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Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
427 mg/kg bw/day
Study duration:

Additional information

No data is available by dermal or inhalation route.

A 28 days study was also performed and the NOAEL is lower than in the 90-d study (30 mg/kg/day and 427 mg/kg/day, respectively). Differences in the study design can maybe explain this observation: the subacute study was performed by gavage in Sprague-Dawley rats and the subchronic study was carried out with a dietary exposure and using Wistar rats. However, the slight hepatotoxicity is a common effect observed in both cases.

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; other: all gross lesions and masses

Justification for classification or non-classification

No classification regarding repeated toxicity has been defined for this substance in the annex VI. This is not necessary based on the available data.