Title: Concern-driven integrated approaches to nanomaterials testing and assessment - Report of the NanoSafety Cluster Working Group 10
Authors: OOMEN AgnesBOS Peter M. J.FERNANDES Teresa F.HUND-RINKE K.BORASCHI DianaBYRNE Hugh J.ASCHBERGER KARINGOTTARDO STEFANIAVON DER KAMMER FrankKÜHNEL DanaHRISTOZOV DanailMARCOMINI AntonioMIGLIORE LuciaSCOTT-FORDSMAND JaneckWICK PeterLANDSIEDEL Robert
Citation: NANOTOXICOLOGY vol. 8 no. 3 p. 334-348
Publisher: INFORMA HEALTHCARE
Publication Year: 2014
JRC N°: JRC81449
ISSN: 1743-5390
URI: http://informahealthcare.com/doi/abs/10.3109/17435390.2013.802387
http://publications.jrc.ec.europa.eu/repository/handle/JRC81449
DOI: 10.3109/17435390.2013.802387
Type: Articles in periodicals and books
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. Recognized concerns can be addressed in a set of tiers using standardized 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 recognize groups of NM based upon similar modes-of-action. Grouping of substances in return should form integral part of the IATA themselves.
JRC Directorate:Institute for Health and Consumer Protection Historical Collection

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