Leiden University, Institute of Environmental Sciences (CML), P.O. Box 9518, 2300, RA, Leiden, the Netherlands.
National Institute of Public Health and the Environment (RIVM), Centre for Safety of Substances and Products, P.O. Box 1, Bilthoven, the Netherlands.
NanoImpact. 2022 Apr;26:100397. doi: 10.1016/j.impact.2022.100397. Epub 2022 Mar 25.
Similarity assessment is one of the means of optimally using scarcely available experimental data on the fate and hazards of nanoforms (NFs) for regulatory purposes. For a set of NFs that are shown to be similar it is allowed in a regulatory context to apply the information available on any of the NFs within the group to the whole set of NFs. Obviously, a proper justification for such a similarity assessment is to be provided. Within the context of exemplifying such a justification, a case study was performed aimed at assessing the similarity of a set of spherical metallic NFs that different with regard to chemical composition (three metals) and particle size (three different sizes). The endpoints of assessment were root elongation and biomass increase of lettuce (Lactuca sativa L.) seedlings and exposure assessment was performed in order to express the actual exposure concentration in terms of time-weighted average particle concentrations. The results of the study show that for the specific endpoints assessed, chemical composition is driving NF toxicity and this is mostly due to impacts on the fate of the NFs. On the other hand, particle size of Cu NFs had a negligible impact on the dose-response relationships for the specific endpoints assessed. It is thus concluded that hazard data available on spherical Cu NF tested in our case can be used to inform on the hazards of any spherical Cu NF within the size range of 25-100 nm, but only applies for the certain endpoints. Also, toxicity data for the Cu-ion are suited for such a similarity assessment.
相似性评估是优化利用纳米形式(NFs)的命运和危害的有限实验数据的手段之一,以便于进行监管。对于一组被证明具有相似性的 NFs,可以在监管范围内,将组内任何一种 NFs 的可用信息应用于整个 NFs 组。显然,需要提供这种相似性评估的合理依据。在举例说明这种合理性评估的背景下,进行了一项案例研究,旨在评估一组不同化学成分(三种金属)和粒径(三种不同尺寸)的球形金属 NFs 的相似性。评估的终点是生菜(Lactuca sativa L.)幼苗的根伸长和生物量增加,并且进行了暴露评估,以便根据时间加权平均颗粒浓度来表达实际的暴露浓度。研究结果表明,对于评估的特定终点,化学成分是 NF 毒性的驱动因素,这主要是由于对 NFs 命运的影响。另一方面,Cu NFs 的粒径对评估的特定终点的剂量-反应关系几乎没有影响。因此,结论是,我们案例中测试的球形 Cu NF 的危害数据可用于告知任何在 25-100nm 粒径范围内的球形 Cu NF 的危害,但仅适用于特定的终点。此外,Cu 离子的毒性数据也适用于这种相似性评估。