Registration Dossier
Registration Dossier
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EC number: 432-240-0 | CAS number: 12056-51-8
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- Developmental Toxicity Study
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- The study contains experimental data of a read-across analogue
Data source
Reference
- Reference Type:
- other: secondary literature
- Title:
- Reproductive and Developmental Toxicity Study
- Author:
- Diawoye
- Year:
- 2 001
- Bibliographic source:
- OECD SIDS
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Test chemical (Potassium chloride) was administered daily to wistar rats to evaluate the reprodcution and developmental toxicity.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- Not specified
Test material
- Reference substance name:
- Potassium chloride
- EC Number:
- 231-211-8
- EC Name:
- Potassium chloride
- Cas Number:
- 7447-40-7
- Molecular formula:
- ClK
- IUPAC Name:
- Potassium chloride
- Test material form:
- solid
- Details on test material:
- Name of the test chemical:Potassium chloride
Molecular Weight: 74.55 g/mol
Molecular Formula: KCl
Substance Type: Inorganic
Physical State: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Not specified
- Details on mating procedure:
- Not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Ten days (day 6 to 15 of gestation)
- Frequency of treatment:
- Daily
- Details on study schedule:
- Not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 3.1 mg/kg bw/day (nominal)
- Dose / conc.:
- 14.4 mg/kg bw/day (nominal)
- Dose / conc.:
- 66.8 mg/kg bw/day (nominal)
- Dose / conc.:
- 310 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 21 - 24 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.
- Positive control:
- No positive control included.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Not specified
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were recorded on days 0, 6, 11, 15 and 20 of gestation.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Litter observations: Survival, sex ratio, average offspring weight.
- Postmortem examinations (parental animals):
- Not specified
- Postmortem examinations (offspring):
- External congenital abnormalities, soft tissue defects (cleft palate), or skeletal defects (sternebrae, ribs, vertebrae, skull and extremities)
- Statistics:
- Not specified
- Reproductive indices:
- Ovaries and uterine content:
sex, number of corpora lutea, implantation sites , resorptions sites, live and dead fetuses. - Offspring viability indices:
- 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.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment related effects observed in clincal signs.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 310 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- reproductive performance
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- No effects seen in external congenital abnormalities, soft tissue defects (cleft palate), or skeletal defects (sternebrae, ribs, vertebrae, skull and extremities).
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 310 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- viability
- sexual maturation
- clinical signs
- mortality
- body weight and weight gain
- other: No effects seen in external congenital abnormalities, soft tissue defects (cleft palate), or skeletal defects (sternebrae, ribs, vertebrae, skull and extremities).
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on all observations, the study derived No Observed Adverse Effect Level (NOAEL) was 310 mg/kg bw/day.
- Executive summary:
A Reproduction and developmental toxicity study was performed with the test chemical in virgin adult wistar rats. 21 - 24 pregnant female rats received 3.1, 14.4, 66.8, 310.0 mg/kg bw /day from gestation day 6 to gestation day 15 by gavage. The controls were sham treated with the vehicle at a level equivalent to the group receiving the highest dose. Body weights were recorded on days 0, 6, 11, 15 and 20 of gestation. The dams were subjected to Caesarean section on gestation day 20. Post exposure observation period: 5 days. The urogenital tract of each dam was examined in detail for anatomical normality. The administration of up to 310 mg/kg body weight of test item to pregnant rats for 10 consecutive days had no clear discernible effects on nidation or on maternal or offspring survival. The number of abnormalities seen in either soft or skeletal tissues of the test group did not differ from the controls.
General parental toxicity: No effects seen in survival, total number of corpora lutea, implant sites, resorptions, soft tissue observations (urogenital tract), or live offspring.
Toxicity to offspring: No effects seen in survival, sex ratio, average offspring weight, external congenital abnormalities, soft tissue defects (cleft palate), or skeletal defects (sternebrae, ribs, vertebrae, skull and extremities).
Based on all observations, the study derived No Observed Adverse Effect Level (NOAEL) was 310 mg/kg bw/day.
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