The juvenile toxicity study as a tool for a science-based risk assessment in the children population group

•Children show unique features concerning chemical hazards and risks related to specific biological susceptibility.•Regulatory frameworks for chemicals state the need for a children-targeted risk characterization.•Testing approach addressing regulatory requirements of chemical risk assessment in children perspective.•New ad hoc OECD test guideline or, alternatively, updating of existing guidelines.

Children show unique features concerning chemical hazards and risks, due to different exposure scenarios, age-related metabolic capacity and biological susceptibility linked to post-natal development. Chemical Regulatory frameworks state the need of children risk characterization. Current testing guidelines covering post-natal development are not routinely required by regulatory applications other than pesticides and biocides. Juvenile toxicity studies are foreseen for paediatric drugs: the toxicological repeated-dose tests don't allow accurate evaluations of effects upon direct exposure of immature organism. The paper discusses a testing approach aimed to address regulatory requirements of chemical hazard identification/characterization in a children-specific perspective. Juvenile toxicity test could be performed primarily on chemicals that may have relevant modes of action and/or age-related toxicokinetic differences and/or lead to important children exposure. This could be pursued by updating existing guidelines/test protocols with triggers for endpoints relevant to juvenile toxicity.