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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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