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

IF 3.6 Q1 TOXICOLOGY Current Opinion in Toxicology Pub Date : 2023-06-01 DOI:10.1016/j.cotox.2023.100402

Kati Hellsten, Bohumila Bichlmaier Suchanová, Virve Sihvola, Ulla Simanainen, Outi Leppäranta, Konstantinos Chronis, Dalia Simon, Ingo Bichlmaier

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引用次数: 1

Abstract

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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在欧盟REACH和CLP法规下的新研究中，研究设计在调查物质内在发育毒性特性中的重要性

对包括产前和产后发育在内的人类健康的高水平保护是关于化学品注册、评估、授权和限制(REACH)的第1907/2006号条例(EC)和关于物质和混合物分类、标签和包装(CLP)的第1272/2008号条例(EC)的主要目标。识别发育毒性物质对于保护人类胚胎、胎儿和儿童免受对其正常发育产生不利影响的化学物质的影响至关重要。这一目标要求在设计充分、适合这一目的的研究中调查物质内在的发育毒性。在本文中，我们将剂量水平、给药途径和种类作为这些关键研究参数的不适当选择来解决，这些参数降低了新研究的有效性，并可能阻碍物质作为发育毒物的识别。

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Current Opinion in Toxicology Pharmacology, Toxicology and Pharmaceutics-Toxicology

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10.40

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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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