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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The test substance l-Glutamic acid, N-coco acyl derivs., monosodium salts(CAS No. 68187-32-6) has been investigated for its sensitization potential in accordance with OECD guideline (Buehler protocol) under GLP conditions. For the induction phase undiluted material was used. During challenge 12 out of 20 animals reacted with distinct erythema. Therefore, a purified sample has been prepared for the re-challenge procedure. During re-challenge with the purified sample no skin reactions were observed after 24 and 48 hours in any animal.The registered substance is not considered to be sensitizing because the purification step is applied to all commercial material.

The study was conducted with a structurally similar substance, namely l-Glutamic acid, N-coco acyl derivs., monosodium salts(CAS No. 68187-32-6).Solubility, bioavailability and toxicity of the surrogates are not expected to differ from the registered substance as the target substance is the major component, and the central member of an homologous series of components, of the source substances, possessing identical functional groups and extremely similar structures. It is reasonable to expect that the toxicological properties of the target and source substances will not be markedly different. On this basis, experimental data on the source substances are expected to be directly applicable to the target substance, and can be used to adequately predict its properties. Further details are provided in the filed "attached document".

Migrated from Short description of key information:

Based on the findings in a non-adjuvant sensitization test in guinea pigs, the test item l-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS No. 68187-32-6) applied at a concentration of 50 % or 25 % in bi-distilled water is not classified and labelled as a skin sensitizer.

Justification for classification or non-classification

Based on skin sensitisation data available, the test item is not classified as skin sensitisitizer according to Regulation No (EC) 1272/2008 (CLP) and according to Directive 67/548/EEC (DSD) criteria.