Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comprehension of case reports.

Data source

Reference
Reference Type:
publication
Title:
Quinine dermatitis: Investigation of a factory outbreak.
Author:
Hardie, R. A., Savin, J. A., White, D. A. and Pumford, S.
Year:
1978
Bibliographic source:
Contact Dermatitis 4(3):121-4

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Case report, investigations on an outbrek of reaction to quinine among workers of a quinine production site. Patch testing was performed for 12 of the 15 patients with suspected quinine or quinidine-induced dermatitis. The patch test were performed using quinine dihydrochloride aqueous solution.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): quinine dihydrochloride

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 15
- other: wokplace exposure to quinine and quinidine

Clinical history:
Clinical history of the severely effected patient (see results).
- Symptoms, onset and progress of the disease: severe eruption on the face, fierce photosensitive eczema on the face and back of hands
- Exposure history: Patient was employed as works chemist and exposed both to quinine products and to bromine used in the ephedrine process. About 3 weeks after investigation a bromine leakage, with possible skin contact, he noticed a serve eruption on the face. His skin cleared while on holiday but relapsed on return to work.
Route of administration:
dermal
Details on study design:
15 of 23 workers suggested that the skin eruption had been work-related. Quinine was held to be responsible by 13 workers, quinidine by one, and both quinine and quinidine by one. A patch-test was performed with these 15 patients..

ADMINISTRATION
- Test material: quinine dihydrochloride
- Concentrations: 1 %, 0.1 % and 0.01 % aqueous quinine dihydrochloride

Results and discussion

Results of examinations:
For one patient patch tests with quinine dihydrochloride in aqueous solution were initially positive at 1 %, 0.1 % and 0.01 %, but on retesting recently have now become negative. Photo patch test were positive at 1% and 0.1 % quinine dihydrochloride.

Case:
- Sex: male
- Age: 48

Applicant's summary and conclusion

Conclusions:
In the one case the patch test was positive for 1%, 0.1% and 0.01% quinine dihydrochloride. Thus, quinine dihydrochloride can be considered a contact sensitizer.
Executive summary:

In this case report 15 of 23 workers suggested that the skin eruption had been work-related. In a patch-test 12 of these 15 patients suspected to be sensitized to quinine or quinidine only one positive patch test were obtained for quinine dihydrochloride. In the case the patch test was strongly positive for 1%, 0.1% and 0.01% quinine dihydrochloride. Photo patch test were positive at 1% and 0.1 % quinine dihydrochloride. Thus, quinine dihydrochloride can be considered a contact sensitizer.