Registration Dossier
Registration Dossier
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EC number: 692-840-5 | CAS number: 1345668-40-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, are not mutagenic using in vitro or in vivo genotoxicity assays. In bacterial tests, read-across substances were not mutagenic in Salmonella strains tested in the presence or absence of metabolic activation. These substances were negative in an in vitro mammalian cell gene mutation assay, sister chromatid exchange, and in chromosomal aberration studies. Read-across substances to Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, were also non-mutagenic when tested in an in vivo mouse bone marrow micronucleus assay and when tested in dominant lethal studies utilizing an inhalation route of exposure. All studies were conducted in a manner similar or equivalent to currently established OECD guidelines. Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, are a non-genotoxic agent and classification is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Short description of key information:
All genetic toxicity tests listed below had negative results for Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids.
Genetic Toxicity in vitro – Bacterial reverse mutation assay (OECD TG 471)
Genetic Toxicity in vitro – In vitro Mammalian Chromosome Aberration Test (OECD TG 473)
Genetic Toxicity in vitro - In vitro Mammalian Cell Gene Mutation Test (OECD TG 476)
Genetic Toxicity in vitro – Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells (OECD TG 479)
Genetic Toxicity in vivo – Micronucleus Assay in Mouse Bone Marrow (OECD TG 474)
Genetic Toxicity in vivo - Mammalian Bone Marrow Chromosome Aberration Test (OECD TG 475)
Genetic Toxicity in vivo – Genetic Toxicology: Rodent Dominant Lethal Test (OECD TG 478)
Genetic Toxicity in vivo - Mammalian Spermatogonial Chromosome Aberration Test (OECD TG 483)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The negative results using in vitro and in vivo genotoxicity assays do not warrant the classification of Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, as genotoxins under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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