Potassium tetrafluoroborate

Genetic toxicity: in vitro

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Tetrafluoroboric acid

EC Number:

240-898-3

EC Name:

Tetrafluoroboric acid

Cas Number:

16872-11-0

IUPAC Name:

tetrafluoroborate

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 / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Species / strain 2

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

Controls

Controls 1

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

Controls 2

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

Controls 3

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

Controls 4

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

Controls 5

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

Controls 6

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 results

Test results 1

Species / strain:

S. typhimurium, 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

Test results 2

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.