ft ft ft ft ft ft 110.2 ft 1 7 3A. 9 ft ft 195.4 ft 1 55f.t7 207.1 ft ft ft 119.6 203 2 184 4 171 2 201.7 ft ft ft ft 158.1 13 204.ft6 ftft ft ft 197.1 176ft.ft2 173.ft2 186.A1 115.ft5 ft ft ft ft ft 181.1 1 7 5A. 4 A ft 117.2 ft 1 4 9A. 6 194.3 ft ft ft 110 1 1914 184.1 1713 192.0 ft ft ft ft 152.7 14 ft ft ft ft ft ft 163.A3 ft A 159.ft9 177.A4 ft ft ft ft ft ft ft ft ft A ft ft ft ft ft ft ft ft ft ft 175 1 ft 1 7 7f.t0 A ft ft ft A ft INDIVIDUAL FOOD CONSUMPTION (Q, 13 WK OIETARY TOXICITY STUDY Wl -5110 HUI 6379-100 ANIMKE NUMBER 15 16 17 16 GROUP <7616 67617 67611 67619 67620 <7621 67622 67623 67624 67625 67626 67627 67626 67629 67630 67631 67632 67633 67634 67635 67636 67637 67636 67639 67640 67641 67642 67643 87644 67645 67646 67647 67646 67649 67650 67651 67652 67653 87654 67655 676S6 67657 67656 4 MALES ft ft ft ft ft ft 165.ft1 ft ft 169.ft6 176.ft5 ft ft ft ft ft ft ft 177.ft4 ft ft ft ft ft ft ft ft ft ft 166.ft2 166.ft2 II ft ft ft ft ft ft ft ft ft ft ft 160.ft2 ft ft 170.ft3 165.ft4 ft ft ft ft ft ft ft ftft ft ft ft ft ft ft ft fftt ft ft 175.ft6 169.ft3 ft ft ft ft A ft 30.0000 PPM ft ft ft ft ft ft 172.ft0 ft ft 171.ft1 166.ft0 ft ft ft ft ft ft ft ftft ft ft II ft ft ft ft ft ft ft II ft ft ft ft 162.ft2 ft ft 179.ft1 191.ft4 ft ft ft II ft ft ft ftft ft ft ft ft ft ft ft ft ft ft ft 192.ft9 190.ft0 ft ft ft ft ft ft ft ft 177.ft9 194.ft3 ft ft A ft ft ft * DEAD ANIMAL * INVALID VALUE - FOOO WASTED OR SPILLED 19 ft ft ft ft ft ft 165.ft9 ft ft 190.ft0 190.ft7 ft ft ft ft ft II ft ftft ft ft ft ft ft ft ft ft ft ft ft 196.ft2 191.ft5 ft ft ft ft ft ft wrors-----------------------------------------------------------20 21 ft ft II ft ft ft 160.ft3 II ft 164.ft1 167.ft0 ft ft ft ft ft ft ft ft** ft ft ft ft ft ft ft ft ft ft ft 196.ft6 166.ft4 ft ft ft ft ft ft ft ft ft ft A ft 163.ft7 II ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft ft 206.ft4 191.ft2 ft ft ft A ft A ANITW NUMBER 1 2 ____ 3____ 4 GROUP 4 MALES 30.0000 PPM #785# 67660 67661 67662 67663 67664 67865 67666 67687 67661 67669 67670 177. 166.6 151 5 172 1 165.9 173.1 152 8 110.5 165.7 112.0 189.2 187.3 110.1 175.9 151.5 171.1 175.5 173.3 167.0 1(1.2 179 8 196.7 17. ( 111.4 191.5 114.1 163.6 112.2 171.2 1(4.6 173.9 1(6.5 1(7.7 199.6 175.0 199.2 201 0 1(9.5 165. 1(7 2 193.6 192.7 179.5 192.4 195.3 205. 194.0 193.1 * > DEAD ANIMAL INDIVIDUAL FOOD CONSUMPTION (Q/WK) 13 WK DIETARY TOXICITY STUDY WITH T - 5 H 0 -v m s-- 5 6 7 9 10 * 192.6 167.7 1(7.*0 200.2 A 19.7 196.9 211.8 205.3 200.3 A 1(6.4 162.7 1(0.4 A 192.9 A 189.7 195. 174.5 193.7 201.3 A 1(3.5 185.0 178.0 A 191.4 A 192.6 196.7 1(2.6 1(7.2 202.2 A 1(1.9 A A A 195. A 184.7 A 179.3 117.0 190.3 A 1(7.5 A A A 196.5 A 196.3 A 174.1 195.2 196.7 A 179. A A A 194.0 A 1(5.6 A 176 9 1(9.1 192.9 11 A 173 5 A A A 194.2 A 1(2.7 A 176.7 194.6 181. 12 A 172.5 A A A 192. A 115 A 153.0 186.7 190.6 HWI 6379-100 13 14 A 174.1 A A A 190.2 A 1(4.6 A 130.1 1(1.1 1(5. A 167.9 A A A 195.6 A 177.9 A A 177.6 b i *6T00 INDIVIDUAL FOOD CONSUMPTION (O/WKI 13 WK DIETARY TOXICITY STUDY WITH T-5180 XHTOXt NUMBER 15 16 ___ 17__ 18 OROUP 87659 67660 67661 67662 87663 67664 67665 67666 67687 67668 67669 67670 4 MALES 161.*3 * A 193.1 171 *0 A a 186.5 A 171.0 A A A 197.9 A 189.6 A A A 191.1 30.0000 PPM A 171.8 A A A 191.5 A 190.5 A A A 168.8 A 183.6 A A A 199.9 A 194.5 A A A 199.3 DEAD ANIMAL WEEKS 19 20 21 A 181.1 A A A 206.1 A 204.9 A A A. 198.4 A 171.6 A A A 204.5 A 197.5 A A A 192 1 A 179.4 A A A A A 203.4 A A A HWI 6329-100 ---------------- Animal Wimtoer 1 45 C67671 C67672 C67673 C67674 C67675 C67676 C67677 C67678 C67679 C67680 C67681 C67682 C67683 C67684 C676B5 C67686 C67687 C67688 C67689 C67690 C67691 C67692 C67693 C67694 C6769S C67696 C67697 C67698 C67699 C67700 C67701 CA7702 C67703 C677M C67705 C67706 C67707 1J8.9 H 8 .2 H I.5 163.9 159.5 168.0 U 8 .3 H A .4 150.2 139.5 155.6 H 6 .2 153.5 153.2 H 6 .1 160.5 154.6 141.0 152.7 155.0 147.4 167.5 154.3 155.5 138.7 154.1 160.6 145.8 161.8 163.0 151.3 170.0 168.4 159.5 156.4 141.4 167.4 153.8 158.8 156.4 169.5 183.4 180.9 161.3 154.4 163.2 149.8 175.9 162.7 164.9 166.8 150.2 168.6 171.4 154.8 163.5 161.2 143.7 176.8 166.9 162.5 141.2 157.4 167.1 153.9 171.3 167.7 161.9 175.8 175.0 170.5 174.6 154.2 180.2 164.1 174.3 166.7 190.1 193.2 198.4 177.2 168.0 170.8 158.0 182.4 175.8 173.5 179.9 153.3 188.9 172.6 178.1 179.2 176.0 137.4 186.7 184.3 181.1 155.0 166.9 180.2 170.2 186.5 187.3 169.9 183.1 193.4 200.7 196.0 157.9 197.6 172.6 178.4 181.1 199.7 200.1 208.4 180.1 176.6 179.8 169.9 180.4 186.7 181.7 183.5 190.4 179.2 177.0 187.9 175.0 155.6 197.1 193.5 181.0 157.8 170.1 182.8 184.5 205.0 195.5 174.5 186.1 207.0 194.0 202.8 164.8 205.4 198.3 186.7 192.5 206.0 207.6 213.7 189.3 182.5 178.8 185.2 183.0 180.9 189.0 * 199.2 184.9 174.8 159.9 207.7 195.2 193.8 167.7 171.8 191.9 195.6 219.2 209.0 183.6 191.5 221.1 204.2 209.3 176.8 202.4 * Dead animal ** * Invalid value - food wasted or spilled. CQ19S) (NJ t-- Individual Food Consumption Oats (g) ______ Wek__________ _L -S_ JL 100 oaa 1-5180 10 189.3 IBS. 188. 201. * 211.0 188.7 182.2 173.7 179.6 * 175.9 183. * 19.6 * 18*2.2 * 155.5 * 186.8 162.8 * 189.6 * 215.1 20.9 182.9 190.0 236.3 198.2 20.2 176.3 213.3 192.8 18.5 197.3 198.2 207.5 186.2 177.5 178.7 179.5 * 180.0 181.8 * 186.7 * 177.9 * 159.3 * * 189.1 156.0 186.5 * 196.8 201.6 173.1 188.2 215.3 190.7 206.5 170.2 210.8 188.2 17.1 180.2 200. * 190.2 182.7 181.5 205.0 187.8 18.3 170.9 172.3 186.8 191.7 172. 183.5 * ** 176.8 178. 177.9 169.9 18*2.9 189.1 * 169.1 ` 182.3 * ** 159.2 * * 165. * * 188.3 1*8.7 189.9 1*7.0 179.8 * 189. 198.4 168.5 157.5 185.3 195.0 172.0 162.5 1*9.6 188. A 206.8 178.0 * * 207.5 * 171.5 A 193. 177.5 177.2 169.3 * 123.2 179.6 168.7 176.3 * 173.8 ft* 18S .6 128.5 * ft 137.7 187.1 148.7 184.9 * 199. 176.9 * * 205.2 * 173.0 ft 11 190.1 126.0 176.9 194.3 138.2 174.8 165.9 173.1 * ft ft 167.2 1 5f9t. 6 1 8f1t. 9 134. ft ft 142.1 ft ft 162.8 146.4 ft 190.7 ft ft 198.7 176.7 ft ft 2 0 f3t. 7 164.9 ft 12 200.1 1* 4 .7 185.2 1 9f5t. 8 142.0 176.3 165.2 1 7f8t . 8 ft ft 174.2 16f2t.1 18f5t.3 1 5f6t. 4 ft 150.9 ft ft 186.0 147.9 ft 188.5 ft ft 203.8 179.2 ft ft 198.5 ft 166.1 ft 13 192.8 127.9 176.1 1 9f0t.9 114.8 173.7 155.6 1 7f0t. 5 ft ft 164.8 1 5f5t. 4 1 8f4t. 5 153.3 ft ft 151.2 ft ft 184.5 142.0 ft 183.2 ft ft 197.6 170.6 ft ft 187.4 ft 1 6f7t . 8 HUI 6129- tOQ Animal Humber C67671 C6767? C67673 C67674 C6767S C67676 C67677 C67678 C67679 C67680 C6768I C676B2 C67683 C67684 C6768S C67686 C67687 C67688 C67689 C67690 C67691 C6769? C67693 C67694 C67695 C67696 C67697 C67698 C67699 C67700 CS770I C6770? C67703 C67704 C67705 C67706 C67707 Individu! Food Consumption Oata (g) JL. ft * 180.8 114.6 * 153.5 ft ft ft ft 165.2 161.8 ft ft ft ft ft ft ft ft ft 174.? ft ft ft ft ft ft 169.9 ft ft 203.7 ft 164.5 ft -li- ft ft ft 192.7 ft 140.6 ft 159.2 ft ft ft ft 174.2 182.5 ft ft ft ft ft ft. ft ft ft 185.6 ft ft ft ft ft ft 182.4 ft ft 212.2 ft 177.5 ft _______ Meek______ _1L. J I. _LS_ J L . _2fi_ _2L 100 Dom -5180 (Continued) ft ft ft 192.7 ft 132.2 ft 158.7 ft ft ft ft 167.5 177.6 ft ft ft ft ft ft ft ft 187.2 ft ft ft ft ft ft 175.7 ft ft 217.0 ft 171.9 ft ft ft ft 196.1 ft 140.4 ft 157.5 ft ft ft ft 162.6 171.0 ft ft ft ft ft ft ft ft ft 189.3 ft ft ft ft ft ft 170.8 ft ft 201.1 ft 167.5 ft ft ft ft 204.1 ft 144.1 ft 164.5 ft ft ft ft 174.0 178.4 ft ft ft ft ft ft ft ft ft 189.5 ft ft ft ft ft ft 183.1 ft ft 198.9 ft 172.5 ft ft ft ft 201.1 ft 154.3 ft 157.2 ft ft ft ft 173.9 173.4 ft ft ft ft ft ft ft ft 195.1 ft ft ft ft ft ft 182.4 ft 196.7 ft 167.8 ft ft ft ft 195.5 ft 53.3 ft 154.6 ft ft ft ft 164.7 165.4 ft ft ft ft ft ft ft ft 193.9 ft ft ft ft ft ft 177.1 ft 200.1 168.8 ft ft ft 196.4 ft 165.5 ft 159.5 ft ft ft ft 171.6 146.6 ft ft ft ft ft ft ft ft 193.5 ft ft ft ft ft ft 173.9 ft ft 192.9 ft 171.4 ft "S 6 T 0 0 *"*1 Huifcer C67708 C67709 C67710 C67711 C67712 C6771J C677H C67715 C67716 C677I7 C67716 C67719 C67720 C67721 C67722 C67723 C67724 C67725 Individui Food Consumption Oats (g) ___________________________________ Weak _L 2 _L 4 5 JL 8 9 165.6 1*2.6 160.7 157.5 159.0 169.9 138.7 15*. 7 159.* 152.4 164.0 161.3 182.5 154.2 1*9.4 163.0 158.4 1*9.2 175.4 155.6 179.7 176.2 169.8 180.9 135.5 163.7 161.9 162.7 176.5 164.7 195.5 148.0 161.0 173.4 163.9 166.0 196.6 175.8 203.1 178.1 198.5 192.6 1*0.7 177.1 165.4 164.8 193.6 180.0 224.0 171.9 176.3 186.4 191.7 189.0 201.2 170.8 200.4 181.0 197.6 193.4 134.9 193.1 169.6 176.5 199.1 181.8 235.4 171.2 184.0 186.3 197.6 188.9 210.9 181.9 206.5 185.9 183.8 199.9 153.4 200.9 176.1 205.2 194.9 257.0 187.4 176.1 194.3 211.3 100 Dos T-5180 (Continued) 214.5 177.6 205.6 181.9 210.2 ft 153.4 ft 167.7 ft 204.0 191.1 244.2 179.3 180.9 188.0 208.9 ft 220.1 168.2 196.7 178.2 206.5 ft 154.7 ft 164.2 ft 197.0 189.3 238.1 170.6 180.0 183.0 208.0 ft 190.6 118.7 193.4 179.2 207.1 ft ft ft ft ft 215.7 ft 155.5 158.3 ft ft 160.8 168.0 ft ft 201.6 136.1 ft ft 242.0 145.1 129.6 242.9 ft ft 176.6 177.1 175.9 ft ft ? ft 10 ft ft ft ft 212.5 ft 160.1 ft 162.1 ft ft ft 243.4 ft ft 172.1 ft ft 11 ft ft ft ft 205.5 ft 159.0 ft 138.4 ft ft ft 244.8 ft ft 173.8 ft ft 12 ft ft ft ft 213.2 ft 158.6 ft 160.7 ft ft ft 240.6 ft ft 170.3 ft ft 13 ft ft ft ft 218.5 ft 157.0 ft 162.0 ft ft ft 236.2 ft ft 174.3 ft ft * Ocad animal ** In valid value - food wasted or s p ille d . HUt 6329-100 A n im i H *fae r C67708 C67709 C67710 C47711 CA7712 C67713 C677H C67715 C67716 C67717 C67718 C67719 C67720 C67721 C67722 C67723 C67724 C67725 Indlvlffcjal Food Consuiption Data <g) _____________________________________ Utek_________________________________________ _ H _ 1S _ 16 17 18 1 20 21 100 oca 1-5180 (Contlnutdl . . . . . . . . . . . 139.9 * . * . . . . . . . . . . . 181.J * . * * * . . . . . . . . . . . 179.2 . * * . . . . . . . . . . 170.1 * . * * . ... ... * ... ... ... ... ... ..* ... ... 179.2 173.7 * ... . . . . . . . . * . . 171.5 *. . ITT .4 * * > Dead anim i ** > In v alid value food wasted or s p ille d . HUI 6329-100 S6T03 ro 00 Animal Batte -2- J L 4 C67726 C67727 C67728 C67729 C67730 C6773I C67732 C67733 C67734 C67735 C67736 C67737 C67738 C67739 C67740 C6774I C67742 C67743 C67744 C67745 C67746 C67747 C67748 C67749 C67750 C677SI C677S2 C67753 C677S4 C67755 C67756 C67757 C677S8 C67759 C67760 IS3.0 154.9 154.6 154.9 154.1 154.9 154.9 152.6 153.0 154.7 152.9 154.3 153.0 153.9 154.9 154.9 153.4 151.9 154.9 154.9 154.9 154.9 154.9 154.9 154.9 154.9 154.9 154.9 154.9 154.9 150.4 154.9 154.9 154.9 152.9 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 I6S.0 165.0 165 0 165.0 165.0 165.0 162.8 165.0 165.0 165.0 160.8 179.3 179.3 179.3 179.3 178.3 179.3 179.3 179.3 179.3 179.3 179.3 179.3 179.3 179.3 179.3 179.3 179.3 178.6 179.3 179.3 179.3 179.3 179.3 179.3 179.3 179.0 179.3 179.3 179.3 179.3 176.7 179.3 179.3 179.3 166.0 184.6 184.9 184.9 184.9 182.6 184.5 184.9 184.4 180.0 184.9 184.7 184.9 184.9 184.9 184.9 184.9 184.9 170.9 184.9 184.9 184.9 184.9 184.9 184.7 184.9 184.4 184.9 184.5 184.9 175.3 181.2 184.9 184.9 184.9 176.0 * * 193.7 193.7 190.5 193.7 193.7 182.2 193.7 193.7 179.6 1937 154.4 * 180.0 186.8 193.7 193.7 193 7 193.0 193*.7 193.7 1930 193.5 166.4 183*.4 19*3.7 179.9 Dead animal. 1 Spilled feed. ro KO jS6T00 Individu*1 Food Consumption Osta (9) JL Meek A. JL * 190.8 ft* ft 190.8 190.8 ft 174.2 ft 190.8 187.1 163.7 190.8 IS O . 1 ft ft 175.9 175.6 190.8 190.8 190.8 190.8 172.6 ft 190.8 190.0 ft* 167.8 1 7f6t. 0 190.8 ft ft 0 DO* ft ft 188.6 188.6 185.2 188.6 188.6 ft 166.2 ft 188.6 177.6 158.0 188.6 1 5f5t. 9 ft 168.9 181.0 ft 1886 188.0 188.6 187.6 163.7 ft 188.6 187.3 184.9 1530 175.1 ft 187.5 ft 170.6 ft ft ft ft 182.5 ft 184.3 ft ft ft 182.5 ft 164.0 ft 16f4t. 0 ft ft 178.4 ft 184.2 183.8 183.6 183.8 ft ft ft ft 182.4 156.9 170.3 ft ft ft 173.7 ft ft ft ft 184.8 ft 185.1 ft ft ft 185.1 ft 165.9 ft 1 7f7t. 3 ft ft 181.6 ft 185.1 183.6 185.1 184.0 ft ft ft ft 185.1 155 7 176.3 ft ft ft 180.0 JO . ft ft ft ft 175.8 ft 175.9 ft ft ft 176.1 ft 160.3 ft 1 6f6t. 3 ft ft 171.9 ft 175.9 174.9 176.1 175.8 ft ft ft ft 176.1 159 3 167.8 ft ft ft 171.8 JLL ft ft ft ft 172.1 ft 173.1 ft ft ft 172.9 ft 168.9 ft 172.4 ft ft ft 173.4 ft 173.0 173.4 173.4 172.5 ft ft ft ft 173.4 160.1 165.9 ft ft ft 160.7 JL. ft ft ft ft 175.1 ft 177.0 ft ft ft 177.1 ft 158.0 ft 167.3 ft ft ft 175.2 ft 177.0 174.9 177.2 177.1 ft ft ft ft 177.2 155.8 164.3 ft ft ft 176.2 J 3L ft ft ft ft ft* ft 171.3 ft ft ft 171.7 ft 157.5 ft ft ft ft ft 168.1 ft 171.2 163.4 ft ft ft ft ft ft 17f1t.7 159.5 ft ft ft ft HUI 6329-100 Individual food Consumption Oata (g) Animal JhmfaSr C6776I C67762 C67763 C67764 C6776S C67766 C67767 C67768 C67769 C67770 _L 148.8 154.9 154.9 143.9 154.9 154.9 149.2 154.9 154.9 153.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 165.0 164.9 163.3 JL 179.3 179.3 179.3 179.3 154.7 179.3 179.3 179.3 179.3 166.8 4 184.9 184.9 184.7 184.9 169.5 180.0 184.9 184.9 184.9 169.6 _5_ 193 1 179.5 183.9 192.9 193*.7 * wsL _S_ _L -fi_ 9 0 ppm T-5180 (Continued) * ft ft ft ft ft * 190*.8 18f8t.S ** ft ft 164.7 188.5 153.6 ft ft 184.9 190ft.8 179.3 182ft.5 178.1 *ft 17*7.9 ft ft * ft * _UL ft ft ft ft ft ft 17f0t.2 ft ft JJL ft ft * ft ft ft 167ft.7 ft ft _LL ft ft ft ft ft ft 16f3t.2 ft ft J 3_ ft ft ft ft ft ft 161ft.9 ft ft * * Dead anima). ** - Spilled feed. HUI 6329-100 J[&6T00 frOsoj HWI 6329-100 APPENDIX C Individual Clinical Chemistry Values 221 C019s 6 &o p ( rNr\o> 0 ANIMAL NUMBER INDIVIDUAL CLINICAL CHEMISTRV DATA HALES WEEK S PCOAO IU/Q GROUP: 1 C67461 C6746I C674S6 C67491 C67500 MEAN S.D. N GROUP: 2 C87524 C67S25 C67530 C675S5 C675SI MEAN S.D. N GROUP: 3 C67576 C67S77 C67S91 C67S9S C67599 MEAN S.D. N DOSE LEVEL: 0 9I 9 t 9 I .5 S DOSE LEVEL: 1 I 9 8 10 12 9 1.7 5 DOSE LEVEL: 10 11 16 10 17 II 14 3.6 5 DOSAGE UNIT: PPM DOSAGE UNIT: PPM DOSAGE UNIT: PPM HWI 6329100 ANIMAL NUMBER INDIVIDUAL CLINICAL CHEMISTRY DATA MALES WEEK S PCOAO IU/Q OROUP: 4 C87027 CS7631 CS7632 C67663 C8766S MEAN S.D. N OROUP: S C87882 C878I9 C878B0 C87717 C8772S MEAN S.D. N OROUP: 8 C87728 C87733 C67741 C87745 C67782 MEAN S.D. N DOSE LEVEL 18 21 43 IS 27 24 11.4 S DOSE LEVEL S8 21 41 43 It 37 14.6 5 DOSE LEVEL 8 1 I 1 t 8 .4 5 100 DOSAOE UNIT: PPM DOSAOE UNIT: PPM DOSAOE UNIT: PPM HWI 6329100 S6T0.0 no nCoO oo p rrvo) ANIMAL NUMBER INDIVIDUAL CLINICAL CHEMISTRY DATA MALES WEEK I PCOAO IU/G GROUP: 1 C674S3 C6T4I0 ce riti cern i eenes MEAN S.D. N GROUP: 2 CC7S22 C67S31 CI7532 c irs io cerseo MEAN S.D. N GROUP: 3 cersri CI75I3 ce rsii ce rsir CI7812 MEAN S.D. N DOSE LEVEL e s 7 e r r IS s DOSE LEVEL 7 7 e e 7 .1 S DOSE LEVEL 10 ie 25 14 IS 16 5.5 5 10 DOSAOE UNIT: PPM DOSAGE UNIT: PPM DOSAGE UNIT: PPM HWI 6321100 ANIMAL NUMBER INDIVIDUAL CLINICAL CHEMISTRY DATA MALES WEEK I PCOAO IU/G GROUP: 4 C87034 C97942 CB7944 C07057 C07SB1 MEAN S.D. N GROUP: S CB79I0 C67707 C67709 C67719 C87722 MEAN S.D. N GROUP: C07731 C07734 C07737 C07700 C67789 MEAN S.D. N DOSE LEVEL: 30 35 32 30 49 15 32 12.2 5 DOSE LEVEL: 100 55 9 107 40 53 54 35.3 5 DOSE LEVEL: 0 < 7 9 7 5 7 1.5 5 DOSAGE UNIT: PPM DOSAGE UNIT: PPM DOSAGE UNIT: PPM HWI 329100 C01990 ruNoi ANIMAL NUMBER INDIVIDUAL CLINICAL CHEMISTRY DATA MALES WEEK 14 PCOAO IU/Q GROUP: 1 C$7460 C$7462 C67473 C674I7 C67501 MEAN S.D. N GROUP: 2 C87S28 C87533 C67S40 C67SS1 C675S3 MEAN S.D. N GROUP: 3 C67S64 C6760I C$7610 C$7611 C67615 MEAN S.D. N DOSE LEVEL: 0 6 7 S 7 7 $ .6 5 DOSE LEVEL: 1 11 7 6 7 I t 1$ S DOSE LEVEL: 10 t 13 $ 10 s 10 2.1 5 DOSAGE UNIT: PPM DOSAGE UNIT: PPM DOSAGE UNIT. PPM HWI $328100 66T00 orItMo ANIMAL NUMBER INDIVIDUAL CLINICAL CHEMISTRY DATA HALES WEEK 14 PCOAO IU/Q GROUP: 4 C67616 C6T623 C67643 C676S2 C67653 MEAN S.D. N GROUP: S C67671 C67672 C676B1 C67700 C67714 MEAN S.D. N GROUP: 6 C67730 C6773I C67746 C67754 C87767 MEAN S.D. N DOSE LEVEL: 30 11 15 16 10 II 14 3.4 5 DOSE LEVEL: 100 16 14 23 17 ...4.5 5 DOSE LEVEL: 0 7 6 5 5 4 51 1 S DOSAGE UNIT: PPM DOSAGE UNIT. PPM DOSAGE UNIT: PPM HWI 6329100 1?66T03 iNvj ANIMAL NUMBER INDIVIDUAL CLINICAL CHEMISTRY DATA MALES WEEK 22 PCOAO IU/G GROUP: 1 C874S3 C674S6 C674I3 C674B0 C67486 MEAN SO. N GROUP: 2 C67S0I C87518 C87S34 C87538 C67543 MEAN S.D. N GROUP: 3 C67567 C67575 C67579 C875I9 C67S93 MEAN S.D. N DOSE LEVEL 8 7 7 7 8 7 .7 S DOSE LEVEL 7 7 10 6 8 7 1.6 5 DOSE LEVEL 8 7 7 7 S 7 1.1 5 10 DOSAGE UNIT: PPM DOSAGE UNIT: PPM DOSAGE UNIT: PPM HWI 6329100 C0199* NrC Do e o tj) ff\OJ ANIMAL NUMBER INDIVIDUAL CLINICAL CHEMISTRY DATA MALES WEEK 22 PCOAO IU/Q GROUP: 4 C67828 C6762I C67837 C67664 C67870 MEAN S.D. N GROUP: 5 C87874 C6767I C878I3 C67694 C67701 MEAN SO. N DOSE LEVEL 6 7 8 7 7 11 S DOSE LEVEL 7 6 7 7 7 7 .4 S 100 DOSAGE UNIT: PPM DOSAGE UNIT: PPM HWI 6329100