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TR-553: Photococarcinogenesis Study of Aloe Vera[CASRN 481-72-1

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TR-553: Photococarcinogenesis Study of Aloe Vera[CASRN 481-72-1 NTP TECHNICAL REPORT ON THE PHOTOCOCARCINOGENESIS STUDY OF ALOE VERA [CAS NO. 481-72-1 (Aloe-emodin)] IN SKH-1 MICE (SIMULATED SOLAR LIGHT AND TOPICAL APPLICATION STUDY) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 September 2010 NTP TR 553 NIH Publication No. 10-5894 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 PHOTOCOCARCINOGENESIS STUDY OF ALOE VERA [CAS NO. 481-72-1 (Aloe-emodin)] IN SKH-1 MICE (SIMULATED SOLAR LIGHT AND TOPICAL APPLICATION STUDY) NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 September 2010 NTP TR 553 NIH Publication No. 10-5894 National Institutes of Health Public Health Service U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 2 CONTRIBUTORS The photococarcinogenesis study of Aloe vera was conducted at the Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR) under an interagency agreement between the FDA and the National Institute of Environmental Health Sciences (NIEHS). The studies were monitored by a Toxicology Study Selection and Review Committee composed of representatives from the NCTR and other FDA centers, NIEHS, and other ad hoc members from other governmental agencies and academia. The interagency agreement was designed to use the staff and facilities of the NCTR in the testing of FDA priority chemicals and to provide FDA scientists and regulatory policymakers with information for hazard identification and risk assessment. Toxicology Study Selection Toxicology Study Selection and Review Committee and Review Committee (continued) W.T. Allaben, Ph.D. L.M. Katz, M.D., Ph.D. National Center for Toxicological Research, Center for Food Safety and Applied Nutrition, Food and Drug Administration Food and Drug Administration F.A. Beland, Ph.D. D. Levy, Ph.D. National Center for Toxicological Research, Center for Food Safety and Applied Nutrition, Food and Drug Administration Food and Drug Administration R.L. Bronaugh, Ph.D. R.J. Lorentzen, Ph.D. Center for Food Safety and Applied Nutrition, Center for Food Safety and Applied Nutrition, Food and Drug Administration Food and Drug Administration J.R. Bucher, Ph.D. M. Miller, Ph.D. National Institute of Environmental Health Sciences National Center for Toxicological Research, J.K. Dunnick, Ph.D. Food and Drug Administration National Institute of Environmental Health Sciences L.S. Pellicore, Ph.D. P.D. Forbes, Ph.D. Center for Food Safety and Applied Nutrition, Charles River Laboratories, Inc. Food and Drug Administration P.M. Foster, Ph.D. M.C. Poirier, Ph.D. National Institute of Environmental Health Sciences National Cancer Institute B. Frankos, Ph.D. W.T. Slikker, Ph.D. Center for Food Safety and Applied Nutrition, National Center for Toxicological Research, Food and Drug Administration Food and Drug Administration J.P. Hanig, Ph.D. L.M. Tarantino, Ph.D. Center for Drug Evaluation and Research, Center for Food Safety and Applied Nutrition, Food and Drug Administration Food and Drug Administration S.H. Henry, Ph.D. A.M. Turzillo, D.V.M. Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, Food and Drug Administration Food and Drug Administration P.C. Howard, Ph.D. N.J. Walker, Ph.D. National Center for Toxicological Research, National Institute of Environmental Health Sciences Food and Drug Administration V.E. Walker, Ph.D. A.C. Jacobs, Ph.D. Lovelace Respiratory Institute Center for Drug Evaluation and Research, W.G. Wamer, Ph.D. Food and Drug Administration Center for Food Safety and Applied Nutrition, Food and Drug Administration 3 National Center for Toxicological Research, NTP Pathology Working Group Food and Drug Administration Evaluated slides and contributed to pathology reports Conducted study, evaluated and interpreted results and (May 25-26, 2006) pathology findings, and reported findings C.C. Shackelford, D.V.M., M.S., Ph.D., Coordinator M.D. Boudreau, Ph.D., Study Scientist Experimental Pathology Laboratories, Inc. F.A. Beland, Ph.D. C.H. Frith, D.V.M., Ph.D. B.R. Brown, B.S. Toxicologic Pathology Associates P.C. Howard, Ph.D. J.F. Hardisty, D.V.M. B.J. Miller, M.S. Experimental Pathology Laboratories, Inc. T.C. Schmitt, B.S. J.R. Latendresse, D.V.M., Ph.D. P.H. Siitonen, B.S. National Center for Toxicological Research P.J. Webb, B.S. D.E. Malarkey, D.V.M., Ph.D. National Institute of Environmental Health Sciences Conducted quality assessment audits R.A. Miller, D.V.M., Ph.D. S.J. Culp, Ph.D. Experimental Pathology Laboratories, Inc. J.M. Fowler, B.S. P.W. Mellick, D.V.M., Ph.D. Y.E. Whiteside, B.S. National Center for Toxicological Research G.R. Olson, D.V.M., Ph.D. Bionetics National Center for Toxicological Research Prepared animal feed and cared for mice Z-Tech Corp. J. Carson, B.S. L. Conner Provided statistical analyses and software systems development A. Matson, B.S. K.A. Carroll M. Nichols S. Goldman S.H. Green Toxicologic Pathology Associates W.A. McCracken, M.S. Evaluated pathology findings B.T. Thorn, M.S. J. Wulff, M.S. P.W. Mellick, D.V.M., Ph.D. G.R. Olson, D.V.M., Ph.D. Biotechnical Services, Inc. A. Warbritton L. Wiley, B.S. Prepared Technical Report S.R. Gunnels, M.A., Principal Investigator Experimental Pathology Laboratories, Inc. B.F. Hall, M.S. Provided pathology review L.M. Harper, B.S. D.C. Serbus, Ph.D. M.H. Hamlin, II, D.V.M., Principal Investigator G.E. Simmons, M.A. J.F. Hardisty, D.V.M. R.A. Miller, D.V.M., Ph.D. C.C. Shackelford, D.V.M., M.S., Ph.D. 4 CONTENTS ABSTRACT . 7 TECHNICAL REPORTS REVIEW SUBCOMMITTEE . 11 SUMMARY OF TECHNICAL REPORTS REVIEW SUBCOMMITTEE COMMENTS . 12 INTRODUCTION . 15 MATERIALS AND METHODS . 25 RESULTS . 35 DISCUSSION AND CONCLUSIONS . 99 REFERENCES . 105 APPENDIX A Summary of Lesions in Male Mice in the 1-Year Simulated Solar Light Study of Aloe vera . 111 APPENDIX B Summary of Lesions in Female Mice in the 1-Year Simulated Solar Light Study of Aloe vera . 129 APPENDIX C Body Weight Data . 149 APPENDIX D Chemical Characterization and Dose Formulation Studies . 163 APPENDIX E Spectral Irradiance of the Simulated Solar Light . 179 APPENDIX F Dosimetry of the Simulated Solar Light . 191 APPENDIX G Ingredients, Nutrient Composition, and Contaminant Levels in NIH-31 Rat and Mouse Ration . 195 APPENDIX H Sentinel Animal Program . 199 APPENDIX I Ingredient Use Data for Aloe Barbadensis Leaf, Aloe Barbadensis Leaf Extract, and Aloe Barbadensis Leaf Juice . 201 Aloe vera, NTP TR 553 5 SUMMARY Background Extracts from the Aloe vera plant are widely used in skin care products. We studied the effects of synthetic solar light on the skin of hairless mice that had been treated with creams containing various Aloe vera extracts. Methods We applied creams containing Aloe vera plant extracts (aloe gel, whole leaf, or decolorized whole leaf) or aloe- emodin to groups of 36 male and female hairless mice in the morning; other groups received creams containing no aloe. In the afternoon groups of animals were exposed to synthetic solar light for four hours. Other groups were not exposed to light and were control groups. The treatments and exposures were performed five days per week for 40 weeks, during which the animals were monitored for development of skin cancers. Results Mice exposed to synthetic solar light developed significant increases in squamous cell neoplasms and squamous cell nonneoplastic lesions of the skin whether or not they received treatment with cream.
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