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EC number: 680-046-1 | CAS number: 74462-02-5
- 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:
- March to April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD method without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4'-(2-ethylhexane-1,1-diyl)diphenol
- EC Number:
- 680-046-1
- Cas Number:
- 74462-02-5
- Molecular formula:
- C20H26O2
- IUPAC Name:
- 4,4'-(2-ethylhexane-1,1-diyl)diphenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: 4,4’-(2-Ethylhexylidene)bisphenol
Other name: BisP-IOTD
CAS nunber: 74462-02-5
Lot number: 120601
Supplier and date of receipt: Honshu Chemical Industry Co., Ltd., February 25, 2013
Amount of supplied, used: 10 g, approximately 0.44 g
Purity: 99.6%
Molecular weight: 298.4
Melting point: 88.9°C
Description at ordinary temperature: white powder
Stability: stable at room temperature
Solubility: slightly soluble in water, dissolves in acetone at 100 w/v% , insoluble in water, dissolves in dimethylsulfoxide at 5 wt% or more and at 10 wt% or more in acetone
Stability in solvent: stable in water, dimethylsulfoxide and acetone
Storage conditions: sealed, room temperature (1 to 30 °C)
Place of storage: room temperature cabinet in the dispensary of the main research building (allowable range of temperature, 1 to 30 °C)
Actual storage temperature: 18 to 21 °C
Storage period: February 25, 2013 to March 25, 2013
Constituent 1
Method
- Target gene:
- The Salmonella typhimurium histidine (his) and the E. coli tryptophan (trp) reversion system
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:
- S9-mix
- Test concentrations with justification for top dose:
- dose finding study: 15.8, 50.0, 158, 500, 1580, 5000 µg/plate (with and without S9)
main study: 5.0, 10.0, 20.0, 40.0, 80.0 and 160 µg/plate (without S9) and 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate (with S9)
confirmatory study: 3.75, 7.50, 15.0, 30.0, 60.0, 120 µg/plate (without S9) and 11.3, 22.5, 45.0, 90.0, 180 and 360 µg/plate (with S9) - Vehicle / solvent:
- dimethylsulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with and without metabolic activation
- Positive control substance:
- 9-aminoacridine
- sodium azide
- furylfuramide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- The studies were performed in the presence and absence of metabolic activation in each strain. The negative and positive controls were also included. Minimum glucose agar plates were prepared in duplicate per dose for the test substance, negative and positive control groups in the dose-nding study and in triplicate in the main and conrmatory studies. The doses of positive control substances, which have been generally used in
bacterial reverse mutation tests, are shown below.
TA100 without metabolic activation: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide 0.01 µg/plate
TA100 with metabolic activation: 2-aminoanthracene 1.0 µg/plate
TA1535 without metabolic activation: Sodium azide 0.5 µg/plate
TA1535 with metabolic activation 2-aminoanthracene: 2.0 µg/plate
WP2 uvrA without metabolic activation 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide: 0.01 µg/plate
WP2 uvrA with metabolic activation 2-aminoanthracene: 10.0 µg/plate
TA98 without metabolic activation 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide: 0.1 µg/plate
TA98 with metabolic activation 2-aminoanthracene: 0.5 µg/plate
TA1537 without metabolic activation 9-aminoacridine: 80.0 µg/plate
TA1537 with metabolic activation 2-aminoanthracene: 2.0 µg/plate
Preparation of S9 mix
The frozen S9 at -80 °C was thawed and was mixed with Co-factor solution prior to use in the ratio of 1:9. The composition in 1 mL of S9 mix is shown below. The prepared S9 mix was refrigerated in an ice bath.
S9 0.1 mL
MgCl2 8 µmol/mL
KCl 33 µmol/mL
Glucose-6-phosphate 5 µmol/mL
NADPH 4 µmol/mL
NADH 4 µmol/mL
Sodium phosphate buffer, pH 7.4 100 µmol/mL - Evaluation criteria:
- The test results were judged positive when biologically meaningful increase in the number of revertant colonies, such as dose-related increase with reproducibility were observed.
- Statistics:
- The number of revertant colonies per plate, the mean values and standard deviation per dose of the test substance, and the negative control were tabulated for each strain. The number of revertant colonies per plate and the mean values were tabulated for each strain as for the positive control. Dose-response curves of each strain were drawn for the test substance group.
Two statistical analyses of Dunnett’s multiple comparison method (one-side test) and linear regression method were used in this test. The number of revertant colonies of each bacterial strain at each dose in the main study and confirmatory study was compared with that of the negative control in both the presence and absence of metabolic activation, and statistically significant difference in the number of revertant colonies between those two groups was analyzed first by the multiple comparison method (p<0.05). The dose-reactivity was analyzed by linear regression method (p<0.05) when the statistically significant difference was detected by the multiple comparison method.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 158 µg/ml (without S9) and 500 µg/ml (with S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 158 µg/ml (without S9) and 500 µg/ml (with S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Dose-finding Study
The test substance showed growth-inhibition at the dose of 158 µg/plate or more in the absence of metabolic activation and at the dose of 500 µg/plate or more in the presence of metabolic activation. On the other hand, increase in the number of revertant colonies compared with the negative control was not observed in any bacterial strains at any dose levels regardless of the presence or absence of metabolic activation. Precipitation of the test substance was observed at the dose of 5000 µg/plate in the absence of metabolic activation and at the dose of 1580 1.1g/plate or more in the presence of metabolic activation.
Main Study
The test substance showed growth-inhibition at the dose of 80.0 µg/plate or more in the absence of metabolic activation and at the dose of250 µg/plate or more in the presence of metabolic activation. On the other hand, increase in the number of revertant colonies compared with the negative control was not observed in any bacterial strains at any dose levels regardless of the presence or absence of metabolic activation. Precipitation of the test substance was not observed at any dose levels regardless of the presence or absence of metabolic activation.
Confirmatory Study
The test substance showed growth-inhibition at the dose of 60.0 µg/plate or more in the absence of metabolic activation and at the dose of 360 µg/plate in the presence of metabolic activation. On the other hand, increase in the number of revertant colonies compared with the negative control was not observed in any bacterial strains at any dose levels regardless of the presence or absence of metabolic activation. Precipitation of the test substance was not observed at any dose levels regardless of the presence or absence of metabolic activation.
Any other information on results incl. tables
Reverse mutation test of 4,4’-(2-Ethylhexylidene)bisphenol was performed using five bacterial strains, Salmonella typhimurium TA98, TA100, TA1535, TA1537, and Escherichia coli WP2 uvrA, in the presence and absence of metabolic activation with a pre-incubation method at 37 °C for 20 minutes.
Statistically significant difference in the number of revertant colonies between the test substance group and the negative control was not observed at any dose levels in any bacterial strains regardless of the presence or absence of metabolic activation. Reproducibility was observed between the results from the main study and confirmatory study. These results revealed that no biologically meaningful increase in the number of revertant colonies due to mutagenicity of the test substance was observed. The number of revertant colonies in the positive control was twice or more than that of the negative control in all bacterial strains in both the presence and absence of metabolic activation. The mean values of colony counts in the negative and positive controls were within the range of background data both in the main study and confirmatory study. No contaminants were found in the sterility test. These results demonstrated that the test was properly performed. No suspected factor that affected the reliability of the studies was confirmed.
Based on the above results, the test substance was considered to have no potency of mutagenicity under the conditions of this test.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The substance 4,4'-(2-Ethylhexylidene)bisphenol was found negative (with and without metabolic activation) in this Ames-bacterial reverse mutation assay using salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 as well as E. coli strain WP2 uvrA. - Executive summary:
The inducibility of gene mutation in 4,4'-(2-Ethylhexylidene)bisphenol was evaluated by the reverse mutation test with a pre-incubation method at 37 °C for 20 minutes using five bacterial strains, Salmonella typhimurium TA98, TA100, TA1535, TA1537, and Escherichia coli WP2 uvrA. The test was composed of the dose-finding, main and confirmatory studies, and the reproducibility between the results from the main and confirmatory studies was confirmed. All studies were performed in the presence and absence of metabolic activation. As a result, biologically meaningful increase in the number of revertant colonies due to mutagenicity of the test substance was not observed in any bacterial strains at any dose levels regardless of the presence or absence of metabolic activation. The number of revertant colonies in the positive control was twice or more than that of the negative control in all bacterial strains regardless of the presence or absence of metabolic activation. The mean values of revertant colonies in the negative and positive controls were within the range of calculated reference value from background data in the main and confirmatory studies. No contaminants were found in the sterility test. These results demonstrated that the test was properly performed. No suspected factor that affected the reliability of the studies was confirmed.
Based on the above results, the inducibility of gene mutation in the test substance was determined as negative under the test conditions employed.
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