Registration Dossier

Administrative data

Description of key information

Skin sensitisation (OECD 406): not sensisiting

Key value for chemical safety assessment

Skin sensitisation

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

Regarding skin sensitisation a reliable study is available. A study for respiratory sensitisation potential is not available.

The skin sensitising potential of the test substance was investigated in a guinea pig maximisation test (GPMT test) performed according to OECD Guideline 406 and in compliance with GLP (M-072614-01-2). 30 female Crl:HA guinea pigs were used (20 animals as test group, 10 animals as control group) to evaluate skin sensitising effects. The test material was formulated in physiological saline. The induction and challenge concentrations were determined in a range-finding study. The intradermal induction was conducted by administration of three pairs of injections. The first pair of injections was of Freund's complete adjuvant (FCA) diluted 1:1 in physiological saline, the second pair was of 5% of the test substance, and the third pair of injections was of 5% of the test substance with FCA. The control group received three pairs of injections that were the same as the test group except for the absence of the test material. One week following intradermal induction the hair of the test area was shorn and another one day later an epicutaneous induction under occlusive conditions for 48 h was performed. For the test group, the patches contained 0.5 mL of a 6% test substance solution in physiological saline, while for the control group the patches contained only physiological saline. Three weeks after the intradermal induction the dorsal area and right flank of all animals was shorn and another one day later the animals were challenged with 3% of the test substance under occlusive conditions for 24 h. Patches placed on the flank contained physiological saline as control. Skin reactions were evaluated at 48 and 72 h after the beginning of the challenge period. In addition, clinical signs were noted at least once daily throughout the duration of the experiment and body weights were measured prior to the first induction, and at the end of the study.

Positive control studies were conducted on a regular basis using alpha hexyl cinnamic aldehyde in PEG400, at concentrations of 5% for intradermal induction, 25% for topical induction, and 12% for challenge. In the iteration applicable to the current study, 100% of the animals challenged exhibited dermal reactions, while there were no reactions observed in the negative control group animals.

One animal in the test item group showed clinical signs during day 10 to day 14 (poor general condition, piloerection, labored breathing, and pallor), and died on day 15. There were no other clinical signs or body weight differences between the treated and control animals observed. In both the control and the test group, wheals and encrustations were noted after the intradermal induction. There were no reactions after topical administration and no reactions to dermal challenge administration of the test substance noted in either control or test animals.

The test material was evaluated as not skin sensitising under the conditions of this test.

Justification for classification or non-classification

The available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.