Registration Dossier

Administrative data

Description of key information

Skin irritation: The test material was found to be non-irritating to human skin at concentrations of 2, 6 and 12% in EtOH/DEP 1:1, single application patch test under occlusion, Küster & Goluchowski (1999)

Skin sensitisation: Not sensitising at concentrations of 8 and 15 % in EtOH/DEP 1:1 in a human repeat insult patch test under occlusive conditions, Middeke & Küster (2000)

Skin sensitisation: Not sensitising in a human maximisation test, Kligman (1975)

Additional information

The skin irritation potential of the test material was assessed in 50 human volunteers using a single application patch test. Test material at concentrations of 2, 6 and 12% in EtOH/DEP 1:1 was applied to the back of each volunteer under occlusive cutaneous test plasters. After a test period of 48 hours the test plasters were removed and the test area was assessed. Further assessments were performed after 72 and 96 hours. With the exception of two slight reactions noted in the 2% product, the test material was found to be well tolerated by the skin under the conditions of the study.

The skin sensitisation potential of hexenyl-3-cis salicylate was assessed in 50 volunteers using repeated application closed patch epicutaneous testing under occlusion. Informed written consent was sought prior to study initiation. The test material was found to be very well tolerated by the skin under the conditions of the test at 8% and 15% concentrations in EtOH/DEP 1:1.

Supporting information on the skin sensitisation potential of the test material, in humans, is available in the form of a report by Kligman (1975). The report documents results of a patch test during which the test material was applied under occlusion to the forearms of 25 adult volunteers for five alternate day 48 hour periods. The patch sites was pre-treated for 24 hours with 5% aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter. Under the conditions of the study, there were no instances of contact-sensitisation from the test material on the Maximisation Test. It is unlikely that this test material would present a danger of contact-sensitisation in normal, intended use.

All studies were presented in a sufficient level of detail to assess accuracy of the conclusions presented. All studies were performed in line with good scientific principles. The data were therefore all assigned a reliability score of 2 in accordance with the principles for assessing data quality described by Klimisch (1997).