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EC number: 242-060-2
CAS number: 18172-67-3
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
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.
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.
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