Registration Dossier

Administrative data

Description of key information

Skin:

The test material was not irritating to the skin of the New Zealand White rabbit.

Eye:

The test material was found to be irritating to the eye of the New Zealand White rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin:

A study was performed to assess the irritancy potential of the test material l-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS No. 68187-32-6) to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion". A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema at two treated skin sites. All treated skin sites appeared normal seven days after treatment. The test material produced a primary irritation index of 0.5. No corrosive effects were noted. Therefore the test material was regarded as non-irritant.

Eye:

A study was performed to assess the irritancy potential of the test materiall-Glutamic acid, N-coco acyl derivs., monosodium salts(CAS No. 68187-32-6)to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion". A single instillation of the test material to the non-irrigated eye of three rabbits produced translucent or opalescent corneal opacity, iridial inflammation and severe conjunctival irritation. Other ocular effects noted were circumcorneal vascularisation, convoluted eyelids and dulling of the normal lustre of the corneal surface. The test material was classified as irritant.

The studies were 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".

Effects on eye irritation: irritating

Justification for classification or non-classification

No classification and labelling is required for skin irritation according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.

Based on eye irritation data available, the test item is classified as eye irrit. cat. 2 (H319: Causes serious eye irritation) according to Regulation No (EC) 1272/2008 (CLP) and as Xi; R36 Irritant; Irritating to eyes according to Directive 67/548/EEC (DSD) criteria.