Best practices for developmental toxicity assessment for classification and labeling.
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Authors
Daston, GeorgePiersma, Aldert
Attias, Leonello
Beekhuijzen, Manon
Chen, Connie
Foreman, Jennifer
Hallmark, Nina
Leconte, Isabelle
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ArticleLanguage
en
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Best practices for developmental toxicity assessment for classification and labeling.Published in
Reprod Toxicol 2018; advance online publication (ahead of print)Publiekssamenvatting
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.PMID
29753929ae974a485f413a2113503eed53cd6c53
10.1016/j.reprotox.2018.05.001
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