Registration Dossier
Registration Dossier
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EC number: 950-969-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
No data on skin sensitization are available for the registered substance Santalene oil. The individual skin sensitization potential of each component present in Santalene oil was estimated in silico by the QSAR tool CaseUltra (version 1.7.0.5).
Three different models allow to discriminate between different potencies: 1) weak sensitizer (version 1.6.0.3.587.650); 2) moderate sensitizer (version 1.6.0.3.587.450); 3) extreme sensitizer (version 1.6.0.3.587.400). All calculations were found to be in the applicability domain of the respective model and were taken into account for the overall decision on the classification of Santalene oil. In summary, approx. 97% of all components present in the mixture have been assessed by this approach. Since a weak to moderate potential for skin sensitization was predicted for all structures, an overall classification as a skin sensitizer is indicated. The approach taken does not allow for a subcategorization into either 1A or B.
Substance
CaseUltra Model
Weak sensitizer
CaseUltra Model
Moderate sensitizer
CaseUltra Model
Extreme sensitizer
18252-46-5
positive
inconclusive
negative
512-61-8
positive
inconclusive
negative
13474-59-4
positive
inconclusive
negative
25532-78-9
positive
inconclusive
negative
18794-84-8
positive
inconclusive
negative
511-59-1
positive
inconclusive
negative
55123-21-2
positive
inconclusive
negative
495-61-4
positive
positive
negative
53585-13-0
positive
positive
negative
Furthermore, Santalene oil contains beta-Bisabolene (CAS 495-61-4) at concentrations between 1-4%. Bisabolene (isomers not specified; CAS 495-62-5) – tested in ethanol/water as a vehicle - was found to be a skin sensitizer in a LLNA, leading to an EC3 value of 8.6% (OECD 429; Givaudan, 2002; cited in the RIFM/FEMA database ID 41935). Accordingly, the constituent beta-Bisabolene (present in Santalene oil with concentrations >= 1%) shows skin sensitizing properties, which leads to a classification as skin sensitizer Cat. 1B.
Justification for classification or non-classification
Santalene oil contains components,which are predicted to be skin sensitizers. Furthermore, Santalene oil contains a component (classified as skin sensitizer Cat1B) at a concentration >=1%. Accordingly, Santalene oil fulfills the criteria laid down in regulation (EU) 1272/2008, and therefore, a classification with "Skin sensitisation" (Category 1) is warranted.
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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