Registration Dossier

Administrative data

Description of key information

Based on the outcome of a Klimisch-1-rated 28 days oral repeated dose toxicity study (NOAEL = 200 mg/kg/d, LOAEL = 900 mg/kg/d) , the substance needs not to be classified as to its repeated dose toxicity properties.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
200 mg/kg bw/day

Additional information

At the treatment levels used, a No Observed Effect Level of 50 mg/kg/day was established. Furthermore the dose levels 200 mg/kg/d and 900 mg/kg/d are to be considered as NOAEL and LOAEL, respectively.

Justification for classification or non-classification

Based on the study outcome, the substance is not to be classified as to its repeated dose toxicity properties.