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Sodium Bromate (Cas No NTP REPORT ON THE TOXICOLOGY STUDIES OF SODIUM BROMATE (CAS NO. 7789-38-0) IN GENETICALLY MODIFIED (FVB Tg.AC HEMIZYGOUS) MICE (DERMAL AND DRINKING WATER STUDIES) AND CARCINOGENICITY STUDIES OF SODIUM BROMATE IN GENETICALLY MODIFIED [B6.129-Trp53tm1Brd (N5) HAPLOINSUFFICIENT] MICE (DRINKING WATER STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 March 2007 NTP GMM 6 NIH Publication No. 07-4423 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 Genetically Modified Model (GMM) Report series began in 2005 with studies conducted by the NTP. The studies described in the GMM Report series are designed and conducted to characterize and evaluate the toxicologic potential, including carcinogenic activity, of selected agents in laboratory animals that have been genetically modified. These genetic modifications may involve inactivation of selected tumor suppressor functions or activation of oncogenes that are commonly observed in human cancers. This may result in a rapid onset of cancer in the genetically modified animal when exposure is to agents that act directly or indirectly on the affected pathway. An absence of a carcinogenic response may reflect either an absence of carcinogenic potential of the agent or that the selected model does not harbor the appropriate genetic modification to reduce tumor latency and allow detection of carcinogenic activity under the conditions of these subchronic studies. 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 GMM 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 GMM 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 REPORT ON THE TOXICOLOGY STUDIES OF SODIUM BROMATE (CAS NO. 7789-38-0) IN GENETICALLY MODIFIED (FVB Tg.AC HEMIZYGOUS) MICE (DERMAL AND DRINKING WATER STUDIES) AND CARCINOGENICITY STUDIES OF SODIUM BROMATE IN GENETICALLY MODIFIED [B6.129-Trp53tm1Brd (N5) HAPLOINSUFFICIENT] MICE (DRINKING WATER STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 March 2007 NTP GMM 6 NIH Publication No. 07-4423 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 mice (July 16, 2002) M.J. Hooth, Ph.D., Study Scientist S. Rouselle, D.V.M., Chairperson J.C. Peckham, D.V.M., M.S., Ph.D., Study Pathologist Pathology Associates, A Charles River Company D.W. Bristol, Ph.D. K.J. Cimon, D.V.M., M.S. J.R. Bucher, Ph.D. Experimental Pathology Laboratories, Inc. L.T. Burka, Ph.D. R.A. Herbert, D.V.M., Ph.D. R.S. Chhabra, Ph.D. National Toxicology Program J.E. French, Ph.D. P.C. Howroyd, M.A., Vet.M.B. R.A. Herbert, D.V.M., Ph.D. Experimental Pathology Laboratories, Inc. A.P. King-Herbert, D.V.M. G. Pearse, B.V.M. & S. G.E. Kissling, Ph.D. National Toxicology Program D.E. Malarkey, D.V.M., Ph.D. J.C. Peckham, D.V.M., M.S., Ph.D. Experimental Pathology Laboratories, Inc. R.R. Maronpot, D.V.M. D. Wolf, D.V.M., Ph.D. S.D. Peddada, Ph.D. Environmental Protection Agency C.S. Smith, Ph.D. G.S. Travlos, D.V.M. Constella Group, Inc. M.K. Vallant, B.S., M.T. Provided statistical analyses K.L. Witt, M.S. P.W. Crockett, Ph.D., Principal Investigator Battelle Columbus Operations L.J. Betz, M.S. Conducted studies and evaluated pathology findings K.P. McGowan, M.B.A. M.R. Hejtmancik, Ph.D., Principal Investigator Biotechnical Services, Inc. J.D. Johnson, Ph.D. Prepared Report M.J. Ryan, D.V.M., Ph.D. S.R. Gunnels, M.A., Principal Investigator Experimental Pathology Laboratories, Inc. P.H. Carver, B.A. Provided pathology review B.F. Hall, M.S. L.M. Harper, B.S. M.H. Hamlin, II, D.V.M., Principal Investigator D.C. Serbus, Ph.D. K.J. Cimon, D.V.M., M.S. P.C. Howroyd, M.A., Vet.M.B. J.C. Peckham, D.V.M., M.S., Ph.D. Dynamac Corporation Prepared quality assurance audits S. Brecher, Ph.D., Principal Investigator 3 CONTENTS ABSTRACT . 5 EXPLANATION OF LEVELS OF EVIDENCE OF CARCINOGENIC ACTIVITY . 11 TECHNICAL REPORTS REVIEW SUBCOMMITTEE . 12 SUMMARY OF TECHNICAL REPORTS REVIEW SUBCOMMITTEE COMMENTS . 13 INTRODUCTION . 15 MATERIALS AND METHODS . 25 RESULTS . 33 DISCUSSION AND CONCLUSIONS . 73 REFERENCES . 77 APPENDIX A Summary of Lesions in Tg.AC Hemizygous Mice in the Dermal Studies of Sodium Bromate . 85 APPENDIX B Summary of Lesions in Tg.AC Hemizygous Mice in the Drinking Water Studies of Sodium Bromate . 103 APPENDIX C Summary of Lesions in p53 Haploinsufficient Mice in the Drinking Water Studies of Sodium Bromate . 119 APPENDIX D Genetic Toxicology . 137 APPENDIX E Clinical Pathology Results . 141 APPENDIX F Organ Weights and Organ-Weight-to-Body-Weight Ratios . 145 APPENDIX G Chemical Characterization and Dose Formulation Studies . 153 APPENDIX H Water and Compound Consumption in the 27- and 43-Week Drinking Water Studies of Sodium Bromate . 161 4 Sodium Bromate, NTP GMM 6 SUMMARY Background Sodium bromate is a by-product of water disinfection. We tested if sodium bromate could cause cancer in two different strains of genetically modified mice. Methods We applied solutions containing sodium bromate to the backs of male and female Tg.AC mice for 6 or 9 months, and gave sodium bromate dissolved in drinking water to male and female Tg.AC and p53 mice for 6 or 10 months. The ethanol/water vehicle without any chemical was applied to the backs of control mice in the dermal studies, and animals given plain water served as the control groups for the drinking water studies. Tissues from 15 sites were examined for every animal. Results Exposure to sodium bromate either through the skin or by drinking water decreased body weights in groups given the highest concentrations. No increases in tumors were seen in males or females from either strain of mice. Conclusions We conclude that sodium bromate did not cause cancer in the genetically modified mice used in these studies. This chemical did cause cancer in other studies with different rodents, and thus these genetically modified mice may not be as sensitive for detecting certain cancer-causing compounds. 5 ABSTRACT O Na O Br O SODIUM BROMATE CAS No. 7789-38-0 Chemical Formula: NaBrO3 Molecular Weight: 150.9 Synonyms: Bromic acid, sodium salt Trade names: Dyetone, Neutralizer K-126, Neutralizer K-140, Neutralizer K-938 Bromate is a drinking water disinfection by-product 26- AND 39-WEEK DERMAL STUDIES formed during the ozonation of source water containing IN EMIZYGOUS ICE bromide. Sodium bromate is also used as an analytical Tg.AC H M reagent, in the oxidation of sulfur and vat dyes, and for Groups of 15 male and 15 female Tg.AC hemizygous cleaning boilers. As a mixture with sodium bromide, it mice received dermal applications of 0, 64, 128, or is used for dissolving gold from its ores. The cosmetic 256 mg sodium bromate/kg body weight in ethanol/ water, 5 days per week for 26 weeks. Additional groups industry uses sodium bromate and potassium bromate as of 10 male and 10 female Tg.AC hemizygous mice were neutralizers or oxidizers in hair wave preparations. dermally administered the same doses for 39 weeks. Sodium bromate was nominated for toxicity and car­ Survival of dosed groups was similar to that of vehicle cinogenicity studies in transgenic mouse models by the control groups at 26 and 39 weeks. Mean body weights United States Environmental Protection Agency and the of 256 mg/kg males were less than those of the vehicle National Institute of Environmental Health Sciences. control group in both studies. Mean body weights of all Male and female Tg.AC hemizygous mice received dosed groups of females were less than those of the vehi­ sodium bromate by dermal application for 26 or cle controls at 39 weeks.
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