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FINAL REPORT CMA # VDC 1.3 September 8, 1982 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS By M. J, McKenna, J. F. Quast, H. 0. Yakel, M. F. Balmer and L. W. Rampy Sponsored by Chemical Manufacturers Association Vinylidene Chloride Program Panel Toxicology Research Laboratory Health and Environmental Sciences USA Dow Chemical USA 1803 Building Midland, Michigan 48640 SL 082285 TABLE OF CONTENTS SUMMARY INTRODUCTION MATERIALS AND METHODS RESULTS AND DISCUSSION SUMMARY AND CONCLUSIONS SIGNATURE PAGE REFERENCES QUALITY ASSURANCE STATEMENT FIGURES TABLES 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. Tissue Samples Obtained and Preserved from All Animals at Necropsy Chamber Concentrations of Vinylidene Chloride Vapor Cumulative Percent Mortality for Male Rats Cumulative Percent Mortality for Female Rats Mean Body Weights for Male Rats Mean Body Weights for Female Rats Summary of hematologic parameters for male rats Suimiary of hematologic parameters for female rats Summary of clinical chemistry parameters for male rats Summary of clinical chemistry parameters for female rats Chromatid and Chromosome Aberrations Observed in Rats Exposed to Vinylidene Chloride Summary of Organ Weights and Organ to Body Weight Ratios for Male Rats Summary of Organ Weights and Organ to Body Weight Ratios for Female Rats Non-tumorous gross pathologic lesions in male rats Non-tumorous histopathologic lesions in male rats Tumors or tumor-like lesions grossly recognized in male rats Histopathologic diagnosis and number of tumors in male rats Number of male rats for which the specified tissue was examined microscopically Non-tumorous gross pathologic lesions in female rats Non-tumorous histopathologic lesions in female rats Tumor or tumor-like lesions grossly recognized in female rats , Histopathologic diagnosis and number of tumors in female rats Number of female rats for which the specified tissue was examined microscopically Page i 1 4 9 22 23A 24 25A 26 28 29 30 31 32 33 34 35 36 37 38 39 40 41 51 63 66 72 75 84 96 100 107 SL 082286 APPENDICES I. II. III. IV. V. VI. VII. VIII. IX. X. Individual Body Weight Data 30 day interim sacrifice-gross and histopathology 6 month interim sacrifice-gross and histopathology 12 month interim sacrifice-gross and histopathology Test material analysis Individual animal data-Hematology Individual animal data-Urinalysis Individual animal data-Clinical Chemistry Individual animal data-Organ Weights Pathology data for unidentified animals 1-1 II-l III-1 IV-1 V-l VI-1 VII-1 VIII-1 IX-1 X-1 SL 082287 SUMMARY Male and female Sprague-Dawley rats (Spartan substrain) were exposed to vinylidene chloride (VDC) by inhalation for 18 months to assess chronic toxicity and oncogenic potential of the subject test material. Rats were exposed to VDC concentrations of 10 and 40 ppm for 6 hours/day, 5 days/week for the first 5 weeks of the study. Based upon the absence of observable treatment-related effects among rats sacrificed after one month of exposure, the exposure concentrations were increased to 25 and 75 ppm VDC. Exposures were continued at these concentrations through the 18th month of the study after which the surviving animals were held until 24 months and then sacrificed. There was no observable increase in mortality of rats of either sex attributable to VDC exposure. Likewise there were no clinical signs of toxicity observed in rats exposed to 25 or 75 ppm VDC during the 18 month exposure period. Clinical chemistry, hematology, urinalysis, and body weight data obtained at selected time intervals throughout the conduct of the study revealed no changes judged as a direct effect of the test material on these parameters or the function of the organ systems evaluated by them. Cytogenetic evaluation of bone marrow preparations from rats of both sexes exposed to 0, 25 or 75 ppm VDC for 6 months did not reveal chromosomal aberrations in either the control or treated animals. A target organ effect resultant from VDC exposure was observed in the liver of rats exposed to either 25 or 75 ppm VDC. This effect, characterized by hepatocellular fatty change in the midzonal region of the hepatic lobule, was observed in both male and female rats of both the 25 and 75 ppm exposure groups as early as the 6 month interim sacrifice in this study. The midzonal fatty change was also observed at the 12 month sacrifice but no indication of progression of this lesion in either severity or incidence was apparent. During the last 6 months of the study, after exposures had been discontinued, this effect was no longer discernible; therefore this alteration was minimal in severity and readily reversible. Although the incidence of several tumors and/or tumor types was found to be statistically increased or decreased in VDC exposed rats when compared to their respective control groups, none of these differences were judged to be attributable to VDC exposure. The observed absence of tumorigenic potential of VDC in rats in the present study is consistent with the findings of other investigators. SIi 082288 1- - INTRODUCTION Vinylidene chloride (1,1-dichloroethylene, VDC) is used extensively as a monomeric intermediate in the production of plastics, particularly in commercial resins and films for food packaging. Thus, potential exposure to VDC could occur by either ingestion of possible residues of unpolymerized VDC in food packaging materials or by inhalation exposure to VDC vapor in air in the workplace. Subchronic toxicity studies of inhaled and/or ingested vinylidene chloride indicate that this material is both a central nervous system depressant and exhibits hepatotoxic (Irish, 1963; Prendergast, et al., 1967) and nephrotoxic (Maltoni, 1977; Henck, et al., 1979) properties. A brief summary of currently available information from chronic toxicity and oncogenicity studies is provided below. Viola and Caputo (1977) have studied the chronic inhalation toxicity and oncogenic potential of vinylidene chloride in two strains of rats. In the first study, male and female Wistar rats were exposed to 0 (control), or 200 ppm vinylidene chloride 4 hours/day, 5 days/week for approximately 5 months. Due to the extent of toxicity observed in the initial portion of this experiment, the exposure concentration of vinylidene chloride was reduced to 100 ppm for the subsequent 6 through 12 month exposure period. Following 12 months of exposure, these animals were held for their lifetime (approximately 22-24 months). In the second study conducted by the same investigators, male and female Sprague-Dawley rats were exposed to 0, 75 and 100 ppm vinylidene chloride for one year and subsequently held for their lifetime. Neither of these studies resulted in any grossly observable oncogenic effects which could be attributed to vinylidene chloride exposure. Histopathologic findings are as yet unreported. A series of studies conducted by Maltoni (1977a, b) investigated the chronic toxicity and oncogenic potential of vinylidene chloride by both the oral and inhalation routes of exposure. Male and female SpragueDawley rats were administered vinylidene chloride by gavage in an olive oil solution at dose levels of 0, 0.5, 5, 10 and 20 mg/kg per day. The test material was administered 4-5 days/week for a total period of 52 weeks, after which the animals were allowed to survive until they died spontaneously. Chronic inhalation exposures have been conducted in Sprague-Dawley rats, Swiss mice, and Chinese hamsters. Rats were exposed SL 082289 2- - to 0, 10, 25, 50, 100 and 150 ppm vinylidene chloride, 4 hrs/day, 45 days/week for 52 weeks and then allowed to survive until they died spontaneously. Similar experiments were conducted in Swiss mice at exposure concentrations of 0, 10 and 25 ppm and in Chinese hamsters at 0 and 25 ppm. In these studies, no evidence for an oncogenic effect associated with vinylidene chloride treatment was recognized in rats or hamsters. However, mice exposed to 25 ppm vinylidene chloride developed a statistically significant increase in kidney adenocarcinomas when compared to control animals. Mice exposed to 10 ppm vinylidene chloride for one year did not show a significant difference in the incidence of kidney tumors from the control group. Lee et al.(1978) exposed CD rats and CD-I mice to 0 or 55 ppm vinylidene chloride 6 hrs/day, 5 days/week for 12 months with no resultant evidence of a significant increase in tumors due to vinylidene chloride. Finally, in a study conducted in this laboratory (Rampy, et al., 1977; Humiston, et al., 1978) male and female Sprague-Dawley rats were administered vinylidene chloride in their drinking water for a period of 2 years at concentrations of 0, 60, 100 and 200 ppm. This corresponded to daily doses calculated on the basis of water consumption of 0, 5.9, 10.0 and 19.3 mg/kg/day for male rats, and 0, 7.5, 12.6 and 25.6 mg/kg/day for female rats. Of the statistically significant deviations from the control group that were seen in this study, only those affecting the liver were considered to be treatment-related. These lesions, evident only upon microscopic examination, were characterized by a minimal amount of hepatocellular fatty change and periportal hepatocellular hypertrophy.This finding occurred in female rats at all exposure concentrations and in male rats only at the highest dose level. There was a similar trend towards an increase in liver lesions in male rats of the 100 ppm exposure group; however, this was not statistically significant. The only statistically significant tumor incidences detected were a decrease in pancreatic nodules in male rats of the 100 ppm treatment group, and an increase in mammary gland fibroadenomas or adenofibromas in the female rats of the 50 ppm treatment group. However these alterations in tumor incidence were not considered to be related to exposure to vinylidene chloride. SL 082290 3- The studies discussed in this report are part of the toxicologic investigations on VDC conducted in the Toxicology Research Laboratory, Dow Chemical USA. These studies were being sponsored by a number of participating companies under the auspices of the Chemical Manufacturer's Association. The objective of this study reported herein was to evaluate the chronic toxicity and oncogenic potential of vinylidene chloride by the inhalation route in male and female Sprague-Dawley rats. Interim results of this study (lacking complete histopathology) have been published previously (Rampy, et al., 1977). This report constitutes the final report for the completed inhalation study and includes data from interim sacrifices conducted at 1 month, 6 months, 12 months and the terminal sacrifice (2 years), as well as all tumor incidence data. SL 082291 4- - MATERIALS AND METHODS General Study Design. Groups of Sprague-Dawley rats equally divided by sex were exposed to vinylidene chloride vapors 6 hr/day, 5 days/week (except holidays) for 18 months. After this treatment period, the remaining animals were allowed to survive until 24 months, at which time they were sacrificed. Initially, exposure concentrations of vinylidene chloride were selected at 0, 10 and 40 ppm. After 5 weeks of exposure the concentrations of VDC were increased to 0, 25 and 75 ppm. These exposure concentrations were maintained throughout the remainder of the 18 month duration of the exposure portion of this study. Interim sacrifices were conducted after 1, 6, and 12 months of exposure to vinylidene chloride. A separate group of 4 rats per sex per exposure level were exposed to 0, 25 or 75 ppm VDC for 6 months at the end of which time these animals were sacrificed and their bone marrow evaluated for cytogenetics. Test Material. Production grade vinylidene chloride was obtained from the Michigan Division plant of Dow Chemical USA., Midland, MI. The test material was stabilized by the presence of an inhibitor (hydroquinonemonomethylether, MEHQ). Samples of the test material were obtained as needed throughout the duration of the study. Upon receipt of a new sample of test material from the production facility, an aliquot of the sample was analyzed by gas chromatography for trace impurities and inhibitor (MEH0) content. A summary of the trace impurity and inhibitor content analyses may be found in Appendix V of this report. Analytical data from these samples indicate that the test material was of a minimum purity of 99%. Exposure Chambers, Vapor Generation and Analysis. Exposures were conducted in 3.7 cubic meter stainless steel chambers under dynamic airflow conditions. Vinylidene chloride vapor atmospheres were generated by metering the liquid test material into a glass vaporization flask at a controlled rate. The temperature of the flask was maintained at approximately 30C. The concentrated VDC vapor was swept by tempered, filtered air into the exposure chamber at an airflow rate calculated to produce the desired concentration. SL 082292 5- - Analysis of the chamber atmosphere was normally performed 2-5 times during the 6 hour daily exposure period. Analyses were conducted by vapor phase infrared spectrometry. A Perkin Elmer model 12A infrared spectrophotometer was employed, a path length of 10 meters and a wave length of 12.6 u were used for the analysis. Chamber concentration was determined by interpolating from a standard curve using peak height measurements. Standards were prepared by injecting a known volume of vinylidene chloride into a SARAN bag filled with a measured amount of filtered, compressed air. Animal 5 and Husbandry. Three groups of Sprague-Dawley (Spartan Research Animals, Haslett, MI) weanling rats, equally divided by sex, were employed in this study. The animals were assigned to treatment groups using a table of random numbers. At the start of exposures, male rats were in the body weight range of 250-300 g and females weighed 190-230 g. Animals were exposed 6 hours a day, 5 days a week; food and water were not available to either exposed or control animals during daily exposures. Animals assigned to VDC-exposure groups were held in an animal holding room during the non exposure period. The control animals were maintained in ambient conditions in an animal holding room (not an exposure chamber), during the daily exposure period. Food and water were available ad libitum at all times other than during exposure. Animals were housed 2 or 3 per cage for the duration of the study. Individual animal identification was assigned when the animal was submitted for necropsy in the pathology laboratory. Routine In-Life Observations. Animals were observed daily during the exposure period for changes in appearance or demeanor. Special attention was given to observing for possible eye or nasal irritation. Body weights were recorded weekly for the first month of exposure, biweekly during the second month of exposure, and a minimum of monthly thereafter for the entire 24 month period of the experiment. Records of mortality were maintained. Clinical Laboratory Studies. Test animals were not predesignated for either interim sacrifice or clinical laboratory parameters. However clinical laboratory evaluations were performed, where appropriate, on the same animals subsequently sacrificed SL 082293 6- - at scheduled interim sacrifices. In all cases these animals were selected from each group prior to the scheduled sacrifice using a table of random numbers. Hematology. Hematologic parameters including red blood cell count, hemoglobin concentration, packed cell volume, total and differential white blood cell counts were determined on 5 rats per sex per exposure group shortly before the 6 and 12 month interim kills. Ten animals/sex/exposure group were used for these evaluations at the 2 year terminal sacrifice. Blood for hematologic determinations was obtained from the tail vein. Urinalysis. Random urine specimens were obtained for 5 rats/sex/exposure group at 6 and 12 months and from 10 rats/sex/exposure group prior to the 24 month terminal kill. Urinalyses included determinations of specific gravity, pH, glucose, protein, ketones, occult blood, bilirubin and urobilinogen (24 months only). Specific gravity measurements were made using a T.S.Meter (American Optical Company, Buffalo, NY); all other parameters were evaluated using Bililabstix (Ames Company, Elkhart, IN). Clinical Chemistry. Clinical chemistry determinations were carried out on serum samples collected from all animals at both the interim and terminal sacrifices. Determinations included serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), and alkaline phosphatase (AP). SGPT determinations were also performed on a selected group of animals 2 and 7 weeks after initiation of exposures. Blood samples for these SGPT determinations were obtained by orbital sinus puncture. Blood glucose values at the 12 month interim sacrifice suggested a treatment-related effect and consequently were repeated at 18 months on 5 rats/sex/exposure group. All the above parameters were performed on all surviving animals at the time of sacrifice (24 month terminal kill). Blood for clinical chemistry parameters, unless specified otherwise, was collected from the severed cervical vessel during the necropsy procedure. Cytogenetic Analyses. Animals for cytogenetic analysis were added to the study following the 1 month interim sacrifice. These rats were caged separately and identified by cage in order to identify them separately from the remainder of the test animals. Following the 1 month interim sacrifice, 4 rats/sex/exposure group were added to the study for cytogenetic evaluation. These rats were exposed for 6 months to 0, 25 or 75 ppm VDC. At the end of the 6 month exposure period, the animals were injected interperitoneally with 4 mg/kg colchicine four hours prior to sacrifice. Femoral bone marrow was SL 08229.4 7- - obtained from each rat, the cells were processed using Hank's balanced salt solution, a 0.5% KCL solution and a 10% acetic acid in methanol fixative (Legator, et al., 1969). The cells were than scored for chromosomal aberrations according to established guidelines (Bender, 1969; Evans, 1962). Pathology During the course of the 24-month experimental period, a concerted effort was made to minimize postmortem autolysis by selecting moribund rats for necropsy examination prior to their natural death. Regardless of whether the rats died during the study, were culled during the study or survived to the terminal necropsy after 734-736 days, a complete gross pathologic examination was performed on each rat by a veterinary pathologist. Every effort was made at autopsy to collect the tissues listed in Table 1 from each rat and preserve in buffered 10% formalin fixative. Rats submitted alive during the course of the study or at the terminal necropsy were anesthetized with methoxyflurane, and the trachea was clamped prior to killing by decapitation. The lungs, trachea and adjacent tissues of all rats were removed from the thoracic cavity as a unit, and the lungs were distended with formalin fixative to their approximate normal inspiratory volume. At the time of a scheduled necropsy (interim or terminal), body weights were recorded after an overnight fast. The brain, heart, liver, kidneys and testes from these rats were removed and weighed. The tissues preserved in formalin fixative were subsequently processed by routine histologic procedures, embedded in embedding medium, sectioned (5-6 y) and stained with hematoxylin and eosin. The tissues taken at autopsy from all rats of the control and high exposure groups, regardless of whether they died, were culled or survived to termination, were processed and examined by light microscopy. Similarly, for rats of the lower exposure group the liver, kidneys, heart, lungs, trachea, spleen, thyroid gland, parathyroid gland, pituitary gland, adrenal glands, stomach, brain (cerebral cortex and cerebellum), and any grossly-visible lesions suggestive of a possible neoplastic process were microscopically examined. The actual number of organs and tissues processed and examined by light microscopy from each exposure group are listed in Tables 18 and 23 for male and female rats, respectively. These tissues were examined for the presence or absence of tumorous and nontumorous alterations. Whenever SL 082295 8- - necessary, special staining procedures were used on selected tissues. These procedures were conducted according to those outlined in the i AFIP manual on histologic techniques. The resultant data were statistically analyzed by Fisher's Exact Probability Test. This test compared the cumulative incidence of each grossly-observed lesion in each exposure group against the cumulative incidence observed in the control group of that respective sex. Statistical evaluations were also performed on the cumulative incidence of all microscopically-visible observations for rats of the high exposure group versus the control group of that sex. Similar statistical evaluations were also performed on microscopically-visible observations for rats of the lower exposure group in those cases in which the number of tissues examined approximated the control group. In all cases, the level of statistical significance chosen was p <0.05. Unidentified Rats. During the conduct of this study, there were several rats for which it was impossible to ascertain the assigned exposure level at the time of presentation for pathologic examination. These rats were autopsied, examined for gross pathologic alterations, and tissues saved for histopathologic examination. The findings of gross and histopathologic examination and list of tissues examined microscopically are included as a separate part of this report. This group consisted of one male rat submitted for autopsy during the 19-24 month interval and four female rats from the terminal kill. All of the pathologic data from these rats are presented in Appendix X. None of these rats had any uniquely different, nontumorous or tumourous pathologic findings compared to those seen in the other control or exposed rats. Rather than remove these rats from the study, they were included for the sake of completeness. Statistical Evaluations. Body weight data, clinical chemistry, hematology, urinalysis (specific gravity) and organ weight data were analyzed using analysis of variance and Dunnett's test (Steel and Torrie, 1960). Data for cumulative mortality, incidence of gross and microscopic pathological findings, and tumor incidence were analyzed by the Fischer's exact test (Siegel, 1956). The level of significance in all cases was chosen as p < 0.05. ^Manual of Histologic and Special Staining Technics, Armed Forces Institute of Pathology, 2nd edition, 1949. SL 0 8 2 2 9XS 9- - RESULTS AND DISCUSSION Chamber Analyses. A summary of analytical values for vinylidene chloride in the exposure chamber atmospheres is shown in Table 2. Due to the alteration of exposure concentrations following the first month of inhalation exposure of rats to vinylidene chloride, the first month and subsequent 17 months of exposure are reported separately in this table. The data presented in Table 2 indicate close control of the vapor generation apparatus and good agreement between the analytical concentrations obtained and the target concentrations for this experiment. There was only one exceptional occurrence in the normal exposure routine for the eighteen months of VDC exposure. On October 22, 1974 (experiment day 207), the test material from a concurrent chronic inhalation study of 2-hydroxyethyl acrylate (HEA, Kociba, et al 1979) was accidentally substituted for VDC in the vapor generating apparatus for the 25 ppm exposure chamber. If one assumed complete volatilization of HEA in the generating apparatus the average concentration of HEA in the exposure chamber would have been 30 ppm. In fact, this was not the case since residual liquid test material was found in the vapor generation flask and the temperature of the vapor generator (30C) was too low to adequately volatilize HEA (minimum temperature for volatilization was 75C under these conditions). It is the judgement of the authors that the actual concentration of HEA in the exposure chamber was in the range of 2-3 ppm and the accidental substitution of this material for a single exposure day had no effect on the outcome of this experiment. In addition Kociba et al. (1979) found that 18 months of inhalation exposure of SpragueDawley rats to 0.5 or 5 ppm HEA did not result in evidence of oncogenicity. Each sample of production grade vinylidene chloride used in this study was checked by gas chromatography to establish identity, inhibitor content, and levels of trace impurities. The impurities and ranges of concentrations found are included in Appendix V. Also included in Appendix V are the calculated concentrations of trace impurities that would be found in a 75 ppm atmosphere of vinylidene chloride assuming total vaporization of the entire sample. Clinical Observations. There were no clinical observations which were interpreted to indicate a consistent treatment-related effect of exposure to either 25 or 75 ppm SL 082297 -10- vinylidene chloride for the rats on this study. No signs of eye or nasal irritation or other changes in appearance or demeanor were observed in any of these animals. Mortality. Cumulative percent mortality for male and female rats exposed to vinylidene chloride vapors are presented in Tables 3 and 4. As indicated in these tables, mortality data was based on a total population of approximately 84-86 animals (depending upon specific group) and did not include animals designated for interim sacrifices or for cytogenetic evaluation. Mortality figures for male rats (Table 3) did not reveal significant increases in mortality as a result of vinylidene chloride exposure. Mortality data for female rats (Table 4) exposed to 25 ppm vinylidene chloride indicate statistically significant increases in mortality when compared to the control group from the 15th through the 22nd months of the study. A trend towards increased cumulative percent mortality was noted in female animals of the 75 ppm exposure group when compared to controls from the 14th month through the end of the study. Statistically significant increased mortality figures were observed for female rats in the 75 ppm exposure group at months 15, 17 and 21 of the study. Although slight increases in cumulative mortality were noted in both vinylidene chloride exposure groups throughout the latter period of this study, there was no indication of any dose-response relationship for this parameter. Additionally, the higher incidence of mortality in the 25 ppm group of female rats and the relative absence of such an effect on the 75 ppm group would indicate that this effect was not a result of VDC exposure. However, the apparent earlier onset of spontaneous mammary tumors in the female treatment groups (Table 22, p. 105) as well as the higher incidence of intercurrent murine pneumonia observed in both males and females during this period of the study (Table 20, p. 87) may have contributed to the increased mortality observed in the treatment groups when compared to controls. Body Weights. A graphic representation of body weight profiles for male and female rats exposed to vinylidene chloride throughout the 2 year duration of this study are shown in Figures 1 and 2 respectively. Summaries of mean body weight for control and exposure groups of male and female rats and the statistically significant values obtained for 08229s -11- this parameter are given in Tables 5 and 6 respectively. Individual body weight data for all animals on this study are included in Appendix I of this report. The mean body weights for male rats exposed to 25 ppm vinylidene chloride were statistically lower than the control group for the first 13 months of exposure to VDC. Subsequently, mean body weights of this group remained lower than controls although they were not statistically decreased in a consistent fashion (see Table 5). Pre-exposure mean body weights for the 75 ppm group were statistically higher than control values and continued to be so for the first 2 weeks of the study. Male rats of the 75 ppm exposure group showed decreased mean body weights from the 6th through the 12th month of the study. A general trend toward decreased mean body weight for animals of this exposure group when compared to controls was observed throughout the remainder of the experimental period (24 months). However, statistically significant differences were only observed at the 17th and 21st month weighings. The absence of a consistent dose-related decrease in mean body weight for male rats exposed to either 25 or 75 ppm vinylidene chloride would argue against the observed differences being attributable to vinylidene chloride exposure. Mean body weights of female rats exposed to either 25 or 75 ppm VDC were generally found to be statistically significantly greater than control means for the first 6 months of the study (Table 6). Subsequent to this period, no consistent effect on body weight could be noted which was attributed to exposure to VDC. As shown in Figure 2, body weight gain for female rats in both VDC exposure groups were comparable to controls for the remainder of the study. Hematoloqy. Hematologic parameters determined at the interim (6 and 12 months) and terminal (24 months) sacrifices on the male and female rats are summarized in Tables 7 and 8, respsectively. Individual animal data for these parameters may be found in Appendix VI of this report. The results of hematology determinations performed on male rats exposed to either 25 or 75 ppm vinylidene chloride revealed no effects which could be attributed to vinylidene chloride exposure at any of the scheduled sacrifices (Table 7). Hematology data obtained on female SL 082299- -12- rats exposed to 25 ppm VDC for 1 year indicated a decreased total white blood cell count when compared to the control mean (Table 8). Samples obtained at the same time interval for female rats exposed to 75 ppm indicated a statistically significant increase in total red blood cell count when compared to control mean. To verify the repeatabi1ity of these observations, the same animals were sampled approximately 3 days following the scheduled 1 year hematology sampling and none of the aforementioned effects were noted. Thus, these effects are attributed to normal variation in these measurements and are not judged to be related to vinylidene chloride exposure. Further support for this interpretation of the data is indicated by the absence of any significant findings in hematology parameters in the animals sacrificed after 2 years on test. Urinalysis. Random urine samples obtained from male and female rats exposed to 0, 25 or 75 ppm vinylidene chloride at the 6 and 12 month interim kills and at the terminal kill did not reveal any consistent effects which were relatable to vinylidene chloride exposure. The individual animal data for urinalysis parameters may be found in Appendix VII of this report. Cl ini cal Chemistry. Clinical chemistry parameters for male rats exposed to vinylidene chloride are summarized in Table 9. A statistically significant increase in serum alkaline phosphatase activity of male rats exposed to 10 ppm VDC at the 1 month sampling period was interpreted as normal variability and not related to vinylidene chloride exposure. At the 1 year interim sacrifice, blood glucose determinations were included in the battery of clinical chemistry tests performed. A significant decrease in blood glucose values for male rats of the 75 ppm exposure group was noted. Blood glucose determinations were repeated on 5 animals per group at 18 months to verify this finding. The observed decrease in blood glucose levels was not repeatable at 18 months nor was it observed at the 2 year terminal sacrifice. Thus, the apparent decrease in blood glucose was considered a reflection of normal variability and of no toxicologic significance. There were no other parameters which were affected as a result of vinylidene chloride exposure. SL 082300 -13- C1ini cal chemistry parameters for female rats exposed to vinylidene chloride are summarized in Table 10. There were no significant differences between control and exposed animals, and no differences attributable to exposure to vinylidene chloride. Cytogenetics. Cytogenetic evaluation of bone marrow cells was conducted at the Biomedical and Comparative Toxicology Laboratory of Dow Chemical USA in Freeport, Texas. As indicated in Table 11, no chromosomal aberrations were found in either the control or treated groups. It was not possible in all cases to find 50 good metaphase spreads on the slides prepared from individual animals as was originally planned. However, sufficient representative spreads were found among some of the animals in each group. Sufficient representative cells were studied to conclude that no increase in the aberration rate was caused by exposure of rats to vinylidene chloride. Organ Weights. A summary of mean organ weights and organ-to-body weight ratios for male rats included in the interim and terminal sacrifices of this study are shown in Table 12. The only effects on organ weights which were noted and interpreted to be resultant from exposure to vinylidene chloride were those in male rats of the 1 year interim sacrifice group. Male rats exposed to either 25 or 75 ppm VDC had decreased fasted body weights with respect to control animals and a concomitant decrease in the liver weight, all of which were statistically significant when compared to the control means. All other statistical differences in organ weights were interpreted as sporadic occurrences and could not be associated with exposure to vinylidene chloride. The data for mean organ weights and organ-to-body weight ratios for female rats included in the interim and terminal sacrifices are shown in Table 13. Female rats exposed to 25 or 75 ppm VDC for 1 year had statistically significant increases in absolute kidney weights when compared to the control mean. A similar trend, although not statistically significant, was also indicated by the kidney weight data from the 2 year terminal sacrifice for animals of these exposure groups. This slight increase in kidney weight of female rats was not supported by any gross or histopathologic observations. SL 082301 -14- Individual animal data for organ weights and organ-to-body weight ratios for the interim sacrifices and the terminal sacrifice are included as Appendix IX of this report. Pathology. The results of gross necropsy and histologic examinations as well as the numbers of tissues examined microscopically are presented in Tables 14 to 18 (males) and 19 to 23 (females). For easy reference, the following is a 1ist of these tables. Table 14 Nontumorous gross pathologic lesions in male rats. Table 15 Nontumorous histopathologic lesions in male rats. Table 16 Tumors or tumor-like lesions grossly recognized in male rats. Table 17 Histopathologic diagnosis and number of tumors in male rats. Table 18 Number of male rats for which the specified tissue was examined microscopically. Table 19 Nontumorous gross pathologic lesions in female rats. Table 20 Nontumorous histopathologic lesions in female rats. Table 21 Tumor or tumor-like lesions grossly recognized in female rats. Table 22 Histopathologic diagnosis and number of tumors in female rats. Table 23 Number of female rats for which the specified tissue was examined microscopically. As expected, a large number of gross and microscopic lesions were recorded for the control and test rats. These lesions included the normal spectrum of spontaneously occurring age-related changes usually encountered in lifetime studies with this strain of rat. Statistical evaluation of the gross pathologic and histopathologic data revealed some observations which had incidence rates which were statistically increased or decreased when compared to the respective control group. Observations that were statistically significantly different from the controls were derived from Tables 14 to 17 for the male rats and Tables 19 to 22 for the female rats and listed as follows: SL 082302 -15- ORGAN SYSTEM & PATHOLOGIC OBSERVATION Males ___ 25 ppm 75 ppm RESPIRATORY SYSTEM Gross Lesions of pneumonia Red foci in lungs Bronchiectasis Nasal/ocular exudate Histology Acute/chronic tracheitis Focal lymphoid infiltrate in trachea Chronic murine pneumonia Focal alveolar histiocytosis Peribronchial lymphoid infiltrate Focal mineralization of intraalveolar septae Chronic pulmonary lesions characterized by edema, interstitial thickening, fibrosis, inflannation with or without atelectasis (secondary to advanced cardiac or renal lesions) Mediastinal lymphoid hyperplasia, second ary to chronic murine pneumonia Inc. -- Inc. Inc. Inc. Dec. Inc. -- Dec. Dec. Dec. N.E. Inc. Inc. Inc. Inc. Inc. -- Inc. Dec. Dec. Inc. LIVER Gross Accentuation of lobular pattern Red subcapsular foci Histology Lobular atrophy Focal biliary hyperplasia Focal periportal fibrosis Focal mononuclear cell infiltrate Foci of ground-glass appearing hepato- cytes Fatty change - midzonal Sinusoidal dilatation Dec. Dec. -- Dec. . -- -- Dec. -- Dec. Dec. Dec. Dec. -- -- URINARY SYSTEM Gross Dilated renal pelvis Chronic renal disease -- Dec. -- ____ Females 25 ppm 75 ppm Inc. -- Inc. -- Inc. -- Inc. Dec. -- -- Inc. -- Inc. -- Inc. Dec. -- N.E. Inc. -- Dec. Dec. -- -- -- Dec. ----------- ---------- Dec. Dec. -- Dec. Inc. -- = Dec. -- Results are listed on the basis of whether the incidence rate for each respective observation was statistically increased (Inc.), decreased (Dec.) or comparable to the control group of that sex (----- ). N.E. - Not examined microscopically in numbers comparable to controls. SL 082303 -16- ORGAN SYSTEM & PATHOLOGIC OBSERVATION Males 25 ppm 75 ppm Females 25 ppm 75 ppm PITUITARY Gross Increased size or irregular shape Histology Adenoma Total number with pituitary tumors Dec. Dec. Dec. Dec. Dec. Dec. Dec. Dec. -- PANCREAS Histology Islet cell adenoma N.E. Dec. N.E. MAMMARY GLAND Gross Hyperplasia Number of rats with 3 subcutaneous tumors Histology Adenocarcinoma Total number of rats with a subcutaneous and/or mammary tumor -- -- -- -- Inc. Inc. -- Dec. Inc. Inc. OTHER Ovarian cyst Splenic atrophy Chronic focal keratitis Skeletal muscle atrophy Lymph node edema, cystic, pigment, etc. Cannibalism Dec. -- N.E. -- Dec. Dec. Inc. Dec. -- -- ----- -- - - N.E. -- -- Inc. -- -- -- Dec. -- Results are listed on the basis of whether the incidence rate for each respective observation was statistically increased (Inc.), decreased (Dec.) or comparable to the control group of that sex (----- ). N.E. - Not examined microscopically in numbers comparable to controls. SL 082304 -17- ORGAN SYSTEM & PATHOLOGIC OBSERVATION Males 25 ppm 75 ppm Females 25 ppm 75 ppm CARDIOVASCULAR SYSTEM Gross Dilated inelastic appearance of aorta Histology Minimal focal myocardial degeneration Severe focal myocardial degeneration and fibrosis Lesions of mesenteric periarteritis Mineralization of blood vessels Dec. Inc. Dec. -- Dec. -- Dec. Dec. Dec. Dec. -- -- Dec. -- -- GASTROINTESTINAL Gross Inflammation of salivary gland Soiling of perineal region Gastric mineralization Dec. -- Dec. -- Dec. """ -- -- -- -- """ ADRENAL Histology Hyperplastic focus of cortex Hyperplastic focus of medulla Focal lipomatosis Dec. -- Dec. -- Dec. -- Dec. Dec. -- Dec. THYROID Gross Increased size Histology Adenocarcinoma Total number with thyroid tumor Dec. -- -- Dec. Dec. Dec. Dec. Dec. -- -- -- PARATHYROID Gross Hyperplasia Histology Hyperplasia Dec. Dec. -- -- -- -- ----- . -- OVARY Gross Ovary - tumor -- -- Dec. -- Results are listed on the basis of whether the incidence rate for each respective observation was statistically increased (Inc.), decreased (Dec.) or comparable to the control group of that sex (----- ). SL 082305 -18- Gross and histologic examination of the respiratory tissues of male and female rats exposed to 25 or 75 ppm of VDC revealed a statisticallyincreased incidence of lesions typical of chronic murine pneumonia, an infectious process due to Mycoplasma pulmonis. This disease was first recognized during the 13-18 month time interval and increased in inci dence as the study progressed. The incidence of lesions of chronic murine pneumonia was much lower in the control groups. The control rats were not housed in exposure chambers during the study, although the control cages were located in the same room as the rats with the infec tious disease. This physical separation of control and exposed rats, even though in the same room, probably decreased the rate of spread of this infectious disease. In view of these factors, plus the fact that this infectious disease has previously been observed at a higher inci dence in control groups from other studies, it was concluded that the lesions of chronic murine pneumonia and its associated bronchiectasis, tracheitis, nasal and ocular exudate, focal keratitis and mediastinal lymphoid hyperplasia were not considered to be the result of exposure to 25 or 75 ppm of VDC. As a result of the increased incidence of the more advanced lesions of chronic murine pneumonia noted in lungs of rats exposed to 25 or 75 ppm of VDC, there was a corresponding statistical decrease in the incidence rates for some of the minor pathologic observation in the lungs of rats at both exposure levels, presumably due to masking of these lesions by the pneumonia. Advanced chronic renal disease was the primary cause of death or reason for removing male rats from this study. Most of these rats also exhibited other organ system lesions associated with chronic renal failure and a uremic state. The female rat of this strain has a high spontaneous incidence of subcutaneous tumors in the mammary gland region and was frequently the reason for being culled during the study. Because of the size, number, and location of these masses in the mammary gland region they frequently show pressure necrosis, ulcerations, and subsequent homorrhage. Acute death may result from the blood loss in some of these animals while others may survive the hemorrhagic episode with histopathologic observations in a multitide of tissues that are a result of the hypoxic state due to blood loss. SL 082306 -19- Gross and histologic examination of the livers of rats exposed to 25 or 75 ppm VDC indicated statistical decreases in the incidence rates of various degenerative or inflammatory processes; these were considered to be of no toxicologic significance. However, the livers of female rats exposed to 75 ppm of VDC had a statistically increased incidence of midzonal hepatocellular fatty change while the group of females exposed to 25 ppm VDC showed a trend towards an increased incidence which was not statistically significant. This midzonal hepatocellular fatty change, which was considered to be the result of VDC exposure, occurred at an increased incidence only in those rats submitted for necropsy during the 18-month exposure interval and was no longer present during the 6-month post-exposure period. This midzonal hepatocellular fatty change was comparable to that previously reported in both male and female rats from this study which were killed and examined following 6 and 12 months of exposure. Therefore this change is considered a minimal exposure-related effect that was readily reversible and non progressive in nature. The liver change was not observed in males at 18 months although it had been observed in males killed following 6 and 12 months of exposure. In all probability the absence of fatty liver was due to the fact that many of the male rats were culled from this study due to advanced chronic renal disease and were in an emaciated and debilitated state. Although the midzonal hepatocellular fatty change in female rats was attributed to VDC exposure, there was no increase in the incidence of hepatocellular fatty change when expressed on a basis of combined numbers of female rats with any type of hepato cellular fatty change without regard to specific location in the liver lobule (Table 20). Examination of the kidneys, cardiovascular system, gastrointestinal system, adrenal glands, parathyroid glands, and other tissues revealed statistically decreased incidence rates of various nontumorous lesions which were considered of no toxicologic significance. Female rats exposed to 75 ppm of VDC had a statistical increase in the incidence rate of ovarian cysts; this was not observed in the group exposed to 25 ppm of VDC, and may or may not have been associated with the exposure to VDC. However, in view of the absence of any other associated ovarian or uterine changes, it is of questionable toxicologic significance. SL 082307 -20- In regard to tumors, there were statistical decreases in the incidence rates of pancreatic islet cell adenomas, pituitary adenomas and thyroid adenocarcinomas in male rats exposed to 75 ppm of VDC. Male rats ex posed to 25 ppm of VDC had a statistical decrease in the incidence of pituitary adenomas. In female rats exposed to 75 ppm of VDC, there were statistical increases in the total number of rats with a microscopically diagnosed subcutaneous and/or mammary gland tumor (Table 22). Upon gross examination there was an increased number of female rats in this group which contained 3 subcutaneous tumors per rat (Table 21) while the same group showed a decreased incidence of grossly detectable mammary hyperplasia (Table 19). In females exposed to 25 ppm of VDC, there were statistical decreases in the incidence rates of pituitary adenomas and thyroid adenocarcinomas plus statistical increases in the incidence rates of mammary adenocarcinomas (Table 22). Upon gross examination, there was an increase in the total number of rats with 3 subcutaneous tumors/rat. The number of rats in this group with less than or greater than 3 subcutaneous tumors per rat was comparable to the controls (Table 21). Although' there was a statistical increase in the incidence of mammary adenocarcinomas noted in females exposed to 25 ppm of VDC, there was no difference when a comparison was made of all malignant tumor types of mammary and/or subcutaneous tissue origin (Table 22). In addition, the incidence of mammary gland adenocarcinoma in controls of this study was disproportionately low compared to our historical control values. The total number of females of the group exposed to 75 ppm of VDC with a subcutaneous and/or mammary gland tumor was statistically increased. Although this incidence rate was increased, it is comparable to controls of other recently conducted studies. The added stress of intercurrent murine pneumonia, differences in handling control and exposed animals, as well as the midzonal fatty liver changes, may have contributed to the variable incidence of these mammary tumors. The incidence and onset of these mammary tumors is not inter preted to be a direct carcinogenic effect of VDC exposure. In addition, a 2-year water ingestion study of VDC conducted in this rat strain at this laboratory (Humiston et al.) did not indicate a carcinogenic effect in mammary tissue or any other organ system. SL 082308 -21- The total incidence of histopathologically diagnosed primary neoplasms, benign plus malignant, derived from Table 17 (males) and Table 22 ( females) is as follows: Concentration of VDC in air (pnm) Total Number of Primary Neoplasms Male Female Total No. of Rats in Group Male Female Average Number of Primary Neoplasms/ Rat in Group Male Female 0 145 248 86 84 1.68 2.95 25 101 220 85 86 1.18 2.55 75 115 235 86 84 1.33 2.79 These tumor incidence figures for male and female rats from the various exposure levels and controls are comparable to historical controls. Therefore, none of the statistically significant increases or decreases in tumor incidences were considered to be a direct effect of exposure to 25 or 75 ppm of VDC. SL 082309 -22- SUMMARY AND CONCLUSIONS Rats were exposed to VDC concentrations of 10 and 40 ppm for the first five weeks of this study. Based upon the absence of observable treatmentrelated effects in the data from rats sacrificed after 1 month of exposure, the decision was made to increase exposure concentrations to 25 and 75 ppm VDC. Exposures were continued at these VDC concentrations through the 18th month of the study, after which the surviving animals were held until 24 months and then sacrificed. There was no observable increase in mortality of rats of either sex attributable to VDC exposure. Likewise there were no clinical signs of toxicity or irritation of the eyes or nares observed in rats exposed to -25 or 75 ppm VDC during the 18 month exposure period. Clinical chemistry, hematology, urinalysis, body weight data and organ weights obtained at selected time intervals throughout the conduct of the study revealed no changes which could be judged as a direct effect of the test material on these parameters or the function or organ systems evaluated by them. Cytogenetic evaluation of bone marrow preparations from rats of both sexes exposed to 0, 25 or 75 ppm VDC for 6 months failed to reveal chromosomal aberrations in either the control or treated animals. Although the incidence of several tumors and/or tumor types were found to be statistically increased or decreased in VDC-exposed rats compared to controls, none of these statistically significant differences were judged to be attributable to VDC exposure. The majority of altered tumor incidence rates were observed to be associated with intercurrent disease (murine pneumonia), commonly found geriatric lesions in this strain of rat, or both. The total incidence of histologically diagnosed primary neoplasms (benign and malignant) was similar in control and VDCexposed groups of both sexes. In addition the tumor incidence data for both control and treated rats in this study was comparable to historical control data for the Sprague-Dawley rat (Spartan substrain) used by this laboratory for several studies of similar design and duration. The observed absence of tumorigenic potential of VDC in rats in the present study is consistent with the findings of other investigators (Maltoni, 1977a, b; Lee et al, 1978; Humiston, et al, 1978). SL 082310 -23- The only target organ effects resultant from VDC exposure were observed in the liver of rats exposed to either 25 or 75 ppm VDC. This effect, character!zed by hepatocellular fatty changes in the mid-zonal region of the hepatic lobule was observed in both male and female rats of both the 25 and 75 ppm exposure groups as early as the six month interim sacrifice in this study. Similar observations were also made in another study in which rats were exposed to 25 or 75 ppm VDC for 90 days (Balmer et al, 1975). The midzonal fatty change was also observed at the 12 and 18 month sacrifices but no indication of progression of this lesion in either severity or incidence was apparent. By the 18th month of the study the incidence of this change was no longer increased in male rats exposed to VDC when compared to controls. However, female rats of the 75 ppm exposure group had a significantly higher incidence of hepatic fatty change than did their controls and a trend towards an increased incidence (not statistically significant) was apparent in female rats of the 25 ppm group. During the last 6 months of the study after exposures had been discontinued the effect was apparently no longer discernible. Therefore this alteration was minimal in severity, readily reversible and non-progressive in nature. In summary, inhalation exposure of male and female rats to 25 or 75 ppm VDC for 18 month resulted in no observable indications of tumorigenic potential under the conditions of this experiment. Minimal hepatocellular fatty change in the mid-zone of the hepatic lobule was the only apparent treatment-related effect of VDC exposure. This finding was observed in rats of both sexes and at both exposure concentrations, appeared to occur in an exposure-related fashion and was clearly reversible after cessation of exposure. SL 082311 -23A- Authors: A M. McKenna, Ph.D. Diplomate, American Board of Toxicology Group Leader Subchronic and Chronic Toxicology TT'/'^ _________ J^ F, Quast, D.V.M., Ph.D. / Diplomate, American College of 1/eterinary Pathologists Associate Scientist Pathology Group Leader /J, /rrZ~~ tyifkel, B.S, Seniioorr^ RRtesearch Bio'logist Subchronic and Chronic Toxicology Jh 3/' /Pa 4/A, >71^ , s ^ -y 'Sz M. F: Palmer, M.S. / ^ Research Biologist t 2- <_ n . rxamjjjr } i i i, u . / v Diplomate, American Board of Toxicology Research Manager Industrial Hygiene Laboratory Reviewed by: fh ft _______/ 3 B. A. Schwetz, D.V.I'O, Ph.D. Director Toxicology Research Laboratory l.~L_ SL 082312 -24- REFERENCES Balmer, M. F., L. W. Rampy and J. F. Quast (1975). 90-day and long-term repeated inhalation studies of vinylidene chloride in rats: Interim report after 14 months. Toxicology Research Laboratory, Dow Chemical U.S.A. (report to C.M.A.). Bender, M. A. (1 969). Human Radiation Cytogenetics. In_L. G. Augenstein, R. Mason and M. Zelle (Eds.), Advances in Radiation Biology, Academic Press, New York, pp 215-275. Buckton, K. E. and H. J. Evans. Methods for the Analysis of Human Chromosome Aberrations. World Health Organization, Q. Corp., 49 Sheridan Ave., Albany, NY 12210. Evans, H. J. (1962). Chromosome Aberrations Induced by Ionizing Radiations. In G. H. Bourne and J. F. Danielli (Eds.), International Review of Cytology, V. 13, Academic Press, New York, pp 221-321. Henck, J. W., J. F. Quast and L. W. Rampy (1979). A comparison of four mouse strains exposed to subchronically inhaled vinylidene chloride. Toxicology Research Laboratory, Dow Chemical U.S.A. Humiston, C. G., U. F. Quast, C. E. Wade, J. Ballard, J. E. Beyer and R. W. Lisowe (1978). Results of a two year toxicity and oncogenicity study with vinylidene chloride incorporated in the drinking water of rats. Toxicology Research Laboratory, Dow Chemical, U.S.A. Irish, D. D. (1963). in Industrial Hygiene and Toxicology, Vol. 2, Toxicology (F. A. Patty, ed.) 2nd rev. ed., pp. 1305-1307. Wiley-Interscience, New York. Kociba, R. J., D. G. Keyes, D. J. Schuetz, H. 0. Yakel, M. E. Balmer and L. W. Rampy (1979). Results of a two-year inhalation toxicity study of 2-hydroxyethyl acrylate (HEA) in rats. Toxicology Research Laboratory, Dow Chemical U.S.A. Lee, C. C., J. C. Bhandari, J. M. Winston and W. B. House (1978). Carcinogenicity of vinyl chloride and vinylidene chloride. J. Toxicol. Environ. Health 4: 15-30. Legator, M. L., K. A. Palmer, L. Green and K. W. Petersen (1969). Cytogenetic studies in rats of cyclohexyl amine, a metabolite of cyclamate. Science, 165: 1139-1140. Maltoni, C. (1977a). Recent findings on the carcinogenicity of chlorinated olefins. Environ HIth Persp; 21: 1-5. Maltoni, C., G. Cotti, L. Morisi, P. Chieco (1977b). Carcinogenicity bioassays of vinylidene chloride. La Medicina del Lavaro, 68: 241-262. SL 082313 -25Prendergast, J. A., R. A. Jones, L. J. Jenkins and J. Siegel (1967). Effects on experimental animals of long term inhalation of trichloroethylene, carbon tetrachloride, 1,1,1-trichloroethane, dichlorodifluoromethane and 1,1-dichloroethylene. Toxicol Appl Pharmacol 1_0: 270-289. Rampy, L. Vi., J. F. Quast, C. G. Humiston, M. F. Balmer and B. A. Schwetz (1977), Interim results of two year toxicological studies in rats of vinylidene chloride incorporated in the drinking water or administered by repeated inhalation. Environ. Hlth. Persp., 21: 33-43. Siegel, S. (1956). "Non-Parametric Statistics for the Behavioral Sciences" McGraw-Hill Book Co., New York. Steel, R. G. D. and Torrie, H. H. (1960). "Principles and Practices of Statistics". McGraw-Hill Book Co., New York. St* 082314 -25A- VI NYU DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS HET K-2197-(5) QUALITY ASSURANCE STATEMENT This report represents data generated prior to the enactment of the FDA Good Laboratory Practice Regulations. The study was conducted according to standards used in this laboratory at that time. The report accurately reflects all of the data generated. All data and reports are located at the submitting laboratory. STUDY STARTED: 03/20/74_________ REPORT ISSUED: 09/08/82 FINAL REPORT AUDITED: 06/22 & 23/81 REPORTED: 06/24/81 W. E. Hoover (Dati Quality Assurance Toxicology Research Laboratory Health & Environmental Sciences 1803 Building Dow Chemical U.S.A. Midland, MI 48640 /? SL 082315 BODY W EIGHT MEAN FIGURE 1 Mean Body Weights of Male Rats Exposed to VDC 0 CONTROL + 25 PPH ^ => 75 PPH FIGURE 2 Mean Body Weights of Female Rats Exposed to VDC CD - CONTROL + ** 25 PPH * = 75 PPM BOOT WEIGHT MEAN -27- A0j3 to V -28- TABLE 1 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Tissue Samples Obtained and Preserved from All Animals at Necropsy esophagus salivary glands stomach large intestine pancreas 1 i ver kidneys urinary bladder prostate accessory sex glands epididymides testes ovaries oviducts3 mediastinal lymphoid tis: (thymus, mediastinal lyi uterus mammary tissue (female 3) cerebrum lymph nodes (mesenteric) ^rain cerebellum with brain stem heart pituitary gland aorta spinal cord skeletal muscle peripheral nerve adrenal glands trachea lungs (bronchi) thyroid gland parathyroid gland3 nasal turbinates adipose tissue sternum and sternal bone marrow*3 skin spleen any gross lesion or mass eyesc aThess tissues were e'valuated histologically on ly to the extent that they were included in the routine sections of adjac ent larger organs. ^Sternum and enclosed bone marrow were to be evaluated histologically only if indicated by abnormal findings in the hematological studies. cEye$ were saved in formalin if the rat died or was culled from the study. If the rat was from the interim or terminal kills, a portion of these were fixed in Zenker's fixative and the remainder in formalin. Only selected animals had their eyes microscopically examined. Si* 082318 -29- TABLE 2 VI NY LIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Chamber Concentrations of Vinylidene Chloride Vapor First Month Months 2-18 Target Concentration (ppm) Mean Analytical Concentration S.D. (ppm) 10 40 9.5 35. 8 =2.5 6. 2 25 75 25.4 72.6 4.6 7.5 % of Exposure Days Within of Target Concentration 18 57 52 69 % of Exposure Days Within 25% of Target Concentration 68 86 81 96 Range of Concentration 5.0-13.7 20.0-45.,1 12..0-39.5 52.1-96.0* *Single days at 35, 42.4, 46.5, 47 , 47.!3, 47. 7, and 49 ppm were recorded SL 082319 -30- table 3 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS CUMULATIVE PERCENT MORTALITY FOR MALE RATS Months on Study Number of Rats Alive on Day Oa Control Number Dead (* Dead) 86 1 1 (1) 2 1 (1) 3 1 (1) 4 1 (1) S 1 (1) 6 3 (4) 7 4 (5) 8 5 (6) 9 5 (6) 10 5 (6) 11 6 (7) 12 8 0) 13 9 (11) 14 10 (12) IS 14 (16) 16 19 (22) 17 23 (27) 18 27 (31) 19 32 (37) 20 39 (45) 21 49 (57) 22 54 (63) 23 63 (73) 24 72 (84) 25 73 (85) Terminal Kill 30-Day Interim Kill 6-Month Interim Kill 12-Month Interim Kill 26 Weeks.Cyt-genetic Killb 13 4 5 S 4 Total Rats in Study 104 Exposure Level 25 ppm Number Dead [% Dead) 85 3 (4) 3 (4) 3 (4) 4 (5) 4 (5) 4 (5) 4 (5) 5 (6) 5 (6) 6 (7) 6 (7) 7 (8) 8 (9) 8 (9) 8 (9) 17 (20) 18 (21) 25 (29) 36 (42) 47 (55) 50 (59) 58 (68) 65 (77) 72 (85 72 (85) 13 4 5 5 3 103c 75 ppm Number Dead {% Dead) 86 1 (1) 1 (1) 2 (2) 3 (4) 3 (4) 4 (5) 4 (5) 5 (6) 5 (6) 7 (8) 8 (9) 8 (9) 9 OD 10 02) 12 (14) 12 (14) 16 09) 27 (31) 37 (43) 47 (55) 56 (65) 66* (77) 71 (83) 74 (86) 78 (91) 8 4 5 5 4 104 Excludes those rats used in the Interim kills and the cytogenetic kill. kfour rats per exposure level were added one month after start of study. includes one rat designated for cytogenetics study but not used due to death six weeks prior to cytogenetic kill. Statistically different from control data when analyzed using Fisher's Exact Probability test, p<0.05. SL 082320 -31- table 4 VI NY LI DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS CUMULATIVE PERCENT MORTALITY FOR FEMALE RATS Months on Study Number of Rats Alive on Day 0a 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 CO Control NumDer Dead ( * Dead) 0 (0) 0 (0) 0 (0) 1 (1) 1 (1) 1 (1) 1 CD 1 (D 1 (D 1 0) 2 (2) 2 (2) 4 (5) 4 (5) 5 (6) 8 (10) 9 OD 16 (19) 23 (27) 30 (36) 39 (46) 46 (55) 56 (67) 64 (76) 65 (77) Terminal Kill 30-Day Interim Kill 6-Month Interim Kill 12-Month Interim Kill 26 Weeks.Cytogenetic Kill 19 4 5 5 4 Total Rats in Study 102 Exposure Level 25 ppm Number Dead f * Dead) 86 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (D 1 (1) 1 (D 3 (4) 3 (4) 6 (7) 6 (7) 9 (ID 10 02) 18* (2D 19* (22) 19* (22) 29* (34) 37* (43) 49* (57) 55* (64) 59* (69) 65 (76) 72 (84) 75 (87) 11 4 5 5 4 104 75 ppm Number Dead {% Dead) 84 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 0) 1 (D 1 (D 1 (D 1 (D 1 (D 5 (6) 6 (7) 7 (8) 13* 06) 16 (19) 18* (21) 20 (24) 29 (35) 41 (49) 51* (61) 54 (64) 61 (73) 68 (81) 68 (81) 16 4 5 5 4 102 Excludes those rats used in the interim kills and the cytogenetic kill. ^Four rats per exposure level were added one month after start of study. `Statistically different from control data when analyzed using Fisher's Exact Probability test, p<0.05. SL 8232l -32- TABLE 5 VI NYU DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Mean Body Weights for Male Rats Study Time Month 00 8 13 20 1 26 39 2 52 3 79 4 113 5 140 6 174 201 209 212 7 219 8 233 9 260 10 287 11 321 12 348 13 375 14 409 15 436 16 463 17 497 18 524 19 551 20 578 21 612 22 646 23 677 24 704 Controls 275.82 319.74 346.77 378.09 399.47 428.59 448.09 489.23 518.47 536.55 561.78 579.24 572.32 601.29 565.01 579.07 598.12 603.05 615.80 639.17 637.45 638.81 638.46 631.71 659.41 627.18 606.18 609.37 607.78 597.50 574.96 587.27 25 ppm 276.05 305.84* 340.06* 363.86* 385.93* 412.48* 431.80* 468.71* 500.00* 512.86* 528.74* 528.15* 528.50* 563.12* 535.02* 550.81* 555.11* 569.36* 586.04* 593.14* 611.82* 613.47 623.26 618.00 614.94* 585.60* 596.84 575.20 582.11 569.04 554.65 549.69 75 ppm 282.56* 328.20* 353.56* 375.61 396.02 423.88 447.24 488.15 518.94 539.54 549.27 556.47* 552.79* 557.76* 558.50 559.31* 565.36* 572.19* 588.57* 586.36* 625.81 639.74 645.81 635.24 628.62* 618.39 583.75 585.84 563.10* 541.85 536.13 529.55 *Significantly different from control mean, p<.05. sXj 082322 -33- TABLE 6 VINYLI DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Mean Body Weights for Female Rats Study Time Month Day 00 8 13 20 1 26 39 2 52 3 79 4 113 5 140 6 174 201 209 212 7 219 8 233 9 260 10 287 11 321 12 348 13 375 14 409 15 436 16 463 17 497 18 524 19 551 20 578 21 612 22 646 23 677 24 704 Controls 210.24 230.20 238.48 252.87 259.52 269.89 278.78 294.14 311.28 322.03 332.67 336.18 337.11 332.63 331.73 338.73 339.60 343.67 356.89 367.94 376.74 379.60 386.38 390.53 406.30 396.26 395.10 414.86 443.06 412.23 420.33 427.00 25 ppm 212.58 221.38* 243.40* 246.59* 258.60 277.79* 280.84 301.51* 317.23 329.17 342.63* 331.11 334.58 335.27 335.80 338.93 348.01 362.06* 370.98* 377.14 375.25 386.23 391.36 397.31 411.39 419.26 429.48 405.68 411.72 435.19 460.71 462.67 75 ppm 203.22* 241.57* 247.40* 255.68 264.34 280.79* 289.26* 308.79* 325.10* 335.96* 342.12* 339.93 336.71 343.73* 340.29 340.23 348.26 356.57 368.90 363.14 387.52 397.57* 402.62 397.10 419.64 426.13 421.21 413.13 448.65 457.27 469.91 438.62 ^Significantly different from control mean, p<.05. SL 082323 TABLE 7 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Summary of Hematology Values for Male Rats -n- Exposure Level (ppm) 0 25 75 Number of Rats 5 5 5 Time 6 mo. 6 mo. 6 mo. PCV % 53.73.1 53.20.4 54.40.5 RBC x 10**/mm"* 8.000.49 7.46+0.56 7.70+0.66 Hgb q/lOOnl 17.1+0.8 17.4+0.4 17.3+0.3 WBC x 10`*/mm'* 11.11.2 10.3+2.1 16.813.1 Differential Count Neut. sea- B/J Lym Mon Eos. 15 0 81 3 18 0 78 2 19 0 75 5 1 2 1 Bas 0 0 0 0 5 1 yr. 50.6H.7 8.48+0.44 16.40.6 9.41.8 17 0 82 1 00 25 5 1 yr. 50.6+2.9 8.46+0.28 17.1+0.8 7.72.1 22 0 75 1 2 0 75 5 1 yr. 53.10.7 8.92+0.32 17.4+0.5 10.2+2.6 16 0 81 1 2 0 0 10 2 yrs. 45.3+8.1 7.511.1 14.6+2.1 18.77.2 35 0 61 3 1 0 25 10 2 yrs. 43.4+6.5 7.09+1.1 14.412.1 17.3+6.9 38 0 58 3 1 0 75 10 2 yrs. 47.3+5.3 7.61+0.67 15.6H.4 15.1+4.8 38 0 57 4 1 0 No significant differences between control and exposed groups by Analysis of Variance and Dunnett's test (p<0.05). SL 08232-4 TABLE 8 VINYL!DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Summary of Hematology Values for Female Rats Exposure Level (PP"i) 0 25 75 Number of Rats 5 5 5 Time 6 mo. 6 mo. 6 mo. PCV % 51.7+3.4 49.7+3.7 52.7+3.3 RBC x 106/mm3 7.340.48 6.650.52 7.720.90 Hgb q/lOOml 16.510.5 16.2+1.3 17.4+0.8 WBC x 103/mm3 10.012.2 8.013.1 9.6+1.4 Differential Count Neut. Seg. B/J lym Hon. Eos. 9 0 86 4 18 0 77 4 13 0 83 3 1 1 1 8a s 0 0 0 0 5 1 yr. 46.5+1.5 7.340.22 15.3+0.4 7.2H.5 14 0 83 2 1 0 25 5 1 yr. 48.3+2.9 7.7410.46 15.8+1.1 4.Oil.0* 11 0 87 0 2 0 75 5 1 yr. 46.4+1.1 7.84+0.15* 15.5+0.3 6.6H.3 19 0 78 1 2 0 0 5 1 yr.** 46.9+1.2 7.32+0.26 15.2+0.3 7.5H.4 25 5 1 yr. 45.1+2.8 7.3910.60 . 14.9H.1 6.4+1.2 75 5 1 yr. 45.8+3.1 7.4610.56 15.0H.1 9.61.0 0 10 2 yrs. 39.06.9 6.04+1.3 12.7+2.4 13.2+4.8 40 1/0 56 2 1 0 25 10 2 yrs. 39.9+8.5 6.34+1.41 13.4+2.9 15.1+6.8 36 1/0 58 2 3 0 75 10 2 yrs. 41.3+3.4 6.66+0.49 13.8+1.0 14.315.4 42 0 53 3 2 0 SL 082325 Significantly different from control group by Analysis of Variance and Dunnett's test, p<0.05. Additional samples taken 3 days later. -36- TABLE 9 VINYLI DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Summary of Clinical Chemistry Values for Male Rats Exposure Level (ppm) 0 10 40 0 10 40 0 25 75 0 25 75 0 25 75 0 25 75 0 25 75 Time N 2 weeks 2 weeks 2 weeks 5 5 5 1 month 1 month 1 month 4 4 4 7 weeks 7 weeks 7 weeks 4 4 4 6 months 6 months 6 months 5 5 5 1 year 1 year 1 year 5 5 5 18 months 18 months 18 months 5 5 5 24 months 13 24 months 13 24 months 8 SGPT mU/ml 37.0+5.9 37.6+7.5 29.02,8 30.53.1 29.33.3 26.81.7 26.82.9 24.82.1 23.5+4.0 31.07.0 27.0+4.0 30.0112.0 44.4+4.4 47.45.6 40.4+5.5 34.016.0 58.0163.0 40.019.0 BUN mg/100ml Aik Phos. mU/ml Glucose mq/100ml 21.1+4.8 22.9+2.5 20.6+2.1 141.0+13.6 173.0+18.8* 117.3+10.4 17.6+0.9 22.217.1 16.612.0 15.53.0 18.5+6.2 17.0+5.6 29.0+8.0 60.0+67.0 32.017.0 109+20.0 12426.0 11411.0 85.6H2.7 104.630.2 111.226.8 94.Q24.0 106.0+33.0 99.0H5.0 134.619.6 124.89.4 102.87.0* 92.0116.0 90.016.0 96.016.0 103.0H8.0 105.0126.0 93.0119.0 *Significantly different from control group by Analysis of Variance and Dunnett's test, p<0.05. SL 082326 -37- TABLE 10 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Summary of Clinical Chemistry Values for Female Rats Exposure Level (ppm) 0 10 40 0 10 40 0 25 75 0 25 75 0 25 75 0 25 75 0 25 75 Ti me N 2 weeks 2 weeks 2 weeks 5 5 5 1 month 1 month 1 month 4 4 4 7 weeks 7 weeks 7 weeks 4 4 4 6 months 6 months 6 months 5 5 5 1 year 1 year 1 year 5 5 5 18 months 18 months 18 months 5 5 5 24 months 19 24 months n 24 months 16 SGPT mU/ml 32.85.4 37.42.3 31.24.2 23.83.3 24.Oil.4 23.33.9 28.0+7.1 25.33.5 24.82.4 28.02.0 29.06.0 22.0+6.0 37.4+5.8 37.45.7 38.49.9 3712 377 32 8 BUN mq/lOOml Aik Phos. mU/ml Glucose mq/100ml 22.81.7 22.32.4 23.94.3 104.3+33.0 121,525.6 114.020.7 26.33.0 26.2+0.8 22.24.5 18.015.5 14.915.5 14.5+1.7 3030 22+10 3654 108,033.0 119.069.0 80.0+12.0 70.616.6 65.617.6 77.2+17.1 12495 94+79 92+55 135.88.6 137.Oil 2.2 137.414.6 1009.0 94.010.0 97.07.0 101+23 8929 9520 No significant differences between control and exposed animals by Analysis of Variance and Dunnett's test, p<0.05. SL 82327 -38- table ll VINYLIDENE CHLORIDE: A CHROMIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Chromatid and Chromosome Aberrations Observed in Rats Exposed to Vinylidene Chloride Multiple Mi seellaneous Chromatid Chromosomes Number Number Aberrations/ Aberrations/ Aberrations/ Aberrations/ Abnormal Cells Cells Cells Cells Cells Cells Treatment Sex Scored Scored (1) Scored (2) Scored (3) Scored (4) Scored (5) Control Male 34 23 40 38 0 0 0 0 0 0 0 0 0 00 0 00 0 00 0 00 Control Female 0 50 0 40 0 0 0 0 0 0 0 0 0 00 0 00 0 00 0 00 25 ppm^ Male 50 29 50 0 0 0 0 0 0 0 00 0 00 0 00 25 ppm 75 ppm 75 ppm Female Male Female 39 35 50 28 50 50 50 50 50 32 50 50 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 (1) Multiple Aberrations - a heavily damaged cell containing aberrations too numerous to count. (2) Miscellaneous - a cell containing pulverizations, endoreduplications, etc. (3) Chromatid Aberrations - includes breaks with fragments, breaks without fragments, intrachanges, and interchanges. (4) Chromosome Aberrations - includes breaks with fragments, breaks without fragments, dicentrics, rings, translocations, and inversions. (5) Abnormal Cells - scored as one if a cell contained any of the abnormalities listed in notes (1), (2), (3), or (4). (6) A single male rat from the 25 ppm group designated for cytogenetic evaluation died spontaneously prior to the time of evaluation. SL 082328 TABLE 12 Exposure Level (ppm) 0 10 40 Time N 30 days 30 days 30 days 4 4 4 VINYUDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Summary of Organ Weights and Organ to Body Weight Ratios for Male Rats Body Weight (g) 373.5+19.0 3B7.034.0 408.0+12.0 Brain 9 q/100q 1,820.12 1.84+0.03 1.85+0.04 0.49+0.01 0.48+0.04 0.45+0.02 Heart 9 q/lOOq 1.20+0.16 1.13+0.05 1.26+0.15 0.32+0.03 0.29+0.01 0.31+0.03 Liver 9 q/lOOq 11.15+0.57 11.26+1.62 12.34+0.63 2.99+0.14 2.90+0.19 3.03 + 0.10 Kidney 9 q/100q Testes 9 g/lOOq 2.71+0.16 2.76+0.29 2.93+0.12 0.72+0.03 0.72+0.05 0.72+0.05 3.68+0.27 3.76+0.24 3.55+0.19 0.98+0.06 0.98+0.04 0.87+0.04* 0 6 months 5 553.4+41.7 1.83+0.10 0.33+0.04 1.52+0.14 0.28+0.02 15.22+3.56 2.73+0.42 3.77+0.51 0.68+0.06 3.88+0.30 0.71+0.10 25 6 months 5 521.6+29.1 1.94+0.07 0.37+0.03 1.40*0.11 0.27+0.02 13.81+1.86 2.64+0.22 3.63+0.36 0.70+0.03 3.85+0.10 0.74+0.04 75 6 months 5 519.6+0.48 1.96+0.05* 0.38+0.03 1.49+0.09 0.29+0.01 13.23+1.63 2.54+0.18 3.57+0.52 0.69+0.06 3.90+0.36 0.75+0.09 0 1 year 5 660.4+44.3 1.98+0.08 0.30+0.01 1.68+0.16 0.26+0.02 20.57+1.51 3.13+0.34 4.39+0.51 0.67+0.12 4.08+0.30 0.62+0.03 25 1 year 5 575.9+48.3* 1.97+0.08 0.35+0.04 1.58+0.04 0.28+0.02 15.28+2.10* 2.65+0.23* 3.94+0.39 0.69+0.06 4.04+0.23 0.71+0.10 75 1 year 5 562.8+41.4* 1.930.03 0.34+0.03 1.54+0.11 0.27+0.02 15.13+2.06* 2.69+0.29 4.04+0.51 0.72+0.09 3.88+0.19 0.69+0.08 0 2 years 13 52778 25 2 years 13 495+85 75 2 years 8 492+61 1.94+0.11 1.99+0.11 1.970.06 0.38+0.07 0.41+0.07 0.41+0.05 1.88+0.18 1.88+0.30 1.84+0.20 0.36+0.05 0.39+0.08 0.38+0.03 18.28+1.95 16.92+2.94 16,96+2.54 3.50+0.37 3.44+0.41 3.44+0.24 5.85+1.08 5.33+0.93 5.41+0.78 1.14+0.30 1.10+0.24 1.11 + 0.16 4.22+0.81 3.56+0.68 4.14+0.45 0.82+0.16 0.73+0.14 0.85+0.09 `Significantly different from control group by Analysis of Variance and Dunnett's test, p<0.05. i UJ ilO SL 082329 Exposure Level (ppm) 0 10 40 0 25 75 0 25 75 0 25 75 TABLE 13 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY ANO ONCOGENIC STUOY IN RATS Summary of Organ Weights and Organ to Body Weight Ratios for Female Rats Time 30 days 30 days 30 days N 4 4 4 6 months 6 months 6 months 5 5 5 1 year 1 year 1 year 5 5 5 2 years 2 years 2 years 21 13 16 Body Weight (g) 251.0+20.0 249.0+3.0 236.021.0 327.0+14.5 303.2+49.9 326.6H7.2 329.0+18.7 365.626.0 339.638.3 402-95 418+109 404+72 Brain 9 g/lOOq 1.7310.06 1.75+0.04 1.74+0.05 0.69+0.06 0.70+0.02 0.7410.05 Heart 9 g/lOOq 0.81+0.02 0.83+0.07 0.7510.07 0.32+0.02 0.3310.03 0.3210.01 Liver 9 q/lOOq 6.45+0.33 6.4B-0.30 5.87+0.45 2.58+0.09 2.60*0.12 2.49*0.11 Kidney 9 9/100q 1.70+0.22 1,8b-0.08 1.68+0.16 0.68+0.06 0.75-0.02 0.71+0.01 1.8110.02 1.81+0.05 1.83+0.05 0.55+0.03 0.61+0.10 0.56+0.04 0.58+0.0/ 0.92+0.16 0.95+0.04 0.30+0.02 0.30+0.01 0.29+0.01 7.25+1.15 b.94 + 1.27 7.47+0.77 2.22-0.35 2.29+0.20 2.28+0.14 2.03+0.28 1.88-0.31 2.06-0.14 0.62-0.09 0.62-0.05 0.63+0.05 1.82+0.06 1.82+0.09 1.7710.06 0.55+0.04 0.5010.04 0.53+0.06 1.03+0.09 1.09+0.11 1.0810.01 0.3U0.02 0.3010.04 0.3210.03 7.45+0.69 8.39+1.51 9.0410.80 2.26+0.11 2.32+0.55 2.67+0.21 2.09+0.10 0.63-0.03 2.44 + 0.2b* 0.67+0.11 2.60+0.18* 0.77+0.09 1.7910.06 1.77+0.06 1.76+0.07 0.47+0.11 0.45+0.09 0.4510.08 1.24+0.15 1.29+0.20 1.2710.15 0.32+0.09 0.33+0.09 0.32+0.08 13.47+4.17 13.59+3.77 13.99+4.39 3.37+0.76 3.26+0.51 3.47+0.90 2.94+0.49 2.96-0.63 3.10+0.55 0.77-0.23 0.75-0.24 0.80-0.26 Significantly different from control group by Analysis of Variance and Dunnett's test, p<0.05. SL 082330 -41- TABLE 14 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 IS 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 LIVER Enlarged or congested with or without secondary darkening H-01 Control 25 ppm 75 ppm Atrophied (decrease in si2e) H-02 Control 25 ppm 75 ppm Small white or pale-colored foci H-03 Control 25 ppm 75 ppm Red subcapsular foci H-04 Control 25 ppm 75 ppm Roughened due to chronic passive congestion H-06 Control 25 ppm 75 ppm Dark and discolored H-07 Control 25 pnm 75 ppm Fluid-filled cysts H-08 Control 25 ppm 75 ppm Accentuation of lobular pattern H-ll Control 25 ppm 75 ppm Palish discoloration H-12 Strangulation, folding or other distortion, of a loba H-14 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Mottled H-15 Control 25 ppm 75 ppm RESPIRATORY SYSTEM Thoracic Cavitv Hemothorax K-07 Control 25 ppm 75 ppm Hydrothorax K-04 Control 25 ppm 75 ppm Thoracic cavity pleuritis K-17 Control 25 ppm 75 ppm 02 20 00 10 00 00 00 00 00 00 00 00 00 00 0 0 00 00 00 00 00 00 00 00 00 02 00 00 00 00 00 00 00 00 00 00 10 00 00 00 00 10 00 58 2 10 54 03 13 03 07 02 17 25 01 03 01 00 03 00 00 01 02 01 01 2 11 15 03 01 11 24 01 00 00 00 03 01 01 00 01 17 0 10 0 11 00 00 00 0 15 1 15 09 04 15 03 18 13 5 13 29 1 2* 03 01 00 03 00 00 01 13 01 01 1 14 1 1 4a 03 24 -0 6 0i 00 00 00 03 01 01 00 02 08 2 12 0 11 00 01 00 3Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0 -- SL 082331 -42- table 14 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nonttimorous Gross Pathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 Thoracic Cavity (nont'd) Pleural adhesions K-Gl Fibrinous exudate with fluid K-03 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Control 0 0 0 25 ppm 1 0 0 75 ppm 0 0 0 Lungs Atelectasis (edematous) K-05 Control 0 0 0 25 ppm 0 0 1 75 ppm 0 0 1 Pneumonia K-9 Control 1 0 1 25 ppm 2 0 5 75 ppm 0 0 4 Golden brown pigment K-10 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Consolidation K-06 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Small red foci K-Q2 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Bronchiectasis K-12 Control 0 0 1 25 ppm 0 0 1 75 ppm 0 0 2 Mineralization K-13 Control 0 0 1 25 ppm 0 0 0 75 ppm 0 0 2 Diffuse darkened areas throughout lung Control 0 0 5 K-14 25 ppm 0 0 1 75 ppm 1 0 6 Small pale subpleural foci K-15 Control 0 0 0 25 ppm 0 0 1 75 ppm 0 0 0 Congestion with or without edema Control 0 0 0 K-16 25 ppm 0 0 0 75 ppm 0 0 0 L9-24 Months kb 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 202 101 000 101 001 000 707 11 0 12 9 0 10 0 0A 17 3 13 1 18 112 101 000 000 101 101 101 10 527 00 9 0 10a 9 0 11 00 1 000 10 3 8 0 13 32 6 4 0 ii 325 315 606 303 202 20 2 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.CS. SL 082332 -43- TABLE 14 (Continued) VINYUDENE CHLORIDE: A CHRONIC INHALATTON TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions m Male Rats Number of rats necropsled during the time period indicated Control 25 ppm 75 ppm 0--6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 URINARY SYSTEM Urinary Bladder Petechial hemorrhage or mucosal hyper-- Control 0 0 1 etnia 25 ppm 0 0 0 IE-28 6 IE-16 75 ppm 0 0 0 Thickened wall or changes suggestive Control 0 0 0 of cystitis 25 ppm 0 0 0 IE-22 & IE-17 75 ppm 0 0 0 Distention with urethral obstruction Control 0 1 5 IE-19 25 ppm 0 0 0 75 ppm 0 0 2 Urinary calculi IE-20 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Hematuria - blood in urinary bladder Control 0 1 0 IE-33 Z5 ppm 0 1 0 75 ppm 0 0 0 Kidney Chronic renal disease with or without Control 0 0 4 cytt formation, minimal 25 ppm 0 0 7 I-02-L 75 ppm 0 0 8 Chronic renal disease, moderate Control 0 0 0 I-02-M 25 ppm 0 0 0 75 ppm 0 0 0 Chronic renal disease, severe I-02-S Control 0 0 4 25 ppm 0 1 2 75 ppm 0 0 2 Increased in size not directly assocl- Control 0 1 1 ated with chronic renal disease 25 ppm 0 0 0 1-01 75 ppm 0 0 0 Enlarged and Congested 1-03 Control 0 0 1 25 ppm 0 0 0 75 ppm 0 0 1 Dilated renal pelvis 1-04 Control 0 0 1 25 ppm 0 0 0 75 ppm 0 0 0 Mineralization or granular debris Control 0 0 0 within renal pelvis 25 ppm 0 0 0 1-05 4 1-07 75 ppm 0 0 0 Hydronephrosis 1-06 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 102 0 11 101 000 112 000 107 112 204 101 011 000 001 001 000 21 10 35 23 4 34 23 4 35 101 112 112 12 0 16 11 1 15 14 0 16 002 101 000 102 303 203 326 10i 0 0 o1 303 000 000 101 000 Cl 0 0 aSigniflcantly different from control data when analyzed using Fisher's Exact Probability Test , p<0.05. SL 082333 -44- table 14 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross pathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0--6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 Kidney (cont'd) Renal failure - probable cause of death Control 0 0 3 or poor condition 25 ppm 0 1 2 1-13 75 ppm 0 0 2 Infarct, local P-11 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 White foci 1-14 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Decrease in size 1-15 Control 1 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Dark and discolored 1-09 Control 0 1 0 25 ppm 0 0 1 75 ppm 0 0 0 Pyelonephritis - inflammation of the Control 0 0 1 kidney and renal pelvis 25 ppm 0 0 0 1-20 75 ppm 0 0 0 CARDIOVASCULAR SYSTEM Heart Left atrial thrombosis L-02 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 1 Degeneration or dilated ventricles Control 0 0 1 (including flaccid ventricles) 25 ppm 0 0 0 L-93 4 L-04 75 ppm 0 0 2 Pale foci in muscle or generalized Control 0 0 0 paleness of muscle 25 ppm 0 0 0 L-01 75 ppm 0 0 0 Mineralization L-09 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Atrioventricular valve hematoma Control 0 0 0 L-12 25 ppm 0 0 0 75 ppm 0 0 0 Aorta Vessels - dilated and inelastic Control 0 0 4 L-06 25 ppm 0 0 0 75 ppm 0 0 1 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 11 0 14 5 2 10 13 0 15 000 101 0 00 0 00 000 101 001 000 0 00 001 001 000 102 000 000 5 05 909 708 8 2 11 527 608 3 0 2 000 30 3 000 000 101 0 00 000 101 15 1 20 8 19 9 0 10 aSignificantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05 SL 082334 -45- table 14 (Continued) V1NYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Cross Pathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0--6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 CARDIOVASCULAR SYSTEM (cont'd) Vessels Periarteritis, (vasculitis) sclerosis, Control 0 0 0 and other related changes including 25 ppm 0 0 1 thrombosis of a vessel 75 ppm 0 0 0 L-08 Nodular areas in mesenteric vessels Control 0 0 0 or mesentery - vascular in nature 25 ppm 0 0 0 P-05 75 ppm 0 0 0 ABDOMINAL CAVITY Intra-abdominal fluid or blood F-I3 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 ADIPOSE TISSUE Depleted or any decrease in quantity Control 1 0 3 D-01 25 ppm 1 0 2 75 ppm 0 0 2 Obese or excessive quantity including Control 0 3 5 "fat rat syndrome" 25 ppm 0 0 5 D-02 75 ppm 0 0 5 Strangulation of a portion of abdominal Control 0 0 0 fat 25 ppm 0 0 0 D-03 75 ppm 0 0 0 GASTROINTESTINAL TRACT AND INTRA-ABDOMINAL CAVITY Salivarv Gland Inflammation F-24 Control 0 0 1 25 ppm 0 0 0 75 ppm 0 0 0 Stomach Gastric ulcers, erosions or focal hem- Control D 0 4 orrhage 25 ppm 0 1 i F-05 & F-02 75 ppm 0 0 i Gastric mineralization F-03 Control 0 0 3 25 ppm 0 0 1 75 ppm 0 0 4 Gastric distention with air F-04 Control 0 0 2 25 ppm 0 0 2 75 ppm 0 0 2 Thickened gastric mucosa (hyperkerato- Control 0 0 1 sis) 25 ppm 0 0 0 F-26 75 ppm 0 0 0 Gastric edema F-37 Control 0 0 1 25 ppm 0 0 1 75 ppm 0 0 0 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 639 517 404 000 000 1Q 1 303 101 202 12 1 17 19 4 26 16 2 20 4 0 12 139 5 0 10 112 000 000 067 0 0 oa 134 8 2 14 13 3 18 14 0 15 12 0 15 4 0 5a 11 0 15 002 406 305 2 14 505 202 001 203 101 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.r SL 082335 -46- table 14 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Cross Pathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 GASTROINTESTINAL TRACT AND INTRA-ABDOMINAL CAVITY (cont'd) Intestinal Tract Decreased amount of ingesca or feces in Control the gastrointestinal tract 25 ppm F-07 75 ppm 2 0 0 Bloody fluid material or darkening of Control ingesta in gastrointestinal tract - 25 ppm associated with chronic renal disease 75 ppm F-29 Bloody fluid material or darkening of ingesta in gastrointestinal tract associated with malocclusion F-30 Control 25 ppm 75 ppm 0 0 0 1 0 0 Bloody fluid material or darkening of Control ingesta in gastrointestinal tract - 25 ppm associated with an undetermined cause 75 ppm F-33 Intestinal tract inspissation of fecal material F-39 Control 25 ppm 75 ppm 0 0 0 0 0 0 Large Intestine Parasites (pinworms) F-ll Control 25 ppm 75 ppm 0 1 0 Cecum hemorrhagic or edematous, thickened, whiteish discoloration, gelatinous material or inflamination indicative of uremic typhlitis F-18 4 F-25 Control 25 ppm 75 ppm 0 0 0 REPRODUCTIVE SYSTEM Testicles - enlarged or edematous IE-01 Control 25 ppm 75 ppm 0 0 0 Testicular atrophy (flaccid) - unilateral and bilateral IE-02 White foci in seminiferous tubules IE-13 Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0 0 0 0 0 0 White foci on testicle P-03 Control 25 ppm 75 ppm 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 1 0 1 1 1 1 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 4 3 3 0 0 0 0 1 0 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 10 0 15 9 2 12 309 506 203 3 04 002 000 000 101 000 001 000 011 000 0 00 102 101 3 14 000 203 011 000 000 13 4 21 14 2 19 15 0 18 134 202 i01 000 001 101 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082336 -47- TABLE 14 (Continued) VINYL1DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 06 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 REPRODUCTIVE SYSTEM (cont'd) Testes and/or accessory sex glands - Control 0 0 0 congestion 25 ppm 0 0 0 IE-26 75 ppm 0 0 0 Testes - rudimentary structure with Control 0 0 0 small epididymis 25 ppm 0 0 0 IE-27 75 ppm 0 0 0 Cryptorchidism, bilateral or unilateral Control 0 0 0 IE-31 25 ppm 0 0 0 75 ppm 0 0 0 Accessory sex gland atrophy IE-06 Control 0 0 1 25 ppm 0 0 0 75 ppm 0 0 1 Accessory sex gland - enlarged and in* Control 0 0 2 flamed 25 ppm 0 0 0 IE-07 75 ppm 0 0 0 Accessory sex glands impacted with Control 0 Q 0 secretory material 25 ppm 0 0 0 IE-21 75 ppm 0 0 0 Epididymal fat pad edema, hyperemia or Control 0 0 0 congestion 25 ppm 0 0 0 IE-08 75 ppm 0 0 1 Epididymal fat pad - focal necrosis Control 0 0 0 IE-30 6 IE-24 25 ppm 0 0 0 75 ppm 0 0 0 Epididymis - focal enlargement IE-04 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Prostate gland enlarged IE-10 4 IE-15 Control 0 0 1 25 ppm 0 0 0 75 ppm 0 0 0 Abscessed preputial glands IE-09 Control 0 0 1 25 ppm 0 0 0 75 ppm 0 0 0 NERVOUS SYSTEM Pituitary Hemorrhagic foci N-06 Control 0 0 1 25 ppm 0 0 0 75 ppm 0 0 0 Red foci with focal enlargement Control 0 0 0 N-09 25 ppm 0 0 1 75 ppm 0 0 0 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 1 01 0 00 0 00 101 0 11 0 00 0 11 011 000 809 718 708 002 101 303 101 0 00 000 0 00 000 001 0 00 0 00 202 0 00 101 101 203 202 202 203 1 01 0 00 0 12 1 01 0 00 000 1 02 101 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082337 -48- TABLE 14 (Continued) VINYIIDENE CHLORIDE; A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions in Male Rats Number o rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-13 Months 19 18 19 NERVOUS SYSTEM (cont'd) Brain Malacia of brain N-07 Control 0 0 0 25 ppm 0 1 1 75 ppm 0 1 0 Focal compression of the base of the Control 0 0 0 brain as a result of an enlarged 25 ppm 0 0 0 pituitary 75 ppm 0 0 0 N-ll ENDOCRINE SYSTEM Thyroid - white foci 0-04 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Parathyroid - hyperplasia 0-02 Control 0 0 5 25 ppm 0 0 1 75 ppm 0 0 6 ADRENAL GLAND Hemorrhagic appearance on cross section Control 0 0 0 J-04 25 ppm 0 0 0 75 ppm 0 0 1 Mottled appearance J-05 Control 0 Q 0 25 ppm 0 1 0 75 ppm 0 0 0 Decrease in size J-06 4 J-07 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 INTEGUMENTARY SYSTEM Keratinized e-. rermal inclusion cyst Control 0 0 0 B-01 25 ppm 0 0 0 75 ppm 0 0 0 Acute inflammation of a limb/body Control 0 0 0 Number per rat 1 25 ppm 0 0 0 B-06 75 ppm 0 0 0 MUSCULOSKELETAL SYSTEM Skeletal demineralization M-01 Control 0 0 2 25 ppm 0 0 0 75 ppm 0 0 0 Ankylosis of a Joint M-05 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 Muscular atrophy M-G6 Control 0 0 0 25 ppm 0 0 0 75 ppm 0 0 0 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 000 002 001 1 01 0 00 0 00 101 000 000 15 0 20a 7 2 10* 12 0 18 1 12 101 102 606 506 202 011 011 112 I12 000 20 2 10 1 000 000 507 303 7 07 1 34 1 10 0 00 0 33 033 000 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0. 05. SL 082338- -49- TABLE 14 (Continued) V1NYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND oncogenicity study in rats Nontumorous Gross Pathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm LYMPHORETICULAR SYSTEM Lymph node(s) - swollen and/or con- Control gested, edematous - local, containing 25 ppm hematogenous pigment or cystic 75 ppm G-01 Lymph node(s) - swollen and congested. Control edematous - general, containing hema- 25 ppm togenous pigment or cystic 75 ppm G-02 Splenomegaly - extramedullary hematopolesis (no indication of tumorous process) G-06 Control 25 ppm 75 ppm Splenic atrophy (decrease in size) G-08 & G-Q9 Control Z 5 ppm 75 ppm EYE Corneal opacity - unilateral C-04 Control 25 ppm 75 ppm Corneal opacity - bilateral C-04 Control 25 ppm 75 ppm Corneal dryness C-07 Control 25 ppm 75 ppm Hyperemia C-09 Control 25 ppm 75 ppm GENERAL Postmortem change, minimal A-02-L Postmortem change, moderate A-02-M Control 25 ppm 75 ppm Control 25 ppm 75 ppm Postmortem change, severe A-02-S Cannibalism A-03 Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Rill Results 13 86 13 85 8 86 001 2 25 001 3 26 000 5 05 000 2 13 001124 0 0 0 0 00 01000 1 001 102 001 3 04 000 101 0000 00 000 000 0010 34 00100i 000 112 0 0 1 6 3 10 0 0 1 5 11 17 0 0 0 9 4 13 000 i01 000000 000000 000101 000000 000 101 0005 05 101305 001102 0 1 4 6 0 11 0 0 2 10 0 12 1 1 4 5 0 11 1 0 3 7 0 11 202004 10 i 3 05 024 309 1 0 0 1 0 23 2 1 5 2 0 10 aSigniicantly different from control data when analyzed using Fisher1' s Exact Probability Test, p<0. 05. SL 082339 -50- TABLE 14 (Continued) VINYLIDENE CHLORIDE: A CHROMIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Cross Pathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm GENERAL (cont'd) Emaciation - decrease in body condition Control A-04 25 ppm 75 ppm Anemia A-06 Control 25 ppm 75 ppm Nasal or ocular exudate A-07 Control 25 ppm 75 ppm Nasal hemorrhage A-08 Control 25 ppm 75 ppm Malocclusion A-09 Control 25 ppm 75 ppm Ulceracion of hard palace, congue, or opposing gingival surface with or without inflammation A-10 Control 25 ppm 75 ppm Ulcerated skin lesion A-12 Control 25 ppm 75 ppm Loss of hair (focal alopecia) A-13 Control 25 ppm 75 ppm Perineal fecal material secondary to chronic renal disease, malocclusion. and other cause A-14 Control 25 ppm 75 ppm Broun pigmented (porphyrin) material in facial area and/or foreliabs A-17 Control 25 ppm 75 ppm Edema of all or some of the tissues of the body A-18 Control 25 ppm 75 ppm 0-6 Months a 4 4 7-12 Months 5 a 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 2 0 4 5 1 12 0 0 1 11 4 16 010719 001203 0 0 0 0 00 001203 0011 0 2 1 0 1 6 0 * 8a 1 0 7 4 0 12a 000i01 000000 000000 205 108 1003 15 0013 15 204006 100 2 03 001304 000000 000000 000 2 0 2 000000 1000 01 00 00 00 0 0 4 7 0 11 0 0 0 2 1 3a 00 0 5 0 5 000101 002 103 000404 00010i 00100i 000 10 1 aSignificantly different from control data when analyzed using Fisher1 s Exact Probability Test* p<Q. 05. si 82 -51- TABLE 15 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Male Rats Number of race necropsied during the rime period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 LIVER Accentuated hepatic lobular pattern due to centnlobular atrophy H-01 Control 25 ppm 75 ppm Generalized hepatic lobular atrophy H-02 Control 25 ppm 75 ppm Accentuated hepatic lobular pattern due to centrilobular atrophy with hepatocellular vacuolization H-03 Control 25 ppm 75 ppm Foci of intralobular hepatocellular alteration H-04 Control 25 ppm 7 5 ppm Area of intralobular hepatocellular alteration H-05 Control 25 ppm 75 ppm Focal hepatic necrosis H-06 Control 25 ppm 75 ppm Multifocal hepatic necrosis H-07 Control 25 ppm 75 ppm Generalized centrilobular degeneration and/or necrosis (anoxic) with or without associated accentuation of the lobular pattern or associated fatty change H-08 Control 25 ppm 75 ppm Focal biliary hyperplasia H-09 Control 25 ppm 75 ppm Focal periportal fibrosia H-10 Control 25 ppm 75 ppm Focal biliary cyst formation H-ll Control 25 ppm 75 ppm Focal mononuclear cell infiltrate H-12 Control 25 ppm 75 ppm Focal extramedullary hematopoiesis H-13 Control 25 ppm 75 ppm 1 1 0 1 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 2 1 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 4 17 8 30 0 5 21 7 34 2 4 19 7 32 0 6 15 1 23 0 2 13 1 17. 1 3 9 0 13* 22 217 02 305 05 107 0016 7 00 0 6 6 00134 00000 00000 00 0 1 1 0 1 00 1 01 203 00 000 0 2 2 04 00 314 00 1 12 2 4 5 0 11 1 4 9 0 16 0 4 10 0 15 0 2 8 10 20 0 2 4 4 10a 0 2 5 0 7* 0 3 10 9 22 0 1 7 5 13. 0 2 7 1 10* 00 5 2 7 00 325 00202 4 15 36 13 68 2 8 28 12 50* 3 13 26 4 48* 10 10 2 01405 10 i02 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082341 -52- table 15 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Monchs 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 LIVER (cont'd) Focal vascular ectasia (dilatation) H-14 Control 25 ppm 7 5 ppm Minimal hepatocellular fatty change H-22 Control 25 ppm 75 ppm Moderate hepatocellular fatty change (centrllobular and/or midzonal) H-23 Control 25 ppm 75 ppm Severe hepatocellular fatty change H-24 Control 25 ppm 75 ppm Increased number of reticuloendothelial Control cells lining sinusoids (reciculo- 25 ppm endothelial hyperplasia) 75 ppm H-27 Foci of cystic degeneration of hepatocytes H-28 Control 25 ppm 75 ppm RESPIRATORY SYSTEM Trachea Focal subepithelial lymphoid infiltrate Control R-Ol 25 ppm 75 ppm Chronic or acute tracheitis R-03 Control 25 ppm 75 ppm Lungs Chronic pulmonary lesions characterized Control by edema, interstitial thickening and 25 ppm fibrosis. Inflammatory cell infil- 75 ppm crate and exudation of cells into the alveoli, with ot without atelectasis (associated with advanced cardiac or renal lesions) R-20 A R-38 Focal alveolar histiocytosis R-22 Control 25 ppm 75 ppm Peribronchial lymphoid cellular infil trate R-23 Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 1 0 0 0 2 0 0 0 2 2 00325 00202 0 0 3 14 02327 001 12 0 3 6 3 12 000 11 0 0 1 01 0 1 0 01 00101 00000 00101 00 101 00000 00101 00022 0 0 1 34 00022 05 60 00314 01405 0 1 0 0 1. 0 4 16 2 K 0 3 15 2 21* 1 3 19 0 23 0 0 11 1 12 0 0 15 0 15 2 8 21 10 43 2 4 17 10 33 3 3 14 3 23' 5 17 27 13 62 3 13 18 11 47' 4 16 21 6 49' Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. Sli o82342 -53- table 15 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 Lungs (cont'd) Focal interstitial pneumonitis R-24 Control i 0 0 2 4 6 25 ppm 0 0 0 1 3 4 75 ppm 0 0 0 4 1 5 Focal aggregates of macrophages con- Control 0 0 0 i 5 6 taining hematogenous pigment within 25 ppm 0 0 1 i 4 6 the alveoli 75 ppm 0 0 0 0 i i R-25 Acute diffuse suppurative pneumonia Control 1 0 0 0 0 i R-28 25 ppm 2 0 0 0 0 2 75 ppm 2 0 1 0 0 3 Focal granulomatous inflammation Control 0 0 0 1 0 1 R-30 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Fleuritis R-31 Control 0 0 1 0 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Focal pulmonary abscess formation Control 0 0 1 0 0 1 R-32 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Focal mineralization of the intra- Control 0 0 5 9 0 14 alveolar septae 25 ppm 0 0 1 3 0 4a R-33 75 ppm 0 0 3 6 0 9 Chronic murine pneumonia R-3S Control 0 0 0 0 04 25 ppm 0 0 4 19 3 75 ppm 0 0 3 19 2 24* Cholesterol cleft formation R-41 Control 0 0 0 0 1 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 URINARY SYSTEH Kidney Minimal degree of chronic nephropathy Control 2 4 4 5 0 15 U-01 25 ppm 0 2 7 7 1 17 75 ppm 0 4 3 7 0 14 Moderate degree of chronic nephropathy Control 0 1 7 9 6 23 U-02 25 ppm 0 0 5 11 5 21 75 ppm 0 0 6 16 5 27 Severe degree of chronic nephropathy Control 0 0 1 19 7 27 U-03 25 ppm 0 0 4 15 7 26 75 ppm 0 0 4 20 3 27 End stage kidney U-04 Control 0 0 7 12 0 19 25 ppm 0 1 2 14 0 17 75 ppm 0 0 6 8 0 14 Significantly different from control data when analyzed using Fisher'1 s Exact Probability Test, p<0,.05. SL 082343 -54- table 15 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous HistODathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 k 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months i*6 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 Kidnev (cont'd) Mineralized deposits withinkidney tubules, focal U-05 Control 25 ppm 75 ppm Focal renal cortical tubular hyperplasia U-09 Control 25 ppm 75 ppm Acquired hydronephrosis U-18 Control 25 ppm 75 ppm Pyelonephritis U-19 Control 25 ppm 75 ppm Focal hyperplasia of the transitional epithelium U-21 Control 25 ppm 75 ppm Urogenital Tract Chronic urocystltis U-40 Control 25 ppm 75 ppm Focal hyperplasia of urinary bladder mucosa U-42 Control 25 ppm 75 ppm Diffuse hyperplasia of urinary bladder mucosa U-43 Control 25 ppm 75 ppm Focal squamous metaplasia U-46 Control 25 ppm 75 ppm GASTROINTESTINAL SYSTEM Stomach Focal gastric ulceration and/or hemorrhage G-01 Control 25 ppm 75 ppm Mineralization of stomach and/or gastric mucosa G-02 S, G-04 Control 25 ppm 75 ppm Hyperplasia of gastric nonglandular epithelium G-03 Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 13 0 90 60 00 00 00 00 10 00 10 11 00 01 00 00 17 10 9 1 0 0 1 1 0 2 2 0 1 0 0 6 06 1 12 2 02 2 02 Oil 0 00 1 01 0 00 0 00 0 00 Oil 0 00 4 15 50 5 3 14 15 0 20 9 0 11 11 0 15 20 20 10 2 2 1 Not significantly different from control tjata when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082344 -55- TABLE 15 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm Stomach (cont'd) Focal erosion of gastric mucosa G-05 Control 25 ppm 75 ppm Gastric edema of nonglandular portion G-06 Small Intestine Focal lymphoid hyperplasia G-42 Large Intestine Intestinal neoatodiasis G-50 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Focal areas of chronic inflammation and/or ulceration with or without necrosis G-53 Control 25 ppm 75 ppm Cecum Edema in the submucosa G-60 Control 25 ppm 75 ppm Typhlitis G-61 Control 25 ppm 75 ppm Salivary Gland Chronic interstitial sialoadenitis G-71 Control 25 ppm 75 ppm Pancreas Focal atrophy of pancreatic acinar tissue P-03 Control 25 ppm 75 ppm Focal interstitial pancreatitis P-05 Control 25 ppm 75 ppm Focal interstitial inflammation and fibrosis P-07 Control 25 ppm 75 ppm Pancreatic islet cell hyperplasia P-22 Control 25 ppm 75 ppm 0-6 Months 3 4 4 7*12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 000i12 000202 0 0 00 00 000202 000000 000202 000011 000000 000000 0010 45 000 1 0 1 00 1 4 4 9 000 2 02 00 0 0 00 000000 000101 000000 000000 000101 0 0 0 0 00 000000 001102 000000 000000 1 0 4 12 9 26 002125 0 0 4 11 4 19 0 0 2 12 9 23 002125 0 0 4 11 4 19 0 000 00 0 0 00 00 000101 0 0 00 00 0 0 0 0 00 000011 Not significantly different from control data when analyzed using Fisher 's Exact Probability Test, p<0.05. SL 082345 -56- TACLE 15 (Continued) VINYLIDENE CHLORIDE:. A CHRONIC INHALATION TOXICITY ANTI ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Rill Results 13 86 13 85 8 86 CARDIOVASCULAR SYSTEM Heart Minimal degree of focal myocardialdegeneration and fibrosis C-01 Control 25 ppm 75 ppm 12 6 15 0 0 11 27 0 0 10 19 9 33 8 46* 4 33 Moderate degree of focal myocardial degeneration and fibrosis C-02 Control 25 ppm 75 ppm Severe degree of focal myocardial degeneration and fibrosis C-03 Control 25 ppm 75 ppm Thrombosis formation in atrium or ventricle C-04 Control 25 ppm 75 ppm 0 17 17 0 13 16 00 4 24 0 0 4 13 00 13 00 25 10 07 00 04 00 05 4 29 4 24 3 31 0 1 1 17 5 a a a 08 04 05 Mineralization of myocardium C-09 Control 0 0 2 6 0 8 25 ppm 0o 25 07 75 ppm 0 0 1 4 0 5 Focal areas of necrosis andinflamma- Control 0 0 10 0 1 tion in ventricle C-10 25 ppm 75 ppm 00 0000 00 0000 Endocardial fibroelastosis Oil Control 0 0 0 0 0 0 25 ppm 0 0 0 10 1 75 ppm 0 0 2 0 0 2 Aorta Aortic mineralization C-25 Control 0 0 25 ppm 00 75 ppm 0 0 6 20 15 6 13 2 28 28 1 20 Blood Vessels Periarteritis and sclerosis ofmesen- Control 0 0 teric blood vessels and other sc- 25 ppm 00 lected blood vessels 75 ppm 00 C-41 1 10 22 58 3 14 15 1 14 0 0Hyalinization, sclerosis and/or fibrin- Control 2 3 8 13 old degeneration of mesenteric and 25 ppm 01 020 3a other blood vessels consistent with 75 ppm 00 12 14* varying degrees of mesenteric peri arteritis C-43 Mineralization of mesenteric blood vessels and other selected blood vessels Control 25 ppm 75 ppm 0 0 0 0 0 0 3 15 00 13 0 18 0 0 0, a C-44 Thrombi in peripheral blood vessel Control 0 0 0 10 1 C-47 25 ppm 000000 75 ppm 0 0 0 0 0 0 Significantly different from control data when analyzed using Fisher's Exact Probability Tost, p<0.05. SL 082346 -57- TABLE 15 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm reproductive system Testes Testicular atrophy X-Q2 Control 25 ppm 75 ppm Mineralization of atrophic seminiferous Control tubules 25 ppm X-04 75 ppm Hy&linization, sclerosis and/or fibrin- Control old degeneration of testicular ves- 25 ppm sels consistent with varying degrees 75 ppm of periarteritis X-05 1 X-03 Sperm granuloma of the testis X-07 Control 25 ppm 75 ppm Interstitial cell hyperplasia X-12 Control 25 pom 75 ppm Focal mesothelial hyperplasia X-13 Epididvmis Atrophy X-30 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Spermatocele with chronic inflammation X-31 Control 25 ppm 75 ppm Accessory Sex Glands Atrophy X-35 Control 25 ppm 75 ppm Inflammation with or without edema X-36 Abscess of preputial gland X-39 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Prostate Gland Inflammatory reaction within prostate X-50 Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-13 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Rill Results 13 86 13 85 8 86 0 0 6 30 11 47 000 167 0 0 7 27 5 39 0 000 00 000011 0001 12 0 0 4 12 11 37 000156 0 0 4 22 5 31 00 00 00 0 00 101 000000 0000 00 00 00 00 000011 000000 0 000 0 0 000101 0 Q 1 12 2 15 000134 0 0 3 19 0 22 00 1001 000000 000000 000101 00000Q 00 0 0 00 00 3 1 04 0 0 0 1 0 --1 000 1 01 00 2 0 02 000 101 0 000 00 0 0 4 7 2 13 0002 13 0 003 14 Not significantly different from control data when analyzed using Fisher rs Exact Probability Test, p<0.05. SL 082347 58- TABLE 15 (Continued) VINYLIDENE CHLORIDE.' A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 Prostate Gland (cont'd) Focal hyperplasia X-53 Control 25 ppm 75 ppm NERVOUS SYSTEM Brain Uretnic encephalopathy - focal malacia N-14 Focal malacia with reactive gliosis and vascular thrombosis N-16 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Spinal Cord Vacuolization of myelin of spinal cord N-18 Control 25 ppm 75 ppm Peripheral Nerves Vacuolization of myelin within peripheral nerves N-32 Control 25 ppm 75 ppm Pituitary Sinusoidal dilatation within pituitary N-45 Control 25 ppm 75 ppm Hyperplasia N-50 Control 25 ppm 75 ppm Thrombosed vessel of pineal gland N-60 Control 25 ppm 75 ppm ADRENAL GLAND General Heaatocyst formation within adrenals A-02 Control 25 ppm 75 ppm Infarcted adrenal gland A-04 Atrophy A-Q5 Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 .1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 2 2 0000 0011 0 D00 1 214 0 102 0000 0000 00 01 1 17 12 30 0 1 45 1 17 8 26 1 24 11 36 0167 2 21 7 30 10 1 2 0000 0000 02 13 003 3 0213 0 10 1 0000 0000 0606 04 15 2406 0 101 0 000 0 000 0 101 0000 0 000 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05* SL 082348 -59- table 15 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 35 8 86 ADRENAL GLAND (cont'd) Cortex Mineralization A-23 Control 0 Q 1 1 0 2 25 ppm 0 0 0 0 0 0 75 ppm 0 0 1 0 0 1 Hyperplastic focus A-24 Control 0 0 4 10 3 17 25 ppm 0 0 1 7 3 ^a 75 ppm 0 0 3 5 0 8 Foci of lipomatosis A-27 Control 1 2 4 16 6 29 25 ppm 0 0 6 13 4 23 75 ppm 0 0 2 21 3 26 Necrosis associated with Ischemia Control 0 0 0 0 0 0 A-30 25 ppm 0 1 0 0 0 1 75 ppm 0 0 0 0 0 0 Medulla hyperplastic focus A-46 Control 0 0 1 5 1 h 25 ppm 0 0 0 1 0 1 75 ppm 0 0 1 3 0 4 THYROID AND PARATHYROID Thyroid Hyperplastic focus T-05 Control 0 0 0 1 1 2 25 ppm 0 0 1 3 1 5 75 ppm 0 0 0 5 1 6 Keratinized cyst or cystic debris Control 0 0 1 0 0 i within lumen 25 ppm 0 0 0 1 0 1 T-06 75 ppm 0 0 1 1 0 2 Keratinized duct T-12 Control 0 0 0 0 0 0 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 Parathyroid Hyperplasia T-20 Control 0 0 4 28 9 *1. 25 ppm 0 1 4 20 6 31 75 ppm 0 0 9 24 2 35 Hyperplasia based on gross examination Control 0 0 0 0 0 0 but microscopic section not available 25 ppm 0 0 0 0 0 0 for evaluation 75 ppm 0 0 1 0 0 1 T-28 SUBCUTANEOUS TISSUES, MAMMARY GLAND, AND INTEGUMENT Mammarv Gland Mammary gland hyperplasia S-30 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0,Q5. SL 082349 -60- TABLE 15 (Continued) VITvTLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS N'ontumorous Histopathologic Lesions in Male Rats Number of rats necropsied during Che time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 36 SUBCUTANEOUS TISSUES. MAMMARY GLAND. AND INTEGUMENT (cont'd) Integument Epidermal inclusion cyst S-50 Control 25 ppm 75 ppm 0 D 0 Focal ulcerative dermatitis and chronic Control inflammation 25 ppm S-58 75 ppm 0 0 0 MUSCULO-SKELETAL SYSTEM Atrophy of skeletal muscle with an Control occasional animal with focal mineral- 25 ppm ization 75 ppm M-01 1 0 0 Healed fracture M-02 Control 25 ppm 75 ppm 0 0 0 Chronic periarticular fibrosis of the hock M-1Q Control 25 ppm 75 ppm 0 0 0 ADIPOSE TISSUE Mediastinal or renal fat atrophy B-01 Focal necrosis with or without mineralizatiou B-03 Chronic inflammatory reaction B-04 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 EYE Chronic focal keratitis E-01 Degenerative changes of lens E-04 Panophthalmitis E-08 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0 0 0 0 0 1 0 0 0 lymphoreticular system Mediastinal Lymphoid Tissue Congestion and/or sinusoidal dilatation L-02 Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0213 010 1 0303 0000 0 000 0 101 4 20 12 37 016 2 13 7 22 0 00 0 001 1 0000 0101 0000 0000 9 30 02 4 28 02 01 10 00 00 01 4 43 13 1 34 13 01 01 00 00 01 3 12 01 2 25 45 00 55 01 00 00 1 16 45 1 28 09 00 0 11 01 00 00 1 9 0 10 00 1 1 0808 ^Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082350" -61 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm Mediastinal Lvmphoid Tissue (cont'd) Lymphoid hyperplasia, reactive secondary to chronic murine pneumonia L-04 Control 25 ppm 75 ppm Lymphadenitis L-06 Control 25 ppm 75 ppm Atrophy L-08 Control 25 ppm 75 ppm Lymphangiectasia 1-09 Control 25 ppm 75 ppm Mesenteric Lymph Nodes Congestion L-25 Control 25 ppm 75 ppm Sinusoidal dilatation L-26 Control 25 ppm 75 ppm Lymphoid hyperplasia L-27 Control 25 ppm 75 ppm Lymphangiectasis L-30 Control 25 ppm 75 ppm Focal lymphadenitis L-32 Control 25 ppm 75 ppm Mesenteric disease - cystic hemorrhagic Control lymph node 25 ppm 1-34 75 ppm Other Lymphoid Tissues Lymphoid hyperplasia L-35 Lymphadenitis L-36 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Spleen Atrophy of spleen with or without hemo- Control slderin pigment 25 ppm L-38 75 ppm 0-6 Months 3 u u 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 000 112 000 101 0 0 2 17 2 21a 000 000 000 000 2 0Q 0 02 004 105 00 0 1 01 0 0 0 0 00 0 000 1 1 000000 0 00000 000000 000011 0 0 00 00 000000 000011 000101 0000 22 001 1 02 0001 0 1 000 1 01 000000 000000 0010 0 1 000000 0000 00 000000 0001 01 000000 0 000 11 000000 0 00 3 03 0 00 1 01 0 00 0 00 0 000 00 1 0 8 23 0 32 1 0 0 11 1 13a 0 0 4 11 0 15a 3 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<Q.Q5. SL -62- TABLE 15 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions, in Male Rats Number of rate necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 36 13 85 8 86 Spleen (cont'd) Increased extramedullary hematopoiesis Control 0 1 1 7 0 9 L-40 25 ppm 0 0 3 11 1 15 75 ppm 0 1 1 12 0 14 Multiple foci of infarction 1-41 Control 0 0 1 0 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Reticuloendothelial cell hyperplasia Control 0 0 0 1 0 1 L-42 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082352 -63- table 16 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Tumor or Tumor-like Lesions Grossly Recognized in Male Rais Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 LIVER Tumor - primary H-09 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Tumor metastatic H-G9-M Control 0 0 0 0 0 0 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 1 1 Tumor, infiltrate and enlarged second- Control 0 0 0 1 0 1 ary tD generalized lymphoprolifera- 25 ppm 0 0 1 1 1 3 tive process 75 ppm 0 0 0 0 0 0 H-10 RESPIRATORY SYSTEM Focal nodule(a) K-08 Control 0 0 0 0 1 1 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 1 1 2 KIDNEYS Tumor - primary 1-10 Control 0 1 0 1 0 2 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 GASTROINTESTINAL TRACT AND INTRAABDOMINAL CAVITY Salivary Gland Salivary gland enlarged F-01 Control 0 0 0 0 3 3 25 ppm 0 0 0 0 1 1 75 ppm 0 0 0 0 1 1 Small Intestine Tumor or diverticulum F-08 Control 0 0 0 1 2 3 25 ppm 0 0 1 0 0 1 75 ppm 0 0 0 2 1 3 Large Intestine Tumor F-09 Control 0 0 0 0 0 0 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 0 0 0 Intraabdominal Cavltv Intraabdominal tumor in mesentery Control 0 0 0 0 0 0 (retroperltoneum) 25 ppm 0 0 0 0 0 0 F-15 75 ppm 0 0 0 1 0 1 Intraabdominal tumor - origin un- Control 0 0 0 0 0 0 certain 25 ppm 0 0 0 1 0 1 F-16 75 ppm 0 0 0 0 0 0 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082353 -64- TAxti.ii -'v VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Tumor or Tumor-like Lesions Crossly Recognised in Male Rats Number of rats necropsied during the time period Indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 GASTROINTESTINAL TRACT AND INTRAABDOMINAL CAVITY Pancreas Nodule(s) within F-19 Control 0 0 2 10 9 21 25 ppm 0 0 3 6 3 12 75 ppm 0 0 5 9 6 20 Omentum Nodule in omentum P-01 Control 0 0 0 0 0 0 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 REPRODUCTIVE SYSTEM Testicular tumor IE-03 Control 0 0 0 0 0 0 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 Tumor or cyst of pampiniform plexus Control 0 0 0 0 0 0 IE-32 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 0 0 0 NERVOUS SYSTEM Pituitary Increased in size or irregular in shape Control 0 0 3 8 1 12 with or without associated general- 25 ppm 0 0 0 3 1 4 ized color and consistency changes 75 ppm 0 1 2 2 0 5 N-02 Cranial Cavity Tumor within the cranial cavity Control 0 0 0 0 0 0 N-05 25 ppm 0 1 0 0 0 1 75 ppm 0 0 0 0 0 0 ENDOCRINE SYSTEM Thyroid Gland Increased in size 0-01 Control 0 0 0 6 4 10 25 ppm 0 0 0 2 1 75 ppm 0 0 0 3 0 3a ADRENAL GLAND Enlarged - unilateral and bilateral Control 0 0 0 5 2 7 with or without associated color 25 ppm 0 0 0 9 2 11 change 75 ppm 0 0 1 8 3 12 J-01 Tumorous enlargement J-02 Control 0 0 0 5 4 9 25 ppm 0 0 0 4 2 6 75 ppm 0 0 0 4 i 5 Significantly different from control data when analyzed using Fisher'1s Exact Probability lest, p<0 .05. SL 082354 -65- table 16 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Tumor or Tumor-like Lesions Grossly Recognized in Male Rats Number of rats necropsied during the time period Indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 MUSCULOSKELETAL SYSTEM Tumor of the skull and oral cavity Control 0 0 0 0 0 0 M-07 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 LYMPHORETICULAR SYSTEM Lymph node(s) - tumor consisting of Control 0 0 0 2 0 2 lymphoid tissue 25 ppm 0 , 0 0 0 0 0 G-03 75 ppm 0 0 0 0 0 0 Local invasion of tumor with regional Control 0 0 0 0 1 1 lymph node(s) involved 25 ppm 0 0 0 0 0 0 G-04 75 ppm 0 0 0 0 0 0 Thymus - enlarged or enlargement In Control 0 0 0 2 0 2 region which thymus usually occupies 25 ppm 0 0 0 0 0 0 G-05 75 ppm 0 0 0 0 0 0 Splenomegaly * tumor related G-07 Control 0 0 0 2 0 2 25 ppm 0 0 1 1 2 4 75 ppm 0 0 0 1 0 1 Tumor In area of pancreas and spleen Control 0 0 0 0 1 1 G-10 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 TUMORS Subcutaneous tumor - mammary and mid- Control 0 0 0 3 2 5 cervical region, number per rat - 1 25 ppm 0 1 2 3 1 7 B-02 (1) 75 ppm 1 0 2 5 1 9 Subcutaneous tumor - mammary and mid- Control 0 0 0 2 0 2 cervical region, number per rat - 2 25 ppm 0 0 0 0 0 0 B-02 (2) 75 ppm 0 0 0 0 0 0 Subcutaneous tumor - eye, ear, or head Control 0 0 1 2 0 3 region, number per rat 1 25 ppm 0 0 0 4 1 5 B-03 75 ppm 0 1 0 1 0 2 Subcutaneous tumor - body/limb, number Control 0 1 1 0 0 2 per rat - 1 25 ppm 0 0 0 0 1 1 B-04 (1) 75 ppm 0 0 0 2 0 2 Subcutaneous tumor - body/limb, number Control 0 0 0 0 0 0 per rat * 2 25 ppm 0 0 0 1 0 1 B-04 (2) 75 ppm 0 0 0 1 0 1 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082355 -66- table 17 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Male \ats Number of rats necropsied during che time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 36 LIVER Undifferentiated sarcoma with in- Control 0 0 0 1 0 1 vasion of lung and diaphragm 25 ppm 0 0 0 0 0 0 H-19 75 ppm 0 0 0 0 0 0 Metastatic adrenal cortical carcinoma Control 0 0 0 0 0 0 H-29 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 1 1 RESPIRATORY SYSTEM Lungs Metastatic adrenal cortical carcinoma Control 0 0 0 1 0 1 R-37 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 Well-differentiated bronchial and/or Control 0 0 0 0 1 1 alveolar carcinoma without 25 ppm 0 0 0 0 0 0 metastasis 75 ppm 0 0 0 0 0 0 R-39 Metastatic thyroid gland carcinoma Control 0 0 0 0 1 1 R-40 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Undifferentiated sarcoma with a pul- Control 0 0 0 0 0 0 monary metastasis 25 ppm 0 0 0 0 0 0 R-42 75 ppm 0 0 0 1 0 1 Metastatic mucinous cystadenocarcinoma Control 0 0 0 0 0 0 R-43 25 ppm 0 0 1 0 0 1 75 ppm 0 0 0 0 0 0 URINARY SYSTEM Nephroblastoma U-ll Control 0 1 0 0 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Transitional cell papilloma U-20 Control 0 0 0 0 1 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 GASTROINTESTINAL TRACT Stomach Metastatic adenocarcinoma of probable Control 0 0 0 0 0 0 intestinal origin 25 ppm 0 0 0 1 0 1 G-12 75 ppm 0 0 0 0 0 0 Small Intestine Mucinous cystadenocarcinoma without Control 0 0 0 0 1 1 metastasis 25 ppm 0 0 0 1 0 1 G-30 75 ppm 0 0 0 2 1 3 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. si* 0B2356 -67- table 17 (Continued) VINYLIDENE CHLORIDE; A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 GASTROINTESTINAL TRACT (cont'd) Small Intestine (cont'd) Undifferentiated sarcoma with osseous Control 0 0 0 1 0 1 metaplasia without metastasis 25 ppm 0 0 0 0 0 0 G-40 75 ppm 0 0 0 0 0 0 Mucinous cystadenocarcinoma with Control 0 0 0 0 0 0 metastasis to lung 25 ppm 0 0 1 0 0 1 G-41 75 ppm 0 0 0 0 0 0 Sclerosing adenocarcinoma of probable Control 0 0 0 0 0 0 intestinal origin with metastasis 25 ppm 0 0 0 1 0 1 to stomach 75 ppm 0 0 0 0 0 0 G-37 Salivarv Gland Carcinoma, most probably salivary Control 0 0 0 0 0 0 gland in origin without metastasis 25 ppm 0 0 0 0 0 0 G-70 75 ppm 0 1 0 0 0 1 Pleomorphic sarcoma of probable sail- Control 0 0 1 0 0 1 vary gland origin 25 ppm 0 0 0 0 0 0 G-72 75 ppm 0 0 0 0 0 0 PANCREAS Pancreatic acinar adenoma P-01 Control 0 0 3 13 8 24 25 ppm 0 0 2 3 1 ' 6 75 ppm 0 0 5 12 6 23 Pancreatic acinar adenocarcinoma with- Control 0 0 0 0 0 0 out metastasis 25 ppm 0 0 0 2 0 2 P-02 75 ppm 0 0 0 0 0 0 Mixed exocrine and endocrine adenoma Control 0 0 0 0 0 0 P-08 25 ppm 0 0 0 0 1 1 75 ppm 0 0 0 0 0 0 Pancreatic islet cell adenoma P-20 Control 0 0 1 3 8 12 25 ppm 0 0 0 1 2 3 75 ppm 0 0 1 3 1 5a REPRODUCTIVE SYSTEM Testis Interstitial cell adenoma of the testis Control 0 0 0 0 2 2 X-08 25 ppm 0 0 0 0 1 1 75 ppm 0 0 0 3 0 3 Mesothelioma of the tunica albuginea Control Q 0 0 0 0 0 X-09 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 2 3 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05 08^S1 -68- table 17 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 36 REPRODUCTIVE SYSTEM (cant'd) Testis (cont'd) Undifferentiated sarcoma without me- Control 0 0 0 0 0 0 tastasis, moat probable neurofibro- 25 ppm 0 0 0 1 0 1 sarcoma 75 ppm 0 0 0 0 0 0 X-ll nervous system Brain Astrocytoma N-03 Control 0 0 0 1 0 1 25 ppm 0 0 0 1 0 1 75 ppm 0 1 0 0 0 1 Intracranial pleomorphic sarcoma Control 0 0 0 0 0 0 without metastasis 25 ppm 0 1 0 0 0 1 N-12 75 ppm 0 0 0 0 0 0 Pituitary Pituitary adenoma N-44 Control 0 0 3 16 4 23 25 ppm 0 0 3 8 1 12a 75 ppm 0 1 3 8 2 14a Atypical adenoma N-54 Control 0 0 0 0 0 0 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 0 0 0 Pituitary adenocarcinoma without in- Control 0 0 0 1 0 1 vasicn of brain 25 ppm 0 0 0 0 0 0 N-48 75 ppm 0 0 0 0 0 0 Pituitary adenoma based on gross Control 0 0 0 0 0 0 examination but microscopic section 25 ppm 0 0 0 2 0 2 not available for evaluation 75 ppm 0 0 0 0 0 0 n-55 Total number of animals with a pituitary tumor Control 0 0 3 17 4 24 25 ppm 0 0 3 11 1 15a 75 ppm 0 1 3 8 2 14* Spinal Cord Neurofibrosarcoma vithln pelvic canal Control 0 0 1 1 0 2 or ventral thoracic region without 25 ppm 0 0 0 0 0 0 metastasis 75 ppm 0 0 0 0 0 0 Peripheral Nerve Schwannoma in abdominal region - origin Control 0 0 0 0 0 0 uncertain 25 ppm 0 0 0 0 0 0 N-40 75 ppm 0 0 0 1 0 1 ADRENAL GLAND Cortex Adenoma of adrenal cortex A-25 Control 0 0 0 3 0 3 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 Significantly different from control data when analyzed using Fisher's Exact probability Test, p<0.05. SL 082358 -69 TABLE 17 (Continued) VINYL1DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Male Rats Number of rats necropsied during the time period Indicated ControL 25 ppm 75 ppm ADRENAL GLAND (cont'd) Cortex (cont'd) Adrenal cortical carcinoma without metastasis A-34 Control 25 ppm 75 ppm Adrenal cortical carcinoma with metastasis to lung A-37 Control 25 ppm 75 ppm Adrenal cortical carcinoma with metastasis to liver A-38 Control 25 ppm 75 ppm Medulla Adrenal pheochromocytoma, unilateral A-47 Control 25 ppm 75 ppm Adrenal pheochromocytoma, bilateral A-48 Control 25 ppm 75 ppm Malignant pheochromocytoma with no apparent metastasis - unilateral A-50 Control 25 ppm 75 ppm Total number of animals with a pheochromocytoma Control 25 ppm 75 ppm THYROID Thyroid adenoma T-01 Control 25 ppm 75 ppm Thyroid adenocarcinoma without metaatasls T-02 Control 25 ppm 75 ppm Thyroid carcinoma with metastasis to cervical lymph node* and lung T-ll Control 25 ppm 75 ppm Total number of animals with a thyroid tumor Control 25 ppm 75 ppm SUBCUTANEOUS TISSUE Subcutaneous fibroma S-02 Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 000000 000 101 000 0 00 000 1 0 1 000 0 0 0 Q00 101 000 000 000 0 00 00 0 0 1 1 0 0 3 14 5 22 0 0 1 16 3 20 0 0 4 12 7 23 0 0 0 8 3 11 0 0 0 11 4 15 0007 i8 000 2 i 3 00010 1 000 2 0 2 0 0 3 24 9 36 0 0 1 28 7 36 0 0 4 21 9 34 0004 5 9 0 0 2 4 4 10 0015i7 0015 1 7 0 0 0 1 i 2. 0 0 0 0 i la 0000 i1 000 0 0 0 000000 0 0 1 9 7 17 0 0 2 5 5 12a 0 0 1 5 2 8a 0 0 0 6/4 1/1 7/5? 0 1/1 1/1 4/3 0 6/5b 1/1 0 0 5/4 0 6/5b Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. Number of tumors/number of animals with tumors. SL 082359 -70- table 17 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Male Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 83 8 86 SUBCUTANEOUS TISSUE (cont'd) Subcutaneous fibrosarcoma without Control 0 1/1 0 0 0 1/1" metastasis 25 ppm 0 0 0 0 0 0 b S-OS 75 ppm 0 0 0 1/1 0 1/1 Subcutaneous fibrosarcoma with metastasis to lung S-06 Control 25 ppm 75 ppm 0 0 0 000 00 0 0 1/1 0 00 0 0b 0 i/r Undifferentiated sarcoma with metas- Control 0 0 0 0 0 0 tasis to lung S-08 25 ppm 0 0 0 0 0 0 b 73 ppm 0 0 0 1/1 0 l/l6 Fibrolipoma S-09 Control 0 0 0 0 0 h 25 ppm 0 0 0 0 1/1 1/1 75 ppm 0 0 0 0 0 0 Neurofibrosarcoma S-10 Control 0 0 0 0 0 0 25 ppm 0 0 0 0 0 0 b 75 ppm 0 0 0 0 1/1 i/r MAMMARY GLAND Fibroadenoma/adenofibroma S-25 Fibroma S-26 Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 0 0b 0 1/1 0 0 1/17 0 1/1 1/1 0 2/r 0 0 0 1/1 l/lb 00000 00000 Total number of animals with a subcu- Control 0 1 0 4 2 7 taneous or mammary gland tumor 25 ppm 0 1 2 3 1 7 S-02, S-05, S-06, S-08, S-09, S-10, 75 ppm 1 0 2 7 1 11 S-25, S-26 INTEGUMENT Sebaceous squamous cell carcinoma of Control 0 0 1 1 0 2 the external auditory canal without 25 ppm 0 0 0 2 1 3 metastasis (Zymbal gland carcinoma) 75 ppm 0 0 0 1 0 1 S-51 Squamous cell carcinoma of the orbit Control 0 0 0 1 0 1 of the eye without metastasis 25 ppm 0 0 0 0 0 0 S-57 75 ppm 0 0 0 0 0 0 Undifferentiated sarcoma of probable Control 0 0 0 0 0 0 neural origin without metastasia 25 ppm 0 0 0 1 0 1 S-59 75 ppm 0 0 0 0 0 0 Unclassified malignant epithelial Control 0 0 0 0 0 0 neoplasm of the nose 25 ppm 0 0 0 1 0 1 S-60 75 ppm 0 0 0 0 0 0 Squamous papilloma with keratinization Control 0 0 0 0 0 0 S-62 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 0 0 0 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. Number of tumors/number of animals with tumors. SL 0B2360 - -71- table 17 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Male Rats Number of rats necropsied during the time period Indicated Control 25 ppm 75 ppm 0-6 Months 3 4 4 7-12 Months 5 3 4 13-18 Months 19 18 19 19-24 Months 46 47 51 Terminal Cumulative Kill Results 13 86 13 85 8 86 MUSCULOSKELETAL SYSTEM Osteogenic sarcoma of the rear limb Control 0 0 0 0 0 0 without metastasis 25 ppm 0 0 0 0 0 0 M-08 75 ppm 0 0 0 1 0 1 Hard palate - squamous cell carcinoma Control 0 0 0 0 0 0 M-09 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 LYMPHORETICULAK SYSTEM Lymphosarcomas and Leukemias Generalized leukemia with multiple Control 0 0 0 2 0 2 tissue metastasis 25 ppm 0 0 1 1 1 3 L-65 75 ppm 0 0 0 2 0 2 Lymphosarcoma of the small intestine Control 0 0 0 1 0 1 without metastasis 25 ppm 0 0 0 0 0 0 L-67 75 ppm 0 0 0 0 0 0 Lymphosarcoma of the large intestine Control 0 0 0 0 0 0 without metastasis 25 ppm 0 0 0 1 0 1 L-68 75 ppm 0 0 Q 0 0 0 Thymus Thymoma L-52 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Other Lymph Nodes Metastatic thyroid gland carcinoma Control 0 0 0 0 1 1 to cervical lymph nodes 25 ppm 0 0 0 0 0 0 L-37 75 ppm 0 0 0 0 0 0 Total number of primary tumors in the male rats as previously listed Control 25 ppm 75 ppm 0 0 1 2 14 86 43 145 2 12 66 21 101 3 16 71 24 115 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082361 -72- table 18 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Number of Male Rats for Which The Specified Tissue Was Examined Microscopically Number of rats necropsied during the time period indicated Liver Heart Kidney Lungs Pancreas Spleen Skeletal Muscle Mediastinal or Perirenal Fat Salivary Gland Aorta Esophagus Trachea Parathyroid Thyroid Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months 3 4 4 3 4 4 3 4 4 3 4 4 3 4 4 i 0 3 1 3 3 1 1 2 0 0 2 1 0 3 2 0 4 2 4 4 2 4 3 0 4 i 0 3 1 7-12 Months 5 3 4 5 3 4 5 3 4 S 3 4 5 3 4 5 1 4 5 3 4 3 2 4 4 0 3 4 0 3 4 0 3 3 2 3 5 3 4 0 2 i 3 3 2 13-18 Months 19 18 19 19 18 19 17 18 19 19 18 19 19 18 19 16 5 19 17 16 19 11 13 14 17 0 19 13 0 16 15 4 17 17 11 17 18 16 19 11 15 15 15 14 17 19-24 Months 46 47 31 Terminal Cumulative Kill Results 13 86 13 85 8 86 46 47 51 46 47 51 46 47 51 46 47 50 43 9 50 45 46 49 42 14 42 39 2 45 41 0 47 43 10 44 41 30 44 44* 46 47 41 38 40 13 13 8 13 13 8 13 13 8 13 13 8 13 8 8 13 13 8 13 9 8 13 5 7 10 5 8 13 5 6 12 6 5 12 13 7 11 13 6 86 85 86 84 85 86 86 85 86 86 85 85 78 23 84 81 81 83 70 39 70 73 7 76 69 5 77 77 19 74 75 53 73 81 82 80 63 72 63 44 13 75 ' 43 13 76 46 8 74 SL 082362 -73- TAELE IS (Continuec) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Number of Male Rats for Which The Specified Tissue Was Examined Microscopically Number of rats necropsied during the time period indicated Stomach Small Intestine Large Intestine Mesenteric Lymphoid Tissue Mesenteric Vessels Urinary Bladder Testes Epididymis Prostate Accessory Sex Gland Peripheral Nerve Spinal Cord Pituitary Adrenal Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 72 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months 3 4 A 1 2 3 1 0 3 1 0 2 0 0 2 0 0 2 1 0 3 1 0 3 1 0 3 1 0 1 1 0 3 1 0 0 1 0 2 0 3 1 1 2 2 7-12 Months 5 3 4 4 3 4 3 0 4 3 0 3 3 0 4 4 0 4 4 0 4 4 0 4 4 0 3 2 0 2 4 0 4 3 0 4 2 0 3 1 3 3 5 3 4 13-18 Months 19 18 19 15 16 17 11 2 15 8 0 14 9 4 15 10 3 16 18 0 19 18 1 17 18 0 18 12 0 6 17 0 19 9 0 8 11 0 13 8 13 16 17 18 18 19-24 Months 46 47 51 Terminal Cumulative Hill Results 13 86 13 85 8 86 46 12 78 46 13 80 48 8 80 36 13 64 3 7 12 51 8 81 32 13 57 246 40 8 67 39 13 64 6 7 17 40 7 68 39 13 66 8 6 17 39 7 68 42 13 78 4 7 11 48 8 82 43 13 79 269 51 8 83 41 12 76 26a 50 8 82 21 12 48 4 6 10 12 8 29 43 13 78 4 6 10 49 3 83 36 11 60 167 40 8 60 45 13 72 145 44 8 70 33 8 50 34 9 62 34 7 61 43 13 79 47 13 83 50 8 82 SL 082363 -74- table 18 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOCENICITY STUDY IN RATS Number of Male Rats for Which The Specified Tissue Was Examined Microscopically Number of rats necropsxed during the time period indicated Cerebellum Cerebral Cortex Eyes Skin Mediastinal Lymphoid Tissue Mediastinal Vessels Cervical Lymph Nodes Other Lymphoid Tissue Mesenteric Fat Preputial Gland Diaphragm Medulla Oblongata Pineal Gland Ear Canal Epididymal Fat Pad Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months 3 4 4 1 3 3 1 3 3 1 0 1 1 0 0 0 0 It 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 7-12 Months 5 3 4 5 3 3 5 3 4 2 0 2 0 0 0 5 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 13-18 Months 19 18 19 15 17 19 16 17 19 10 0 12 1 0 6 14 0 18 0 0 0 3 0 4 0 0 0 0 0 0 2 0 0 0 0 0 0 6 7 0 0 0 0 0 0 0 0 1 19-24 Months 46 47 51 40 46 48 46 47 50 31 1 41 8 3 9 40 3 43 1 0 0 5 0 6 1 1 0 1 0 1 0 1 0 1 0 0 2 6 2 1 1 3 0 2 0 0 C 1 Terminal Cumulative Rill Results 13 86 13 85 8 86 13 74 13 82 8 81 13 81 13 83 8 84 13 57 13 14 1 57 8 18 47 6 21 13 72 53 7 75 45 00 00 3 11 11 1 11 12 0i 00 12 00 01 02 01 00 01 00 00 02 0 13 0 10 01 23 03 00 13 00 00 00 02 SL 082364 -75- table 19 VINYLIDENE CHLORIDE; A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm LIVER Enlarged or congested with or without secondary darkening H-01 Atrophied (decrease in size) H-02 Small white foci (also pale) H-03 Red subcapsular foci H-04 Roughened due to chronic pulmonary congestion H-06 Dark and discolored H-07 Fluid-filled cysts H-08 Accentuation of lobular pattern H-ll Paleish discoloration H-12 Strangulation, folding or other distortion, of a lobe H-14 Mottled H-15 Diaphragmatic hernia H-17 RESPIRATORY SYSTEM Thoracic Cavity Pleural adhesions K-Ql Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 00 00 04 00 00 00 00 00 00 00 00 00 00 00 00 00 00 c0 00 00 00 00 00 00 00 00 02 00 00 00 10 00 00 00 00 00 00 00 00 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 1416 1203 1 6 1 12 04 26 0303 04 15 0 246 1 2 03 0617 1 3 11 15 2 6 2 10a 0 1 5 6a 0000 0000 0101 0101 0000 0000 0022 0202 0011 1 6 4 11 13 15 0415 3 8 2 13 2709 3409 0 101 0000 0000 0 1 24 0 10 1 0000 0101 00 00 0000 0000 0000 0101 aSignificantly different from control data when analyzed using Fisher' s Exact Probability Teat, p<0 .05. SL 082365 -76- table 19 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Noncumorous Gross Pathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm Thoracic Cavity (cont'd) Hvdrothorax K-04 Control 25 ppm 75 ppm Pleuritis K-17 Control 25 ppm 75 ppm Luna Atelectasis (edematous) K-05 Control 25 ppm 75 ppm Pneumonia K-09 Control 25 ppm 75 ppm Golden brown pigment K-10 Small red foci K-02 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Consolidation K-06 Control 25 ppm 75 ppm Bronchiectasis R-12 Control 25 ppm 75 ppm Diffuse K-14 'ned areas throughout lung Control 25 ppm 75 ppm Small pale subpleural foci K-15 Congestion with or without edema K-16 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Focal pulmonary fibrosis P-04 Control 25 ppm 75 ppm URINARY SYSTEM Urinary Bladder Distention with urethral obstruction 2E-19 Control 25 ppm 75 ppm 0-6 Months 1 1 1 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7-12 Months 1 5 4 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 13-18 Months 14 23 15 1 0 0 0 0 0 0 0 0 1 2 1 0 0 0 1 2 1 0 0 0 0 2 1 1 1 0 3 1 2 0 0 0 0 0 0 1 0 0 19-24 Months 49 46 48 Terminal Cumulative Rill Results 19 84 11 86 16 84 3 15 5 05 6 17 001 001 0 00 3 36 202 5 16 5 1 a 13 4 20 14 1 16 01i 101 112 124 305 304 10i 000 101 3 0A 7 1 10 11 0 12 012 102 303 9 6 18 8 11 10 7 20 101 000 202 000 000 101 102 0 00 000 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 08236-6 -77- table 19 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions in Female Rats Number of rats necropsied during the time period Indicated Control 25 ppm 75 ppm Urinary Bladder (cont'd) Thickened wall or changes suggestive <of Control cystitis 2E-24 & 2E-17 25 ppm 75 ppm Hematuria 2E-26 Control 25 ppm 75 ppm Kidney Chronic renal disease with or without cyst formation, minimal I-02-L Control 25 ppm 75 ppm Chronic renal disease with or vithout cyst formation, moderate I-02-M Control 25 ppm 75 ppm Chronic renal disease with or without cyst formation, severe I-02-S Control 25 ppm 75 ppm Enlarged and congested 1-03 Control 25 ppm 75 ppm Dilated renal pelvis 1-04 Control 25 ppm 75 ppm Mineralization or granular debris within renal pelvis 1-05 & 1-07 Control 25 ppm 75 ppm Hydronephrosis 1-06 Control 25 ppm 75 ppm Dark and discolored 1-09 Control 25 ppm 75 ppm Cysts not directly associated with chronic renal disease 1-12 Control 25 ppm 75 ppm Renal failure - probable causa of death or poor condition 1-13 Control 25 ppm 75 ppm White foci 1-14 Control 25 pptt 75 ppm 0-6 Months i i i 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 000000 000000 000 101 000 000 000000 000101 0 0 2 9 6 17 0 0 1 1 0 2* 0 0 0 6 4 10 0000 2 2 00001 1 000022 000 101 000000 000 112 000101 000000 000 202 000000 000 10 1 00001 1 000000 000000 000 101 00 0 000 000000 000 101 0 0 100 1 000 20 2 000 10 1 000 202 000 000 000 0 1 1 000112 000 000 000 0 1 1 000000 000 101 000000 *Significantly different from control data when analyzed using Fisher' s Exact Probability Test, p<0.05. SL 082367 -78- table 19 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions In Female Rats Number of rats necropsled during Che time period indicated Control 25 ppm 75 ppm Kidney (cont'd) Decrease in size 1-15 Pale (not directly associated with chronic renal disease) 1-17 Pyelonephritis - inf lamination of the kidney and renal pelvis 1-20 Kidney - infarct, focal P-11 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm CARDIOVASCULAR SYSTEM Heart Left atrial thrombosis L-02 Degeneration or dilated ventricles (including flaccid ventricles) L-03 S, L-04 Pericarditis L-05 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Aorta Vessels - dilated and inelastic L-06 Control 25 ppm 75 ppm Vessels Periarteritis (vasculitis), sclerosis, and other related changes Including thrombosis of a vessel L-08 Control 25 ppm 75 ppm Nodular areas in mesenteric vessels or mesentery - vascular in nature P-05 Control 25 ppm 75 ppm ABDOMINAL cavity Intraabdominal fluid or blood F-13 Control 25 ppm 75 ppm Fibrinous peritonitis F-14 Control 25 ppm 75 ppm 0-6 Months i i i 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 36 16 84 0003 14 000000 0 00 2 02 0 00 0 00 000 000 001 102 0000 00 000 0 00 000 1 01 000000 000 10 1 000000 000 101 00 010 1 000112 000404 0005 05 000202 1 0 00 0 1 000000 000000 000 10 1 0002 02 000303 000303 00 00 00 000112 000000 0000 00 0000 1 1 001203 000101 000000 001001 00 0000 0 00000 Not significantly different from control data when analyzed using Fisher's Exact Probability Test* p(0.05. SL 0823 68-,, -79- table 19 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions In Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm ADIPOSE TISSUE Depleted or any decrease In quantity D-01 Control 25 ppm 75 ppm Obese or excessive quantity including "fat rat syndrome" D-02 Control 25 ppm 75 ppm Strangulation of a portion of abdominal Control fat 25 ppm D-03 75 ppm GASTROINTESTINAL TRACT AND INTRAABDOMINAL CAVITY Salivary Gland Salivary gland inflammation F-24 Control 25 ppm 75 ppm Stomach Gastric ulcers or erosions or focal hemorrhage F-05 & F-02 Control 25 ppm 75 ppm Gastric distention with air F-04 Control 25 ppm 75 ppm Thickened gastric mucosa (hyperkeratosis) F-26 Control 25 ppm 75 ppm Roughening of mucosal surface F-36 Control 25 ppm 75 ppm Gastric edema F-37 Control 25 ppm 75 ppm Intestinal Tract Decreased amount of ingtsta or feces in the gastrointestinal tract F-07 Control 25 ppm 75 ppm Bloody fluid material or darkening of Control ingesta in gastrointestinal tract - 25 ppm associated with chronic renal disease 75 ppm F-29 Bloody fluid material or darkening of ingesta in gastrointestinal tract associated with malocclusion F-30 Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 00 01 00 00 00 00 Q0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 01 00 00 00 00 00 00 00 13-18 Months 14 23 15 0 3 0 0 4 3 0 0 1 0 0 0 1 2 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 18 2. 20 18 1 23 18 2 20 213 0 04 003 011 202 001 033 000 011 405 s 1 11 11 0 11 000 202 101 203 000 101 202 000 0 00 000 101 000 7 18 5 17 8 08 000 000 101 101 000 000 Not significantly different from control data when analyzed usxng Fisher's Exact Probability Test, p<0.05. SL 082369 -80- table 19 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm Intestinal Tract (cont'd) Bloody fluid material or darkening of lngesta in gastrointestinal tract associated with cannibalism F-31 Control 25 ppm 75 ppm Bloody fluid material or darkening of lngesta In gaatrointestinal tract associated with other causes F-32 Control 25 ppm 75 ppm Bloody fluid material or darkening of Control ingesta in gastrointestinal tract - 25 ppm associated with an undetermined cause 75 ppm F-33 Large Intestine Parasites (pinworma) F-ll Control 25 ppm 75 ppm Cecum Hemorrhagic or edematous, thickened, whltelsh discoloration, gelatinous material or inflammation indicative of uremic typhlitis F-1S 6 F-25 Control 25 ppm 75 ppm REPRODUCTIVE SYSTEM Ovary Cyst 2E-02 Control 25 ppm 75 ppm Inflammation or abscess 2E-03 Control 25 ppm 75 ppm Uterus Atrophy 2E-04 Control 25 ppm 75 ppm Malformation 2E-06 Control 25 ppm 75 ppm Inflammation 2E-08 Control 25 ppm 75 ppm 0-6 Months i i 1 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 0 00000 0 00 1 0 1 000 202 0 00 2 02 000202 0001 01 000 0 11 000 101 0 0000 0 000303 000101 00 10 0 1 000101 000101 000000 0 005 1 6 0114 28 0 1 0 6 7 14a 0 0 0 10 1 0 00 101 000 11 2 0001 0 1 000000 000 3 14 000000 0 0 00 00 000 101 00 0 10 1 000000 000 101 Significantly different from control data when analyzed using Fisher's Exact Probability Test* p<G*Q5. SL 082370 -81- TABLE 19 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions in Female Rats Number of rata necropsied during the time period indicated Control 25 ppm 75 ppm Uterus ^cont'd^ Hemorrhage or fluid accumulation 2E-09 Control 25 ppm 75 ppm Hyperplasia with or without cysts 2E-14 Control 25 ppm 75 ppm Dilated uterine horn with fluid 2E-21 Control 25 ppm 75 ppm Clitoral Gland Clitoral gland abscess 2E-13 NERVOUS SYSTEM Pituitary Hemorrhagic foci N-06 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Red foci with focal enlargement N-09 Control 25 ppm 75 ppm Brain Focal compression of the base of the brain as a result of an enlarged pituitary N-ll Control 25 ppm 75 ppm ENDOCRINE SYSTEM Parathyroid hyperplasia 0-02 Control 25 ppm 75 ppm ADRENAL GLAND Hemorrhagic appearance on cross section Control J-04 25 ppm 75 ppm Mottled appearance J-05 Control 25 ppm 75 ppm Decrease in size J-06 4 J-07 Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 00 1 00 1 0010Q 1 00 0 101 0 0 0 8 12 20 0 0 3 5 6 14 0 1 5 5 12 23 0000 11 0000 00 00 0000 000l12 000101 00 0 0 00 00 0 4 26 00 13 15 00 1 3 04 00 1012 00002 2 00 102 3 000101 00 00 0 0 00010 1 00 0 10 1 00 0000 000101 000 101 0 0 0 0 o. 0 000101 0 0 0 12 12 24 0 0 2 11 5 18 0 0 1 12 9 22 000000 000022 000011 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082371 82- table 19 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm INTEGUMENTARY SYSTEM Mammary gland hyperplasia B-05 Control 25 ppm 75 ppm Galactocele formation - or secretory material in mammary tissue B-07 Control 25 ppm 75 ppm Subcutaneous edema B-ll Control 25 ppm 75 ppm LYMPHORETICULAR SYSTEM Lymph node(s) - swollen and/or congested, edematous, local, containing hematogenous pigment or cystic G-01 Control 25 ppm 75 ppm Lymph node(s) - swollen and congested. edematous, general, containing hematogenous pigment or cystic G-02 Control 25 ppm 75 ppm Splenomegaly - extramedullary hematopolesis (no indication of tumorous process) G-06 Control 25 ppm 75 ppm EYE Hemorrhage and ulceration C-02 Control 25 ppm 75 ppm Corneal opacity, unilateral C-04-u Control 25 ppm 75 ppm Corneal opacity, bilateral C-04-bi Control 25 ppm 75 ppm Cataracts, bilateral C-05-bi Control 25 ppm 75 ppm Hyperemia C-09 Control 25 ppm 75 ppm GENERAL Postmortem change, minimal A-02-L Control 25 ppm 75 ppm 0-6 Months i 1 i 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 ,0 0 2 6 10 13 0 0 0 0 1 1 4 2 3 6 1393 001 3 37 000 213 000 202 000000 000000 000101 000369 001 315 010012 001 102 000 101 000 00 0 0 0 7 9 2 18 0 0 3 14 0 17 1 0 4 7 0 12 000000 001r 01 000 00 00 i2 14 000000 00 0 4 04 0000 2 2 00 00 0 0 00 000 0 00 0000 00 00 00 00 0 10 1 00 0000 00 0000 00 0 10 1 10 1204 00 1102 000000 aSignificantly different from control data when analyzed using Fisher's Exact Probaoility Test, p<0.05. SL 082372-, 83- TABLE 19 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Gross Pathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm GENERAL Rout'd) Postmortem change, moderate A-02-M Control 25 ppm 75 ppm Postmortem change, severe A-02-S Control 25 ppm 75 ppm Cannibalism A-03 Control 25 ppm 75 ppm Emaciation - decrease in body condition Control A-04 25 ppm 75 ppm Jaundice A-05 Control 25 ppm 75 ppm Anemia A-06 Control 25 ppm 75 ppm Nasal or ocular exudate A-07 Control 25 ppm 75 ppm Malocclusion A-09 Control 25 ppm 75 ppm Ulceration of hard palate, tongue, or opposaing gingival surface with or without inflammation A-10 Control 25 ppm 75 ppm Perineal fecal material secondary to chronic renal diseaae, malocclusion. and other cause A-14 Control 25 ppm 75 ppm Brown pigmented (porphyrin) material in facial area and/or forellmbs A-17 Edema of all or some of the tissues of the body A-18 Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 terminal Cumulative Kill Results 19 84 11 86 16 84 0006 06 1 i 0 8 0 10 001506 001 203 010 102 000 202 0110 13 10 100 2 00 210 3 0 0 0 9 1 10 01 0 3 04 00 0 40 4 00 0000 00 0 000 000 101 0 0 4 6 0 10 0 1 5 4 0 10 101507 000202 001304 00 1102 00 01 01 00 3205 00 001 1 000 101 00 1102 00 0 000 00000 0 000 10 1 000101 000000 000 10 1 000 10 1 00 0 10 1 0 0 0 000 000000 Not significantly different from control. data when analyzed using Fisher 's Exact Probability Tesc, p<0.05. SL 082373 -84- table 20 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during Che date period indicated Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 liver Foci of eosinophilic ground-glass Control 0 0 0 15 10 25 appearing cells 25 ppm 0 0 1 11 3 15* tt-01 75 pp* 0 0 2 4 10 16 Area of eosinophilic ground-glass Control 0 0 2 2 3 7 appearing cells 25 ppm 0 0 0 4 1 5 H-02 75 ppm 0 0 1 i 0 2 Foci of clear cell hepatocytes H-03 Control 0 0 0 0 2 2 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 0 0 0 Foci of basophilic hepatocytes H-05 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Foci of mononuclear cells within the Control 0 0 6 14 7 27 portal area or lobule 25 ppm 0 1 9 6 3 19a H-10 75 ppm 1 0 4 4 4 13 Centrllobular degeneration H-ll Control 1 0 i 10 0 12 25 ppm 0 1 3 10 1 15 75 ppm 0 0 3 13 0 16 Atrophy without fatty change H-12 Control 0 0 1 22 2 25 25 ppm 1 1 5 14 5 26 75 ppm 0 0 1 19 8 28 Focal necrosis H-14 Control 0 0 1 5 1 7 25 ppm 0 1 2 3 0 6 75 ppm 0 0 i 3 1 5 Focal vascular dilatation with hepato- Control 0 0 0 0 1 1 cellular alteration 25 ppm 0 0 0 0 0 0 a-is 75 ppm 0 0 0 0 0 0 Multlloculated biliary cyst H-17 Control 0 0 0 1 1 2 25 ppm 0 0 0 3 2 5 75 ppm 0 0 1 0 2 3 Fatty change - portal to midzonal Control 1 0 0 1 0 2 regions most predominant 25 ppm 0 0 0 0 0 0 H-19 75 ppm 0 0 0 0 0 0 Fatty change - occasional individual Control 0 0 1 2 2 5 hepatocytes 25 ppm 0 0 0 0 2 2 H-20 75 ppm 0 1 1 0 0 2 Fatty change - moderate to severe, Control 0 0 0 1 0 i involves several lobes to varying 25 ppm 0 0 0 0 0 0 degrees 75 ppm 0 0 1 0 0 i H-21 Fatty change * some within hepatocytes Control 0 0 0 0 2 2 of lobule - minimal 25 ppm 0 0 2 1 0 3 H-22 75 ppm 0 0 1 0 1 2 Significantly different from control data when analysed using Fisher's Exact Probability Test, p<0,05. SL 082374 -85 TABLE 20 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsled during the time period indicated Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months i 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 LIVER (cont'dj Fatty change - focal area(s) or foci Control 0 0 0 1 2 3 H-23 25 ppm 0 0 1 0 1 2 75 ppm 0 0 1 2 0 3 Fatty change - diffuse multifocal areas Control 0 0 0 1 0 1 H-24 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Fatty change - midronal in location Control 0 0 0 0 1 1 H-25 25 ppm 0 0 6 0 0 75 ppm 0 2 5 1 0 8* Total number of animals with fatty Control 1 0 1 6 7 15 change 25 ppm 0 0 9 1 3 13 H-19, H-20, H-21, H-22, H-23, H-24, 75 ppm 0 3 9 3 1 16 6 H-25 Focal biliary hyperplasia H-30 Extramedullary hematopoiesis H-31 Control 0 0 1 0 1 2 25 ppm 0 0 2 1 0 3 75 ppm 0 0 1 1 0 2 Conti 0 0 6 10 9 25 25 ppm 0 2 4 14 2 22 75 ppm 1 2 4 17 4 28 Periportal hypertrophy H-32 Control 0 0 6 15 7 28 25 ppm 0 2 8 3 2 20 75 ppm 0 2 6 9 1 18 Periportal fibrosis (biliary) and/or Control 0 0 0 1 0 1 sclerosis 25 ppm 0 0 0 0 0 0 H-33 75 ppm 0 0 0 1 0 1 Biliary hyperplasia with or without Control 0 0 0 4 2 6 fibrosis 25 ppm 0 0 0 3 0 3 H-34 75 ppm 0 0 0 1 0 1 Sinusoidal vascular dilatation H-35 Control 0 0 0 6 5 11. 25 ppm 0 Q 0 3 0 3 75 ppm 0 0 1 2 5 8 Capsular sclerosis secondary to die- Control 0 0 0 1 0 1 phragmatic hernia 25 ppm 0 0 0 0 0 0 H-36 75 ppm 0 0 0 0 0 0 Hematocyst formation beneath the capsule H-37 Centrilobular atrophy H-40 Centrilobular necrosis H-41 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0 0 0 1 0 0 0 0 0 0 00 00 000 00 00 1 01 0 10 16 13 90 1 3 13 2 19 0 8 12 4 24a 01809 0 3 9 1 13 0 0 10 0 10 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 08237 -86 TABLE 20 (Continued) VINYLIDENE CHLORIDE; A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months i i i 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 LIVER (coni'd) Aggregates of hematogenous pigment containing material in cells H-45 Control 25 ppm 75 ppm Portal area cells with more eoslnophilic staining affinity with or without swelling H-46 Control 25 ppm 75 ppm RESPIRATORY SYSTEM Trachea Focal subepithellal lymphoid Infiltrate Control R-01 25 ppm 75 ppm Chronic or acute tracheitia R-03 Control 25 ppm 75 ppm Exudative material in lumen R-04 Control 25 ppm 75 ppm Lungs Focal chronic interstitial pneumonitis R-21 & R-20 Control 25 ppm 75 ppm Focal peribronchiolar mononuclear cell infiltrate R-22 Control 25 ppm 75 ppm Focal areaa of alveolar histiocytosis with or without exudation of elveolar macrophages R-23 & R-29 Control 25 ppm 75 ppm Acute suppurative pneumonia R-26 Control 25 ppm 75 ppm Alveolar mineralisation R-27 Control 25 ppm 75 ppm Focal granulomatous inflammatory reaction in lung R-28 Control 25 ppm 75 ppm Cholesterol cleft formation in lung R-30 Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 000 1 1 00000 00000 00 0 0 0 2 1 104 40004 04 2 0 6 00 10 1 1 100 2 0 0 8 3 Ua 0 2 15 4 21 0 1 22 3 26* 00001 10001 00000 0 1 304 00000 00 303 0 11 42 15 68 4 20 28 7 60 4 14 29 12 60 K0 9 30 15 54a 0 13 21 5 1 6 21 9 37 00001 1000 1 00000 00000 00101 000 0 0 00000 01001 00000 0 1 001 00000 00000 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082376 -87- table 20 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months i i 1 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 Lungs (eont'd) Pulmonary changes consistent with cardiac or renal failure; edema, interstitial thickening and fibrosis, in flammatory cell infiltrate and exu dation of cells into alveoli, with or vithout atelectasis R-31 Control 25 ppm 75 ppm Focal areas of pleuritis R-32 Control 25 ppm 75 ppm Chronic murine pneumonia R-34 Control 25 ppm 75 ppm Interstitial fibrosis R-35 Control 25 ppm 75 ppm Macrophages in lumen of alveoli containlng hematogenous pigment R-36 Control 25 ppm 75 ppm Acute bronchitis R-37 Control 25 ppm 75 ppm URINARY SYSTEM Kidney Minimal degree of chronic nephropathy U-01 Control 25 ppm 75 ppm Moderate degree of chronic nephropathy U-02 Control 25 ppm 75 ppm Severe degree of chronic nephropathy U-03 Control 25 ppm 75 ppm End stage kidney U-04 Control 25 ppm 75 ppm Focal mononuclear cell infiltrate U-05 Control 25 ppm 75 ppm Multifocal mononuclear cell Infiltrate U-06 Control 22 ppm 75 ppm 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 005 00 3 00 3 000 010 000 016 0 1 16 0 1 19 000 000 001 000 011 004 000 010 000 0 9 36 3 15 33 4 8 32 04 7 029 0 4 14 003 001 001 000 010 001 042 000 220 0 10 000 000 27 03 25 01 01 00 2 4 Zl* 2 22 11 00 01 11 02 26 00 01 00 8 54 7 58 5 50 7 18 2 13 7 25 47 23 45 00 01 01 06 00 04 0i 00 00 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082377 -88- table 20 (Continued) VINYLIDENE CHLORIDE; A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during the Lime period indicated Control 25 ppm 75 ppm 0-6 Months i i i 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 ii 86 16 84 Kidney (cont'd) Mineralized deposits within kidney tubules, focal U-08 Control 25 ppm 75 ppm Cortical cyst U-09 Control 25 ppm 75 ppm Renal tubular epithelial hyperplasia U-10 Control 25 ppm 75 ppm Acute nephritis U-ll Control 25 ppm 73 ppm Acquired hydronephrosis U-12 Control 25 ppm 75 ppm Chronic pyelitis U-20 Control 25 ppm 75 ppm Ischemic necrosis U-21 Control 25 ppm 75 ppm Urogenital Tract Chronic urocystitis U-40 Control 25 ppm 75 ppm Focal hyperplasia of urinary bladder mucosa U-42 Control 25 ppm 75 ppm GASTROINTESTINAL SYSTEM Stomach Focal gastric ulceration and/or hemor rhage G-01 Control 25 ppm 75 ppm Mineralization of gastric mucosa G-02 4, G-04 Control 25 ppm 75 ppm Focal erosion of gastric mucosa G-05 Control 25 ppm 75 ppm 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7 23 4 12 19 0 5 17 001 000 000 000 000 000 000 000 00 1 000 000 001 000 0 10 000 000 001 000 00l 000 013 000 000 00 1 6 36 2 38 6 28 01 00 00 11 00 00 00 00 01 00 00 01 00 01 00 00 01 00 01 00 15 00 0c 01 Gastric edema of nonglandular portion G-06 Control 25 ppm 75 ppm Noc significantly different from control data vhen analyzed using Fisher's Exact Probability Test, p<0.05. SL 08237a -89- table 20 (Continued) VINYLIDENE CHLORIDE; A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 73 ppm 0-6 Months i i i 7-12 Months i 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 ii 86 16 84 Stomach (cont'd) Hyperkeratosis of nonglandular epl- Control 0 0 0 0 0 0 thelium in association with an 25 ppm 0 0 0 1 0 1 ulceration 75 ppm 0 0 0 0 0 0 G-07 Small Intestine Focal areas of chronic inflammation Control 0 0 0 1 0 1 and ulceration 25 ppm 0 0 0 0 0 0 G-35 75 ppm 0 0 0 0 0 0 Large Intestine Intestinal nematodiasis G--50 Control 0 0 0 6 4 10 25 ppm 0 0 0 0 0 0 75 ppm 0 0 3 6 2 11 Focal areas of chronic inflammation Control 0 0 0 1 0 1 and ulceration with or without 25 ppm 0 0 0 0 0 0 necrosis 75 ppm 0 0 0 0 0 0 G-53 Diverticulum G-54 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Cecum Edema of submucosa of cecum G-60 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Pancreas Focal atrophy of pancreatic acinar Control 0 0 2 10 10 22 tissue 25 ppm 0 0 0 0 1 1 P-03 75 ppm 0 0 1 10 2 13 Focal Interstitial pancreatitis Control 0 0 3 6 10 19 P-05 25 ppm 0 0 0 0 1 1 75 ppm 0 0 1 10 2 13 Focus of hyperplasia of the acinar Control 0 0 c 1 0 1 tissue 25 ppm 0 0 0 0 0 0 P-06 75 ppm 0 0 0 0 0 0 Necrosis of pancreatic tissue secondary Control 0 0 1 0 0 1 to a tumorous process 25 ppm 0 0 0 0 0 0 P-25 75 ppm 0 0 0 0 0 0 CARDIOVASCULAR SYSTEM Heart Minimal degree of focal myocardial Control 0 0 2 15 5 degeneration and fibrosis 25 ppm 1 0 1 7 1 "a C-01 75 ppm 0 0 1 8 2 n ^Significantly different from control data when analyzed using Fisher1 s Exact Probability Test, p<0 .05. SL 082379 -90- table 20 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats 06 Months 7-12 Months 13-18 Months Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 1 1 1 1 14 5 23 4 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 Heart (cont'dJ_ Moderate degree of focal myocardial Control 0 0 0 2 0 2 degeneration and fibrosis 25 ppm 0 0 0 1 0 i C-02 75 ppm 0 0 0 1 0 i Atrial thrombosis C-05 Control 0 0 0 1 2 3 25 ppm 0 0 0 i 0 1 75 ppm 0 0 a i 1 2 Endocardial fibrosis C-06 Control 0 0 0 0 0 0 25 ppm 0 0 0 2 0 2 75 ppm 0 0 0 1 0 1 Mononuclear cell infiltrate within Control 0 0 2 1 0 3 myocardium (myocarditis) 25 ppm 0 0 0 0 G 0 C-08 75 ppm 0 0 0 0 0 0 Endocardial fibrosis and sclerosis Control 0 0 0 1 0 1 secondary to a mediastinal tumor 25 ppm 0 0 0 0 0 0 C-09 75 ppm 0 0 0 0 0 0 Aorta Aortic mineralization C-25 Control 0 0 1 0 0 1 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 2 0 2 Blood Vessels Periarteritis and/or sclerosis of Control 0 0 0 2 3 5 mesenteric blood vessels and/or 25 ppm 0 0 0 0 1 1 other selected blood vessels 75 pps 0 0 0 1 1 2 C-41 Hyalinlzation, slcerosis and/or fib- Control 0 0 0 3 0 3 rinoid degeneration of mesenteric 25 ppm 0 0 1 0 0 1 and other blood vessels consistent 75 ppm 0 0 0 1 2 3 with varying degrees of mesenteric periarteritis 043 Thrombi in peripheral blood vessel Control 0 0 0 1 0 i C-47 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 REPRODUCTIVE SYSTEM Ovary Ovarian cyst X-60 Control 0 0 0 8 1 9 25 ppm 0 1 1 4 3 9 75 ppm 0 1 0 12 5 18 Atrophy of ovary or static appearance Control 0 0 0 3 7 10 X-6I & X-64 25 ppm 0 0 0 0 0 0 75 ppm 0 0 1 1 4 6 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082380 -91- TABLE 20 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 1 i 1 Ovary (cont'd) Inflammation of the ovary(ies) or oviduct(s) X-63 6 X-65 Control 25 ppm 75 ppm Uterus Multiple areas of cystic endometrial hyperplasia X-93 4 X-75 Control 25 ppm 75 ppm Squamous metaplasia with or vlchout keratinlzation or inflammation X-79 Control 25 ppm 75 ppm Endometritis (inflammation) X-90 Control 25 ppm 75 ppm Focal necrosis, ulceration and/or Inflammatlon of vaginal epithelium X-91 Control 25 ppm 75 ppm Hyalinization and sclerosis of tunica muscularis X-94 Control 25 ppm 75 ppm Clitoral Gland Absceaa of clitoral gland X-95 Control 25 ppm 75 ppm NERVOUS SYSTEM Brain Focal malacia of brain N-01 Control 25 ppm 75 ppm Foci of abscess formation or inflansaa- Control tion 25 ppm N-06 75 ppm Pressure necrosis with or without hemorrhage N-OS Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7-12 Months 1 5 4 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 13-18 Months 14 23 15 0 0 0 1 0 5 2 0 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 3 14 1 12 4 37 8 7 16 145 7 ii 24 0 24 112 3 28 2 14 022 303 202 000 000 101 0 00 000 101 000 101 101 000 001 202 000 000 000 000 101 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082381 -92- TAEuL ** VINYLIDENE CHLORIDE: A CHRONIC INHAL^ION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm NERVOUS SYSTEM (cont'd) Spinal Cord Vacuolization of spinal cord N-18 Control 25 ppm 75 ppm Peripheral Nerves Vacuolization of myelin within peripheral nerves N-32 Control 25 ppm 75 ppm Pituitary Sinusoidal dilatation within pituitary N-45 Control 25 ppm 75 ppm Hyperplasia N-5G Control 25 ppm 75 ppm Hematogenous pigment N-51 Control 25 ppm 75 ppm Microcyst N-52 Control 25 ppm 75 ppm Infarct with hemorrhage N-53 Control 25 ppm 75 ppm ADRENAL GLAND General Focal areas of extramedullary hemato- polesis A-01 Hematocyst formation within adrenala A-02 Vascular dilatation A-03 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Cortex Hvperplastic focus A-24 Atrophy A-26 Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0--6 Months i i i 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 7-12 Months 1 5 4 13-18 Montns 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 34 11 86 16 84 0 1 5 16 22 0 00 5 5 0 I 2 ii 14 0 0 3 14 17 00033 0 1 0 9 10 03249 13509 1 1 7 1 10 0200 2 0 1 20 3 00 i1 2 02002 0 1001 01001 0010 1 0100 1 0100 1 00000 00000 0 0 10 1 00213 1 2 5 0s 0 140 6 0 4 20 9 33 0 7 22 6 35 1 4 26 7 38 0 0' 0 0 0 0010 1 0 0 000 0 4 17 3 24 0 i 10 2 13. 0 2 204 0 0 000 000 11 0 0 000 ^Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<Q.05. SL 0823-J2 -93- TABLE 20 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during the time period Indicated Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 Cortex (cont'd) Focus of lipomatosis A-Z7 Control 25 ppm 75 ppm Necrosis secondary to tumor metastasis A-28 Control 25 ppm 75 ppm Medulla Hyperplastic focus A-46 Control 25 ppm 75 ppm THYROID AND PARATHYROID Thyroid Hyperplastic focus T-OS Control 25 ppm 75 ppm Parathyroid Hyperplasia T-20 Control 25 ppm 75 ppm SUBCUTANEOUS TISSUE, MAMMARY GLAND AND INTEGUMENT Subcutaneous Tissue Subcutaneous abscess S-01 Control 25 ppm 75 ppm Mammary Gland Hyperplasia S-30 Control 25 ppm 75 ppm Galactocele formation S-31 Control 25 ppm 75 ppm Chronic suppurative inflannnation S-42 Control 25 ppm 75 ppm MUSCULO-SKELETAL SYSTEM Atrophy of skeletal muscle M-01 Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 3 10 34 05 00 10 00 05 06 03 7 20 1 8a 2 7a 00 01 00 5 10 06 58 11 24 3115 0101 1001 0202 0101 00 00 10 01 01 01 11 01 00 01 00 00 0 10 00 03 11 00 12 34 23 56 13 12 00 01 00 00 0 10 11 36 aSigniicantly different from control data when analyzed using Fisher1 s Exact Probability Test, p<0.05. SL 082383 -94- VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY A+*D ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm EYE Chronic focal keratitis of eye E-01 Vacuolization (degeneration) of the lens proper -03 4 E-04 Chronic sclerosis of corneal area E-05 4 E-02 Focal corneal ulcer E-07 ADIPOSE TISSUE Mediastinal or perirenal fat atrophy B-01 LYMPHORETICULAR TISSUE Mediastinal Lymphoid Tissue Lymphoid hyperplasia L-04 Lymphadenitis L-06 Mesenteric Lymph Nodee Congestion and/or sinusoidal dila- tation L-26 Lymphoid hyperplasia L-27 Hematogenous pigment L-29 Lymphangiectasia L-30 Other Lymphoid Tissue Lymphoid hyperplasia L-35 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months i i 1 7-12 Months i 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 00 0 1 01 000000 0 0 0 1 01 00 2 204 000000 00 1 4 05 001i02 000000 0 00 0 00 0001 01 0000 00 00 0000 0 0 3 15 1 19 000000 0 0 1 16 5 22 0016 18 0 0 0 1 0 1. 0 0 1 18 3 22* 100001 0 000 00 000000 0 0 0 1 01 000 000 000 000 0002 1 3 000000 0 0 00 1 1 00 10 01 000000 000000 0002 13 000000 000 0 00 000011 000 3 14 000000 3Significantly different from control data when analyzed using Fisher' s Exact Probability Test, p<0,05. SL 082384 -95- table 20 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Nontumorous Histopathologic Lesions in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm LYMPHORETICULAR SYSTEM (eont'd) Spleen Atrophy with or without hemosiderin pigment L-38 Control 25 ppm 75 ppm Increased hemosiderin pigment L-39 Control 25 ppm 75 ppm Increased extramedullary hematopoiesis L-40 Control 25 ppm 75 ppm 0-6 Months i i i 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 i006 07 i22207 001102 000 2 0 2 0010 01 0000 00 0 0 11 28 7 46 0 1 15 26 1 43 1 4 11 21 5 42 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. Si 82385 96- VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Tumor or Tumor-like Lesions Grossly Recognized in Female Rais Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 43 Terminal Cumulative Kill Results 19 64 11 86 16 84 LIVER Nodule H-05 Control 0 0 0 0 3 3 25 ppm 0 0 0 0 2 2 75 ppm 0 0 1 0 0 1 Tumor - infiltrate and enlarged secon Control 0 0 0 0 0 0 dary to generalised lymphoprolifer- 25 ppm 0 0 1 1 0 2 ative process 75 ppm 0 0 0 0 0 0 H-10 RESPIRATORY SYSTEM Lung Focal nodule(s) K-08 Focal nodule(s) - metastatic K-08m Control 0 0 0 1 1 2 25 ppm 0 0 0 1 1 2 75 ppm 0 0 0 0 0 0 Control 0 0 0 1 0 1 25 ppm 0 0 0 1 0 1 7 5 ppm 0 0 0 0 1 1 KIDNEY Tumor - primary 1-10 Control 0 0 0 0 0 0 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 1 0 1 CARDIOVASCULAR SYSTEM Tumor of heart L-13 Control 0 0 0 0 0 0 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 0 0 0 Salivarv_Gland Salivary gland enlarged F-01 Control 0 0 0 0 1 25 ppm 0 0 0 0 0 75 ppm 0 0 0 0 0 Stomach Gastric tumor F-06 Control 0 0 0 0 0 25 ppm 0 0 0 1 0 75 ppm 0 0 0 0 0 Small Intestine Tumor or diverticulum F-08 Control 0 0 0 1 0 25 ppm 0 0 0 0 0 75 ppm 0 0 0 0 0 Large Intestine Tumor Control 0 0 0 1 0 25 ppm 0 0 0 0 0 75 ppm 0 0 0 0 0 Intra-abdominal Cavity Intra-abdominal tumor - origin uncer Control 0 0 0 1 0 tain F-16 25 ppm 0 0 0 0 0 7 5 ppm 0 0 0 2 0 Not significantly different from control data when lyzed using Fisher's Exact Probability Tes* 1 0 0 0 1 0 1 0 0 0 0 X. 0 2 SL 082386 -97- table 21 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Tumor or Tumor-like Lesions Grossly Recognized in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 7 5 ppm 0-6 Months 1 1 1 7-12 Months i 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 GASTROINTESTINAL SYSTEM (cont'd) Pancreas Noduie(s) within F-19 Control 0 0 0 3 3 6 25 ppm 0 0 0 0 2 2 75 ppm 0 0 0 1 0 1 Tumor involving pancreas and other Control 0 0 0 1 0 1 abdominal viscera 25 ppm 0 0 0 1 0 1 F-20 75 ppm 0 0 0 0 0 0 REPRODUCTIVE SYSTEM Ovary - tumor 2E-01 Control 0 0 0 4 1 5 25 ppm 0 0 0 0 0 O1 75 ppm 0 0 0 1 0 1 Uterus - endometrial polyp(s) 2E-05 Control 0 0 1 9 4 14 25 ppm 0 1 2 3 5 11 75 ppm 0 0 1 3 5 9 Uterus - tumor 2E-07 Control 0 0 1 1 2 4 25 ppm 0 0 0 0 2 2 75 ppm 0 0 0 1 1 2 Utero-cervix tumor 2E-10 Control 0 1 3 0 0 4 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 0 1 i Uterine tumor with metastasis to other Control 0 0 0 0 0 0 abdominal organs 25 ppm 0 0 0 1 0 1 2E-22 75 ppm 0 0 0 0 0 0 Vaginal tumor 2E-11 Control 0 0 0 1 0 i 25 ppm 0 0 0 0 1 i 75 ppm 0 0 0 0 0 0 NERVOUS SYSTEM Pituitary gland - increased in size or Control 0 0 4 18 14 36. irregular in shape with or without 25 ppm 0 0 4 11 7 n` associated generalized color and con 75 ppm 0 0 1 15 10 26 sistency changes N-02 ENDOCRINE SYSTEM Thyroid gland - increased in size Control 0 0 0 1 7 8, 0-01 25 ppm 0 0 0 0 0 0` 75 ppm 0 0 0 0 3 3 ADRENAL GLAND Enlarged - unilateral and bilateral Control 0 0 0 7 4 11 with or without associated color 25 ppm 0 0 1 6 2 9 change 75 ppm 0 0 0 6 2 8 J-01 Significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 0823.87 98- table 21 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Tumor or Tumor-like Lesions Grossly Recognized in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 13-13 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 ADRENAL GLAND (cont'd) Tumorous enlargement J-02 Control 0 0 0 1 0 1 25 ppm 0 0 0 1 2 3 75 ppm 0 0 0 2 1 3 INTEGUMENTARY SYSTEM Subcutaneous tumor - mammary and mid- Control 0 0 5 16 6 27 cervical region, number per rat 1 25 ppm 0 3 9 13 2 27 B-02 (1) 75 ppm 1 3 S 11 3 26 Subcut* 3 tumor - mammary and mid* Control 0 0 4 15 6 25 cervi region, number per rat 2 25 ppm 0 0 4 15 4 23 B-02 (2, 75 ppm 0 0 5 13 6 24 Subcutaneous tumor - mammary and mid- Control 0 00 2 1 3, cervical region, number per rat 3 25 ppm 0 0 5 6 2 13a B-02 (3) 75 ppm 0 1 0 8 2 11* Subcutaneous tumor - mammary and mid- Control 0 0 1 5 2 8 cervical region, number per rat * 4 25 ppm 0 0 1 3 1 5 B-02 (4) 7 5 ppm 0 0 0 5 3 8 Subcutaneous tumor - mammary and mid- Control 0 0 0 2 2 4 cervical region, number per rat * 5 25 ppm 0 0 0 i 0 1 B-02 (5) 75 ppm 0 0 0 2 1 3 Subcutaneous tumor - mammary and mid* Control 0 0 0 0 0 0 cervical region, number per rat - 6 25 ppm 0 0 1 0 0 1 B-02 (6) 75 ppm 0 0 0 2 0 2 Subcutaneous tumor - body/limb, number Control 0 0 0 0 1 1 per rat 1 25 ppm 0 0 0 0 0 0 B-04 (1) 75 ppm 0 0 0 0 1 1 Subcutaneous tumor - body/limb, number Control 0 0 0 0 1 1 per rat 2 25 ppm 0 0 0 0 0 0 B-04 (2) 75 ppm 0 0 0 0 0 0 Tumor of salivary gland region (sub- Control 0 0 0 0 0 0 cutaneous) 25 ppm 0 0 0 0 0 0 B-12 75 ppm 0 0 1 0 0 1 MUSCULOSKELETAL SYSTEM Tumor of the skull M-07 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 LYMPHORETICULAR SYSTEM Lymph node(s) - tumor consisting of Control 0 0 1 0 0 1 lymphoid tissue 25 ppm 0 0 0 2 0 2 G-03 75 ppm 0 0 0 0 0 0 Local invasion of tumor with regional Control 0 0 0 1 0 1 lymph node(s) involved 25 ppm 0 0 0 2 0 2 G-G4 75 ppm 0 0 0 1 0 1 dSignlficantly different from control data when analyzed using Fisher's Exact Probability Test, p<0,05. SL 082388v -99- table 21 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Tumor or Tumor-like Lesions Grossly Recognized in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months i i i 7-12 Months i 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 LYMPttORETICULAR SYSTEM (cont'd) Thymus - enlarged or enlargement In Control 0 0 0 1 0 1 region which thymus usually occupies 25 ppm 0 0 0 1 1 2 G-05 75 ppm 0 0 0 0 0 0 Splenomegaly - tumor related G-07 Control 0 0 1 0 0 1 25 ppm 0 0 1 1 0 2 75 ppm 0 0 0 0 0 0 EYE Ocular enlargement - possible tumor Control 0 0 0 0 0 0 C-06 25 ppm 0 0 1 0 0 1 75 ppm 0 0 0 0 0 0 Not significantly different from control data when analyzed using Fisher' s Exact Probability Test, p<0.05. SL 082389 -100- TABLE 22 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 1 i i 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 &6 16 84 LIVER Cholangloma H-49 Metastatic adenocarcinoma of utero-cervix region H-50 RESPIRATORY SYSTEM inaa Metastatic leiomyosarcoma of the uterocervix region R-33 Metastatic adenocarcinoma of uterocervix region R-40 Mecastatic adenocarcinoma of mammary gland region R-41 Metastatic osteogenic sarcoma of the forelimb R-42 Metastatic carcinoma of the thyroid R-43 Metastatic cortical carcinoma of the adrenal gland R-44 URINARY SYSTEM Kidney Metastatic adenocarcinoma of the uterocervix region U-15 Renal cortical carcinoma without metastacls - well differentiated U-16 CARDIOVASCULAR SYSTEM Heart Undifferentiated endocardial sarcoma without metastasis U-16 Blood Vessels Metastatic leiomyosarcoma of the uterocervix region - to several blood vessels C-46 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 15 ppm Control 25 ppm 75 ppm Control 25 ppm 15 ppm Control 25 ppm 75 ppm Control 25 ppm 15 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0 000 00 0000 11 0 00000 000 101 000 0 00 000 101 01 00 00 01 00 00 01 00 00 00 00 01 00 01 00 00 01 00 001001 000000 000000 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.03. SL 082390 TABLE 22 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 GASTROINTESTINAL TRACT Stomach Leiomyosarcoma with multiple intraabdominal metastasis G-10 Control 0 0 0 0 0 0 25 ppm 0 0 0 1 0 1 75 ppm 0 0 0 0 0 0 Small Intestine Mucinous cystadenocarcinoma without metastasis G-33 4 G-30 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Metastatic leiomyosarcoma of the Control 0 0 1 0 0 1 uterocervix region 25 ppm 0 0 0 0 0 0 G-32 75 ppm 0 0 0 0 0 0 Metastatic adenocarcinoma of probable uterine origin G-36 Control 0 0 0 0 0 0 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 Large Intestine Metastatic adenocarcinoma of uterocervix origin G-S7 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Salivary Gland Carcinoma most probably salivary Control 0 0 0 0 0 0 gland in origin without 25 ppm 0 0 0 0 0 0 metastasis 75 ppm 0 0 1 0 0 1 G-57 REPRODUCTIVE SYSTEM Ovary Granulosa cell tumor without metastasis X-62 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Ovarian adenocarcinoma of scleroei- Control 0 0 0 1 0 1 lng type with multiple tissue 25 ppm 0 0 0 0 0 0 mecastases 75 ppm 0 0 0 0 0 0 X-71 Ovarian hemangioma X-73 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Metastatic adenocarcinoma of uterocervix origin X-70 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Uterus Endometrial polyp formation X-77 Control 0 0 1 9 3 13 25 ppm 0 1 2 2 5 10 75 ppm 0 0 1 4 5 10 Not significantly different from control data when analyzed using Fisher's Exact Probability Test p<0.05. SL 082391 102- table 21 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm 0-6 Months i i i 7-12 Months i 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative mi Results 19 84 11 86 16 84 REPRODUCTIVE SYSTEM (cont'd) Uterus (cont'd) Endometrial polyp baaed on gross examination only X-101 Stromal sarcoma of uterocervix origin without metastasis X-83 Undifferentiated sarcoma of uterocervix origin without metastases X-84 Leiomyosarcoma of utBTocervix region with metastasis to lung, small intestine and blood vessels X-85 Adenocarcinoma of uterocervix origin with multiple tissue metastasis X-86 Endometrial carcinoma of the uterus without metastasis X-87 Adenocarcinoma of the uterus without metastasis X-88 Leiomyoma without metastasis X-89 Cervix - fibroma X-98 Scirrhous adenocarcinoma, origin undetermined, most probable ovary and uterine horn with wide spread abdominal metastasis X-100 Carcinoma of uterocervix with metastasis to abdominal viscera and one kidney X-99 NERVOUS SYSTEM Brain Astrocytoma N-03 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 00 00 10 00 00 02 00 00 01 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 Oil 0 00 10 1 0 01 0 00 0 00 0 02 0 00 0 00 0 01 0 00 0 00 10 00 10 1 0 1 10 1 0 00 011 12 20 00 3 2 0 00 00 10 0 0 1 0 00 112 Oil 00 00 10 0 0 1 00 10 00 0 1 0 112 0 00 000 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p^O.C SL 082392 -103- table 22 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm NERVOUS SYSTEM (cont'd) Brain (coat'd) Oligodendroglioma N-10 Control 25 ppm 75 ppm Metastatic lymphoma N-ll Control 25 ppm 75 ppm Pituitary Pituitary adenoma N-44 Control 25 ppm 75 ppm Pituitary adenocarcinoma without invasion of brain N-48 Pituitary adenocarcinoma with invasion of brain N-49 Control 25 ppm 75 ppm Control 25 ppm 75 ppm Adenoma based on groes examination only N-55 Control 25 ppm 75 ppm Total number of animals with a pituicary tumor Control 25 ppm 75 ppm THYROID Thyroid adenoma T-01 Control 25 ppm 75 ppm Thyroid adenocarcinoma without metastasis T-02 Control 25 ppm 75 ppm Thyroid carcinoma with pulmonary metastasis T-1Q Control 25 ppm 75 ppm Total number of animals with a thyroid tumor Control 25 ppm 75 ppm PARATHYROID Parathyroid adenoma T-25 Control 25 ppm 75 ppm 0-6 Months 1 i i 7-12 Months 1 5 4 13-18 Months 14 23 IS 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 000101 000000 000000 0 0 00 00 000101 0 0 0 0 0 0 0 0 2 20 15 37a 0 0 5 13 6 24a 0 0 2 13 11 26 0 00 1 01 0 00 1 12 000000 000303 000000 000000 000000 0 001 1 2 00020 2 0 0 2 24 15 41, 0 0 5 15 8 23 0 0 2 15 11 ZS 0 0 0 ii 3 14 0 0 1 9 3 13 0 0 2 7 7 16 000 1 5 6 0 0 0 0 0 oa 000101 000000 000101 000000 0 0 0 12 8 20 0 0 1 10 3 14 0 0 2 8 7 17 000000 000101 000000 Significantly different from control idata when analyzed using Fisher's Exact Probability Test , p<0.05. SL 082393 -104- TABLE 22 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Female Rats Number of rats necropsied during the time period indicated ADRENAL GLAND Cortex Adenoma of adrenal cortex A-25 Adrenal cortical carcinoma without metastasis A-34 Adrenal cortical carcinoma with metastasis to lung A-37 Metastatic adenocarcinoma of uterocervix region A-35 Medulla Adrenal pheochromocytoma, uni- lateral A-47 Adrenal pheochromocytoma, bilateral A-48 Total number of animals with a pheochromocytoma Ganglioneuroma - unilateral A-36 Pancreas Pancreatic islet cell adenoma P-20 Metastatic adenocarcinoma of the uterocervix region P-26 SUBCUTANEOUS TISSUE Subcutaneous fibroma S-02 Subcutaneous fibrosarcoma without metastasis S-05 Control 25 ppm 75 ppm 0-6 Months 1 1 1 7-12 Months 1 5 4 13-18 Months 14 23 15 19*24 Months 49 46 48 Terminal Cumulative Kill Results 19 34 11 86 16 84 Control 0 0 1 1 1 3 25 ppm 0 0 0 1 1 2 75 ppm 0 0 0 0 0 0 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 Control 0 0 0 0 0 0 25 ppm 0 0 0 0 1 1 75 ppm 0 0 0 0 0 0 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Control 0 0 0 2 2 4 25 ppm 0 0 1 3 0 4 75 ppm 0 0 0 2 1 3 Control 0 0 0 5 1 6 25 ppm 0 0 0 0 1 1 75 ppm 0 0 0 0 2 2 Control 0 0 0 7 3 10 25 ppm 0 0 1 3 1 5 75 ppm 0 0 0 2 3 5 Control 0 0 0 0 0 0 25 ppm 0 0 1 0 0 1 75 ppm 0 0 0 0 0 0 Control 0 0 0 5 1 6 25 ppm 0 0 0 0 2 2 75 ppm 0 0 1 0 0 1 Control 0 0 0 1 0 1 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 1 0 1 Control 0 0 0 0 0 0 25 ppm 0 0 0 0 0 0 b 75 ppm 0 0 0 1/1 0 1/1 Control 0 0 0 0 1/1 l/lb 25 ppm 0 0 0 0 0 0 75 ppm 0 0 0 0 0 0 Not significantly different from control data when analyzed using Fisher*s Exact Probability Test, p<0.Q5. ^Number of tumors/number of animals with tumors. 08^94 SI* -105- table 22 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Female Rats Number of rats necropsied during Che time period indicated Control 25 ppm 75 ppm mammary gland Fibroadenoma/adenofibroma S-25 Control 25 ppm 75 ppm Fibroma S-26 Control 25 ppm 75 ppm Adenocarcinoma with pulmonary metastasis S-40 Control 25 ppm 75 ppm Adenocarcinoma without metastasis S-27 Control 25 ppm 75 ppm Leiomyosarcoma without metastasis S-41 Control 25 ppm 75 ppm Carcinosarcoma of the mammary gland S-43 Control 25 ppm 75 ppm Adenofibroma based on gross examination Control only 25 ppm S-44 75 ppm Total number of animals with a subcutaneous and/or mananary gland tumor S-02, S-05, S-25, S-26, S-27, S-40, S-41, S-43, S-44 Control 25 ppm 75 ppm Number of rats with a malignant tumor in mammary region or skin S-05, S-27, S-40, S-41, S-43 Control 25 ppm 75 ppm MUSCULOSKELETAL SYSTEM Metastatic adenocarcinoma of the uterocervlx region to the mandible M-05 Osteogenic sarcoma of Che forelimb with metastasis to the lung M-06 Control 25 ppm 75 ppm Control 25 ppm 75 ppm LYMFHORETICULAR SYSTEM Mediastinal Lymphoid Tissue Metastatic adenocarcinoma of the uterocervlx region L-07 Control 25 ppm 75 ppm 0-6 Months 1 i i 7-12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 ii 86 16 84 0 0 17/10 78/39 37/15 132/647 0 2/2 40/20 76/38 16/8 134/68 1/1 6/4 17/14 100/40 33/15 157/74 00 00 00 0 0 0 0 0 0b 0 0 0 1/1 1/1 2/2 0 0 0 1/1 0 l/lb 000000 000000 0 0 0 1/1 0 X/1a b 0 1/1 2/2 1/1 4/3 8/7^*b 0 0 2/2 0 2/2 4/4b 0 0 0 0 0 ob 0 0 0 1/1 0 l/lb 00 0 0 0 0 0 0 0 0 1/1 l/lb 000000 000000 000000 0 0 0 0 0 0b 0 0 0 1/1 0 l/lb 0 0 10 39 16 65 0 3 20 38 9 70 1 4 14 41 15 75* 000 224 012238 00 2024 000101 000000 000000 000000 000000 000011 00 0 1 01 0 0 0 000 0 0 0 101 Significantly different from control data when analysed using Fisher''s Exact :Probability Test* p<0.,05. b Number of tumors/number of animals with tumors. SL 082395 106- table 22 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors in Female Rats Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm LYMFHORETICULAR SYSTEM (cont'd) Mesenteric Lymphoid Tissue Metastatic adenocarcinoma of uterocervix region L-31 Control 25 ppm 75 ppm Spleen Metastatic adenocarcinoma of uterocervix region L-50 Control 25 ppm 75 ppm Lymphosarcomas and Leukemias Generalized lymphosarcoma with multiple tissue metastasis L-63, L-65 Control 25 ppm 75 ppm Monocytic myelogenous leukemia with mutliple tissue metastasis L-64 Control 25 ppm 75 ppm Malignant lymphoma, primarily of mesenteric lymph nodes with intestlnal and brain metastasis L-66 Control 25 ppm 75 ppm EYE Retrobulbar fibrosarcoma without metastasis E-06 Control 25 ppm 75 ppm ADIPOSE TISSUE Metastatic adenocarcinoma of the uterocervix region B-02 Control 25 ppm 75 ppm MISCELLANEOUS Undifferentiated mesenchymal sarcoma of the mediastinal region with extension into the surrounding mediastinal tissue and vessels but without distant metastasis 1-01 Total number of primary tumors in the female rats as previously listed Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months 1 1 1 7*12 Months 1 5 4 13-18 Months 14 23 15 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 34 11 86 16 84 000101 0 00 0 00 0 001 01 000101 000000 0001 01 00 1 00 1 000 202 000000 000000 001001 000000 000000 00 0 101 000000 000000 00 10 0 1 000000 00 0 10 1 0 0 0 000 0 00 10 1 00010 1 000000 00000 0 0 1 25 149 73 248 0 4 54 119 43 220 1 6 26 137 65 235 Not significantly different from control data when analyzed using Fisher's Exact Probability Test, p<0.05. SL 082396 107 TABLE 23 VINYLIDENE CHLORIDE: A CHRONIC INHAIjITION TOXICITY AND ONCOGENICITY STUDY IN RATS Number of Female Rats For Which The Specified Tissue Was Examined Microscopically 0-6 Months 7-12 Months 13-18 Months 19-24 Months Number of rats necropsied during the time period indicated Control 25 ppm 75 ppm i 1 1 i 14 49 5 23 46 4 15 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 Liver Heart Kidney Lungs Pancreas Spleen Skeletal Muscle Mediastinal or Perirenal Fat Salivary Gland Aorta Esophagus Trachea Parathyroid Thyroid Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm i i i i i i i 1 i i i i i 0 i 1 1 i 0 1 0 0 0 0 1 0 0 1 0 1 1 1 1 1 1 1 1 1 1 1 1 1 0 14 49 19 83 5 22 46 11 85 4 15 48 16 84 0 14 48 16 79 5 23 46 10 85 4 14 45 14 78 0 14 49 19 83 5 23 46 11 86 4 15 48 16 84 0 14 49 19 83 5 23 46 11 86 4 15 48 16 84 0 14 44 19 78 0 3 2 9 14 4 13 46 15 79 0 13 49 19 82 4 23 46 U 85 4 15 48 15 83 0 10 46 18 74 i 12 22 9 45 2 12 43 16 73 0 13 47 19 79 01 2 6 9 3 13 45 16 77 1 9 44 17 72 o,, 2 0 7 9 4ii 11 39 16 70 0 13 42 18 74 0 1 2 7 10 3 12 43 14 73 1 12 42 19 75 3 15 28 6 53 4 9 41 7 62 i 12 49 19 82 5 23 45 11 85 4 15 47 IS 82 0 11 34 8 54 4 18 31 6 60 3 6 31 12 53 0 12 47 19 79 4 23 44 11 83 4 13 44 15 77 SL 082397 108- table 23 (Continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Number of Female Rats For Which The Specified Tissue Was Examined Microscopically Number of rats necropsied during the time period indicated Stomach Small Intestine Large Intestine Mesenteric Lymph Nodes Mesenteric Vessels Urinary Bladder Ovaries Oviducts Uterus Peripheral Nerves Spinal Cord Pituitary Gland Adrenal Gland Cerebellum Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months i i i i 0 1 1 0 1 1 0 1 0 0 0 1 0 0 1 0 1 1 0 1 1 0 1 1 0 1 0 0 0 0 0 0 1 0 1 1 1 1 1 1 1 7-12 Months i 5 4 0 0 4 0 0 4 0 0 4 0 0 1 0 0 1 0 1 4 0 2 4 0 2 3 0 2# 4 0 0 2 0 0 4 0 1 2 0 5 4 1 5 4 13-18 Months 14 23 15 14 16 IS 13 1 12 11 0 13 6 0 9 4 0 8 11 3 13 12 3 13 12 3 11 13 3 14 9 0 10 8 1 10 12 20 12 13 22 15 13 23 14 19-24 Months 49 46 48 Terminal Cumulativi Kill Results 19 84 11 86 16 84 49 19 S3 46 11 73 48 14 82 44 19 77 2 7 10 46 15 78 45 18 75 1 56 41 12 71 38 19 63 279 39 16 65 34 15 54 066 35 15 59 46 19 77 9 9 22 44 15 77 49 13 80 10 10 25 43 16 77 44 18 75 8 9 22 37 11 63 47 19 SO 10 10 25 45 16 30 39 18 66 077 35 15 62 47 19 74 06 7 45 15 74 40 18 71 38 11 70 35 15 65 48 19 SI 46 11 S5 45 16 si 48 19 s: 44 11 Si 45 15 79 SL 082398 -109- table 23 (Continued) VINYLIDEKE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Number of Female Rats For Which The Specified Tissue Was Examined Microscopically Number of rats necropsied during the time period indicated Cerebral Cortex Eyes Tongue Skin Mediastinal Lymphoid Tissue Clitoral Gland Mediastinal Vessels Pineal Gland Medulla Oblongata Regional Lymph Node Thymus Larynx Other Lymphoid Tissue Diaphragm Subcutaneous Tissue Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm Control 25 ppm 75 ppm 0-6 Months 1 1 1 1 1 1 1 0 1 0 0 0 0 0 1 1 0 1 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 7-12 Months 1 5 4 1 5 4 0 0 4 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 13-18 Months 14 23 15 13 23 15 10 2 9 0 0 0 1 1 1 12 1 11 1 0 0 1 0 0 1 0 0 1 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 19-24 Months 49 46 48 Terminal Cumulative Kill Results 19 84 11 86 16 84 48 19 82 45 11 85 48 16 84 40 19 70 0 10 12 39 16 69 101 0 00 1 01 5 6 12 0 34 0 79 46 15 74 2 58 41 12 68 001 000 101 001 000 000 203 0 11 102 023 004 103 011 000 000 000 000 001 000 0 00 101 000 4 04 000 000 000 101 000 000 303 SL 082399 APPENDIX I Individual Animal Data Body Weights SL 082400 1-1 The data presented in Appendix I are direct copies of computer generated tables for individual body weights for male and female rats from all exposure groups for this study. Before viewing these data, the reader is reminded that individual animal numbers were not assigned to these animals until they were submitted to necropsy. Therefore it is not possible to read across the table horizontally and trace the growth curve on any single rat with time. Animals decreased at the time of each weighing were subtracted from the total starting population (day 0) and are indicated by the entry "9999" in the appropriate column. SL 08240i 1-2 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY ANO ONCOGENICITY STUDY IN RATS Individual Body Weight Data for Male Rats orvuirvvu- iLn'i,uiTTi v^ n*ni\Lr rmyrum i iimun*i pynati n* 5W puucrmtu nn 11 mu n<jn<\ vi itwawatitiioa pyahtina a w wf*A*m I iwnnv tiitp ifiiv iv*naiuoiipu in rvm irrpfs iv kAvwvywy rnpM ai i i no// nuu aai wn attaini^uWLnuuiv.' 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W CAA A A V44 a VV / AO AA VV / 9 W Cl A AA VW 1 w COA AA V/V*vv C74 AA V/T a VV CAJ AA vv*** vv CAT AA vi / * w CAC AA V4Va VV CCA AA VW* vv / Art AA wv, vv CAJ AA WTa VV C 4 / Art ViVa VV 504.00 / A4 AA V4 i * W CAJ A A WT# VV COO AA V/ 4a W COO AA V/v*VV C 4 T AA Vi / a W CAA Art OUi a W CO/ AA WV* W 542.00 C 4 J AA ViTa VV / I A AA ViV* vv CCA AA W/.W CvvAA/ 1 AvvA w/ VVCAT Art , 414.00 4X.C0 COA AA WV* VV JAC AA T/V* W CJT AA VT/ a VV CTA AA V/Va W c/ J a A WTa VV CAA AA W4, W CTC AA v/ V* W 512.X CJA AA VT4a VV 577.X CT / AA V/ Vi W COA A A W/ a VV / / A AA Wv. vv CCA AA W4* VV / A/ AA wv. VV CTO AA V/ v. vv CAA AA JV4. W CAA AA VVV* W CC/ A A M'i Vv j A> AA T/V* W / AT AA VV / a W / AA AA WV. W CCA AA VW, W 544.00 521.X CAA AA VVV*vv / A 4 AA WiaVV COT AA V4/ * VV /A/ AA wv* W CAA AA V4V* W CCJ AA WT* W CJA AA V74 a W / A* Art V44 t VV 1-6 SL 082406 An ni oT nc wo 86 07 AA w 07 90 n4 /1 92 90 94 nc /o m /o 97 a/va on // .X ona AA JVT VV non aa 4>4* w ata aa 4/ 44 Vv 286.00 277.CO 266.00 275.00 230.X AAA AA 4VV4 w non aa 4/04 VV nnn aa 40/VV aaa aa 400* W W AA 4/V* VV ATT AA 4/ / . W aac aa 400* W AA/ AA 4VW* W non aa 6//tVV AAA AA 4U4.VV n n aa JlO* VV nc/ AA oovt vv ach aa OOT# S.A/ nnn aa O/ 4a VV Han AA TT/VV H An AA T4Vt VV ,* Cn a A TOOa VV 4TA A A T/ /* VV an/ A n TVOa Vv anc aa T/O aVV AAA AA OOW VV aat aa OO/a VV 315.X nnn AA OV4tvV 354.X 345.CO nnn AA ovoa vv nnn aa oo/vv nnn aa O/ Oa VV # AA AA tw vV HAA AA TV #a VV HAA AA TWa W H AC Aa TOO* W nnn aa o//vv a a. aa Toi.W ann aa TU41 W ni a An TVVa Vv * / n aa TV4a VV ann aa T/OaVV act An TOla Vv c*e aa oTOa W cn/ AA OOOa VV CTC AA O/Ot vv ann aa TOOa vv CAA AA OVV*vV ann a a 7/71vv 500.00 C / / AA OOO* vV 502.00 605.X 342.X 322.X non aa 04V*VV 325.00 AAA AA OVW. w nne aa 04VtVV 365.X 334.X A4A AA Vh/| Vv ACn AA OOO* W act aa oo/ vv nnn aa oo-o w A/ *7 AA OO/aVV 401.X 375.X Act aa O^.' 1 * Vv at a aa O/t*Vv atc aa O/ Oa vv 399.X /ana AA I4i> W X6.CC atC aa O / Oa VV nnn aa 0/4* vv HA/ AA TVVa VV HCC AA TOO.VV 435.00 *4 A AA TA / # W ann An T04 W HA 4 AA tVa.Vv 427.00 4 74 AA T/ *t. VV *fl( AA "TOO* VV 44( AA TTVa W 4 7T AA T4/a VV 4Ct AA TOla VV Hi* An TVTa VV caa aa OVOa vv cnn aa 04Oi w ccn AA OOOa W CA/ AA ovwvv aTA AA T/ Oa VV A~* / AA T/V * VV CT4 AA Oi 1*VV can aa 0T4vv an/ aa TVOa VV CCA AA OOOa VV an/ aa TvCa vv / nc V-ooi AvvA cna aa ovt* vv ^0007/ AVv'' Cnn aa 0/44vv CAA AA OvoaVV c/ n aa 0041VV C^~f AA 0//Vv CAA AA OVV* VV MA AA OlVa W CAA AA 040a VV lie aa 000* VV CAH AA OVTt vv / AA AA OVVt VV nnn aa 044* VV nnn aa W7 . vv 350. X 067. X AA * AA ownvV AC 4 AA OOl a W 401.00 nnn aa O / O a VV atc aa o/ o* vv an* aa TOTaVV a / aa TlU.VV 446.X 4 1 a aa TOTa VV can AA 014*VV GII AA OOOa VV C47 AA OT/ a W / / n AA 004aVV CAT 04/ a AVVA nnnn aa / / / /*w nnnn aa //>/* vV a*C aa OTOi VV nnn aa oo/vv /I An AA "TVOa VV H 4 T AA T4/.Vv 464.CC AT AA To / . VV ci n aa 014 a VV 9999.00 rwwt aa / / /7.vV 9999.00 nnn aa 0401 VV An/ aa 040t VV n< n aa Ol4iVV VO aa oot*vv nnn aa o/4 a VV nee aa OOOa VV n/ e aa ovoa Vv nnn aa O/ /t vv 357.X at/ AA 0/Oa W Ant aa OVA a W HA<f AA TVOa VV 99X.X 9999.00 AAAn AA //1fVV (VkTiO AA //7 71VV AWl AA >// 1aw n/n/n'/n.vava nnnn aa //it Vv 9939.00 nnnn aa .'///* vv 9999.X nnnn aa //?/a Vv 9999.X nnnn aa ///7.vV nnnn An // / /tvv nnnn aa ////vv 9999.00 nnnn aa 7///1vv nnnn aa ///7 # vv aot*t, vava n?n/n/n/.avav AOCaOO TAO tAVaaV 9999.X nnnn An 7 / / ? *Vv nnnn ////* avav nnnn aa 77//aW nnnn An / 7 >>Vv rvnr.n aa ////# vv 306.X 9999.X 9999.X 9999.00 9999.X nnnn aA ////.VV nnnn aa 7/7/vv nnnn aa /7//W nnnn aa /7//a VV nnnn aa /7/ t a W MEANS nTftirr>Ann 01 nfu/nfw r*r*i jt aTT Akin ut_vim iUao N* Ann c/ 404.00 t A A/ 14a OV nnn AA 04Wi4V 4 / AT iO. 04 ACA Cl O^OaOV n io. ti av ATC / 4 O/OtOi At CT 41 a O/ 396.02 A/ AA 4VaOO a aa nn TloaWO nn ca 4Wa OV aaT na TT/.67 AVAo o11v ann te TOO.IO at ni TOa Ol 513.94 45.X CAA ca OO/ a OT 47.14 ean at OT/a4/ /a A TA TV# 4 IX IX n/oo 99 99 n/oc o7eo 95 94 A4 /T nn /4 i ADJUST PACT 33 PRINTING HEAD ID iki AND PRESS: RETURN mi SL 082407 1-8 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Individual Body Weight Data for Male Rats nnr.r vn*ui*Ti Ao ratfa\it* Ai *nMn TklTil fT r.APA AA/^rt up'Ui Liiin / / / / -- u vi-mia tmr. iia? tirw i <i_mw uU*' *nwVk AirrirfAf Art M TAw-- tkH~' HATA Lu.no ntaiimuvi\ mwinu pmn rn rviN n^-n m/vw /m i aa aim atttaia ao Lavlvvwv i'iivii m_L. vAWvvi-m avmo nrto AA V* V flUtWAr nta u mv PA V/ OH 1 AA1 4V1 PM/ urt i AAA XV/ fIM/ Lff ! P1 A i.rf- pm* un i 219 A A1/ VA 1 AAP 4ta>b< Ln * A A 4.W AM/ yn t AP.P j^V/ PAN/ L*P l API OOi PAW LA 1 pap 070 PrtW Lf"J APC o/ o naw L'A 1 a aa TV;' i A p A O A P C O V P / rt V A / 1 A IV 11 4A 4X 1A 4V 14 15 it 17 1C 4 A A/ 20 AI X4 AA XX AA XO A4 XP AC XV A/ XV AP x/ AA XO 29 30 A* Oi AA OX 33 34 35 36 AP o/ AA OV AA O/ aa PV ai Ti 42 aA PO 44 ac PO 46 C/rt AA JlWlVV CPA AA O/ O. W CAP AA vv/ . VV l AA AA VXO* VV / AA AA VXV * VV / /A AA VPX* W CAC AA OV.'l VV /CC AA WO. W CAH V OVP, W tcc.oo tC2.CC CC/ AA OOP VV / AA AA uxv. vv Cl A AA OW VV /lA AA Vi4l W 540.00 Z 1 A AA uuiVv /Cl AA WA * vv /A* AA U41 VV Cl A AA OW. W 4tl.OO / CA AA UW. VV 51t.CC AA i AA WP* VV CCI AA OVA VV 55C.C0 506.00 CAP AA o/o. vv CAA AA oxx.vv /rtrt AA ooo.vv 550.00 556.00 606.00 640.00 577.00 560,00 575.00 667.00 rac aa opo* vv / AO AA OOO*VV 607.00 474,00 SCO. 00 CA4 AA OOi.VV 561.00 600.00 CTA AA V/ Vi W CPA AA OXO. W CA / AA ow* W in < aa t/p a . vv / pa aa 04.fi VV / I 1 AA UlUiVV Cfn aa v / /VV C7/ ,AA V ! V *VV / IP AA vrv. vV / AA > A OXX* VV / 1 C AA U4WIVV CAP AA v/ / * w C/M AA OP AVV 604t00 CAP AA J4.4iW C# A AA ow, vv 601.CO 645.00 565.00 4 1 ft AA VAV. VV 463.00 649.00 516.00 / AC AA wo, w CAA AA WV. W SCO.00 542.X 547.X 550.X / Aa AA OXPvv 550.X 519.X aCA AA POX.vv a / c aa PvV. vv CAC AA OW. vv CCC AA Ovo,vv cpc aa o/ 0.vv 642.00 559.x 640. X /e/ aa Ooo. W CC4 AA OOil vV CA4 AA OX4 a W a/a AA PVOi W 574.00 543.X CAA AA ow. vv C^A AA OXX.vv CPA AA v/ v. vv < CA AA V.`V * W / A/ AA VXO.VV {A* AA VXP. VV / / A AA wx VV CAA AA h'>4|W CAA AA >V4. VV /fl AA V/11VV / Af AA l*ov. vv CCC AA w'OO. vv / AA aa OV/ . Vv 1 *, C AA viv.vv Cfl AA V/ AVV 541.00 /If AA V A 4 iVV CAA AA WX* VV 560.00 596.00 / art aa OPV* vv 479.00 464. CC C1 4 AA Jiiivv t* a aa OiP. w CA4 AA OOliVV CC4 AA OOi . W 5X.X 572.X CAA AA oo/vv aAP aa p//vv 5C2.X / AP AA OX / i vv 645.00 565.00 / a a AA OPP. w acA AA POO.vv / Art AA ov/.vv / A/ AA ooo. w / C/ AA wo. vv 550,00 / Art AA OoO.vv a / A Art pw, vv CAA AA oox. w 541.x CAP AA OX/ f VV CPA AA O/ VI W CAl A A oov. vv CIA AA JIUiVV f AA AA VOX* VV / Af AA VXV * VV 1*1. AA U*fVl Vv 660.00 CA 4 AA J/llVV CA* AA WP,VV 1 7 A AA V/ V.VV CAA AA V / 4. VV I AA AA wvvv CAP AA VV/ i w CA / AA j/VlVV CAA AA OXX. VV 1 A / AA WUiW CaA AA OPO* W C/ A AA OW. vv CAA AA OOV* W C/ A AA OVV* VV I AA AA VXV w 460.00 413.00 491.00 CAP AA VX/ a vv CAA AA OPV* VV / AP AA vv/* vv C74 AA oop, vv CAA AA ox/ vv 402.00 C/A AA oo/vv 499.X / A. AA 0X4.VV 641.X 440. X 632.00 6X.CC 561.X caA AA OPV, w / art rtrt OPV. vv / IA AA i/PX. w 657.X CAA AA oV/* VV c*a AA OPX,vv Cl A Art OW. vv ac/ Art POO.vV CA/ AA VvV i W CA * AA J4,fiVV CAA AA v/V* VV / I A AA UAV.VV /A/ A* Vv'V 1 VV ( CA Art wv# vv t AA AA UWi vv 592.00 17/ AA V / Vivv t TT AA v//vv / AA AA w CC / AA vwi vv 605.00 /pa aa UAtVV CAA AA V/ i. VV CA/ AA VPViVV tAP AA Vi./ . VV CCA AA VvVi w C7A AA V/vvv CAA Art vW VV / f AA V7/ w *f>A AA P/ 4.1 V\< 47 / Art f/ui w CM AA J11iVV M A AA VIV*VV CAa a a WP. vv Cl A Art ooo# vv 494.CC ca / Art OPO.vv CP 4 AA O/ ia VV cca AA OOP,vv 510.00 654.X X9.CC 460.00 / aa Art wx. vv CAC AA wo. vv /a/ Art OPV.vv CPA Art O/V. vv 646.00 603.00 / PA rtA o/ v. vv CAa ' OOP. W' 473,Cv 520.00 C/ A Art oOo. W ci a AA JTT| VV CAP AA v * / VV CCA AA WVt VV ( AA aa vvv.vv /pa aa v/7|VV / CA AA VVV. vv / Art AA VV4.vv CAA AA v-' * vv PAA Art / V4.I VV / AP AA V/ /vV / AC Art vw* vv CPA AA v//vv /pa AA t4P. W /aA aA U74. i VV / A 4 AA V\' CAP AA taV"vv aAP AA Pv/w / PC AA V/V.VV / a A Art VPlfci vv /CA Art Vi.*V vv / / C AA Vw vv CA4 AA Wi vv Cl 4 AA viivv CPA AA v//vv CPA AA v; v* w CAA AA V^/| w CCA Art oov* w 645.00 417*00 CAP rtrt ovx.Vv / A4 rtrt w*. w CPA AA o/ v. w WU.00 /AP rtrt w/ VV 593.00 //>A AA wx* VV a PA Art P/V,vv C4A Art OP/t vv 605.CO 661*00 l CA Art wx* vv CAA Art jwi w 564.00 617,00 car aa opo,vv / A4 AA Jiii vv CCP AA vV/ i vv / AC AA VV<J vv CrtA AA w/ i vv / e-r aa V*v/ vv 1 AA AA V/ViVV / A` Art V*V# VV / 4 A AA yUiW PI 4 AA /la.vv / 4 A AA VI/VV /CA AA WV| w / AA Art U4.W 1 VV CAA AA VW VV / AA AA WVi w /AC AA VWiW CA4 AA OV1 W /CC AA wvi vv i ap aa VfJlvv /AP AA LrtJ/ VV am AA p/p*Vv 665.00 CAC AA wo* vv f/c AA wvivv CAC AA ji.vivv CAC AA AW vv CPC AA o/o.vv CAC AA ooo.vv / / C AA oW* VV cap aa OP/.VV Crt* AA OV4 W CAA AA oxv.vv / AP AA WO/*VV CAA AA w/.w 672.X /. A/> rtA w/. vv 603.00 670.00 617.00 aAP Art PV/ W 557.00 CA* Art O/i.VV / / A Art Wo. v*v / en Art w/ * v*v CPA Art o/ /. vv / AA AA Oxx*vv C/A Art ow. vv 640.00 / AA Art OX,/ VV CPA AA 0/V# VV CCA AA OOA.I W PAa AA /vpivv / / A Art ooo.vv / / / Art wv vv / Ac AA oxoi w PAA Art / ov. vv / AA AA vxo.vv / / a AA wt.w / AA rtA uvki w / 4 A Aa yiviw / AA VS/V VV / CP AA oo/ w It A AA OOOivv CA/ AA o/o.vv P/A Art / IV. W 629.00 a aa Art p/o* w / A. AA O/ i * W ` PA Art V/ Oi VV CCA AA oov. w CoA/AxvAA^ CAC AA OVO.VV crv> a a O / /1vv cap Ai* opo. v\' / ca rtrt OOP * vv C/ A rtA ovv.vv cap Art W/. vv aAc aa p 'O, vv CA/ Art o/v*vv zap AA vp/ivv /PA AA v/ x vv 717.X 704.00 / 4 A Art V4X, VV CAA AA wv* vv / A / Art vxv* vv a AO AA P/V. W / AA Art wo. w Prt4 rtrt /Vi* VV /PA rtA v/ o. w / HA Art OPx* W cpp AA o/ /,vv CAC Art O/O* VV / PA Art V/ V,W /CC AA ooo. w 717.00 / 4 A AA o1v * vv CA* AA O/1.vv C/ a A A ovx.vv / AA Art Ovvvv / ac aa opo.vv pap aa / TO. 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W PIP AA dTd* W Curt AA dTd* vd CCrt Art vv/vv 1 rtrt aa d/v,vv / #rt Art div.VV Art A/ CArt Art Mi Vv C'Vrt AA ViVi W CAT AA vv / VV 4AC AA 7\Wi W 4rtrt AA T//* VV C^rt AA dsrt/ VV Crt/ AA ddd.VV CT* AA d/ T,VV C**>l /rMt AA VV / ' * AA Wi* vv 7A4 Art ddi# VV AA dV CAT Art w / vv Crtrt AA vvi vv CrtC AA did, W C4T AA di/VV Crtrt AA Vi/ * W Crt/ AA did.VV Crt; aa ddd*VV Crt/ AA ddd. W CTA AA V/ViVV / rtT AA di/ VV / rtT aA dd!1VV rt, di 0f\r> aa nwiw #HA AA TWVV 4 #art AA 77 / W CAA aa ddii W CdT47/ * AVV^ Crtrt AA dvd,dV Crt / AA ddd,VV C/ T AA Vd/ i w cdC/rt# * Art w / rtrt AA dii.VV / 4 rt AA UTi.VV Art di Crt/ AA Vi.Vi W CAC AA dw * vv CTA Art V//VV C4rt AA dT/*VV 555. CO C4 C AA did.VV CJA AA dTd.VV CCT AA dd/ * W Crtrt AA VW. VV / #rt Art VTV, W / / rt AA ddd, W rtrt dd CAt Art VV/.VV 503.00 C/ rt Art Wi, VV 4 rtrt AA Tii* W 567.X Crtrt AA did w / AC AA VVd. W CCrt AA ddd,VV 640.X I CT AA VV/ , vv O/AV#T,dAdA 34 #rt4 AA TV 1 * VV nrv^ M W pci Art VVTIVv Crtrt AA JiVaVV a *c aa TTd.VV CAA AA d/Vivv 550,00 634.X 665.X CA 4 AA dVi W 402.X AC dd 515.00 523. CO 611.00 crtrt Art dii,vV 533.00 /Art AA /rtrt AA / rtrt AA eA* /y\ / Art AA V*Vd * Vv dii,Vv 4kx.*. vv ddi* w di/,VV / / rt AA vv rOt/v 501.00 495.00 566.X Crtrt AA dii* VV 531.X 535.X 600.00 63C.X Crtrt AA d/d, W / > rt aa Wd, w 1 CC AA ddd,VV rtT d/ Crtrt Art dVi, VV 494.00 544.X 533.X 535. X Crt AA dTd. W 572.00 Crt# AA ddT. W / , # rtrt ViT, W CCrt AA ddV, W /rtT AA di/add Art JU 501.00 554,00 563.X 570.X e*rt aa dTd*VV 554.X CCA AA ddV. W 599.X / rt/ AA Vdd* W / T/, aA did.vv C#rt AA dT/,Od 3? 575.00 etc i"in 522.X 497.X CCA AA ddd*VV 6C6.X CT/ AA d/da VV 636.X 5X.X d/rdtrdt . AVAV 651. X 40 545.00 494.00 532.X cert Art dW* VV 540.X C/rt AA dW.VV 617.X CArt Art d//Vv 656.X / *rt AA dTd.VV 602,00 41 564.00 535.00 553, X 535.X 577.X 473. X 492.X 521.X X7.X 574.X 654.00 42 503.00 593.00 583.X XI.X 543.X 491.X 507.X 630.X 632.X CCrt AA ddd. W 623,00 #rt Td 493.00 500.00 541.X cert Art dddi W 577.X 599.X CA4 AA iVlaW 524.X 547.X /Trt AA di/dv TrtA AA /iVtVV 44 575.00 439.00 Lt 'rWvtrVV CA 4 Art dVT*VV 623.X 575.X 606.00 X3.X 611.X 71C.X 556.00 45 592.00 463.00 552.X 532.X 523.30 554.X 526.00 537.X 547.X 673.00 c/ AA dOi, VV 46 535.00 591.00 616.X 592.X 619.X 501. X 509,00 606.00 624.X 543.00 / T4 AA v/ i, vv 47 456.00 539.00 513.X 463.X C<T AA dd/ * VV 579.X 591.00 623.X 6X.X 577.X CC# AA ddT* VV 43 476.00 450.00 567.X 552.X 540.X 497.X 572.00 6i4.X 539.X CAT AA d// W Crtrt AA d/d, W 4? 555.00 555.00 535.X 514.00 470.X 615.X /rt* AA ddTa VV 531.X 599.X CTA AA d/V.VV / A4 AA VdiVV 50 513.00 524.00 621.X 550.X 496.X C/, rt AA ddi, VV 514,00 595.00 695.X /A/ AA ddd.VV Crtrt AA dd/* W 51 IVTX* AVt AA VV 562.X 633.X 535.X 550.X 513.X 627,00 V1 T#rVt . Wrtrt 633.X X2.X 601.00 52 543.00 5C3.X 515.X 479.X 601.X 610.X CTrt AA dii, VV 531.X c/rt Art dd/vv CTC AA di d. W Crtrt AA dd/,vv S3 549.00 577.X 597.X Crtrt Art d?i. W XI.X 515.00 cy* AA d4/*W 543.00 546.X /.rtrt AA ddd, W / rt4 AA ddlaW C dT 406.00 583.X 6X.C0 CCrt Art ddd, VV Cl H AA JvTaW Crtrt AA ddd. W C4 / Art did,VV 542.X 556.X 623.CO C/rt AA dd/,VV 35 556.00 540.X 593. X CA* AA dVT, W C4rt AA dTd, W 511.X dCd/ T* , wAA 533. X 579.X Cl rt AA Vddi vv /AC AA did,VV 56 575.00 49C.X 559.X Crt/ AA did, W ere AA d/d, vv Cl A AA ddV,VV C*rt AA dTd,VV C / / rtrt ddv,vv Crtrt Art Vd/ * W Crt i aa d/ia VV Crtrt AA d/i, W CT d/ 534.00 531.X 570.X 553.X 521.X CrtA AA diV* W Crt* AA ddT. VV / , rtrt dii,VV 543.X 636.X / 4rt AA Oid-VV 53 501.00 476.X 523.X 523.X 499.X 537.X 6CC.C0 5X.C0 594.X Crtrt aa dOd,VV CT t AA d/d*VV rn v1/ 536.00 519.X 511.X 434.X 549.X 557.CO 564.00 CJIrt rtrt dTd, VV I A4 Art dii.vv / C4 AA ddiivv / C AA dTd, W 60 514.00 549.X 647.X 461.X 470. X 519.X 579.00 Crt i rtrt d/i,vv X6.X / #rt AA dTd,vv / rtrt aa did,Vv 61 561.00 557.X 533.X 600,00 / , / AA L/i V, VV CTrt Art d/i, VV 536.00 542.X CC/ Art Vdd. W C4 rt AA did* vv Cddrtd/ * aVV/ 62 531.00 518.X f AA JJC. VV 5S7.0C 523.00 567.X CTC AA d/ d* w 536.00 cm AA VO/ w / rtrt AA ddi,vv TAC AA / id* W 63 504.00 501. X 556.X 504* 00 610.00 era Art d/ 4,VV 594,00 / Ai Art WT VV / Art AA dVv, W / * * Art VtT. w CTrt AA d/ d,VV 64 607.00 613.X 640.X 50C.C0 526,00 Crtrt AA ddd,Vv C/ 4 AA ddi VV rdedd/ * vrtvrt /rtrt Art did, w CTA AA d/ViVV / #rt AA dTd, W 65 503.00 477.X 591.X CAT Art JV/ * vV 590.00 551.x 604,00 / Art rtrt did, W C/rt Art vd/, w / rtrt AA did, w dl rdtT/,VAVA 66 546.00 494.X 623.00 Crtrt AA dw, w C/rt AA JW,VV 607.X / rtT AA Vi/.VV 633.X 646.X 625.00 d/ T#T# ,VAVA 67 501.00 Vr'Vu't Oaav 621.X 576.0G 574.00 6X.X *rt< AA T/i,VV 536.X 627.X 5X.X 4 AT AA Td/ t W 63 566.00 eMr 0i AVAV 603.X 625.00 605,00 401,00 600.00 /rt/ Art did,vv C*rt Art did, W 4CC AA Tdd VV CC# AA ddT* VV' 69 523.00 496.X 591.00 505.00 654.00 595,00 i-04,00 / rt/ AA did. W / />C rtrt Odd,VV #rt/ AA Tid# W #rt/ AA TW* W 70 504.00 CrtT AA dd/,Vv 595.CC cc/ AA dWl W 605,00 579.00 / 4 * AA tiT* VV C / A AA dd/ W CA 4 AA ddi VV #T# AA T/T,VV rtCA /\/\ ^SJii s/v 71 435.00 536.X 622.X C4rt AA dT/ * W ere Art d/d* W 555.00 CCA AA dd/.VV 616,00 631.X Tf / AA /id,vv TrtA AA /dV*vv 72 544.00 550.X 540.X 576,00 CCA AA dd> W 550.00 571,00 C* 4 AA VT* , VV 550.X 614.X 1 4 rt AA wi/vv Art /d 543.00 #Trt AA T/>iVV 537.X CAA Art vw vv 564.00 606,00 553.00 Crt/ AA Vdd, w 529.X g/ /wrt, WAA / 4 rt aa did,vv 74 etA AA VV Crt4 AA Wit VV 607.X 552.00 501.00 CrtC Art did. W 527.00 532. X XI.X /rtrt Art ddi.vv II, T AA dd/ * w 75 534,00 562.X ut ALf^ . Art VV C4C AA dTdiVV Crtrt Art did,VV /rtrt Art Tid, W A Art AA ^Krt/a VV T*/w/d,Avvrt T/ T Art dW, dd 666*00 1 rt/ AA ddv, w 74 /d 536.00 543.X ere aa cue AA dTW.VV 592.00 TSJVrdt .VAVA 459.00 #AT Art Ti/ , W I Crt Art Tdi*Vd 611.00 / rt AA did,vv 77 // 595.00 556.X tAA Art V^V.VV CArt Art dVV* W C/ / AA ddd. VV 574.00 600.00 / Crt Art ddi. VV 675.X 741,00 T#rt AA /Ti,VV to 40 554.00 (4rt AA did. VV err aa JtVi Vv 570.00 CrtT Art di/.VV Crtrt AA d/d* W 606,00 650.X Crtrt Art v/d, vd T4 rt AA / id, w T1 irdtrt*vAVA 1-10 o rv 03 o ftft 1y so ft4 Vi rtrt V4 rtrt w ft* VT rtC w rtf w rtT V/ Crtrt AA V4V* VV CH AA W/ VV C4rt aa VTV. w 560*00 500.00 520.00 CArt AA VVV. w 414.00 Mftft AA TW* vv C"*A AA Wv f VV C*ft ftft Vtv* vv CAT ftft vv/vv Artrt AA Ty4,VV 1 t ftft **i i * W CCrt AA w/ vv *rte AA T/ v# w 501.00 rtrtrtrt AA y * f/ .w Cftl ftft v yv *vv Crtf AA WVw vv CCC AA vw* vv CTrt AA J / /. w 022.00 423.00 artrt Art t/v. w rt/W> AA //>/VV wrtrtrtrt AA ."` y y y1 CCA AA VVV t vv HOA AA T//VV CArt A A VV/1vv Cftl ftft vw* vv 571.CC Crtrt AA V4V. VV M At ftft TTTt VV *4 AA T i T vv rtrtrtrt A A y y * VV CCA A \ VW. VV C4 j AA VIV* vv Crt-* AA vv/*vv CArt AA Vw VV CrtA AA V4V * w Ci ft ftft VW. Vv rt / n AA wt * vv rtCrt AA vw. w rtrtrtrt A A ` / / ' %VV cr.rt A A VW. VV CTO AA V/ V* vv / / rt AA vw VV* ct* ftft V/ TiVV / Art AA VV4. VV CC/ ftft WV* w * ae aa V"Tv VV rtrtrtrt AA / / / i vv rtrtrtrt A A / / / / t VV Crtt AA Wi * VV Crtt A A J,'W( VV CAST AA wv* w / -ra aa V/ *T. vv / in ftft vw. vv CTrt AA V / / *VV (H AA Vi1iVV rtrtrtrt AA //>/Vv rtrtrtrt AA ,' / y vv Crtrt AA v/v*vv > AC AA V/V* w /rta .aa V4T W / Art AA uv/vv Crt / AA V/v* vv ' rtrt AA VVUi w / rtC AA vw. vv rtrtrtrt a a /ft/vv rtrtrtrt AA ////%VV TArt AA W. VV / Art AA UV/VV f rtrt AA vw* vv 1 rtrt AA vw* vv Crtrt AA VW. w f rtrt AA VV/ VV Artrtrt AA W rtrtrtrt A A ,t / f / % vv rtrtrtrt AA ////.VV rtrtrtrt A A /y * > tVV rtrtrtrt AA / ///W rtrtrtrt AA ///* VV rtrtrtrt AA ///ftVV rtrtrtrt AA 'J / / S 4 VV rtrtrtrt A A ,// ' y t\/v rtrtrtrt AA ////VV rtrtArt aa //.>/ vv rtrtrtrt aa /y ' y tvv Artrtrt aa ///# vv Artrtrt AA , ti/,VV Artrtrt AA ////* VV rtrtrtrt AA y t y / % vv Artrtrt AA y t ' / vv rtrtrtrt aa / / / vv rtrtrtrt A A y *yy9w Artrtrt AA ////VV Artrtrt AA // ` > 9 VV AV^tAnkilmyAnrn>uri liKAlp-f.lnTnATi T4v,'><fcwA tc V4V. IV ftft eft V/.VW e^rt ca V4V.VV ** ftft Ti i VV c/rt 4 a WV.4 4 m ft c/ TV.W nrte VW.Vi. it a in ^VilU cra At JW*Vi at T/ i 4* 11 art Ct TV.Vl Cl ft ft/ W/.W fft ftft Tv./V Cftl ft* WVWt'.'^ a ft f ft ^V*W Cftft 1 V/V.iT Crt Cl, W.W 14* ftft UlliV'4 Cft ~*ft V/./t lift M *7 VlV.Tf -JA ! ' /WW ."vc rtf w vv ft/ nc nc rvc pa ftft VV V<J VV VV VT V 1 eA< aa Wi*vv CrtC AA V/ V* w f Art AA Ovvivv f rt* AA vv*.vV i ftft ftft wv* vv util V*t 1 ' AA v^v vv A Crt AA Wi. vv C/C AA vw. vv CrtC A A v/vi w TArt AA 1VI.VV A Crtrt a a C 4 / ftft Cftl AA er.n A A 14* 4. <j7 i # vv -4V* W wv> VV w`V 1 */V 1 rtrt AA vw. w cec aa wv. vv Crtt AA Wi VV /Crt AA W/ w rtAa AA /Vrt.vv /1 rt aa Vi 1 vv A Cl 4 AA Crt ft rt * Cftl", A A crt a a A Cart aa CC/ AA / rtrt AA / / AA / rtrt aA 1 ft/ AA / *rt AA V Virt.vv ' V* Vv w * 1 VV V / " vv vrt^.. w VWa VV Vii . W WV. vv WV* vv V4V.VV VT4(VV C / rt f ft w'Vt# VV C* a a a *Urt, VV Crt/ A A wv* w ca* aa vv Crtrt AA vw. vv cca AA w*V"T. vv CCA AA VV/ w / * rt AA Vi*. W Crtrt AA wv. vv / a-T AA V'f 1 . VV 1 CT AA w tvv c Crtrt AA Crta aa Crt / AA crtrt aa Crt a AA / Art AA Crtrt AA e / a aa Crt/ aa / t / AA Crtt AA V WV W vg*r# vv V/V.vv V4>/ VV V4T# W wv. w VV/9vv wv. vv V/v.vv ViV* vv Wi . W 0 C 4 C ftft viVivv Cl ft AA vw* w ct f AA V4V* W Crtrt AA vi/* vv Crtt AA VVi Vv Cat aa 1.W Crtrt A A v>/.vv Crtt AA V/ 1 t w / * rt VIV*vv C' A AA WV. w 1 A AA WV. W rt Crt/ AA artrt aa CArt A A artrt aa caa aa CrtC AA ret a a CAA AA C/A AA / rtrt AA Tt rt AA / yiVtVV rt/*#vv VVA. w rtV/ . w vyv.vv vw. vv Wit vv Ui/.vv WV. VV V4-/.VV / 44.VV rv V art/ AA rt?V*vv 495.00 Cft* A A VV^. VV Crt a AA Wrt VV CrtA aa v^/ vv Cart ftft util w Ct rt AA via., vv c/ rt AA VW. W 525.00 709.00 027.00 A / art/ aa rt/v w Crtrt AA VV4*vv CrtC AA VW* VV CAC AA ,`VV* vv 492.00 CArt AA UVi! W 521.00 Cft ftft VrtV. VV 535.00 Crtrt AA V/V.Vv /AC AA WV. VV 4A iv Crtrt AA V / </ * VV 531*00 032.00 / rtrt Art V*/*vv 017.00 Z AC ftft VVV*vv 610.00 / / 1 AA Wrt. W /ftft ftft VAV. w /At AA Wi. W / rtT AA V4/*VV 4 4 /art AA f rta AA Crt^ ftft 590.00 595.X CCC AA / Art AA Crtrt AA 590.00 a A .t AA CAT AA ii OiV. W w^*vv W/ . Vv vw. vv W/.W WU* VV rtvrtivv w / *W 12 520.00 537.CO cart Art v-TV* VV 540.00 CCA AA wv. vv / art aa VT*U. vv CCrt AA w/vv 1 art aa vrti,* vv 050.00 art/ aa rt/v* w 1 a a aa TTT. VV 13 514.00 516*00 Crtrt AA vv CrtC AA va>v* w Crtrt ftft V4.U* VV CrtA AA U"W w CC/ AA VW. VV CrtA AA w/v. w Cart aa Vrt/ w Crtrt AA V4/ . W artrt AA T/ViVV 14 CrtC AA Crtrt AA CrtC rtA Crtrt AA Crtrt AA CCA aa cart aa Cl rt AA CCrt AA rtf t AA arte AA v*4V* W v^w* w V4.V. VV vv / w vw. Vv WV. Vv vrtv. vv Wi, vv VW* W Wi. W T4V, W 15 C< / AA ViV*vv Ctrt ftft vii w Crt < AA joi.vv 519.00 Crtrt AA vw. vv Crtt ftft W4. w 557.00 566.X 574.00 1 AA AA vw. w z AT AA vv / * Vv 10 f AC AA vvv*vv 421.00 407.00 CrtA AA VW. vv arte ftft ^t^v. vv Crtrt AA vw* w Crt a ftft *,*vrt. w CrtC AA VW. vv 501.00 ii* ftft Wrt.V'V /Ta aa V/T,VV 4/ Crtrt AA w/ t vv a Crt aa rtW* VV 535.00 arti aa rtxv.Vv Crtrt AA w / . VV 413.00 aat aa rtrti. vV a *c aa rtrtv.vV act AA rtVl.w / / C ftft vw. vv / AA AA wV. VV IS 19 20 A4 4-i rtrt 4^ rt#rt AA VTVtW 403.00 Crt < AA 064 W 537.00 549.00 540.00 596.00 535. X Cl ft ftft W/ vv 577.X 40C.CC a / c aa rtw. Vv Crtrt ftft wwwiVv 570.00 CCrt AA Wi. VV 407.00 514.00 514.00 543.00 a/ aa rtrtv. W a art aa t4v. w rt-*A ftft v/ V. W 544.X am aa *Km . vv CArt AA vv/. w a art AA mivv artrt AA TV/ . W 571.00 Ct A AA ViV.vv rtT4 ftft A/T.VV a art aa rtrtv.vv 546.00 rtrtt AA Wi* w Crtt AA v/Vi vv cart AA vtv1vv artrt aa rtw* vV artrt AA rti./ w / rta AA v^rt.vv C/rt AA w /. vv / * * ftft Oirt. w a AA AA rtVV. W atA aa rtiA.VV Crtrt AA v/ V. VV / rta aa Wrt. vv /rta aa Wrt. W / a a aa VTV.VV / Af AA Wrt. w C/A AA WV. VV / AA AA WV. W Crtrt AA w / VV /at aa VT4. W / 4 A Art ViV.vv C/rt AA VW. VV Crtt AA Wi VV Cftl ftft /V.vv 23 530.00 cca aa v^rtr* vV 503.00 Crtrt AA VW* vv Crtt AA vvi. vv Crtrt AA JViiW 515.00 Crtrt AA V/ V. w Crt/ rtrt v / v * VV Crtrt ftft wv. w TAC AA / w. vv rti AC Aw* C Art AA VVA* W Crtrt AA Wi-i. vv 603.00 453. X 019.00 Crtrt AA wv W /At AA yVl.VV 505.00 Crtrt AA W4* vv 535.x Crtrt AA VW.VV C/C aa vw. vv Crtrt AA uu.w CA*V AA V/V.VV Crta AA V/rt.vv ertrt aa w/ . w ca t AA Vrti.vv / t rt AA Vi V. w CrtC AA wv. vv / Crt AA w /.VV / /rt AA Wi- vv CrtC AA WV. VV rt/ 000.00 Crtt AA V4.1 vv 535.00 535.X arc aa 7/J.VV ct * AA Vii* vv Crtt AA v^ i. vv CAa aa vvrt. w / a a ftft vrtrt. w 003.00 / rtA AA wv* vv rtrt CCrt AA crtrt Art 459.00 6X.X Crtrt ftft crtrt aa aC / AA III ftft Cta aa Crtt AA ^rtt AA 4./ VV VV wa. vv vv/tvv tw. W vw* vv virt.vv W i * W / Ji1VV 23 407.00 Crtrt ftft v/ /.vv eart Art Vrt^* vv M fft AA rtWVi w /rtrt ftft V^v.vv Crtrt AA Vu-tVV Cl A AA Wv. vv Crta aa v/rt.vv Cl t AA Wi VV "* Art AA / VV.VV i ft4 ftft wi * vs* 29 032.00 516.X 003.00 529.X Crtrt AA Crtrt AA c/ a AA /rta aa cart AA Crtrt AA / / rt AA ViwiW V//.W Wrt VV Ui.rt vv Vrt/. vv w /. w WV* VV 30 532.00 535. X 553.00 014.00can aa vrt/vv ac-7 AA fv/9vv a / rt /\a rt'*'/ * W Cl A AA Wi.. vv / t rt AA ViV* VV I art aa VTV.VV / art aa VT4.VV 31 425.00 553.00HCrt AA rtOitW CrtC AA vt-*v. W C/ rt Art vw. vv Cftl ftft VW. VV CArt ftft VVjL . vv CCA AA wv. W /.rta AA Wi.W / rtrt AA V44. W 1Cft ftft w/ vv 562.00 532.X 537.00 567.X 510.xArt V/L CrtA AA v/v.vv / t rt AA Oiv. W / rtrt AA VW* W / rtrt AA VW. W /Crt AA W4. VV fft* ftft O/T. W 03 547.X 563.X 577 X 476.XCrtrt AA w 49S.CC Crtt ftft Wi . vv arti aa rt/T. W Crtt AA VVivv //ft Aa w/ w / t T AA Vi / W 34 623.X 539.00 577.00 500.00 rtCtC AA wivivv artrt aa rt// w C* rt AA C^fft ftft ViV*VV vw* w artrt aa / /W Crtrt AA v/v.vv /AT AA VV / . VV 35 551.00 529. X- 507.00 461.X 614.X/m ftft ViliVV / t / AA Vi V* W Crtt AA Vi, i a VV Crtrt AA Vi. / . VV c rt aa Vi/.vv / AA Art vw. vv X 003.00 4X.X 535.00 596.XAf ft ftft rtv*. VV Ct rt AA Vi )* * w Crt a aa V4.-T# VV CrtA AA wv. vv Crtt AA v/ i.w Crtrt AA v/vvv TrtT AA / 4/ t W rtrt 541.x 471.00 577.00mil a 'rt AA rtv^ivv C1 / AA V1V.VV Ca / aa Vrtv. sAJ l Art AA OW 1 w Crtrt AA w/. vv / Art Art wv* VV -rrt / AA Crtrt AA /4V.VV V7/.vv 463.X 540.00 612.00 507.00rtrt Crt* AA Crt* AA / Art AA Crt/ AA W V44VV w*i w UVV> VV wu. VV Crt / AA v/v.VV /At AA VW. VV ervrt aa v/v.vv 39 Crtrt AA w>7^a VV 6C5.X 590.00 506.X 531.X Crtrt AA V/V. W 575.00 607.00 530.00 579.X /TT AA V//VV 40 571.00 CAA AA wTV. W 577.00 crt a ftft v/t.w 575.X 531.00 err aa W/ a VV 024.00 532.00 6X.X / Art AA WV* W 41 603.00 523.CO 577.X 571.X 579.x CAC AA J?v.vv 539.00 557.00 521.00 X2.X v/ vAAv.vAvA 42 570.00 504.X /Crt Art vOu. w 5SS.X 594.x vCr/tr/t*vava / t t AA uiiiW 543.00 591.00 536.X T/ itO/ tAvAv 43 553,00 14Cf AA rtv/ VV Crtrt aa V4?*VV 605.00 553.x cVartr/t.vava CCA AA wv. vv 554,00 531.00 / WirtArt AA W / Trt AA V/ /.W 44 530.00 512.X 62Q.X 536.X 605.X 540.00 500.00 575.00 703.00 663.X Z Trt AA V/ V. VV 45 016.00 539.X 551.X 529.00 Crtrt Art V4*.VV 613.00 671.00 571.00 nJ/rV,. W*A CrtC rtrt V/v.VV Crtrt AA v>/.w 40 520.00 Crt/ Art WOV. VV 532.X 553. X 533.X aca m VvVrtrt. 550.00 093.00 553.00 663.X 703.00 n 'J' <M oo o Co TA-/* CwOvA# AwA cvoiVc*vaVa v/ wO1A/ t VAVA COT Vi,/ 1 V*AV Cu`Ofc-l WA V/ -/ff*\4 v`.VAi cVaTnV. vava CvO/T/*vava Cv/TVA t VAAV Vi AfAV * Va \A' W i.* vAAv ta\hj 515.CO Wf AVA. 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AWA CVO7V/ *AVVA cWni * vava CwOi4 1 vAvA V/ O^VO* AWA O/ 4iuO.VAVA VinT/aVaV V/ TAVC* AVVn V(MTMT. WAA CvO/ O*. wAA O/ OO 664.X CJi4VA* wAA 620*00 660.00 Wi 04i. AvvA w/ OvA* AvvA CW/VA AvvA CWOVC* AWA CvOvA/AvOv CV/TV/ , AvvA W/ OVO* AvAv 67 626.CC CWCVO# AVAV v/ T/Awavva XI. 00 w(vP# Avvfl X7.0C 510.00 nWOVA* AWA T4AWA AA VV V/ AVOV#AvAv CvCwO. AwA 70 6C7.X 604,00 610.00 619.X 6^34, X W/CTi* WAA w/ OvC. WAA W10V/ * WAO V< T0 0V*VAVA CWA/Ta AWA CtVOOil AvvA 71 634.X 566.X CwOO/# wAA C4A AA ViVa VV C^vAOu. AvvA VCi4WAtVAVA cVo/<ofc. avav V/ 4iTJ* OWO v/ AvCv.vAvA CWAVO* AVAV 757.X T/iO. 607.00 4G3.X 496.00 601. X 610.00 626.X 624.00 554.X 557.00 T/ O4.MT* AWA V/ O7OU. AWA T/ OV 476.X XI. 00 601.CO 549.X 552.00 5i3.CC O/ CWO* VAOV 6C9.X 633.X W/OT/ a VAVA T/CVJT* AVAV 74 606.X 501.CO 570.X CVT/4O.VAVA 569.X W/OVA* AVAV 664.00 672.X V/ 4iT4* vAvA T/ *4T/ a VAVA 6X.X 75 551.X 676. X 609.00 cA/l0ilVaVa 622.X iCCaCO 507.00 6X.X 677.X / /T VV/ a WAA Wl Cil# AWA 76 577.X 620.X 567.X 620.X 590.X SCO* CO 611.00 V/ AvTl OWO 655*CO 67C.X T/4iVO*VoVA 77 576.X 606.00 609.X 612.00 CVAAAV.AVAV ws.co CwO/T AvAv cVo/Vca AwO 602.00 W(IKTa OVVA O/O/O//OWAA T/ OV 6X.X c<n /w WV. VV 514.X CvT/O/.vAvA V/ 4OVO AWA cVoWo* AvOv OIMlAi*vAvA w1 O/T * waa / AC AA O^OO AA OOOO AA VVVa VV 7/7/*VV ////#W TO // 605.X nA (O.W 579.X CV4iT/ a AVAV CTO AO ijt /* W cVo/Vo* avva CwOvA. AVAV W/ / ^O* OVVA CVO^JTI* 0V0V OOOO AA ////* VV O/O/O/O/ aVaV 30 546.X 59C.X 551.X WCCT4 . AWA WC/ 4i WAA V1 4i4iiWAA vCOwO. vAvA WCO/T# VAOV V/ Va4aIvavo O/ O/ O/ O>wA n n//o/o/n.vava 04 Vi ecn /v. 53G.X 55C.X CVCW/# vAvA CvvOvO AwA 570.00 / ma aa Otv* vv V/, 4i 44 VAVA cW/ 4i OVVA O7 O/ O/ O/ AvOv OOOO //// # AwO 00 Vi wOO 54G.X CA * AA y<TlUV 697.X 557.X J&ImVV 5C3.X 560.X 629.X CVT/ 44 a AWA 517.00 505.00 517.CC CvO>T/vAvA 517.00 CWCVO* AvvA CIO AA Vi^.VV 657.X 0000 AA / ///aW O/ O//O/A1AvvA 51C.X O/O/O/O/AVOV O/O/O//OAvvA 04 ITTT AA V/ / . W 549.X 562.X CJ"lVA* AvvA cwouoi vAvA 642.00 T/l/vCv. AVVA O/O/O/ O/ * WAA 7797.X 9777.CC O/ O//O/O* AvvA oc W 610.X 501.X 501. X 507. X Vt. 4tiTiVAVA CvOwO1 AvvA /At*/!>/AO*AwA O/ O Ot O/ a WAA 9797.X O/O//O/OVAVA O/ O/ O/ O/ * wAA AV#v 504.X CVMTCV.VAVA 622.X CV4lVAa AWA 521.X 519.X 9999.X O/O/ O//OVAVA 070/0//0* 0vv0 O/O/O'O/ OVVA 0/0//070 1aVaV OT V/ 502.X 477.X 9999.X 9999.X 9979.00 O^OyO/O/*vAvO O//O/O/.OVAVA 9999.CO O/7O/O7O AvvA O//O/O/OvAvO O/ O/ O7 O/ * AWA sc 9797.X 494.X 9999.X 9999. X 9999.X O/ O/ O/O/ AwA O/ O/O//O*vAvA 9^?.X 9999.X O/O/O/O7 Won O/ O/O7O/ AA VV 07 9799.X 499.X 9999.X 9999.X 9999.X 7999.X 9999.CO ICC 7979.X 9999.00 OX O>O/O/.AVAV 70 9999.X 562.X 9999.X 9999.X 9999.00 9999.X 9999.X .X 9999.x 9999.CC O//O7OO7AVVA 71 9999.X 619.X 9999.X 9999.X 9999.X 9999.X 9999.CO ` '.CC 9999.CC 9999.X 0/0//00/ avva 72 9999.X 9999.X 9999.X 9999.X 9999.X 9999.X 9999.X 9979.X 9999.X 0//0/0>0avov OfOtO/OtAvvA rtflNS STANDARD DT.'IATIGNS N= 556.47 54.63 552.79 51.54 557.76 49.7C 553.50 50.94 CCO 04 W7.V4 cc 00 w* w C/C 0/ wv. w /O 4T w* 1 / CTO 4 0 v/^*if / A OO W* Ov coo CT WV* V/ /T M Vi. Vi. co/ 0/ wv* w 66.45 /OC 04 Vi-V. Vi T4 O/ / 1 /V /OO 1* w/* /T / O AM V/ iT G7 91 36 36 nt w w on VT 00 w X TT // ~T( 1V 1-12 nAnuumUiaiti ri'nAo0*L7 nwo ionniTiiitfTiftriivo *inJii* toiv JUST ABOVE tJEXT PERFORATION RETURN ::s SL 082412 1-13 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Individual Body Weight Data for Male Rats noi'p Tlinj |T fVATA int ui vni fvWi ; // / " vwiv ruiittnL U\ "I nniwn wwuiv pata ivim ta rvAi nnrp paai* ai i AAt nn, At9A*A iv UAvywt_v mvwh nuu vnuvvwni ivtv ruA< it irL T>Aw UP t 436 PAv bn > two PAW vn\ 7/ / paw un 1 w^t paw LTJ 1 VJi paw un t -Jl w P Av yn 1 / 1n Ui4 nAW L*n 1 / A1 vtv PAW yn 1 Vi t n*w un tAd / Vt /4 l(A An / / A AA l AA AA 667.00 604*00 494.00i ww/ vv Ovv* VV V/ViWV 1C AA v/v*w 7 Ai AA UVTi vv / *A A A Wt/, w CA / AA Ww* VV n tAt aa t4 4 AA TA1 AA 694.00 519.00 433.CO/ v/ w /it*W /iViVV / Aj aa V*t*VV / / t AA WWW* vv CJA AA %tV* Vv CCA AA wwv* W 690.00 711.00 453.CC 556.00n / cn AA w VWt*vv / tA AA VI Vt Vv etc AA WWW* VV *AA Aa tivaVV Ann aa t//*Vv CCC AA www* vV A / AA AA CA/ AA 605.00 450.CO 566.00t WVA* vv wvO*VV /A/ AA vvwVv RtA AA W/ Wi VV CAP AA VW* VV cm aa W i i. vv Ann aa T/4iVV C W 604.00 530.00 Cl f AA wuw vv 439.00 5il.CC CtA AA w/ wvv M A AA Wit* VV 631.00 1 1 A aa VitiW tA 4 AA iviVv 1 O ccn AA jJVtVV 599.00 651.00 556.00 533.00 534.00 642.00 l*C AA W1V* W 560.00 623.CO t I Cty\ AA VW/iW 657.00 657.00 643.00 772.00 640.00 ACA AA W^ VV 556.00 inn aa t/A., vv 400*CO n v 675.00 479.00 693.00 623.00 64C.CC 1C33.C0 611.00 561.00 CAA AA Vv4 W CCA AA WW*iVV 9 630.00 603.00 tAA AA /vvvv 536.00 621.00 /AC AA WWW*VV 607.00 CA* AA w/t*vv l A* AA vvivv 527.CC 10 637.00 / tA AA V/ VtVV 583.00 767.00 Ctt AA Wi./ vv dAA AA t/v*vv 604*00 C*A AA wtv. w 916.00 591.00 11 676.00 545.00 700.00 620.00 AA AA 1Wi VV 619.00 650.00 ICA AA wvt*Vv enn aa Www* w / AA AA WWV* VV 12 490.00 760.00 702.00 639.00 /tPA AA voivv 591.00 566*00 393.00 /,an aa %.*t vv CD! AA wtw* VV 10 d AA AA t/t* w 541.00 607.00 691.00 599.CC CA AA W/t* VV tAA AA I VV* vv 571.00 CCA aa WWVi vv CA* AA WV/ W T / < *1 A ! i AA AA AA 646.00 615.00 571.00it /Ui*VV W/W*VV 1*1 Aa Vi 4VV A AA V4V vv an aa tv/*w cm AA V/Vivv ATt AA /t!mVV 545.00 4C e*>c AA tAt AA caa AA iW V<^*I w / V/ *VV JWiVV CAA AA V/ViVV CCI AA VW* VV / At AA w/ w cn aa %V7* W ac aa www* vv /At AA ww/ * W 4 / / AA AA 'n aa 713.00 621.00 597.00 Vv 9999.00IW wv^f w ut/ , w CT< AA VWi VV CtA AA V/ i-m cm aa w7t* W 1 An aa wt/vv 17 723.00 625.00 666.00 inn aa WW* VV 629.00 650*00 662.00 CAi AA wt, vv Cifa aa wtw, Vv 9999.00 10 600.00 559.00 624.00 cn* aa WltW 571.00 604.00 637.00 674.00 672.00 IWVV AA /t)/vv 19 623.00 630.00 666.00 545.00 593.00 591.00 CAA AA wwv>vv 725.00 / A4 AA AA<V% AA WViVV ////VV 20 567.00 591.00 5S4.00 624.00 574.00 CCA AA www* vv Ctt AA VII w 533.00 523.00 9999.00 21 602.00 633.00 631.00 641.00 614.00 664*00 tCA AA /ww*vv 537.00 Ain AA t/i*vv 9999.00 22 504.00 546.00 696.00 644.00 600.CO 657.00 619.00 699.00 712.00 9999.00 AA yw 620.00 650.00 779.00 655.00 605.00 eivt AA wuw* vv 656.CC 561.00 350.00 9999.00 24 599.00 673.00 647.00 736.00 tAA AA 1v#vv 745.00 699.00 enn aa www*vv 599.00 9999.00 25 570.00 460.00 707.00 543.00 / /O AA w/* VV 624.00 525.00 545.00 9999.00 9999.00 aw 675.00 694.00 632.00 655.00 606.00 647,00 563.00 607.00 19999.00 9999.00 At U 636.00 744.00 703.00 665.00 637. CC 1 * A AA cut* vv 649.00 573.00 AAAA AA /?/>.VV 9999.00 nr, aw 647.00 626,00 561.00 735.00 761.00 657.00 Cl 1 AA WWitW 593.CC 9999.00 9999.00 29 771.00 661.00 636.00 655.00 662.00 633.00 593.00 735.00 19999.00 9999.00 00 634.00 542.00 311.00 692.00 613.00 676.00 633.00 533.00 19999.00 9999.00 31 607.00 654.00 720.00 653.00 661.00 479.CO 615.00 625.00 9999.00 9799.00 32 656.00 653.00 632.00 705.00 633.00 547.00 727.00 497.00 19999.00 9999.00 33 661.00 776.00 731.00 701.00 642.00 651.00 620.00 TVOOO AA ///tVV .9999.00 9999.00 34 533.00 671.00 710.00 667.00 365.00 641.00 557,00 9999.00 '9999.00 9999.00 35 660.00 677.00- 741.00 547.00 525.00 597.00 623.00 9999.00 '9999.00 9999.00 36 766.00 722.00 603.00 692.00 633.00 637.00 530.00 9999.00 19999.00 9999.00 37 597.00 719.00 706.00 596.00 535.00 643.00 ini aa TW* vv 9999.00 '9999.00 9999.00 *yi w 630.00 tAA AA /vv.vv 579.00 561.00 CAA AA V/A* VW 520.00 9999.C0 9999.00 '9999.00 9999.00 aa w/ 676.CC 606.00 393.00 396.00 641.00 723.00 9999.00 9999.00 '9999.00 9999.00 40 717.00 661.00 639.00 564.00 633.00 465.00 9999.00 9999.00 19999.00 9999.00 41 715.00 613.00 694.00 692.00 653.00 657.00 9999.00 9999.00 !9999.00 9999.00 42 727.00 564.00 574.00 695.00 603.00 565.00 9999.00 9999.00 '9999.00 9999.00 40 643.00 444.00 703.00 634.00 CAA AA JU| Vv 524.00 9999.00 9999.00 19999.00 AAAA AA ?///vv CM tt 603.00 567.00 716.00 710.00 728.00 657.00 9999.00 9999.00 '9999.00 9999.00 45 573.00 691.00 646.00 633.00 4CC.C0 639.00 9999.00 9999.00 19999.00 9999.00 46 4S6.0C 446.00 636.00 626.CO 690.00 446*00 9999.00 9999.00 19999.00 9999.00 SL 082413 4T Ty / at aa vi./ w AAAA AA //// VV 4A TV .A T/ P/A rtrt VV4,. vV /.AA A a v/v* w 4pVaT,VAAv "T^ a AA / oi vv a/ A/a/ a/ AvAv 50 500.00 IftC AA T*V.VV 015.00 7907.00 51 750.00y aa a a Wv vv VTV. VV ffrt/ AA W/ViW 52 T/AvA/.vAvA 641. CC ffAA AA WV. W 654.00PA vO p/ A AA Wv. VV //7/il/V ) /// AWl Art ////iUV At>rttr /// ' p VT / AA AA w/.w 574.00 071.00 PP w1 p/ w ( *A AA VTv. W y Aa aa wv. W /nc AA VW, VV cno aa VV-' * VV PT V/ vV/ AA /, Av\Ay fA/ t VV 024.00 070.00PA W PAP Aa vvv, w 752.00 vy.vvPA TAT AA / PT AA / / A AA V/ / Vv> I i W W/ VV aaaa aa / / ,' y i vv aaaa / ? >/ . / /1 f * AAi7A AAAA AA '///, VV \eo aaaa aa AAAA AA / / / / vv y y/y.VV AAAA AA y ,M / i vv ya w 477.00 Ml AA V44.VV 606.00 y < PAT AA 005.00 W'i W / . w t A y 4 j* aa Vi. VTT.VV "VAA AA / //VV 9999.CO /aa/a/a/,avva / A TP. Art W*s/ 1 ViVv / T4 AA V/T.VV AAAA AA / / / /. vv 9999.00 VT y. AA AA Oi^ia VV VW.VV 9999.00 9999,00 9999.00 AAAA AA / / / / . VV 9999.00 /P W /. A ( AA VA.V* VV 60/.CO 9999.00 9999.00 AAAA AA /7//.VV 9999.00 yy W 650.00 655.00 9999.00 9999.00 y t TA/ AA / AA AA 9999.00V/ / VV, W 044- VV AAAA Art / / / / VV A/ A/7AA7,AUAv 9999.00 AAAA AA //7/.W 7 >'t f * vv a'/ a/ a/a/ avav 9999.00 AAAA AA AAAA AA ////* VV / ' ' / W Oo vvTA 4 AA y i.i 651.00 9999.00 9999.00 9999.00 9999.00 9999.00 AAAA AA AAAA AA /> / 7 VV / / / > W ya V/ 605.00 99^,00 AAAA AA / '/? t VV AAAA AA /// /W 9999.CO 9999.00 AAAA AA >/// VV 9999.00 A/ A7 A/ A/ * AWA AAAA AA ////aVV 7977.CO70 676.X 0999.00 9999.00 A/ A/ A/ A/ AWA AAAA AA / / / / ,UV AAAA AA / / / / VV 9999.00 9999.00 7777.00 T4 y4 666.X 9999.00 9999.00 9999.00 9999.00 9999.00 9999.00 9999.00 7777.00 TA / i. / AA AA VW. VV 9999.00 9999.00 9999.00 7999.00 9999.00 7999.00 AAAA AA / > / 7 *VV y aa At WV.TO TA AA /V. /V i / PA 4 4 i W/ Ti I, /A AA J Q/.VV / A/ 4 A VW. 4 V TA AA / Vv if AA AT VV/* V/ A. AA 71, W / at ta vv//v T/ AP / V, w 577.50 A/ AA w, W PTd A/ g/7i?w IX. 12 PAT TT W/ * ^y . Al AC IVT*/V 61TA 55 yA AT AA 24 15 / i. TV V/ Vi, 1-14 4 1 / CA AA W/.VV 655.00 v/V. w 67.X Pny aa v/v,vv IO Art vi/ivv A i. 677.X 66S.CC w/ A/A.vAvA .e aa T*/ 6 vv W? AA 4 AA A A TW, VV A V /AA AA V.4V, VV 610.00 476.00 aw. VV / at Aa VO/ , W A t A AA TX^T, VV 4 WP/ vAi vAvA 555.00 434.00 463.X 655.X VW, vv TAT AA y V/ , Vv P V 646.X 745.00 611.00 636.X VTV.VV CTA AA v/ v< vv 4C9.00 PAA AA VVW*vv 642.00 567.00 60 PAT AA V/ / . W BP/ AA Wi. VV ap aa CA< AA i,V. W jyn vv T / /0T/Pv, AwA 646.00 577.00 / AA AA WA. VV 625.X Ml AA Vi i w PA4 AA J74.VV C# AA vVi VV 655.X CS.CC 514.00n V 6 / A A AA VAA. VV / AA AA WV, VV TAA AA /IViVV Vw, w ty r4tAjivAvA PWC*i. AwA 4 AA AA TW. VV Mrt AA AlVtW 9 635.X 577.00 644.00 645.00 / AA VV/.VV / *P AA grv,vv T.A AA y 4/ , VV Cm / * VV 10 605.X 631.00 637.X 743. X (TA AA V/4. VV PTA AA v/ v* w 14 14 643. X 634.00 640.00 646.X -TC A AA /VT.VV 62C.X vvi. w PTA AA V/ V, VV CAA AA VW , VV PAA AA Vi.4.. VV 620.X 627.00 663.00 612 7AT AA /V/ . VV AA rtA 4V VV C/A AA w/.vv C"7A AA V/ i. VV JvviW TTV.VV PAT AA V/'.VV 4A IV T*A AA / TV. W 70S. 00 650.X 652.X 000.00 / AA AA Vi,/ vv C AA AA V/W. VV 429.00 PVT/VA .VAvA 14 652.X 642.00 654.X tWmi. nvVn 664.X v/ AvPv.vAvA / aa AA ViU* VV A> AyA/A/,AVVA 15 637.X 657.CO 640.00 y/ t*ya waa 575.X CAa AA V/itVV PPP AA wv* w 16 640.X 632.00 6C4.X 477.00 433. X 009.00 w/ AvAi AvvA 17 7X.X 570.00 476.X 4X.X 6X.CC 015.00 / A4 AA Oil. W 00 9999.00 00 9999.00 4A IV 605.X 31G.0C- 617.X / AA Art WV. VV 552.X 5CS,C0 C/T AA W/ VV PA 4 A A Wi.VV AA AAAA AA W /M/iW 19 653.X 602.00 /AA AA VV/ VV 572.X X 347.X pjn/t. . v/.Av pen aa W/ vv V4.V. VV 000.00 vi awa. avva ,> wtaa aa /V . 031.00 AA OAAA aa vv ?/// vv v*w 00 9999,00 A14 577.X / 1 rt AA ul v. vv / AT AA LhJi vv PViAv. AvAv /AA Art AAAA AA VWiVV / / / ' , w AA 6C4.X 551.00 AAA AA / / / VV TJT/ 4i AWA 467.00 7777.X i w,n i AA / ///,VV 622.XAA CAP AA CftA AA A-V V/^. W V/V.vv v/A/vP .WAA A//A/A/,AVAVA aaaa aa ////vv AJ 601. X 622.00 /A. AA VV..VV WV. VV 6X.C0 wVVT. 4AA aa aaaa aa AA W/.W ///?,VV //>/,VV X 005.00 661.00 633.00 IA4 AA T/T.VV 597.00 XO.X 9977.X A/ A/ A7A/ AWA A/ 617.X TM AA /i/.VV 677.X TV6/7.X 553.00 PA 4 AA WT,VV 594.00 Vv V/JA4 Art ywV> AA AAAA A r TVT. // >VV //// V 27 716.X 631.00 673. X 4!1?2.X 603. X 000*00 711.00 AAAA AA //>/.VV //.>/* VV AA 634.X 651.00 641.X 530.X 535.X 742.00 005.00 7777.00 7777.X a?a/ a/ a/ waa 27 636.X 672.00 567.X 702.X 7X.C0 599.00 7777.00 7777.00 SL 0824 AA w 01 AA Wi> AA w 04 ac W A/ W AT V/ AA W Wt V> 40 / TA AA V/ViVV / /. 1 AA Wi t W / A/ AA WVl vv J AT AA w/ vv / AC AA Ui^iVv C/A AA JWiW / AA AA W^i vv / AA AA Wv* W / / T AA vw> vv / / a AA Wi,vv f AT *A W Vv / Tf AA V/ VI vv /A/ AA VWi vv c/n Art W4,f W / Ail AA WT* VV /AA AA uvwi w / dl AA VT4 W 675.X / TI AA O/ liw CAA AA Wi. vv / / d AA VO*T VV J A4 AA v/n vv CTd rt A V / T# vV t AA AA V4i. VV ! Crt AA w VV /TA AA V/ViVV / AA AA wv* w { A AA VTi.vv CAA AA Wi vv T| A AA /iVvv CTd AA V/ T| vv Cf t aa VUWivv 602.CC / / A rtA wv vV Cl A AA viz# vv t AA AA Wi.WiVV /Ad AA VVTiW e/A AA WTiW TAA AA /d./iW C/A AA WV vv CIA AA VTV*VV CAA AA W-JiVV CAA AA VVViVV CA4 AA VVi*VV CTA AA V/ VV CAA Art! w/ * vv CIA AA VTV * w /AC AA VtViW CdT AA VT/iVV *CA AA TW/VV //y> AA Ov / VV TdA AA / T4 VV CA/ AA u'/VlVV /A AA V/1 vv A/A AA WOlVV / AA AA wwi vv Irtl AA AAAA AA /WW4 AA AAAA AA T/T,VV vv < y /, w > ! J ' *VV A* A A A VITiVV Cl A AA AAAA Art rtrtrtl AA AAAA AA ViVa VV r / / / VV / / y;. vv/ 7*77%VV / AA A A uw* vv nrt AA AAAA Art JTA/Vrt AA AAAA AA T / < * w ? / / 7 VV y 7 7 W />/ivv CIA AA VTV,VV CdA AA VTV,VV AAA AA VTV* VV TAA AA AAAA AA AAAA /`A AAAA \A / W* VV / / > / VV ///'VV /y y t \ vv / AT AA VV/ivv 9X7 AA VV rtrtrtrt AA ////*VV AAAA Art / / I VV /A/ AA VVViVV AAAA //// X AAAA AA //7/VV aaaa aa 7777iVV AAd AA V/TtVV CCtA< Aa AAAA Wi vy 2 / ' ^ oaaa aa AAAA A A /7 //* vv y//"*vv TTA AA AAAA AA rtrtrt^ AA AAAA AA AAAA AA //ilVV / ///* VV W ////.W / /y/vv / A * AA AAAA AA AAAA AA AAAA Art AAAA AA VVT, W /' / * / VV VV // ' ' VV * / '/VV / 4 A AA AAiAA AA AAAA AA AAAA V1Vivv '//.' W / / ' ' VV AAAA AA 7/y y * vv / * A AA VT * VV 9X9. CC AAAA //// CO AAAA AA / / > / ^,'V AAAA A.N 77/*%VV 41 T< A AA /i/vv dr/ aa V/v* vv eni aa VOT* VV /AA AA Vi.v*w / * AA Vtt*vV e * < aa AAAA AA AAAA A A AAAA AA AAAA AA VTi W / / t J x\fK> / 7 > / VV j// vv ' >y/vv dA Ti. ffTA AA V/ViVV C/ A AA wv, vv v/ AiWAy ivAv/' / 1 A AA Vii.aVV C/ A AA WV/W AAAA AA /'//VV 9999.X A^AA 00 AAAA AA ////VV A/?AA.'A/ AA VV 40 C-7' AA V/V*VV Crtrt AA WV* Vv CTA AA V/VtVV cr* WT AA VV CdA AA VTV VV A/ A//AA<lAWA A/AtA/A/iAVAV AAAA t t * t' AA VV A/A/A/ A AA VV A/A7A/AyivrtvA M TT TA< AA /Vii w O/,AvIi* AA vv ( AA vj./ AA vV erA AA WVaW A|A AA vl^iVV A/A/A/A/lVAVrt A/>AA/ A AA VV AAAA ///> CO A/A/A/A7 AA VV AAAA AA 77/7%VV AC TV C/ A AA WV vv CTA AA V/ v* w 1 AC AA V4V*VV /TA Art CCA AA rtrtrtrt A A AAAA AA AAAt*l AA AAAA rtrt AAAA AA u/4vv v-j^Vv / ///ivv ////vv / ? / f VV //7/.VV / / / / W d tv <l"f T/ dA TV C/V AA v/t# w CAA AA v/v, w / a AA Uii VV / 1 A AA ViVivV / IIA AA VTV* VV /1 / Aa ViV* w CCA AA VV/t VV Mrt AA Vis/* VV CCA AA vv/ vv CAA AA V7/|W TCA Art /VV.VV /TA A A 0//ivv TAA Art rtrtrtrt AA AAAA *A AAAA AA AAAA A> AAAA AA / Wi VV ///.' w /// vv / / / / VV ////VV 7/77%VV /A/ Art CvViW AAAA Art /?/f tVv 9999.00 AAAA //// AA VV 7X9. X aaaa AA 7 77/w /Cl AA Wiw 9777.00 9999.00 AAAA >tn AA W 9X9, X AAAA AA 7/77%W dA 1/ 50 C7A AA v/ /. w MA AA viv* W Cf T AA w/ * W / AA AA VJ.V* S/V CTA AA V/ V* VV / CA AA Wv* VV /CA AA VW*W a;A AA 4VV* Vv /T* AA V/ivV CAA AA Vv^tW AAAA AA /7/ vv 9797.X AAAA rtrt > >/ / t VV AAAA AA /i/ * VV AAAA / /y/ rtrtrtrt /t f / AA VV AA vv rtrtrtrt AA y> / / w AAAA Art ////W AAAA AA ////VV AAAA AA / // /VV 51 / Art AA WV| vv /W M ViJ*VV TCA AA /Vv* vv 437.X 9977.X AAAA AA //>/*W 9999.X 97X 00 AAAA AA //?/*W XX, 00 CA v4 500.00 / (IT AA OT/ * W CTA aa V/ Vt W 406.00 9999.X 7977.X 99X.X XX AA VV AAAA rt A ////VV XX. CC 50 604.00 572.X 665.00 CAA AA rrfvyri AA 9777.X AAAA AA AAAA AA 9X9.00 AAAA AA vV/aW //Z/lVV //?/*W / / / / W / >/ y*w 54 613.00 TAA AA / V4* W 576.00 442.X 9997.00 9997.00 9997.00 77X AA W 29X.X 9X9.00 rc W c/ w 647.00 657.X 553.00 CCA AA MWiVV 665.X CAA AA V4WtVV 777.X 7777. CC 7779.00 7997.00 9X7 X 2X2.00 AAAA AA 7/77%VV 541.X 9777.X 9977.X 7777.X 97X X 99X.X 99X.00 57 604.X / / A AA uO/. w AAl Art Wi vv 642.X 7777.00 9777.00 AAAA AA ////IVV AAAIJ X AAAA AA / / / VV 99X.CC CA W CA/ AA V'V* VV 622.X 444.X 634.X 7977.X 7777.00 XX. 00 X97 X 99X.00 9X9. CC 5? 500. X / Jrt AA VT/*W 514.X 725. CC 9977.X aAAa aa ?///ivv 97X.X AAAA ?/// 00 AAAA AA ///7iVV AAAA AA 7777tVV X 725.X AJA AA VT4* VV 562.X 557.00 7777.X 9797.00 97X.X 97X AA W AAAA aA y>/>,w AAAA AA 77/7%w V* 567.X CAl aa VJ.ii VV 771.X 9797.X 9777.X AAAA AA ////iVV 97X.CC AAAA /*/> AA W 2X9.00 AAAA AA 77/7%VV /A Ui. 656.X AdA AA VTV* VV 77C.X 7779.X 9999.00 AAAA AA 2// * VV 97X.X AAAA f /1 f 00 99X.C0 AAAA Art /7//* VV to 646.X 511.00 7777.X 7779. CC 9X2.00C/A AA WO* W 00rtWAA AA AAAA AA AAAA / 2/*W /// tW tt AAAA AA 7///vv t4 561.X 737. X < Ad AA VVT. VV 7777.X 9X9.00 7799.X 9X7.00 X 99X.0C 99X.CC ts 402.X 621.X 694.X 9999.X 9999.00 9999.00 X97.C0 AAAA //7 > AA w XX. X 9999,00 tt 654.X 635. X 741.X 9779.X 9999.X 9999.00 97X.C0 AAAA / > >/ AwA AAAA AA />/ iVv AAAA AA 7/77%w 07 OX.X 575* 00 575.X 7999.X 9999.X 9999.X AAAA AA AAAA // '/ X AAAA Art /777xVV <rt*JAA QA tc CAA AA VAV* w 7C7.X 9977.X 7777.X 7777.X 9999.X 99X.X AAAA /JtJ X AAOA aa yy / 7W aaaa aa // / / w 67 471.00 645.X 7977.X 9777.X 9777.X 9999.X AAAA AA ////VV AAAA //// X 2X9.00 AAAA AA //"vv 777.X 750.X 9999.X 9999.X 9999.X 00TA rtrtrtO AA AAAA AA AAAA rtrtrtrt A A AAAri AA /V /2/ ,vv / > / W f f * f /t7 7VV 7'7 7 %VV TI / 634.X 573.X 9777.X 7777.X 2777.X 9999.CC AAAA AA /// *W 97X AA vV AAAA AA ?/7 VV AAAA AA > t t f W TA /4 6C2.X 7777.X 9997.X 7797.X 9977.X 9999.00 97X.X AAAA 7> / / AA VV AAAO y/> wAA AAAA AA 7//7iVV TA /V 663.X 7777.X 7779.X 9999.X 9999.X 9999.X AAAA AA >//yVV AAAA f > t> CC AAAA AA .> / / 7 vv AAAA AA 7777%VV Td /T 6X.X 9999.X 7777.X 9977.X 7777.00 9999.X 77X.CC AAAA 00 X29.C0 AAAA AA 77/7%VV 75 711.X 9999.00 9979.X 7979.X 7777.00 AAAA AA /// lW 77X.00 AAAA 7/f/ wAa 99X.00 99X.C0 76 762.X 9997.X 9777.X 7779.X 7799.X 9999.CC 97X.CC AAAA t/>/ X AAAA ,AA 7 y y/vv AAAA rtA y///vv 77 740.X 7777.X 9777.00 7777.X 9997.00 9999.00 AAAA AA />/VV 9997 00 9X2.00 9X9.00 HEANS CTANMRD vLv ini iviw fl= 623.26 77.10 610.00 614.74 535. X CVA/V/ *VATd 575.X CvOAAi.i ii |i CW/ A/ AVdT CWCTd , V/CV CVdTA/V,'A* 31.16 X.75 76.35 071iiv^/ IX. 6? T/ CVi AW/ AW/ iOAli AVdT* TdVA AWA* v/ 7A X 71 67 X Cvvrt 41 AVV/ i.V 20 IA iV 1-15 T/ CVi WAAVA 1 652.X V/ A4VA*VAVA 710.X 531.00 CVTfAV* AWA 551.X CV/TlI i AWA 549.X 513.X 470.X A U 701.X 722.X 615.X 664.X 612.X 572.X CVAi,T/ * AVAV X7.X X2.X CWA7A AVAV A V T/ IIVA lWA* 660.X 661.00 67SiOC CWATd , AWA 572.X 574.X 401,00 4X.X Td*iVCf rVtVrt 1 T 61C.X 655.X 644.X 667.X 537.X 576.X 524.X CVAiV/ ,VAVA 5X.X AVT/ CVi wAA 5 669.X 625.X 607.X X7.C0 551.X vC/TvAiVAVA 564.X VAA4AVlVAVA 457.X 430.X 6 653.X 595.X 627.00 624.X 5X.X AvT/ Ay* wAA 064.X TdiieV*VAVA 556.X CVAiiI*WAA T/ 633.X O/ Ai.AVi VAVA 0/T/A4*VAVA v(A/v/* wAA 550.X 551.X 558.X CWA/T VAVA 457.X CWC4A VAVA SL 082415 A / AA AA / AT AA CAT AA 1 ft-* ftA CT * "iA CAA AA 4 AT fftft ftft C A ftft C 4 A V Wv?# VV V//VV W/ i VV VV 1 4 W V/ ** vv Ov".'* /V TV / 1 W OVOvv JTi.i W OTVi V'. A / t*c aa /4ViVV C4 4 AA VT4 W / 4T ftft VA/VV / AA ftjl OilUl VV AAC A A WV VV 4 T 1 AA T/i,vv 4 CA *A Tout W / AC ftA W vv CTT AA O/ / 4 VV C / * Aft OU^i 4A 1V / 40 AA Vl4i VV / ftft AA W/ VV / ftft AA WOa W Mft AA *TT^ w 4 4 T AA TA/1VV CTii AA 0/ >J V'V / Aft ft A UVT 1 W /A * A A VV* * vv CCC '.A OOO 4 V'V CA 4 ftft O / T , v. V <4 *4 / Aa AA V4V 4 VV / A 4 AA Ov1vv 4 4 4 AA Tfl VV 4 4 A AA T*VtVV CAA AA VW * VV y AC AA L'VViV'/ CAA AA O/O* vv C 4 ftA OO11vV AA 4 *t ft OO i 4 W ^ftC ftft / V J * VV 12 611.00 JCA AA 4AC AA CAA AA C/ T AA C / A AA / 4 A AA 417 .ftft / AC AA AAAA ftft TOO. W TVO VV wv* vv OO/VV OVVivv ViVVV flitVV VJ/ivv ft ft ft ft- * VV 494.004 A 44 0 AA C 4 A AA Cl A AA C 4 4 AA / AC AA CAft AA / A* ftA r A* AA OAAA ftft iO TA Oa W V4W* W w> * vv OTTi VV O'Vo* vv OUTvV W * * VV OV* 1 V'V /t? . VV 14 M AA AA If 4 4 AA / AC AA CAT Aft / TA AA T / * AA CTT ftft /1ft A A CAA AA OAAA ftA 14V.VV Vi 1VV WVi w O//VV O/ V* VV /vv* vv 0//1VV */ii V'V O/O1VV 516.004C / A J AA CAA AA AA4 AA CTT AA l AA AA C 4 4 AA CC 4 ftA / ` 4 ftA OAAA ftft iO VVT*VV V/^4 W O/iiVV O / /vV UViiW OTT1 VA* OO * VV vliivv ft ' < ' 4 w 410.004 / /TA AA C C AA CC4 AA / 1 T AA f 4 A ftft CAA ftA 1 AC AA AAAA ftft Oft*AA 4V V/ Vi VV WVi Vv WT, vv Vi/VV OiV*vv OV.' vv viVvv / * w / / / 1 '-.ft n / AA AA / / A AA CAA AA / A 4 A A CA 1 ftft 1 i T ftft / 4 AA 1 O / AA OAAA ftft OAAA ft;'1 / W/.vV WO VV 07 / a W V/T VV WV 4 Vv vi/t Vv ViiVV 0 w 1 VV ft/ ft VV 4 A ' AC AA / 4 A AA CA4 AA Mft AA / AA AA CAA A A CCA AA 4 AA Aft aAAO A OAAA ftft IV WO VV ViViVV V 7 T i w VI4I W vv/ VV OOi- * vv OV.VV fw * w / 7 / ' * V V / / 7 / V 4 A / AA AA ffftft AA / AA ftft CAA AA TCA AA 4 AC AA 4 Aft AA / A4 AA AAAA ftA OAAA ftft 4 / WjL. VV ow 1 vv W/ ? VV vvv* vv /J*iVV T/O.VV T'T * VV VV 4 * W , ' / V'.' ' 7 /w AA CAA AA i A 4 AA / AA AA / 4 4 AA / AC AA A 4 A AA CTO AA / ftft ftA AAAA AA OAAA ftft 4.V V/,4. W vvnw vvvvv VTTiVV OVVivv viiivv 0 / / * w w / W / ' '/*vv / " ' 1 w A4 / O / ftft TOC AA /.AA AA /AA AA /A/ AA ( A 4 AA CAA ftft ftfn'nft ftA AAAA ftA OAAA ftft ^4 V4V* W / VOt VV ViXi vV OVA 1 W OVO1VV 04i4VV WJ VV / //.vv ft / ,' / VV vft Aft CC4 AA VVT W C/ 4 AA OUT*VV /7ft AA O/ Vi VV / AT AA V4/ * VV AAC AA V/VVV / 4 T AA Vi/ # VV C * T AA AAAA Aft AAAA ftA AAAA ftft Oi / * W / / ' r W'V > ft//*VV / ft1 ' 4 V J AA *V TAC AA / IpV 1 VV / / / AA 000VV CO* AA WT1 VV T / T AA /0/vv CAA AA O/0a W C4T AA OT/VV 4ATi AA ftftftn AA aat*a aa OAAA ftft TWl VV '//*w / / / / V'V ////VV A A / AA AA / CA AA /Cft AA / 4 A AA C / / AA 1 CA AA / AA AA AAAA ftft AAAA Aft AAAA ftft it UV/iW WV vv WV vv Uliivv vOv ? V'V WV VV wv vv //J '* Vv ,ft / / VV // /*VV 605.00 9999.XAC / TA AA tfftt AA **C4 AA i.O *J / V* VV JOla VV /Via W AAT AA { A / AA / AA A A AAAA AA V / / l W Vvv * vv WA t VV /7//VV OAAA AA '> / / / t vv 604.00A/ Cftft aa iV v/v w /AA AA / / A AA CM 4 AA ff/A A A C / A AA AAAA Aft AAAA AA AAAA AA o^V* w wv* vv OTi 4 i/v OV'1vv 0O0 * V'V )J//VV ////VV 7 / ' / * V V 670.00AT TCA AA / 4 T AA 4 4C AA 4CA AA 4CA AA / 4T AA AAAA AA AAAA ftft OOOO AA i/ /v/a Vv OT/* VV TTV W TV/* W TW* W OT/* vv >///*vv ft ft ft / V"> ///* VV 665.XAA ttta ftft / TA AA W / oo* vv 0/ v* w / A 4 AA / AA AA CAA AA / 4 A AA AAAA aa AiWi AA OAAA ftft WVi 4 vv ovo*vv l/Oil W Ui/iW ////1vv ' / l V'V / "//* vv AA A/ 610.00 660.X 652.X PIT ftft vv/f vv 4 AA AA T^/* VV 502.X 657.X AAAA AA / <* .> 7 VV 9999.00 AAAO ftft / ft / ft # w OA / 4 A AA / 44 AA CAA AA Ct A AA CAA AA 4 CA AA / Aft AA AAAA AA aaaa Aft AAAA Aft VV VTV* W yiivv OOO a VV VW* VV V//lVV TOO* vv OOO1 w / / f / 1 W //// vv / / / / V V A4 IJf, AA / AA AA C4A AA / 4 4 AA / 4 4 AA MA AA / 4A Aft AAAA AA AAAA AA AAAA AA V4 v / v* vv ovoi vv VliiW ViT.VV OiTVV oiVi w OTV#vv //>,'* VV //7'* VV / ft//* vv 667.X 695.X 9X9.XAA TA4 AA / T/ AA 1 A/ AA CA* ftft AAAA ftft aaaa aa OAAA OA 04. / vr# vv V/ O* VV O^WiVV J/i*VV ''/// VV ////vv /'/'vv 609.00 729.XAA / AA AA CTC ftft CAA AA / 4 A AA AAAA AA AAAA JAQ aaaa aa AAAA A^ W Wil W V/ v* vV O/^iVV WiO*VV ////VV /,'//* V'/ 630.XA* / AA AA w AA CAT AA CAA AA OT uov* vv / w W/ VV W^4 VV ftlft AA 0 / V1vv OAAA AA /// f* VV AAAA AA f// /tw AAAA AA . > / 'VV AAAA AA ///,' V*/ AC lAft AA / 4 A AA f AA AA AAA ftft 1 AA AA / AA AA AAAA AA AAAA AA AAAA AA AAAA Aft oo / v/.w ViiiW WO* VV W>7ii W 1/iUl W V4V* W ////iVV / -> ' / * W ft///* VV / / / 7 i V^.' 619.X 625.00A# / AA AA l AA AA /AC ftft 6 1ft ftft AAAA Aft AAAA AA AAAA ftA OAAA AA oO wo* w ow Vv WO* vv OTv* VV // '/#W 7///* VV ////* VV /7/jft4 W AT TiO AA I AA AA CAA AA f 4 A AA / 4 4 Aft / 4C AA AAAA AA AAAA aa a^ta aa aaaa aa V/ t TO* VV VV4iW Wi# VV VTV* V\* OTT*VV trio* w t ? t / t w / / / t W ////* vv ////* vv 667.X 9999.XAA l**A AA w WA.T* w /T# AA t 1 A AA CAT AA CTA AA nono aa 0/ O* VV WV* W OV/vv 0/ 0* vV t $ fi*vv ftAAA AA AAAA AA / ft / > 4 w / / //#VV 600.XAA CiV> AA / CA ftft /AC AA CAA AA / 4/. ftft AtV.A AO AAAA AA aaaa aa AAAO AA V/ jvui w \MViVV o/o* W o/v* VV OTViVV -///* VV ''//VV 7/// VV / ft /VV 40 / * t An CAA AA CC/ ftft CAA AA / AA AA / at AA (TAAa aa AAAA AA AAAA AA AAAA ftft\ Oil*, vv V/V>VV OWi vv J/7iW l/4V|VV VO/vv / / / / vv 7 ' ' # V'V >/// vv ft / ' ft 1 W 603.X 495.X 676*00 9999.CC4 4 I 4C AA /AA ftft / 44 Aft AAAA AA AAAA AA OftiVi A A T4 wTVtVV W^* VV OTi VV /// /* VV / / //*VV / / ft / * V',' 69C.X 616.X4A / AA AA /AA AA / / C AA /.CT AA AAAA AA AAAA AA AAAA ftA OOAO AA 14 WO a W O/ / a W wo* vv Oo / W / / / 7* W / / / / t w / / / / w .'/// VV 43 679.X 679.X 6X.X 9799.00A/ A iftA CAC AA / CT AA VW* w 0/0* W vo/vv AAAA AA aaaa aa AOAA ftft / ' / ' 1 w ////* vv //,' VV 44 591.X 702.00 591.X 741 AA /T/VV 641.00 9999.00 AAAA AA AAAA AA aaaa aa AAAA ftA /// / 1 VV .> 7 / ft VV / 1' / 4 VV / / ft ftVV 45 609.X 610.X 582.X 517.00 9999.CCCAA AA AOAA QQ wivtVV AAAA AA aaaa /a AOAA ftA , ' / / 4 Vv / .ft //* vv ft / / VV 46 701,00 699.X 535.X 9999.XCA4 AA V7 i 4 W / A/ AA AAOO AA OOO*VV ////#w AAAA AA AAAA AA OAAA AA / / / / W / / .ft / a W / ft/ ft Vv 47 714.00 713.X 592.X 661.X 644.X 9999.X 7999.00 AAAA AA / / / / * v'v aaaa aa / / / /# w AAAA AA ////4 VV 43 727.X CAA AA J/4iW 609.X 664.00 9999.CC 7999.00CT4 ftft AAAA AA O/ 1 VV //' * * vv AAAA AA AAAA AA 7/ft/t VV / / / / # w 49 593.X 612.00 754.X TAA ftft ! W* vV 9999.CC,:".oo AAAA AA ///tW AAAA AA AAAA AA AAAA AA ////* VV ///^VV ////w 50 599.X 77C.X 478.X 1 A / A/\ OiO.W . .00 9999.XAAAA AA ///.W AAAA AA AAAA AA AAAA AA ,>///* vv ////# VV > 7 ft *VV 51 790.X 552.X 732.X 690.00 9999.X' 'ft f\f\ AAAO AA WV# Vv ///vv AAAA AA ////.W C"V*0 AA 7 7/7* vV AAAA AA ////t VV 52 572.X 625.X 555.X 6^3*00 637.CO 9999.CC 9999.00 9999.00 AAAA AA 7/7/* VV 9999.X 53 621.X 542.X 536.X 631.00 702.00 9999.X AAAA AA 7/?/iW AAAA AA 7/>/* VV AAAA AA ////VV 9999.00 54 570.X 69C.X 675.00 5S9.X 9999.00 9999.X 9999.X 9999.X 9997.CC 9999.00 55 702.X 637.X 669.X 659.00 7999.X 9999.X 9999.CO 9999.X 9999.CC aaaa aa ////1vv 56 657.X 545. X 705.X 4AA ftft T>V W 9999.x AAAA AA ///f*w AAAA Aft //>/VV 9999.X AAAA AA 7/7/VV 9999.00 57 547.CO 655.CO 603.00 730.00 7999.CC 7997.0C 7779.CC 7777.00 C 717.CC 630.CC 722.00 7C1.CC 7999.CC 7779.00 7777.CC 7799.CC 59 705.00 T4 / AA. / AA / iV* W 6w. 757.00 9777.00 7979.00 7777.00 9999.00 7999.00 60 667.X / 4 C AA ViO* w 663,, VV 04 /7> ? . VV 7997.CC 7777.00 7799.00 Mrrftl"/.v'Av 61 TOT ftft / *w T4 / AA /iOiVv 651. 2.00 9997.00 7999.CO 7777.CC 9797.00 /O VA / OA AA WVt vv 654.X CA/ owi 00 -* / > /. vv /0 OO 654.00 662.X 665. ,00 9779.CC //Vi vvnArtft AA ////vv AAAA AA A/VW AA AAAA AA / ' / > VV 7 7 / / W 64 731#CC 661.X 494,.CC 9777.00 AA AAAA AA nAtrt AA AAAA AA AAAA AA AAAA AA 7?//iVV 7///tVV 7 / 7 / W 7 7 / / W ////iW .0065 665. SC COftft AA 07^* Vv 534. 9999.CO 7999.00 /^/ivAvA 7779.00 7797.00 9979.00 7797.00 66 /TO AA 0/V* W / Ml AA OTVi VV 704,.00 9799.CC 7999.00 r/v//wi Awft 7999.00 9999.00 7799.00 7777.00/ T O/ 59S.00 C/A AA OO/ a W TftftO AA / OO'.1 VV 9777.00AOAA AA 7/7 '.VV AAAA AA AAAA AA / ///VV ///vv .0068 l CA AA *CC AA nn WVt W TOWaVV / / /1 7977.00 AAAA AA AAAA AA AOAA AA AAAA Aft / ///VV ////VV ////|VV 6? 531.CC TftftT AA / 0/ w TOO AA / v^. 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A* AA I A* V/ w/ AvC* Aa#t AA Ail / V VA /AA <A ViVlV4 4A AV / * A AA w i v i -> y WcaVa i -/rr A1 AA Vi I 4 ' CAC A* w>VV va AA * A W AV C/-H J VW* l c/m nc VTitVV AA A' W/ I V c** *a VWi iV < a /ill/ c^a cc 'JL/iVV A * A/ / CA /A / i Vi W HA *V An FUAT nww i A,HAP AA i hul w nn*kfTT|lA lirAA ?A i i\ut i mv imiu iv * av * a nA,,imy |ftnlUr'-AVV'' 1 II lAT A n Al m |i- V' wv i nuytu hi_a rm mu v * v l\4 I Vi Ml A A * * 1-1 SL 082417 1-18 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Individual Body Weight Data for Female Rats rrtrtr "it 'Tv*- fti-vr kvv(, nru tin TtirMlY AATft _ ArAA ftVtVftl An MTAATIlA i'li l i unm //- " uuau niiiunu Vi* m-jwiiw unm u MrAi'A t'ita ma* nr ta rvr< rnAu /v i aai ami at? aha TT tH_rH*V I I ll J ntl`L i LAL'LVk'LU I MvM AU. ^HUWUn I i VMV i me rvAw yn 1 A V nin L'rt 1 rt V rtA v Vrt 1 1 rt IV pm/ L*n i rtA iV AAV yn i A/ iV A*V wn. 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X AAC 4 A V4VtiV AA CA 44a V4 AAC A/ VVVa/V AA CA 44a VX AHA 4 A VT4a 44 Ae Tf 4Ja / V 100 100 77 100 100 XV A/ XV A/ XV 76 A/ XV 0XV* AMJST PAGE 30 PRINTING HEAD IS JUGT ACCVC NEXT PERFORATION : RETURN wt SL 082423 1-24 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Individual Body Weight Data for Female Rats iA/vw ivititTT* nAf\ni_r fTft thai rr -nunrun aa ur/V't^r f>Ata ui rummL n\ iuwiijv ymn ji it mtmia mLtnk> t1)*a lluv 11*1 nr vncvu in iw rvM nnrn L.AWUvi_,i/ i ivwii a i rtww aai aim Atfftttr Lru_Wum ivtiv rre aa v. v rMAt lC rv*w 1/fl 1 4V1 aaw vnt AAA 4V / DAY Ay A 414 HA*/ un i AT A 41 / AA'1 vn t Aaa teW AAV vni A/ A 4VV CAY AAT 4V/ r)Au um Aa y V4l A#\/ L>n i A VTV n/\ v vm ATC v/ V AftX/ 1A ( A * r T*rf ' / 1 n 4 A V A T e v / V t / a V n / 4A IV yy ii 1^ 14 yA IV 4A IT 15 16 4T 1/ 13 1? 20 21 AA 44 Aa 4V Al 4T AC IV A/ 4W at 4/ AA 4V aa 4/ 30 31 AA V4 AA 34 AC W ^W< AT V/ AA W AA V/ X 41 42 #A TV ia TT 45 46 AC< AA WlVV AAA A/\ V4VaVV 302. 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X AA A AA WTaVV xo.cc A## AA V7T| W AAy aa WlaVV AAT AA V41* VV A/ T AA Wl B VV AAC AA WWa W AAO AA vWa W AAA AA >44a VV AAT AA W/ a VV A#T AA aW X7.X AAA AA WV* VV 370.00 Ay A A A VlV* vv 297.X AAT AA Jl/ a VV AA/ AA V4Va Vv AAA AA 4V/VV ATC AA V/ Va W A/A AA WV* vv 295.00 209.00 ACT AA Wl* VV ACA AA Wv* Vv AAT AA W / a VV Ay A aa JIWivv Ay A AA VlVa Vv AAA AA V44* VV AAT AA V4/ a VV AAA AA WV* VV AAC AA yvJiw AT A AA VI/VV AAA AA w /vV 343.X AfA AA VI/* VV A #T AA VT# t VV 357.X AAA AA W4/ * W AAA AA V4V# VV X7.C0 A/ A AA WVa VV A* A AA VTVaVV A# A AA VTV* W A** AA VTT# VV AT/ AA V/ Va VV A# y AA VTlaVV 342.X AAC AA VW* W A AA AA TWW* VV A<C AA VI Va W aaa aa V4V* w ATA A A v/ v* vv AAA AA V44a VV 394.X 333.00 a#c aa VtVa VV AAA AA V4V*vv AAT AA W4 / a W Ay A AA viv*vv aa/ aa 4W* VV ATC AA V/V# VV AAC AA WV* vv AA y AA WlaVV AAA AA VW. 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X AA* AA wT* VV AA/ AA V4V* W ACA AA W4t Vv #Ay AA T4l* VV ACA A A wv* VV A/# A A WT * VV ACA AA vw* vv ACA AA W4* W Acy AA Wl B VV AAC AA WVa VV AAA AA 4/V* VV AAA AA wv* vv Ay / AA VlVaVV A#C AA VTV* VV A 4 A AA TITa VV AT/ V V/ Va VV AA/ AA v7w# VV A/A AA vv?Vv a*a AA VI ' VV AAA AA WV* vv AA# AA V4T* W A / y AA Wl * VV ATC AA V/ Va W -ACA AA wv* VV A/A AA VO?vv A / C AA WVa VV 359.X #TA AA T/ Va W AAA AA VW* VV A/T AA W/ * VV ACC AA vW* VV A/ A AA W4* W AAA AA V/Va VV ACC AA VWa VV ATA AA w'/ 0* VV A # A AA VTV* VV 401.00 ATA AA V/ Va W A/T AA W/ a VV 426.X ATA /VN v/V* W A/ A AA W4# VV A# A AA VT/aVV AT/ AA V#Va W ATA AA v/ / W 37C.X A # A AA VTV*VV A/ * AA Wl * W A/ T Aft W/ a VV AA V4VaVV A/ A AA vOutW 429.X AAC AA WVa VV 400.00 A#C AA VTV a VV AAA AA wv# vv ACA AA W4B W AT * A A V/ 1 a VV 427.CC ATy a a V/ 1 a W #AA AA IWiVV AAA AA V44 a VV a#a aa VT4# w 325.00 ATA AA V/ V* W AT A/^ 0/T * VV *AC AA VWa W ATA AA v/ v* w 406.00 ATA AA V/ Va W ATA AA V/ Va VV ATT AA wn*W A/ A AA w/ B W #AC Aa TV'W* a VV #AA AA TWa VV AA/ A A V/Va VV ATA AA V/4# VV ATA AA V/ V# W ATA AA V/ V* W #TA AA T/v# vv A / A AA VV4a W ATA AA V; V* VV A.'tA A A W4 * VV # y / aa T1VaVV 533.X 293.X AAA V/V# wAA ACC AA WVa VV ACC AA WVa VV AT/ AA V/ 1 a VV AAT AA W/ a W AA/ AA WV. 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' ' > VV rvnr*A rr . . i vv AlVlA 1 * ///'IVJ / /. noon *, * ' ' 1 * v-. or AAT'Ai ,V` OiVrfl Al' Al'lAr.', 1 T-i-, > . i-(r'i/'. ,-rvv, srt a ,0.-..*>AA r i\ iVn',0 l"rA ftt I f A '.'iVJ 44 V U< AVA'i '`VA 4 Ofl 4V/ , 1(0, TV. li to r i. V/A' /L'/ << a cr y' V.' .'/ a,. AVVA or II WT ni'v.v t A A AT i not At-| '."j Ir<lr,\ *1k1 yFT1 T4 k'T`*J_ i' >'Tv*n,L**, r4 rV jl|u(l"jTi nATfvOAvll a a a Any r 'r-iinii ,, * L I VI'H * A nrv 114,0 1_J ,1 VI 1-33 APPENDIX II Gross and Histopathology Data for Male and Female Rats 1 Month Interim Kill SL 082434 TABLE II-l VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Gross Pathologic Findings in Rats on Long-Term Exposure 30 Day Interim Kill Pathologic Findings Males No visible lesions Focal corneal cloudiness Subpleural 1 to 2 mm sized pale gray foci in the lungs Caudate lobe of the liver appears strangulated and pale colored Vapor Concentration (ppm) 0 10 40 2/4 3/4 2/4 1/4 0/4 0/4 2/4 1/4 1/4 0/4 0/4 1/4 Females No visible lesions Clear fluid in the uterine horns Subpleural 1 to 2 mm sized pale gray foci in the lungs Intestinal nematodiasis 1/4 1/4 3/4 2/4 0/4 0/4 3/4 3/4 1/4 1/4 0/4 1/4 Data listed as number of rats affected/number of rats examined. SL 082435 TABLE 11-2 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Findings in Male Rats on Long-Term Exposure 30 Day Interim Kill Microscopic Examination Focal chronic interstitial nephritis Focal renal tubular collapse and atrophy Focal dilated renal tubules with eosinophilic staining casts Focal chronic hepatitis Focal subacute to chronic interstitial pneumonia Chronic peribronchial lymphoid cellular infiltrate Focal chronic tracheitis Focal chronic interstitial prostatitis Intestinal nematodiasis Chronic focal myocarditis Pituitary . _and microcyst in the pars dista.xs Vapor Concentration (ppm) 0 _10 40 0/A 0/4 2/4 2/4 2/4 2/4 4/A 2/4 2/4 3/4 2/4 3/4 3/4 2/4 4/4 4/4 2/4 3/4 2/4 1/4 4/4 2/4 2/4 0/4 0/4 4/4 2/4 4/4 2/4 1/4 1/4 0/4 0/4 Data listed as number of rats affected/number of rats examined. SL 082436 TABLE I1-3 VTNYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Findings in Female Rats on Long-Term Exposure 30 Day Interim Kill Vapor Concentration (ppm) Microscopic Examination 0 10 40 Focal renal tubular collapse and atrophy 1/A 2/4 0/4 Focal granular casts within the renal tubules Focal chronic hepatitis 4/4 4/4 2/4 3/4 2/4 1/4 Focal subacute to chronic interstitial pneumonia 3/4 3/4 2/4 Focal peribronchial lymphoid cellular infiltrate Focal chronic tracheitis Intestinal nematodiasis Focal chronic urocystitis Focal chronic pancreatitis Focal chronic myocarditis 3/4 4/4 4/4 1/4 3/4 2/4 0/4 0/4 2/4 1/4 0/4 0/4 1/4 0/4 0/4 0/4 1/4 0/4 Data listed as number of rats affected/number of rats examined. SL 082437 TABLE III-l VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Gross Pathologic Findings in Rats on Long-Term Exposure 6 Month Interim Kill Pathologic Findings Males No visible lesions Focal corneal cloudiness Subpleural 1 to 2 mm sized pale gray foci in the lungs Pneumonia in the dependent lobes of the lung Intestinal nematodiasis Kidneys increased in size and pale colored Linear pale area in one lobe of the liver 1 cm long Females No visible lesions Clear fluid in the uterine horns Endometrial polyp 1 mm diameter Subpleural 1 to 2 mm sized pale gray foci in the lungs Intestinal nematodiasis Liver pale colored with accentuation of the lobular pattern Focal corneal cloudiness Vapor Concentration (ppm) 0 25 75 1/5 3/5 0/5 3/5 0/5 1/5 0/5 0/5 1/5 1/5 0/5 0/5 3/5 1/5 3/5 2/5 1/5 2/5 0/5 0/5 1/5 0/5 1/5 2/5 2/5 2/5 2/5 0/5 0/5 1/5 1/5 2/5 1/5 4/5 1/5 1/5 0/5 1/5 1/5 0/5 1/5 0/5 Data listed as number of rats affected/numb er of rats examined. SL 082439 TABLE 111-2 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Findings in Male Rats on Long-Term Exposure 6 Month Interim Kill Vapor Concentration (ppm; Microscopic Examination Focal chronic interstitial nephritis 0 25 75 2/5 0/5 0/5 Focal renal tubular collapse and atrophy; minimal moderate 3/5 4/5 4/5 2/5 1/5 1/5 Focal dilated renal tubules with eosinophilic staining casts; minimal moderate 3/5 4/5 4/5 2/5 1/5 1/5 Focal chronic hepatitis; minimal Focal subcapsular necrotic hepatitis 5/5 4/5 4/5 0/5 0/5 1/5 Minimal increase in cytoplasmic vacuolation of the hepatocytes 0/5 1/5 4/5 Focal subacute to chronic interstitial pneumonia 0/5 0/5 1/5 Acute suppurative pneumonia 1/5 0/5 1/5 Chronic peribronchial lymphoid cellular infiltrate Focal chronic tracheitis Focal acute tracheitis Focal chronic interstitial prostatitis Intestinal neraatodiasis Chronic focal myocarditis Unilateral chronic ophthalmitis Focal chronic pancreatitis 4/5 1/5 1/5 0/5 1/5 1/5 1/5 1/5 4/5 1/5 0/5 1/5 0/5 0/5 0/5 0/5 3/5 2/5 0/5 1/5 1/5 0/5 0/5 0/5 Mononuclear cell infiltrate in the epididymides 1/5 0/5 0/5 Data listed as number of rats affected/number of rats examined. SL 082440 TABLE III-3 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Findings in Female Rats on Long-Term Exposure 6 Month Interim Kill Vapor Concentration (pan) Microscopic Examination Focal chronic interstitial nephritis Focal renal tubular collapse and atrophy; minimal moderate Focal granular casts within the renal tubules Focal dilated renal tubules with eosinophilic staining casts; minimal moderate Focal chronic hepatitis Minimal increase in cytoplasmic vacuolation of the hepatocytes 0 25 75 0/5 2/5 3/5 2/5 2/5 3/5 1/5 0/5 0/5 5/5 3/5 2/5 1/5 3/5 3/5 1/5 0/5 0/5 5/5 4/5 5/5 0/5 2/5 4/5 Focal subacute to chronic interstitial pneumonia 1/5 2/5 3/5 Focal peribronchial lymphoid cellular infiltrate 5/5 4/5 3/5 Focal chronic tracheitis 0/5 2/5 1/5 Intestinal nematodiasis 0/5 1/5 0/5 Focal chronic urocystitis 1/5 0/5 0/5 Focal subacute pancreatitis 4/5 1/5 0/5 Focal chronic myocarditis 0/5 1/5 0/5 Endometrial polyp 0/5 0/5 1/5 Data listed as number of rats affected/number of rats examined. SL 082441 TABLE IV-l VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Gross Pathologic Findings in Rats on Long-Term Exposure 12 Month Interim Kill Pathologic Findings Males No visible lesions Focal corneal cloudiness Subpleural 1 to 2 mm sized pale gray foci in the lungs Kidneys increased in size and pale colored with mottling of the cortex Testicular edema, bilateral Decreased adipose tissue in the abdominal cavity Tumor of the adrenal medulla, unilateral Focal fat necrosis within the epididymal fat pad Vapor Concentration (ppm' 0 25 75 1/5 0/5 0/5 2/5 2/5 1/5 1/5 1/5 0/5 3/5 2/5 3/5 1/5 0/5 0/5 0/5 2/5 3/5 0/5 0/5 1/5 0/5 0/5 1/5 Females No visible lesions Clear fluid in the uterine horns Ovarian cysts with hydrometra Subpleural 1 to 2 mm sized pale gray foci in the lungs Liver pale colored with accentuation of the lobular pattern 2/5 0/5 0/5 0/5 1/5 0/5 0/5 0/5 1/5 1/5 0/5 0/5 0/5 5/5 5/5 SL 082443 TABLE IV-1 (continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Gross Pathologic Findings in Rats on Long-Term Exposure 12 Month Interim Kill Pathologic Findings Females Kidneys increased in size Vapor Concentration (ppm) 0 25 75 0/5 1/5 3/5 Kidney with a 5 mm fluid-filled cyst in the cortex 0/5 1/5 0/5 Subcutaneous tumorous mass in the mammary gland region 1/5 0/5 0/5 Mammary gland hyperplasia with galactocele formation Suppurative oophoritis, unilateral Pituitary gland, increased in size 0/5 1/5 0/5 0/5 1/5 0/5 0/5 1/5 0/5 White firm tumorous masses in the vagina and cervix % cm diameter 0/5 0/5 1/5 Endometrial cysts 1/5 0/5 1/5 Data listed as number of rats affected/numb er of rats examined. SL 082444 TABLE IV-2 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Findings in Male Rats on Long-Term Exposure 12 Month Interim Kill Vapor Concentration (ppm' Microscopic Examination 0 25 75 Focal chronic interstitial nephritis 4/5 2/5 2/5 Focal renal tubular collapse and atrophy; minimal moderate 2/5 3/5 5/5 3/5 2/5 0/5 Focal dilated renal tubules with eosinophilic staining casts; minimal moderate Focal chronic hepatitis; minimal 2/5 3/5 5/5 3/5 2/5 0/5 5/5 4/5 4/5 Minimal increase in cytoplasmic vacuolation of the hepatocytes 0/5 3/5 5/5 Focal subacute to chronic interstitial pneumonia 4/5 3/5 4/5 Chronic peribronchial lymphoid cellular infiltrate 5/5 5/5 5/5 Intestinal nematodiasis 1/5 2/5 2/5 Chronic focal myocarditis with myocardial degeneration and fibrosis 2/5 2/5 2/5 Focal chronic pancreatitis 1/5 1/5 1/5 Testicular hypoplasia and edema Focal adrenal cortical cyst 1/5 0/5 0/5 1/5 0/5 0/5 Tumor of the adrenal medulla (pheochromocytoma), unilateral 0/5 0/5 2/5 Focal fat necrosis in the epididymal fat pad 0/5 0/5 1/5 Data listed as number of rats affected/number of rats examined. SL 082445'-. TABLE IV-3 VINYLIOENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Findings in Female Rats on Long-Term Exposure 12 Month Interim Kill Vapor Concentration (ppm) Microscopic Examination Focal chronic interstitial nephritis 0 25 75 2/5 2/5 2/5 Focal renal tubular collapse and atrophy; minimal moderate 4/5 4/5 4/5 0/5 1/5 1/5 Focal granular casts within the renal tub' s 4/5 4/5 1/5 Foe dilated renal tubules with eosr. ohilic staining casts; minimal moderate 4/5 4/5 4/5 0/5 1/5 1/5 Focal chronic hepatitis 5/5 5/5 5/5 Minimal increase in cytoplasmic vacuolation of the hepatocytes 0/5 5/5 5/5 Focal subacute to chronic interstitial pneumonia 5/5 3/5 1/5 Focal peribronchial lymphoid cellular infiltrate Intestinal nematodiasis Focal subacute pancreatitis 5/5 5/5 5/5 1/5 1/5 1/5 1/5 0/5 2/5 Focal chronic myocarditis with myocardial degeneration and fibrosis 1/5 0/5 0/5 Subcutaneous tumor, carcinosarcoma probably of mammary gland origin Ovarian tumor, granulosa cell 1/5 0/5 0/5 1/5 0/5 0/5 SL 082446 TABLE IV-3 (continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Findings in Female Rats on Long-Term Exposure 12 Month Interim Kill MicroscoDic Examination Adrenal gland, hematocysts formation in the cortex Focal pituitary adenoma with sinusoidal dilatation Adrenal cortex, hyperplastic focus Focal squamous metaplasia of the endometrium Body of the uterus without a lumen associated with hydrometra and ovarian cysts Fibroma of the vagina and cervix Mammary gland hyperplasia with galactocele formation Suppurative oophoritis, unilateral Vapor Concentration (ppm) 0 25 75 1/5 1/5 1/5 1/5 1/5 2/5 1/5 0/5 0/5 0/5 3/5 1/5 0/5 0/5 1/5 0/5 0/5 1/5 0/5 1/5 0/5 0/5 1/5 0/5 Data listed as number of rats affected/number of rats examined. SL 082447 APPENDIX V TEST MATERIAL ANALYSIS SL 082448 TABLE V-l VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Typical Analysis of Vinylidene Chloride and Calculated Chamber Concentrations of Impurities Impurities Vinyl chloride Vinyl bromide cis 1,2-dichloroethylene trans 1,2-dichloroethylene 1.1.1 trichloroethane 1.1.2 trichloroethane Inhibitors Hydroquinone monomethyl ether Vinylidene Chloride Analysis* 0-0.13%** 0-14 ppm 0.003-0.16% 0.01-0.3% 0-8 ppm 0-0.9 ppm 130-400 ppm*** Maximum Concentration (Calculated) in 75 ppm Atmosphere _____________ 113 ppb 1.1 ppb 126 ppb 237 ppb 0.5 ppb 0.05 ppb 121 ppb 74.41 ppm * Gas chromatographic analysis ** Analyses from batches were between 2 and 66 ppm except for one at 13 00 ppm. *** There were single determinations of 558 and 1600 ppm for single containers from the last portions of two batches used. SL 082449 APPENDIX VI Individual Animal Data Hematology SL 082450 Cone. (ppm) 0 25 75 TABLE VI-1 VI NYU DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STODY IN RATS Hematology Values for Hale Rats Exposed for 6 Months SI ide Number 11 12 13 14 15 Mean iS.O. 1 2 3 4 5 Mean +S.D. 21 22 23 24 25 Mean S.D. HCT % 49.0 53.5 56.0 53.0 57.0 53.7 3.1 53.0 53.0 53.0 53.0 54.0 53.2 0.4 54.0 54.0 55.0 55.0 54.0 54.4 0.5 RBC XI0* 7.33 7.99 8.67 7.83 8.19 8.00 0.49 7.81 6.48 7.79 7.58 7.65 7.46 0.56 6.58 8.19 7.68 8.19 7.87 7.70 0.66 Hgb q/100 cc. 15.9 17.0 17.7 17.1 17.8 17.1 0.8 17.1 17.3 17.4 17.0 18.0 17.4 0.4 17.2 17.4 17.1 17.7 16.9 17.3 0.3 NBC XI03 13.1 10.5 10.6 10.2 11.2 11.1 1.2 7.7 12.8 9.5 12.2 9.3 10.3 2.1 8.6 13.7 10.2 11.4 39.9 16.8 13.1 Neut sEg B/J 18 0 16 0 14 0 16 0 90 15 0 DIFFERENTIAL COUNT Lyro. Hon. 75 6 80 4 81 3 81 1 87 2 31 3 18 0 17 0 13 0 22 0 22 0 18 0 77 76 82 81 78 78 2 3 2 5 0 2 80 10 0 21 0 16 0 40 0 19 0 88 82 74 81 51 75 4 7 3 3 9 5 Eo 5 1 0 2 2 2 1 3 3 3 1 0 2 0 1 2 0 0 1 Bas. 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Remarks 1 nuc RBC Ho statistically significant differences from control mean by analysis of variance and Dunnett's test, p <0.05. SL 082451 TABLE VI-2 VINYUDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Hematology Values for Female Rats Exposed for 6 Months Cone. ieeni 0 25 75 Slide Number DIFFERENTIAL COUNT HCT RBC Hgb WBC Neut S XI 0i q/100 cc. XI0* SEG flTJ kxt Mon. Eos. Bas. Remarks 16 47.5 7.49 16.3 17 56.5 8.02 17.1 IB 53.0 7.39 17.1 19 52.0 7.03 16.2 20 49.5 6.77 16.0 Hean S.O. 51.7 3.4 9.34 0.48 16.5 0.5 6.8 8.7 11.9 12.0 10.5 10.0 2.2 9 10 9 7 9 9 0 0 0 0 0 0 87 84 81 91 87 86 220 420 32 0 I1 0 310 410 6 48.0 6.52 15.9 7 46.5 6.42 15.0 8 56.0 7.55 18.2 9 50.0 6.51 16.5 10 48.0 6.23 15.4 Mean tS.D. 49.7 3.7 6.65 0.52 16.2 1.3 6.4 6.3 11.4 11.1 4.8 8.0 3.1 20 21 14 19 14 18 0 0 0 0 0 0 74 76 79 75 83 77 51 0 300 520 51 0 21 0 410 26 50.0 7.03 16.6 27 54.0 7.00 17.9 28 49.5 7.30 16.4 29 52.5 8.17 18.0 30 57.5 9.08 1B.0 Mean iS.D. 52.7 3.3 7.72 0.90 17.4 0.8 7.6 9.3 10.4 9.2 11 .3 9.6 1.4 9 16 10 19 10 13 0 0 0 0 0 0 85 80 84 79 86 83 330 220 51 0 110 31 0 31 0 No statistically significant differences from control mean by analysis of variance and Dunnett's test, p <0.05. SL 08245 TABLE VI-3 VINYL1DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Hematology Values for Hale Rats Exposed for 12 Months Animal Number Cone. (pH. DIFFERENTIAL COUNT HCT RBC Hgb WBC Neut X XI06 q/100 CC. XIO3 SEG B7J Lym. Mon. Eos. Bas. Rema r k s 74-1135 1136 1137 1138 1139 0 Mean S.D. 49.5 49.0 62.5 49.5 52.5 50.6 1.7 8.10 8.00 8.59 8.63 9.08 8.48 0.44 15.7 16.1 17.0 16.2 17.1 16.4 0.6 12.6 25 2/0 9.2 20 0 9.0 15 0 7.9 13 0 8.5 14 0 9.4 17 1.8 0 73 77 84 93 84 82 000 300 1 00 220 110 1 00 74-1533 1534 1535 1536 1537 25 74-1335 1336 1337 1338 1339 75 Mean iS.D. Mean S.O. 54.0 49.0 47.0 50.0 53.0 50.6 2.9 53.5 53.0 53.5 53.5 52.0 53.1 0.7 8.23 8.93 8.46 8.36 8.27 8.46 0.28 8.96 8.52 9.29 9.15 8.66 8.92 0.32 17.9 17.3 16.4 16.3 17.8 17.1 0.8 17.6 17.3 18.1 17.3 16.8 17.4 0.5 11.0 14 0 8.5 25 1/0 6.4 33 0 5.5 21 0 7.1 15 0 7.7 22 2.1 0 10.1 17 0 10.0 6 0 14.0 12 1/0 10.1 16 0 6.7 27 0 10.2 2.6 16 0 85 67 67 74 84 75 79 88 87 82 70 81 01 0 1 60 000 320 001 I 20 220 060 000 110 1 20 t 20 No statistically significant differences from control mean by analysis of variance and Dunnett's test, p <0.05. SL 082453 TABLE VI-4 VINYUDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Hematology Values for Female Rats Exposed for 12 Months Number Cone. jpgs) DIFFERENTIAL COUNT HCT RBC Hob WBC Neut % XI0* q/100 cc. X10s SEG B/J klSL. Mon. Eos. Bas. Remarks 74-1229 1230 1231 1232 1233 0 Mean 'S.D. 44.0 47.0 47.0 48.0 46.5 46.5 1.5 7.02 7.56 7.52 7.30 7.23 7.34 0.22 14.7 15.4 15.5 15.8 15.2 15.3 0.4 7.5 8 7.1 10 9.4 20 6.7 16 5.2 15 7.2 14 1.5 0 0 0 0 0 0 90 85 00 75 85 83 200 320 00 0 540 000 21 0 74-1633 1634 1635 1636 1637 25 74-1430 1431 1432 1433 1434 75 Mean +S.D. Mean <S.D. 50.5 48.5 43.5 50.5 48.5 4B.3 2.9 46.0 46.0 47.0 48.0 45.0 46.4 1.1 8.24 7.26 7.38 8.20 7.63 7.74 0.46 7.80 7.83 7.75 8.11 7.73 7.84 0.15 16.3 15.4 14.1 16.7 16.7 15.8 1.1 15.0 15.6 15.9 15.5 15.3 15.5 0.3 5.6 3.7 2.8 4.0 4.1 4.0* 1.0 10 10 14 13 10 11 0 0 0 0 0 0 6.7 11 1/0 5.4 24 1/0 8.3 21 0 7.3 14 0 5.3 24 0 6.6 19 1.3 0 87 88 83 86 89 87 85 75 74 86 72 78 030 II0 1 20 0I 0 01 0 020 1 20 000 140 000 220 120 `Significantly different from control mean by analysis of variance and Dunnett's test, p <0,05. CO tr1 O oo to Ul SL 082455 TABLE VI-5 VINYL!DENE CHL0RI0E: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Hematology Values for Male Rats Exposed for 24 Months Animal Number Cone. (ppm) DIFFERENTIAL COUNT HCT RBC Hgb WBC Neut % XI 0* q/100 cc. XI03 SCG B/J Lym. Mon. Eos. 74-1201 1202 1203 1204 1205 1206 1207 1208 1209 1210 0 Mean 'S.O. 46.0 45.0 52.0 48.0 49.0 48.0 23.0 45.0 50.0 47.0 45.3 8.1 8.11 7.07 8.84 7.93 7.53 7.62 4.77 7.48 8.36 7.36 7.51 1.1 14.0 14.5 16.2 15.5 15.1 15.3 8.9 14.6 16.3 15.6 14.6 2.1 28.9 34 1/1 13.8 37 0 11.2 30 0 14.0 41 0 28.5 29 0 22.0 25 0 25.2 60 0 20.8 19 0 11.7 43 0 10.9 31 0 18.7 35 0 7.2 58 52 69 52 68 73 40 76 53 64 61 6 7 1 5 3 1 0 4 1 3 3 74-1603 1604 1605 1606 1607 1608 1609 1610 1611 1612 25 Mean > S . D. 46.0 35.0 40.0 45.0 48.0 50.0 45.0 46.0 30.0 49.0 43.4 6.5 7.73 6.03 6.79 7.42 8.42 7.96 6.95 7.14 4.50 7.97 7.09 1.1 14.9 12.6 13.7 15.5 15.9 16.0 14.4 14.8 9.3 16.5 14.4 2.1 28.3 14.2 12.2 11.9 11.8 20.3 14.1 15.7 30.9 13.7 17.3 6.9 13 30 33 50 22 38 50 42 65 41 38 0 0 0 0 0 0 0 0 0 0 0 81 65 62 45 73 61 44 57 32 64 58 7 5 5 3 1 1 3 1 2 4 3 74-1406 1407 1408 1409 1410 1411 1412 1413 1414 1415 75 Mean 'S.D. 38.0 48.0 52.0 46.0 53.0 41.0 43.0 53.0 51.0 48.0 47.3 5.3 6.44 7.64 7.84 7.32 8.16 6.72 7.39 8.53 8.31 7.77 7.61 0.67 12.4 15.6 16.6 16.3 16.2 14.7 14.7 17.1 17.0 15.8 15.6 1 .4 23.9 41 1/0 12.2 29 0 15.1 59 0 13.1 52 0 23.1 47 0 8.9 39 0 13.6 58 0 12.7 23 0 13.0 29 0 15.8 21 0 15.1 38 0 4.8 51 65 57 42 47 54 40 72 68 77 57 7 3 3 3 5 6 2 2 3 2 4 No statistically significant differences from control mean by analysis of variance and Dunnett's test, p <0.05. 0 4 0 2 0 1 0 1 3 2 1 1 0 0 2 4 0 3 0 1 1 1 0 3 1 3 1 1 0 2 0 0 l Bas. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0, 0 0 0 0 0 0 0 0 0 0 O O O O O O O O O O O O O Q O O u lO O O O o o o o o o o o o o o SL 0824S6 TABLE VI-6 VINYL I DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Hematology Values for Female Rats Exposed for 24 Months Animal Number Cone. (ppm) DIFFERENTIAL COUNT HCT RBC Hgb WBC Neut I XI0* q/100 cc. X10 SEG 17J L&- Mon. 74-1297 1298 1299 1300 1301 1302 1303 1304 1305 1306 0 Mean tS.D. 44.0 27.0 40.0 40.0 31.0 38.0 47.0 48.0 33.0 42.0 39.0 6.9 . 7.15 3.23 6.66 6.71 4.99 5.53 6.94 7.58 4.96 6.65 6.04 1.3 14.1 8.0 13.5 13.9 9.9 12.9 15.0 15.7 10.6 13.6 12.7 2.4 10.3 32 0 21.8 42 9/1 12.2 38 0 7.4 54 0 9.2 34 0 13.1 35 0 11.0 10.1 31 46 0 0 16.6 34 0 19.9 52 0 13.2 40 1/0 4.8 64 45 58 41 62 64 65 50 64 45 56 3 2 2 3 3 1 2 2 2 3 2 74-1699 1700 1701 1702 1703 1704 1705 1706 1707 1708 25 Mean +S.D. 30.0 48.0 36.0 29.0 58.0 40.0 43.0 39.0 36.0 40.0 39.9 8.5 4.21 7.14 6.03 4.88 9.30 6.55 6.63 7.14 . 5.42 6.07 6.34 1.41 9.3 15.0 11.7 10.3 19.7 14.0 14.2 14.0 11.7 13.6 13.4 2.9 27.1 47 2/0 7.7 24 0 12.7 43 1/0 4.8 18 0 18.6 25 0 16.5 21 0 16.6 49 2/0 8.0 51 0 19.8 34 2/0 18.9 44 0 15.1 36 1/0 6.8 46 69 50 79 72 57 43 47 59 53 58 5 2 5 2 0 1 4 0 4 1 2 74-149B 1499 1500 1501 1502 1503 1504 1505 1506 1507 75 Mean iS.O. 42.0 44.0 45.0 40.0 40.0 33.0 40.0 43.0 43.0 43.0 41.3 3.4 6.41 6.96 7.22 6.61 6.35 5.64 6.55 6.55 7.04 7.26 6.66 0.49 13.5 14.3 14.8 13.6 13.1 11.7 12.9 14.8 14.5 14.7 13.8 1.0 14.2 40 0 26.0 49 1/0 14.9 23 I/O 15.0 50 1/0 8.4 42 0 15.5 36 I/O 9.4 36 0 14.4 56 0 18.0 48 0 7.5 38 0 14.3 42 0 5.4 52 43 73 44 54 59 60 41 46 55 53 7 2 3 4 4 2 4 3 1 6 3 No statistically significant differences from control mean by analysis of variance and Dunnett's test, p <0.05. Eos. i i 2 1 1 0 1 2 0 0 1 0 5 1 1 3 16 2 2 1 2 3 1 5 0 1 0 2 0 0 5 3 2 Bas. APPENDIX VII Individual Animal Data Urinalysis SL 082457 Cone. (PP") 0 25 TABLE VIM VINYL!DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Urinalysis Values for Male Rats Exposed for 6 Months Specific Gravitv fiH Sugar 1.044 7.0 _ 1.034 7.0 - 1.022 7.0 - 1.034 6.5 - 1.034 7.0 - Mean `S.D. 1.0336 0.0078 Albumin 4+4 +4+ 44 4+4 +44 Ketones _ - Bilirubin - 1.025 7.5 1.039 6.5 - 1.039 6.5 - 1.036 7.0 - 1.048 7.0 - Mean iS.D. 1.0378 0.0135 + 4+ + 44 44 444 44 + . - _ - Blood - _ _ 75 1.038 7.0 _ 1.027 7.0 - 1.022 7.0 - 1.054 8.0 - 1.048 7.0 - Mean <S.D. 1.0374 0.0083 + 44 44 + 44 + 4+4 + 44 _ - -_ -_ --- No statistically significant difference from control mean by analysis of variance and Dimnett's test, p <0.05 SL 082458 TABLE VII-2 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Urinalysis Values for Female Rats Exposed for 6 Months Cone. (PP"1? 0 Mean iS.D. Specific Gravity 1.016 1.024 1.036 1.036 1.014 1.0252 0.0105 EH 6.0 6.0 6.0 ` 6.0 6.5 Suqar - Albumin Trace Trace Trace Trace Ke tones - Bilirubin - Blood - 25 1.021 7.0 - 1.034 6.0 - 1.033 6.5 - 1.038 6.0 - 1.044 6.0 - Mean S.D. t.0158 0.0056 75 1.020 6.5 - 1.010 6.0 - 1.013 6.0 - 1.007 6.0 - 1.019 6.0 - Mean ^S.D. 1.0138 0.0056 Trace 4 4+ Trace Trace 4 44 Trace 4 4 - - - - -- ----- _- ----- No statistically significant difference from control mean by analysis of variance and Dunnett's test, p <0.05. SL 082459 0$*190 IS TABLE VI1-3 V1NVL10ENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND 0NC0GEH1CIIY STUDY IN RATS Urinalysis Values for Hale Rats Exposed for 12 Months Cone. (ppm) 0 Animal Humber 74-1135 Specific Gravity EH Suqar 1.033 6.0 - 1)36 1.034 6.5 - 1137 1.015 7.0 - 1138 1.013 6.5 - 1139 1.029 7.5 - Hean 1.0248 S.D. 0.0101 25 74-1533 1.043 6.5 - 1534 1.013 6.5 - 1535 1 .006 5.5 - 1536 1.019 7.0 - 1537 1.010 6.0 - Mean 1.0364 S.D. 0.0112 Albumin 3+ 3+ 24 3+ 24 Ketones - Bilirubin " - 3+ 3+ 3+ 3+ 2+ - - 75 74-1335 1.022 6.0 - 3+ - 1336 1.029 6.5 - 34 - 1337 1.037 7.0 - 34 - 1338 1.044 7' - 34 - 1339 1.050 6.0 - 34 - Hean 1.0182 >S.D. 0.0)47 - * - Ho statistically significant difference from control mean by analysis of variance and Dunnett's test, p <0.05. Blood small smal 1 trace small mod. ~ - SL 082461 TABLE VII-4 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Urinalysis Values for Female Rats Exposed for 12 Months Cone. (PP">) 0 Animal Number 74-1229 Specific Gravity Etl Sugar 1.035 7.0 - 1230 1.034 6.0 - 1231 1.033 6.5 - 1232 1.033 6.0 - 1233 1.021 7.0 - Mean +S.D. 1.0312 0.0058 Albumin 2+ 2+ 2+ 2* 2+ Ketones - - Bilirubin - 26 1633 1.022 7.0 _ 3+ 1634 1.041 6.0 - 2+ - 1635 1.013 5.5 - 2+ - 1636 1.006 6.0 - 3+ - 1637 1.028 7.5 - 3+ - Mean S.O. 1.0228 0.013J _ - 75 74-1430 1.040 6.5 _ 3+ _ 1431 1.025 6.5 - 3+ - 1432 1.031 7.0 - 3+ - 1433 1.009 6.5 - 2+ - 1434 1.009 6.0 - 2+ - Mean +S.D. 1.0220 0.0135 _ - - No statistically significant difference from control mean by analysis of variance and Dunnett's test, p <0.05. Blood - smal 1 _ - _ large large smal 1 small TABLE 11-5 V1NYL10ENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Urinalysis Values for Male Rats Exposed for 24 Months Cone. (pn>) 0 Animal Number 74-1201 1202 1203 1204 1205 1206 1207 1208 1209 1210 Mean iS.D. Specific Gravity 1.020 1.034 1.027 1.032 1.049 1.017 1.020 1.026 1.021 1.0273 0.0099 e!i Suyar unable to obtain sample 6.5 6.0 - 6.0 6.0 - 6.0 6.0 6.0 7.0 6.0 Albumin 3+ 3+ 3+ 3+ 3+ 3+ 3+ 3+ 3v Ketones - - - Bilirubin ~ - 25 74-1603 1.034 6.0 1604 1.038 6.0 - 1605 1.019 6.0 - 1606 1607 1.020 1.018 6.5 6.0 - 1608 1.033 6.0 - 1609 1610 1.023 1.045 8.0 6.0 - 1611 1.021 6.0 - 1612 1.026 6.0 Mean 1.0267 S.D. 0.0089 75 74-1406 1407 1.023 1.023 6.5 6.0 - 1408 1.038 6.0 - 1409 1410 1411 1412 1413 1.019 1.014 1.025 1.020 1.034 6.0 6.5 6.0 6.0 7.0 - 1414 1.029 6.0 - 1415 1.042 6.0 Mean 1.0277 JS.0. 0.0093 3+ 3c 3+ 3+ 3+ 3+ " 3+ 3* 3+ 3+ 3+ 3+ 3+ 3+ 3t 3+ 3+ 3+ 3+ 3* - " - * " ~ " ' - No statistically significant differences from control mean by analysis of variance and Dunnett's test, p <0.05. ELI ood " * - - Urobilinogen 1.0 0.1 1.0 0.1 1.0 1.0 1.0 1.0 1.0 - 1.0 - 1.0 - 0.1 n.i - l .0 - 0.1 0.1 - 0.1 - 1.0 0.1 - 1.0 1.0 ~ 0.1 0.1 ~ 1.0 - 1.0 * 1.0 - 1.0 o.t 1.0 cn f o CD if* <T\ to SL 082463 TABLE VII-6 VINYL IDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Urinalysis Values for Female Rats Exposed for 24 Months Cone. Animal Number 74-1297 1298 1299 1300 1301 1302 1303 1304 1305 1306 Mean S.D. Specific Gravity pH Suqar 1.043 6.0 > 1.032 6.0 - 1.028 6.5 - 1.022 6.5 - 1.039 6.0 - 1.042 6.0 - 1.048 6.0 - 1.026 6.0 unable to obtain sample 1.025 7.0 1.0339 0.0093 Albumin 3+ 3+ 2+ 3+ 3+ 3+ 3+ 3+ 2+ Ketones - Bilirubin - 74-1699 1.049 6.0 _ 1700 1.045 6.0 - 1701 1.035 6.0 _ 1702 1.038 6.5 - 1703 1.033 6.0 - 1704 1.044 7.0 - 1705 1.033 7.0 - 1706 1.030 7.0 - 1707 1.032 6.5 - 1708 1.028 6.5 Mean 1.0302 +S.D. 0.0108 3+ _ 3+ 3+ 3+ 3+ 3+ 3+ 3+ 3+ 3+ _ - 74-1498 1499 1500 1501 1502 1503 1504 1505 1506 1507 Mean S.D. 1.021 1.020 1.029 1.035 1.016 1.032 1.038 1.047 1.044 1.020 1.0367 0.0071 6.0 _ 5.5 6.0 6.0 6.5 - 6.5 6.0 _ 6.0 6.0 - 6.5 - 3+ _ 3+ 3+ 3+ 3+ 3+ 3+ 3+ - 3* - 3+ - .. - No statistically significant difference from control mean by analysis of variance and Dunnett's test, p<0.0S. Blood - Urobi1inoqen 0.1 1.0 1.0 1.0 1.0 1.0 1.0 0.1 1.0 1.0 - 0.1 - 1.0 _ 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 0.1 1.0 - 1.0 - 0.1 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 TABLE VIII-1 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS SGPT Values for Rats Exposed for 2 Weeks Animal Number MALES Cone. .(eppl) SGPT mU/ml Animal Number FEMALES Cone. (ppm) SGPT mU/ml IK 2K 8K 9K -tag K 1L 2L 3L 4L 5L 501H 502H 503H 504H 597H 0 0 0 0 0 Mean +S.D. 10 10 10 10 10 Mean +S.D. 40 40 40 40 40 Mean S.D. 36 43 33 43 30 37.0 5.9 30 47 39 30 42 37.6 7.5 32 31 26 30 26 29.0 2.8 101K 102K 103K 104 K 105K 1 OIL 102L 103L 104L 105L 403H 404H 405H -tag H -tag H 0 0 0 0 0 Mean 10 10 10 10 10 Mean iS.D. 40 40 40 40 40 Mean +S.D. 40 37 30 30 27 32.8 5.4 40 35 38 39 35 37.4 2.3 26 35 36 29 30 31.2 4.2 No significant difference from control mean by analysis of variance and Dunnett's test, p <0.05. SL 082465 TABLE VII1-2 VINYLIDENE CHLORIDE: A CHRONIC: INHALATION TOXICITY AND ONCOGENICITY :STUDY IN RATS Clinical Chemistry for Male Rats Exposed for 30 days Animal Number Cone. IP_Prc) BUN mq/100ml SGPT mU/ml Aik. Phos. mU/ml 74-1119 74-1120 74-1121 74-1122 0 0 0 0 Mean S.D. 23 27 17 17.5 21.1 4.8 34 32 29 27 30.5 3.1 144 121 149 150 141.0 13.6 74-1521 74-1522 74-1523 74-1524 10 23 10 22.5 10 26 10 20 Mean 22.9 $.D. 2.5 27 27 29 34 29.3 3.3 184 1 50 192 166 173.0* 18.8 74-1319 74-1320 74-1321 74-1322 40 20.5 40 18 40 23 40 21 Mean 20.6 S.D. 2.1 25 29 27 26 26.8 1.7 117 109 132 111 117.3 10.4 tically significant difference from control mean by analysis of variance and Dunnett's te p <0. TABLE VI11-3 VI NYLI DENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Clinical Chemistry Values for Female Rats Exposed for 30 Days Animal Number 74-1218 74-1219 74-1220 74-1221 74-1618 74-1619 74-1620 74-1621 74-1418 74-1419 74-1420 74-1421 Cone. (PP>) 0 0 0 0 10 10 10 10 40 40 40 40 Mean +S.D. Mean +S.D. Mean S.D. BUN mg/100ml 22 21 25 23 22.8 1 .7 20 25.5 22.5 21 22.3 2.4 18 26.5 27.5 23.5 23.9 4.3 SGPT mU/ml 27 20 22 26 23.8 3.3 22 24 25 25 24.0 1.4 20 25 28 20 23.3 3.9 Aik. Phos mU/ml 102 75 89 151 104.3 33.0 128 155 102 101 121.5 25.6 100 127 136 93 114.0 20.7 No statistically significant difference from control mean by analysis of variance and Dunnett's test, p <0.05. SL 082467 TABLE VMI-4 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY1 AND ONCOGENICITY STUDY IN RATS Clinical Chemistry Values for Rats Exposed for 7 Weeks HALE RATS Animal Number 74-1119 74-1120 74-1121 74-1122 74-1521 74-1522 74-1523 74-1524 74-1319 74-1320 74-1321 74-1322 FEMALE RATS 74-1218 74-1219 74-1 220 74-1221 74-1618 74-1619 74-1620 74-1621 74-1418 74-1419 74-1420 74-1421 Cone. <PP") 0 0 0 0 10 10 10 10 40 40 40 40 0 0 0 0 10 10 10 10 40 40 40 40 Mean iS.D. Mean S.D. Mean .'S.D. Mean 'S.D. Mean iS.O. Mean tS.D. BUN mg/100ml 23 27 17 17.5 21.1 4.8 23 22.5 26 20 22.9 2.5 20.5 18 23 21 20.6 2.1 22 21 25 23 22.8 1.7 20 25.5 22.5 21 22.3 2.4 18 26.5 27.5 23.5 23.9 4.3 SGPT mU/ml 34 32 29 27 30.5 3.1 27 27 29 34 29.3 3.3 25 29 27 26 26.8 1.7 27 20 22 26 23.8 3.3 22 24 25 25 24.0 1.4 20 25 28 20 23.3 3.9 Aik. Phos. mU/ml 144 121 149 150 141 .0 13.6 184 150 192 166 173.0 18.8* 117 109 132 111 117.3 10.4 102 75 89 151 104.3 33.0 128 155 102 101 121.5 25.6 100 127 136 93 114.0 20.7 `Statistically significant difference from control mean by analysis of variance and Dunnett's test, p <0.05. SL 082468 TABLE VII1-5 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Clinical Chemistry Values for Male Rats Exposed for 6 Months Animal Number 74-1125 74-1126 74-1127 74-1128 74-1129 Cone. IemI 0 0 0 0 0 Mean +S.D. BUN mg/100ml 17 17 17 19 18 17.6 0.9 SGPT mU/ml 23 29 28 42 34 31 7 Aik. Phos. mU/ml 96 131 97 90 131 109 20 74-1526 74-1527 74-1528 74-1529 74-1530 25 20 25 14 25 31 25 28 25 18 Mean 22.2 +S.D. 7.1 26 24 33 27 23 27 4 90 122 129 161 116 124 26 74-1326 74-1327 74-1328 74-1329 74-1330 75 75 75 75 75 Mean +S.D. 16.0 16.0 16.5 14.5 20.0 16.6 2.0 50 21 28 21 29 30 12 112 131 102 109 117 114 11 No statistically significant difference from control means by analysis of variance and Dunnett's test, p <0.05. TABLE VII1-6 VINV LIDENE CHLORIDE: A CHRONIC! INHALATION TOXICITY AND ONCOGENICITY STUDY IN Clinical Chemistry Values for Female Rats Exposed for 6 Months Animal Number 74-1223 74-1224 74-1225 74-1226 74-1227 74-1623 74-1624 74-1625 74-1626 74-1627 74-1423 74-1424 74-1425 74-1426 74-1427 Cone. (ppm) 0 0 0 0 0 25 25 25 25 25 75 75 75 75 75 Mean +S.D. Mean +S.D. Mean S.D. BUN mg/100ml 26.0 22.0 27.0 30.5 26.0 26.3 3.0 26.0 25.0 26.0 27.0 27.0 26.2 0.8 21.0 21.5 19.5 30.0 19.0 22.2 4.5 SGPT mU/ml 30 30 25 27 27 28 2 23 28 25 28 39 29 6 31 21 16 18 23 22 6 Aik. Phc mU/ml 64 150 112 124 90 108 33 75 70 97 112 239 119 69 75 72 70 83 99 80 12 No statistically significant difference from control mean by analysis of variance and Dunnett's test, p <0.05 SL 082470 TABLE VI11-7 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Clinical Chemistry Values for Male Rats Exposed for 12 Months Animal Number 74-1135 74-1136 74-1137 74-1138 74-1139 74-1533 74-1534 74-1535 74-1536 74-1537 74-1335 74-1336 74-1337 74-1338 74-1339 Cone. (ppm) 0 0 0 0 0 25 25 25 25 25 75 75 75 75 75 Mean +S.D. Mean +S.D. Mean +S.D. BUN mg/100ml 17 20 14 12.5 14 15.5 3.0 21 28 14 17 12.5 18.5 6.2 14.5 14 27 14.5 15 17.0 5.6 SGPT mU/ml 51 39 42 45 45 44.4 4.4 46 52 47 53 39 47.4 5.6 37 39 42 35 49 40.4 5.5 Aik. Phos. mU/ml 74 70 97 91 96 85.6 12.7 64 132 125 121 81 104.6 30.2 98 113 76 121 148 111.2 26.8 Glucose mg/100ml 126 134 136 127 150 134.6 9.6 118 124 116 126 140 124.8 9.4 96 96 no no 102 102.8 7.0* Statistically significant difference from control mean by analysis of variance and Dunnett's test, p <0.05. SL 082471 TABLE VIII-8 VINYLIDENE CHLORIDE: A CHRONIC: INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Clinical Chemistry Values for Female Rats Exposed for 12 Months Animal Number 74-1229 74-1230 74-1231 74-1232 74-1233 74-1633 74-1634 74-1635 74-1636 74-1637 74-1430 74-1431 74-1432 74-1433 74-1434 Cone. (ppm) 0 0 0 0 0 25 25 25 25 25 75 75 75 75 75 Mean +S.D. Mean S.D. Mean S.D. BUN mg/100ml 27 18.5 17 13 14.5 18.0 5.5 12.5 12 10 24 16 14.9 5.5 13 17.5 14 14 14 14.5 1.7 SGPT mU/ml 38 33 47 33 36 37.4 5.8 35 29 39 44 40 37.4 5.7 34 56 33 33 36 38.4 9.9 Aik. Phos. mU/ml 79 47 80 60 87 70.6 16.6 50 81 88 53 56 65.6 17.6 73 97 59 64 93 77.2 17.1 Glucose mq/100ml 134 146 125 131 143 135.8 8.6 136 140 156 127 126 137.0 12.2 126 152 154 123 132 137.4 14.6 No statistically significant difference from control mean by analysis of variance and Dunnett's test, p <0.05 SL 082472 SL 082473 TABLE VI11-9 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Glucose Values for Rats Exposed for 18 Months Animal Number 1 2 3 4 5 MALE Cone. (ppm) 0 0 0 0 0 Mean S.D. Glucose mq/100ml 78 89 88 120 83 92 16 ' Animal Number 1 2 3 4 5 FEMALE Cone. (ppm) 0 0 o' 0 0 Mean +S.D. 11 25 90 12 25 84 13 25 96 14 25 85 15 25 97 Mean +S.D. 90 6 11 25 12 25 13 25 14 25 15 25 Mean +S.D. 6 75 86 7 75 98 8 75 98 9 75 102 10 75 97 Mean 96 +S.D. 6 6 75 7 75 8 75 9 75 10 75 Mean +S.D. H - ~ -L 4- 4 r- 4- 4 1 1 \ j c*inni -Firant difference from control mean using Dunnett's test, p <0.05. Glucose mq/100m 89 103 94 101 113 100 9 102 105 89 79 93 94 10 90 106 98 100 91 97 7 TABLE vril-10 VINYLIDENE CHLORIDE; A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Clinical Chemistry Values Tor Hale Rats Exposed for- 24 Months Animal Number 74-1201 74-1 202 74-1203 74-1204 74-1205 74-1206 74-1208 74-1209 74-1210 74-1213 74-1214 74-1215 74-1216 74-1603 74-1604 74-1605 74-1606 74-1607. 74-1608 74-1609 74-1610 74-1611 74-1612 74-1614 74-1615 74-1616 Cone. (PPm) 0 0 0 0 0 0 0 0 0 0 0 0 0 25 25 25 25 25 25 25 25 25 25 25 25 25 BUN mq/100ml . Mean S.D. 30 24 25 30 28 18 39 16 37 24 44 38 29 29 8 Mean S.D. 21 150 240 36 16 28 43 27 31 33 32 108 16 60 67 SGPT mU/ml 31 37 31 36 28 46 24 32 32 38 27 44 31 34 6 34 29 77 41 52 40 261 49 27 26 29 36 51 58 63 Aik. Phos. mU/ml 102 33 71 113 77 75 82 124 137 102 80 116 55 94 24 81 99 168 55 105 65 79 149 114 115 121 135 86 106 33 74-1407 75 28 31 72 74-1408 75 21 47 85 74-1409 75 26 47 105 74-1410 75 65 50 115 74-1412 75 16 49 100 74-1413 74-1414 74-1415 75 75 75 51 38 110 26 30 95 25 30 112 Mean 32 40 99 5.D. 17 9 15 No statistically significant difference from control mean using Dunnett's test, p <0.05. Glucose mg/100ml 133 90 102 92 97 no 58 109 117 98 122 111 105 103 18 106 148 148 no 86 74 72 107 no 80 85 99 135 105 26 104 89 52 99 96 84 108 no 93 19 SL 082475 APPENDIX IX Individual Animal Data Organ Weights, Fasted Body Weights and Organ to Body Weight Ratios TABLE vn:-n VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Clinical Chemistry Values for Female Rats Exposed Tor 24 Months Animal Number Cone. (ppm) BUN mg/1QCml SGPT mU/ml Aik. Phos. mll/ml 74-1 297 74-1298 74-1299 74-1300 74-1301 74-1302 74-1303 74-1304 74-1306 74-1308 74-1309 74-1310 74-1311 74-1312 74-1313 74-1314 74-1315 74-1316 74-1317 0 22 0 21 0 16 0 12 0 17 0 29 0 22 0 14 0 16 0 30 0 24 0 114 0 19 0 21 0 29 0 114 0 14 09 0 22 Mean 30 S.D. 30 26 63 29 447 52 116 50 169 34 145 33 77 32 75 37 67 25 55 19 82 39 146 40 162 32 82 22 64 51 75 68 267 44 127 25 46 39 92 37 124 12 95 74-1699 74-1700 74-1701 74-1702 74-1703 74-1704 74-1705 74-1706 74-1708 74-1714 74-1716 74-1717 25 19 25 15 25 25 25 18 25 46 25 24 25 19 25 16 25 - 25 31 25 14 25 14 Mean 22 S.D. 10 28 51 33 63 31 89 34 59 53 279 44 219 39 51 41 50 -- 40 64 32 63 32 47 37 94 7 79 74-1498 74-1499 74-1500 74-1501 74-1502 74-1503 74-1504 74-1505 74-1506 74-1507 74-1510 74-1511 74-1512 74-1513 74-1514 74-1515 75 29 75 228 75 20 75 22 75 89 75 17 75 21 75 15 75 15 75 22 75 11 75 20 75 19 75 75 21 11 75 20 Mean 36 5.0. 54 21 45 46 188 42 74 22 70 23 188 40 93 35 98 33 39 32 60 22 192 38 70 25 38 33 143 32 53 40 53 25 60 32 92 8 55 No statistically significant difference from control mean using Dunnett's test, p <0.05. Glucose mq/100ml 114 72 74 no 118 92 99 92 134 83 100 112 104 84 141 45 128 109 106 101 23 111 104 no 88 20 89 98 60 - 76 122 103 89 29 131 81 131 122 109 98 70 102 84 90 91 73 84 77 80 90 95 20 SL 082474 TABLE IX-i VIHYLIDENE CHLORIDE: A CHROMIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Organ and Body Height Values for Hale Rats Exposed for 1 Honth Animal Humber 74-1119 74-1120 74-1121 74-1122 74-1521 74-1522 74-1523 74-1524 74-1319 74-1320 74-1321 74-1322 Dose Ppm Body Heiqht 0 0 0 0 Mean S.D. 360 389 391 354 373 19 10 10 10 10 Mean >S.D. 398 426 378 345 387 34 40 40 40 40 Mean S.D. 402 401 425 403 408 12 Brain 9 q/lOOq 1.765 1.834 1.975 1.689 1.82 0.12 0.490 0.472 0.505 0.477 0.49 0.01 1.826 1.873 1.861 1.809 1.84 0.03 0.459 0.440 0.492 0.524 0.48 0.04 1.887 1.798 1.851 1.876 1.85 0.04 0.469 0.448 0.436 0.466 0.45 0.02 Heart 9 q/lOOq 1.021 1.264 1.395 1.117 1.20 0.16 0.284 0.325 0.357 0.316 0.321 0.03 1.170 1.169 1.106 1.061 1.13 0.05 0.294 0.274 0.293 0.308 0.292 0.01 1.206 1.151 1.488 1.188 1.26 0.15 0.300 0.287 0.350 0.295 0.308 0.03 Liver 9 q/lOOq 10.610 10.931 11.945 11.124 11.15 0.57 2.947 2.810 3.055 3.142 2.989 0.14 12.053 12.723 11.255 9.010 11.26 1.62 3.028 2.987 2.978 2.612 2.901 0.91 11.699 11.938 13.051 12.678 12.34 0.63 2.910 2.978 3.071 3.146 3.026 0.10 Kidney 9 q/lOOq 2.485 2.800 2.828 2.708 2.71 0.16 0.690 0.720 0.723 0.765 0.725 0.03 3.058 2.823 2.806 2.367 2.76 0.29 0.768 0.663 0.742 0.686 0.715 0.05 2.927 3.075 2.785 2.926 2.93 0.12 0.728 0.767 0.655 0.726 0.719 0.05 Testes 9 q/lOOq 3.816 3.852 3.767 3.268 3.68 0.27 1.060 0.990 0.963 0.923 0.984 0.06 3.690 4.106 3.754 3.527 3.76 0.24 0.927 0.964 0.993 1.022 0.977 0.04 3.664 3.523 3.727 3.297 3.55 0.19 0.911 0.B79 0.877 0.818 0.871* 0.04 `Statistically significant difference from control mean using Dunnett's test, p <0.05. SL 082477 TABLE IX-2 VINYLI0ENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Organ and Body Height Values for Female Rats Exposed for 1 Month Number 74-1218 74-1210 74-1220 74-1221 fiPJ1.. Body Height 0 0 0 0 Mean iS.D. 279 234 240 249 251 20 74-1618 74-1619 74-1620 74-1621 10 10 10 10 Mean iS.D. 252 250 244 250 249 3 74-1418 74-1419 74-1420 74-1421 40 40 40 40 *S.D. 244 210 259 231 236 21 Brain q/lOOg 1.76 1.73 1.79 1.65 1,73 0.06 0.631 0.738 0.745 0.661 0.69 0.06 1.78 1.70 1.77 1.75 1.75 0.04 0.708 0.680 0.725 0.699 0.70 0.02 1.74 1.67 1.78 1.76 1 .74 0.05 0.712 0.795 0.686 0.763 0.074 0.05 Heart -__9___ q/100q 0.83 0.78 0.82 0.80 0.81 0.02 0.296 0.331 0.342 0.322 0.323 0.02 0.81 0.77 0.80 0.93 0.83 0.07 0.321 0.309 0.328 0.372 0.33 0.03 0.77 0.66 0.84 0.75 0.75 0.07 0.315 0.313 0.323 0.323 0.32 0.01 Liver _JI q/lOOq 6.92 6.16 6.42 6.32 6.45 0.33 2.480 2.633 2.673 2.540 2.58 0.09 6.21 6.51 6.31 6.90 6.48 0.30 2.464 2.604 2.586 2.759 2.60 0.12 5.92 5.53 6.50 5.54 5.87 0.45 2.425 2.635 2.506 2.398 2.49 0.11 No statis tically significant difference from control mean using Dunnett's test, p <0 .05. tCidnev q g/Toog 1.92 1.42 t .81 1.6/ 1.70 0.22 0.690 O.bOti 0.753 0-669 0.68 0.06 1.95 t. /b 1.87 1.87 1.86 0.08 0.775 0.700 U. /bb 0.748 U. /b 0.02 1.73 1.49 1.88 1 . tlJ !. 68 0.16 0.707 0.711 0.724 0.704 0.71 0.01 SL 082478 TABLE 1X-3 VINYL10ENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Organ and Body Weight Values for Hale Rats Exposed for 6 Months Animal Number 74-1125 74-1126 74-1127 74-1128 74-1129 74-1526 74-1527 74-1528 74-1529 74-1530 74-1326 74-1327 74-1326 74-1329 74-1330 Etose PPm Body Weiqht 0 0 0 0 0 Mean tS.D. 532 524 531 625 555 553 417 25 25 25 25 25 Mean S.D. 534 557 480 508 529 522 29.1 75 75 75 75 75 Mean S.D. 523 593 518 460 504 520 48.0 Brain 9 q/lOOg 1.844 1.950 1.899 1.716 1.761 1.83 0.10 0.3466 0.3721 0.3576 0.2746 0.3173 0.33 0.04 2.044 1.837 1.949 1.921 1.970 1.94 0.08 0.3828 0.3298 0.4060 0.3781 0.3724 0.37 0.03 1.975 2.013 1.934 2.002 1.891 1.96 0.05 0.3776 0.3395 0.3734 0.4352 0.3752 0.38 0.03 Heart 9 q/100q 1.512 1.574 1.435 1.725 1.359 1.52 0.14 0.2842 0.3004 0.2702 0.2760 0.2449 0.28 0.02 1.276 1.426 1.328 1.564 1.401 1.40 0.11 0.2390 0.2560 0.2767 0.3079 0.2643 0.2689 0.03 1.576 1.582 1.498 1.379 1.425 1.49 0.09 0.3013 0.2668 0.2892 0.2998 0.2827 0.29 0.01 Liver 9 g/lOOg 14.834 12.445 12.573 21.200* 15.022 2.7883 2.3750 2.3687 3.3920 2.7067 2.73 0.42 14.573 16.544 11.582 13.194 13.155 2.7290 2.9702 2.4129 2.5972 2.4868 2.64 0.22 13.830 15.031 12.434 10.828 14.019 2.6444 2.5347 2.4004 2.3539 2.7815 2.54 0.18 Kidney 9 q/lOOq 3.964 3.429 3.223 4.535 3.688 3.77 0.51 0.7451 0.6544 0.6070 0.7256 0.6645 0.68 0.06 3.297 4.016 3.274 3.977 3.606 3.63 0.36 0.6174 0.7210 0.6821 0.7829 0.6817 0.70 0.06 3.568 4.417 3.019 3.322 3.542 3.57 0.52 0.6822 0.7449 0.5828 0.7222 0.7028 0.69 0.06 Testes 9 g/TOOq 4.216 3.988 3.839 3.402 3.939 3.88 0.30 0.7925 0.7611 0.7230 0.5443 0.7097 0.71 0.10 3.766 3.804 3.780 3.958 3.957 3.85 0.10 0.7052 0.6829 0.7875 0.7791 0.7480 0.74 0.05 4.38B 4.106 3.638 3.976 3.440 3.90 0.36 0.8306 0.6924 0.7023 0.8643 0.6825 0.75 0.09 *Due to this outlier, mean and standard deviation were not calculated. No statistically significant difference from control mean by Dunnett's test, p <0.05. SL 082479 TABLE IX-4 VINYLIOENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Organ and Body Weight Values for Female Rats Exposed for 6 Months Animal Number Dose ppm Body Weight 74-1223 74-1224 74-1225 74-1226 74-1227 0 0 0 0 0 Mean `S.O. 323 336 305 328 343 327 14.5 74-1623 74-1624 74-1625 74-1626 74-1627 25 25 25 25 25 Mean JS.D. 325 363 283 315 230 303 49.9 74-1423 74-1424 74-1425 74-1426 74-1427 75 75 75 75 75 Mean *5.0. 342 329 333 297 332 327 17.2 Brain q g/lOOq 1.839 1.803 1.812 1.770 1.825 1.81 0.03 0.5693 0.5366 0.5941 0.5396 0.5321 0.55 0.03 1.648 1.848 1.831 1.736 1.777 1.81 0.05 0.5686 0.5091 0.6470 0.5511 0.7726 0.61 0.10 1.761 1.798 1.833 1.862 1.905 1.83 0.06 0.5149 0.5465 0.5505 0.6269 0.5738 0.56 0.04 Heart 9 q/lOOq 0.976 1.024 0.901 1.061 0.918 0.98 0.07 0.3022 0.3048 0.2954 0.3235 0.2676 0.30 0.02 1.022 1.077 0.893 0.964 0.665 0.92 0.16 0.3145 0.2967 0.3155 0.306 0.2891 0.30 0.01 0.980 0.991 0.983 0.891 0.928 0.95 0.04 0.2865 0.3012 0.2952 0.3000 0.2795 0.29 0.01 Liver . 9 _ q/lOOg 7.546 8.865 6.645 7.440 5.769 7.25 1.15 2.3362 2.6384 2.1787 2.2683 1.6819 2.22 0.35 6.897 9.065 6.174 6.754 5.804 6.94 1.27 2.1222 2.4972 2.1816 2.1441 2.5235 2.29 0.20 8.22 7.225 7.490 6.318 8.115 7.47 0.77 2.4035 2.1960 2.2490 2.1273 2.443 2.2B 0.14 Kidney __ a___ aZJQOa 2.049 2.327 1.937 2.237 1.603 2.03 0.28 0.6344 0.6926 thfcjbl 0.6820 0.4673 0.62 0.09 1.955 2.119 1.986 2.010 1.334 1.88 0.31 0.6015 0.5837 0.7018 0.6381 0.5800 0.62 0.05 1.860 2.042 2.162 1.919 2.231 2.04 0.16 0.5439 0.6207 0.6492 0.6461 0.6720 0.63 0.05 No statistically significant difference from control mean by Ounnett's itest, p <0.05. Co tr> O 08b?8 TABLE 1X-5 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Organ and Body Height Values for Hale Rats Exposed for 12 Months Animal Numbe r 74-1135 74-1136 74-1137 74-1138 74-1139 74-1533 74-1534 74-1535 74-1536 74-1537 74-1335 74-1336 74-1337 74-1338 74-1339 Dose PPm Body Height 0 0 0 0 0 Mean *S.D. 612 615 699 673 703 660.4 44.3 25 25 25 25 25 Mean S.D. 565 615 626 505 564 575* 48.3 75 75 75 75 75 Mean *S.D. 614 593 553 509 545 562.8* 41.4 Brain 9 ItfTOOq 1.90 1.89 2.07 2.02 2.04 1.98 .08 .31 .31 .30 .30 .29 .30 .01 2.02 1.88 1.91 2.07 1.99 1.97 .08 .36 .31 .31 .41 .35 .35 .04 1.93 1.89 1.94 1.94 1.96 1 .93 .03 .31 .32 .35 .38 .36 .34 .03 Heart 9 q/lOOq 1.57 1.57 1.57 1.84 1.87 1.68 .16 .26 .26 .23 .27 .27 .26 .02 1.54 1.58 1.64 1.54 1.60 1.58 .04 .27 .26 .26 .30 .28 .28 .02 1.57 1.70 1.49 1.54 1 .42 1.54 .11 .26 .29 .27 .30 .26 .27 .02 Liver 9 q/lOOq 20.32 22.03 19.56 18.75 22.17 20.57 1.51 3.32 3.58 2.80 2.79 3.15 3.13 .34 16.84 16.71 16.80 12.42 13.66 15.28* 2.10 2.98 2.72 2.68 2.46 2.42 2.65* .23 15.78 16.10 17.39 12.06 14.24 15.13* 2.06 2.57 2.73 3.15 2.37 2.61 2.69 .29 Kidney 9 q/lOOq 4.42 5.25 3.95 4.23 4.13 4.39 .51 .72 .85 .56 .63 .59 .67 .12 4.45 4.18 3.97 3.52 3.60 3.94 .39 .79 .68 .63 .70 .64 .69 .06 3.99 4.05 4.83 3.41 3.90 4.04 .51 .65 .68 .87 .67 .72 .72 .09 Statistically significant difference from control mean by Dunnett's test, p <0.05. Testes 9 qTTOOq 3.67 3.92 4.35 4.38 4.09 4.08 .30 .60 .64 .62 .65 .58 .62 .03 3.94 3.82 4.12 4.40 3.89 4.04 .23 .70 .62 .66 .87 .69 .71 .10 3.75 3.79 3.70 4.02 4.14 3.88 .19 .61 .64 .67 .79 .76 .69 .08 SL 082481 TABLE 1X-G VINYLIDENE CHLORIDE; A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Organ and Body Height Values for Female Rats Exposed for 12 Months Animal Number 74-1229 74-1230 74-1231 74-1232 74-1233 Dose ppm Body Weight 0 0 0 0 0 Mean S.D. 326 360 313 330 316 329 18.7 Brain g/lOOq 1.90 1.77 1.B1 1.75 1.86 1.82 .06 .58 .49 .58 .53 .59 .55 01 Heart 9 q/IDOq .95 1.15 .95 1.10 1.01 1.03 .09 .29 .32 .30 .33 .32 .31 .02 Liver q 9/1009 7.29 8.41 7.06 7.84 6.63 7.45 .69 2.24 2.34 2.25 2.38 2.10 2.26 .11 74-1633 74-1634 74-1635 74-1636 74-1637 25 25 25 25 25 Mean <S.O. 394 344 374 383 333 365.6 26.0 1.85 1.91 1.86 1.78 1.68 1.82 .09 .47 1.19 .55 1.07 .50 .96 .46 1.03 .50 1.22 .50 1.09 .04 .11 .30 8.21 2.08 .31 7.06 2.05 .26 7.72 2.06 .27 8.01 2.09 .37 10.97 3.29 .30 8.39 2.32 .04 1.51 .55 74-1430 74-1431 74-1432 74-1433 74-1434 75 75 75 75 75 Mean S.D, 312 396 362 307 321 339.6 38.3 1.77 1.85 1.67 1.78 1.77 1.77 .06 .57 1.06 .47 1.10 .46 1.08 .58 1.07 .55 1.07 .53 I.OB .06 .01 .34 9.40 3.01 .28 10.16 2.57 .30 8.88 2.45 .35 7.98 2.60 .33 8.79 2.74 .32 9.04 2.67 ,03 .80 .21 `Statistically significant difference from control mean by Dunnett's test, p <0.05. Kidney ___ 9. g/1OOq 2.10 2.10 2.03 2.23 1.97 2.09 .10 .64 .58 .65 .67 .62 .63 .03 2.38 2.28 2.38 2.27 2.91 2.44* .26 .61 .66 .64 .59 .87 .67 .11 2.51 2.68 2.66 2.82 2.35 2.60* .18 .80 .68 .73 .92 .73 .77 .09 SL 082482 TABLE IX-7 VINYLiDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Organ and Body Height Values for Male Rats Exposed for 24 Months An inia 1 Number Dose )>]"" Body Weight Brain q g/lOOq Heart 9 g/100q Liver 9 g/lOOq Kidney 9 q/lOOq Testes 9 q/1OOq 74-1201 74-1202 74-1203 74-1204 74-1205 74-1206 74-1208 74-1209 74-1210 74-1213 74-1214 74-1215 74-1216 0 0 0 0 0 0 0 0 0 0 0 0 0 Mean S.D. 474 382 514 526 685 580 494 554 478 633 570 498 466 527 78 2.00 2.08 1.99 2.03 1.80 2.04 1.90 1.96 1 .92 1.8B 2.02 1.70 1.87 1.94 0.11 0.42 0.55 0.39 0.38 0.26 0.35 0.38 0.35 0.40 0.30 0.35 0.34 0.40 0.38 0.07 1.84 1.47 2.02 1.86 1.84 1.90 1.84 1.61 1.86 1.99 2.08 2.04 2.11 1.88 0.18 0.39 0.39 0.39 0.35 0.27 0.33 0.37 0.29 0.39 0.31 0.36 0.41 0.45 0.36 0.05 16.17 13.95 18.34 16.98 20.16 18.73 18.42 16.40 19.50 20.63 20.68 18.98 18.76 18.28 1.95 3.41 3.65 3.57 3.23 2.94 3.23 3.73 2.96 4.08 3.26 3.63 3.81 4.03 3.50 0.37 3.87 6.57 6.11 4.49 5.28 5.29 6.13 4.50 7.22 6.54 7.36 6.34 6.33 5.85 1.08 0.82 1.72 1.19 0.85 0.77 0.91 1.24 0.81 1.51 1.03 1.29 1.27 1.36 1.14 0.30 3.76 3.98 4.41 4.59 3.96 5.52 2.64 4.82 3.51 a 4.66 5.23 3.53 4.22 0.83 0.79 1.04 0.86 0.87 0.58 0.95 0.54 0.87 0.74 a 0.82 1.05 0.76 0.82 0.16 74-1603 74-1604 74-1605 74-1606 74-1607 74-1608 74-1609 74-1610 74-1611 74-1612 74-1614 74-1615 74-1616 25 25 25 25 25 25 25 25 25 25 25 25 25 Mean S.D. 586 420 393 529 598 508 364 376 622 526 535 500 484 495 85 2.07 1.98 2.09 2.21 2.11 1.96 1.86 1.98 1.90 2.02 1 .88 1.84 1.92 1.99 0.11 0.35 0.47 0.53 0.42 0.35 0.39 0.51 0.53 0.31 0.38 0.35 0.37 0.40 0.41 0.07 2.00 2.34 1.96 1.62 1.72 1.75 1.37 1.62 2.11 2.16 2.01 2.24 1.50 1.88 0.30 0.34 0.56 0.50 0.31 0.29 0.34 0.38 0.43 0.34 0.41 0.38 0.45 0.31 0.39 0.08 19.98 18.19 14.28 16.89 15.62 15.08 12.84 12.32 22.77 18.97 17.91 18.71 16.41 16.92 2.94 3.41 4.33 3.63 3.19 2.61 2.97 3.53 3.28 3.66 3.61 3.35 3.74 3.39 3.44 0.41 4.40 6.85 5.59 5.21 4.95 4.63 4.06 4.20 6.40 6.16 5.85 6.36 4.63 5.33 0.93 0.75 1.63 1.42 0.99 0.83 0.91 1.12 1.12 1.03 1.17 1.09 1.27 0.96 1.10 0.24 3.08 2.22 3.25 4.12 4.12 3.84 2.74 3.70 4.10 4.14 2.75 3.91 4.30 3.56 0.68 0.53 0.53 0.83 0.78 0.69 0.76 0.75 0.98 0.66 0.79 0.51 0.78 0.89 0.73 0.14 74-1407 74-1408 74-1409 74-1410 74-1412 74-1413 74-1414 74-1415 75 75 75 75 75 75 75 75 Mean S.D. 552 374 441 476 511 494 533 551 492 61 2.00 1.92 1.95 1.96 2.04 1.88 2.04 2.00 1 .97 0.06 0.36 0.51 0.44 0.41 0.40 0.38 0.38 0.36 0.41 0.05 1.95 1.59 1.59 1.78 1.75 1.96 1.98 2.14 1.84 0.20 0.35 0.42 0.36 0.37 0.34 0.40 0.37 0.39 0.38 0.03 18.52 11.59 15.86 18.49 17.38 15.98 18.05 19.81 16.96 2.54 3.35 3.10 3.60 3.88 3.40 3.24 3.39 3.59 3.44 0.24 5.43 3.88 5.91 6.52 5.36 5.00 5.91 5.29 5.41 0.78 0.98 1.04 1.34 1.37 1.05 1.01 1.11 0.96 1.11 0.16 4.34 3.74 3.92 3.48 4.84 4.10 4.61 4.13 4.14 0.45 0.79 1.00 0.89 0.73 0.95 0.83 0.86 0.75 0.85 0.09 No statistically significant difference from control mean using Dunnett's test, p <0.05. aTe$tes retained ini abdominal cavity and were hypoplastic. They were not included in data analysis. CO tr> 8>8o TABLE IX-0 VI NYU DENE CHLORIDE: A CHRONIC :vHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Organ and Body Lei got 7a lues for Female Rats Exposed for 24 Months Animal Number Oose ppm Sody Weiaht 74-1297 74-1298 74-1299 74-1300 74-1301 74-13 02 74-1303 74-1304 74-1 306 74-1308 74-1309 74-1310 74-1311 74-1312 74-1313 74-1314 74-1315 74-1316 74-1317 74-1217 74-1516 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Mean S.D. 427 381 424 329 330 444 32S 416 454 399 359 234 478 551 629 536 299 391 293 420 323 402 95 74-1700 74-1701 74-1702 74-1703 74-1704 74-1705 74-1706 74-1714 74-1716 74-1717 74-1617 74-1517 74-1699 25 25 25 25 25 25 25 25 25 25 25 25 25 Mean :S.D. 371 426 419 431 406 334 390 377 308 307 599 685 385 418 109 74-1498 74-1499 74-1500 74-1501 74-1502 74-1503 74-1504 74-1505 74-1506 74-1507 74-1510 74-1511 74-1512 74-1513 74-1514 74-1515 75 75 75 75 75 75 75 75 75 75 75 75 7S 75 75 75 Mean *5.0. 448 337 391 496 276 377 495 424 335 417 323 523 400 492 397 340 404 72 Bra i n q q/ 1 OGr) 1.89 1 .83 1 .72 1.75 1 .84 1.78 1.77 1.86 1.88 1.83 1.69 1.74 1.80 1 .86 1.75 1.73 1 .82 1.71 1 .75 1 .81 1.82 1.79 0.06 0.44 0.48 0.41 0.53 0.56 0.40 0.54 0.45 0.41 0.46 0.47 0.74 0.38 0.34 0.28 0.32 0.61 0.44 0.60 0.43 0.56 0.47 0.11 1.75 1 .69 1.79 1 .83 1.69 1 .78 1.79 1 .68 1.83 1.82 1.85 1.83 1.75 1 .77 0.06 0.47 0.40 0.43 0.42 0.42 0.53 0.46 0.45 0.59 0.59 0.31 0.27 0.45 0.45 0.09 1.80 1 .71 1.70 1 .75 1.74 1.74 1.73 1.74 1.66 1.92 1.74 1.67 1.78 1.81 1.84 1.78 1.76 0.07 0.40 0.51 0.43 0.35 0.63 0.46 0.35 0.41 0.50 0.46 0.54 0.32 0.44 0.37 0.46 0.52 0.45 0.08 Heart 9 g/lOOq 1.23 1.34 1.12 0.93 1.23 1.17 1.21 1 .44 1.11 1.29 1.29 1.35 1.54 1 .41 1.11 1 .13 1.10 1.09 1.29. 1 .44 1.21 1.24 0.15 0.29 0.35 0.26 0.28 0.37 0.26 0.37 0.35 0.25 0.32 0.36 0.58 0.32 0.26 0.18 0.21 0.37 0.28 0.44 0.34 0.37 0.32 0.09 1.80 1.10 1.43 1.14 1.07 1.41 1.15 1.50 1.29 1.19 1.21 1.29 1.19 1.29 0.20 0.49 0.26 0.34 0.26 0.26 0.42 0.29 0.40 0.42 0.39 0.20 0.19 0.31 0.33 0.09 1.59 1.19 1.33 1 .23 1.42 1.38 1.24 1 .34 1.22 1 .46 1.11 1.12 1.20 1.06 1.04 1.36 1.27 0.15 0.35 0.35 0.34 0.25 0.52 0.36 0.25 0.32 0.36 0.35 0.34 0.21 0.30 0.22 0.26 0.40 0.32 0.08 Liver q 'g/lOOq 17.58 11.97 10.86 10.05 8.41 20.09 12.16 10.37 16.08 14.17 14.46 9.65 18.72 17.93 18.96 9.94 8.08 15.43 10.36 19.93 7.74 13.47 4.17 4.12 3.14 2.56 3.05 2.55 4.52 3.71 2.49 3.54 3.55 4.03 4.12 3.92 3.25 3.01 1.85 2.70 3.95 3.54 4.75 2.40 3.37 0.76 11.08 17.32 13.12 12.17 12.42 12.05 10.67 16.81 8.63 10.54 18.20 21.81 11.86 13.59 3.77 2.99 4.07 3.13 2-82 3.06 3.61 2.73 4.46 2.80 3.43 3.04 3.18 3.08 3.26 0.51 Kidnev q q/lOOq 3.38 2.56 2.88 2.39 2.72 3.09 2.80 2.94 2.68 2.64 3.78 3.46 3.62 2.80 2.38 2.31 2.67 3.59 2.68 3.90 2.37 2.94 0.49 0.79 0.67 0.68 0.73 0.83 0.70 0.85 0.71 0.59 0.66 1.05 1.48 0.76 0.51 0.38 0.43 0.89 0.92 0.92 0.93 0.73 0.77 0.23 2.74 2.63 2.77 2.74 2.31 3.85 2.81 4.70 2.47 2.88 2.66 3.08 2.89 2.96 0.63 0.74 0.62 0.66 0.64 0.57 1.15 0.72 1.25 0.80 0.94 0.44 0.45 0.75 0.75 0.24 23.31 9.10 12.43 15.38 12.75 11.52 12.80 21.36 10.51 16.97 8.65 15.97 10.06 19.05 9.97 14.03 13.99 4.39 5.20 2,70 3.18 3.10 4.62 3.06 2.59 5.04 3.14 4.07 2.68 3.05 2.51 3.37 2.51 4.13 3.47 0.90 4.10 2.66 2.88 2.68 4.48 2.99 2.75 3.29 2.66 3.53 2.64 3.06 2.96 2.53 2.90 3.42 3.10 0.55 0.92 0.79 0.74 0.54 1.62 0.79 0.56 0.77 0.79 0.85 0.82 0.58 0.74 0.52 0.73 1.01 0.80 0.26 No statistically s ignificant difference from control mean using Dunnett 's test, p <0 .05. 0S2489 Sli APPENDIX X GROSS AND HISTOPATHOLOGY DATA UNIDENTIFIED ANIMALS SL 082484 TABLE VINYLIDENE CHLORIDE: A CHRONIC INHALATIu,. TOXICITY AND ONCOGENICITY STUDY IN RATS Gross Pathologic Observations of Nontumors for Unidentified Male Rats Number of rats autopsied during 19-24 mo. interval _1_____________________ Cumulative Results GENERAL Malocclusion A-09 Abscess of molar teeth with inf lamination of surrounding tissues A-19 1 1 ADIPOSE TISSUE Depleted or any decrease inquantity D-01 1 REPRODUCTIVE SYSTEM Testicular atrophy (flaccid) - unilateral and bilateral (decreased in size) IE-2 1 LYMPHORETICULAR SYSTEM Lymph Node(s) - swollen and/or congested, edematous - local, containing hematogenous pigment or cystic G-01 1 KIDNEY Chronic renal disease with or without cyst formation L " minimal I2-L 1 SL 082488 TABLE X-2 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Nontumors in Unidentified Male Rats Number of rata autopsied during 19-24 mo. interval ____________1_ Cumulative Results LIVER Generalized hepatic lobular atrophy H-02 1 RESPIRATORY SYSTEM Lungs Focal alveolar histiocytosis R-22 Peribronchial lymphoid cellular infiltrate R~23 1 1 URINARY SYSTEM Kidney Minimal degree of chronic nephropathy U-01 1 ADIPOSE TISSUE Mediastinal or renal fatatrophy B-01 1 CARDIOVASCULAR SYSTEM Heart Minimal degree of focal myocardial degeneration and fibrosis C-01 1 MUSCULOSKELETAL SYSTEM Atrophy of skeletal muscle with or without mineraliza tion M-01 LYMPHORETICULAR SYSTEM Mesenteric Lymph Nodes Lymphoid hyperplasia L-35 Spleen Atrophy of spleen with or without hemosiderin pigment L-38 1 1 1 SL 082485 TABLE X-2 (continued) VINYUDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Nontumors in Unidentified Male Rats Number of rats autopsied during 19-24 mo. interval ____________1 Cumulative Results GASTROINTESTINAL SYSTEM Stomach Focal erosion of gastric mucosa G-05 Cecum Acute suppurative inflamination with squamous metaplasia of the ducts with keratinization of the lining epithelium G-73 REPRODUCTIVE SYSTEM Testes Testicular atrophy X-02 ADRENAL GLAND Cortex Focus of lipomatosis A-27 082487 TABLE X-3 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Number of Unidentified Male Rats for Which the Specified Tissue was Examined Microscopically Number of rats autopsied during 19-24 mo. interval 1 Cumulative Results Liver Heart Kidney Lungs Pancreas Spleen Skeletal Muscle Mediastinal Fat Salivary Gland Esophagus Trachea Parathyroid Thyroid Stomach Small Intestine Urinary Bladder Testes Epididymis Peripheral Nerve Spinal Cord Adrenal Gland Cerebellum Cerebral Cortex Mediastinal Lymphoid Tissue 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 SL 082486 TABLE X-4 VINVLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Gross Pathologic Observations of Nontumors for Unidentified Female Rats Number of rats autopsied at terminal kill____________ ____________ A Cumulative Results GENERAL External ulcerated lesion A-12 INTEGUMENTARY SYSTEM AND TONGUE Mammary gland hyperplasia B-05 REPRODUCTIVE SYSTEM Ovary - cyst 2E-2 Uterus - hyperplasia with or without cysts 2E-14 1 1 1 1 LIVER Enlarged or congested with or without secondary darkening H-01 Small white foci (also pale) H-03 Red subcapsular foci H-04 Accentuation of lobular pattern H-ll 1 1 1 1 KIDNEY Chronic renal disease with or without cyst formation - moderate I2-M 1 ADRENAL GLAND Mottled appearance J-05 RESPIRATORY SYSTEM Small pale subpleural foci K-15 A 2 NERVOUS SYSTEM Pituitary - red foci with focal enlargement N-09 1 SL 082490 TABLE X-5 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Nontumors in Unidentified Female Rats Number of rats autopsied at terminal kill 4 Cumulative Results LIVER Foci of eosinophilic ground-glass appearing cells H-01 Area of eosinophilic ground-glass appearing cells H-02 Foci of mononuclear cells within the portal area or lobule H-10 Atrophy without fatty change H-12 Focal necrosis H-14 Extramedullary hematopoiesis H-31 Sinusoidal vascular dilatation H-35 Centrilobular atrophy H-40 1 1 3 1 1 3 2 2 RESPIRATORY SYSTEM Lungs Focal peribronchiolar mononuclear cell infil trate R-22 Focal areas of alveolar histiocytosis R-23 4 4 URINARY SYSTEM Kidney Chronic focal progressive nephrosis - minimal U-01 Chronic focal progressive nephrosis - severe U-03 Mineralized deposits in kidney U-08 3 1 1 CARDIOVASCULAR SYSTEM Heart Focal myocardial degeneration and fibrosis minimal C-01 2 Blood Vessels Periarteritis and sclerosis of mesenteric blood vessels and other selected blood vessels C-41 1 SI 08249l TABLE X-5 (continued) VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Nontumors in Unidentified Female Rats Number of rats autopsied at terminal kill 4 Cumulative Results NERVOUS SYSTEM Spinal Cord Vacuolization of spinal cord N-18 2 Peripheral Nerves Vacuolization of myelin within peripheral nerves N-32 2 LYMPHORETICULAR SYSTEM Spleen Increased extramedullary hematopoiesis in spleen L-40 3 GASTROINTESTINAL SYSTEM Large Intestine Intestinal nematodiasis G-50 1 Pancreas Focal atrophy of pancreatic acinar tissue P-03 Focal interstitial pancreatitis P-05 1 1 ADRENAL GLAND Hematocyst formation within adrenals Hyperplastic focus of adrenal cortex A-02 A-24 3 2 SUBCUTANEOUS TISSUES, MAMMARY GLAND, AND INTEGUMENT Integument Chronic granulation tissue with ulceration and necrosis of the rear limb S-55 1 THYROID AND PARATHYROID Hyperplastic focus of thyroid T-05 2 SL 082492 TABLE X-6 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Gross Pathologic Observations of Tumors or Tumor-Like Lesions in Unidentified Female Rats Number of rats autopsied at terminal kill 4 Cumulative Results INTEGUMENTARY SYSTEM AND TONGUE Subcutaneous tumor - mammary and midcervical region B-Q2-( ) Number per rat* (3) Number per rat= (4) Number per rat* (5) 1 1 1 REPRODUCTIVE SYSTEM Uterus - endometrial polyp 2E-05 1 LYMPHORETICULAR SYSTEM Local invasion of tumor with regional lymph node(s) involved G-04 1 NERVOUS SYSTEM Pituitary gland - increased in size or irregular in shape - with or without associated generalized color and consistency changes N-02 2 THYROID AND PARATHYROID Thyroid gland - increased in size 0-01 1 SIj 082493 TABLE X-7 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Histopathologic Diagnosis and Number of Tumors or Tumor-Like Lesions in Unidentified Female Rats Number of rats autopsied at terminal kill ______ 4 Cumulative Results NERVOUS SYSTEM Pituitary Pituitary adenoma N-44 2 REPRODUCTIVE SYSTEM Uterus Endometrial polyp formation X-77 2 ADRENAL GLAND Medulla Adrenal pheochromoeytoma, unilateral A-47 1 SUBCUTANEOUS TISSUES. MAMMARY GLAND, AND INTEGUMENT Subcutaneous fibrosarcoma without metastasis S-05 Mammary gland fibroadenoma/adenofibroma S-25 1. 11/3 ^Number of tumors/number of animals with tumors. SL 082494 TABLE X-8 VINYLIDENE CHLORIDE: A CHRONIC INHALATION TOXICITY AND ONCOGENICITY STUDY IN RATS Number of Unidentified Female Rats for Which the Specified Tissue was Examined Microscopically Number of rats autopsied at terminal kill Liver Heart Kidney Lung Pancreas Spleen Skeletal Muscle Mediastinal or Perirenal Fat Salivary Gland Aorta Esophagus Trachea Parathyroid Thyroid Stomach Small Intestine Large Intestine Mesenteric Lymph Nodes Mesenteric Vessels Urinary Bladder Ovaries Oviducts Uterus Peripheral Nerve Spinal Cord Pituitary Gland Adrenal Glands Cerebellum Cerebral Cortex Eyes Skin Mediastinal Lymphoid Tissue _________ ______________ Cumulative Results A A A A 2 A 3 2 2 2 3 A 1 A 1 2 2 2 2 3 3 3 3 2 2 A A A A A 1 2 SL 082495