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EC number: 940-766-1 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-08-03 to 2005-09-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- (1E,5E,9E)-cyclododeca-1,5,9-triene; (1Z,5Z)-cycloocta-1,5-diene; 4-ethenylcyclohex-1-ene
- EC Number:
- 940-766-1
- Molecular formula:
- unspecified
- IUPAC Name:
- (1E,5E,9E)-cyclododeca-1,5,9-triene; (1Z,5Z)-cycloocta-1,5-diene; 4-ethenylcyclohex-1-ene
- Details on test material:
- - Name of test material (as cited in study report): 4-Vinyl-1-cyclohexen (constituent of registered reaction mass)
- Physical state: Liquid, clear colorless
- Analytical purity: 99.8 area-%
- Lot/batch No.: 20140404
Constituent 1
Method
- Target gene:
mutated gene loci responsible for histidine auxotrophy
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: tryptophan auxotroph
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor 1254 induced rat liver S9; male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- Experiment I : 0, 20, 100, 500, 2500, 5000 µg/plate, Standard plate test with and without S-9 mix, 3 test plates per dose or per control
Experiment II: 0, 50, 100, 150, 200, 250 µg/plate, Standard plate test with and without S-9 mix, 3 test plates per dose or per control
Experiment III: 0, 1.25, 2.5, 5, 10, 20 µg/plate, Standard plate test with and without S-9 mix, 3 test plates per dose or per control - Vehicle / solvent:
- DMSO (Dimethyl sulfoxid, CAS No. 67-68-5; purity > 99 %)
Controls
- Untreated negative controls:
- no
- Remarks:
- vehicle will be used as negative reference item
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
with metabolic activation: 2-aminoanthracene, strains: TA 1535, TA 100, TA 1537, TA 98: 2.5 µg/plate, dissolved in DMSO strain: Escherichia coli WP2 uvrA: 60 µg/plate, dissolved in DMSO
- Details on test system and experimental conditions:
- Bacterial Reverse Mutation Test
SYSTEM OF TESTING
- Standard plate test with and without S-9 mix
- Metabolic activation assay: Arochlor 1254 induced rat liver S9, 5 male Sprague-Dawley rats receive single intraperitoneal injection of 500 mg
Arochlor 1254, 5 days before sacrifice
ADMINISTRATION
- Dosing: at least 5 concentrations up to 5000 µg/plate
- Data : 3 independent experiments with and without metabolic activation
Experiment I : 0, 20, 100, 500, 2500, 5000 µg/plate, Standard plate test with and without S-9 mix, 3 test plates per dose or per control
Dose selection and evaluation are based on the findings of the 1st experiment
Experiment II: 0, 50, 100, 150, 200, 250 µg/plate, see above
Experiment III: 0, 1.25, 2.5, 5, 10, 20 µg/plate, see above
- Number of plates: 3 per dose or per control
- Positive and negative control groups and treatment:
- positive without metabolic activation:
strains TA 1535, TA 100: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 5 µg/plate
strain TA 98: 4-nitro-o-phenylendiamine (NOPD), 10 µg/plate
strain TA 1537: 9-aminoacridine (AAC), 100µg/plate
strain E. coli WP2 uvrA: 4-nitroquinoline-N-oxide (4-NQO), 5 µg/plate
- positive with metabolic acivation
strains TA 1535, TA 100, TA 1537, TA 98: 2-aminoanthracene, 2.5 µg/plate, dissolved in DMSO
strain Escherichia coli WP2 uvrA: 2-aminoanthracene, 60 µg/plate, dissolved in DMSO
- negative control: solvent control: DMSO for all strains
- Incubation time: 48 - 72 h at 37 °C in the dark - Evaluation criteria:
Toxicity:
-toxicity detected by decrease in number of revertants, clearing or diminution of the background lawn, reduction of the titer (recorded for all test groups)
Solubility:
-precipitation recorded
Acceptance criteria (experiment is considered valid if following criteria are met:)
- number of revertant colonies in the negative controls was within the normal range of the historical control data for each tester strain
-sterility controls revealed no indication of bacterial contamination
- positive control both with and without S9 mix induced a significant increase in number of revertants within the range of the historical control data or above
- titer of viable bacteria was at least 10 exp8 / ml
Assessment criteria:
-Test is considered positive if a dose related and reproducible increase in number of revertant colonies is observed i.e. about doubling of spontaneous mutation rate in at least one tester strain either without or with metabolic activation.
- The test item is generally considered nonmutagenic in this test if:
The number of revertants for all test strains were within the historical negative control range under all experimental conditions in two independ experiments- Statistics:
- According to the OECD Guideline 471, a statistical analysis of the data is not mandatory; mean number of revertant colonies per plate and standard deviation are determined
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Bacteriotoxic effects was observed depending on the strain and test conditions from about 20 µg - 50 µg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- valid
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Bacteriotoxic effects was observed depending on the strain and test conditions from about 20 µg - 50 µg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- valid
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Bacteriotoxic effects was observed depending on the strain and test conditions from about 20 µg - 50 µg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- valid
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Bacteriotoxic effects was observed depending on the strain and test conditions from about 20 µg - 50 µg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- valid
- Positive controls validity:
- not specified
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Bacteriotoxic effects was observed depending on the strain and test conditions from about 20 µg - 50 µg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negative
According to the test results of the present study, the test substance 4-Vinylcyclohexen is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen here. - Executive summary:
The test substance 4-Vinylcyclohexen was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of serveral bacterial strains, Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli WP2, in a reverse mutation assay. The study was carried out according to OECD method 471 in compliance with the current OECD Principles of Good Laboratory Practice. Dose levels covering a total range of 1.25 µg - 5000 µg/plate, in a standard plate test both with and without the addition of a metabolising system (Arochlor 1254 induced rat liver S9 mix) were employed.
A bacteriotoxic effects was observed depending on the strain and test conditions from about 20 µg - 50 µg/plate onward.
A relevant increase in the number of his + or trp + revertants was not observed either without S-9 mix or after addition of a metabolizing system.
According to the test results of the present study, the test substance 4-Vinylcyclohexen is not mutagenic in the Salmonella typhimurium/Escherichiacoli reverse mutation assay under the experimental conditions chosen here.
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