Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Hydrocarbons, C9 aromatics are not mutagenic using in vitro or in vivo genotoxicity assays.  In bacterial reverse mutation tests, Hydrocarbons,C9 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 the Hydrocarbons, C9 aromatics. The Hydrocarbons, C9 aromatics, were not clastogenic in an in vivo mammalian bone marrow chromosome aberration test. 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 either the Hydrocarbons, C9 aromatics. All studies were conducted in a manner similar or equivalent to currently established OECD guidelines.  Hydrocarbons, C9 aromatics are a non-genotoxic agent and classification is not warranted.


Short description of key information:
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 - In vitro Sister Chromatid Exchange Assay in Mammalian Cells (OECD TG 479)

Genetic Toxicity in vivo - 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 Hydrocarbons,C9,aromatics 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.