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EC number: 811-451-5 | CAS number: 1802140-94-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From March 10, 2004 to March 26, 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted with read across substance according to OECD Guidelines 471 and EU Method B.13/14, in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide (P2O5)
- IUPAC Name:
- 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide (P2O5)
- Reference substance name:
- 1187441-10-6
- Cas Number:
- 1187441-10-6
- IUPAC Name:
- 1187441-10-6
- Test material form:
- other: Liquid
Constituent 1
Constituent 2
Method
- Target gene:
- TA1537: hisC3076
TA98: hisD3052
TA1535: hisG46
TA100: hisG46
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- The Salmonella typhimurium strains were regularly checked to confirm their histidine requirement, crystal violet sensitivity, ampicillin resistance (TA98 and TA100), UV-sensitivity and the number of spontaneous revertants.
The Escherichia coli WP2uvrA strain detects base-pair substitutions. The strain lacks an excision repair system and is sensitive to agents such as UV. The sensitivity of the strain to a wide variety of mutagens has been enhanced by permeabilization of the strain using Tris-EDTA treatment (ref.1). The strain was regularly checked to confirm the tryptophan-requirement, UV sensitivity and the number of spontaneous revertants. Stock cultures of the five strains were stored in liquid nitrogen (-196°C). - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver homogenate S9 fraction
- Test concentrations with justification for top dose:
- Dose range finding test: 3, 10, 33, 100, 333, 1,000, 3,330 and 5,000 μg/plate
Mutation test:
Experiment I: 3, 10, 33, 100, 333, 1,000, 3,330 and 5,000 μg/plate
Experiment II: 100, 333, 1,000, 3,330 and 5,000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide
- Stability in vehicle: Stable
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA98, TA100, TA1535, TA1537, WP2uvrA
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With metabolic activation (+S9 mix)
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA1535
- Positive control substance:
- sodium azide
- Remarks:
- Without metabolic activation (-S9 mix)
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without metabolic activation (-S9 mix)
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA98
- Positive control substance:
- other: daunomycin
- Remarks:
- Without metabolic activation (-S9 mix)
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA100
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without metabolic activation (-S9 mix)
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- WP2uvrA
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without metabolic activation (-S9 mix)
- Details on test system and experimental conditions:
- Cell culture:
Preparation of bacterial cultures:
Samples of frozen stock cultures of bacteria were transferred into enriched nutrient broth and incubated in a shaking incubator (37°C, 150 spm), until the cultures reached an optical density of 1.0±0.1 at 700 nm (10^9 cells/mL). Freshly grown cultures of each strain were used for a test.
Agar plates:
Agar plates (9 cm) contained 25 mL glucose agar medium. Glucose agar medium contained per liter: 18 g purified agar in Vogel-Bonner Medium E, 20 g glucose. The agar plates for the test with the Salmonella typhimurium strains also contained 12.5 μg/plate biotin and 15 μg/plate histidine and the agar plates for the test with the Escherichia coli strain contained 15 μg/plate tryptophan.
Top agar:
Milli-Q water containing 0.6% (w/v) bacteriological agar and 0.5% (w/v) sodium chloride was heated to dissolve the agar. Samples of 3 mL top agar were transferred into 10 mL glass tubes with metal caps. Top agar tubes were autoclaved for 20 min at 121±3°C.
Environmental conditions:
All incubations were carried out in the dark at 37±1°C. The temperature was monitored during the experiment.
Dose range finding test:
Selection of an adequate range of doses was based on a dose range finding test with strain TA100 and the WP2uvrA strain, both with and without S9-mix. Eight concentrations, 3, 10, 33, 100, 333, 1,000, 3,330 and 5,000 μg/plate were tested in triplicate. This dose range finding test was reported as a part of the first experiment of the mutation assay. The highest concentration of test substance used in the subsequent mutation assay was 5 mg/plate.
Mutation assay:
At least five different doses (increasing with approximately half-log steps) of the test substance were tested in triplicate in each strain. The test substance was tested both in the absence and presence of S9-mix in each strain, in two independent experiments. Top agar in top agar tubes was molten and heated to 45°C. The following solutions were successively added to 3 mL molten top agar: 0.1 mL of a fresh bacterial culture (10^9 cells/mL) of one of the tester strains, 0.1 mL of a dilution of the test substance in dimethyl sulfoxide and either 0.5 mL S9-mix (in case of activation assays) or 0.5 mL 0.1 M phosphate buffer (in case of non-activation assays). The ingredients were mixed on a Vortex and the content of the top agar tube was poured onto a selective agar plate. After solidification of the top agar, the plates were turned and incubated in the dark at 37±1°C for 48 h. After this period revertant colonies (histidine independent (His+) for Salmonella typhimurium bacteria and tryptophan independent (Trp+) for Escherichia coli) were counted.
Colony counting:
The revertant colonies (histidine independent c.q. tryptophan independent) were counted automatically with a Protos model 50,000 colony counter or manually, if less than 40 colonies per plate were present. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually. - Evaluation criteria:
- Acceptability of the assay:
A Salmonella typhimurium reverse mutation assay and/or Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
a) The negative control data (number of spontaneous revertants per plate) should be within the laboratory background historical range for each tester strain.
b) The positive control chemicals should produce responses in all tester strains, which are within the laboratory historical range documented for each positive control substance. Furthermore, the mean plate count should be at least three times the concurrent vehicle control group mean.
c) The selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.
Data evaluation:
No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces at least a 2-fold, dose related increase in the number of revertants with respect to the number induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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
- Additional information on results:
- Dose range finding test:
Precipitate:
The test substance did not precipitate in the top agar. Precipitation of test substance on the plates was not observed at the start or at the end of the incubation period in both tester strains.
Toxicity:
To determine the toxicity of test substance, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined. A reduction in the number of revertants equal to the minimal value of the historical control data range is not considered biologically relevant and, therefore, will not be considered cytotoxic. No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
Mutation assay:
Based on the results of the dose range finding test, test substance was tested up to concentrations of 5,000 μg/plate in the absence and presence of S9-mix in two mutation assays. The first mutation experiment was performed with the strains TA1535, TA1537 and TA98 and the second mutation experiment was performed with the strains TA1535, TA1537, TA98, TA100 and WP2uvrA. Test substance did not precipitate in the top agar. Precipitation of test substance on the plates was not observed at the start or at the end of the incubation period.
Toxicity:
In both mutation assays, there was no reduction in the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in all tester strains in the absence and presence of S9-mix.
Number of revertants:
All bacterial strains showed negative responses over the entire dose range, i.e. no dose-related, two-fold, increase in the number of revertants in two independently repeated experiments. The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The negative and strain-specific control values were within laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance was not mutagenic either in the presence or absence of metabolic activation under the conditions of this bacterial reverse mutation assay. - Executive summary:
A study was conducted to test the mutagenic potential of the read across substance (2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide (P2O5)) in a bacterial reverse mutation assay performed according to OECD Guideline 471 and EU Method B.13/14, in compliance with GLP.The study included a preliminary concentration range-finding test, an initial mutation test and a confirmatory mutation test. Based on the results of the dose range-finding study, the substance was tested in the first mutation assay at concentrations of 100 to 5,000 μg/plate in the absence and presence of 5% (v/v) S9-mix in Salmonella typhimurium strains TA 98, TA1535 and TA1537. In the second mutation assay, the substance was tested at the same concentration range in the absence and presence of 10% (v/v) S9-mix in Salmonella typhimurium strains TA 98, TA100, TA1535, TA1537 and E. coli strain WP2uvrA. The bacterial background lawn was not reduced at any of the concentrations tested and no decrease in the number of revertants was observed. The test substance did not induce a dose-related, two-fold increase in the number of revertant (His+) colonies in each of the five tester strains in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. The negative and strain-specific control values were within laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Based on the findings of the study, it can be concluded that the substance was not mutagenic either in the presence or absence of metabolic activation under the conditions of a bacterial reverse mutation assay (Verspeek-Rip CM, 2004).
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