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EC number: 266-564-7
CAS number: 67075-37-0
No biological relevant changes in ear thickness occurred.
No deaths occurred during the study period. Neither clinical / local
signs nor other findings were observed in any animals of the control
group. After the first topical application, the residual test item was
found at both dosing sites in all mice of the test item groups,
persisting for the remainder of the in-life phase of the study. The body
weight of the animals, recorded prior to the first application and prior
to necropsy, was within the range commonly recorded for animals of the
strain and age.
S.I. = Stimulation Index
* Dunnett-test (G = 4, N= 20, t= 2.59)
-- no significant difference at p </= 0.05 (two sides)
No dose-response relationship was observed. Calculation of the EC3 value
was not performed because no test concentrations produced a Stimulation
Index (S.I.) of 3 or higher.
In order to study a possible contact allergenic potential of the test
article, a GLP compliant Local Lymph Node Assay according to the OECD
guideline No. 429 was performed. Three groups each of five female mice
were treated daily with the test item at concentrations of 5%, 10 % and
25 % in acetone/olive oil (4/1, v/v) by topical application to the
dorsum of each ear lobe (left and right) for three consecutive days. 25
% was the highest technically applicable concentration in the vehicle. 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 per group. 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 of 3H-methyl thymidine measured in a ß-scintillation
counter. All treated animals survived the scheduled study period.
Neither clinical / local signs nor other findings were observed in any
animals of the control group. After the first topical application, the
residual test item was found at both dosing sites in all mice of the
test item groups (Groups 2-4), persisting for the remainder of the
in-life phase of the study. In this study STIMULATION INDICES of 1 .2, 1
.2 and 0.8 were determined with the test item at concentrations of 5%,
10 % and 25 % in acetone/olive oil (4/1, v/v), respectively. Calculation
of the EC 3 value was not performed because no test concentrations
produced a STIMULATION INDEX (S .I .) of 3 or higher. Based on this
result, the test article was found to be a non-sensitizer when tested up
to the highest applicable concentration of 25 % in acetone/olive oil
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