Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity of Arylmethane dyes in Salmonella

Author:

Antonio M. Bonin, Janice R. Farquharson And Robert S.U. Baker

Year:

1981

Bibliographic source:

Mutation Research, 89 (1981) 26-34

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Patent Blue V was tested in the Salmonella/ mammalian microsome mutagenicity assay to check for its mutagenic potential.

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt

EC Number:

204-934-1

EC Name:

Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt

Cas Number:

129-17-9

Molecular formula:

C27H32N2O6S2.Na

IUPAC Name:

hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt

Details on test material:

- Name of test material: Patent Blue V- Molecular formula: C27H31N2O6S2.NaC27H32N2O6S2.Na - Molecular weight (if other than submission substance): 566.672 g/mol- Substance type: Organic- Physical state: Solid- Purity: No data available- Impurities (identity and concentrations): No data available

Method

Target gene:

Salmonella/mammalian microsome mutagenicity assay

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Test concentrations with justification for top dose:

0, 32, 100, 320, 1000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

no

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2- acetylaminoflourene, β- propiolactone

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period: No data available- Exposure duration: 72 hrs- Expression time (cells in growth medium): 72 hrs- Selection time (if incubation with a selection agent): No data available - Fixation time (start of exposure up to fixation or harvest of cells): No data availableSELECTION AGENT (mutation assays): No data availableSPINDLE INHIBITOR (cytogenetic assays): No data availableSTAIN (for cytogenetic assays): No data availableNUMBER OF REPLICATIONS: No data availableNUMBER OF CELLS EVALUATED: No data availableDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No data availableOTHER EXAMINATIONS:- Determination of polyloidy: No data available- Determination of endoreplication: No data available- Other: No data availableOTHER: No data available

Evaluation criteria:

Criteria for mutagenicity were (a) a dose-response and, (b) reproducibility of the result. Dose-responses were not always evident at concentratrations selected for initial testing.

Statistics:

No data

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: Dose ranges for mutagenesis were determined first by preliminary pour-plate toxicity tests at 10, 1, 0.1, 0.01 mg/plate.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):negative with and withoutThe given test material is negative to induce mutagenicity in the Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 strains in the presence and absence of S9 mix.

Executive summary:

Salmonella/ mammalian microsome mutagenicity assay was performed to study the mutagenic potential of Patent Blue V both in the presence and absence of metabolic activator S9 mix. To each 2 ml of top agar at 42°C was added 100 µL bacterial broth culture, 100 µL test compound dissolved in DMSO various concentrations, and 500 µL S9 mix as required. Plates were incubated at 37°C for 72 hrs before counting his⁺revertant colonies and each dose point was determined from at least two plates, unless indicated otherwise. Criteria for mutagenicity were (a) a dose-response and, (b) reproducibility of the result. Dose-responses were not always evident at concentratrations selected for initial testing. Since no mutagenicity was detected, Patent Blue V is negative for the induction of gene toxicity in vitro. Hence the test chemical is not likely to classify for gene mutation in vitro..