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EC number: 246-608-1 | CAS number: 25088-57-7
During the test the temperature was between 19 to 24 °C instead of 20 to 24 °C for several hours; this is only a study plan deviation and within the guideline recommendations of 22 ± 3 °C.
Table 2. Calculation of Stimulation Indices per Dose Group
Test item concentration %
number of lymph nodes
DPM perb)lymph node
1 = Control Group
2-4 = Test Group
a) = The mean value was taken from the figures BGI and BGII
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
OECD 429 (2018): Three groups each of four female mice were treated once daily with the test item at concentrations of 2.5, 5, and 10% in acetone/olive oil (4+1 v/v) by topical application to the dorsum of each ear for three consecutive days. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation, as confirmed by two pre-experiments. A control group of four 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 β- scintillation counter.
No mortality was reported and no signs of systemic toxicity were observed. Some animal some animals showed an erythema of the ear skin with statistically significant and biologically relevant increase in ear thickness.
Stimulation Indices of 2.29, 1.18, 2.73 were determined with the test item at concentrations of 2.5, 5, and 10% in acetone/olive oil (4+1 v/v). The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
The animals treated with the positive control item alpha-Hexylcinnamaldehyde (25% (w/v)) showed a distinctly positive response (mean S.I. of 10.33), corroborating the validity of the assay.
Based on the condition of the study, the test item did not meet the criteria for skin sensitisation in accordance with the Globally Harmonized Classification System and to CLP Regulation (EC) No. 1272/2008.
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