a National Institute for Public Health and the Environment, Centre for Health Protection , Bilthoven , The Netherlands.
b Finnish Institute of Occupational Health , Helsinki , Finland.
Nanotoxicology. 2018 Sep;12(7):652-676. doi: 10.1080/17435390.2018.1465142. Epub 2018 May 6.
Within the EU FP-7 GUIDEnano project, a methodology was developed to systematically quantify the similarity between a nanomaterial (NM) that has been tested in toxicity studies and the NM for which risk needs to be evaluated, for the purpose of extrapolating toxicity data between the two materials. The methodology is a first attempt to use current knowledge on NM property-hazard relationships to develop a series of pragmatic and systematic rules for assessing NM similarity. Moreover, the methodology takes into account the practical feasibility, in that it is based on generally available NM characterization information. In addition to presenting this methodology, the lessons learnt and the challenges faced during its development are reported here. We conclude that there is a large gap between the information that is ideally needed and its application to real cases. The current database on property-hazard relationships is still very limited, which hinders the agreement on the key NM properties constituting the basis of the similarity assessment and the development of associated science-based and unequivocal rules. Currently, one of the most challenging NM properties to systematically assess in terms of similarity between two NMs is surface coating and functionalization, which lacks standardized parameters for description and characterization methodology. Standardization of characterization methods that lead to quantitative, unambiguous, and measurable parameters describing NM properties are necessary in order to build a sufficiently robust property-hazard database that allows for evidence-based refinement of our methodology, or any other attempt to systematically assess the similarity of NMs.
在欧盟 FP-7 GUIDEnano 项目中，开发了一种方法来系统地量化已在毒性研究中测试的纳米材料 (NM) 与需要评估风险的 NM 之间的相似性，以便在两种材料之间推断毒性数据。该方法首次尝试利用当前关于 NM 属性-危害关系的知识，制定一系列实用且系统的规则来评估 NM 相似性。此外，该方法考虑到了实际可行性，因为它基于普遍可用的 NM 特性信息。除了介绍这种方法外，本文还报告了在其开发过程中获得的经验教训和面临的挑战。我们得出的结论是，理想情况下需要的信息与其在实际案例中的应用之间存在很大差距。目前关于属性-危害关系的数据库仍然非常有限，这阻碍了就构成相似性评估基础的关键 NM 特性达成一致意见，并阻碍了制定相关的基于科学和明确的规则。目前，在评估两种 NM 之间相似性时，最具挑战性的 NM 特性之一是表面涂层和功能化，因为它缺乏描述和表征方法的标准化参数。为了构建一个足够稳健的属性-危害数据库，以便基于证据改进我们的方法，或任何其他尝试系统地评估 NM 的相似性，有必要对导致描述 NM 属性的定量、明确和可测量参数的表征方法进行标准化。
