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EC number: 203-761-9 | CAS number: 110-38-3
- 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
Description of key information
Based on the available datas for in vitro bacteria reverse mutation, mammalian cytogenicity and mutagenicity tests of the target and source substances of the category, no genotoxicity was observed for both the tested substances. Hence, the registered substance ethyl decanoate could be considered as not mutagenic for bacteria strain and mammalian cells and not cytogenic using this category approach and according to the CLP criteria.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 November 2017 to 15 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. 16090585
- Expiration date of the lot/batch: 19.09.2018
- Purity test date: 22.09.2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: soluble at 5µL/plate
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was diluted with the vehicle
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel: the test item was diluted with the vehicle for the high dose concentration used and the other concentrations were prepared by serial dilution 1/3
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material) : Test item diluted in vehicle - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: rfa mutation, uvrB deletion (S. typhimurium), uvrA deletion (WP2 pKM101)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Post mitochondrial supernatant( S9) of liver from rats which were treated with Aroclor 1254 intravenously
- Test concentrations with justification for top dose:
- The test item was soluble in the assay final mixture (Corn oil with PBS) at a concentration of 5 μL/plate, with no precipitation signs being observed in the assay final mixture with PBS. On the basis of the solubility and cytotoxicity results of the test item, the C5 selected for the main test was 5 μL/plate. Concentrations C4 to C1 (C4: 1.667 µL/plate; C3: 0.556 µIL/plate ; C2 : 0.158 µL/plate; C1: 0.062 µL/plate) were prepared by 1:3 serial dilutions in the selected solvent from the C5 concentration.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: corn oil with PBS
- Justification for choice of solvent/vehicle:The test item was soluble in the assay final mixture (Corn oil with PBS) at a concentration of 5 μL/plate, with no precipitation signs being observed in the assay final mixture with PBS.
Therefore, the C5 selected for the cytotoxicity assay was 5 μL/plate. - Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
- Cell density at seeding (if applicable): not applicable
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours
SELECTION AGENT (mutation assays): not applicable
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: triplicates were used
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: the revertant colonies were counted by an automatic colony counter
NUMBER OF CELLS EVALUATED: not applicable
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Cytotoxicity evaluation of the test item was based on the decrease in the number of revertant colonies, or a clearing or diminution of the background lawn.
- Any supplementary information relevant to cytotoxicity: Cytotoxicity evaluation of the test item was performed in the S. typhimurium TA100 strain by the direct incorporation procedure and without metabolic activation (S9) using 5 concentrations based on the solubility profile of the test item which ranged from 0,062 up to 5,00 μL/plate. Test item solutions were prepared by 1:3 serial dilution of C5. - Rationale for test conditions:
- The Ames test evaluates the potential of the test item to revert mutations present in amino acid-requiring bacterial strains. The reversion restores the functional capability of the bacteria to synthesize the essential amino acid thus enabling the bacterial culture to grow in the absence of the amino acid required by the parent bacterial strain. The mutagenic or pro-mutagenic potential of the test item is assessed by the increase in the number of revertant colonies upon exposure to the test item relative to the number of spontaneously occurring revertant colonies in the controls.
- Evaluation criteria:
- The criteria used for determining a positive result take into account a dose-response effect in the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system.
A result is considered positive whenever the number of revertants of the test item-treated plates is increased when compared to the solvent-treated plates (2 fold increase for TA98, TA 100 and WP2 and 3 fold increase for TA 1537 and TA1535) - Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle 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:
- no cytotoxicity
- Vehicle 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
: see attached table in section "Any other information on results incl. tables"
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used:No test item related cytotoxic activity was observed in the bacterial system over the concentration range tested of 0,062 up to 5,00 μL/plate. - Conclusions:
- The test item CAPRATE D’ETHYLE does not induce point mutations or frameshifts in the genome of the bacterial strains with or without metabolic activation regardless of the procedure over the concentration range tested. Therefore, the test item CAPRATE D’ETHYLE at an exposure dose range of 0,062 – 5,0 μL/plate is considered to be NON MUTAGENIC / NON PRO- MUTAGENIC under the experimental conditions assayed.
- Executive summary:
The GLP compliant test was performed in accordance with OECD Guideline 471 for the Testing of Chemicals (Bacterial Reverse Mutation Test. Adopted 21st July 1997) in order to assess the potential mutagenicity toxicity on bacteria.
Cytotoxicity evaluation of the test item was performed in the S. typhimurium TA100 strain by the direct incorporation procedure and without metabolic activation with 5 concentrations of the test item based on its solubility profile (ranging from 0,062 to 5,0 μL/plate). No test item related cytotoxic activity was observed at any of the concentrations tested.
On the basis of these results, 5 test item doses ranging from 0,062 to 5,0 μL/plate were assayed in the main test, corn oil mixing with PBS was used as vehicle. Direct incorporation and preincubation method were used, with and without metabolic activation system (S9 fraction, from rats liver induced with intravenous administration of Aroclor 1254). Plates were incubated with test item 48 hours and reverant colonies were counted.
Overall interpretation of the study results suggests that the test item does not induce point mutations or frameshifts in the genome of the bacterial strains with or without metabolic activation regardless of the procedure.
Therefore, the test item CAPRATE D’ETHYLE at an exposure dose range of 0,062 – 5,0 μL/plate is considered to be NON MUTAGENIC / NON PRO- MUTAGENIC under the experimental conditions assayed.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Two experimental studies were performed in order to assess the potential mutagenicity on mammalian cells. None of these chromosome aberration assays were positive. Ethyl linoleate and isopropyl laurate are not considered as mutagenic or clastogenic for mammalian cells. Hence, based on the category approach, the target and source substances are not considered as mutagenic on mammalian cells.
- Executive summary:
According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A read-across category for short chain fatty acid was performed in order to provide informations on ethyl decanoate CAS 110-38-3.
This category was based on common and shared physico-chemical and structural properties as:
- common functional group,
- common precursors and the likehood of common impurities as well as common breakdown products via biological processes, which are chemically structurally similar, and
- constant pattern in the changing of the potency of the properties across the category.
The category substances are fatty acid esters covering chain length C8 to C18 satured or unsatured linked to alcohol including ethanol, isopropanol, octanol, hexanol and 2-ethylhexanol. These substances showed similar physico-chemical properties as very low solubility in water, not volatile, ready biodegradable and high log Kow.
Two experimental studies were performed in order to assess the potential mutagenicity on mammalian cells. None of these chromosome aberration assays were positive. Ethyl linoleate and isopropyl laurate are not considered as mutagenic or clastogenic for mammalian cells.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- 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
- Conclusions:
- Under the experimental conditions of the two performed studies, the tested subtances of the category did not led to mutagenicity effect on mammalian cells. Hence, based on the available experimental studies and on the structural similarities between the substances, it can be stated that the members of the category are not mutagenic for mammalian cells.
- Executive summary:
According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A read-across category for short chain fatty acid was performed in order to provide informations on ethyl decanoate CAS 110-38-3.
This category was based on common and shared physico-chemical and structural properties as:
- common functional group,
- common precursors and the likehood of common impurities as well as common breakdown products via biological processes, which are chemically structurally similar, and
- constant pattern in the changing of the potency of the properties across the category.
The category substances are fatty acid esters covering chain length C8 to C18 satured or unsatured linked to alcohol including ethanol, isopropanol, octanol, hexanol and 2-ethylhexanol. These substances showed similar physico-chemical properties as very low solubility in water, not volatile, ready biodegradable and high log Kow.
Two experimental studies were performed in order to assess the potential mutagenicity on mammalian cells. None of these mouse lymphoma assays were positive. Ethyl linoleate and isopropyl laurate are not considered as mutagenic for mammalian cells.
Referenceopen allclose all
HISTORICAL CONTROLVALUES
|
Metabolic |
|
|
|
|
|
|
|
Reference interval (mean ± 2.58SD) |
|
Strain |
activation |
Control |
Mean |
SD |
Max |
Min |
n |
Max |
Min |
|
TA98 |
(-S9) |
d.i. |
+ |
430 |
71.88 |
633 |
306 |
219 |
616 |
245 |
- |
22 |
4.86 |
42 |
13 |
255 |
35 |
10 |
|||
p.i. |
+ |
414 |
69.17 |
627 |
299 |
219 |
592 |
235 |
||
- |
22 |
4.91 |
48 |
12 |
255 |
35 |
10 |
|||
(+S9) |
d.i. |
+ |
687 |
91.94 |
920 |
357 |
219 |
924 |
450 |
|
- |
24 |
5.67 |
52 |
14 |
258 |
38 |
9 |
|||
p.i. |
+ |
636 |
94.94 |
872 |
382 |
219 |
881 |
392 |
||
- |
24 |
5.53 |
45 |
14 |
258 |
38 |
9 |
|||
TA100 |
(-S9) |
d.i. |
+ |
825 |
79.69 |
1009 |
620 |
219 |
1031 |
619 |
- |
87 |
15.69 |
153 |
46 |
255 |
128 |
47 |
|||
p.i. |
+ |
828 |
82.76 |
1087 |
658 |
219 |
1041 |
614 |
||
- |
89 |
14.78 |
153 |
61 |
255 |
127 |
50 |
|||
(+S9) |
d.i. |
+ |
1615 |
191.90 |
1983 |
1039 |
219 |
2110 |
1120 |
|
- |
93 |
16.77 |
147 |
61 |
258 |
136 |
49 |
|||
p.i. |
+ |
1454 |
211.56 |
1977 |
976 |
219 |
2000 |
908 |
||
- |
92 |
15.81 |
135 |
62 |
258 |
133 |
51 |
|||
TA102 |
(-S9) |
d.i. |
+ |
1082 |
130.79 |
1347 |
939 |
24 |
1419 |
744 |
- |
388 |
49.57 |
483 |
304 |
24 |
516 |
260 |
|||
p.i. |
+ |
1198 |
164.85 |
1590 |
928 |
24 |
1624 |
773 |
||
- |
393 |
39.04 |
470 |
313 |
24 |
494 |
293 |
|||
(+S9) |
d.i. |
+ |
2037 |
182.44 |
2326 |
1687 |
24 |
2507 |
1566 |
|
- |
387 |
49.46 |
475 |
288 |
24 |
515 |
259 |
|||
p.i. |
+ |
2028 |
238.25 |
2667 |
1682 |
24 |
2643 |
1414 |
||
- |
366 |
35.93 |
436 |
291 |
24 |
459 |
273 |
|||
TA1535 |
(-S9) |
d.i. |
+ |
892 |
93.07 |
1162 |
602 |
216 |
1132 |
652 |
- |
19 |
5.10 |
31 |
6 |
252 |
32 |
6 |
|||
p.i. |
+ |
921 |
88.41 |
1167 |
603 |
216 |
1149 |
693 |
||
- |
19 |
4.97 |
37 |
9 |
252 |
32 |
6 |
|||
(+S9) |
d.i. |
+ |
358 |
67.32 |
566 |
122 |
216 |
532 |
185 |
|
- |
19 |
5.32 |
34 |
9 |
255 |
32 |
5 |
|||
p.i. |
+ |
391 |
71.60 |
556 |
165 |
216 |
576 |
206 |
||
- |
19 |
5.10 |
32 |
5 |
255 |
32 |
6 |
|||
TA1537 |
(-S9) |
d.i. |
+ |
187 |
27.26 |
346 |
121 |
219 |
257 |
116 |
- |
6 |
1.90 |
12 |
2 |
255 |
11 |
1 |
|||
p.i. |
+ |
183 |
25.76 |
293 |
123 |
219 |
250 |
117 |
||
- |
6 |
1.85 |
10 |
2 |
255 |
11 |
1 |
|||
(+S9) |
d.i. |
+ |
196 |
28.79 |
295 |
130 |
219 |
271 |
122 |
|
- |
6 |
2.07 |
12 |
2 |
258 |
12 |
1 |
|||
p.i. |
+ |
182 |
30.28 |
299 |
105 |
219 |
260 |
104 |
||
- |
6 |
2.03 |
11 |
2 |
258 |
12 |
1 |
|||
WP2 |
(-S9) |
d.i. |
+ |
1941 |
168.46 |
2315 |
1313 |
213 |
2376 |
1506 |
- |
244 |
40.71 |
351 |
144 |
249 |
349 |
139 |
|||
p.i. |
+ |
2092 |
196.82 |
2759 |
1345 |
213 |
2600 |
1584
|
||
- |
245 |
40.53 |
358 |
160 |
249 |
349 |
140 |
|||
(+S9) |
d.i. |
+ |
2023 |
175.00 |
2985 |
1627 |
213 |
2475 |
1572
|
|
- |
256 |
48.07 |
381 |
117 |
252 |
380 |
132 |
|||
p.i. |
+ |
2011 |
149.25 |
2332 |
1602 |
213 |
2396 |
1626
|
||
- |
258 |
45.45 |
412 |
156 |
252 |
375 |
141 |
d.i.: direct incorporation /p.i.: pre-incubation/ +:referencecontrol / -:solventcontrol / n:number of values
RESULTSOFTHECYTOTOXICITYASSAY
S.typhimurium TA100
|
amount/plate |
revertants/plate |
|
mean SD |
R |
||
Solvent: |
Corn oil |
‐ |
125 122 |
102 |
116.3 12.5 |
‐ |
|
|
|
|
5.000 |
96 109 |
87 |
97.3 11.1 |
0.8 |
|
|
|
1.667 |
104 94 |
107 |
101.7 6.8 |
0.9 |
|
Test item |
µL |
0.556 |
114 108 |
125 |
115.7 8.6 |
1.0 |
|
|
|
0.185 |
108 108 |
110 |
108.7 1.2 |
0.9 |
|
|
|
0.062 |
118 103 |
105 |
108.7 8.1 |
0.9 |
RESULTS OF THE TEST WITHOUT METABOLIC ACTIVATION/DIRECT INCORPORATION PROCEDURE
TA98
amount/plate |
revertants/ plate |
mean |
SD |
R |
|||
Solvent: Corn oil |
‐ |
18 |
31 |
20 |
23.0 |
7.0 |
‐ |
Reference item (µg): 2‐nitrofluorene |
5 |
417 |
395 |
577 |
463.0 |
99.3 |
20.1 |
|
5.000 |
12 |
28 |
23 |
21.0 |
8.2 |
0.9 |
|
1.667 |
26 |
23 |
25 |
24.7 |
1.5 |
1.1 |
Test item / µL |
0.556 |
19 |
18 |
18 |
18.3 |
0.6 |
0.8 |
|
0.185 |
13 |
26 |
23 |
20.7 |
6.8 |
0.9 |
|
0.062 |
19 |
27 |
28 |
24.7 |
4.9 |
1.1 |
TA100
Solvent: |
Corn oil |
‐ |
108 |
102 |
98 |
102.7 |
5.0 |
‐ |
Referenceitem(µg): |
sodiumazide |
2.5 |
947 |
1000 |
983 |
976.7 |
27.1 |
9.5 |
|
5.000 |
110 |
117 |
97 |
108.0 |
10.1 |
1.1 |
|
|
1.667 |
118 |
121 |
107 |
115.3 |
7.4 |
1.1 |
|
Test item µL |
0.556 |
127 |
105 |
96 |
109.3 |
15.9 |
1.1 |
|
|
0.185 |
134 |
138 |
109 |
127.0 |
15.7 |
1.2 |
|
|
0.062 |
110 |
131 |
119 |
120.0 |
10.5 |
1.2 |
TA1535
Solvent: |
Corn oil |
‐ |
19 |
35 |
20 |
24.7 |
9.0 |
‐ |
Referenceitem(µg): |
sodiumazide |
3.5 |
1062 |
1091 |
1042 |
1065.0 |
24.6 |
43.2 |
|
5.000 |
26 |
17 |
20 |
21.0 |
4.6 |
0.9 |
|
|
1.667 |
18 |
27 |
18 |
21.0 |
5.2 |
0.9 |
|
Test item µL |
0.556 |
19 |
16 |
20 |
18.3 |
2.1 |
0.7 |
|
|
0.185 |
15 |
10 |
28 |
17.7 |
9.3 |
0.7 |
|
|
0.062 |
15 |
20 |
18 |
17.7 |
2.5 |
0.7 |
TA1537
Solvent: |
Corn oil |
‐ |
9 |
8 |
8 |
8.3 |
0.6 |
‐ |
Referenceitem(µg): |
9‐aminoacridine |
45 |
168 |
181 |
130 |
159.7 |
26.5 |
19.2 |
|
5.000 |
6 |
8 |
4 |
6.0 |
2.0 |
0.7 |
|
|
1.667 |
13 |
11 |
9 |
11.0 |
2.0 |
1.3 |
|
Test item µL |
0.556 |
10 |
9 |
4 |
7.7 |
3.2 |
0.9 |
|
|
0.185 |
10 |
13 |
7 |
10.0 |
3.0 |
1.2 |
|
|
0.062 |
7 |
9 |
8 |
8.0 |
1.0 |
1.0 |
WP2
Solvent: |
Cornoil |
‐ |
257 |
292 |
240 |
263.0 |
26.5 |
‐ |
Referenceitem(µg): |
4‐nitroquinoline‐N‐oxide |
0.4 |
2050 |
1717 |
1850 |
1872.3 |
167.6 |
7.1 |
|
5.000 |
291 |
289 |
226 |
268.7 |
37.0 |
1.0 |
|
|
1.667 |
338 |
292 |
242 |
290.7 |
48.0 |
1.1 |
|
Test item µL |
0.556 |
294 |
295 |
227 |
272.0 |
39.0 |
1.0 |
|
|
0.185 |
286 |
319 |
228 |
277.7 |
46.1 |
1.1 |
|
|
0.062 |
255 |
289 |
201 |
248.3 |
44.4 |
0.9 |
RESULTS OF THE TEST WITHOUT METABOLIC ACTIVATION/PRE‐INCUBATION PROCEDURE
TA98
amount/plate |
revertants/plate |
mean |
SD |
R |
|||
Solvent: Cornoil |
‐ |
23 |
22 |
14 |
19.7 |
4.9 |
‐ |
Referenceitem(µg): 2‐nitrofluorene |
5 |
450 |
477 |
469 |
465.3 |
13.9 |
23.7 |
|
5.000 |
21 |
19 |
11 |
17.0 |
5.3 |
0.9 |
|
1.667 |
20 |
20 |
13 |
17.7 |
4.0 |
0.9 |
TestitemµL |
0.556 |
18 |
15 |
16 |
16.3 |
1.5 |
0.8 |
|
0.185 |
22 |
25 |
21 |
22.7 |
2.1 |
1.2 |
|
0.062 |
13 |
13 |
15 |
13.7 |
1.2 |
0.7 |
TA100
Solvent: |
Cornoil |
‐ |
92 |
123 |
91 |
102.0 |
18.2 |
‐ |
Referenceitem(µg): |
sodiumazide |
2.5 |
876 |
920 |
830 |
875.3 |
45.0 |
8.6 |
|
5.000 |
99 |
118 |
102 |
106.3 |
10.2 |
1.0 |
|
|
1.667 |
117 |
125 |
114 |
118.7 |
5.7 |
1.2 |
|
Test item µL |
0.556 |
125 |
135 |
106 |
122.0 |
14.7 |
1.2 |
|
|
0.185 |
126 |
110 |
113 |
116.3 |
8.5 |
1.1 |
|
|
0.062 |
121 |
135 |
111 |
122.3 |
12.1 |
1.2 |
TA1535
Solvent: |
Cornoil |
‐ |
16 |
18 |
13 |
15.7 |
2.5 |
‐ |
Referenceitem(µg): |
sodiumazide |
3.5 |
827 |
926 |
869 |
874.0 |
49.7 |
55.8 |
|
5.000 |
19 |
11 |
14 |
14.7 |
4.0 |
0.9 |
|
|
1.667 |
16 |
14 |
10 |
13.3 |
3.1 |
0.9 |
|
Test item µL |
0.556 |
18 |
20 |
10 |
16.0 |
5.3 |
1.0 |
|
|
0.185 |
13 |
13 |
12 |
12.7 |
0.6 |
0.8 |
|
|
0.062 |
12 |
11 |
16 |
13.0 |
2.6 |
0.8 |
TA1537
Solvent: |
Cornoil |
‐ |
9 |
8 |
10 |
9.0 |
1.0 |
‐ |
Referenceitem(µg): |
9‐aminoacridine |
45 |
192 |
203 |
149 |
181.3 |
28.5 |
20.1 |
|
5.000 |
7 |
11 |
6 |
8.0 |
2.6 |
0.9 |
|
|
1.667 |
11 |
5 |
4 |
6.7 |
3.8 |
0.7 |
|
Test item µL |
0.556 |
8 |
2 |
3 |
4.3 |
3.2 |
0.5 |
|
|
0.185 |
7 |
9 |
9 |
8.3 |
1.2 |
0.9 |
|
|
0.062 |
7 |
7 |
7 |
7.0 |
0.0 |
0.8 |
WP2
Solvent: |
Cornoil |
‐ |
255 |
298 |
246 |
266.3 |
27.8 |
‐ |
Referenceitem(µg): |
4‐nitroquinoline‐N‐oxide |
0.4 |
1999 |
2181 |
2018 |
2066.0 |
100.0 |
7.8 |
|
5.000 |
336 |
361 |
267 |
321.3 |
48.7 |
1.2 |
|
|
1.667 |
287 |
316 |
290 |
297.7 |
15.9 |
1.1 |
|
Test item µL |
0.556 |
349 |
289 |
340 |
326.0 |
32.4 |
1.2 |
|
|
0.185 |
336 |
269 |
299 |
301.3 |
33.6 |
1.1 |
|
|
0.062 |
330 |
318 |
282 |
310.0 |
25.0 |
1.2 |
RESULTS OF THE TEST WITH METABOLIC ACTIVATION/DIRECT INCORPORATION PROCEDURE
TA98
amount/plate |
revertants/plate |
mean |
SD |
R |
|||
Solvent: Cornoil |
‐ |
34 |
22 |
25 |
27.0 |
6.2 |
‐ |
Referenceitem(µg): 2‐amino‐anthracene |
1.5 |
695 |
555 |
596 |
615.3 |
72.0 |
22.8 |
|
5.000 |
15 |
12 |
17 |
14.7 |
2.5 |
0.5 |
|
1.667 |
33 |
35 |
23 |
30.3 |
6.4 |
1.1 |
TestitemµL |
0.556 |
24 |
19 |
24 |
22.3 |
2.9 |
0.8 |
|
0.185 |
23 |
24 |
30 |
25.7 |
3.8 |
1.0 |
|
0.062 |
17 |
29 |
18 |
21.3 |
6.7 |
0.8 |
TA100
Solvent: |
Cornoil |
‐ |
118 |
127 |
110 |
118.3 |
8.5 |
‐ |
Referenceitem(µg): |
2‐amino‐anthracene |
2.5 |
1884 |
1759 |
1723 |
1788.7 |
84.5 |
15.1 |
|
5.000 |
95 |
117 |
102 |
104.7 |
11.2 |
0.9 |
|
|
1.667 |
109 |
143 |
106 |
119.3 |
20.6 |
1.0 |
|
TestitemµL |
0.556 |
131 |
111 |
141 |
127.7 |
15.3 |
1.1 |
|
|
0.185 |
118 |
123 |
128 |
123.0 |
5.0 |
1.0 |
|
|
0.062 |
127 |
104 |
104 |
111.7 |
13.3 |
0.9 |
TA1535
Solvent: |
Cornoil |
‐ |
22 |
22 |
24 |
22.7 |
1.2 |
‐ |
Referenceitem(µg): |
2‐amino‐anthracene |
30 |
402 |
366 |
338 |
368.7 |
32.1 |
16.3 |
|
5.000 |
12 |
17 |
8 |
12.3 |
4.5 |
0.5 |
|
|
1.667 |
15 |
19 |
15 |
16.3 |
2.3 |
0.7 |
|
TestitemµL |
0.556 |
16 |
22 |
16 |
18.0 |
3.5 |
0.8 |
|
|
0.185 |
16 |
19 |
19 |
18.0 |
1.7 |
0.8 |
|
|
0.062 |
31 |
13 |
13 |
19.0 |
10.4 |
0.8 |
TA1537
Solvent: |
Cornoil |
‐ |
8 |
8 |
10 |
8.7 |
1.2 |
‐ |
Referenceitem(µg): |
2‐amino‐anthracene |
2.5 |
186 |
216 |
198 |
200.0 |
15.1 |
23.1 |
|
5.000 |
6 |
4 |
12 |
7.3 |
4.2 |
0.8 |
|
|
1.667 |
4 |
10 |
9 |
7.7 |
3.2 |
0.9 |
|
TestitemµL |
0.556 |
13 |
7 |
7 |
9.0 |
3.5 |
1.0 |
|
|
0.185 |
8 |
13 |
2 |
7.7 |
5.5 |
0.9 |
|
|
0.062 |
12 |
6 |
6 |
8.0 |
3.5 |
0.9 |
WP2
Solvent: |
Cornoil |
‐ |
241 |
266 |
305 |
270.7 |
32.3 |
‐ |
Referenceitem(µg): |
2‐amino‐anthracene |
30 |
1870 |
1620 |
1757 |
1749.0 |
125.2 |
6.5 |
|
5.000 |
308 |
247 |
259 |
271.3 |
32.3 |
1.0 |
|
|
1.667 |
309 |
382 |
221 |
304.0 |
80.6 |
1.1 |
|
TestitemµL |
0.556 |
361 |
335 |
302 |
332.7 |
29.6 |
1.2 |
|
|
0.185 |
337 |
378 |
301 |
338.7 |
38.5 |
1.3 |
|
|
0.062 |
253 |
249 |
200 |
234.0 |
29.5 |
0.9 |
RESULTS OF THE TEST WITH METABOLIC ACTIVATION/PRE‐INCUBATION PROCEDURE
TA98
amount/plate |
revertants/plate |
mean |
SD |
R |
|||
Solvent: Cornoil |
‐ |
29 |
15 |
19 |
21.0 |
7.2 |
‐ |
Referenceitem(µg): 2‐amino‐anthracene |
1.5 |
811 |
639 |
703 |
717.7 |
86.9 |
34.2 |
|
5.000 |
29 |
13 |
29 |
23.7 |
9.2 |
1.1 |
|
1.667 |
28 |
15 |
26 |
23.0 |
7.0 |
1.1 |
TestitemµL |
0.556 |
32 |
28 |
27 |
29.0 |
2.6 |
1.4 |
|
0.185 |
27 |
28 |
21 |
25.3 |
3.8 |
1.2 |
|
0.062 |
26 |
22 |
23 |
23.7 |
2.1 |
1.1 |
TA100
Solvent: |
Cornoil |
‐ |
128 |
106 |
114 |
116.0 |
11.1 |
‐ |
Referenceitem(µg): |
2‐amino‐anthracene |
2.5 |
1633 |
1461 |
1590 |
1561.3 |
89.5 |
13.5 |
|
5.000 |
86 |
79 |
78 |
81.0 |
4.4 |
0.7 |
|
|
1.667 |
89 |
107 |
94 |
96.7 |
9.3 |
0.8 |
|
TestitemµL |
0.556 |
102 |
101 |
96 |
99.7 |
3.2 |
0.9 |
|
|
0.185 |
93 |
85 |
92 |
90.0 |
4.4 |
0.8 |
|
|
0.062 |
87 |
118 |
110 |
105.0 |
16.1 |
0.9 |
TA1535
Solvent: |
Cornoil |
‐ |
17 |
29 |
23 |
23.0 |
6.0 |
‐ |
Referenceitem(µg): |
2‐amino‐anthracene |
30 |
413 |
365 |
383 |
387.0 |
24.2 |
16.8 |
|
5.000 |
10 |
26 |
13 |
16.3 |
8.5 |
0.7 |
|
|
1.667 |
16 |
14 |
15 |
15.0 |
1.0 |
0.7 |
|
TestitemµL |
0.556 |
21 |
23 |
19 |
21.0 |
2.0 |
0.9 |
|
|
0.185 |
24 |
15 |
30 |
23.0 |
7.5 |
1.0 |
|
|
0.062 |
20 |
17 |
18 |
18.3 |
1.5 |
0.8 |
TA1537
Solvent: |
Cornoil |
‐ |
7 |
7 |
11 |
8.3 |
2.3 |
‐ |
Referenceitem(µg): |
2‐amino‐anthracene |
2.5 |
221 |
231 |
222 |
224.7 |
5.5 |
27.0 |
|
5.000 |
5 |
5 |
4 |
4.7 |
0.6 |
0.6 |
|
|
1.667 |
8 |
5 |
3 |
5.3 |
2.5 |
0.6 |
|
TestitemµL |
0.556 |
5 |
11 |
6 |
7.3 |
3.2 |
0.9 |
|
|
0.185 |
9 |
8 |
4 |
7.0 |
2.6 |
0.8 |
|
|
0.062 |
13 |
4 |
8 |
8.3 |
4.5 |
1.0 |
WP2
Solvent: |
Cornoil |
‐ |
283 |
278 |
232 |
264.3 |
28.1 |
‐ |
Referenceitem(µg): |
2‐amino‐anthracene |
30 |
1979 |
1893 |
1746 |
1872.7 |
117.8 |
7.1 |
|
5.000 |
316 |
341 |
227 |
294.7 |
59.9 |
1.1 |
|
|
1.667 |
347 |
240 |
237 |
274.7 |
62.7 |
1.0 |
|
TestitemµL |
0.556 |
329 |
329 |
240 |
299.3 |
51.4 |
1.1 |
|
|
0.185 |
313 |
318 |
274 |
301.7 |
24.1 |
1.1 |
|
|
0.062 |
264 |
262 |
234 |
253.3 |
16.8 |
1.0 |
Table 1: Results of the key studies performed on the source substances of the category
Common name |
CAS |
Fatty acid chain length |
Type of alcohol |
MW |
Appareance |
In vitro gene cytogenicity study in mammalian cells |
Ethyl decanoate |
110-38-3 |
C10 |
ethanol |
200.32 |
Liquid |
No data |
Ethyl undecylenate |
692-86-4 |
C11 |
ethanol |
212.33 |
liquid |
No data |
Isopropyl laurate |
10233-13-3 |
C12 |
Isopropanol |
242,41 |
Liquid |
Experimental result: |
Octyloctanoate |
2306-88-9 |
C8 |
octanol(C8) |
256,42 |
Liquid |
no data |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
no data |
Dodecanoic hexylester |
34316-64-8 |
C12 |
Hexanol(C6) |
284,49 |
Liquid |
no data |
Ethyl linoleate |
544-35-4 |
C18:2 |
ethanol |
308,5 |
Liquid |
Experimental result: |
Ethyloleate |
111-62-6 |
C18:1 |
ethanol |
310.52 |
Liquid |
no data |
2-ethylhexyl laurate |
20292-08-4 |
C12 |
2-Ethyl-Hexanol |
312,53 |
Liquid |
no data |
Fatty acids, coco, 2-ethylhexyl esters |
92044-87-6 |
C12-14 |
2-ethylhexanol |
312.53 – |
liquid |
No data |
Two experimental studies were performed in order to assess the potential cytogenicity on mammalian cells. None of these chroçmosome aberration tests were positive.Ethyl linoleate and isopropyl laurate are not considered as clastogenic for mammalian cells.
Based on the structural similarities between source and target chemicals and their common toxicokinetic behavior, the target substance was considered as not mutagenic or clastogenic in in vitro cytogenicity test on mammalian cells. These experimental studies are consistent with the low toxicity expected for these substances.
Table 1: Results of the key studies performed on the source substances of the category
Common name |
CAS |
Fatty acid chain length |
Type of alcohol |
MW |
Appareance |
In vitro gene mutation study in mammalian cells |
Ethyl decanoate |
110-38-3 |
C10 |
ethanol |
200.32 |
Liquid |
No data |
Ethylundecylenate |
692-86-4 |
C11 |
ethanol |
212.33 |
liquid |
No data |
Isopropyl laurate |
10233-13-3 |
C12 |
Isopropanol |
242,41 |
Liquid |
Experimental result: |
Octyloctanoate |
2306-88-9 |
C8 |
octanol(C8) |
256,42 |
Liquid |
no data |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
no data |
Dodecanoic hexylester |
34316-64-8 |
C12 |
Hexanol(C6) |
284,49 |
Liquid |
no data |
Ethyl linoleate |
544-35-4 |
C18:2 |
ethanol |
308,5 |
Liquid |
Experimentalresult: |
Ethyl oleate |
111-62-6 |
C18:1 |
ethanol |
310.52 |
Liquid |
no data |
2-ethylhexyl laurate |
20292-08-4 |
C12 |
2-Ethyl-Hexanol |
312,53 |
Liquid |
no data |
Fatty acids, coco, 2-ethylhexyl esters |
92044-87-6 |
C12-14 |
2-ethylhexanol |
312.53 – |
liquid |
No data |
Two experimental studies were performed in order to assess the potential mutagenicity on mammalian cells. None of these mouse lymphoma assays were positive. Ethyl linoleate and isopropyl laurate are not considered as mutagenic for mammalian cells.
Based on the structural similarities between source and target chemicals and their common toxicokinetic behavior, the target substance was considered as not mutagenic in in vitro mutation test on mammalian cells. These experimental studies are consistent with the low toxicity expected for these substances.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No positive effect was observed on in vitro mutagenicity test on bacteria, mammalian cells and clastogenicity test on mammalian cells. Hence, according to REACh requirement, no in vivo study is required to assess mutagenicity of the target substance.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
This category groups covers esters (including ethanol, isopropanol, octanol, hexanol and 2-ethylhexanol) linked to fatty acids chain satured and unsatured (C8 to C18). This category includes monoconstituent substances and UVCB substances varying fatty acid chain length and based on the alcohol sources. This category group was made in order to provide sufficient information for physico-chemical, environmental, ecotoxicological and toxicological caracterisation of ethyl decanoate (CAS 110-38-3). This approach covers these endpoints including skin irritation, eye irritation, and in vitro gene mutation study in bacteria for which some data on the target substance of the category are available.
This category includes:
- Target substance:
o Ethyl decanoate (CAS 110-38-3)
- Source substances:
o Ethyl undecylenate (CAS 692-86-4)
o Isopropyl laurate (CAS 10233-13-3)
o Octyl octanoate (CAS 2306-88-9)
o Isopropyl myristate (CAS 110-27-0)
o Dodecanoic hexyl ester (CAS 34316-64-8)
o Ethyl linoleate (CAS 544-35-4)
o Ethyl oleate (CAS 111-62-6)
o 2 -ethylhexyl laurate (CAS 20292-08-4)
o Fatty acids, coco, 2-ethylhexyl esters (CAS 92044-87-6)
Summary of available study on the target substance (Ames)
The GLP compliant test was performed in accordance with OECD Guideline 471 for the Testing of Chemicals (Bacterial Reverse Mutation Test. Adopted 21st July 1997) in order to assess the potential mutagenicity toxicity of ethyl decanoate on bacteria. Cytotoxicity evaluation of the test item was performed in the S. typhimurium TA100 strain by the direct incorporation procedure and without metabolic activation with 5 concentrations of the test item based on its solubility profile (ranging from 0,062 to 5,0 μL/plate). No test item related cytotoxic activity was observed at any of the concentrations tested.
On the basis of these results, 5 test item doses ranging from 0,062 to 5,0 μL/plate were assayed in the main test, corn oil mixing with PBS was used as vehicle. Direct incorporation and preincubation method were used, with and without metabolic activation system (S9 fraction, from rats liver induced with intravenous administration of Aroclor 1254). Plates were incubated with test item 48 hours and reverant colonies were counted. Overall interpretation of the study results suggests that the test item ethyl decanoate/ethyl caprate does not induce point mutations or frameshifts in the genome of the bacterial strains with or without metabolic activation regardless of the procedure.
Summary of available studies on source substance for mutagnicity/cytogenicity on mammalian cells
Isopropyl laurate CAS 10233-13-3
An mouse lymphoma assay was performed on isopropyl laurate in order to assess the potential mutagenicity of the substance on mammalian cells. The experimental study was performed according to OECD TG 476 method, using mouse lymphoma L5178Y cells. The cells were incubated in medium with test substance at 0.01, 0.03, 0.1, 0.3, 1, 3, 5 and 10 μg/mL during 3 and 24 hours. Metabolic activation system was used or not. After 2 days on expression time, cells were selected with trifluorothymidine. Cytotoxicity was evaluated too. No significant increase in the mutation frequency at the TK locus was observed after treatment with isopropyl laurate either in the absence or in the presence of metabolic activation system.
Additionnaly, a chromosome aberration test was performed according to OECD TG 473 method. Cultured peripheral human lymphocytes were used and exposed to 66 to 250 µg/mL for 24 and 48 hours exposure period with and without metabolic activation system. The vehicle used was ethanol. Cyclophosphamide and mitomycin C were used as positive control. Both in the absence and presence of S9-mix isopropyl laurate did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations.
Ethyl linoleate CAS 544 -35-4
An mouse lymphoma assay was performed on ethyl linoleate in order to assess the potential mutagenicity of the substance on mammalian cells. The experimental study was performed according to OECD TG 476 method, using mouse lymphoma L5178Y cells. The cells were incubated in medium with test substance at different concentrations up to 300 µg/mL during 3 hours in a first experiment and 24 hours in a second experiment. Metabolic activation system was used or not. After 2 days on expression time, cells were selected with trifluorothymidine during 12 days. Cytotoxicity was evaluated too. No significant increase in the mutation frequency at the TK locus was observed after treatment with ethyl linoleate either in the absence or in the presence of metabolic activation system.
A chromosome aberration test was performed according to OECD TG 473 method. Cultured peripheral human lymphocytes were used and exposed up to 333 µg/mL in a first experiment for 3 hours. In a second experiment, cells were exposed up to 800 µg/mL for 24 hours with and without metabolic activation system with 48 hours fixation time. The vehicle used was DMSO. Cyclophosphamide and mitomycin C were used as positive control. Both in the absence and presence of metabolic activation system, ethyl linoleate did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations.
Additionally, the results from studies performed on ethyl decanoate are consistent with negative results from source substances studies. The very similar behavior for mutagenicity reinforces the category approach.
Justification for classification or non-classification
Based on the available datas for in vitro bacteria reverse mutation, mammalian cytogenicity and mutagenicity tests of the target and source substances of the category, no genotoxicity was observed for both the tested substances. Hence, the registered substance ethyl decanoate could be considered as not mutagenic for bacteria strain and mammalian cells and not cytogenic using this category approach and according to the CLP criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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