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Diss Factsheets
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EC number: 263-606-6 | CAS number: 62570-50-7
- 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)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- 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:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-amino-4-(ethylamino)-9,10-dihydro-9,10-dioxoanthracene-2-carbonitrile
- EC Number:
- 263-606-6
- EC Name:
- 1-amino-4-(ethylamino)-9,10-dihydro-9,10-dioxoanthracene-2-carbonitrile
- Cas Number:
- 62570-50-7
- Molecular formula:
- C16H14N2O2
- IUPAC Name:
- 1-amino-4-(ethylamino)-9,10-dioxo-9,10-dihydroanthracene-2-carbonitrile
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch 135214 of Disperse Blue 359 was a dark blue powder with a purity of 99 %
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, -‘s Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Eyes were collected and transported in a physiological saline in a suitable container under cooled conditions.The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from physiological saline and holding them in the light. Those exhibiting defects were discarded.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 318-391 mg of Disperse Blue 359
- Duration of treatment / exposure:
- Corneas were first incubated in cMEM for a minimum of 1 hour at 32 ± 1 °C, the corneas were then incubated with the tests material in a horizontal position for 240 ± 10 minutes at 32 ± 1 °C.
- Number of animals or in vitro replicates:
- 9 samples in total, 3 replicates each for Disperse Blue 359, the positive control and the negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- >= -0.7
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Remarks:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.
- Positive controls validity:
- valid
- Remarks:
- The mean in vitro irritancy score of the positive control was 159 and within two standard deviations of the current historical positive control mean. It was therefore concluded that test conditions were adequate and that test system functioned properly.
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The individual in vitro irritancy scores for the negative controls ranged from -0.8 to -0.9. The individual positive control in vitro irritancy scores ranged from 140-187. The corneas treated with the positive control were turbid after the 240 minutes of treatment.
The corneas treated with Disperse Blue 359 showed opacity values ranging from -1.2 to -0.4 and permeability values ranging from 0 to 0.0037. The corneas were clear were clear after the 240 minutes of treatment with Disperse Blue 359. No pH effect of the test item was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -1.2 to 0.2 after 240 minutes of treatment with Disperse Blue 359.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 159 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Disperse Blue 359 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.7 after 240 minutes of treatment. Since Disperse Blue 359 induced an IVIS ≤3, no classification is required for eye irritation or serious eye damage.
- Executive summary:
Study describes the potency of chemicals to induce serious eye damage using isolated bovine corneas. The eye damage of Disperse Blue 359 was tested through the topical application for approximately 240 minutes. Procedures were based on the most recent OECD guideline. Since no workable suspension of test material in physiological saline solution could be obtained, the test item was used as delivered and added pure on top of the corneas.
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 159 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Disperse Blue 359 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.7 after 240 minutes of treatment. Since Disperse Blue 359 induced an IVIS ≤3, no classification is required for eye irritation or serious eye damage.
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