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EC number: 247-667-6 | CAS number: 26402-22-2
- 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:
- 10 May - 07 Jun 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Esterification product of glycerol and C8-C12 (even numbered) fatty acids
- Molecular formula:
- not applicable, substance is UVCB
- IUPAC Name:
- Esterification product of glycerol and C8-C12 (even numbered) fatty acids
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Arochlor (1254 mg/kg bw)
- Test concentrations with justification for top dose:
- Exp 1a: 5000, 1500, 500, 150 and 50 µg/plate for all strains with and without metabolic activation
Exp 1b: 1500, 500, 150, 50 and 5 µg/plate for TA97a, TA98, TA100 and TA102 with and without metabolic activation
Exp 1b: 500, 150, 50, 15,5 and 1.5 µg/plate for TA1535
Exp 2a: 500, 250, 125, 62.5, 31.3, 15.6 and 7.8 µg/plate for TA97a, TA98, TA100 and TA102 with and without metabolic activation
Exp 2a: 150, 75, 37.5, 18.8, 9.4, 4.7 and 2.3 µg/plate for TA1535 with and without metabolic activation
Exp 2b: 500, 250, 125, 62.5, 31.3, 15.6 and 7.8 µg/plate for TA98 with and without metabolic activation - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle: DMSO was chosen as vehicle, because the test item was sufficiently soluble, and this solvent does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and deionised water
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: see "remarks"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation (Exp 1a and b); preincubation (Exp 2a and b)
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 3 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn - Evaluation criteria:
- 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.
- Statistics:
- Mean values and standard deviations were calculated.
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:
- cytotoxicity
- Remarks:
- Exp 1 and 2: at 500 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 97a, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp 1 and 2: at 1500 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test item showed no precipitates on the plates at any of the concentrations.
- Contamination: Due to the contamination of the bacteria strain TA98, a repetition of the experiment 2a for the bacteria strain TA98 (Exp 2b) was performed.
RANGE-FINDING/SCREENING STUDIES:
The toxicity of the test item at 5000 μg/plate was tested in a preliminary experiment at strains TA97a, TA98, TA100, TA102 and TA1535. Per strain, 2 plates with and without metabolic activation were incubated with the corresponding dose of the test item on maximal soft agar for 48 hours at 37 ±1°C. Toxicity was observed in all strains at 5000 µg/plate.
HISTORICAL CONTROL
All negative and all strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Any other information on results incl. tables
Table 1. Mean number of revertant colonies - Experiment 1a (plate incorporation method)
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
73 |
82 |
12 |
11 |
77 |
75 |
273 |
313 |
14 |
17 |
SD |
10.6 |
6.5 |
2.6 |
1.5 |
8.1 |
11.0 |
14.0 |
22.0 |
3.1 |
3.5 |
|
DMSO |
Mean |
80 |
90 |
9 |
11 |
80 |
85 |
276 |
256 |
22 |
19 |
SD |
15.0 |
13.1 |
1.2 |
1.5 |
5.5 |
25.6 |
17.4 |
10.6 |
2.1 |
4.0 |
|
Positive Controls* |
Mean |
337 |
404 |
496 |
74 |
284 |
361 |
719 |
769 |
309 |
113 |
SD |
41.1 |
77.9 |
39.4 |
14.0 |
16.0 |
18.5 |
18.0 |
103.9 |
59.0 |
23.2 |
|
f(I) |
4.21 |
4.49 |
55.11 |
6.73 |
3.69 |
4.25 |
2.61 |
3.00 |
22.07 |
5.95 |
|
5000 µg/plate |
Mean |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
40 |
0 |
0 |
SD |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
8.3 |
15.7 |
0.0 |
0.0 |
|
f(I) |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.11 |
0.16 |
0.00 |
0.00 |
|
1500 µg/plate |
Mean |
0 |
0 |
0 |
0 |
4 |
27 |
156 |
220 |
0 |
0 |
SD |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
11.8 |
12.5 |
55.0 |
0.0 |
0.0 |
|
f(I) |
0.00 |
0.00 |
0.00 |
0.00 |
0.05 |
0.32 |
0.57 |
0.86 |
0.00 |
0.00 |
|
500 µg/plate |
Mean |
77 |
79 |
10 |
9 |
73 |
71 |
309 |
255 |
4 |
9 |
SD |
9.5 |
21.9 |
0.0 |
1.0 |
9.2 |
8.2 |
37.2 |
38.4 |
2.9 |
2.9 |
|
f(I) |
0.96 |
0.88 |
1.11 |
0.82 |
0.91 |
0.84 |
1.12 |
1.00 |
0.18 |
0.47 |
|
150 µg/plate |
Mean |
79 |
76 |
12 |
9 |
84 |
75 |
240 |
281 |
19 |
26 |
SD |
5.1 |
6.1 |
1.0 |
4.0 |
6.1 |
13.2 |
45.1 |
42.8 |
4.0 |
3.8 |
|
f(I) |
0.99 |
0.84 |
1.33 |
0.82 |
1.05 |
0.88 |
0.87 |
1.10 |
0.86 |
1.37 |
|
50 µg/plate |
Mean |
101 |
75 |
13 |
17 |
79 |
73 |
257 |
299 |
24 |
27 |
SD |
13.4 |
5.5 |
4.0 |
2.5 |
5.2 |
15.9 |
30.3 |
31.1 |
2.6 |
6.0 |
|
f(I) |
1.26 |
0.83 |
1.44 |
1.55 |
0.99 |
0.86 |
0.93 |
1.17 |
1.09 |
1.42 |
f(l): increase factor (mean revertants divided by mean spontaneous revertants)
*Different positive controls were used, see “controls”
Table 2. Mean number of revertant colonies- Experiment 1b (plate incorporation method)
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
74 |
77 |
18 |
20 |
79 |
94 |
307 |
327 |
16 |
13 |
SD |
8.9 |
14.6 |
4.0 |
1.2 |
13.1 |
8.5 |
29.5 |
66.0 |
0.6 |
1.5 |
|
DMSO |
Mean |
75 |
71 |
25 |
23 |
71 |
80 |
288 |
328 |
14 |
14 |
SD |
7.8 |
10.1 |
4.5 |
4.7 |
7.1 |
8.4 |
41.8 |
72.8 |
2.1 |
2.0 |
|
Positive Controls* |
Mean |
322 |
454 |
224 |
195 |
481 |
412 |
2235 |
1355 |
216 |
143 |
SD |
36.7 |
154.2 |
36.0 |
12.2 |
9.2 |
14.4 |
68.0 |
382.5 |
25.1 |
43.9 |
|
f(I) |
4.29 |
6.39 |
8.96 |
8.48 |
6.09 |
5.15 |
7.76 |
4.13 |
13.50 |
10.21 |
|
1500 µg/plate |
Mean |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
n.d. |
n.d. |
SD |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
n.d. |
n.d. |
|
f(I) |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
n.d. |
n.d. |
|
500 µg/plate |
Mean |
96 |
65 |
19 |
23 |
70 |
73 |
206 |
237 |
0 |
0 |
SD |
12.9 |
6.0 |
2.0 |
3.5 |
3.6 |
19.1 |
51.0 |
72.6 |
0.0 |
0.0 |
|
f(I) |
1.28 |
0.92 |
0.76 |
1.00 |
0.99 |
0.91 |
0.72 |
0.72 |
0.00 |
0.00 |
|
150 µg/plate |
Mean |
71 |
88 |
23 |
21 |
69 |
75 |
297 |
358 |
14 |
11 |
SD |
10.8 |
14.6 |
1.5 |
1.2 |
17.2 |
4.0 |
30.0 |
83.2 |
3.8 |
3.2 |
|
f(I) |
0.95 |
1.24 |
0.92 |
0.91 |
0.97 |
0.94 |
1.03 |
1.09 |
1.00 |
0.79 |
|
50 µg/plate |
Mean |
92 |
91 |
22 |
22 |
78 |
68 |
341 |
341 |
15 |
12 |
SD |
15.6 |
21.5 |
1.0 |
2.1 |
19.9 |
6.1 |
98.8 |
32.1 |
3.5 |
4.0 |
|
f(I) |
1.23 |
1.28 |
0.88 |
0.96 |
1.10 |
0.85 |
1.18 |
1.04 |
1.07 |
0.86 |
|
15 µg/plate |
Mean |
79 |
103 |
22 |
22 |
68 |
74 |
231 |
229 |
14 |
12 |
SD |
7.6 |
10.5 |
4.0 |
5.6 |
7.6 |
9.5 |
66.6 |
34.0 |
3.1 |
3.5 |
|
f(I) |
1.05 |
1.45 |
0.88 |
0.96 |
0.96 |
0.93 |
0.80 |
0.70 |
1.00 |
0.86 |
|
5 µg/plate |
Mean |
74 |
101 |
23 |
23 |
83 |
79 |
284 |
296 |
14 |
16 |
SD |
17.1 |
15.4 |
3.2 |
2.5 |
6.7 |
12.5 |
42.1 |
52.9 |
3.2 |
0.6 |
|
f(I) |
0.99 |
1.42 |
0.92 |
1.00 |
1.17 |
0.99 |
0.99 |
0.90 |
1.00 |
1.14 |
|
1.5 µg/plate |
Mean |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
13 |
14 |
SD |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
1.0 |
2.5 |
|
f(I) |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
0.93 |
1.00 |
f(l): increase factor (mean revertants divided by mean spontaneous revertants)
*Different positive controls were used, see “controls”
n.d.: not determined
Table 3a. Mean number of revertant colonies - Experiment 2a (preincubation method)
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
|||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
79 |
105 |
n.e. |
n.e. |
76 |
87 |
349 |
325 |
SD |
14.2 |
10.8 |
n.e. |
n.e. |
10.7 |
3.5 |
18.9 |
40.1 |
|
DMSO |
Mean |
83 |
114 |
n.e. |
n.e. |
80 |
75 |
340 |
340 |
SD |
16.9 |
5.5 |
n.e. |
n.e. |
4.0 |
5.3 |
46.1 |
18.3 |
|
Positive Controls* |
Mean |
489 |
379 |
n.e. |
n.e. |
312 |
755 |
1084 |
1135 |
SD |
25.8 |
88.1 |
n.e. |
n.e. |
36.7 |
116.6 |
17.4 |
68.9 |
|
f(I) |
5.89 |
3.32 |
n.e. |
n.e. |
4.11 |
10.07 |
3.19 |
3.34 |
|
500 µg/plate |
Mean |
0 |
51 |
n.e. |
n.e. |
0 |
43 |
267 |
333 |
SD |
0.0 |
8.5 |
n.e. |
n.e. |
0.0 |
11.1 |
19.7 |
8.3 |
|
f(I) |
0.00 |
0.45 |
n.e. |
n.e. |
0.00 |
0.57 |
0.79 |
0.98 |
|
250 µg/plate |
Mean |
73 |
82 |
n.e. |
n.e. |
26 |
79 |
281 |
281 |
SD |
7.5 |
14.6 |
n.e. |
n.e. |
8.5 |
9.0 |
31.1 |
18.0 |
|
f(I) |
0.88 |
0.72 |
n.e. |
n.e. |
0.33 |
1.05 |
0.83 |
0.83 |
|
125 µg/plate |
Mean |
71 |
101 |
n.e. |
n.e. |
67 |
72 |
271 |
300 |
SD |
5.9 |
9.1 |
n.e. |
n.e. |
5.6 |
1.5 |
26.6 |
38.2 |
|
f(I) |
0.86 |
0.89 |
n.e. |
n.e. |
0.84 |
0.96 |
0.80 |
0.88 |
|
62.5 µg/plate |
Mean |
75 |
87 |
n.e. |
n.e. |
74 |
75 |
279 |
299 |
SD |
6.0 |
16.7 |
n.e. |
n.e. |
6.6 |
7.6 |
14.0 |
4.6 |
|
f(I) |
0.90 |
0.76 |
n.e. |
n.e. |
0.93 |
1.00 |
0.82 |
0.88 |
|
31.3 µg/plate |
Mean |
72 |
84 |
n.e. |
n.e. |
81 |
79 |
337 |
313 |
SD |
4.7 |
12.2 |
n.e. |
n.e. |
7.9 |
5.5 |
25.7 |
33.3 |
|
f(I) |
0.87 |
0.74 |
n.e. |
n.e. |
1.01 |
1.05 |
0.99 |
0.92 |
|
15.6 µg/plate |
Mean |
72 |
77 |
n.e. |
n.e. |
72 |
80 |
309 |
305 |
SD |
9.5 |
14.0 |
n.e. |
n.e. |
7.5 |
13.6 |
12.2 |
19.7 |
|
f(I) |
0.87 |
0.68 |
n.e. |
n.e. |
0.90 |
1.07 |
0.91 |
0.90 |
|
7.8 µg/plate |
Mean |
75 |
75 |
n.e. |
n.e. |
80 |
74 |
265 |
353 |
SD |
5.5 |
9.5 |
n.e. |
n.e. |
2.6 |
5.0 |
20.1 |
64.8 |
|
f(I) |
0.90 |
0.66 |
n.e. |
n.e. |
1.00 |
0.99 |
0.78 |
1.04 |
n.e.: not evaluated, due to contamination
f(l): increase factor (mean revertants divided by mean spontaneous revertants)
*Different positive controls were used, see “controls”
Table 3b. Mean number of revertant colonies of TA1535 - Experiment 2a (preincubation method)
Strain |
TA1535 |
||
Induction |
-S9 |
+S9 |
|
Demin. water |
Mean |
22 |
18 |
SD |
3.2 |
2.6 |
|
DMSO |
Mean |
20 |
21 |
SD |
4.0 |
2.0 |
|
Positive Controls* |
Mean |
277 |
77 |
SD |
48.9 |
8.6 |
|
f(I) |
12.59 |
3.67 |
|
150 µg/plate |
Mean |
13 |
21 |
SD |
1.5 |
3.5 |
|
f(I) |
0.65 |
1.00 |
|
75 µg/plate |
Mean |
20 |
24 |
SD |
7.2 |
4.9 |
|
f(I) |
1.00 |
1.14 |
|
37.5 µg/plate |
Mean |
19 |
21 |
SD |
4.7 |
4.0 |
|
f(I) |
0.95 |
1.00 |
|
18.8 µg/plate |
Mean |
20 |
21 |
SD |
3.6 |
2.1 |
|
f(I) |
1.00 |
1.00 |
|
9.4 µg/plate |
Mean |
21 |
18 |
SD |
2.5 |
2.5 |
|
f(I) |
1.05 |
0.86 |
|
4.7 µg/plate |
Mean |
20 |
20 |
SD |
3.8 |
5.1 |
|
f(I) |
1.00 |
0.95 |
|
2.3 µg/plate |
Mean |
18 |
19 |
SD |
4.5 |
3.8 |
|
f(I) |
0.90 |
0.90 |
f(l): increase factor (mean revertants divided by mean spontaneous revertants)
*Different positive controls were used, see “controls”
Table 4. Mean number of revertant colonies of TA98 - Experiment 2b (preincubation method)
Strain |
TA98 |
||
Induction |
-S9 |
+S9 |
|
Demin. water |
Mean |
17 |
17 |
SD |
1.0 |
1.0 |
|
DMSO |
Mean |
16 |
14 |
SD |
2.6 |
0.0 |
|
Positive Controls* |
Mean |
331 |
106 |
SD |
34.0 |
14.6 |
|
f(I) |
19.47 |
7.57 |
|
500 µg/plate |
Mean |
0 |
0 |
SD |
0.0 |
0.0 |
|
f(I) |
0.00 |
0.00 |
|
250 µg/plate |
Mean |
2 |
3 |
SD |
1.2 |
0.0 |
|
f(I) |
0.11 |
0.18 |
|
125 µg/plate |
Mean |
12 |
13 |
SD |
2.6 |
1.5 |
|
f(I) |
0.63 |
0.76 |
|
62.5 µg/plate |
Mean |
14 |
11 |
SD |
0.0 |
2.0 |
|
f(I) |
0.74 |
0.65 |
|
31.3 µg/plate |
Mean |
13 |
11 |
SD |
1.5 |
0.6 |
|
f(I) |
0.68 |
0.65 |
|
15.6 µg/plate |
Mean |
13 |
13 |
SD |
0.6 |
0.6 |
|
f(I) |
0.68 |
0.76 |
|
7.8 µg/plate |
Mean |
15 |
15 |
SD |
1.0 |
4.0 |
|
f(I) |
0.79 |
0.88 |
f(l): increase factor (mean revertants divided by mean spontaneous revertants)
*Different positive controls were used, see “controls”
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five strains (TA97a, TA98, TA100, TA102 and TA1535) tested with and without metabolic activation.
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