Reaction mass of N, N'-hexane-1,6-diylbis [12-hydroxyoctadecanamide] and 12-hydroxy-N-[6-[1-oxoalkyl)amino] hexyl ] octadecanamide

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In a study performed according to OECD 429, EC B.42 and EPA guidelines, mice were exposed to up to 25% of AD-1000 on three consecutive days. The irritation of the ears as shown by the animals was similar in frequency within all groups and was considered not to have a toxicologically relevant effect on the activity of the nodes. All nodes of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant. No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study. The SI values calculated for the substance concentrations 5, 10 and 25% were 1.5, 1.8 and 1.9, respectively. There was no indication that the test substance could elicit a SI >=3. It was established that the EC3 value (if any) exceeds 25%. The six-monthly reliability check with alpha-hexylcinnamic aldehyde indicates that the Local Lymph Node Assay as performed at the test laboratory is an appropriate model for testing for contact hypersensitivity.

Migrated from Short description of key information:
In a skin sensitisation study (LLNA) with AD-1000 according to current test guidelines, no skin sensitisation was observed.

Justification for classification or non-classification

Based on the study present, AD-1000 does not have to be classified according to 67/548/EEC and the CLP Regulation (EC) No 1272/2008 for skin sensitisation.