Registration Dossier
Registration Dossier
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EC number: 265-232-9 | CAS number: 64771-71-7 A combination of normal paraffins having carbon numbers predominantly greater than C10 obtained by urea adduction or molecular sieve processes.
Carcinogenicity
Administrative data
Description of key information
The available data demonstrate that the Paraffins (petroleum), normal C>10 are highly unlikely to be carcinogenic and are not classified as carcinogens.
Key value for chemical safety assessment
Justification for classification or non-classification
These findings do not warrant the classification of Paraffins (petroleum), normal C>10 as a carcinogen under the CLP Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures or under the Directive 67/548/EEC for dangerous substances.
Additional information
The objective of the two performed studies was to investigate the promoter activity of the substance C10 -C13, n-alkanes, <2% aromatics in a dermal carcinogenicity model.
The tumor promotion activity was greatest in the treated groups displaying the highest degree of dermal irritation, 100% C10 -C13, n-alkanes, <2% aromatics. A low tumor incidence occurred in the groups receiving 50% or 28.6% of C10 -C13, n-alkanes (1 squamous-cell carcinoma and 3 papillomas, respectively), which had low degrees of dermal irritation. However, the tumor incidence and estimated time to tumor of these two groups was not significantly different from the initiated carrier control group. The promotional activity is a secondary conveyance of repeated skin irritation.
The results of the initiator/promoter test indicate that C10 -C13, n-alkanes, <2% aromatics is a possible skin tumor promoter, but only when there is a high degree of skin irritation and repeated dermal irritation.
Based on these results, the substance Paraffins (petroleum), normal C>10 is not expected to have carcinogenic effects.
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