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Registration Dossier
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EC number: 232-104-9 | CAS number: 7786-81-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of metal ions in bacteria.
- Author:
- Arlauskas, A., R.S.U. Baker, A.M. Bonin, R.K. Tandon, P.T. Crisp, and J. Ellis.
- Year:
- 1 985
- Bibliographic source:
- Environmental Research. 36:379-388.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Ames Test
- Principles of method if other than guideline:
- According to Ames et al. 1975
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
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:
- Ajax
- IUPAC Name:
- Ajax
- Details on test material:
- - Name of test material (as cited in study report): Nickel sulphate
- 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
- Substance type: Pure product
- Physical state: Liquid
- Analytical purity: analytical reagent grade
- Other details on test material not reported or not applicable
Constituent 1
Constituent 2
Method
- Target gene:
- Reverse mutation
Species / strain
- Species / strain / cell type:
- other: S. typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 and E.Coli strain (DG1153)
- Details on mammalian cell type (if applicable):
- S. typhimurium strains were obtained from Prof. B.N. Ames, University of California (Berkeley).
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- without
- Metabolic activation system:
- not applicable
- Test concentrations with justification for top dose:
- not reported
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Double distilled water
- Justification for choice of solvent/vehicle: not reported
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: The plate incorporation assay was used, plastic petri dishes were filled with 25 ml autoclave
sterilised minimal glucose agar medium.
DURATION
- Preincubation period: not reported
- Exposure duration: Plates were incubated at 37 deg. C for 3-5 days.
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not reported
SELECTION AGENT (mutation assays): not reported
NUMBER OF REPLICATIONS: The assay was repeated at least once.
NUMBER OF CELLS EVALUATED: not reported
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
OTHER EXAMINATIONS:
- Other: Plates were microscopically examined and the numbers of revertant colonies were counted. - Evaluation criteria:
- The criteria for positive results were based on Ames, et al. (1975) and de Serres and Shelby (1979).
Criteria included (1) a reproducible, dose-related increase in the number of revertant colonies and
(2) a doubling of colony numbers on test plates compared with background control plates. - Statistics:
- Chi square test
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- 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:
- not specified
- Species / strain:
- S. typhimurium TA 100
- 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:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- 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:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- 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:
- not specified
- Species / strain:
- S. typhimurium TA 1538
- 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:
- not specified
- Species / strain:
- E. coli, other:
- 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:
- not specified
- Additional information on results:
- Nickel sulfate was found not to be mutagenic.
TEST-SPECIFIC CONFOUNDING FACTORS: No data
RANGE-FINDING/SCREENING STUDIES: No data
COMPARISON WITH HISTORICAL CONTROL DATA: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Nickel sulphate was found not to be mutagenic in the reverse mutation assay using S. typhimurium strains.
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.
Robust summary for Arlauskas et al. (1985):
S. typhimurium strains were obtained from Prof. B.N. Ames, University of California (Berkeley). The plate incorporation assay was used. Plateswere incubated at 37 deg. C for 3-5 days. Plates were microscopically examined and the numbers of revertant colonies were counted. The assay
was repeated at least once.
The criteria for positive results were based on Ames, et al. (1975) and de Serres and Shelby (1979). Criteria included (1) a reproducible,dose-related increase in the number of revertant colonies and (2) a doubling of colony numbers on test plates compared with background control plates.
Nickel sulphate was found not to be mutagenic in the reverse mutation assay using S. typhimurium strains.
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