Registration Dossier
Registration Dossier
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EC number: 231-211-8 | CAS number: 7447-40-7
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
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
- 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
- Molecular formula:
- KCl
- IUPAC Name:
- potassium chloride
- Details on test material:
- no details given
Constituent 1
Method
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
