3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium 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:

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:

Mutagenicity Test of Dyes used in Cosmetics with the Salmonella/Mammalian-Microsome Test

Author:

Jeanne M. Muzzall and Warren L. Cook

Year:

1979

Bibliographic source:

Mutation Research, 67 (1979) 1-8

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Salmonella/ mammalian-microsome test was performed to evaluate the mutagenic nature of the test compound D & C Red no. 27 as per the plate incorporation assay

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one

EC Number:

236-747-6

EC Name:

2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one

Cas Number:

13473-26-2

Molecular formula:

C20H4Br4Cl4O5

IUPAC Name:

2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material : D & C Red no. 27
- Molecular formula : C20H4Br4Cl4O5
- Molecular weight : 785.6746 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available

Specific details on test material used for the study:

- Name of test material : D & C Red no. 27
- Molecular formula : C20H4Br4Cl4O5
- Molecular weight : 785.6746 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available

Method

Target gene:

No data available

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98, TA1537, TA100, TA1535

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not applicable

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

The microsomal fraction (S9) was prepared from male Sprague-Dawley rats weighing approximately 200 g each.

Test concentrations with justification for top dose:

10-250 mg

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data available
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 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: No data available

Rationale for test conditions:

No data available

Evaluation criteria:

Materials which caused a 2-fold increase of revertants, as compared to the number of spontaneous revertants on the control plates, were denoted as mutagens. Those which reduced the number of revertants were considered inhibitory.

Statistics:

No data available

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98, TA1537, TA100, TA1535

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:

not specified

Additional information on results:

No data available

Applicant's summary and conclusion

Conclusions:

D and C Red no. 27 did not induce gene mutation in Salmonella typhimurium TA98, TA1537, TA100, TA1535 in the plate incorporation assay both in the presence and absence of S9 metabolic activation system and hence is negative for gene mutation in vitro.

Executive summary:

Salmonella/ mammalian-microsome test was performed to evaluate the mutagenic nature of the D and C Red no. 27. The 2 ml of liquid top agar was cooled to 45°C and 0.1 ml of a broth culture of microorganism and test substance at dose level of 10 -250 mg and in volumes of ≤ 0.4 ml of DMSO was added prior to placing on minimal agar plates. After 48 h incubation at 37°C, the colonies which reverted to the prototroph were counted and compared to counts on the control plate (containing no test substance) to demonstrate mutagenicity or toxicity. Materials which caused a 2-fold increase of revertants, as compared to the number of spontaneous revertants on the control plates, were denoted as mutagens. Those which reduced the number of revertants were considered inhibitory. D and C Red no. 27 did not induce gene mutation in Salmonella typhimurium TA98, TA1537, TA100, TA1535 in the plate incorporation assay both in the presence and absence of S9 metabolic activation system and hence is negative for gene mutation in vitro.