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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
Study period:
1998-May-12 to 1998-Jun-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
-
EC Number:
431-830-5
EC Name:
-
Molecular formula:
C28H18F2N8Na4O16S5
IUPAC Name:
octasodium 4-amino-6-(2-{5-[(2,6-difluoropyrimidin-4-yl)amino]-2-sulfophenyl}diazen-1-yl)-5-hydroxy-3-(2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2,7-disulfonate 4-amino-6-(2-{5-[(4,6-difluoropyrimidin-2-yl)amino]-2-sulfophenyl}diazen-1-yl)-5-hydroxy-3-(2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Reaktiv Marineblau FC 63805

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix aus Rattenleber "ENGLISH" S9-mix made form rat liver
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 4, 20, 100, 500, 2500, 5000 µg/plate
Concentration range in the main test (without metabolic activation): 4, 20, 100, 500, 2500, 5000 µg/plate
Vehicle / solvent:
Solvent: Dest. Wasser
Controls
Untreated negative controls:
yes
Remarks:
untreated control
Negative solvent / vehicle controls:
yes
Remarks:
0 ug/plate
Positive controls:
yes
Remarks:
Without metabolic activation: sodium-azide for strain TA 100 and TA 1535, 9-aminoacridine for strain TA 1537, 2-nitrofluorene for strain TA 98. With metabolic activation: 2-aminoanthracene for all strains
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: incubaton for 48 h

SELECTION AGENT (mutation assay): revert mutation

NUMBER OF REPLICATIONS:
-3 plates per strain per concentration
Evaluation criteria:
The test compound is classified as mutagenic if:
- The test compound produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn.
OR
- The test compound induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn.
Statistics:
means and standard deviations reported

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Reactive Navy FC 63805 is not mutagenic with or without metabolic activation based on the Ames test.
Executive summary:

In a reverse gene mutation assay in bacteria, strains TA 98, 100, 1535, 1537 of S. typhimurium were exposed to Reactive Navy FC 63805 at concentrations of 4, 20, 100, 500, 2500, 5000 µg/plate in the presence and absence of mammalian metabolic activation.  There was no evidence of induced mutant colonies over background. The positive controls induced the appropriate responses in the corresponding strains.

This study is classified as acceptable and satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.