A framework for grouping and read-across of nanomaterials- supporting innovation and risk assessment

Stone, Vicki and Gottardo, Stefania and Bleeker, Eric A.J. and Braakhuis, Hedwig and Dekkers, Susan and Fernandes, Teresa and Haase, Andrea and Hunt, Neil and Hristozov, Danail and Jantunen, Paula and Jeliazkova, Nina and Johnston, Helinor and Lamon, Lara and Murphy, Fiona and Rasmussen, Kirsten and Rauscher, Hubert and Jiménez, Araceli Sánchez and Svendsen, Claus and Spurgeon, David and Vázquez-Campos, Socorro and Wohlleben, Wendel and Oomen, Agnes G. (2020) A framework for grouping and read-across of nanomaterials- supporting innovation and risk assessment. Nano Today, 35. 100941. ISSN 1878-044X (https://doi.org/10.1016/j.nantod.2020.100941)

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According to some legislation grouping can streamline data gap filling for the hazard assessment of substances. The GRACIOUS Framework aims to facilitate the application of grouping of nanomaterials or nanoforms (NFs), in a regulatory context and to support innovation. This includes using grouping to enable read-across from (a) source(s), for which data and information exist, to a similar target NF where information is lacking. The Framework provides an initial set of hypotheses for the grouping of NFs which take into account the identity and use(s) of the NFs, as well as the purpose of grouping. Initial collection of basic information allows selection of an appropriate pre-defined grouping hypothesis and a tailored Integrated Approach to Testing and Assessment (IATA), designed to generate new evidence to support acceptance or rejection of the hypothesis. Users needing to develop their own user-defined hypothesis (and IATA) are also supported by the Framework. In addition, the IATA guides acquisition of the information needed to support read-across. This approach gathers information to render risk assessment more efficient, affordable, as well as reducing the use of test animals.