title: Grouping and Read-Across Approaches for Risk Assessment of Nanomaterials.
abstract: Physicochemical properties of chemicals affect their exposure, toxicokinetics/fate and hazard, and for nanomaterials, the variation of these properties results in a wide variety of materials with potentially different risks. To limit the amount of testing for risk assessment, the information gathering process for nanomaterials needs to be efficient. At the same time, sufficient information to assess the safety of human health and the environment should be available for each nanomaterial. Grouping and read-across approaches can be utilised to meet these goals. This article presents different possible applications of grouping and read-across for nanomaterials within the broader perspective of the MARINA Risk Assessment Strategy (RAS), as developed in the EU FP7 project MARINA. Firstly, nanomaterials can be grouped based on limited variation in physicochemical properties to subsequently design an efficient testing strategy that covers the entire group. Secondly, knowledge about exposure, toxicokinetics/fate or hazard, for example via properties such as dissolution rate, aspect ratio, chemical (non-)activity, can be used to organise similar materials in generic groups to frame issues that need further attention, or potentially to read-across. Thirdly, when data related to specific endpoints is required, read-across can be considered, using data from a source material for the target nanomaterial. Read-across could be based on a scientifically sound justification that exposure, distribution to the target (fate/toxicokinetics) and hazard of the target material are similar to, or less than, the source material. These grouping and read-across approaches pave the way for better use of available information on nanomaterials and are flexible enough to allow future adaptations related to scientific developments.
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720, The Netherlands. Agnes.Oomen@rivm.nl.
authors.forename: Agnes G
authors.initials: AG
authors.lastname: Oomen
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720, The Netherlands. Eric.Bleeker@rivm.nl.
authors.forename: Eric A J
authors.initials: EA
authors.lastname: Bleeker
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720, The Netherlands. Peter.Bos@rivm.nl.
authors.forename: Peter M J
authors.initials: PM
authors.lastname: Bos
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720, The Netherlands. Fleur.van.Broekhuizen@rivm.nl.
authors.forename: Fleur
authors.initials: F
authors.lastname: van Broekhuizen
authors.affiliation: Joint Research Centre, European Commission, Via E. Fermi 2749, Ispra 21027, Italy. Stefania.GOTTARDO@ec.europa.eu.
authors.forename: Stefania
authors.initials: S
authors.lastname: Gottardo
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720, The Netherlands. Monique.Groenewold@rivm.nl.
authors.forename: Monique
authors.initials: M
authors.lastname: Groenewold
authors.affiliation: Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, Vegapark, Via delle Industrie 21/8, Marghera 30175, Venice, Italy. Danail.Hristozov@unive.it.
authors.forename: Danail
authors.initials: D
authors.lastname: Hristozov
authors.affiliation: Fraunhofer Institute for Molecular Biology and Applied Ecology, Auf dem Aberg 1, Schmallenberg 57392, Germany. Kerstin.Hund-Rinke@ime.fraunhofer.de.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Hund-Rinke
authors.affiliation: BASF SE, GB/TB-Z470, Ludwigshafen 67056, Germany. muhammad-adeel.irfan@basf.com.
authors.forename: Muhammad-Adeel
authors.initials: MA
authors.lastname: Irfan
authors.affiliation: Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, Vegapark, Via delle Industrie 21/8, Marghera 30175, Venice, Italy. marcom@unive.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: Marcomini
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720, The Netherlands. peijnenburg@cml.leidenuniv.nl.|Centre for Environmental Sciences, University Leiden, PO Box 9518, Leiden 2300, The Netherlands. peijnenburg@cml.leidenuniv.nl.
authors.forename: Willie J G M
authors.initials: WJ
authors.lastname: Peijnenburg
authors.affiliation: Joint Research Centre, European Commission, Via E. Fermi 2749, Ispra 21027, Italy. Kirsten.RASMUSSEN@ec.europa.eu.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Rasmussen
authors.affiliation: Centre for Human Exposure Science (CHES), Institute of Occupational Medicine (IOM), Edinburgh EH14 4AP, UK. Araceli.Sanchez@iom-world.org.
authors.forename: Araceli Sánchez
authors.initials: AS
authors.lastname: Jiménez
authors.affiliation: Dept Bioscience, Aarhus University, Vejlsøvej 25, PO Box 314, Silkeborg 8600, Denmark. jsf@dmu.dk.
authors.forename: Janeck J
authors.initials: JJ
authors.lastname: Scott-Fordsmand
authors.affiliation: Centre for Human Exposure Science (CHES), Institute of Occupational Medicine (IOM), Edinburgh EH14 4AP, UK. Martie.VanTongeren@iom-world.org.
authors.forename: Martie
authors.initials: M
authors.lastname: van Tongeren
authors.affiliation: BASF SE, GB/TB-Z470, Ludwigshafen 67056, Germany. karin.wiench@basf.com.
authors.forename: Karin
authors.initials: K
authors.lastname: Wiench
authors.affiliation: BASF SE, GB/TB-Z470, Ludwigshafen 67056, Germany. wendel.wohlleben@basf.com.
authors.forename: Wendel
authors.initials: W
authors.lastname: Wohlleben
authors.affiliation: BASF SE, GB/TB-Z470, Ludwigshafen 67056, Germany. robert.landsiedel@basf.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Landsiedel
mesh_terms: D004777:Environment; D006801:Humans; D049329:Nanostructures / Q000633:toxicity*; D018570:Risk Assessment / Q000379:methods; D012449:Safety
keywords: MARINA risk assessment strategy; grouping; nanomaterials; read-across