Registration Dossier
Registration Dossier
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EC number: 231-714-2 | CAS number: 7697-37-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: Experimental study of a supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 422 and GLP procedures. The read-across rationale can be found in the category approach document attached in Section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422
- Deviations:
- not specified
- GLP compliance:
- yes
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:
- no data
Purity not indicated
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- no data
- 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
- Duration of test:
- tox group: 28 days
repro group: 53 days
- No. of animals per sex per dose:
- 5 males/group
10 females/group
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: no effects observed up to the highest dose tested
Results (fetuses)
Effect levels (fetuses)
- 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 observed up to the highest dose tested
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
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
Toxicity 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. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. A slight increase in blood urea nitrogen was observed in male and female rats at 1,500 mg/kg/day and in female rats at 750 mg/kg/day. Although outside the range of the historical control, the absence of other indicators of renal dysfunction (e.g., creatinine) discounted the clinical significance of this endpoint. Minimal changes in electrolyte levels in male rats (e.g., 10% decrease in potassium, 4% decrease in calcium, and 22% increase in phosphorus) and female rats (3% decrease in chloride, 4% decrease in magnesium) were observed at 1,500 mg/kg/day. These changes were within the range of historical control and were not considered to be of biological significance. No treatment-related histopathological changes were reported.
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)
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