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EC number: 213-059-4 | CAS number: 920-66-1
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:
- 22-29 Jun 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted 21 Jul 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1,1,3,3,3-hexafluoropropan-2-ol
- EC Number:
- 213-059-4
- EC Name:
- 1,1,1,3,3,3-hexafluoropropan-2-ol
- Cas Number:
- 920-66-1
- Molecular formula:
- C3H2F6O
- IUPAC Name:
- 1,1,1,3,3,3-hexafluoropropan-2-ol
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- "his operon" (for S. typhimurium strains)
"trp operon" (for E.coli strains)
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats treated with phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- First experiment: 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate with and without metabolic activation
Second experiment: 313, 625, 1250, 2500 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: solubility in distilled water ≥50.0 mg/mL
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2) and 2-Aminoanthracene (2AA) and ICR-191
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicate plates in each of two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: bacterial growth inhibition using a stereomicroscope, and number of revertant colonies counted with a colony counter - Evaluation criteria:
- The test material was judged to be positive for mutagenicity when the number of revertant colonies increased to ≥2X that in the negative control, and when responses were dose-related and/or reproducible. All other cases were judged to be negative.
- Statistics:
- Mean values and standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- HISTORICAL CONTROL DATA (with ranges, means and standard deviation)
- Positive historical control data:
- Negative (solvent/vehicle) historical control data:
Test Period: From December, 2016 to May, 2017
Negative Control (Mean ± 3 SD)
Bacterial Strain TA 100 TA 1535 WP2uvrA TA 98 TA 1537
Strain S9-mix -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9
Mean 124 124 11 11 31 29 21 30 12 14
SD 27 23 4 4 10 9 6 8 5 5
Min 43 55 1 1 1 2 3 6 1 1
Max 205 193 23 23 61 56 39 54 27 29
Positive Control (Mean ± 3 SD)
Bacterial Strain TA 100 TA 1535 WP2uvrA TA 98 TA 1537
Strain S9-mix -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9
Positive Control -- AF-2 2AA NaN3 2AA AF-2 2AA AF-2 2AA ICR-191 2AA
Mean 991 1536 295 302 133 480 486 420 567 194
SD 135 244 63 40 21 145 59 56 102 41
Min 586 804 106 182 70 45 309 252 261 71
Max 1396 2268 484 422 196 915 663 588 873 317
AF-2 = 2-(2-Furyl)-3-(5-nitro-furyl)acrylamide
NaN3 = Sodium Azide
2AA = 2-Aminoanthracene
Any other information on results incl. tables
EXPERIMENT 1 (Standard Plate Test with Incubation) |
|||||
S9-Mix |
Without |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
|
VC |
134.0±6.0 |
8.0±1.0 |
32.0±8.0 |
15.0±4.0 |
10.0±3.0 |
4.88 |
151.0±5.0 |
10.0±3.0 |
33.0±5.0 |
18.0±4.0 |
13.0±1.0 |
19.5 |
141.0±6.0 |
8.0±4.0 |
26.0±8.0 |
16.0±5.0 |
8.0±5.0 |
78.1 |
141.0±12.0 |
9.0±2.0 |
32.0±4.0 |
18.0±5.0 |
10.0±9.0 |
313 |
125.0±21.0 |
7.0±1.0 |
29.0±5.0 |
16.0±4.0 |
12.0±8.0 |
1250 |
142.0±6.0 |
13.0±3.0 |
29.0±6.0 |
16.07±3.0 |
8.0±5.0 |
5000 |
115.0±28.0 |
9.0±5.0 |
30.0±4.0 |
14.0±3.0 |
4.0±3.0 |
PC (mg/plate) |
AF-2 (0.01) |
NaN3(0.5) |
AF-2 (0.01) |
AF-2 (0.1) |
ICR-191 (0.5) |
837.0±128.0 |
273.0±9.0 |
125.0±15.0 |
421.0±15.0 |
461.0±48.0 |
|
S9-Mix |
With |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
|
VC |
144.0±30.0 |
10.0±2.0 |
29.0±10.0 |
34.0±5.0 |
13.0±10.0 |
4.88 |
134.0±11.0 |
11.0±4.0 |
27.0±2.0 |
30.0±8.0 |
12.0±2.0 |
19.5 |
121.0±4.0 |
10.0±3.0 |
25.0±3.0 |
31.0±6.0 |
11.0±2.0 |
78.1 |
138.0±18.0 |
8.0±4.0 |
24.0±6.0 |
31.0±5.0 |
9.0±4.0 |
313 |
133.0±22.0 |
12.0±4.0 |
30.0±5.0 |
28.0±5.0 |
16.0±9.0 |
1250 |
132.0±23.0 |
11.0±3.0 |
23.0±3.0 |
24.0±3.0 |
11.0±1.0 |
5000 |
130.0±45.0 |
8.0±3.0 |
35.0±3.0 |
29.0±3.0 |
12.0±4.0 |
PC (mg/plate) |
2AA (1) |
2AA (2) |
2AA (10) |
2AA (0.5) |
2AA (2) |
932.0±144.0 |
234.0±21.0 |
433.0±69.0 |
384.0±53.0 |
172.0±4.0 |
|
VC = Vehicle control; PC = Positive control
NaN3= Sodium azide
AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
2AA = 2-Aminoanthracene
EXPERIMENT 2 (Standard Plate Test with Incubation) |
|||||
S9-Mix |
Without |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
|
VC |
119.0±11.0 |
9.0±4.0 |
22.0±3.01 |
20.0±8.0 |
10.0±3.0 |
313 |
112.0±14.0 |
10.0±6.0 |
22.0±4.0 |
20.0±5.0 |
9.0±2.0 |
625 |
106.0±1.0 |
9.0±2.0 |
22.0±3.0 |
22.0±2.0 |
11.0±2.0 |
1250 |
110.0±17.0 |
10.0±8.0 |
23.0±7.0 |
18.0±6.0 |
7.0±3.0 |
2500 |
105.0±8.0 |
8.0±4.0 |
26.0±5.0 |
15.0±3.0 |
11.0±4.0 |
5000 |
108.0±12.0 |
5.0±3.0 |
22.0±9.0 |
18.0±4.0 |
8.0±3.0 |
PC (mg/plate) |
AF-2 (0.01) |
NaN3(0.5) |
AF-2 (0.01) |
AF-2 (0.1) |
ICR-191 (0.5) |
853.0±56.0 |
184.0±18.0 |
139.0±6.0 |
408.0±21.0 |
420.0±38.0 |
|
S9-Mix |
With |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
|
VC |
99.0±7.0 |
10.0±4.0 |
19.0±6.0 |
33.0±7.0 |
14.0±5.0 |
313 |
114.0±21.0 |
10.0±4.0 |
21.0±2.0 |
30.0±8.0 |
15.0±5.0 |
625 |
100.0±9.0 |
10.0±2.0 |
25.0±10.0 |
29.0±8.0 |
10.0±5.0 |
1250 |
112.0±5.0 |
9.0±4.0 |
26.0±6.0 |
32.0±7.0 |
12.0±7.0 |
2500 |
120.0±9.0 |
12.0±1.0 |
24.0±3.0 |
36.0±10.0 |
11.0±4.0 |
5000 |
107.0±3.0 |
11.0±4.0 |
23.0±3.0 |
39.0±6.0 |
12.0±4.0 |
PC (mg/plate) |
2AA (1) |
2AA (2) |
2AA (10) |
2AA (0.5) |
2AA (2) |
915.0±57.0 |
186.0±3.0 |
205.0±29.0 |
362.0±32.0 |
133.0±11.0 |
|
VC = Vehicle control; PC = Positive control
NaN3= Sodium azide
AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
2AA = 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: the test material HFIP is negative for mutagenicity (non-mutagenic) with and without metabolic activation.
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