Registration Dossier
Registration Dossier
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EC number: 700-258-0 | CAS number: 125971-95-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- increased humidity for 2 day in convential animal rooms, no influence to the results of study
- GLP compliance:
- yes
Test material
- Reference substance name:
- tert-butyl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate
- EC Number:
- 700-258-0
- Cas Number:
- 125971-95-1
- Molecular formula:
- C40H47FN2O5
- IUPAC Name:
- tert-butyl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: substance moistened with smallest amounth of water
- Controls:
- no
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- initial test 3min, 1hour, 4hours
test 4hours - Observation period:
- 1, 24,48,72hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour, 24hours, 48 hours, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 hour, 24hours, 48 hours, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hour, 24hours, 48 hours, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 hour, 24hours, 48 hours, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 hour, 24hours, 48 hours, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 hour, 24hours, 48 hours, 72 hours
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
| Time after 4 -hours exposure | Rabbit No.1 | Rabbit No.2 | Rabbit No.3 | ||||
| 1 hour | Erythema | 0 | Erythema | 0 | Erythema | 0 | |
| Oedema | 0 | Oedema | 0 | Oedema | 0 | ||
| 24 hours | Erythema | 0 | Erythema | 0 | Erythema | 0 | |
| Oedema | 0 | Oedema | 0 | Oedema | 0 | ||
| 48 hours | Erythema | 0 | Erythema | 0 | Erythema | 0 | |
| Oedema | 0 | Oedema | 0 | Oedema | 0 | ||
| 72 hours | Erythema | 0 | Erythema | 0 | Erythema | 0 | |
| Oedema | 0 | Oedema | 0 | Oedema | 0 | ||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results no skin irritation was caused by substance.
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