Rationale and decision rules behind the ECETOC NanoApp to support registration of sets of similar nanoforms within REACH

Abstract

New registration requirements for nanomaterials under REACH consider the possibility to form ‘sets of similar nanoforms’ for a joined human health and environmental hazard, exposure and risk assessment. We developed a tool to create and justify sets of similar nanoforms and to ensure that each of the nanoforms is sufficiently similar to all other nanoforms. The decision logic is following the ECHA guidance in a transparent and evidence-based manner. For each two nanoforms the properties under consideration are compared and corresponding thresholds for maximal differences are proposed. In tier1, similarity is assessed based on intrinsic properties that mostly correspond to those required for nanoform identification under REACH: composition, impurities/additives, size, crystallinity, shape and surface treatment. Moreover, potential differences in the agglomeration/aggregation state resulting from different production processes are considered. If nanoforms were not sufficiently similar based on tier1 criteria, additional data from functional assays are required in tier2. In rare cases, additional short-term in vivo rodent data could be required in a third tier. Data required by tier 2 are triggered by the intrinsic properties in the first tier that did not match the similarity criteria. Most often this will be data on dissolution and surface reactivity followed by in vitro toxicity, dispersion stability, dustiness. Out of several nanoforms given by the user, the tool concludes which nanoforms could be justified to be in the same set and which nanoforms are outside. It defines the boundaries of sets of similar nanoforms and generates a justification for the REACH registration.

Keywords:

• Nanoform
• set of similar nanoforms
• similarity
• intrinsic properties
• REACH registration

Disclosure statement

Robert Landsiedel and Wendel Wohlleben are employees of a company producing and marketing nanomaterials.

Additional information

Funding

This work was funded by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) (http://www.ecetoc.org). GJ is part of the Emerging Reserch Group of the ‘Generalitat de Catalunya’ [Ref. 2017 SGR 1759].