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EC number: 234-546-8 | CAS number: 12009-21-1
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- In vitro Assessment of the eye irritation potential of Barium Zirconate according to OECD guideline TG492 (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
- Principles of method if other than guideline:
- This in vitro risk assessment assay predicts the acute eye irritation potential of a chemical by measurement of its cytotoxic effect on the EpiOcular™ corneal epithelial model.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Barium zirconium trioxide
- EC Number:
- 234-546-8
- EC Name:
- Barium zirconium trioxide
- Cas Number:
- 12009-21-1
- Molecular formula:
- BaO3Zr
- IUPAC Name:
- barium(2+);oxygen(2-);zirconium(4+)
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Supplier Thermograde Process Technology
Test Item name Barium Zirconate
Supplier batch/lot number 17/1791
CAS number 12009-21-1
Purity 99.17
Expiry Date 27 Sep 2020
Physical state Powder (white)
Storage Conditions Room Temp.
Solubility Not supplied as unknown
Administration method Topical application
Concentration tested Neat
XCellR8 test item code RCS001
Study test item code TA1
Test animals / tissue source
- Species:
- human
- Strain:
- other: The EpiOcularTM tissue model (OCL-200-MatTek Corporation) is composed of stratified human keratinocytes in a three-dimensional structure, reflecting the morphology and function of the human corneal epithelium found in vivo
- Details on test animals or tissues and environmental conditions:
- MatTek’s EpiOcularTM system consists of normal, human-derived keratinocytes which have been cultured to form a stratified, squamous epithelium similar to that found in the cornea. Cultured on specially prepared cell culture inserts using serum-free culture medium, the cells differentiate to form a multi-layered structure with progressively stratified, but not cornified cells which closely parallel the corneal epithelium
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- After pre-wetting tissues with 20µl PBS (sterile Dulbecco’s Phosphate Buffered Saline) for 30 minutes ± 2 minutes, a single, topical application of a levelled spoonful (designed to hold approximately 50mg) of neat test item, or 50µl of reference items was applied to the surface of the EpiOcularTM model
- Duration of treatment / exposure:
- 6 hours ± 15 minutes, followed by a 25 minutes ± 2 minutes post-treatment immersion, and 18 hours ± 15 minutes post-treatment incubation
- Duration of post- treatment incubation (in vitro):
- a 25 minutes ± 2 minutes post-treatment immersion, and 18 hours ± 15 minutes post-treatment incubation
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Prior to the study, the required preliminary test confirmed that the test item did not interfere with MTT but did interfere with solvent. Therefore, colourant controls were included.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % of viability
- Run / experiment:
- Mean of three replicates
- Value:
- 109.16
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Acceptance criterion 1:The mean OD570 of the negative control (treated with sterile water) tissues is > 0.8 and < 2.5. Result = 2.142 PASS
Acceptance criterion 2: The mean of the positive control relative percentage viability is below 50% of negative control viability after 6 hours exposure.
Result = 19.567 PASS
Acceptance criterion 3: The SD of % viability between three tissue replicates should not exceed 18% in the same run (for negative and positive control tissues and tissues of test items). NC: 10.347; PC: 4.455; TA1: 7.496. Result = PASS
All acceptance criteria were met during the study.
Any other information on results incl. tables
Condition |
Tissue # |
Raw Data |
Blank Corrected Data |
Mean OD |
% Viability |
||
Aliquot 1 |
Aliquot 2 |
Aliquot 1 |
Aliquot 2 |
||||
NC |
Tissue 1 |
1.991 |
2.153 |
1.830 |
1.992 |
1.911 |
89.224 |
Tissue 2 |
2.506 |
2.522 |
2.345 |
2.361 |
2.353 |
109.858 |
|
Tissue 3 |
2.421 |
2.224 |
2.260 |
2.063 |
2.162 |
100.918 |
|
PC |
Tissue 1 |
0.692 |
0.688 |
0.531 |
0.527 |
0.529 |
24.710 |
Tissue 2 |
0.529 |
0.516 |
0.368 |
0.355 |
0.362 |
16.891 |
|
Tissue 3 |
0.518 |
0.536 |
0.357 |
0.375 |
0.366 |
17.101 |
|
TA1 |
Tissue 1 |
2.451 |
2.202 |
2.290 |
2.041 |
2.166 |
101.105 |
Tissue 2 |
2.633 |
2.655 |
2.472 |
2.494 |
2.483 |
115.926 |
|
Tissue 3 |
2.442 |
2.612 |
2.281 |
2.451 |
2.366 |
110.464 |
NC: negative control (sterile water), PC: Positive control (neat Methyl Acetate), TA1: Barium Zirconate.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the eye irritation potential of Barium Zirconate was assessed in vitro according to OECD Test 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).
After 6 hours ± 15 mins exposure on the surface of EpiOcularTM reconstructed ocular epithelium and 18 hours ± 15 mins post-incubation time, the viability of the tissues was assessed and compared to a negative control.
The percentage viability obtained was 109.161% and therefore: Barium Zirconate was classified as No Category i.e. not requiring a warning label in the European chemical classification systems for eye irritation or serious eye damage.
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