2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate

Genetic toxicity: in vitro

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:

1983

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:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-[4-(diethylammonio)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium oxalate

EC Number:

281-588-8

EC Name:

2-[2-[4-(diethylammonio)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium oxalate

Cas Number:

83969-11-3

Molecular formula:

C23H29N2.C2HO4

IUPAC Name:

2-{2-[4-(diethylammonio)phenyl]vinyl}-1,3,3-trimethyl-3H-indolium oxalate

Test material form:

solid: particulate/powder

Details on test material:

Basic Violet 16

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from rat liver

Test concentrations with justification for top dose:

1, 5, 10, 50, 100, 500 µg/plate

Vehicle / solvent:

water

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2-Aminoanthracene; 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, 4-nitro-o-phenylenediamine

Details on test system and experimental conditions:

Bacterial strains
Salmonella typhimuriurn TA100, TA98, TA1535, TA1537 and TA1538 were obtained from Professor B.N. Ames, University of California, U.S.A.
Escherichia coli WP2 uvrA was provided by Dr. T. Kada, National Institute of Genetics, Mishima, Japan.

Cultures of each strain were prepared by incubating an aliquot of parent stock culture in nutrient broth at 37°C for 18 hours.

After mixing 0.1 ml of test material solution, 0.5 ml of phosphate buffer or S-9 mix, 0.1 ml of culture of tester strain, and 2 ml of top agar in a test tube, the mixture was poured on minimal agar plate. The plates were incubated at 37°C for 2 days and scored, for revertants.

For each concentrations 2 plates were prepared and scored.

Results and discussion

Test results

Test results 1

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 6

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Under the study conditions, the test substance was found to be not mutagenic in the bacterial reverse mutation assay.

Executive summary:

A bacterial reverse mutation assay (Ames) was carried out, to evaluate the test substance for the mutagenic potential in a microbial assay with and without the addition of mammalian metabolic activation preparation. The test was carried out in strains of Salmonella typhimuriurn TA100, TA98, TA1535, TA1537 and TA1538 and Escherichia coli WP2 uvrA. Cultures of each strain were prepared by incubating an aliquot of parent stock culture in nutrient broth at 37°C for 18 hours. After mixing 0.1 ml of test material solution, 0.5 ml of phosphate buffer or S-9 mix, 0.1 ml of culture of tester strain, and 2 ml of top agar in a test tube, the mixture was poured on minimal agar plate. The plates were incubated at 37°C for 2 days and scored, for revertants.

Cytotoxicity was observed at concentations of 100 and 500 µg/plate. The test substance was tested negative with and without metabolic activation in all strains tested.