Methodological review highlights critical parameters in developmental toxicity testing under REACH and CLP regulations, suggesting improper study designs hamper chemical hazard identification.
A high level of protection of human health including pre- and postnatal development is a main objective of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP). Identifying developmental toxicants is crucial for protecting human embryos, foetuses and children from exposure to chemicals that adversely affect their normal development. This objective requires the intrinsic developmental toxic properties of substances to be investigated in adequately designed studies that are fit for this purpose. In this article, we address dose levels, administration route and species as an inadequate selection of these critical study parameters that reduces the usefulness of new studies and may hamper the identification of substances as developmental toxicants.
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Hellsten et al. (2023) studied this question.
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