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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
Bacillus subtilis recombination assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium tetrafluoroborate
EC Number:
237-340-6
EC Name:
Sodium tetrafluoroborate
Cas Number:
13755-29-8
Molecular formula:
NaBF4
IUPAC Name:
sodium tetrafluoroborate
Test material form:
solid

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
liver S9 fraction from rats pre-treated with phenobarbital and 5,6-benzoflavone
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Sterile water for injection (Baxter, batches 17D2705 and 16E0902). Dimethylsulfoxide (DMSO) (Honeywell, batch H012S).
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
methylmethanesulfonate
other: 2-Aminoanthracene
Evaluation criteria:
The assay was considered valid if the following criteria were met:
1. Mean plate counts for untreated and positive control plates should fall within 2 standard deviations of the current historical mean values.
2. The estimated numbers of viable bacteria/plate should fall in the range of 100 – 500 millions for each strain.
3. No more than 5% of the plates should be lost through contamination or other unforeseen event.

For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels.

Results show that mean plate counts for untreated and positive control plates fell within the normal range based on historical control data.
The estimated numbers of viable bacteria/plate (titre) fell in the range of 100 - 500 million for each strain. No plates were lost through contamination or cracking. The study was accepted as valid.
The test item did not induce two-fold increases in the number of revertant colonies, at any dose level, in any tester strain, in the absence or presence of S9 metabolism

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Vehicle controls validity:
not valid
Untreated negative controls validity:
not valid
Positive controls validity:
not valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Vehicle controls validity:
not valid
Untreated negative controls validity:
not valid
Positive controls validity:
not valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Vehicle controls validity:
not valid
Untreated negative controls validity:
not valid
Positive controls validity:
not valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Vehicle controls validity:
not valid
Untreated negative controls validity:
not valid
Positive controls validity:
not valid
Key result
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Vehicle controls validity:
not valid
Untreated negative controls validity:
not valid
Positive controls validity:
not valid
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Conclusions:
It is concluded that the test item SODIUM TETRAFLUOROBORATE does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9
metabolism, under the reported experimental conditions.