Yttrium oxide

Endpoint summary

Description of key information

Skin Irritation / Corrosion:
Yttrium Oxide is not a dermal irritant.
Eye Irritation / Corrosion:
Yttrium oxide is slightly irritating to the eye but not classified according to EU criteria.  

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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.

Qualifier:

equivalent or similar to guideline

Guideline:

other: 16CFR 1500-41

Deviations:

not specified

Principles of method if other than guideline:

no data

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Type of coverage:

occlusive

Preparation of test site:

other: one intact and one abraded skin site

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

undiluted / 0.5 g

Duration of treatment / exposure:

24 hour(s)

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE:
- Area of exposure: ca. 2.5 cm²
- % coverage: data not available
- Type of wrap if used: data not available

REMOVAL OF TEST SUBSTANCE:
- Washing: yes (the test sites were wiped)
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

8

Reversibility:

other: no relevant because no effect observed

Irritant / corrosive response data:

There were no signs of dermal irritation. Yttrium oxide is not considered to be a skin irritant.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification: not irritating

Executive summary:

In a primary dermal irritation study (Lambert CE et al, 1993), 6 New Zealand Albino rabbits were dermally exposed to 0.5 g of yttrium oxide (purity unknown) for 24 hours to ca. 2.5 cm² of one intact and one abraded skin site. Test sites were covered with an occlusive dressing for 24 hours. Animals were then observed for 3 days. Irritation was scored by the method of Draize.

In this study, yttrium oxide is not a dermal irritant.

This skin irritation study is classified as acceptable. It does satisfy the guideline requirement for a skin irritation study (16CFR 1500 -41) in the rabbit

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

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

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

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
- Tool used to assess score: data not available

Irritation parameter:

other: Draize scores

Basis:

mean

Remarks:

of 3 rabbits

Time point:

other: 24, 48 and 72 hours

Score:

0.7 - 13

Max. score:

110

Remarks on result:

other: Unwashed: 13 (24h) ; 3.7 (48h) ; 0.7 (72h)

Irritation parameter:

other: Draize scores

Basis:

mean

Remarks:

of 3 rabbits

Time point:

other: 24, 48 and 72 hours

Score:

0 - 9

Max. score:

110

Remarks on result:

other: Washed: 9 (24h) ; 2 (48h) ; 0 (72h)

Irritant / corrosive response data:

Yttrium oxide is considered to be mildly and minimally irritating to the unwashed and washed eye respectively.

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification: not irritating

Executive summary:

In a primary eye irritation study (Lambert CE, 1993), 0.1 g of yttrium oxide (purity unknown) was instilled into the left eye of New Zealand Albino rabbits (6 animals). 3 treated eyes were rinsed after 30 seconds. Animals were then observed for 3 days. Irritation was scored by the method of Draize.

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin and eye irritation were tested in vivo by Lambert et al, 1993. The study was evaluated as reliability 2 according to the Klimisch quotation. In a primary dermal irritation study, 6 New Zealand Albino rabbits were dermally exposed to 0.5 g of yttrium oxide (purity unknown) for 24 hours to ca. 2.5 cm² of one intact and one abraded skin site. Test sites were covered with an occlusive dressing for 24 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize. No relevant irritation was observed and the study concluded that Yttrium Oxide doesn't show any dermal irritation properties. For the eye irritation study part, 0.1 g of yttrium oxide (purity unknown) was instilled into the left eye of New Zealand Albino rabbits (6 animals). 3 treated eyes were rinsed after 30 seconds. Animals then were observed for 3 days. Irritation was scored by the method of Draize, showing slightly irritations but no classification should be proposed according to the criteria of the 12752/2008/EC regulation.

Justification for selection of skin irritation / corrosion endpoint:
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.

Justification for selection of eye irritation endpoint:
The study is described in a brief summary. However, the most important information 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.

Justification for classification or non-classification

Skin irritation: As Yttrium Oxide did not induce any skin irritation effects, it does not need to be classified according to classification criteria of 1272/2008/EC  

Eye irritation: Yttrium Oxide is slightly irritating to the eye, but does not need to be classified according to classification criteria of 1272/2008/EC.