Registration Dossier
Registration Dossier
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EC number: 251-607-4 | CAS number: 33629-47-9
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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- EC Number:
- 251-607-4
- EC Name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- Cas Number:
- 33629-47-9
- Molecular formula:
- C14H21N3O4
- IUPAC Name:
- N-sec-butyl-4-tert-butyl-2,6-dinitroaniline
- Reference substance name:
- Xylene
- EC Number:
- 215-535-7
- EC Name:
- Xylene
- Cas Number:
- 1330-20-7
- Molecular formula:
- C8H10
- IUPAC Name:
- m-xylene
Constituent 1
impurity 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 72 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 6
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article does not appear to possess irritation potential.
- Executive summary:
Six rabbits were dermally exposed to 0.5g of the test article. The skin test sites were scored for skin lesions at 1, 24, 48, 72 hours after removal of the test article patch covering. The test article produced no irritation and the Primary Irritation Index was 0. Under the conditions of the present study, the test article does not appear to possess irritation potential.
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