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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 November 2014 to 03 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines; coherence between data, results and conclusion.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD series on testing and assesment no. 160
- Qualifier:
- according to guideline
- Guideline:
- other: Use of an alternate testing framework for classification of eye irritation potential of EPA pesticide products - Office of Pesticide Programs, U.S. Environmental Protection Agency (31 May 2013)
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item: Disperse Blue CVG
Constituent 1
Test animals / tissue source
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Test system: isolated corneas from the eyes of freshly slaughtered bovine.
Age of animals: 6-12 months
Transport solution: Hanks balanced salt solution (HBSS) Modified supplemented with Penicillin sulphate and Streptomycin sulphate.
Transport conditions: in transport solution at approximately 4°C.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- The test item was spread on each epithelial surface of three idoneous bovine corneas as supplied (150 mg/cornea); 0.75 mL of physiological saline was then added on each cornea in order to better distribute the substance on the cornea surface (final concentration on cornea = 200 mg/mL, approximately 20% w/v)
Number of replicates: 3 - Duration of treatment / exposure:
- Corneas were exposed in horizontal position for 4 hours ± 10 minutes, incubated in a liquid bath at 32 ± 1°C.
There was no post-exposure period. - Observation period (in vivo):
- exposure period: 4 hours --> determination of opacity
fluorescein staining: 90 minutes --> corneal permeability - Number of animals or in vitro replicates:
- three idoneous bovine corneas
- Details on study design:
- Positive control item: corneas treated 20% (w/v) Imidazole (Sigma, batch no. 0001422794) in Physiological saline (0.9% NaCl) (Baxter, batch no. 13D0406).
Negative control item: corneas treated with Physiological saline (0.9% NaCl) (Baxter, batch no. 13D0406).
Volume of treatment: 0.75 mL
Number of replicates: 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: mean opacity score
- Basis:
- mean
- Time point:
- other: at the end of the test item exposure period
- Score:
- 4
- Remarks on result:
- other: 4 h exposure time
- Irritation parameter:
- other: mean permeability OD490 score
- Basis:
- mean
- Time point:
- other: 90 min
- Score:
- 0
- Remarks on result:
- other: staining with a 0.5% solution of sodium fluorescein in DPBS for 90 minutes
- Irritation parameter:
- other: In vitro irritancy score (IVIS)
- Basis:
- mean
- Time point:
- other: 4 h exposure + 90 min staining
- Score:
- 4
- Max. score:
- 55
- Remarks on result:
- other: In vitro irritancy score (IVIS) = mean opacity score + (15 x mean permeability OD490 score)
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The test item Disperse Blue CVG cannot be clearly classified.
- Executive summary:
The potential of the test item, Disperse Blue CVG, to cause corrosion/severe irritation by using the Bovine Corneal Opacity and Permeability (BCOP) assay, was examined in agreement with OECD Guideline no. 437 (adopted on 26 July 2013), the Guidance Document OECD series on testing and assessment no. 160 and the method described in the document issued by U.S. EPA/OPP (31 May 2013). The test item was spread on each epithelial surface of three idoneous bovine corneas as supplied (150 mg/cornea); 0.75 mL of physiological saline was then added on each cornea in order to better distribute the substance on the cornea surface (final concentration on cornea = 200 mg/mL, approximately 20% w/v); an exposure period of 4 hours was used. The mean opacity detected with an opacitometer at the end of the test item exposure period was 4.0. At macroscopic observation, no visible change of the treated corneas was noted. After the determination of opacity, the epithelial surface was treated with a 0.5% solution of sodium fluorescein in DPBS for 90 minutes, to investigate alteration in cornea permeability. The calculated mean permeability OD490 value of the corneas treated with the test item was 0.00. The calculated in vitro irritancy score (IVIS) for the test item was 4.0. Positive and negative controls [a 20 % (w/v) Imidazole solution in physiological saline and physiological saline alone, respectively] were concurrently tested in similar conditions and gave the expected results. According to the OECD Guideline no. 437, the test item cannot be clearly classified.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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