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EC number: 208-953-6 | CAS number: 548-62-9
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- Teratology and percutaneous toxicity studies on hair dyes
- Author:
- C. Burnett , E. I. Goldenthal , S. B. Harris , F. X. Wazeter , J. Strausburg , R. Kapp & R. Voelker
- Year:
- 1 976
- Bibliographic source:
- Journal of Toxicology and Environmental Health,1, 1027-1040, 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of Gentian violet using Charles River CD female rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- [4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- EC Number:
- 208-953-6
- EC Name:
- [4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- Cas Number:
- 548-62-9
- Molecular formula:
- C25H30ClN3
- IUPAC Name:
- 4-{bis[4-(dimethylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium chloride
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):Gentian violet
- IUPAC name: N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride
- Molecular formula : C25H30N3.Cl
Molecular weight : 407.986 g/mol
- Smiles notation: C(\c1ccc(N(C)C)cc1)(c1ccc(N(C)C)cc1)=C1\C=C\C(=[N+](/C)C)C=C1.[ClH-]
- InChl:1S/C25H30N3.ClH/c1-26(2)22-13-7-19(8-14-22)25(20-9-15-23(16-10-20)27(3)4)21-11-17-24(18-12-21)28(5)6;/h7-18H,1-6H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : Basic violet 3
- Molecular formula : C25H30ClN3
- Molecular weight : 407.986 g/mol
- Substance type: Organic
- Physical state: No data
- Impurities (identity and concentrations): No data
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
- Details on species / strain selection:
- No data
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: the mated female animals were housed individually in temperature- and
humidity-controlled rooms
- Diet (e.g. ad libitum): Ralston Purina Laboratory Chow ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled environment
- Humidity (%):Controlled environment
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on exposure:
- TEST SITE
- Area of exposure: The dorso-scapular area
- % coverage: No data
- Type of wrap if used: No data
- Time intervals for shavings or clipplings: The hair at the site of application on the dorso-scapular area was shaved closely the day prior to application
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg of the P-23 dye formulation
- Concentration (if solution): 0.002% (2.0 mg/Kg)
- Constant volume or concentration used: No data
- For solids, paste formed: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data
USE OF RESTRAINERS FOR PREVENTING INGESTION: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- Duration of treatment: 19 days
Duration of exposure: 1, 4, 7, 10, 13, 16 and 19 day of gestation - Frequency of treatment:
- Once on days 1, 4, 7, 10, 13, 16 and 19 of gestation
Doses / concentrations
- Remarks:
- 0.002% (0.00942 mg/Kg)
- No. of animals per sex per dose:
- Total: 100
0 mg/Kg: 60 female rats
2.0 mg/Kg: 20 female rats
Positive control: 20 female rats - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- Acetylsalicylic acid
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: No data
BODY WEIGHT: Yes
- Time schedule for examinations: 1, 4, 7, 10, 13, 16 and 19 day of gestation
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY:
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data - Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY:
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: No data sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- All statistical analyses compared the treatment groups with the control groups. Statistically significant differences between groups were judged valid only when there were significant differences between any one of the dye treated groups and each of the three untreated control groups.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- 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:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality
Clinical signs: No signs of toxicity were noted during the study period
Mortality: No data
Dermal irritation: No irritation or other changes in appearance were noted except for changes in skin and hair color at the site of topical application of the dye formulation
Body weight and weight gain: Changes in female body weights were similar for rats in the untreated controls and all dye-treated groups at 0.00942 mg/Kg.
Food consumption and compound intake: Mean food consumption for all groups throughout gestation was similar
Food efficiency: No data
Water consumption and compound intake: No data
Opthalmoscopic examination: No data
Haematology: No data
Clinical chemistry: No data
Urinanalysis: No data
Neurobehaviour: No data
Organ weights: No data
Gross pathology: No data
Histopathology: No data
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 0.009 other: mg/Kg
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No evidence of compound-induced toxicity was observed
- Remarks on result:
- other: No adverse effects were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for gentian violet in female Charles River CD rats is considered to be 0.00942 mg/Kg.
- Executive summary:
Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of Gentian violet. The study was performed using female Charles River CD rats. 2 mL/Kg dye formulation P-23 containing 0.002% ( 0.00942 mg/Kg) test compound was applied to the dorso-scapular area. The application was made during the gestation days 1, 4, 7, 10, 13, 16 and 19. The animals were observed for clinical signs, body weight changes, dermal irritation if any and food consumption. No dye formulation related toxicity was noted. Changes in female body weights and food consumption were similar for rats in the untreated controls and all dye-treated groups. No irritation or other changes in appearance were noted except for changes in skin and hair color at the site of topical application of the dye formulation. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for gentian violet in female Charles River CD rats is considered to be 0.00942 mg/Kg.
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