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EC number: 306-764-4 | CAS number: 97404-02-9
- 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
- Study period:
- 22Apr2015
- 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)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (2014a) Draft Proposal for a New Test Guideline (EpiOcular™)
- Version / remarks:
- OECD (2014a) Draft
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride
- EC Number:
- 306-764-4
- EC Name:
- 2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride
- Cas Number:
- 97404-02-9
- Molecular formula:
- C11H14N5.Cl
- IUPAC Name:
- 2-[(1E)-2-(4-aminophenyl)diazen-1-yl]-1,3-dimethyl-2,3-dihydro-1H-imidazol-1-ium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- See individual study reports for purity information and CofA where applicable
Constituent 1
- Specific details on test material used for the study:
- Test substance No.: 14/0424-1
Batch identification: 0008205061
CAS No.: 97404-02-9
Physical state / color: Solid I red
Test animals / tissue source
- Species:
- other: Both Cattle (BCOP) and human cornea model (Epiücular) were tsted in this study
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- BCOP: isolated corneas from the eyes of freshly slaughtered cattle
Human: three dimensional human cornea model Epiocular™
Test system
- Vehicle:
- other: Undiluted, 5%, and 50% (w/v) suspension in de-ionized water
- Controls:
- other: BCOP: Historical Positive and Negative Control. EpiOcular: Historical Positive, Negative Control and Viability, concurrent Kllled Control for MTT-reduction, Killed Control for Color Control
- Amount / concentration applied:
- BCOP: 750 μL of 50% and 5% test-substance preparations in deionized water
Epiocular: 50 μL bulk volume (about 12 mg) of the undiluted test substance or 50 μL of a 5% test-substance - Duration of treatment / exposure:
- BCOP: 10 minutes
Epiocular: 6 hours - 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
Epiocular: Two - Details on study design:
- BCOP:
Washing performed after 10 mins, fluid not stated.
After determination of opacity and permeability, the corneas were fixed in 4% formaldehyde for at least 24 h and transferred to the laboratory of General Pathology for further histotechnical processing and examination by light microscopy.
Histopathological findings were summarized in a histopathological score of irritation (HSI) as follows:
0 = no findings
I = minimal
II = mild
III = moderate
IV= severe
Epiocular:
Washing performed after 6 hours, fluid not stated.
After application of the test material to the surface of the Epiocular™ tissue the induced cytotoxicity (= loss of viability) is measured by a colorimetric assay. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow colored water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5- diphenyltetrazolium bromide (MTT) to the insoluble blue colored formazan. After isopropanol extraction of the formazan from the tissues, the optical density of the extract is determined spectrophotometrically. Optical density of the extracts of test-substance treated tissues is compared to values from negative control tissues and expressed as relative tissue viability.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- BCOP, 50% test substance
- Value:
- 1
- Vehicle controls validity:
- valid
- Remarks:
- vehicle control was negative control (water)
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- BCOP, 5% test substance
- Value:
- 1.5
- Vehicle controls validity:
- valid
- Remarks:
- vehicle control was negative control (water)
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Mean Viability
- Run / experiment:
- Epiocular, Undiluted test substance
- Value:
- 13.7
- Vehicle controls validity:
- valid
- Remarks:
- vehicle control was negative control (water)
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Mean Viability
- Run / experiment:
- Epiocular, 5% test substance
- Value:
- 44.5
- Vehicle controls validity:
- valid
- Remarks:
- vehicle control was negative control (water)
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Applying the criteria of the OECD 437 for the assessment of the BCOP test results, the IVIS scores of the test substance of 1.0 (50% test substance preparation) or 1.5 (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 correctly identify substances that do not require classification for eye irritation or serious eye damage, this test method should not be the first choice to initiate a bottom-up approach. Based on this statement and the experience of the test facility, test substances leading to IVIS <3 are generally examined in the EpiOcular test as well. In the current case, the EpiOcular test was positive and the test substance was assessed to be irritating.
Based on the results for BCOP and EpiOcular Test and applying the evaluation criteria described in section 3, the test item shows an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen . - Executive summary:
Applying the criteria of the OECD 437 for the assessment of the BCOP test results, the IVIS scores of the test substance of 1.0 (50% test substance preparation) or 1.5 (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 correctly identify substances that do not require classification for eye irritation or serious eye damage, this test method should not be the first choice to initiate a bottom-up approach. Based on this statement and the experience of the test facility, test substances leading to IVIS<3 are generally examined in the EpiOcular test as well. In the current case, the EpiOcular test was positive and the test substance was assessed to be irritating.
Based on the results for BCOP and EpiOcular Test and applying the evaluation criteria described in section 3,the test item shows an eye irritation potential in thein vitro eye irritation test strategy under the test conditions chosen.
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