Recommendations for harmonization of data collection and analysis of developmental neurotoxicity endpoints in regulatory guideline studies: Proceedings of workshops presented at Society of Toxicology and joint Teratology Society and Neurobehavioral Teratology Society meetings

Publication date: Available online 27 July 2017 Source:Neurotoxicology and Teratology Author(s): Abby A. Li, Larry P. Sheets, Kathleen Raffaele, Virginia Moser, Angela Hofstra, Alan Hoberman, Susan L. Makris, Robert Garman, Brad Bolon, Wolfgang Kaufmann, Roland Auer, Edmund Lau, Thomas Vidmar, Wayne J. Bowers The potential for developmental neurotoxicity (DNT) of environmental chemicals may be evaluated using specific test guidelines from the US Environmental Protection Agency or the Organisation for Economic Cooperation and Development (OECD). These guidelines generate neurobehavioral, neuropathological, and morphometric data that are evaluated by regulatory agencies globally. Data from these DNT guideline studies, or the more recent OECD extended one-generation reproductive toxicity guideline, play a pivotal role in children's health risk assessment in different world areas. Data from the same study may be interpreted differently by regulatory authorities in different countries resulting in inconsistent evaluations that may lead to inconsistencies in risk assessment decisions internationally, resulting in regional differences in public health protection or in commercial trade barriers. These issues of data interpretation and reporting are also relevant to juvenile and pre-postnatal studies conducted more routinely for pharmaceuticals and veterinary medicines. There is a need for development of recommendations geared toward the operational needs of the regula...
Source: Neurotoxicology and Teratology - Category: Toxicology Source Type: research