Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 235-227-6 | CAS number: 12136-45-7
Additional toxicological data
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:
- 1 988
- 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:
- 1 982
- 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:
- 1 977
- 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:
- 1 984
- 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 substance name:
- Potassium chloride
- EC Number:
- 231-211-8
- EC Name:
- Potassium chloride
- Cas Number:
- 7447-40-7
- IUPAC Name:
- potassium chloride
Constituent 1
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.
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.
