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EC number: 613-145-5 | CAS number: 63139-21-9
- 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:
- 2006-12-04 to 2007-02-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2000-06-08
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (4-ethylphenyl)boronic acid
- EC Number:
- 613-145-5
- Cas Number:
- 63139-21-9
- Molecular formula:
- C8 H11 B O2
- IUPAC Name:
- (4-ethylphenyl)boronic acid
- Test material form:
- solid
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, TA 1535, TA 100, TA 102) and frameshift (TA 1537, TA 98) mutations.
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- 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:
- 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: 0.5 mL of S9 mix in the final medium (total: 2.61 mL), 10% of S9 in the S9 mix (1st series) and 30% of S9 in the S9 mix (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 per plate
2nd series: 158, 500, 889, 1580, 2810 µg per plate;
A maximum concentration of 5000 µg/plate was selected as the maximum recommended concentration according to current regulatory guidelines (OECD, EEC). - Vehicle / solvent:
- - Vehicles/solvents used: DMSO (test item, cumene hydroperoxide, 2-aminoanthracene, benzo[a]pyrene, 4-nitroquinoline-N-oxide), ethanol (9-aminoacridine), ultrapure water (daunomycin, sodium azide)
- Justification for choice of solvent/vehicle: Solubility up to 1580 ug/plate
- 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:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9, used for TA 102 (10 µg/plate)
- 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, used for TA 98, TA100 and TA 1535 (2 µg/plate), TA 1537 (5 µg/plate) E.coli WP2 uvrA (10 µg/plate)
- 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, used for E.coli WP2 uvrA (2 µg/plate)
- 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, used for TA 1537 (50 µg/plate)
- 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, used for TA 102 (200 µg/plate)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- H2O
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9, used for TA 100 and TA1535 (2 µg/plate)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- H2O
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Daunomycin
- Remarks:
- without S9, used for TA 98 (1 µg/plate)
- 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:
- Plate incorporation method
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 2-3 days
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Background growth inhibition
- Reduction in the number of spontaneous revertants
METHODS FOR MEASUREMENTS OF GENOTOXICIY
Scoring of revertants colonies using an Artek MiniCount colony counter or manually - 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:
- cytotoxicity
- 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:
- cytotoxicity
- 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:
- cytotoxicity
- 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:
- cytotoxicity
- 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:
- cytotoxicity
- 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:
- cytotoxicity
- 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: Precipitation of the test material on the agar plates occurred at concentrations > 1580 µg/plate until the end of the experiment.
STUDY RESULTS
- Concurrent vehicle negative and positive control data: See "Attached background material"
Ames test:
- Signs of toxicity: Cytotoxic effects to the bacteria were observed at concentrations > 2810 µg/plate
- Mean number of revertant colonies per plate and standard deviation: See "Attached background material"
HISTORICAL CONTROL DATA
- Positive historical control data: See "Any other information on results incl. tables"
- Negative (solvent/vehicle) historical control data: See "Any other information on results incl. tables"
Any other information on results incl. tables
Table 2: According to the publications of Levin et al. (1982) and Kier et al. (1986) and the historical controls of the laboratory, usually the following mean numbers of revertants are acceptable as negative (or solvent) controls for the bacterial strains used:
TA 98: |
15-60 |
TA 1535: |
3-37 |
TA 100: |
75-200 |
TA 1537: |
4-31 |
TA 102: |
200-450 |
E.coli WP2 uvrA: |
10-70 |
Applicant's summary and conclusion
- Conclusions:
- With and without addition of S9 mix as the external metabolizing system, the test item was not mutagenic under the experimental conditions described.
- Executive summary:
The investigations for the mutagenic potential of the test item were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 102, TA 1535 and TA 1537, and Escherichia coti WP2 uvrA, The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. Two independent experimental series were performed. In the two series with S9 mix, 10 or 30 % S9 in the S9 mix were used in the 1st and 2nd series, respectively. The test item was dissolved in dimethyl sulfoxide (DMSO) and tested at concentrations ranging from 5.00 to 5000 µg/plate. Precipitation of the test material on the agar plates occurred at concentrations > 1580 µg/plate. Cytotoxic effects to the bacteria were observed at concentrations > 2810 µg/plate. Daunomycin, sodium azide, 9-aminoacridine, 4-nitroquinolin-N-oxide and cu-mene hydroperoxide served as strain specific positive control test materials in the absence of S9 mix. 2-Aminoanthracene and benzo[a]pyrene were used for testing the bacteria and the activity of the S9 mix. Each treatment with the test materials used as positive controls led to a clear increase in revertant colonies, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used. With and without addition of S9 mix as the external metabolizing system, the test item was not mutagenic under the experimental conditions described.
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