title: Concern-driven integrated approaches to nanomaterial testing and assessment--report of the NanoSafety Cluster Working Group 10.
abstract: Bringing together topic-related European Union (EU)-funded projects, the so-called "NanoSafety Cluster" aims at identifying key areas for further research on risk assessment procedures for nanomaterials (NM). The outcome of NanoSafety Cluster Working Group 10, this commentary presents a vision for concern-driven integrated approaches for the (eco-)toxicological testing and assessment (IATA) of NM. Such approaches should start out by determining concerns, i.e., specific information needs for a given NM based on realistic exposure scenarios. Recognised concerns can be addressed in a set of tiers using standardised protocols for NM preparation and testing. Tier 1 includes determining physico-chemical properties, non-testing (e.g., structure-activity relationships) and evaluating existing data. In tier 2, a limited set of in vitro and in vivo tests are performed that can either indicate that the risk of the specific concern is sufficiently known or indicate the need for further testing, including details for such testing. Ecotoxicological testing begins with representative test organisms followed by complex test systems. After each tier, it is evaluated whether the information gained permits assessing the safety of the NM so that further testing can be waived. By effectively exploiting all available information, IATA allow accelerating the risk assessment process and reducing testing costs and animal use (in line with the 3Rs principle implemented in EU Directive 2010/63/EU). Combining material properties, exposure, biokinetics and hazard data, information gained with IATA can be used to recognise groups of NM based upon similar modes of action. Grouping of substances in return should form integral part of the IATA themselves.
authors: IVM, National Institute for Public Health and the Environment , Bilthoven , The Netherlands.
authors: Agnes G
authors: AG
authors: Oomen
authors: Peter M J
authors: PM
authors: Bos
authors: Teresa F
authors: TF
authors: Fernandes
authors: Kerstin
authors: K
authors: Hund-Rinke
authors: Diana
authors: D
authors: Boraschi
authors: Hugh J
authors: HJ
authors: Byrne
authors: Karin
authors: K
authors: Aschberger
authors: Stefania
authors: S
authors: Gottardo
authors: Frank
authors: F
authors: von der Kammer
authors: Dana
authors: D
authors: Kühnel
authors: Danail
authors: D
authors: Hristozov
authors: Antonio
authors: A
authors: Marcomini
authors: Lucia
authors: L
authors: Migliore
authors: Janeck
authors: J
authors: Scott-Fordsmand
authors: Peter
authors: P
authors: Wick
authors: Robert
authors: R
authors: Landsiedel
mesh_terms: D000818:Animals; D002460:Cell Line; D005062:European Union; D006801:Humans; D049329:Nanostructures / Q000592:standards / Q000633:toxicity; D018570:Risk Assessment; D018675:Toxicity Tests
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