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EC number: 278-601-4 | CAS number: 77061-58-6
- 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:
- Reported 17Apr2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- 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 i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (2014a) Draft Proposal for a New Test Guideline (EpiOcular™)
- Version / remarks:
- (2014a) Draft Proposal
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- EC Number:
- 278-601-4
- EC Name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Cas Number:
- 77061-58-6
- Molecular formula:
- C13H18N5.Cl
- IUPAC Name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test Substance name: Vibracolor ruby red
Test Substance: 10/0383-3
Batch: 0009051093
CAS: 77061-58-6
Test animals / tissue source
- Species:
- other: Two test systems utilised: 1) Isolated corneas from the eyes of freshly slaughtered cattle 2) human reconstructed cornea after a short term topical exposure
- Details on test animals or tissues and environmental conditions:
- Two test systems utilised:
1) Isolated corneas from the eyes of freshly slaughtered cattle
2) human reconstructed cornea after a short term topical exposure
Test system
- Vehicle:
- other: Both diluted in de-ionized water and undiluted (unchanged; no vehicle)
- Amount / concentration applied:
- BCOP: Three corneas were treated with 750 μL of 50% and 5% test-substance preparations in deionized water for 10 minutes followed by a 2-hours post-incubation period.
EpiOcular: Two EpiOcular™ tissue samples were incubated with each, 50 μL bulk volume (about 14 mg) of the undiluted test substance or 50 μL of a 5% test-substance preparation for 6 hours followed by an 18-hours post-incubation period. - Duration of treatment / exposure:
- BCOP: 10 minutes followed by a 2-hours post-incubation period.
EpiOcular: 6 hours followed by an 18-hours post-incubation period. - Duration of post- treatment incubation (in vitro):
- BCOP: 2-hours post-incubation period.
EpiOcular: 18-hours post-incubation period. - Number of animals or in vitro replicates:
- BCOP: Three corneas
EpiOcular: Two EpiOcular™ tissue samples - Details on study design:
- BCOP: Three corneas were treated with 750 μL of 50% and 5% test-substance preparations in deionized water for 10 minutes followed by a 2-hours post-incubation period.
EpiOcular: Two EpiOcular™ tissue samples were incubated with each, 50 μL bulk volume (about 14 mg) of the undiluted test substance or 50 μL of a 5% test-substance preparation for 6 hours followed by an 18-hours post-incubation period.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- BCOP TEST with test item at 5% in de-ionised water
- Value:
- 1.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Potential for irritation - refer to EIPOCULAR test
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- BCOP TEST with test item at 50% in de-ionised water
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Potential for irritation - refer to EIPOCULAR test
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- BCOP TEST with test item at 5% in de-ionised water
- Value:
- 1.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Potential for irritation - refer to EIPOCULAR test
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- BCOP TEST with test item at 50% in de-ionised water
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Potential for irritation - refer to EIPOCULAR test
- Irritation parameter:
- other: viability values
- Run / experiment:
- EPIOCULAR TEST - Undiluted test substance
- Value:
- 2.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: viabilty values
- Run / experiment:
- EPIOCULAR TEST - 5% test-substance de-ionised in urified water
- Value:
- 4.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Applying the criteria of the OECD 437 fortheassessment of the BCOP test results,theIVISscores ofthe testsubstance of 0.0 (50%testsubstance preparation) or 1.9 (5% test substance preparation) would classify it as a substance that does not cause eye irritation or serious eye damage.However,the Guideline also states,that due to limited accuracy of the BCOP test to correctlyidentifysubstances that do not require classification for eyeirritationor serious eye damage,thistestmethodshould not bethe firstchoice toinitiatea bottom-up approach. Based onthisstatement and the experience ofthe testfacility,testsubstances leading to IVIS <3 are generally examinedin the EpiOculartest as well.In thecurrent case, the EpiOculartestwas positive and thetestsubstance was assessedtobe irritating.
Based on the results forBCOPandEpiOcular Testand applying the evaluation criteria describedinsection 3,Vibracolor ruby red showsaneye irritation potentialinthein vitroeye irritation test strategy underthe testconditions chosen.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the results for BCOP and EpiOcular Test and applying the evaluation criteria described in section 3, Vibracolor ruby red shows an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen .
- Executive summary:
Based on the results for BCOP and EpiOcular Test and applying the evaluation criteria described in section 3,Vibracolor ruby red shows an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
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