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EC number: 619-127-3 | CAS number: 95418-58-9
- 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:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-(tert-butoxy)-4-ethenylbenzene
- EC Number:
- 619-127-3
- Cas Number:
- 95418-58-9
- Molecular formula:
- C12H16O
- IUPAC Name:
- 1-(tert-butoxy)-4-ethenylbenzene
- Test material form:
- liquid
- Details on test material:
- Clear and colourless
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: rat liver microsomal enzymes were routinely prepared from adult male Wistar rats, which were obtained from Charles River, Sulzfeld, Germany.
- method of preparation of S9 mix: S9-mix was prepared immediately before use and kept on ice. S9-mix components contained per 10 ml: 30 mg NADP and 15.2 mg glucose-6-phosphate in 5.5 ml or 5.0 ml Milli-Q water (first or second experiment respectively); 2 ml 0.5 M sodium phosphate buffer pH 7.4; 1 ml 0.08 M MgCl2 solution; 1 ml 0.33 M KCl solution.
- concentration or volume of S9 mix and S9 in the final culture medium:
Volume of S9-mix: 10 ml.
Concentration of S9-mix in the first experiment: 5% (v/v).
Concentration of S9-mix in the second experiment: 10% (v/v). - Test concentrations with justification for top dose:
- First experiment: 10, 33, 100, 333 and 1000 µg/plate.
Second experiment:
TA1535, TA1537, TA98, TA100: 10, 33, 100, 333 and 1000 µg/plate.
WP2uvrA: 33, 100, 333, 1000 and 3330 µg/plate.
The highest concentration used was the level at which the test substance inhibited bacterial growth or the dose level at which the test substance exhibited limited solubility. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation; all strains
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation; WP2uvrA strain
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation; TA100 strain
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation; TA98
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation; TA1537 strain
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation; TA1535 strain
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate in each strain
- Number of independent experiments: two, both in absence and presence of S9-metabolic activation in each strain.
METHOD OF TREATMENT/ EXPOSURE:
- Direct plate assay: 0.1 ml of a fresh bacterial culture (10^9 cells/ml) of one of the tester strains, 0.1 ml of a dilution of the test substance in DMSO and either 0.5 ml S9-mix or 0.5 ml 0.1 M phosphate buffer were added to 3 ml molten top agar and poured onto a selective agar plate.
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: after solidification of the top agar, the plates were inverted and incubated in the dark at 37.0°C for 48 h.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined in the dose range finding test. - Rationale for test conditions:
- Selection of an adequate range of doses was based on a dose range finding test with the strains TA100 and WP2uvrA, both with and without S9-mix. Eight concentrations, 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate were tested in triplicate. This dose range finding test was part of the first experiment of the mutation assay.
At least five different doses (increasing with approximately half-log steps) of the test substance were tested in triplicate in each strain.
The test substance was tested both in the absence and presence of S9-mix in each strain, in two independent experiments. - Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if the total number of revertants in tester strain TA100 is not greater than two times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three times the concurrent control. The negative response should also be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if the total number of revertants in tester strain TA100 is greater than two times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three times the concurrent control.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A moderate reduction of the bacterial background lawn was observed at resp. 333 and 1000 μg/plate both in the presence and absence of S9-mix.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight reduction of the bacterial background lawn was observed at 333 and 1000 μg/plate both in the presence and absence of S9-mix.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight or moderate reduction of the bacterial background lawn was observed at resp. 333 and 1000 μg/plate both in the presence and absence of S9-mix.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight or moderate reduction of the bacterial background lawn was observed at resp. 333 and 1000 μg/plate both in the presence and absence of S9-mix.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Concentration of the test substance resulting in precipitation:
S. typhimurium TA1535, TA1537, TA98, TA100 and E. coli WP2uvrA: 3330 μg/plate.
STUDY RESULTS
- Concurrent vehicle negative and positive control data:
The negative and strain-specific positive control values were within historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
- Concentration of the test substance observed to be toxic to bacteria:
S. typhimurium TA1535, TA1537, TA98, TA100: 333 μg/plate.
E. coli WP2uvrA: no toxicity observed.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that butoxystyrene is not mutagenic in the S. typhimurium reverse mutation assay and in the E. coli reverse mutation assay.
- Executive summary:
Mutagenic activity of butoxystyrene was evaluated in the S. typhimurium reverse mutation assay with four histidine-requiring strains (TA1535, TA1537, TA98 and TA100) and the E. coli reverse mutation assay with a tryptophan-requiring strain (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix.
In the dose range finding test, butoxystyrene was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. In tester strain TA100, toxicity was observed at dose levels of 333 μg/plate and above in the absence and presence of S9-mix. In tester strain WP2uvrA, no toxicitiy was observed at any of the dose levels. Results of the dose range finding test were reported as part of the first experiment. Butoxystyrene precipitated on the plates at dose levels of 3330 and 5000 μg/plate.
Based on results of the dose range finding test, butoxystyrene was tested in the first mutation assay at a concentration range of 10 to 1000 μg/plate in the absence and presence of 5% (v/v) S9-mix in tester strains TA1535, TA1537 and TA98. Toxicity was observed in all tester strains.
In an independent repeat of the assay with additional parameters, butoxystyrene was tested at a concentration range of 10 to 1000 μg/plate in the tester strains TA1535, TA1537, TA98 and TA100 and at a concentration range of 33 to 3330 μg/plate in tester strain WP2uvrA in the absence and presence of 10% (v/v) S9-mix. Toxicity was observed in all tester strains except in WP2uvrA.
Butoxystyrene did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation.
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