title: Case studies putting the decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping) into practice.
abstract: Case studies covering carbonaceous nanomaterials, metal oxide and metal sulphate nanomaterials, amorphous silica and organic pigments were performed to assess the Decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping). The usefulness of the DF4nanoGrouping for nanomaterial hazard assessment was confirmed. In two tiers that rely exclusively on non-animal test methods followed by a third tier, if necessary, in which data from rat short-term inhalation studies are evaluated, nanomaterials are assigned to one of four main groups (MGs). The DF4nanoGrouping proved efficient in sorting out nanomaterials that could undergo hazard assessment without further testing. These are soluble nanomaterials (MG1) whose further hazard assessment should rely on read-across to the dissolved materials, high aspect-ratio nanomaterials (MG2) which could be assessed according to their potential fibre toxicity and passive nanomaterials (MG3) that only elicit effects under pulmonary overload conditions. Thereby, the DF4nanoGrouping allows identifying active nanomaterials (MG4) that merit in-depth investigations, and it provides a solid rationale for their sub-grouping to specify the further information needs. Finally, the evaluated case study materials may be used as source nanomaterials in future read-across applications. Overall, the DF4nanoGrouping is a hazard assessment strategy that strictly uses animals as a last resort.
authors.affiliation: AkzoNobel NV, Arnhem, The Netherlands.
authors.forename: Josje H E
authors.initials: JH
authors.lastname: Arts
authors.affiliation: BASF SE, Ludwigshafen, Germany.
authors.forename: Muhammad-Adeel
authors.initials: MA
authors.lastname: Irfan
authors.affiliation: Afton Chemical, Richmond, VA, USA.
authors.forename: Athena M
authors.initials: AM
authors.lastname: Keene
authors.affiliation: Clariant Produkte GmbH, Sulzbach, Germany.
authors.forename: Reinhard
authors.initials: R
authors.lastname: Kreiling
authors.affiliation: Shell Health, Shell Oil Company, Houston TX, USA.
authors.forename: Delina
authors.initials: D
authors.lastname: Lyon
authors.affiliation: Evonik Resource Efficiency GmbH, Hanau, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Maier
authors.affiliation: Henkel AG & Co. KGaA, Düsseldorf, Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Michel
authors.affiliation: BASF SE, Ludwigshafen, Germany.
authors.forename: Nicole
authors.initials: N
authors.lastname: Neubauer
authors.affiliation: Toxminds BVBA, Brussels, Belgium.
authors.forename: Thomas
authors.initials: T
authors.lastname: Petry
authors.affiliation: Scientific Consultancy - Animal Welfare, Neubiberg, Germany.
authors.forename: Ursula G
authors.initials: UG
authors.lastname: Sauer
authors.affiliation: The Chemours Company, Wilmington DE, USA.
authors.forename: David
authors.initials: D
authors.lastname: Warheit
authors.affiliation: BASF SE, Ludwigshafen, Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Wiench
authors.affiliation: BASF SE, Ludwigshafen, Germany.
authors.forename: Wendel
authors.initials: W
authors.lastname: Wohlleben
authors.affiliation: BASF SE, Ludwigshafen, Germany. Electronic address: robert.landsiedel@basf.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Landsiedel
mesh_terms: D000818:Animals; D019985:Benchmarking; D002478:Cells, Cultured; D003661:Decision Support Techniques; D006801:Humans; D053768:Metal Nanoparticles / Q000737:chemistry / Q000145:classification / Q000633:toxicity*; D009152:Mutagenicity Tests; D037742:Nanotubes, Carbon / Q000737:chemistry / Q000145:classification / Q000633:toxicity*; D019055:No-Observed-Adverse-Effect Level; D010316:Particle Size; D018570:Risk Assessment; D012995:Solubility; D013499:Surface Properties; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards; D057188:Workflow
chemical_list: D037742:Nanotubes, Carbon
keywords: Amorphous silica nanomaterials; Apical toxic effects; Biopersistence and biodistribution; Carbonaceous nanomaterials; Cellular effects; Grouping; Intrinsic material and system-dependent properties; Metal oxide and metal sulphate nanomaterials; Organic pigments; Read-across