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EC number: 940-042-5
CAS number: 1254940-85-6
Preliminary screening test
No signs of systemic toxicity were noted.
Based on this information the undiluted test material and the test
material at concentrations of 50% and25% v/v in acetone/olive oil 4:1
were selected for the main test.
Estimation of the proliferative response of lymph node cells.
Stimulation Index expressed as the mean radioactive incorporation for
each treatment group divided by the mean radioactive incorporation of
the vehicle control group are as follows:
Concentration (%v/v) inacetone/olive oil 4:1
observations and mortality data
There were no deaths. No signs of systemic toxicity
were noted in the test or control animals during the test.
changes of the test animals between Day 1 and Day 6 were comparable to
those observed in the corresponding control group animals over the same
of EC3 value
= c + [[(3 - d)/(b - d)] x (a - c)]a
EC3= 50 + [[(3-2.92)/(4.68-2.92)]
x (100-50)] = 52
b = actual stimulation index caused by ‘a’
c = highest concentration failing to produce a
stimulation index of 3
0 = No
signs of systemic toxicity
Individual disintegrations per minute and stimulation indices
Concentration(% v/v) inacetone/olive oil 4:1
Mean dpm/Animal(Standard Deviation)
Disintegrations per minute
a = Total
number of lymph nodes per animal is 2
b = Stimulation
Index of 3.0 or greater indicates a positive result
different from control group p<0.05
Individual clinical observations and mortality data
signs of systemic toxicity
different from control group p<0.001
Bodyweights and Bodyweight Changes
Bodyweight Change (g)
Summary of positive control data for the local lymph node assay
α‑Hexylcinnamaldehyde, tech., 85%
acetone/olive oil 4:1
ethanol/distilled water 7:3
1% pluronic L92in distilled water
of test to control lymphocyte proliferation
index greater than 3.0 indicates a positive result
Method of Preparation
Description of Formulation
acetone/olive oil (4:1)
50%0.5 ml test material + 0.5 ml vehicle
suitable for dosing
* = Suitable for dosing if
formulation is a solution or fine homogenous suspension which
can be administered via a micropipette
The sensitisation potential of the test substance, TM 10-202, was
assessed as positive according to OECD Test Guideline 429 using the
Local Lymph Node method.
For classification of a substance as a skin sensitiser, evidence from
appropriate animal studies is considered. In the case of the local lymph
node assay, the proliferation response of lymph node cells is expressed
as the number of radioactive disintegrations per minute per animal and
as the ratio of3HRdR incorporation into lymph node cells of
test nodes relative to that recorded for the control nodes (Stimulation
index). A substance is regarded as a sensitiser if at least one
concentration of the test item results in a three-fold or greater
increase in3HTdR incorporation compared to control values. A
test substance that fails to produce a three-fold or greater increase in3HTdR
incorporation is classified as a non-sensitiser. Chemicals for which the
lowest concentration tested resulted in a stimulation index of greater
than three, an EC3 value can be extrapolated from the two lowest doses.
One of the three concentrations tested for the test substance TM 10-202
gave a stimulation index of greater than 3 and therefore TM 10-202 is
considered to be a sensitiser. The concentration of
test material expected to cause a 3 fold increase in 3HTdR incorporation
(EC3 value) was calculated to be 52%.
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