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EC number: 277-146-9 | CAS number: 72968-71-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- The ability of MACROLEX Rot B to induce mutations was investigated using Salmonella typhimurium strains TA 100, TA1535, TA98 and TA1537 and Escherichia coli strain WP2uvrA with a pre-incubation method in the absence and presence of a metabolic activation System (S9 mix).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate
- EC Number:
- 277-146-9
- EC Name:
- Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate
- Cas Number:
- 72968-71-9
- Molecular formula:
- C23H29N7O4S
- IUPAC Name:
- methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Chemical name. Methyl 4-cyano-5 [[5-cyano-2,6-bis[(3-methoxy propyl)amino]-4-methyl-3-pyridyl azo]-3-methyl-2-thenoate
Other name: MACROLEX Rot B
CAS Number: 72968-71-9
Purity: >99% (w/w)
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- Negative control, 0.305, 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-FuryI)-3-(5-nitro-2 furyl)acrylamide, Sodium azide, 2-Aminoanthracene
- Details on test system and experimental conditions:
- This study was performed by the pre-incubation method without and with S9 mix. Triplicate plates were used for the negative control group, and duplicate plates were used for the positive control and the test substance treatment groups.
Procedures
After 0.1 mL of the test substance solution, vehicle or the positive control substance solution, 0.5 mL of 0.1 M sodium phosphate bufier (pH 7.4) or S9 mix and 0.1 mL of the bacterial culture were added to a test tube, the mixture as shaken at 37±0.5°C for 20 minutes. Two milliliters of the soft agar were then added to each tube and the mixture was poured onto a minimal glucose agar plate. The number of revertant colonies was counted after incubation at 37±0.5°C for 48 hours.
Confirmation of Sterility
The highest concentration of the test substance solution (0.1 mL) and S9 mix (0.5 mL) were individually mixed with 2 mL of the soft agar and were poured onto the minimal glucose agar plate in order to examine bacterial contamination.
Bacterial contamination was judged with those plates after incubation at 37±0.5°C for 48 hours.
Negative Control and Positive Controls
The vehicle was employed as a negative control. As positive controls 2-(2-FuryI)-3-(5-nitro-2 furyl)acrylamide, Sodium azide, 2-Aminoanthracene were used. - Evaluation criteria:
- The test substance was judged to be positive when the number of revertant colonies increased to twice or more than that in the negative control and when the responses were dose-related and/or reproducible. The other cases were judged to be negative. No statistical methods were used.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The mutagenicity of the test substance was judged to be negative because the number of the revertant colonies in the test substance treatment groups in all tester strains was less than twice that in the negative control without and with S9 mix.
The numbers of the revertant colonies in the positive controls were above twice that in the negative controls, The test results showed that the numbers of revertant colonies in the negative control and the positive controls were within the range of the historical data at the testing facility. It was also confirmed that no bacterial contamination was observed, which indicates the test results to be valid.
Applicant's summary and conclusion
- Conclusions:
- It was concluded that MACROLEX Rot B did not induce mutations under the present test conditions.
- Executive summary:
The ability of MACROLEX Rot B to induce mutations was investigated using Salmonella typhimurium strains TA 100, TA1535, TA98 and TA1537 and Escherichia coli strain WP2uvrA with a pre-incubation method in the absence and presence of a metabolic activation System (S9 mix).
As a result, the mutagenicity of the test substance was judged to be negative because the numbers of revertant colonies in the test substance treatment groups were less than two times that in each negative control in all testet strains with and without S9 mix.
Consequently, it was concluded that MACROLEX Rot B had no ability to induce mutations under the present test conditions.
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