Registration Dossier
Registration Dossier
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EC number: 271-591-2 | CAS number: 68585-82-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- data not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is described in a brief summary. However, the most important informations are given, so that the study can be judged as scientifically acceptable for the risk assessment. In order to limit animal testing, no other assay was conducted.
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute toxicological evaluation of yttrium oxide
- Author:
- Lambert CE, Barnum EC, Shapiro R
- Year:
- 1 993
- Bibliographic source:
- J Am Coll Toxicol, 12(6), 630
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EPA OPPTS 870.2400 (Acute eye irritation)
- Deviations:
- not specified
- Principles of method if other than guideline:
- data not available
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Yttrium oxide
- EC Number:
- 215-233-5
- EC Name:
- Yttrium oxide
- Cas Number:
- 1314-36-9
- Molecular formula:
- O3Y2
- IUPAC Name:
- Yttrium (III) oxide
- Details on test material:
- - Test material identity: Yttrium oxide (CAS 11130-29-3)
* Molecular formula: O-Y
* Molecular weight: 104.9
* Smiles notation: data not available
* InChI: yttrium oxide
- Analytical purity: data not available
- Impurities: data not available
- Lot/batch No: data not available
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: data not available
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source, Age at study initiation, Weight at study initiation, Housing, Diet, Water, Acclimation period: data not available
ENVIRONMENTAL CONDITIONS:
- Temperature, Humidity, Air changes, Photoperiod: data not available
IN-LIFE DATES: data not available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye of each rabbit was untreated
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 g - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- - Removal of test system: 3 of the treated eyes were rinsed with saline 30 seconds post-instillation
- Scoring system: according to the method of Draize (1944). Eyes were examined at 24, 48 and 72 hours.
- Tool used to assess score: data not available
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- of 3 rabbits
- Time point:
- 24 h
- Score:
- 13
- Max. score:
- 110
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- other: Mean total scores (unwashed)
- Basis:
- mean
- Remarks:
- of 3 rabbits
- Time point:
- other: at 24, 48 and at 72 hours
- Score:
- >= 0.7 - <= 13
- Max. score:
- 110
- Remarks on result:
- other: Unwashed: 13 (24h); 3.7 (48h); 0.7 (72h)
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- of 3 rabbits
- Time point:
- 24 h
- Score:
- 9
- Max. score:
- 110
- Remarks on result:
- other: Washed
- Irritation parameter:
- other: Mean total scores (washed)
- Basis:
- mean
- Remarks:
- of 3 rabbits
- Time point:
- other: at 24, 48 and at 72 hours
- Score:
- >= 0 - <= 9
- Max. score:
- 110
- Remarks on result:
- other: Washed: 9 (24h); 2 (48h); 0 (72h)
- Irritant / corrosive response data:
- - Individual (total) scores are not available. Only the mean of the 3 rabbits, as reported above: no further details are available.
- Yttrium oxide is considered to be mildly and minimally irritating to the unwashed and washed eye, respectively. Based on the MMTS.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a primary eye irritation study, 0.1 g of yttrium oxide (purity unknown) was instilled into the left eye of New Zealand Albino rabbits (6 animals). Three treated eyes were rinsed after 30 seconds. Animals were then observed for 3 days. Irritation was scored by the method of Draize (1944). In this study, yttrium oxide is slightly irritating to the eye, but not classified according to EU criteria. This eye irritation study is classified as acceptable. It does satisfy the guideline requirement for an eyes irritation study (OPPTS 870.2400) in the rabbit
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