A Framework for Grouping and Read-Across of Nanomaterials- Supporting Innovation and Risk Assessment

According to legislation grouping can streamline data generation for the risk assessment of substances. The GRACIOUS Framework aims to support the grouping to nanomaterials or nanoforms (NFs), in a regulatory context and to support innovation. This includes using grouping to support 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 case-specific 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.

STONE Vicki;  GOTTARDO Stefania;  BLEEKER Eric;  BRAAKHUIS Hedwig;  DEKKERS Susan;  FERNANDES Teresa F.;  HAASE Andrea;  HUNT Neil;  HRISTOZOV Danail;  JANTUNEN Anna Paula;  JELIAZKOVA Nina;  JOHNSTON Helinor;  LAMON Lara;  MURPHY Fiona;  RASMUSSEN Kirsten;  RAUSCHER Hubert;  CLAUS Svendsen;  SANCHEZ JIMENEZ Araceli;  SPURGEON David;  VÁZQUEZ-CAMPOS Socorro;  WOHLLEBEN Wendel;  OOMEN Agnes; 

2020-08-14

ELSEVIER SCI LTD

JRC117973

1748-0132 (online),   

https://publications.jrc.ec.europa.eu/repository/handle/JRC117973,   

10.1016/j.nantod.2020.100941 (online),