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EC number: 268-594-6 | CAS number: 68130-51-8
- 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
- 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:
- 26. Sep. 2017 to 06. Oct. 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:
- OECD Guidelines for the Testing of Chemicals Part 471, adopted 21. Jul. 1997 “Bacterial Reverse Mutation Test“
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Commission Regulation (EC) No. 440/2008, EU-Method B.13/14 adopted 30. May 2008 “Mutagenicity –Reverse mutation test using bacteria”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Decanoic acid, mixed esters with heptanoic acid, isovaleric acid, octanoic acid and pentaerythritol
- EC Number:
- 268-594-6
- EC Name:
- Decanoic acid, mixed esters with heptanoic acid, isovaleric acid, octanoic acid and pentaerythritol
- Cas Number:
- 68130-51-8
- Molecular formula:
- C25H44O8 to C45H84O8 (in CH2 unit increments)
- IUPAC Name:
- 3-(heptanoyloxy)-2-[(octanoyloxy)methyl]-2-[(pentanoyloxy)methyl]propyl decanoate; 3-(heptanoyloxy)-2-{[(2-methylbutanoyl)oxy]methyl}-2-[(octanoyloxy)methyl]propyl decanoate
- Test material form:
- liquid
- Details on test material:
- Name Hatcol 1570
Batch no. B29855
Appearance slight yellow, clear liquid
CAS No. 68130-51-8
EINECS-No. 268-594-6
Molecular formula C10-H20-O2.C8-H16-O2.C7-H14-O2.C5-H12-O4.C5-H10-O2
Molecular weight not stated
Purity 99.7 %
Homogeneity homogeneous
Vapour pressure not stated
Stability H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
Solubility H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
Production date 14. Jun. 2017
Expiry date 14. Jun. 2019
Storage Room Temperature (20 ± 5°C)
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 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 second experiment: 5 μL/plate, 2.5 μL/plate, 1.25 μL/plate, 0.63 μL/plate, 0.31 μL/plate, 0.16 μL/plate and 0.08 μL/plate
Justifcation not specified in the study report. - Vehicle / solvent:
- Ethanol 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
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide (DMSO), Demineralised water and Ethanol
- True negative controls:
- no
- 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:
- Description of the Method
General preparation
Per bacteria strain and concentration, three plates with and three plates without metabolic activation (-S9) were used.
For the top agar 100 mL agar basis was melted in a microwave oven, 10 mL of the histidine-biotin-solution 0.5 mM was added, then the mixture was placed in the water bath at 43 ±1 °C.
Plate incorporation method
The following materials were gently vortexed in a test tube and poured onto the selective agar plates:
-100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control)
-500 μL S9 mix or phosphate buffer (for test without metabolic activation).
-100 μL bacteria suspension
-2000 μL overlay agar (top agar)
The plates were closed and left to solidify for a few minutes, then inverted and placed in the dark incubator at 37 ±1 °C.
Pre-incubation method
The following materials were gently vortexed in a test tube and incubated at 37 ±1°C for 20 minutes:
-100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control)
-500 μL S9 mix or phosphate buffer (for test without metabolic activation).
-100 μL bacteria suspension. After the pre-incubation for 20 minutes, 2000 μL top agar was added and the tube was gently vortexed. The mixture was poured onto the selective agar plate.
The plates were closed and left to solidify for a few minutes, then inverted and placed in the incubator at 37 ±1 °C.
References and Validity
Genotype Confirmation
Genotype confirmation is performed for each batch of lyophilized bacteria before stock culture preparation.
Histidine requirement
Each strain was streaked on a biotin and a histidine-biotin-plate, using a sterilized wire loop. The plates were incubated for 24 hours at 37 ±1 °C.
Ampicillin/Tetracycline-Resistance (pKM 101, pAQ1)
Each strain was streaked on an ampicillin agar plate and on an ampicillin-tetracycline agar plate. TA1535 was used as control strain, since it is not ampicillin resistant. The plates were incubated for 24 hours at 37 ±1 °C.
UV-sensitivity (uvrB)
Each strain was streaked on a plate, and one half of the plate covered with aluminium foil so that one half of each streak was protected against light. The plates for the strain TA97a, TA100 and TA102 were irradiated for 8 seconds, the plates for the strain TA 98 were irradiated for 10 seconds and the plates for the strain TA1535 were irradiated for 6 seconds with a germicidal lamp (254 nm, 30W).
Keeping a distance of 33 cm for the strains TA97a, TA102 and TA1535.
Keeping a distance of 66 cm for the following strains: TA98, TA100.
Incubation for 24 hours at 37 ±1 °C followed.
Crystal violet sensitivity (deep rough/rfa)
For each strain, two plates were used. 0.1 mL of bacteria suspension were mixed with 2 mL Top-Agar and poured on nutrient agar. Sterile paper discs ( 9 mm), each soaked with 10 μL of crystal violet solution (0.1%) were placed into the middle of each plate, followed by incubation for 24 hours at 37 ±1°C.
Spontaneous Revertants
Three replicates, with/without S9, for each solvent which was used in the test, incubation for 48 hours at 37 ±1°C.
Determination of Titre
The titre was determined by dilution of the overnight culture using sodium chloride solution and placing 0.1 mL on maximal-soft agar. Incubation for 48 hours at 37 ±1 °C followed. It should give a density of 109 cells/mL (at the least), two replicates with and without metabolic activation.
Toxicity Control
Performed in experiment 1 only analogously to the titre control with the maximum dose of test item on maximal-soft agar, two replicates with and without metabolic activation, incubation for 48 hours at 37 ±1°C.
Sterility Control
Performed analogously to the test with solvent only and S9 (without adding bacteria) on top agar, incubation for 48 hours at 37 ±1°C, four replicates.
Solubility
Plates were checked for precipitation of test item at the end of the incubation by visual inspection.
Positive Controls
Using diagnostic mutagens, three replicates were prepared.
The stock solutions of the substances were diluted to achieve an application volume of 0.1 mL/plate, incubation for 48 hours at 37 ±1°C. - Rationale for test conditions:
- In accordance with the test guidelines.
- Evaluation criteria:
- The colonies were counted visually and the numbers were recorded. A validated spreadsheet software (Microsoft Excel®) was used to calculate mean values and standard deviations 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. - Statistics:
- Not specified.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- not applicable
- 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:
- not applicable
- 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:
- not applicable
- 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
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- First Experiment
Confirmation of the Criteria and Validity
All strains met the criterion of at least 109 bacteria/mL, and no inconsistencies were found in the sterility control. All determined values for the spontaneous revertants of the negative controls 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.
Solubility and Toxicity
In the first experiment, the test item showed no precipitates on the plates in all tested concentrations.
No signs of toxicity towards the bacteria strains could be observed. The bacterial background lawn was visible and not affected. The number of revertant colonies was not reduced.
Mutagenicity
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.
Therefore, the test item is stated as not mutagenic under the test conditions.To verify this result, a further experiment was performed.
Second Experiment
Confirmation of the Criteria and Validity
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 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.
Solubility and Toxicity
In the second experiment, the test item showed no precipitates on the plates in all tested concentrations.
No signs of toxicity towards the bacteria strains could be observed. The bacterial background lawn was visible and not affected. The number of revertant colonies was not reduced.
Mutagenicity
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.
Therefore, the test item is stated as not mutagenic under the test conditions.
Mutagenicity of Test Item
The test item Hatcol 1570 showed no increase in the number of revertants in all bacteria strains in both experiments.
Nearly 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.
Based on the results of this study it is concluded that Hatcol 1570 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 present study.
Acceptability of Study, Discussion
In all experiments, no precipitation of the test item Hatcol 1570 was observed at any of the tested concentrations up to 5 μL/plate.
In both experiments, 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.
Nearly 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 revertant colonies of the positive controls were within the range of the historical data of the laboratory, but all 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.
Any other information on results incl. tables
Mean Revertants First Experiment
Strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
Induction |
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Demin. Water |
Mean |
74 |
73 |
35 |
38 |
94 |
108 |
291 |
288 |
19 |
20 |
sd |
12.4 |
7.5 |
2.0 |
8.6 |
22.5 |
12.2 |
39.5 |
10.6 |
2.0 |
3.5 |
|
DMSO |
Mean |
83 |
81 |
35 |
37 |
83 |
86 |
248 |
225 |
20 |
15 |
sd |
22.7 |
18.5 |
3.2 |
4.0 |
1.2 |
7.5 |
24.0 |
97.9 |
2.5 |
3.6 |
|
Ethanol |
Mean |
79 |
83 |
35 |
43 |
98 |
93 |
211 |
225 |
15 |
16 |
sd |
9.2 |
22.3 |
4.0 |
9.1 |
12.4 |
2.5 |
62.0 |
66.3 |
4.6 |
4.6 |
|
Positive Controls* |
Mean |
587 |
1001 |
493 |
299 |
327 |
557 |
668 |
1488 |
219 |
144 |
sd |
86.3 |
0.0 |
69.0 |
18.5 |
39.3 |
12.2 |
34.9 |
34.9 |
68.0 |
17.8 |
|
f(l) |
7.07 |
12.36 |
14.09 |
8.08 |
3.48 |
6.48 |
2.69 |
6.61 |
11.53 |
9.60 |
|
5 μL/plate |
Mean |
96 |
76 |
38 |
39 |
79 |
113 |
271 |
297 |
24 |
23 |
sd |
12.9 |
4.6 |
7.0 |
7.0 |
13.1 |
15.5 |
28.1 |
24.1 |
4.4 |
2.6 |
|
f(l) |
1.22 |
0.92 |
1.09 |
0.91 |
0.81 |
1.22 |
1.28 |
1.32 |
1.60 |
1.44 |
|
1.5 μL/plate |
Mean |
88 |
73 |
39 |
39 |
107 |
103 |
261 |
315 |
21 |
20 |
sd |
32.1 |
8.0 |
7.2 |
2.1 |
6.4 |
15.1 |
50.0 |
37.0 |
3.1 |
4.5 |
|
f(l) |
1.11 |
0.88 |
1.11 |
0.91 |
1.09 |
1.11 |
1.24 |
1.40 |
1.40 |
1.25 |
|
0.5 μL/plate |
Mean |
96 |
85 |
60 |
68 |
99 |
81 |
244 |
319 |
19 |
23 |
sd |
12.2 |
10.5 |
2.3 |
8.9 |
7.8 |
6.1 |
54.1 |
68.0 |
2.1 |
7.2 |
|
f(l) |
1.22 |
1.02 |
1.71 |
0.88 |
1.01 |
0.87 |
1.16 |
1.42 |
1.27 |
1.44 |
|
0.15 μL/plate |
Mean |
90 |
82 |
38 |
34 |
83 |
92 |
332 |
271 |
17 |
17 |
sd |
15.0 |
16.1 |
1.2 |
3.2 |
16.5 |
19.1 |
27.7 |
44.1 |
4.2 |
3.0 |
|
f(l) |
1.14 |
0.99 |
1.09 |
0.79 |
0.85 |
0.99 |
1.57 |
1.20 |
1.13 |
1.06 |
|
0.05 μL/plate |
Mean |
74 |
77 |
33 |
36 |
86 |
112 |
181 |
209 |
18 |
16 |
sd |
1.5 |
6.5 |
2.1 |
3.1 |
7.2 |
22.7 |
8.1 |
15.1 |
4.5 |
5.0 |
|
f(l) |
0.94 |
0.93 |
0.94 |
0.84 |
0.88 |
1.20 |
0.86 |
0.93 |
1.20 |
1.00 |
f(l) = increase factor
* Different positive controls were used
Mean Revertants Second Experiment
Strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
Induction |
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Demin. Water |
Mean |
90 |
79 |
35 |
37 |
114 |
100 |
307 |
356 |
22 |
23 |
sd |
9.0 |
7.6 |
6.9 |
5.3 |
18.7 |
16.4 |
10.1 |
10.6 |
3.5 |
2.9 |
|
DMSO |
Mean |
88 |
83 |
40 |
39 |
114 |
109 |
291 |
329 |
20 |
21 |
sd |
4.0 |
10.4 |
11.8 |
4.0 |
3.5 |
8.1 |
11.5 |
39.3 |
0.6 |
1.2 |
|
Ethanol |
Mean |
80 |
81 |
38 |
38 |
109 |
96 |
260 |
363 |
15 |
17 |
sd |
9.8 |
8.7 |
9.9 |
3.0 |
5.0 |
15.9 |
65.5 |
41.1 |
5.0 |
4.0 |
|
Positive Controls* |
Mean |
365 |
915 |
685 |
188 |
341 |
816 |
1235 |
1235 |
346 |
153 |
sd |
14.7 |
28.1 |
92.4 |
38.0 |
20.1 |
83.1 |
119.8 |
180.0 |
50.3 |
12.9 |
|
f(l) |
4.15 |
11.02 |
17.13 |
4.82 |
2.99 |
7.49 |
4.24 |
3.75 |
15.73 |
7.29 |
|
5 μL/plate |
Mean |
80 |
100 |
36 |
33 |
114 |
115 |
385 |
392 |
21 |
23 |
sd |
16.2 |
11.0 |
5.0 |
3.1 |
8.1 |
36.3 |
34.9 |
60.5 |
2.9 |
2.5 |
|
f(l) |
1.00 |
1.23 |
0.95 |
0.87 |
1.05 |
1.20 |
1.48 |
1.08 |
1.40 |
1.35 |
|
2.5 μL/plate |
Mean |
100 |
72 |
41 |
34 |
101 |
97 |
325 |
287 |
20 |
19 |
sd |
9.5 |
6.0 |
2.0 |
10.1 |
18.1 |
21.7 |
50.3 |
4.6 |
1.2 |
4.0 |
|
f(l) |
1.25 |
0.89 |
1.08 |
0.89 |
0.93 |
1.01 |
1.25 |
0.79 |
1.33 |
1.12 |
|
1.25 μL/plate |
Mean |
96 |
101 |
36 |
39 |
78 |
96 |
257 |
233 |
18 |
20 |
sd |
18.2 |
11.5 |
4.7 |
3.2 |
3.8 |
20.6 |
77.6 |
37.2 |
2.9 |
3.5 |
|
f(l) |
1.20 |
1.25 |
0.95 |
1.03 |
0.72 |
1.00 |
0.99 |
0.64 |
1.20 |
1.18 |
|
0.63 μL/plate |
Mean |
100 |
83 |
35 |
30 |
122 |
114 |
268 |
257 |
22 |
14 |
sd |
10.1 |
7.2 |
7.2 |
9.5 |
1.2 |
2.0 |
46.1 |
55.6 |
1.5 |
2.1 |
|
f(l) |
1.25 |
1.02 |
0.92 |
0.79 |
1.12 |
1.19 |
1.03 |
0.71 |
1.47 |
0.82 |
|
0.31 μL/plate |
Mean |
67 |
83 |
33 |
31 |
107 |
97 |
347 |
276 |
19 |
19 |
sd |
10.4 |
5.2 |
6.0 |
5.5 |
5.0 |
21.9 |
8.3 |
14.4 |
5.3 |
1.2 |
|
f(l) |
0.84 |
1.02 |
0.87 |
0.82 |
0.98 |
1.01 |
1.33 |
0.76 |
1.27 |
1.12 |
|
0.16 μL/plate |
Mean |
77 |
99 |
36 |
41 |
108 |
114 |
333 |
355 |
20 |
19 |
sd |
9.0 |
27.5 |
3.5 |
2.5 |
8.1 |
2.0 |
16.2 |
31.1 |
3.2 |
1.5 |
|
f(l) |
0.96 |
1.22 |
0.95 |
1.08 |
0.99 |
1.19 |
1.28 |
0.98 |
1.33 |
1.12 |
|
0.08 μL/plate |
Mean |
84 |
91 |
39 |
35 |
115 |
108 |
290 |
344 |
20 |
18 |
sd |
7.0 |
13.2 |
10.4 |
5.1 |
10.1 |
3.2 |
93.6 |
48.7 |
2.9 |
3.2 |
|
f(l) |
1.05 |
1.12 |
1.03 |
0.92 |
1.06 |
1.13 |
1.12 |
0.95 |
1.33 |
1.06 |
f(l) = increase factor
* Different positive controls were used
Historical Data of Spontaneous Revertants
Strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
Induction |
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Demin. H2O |
Mean |
91 |
96 |
17 |
19 |
92 |
97 |
280 |
298 |
17 |
17 |
Min |
60 |
63 |
6 |
8 |
51 |
64 |
85 |
67 |
6 |
7 |
|
Max |
144 |
138 |
52 |
50 |
141 |
141 |
425 |
511 |
31 |
33 |
|
SD |
19 |
16 |
9 |
8 |
16 |
15 |
62 |
74 |
6 |
6 |
|
Exp 1 |
74 |
73 |
35 |
38 |
94 |
108 |
291 |
288 |
19 |
23 |
|
Exp 2 |
90 |
79 |
35 |
37 |
114 |
100 |
307 |
356 |
22 |
23 |
|
DMSO |
Mean |
90 |
100 |
17 |
18 |
90 |
92 |
279 |
294 |
17 |
17 |
Min |
58 |
67 |
7 |
8 |
44 |
62 |
79 |
80 |
8 |
6 |
|
Max |
135 |
144 |
46 |
41 |
136 |
199 |
393 |
459 |
33 |
32 |
|
SD |
18 |
17 |
9 |
9 |
16 |
18 |
59 |
66 |
7 |
6 |
|
Exp 1 |
83 |
81 |
35 |
37 |
83 |
86 |
248 |
225 |
20 |
15 |
|
Exp 2 |
88 |
83 |
40 |
39 |
114 |
109 |
291 |
329 |
20 |
21 |
|
Ethanol |
Mean |
88 |
99 |
19 |
20 |
86 |
91 |
287 |
276 |
17 |
17 |
Min |
57 |
65 |
8 |
9 |
61 |
69 |
111 |
141 |
9 |
9 |
|
Max |
181 |
205 |
47 |
45 |
116 |
129 |
368 |
339 |
29 |
36 |
|
SD |
23 |
28 |
11 |
10 |
13 |
16 |
50 |
44 |
6 |
7 |
|
Exp 1 |
79 |
83 |
35 |
43 |
98 |
93 |
211 |
225 |
15 |
16 |
|
Exp 2 |
80 |
81 |
38 |
38 |
109 |
96 |
260 |
363 |
15 |
17 |
|
Positive Controls* |
Mean |
552 |
506 |
397 |
95 |
512 |
736 |
1142 |
1232 |
257 |
119 |
Min |
264 |
237 |
100 |
39 |
223 |
273 |
491 |
408 |
55 |
45 |
|
Max |
1152 |
1181 |
793 |
487 |
984 |
1912 |
2331 |
6083 |
484 |
712 |
|
SD |
165 |
148 |
139 |
74 |
151 |
300 |
443 |
636 |
86 |
77 |
|
Exp 1 |
587 |
1001 |
493 |
299 |
327 |
557 |
668 |
1488 |
219 |
144 |
|
Exp 2 |
365 |
915 |
685 |
188 |
341 |
816 |
1235 |
1235 |
346 |
153 |
*Different positive controls were used
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study it is concluded that Hatcol 1570 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 the study.
- Executive summary:
Determination of the mutagenic potential of Hatcol 1570 with the Bacterial Reverse Mutation Test following OECD 471 and EU B.13/14
Findings and Results:
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 Hatcol 1570 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 metabolic activation, with +S9 standing for presence of metabolic activation, and –S9 standing for absence of metabolic activation.
In the first experiment, the test item (dissolved in ethanol) 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.
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 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.
Based on the first experiment, the test item was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in all bacteria strains using the pre-incubation method.
The test item 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 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 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 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 the study it is concluded that Hatcol 1570 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 the study.
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