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:
A skin sensitization study performed according to Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406) found no indication of skin sensitization in guinea pigs for C10-C12 Aromatics. C10-C12 Aromatics are not skin sensitizers or photosensitizers in humans. C10-C12 Aromatics were evaluated for its ability to induce skin sensitization in a 100+ person Human Repeated Insult Patch Test (HRIPT). In addition, the ability to induce a phototoxic or photocontact response was determined by comparing irradiated and non-irradiated skin sites. C10-C12 Aromatics were applied to the skin of human volunteers under semi-occlusive dressing as a 30% w/w concentration in petrolatum. 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.

Migrated from Short description of key information:
C10-C12 Aromatics were negative using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406). C10-C12 Aromatics were negative in a Human Repeated Insult Patch Test (HRIPT).

Respiratory sensitisation

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

There are no reports of respiratory sensitization from C10-C12 Aromatics in laboratory animals or humans.  However, a skin sensitization study utilizing C10-C12 Aromatics 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 C10-C12 Aromatics will not be a respiratory sensitizing agent.


Migrated from Short description of key information:
no data

Justification for classification or non-classification

These findings do not warrant the classification of C10-C12 Aromatic 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.