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Ginseng (CASRN 50647-08-0) in F344/N Rats and B6C3F1 Mice

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Ginseng (CASRN 50647-08-0) in F344/N Rats and B6C3F1 Mice NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF GINSENG (CAS NO. 50647-08-0) IN F344/N RATS AND B6C3F1 MICE (GAVAGE STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 September 2011 NTP TR 567 NIH Publication No. 11-5909 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 GINSENG (CAS NO. 50647-08-0) IN F344/N RATS AND B6C3F1 MICE (GAVAGE STUDIES) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 September 2011 NTP TR 567 NIH Publication No. 11-5909 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 contributed to pathology report on 2-year rats (February 21, 2008) P.C. Chan, Ph.D., Study Scientist J.C. Peckham, D.V.M., M.S., Ph.D., Study Pathologist J.P. Morrison, D.V.M., Coordinator J.B. Bishop, Ph.D. Pathology Associates, A Division of Charles River Laboratories, Inc. J.R. Bucher, Ph.D. S.A. Elmore, D.V.M., M.S. R.S. Chhabra, Ph.D. National Toxicology Program P.M. Foster, Ph.D. G.P. Flake, M.D. R.A. Herbert, D.V.M., Ph.D. National Toxicology Program M.J. Hooth, Ph.D. R.A. Herbert, D.V.M., Ph.D. A.P. King-Herbert, D.V.M. National Toxicology Program G.E. Kissling, Ph.D. H.M. Kolenda-Roberts, D.V.M., Ph.D. D.E. Malarkey, D.V.M., Ph.D. Experimental Pathology Laboratories A. Nyska, D.V.M. A. Nyska, D.V.M. National Toxicology Program J.H. Roycroft, Ph.D. M.J. Ryan, D.V.M., Ph.D. C.S. Smith, Ph.D. Battelle Columbus Operations G.S. Travlos, D.V.M. B.P. Singh, D.V.M., M.S. S. Waidyanatha, Ph.D. National Toxicology Program N.J. Walker, Ph.D. A.J. Skowronek, D.V.M., Ph.D. K.L. Witt, M.S. Battelle Columbus Operations G.A.Willson., B.V.M.S. Battelle Columbus Operations Experimental Pathology Laboratories Conducted studies and evaluated pathology findings Evaluated slides and contributed to pathology report on 2-year mice (February 21, 2008) M.R. Hejtmancik, Ph.D., Principal Investigator A.J. Skowronek, D.V.M., Ph.D. W.G. Lieuallen, D.V.M., Ph.D., Coordinator D.T. Vasconcelos, D.V.M., M. Vet. Sci., Ph.D. Pathology Associates, A Division of Charles River Laboratories, Inc. Experimental Pathology Laboratories, Inc. S.A. Elmore, D.V.M., M.S. Provided pathology review National Toxicology Program G.P. Flake, M.D. M.H. Hamlin, II, D.V.M., Principal Investigator National Toxicology Program H.M. Kolenda-Roberts, D.V.M., Ph.D. R.A. Herbert, D.V.M., Ph.D. R.A. Miller, D.V.M., Ph.D. National Toxicology Program C.C. Shackelford, D.V.M., M.S., Ph.D. H.M. Kolenda-Roberts, D.V.M., Ph.D. Experimental Pathology Laboratories G.A.Willson, B.V.M.S. A. Nyska, D.V.M. National Toxicology Program R.O.W. Sciences, Inc. M.J. Ryan, D.V.M., Ph.D. Provided SMVCE analysis Battelle Columbus Operations B.P. Singh, D.V.M., M.S. G.W. Wolfe, Ph.D., Principal Investigator National Toxicology Program H.S. Seung, M.S. A.J. Skowronek, D.V.M., Ph.D. Battelle Columbus Operations Dynamac Corporation G.A. Willson., B.V.M.S. Prepared quality assessment audits Experimental Pathology Laboratories S. Brecher, Ph.D., Principal Investigator S. Iyer, B.S. V.S. Tharakan, D.V.M. Ginseng, NTP TR 567 3 SRA International, 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. B.F. Hall, M.S. K.P. McGowan, M.B.A. L.M. Harper, B.S. D.C. Serbus, Ph.D. 4 CONTENTS ABSTRACT ................................................................................................................................................................. 7 EXPLANATION OF LEVELS OF EVIDENCE OF CARCINOGENIC ACTIVITY ........................................ 10 TECHNICAL REPORTS REVIEW SUBCOMMITTEE ..................................................................................... 11 SUMMARY OF TECHNICAL REPORTS REVIEW SUBCOMMITTEE COMMENTS ................................ 12 INTRODUCTION ..................................................................................................................................................... 13 MATERIALS AND METHODS .............................................................................................................................. 23 RESULTS ................................................................................................................................................................... 33 DISCUSSION AND CONCLUSIONS ..................................................................................................................... 53 REFERENCES .......................................................................................................................................................... 55 APPENDIX A Summary of Lesions in Male Rats in the 2-Year Gavage Study of Ginseng ............................... 61 APPENDIX B Summary of Lesions in Female Rats in the 2-Year Gavage Study of Ginseng ........................... 73 APPENDIX C Summary of Lesions in Male Mice in the 2-Year Gavage Study of Ginseng .............................. 85 APPENDIX D Summary of Lesions in Female Mice in the 2-Year Gavage Study of Ginseng .......................... 97 APPENDIX E Genetic Toxicology ......................................................................................................................... 109 APPENDIX F Clinical Pathology Results ............................................................................................................. 115 APPENDIX G Organ Weights and Organ-Weight-to-Body-Weight Ratios ...................................................... 121 APPENDIX H Reproductive Tissue Evaluations and Estrous Cycle Characterization .................................... 127 APPENDIX I Chemical Characterization and Dose Formulation Studies ....................................................... 131 APPENDIX J Ingredients, Nutrient Composition, and Contaminant Levels in NTP-2000 Rat and Mouse Ration ............................................................................................ 143 APPENDIX K Sentinel Animal Program .............................................................................................................. 147 Ginseng, NTP TR 567 5 SUMMARY Background Ginseng root is widely used as an herbal remedy and dietary supplement. We studied the effects of ginseng root extract on rats and mice to identify potential toxic or cancer-related hazards. Methods We administered solutions containing extracts of ginseng root in methylcellulose through a tube directly into the stomach of male and female rats and mice five times a week for two years. Groups of 50 animals received 1,250, 2,500, or 5,000 milligrams of ginseng root extract per kilogram of body weight.
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