National Institute for Public Health and the Environment (RIVM), Centre for Safety of Substances and Products (VSP), Bilthoven, the Netherlands.
National Institute for Public Health and the Environment (RIVM), Centre for Safety of Substances and Products (VSP), Bilthoven, the Netherlands.
Regul Toxicol Pharmacol. 2023 Sep;143:105462. doi: 10.1016/j.yrtph.2023.105462. Epub 2023 Jul 26.
Hazard classification and risk assessment of substances, is essential to protect workers and consumers from hazardous substances including reproductive toxicants. The ability to classify substances for reproductive toxicity under the current REACH information requirements has been assessed. For low tonnage substances (<10 ton per annum (tpa)) information for classification is insufficient. When only a reproductive screening study is available (10-100 tpa), substances are mostly not classified in Category 1B as developmental and non-potent fertility effects may be missed. The information requirements could be improved by automatic triggering of follow-up studies in case of a Category 2 classification based on a screening study. Additionally, a study could be added to the information requirements for substances produced at 1-10 tpa. Performing a risk assessment is often problematic due to the limited study requirements at low tonnage levels. Only for substances produced at more than 100 tpa, there is a high likelihood to detect reproductive effects and perform accurate risk assessment provided that the extended-one-generation-reproductive-toxicity-study and/or extra cohorts are triggered where required. Regardless of the tonnage level, no specific studies on lactation are required. With this paper we intend to contribute to the discussion on the information requirements for reproductive toxicity in view of the REACH revision.
物质的危险分类和风险评估对于保护工人和消费者免受危险物质（包括生殖毒性物质）的危害至关重要。本文评估了在当前 REACH 信息要求下对生殖毒性物质进行分类的能力。对于低吨位物质（<10 吨/年（tpa）），分类信息不足。当仅可获得生殖筛选研究（10-100 tpa）时，由于可能会错过发育和非潜在生育力效应，大多数物质不会被归类为 1B 类。如果基于筛选研究对 2 类物质进行分类，则可以通过自动触发后续研究来改进信息要求。此外，可以为 1-10 tpa 生产的物质添加研究。由于在低吨位水平下的研究要求有限，因此进行风险评估通常存在问题。仅对于生产超过 100 tpa 的物质，在扩展一代生殖毒性研究和/或额外队列的情况下，有很高的可能性检测到生殖效应并进行准确的风险评估。无论吨位水平如何，都不需要进行专门的哺乳期研究。本文旨在为 REACH 修订版中生殖毒性信息要求的讨论做出贡献。
