Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

1. Literature

According to the literature that was investigated by THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS (SCCNFP) a clear sensitizing potential can not be derived for Acetaldehyde. The SCCNFP presented a modified Cumulative Contact Enhancement Tests (CCET) with positive result and human data that does not justify classification as human sensitizer.

2.Additonal results

In order to assess the cutaneous allergenic potential of acetaldehyde, the Guinea Pig Maximization Test according to OECD 406 was carried out in 30 female guinea pigs. The intradermal induction of sensitisation was performed with 5% dilution of Acetaldehyde in acetone and in an emulsion of Freund's Complete Adjuvant/physiological saline . The epidermal induction of sensitization was conducted under occlusion with acetaldehyde at 50% in acetone. Two weeks after the epidermal induction application the callenge was completed by epidermal application of the test item at 25% in acetone under occlusive dressing. The animal of the control group were induced with acetone and Freund's Complete Adjuvant/physiological saline and callenged similarly to those of the test group. Cutaneous reactions, ie erythema and eschar, as well as oedema formation were evaluated at 24 and 48 hours after the removal of the dressing. Neither the test group nor the control group erythematous reactions were obsered. The positve control group that was treated with the known sensitizer alpha-Hexylcinnamaldehyde did show the expected reaction from slight to severe edemas. Therefore, acetaldehyde is considered not to be a sensitizer under the conditions of the test.

Conlusion

Based on the currently available data acetaldehyde should not be classified as human sensitizer.

Justification for classification or non-classification