TY - JOUR
T1 - New approach methodologies (NAMs) to support regulatory assessment of developmental immunotoxicity – a new PARC project
AU - Smith, Nicola M.
AU - de Bruijn, Véronique M.P.
AU - Vandebriel, Rob J.
AU - Hargitai, Rita
AU - Lumniczky, Katalin
AU - Janssen, Aafke W.F.
AU - Beekmann, Karsten
AU - Usta, Birol
AU - Tigges, Julia
AU - Spruck, Christiane
AU - Hurem, Selma
AU - Iulini, Martina
AU - Corsini, Emanuela
AU - Bado-Nilles, Anne
AU - Beaudouin, Rémy
AU - Katsiadaki, Ioanna
AU - Cano, Irene
AU - Sebire, Marion
AU - Ayuk, Humblenoble Stembridge
AU - Stojanovska, Violeta
AU - Zenclussen, Ana C.
AU - Blanc, Etienne B.
AU - Kerdine-Römer, Saadia
AU - Lacerda, Rafaela
AU - Romão, Luísa
AU - Monfort-Lanzas, Pablo
AU - Gostner, Johanna M.
AU - Mposhi, Archibold
AU - Turner, Jonathan D.
AU - Del Favero, Giorgia
AU - Lindeman, Birgitte
N1 - Publisher Copyright:
Copyright © 2026 Smith, de Bruijn, Vandebriel, Hargitai, Lumniczky, Janssen, Beekmann, Usta, Tigges, Spruck, Hurem, Iulini, Corsini, Bado-Nilles, Beaudouin, Katsiadaki, Cano, Sebire, Ayuk, Stojanovska, Zenclussen, Blanc, Kerdine-Römer, Lacerda, Romão, Monfort-Lanzas, Gostner, Mposhi, Turner, Del Favero and Lindeman.
Copyright © 2026 Smith, de Bruijn, Vandebriel, Hargitai, Lumniczky, Janssen, Beekmann, Usta, Tigges, Spruck, Hurem, Iulini, Corsini, Bado-Nilles, Beaudouin, Katsiadaki, Cano, Sebire, Ayuk, Stojanovska, Zenclussen, Blanc, Kerdine-Römer, Lacerda, Romão, Monfort-Lanzas, Gostner, Mposhi, Turner, Del Favero and Lindeman.
PY - 2026/4/17
Y1 - 2026/4/17
N2 - 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.
AB - 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.
KW - PARC
KW - developmental immunotoxicity
KW - environmental chemicals
KW - hazard assessment
KW - new approach methodologies
KW - regulatory science
UR - https://www.scopus.com/pages/publications/105043266120
UR - https://pubmed.ncbi.nlm.nih.gov/42079015/
U2 - 10.3389/ftox.2026.1740390
DO - 10.3389/ftox.2026.1740390
M3 - Review article
C2 - 42079015
AN - SCOPUS:105043266120
SN - 2673-3080
VL - 8
JO - Frontiers in Toxicology
JF - Frontiers in Toxicology
M1 - 1740390
ER -