Registration Dossier

Administrative data

Description of key information

Based on the available repeated dose study NOAEL is set at 500 mg/kg bw/day for findings representing local toxicity consisted of inflammatory/hyperplastic lesions in the large intestines at 1000 and 2000 mg/kg along with presumed secondary white blood cell changes.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: colon

Justification for classification or non-classification

Based on the available repeated dose study NOAEL is set at 500 mg/kg bw/day for increased kidney weights observed in male animals at the low dose. Based on these effects and the NOAEL classification and labelling is not warranted.