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

ABSTRACT

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.