Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
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:
- From 10 November 2017 to 15 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Ethyl decanoate
- EC Number:
- 203-761-9
- EC Name:
- Ethyl decanoate
- Cas Number:
- 110-38-3
- Molecular formula:
- C12H24O2
- IUPAC Name:
- ethyl decanoate
- Test material form:
- liquid
Constituent 1
- 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
Method
Species / strain
- 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.
Controls
- 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)
Results and discussion
Test resultsopen allclose all
- 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.
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.