Registration Dossier
Registration Dossier
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EC number: 606-728-0 | CAS number: 212322-56-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Oct 1997 - 12 Jan 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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:
- ethyl 3-{1-[3-amino-4-(methylamino)phenyl]-N-(pyridin-2-yl)formamido}propanoate
- EC Number:
- 606-728-0
- Cas Number:
- 212322-56-0
- Molecular formula:
- C18 H22 N4 O3
- IUPAC Name:
- ethyl 3-{1-[3-amino-4-(methylamino)phenyl]-N-(pyridin-2-yl)formamido}propanoate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test Animals
- the animals were approximately 32-49 weeks
- the body weight range were 3.9-4.8 kg on Day 1
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- three plasters with 0.5 g pasty/plaster (corresponding to 307.7 mg test substance per plaster)
- Duration of treatment / exposure:
- 3 min - 4 hrs
- Observation period:
- 7 days
- Number of animals:
- 2 male and 2 female
- Details on study design:
- All animals behaved unobtrusively throughout the study period. No effect on food and water consumption was observed by visual inspection.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1h/24h/48h/72h/7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: not skin irritating
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1h/24h/48h/72h/7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: not skin irritating
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1h/24h/48h/72h/7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: not skin irritating
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 1h/24h/48h/72h/7days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: not skin irritating
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1h/24h/48h/72h/7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: not skin irritating
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1h/24h/48h/72h/7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: not skin irritating
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1h/24h/48h/72h/7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: not skin irritating
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 1h/24h/48h/72h/7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: not skin irritating
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. CLP
- Conclusions:
- The test substance BIBR 1048/CDBA 122 BS is considered not to be skin irritating or caustic.
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