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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:
weight of evidence
Study period:
from 16-OCT-1995 to 08-MAR-1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Reaction mass of cerium dioxide and zirconium dioxide
IUPAC Name:
Reaction mass of cerium dioxide and zirconium dioxide
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Poudre catalytique à base d'oxyde de cérium et d'oxyde de zirconium (OBD 30)
- Substance type: multi-constituent substance
- Physical state: yellow powder
- Further information 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: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.5 +/- 0.4 kg
- Housing: individually in polystyrene cages (35x55x32 cm or 48.2x58x36.5 cm)
- Diet (e.g. ad libitum): free access to 112 pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): drinking water filtered by a Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h / 12h

IN-LIFE DATES: From: 22 nov 1995 To: 29 nov 1995

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Observation period (in vivo):
One hour, 24, 48 and 72 hours after the administration and then daily for 4 days at the latest.
Reversibility of ocular lesions was observed on day 4 (two animals) or 8.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE: not rinsed
SCORING SYSTEM: according to EEC Criteria
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Other effects:
Clear ocular discharge was observed in 2 rabbits for 24 or 48 hours after administration of the test substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The reaction mass of cerium dioxide and zirconium dioxide was found to be slightly irritating to rabbit eyes, however, the observed effects did not reach the classification limits under the CLP Regulation and therefore the reaction mass is not classified for eye irritation under the CLP Regulation.


Executive summary:

In a primary eye irritation study (CIT, 1996), 100 mg of the reaction mass of cerium dioxide and zirconium dioxide was instilled into the conjunctival sac of the left eye of New Zealand White rabbits (3 animals). Eyes were not rinsed and the right eye served as control. The ocular examinations were performed 1, 24, 48 and 72 hours after instillation.

Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.0 and 1.3 for chemosis, 0.3, 1.0 and 2.3 for redness of the conjunctivae, 0.0, 0.0 and 0.7 for iris lesions and 0.7, 0.3 and 1.3 for corneal opacity. Total reversibility was observed by day 4 (2 animals) or day 8.

In this study, the reaction mass of cerium dioxide and zirconium dioxide is not classified as eye irritant based on the EU classification criteria.

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