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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Increase of urea nitrogen was observed at the end of the administration period, and increases of creatinine and chloride were observed at the end of the recovery period in females given 1000 mg/kg/day. Hyaline droplets and eosinophilic bodies in proximal tubular epithelium were observed in males given 200 mg/kg or more. However no effects were observed on reproductive performance of parents or on developmental performance in pups. The NOAELs for systemic toxicity for parents are considered to be 40 mg/kg/day for males, 200 mg/kg/day for females, but for reproductive and developmental toxicity are considered to be 1000 mg/kg/day for parents and pups.


Short description of key information:
The NOAELs for reproductive and developmental toxicity are considered to be 1000 mg/kg/day for parents and pups (OECD 422).

Effects on developmental toxicity

Description of key information
The NOAELs for reproductive and developmental toxicity are considered to be 1000 mg/kg/day for parents and pups (OECD 422).
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Increase of urea nitrogen was observed at the end of the administration period, and increases of creatinine and chloride were observed at the end of the recovery period in females given 1000 mg/kg/day. Hyaline droplets and eosinophilic bodies in proximal tubular epithelium were observed in males given 200 mg/kg or more. However no effects were observed on reproductive performance of parents or on developmental performance in pups. The NOAELs for systemic toxicity for parents are considered to be 40 mg/kg/day for males, 200 mg/kg/day for females, but for reproductive and developmental toxicity are considered to be 1000 mg/kg/day for parents and pups.

Justification for classification or non-classification

The NOAELs for reproductive and developmental toxicity are considered to be 1000 mg/kg/day for parents and pups, therefore according to Regulation (EC)1272/2008 the substance is not considered to be classified.

Additional information