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Diss Factsheets
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EC number: 940-889-0 | CAS number: 1770781-13-9
- 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
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: The Bovine Corneal Opacity and Permeability (BCOP) Test Method, March 2006.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992.
- Principles of method if other than guideline:
- List of protocol deviations:
1. The isolated corneas were stored in a petri dish with cMEM at room temperature.
Evaluation: For technical reasons, during the examination phase of the eyes and the isolation of the corneas, these were stored at room temperature. The corneas mounted in the corneal holder were incubated for the minimum of 1 hour at 32 ± 1°C. This deviation had no effect on the results of the study.
2. The time, on which the incubation with sodium-fluorescein was ended, was not registered.
Evaluation: The incubation time should be 90 ± 5 minutes. The time of the next step, the permeability measurement was registered and was 110 minutes. Furthermore the values observed for the negative and positive control were within the historical control data ranges. Therefore, it can be concluded that the incubation with sodium-fluorescein was approximately 90 minutes and this deviation had no effect on the results of the study.
The study integrity was not adversely affected by the deviations. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(2-{(E)-2-[(1E)-1-{(2E)-2-[1,1-dimethyl-3-(4-sulfobutyl)-1,3-dihydro-2H-benzo[e]indol-2-ylidene]ethylidene}-2-{methyl[(trifluoromethyl)sulfonyl]amino}-1H-inden-3-yl]vinyl}-1,1-dimethyl-1H-benzo[e]indolium-3-yl)butane-1-sulfonate compound with N,N-diethylethanamine (1:1)
- EC Number:
- 940-889-0
- Cas Number:
- 1770781-13-9
- Molecular formula:
- C51 H52 F3 N3 O8 S3 . C6 H15 N
- IUPAC Name:
- 4-(2-{(E)-2-[(1E)-1-{(2E)-2-[1,1-dimethyl-3-(4-sulfobutyl)-1,3-dihydro-2H-benzo[e]indol-2-ylidene]ethylidene}-2-{methyl[(trifluoromethyl)sulfonyl]amino}-1H-inden-3-yl]vinyl}-1,1-dimethyl-1H-benzo[e]indolium-3-yl)butane-1-sulfonate compound with N,N-diethylethanamine (1:1)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- 97.85 % purity, green-brown powder, 0.87% water
Constituent 1
Test animals / tissue source
- Species:
- other: bovine eye after slaughter
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Bovine eyes were used as soon as possible after slaughter on the same day.
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- CH03938 was weighed in a bottle and applied directly on the corneas in such a way that the cornea was completely covered (308 to 319 mg).
- Duration of treatment / exposure:
- 240 +- 10 min
- Observation period (in vivo):
- /
- Number of animals or in vitro replicates:
- 3 eyes as negative control, 3 eyes as positive control and 3 eyes tested on CH03938
- Details on study design:
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Additionally the opacity and permeability values were evaluated independently to determine whether the test substance induced irritation through only one of the two endpoints.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: mean opacity
- Basis:
- mean
- Score:
- 29
- Reversibility:
- not specified
- Irritation parameter:
- other: permeability
- Basis:
- mean
- Score:
- 0.057
- Reversibility:
- not specified
- Irritation parameter:
- other: in vitro irritation score
- Basis:
- mean
- Score:
- 30
- Reversibility:
- not specified
Any other information on results incl. tables
Summary of opacity, permeability and in vitro scores
Treatment Mean Opacity Mean Permeability Mean In vitro Irritation Score 1, 2
Negative control 0 0.000 0.0
Positive control 104 1.315 124
CH03938 29 0.057 30
1 Calculated using the negative control mean opacity and mean permeability values.
2 In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Since CH03938 induced an IVIS > 3 ≤ 55.1, it is concluded that CH03938is mild to moderate irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
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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