Grouping of substances and read Sample Clauses

Grouping of substances and read across The general approach for grouping and read-across (e.g. OECD 2014, ECHA 2015) are in principle applicable to NMs but several additional aspects shall be considered when relevant. It is recognised that, when it comes to NMs, similarity cannot be based on structural or chemical composition only. The ECHA Group Assessing Already Registered Nanomaterials (GAARN) clarified that while read-across commonly involves substances of different chemical composition but structural similarity, read-across for NMs largely involves different nanoscale materials of the same chemical composition, i.e. different nanoforms of a certain substance addressed in the same REACH registration dossier (ECHA 2013). In addition to the Standard Information Requirements for a substance under REACH (Annexes VII-X, see sub-section 3.2), a full physicochemical characterisation of the NM is recommended, including other properties e.g.: solubility, (rate of) dissolution, specific surface area, particle size and particle size distribution, surface characteristics (including surface chemistry coating, functionalization, surface charge), hydrophobicity, agglomeration and aggregation, crystalline phase, shape/morphology, rigidity, aspect ratio, photocatalytic properties, porosity and pour density, dustiness, dispersibility, zeta potential, flammability, explosivity, and reactivity (redox potential, radical formation) as well as cellular effects, kinetics, and fate parameters like biopersistence, biodegradation (of coating), biodurability, and (toxic) ion release. Several recent scientific publications can provide additional details on how these different parameters can be used for grouping and read-across of NMs (e.g. Oomen et al. 2015). Specific recommendations for NMs are provided by ECHA/RIVM/JRC (2016). This document intends to help the user to design a testing strategy that fulfils the REACH information requirements for the substance and is schematically presented as a stepwise approach. The read- across hypothesis can be substantiated by a toxicokinetic argument related to parameters under "where they go" and a hazard argument related to parameters under "what they do" (ECHA/RIVM/JRC 2016). ECHA is currently updating its guidance on (Q)SAR and grouping of chemicals with recommendations for NMs based on, among the others, the content of this document24.
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Related to Grouping of substances and read

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