Kati Hellsten, Bohumila Bichlmaier Suchanová, Virve Sihvola, Ulla Simanainen, Outi Leppäranta, Konstantinos Chronis, Dalia Simon, Ingo Bichlmaier
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The importance of study design in investigating intrinsic developmental toxic properties of substances in new studies under the REACH and CLP Regulations in the European Union
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.
期刊介绍：
The aims and scope of Current Opinion in Toxicology is to systematically provide the reader with timely and provocative views and opinions of the highest qualified and recognized experts on current advances in selected topics within the field of toxicology. The goal is that Current Opinion in Toxicology will be an invaluable source of information and perspective for researchers, teachers, managers and administrators, policy makers and students. Division of the subject into sections: For this purpose, the scope of Toxicology is divided into six selected high impact themed sections, each of which is reviewed once a year: Mechanistic Toxicology, Metabolic Toxicology, Risk assessment in Toxicology, Genomic Toxicology, Systems Toxicology, Translational Toxicology.
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