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EC number: - | CAS number: -
- 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:
- 25 NOV 2020 - 08 FEB 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Guidelines for Studies Chemicals, Chapter 5 Health impact test field, Section 22 Genotoxicity (Bacterial Reverse Mutation Test)
- Version / remarks:
- Notification No. 2020-46, National Institute of Environmental Research, Republic of Korea (Nov. 3,
2020) - Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted on Jul. 21, 1997, corrected on Jun. 26, 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- bis(2,2,6,6-tetramethyl-1-(1,3-benzothiazol-2-ylsulfanyl)piperidin-4-yl)carbonate
- Cas Number:
- 2311845-49-3
- Molecular formula:
- C33H42N4O3S4
- IUPAC Name:
- bis(2,2,6,6-tetramethyl-1-(1,3-benzothiazol-2-ylsulfanyl)piperidin-4-yl)carbonate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- his and trp (please refer to any other information on materials and methods incl. tables)
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Remarks:
- pKM101
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Male rat, Sprague Dawley, Molecular Toxicology, Inc.
- method of preparation of S9 mix: S9 Mix was prepared by mixing the S9 fraction and S9 cofactor (cofactor I) with S9 fraction of 5 %. The prepared S9 Mix was kept cool condition before treatment. S9 Mix was treated with 0.5 mL/plate. Enzyme activity was confirmed by mutagenesis of 2AA and B[a]P.
- concentration or volume of S9 mix and S9 in the final culture medium: final concentration 5% - Test concentrations with justification for top dose:
- 5.1, 15.4, 46.3, 138.9, 416.7, 1250 μg/plate
Based on results in the concentration range finding study, highest concentration in the main study was set 1250 μg/plate in all strains both in the presence and absence of the metabolic activation system. It was serially diluted to consist of six concentration levels by the common ratio of 3. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: This vehicle has no toxic effect on the test systems and the metabolic activation system. Also results of vehicle test, when test substance was
prepared in sterile distilled water, precipitation was observed. In case of DMSO, test substance was suspended. However, no precipitation was observed. Therefore, the vehicle was chosen as DMSO.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-Aminoanthracene (2AA), N-Methyl-N’-nitro-Nnitrosoguanidine (MNNG)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 2 (main study, confirmatory study)
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation): 0.5 mL of S9 Mix, 0.1 mL of the test substances and 0.1 mL of bacterial culture were added in a sterile test tube. In case of absence of metabolic activation system, 0.5 mL of 0.2 M Sodium Phosphate Buffer (pH 7.4) was added instead of S9 Mix. The negative control group was treated with 0.1 mL of vehicle.
And, the positive control group was treated with 0.1 mL of positive control substance. Each prepared tube was added 2 mL of top agar and mixed evenly using vortex mixer. After mixed, poured into a minimal nutrient plate medium (MNA) and applied evenly.
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: After treatment was finished, turned the plate upside down and incubated above 48 hours in a 37 °C incubator.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: Each plate was observed on the basis of the background lawn pattern of the negative control group using a stereomicroscope, and the thickness and colony pattern of the background lawn are closely observed and used as a cytotoxicity index of the test substance
METHODS FOR MEASUREMENTS OF GENOTOXICIY
After incubated, number of revertant in the plates were counted using an oil pen.
The average and standard deviation of the number of revertant obtained from the plate of each concentration group and the number of revertant were expressed with integers. - Rationale for test conditions:
- In order to confirm the reproducibility of the main study, a confirmatory study was performed using the same concentrations and method as in the main study.
- Evaluation criteria:
- If the test substance met the following criteria, it was judged to be negative.
- When the mean number of colonies in the test substance-treated group did not show a
concentration-dependent increase and was less than 2 times the number of negative control
colonies.
If the test substance was met all the following criteria, it was judged as positive.
Regardless of the application of the metabolic activation system to the test substance exposure, the test substance was judged to induce a return mutation in the bacteria when the following results were obtained in at least one strain. At this time, the biological relevance was considered.
- When the mean number of colonies in the test substance-treated group will be shown a
concentration-dependent increase and will be more than twice as large as the number of colonies
in the negative control group.
- When the mean number of colonies in the treatment of the test substance is 2.0 times higher than the number of colonies in the negative control group, and when reproducibility is observed as a result of the confirmation test.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- pKM101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- with: 2-Aminoanthracene without: N-Methyl-N-nitro-N-nitrosoguanidine
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- with: 2-Aminoanthracene without: 9-Aminoacridine
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- with: 2-Aminoanthracene without: Sodium azide
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- with: 2-Aminoanthracene without: Sodium azide
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- with: Benzo[a]pyrene without: 2-Nitrofluorene
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES (if applicable):
In this study, turbidity was observed at 313, 1250 and 5000 μg/plate in the treatment mixture. When colony counting, precipitation was observed at 313, 1250 and 5000 μg/plate in the plates. Count of colony at 5000 µg/plate was impossible due to precipitation of test substance.
Thin background lawn and reduction of colony determining cytotoxicity were not observed. The background lawn was in normal condition. There were no increases in mean number of revertants at all concentrations in all strains both in the presence and absence of the metabolic activation system. Therefore, the highest concentration in the main test was set to 1250 μg/plate, including the concentration at which precipitation of the test substance was observed, excluding the concentration at which counting was impossible.
STUDY RESULTS
- Concurrent vehicle negative and positive control data: see attached tables
Ames test:
- Signs of toxicity: There were no increases in mean number of revertants at all concentrations in all strains both in the presence and absence of the metabolic activation system.
- Mean number of revertant colonies per plate and standard deviation: see attached tables
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data):
The mean number of revertant in the negative and positive control group was evaluated to be within the range of historical control data, see attached tables
Applicant's summary and conclusion
- Conclusions:
- All validity criteria of this test were fulfilled. No increases in mean number of revertant were observed at all concentrations in all strains both in the presence and absence of the metabolic activation system. In the positive control group, the number of revertant increased more than twice compared to the negative control group. In conclusion, the test substance was considered as not having reverse mutagenic potential on bacterial strains of S. typhimurium and E. coli under the present study conditions.
- Executive summary:
The bacterial reverse mutation test was performed according to OECD guideline 471 under GLP compliance. This study was conducted in order to evaluate the mutagenic potential of the test substance in the Bacterial Reverse Mutation Test using Salmonella typhimurium strains (S. typhimurium TA98, TA100, TA1535 and TA 1537) and Escherichia coli strain (E. coli WP2 uvrA) in the presence and absence of an exogenous
metabolic activation system (S9 mix).A concentration range finding study was conducted to determine the concentration of the test substance prior to the main study. The confirmatory study was conducted to confirm the reproducibility of the results of the main study.
The highest concentration of the test substance in the concentration range finding study was selected as 5000 μg/plate and serially diluted to consist of six concentration levels by the common ratio of 4.
In the concentration range finding study, precipitation was observed at 313, 1250 and 5000 μg/plate. Count of revertant at 5000 μg/plate was impossible due to heavy precipitation of the test substance. There were no cytotoxicity and no increases in mean number of revertants at all concentrations in all strains both in the presence and absence of the metabolic activation system.According to results of concentration range finding study, the highest concentration in the main study and confirmatory study was selected as 1250 μg/plate and serially diluted to consist of six concentration levels by the common ratio of 3. In the main and confirmatory study, precipitation was observed at 416.7 and 1250 μg/plate. There were no cytotoxicity and no increases in mean number of revertants at all concentrations in all strains both in the presence and absence of the metabolic activation system.
In the positive control group, increases of mean number of revertant was observed more than twice compared to the negative control group. All validity criteria of this test were fulfilled.In conclusion, the test substance was considered as not having reverse mutagenic potential on bacterial strains of S. typhimurium and E. coli under the present study conditions.
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