Registration Dossier

Administrative data

Description of key information

Oral: LD50= 3362 mg/kg bw, male/female rat, equiv. to OECD 401, Industrial Bio-Test Laboratories Inc. 1977

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
3 362 mg/kg bw
Quality of whole database:
The available information as a whole meets the tonnage driven information requirements of REACH.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute Oral:

The pre-GLP study was performed following a method similar to OECD 401 to assess the acute oral toxicity potential of the test substance to male/female CD Strain, Crl: COBS CD (SD) BR rats. The test material was administered as a single oral dose, by gavage, to a group of 10 male and 10 female rats following an overnight fast. The animals were observed for 14 days and survivors were then euthanized. All animals were subject to necropsy. One animal from the 3038 mg/kg dose group died on day 2; all remaining animals below this dose survived to the end of the study. Clinical signs of toxicity were noted in most animals on the day of dosing. There was no adverse effect on bodyweight gain in animals of either sex. Necropsy examination of the animals that died revealed haemorrhaged lungs in animals. In addition, pale mottled livers, pale kidneys, a distended gastrointestinal tract, gastric haemorrhages, intestinal haemorrhages and advanced postmortem autolysis (due to overnight mortality) were observed. Examination of the survivors revealed necrotic tissue in the stomach lining in one animal. Under the conditions of this study, the LD50 of the test substance was calculated to be 3362 mg/kg.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for acute toxicity.

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity.