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Administrative data

Description of key information

The acute oral toxicity of the substance was assessed using:
- An acute oral toxicity limit test performed in rats according to OECD 401 guideline and Good Laboratory Practices (Hoechst, 1990).
The substance is of low acute toxicity following oral exposure:
The oral LD0 was found to be greater than 2000 mg/kg bw in both sexes.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The acute oral toxicity study was reliable with some restrictions due to limited information mentioned in the report.

The Hoechst study (1990) was performed in rats according to the OECD guideline 401 and to the EU Method B.1. The study was conducted in compliance with the principles of Good Laboratory Practice regulations.

The substance was prepared in sesame oil and was administered by gavage under a dosage-volume of 10 ml/kg bw to 2 groups of 5 male and 5 female rat. The experiment was performed at the limit dose level of 2000 mg/kg bw.

Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy.

At the dose-level of 2000 mg/kg, no mortality and no effects on body weight gain were observed. The animals showed impaired breathing and motion, as well as blood-colored, crusty snouts. The symptoms were reversible by day 4. There were no apparent abnormalities at necropsy.

The oral LD50 was found to be higher than 2000 mg/kg bw in rats.

Justification for classification or non-classification

According to the criteria laid down in EU regulation (EC) n° 1272/2008/EC (CLP) and EU directive67/548/EEC, the substance is not classified for acute toxicity.