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EC number: 922-963-4 | CAS number: -
- 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:
- 2010-09-29 and 2010-11-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-conform and according to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of trans-5-hexyldihydro-4-methylfuran-2(3H)-one and cis-5-hexyldihydro-4-methylfuran-2(3H)-one
- EC Number:
- 922-963-4
- Molecular formula:
- C11H20O2
- IUPAC Name:
- Reaction mass of trans-5-hexyldihydro-4-methylfuran-2(3H)-one and cis-5-hexyldihydro-4-methylfuran-2(3H)-one
Constituent 1
Method
- Target gene:
- Salmonella typhimurium: histidine operon
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:
- Phenobarbital/b-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- - Pre-Experiment and Experiment I (plate incorporation test) : 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
- Experiment II (pre-incubation test): 1; 3; 10; 33; 100; 333; 1000; and 2500 µg/plate - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: - S9: sodium azide (TA1535, TA100), 4-nitro-o-phenylene-diamine (TA1537, TA98), methyl methane sulfonate (WP2 uvrA); + S9: 2-aminoanthracene (TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes (pre-incuabtion method)
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn - Evaluation criteria:
- - A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
- A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
- An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
- A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
Results and discussion
Test results
- Species / strain:
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test item precipitated in the overlay agar in the test tubes from 2500 µg/plate up to 5000 µg/plate in the presence of metabolic activation. Precipitation on the incubated agar plates was observed from 1000 µg/plate up to 5000 µg/plate in the presence of metabolic activation in experiment I.
RANGE-FINDING/SCREENING STUDIES: In the pre-experiment the concentration range of the test item was 3 – 5000 µg/plate. The following concentrations were used in the main study: 1; 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
COMPARISON WITH HISTORICAL CONTROL DATA: Yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: see "any other information on results" - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The plates incubated with the test item showed reduced background growth at the following concentrations (µg/plate):
Strain |
Experiment I |
Experiment II |
||
|
Without S9 |
With S9 |
Without S9 |
With S9 |
TA 1535 |
1000 - 5000 |
/ |
333 - 2500 |
1000 - 2500 |
TA 1537 |
333 - 5000 |
1000 - 5000 |
333 - 2500 |
1000 - 2500 |
TA 98 |
333 - 5000 |
/ |
100 - 2500 |
1000 - 2500 |
TA 100 |
333 - 5000 |
/ |
333 - 2500 |
1000 - 2500 |
WP2 uvrA |
333 - 5000 |
/ |
1000 - 2500 |
1000 - 2500 |
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups at the following concentrations (µg/plate):
Strain |
Experiment I |
Experiment II |
||
|
Without S9 |
With S9 |
Without S9 |
With S9 |
TA 1535 |
1000 - 5000 |
1000 - 5000 |
333 - 2500 |
1000 - 2500 |
TA 1537 |
333 - 5000 |
1000 - 5000 |
333 - 2500 |
1000 - 2500 |
TA 98 |
/* |
2500 - 5000 |
100 - 2500 |
1000 - 2500 |
TA 100 |
2500 - 5000 |
2500 - 5000 |
1000 - 2500 |
1000 - 2500 |
WP2 uvrA |
1000 - 5000 |
1000 - 5000 |
1000 - 2500 |
1000 - 2500 |
/* = no analysis possible at 5000 µg/plate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
This study was performed to investigate the potential of the test substance to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA with an without liver microsomal activation. The test item was tested at the following concentrations: 3, 10, 33, 100, 333, 1000, 2500, and 5000 µg/plate (pre-experiment/experiment I); 1, 3, 10, 33, 100, 333, 1000, and 2500 µg/plate (experiment II). Reduced background growth in the test groups with and without metabolic activation in both independent experiments was observed at higher concentrations. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Peacholide at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. In conclusion, these results indicated that the test substance under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains and Escherichia coli in the absence and presence of a metabolizing system.
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