Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate

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 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:

Fd. Cosmet. Toxicol. Vol. 18, pp. 218 to 221, 1979

Materials and methods

Principles of method if other than guideline:

The induction of mutations was studied in modified liquid fluctuation tests a histidine auxotroph of Salmonella typhimurium (specific for frameshifts) for the test compound Carmoisine.

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate

EC Number:

222-657-4

EC Name:

Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate

Cas Number:

3567-69-9

Molecular formula:

C20H12N2Na2O7S2

IUPAC Name:

disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate

Details on test material:

- Name of test material (as cited in study report): Carmoisine
- Molecular formula (if other than submission substance): C20H14N2O7S2.2Na
- Molecular weight (if other than submission substance): 502.4338 g/mol
- Substance type: organic
- Physical state: No data available
Purity No data available
- Impurities (identity and concentrations): No data available

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1538

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Test concentrations with justification for top dose:

5 mg/mL

Vehicle / solvent:

Vehicle
Deionised water
- Justification for choice of solvent/vehicle: No data available

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: No data available
- Exposure duration: 72-96 hrs
- Expression time (cells in growth medium): 72-96 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 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: The food colour was made up in deionized water and membrane-sterilized prior to use. The test material was tested at its maximum sublethal concentration.

Evaluation criteria:

The test material was considered positive only if it resulted in significant more turbid tubes in a treated series when compared with an untreated set of tubes

Statistics:

Chi square test

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: strain/cell type:

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Carmoisine failed to induce gene mutation in the bacterial tester strain Salmonella typhimurium TA 1538 and hence is negative for gene mutation in vitro both in the presence and absence of metabolic activation system.

Executive summary:

Fluctuation test was performed for the test chemical Carmoisine used at a concentration of 5 mg/mL in liquid medium for 72-96 hrs. The tester strains used wereSalmonella typhimuriumTA 1538 both in thepresence and absence of metabolic activation system. The assay was performed for each bacterium in three separate experiments.

 

The given test material failed to induce genotoxicity in the bacteria Salmonella typhimuriumTA 1538 and hence is negative for gene mutation in vitro.