Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

Methodology for the testing of food dyes for genotoxic activity: experiments with RED 2G (C.I. 18050)

Author:

R.B. Haveland-Smith, R.D. Combes, B.A. Bridges

Year:

1979

Bibliographic source:

Mutation Research, 64 , 241—248

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Evaluation of mutagenicity of test chemical in Salmonella typhimurium strain TA1538 in a Fluctuation test.

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Red 2G

IUPAC Name:

Red 2G

Constituent 2

Reference substance name:

Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

EC Number:

223-098-9

EC Name:

Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

Cas Number:

3734-67-6

Molecular formula:

C18H13N3Na2O8S2

IUPAC Name:

disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate

Test material form:

not specified

Details on test material:

- Name of test material: Red 2G
- Molecular formula: C18H15N3O8S2.2Na
- Molecular weight: 509.426 g/mol
- Substance type: Organic
- Physical state: Aqueous solutions or suspensions
- Purity: 80%
- Impurities (identity and concentrations): As, Pb ,Sb, BaSO4, Cr, Cu, Zn,Free aromatic amines, Synthetic intermediates (excluding free aromatic amines),Subsidiary colours were present.

Method

Target gene:

Histidine

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 specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix consisted of calcium-precipitated microsome from liver of male Sprague-Dawley rats.

Test concentrations with justification for top dose:

Without S9: 10 mg/mlWith S9. 1 or 10 mg/ml

Vehicle / solvent:

Deionised water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Without S9: Rimmel Mahogany Silk; With S9: 2-acetylaminofluorene

Details on test system and experimental conditions:

METHOD OF APPLICATION: In mediumDURATION- Preincubation period: Overnight (without S9) or overnight (with S9)- Exposure duration: 72 hrs (without S9) or 96 hrs (with S9)- Expression time (cells in growth medium): 72 hrs (without S9) or 96 hrs (with S9)- 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: No data availableOTHER EXAMINATIONS:- Determination of polyploidy: No data available- Determination of endoreplication: No data available- Other: No data availableOTHER: No data available

Rationale for test conditions:

No data available

Evaluation criteria:

The tubes were scored for turbidity. When dyes such as Red 2G was used in this system, it may be impossible to detect the turbidity in the tubes by eye or to use a growth indicator such as bromothymol blue, due to masking by the color. In this case, the presence of viable prototrophic revertants was verified by streaking loopfuls from each tube onto non-supplemented agar.

Statistics:

Yes ,Mean was observed.

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:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No data available

Remarks on result:

other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:

Test chemical was considered to be negative for mutagenic effects in Salmonella typhimurium strain TA1538 with and without metabolic activation.

Executive summary:

In a Mutagenicity test, the mutagenic effect of test chemical was evaluated in Salmonella typhimurium strain TA1538 utilizing a Fluctuation test. The bacteria were exposed to the test compound at the concentration of 1 or 10 mg /ml in presence or absence of metabolic activation. At the end of the study, the tubes were scored for turbidity. When dyes such as Red 2G was used in this system, it may be impossible to detect the turbidity in the tubes by eye or to use a growth indicator such as bromothymol blue, due to masking by the colour. In this case, the presence of viable prototrophic revertants was verified by streaking loop full from each tube onto non-supplemented agar. As seen by the results, no mutagenic effects of Red 2G were found at 1 or 10 mg/ml in the absence or presence of metabolic activation. Hence, test chemical is considered to be negative for mutagenic effects in Salmonella typhimurium strain TA1538 with and without metabolic activation.