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Isobutyraldehyde

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Isobutyraldehyde NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF ISOBUTYRALDEHYDE (CAS NO. 78-84-2) IN F344/N RATS AND B6C3F1 MICE (INHALATION STUDIES) February 1999 NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 NTP TR 472 NIH Publication No. 99-3962 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 ISOBUTYRALDEHYDE (CAS NO. 78-84-2) IN F344/N RATS AND B6C3F1 MICE (INHALATION STUDIES) February 1999 NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 NTP TR 472 NIH Publication No. 99-3962 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health 2 Isobutyraldehyde, NTP TR 472 CONTRIBUTORS National Toxicology Program NTP Pathology Working Group Evaluated and interpreted results and reported findings Evaluated slides, prepared pathology report on rats (29 May 1996) K.M. Abdo, Ph.D., Study Scientist D.G. Goodman, V.M.D., Chairperson D.A. Bridge, B.S. PATHCO, Inc. J.R. Bucher, Ph.D. D. Banas, D.V.M., M.S. R.E. Chapin, Ph.D. Experimental Pathology Laboratories, Inc. J.R. Hailey, D.V.M. J.R. Hailey, D.V.M. J.K. Haseman, Ph.D. National Toxicology Program R.R. Maronpot, D.V.M. R.A. Herbert, D.V.M., Ph.D. A. Nyska, D.V.M. National Toxicology Program G.N. Rao, D.V.M., Ph.D. P. Little, D.V.M., M.S., Ph.D. Pathology Associates International J.H. Roycroft, Ph.D. A. Nyska, D.V.M. C.S. Smith, Ph.D. National Toxicology Program G.S. Travlos, D.V.M. A. Radovsky, D.V.M., Ph.D. D.B. Walters, Ph.D. National Toxicology Program K.L. Witt, M.S., Oak Ridge Associated Universities D. Wolf, D.V.M., Ph.D. Chemical Industry Institute of Toxicology Litton Bionetics, Inc. Evaluated slides, prepared pathology report on mice Conducted 13-week studies, evaluated pathology findings (23 July 1996) B.J. Chou, D.V.M., Ph.D., Principal Investigator L. Lanning, D.V.M., Chairperson D. Craig, Ph.D. Pathology Associates International J.M. Fitzgerald, Ph.D. S. Botts, D.V.M., M.S., Ph.D. A.G. Manus, D.V.M. Experimental Pathology Laboratories, Inc. J.R. Hailey, D.V.M. National Toxicology Program Battelle Pacific Northwest Laboratories R.A. Herbert, D.V.M., Ph.D. Conducted 2-year studies, evaluated pathology findings National Toxicology Program J.R. Leininger, D.V.M., Ph.D. Principal Investigator B.J. Chou, D.V.M., Ph.D., National Toxicology Program A.W. Gieschen, B.S. C. Merrill, D.V.M., Observer S.L. Grumbein, D.V.M., Ph.D. North Carolina State University T.J. Mast, Ph.D. A. Nyska, D.V.M. R.A. Renne, D.V.M., Ph.D. National Toxicology Program A. Radovsky, D.V.M., Ph.D. National Toxicology Program Experimental Pathology Laboratories, Inc. D. Wolf, D.V.M., Ph.D. Provided pathology quality assurance Chemical Industry Institute of Toxicology J.F. Hardisty, D.V.M., Principal Investigator D. Banas, D.V.M., M.S. Dynamac Corporation S. Botts, D.V.M., M.S., Ph.D. Prepared quality assurance audits S. Brecher, Ph.D., Principal Investigator Isobutyraldehyde, NTP TR 472 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. J.M. Gregory, B.S. N.G. Mintz, B.S. L.M. Harper, B.S. A.M. Macri-Hanson, M.A., M.F.A. S.M. Swift, B.S. 4 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 ................................................ 17 RESULTS ............................................................... 27 DISCUSSION AND CONCLUSIONS ............................................ 47 REFERENCES ........................................................... 51 APPENDIX A Summary of Lesions in Male Rats in the 2-Year Inhalation Study of Isobutyraldehyde ............................................. 57 APPENDIX B Summary of Lesions in Female Rats in the 2-Year Inhalation Study of Isobutyraldehyde ............................................. 89 APPENDIX C Summary of Lesions in Male Mice in the 2-Year Inhalation Study of Isobutyraldehyde ............................................. 119 APPENDIX D Summary of Lesions in Female Mice in the 2-Year Inhalation Study of Isobutyraldehyde ............................................. 151 APPENDIX E Genetic Toxicology ............................................. 187 APPENDIX F Organ Weights and Organ-Weight-to-Body-Weight Ratios .................. 207 APPENDIX G Hematology and Clinical Chemistry Results ............................. 211 APPENDIX H Reproductive Tissue Evaluations and Estrous Cycle Characterization ........... 215 APPENDIX I Chemical Characterization and Generation of Chamber Concentrations ......... 219 APPENDIX J Ingredients, Nutrient Composition, and Contaminant Levels in NIH-07 Rat and Mouse Ration ................................... 231 APPENDIX K Sentinel Animal Program ......................................... 235 5 ABSTRACT O CH3 CH CH CH3 ISOBUTYRALDEHYDE CAS No. 78-84-2 Chemical Formula: C4 H 8 O Molecular Weight: 72.10 Synonyms: Dimethylacetaldehyde; 2-formylpropane; isobutanal; isobutylcarboxaldehyde; isobutyral; isobutyric aldehyde; isobutyrylaldehyde; isopropylformaldehyde; 2-methylpropanal; 2-methyl-1-propanal; "-methylpropionaldehyde; 2-methylpropionaldehyde; valine aldehyde Isobutyraldehyde, a branched alkyl aldehyde, is used melanogaster germ cells and bone marrow cells of as a chemical intermediate and flavoring agent. It was rats and mice. nominated by the National Cancer Institute for toxicity and carcinogenicity studies by the NTP. Reasons for nomination and selection of isobutyraldehyde for study included its high potential for human exposure 13-WEEK STUDY IN RATS as suggested by its high production volume, its use as Groups of 10 male and 10 female F344/N rats were a chemical intermediate and food flavoring agent, exposed to 0, 500, 1,000, 2,000, 4,000, or 8,000 ppm suspicion of carcinogenicity due to an increased isobutyraldehyde by inhalation, 6 hours per day, incidence of cancer at an aldehyde manufacturing 5 days a week, for 13 weeks. All rats exposed to plant where workers were exposed to a variety of 8,000 ppm died before the end of the study. Three aldehydes, its structural relationship to formaldehyde male rats and six female rats in the 4,000 ppm groups (a nasal carcinogen in rats), and the lack of toxicity and one female in the 500 ppm group died before the and carcinogenicity studies on isobutyraldehyde in end of
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