Registration Dossier
Registration Dossier
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EC number: 470-710-7 | CAS number: 139122-17-1
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: Annex V
- GLP compliance:
- yes
Test animals
- Species:
- other: Rabbit (New Zealand White)
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: The test material as supplied was moistened with 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:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.66
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 72 d; Max. value at end of observation period: 1 (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:
- 0.33
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.66
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Irritation parameter:
- edema score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 48 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 to well-defined erythema was noted at all
treatment sites one hour after patch removal and at the 24
and 48-hour observatons. Very slight erythema was noted at
two treated skin sites at the 72-hour observation.
Very slight oedema was noted at all treated skin sites 1 and
24 hours after patch removal and at one treated skin site
at the 48-hour observation.
Barely perceptible desquamation was noted at one treated
skin site a the 7-day observation.
Two treated skin sites appeared normal at the 7-day
observation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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