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EC number: 224-618-7 | CAS number: 4430-18-6
- 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: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Acid Violet 43
- Author:
- Fiume MZ
- Year:
- 2 001
- Bibliographic source:
- International Journal of Toxicology, 20(Suppl. 3):1–6, 2001
Materials and methods
- Principles of method if other than guideline:
- Carcinogenic potential of the test compound Acid Violet 43 was evaluated on mice in 107 weeks study period
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Acid violet 43
- IUPAC Name:
- Acid violet 43
- Reference substance name:
- Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
- EC Number:
- 224-618-7
- EC Name:
- Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
- Cas Number:
- 4430-18-6
- Molecular formula:
- C21H15NO6S.Na
- IUPAC Name:
- sodium 2-[(4-hydroxy-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]-5-methylbenzenesulfonate
- Details on test material:
- - Name of test material (as cited in study report): Ext. D & C Violet No. 2- Molecular formula (if other than submission substance): C21H15NO6S.Na- Molecular weight (if other than submission substance): 431.399 g/mol- Substance type: organic- Physical state: No data availablePurity No data available- Impurities (identity and concentrations): Ext. D & C Violet No. 2 must be free of impurities except for the following: ≤ 18% volatile matter (at 135±C) and chlorides and sulfates (calculated as sodium salts); ≤ 0.4%water-insoluble matter; ≤ 0.2% 1-hydroxy-9,10-anthracenedione ; ≤ 0.2% 1,4-dihydroxy-9,10-anthracenedione; ≤ 0.1% p-toluidine; ≤ 0.2% p-toluidine sulfonic acids, sodium salts; ≤ 1% subsidiary colors;≤ 20 ppm lead (as Pb); ≤ 3 ppm arsenic (as As); ≤ 1 ppm mercury (as Hg); and ≥ 80% total color (FDA 1976).
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- other: Swiss-Millerton mice
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: American Cyanamid Company 1967- Age at study initiation: 6 weeks- Weight at study initiation: No data available- Fasting period before study: No data available- Housing: 10/cage- Diet (e.g. ad libitum): No data available- Water (e.g. ad libitum): No data available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- propylene glycol
- Details on exposure:
- DIET PREPARATION- Rate of preparation of diet (frequency): No data available- Mixing appropriate amounts with (Type of food): No data available- Storage temperature of food: No data availableVEHICLE- Justification for use and choice of vehicle (if other than water): No data available- Concentration in vehicle: 0, 1 or 2%(1428.5 or 2857.1 mg/Kg bw)- Amount of vehicle (if gavage): No data available- Lot/batch no. (if required): No data available- Purity: No data available
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Duration of treatment / exposure:
- 107 weeks
- Frequency of treatment:
- Daily
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 1 or 2% (1428.5 or 2857.1 mg/Kg bw)Basis:
- No. of animals per sex per dose:
- Total: 4001%: 1002%: 100Control: 200
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes- Time schedule: Daily- Cage side observations checked in table [No.?] were included. MortalityDETAILED CLINICAL OBSERVATIONS: No data available - Time schedule: No data availableDERMAL IRRITATION (if dermal study): No data available- Time schedule for examinations: No data availableBODY WEIGHT: Yes- Time schedule for examinations: 6 months intervalFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data available- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data availableFOOD 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 availableWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available- Time schedule for examinations: No data availableOPHTHALMOSCOPIC EXAMINATION: No data available - Time schedule for examinations: No data available- Dose groups that were examined: No data availableHAEMATOLOGY: No data available- Time schedule for collection of blood: No data available- Anaesthetic used for blood collection: No data available- Animals fasted: No data available- How many animals: No data available- Parameters checked in table [No.?] were examined. No data availableCLINICAL CHEMISTRY: No data available - Time schedule for collection of blood: No data available- Animals fasted: No data available- How many animals: No data available- Parameters checked in table [No.?] were examined. No data availableURINALYSIS: No data available- Time schedule for collection of urine: No data available- Metabolism cages used for collection of urine: No data available- Animals fasted: No data available- Parameters checked in table [No.?] were examined. No data availableNEUROBEHAVIOURAL EXAMINATION: No data available- Time schedule for examinations: No data available- Dose groups that were examined: No data available- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data availableOTHER: No data available
- Sacrifice and pathology:
- GROSS PATHOLOGY:Yes, The animals were necropsied over weeks 102 to 107 and neoplasms were observedHISTOPATHOLOGY: YesMicroscopic examination was performed on tissues of 10 animals of the test and control groups; animals with the “greatest array of grossly evident lesions” were chosen for microscopic examination. Neoplasms from other animals, with the exception of some “obvious leukemias,” were also examined microscopically.
- Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Details on Result:CLINICAL SIGNS AND MORTALITYMortality: Survival of test animals was similar to or slightly greater than that of controls.BODY WEIGHT AND WEIGHT GAIN No data availableFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study) No data availableFOOD EFFICIENCY No data availableWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study) No data availableOPHTHALMOSCOPIC EXAMINATION No data availableHAEMATOLOGY No data availableCLINICAL CHEMISTRY No data availableURINALYSIS No data availableNEUROBEHAVIOUR No data availableORGAN WEIGHTS No data availableGROSS PATHOLOGY No data availableHISTOPATHOLOGY: NON-NEOPLASTIC No data availableHISTOPATHOLOGY: NEOPLASTIC (if applicable) The probability of occurrences of neoplasms or of leukemia in the test mice was no different than, or significantly lower than, that of controls.HISTORICAL CONTROL DATA (if applicable) No data availableOTHER FINDINGS No data available
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 857.1 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Lesions observed were same in the treated and control group
- Remarks on result:
- other:
- Remarks:
- Effect type: other: Not carcinogenic (migrated information)
Applicant's summary and conclusion
- Conclusions:
- Ext. D & C Violet No. 2–induced gross or microscopic lesions were not observed and hence the carcinogenic No Observed Adverse Effect Level (NOAEL) for the test compound is 2% (2857.1 mg/Kg bw).
- Executive summary:
Carcinogenic potential of the test compound Acid Violet 43 was evaluated on mice in 107 weeks study period.
One hundred female Swiss-Millerton mice, grouped 10 per cage, received weekly dermal applications of Ext. D & C Violet No. 2 to a shaved scapular area of the back. A control group of 200 mice received weekly applications of vehicle.
For thefirst dose, 0.1 ml of a 1%aqueous solution of Ext. D & C Violet No. 2 was applied witha syringe; this method of dosing was unsatisfactory because thesolution did not wet the skin of the animals. Doses 2 through6 were applied with a “camel’s hair” brush as 2% dispersionsin propylene glycol, and doses 7 through 103 were applied as1% dispersions in propylene glycol. The applications were madeover a 107-week period. The test and control animals were killedwhen test group survival approached 30%of the original 100 animalsof the group. The animals were necropsied over weeks 102to 107. Observations were made daily for dead animals and, afterdosing, for presence of papillomas or other neoplasms. Bodyweights were determined at 6-month intervals. Microscopic examinationwas performed on tissues of 10 animals of the test
and control groups; animals with the “greatest array of grossly evident lesions” were chosen for microscopic examination. Neoplasms from other animals, with the exception of some “obvious leukemias,” were also examined microscopically.
It was estimated that the test animals received approximately 27 mg/kg of Ext. D & C Violet No. 2 each week. Survival of test animals was similar to or slightly greater than that of controls. The probability of occurrences of neoplasms or of leukemia in the test mice was no different than, or significantly lower than,that of controls.
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