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DART-04: Prenatal Development Studies of Dimethylaminoethanol

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DART-04: Prenatal Development Studies of Dimethylaminoethanol NTP DEVELOPMEntAL And REprODUCTIVE TOXICITY TECHNICAL REPOrt ON THE PRENATAL DEVELOPMEnt STUDIES OF DIMETHYLAMINOETHANOL BITArtrATE (CASRN 5988-51-2) IN SprAGUE DAWLEY (Hsd:SprAGUE DAWLEY® SD®) RAts (GAVAGE STUDIES) NTP DART 04 JUNE 2020 NTP Developmental and Reproductive Toxicity Technical Report on the Prenatal Development Studies of Dimethylaminoethanol Bitartrate (CASRN 5988-51-2) in Sprague Dawley (Hsd:Sprague Dawley® SD®) Rats (Gavage Studies) DART Report 04 June 2020 National Toxicology Program Public Health Service U.S. Department of Health and Human Services ISSN: 2690-2052 Research Triangle Park, North Carolina, USA Dimethylaminoethanol Bitartrate, NTP DART 04 Foreword The National Toxicology Program (NTP), established in 1978, is an interagency program within the Public Health Service of the U.S. Department of Health and Human Services. Its activities are executed through a partnership of the National Institute for Occupational Safety and Health (part of the Centers for Disease Control and Prevention), the Food and Drug Administration (primarily at the National Center for Toxicological Research), and the National Institute of Environmental Health Sciences (part of the National Institutes of Health), where the program is administratively located. NTP offers a unique venue for the testing, research, and analysis of agents of concern to identify toxic and biological effects, provide information that strengthens the science base, and inform decisions by health regulatory and research agencies to safeguard public health. NTP also works to develop and apply new and improved methods and approaches that advance toxicology and better assess health effects from environmental exposures. The NTP Technical Report series for developmental and reproductive toxicity studies began in 2019. The studies described in this NTP Technical Report series (i.e., the NTP DART Report series) are designed and conducted to characterize and evaluate the developmental or reproductive toxicity of selected substances in laboratory animals. Substances (e.g., chemicals, physical agents, and mixtures) selected for NTP reproductive and developmental studies are chosen primarily on the basis of human exposure, level of commercial production, and chemical structure. The interpretive conclusions presented in NTP DART Reports are based only on the results of these NTP studies, and extrapolation of these results to other species, including characterization of hazards and risks to humans, requires analyses beyond the intent of these reports. Selection for study per se is not an indicator of a substance’s developmental or reproductive toxicity potential. NTP conducts its studies in compliance with its laboratory health and safety guidelines and the Food and Drug Administration Good Laboratory Practice Regulations and meets or exceeds 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 Laboratory Animals. Studies are subjected to retrospective quality assurance audits before they are presented for public review. Draft reports undergo external peer review before they are finalized and published. The NTP DART Reports are available free of charge on the NTP website and cataloged in PubMed, a free resource developed and maintained by the National Library of Medicine (part of the National Institutes of Health). Data for these studies are included in NTP’s Chemical Effects in Biological Systems database. For questions about the reports and studies, please email NTP or call 984-287-3211. ii Dimethylaminoethanol Bitartrate, NTP DART 04 Table of Contents Foreword ......................................................................................................................................... ii Tables ............................................................................................................................................. iv Figures..............................................................................................................................................v About This Report.......................................................................................................................... vi Explanation of Levels of Evidence for Developmental Toxicity .................................................. ix Peer Review .................................................................................................................................. xii Publication Details ....................................................................................................................... xiii Acknowledgments........................................................................................................................ xiii Abstract ........................................................................................................................................ xiv Dose Range-finding Prenatal Developmental Toxicity Study ................................................ xiv Prenatal Developmental Toxicity Study ................................................................................. xiv Conclusions ...............................................................................................................................xv Introduction ......................................................................................................................................1 Chemical and Physical Properties ...............................................................................................1 Production, Use, and Human Exposure ......................................................................................1 Regulatory Status ........................................................................................................................2 Absorption, Distribution, Metabolism, and Excretion ................................................................3 Experimental Animals .........................................................................................................3 Humans ................................................................................................................................4 Developmental and Reproductive Toxicity ................................................................................4 Experimental Animals .........................................................................................................4 Humans ................................................................................................................................5 General Toxicity..........................................................................................................................6 Experimental Animals .........................................................................................................6 Humans ................................................................................................................................6 Genetic Toxicity ..........................................................................................................................7 Study Rationale ...........................................................................................................................7 Materials and Methods .....................................................................................................................8 Overview of Prenatal Developmental Toxicity Study Designs ..................................................8 Procurement and Characterization ..............................................................................................9 Dimethylaminoethanol Bitartrate .........................................................................................9 Sterile Water for Irrigation .................................................................................................10 Preparation and Analysis of Dose Formulations .......................................................................10 Animal Source ...........................................................................................................................11 Animal Health Surveillance ......................................................................................................11 Animal Welfare .........................................................................................................................11 Experimental Design .................................................................................................................11 Dose Range-finding Study .................................................................................................12 Prenatal Developmental Toxicity Study ............................................................................12 Statistical Methods ....................................................................................................................16 iii Dimethylaminoethanol Bitartrate, NTP DART 04 Descriptive Statistics ..........................................................................................................16 Analysis of Maternal Parameters and Uterine Contents ....................................................16 Analysis of Incidences of Gross Pathology and Morphology Findings ............................17 Historical Control Data .............................................................................................................17 Quality Assurance Methods ......................................................................................................17
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