Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

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.


Short 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)
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: 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 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.