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EC number: 429-100-6 | CAS number: 23911-56-0
- 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:
- 1997-01-28 to 1997-03-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 429-100-6
- EC Name:
- -
- Cas Number:
- 23911-56-0
- Molecular formula:
- C11H10O2
- IUPAC Name:
- 1-(3-methyl-1-benzofuran-2-yl)ethan-1-one
Constituent 1
Method
- Target gene:
- The Salmonella typhimurium histidine (his) reversion system measures his- → his+ reversions. The Salmonella typhimurium strains are constructed to differentiate between base pair (TA1535, TA100) and frameshift (TA1537, TA98, TA 1538) mutations.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- Source of S9: Organon Teknika Corporation, Durham, USA and from ICN Biomedicals GmbH (both from Sprague-Dawley male rats (8-10 weeks old) induced with Aroclor 1254 (500 mg/kg body weight))
- Method of preparation of S9 mix: For 1 mL of S9 mix preparation, 0.1 mL of S9 was mixed with S9 cofactor solution (0.335 mL distilled water, 0.5 mL 0.2 M phosphate buffer, 0.04 mL 0.1 M NADP, 0.005 mL 1 M glucose-6-phosphate and 0.02 mL 0.4 M/1.65 M MgCl2/KCl.
- Concentration or volume of S9 mix and S9 in the final culture medium: 0.5 mL of S9 mix (containing 0.05 mL of S9) in 2.7 mL final culture medium
- Quality controls of S9: Enzymatic activity (tested by benzo(a)pyrene and 2-aminoanthracene induced mutagenesis with tester strains TA98 and TA100), sterility controls - Test concentrations with justification for top dose:
- The test item was tested in concentrations ranging between 5 and 5000 µg/plate in the presence and absence of metabolic activation. The top concentration was chosen according to the applicable guidelines and on the basis of the results of a previous range finding test.
- Vehicle / solvent:
- - Vehicles used: DMSO (test item, 2-aminoanthracene, 2-nitrofluorene) and distilled water (9-aminoacridine, sodium azide)
- Justification for choice of solvent/vehicle: The test item showed good solubility in DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Remarks:
- Without S9: NaN3: 0.5 µg/plate (TA 1535, TA100) 2-AA: 50 µg/plate (TA 1537) 2-NF: 2.5 µg/plate (TA 1538, TA98) With S9: 2-AA: 1 µg/plate (TA 1538, TA98, TA100) 2-AA: 3 µg/plate (TA 1535, TA1537)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: Triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Test method: Plate incorporation
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 hours
METHODS FOR MEASUREMENT OF CYTOTOXICITY
Inhibition of background lawn
METHODS FOR MEASUREMENTS OF GENOTOXICIY
Number of revertant colonies - Rationale for test conditions:
- The number of cultures and the top concentration of 5000 µg/plate were chosen according to the recommendation of the applicable guidelines and on the basis of the results of an initial toxicity test.
- Evaluation criteria:
- Not specified
- Statistics:
- The X2-test was used to estimate statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- STUDY RESULTS
- Concurrent vehicle negative and positive control data: See "Attached background material"
Ames test:
- Signs of toxicity: In the presence of S9, the test item was bacteriotoxic at 1500 µg/plate towards all tester strains. In the absence of S9, the test item was bacteriotoxic at 500 µg/plate towards strains TA1535 and TA98 and at 1500 µg/plate towards strains TA1537, TA1538, and TA100.
- Individual plate counts: See "Attached background material"
- Mean number of revertant colonies per plate and standard deviation: See "Attached background material"
HISTORICAL CONTROL DATA
- Positive historical control data: Not provided.
- Negative (solvent/vehicle) historical control data: Not provided. The laboratory stated that the number of spontaneous revertants observed using each of the five strains was very close to those previously established historical rate and was within the range obtained by Ames et al. (1975) as well as reported by De Serres and Shelby (1979).
Applicant's summary and conclusion
- Conclusions:
- In a bacterial reverse mutation assay according to OECD guideline 471, results indicated that the test item under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98, and TA100 in the presence and absence of a metabolizing system.
- Executive summary:
The mutagenicity of the test item was tested in a GLP compliant study according to OECD guideline 471. Five mutant strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA98, and TA100) were used. The investigations were carried out using the standard plate incorporation assay with and without liver homogenate (S9) from Aroclor 1254 pretreated male rats as metabolic activation system. The test item was dissolved DMSO and tested in concentrations of 5 to 5000 µg per plate in the presence and absence of S9. In the presence of S9, the test item was bacteriotoxic at 1500 μg/plate towards all tester strains. In the absence of S9, the test item was bacteriotoxic at 500 µg/plate towards strains TA1535 and TA98 and at 1500 pg/plate towards strains TA1537, TA1538, and TA100. Sodium azide, 2-nitrofluorene, 9-aminoacridine, and 2-aminoanthracene served as positive controls to confirm the reversion properties and the specificity of the bacterial strains as well as the efficacy of the metabolizing system. In the concentration range investigated, the test item did not induce a significant increase in the spontaneous mutation frequency in any of the tester strains in the absence and presence of a metabolic activation system.
In conclusion, these results indicate that the test item under the experimental conditions described, was not mutagenic to Salmonella typhimuri-um strains TA1535, TA1537, TA1538, TA98, and TA100 in the presence and absence of a metabolizing system.
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