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Toxicological information

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Administrative data

Description of key information

Skin sensitisation

C10-12 isoalkanes (<2% aromatics), C11-C14 n-alkanes (<2% aromatics) and C10-C13 (<2% aromatics) were not dermal sensitizers using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406).

Respiratory sensitisation

No data

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), C10-12 isoalkanes (<2% aromatics), C11-C14 n-alkanes (<2% aromatics) and C10-C13 (<2% aromatics) were not dermal sensitizers using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406). Moreover, in studies on human volunteers using C14-C20 aliphatics (<2% aromatics), there were no signs of irritation or sensitization effects of the test substances (IUCLID section 7.10.4).

Respiratory sensitisation

Endpoint conclusion
Additional information:

There are no reports of respiratory sensitization from C14-20 aliphatics (<2 % aromatics) in laboratory animals or humans. However, skin sensitization studies utilizing C9-14 aliphatics (<2 % aromatics) 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 C14-20 aliphatics (<2% aromatics) will not be a respiratory sensitizing agents.

Justification for classification or non-classification

These findings do not warrant the classification of C14-20 aliphatics (<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 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.