Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 Sep, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only 4 tester strains tested, no tester strain to detect cross-linking mutagens included

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

274-397-6

EC Name:

Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

70209-99-3

Molecular formula:

C23H16BrN3O9S2.2Na

IUPAC Name:

disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

FAT 40'068/B

Specific details on test material used for the study:

- Test material identified as: FAT 40068/B

Method

Target gene:

Histidine-requiring strains of Salmonella typhimurium

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Activation mixture (rat liver microsomes and co-factors)

Test concentrations with justification for top dose:

25, 75, 225, 675, and 2025 μg/0.1 mL

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: TA 1535

Controls 2

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Controls 3

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Daunoblastin

Controls 4

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation).


DURATION
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS:
- Number of cultures per concentration: Triplicate
- Number of independent experiments : One

METHODS FOR MEASUREMENTS OF GENOTOXICIY : Colony counting

Rationale for test conditions:

As per the guidelines

Evaluation criteria:

The test substance was considered to be non-mutagenic if the colony count in relation to the negative control was not doubled at any concentration.

Statistics:

When the colonies had been counted, the arithmetic mean was calculated.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA 98, TA 100 and TA 1537

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

In the experiments without and with microsomal activation, treatment with FAT 40068/B led to an increase in the number of backmutant colonies of Strains TA 98, TA 100 and TA 1537. The highest incidence of back-mutant colonies was observed at the following drug-concentrations: Strain TA 98 at 2025 µg/0.1 ml and Strains TA 100 and TA 1537 at 675 µg/0.1 ml (without microsomal activation) and 2025 µg/0.1 ml (with microsomal activation).

Applicant's summary and conclusion

Conclusions:

FAT 40068/B was found to have mutagenic potential in this bacterial reverse mutation assay.

Executive summary:

Preparation FAT 40'068/B was tested for mutagenic effects on histidine- auxotrophic mutants of Salmonella typhimurium. This test was conducted in accordance to method similar to OECD TG 471. The investigations were performed with the following concentrations of the test substance with and without microsomal activation: 25, 75, 225, 675, and 2025 μg/0.1 mL. Appropriate positive controls were used for each strains. In the experiments performed without and with microsomal activation, 'the number of back-mutant colonies of strains TA 98, TA 100 and TA 1537 was significantly greater after treatment with FAT 40068/B than in the controls. Hence, it was concluded that FAT 40068/B exerted a clear-cut mutagenic action in this test system.