2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1986-10-17 to 1988-05-17

Reliability:

2 (reliable with restrictions)

Data source

Reference

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1983

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

EC Number:

264-980-3

EC Name:

2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

Cas Number:

64628-44-0

Molecular formula:

C15H10ClF3N2O3

IUPAC Name:

3-(2-chlorobenzoyl)-1-[4-(trifluoromethoxy)phenyl]urea

Test material form:

solid

Method

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

100, 500, 2500, 5000, 10,000 µg per plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other:

Details on test system and experimental conditions:

Plating Procedures for the Mutagenicity Assay Serial dilutions of the test article will be prepared immediately prior to the mutagenicity assay. S9-mix will also be prepared immediately prior to its use in the mutagenicity assay.
At least five doses of the test article will be plated with the appropriate tester strains, both with, and without metabolic activation. Without metabolic activation, 100 µL of tester strain and 50 µL of vehicle or test article will be added to 2.5 mL of molten selective top agar at 45 ± 2°C.
With metabolic activation, 100 µL of tester strain, 50 µL of solvent or test article solution and 0.5 µL of S9-mix will be added to 2.0 mL of molten selective top agar at 45 ± 2°C. After vortexing, the mixture will be overlaid onto the surface of 25 mL of minimal bottom agar. After the overlay has solidified, the plates will be inverted and incubated for approximately 48 hours at 37 ± 2°C. When necessary, aliquots of other than 50 µL of test article/vehicle will be plated.

Evaluation criteria:

For a test article to be considered positive, it must cause at least a doubling in the mean revertants per plate of at least one tester strain. This increase in the mean number, of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article. If the study is to be judged positive solely on the basis of a dose-responsive, less than 3-fold increase on TA1537 or TA1538, the response must be confirmed in a repeat experiment.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive 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:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Triflumuron was non-mutagenic with and without metabolic activation in the Salmonella/microsome assay.

Executive summary:

The results of the Salmonella/Mammalian-Microsome Plate Incorporation Mutagenicity Assay indicate that under the conditions of this study, at 10000, 5000, 2500, 500 and 100 µg per plate, the test item did not cause a positive response on any of the tester strains with or without metabolic activation by Aroclor induced rat liver microsomes. There were no increases in the number of revertants per plate on any of the tester strains in either the presence or absence of metabolic activation.