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Diss Factsheets
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EC number: 687-668-2 | CAS number: 815676-09-6
- 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
- Remarks:
- enucleated eye nucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed on 21 April 2010. Report issued: 24 August 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Rabbit Enucleated Eye Test (REET)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-({5-cyano-4-methyl-6-[(4-sulfophenyl)amino]pyridin-2-yl}amino)benzene-1-sulfonic acid
- EC Number:
- 687-668-2
- Cas Number:
- 815676-09-6
- Molecular formula:
- C19H16NO6S2
- IUPAC Name:
- 4-({5-cyano-4-methyl-6-[(4-sulfophenyl)amino]pyridin-2-yl}amino)benzene-1-sulfonic acid
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Tetrahydrothiophene 1,1-dioxide
- EC Number:
- 204-783-1
- EC Name:
- Tetrahydrothiophene 1,1-dioxide
- Cas Number:
- 126-33-0
- Molecular formula:
- C4H8O2S
- IUPAC Name:
- Sulfolane
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
impurity 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A volume of 0.1 ml of the test substance was applied, which was found to weigh approximately 85 mg (as measured following gently compacting the required volume into an adapted syringe).
- Duration of treatment / exposure:
- The test material was sprinkled as evenly as possible over the surface of the cornea. After 10 seconds the test material was washed off the cornea using a minimum of 20 ml of saline solution at approximatley 32°C. Untreated eye were similarly washed and used for control purposes.
- Number of animals or in vitro replicates:
- A total of five eye were used on the study. Three eyes treated with test substance and two eyes remained untreated for control purposes.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (cloudiness x area)
- Value:
- ca. 3
- Negative controls validity:
- valid
- Irritation parameter:
- other: fluorescein uptake
- Remarks:
- (Intensity of fluorescein uptake x area)
- Value:
- ca. 3
- Negative controls validity:
- valid
- Irritation parameter:
- other: condition of corneal epithelium
- Negative controls validity:
- valid
- Remarks on result:
- other: pitting
- Remarks:
- meets or exceeds cut-off value indicating a severe ocular irritant.
- Irritation parameter:
- other: % corneal swelling of test eyes at 60 minutes
- Value:
- 10.2
- Negative controls validity:
- valid
- Irritation parameter:
- other: % corneal swelling of test eyes at 120 minutes
- Value:
- ca. 15.3
- Negative controls validity:
- valid
- Irritation parameter:
- other: % corneal swelling of test eyes at 240 minutes
- Value:
- ca. 20.5
- Negative controls validity:
- valid
- Irritation parameter:
- other: % corneal swelling of control eyes at 60 minutes
- Value:
- ca. 5.7
- Irritation parameter:
- other: % corneal swelling of control eyes at 120 minutes
- Value:
- ca. 4.6
- Irritation parameter:
- other: % corneal swelling of control eyes at 240 minutes
- Value:
- ca. 3.6
- Other effects / acceptance of results:
- Corneal Opacity
Some loss of transparency was noted in all test eyes. No corneal effects were noted in the control eyes during the study.
Corneal thickness and Condition
Corneal swelling of the test eyes was slightly greater than that observed in the control eyes over the same period. The condition of the corneal epithelium of the test eyes appeared normal 60 minutes after dosing but pitting was noted 120, 180 and 240 minutes after dosing. The condition of the corneal epithelium of the control eyes appeared normal during the study.
Fluorescein Uptake
Slight fluorescein staining was noted in the test eyes 240 minutes following test material application. No fluorescein uptake was noted in the control eyes 240 minutes following treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Following assessment of the data for all endpoints, the test material was considered to have the potential to cause severe ocular irritancy in vivo. The in vivo eye irritation study is therefore not required.
- Executive summary:
Introduction
The potential of the test substance to cause eye irritation/damage was assessed using the Rabbit Enucleated Eye Test (REET) due to the low pH of the test material, prior to possible in vivo testing. This step-wise procedure is in accordance with OECD Test Guideline 405 and UK Home Office Regulations.
Method
0.1 ml of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32°C ± 1.5°C within a superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).
Results and Conclusion
Following assessment of the data for all endpoints the test material was considered to have the potential to cause severe ocular irritancy in vivo. The in vivo eye irritation study is therefore not required.
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