Registration Dossier
Registration Dossier
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EC number: 239-289-5 | CAS number: 15245-12-2
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 422 and GLP procedures
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Potassium nitrate
- EC Number:
- 231-818-8
- EC Name:
- Potassium nitrate
- Cas Number:
- 7757-79-1
- Molecular formula:
- HNO3.K
- IUPAC Name:
- potassium nitrate
- Details on test material:
- - Name of test material (as cited in study report): KNO3
purity: not indicated
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on mating procedure:
- - Length of cohabitation: 14 days
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Animals on the study were divided between two subgroups (toxicity and reproductive subgroups). The exposure period for males and females in the toxicity subgroup was 28 days. The exposure period for reproductive subgroup males was at most 28 days. The exposure period for reproductive subgroup females was at most 53 days (14 days pre-mating, 14 days mating, and gestational and lactational periods up to lactation day 4).
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 750, and 1,500 mg/kg/day
Basis:
- No. of animals per sex per dose:
- 5 males/group
10 females/group - Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Doses were selected based on parameters assessed in a range-finding study at concentrations up to 1,000 mg/kg/day.
- Positive control:
- not applicable
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
gestation length
gestation index
litter size - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in offspring:
number and sex of pups, survival indices, presence of gross anomalies, weight gain - Postmortem examinations (parental animals):
- HISTOPATHOLOGY
Histology for reproductive subgroup animals was restricted to retained reproductive organs (and any other abnormalities observed at necropsy).
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
Details on results (P0)
all animals mated within 4 days
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects at highest dose tested
Results: F1 generation
General toxicity (F1)
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Gross pathological findings:
- no effects observed
Effect levels (F1)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Reproductive subgroup: There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Mating performance and fertility were unaffected by treatment. All animals mated within 4 days. There were no treatment-related effects on gestation length, gestation index, litter size, offspring survival indices, sex ration, offspring bodyweight, or macropathology for offspring.
Applicant's summary and conclusion
- Conclusions:
- NOAEL: 1,500 mg/kg/day (general toxicity)
1,500 mg/kg/day (reproduction/developmental toxicity)
LOAEL: No adverse effects were seen on general toxicity endpoints. No adverse effects were seen on reproduction/developmental toxicity endpoints.
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