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Best practices for developmental toxicity assessment for classification and labeling.
Daston, George Piersma, Aldert Attias, Leonello Beekhuijzen, Manon Chen, Connie Foreman, Jennifer Hallmark, Nina Leconte, Isabelle
Daston, George
Piersma, Aldert
Attias, Leonello
Beekhuijzen, Manon
Chen, Connie
Foreman, Jennifer
Hallmark, Nina
Leconte, Isabelle
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Series / Report no.
Open Access
Type
Article
Language
en
Date of publication
2018-05-14
Year of publication
Research Projects
Organizational Units
Journal Issue
Title
Best practices for developmental toxicity assessment for classification and labeling.
Translated Title
Published in
Reprod Toxicol 2018; 80:44-8
Abstract
Many chemicals are going through a hazard-based classification and labeling process in Europe. Because of the significant public health implications, the best science must be applied in assessing developmental toxicity data. The European Teratology Society and Health and Environmental Sciences Institute co-organized a workshop to consider best practices, including data quality and consistency, interpretation of developmental effects in the presence of maternal toxicity, human relevance of animal data, and limits of chemical classes. Recommendations included larger historical control databases, more pharmacokinetic studies in pregnant animals for dose setting and study interpretation, generation of mechanistic data to resolve questions about whether maternal toxicity is causative of developmental toxicity, and more rigorous specifications for what constitutes a chemical class. It is our hope that these recommendations will form the basis for subsequent consensus workshops and other scientific activities designed to improve the scientific robustness of data interpretation for classification and labeling.