Registration Dossier

Administrative data

Description of key information

Two reliable repeated dose toxicity studies were conducted in rats in which the substance was administered for 28 and 90 days respectively both via oral gavage. Minimal effects were observed in those studies, however these effects were not considered to be adverse and the NOAEL for both studies is 1000 mg/kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Sufficient to address requirements.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the findings of reliable sub-acute and sub-chronic toxicity studies conducted on the substance, classification is not justified.