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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-02-08 to 2000-03-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well documented, scientifically sound study according to a method similar to OECD guideline 405 with a few deviations. However, not GLP, no information on environmental conditions, individual eye endpoints (cornea, iris, conjunctiva) not reported in the results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
not GLP, no information on environmental conditions, individual eye endpoints (cornea, iris, conjunctiva) were not reported in the results
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Yttrium zirconium oxide
EC Number:
264-885-7
EC Name:
Yttrium zirconium oxide
Cas Number:
64417-98-7
Molecular formula:
(ZrO2)x (Y2O3)y 0.59 < x < 1.0 and 0 < y < 0.41
IUPAC Name:
Yttria-Stabilised Zirconia
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): zirconium oxide
- Molecular formula (if other than submission substance): 97ZrO2 3Y2O3 (mole fraction)
- Molecular weight (if other than submission substance): 126
- Analytical purity: 99.9 wt% (ZrO2 + Y2O3)
- Physical state: white powder
- Stability under test conditions: nonreactive to water
- Storage condition of test material: room temperature (10-30 degrees C)
- Further details on test material confidential

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Biotech Co., Ltd
- Age at study initiation: 4 months old
- Weight at study initiation: 3.22-3.59 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: no data To: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eyes were kept as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3 animals (administered to the left eye of each animal)
Details on study design:
SCORING SYSTEM: According to Draize's standard (1959). Cornea, iris and conjunctiva were observed, and acknowledged damages were recorded. After calculating the total scores of each observation of each animal (Individual ocular irritation index, IOI) and the average score of each observation of each group (Mean ocular irritation index, MOI), the evaluation was made according to the AFNOR (1982) evaluation criteria. The acute ocular irritation index (AOI) was defined as the maximum of the MOI.

Accident Value Test of Corneal Epithelium: After the accident value test of anterior ocular segment done 24 hours after the application, corneal epithelium were dyed with fluorescein, and the stainability was evaluated.

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: MOI
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 hour
Score:
4.7
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: MOI
Basis:
mean
Remarks:
of 3 animals
Time point:
24 h
Score:
6
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: MOI
Basis:
mean
Remarks:
of 3 animals
Time point:
48 h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: MOI
Basis:
mean
Remarks:
of 3 animals
Time point:
72 h
Score:
0
Max. score:
110
Reversibility:
other: not applicable
Irritation parameter:
other: AOI
Basis:
mean
Remarks:
of 3 animals
Time point:
24 h
Score:
6
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
The AOI was determined to be 6.0 at 24 hours and the MOI after 48 hours was 2.0, therefore, this test agent was determined to be slightly irritating based on the AFNOR (1982) criteria. No irritation was observed after 72 hours.

The Accident Value Test of Corneal Epithelium 24 hours after application was zero in all three animals.
Other effects:
There were no abnormalities in the general condition or the weight changes to any of the 3 animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test agent was determined to be slightly irritating based on the AFNOR criteria. It does however not need to be classified for eye irritation according to the CLP criteria.