Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficient details available to make a reliability assessment, reference could not be made available
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Influence of benzoic acid and benzoates on digestion and health.
Author:
Wiley HM, Bigelow WD
Year:
1908
Bibliographic source:
Bulletin 84, Part IV. Bureau of Chemistry, US Department of Agriculture

Materials and methods

Principles of method if other than guideline:
Method not determined: reference not located

Test material

Constituent 1
Chemical structure
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

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
In a study with volunteers given 1000, 1500, 2000, or 2500 mg/day for 5 days each.

Results and discussion

Results:
At dose 1000, 1500, 2000, or 2500 mg/day, marked symptoms, signs of discomfort, and malaise (nausea, headache, weakness, burning and irritation of oesophagus) were reported.

Applicant's summary and conclusion