Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: human data
Adequacy of study:
supporting study
Study period:
not specified
Reliability:
other: not rated acc. to Klimisch
Rationale for reliability incl. deficiencies:
other: Any kind of reliability rating is not considered to be applicable, since human studies/reports are not conducted/reported according to standardised guidelines.

Data source

Reference
Reference Type:
publication
Title:
Scratch-chamber tests in food handler dermatitis
Author:
Niinimäki, A.
Year:
1987
Bibliographic source:
Contact Dermatitis 16: 11 - 20.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
60 eczema patients were treated with 2.5 % of citric acid in petrolatum using the Finn chamber method. The skin reactions were evaluated on day 4 using the criteria of The ICDRG.
GLP compliance:
not specified
Remarks:
not specified in the publication

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
not specified
Specific details on test material used for the study:
not specified

Method

Type of population:
general
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 60 patients


Clinical history:
- History of allergy or casuistics for study subject or populations/Exposure history:
The suspected cause of hand eczema in patients over 7 years was their handling of foodstuffs. All large majority of the patients were food handlers: chefs, cooks or kitchen assistants, food sellers or packers. domestic science students and domestic science school teacher. ln addition, patients with a positive patch test response to balsam of Peru were investigated. The duration of their hand eczema varied from some weeks to over 20 years. Hand eczema was the main symptom in every patient; some had or had had symptoms in other parts of the body. A few of patients had or had had atopic eczema or allergic respiratory symptoms with relevant prick test results.
Controls:
not specified
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test; Finn chamber method)

ADMINISTRATION
- Vehicle / solvent: petrolatum
- Concentrations: 2.5 % of the test item
- Testing/scoring schedule: reactions were evaluated on day 4

EXAMINATIONS
- Grading/Scoring system: criteria of the ICDRG*

*Reference:
- Cronin E. Conlact dermatitis. Edinburgh, London and New York: Churchill Livingstone, 1980, 10-11, 17.

Results and discussion

Results of examinations:
No allergic or irritant reaction was observed in the 60 eczema patients after treatment with 2.5 % citric acid in petrolatum.

Applicant's summary and conclusion

Conclusions:
According to the authors, no allergic or irritant reaction was observed in 60 eczema patients after treatment with 2.5 % citric acid in petrolatum.