Registration Dossier
Registration Dossier
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EC number: 232-102-8 | CAS number: 7786-67-6
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: LD50 = 936 mg/kg bw (Lynch 1971)
Acute dermal toxicity: LD50 = approx. 5 ml/kg bw (Lynch 1971)
Key value for chemical safety assessment
Additional information
Avaliable toxicity data for isopulegol have been derived with or have been filed under the identity of a respective enantiomer, i.e. (1R,2S,5R)-5-methyl-2-(1-methylethenyl)-cyclohexanol (CAS 89 -79 -2). This enantiomer represents one main component of the registered substance DL-isopulegol and the respective data allow to cover the given toxicological endpoint.
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 (RIFM 1971). 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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