Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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 read-across substances to Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids. These substances are not skin sensitizers or photosensitizers in humans. Read-across substances to Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon 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. These read-across substances 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.

Migrated from Short description of key information:
Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, were determined not to be skin sensitizers using Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406). Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, were determined not to be skin sensitizers in Human Repeated Insult Patch Tests (HRIPT).

Respiratory sensitisation

Endpoint conclusion
Additional information:

There are no reports of respiratory sensitization from Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, in laboratory animals or humans.  However, skin sensitization studies utilizing read-across substances 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 Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, will not be a respiratory sensitizing agent.


Migrated from Short description of key information:
With observations from read-across studies in guinea pigs and humans, it is presumed that Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, will not be a respiratory sensitizing agent.

Justification for classification or non-classification

These findings do not warrant the classification of Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon 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.