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Administrative data

Description of key information

One 28 -days repeated dose toxicity study for the oral route is available. A NOAEL of 25 mg/kg bw/day is identified. No studies for other routes are available.

Based on the findings in the short-term study a sub-chronic study for the oral route in rats is proposed.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
25 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
One 28 day repeated dose toxicity study available.

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 selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one valid study for repeated dose toxicity is available.

Justification for classification or non-classification

The presented data for repeated dose toxicity is reliable and an adequate guideline study. The observations within the study are conclusive but not sufficient for a classification as Specific Target Organ Toxicant according to Regulation (EC) No. 1272/2008.