Registration Dossier

Administrative data

Description of key information

-A primary skin irritation study in rabbits was conducted with beta-alanine (4 hour-exposure, according to OECD TG 404, Draize scheme; GLP): beta-alanine is not a skin irritant.
-In an eye irritation study (equivalent to OECD TG 405; GLP, Draize score): β-alanine is not irritating to the eyes

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:
no adverse effect observed (not irritating)

Additional information

A GLP study was performed to assess the irritation potential of beta-alanine to the skin of 2 New Zealand White rabbits. The method was designed to meet the following requirements: OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002); Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008. A single 4-hour semi-occluded application of the test material to the intact skin of two rabbits produced no evidence of skin irritation. No corrosive effects were noted. The test material produced erythema score and oedema scores of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. 

In order to assess the irritancy potential of the test material an in vivo eye irritation test was performed on 2 New Zealand White rabbits. The study was method was designed to meet the requirements of the following: OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002); Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008. A volume of 0.1mL of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The application of the test material to the non-irrigated eye of two rabbits produced moderate conjunctival redness (Draize Score 1 for 1 animal and 2 for the second animal), which was reversible with 48 hours.

Justification for classification or non-classification

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