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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
other: Published data
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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further data available

Test animals

Species:
rat
Strain:
Wistar
Details on test animals 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
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 310 mg/kg bw of KCl to pregnant rats for 10 consecutive days had no clearly discernible effect on nidation or on maternal survival

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
ca. 310 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
ca. 310 mg/kg bw/day (actual dose received)
Based on:
test mat.
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 310 mg/kg bw of KCl to pregnant rats 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

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
310 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Embryotoxic / teratogenic effects:no effects

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
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 .
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 .