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Diss Factsheets

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: Study is not done according to OECD guideline, but it is a well documented study.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Contact sensitivity to quinidine sulfate from occupational exposure.
Author:
Wahlberg, J.E. and Boman, A.
Year:
1981
Bibliographic source:
Contact Dermatitis 7(1):27-31

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
The patients were tested with the standard series and with quinidine sulfate (crystals, saturated aqueous solution, serial dilution in water: 0.5%, 0.25%, 0.125% and 0.0625%), flakes and with 1% aqueous solution of quinine hydrochloride.

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Test material form:
other: crystals, saturated aqueous solution
Details on test material:
- Name of test material (as cited in study report): sensitization is caused by working in a pharmaceutical industry where a new drug release system for quinidine sulphate had been developed. To examine sensitization a Patch test was done using quinidine sulphate.- other: obtained from ACO Läkemedek AB, Solna, Sweden

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed:1- Sex: female- Age: 26- Number of subjects exposed:1- Sex: male- Age: 27- Number of subjects exposed:1- Sex: male- Age: 52
Clinical history:
The two patiens had been working for 2 and 3 month, respectively, in the same pharmaceutical industry, when they got skin rashes on their hands, arms and face. Their task had been develop a new drug release system for quinidine sulphate and they had had intimate skin contact with crystals as well as with flakes containing the drug. All patients reacted to quinidine sulphate as crystals, in solution and as flakes in the patch test.- Exposure history: 3 month- Symptoms, onset and progress of the disease: skin rashes on hands, arms and face- Exposure history: 2 month- Symptoms, onset and progress of the disease: skin rashes on hands, arms and face- Exposure history: 2 month- Symptoms, onset and progress of the disease: skin rashes face, neck and chest
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)ADMINISTRATION- Test material: quinidine sulphate crystals, saturated aqueous solution, serial dilutions in water (0.5; 0.25; 0.125 and 0.0625 %) and flakes

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions: all three patients reacted to quinidine sulphate as crystals, in solution and as flakes.- Controls: Fifteen dermatitis patients were negative to a 0.5 % aqueous solution of quinidine sulphate.

Applicant's summary and conclusion

Conclusions:
Quinidine is a potent contact allergen. The patients became sensitized after short exposure time (2-3 month).
Executive summary:

For testing the skin sensitisation, patients expected to be sensitive to quinidine were tested with a standard patch test. All three patients reacted to quinidine sulphate as crystals, in solution and as flakes. Fifteen dermatitis patients (controls) were negative to a 0.5 % aqueous solution of quinidine sulphate. The patients became sensitized after exposure. Quinidine is a potent contact allergen.