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Administrative data

Key value for chemical safety assessment

Additional information

C10-C12 Aromatics are not mutagenic using in vitro or in vivo genotoxicity assays.  Further data derived from read across data from the supporting substance (structural analogue or surrogate), the C9 Aromatics also support the conclusion that C10-C12 Aromatics are not genotoxic. In bacterial reverse mutation tests, C10-C12 Aromatics were not mutagenic in the presence or absence of metabolic activation. Likewise, there were no mutagenic effects reported in a read-across in vitro mammalian gene mutation test (HGPRT forward mutation assay) in the supporting substance, C9 Aromatics. No in vitro chromosomal effects were reported in a Chinese hamster ovary assay that examined the C9 Aromatics. The test substance, C10-C12 Aromatics, did not produce chromosomal effects when tested in an in vivo mouse bone marrow micronucleus assay. Likewise, the supporting substance 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 C9 aromatics or the C10-C12 Aromatics. All studies were conducted in a manner similar or equivalent to currently established OECD guidelines.  C10-C12 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) - Read-Across from C9 Aromatics
Genetic Toxicity in vitro - In vitro Mammalian Cell Gene Mutation Test (OECD TG 476) - Read-Across from C9 Aromatics
Genetic Toxicity in vitro - In vitro Sister Chromatid Exchange Assay in Mammalian Cells (OECD TG 479) - Read-Across from C9 Aromatics

Genetic Toxicity in vivo - Micronucleus Assay in Mouse Bone Marrow (OECD TG 474)
Genetic Toxicity in vivo - Mammalian Bone Marrow Chromosome Aberration Test (OECD TG 475) - Read-Across from C9 Aromatics

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 C10-C12 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.