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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

in vitro gene mutation study in bacteria
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference Type:

Materials and methods

Test guideline
according to guideline
other: Ames test
Principles of method if other than guideline:
According to Ames et al. 1975
GLP compliance:
not specified
Type of assay:
other: bacterial reverse mutation assay

Test material

Chemical structure
Reference substance name:
Nickel sulphate
EC Number:
EC Name:
Nickel sulphate
Cas Number:
Molecular formula:
Nickel (II)sulphate
Specific details on test material used for the study:
Stock solutions of chemicals were prepared at 0.1 or 0.01 M concentrations in double glass-distilled water, sterilized by membrane filtration, and held in sealed glass bottles at room temperature. Aliquots of these stock solutions were used for mutagenicity assays at nontoxic concentrations. At the time of assay, serial half-log dilulions of each test chemical were prepared in distilled water.


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)
Salmonella strains TA98, TA100, TA1535, TA1537, and TA1538 wete obtained from Professor B. N. Ames and The E. coli strain (DG1153) was obtained from Dr. D. G. MacPhee (La Trobe University)
Vehicle / solvent:
Double distilled water
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
PLATE INCORPORATION ASSAY: Plastic petri dishes were filled with 25 ml autoclave sterilised minimal glucose agar medium. lnto each 2 ml of top agar was added 100 uL of the appropriate Salmonella strain from an ovemight broth culture, followed by 100 uL of test chemical, prepared in serial half·log worklng dilutions. The top agar was mixed and poured over the surface of a minimal agar plate. After the agar had set, plates were inverted and incubated at 37'C for 3-5 days. Unless stated otherwise, assay results ate those from plates incubated for 3 days. Colony numbers were determined manually and plates were examined microscopically for evidence of lawn toxicity and for colony appearance. Each assay was repeated at least once.
FLUCTUATION ASSAY: The microtiter fluctuation test was petformed according to the rnethod of Gatehouse (1978). Test chemical dilutions were added to 20-ml aroounts of prepared medium, to give the required final dilutlon. Then 1 ml of a 1/10 dilution of 3- to 4-hr broth cultures of bacteria was added in each 20-ml test or control bottle, which was mixed and dispensed in 0.2-ml amounts into the 96 wells of Linbro/Titertek trays (Flow Laboratoties). Trays with Iids were tightly wrapped in plastlc to minimize evaporation and incubated at 37°C for 3 days. To determine bacterial growth, 20 uL of bromothymol blue (600 ug/ml) was added to each well: negative wells appeared blue-green and positive wells appeared ye!low. Where metals affected the color of the indicator dye, wells were assessed for turbidity, based on absorbance measurements in a MicroELISA Auto Reader (Dynatech Model MR580) at 630 nm.
Evaluation criteria:
The criteria for positive results were based on Ames, et al. (1975) and de Serres and Shelby (1979) and 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.
x2 test

Results and discussion

Test results
Key result
Species / strain:
other: S. typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 and E.Coli strain (DG1153)
Metabolic activation:
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.
Remarks on result:
other: all strains tested

Applicant's summary and conclusion

Nickel sulphate was found not to be mutagenic in the reverse mutation assay using S. typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 and E.Coli strain (DG1153).