title: Towards a nanospecific approach for risk assessment.
abstract: 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.
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands. Electronic address: susan.dekkers@rivm.nl.
authors.forename: Susan
authors.initials: S
authors.lastname: Dekkers
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
authors.forename: Agnes G
authors.initials: AG
authors.lastname: Oomen
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
authors.forename: Eric A J
authors.initials: EA
authors.lastname: Bleeker
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
authors.forename: Rob J
authors.initials: RJ
authors.lastname: Vandebriel
authors.affiliation: ECAMRICERT, Vicenza, Italy.
authors.forename: Christian
authors.initials: C
authors.lastname: Micheletti
authors.affiliation: LEITAT, Technological Center, Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Cabellos
authors.affiliation: LEITAT, Technological Center, Barcelona, Spain.
authors.forename: Gemma
authors.initials: G
authors.lastname: Janer
authors.affiliation: LEITAT, Technological Center, Barcelona, Spain.
authors.forename: Natalia
authors.initials: N
authors.lastname: Fuentes
authors.affiliation: LEITAT, Technological Center, Barcelona, Spain.
authors.forename: Socorro
authors.initials: S
authors.lastname: Vázquez-Campos
authors.affiliation: Directorate-General of Health (DGS) and PToNANO, Lisbon, Portugal.
authors.forename: Teresa
authors.initials: T
authors.lastname: Borges
authors.affiliation: National Institute of Health Doutor Ricardo Jorge (INSA) and PToNANO, Lisbon, Portugal.
authors.forename: Maria João
authors.initials: MJ
authors.lastname: Silva
authors.affiliation: Trinity College Dublin (TCD), Dublin, Ireland.
authors.forename: Adriele
authors.initials: A
authors.lastname: Prina-Mello
authors.affiliation: Trinity College Dublin (TCD), Dublin, Ireland.
authors.forename: Dania
authors.initials: D
authors.lastname: Movia
authors.affiliation: Institute Pasteur de Lille (IPL), Lille Cedex, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Nesslany
authors.affiliation: National Institute of Metrology Quality and Technology (INMETRO), Rio de Janeiro, Brazil.
authors.forename: Ana R
authors.initials: AR
authors.lastname: Ribeiro
authors.affiliation: National Institute of Metrology Quality and Technology (INMETRO), Rio de Janeiro, Brazil.
authors.forename: Paulo Emílio
authors.initials: PE
authors.lastname: Leite
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
authors.forename: Monique
authors.initials: M
authors.lastname: Groenewold
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
authors.forename: Flemming R
authors.initials: FR
authors.lastname: Cassee
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
authors.forename: Adrienne J A M
authors.initials: AJ
authors.lastname: Sips
authors.affiliation: Ministry of Infrastructure and the Environment (Min I&M), The Hague, the Netherlands.
authors.forename: Aart
authors.initials: A
authors.lastname: Dijkzeul
authors.affiliation: Ministry of Infrastructure and the Environment (Min I&M), The Hague, the Netherlands.
authors.forename: Tom
authors.initials: T
authors.lastname: van Teunenbroek
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
authors.forename: Susan W P
authors.initials: SW
authors.lastname: Wijnhoven
mesh_terms: D000818:Animals; D001711:Biotransformation; D001822:Body Burden; D003257:Consumer Product Safety; D006801:Humans; D007107:Immune System / Q000187:drug effects; D015394:Molecular Structure; D009152:Mutagenicity Tests; D053758:Nanoparticles / Q000737:chemistry / Q000378:metabolism / Q000633:toxicity*; D036103:Nanotechnology / Q000379:methods*; D061214:Patient Safety; D021281:Quantitative Structure-Activity Relationship; D018570:Risk Assessment; D012995:Solubility; D018675:Toxicity Tests / Q000379:methods*
keywords: (Q)SARs; Grouping; Nanomaterials; Prioritisation; Read-across; Risk assessment approach; Testing strategy