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Toxicological information

Skin sensitisation

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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:
1977
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
Name:
Unnamed
Type:
Constituent
Details on test material:
IPPD

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 group
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 group
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