Registration Dossier
Registration Dossier
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EC number: 609-904-5 | CAS number: 41263-74-5
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)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(methylamino)-3-nitrobenzoic acid
- EC Number:
- 609-904-5
- Cas Number:
- 41263-74-5
- Molecular formula:
- C8 H8 N2 O4
- IUPAC Name:
- 4-(methylamino)-3-nitrobenzoic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: shorn
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 181.8 mg test substance/plaster
- Duration of treatment / exposure:
- Three pIasters each animal. The first pIaster was removed after 3 minutes, the second after 1 hour and the last one after 4 hours.
- Observation period:
- 7 days
- Number of animals:
- 2 males, 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: all animals
- Time point:
- other: 24/48/72 h and /d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: all animals
- Time point:
- other: 24/48/72 h and 7d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Necrosis
- Basis:
- animal: all animals
- Time point:
- other: 24/48/72 h and 7d
- Score:
- 0
- Max. score:
- 1
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since no skin findings were seen at the administration sites and all animals behaved unobtrusively, the test substance CDBA 70 ZW, a chemical
intermediate of BIBR 1048, is considered not to be skin irritating or caustic.
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