Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate]

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:

weight of evidence

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. 21

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-(3,6-dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid

EC Number:

239-138-3

EC Name:

2-(3,6-dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid

Cas Number:

15086-94-9

Molecular formula:

C20H8Br4O5

IUPAC Name:

2-(2,4,5,7-tetrabromo-3,6-dihydroxy-9H-xanthen-9-yl)benzoic acid

Constituent 2

Reference substance name:

D & C Red no. 21

IUPAC Name:

D & C Red no. 21

Details on test material:

- Name of test material (as cited in study report): D & C Red no. 21
- Molecular formula (if other than submission substance): C20-H8-Br4-O5
- Molecular weight (if other than submission substance): 647.8942 g/mol
- Substance type: Organic
- Physical State: Solid

Specific details on test material used for the study:

- Name of test material: D & C Red no. 21
- Molecular formula: C20H8Br4O5
- Molecular weight: 647.8942 g/mol
- Substance type: Organic
- Physical State: Solid

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

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: Plate incorporation assay

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

Evaluation criteria:

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

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

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

Remarks on result:

other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

D and C Red no. 21 did not induce gene mutation in Salmonella typhimurium TA98, TA1537, TA100, TA1535 in the presence and absence of S9 metabolic activation system and hence it is negative for gene mutation in vitro.

Executive summary:

Salmonella/ mammalian-microsome test was performed to evaluate the mutagenic nature of the test compound D&C Red No. 21. The study was performed as per the plate incorporation method using Salmonella typhimurium strains TA98, TA1537, TA100, TA1535 with and without S9 metabolic activation system. The test material was dissolved in DMSO and used at dose levels from 10-250 mg. DMSO was used as the solvent control.

 

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 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. 21 did not induce gene mutation in Salmonella typhimurium TA98, TA1537, TA100, TA1535 in the presence and absence of S9 metabolic activation system and hence it is negative for gene mutation in vitro.