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TR-546: Sodium Dichromate Dihydrate (CASRN 7789-12-0)

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TR-546: Sodium Dichromate Dihydrate (CASRN 7789-12-0) NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF SODIUM DICHROMATE DIHYDRATE (CAS NO. 7789-12-0) IN F344/N RATS AND B6C3F1 MICE (DRINKING WATER STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 July 2008 NTP TR 546 NIH Publication No. 08-5887 National Institutes of Health Public Health Service U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOREWORD The National Toxicology Program (NTP) is an interagency program within the Public Health Service (PHS) of the Department of Health and Human Services (HHS) and is headquartered at the National Institute of Environmental Health Sciences of the National Institutes of Health (NIEHS/NIH). Three agencies contribute resources to the program: NIEHS/NIH, the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention (NIOSH/CDC), and the National Center for Toxicological Research of the Food and Drug Administration (NCTR/FDA). Established in 1978, the NTP is charged with coordinating toxicological testing activities, strengthening the science base in toxicology, developing and validating improved testing methods, and providing information about potentially toxic substances to health regulatory and research agencies, scientific and medical communities, and the public. The Technical Report series began in 1976 with carcinogenesis studies conducted by the National Cancer Institute. In 1981, this bioassay program was transferred to the NTP. The studies described in the Technical Report series are designed and conducted to characterize and evaluate the toxicologic potential, including carcinogenic activity, of selected substances in laboratory animals (usually two species, rats and mice). Substances selected for NTP toxicity and carcinogenicity studies are chosen primarily on the basis of human exposure, level of production, and chemical structure. The interpretive conclusions presented in NTP Technical Reports are based only on the results of these NTP studies. Extrapolation of these results to other species, including characterization of hazards and risks to humans, requires analyses beyond the intent of these reports. Selection per se is not an indicator of a substance’s carcinogenic potential. The NTP conducts its studies in compliance with its laboratory health and safety guidelines and FDA Good Laboratory Practice Regulations and must meet or exceed all applicable federal, state, and local health and safety regulations. Animal care and use are in accordance with the Public Health Service Policy on Humane Care and Use of Animals. Studies are subjected to retrospective quality assurance audits before being presented for public review. NTP Technical Reports are indexed in the NIH/NLM PubMed database and are available free of charge electronically on the NTP website (http://ntp.niehs.nih.gov) or in hardcopy upon request from the NTP Central Data Management group at [email protected] or (919) 541-3419. NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF SODIUM DICHROMATE DIHYDRATE (CAS NO. 7789-12-0) IN F344/N RATS AND B6C3F1 MICE (DRINKING WATER STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 July 2008 NTP TR 546 NIH Publication No. 08-5887 National Institutes of Health Public Health Service U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 2 CONTRIBUTORS National Toxicology Program NTP Pathology Working Group Evaluated and interpreted results and reported findings Evaluated slides and prepared pathology report on rats (September 26, 2006) M.J. Hooth, Ph.D., Study Scientist M.P. Jokinen, D.V.M., Chairperson R.A. Herbert, D.V.M., Ph.D., Study Pathologist Pathology Associates, A Charles River Company D.W. Bristol, Ph.D. J.M. Cullen, V.M.D., Ph.D. J.R. Bucher, Ph.D. North Carolina State University L.T. Burka, Ph.D. S.A. Elmore, D.V.M., M.S. R.S. Chhabra, Ph.D. National Toxicology Program B.J. Collins, M.S. G.P. Flake, M.D. A.P. King-Herbert, D.V.M. National Toxicology Program G.E. Kissling, Ph.D. R.A. Herbert, D.V.M., Ph.D. D.E. Malarkey, D.V.M., Ph.D. National Toxicology Program S.D. Peddada, Ph.D. W.G. Lieuallen, D.V.M., Ph.D. Pathology Associates, A Charles River Company J.H. Roycroft, Ph.D. D.E. Malarkey, D.V.M., Ph.D. C.S. Smith, Ph.D. National Toxicology Program G.S. Travlos, D.V.M. E.E. McConnell, D.V.M., M.S. K.L. Witt, M.S. ToxPath, Inc. R.A. Miller, D.V.M., Ph.D. Southern Research Institute Experimental Pathology Laboratories, Inc. Conducted studies and evaluated pathology findings J.C. Peckham, D.V.M., M.S., Ph.D. Experimental Pathology Laboratories, Inc. C.D. Hébert, Ph.D., Principal Investigator Evaluated slides and prepared pathology report on mice J.E. Heath, D.V.M. (November 9, 2006) R.B. Thompson, D.V.M., Ph.D. M.P. Jokinen, D.V.M., Chairperson Experimental Pathology Laboratories, Inc. Pathology Associates, A Charles River Company Provided pathology review S.A. Elmore, D.V.M., M.S. National Toxicology Program M.H. Hamlin, II, D.V.M., Principal Investigator R.A. Herbert, D.V.M., Ph.D. R.A. Miller, D.V.M., Ph.D. National Toxicology Program J.C. Peckham, D.V.M., M.S., Ph.D. D.E. Malarkey, D.V.M., Ph.D. National Toxicology Program C.C. Shackelford, D.V.M., M.S., Ph.D. R.R. Maronpot, D.V.M. National Toxicology Program Dynamac Corporation J.C. Peckham, D.V.M., M.S., Ph.D. Prepared quality assessment audits Experimental Pathology Laboratories, Inc. C.C. Shackelford, D.V.M., M.S., Ph.D. S. Brecher, Ph.D., Principal Investigator Experimental Pathology Laboratories, Inc. S. Iyer, B.S. V. Tharakan, D.V.M. Sodium Dichromate Dihydrate, NTP TR 546 3 Constella Group, Inc. Biotechnical Services, Inc. Provided statistical analyses Prepared Technical Report P.W. Crockett, Ph.D., Principal Investigator S.R. Gunnels, M.A., Principal Investigator L.J. Betz, M.S. P.A. Gideon, B.A. M.R. Easterling, Ph.D. B.F. Hall, M.S. K.P. McGowan, M.B.A. L.M. Harper, B.S. D.C. Serbus, Ph.D. G.E. Simmons, M.A. 4 CONTENTS ABSTRACT . 7 EXPLANATION OF LEVELS OF EVIDENCE OF CARCINOGENIC ACTIVITY................. 12 TECHNICAL REPORTS REVIEW SUBCOMMITTEE........................................ 13 SUMMARY OF TECHNICAL REPORTS REVIEW SUBCOMMITTEE COMMENTS............. 14 INTRODUCTION . 17 MATERIALS AND METHODS . 23 RESULTS ............................................................................... 31 DISCUSSION AND CONCLUSIONS........................................................ 65 REFERENCES........................................................................... 71 APPENDIX A Summary of Lesions in Male Rats in the 2-Year Drinking Water Study of Sodium Dichromate Dihydrate ............................................. 79 APPENDIX B Summary of Lesions in Female Rats in the 2-Year Drinking Water Study of Sodium Dichromate Dihydrate ............................................. 97 APPENDIX C Summary of Lesions in Male Mice in the 2-Year Drinking Water Study of Sodium Dichromate Dihydrate ............................................. 113 APPENDIX D Summary of Lesions in Female Mice in the 2-Year Drinking Water Study of Sodium Dichromate Dihydrate ............................................. 131 APPENDIX E Clinical Pathology Results . 147 APPENDIX F Chemical Characterization and Dose Formulation Studies ........................ 157 APPENDIX G Water and Compound Consumption in the 2-Year Drinking Water Studies of Sodium Dichromate Dihydrate ............................................. 169 APPENDIX H Ingredients, Nutrient Composition, and Contaminant Levels in NTP-2000 Rat and Mouse Ration........................................... 179 APPENDIX I Sentinel Animal Program.................................................... 183 APPENDIX J Chromium Tissue Distribution Study.......................................... 187 Sodium Dichromate Dihydrate, NTP TR 546 5 SUMMARY Background Chromium is a metal that exists in a variety of valence states, depending on surrounding conditions and what other atoms it is bound to. The most stable forms are metallic chromium, trivalent chromium (chromium III), and hexavalent chromium (chromium VI). Chromium VI has already been shown to cause cancer when inhaled in the air. Because some compounds containing chromium VI occur as contaminants in drinking water, we studied the effects of sodium dichromate dihydrate in drinking water on male and female rats and mice to identify potential toxic or cancer-related hazards. Methods We gave drinking water containing 14.3, 57.3, 172, or 516 mg of sodium dichromate dihydrate per liter of water to groups of 50 male and female rats and female mice for 2 years. Similar groups of male mice were given 14.3, 28.6, 85.7, or 257.4 mg of sodium dichromate dihydrate per liter of water. Control animals received the same tap water with no chemical added. At the end of the study, tissues from more than 40 sites were examined for every animal. Results Male and female rats exposed to sodium dichromate dihydrate had carcinomas of the mouth, but none occurred in the control rats. Male and female mice receiving sodium dichromate dihydrate had greatly increased rates of cancer of the small intestine. Conclusions We conclude that sodium dichromate dihydrate in the drinking water caused oral cancers in rats and cancer of the small intestine in mice. 6 Sodium Dichromate Dihydrate, NTP TR 546 7 ABSTRACT SODIUM DICHROMATE DIHYDRATE CAS No. 7789-12-0 Chemical Formula: Na2Cr2O7 • 2H2O Molecular Weight: 298.0 Synonyms: Chromic acid; dichromic acid, dihydrate; disodium dichromate dihydrate; chromium VI Sodium dichromate dihydrate
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