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EC number: 206-851-6 | CAS number: 383-63-1
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 26 april 2007 to 30 May 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to the OECD (No. 471) and EC (B13/14) guidelines and is in compliance with the GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interministériel des produits chimiques, 8th March 2007
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Ethyl trifluoroacetate
- EC Number:
- 206-851-6
- EC Name:
- Ethyl trifluoroacetate
- Cas Number:
- 383-63-1
- Molecular formula:
- C4H5F3O2
- IUPAC Name:
- ethyl 2,2,2-trifluoroacetate
- Details on test material:
- - Name of test material (as cited in study report): study plan: Trifluoroacétate d'éthyle; Labeling: Ethyl Trifluoroacetate; Analytical certificate: Ethyl Trifluoroaxetate. All names corresponded to the same test item.
- Physical state: clear colorless liquid
- Stability under test conditions: no data, assume to be stable (sponsor responsibility)
- Storage condition of test material: at room temperature and protected from light and humidity
Constituent 1
Method
- Target gene:
- Each strains derived from S. thyphimurium LT2 contains one mutation in the histine operon, resulting in a requirement for histidine.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: additional mutations in rfa and uvrB genes. For the strains TA98 and TA100 presence of an additional plasmid pKM101 in order to enhance their sensitivity of detection of some mutagens. See Table 7.6.1/1
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: additional mutation in rfa gene and presence of an additional plasmid pKM101 in order to enhance their sensitivity of detection of some mutagens. The histidine mutation is located on the multicopy plasmid pAQ1. See Table 7.6.1/1
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Moltox (Molecular Toxicology, INC, Boone, NC 28607, USA) and obtained from the liver of rats treated with Aroclor 1254 (500 mg/kg) by the intraperitoneal route.
- Test concentrations with justification for top dose:
- Preliminary test: from 10 to 5000 µg/plate
Main test (2 independent tests): from 312.5 to 5000 µg/plate
See details in Table 7.6.1/2. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (Dimethylsulfoxide), batch No. K35781950609, VWR (Fontenay-Sous-Bois, France)
- Justification for choice of solvent/vehicle: the test item is freely soluble in in this vehicle at a concentration of 100 mg/mL.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: TA 1535 and TA 100 (see details in Table 7.6.1/3)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: TA 1537 (see details in Table 7.6.1/3)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: TA 98 (see details in Table 7.6.1/3)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in distilled water
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: TA 102 (see details in Table 7.6.1/3)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive control substance:
- other: 2 Anthramine for TA 1535, TA 1537, TA 98 and TA 102 (see details in Table 7.6.1/3)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: TA 100 (see details in Table 7.6.1/3)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) (for both experiment without S9 mix and for the first experiment with S9 mix); preincubation (for the second experiment with S9 mix).
DURATION
- Preincubation period: 60 minutes at 37°C
- Exposure duration: 48 or 72h
- Expression time (cells in growth medium): revertants are scored immediately after the end of exposure.
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not applicable
SELECTION AGENT (mutation assays): not applicable
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS:on eplate for the preliminary test, 3 replicate for both independent main tests
NUMBER OF CELLS EVALUATED: the number of all revertants per plate was scored
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertant colonies and/or thining of the bacterial lawn
OTHER EXAMINATIONS:
- Determination of polyploidy: not applicable
- Determination of endoreplication: not applicable - Evaluation criteria:
- This study is considered valid if the number of revertants in the vehicle controls is consistent with the historical data of the testing facility and if the number of revertants in the positive controls is higher than that of the vehicle controls and is consistent with the historical data of the testing facility.
A reproducible 2-fold increase (for the TA 98, Ta 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained. - Statistics:
- No data.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- A slight increase in the number of revertants was noted at 5000 µg/plate in the TA 100 strain in the second experiment without S9 mix. Since this slight increase was neither dose-related nor reproducible, it was not considered as biologically relevant.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- see details in Tables 7.6.1/4, 7.6.1/5, 7.6.1/6, 7.6.1/7
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- see details in Tables 7.6.1/4, 7.6.1/5, 7.6.1/6, 7.6.1/7
- 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 applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not tested
- Effects of osmolality: not tested
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: no precipitate was observed in the Petri plates
RANGE-FINDING/SCREENING STUDIES: Since the test item was freely soluble and non-toxic in the preliminary test, the highest selected dose-level was 5000 µg/plate, according to the criteria specified in the international guidelines.
COMPARISON WITH HISTORICAL CONTROL DATA: the number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered as valid.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No noteworthy toxicity was observed in any of the five strains, in either experiment, with ot without 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 7.6.1/4:Number of revertants per plate (mean of triplicates) in the absence of metabolic activation in the first test (direct plate incorporation method)
TFAE Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 102 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
24 |
4 |
10 |
2 |
27 |
19 |
139 |
11 |
391 |
56 |
321.5 |
25 |
3 |
6 |
1 |
24 |
1 |
135 |
21 |
346 |
14 |
625 |
25 |
9 |
10 |
3 |
22 |
5 |
130 |
14 |
393 |
11 |
1250 |
21 |
2 |
8 |
5 |
29 |
5 |
140 |
9 |
445 |
70 |
2500 |
21 |
4 |
6 |
1 |
25 |
8 |
157 |
42 |
361 |
7 |
5000 |
16 |
6 |
6 |
2 |
23 |
5 |
156 |
52 |
371 |
33 |
Positive control** |
535 |
47 |
554 |
187 |
268 |
40 |
638 |
58 |
2878 |
138 |
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- NaN3(1 µg/plate) in TA 1535 and TA 100 strains
- 9AA (50 µg/plate) in TA 1537 strain
- 2NF (0.5 µg/plate) in TA 98 strain
- MMC ( 0.5 µg/plate) in TA 102 strain
Table 7.6.1/5:Number of revertants per plate (mean of triplicates) in the presence of metabolic activation (S9 mix) in the first test (direct plate incorporation method)
TFAE Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 102 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
13 |
3 |
8 |
3 |
26 |
3 |
118 |
8 |
359 |
23 |
321.5 |
21 |
8 |
14 |
3 |
32 |
5 |
123 |
32 |
562 |
61 |
625 |
10 |
5 |
15 |
4 |
35 |
8 |
114 |
14 |
438 |
34 |
1250 |
19 |
6 |
13 |
3 |
39 |
8 |
131 |
10 |
512 |
90 |
2500 |
15 |
1 |
11 |
2 |
29 |
3 |
123 |
10 |
389 |
16 |
5000 |
8 |
2 |
7 |
3 |
44 |
17 |
113 |
16 |
367 |
36 |
Positive control** |
195 |
10 |
145 |
22 |
1465 |
140 |
722 |
237 |
3911 |
899 |
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- 2AM (2µg/plate) in TA1535, TA 1537, TA 98 strains
- 2AM (10µg/plate) in TA 102 strain
- BAP (5µg/plate) in TA 100 strain
Table 7.6.1/6:Number of revertants per plate (mean of triplicates) in the absence of metabolic activation in the second test (direct plate incorporation method)
TFAE Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 102 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
11 |
3 |
9 |
4 |
26 |
7 |
116 |
21 |
447 |
54 |
321.5 |
20 |
8 |
9 |
3 |
28 |
8 |
115 |
5 |
378 |
38 |
625 |
18 |
5 |
6 |
2 |
25 |
7 |
156 |
61 |
447 |
34 |
1250 |
21 |
5 |
6 |
3 |
33 |
5 |
120 |
6 |
471 |
33 |
2500 |
23 |
5 |
2 |
2 |
27 |
6 |
120 |
19 |
503 |
66 |
5000 |
18 |
3 |
3 |
1 |
38 |
22 |
235 |
95 |
480 |
36 |
Positive control** |
602 |
15 |
362 |
0 |
181 |
15 |
729 |
16 |
2274 |
50 |
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- NaN3(1 µg/plate) in TA 1535 and TA 100 strains
- 9AA (50 µg/plate) in TA1537 strain
- 2NF (0.5 µg/plate) in TA 98 strain
- MMC ( 0.5 µg/plate) in TA 102 strain
Table 7.6.1/7:Number of revertants per plate (mean of triplicates) in the presence of metabolic activation (S9 mix) in the second test (pre-incubation method)
TFAE Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 102 |
|||||
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
Mean |
Standard deviation |
|
0* |
15 |
9 |
17 |
5 |
37 |
6 |
124 |
10 |
443 |
42 |
321.5 |
10 |
3 |
11 |
1 |
36 |
9 |
144 |
20 |
530 |
87 |
625 |
17 |
7 |
5 |
3 |
35 |
1 |
126 |
14 |
505 |
174 |
1250 |
16 |
7 |
10 |
4 |
45 |
19 |
134 |
6 |
520 |
109 |
2500 |
14 |
2 |
14 |
2 |
38 |
7 |
108 |
9 |
553 |
16 |
5000 |
16 |
2 |
13 |
1 |
42 |
7 |
119 |
8 |
682 |
174 |
Positive control** |
146 |
13 |
130 |
18 |
1255 |
133 |
756 |
76 |
2213 |
169 |
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- 2AM (2µg/plate) in TA 1535, TA 1537, TA 98 strains
- 2AM (10µg/plate) in TA 102 strain
- BAP (5µg/plate) in TA 100 strain
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under the test conditions, the test item Ethyl trifluoroacetate did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium. - Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD No.471 and EC No.B13/14 guidelines, and in compliance with the GLP, strains TA1535, TA1537, TA100, TA98 and TA102 of S. typhimurium were exposed to ethyl trifluoroacetate (99.94%) diluted in DMSO in the presence and absence of mammalian metabolic activation (fraction of S9 from the liver of rats treated with Aroclor 1254). In the preliminary test, 6 concentrations of test substance were tested (10, 100, 500, 1000, 2500 and 5000 µg/plate). Since the test item was freely soluble and non-toxic in the preliminary test, the highest selected dose-level for the two independent main tests was 5000 µg/plate, according to the criteria specified in the international guidelines. Three replicates were realized per concentration of Ethyl trifluoroacetate in the main test. Furthermore, method of direct incorporation and protocol with a preincubation step were tested.
The positive controls induced the appropriate responses in the corresponding strains. Ethyl Trifluoroacetate was tested therefore up to limit concentration (5000 µg/plate) and no cytotoxicity was observed. No significant increase of the number of revertants was observed in any bacterial strains tested with Ethyl trifluoroacetate (at any concentrations).
Under the test conditions, Ethyl Trifluoroacetate did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium as there was no evidence of induced mutant colonies over background.
This study is considered as acceptable and satisfies the requirement for mutagenicity endpoint.
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