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Diss Factsheets
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EC number: 948-208-9 | 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:
- December 12, 2017 - December 14, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- 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:
- October 9, 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular™ Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals; For use with MatTek Corporation's Reconstructed Human EpiOcular Model; MatTek Corporation
- Version / remarks:
- June 29, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: DB-ALM Protocol No. 164: Ocular Irritation Assay for Chemicals using EpiOcular™ EIT
- Version / remarks:
- September 14, 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Titanium zirconium oxide
- EC Number:
- 948-208-9
- Molecular formula:
- TixZryOz (x = 0.985 - 0.995, y = 1-x, z = 1.65 - 1.75)
- IUPAC Name:
- Titanium zirconium oxide
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability
:
The reconstructed human comea-like epithelium (RhCE) model is an accepted in vitro method to replace animal testing. The human eye Epiocular™-model closely mimics the biochemical and physiological properties ofthe human eye, i.e. the comea.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live: The Epiocular™-model is a nonkeratinized epithelium prepared from normal human keratinocytes. lt models the cornea epithelium with progressively stratified, but not cornified cells. lt is used for eye irritation testing.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 mg
The test item was applied neat to the tissues. - Duration of treatment / exposure:
- 6 hours +/- 15 minutes
- Duration of post- treatment incubation (in vitro):
- 18 hours +/- 15 min
- Number of animals or in vitro replicates:
- two tissues
- Details on study design:
- - Details of the test procedure used
- RhCE tissue construct used, including batch number: EpiOcular™ Tissue (OCL-200, OCL-212), Lot No. 27017
- Doses of test chemical and control substances used: 50 mg test item, 50 µL negative control, 50 µL positive control
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods: 6 hours (+/- 15 min) at 37°C, 25 min (+/- 2 min) at room temperature, 18 hours (+/- 15 min) at 37°C
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals: A pre-test for direct MTT-reducing capacity of the test item was conducted and the test item was checked for its colorant properties.
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable): 2 tissues (test item, positive control, negative control), 2 tissues to assess direct MTT reduction and staining test items, respectively
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer): 570 nm, ELx800, BioTek Instruments GmbH
- Description of the method used to quantify MTT formazan: To extract the MTT, the plates was placed on an orbital plate shaker and shaken for 2 to 3 hours at room temperature. The extract solution was mixed and 2 x 200 μL were transfe1Ted into a 96-well plate. The OD was read using a spectrophotometer at 570 nm wavelength.
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model: If the test item-treated tissue viability is >60.0% relative to negative control-treated tissue viability, the test item is labeled non-irritant (UN GHS No Category). If the test item-treated tissue viability is less than or equal to 60.0% relative to negative control-treated tissue viability, the test item is labeled irritant (UN GHS Category 1 or Category 2).
- Acceptability of the Test:
- The negative control OD is >0.8 and <2.5
- The mean relative viability of the positive control is below 50% of the negative control viability.
- The difference of viability between the two relating tissues of a single chemical is <20% in the same run (for positive and negative control tissues and tissues of single chemicals).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Cell viability (%)
- Run / experiment:
- Tissue 1
- Value:
- 93
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Cell viability (%)
- Run / experiment:
- Tissue 2
- Value:
- 107
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions ofthe present study, the test item did not show an eye hazard potential. The test item is labeled non-irritant (UN GHS: No Category).
- Executive summary:
The objective of the present study was to investigate the potential of the test item to induce eye irritation in an in vitro human cornea model.
The test item was applied topically to a reconstructed human cornea-like epithelium model (Epiocular™) followed by determination of the cell viability. Cell viability was determined by enzymatic conversion of vital dye MTT into a blue formazan salt and measurement of the formazan salt after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict the eye irritation potential. Duplicates of the Epiocular™-model were treated with the test item, the negative or the positive control for 6 hours (± 15 minutes). 50 mg of the test item and 50 μL of either the negative control (sterile deionized water) or the positive control (methyl acetate) were applied to the tissues.
After treatment with the negative control (sterile deionized water) the mean OD was 1.509 (study acceptance criterion: >0.8 and <2.5). Treatment with the positive control (methyl acetate) revealed a mean viability value of 47.0% (study acceptance criterion: <50%). Thus, the acceptance criteria were met.
Following treatment with the test item, the tissue viability was 85.7% and, thus, higher than 60%, i.e. according to OECD 492 the test item is labeled non-irritant (UN GHS: No Category).
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