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EC number: 815-096-7 | CAS number: 1421927-53-8
- 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
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- 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 results of the Bacterial Reverse Mutation Test it is concluded that EDA-DOPO is not mutagenic in the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the pre-sent study.
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:
- 2016-09-23 - 2016-10-07
- 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
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- DMSO was chosen as vehicle because the best result of a homogeneous and pipettable suspension was achieved with the solvent DMSO. ; tThis solvent does not have any ef-fects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
The following nominal concentrations were prepared for the first experiment:
5000 µg/plate, 1500 µg/plate, 500 µg/plate, 150 µg/plate and 50 µg/plate.
The following nominal concentrations were prepared for the second experiment:
5000 µg/plate, 2500 µg/plate, 1250 µg/plate, 625 µg/plate, 313 µg/plate and 156 µg/plate. - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine, 2-Amino-Anthracene
- Evaluation criteria:
- 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 re-vertant 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. - 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 97
- 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 102
- 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
- Conclusions:
- Based on the results of this study it is concluded that EDA-DOPO is not mutagenic in the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the ab-sence and presence of metabolic activation under the experimental conditions in the pre-sent study.
- 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 EDA-DOPO was tested in theSalmonella typhimuriumreverse mutation assay with five strains ofSalmonella typhimurium(TA97a, TA98, TA100, TA102 and TA1535). The test was performed in triplicates in the presence and absence of S9-mix (rat liver S9-mix induced by Aroclor 1254).
In the first experiment, EDA-DOPO (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.
EDA-DOPOshowed 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 EDA-DOPO 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, EDA-DOPO 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.
EDA-DOPOshowed 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 EDA-DOPO 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 EDA-DOPO 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 EDA-DOPO 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 EDA-DOPO is not mutagenic in theSalmonella typhimuriumstrains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
Reference
First Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
87 |
88 |
19 |
19 |
106 |
113 |
387 |
383 |
24 |
23 |
sd |
21.1 |
20.4 |
3.6 |
2.1 |
18.0 |
18.5 |
76.6 |
18.0 |
1.0 |
5.6 |
|
DMSO |
Mean |
73 |
105 |
12 |
17 |
105 |
110 |
356 |
357 |
26 |
24 |
sd |
1.5 |
39.0 |
1.0 |
4.0 |
15.3 |
9.2 |
6.9 |
40.3 |
3.5 |
6.4 |
|
Positive |
Mean |
351 |
388 |
296 |
61 |
647 |
1176 |
760 |
1088 |
365 |
145 |
sd |
175.5 |
90.6 |
69.3 |
9.8 |
16.2 |
259.6 |
28.8 |
350.9 |
96.0 |
23.7 |
|
f(I) |
4.81 |
3.70 |
24.67 |
3.59 |
6.10 |
10.69 |
2.13 |
3.05 |
15.21 |
6.04 |
|
5000 µg/plate |
Mean |
104 |
90 |
14 |
12 |
116 |
112 |
291 |
251 |
27 |
28 |
sd |
11.1 |
25.7 |
3.2 |
1.5 |
5.3 |
17.1 |
28.4 |
37.2 |
4.0 |
8.9 |
|
f(I) |
1.42 |
0.86 |
1.17 |
0.71 |
1.10 |
1.02 |
0.82 |
0.70 |
1.04 |
1.17 |
|
1500 µg/plate |
Mean |
86 |
95 |
16 |
13 |
108 |
108 |
231 |
273 |
25 |
26 |
sd |
23.1 |
23.0 |
1.5 |
2.6 |
15.5 |
16.7 |
34.9 |
102.2 |
5.2 |
6.5 |
|
f(I) |
1.18 |
0.90 |
1.33 |
0.76 |
1.03 |
0.98 |
0.65 |
0.76 |
0.96 |
1.08 |
|
500 µg/plate |
Mean |
111 |
104 |
16 |
15 |
110 |
113 |
336 |
331 |
24 |
37 |
sd |
7.0 |
30.8 |
2.6 |
2.1 |
16.2 |
11.1 |
38.2 |
67.2 |
7.4 |
7.5 |
|
f(I) |
1.52 |
0.99 |
1.33 |
0.88 |
1.05 |
1.03 |
0.94 |
0.93 |
0.92 |
1.54 |
|
150 µg/plate |
Mean |
104 |
108 |
12 |
12 |
105 |
115 |
279 |
235 |
23 |
27 |
sd |
22.1 |
18.0 |
1.0 |
1.0 |
14.8 |
6.4 |
48.4 |
63.8 |
5.5 |
3.6 |
|
f(I) |
1.42 |
1.03 |
1.00 |
0.71 |
1.00 |
1.05 |
0.78 |
0.66 |
0.88 |
1.13 |
|
50 µg/plate |
Mean |
91 |
87 |
13 |
13 |
92 |
119 |
335 |
259 |
26 |
22 |
sd |
18.0 |
18.1 |
2.6 |
1.0 |
15.9 |
3.1 |
6.1 |
22.0 |
4.0 |
4.5 |
|
f(I) |
1.25 |
0.83 |
1.08 |
0.76 |
0.88 |
1.08 |
0.94 |
0.73 |
1.00 |
0.92 |
Second Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
108 |
91 |
9 |
14 |
100 |
96 |
264 |
331 |
19 |
12 |
sd |
7.0 |
8.7 |
1.5 |
4.0 |
2.0 |
9.2 |
13.9 |
22.0 |
2.9 |
1.5 |
|
DMSO |
Mean |
91 |
89 |
13 |
10 |
89 |
98 |
257 |
309 |
13 |
14 |
sd |
14.4 |
4.9 |
3.0 |
1.2 |
6.0 |
12.5 |
6.1 |
37.8 |
1.2 |
2.1 |
|
Positive |
Mean |
665 |
448 |
372 |
79 |
444 |
480 |
769 |
1525 |
291 |
64 |
sd |
40.5 |
150.3 |
44.0 |
6.2 |
40.6 |
48.0 |
10.1 |
113.5 |
74.4 |
14.0 |
|
f(I) |
7.31 |
5.03 |
28.62 |
7.90 |
4.44 |
4.90 |
2.99 |
4.94 |
15.32 |
4.57 |
|
5000 µg/plate |
Mean |
79 |
99 |
16 |
15 |
66 |
78 |
375 |
393 |
14 |
17 |
sd |
6.4 |
15.3 |
1.0 |
4.4 |
8.7 |
10.4 |
30.6 |
93.8 |
3.2 |
4.2 |
|
f(I) |
0.87 |
1.11 |
1.23 |
1.50 |
0.74 |
0.80 |
1.46 |
1.27 |
1.08 |
1.21 |
|
2500 µg/plate |
Mean |
96 |
108 |
12 |
14 |
75 |
88 |
311 |
377 |
13 |
15 |
sd |
20.0 |
2.6 |
4.4 |
3.5 |
10.2 |
9.6 |
91.4 |
26.6 |
2.3 |
2.9 |
|
f(I) |
1.05 |
1.21 |
0.92 |
1.40 |
0.84 |
0.90 |
1.21 |
1.22 |
1.00 |
1.07 |
|
1250 µg/plate |
Mean |
90 |
101 |
11 |
13 |
79 |
84 |
377 |
372 |
12 |
15 |
sd |
23.6 |
16.5 |
2.0 |
1.5 |
4.4 |
4.2 |
36.3 |
50.0 |
2.1 |
3.6 |
|
f(I) |
0.99 |
1.13 |
0.85 |
1.30 |
0.89 |
0.86 |
1.47 |
1.20 |
0.92 |
1.07 |
|
625 µg/plate |
Mean |
95 |
91 |
11 |
14 |
70 |
81 |
393 |
445 |
9 |
16 |
sd |
10.6 |
22.2 |
1.5 |
4.6 |
0.6 |
15.3 |
76.4 |
64.7 |
0.6 |
3.5 |
|
f(I) |
1.04 |
1.02 |
0.85 |
1.40 |
0.79 |
0.83 |
1.53 |
1.44 |
0.69 |
1.14 |
|
312 µg/plate |
Mean |
81 |
109 |
13 |
15 |
86 |
88 |
299 |
341 |
15 |
15 |
sd |
9.1 |
12.1 |
2.5 |
3.5 |
21.2 |
7.0 |
39.5 |
40.1 |
2.1 |
3.5 |
|
f(I) |
0.89 |
1.22 |
1.00 |
1.50 |
0.97 |
0.90 |
1.16 |
1.10 |
1.15 |
1.07 |
|
156 µg/plate |
Mean |
90 |
122 |
15 |
18 |
71 |
88 |
309 |
305 |
11 |
16 |
sd |
3.6 |
6.0 |
2.0 |
1.7 |
5.5 |
9.6 |
20.5 |
14.0 |
1.2 |
2.6 |
|
f(I) |
0.99 |
1.37 |
1.15 |
1.80 |
0.80 |
0.90 |
1.20 |
0.99 |
0.85 |
1.14 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results of the bacterial reverse mutation assay EDA-DOPO has not to be classified for mutagenicity.
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