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EC number: 235-227-6 | CAS number: 12136-45-7
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- other: Published data
- Adequacy of study:
- supporting 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:
- publication
- Title:
- Toxicity and carcinogenicity of acidogenic or alkalogenic diets in rats; effects of feeding NH4Cl, KHCO3 or KCl
- Author:
- Lina BAR, Juijpers MHM
- Year:
- 2 004
- Bibliographic source:
- Food Chem Toxicol 42,135-153
- Reference Type:
- publication
- Title:
- The role of akalizing and neutral potassium salts in urinary bladder carcinogenesis in rats
- Author:
- Lina BAR, Hollanders VMH, Kuijpers MHM
- Year:
- 1 994
- Bibliographic source:
- Carcinogenesis 15, 523-527
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD TG 453
- Deviations:
- yes
- Remarks:
- prolongation of treatment time up to 30 months and only one dose used
- GLP compliance:
- not specified
- Type of method:
- in vivo
Test material
- Reference substance name:
- Potassium chloride
- EC Number:
- 231-211-8
- EC Name:
- Potassium chloride
- Cas Number:
- 7447-40-7
- IUPAC Name:
- potassium chloride
- Details on test material:
- purity :>99.5 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 weeks
- Housing: groups of 5 of same sex and same treatment group
- Diet ad libitum
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 35-70
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- male and female rats were fed diets containing 0 or 3 % KCL over a total period of 30 months
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- no details given
- Duration of treatment / exposure:
- 10 rats/sex/group: 13 weeks
15 rats/sex/group; 18 months
50 rats/sex/group: 30 months - Frequency of treatment:
- coninuously in diet
- Duration of test:
- 30 months
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3 % in diet
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10 rats/sex/group: 13 weeks
15 rats/sex/group; 18 months
50 rats/sex/group: 30 months - Control animals:
- yes, concurrent no treatment
- Details on study design:
- male and female rats were fed diets containing 0 or 3 % KCL over a total period of 30 months: after 13 weeks 10 rats/sex/group were examined , after 18 months 15 rats/sex/group were examined and after 30 months 50 rats/sex / group were examined
- Statistics:
- ANOVA /LSD test, Mann-Whitney U-test. two-sided Fisher exactprobability test
Results and discussion
Effect levels
- Dose descriptor:
- conc. level:
- Effect level:
- ca. 3 other: % in diet
- Based on:
- other: nominal
- Sex:
- male/female
- Basis for effect level:
- other: no effects on reproductive organs were reported
Observed effects
No effects on reproductive organs were reported
Any other information on results incl. tables
BODY WEIGHT AND WEIGHT GAIN (graphic only)
30 months: mean body weights were decreased in males and females compared to controls
18 months: mean body weights in males were decreased when compared to controls
13 weeks no growth depression was observed
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
due to the reduction of feed intake the mean test substance intake decreased in time:
--13 w treatment males 29.9 mmol/kg bw , females: 35.2 mmol/kg bw
--18 month treatment, males: 20.8 mmol/kg bw , females 24.7 mmol/kg bw
--30 months treatment, males:19.5 mmol/kg bw , females:.22,6 mmol/kg bw
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
water intake was increased throughout the studies by ca 25 % in males and females
HAEMATOLOGY
blood gas analysis: base exess was not affected by feeding KCl
there were no consistent or treatment related effects on red blood cell variables , clotting potential or total and differential blood cell count
CLINICAL CHEMISTRY
Potassium levels in plasma were generally increased although the difference to the concurrent control was not significant (data not shown)
URINALYSIS
Urinary pH was not influenced by the feeding of KCl
the volume of the urine collected during 24 hours was generally increased in rats fed KCL
urinary potassium excretion was significantly increased in all groups that were fed KCl
GROSS PATHOLOGY/ ORGAN WEIGHTS
-With KCl the relative kidney weights tended to be increased but were not consistent
-there was no consistent or treatment related changes in the weights of the liver, spleen, ovaries , pituitary, thyroid, thymus or heart
-The analysis of femur ath the end of the studies did not reveal any effects of femur weight, calcium content or on total bone substance
-macroscopic examinations at necropsy did not reveal significant differences among the treatment group and the control group,
HISTOPATHOLOGY: NON-NEOPLASTIC
30 month-treatment:
in the adrenals, zona glomerulosa: hypertrophy in 24/50 treated rats versus 4/50 in controls,
in the urinary bladder: cystitis (males: 3/59; females 3/50) and single epithelial hyperplasia (males 3/50; females 2/50)
Applicant's summary and conclusion
- Conclusions:
- Male and female Wistar rats were fed diets containing 0 or 3 % KCL over a total period of 30 months: Examination after 13 weeks (10 rats/sex/group), after 18 months (15 rats/sex/group) and after 30 months (50 rats/sex /group). Due to the reduction of feed intake the mean test substance intake and mean body weight decreased in time. After 30 months treatment, reproductive organs on males and females were not affected by treatment.
- Executive summary:
Male and female Wistar rats were fed diets containing 0 or 3 % KCL over a total period of 30 months: Examination after 13 weeks (10 rats/sex/group), after 18 months (15 rats/sex/group) and after 30 months (50 rats/sex /group). Due to the reduction of feed intake the mean test substance intake and mean body weight decreased in time. After 30 months treatment, reproductive organs on males and females were not affected by treatment.
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