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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
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:
Gene mutation toxicity study of the test chemical
Author:
Bakshi et al
Year:
2003
Bibliographic source:
Journal of Environmental Pathology, Toxicology and Oncology

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
The Ames salmonella typhimurium mutagenicity test was conducted for chemical
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Pink FG (CI Basic Red 13)
- IUPAC name: -(2-{4-[(2-chloroethyl)(methyl)amino]phenyl}vinyl)-1,3,3-trimethyl-3H-indolium chloride
- Molecular formula: C22H26ClN2Cl
- Molecular weight: 389.367 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data available
- Impurities (identity and concentrations):No data available

Method

Target gene:
Histdine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA102, and TA1535
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:
S9 metabolic activation system
Test concentrations with justification for top dose:
5–5000 μg/plate
Vehicle / solvent:
No data
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
sodium azide
mitomycin C
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation) with preincubation modification

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

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Yes, the cytotoxicity study were carried out by accounting for the microcolonies
(histidine auxotroph) in the background lawn. The sparse or absent growth indicated the toxic nature of dyes toward the tester strains.

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:
A dose-related increase (at least 2-fold) in revertant colonies was used to define a statistically significant mutagenic response.
Statistics:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98, TA100, TA102, and TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
≥ 500 μg
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data
Remarks on result:
other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:
The test chemical did not induce gene mutation in the Salmonella typhimurium TA98, TA100, TA102, and TA1535 both in the presence and absence of S9 activation system and hence the chemical is not likely to be a gene mutant.
Executive summary:

Ames mutagenicity test was conducted for the test chemical to evaluate its genotoxic effects when exposed to Salmonella typhimurium strains TA98, TA100, TA102, and TA1535 with dose concentration of 5–5000 µg/plate in plate incorporation assay. The plates were incubated for 48 h. The doses of test chemical, together with the appropriate concurrent positive controls, were tested in triplicate on each tester strain with and without S9 metabolic activation. A dose-related increase (at least 2-fold) in revertant colonies was used to define a statistically significant mutagenic response. The test chemical did not induce gene mutation in the Salmonella typhimuriumTA98, TA100, TA102, and TA1535 both in the presence and absence of S9 activation system and hence the chemical is not likely to be a gene mutant.