Registration Dossier
Registration Dossier
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EC number: 449-980-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002).
- GLP compliance:
- yes
Test animals
- Species:
- other: New Zealand White rabbit
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Test substance was moistened with 0.5 ml of distilled water.
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.67
- Irritation parameter:
- erythema score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 72 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- Very slight erythema was noted at one treated skin site at
the 24 and 48-hour observations. This treated skin site
appeared normal at the 72-hour observation.
The remaining two treated skin sites appeared normal
throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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