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EC number: 202-635-0 | CAS number: 98-08-8
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- 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
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- Genetic toxicity
- Carcinogenicity
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- 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:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- α,α,α-trifluorotoluene
- EC Number:
- 202-635-0
- EC Name:
- α,α,α-trifluorotoluene
- Cas Number:
- 98-08-8
- Molecular formula:
- C7H5F3
- IUPAC Name:
- α,α,α-trifluorotoluene
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- SD Rat (7 week old, male) liver induced by phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- [1st trial]
-S9 mix: 0, 31.3, 62.5, 125, 250, 500 and 1000 μg/plate (TA1535, TA100 and TA1537)
0, 62.5, 125, 250, 500, 1000 and 2000 μg/plate (TA98 and WP2 uvrA)
+S9 mix: 0, 31.3, 62.5, 125, 250, 500 and 1000 μg/plate (TA1535 and TA1537)
0, 62.5, 125, 250, 500 and 1000 μg/plate (TA100, TA98 and WP2 uvrA)
[2nd trial]
-S9 mix: 0, 31.3, 62.5, 125, 250, 500 and 1000 μg/plate (all strains)
+S9 mix: 0, 31.3, 62.5, 125, 250, 500 and 1000 μg/plate (TA1535 and TA1537)
0, 62.5, 125, 250, 500 and 1000 μg/plate (TA100, TA98 and WP2 uvrA) - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: The test substance is highly soluble in DMSO.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: -S9 mix: AF-2 (TA100, TA98 and WP2 uvrA), +S9 mix: 2-Aminoanthracene (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hrs
NUMBER OF PLATES: 3
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: other: growth inhibition - Evaluation criteria:
- In any strain(s) tested under conditions with or without S9 mix, when the mean number of revertant colonies per plate increased twice more than that of the vehicle control and when the increase was shown to be dose-related and reproducible, the chemical was judged to be mutagenic.
Results and discussion
Test resultsopen allclose all
- 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:
- not examined
- Positive controls validity:
- valid
- 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:
- not examined
- Positive controls validity:
- valid
- 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:
- not examined
- Positive controls validity:
- valid
- 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:
- not examined
- Positive controls validity:
- valid
- 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:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
- Concentration range: 50 - 5000 μg/plate (common ratio: 3)
- Cytotoxic conc.: -S9 mix & +S9 mix: >=1500 µg/plate (TA100, TA98, WP2 uvrA);
>=500 μg/plate (TA1535,TA1537)
ADDITIONAL INFORMATION ON CYTOTOXICITY:
[1st trial]
-S9 mix: 2000 μg/plate (WP2 uvrA); 1000 μg/plate (TA100, TA98, TA1537); 500 μg/plate (TA1535)
+S9 mix: 2000 μg/plate (WP2 uvrA, TA100, TA98); 1000 μg/plate (TA1537); 500 μg/plate (TA1535)
[2nd trial]
-S9 mix: 1000 μg/plate (WP2 uvrA, TA98); 500 μg/plate (TA100, TA1535, TA1537)
+S9 mix: 2000 μg/plate (WP2 uvrA, TA100); 1000 μg/plate (TA1535, TA98); 500 μg/plate (TA1537)
Any other information on results incl. tables
The test item did not induce mutation in the S. typhimurium and E. coli strains with and without S9 mix.
[1st trial]
-S9 mix: Negative (all test strains)
+S9 mix: Negative (all test strains)
Table 1. Mutagenicity of the test item** in reverse mutation test (I) on bacteria
With (+) or without (-) S9 mix |
Test substance dose (μg/plate) |
Number of revertants (Number of colonies/plate, Mean ± SD) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
S9 mix(-) |
0 |
97, 114, 127 (113 ± 15.0) |
10, 8, 13 (10 ± 2.5) |
18, 22, 20 (20 ± 2.0) |
26, 21, 18 (22 ± 4.0) |
11, 8, 5 (8 ± 3.0) |
31.3 |
106, 93, 122 (107 ± 14.5) |
11, 11, 15 (12 ± 2.3) |
ND |
ND |
10, 8, 6 (8 ± 2.0) |
|
62.5 |
111, 121, 118 (117 ± 5.1) |
13, 14, 8 (12 ± 3.2) |
15, 25, 17 (19 ± 5.3) |
23, 25, 26 (25 ± 1.5) |
7, 9, 9 (8 ± 1.2) |
|
125 |
102, 141, 123 (122 ± 19.5) |
10, 11, 6 (9 ± 2.6) |
13, 20, 24 (19 ± 5.6) |
30, 13, 26 (23 ± 8.9) |
9, 7, 9 (8 ± 1.2) |
|
250 |
111, 103, 102 (105 ± 4.9) |
6, 9, 8 (8 ± 1.5) |
18, 17, 21 (19 ± 2.1) |
17, 22, 15 (18 ± 3.6) |
8, 5, 10 (8 ± 2.5) |
|
500 |
91, 93, 99 (94 ± 4.2) |
7*, 11*, 6* (8 ± 2.6) |
20, 16, 26 (21 ± 5.0) |
14, 13, 18 (15 ± 2.6) |
4, 7, 6 (6 ± 1.5) |
|
1000 |
97*, 100*, 100* (99 ± 1.7) |
10*, 11*, 11* (11 ± 0.6) |
16, 25, 18 (20 ± 4.7) |
15*, 21*, 22* (19 ± 3.8) |
6*, 4*, 4* (5 ± 1.2) |
|
2000 |
12*, 24*, 16* (17 ± 6.1) |
25*, 17*, 14* (19 ± 5.7) |
||||
S9 mix(+) |
0 |
122, 108, 105 (112 ± 9.1) |
10, 13, 18 (14 ± 4.0) |
23, 22, 20 (22 ± 1.5) |
43, 35, 33 (37 ± 5.3) |
9, 7, 17 (11 ± 5.3) |
31.3 |
ND |
14, 16, 8 (13 ± 4.2) |
ND |
ND |
13, 8, 13 (11 ± 2.9) |
|
62.5 |
89, 123, 102 (105 ± 17.2) |
8, 10, 7 (8 ± 1.5) |
30, 24, 24 (26 ± 3.5) |
29, 31, 39 (33 ± 5.3) |
15, 11, 8 (11 ± 3.5) |
|
125 |
91, 83, 105 (93 ± 11.1) |
14, 15, 18 (16 ± 2.1) |
22, 40, 39 (34 ± 10.1) |
19, 30, 27 (25 ± 5.7) |
14, 13, 11 (13 ± 1.5) |
|
250 |
77, 98, 103 (93 ± 13.8) |
10, 9, 6 (8 ± 2.1) |
24, 28, 23 (25 ± 2.6) |
31, 27, 30 (29 ± 2.1) |
14, 9, 8 (10 ± 3.2) |
|
500 |
89, 91, 91 (90 ± 1.2) |
8*, 7*, 15* (10 ± 4.4) |
25, 23, 17 (22 ± 4.2) |
33, 36, 23 (31 ± 6.8) |
18, 11, 15 (15 ± 3.5) |
|
1000 |
86, 74, 95 (85 ± 10.5) |
7*, 15*, 11* (11 ± 4.0) |
33, 18, 23 (25 ± 7.6) |
21, 21, 41 (28 ± 11.5) |
18*, 14*, 15* (16 ± 2.1) |
|
2000 |
65*, 72*, 84* (74 ± 9.6) |
16*, 32*, 31* (26 ± 9.0) |
26*, 27*, 27* (27 ± 0.6) |
|||
Positive control S9 mix (-) |
Chemical |
AF2 |
SA |
AF2 |
AF2 |
9AA |
Dose (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
|
Number of |
618, 627, 632 (626 ± 7.1) |
268, 257, 282 (269 ± 12.5) |
146, 138, 104 (129 ± 22.3) |
727, 733, 772 (744 ± 24.4) |
628, 786, 686 (700 ± 79.9) |
|
Positive control S9 mix (+) |
Chemical |
2AA |
2AA |
2AA |
2AA |
2AA |
Dose (μg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|
Number of |
970, 981, 1008 (986 ± 19.6) |
243, 223, 213 (226 ± 15.3) |
1423, 1378, 1280 (1360 ± 73.1) |
259, 263, 258 (260 ± 2.6) |
184, 179, 194 (186 ± 7.6) |
AF2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, SA: Sodium azide, 9AA: 9-Aminoacridine, 2AA: 2-Aminoanthracene
*: Inhibition was observed against growth of the bacteria.
**: Purity was above 98.0 % and water was contained below 0.2 % as impurity.
ND: Not done
[2nd trial]
-S9 mix: Negative (all test strains)
+S9 mix: Negative (all test strains)
Table 2. Mutagenicity of the test item** in reverse mutation test (II) on bacteria
With (+) or without (-) S9 mix |
Test substance dose (μg/plate) |
Number of revertants (Number of colonies/plate, Mean ± SD) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
S9 mix(-) |
0 |
88, 114, 113 (105 ± 14.7) |
18, 15, 16 (16 ± 1.5) |
20, 15, 19 (18 ± 2.6) |
22, 22, 14 (19 ± 4.6) |
11, 14, 9 (11 ± 2.5) |
31.3 |
103, 110, 105 (106 ± 3.6) |
14, 11, 14 (13 ± 1.7) |
17, 17, 19 (18 ± 1.2) |
30, 22, 20 (24 ± 5.3) |
7, 4, 10 (7 ± 3.0) |
|
62.5 |
95, 100, 100 (98 ± 2.9) |
17, 14, 8 (13 ± 4.6) |
20, 21, 34 (25 ± 7.8) |
20, 17, 18 (18 ± 1.5) |
5, 11, 10 (9 ± 3.2) |
|
125 |
93, 93, 108 (98 ± 8.7) |
14, 13, 13 (13 ± 0.6) |
22, 32, 18 (24 ± 7.2) |
21, 14, 20 (18 ± 3.8) |
9, 14, 8 (10 ± 3.2) |
|
250 |
106, 82, 114 (101 ± 16.7) |
13, 7, 14 (11 ± 3.8) |
21, 19, 22 (21 ± 1.5) |
17, 22, 21 (20 ± 2.6) |
10, 7, 11 (9 ± 2.1) |
|
500 |
80*, 68*, 78* (75 ± 6.4) |
15*, 5*, 5* (8 ± 5.8) |
22, 14, 16 (17 ± 4.2) |
16, 23, 29 (23 ± 6.5) |
8*, 10*, 7* (8 ± 1.5) |
|
1000 |
3*, 78*, 79* (53 ± 43.6) |
4*, 2*, 4* (3 ± 1.2) |
25*, 28*, 19* (24 ± 4.6) |
18*, 16*, 19* (18 ± 1.5) |
7*, 7*, 9* (8 ± 1.2) |
|
2000 |
||||||
S9 mix(+) |
0 |
112, 121, 120 (118 ± 4.9) |
8, 12, 12 (11 ± 2.3) |
33, 28, 32 (31 ± 2.6) |
44, 36, 29 (36 ± 7.5) |
19, 10, 19 (16 ± 5.2) |
31.3 |
ND |
13, 13, 18 (15 ± 2.9) |
ND |
ND |
10, 17, 12 (13 ± 3.6) |
|
62.5 |
138, 129, 124 (130 ± 7.1) |
17, 14, 6 (12 ± 5.7) |
35, 33, 29 (32 ± 3.1) |
45, 32, 42 (40 ± 6.8) |
17, 26, 16 (20 ± 5.5) |
|
125 |
133, 103, 118 (118 ± 15.0) |
17, 18, 17 (17 ± 0.6) |
28, 26, 31 (28 ± 2.5) |
27, 38, 44 (36 ± 8.6) |
14, 22, 20 (19 ± 4.2) |
|
250 |
124, 95, 104 (108 ± 14.8) |
9, 14, 13 (12 ± 2.6) |
23, 29, 21 (24 ± 4.2) |
43, 38, 25 (35 ± 9.3) |
11, 10, 13 (11 ± 1.5) |
|
500 |
81, 96, 107 (95 ± 13.1) |
12, 12, 11 (12 ± 0.6) |
24, 23, 26 (24 ± 1.5) |
36, 24, 33 (31 ± 6.2) |
13*, 11*, 9* (11 ± 2.0) |
|
1000 |
75, 96, 104 (92 ± 15.0) |
13*, 6*, 6* (8 ± 4.0) |
24, 23, 19 (22 ± 2.6) |
25*, 27*, 23* (25 ± 2.0) |
7*, 10*, 11* (9 ± 2.1) |
|
2000 |
59*, 72*, 84* (72 ± 12.5) |
18*, 20*, 22* (20 ± 2.0) |
20*, 23*, 22* (22 ± 1.5) |
|||
Positive control S9 mix (-) |
Chemical |
AF2 |
SA |
AF2 |
AF2 |
9AA |
Dose (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
|
Number of colonies/plate |
506, 526, 513 (515 ± 10.1) |
207, 224, 235 (222 ± 14.1) |
100, 116, 124 (113 ± 12.2) |
756, 631, 787 (725 ± 82.6) |
890, 726, 734 (783 ± 92.5) |
|
Positive control S9 mix (+) |
Chemical |
2AA |
2AA |
2AA |
2AA |
2AA |
Dose (μg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|
Number of colonies/plate |
1164, 1206, 1145 (1172 ± 31.2) |
254, 288, 268 (270 ± 17.1) |
913, 869, 854 (879 ± 30.7) |
372, 303, 455 (377 ± 76.1) |
163, 180, 169 (171 ± 8.6) |
AF2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, SA: Sodium azide, 9AA: 9-Aminoacridine, 2AA: 2-Aminoanthracene
*: Inhibition was observed against growth of the bacteria.
**: Purity was above 98.0 % and water was contained below 0.2 % as impurity.
ND: Not done
Applicant's summary and conclusion
- Conclusions:
- The test item was not mutagenic to Salmonella typhimurium TA100, TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA, with or without an exogenous metabolic activation system.
- Executive summary:
The test item was examined for its mutagenic activity in two series of a bacterial reverse mutation assay (OECD 471) employing Salmonella typhimurium TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA as indicator organisms.
The plate incorporation test with and without addition of liver S9 mix from SD Rat (7 week old, male) liver, induced by phenobarbital and 5,6-benzoflavone, was used. In this study, two experimental series were performed. Treatments of all tester strains were performed using the test item solved in DMSO in the absence and in the presence of S9 mix, using final concentrations between 31.3 and 2000 µg/plate, plus vehicle and positive controls.
The strain specific positive control test materials, namely AF-2, sodium azide and 9-aminoacridine in the absence of S9 mix, yielded the expected mutant frequencies. The genotype of the tester strains used was thus confirmed. 2-Aminoanthracene which requires metabolic activation, was strongly mutagenic. This indicates that the exogenous metabolizing system used in the present investigation (S9 mix) was functioning. Thus, the study was considered valid.
No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix. During the experiments there was no evidence of toxicity to the bacteria caused by the test material exposure.
Under the conditions described, there were no relevant increases in revertant numbers after treatment with the test item observed in both, the absence and presence of S9 mix.
In conclusion, the test material was considered to be non-mutagenic under the described experimental conditions.
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