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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on the available repeated dose study NOAEL is set at 500 mg/kg bw/day for findings representing local toxicity consisted of inflammatory/hyperplastic lesions in the large intestines at 1000 and 2000 mg/kg along with presumed secondary white blood cell changes.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

Additional information

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: colon

Justification for classification or non-classification

Based on the available repeated dose study NOAEL is set at 500 mg/kg bw/day for increased kidney weights observed in male animals at the low dose. Based on these effects and the NOAEL classification and labelling is not warranted.