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EC number: 612-411-8 | CAS number: 61813-75-0
- 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:
- 08/09/2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The acute oral toxicity study of Solvent blue-43 was conducted in wistar albino rats. The study was conducted under the OECD Guideline-423 for testing of chemicals following Good Laboratory Practice. The healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization to standard laboratory condition for period of one week.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- disodium 4-{[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium 3-{[ethyl({4-[(4-{ethyl[(3-sulfonatophenyl)methyl]amino}cyclohexa-2,5-dien-1-ylidene)(2-sulfonatophenyl)methyl]phenyl})amino]methyl}benzene-1-sulfonate
- Cas Number:
- 61813-75-0
- Molecular formula:
- C61H70N6S3O9
- IUPAC Name:
- disodium 4-{[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium 3-{[ethyl({4-[(4-{ethyl[(3-sulfonatophenyl)methyl]amino}cyclohexa-2,5-dien-1-ylidene)(2-sulfonatophenyl)methyl]phenyl})amino]methyl}benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report) : Solvent Blue 43
- Molecular formula (if other than submission substance): C61H70N6S3O9
- Molecular weight (if other than submission substance): 1136
- Substance type : solid
- Physical state : powder
- Analytical purity : 99.55
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Doses:
- The test was administered by oral route by using of oral cannula at the dose volume of 10 ml/kg b.wt.
- No. of animals per sex per dose:
- 3
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Starting dose 300 mg/kg body weight:
Step- I:
The test compound was dissolved in distilled water and administered orally at the dose level of 300 mg/kg body weight (dose volume 10ml/kg) to three female rats. Whereas, vehicle control group treated with the distilled water at the dose level of 10 ml/kg b.wt. The treated animals were closely observed for clinical signs of intoxication during first four hours of test compound administration. Thereafter, all the animals were observed periodically at one hour interval for 24 hrs and once daily for a period of 14 days. The necropsy was performed on all animals which died during the study or were sacrificed at termination of the study.
The test compound administered at the dose level of 300 mg/kg b.wt did not produce any mortality throughout the period of observation 14 days. Furthermore, test compound solvent blue-43 did not elicit any clinical signs of intoxication throughout the period of observation. No clinical signs were observed in vehicle control group.
The necropsy finding did not show any gross pathological changes in animal which was sacrifice during the end of experimentation.
Step -II:
After 72 hrs, the result of step-I was confirmed by administration of same dose level (300 mg/kg. b.wt) of test compound in additional three animals of same sex (OECD-423 guidelines).
The test compound administered at the dose level of 300 mg/kg b.wt did not produce any mortality throughout the period of observation 14 days. Furthermore, test compound solvent blue-43 did not elicit any clinical signs of intoxication throughout the period of observation. No clinical signs were observed in vehicle control group.
The necropsy finding did not show any gross pathological changes in animal which was sacrificed during the end of experimentation.
Final dose 2000 mg/kg body weight:
Step-I
The test compound was dissolved in distilled water and administered orally at the dose level of 2000 mg/kg body wt. (dose volume 10 ml/kg) to three female rats. All the animals were closely observed for clinical sign of toxicity and mortality gross pathological changes individually once in 30 minutes, 1, 2, 4 and 6 hrs intervals during the first 24 hrs and thereafter, once daily for a period of 14 days. The necropsy was performed on all animals which died during the study or were sacrificed at termination of the study.
The necropsy was performed on all animals which died during the study or were sacrificed at termination of the study.
The test compound administered at the dose level of 2000 mg/kg b.wt did not produce any mortality throughout the period of observation 14 days. Furthermore, test compound solvent blue-43 did not elicit any clinical signs of intoxication throughout the period of observation.
The necropsy finding did not show any gross pathological changes in animal which was sacrifice during the end of experimentation.
Step -II:
After 72 hrs, the result of step-I was confirmed by administration of same dose level (2000 mg/kg. b.wt) of test compound in additional three animals of same sex (OECD-423 guidelines).
The test compound administered at the dose level of 2000 mg/kg b.wt did not produce any mortality throughout the period of observation 14 days. Furthermore, test compound solvent blue-43 did not elicit any clinical signs of intoxication throughout the period of observation. No clinical signs were observed in vehicle control group.
The necropsy finding did not show any gross pathologicalApplicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It is concluded that the test compound Solvent blue-43 sponsored by Unique Chemicals & Allied Products following the guideline OECD-423 is acutely nontoxic to wistar albino rats.
- Executive summary:
Finally, it is concluded that the test compound Solvent blue-43 following the guideline OECD-423 is acutely nontoxic to wistar albino rats. According toGlobally Harmonized Classification System for Chemical Substances, it comes under the Globally Harmonized Classification (GHC) Category-5and LD50cutoff is 5000 mg/kg b.wt.
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