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Diss Factsheets
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EC number: - | 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
- Study period:
- 2021-01-13 to 2021-01-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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)
- Version / remarks:
- 2019-06-18
- Deviations:
- yes
- Remarks:
- In the pre-test for Colour Interference the absorption of the test item water solution in the range of 570 nm was not evaluated by OD measurement. No historical data of pos. and neg. control are available.
- GLP compliance:
- yes
Test material
- Reference substance name:
- titanium, iron, aluminium oxide
- Molecular formula:
- x(Al, Fe)2TiO5 * yTiO2
- IUPAC Name:
- titanium, iron, aluminium oxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Chemical description: Titanium, iron and aluminium pseudobrookite and rutile
- Physical state: Solid, brown powder, odourless
- Crystal structure: pseudobrookite and rutile
- Purity : ~ 98%
- Storage condition of test material: Kept dry in closed containers
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- JUSTIFICATION OF THE TEST METHODS AND CONSIDERATIONS REGARDING APPLICABILITY:
This in vitro method is recommended to identify chemicals that do not require classification for eye irritation or serious eye damage according to UN GHS (UN GHS “No Category”) without further testing within a tiered testing strategy from those requiring classification and labelling (UN GHS categories 1 and 2). Therefore, it can be used for regulatory purposes as an initial step in the bottom-up approach or as one of the last steps in a top-down approach to test eye irritation/corrosion potential. It is not intended to differentiate between UN GHS “Category 1” (serious eye damage) and UN GHS “Category 2” (eye irritation) which would require additional testing. Ocular irritation potential is predicted by the relative viability of the tissue after a single exposure to the test substance. Relative viability is determined by measuring the MTT dye to formazan conversion by the EpiOcular™ tissue construct after topical exposure to the test substance.
RhCE TISSUE CONSTRUCT USED: EpiOcular™ (Lot No.:31770; OCL-200-EIT and MTT-100 assy kit; source: MatTek Corporation (82105 Bratislava, Slovakia))
The test was carried out with the EpiOcular™ reconstructed human cornea-line epithelium (RhCE) model (MatTek). The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a stratified, highly differentiated squamous epithelium morphologically similar to that found in a human cornea. The EpiOcular™ RhCE tissue construct consists of at least 3 viable layers of cells and a non-keratinized surface, showing a cornea-like structure analogous to that found in vivo.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg of the neat test substance was applied to the tissue surface. All tissues were pre-wetted with 20 µL DPBS prior application and incubated for 30 min at 37.2 °C. - Duration of treatment / exposure:
- 6 hours
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- about 18 hours
- Number of animals or in vitro replicates:
- Number of EpiOcular tissues per group: duplicates
- Details on study design:
- PRE-TEST FOR MTT INTERFERENCE
Approximately 50 mg of test substance or 50 μL deionized water (control) was added to 1 mL aliquot of MTT medium. After ~3 hours of incubation (37.2 - 37.4 °C, 5% CO2), the mixtures were evaluated for change in coloration to purple/blue.
PRE-TEST FOR COLOUR INTERFERENCE
Approximately 50 mg of the test substance was added to both 1 mL of deionized water and 2 mL of isopropanol. After 60 minutes of incubation (37.2 - 37.4 °C, 5% CO2) in deionized water, or 3 hours at ambient temperature in isopropanol. The water solution was evaluated for the presence and intensity of staining/coloration. For the isopropanol solution the absorption in the range of 570±20 nm was evaluated by OD measurement.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE AND COLOUR INTERFERENCE
Since the test item/ water and test item/ isopropanol solutions did not change colour and the test item did not interfere with MTT, no additional tissues were necessary in the main experiment.
DETAILS OF THE TEST PROCEDURE USED
- Pre-warming:
EpiOcularTM tissues were equilibrated at room temperature for 15 min. The inserts with the tissues were transferred into 6-well-plates containing 1.0 ml assay medium and incubated for 60 minutes (37.2 °C, 5 % CO2). Afterwards, the medium was changed and a further pre-incubation for approximately 16 hours (37.0 - 37.3 °C, 5 % CO2) follows.
-Pre-treatment:
After pre-warming and prior to application of the test item respectively the controls, all tissues were pre-wetted with 20 µL DPBS and incubated for 30 min (37.2 °C, 5 % CO2).
- Treatment/Exposure:
Concurrent negative and positive control were applied at a volume of 50 µL and for the test substance 50 mg to the tissue surface and incubated for 6 h in assay medium (37.1 - 37.3 °C, 5 % CO2)
- Rinsing:
Afterwards all tissues were rinsed 3 times in 100 - 150 mL DPBS.
- Post-exposure immersion:
The inserts were transferred to new 12-well plates containing 5 ml assay medium and incubated for 35 min at room temperature and allowed to soak.
Post-exposer incubation:
The tissues were transferred into a 6-well plate with 1 ml assay medium and were incubated for a for about 18 h (37.3 °C, 5 % CO2).
- MTT Assay:
The tissues were placed into the 24-well plate containing 300 µL of MTT (1 mg/ mL) solution and were incubated for 3 hours (37.2 °C, 5 % CO2).
The inserts were transferred to 6-well plates containing 1 mL of isopropanol in each well. Samples were shaken for 2 hours at room temperature on a plate shaker. A volume of 1 mL of isopropanol was added to the extraction solution and the solution was mixed in each well. Duplicate 200 μL aliquots of each were transferred into a 96-well plate. Isopropanol was used as blanks.
-Measurement:
Optical density (OD) was read in a 96-well plate spectrophotometer using a wavelength of 570 nm without using a reference filter.
TEST ACCEPTANCE CRITERIA
The test meets acceptance criteria:
- mean absolute OD570 nm of the negative control is > 0.8 and < 2.5
- mean relative tissue viability of the positive control is < 50%
- relative tissue viability difference of replicate tissues is < 20%
DESCRIPTION OF DATA EVALUATION
Optical density (OD) was read in a 96-well plate spectrophotometer using a wavelength of 570 nm without using a reference filter.
Blank corrected OD values were calculated by subtracting the OD of the blank wells from the OD of all other measured wells. The mean OD value of each pair of aliquots was then calculated for each tissue.
The mean corrected OD for treated viable tissues was calculated. The resulting mean OD for the negative control treated tissue corresponds to 100% viability for the assay.
Viability [%] = corrected test article OD / corrected mean negative control OD x 100
PREDICTION MODEL
If the test item-treated tissue viability is > 60% after exposure and post-exposure incubation relative to the negative control treated tissue viability, the test item is identified as not requiring classification and labelling according to UN GHS (No Category).
If the test item-treated tissue viability is ≤ 60% after exposure and post-exposure incubation relative to negative control treated tissue viability, the test is identified as irritant to eyes and requires classification and labelling according to UN GHS (Category 2).
Results and discussion
In vitro
Results
- Irritation parameter:
- mean percent tissue viability
- Value:
- 65.7
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- TEST FOR MTT INTERFERENCE
In the pre-experiment for MTT interference no significant colour change was noted, so the test item did not reduce MTT to Formazan salt.
TEST FOR COLOUR INTERFERENCE
In the pre-experiment for colour interference the test item did not change colour when mixed with deionised water or isopropanol. The connected OD of the test item isopropanol solution was well below 0.08.
ACCEPTANCE OF RESULTS:
- mean absolute OD570 nm of the negative control is > 0.8 and < 2.8 (1.850)
- mean relative tissue viability of the positive control is < 50% (47.5%)
- relative tissue viability difference of replicate tissues is < 20% (9.21 - 19.64)
Any other information on results incl. tables
Optical density and viability results I
Treatment Group |
Tissue No. |
Raw data OD 570 nm |
Blank Corrected data OD 570 nm |
Mean OD of aliquots |
% of viability |
||
Aliq. 1 |
Aliq. 2 |
Aliq. 1 |
Aliq. 2 |
||||
Blank |
|
- |
- |
- |
- |
0.0866 |
- |
Negative Control |
1 |
1.8371 |
1.8662 |
1.751 |
1.780 |
1.765 |
95.4 |
2 |
2.0065 |
2.0375 |
1.920 |
1.951 |
1.935 |
104.6 |
|
Positive Control |
1 |
0.8543 |
0.8567 |
0.768 |
0.770 |
0.769 |
41.6 |
2 |
1.0846 |
1.0658 |
0.998 |
0.979 |
0.989 |
53.4 |
|
Test Item |
1 |
1.1152 |
1.1261 |
1.029 |
1.040 |
1.034 |
55.9 |
2 |
1.4841 |
1.4839 |
1.398 |
1.397 |
1.397 |
75.5 |
Optical density and viability results II
Substance |
Average Optical Density reading |
SD (Optical Density) |
Average % Viability |
SD (Viability) |
Test Item |
1.216 |
0.363 |
65.7 |
19.64 |
Negative Control (deionized water) |
1.850 |
0.170 |
100.0 |
9.21 |
Positive Control (methyl acetate) |
0.879 |
0.220 |
47.5 |
11.87 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in this study and under the experimental conditions reported, Titanium, iron and aluminium pseudobrookite and rutile is non-irritant to eyes and does not require classification and labelling for eye irritation or serious eye damage according to UN GHS and EU CLP.
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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