1,1'-{(phenylmethanediyl)bis[(3-substituted benzene-4,1-diyl)diazene-2,1-diyl{1-[3-(dimethylamino)propyl]-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridine-5,3-diyl}]}dipyridinium chloride lactate salts

Endpoint summary

Additional information

Short description of key information:
Ames test (OECD 471):
4 Strains Salmonella typhimurium, 1 Strain Escherichia coli, two main experiments (plate incorporation and preincubation method), both with and without metabolic activation (S9 mix) at non-toxic and cytotoxic test substance concentrations.
Result: negative.
Chromosome aberration test in V79 Chinese hamster lung fibroblasts (OECD 473):
Two main experiments, both with and without metabolic activation (S9 mix) at non-toxic and cytotoxic test substance concentrations.
Exposure duration 4 h or 20 h, fixation 20 h after treatment start. In general, 100 metaphases per culture amounting to 200 metaphases per dose concentration were assayed for structural chromosomal aberrations and polyploidy.
Result: negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In view of negative results in the two experiments of a standard Ames bacterial mutation test and the two experiments of an in vitro chromosomal aberration test, all with and without metabolic activation at non-toxic and cytotoxic test substance concentrations, there was no indication of genotoxicity of the test substance. Consequently, there was no labelling requirement regarding mutagenicity. Data from in vivo tests are not available and not required at the tonnage band foreseen for this test substance.