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EC number: 309-831-6 | CAS number: 101227-08-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-01-14 to 2015-02-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- 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 liver microsomal fraction, derived from male Wistar rats, phenobarbital (80 mg/kg bw) / ß-naphthoflavone (100 mg/kg bw) induced for three consecutive days by oral route
- Test concentrations with justification for top dose:
- Pre-experiment: 0.00316, 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5, 5.0 µL/plate
Experiment I: 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5, 5.0 µL/plate
Experiment II: 0.0158, 0.050, 0.158, 0.5, 1.58, 5 µL/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity. - Untreated negative controls:
- yes
- Remarks:
- A. dest., treated in the same way as all dose groups
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, treated in the same way as all dose groups
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: S. typhimurium strains TA 100, TA 1535: sodium azide (10µg/plate); S. typhimurium strains TA 98, TA 1537: 4-nitro-o-phenylene-diamine (10 µg/plate for TA 98, 40 µg/plate for TA 1537); E.coli WP2 uvrA: methylmethanesulfonate (1 µg/plate)
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- A. dest., treated in the same way as all dose groups
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, treated in the same way as all dose groups
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- without metabolic actiavation, S thyphimurium TA 98, TA 1537
- Untreated negative controls:
- yes
- Remarks:
- A. dest., treated in the same way as all dose groups
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, treated in the same way as all dose groups
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- other: E. coli WP 2 uvrA
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- A. dest.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2- aminoanthracene (2.5 µg/plate for all S. typhimurium strains, 10 µg/plate for E. coli WP2 uvrA)
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) in the pre-experiment and in experiment I, preincubation in experiment II
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
- Method: clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approx. ≤ 0.5 in relation to the solvent control
OTHER:
The properties of the S. typhimurium and E. coli strains with regard to membrane permeability, ampicillin- and tetracycline-resistance as well as normal spontaneous mutation rates are checked regularly according to Ames et al..
The colonies were counted using a ProtoCOL counter (Meintrup DWS Laborgeräte GmbH, Germany). Tester strains with a low spontaneous mutation frequency (TA 1535 and TA 1537) were counted manually. - Evaluation criteria:
- Evaluation of Mutagenicity:
The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean
values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and E. coli WP2 uvrA the number of reversions is at least twice
as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
as compared to the reversion rate of the solvent control.
According to the OECD guidelines, the biological relevance of the results is the criterion for the
interpretation of results, a statistical evaluation of the results is not regarded as necessary.
A test item producing neither a dose related increase in the number of revertants nor a reproducible
biologically relevant positive response at any of the dose groups is considered to be non-mutagenic
in this system.
Criteria of validity:
A test is considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to ampicillin (TA98, TA100)
- the negative control plates (A. dest.) with and without S9 mix are within the historical control data ranges
-corresponding background growth on both negative control and test plates is observed.
- the positive controls show a distinct enhancement of revertant rates over the control plate.
- at least five different concentrations of each tester strain are analysable. - Statistics:
- A statistical evaluation of the results was not regarded as necessary as the biological relevance of the results is the criterion for the interpretation of results (according to guideline).
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In experiment I toxic effects of the test item were observed in tester strain TA 100 at concentrations of 2.5 μg/plate and higher (with metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test item was observed in all tester strains used in experiment I and II (with and without metabolic activation).
RANGE-FINDING/SCREENING STUDIES: The toxicity of the test item was determind with tester stains TA 98 and TA 100. Toxicity may be detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control.
COMPARISON WITH HISTORICAL CONTROL DATA: The control plates with and without S9 mix were within the historical control data range.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxic effects of the test item were noted in any of the five tester strains used up to the highest
dose group evaluated with and without metabolic activation in experiment I and II, with one exception: In experiment I toxic effects of the test item were observed in tester strain TA 100 at concentrations of 2.5 μg/plate and higher (with metabolic activation). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation
The test substance was considered to be non-mutagenic in this bacterial reverse mutation assay. - Executive summary:
The test item Fatty acids, C16 -18, 2 -butyloctyl esters was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I and experiment II) using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and tester strain E. coli WP2 uvrA. A correction factor of 1.022 was applied to consider purity of the test item.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments: Experiment I: 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 μL/plate Experiment II: 0.0158, 0.050, 0.158, 0.50, 1.58 and 5.0 μL/plate Precipitation of the test item was observed in all tester strains used in experiment I and II (with and without metabolic activation). No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated with and without metabolic activation in experiment I and II, with one exception: In experiment I toxic effects of the test item were observed in tester strain TA 100 at concentrations of 2.5 μg/plate and higher (with metabolic activation).
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Fatty acids, C16-18, 2-butyloctyl esters at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II. The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Fatty acids, C16-18, 2-butyloctyl esters did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Fatty acids, C16-18, 2-butyloctyl esters is considered to be nonmutagenic in this bacterial reverse mutation assay.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 09 Apr - 27 Jul 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Due to the structural similarities and consistent trend in toxicokinetic and (eco)toxicological behaviour, the selected source substances are considered suitable and systemic human health effects and ecotoxicological effects can be directly read-across in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.
- Reason / purpose for cross-reference:
- read-across source
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- 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
- Water solubility: 2-Ethylhexyl oleate was tested beyond the limit of the solubility to obtain adequate cytotoxicity data, the concentration used as the highest test substance concentration for the dose range finding test was 333 µg/mL.
- Precipitation: 2-Ethylhexyl oleate precipitated in the exposure medium at concentrations of 100 µg/mL and above.
RANGE-FINDING/SCREENING STUDIES: In the dose finding test, L5178Y mouse lymphoma cells were treated with a test substance concentration range of 3 to 333 µg/mL in the absence of S9-mix with a 3 and 24-hour treatment period and in the presence of S9-mix with a 3-hour treatment period.
After 3 hours treatment and 24 and 48 hours subculture, no toxicity in the suspension growth was observed up to and including the highest test substance concentration of 333 µg/mL compared to the suspension growth of the solvent control both in the absence of S9-mix and presence of S9-mix.
After 24 hours of treatment and 24-hour subculture, in the absence of S9-mix, no toxicity in the relative suspension growth was observed up to test substance concentration of 333 µg/mL compared to the solvent control.
COMPARISON WITH HISTORICAL CONTROL DATA: The spontaneous mutation frequencies in the solvent-treated control cultures were between the
minimum and maximum value of the historical control data range. See Table 1 to 4. - Remarks on result:
- other: strain/cell type: mouse lymphoma L5178Y cells
- Conclusions:
- Interpretation of results (migrated information):
negative
The source substance 2-ethylhexyl oleate was in the mouse lymphoma test according to OECD 476 negative. - Executive summary:
The source substance 2-ethylhexyl oleate was in the mouse lymphoma test according to OECD 476 negative.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Due to the structural similarities and consistent trend in toxicokinetic and (eco)toxicological behaviour, the selected source substances are considered suitable and systemic human health effects and ecotoxicological effects can be directly read-across in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- lymphocytes: cultured human peripheral lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At a concentration of 33 µg/mL 2-ethylhexyl oleate precipitated in the culture medium
- Other confounding effects: 2-ethylhexyl oleate showed no significant effects on the number of polyploid cells
RANGE-FINDING/SCREENING STUDIES: The highest concentration analysed was selected based on the solubility of the test substance in the culture medium (3 h and 24 h continuous exposure) or on toxicity, inhibition of the mitotic index of about 50% or greater (48 h continuous exposure).
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No cytotoxicity was observed in the duplicate cultures of the 3h exposure time. - Remarks on result:
- other: strain/cell type: cultured human peripheral lymphocytes
- Conclusions:
- Interpretation of results (migrated information):
negative
Both in the absence and presence of S9-mix the similar substance 2-ethylhexyl oleate did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in two independent experiments.
No effects of 2-ethylhexyl oleate on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that the similar substance 2-ethylhexyl oleate does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under the experimental conditions described in this report according to OECD 473. - Executive summary:
Both in the absence and presence of S9-mix the similar substance 2-ethylhexyl oleate did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in two independent experiments. No effects of 2-ethylhexyl oleate on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that ethylhexyl oleate does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under the experimental conditions described in this report.
Referenceopen allclose all
Table 1. Experiment 1: Cytotoxic and mutagenic response of 2-Ethylhexyl oleate in the mouse lymphoma L5178Y test system.
Dose (µg/mL) |
RSG (%) |
CEday2(%) |
RSday2 (%) |
RTG (%) |
Mutation Frequency x 10-6 |
||
Total |
Small |
Large |
|||||
|
Without metabolic activation (3-hour treatment) |
||||||
SC1 |
100 |
89 |
100 |
100 |
100 |
69 |
28 |
SC2 |
100 |
108 |
100 |
100 |
99 |
67 |
28 |
0.03 |
106 |
105 |
107 |
113 |
87 |
63 |
20 |
0.1 |
102 |
101 |
102 |
104 |
76 |
50 |
23 |
0.3 |
88 |
86 |
88 |
77 |
109 |
71 |
34 |
1 |
107 |
99 |
101 |
108 |
99 |
73 |
22 |
3 |
106 |
97 |
98 |
104 |
93 |
64 |
25 |
10 |
103 |
105 |
107 |
110 |
88 |
62 |
22 |
33 |
82 |
111 |
113 |
92 |
133 |
86 |
38 |
100(1) |
82 |
120 |
121 |
100 |
93 |
67 |
22 |
MMS |
66 |
56 |
57 |
37 |
1463 |
939 |
292 |
|
With 8% (v/v) metabolic activation (3-hour treatment) |
||||||
SC1 |
100 |
65 |
100 |
100 |
68 |
41 |
26 |
SC2 |
100 |
67 |
100 |
100 |
58 |
32 |
25 |
0.03 |
96 |
66 |
100 |
96 |
73 |
45 |
26 |
0.1 |
102 |
63 |
95 |
97 |
71 |
39 |
30 |
0.3 |
93 |
67 |
102 |
94 |
71 |
46 |
24 |
1 |
107 |
66 |
100 |
107 |
71 |
40 |
29 |
3 |
108 |
58 |
88 |
95 |
74 |
53 |
20 |
10 |
107 |
53 |
80 |
85 |
74 |
50 |
22 |
33 |
95 |
62 |
94 |
89 |
74 |
43 |
29 |
100(1) |
100 |
54 |
81 |
81 |
68 |
44 |
23 |
CP |
57 |
44 |
66 |
38 |
752 |
574 |
137 |
Note: all calculations were made without rounding off.
RSG = Relative Suspension Growth; CE = Cloning Efficiency; RS = Relative Survival; RTG = Relative Total Growth; SC = Solvent control = Ethanol; MMS Methylmethanesulfonate; CP = Cyclophosphamide.
(1) = 2-Ethylhexyl oleate precipitated in the exposure medium.
Table 2. Experiment 2: Cytotoxic and mutagenic response of 2-Ethyl oleate in the mouse lymphoma L5178Y test system.
Dose (µg/mL) |
RSG (%) |
CEday2(%) |
RSday2 (%) |
RTG (%) |
Mutation Frequency x 10-6 |
||
Total |
Small |
Large |
|||||
|
Without metabolic activation (24-hour treatment) |
||||||
SC1 |
100 |
85 |
100 |
100 |
59 |
35 |
22 |
SC2 |
100 |
93 |
100 |
100 |
63 |
35 |
26 |
0.03 |
119 |
93 |
104 |
124 |
67 |
36 |
29 |
0.1 |
134 |
91 |
103 |
138 |
56 |
34 |
21 |
0.3 |
121 |
115 |
129 |
156 |
40 |
20 |
20 |
1 |
124 |
97 |
109 |
135 |
47 |
35 |
12 |
3 |
105 |
89 |
100 |
105 |
57 |
38 |
18 |
10 |
124 |
94 |
106 |
131 |
52 |
27 |
24 |
33 |
119 |
99 |
112 |
133 |
58 |
31 |
25 |
100(1) |
129 |
97 |
109 |
140 |
44 |
28 |
15 |
MMS |
106 |
81 |
92 |
97 |
503 |
305 |
152 |
|
With 12% (v/v) metabolic activation (3-hour treatment) |
||||||
SC1 |
100 |
76 |
100 |
100 |
102 |
51 |
47 |
SC2 |
100 |
101 |
100 |
100 |
76 |
38 |
35 |
0.03 |
96 |
81 |
92 |
88 |
82 |
44 |
36 |
0.1 |
100 |
80 |
91 |
91 |
82 |
44 |
35 |
0.3 |
103 |
95 |
108 |
111 |
97 |
52 |
41 |
1 |
106 |
101 |
114 |
121 |
70 |
41 |
27 |
3 |
102 |
83 |
94 |
95 |
85 |
40 |
42 |
10 |
96 |
88 |
99 |
95 |
76 |
46 |
28 |
33 |
99 |
81 |
92 |
91 |
89 |
55 |
31 |
100(1) |
98 |
86 |
98 |
96 |
73 |
37 |
34 |
MMS |
62 |
66 |
75 |
46 |
1337 |
776 |
310 |
Table 3. Historical control data of the spontaneous mutation frequencies of the solvent controls of the mouse lymphoma assay.
|
-S9-mix |
+S9-mix |
|
3-hour treatment |
24-hour treatment |
|
|
Range |
[51-120] x 10-6 |
[50-127] x10-6 |
[50-170] x 10-6 |
Mean |
77 x 10-6 |
80 x 10-6 |
92 x 10-6 |
SD |
18 x 10-6 |
19 x10-6 |
33 x10-6 |
n |
88 |
82 |
141 |
SD = Standard deviation
n = Number of observation
The above mentioned historical control data range of the solvent controls were obtained by collecting all data of the solvent control values (media, DMSO, and ethanol) over the period of June 2006 to June 2009.
Table 4. Historical control data of the spontaneous mutation frequencies of the positive controls for the mouse lymphoma assay.
|
-S9-mix |
+S9-mix |
|
3-hour treatment |
24-hour treatment |
|
|
Range |
[518-2052] x 10-6 |
[578-1533] x10-6 |
[724-3715] x 10-6 |
Mean |
1004 x 10-6 |
1063 x 10-6 |
1597 x 10-6 |
SD |
356 x 10-6 |
232 x10-6 |
712 x10-6 |
n |
45 |
34 |
81 |
The above mentioned historical control data range of the positive controls were obtained by collecting all data over the period of June 2006 to June 2009.
Table 1: Cytotoxic and Genotoxic observations
Test item |
Concentration |
Mitotic Index |
Aberrant cells in % |
|
|
in µg/mL |
in % |
with gaps |
without gaps |
Exposure period 3 h, fixation time 24 h, without S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
2 |
2 |
MMC |
0.5 |
67 |
31 |
30 |
Test substance |
3 |
99 |
1 |
1 |
10 |
98 |
2 |
2 |
|
33 |
92 |
1 |
1 |
|
Exposure period 3 h, fixation time 24 h, with S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
1 |
1 |
CP |
0.5 |
51 |
38 |
38 |
Test substance |
3 |
101 |
1 |
1 |
10 |
108 |
0 |
0 |
|
33 |
103 |
3 |
3 |
|
Exposure period 24 h, fixation time 24 h, without S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
1 |
1 |
MMC |
0.2 |
54 |
34 |
33 |
Test substance |
3 |
99 |
1 |
1 |
10 |
103 |
3 |
3 |
|
33 |
70 |
4 |
3 |
|
Exposure period 48 h, fixation time 48 h, without S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
2 |
0 |
MMC |
0.1 |
120 |
51 |
49 |
Test substance |
3 |
108 |
1 |
0 |
10 |
100 |
0 |
0 |
|
33 |
99 |
2 |
2 |
|
Exposure period 3 h, fixation time 48 h, with S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
0 |
0 |
CP |
10.0 |
-- |
44 |
44 |
Test substance |
3 |
100 |
2 |
2 |
10 |
94 |
2 |
2 |
|
33 |
97 |
1 |
0 |
MMC: Mitomycin CP: Cyclophosphamide
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The target substance was considered to be non-mutagenic in a bacterial reverse mutation assay (Ames test) performed according to OECD Guideline 471, with and without metabolic activation.
Both in the absence and presence of S9-mix the source substance 2-ethylhexyl oleate did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in two independent experiments. No effects of 2-ethylhexyl oleate on the number of polyploid cells and cells with endoreduplicated chromosomes were observed in the absence and presence of S9-mix. Therefore it can be concluded that the source substance 2-ethylhexyl oleate does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under the experimental conditions described in this report performed according to OECD Guideline 473.
The source substance 2-ethylhexyl oleate was in the mouse lymphoma test according to OECD Guideline 476 negative.
In conclusion, the results of the available in vitro studies on target and source substances were negative. Based on the available data on target and source substances, and following the analogue approach, Fatty acids, C16-18, 2-butyloctyl esters is not expected to be mutagenic and clastogenic.
Justification for selection of genetic toxicity endpoint
In all available genetic toxicity tests the test substance and the
source substances with and without metabolic activation were not
mutagenic.
Short description of key information:
In all available genetic toxicity tests the test substance and the
source substances with and without metabolic activation were not
mutagenic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The test substance and the similar substances were not mutagenic in any of the available in vitro genetic toxicity tests. Therefore a classification according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 is not required.
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