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EC number: 263-167-0 | CAS number: 61791-34-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 May - 02 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Economy, Trade and Industry, Japanese Ministry of Health, Labour and Welfare and Japanese Ministry of Agriculture, Forestry and Fisheries
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Onium compounds, morpholinium, 4-ethyl-4-soya alkyl, Et sulfates
- EC Number:
- 263-167-0
- EC Name:
- Onium compounds, morpholinium, 4-ethyl-4-soya alkyl, Et sulfates
- Cas Number:
- 61791-34-2
- Molecular formula:
- Not available for UVCB substance
- IUPAC Name:
- 4-ethyl-4-(hexadecanoyloxy)morpholin-4-ium 4-ethyl-4-[(9E)-octadec-9-enoyloxy]morpholin-4-ium 4-ethyl-4-[(9E,12E)-octadeca-9,12-dienoyloxy]morpholin-4-ium triethyl sulfate
Constituent 1
Method
- Target gene:
- "his operon" (for S. typhimurium strains) and "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 rats treated with phenobarbital and β-naphtha flavone
- Test concentrations with justification for top dose:
- Pre-experiment for toxicity testing: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate for all strains with and without metabolic activation
Based on the results of the pre-experiment, the following concentrations were chosen for the main experiments:
First experiment: 0.05, 0.15, 0.5, 1.5, 5, 15, 50 and 150 µg/plate without metabolic activation for TA 100, TA 1535, TA 98 and TA 1537
First experiment: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate without metabolic activation for WP2uvrA
First experiment: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate with metabolic activation for TA 100, TA 98, TA 1537 and WP2uvrA
First experiment: 0.05, 0.15, 0.5, 1.5, 5, 15, 50 and 150 µg/plate with metabolic activation for TA 1535
Second experiment: 0.015, 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 µg/plate without metabolic activation for TA 100, TA 1535, TA 98 and TA 1537
Second experiment: 0.05, 0.15, 0.5, 1.5, 5, 15, 50 and 150 µg/plate without metabolic activation for WP2uvrA
Second experiment: 0.05, 0.15, 0.5, 1.5, 5, 15, 50 and 150 µg/plate with metabolic activation for TA 100, TA 98 and TA 1537
Second experiment: 0.015, 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 µg/plate with metabolic activation for TA 1535
Second experiment: 0.15, 0.5, 1.5, 5, 15, 50, 150 and 500 µg/plate with metabolic activation for WP2uvrA - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test substance was insoluble in sterile distilled water at 50 mg/mL but fully soluble in DMSO at the same concentration therefore DMSO was selected as the vehicle.
Controls
- 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
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene: +S9: 1, 2 or 10 µg/plate for TA100, TA1535 and TA1537, and WP2uvrA, respectively
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: First Experiment: in agar (plate incorporation); Second Experiment: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: Approximately 48 h (plate incorporation and preincubation method)
NUMBER OF REPLICATIONS: Triplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Reduction of the bacterial background lawn (thinning) - Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response (Cariello and Piegorsch, 1996)).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgment about test item activity. Results of this type will be reported as equivocal. - Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment 1: at 150 µg/plate with and without S9 mix; Experiment 2: at 150 and 50 µg/plate with and without S9 mix, respectively
- Vehicle controls validity:
- valid
- Untreated 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:
- cytotoxicity
- Remarks:
- Experiment 1: at 150 µg/plate with and without S9 mix; Experiment 2: at 15 and 5 µg/plate with and without S9 mix, respectively
- Vehicle controls validity:
- valid
- Untreated 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:
- cytotoxicity
- Remarks:
- Experiment 1: at 500 µg/plate with and without S9 mix; Experiment 2: at 500 and 50 µg/plate with and without S9 mix, respectively
- 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:
- cytotoxicity
- Remarks:
- Experiment 1: at 500 and 150 µg/plate with and without S9 mix; Experiment 2: at 150 and 15 µg/plate with and without S9 mix, respectively
- 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:
- cytotoxicity
- Remarks:
- Experiment 1: at 150 and 50 µg/plate with and without S9 mix, respectively; Experiment 2: at 150 and 5 µg/plate with and without S9 mix, respectively
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test substance was not observed.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: The respective positive control values of all strains were within the range of the historical control data and thus the values were considered as valid (please refer to Table 3 under "any other information on results incl. tables).
- Negative (solvent/vehicle) historical control data: The solvent control values of TA98, WP2uvrA, TA 98 and TA 1537 were within the range of the historical control data and thus the values were considered as valid. Two counts of the solvent control for TA 1535 were just outside the historical control data, but still considered acceptable as the other solvent control counts were within expected range and the tester strain responded very well with the respective positive controls in both the presence and absence of S9-mix (please refer to Table 3 under "any other information on results incl. tables).
Any other information on results incl. tables
Table 1: Results of Experiment I (plate incorporation)
Metabolic Activation | Test Group | Dose Level (µg/plate) | Revertant Colony Counts (Mean ±SD) | ||||
TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 | |||
Without Activation | Deionised water | 81 ± 3.6 | 36 ± 4.6 | 29 ± 13.8 | 30 ± 2.1 | 11 ± 4.9 | |
Test substance | 0.05 | 77 ± 11.5 | 36 ± 4.6 | nt | 20 ± 7.1 | 10 ± 4.0 | |
0.15 | 77 ± 5.1 | 30 ± 2.5 | nt | 17 ± 2.6 | 12 ± 7.5 | ||
0.5 | 69 ± 2.9 | 28 ± 2.1 | nt | 24 ± 3.1 | 11 ± 2.6 | ||
1.5 | 74 ± 8.0 | 26 ± 5.0 | 24 ± 12.2 | 26 ± 5.2 | 11 ± 6.7 | ||
5 | 81 ± 13.6 | 28 ± 1.0 | 26 ± 6.1 | 21 ± 3.5 | 9 ± 5.0 | ||
15 | 86 ± 9.0 | 25 ± 3.8 | 24 ± 2.5 | 28 ± 6.2 | 14 ± 4.5 | ||
50 | 46 ± 11.8 (S) | 27 ± 4.5 | 27 ± 5.1 | 15 ± 2.0 (S) | 0 V | ||
150 | 0 T | 28 ± 2.3 (S) | 18 ± 4.0 (S) | 0 T | 0 T | ||
500 | nt | 0 V | 0 V | nt | nt | ||
1500 | nt | nt | 0 V | nt | nt | ||
5000 | nt | nt | 0 V | nt | nt | ||
ENNG | 3 | 425 ± 46.2 | nt | nt | nt | nt | |
5 | nt | 461 ± 45.9 | nt | nt | nt | ||
2 | nt | nt | 704 ± 38.1 | nt | nt | ||
4NQO | 0.2 | nt | nt | nt | 269 ± 38.0 | nt | |
9AA | 80 | nt | nt | nt | nt | 356 ± 71.6 | |
With Activation | Deionised water | 114 ± 7.5 | 23 ± 7.0 | 38 ± 7.5 | 34 ± 3.6 | 10 ± 2.5 | |
Test substance | 0.05 | nt | 22 ± 2.1 | nt | nt | nt | |
0.15 | nt | 18 ± 3.5 | nt | nt | nt | ||
0.5 | nt | 19 ± 2.6 | nt | nt | nt | ||
1.5 | 108 ± 5.9 | 23 ± 3.1 | 34 ± 1.0 | 21 ± 5.3 | 9 ± 2.9 | ||
5 | 111 ± 6.4 | 20 ± 1.2 | 39 ± 5.5 | 29 ± 10.5 | 9 ± 2.0 | ||
15 | 105 ± 13.0 | 16 ± 4.0 | 41 ± 2.0 | 31 ± 6.1 | 10 ± 3.0 | ||
50 | 93 ± 6.1 | 20 ± 3.2 (S) | 38 ± 7.4 | 19 ± 1.5 | 10 ± 1.0 | ||
150 | 0 V | 0 V | 29 ± 2.5 | 12 ± 6.0 (S) | 0 V | ||
500 | 0 T | nt | 0 V | 0 T | 0 T | ||
1500 | 0 T | nt | 0 T | 0 T | 0 T | ||
5000 | 0 T | nt | 0 T | 0 T | 0 T | ||
2-AA | 1 | 594 ± 168.6 | nt | nt | nt | nt | |
2-AA | 2 | nt | 205 ± 24.6 | nt | nt | 567 ± 11.2 | |
2-AA | 10 | nt | nt | 462 ± 44.7 | nt | nt | |
BP | 5 | nt | nt | nt | 281 ± 2.9 | nt | |
2-AA | 2 | nt | nt | nt | nt | nt |
nt: not tested
2 -AA: 2 -Aminoanthracene
BP: Benzo(a)pyrene
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4 -NQO: 4-Nitroquinoline-1-oxide
9AA: 9-Aminoacridine
T: Toxic, no bacterial background lawn
V: Very weak bacterial background lawn
S: Sparse bacterial background lawn
Table 2: Results of Experiment 2 (preincubation)
Metabolic Activation | Test Group | Dose Level (µg/plate) | Revertant Colony Counts (Mean ±SD) | ||||
TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 | |||
Without Activation | Deionised water | 86 ± 7.0 | 8 ± 1.7 | 26 ± 4.0 | 18 ± 8.1 | 10 ± 4.0 | |
Test substance | 0.015 | 86 ± 9.1 | 10 ± 1.5 | nz | 18 ± 11.9 | 10 ± 1.2 | |
0.05 | 83 ± 12.2 | 9 ± 1.0 | 23 ± 1.5 | 14 ± 6.7 | 9 ± 2.6 | ||
0.15 | 72 ± 4.9 | 8 ± 0.6 | 26 ± 8.1 | 10 ± 3.2 | 12 ± 2.1 | ||
0.5 | 91 ± 10.1 | 10 ± 3.5 | 22 ± 3.8 | 16 ± 3.5 | 7 ± 3.1 | ||
1.5 | 66 ± 9.2 | 8 ± 1.2 (S) | 21 ± 0.6 | 13 ± 3.5 | 6 ± 3.1 | ||
5 | 45 ± 9.6 (S) | 0 V | 27 ± 11.4 | 10 ± 4.0 (S) | 5 ± 1.5 (S) | ||
15 | 39 ± 6.2 (S) | 0 V | 21 ± 9.3 (S) | 0 V | 5 ± 3.5 (S) | ||
50 | 0 V | 0 T | 0 V | 0 T | 0 V | ||
150 | nt | nt | 0 T | nt | nt | ||
ENNG | 3 | 623 ± 54.2 | nt | nt | nt | nt | |
5 | nt | 1165 ± 362.7 | nt | nt | nt | ||
2 | nt | nt | 572 ± 41.2 | nt | nt | ||
4NQO | 0.2 | nt | nt | nt | 136 ± 18.7 | nt | |
9AA | 80 | nt | nt | nt | nt | 106 ± 4.4 | |
With Activation | Deionised water | 80 ± 10.5 | 12 ± 2.6 | 46 ± 3.8 | 24 ± 5.5 | 11 ± 5.0 | |
Test substance | 0.015 | nt | 9 ± 0.6 | nt | nt | nt | |
0.05 | 74 ± 7.8 | 8 ± 0.0 | nt | 27 ± 2.6 | 11 ± 4.2 | ||
0.15 | 70 ± 6.0 | 0 ± 1.7 | 35 ± 4.7 | 22 ± 1.7 | 10 ± 3.5 | ||
0.5 | 81 ± 8.0 | 14 ± 1.5 | 44 ± 3.1 | 16 ± 1.5 | 9 ± 4.6 | ||
1.5 | 85 ± 3.6 | 12 ± 0.6 | 42 ± 3.5 | 14 ± 0.6 | 7 ± 3.5 | ||
5 | 74 ± 6.7 | 8 ± 1.7 | 40 ± 7.5 | 19 ± 2.9 | 9 ± 3.5 | ||
15 | 87 ± 16.9 | 5 ± 1.7 | 37 ± 0.0 | 15 ± 0.6 | 8 ± 5.1 | ||
50 | 76 ± 4.4 | 0 V | 53 ± 3.2 | 22 ± 1.2 | 9 ± 1.5 | ||
150 | 0 V | nt | 39 ± 2.0 | 12 ± 2.0 (S) | 0 V | ||
500 | nt | nt | 0 V | nt | nt | ||
2-AA | 1 | 1173 ± 36.1 | nt | nt | nt | nt | |
2-AA | 2 | nt | 136 ± 4.9 | nt | nt | 180 ± 17.9 | |
2-AA | 10 | nt | nt | 247 ± 14.0 | nt | nt | |
BP | 5 | nt | nt | nt | 204 ± 28.0 | nt | |
2-AA | 2 | nt | nt | nt | nt | nt |
nt: not tested
2 -AA: 2 -Aminoanthracene
BP: Benzo(a)pyrene
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4 -NQO: 4-Nitroquinoline-1-oxide
9AA: 9-Aminoacridine
T: Toxic, no bacterial background lawn
V: Very weak bacterial background lawn
S: Sparse bacterial background lawn
Table 3: Historical Control Data (2016)
Strain | without S9 mix | with S9 mix | |||||||
Min | Max | Mean | SD | Min | Max | Mean | SD | ||
TA 1535 | Solvent control | 8 | 34 | 15 | 4.5 | 8 | 39 | 15 | 5.2 |
Positive control | 84 | 2994 | 854 | 664.9 | 92 | 879 | 240 | 62.1 | |
TA1537 | Solvent control | 3 | 24 | 12 | 3.5 | 4 | 23 | 13 | 3.5 |
Positive control | 95 | 1413 | 406 | 227.0 | 101 | 639 | 290 | 97.7 | |
TA 98 | Solvent control | 8 | 49 | 21 | 4.8 | 12 | 51 | 25 | 5.7 |
Positive control | 100 | 449 | 486 | 49.8 | 96 | 4357 | 188 | 230.8 | |
TA 100 | Solvent control | 63 | 154 | 90 | 14.5 | 66 | 156 | 93 | 14.3 |
Positive control | 21 | 2222 | 724 | 320.4 | 284 | 2994 | 854 | 664.9 | |
WP2uvrA | Solvent control | 10 | 53 | 22 | 5.8 | 13 | 53 | 27 | 6.3 |
Positive control | 107 | 1611 | 718 | 338.6 | 102 | 637 | 240 | 98.2 |
Applicant's summary and conclusion
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