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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: LgE was used as marker, placebo controls were included, limited data to allow definite conclusions.

Data source

Reference
Reference Type:
publication
Title:
Sodium benzoateinduced repeated episodes of acute urticaria/angiooedema: randomized controlled trial
Author:
Nettis E., Colanardi M. C., Ferrannini A. and Tursi A.
Year:
2004
Bibliographic source:
British Journal of Dermatology, 151: 898– 902

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:
A total of 47 subjects were enrolled in the study: 29 (62%) subjects were female and 18 (38%) male. Tests for IgE for common inhalant allergens and food allergens, and a double-blind, placebo-controlled challenge with the test substance. The test substance was given at increasing dosage: 25 mg, 50 mg and 100 mg.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No data given

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
This was a retrospective study based on the analysis of data from patients reported to have experienced episodes of urticaria, with or without angio-oedema, after ingesting meals or products containing the test substance. At the first visit to the outpatients clinic, a careful history was taken. Patients were then given the following diagnostic tests: tests for IgE for common inhalant allergens and food allergens, and a double-blind, placebo-controlled challenge with the test substance.

Results and discussion

Results of examinations:
A total of 47 subjects were enrolled in the study; five (11%) showed at least one relevant positive reaction to an IgE test for food allergy. Only one subject (2%) had a reaction after the ingestion of 75 mg of the test substance without an adverse reaction to placebo.

Applicant's summary and conclusion

Conclusions:
This study shows that the percentage of repeated episodes of acute urticaria/angio-oedema reactions induced by the test substance is very low (2%).
Executive summary:

A total of 47 subjects were enrolled in the study: 29 (62%) subjects were female and 18 (38%) male. Tests for IgE for common inhalant allergens and food allergens, and a double-blind, placebo-controlled challenge with the test substance. The test substance was given at increasing dosage: 25 mg, 50 mg and 100 mg. This study shows that the percentage of repeated episodes of acute urticaria/angio-oedema reactions induced by the test substance is very low (2%).