Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.