Elberskirch Linda, Sofranko Adriana, Liebing Julia, Riefler Norbert, Binder Kunigunde, Bonatto Minella Christian, Razum Matthias, Mädler Lutz, Unfried Klaus, Schins Roel P F, Kraegeloh Annette, van Thriel Christoph
INM-Leibniz Institute for New Materials, Campus D2 2, 66123 Saarbrücken, Germany.
IUF-Leibniz Research Institute for Environmental Medicine, Auf'm Hennekamp 50, 40225 Düsseldorf, Germany.
Nanomaterials (Basel). 2022 Mar 24;12(7):1053. doi: 10.3390/nano12071053.
It has been widely recognized that nanosafety studies are limited in reproducibility, caused by missing or inadequate information and data gaps. Reliable and comprehensive studies should be performed supported by standards or guidelines, which need to be harmonized and usable for the multidisciplinary field of nanosafety research. The previously described minimal information table (MIT), based on existing standards or guidelines, represents one approach towards harmonization. Here, we demonstrate the applicability and advantages of the MIT by a round-robin test. Its modular structure enables describing individual studies comprehensively by a combination of various relevant aspects. Three laboratories conducted a WST-1 cell viability assay using A549 cells to analyze the effects of the reference nanomaterials NM101 and NM110 according to predefined (S)OPs. The MIT contains relevant and defined descriptive information and quality criteria and thus supported the implementation of the round-robin test from planning, investigation to analysis and data interpretation. As a result, we could identify sources of variability and justify deviating results attributed to differences in specific procedures. Consequently, the use of the MIT contributes to the acquisition of reliable and comprehensive datasets and therefore improves the significance and reusability of nanosafety studies.
人们普遍认识到,由于信息缺失或不充分以及数据缺口,纳米安全性研究的可重复性受到限制。可靠且全面的研究应在标准或指南的支持下进行,这些标准或指南需要统一且适用于纳米安全性研究的多学科领域。基于现有标准或指南的前述最小信息表(MIT)是实现统一的一种方法。在此,我们通过循环试验证明了MIT的适用性和优势。其模块化结构能够通过组合各种相关方面来全面描述单个研究。三个实验室根据预定义的标准操作规程(SOP),使用A549细胞进行了WST-1细胞活力测定,以分析参考纳米材料NM101和NM110的影响。MIT包含相关且明确的描述性信息和质量标准,从而支持了从规划、调查到分析及数据解释的循环试验的实施。结果,我们能够识别变异性来源,并为因特定程序差异导致的偏差结果提供合理依据。因此,MIT的使用有助于获取可靠且全面的数据集,从而提高纳米安全性研究的重要性和可重用性。