Disodium 2-(3-oxo-6-oxidoxanthen-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:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

MUTAGENICITY IN SALMONELLA OF FLUORESCENT DYE TABLETS USED IN WATER TRACING

Author:

Eagle R. Nestmann , David J. Kowbel And Jennmm Ellenton

Year:

1980

Bibliographic source:

Water Research Vol. 14. pp. 901 to 902, 1980

Materials and methods

Principles of method if other than guideline:

Mutagenecity study was conducted to study the effects of sodium fluorescein on bacterial strains using Ames test.

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Fluorescein sodium

IUPAC Name:

Fluorescein sodium

Constituent 2

Reference substance name:

Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate

EC Number:

208-253-0

EC Name:

Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate

Cas Number:

518-47-8

Molecular formula:

C20H12O5.2Na

IUPAC Name:

disodium 3-oxo-3H-spiro[2-benzofuran-1,9'-xanthene]-3',6'-diolate

Test material form:

other: Solid

Details on test material:

- Name of test material (as cited in study report): Sodium fluorescein
- Molecular formula (if other than submission substance : C20-H10-Na2-O5
C20-H10-O5.2Na
C20-H12-O5.2Na
- Molecular weight (if other than submission substance): 376.274 g/mol
Substance type: Organic
Physical state: Solid
Purity: No data available
- Impurities (identity and concentrations): No data available

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 1538, TA98, TA1537, TA1535, and TA100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not applicable

Test concentrations with justification for top dose:

10mg/plate

Vehicle / solvent:

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

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

4-nitroquinoline-N-oxide

benzo(a)pyrene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- 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: Partial lethality observed

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

OTHER: No data available

Evaluation criteria:

Based on Dose related increase in His revertants

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA1538, TA98, and TAI00,TA 1537 and TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Partialy lethal

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data available
- Effects of osmolality: No data available
- Evaporation from medium: No data available
- Water solubility: No data available
- Precipitation: No data available
- Other confounding effects: No data available

RANGE-FINDING/SCREENING STUDIES: No data available

COMPARISON WITH HISTORICAL CONTROL DATA: No data available

ADDITIONAL INFORMATION ON CYTOTOXICITY: Partial lethality was observed by reductions in the His- background in some bacterial strains at the dose of 10mg/plate.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Sodium fluorescein is non mutagenic in the Ames test performed for the Salmonella typhimurium TA1538, TA98, and TA100,TA 1537 and TA 1535.

Executive summary:

The fluorescent dyeSodium fluorescein issold for public, commercial, and field use, in liquid and tablet forms, for sewage, plumbing, and water pollution tracing. Ames test was conducted to evaluate the mutagenic capability of sodium fluorescein. The dose concentration used was 10mg/plate using water as vehicle. No increase in number of revertants observed indicating the substance to be non mutagenic with or without activation. Sodium fluorescein is non mutagenic in the Ames test performed for theSalmonella typhimuriumTA1538, TA98, and TA100,TA 1537 and TA 1535.

 

In accordance with CLP classification, the test material does not classify as a mutagen.