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EC number: 943-359-7 | CAS number: 2149581-44-0
- 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:
- 30. Jun. 2015- 10. Jul. 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with detailed documentation, in accordance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- MAEEBP
- IUPAC Name:
- MAEEBP
- Details on test material:
- - Name of test material (as cited in study report): MAEEBP- Physical state: Colourless liquid- Composition of test material, percentage of components: 4-methacryloyl diethoxy benzophenone (purity 85 area %)- Impurities: 4-hydroxybenzophenone <5%, 4-methacryloyl benzophenone <5%, polymethacrylate <5%- Lot/batch No.: 150301- Expiration date of the lot/batch: 01.09.2015- Storage condition of test material: Fridge: 2-8° C, keep away from light and humidity
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium, other: TA 97 a
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- experiment 1: 50 µg/plate, 15 µg/plate, 5 µg/plate, 1.5 µg/plate and 0.5 µg/plate.experiment 2: 50 µg/plate, 25 µg/plate, 12.5 µg/plate, 6.3 µg/plate, 3.1 µg/plate and 1.6 µg/plate
- Vehicle / solvent:
- - vehicle for the test item: dimethyl sulfoxide (DMSO)- vehicle for the positive controls: DMSO (4-Nitro-1,2-phenylene Diamine, 2-Amino-anthracene, Benzo-a-pyrene) or demineralised water (Sodium azide)- vehicle for solvent controls: DMSO or demineralised water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- strains TA97a, TA98, TA100, TA102, TA1535 with and without S9
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine
- Remarks:
- strains TA97a, TA98 and TA102, no metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- strains TA97a, TA98, TA100, TA102, TA1535 with and without S9
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- strains TA100 and TA1535, no metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- strains TA97a, TA98, TA100, TA102, TA1535 with and without S9
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-anthracene
- Remarks:
- strains TA97a, TA100, TA102 and TA1535, with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- strains TA97a, TA98, TA100, TA102, TA1535 with and without S9
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- strain TA98, with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation in experiment 1, pre-incubation method in experiment 2- Experiment 1:Suspensions of bacterial cells are exposed to the test substance in the presence and in the absence of an exogenous metabolic activation system. In the plate incorporation method, these suspensions are mixed with an overlay agar and plated immediately onto minimal medium. In the pre-incubation method, the treatment mixture is incubated and then mixed with an overlay agar before plating onto minimal medium. After 2 or 3 days of incubation, revertant colonies are counted and compared to the number of spontaneous revertant colonies on solvent control plates.5 concentrations of the test item (0.5, 1.5, 5, 15, 50 µg/plate) dissolved in DMSO were used. 5 genetically changed strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 (genetically manipulated) and TA1535) were exposed to the test item both in the presence and in the absence of a metabolic activation system (S9-mix, rat liver S9-mix induced by Aroclor 1254) for 48 h, using the plate incorporation method.- Experiment 2: Suspensions of bacterial cells are exposed to the test substance in the presence and in the absence of an exogenous metabolic activation system. In the pre-incubation method, the treatment mixture is incubated and then mixed with an overlay agar before plating onto minimal medium. After 2 or 3 days of incubation, revertant colonies are counted and compared to the number of spontaneous revertant colonies on solvent control plates.6 concentrations of the test item (1.6, 3.1, 6.3, 12.5, 25, 50 µg/plate) dissolved in DMSO were used. 5 genetically changed strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 (genetically manipulated) and TA1535) were exposed to the test item both in the presence and in the absence of a metabolic activation system (S9-mix, rat liver S9-mix induced by Aroclor 1254) for 48 h, using the pre-incubation method.
- Evaluation criteria:
- The mean values and standard deviations of each threefold determination of revertant colonies are calculated as well as the increase factor of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls. A substance is considered to have mutagenic potential, if a reproducible increase of re-vertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
- Statistics:
- The mean values and standard deviations of each threefold determination of revertant colonies are calculated as well as the increase factor of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls.
Results and discussion
Test results
- Species / strain:
- other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
- Experiment 1:
None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. The test item did not show any mutagenic effects in the first experiment.
The test item showed no precipitates on the plates in all tested concentrations
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range, with exception of strain TA97a with and without S9. Both values lay outside the range of historical laboratory control data. The deviations of negative controls were not confirmed in the respective independent second experiment. All positive controls showed mutagenic effects with and without metabolic activation. - Experiment 2: The test item did not show mutagenic effects in the second experiment, either.The test item showed no precipitates on the plates in all tested concentrations.
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation. However, the experimental value of the positive control using strain TA1535 without S9 deviated from historical data of the laboratory. This deviation was not confirmed in the results of the first experiment.
Under the conditions of experiment 1 and experiment 2, the test item did not show mutagenic effects towardsSalmonella typhimurium,strainsTA97a, TA98, TA100, TA102 and TA1535.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negativeUnder the conditions of the test, the test item did not show mutagenic effects towards Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535. Therefore, no concentration-effect relationship could be determined.The test item MAEEBP is considered as “not mutagenic under the conditions of the test”.
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