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Ethylene Thiourea (CASRN 96-45-7) in F344 Rats and B6c3f1mice

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Ethylene Thiourea (CASRN 96-45-7) in F344 Rats and B6c3f1mice NATIONAL TOXICOLOGY PROGRAM Technical Report Series No. 388 /*""•*'* TOXICOLOGY AND CARCINOGENESIS STUDIES OF ETHYLENE THIOUREA (CAS NO. 96-45-7) IN F344/N RATS AND B6C3F! MICE (FEED STUDIES) U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health FOREWORD The National Toxicology Program (NTP) is made up of four charter agencies of the U.S. Department of Health and Human Services (DHHS): the National Cancer Institute (NCI), National Institutes of Health; the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health; the National Center for Toxicological Research (NCI'R), Food and Drug Administration; and the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control. In July 1981, the Carcinogenesis Bioassay Testing Program, NCI, was transferred to the NIEHS. The NTP coordinates the relevant programs, staff, and resources from these Public Health Service agencies relating to basic and applied research and to biological assay development and validation. The NTP develops, evaluates, and disseminates scientific information about potentially toxic and hazardous chemicals. This knowledge is used for protecting the health of the American people and for the primary prevention of disease. The studies described in this Technical Report were performed under the direction of the NIEHS and were conducted in compliance with NTP laboratory health and safety requirements and must meet or exceed all applicable federal, state, and local health and safety regulations. Animal care and use were in accordance with the Public Health Service Policy on Humane Care and Use of Animals. All aspects of the chronic studies were subjected to retrospective quality assurance audits before being presented for public review. These studies are designed and conducted to characterize and evaluate the toxicologic potential, including carcinogenic activity, of selected chemicals in laboratory animals (usually two species, rats and mice). Chemicals selected for NTP toxicology and carcinogenesis studies are chosen primarily on the bases of human exposure, level of production, and chemical structure. Selection per se is not an indicator of a chemical's carcinogenic potential. These NTP Technical Reports are available for sale from the National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161 (703-487-4650). Single copies of this Technical Report are available without charge while supplies last from the NTP Central Data Management, NIEHS, P.O. Box 12233, MD Ao-01, Research Triangle Park, NC 27709 (919-541-1371). NTP TECHNICAL REPORT ON THE PERINATAL TOXICOLOGY AND CARCINOGENESIS STUDIES OF ETHYLENE THIOUREA (CAS NO. 96-45-7) IN F344/N RATS AND B6C3F1 MICE (FEED STUDIES) L NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 March 1992 NTP TR 388 NIH Publication No. 92-2843 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health 2 Ethylene Thiourea, NTP TR 388 CONTRIBUTORS National Toxicology Program NTP Pathology Working Group Evaluated and intepreted results and reported fidinp Evaiuated slides, prepared pathology repon for r& (25 August 1988) C.J. Alden, Ph.D. G.A. Boorman, D.V.M., Ph.D. P.K Hildebrandt, D.V.M., Chair R.S. Chhabra, Ph.D. PATHCO, Inc. J. Frantz, V.M.D. S.L.Eustis, D.V.M., Ph.D. T.J. Goehl, Ph.D. Rohm & Haas Hamilton, D.V.M., Ph.D. R.k Griesemer, D.V.M., Ph.D. B.F. J.K Haseman, Ph.D. Experimental Pathology Laboratories, Inc. M.M. McDonald, D.V.M., Ph.D. M.P. Jokinen, D.V.M. M.M. McDonald, D.V.M., Ph.D. National Toxicology Program G.N. Rao, D.V.M., Ph.D. D. Meuten, D.V.M., Ph.D. D.B. Walters, Ph.D. North Carolina State University KL. Witt, M.S., Oak Ridge Associated Universities NTP Pathology Working Group Evaluated di&, prepared pathology report for mice (4 August 1988) Battelle Columbus Laboratories Conahcted sncdies, evaluated pathology @dings L.H. Brennecke, D.V.M., Chair Pathology Associates, Inc. B.P. Carlton, Ph.D. S.L. Eustis, D.V.M., Ph.D. P. Kurtz, Ph.D. National Toxicology Program J. Frantz, V.M.D. Rohm & Haas Experimental Pathology Laboratories, Inc. M.P. Jokinen, D.V.M. Provided pathology qualily assemt National Toxicology Program E.E. McConnell, D.V.M., Ph.D. B.F. Hamilton, D.V.M., Ph.D. National Toxicology Program K Yoshitomi, D.V.M., Ph.D. M.M. McDonald, D.V.M., Ph.D. National Toxicology Program Integrated Laboratory Systems D. Meuten, D.V.M., Ph.D. Performed quality assurance audits North Carolina State University K Yoshitomi, D.V.M., Ph.D. J.C. Bhandari, D.V.M., Ph.D., Principal Investigator Experimental Pathology Laboratories, Inc. Biotechnical Services, Inc. Edited Technical Repon L.G.Cockerham, Ph.D., Principal Investigator G.F. Corley, D.V.M. P.R. Dennis, M.C.M. B.B. Randolph, M.B.A. 3 CONTENTS ABSTRACT ................................................................. 5 EXPLANATION OF LEVELS OF EVIDENCE OF CARCINOGENIC ACTMTY ................9 PEERRENIEWPANEL. ...................................................... 10 SUMMARYOFPEERREVIEWCOMMENTS ....................................... 11 INTRODUCTION ........................................................... 15 MATERIALSANDMETHODS .................................................. 21 RESULTS. ................................................................ 27 DISCUSSION AND CONCLUSIONS .............................................. 55 REFERENCES ............................................................. 61 APPENDIXA Materials and Methods ............................................ 69 APPENDIXB Summary of Lesions in Male Rats in the 2-Year Feed Study of Ethylene Thiourea ............................................. 79 APPENDIXC Summary of Lesions in Female Rats in the 2-Year Feed Study of Ethylene Thiourea ............................................ 117 APPENDIXD Summary of Lesions in Male Mice in the 2-Year Feed Study of Ethylene Thiourea ............................................ 151 APPENDIXE Summary of Lesions in Female Mice in the 2-Year Feed Study of Ethylene Thiourea ............................................ 187 APPENDIXF Sentinel Animal Program ......................................... 221 APPENDIXG Maximum Neonatal Dose Determination .............................. 225 APPENDIXH Thyroid Function Data for Rats ..................................... 229 APPENDIXI Thyroid Function Data for Mice .................................... 235 APPENDIXJ Genetic Toxicology .............................................. 241 4 Ethylene Thiourea, NTP TR 388 5 ABSTRACT CAS NO. %-45-7 Chemical Formula: GH,N,S Molecular Weight: 102.17 Chemical 2-Imidazolidinethione- Imidazoline-2-thiol Names: i Synonyms: 2-mercaptoimidazoline; N,N ethylenethiourea; 1,3ethylenethiourea; 2-imadazoline-2-thio1 Ethylene thiourea is a white crystalline solid used ethylene thiourea in the feed beginning 2 weeks extensively in the rubber industry as an accelerator prior to breeding and continuing throughout gesta- in the vulcanization of elastomers. It is also a trace tion and lactation, and the pups were fed at these contaminant and metabolic degradation product of same concentrations up to 9 weeks postweaning. a widely used class of ethylene bisdithiocarbamate Based on decreased survival of rat pups between fungicides. Ethylene thiourea is known to produce postnatal days 0 to 4 and reduction in body weight thyroid neoplasms in rats and liver neoplasms in gains in male weanling rats receiving 250 ppm, mice following long-term administration; thus, it was dietary concentrations of 0, 9, 30, and 90 ppm were chosen by the National Toxicology Program in an selected for the perinatal (Fo)exposure levels in the investigation of the potential value of perinatal 2-year studies. Groups of 10 male and 10 female exposures in assessing chemical carcinogenicity. rats, 8 to 9 weeks of age, were fed diets containing 0, 60,125, 250, 500, or 750 ppm ethylene thiourea Chronic toxicity and carcinogenicity studies of for 13 weeks to determine the adult dietary con- ethylene thiourea, 99% pure, were conducted in centrations. Because of reduced weight gains and F344/N rats and B6C3F1 mice of each sex. The decreased feed consumption in rats receiving 500 or studies were designed to determine 1) the effects of 750 ppm ethylene thiourea, dietary concentrations of ethylene thiourea in rats and mice receiving adult 0, 25, 83, and 250 ppm were selected for the adult exposure only (a typical carcinogenicity study), (F,) exposure during the 2-year studies. 2) the toxic and carcinogenic effects of ethylene thiourea on rats and mice receiving perinatal expo- In the 2-year studies, perinatal and adult exposures sure only (dietary exposure of dams prior to to ethylene thiourea were applied separately and breeding and throughout gestation and lactation), together to groups of male or female rats as shown and 3) the effects of combined perinatal and adult in the following table. exposure to ethylene thiourea. The principal toxic effects of ethylene thiourea Studies in F344/NR& involved the thyroid gland. Serum levels of thy- In a preliminary study to determine the perinatal roxine (T4) and/or triiodothyronine (T3) were dietary concentrations for the 2-year studies, female significantly decreased in rats receiving adult con- F344/N rats were fed 0, 8, 25, 83, or 250 ppm centrations of 83 or 250 ppm, and thyrotropin 6 Ethylene Thiourea, NTP TR 388 (thyroid-stimulating hormone, TSH)was significantly Neoplasms of the
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