Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

unsuitable test system

Data source

Reference

Reference Type:

publication

Title:

Occupational Allergy in Medical Doctors

Author:

Sato K., Kusaka Y., Suganuma N., Nagasawa S., Deguchi Y.

Year:

2004

Bibliographic source:

Journal of Occupational Health 2004; 46: 165–170

Materials and methods

Study type:

cross sectional study

Endpoint addressed:

skin sensitisation

Principles of method if other than guideline:

The factors relating to occupational allergy in doctors were investigated using self-administered questionnaires.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

EC Number:

913-404-5

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

Details on test material:

- Purity: ≥ 92%- pH: ≥ 1 - ≤ 5 (aqueous preparation)

Specific details on test material used for the study:

- Name of the test material: Povidone Iodine

Method

Type of population:

occupational

Ethical approval:

not applicable

Details on study design:

METHOD OF DATA COLLECTION - Type: Questionnaire - Details: The self-administered questionnaire consisted of inquiries regarding present departments within hospitals and clinics, allergic diseases, family histories, occupational allergy in hospital environments, relevant allergenic agents and substances, life-styles i.e. smoking, physical exercise. STUDY PERIOD: - Selfadministered questionnaire studies were performed in March, 1994 for subjects in Fukui Prefecture and in April 1996 for subjects outside Fukui Prefecture.STUDY POPULATION - The subjects were 895 doctors who had graduated from School of Medicine, Fukui Medical University between 1986 and 1995. Two-hundred and fifty-three had graduated between 1986 and 1993 and were living in Fukui Prefecture at the time of this study. Six-hundred and fourty-two had graduated between 1986 and 1995 and were living outside Fukui Prefecture.CRITERIA- Since the present subjects were qualified doctors, their responses to these items were considered to be valid. The criteria for past and family history of bronchial asthma, allergic rhinitis, sinusitis, eczema, urticaria, allergic conjunctivitis and atopic dermatitis were as follows: In cases positive for one of these items concerning a past or family history in the questionnaire, the subjects were considered to have that condition. A past history of allergic diseases was regarded as present before starting medical practices. When they stated that they had at least one family member who suffered from a corresponding allergic disease, they were considered to have a family history of the allergic disease. - Occupational allergy was defined as follows: Any allergic disease including rhinitis, dermatitis, asthma and conjunctivitis induced by a medicine or handling a laboratory animal in a hospital or at an experimental facility within a medical school; if a responder indicated positiveness to a corresponding item, the responder chose the name of the allergen from the list of allergenic medicines and laboratory animals enrolled in the questionnaire. If there were no relevant allergens listed, he or she wrote down the name of the allergen in the questionnaire space.RESPONSE RATE- Response rate to the questionnaires in doctors who were living in Fukui Prefecture was 37.9% (96/253), and that of those outside Fukui Prefecture was 32.9% (211/642). The overall response rate was 34.3% (307/895).- 307 doctors were analyzed in this study, 241males and 66 females. The mean age was 30.8 ± 4.2 year (mean ± S.D.).

Exposure assessment:

not specified

Remarks:

self reported exposure

Details on exposure:

Because the subjects were physicians, they were considered to be able exactly to indicate their allergic past or present history and their etiologic factors.

Statistical methods:

The data were analyzed for univariate by the Chi-square test with Yates’ correction for professions (Surgeon or Internist), for past history of allergic disease (bronchial asthma, allergic rhinitis, atopic dermatitis or sinusitis), for lifestyle factors, i.e., smoking and physical exercise. Thereafter, a logistic regression analysis of any occupational allergy was performed for identify risk factors by using SPSS 9.0J. The covariates included in the model were gender (male=1, female=0), age (≥30=1, <30=0), past histories of any allergic diseases (yes=1, no=0), smoking (current smoker=1, non- or ex-smoker=0) and professions (“internist”=0, “surgeon”=1). Significance was accepted at p<0.05.

Results and discussion

Results:

89 out of 307 reported the presence of occupational allergy. The number of doctors reporting contact dermatitis was the largest: 77 (25.1%) followed by Allergic Rhinitis: 19 (6.2%), and Bronchial Asthma: 3 (1.0%). The most prevalent inducer was the surgical rubber glove (54 doctors); the second potential inducers were chlorhexidine gluconate (23 doctors), povidone iodine (17 doctors), ethanol (15 doctors), and laboratory animals. Past histories of allergic diseases (bronchial asthma, allergic rhinitis, atopic dermatitis or sinusitis) were significantly associated with occupational allergy in doctors. Neither smoking nor physical exercise was associated with occupational allergies.

Strengths and weaknesses:

The response rate in the mailed questionnaire study was quite low. The overall response was 34.3% (307/895). The judgement of ‘Occupational allergy in doctors’ might be biased for self-administered questionnaires and identification on allergen is also only reported via the self-administered questionnaires.