Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1986
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The test substance was only used for re-challenge. Thus, results are not sufficient for assessment.

Data source

Reference
Reference Type:
publication
Title:
Sensitizing capacity of 2-methylolophenol 4-methylol phenol and 2,4,6-trimethylol phenol in the guinea pig
Author:
Bruze M
Year:
1986
Bibliographic source:
Contact Dermatitis 14, 32-38

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
see below in "principles of methods"
Principles of method if other than guideline:
GPMT was first performed with 2-methylolphenol, then re-challenge was performed with 13.1 w/w % of the test substance in ethanol. Test was performed according to Magnusson and Kligman J. Invest Dermatol. (1969), 52, 268-276.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: ethanol
Concentration / amount:
Intradermal : 5.0 % w/v: SLS: 10 % w/v; Topical 25 % w/v; Challenge (I)15 % (II) o-cresol 13.1 % w/v.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
Intradermal : 5.0 % w/v: SLS: 10 % w/v; Topical 25 % w/v; Challenge (I)15 % (II) o-cresol 13.1 % w/v.
No. of animals per dose:
No data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
2nd reading
Group:
test group
Dose level:
challenge 13.1 % w/v
Clinical observations:
Control group animals also showed skin effects, therefore the used test concentration was probably irritating.
Remarks on result:
other: Reading: 2nd reading. Group: test group. Dose level: challenge 13.1 % w/v. Clinical observations: Control group animals also showed skin effects, therefore the used test concentration was probably irritating..

Any other information on results incl. tables

The number of animals per group and the number of animals with reactions were not indicated and could only be assumed based on the similarity of the study to the OECD Guideline 406 and the results of the clinical observations: 10 animals per group; 10 animals with reactions.

Applicant's summary and conclusion