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EC number: 823-780-1 | CAS number: 1034820-43-3
- 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:
- From January 19th to January 27th, 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guidelineopen allclose all
- 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 May 30th, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted June 26th, 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction products of 3,3'-thiodi(propionic acid) and alcohols, C11-14-iso-, C13-rich
- EC Number:
- 823-780-1
- Cas Number:
- 1034820-43-3
- Molecular formula:
- UVCB substance
- IUPAC Name:
- Reaction products of 3,3'-thiodi(propionic acid) and alcohols, C11-14-iso-, C13-rich
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: All Salmonella typhimurium strains were obtained from Trinova BioChem GmbH (batch: TA98: 5508D, TA100: 5526D, TA102: 5524D, TA1535: 5504D, TA1537:5530D) and were stored as lyophilizates in the refrigerator at 2 – 8 °C.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- S9 was obtained by Trinova Biochem GmbH, Gießen.
- source of S9: livers of male Sprague-Dawley rats which were treated with Phenobarbital/5,6-Benzoflavone.
- composition of S9 mix:
Phosphate buffer 22.5 mL
0.1M NADP-solution 1.0 mL
1M G6P-solution 0.125 mL
Salt solution 0.5 mL
Rat liver S9 1.0 mL
- concentration or volume of S9 mix in the final culture medium: 500 µL - Test concentrations with justification for top dose:
- The following nominal test item concentrations were prepared for experiment 1 (Plate incorporation method):
5, 1.5, 0.5, 0.15 and 0.05 µL/plate.
The following nominal test item concentrations were prepared for experiment 2 (Pre-incubation method):
5, 2.5, 1.25, 0.63, 0.31 and 0.16 µL/plate.
The justification for the top dose is that, based on OECD 471, The recommended maximum test concentration for soluble non-cytotoxic substances is 5 mg/plate or 5 μl/plate. - Vehicle / solvent:
- In a non-GLP pre-test, the solubility of the test item was tested at in a concentration of 50 mL/L in demineralized (demin.) water, dimethyl sulfoxide (DMSO), acetone and ethanol. The liquid test item is sufficiently soluble in ethanol and acetone. Based on the non-GLP pre-test, 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.
Dimethylsulfoxide (DMSO) was used for the positive controls 4-Nitro-1,2-phenylene diamine, benzo-a-pyrene and 2-amino-anthracene.
Demineralized water, prepared by LAUS GmbH, from an ion-exchanger, was used for for the positive controls sodium azide and mitomycin C.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other:
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: Three plates with (+S9) and three plates without metabolic activation (-S9) were used per bacteria strain and concentration.
- Number of independent experiments: 2 indipendent experiments. The first was performed with the plate incorporation method. The second was performed with the pre-incubation methods.
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding: 10^9 cells/mL
- Plate incorporation method (first experiment): 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-mixfor test with metabolic activation 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.
- Preincubation method (second experiment): 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 for test with metabolic activation 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 slewed. 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.
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 20 minutes at 37 C° only for the second experiment.
- Exposure duration/duration of treatment: 48 h
- Temperature: 37 °C ± 1 °C.
REFERENCES AND VALIDITY:
- Genotype Confirmation: Confirmation of genotype is performed for each batch of lyophilized bacteria by the supplier Trinova BioChem GmbH. The batches used of lyophilized bacteria met the criteria.
- Spontaneous Revertants: The number of spontaneous revertants was determined for each solvent, used in the test by investigating three replicates with and without metabolic activation, incubation for 48 hours at 37 ± 1 °C for each strain.
- 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. It should give a density of 10^9 cells/mL (at the least). Two replicates with and without metabolic activation, incubation for 48 hours at 37 ± 1 °C.
- Sterility Control: Performed analogously to the test item but with solvent only and S9 (without adding bacteria) on top agar. Four replicates, incubation for 48 hours at 37 ± 1 °C.
- Solubility: Plates were checked for precipitation of test item at the end of the incubation by visual inspection.
- Positive Controls: Using diagnostic mutagens. The stock solutions of the substances were diluted to achieve an application volume of 0.1 mL/plate. Three replicates with and without metabolic activation, incubation for 48 hours at 37 ± 1 °C.
EVALUATION:
Five different analysable concentrations were used for the evaluation of the mutagenic potential of the test item.
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 deviations of each treatment, negative control and positive control.
The mean values and standard deviations of each threefold determination were calculated as well as the increase factor 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 (mean revertants minus mean spontaneous revertants) is given. - Evaluation criteria:
- A result is considered as clearly positive if all the following criteria are fulfilled:
• A concentration-related increase, in revertants
• A clear biological relevant increase in at least one concentration compared to the con-current solvent control
• At least one concentration with an increase above the distribution of historical solvent control data (mean ± 3 SD).
Results and discussion
Test resultsopen allclose all
- 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 examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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 examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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 examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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 examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- EXPERIMENT 1 (PLATE INCORPORATION METHOD):
- Confirmation of the Criteria and Validity: All strains met the criterion of at least 10^9 bacteria/mL (correlating to 100 colonies/plate after dilution), and no inconsistencies were found in the sterility control. All determined values for the spontaneous revertants of the vehicle and negative controls were in the normal range of the test laboratory (mean ± 3 standard deviations). All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and all were within the historical control data ranges.
- Solubility and Toxicity: In exp. 1, the test item showed no precipitates on the plates in all tested concentrations. The bacterial background lawn was visible and not affected. The number of revertant col-onies was not relevantly reduced. Thus, no signs of toxicity towards the bacteria strains could be observed.
- Mutagenicity: No relevant or concentration-related increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed.
To verify this result, a further experiment (exp. 2) was performed with adapted conditions (pre-incubation method).
EXPERIMENT 2 (PRE-INCUBATION METHOD):
- Confirmation of the Criteria and Validity: All strains met the criterion of at least 10^9 bacteria/mL (correlating to 100 colonies/plate after dilution), and no inconsistencies were found in the sterility control. All determined values for the spontaneous revertants of the vehicle and negative controls were in the normal range of the test laboratory (mean ± 3 standard deviations). All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and all were within the historical control data ranges.
- Solubility and Toxicity: In exp. 2, the test item showed no precipitates on the plates in all tested concentrations. The bacterial background lawn was visible and not affected. The number of revertant col-onies was not relevantly reduced. Thus, no signs of toxicity towards the bacteria strains could be observed.
- Mutagenicity: No relevant or concentration-related increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed.
Any other information on results incl. tables
Μutagenicity Experiment I - plate incorporation test - Strain: S. typhimurium TA 98 | Μutagenicity Experiment II - pre-incubation test - Strain: S. typhimurium TA 98 | ||||||||||||||||||||||
without metabolic activation | with metabolic activation | Conclusion | without metabolic activation | with metabolic activation | Conclusion | ||||||||||||||||||
Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | ||||||||||
water | 13 | 13 | 14 | 13±0,6 | - | 14 | 17 | 18 | 16±2,1 | - | valid | water | 10 | 12 | 12 | 11± 1,2 | - | 14 | 16 | 16 | 15± 1,2 | - | valid |
EtOH | 12 | 13 | 14 | 13±1 | - | 13 | 15 | 19 | 16±3,1 | - | EtOH | 8 | 10 | 11 | 10± 1,5 | - | 10 | 12 | 16 | 13± 3,1 | - | ||
DMSO | 15 | 15 | 16 | 15±0,6 | - | 16 | 16 | 19 | 17±1,7 | - | DMSO | 9 | 10 | 10 | 10± 0,6 | - | 9 | 13 | 15 | 13± 3,1 | - | ||
5 | 14 | 14 | 16 | 15±01,2 | 1,15 | 14 | 18 | 18 | 17±2,3 | 1,06 | not mutagenic | 5 | 8 | 9 | 12 | 10± 2,1 | 1 | 11 | 12 | 15 | 13± 2,1 | 1 | not mutagenic |
1,5 | 12 | 14 | 17 | 14±2,5 | 1,08 | 13 | 17 | 18 | 16±2,6 | 1 | 2,5 | 8 | 8 | 13 | 10± 2,9 | 1 | 8 | 11 | 16 | 12± 4 | 0,92 | ||
0,5 | 13 | 13 | 13 | 13±0,0 | 1 | 13 | 14 | 18 | 15±2,6 | 0,94 | 1,25 | 7 | 10 | 10 | 9± 1,7 | 0,9 | 11 | 11 | 15 | 12± 2,3 | 0,92 | ||
0,15 | 12 | 12 | 13 | 12±0,6 | 0,92 | 14 | 15 | 16 | 15±1,0 | 0,94 | 0,63 | 10 | 11 | 14 | 12± 2,1 | 1,2 | 11 | 12 | 18 | 14± 3,8 | |||
0,05 | 12 | 13 | 19 | 15±3,8 | 1,15 | 13 | 17 | 17 | 16±2,3 | 1 | 0,31 | 9 | 10 | 10 | 10± 0,6 | 1 | 10 | 16 | 17 | 14± 3,8 | 1,08 | ||
NDP/BaP | 556 | 560 | 564 | 560±4 | 37,33 | 80 | 94 | 95 | 90±8,4 | 5,29 | valid | NDP/BaP | 512 | 560 | 576 | 549± 33,3 | 54,9 | 92 | 96 | 104 | 97± 6,1 | 8,08 | |
Μutagenicity Experiment I - plate incorporation - Strain: S. typhimurium TA 100 | Μutagenicity Experiment II - pre-incubation test - Strain: S. typhimurium TA 100 | ||||||||||||||||||||||
without metabolic activation | with metabolic activation | Conclusion | without metabolic activation | with metabolic activation | Conclusion | ||||||||||||||||||
Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | ||||||||||
water | 60 | 65 | 69 | 65± 4,5 | - | 60 | 66 | 68 | 65± 4,2 | - | valid | water | 52 | 67 | 70 | 63± 9,6 | - | 56 | 60 | 62 | 59± 3,1 | - | valid |
EtOH | 53 | 59 | 66 | 59± 6,5 | - | 56 | 56 | 60 | 57± 2,3 | - | EtOH | 48 | 56 | 60 | 55± 6,1 | - | 53 | 56 | 57 | 55± 2,1 | - | ||
DMSO | 60 | 66 | 70 | 65± 5 | - | 64 | 68 | 70 | 67± 3,1 | - | DMSO | 52 | 55 | 69 | 59± 9,1 | - | 53 | 54 | 70 | 59± 9,5 | - | ||
5 | 66 | 70 | 73 | 70± 3,5 | 1,19 | 54 | 57 | 58 | 56± 2,1 | 0,98 | not mutagenic | 5 | 43 | 56 | 57 | 52± 7,8 | 0,95 | 46 | 54 | 59 | 53± 6,6 | 0,96 | not mutagenic |
1,5 | 56 | 61 | 68 | 62± 6 | 1,05 | 53 | 56 | 57 | 55± 2,1 | 0,96 | 2,5 | 47 | 52 | 58 | 52± 5,5 | 0,95 | 47 | 50 | 60 | 52± 6,8 | 0,95 | ||
0,5 | 56 | 58 | 62 | 59± 3,1 | 1 | 60 | 61 | 67 | 63± 3,8 | 1,11 | 1,25 | 47 | 49 | 53 | 50± 3,1 | 0,91 | 50 | 55 | 57 | 54± 3,6 | 0,98 | ||
0,15 | 58 | 58 | 60 | 59± 1,2 | 1 | 57 | 61 | 64 | 61± 3,5 | 1,07 | 0,63 | 41 | 43 | 50 | 45± 4,7 | 0,82 | 45 | 47 | 53 | 48± 4,2 | 0,87 | ||
0,05 | 65 | 66 | 68 | 66± 1,5 | 1,12 | 56 | 60 | 62 | 59± 3,1 | 1,04 | 0,31 | 47 | 49 | 54 | 50± 3,6 | 0,91 | 50 | 54 | 56 | 53± 3,1 | 0,96 | ||
Na-azide/2-AA | 496 | 536 | 568 | 533±36,1 | 8,2 | 1112 | 1168 | 1208 | 1163± 48,2 | 17,36 | valid | Na-azide/2-AA | 400 | 448 | 536 | 461± 69 | 7,32 | 1176 | 1208 | 1240 | 1208± 32 | 20,47 | valid |
Μutagenicity Experiment I - plate incorporation test - Strain: S. typhimurium TA 102 | Μutagenicity Experiment II - pre-incubation test - Strain: S. typhimurium TA 102 | ||||||||||||||||||||||
without metabolic activation | with metabolic activation | Conclusion | without metabolic activation | with metabolic activation | Conclusion | ||||||||||||||||||
Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | ||||||||||
water | 148 | 156 | 160 | 155± 6,1 | - | 144 | 144 | 148 | 145± 2,3 | - | valid | water | 152 | 156 | 164 | 157± 6,1 | - | 148 | 164 | 164 | 159± 9,2 | - | valid |
EtOH | 140 | 152 | 160 | 151± 10,1 | - | 136 | 144 | 156 | 145± 10,1 | - | EtOH | 140 | 156 | 160 | 152± 10,6 | - | 156 | 172 | 176 | 168± 10,6 | - | ||
DMSO | 144 | 152 | 164 | 153± 10,1 | - | 140 | 160 | 160 | 153± 11,5 | - | DMSO | 140 | 152 | 168 | 153± 14 | - | 148 | 156 | 164 | 156± 8 | - | ||
5 | 148 | 156 | 160 | 155± 6,1 | 1.03 | 148 | 152 | 164 | 155± 8,3 | 1.07 | not mutagenic | 5 | 144 | 148 | 164 | 152± 10,6 | 1 | 136 | 144 | 160 | 147± 12,2 | 0,88 | not mutagenic |
1,5 | 144 | 148 | 160 | 151± 8,3 | 1.00 | 140 | 148 | 152 | 147± 6,3 | 1.01 | 2,5 | 144 | 148 | 156 | 149± 6,1 | 0,98 | 160 | 164 | 164 | 163± 2,3 | 0,97 | ||
0,5 | 136 | 136 | 140 | 137± 2,3 | 0.91 | 132 | 136 | 144 | 137± 6,1 | 0.94 | 1,25 | 144 | 152 | 164 | 153± 10,1 | 1,01 | 148 | 160 | 164 | 157± 8,3 | 0,93 | ||
0,15 | 132 | 144 | 156 | 144± 12 | 0.95 | 132 | 132 | 136 | 133± 2,3 | 0.92 | 0,63 | 144 | 156 | 164 | 155± 10,1 | 1,02 | 160 | 168 | 172 | 167± 6,1 | 0,99 | ||
0,05 | 132 | 140 | 160 | 144± 14,4 | 0.95 | 128 | 136 | 156 | 140± 14,4 | 0.97 | 0,31 | 144 | 148 | 160 | 151± 8,3 | 0,99 | 164 | 172 | 172 | 169± 4,6 | 1,01 | ||
MMC/2-AA | 480 | 484 | 528 | 497±26,6 | 3,34 | 472 | 484 | 500 | 485±14,0 | 3,17 | valid | MMC/2-AA | 808 | 872 | 904 | 861±48,9 | 5,48 | 1016 | 1048 | 1120 | 1061±53,3 | 6,8 | valid |
Μutagenicity Experiment I - plate incorporation test - Strain: S. typhimurium TA 1535 | Μutagenicity Experiment II - pre-incubation test - Strain: S. typhimurium TA 1535 | ||||||||||||||||||||||
without metabolic activation | with metabolic activation | Conclusion | without metabolic activation | with metabolic activation | Conclusion | ||||||||||||||||||
Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | ||||||||||
water | 7 | 8 | 8 | 8± 0,6 | - | 8 | 8 | 10 | 9± 1,2 | - | valid | water | 7 | 9 | 9 | 8± 1,2 | - | 6 | 6 | 7 | 6± 0,6 | - | valid |
EtOH | 7 | 8 | 8 | 8± 0,6 | - | 9 | 9 | 11 | 10± 1,2 | - | EtOH | 5 | 6 | 6 | 6± 0,6 | - | 8 | 8 | 8 | 8± 0,00 | - | ||
DMSO | 7 | 7 | 7 | 7± 0,0 | - | 7 | 8 | 9 | 8± 1,0 | - | DMSO | 6 | 7 | 8 | 7± 1 | - | 6 | 7 | 9 | 7± 1,5 | - | ||
5 | 7 | 8 | 9 | 8± 1,0 | 1 | 7 | 8 | 9 | 8± 1,0 | 0,8 | not mutagenic | 5 | 5 | 6 | 8 | 6± 1,5 | 1 | 6 | 7 | 7 | 7± 0,6 | 0,88 | not mutagenic |
1,5 | 8 | 9 | 10 | 9± 1 | 1,13 | 7 | 9 | 11 | 9± 2 | 0,9 | 2,5 | 5 | 6 | 7 | 6± 1 | 1 | 6 | 7 | 10 | 8± 2,1 | 1 | ||
0,5 | 8 | 8 | 9 | 8± 0,6 | 1 | 7 | 7 | 8 | 7± 0,6 | 0,7 | 1,25 | 7 | 8 | 8 | 8± 0,6 | 1,33 | 7 | 8 | 9 | 8± 1 | 1 | ||
0,15 | 8 | 9 | 10 | 9± 1 | 1,13 | 9 | 9 | 11 | 10± 1,2 | 1 | 0,63 | 6 | 7 | 8 | 7± 1 | 1,17 | 7 | 7 | 9 | 8± 1,2 | 1 | ||
0,05 | 8 | 9 | 9 | 9± 0,6 | 1,13 | 8 | 9 | 11 | 9± 1,5 | 0,9 | 0,31 | 7 | 8 | 9 | 8± 1 | 1,33 | 6 | 6 | 7 | 6± 0,6 | 0,75 | ||
Na-azide/2-AA | 184 | 152 | 190 | 175±20,4 | 21,88 | 88 | 111 | 114 | 104± 14,2 | 13 | valid | Na-azide/2-AA | 132 | 136 | 158 | 142±14,0 | 17,75 | 120 | 148 | 160 | 143± 20,5 | 20,43 | valid |
Μutagenicity Experiment I - plate incorporation test - Strain: S. typhimurium TA 1537 | Μutagenicity Experiment II - pre-incubation test - Strain: S. typhimurium TA 1537 | ||||||||||||||||||||||
without metabolic activation | with metabolic activation | Conclusion | without metabolic activation | with metabolic activation | Conclusion | ||||||||||||||||||
Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | Test item (μL per plate) | Revertants per plate | mean ± sd | Rt/Rc | Revertants per plate | mean ± sd | Rt/Rc | ||||||||||
water | 3 | 4 | 6 | 4± 1,5 | - | 4 | 4 | 5 | 4± 0,6 | - | valid | water | 3 | 3 | 5 | 4± 1,2 | - | 5 | 5 | 6 | 5± 0,6 | - | valid |
EtOH | 3 | 3 | 5 | 4± 1,2 | - | 3 | 5 | 6 | 5± 1,5 | - | EtOH | 2 | 3 | 4 | 3± 1 | - | 3 | 4 | 6 | 4± 1,5 | - | ||
DMSO | 3 | 5 | 7 | 5± 2 | - | 4 | 5 | 6 | 5± 1 | - | DMSO | 4 | 5 | 5 | 5± 0,6 | - | 3 | 3 | 6 | 4± 1,7 | - | ||
5 | 4 | 5 | 6 | 5± 1 | 1,25 | 3 | 5 | 5 | 4± 1,2 | 0,8 | not mutagenic | 5 | 3 | 3 | 3 | 3± 0,00 | 1 | 3 | 4 | 5 | 4± 1 | 1 | not mutagenic |
1,5 | 3 | 4 | 6 | 4± 1,5 | 1 | 3 | 4 | 8 | 5± 2,6 | 1 | 2,5 | 2 | 3 | 4 | 3± 1 | 1 | 4 | 5 | 6 | 5± 1 | 1,25 | ||
0,5 | 3 | 4 | 8 | 5± 2,6 | 1,25 | 4 | 4 | 4 | 4± 0 | 0,8 | 1,25 | 3 | 3 | 3 | 3± 0,00 | 1 | 2 | 3 | 4 | 3± 1 | 0,75 | ||
0,15 | 3 | 4 | 7 | 5± 2,1 | 1,25 | 5 | 6 | 6 | 6± 0,6 | 1,2 | 0,63 | 3 | 3 | 3 | 3± 0,00 | 1 | 4 | 4 | 5 | 4± 0,6 | 1 | ||
0,05 | 3 | 3 | 8 | 5± 2,9 | 1,25 | 3 | 6 | 7 | 5± 2,1 | 1 | 0,31 | 3 | 3 | 3 | 3± 0,00 | 1 | 3 | 4 | 4 | 4± 0,6 | 1 | ||
NDP/2-AA | 52 | 61 | 68 | 60±8 | 12 | 81 | 89 | 91 | 87±5,3 | 17,4 | valid | NDP/2-AA | 65 | 73 | 83 | 74±9 | 14,8 | 50 | 54 | 61 | 55±5,6 | 13,75 | valid |
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Di(tridecyl) 3,3'-thiodipropionate is not mutagenic in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in the presence and absence of metabolic activation under the experimental conditions of this study.
- Executive summary:
This study was performed in order to evaluate the mutagenic potential of Di(tridecyl) 3,3'-thiodipropionate in the Bacterial Reverse Mutation Test using five strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535 and TA1537) based on the most recent Guidelines OECD 471 (2020) and EU Method B.13/14 (2008). The test was performed in two valid experiments at a cell density of 10^9 cells/mL in the presence and absence of metabolic activation, with +S9 standing for the presence of a 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 TA98, TA100, TA102, TA1535 and TA1537 using the plate incorporation method. The test item showed no precipitates on the plates at any of the concentrations and no signs of cytotoxicity could be observed in the presence and the absence of metabolic activation. The results of this experiment showed that none of the tested concentrations induced a relevant or concentration-related increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation. Therefore, a further experiment with adapted conditions (pre-incubation method) was performed (exp. 2).
Based on the results of the first experiment, the test item was tested up to concentrations of 5 µL/plate in the presence and absence 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 and no signs of cytotoxicity could be observed in the presence and the absence of metabolic activation.
The results of this experiment showed that none of the tested concentrations induced a relevant or concentration-related increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.
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