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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
Endpoint summary
Administrative data
Description of key information
Skin Irritation/Corrosion:
In a in vitro skin corrosion study conducted according to OECD guideline 439, the EpiDerm™-Skin Model was topically exposed to Potassium niobate (Purity > 99.8 %) for 3 mins and 60 mins. Corrosive potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was > 50% (88.3%) after 3 min treatment and > 15% (91.4%) after 60 min treatment. Based on this result, the test item is classified as a non-irritant according to the UN GHS.
In a primary dermal irritation study conducted according to OECD guideline 439, the EpiDerm™-Model (EPI-200 -SIT) was topically exposed to Potassium niobate (Purity > 99.8 %) for 60 mins and 42 h post incubation period. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The mean relative tissue viability (% negative control) was > 50% (89.7 %). Based on this result, the test item is classified as a non-irritant according to the UN GHS.
Eye Irritation:
The eye irritation potential of potassium niobate ( ≥ 99.8% purity) was investigated in the bovine cornea opacity and permeability assay in accordance to OECD 437 (BCOP). The test item was suspended with 0.9% NaCl to gain a 20% concentration. The corneal opacity was measured before and after treatment (4 hours). The mean in vitro irritation score was determined with 14.93. The positive control induced the appropriate responses, indicating the validity of the assay. Based on the results obtained, potassium niobate can not be classified and further testing in another suitable method was required.
In a subsequent primary eye irritation study, according to OECD 405, 0.1 g of the test item of purity ≥ 99.8% was instilled into the conjunctival sac of one eye of three male New Zealand White rabbits. The treated eye was rinsed with physiological saline 1 hour after the application. The untreated eye served as control. Control and treated animals were observed for a period of up to 9 days (until full reversibility of effects). 2 of 3 tested animals had an iritis score of ≥ 1 (mean value of 24, 48, 72h reading). In this study, the test item is an eye irritant under the UN GHS “Category 2.”
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-09-11 to 2017-10-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- Adopted 29th July, 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EpiDerm Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm^TM
- Tissue bach number(s): 20171402
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): MTT assay plate incubated at 37+/- 1 °C
EpiDerm Kit:
The EpiDerm^TM tissues were provided as kits (e.g. EPI-200; MatTek), consisting of the following components relevant for this study:
1x sealed plate containing e.g. 24 reconstructed epidermis units (area: 0.63 cm2); each reconstructed epidermis is attached to a cell culture insert and maintained on nutritive agar for transport (Lot: 25841)
2x 24-well plates
4x 6-well plates
1x bottle of assay medium (DMEM-based medium; Lot: 090717TMC)
1x bottle of DPBS Rinse Solution (Lot: 062717MGKA)
25 pieces Nylon Mesh circles (8 mm diameter, 200 µm pore)
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Using a wash bottle, the tissue will be gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT stock solution with 5 mg/mL MTT in PBS, diluted 1 + 4 with DMEM-based medium (final concentration: 1 mg/mL)
- Incubation time: 1h
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
The test is performed on a total of 4 tissues per dose group, 2 replicas for each treatment period (3 min and 60 min exposure time).
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERNCE
- killed tissue
- N. of replicates: two tissues per treatment period were treated with 25 mg of the test item (KT) and two killed tissues were left untreated
- Method of calculation used: The non-specific colour of additional killed tissues (NSCkilled) was calculated according to: NSCkilled [%] = [ODTKT/ODNK]*100
The true tissue viability is then calculated as the percent tissue viability obtained with living tissues minus NSMTT minus NSCliving plus NSCkilled.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
A test item is classified as non-corrosive if both of the following statements hold true: mean tissue viability after 3 min and 60 min treatment is not decreased to less than 50% and 15% of the corresponding negative control tissues, respectively.
A test item is classified corrosive (C, in accordance with UN GHS category 1) in any case, if the mean tissue viability after 3 min treatment is decreased below 50%: if viability is reduced to less than 50% after 3 min treatment and to more than 15% after 60 min treatment. A test item which decreases viability below 25% after 3 min treatment is classifed as corrosive in accordance with optional UN GHS sub-category 1A. - Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Name: Potassium niobate
- Batch No.: 20171402
- CAS No.: 12030-85-2
- Aggregate state at RT: solid powder
- Colour: white
- Storage conditions: RT, stored in tightly closed container
- Expiry Date: 22 August 2019
- Amount(s) applied (volume or weight with unit): 25 mg of the test substance mixed per 1 mL MTT medium was applied directly atop the EpiDerm^TM tissue.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL distilled water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL 8 N KOH - Duration of treatment / exposure:
- 3 min and 60 min
20 sec. betweeen dosin - Duration of post-treatment incubation (if applicable):
- 3 h MTT incubation period
- Number of replicates:
- 2 tissues per dose group and time point
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 mins exposure
- Run / experiment:
- Mean of replicates
- Value:
- 88.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minutes exposure
- Run / experiment:
- Mean of replicates
- Value:
- 91.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions, the test item showed no corrosive effects to the skin. The relative mean tissue viability after 3 min 60 min of exposure was > 50%. The test item is therefore considered "non-corrosive” in accordance with UN GHS.
- Executive summary:
In a skin corrosion study conducted according to OECD guideline 431, the EpiDerm™-Model was topically exposed to Potassium niobate (Purity > 99.8 %) for 3 mins and 60 mins. Corrosive potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The mean relative tissue viability (% negative control) was > 50% (88.3%) after 3 min treatment and > 15% (91.4%) after 60 min treatment. Based on this result, the test item is classified as a non-corrosive according to the UN GHS..
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-10-23 to 2017-11-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 28 Jul. 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EpiDerm Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.
- Vehicle:
- other: Dulbecco´s phosphate buffered saline (DPBS)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM
- Tissue batch number(s): 20171402
- Production date:
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): MTT assay plate incubated at 37+/- 1 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Tissue are washed by filling and emptying the inserts 15 times with DPBS and shaken to remove rests of the test item.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT stock solution with 5 mg/mL MTT in PBS, diluted 1 + 4 with DMEM-based medium (final concentration: 1 mg/mL)
- Incubation time: 3 h
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- N. of replicates : 3
- Method of calculation used: The non-specific colour of additional killed tissues (NSCkilled) was calculated according to:
NSCkilled [%] = [ODTKT/ODNK]*100
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin in accordance with regulation EC 1272/2008 (UN GHS "Category 2") if the viability after exposure and post-incubation is less or equal to 50%.
- The test substance is considered to be non-irritant to skin in accordance with regulation EC 1272/2008 (UN GHS "No Category") if the viability after exposure and post-incubation is more than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Name: Potassium niobate
- Batch No.: 20171402
- CAS No.: 12030-85-2
- Aggregate state at RT: solid powder
- Colour: white
- Storage conditions: RT, stored in tightly closed container
- Expiry Date: 22 August 2019
- Amount(s) applied (volume or weight with unit): 25 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL DPBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL 5% SDS solution - Duration of treatment / exposure:
- 35 min and 60 min
1 min between dosing - Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 89.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: if mean obsolute OD 570nm of the three negative control tissues is ≥ 0.8 and ≤ 2.8
- Acceptance criteria met for positive control: if mean relative tissue viability of the three positive cpntrol tissues is ≤ 20%
- Acceptance criteria met for variability between replicate measurements: standars deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is ≤ 18% - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions, Potassium niobate showed no irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
- Executive summary:
In a primary dermal irritation study conducted according to OECD guideline 439, the EpiDerm™-Model (EPI-200 -SIT) was topically exposed to Potassium niobate (Purity > 99.8 %) for 60 mins and 42 h post incubation period. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The mean relative tissue viability (% negative control) was > 50% (89.7 %). Based on this result, the test item is classified as a non-irritant according to the UN GHS.
Referenceopen allclose all
Table 2: Result of the Test Item Potassium niobate
Name | Negative control | Positive control | Test Item | ||||||
Tissue | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
Absolute OD570 | 1.625 1.644 | 1.601 1.592 | 1.495 1.528 | 0.114 0.113 |
0.084 0.084 | 0.088 0.088 | 1.496 1.526 | 1.423 1.430 | 1.333 1.325 |
OD570 (Blank Corrected) | 1.581 1.600 | 1. 557 1.548 | 1.451 1.484 | 0.070 0.069 | 0.040 0.040 | 0.044 0.044 | 1.452 1.482 | 1.379 1.3860 | 1.289 1.281 |
Mean OD570 of the Duplicates (Blank Corrected) | 1.591 | 1.552 | 1.467 | 0.07 | 0.04 | 0.044 | 1.467 | 1.383 | 1.285 |
Total Mean OD570 of 3 replicate tissues ( Blank corected) | 1.537* | 0.051 | 1.378 | ||||||
SD 0D570 | 0.063 | 0.016 | 0.091 | ||||||
Relative Tissue Viability (%) | 103.5 | 101 | 95.5 | 4.5 | 2.6 | 2.9 | 95.5 | 90 | 83.6 |
Mean Relative Tissue Viablity (%) | 100 | 3.3** | 89.7 | ||||||
SD Tissue Viability (%)*** | 4.1 | 1 | 5.9 | ||||||
CV (% viabilities) | 4.1 | 31.3 | 6.6 |
* Blank-corrected mean OD 570 nm of the negative control corresponds to 100% absolute tissue viability
** Mean relative tissue viabilitx of the three positive control tissues is ≤ 20%
*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-12-12 to 2018-03-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted, 9th October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: animal no. 1 approximately 35 weeks old, animal no. 2 approximately 36 weeks old and animal no. 3 approximately 37 weeks old
- Weight at study initiation: 3.8 – 4.3 kg
- Housing: - Housed in ABS-plastic or Noryl rabbit cages, floor 4200 cm2
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 + / - 3
- Humidity (%): 55 + / - 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material.
- Observation period (in vivo):
- up to 9 days
- Duration of post- treatment incubation (in vitro):
- N.A.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes with physiological saline 0.9% NaCl
- Time after start of exposure: 1 hour after the application
SCORING SYSTEM: Eye irritation scores according to Draze
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9d
- Other effects:
- No systemic changes or body weight changes were observed. However, local changes were observed.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In an in vivo acute eye irritation/corrosion study in rabbits, the test item was classified as an irritant under the GHS Criteria "Category 2."
- Executive summary:
In a primary eye irritation study, 0.1 g of the test item of purity ≥ 99.8% was instilled into the conjunctival sac of one eye of three male New Zealand White rabbits (obtained from Charles River Deutschland, 35, 36 and 37 weeks old respectively, 3.8 – 4.3 kg) for about one second. The treated eye was rinsed with physiological saline 1 hour after the application. The untreated eye served as control. Control and treated animals were observed for a period of 9 days. Irritation was scored by the method of Draize. All effects were reversible within 9 days after application.
Conjunctival redness, chemosis and iritis were observed with the highest score of 2, 1.33, and 1, respectively. 2 of 3 tested animals had an iritis score of ≥ 1, meeting the UN GHS for “Category 2A” for eye irritating effects.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-08-24 to 2017-12-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted 26th July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- cattle
- Strain:
- not specified
- Remarks:
- BCOP
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: uses isolated corneas obtained as a by-product from animals freshly slaughtered at the abattoir A. Moksel AG, Buchloe, Germany - Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): test item was suspended with 0.9% NaCl to gain a 20% concentration.
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 20%
- Lot/batch no. (if required): 17264409
- Purity: 0.9% NaCl
- Expiry date: 2017-11-15
- Source: B. Braun Melsungen AG, Carl-Braun-Str. 1, 34121 Melsungen, Germany
OTHER MATERIALS
- Imidazole (Sigma, lot no. SLBL7984V, expiry date: 30/11/2017)
- RPMI 1640 without phenol red
- Fetal bovine serum (FBS)
- L-glutamine
- Minimum essential medium (MEM) with phenol red (used for the rinsing of test substances only)
- Hanks’ balanced salt solution (HBSS) with Ca++ and Mg++ containing penicillin/ streptomycin
- Sodium fluorescein - Duration of treatment / exposure:
- 4h ± 5 minutes at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- Opacity measurements were performed before and directly after exposure.
The optical density at 490 nm was measured upon 90 minutes of incubation with fluorescein after exposure to the test item by using a spectrophotometer. - Number of animals or in vitro replicates:
- Three corneas each for potassium niobate, negative control (physiological saline 0.9% NaCl) and positive control (20 % imidazole in physiological saline 0.9 NaCl%).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): at least three times with MEM (containing phenol red)
- Time after start of exposure: 4h ± 5 minutes
SCORING SYSTEM:
In vitro irritation score (IVIS) = mean opacity value + (15x mean permeability OD490 value)
The IVIS cut-off values for identifiying test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation of serious eye damage (UN GHS No Category):
IVIS: ≤ 3 - UN GHS: No Category
IVIS: > 3 - ≤ 55 - UN GHS: No prediction can be made
IVIS: > 55 - UN GHS: Category 1
TOOL USED TO ASSESS SCORE:
Opacity measurement was performed with an opacitometer - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of replicates
- Value:
- 14.93
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No prediction can be made regarding the classification of the test substance Potassium niobate according to the evaluation criteria. Further testing in another suitable method is required.
- Executive summary:
The eye irritation potential of potassium niobate ( ≥ 99.8% purity) was investigated in the bovine cornea opacity and permeability assay in accordance to OECD 437. The test item was suspended with 0.9% NaCl to gain a 20% concentration. The corneal opacity was measured before and after treatment (4 hours). The mean in vitro irritation score was determined with 14.93. The positive control induced the appropriate responses, indicating the validity of the assay. Based on the results obtained, potassium niobate can not be classified and further testing in another suitable method is required.
Referenceopen allclose all
Table 1: Opacity
Cornea No. |
Test item |
Initial opacity |
Final opacity |
Change of opacity value |
Corrected opacity value |
1 |
Negative Control |
0.73 |
1.36 |
0.63 |
|
2 |
0.39 |
0.49 |
0.10 |
|
|
3 |
0.52 |
1.19 |
0.66 |
|
|
MV |
0.55 |
1.01 |
0.46 |
|
|
4 |
Positive Control |
1.15 |
98.20 |
97.05 |
96.59 |
5 |
1.19 |
84.99 |
83.81 |
83.34 |
|
6 |
1.26 |
100.26 |
99.01 |
98.54 |
|
MV |
1.20 |
94.49 |
93.29 |
92.82 |
|
7 |
Test Item |
-0.18 |
11.74 |
11.92 |
11.45 |
8 |
-0.11 |
17.623 |
17.73 |
17.27 |
|
9 |
-0.35 |
16.19 |
16.53 |
16.07 |
|
MV |
-0.21 |
15.18 |
15.39 |
14.93 |
MV = Mean value
Table 2: Permeability
Cornea No. |
Test item |
OD490 |
Corrected OD490 Value |
1 |
Negative Control |
0.012 |
|
2 |
0.010 |
|
|
3 |
0.006 |
|
|
MV |
0.009 |
|
|
4 |
Positive Control |
2.110 |
2.101 |
5 |
1.745 |
1.736 |
|
6 |
1.443 |
1.434 |
|
MV |
1.766 |
1.757 |
|
7 |
Test Item |
0.010 |
0.001 |
8 |
0.008 |
-0.001 |
|
9 |
0.013 |
0.004 |
|
MV |
0.010 |
0.001 |
Table 3: In Vitro Irritation Score
Cornea No. |
Test item |
Corrected Opacity |
Corrected OD490 Value |
IVIS |
1 |
Negative Control |
0.63 |
0.012 |
|
2 |
0.10 |
0.010 |
|
|
3 |
0.66 |
0.006 |
|
|
MV |
0.46 |
0.009 |
0.60 |
|
4 |
Positive Control |
96.59 |
2.101 |
|
5 |
83.34 |
1.736 |
|
|
6 |
98.54 |
1.434 |
|
|
MV |
92.82 |
1.757 |
117.17 |
|
7 |
Test Item |
11.45 |
0.001 |
|
8 |
17.27 |
-0.001 |
|
|
9 |
16.07 |
0.004 |
|
|
MV |
14.93 |
0.001 |
14.94 |
Table 4: Historical mean In Vitro Irritation Score of the Positive Control
|
IVIS Positive Control – Imidazole 20% |
Mean Value (MV) |
124.00 |
Standard Deviation (SD) |
17.90 |
MV – 2x SD |
88.20 |
MV + 2x SD |
159.81 |
Number of Replicates providing Historical Mean: 29 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the result from a primary eye irritation study, according to OECD guideline 405, potassium niobate needs to classifed as an eye irritant, category 2, H319 according to CLP regulation 1272/2008.
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