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EC number: 605-104-5 | CAS number: 157577-99-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- disodium 4-amino-3-[2-(4-{4-[2-(2,4-diaminophenyl)diazen-1-yl]benzenesulfonamido}phenyl)diazen-1-yl]-5-hydroxy-6-(2-phenyldiazen-1-yl)naphthalene-2,7-disulfonate
- EC Number:
- 605-104-5
- Cas Number:
- 157577-99-6
- Molecular formula:
- C34H26N10Na2O9S3
- IUPAC Name:
- disodium 4-amino-3-[2-(4-{4-[2-(2,4-diaminophenyl)diazen-1-yl]benzenesulfonamido}phenyl)diazen-1-yl]-5-hydroxy-6-(2-phenyldiazen-1-yl)naphthalene-2,7-disulfonate
Constituent 1
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The test item was tested as suspension prepared from test item at 20% concentration in a 0.9% sodium chloride solution.
1g of the test item was suspended in 5 mL of 0.9% sodium chloride solution
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- The value of IVIS for the positive control (20% imidazole in 0.9% NaCl) obtained during the study was 73.28. This value is within the acceptance limit (one standard deviation of the current historical mean), so the study is considered acceptable.
The value of opacity for negative control (0.9% NaCl) obtained during the study was 1.89
and value of permeability was 0.050.
The values obtained during this study not exceeded upper limits, so the study is considered acceptable.
The basic values for the IVIS calculation (opacity values) could not be measured because of colouring of corneas which were applied by the test item.
Therefore the In Vitro Irritancy Score (IVIS) for test item, Acid Black 234, could not be calculated.
For this reason the classification was not performed
Any other information on results incl. tables
Group | Cornea No. | Appearance after exposure |
Negative control (0.9% NaCl) | 1 | Without macroscopic damage |
2 | Without macroscopic damage | |
4 | Without macroscopic damage | |
Positive control (20% Imidazole in 0.9% NaCl) | 4 | Corneal opacity |
5 | Corneal opacity | |
6 | Corneal opacity | |
Test item (Acid Black 234) | 10 | colouring by the test item – marked (black colour) |
11 | colouring by the test item – marked (black colour) | |
12 | colouring by the test item – marked (black colour) |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The basic values for the IVIS calculation (opacity values) could not be measured because of colouring of corneas which were applied by the test item.
Therefore the In Vitro Irritancy Score (IVIS) for test item, Acid Black 234, could not be calculated.
For this reason the classification was not performed - Executive summary:
The test item, Acid Black 234, was tested for the potential to cause ocular corrosivity or severe irritancy, as measured by its ability to induce opacity and increased permeability in an isolated bovine cornea. The test was performed according to OECD Test Guideline No. 437 (2017) and Method B.47 Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, Commission Regulation (EU) 2017/735, Adopted 14th February 2017.
The testing was performed on three groups of corneas: test item treatment group (20% in NaCl), positive control group (20% w/v imidazole in 0.9% NaCl solution) and negative control group (0.9% NaCl solution). Three corneas per group were used.
The closed-chamber method was used, because the test item solution was applicable by micropipette. The opacity and permeability of each cornea were measured. The In Vitro Irritancy Score (IVIS) was calculated from the values of opacity and permeability.
The opacity and permeability of each cornea were measured. The In Vitro Irritancy Score (IVIS) was calculated from the values of opacity and permeability.
The basic values for the IVIS calculation (opacity values) could not be measured because of colouring of corneas which were applied by the test item.
Therefore the In Vitro Irritancy Score (IVIS) for test item, Acid Black 234, could not be calculated.
For this reason the classification was not performed.
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