Best practices for developmental toxicity assessment for classification and labeling

George Daston, Aldert Piersma, Leonello Attias, Manon Beekhuijzen, Connie Chen, Jennifer Foreman, Nina Hallmark, Isabelle Leconte

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)44-48
Number of pages5
JournalReproductive Toxicology
Volume80
DOIs
Publication statusPublished - Sep 1 2018

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Keywords

  • Classification and labeling
  • Developmental toxicity

ASJC Scopus subject areas

  • Toxicology

Cite this

Daston, G., Piersma, A., Attias, L., Beekhuijzen, M., Chen, C., Foreman, J., Hallmark, N., & Leconte, I. (2018). Best practices for developmental toxicity assessment for classification and labeling. Reproductive Toxicology, 80, 44-48. https://doi.org/10.1016/j.reprotox.2018.05.001