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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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

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).