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Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication, meets generally accepted scientific principles.

Data source

Reference
Reference Type:
publication
Title:
The most frequent contact allergens of the years 2007 to 2009 - Current data of the Information Network of Departments of Dermatology
Author:
Geier J, Uter W, Krautheim A, Lessmann, H, Schnuch, A
Year:
2011
Bibliographic source:
Allergo-J 20: 93-101 [article in German]

Materials and methods

Study type:
case control study (retrospective)
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
Epidemiological surveilance of contact sensitization with presentation of the most frequent contact allergens.
Analysis of data of the Information Network of Departments of Dermatology (IVDK) of the years 2007 to 2009.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: patients
Ethical approval:
not specified
Details on study design:
patch testing
Statistical methods:
Statistical analysis of data of the Information Network of Departments of Dermatology (IVDK) of the years 2007 to 2009. Patch test reactions assessed on day 3 (or day 4) were evaluated.
For the evaluation of test results, a statistical analysis was performed according to the guidelines for the descriptive presentation and statistaical of contact allergy data by means of the software package SAS 9.1 (SAS Institute, Cary NC, U.S.A.).

Results and discussion

Results:
Bronopol - Relative response rate in % (95% coincidence interval)
Women (n = 21.250): 1.3 (1.2 - 1.5),
Men (n = 12841): 1.6 (1.4 - 1.9)

During the study period, 34,091 patients havc been patch tested in the departments of dermatology forming the IVDK. Compared to the years before, reactions tonickel sulphate, cobalt chloride and potassium dichromate were significantly less frequent in 2009 than before. The preservative methyldibromo glutaronitrile(MDBGN) elicited signitlcantly less positive reactions already from 2008 on. The proportion of positive reactions to the fragrance hydroxyisohexyl 3-cydohexene carboxaldehyde (HICC, LYRAL) was considerably, albeit not significantly, lower in 2009, when compared to 2007and 2008. Sensitization frequency to bufexamac has been at a constant level for years.

Applicant's summary and conclusion