European stakeholders' workshop on new approach methodologies (NAMs) for developmental neurotoxicity (DNT) and their use in the regulatory risk assessment of chemicals

Abstract

Characterization of potential chemical-induced developmental neurotoxicity (DNT) hazard is considered for risk assessment purposes by many regulatory sectors. To address challenging endpoints such as DNT, EFSA, in collaboration with the Organisation for Economic Co-Operation and Development (OECD), the Danish EPA and the US EPA, has been working toward the development of integrated approaches for testing and assessment (IATA) that rely on a combination of multiple layers of data (e.g. in vitro, in silico and non-mammalian in vivo models) that are supported by mechanistic knowledge organized according to the adverse outcome pathway (AOP) framework. This international effort culminated in the development of an OECD guidance on the use and interpretation of NAMs for DNT; this guidance is currently in an advanced draft status along the OECD process for approval and publication. This workshop was organized by EFSA to update European stakeholders on the progress and receive comments thereof. The workshop provided an overview of this international effort and represented an opportunity to discuss the current DNT testing paradigm and the regulatory hurdles for the implementation of DNT testing of chemicals by incorporation of a mechanistic understanding and inclusion in the regulatory process.