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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:
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:
1993
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

Constituent 1
Chemical structure
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

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