Registration Dossier

Administrative data

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.

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:
other: 16CFR 1500-41
Deviations:
not specified
Principles of method if other than guideline:
no data
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

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

Results and discussion

In vivo

Results
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.

Applicant's summary and conclusion

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