Dipotassium oxide

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:

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

Test material information

Constituent 1

Reference substance name:

Potassium chloride

EC Number:

231-211-8

EC Name:

Potassium chloride

Cas Number:

7447-40-7

IUPAC Name:

potassium chloride

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).