Registration Dossier
Registration Dossier
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EC number: 282-013-3 | CAS number: 84082-68-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Myristica fragrans, Myristicaceae.
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:
This guinea pig maximisation test (GPMT) was performed to determine the sensitising potential of nutmeg oil. No mortality and effect on body weight were reported. In the test group, 9 and 11 out of 20 guinea pigs (at 1st and 2nd reading, respectively) showed a positive skin reaction after challenge exposure to nutmeg oil. No positive skin reactions were noted in the negative control group. The results in the positive control group confirmed validity of the test (system), with 5 out of 6 animals showing positive skin reactions at the 1st and 2nd reading after challenge exposure (to 0.1% DNCB).
Under the conditions of this study, a postive skin response was observed in guinea pigs exposed to a challenge concentration of 2.0%. The sensitisation rate was calculated to be at least 45%, which exceeds the threshold value of 30% for classification. Therefore, the substance needs to be classified as sensitising based on EU-criteria.
Migrated from Short description of key information:
Guinea pig maximisation test (GPMT): sensitising (equivalent or similar to OECD406)
Justification for classification or non-classification
Based on the available data Nutmeg oil needs to be classified as sensitising based on the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
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