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 language | English |
|---|---|
| Pages (from-to) | 136-141 |
| Number of pages | 6 |
| Journal | Reproductive Toxicology |
| Volume | 72 |
| DOIs | |
| Publication status | Published - Sep 1 2017 |
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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 journal › Review article
}
TY - JOUR
T1 - The juvenile toxicity study as a tool for a science-based risk assessment in the children population group
AU - Narciso, Laura
AU - Catone, Tiziana
AU - Aquilina, Gabriele
AU - Attias, Leonello
AU - De Angelis, Isabella
AU - Iuliano, Maria Grazia
AU - Tassinari, Roberta
AU - Mantovani, Alberto
AU - Maranghi, Francesca
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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.
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.
KW - Chemicals
KW - Immature
KW - Population sub-group
KW - Susceptibility
KW - Toxicological test
UR - http://www.scopus.com/inward/record.url?scp=85024125538&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85024125538&partnerID=8YFLogxK
U2 - 10.1016/j.reprotox.2017.06.188
DO - 10.1016/j.reprotox.2017.06.188
M3 - Review article
AN - SCOPUS:85024125538
VL - 72
SP - 136
EP - 141
JO - Reproductigve Toxicoloy
JF - Reproductigve Toxicoloy
SN - 0890-6238
ER -