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EC number: 210-042-3 | CAS number: 603-47-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- 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
Referenceopen allclose all
- 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
- Reference Type:
- publication
- Title:
- Gentian Violet: A 19th Century Drug Re-Emerges in the 21st Century
- Author:
- Alexander M. Maley et al
- Year:
- 2 013
- Bibliographic source:
- Exp Dermatol. 2013 December ; 22(12): 775–780
- Reference Type:
- other: abstract
- Title:
- Chronic toxicity and carcinogenicity studies of gentian violet in mice.
- Author:
- Littlefield et al
- Year:
- 1 985
- Bibliographic source:
- Fundam Appl Toxicol. 1985 Oct;5(5):902-12.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- GLP compliance:
- not specified
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:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 720 male and 720 female mice
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- ethanol
- Details on exposure:
- Gentian violet was dissolved in ethyl alcohol and sprayed directly into the feed at dose levels of 0, 100, 300 and 600 ppm. The ethyl alcohol was subsequently removed during a 30-minute blending process under vacuum.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 12 months (120 mice/sex), 18 months (120 mice/sex) and 24 months (480 mice/sex)
- Frequency of treatment:
- Daily consumption of food containing gentian violet
- Post exposure period:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 ppm
- Remarks:
- The dose represents approximately 100 mg of gentian violet/kg bw/week (females) and 75 to 100 mg of gentian violet/kg bw/week (males)
- Dose / conc.:
- 300 ppm
- Remarks:
- The dose represents approximately 250-275 mg of gentian violet/kg bw/week (females) and 225 to 250 mg of gentian violet/kg bw/week (males)
- Dose / conc.:
- 600 ppm
- Remarks:
- The dose represents approximately 500 mg of gentian violet/kg bw/week (females) and 450 to 475 mg of gentian violet/kg bw/week (males)
- No. of animals per sex per dose:
- Both sexes of mice received all 4 doses (120 males, 120 females)
- Control animals:
- yes
- Positive control:
- not specified
Examinations
- Observations and examinations performed and frequency:
- not specified
- Sacrifice and pathology:
- not specified
- Statistics:
- Yes but the method is not specified
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- A dose effect was noted for mortality rates. For controls, mortality of both sexes was less than 15% at 24 months but was approximately 28%, 27% and 64% in females in the 100, 300 and 600 ppm dose groups, respectively. For males, mortality was 14%, 20% and 23% in the 100, 300 and 600 ppm dose levels, respectively. Females appeared to be more susceptible than males.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- In males at 24 months and in females at 18 and 24 months at the 300 and 600 ppm dose levels, respectively, liver neoplasms were observed.
In female mice, erythropoiesis in the spleen, atrophy of the ovaries, adenoma of the Harderian gland, and the presence of type A reticulum cell sarcomas in the urinary bladder, uterus ovaries and vagina were seen. - Relevance of carcinogenic effects / potential:
- A positive dose response for hepatocellular carcinoma was noted in males at 24 months and in females at 18 and 24 months at the 300 to 600 ppm doses. There were statistically significant positive trends with respect to dose and (1) mortality due to liver neoplasms, (2) prevalence of liver neoplasms, and (3) time to onset of liver neoplasms in both males and females.
The estimation of risk of 10(-6) over background for malignant liver neoplasms using linear extrapolations showed a lower bound on the virtually safe dose (VSD) to be 2 ppb for the female mice and 1 ppb for the male mice. For benign and malignant liver tumors together, the lower bound on the VSD was essentially the same as for malignant liver neoplasm alone.
The authors concluded that gentian violet appeared to be a carcinogen in mice at several different sites.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 100 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
Target system / organ toxicity
open allclose all
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 300 ppm
- System:
- hepatobiliary
- Organ:
- liver
- spleen
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 300 ppm
- System:
- female reproductive system
- Organ:
- ovary
- uterus
- vagina
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 300 ppm
- System:
- eye
- Organ:
- other: Harderian gland
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 300 ppm
- System:
- urinary
- Organ:
- bladder
- Treatment related:
- yes
- Dose response relationship:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the different effects observed when gentian violet was administered to mice at doses up to 600 ppm, the authors concluded that the substance appeared to be a carcinogen in mice at several different sites, especially the liver.
(Littlefield et al, 1985)
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