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Sodium Thioglycolate (Casrn 367-51-1) Administered Dermally to F344/N Rats and B6C3F1/N Mice

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Sodium Thioglycolate (Casrn 367-51-1) Administered Dermally to F344/N Rats and B6C3F1/N Mice NTP TECHNICAL REPORT ON THE OXICITY TUDIES OF T S SODIUM THIOGLYCOLATE (CASRN 367-51-1) ADMINISTERED DERMALLY TO F344/N RATS AND B6C3F1/N MICE NTP TOX 80 MAY 2016 NTP Technical Report on the Toxicity Studies of Sodium Thioglycolate (CASRN 367-51-1) Administered Dermally to F344/N Rats and B6C3F1/N Mice Toxicity Report 80 May 2016 National Toxicology Program Public Health Service U.S. Department of Health and Human Services ISSN: 2378-8992 Research Triangle Park, North Carolina, USA Sodium Thioglycolate, NTP TOX 80 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 Toxicity Study Report series began in 1991. The studies described in the Toxicity Study Report series are designed and conducted to characterize and evaluate the toxicologic potential of selected substances in laboratory animals (usually two species, rats and mice). Substances selected for NTP toxicity studies are chosen primarily on the basis of human exposure, level of production, and chemical structure. The interpretive conclusions presented in the Toxicity Study 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 toxic 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 Toxicity Study Reports are indexed in National Center for Biotechnology Information (NCBI) Bookshelf and are available free of charge electronically on the NTP website (http://ntp.niehs.nih.gov). ii Sodium Thioglycolate, NTP TOX 80 Table of Contents Foreword ......................................................................................................................................... ii Tables.............................................................................................................................................. iv Figures ............................................................................................................................................ iv About This Report.......................................................................................................................... vi Peer Review ................................................................................................................................. viii Publication Details ......................................................................................................................... ix Abstract ............................................................................................................................................x Introduction ......................................................................................................................................1 Chemical and Physical Properties ...............................................................................................1 Production, Use, and Human Exposure ......................................................................................1 Regulatory Status ........................................................................................................................2 Absorption, Distribution, Metabolism, and Excretion ................................................................2 Toxicity .......................................................................................................................................3 Reproductive and Developmental Toxicity ................................................................................5 Carcinogenicity ...........................................................................................................................6 Genetic Toxicity ..........................................................................................................................6 Study Rationale ...........................................................................................................................6 Materials and Methods .....................................................................................................................7 Procurement and Characterization ..............................................................................................7 Preparation and Analysis of Dose Formulations .........................................................................7 Two-week Studies .......................................................................................................................8 Three-month Studies ...................................................................................................................9 Statistical Methods ....................................................................................................................13 Quality Assurance Methods ......................................................................................................14 Genetic Toxicology ...................................................................................................................14 Results ............................................................................................................................................16 Rats ............................................................................................................................................16 Mice...........................................................................................................................................21 Genetic Toxicology ...................................................................................................................25 Discussion ......................................................................................................................................28 References ......................................................................................................................................30 Appendix A. Summary of Neoplasms and Nonneoplastic Lesions in Rats and Mice ................ A-1 Appendix B. Genetic Toxicology ................................................................................................B-1 Appendix C. Clinical Pathology Results .....................................................................................C-1 Appendix D. Organ Weights and Organ-Weight-to-Body-Weight Ratios ................................. D-1 iii Sodium Thioglycolate, NTP TOX 80 Appendix E. Reproductive Tissue Evaluations and Estrous Cycle Characterization .................. E-1 Appendix F. Chemical Characterization and Dose Formulation Studies .................................... F-1 Appendix G. Feed Consumption................................................................................................. G-1 Appendix H. Ingredients, Nutrient Composition, and Contaminant Levels in NTP-2000 Rat and Mouse Ration ........................................................................................... H-1 Appendix I. Sentinel Animal Program .......................................................................................... I-1 Tables Table 1. Experimental Design and Materials and Methods in the Dermal Studies of Sodium Thioglycolate .....................................................................................................10 Table 2. Survival and Body Weights of Rats in the Two-week Dermal Study of Sodium Thioglycolate ...................................................................................................................16 Table 3. Selected Organ Weights and Organ-Weight-to-Body-Weight Ratios for Male Rats in the Two-week Dermal Study of Sodium Thioglycolate ......................................17 Table 4. Survival and Body Weights of Rats in the Three-month Dermal Study of Sodium Thioglycolate ...................................................................................................................18 Table 5. Incidences of Nonneoplastic Lesions of the Skin at the Site of Application in Rats in the Three-month Dermal Study of Sodium Thioglycolate ..................................20 Table 6. Survival and Body Weights of Mice in the Two-week Dermal Study of Sodium Thioglycolate ...................................................................................................................21
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