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EC number: 268-516-0 | CAS number: 68110-27-0
The test substance, Reactive Yellow 85, provides ambiguous sensitising response in LLNA assay.
SI at the all dose levels was < 3, but the value of DPM was significantly increased against negative control group at the middle dose level and exposure time was short at the highest dose level (the mice wiped the test substance from ears into shaving after application), so the result of LLNA assay is ambiguous (see criteria in Details on study design).
The test substance, Reactive Yellow 85, was tested for the assessment of skin sensitisation potential with the murine local lymph node assay. This study is a part of the test substance health hazard evaluation.
The Local Lymph Node Assay (LLNA) with the incorporation of 3H-methyl thymidine radionuclide was used. The testing was conducted according to the Method B.42 – Skin Sensitisation: Local Lymph Node Assay, Council Regulation (EC) No.640/2012, published in O.J. L 193, 2012 with respect to: OECD Test Guideline No. 429, Skin sensitization: Local Lymph Node Assay, Adopted 22th July 2010.
In this study the contact allergenic potential of Reactive Yellow 85 was evaluated after topical application to female BALB/c mice. Mice were exposed to three concentrations of test substance suspended in vehicle DAE 433 (mixture of 40% dimethylacetamide, 30% acetone and 30% ethanol) for 3 consecutive days.
In pilot experiment the following concentrations of test substance in application forms were used: 75 %, 7.5 %, 0.75 % (w/v). According to the results of pilot experiment the same doses were confirmed for main study.
Primary proliferation of lymphocytes in the lymph node draining the site of application was evaluated using radioactive labelling of proliferating cells. The ratio of the proliferation in treated groups to that in vehicular controls, termed the Stimulation Index, was determined. The evaluation of ear weight was performed for elimination of false positive findings with certain skin irritants.
The positive control item Dinitrochlorobenzene (DNCB) as a contact allergen (concentration 0.5% (w/v) elicited the expected reaction pattern with significant increase in Stimulation Index of cell proliferation and of ear weight. Appropriate performance of the assay in the test laboratory was then demonstrated.
The animals exposed to the test substance at all doses showed no pathological and no other negative clinical symptoms of intoxication throughout the experiment.
Statistically significant increase of ear weight was recorded at the highest dose level.
Under the given test conditions, the animals exposed to the tested concentrations of the test substance Reactive Yellow 85 in LLNA assay, elicited ambiguous results in cell proliferation revealed that the test substance Reactive Yellow 85 could be a contact allergen in mice, but it should be proved by further testing.
The test substance Reactive Yellow 85, provides ambiguous sensitising response in LLNA assay.
The results from positive and negative controls demonstrate that the method performed had sufficient reliability .
The animals exposed to the tested concentrations of the test substance Reactive Yellow 85 (75%, 7.5% and 0.75% w/v) showed no skin reactions and clinical symptoms of intoxication throughout the experiment.
The values of SI for the test groups treated by the test substance Reactive Yellow 85 at the all dose levels were below the threshold, stimulation index (SI) was < 3. The value of DPM at the highest dose level was probably affected by the shorter time of exposure, because the mice wiped the test substance from ears into shaving after application.
The value of DPM of the middle dose level was significantly increased against negative control group at, so the result of LLNA assay is ambiguous.
Under the given test conditions, the animals exposed to the tested concentrations of the test substance Reactive Yellow 85 in LLNA assay, elicited ambiguous results in cell proliferation revealed that the test substance Reactive Yellow 85 could be a contact allergen in mice.
The test substance, Reactive Yellow 85, provides ambiguous sensitising response in LLNA assay and it is concluded to classify the substance as skin sensitiser category 1B.
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