Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
All genetic toxicity tests listed below had negative results for C9-C14 aliphatic, <2% aromatic hydrocarbons 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)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
All genetic toxicity tests listed below had negative results for C9-C14 aliphatic, <2% aromatic hydrocarbons fluids.
Genetic Toxicity in vivo – Micronucleus Assay in Mouse Bone Marrow (OECD TG 474)
Genetic Toxicity in vivo – Genetic Toxicology: Rodent Dominant Lethal Test (OECD TG 478)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
C9-C14 aliphatic, <2% aromatic hydrocarbons fluids are not mutagenic using in vitro or in vivo genotoxicity assays. In bacterial tests, C9-C14 aliphatic, <2% aromatic hydrocarbons fluids were not mutagenic in Salmonella strains tested in the presence or absence of metabolic activation. C9 -C14 aliphatic, <2% aromatic hydrocarbon fluids were negative in a in vitro mammalian cell gene mutation assay. In sister chromatid exchange and in chromosomal aberration studies, C9-C14 aliphatic, <2% aromatic hydrocarbons fluids did not produce an effect. C9-C14 aliphatic, <2% aromatic hydrocarbons 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. C9-C14 aliphatic, <2% aromatic hydrocarbons 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.
Justification for classification or non-classification
The negative results using in vitro and in vivo genotoxicity assays do not warrant the classification of C9-C14 aliphatic, <2% aromatic hydrocarbons 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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