Registration Dossier
Registration Dossier
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EC number: 202-951-9 | CAS number: 101-54-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable, well-documented publication which meets basic sientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Skin sensitization potency and cross-reactivity of p-phenylenediamine and its derivatives evaluated by non-radioactive murine local lymph node assay and guinea-pig maximization test
- Author:
- Yamado, T. et al.
- Year:
- 2 009
- Bibliographic source:
- Contact Dermatitis 60, 193-198
Materials and methods
- Principles of method if other than guideline:
- other: non-radioactive Mouse local lymphnode assay (LLNA) method according to Yamano et al (2003) Toxicology 190, 259-266
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-(4-aminophenyl)aniline
- EC Number:
- 202-951-9
- EC Name:
- N-(4-aminophenyl)aniline
- Cas Number:
- 101-54-2
- Molecular formula:
- C12H12N2
- IUPAC Name:
- N1-phenylbenzene-1,4-diamine
- Details on test material:
- purchased from Tokyo Kasei Co. Ltd.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Concentration:
- 0, 0.01, 0.03, 0.1, 0.3%
- No. of animals per dose:
- 4 per per group
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: 1, 1.1, 1.68*, 1.82*, 2.25** at 0%, 0.01%, 0.03%, 0.1% and 0.3% respectively (significant different from control:* p<0.05, ** p<0.01)
Any other information on results incl. tables
The test substance was a potent sensitizer in the LLNA with a minimum induction dose of 0.03%
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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