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Adapting the in vitro micronucleus assay (OECD Test Guideline No. 487) for testing of manufactured nanomaterials: recommendations for best practices.
Burgum, Michael J; Ulrich, Clarissa; Partosa, Natascha; Evans, Stephen J; Gomes, Caroline; Seiffert, Svenja Berit; Landsiedel, Robert; Honarvar, Naveed; Doak, Shareen H.
Afiliação
  • Burgum MJ; In Vitro Toxicology Group, Faculty of Medicine, Health and Life Sciences, Institute of Life Sciences, Swansea University Medical School, Singleton Park, Swansea, SA2 8PP, Wales, United Kingdom.
  • Ulrich C; BASF SE, Experimental Toxicology and Ecology, 67056, Ludwigshafen, Germany.
  • Partosa N; BASF SE, Experimental Toxicology and Ecology, 67056, Ludwigshafen, Germany.
  • Evans SJ; In Vitro Toxicology Group, Faculty of Medicine, Health and Life Sciences, Institute of Life Sciences, Swansea University Medical School, Singleton Park, Swansea, SA2 8PP, Wales, United Kingdom.
  • Gomes C; BASF SE, Experimental Toxicology and Ecology, 67056, Ludwigshafen, Germany.
  • Seiffert SB; BASF SE, Analytical and Material Science, 67056, Ludwigshafen, Germany.
  • Landsiedel R; BASF SE, Experimental Toxicology and Ecology, 67056, Ludwigshafen, Germany.
  • Honarvar N; Free University of Berlin, Pharmacy - Pharmacology and Toxicology, 14195 Berlin, Germany.
  • Doak SH; BASF SE, Experimental Toxicology and Ecology, 67056, Ludwigshafen, Germany.
Mutagenesis ; 39(3): 205-217, 2024 Apr 24.
Article em En | MEDLINE | ID: mdl-38502821
ABSTRACT
The current Organisation for Economic Co-Operation and Development test guideline number 487 (OECD TG No. 487) provides instruction on how to conduct the in vitro micronucleus assay. This assay is one of the gold standard approaches for measuring the mutagenicity of test items; however, it is directed at testing low molecular weight molecules and may not be appropriate for particulate materials (e.g. engineered nanoparticles [ENPs]). This study aimed to adapt the in vitro micronucleus assay for ENP testing and underpins the development of an OECD guidance document. A harmonized, nano-specific protocol was generated and evaluated by two independent laboratories. Cell lines utilized were human lymphoblastoid (TK6) cells, human liver hepatocytes (HepG2) cells, Chinese hamster lung fibroblast (V79) cells, whole blood, and buffy coat cells from healthy human volunteers. These cells were exposed to reference ENPs from the Joint Research Council (JRC) SiO2 (RLS-0102), Au5nm and Au30nm (RLS-03, RLS-010), CeO2 (NM212), and BaSO4 (NM220). Tungsten carbide-cobalt (WC/Co) was used as a trial particulate positive control. The chemical controls were positive in all cell cultures, but WC/Co was only positive in TK6 and buffy coat cells. In TK6 cells, mutagenicity was observed for SiO2- and both Au types. In HepG2 cells, Au5nm and SiO2 showed sub-two-fold increases in micronuclei. In V79 cells, whole blood, and buffy coat cells, no genotoxicity was detected with the test materials. The data confirmed that ENPs could be tested with the harmonized protocol, additionally, concordant data were observed across the two laboratories with V79 cells. WC/Co may be a suitable particulate positive control in the in vitro micronucleus assay when using TK6 and buffy coat cells. Detailed recommendations are therefore provided to adapt OECD TG No. 487 for testing ENP.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Testes para Micronúcleos Limite: Animals / Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Testes para Micronúcleos Limite: Animals / Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article