Registration Dossier
Registration Dossier
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EC number: 212-344-0 | CAS number: 793-24-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-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 scientific 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:
- Yamano, T. et al.
- Year:
- 2 009
- Bibliographic source:
- Contact Dermatitis, 60, 193-198
Materials and methods
- Principles of method if other than guideline:
- other: Guinea pig maximization test according to Nakamura A. et al. (1994) Contact Dermatitis, 31, 72-85
- GLP compliance:
- not specified
- Remarks:
- The study is an academic publication and often the GLP status is not specified.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted before the requirement for the LLNA
Test material
- Reference substance name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- EC Number:
- 212-344-0
- EC Name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- Cas Number:
- 793-24-8
- Molecular formula:
- C18H24N2
- IUPAC Name:
- N1-(4-methylpentan-2-yl)-N4-phenylbenzene-1,4-diamine
- Details on test material:
- N-(1,3-dimethylbutyl)-N'-phenyl-p-phenylenediamine (DMBPPD)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone
- Concentration / amount:
- induction (intradermal and topical: 500 ppm, challenge: 50 ppm and 5000 ppm
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- induction (intradermal and topical: 500 ppm, challenge: 50 ppm and 5000 ppm
- No. of animals per dose:
- 4
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 ppm
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- positive skin reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 ppm. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: positive skin reaction.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5000 ppm
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- positive skin reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5000 ppm. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: positive skin reaction.
Any other information on results incl. tables
DMBPPD was positive in the guinea pig maximation test; at 50 ppm (0.005 %) and 5000 ppm (0.5%)( 4/4 treated animals showed positive skin reactions.
Potency category based on GPMT: strong
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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