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TR-499: Indium Phosphide (CASRN 22398-80-7) in F344/N Rats And

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TR-499: Indium Phosphide (CASRN 22398-80-7) in F344/N Rats And NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF INDIUM PHOSPHIDE (CAS NO. 22398-80-7) IN F344/N RATS AND B6C3F1 MICE (INHALATION STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 July 2001 NTP TR 499 NIH Publication No. 01-4433 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 and Prevention. 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. Details about ongoing and completed NTP studies are available at the NTP«s World Wide Web site: http://ntp-server.niehs.nih.gov. Abstracts of all NTP Technical Reports and full versions of the most recent reports and other publications are available from the NIEHS« Environmental Health Information Service (EHIS) http://ehis.niehs.nih.gov (800-315-3010 or 919-541-3841). In addition, printed copies of these reports are available from EHIS as supplies last. A listing of all the NTP Technical Reports printed since 1982 appears on the inside back cover. NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF INDIUM PHOSPHIDE (CAS NO. 22398-80-7) IN F344/N RATS AND B6C3F1 MICE (INHALATION STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 July 2001 NTP TR 499 NIH Publication No. 01-4433 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health 2 CONTRIBUTORS National Toxicology Program NTP Pathology Working Group Evaluated and interpreted results and reported findings Evaluated slides and prepared pathology report on rats (2 September 1999) J.H. Roycroft, Ph.D., Study Scientist D.W. Bristol, Ph.D. J.C. Seely, D.V.M., Chairperson J.R. Bucher, Ph.D. PATHCO, Inc. A. Brix, D.V.M., Ph.D. R.E. Chapin, Ph.D. Experimental Pathology Laboratories, Inc. J.R. Hailey, D.V.M. S. Ching, D.V.M., Ph.D. J.K. Haseman, Ph.D. SVC Associates, Inc. R.R. Maronpot, D.V.M. J. Everitt, D.V.M. D.P. Orzech, M.S. Chemical Industry Institute of Toxicology G.N. Rao, D.V.M., Ph.D. S.L. Grumbein, D.V.M., Ph.D. C.S. Smith, Ph.D. Battelle Pacific Northwest Laboratories J.R. Hailey, D.V.M. G.S. Travlos, D.V.M. National Toxicology Program K.L. Witt, M.S., Integrated Laboratory Systems, Inc. R.A. Herbert, D.V.M., Ph.D. National Toxicology Program Battelle Pacific Northwest Laboratories A. Hubbs, D.V.M., Ph.D., Observer Conducted studies and evaluated pathology findings National Institute for Occupational Safety and Health E.E. McConnell, D.V.M., M.S. B.J. Chou, D.V.M., Ph.D., Principal Investigator ToxPath, Inc. J.A. Dill, Ph.D. A. Nyska, D.V.M. S.L. Grumbein, D.V.M., Ph.D. National Toxicology Program K.M. Lee, Ph.D. Evaluated slides and prepared pathology report on mice P.W. Mellick, D.V.M., Ph.D. (19 October 1999) R.A. Miller, D.V.M., Ph.D. H.A. Ragan, D.V.M. J.C. Seely, D.V.M., Chairperson Y.F. Su, Ph.D. PATHCO, Inc. A. Brix, D.V.M., Ph.D. Experimental Pathology Laboratories, Inc. Experimental Pathology Laboratories, Inc. S. Ching, D.V.M., Ph.D. Provided pathology quality assurance Integrated Laboratory Systems, Inc. J. Everitt, D.V.M. J.F. Hardisty, D.V.M., Principal Investigator Chemical Industry Institute of Toxicology A. Brix, D.V.M., Ph.D. J.R. Hailey, D.V.M. National Toxicology Program Dynamac Corporation A. Hubbs, D.V.M., Ph.D. Prepared quality assurance audits National Institute for Occupational Safety and Health E.E. McConnell, D.V.M., M.S. S. Brecher, Ph.D., Principal Investigator ToxPath, Inc. G. Marit, D.V.M., Observer Battelle Columbus Laboratories R.A. Miller, D.V.M., Ph.D. Battelle Pacific Northwest Laboratories A. Nyska, D.V.M. National Toxicology Program Indium Phosphide, NTP TR 499 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 L.J. Betz, M.S. L.M. Harper, B.S. K.P. McGowan, M.B.A. L.M. Leach, B.A. J.T. Scott, M.S. D.C. Serbus, Ph.D. P.A. Yount, B.S. 4 CONTENTS ABSTRACT ............................................................................ 7 EXPLANATION OF LEVELS OF EVIDENCE OF CARCINOGENIC ACTIVITY ................ 13 TECHNICAL REPORTS REVIEW SUBCOMMITTEE ....................................... 14 SUMMARY OF TECHNICAL REPORTS REVIEW SUBCOMMITTEE COMMENTS ............ 15 INTRODUCTION ....................................................................... 17 MATERIALS AND METHODS ........................................................... 25 RESULTS .............................................................................. 37 DISCUSSION AND CONCLUSIONS ....................................................... 91 REFERENCES.......................................................................... 97 APPENDIX A Summary of Lesions in Male Rats in the 2-Year Inhalation Study of Indium Phosphide ....................................................... 103 APPENDIX B Summary of Lesions in Female Rats in the 2-Year Inhalation Study of Indium Phosphide ....................................................... 149 APPENDIX C Summary of Lesions in Male Mice in the 2-Year Inhalation Study of Indium Phosphide ....................................................... 185 APPENDIX D Summary of Lesions in Female Mice in the 2-Year Inhalation Study of Indium Phosphide ....................................................... 229 APPENDIX E Genetic Toxicology ........................................................ 269 APPENDIX F Clinical Pathology Results .................................................. 273 APPENDIX G Organ Weights and Organ-Weight-to-Body-Weight Ratios ....................... 285 APPENDIX H Tissue Burden Results...................................................... 291 APPENDIX I Reproductive Tissue Evaluations and Estrous Cycle Characterization ............. 309 APPENDIX J Chemical Characterization and Generation of Chamber Concentrations ........... 313 APPENDIX K Ingredients, Nutrient Composition, and Contaminant Levels in NTP-2000 Rat and Mouse Ration .......................................... 327 Indium Phosphide, NTP TR 499 5 APPENDIX L Sentinel Animal Program .................................................. 331 APPENDIX M Mutations of $$$-Catenin and H-ras in Hepatocellular Adenomas and Carcinomas of B6C3F1 Mice Exposed to Indium Phosphide for 2 Years ....................... 335 6 Indium Phosphide, NTP TR 499 7 ABSTRACT InP INDIUM PHOSPHIDE CAS No. 22398-80-7 Chemical Formula: InP Molecular Weight: 145.80 Indium phosphide is used to make semiconductors, were significantly enlarged, weighing 2.7- to 4.4-fold injection lasers, solar cells, photodiodes, and light- more than those of the chamber controls. Indium phos- emitting diodes. Indium phosphide was nominated for phide particles were observed throughout the respira- study because of its widespread use in the micro- tory tract and in the lung-associated lymph nodes. A electronics industry, the potential for worker exposure, spectrum of inflammatory and proliferative lesions gen- and the absence of chronic toxicity data. Male and erally occurred in the lungs of all exposed groups of female F344/N rats and B6C3F1 mice were exposed to rats and consisted of alveolar proteinosis, chronic indium phosphide (greater
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