Best practices for developmental toxicity assessment for classification and labeling.
Cast your vote
You can rate an item by clicking the amount of stars they wish to award to this item.
When enough users have cast their vote on this item, the average rating will also be shown.
Your vote was cast
Thank you for your feedback
Thank you for your feedback
MetadataShow full item record
TitleBest practices for developmental toxicity assessment for classification and labeling.
Published inReprod Toxicol 2018; advance online publication (ahead of print)
PubliekssamenvattingMany 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.
- Recommendations for harmonization of data collection and analysis of developmental neurotoxicity endpoints in regulatory guideline studies: Proceedings of workshops presented at Society of Toxicology and joint Teratology Society and Neurobehavioral Teratology Society meetings.
- Authors: Li AA, Sheets LP, Raffaele K, Moser V, Hofstra A, Hoberman A, Makris SL, Garman R, Bolon B, Kaufmann W, Auer R, Lau E, Vidmar T, Bowers WJ
- Issue date: 2017 Sep
- A quantitative weight of evidence methodology for the assessment of reproductive and developmental toxicity and its application for classification and labeling of chemicals.
- Authors: Dekant W, Bridges J
- Issue date: 2016 Dec
- A GHS-consistent approach to health hazard classification of petroleum substances, a class of UVCB substances.
- Authors: Clark CR, McKee RH, Freeman JJ, Swick D, Mahagaokar S, Pigram G, Roberts LG, Smulders CJ, Beatty PW
- Issue date: 2013 Dec
- The European Community Directive on the classification and labeling of chemicals for reproductive toxicity.
- Authors: Sullivan FM
- Issue date: 1995 Aug
- How accurate are the European Union's classifications of chemical substances.
- Authors: Rudén C, Hansson SO
- Issue date: 2003 Sep 30