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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 60±1 minute exposure on the surface of the EpiDermTM reconstructed human epidermis, and a 42 ±4 hours post-exposure incubation time
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Optical Density (OD) values obtained with blanks were higher than 0.1 (0.160) causing a deviation from Acceptance Criteria 4. This deviation was not considered to have affected the integrity or interpretation of the results.
- Principles of method if other than guideline:
- In vitro assessment of the skin irritation potential of Barium Zirconate according to OECD guideline TG439: In vitro Skin Irritation: Reconstructed Human Epidermis (RHE) Test Method.
This in vitro risk assessment assay predicts the skin irritation potential of a chemical by measurement of its cytotoxic effect on the EpiDerm™ tissue model.
The detailed method followed in this study is described in XCellR8 SOP L0029: “EpiDermTM In vitro Reconstructed Human Epidermis Skin Irritation Test (OECD 439 28 Jul 2015 and is based on the MatTek protocol (MK-24-007-0023, 03 January 18) using the MatTek Corporation EpiDermTM reconstructed tissue model EPI-200. - 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.
Administration method Topical application
Concentration tested Neat
XCellR8 test item code RCS001
Study test item code TA1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis
- Cell source:
- other: . It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- After pre-wetting tissues with 25µl DPBS (Sterile Dulbecco’s Phosphate Buffered Saline) a single, topical application of nominal 25mg neat test item or 30µl of negative control (DPBS) or positive control (SDS 5%) to the surface of the EpiDermTM model for 60±1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% Relative Humidity (RH)), followed by 42±4 hours post-treatment incubation, prior to the MTT endpoint; three tissues per condition (n=3).
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- a single, topical application of nominal 25mg neat test item or 30µl of negative control (DPBS) or positive control (SDS 5%) to the surface of the EpiDermTM model
- Duration of treatment / exposure:
- 60±1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% Relative Humidity (RH)
- Duration of post-treatment incubation (if applicable):
- 42±4 hours post-treatment incubation
- Number of replicates:
- Three
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean result of three replicates
- Value:
- 101.12
- 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 DPBS) tissues must be ≥ 0.8 and ≤ 2.8 Result = 1.928 PASS
Acceptance criterion 2: The mean of the positive control relative percentage viability must be ≤ 20% of the mean of the negative controls. Result = 2.861 PASS
Acceptance criterion 3: The standard deviation of viability percentages for triplicate skin models in each experimental condition must be < 18%
NC: 5.209, PC: 0.853, TA1: 8.557 = PASS
Acceptance criterion 4: The mean OD of the 6 wells containing extraction solvent alone (blanks) must be ≤ 0.1. Result = 0.160 ACCEPT*
*All acceptance criteria were met except for criterion 4:
Optical Density (OD) values obtained with blanks were higher than 0.1 (0.160) causing a deviation from Acceptance Criteria 4. However, the spectrophotometer was fully validated and had passed all required tests. The OD values for blanks observed in this study are consistent with historical data using this spectrophotometer in the XCellR8 laboratory and meet our current internal acceptance criteria of blank OD values <0.244 (mean of XCellR8 historical data +2SD, based on blanks obtained during 88 historic runs), therefore this is not considered to be an issue in the interpretation of this study data.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the skin irritation potential of Barium Zirconate was assessed in vitro according to OECD Test Guideline 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method. After 60±1 minute exposure on the surface of the EpiDermTM reconstructed human epidermis, and a 42 ±4 hours post-exposure incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 101.124 % and therefore:
Barium Zirconate was classified as Non-Irritant to the skin.
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