Registration Dossier

Diss Factsheets

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. 

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