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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
20 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

The primary findings in the available repeated dose study are an increase in hyaline droplets in the kidneys of all treated male but not female animals. Hyaline droplet accumulation in male rats is species and sex specific and is not predictive of an effect on other species.

Hepatocellular hypertrophy and an associated increase in liver weight were observed in females dosed at 100 and 300 mg/kg/day and in males dosed at 300 mg/kg/day.

Minimal to mild thyroid follicular hypertrophy was observed in males dosed at 300 mg/kg/day which was considered to be treatment related.


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

Justification for classification or non-classification

No classification for repeated dose toxicity is indicated according to the general classification and labeling requirements