Registration Dossier
Registration Dossier
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EC number: 204-616-2 | CAS number: 123-30-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- 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:
- Allergenicity of Aminobenzene Compounds: Structure/Function Relationships.
- Author:
- Kleniewska, D. and Maibach, H.
- Year:
- 1 980
- Bibliographic source:
- Dermatosen 28, 11 - 13.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Test procedures based on scientific principles and standards, limited documentation, acceptable for assessment.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300 - 400 g
- Diet (e.g. ad libitum): ad libitum, and received lettuce weekly.
- Water (e.g. ad libitum):ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.1, 0.5, 1, 2%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.1, 0.5, 1, 2%
- No. of animals per dose:
- 10 animals per dose
- Details on study design:
- A. INDUCTION EXPOSURE
- Site: flank (over the scapula)
- Frequency of applications and Duration: four 24hr occlusive patches on alternate days
- Concentrations: 2%
B. CHALLENGE EXPOSURE
- Day(s) of challenge: After 14 days
- Site: flank (opposite)
- Concentrations: 0.1, 0.5, 1.0, 2%
- Evaluation (hr after challenge): 24, 48, 72hr - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Reading:
- other: no positive control group included
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- other: negative control group included
- Group:
- negative control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- 4-aminophenol was a skin sensitiser in the guinea pig.
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