Registration Dossier
Registration Dossier
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EC number: 201-940-6 | CAS number: 89-79-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
In the key study, i.e. a guinea pig maximization test similar to OECD TG 406, female Hartley guinea pigs were treated intradermally and topically with 10% isopulegol for induction and with 5%, 10%, 20% and 40% isopulegol in propyleneglycol/acetone (topically) for challenge (Takasago International Corp. 1994). The test item produced a 0 (0/5) sensitisation index and was classified as a non-sensitiser to guinea pig skin at a maximum concentration of 40%.
In a guinea pig open epicutaneous test reported from secondary source, 21 topical applications at concentrations ranging from 0.3 to 100% isopulegol for induction and 2 topical challenge applications using the minimum irritating concentration and three 3-fold serial dilutions were performed (Klecak 1985). According to the authors, isopulegol has been found negative in this guinea pig open epicutaneous test.
In a maximization test with 25 volunteers available as secondary source, isopulegol produced no skin sensitization reactions when applied at a concentration of 8% (5520 µg/cm2) in petrolatum (Kligman 1971).
Dermal 48 -hour application of 5% isopulegol in petrolatum to perfume-sensitive male and female patients resulted in sensitization reactions of 2/20 patients, which reacted to multiple other fragrance materials used in this study (Larsen 1977).
Taken together, isopulegol is considered to have no skin sensitizing properties.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No data available.
Justification for classification or non-classification
The present data on dermal sensitization 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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