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EC number: -
CAS number: -
The aim of this study was to determine the skin sensitisation
potential of Golden Yellow Continuous following dermal exposure.
Based on results of the Preliminary Compatibility Test and on
recommendations of the OECD Test Guideline 429, the test item was
dissolved in Dimethyl-sulphoxide (DMSO). The maximum attainable
concentration based on solubility of the test item in DMSO was 10%.
A Preliminary Irritation/Toxicity Test was performed with the test
item at concentrations of 10% and 5% in the selected vehicle. According
to this test, the applicability and biocompatibility of the test item to
the animals’ ears (2 female CBA/J@Rj mice/dose) at the maximum
concentration of 10% was acceptable.
In the main assay twenty female CBA/J@Rj mice were allocated to
five groups of four animals each:
groups received the appropriate formulation of Golden Yellow Continuous
at concentrations of 10%, 5% and 2.5%,
negative control group received the vehicle (DMSO),
positive control group received 25% alpha-Hexylcinnamaldehyde (HCA) in
The test item solutions were applied to the dorsal surface of both
ears of the mice (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 systemic clinical signs were observed during the
study. No treatment related effects were observed on animal body weights
in any of the treated groups. No cutaneous reactions were observed at
the site of the treatment in any of the treated groups.
No significant lymphoproliferative response (SI ³ 3) of Golden
Yellow Continuous was observed at the concentrations applied compared to
the negative control. The stimulation index values of the test item were
1.6, 1.7, and 2.6 at treatment concentrations of 10%, 5%, and 2.5%,
respectively. No conventional dose-response to treatment was observed.
A significant lymphoproliferative response (stimulation index
value of 6.6) was noted for the positive control chemical HCA. This
result confirmed the validity of the assay.
In conclusion, under the conditions of the present assay Golden
Yellow Continuous, tested in a suitable vehicle, proved to have no
sensitization potential (non-sensitizer) in the Local Lymph Node Assay.
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