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Description of key information

Acute oral toxicity:  LD50 = 936 mg/kg bw (RIFM 1971)
Acute dermal toxicity: LD50 = approx. 5 ml/kg bw (RIFM 1971)

Key value for chemical safety assessment

Additional information

Acute oral toxicity:

In the chosen key study, isopulegol has been administered at doses of 0.313, 0.625, 1.25, 2.5, 5 ml/kg bw (approx. 285, 570, 1140, 2275, 4550 mg/kg bw based on a density of 0.909 g/ml) to Sprague-Dawley rats via gavage (RIFM 1971). The acute oral LD50 of the test substance in rats was found to be 1.030 ml/kg (approx. 936 mg/kg bw).

Acute dermal toxicity:

In the chosen key study, isopulegol has been administered topically (occlusive) for 24 hours at doses of 1.25, 2.5, 5, 10 ml/kg bw (approx. 1140, 2275, 4550, 9090 mg/kg bw based on a density of 0.909 g/ml) to New Zealand White rabbits (RIFM1971). The skin has been abraded in 2/4 animals per dose group. The acute dermal LD50 of the test substance in rats has been set at approx. 5 ml/kg bw.

Justification for classification or non-classification

The test substance is to be classified with an R22 or acute oral toxicant (category 4) according to the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, respectively.

The present data on acute dermal toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.

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