Registration Dossier
Registration Dossier
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EC number: 210-042-3 | CAS number: 603-47-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Final report on the safety assessment of Basic Violet 1, Basic Violet 3, and Basic Violet 4
- Author:
- C. Diamante et al.
- Year:
- 2 009
- Bibliographic source:
- International Journal of Toxicology, 28(Suppl 3) 193s-204s
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-[[4-(dimethylamino)phenyl][4-(methylimino)cyclohexa-2,5-dien-1-ylidene]methyl]-N,N-dimethylaniline monohydrochloride
- EC Number:
- 210-042-3
- EC Name:
- 4-[[4-(dimethylamino)phenyl][4-(methylimino)cyclohexa-2,5-dien-1-ylidene]methyl]-N,N-dimethylaniline monohydrochloride
- Cas Number:
- 603-47-4
- Molecular formula:
- C24H27N3.ClH
- IUPAC Name:
- 4-[[4-(dimethylamino)phenyl][4-(methylimino)cyclohexa-2,5-dien-1-ylidene]methyl]-N,N-dimethylaniline monohydrochloride
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (no additional information)
- Test concentrations with justification for top dose:
- 0.32, 1, 3.2 and 10 ug/plate
- Vehicle / solvent:
- Not specified
Controls
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- other: bêta-propiolactone
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- When tested on Salmonella typhimurium (strains TA98, TA100, TA1535, TA1537, TA1538), Basic Violet 1 was mutagenic only in TA1535 at low chemical concentrations in the absence of S9
(Bonin et al., 1981)
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