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EC number: 240-610-6 | CAS number: 16545-00-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
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:
- Bis[2-(diethylamino)ethyl] adipate
- EC Number:
- 240-610-6
- EC Name:
- Bis[2-(diethylamino)ethyl] adipate
- Cas Number:
- 16545-00-9
- Molecular formula:
- C18H36N2O4
- IUPAC Name:
- 1,6-bis[2-(diethylamino)ethyl] hexanedioate
- Reference substance name:
- 2-diethylaminoethanol
- EC Number:
- 202-845-2
- EC Name:
- 2-diethylaminoethanol
- Cas Number:
- 100-37-8
- Molecular formula:
- C6H15NO
- IUPAC Name:
- 2-(diethylamino)ethanol
- Test material form:
- liquid
Constituent 1
impurity 1
Method
- Target gene:
- hisD6610
hisD3052
hisG46
hisG428
uvrB
rfa
pKM101
pAQ1
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 5000 µg/plate, 2500 µg/plate, 1250 µg/plate, 625 µg/plate, 313 µg/plate and 156 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: Amino-Anthracene, 4-Nitro-1,2-phenylene Diamine
- Details on test system and experimental conditions:
- Salmonella typhimurium (all strains used) were obtained from TRINOVA BioChem GmbH (batch of the bacteria strains: TA97a: 4997D, TA98: 5011D, TA100: 4996D, TA102: 4982D, TA1535: 5012D) and were stored as lyophilizates in the fridge at 2-8 °C.
The lyophilizates were used to prepare permanent cultures which were filled into vials and stored at < - 75 °C.
Eight hours before the start of each experiment, an aliquot of a permanent culture per strain to be used was taken from the deep freezer to inoculate a culture vessel containing nutrient broth. After incubation, overnight for eight hours at 37 ± 1 °C, the cultures were used in the experiment. During the test, the cultures were stored at room temperature as to prevent changes in the titre. - Statistics:
- The colonies were counted visually and the numbers were recorded. A validated spread-sheet software (Microsoft Excel®) was used to calculate mean values and standard devia-tions of each treatment, solvent control and positive control.
The mean values and standard deviations of each threefold determination was calculated as well as the increase factor f(l) of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls. Additionally, the absolute number of revertants (Rev. Abs.) (mean revertants minus mean spontaneous revertants) was given. A substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- 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
Any other information on results incl. tables
Table8.1‑a Mean Revertants First Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
100 |
98 |
14 |
14 |
79 |
97 |
225 |
289 |
13 |
15 |
sd |
21.9 |
4.4 |
4.6 |
4.0 |
3.6 |
4.6 |
13.3 |
12.9 |
3.1 |
3.5 |
|
DMSO |
Mean |
79 |
94 |
13 |
16 |
85 |
89 |
245 |
341 |
14 |
12 |
sd |
4.6 |
12.2 |
2.1 |
4.4 |
10.1 |
15.7 |
16.3 |
20.5 |
1.0 |
2.5 |
|
Positive |
Mean |
481 |
431 |
397 |
50 |
339 |
984 |
851 |
1040 |
240 |
90 |
sd |
117.1 |
98.7 |
63.8 |
10.5 |
44.6 |
110.0 |
110.9 |
224.4 |
28.8 |
13.6 |
|
f(I) |
6.09 |
4.59 |
30.54 |
3.13 |
4.29 |
11.06 |
3.47 |
3.05 |
18.46 |
7.50 |
|
5000 µg/plate |
Mean |
95 |
102 |
10 |
15 |
81 |
80 |
248 |
272 |
14 |
13 |
sd |
14.8 |
0.6 |
1.7 |
2.1 |
4.6 |
4.7 |
25.0 |
73.2 |
3.1 |
2.0 |
|
f(I) |
1.20 |
1.09 |
0.77 |
0.94 |
0.95 |
0.90 |
1.01 |
0.80 |
1.00 |
1.08 |
|
1500 µg/plate |
Mean |
94 |
85 |
12 |
13 |
76 |
75 |
304 |
264 |
11 |
12 |
sd |
9.3 |
9.6 |
1.5 |
4.0 |
7.2 |
6.1 |
38.2 |
45.1 |
1.5 |
1.0 |
|
f(I) |
1.19 |
0.90 |
0.92 |
0.81 |
0.89 |
0.84 |
1.24 |
0.77 |
0.79 |
1.00 |
|
500 µg/plate |
Mean |
75 |
108 |
13 |
15 |
88 |
86 |
233 |
257 |
13 |
15 |
sd |
13.0 |
22.2 |
4.7 |
1.2 |
6.7 |
0.6 |
28.1 |
45.4 |
2.1 |
3.0 |
|
f(I) |
0.95 |
1.15 |
1.00 |
0.94 |
1.04 |
0.97 |
0.95 |
0.75 |
0.93 |
1.25 |
|
150 µg/plate |
Mean |
102 |
91 |
16 |
14 |
82 |
80 |
272 |
224 |
18 |
11 |
sd |
10.6 |
4.5 |
1.5 |
3.1 |
6.7 |
6.4 |
40.6 |
17.4 |
2.3 |
1.2 |
|
f(I) |
1.29 |
0.97 |
1.23 |
0.88 |
0.96 |
0.90 |
1.11 |
0.66 |
1.29 |
0.92 |
|
50 µg/plate |
Mean |
87 |
107 |
14 |
12 |
84 |
86 |
380 |
344 |
12 |
12 |
sd |
11.9 |
20.8 |
3.2 |
4.0 |
9.0 |
0.6 |
69.7 |
18.3 |
3.8 |
1.2 |
|
f(I) |
1.10 |
1.14 |
1.08 |
0.75 |
0.99 |
0.97 |
1.55 |
1.01 |
0.86 |
1.00 |
Mean Revertants Second Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
63 |
84 |
13 |
18 |
75 |
93 |
236 |
280 |
14 |
12 |
sd |
6.2 |
11.2 |
0.6 |
3.1 |
2.1 |
3.5 |
14.4 |
21.2 |
4.5 |
3.2 |
|
DMSO |
Mean |
62 |
90 |
11 |
13 |
73 |
79 |
256 |
237 |
11 |
10 |
sd |
12.5 |
16.9 |
2.3 |
1.7 |
4.6 |
5.6 |
24.3 |
6.1 |
3.0 |
1.5 |
|
Positive |
Mean |
587 |
368 |
396 |
66 |
555 |
1523 |
2176 |
1485 |
284 |
82 |
sd |
237.4 |
39.4 |
86.8 |
7.0 |
92.7 |
69.0 |
180.1 |
166.5 |
83.2 |
20.4 |
|
f(I) |
9.47 |
4.09 |
36.00 |
5.08 |
7.40 |
19.28 |
8.50 |
6.27 |
20.29 |
8.20 |
|
5000 µg/plate |
Mean |
73 |
87 |
14 |
13 |
85 |
85 |
239 |
271 |
13 |
12 |
sd |
9.2 |
18.6 |
2.3 |
1.5 |
13.0 |
11.9 |
12.1 |
40.3 |
3.2 |
4.6 |
|
f(I) |
1.18 |
0.97 |
1.27 |
1.00 |
1.16 |
1.08 |
0.93 |
1.14 |
1.18 |
1.20 |
|
2500 µg/plate |
Mean |
60 |
81 |
8 |
14 |
74 |
78 |
252 |
296 |
14 |
13 |
sd |
15.5 |
10.6 |
1.2 |
2.5 |
8.7 |
8.7 |
21.2 |
52.3 |
2.5 |
3.2 |
|
f(I) |
0.97 |
0.90 |
0.73 |
1.08 |
1.01 |
0.99 |
0.98 |
1.25 |
1.27 |
1.30 |
|
1250 µg/plate |
Mean |
59 |
74 |
9 |
12 |
70 |
86 |
268 |
257 |
12 |
12 |
sd |
10.1 |
3.1 |
4.0 |
1.0 |
5.9 |
9.0 |
52.0 |
16.7 |
3.2 |
2.5 |
|
f(I) |
0.95 |
0.82 |
0.82 |
0.92 |
0.96 |
1.09 |
1.05 |
1.08 |
1.09 |
1.20 |
|
625 µg/plate |
Mean |
60 |
81 |
9 |
13 |
79 |
90 |
296 |
296 |
12 |
17 |
sd |
4.9 |
11.0 |
0.6 |
6.0 |
4.7 |
8.1 |
52.3 |
40.6 |
3.0 |
3.1 |
|
f(I) |
0.97 |
0.90 |
0.82 |
1.00 |
1.08 |
1.14 |
1.16 |
1.25 |
1.09 |
1.70 |
|
312 µg/plate |
Mean |
64 |
104 |
10 |
12 |
69 |
85 |
251 |
247 |
12 |
12 |
sd |
6.5 |
7.1 |
3.5 |
2.9 |
7.0 |
10.6 |
41.6 |
31.1 |
3.5 |
5.5 |
|
f(I) |
1.03 |
1.16 |
0.91 |
0.92 |
0.95 |
1.08 |
0.98 |
1.04 |
1.09 |
1.20 |
|
156 µg/plate |
Mean |
71 |
85 |
10 |
11 |
81 |
85 |
253 |
259 |
9 |
10 |
sd |
3.5 |
9.5 |
2.3 |
4.2 |
4.7 |
4.4 |
42.8 |
16.2 |
1.7 |
2.1 |
|
f(I) |
1.15 |
0.94 |
0.91 |
0.85 |
1.11 |
1.08 |
0.99 |
1.09 |
0.82 |
1.00 |
Applicant's summary and conclusion
- Conclusions:
- In all experiments, no precipitation of the test item was observed at any of the tested concentrations up to 5000 µg/plate. In the first and the second experiment, the test item caused no cytotoxicity towards all bacteria strains. The confirmation tests of the genotype did not show any irregularities. The control of the titre was above the demanded value of 109 bacteria/mL. All of the means of all replicates of the spontaneous revertants (in negative and solvent controls) were within the range of the historical data of the test facility. All numbers of re-vertant colonies of the positive controls were within the range of the historical data of the laboratory (historical data of the laboratory see chapter 15, page 40) and were increased in comparison with the negative controls, which demonstrated the mutagenic potential of the diagnostic mutagens. Since all criteria for acceptability have been met, the study is considered valid
- Executive summary:
Two valid experiments were performed. The study procedures described in this report were based on the most recent OECD and EC guidelines. The test item Bis[2-(diethylamino)ethyl]adipate was tested in the Salmonella typhimurium reverse mutation assay with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535). The test was performed in two experiments in the presence and absence of S9-mix (rat liver S9-mix induced by Aroclor 1254). In the first experiment, Bis[2-(diethylamino)ethyl]adipate (dissolved in DMSO) was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix (0.74 % final concentration in the treatment)in the strains TA97a, TA98, TA100, TA102 and TA1535 using the plate incorporation method. Bis[2-(diethylamino)ethyl]adipate showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item Bis[2-(diethylamino)ethyl]adipate showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. The results of this experiment showed that none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation. On the base of the first experiment, Bis[2-(diethylamino)ethyl]adipate was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix (0.74% final concentration in the treatment) in all bacteria strain using the pre-incubation method. Bis[2-(diethylamino)ethyl]adipate showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item Bis[2-(diethylamino)ethyl]adipate showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. The results of this experiments showed that the test item Bis[2-(diethylamino)ethyl]adipate caused no increase in the number of revertants in all bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test item Bis[2-(diethylamino)ethyl]adipate did not induce a dose-related increase in the number of revertants colonies in all strains, in the presence and absence of metabolic activation. Based on the results of this study it is concluded that Bis[2-(diethylamino)ethyl]adipate is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
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