Registration Dossier
Registration Dossier
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EC number: 210-042-3 | CAS number: 603-47-4
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- 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:
- EPA OTS 798.5915 (In Vivo Sister Chromatid Exchange Assay)
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange 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
Test animals
- Species:
- hen
- Strain:
- other: K-strain chicken
- Sex:
- not specified
Administration / exposure
- Route of administration:
- other: gentian violet was applied to the inner shell membrane of chicken embryos
- Vehicle:
- water
- Details on exposure:
- Embryos grew in the presence of 0.5 to 10 ug of gentian violet over the experimental period of 22 hours but were colored purple by this dye.
- Duration of treatment / exposure:
- 22 hours
- Frequency of treatment:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.5 other: ug/embryo
- Dose / conc.:
- 2 other: ug/embryo
- Dose / conc.:
- 5 other: ug/embryo
- Dose / conc.:
- 10 other: ug/embryo
- Dose / conc.:
- 20 other: ug/embryo
- Dose / conc.:
- 100 other: ug/embryo
- Dose / conc.:
- 1 000 other: ug/embryo
- Dose / conc.:
- 2 000 other: ug/embryo
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Positive control(s):
- not specified
Examinations
- Tissues and cell types examined:
- not specified
Results and discussion
Test results
- Key result
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- toxicity through growth inhibition at dosages of 20, 100, 1000 and 2000 ug
- Additional information on results:
- Only one embryo survived at 100 ug and it did not show a significant increase in sister chromatid exchange.
No signs of chromosome breakage were seen in embryos exposed to 0.5 to 10 ug of Gentian Violet.
Applicant's summary and conclusion
- Conclusions:
- Gentian violet did not induce sister chromatid exchanges when administered to chicken embryos at doses of 0.5 to 2000 ug per embryo. However, gentian violet was very toxic by completely inhibiting growth at doses of 20 to 2000 ug. No signs of chromosome breakage were seen in embryos exposed to 0.5 to 10 ug of gentian violet.
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