NAM4NT – Potential of New Approach Methods to Delineate Between Developmental and Adult Neurotoxicity Hazard
Neurotoxicity is increasingly recognized as a key challenge in chemical safety assessment. Under the CLP Regulation, there is currently no dedicated hazard class for neurotoxicity. Adult neurotoxicity (ANT) is addressed within Specific Target Organ Toxicity (STOT), while developmental neurotoxicity (DNT) is considered under reproductive toxicity, without being explicitly defined as a separate endpoint. This regulatory structure does not fully reflect current scientific understanding of how chemicals can affect the nervous system across different life stages. With the rapid progress of New Approach Methodologies (NAMs), new opportunities have emerged for mechanistic and human-relevant assessment of neurotoxicity.
At the request of the European Chemicals Agency (ECHA), the NAM4NT project was established within PARC to evaluate whether available NAMs can reliably detect ANT and DNT hazards and, crucially, whether they can delineate between these two endpoints.
NAM4NT will consolidate existing mechanistic knowledge, integrate available NAM data, and critically assess biological commonalities and differences between developmental and adult neurotoxicity. Where evidence is insufficient, targeted case studies will be used to address key uncertainties. The overarching goal is to determine whether neurotoxicity should be considered as a single hazard class or subdivided into ANT and DNT categories. By providing a clear scientific rationale for NAM-based neurotoxicity assessment, NAM4NT aims to support future regulatory discussions under CLP and contribute to a modern, mechanism-based framework for chemical hazard classification in Europe.
Project Manager:
Dr. Jonathan Blum (University of Basel - UNIBAS, Switzerland)
Deputy Project Managers:
Prof. Tamara Tal (Helmholtz Centre for Environmental Research – UFZ, Germany)
Prof. Ellen Fritsche (University of Basel - UNIBAS, Switzerland)