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 article

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)136-141
Number of pages6
JournalReproductive Toxicology
Volume72
DOIs
Publication statusPublished - Sep 1 2017

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Chemical hazards
Population Groups
Risk assessment
Toxicity
Pediatrics
Disinfectants
Testing
Guidelines
Pesticides
Toxicity Tests
Toxicology
Pharmaceutical Preparations

Keywords

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

ASJC Scopus subject areas

  • Toxicology

Cite this

The juvenile toxicity study as a tool for a science-based risk assessment in the children population group. / Narciso, Laura; Catone, Tiziana; Aquilina, Gabriele; Attias, Leonello; De Angelis, Isabella; Iuliano, Maria Grazia; Tassinari, Roberta; Mantovani, Alberto; Maranghi, Francesca.

In: Reproductive Toxicology, Vol. 72, 01.09.2017, p. 136-141.

Research output: Contribution to journalReview article

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AU - De Angelis, Isabella

AU - Iuliano, Maria Grazia

AU - Tassinari, Roberta

AU - Mantovani, Alberto

AU - Maranghi, Francesca

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AB - 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.

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