Publication Details

Category Text Publication
Reference Category Journals
DOI 10.3109/17435390.2013.802387
Title (Primary) Concern-driven integrated approaches to nanomaterial testing and assessment – report of the NanoSafety Cluster Working Group 10
Author Oomen, A.G.; Bos, P.M.J.; Fernandes, T.F.; Hund-Rinke, K.; Boraschi, D.; Byrne, H.J.; Aschberger, K.; Gottardo, S.; von der Kammer, F.; Kühnel, D.; Hristozov, D.; Marcomini, A.; Migliore, L.; Scott-Fordsmand, J.; Wick, P.; Landsiedel, R.
Source Titel Nanotoxicology
Year 2014
Department BIOTOX
Volume 8
Issue 3
Page From 334
Page To 348
Language englisch
Keywords nanotoxicology, 3Rs principle, human health hazard assessment, environmental hazard assessment, grouping of substances
UFZ wide themes RU2;
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.




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Persistent UFZ Identifier https://www.ufz.de/index.php?en=20939&ufzPublicationIdentifier=13951
Oomen, A.G., Bos, P.M.J., Fernandes, T.F., Hund-Rinke, K., Boraschi, D., Byrne, H.J., Aschberger, K., Gottardo, S., von der Kammer, F., Kühnel, D., Hristozov, D., Marcomini, A., Migliore, L., Scott-Fordsmand, J., Wick, P., Landsiedel, R. (2014):
Concern-driven integrated approaches to nanomaterial testing and assessment – report of the NanoSafety Cluster Working Group 10
Nanotoxicology 8 (3), 334 - 348 10.3109/17435390.2013.802387