Registration Dossier
Registration Dossier
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EC number: 235-227-6 | CAS number: 12136-45-7
Exposure related observations in humans: other data
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:
- 1 982
- 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 substance name:
- Potassium chloride
- EC Number:
- 231-211-8
- EC Name:
- Potassium chloride
- Cas Number:
- 7447-40-7
- IUPAC Name:
- potassium chloride
- Details on test material:
- no details given
Constituent 1
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.
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