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EC number: 254-104-8 | CAS number: 38725-13-2
- 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
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- Endpoint summary
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- 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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- 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 19 December 2017 to 18 July 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Triisononylamine
- EC Number:
- 254-104-8
- EC Name:
- Triisononylamine
- Cas Number:
- 38725-13-2
- Molecular formula:
- C27H57N
- IUPAC Name:
- tris(7-methyloctyl)amine
- 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: supplied by the sponsor, batch 99671
- Expiration date of the lot/batch: 9 October 2019
- Purity test date: 6 November 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: the test item was stored in the test facility in a closed vessel at room temperature (20±5°C)
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: the test item was completely soluble in acetone, only
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No reactivity
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: a stock solution containing 50 mL/L of the test item in acetone was prepared. Nominal concentrations were prepared
- Preliminary purification step (if any): not applicable
- Final dilution of a dissolved solid, stock liquid or gel: 50 mL/L
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material)
In solution with acetone
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: S. Typhimurium TA97a, TA98, TA100, TA102 and TA1535
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- other: See tables in "any other information on material and methods including tables" section
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 was obtained produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intra-peritoneally.
- Test concentrations with justification for top dose:
- On the day of the start of the experiment 1a, a stock solution containing 50 mL/L of the test item in acetone was prepared. The following nominal concentrations were prepared for the first experiment: 5 µL/plate, 1.5 µL/plate, 0.5 µL/plate, 0.15 µL/plate and 0.05 µL/plate.
The following nominal concentrations were prepared for the experiment 1b for the bacteria strains TA97a, TA98, TA100 and TA102: 5 µL/plate, 1.5 µL/plate, 0.5 µL/plate, 0.15 µL/plate, 0.05 µL/plate and 0.015 µL/plate.
The following nominal concentrations were prepared for the experiment 1b for the bacteria strain TA1535: 1.5 µL/plate, 0.5 µL/plate, 0.15 µL/plate, 0.05 µL/plate, 0.015 µL and 0.005 µL/plate.
The following nominal concentrations were prepared for the experiment 1b for the bacteria strains TA97a, TA98, TA100 and TA102: 5 µL/plate, 2.5 µL/plate, 1.25 µL/plate, 0.63 µL/plate, 0.31 µL/plate, 0.16 µL/plate, 0.08 µL/plate and 0.04 µL/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle:In a non-GLP pre-test, the solubility of the test item was tested in a concentration of 50 mL/L in demineralized water, dimethyl sulfoxide (DMSO) and acetone.
The test item was completely soluble in acetone, only.
Acetone 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 sponta-neous revertants in the tested concentrations.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-nitro-1,2-phenylene Diamine ; 2-Amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Cell density at seeding (if applicable): 10E9 bacteria/mL
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 after treatment
NUMBER OF REPLICATIONS: three replicates were used per condition
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: The colonies were counted visually and the numbers were recorded.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: bacterial background lawn - Evaluation criteria:
- 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. An increase factor of 3 should be taken into account for the bacteria strain TA1535. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
- 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.
Results and discussion
Test results
- Key result
- Species / strain:
- bacteria, other: S. Typhimurium TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Experiment 1a:
All strains met the criterion of at least 109 bacteria/mL, and no inconsistencies were found in the sterility control. Nearly all determined values for the spontaneous revertants (one exception) of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic muta-gens) showed mutagenic effects with and without metabolic activation and were within the historical control data ranges.
In the first experiment, the test item showed no precipitates on the plates in all tested concentrations. In the highest concentration (5 µL/plate), no bacteria growth and no bacterial background lawn was observed. Towards the bacteria strain TA1535, signs of toxicity (decrease in the number of revertants) were observed in the next lower concentration (1.5 µL/plate), too. No increase of the number of revertant colonies in the treatments with and without meta-bolic activation could be observed. No concentration-related increase over the tested range was found.
Experiment 1b
All strains met the criterion of at least 109 bacteria/mL, and no inconsistencies were found in the sterility control. Nearly all determined values for the spontaneous revertants of the negative controls (one exception in the negative control acetone) were in the normal range of the test laboratory. All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and were within the historical control data ranges. In this experiment, the test item showed no precipitates on the plates in all tested concentrations. In the highest concentration (5 µL/plate), no bacteria growth and no bacterial background lawn was observed. Towards the bacteria strain TA1535, signs of toxicity (decrease in the number of revertants) were observed in the next lower concentration (1.5 µL/plate), too. No increase of the number of revertant colonies in the treatments with and without meta-bolic activation could be observed. No concentration-related increase over the tested range was found.
Experiment 2:
All strains met the criterion of at least 109 bacteria/mL, and no inconsistencies were found in the sterility control. Nearly all determined values for the spontaneous revertants of the negative controls (one exception in the negative control acetone) were in the normal range of the test laboratory. All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and were within the historical control data ranges. In this experiment, the test item showed no precipitates on the plates in all tested concentrations. Signs of toxicity were observed in the following concentrations with and without metabolic activation towards the resp. bacteria strains:
TA97a: no toxicity was observed
TA98: 5 µL/plate (decrease in the number of revertants)
TA100: 5 and 2.5 µL/plate (decrease in the number of revertants)
TA102: no toxicity was observed
TA1535: 1.5 µL/plate (decrease in the number of revertants)
The bacterial background lawn was visible in all concentrations.
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Historical data were presented in table in any other information on results including tables section.
Any other information on results incl. tables
Table2 Mean Revertants Experiment 1a
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
73 |
84 |
36 |
33 |
92 |
108 |
249 |
259 |
21 |
22 |
sd |
7.6 |
5.1 |
6.2 |
5.5 |
8.0 |
15.9 |
26.6 |
53.3 |
1.2 |
1.5 |
|
DMSO |
Mean |
74 |
110 |
38 |
36 |
89 |
91 |
239 |
249 |
26 |
18 |
sd |
5.2 |
21.1 |
4.4 |
11.9 |
9.2 |
1.2 |
28.9 |
46.0 |
1.7 |
0.6 |
|
Acetone |
Mean |
74 |
109 |
36 |
35 |
99 |
99 |
288 |
272 |
25 |
23 |
sd |
6.4 |
15.5 |
2.1 |
4.5 |
27.2 |
2.3 |
38.2 |
24.0 |
5.8 |
2.0 |
|
Positive |
Mean |
479 |
463 |
268 |
176 |
379 |
1001 |
657 |
1323 |
220 |
175 |
sd |
67.2 |
132.3 |
28.0 |
24.3 |
62.3 |
0.0 |
9.2 |
60.0 |
10.6 |
31.1 |
|
f(I) |
6.47 |
4.21 |
7.05 |
4.89 |
4.12 |
11.00 |
2.75 |
5.31 |
10.48 |
9.72 |
|
5 µL/plate |
Mean |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
sd |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
f(I) |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
1.5 µL/plate |
Mean |
72 |
83 |
26 |
36 |
80 |
95 |
201 |
217 |
11 |
14 |
sd |
8.6 |
1.2 |
6.0 |
6.9 |
9.8 |
11.7 |
55.2 |
60.7 |
1.7 |
3.5 |
|
f(I) |
0.97 |
0.76 |
0.72 |
1.03 |
0.81 |
0.96 |
0.70 |
0.80 |
0.44 |
0.61 |
|
0.5 µL/plate |
Mean |
85 |
95 |
32 |
33 |
83 |
104 |
251 |
252 |
18 |
16 |
sd |
4.6 |
13.3 |
4.7 |
7.4 |
15.1 |
20.0 |
19.7 |
93.0 |
4.0 |
7.2 |
|
f(I) |
1.15 |
0.87 |
0.89 |
0.94 |
0.84 |
1.05 |
0.87 |
0.93 |
0.72 |
0.70 |
|
0.15 µL/plate |
Mean |
78 |
86 |
36 |
35 |
95 |
95 |
224 |
243 |
13 |
17 |
sd |
10.4 |
27.1 |
6.4 |
9.6 |
1.2 |
7.0 |
48.0 |
39.3 |
2.6 |
3.2 |
|
f(I) |
1.05 |
0.79 |
1.00 |
1.00 |
0.96 |
0.96 |
0.78 |
0.89 |
0.52 |
0.74 |
|
0.05 µL/plate |
Mean |
79 |
74 |
35 |
35 |
92 |
97 |
203 |
188 |
25 |
24 |
sd |
15.1 |
9.2 |
1.2 |
1.5 |
9.2 |
24.3 |
12.9 |
25.0 |
5.3 |
5.6 |
|
f(I) |
1.07 |
0.68 |
0.97 |
1.00 |
0.93 |
0.98 |
0.70 |
0.69 |
1.00 |
1.04 |
1001 colonies per plate means the bacteria growth was too strong for counting.
f(I) = increase factor
Table3Mean Revertants Experiment 1b
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
77 |
86 |
35 |
34 |
86 |
80 |
335 |
329 |
29 |
25 |
sd |
14.8 |
18.9 |
3.2 |
6.1 |
12.0 |
15.4 |
30.0 |
20.1 |
5.0 |
4.0 |
|
DMSO |
Mean |
79 |
71 |
34 |
38 |
75 |
87 |
328 |
283 |
21 |
19 |
sd |
15.6 |
9.5 |
2.6 |
6.5 |
14.2 |
20.7 |
36.0 |
35.9 |
2.6 |
5.9 |
|
Acetone |
Mean |
73 |
77 |
36 |
41 |
81 |
112 |
325 |
300 |
24 |
24 |
sd |
5.8 |
2.6 |
5.6 |
5.9 |
7.6 |
14.2 |
15.1 |
58.9 |
6.9 |
4.0 |
|
Positive |
Mean |
584 |
669 |
443 |
451 |
547 |
1001 |
1371 |
1533 |
343 |
243 |
sd |
65.5 |
6.1 |
72.6 |
68.0 |
196.3 |
0.0 |
59.0 |
53.3 |
44.1 |
11.5 |
|
f(I) |
7.39 |
9.42 |
13.03 |
11.87 |
6.36 |
11.51 |
4.18 |
5.42 |
11.83 |
12.79 |
|
5 µL/plate |
Mean |
72 |
89 |
8 |
11 |
20 |
36 |
41 |
43 |
n.d. |
n.d. |
sd |
12.0 |
11.8 |
1.0 |
1.0 |
6.1 |
20.8 |
0.6 |
8.7 |
n.d. |
n.d. |
|
f(I) |
0.99 |
1.16 |
0.22 |
0.27 |
0.25 |
0.32 |
0.13 |
0.14 |
n.d. |
n.d. |
|
1.5 µL/plate |
Mean |
84 |
101 |
34 |
34 |
79 |
106 |
320 |
293 |
7 |
4 |
sd |
4.0 |
14.5 |
7.6 |
6.4 |
3.6 |
18.6 |
52.5 |
134.5 |
0.6 |
2.3 |
|
f(I) |
1.15 |
1.31 |
0.94 |
0.83 |
0.98 |
0.95 |
0.98 |
0.98 |
0.29 |
0.17 |
|
0.5 µL/plate |
Mean |
88 |
119 |
34 |
35 |
82 |
88 |
231 |
340 |
30 |
30 |
sd |
8.0 |
4.2 |
4.4 |
4.5 |
10.1 |
16.5 |
56.6 |
66.1 |
9.2 |
6.7 |
|
f(I) |
1.21 |
1.55 |
0.94 |
0.85 |
1.01 |
0.79 |
0.71 |
1.13 |
1.25 |
1.25 |
|
0.15 µL/plate |
Mean |
94 |
97 |
33 |
39 |
82 |
105 |
311 |
328 |
29 |
31 |
sd |
1.7 |
6.4 |
7.0 |
10.4 |
12.8 |
6.4 |
112.0 |
0.0 |
9.1 |
7.0 |
|
f(I) |
1.29 |
1.26 |
0.92 |
0.95 |
1.01 |
0.94 |
0.96 |
1.09 |
1.21 |
1.29 |
|
0.05 µL/plate |
Mean |
70 |
89 |
43 |
38 |
111 |
112 |
293 |
395 |
35 |
28 |
sd |
12.1 |
18.6 |
1.5 |
6.4 |
13.0 |
14.2 |
48.9 |
51.4 |
4.6 |
7.5 |
|
f(I) |
0.96 |
1.16 |
1.19 |
0.93 |
1.37 |
1.00 |
0.90 |
1.32 |
1.46 |
1.17 |
|
0.015 µL/plate |
Mean |
78 |
76 |
36 |
36 |
97 |
100 |
384 |
403 |
26 |
31 |
sd |
8.7 |
8.7 |
1.7 |
5.0 |
15.1 |
18.3 |
52.5 |
41.1 |
3.0 |
6.1 |
|
f(I) |
1.07 |
0.99 |
1.00 |
0.88 |
1.20 |
0.89 |
1.18 |
1.34 |
1.08 |
1.29 |
|
0.005 µL/plate |
Mean |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
32 |
34 |
sd |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
6.7 |
6.4 |
|
f(I) |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
1.33 |
1.42 |
1001 colonies per plate means the bacteria growth was too strong for counting.
n.d. = not determined, due to the toxicity effect in experiment 1a
f(I) = increase factor
Table4 Mean Revertants Experiment 2
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
|||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
80 |
75 |
34 |
45 |
101 |
117 |
317 |
325 |
sd |
14.0 |
8.3 |
4.0 |
2.1 |
14.2 |
2.3 |
22.7 |
18.0 |
|
DMSO |
Mean |
71 |
81 |
41 |
42 |
87 |
92 |
304 |
300 |
sd |
9.0 |
1.2 |
7.5 |
3.8 |
5.9 |
10.4 |
38.2 |
41.6 |
|
Acetone |
Mean |
86 |
79 |
39 |
42 |
84 |
120 |
331 |
291 |
sd |
13.5 |
12.5 |
5.3 |
3.6 |
3.5 |
5.3 |
10.1 |
36.3 |
|
Positive |
Mean |
268 |
368 |
307 |
328 |
372 |
1001 |
663 |
1267 |
sd |
50.1 |
26.2 |
59.9 |
52.9 |
32.7 |
0.0 |
52.8 |
125.6 |
|
f(I) |
3.77 |
4.54 |
7.49 |
7.81 |
3.68 |
10.88 |
2.18 |
4.22 |
|
5 µL/plate |
Mean |
72 |
93 |
15 |
12 |
12 |
26 |
296 |
343 |
sd |
19.1 |
25.4 |
1.2 |
5.2 |
1.0 |
9.9 |
55.0 |
20.1 |
|
f(I) |
0.84 |
1.18 |
0.38 |
0.29 |
0.14 |
0.22 |
0.89 |
1.18 |
|
2.5 µL/plate |
Mean |
78 |
89 |
37 |
24 |
38 |
45 |
267 |
256 |
sd |
12.5 |
5.3 |
7.5 |
5.6 |
13.5 |
13.1 |
82.6 |
24.3 |
|
f(I) |
0.91 |
1.13 |
0.95 |
0.57 |
0.45 |
0.38 |
0.81 |
0.88 |
|
1.25 µL/plate |
Mean |
77 |
74 |
37 |
29 |
74 |
76 |
333 |
369 |
sd |
4.7 |
7.5 |
5.2 |
10.0 |
10.5 |
6.4 |
24.1 |
100.4 |
|
f(I) |
0.90 |
0.94 |
0.95 |
0.69 |
0.88 |
0.63 |
1.01 |
1.27 |
|
0.63 µL/plate |
Mean |
69 |
77 |
36 |
34 |
75 |
104 |
316 |
329 |
sd |
14.2 |
3.1 |
4.2 |
3.0 |
4.5 |
8.5 |
50.0 |
56.6 |
|
f(I) |
0.80 |
0.97 |
0.92 |
0.81 |
0.89 |
0.87 |
0.95 |
1.13 |
|
0.31 µL/plate |
Mean |
100 |
77 |
34 |
38 |
86 |
96 |
320 |
376 |
sd |
10.1 |
9.6 |
8.4 |
3.5 |
8.7 |
15.0 |
48.5 |
17.4 |
|
f(I) |
1.16 |
0.97 |
0.87 |
0.90 |
1.02 |
0.80 |
0.97 |
1.29 |
|
0.16 µL/plate |
Mean |
82 |
72 |
35 |
33 |
111 |
110 |
352 |
388 |
sd |
1.5 |
3.2 |
14.0 |
3.8 |
12.7 |
11.7 |
24.3 |
82.7 |
|
f(I) |
0.95 |
0.91 |
0.90 |
0.79 |
1.32 |
0.92 |
1.06 |
1.33 |
|
0.08 µL/plate |
Mean |
86 |
91 |
37 |
34 |
108 |
105 |
397 |
421 |
sd |
18.0 |
4.0 |
2.5 |
1.7 |
8.9 |
18.0 |
73.4 |
26.6 |
|
f(I) |
1.00 |
1.15 |
0.95 |
0.81 |
1.29 |
0.88 |
1.20 |
1.45 |
|
0.04 µL/plate |
Mean |
80 |
81 |
42 |
36 |
93 |
89 |
297 |
389 |
sd |
2.0 |
1.0 |
12.5 |
2.6 |
16.8 |
8.7 |
75.6 |
68.6 |
|
f(I) |
0.93 |
1.03 |
1.08 |
0.86 |
1.11 |
0.74 |
0.90 |
1.34 |
1001 colonies per plate means the bacteria growth was too strong for counting.
f(I) = increase factor
Strain |
TA1535 |
||
Induction |
-S9 |
+S9 |
|
Demin. water |
Mean |
14 |
12 |
sd |
5.2 |
1.7 |
|
DMSO |
Mean |
11 |
16 |
sd |
5.1 |
4.2 |
|
Acetone |
Mean |
16 |
15 |
sd |
2.6 |
5.1 |
|
Positive |
Mean |
333 |
197 |
sd |
56.8 |
76.4 |
|
f(I) |
23.79 |
12.31 |
|
1.5 µL/plate |
Mean |
5 |
3 |
sd |
0.6 |
0.6 |
|
f(I) |
0.31 |
0.20 |
|
0.75 µL/plate |
Mean |
13 |
14 |
sd |
3.6 |
2.5 |
|
f(I) |
0.81 |
0.93 |
|
0.38 µL/plate |
Mean |
14 |
12 |
sd |
1.0 |
2.5 |
|
f(I) |
0.88 |
0.80 |
|
0.19 µL/plate |
Mean |
12 |
15 |
sd |
1.5 |
3.1 |
|
f(I) |
0.75 |
1.00 |
|
0.09 µL/plate |
Mean |
13 |
8 |
sd |
2.9 |
1.2 |
|
f(I) |
0.81 |
0.53 |
|
0.05 µL/plate |
Mean |
13 |
11 |
sd |
4.2 |
2.6 |
|
f(I) |
0.81 |
0.73 |
|
0.02 µL/plate |
Mean |
13 |
14 |
sd |
2.9 |
3.2 |
|
f(I) |
0.81 |
0.93 |
|
0.01 µL/plate |
Mean |
17 |
13 |
sd |
4.6 |
1.5 |
|
f(I) |
1.06 |
0.87 |
f(I) = increase factor
Table5 Historical Data of Spontaneous Revertants
Strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
Induction |
|
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
Demin. water |
Mean |
89 |
94 |
20 |
22 |
92 |
96 |
279 |
297 |
18 |
18 |
Min |
60 |
63 |
6 |
8 |
51 |
64 |
85 |
67 |
6 |
7 |
|
Max |
144 |
138 |
52 |
51 |
141 |
141 |
425 |
511 |
31 |
33 |
|
SD |
18 |
16 |
11 |
10 |
15 |
14 |
58 |
69 |
6 |
6 |
|
Exp 1a |
73 |
84 |
36 |
33 |
92 |
108 |
249 |
259 |
21 |
22 |
|
Exp 1b |
77 |
86 |
35 |
34 |
86 |
80 |
335 |
329 |
29 |
25 |
|
Exp 2 |
80 |
75 |
34 |
45 |
101 |
117 |
317 |
325 |
14 |
12 |
|
DMSO |
Mean |
88 |
97 |
20 |
21 |
89 |
92 |
278 |
294 |
18 |
17 |
Min |
58 |
67 |
7 |
8 |
44 |
62 |
79 |
80 |
8 |
6 |
|
Max |
135 |
144 |
47 |
50 |
136 |
199 |
393 |
459 |
33 |
32 |
|
SD |
17 |
17 |
11 |
10 |
16 |
17 |
56 |
61 |
6 |
6 |
|
Exp 1a |
74 |
110 |
38 |
36 |
89 |
91 |
239 |
249 |
26 |
18 |
|
Exp 1b |
79 |
71 |
34 |
38 |
75 |
87 |
328 |
283 |
21 |
19 |
|
Exp 2 |
71 |
81 |
41 |
42 |
87 |
92 |
304 |
300 |
11 |
16 |
|
Acetone |
Mean |
66 |
107 |
16 |
19 |
68 |
76 |
335 |
338 |
16 |
16 |
Min |
34 |
61 |
6 |
11 |
52 |
54 |
227 |
223 |
10 |
10 |
|
Max |
88 |
139 |
52 |
51 |
109 |
106 |
525 |
485 |
24 |
25 |
|
SD |
17 |
25 |
11 |
10 |
14 |
14 |
83 |
83 |
4 |
4 |
|
Exp 1a |
74 |
109 |
36 |
35 |
99 |
99 |
288 |
272 |
25 |
23 |
|
Exp 1b |
73 |
77 |
36 |
41 |
81 |
112 |
325 |
300 |
24 |
24 |
|
Exp 2 |
86 |
79 |
39 |
42 |
84 |
120 |
331 |
291 |
16 |
15 |
|
Positive Controls* |
Mean |
537 |
520 |
407 |
113 |
490 |
764 |
1110 |
1213 |
265 |
132 |
Min |
264 |
237 |
100 |
39 |
220 |
273 |
491 |
408 |
55 |
45 |
|
Max |
1165 |
1181 |
1001 |
487 |
984 |
1912 |
2331 |
6083 |
515 |
712 |
|
SD |
173 |
160 |
163 |
90 |
153 |
288 |
423 |
585 |
88 |
82 |
|
Exp 1a |
479 |
463 |
268 |
176 |
379 |
1001 |
657 |
1323 |
220 |
175 |
|
Exp 1b |
584 |
669 |
443 |
451 |
547 |
1001 |
1371 |
1533 |
343 |
243 |
|
Exp 2 |
268 |
368 |
307 |
328 |
372 |
1001 |
663 |
1267 |
333 |
197 |
* Different positive controls were used
1001 colonies per plate means the bacteria growth was too strong for counting.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental condition of the study, 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. Hence, the test item Triisononylamine was not considered as mutagenic for bacteria strain according to CLP criteria.
- Executive summary:
In this GLP compliant in vitro test, the test item Triisononylamine was tested in the Salmonella typhimurium reverse mutation assay with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535) according to OECD TG 471 method.
The test was performed in three experiments in the presence and absence of metabolic activation, with +S9 standing for presence of metabolic activation, and –S9 standing for absence of metabolic activation.
Experiment 1a:
In this experiment, the test item (dissolved in acetone) was tested up to concentrations of 5 µL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100, TA102 and TA1535 using the plate incorporation method. The test item showed no precipitates on the plates at any of the concentrations. In the highest concentration (5 µL/plate), no bacteria growth and no bacterial background lawn was observed. Towards the bacteria strain TA1535, signs of toxicity (decrease in the number of revertants) were observed in the next lower concentration (1.5 µL/plate), too.
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.
Experiment 1b:
In this experiment (repetititon of experiment 1a with lower concentrations), the test item was tested up to concentrations of 5 µL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100 and TA102 and up to concentrations of 1.5 µL/plate in the absence and presence of S9-mix in the strain TA1535 using the plate incorporation method, too. The test item showed no precipitates on the plates at any of the concentrations. 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.
Experiment 2:
Based on the toxicity results of experiment 1a and 1b, the test item was tested up to con-centrations of 5 µL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100 and TA102 and up to concentrations of 1.5 µL/plate in the absence and presence of S9-mix in the strain TA1535 using the pre-incubation method.
Signs of toxicity were observed in the following concentrations with and without metabolic activation towards the resp. bacteria strains:
TA97a: no toxicity was observed
TA98: 5 µL/plate (decrease in the number of revertants)
TA100: 5 and 2.5 µL/plate (decrease in the number of revertants)
TA102: no toxicity was observed
TA1535: 1.5 µL/plate (decrease in the number of revertants)
The results of this experiments showed that the test item caused no increase in the num-ber of revertants in all bacteria strains compared to the solvent control, in both the ab-sence and presence of metabolic activation. The test item 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 Triisononylamine 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. Hence, the test item Triisononylamine was not considered as mutagenic for bacteria strain according to CLP criteria.
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