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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
other: Human observational study
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

Reference
Reference Type:
publication
Title:
Upper gastrointestinal lesions after potassium chloride supplements: a controlled clinical trial
Author:
McMahon GF, Akdamar K, Ryan JR, Ertan A
Year:
1982
Bibliographic source:
The Lancet 13. 1059-1061

Materials and methods

Type of study / information:
in vivo experiment
Endpoint addressed:
repeated dose toxicity: oral
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
the effects of a new microcapsulated potassium chloride formulation on the upper gastrointestinal tract mucosa was compared with that of a popular wax formulation in 48 volunteers
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no details given

Method

Ethical approval:
confirmed, but no further information available
Details on study design:
48 volunteers participated:
one part of the volunteers received 2 mg glycopyrrolat (to decrease gastric emtying), before they got 2.4 g KCL in two different formulations ( wax-matrix or microencapsulated), 3 times a day for 7 days; the other part of the volunteers were treated in the same manner but without glycopyrrolat
Exposure assessment:
measured

Results and discussion

Results:
gastric irritation:
In general microencapsulated KCl caused no or only slight lesions in the musous membranes of the upper gastrointestinal tract of the voluntiers
KCl in wax matrix with or without glycopyrrolate caused inflammatory lesions, erosions and gastric ulcers. Lesions occurred most commonly in the prepyloric area and/or the entire antrum of the stomach but also in distal oesophagus or duodenal bulb.

Applicant's summary and conclusion

Conclusions:
gastric irritation:
In general microencapsulated KCl caused no or only slight lesions in the musous membranes of the upper gastrointestinal tract of the voluntiers
KCl in wax matrix with or without glycopyrrolate caused inflammatory lesions, erosions and gastric ulcers. Lesions occurred most commonly in the prepyloric area and/or the entire antrum of the stomach but also in distal oesophagus or duodenal bulb.