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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, published in peer-reviewed literature, minor restrictions in reporting, but otherwise acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
The results of microbial mutation test for forty-three industrial chemicals
Author:
Shimizu H, Suzuki Y, Takemura N, Goto S, Matsushita H
Year:
1985
Bibliographic source:
Jpn. J. Ind. Health, 27, 400-419

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): tetrafluoroboric acid
- Molecular formula (if other than submission substance): HBF4
- Analytical purity: 42%

Method

Species / strainopen allclose all
Species / strain / cell type:
other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
polychlorinated biphenyl induced rat liver S9-mix
Test concentrations with justification for top dose:
1, 5, 10, 50, 100, 500, 1000 and 5000 μg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)
Remarks:
strains TA 100, TA 98 and WP 2 uvrA, without S9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
strain TA 1535, without S9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
strain TA 1537, without S9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
strain TA 1538, without S9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
strains TA 100, TA 98, TA 1537 and TA 1538, with S9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
strains TA 1535 and WP 2 uvrA, with S9 mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes
- Incubation period: 48 hours

NUMBER OF REPLICATIONS: duplicate

DETERMINATION OF CYTOTOXICITY
- Method: background lawn

Results and discussion

Test resultsopen allclose all
Species / strain:
other: TA98, TA100, TA1535, TA1537 and TA1538
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
Positive controls validity:
valid
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
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The test substance is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Executive summary:

An Ames test with Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 and Escherichia coli strain WP2uvrA was performed with tetrafluoroboric acid (42% aqueous solution). The study was conducted according to the Guidelines of the Japanese Ministry of Labour. The strains were treated with test concentrations ranging from 1 to 5000 μg/plate, both in the presence and absence of metabolic activation. No increased number of revertants was observed in any case. Based on the results, the substance was concluded to give negative results in the Ames test.