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EC number: 949-694-5 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 August 1995 - 25 September 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Version / remarks:
- 1983.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 92/69/EEC, Method B.14
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2)
- EC Number:
- 949-694-5
- Molecular formula:
- Mg2.7K0.7Si4O10F2
- IUPAC Name:
- Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2)
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Nonswellable mica MK (Micromica), supplied by Co-op Chemical Co., Ltd.
Lot No,. 637.
Method
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 applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- S9 obtained from the livers of male CD rats, 4 days after administration of a single intraperitoneal injection of Aroclor 1254.
- Supernatant from liver homogenate formed 1 mL out of total 12.1 mL S9 mix.
- 0.5 mL of S9 mix was added to the agar mix for the plate-incorporation assays. - Test concentrations with justification for top dose:
- 50, 158, 500, 1580, 5000 μg/plate.
Top dose is limit concentration for this assay. - Vehicle / solvent:
- Plate incorporation test: Micromica was mixed with 0.15% aqueous agar.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Dilution of bacterial culture plated on nutrient agar.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.15% aqueous agar only (with and without S9 mix)
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- 9-aminoacridine, TA1537 without S9. 2-nitrofluorene, TA98, without S9. Sodium azide, TA100 and TA1535, without S9. ENNG, E. coli, without S9. B(a)p, TA98, TA100 and TA1537, with and without S9. 2-AA, TA1535 and E. coli, with and without S9.
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: all plates were prepared in triplicate.
- Number of independent experiments: two.
FOR GENE MUTATION:
- Expression time (cells in growth medium between treatment and selection): 2 days.
- Method used: agar plate-incorporation.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method,: background growth inhibition - Evaluation criteria:
- Not specified.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In a guideline bacterial reverse mutation test, magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) gave no evidence of mutagenic activity in five strains of bacteria in the presence and absence of S9.
- Executive summary:
The mutagenicity of magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) was evaluated in a bacterial reverse mutation (Ames) assay, conducted according to OECD Test Guideline 471 and to GLP, using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537, and Escherichia coli strain WP2uvrA. The substance was tested by plate-incorporation up to the limit concentration of 5000 μg/plate, in the presence and absence of a rat liver-derived metabolic activation fraction (S9). There were no increases in revertant colony numbers over controls with any tested strains at any tested concentrations. Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) was therefore concluded to be non-mutagenic.
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