Registration Dossier

Administrative data

Description of key information

-Repeated dose toxicity: oral (GLP, OECD TG 407), NOAEL=1000 mg/kg bw/day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day

Mode of Action Analysis / Human Relevance Framework

Additional information

A 28-day repeated dose oral toxicity study of beta-alanine was conducted using male and female Crj:CD(SD)IGS rats according to OECD TG 407 under GLP conditions. 40, 200, and 1000 mg/kg (6 rats/sex/group) of beta-alanine, dissolved in water for injection, were administered by gavage 7 days a week for 28 days, followed by 14-day recovery period. During the dosing and recovery periods, no deaths occurred, and no treatment-related changes were observed in clinical signs, neurotoxicological observation, functional tests, body weights, food consumption, ophthalmoscopy, urinalysis, hematology, blood biochemistry, and organ weights. At the end of the recovery period, a yellow-white mass (20 × 20 × 10 mm) was found in the subcutis of the left inguinal region in one female of the 1000 mg/kg bw group. Histopathologically, this mass was recognized as adenocarcinoma in the mammary gland, and was considered spontaneous. In summary, no effects of beta-alanine on male and female SD rats receiving the maximum dose of 1000 mg/kg were observed. The NOEL and NOAEL of this study are considered to be 1000 mg/kg bw/day in both male and female rats.

 

Justification for classification or non-classification

On the basis of the study results, beta-alanine is not to be classified according to DSD and CLP classification criteria.