Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
other: Published data
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Gastric irritating effect of potassium chloride formulations.
Author:
Hutcheon, D.F., Skinhøj, A. Andersen, F.J.
Year:
1988
Bibliographic source:
Current Therap. Res. 43(1): 55-60.
Reference Type:
publication
Title:
Upper gastrointestinal lesions after potassium chloride supplements: A controlled clinical trial.
Author:
McMahon, F.G., Ryan, J.R., Akdamar, K., Ertan, A.,
Year:
1982
Bibliographic source:
Lancet Nov. 13:1059-1061.
Reference Type:
publication
Title:
Endoscopic comparison of solid and liquid potassium chloride supplements.
Author:
Patterson, D.J., Winstein, G.S., Jeffries, G.H.
Year:
1977
Bibliographic source:
Lancet Nov. 5:1077-1078.
Reference Type:
publication
Title:
Mucosal irritant potential of a potassium-sparing diuretic and of wax-matrix potassium chloride.
Author:
Ryan, J.R., McMahon, F.G., Akdamar, K., Ertan, A., Agrawal, N.
Year:
1984
Bibliographic source:
Clin. Pharmac. Ther. 35:90-93.

Materials and methods

Type of study / information:
Gastric irritating effects in humans.
Principles of method if other than guideline:
KCl administrated orally to groups of 48 to 110 volunteers in doses ranging from about 31-124 mg/kg body weight/day in either a wax or micro-encapsuled formulation for 7 days produced irritant effects in the stomach or small intestine.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

More severe effects, inflammatory lesions and gastric ulcers were seen particularly in volunteers receiving the wax formulations. 60 to 70 % of the volunteers treated with the wax-matrix KCl developed some type of gastric lesions. The lesionswere graded from 0 (nomucosal damage) to 5 (severe mucosal damage. The mean score for the control group was 0.267, and for the group receiving wax-matrix KCl 2.267.   

Applicant's summary and conclusion

Conclusions:
KCl administrated orally to groups of 48 to 110 volunteers in doses ranging from about 31-124 mg/kg body weight/day in either a wax or micro-encapsuled formulation for 7 days produced irritant effects in the stomach or small intestine.