Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

C9-14 Aliphatics (2-25% Aromatics) are not mutagenic using in vitro or in vivo genotoxicity assays.  Further data derived from read across data from the supporting substances (structural analogue or surrogate), kerosene and jet fuel, also support the conclusion that C9-14 Aliphatics (2-25% Aromatics) are not genotoxic. In bacterial reverse mutation tests, C9-14 Aliphatics (2-25% Aromatics) were not mutagenic in the presence or absence of metabolic activation. Likewise, there were no mutagenic effects reported in an in vitro mammalian gene mutation test (HGPRT forward mutation assay). No in vitro chromosomal effects were reported in a Chinese hamster ovary assay that examined hydrodesufurized kerosene. The test substance, C9-14 Aliphatics (2-25% Aromatics), did not produce chromosomal effects when tested in an in vivo mouse bone marrow micronucleus assay.  These data demonstrate that these substances are not categorizable genotoxins either in vitro or in vivo. Furthermore, no there evidence of hyperplastic responses or pre-neoplastic lesions in sub-chronic and chronic repeat-dose studies in C9-14 Aliphatics (2-25% Aromatics). All studies were conducted in a manner similar or equivalent to currently established OECD guidelines.  C9-14 Aliphatics (2-25% Aromatics) are a non-genotoxic agent and classification is not warranted.


Short description of key information:
Genetic Toxicity in vitro - Negative - Bacterial reverse mutation assay (OECD TG 471)
Genetic Toxicity in vitro - Negative - In vitro Mammalian Chromosome Aberration Test (OECD TG 473)
Genetic Toxicity in vitro - Negative - In vitro Mammalian Cell Gene Mutation Test (OECD TG 476)
Genetic Toxicity in vitro - Negative - In vitro Sister Chromatid Exchange Assay in Mammalian Cells (OECD TG 479) - Read-Across from Hydrodesulfurized Kerosene

Genetic Toxicity in vivo - Negative - Micronucleus Assay in Mouse Bone Marrow (OECD TG 474) - Read-Across from Jet Fuel A
Genetic Toxicity in vivo - Negative - Mammalian Bone Marrow Chromosome Aberration Test (OECD TG 475)

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 C9-14 Aliphatics (2-25% Aromatics) 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.