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EC number: 202-605-7 | CAS number: 97-74-5
- 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:
- weight of evidence
- Study period:
- 15 May 2012 - 09 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines; adequate consistence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (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:
- tetramethylthiuram monosulfide
- IUPAC Name:
- tetramethylthiuram monosulfide
- Reference substance name:
- Tetramethylthiuram monosulphide
- EC Number:
- 202-605-7
- EC Name:
- Tetramethylthiuram monosulphide
- Cas Number:
- 97-74-5
- Molecular formula:
- C6H12N2S3
- IUPAC Name:
- N,N-dimethyl[(dimethylcarbamothioyl)sulfanyl]carbothioamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: Tetramethylthiuram monosulfide
- Physical state: yellow powder
- CAS number: 97-74-5
- Lot/batch No.: 12012103161
- Analytical purity: 99.8%
- Expiry date: 31 January 2013
- Storage conditions: at room temperature protected from humidity and heat.
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- Without S9: 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate or both mutagenicity experiments.
With S9 : 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for both mutagenicity experiments. - Vehicle / solvent:
- - Vehicle used: dimethylsulfoxide
- Justification for choice: test item was soluble in the vehicle at 100 mg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 9-aminoacridine, 2-nitrofluorene, mitomycin C (-S9 mix); 2-anthramine, benzo(a)pyrene (+S9 mix)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the pre-incubation method (60 minutes, 37°C).
Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to at least five dose-levels of the test item (three plates/dose level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertant colonies and/or thinning of the bacterial lawn - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account.
- Statistics:
- no
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/ml (with S9) only
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- 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 applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Experiments without S9 mix : The selected treatment-levels for both mutagenicity experiments were: 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate. No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels, in any experiments. No noteworthy toxicity (decrease in the number of revertants or thinning of the bacterial lawn) was noted at any dose-levels towards the five strains used, in any experiments. Noteworthy increases in the number of revertants were noted in the TA 100 strain in the first and second experiments. These increases exceeded the threshold of 2-fold the vehicle control (up to 2.3-fold), were dose-related and reproducible. They were therefore considered as biologically significant. The test item did not induce any other noteworthy or biologically significant increases in the number of revertants in the other tested strains
Experiments with S9 mix : The selected treatment-levels were: 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for both mutagenicity experiments.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels, in any experiments. A strong toxicity (thinning of the bacterial lawn) was noted at 5000 µg/plate towards the TA 1537 strain, in the first experiment only. No noteworthy toxicity (decrease in the number of revertants or thinning of the bacterial lawn) was noted towards the other strains used, in any experiments. Increases in the number of revertants were noted in the TA 1535 strain in the first and second experiments. These increases exceeded the threshold of 3-fold the vehicle control (up to 3.2-fold and 6.7-fold the vehicle control in the first and second experiments, respectively). Even if they were not dose-related, the increases observed in the first assay were reproduced in the second experiment performed under the pre-incubation method. Moreover, the corresponding means and individual revertant colony counts were above the historical data range of the vehicle control. Consequently, these increases were considered to be biologically significant. Using the direct plate incorporation method (first experiment), increases in the number of revertants were noted in the TA 100 strain at dose-levels = 1250 µg/plate. These increases did not reach the threshold of 2 -fold the vehicle control but the corresponding means and individual revertant colony counts were above the historical data range of the vehicle control.
Increases in the number of revertants were also noted in the second experiment performed using the pre-incubation method. These increases exceeded the threshold of 2-fold the vehicle control at all tested dose-levels (up to 3.7 -fold). Moreover, the corresponding means and individual revertant colony counts were above the historical data range of the vehicle control. Consequently, these increases were considered to be biologically significant. The test item did not induce any other noteworthy or biologically significant increases in the number of revertants in the other tested strains.
Applicant's summary and conclusion
- Conclusions:
- The test item, Tetramethylthiuram monosulfide, showed mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium in the absence and in the presence of a metabolic activation system.
- Executive summary:
The objective of this study was to evaluate the potential of the test item to induce reverse mutation in Salmonella typhimurium.
The study was performed according to the international guidelines (OECD No. 471 and Council Regulation No. 440/2008 of 30 May 2008, Part B13/14) and in compliance with the principles of Good Laboratory Practice.
A preliminary toxicity test was performed to define the dose-levels of Tetramethylthiuram monosulfide to be used for the mutagenicity study. The test item was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the pre-incubation method (60 minutes, 37°C). Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to at least five dose-levels of the test item (three plates/dose-level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The test item Tetramethylthiuram monosulfide was dissolved in dimethylsulfoxide (DMSO).
Experiments without S9 mix : The selected treatment-levels for both mutagenicity experiments were: 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate. No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels, in any experiments. No noteworthy toxicity (decrease in the number of revertants or thinning of the bacterial lawn) was noted at any dose-levels towards the five strains used, in any experiments. Noteworthy increases in the number of revertants were noted in the TA 100 strain in the first and second experiments. These increases exceeded the threshold of 2-fold the vehicle control (up to 2.3-fold), were dose-related and reproducible. They were therefore considered as biologically significant. The test item did not induce any other noteworthy or biologically significant increases in the number of revertants in the other tested strains
Experiments with S9 mix : The selected treatment-levels were: 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for both mutagenicity experiments.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels, in any experiments. A strong toxicity (thinning of the bacterial lawn) was noted at 5000 µg/plate towards the TA 1537 strain, in the first experiment only. No noteworthy toxicity (decrease in the number of revertants or thinning of the bacterial lawn) was noted towards the other strains used, in any experiments. Increases in the number of revertants were noted in the TA 1535 strain in the first and second experiments. These increases exceeded the threshold of 3-fold the vehicle control (up to 3.2-fold and 6.7-fold the vehicle control in the first and second experiments, respectively). Even if they were not dose-related, the increases observed in the first assay were reproduced in the second experiment performed under the pre-incubation method. Moreover, the corresponding means and individual revertant colony counts were above the historical data range of the vehicle control. Consequently, these increases were considered to be biologically significant. Using the direct plate incorporation method (first experiment), increases in the number of revertants were noted in the TA 100 strain at dose-levels = 1250 µg/plate. These increases did not reach the threshold of 2 -fold the vehicle control but the corresponding means and individual revertant colony counts were above the historical data range of the vehicle control.
Increases in the number of revertants were also noted in the second experiment performed using the pre-incubation method. These increases exceeded the threshold of 2-fold the vehicle control at all tested dose-levels (up to 3.7 -fold). Moreover, the corresponding means and individual revertant colony counts were above the historical data range of the vehicle control. Consequently, these increases were considered to be biologically significant. The test item did not induce any other noteworthy or biologically significant increases in the number of revertants in the other tested strains.
The test item showed mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium in the absence and in the presence of a metabolic activation system.
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