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    Best practices for developmental toxicity assessment for classification and labeling.

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    Authors
    Daston, George
    Piersma, Aldert
    Attias, Leonello
    Beekhuijzen, Manon
    Chen, Connie
    Foreman, Jennifer
    Hallmark, Nina
    Leconte, Isabelle
    Type
    Article
    Language
    en
    
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    Title
    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.
    DOI
    10.1016/j.reprotox.2018.05.001
    PMID
    29753929
    URI
    http://hdl.handle.net/10029/621958
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.reprotox.2018.05.001
    Scopus Count
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