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

Vicki Stone, Stefania Gottardo, Eric A. J. Bleeker, Hedwig Braakhuis, Susan Dekkers, Teresa Fernandes, Andrea Haase, Neil Hunt, Danail Hristozov, Paula Jantunen, Nina Jeliazkova, Helinor Johnston, Lara Lamon, Fiona Murphy, Kirsten Rasmussen, Hubert Rauscher, Araceli Sánchez Jiménez, Claus Svendsen, David Spurgeon, Socorro Vázquez-CamposWendel Wohlleben, Agnes G. Oomen

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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.
Original languageEnglish
Article number100941
JournalNano Today
Early online date8 Aug 2020
Publication statusPublished - Dec 2020


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