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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Patch testing with preservatives, antimicrobials and industrial biocides . Results from a multicentre study.
Author:
Schnuch A, Geier J, Uter W, Frosch PJ
Year:
1998
Bibliographic source:
British Journal of Dermatology ; 138: 467-476.

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
An appropriate epidemiological surveillance system on contact allergies, the Information Network of Departments of Dermatology (IVDK), has been established in Germany. In this study, data on preservative sensitizations collected by the system are presented and discussed, to include analysis of time trends and of subpopulations at risk.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: general population with suspected contact dermatitis
Subjects:
1787 patients were observed (76% male, 24% female; 55% <40 years).
In 46% a occupational cause was suspected.
About 1/3 of the patients were mechanics, toolmakers, engineers or metal workers. But also housewives, office workers or patients with undetermined exposure were part of the study.
Clinical history:
Records contain patients' history (e .g. occupational background, suspected allergen exposure), personal data (age, sex, geographical origin), clinical data (present skin disease(s), present or past atopic diseases) and patch test results together with a judgement on their relevance.
Route of administration:
dermal
Details on study design:
Patch tests were performed according to recommendations of the International Contact Dermatitis Research Group and the German Contact Dermatitis Group. Finn Chambers on Scan-por were used in 19 departments, and other systems (Leukotest, Hal, Curatest, Haye; Intradex Service BV, Alphenaanden Riyn, The Netherlands) were used in five departments . The test substances were delivered by Hermal/Reinbek (Germany). Nine of 24 centres applied patch tests for 24 h, the remainder (15 of 24) for 48 h . Readings were done until at least 72 h after application of the test chambers. For this study, only readings at 72 h were considered.

Results and discussion

Results of examinations:
1772 patients were investigated. 10 showed a questionable or irritative reaction. 17 showed a positive reaction (about 1% of patients).

Applicant's summary and conclusion