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EC number: 938-115-1 | CAS number: 94720-90-8
- 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:
- 13 July 2012 - 3 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of (1R)-1,2,2-trichloro-2-fluoroethyl trifluoromethyl ether and (1S)-1,2,2-trichloro-2-fluoroethyl trifluoromethyl ether
- EC Number:
- 938-115-1
- Cas Number:
- 94720-90-8
- Molecular formula:
- C3HCl3F4O
- IUPAC Name:
- Reaction mass of (1R)-1,2,2-trichloro-2-fluoroethyl trifluoromethyl ether and (1S)-1,2,2-trichloro-2-fluoroethyl trifluoromethyl ether
- Test material form:
- liquid
- Details on test material:
- - Description: colourless liquid
- Batch 02072012
Constituent 1
Method
- Target gene:
- Reverse mutation assays employ bacterial strains which are already mutant at a locus whose phenotypic effects are easily detected.
The Salmonella tester strains have mutations causing dependence on a particular amino acid (histidine) for growth. The ability of test items to cause reverse mutations (reversions) to histidine-independence can easily be measured.
The E. coli tester strains of the WP2 series are similarly mutant at the tryptophan locus.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 tissue fraction from rat liver induced by Phenobarbital and 5,6-Benzoflavone
- Test concentrations with justification for top dose:
- A preliminary experiment ("toxicity test") was conducted at the maximum recommended dose levels to define the dose leeves for the main first experiment. This assay was conducted at the following dose levels:
All the strains, with and without S9: 5000 - 1580 - 500 - 158 and 50 µg/plate
On the basis of the cytotoxicity obtained in the preliminary toxicity test, the first main assay ("Main Assay I"), using the plate incorporation method, was conducted at the following dose levels:
TA1535, without S9: 500 - 250 - 125 - 62.5 and 31.3 µg/plate
TA1535, with S9: 2000 - 1000 - 500 - 250 - 125 and 62.5 µg/plate
TA1537, with and without S9: 1000 - 500 - 250 - 125 - 62.5 and 31..3 µg/plate
TA98, without S9: 2000 - 1000 - 500 - 250 - 125 and 62.5 µg/plate
TA98, with S9: 2000 - 1000 - 500 - 250 and 125 µg/plate
TA100, without S9: 1000 - 500 - 250 - 125 and 62.5 µg/plate
TA100 with S9: 2000 - 1000 - 500 - 250 and 125 µg/plate
WP2 uvrA, with and without S9: 2000 - 1000 - 500 - 250 and 125 µg/plate
As no relevant increase in revertant numbers was observed at any concentration tested, a second main assay using the pre-incubation method (Main Assay II) was conducted with a dose-range slightly modified to take into account the toxicity results of Main Assay I:
TA1535 and TA1537 without S9: 500 - 250 - 125 - 62.5, 31.3 and 15.6 µg/plate
TA1535 and TA1537, with S9: 1000 - 500 - 250 - 125 - 62.5 and 31.3 µg/plate
TA98, with and without S9: 1000 - 500 - 250 - 125 - 62.5 and 31.3 µg/plate
TA100, without S9: 250 - 125 - 62.5, 31.3 - 15.6 and 7.81 µg/plate
TA100 with S9: 1000 - 500 - 250 - 125 - 62.5, 31.3 and 15.6 µg/plate
WP2 uvrA, with and without S9: 1000 - 500 - 250 - 125 - 62.5 and 31.3 µg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle: DMSO is compatible with the survival of the bacteria and the S9 metabolic activity. The test item was found to be soluble at 100 mg/mL. This result permitted a maximum concentration of 5000 µg/plate to be used in the toxicity test.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 without S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA1535 with S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA1537 with S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 without S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA98 with S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 without S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA100 with S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Remarks:
- untreated plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- WP2 uvrA with S9
- Details on test system and experimental conditions:
- PRELIMINARY TOXICITY PLATE:
- A preliminary toxicity test was undertaken in order to select the concentrations to be used in the main assays.
- The "untreated" plates received no treatment while the plates at dose level 0.00 are solvent control plates.
- A wide range of dose levels of the test item, set at half-log intervals, were used: 50 - 158 - 500 - 1580 and 5000 µg/plate.
- Treatments were performed both in the absence and presence of S9 metabolism using the plate incorporation method
- A single plate was used at each test point and positive controls were not included.
- Toxicity was assessed on the basis of a decline in the number of spontaneous revertants, a thinning of the background lawn or a microcolony formation.
MAIN EXPERIMENTS
- The main experiments were conducted on the basis of the preliminary toxicity test.
- Three replicates plates were performed at each test point.
- The "untreated" plates received no treatment while the plates at dose level 0.00 are solvent control plates. Posiitve controls were added for each strain, and both in absence and in presence of metabolic activation.
- Plate incorporation method (first main experiment): The mixture (overlay agar + test or control item + S9 mix or phosphate buffer + bacterial suspension) was directly poured onto the surface of a minimal medium agar plate and allowed to solidify prior to incubation.
- Preincubation method (second main experiment): The mixture (test or control item + S9 mix or phosphate buffer + bacterial suspension) was directly placed for 30 minutes at 37°C. Then overlay agar was added and the mixture was poured onto the surface of a minimal medium agar plate and allowed to solidify
- The prepared plates were inverted and incubated for approximately 72 hours at 37°C. After this period of incubation, plates were held at 4°C for 24 hours or immediately scored by counting the number of revertant colonies on each plate.
- Cytotoxicity: It was indicated by thinning of the background lawn and/or reduction in revertant numbers or microcolony formation. it was assessed all tester strains, both in the absence and presence of S9 metabolism, in the preliminary experiment and in the main experiments.
- Genotoxicity: It was indicated by the increase in the revertants number compared to the negative control. The number of colonies were counted for both the main experiments in each individual plate. The mean and standard error of the mean for each test point, together with a statistical analysis were calculated. - Rationale for test conditions:
- The concentration ranges were defined following a cytotoxicity assay. As no relevant increase in revertant numbers was observed at any concentration tested in the first assay, a pre-incubation step was included for all treatments in a second assay.
- Evaluation criteria:
- - For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels.
- The mean plate counts for untreated and positive control plates must be fall within the Testing Facilities historical control data
Results and discussion
Test resultsopen allclose all
- 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
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- SOLUBILITY:
- Vehicle (DMSO): The test item was found to be soluble in DMSO at 100 mg/mL.
- Precipitation in the test: No precipitation of the test item was observed at the end of the incubation period at any concentration.
RANGE-FINDING STUDIES (PRELIMINARY EXPERIMENT):
The test item was assayed in the toxicity test (preliminary experiment at a maximum dose level of 5000 µg/plate and at four lower concentrations spaced at approximately half-log intervals: 1580, 500, 158 and 50.0 µg/plate.
In the absence of metabolic activation, toxicity (indicated by the decrease of the revertants number and/or the thining of the background lawn) was observed at the three highest dose levels for the the strains TA 1535, TA 1537 and TA 100. For the strains WP2 uvrA and TA 98, toxicity was only noted at the two highest dose levels.
In the presence of metabolic activation, toxicity was observed at the three highest dose levels for the the strain TA 1537 and at the two highest dose levels for the other strains..
MAIN EXPERIMENT:
No relevant increase in the number of revertant colonies was observed in the plate incorporation or pre-incubation assay, at any dose level, with any tester strain, in the absence or presence of S9 metabolism.
Results show that mean plate counts for untreated and positive control plates fell within the Testing Facilities acceptance criteria based on historical control data
The study was therefore accepted as valid.
Any other information on results incl. tables
Preliminary experiment - Without metabolic activation
Dose level (µg/plate) |
TA-1535 (revertants/palte) |
TA-1537 (revertants/plate |
TA-98 (revertants/plate) |
TA-100 (revertants /plate) |
WP2 uvrA (revertants /plate) |
Untreated |
17 |
12 |
24 |
174 |
34 |
Vehicle |
14 |
15 |
26 |
180 |
33 |
50 |
13 |
10 |
30 |
171 |
36 |
158 |
22 |
12 |
28 |
149 |
37 |
500 |
6 * |
11 * |
15 |
124 * |
32 |
1580 |
8 * |
3 * |
19 * |
118 * |
22 * |
5000 |
9 * |
7 * |
20 * |
122 * |
25 * |
*: thinning of the background lawn
Preliminary experiment - With metabolic activation
Dose level (µg/plate) |
TA-1535 (revertants/palte) |
TA-1537 (revertants/plate |
TA-98 (revertants/plate) |
TA-100 (revertants /plate) |
WP2 uvrA (revertants /plate) |
Untreated |
19 |
23 |
28 |
184 |
37 |
Vehicle |
16 |
28 |
31 |
187 |
39 |
50 |
19 |
22 |
27 |
183 |
32 |
158 |
10 |
19 |
35 |
175 |
41 |
500 |
12 |
12 * |
28 |
169 |
31 |
1580 |
13 * |
13 * |
30 * |
139 * |
29 * |
5000 |
19 * |
14 * |
24 * |
121 * |
26 * |
*: thinning of the background
First main experiment - Plate incorporation method - With and Without metabolic activation - Mean result for each point
Dose level
(µg/plate) |
TA 1535 (mean revertants/plate) |
TA 1537 (mean revertants/plate) |
TA 98 (mean revertants/plate) |
TA 100 (mean revertants/plate) |
TA 100 (mean revertants/plate) |
|||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
|
Untreated |
16 |
20 |
21 |
24 |
34 |
41 |
117 |
134 |
31 |
36 |
Vehicle |
15 |
18 |
22 |
26 |
29 |
39 |
129 |
134 |
32 |
37 |
31.3 |
15 |
NT |
20 |
26 |
NT |
NT |
NT |
NT |
NT |
NT |
62.5 |
15 |
20 |
22 |
24 |
36 |
NT |
121 |
NT |
NT |
NT |
125 |
18 |
17 |
21 |
25 |
27 |
42 |
120 |
117 |
29 |
35 |
250 |
17 |
15 |
18 |
24 |
29 |
34 |
104 * |
118 |
28 |
36 |
500 |
17 * |
14 |
16 * |
21 |
27 |
41 |
87 * |
118 |
33 |
37 |
1000 |
NT |
16 * |
10 * |
20 * |
24 * |
34 * |
68 * |
97 * |
25 * |
37 * |
2000 |
NT |
17 * |
NT |
NT |
20 * |
33 * |
NT |
66 * |
17 * |
35 * |
Positive control |
529 |
116 |
220 |
110 |
145 |
532 |
588 |
1142 |
205 |
271 |
*: thinning of the background lawn / NT: not tested
Second main experiment - Preincubation method - With and Without metabolic activation - Mean result for each point
Dose level
(µg/plate) |
TA 1535 (mean revertants/plate) |
TA 1537 (mean revertants/plate) |
TA 98 (mean revertants/plate) |
TA 100 (mean revertants/plate) |
TA 100 (mean revertants/plate) |
|||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
|
Untreated |
18 |
20 |
22 |
24 |
29 |
44 |
154 |
139 |
28 |
34 |
Vehicle |
16 |
19 |
18 |
26 |
28 |
38 |
119 |
123 |
29 |
30 |
7.81 |
NT |
NT |
NT |
NT |
NT |
NT |
112 |
NT |
NT |
NT |
15.6 |
16 |
NT |
20 |
NT |
NT |
NT |
109 |
125 |
NT |
NT |
31.3 |
16 |
17 |
17 |
23 |
27 |
37 |
112 |
115 |
25 |
33 |
62.5 |
16 |
16 |
18 |
22 |
27 |
36 |
111 * |
108 |
32 |
32 |
125 |
16 * |
18 * |
15 * |
23 |
28 |
36 |
97 * |
93 * |
27 |
33 |
250 |
13 * |
15 * |
11 * |
16 * |
25 * |
38 |
101 * |
99 * |
28 * |
32 * |
500 |
M |
15 * |
4 * |
16 * |
32 * |
27 * |
NT |
84 * |
27 * |
31 * |
1000 |
NT |
17 * |
NT |
19 * |
23 * |
30 * |
NT |
88 * |
30 * |
24 * |
Positive control |
516 | 100 | 189 | 99 | 151 | 543 | 609 | 941 | 181 | 237 |
*: thinning of the background lawn / NT: not tested / M: microcolony formation
Applicant's summary and conclusion
- Conclusions:
- The test item did not induce two-fold increases in the number of revertant colonies, at any dose level, in any tester strain, in the absence or presence of S9 metabolism. On the basis of the stated criteria it must be concluded that the test item TRICHLOROETHYLIC ADDUCT is not mutagenic to S. typhimurium or E. coli, under the reported experimental conditions.
- Executive summary:
The test item TRICHLOROETHYLIC ADDUCT was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy. The five tester strains TA1535, TA1537, TA98, TA100 and WP2 uvrA were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone. This study was conducted according to the OECD guideline 471.
The test item was used as a solution in dimethylsulfoxide (DMSO).
The test item was assayed in the toxicity test at a maximum concentration of 5000 µg/plate and at four lower concentrations: 1580, 500, 158 and 50.0 µg/plate. No precipitation of the test item was observed at the end of the incubation period at any concentration. Toxicity was observed with all tester strains at the two or three highest dose levels, both in the absence and presence of S9 metabolism.
On the basis of toxicity test results, a first main assay was conducted using the plate incorporation method over the dose range 31.3 - 2000 µg/plate.
Toxicity was observed with all tester strains at higher dose levels both in the absence and presence of S9 metabolism. No precipitation of the test item was observed at the end of the incubation period at any concentration. No relevant increase in revertant numbers was observed at any concentration tested.
A second main assay was conducted using the preincubation method over the dose range 15.6 - 1000 µg/plate.
Toxicity was observed with all tester strains at higher dose levels, both in the absence and presence of S9 metabolism. No precipitation of the test item was observed at the end of the incubation period at any concentration. No relevant increase in revertant numbers was observed at any concentration tested.
In conclusion, the test item did not induce increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the absence or presence of S9 metabolism.
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