ammonium 2,2,3 trifluor-3-(1,1,2,2,3,3-hexafluoro-3-trifluormethoxypropoxy), propionate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 February 2007 to 15 February 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

In the range finding test, the S9-fraction was 5.6% (v/v). Amount of the S9-fraction in the S9-mix was increased by 12% and positive and negative control data were within historical range for both tester strains.Deviation has no influence on test result

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: European Economic Community (EEC), Directive 2000/32/EC, Part B: Methods for the Determination of Toxicity; B. 13/14: "Mutagenicity: "Reverse Mutation Test using bacteria". EEC Publication Commission Directive (Published June 8, 2000).

Deviations:

yes

Remarks:

In the range finding test, the S9-fraction was 5.6% (v/v). Amount of the S9-fraction in the S9-mix was increased by 12% and positive and negative control data were within historical range for both tester strains.Deviation has no influence on test result

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): MTDID 6675
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Analytical purity: Formulation tested is 30.0% active ingredient in water
- Purity test date: 12/20/2005
- Lot/batch no.: 140499-8/25
- Expiration date of the lot/batch:02 July 2008
- Storage condition of test material: Refrigerated (2-8 degrees C) in the dark

Method

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA1535, TA1537, TA98, TA100, and Escherichia coli WP2uvrA.

Additional strain / cell type characteristics:

other: rfa: deep rough (defective lipopolysaccharide cellcoat) gal: mutation in the galactose metabolism chl: mutation in nitrate reductase bio: defective biotin synthesis uvrB: loss of the excision repair system (deletion of the ultraviolet-repair B gene)

Metabolic activation:

with and without

Metabolic activation system:

Rat liver microsomal enzymes were routinely prepared from adult male Wistar rats, which were obtained from Charles River, Sulzfel, Germany.

Test concentrations with justification for top dose:

100-5000 micrograms test article per plate.

Vehicle / solvent:

Vehicle(s)/solvent(s) used: None (test article was supplied as 30% active ingredient in water).

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: Without Metabolic Activation: TA1535: Sodium azide, TA1537: 9-aminoacridine, TA98: 2-nitrofluorene, TA100: methylemthanesulfonate, WP2uvrA: 4-nitroquinoline N-oxide. With Metabolic Activation: All Strains: 2-aminoanthracene.

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours of incubation time.
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA1535, TA1537, TA98, TA100, and Escherichia coli WP2uvrA.

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Based on the results of this study, the test article is not mutagenic in the Salmonella typhimurium reverse mutation assay and the Escherichia coli reverse mutation assay.

Executive summary:

The mutagenic activity of the test article (liquid, batch 140499-19/10) was evaluated in the Salmonella typhimurium reverse mutation assay (strains: TA1535, TA1537, TA98 and TA100, histidine-requiring) and the Escherichia coli reverse mutation assay (strain: WP2uvrA, tryptophan-requiring) in the presence and absence of a metabolic activation system (S9-mix: rat liver S9-mix induced by a combination of phenobarbital and ß naphthoflavone) following OECD guideline No. 471 “Genetic Toxicology: Bacterial Reverse Mutation Test” (adopted July 21, 1997). The test material was diluted in Milli-Q water resulting in a clear colorless liquid that was filter (22 µm) sterilized and used within 3 hours of preparation. A conversion factor for purity (29.9 ± 0.1% in water) was used in dose calculations. A dose rangefinder was performed using concentrations up to 5000 µg/plate of the test article in the presence and absence of 5.6% (v/v) S9-mix on S. typhimurium strain TA100 and E. coli strain WP2uvrA. The bacterial background lawn was not reduced and there was no biologically relevant decrease in the number of revertants which confirmed that this was an appropriate range of doses. The test article was then tested at 100 to 5000 µg/plate on S. typhimurium strains TA1535, TA1537 and TA98 in the presence and absence of 5% (v/v) S9-mix. An independent assay was performed at the same MTDID 6675 concentration range in the presence and absence of 10% (v/v) S9-mix on S. typhimurium strains TA1535, TA1537, TA98 and TA100 and E. coli strain WP2uvrA. The bacterial background lawn was not reduced and there was no biologically relevant decrease in the number of revertants in these assays. The test article did not precipitate on any plate in any assay. Negative control (Milli-Q water) and positive controls (strain specific) were included in each assay and the results indicated that the test conditions of each plate were adequate and the metabolic activation system functioned appropriately.The test article did not induce a significant dose-related increase in the number of revertant colonies in any of the tested strains both in the presence and absence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. Based on the results of this study,the test article is not mutagenic in the Salmonella typhimurium reverse mutation assay and the Escherichia coli reverse mutation assay.