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: Secondary literature source

Data source

Reference
Reference Type:
secondary source
Title:
Pharmacological Studies on Oral Hypoglycaemia Agent.
Author:
Stewart GA
Year:
1962
Bibliographic source:
Anglo-Germ.Med.Rev.1:334

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Human study looking at the effect on a volunteer given 3 g of Phenylacetic acid.
GLP compliance:
not specified

Test material

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

Method

Ethical approval:
not specified
Details on study design:
No data

Results and discussion

Results:
When given orally in single doses of 3 g to non-diabetic man no reduction in blood sugar was observed over a period of 5 hours.

Phenylacetic acid administered orally to fasted normal guinea pigs in doses of 0.375, 0.5 and 0.75 g/kg produced a reduction in blood sugar of 13, 44 and 60% of the initial values respectively in 2 to 4 hours.

When given orally in single doses of 3 g to non-diabetic man no reduction in blood sugar was observed over a period of 5 hours. This was thought that this lack of effect was due to too small a dose been administered since if man were only as sensitive as the guinea pig the hypoglycaemia dose would be about 30g.

Applicant's summary and conclusion

Conclusions:
No overt adverse effects were apparaently seen in a volunteer given 3 g of Phenylacetic acid.