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EC number: 205-457-1 | CAS number: 141-10-6
- 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:
- from 1996-09-13 to 1996-09-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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:
- 6,10-dimethylundeca-3,5,9-trien-2-one
- EC Number:
- 205-457-1
- EC Name:
- 6,10-dimethylundeca-3,5,9-trien-2-one
- Cas Number:
- 141-10-6
- Molecular formula:
- C13H20O
- IUPAC Name:
- 6,10-dimethylundeca-3,5,9-trien-2-one
- Details on test material:
- - Name of test material (as cited in study report): Ro 02-2438
- Physical state: clear, yellow liquid
- Analytical purity: 91.2% (Isomer 3+4)
- Lot/batch No.: 05076
- Stability under test conditions: Data regarding stability under test conditions are not available. It is, however, to be expected that no gross degration is occuring when dissolved in the solvent for the test duration (< 6 hours).
- Storage condition of test material: Room temperature
Constituent 1
Method
- Target gene:
- Histidine for Salmonella
Species / strain
- Species / strain / cell type:
- other: TA1535, TA97, TA98, TA100, TA102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment I: 5, 16.6, 50, 166, 500 µg/plate
Experiment II: 5, 16.6, 50, 166, 500 µg/plate
Experiment III: 0.5, 1.6, 5, 16.6, 50 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (Experiment I+II), K22294850 (experiment III)
- Justification for choice of solvent/vehicle: The compound was soluble in dimethylsulfoxide (DMSO).
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: sodium azide (TA1535, TA100), ICR 191 (TA97), 2-nitrofluorene (TA98), MMC (TA102). With and without S9: 2-aminoanthracene (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment I: in agar (plate incorporation)
Experiment II+III: preincubation
DURATION
- Preincubation period: 30 min (Experiment II)
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: determination of the growth of the background lawn and/or frequency of spontaneous revertants - Evaluation criteria:
- There is as yet no generally accepted statistical treatment of Ames test data. In most tests, the results are either clearly positive or clearly negative. A positive result is defined as a reproducible, dose-related increase in the number of his+ revertants. The increase should reach at least a doubling of the number of spontaneous revertants for Salmonella typhimurium strains TA1535 and TA98. For strains TA97, TA100 and TA102 a 1.5 - fold increase over control values might be indicative of a mutagenic effect provided the negative control values fall within the historical control data. Other investigators have set higher limits for a mutagenic response (factor 3 and 2 for the respective groups of strains). These rules of thumb have a questionable scientific foundation and biological relevance should always be taken into account. A negative result is defined as the absence of a reproducible increase in the number of his+ revertant colonies. Since it is impossible to define criteria that would apply to every configuration of data generated by the mutation assay, the study director is responsible for the ultimate decision in the evaluation of the results.
Results and discussion
Test results
- Species / strain:
- other: TA1535, TA97, TA98, TA100, TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The compound was soluble in dimethylsulfoxide (DMSO).
- Precipitation: Upon addition to the aqueous medium, the formation of a milky suspension was observed at 500 µg/plate in the standard plate incorporation assay. Using the preincubation method starting at 166 µg/plate a slight milky suspension with oily precipitation was observable.
RANGE-FINDING/SCREENING STUDIES: For determination of the top dose a preliminary toxicity experiment was performed using strain TA100. Concentrations from 1.6 to 5000 µg/plate were tested. Toxic effects (reduction in the background growth and reduction in the number of revertant colonies) were observed starting at 500 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: The mutant frequencies of the controls were in the range of the historical controls.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Strain dependent toxicity was observed with both methods used. Using the preincubation modification, known to be more sensitive for several classes of compounds, toxicity was more pronounced starting for some strains (-S9) at 50
µg/plate. Therefore a repeat experiment using the preincubation method was performed in the concentration range 0.5 to 50 µg/plate with strains TA1535, and TA102 without S9. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Spontaneous rates
For TA100 the spontaneous rates were at the low range. Nevertheless the experiments were considered acceptable, since the positive controls verified the responsiveness of the cultures used.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Pseudoionone, nor any of the metabolites formed is mutagenic in the Ames test under the used experimental conditions. - Executive summary:
Pseudoionone was evaluated for mutagenic activity in the Ames test in accordance with OECD TG 471. A standard plate incorporation and a preincubation modification assay in absence and in presence of an exogenous metabolic activation system (S9) were performed. Five Salmonella typhimurium tester strains (TA1535, TA97, TA98, TA100, and TA102) were employed. The activity of the S9-mix and the responsiveness of the tester strains were verified by including appropriate controls into each experiment.
Pseudoionone was dissolved in dimethylsulfoxide (DMSO). Toxic effects were observed in a preliminary toxicity experiment, starting at 500 µg/plate (reduction in the number of revertants and reduced background growth). Therefore concentrations ranging from 5 to 500 µg/plate were evaluated in the main experiments. Upon addition to the aqueous medium, a milky suspension was observed at 500 µg/plate (standard assay) and a slight, milky suspension with oily precipitation starting at 166 µg/plate using the preincubation method. Strain dependent toxicity (reduction in the background growth and/or reduction in the number of revertant colonies) was observed in the selected concentration range. The toxic effects were more pronounced in absence of an exogenous metabolic activation system and in the experiment using the preincubation method, known to be more sensitive for several class of compounds. In order to provide data on a sufficient number of test concentrations, a repeat experiment was performed with strains TA1535, and TA102 in absence of S9 using the preincubation method (concentration range: 0.5 to 50 µg/plate).
Pseudoionone did not cause a mutagenic effect in any of the five investigated strains. Thus it can be concluded that neither Pseudoionone per se, nor any of its metabolites formed under the experimental conditions, induced genetic damage in the Ames test.
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