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.
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406), C11-C14, n-alkanes (<2% aromatics) and C10-C13, n-alkanes (<2% aromatics) were not dermal sensitizers . Moreover, in studies on human volunteers using C5-C20, n-alkanes (<2% aromatics), there were no signs of irritation or sensitization effects of the test substances (IUCLID section 7.10.4). Consequently, Paraffins (petroleum), normal C>10, is not skin sensitisating.
Migrated from Short description of key information:
As C11-C14, n-alkanes (<2% aromatics) and C10-C13, n-alkanes (<2% aromatics) were not dermal sensitizers using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406), Paraffins (petroleum), normal C>10 is also not expected to cause skin sensitisation.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
There are no reports of respiratory sensitization from the categories C9 -14 aliphatics (<2 % aromatics) and C14 -C20 aliphatics (<2% aromatics) in laboratory animals or humans. However, skin sensitization studies utilizing these two categories found no indication of skin sensitization in guinea pigs. Additional studies on C14-C20 aliphatics (<2% aromatics) in humans also found no indication of skin sensitization. With these observations, it is presumed that the two categories C9 -C14 aliphatics and C14 -C20 aliphatics as for C10 -C17, (<2% aromatics) will not be a respiratory sensitizing agents.
Justification for classification or non-classification
These findings do not warrant the classification of C10 -17, n-alkanes (<2 % aromatics) hydrocarbon solvents as a skin or respiratory sensitizer under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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