Potassium chloride

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: the reported details are limited

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

Reference Type:

review article or handbook

Title:

Potassium chloride (CAS-Nr. 7447-40-7)

Author:

UNEP

Year:

2003

Bibliographic source:

United Nations Environmental Program

Materials and methods

Principles of method if other than guideline:

Pregnant female rats received 3.1 , 14.4, 66.8, 310.0 mg/kg bw /day from gd 6 to gd 15 by gavage. the controls were sham treated with the vehicle at a level equivalent to the group receiving the highest dose.

GLP compliance:

not specified

Limit test:

no

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

Molecular formula:

KCl

IUPAC Name:

potassium chloride

Details on test material:

no further data available

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

free access to food and water , temperature and humidity controlled quarters

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

Pregnant female mice received 2.35 , 10.9, 50.6, 235 mg/kg bw /daydissolved in water from gd 6 to gd 15 by gavage. the controls were sham treated with the vehicle at a level equivalent to the group receiving the highest dose.

Analytical verification of doses or concentrations:

not specified

Details on mating procedure:

one male was not permitted to impregnate more than one female: vaginal sperm plug: gestation day : 0

Duration of treatment / exposure:

gd 6-gd 15

Frequency of treatment:

daily

Duration of test:

until gd 20

Doses / concentrations

Remarks:

Doses / Concentrations:
3.1, 14.4, 66.8, 310.0 mg/kg bw /day
Basis:

No. of animals per sex per dose:

20-23 pregnant females

Control animals:

yes, sham-exposed

Details on study design:

Pregnant female rats received 3.1, 14.4, 66.8, 310.0 mg/kg bw /day from gd 6 to gd 15 by gavage. the controls were sham treated with the vehicle at a level equivalent to the group receiving the highest dose. Sacrifice of all dams on day 20 of gestation.

Examinations

Maternal examinations:

body weights on day 0, 6, 11, 15, 17 of gestation,
daily for appearancem behavior, , food consumption, , daily room temperature and humidity,
dams urogenital tract was examined after cesarian secrion

Ovaries and uterine content:

sex, number of corpora lutea, implantation sites , resorptions sites, live and dead fetuses

Fetal examinations:

live and dead fetuses, body weight of live pups, gross examination for the presence of external abnormalities: one third underwent visceral examinations and two third skeletal examination

Statistics:

no data

Indices:

no data

Historical control data:

no data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:
The administration of up to 235 mg/kg bw of KCl to pregnant mice for 10 consecutive days had no clearly discernible effect on nidation or on maternal survival

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

ca. 310 mg/kg bw/day (actual dose received)

Basis for effect level:

other: maternal toxicity

2

Dose descriptor:

NOAEL

Effect level:

ca. 310 mg/kg bw/day (actual dose received)

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
The administration of up to 235 mg/kg bw of KCl to pregnant mice for 10 consecutive days had no clearly discernible effect on nidation or on maternal of fetal survival. The number of abnormalities seen in either soft or skelital tissues of the test groups did not differ from the numger occurring sponateously in the sham treated controls

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Executive summary:

The administration of 3.1 up to 310.0 mg/kg bw of KCl to pregnant Wistar rats for 10 consecutive days(gd 6 -gd15, sacrifice on gd20) had no clearly discernible effect on nidation or on maternal of fetal survival. The number of abnormalities seen in either soft or skelital tissues of the test groups did not differ from the numger occurring sponateously in the sham-treated controls (FDRL 1975)