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EC number: 638-734-4 | CAS number: 157248-24-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 2010-11-17 to 2010-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-ethoxy-2,3-difluoro-4'-propyl-1,1'-biphenyl
- EC Number:
- 638-734-4
- Cas Number:
- 157248-24-3
- Molecular formula:
- C₁₇H₁₈F₂O
- IUPAC Name:
- 4-ethoxy-2,3-difluoro-4'-propyl-1,1'-biphenyl
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537: mutations in the histidine operon
Escherichia coli WP2 uvrA: defect in one of the genes for tryptophan biosynthesis
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: his G 46, uvrB, rfa
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- other: his C 3076, uvrB, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: his D 3052, uvrB, rfa + R-factor
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: his G 46, uvrB, rfa + R-factor
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: his G 428, rfa + R-factor
- Species / strain / cell type:
- E. coli WP2 uvr A
- Cytokinesis block (if used):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: S9 fraction derived from rat liver homogenate; from male Wistar rats, HSdCpb:Wu (Harlan Winkelmann, Borchen, Germany), age 6-8 weeks, pretreated with Aroclor (500 mg/kg bw)
- method of preparation of S9 mix: Please refer to “Any other information on materials”.
- concentration or volume of S9 mix and S9 in the final culture medium: 10 % and 30 % S9 in the S9 mix were used in the first and second test series, respectively.
- quality controls of S9: Each S9 batch was tested for its metabolic activity using specific substrates, requiring different enzymes of the P450-isoenzyme family. The mutagenicity of 2-aminoanthracene, benzo[a]pyrene, and 3-methylcholanthrene is thus determined once for each S9 batch. - Test concentrations with justification for top dose:
- 1st series: 5, 15.8, 50, 158, 500, 1580, 5000 µg/plate
2nd series: 50, 88.9, 158, 281 and 500 µg/plate
5000 µg/plate was chosen as the appropriate maximum test material concentration. The test material concentrations used were selected according to the EEC, OECD and Japanese guidelines for this test system. - Vehicle / solvent:
- - Solvent used: acetone
- Justification for choice of solvent: Test item was sufficiently soluble in the solvent. Analysis of the historical data of the laboratory and experience of other research groups showed that the amounts of the selected solvent used has no influence on the number of spontaneous revertants of any strain.
- Justification for percentage of solvent in the final culture medium: not specified
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- cumene hydroperoxide
- other: daunomycin (DAUN)
- Remarks:
- without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- with S9
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 2-3 days
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition
METHODS FOR MEASUREMENTS OF GENOTOXICIY
- Increase of revertant colonies - Rationale for test conditions:
- Test conditions in line with respective test guidelines were used.
- Evaluation criteria:
- The criteria for assessment of colony numbers, based upon the historical controls of the laboratory and statistical considerations, were established (please refer to “Any other information on materials and methods”. All further results, ranging between "no" and "clear", are assessed as "weak increases”.
A test material is defined as non-mutagenic in this assay if
- "no" or "weak increases" occur in the first and second series of the main experiment. ("Weak increases" randomly occur due to experimental variation.)
A test material is defined as mutagenic in this assay if
- a dose-related (over at least two test material concentrations) increase in the number of revertants is induced, the maximal effect is a "clear increase", and the effects are reproduced at similar concentration levels in the same test system;
- "clear increases" occur at least at one test material concentration, higher concentrations show strong precipitation or cytotoxicity, and the effects are reproduced at the same concentration level in the same test system.
In all further cases, a third test series with the bacterial strain in question should be performed and the results of each series be discussed case by case. - Statistics:
- Not specified
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- 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 applicable
- True negative controls validity:
- not applicable
- 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 applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH and osmolality: not specified
- Possibility of evaporation from medium: no
- Water solubility: Sufficiently soluble in selected solvent.
- Precipitation and time of the determination: Precipitation of the test material on the agar plates occurred at concentrations ≥ 500 µg/plate.
STUDY RESULTS
- Concurrent vehicle negative and positive control data
Ames test:
- Signs of toxicity: No toxicity was observed.
- Individual plate counts: Please refer to attached document under "Overall remarks, attachments".
- Mean number of revertant colonies per plate and standard deviation: Please refer to “Any other information on results".
HISTORICAL CONTROL DATA
Not specified
Any other information on results incl. tables
Summary 1st series
Metabolic Activation |
Test Material |
Concentr. [µg/plate] |
|
Revertants per plate (Mean ± SD) |
|||||
|
|
|
|||||||
|
|
|
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
|
|
Without Activation |
Acetonene |
|
|
19 ± 6 |
112 ± 11 |
260 ± 24 |
32 ± 5 |
13 ± 3 |
20 ± 4 |
Test material |
5.00 |
|
20 ± 8 |
121 ± 15 |
248 ± 11 |
32 ± 6 |
17 ± 5 |
26 ± 6 |
|
|
15.8 |
|
19 ± 10 |
116 ± 7 |
271 ± 17 |
36 ± 6 |
15 ± 2 |
24 ± 7 |
|
|
50.0 |
|
17 ± 8 |
106 ± 15 |
311 ± 15 |
30 ± 2 |
15 ± 8 |
28 ± 3 |
|
|
158 |
|
16 ± 4 |
113 ± 4 |
328 ± 21 |
30 ± 5 |
15 ± 5 |
28 ± 10 |
|
|
500 |
|
18 ± 6E |
112 ± 12E |
332 ± 11E |
26 ± 4E |
14 ± 4E |
25 ± 6E |
|
|
1580 |
|
19 ± 3E |
110 ± 17E |
270 ± 42E |
26 ± 5E |
9 ± 1E |
26 ± 7E |
|
|
5000 |
|
20 ± 3E |
108 ± 5E |
268 ± 8E |
23 ± 5E |
10 ± 5E |
25 ± 5E |
|
DAUN |
1.00 |
|
241 ± 35 |
|
|
|
|
|
|
NaN3 |
2.00 |
|
|
746 ± 68 |
|
452 ± 32 |
|
|
|
CUM |
200 |
|
|
|
1717 ± 101 |
|
|
|
|
9-AA |
50.0 |
|
|
|
|
|
618 ± 86 |
|
|
NQO |
2.00 |
|
|
|
|
|
|
1275 ± 14 |
|
|
|
|
|
|
|
|
|
|
|
With Activation |
Acetone |
|
|
29 ± 8 |
118 ± 13 |
345 ± 25 |
24 ± 4 |
14 ± 4 |
34 ± 4 |
Test material |
5.00 |
|
38 ± 5 |
110 ± 18 |
351 ± 20 |
23 ± 4 |
20 ± 4 |
33 ± 12 |
|
|
15.8 |
|
28 ± 7 |
102 ± 20 |
380 ± 59 |
20 ± 9 |
17 ± 6 |
30 ± 4 |
|
|
50.0 |
|
28 ± 5 |
108 ± 17 |
391 ± 48 |
25 ± 7 |
20 ± 4 |
37 ± 6 |
|
|
158 |
|
35 ± 8 |
136 ± 8 |
440 ± 23 |
22 ± 4 |
19 ± 4 |
33 ± 5 |
|
|
500 |
|
27 ± 2E |
130 ± 5E |
433 ± 26E |
18 ± 6E |
19 ± 4E |
38 ± 4E |
|
|
1580 |
|
29 ± 4E |
114 ± 11E |
412 ± 31E |
17 ± 2E |
15 ± 4E |
29 ± 4E |
|
|
5000 |
|
23 ± 6E |
99 ± 9E |
397 ± 20E |
18 ± 5E |
10 ± 2E |
36 ± 4E |
|
2-AA |
2.00 |
|
601 ± 35 |
546 ± 158 |
|
134 ± 11 |
|
|
|
2-AA |
5.00 |
|
|
|
|
|
279 ± 26 |
|
|
2-AA |
10.0 |
|
|
|
|
|
|
463 ± 38 |
|
B(a)p |
10.0 |
|
|
|
2454 ± 62 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA CUM B(a)p 9-AA DAUN NQO |
Sodium azide 2-Aminoanthracene Cumene hydroperoxide Benzo[a]pyrene 9-Aminoacridine Daunomycin 4-Nitroquinoline-N-oxide |
E |
Precipitation until end of experiment |
Summary 2nd series
Metabolic Activation |
Test Material |
Concentr. [µg/plate] |
|
Revertants per plate (Mean ± SD) |
|||||
|
|
|
|||||||
|
|
|
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
|
|
Without Activation |
Acetone |
|
|
21 ± 5 |
140 ± 13 |
308 ± 28 |
28 ± 5 |
13 ± 7 |
29 ± 10 |
Test material |
50.0 |
|
22 ± 3 |
137 ± 15 |
367 ± 15 |
28 ± 3 |
13 ± 8 |
33 ± 3 |
|
|
88.9 |
|
26 ± 9 |
137 ± 21 |
335 ± 14 |
29 ± 3 |
8 ± 4 |
32 ± 5 |
|
|
158 |
|
22 ± 2 |
127 ± 9 |
383 ± 36 |
37 ± 14 |
14 ± 1 |
30 ± 7 |
|
|
281 |
|
20 ± 9 |
126 ± 12 |
367 ± 30 |
29 ± 8 |
13 ± 4 |
31 ± 4 |
|
|
500 |
|
28 ± 2E |
127 ± 10E |
388 ± 55E |
40 ± 2E |
19 ± 6E |
37 ± 2E |
|
DAUN |
1.00 |
|
253 ± 17 |
|
|
|
|
|
|
NaN3 |
2.00 |
|
|
843 ± 88 |
|
735 ± 33 |
|
|
|
CUM |
200 |
|
|
|
1543 ± 103 |
|
|
|
|
9-AA |
50.0 |
|
|
|
|
|
702 ± 158 |
|
|
NQO |
2.00 |
|
|
|
|
|
|
1151 ± 104 |
|
|
|
|
|
|
|
|
|
|
|
With Activation |
Acetone |
|
|
30 ± 5 |
96 ± 8 |
293 ± 10 |
20 ± 4 |
17 ± 4 |
37 ± 5 |
Test material |
50.0 |
|
26 ± 2 |
107 ± 10 |
373 ± 20 |
19 ± 3 |
18 ± 6 |
38 ± 12 |
|
|
88.9 |
|
37 ± 9 |
109 ± 8 |
398 ± 24 |
22 ± 7 |
16 ± 3 |
39 ± 5 |
|
|
158 |
|
29 ± 8 |
115 ± 17 |
437 ± 32 |
23 ± 2 |
19 ± 6 |
29 ± 5 |
|
|
281 |
|
37 ± 8 |
110 ± 7 |
420 ± 47 |
22 ± 8 |
18 ± 8 |
38 ± 10 |
|
|
500 |
|
35 ± 1E |
108 ± 24E |
425 ± 35E |
21 ± 3E |
18 ± 8E |
36 ± 11E |
|
2-AA |
2.00 |
|
225 ± 34 |
|
|
101 ± 17 |
|
|
|
2-AA |
5.00 |
|
|
477 ± 100 |
|
|
|
|
|
2-AA |
10.0 |
|
|
|
|
|
190 ± 18 |
296 ± 27 |
|
B(a)p |
10.0 |
|
|
|
797 ± 104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA CUM B(a)p 9-AA DAUN NQO |
Sodium azide 2-Aminoanthracene Cumene hydroperoxide Benzo[a]pyrene 9-Aminoacridine Daunomycin 4-Nitroquinoline-N-oxide |
E |
Precipitation until end of experiment |
Applicant's summary and conclusion
- Conclusions:
- The test item was not mutagenic in the Salmonella typhimurium and Escherichia coli reverse mutation test with and without metabolic activation.
- Executive summary:
The investigations for the mutagenic potential of the test material were performed according to OECD 471 using Salmonella typhimurium tester strains TA 98, TA 100, TA 102, TA 1535, TA 1537 and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. Two independent experimental series were performed. In the two series with S9 mix, 10 % S9 in the S9 mix were used in the 1st and 30 % in the 2nd series, respectively. The test material was dissolved in acetone and tested at concentrations ranging from 5 to 5000 µg/plate. Precipitation of the test material on the agar plates occurred in the concentration range between 500 and 5000 µg/plate. Toxicity to the bacteria was not observed. Each treatment with the test materials used as positive controls led to a clear increase in revertant colonies, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used. In both series of experiments, each performed with and without the addition of rat liver S9 mix as the external metabolizing system, the test material showed no increase in the number of revertants of any bacterial strain. According to the criteria for negative and positive results, the test material was not mutagenic under the described experimental conditions.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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