Towards a nanospecific approach for risk assessment.
Dekkers, Susan; Oomen, Agnes G.; Bleeker, Eric A.J.; Vandebriel, Rob J.; Micheletti, Christian; Cabellos, Joan; Janer, Gemma; Fuentes, Natalia; Vazquez-Campos, Socorro; Borges, Teresa; Silva, Maria Joao; Prina-Mello, Adriele; Movia, Dania; Nesslany, Fabrice; Ribeiro, Ana R.; Leite, Paulo Emilio; Groenewold, Monique; Cassee, Flemming R.; Sips, Adrienne J.A.M.; Dijkzeul, Aart; van Teunenbroek, Tom; Wijnhoven, Susan W.P.
[Article]
Regulatory Toxicology and Pharmacology.
80:46-59, October 2016.
(Format: HTML, PDF)
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.
Highlights:
* This approach facilitates further development of a more efficient risk assessment for nanomaterials in the future.
* It uses the current scientific insights in the specific properties that are crucial in the behaviour and toxicity of nanomaterials.
* It accelerates the rate at which information needed for risk assessment can be generated.
(C) 2016Elsevier, Inc.