Arts Josje H E, Hadi Mackenzie, Keene Athena M, Kreiling Reinhard, Lyon Delina, Maier Monika, Michel Karin, Petry Thomas, Sauer Ursula G, Warheit David, Wiench Karin, Landsiedel Robert
AkzoNobel, Technology and Engineering, Arnhem, Netherlands.
Shell Health, Shell International B.V., The Hague, Netherlands.
Regul Toxicol Pharmacol. 2014 Nov;70(2):492-506. doi: 10.1016/j.yrtph.2014.07.025. Epub 2014 Aug 7.
The grouping of substances serves to streamline testing for regulatory purposes. General grouping approaches for chemicals have been implemented in, e.g., the EU chemicals regulation. While specific regulatory frameworks for the grouping of nanomaterials are unavailable, this topic is addressed in different publications, and preliminary guidance is provided in the context of substance-related legislation or the occupational setting. The European Centre for Ecotoxicology and Toxicology of Chemicals Task Force on the Grouping of Nanomaterials reviewed available concepts for the grouping of nanomaterials for human health risk assessment. In their broad conceptual design, the evaluated approaches are consistent or complement each other. All go beyond the determination of mere structure-activity relationships and are founded on different aspects of the nanomaterial life cycle. These include the NM's material properties and biophysical interactions, specific types of use and exposure, uptake and kinetics, and possible early and apical biological effects. None of the evaluated grouping concepts fully take into account all of these aspects. Subsequent work of the Task Force will aim at combining the available concepts into a comprehensive 'multiple perspective' framework for the grouping of nanomaterials that will address all of the mentioned aspects of their life cycles.
为了便于进行监管测试,需要对物质进行分组。例如,欧盟化学品法规中已实施了化学品的一般分组方法。虽然目前尚无针对纳米材料分组的具体监管框架,但不同的出版物探讨了这一主题,并在物质相关立法或职业环境的背景下提供了初步指导。欧洲化学品生态毒理学和毒理学中心纳米材料分组特别工作组审查了用于人类健康风险评估的纳米材料分组的现有概念。在其广泛的概念设计中,所评估的方法相互一致或相互补充。所有这些方法都超越了单纯的构效关系确定,而是基于纳米材料生命周期的不同方面。这些方面包括纳米材料的材料特性和生物物理相互作用、特定的使用和暴露类型、吸收和动力学,以及可能的早期和顶端生物学效应。所评估的分组概念均未完全考虑到所有这些方面。特别工作组的后续工作将致力于将现有概念整合为一个全面的“多视角”纳米材料分组框架,该框架将涵盖纳米材料生命周期中上述所有方面。