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EC number: 800-426-4
CAS number: 1373883-45-4
- Clinical Observations, Skin Irritation and Mortality Data
Sticky coloured residual test item on the ears was noted in all
test animals. Very slight erythema on both ears was noted on Days 2 to
4, in animals treated with the undiluted test item or the test item at a
concentration of 50% v/v in acetone/olive oil 4:1 (Table 1). Thickening
of the ears, possibly due to the residual test item, was noted in all
test animals (Table 2). A greater than 25% increase in mean ear
thickness was noted in animals treated with the undiluted test item or
the test item at a concentration of 50% v/v in acetone/olive oil 4:1,
but was considered to be due to residual test item on the ears rather
than excessive irritation. No irritation indicated by an equal to or
greater than 25% increase in mean ear thickness was noted in animals
treated with the test item at a concentration of 25% v/v in
acetone/olive oil 4:1.
There were no deaths. No signs of systemic toxicity were noted in
the test or control animals during the test.
Table 1. Local Skin Irritation – Main Test
Local skin irritation (erythema score)
Table 2. Mean Ear Thickness Changes
Ear thickness (mm)
Mean Day 1 pre-dose (n =4)
Mean Day 3 post-dose (n =4)
Mean change Day 1-3 (%)
Mean Day 6 post-dose (n =4)
Mean change Day 1-6 (%)
* Possibly due to residual test item on the ears
** > 25% increase considered to be due to residual test item on
- Body weight
Bodyweight 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 period except for one animal treated with the
undiluted test item which showed a greater than expected bodyweight gain
- Estimation of the Proliferative Response of Lymph Node Cells
The radioactive disintegrations per minute per lymph node and the
stimulation index are given in Table 3.
Table 3. Disintegrations per Minute (dpm), Disintegrations per
Minute/Node and Stimulation Index
* Disintegrations per minute/node obtained by dividing the
disintegrations per minute value by 8 (total number of lymph nodes)
na = not applicable
- Calculation of EC3 value
EC3= c + [[(3−d)/(b−d)] x (a−c)]
a = 50
b = 4.97
c = 25 or 100
d = 2.99 or 2.24
EC3= 25 + [[(3−2.99)/(4.97−2.99)] x (50−25)] = 25.1 (using SI
values for 25% and 50% for calculation)
EC3= 100 + [[(3−2.24)/(4.97−2.24)] x (50−10)] = 86.1 (using SI
values for 50% and 100% for calculation)
The concentration of test item expected to cause a 3-fold increase
in ³HTdR incorporation (EC3 value) was calculated to be 25.1 or 86.1%.
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