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EC number: 208-933-7 | CAS number: 547-67-1
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:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets generally accepted scientific standards with acceptable restrictions. The 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).
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 ML, Popescu NC, and DiPaolo JA
- 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 hexahydrate
- IUPAC Name:
- Nickel sulphate hexahydrate
- Reference substance name:
- 10101-97-0
- EC Number:
- 600-152-3
- Cas Number:
- 10101-97-0
- IUPAC Name:
- 10101-97-0
- Details on test material:
- - Name of test material (as cited in study report): Nickel sulphate hexahydrate (10101-97-0)
- Molecular formula (if other than submission substance): NiO4S.6H2O
- Molecular weight (if other than submission substance): 333.083
- Smiles notation (if other than submission substance): S(=O)(=O)([O-])[O-].[Ni+2]
- InChl (if other than submission substance): InChI=1/Ni.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)/q+2;/p-2
- 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.
- 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 10E+07 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 (10E+06 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 Colcemid (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 cytogenetic 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:
- no data
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'.
Any other information on results incl. tables
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)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Nickel sulphate induced genotoxicity in rat lung tissue after 90 day inhalation exposures of >=1.0 mg NiSO4/m3.
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