Registration Dossier
Registration Dossier
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EC number: 282-015-4 | CAS number: 84082-70-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Mentha piperita, Labiatae.
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Several studies on the skin sensitising potential of Cornmint oil were available for the dossier, which are read across to peppermint oil. Because of the comparable reliability between the studies and the differing outcomes, a Weight of Evidence approach was used to describe the endpoint of skin sensitisation.
Four guinea pig maximisation tests were available with different forms of cornmint oil, one using Peppermint Arvensis (65% Peppermint Brazilian and 35% Peppermint Chinese), one using Peppermint Chinese, and two using Peppermint Brazilian. In all tests three challenges with the test substance were performed. The first two challenges with Peppermint Arvensis indicated no skin sensitisation, only after three challenges sensitisation was indicated. The first challenge with Peppermint Chinese indicated skins sensitisation. However, the second and third challenge did not indicate skin sensitisation. In both studies conducted with Peppermint Brazilian, the first and third challenge indicated skin sensitisation.
Additionally tot the guinea pig maximisation tests, a human repeated occluded patch test was available which indicated allergic contact sensitisation in 2 out of 22 male subjects.
Based on the above information, it was concluded that peppermint oil is a substance that possesses the ability to induce skin sensitisation. Three of the four animal studies indicated sensitisation and the human study indicated skin sensitisation in two subjects.
Migrated from Short description of key information:
Skin sensitisation (Weight of Evidence, read across from cornmint oil):
- GPMT (5% Peppermint Arvensis): not sensitising (method similar to OECD 406)
- GPMT (5% Peppermint Chinese): sensitising (method similar to OECD 406)
- GPMT (5% Peppermint Brazilian): sensitising (method similar to OECD 406)
- GPMT (5% Peppermint Brazilian): sensitising (method similar to OECD 406)
- Maximization test (humans): sensitising
Justification for selection of skin sensitisation endpoint:
No selection is made as a Weight of Evidence approach was followed which is described below.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, peppermint oil needs to be classified for skin sensitisation when taking into account the criteria outlined in Annex VI of 1272/2008/EC and Annex I of 67/548/EEC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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