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Description of key information

The acute oral toxicity of the substance was assessed using:
-2 acute oral toxicity limit tests performed in rats according to OECD 401 guideline and Good Laboratory Practices (Kynoch, 1984 and Hoechst, 1988a)
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

Two reliable without restrictions studies were reported for the acute oral toxicity endpoint. The Hofman study (1988) was identified as the key study and supported by the results of the study performed by Kynoch (1984).

The Hoechst study (1988a) 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 rats.

Based on a preliminary study indicating no deaths in 1 male and 1 female rats at 2000 mg/kg bw, the main 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, no clinical signs and no effects on body weight gain were observed. There were no apparent abnormalities at necropsy.

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

The Kynoch study (1984) was designed to evaluate the toxicity of the substance following a single oral administration in rats according to the OECD guideline 401 and in compliance with the principles of Good Laboratory Practice regulations.

The sustance was prepared in 1% methylcellulose suspension and was administered by gavage under a dosage-volume of 10 ml/kg bw to 2 groups of 5 male and 5 female rats.

Based on a preliminary study indicating no deaths in 2 males and 2 female rats at 5000 mg/kg bw, the main experiment was performed at the limit dose level of 5000 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 5000 mg/kg, no mortality and no effects on body weight gain were observed. Piloerection and hunched posture were observed in all animals from day 1. Pallor of the extremities and abnormal gait were also recorded in 3 out of 5 males and 3 out of 5 females. Recovery was complete by day 4. At necropsy, there were no apparent abnormalities.

Under these conditions, the oral LD50 was higher than 5000 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 directive 67/548/EEC, the substance is not classified for acute toxicity.