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EC number: 607-240-0 | CAS number: 23511-73-1
- 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:
- 28 Nov - 8 Dec 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted in 2008
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-phenoxyethyl octanoate
- EC Number:
- 607-240-0
- Cas Number:
- 23511-73-1
- Molecular formula:
- C16H24O3
- IUPAC Name:
- 2-phenoxyethyl octanoate
Constituent 1
Method
- Target gene:
- His operon (S. typhimurium strains)
Trp operon (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:
- Co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and beta-naphtoflavone.
- Test concentrations with justification for top dose:
- Dose range finding test:
3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate with and without metabolic activation for TA100 and WP2uvrA
Main study (experiment 1 and 2):
10, 33, 100, 333 and 1000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test substance is soluble and stable in the vehicle throughout the test
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 2-nitrofluorene (NF; 10 μg/plate in DMSO, -S9, TA98); 2-Amino-anthracene (2-AA; 1 to 10 μg/plate in DMSO, +S9, all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A test substance is considered positive if the total number of revertants is greater than 2 (TA 100) or three (TA 98, TA 1535, TA 1537, WP2uvrA) times the concurrent control. Positive responses should be reproducible in at least one additional independent experiment. All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls.
- Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- 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, but tested up to precipitating concentrations
- 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, but tested up to precipitating concentrations
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At a concentration of 1000 μg/plate and above, the test material precipitated in the medium.
RANGE-FINDING/SCREENING STUDIES: In the range finding test, the test substance was tested up to 5000 µg/plate in the absence and presence of S9 mix in TA100 and WP2uvrA. No reduction of the bacterial lawn and no biologically relevant decrease in the number of revertants were observed. Due to the precipitation of the test substance in medium at a concentration of 1000 µg/plate and above, this concentration was for the main experiment (TA1535, TA1537 and TA98 in experiment 1 and all strains for experiment 2).
COMPARISON WITH HISTORICAL CONTROL DATA: The negative and strain specific positive control values were within laboratory historical control data ranges (table 3, any other information on results)
Any other information on results incl. tables
Table 1. Test results of experiment 1 (plate incorporation) and range finding study (TA100 and WP2 uvrA)
With or without S9-Mix (5%) |
Test substance concentration |
Mean number of revertant colonies per plate |
|
|||
|
(μg/plate) |
(average of 3 plates ± Standard deviation) |
|
|||
|
|
Base-pair substitution type |
cross-linking type |
Frameshift type |
||
|
|
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
– |
0 |
137 ± 1 |
12 ± 3 |
25 ± 6 |
29 ± 3 |
9 ± 3 |
– |
3 |
139 ± 14 |
- |
28 ± 6 |
- |
- |
– |
10 |
133 ± 16 |
10 ± 3 |
24 ± 4 |
31 ± 2 |
6 ± 2 |
– |
33 |
137 ± 9 |
8 ± 2 |
23 ± 4 |
34 ± 5 |
4 ± 2 |
– |
100 |
131 ± 9 |
11 ± 3 |
24 ± 5 |
26 ± 8 |
6 ± 2 |
– |
333 |
132 ± 7 |
7 ± 4 |
26 ± 7 |
27 ± 10 |
5 ± 2 |
– |
1000 |
137 ± 19P |
7 ± 1P |
21 ± 3P |
28 ± 4P |
6 ± 3P |
– |
3330 |
140 ± 9P |
- |
17 ± 1P |
- |
- |
– |
5000 |
129 ± 13P |
- |
23 ± 4P |
- |
- |
Positive controls, -S9 |
Name |
MMS |
SA |
4NQO |
NF |
9AA |
|
Concentrations (μg/plate) |
650 |
5 |
10 |
10 |
60 |
|
|
|
|
|
|
|
|
Mean No. of colonies/plate (average of 3 ± SD) |
1132 ± 23 |
933 ± 31 |
1271 ± 22 |
1122 ± 62 |
357 ± 38 |
+ |
0 |
140 ± 11 |
9 ± 2 |
26 ± 9 |
35 ± 6 |
6 ± 3 |
+ |
3 |
127 ± 8 |
- |
24 ± 3 |
- |
- |
+ |
10 |
125 ± 10 |
9 ± 3 |
27 ± 5 |
37 ± 6 |
6 ± 2 |
+ |
33 |
130 ± 8 |
9 ± 2 |
25 ± 2 |
38 ± 7 |
4 ± 1 |
+ |
100 |
136 ± 6 |
9 ± 4 |
32 ± 7 |
34 ± 4 |
6 ± 1 |
+ |
333 |
117 ± 4 |
7 ± 2 |
26 ± 4 |
34 ± 5 |
6 ± 2 |
+ |
1000 |
125 ± 10P |
5 ± 1P |
26 ± 1P |
34 ± 11P |
6 ± 1P |
+ |
3330 |
106 ± 7P |
- |
24 ± 6P |
- |
- |
+ |
5000 |
102 ± 9P |
- |
21 ± 2P |
- |
- |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Concentrations (μg/plate) |
1 |
2.5 |
10 |
1 |
2.5 |
|
|
|
|
|
|
|
|
Mean No. of colonies/plate (average of 3 ± SD) |
1442 ± 40 |
406 ± 27 |
586 ± 62 |
1075 ± 21 |
539 ± 15 |
Table 2. Test results of experiment 2 (plate incorporation)
With or without S9-Mix (10%) |
Test substance concentration |
Mean number of revertant colonies per plate |
|
|||
|
(μg/plate) |
(average of 3 plates ± Standard deviation) |
|
|||
|
|
Base-pair substitution type |
cross-linking type |
Frameshift type |
||
|
|
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
– |
0 |
106 ± 11 |
12 ± 1 |
23 ± 5 |
29 ± 6 |
6 ± 1 |
– |
10 |
123 ± 24 |
9 ± 2 |
23 ± 2 |
20 ± 5 |
6 ± 1 |
– |
33 |
130 ± 20 |
8 ± 1 |
23 ± 2 |
21 ± 4 |
5 ± 2 |
– |
100 |
103 ± 4 |
9 ± 1 |
26 ± 4 |
20 ± 5 |
3 ± 1 |
– |
333 |
115 ± 6 |
10 ± 3 |
26 ± 4 |
18 ± 7 |
7 ± 4 |
– |
1000 |
112 ± 9P |
10 ± 4P |
21 ± 5P |
21 ± 5P |
6 ± 2P |
Positive controls, -S9 |
Name |
MMS |
SA |
4NQO |
NF |
9AA |
|
Concentrations (μg/plate) |
650 |
5 |
10 |
10 |
60 |
|
|
|
|
|
|
|
|
Mean No. of colonies/plate (average of 3 ± SD) |
921 ± 74 |
1022 ± 31 |
937 ± 20 |
1094 ± 8 |
322 ± 28 |
+ |
0 |
107 ± 4 |
8 ± 3 |
31 ± 5 |
36 ± 8 |
6 ± 2 |
+ |
10 |
94 ± 10 |
11 ± 1 |
29 ± 4 |
33 ± 9 |
4 ± 1 |
+ |
33 |
100 ± 5 |
10 ± 2 |
27 ± 4 |
27 ± 9 |
6 ± 1 |
+ |
100 |
105 ± 8 |
4 ± 1 |
34 ± 3 |
28 ± 2 |
7 ± 1 |
+ |
333 |
116 ± 9 |
8 ± 4 |
30 ± 4 |
23 ± 5 |
4 ± 1 |
+ |
1000 |
82 ± 5P |
9 ± 1P |
36 ± 3P |
13 ± 6P |
5 ± 2P |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Concentrations (μg/plate) |
2.5 |
2.5 |
10 |
1 |
5 |
|
|
|
|
|
|
|
|
Mean No. of colonies/plate (average of 3 ± SD) |
1261 ± 141 |
260 ± 43 |
317 ± 67 |
541 ± 123 |
526 ± 12 |
MMS = methylmethanesulfonate
4NQO = 4-nitroquinoline-N-oxide
9AA = 9-aminoacridine
2AA = 2-Aminoanthracene
SA = sodium azide
NF = 7-nitrofluorene
P = Precipitate
Table 3. Laboratory historical control data
TA1535 | TA1537 | TA98 | TA100 | WP2uvrA | ||||||
Negative control | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 |
Min | 3 | 3 | 3 | 3 | 12 | 12 | 63 | 60 | 4 | 4 |
Max | 28 | 29 | 19 | 21 | 45 | 51 | 194 | 195 | 44 | 44 |
Mean | 12 | 11 | 7 | 6 | 21 | 26 | 119 | 99 | 19 | 20 |
3xSD | 23 | 23 | 92 | 83 | 22 | 19 | 10 | 9 | 14 | 14 |
TA1535 | TA1537 | TA98 | TA100 | WP2uvrA | ||||||
Positive control | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 |
Min | 375 | 58 | 79 | 57 | 286 | 186 | 458 | 228 | 67 | 56 |
Max | 1923 | 538 | 927 | 833 | 1790 | 1703 | 1593 | 2061 | 1403 | 1146 |
Mean | 1061 | 202 | 352 | 370 | 1059 | 736 | 1057 | 1056 | 849 | 315 |
3xSD | 596 | 229 | 389 | 383 | 545 | 935 | 530 | 991 | 892 | 377 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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