Registration Dossier
Registration Dossier
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EC number: 209-578-0 | CAS number: 586-62-9
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:
In a LLNA performed according to OECD 429 Guideline and in compliance with GLP, groups of CBA/J mice (4 females/dose) were exposed to 25 µL
of terpinolene monoconstituent in Acetone/Olive oil (4/1, v/v) at concentrations of 0 (vehicle control), 2.5, 5, 10, 25 and 50 % (v/v) to the dorsal surface of both ears for three consecutive days.No clinical signs and no mortality were observed during the main test. No local reactions and no notable increase in ear thickness were observed at any of the tested concentrations. Stimulation Index for 2.5, 5, 10, 25, and 50 % were 1.24, 2.14, 3.43, 14.44 and 20.51, respectively. The calculated effective concentration inducing a SI of 3 (EC3) was 8 %. A dose-related increase in the SI was recorded at concentrations higher than 2.5%, and the threshold positive value of 3 was exceeded at the concentration of 10%. In the absence of local irritation, the significant lymphoproliferative responses observed were attributed to delayed contact hypersensitivity. Therefore, terpinolene monoconstituent was considered as skin sensitising.
Migrated from Short description of key information:
Terpinolene monoconstituent induced skin sensitisation in a Local Lymph Node Assay (LLNA): EC3 = 8%.
Justification for selection of skin sensitisation endpoint:
Only one study available for this endpoint
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Terpinolene monoconstituent induced positive response in a LLNA with an EC3 = 8% therefore it is classified as sensitising "R43: May cause sensitisation by skin contact" according to Directive 67/548/EEC and as skin sensitiser Category 1B according to CLP Regulation (EC) No 1272/2008.
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