Registration Dossier
Registration Dossier
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EC number: 231-397-0 | CAS number: 7531-52-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.8.2001 - 14.9.2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (S)-pyrrolidine-2-carboxamide
- EC Number:
- 231-397-0
- EC Name:
- (S)-pyrrolidine-2-carboxamide
- Cas Number:
- 7531-52-4
- Molecular formula:
- C5H10N2O
- IUPAC Name:
- (S)-pyrrolidine-2-carboxamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand Albino rabbits
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- A sample was moistened with the smallest amount water for injection, needed to ensure good contact with the skin.
- Controls:
- no
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Positive skin reaction (erythema, score 1) was detected in one animal at the 1 h reading. This effect was reversible within 24 h after removing the test substance. Two other animals were without any skin reaction. No other signs of intoxication were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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