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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation. Lacked information on the purity of the test substance and study was conducted with only a single bacterial strain.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Study of the mutagenicity of metal derivatives with Salmonella typhimurium TA102.
Author:
Marzin, D.R. and H.V. Phi
Year:
1985
Bibliographic source:
Mutation Research. 155(1/2):49-51.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Maron and Ames
Principles of method if other than guideline:
Mutagenicity assay, conducted as described by Maron and Ames (1983) in the Ames plate-incorporation test.  
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nickel nitrate
- 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
- Other details not reported or not applicable

Method

Target gene:
not applicable
Species / strain
Species / strain / cell type:
S. typhimurium TA 102
Details on mammalian cell type (if applicable):
not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
without
Test concentrations with justification for top dose:
0, 10, 30, 100, 300, and 1000 nM/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: medium
Controls
Untreated negative controls:
yes
Remarks:
water
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
mitomycin C
Details on test system and experimental conditions:
METHOD OF APPLICATION:
S. typhimurium strain TA102 was obtained from Prof. B.N. Ames, University of California, Berkely.   
Results were generated as a mean of triplicate plates, with parallel negative (water) and positive (mitomycin c) controls.  
Test substance doses were a logarithmic series up to insolubility, or toxicity.  
The threshold toxic dose was determined to be that which decreased the estimated background bacterial lawn under microscopic examination.

OTHER: details not reported
Evaluation criteria:
Criteria for mutagenicity:
- dose/effect relationship observed,
- effect is reproducible, and
- number of revertants = 2 x number of spontaneous revertants.
Statistics:
Not reported

Results and discussion

Test results
Species / strain:
S. typhimurium TA 102
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
The test substance was determined not to be mutagenic to S. typhimurium strain TA102.  
The threshold toxic dose was reported to be 3000 nM/plate.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Nickel nitrate was determined not to be mutagenic to S. typhimurium strain TA102. 
Executive summary:

ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.

Mutagenicity assay, conducted as described by Maron and Ames (1983) in the Ames plate-incorporation test.  S. typhimurium strain TA102 was  

obtained from Prof. B.N. Ames, University of California, Berkely.  Results were generated as a mean of triplicate plates, with parallel  

negative (water) and positive (mitomycin c) controls.  Test substance doses were a logarithmic series up to insolubility, or toxicity.  The  

threshold toxic dose was determined to be that which decreased the estimated background bacterial lawn under microscopic examination.


Criteria for mutagenicity:
-dose/effect relationship observed,
-effect is reproducible, and
-number of revertants = 2 x number of spontaneous revertants.

The test substance was determined not to be mutagenic to S. typhimurium strain TA102.  The threshold toxic dose was reported to be 3000 nM/plate.

STUDY RATED BY AN INDEPENDENT REVIEWER.