Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

A screening study was performed to screen for potential adverse effects on reproduction (including offspring development) of the test material and to provide an initial hazard assessment for effect on reproduction. The study complies with the recommendations of the OECD Guidelines for Testing of Chemicals No, 421 “Reproduction/Developmental Toxicity Screening Test". The oral administration of beta-alanine to rats for a period of up to forty five days at dose levels of up to 1000 mg/kg bw/day did not show any treatment-related effects at any dose level. The No Observed Effect Level (NOEL) for reproduction and systemic toxicity was therefore considered to be 1000 mg/kg bw/day.

 


Short description of key information:
-NOAEL=1000 mg/kg bw/day (GLP, OECD TG 421 Reproduction/Developmental Toxicity Screening Test)

Effects on developmental toxicity

Description of key information
-NOAEL=1000 mg/kg bw/day (GLP, OECD TG 421 Reproduction/Developmental Toxicity Screening Test)
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

A screening study was performed to screen for potential adverse effects on reproduction (including offspring development) of the test material and to provide an initial hazard assessment for effect on reproduction. The study complies with the recommendations of the OECD Guidelines for Testing of Chemicals No, 421 “Reproduction/Developmental Toxicity Screening Test. The oral administration of beta-alanine to rats for a period of up to forty five days at dose levels of up to 1000 mg/kg/day did not show any treatment-related effects at any dose level. The No Observed Effect Level (NOEL) for reproduction and systemic toxicity was therefore considered to be 1000 mg/kg/day.

 

Justification for classification or non-classification

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