Creating sets of similar nanoforms with the ECETOC NanoApp: real-life case studies
Abstract
Abstract The ECETOC NanoApp was developed to support industry in the registration of sets of nanoforms, as well as regulators in the evaluation of these registration dossiers. The ECETOC NanoApp uses a systematic approach to create and justify sets of similar nanoforms, following the ECHA guidance in a transparent and evidence-based manner. The rational and decision rules behind the ECETOC NanoApp are described in detail in “Janer, G., R. Landsiedel, and W. Wohlleben. 2021. [Rationale and Decision Rules Behind the ECETOC NanoApp to Support Registration of Sets of Similar Nanoforms within REACH. Nanotoxicology 15 (2): 145–122. https://doi.org/10.1080/17435390.2020.1842933]”. The decision criteria apply to human health and environmental hazards and risks. Here, we focus mostly on human health hazards; the decision rules are applied to a series of case studies, each consisting of real nanoforms: two barium sulfate nanoforms, four colloidal silica nanoforms, eight ceria nanoforms, and four copper phthalocyanine nanoforms. For each of them, we show step by step how the ECETOC NanoApp rules are applied. The cases include nanoforms that are justified as members of the same set of similar nanoforms based on sufficient similarity of their intrinsic properties (Tier 1). They also include other nanoforms with a relatively high (but insufficient) similarity of intrinsic properties; their similarity could be justified by functional properties (Tier 2). The case studies also include…
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