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EC number: 601-779-5 | CAS number: 121451-02-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 02 February 2001 - 02 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Japan MAFF Revised Mutagenicity Guidelines, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- EC Number:
- 601-779-5
- Cas Number:
- 121451-02-3
- Molecular formula:
- C17H7Cl2F9N2O3
- IUPAC Name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: White powder
- Storage condition of test material: Ambient temperature
Constituent 1
Method
- Target gene:
- Histidine and tryptophan loci.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The broth used to grow overnight cultures of the tester strains was Vogel- Bonner salt solution (Vogel and Bonner, 1956) supplemented with 2.5 % (w/v) Oxoid Nutrient Broth No. 2 (dry powder).
Bottom agar (25 mL per 15 x 100 mm petri dish) was Vogel- Bonner minimal medium E (Vogel and Bonner, 1956), supplemented with 1.5 % (w/v) agar and 0.2 % (w/v) glucose.
Top (overlay) agar was prepared with 0.7 % agar (w/v) and 0.5 % NaCl (w/v) and was supplemented with 10 mL of 1) 0.5 mM histidine/biotin solution per 100 mL agar for selection of histidine revertants, or 2) 0.5 mM tryptophan solution per 100 mL of agar for selection of tryptophan revertants. For an agar overlay, 2.0 mL of the supplemented top agar was used.
- Properly maintained: yes
- Periodically "cleansed" against high spontaneous background: yes
- Periodically checked for genotype: Tester strain cultures were checked for the following genetic markers on the day of their use in the mutagenicity assay; rfa Wall Mutation and pKM101 Plasmid. - Additional strain / cell type characteristics:
- other: All Salmonella typhimurium strains; uvrB and rfa. Salmonella typhimurium stains TA98 and TA100; pKM101. Escherichia coli WP2; uvrA.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Dose range finding assay: 6.67, 10, 33.3, 66.7, 100, 333, 667, 1000, 3330 and 5000 µg/plate
Mutagenicity assay: 33.3, 100 333, 1000, 3330 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene, ICR-191
- Details on test system and experimental conditions:
- Two independent assays were performed, an initial mutagenicity assay followed by a confirmation assay.
METHOD OF APPLICATION: preincubation method. S9 mix (or phosphate buffer, where appropriate), the tester strain, and the test article were preincubated prior to the addition of molten agar. The agar and the preincubation reaction mixture were mixed and then overlaid onto a minimal agar plate.
DURATION
- Preincubation period: 20 ± 2 minutes at 37 ± 2 °C.
- Exposure duration: 52 ± 4 hours at 37 ± 2 °C.
NUMBER OF REPLICATIONS: All concentrations of the test article, the vehicle controls and the positive controls were plated in triplicate.
REVERTANT COLONY COUNTING: The number of revertant colonies per plate for the vehicle controls and all plates containing test article were counted manually. The number of revertant colonies per plate for the positive controls were counted by automated colony counter.
DETERMINATION OF CYTOTOXICITY
- Method: Evidence of cytotoxicity was scored relative to the vehicle control plate and was recorded along with the revertant counts for all plates at that concentration level. Lawns were scored as 1) normal, 2) slightly reduced, 3) moderately reduced, 4) extremely reduced, 5) absent, or 6) obscured by precipitate. - Evaluation criteria:
- - Tester Strain TA100: For a test material to be considered positive, it had to produce at least a 2-fold dose related and reproducible increase in the mean revertants per plate over the mean revertants per plate of the appropriate vehicle control. A response that did not meet all three of the above criteria (magnitude, dose-responsiveness, reproducibility) was not evaluated as positive.
- Tester Strains TA98, TA1535, TA1537, and WP2uvrA: For a test material to be considered positive, it had to produce at least a 3-fold dose related and reproducible increase in the mean revertants per plate of at least one of these tester strains over the mean revertants per plate of the appropriate vehicle control. A response that did not meet all three of the above criteria (magnitude, dose-responsiveness, reproducibility) was not evaluated as positive.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Dose Rangefinding Assay
Cytotoxicity was observed with tester strain TA100 in the absence of S9 mix at the maximum concentration tested (5000 µg per plate) as evidenced by a concentration-related decrease in the number of revertants per plate. No cytotoxicity was observed with either tester strain TA100 in the presence of S9 mix, as evidenced by no concentration-related decrease in the number of revertants per plate and a normal bacterial background lawn. No cytotoxicity was observed with tester strain WP2uvrA in the presence or absence of S9 mix, as evidenced by no concentration-related decrease in the number of revertants per plate and a normal bacterial background lawn.
Mutagenicity Assay
In the initial mutagenicity assay, and in the confirmatory assay, all data were acceptable and no positive increases in the mean number of revertants per plate were observed with any of the tester strains in either the presence or absence of S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Mutagenicity Assay – Summary
Substance |
Concentration µg/plate |
Tester Strain |
Background Lawn* |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
||||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|||
With External Metabolic Activation System S9 mix |
||||||||||||
Vehicle Control |
27 |
8 |
111 |
8 |
18 |
3 |
9 |
2 |
25 |
5 |
1 |
|
Test Material |
33.3 |
26 |
7 |
91 |
4 |
14 |
2 |
8 |
4 |
34 |
5 |
1 |
100 |
29 |
7 |
109 |
7 |
13 |
2 |
11 |
5 |
26 |
3 |
1 |
|
333 |
32 |
4 |
98 |
5 |
16 |
2 |
9 |
1 |
27 |
2 |
1sp |
|
1000 |
31 |
4 |
106 |
5 |
13 |
2 |
8 |
2 |
23 |
4 |
1sp |
|
3330 |
28 |
3 |
104 |
17 |
12 |
2 |
9 |
4 |
22 |
7 |
1sp |
|
5000 |
27 |
5 |
97 |
19 |
12 |
2 |
7 |
3 |
24 |
6 |
1mp |
|
Positive Control** |
373 |
32 |
809 |
69 |
136 |
7 |
116 |
13 |
422 |
78 |
1 |
|
Without External Metabolic Activation |
||||||||||||
Vehicle Control |
18 |
7 |
105 |
3 |
18 |
6 |
7 |
2 |
28 |
2 |
1 |
|
Test Material |
33.3 |
21 |
1 |
101 |
12 |
13 |
6 |
7 |
3 |
23 |
4 |
1 |
100 |
23 |
11 |
95 |
6 |
13 |
6 |
10 |
5 |
26 |
5 |
1 |
|
333 |
18 |
5 |
100 |
11 |
13 |
0 |
6 |
4 |
28 |
6 |
1sp |
|
1000 |
17 |
7 |
88 |
8 |
12 |
4 |
6 |
1 |
21 |
6 |
1mp |
|
3330 |
12 |
3 |
98 |
3 |
9 |
1 |
4 |
2 |
16 |
4 |
1mp |
|
5000 |
13 |
0 |
86 |
16 |
13 |
1 |
6 |
1 |
18 |
4 |
1mp |
|
Positive Control*** |
367 |
32 |
687 |
42 |
559 |
20 |
1170 |
63 |
545 |
28 |
1 |
Table 2: Confirmation Mutagenicity Assay – Summary
Substance |
Concentration µg/plate |
Tester Strain |
Background Lawn* |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
||||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|||
With External Metabolic Activation System S9 mix |
||||||||||||
Vehicle Control |
33 |
4 |
108 |
7 |
14 |
3 |
11 |
1 |
23 |
4 |
1 |
|
Test Material |
33.3 |
33 |
2 |
123 |
5 |
10 |
5 |
8 |
1 |
22 |
2 |
1 |
100 |
31 |
3 |
115 |
17 |
13 |
3 |
9 |
5 |
22 |
7 |
1 |
|
333 |
30 |
8 |
108 |
10 |
14 |
2 |
9 |
2 |
29 |
4 |
1sp |
|
1000 |
38 |
7 |
113 |
10 |
13 |
1 |
4 |
1 |
22 |
4 |
1sp |
|
3330 |
27 |
3 |
118 |
12 |
11 |
3 |
6 |
2 |
15 |
8 |
1mp |
|
5000 |
31 |
5 |
128 |
5 |
13 |
2 |
7 |
3 |
13 |
2 |
1mp |
|
Positive Control** |
371 |
52 |
1016 |
32 |
121 |
2 |
117 |
15 |
494 |
28 |
1 |
|
Without External Metabolic Activation |
||||||||||||
Vehicle Control |
17 |
7 |
106 |
3 |
13 |
6 |
7 |
3 |
17 |
6 |
1 |
|
Test Material |
33.3 |
27 |
4 |
116 |
14 |
13 |
2 |
4 |
1 |
13 |
6 |
1 |
100 |
24 |
3 |
105 |
1 |
11 |
3 |
6 |
3 |
24 |
11 |
1 |
|
333 |
21 |
4 |
101 |
7 |
14 |
3 |
5 |
1 |
21 |
3 |
1sp |
|
1000 |
22 |
10 |
103 |
6 |
10 |
2 |
6 |
2 |
17 |
2 |
1sp |
|
3330 |
23 |
7 |
107 |
6 |
14 |
5 |
5 |
1 |
11 |
3 |
1mp |
|
5000 |
17 |
5 |
111 |
5 |
11 |
1 |
6 |
5 |
13 |
5 |
1mp |
|
Positive Control*** |
396 |
21 |
916 |
25 |
640 |
19 |
1828 |
19 |
351 |
23 |
1 |
Vehicle control DMSO 50 µL
** TA98, benzo[a]pyrene 2.5 µg/plate
TA100, 2-aminoanthracene 2.5 µg/plate
TA1535, 2-aminoanthracene 2.5 µg/plate
TA1537, 2-aminoanthracene 2.5 µg/plate
WP2uvrA, 2-aminoanthracene 25.0 µg/plate
*** TA98, 2-nitrofluorene 1.0 µg/plate
TA100, sodium azide 2.0 µg/plate
TA1535, sodium azide 2.0 µg/plate
TA1537, ICR-191 2.0 µg/plate
WP2uvrA, 4-nitroquinoline-N-oxide 0.4 µg/plate
* Background Lawn Evaluation Codes:
1 = normal; 2 = slightly reduced; 3 = moderately reduced; 4 = extremely reduced; 5 = absent; 6 = obscured by precipitate
sp = slight precipitate; mp = moderate precipitate (requires hand count); hp = heavy precipitate (requires hand count)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation
Under the conditions of the test, the test material did not cause a positive increase in the mean number of revertants per plate with any of the tester strains either in the presence or absence of S9 mix. The test material is therefore determined to be non-mutagenic in this assay. - Executive summary:
The genetic toxicity of the test material was determined in an in vitro bacterial reverse mutation assay, an ames test. The study was performed under GLP conditions and in accordance with the standardised guidelines OECD 471, EPA OPPTS 870.5100 and Japan MAFF Revised Mutagenicity Guidelines.
The concentrations tested in the mutagenicity assay were selected based on the results of a dose range finding assay using tester strains TA100 and WP2uvrA and ten concentrations of test article ranging from 6.67 to 5000 µg per plate.
The tester strain used in the mutagenicity assay were Salmonella typhimurium tester strains TA98, TA100, TA 1535, and TA1537 and Escherichia coli tester strain WP2uvrA. The assay was conducted with six concentration levels of test article in both the presence and absence of S9 mix along with concurrent vehicle and positive controls using three plates per concentration. The concentrations tested were 33.3, 100, 333, 1000, 3330, and 5000 µg per plate in both the presence and absence of S9 mix. The results of the initial mutagenicity assay were confirmed in the independent experiment.
Under the conditions of the test, the test material did not cause a positive increase in the mean number of revertants per plate with any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor™ induced rat liver (S9). The test material is therefore determined to be non-mutagenic in this assay.
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