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EC number: 231-151-2 | CAS number: 7440-42-8
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-03-21 to 2001-04-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study reliable without restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 1997-07-21
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 1999-01-25
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Boron
- EC Number:
- 231-151-2
- EC Name:
- Boron
- Cas Number:
- 7440-42-8
- Molecular formula:
- B
- IUPAC Name:
- borane
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Boron amorphous
- Physical state: brown powder
- Storage condition of test material: room temperature, dry
- Average particle size: 0.9 µm
- Specific surface area: 11.1 m^2/g
Constituent 1
Method
- Target gene:
- not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- First test (range finding): 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Second test (pre-incubation assay): 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: purified water containing 0.15% agar (prepared in-house)
- Justification for choice of solvent/vehicle: the test substance was insoluble in all compatible solvents at 50 mg/mL. Suspensions of the test substance were, therefore, prepared in purified water containing 0.15% agar (prepared in-house).
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- purified water containing 0.15% agar
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Positive control without metabolic activation; strains TA1535 (0.5 µg/plate) and TA100 (0.5 µg/plate)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- purified water containing 0.15% agar
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Positive control without metabolic activation; strain TA1537 (30 µg/plate)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- purified water containing 0.15% agar
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Positive control without metabolic activation; strain TA98 (1µg/plate)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- purified water containing 0.15% agar
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- furylfuramide
- Remarks:
- Positive control without metabolic activation; strain WP2uvrA/pKM101 (CM891) (0.05 µg/plate)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- purified water containing 0.15% agar
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2 - Aminoanthracene
- Remarks:
- Positive control with metabolic activation; strain WP2uvrA/pKM101 (CM891) (10 µg/plate)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- purified water containing 0.15% agar
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Positive control with metabolic activation; strains TA1537 (5 µg/plate), TA98 (5 µg/plate) and TA100 (5 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)(first test) and preincubation (second test)
NUMBER OF REPLICATIONS: three petri dishes were used for each concentration
NUMBER OF CELLS EVALUATED: the appearance of the background bacterial lawn was examined and revertant colonies counted using a Domino automated colony counter.
DETERMINATION OF CYTOTOXICITY
- Method: any toxic effects of the test substance would be detected by a substantial reduction in revertant colony counts or by the absence of a complete background bacterial lawn.
CHECK FOR STERILITY:
Plates were prepared without addition of bacteria in order to assess the sterility of the test substance, S9 mix and sodium phosphate buffer.
VALIDITY OF TEST
For a test to be considered valid the mean of the solvent/vehicle control revertant colony numbers for each strain should lie within the 99% confidence limits of the current historical control range of the laboratory unless otherwise justified. Also, the positive control compounds must cause at least a doubling of mean revertant colony numbers over the negative control. - Evaluation criteria:
- The mean number of revertant colonies for each treatment group was compared with those obtained for the solvent/vehicle control groups. The mutagenic activity of a test substance was assessed by applying the following criteria:
a) If treatment with a test substance produces an increase in revertant colony numbers of at least twice the concurrent solvent/vehicle controls, with some evidence of a positive dose-relationship, in two separate experiments, with any bacterial strain either in the presence or absence of S9 mix, the test substance will be considered to show evidence of mutagenic activity in this test system. No statistical analysis will be performed.
b) If treatment with a test substance does not produce reproducible increases of at least 1.5 times the concurrent solvent/vehicle controls in either mutation test, the test substance will be consideredto show no evidence of mutagenic activity in this test system. No statistical analysis will be performed.
c) If the results obtained fail to satisfy the criteria for a clear "positive" or "negative" response given in paragraphs a) and b), even after the additional testing outlined in the mutation test procedure, the test data may be subjected to analysis to determine the statistical significance of any increases in revertant colony numbers. The statistical procedures used will be those described by Mahon et al. (1989)* and will usually be analysis of variance followed by Dunnett's test. Biological significance should always be considered along with statistical significance. It should be noted that it is acceptable to conclude an equivocal response if no clear results can be obtained.
*Reference:
Mahon, G. A. T. et al. (1989) Analysis of data from microbial colony assays in Kirkland, D. J. (Ed.). UKEMS Sub-committee on Guidelines for Mutagenicity Testing. Report. Part III. Statistical Evaluation of Mutagenicity Test Data, pp. 26 - 65. Cambridge University Press, Cambridge. - Statistics:
- Please refer to "Evaluation criteria" above
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- 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
- Positive controls validity:
- valid
- Additional information on results:
- The absence of colonies on sterility check plates confirmed the absence of microbial contamination.
The total colony counts on nutrient agar plates confirmed the viability and high cell density of the cultures of the individual organisms.
The mean revertant colony counts for the vehicle controls were within the 99% confidence limits of the current historical control range of the laboratory. Appropriate positive control chemicals (with S9 mix where required) induced substantial increases in revertant colony numbers with all strains, confirming sensitivity of the cultures and activity of the S9 mix.
RESULTS FIRST TEST
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to boron amorphous at any concentration in either the presence or absence of S9 mix.
No visible thinning of the background lawn of non-revertant cells was obtained following exposure to boron amorphous. A maximum exposure concentration of 5000 µg/plate was, therefore, selected for use in the second test.
RESULTS SECOND TEST
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to boron amorphous at any concentration in either the presence or absence of S9 mix.
No visible thinning of the background lawn of non-revertant cells was obtained following exposure to boron amorphous. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that, under the test conditions employed, boron amorphous showed no evidence of mutagenic activity in this bacterial system.
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