Nickel difluoride

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:

1985

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

Test material information

Constituent 1

Reference substance name:

Nickel ions

IUPAC Name:

Nickel ions

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

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 results

Species / strain:

other: S. typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538, and E.Coli

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: not reported

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

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.  Plates  

were 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.