Registration Dossier
Registration Dossier
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EC number: 202-969-7 | CAS number: 101-72-4
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: publication meets generally accepted scientific principles, without detailed documentation, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Occupational eczema from N-isopropyl-N' phenylparaphenylenediamine (IPPD) and N-dimethyl-1,3 butyl-N'-phenylparaphenylenediamine (DMPPD) in tyres.
- Author:
- Herve-Bazin B, Gradiski D, Duprat P, Marignac B, Foussereau J, Chevalier C, Bieber P
- Year:
- 1 977
- Bibliographic source:
- Contact Dermatitis 3: 1-15
Materials and methods
- Principles of method if other than guideline:
- Method: other: according to Magnusson & Kligman (1969)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Published study. The guinea pig maximisation test was conducted in the year 1977 or before (GPMT, Herve, 1977). At this time point a no reliable guideline was available for the conduction of a LLNA.
Test material
- Reference substance name:
- N-isopropyl-N'-phenyl-p-phenylenediamine
- EC Number:
- 202-969-7
- EC Name:
- N-isopropyl-N'-phenyl-p-phenylenediamine
- Cas Number:
- 101-72-4
- Molecular formula:
- C15H18N2
- IUPAC Name:
- N1-phenyl-N4-(propan-2-yl)benzene-1,4-diamine
- Details on test material:
- IPPD
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: 1% vaseline
- Concentration / amount:
- induction (intradermal: 0.5 % in olive oil, epicutaneous: 1% vaseline),
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- other: 1% vaseline
- Concentration / amount:
- induction (intradermal: 0.5 % in olive oil, epicutaneous: 1% vaseline),
- No. of animals per dose:
- 20
- Details on study design:
- 1st application: Induction 0.5 % intracutaneous
2nd application: Challenge 0.05 % open epicutaneous
3rd application: Challenge 0.5 % open epicutaneous
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.05%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.05 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: no data.
Any other information on results incl. tables
TS concentration % sensitization sensitizing potential
0.05 % TS 10 % low
0.5 % TS 90 % high
controls 0 % -
Potency categorisation based on GPMT:strong
-Clinical signs: not reported
The authors also noted a cross-sensitization to
N-phenyl-N'-cyclohexyl-p-phenylenediamine (CPPD): 90 % of animals sensitized to
IPPD showed cross-sensitization to 0.05 % CPPD in vaseline. Animals sensitized
to p-phenylenediamine (PPD) or to N-dimethyl-1,3butyl-N'-phenyl-paraphenylenediamine
(6PPD) showed also cross-sensitization to IPPD (see table).
Table: Cross-Sensitization in guinea pigs (% animals cross-sensitized)
Cross-reaction product tested (0.05 % in vaseline):
Sensitizer: CPPD 6PPD PPD IPPD
CPPD 50 5 15 nd
6PPD 30 50 nd nd
PPD 100 95 80 95
IPPD 90 85 100 10
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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