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EC number: 435-580-8 | CAS number: 56553-60-7
- 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 mammalian cells
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study with Boric acid comparable to OECD guideline with no or minor deviations having no influence on outcome. According to the ECHA guidance document the reliability was changed from 1 to 2 to reflect the fact that the study was conducted with a read-across substance.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Reference Type:
- publication
- Title:
- Responses of the L5178Y tk+/tk- mouse lymphoma cell forward mutation assay: III. 72 coded chemicals
- Author:
- McGregor, D. et al.
- Year:
- 1 988
- Bibliographic source:
- Environ. Molec. Mutagen. Vol. 12 (1988) 85-154
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Mouse lymphoma L5178Y/tk+/- assay in line with OECD 476, further information in Mitchell et al. (1988), Evaluation of the L5178Y Mouse Lymphoma Cell Mutagenesis Assay: Methods Used and Chemicals Evaluated. Environ. Mol. Mutagen. 12 (Suppl. 13): 1-18.
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Boric acid
- EC Number:
- 233-139-2
- EC Name:
- Boric acid
- Cas Number:
- 10043-35-3
- Molecular formula:
- BH3O3
- IUPAC Name:
- Boric acid
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Boric acid
- Supplier: Radian Corporation, USA
Constituent 1
Method
- Target gene:
- Thymidine kinase (TK) locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Fischer's medium supplemented with 2 mM l-glutamine, 110 ug/mL sodium pyruvate, 0.05% luronic F68, antibiotics, and heat-inactivated horse serum
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix prepared from Aroclor 1254-induced male Fischer 344 rats
- Test concentrations with justification for top dose:
- Experiment I:
Without S9 mix: 62.5, 125, 250, 500, 1000 µg/mL
With S9 mix: 2000, 3000, 4000, 5000 µg/mL
Experiment II:
Without S9 mix: 1000, 1800, 2600, 3400, 4200, 5000 µg/mL
With S9 mix: 1000, 2000, 3000, 4000, 5000 µg/mL
Experiment III:
Without S9 mix: 1000, 1800, 2600, 3400, 4200, 5000 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (Experiment I, without S9 mix), Fischer Medium
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- methylmethanesulfonate
- Remarks:
- methylmethanesulfonate (15 µg/mL); 3-methylcholanthrene (2.5 µg/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Exposure duration: 4 h
- Expression time (cells in growth medium): 48 h
- Selection time (if incubation with a selection agent): 10-12 day
SELECTION AGENT (mutation assays): trifluorothymidine
NUMBER OF REPLICATIONS: at least 2
DETERMINATION OF CYTOTOXICITY
- Method: loning efficiency; relative total growth
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results:
Nonactivation Trial: 1 Experiment Call: Inconclusive | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | Avg Mutant Frequency | ||
ug/mL | Efficiency | Growth | |||||
Vehicle Control | Dimethyl Sulfoxide | 0 | 63 | 110 | 119 | 63 | 58 |
69 | 102 | 98 | 48 | ||||
64 | 115 | 110 | 57 | ||||
67# | 73 | 130.5 | 65 | ||||
Test Chemical | Boric acid | 62.5 | 64 | 81 | 124 | 65 | 67 |
71 | 75 | 148 | 69 | ||||
125 | 50 | 92 | 123 | 83 | 69 | ||
55 | 113 | 93 | 56 | ||||
250 | 69 | 61 | 170 | 83 | 72 | ||
52 | 57 | 96 | 62 | ||||
500 | 55 | 80 | 135 | 82 | 67 | ||
71# | 107 | 110 | 52 | ||||
1000 | 60 | 69 | 131 | 73 | 66 | ||
60 | 71 | 105 | 59 | ||||
Positive Control | Methyl Methane Sulfonate | 15 | 26 | 29 | 344 | 438 | 435* |
37 | 28 | 484 | 432 | ||||
Nonactivation Trial: 2 Experiment Call: Negative and Non-Toxic | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | Avg Mutant Frequency | ||
uL/mL | Efficiency | Growth | |||||
Vehicle Control | Fischer Medium | 0 | 76 | 86 | 72 | 32 | 34 |
60 | 108 | 70 | 39 | ||||
89 | 123 | 83 | 31 | ||||
79 | 83 | 83 | 35 | ||||
Test Chemical | Boric acid | 1000 | 70 | 109 | 79 | 38 | 38 |
72 | 105 | 83 | 39 | ||||
1800 | 75 | 92 | 81 | 36 | 36 | ||
89# | 94 | 97 | 36 | ||||
2600 | 71 | 87 | 90 | 42 | 41 | ||
73 | 103 | 90 | 41 | ||||
3400 | 88# | 90 | 130.5 | 49 | 43 | ||
91 | 82 | 100 | 37 | ||||
4200 | 99 | 86 | 146 | 49 | 48 | ||
107 | 84 | 150 | 47 | ||||
5000 | 95 | 79 | 160 | 56 | 50 | ||
103 | 89 | 135 | 44 | ||||
Positive Control | Methyl Methane Sulfonate | 15 | 21 | 18 | 257 | 402 | 385* |
21 | 17 | 226 | 367 | ||||
Nonactivation Trial: 3 Experiment Call: Negative and Non-Toxic | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | Avg Mutant Frequency | ||
ug/mL | Efficiency | Growth | |||||
Vehicle Control | Fischer Medium | 0 | 95 | 109 | 51 | 18 | 24 |
89 | 126 | 84 | 31 | ||||
92 | 85 | 67 | 24 | ||||
78 | 79 | 54 | 23 | ||||
Test Chemical | Boric acid | 1800 | 100 | 77 | 66 | 22 | 21 |
86 | 92 | 52 | 20 | ||||
2600 | 115 | 78 | 64 | 19 | 22 | ||
113 | 90 | 86 | 25 | ||||
3400 | 78 | 81 | 44 | 19 | 25 | ||
85 | 83 | 78 | 31 | ||||
4200 | 87 | 64 | 68 | 26 | 24 | ||
93 | 80 | 62 | 22 | ||||
5000 | 104 | 62 | 62 | 20 | 22 | ||
112 | 55 | 83 | 25 | ||||
Positive Control | Methyl Methane Sulfonate | 15 | 54 | 31 | 228 | 140 | 166* |
42 | 27 | 244 | 192 | ||||
Induced S9 Trial: 1 Experiment Call: Negative and Non-Toxic | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | Avg Mutant Frequency | ||
ug/mL | Efficiency | Growth | |||||
Vehicle Control | Fischer Medium | 0 | 51 | 76 | 141 | 92 | 67 |
94 | 109 | 136 | 48 | ||||
78 | 107 | 121 | 52 | ||||
81 | 108 | 185 | 76 | ||||
Test Chemical | Boric acid | 2000 | 62 | 92 | 107 | 57 | 51 |
70 | 117 | 95 | 46 | ||||
3000 | 87 | 115 | 156 | 60 | 85 | ||
56 | 43 | 184 | 110 | ||||
4000 | 98 | 116 | 155 | 53 | 52 | ||
83 | 110 | 128 | 52 | ||||
5000 | 89 | 103 | 140 | 52 | 53 | ||
74 | 90 | 120 | 54 | ||||
Positive Control | 3-Methylcholanthrene | 2.5 | 66 | 72 | 340 | 171 | 182* |
62 | 67 | 358 | 193 | ||||
Induced S9 Trial: 2 Experiment Call: Negative and Non-Toxic | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | Avg Mutant Frequency | ||
ug/mL | Efficiency | Growth | |||||
Vehicle Control | Fischer Medium | 0 | 70 | 87 | 175 | 84 | 90 |
87# | 103 | 223.5 | 85 | ||||
96 | 104 | 285 | 99 | ||||
80 | 106 | 222 | 92 | ||||
Test Chemical | Boric acid | 1000 | 83# | 99 | 211.5 | 85 | 83 |
73 | 90 | 176 | 81 | ||||
2000 | 94# | 90 | 278 | 99 | 98 | ||
80 | 88 | 235 | 98 | ||||
3000 | 79 | 71 | 263 | 111 | 109 | ||
80 | 100 | 257 | 107 | ||||
4000 | 73# | 87 | 217.5 | 99 | 95 | ||
100 | 77 | 273 | 91 | ||||
5000 | 64# | 57 | 175.5 | 92 | 114 | ||
57 | 65 | 230 | 136 | ||||
Positive Control | 3-Methylcholanthrene | 2.5 | 59 | 34 | 867 | 488 | 536* |
45# | 38 | 787 | 583 |
r = rejected value due to quality control criteria
# = reduced sample size because of the loss of one culture dish due to contamination
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No significant increase in mutation of the TK locus in mouse lymphoma L5178Y cells was induced by Boric acid up the a concentration of 5000 µg/mL with and without metabolic activation by S9 mix. - Executive summary:
Boric acid was tested for inducing gene mutation in mammalian cells in a GLP study performed according to NTP protocol which is comparable to OECD guideline. Well maintained mouse lymphoma L5178Y cells were treated with boric acid up concentration of 5000 µg/mL with and without metabolic activation by a S9 mix for 4 hours. Since no toxicity and no increase in frequency was observed, boric acid was regarded to be non-mutagenic in mammalian cells.
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