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EC number: 947-435-0 | CAS number: -
- 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:
- guideline study
- Remarks:
- according to OECD and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate)
- EC Number:
- 278-207-2
- EC Name:
- Aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate)
- Cas Number:
- 75431-69-5
- Molecular formula:
- C20H12N2O5S.1/3Al
- IUPAC Name:
- aluminum tris(7,14-dioxo-5,7,12,14-tetrahydroquino[2,3-b]acridine-2-sulfonate)
- Reference substance name:
- 5,12-dihydroquino[2,3-b]acridine-7,14-dione
- EC Number:
- 213-879-2
- EC Name:
- 5,12-dihydroquino[2,3-b]acridine-7,14-dione
- Cas Number:
- 1047-16-1
- Molecular formula:
- C20H12N2O2
- IUPAC Name:
- 5,12-dihydroquino[2,3-b]acridine-7,14-dione
- Reference substance name:
- Dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
- EC Number:
- 243-319-2
- EC Name:
- Dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
- Cas Number:
- 19795-24-5
- Molecular formula:
- C20H12N2O8S2.2/3Al
- IUPAC Name:
- dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- other: human cornea model
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 µL bulk volume (~ 25 mg)
- Duration of treatment / exposure:
- 6 hours followed by a 18 hours post-incubation period.
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- The EpiOcularTM 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 cell culture inserts (MILLICELLsR, diameter 10 mm) and are commercially available as kits (EpiOcularTM 200), containing 24 tissues on shipping agarose.
Tissue model: OCL-200
Lot number: 23747
Supplier: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
The test is based on the experience that irritant chemicals produce cytotoxicity in human reconstructed cornea after short 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 tissue the induced cytotoxicity (= loss of viability) is measured in a colometric 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 densitiy of the extract is determined spectrophotometrically. Optical density of the extracts of test-substance treated tissues is compared to values from negative control (NC) tissues and expressed as relative tissue viability.
On the day of arrival 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 pre-incubation medium was replaced with fresh medium and preconditioning continued at standard culture conditions for 16 - 24 hours.
After pre-incubation the tissues were pre-treated with 20 µL DPBS in order to wet the tissue surface. The tissues were incubated at standard culture conditions for 30 minutes.
Two tissues were treated with the test substance, the positive and negative control respectively. In addition two killed tissues were used for the test substance and the negative control respectively in order to detect direct MTT reduction.
A bulk volume of 50 µL of the test substance was applied covering the whole tissue surface.
Control tissues were concurrently applied with 50 µL of sterile de-ionized water (NC, NC KC) or with 50 µL of methyl acetate (PC) or test substance (KC). Then, the tissues were placed into the incubator until the total exposure time of 6 hours was completed.
The tissues were washed with sterile DPBS to remove residual test material. For this purpose the tissues were immersed and swiveled three times in aeach of three beakers filled with DPBS.
Rinsed tissues were immediately immersed into new 12-well plates, pre-filled with 5 mL well pre-warmed medium (post-soak immersion) in order to remove residual test substance. After 25 minutes 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 post-incubation period. After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated for 3 hours. Thereafter the tissues were washed with DPBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol at room temperature overnight for at least 2 hours on a plate shaker.
The optical densitiy at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 4 microtiter wells filled with isopropanol fro each microtiter plate.
The OD570 values determined for the various tissues are measures of their viability. The quotient of the OD570 of tissues treated with the test substance and the mean OD570 values of the NC is used for evaluating whether a test substance is irritant or not irritant.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % tissue viability
- Run / experiment:
- mean viability of tissues after KC correction
- Value:
- 96.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Findings:
substance |
|
|
tissue 1 |
tissue 2 |
mean |
Inter-tissue variability [%] |
negative control |
viable tissues |
mean OD570 |
1.506 |
1.469 |
1.487 |
|
viability [% of NC] |
101.2 |
98.8 |
100.0 |
2.5 |
||
KC tissues |
mean OD570 |
0.033 |
0.025 |
0.029 |
|
|
viability [% of NC] |
2.2 |
1.7 |
2.0 |
0.5 |
||
positive control |
viable tissues |
mean OD570 |
0.152 |
0.209 |
0.181 |
|
viability [% of NC] |
10.2 |
14.1 |
12.2 |
3.8 |
||
test substance |
viable tissues |
mean OD570 |
1.410 |
1.478 |
1.444 |
|
viability [% of NC] |
94.8 |
99.4 |
97.1 |
4.6 |
||
KC tissues |
mean OD570 KC NC corrected |
0.007 |
0.002 |
0.004 |
|
|
viability [% of NC] |
0.2 |
0.4 |
0.3 |
45.1 |
||
final mean viability of tissues after KC correction [% of NC] |
96.8 |
|
Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in parallel. The results of the KC tissues indicate an increased MTT reduction (mean viability 0.3 % NC). thus for the test substance the final mean viability is given after KC correction.
The data show, that a treatment with the test item did not significantly affect the viability of tissues (relative viabilty = 96.8 %)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) 1272/2008
- Conclusions:
- The test substance did not show an eye irritation potential in the EpiOcularTM in vitro eye irritation test. Therefore the substance has not to be classified according to Regulation (EC) 1272/2008.
- Executive summary:
The potential of the test substance to cause ocular irritaion was assessed by single topical application of ca. 50 µL bulk volume (about 25 mg) of the undiluted test substance to a reconstructed three dimensional human cornea model (EpiOcularTM).
Two EpiOcularTMtissues 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 ot mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues was compared to that of negative control tissues. The ratio of both values indicated the realtive tissue viability.
The following test results were obtained in the EpiOcularTM eye irritation test:
The test substance was able to reduce MTT directly. Therefore an additional MTT reduction control KC (freeze-killed control tissues) was introduced.
In a pre-test it was demonstraed that the color of the test substance did not interfere with the colorimetric test.
The mean viability of the test substance treated tissues was 96.8 %. All acceptance criteria were met.
The test substance does not show an eye irritation potential in the EpiOcularTMin vitro eye irritation test. Therefore the substance has not to be classified according to Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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