Registration Dossier
Registration Dossier
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EC number: 204-616-2 | CAS number: 123-30-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedures based on scientific principles and standards, limited documentation, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US Consumer Product Safety Commission (Code of Federal Regulations, Title 16, Section1500.41)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-aminophenol
- EC Number:
- 204-616-2
- EC Name:
- 4-aminophenol
- Cas Number:
- 123-30-8
- Molecular formula:
- C6H7NO
- IUPAC Name:
- 4-aminophenol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- other: 0.5% aqueous gum tragacanth, containing 0.05% anhydrous sodium sulphite (Na2SO3)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 2.5%(w/v)suspension - Number of animals:
- 3 rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: primary irritation index
- Score:
- 0.2
- Remarks on result:
- other: mildly irritant
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: data provided as primary index value
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: data provided as primary index value
- Irritant / corrosive response data:
- The treatment led to slight edema of both the intact and abraded site in one rabbit at 24hr after application indicating very mild skin irritancy.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 4-aminophenol was slightly irritant to rabbit skin based on US Consumer Product Safety Commission criteria.
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