Registration Dossier
Registration Dossier
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EC number: 454-450-1 | CAS number: 429659-01-8 BIBR 1048 MANAMIDE
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
- EC Number:
- 454-450-1
- EC Name:
- Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
- Cas Number:
- 429659-01-8
- Molecular formula:
- C18 H20 N4 O5
- IUPAC Name:
- ethyl 3-{1-[4-(methylamino)-3-nitrophenyl]-N-(pyridin-2-yl)formamido}propanoate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- HsdIf_NZW
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: carboxymethylcellulose 1%
- 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:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Other effects:
- No observed effects.
Applicant's summary and conclusion
- Interpretation of results:
- other: no classification required
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item BIBR 1048 Manamide showed neither irritant nor corrosive effects.
The test item BIBR 1048 Manamide does not have to be classified and has no obligatory labelling requirement for skin irritation.
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