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EC number: 860-352-3 | CAS number: 1610350-91-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-07-07 to 2014-11-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2S)-2-amino-3-(4-{[bis(sodiooxy)phosphoryl]oxy}phenyl)propanoic acid
- EC Number:
- 860-352-3
- Cas Number:
- 1610350-91-8
- Molecular formula:
- C9H10NO6PNa2
- IUPAC Name:
- (2S)-2-amino-3-(4-{[bis(sodiooxy)phosphoryl]oxy}phenyl)propanoic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- - HIS operon (Salmonella typhimurium strains)
- TRP operon (Escherichia coli WP2 uvrA)
The strains are constructed to differentiate between base pair (E.coli WP2 uvrA, TA1535, TA100, TA102) and frameshift (TA1537, TA98) mutations.
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Aroclor-induced male Wistar rats
- method of preparation of S9 mix: Male Wistar rats were given a single intraperitoneal injection of Aroclor 1254 (500 mg/kg body weight) dissolved in Miglyol 812 oil. On day 5 to 7, they were sacrificed, the livers were removed and collected in ice-cooled sterilized beakers containing 0.15 M KCl. After homogenization the preparation was transferred to sterilized steel centrifuge tubes and spun al 9000 x g for 10 minutes al about 4°C and the supernatant fluid was decanted and transferred into sterilized and prccooled plastic tubes. The S9 was then frozen and stored in liquid nitrogen at -196°C.
- concentration or volume of S9 mix and S9 in the final culture medium:
S9: 0.1 mL (1st series) and 0.3 mL (2nd series)
- quality controls of S9: Every S9-batch is tested for its metabolic activity by the use of specific substrates, requiring different enzymes of the P450-isoenzyme family. The mutagenicity of 2-aminoanthracene, benzo[a]pyrene, and 3-methylcholanthrene is thus determined once for every S9-batch. - Test concentrations with justification for top dose:
- - 1st series: 5, 15.8, 50, 158, 500, 1580, 5000 µg/plate
- 2nd series: 50, 158, 500, 1580, 2810, 5000 µg/plate
A maximum concentration of 5000 µg/plate was selected as the maximum recommended concentration according to current regulatory guidelines (OECD, 1997). - Vehicle / solvent:
- - Vehicles/solvents used: DMSO (cumene hydroperoxide, 2-aminoanthracene, benzo[a]pyrene, 4-nitroquinoline-N-oxide), ethanol (9-aminoacridine), ultrapure water (daunomycin, sodium azide, test item)
- Justification for choice of solvent/vehicle: Preliminary solubility data indicated that the test item was water soluble. Based on these preliminary data, ultrapure water was selected as vehicle for the current experiment.
- Justification for percentage of solvent in the final culture medium: Since on the one hand organic solvents may have diverse effects on e.g. gene regulation and, on the other hand, high amounts of solvent will dilute the top agar, the maximum amount of solvent was limited to 100 µL per plate for water and DMSO. For ethanol, acetone and other organic solvents, 10 µL per plate was not exceeded.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ultrapure water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9, tested with TA 98, TA 100, and TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ultrapure water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: daunomycin
- Remarks:
- without S9, tested with TA 98, TA 100, and TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9, tested with TA 98, TA 100, and TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9, tested with TA 98, TA 100, and TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9, tested with TA 98, TA 100, TA 102 and TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9, tested with TA 98, TA 100, TA 102, TA 1537 and TA 1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cumene hydroperoxide
- Remarks:
- without S9, tested with TA 98, TA 100, and TA 1537
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 2-3 days at 36-38°C
METHODS FOR MEASUREMENTS OF GENOTOXICIY
mean numbers of revertants - Evaluation criteria:
- The assessment of test material-induced effects is dependent on the number of spontaneous revertants of each bacterial strain (solvent controls) and the increase in the number of revertants at the test material concentration which shows the highest number of colonies. Criteria, which are based upon the historical controls of the laboratory and statistical considerations are shown in table 1.
- Statistics:
- n.a.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation and time of the determination: The test material did not precipitate
STUDY RESULTS
- Concurrent vehicle negative and positive control data: See tables in "Attached background material"
Ames test:
- Signs of toxicity: The test item produced no signs of toxicity to the bacteria up to the highest concentration applied.
- Mean number of revertant colonies per plate and standard deviation: See tables in "Attached background material"
Applicant's summary and conclusion
- Conclusions:
- With and without addition of S9 mix as the external metabolizing system,the test item was not mutagenic in this in vitro gene mutation study in bacteria.
- Executive summary:
The test item was examined for its mutagenic activity in two series of in vitro microbial assays employing Salmonella typhimurium TA98, TA 100, TA 102, TA 1535 and TA 1537,and Escherichia coli WP2 uvrA as indicator organisms. The test material was tested directly and after metabolic activation by liver S9 mix obtained from rats pretreated with Aroclor 1254. Precipitation of the test material on the agar plates was not occurred. Toxicity to the bacteria was not observed.
The validity of the mutation assay can be assessed by the results obtained for the negative and positive controls. The negative control mutant frequencies were all in the regular range. Slight deviations from those values, if they occur, are accepted if they appear in only one test series and, furthermore, all other parameters of that series are in the regular range. The strain specific positive control test materials, namely daunomycin, sodium azide, 4-nitroquinolin-N-oxide, 9-aminoacridine, and cumene hydroperoxide in the absence of S9 mix, yielded the expected mutant frequencies that were greatly in excess of the negative controls. The genotype of the tester strains used was thus confirmed. 2-aminoanthracene and benzo[a]pyrene, which require metabolic activation, were strongly mutagenic. This indicates that the exogenous metabolizing system used in the present investigation (S9 mix) was functioning. Thus, the demands predetermined in the study protocol and in section 4 of this report have been met in total and the study is considered valid.
In both series of experiments, each performed with and without the addition of rat liver S9 mix as the external metabolizing system, the test item showed no relevant increase in the number of revertants of any bacterial strain. According to the criteria for negative and positive results predetermined in the study protocol, the test item was not mutagenic under the described experimental conditions.
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