Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 909-709-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 1 996
- 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
- Reference substance name:
- Reaction mass of cerium dioxide and zirconium dioxide
- EC Number:
- 909-709-8
- Molecular formula:
- (Ce, Zr)O2
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
