Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-[(4-methyl-3-sulphonatophenyl)sulphonyl]phenyl]azo]naphthalene-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:

07 April 1987

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:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only four tester strains tested; no tester strain to detect cross-linking mutagens was included

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate

Cas Number:

85187-33-3

Molecular formula:

C26H19BrN4Na2O9S3

IUPAC Name:

Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Identity - FAT 40066/E TE
Batch - SBL009/LR6G (India)
Appearance - brown powder, solid at 20 °C
Smell - neutral
pH-Value - pH-value of a soln. of 2% (w/w) = 5.2
Expiration date - December 18th, 2018
Storage - to be stored at room-temperature

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:

S-9 mix from liver

Test concentrations with justification for top dose:

20 to 5120 µg per Petri dish

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive control substance:

other: 2-anthramine (6.25 µg))

Remarks:

For strains TA 1535, TA 1537, TA 98 and TA 100 - with metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

for strain TA 1535 and TA 100 - without metabolic activation

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

For strain TA 1537 - without metabolic activation

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Daunomycine

Remarks:

For strain TA 98 - without metabolic activation

Evaluation criteria:

The criteria of mutagenicity used in this test are a doubling of the spontaneous reversion rate accompanied by a dose-effect relationship.

Statistics:

None

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Remarks:

and TA 100

Metabolic activation:

with

Genotoxicity:

positive

Remarks:

doubling of the spontaneous reversion was only noted at 5120 µg

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

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

Metabolic activation:

without

Genotoxicity:

positive

Remarks:

In the absence of S-9 mix a doubling of the spontaneous reversion was noted at 5120 µg with the strain TA 98. A mutagenic effect was observed with the strains TA 100 and TA 1537 over a concentration range of 1280 to 5120 µg of product per Petri Dish.

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

No mutagenic effect was observed with the strain TA 1535.
In the presence of S-9 mix a doubling of the spontaneous reversion was only noted at 5120 µg with the strains TA 100 and TA 1537.
In the absence of S-9 mix a doubling of the spontaneous reversion was noted at 5120 µg with the strain TA 98. A mutagenic effect was observed with the strains TA 100 and TA 1537 over a concentration range of 1280 to 5120 µg of product per Petri Dish.

Remarks on result:

other: four strains were used

Applicant's summary and conclusion

Conclusions:

FAT 40066/B was found mutagenic for S. typhimurium strains TA 1537, TA 98 and TA 100.

Executive summary:

The substance FAT 40066/B was tested with the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at concentrations from 20 to 5120 µg per Petri dish both in the presence and absence of metabolic activation. Under the experimental conditions defined in the protocol, and employing a doubling of the spontaneous reversion rate and dose-effect relationship as criteria of mutagenicity, the product FAT 40066/B was found mutagenic for S. typhimurium strains TA 1537, TA 98 and TA 100. No mutagenic effect was observed with the strain TA 1535. In the presence of S-9 mix a doubling of the spontaneous reversion was only noted at 5120 µg with the strains TA 100 and TA 1537. In the absence of S-9 mix a doubling of the spontaneous reversion was noted at 5120 µg with the strain TA 98. A mutagenic effect was observed with the strains TA 100 and TA 1537 over a concentration range of 1280 to 5120 µg of product per Petri Dish. A mutagenic effect was observed with the strains TA 100 and TA 1537 both in the absence and the presence of S-9 mix, and with the strain TA 98 at 5120 µg only in the absence of S-9 mix. Based on the study results, FAT 40066/B was found mutagenic for S. typhimurium strains TA 1537, TA 98 and TA 100.