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EC number: 954-921-6
CAS number: -
Table 1: Skin sensitisation potential of
the test substance
Mean dpm/Animal(Standard Deviation)
Vehicleacetone/olive oil 4:1
Test substance10% w/w inacetone/olive oil 4:1
Test substance25% w/w inacetone/olive oil 4:1
Test substance50% w/w inacetone/olive oil 4:1
Positive Control substance25% v/v inacetone/olive oil 4:1
# Mean dpm/Animal obtained by dividing
the dpm/Animal value by 8 (due to the death of one animal on Day 4).
** Significantly different from
control group p < 0.01
*** Significantly different from
control group p < 0.001
An OECD 429 study in compliance with GLP was
performed to assess the skin sensitization potential of the test
substance in the CBA/Ca strain mouse following topical application to
the dorsal surface of the ear. Following a preliminary screening test
in which no clinical signs of toxicity were noted at a concentration of
50 % w/w, this concentration was selected as the highest dose
investigated in the main test of the Local Lymph Node Assay (LLNA).
Three groups, each of five animals, were treated with 50 µL (25 µL per
ear) of the test substance as a solution/emulsion in acetone/olive oil
4:1 at concentrations of 50 %, 25 % or 10 % w/w. A further group of five
animals was treated with acetone/olive oil 4:1 alone. A concurrent
positive control test, using a group of five animals, was also performed
with the known sensitizer, α Hexylcinnamaldehyde tech., 85 %, at a
concentration of 25 % v/v in acetone/olive oil 4:1.
Two animals treated with the test substance
in the main test were found dead on Day 4 (one animal treated with 25 %
w/w the test substance and one animal treated with 50 % w/w the test
substance). No other clinical signs were observed for the test item
treated animals during the study, and there were no treatment related
effects were observed on body weight. The Stimulation Index was
expressed as the mean radioactive incorporation for each treatment group
divided by the mean radioactive incorporation of the vehicle control
group. The concentration of the test substance expected to cause a 3
fold increase in 3HTdR incorporation (EC3 value) was calculated to be
In conclusion, under the conditions of the
present assay, the test substance, tested in a suitable vehicle (4:1
Acetone/Olive oil) was shown to have skin sensitization potential in the
Local Lymph Node Assay.
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