Registration Dossier
Registration Dossier
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EC number: 241-034-8 | CAS number: 16961-83-4
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published studies: screening data for a number of metal compounds, limited reporting, non-standard method
Data source
Reference
- Reference Type:
- publication
- Title:
- Rec assay mutagenicity studies on metal compounds
- Author:
- Kanematsu N, Hara M, & Kad T
- Year:
- 1 980
- Bibliographic source:
- Mutation Research, 77(2): 109-16
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Test for reverse bacterial mutation according to Ames (1975); spot test and liquid pre-incubation assay using strains of S. typhimurium and E. coli.
- GLP compliance:
- no
- Remarks:
- : older, published study
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium hexafluorosilicate
- IUPAC Name:
- Sodium hexafluorosilicate
- Details on test material:
- Sodium hexafluorosilicate; stated to be the highest purity commercially available
Constituent 1
Method
- Target gene:
- Various: reversion to histidine independence
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA 1538
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- without
- Metabolic activation system:
- not used
- Test concentrations with justification for top dose:
- Between 0.001- 10 M
Controls
- Untreated negative controls:
- yes
- Remarks:
- other metal compounds used in the screening assay gave negative results
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: other metal compounds used in the screening assay gave positive results
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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, other: 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
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
No evidence of reverse mutation was seen under the conditions of the study. The sensitivity of the assay was confirmed by positive results with some of the compounds screened, which are known mutagens.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative without metabolic activation
No evidence of reverse mutation was seen under the conditions of the study. - Executive summary:
The mutagenicity of a number of metal compounds was investigated in bacterial screening studies. No evidence of mutagenicity was seen with sodium hexafluorosilicate (without metabolic activation) in screening assays in S. typhimurium TA98, TA100, TA1535, TA1537 and TA1538) and E. coli WP2 strains. The absence of metabolic activation is not considered to affect the integrity of the study as the substance is unlikely to be subject to biotransformation. The sensitivity of the assay is confirmed by positive responses to some known chemical mutagens also screened in this study.
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