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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
modified version for Azo Dyes
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
-
EC Number:
431-440-5
EC Name:
-
IUPAC Name:
(3-{5-[(E)-2-(3-{4-[(E)-2-{1-[3-(dimethylazaniumyl)propyl]-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl}diazen-1-yl]benzamido}phenyl)diazen-1-yl]-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridin-1-yl}propyl)dimethylazanium (3-{6-hydroxy-5-[(E)-2-(3-{4-[(E)-2-{2-hydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]-6-oxo-1,6-dihydropyridin-3-yl}diazen-1-yl]benzamido}phenyl)diazen-1-yl]-4-methyl-2-oxo-1,2-dihydropyridin-1-yl}propyl)(methyl)azanium (3-{6-hydroxy-5-[(E)-2-(4-{3-[(E)-2-{2-hydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]-6-oxo-1,6-dihydropyridin-3-yl}diazen-1-yl]benzamido}phenyl)diazen-1-yl]-4-methyl-2-oxo-1,2-dihydropyridin-1-yl}propyl)dimethylazanium hexaacetate

Method

Target gene:
TA 1537: his C 3076; rfa-; uvrB-; TA 98: his D 3052; rfa-; uvrB-; R-factor; TA 1535: his G 46; rfa-; uvrB-; TA 100: his G 46; rfa-; uvrB-; R-factor;
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 liver fractions of rats induced with phenobarbital/ ß-Naphthoflavone
Test concentrations with justification for top dose:
Experiment I: 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment II: 10, 33, 100, 333, 1000 and 1500 µg/ plate;
Experiment III: 200, 400, 600, 800, 1000 and 1200 µg/plate;

Vehicle / solvent:
Deionised water
Details on test system and experimental conditions:
Experiment I: plate incorporation test;
Experiment II and III: Pre-Incubation test;

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 333 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 100 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 333 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 100 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
Metabolic activation system:
Experiment 1: S9 liver fractions of rats, induced with phenobarbital/ .beta.-naphthoflavone;
Experiment II and III: S9 liver fractions of Syrian golden hamsters, untreated;
Observations: Due to borderline observations in Experiment II, a third experiment was performed to verify these effects;
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: preliminary test

Applicant's summary and conclusion

Conclusions:
Interpretation of results:
negative with metabolic activation
negative without metabolic activation