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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:
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

Constituent 1
Chemical structure
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 resultsopen allclose all
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
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
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
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
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.