Registration Dossier

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

0.25 µL of (-)-beta-pinene in Acetone/olive oil (4/1, v/v) at concentrations of 0 (vehicle control), 5, 10, 25, 50 and 100% (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 5, 10, 25, 50 and 100 % were 2.29, 1.16, 2.23, 7.17 and 6.47, respectively. The calculated effective concentration inducing a SI of 3 (EC3) was 29 %. The threshold positive value of 3 was exceeded at the concentration of 50%. In the absence of local irritation, the significant lymphoproliferative responses observed were attributed to delayed contact hypersensitivity. Therefore, (-)-beta-pinene was considered as skin sensitising.

In maximisation tests on guinea pigs conducted with delta-3-carene and turpentine oil, 15/22 and 16/25 animals showed positive responses, respectively. In a clinical trial, turpentine oil was identified as a strong sensitiser, with 16/25 human volunteers showing positive response to turpentine oil.


Migrated from Short description of key information:
(-)-beta-Pinene induced skin sensitisation in a Local Lymph Node Assay (LLNA): EC3 = 29%. Positive results were also obtained with delta-3-carene and turpentine oil in maximisation tests, and turpentine oil was identified as a strong sensitiser in humans (section 7.10.4).

Justification for classification or non-classification

(-)-beta-Pinene induced positive response in a LLNA with an EC3 = 29% 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.