Registration Dossier
Registration Dossier
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EC number: 216-074-4 | CAS number: 1490-04-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a Buehler test 0 out of 20 animals showed a positive reaction.The LLNA was negative.
In humans, a few cases of hypersensitivity reactions, including skin reactions and reactions in the oral and nasal
cavity, have been reported. Based on the wide exposure of consumers to these substances and also
on the results from clinical studies, which investigated a high number of subjects, the overall
sensitizing potential of the menthol isomers is considered to be low.
Migrated from Short description of key information:
The sensitisation potential of menthol was investigated by means of the Buehler Test for sensitisation in guinea pigs.
A concentration of 25% w/v of the test substance in ethanol:DEP (1:1) was selected for induction and challenge.
Additional the results from a second source of a LLNA were available. For skin sensitisation also a modified Draize procedure was applied.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
no data
Migrated from Short description of key information:
no data
Justification for classification or non-classification
In a Buehler test the test material is juged to be non-sensitising when topically applied to Hartley guinea pigs. The LLNA was also negative. Based on the available human data a sensitisation potental of the menthol isomers is considered to be low. Therefore a classification is not justified.
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