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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The oral LD50 exceeds 8000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
8 000 mg/kg bw

Additional information

In this acute toxicity study, the test substance was administered to Tif:RAIf rats (orally, gavage) in doses of 5000, 6000, 7000 and 8000 mg/kg body weight (5 females and 5 males per dose). The rats were observed in the 14 days that followed. During the test period, no mortality was observed and the rats gained weight. Clinical signs were observed up to 8 days after exposure (e.g. slight sedation, dyspnea, exophthalmos, ruffled fur, diarrhea and slight curved bodies), but all animals at all doses were recovered by day 9. At necropsy, no substance related gross organ changes were seen. The acute oral LD50 of the test material in rats of both sexes observed over a period of 14 days is greater than 8000 mg/kg. The test material has therefore practically no acute toxicity to the rat by this route of administration.

Justification for classification or non-classification

Based on the available information the test substance does not need to be classified for acute oral toxicity in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.