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EC number: 941-461-6 | CAS number: 1231930-42-9
- 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:
- 16 Janauary 2009 to 21 January 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- - Parameters analysed / observed: Two strain mutagenicity assay
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6-(2-chloro-5-fluoropyrimidin-4-yl)-4-fluoro-2-methyl-1-(propan-2-yl)-1H-1,3-benzodiazole
- EC Number:
- 941-461-6
- Cas Number:
- 1231930-42-9
- Molecular formula:
- C15H13CIF2N4
- IUPAC Name:
- 6-(2-chloro-5-fluoropyrimidin-4-yl)-4-fluoro-2-methyl-1-(propan-2-yl)-1H-1,3-benzodiazole
Constituent 1
- Specific details on test material used for the study:
- - Source and lot/batch No.of test material: PX2-Z00174-169-3- Storage condition of test material: Room temperature in the dark with desiccant- Analytical purity: 100%
Method
- Target gene:
- Mutation of the uvrB gene (Salmonella)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not specified
- Test concentrations with justification for top dose:
- The test material was evaluated in the mutagenicity assay at doses of 1.50, 5.00, 15.0, 50.0, 150, 500, 1500, and 5000 micrograms/plate with and without S9. The maximum dose tested of 5000 micrograms/plate; this dose was achieved using a concentration of 100 mg/mL and a 50 micro/L plating aliquot
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dose formulations of the test material and dimethyl sulfoxide- Justification for choice of solvent/vehicle: The volume of Dimetyl Sulfoxide used has been shown not to effect survival or induce mutations in control cultures
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Tester Strain TA98 with and without S9 activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Tester strain TA100 with and without S9 activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Plate incorporation method - the tester strain, test article, and S9 mix (where appropriate) are combined in molten top agar, which is then overlaid onto a minimal bottom agar plate. Following incubation, revertant colonies are counted.DURATION: Plates are incubated for approximately 48-72 hours at 35-39oCSELECTION AGENT (mutation assays): Bacterial reverse mutation assayNUMBER OF REPLICATIONS: All test and control articles were evaluated in duplicate platesDETERMINATION OF CYTOTOXICITY: The condition of the bacterial background lawn was evaluated for evidence of test article toxicity by using a dissecting microscope
- Rationale for test conditions:
- Tester strain TA98 is reverted from auxotrophy to prototrophy by frameshift mutagens. Tester strain TA100 is reverted by mutagens that cause both frameshift and basepair substitution mutations
- Evaluation criteria:
- Evaluation of Results:For the test material to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentration of test material. Data sets for tester strains TA98 and TA100 were judged postive if the increase in mean revertants at the peak of the dose response was equat to or greater than 2 times the mean vehicle control value. Criteria for a Valid test:All salmonella tester strain cultures must demonstrate the presence of the deep rough mutation (rfa), the deletion in the uvrB gene and the presence of the pKM101 plasmid R-factor. All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls as follows (inclusive): TA98, 10 - 50; TA100, 80 - 240The mean of each postive control must exhibit at least a 3.0 fold increase in the number of revertants over the mean value of the respective vehicle control. A minimum of three dose levels is required to evaluate assay data
Results and discussion
Test resultsopen allclose all
- Key result
- 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 examined
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- These results indicate that LSN2833975 is negative in the Bacterial Reverse Mutation Assay when tested up to toxicity limiting dose levels with and without S9 metabolic activation, and under the conditions of the study protocol used.
- Executive summary:
The objective of this study was to evaluate LSN2833975, for its ability to induce reverse mutations at the histidine locus in Salmonella typhimurium tester strains TA98, TA100.
All criteria for a valid study were met as described in the protocol. The results of the Salmonella Plate Incorporation Mutagenicity Assay indicate that, under the conditions of the study, intermediate LSN2833975 did not cause a positive mutagenic response with either the presence or absence of Aroclor-induced rat liver S9.
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