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EC number: 913-400-3 | 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:
- 07 April 2014 - 22 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of [(3,7-dimethyloct-6-en-1-yl)oxy]acetaldehyde and [(3,7-dimethyloctyl)oxy]acetaldehyde
- EC Number:
- 913-400-3
- Molecular formula:
- C12H22O2
- IUPAC Name:
- Reaction mass of [(3,7-dimethyloct-6-en-1-yl)oxy]acetaldehyde and [(3,7-dimethyloctyl)oxy]acetaldehyde
- Test material form:
- liquid
- Details on test material:
- Storage condition of test material: PURGE HEADSPACE WITH NITROGEN, REFRIGERATE (35 - 46.5 F / 2 - 8 C)
1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced with Aroclor 1254
- Test concentrations with justification for top dose:
- - Experiment 1, initial test:
TA 1535, TA 1537, TA 98, TA 100 and WP2uvrA (without and with S9): 5, 16, 50, 160, 500, 1600 and 5000 µg/plate
- Experiment 2, confirmatory test:
TA 1535, TA 1537, TA 98, TA 100 and WP2uvrA (with S9): 5, 16, 50, 160, 500, 1600 and 5000 µg/plate
TA 1535, TA 1537, TA 98, TA 100 and WP2uvrA (without S9): 5, 16, 50, 160, 500 and 1600 µg/plate
Repeat confirmatory test:
TA 1537 (with and without S9): 5, 16, 50, 160, 500 and 1600 µg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: The formulation at 50 mg/mL formed a non-viscous, transparent, colorless solution and remained freely soluble at all succeeding lower dilutions prepared for this assay.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: See remarks
- Remarks:
- For further information on positive controls see Any other information on materials and methods incl. tables.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Experiment 1 and 2: in agar (plate incorporation)
DURATION
- Exposure duration: 52 ± 4 hours at 37 ± 2°C.
NUMBER OF REPLICATIONS:
- All doses of the test article, as well as the concurrent positive and vehicle controls were evaluated in triplicate plates.
DETERMINATION OF CYTOTOXICITY
- Method: on the basis of a decline in the number of revertants and/or a thinning of the background lawn. - Evaluation criteria:
- Criteria for a Positive Response:
A test article is considered to have produced a positive response if it induces a dose dependent increase in revertant frequency that is ≥ 2.0-fold vehicle control values for tester strains TA98, TA100, and WP2uvrA, or ≥ 3.0-fold vehicle control values for tester strains TA1535 and TA1537. In addition, any response should be reproducible.
Criteria for a Negative Response:
A test article is considered to have produced a negative response if no dose-dependent, ≥ 2.0-fold or ≥ 3.0-fold increases are observed in tester strains TA98, TA100, and WP2uvrA, or TA1535 and TA1537, respectively.
Criteria for an Equivocal Response:
Even after repeated trials, a test article may produce results that are neither clearly positive nor clearly negative (e.g., responses that do not meet the dose-dependency or fold increase requirements but are reproducible). In those rare instances, the test article may be considered to have produced an equivocal response.
Other criteria also may be used in reaching a conclusion about the study results (e.g., comparison to historical control values, biological significance, etc.). In such cases, the Study Director will use sound scientific judgment and clearly report and describe any such considerations.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 1600 μg/plate with S9, ≥ 500 μg/plate without S9, in both experiments
- Vehicle controls validity:
- valid
- 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
- Remarks:
- ≥ 1600 μg/plate with S9, ≥ 500 μg/plate without S9, in both experiments
- Vehicle controls validity:
- valid
- 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
- Remarks:
- ≥ 1600 μg/plate with S9, ≥ 500 μg/plate without S9, in both experiments
- Vehicle controls validity:
- valid
- 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
- Remarks:
- ≥ 1600 μg/plate with S9, ≥ 500 μg/plate without S9, in both experiments
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 μg/plate with S9 in experiment 1, ≥ 1600 μg/plate without S9 in experiment 1 and with S9 in experiment 2, ≥ 500 μg/plate without S9 in experiment 2.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitate was observed at any tested dose level in the presence or absence of S9.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Although very slightly outside the historical control data range, the solvent control in strain TA 100 tested with S9 in the second experiment was within the acceptance limits reported in this study, and therefore this control is also considered valid.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Experiment 1:
Toxicity, as evident by the absence or reduction in the mean number of revertant colonies, and/or absence or reduction of the bacterial background lawn, was observed at ≥1600 μg/plate in the presence of S9 in all tester strains except WP2uvrA, where toxicity was observed at 5000 μg/plate. In the absence of S9, toxicity was observed at ≥500 μg/plate in all tester strains except WP2uvrA, where toxicity observed at ≥1600 μg/plate.
- Experiment 2:
Toxicity, as evident by the absence or reduction in the mean number of revertant colonies, and/or absence or reduction of the bacterial background lawn, was observed in all tester strains at ≥1600 μg/plate in the presence of S9 and ≥500 μg/plate in the absence of S9. Enhanced bacterial background lawn was observed in TA1537 in the presence and absence of S9 at all tested concentrations including the vehicle control.
- Experiment 2, repeat TA 1537:
Toxicity, as evident by the absence or reduction in the mean number of revertant colonies, and/or absence or reduction of the bacterial background lawn, was observed at 1600 μg/plate in the presence of S9 and at ≥500 μg/plate in the absence of S9.
Additional information on Revertant colonies:
No increase in the mean number of revertant colonies was observed at any tested dose level in any tester strain in the presence or absence of S9 in the first experiment or the second and repeated second experiment.
Applicant's summary and conclusion
- Conclusions:
- The substance is negative in the Salmonella typhimurium reverse mutation assay and Escherichia coli reverse mutation assay performed according to OECD 471 guideline and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 guideline and according to GLP principles. The test was performed in two independent plate incorporation experiments. The test substance was tested at doses of 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 μg/plate, in the absence and presence of S9-mix in the first experiment. Based on the results of the first test an independent confirmatory experiment was performed with doses up to 5000 μg/plate in the presence of S9 and up to 1600 μg/plate in the absence of S9. Toxicity was observed at ≥1600 μg/plate in the presence of S9 and in the absence of S9 at ≥500 μg/plate in all tester strains in all experiments. Except for experiment 1 where toxicity was observed in WP2uvrA at 5000 μg/plate in the presence of S9 and at ≥1600 μg/plate in the absence of S9. Adequate negative and positive controls were included. The substance did not induce a significant dose related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in E.coli WP2uvrA, both in the absence and presence of S9-metabolic activation in both experiments. Based on the results of this study it is concluded that the substance is negative in the Salmonella typhimurium reverse mutation assay and negative in the Escherichia coli reverse mutation assay.
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