Registration Dossier

Toxicological information

Health surveillance data

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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.
Cross-reference
Reason / purpose:
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 [cited in US FDA, 1972a].

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
Volunteers given 1000, 1500, 2000, or 2500 mg/day for 5 days each.

Results and discussion

Results:
Marked symptoms, signs of discomfort, and malaise (nausea, headache, weakness, burning and irritation of oesophagus) were reported.

Applicant's summary and conclusion