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EC number: 257-077-0
CAS number: 51240-95-0
and results of individual data; Vehicle: acetone/olive oil (4:1 v/v)
Test item concentration
DPM values measured
DPM-BG per animal(2 lymph nodes)a)
BG = Background
(1 ml 5% trichloroacetic acid) in duplicate
1 = Control
2-4 = Test
S.I. = Stimulation
a) = values
corrected for mean background value (BGI and BGII).b) = Stimulation
Indices relative to the mean of the control group (Group 1)
Calculation of Stimulation Indices per Dose Group
DPM perlymph nodea)
5 % 1,1,3,3-tetramethylbutyl peroxyneodecanoate
10 % 1,1,3,3-tetramethylbutyl peroxyneodecanoate
25 % 1,1,3,3-tetramethylbutyl peroxyneodecanoate
DPM/animal was determined by dividing the sum of the measured values from
lymph nodes of all animals within a group by the number of animals in
value could not be calculated, since all obtained SI´s were below the
threshold value of 3.
occurred during the study period.
of local toxicity at the ears of the animals and no systemic findings
were observed during the study period.
weight of the animals, recorded prior to the first application and prior
to treatment with 3HTdR, was within the range commonly recorded for
animals of this strain and age.
measured ear weights of all animals treated were recorded after
sacrifice. A statistically significant increase in ear weights was not
observed in any treated group in comparison to the vehicle control group.
In order to
study a possible skin sensitization potential of
1,1,3,3-tetramethylbutyl peroxyneodecanoate, three groups each of five
female mice were treated once daily with the test item at concentrations
of 5, 10, and 25% (v/v) in acetone:olive oil (4+1 v/v) by topical
application to the dorsum of each ear for three consecutive days. A
control group of five mice was treated with the vehicle (acetone:olive
oil (4+1 v/v)) only. Five days after the first topical application the
mice were injected intravenously into a tail vein with radio-labelled
thymidine (3H-methyl thymidine). Approximately five hours
after intravenous injection, the mice were sacrificed, the draining
auricular lymph nodes excised and pooled for each animal. Single cell
suspensions of lymph node cells were prepared from pooled lymph nodes,
which were subsequently washed and incubated with trichloroacetic acid
overnight. The proliferative capacity of pooled lymph node cells was
determined by the incorporation of3H-methyl thymidine
measured in ab-scintillation counter.
did not show any signs of local skin irritation or systemic toxicity
during the course of the study and cases of mortality were also not
observed. A statistically significant increase in ear weights was not
observed in any dose group in comparison to the vehicle control group.
A test item
is regarded as a sensitiser in the LLNA if the exposure to one or more
test concentration resulted in 3-fold or greater increase in
incorporation of3HTdR compared with concurrent controls, as
indicated by the Stimulation Index (S.I.). The estimated concentration
of test item required to produce a S.I. of 3 is referred to as the EC3
study Stimulation Indices (S.I.) of 0.54, 1.84, and 2.24 were determined
with the test item at concentrations of 5, 10, and 25% (v/v) in
acetone:olive oil (4+1 v/v), respectively. A dose response was observed.
Although a statistically significant increase in DPM value was observed
in the mid and the high dose group in comparison to the vehicle control
group, this was not considered as biologically relevant as the S.I.
determined for these concentrations did not exceed the threshold value
of 3 for a positive response.
EC3 value could not be calculated, since all obtained SI´s were below
the threshold value of 3.
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