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

Laura Narciso, Tiziana Catone, Gabriele Aquilina, Leonello Attias, Isabella De Angelis, Maria Grazia Iuliano, Roberta Tassinari, Alberto Mantovani, Francesca Maranghi

Research output: Contribution to journalReview articlepeer-review


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.

Original languageEnglish
Pages (from-to)136-141
Number of pages6
JournalReproductive Toxicology
Publication statusPublished - Sep 1 2017


  • Chemicals
  • Immature
  • Population sub-group
  • Susceptibility
  • Toxicological test

ASJC Scopus subject areas

  • Toxicology


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