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Toxicological information

Sensitisation data (human)

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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 5 case reports.

Data source

Reference
Reference Type:
publication
Title:
Quinine Sensitivity.
Author:
Calnan, C. D. and Caron, G. A.
Year:
1961
Bibliographic source:
Br Med J. 2(5269): 1750–1752

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:
Not intended cases of contact dermatitis, proven by a patch test to result from quinine.
GLP compliance:
not specified

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:
not specified
Details on test material:
- Name of test material (as cited in study report): sensitization is caused by various quinine-containing products like e.g. contraceptive pessaries, hair-restoring lotion etc. To examine sensitization a Patch test was done using quinine sulphate.

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed:1- Sex: male- Age: 40- Number of subjects exposed:1- Sex: male- Age: 25- Number of subjects exposed:1- Sex: male- Age: 31- Number of subjects exposed:1- Sex: male- Age: 36- Number of subjects exposed:1- Sex: male- Age: 40
Clinical history:
Case 1:- Symptoms, onset and progress of the disease: rash of 10 weeks' duration on his arms, legs, and genitalia which was diagnosed clinically as lichen planus.- History of allergy: The patient gave a previous history of a contact dermatitis of the penis after his wife's use of a contraceptive pessary containing quinine. Some time later he suffered an episode of an eruption on the genitalia, palms, and soles after the ingestion of quinine.- Aggravating factors both in home and workplace: the patient's wife had used a quinine containing contraceptive pessary.Case 2:- Symptoms, onset and progress of the disease: eczematous eruption of his perineum and genitalia which had been present for two months.- Aggravating factors both in home and workplace: It started after his wife had begun using a proprietary brand of a quinine containing contraceptive pessary.Case 3:- Symptoms, onset and progress of the disease: balanitis- Aggravating factors both in home and workplace: The patient had been using a rubber condom and his wife may have been using chemical contraceptive pessaries.Case 4:- Symptoms, onset and progress of the disease: acute dermatitis of the scalp, face, neck, and left hand of two weeks' duration.- History of allergy: The patient had used a proprietary brand of quinine containing hair-restoring lotion. At the age of 22 he had had an eruption on the genitalia after his wife's use of a chemical contraceptive containing quinine. In 1958 he again developed an acute dermatitis of the face and hands. This had begun on the day after he had had a tooth extracted, and, although none of the materials used by his dentist contained quinine, it is possible that the patient had taken a quinine-containing analgesic tablet.Case 5:- Symptoms, onset and progress of the disease: generalized itching, macular, erythematous eruption- History of allergy: In childhood the patient had developed a scarlet-fever-like rash after taking a tonic", he was subsequently told that he was sensitive to quinine. When aged 34 he had an acute dermatitis of the scalp after using a proprietary hair lotion (presumed to have contained quinine)
Route of administration:
dermal
Details on study design:
Case 1-4:TYPE OF TEST(S) USED: patch test (epicutaneous test)ADMINISTRATION- Vehicle / solvent: water- Test material: 2 % solution of quinine sulphate- Controls: only in Case 2 - 0.1 % mercuric chloride and ammoniated mercuryCase 5:TYPE OF TEST(S) USED: patch test as well as scratch and intradermal testADMINISTRATION- Test material: 1 % solution of quinine sulphate

Results and discussion

Results of examinations:
Case 1:SYMPTOMS- duration of symptoms observed: 10 weeks' durationNO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions:1RESULT OF CASE REPORT:The patient gave a previous history of a contact dermatitis of the penis after his wife's use of a contraceptive pessary containing quinine. Some time later he suffered an episode of an eruption on the genitalia, palms, and soles after the ingestion of quinine. His general practitioner suspected that the presenting rash was also due to quinine sensitivity, since it seemed to have begun after the patient's wife had again used a quinine containing contraceptive pessary. A patch test to a 2% solution of quinine sulphate was positive after 48 hours.Case 2:SYMPTOMS- duration of symptoms observed: 2 month durationNO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions:1RESULT OF CASE REPORT:A 25-year-old man with an eczematous eruption of his perineum and genitalia which had been present for two months; it started after his wife had begun using a proprietary brand of a quinine containing contraceptive pessary. Patch tests to the pessary and to a 2% solution of quinine sulphate were positive. Tests with 0.1 % mercuric chloride and ammoniated mercury ointment were negative.Case 3:NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions:1RESULT OF CASE REPORT:A man aged 31 was referred in 1957 by his general practitioner as a case of balanitis, possibly due to contact dermatitis. He had been using a rubber condom. Positive patch tests were obtained with a piece of rubber from the condom, a quinine-containing pessary, and a 2% solution of quinine sulphate.Case 4:SYMPTOMS- duration of symptoms observed: 2 week´s durationNO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions:1RESULT OF CASE REPORT:A man aged 36 was first seen in May, 1953, with an acute dermatitis of the scalp, face, neck, and left hand of two weeks' duration. This had started on his bald scalp the day after he had used a proprietary brand of quinine containing hair-restoring lotion. On this occasion a patch test with 2% quinin sulphate was positive. Case 5:NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions:1RESULT OF CASE REPORT:A man aged 40 was seen in March, 1961, with a generalized itching, macular, erythematous eruption. He had recently had an entirely similar episode. His previous history was that in childhood he had developed a scarlet-fever-like rash after taking a tonic", he was subsequently told that he was sensitive to quinine. When aged 34 he had an acute dermatitis of the scalp after using a proprietary hair lotion (presumed to have contained quinine). Skin tests were done with 1 % quinine sulphate in normal saline. The scratch and intradermal tests gave negative immediate-type reactions, but the patch test was strongly positive after 72 hours.

Applicant's summary and conclusion

Conclusions:
Quinine is a potent contact sensitizer. In these five case reports, all patients became sensitized after exposure.
Executive summary:

Five patients expected to be sensitive to quinine were tested with a standard patch test. All five patients reacted to a 2% (4 patients) or 1% (1 patient) solution of quinine sulphate. The patients became sensitized after exposure. Quinine is a contact allergen.