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Toxicological information

Repeated dose toxicity: other routes

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Administrative data

Endpoint:
repeated dose toxicity: other route
Remarks:
Intraperitoneal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1965, July - August
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
The toxicity of Niobium salts
Author:
Downs W.L. et al.
Year:
1965
Bibliographic source:
American Industrial Hygiene Association Journal, 26:4, 337 - 346

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: To investigate the acute and sub-acute toxicity of Potassium Niobate
- Short description of test conditions: Fours groups of five male rats each were given daily intraperitoneal injections of an aqueous solution of potassium niobate (50 mg / ml) at doses of 10, 29, 57 and 95 mg Nb/kg. A fifth group was injected with a solution of KOH (0.27 M) at a dose of 5 ml / kg and served as control.
- Parameters analysed / observed: mortality, gross pathology, histopathology
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium niobate
EC Number:
234-744-4
EC Name:
Potassium niobate
Cas Number:
12030-85-2
Molecular formula:
K.NbO3
IUPAC Name:
niobium(5+) potassium trioxidandiide
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Union Carbide Metals Co., Niagara Falls, N.Y.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Average weight: 200-224 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
15 days
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Dose / conc.:
10 other: mg Nb / kg
Dose / conc.:
29 other: mg Nb / kg
Dose / conc.:
57 other: mg Nb / kg
Dose / conc.:
95 other: mg Nb / kg
No. of animals per sex per dose:
4 groups of 5 male rats per dose
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
BODY WEIGHT: Yes
- Time schedule for examinations: Not specified
Sacrifice and pathology:
GROSS PATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
mortality observed, treatment-related
Description (incidence):
- All rats survived the lowest dose of 10 mg / kg and only one control rat died.
- All rats given the highest dose died within the first four days and two rats given doses of 57 Nb / kg died
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
- Repeated injections of potassium niobate resulted in a decrease in body weight. At the lowest dose (19 mg Nb / kg) an average gain, in body weight, of only 9 g was observed whereas the control rats gained an average of 36 g during the 15 day period.
- The rats receiving repeated doses of 29 mg Nb / kg showed a slight decrease in weight while a marked weight loss was observed in the rats given doses of 57 mg NB / kg or greater.
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
- Gross examination revealed pale and enlarged kidneys in the rats given the highest dose. Mean weight was 3.5 g which is considerably higher than the mean value of 1.9 g for control rats.
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
The kidneys of four of the five rats receiving the lowest dose showed evidence of slight renal damage with scattered tubules containing precipitated pigment associated with epithelial proliferation. No frank necrosis was seen. Kidneys from the three rats which received 11 doses of 29 mg Nb/kg showed marked renal damage. This injury was characterized by the presence of a yellow granular pigment in many tubular lumina and in the cells lining the tubules. Renal tubular necrosis, purulent and hyaline casts, and extensive regenerative changes were frequently seen. Similar changes were noted in the kidneys of one rat given five doses of 57 mg Nb/kg and in two rats which received three doses of 95 mg Nb/kg. No abnormalities were observed in the kidneys of the control rats.

Effect levels

Key result
Dose descriptor:
LOAEL
Effect level:
10 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
body weight and weight gain
gross pathology

Applicant's summary and conclusion

Conclusions:
In an intraperitoneal toxicity study, the test item was administered at doses of 10, 29, 57 and 95 mg / kg bw on four groups of 5 male Wistar rats each, daily for 15 days. The effects included decrease in body weight, renal injury and increased mortality.
Executive summary:

In an intraperitoneal toxicity study, the test item was administered at doses of 10, 29, 57 and 95 mg / kg bw on four groups of 5 male Wistar rats each, daily for 15 days. The effects included decrease in body weight, renal injury and increased mortality.