Registration Dossier

Toxicological information

Carcinogenicity

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Description of key information

The available data and available weight of evidence demonstrate that the Hydrocarbons, C7-C9 aliphatics are highly unlikely to be carcinogenic and are not classifiable as carcinogens.

Key value for chemical safety assessment

Additional information

The available data and available weight of evidence demonstrate that the substances in this category are highly unlikely to be carcinogenic and are not classifiable as carcinogens. Further testing is not required under Annex XI, section 1.2.

No standard carcinogenicity studies are available for substances in the C7-C9 aliphatic hydrocarbons category. However, with regard to the molecular structure of the substances within the category no carcinogenic potential is expected. Moreover, in investigations with various substances of the category on mutagenicity (in vitro and in vivo) as well as in repeated dose toxicity studies (oral route and via inhalation), neither genotoxicity nor an indication for neoplastic lesions was observed. In addition, all substances within the category contain benzene levels below 0.01%.

Justification for classification or non-classification

These findings do not warrant the classification of Hydrocarbons, C7-C9 aliphatics as a carcinogen 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.