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TR-561: Tetralin (CASRN 119-64-2) in F344/N Rats and B6C3F1 Mice

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TR-561: Tetralin (CASRN 119-64-2) in F344/N Rats and B6C3F1 Mice NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF TETRALIN (CAS NO. 119-64-2) IN F344/N RATS AND B6C3F1 MICE AND A TOXICOLOGY STUDY OF TETRALIN IN MALE NBR RATS (INHALATION STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 April 2011 NTP TR 561 NIH Publication No. 11-5902 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 TETRALIN (CAS NO. 119-64-2) IN F344/N RATS AND B6C3F1 MICE AND A TOXICOLOGY STUDY OF TETRALIN IN MALE NBR RATS (INHALATION STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 April 2011 NTP TR 561 NIH Publication No. 11-5902 National Institutes of Health Public Health Service U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 2 CONTRIBUTORS National Toxicology Program R.O.W. Sciences, Inc. Evaluated and interpreted results and reported findings Provided SMVCE analysis P.C. Chan, Ph.D., Study Scientist G.W. Wolfe, Ph.D., Principal Investigator R.A. Herbert, D.V.M., Ph.D., Study Pathologist Y. Wang, M.S. J.B. Bishop, Ph.D. D.W. Bristol, Ph.D. Dynamac Corporation J.R. Bucher, Ph.D. Prepared quality assessment audits R.S. Chhabra, Ph.D. S. Brecher, Ph.D., Principal Investigator P.M. Foster, Ph.D. S. Iyer, B.S. M.J. Hooth, Ph.D. V.S. Tharakan, D.V.M. A.P. King-Herbert, D.V.M. G.E. Kissling, Ph.D. NTP Pathology Working Group D.E. Malarkey, D.V.M., Ph.D. Evaluated slides and contributed to pathology report on rats J.H. Roycroft, Ph.D. (November 1, 2007) C.S. Smith, Ph.D. W.G. Lieuallen, D.V.M., Ph.D., Coordinator G.S. Travlos, D.V.M. Pathology Associates International, A Charles River Company S. Waidyanatha, Ph.D. S.A. Elmore, D.V.M., M.S. N.J. Walker, Ph.D. National Toxicology Program K.L. Witt, M.S. R.A. Herbert, D.V.M., Ph.D. National Toxicology Program Battelle Toxicology Northwest W.O. Iverson, D.V.M. Experimental Pathology Laboratories, Inc. Conducted studies and evaluated pathology findings H.M. Kolenda-Roberts, D.V.M., Ph.D. B.J. Chou, D.V.M., Ph.D., Principal Investigator Experimental Pathology Laboratories, Inc. (2-week and 3-month studies) R.A. Miller, D.V.M., Ph.D. J.A. Dill, Ph.D., Principal Investigator (2-year studies) Experimental Pathology Laboratories, Inc. S.L. Grumbein, D.V.M., Ph.D. J.C. Peckham, D.V.M., M.S., Ph.D. B.K. Hayden Experimental Pathology Laboratories, Inc. R.A. Miller, D.V.M., Ph.D. B.P. Singh, B.V.Sc., M.S. R.A. Renne, D.V.M. National Toxicology Program R.B. Wastenberg, Ph.D. Experimental Pathology Laboratories, Inc. Provided pathology review M.H. Hamlin, II, D.V.M., Principal Investigator W.O. Iverson, D.V.M. H.M. Kolenda-Roberts, D.V.M., Ph.D. R.A. Miller, D.V.M., Ph.D. J.C. Peckham, D.V.M., M.S., Ph.D. 3 NTP Pathology Working Group SRA International, Inc. Evaluated slides and contributed to pathology report on mice Provided statistical analyses (November 1, 2007) P.W. Crockett, Ph.D., Principal Investigator L.H. Brennecke, D.V.M., Coordinator L.J. Betz, M.S. Pathology Associates International, A Charles River Company K.P. McGowan, M.B.A. S.A. Elmore, D.V.M., M.S. National Toxicology Program R.A. Herbert, D.V.M., Ph.D. Biotechnical Services, Inc. National Toxicology Program Prepared Technical Report W.O. Iverson, D.V.M. S.R. Gunnels, M.A., Principal Investigator Experimental Pathology Laboratories, Inc. L.M. Harper, B.S. H.M. Kolenda-Roberts, D.V.M., Ph.D. D.C. Serbus, Ph.D. Experimental Pathology Laboratories, Inc. G.E. Simmons, M.A. R.A. Miller, D.V.M., Ph.D. Experimental Pathology Laboratories, Inc. J.C. Peckham, D.V.M., M.S., Ph.D. Experimental Pathology Laboratories, Inc. B.P. Singh, B.V.Sc., M.S. National Toxicology Program 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 . 21 RESULTS . 35 DISCUSSION AND CONCLUSIONS . 65 REFERENCES . 71 APPENDIX A Summary of Lesions in Male Rats in the 2-Year Inhalation Study of Tetralin . 77 APPENDIX B Summary of Lesions in Female Rats in the 2-Year Inhalation Study of Tetralin . 93 APPENDIX C Summary of Lesions in Male Mice in the 2-Year Inhalation Study of Tetralin . 109 APPENDIX D Summary of Lesions in Female Mice in the 2-Year Inhalation Study of Tetralin . 121 APPENDIX E Genetic Toxicology . 133 APPENDIX F Clinical Pathology Results . 139 APPENDIX G Renal Toxicity, Urinalysis, and Urinary Metabolite Results . 147 APPENDIX H Organ Weights and Organ-Weight-to-Body-Weight Ratios . 155 APPENDIX I Reproductive Tissue Evaluations and Estrous Cycle Characterization . 161 APPENDIX J Chemical Characterization and Generation of Chamber Concentrations . 165 APPENDIX K Ingredients, Nutrient Composition, and Contaminant Levels in NTP-2000 Rat and Mouse Ration . 177 APPENDIX L Sentinel Animal Program . 181 APPENDIX M Single Dose Toxicokinetic Studies in F344/N Rats and B6C3F1 Mice . 185 5 Summary Background Tetralin is widely used as a solvent for naphthalene, waxes, resins, oils, fats, polishes, and cleaning products. We studied tetralin to determine if it caused cancer in rats or mice. methods We exposed groups of 50 male and female rats and mice to air containing 30, 60, or 120 parts per million (ppm) tetralin six hours per day for two years. Similar groups of 50 animals were exposed to clean air in the same inhalation chambers six hours per day as the untreated control groups. Tissues from more than 40 sites were examined for every animal. results Survival and body weights of rats and mice were not adversely affected by exposure to tetralin. Male rats exposed to tetralin had higher rates of tumors of the kidney, and female rats exposed to decalin had increased rates of rare tumors in the liver and polyps in the uterus. There were also slightly increased rates of testicular tumors in male rats and hemangiosarcomas of the spleen in female mice. In all groups of male and female rats and mice exposed to tetralin by inhalation there was extensive hyperplasia and metaplasia of the epithelium of the nose. All male and female mice exposed to tetralin had granules in the urinary bladder. Conclusions We conclude that tetralin caused cancer of the kidney in male rats and of the liver and uterus in female rats. Increases in testicular tumors in male rats and hemangiosarcomas of the spleen in female mice may have been related to exposure to tetralin. There was no evidence that tetralin increased tumor rates in male mice. Noncancerous lesions in the nose in all groups of exposed animals and of the urinary bladder in all exposed mice were attributed to exposure to tetralin. 6 7 ABSTRACT TETRALIN CAS No. 119-64-2 Chemical Formula: C10H12 Molecular Weight: 132.21 Synonyms: Benzocyclohexane; )5,7,9-naphthalene; naphthalene 1,2,3,4-tetrahydride; tetrahydronaphthalene; 1,2,3,4-tetrahydronaphthalene; tetraline Trade name: Tetranap Tetralin is used as an industrial solvent primarily for were included to study the relationship of "2u-globulin naphthalene, fats, resins, oils, and waxes; as a solvent and renal lesion induction.
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