Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
"Ethnic contact urticaria to alcohol
Author:
Wilkin, J.K. and Fortner G.
Year:
1985
Bibliographic source:
Contact Dermatitis : Environmental and Occupational Dermatitis, Vol . 112, pp. 118-120; cited in OECD SIDS "Isobutanol", Final September 2004

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: Asian subjects who previously had reported severe facial flushing in response to oral ethanol ingestion
Principles of method if other than guideline:
Patch test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 3
- Demographic information: asian
Clinical history:
- History of allergy or casuistics for study subject or populations: severe facial flushing in response to oral ethanol ingestion
Controls:
Ethanol was used as a positive control agent
Route of administration:
dermal
Details on study design:
The skin was rated for the presence or absence of erythema immediately post-exposure.

Results and discussion

Results of examinations:
Dermal isobutanol exposure did not cause erythema in any of the test subjects. Ethanol was positive for erythema in these same test subjects.

Applicant's summary and conclusion