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EC number: 233-311-7 | CAS number: 10114-47-3
Table 1: Individual Activities, Stimulation Index and Ear weights
Individual Activity (DPM)
Ear weight (median) (mg)
The test substance, Direct Yellow 28, 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 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 sensitisation: Local Lymph Node Assay, Adopted 22th July 2010
In this study the contact allergenic potential of Direct Yellow 28 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: 50 %, 5 %, 0.5 % (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 animals exposed to the test substance at all doses showed no pathological and no other negative clinical symptoms of intoxication throughout the experiment.
Residues of the test substance on the ears were visible during whole study so it could cause slight weight increase detected only at the highest dose level. So, no irritation effect was observed which could impair the result of LLNA assay.
Stimulation Index at the all dose levels was < 3 so the result of LLNA assay is negative (see criteria in chapter 3.8. of this report).
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.
Under the given test conditions, the animals exposed to the test substance, Direct Yellow 28, do not elicit sensitising response in LLNA assay. Negative results in cell proliferation revealed that the test substance Direct Yellow 28 could not be a contact allergen in mice.
The test substance Direct Yellow 28, provides negative sensitising response in LLNA assay.
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