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EC number: 234-744-4 | CAS number: 12030-85-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-08-24 to 2018-01-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- 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
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Batch No.: 20171402
- CAS No.: 12030-85-2
- Purity: ≥ 99.8%
- Physical State: solid powder
- Colour: white
- Storage Conditions: room temperature, store in a tightly closed container
- Expiry Date: 2019-08-22
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Number of animals per group: 6 female
- Age at start of treatment: 9 - 11 weeks
- Body weight at start of treatment: Step 1: animals no. 1 - 3: 175 - 201 g; Step 2: animals no. 4 - 6: 185 - 194 g
- Identification: tail painting
- Acclimatization: at least 5 days
- Housing: in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: ad libitum, pAltromin 1324 maintenance diet for rats and mice; removal of food 16 - 19 hrs before administration of test material until 4 hrs after administration
- Water: ad libitum, tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/-3 °C
- Humidity (%): 55 +/-10 % R.H.
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes per hour: 10
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
- Doses:
- once 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
OBSERVATION
- Weighing: day before dosing and Day 1, 8 and 15
- Mortality/Viability: there was no death
- Clinical signs: Day 1: at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose; daily thereafter
- Necropsy of survivors performed: yes, all animals were sacrificed - Statistics:
- LD50 values and associated 95 % confidence interval
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- femals 0/6
- Clinical signs:
- other: slight to moderate piloerection, slightly reduced spontaneous activity during first 2 days; the animals were overtly normal by the 3rd day
- Gross pathology:
- Necropsy, on Day 15, revealed no significant macroscopic lesion.
Any other information on results incl. tables
Table 1: Results per Step
Step |
Sex / No. |
Starting dose (mg/kg bw) |
Number of animals |
Number of intercurrent deaths |
Step 1 |
Female / 1 - 3 |
2000 |
3 |
0 |
Step 2 |
Female / 4 - 6 |
2000 |
3 |
0 |
bw = body weight
Table 2: Clinical Signs - Individual Data
Step |
Animals No./Sex |
Starting Dose (mg/kg bw) |
Timepoint |
Observations |
1 |
1, 2, 3 / female |
2000 |
0 – 30 min |
Nsf |
30 – 60 min |
Slight piloerection |
|||
60 – 120 min |
Slightly reduced spontaneous activity, moderate piloerection |
|||
120 – 180 min |
Slight piloerection |
|||
180 – 240 min |
Moderate piloerection |
|||
240 min – d 2 |
Slight piloerection |
|||
d 2 – d 15 |
nsf |
|||
2 |
4, 5, 6 / female |
2000 |
0 – 120 min |
nsf |
120 – 180 min |
Slight piloerection |
|||
180 min – d 15 |
nsf |
d = day, min = minute, nsf = no specific findings
Table 3: Absolute body weights in g and body weight gain in %
Step |
Animal No. / Sex |
Starting dose (mg/kg bw) |
bw (g) |
Body weight gain in comparison to day 1 (%) |
||
Day 1 |
Day 8 |
Day 15 |
||||
1 |
1 / female |
2000 |
192 |
200 |
212 |
10 |
2 / female |
175 |
199 |
205 |
17 |
||
3 / female |
201 |
227 |
227 |
13 |
||
2 |
4 / female |
2000 |
194 |
219 |
226 |
16 |
5 / female |
186 |
209 |
218 |
17 |
||
6 / female |
185 |
200 |
210 |
14 |
Table 4: Findings of the necropsy - individual data
Step |
Animal No. / Sex |
Starting dose (mg/kg bw) |
Organ |
Macroscopic findings |
1 |
1 / female |
2000 |
- |
nsf |
2 / female |
- |
nsf |
||
3 / female |
- |
nsf |
||
2 |
4 / female |
2000 |
- |
nsf |
5 / female |
- |
nsf |
||
6 / female |
- |
nsf |
Table 5: LD50 cut-off
Starting dose (mg/kg bw) |
Number of animals |
Number of intercurrent death |
LD50 Cut-off |
2000 |
6 |
0 |
unclassified |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats conducted according to OECD 423 no mortality occurred at the limit dose of 2000 mg/kg bw. Hence, the LD50 value was determined to be greater than 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (acute toxic class method, OECD 423), 6 fasted, 9 - 11 weeks old, female Wistar rats were given a single oral dose of Potassium niobate (≥ 99.8 % purity) in water at the limit dose of 2000 mg/kg bw and were observed for 15 days. All animals survived until the end of the study showing only mild signs of toxicity. The clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity and piloerection. All symptoms were no longer detectable by day 2 after dosing.
Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any animal of any step. Based on the results from this study, the oral LD50 in rats is considered to exceed 2000 mg/kg bw.
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