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EC number: 247-667-6 | CAS number: 26402-22-2
- Life Cycle description
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- Endpoint summary
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- 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
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- Toxicological Summary
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test (OECD 471): negative with S. typhimurium TA97a, TA98, TA100, TA102 and TA1535 with and without metabolic activation
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:
- 10 May - 07 Jun 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)
- 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
- Target gene:
- his operon
- 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. - 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.
- 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. - 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.
Reference
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”
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A bacterial gene mutation assay with the test substance Esterification product of glycerol and C8-C12 (even numbered) fatty acids was performed in accordance with OECD Guideline 471 and in compliance with GLP (Key, 2017). In three independent experiments, the Salmonella typhimurium strains TA97a, TA98, TA 100, TA 102 and TA 1535 were exposed to the test substance using the pre-incubation method (Exp 1a and b) and standard plate incorporation method (Exp 2a and b). In experiment 1a all strains were tested at concentrations of 50 - 5000 µg/plate with and without metabolic activation. In Experiment 1b strains TA97a, TA98, TA100 and TA102 were tested at concentrations of 5 – 1500 µg/plate and strain TA1535 at 1.5 – 500 µg/plate with and without metabolic activation. In Experiment 2a strains TA97a, TA98, TA100 and TA102 were tested at concentrations of 7.8 – 500 µg/plate and for strain 1535 at 2.3 – 150 µg/plate with and without metabolic activation. Since contamination occurred within strain TA98 of Exp 2a, this experiment was repeated with strain TA98 only under same conditions and was reported as Experiment 2b. No substantial increase in the mean number of revertants per plate was observed in any of the test strains compared to the control, neither in the presence nor in the absence of metabolic activation. The test substance was bacteriotoxic at 500 µg/plate and above towards strain TA1535 and at 1500 µg/plate and above towards strains TA 97a, TA98, TA 100, and TA102. The test item showed no precipitates on the plates at any of the concentrations. All positive and negative control values were found to be within the respective historical control ranges. Under the conditions of this experiment, the test substance did not show mutagenicity in the selected S. typhimurium strains in the presence and absence of metabolic activation.
Justification for classification or non-classification
The available data on genetic toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008.
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