Registration Dossier
Registration Dossier
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EC number: 235-227-6 | CAS number: 12136-45-7
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- other: Human observational study
- Adequacy of study:
- key 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:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
- Study type:
- medical screening
- Endpoint addressed:
- basic toxicokinetics
- repeated dose toxicity: oral
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Type: other:Repeated Dose Toxicity
44 females aged 18-55 years were selected for the study on the basis of lower prevailing potassium intake.
They were randomly allocated to one of two groups who took either 80 mmol/day of KCl (Slow-K, Ciba Geigy), or matching placebo for the first two 4-week treatment periods.
The treatments were reversed during the second 4-week period. Blood pressure, heart rate, urinary volume, electrolytes and creatinine, were measured weekly during a screening period and the two 4-weeks treatment periods. - 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
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- 44 females aged 18-55 years were selected for the study on the basis of lower prevailing potassium intake.
They were randomly allocated to one of two groups who took either 80 mmol/day of KCl (Slow-K, Ciba Geigy), or matching placebo for the first two 4-week treatment periods.
The treatments were reversed during the second 4-week period. Blood pressure, heart rate, urinary volume, electrolytes and creatinine, were measured weekly during a screening period and the two 4-weeks treatment periods.
Results and discussion
- Results:
- NOAEL > 85 mg/kg body weight.
No significant changes in blood pressure or heart rate. Significant increases in potassium urinary excretion (P<0.001) and plasma potassium level
(equivalent to 0.2 mmol/l; P<0.007).
Applicant's summary and conclusion
- Conclusions:
- NOAEL > 85 mg/kg body weight.
No significant changes in blood pressure or heart rate. Significant increases in potassium urinary excretion (P<0.001) and plasma potassium level
(equivalent to 0.2 mmol/l; P<0.007).
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