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EC number: 232-087-8
CAS number: 7785-70-8
Neither mortality nor clinical signs were
observed during the study. The body weight gain of the treated animals
was similar to that of the control animals.
Treatment and concentrations
Amount of cells (x106cells)
Number of nodes per group
dpm per group
dpm per node
Stimulation index (SI)
Increase in ear thickness (% between day1 and day 6)
Test item 5%
Test item 10%
Test item 25%
Test item 50%
Test item 100%
(viable cells/(viable cells+dead cells))*100
index=amount of cells (x106cells) in the treated groups/
amount of cells (x106cells) in the vehicle groups
index=dpm of treated group/dpm of control group
disintegration per minute
non-irritant (increase in ear thickness < 10%)
irritant (increase in ear thickness = 10 to 30%)
Theoretical concentration resulting in a SI value of 3
a dermal sensitization study performed according to theOECD
guideline 429 and in compliance with the GLP, (-)-beta
pinene in Acetone/Olive oil (4/1,
v/v) was administered to CBA/J mice. In the preliminary assay, at the
highest tested concentration (100%) only, dryness of the skin was
observed in one animal. The highest increase in ear thickness (15.38%),
observed in one animal treated at the concentration of 100%, was
attributed to a slight irritation. Since the test item was not
excessively irritant in the preliminary test, the highest concentration
retained for the main test was the maximal practicable concentration
treated groups of four animals receiving applications of 0.25 µL of the
test item to the external surface of botch ears at the concentration of
5, 10, 25, 50 or 100% in the vehicle. The Lymph node proliferative
responses were measured as described by Kimber and Dearman (1991).
positive control (α-hexylcinnamaldehyde)
acceptable positive results (stimulation
index of 14.17).
clinical signs and no mortality were observed during the study. A
dryness of the skin was noted in all animal treated at the concentration
of 100%, associated with an erythema in one of them. The increase in ear
thickness measured in the 100% group was 21.36%, corresponding to a
slightly irritant potential of the test item when used in its original
form. A significant lymphoproliferation was noted at tested
concentrations of 50% and 100%: the stimulation index was higher than 3
at these two concentrations. In the absence of excessive local
irritation, the significant lymphoproliferative responses observed were
attributed to delayed contact hypersensitivity. The EC3 value was 29%.
the experimental conditions of this study, (-)-beta pinene induced
delayed contact hypersensitivity in the murine Local Lymph Node Assay.
Therefore, (-)-beta pinene is classified as skin sensitizer category 1B,
H317 according to CLP Regulation (EC) No. 1272/2008 and as skin
sensitizer "Xi, R43: May cause sensitisation by skin contact" according
to the Directive 67/548/EEC.
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