Dekkers Susan, Oomen Agnes G, Bleeker Eric A J, Vandebriel Rob J, Micheletti Christian, Cabellos Joan, Janer Gemma, Fuentes Natalia, Vázquez-Campos Socorro, Borges Teresa, Silva Maria João, Prina-Mello Adriele, Movia Dania, Nesslany Fabrice, Ribeiro Ana R, Leite Paulo Emílio, Groenewold Monique, Cassee Flemming R, Sips Adrienne J A M, Dijkzeul Aart, van Teunenbroek Tom, Wijnhoven Susan W P
National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
Regul Toxicol Pharmacol. 2016 Oct;80:46-59. doi: 10.1016/j.yrtph.2016.05.037. Epub 2016 May 30.
In the current paper, a new strategy for risk assessment of nanomaterials is described, which builds upon previous project outcomes and is developed within the FP7 NANoREG project. NANoREG has the aim to develop, for the long term, new testing strategies adapted to a high number of nanomaterials where many factors can affect their environmental and health impact. In the proposed risk assessment strategy, approaches for (Quantitative) Structure Activity Relationships ((Q)SARs), grouping and read-across are integrated and expanded to guide the user how to prioritise those nanomaterial applications that may lead to high risks for human health. Furthermore, those aspects of exposure, kinetics and hazard assessment that are most likely to be influenced by the nanospecific properties of the material under assessment are identified. These aspects are summarised in six elements, which play a key role in the strategy: exposure potential, dissolution, nanomaterial transformation, accumulation, genotoxicity and immunotoxicity. With the current approach it is possible to identify those situations where the use of nanospecific grouping, read-across and (Q)SAR tools is likely to become feasible in the future, and to point towards the generation of the type of data that is needed for scientific justification, which may lead to regulatory acceptance of nanospecific applications of these tools.
在当前论文中，描述了一种纳米材料风险评估的新策略，该策略基于先前的项目成果，并在第七框架计划（FP7）的NANoREG项目中得以发展。NANoREG旨在长期开发适用于大量纳米材料的新测试策略，其中许多因素会影响它们对环境和健康的影响。在所提出的风险评估策略中，（定量）结构活性关系（（Q）SARs）、分组和类推法等方法被整合并扩展，以指导用户如何对那些可能对人类健康造成高风险的纳米材料应用进行优先排序。此外，还确定了暴露、动力学和危害评估中最有可能受评估材料的纳米特性影响的那些方面。这些方面被总结为六个要素，它们在该策略中起着关键作用：暴露潜力､溶解､纳米材料转化､积累､遗传毒性和免疫毒性。采用当前方法，有可能识别出未来使用纳米特异性分组、类推法和（Q）SAR工具可能变得可行的那些情况，并指明生成科学论证所需数据类型的方向，这可能会导致监管机构接受这些工具在纳米特异性应用方面的使用。
