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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Alcohol dermatitis
Author:
Fregert S, Groth O, Hjorth N, Magnusson B, Rorsman H and Ovrum P
Year:
1969
Bibliographic source:
Acta Dermato-Venereologica, , 49, 493-497
Reference Type:
secondary source
Title:
No information
Author:
RIFM
Year:
2009
Bibliographic source:
RIFM database

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Patch test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Purity unknown - of a grade commercially available for laboratories

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 4
- Sex: female
- Age: 48 - 60 years
Clinical history:
- History of allergy or casuistics for study subject or populations: dermatitis, positive reaction to ethanol
- Other: 1 of the 4 patients was originally reported in another study (Haxthausen, 1944). The patient was retested in this study.
Controls:
other alcohols
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: A1-test units (Magnusson, 1965)
- Vehicle / solvent: water
- Concentrations: 1, 10%
- Testing/scoring schedule: 48 h application; reading after removal and 24 and 48 h thereafter


EXAMINATIONS
- Grading/Scoring system: The reaction was considered to be positive if erythema as well as infiltration and/or papules-vesicles were present

Results and discussion

Results of examinations:
RESULT OF CASE REPORT:
All four patients reacted to all tested primary alcohols: methanol, ethanol, propanol, butanol, and pentanol.
All reacted to 10% solutions. Several also showed positive reactions to 1% solutions of the primary alcohols, but no numbers are given.
From the patients history, sensitization was likely caused by ethanol. For two patients, allergies to several other substances are described.

Applicant's summary and conclusion