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Cobalt Sulfate Heptahydrate NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF COBALT SULFATE HEPTAHYDRATE (CAS NO. 10026-24-1) IN F344/N RATS AND B6C3F1 MICE (INHALATION STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 August 1998 NTP TR 471 NIH Publication No. 98-3961 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 COBALT SULFATE HEPTAHYDRATE (CAS NO. 10026-24-1) IN F344/N RATS AND B6C3F1 MICE (INHALATION STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 August 1998 NTP TR 471 NIH Publication No. 98-3961 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health 2 Cobalt Sulfate Heptahydrate, NTP TR 471 CONTRIBUTORS National Toxicology Program NTP Pathology Working Group Evaluated and interpreted results and reported findings Evaluated slides, prepared pathology report on rats (26 April 1996) J.R. Bucher, Ph.D., Study Scientist D.A. Bridge, B.S. M.P. Jokinen, D.V.M., Chairperson R.E. Chapin, Ph.D. Pathology Associates International D. Dixon, D.V.M., Ph.D. J.R. Hailey, D.V.M. National Toxicology Program J.K. Haseman, Ph.D. J. Everitt, D.V.M. R.R. Maronpot, D.V.M. Chemical Industry Institute of Toxicology G.N. Rao, D.V.M., Ph.D. S.L. Grumbein, D.V.M., Ph.D. J.H. Roycroft, Ph.D. Battelle Pacific Northwest Laboratories C.S. Smith, Ph.D. F.F. Hahn, D.V.M., Ph.D. IIT Research Institute G.S. Travlos, D.V.M. J.R. Hailey, D.V.M. D.B. Walters, Ph.D. National Toxicology Program K.L. Witt, M.S., Oak Ridge Associated Universities R.A. Herbert, D.V.M., Ph.D. National Toxicology Program Battelle Pacific Northwest Laboratories R.R. Maronpot, D.V.M. Conducted studies, evaluated pathology findings National Toxicology Program A. Nyska, D.V.M. B.J. Chou, D.V.M., Ph.D., Principal Investigator National Toxicology Program J.A. Dill, Ph.D. C.C. Shackelford, D.V.M., M.S., Ph.D. S.L. Grumbein, D.V.M., Ph.D. Experimental Pathology Laboratories, Inc. P.W. Mellick, D.V.M., Ph.D. Evaluated slides, prepared pathology report on mice S.E. Rowe, D.V.M., M.S. (29 February 1996) M.P. Jokinen, D.V.M., Chairperson Experimental Pathology Laboratories, Inc. Pathology Associates International Provided pathology quality assurance D. Dixon, D.V.M., Ph.D. National Toxicology Program J.F. Hardisty, D.V.M., Principal Investigator M.R. Elwell, D.V.M., Ph.D. M.R. Elwell, D.V.M., Ph.D. Experimental Pathology Laboratories, Inc. C.C. Shackelford, D.V.M., M.S., Ph.D. J. Everitt, D.V.M. Chemical Industry Institute of Toxicology Dynamac Corporation J.R. Hailey, D.V.M. National Toxicology Program Prepared quality assurance audits R.A. Herbert, D.V.M., Ph.D. National Toxicology Program S. Brecher, Ph.D., Principal Investigator R.R. Maronpot, D.V.M. National Toxicology Program A. Nyska, D.V.M. National Toxicology Program A. Radovsky, D.V.M., Ph.D. National Toxicology Program Cobalt Sulfate Heptahydrate, NTP TR 471 3 Analytical Sciences, Inc. Biotechnical Services, Inc. Provided statistical analyses Prepared Technical Report R.W. Morris, M.S., Principal Investigator S.R. Gunnels, M.A., Principal Investigator S.R. Lloyd, M.S. L.M. Harper, B.S. N.G. Mintz, B.S. A.M. Macri-Hanson, M.A., M.F.A. 4 CONTENTS ABSTRACT ............................................................. 5 EXPLANATION OF LEVELS OF EVIDENCE OF CARCINOGENIC ACTIVITY ............. 10 TECHNICAL REPORTS REVIEW SUBCOMMITTEE ................................ 11 SUMMARY OF TECHNICAL REPORTS REVIEW SUBCOMMITTEE COMMENTS .......... 12 INTRODUCTION ......................................................... 13 MATERIALS AND METHODS ................................................ 21 RESULTS ............................................................... 29 DISCUSSION AND CONCLUSIONS ............................................ 51 REFERENCES ........................................................... 55 APPENDIX A Summary of Lesions in Male Rats in the 2-Year Inhalation Study of Cobalt Sulfate Heptahydrate ..................................... 63 APPENDIX B Summary of Lesions in Female Rats in the 2-Year Inhalation Study of Cobalt Sulfate Heptahydrate ..................................... 105 APPENDIX C Summary of Lesions in Male Mice in the 2-Year Inhalation Study of Cobalt Sulfate Heptahydrate ..................................... 139 APPENDIX D Summary of Lesions in Female Mice in the 2-Year Inhalation Study of Cobalt Sulfate Heptahydrate ..................................... 173 APPENDIX E Genetic Toxicology ............................................. 209 APPENDIX F Chemical Characterization and Generation of Chamber Concentrations ......... 213 APPENDIX G Ingredients, Nutrient Composition, and Contaminant Levels in NIH-07 Rat and Mouse Ration .................................... 225 APPENDIX H Sentinel Animal Program ......................................... 229 APPENDIX I K-ras Mutation Frequency and Spectra in Lung Neoplasms from B6C3F1 Mice Exposed to Cobalt Sulfate Heptahydrate for 2 Years ......... 233 APPENDIX J Impact of Helicobacter Hepaticus Infection in B6C3F1 Mice from 12 NTP 2-Year Carcinogenesis Studies ............................ 241 5 ABSTRACT CoSO CC 7H O 4 2 COBALT SULFATE HEPTAHYDRATE CAS No. 10026-24-1 Molecular Weight: 281.13 Synonyms: Bieberite; cobalt(II) sulfate (1:1) heptahydrate; cobalt monosulfate heptahydrate; cobalt(II) sulphate heptahydrate; sulfuric acid, cobalt(2+) salt (1:1) heptahydrate Cobalt sulfate is used in the electroplating and electro­ Survival and Body Weights chemical industries. It is also used as a coloring agent Survival of exposed males and females was similar to for ceramics and as a drying agent in inks, paints, that of the chamber controls. Mean body weights of varnishes, and linoleum. Cobalt sulfate may be added exposed male and female rats were similar to those of to animal feed as a mineral supplement and has been the chamber controls throughout the study. used as a top dressing on pasture lands. Cobalt sulfate was nominated by the National Cancer Institute for Pathology Findings study based on a lack of information on the toxicity of The incidences and severities of proteinosis, alveolar soluble salts. Male and female F344/N rats and epithelial metaplasia, granulomatous alveolar inflam­ B6C3F1 mice were exposed to cobalt sulfate mation, and interstitial fibrosis were markedly greater heptahydrate (approximately 99% pure) by inhalation in all exposed groups of male and female rats than in for 2 years. Genetic toxicology studies were con­ the chamber controls. The incidences of alveolar ducted in Salmonella typhimurium. The results of epithelial hyperplasia in all groups of exposed males prechronic inhalation toxicity studies were reported and in females exposed to
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