Registration Dossier
Registration Dossier
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EC number: 271-591-2 | CAS number: 68585-82-0
Skin irritation / corrosion
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:
- 1 993
- Bibliographic source:
- J Am Coll Toxicol, 12(6), 630
Materials and methods
Test guideline
- 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
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
- 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
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
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scored 24 and 72 hours after initial exposure
- Irritant / corrosive response data:
- There were no signs of dermal irritation. After 24 hours of exposure under occlusive conditions. All scores were 0. Yttrium oxide is not considered to be a skin irritant.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- 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
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