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EC number: 223-912-2 | CAS number: 4118-16-5
- 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:
- other: in vitro turn key strategy
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 Oct 2014 - 02 Feb 2015
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (2014a) Draft Proposal for a New Test Guideline: Reconstructed Human Cornealike Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage
- Principles of method if other than guideline:
- The test is based on the experience that irritant chemicals produce cytotoxicity in human reconstructed cornea after a short term topical exposure. The test is designed to predict an eye irritation potential of a chemical by using the three dimensional human cornea model EpiOcularTM. After application of the test material to the surface of the EpiOcularTM 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.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,1'-[(6-phenyl-1,3,5-triazine-2,4-diyl)diimino]bisanthraquinone
- EC Number:
- 223-912-2
- EC Name:
- 1,1'-[(6-phenyl-1,3,5-triazine-2,4-diyl)diimino]bisanthraquinone
- Cas Number:
- 4118-16-5
- Molecular formula:
- C37H21N5O4
- IUPAC Name:
- 1,1'-[(6-phenyl-1,3,5-triazine-2,4-diyl)diimino]di(9,10-anthraquinone)
- Details on test material:
- - Physical state: Solid / yellow
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- other: reconstructed three dimensional human cornea model
- Strain:
- other: Tissue model: OCL-200
- Details on test animals or tissues and environmental conditions:
- The EpiOcular™ model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinocytes used to model the human corneal epithelium). The EpiOcularTM tissues (surface 0.6 cm²) are cultured on especially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and are commercially available as kits (EpiOcular™ 200), containing 24 tissues on shipping agarose.
Supplier: MatTek In Vitro Life Science Laboratories, Bratislava
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control (NC): De-ionized water, sterile Positive control (PC): Methyl acetate (98+%, CAS No.: 79-20-9)
- Amount / concentration applied:
- TEST MATERIAL
The test substance is applied undiluted; therefore no preparation of the test substance in a vehicle was performed. - Duration of treatment / exposure:
- After application, the tissues were placed into the incubator until the total exposure time of 6 hours was completed.
- Number of animals or in vitro replicates:
- Two tissues were treated with each, the test substance, the PC and the NC.
- Details on study design:
- PREINCUBATION OF THE TISSUES
On the day of arrival in the laboratory, the tissues were transferred to sterile 6-well plates with 1 mL assay medium and preconditioned in the incubator at 37°C. After 1 hour the preincubation medium was replaced with fresh medium and preconditioning continued in the incubator at standard culture conditions for 16 – 24 hours.
PRETREATMENT OF THE TISSUES
After the pre-incubation, the tissues were pre-treated with 20 μL of PBS in order to wet the tissue surface. The tissues were incubated at standard culture conditions for 30 minutes.
APPLICATION OF THE TEST SUBSTANCE
Using a sharp spoon, a bulk volume of 50 μL of the test material was applied covering the whole tissue surface.
Control tissues were concurrently applied with 50 μL of sterile de-ionized water (NC) or with 50 μL of methyl acetate (PC).
After application, the tissues were placed into the incubator until the total exposure time of 6 hours was completed.
REMOVAL OF TEST SUBSTANCE
To remove the test substance, the tissues were washed with sterile PBS. For this purpose the tissues were immersed and swiveled three times in each of three beakers filled with PBS. Washed tissues were immediately immersed into 12-well plates, pre-filled with 5 mL/well prewarmed
medium (post-soak immersion) in order to remove residual test substance. After 25 minutes (solids) of post-soak immersion, each tissue was dried on absorbent paper and transferred to fresh 6-well plates filled with 1 mL/well pre-warmed medium. Subsequently, the tissues were incubated at standard culture conditions for 18 hours (postincubation period).
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Tissue viability in %
- Remarks:
- average of 2 samples
- Run / experiment:
- #1
- Value:
- 104
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Other effects:
- The test substance is not able to reduce MTT directly.
Any other information on results incl. tables
RESULTS OF THE EPIOCULAR TEST
Test substance |
tissue 1 | tissue 2 | mean | inter-tissue variability [%] | |
NC | mean OD570 | 1.555 | 1.424 | 1.490 | |
viability [% of NC] | 104.4 | 95.6 | 100 | 8.8 | |
14/0579-1 | mean OD570 | 1.687 | 1.410 | 1.548 | |
viability [% of NC] | 113.2 | 94.7 | 104 | 18.6 | |
PC | mean OD570 | 0.400 | 0.363 | 0.382 | |
viability [% of NC] | 26.9 | 24.4 | 26 | 2.5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observed results for the EpiOcular Test it was concluded, that the test article does not show an eye irritation potential under the test conditions chosen.
- Executive summary:
The potential of the test article to cause ocular irritation was assessed by a single topical application of 50 μL bulk volume (about 20 mg) of the undiluted test substance to a reconstructed three dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissue samples were incubated with the test substance for 6 hours followed by a 18-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability. The EpiOcular™ eye irritation test showed the following results:
The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 104%.
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