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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
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:
1980
Bibliographic source:
Dermatosen 28, 11 - 13.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent

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 group
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 group
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 group
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 group
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.