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EC number: 884-585-5 | CAS number: 270586-78-2
- 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 cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2023
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 023
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EU) 2017/735 amending Regulation (EC) No. 440/2008, EU Method B.49: “In Vitro Mammalian Cell Micronucleus Test”, adopted 14. Feb. 2017
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- [bis(4-methylphenyl)phosphoroso](2,4,6-trimethylphenyl)methanone
- EC Number:
- 884-585-5
- Cas Number:
- 270586-78-2
- Molecular formula:
- C24H25O2P
- IUPAC Name:
- [bis(4-methylphenyl)phosphoroso](2,4,6-trimethylphenyl)methanone
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
Results and discussion
Test results
- Species / strain:
- lymphocytes: cultivated human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, under the experimental conditions reported, (di-p-tolylphosphoryl)(mesityl)methanone is able to induce the formation of micronuclei in hu-man lymphocytes in vitro.
The result of the micronucleus test with the test item (di-p-tolylphosphoryl)(mesityl)methanone is considered as “positive” under the conditions of the test. - Executive summary:
This study was performed to assess the potential of (di-p-tolylphosphoryl)(mesityl)methanone to induce formation of micronuclei in human lym-phocytes cultured in vitro in absence and presence of an exogenous metabolic activation system (liver S9 mix from male rats, treated with Phenobarbital/5,6-Benzoflavone).
For the analysis of the genotoxic potential of the test item, 6 concentrations were tested in duplicate cultures of human lymphocytes in one valid experiment with metabolic activa-tion. Three concentrations were chosen for evaluation of genotoxicity each. A minimum of 1000 binucleated cells were evaluated per culture and were scored for the presence of micronuclei. The recorded values were compared with a negative control (solvent only, in this case ethanol 1% v/v).
Detailed data is presented in annex 4 (pre-experiment: page 37ff; pre-experiment II with-out metabolic activation: page 41ff, experiment I with metabolic activation: page 43ff).
The study is considered acceptable: micronucleus induction of the solvent controls was in the range of the historical control data/literature data. The positive control compounds Mitomycin C (0.3 µg/mL), CPA (15 µg/mL and 10 µg/mL) showed distinct increases in the number of binucleated cells with micronuclei.
In pre-experiment II without metabolic activation, turbidity of the test item was visible at the two highest test item concentrations (0.25 mg/mL and 0.13 mg/mL). At the two lower test item concentrations (0.06 mg/mL and 0.03 mg/mL) extreme cytotoxicity was observed. An evaluation of these concentrations was not possible. Since only two further test item con-centrations were available, an evaluation of micronuclei according to OECD 487 was not possible since < 3 test item concentrations were suitable. For that reason, only the con-trols were evaluated for micronuclei to show the validity of this approach.
In pre-experiment II with metabolic activation, turbidity of the test item was visible at the two highest test item concentrations (0.25 mg/mL and 0.13 mg/mL). At the next lower test item concentration (0.06 mg/mL) extreme cytotoxicity was observed. Only the three lowest test item concentrations (0.03 mg/mL, 0.02 mg/mL and 0.01 mg/mL) were suitable for scor-ing of micronuclei. At those three concentrations a moderate, very low and no cytotoxic effect was observed. For that reason, this pre-experiment II was evaluated as experiment I with metabolic activation.
In this approach the test item concentration 0.02 mg/mL induced a statistically significant increase in the number of binucleated cells containing micronuclei in comparison to the solvent control. In addition, all three values of the evaluated concentrations exceeded the control range of the solvent control. Only a clear dose-response was not detected since the micronucleus frequency at the highest analysable test item concentration (0.03 mg/mL) was lower than the one at the test item concentration 0.02 mg/mL. However, this effect could possibly be due to the relatively high cytotoxic effect at the concentration 0.03 mg/mL (cytostasis: 43.9 %) that may have led to an interference of cytotoxicity and genotoxicity .
Due to the obviously distinctly increased micronucleus frequencies at all three evaluated test item concentrations , the result of experiment I with metabolic activation is considered as “positive”.
In conclusion, under the experimental conditions reported, (di-p-tolylphosphoryl)(mesityl)methanone is able to induce the formation of micronuclei in hu-man lymphocytes in vitro.
The result of the micronucleus test with the test item (di-p-tolylphosphoryl)(mesityl)methanone is considered as “positive” under the conditions of the test.
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