Registration Dossier

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.