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EC number: 273-749-6 | CAS number: 69012-50-6 Product of blowing smelted nickel ore in a converter to lower the iron content.
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-06-05 through 2009-10-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not Applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Matte, nickel
- EC Number:
- 273-749-6
- EC Name:
- Matte, nickel
- Cas Number:
- 69012-50-6
- Molecular formula:
- Not applicable
- IUPAC Name:
- Nickel matte
- Details on test material:
- - Name of test material (as cited in study report): Nickel matte (N123-PTL)
- Physical state: granules/gray, black
- Composition of test material, percentage of components: Nickel Subsulfides <60%, Nickel Iron Sulfides <40%, Copper >10%, Cobalt <1%, Arsenic <0.1%, and Magnesium Oxide 4%.
- Stability: stable
- Lot/batch No.: not applicable
- Storage: at room temperature
Constituent 1
Method
- Target gene:
- Thymidine Kinase (TK)
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 complete medium (see specific descriptions below for culture, treatment and selective medium preparations)
Complete Culture Medium = RPMI 1640 medium supplemented with 15% horse serum, 100U/100 ug/ml Penicillin/Streptomycin, 1mM sodium pyruvate, 2mM L-glutamine, 25 mM HEPES, 250 ug/ml amphotericin B
Treatment Medium = RPMI 1640 medium supplemented with 3% horse serum, 100U/100 ug/ml Penicillin/Streptomycin, 1mM sodium pyruvate, 2mM L-glutamine, 25 mM HEPES, 250 ug/ml amphotericin B
Selective Medium = RPMI 1640 medium supplemented with TFT (5ug/mL)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes; stock cultures of the cleansed L5178Y cell line were utilized. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsome preparation (S9) from phenobarbital- and beta-naphtoflavone-induced rats
- Test concentrations with justification for top dose:
- The selection of the concentrations was based on data from the pre-experiments. In experiment 1 1000ug/mL (with metabolic activation) and
800 ug/mL (without metabolic activation) were selected as the highest concentrations. In experiment II 1000 uglmL (with metabolic activation) and
80 uglmL (without metabolic activation) were selected as the highest concentrations. Experiment II without metabolic activation was performed as a
24 h long-term exposure assay.
The test item was investigated at the following concentrations:
Experiment I
with metabolic activation:
300, 400, 500, 600, 700, 800, 900 and 1000 uglmL
and without metabolic activation:
100, 300, 400, 540, 620, 650, 680 and 800 uglmL
Experiment II
with metabolic activation:
100, 200, 400, 500, 600, 800, 925 and 1000 uglmL
and without metabolic activation:
0.5, 1, 2, 5, 10, 20, 40 and 80 uglmL
According to OECD Guidelines at least 8 concentrations of the test item were set up in the experiments with and without metabolic activation. - Vehicle / solvent:
- Nickel matte was suspended in cell culture medium (RPMI + 3% HS)
Controls
- Untreated negative controls:
- other: solvent or vehicle alone used as negative control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- used as negative control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethanesulfonate (EMS) and methylmethanesulfonate (MMS) used as positive controls without metabolic activation; benzo[a]pyrene used as positive control with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: For short-term exposure, 1 x 10^7 cells/mL (25cm2) flasks) were suspended in 11mL RPMI medium with 3% horse serum and exposed to designated concentrations of the test compound in the presence or absence of metabolic activation. For long-term exposure, 1 x 10^7 cells/mL (175cm2) flasks) were suspended in 50mL RPMI medium with 7.5% horse serum and exposed to designated concentrations of the test compound in the presence or absence of metabolic activation
DURATION/NUMBER OF CELLS/REPLICATIONS EVALUATED:
- Exposure durations: 4 hr and 24 hr
- Expression time (cells in growth medium): cells were suspended in 30 mL complete culture medium and incubated for an expression and growth period of 72 hr (for short-term exposure) or 48 hr (for long term exposure) at 37°C and 5% CO2/95% humidified air. The cell density was determined each day and adjusted to 3 x 10^5 cells/ml if necessary.
- Selection time (if incubation with a selection agent): Cells from each experimental group were seeded in four 96-well plates at a density of approximately 2000 cells/well in 200uL selective medium with TFT. Plates were scored after an incubation period of 11 to 14 days at 37°C in 5% CO2/95% humidified air.
SELECTION AGENT (mutation assays): RPMI 1640 complete culture medium supplemented with TFT (5 uglmL)
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; following the 72 hr or 48 hr expression time, the relative cloning efficiency (RCE) was determined. Cells were seeded in two 96-well plates, 1.6 cells/well (statistical number), and incubated for 6 days at 37°C in a humidified atmosphere with 5% CO2. Relative suspension and total growth (RSG and RTG; RTG = [RSG x RCE]/100) of the treated cell cultures were calculated according to the method of Clive and Spector.
DETERMINATION OF MUTATION FREQUENCY
Mutation frequencies were calculated from the data obtained from cultures (4 plates/dose group) used for the cloning efficiency (cultures with non selective medium) and those used for selection (cultures with selective medium): mutation frequency = (-ln[NC/TC (selective medium)])/(-ln[NC/TC(non selective medium)]) x 800.
NC: number of negative cultures
TC: total number of cultures seeded
DETERMINATION OF POTENTIAL CLASTOGENIC EFFECTS
Colony sizing was performed for the highest concentrations of the test substance and for the negative and positive controls. A mutation frequency above 2 in combination with an increased occurrence of small colonies (defined by slow growth and/or morphological alteration of the cell clone) indicated by a low large/small colony ratio (ratio of clastogenic controls MMS and/or B[a]P with a coefficient of 1.5), is an indication for potential clastogenic effects and/or chromosomal aberrations. - Evaluation criteria:
- Several criteria were used in determining a positive result:
(1) clear and dose-related increase in the mutant frequncy
(2) biologically relevant response (at least 2-fold increase of mutant frequencies related to the comparable negative control values and higher than the historical range of negative controls) for at least one of the dose groups
(3) combined with a positive effect in the mutant frequncy, an increased occurrence of small colonies (slow growth colonies) indicated by a low large/small colonies ratio (ratio of the clastogenic controls MMS and/or B[a]P with a coefficient of 1.5 is an indication for potential clastogenic effects and/or chromosomal aberrations.
A test item is considered to be negative if there is not biologically relevant increase in the induction of mutant cells above concurrent control levels, at any dose level. - Statistics:
- According to 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
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- non-mutagenic, non-clastogenic
- Cytotoxicity / choice of top concentrations:
- other: Growth inhibition observed in all experiments. Precipitation of the test item was noted in all concentrations in experiment I with and without metabolic activation and in experiment II with metabolic activation. In experiment II without metabolic activat
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
For both short- and long-term exposure, mutant values of the negative controls were within historical control data of the test facility. Mutant values from the all groups with and without metabolic activation were also within the range of historical control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Growth inhibition was observed in experiment I and II with and without metabolic activation. In experiment I with metabolic activation the relative total growth (RTG) was 0.08% for the highest concentration (1000 ug/mL) evaluated. The highest concentration evaluated without metabolic activation was 800 ug/mL with a RTG of 32.06 %. In experiment II with metabolic activation the relative total growth (RTG) was 0.39% for the highest concentration (1000 ug/mL) evaluated. The highest concentration evaluated without metabolic activation was 80 ug/mL with a RTG of 18.44%.
CLASTOGENICITY:
In experiment I (short-term exposure) and II (long-term exposure), with or without metabolic activation, colony sizing showed no clastogenic effects induced by the test item under the experimental conditions (with and without metabolic activation). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
RESULTS WITH METABOLIC ACTIVATION - Experiment I (short-term exposure)
Mutagenicity Data with metabolic activation (see Table 4 in original study report)
Test Group | Concentration (ug/mL) | RCE (%) | Mean* Number of Cultures/96 wells | Mutants/10^6 cells (Mutation Frequency) | Mutation factor |
NC1 | 0 | 100.00 | 33.25 | 126.33 | not applicable |
NC2 | 0 | 100.00 | 33.75 | 117.28 | not applicable |
1 (P) | 300 | 93.63 | 29.00 | 135.59 | 1.11 |
2 (P) | 400 | 95.84 | 33.75 | 149.82 | 1.23 |
3 (P) | 500 | 91.41 | 34.00 | 178.30 | 1.46 |
4 (P) | 600 | 92.52 | 34.25 | 173.16 | 1.42 |
5 (P) | 700 | 94.74 | 33.50 | 155.15 | 1.27 |
6 (P) | 800 | 63.16 | 19.00 | 195.87 | 1.61 |
7 (P) | 900 | 15.51 | 3.25 | 174.79 | 1.44 |
8 (P) | 1000 | 0.55 | 0.00 | 0.00 | 0.00 |
S[aIP | 3.5 | 95.29 | 66.00 | 411.41 | 3.38 |
*Based on 4 plates
NC: Negative Control
(P): Precipitation
B[a]P: Benz(a)pyrene
Colony Sizing, with metabolic activation (see Table 5 in original study report)
Test Group | Concentration (ug/mL) | Quotient Large/Small |
NC1 | 0 | 7.31 |
NC2 | 0 | 5.43 |
5 (P) | 700 | 5.09 |
6 (P) | 800 | 3.75 |
7 (P) | 900 | 3.33 |
8 (P) | 1000 | n.c. |
B[aIP | 3.5 | 1.64 |
NC: Negative Control
(P): Precipitation
B[a]P: Benz(a)pyrene
RESULTS WITHOUT METABOLIC ACTIVATION - Experiment I (short-term exposure)
Mutagenicity Data without metabolic activation (see Table 7 in original study report)
Test Group | Concentration (ug/mL) | RCE (%) | Mean* Number of Cultures/96 wells | Mutants/10^6 cells (Mutation Frequency) | Mutation factor |
NC1 | 0 | 100.00 | 22.75 | 124.99 | not applicable |
NC2 | 0 | 100.00 | 23.50 |
94.89 | not applicable |
3 (P) | 100 | 98.19 | 27.00 | 139.77 | 1.27 |
5 (P) | 300 | 104.82 | 28.50 | 119.04 | 1.08 |
6 (P) | 400 | 99.40 | 23.25 | 113.10 | 1.03 |
8 (P) | 540 | 112.05 | 30.75 | 89.13 | 0.81 |
9 (P) | 620 | 93.37 | 31.00 | 189.46 | 1.72 |
10 (P) | 650 | 102.41 | 24.75 | 110.10 | 1.00 |
11 (P) | 680 | 97.59 | 18.00 | 89.49 | 0.81 |
13 (P) | 800 | 79.52 | 21.25 | 172.08 | 1.57 |
EMS | 500 | 80.12 | 81.75 | 1293.33 | 11.76 |
MMS | 10 | 91.57 | 64.00 | 560.30 | 5.10 |
*Based on 4 plates
NC: Negative Control
(P): Precipitation
EMS: Ethylmethanesulfonate
MMS: Methylmethanesulfonate
Colony Sizing, without metabolic activation (see Table 8 in original study report)
Test Group | Concentration (ug/mL) | Quotient Large/Small |
NC1 | 0 | 14.17 |
NC2 | 0 | 17.8 |
10 (P) | 650 | 13.14 |
11 (P) | 680 | 6.2 |
13 (P) | 800 | 3.05 |
MMS | 10 | 1.13 |
NC: Negative Control
(P): Precipitation
MMS: Methylmethanesulfonate
RESULTS WITH METABOLIC ACTIVATION - Experiment II (long-term exposure)
Mutagenicity Data with metabolic activation (see Table 10 in original study report)
Test Group | Concentration (ug/mL) | RCE (%) | Mean* Number of Cultures/96 wells | Mutants/10^6 cells (Mutation Frequency) | Mutation factor |
NC1 | 0 | 96.70 | 28.50 | 154.52 | not applicable |
NC2 | 0 | 103.30 | 33.75 | 153.22 | not applicable |
1 (P) | 100 | 99.10 | 30.25 | 154.35 | 1.00 |
2 (P) | 200 | 96.10 | 29.75 | 165.61 | 1.08 |
4 (P) | 400 | 105.11 | 32.25 | 135.09 | 0.88 |
5 (P) | 500 | 94.29 | 31.75 | 188.73 | 1.23 |
6 (P) | 600 | 92.49 | 27.50 | 166.68 | 1.08 |
10 (P) | 800 | 73.27 | 12.50 | 110.61 | 0.72 |
13 (P) | 925 | 46.25 | 6.75 | 113.79 | 0.74 |
14 (P) | 1000 | 1.80 | 0.25 | 132.46 | 0.86 |
B[aIP | 3.5 | 94.29 | 70.25 | 618.47 | 4.02 |
*Based on 4 plates
NC: Negative Control
(P): Precipitation
B[a]P: Benz(a)pyrene
Colony Sizing, with metabolic activation (see Table 11 in original study report)
Test Group | Concentration (ug/mL) | Quotient Large/Small |
NC1 | 0 | 4.43 |
NC2 | 0 | 3.5 |
6 (P) | 600 | 3.23 |
10 (P) | 800 | 1.94 |
13 (P) | 925 | 1.25 |
14 (P) | 1000 | n.c |
8[a)P | 3.5 | 0.98 |
NC: Negative Control
(P): Precipitation
B[a]P: Benz(a)pyrene
RESULTS WITHOUT METABOLIC ACTIVATION - Experiment II (long-term exposure)
Mutagenicity Data without metabolic activation (see Table 14 in original study report)
Test Group | Concentration (ug/mL) | RCE (%) | Mean* Number of Cultures/96 wells | Mutants/10^6 cells (Mutation Frequency) | Mutation factor |
NC1 | 0 | 100.00 | 24.50 | 131.56 | not applicable |
NC2 | 0 | 100.00 | 28.25 | 189.25 | not applicable |
1 |
0.5 | 107.79 | 28.25 | 139.45 | 0.87 |
2 |
1 |
101.30 | 30.25 | 180.88 | 1.13 |
3 (P) | 2 | 90.91 | 27.25 | 204.48 | 1.27 |
4 (P) | 5 | 92.21 | 28.50 | 209.43 | 1.31 |
5 (P) | 10 | 104.55 | 23.50 | 123.17 | 0.77 |
6 (P) | 20 | 106.49 | 25.75 | 129.76 | 0.81 |
7 (P) | 40 | 89.61 | 31.25 | 248.36 | 1.55 |
8 (P) | 80 | 85.71 | 28.50 | 242.25 | 1.51 |
EMS | 200 | 55.84 | 87.75 | 3304.92 | 20.60 |
MMS | 10 | 48.70 | 75.00 | 2454.69 | 15.30 |
*Based on 4 plates
NC: Negative Control
(P): Precipitation
EMS: Ethylmethanesulfonate
MMS: Methylmethanesulfonate
Colony Sizing, without metabolic activation (see Table 15 in original study report)
Test Group | Concentration (ug/mL) | Quotient Large/Small |
NC1 | 0 | 3.08 |
NC2 | 0 | 3.52 |
6 (P) | 20 | 3.9 |
7 (P) | 40 | 3.63 |
8 (P) | 80 | 1.53 |
MMS | 10 | 0.73 |
NC: Negative Control
(P): Precipitation
MMS: Methylmethanesulfonate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative non-mutagenic in the mouse lymphoma thymidine kinase locus
In conclusion, in the described mutagenicity test under the experimental conditions reported, the test item Nickel matte (N123) is considered to be non-mutagenic in the mouse lymphoma thymidine kinase locus using the cell line L5178Y. - Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER
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