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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from 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:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 422
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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

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)