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Regul Toxicol Pharmacol. 2016 Oct;80:46-59. doi: 10.1016/j.yrtph.2016.05.037. Epub 2016 May 30.

Towards a nanospecific approach for risk assessment.

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National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands. Electronic address:
National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
ECAMRICERT, Vicenza, Italy.
LEITAT, Technological Center, Barcelona, Spain.
Directorate-General of Health (DGS) and PToNANO, Lisbon, Portugal.
National Institute of Health Doutor Ricardo Jorge (INSA) and PToNANO, Lisbon, Portugal.
Trinity College Dublin (TCD), Dublin, Ireland.
Institute Pasteur de Lille (IPL), Lille Cedex, France.
National Institute of Metrology Quality and Technology (INMETRO), Rio de Janeiro, Brazil.
Ministry of Infrastructure and the Environment (Min I&M), The Hague, the Netherlands.


In the current paper, a new strategy for risk assessment of nanomaterials is described, which builds upon previous project outcomes and is developed within the FP7 NANoREG project. NANoREG has the aim to develop, for the long term, new testing strategies adapted to a high number of nanomaterials where many factors can affect their environmental and health impact. In the proposed risk assessment strategy, approaches for (Quantitative) Structure Activity Relationships ((Q)SARs), grouping and read-across are integrated and expanded to guide the user how to prioritise those nanomaterial applications that may lead to high risks for human health. Furthermore, those aspects of exposure, kinetics and hazard assessment that are most likely to be influenced by the nanospecific properties of the material under assessment are identified. These aspects are summarised in six elements, which play a key role in the strategy: exposure potential, dissolution, nanomaterial transformation, accumulation, genotoxicity and immunotoxicity. With the current approach it is possible to identify those situations where the use of nanospecific grouping, read-across and (Q)SAR tools is likely to become feasible in the future, and to point towards the generation of the type of data that is needed for scientific justification, which may lead to regulatory acceptance of nanospecific applications of these tools.


(Q)SARs; Grouping; Nanomaterials; Prioritisation; Read-across; Risk assessment approach; Testing strategy

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