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EC number: 242-362-4
CAS number: 18479-58-8
Table 1: Preliminary Toxicity Test Results
% RSG (-S9)
%RSG (+ S9)
Table 2: Experimental Results
4-Hour Test Without S9
4-Hour Test With S9
* Not plated for viability or 5-TFT resistence.
** Treatment excluded from statistics due to toxicity.
Table 3: Experimental Results
24-Hour Test Without S9
p < 0.05
The GLP compliant study was conducted according to a method that was designed to assess the potential mutagenicity of the test material on the thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line. The method used meets the requirements of the OECD (476), Method B17 of Commission Regulation (EC) No. 440/2008 of 30 May 2008. One main experiment was performed. In this main experiment, L5178Y TK +/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test material at eight dose levels, in duplicate, together with vehicle (DMSO) and positive controls. The exposure groups used were as follows: 4-hour exposures both with and without metabolic activation, and 24 hours without metabolic activation. The dose range of test material was selected following the results of a preliminary toxicity test and was 12.5 to 200 |jg/ml for the 4-hour exposure group in the absence of metabolic activation, 25 to 250 |jg/ml for the 4-hour exposure group in the presence of metabolic activation, and 6.25 to 150 \ig/m\ for the 24-hour exposure group in the absence of metabolic activation. The maximum dose level used was limited by test material-induced toxicity. Precipitate of test material was not observed at any of the dose levels in the Mutagenicity Test. The vehicle (solvent) controls had acceptable mutant frequency values that were within the normal range for the L5178Y cell line at the TK +/- locus. The positive control materials induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system. The test material did not induce any toxicologically significant dose-related increases in the mutant frequency at any dose level, either with or without metabolic activation, in any of the three exposure groups. The test material was considered to be non-mutagenic to L5178Y cells under the conditions of the test.
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