Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
427 mg/kg bw/day
Study duration:
subchronic
Species:
rat

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.