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EC number: 482-330-9 | CAS number: 144020-22-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 482-330-9
- EC Name:
- -
- Cas Number:
- 144020-22-4
- Molecular formula:
- C17H26O
- IUPAC Name:
- 1-[(1E,5Z,9Z)-2,5,10-trimethylcyclododeca-1,5,9-trien-1-yl]ethan-1-one; 1-[(1R)-2,5,10-trimethylcyclododeca-2,5,9-trien-1-yl]ethan-1-one; 1-[(1R)-4,9-dimethyl-12-methylidenecyclododeca-4,8-dien-1-yl]ethan-1-one; 1-[(1S)-2,5,10-trimethylcyclododeca-2,5,9-trien-1-yl]ethan-1-one; 1-[(1S)-4,9-dimethyl-12-methylidenecyclododeca-4,8-dien-1-yl]ethan-1-one
Constituent 1
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: hisG46 rfa Δ uvrB
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- other: hisC3076 rfa Δ uvrB
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052 rfa Δ uvrB pKM101
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46 rfa Δ uvrB pKM101
- Species / strain / cell type:
- E. coli WP2 uvr A
- Remarks:
- (pKM101)
- Additional strain / cell type characteristics:
- other: trpE ochre uvrA pKM101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction, prepared from male Sprague-Dawley derived rats, dosed with phenobarbital and 5,6-benzoflavone to stimulate mixed-function oxidases in the liver, was purchased from a commercial source (Lot No.: 2100, Date of preparation: 10 January 2007) and stored at ca -80°C. Quality controls of S9 were: Biochemistry: protein and alkoxyresorufin-0-dealkylase activities (BROD, EROD, MROD, PROD) and Bioassay: Test for presence of adventitious agents and Promutagen activation. 0.5 mL S9 mix was added to the test substance solutions. The S9 mix contained: S9 fraction (10% v/v), MgCl2 (8 mM), KCl (33 mM), sodium phosphate buffer pH 7.4 (100 mM), glucose-6-phosphate (5 mM), NADPH (4 mM) and NADH (4 mM) in water. All the cofactors were sterilised before use.
- Test concentrations with justification for top dose:
- The highest concentration tested in this study was 50 mg/mL in the chosen vehicle, which provided a final concentration of 5000 µg/plate. This is the standard limit concentration recommended in the regulatory guidelines that this assay follows. The highest concentration in each test was diluted with DMSO to produce a series of lower concentrations, separated by ca half-log10 intervals.
- Vehicle / solvent:
- The Sponsor indicated that Trimofix O was insoluble in water. Its solubility was assessed at 50 mg/mL in dimethyl sulphoxide (DMSO) in which it was found to be soluble. DMSO (A.C.S. pectrophotometric grade) was, therefore, used as the vehicle for this study.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment 1: Plate incorporation methodology
Experiment 2: Pre-incubation methodology
DURATION
- Preincubation period: with and without S9-mix 30 minutes (prior to exposure in experiment 2 only)
- Exposure duration: ca 72 hours (experiment 1 and 2)
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: Background bacterial lawn measurement and reduction in revertant colonies compared to the controls - Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested.
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- No evidence of mutagenic activity in this bacterial system
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- No evidence of toxicity was noted at any of the test concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- No evidence of mutagenic activity in this bacterial system
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- No evidence of toxicity was noted at any of the test concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- No evidence of mutagenic activity in this bacterial system
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- No evidence of toxicity was noted at any of the test concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- No evidence of mutagenic activity in this bacterial system
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- No evidence of toxicity was noted at any of the test concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- No evidence of mutagenic activity in this bacterial system
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- No evidence of toxicity was noted at any of the test concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - The absence of colonies on sterility check plates confirmed the absence of microbial contamination of the S9 mix, buffer and test substance formulation.
- The total colony counts on nutrient agar plates confirmed the viability and high cell density of the cultures of the individual organisms.
- The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations.
- No signs of toxicity were observed towards the tester strains in either mutation test following exposure to Trimofix O.
- Mean number of revertant colonies per plate and standard deviation: The mean revertant colony counts for the vehicle controls were within or close to the 99% confidence limits of the current historical control range of the laboratory.
HISTORICAL CONTROL DATA
- Positive historical control data: available
- Negative (solvent/vehicle) historical control data: available
Any other information on results incl. tables
The absence of colonies on sterility check plates confirmed the absence of microbial contamination of the S9 mix, buffer and test substance formulation. The total colony counts on nutrient agar plates confirmed the viability and high cell density of the cultures of the individual organisms. The mean revertant colony counts for the vehicle controls were within or close to the 99% confidence limits of the current historical control range of the laboratory. Appropriate positive control chemicals (with S9 mix where required) induced substantial increases in revertant colony numbers with all strains in all reported tests, confirming sensitivity of the cultures and activity of the S9 mix.
FIRST TEST: No evidence of toxicity was obtained following exposure to Trimofix O. A maximum exposure concentration of 5000 Fg/plate was, therefore, selected for use in the second test. No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to Trimofix O at any concentration up to 5000 Fg/plate in either the presence or absence of S9 mix.
SECOND TEST; No evidence of toxicity was obtained following exposure to Trimofix O. No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to Trimofix O at any concentration up to 5000 Fg/plate in either the presence or absence of S9 mix.
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium and Escherichia coli reverse mutation assay performed according to OECD TG 471.
- Executive summary:
The substance is tested in the Ames test in accordance with OECD TG 471 and GLP. Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and a tryptophan-dependent mutant of Escherichia coli, strain WP2 uvrA (pKM101), were treated with the test item using both the Ames plate incorporation and pre-incubation methods at up to seven dose levels, in triplicate, both with and without the addition of S9-mix. Based on results of experiment 1 (plate incorporation), the dose range used for experiment 2 (pre-incubation method) was between 5 to 5000 μg/plate. No evidence of mutagenic activity was seen at any concentration of the substance in either mutation test. Adequate negative and positive controls were included. The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) for both experiments. Based on the results, the substance is not mutagenic in this test.
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