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EC number: 217-126-9 | CAS number: 1746-23-2
- 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:
- 31 January 2017 - 13 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ISO/IEC 17025:2005 (ISO/IEC, 2005)
- Version / remarks:
- 2005
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- p-tert-butylstyrene
- EC Number:
- 217-126-9
- EC Name:
- p-tert-butylstyrene
- Cas Number:
- 1746-23-2
- Molecular formula:
- C12H16
- IUPAC Name:
- p-tert-butylstyrene
- Test material form:
- liquid: volatile
1
- Specific details on test material used for the study:
- Synonyms: p-tert-butylstyrene
CAS No: 1746-23-2
Purity: 95.9%
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Remarks:
- reverted from histidine dependence (auxotrophy) to histidine independence (prototrophy) by frameshift mutagens.
- Species / strain / cell type:
- S. typhimurium TA 100
- Remarks:
- reverted by mutagens that cause both frameshift and basepair substitution mutations.
- Species / strain / cell type:
- S. typhimurium TA 1535
- Remarks:
- reverted by mutagens that cause basepair substitutions
- Species / strain / cell type:
- S. typhimurium TA 1537
- Remarks:
- reverted from histidine dependence (auxotrophy) to histidine independence (prototrophy) by frameshift mutagens.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Remarks:
- sensitive to basepair substitution mutations, rather than frameshift mutations
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9
- Test concentrations with justification for top dose:
- 10.0, 33.3, 100, 333, 1000, 3333 and 5000 μg per plate (for tester strains TA98, TA1537, WP2 uvrA in the presence and absence of S9 activation and TA100, TA1535 in the presence of S9 activation); and
1.00, 3.33, 10.0, 33.3, 100, 333 and 1000 μg per plate (for tester strains TA100, TA1535 in the absence of S9 activation) - Vehicle / solvent:
- DMSO (vehicle for Positive Controls: DMSO, except sterile water for sodium azide)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
- Initial cell density: 0.8 - 2 x 10(9) cells per mL
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY : The preliminary toxicity assay was used to establish the dose-range over which the test substance would be assayed. TA98, TA100, TA1535, TA1537 and WP2 uvrA were exposed to the vehicle alone and ten dose levels of the test substance, with a single plate/condition, on selective minimal agar in the presence and absence of Aroclor-induced rat liver S9. Dose levels for the mutagenicity assay were based upon post-treatment toxicity.
MUTAGENICITY ASSAY: One-half (0.5) milliliter of S9 or Sham mix (100 mM phosphate buffer at pH 7.4), 100 μL of tester strain (cells seeded) and 50.0 μL of vehicle or test substance dilution were added to 2.0 mL of molten selective top agar at 45±2°C. When plating the positive controls, the test substance aliquot was replaced by a 50.0 μL aliquot of appropriate positive control. After vortexing, the mixture was overlaid onto the surface of 25 mL of minimal bottom agar. After the overlay had solidified, the plates were inverted and incubated for 48 to 72 hours at 37±2°C. Plates that were not counted immediately following the incubation period were stored at 2-8°C until colony counting could be conducted.
- Evaluation criteria:
- - For the test substance to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test substance.
- Strains TA1535 and TA1537: Data sets were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 3.0 times the mean vehicle control value and above the corresponding acceptable vehicle control range.
- Strains TA98, TA100 and WP2 uvrA: Data sets were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2.0 times the mean vehicle control value and above the corresponding acceptable vehicle control range.
- An equivocal response is an increase in a revertant count that is greater than the acceptable vehicle control range but lacks a dose response or does not achieve the respective fold increase threshold cited.
- A response will be evaluated as negative, if it is neither positive nor equivocal. - Statistics:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 3333 μg per plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 3333 μg per plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 100 μg per plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 1000 μg per plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 100 μg per plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- In preliminary toxicity assay, toxicity was observed beginning at 100, 667 or 3333 μg per plate. Based upon these results, the maximum dose tested in the mutagenicity assay was 5000 μg per plate for tester strains TA98, TA1537, WP2 uvrA in the presence and absence of S9 activation and TA100, TA1535 in the presence of S9 activation and 1000 μg per plate for tester strains TA100, TA1535 in the absence of S9 activation.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was determined to be non-genotoxic with or without metabolic activation in the Ames test.
- Executive summary:
A study was conducted to determine the genotoxic potential of the test substanceaccording to OECD Guideline 471, in compliance with GLP.Salmonella typhimuriumstrains TA1535, TA1537, TA98 and TA100 andEscherichia colistrain WP2uvrA were treated with the test substance using both the Ames plate incorporation and preincubation methods, in triplicate both with and without the addition of a rat liver homogenate metabolizing system:Aroclor-induced rat liver (S9).In the preliminary toxicity assay, the dose levels tested were 6.67, 10.0, 33.3, 66.7, 100, 333, 667, 1000, 3333 and 5000 μg per plate. No precipitate was observed. Toxicity was observed beginning at 100, 667 or 3333 μg per plate. Based upon these results, in the mutagenicity assay, the dose levels tested were10.0, 33.3, 100, 333, 1000, 3333 and 5000 μg per plate for tester strains TA98, TA1537, WP2uvrA in the presence and absence of S9 activation and TA100, TA1535 in the presence of S9 activation and 1.00, 3.33, 10.0, 33.3, 100, 333 and 1000 μg per plate for tester strains TA100, TA1535 in the absence of S9 activation. No precipitate was observed. Toxicity was observed beginning at 100, 1000 or 3333 μg per plate with a few conditions. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. Under the study conditions, the test substance was considered to be non-mutagenic in the Ames test (Dakoulas, 2018).
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