Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Screening of food dyes for Genotoxic activity

Author:

R. B. HAVELAND-SMITH and R. D. COMBES

Year:

1979

Bibliographic source:

Food and cosmetics toxicology, Vol-18, Page no: 215-221, 1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

In- vitro gene mutation toxicity test was performed for Green S by performng microsomal rec assay in E. coli strains

GLP compliance:

not specified

Type of assay:

other: Rec assay

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt

EC Number:

221-409-2

EC Name:

Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt

Cas Number:

3087-16-9

Molecular formula:

C27H26N2O7S2.Na

IUPAC Name:

Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Molecular formula :C27H26N2O7S2.Na
- Molecular weight: 576.623 g/mol
- Substance type:Organic
- Physical state:Solid

Specific details on test material used for the study:

- Name of the test material: Green S
- EC name: Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Molecular formula: C27H26N2O7S2.Na
- Molecular Weight: 576.623 g/mol
- Substance type: Organic
- Smiles: c12c(\C(c3ccc(N(C)C)cc3)=C3/C=C\C(=[N+](/C)C)C=C3)c(O)c(S(=O)(=O)[O-])cc1cc(S(=O)(=O)[O-])cc2.[Na+]

Method

Target gene:

Tryptophan

Species / strain

Species / strain / cell type:

E. coli, other: WP100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

other: trp uvrA recA

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

Calcium-precipitated microsomes from the livers of phenobarbitone-induced Sprague-Dawley rats

Test concentrations with justification for top dose:

0 or 10 mg/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Dimethylsulphoxide (DMSO)
- Justification for choice of solvent/vehicle: No data available

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

mitomycin C

other: Ethidium bromide (167 µg), furacin (1 µg)

Details on test system and experimental conditions:

METHOD OF APPLICATION: In agar (plate incorporation)

DURATION
- Preincubation period: No data available
- Exposure duration: 5.5 hours
- Expression time (cells in growth medium): Overnight
- 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 available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: No data available

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: No data available

Rationale for test conditions:

No data

Evaluation criteria:

Coefficient of survival was measured

Statistics:

No data

Results and discussion

Test results

Species / strain:

E. coli, other: WP100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

No data available

Applicant's summary and conclusion

Conclusions:

Green S failed to show mutation using E. coli WP100 trp uvrA rec A and hence is not likely to classify as a gene mutant in vitro.

Executive summary:

In- vitro gene mutation toxicity test was performed for Green S (EC name: Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt) by performng microsomal rec assay in E. coli strains. The rec assay was performed using E. coli WP100 trp uvrA recA. The bacteria was exposed for 5.5 hrs to 10 mg/mL Green S and then incubated overnight before the plates were counted. Green S failed to show mutation using E. coli WP100 trp uvrA rec A and hence is not likely to classify as a gene mutant in vitro.