Registration Dossier

Diss Factsheets

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.