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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 March 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- No detail about test item was provided as purity, stability and solubility in vehicle. GLP-Compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Dated 12 May 1981
- Deviations:
- yes
- Remarks:
- No details on test item chemical analysis
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 79/831 de la C.E.E. -annexe V partie B-
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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
- Remarks:
- dark blue
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2.4.4908
- Expiration date of the lot/batch: no information
- Purity test date: no information
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
No information
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: in solution at 25% in dionized water
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- OFA strain (IOPS)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffra Credo (France)
- Females (if applicable) nulliparous and non-pregnant: Not specified
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: male : 160 to 220g / female : 140 to 180
- Fasting period before study: 17 to 18 hours prior to dosing
- Housing:in group of two or five animals per plastic cage (37.5 x 23.5 x 16.0 cm) with sterilized sawdust litter
- Diet (e.g. ad libitum): Diet including "Souriffarat entretien" food, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: no information
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1.5 deg celsius
- Humidity (%): 55±15% relative humidity
- Air changes (per hr): 10 per hours
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% in solution in vehicle
- Amount of vehicle (if gavage): 75%
- Justification for choice of vehicle:no justification
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg - Doses:
- Preliminary study : dose applied : 1000, 2000, 5000 mg/kg
- No. of animals per sex per dose:
- In preliminary study, 2 animals were used per sex per group
In main study, 5 animals per dose per group were used - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 1, 2, 4 hours and thereafter daily until the 14 day period of observation
They were weighed the day before the treatment, the day of treatment, at day 7 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,
Results and discussion
- Preliminary study:
- After treatment, at each dose level, no mortality occured for both group and animals.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occured during experimental procedure.
- Clinical signs:
- other: slight piloerection with slight despondency the two first hours after treatment
- Gross pathology:
- no anomaly was observed
Any other information on results incl. tables
Table 1 : Summary of the results |
||||||||||||||
Administration |
|
|
Animals |
|
Mortality |
|
|
|
|
|
|
|
|
|
Preliminary study |
Dose (mg/kg) |
Volume (ml/kg) |
Concentration (g/100ml) |
Weight(g) |
Number |
1hours |
2hours |
4hours |
Day 1 |
Day 2 |
Day 4 |
Day 7 |
Day 14 |
Total (%) |
1000 |
4 |
25 |
Male 203 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
Female163 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2000 |
10 |
25 |
Male 206 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
Female166 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
5000 |
20 |
25 |
Male 201 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
Female160 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Main Study |
0 |
/ |
0 |
Male 155 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Female149 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
5000 |
20 |
25 |
Male 156 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
Female148 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental condition of this study, the registered substance induced no mortality at each dose level. The Lethal Dose 50 value was defined as greater than 5000 mg/kg bw on rats by oral gavage. The registered substance is not classified as Acute Oral Hazard.
- Executive summary:
The GLP-compliant study aims the potential acute toxicity of the test item Acid Violet 43 on Sprague Dawley rats by oral routes (gavage). This study followed Standard Guideline 401 (dated 12 May 1981) and did not provided details test item (no analysis was performed: purity, stability, solubility were not reported).
The registered substance was administered orally on male and female rats (2 for preliminary study and 5 for the main study per sex) per dose group (gavage) at 1000, 2000 and 5000 mg/kg bw in preliminary study and 0 and 5000 mg/kg bw were used for the main study (limit test). The Acid Violet 43 was in suspension in deionized water.
Under the experimental condition of this study, the registered substance induced no mortality at each dose level. The Lethal Dose 50 value was defined as greater than 5000 mg/kg bw on rats by oral gavage. The registered substance is not classified as Acute Oral Hazard according CLP regulation.
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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