Barium zirconium trioxide

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:

2018

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

Test material information

Constituent 1

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

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.