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EC number: 947-403-6 | CAS number: -
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Genetic toxicity: in vitro
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:
- 2 003
- Bibliographic source:
- Journal of Environmental Pathology, Toxicology and Oncology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- 2-[2-[4-[(2-chloroethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride
- EC Number:
- 222-887-5
- EC Name:
- 2-[2-[4-[(2-chloroethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride
- Cas Number:
- 3648-36-0
- Molecular formula:
- C22H26ClN2.Cl
- IUPAC Name:
- 2-(2-{4-[(2-chloroethyl)(methyl)amino]phenyl}vinyl)-1,3,3-trimethyl-3H-indolium chloride
- 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
Constituent 1
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 modificationDURATION- 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 availableSELECTION AGENT (mutation assays): No data availableSPINDLE INHIBITOR (cytogenetic assays): No data availableSTAIN (for cytogenetic assays): No data availableNUMBER OF REPLICATIONS: TriplicateNUMBER OF CELLS EVALUATED: No data availableDETERMINATION 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 availableOTHER: 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.
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