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 dermal sensitization study was conducted with an unrefined light paraffinic distillate (CAS No. 64741-50-0) in Hartley albino guinea pigs (API, 1986a). The study was conducted in accordance with OECD Guideline 406. 

In this study, 0.4 millilitre of a 25% mixture of test material and paraffin oil (vehicle) was applied under an occlusive dressing to the shorn skin of 10 male and 10 female animals. The dressings were removed 6 hours after application, and the skin was wiped to remove residues of test material. The animals received one application each week for 3 weeks. The same application site was used each time. Two weeks following the third application, a challenge dose (0.4 millilitre of a 1% mixture in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. The application sites for sensitizing and challenge doses were read for erythema and oedema 24 and 48 hours after patch removal. To assist in the reading of the response to the final challenge dose the test site was depilated 3 hours prior to reading by using a commercially available depilatory cream. Positive control (i.e.,2,4-dinitrochlorobenzene at 0.3% in 80% aqueous ethanol), vehicle control and naive control groups were included in this study, and the procedure for these was the same as for the test groups.

Determination of sensitization was based upon reactions to the challenge dose. None of the animals in this study became sensitized following treatment with the test material when these results were compared to the negative control group. In contrast, all the positive control animals were sensitized by their treatment with 2,4-dinitrochlorobenzene.

Migrated from Short description of key information:

One key skin sensitisation study (OECD 406) was identified on unrefined light paraffinic distillate.  In this study, the test material was not sensitising to Hartley albino guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Respiratory sensitisation is not a standard information requirement.

Migrated from Short description of key information:

No data identified.

Justification for classification or non-classification

Using information from a key skin sensitisation study, unrefined/acid treated oils are not considered to be skin sensitizers. Therefore, unrefined/acid treated oils do not the criteria for classification as a dermal sensitizer under the EU CLP Regulation (EC No. 1272/2008). There is no data available for respiratory sensitisation.