Registration Dossier

Administrative data

Endpoint:
biochemical or cellular interactions
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
The effect of Histamine H2 Receptor Antagonist on Platelet Aggregation in Man
Author:
Horton MA, Amos RJ and Jones JJ
Year:
1983
Bibliographic source:
Scand J Haematol (1983) 31, 15-19

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The in vitro effects on platelet aggregation of various imidazole (cimetidine, oxmetidine, burinamide. metiamide) and non-imidazole (ranitidine) histamine H2 receptor antagonists and structural analogues of imadazole. Platelet aggregation was studied using and ADG Intruments aggregometer. Effects were measured in vitro by preincubation of platelet rich plasma with 20 µl or test substance for 1 minute.
GLP compliance:
no
Type of method:
in vitro
Endpoint addressed:
other: Platelet aggregation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test substance (as cited in study report): 1,2-Dimethylimidazol

Test animals

Details on test animals and environmental conditions:
Platelet rich plasma (PRP) was obtained form citrated blood (1:9, citrate 3.8 %: whole blood) from 6 normal male volunteers using standard methods; all had been drug free for at least 14 days. Aggregation was induced in 200 µl of PRP by the addition of 20 µl ADP at final concentrations of 20, 10, 5, 2, 1 and 0.4 µmol/l un 5 and 20 µl of collagen suspension.

Administration / exposure

Details on study design:
- Tested dose range: 30, 250, 500, 1000 µmol/l

Results and discussion

Details on results:
The test substance showed up to the highest tested concentration of 1000 µmol/l no reduction in the aggregation rate in comparison to control.

Applicant's summary and conclusion