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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: only females used

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The acute oral toxicity of potassium chloride
Author:
Boyd EM, Shanas MN
Year:
1961
Bibliographic source:
Arch INt Pharmarodyn. 313, 275-283
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:
single oral application of different doses dissolved in water were given by gavage and animals were observed for clinical signs and mortality followed by autopsy upon non-survivors and of survivors 14 days after dosing
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
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 details given

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: 16 h
- Housing: indiviually in metabolism cages
- Diet ad libitum
- Water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Each dose was dissolved in water an given in a volume of 20 ml/kg bw
Doses:
0, 2100, 2400, 2700, 3300, 3600, 3900 mg/kg bw
No. of animals per sex per dose:
a total of 109 female mice were used (details not given)
Control animals:
yes
Details on study design:
single oral application of different doses dissolved in water were given by gavage and amimals were observed for clinical signs and mortality followed by autopsy upon non-survivors and of survivors 14 days after dosing. Each dose was dissolved in water an given in a volume of 20 ml/kg bw
Statistics:
t tests of significance of differences between means after the methods of Croxton

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 3 020 mg/kg bw
Remarks on result:
other: death occurred in less than 2 hours after dosing due to respiratory failure and prostration was the most common pre-mortem clinical sign
Mortality:
Death occurred
in less than 2 hours in 62 % of the animals;
in 3-6 hours in 25 % of the animals and
in 7-12 h in 13 % of the animals
Clinical signs:
the most common pre-mortem clinical sign was prostration, tonic clonic convulsion occurred in one third of the animals
Death was due to respiratory failure
Survivorshad anorexiam polydipsiy polyuriam fever convulsive movements and gastrointestinal disturbances during the first 24 hours but rapidly returned to normal thereafter
Body weight:
no data
Gross pathology:
At autopsy, the parietal cells mucous neck cells and surface epithelium of the pyloric stomac were shrunken and there was loss of weight of this organ.
There were also areas of capillary and venous congestion in the lamina propria and submucosa in the pyloric stomach and occasional hemorrhage and necrosis of the surface epithelium. The heart was dilated with blood and the respiratory alveoli were frequently collapsed; the spleen was contracted. The columnar epithelium covering the intestinal villi was shrunken and the goblet cells dilated. There were area of early necrosis in the renal tubular epithelium.

Applicant's summary and conclusion

Executive summary:

In an acute oral toxicity study female Wistar rats received 0, 2100, 2400, 2700, 3300, 3600, 3900 mg/kg bw potassium chloride dissolved in water. The LD50 value has been determined 3020 mg/kg bw. Clinical signs of intoxication in animals that died included convulsions followed by exhaustion and respiratory failure Autopsy revealed signs of irritant gastro-enterisis and necrosis appeared in the renal tubular epithelium. Animals that survived had convulsive movements diarrheam or sonstipation loss of appetite increase thirst and urine excretion and fever, Measurements of clinical sigh´ns were within the normal range within 2 -3 days and organ weights and water levels returned to normal limits in survivors at 2 weeks after administration of potassium chloride (Boyd 1969, UNEP 2003)