N-[3-(dimethylamino)propyl]oleamide

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Additional information:

The test substance Trennmittel ZM 121 was tested for a possible allergenic activity after intradermic injection and topical administration in guinea pigs. The study was conducted according to OECD guideline 406. 11 animals were induced with an intradermic injection of 0.3906% and a topical application of 100% of the test item. After a 10-day rest phase, they were challenged by a single application of the test item at 1.5625% and 0.7813% for 24 hours. 48 hours after the challenge phase, significant macroscopic cutaneous reactions were registered in 100% of the animals (11/11) at both application sites. No cutaneous intolerance reaction was recorded in animals from the negative control group.

In addition to the animal study, human data concerning the sensitizing potential of the test substance. A few clinical case descriptions (De Groot et al., 1984) and a number of clinical studies (De Groot et al., 1988; Bruynzeel et al., 1992; Foti et al., 1995) have been published which describe allergic skin reactions to cosmetics containing the test substance and the test substance itself, respectively.

In 1984, three cases of female patients were reported (De Groot et al., 1984), who had previously shown cutaneous reactions to cosmetics containing oleamidopropyl dimethylamine. In a patch test, clear positive reactions were observed in all three women at 0.5% of oleamidopropyl dimethylamine phosphate in water 72 hours after application of the patches. Positive reactions were in part detected at lower concentrations and after shorter observation periods.

Patch tests in larger populations of of patients were performed in three published clinical studies. Bruynzeel et al. (1992) reported allergic skin reactions to oleamidopropyl dimethylamine in 6.1% (3/44) of the patients when applied at 0.3%, in 12.2% (6/44) when applied at 0.2%, and in 4.5% (2/44) when applied at 0.1%. 4.9% (14/285) of the patients examined in a study by Foti et al. (1995) showed allergic skin reactions to oleamidopropyl dimethylamine. In a study by de Groot et al. (1988), 13 patients with a known allergy to a cosmetic containing 0.3% oleamidopropyl dimethylamine were treated with the substance itself and a series of 11 other surfactants to examine its cross-reaction pattern. Oleamidopropyl dimethylamine alone caused skin sensitization in all 13 patients when applied in the course of a patch test.

It can be concluded that under the experimental conditions chosen, the test item Trennmittel ZM 121 caused skin sensitisation in the guinea pig maximization test. Based on the results of the study, the test substance needs to be classified as a category 1A skin sensitiser (H317 - May cause allergic skin reactions) according to Regulation (EC) No 1272/2008 (CLP).

Migrated from Short description of key information:
The test substance caused skin sensitisation in the guinea pig maximization test (according to OECD guideline 406). Based on the results of the study, the test substance needs to be classified as a category 1A skin sensitiser (H317 - May cause allergic skin reactions) according to Regulation (EC) No 1272/2008 (CLP).

Justification for classification or non-classification

Regulation (EC) No 1272/2008 (CLP) recommends classification as a Category 1A skin irritant if >=60% of the treated animals show cutaneous reactions at an intradermal induction dose of >0.1% and <=1%. 48 hours after the challenge phase in the present study, the test item caused skin reactions in 100% of the test animals at an intradermal induction dose of 0.3906% 48 hours. Based on these results, it is suggested that the test substance be classified as a category 1A skin sensitiser (H317 - May cause allergic skin reactions) according to Regulation (EC) No 1272/2008 (CLP).