Registration Dossier

Toxicological information

Endpoint summary

Currently viewing:

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.