Registration Dossier
Registration Dossier
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EC number: 235-060-9 | CAS number: 12064-62-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Study conducted in accordance with generally accepted scientific principles, with incomplete reporting or methodological deficiencies. However, as most basic key information is reported, the study can be judged as scientifically acceptable. In order to limit animal testing, no other assay was conducted.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US guideline, not specified in the source publication
- Principles of method if other than guideline:
- The test item was applied on intact and abraded skin of New Zealand Albino rabbits and occluded for 24 h. Sites were evaluated 24 and 72 h after initial exposure according to the method of Draize.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Digadolinium trioxide
- EC Number:
- 235-060-9
- EC Name:
- Digadolinium trioxide
- Cas Number:
- 12064-62-9
- Molecular formula:
- Gd2O3
- IUPAC Name:
- Digadolinium trioxide
- Details on test material:
- No further data available
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
No further data available.
ENVIRONMENTAL CONDITIONS
No further data available.
IN-LIFE DATES: No further data available.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other:
- Remarks:
- One intact and one abraded skin site per animal was treated
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted / 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
The sites were evaluated 24 and 72 hours after initial exposure. - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: ca. 2.5 cm²
- % coverage: No data
- Type of wrap if used: No data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (the test sites were wiped)
- Time after start of exposure: 24 hours
SCORING SYSTEM:
- Method of calculation: According to Draize (1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritant / corrosive response data:
- There were no signs of dermal irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not irritating
- Conclusions:
- The test material was not irritating under the conditions of this test. Therefore, the test item is not classified according to CLP regulation.
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