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Diss Factsheets
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EC number: 242-522-3 | CAS number: 18718-11-1
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets generally accepted scientific standards with acceptable restrictions Study lacks information on replication. No positive control group included. No information on a vehicle (acetone) control. Only a single dose level used for chromosome aberration tests; no dose-response can be determined. No statistical evaluation of the data. Non-standard cell line used (embryo cells).
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:
- publication
- Title:
- Induction by inorganic metal salts of sister chromatid exchange and aberrations in human and Syrian hamster cell strains.
- Author:
- Larramendy, M.L., N.C. Popescu, and J.A. DiPaolo.
- Year:
- 1 981
- Bibliographic source:
- Environmental Mutagenesis. 2:597-606.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No standard guideline followed. Sister chromatid exchange assay and Chromosomal aberration test.
- GLP compliance:
- not specified
- Type of assay:
- other: Sister chromatid exchange assay and Chromosomal aberration test
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- Molecular formula:
- NiSO4
- IUPAC Name:
- nickel(2+) sulfate
- Reference substance name:
- Chemical Services, Inc., Westchester, PA, USA.
- IUPAC Name:
- Chemical Services, Inc., Westchester, PA, USA.
- Details on test material:
- - Name of test material (as cited in study report): Nickel Sulfate Hexahydrate, 10101-97-0
- Molecular formula (if other than submission substance): not different than submission substance
- Molecular weight (if other than submission substance): not different than submission substance
- Smiles notation (if other than submission substance): not different than submission substance
- InChl (if other than submission substance): not different than submission substance
- Structural formula attached as image file (if other than submission substance): not different than submission substance
- Purity: 97%
- Other details not reported or not applicable
Constituent 1
Constituent 2
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- other: Syrian hamster embryo cells and human lymphocyte cultures
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Hamster embryo cells were collected after trypsinization of the embryos minus the liver and plated (density of 10e7 cells/100 mm dish) in Dulbecco's modified Eagle's medium supplemented with 10% fetal bovine serum.
Other details not reported - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 0, 1.0, 2.5, 5.0 ug/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
Sister chromatid exchange (SCE) and chromosomal aberration tests were conducted with Syrian hamster embryo cells and human lymphocyte
cultures. Hamster embryo cells were collected after trypsinization of the embryos minus the liver and plated (density of 10e7 cells/100 mm dish)
in Dulbecco's modified Eagle's medium supplemented with 10% fetal bovine serum.
DURATION
Hamster embryo cells were incubated at 37 deg. C in an 11% CO2 air incubator. 24 hours later, monolayer cultures (10e6 cells/100 mm dish) were treated with nickel sulfate (prepared in acetone) and 10 ug BrdUrd/ml medium and incubated for 24 hours. Four hours prior to harvest, cells were treated with Colcemide (0.13 ug/ml), then collected, centrifuged, suspended in KCl, and fixed in methanol:glacial acetic acid.
For SCE tests, slides were prepared and stained with 4% Giemsa in Gurr's buffer solution. A minimum of 30 metaphases were scored. For
chromosome aberration tests, preparations were air dried and stained with Gurr's buffer solution and 5% Giemsa. At least 125 metaphases were
examined. Aberrations were scored per the International system for human cytogeneic nomenclature (1978).
For chromosome aberration tests, preparations were air dried and stained with Gurr's buffer solution and 5% Giemsa. At least 125 metaphases
were examined. - Evaluation criteria:
- Aberrations were scored per the International system for human cytogeneic nomenclature (1978).
- Statistics:
- Not reported
Results and discussion
Test results
- Species / strain:
- other: Syrian hamster embryo cells and human lymphocyte cultures
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not examined
- Additional information on results:
- NiSO4 increased the frequency of SCEs in hamster embryo cells in a dose dependent manner:
Hamster embryo cells [frequency of SCEs/metaphase (standard error)]:
BrdUrd control: 11.55 (0.84)
1.0 ug/ml: 15.95 (0.92)
2.5 ug/ml: 17.25 (1.44)
5.0 ug/ml: 21.25 (1.13)
NiSO4 also increased the number of chromosomal aberrations relative to the control:
Hamster embryo cells [percent cells with aberrations and mean aberrations/metaphase (standard error)]:
Control: 1.50%, 0.01 (0.01)
5.0 ug/ml: 16.50%, 0.16 (0.03) (Chromosomal aberrations noted in embryo cells included gaps, breaks, exchanges, and minutes) - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- NiSO4 was positive for chromosomal aberrations in Syrian hamster embryo cells.
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.
Robust Summary for Larramendy et al.(1981):
Sister chromatid exchange (SCE) and chromosomal aberration tests were conducted with Syrian hamster embryo cells and human lymphocyte cultures.
Hamster embryo cells were collected after trypsinization of the embryos minus the liver and plated (density of 10e7 cells/100 mm dish) in
Dulbecco's modified Eagle's medium supplemented with 10% fetal bovine serum. Hamster embryo cells were incubated at 37 deg. C in an 11% CO2
air incubator. 24 hours later, monolayer cultures (10e6 cells/100 mm dish) were treated with nickel sulfate (prepared in acetone) and 10 ug
BrdUrd/ml medium and incubated for 24 hours. Four hours prior to harvest, cells were treated with Colcemide (0.13 ug/ml), then collected,
centrifuged, suspended in KCl, and fixed in methanol:glacial acetic acid. For SCE tests, slides were prepared and stained with 4% Giemsa in Gurr's
buffer solution. A minimum of 30 metaphases were scored. For chromosome aberration tests, preparations were air dried and stained with Gurr's
buffer solution and 5% Giemsa. At least 125 metaphases were examined. Aberrations were scored per the International system for human cytogeneic
nomenclature (1978).
Human blood cultures were collected from healthy donors and diluted with Hank's balanced salt solution (without Ca and Mg). 0.5 ml of heparinizedblood was mixed with 9.5 ml of RPMI 1640 medium supplemented with 20% fetal bovine serum and 0.25 ml phytohemagglutinin M. Lymphocytes were
collected by centrifugation (400 rpm for 40 minutes), resuspended in complete medium, and then washed three times with Hank's balanced salt
solution. Lymphocytes were cultured in flasks at a density of 1.5 x 10e6 cells in 5 ml RPMI 1640 medium supplemented with 20% fetal bovine serum
and 0.1 ml phytohemagglutinin. 24 hours later, lymphocytes were treated with nickel sulfate (prepared in acetone) and 30 ug BrdUrd/ml medium and
incubated for 48 hours. Two hours prior to harvest, cells were treated with Colcemide (0.13 ug/ml), then collected, centrifuged, suspended in
KCl, and fixed in methanol:glacial acetic acid. For SCE tests, slides were prepared and stained with 4% Giemsa in Gurr's buffer solution. A
minimum of 30 metaphases were scored. For chromosome aberration tests, preparations were air dried and stained with Gurr's buffer solution and
5% Giemsa. At least 125 metaphases were examined. Aberrations were scored per the International system for human cytogeneic nomenclature (1978).
NiSO4 increased the frequency of SCEs in human lymphocytes and hamster embryo cells in a dose dependent manner:
Human lymphocytes [frequency of SCEs/metaphase (standard error)]:
BrdUrd control: 11.30 (0.60)
2.5 ug/ml: 17.20 (0.90)
5.0 ug/ml: 18.95 (1.52)
Hamster embryo cells [frequency of SCEs/metaphase (standard error)]:
BrdUrd control: 11.55 (0.84)
1.0 ug/ml: 15.95 (0.92)
2.5 ug/ml: 17.25 (1.44)
5.0 ug/ml: 21.25 (1.13)
NiSO4 also increased the number of chromosomal aberrations relative to the control:
Human lymphocytes [percent cells with aberrations and mean aberrations/metaphase (standard error)]:
Control: 1.50%, 0.01 (0.01)
5.0 ug/ml: 11.20%, 0.07 (0.02)
(Chromosomal aberrations noted in human lymphocytes included gaps, breaks, rings, and minutes)
Hamster embryo cells [percent cells with aberrations and mean aberrations/metaphase (standard error)]:
Control: 1.50%, 0.01 (0.01)
5.0 ug/ml: 16.50%, 0.16 (0.03)
(Chromosomal aberrations noted in embryo cells included gaps, breaks, exchanges, and minutes)
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