New approach methodologies (NAMs) to support regulatory assessment of developmental immunotoxicity - a new PARC project
Smith, Nicola M de Bruijn, Véronique MP Vandebriel, Rob J Hargitai, Rita Lumniczky, Katalin Janssen, Aafke WF Beekmann, Karsten Usta, Birol Tigges, Julia Spruck, Christiane
Smith, Nicola M
de Bruijn, Véronique MP
Vandebriel, Rob J
Hargitai, Rita
Lumniczky, Katalin
Janssen, Aafke WF
Beekmann, Karsten
Usta, Birol
Tigges, Julia
Spruck, Christiane
Series / Report no.
Open Access
Type
Journal Article
Review
Article
Review
Article
Language
en
Date of publication
2026-04-17
Year of publication
Research Projects
Organizational Units
Journal Issue
Title
New approach methodologies (NAMs) to support regulatory assessment of developmental immunotoxicity - a new PARC project
Translated Title
Published in
Front Toxicol 2026; 8:1740390
Abstract
The current testing strategy for the assessment of developmental immunotoxicity (DIT) in European chemicals regulations has well recognised limitations. In response to these limitations, the Partnership for the Assessment of Risks from Chemicals (PARC) initiated a 4-year DIT project in May 2025. This project comprises 14 partner institutions and will tackle two primary objectives: a) to enhance the DIT knowledgebase and refine the understanding of critical phases of immune system development, and b) to facilitate the transition towards the use of New Approach Methodologies (NAMs) in DIT risk assessment. The first objective will be approached by reviews of existing literature and the continued advancement of a physiological map of human immune system development. The reviews and the physiological map will in turn serve as foundational tools to support NAMs and Adverse Outcome Pathway (AOP) development. Addressing the second objective, the project has a short-term aim to promote a testing strategy that leverages current immunotoxicity assays and their modifications to inform regulatory decision processes such as screening, prioritisation and read-across analyses. In the longer term, novel NAMs, encompassing developmental processes, will be developed and assessed for their regulatory applicability. While the primary focus of this PARC project is on the enhancement of human DIT risk assessment, it also aims to contribute to the advancement of ecotoxicological evaluation of immunotoxicity.