Registration Dossier

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:

A Mouse Local Lymph Node Assay (LLNA) was performed to assess the skin sensitisation potential of beta-alanine in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following: OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002), and Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008. Following a preliminary screening test in which no clinical signs of toxicity were noted at a maximum attainable concentration of 10% w/w in ethanol/distilled water 7:3, this concentration was selected as the highest dose investigated in the main test of the LLNA. Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test material as a solution in ethanol/distilled water 7:3 at concentrations of 10%, 5% or 2.5% w/w. A further group of four animals was treated with ethanol/distilled water 7:3 alone. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows: 0.86, 0.43, and 1.32 at concentrations of 2.5, 5, and 10% respectively. The test material was considered to be a non-sensitiser under the conditions of the test.

 


Migrated from Short description of key information:
Mouse Local Lymph Node Assay (LLNA): OECD TG 429 and Method B42 of Commission Regulation (EC) No. 440/2008: negative

Justification for classification or non-classification

On the basis of the test results, beta-alanine has not to be classified for skin sensitisation according to DSD and CLP criteria.