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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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro genetic toxicity studies using potassium niobate were not available, therefore data from two similar substances (Nb and K compounds) were used.
In a mammalian cell HPRT gene mutation assay, according to OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test), V79 cells cultured in vitro were exposed to niobium pentachloride (decomposed) (99.9 %) at concentrations of 0.025, 0.05, 0.10, 0.25, 0.50, 0.75, 1.0, 1.5 and 2.0 mM in the presence and absence of mammalian metabolic activation. There was no evidence of induced mutant colonies over background. The positive controls did induce the appropriate response. (Wallner, 2015)
The test compound NbCl5 was also considered to be negative in the Bacillus subtilis Rec Assay. (Kada, 1980)
In a reverse gene mutation assay in bacteria conducted similar to OECD test guideline 471, strains TA1535, TA1537, TA1538, TA98 and TA100 of Salmonella typhimurium were exposed to Potassium chloride at concentrations of 0, 1.86, 2.92, 5.84, 11.7 and 23.4 mg/plate in the presence and absence of mammalian metabolic activation. There was no evidence of induced mutant colonies over background in all tester strains. Therefore, Potassium chloride is considered to be non-mutagenic in this Salmonella typhimurium reverse gene mutation assay. (Seeberg et al. 1988)
In a reverse gene mutation assay in bacteria conducted similar to OECD test guideline 471, strains TA98, TA100, TA1535 and TA1537 of Salmonella typhimurium were exposed to Potassium chloride at concentrations of 10, 33, 100, 333, 1000, 3333 and 10000 µg/plate in the presence and absence of mammalian metabolic activation. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background in all tester strains. Therefore, Potassium chloride is considered to be non-mutagenic in this Salmonella typhimurium reverse gene mutation assay.(Mortelmans, 1986)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: guideline study from supporting substance (structural analogue)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- see box "Principles of method if other than guideline"
- Principles of method if other than guideline:
- Study conducted similar to OECD 471. However, only four Salmonella typhimurium strains were used.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Name of the test material (as cited in study report): Potassium chloride
- CAS number: 7447-40-7
- Purity: 99.99
- Source: Aldrich - Target gene:
- Histidine locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Cells were obtained from Dr. Bruce Ames, University of California, Berkeley, USA. - Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat and hamster metabolic activation systems
- Test concentrations with justification for top dose:
- Test concentrations: 10, 33, 100, 333, 1000, 3333, 10000 µg/L
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: H2O
- Untreated negative controls:
- yes
- Remarks:
- Potassium chloride
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537, without S9
- Untreated negative controls:
- yes
- Remarks:
- Potassium chloride
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all four strains, with S9
- Untreated negative controls:
- yes
- Remarks:
- Potassium chloride
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 and TA100, without S9
- Untreated negative controls:
- yes
- Remarks:
- Potassium chloride
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- TA98, without S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
EXPERIMENTAL PERFORMANCE
All chemicals were assayed for mutagenicity in the preincubation assay [Haworth et al., 1983]. To each of 13 x 100-mm test tubes maintained at 37 °C were added in the following order: 0.5 mL of S-9 mix or 0.1 M PO4 buffer (pH 7.4), 0.05 mL of the overnight culture, and 0.05 mL of solvent or chemical dilution. The mixture was mixed and allowed to incubate without shaking at 37 °C for 20 min, at which time 2.5 mL (EGG) or 2.0 mL (CWR, SFU) of molten (45 °C) top agar supplemented with 0.5 mM L-histidine and 0.5 mM D-biotin were added. The contents of the tubes were mixed and poured onto 25 mL of minimal glucose bottom agar [Vogel and Bonner, 1956] in 15 x 100-mm plastic petri dishes and Fisher Scientific plates. When the top agar had solidified, the
plates were inverted and incubated at 37 °C for 48 hr.
DURATION
- Preincubation period (Experiment II): 20 min at 37 °C
- Exposure duration: 48 h in the dark at 37 °C
NUMBER OF REPLICATIONS: 3 plates/strain/dose level per experiment. All experiments were repeated.
DETERMINATION OF CYTOTOXICITY
Cytotoxicity can be detected by appearance of his negative pinpoint colonies, reduced numbers of revertant colonies per plate, or thinning or absence of the bacterial lawn. - Evaluation criteria:
- The criteria used for data evaluation were the same as those described previously [Haworth et al., 1983] and are summarized as follows: 1) mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold; 2) nonmutagenic response: when no increase in the number of revertants was elicited by the chemical; 3) questionable response: when there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants were not reproducible; or when the response was of insufficient magnitude to support a determination of mutagenicity. The initial determination of mutagenic, nonmutagenic, or equivocal was made by the testing laboratory; the final determination was made by the project officer (E.Z.). The chemicals were decoded by the chemical repository (Radian Corporation) only after the mutagenicity or nonmutagenicity of the chemicals had been determined.
- Key result
- Species / strain:
- other: TA1535, TA1537, TA100 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- For detailed results please refer to table 1 in box "Any other information on results incl. tables"
- Remarks on result:
- other: non-mutagenic
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item can be considered as non-mutagenic.
- Executive summary:
In a reverse gene mutation assay in bacteria conducted similar to OECD test guideline 471, strains TA98, TA100, TA1535 and TA1537 of Salmonella typhimurium were exposed to Potassium chloride in water at concentrations of 10, 33, 100, 333, 1000, 3333 and 10000 µg/plate in the presence and absence of mammalian metabolic activation. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background in all tester strains. Therefore, Potassium chloride is considered to be non-mutagenic in this Salmonella typhimurium reverse gene mutation assay.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Study conducted simliar to OECD 471.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- TEST MATERIAL
- Name: Potassium Chloride
- CAS number: 7447-40-7
- Batch: 29594
- Purity: 99.5%
- Source: B.D.H. Italia, Milano - Species / strain / cell type:
- other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Cells were obtained from Dr. Bruce Ames, University of California, Berkeley, USA - Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Test concentrations: 0, 1.86, 2.92, 5.84, 11.7 and 23.4 mg/plate
- Vehicle / solvent:
- Test solutions were prepared dissolving the test material directly in tissue culture media.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
EXPERIMENTAL PERFORAMNCE
Cultures were grown overnight in a shaking water-bath in nutrient broth no. 2 from frozen stocks, and were used freshly. All incubations were at 37°C . Ames pour-plate assays were performed according to the methods described by Ames et al (1975). three plates were prepared at each test point, and all the results presented are the mean of the least two experiments performed.
NUMBER OF REPLICATIONS: 3 plates/strain/dose level per experiment. All experiments were repeated. - Key result
- Species / strain:
- other: TA 353, TA 1537, TA 1538, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- For detailed results please refer to table 1 in box "Any other information on results incl. tables"
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item can be considered as non-mutagenic.
- Executive summary:
In a reverse gene mutation assay in bacteria conducted similar to OECD test guideline 471, strains TA1535, TA1537, TA1538, TA98 and TA100
of Salmonella typhimurium were exposed to Potassium chloride in nutrient broth no. 2 at concentrations of 0, 1.86, 2.92, 5.84, 11.7 and 23.4 mg/plate in the presence and absence of mammalian metabolic activation.
There was no evidence of induced mutant colonies over background in all tester strains. Therefore, Potassium chloride is considered to be non-mutagenic in this Salmonella typhimurium reverse gene mutation assay.
- Endpoint:
- in vitro DNA damage and/or repair study
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientific publication, which meets national/scientific standards.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Different types of DNA damage are subjected to cellular recombination repair, thus recombinationless bacteria are usually more sensitive than the wild type bacteria. After incubation with the test compound the length of the inhibition zones are measured and compared between the wild type and mutant strain for assessing the mutagenic potential of the test compound NbCl5.
- GLP compliance:
- not specified
- Type of assay:
- Bacillus subtilis recombination assay
- Target gene:
- Rec system (rec45 arg try)
- Species / strain / cell type:
- bacteria, other: Bacillus subtilis
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
B-2 broth: (meat wet extract, 10 g; polypeptone dry powder, 10 g; NaCl, 5 g; water, 1000 ml; pH adjusted to 7.0.
Broth agar: 15g/L of agar added to the B-2 broth growing medium - Test concentrations with justification for top dose:
- A test concentration is not mentioned, but it is mentioned for assaying samples of unknown potency:
For assaying samples of unknown potency, it is recommended that the assay be initiated with doses as high as possible using saturated solutions of each drug in a solvent. A negative result can be concluded under these conditions. By repeating the assays using solutions of lower drug concentrations, the clearest positiveness can be detected at a drug concentration where the inhibition zone for Rec+ bacteria is very close to zero. - Vehicle / solvent:
- Besides water, available solvents are dimethylsulfoxide (DMSO), acetone, and ethyl acetate, which scarcely inhibit either Rec+ or Rec- bacteria, though no-drug "control" experiments must be carried out.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- Strains H17 Rec+ and M45 Rec- are grown overnight in B-2 broth. One milliliter 50% glycerol (wt./vol.) is added to 3 ml fully grown bacterial broth culture, and the mixture is stored at -80°C. On the day of the experiments, each culture is thawed and streaked on the "dry" surface of broth agar, and the paper disk containing the test drug is positioned. The plates are kept at 4-5°C for 24 hr, then incubated at 37°C for about 20 hr. The length of the inhibition zone is then measured.
- Species / strain:
- bacteria, other: Bacillus subtilis
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Under the described test conditions, the test compound NbCl5 is considered to be negative in the Bacillus subtilis Rec Assay.
- Executive summary:
In a Bacillus subtilis Rec Assay, the strain H17 Rec+ (rec+ arg try) and M45Rec- (rec45 arg try) were exposed to NbCl5. Only minor information were presented about the test compound concentration, the solubility and the used solvent/vehicle. Moreover, it is not clear, if positive controls were used during the test. Due to the simplicity of the assay and the well described protocol of Rec Assay
it can nevertheless be stated, that under the described test conditions, the test compound NbCl5 is considered to be negative in the Bacillus subtilis Rec Assay.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-01-07 to 2015-04-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Rationale for reliability: guideline study from supporting substance (structural analogue)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- HPRT
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Type and identity of media:
Short-term exposure: MEM medium, 100 U/100 µg/ml penicillin/streptomycin, 2 mM L-glutamine, 25 mM HEPES, 2.5 µg/ml amphotericin B
Long-term exposure: MEM Medium with 10 % fetal bovine serum (FBS), 100 U/100 µg/ml penicillin/streptomycin, 2 mM L-glutamine, 25 mM HEPES, 2.5 µg/ml amphotericin B - Metabolic activation:
- with and without
- Metabolic activation system:
- microsomal liver enzymes (S9)
- Test concentrations with justification for top dose:
- Pre-test for toxicity: 0, 0.0025, 0.005, 0.01, 0.05, 0.10, 0.25, 0.50, 1.0 mM without/with S9 mix
Main test:
Experiment I: 0, 0.025, 0.05, 0.10, 0.25, 0.50, 0.75, 1.0, 1.5 and 2.0 mM without/with S9 mix
Experiment II: 0, 0.005, 0.010, 0.025, 0.050, 0.10, 0.25, 0.50, 0.75, 1.0 mM without S9 mix
Experiment II: 0, 0.004, 0.007, 0.02, 0.04, 0.07, 0.2, 0.4, 0.7, 1.0 mM with S9 mix - Vehicle / solvent:
- - vehicle/solvent used: 1% Ethanol/9% Aqua ad injectabilia
- justification for choice of solvent: Solubility test and pre-test for toxicity - Untreated negative controls:
- yes
- Remarks:
- Treatment medium (MEM Medium)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1% ethanol/9% Aqua ad injectabilia
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation, final concentration 300 µg/ml
- Untreated negative controls:
- yes
- Remarks:
- Treatment medium (MEM Medium) plus S9 mix
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1 % ethanol/9% Aqua ad injectabilia plus S9 mix
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation, final concentration 0.8 and 1.0 µg/ml
- Details on test system and experimental conditions:
- Method of application: in medium
DURATION
- Preincubation period: 24 hours
- Exposure duration: 4 hours (short time exposure, Experiment I with and without metabolic activation)
20 hours (long time exposure, Experiment II with and without metabolic activation)
- Expression time (cells in growth medium): 6 days (subcultered after 3 days)
- Selection time (if incubation with a selection agent): 7-11 days
- Fixation time (start of exposure up to fixation or harvest of cells): 13-17 days
SELECTION AGENT (mutation assays): 6-Thioguanine
NUMBER OF REPLICATIONS: one culture per test group (expression period), 5 dishes per culture per test group (selection period)
DETERMINATION OF CYTOTOXICITY
- Methods: Relative Growth, Cloning efficiency - Evaluation criteria:
- - Negative and/or solvent controls fall within the performing laboratories historical control data range: 2-44 mutants/10^6 cells
-The absolute cloning efficiency: ([number of positive cultures x 100] I total number of seeded cultures) of the negative and /or
solvent controls is > 50%
-The positive controls (EMS and DMBA) induce significant increases (at least 3-fold increase of mutant frequencies related to the comparable negative control values and higher than the historical range of negative controls) in the mutant frequencies.
- A test is considered to be negative if there is no biological relevant increase in the number of mutants.
- There are several criteria for determining a positive result: a reproducible three times higher mutation frequency than the solvent control for at least one of the concentrations
- a concentration related increase of the mutation frequency; such an evaluation may be considered also in the case that a three-fold increase of the mutant frequency is not observed
- if there is by chance a low spontaneous mutation rate in the corresponding negative and solvent controls a concentration related increase of the mutations within their range has to be discussed.
- According to the OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary. - Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A biologically relevant growth inhibition (reduction of relative growth below 70%) was observed after the treatment with the test item in experiment I and II without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: The pH-value detected with the test item was within the physiological range (pH 7.0 ± 0.4).
- Effects of osmolality: not examined
- Precipitation: Precipitation of the test item was noted in experiment I without metabolic activation at concentrations of 0.5 mM and higher and with metabolic activation at concentrations of 0.25 mM and higher. In experiment II precipitation was detected at concentrations of 0.2 mM and higher with metabolic activation.
RANGE-FINDING/SCREENING STUDIES:
A solubility test was performed with different solvents and vehicles. Based on the results of the solubility test EtOH was used as solvent. After pre-dissolving the test item in EtOH (100 mM) a dilution series was prepared in EtOH. First a 9fold volume of phosphate buffer was used adding it to each concentration. After noticing that in the pre-experiment without metabolic activation the buffer reacts with the cells the phosphate buffer was replaced for the main experiments by Aqua ad injectabilia. So the 9fold volume of Aqua ad injectabilia was added to each concentration. After an initial reaction of approx. 10 minutes, this test item solution was added to cell culture medium (MEM without serum) at a ratio of 1 :10, resulting in 1% EtOH and 9% Aqua ad injectabilia in the final treatment medium. The pH-value detected with the test item was within the physiological range (pH 7.0 ± 0.4). The solvent used is a composition of well-established solvents and is compatible with the survival of the cells and the activity of the S9 mix The toxicity of the test item was determined in pre-experiments. Eight concentrations [0.0025, 0.005, 0.01, 0.050, 0.10, 0.25, 0.50, 1.0 mM] were tested without and with metabolic activation. In the pre-experiment the test item concentrations were dissolved in 1% ethanol and 9% phosphate buffer. The experimental performance for the pre-experiment was the same as described below for the main experiments (excepting the solvent composition)
COMPARISON WITH HISTORICAL CONTROL DATA:
In all experiments the mutant values of the negative controls, the solvent controls and all mutant values of the test item concentrations found were within the historical control data of the test facility (without metabolic activation: 2-43 mutants per 10^6 cells, with metabolic activation: 5-44 mutants per 10^6 cells - Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Under the experimental conditions, the test item niobium pentachloride (decomposed) is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
- Executive summary:
In a mammalian cell HPRT gene mutation assay, V79 cells cultured in vitro were exposed to niobium pentachloride (decomposed) (99.9 %) in 1% ethanol and 9% Aqua ad injectibilia at concentrations of 0.025, 0.05, 0.10, 0.25, 0.50, 0.75, 1.0, 1.5 and 2.0 mM in the presence and absence of mammalian metabolic activation (experiment I) and for experiment II at concentrations of 0.005, 0.010, 0.025, 0.050, 0.10, 0.25, 0.50, 0.75 and 1.0 mM without metabolic activation and 0.004, 0.007, 0.02, 0.04, 0.07, 0.2, 0.4, 0.7 and 1.0 mM with metabolic activation.
In experiment I and II with and without metabolic activation mutant values of the negative controls, the solvent controls and all mutant values of the test item concentrations found were within the historical control data.
For all tested treatment groups no dose-response relationship could be observed. The positive controls did induce the appropriate response. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5300, OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data.
Referenceopen allclose all
Table 1: Test results (Lab: CWR, Solvent: H2O)
|
TA100 |
TA1535 |
TA1537 |
TA98 |
||||||||||||||||||||
Dose |
Without hamster |
With 10% hamster S9 |
With 10% rat S9 |
Without hamster |
With 10% hamster S9 |
With 10% rat S9 |
Without hamster |
With 10% hamster S9 |
With 10% rat S9 |
Without hamster |
With 10% hamster S9 |
With 10% rat S9 |
||||||||||||
µg/plate |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
0 |
160 |
3.5 |
164 |
12.1 |
121 |
7.2 |
18 |
1.2 |
17 |
3.0 |
20 |
1.5 |
9 |
0.9 |
12 |
2.7 |
13 |
1.0 |
19 |
4.6 |
26 |
2.7 |
19 |
3.0 |
100 |
164 |
9.6 |
201 |
9.3 |
128 |
4.4 |
19 |
2.1 |
20 |
2.3 |
24 |
3.2 |
8 |
1.5 |
12 |
3.8 |
18 |
2.7 |
17 |
0.9 |
34 |
1.2 |
17 |
1.8 |
333 |
147 |
6.1 |
199 |
14.1 |
134 |
7.0 |
19 |
0.6 |
17 |
2.0 |
21 |
0.3 |
11 |
2.3 |
15 |
2.3 |
16 |
2.9 |
17 |
3.2 |
18 |
0.7 |
15 |
1.9 |
1000 |
166 |
2.2 |
199 |
11.4 |
115 |
4.0 |
15 |
1.5 |
22 |
1.3 |
15 |
2.9 |
11 |
1.2 |
12 |
1.5 |
14 |
1.3 |
15 |
3.2 |
18 |
2.2 |
20 |
1.2 |
3333 |
159 |
0.7 |
183 |
13.9 |
119 |
8.7 |
17 |
3.0 |
18 |
1.3 |
18 |
2.3 |
10 |
1.8 |
12 |
2.4 |
15 |
2.4 |
18 |
1.5 |
24 |
1.3 |
17 |
2.1 |
10000 |
t |
|
181 |
20.9 |
103 |
1.8 |
14 |
2.1 |
20 |
4.5 |
18 |
2.0 |
t |
|
11 |
1.5 |
15 |
1.3 |
14 |
3.0 |
19 |
0.3 |
18 |
2.8 |
POS |
1707 |
21.1 |
2583 |
115.7 |
2143 |
52.4 |
1224 |
75.1 |
298 |
12.2 |
260 |
9.5 |
888 |
239.7 |
184 |
42.5 |
500 |
11.3 |
259 |
10.0 |
1322 |
66.6 |
1321 |
38.8 |
Table 2: Test results (Lab: EGG, Solvent: H2O)
|
TA100 |
TA1535 |
TA1537 |
TA98 |
||||||||||||||||||||
Dose |
Without hamster |
With 10% hamster S9 |
With 10% rat S9 |
Without hamster |
With 10% hamster S9 |
With 10% rat S9 |
Without hamster |
With 10% hamster S9 |
With 10% rat S9 |
Without hamster |
With 10% hamster S9 |
With 10% rat S9 |
||||||||||||
µg/plate |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
0 |
180 |
7.3 |
145 |
7.2 |
162 |
8.4 |
41 |
10.1 |
9 |
1.2 |
7 |
1.5 |
10 |
3.1 |
12 |
2.2 |
9 |
1.2 |
18 |
0.6 |
28 |
3.7 |
35 |
2.9 |
100 |
187 |
6.7 |
145 |
8.1 |
146 |
11.1 |
37 |
1.5 |
14 |
2.7 |
12 |
2.0 |
4 |
1.9 |
11 |
2.2 |
8 |
0.3 |
21 |
3.2 |
31 |
0.6 |
34 |
5.5 |
333 |
187 |
0.9 |
158 |
4.5 |
152 |
8.7 |
38 |
4.4 |
9 |
0.9 |
10 |
3.0 |
5 |
1.7 |
10 |
3.2 |
14 |
2.7 |
21 |
1.3 |
31 |
1.5 |
33 |
6.1 |
1000 |
187 |
11.5 |
160 |
3.2 |
180 |
2.8 |
36 |
2.3 |
12 |
0.9 |
12 |
1.2 |
6 |
0.3 |
10 |
3.3 |
11 |
0.6 |
23 |
2.3 |
34 |
4.0 |
36 |
0.9 |
3333 |
164 |
6.1 |
167 |
6.1 |
159 |
4.2 |
33 |
7.0 |
12 |
0.9 |
9 |
1.5 |
6 |
1.3 |
10 |
0.7 |
8 |
1.2 |
21 |
1.9 |
36 |
2.0 |
31 |
1.2 |
10000 |
180 |
11.3 |
141 |
5.8 |
164 |
2.3 |
29 |
5.2 |
9 |
2.6 |
9 |
2.9 |
9 |
1.3 |
9 |
0.9 |
9 |
1.5 |
14 |
1.2 |
38 |
3.3 |
33 |
4.1 |
POS |
1166 |
14.8 |
1306 |
89.2 |
1821 |
113.5 |
965 |
44.4 |
131 |
7.9 |
101 |
3.9 |
334 |
191.8 |
142 |
4.3 |
125 |
5.5 |
1350 |
76.5 |
793 |
112.7 |
935 |
34.2 |
Table 1: Reversion of Salmonella tester strains by KCl
|
mg/plate |
1535 |
1537 |
1538 |
98 |
100 |
Absence of S9 |
0 |
21 |
17 |
22 |
38 |
127 |
|
1.86 |
27 |
19 |
25 |
32 |
140 |
|
3.73 |
25 |
17 |
25 |
25 |
132 |
|
7.45 |
26 |
16 |
29 |
33 |
144 |
|
14.9 |
29 |
18 |
25 |
30 |
134 |
|
29.8 |
28 |
17 |
28 |
29 |
145 |
Presence of S9 |
0 |
17 |
22 |
35 |
51 |
137 |
|
1.86 |
18 |
20 |
39 |
42 |
150 |
|
3.73 |
15 |
19 |
38 |
42 |
140 |
|
7.45 |
19 |
22 |
37 |
53 |
158 |
|
14.9 |
19 |
20 |
38 |
44 |
154 |
|
29.8 |
17 |
22 |
45 |
49 |
141 |
Table 4 | ||||||||||
Experiment I - Mutagenicity, without metabolic activation | ||||||||||
Dose Group | Concentration [mM] | Number of mutant colonies per flaska | Mean | SD | Mutant SD colonies per 106 cellsb |
Mutation factor | ||||
I | II | III | IV | V | ||||||
NC1 | 0 | 6 | 6 | 9 | 10 | 6 | 7.4 | 1.74 | 20.11 | |
NC2 | 4 | 6 | 6 | * | 8 | 6 | 1.41 | 18.29 | ||
S1 | 0 | 9 | 10 | 13 | 16 | 10 | 11 | 2.58 | 33.72 | |
S2 | 7 | 6 | 9 | 8 | 10 | 11.6 | 1.41 | 23.46 | ||
2 | 0.025 | 6 | 6 | 5 | 14 | 9 | 8 | 3.29 | 20.05 | 0.69 |
3 | 0.05 | 5 | 3 | 6 | 2 | 8 | 4.8 | 2.14 | 14.08 | 0.48 |
4 | 0.1 | 4 | 4 | 6 | 5 | 12 | 6.2 | 2.99 | 18.34 | 0.63 |
5 | 0.25 | 9 | 10 | 10 | 7 | 5 | 8.2 | 1.94 | 25.39 | 0.87 |
6 | 0.5 | 6 | 11 | 5 | 5 | 7 | 6.8 | 2.23 | 18.28 | 0.63 |
7 | 0.75 | 15 | 14 | 11 | 15 | 18 | 14.6 | 2.24 | 40.67 | 1.4 |
8 | 1.0 | 9 | 6 | 6 | 12 | 12 | 9 | 2.68 | 25.86 | 0.89 |
9 | 1.5 | 3 | 5 | 5 | 4 | 7 | 4.8 | 1.33 | 14.72 | 0.51 |
10 | 2.0 | 9 | 13 | 6 | 9 | 6 | 8.6 | 2.58 | 25.83 | 0.89 |
EMS | 300 µg/mL | 84 | 72 | 80 | 89 | 90 | 83 | 6.57 | 233.15 | 8.01 |
NC: | negative control/ medium control | |||||||||
S: | solvent control | |||||||||
a: | number of mutant colonies in flask I to V | |||||||||
b: | mean mutant colonies x 106/ (400000 x Cloning Efficiency/100) | |||||||||
EMS: | Ethylmethanesulfonate [300 µg/mL] | |||||||||
*: | Contamination of cell culture in flask |
Table 6 | ||||||||||
Experiment I - Mutagenicity, with metabolic activation | ||||||||||
Dose Group | Concentration [mM] | Number of mutant colonies per flaska | Mean | SD | Mutant SD colonies per 106 cellsb |
Mutation factor | ||||
I | II | III | IV | V | ||||||
NC1 | 0 | 5 | 5 | 6 | 6 | 11 | 6.6 | 2.24 | 20.06 | |
NC2 | 2 | 5 | 7 | 11 | 11 | 7.2 | 3.49 | 20.11 | ||
S1 | 0 | 3 | 5 | 6 | 7 | 10 | 6.2 | 2.32 | 18.62 | |
S2 | 3 | 4 | 9 | 9 | 10 | 7.0 | 2.90 | 19.83 | ||
2 | 0.025 | 4 | 4 | 5 | 6 | 10 | 5.8 | 2.23 | 14.61 | 0.76 |
3 | 0.05 | 5 | 12 | 8 | 3 | 8 | 7.2 | 3.06 | 18.56 | 0.97 |
4 | 0.10 | 11 | 10 | 11 | 10 | 11 | 10.6 | 0.49 | 30.64 | 1.59 |
5 | 0.25 | 5 | 6 | 7 | 10 | 14 | 8.4 | 3.26 | 20.64 | 1.07 |
6 | 0.50 | 2 | 2 | 4 | 5 | 5 | 3.6 | 1.36 | 9.65 | 0.50 |
7 | 0.75 | 3 | 7 | 8 | 9 | 9 | 7.2 | 2.23 | 19.15 | 1.00 |
8 | 1.0 | 4 | 8 | 11 | 12 | 12 | 9.4 | 3.07 | 25.61 | 1.33 |
9 | 1.5 | 7 | 7 | 8 | 8 | 9 | 7.8 | 0.75 | 18.22 | 0.95 |
10 | 2.0 | 7 | 7 | 9 | 9 | 11 | 8.6 | 1.50 | 22.34 | 1.16 |
DMBA | 0.8µg/mL | 105 | 107 | 133 | 96 | 97 | 107.6 | 13.41 | 303.95 | 15.81 |
DMBA | 1.0µg/mL | 111 | 149 | 118 | 122 | 109 | 121.8 | 14.39 | 369.09 | 19.20 |
NC: | negative control/ medium control | |||||||||
S: | solvent control | |||||||||
a: | number of mutant colonies in flask I to V | |||||||||
b: | mean mutant colonies x 106/ (400000 x Cloning Efficiency/100) | |||||||||
DMBA: | 7, 12-Dimethylbenz(a)anthracene [0.8 and 1.0 µg/mL] |
Table 8 | ||||||||||
Experiment II - Mutagenicity, without metabolic activation | ||||||||||
Dose Group | Concentration [mM] | Number of mutant colonies per flaska | Mean | SD | Mutant SD colonies per 106 cellsb |
Mutation factor | ||||
I | II | III | IV | V | ||||||
NC1 | 0 | 8 | 9 | 10 | 6 | 5 | 7.6 | 1.85 | 21.05 | |
NC2 | 14 | 8 | 5 | 9 | 12 | 9.6 | 3.14 | 26.89 | ||
S1 | 0 | 15 | 7 | 8 | 9 | 12 | 10.2 | 2.93 | 29.74 | |
S2 | 9 | 12 | 9 | 8 | 5 | 8.6 | 2.24 | 24.02 | ||
2 | 0.025 | 16 | 4 | 8 | 5 | 6 | 7.8 | 4.31 | 25.91 | 0.96 |
3 | 0.010 | 10 | 12 | 12 | 11 | 7 | 10.4 | 1.85 | 33.02 | 1.23 |
4 | 0.025 | 12 | 5 | 10 | 10 | 5 | 8.4 | 2.87 | 25.23 | 0.94 |
5 | 0.050 | 15 | 15 | 8 | 13 | 13 | 12.8 | 2.56 | 36.57 | 1.36 |
6 | 0.10 | 8 | 18 | 12 | 18 | 14 | 14.0 | 3.79 | 39.11 | 1.45 |
7 | 0.25 | 10 | 10 | 7 | 10 | 10 | 9.4 | 1.2 | 26.26 | 0.98 |
8 | 0.50 | 16 | 10 | 13 | 8 | 20 | 13.4 | 4.27 | 37.22 | 1.38 |
9 | 0.75 | 14 | 7 | 18 | 16 | 15 | 14.0 | 3.74 | 35.90 | 1.34 |
10 | 1.0 | 9 | 12 | 8 | 11 | 8 | 9.6 | 1.62 | 27.12 | 1.01 |
EMS | 300µg/mL | 160 | 175 | 179 | 169 | 177 | 172.0 | 6.87 | 607.77 | 22.61 |
NC: | negative control/ medium control | |||||||||
S: | solvent control | |||||||||
a: | number of mutant colonies in flask I to V | |||||||||
b: | mean mutant colonies x 106/ (400000 x Cloning Efficiency/100) | |||||||||
EMS: | Ethylmethanesulfonate [300 µg/mL] |
Table 10 | ||||||||||
Experiment II - Mutagenicity, with metabolic activation | ||||||||||
Dose Group | Concentration [mM] | Number of mutant colonies per flaska | Mean | SD | Mutant SD colonies per 106 cellsb |
Mutation factor | ||||
I | II | III | IV | V | ||||||
NC1 | 0 | 13 | 10 | 8 | 11 | 3 | 9.0 | 3.41 | 24.93 | |
NC2 | 19 | 12 | 18 | 12 | 16 | 15.4 | 2.94 | 43.38 | ||
S1 | 0 | 3 | 8 | 6 | 5 | 3 | 5.0 | 1.90 | 13.7 | |
S2 | 9 | 7 | 12 | 13 | 5 | 9.2 | 2.99 | 25.41 | ||
2 | 0.004 | 13 | 13 | 8 | 13 | 6 | 10.6 | 3.01 | 26.84 | 1.37 |
3 | 0.01 | 4 | 10 | 8 | 7 | 8 | 7.4 | 1.96 | 20.11 | 1.03 |
4 | 0.02 | 5 | 12 | 7 | 11 | 7 | 8.4 | 2.65 | 22.22 | 1.14 |
5 | 0.04 | 9 | 8 | 11 | 12 | 6 | 9.2 | 2.14 | 23.41 | 1.20 |
6 | 0.07 | 15 | 6 | 10 | 12 | 7 | 10.0 | 3.29 | 25.71 | 1.31 |
7 | 0.2 | 7 | 8 | 4 | 11 | 14 | 8.8 | 3.43 | 26.19 | 1.34 |
8 | 0.4 | 9 | 13 | 14 | 17 | 13 | 13.2 | 2.56 | 35.97 | 1.84 |
9 | 0.7 | 9 | 13 | 12 | 9 | 6 | 9.8 | 2.48 | 29.17 | 1.49 |
10 | 1.0 | 13 | 10 | 14 | 12 | 13 | 12.4 | 1.36 | 35.63 | 1.82 |
DMBA | 0.8µg/mL | 77 | 89 | 71 | 88 | 90 | 83.0 | 7.62 | 244.12 | 12.48 |
DMBA | 1.0µg/mL | 109 | 120 | 126 | 106 | 114 | 115.0 | 7.27 | 357.14 | 18.26 |
NC: | negative control/ medium control | |||||||||
S: | solvent control | |||||||||
a: | number of mutant colonies in flask I to V | |||||||||
b: | mean mutant colonies x 106/ (400000 x Cloning Efficiency/100) | |||||||||
DMBA: | 7, 12-Dimethylbenz(a)anthracene [0.8 and 1.0 µg/mL] |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on negative in vitro genetic toxicity data from two structurally similar substances, niobium pentachloride and potassium chloride, utilizing OECD 476 and OECD 471, respectively, can be concluded that potassium niobate would also be non-mutagenic.
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