4-Methyl-N-[[[3-(trifluoromethyl)phenyl]amino]carbonyl] benzenesulfonamide

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:

9 August 2019 to 25 September 2019

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

2011

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-Methyl-N-[[[3-(trifluoromethyl)phenyl]amino]carbonyl] benzenesulfonamide

EC Number:

850-929-8

Cas Number:

1584-79-8

Molecular formula:

C15H13F3N2O3S

IUPAC Name:

4-Methyl-N-[[[3-(trifluoromethyl)phenyl]amino]carbonyl] benzenesulfonamide

Test material form:

solid

Method

Target gene:

Salmonella strains: Histidine
E. coli: Tryptophan

Species / strain

Species / strain 1

Species / strain / cell type:

E. coli WP2 uvr A

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9 Mix

Test concentrations with justification for top dose:

-S9 mix:
TA100, TA1535, TA1537: 39.1; 78.1; 156; 313; 625; 1500 µg/plate
WP2uvrA, TA98: 156; 313; 625; 1250; 2500; 5000 µg/plate
+S9 mix
TA100, TA1535, TA1537, WP2uvrA, TA98: 39.1; 78.1; 156; 313; 625; 1500 µg/plate

Vehicle / solvent:

DMSO

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

benzo(a)pyrene

furylfuramide

other: 2-Aminoanthracene

Remarks:

with and without activation

Details on test system and experimental conditions:

After 0.1 mL of the test item solution, vehicle or the positive control item solutions, 0.5 mL of 0.1 M sodium phosphate buffer or S9 mix and 0.1 mL of the bacterial culture were added to a test tube, the mixture was shaken at 37°C +/- 0.5°C for 20 minutes. Two milliliters of the soft agar were then added to each tube and the mixture was poured onto a minimal glucose agar plate. The number of revertant colonies was counted after incubation at 37°C +/- 0.5°C after 48 h.

Evaluation criteria:

The test item was judged to be positive when the number of revertant colonies increased to twice or more than that in the negative control and when the responses were dose-related and/or reproducible.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Untreated negative controls validity:

valid

True negative controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Test results 3

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Additional information on results:

Cytoxicity was observed for Salmonella strains at the limit concentration

Applicant's summary and conclusion

Conclusions:

It was concluded that the substance had no ability to induce mutations under the present test conditions.

Executive summary:

The mutagenicity of the test item was judged to be negative because the number of revertant colonies in the test item treatment groups was less than twice that in the negative control for all tester strains regardless of the presence or absence of S9 mix.