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TR-483: Pentachlorophenol (CASRN 87-86-5) in F344/N Rats

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TR-483: Pentachlorophenol (CASRN 87-86-5) in F344/N Rats NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF PENTACHLOROPHENOL (CAS NO. 87-86-5) IN F344/N RATS (FEED STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 April 1999 NTP TR 483 NIH Publication No. 99-3973 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 (NCTR), 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. The prechronic and chronic studies were conducted in compliance with Food and Drug Administration (FDA) Good Laboratory Practice Regulations, and 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. The interpretive conclusions presented in this Technical Report are based only on the results of these NTP studies. Extrapolation of these results to other species and quantitative risk analyses for humans require wider analyses beyond the purview of these studies. Selection per se is not an indicator of a chemical’s carcinogenic potential. Listings of all published NTP reports and ongoing studies are available from NTP Central Data Management, NIEHS, P.O. Box 12233, MD E1-02, Research Triangle Park, NC 27709 (919-541-3419). The Abstracts and other study information for 2-year studies are also available at the NTP’s World Wide Web site: http://ntp-server.niehs.nih.gov. NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF PENTACHLOROPHENOL (CAS NO. 87-86-5) IN F344/N RATS (FEED STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 April 1999 NTP TR 483 NIH Publication No. 99-3973 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health 2 Pentachlorophenol, NTP TR 483 CONTRIBUTORS National Toxicology Program NTP Pathology Working Group Evaluated and interpreted results and reported findings Evaluated slides, prepared pathology report (25 March 1997) R.S. Chhabra, Ph.D., Study Scientist M.P. Jokinen, D.V.M., Chairperson D.A. Bridge, B.S. Pathology Associates International J.R. Bucher, Ph.D. R. Cattley, V.M.D., Ph.D. R.E. Chapin, Ph.D. Chemical Industry Institute of Toxicology J.R. Hailey, D.V.M. E.T. Gaillard, M.S., D.V.M. Experimental Pathology Laboratories, Inc. J.K. Haseman, Ph.D. J.R. Hailey, D.V.M. R.A. Herbert, D.V.M., Ph.D. National Toxicology Program R.R. Maronpot, D.V.M. R.A. Herbert, D.V.M., Ph.D. G.N. Rao, D.V.M., Ph.D. National Toxicology Program J.H. Roycroft, Ph.D. J.R. Leininger, D.V.M., Ph.D. C.S. Smith, Ph.D. National Toxicology Program G.S. Travlos, D.V.M. J.B. Nold, D.V.M., Ph.D., Observer D.B. Walters, Ph.D. Pathology Associates International R.C. Sills, D.V.M., Ph.D. K.L. Witt, M.S., Integrated Laboratory Systems National Toxicology Program J.A. Swenberg, D.V.M., Ph.D., Observer Battelle Columbus Laboratories University of North Carolina Conducted studies, evaluated pathology findings Analytical Sciences, Inc. M.R. Hejtmancik, Ph.D., Principal Investigator Provided statistical analyses P.J. Kurtz, Ph.D., Principal Investigator J.D. Toft II, D.V.M., M.S. R.W. Morris, M.S., Principal Investigator S.R. Lloyd, M.S. Experimental Pathology Laboratories, Inc. N.G. Mintz, B.S. Provided pathology quality assurance Biotechnical Services, Inc. J.F. Hardisty, D.V.M., Principal Investigator Prepared Technical Report E.T. Gaillard, M.S., D.V.M. S.R. Gunnels, M.A., Principal Investigator Dynamac Corporation L.M. Harper, B.S. Prepared quality assurance audits T.S. Kumpe, M.A. A.M. Macri-Hanson, M.A., M.F.A. S. Brecher, Ph.D., Principal Investigator 3 CONTENTS ABSTRACT ............................................................. 5 EXPLANATION OF LEVELS OF EVIDENCE OF CARCINOGENIC ACTIVITY ............. 9 TECHNICAL REPORTS REVIEW SUBCOMMITTEE ................................ 10 SUMMARY OF TECHNICAL REPORTS REVIEW SUBCOMMITTEE COMMENTS .......... 11 INTRODUCTION ......................................................... 13 MATERIALS AND METHODS ................................................ 21 RESULTS ............................................................... 29 DISCUSSION AND CONCLUSIONS ............................................ 47 REFERENCES ........................................................... 53 APPENDIX A Summary of Lesions in Male Rats in the 2-Year Feed Study of Pentachlorophenol ............................................ 61 APPENDIX B Summary of Lesions in Female Rats in the 2-Year Feed Study of Pentachlorophenol ............................................ 111 APPENDIX C Genetic Toxicology ............................................. 149 APPENDIX D Clinical Chemistry Results ........................................ 157 APPENDIX E Liver Weights and Liver-Weight-to-Body-Weight Ratios .................... 159 APPENDIX F Chemical Characterization and Dose Formulation Studies ................... 163 APPENDIX G Feed and Compound Consumption in the 2-Year Feed Studies of Pentachlorophenol ............................................ 171 APPENDIX H Ingredients, Nutrient Composition, and Contaminant Levels in NIH-07 Rat and Mouse Ration ................................... 177 APPENDIX I Sentinel Animal Program ......................................... 181 4 Pentachlorophenol, NTP TR 483 5 ABSTRACT PENTACHLOROPHENOL CAS No. 87-86-5 Chemical Formula: CHOCl Molecular Weight: 266.3 Synonyms: Chlorophen; PCP; penchlorol; penta; pentachlorofenol; pentachlorofenolo; 2,3,4,5,6-pentachlorophenol Trade names: Acutox; Chem-Penta; Chem-Tol; Cryptogil ol; Dowicide 7; Dowicide EC-7; Dow Pentachlorophenol DP-2 Antimicrobial; Durotox; EP 30; Fungifen; Fungol; Glazd Penta; Grundier Arbezol Lauxtol; Lauxtol A; Liroprem; Moosuran; Pentacon; Penta-Kil; Pentasol; Penwar; Peratox; Permacide; Permagard; Permasan; Permatox; Priltox; Permite; Santophen; Santophen 20; Sinituho; Term-i-Trol; Thompson’s Wood Fix; Weedone; Witophen P Pentachlorophenol has been used as an herbicide, cultured Chinese hamster ovary cells and in vivo in rat algicide, defoliant, wood preservative, germicide, and mouse bone marrow cells. fungicide, and molluscicide. Pentachlorophenol was nominated by the National Cancer Institute for 28-DAY STUDY IN RATS carcinogenicity testing based on its widespread use as Groups of 10 male and 10 female F344/N rats were a wood preservative, potential for entering the envi­ given 0, 200, 400, 800, 1,600, or 3,200 ppm penta­ ronment (pentachlorophenol residues have been found chlorophenol, equivalent to average daily doses of worldwide in soil, water, and air samples; in food approximately 20, 40, 75, 150, or 270 mg penta­ products; and in human and animal tissues and body chlorophenol/kg body weight to males and females in fluids), and likelihood of bioaccumulation in the envi­ feed for 28 days. With the exception of one male and ronment (pentachlorophenol is persistent in soil, two females exposed to 3,200 ppm, all rats survived having a half-life of up to 5 years). Technical Report until the end of the study. The final mean body No. 349 contains the results of the 2-year studies of weights and body weight gains of male rats exposed pentachlorophenol performed by the NTP with to 1,600 or 3,200 ppm and female rats exposed to B6C3F mice. 400, 800, 1,600, or 3,200 ppm were significantly less Male and female F344/N rats were exposed to penta­ than those of the controls; rats exposed to 3,200 ppm chlorophenol (approximately 99% pure) in feed for lost weight during the study. Feed consumption by 28 days or 2 years. Genetic toxicology studies were 3,200 ppm males was less than that by the control conducted in vitro in Salmonella typhimurium and group throughout the study. The absolute and relative 6 Pentachlorophenol, NTP TR 483 liver weights of 400, 800, and 1,600 ppm males and control male, three 200 ppm males, one 400 ppm all exposed groups of females were significantly
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