Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other:
Remarks:
Basic information given. Some aspects of follow up study not clear from publication which means study can only be used as supportive information. Results not methodology considered relevant for REACH purposes.

Data source

Reference
Reference Type:
publication
Title:
Patch testing with Ethyl Alcohol.
Author:
Pitarch G, de la Cuadra J
Year:
2010
Bibliographic source:
Dermatitis 21(2) 120-1

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
Case history report and patch testing with ethanol using patient and volunteers as controls

GLP compliance:
no

Method

Type of population:
general
Ethical approval:
not applicable
Subjects:
- Number of subjects exposed: 1
- Sex: female
- Age:77
- Known diseases:degenerative osteoarthritis and vertebral fractures.
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

EXAMINATIONS
- Other: Laser doppler flowmeter

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: Erythmatous and itchy lesions at sites of patches

RESULT OF CASE REPORT: The authors concluded that such adverse effects are only likely to be seen when exposure to ethanol occurs under occluded conditions and for a prolonged period.

Applicant's summary and conclusion

Executive summary:

A patient using a transdermal drug delivery system which used ethanol as a solvent, experienced effects characterised as delayed hypersensitivity after continuous use of the system for a couple of months. The conclusion of the follow up study was that such adverse effects are only likely to be seen when exposure to ethanol occurs under occluded conditions and for a prolonged period and that evaporation under unoccluded conditions severly limits the potential for such adverse reactions.