Registration Dossier

Administrative data

Description of key information

The test material was considered to be a non-sensitiser under the conditions of the in vivo study in accordance with EU criteria.

Key value for chemical safety assessment

Skin sensitisation

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

Skin sensitisation (in vitro)

In vitro skin sensitisation studies are not required because adequate data from an in vivo skin sensitisation study is available. The in vivo studies are considered to be reliable and were conducted before the amendment of the REACH annex for the consideration of in chemico or in vitro skin sensitisation assays.

Skin sensitisation (in vivo)

The potential of the test material to act as a sensitiser was investigated in a GLP study in accordance with the standardised guidelines OECD 406, EU Method B.6 and US EPA OPPTS 870.2600.

After induction of 20 guinea-pigs by 3 topical applications with the test material applied diluted at 10 % in liquid paraffin under occlusive dressing and a 13-day rest phase, the challenge phase, under occlusive dressing for 6 hours, consisted of a single topical application of the test material at 5 % in liquid paraffin and of a negative control (liquid paraffin). The concentration selected for the induction phase and the challenge based on the result of a pre-test. Readings were performed 24, 48 and 72 hours after removal of the patches.

In the treated group (treatment concentration of 5 %), a discrete erythema in 25 % (5/20) and 5 % (1/20) of the animals at 24 and 48 hours after the challenge phase, respectively, was recorded. No cutaneous reaction was recorded at 72 hours. In the control group (associated with the treatment concentration of 5 %), a discrete erythema in 10 % (1/10) of the animals at 24 hours after the challenge was recorded. No cutaneous reaction was recorded at 48 and 72 hours. As irritation was observed in the control group animals, only reactions in the test group animals that exceeded the most severe reactions seen in the control group animals were attributed to skin sensitization. So, a sensitization reaction was noted in 5 % (1/20) of the animals from the treated group, 48 hours after the challenge phase, on the area challenged with the test material at 5 %. In the treated group on the treated area with liquid paraffin, no macroscopic cutaneous reaction attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase). No cutaneous reaction was recorded in animals from the control groups after the challenge phase, on the treated area with liquid paraffin (control material). In view to confirm or infirm these results, a second challenge phase was performed under the same experimental conditions with a new negative control group after a rest phase of 7 days. In the treated group (treatment concentration of 5 %), no macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (rechallenge phase). In the control group (associated with the treatment concentration of 5 %), no cutaneous intolerance reaction was observed during the examination following the removal of the occlusive dressing. In the treated group on the treated area with liquid paraffin, no macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (rechallenge phase). No cutaneous reaction was recorded in animals from the control groups after the rechallenge phase, on the treated area with liquid paraffin (control material).

In conclusion, the test material was considered to be a non-sensitiser under the conditions of this study in accordance with EU criteria.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin sensitization.