Registration Dossier
Registration Dossier
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EC number: - | CAS number: 8015-91-6
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:
Two human maximization tests according to the method described by Kligman (1966) are available for Cinnamon bark oil and were used in a weight of evidence approach. In both assays, 25 volunteers were exposed to Cinnamon bark oil as supplied via an occlusive patch. Test subjects were induced for 5 intermitting days in a 10 day period. After a recovery period, volunteers were exposed to the test substance for 24 hours. Challenge application was preceded by a 1 hour application of a 10% aqueous solution of sodium lauryl sulfate (SLS) under occlusion. The effects were scored after removal of the patch and 24 hours later. In one study, 21 out of 25 volunteers showed skin sensitisation directly after removal of the patch and 20 volunteers showed a positive response after 24 hours (72 hours after challenge). In the other study 18 out of 25 volunteers showed skin sensitisation directly and 24 hours after removal of the patch (48 and 72 hours after challenge). Based on the results of these studies, it can be concluded that Cinnamon bark oil is a skin sensitizer.
Migrated from Short description of key information:
Skin sensitisation: 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 relatively high and substantial incidence of skin reactions in two skin sensitising studies in human volunteers, Cinnamon bark oil should be classified as a skin sensitiser (Skin Sens. 1A; H317) in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
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