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Description of key information

NOEL (28 days): 1000 mg/kg/day

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

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

Additional information

In this subacute 28-day toxicity study, the test item was administered daily by gavage to SPF-bred Wistar rats. The study comprised of four groups.


FINDINGS:


At 50 mg/kg/day: No treatment-related changes detected.


At 200 mg/kg/day: No treatment-related changes detected.


At 1000 mg/kg/ day: No treatment-related changes detected.

Justification for classification or non-classification

Based on the information available for repeated dose toxicity and according to the CLP Regulation n.1272/2008, table 3.9.1 ,  the substance is not classified for specific target organ toxicity-repeated exposure.