Registration Dossier
Registration Dossier
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EC number: 232-395-2 | CAS number: 8013-75-0 A combination of amyl alcohols, primarily isoamyl alcohol and 2-methyl-1-butanol. Other alcohols, acids, esters and aldehydes may also be present.
Carcinogenicity
Administrative data
Description of key information
Based on all available data of the main constituents of Fusel oil, the weight of evidence demonstrates that the substances seem highly unlikely to be carcinogenic and are not classifiable as carcinogens. Further testing is not required under Regulation (EC) 1907/2006, Annex XI, section 1.2.
Key value for chemical safety assessment
Justification for classification or non-classification
Based on all available data of the main constituents of Fusel oil, it is expected that Fusel oil has no carcinogenic potential. The available data do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
Additional information
No carcinogenicity study is available with the target substance Fusel Oil. Fusel oil is a complex mixture of alcohols, aldehydes, esters and other substances. For assessment of human health the main constituents, occurring at amounts of ≥ 10%, were evaluated. These are ethanol (CAS No. 64-17-5), 3-methylbutan-1-ol (CA 123-51-3), 2-methylbutan-1-ol (CAS No. 137-32-6), and 2-methylpropan-1-ol (CAS No. 78-83-1).The main constituents of Fusel oil are of low concern with regard to systemic toxicity. Available studies via the oral, dermal and intraperitoneal route indicate low acute and repeated dose toxicity ofethanol, 3-methylbutan-1-ol, 2-methylbutan-1-ol, and 2-methylpropan-1-ol. None of the 4 substances was mutagenic or clastogenic in the available genetic toxicity studies. They bear no structural similarity to known carcinogens, have no functional groups associated with carcinogenicity and did not produce evidence of neoplasia in repeated dose toxicity studies. Therefore it is concluded that the category members do not possess a carcinogenic potential.
QSAR data for 2-methylpropan-1-ol (CAS No. 78-83-1) reveal no carcinogenic potential based on its chemical structure (Rosenkranz and Klopman, 1990).
Available data for ethanol indicate that there is inadequate evidence for the carcinogenicity of ethanol in experimental animals (OECD, 2004). In addition, human data on ethanol exposure and consumption are available. The International Life Sciences Institute (OECD, 2004) has published an extensive review of the health issues relating to alcohol consumption. They concluded that ethanol is not a carcinogen by standard laboratory tests. Such tests are the normal measure for the assessment of industrial chemicals and any chemical that would be expected to present a carcinogenic hazard to workers or consumers during normal handling and use would be expected to show a positive result in one or more of such tests.
It is therefore concluded that Fusel oil possesses no carcinogenic potential.
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