Registration Dossier
Registration Dossier
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EC number: 231-211-8 | CAS number: 7447-40-7
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: only males were used; only English abstract and tables available
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Chronic toxicity test of KCl abd NaCl in F344/Slc rat
- Author:
- Imai, Sh, Morimoto J, Sekiya N, Shima M, Kiyozuka Y, Nakamori K, Tsubura Y
- Year:
- 1 961
- Bibliographic source:
- J Nara Med Ass 37, 115-127
- Reference Type:
- review article or handbook
- Title:
- Potassium chloride (CAS-Nr. 7447-40-7)
- Author:
- UNEP
- Year:
- 2 003
- Bibliographic source:
- United Nations Environmental Program
Materials and methods
- Principles of method if other than guideline:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- 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
- Molecular formula:
- KCl
- IUPAC Name:
- potassium chloride
- Details on test material:
- purity commercial grade
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: F344/Slc
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- Duration of test:
- 2 years
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.25, 1, 5 % in diet (corresponding to 0, 110, 450, 1820 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent no treatment
- Statistics:
- no data
Results and discussion
Effect levels
- Dose descriptor:
- other: no effects on reproductive organs
- Effect level:
- >= 110 - <= 1 820 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: No changes were reported in the absolute and relative organ weights of the testesm seminal vesicle and prostate
Applicant's summary and conclusion
- Executive summary:
Groups of male F344/Slc rats received 0, 0.25, 1, 5 % KCl in diet (corresponding to 0, 110, 450, 1820 mg/kg bw/day) over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period. No changes were reported in the absolute and relative organ weights of the testes, seminal vesicle and prostate or of histopathological changes of these organs (Imai 1961)
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