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EC number: 200-913-6 | CAS number: 75-89-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-10-02 to 2003-12-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : only the 2-Anthramine is used as a positive control for the efficacy of S9 mix.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- : only the 2-Anthramine is used as a positive control for the efficacy of S9 mix.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2,2-trifluoroethanol
- EC Number:
- 200-913-6
- EC Name:
- 2,2,2-trifluoroethanol
- Cas Number:
- 75-89-8
- Molecular formula:
- C2H3F3O
- IUPAC Name:
- 2,2,2-trifluoroethan-1-ol
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): 2,2,2 trifluoroethanol (TFE)
- Physical state: colorless liquid
- Lot/batch No.: 02 092 01
- Expiration date of the lot/batch: no data
- Stability under test conditions: assumed to be stable during the test (sponsor responsibility)
- Storage condition of test material: at room temperature
- Other: the pH of the undiluted test item, measured at CIT, was approximately 4.
Constituent 1
Method
- Target gene:
- Each strains derived from S. thyphimurium LT2 contains one mutation in the histidine 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: mutated in rfa gene and presence of an additional plasmid pKM101 in order to enhance the sensitivity of detection of some mutagens. See Table 7.6.1/1
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction was purchased from Moltox (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: 10, 100, 500, 1000, 2500, 5000 µg/plate.
Mutagenicity experiments: 312.5, 625, 1250, 2500 and 5000 µg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water (Batch No. EVE19D (Fresenius Kabi, Sèvres, France)
- Justification for choice of solvent/vehicle: the test item is freely soluble in the water at 50 mg/mL
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 9-Aminoacridine, 2-Nitrofluorene, Mitomycin C for without S9 mix efficacy control. 2-Anthramine for with S9 mix efficacy control. See details in Table 7.6.1/3
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
direct plate incorporation: test item solution (0.1 mL), S9 mix when required or phosphate buffer pH 7.4 (0.5 mL) and bacterial suspension (0.1 mL) were mixed with 2 mL of overlay agar (containing traces of the relevant aminoacid and biotin and maintained at 45°C). After rapid homogenization, the mixture was overlaid onto a Petri plate containing minimum medium.
or preincubation method: test item solution (0.1 mL), S9 mix (0.5 mL) and the bacterial suspension (0.1 mL) were incubated for 60 minutes at 37°C, under shaking, before adding the overlay agar and pouring onto the surface of a minimum agar plate.
DURATION
- Preincubation period: 60 min at 37°C
- Exposure duration: 48 or 72 hours
SELECTION AGENT (mutation assays): not applicable
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: 3 plates/dose/strain. For the mutagenicity experiments, two independent experiments were performed.
NUMBER OF CELLS EVALUATED: no data
DETERMINATION OF CYTOTOXICITY
- Method: observation of the decrease in the number of revertant colonies and/or thinning of the bacterial lawn
OTHER EXAMINATIONS:
- Determination of polyploidy: not required
- Determination of endoreplication: not required
- Other:
OTHER: - Evaluation criteria:
- 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
- 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 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- 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 applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS: not applicable
RANGE-FINDING/SCREENING STUDIES: No observation of cytotoxicity and mutagenicity in the 3 strains tested (TA98, TA100 and TA102) at the concentrations of 10, 100, 500, 1000, 2500, and 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: The number of revertants for the vehicle and positive controls was similar to the historical data.
ADDITIONAL INFORMATION ON CYTOTOXICITY: no additional information
Any other information on results incl. tables
Table 7.6.1/4:Number of revertants per plate in the absence of metabolic activation in the first test (direct plate incorporation method)
TFE 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 |
2 |
6 |
2 |
30 |
5 |
85 |
9 |
468 |
21 |
321.5 |
16 |
5 |
6 |
5 |
36 |
14 |
125 |
50 |
476 |
45 |
625 |
14 |
5 |
7 |
1 |
45 |
34 |
107 |
21 |
452 |
46 |
1250 |
13 |
5 |
5 |
1 |
38 |
10 |
118 |
23 |
491 |
12 |
2500 |
13 |
5 |
9 |
4 |
47 |
24 |
106 |
7 |
539 |
64 |
5000 |
11 |
2 |
6 |
2 |
24 |
7 |
150 |
56 |
495 |
19 |
Positive control** |
517 |
27 |
380 |
67 |
201 |
19 |
544 |
35 |
1909 |
105 |
$: Mean of triplicate
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- NaN3(1 µg/plate) in TA1535 and TA100 strains
- 9AA (50 µg/plate) in TA1537 strain
- 2NF (0.5 µg/plate) in TA 98 strain
- MMC ( 0.5 µg/plate) in TA 102 strain
Table 7.6.1/5:Number of revertants per plate in the presence of metabolic activation (S9 mix) in the first test (direct plate incorporation method)
TFE Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 102 |
|||||
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
Mean$ |
Standard deviation |
|
0* |
17 |
5 |
12 |
2 |
34 |
9 |
113 |
10 |
628 |
30 |
321.5 |
12 |
2 |
9 |
3 |
35 |
7 |
120 |
25 |
651 |
30 |
625 |
17 |
6 |
10 |
2 |
31 |
1 |
133 |
12 |
645 |
55 |
1250 |
13 |
3 |
7 |
1 |
38 |
3 |
111 |
17 |
652 |
17 |
2500 |
18 |
2 |
11 |
5 |
33 |
14 |
123 |
16 |
643 |
33 |
5000 |
16 |
2 |
10 |
7 |
25 |
2 |
104 |
1 |
657 |
48 |
Positive control** |
181 |
16 |
218 |
51 |
731 |
85 |
512 |
85 |
2004 |
331 |
$: Mean of triplicate
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- 2AM (2µg/plate) in TA1535, TA1537, TA98, TA100 strains
- 2AM (10µg/plate) in TA102 strain
Table 7.6.1/6:Number of revertants per plate in the absence of metabolic activation in the second test (direct plate incorporation method)
TFE 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 |
5 |
6 |
2 |
19 |
6 |
95 |
10 |
382 |
33 |
321.5 |
12 |
6 |
6 |
2 |
13 |
6 |
99 |
11 |
421 |
37 |
625 |
15 |
2 |
8 |
3 |
23 |
4 |
88 |
12 |
412 |
32 |
1250 |
10 |
3 |
11 |
5 |
19 |
1 |
109 |
3 |
413 |
28 |
2500 |
12 |
2 |
8 |
2 |
18 |
2 |
107 |
4 |
403 |
31 |
5000 |
10 |
6 |
8 |
2 |
19 |
4 |
113 |
14 |
436 |
5 |
Positive control** |
490 |
30 |
261 |
20 |
158 |
25 |
599 |
15 |
2748 |
54 |
$: Mean of triplicate
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- NaN3(1 µg/plate) in TA1535 and TA100 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 in the presence of metabolic activation (S9 mix) in the second test (pre-incubation method)
TFE 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* |
19 |
5 |
7 |
4 |
28 |
3 |
116 |
4 |
619 |
25 |
321.5 |
15 |
3 |
7 |
4 |
33 |
6 |
131 |
13 |
612 |
1 |
625 |
13 |
2 |
7 |
3 |
22 |
4 |
134 |
10 |
612 |
27 |
1250 |
13 |
1 |
9 |
4 |
27 |
3 |
123 |
6 |
609 |
30 |
2500 |
13 |
1 |
9 |
2 |
26 |
6 |
118 |
9 |
624 |
25 |
5000 |
12 |
4 |
8 |
2 |
28 |
2 |
109 |
10 |
657 |
13 |
Positive control** |
152 |
17 |
56 |
6 |
1384 |
55 |
660 |
28 |
3261 |
178 |
$: Mean of triplicate
*Solvent control = negative control: 100 µL water
**Mutagens positive controls:
- 2AM (2µg/plate) in TA1535, TA1537, TA98, TA100 strains
- 2AM (10µg/plate) in TA102 strain
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test item 2,2,2-trifluoroethanol 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, 2,2,2-trifluoroethanol (99.95%) diluted in water at concentrations of 312.5, 625, 1250, 2500, and 5000 µg/plate was tested in S. typhimurium TA1535, TA1537, TA100, TA98 and TA102 in the presence and the absence of mammalian metabolic activation (S9) using the direct incorporation or the preincubation method.The positive controls induced the appropriate responses in the corresponding strains.
No induced revertants over background was observed in any strains of S. typhimurium up to the highest concentration of 2,2,2-trifluoroethanol.
Under the test conditions, 2,2,2-trifluoroethanol did not show any mutagenic activity in the bacterial reverse mutation test using Salmonella typhimurium. This study is considered as acceptable as it satisfied the criteria of the OECD Guideline No. 471.
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