Registration Dossier
Registration Dossier
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EC number: 436-100-1 | 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 No. 404 EC Directive 92/69/EEC Annex V Test B.4
- GLP compliance:
- yes
Test animals
- Species:
- other: New Zealand white rabbits.
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: SNEA applied as supplied.
- 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:
- 1.33
- 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:
- 1.33
- Irritation parameter:
- erythema score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 48 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:
- 1.33
- 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:
- 0.66
- Irritation parameter:
- edema score
- Max. score:
- 2
- 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 not fully reversible within 27 days
- Other effects:
- Test site hardening and thickening was noted in 2 animals24h after patch removal. Scabbing was noted at the testsite of the remaining animal 72h after patch removal.No animal had fully recovered by the end of the observationperiod. Skin at the test site was thickened, hardened andscabbed up to the end of the observation period 27 daysafter patch removal. On the basis of the test sitehardening and scabbing, SNEA has been classified as anirritant.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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