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EC number: 947-368-7 | 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 cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: Micronucleus induction
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 February 2018 to 19 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD Guideline 487, updated and adopted 26 September 2014
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- GLP compliance:
- yes
- Remarks:
- Refer to main study report
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- EC Number:
- 216-036-7
- EC Name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Cas Number:
- 1478-61-1
- Molecular formula:
- C15H10F6O2
- IUPAC Name:
- 4,4'-(1,1,1,3,3,3-hexafluoropropane-2,2-diyl)diphenol
- Reference substance name:
- Benzyltriphenylphosphonium, salt with 4,4'- [2,2,2- trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1)
- Cas Number:
- 75768-65-9
- IUPAC Name:
- Benzyltriphenylphosphonium, salt with 4,4'- [2,2,2- trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1)
- Details on test material:
- - Density: 1.38 g/cm3
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Purity: > 98 %
Method
- Target gene:
- micronuclei
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Details on mammalian cell type (if applicable):
- CELLS USED- Source of cells: Peripheral blood lymphocytes were obtained from a healthy non-smoking individual who had no recent history of radiotherapy, viral infection or the administration of drugs.- Suitability of cells: Use of HPBL has been demonstrated to be sensitive to the genotoxicity test for detection of micronuclei of a variety of chemicals- Sex, age and number of blood donors if applicable: Male/ 25 years old / One donor- Whether whole blood or separated lymphocytes were used if applicable: Whole blood- Methods for maintenance in cell culture if applicable: Peripheral blood lymphocytes were cultured in complete medium (RPMI 1640 containing 15% heat inactivated fetal bovine serum, 2mM L glutamine, 100 units penicillin and 100 µg/mL streptomycin) by adding 0.5 mL heparinized blood to a centrifuge tube containing 5 mL of complete medium with 2% phytohemagglutinin. The cultures were incubated under standard conditions (37 ± 1C in a humidified atmosphere of 5 ± 1% CO2 in air) for 44-48 hours.MEDIA USED- Type and identity of media including CO2 concentration if applicable: Complete medium (RPMI 1640 containing 15% heat inactivated fetal bovine serum, 2mM L glutamine, 100 units penicillin and 100 µg/mL streptomycin) and RPMI 1640 Serum-free medium supplemented with 2 mM L glutamine, 100 units/mL penicillin, 100 µg/mL streptomycin- Properly maintained: [yes/no]: Yes
- Cytokinesis block (if used):
- Cytochalasin B (cytoB) was dissolved in DMSO to a stock concentration of 2 mg/mL. It was used at 6 µg/mL concentration to block cytokinesis.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 was used as the metabolic activation system
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO - Justification for choice of solvent/vehicle: DMSO was the vehicle of choice based on the solubility of the test substance and compatibility with the target cells. In a solubility test conducted at BioReliance, upon sonication for five minutes at 36.8 ºC, the test substance formed a clear and soluble solution in DMSO at a concentration of approximately 500 mg/mL, the maximum concentration tested for solubility.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Vinblastine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION- Exposure duration: HPBL were treated for 4 hours in the absence and presence of S9, and for 24 hours in the absence of S9, by incorporation of the test substance vehicle mixture into the treatment medium.
STAIN (for cytogenetic assays): acridine orange
NUMBER OF REPLICATIONS: Two
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: Cells were collected by centrifugation, swollen with 0.075M KCl, washed with fixative (methanol: glacial acetic acid, 25:1 v/v), capped and the slides were prepared immediately after harvest. To prepare slides, the cells were collected by centrifugation and the suspension of fixed cells was applied to glass microscope slides and air-dried.
NUMBER OF CELLS EVALUATED: A minimum of 2000 binucleated cells from each concentration (if possible, 1000 binucleated cells from each culture) were examined and scored for the presence of micronuclei.
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: Micronuclei in a binucleated cell (MN-BN) were recorded if they met the following criteria:• the micronucleus should have the same staining characteristics as the main nucleus• the micronuclei should be separate from the main nuclei or just touching (no cytoplasmic bridges)• the micronuclei should be of regular shape and approximately 1/3 or less than the diameter of the main nucleus
DETERMINATION OF CYTOTOXICITY- Method: Cytokinesis-blocked proliferation index (CBPI) relative to the vehicle control - Evaluation criteria:
- The test substance was considered to have induced a positive response if • at least one of the test concentrations exhibited a statistically significant increase when compared with the concurrent negative control (p ≤ 0.05), and• the increase was concentration-related (p ≤ 0.05), and• results were outside the 95% control limit of the historical negative control data.The test substance was considered to have induced a clear negative response if none of the criteria for a positive response were met.
- Statistics:
- Statistical analysis was performed using the Fisher's exact test (p = 0.05) for a pairwise comparison of the percentage of micronucleated cells in each treatment group with that of the vehicle control. The Cochran-Armitage trend test was used to assess dose-responsiveness.
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Negative
- Remarks:
- Bisphenol AF salt was negative for the induction of micronuclei in the presence and absence of the exogenous metabolic activation system.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the assay described in this report, Bisphenol AF Salt was concluded to be negative for the induction of micronuclei in the non-activated and S9-activated test systems in the in vitro mammalian micronucleus test using human peripheral blood lymphocytes.
- Executive summary:
The test substance, Bisphenol AF Salt,was tested to evaluate the potential to induce micronuclei in human peripheral blood lymphocytes (HPBL) in both the absence and presence of an exogenous metabolic activation system. Dimethyl sulfoxide (DMSO)was used as the vehicle.
In the preliminary toxicity assay, the doses tested ranged from 0.2 to 2000 µg/mL, which was the limit dose for this assay. Cytotoxicity [ ≥50%cytokinesis-blocked proliferation index(CBPI) relative to the vehicle control] was observed at doses ≥ 60 µg/mL in the non‑activated and S9‑activated 4-hour exposure groups and at doses ≥ 20 µg/mL in the non‑activated 24‑hour exposure group. At the conclusion of the treatment period, visible precipitate was observed at doses ≥ 200 µg/mL in all three exposure groups. Based upon these results, the doses chosen for the micronucleus assay ranged from 10 to 60 µg/mL for the non‑activated 4‑hour exposure group, from 20 to 50 µg/mL for the S9-activated 4-hour exposure group, and from 2.5 to 15 µg/mL for the non-activated 24-hour exposure group.
In the initial micronucleus assay, cytotoxicity ( ≥ 50% CBPI relative to the vehicle control) was observed at doses ≥ 50 µg/mL in the non‑activated 4-hour exposure group; at doses ≥ 35 µg/mL in the S9‑activated 4-hour exposure group; and at doses ≥ 8 µg/mL in the non‑activated 24-hour exposure group. The doses selected for evaluation of micronuclei were 20, 40, and 55 µg/mL for the non-activated 4-hour exposure group and 2.5, 6, and 9 µg/mL for the non‑activated 24-hour exposure group.
In the non-activated 4-hour exposure group, no significant or dose‑dependent increases in micronuclei induction were observed at any dose (p > 0.05; Fisher’s Exact and Cochran-Armitage tests).
In the S9-activated 4-hour exposure group, due to lack of requisite cytotoxicity, the micronucleus assay was repeated at doses ranging from 10 to 37 µg/mL. In the non-activated 24-hour exposure group, due to lack of statistically significant induction of micronuclei in the positive control, the micronucleus assay was also repeated at doses ranging from 2.5 to 15 µg/mL.
In the repeat assay, cytotoxicity ( ≥ 50% CBPI relative to the vehicle control) was observed at doses ≥ 30 µg/mL in the S9‑activated 4-hour exposure group and at doses ≥ 8 µg/mL in the non‑activated 24-hour exposure group. The doses selected for evaluation of micronuclei were 10, 20, and 30 µg/mL for the S9-activated 4-hour exposure group; and 2.5, 5, and 8 µg/mL for the non‑activated 24-hour exposure group.
No significant or dose‑dependent increases in micronuclei induction were observed in treatment groups with or without S9 (p > 0.05; Fisher’s Exact and Cochran-Armitage tests).
These results indicate Bisphenol AF salt was negative for the induction of micronuclei in the presence and absence of the exogenous metabolic activation system.
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