Registration Dossier
Registration Dossier
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EC number: 694-876-7 | CAS number: 1345668-41-8
Carcinogenicity
Administrative data
Description of key information
The available data and available weight of evidence demonstrate that Distillates (Fischer-Tropsch), C8-C10-branched and linear, is highly unlikely to be carcinogenic and is not classifiable as a carcinogen. However, It should be noted that, although the data do not support classification of the registered substance per se for carcinogenic potential, there is a regulatory requirement to classify substances containing >0.1% benzene as carcinogenic.
Key value for chemical safety assessment
Justification for classification or non-classification
These findings do not warrant the classification of Distillates (Fischer-Tropsch), C8-C10-branched and linear, 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. However, it should be noted that, although the data do not support classification of the registered substance per se for carcinogenic potential, there is a regulatory requirement to classify substances containing >0.1% benzene as carcinogenic.
Additional information
The available data and available weight of evidence demonstrate that Distillates (Fischer-Tropsch), C8-C10-branched and linear, is highly unlikely to be carcinogenic and is not classifiable as a carcinogen. However, it should be noted that, although the data do not support classification of the registered substance per se for carcinogenic potential, there is a regulatory requirement to classify substances containing >0.1% benzene as carcinogenic. Further testing is not required under Annex XI, section 1.2.
No standard carcinogenicity studies are available for Distillates (Fischer-Tropsch), C8-C10-branched and linear. In investigations with various read across substances 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.
Read across justification is provided in the Read Across Document attached to Section 13.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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