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EC number: 940-783-4
CAS number: -
The aim of this study was to determine the
skin sensitisation potential following dermal exposure. The study was
performed with vertebrate animals as no regulatory in vitro alternative
is available. The minimum number of animals was used, corresponding to
the regulatory guidelines being followed.
Based on the results of the Preliminary
Compatibility Test and on the recommendations of the OECD Guideline ,
the test item was tested for formulation compatibility in Acetone :
Olive oil 4:1 (v/v) mixture (abbreviated as AOO). The highest achievable
concentration was 100% (undiluted).
The Preliminary Irritation / Toxicity Test
was performed in CBA/J Rj mice using two doses (100% (undiluted) and 50%
(w/v)) in the selected vehicle. Based on the observations recorded in
the preliminary test, the 50% (w/v) concentration was selected as top
dose for the main test.
In the main assay, twenty-four female CBA/J
Rj mice were allocated to six groups of four animals each:
- four groups received the test substance
(formulated in AOO) at 50, 25, 10 and 5% (w/v) concentrations,
- the negative control group received the
- the positive control group received 25%
(w/v) HCA (dissolved in AOO).
The test item solutions were applied on the
dorsal surface of ears of experimental animals (25 μL/ear) for three
consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5
and 6. On Day 6, the cell proliferation in the local lymph nodes was
measured by incorporation of tritiated methyl thymidine (3HTdR) and the
values obtained were used to calculate stimulation indices (SI).
No mortality or signs of systemic toxicity
were observed during the main study. No treatment related effects were
observed on body weight. The appearance of the lymph nodes was normal in
the negative (vehicle) control group and in the 25, 10 and 5% (w/v) test
item treated groups. Larger than normal lymph nodes was observed in the
positive control group and in the 50% (w/v) test item treated group.
The observed stimulation index values were
2.3, 1.3, 0.7 and 0.6 at concentrations of 50, 25, 10 and 5% (w/v),
The result of the positive control substance
α-Hexylcinnamaldehyde (HCA) dissolved in the same vehicle was used to
demonstrate the appropriate performance of the assay. A significant
lymphoproliferative response (stimulation index value of 7.1) was noted
for the positive control chemical, this result confirmed the validity of
In conclusion, under the conditions of the
present assay the test substance tested in a suitable vehicle, was shown
to have no sensitisation potential (non-sensitizer) in the Local Lymph
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