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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 943-689-1 | CAS number: -
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Approach to Hyperkalemia
- Author:
- Lim, S.
- Year:
- 2 007
- Bibliographic source:
- Acta Med Indones-Indones J Intern Med., Vol 39, Number 2, April - June 2007; pp. 99-103.
Materials and methods
- Type of study / information:
- Cliconical parctice aboute use of Calcium gluconate.
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Treatment of hyperkalemia is dercibed.
- GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): calcium gluconate.
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- 10 mL of 10% Calcium gluconate is used by treatment of severe hyperkalemia.
- Executive summary:
"Hyperkalemia is commonly found in hospitalized patients. Given the fact that untreated hyperkalemia is associated with high morbidity and mortality, it is critical to recognize and treat this disorder promptly. Patients at greatest risk for hyperkalemia include those with diabetes or impaired renal function, those with advanced age and those receiving drugs which interfere with renal potassium excretion. Hyperkalemia is likely to become an even more common clinical event, since ACE inhibitors, angiotensin-receptor blockers and aldosterone antagonists are increasingly being used in higher doses and in combination, in the belief that these measures provide additional cardiovascular and renal protection. The urgency of hyperkalemia treatment is dictated by the change in electrocardiogram. Treatment of hyperkalemia includes calcium gluconate, insulin, beta agonists, sodium bicarbonate, cation exchange resin, diuretics and/or dialysis".
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.
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