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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)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity Testing of Some Commonly Used Dyes
Author:
King-Thom Chung, T George E. Fulk, And A. W. Andrews
Year:
1981
Bibliographic source:
Applied And Environmental Microbiology, Oct. 1981, P. 641-648 Vol. 42, No. 4

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
The results of mutagenicity testing of some dyes and their metabolites are determined by using the Salmonella-microsome mutagenicity test ()Plate incorporation method developed by Ames et al.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pyrazolone T
- Molecular formula (if other than submission substance): C10H8N2O6S
- Molecular weight (if other than submission substance): 284.26 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity ±96%

Method

Target gene:
No data avaialble
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 of male Sprague-Dawley rats stimulated with Aroclor 1254
Test concentrations with justification for top dose:
5 to 5000 µg.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: Plate incorporation

DURATION(for liquid preincubation assays)
- Preincubation period:
- Exposure duration: 30min at 37’c
- Expression time (cells in growth medium):No data
- Selection time (if incubation with a selection agent): No details
- Fixation time (start of exposure up to fixation or harvest of cells): No details
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: 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
Evaluation criteria:
A compound was considered mutagenic when the number of revertants above background was at least twice the value of the historical control mean or twice the value of the current control mean, whichever was greater, and a dose-response curve could be demonstrated
Statistics:
No data available

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100
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:
valid
Additional information on results:
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: Yes

ADDITIONAL INFORMATION ON CYTOTOXICITY: No data available
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 withand without

The test compound Pyrazolone T failed to induce mutation in the Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 with and without S9 activation system and hence is negative for gene mutation in vitro.
Executive summary:

Bacterial gene mutation assay was performed to evaluate the mutagenic nature of the test compound Pyrazolone T by the plate incorporation method. The test was performed using Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 with and without S9 activation system. After the treatment , the revertant colonies were counted by using a hand-held tally.

                                                          

The test compound Pyrazolone T failed to induce mutation in theSalmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 with and without S9 activation system and hence is negative for gene mutation in vitro.