Registration Dossier

Administrative data

Description of key information

C9-C14 aliphatic, < 2% aromatic hydrocarbons fluids were determined not to be skin sensitizers using Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406).  C9-C14 aliphatic, <2% aromatic hydrocarbons fluids were determined not to be skin sensitizers in Human Repeated Insult Patch Tests (HRIPT).

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization studies performed according to Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406) found no indication of skin sensitization in guinea pigs for C9-C14 aliphatic, <2% aromatic hydrocarbons fluids. C9-C14 aliphatic, <2% aromatic hydrocarbons fluids are not skin sensitizers or photosensitizers in humans. C9-C14 aliphatic, <2% aromatic hydrocarbons fluids were evaluated for the ability to induce skin sensitization in Human Repeated Insult Patch Tests (HRIPT). In addition, the ability to induce a phototoxic or photo-contact response was determined by comparing irradiated and non-irradiated skin sites. C9-C14 aliphatic, <2% aromatic hydrocarbons fluids were applied to the skin of human volunteers under semi-occlusive dressing. Application to the skin without or in conjunction with UV irradiation did not elicit a sensitizing or photosensitizing response in any of the study participants.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitization from C9-C14 aliphatic, <2% aromatic hydrocarbons fluids in laboratory animals or humans.  However, skin sensitization studies utilizing C9-C14 aliphatic, <2% aromatic hydrocarbons fluids found no indication of skin sensitization in guinea pigs.  Additional studies in humans also found no indication of skin sensitization. With these observations, it is presumed that C9-C14 aliphatic, <2% aromatic hydrocarbons fluids will not be a respiratory sensitizing agent.

Justification for classification or non-classification

These findings do not warrant the classification of C9-C14 aliphatic, <2% aromatic hydrocarbons fluids 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.