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EC number: 611-390-2 | CAS number: 56467-43-7
- 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:
- 22.10.2009 to 15.12.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester
- EC Number:
- 611-390-2
- Cas Number:
- 56467-43-7
- Molecular formula:
- C17H14O3
- IUPAC Name:
- 2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester
- Reference substance name:
- (4-benzoylphenyl) acetate
- Cas Number:
- 13031-44-2
- Molecular formula:
- C15H12O3
- IUPAC Name:
- (4-benzoylphenyl) acetate
- Test material form:
- solid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- 4-(Methacryloyloxy) bezophenone 97.26 %
Benzophenone acetate: 1.95 %
Method
- Target gene:
- his-locus
TA98: his D 3052; rfa"; uvrB·; R-factor: frame shift mutations
TA 100: his G 46; rfa·; uvrB"; R-factor: base-pair substitutions
TA 1535: his G 46; rfa·; uvrB": base-pair substitutions
TA 1537: his C 3076; rfa"; uvrB·: frame shift mutations
TA 102: his G 428 (pAQI ); rfa"; R-factor: base-pair substitutions
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment I:
10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
3.16, 10.0, 31.6, 100, 316, 1000 and 2500 μg/plate (only TA I 02 without metabolic activation)
Experiment II:
3.16, 10.0,31.6, 100,316, 1000 and 2500 μg/plate (TA 98 and TA 1535 with and without metabolic activation)
1.00, 3.16, 10.0, 31.6, 100, 316 and 1000 μg/plate (TA 100 and TA 1537 with and without metabolic activation, TA 102 with metabolic activation)
0.316, 1.00, 3 .16, 10.0, 31.6, 100 and 316 μg/plate (TA 102 without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility properties + relative nontoxicity to the bacteria
Controlsopen allclose all
- Positive controls:
- yes
- Remarks:
- without metablic activation
- Positive control substance:
- sodium azide
- Remarks:
- Tester Strains: S. typhimurium: TA 100, TA 1535 Name: Sodium azide, NaN3 Purity: at least 99% Dissolved in: Aqua dest. Concentration: 10 µg/plate
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine, 4-NOPD
- Remarks:
- Tester Strains: S. typhimurium: TA 98, TA 1537 Name: 4-nitro-o-phenylene-diamine, 4-NOPD Purity: >97% Dissolved in: DMSO Concentrations: 10 µg/plate forTA 98, 40 µ/plate for TA 1537
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Tester Strain: S. typhimurium: TA 102 Name: Methyl methane sulfonate, MMS Purity: 99.0% Dissolved in: Aqua dest. Concentration: 1 µg/plate
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene, 2-AA
- Remarks:
- Tester Strains: S. typhimurium: TA 98, TA 100, TA 1535, TA 1537 and TA 102 Purity: 96% Dissolved in: DMSO Concentrations: 2.5 µg/plate; 10 µg/plate for TA 102
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Aqua dest.
- Remarks:
- Solvent controls, consisting of solvent or vehicle alone as well as untreated controls were treated in the same way as the treatment groups.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Remarks:
- Solvent controls, consisting of solvent or vehicle alone as well as untreated controls were treated in the same way as the treatment groups.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: at least 48 h
NUMBER OF EXPERIMENTS: 2 (one performed as pre-incubation assay, one as plate incorporation assay), 3 plates per concentration each
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity of the test article may be evidenced by a reduction in the number of spontaneous revertants, a clearing of the bacterial background lawn, or by degree of survival of treated cultures.
OTHER:
automatic colony count with “AUTOCOUNT” (Artek systems, Biosys) - Evaluation criteria:
- - corresponding background growth on negative control and test plates
- normal range of spontaneous revertants: TA1535 (10-29), TA 1537 (5-28), TA 1538 (12-37), TA 98 (15-57), TA 100 (77-189)
- test material is considered mutagenic if either a dose related and reproducible increase in revertant numbers or a significant and reproducible increase in revertant numbers for at least one test concentration in induced
- a significant increase in revertants means at least twice as high in TA 100 and a three times higher number in TA 1535, TA 1537, TA 1538, TA 89 compared to the negative control
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA 100, TA 1535, TA 1537, TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, 4-(Methacryloyloxy) benzophenone did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, 4-(Methacryloyloxy) benzophenone is considered to be non-mutagenic in this bacterial reverse mutation assay. - Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471, adopted 21 July 1997, strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 were exposed to 4 -(Methacryloyloxy) benzophenone in DMSO at concentrations of 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000.0 µg/plate in a plate incorporation assay in the presence and absence of mammalian metabolic activation (S9 mix).
4 -(Methacryloyloxy) benzophenone was tested up to cytotoxic concentrations. There was no evidence of induced mutant colonies over background.
The positive controls induced the appropriate responses in the corresponding strains.
This study is classified as acceptable and satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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