Registration Dossier
Registration Dossier
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EC number: 200-578-6 | CAS number: 64-17-5
Sensitisation data (human)
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:
- 2 010
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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