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EC number: 260-913-7 | CAS number: 57712-94-4
The test material was assessed for genotoxicity in cultured mammalian cells (L5178Y TK +/ ) both in the presence and absence of metabolic activation according to OECD Test Guideline 476 and EC No. 440/2008 B.17: Mutagenicity in vitro mammalian cell gene test.
Solvent Red 19E was completely dissolved in dimethylsulfoxide (DMSO). The vehicle DMSO served as the negative control.
In the preliminary experiment without and with metabolic activation (24-hour or 3-h exposure) test item precipitation was noted in the experiments without and with metabolic activation at concentrations of 250 and 500 µg Solvent Red 19E/mL. No signs of cytotoxicity (decreased survival) were noted in the absence and presence of metabolic activation up to the top concentration of 500 µg/mL.
Hence, in the main study the concentration-range of 15.63 to 250 µg/mL was used in the experiments without and with metabolic activation.
Methylmethanesulfonate (at 10 or 15 µL/mL) was employed as a positive control in the absence of exogenous metabolic activation and 3-Methylcholanthrene (at 2.5 or 4.0 µg/mL) in the presence of exogenous metabolic activation.
In the main study test item precipitation was noted in the experiments without and with metabolic activation at the top concentration of 250 µg Solvent Red 19E/mL. No signs of cytotoxicity (decreased survival) were noted in the absence and presence of metabolic activation up to the top concentration of 250 µg/mL.
The values of mutation frequencies of the negative controls ranged from 57.58 to 100.07 per 106 clonable cells in the experiments without metabolic activation and from 49.79 to 87.75 per 106 clonable cells in the experiments with metabolic activation and, hence, were well within the historical data-range.
The mutation frequencies of the cultures treated with Solvent Red 19E ranged from 63.98 to 82.89 per 106 clonable cells (3 hours exposure) and from 63.02 to 110.56 per 106 clonable cells (24 hours exposure) in the experiments without metabolic activation and from 66.12 to 77.26 per 106 clonable cells (3 hours exposure, first assay) and from 80.24 to 93.79 per 106 clonable cells (3 hours exposure, second assay) in the experiments with metabolic activation. These results were within the range of the negative control values and the normal range of 50 to 170 mutants per 106 viable cells and, hence, no mutagenicity was observed according to the criteria for assay evaluation.
In addition, no change was observed in the ratio of small to large mutant colonies, ranging from 0.63 to 1.22 for Solvent Red 19E treated cells and from 0.59 to 1.08 for the negative controls.
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