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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Refer chapter 13 for detailed read across justification.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Test material was obtained from Fisher Scientific Co., Fair Lawn, NJ (U.S.A.);

Method

Target gene:
Histidine auxotrophic strains of S. typhimurium
Species / strain
Species / strain / cell type:
other: TA1535, TA100, TA1538, TA98 and TA1537
Details on mammalian cell type (if applicable):
provided by Dr. B.N. Ames, University of California, Berkeley, CA (U.S.A.). Two 1535 strains with different histories were used: TA1535 A obtained in 1973 and TA1535 B obtained in 1977.
Metabolic activation:
with and without
Metabolic activation system:
S9 liver fraction from Aroclor-pretreated rats.
Test concentrations with justification for top dose:
5 doses, up to 3600 µg/plate
Vehicle / solvent:
Not specified
Controls
Untreated negative controls:
not specified
Details on test system and experimental conditions:
The substance was tested on 2 slightly different minimal media: one (in the following named ZLM medium) is a modified minimal medium for E. coli , and the other is the Vogel-Bonner (VB) medium. ZLM medium contained (in g/l): tri-Nacitrate. 2H20 (0.82), K2HPO4-3H20 (4.60), KH2PO 4 (1.50), (NH4)2SO 4 (1.00), MgSO4.7H20 (0.10) and glucose (17.0). The concentration of citrate was 3.5 times higher in VB medium than in ZLM medium. The concentrations of the other ions are up to 2-fold higher in VB medium.
Evaluation criteria:
Not specified
Statistics:
Not specified

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and 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
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and 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
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and 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
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and 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
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and 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

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Sodium hexafluorosilicate was found to have no mutagenic potential in the bacterial reverse mutation assay.
Executive summary:

Sodium hexafluorosilicate was evaluated for the mutagenic potential in a bacterial reverse mutation assay. 5 tester strains of Salmonella typhimurium designated TA1535, TA100, TA1538, TA98 and TA1537, provided by Dr. B.N. Ames, University of California, Berkeley, CA (U.S.A.); were used. Two 1535 strains with different histories, TA1535 A obtained in 1973 and TA1535 B obtained in 1977, were also used for the testing. Tests were performed using 5 doses, up to 3600 µg/plate, in all 5 strains with and without activation by the S9 liver fraction from Aroclor-pretreated rats. No reverse mutations were observed with any of the tested strains. Hence, sodium hexafluorosilicate can be considered to be not mutagenic in this bacterial reverse mutation assay.