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EC number: 203-385-5 | CAS number: 106-32-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- 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
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- 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
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- Nanomaterial specific surface area
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- Endpoint summary
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- Environmental data
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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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- 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:
- 15.03.2016 - 08.04.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethyl octanoate
- EC Number:
- 203-385-5
- EC Name:
- Ethyl octanoate
- Cas Number:
- 106-32-1
- Molecular formula:
- C10H20O2
- IUPAC Name:
- ethyl octanoate
Constituent 1
Method
- Target gene:
- - Salmonella typhimurium: histidine (his)
- Escherichia coli: tryptophan (trp)
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:
- S9 Mix
- Test concentrations with justification for top dose:
- Justification dose selection: Minor toxic effects were observed in the pre-experiment.
Experiment I: 3, 10, 33, 100, 333, 1000, 2500 and 5000 μg/plate
Experiment II: 33, 100, 333, 1000, 2500 and 5000 μg/plate for WP2 uvrA and 3, 10, 33, 100, 333, 1000, 2500 and 5000 μg/plate for all remaining strains - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 4-NOPD; 2-aminoanthracene, 2-AA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Preincubation period: 60 minutes at 37 °C
- Exposure duration: 48 hours at 37 °C
DATA EVALUATION
- Counting: Petri Viewer Mk2 (Perceptive Instruments Ltd, Suffolk CB9 7BN, UK) with software program Ames Study Manager (v.1.21)
DETERMINATION OF CYTOTOXICITY
- Method: 8 concentrations were tested for toxicity and mutation induction with each 3 plates. Toxicity of the test item can be evident as a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn. The pre-experiment is reported as main experiment I, since the following criteria are met: Evaluable plates (>0 colonies) at five concentrations or more in all strains used. Since minor toxic effects were observed 7 concentrations were tested and 5000 μg/plate was chosen as maximal concentration in Experiment II.
ACCEPTABILITY CRITERIA
- regular background growth in negative and solvent control
- spontaneous reversion rates in negative and solvent control are in the range of historical data
- positive control substances should produce an increase above the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control
- a minimum of 5 analysable dose levels should be present with at least 3 dose levels showing no signs of toxic effects, evident as a reduction in the number of revertants below the indication factor of 0.5. - Evaluation criteria:
- Test item is considered mutagen if biologically relevant increase in the number of revertants exceeds the threshold (twice or thrice) of the colony count of the corresponding solvent control. A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535 and TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- at 1000 µg/plate without S9 in Experiment II
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate without S9 in Experiment I and at 100 - 5000 µg/plate without S9 and 2500 - 5000 µg/plate with S9 in Experiment II
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- at 5000 µg/plate with S9 in Experiment II
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In experiment II in the absence of S9 mix the induction factor was below the toxic border of 0.5 after treatment with the test item at a concentration of 1000 μg/plate. This effect was judged to be caused by statistical fluctuations of the rather low numbers of colonies in strain TA 1537 and does not represent a true toxic effect.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
The historical range of positive controls was exceeded in strains TA 1535 and TA 98 (Exp. I) with metabolic activation. This effect indicates the sensitivity of the strains rather than compromising the assay.
Any other information on results incl. tables
Summary of individual results of Experiment I
Treatment |
Concentration (µg/plate) |
Revertant Colony counts (mean±SD) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
||
Without metabolic activation |
||||||
DMSO |
n.a. |
15±5 |
8±2 |
32±8 |
158±25 |
43±10 |
Untreated |
n.a. |
17±2 |
8±2 |
31±12 |
164±14 |
51±1 |
Test item |
3 |
13±4 |
10±3 |
30±2 |
160 ± 7 |
40±10 |
10 |
8±1 |
7±1 |
24±3 |
162±9 |
30±7 |
|
33 |
14±2 |
8±3 |
27±4 |
148±32 |
38±3 |
|
100 |
9±3 |
13±1 |
23±4 |
109±4 |
42±6 |
|
333 |
9±4 |
11±1 |
29±1 |
92±7 |
44±1 |
|
1000 |
11±3 |
12±3 |
23±8 |
83±10 |
44±6 |
|
2500 |
8±2 |
11±4 |
23±5 |
83±20 |
40±6 |
|
5000 |
11±4 |
13±3 |
22±3 |
68±21 |
49±2 |
|
NaN3 |
10 |
1229 ± 17 |
|
|
2297 ± 65 |
|
4-NOPD |
10 |
|
|
387±66 |
|
|
4-NOPD |
50 |
|
89±6 |
|
|
|
MMS |
2.0 µL |
|
|
|
|
1028 ± 41 |
With metabolic activation |
||||||
DMSO |
n.a. |
15±3 |
12±6 |
24±5 |
137±18 |
47±7 |
Untreated |
n.a. |
12±3 |
14±5 |
37±10 |
161 ± 9 |
54±9 |
Test item |
3 |
14±2 |
10±2 |
44±10 |
127±10 |
52±4 |
10 |
11±1 |
10±2 |
33±4 |
119 ± 7 |
57±8 |
|
33 |
9±2 |
12±3 |
37±7 |
112 ± 7 |
50±8 |
|
100 |
17±0 |
15±6 |
34±6 |
112±11 |
53±11 |
|
333 |
18±6 |
16±3 |
34±6 |
143 ± 7 |
45±3 |
|
1000 |
14±2 |
14±4 |
40±14 |
163±13 |
48±7 |
|
2500 |
14±1 |
11±4 |
32±4 |
131±14 |
44±7 |
|
5000 |
12±3 |
10±0 |
30 ± 3 |
148 ± 23 |
37 ± 12 |
|
2-AA |
2.5 |
554±67 |
120 ± 21 |
5323 ± 212 |
3057 ± 382 |
|
2-AA |
10 |
|
|
|
|
440 ± 22 |
NaN3 = sodium azide; 2-AA = 2-aminoanthracene; 4-NOPD = 4-nitro-o-phenylene-diamine; MMS = methyl methane sulfonate
Summary of individual results of Experiment II
Treatment |
Concentration (µg/plate) |
Revertant Colony counts (mean±SD) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
||
Without metabolic activation |
||||||
DMSO |
n.a. |
11±3 |
10±3 |
19±3 |
167±8 |
45±3 |
Untreated |
n.a. |
11±5 |
9±4 |
24±4 |
178±20 |
46±3
|
Test item |
3 |
12±2 |
10±3 |
19±2 |
169±16 |
|
10 |
13±3 |
10±4 |
24±5 |
142±16 |
|
|
33 |
9±1 |
9±1 |
22±7 |
118±8 |
51±4
|
|
100 |
10±0 |
10±4 |
23±5 |
69±12 |
39±4 |
|
333 |
10±2 |
8±2 |
16 ± 5 |
61 ± 5R |
33±14 |
|
1000 |
10±2 |
4 ± 0M R |
17 ± 10R |
46±10R |
40±6 |
|
2500 |
10±3 |
5 ± 1M R |
17 ± 4R |
65±21R |
41±4 |
|
5000 |
9±4 |
5 ± 1M R |
9 ± 1M R |
43 ± 1R |
38 ± 8 |
|
NaN3 |
10 |
1194 ± 11 |
|
|
1996 ± 123 |
|
4-NOPD |
10 |
|
|
397 ± 30 |
|
|
4-NOPD |
50 |
|
102±4 |
|
|
|
MMS |
2.0 µL |
|
|
|
|
764±22 |
With metabolic activation |
||||||
DMSO |
n.a. |
12±2 |
11±4 |
33±4 |
131±9 |
49±9 |
Untreated |
n.a. |
12±2 |
10±2 |
37±2 |
200±7 |
51±1 |
Test item |
3 |
13±4 |
8±1 |
36±8 |
123±5 |
|
10 |
10±2 |
8±2 |
28±2 |
126±14 |
|
|
33 |
12±2 |
9±3 |
33±7 |
124±12 |
54±8 |
|
100 |
11±2 |
13±3 |
40±1 |
134±10 |
52±7 |
|
333 |
11±2 |
9±3 |
33±6 |
137±10 |
49±8 |
|
1000 |
11±1 |
7±5 |
35±6 |
116±11 |
49±10 |
|
2500 |
8±2 |
8±3 |
25±3 |
57±9 |
35±4 |
|
5000 |
12±3 |
11 ± 2 |
26 ± 2 |
57 ± 9 |
16 ± 2 |
|
2-AA |
2.5 |
401±33 |
89 ± 15 |
4498 ± 698 |
3034 ± 203 |
|
2-AA |
10 |
|
|
|
|
523 ± 38 |
M = manual count
R = reduced background growth
NaN3 = sodium azide; 2-AA = 2-aminoanthracene; 4-NOPD = 4-nitro-o-phenylene-diamine; MMS = methyl methane sulfonate
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the Salmonella typhimurium and Escherichia coli strains used. Therefore, the test item is considered to be non-mutagenic.
- Executive summary:
In the current study the potential of the test item to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA1535, TA1537, TA98, TA 100, and Escherichia coli strain WP2uvrA was assessed. The study was perfomed according to OECD 471 and GLP.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at 3, 10, 33, 100, 333, 1000, 2500 and 5000 μg/plate in Experiment I and at 33, 100, 333, 1000, 2500 and 5000 μg/plate in Experiment II for WP2 uvrA and at 3, 10, 33, 100, 333, 1000, 2500 and 5000 μg/plate in Experiment II for all remaining strains. No precipitation of the test item occurred up to the highest investigated dose.
The plates incubated with the test item showed reduced background growth in strains TA 1537, TA 98 and TA 100 in the second experiment without metabolic activation. Toxic effects, evident as a reduction in the number of revertants, were observed in strains TA 100 (from 100 to 5000 μg/plate without S9 mix and from 2500 to 5000 μg/plate with S9 mix), TA 1537 (at 1000 μg/plate without S9 mix) and WP2 uvrA (at 5000 μg/plate with S9 mix).
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test item is considered to be non-mutagenic.
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