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Toxicological information

Health surveillance data

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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:
1986

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
Name:
Unnamed
Type:
Constituent

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).