Yttrium oxide (Y2O3), europium-doped

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:

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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)

Results 3

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

Results 4

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