Publication Details

Category Text Publication
Reference Category Journals
DOI 10.3389/ftox.2026.1740390
Licence creative commons licence
Title (Primary) New approach methodologies (NAMs) to support regulatory assessment of developmental immunotoxicity – a new PARC project
Author Smith, N.M.; de Bruijn, V.M.P.; Vandebriel, R.J.; Hargitai, R.; Lumniczky, K.; Janssen, A.W.F.; Beekmann, K.; Usta, B.; Tigges, J.; Spruck, C.; Hurem, S.; Iulini, M.; Corsini, E.; Bado-Nilles, A.; Beaudouin, R.; Katsiadaki, I.; Cano, I.; Sebire, M.; Ayuk, H.S.; Stojanovska, V.; Zenclussen, A.C.; Blanc, E.B.; Kerdine-Römer, S.; Lacerda, R.; Romão, L.; Monfort-Lanzas, P.; Gostner, J.M.; Mposhi, A.; Turner, J.D.; Del Favero, G.; Lindeman, B.
Source Titel Frontiers in Toxicology
Year 2026
Department IMMU
Volume 8
Page From art. 1740390
Language englisch
Topic T9 Healthy Planet
Supplements Supplement 1
Keywords developmental immunotoxicity; environmental chemicals; hazard assessment; new approach methodologies; PARC; regulatory science
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.

Smith, N.M., de Bruijn, V.M.P., Vandebriel, R.J., Hargitai, R., Lumniczky, K., Janssen, A.W.F., Beekmann, K., Usta, B., Tigges, J., Spruck, C., Hurem, S., Iulini, M., Corsini, E., Bado-Nilles, A., Beaudouin, R., Katsiadaki, I., Cano, I., Sebire, M., Ayuk, H.S., Stojanovska, V., Zenclussen, A.C., Blanc, E.B., Kerdine-Römer, S., Lacerda, R., Romão, L., Monfort-Lanzas, P., Gostner, J.M., Mposhi, A., Turner, J.D., Del Favero, G., Lindeman, B. (2026):
New approach methodologies (NAMs) to support regulatory assessment of developmental immunotoxicity – a new PARC project
Front. Toxicol. 8 , art. 1740390
10.3389/ftox.2026.1740390