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EC number: 606-384-1 | CAS number: 19797-08-1
- 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:
- 26 Mar - 16 Apr 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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)
- Version / remarks:
- adopted May 2008
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-ethylazepan-2-one
- EC Number:
- 606-384-1
- Cas Number:
- 19797-08-1
- Molecular formula:
- C8H15NO
- IUPAC Name:
- 1-ethylazepan-2-one
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium strains) and trp operon (E. coli strains)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- The dose-range finding test served as Experiment 1.
Experiment 1: 52, 164, 512, 1600 and 5000 µg/plate with and without metabolic activation
Experiment 2: 52, 164, 512, 1600 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Milli-Q water
- Justification for choice of solvent/vehicle: The test item was miscible in Milli-Q water at 25 °C and stable for at least 24 h at room temperature under normal laboratory light conditions, for at least 8 days in refrigerator (2-8°C) and for at least 3 weeks in the freezer (≤ -15°C), which was confirmed over the concentration range 1 to 60 mg/mL (project # 20144290 at the same testing facility).
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: -S9: 4-nitroquinoline N-oxide 10 µg/plate for WP2uvrA and ICR-191 2.5 µg/plate for TA1537 (Exp. 1); +S9: 2-aminoanthracene 1, 2.5 or 15 µg/plate for all strains
- Remarks:
- Each S9 batch was characterized with the mutagens benzo-(a)-pyrene and 2-aminoanthracene, which require metabolic activation, in tester strain TA100 at concentrations of 5 μg/plate and 2.5 μg/plate, respectively.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, Experiment 1); preincubation (Experiment 2)
DURATION
- Preincubation period: 30 ± 2 min (Experiment 2)
- Exposure duration: 48 ± 4 h (Experiment 1 and 2)
NUMBER OF REPLICATIONS: triplicates each in 2 independant experiments
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were observed. - Evaluation criteria:
- A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA1535, TA1537, TA98, TA100 and E. coli WP2
- 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
- Precipitation: The test item did not precipitate in the incubation medium at the start or at the end of the incubation period in any tester strain.
RANGE-FINDING/SCREENING STUDIES: Experiment 1 served as range-finding study.
HISTORICAL CONTROL DATA
- Positive historical control data: The positive control values were within the range of the historical control data (please refer to table 4 under "any other information on results incl. tables").
- Negative (solvent/vehicle) historical control data: The negative control values were within the range of the historical control data (please refer to table 4 under "any other information on results incl. tables").
Any other information on results incl. tables
Table 1: Results of dose-range finding study/Experiment 1 (direct plate assay)
Mean number of revertant colonies/3 replicate plates (± S.D.) with oneSalmonella typhimuriumand oneEscherichia colistrain. | ||
Without S9-mix | TA100 | WP2uvrA |
Positive control | 1040± 42 | 1093 ± 98 |
Solvent control | 123 ± 13 | 36 ± 8 |
1.7 | 123 ± 4 | 31 ± 7 |
5.4 | 132 ± 18 | 26 ± 6 |
17 | 117 ± 5 | 36 ± 5 |
52 | 105 ± 7 | 34 ± 4 |
164 | 124 ± 23 | 32 ± 8 |
512 | 123 ± 12 | 41 ± 8 |
1600 | 123 ± 27 | 44 ± 6 |
5000 | 121 ± 8 | 33 ± 6 |
With S9-mix | TA100 | WP2uvrA |
Positive control | 1513 ± 3 | 401 ± 118 |
Solvent control | 141 ± 12 | 40 ± 4 |
1.7 | 128 ± 14 | 41 ± 8 |
5.4 | 122 ± 13 | 45 ± 4 |
17 | 108 ± 11 | 47 ± 7 |
52 | 110 ± 16 | 36 ± 6 |
164 | 114 ± 13 | 32 ± 6 |
512 | 103 ± 11 | 34 ± 9 |
1600 | 116 ± 10 | 36 ± 3 |
5000 | 91 ± 8 | 31 ± 6 |
Table 2: Results of Experiment 1 (direct plate assay)
Mean number of revertant colonies/3 replicate plates (± S.D.) with one Salmonella typhimurium and one Escherichia coli strain. | |||
Without S9-mix | TA1535 | TA1537 | Ta98 |
Positive control | 1073 ± 97 | 1036 ± 50 | 1058 ± 40 |
Solvent control | 8 ± 2 | 3 ± 2 | 15 ± 4 |
52 | 8 ± 1 | 6 ± 3 | 16 ± 1 |
164 | 12 ± 5 | 5 ± 5 | 20 ± 6 |
512 | 11 ± 4 | 4 ± 1 | 15 ± 6 |
1600 | 8 ± 7 | 6 ± 2 | 21 ± 2 |
5000 | 8 ± 4 | 7 ± 5 | 16 ± 6 |
With S9-mix | TA1535 | TA1537 | Ta98 |
Positive control | 349 ± 22 | 471 ± 37 | 1181 ± 40 |
Solvent control | 10 ± 2 | 3 ± 2 | 20 ± 5 |
52 | 12 ± 2 | 11 ± 4 | 30 ± 11 |
164 | 12 ± 7 | 9 ± 9 | 26 ± 3 |
512 | 14 ± 2 | 7 ± 0 | 23 ± 8 |
1600 | 7 ± 7 | 4 ± 5 | 22 ± 3 |
5000 | 10 ± 1 | 5 ± 2 | 18 ± 2 |
Table 3: Results of Experiment 2 (pre-incubation assay)
Mean number of revertant colonies/3 replicate plates (± S.D.) with one Salmonella typhimurium and one Escherichia coli strain. | |||||
Without S9-mix | TA1535 | TA1537 | TA98 | TA100 | WP2uvrA |
Positive control | 1164 ± 79 | 145 ± 15 | 1147 ± 80 | 765 ± 93 | 217 ± 85 |
Solvent control | 8 ± 4 | 3 ± 2 | 18 ± 2 | 109 ± 15 | 29 ± 6 |
52 | 12 ± 6 | 3 ± 1 | 11 ± 4 | 104 ± 14 | 32 ± 5 |
164 | 11 ± 4 | 6 ± 3 | 22 ± 19 | 105 ± 12 | 36 ± 8 |
512 | 15 ± 4 | 5 ± 5 | 17 ± 5 | 110 ± 17 | 31 ± 3 |
1600 | 17 ± 13 | 5 ± 2 | 16 ± 6 | 106 ± 17 | 34 ± 6 |
5000 | 4 ± 0 | 5 ± 2 | 15 ± 5 | 114 ± 9 | 39 ±8 |
With S9-mix | |||||
Positive control | 283 ± 20 | 217 ± 21 | 898 ± 85 | 1801 ± 423 | 477 ± 5 |
Solvent control | 21 ± 9 | 12 ± 2 | 35 ± 6 | 110 ± 0 | 39 ± 8 |
52 | 20 ± 5 | 12 ± 4 | 32 ± 4 | 128 ± 14 | 38 ± 4 |
164 | 16 ± 2 | 18 ± 4 | 29 ± 2 | 106 ± 9 | 43 ± 5 |
512 | 19 ± 4 | 13 ± 4 | 34 ± 5 | 106 ± 20 | 39 ± 8 |
1600 | 14 ± 4 | 15 ± 4 | 29 ± 6 | 104 ± 2 | 46 ± 6 |
5000 | 21 ± 1 | 12 ± 3 | 27 ± 3 | 97 ± 13 | 38 ± 4 |
Table 4: Historical control data of the positive and negative control
TA1535 | TA1537 | TA98 | TA100 | WP2uvrA | ||||||
Positive control | ||||||||||
S9-mix | - | + | - | + | - | + | - | + | - | + |
Range | 125 – 1248 | 73 – 1206 | 55 – 1353 | 54 – 1051 | 365 – 1995 | 250 – 1977 | 439 – 1848 | 408 - 2651 | 93 – 1951 | 111 - 1359 |
Mean | 846 | 219 | 787 | 353 | 1406 | 887 | 901 | 1232 | 1094 | 437 |
SD | 146 | 119 | 345 | 162 | 258 | 349 | 168 | 343 | 477 | 149 |
n | 2348 | 2229 | 2003 | 2234 | 2200 | 2276 | 2335 | 2327 | 2021 | 2085 |
Negative control | ||||||||||
S9-mix | - | + | - | + | - | + | - | + | - | + |
Range | 3 – 29 | 3 - 27 | 3 – 20 | 3 – 23 | 8 - 41 | 8 - 55 | 63 – 176 | 54 - 160 | 10 – 59 | 9 - 69 |
Mean | 10 | 11 | 6 | 7 | 16 | 23 | 108 | 107 | 25 | 32 |
SD | 3 | 4 | 2 | 3 | 5 | 7 | 19 | 20 | 7 | 8 |
n | 2356 | 2336 | 2264 | 2235 | 2319 | 2360 | 2341 | 2336 | 2075 | 2078 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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