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EC number: 700-183-3 | CAS number: 52299-25-9
The purpose of this Local Lymph Node assay was to identify the contact allergenic potential of the test item when administered to the dorsum of both ear lobes of mice. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man.
In order to study a possible allergenic potential of the test item, three groups each of four female mice were treated with different concentrations of the test item dissolved in water (1% Lutrol F68) by topical application at the dorsum of each ear lobe (left and right) on three consecutive days. A control group of four mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed and 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 beta-scintillation counter.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (SI) of 0.61, 0.66, and 2.24 were determined with the test item at concentrations of 2.5, 5 and 10% (w/v) in water (1% Lutrol F68), respectively.
Based on the results obtained, the test item was not a skin sensitiser in this assay.
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