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Toxicological information

Genetic toxicity: in vitro

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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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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:
other: TA 1538, TA98, TA1537, TA1535, and TA100
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain characteristics:
not applicable
Test concentrations with justification for top dose:
10mg/plate
Vehicle:
- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: No data available
Controls
Negative controls:
not specified
Solvent 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 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:
other: TA1538, TA98, and TAI00,TA 1537 and TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
Partialy lethal
Vehicle controls valid:
yes
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
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.

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.