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EC number: 464-300-7 | CAS number: 141645-16-1
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17th November 2004 to 11th December 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to the international guidelines (OECD 471, Commission Directive No. B13/14) and in compliance with the Principles of Good Laboratory Practice Regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 464-300-7
- EC Name:
- -
- Cas Number:
- 141645-16-1
- Molecular formula:
- C19H17NO5
- IUPAC Name:
- 4-(2-butyl-5-nitro-1-benzofuran-3-carbonyl)phenol
- Details on test material:
- Beige powder
Constituent 1
Method
- Target gene:
- Salmonella typhimurium
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Experiments without S9 mix:
The selected treatment-levels were:
• 62.5, 125, 250, 500 and 1000 μg/plate for the TA 102 strain in the first experiment and for the TA 98 strain in both experiments,
• 31.3, 62.5, 125, 250 and 500 μg/plate for the TA 1535 strain in both experiments,
• 15.6, 31.3, 62.5, 125 and 250 μg/plate for the TA 100 strain in the first experiment,
• 7.81, 15.6, 31.3, 62.5 and 125 μg/plate for the TA 1537, TA 100 and TA 102 strains in the second experiment,
• 3.91, 7.81, 15.6, 31.3 and 62.5 μg/plate for the TA 1537 strain in the first experiment.
Experiments with S9 mix:
The selected treatment-levels were:
• 62.5, 125, 250, 500 and 1000 μg/plate for the TA 100 and TA 102 strains in the first experiment and for the TA 98 strain in both experiments,
• 31.3, 62.5, 125, 250 and 500 μg/plate for the TA 1535, TA 1537 and TA 102 strains in the second experiment,
• 15.6, 31.3, 62.5, 125 and 250 μg/plate for the TA 1535 and TA 1537 strains in the first experiment,
• 7.81, 15.6, 31.3, 62.5 and 125 μg/plate for the TA 100 strain in the second experiment. - Vehicle / solvent:
- DMSO
- Details on test system and experimental conditions:
- A preliminary toxicity test was performed to define the dose-levels of SR28043 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 microsomal 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 preincubation 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 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 inthe number of revertant colonies and/or a thinning of the bacterial lawn.
The test item SR28043 was dissolved in dimethylsulfoxide (DMSO).
The dose-levels of the positive controls were as follows:
without S9 mix:
• 1 μg/plate of sodium azide (NaN3): TA 1535 and TA 100 strains,
• 50 μg/plate of 9-Aminoacridine (9AA): TA 1537 strain,
• 0.5 μg/plate of 2-Nitrofluorene (2NF): TA 98 strain,
• 0.5 μg/plate of Mitomycin C (MMC): TA 102 strain.
with S9 mix:
• 2 μg/plate of 2-Anthramine (2AM): TA 1535, TA 1537, TA 98 and TA 100 strains,
• 10 μg/plate of 2-Anthramine (2AM): TA 102 strain.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
Under the experimental conditions, the test item showed a mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium, in
the presence of metabolic activation. - Executive summary:
Under the experimental conditions, the test item showed a mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium, in the presence of metabolic activation.
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