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A Case-Study using in vitro DNT NAMs as part of a Weight-of-Evidence (WoE) approach to decision-making for DNT
Citation:
Shafer, T. A Case-Study using in vitro DNT NAMs as part of a Weight-of-Evidence (WoE) approach to decision-making for DNT. OECD WNT, Paris (online), FRANCE, May 11, 2022. https://doi.org/10.23645/epacomptox.21727874
Impact/Purpose:
Assessment of Developmental Neurotoxicity (DNT) using animal-based Guideline studies is expensive, time consuming, and does not always yield actionable data. Further, DNT assessment is not required under TSCA and the Guideline DNT study is a triggered study under FIFRA. Consequently, few of the tens of thousands of chemicals to which humans may be exposed have been evaluated for DNT hazard. To address this issue, New Approach Methodologies (NAMs) are being developed that can help provide data for risk decisions under FIFRA and TSCA. As these methods become more widely utilized, they can also provide information for other types of environmental decision-making as well. This presentation is a case-study of the use of NAMs approaches to make weight-of-evidence decisions regarding whether or not to request a guideline DNT study for a chemical under FIFRA.
Description:
Presentation to the Organisation for Economic Co-operation and Development (OECD) Working Group of National Coordinators of the Test Guidelines Programme (WNT) Meeting May 2022
URLs/Downloads:
DOI: A Case-Study using in vitro DNT NAMs as part of a Weight-of-Evidence (WoE) approach to decision-making for DNT
SHAFER_OECD WNT CASE STUDY.PDF (PDF, NA pp, 736.129 KB, about PDF)