Methylium, triphenyl-, tetrakis(pentafluorophenyl)borate(1-).

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:

22 September - 2 October 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

21 July 1997

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Version / remarks:

8 June 2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

472-690-5

EC Name:

-

Cas Number:

136040-19-2

Molecular formula:

C24BF20.C19H15

IUPAC Name:

Methylium, triphenyl-, tetrakis(pentafluorophenyl)borate(1-).

Test material form:

solid: particulate/powder

Method

Target gene:

histidine

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:

Type and composition of metabolic activation system:
- source of S9 : rat liver microsomal enzymes were routinely prepared from adult male Wistar rats (Charles River, Sulzfeld, Germany)
- concentration or volume of S9 mix and S9 in the final culture medium : 5% or 10% (v/v)
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): all S9 batches were characterized with the metabolic activation requiring positive control benzo[a]pyrene in TA98 at 5 ug/plate.

Test concentrations with justification for top dose:

Dose range finding test with all strains: 3-10-33-100-333-1000-3330-5000 ug/plate in the absence and presence of S9.
Precipiation was observed in the dose range finder at 1000 ug/plate and above, toxicity in the absence of S9 at 100 ug/plate and above (TA100) or 333 ug/plate and above (WP2uvrA), toxicity in the presence of S9 at 1000 ug/plate and above (TA100 and WP2uvrA).
Mutation test 1 with TA98, TA1535, TA1537: 0.3-1-3-10-33-100-333 ug/plate in the absence of S9; 3-10-33-100-333-1000 ug/plate in the presence of S9.
Mutation test 2 with TA98, TA100, TA1535, TA1537: 0.3-1-3-10-33-100 ug/plate in the absence of S9; 3-10-33-100-333-1000 ug/plate in the presence of S9.
Mutation test 2 with WP2uvrA: 1-3-10-33-100-333 ug/plate in the absence of S9; 3-10-33-100-333-1000 ug/plate in the presence of S9.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO. Test substance concentrations were used within 4 hours after preparation.

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

2-nitrofluorene

sodium azide

methylmethanesulfonate

other: 2-aminoanthracene

Details on test system and experimental conditions:

All concentrations were tested in triplicate.

Evaluation criteria:

A test substance is considered negative (not mutagenic) in the test if:
a) the total number of revertants in TA100 is not greater than 2 times the concurrent control, and the total number of revertants in the other tester strains is not greater than 3 times the concurrent control.
b) the negative response should be reproducible in at least one independently repeated experiment.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

precipitation @ 1000 ug

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

@100 and 333 ug without S9, @1000 ug with S9

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

precipitation @ 1000 ug

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

@100 and 333 ug without S9, @1000 ug with S9

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

precipitation @ 1000 ug

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

@100 ug without S9, @1000 ug with S9

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

precipitation @ 1000 ug

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

@100 and 333 ug without S9, @1000 ug with S9

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

precipitation @ 1000 ug

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

@ 100 and 333 ug without S9

Applicant's summary and conclusion

Conclusions:

All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments. The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Based on the results of the study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.