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Diss Factsheets

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:
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:
1995
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

Constituent 1
Chemical structure
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
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.