Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
30 mg/kg bw/day
Study duration:
subchronic
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

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

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; urogenital: kidneys

Justification for classification or non-classification

One key study is available for this endpoint.

In a subchronic toxicity study performed according to OECD testing guideline 407, the test item was administered to Wistar rats by gavage for 90 days at dose levels of 0, 10, 30 and 100 mg/kg bw/day. The NOAEL of this study is established at 30 mg/kg bw/day for both male and female Wistar rats, on the basis of the effects observed in liver and kidneys at 100 mg/kg bw/day.

Considering that the effects observed at 100 mg/kg bw/day are slight, with no macroscopic findings in the organs concerned and that the test conditions do not allow to detect a dose-relationship (no effect at 10 and 30 mg/kg bw/day), it is concluded that the results are not sufficient in order to classified the substance as a specific target organ toxicant following repeated exposure (STOT RE) according to CLP criteria.