Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

NOAEL = 1000 mg/kg bw/day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity (oral)

A 28-days repeated dose toxicity study was performed via oral route on rats according to the EU Method B.7 (92/69/EEC)and in compliance with GLP. 0, 150, 400 and 1000 mg/Kg bw/day of the test substance were administerd via gavage to 5 females and 5 males per dose. No mortality occured and no signs of toxicity were observed. There were no blood chemical changes that could be considered toxicologically significant and no treatment-related gross microscopic findings were observed. Therefore, the NOAEL was found to be equal to 1000 mg/kg bw/day.

Justification for classification or non-classification

Considering the avalaiable results from the 28 -days repeated dose toxicity study and the NOAEL determined, the substance is not classified for Specific Target Organ Toxicity - Repeated Exposure (STOT-RE) according to the CLP Regulation EC No. 1272/2008