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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- May 1965
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- The test substance was used in formulation at low concentration (0.119 and 1.190%) instead of pure recommended by REAch regulation. No information about chemical substance analysis was provided (as batch, purity, stability). Only 10 animals per dose group were used instead of 20 required in Standard method (OECD Guideline 411 method)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Version / remarks:
- The test substance was used in formulation at low concentration (0.119 and 1.190%) instead of pure recommended by REAch regulation. No information about chemical substance analysis was provided (as batch, purity, stability). Only 10 animals per dose group were used instead of 20 required in Standard method (OECD Guideline 411 method)
- Principles of method if other than guideline:
- USP Hydropholic ointment, alone or containing 0.1 or 1% of External D&C Violet No. 2, was applied to shaved intact skin of male albino rabbit (5 animal per dose test group and 10 in control group). Doses were applied daily, 5 days per week, for a total of 65 applications over 91 days interval. Each dose of 0.5g of the appropriate mixture. All animals were observed for signs of skin irritation or systemic toxicity prior to each daily application of the ointment.
- GLP compliance:
- no
- Limit test:
- no
Test material
- 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
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Supplied by John H. Breck, Inc, no more details
- Expiration date of the lot/batch: no information
- Purity test date: Not less than 80%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In tubes, no more details
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was used in two formulations containing 0.119% and 1.190% of test item.
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: local supplier, no more details
- Females (if applicable) nulliparous and non-pregnant: not applicable
- Age at study initiation: not specified
- Weight at study initiation: 2.8 to 3.61 kg
- Fasting period before study: no information
- Housing:Animals were housed individually, no more details
- Diet (e.g. ad libitum): Standard laboratory diet (Hales and Hunter PIONEER rabbit pellets Medicated) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: period of 1-2 weeks
DETAILS OF FOOD AND WATER QUALITY:no information
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22.2 deg Celsius
- Humidity (%): 40-60%
- Air changes (per hr): air conditionned room, no more details
- Photoperiod (hrs dark / hrs light): 9 hours of light and 15 hours of dark on weekdays, 3 hours of light and 21 hours of dark on weekends
IN-LIFE DATES: From: To: No information
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: Test item in formulation containing : purified water (35%), white petrolatum (25%), stearyl alcohol (25%), Propylene glycol (12%), sodium lauryl sulfate (1%), propylparaben (0.015%), methylparaben (0.025%)
- Details on exposure:
- TEST SITE
- Area of exposure: no information
- % coverage: no information
- Type of wrap if used: no wrap used
- Time intervals for shavings or clipplings: the fur was clipped as necessary from time to time during the test period to insure intimate contact of the ointment with the bare skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no information
- Time after start of exposure: no information
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g per animal per day
- Concentration (if solution): 0.119% or 1.190% in formulation
- Constant volume or concentration used: yes constant volume used 0.5g
- For solids, paste formed: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): in formulation USP Hydrophilic Ointment
- Amount(s) applied (volume or weight with unit): 0.5g of appropriate ointment
- Concentration (if solution): not applicable
- Lot/batch no. (if required): No information
- Purity: no information
USE OF RESTRAINERS FOR PREVENTING INGESTION: No - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 91 Days
- Frequency of treatment:
- Daily, 5 days per weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.119 other: % in formulation
- Dose / conc.:
- 1.19 other: % in formulation
- No. of animals per sex per dose:
- 5 males per dose group and 10 animals in control group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: no information
- Rationale for animal assignment (if not random): not specified
- Rationale for selecting satellite groups: no satellite group
Examinations
- Observations and examinations performed and frequency:
- Animal were weighed initially, at weekly intervals thereafter, and on the day prior to sacrifice. The general physical condition of each animal was noted and recorded daily at the same time that the skin was observed for irritation
- Sacrifice and pathology:
- Liver and kidney weights were recorded at autopsy for all animals receiving applications of the dye and for 5 control rabbits. No other organs were weighed.
Complete autopsies were performed in treated animals and 5 control animals. Portions of liver, kidney and skin from the treated area were fixed in buffered neutral formalin, sectioned, stained with hematoxylin and eosin and examined microscopally. The tissues were examined from all animals receiving doses of the ointment containing 1% of the dye and from 5 control animals.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Animals showed signs of nasal and ocular discharges.
- Dermal irritation:
- not examined
- Description (incidence and severity):
- Skin of control animal appeared slighty pink while skin of treated animals assumed violet coloration. No skin or edema were evident.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- The mean liver weight was significantly lower than control but the absolute organ weights between test and control showed no difference.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 0.119 other: % in formulation
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- dermal irritation
- gross pathology
- organ weights and organ / body weight ratios
Applicant's summary and conclusion
- Conclusions:
- Under experimental conditions of this study, the registered item External D&C Violet No. 2 showed no adverse effect at 0.119% and 1.190% in formulation. Hence the No Observe Effect Level could be defined as 0.119%.However, this study cannot be used for classification because The test substance was used in formulation at low concentration (0.119 and 1.190%) instead of pure recommended by REACh regulation. No information about chemical substance analysis was provided (as batch, purity, stability). Only 5 animals per dose group were used instead of 20 required in Standard method (OECD Guideline 411 method). The dosing procedure was performed daily only 5 days per week instead of 7 days per week.
- Executive summary:
This no-GLP compliant study was performed to assess the potential toxic effect of the test item External D&C Violet no. 2 on albino rabbits dermally exposed during thirteen weeks.
USP Hydropholic ointment, alone or containing 0.1 or 1% of External D&C Violet No. 2, was applied to shaved intact skin of male albino rabbit (5 animal per dose test group and 10 in control group). Doses were applied daily, 5 days per week, for a total of 65 applications over 91 days interval. Each dose of 0.5g of the appropriate mixture. All animals were observed for signs of skin irritation or systemic toxicity prior to each daily application of the ointment.
Under experimental conditions of this study, the registered item External D&C Violet No. 2 showed no adverse effect at 0.119% and 1.190% in formulation. Hence the No Observe Effect Level could be defined as 0.119%.However, this study cannot be used for classification because The test substance was used in formulation at low concentration (0.119 and 1.190%) instead of pure recommended by REACh regulation. No information about chemical substance analysis was provided (as batch, purity, stability). Only 5 animals per dose group were used instead of 20 required in Standard method (OECD Guideline 411 method). The dosing procedure was performed daily only 5 days per week instead of 7 days per week.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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