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Development and Use of New Approach Methodologies for Developmental Neurotoxicity Hazard.
Citation:
Shafer, T. Development and Use of New Approach Methodologies for Developmental Neurotoxicity Hazard. Triangle Society for Neuroscience, RTP, NC, September 09, 2022. https://doi.org/10.23645/epacomptox.21111172
Impact/Purpose:
Presentation to the Triangle Society for Neuroscience September 2022. 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.
Description:
Developmental neurotoxicity (DNT) hazard information is lacking for tens of thousands of chemicals that are present in the environment, which hinders regulatory evaluation of exposure risks for developing individuals. Because guideline DNT studies are expensive and slow, obtaining DNT hazard information with in vivo approaches for these chemicals is not feasible. To address this issue, new approach methodologies have been developed over the last 15 years that assess the effects of chemicals on key neurodevelopmental processes including proliferation, apoptosis, neurite outgrowth, synaptogenesis and network formation. A battery of these assays is now being used to evaluate sets of chemicals for DNT hazard, and some data is being used to inform decision-making on environmental chemicals including pesticides and PFAS compounds. Finally, the Organization of Economic Cooperation and Development is supporting the development of a guidance document to aid regulatory decision-makers in the use of data from these assays. This presentation will discuss how these assays were developed and evaluated, provide examples of how the data from these assays are being used to impact decision-making, and discuss the limitations and future needs for the use of NAMs in DNT hazard identification. (This abstract does not reflect EPA Policy).
URLs/Downloads:
DOI: Development and Use of New Approach Methodologies for Developmental Neurotoxicity Hazard.
SHAFER_TRIANGLE SFN 2022V2.PDF (PDF, NA pp, 2987.086 KB, about PDF)