Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: case report
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment. Report on a case of human allergic contact dermatitis induced by the test substance.

Data source

Reference
Reference Type:
publication
Title:
Allergic contact dermatitis from 3-(α-methoxy)methylenebenzofuran-2(3H)-one (MBF) and α-chloro-4-fluoroacetophenone (CFAP) in chemical process workers.
Author:
Boffa MJ, Heron RJL, Wilkinson SM, Beck MH
Year:
1996
Bibliographic source:
Contact Dermatitis 34: 434-435

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
Case report on occupational sensitization to the test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): α-chloro-4-fluoroacetophenone (CFAP)
- Substance type: organic chemical intermediate
- Physical state: not reported
- Analytical purity: not reported

Method

Type of population:
occupational
Subjects:
- Number of subjects exposed: 1
- Sex: male
- Age: 44
- Race: no data
Clinical history:
- History of allergy or casuistics for study subject or populations: no data
- Symptoms, onset and progress of the disease: 18-month history of recurrent facial eczema.
- Exposure history: regular occupational handling of the test substance
- Aggravating factors both in home and workplace: no data
- Family history: not applicable
Controls:
not applicable
Route of administration:
other: dermal and inhalation possible
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: not reported
- Vehicle / solvent: toluene
- Concentrations: 0.005%
- Volume applied: not reported
- Testing/scoring schedule: readings after 2 and 4 days
- Removal of test substance: no data

EXAMINATIONS
- Grading/Scoring system: not reported

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: skin problems of patient developed only at work

RESULT OF CASE REPORT: Patient appeared to have been sensitized following occupational exposure

Applicant's summary and conclusion