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EC number: 953-102-0 | 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:
- 19th March 2020 to 24th March 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N'-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]BENZOHYDRAZIDE
- Cas Number:
- 1453473-00-1
- IUPAC Name:
- N'-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]BENZOHYDRAZIDE
- Test material form:
- solid: particulate/powder
1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- 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:
- Lot No 19092707 and were prepared from 7 week old male Sprague Dawley rats that had been injected intraperitoneally with Phenobarbitol (PB) and 5,6-benzoflavone (BF). PB was injected intraperitoneally 4 times (Day 1: 30 mg/kg body weight & Day 2-4:30 mg/kg body weight). BF was injected intraperitoneally once on Day 3 (80 mg/kg body weight). The S9 was stored at -80 oC
- method of preparation of S9 mix: S9-mix was prepared immediately before use and kept on an ice bath until use. S9-mix contained per 1 mL: MgCl2 8μmol, KCL 33μmol, 4μmol NADH, 5μmol NADPH, 5μmol glucose-6-phosphate in 100μmol sodium phosphate buffer pH 7.4; - Test concentrations with justification for top dose:
- Selection of an adequate range of doses was based on a dose-determination test. Eight concentrations, 0.305, 1.22, 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate were tested. The number of revertant colonies were counted. Cytotoxicty to bacteria by the test substance and precipitation of the test substance were examined. The highest concentration of the test item used in the subsequent mutation assays was 5000 µg/plate. Six dose levels separated by a factor of 2 were used for the mutagenicity test.
- Vehicle / solvent:
- DMSO = dimethyl sulfoxide
Lot No. 009H1642
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other:
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: duplicate
- Number of independent experiments: two
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding: ~ 10 9 cells/mL
- Test substance added in top agar tubes
The test substance solution (0.1ml) was dispensed into a test tube followed by either 0.5 mL S9-mix (in the presence of metabolic activation) or 0.1 M phosphate buffer (in the absence of metabolic activation) and 0.1ml of each bacterial culture. The contents of each test tube was pre-incubated at 37oC for 20mins with shaking, mixed with 2.0ml of the top agar and evenly distributed onto the surface of minimal agar plates. The plates were incubated for 48 hours.
After this period, all plates were assessed for the numbers of revertant colonies and were observed for the presence or absence of cytotoxicty to bacteria by the test substance under a stereomicroscope. - Evaluation criteria:
- When the test substance induces a dose-dependent increase in the number of revertant colonies to at least twice as many as that of the negative control and the increase is reproducible, the test substance is judged positive in this test system.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- 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
- Untreated negative controls validity:
- valid
- 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
- Untreated negative controls validity:
- valid
- 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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test substance was concluded to be non-mutagenic.
- Executive summary:
This test was designed to assess the mutagenic potential of N'-(1,1,1-trifluoropropan-2-ylidene)benzohydrazide using a bacterial reverse mutation test system using Salmonella typhimurium strains TA100, TA1535, TA98 and TA1537 and Escherichia coli WP2uvrA. Throughout the tests N'-(1,1,1-trifluoropropan-2-ylidene)benzohydrazide did not induce any increases in the number of revertant colonies to at least twice as many as that of the negative control for any of the bacterial strains.
The test substance was concluded to be non-mutagenic under the conditions of the test.
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