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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1 000 mg/kg bw/day

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.