Sodium benzoate

Sensitisation data (human)

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

Test material information

Constituent 1

Reference substance name:

Sodium benzoate

EC Number:

208-534-8

EC Name:

Sodium benzoate

Cas Number:

532-32-1

Molecular formula:

C7H6O2.Na

IUPAC Name:

sodium benzoate

Constituent 2

Reference substance name:

Benzoic acid, sodium salt

IUPAC Name:

Benzoic acid, sodium salt

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%).