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EC number: 244-096-4 | CAS number: 20882-04-6
- 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:
- June - July 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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
- 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-[(2-methyl-1-oxoallyl)oxy]ethyl] hydrogen succinate
- EC Number:
- 244-096-4
- EC Name:
- [2-[(2-methyl-1-oxoallyl)oxy]ethyl] hydrogen succinate
- Cas Number:
- 20882-04-6
- Molecular formula:
- C10H14O6
- IUPAC Name:
- 4-{2-[(2-methylprop-2-enoyl)oxy]ethoxy}-4-oxobutanoic acid
- Reference substance name:
- 2-hydroxyethyl methacrylate
- EC Number:
- 212-782-2
- EC Name:
- 2-hydroxyethyl methacrylate
- Cas Number:
- 868-77-9
- Molecular formula:
- C6H10O3
- IUPAC Name:
- 2-hydroxyethyl methacrylate
- Reference substance name:
- Succinic acid
- EC Number:
- 203-740-4
- EC Name:
- Succinic acid
- Cas Number:
- 110-15-6
- Molecular formula:
- C4H6O4
- IUPAC Name:
- succinic acid
- Test material form:
- liquid
- Details on test material:
- - Name as cited in the report: Methacryloyloxyethyl succinate
- EC-name: [2-[(2-methyl-1-oxoallyl)oxy]ethyl] hydrogen succinate
- CAS: 20882-04-6
- EC-No.: 244-096-4
- Batch No.: 3903/64
- Storage: 4-8°C, protected from heat and sunlight
- Description: yellowish liquid
- Density: 1.1884 g/kg
- Molecular weight: approx. 230 g/mol
- Formula: C10H14O6
- Purity: 84% (NMR)
Constituent 1
impurity 1
impurity 2
Method
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:
- - Pre-experiment: 0.00316, 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 µL/plate
- Main experiment: 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 µL/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine TA98, TA1537
- Remarks:
- Without S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (all strains)
- Remarks:
- With S9-mix
- Details on test system and experimental conditions:
- Samples of each tester strain were grown by culturing for 12 h at 37°C in Nutrient Broth to the late exponential or early stationary phase of growth (approx. 10E9 cells/mL). The nutrient medium consists per litre:
- 8 g Nutrient Broth
- 5 g NaCI
A solution of 125 µL ampicillin (10 mg/mL) (TA 98, TA 100, TA 102) was added in order to retain the phenotypic characteristics of the strain.
The Vogel-Bonner Medium E agar plates with 2 % glucose used in the Ames Test were prepared by Eurofins Munich or provided by an appropriate supplier. Quality controls were performed. Sterilisation was performed for 20 min at 121°C in an autoclave.
The overlay agar contains per litre:
- 7.0 g Agar Agar
- 6.0 g NaCI
- 10.5 mg L-histidine x HCI x H2O
- 12.2 mg biotin
Sterilisation was performed for 20 min at 121°C in an autoclave. - Evaluation criteria:
- CYTOTOXICITY:
Cytotoxicity can be detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately <= 0.5 in relation to the solvent control.
VALIDITY:
A test is considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to ampicillin (TA 98, TA 100, TA 102)
- the mean values of the spontaneous reversion frequency of the control plates with and without S9 mix are within the historical control data range
- corresponding background growth on negative control, solvent control and test plates is observed
- the positive controls show a distinct enhancement of revertant rates over the control plate
- at least five different concentrations of each tester strain are analysable.
MUTAGENICITY
The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (exact values).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as folIows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control.
According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary. A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and 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
Any other information on results incl. tables
No precipitation of the test item was observed in any tester strain used in experiment l and II (with and without metabolic activation).
In experiment I (Plate-incorporation Test) toxic effects of the test item were observed only in tester strain TA 1535 at a concentration of 5.0 µL/plate (with metabolic activation). In tester strain TA 1535 (without metabolic activation) the mutation factor of the negative control was reduced to 0.5. Due to the fact that the mean value as well as all single values of the negative control were within the historical data range and no concomitant reducing of the background lawn was observed this finding was regarded as not biologically relevant and did not influence the results of the experiment.
In experiment II (Pre-incubation Test) toxic effects of the test item were noted only in tester strain TA 98 at a concentration of 5.0µL/plate (with metabolic activation) and in tester strain TA 1537 at concentrations of 2.5 µL/plate and higher (without metabolic activation). The reduction in the number of revertants down to a mutation factor of 0.4 found in tester strain TA 1535 at a concentration of 0.316 µL/plate and down to a mutation factor of 0.5 at a concentration of 0.100 µL/plate in tester strain TA 1537 (both without metabolic activation) was regarded as not biologically relevant due to lack of a dose-response relationship.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Methacryloyloxyethyl succinate at any concentration level, neither in the presence nor absence of metabolic activation in experiment l and II.
The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments. The negative control plates with and without S9 mix were within the historical control data range. The slightly higher spontaneous reversion frequency in tester strain TA 1537 in experiment I (35 revertants instead of 27 revertants) was regarded as not biologically relevant and did not influence the validity of the results.
EXPERIMENT I (Plate-incorporation Test)
Mean revertant colonies per plate
TA 98 | TA98 | TA 100 | TA 100 | TA 1535 | TA 1535 | TA 1537 | TA 1537 | TA 102 | TA 102 | |
-S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
neg. control | 48 | 40 | 105 | 112 | 9 | 11 | 35 | 24 | 159 | 261 |
solvent control | 49 | 42 | 90 | 111 | 20 | 9 | 27 | 21 | 179 | 223 |
test item 0.0316 µL | 48 | 29 | 87 | 121 | 17 | 9 | 22 | 18 | 214 | 266 |
test item 0.100 µL | 40 | 42 | 94 | 112 | 17 | 10 | 27 | 20 | 249 | 270 |
test item 0.316 µL | 37 | 38 | 89 | 112 | 22 | 9 | 26 | 18 | 220 | 251 |
test item 1.0 µL | 28 | 40 | 101 | 101 | 21 | 6 | 37 | 16 | 209 | 219 |
test item 2.5 µL | 33 | 33 | 98 | 112 | 17 | 10 | 32 | 18 | 213 | 248 |
test item 5.0 µL | 37 | 40 | 93 | 103 | 14 | 5 | 27 | 18 | 230 | 304 |
pos. control | 299 | 2758 | 844 | 2045 | 1143 | 128 | 111 | 258 | 442 | 679 |
EXPERIMENT II (Pre-incubation Test)
Mean revertant colonies per plate
TA 98 | TA98 | TA 100 | TA 100 | TA 1535 | TA 1535 | TA 1537 | TA 1537 | TA 102 | TA 102 | |
-S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
neg. control | 23 | 34 | 88 | 106 | 14 | 9 | 5 | 10 | 177 | 203 |
solvent control | 19 | 41 | 66 | 78 | 13 | 9 | 10 | 7 | 201 | 161 |
test item 0.0316 µL | 28 | 35 | 66 | 82 | 12 | 8 | 7 | 8 | 193 | 199 |
test item 0.100 µL | 19 | 31 | 58 | 72 | 8 | 10 | 5 | 6 | 198 | 166 |
test item 0.316 µL | 16 | 36 | 50 | 67 | 5 | 6 | 6 | 10 | 184 | 140 |
test item 1.0 µL | 18 | 30 | 55 | 77 | 8 | 12 | 7 | 7 | 228 | 163 |
test item 2.5 µL | 20 | 26 | 50 | 79 | 7 | 7 | 5 | 8 | 203 | 173 |
test item 5.0 µL | 23 | 23 | 55 | 72 | 8 | 8 | 5 | 6 | 169 | 181 |
pos. control | 321 | 1164 | 327 | 835 | 548 | 55 | 110 | 218 | 663 | 504 |
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Methacryloyloxyethyl succinate did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Methacryloyloxyethyl succinate is considered to be non-mutagenic in this bacteriaI reverse mutation assay.
- Executive summary:
In order to investigate the potential of Methacryloyloxyethyl succinate for its ability to induce gene mutations the plate incorporation test (experiment I) and the pre-incubation test (experiment II) were performed with the Salmonella typhimuriumstrains TA 98, TA 100, TA 1535, TA 1537 and TA 102.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments:
0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 µL/plate
No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).
No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaIuated (with and without metabolic activation) in experiment I. In experiment II toxic effects of the test item were noted in tester strain TA 98 at a concentration of 5.0 µL/plate and in tester strain TA 1537 at concentrations of 2.5 µL/plate and higher (both without metabolic activation).
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Methacryloyloxyethyl succinate at any concentration level, neither in the presence nor absence of metabolic activation in experiment l and II.
The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Methacryloyloxyethyl succinate did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, Methacryloyloxyethyl succinate is considered to be non-mutagenic in this bacteriaI reverse mutation assay.
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