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EC number: 231-569-5 | CAS number: 7637-07-2
- 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:
- 28 April 2010 to 11 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to internationally accepted guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- 13319-75-0
- IUPAC Name:
- 13319-75-0
- Reference substance name:
- Boron trifluoride dihydrate
- IUPAC Name:
- Boron trifluoride dihydrate
- Details on test material:
- - Name of test material (as cited in study report): Boron Trifluoride Dihydrate
- Physical state: Colourless liquid
- Analytical purity: 66.0% BF3 content; 44.0% water content
- Purity test date: 10 November 2009
- Lot/batch No.: R.F. L.A.P. 154.19
- Expiration date of the lot/batch: November 2014
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
Method
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:
- Rat liver homogenate S9 mix
- Test concentrations with justification for top dose:
- 5, 15, 50, 150, 500, 1500, 5000 µg per plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: test substance soluble in water
Controlsopen allclose all
- Untreated negative controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- sodium azide (2 µg/plate for strains TA100 and TA1535), 9-aminoacridine (50 μg/plate for strain TA1537) , 2-nitrofluorene (2 μg/plate for strain TA98), 4-nitroquinoline-N-oxide 2 μg/plate for strain WP2 uvrA (pKM101)
- Remarks:
- Absence of S9 mix
- Untreated negative controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2-Aminoanthracene
- Remarks:
- 5 μg/plate for strains TA100 and TA1535, 10 μg/plate for strain WP2 uvrA (pKM101); presence of S9 mix
- Untreated negative controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- benzo(a)pyrene (5 μg/plate for strains TA98 and TA1537)
- Remarks:
- Presence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 per concentration - Evaluation criteria:
- For a test to be considered valid, the mean of the vehicle control revertant colony numbers for each strain should lie within or close to the 99% confidence limits of the current historical control range of the laboratory unless otherwise justified by the Study Director. The historical range is maintained as a rolling record over a maximum of five years. Also, the positive control compounds must induce an increase in mean revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls. Mean viable cell counts in the 10-hour bacterial cultures must be at least 10E9/mL.
If exposure to a test substance produces a reproducible increase in revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls, with some evidence of a positive dose-response relationship, it is considered to exhibit mutagenic activity in this test system. No statistical analysis is performed.
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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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 obtained in the presence of metabolic activation: test 1 | ||||||
Strain | Addition | Concentration per plate | Mean revertants per plate | Standard Deviation | Fold increase relative to vehicle | Individual revertant |
colony counts | ||||||
TA98 | Water | 28.3 | 0.6 | 28, 29, 28 | ||
Boron Trifluoride Dihydrate | 5 µg | 35.7 | 5.9 | 1.3 | 40, 29, 38 | |
15 µg | 34.3 | 3.5 | 1.2 | 34, 31, 38 | ||
50 µg | 33.3 | 4.0 | 1.2 | 29, 37, 34 | ||
150 µg | 27.3 | 1.5 | 1.0 | 29, 26, 27 | ||
500 µg | 32.7 | 5.5 | 1.2 | 38, 33, 27 | ||
1500 µg | 28.3 | 1.2 | 1.0 | 29, 29, 27 | ||
5000 µg | 28.7 | 0.6 | 1.0 | 29, 28, 29 | ||
TA100 | Water | 168.0 | 8.2 | 177, 161, 166 | ||
Boron Trifluoride Dihydrate | 5 µg | 162.0 | 8.9 | 1.0 | 159, 155, 172 | |
15 µg | 153.0 | 17.4 | 0.9 | 133, 165, 161 | ||
50 µg | 164.7 | 11.0 | 1.0 | 154, 164, 176 | ||
150 µg | 145.3 | 24.9 | 0.9 | 164, 117, 155 | ||
500 µg | 138.3 | 18.9 | 0.8 | 160, 130, 125 | ||
1500 µg | 149.0 | 28.5 | 0.9 | 178, 121, 148 | ||
5000 µg | 136.7 | 16.0 | 0.8 | 153, 121, 136 | ||
TA1535 | Water | 20.7 | 4.2 | 16, 24, 22 | ||
Boron Trifluoride Dihydrate | 5 µg | 20.3 | 0.6 | 1.0 | 20, 21, 20 | |
15 µg | 20.7 | 4.9 | 1.0 | 24, 23, 15 | ||
50 µg | 17.7 | 2.5 | 0.9 | 20, 18, 15 | ||
150 µg | 19.3 | 1.2 | 0.9 | 20, 18, 20 | ||
500 µg | 18.7 | 2.3 | 0.9 | 16, 20, 20 | ||
1500 µg | 19.3 | 2.9 | 0.9 | 16, 21, 21 | ||
5000 µg | 16.7 | 0.6 | 0.8 | 16, 17, 17 | ||
TA1537 | Water | 10.7 | 1.2 | 12, 10, 10 | ||
Boron Trifluoride Dihydrate | 5 µg | 11.0 | 4.0 | 1.0 | 15, 7, 11 | |
15 µg | 15.3 | 2.9 | 1.4 | 17, 17, 12 | ||
50 µg | 10.7 | 5.5 | 1.0 | 11, 5, 16 | ||
150 µg | 11.7 | 0.6 | 1.1 | 12, 12, 11 | ||
500 µg | 11.0 | 1.7 | 1.0 | 12, 12, 9 | ||
1500 µg | 9.0 | 3.0 | 0.8 | 9, 6, 12 | ||
5000 µg | 10.3 | 1.2 | 1.0 | 11, 11, 9 | ||
WP2 uvrA | Water | 129.7 | 14.6 | 132, 114, 143 | ||
(pKM101) | Boron Trifluoride Dihydrate | 5 µg | 123.3 | 7.1 | 1.0 | 122, 117, 131 |
15 µg | 127.3 | 8.1 | 1.0 | 120, 136, 126 | ||
50 µg | 134.7 | 5.8 | 1.0 | 128, 138, 138 | ||
150 µg | 117.0 | 2.6 | 0.9 | 115, 120, 116 | ||
500 µg | 113.3 | 18.6 | 0.9 | 94, 131, 115 | ||
1500 µg | 128.0 | 8.2 | 1.0 | 137, 121, 126 | ||
5000 µg | 103.0 | 10.8 | 0.8 | 100, 115, 94 | ||
TA98 | 2NF | 2 µg | 220.7 | 27.5 | 7.8 | 248, 221, 193 |
TA100 | NaN3 | 2 µg | 493.0 | 74.0 | 2.9 | 557, 510, 412 |
TA1535 | NaN3 | 2 µg | 1130.7 | 173.7 | 54.7 | 1259, 1200, 933 |
TA1537 | AAC | 50 µg | 1158.7 | 54.3 | 108.6 | 1189, 1191, 1096 |
WP2 uvrA (pKM101) | NQO | 2 µg | 1869.7 | 74.6 | 14.4 | 1793, 1874, 1942 |
Results obtained in the presence of metabolic activation: test 1
Strain | Addition | Concentration per plate | Mean revertants per plate | Standard Deviation | Fold increase relative to vehicle | Individual revertant |
colony counts | ||||||
TA98 | Water | 42.3 | 3.1 | 39, 45, 43 | ||
Boron Trifluoride Dihydrate | 5 µg | 46.7 | 4.0 | 1.1 | 51, 43, 46 | |
15 µg | 43.3 | 5.7 | 1.0 | 48, 37, 45 | ||
50 µg | 49.3 | 6.5 | 1.2 | 49, 56, 43 | ||
150 µg | 39.3 | 7.2 | 0.9 | 31, 44, 43 | ||
500 µg | 44.7 | 1.5 | 1.1 | 43, 46, 45 | ||
1500 µg | 39.0 | 6.6 | 0.9 | 38, 46, 33 | ||
5000 µg | 42.7 | 2.5 | 1.0 | 43, 45, 40 | ||
TA100 | Water | 197.3 | 10.1 | 209, 191, 192 | ||
Boron Trifluoride Dihydrate | 5 µg | 195.7 | 32.6 | 1.0 | 232, 169, 186 | |
15 µg | 176.0 | 45.2 | 0.9 | 167, 136, 225 | ||
50 µg | 183.3 | 23.6 | 0.9 | 175, 210, 165 | ||
150 µg | 206.7 | 32.5 | 1.0 | 232, 218, 170 | ||
500 µg | 186.3 | 10.7 | 0.9 | 192, 174, 193 | ||
1500 µg | 179.3 | 22.9 | 0.9 | 161, 172, 205 | ||
5000 µg | 195.3 | 11.7 | 1.0 | 185, 208, 193 | ||
TA1535 | Water | 23.7 | 3.1 | 27, 21, 23 | ||
Boron Trifluoride Dihydrate | 5 µg | 17.3 | 0.6 | 0.7 | 17, 18, 17 | |
15 µg | 18.0 | 1.7 | 0.8 | 20, 17, 17 | ||
50 µg | 19.7 | 1.5 | 0.8 | 18, 21, 20 | ||
150 µg | 18.7 | 2.9 | 0.8 | 17, 22, 17 | ||
500 µg | 19.7 | 3.5 | 0.8 | 23, 20, 16 | ||
1500 µg | 19.7 | 4.5 | 0.8 | 24, 20, 15 | ||
5000 µg | 21.0 | 1.7 | 0.9 | 20, 23, 20 | ||
TA1537 | Water | 30.7 | 2.5 | 31, 33, 28 | ||
Boron Trifluoride Dihydrate | 5 µg | 27.0 | 7.5 | 0.9 | 26, 20, 35 | |
15 µg | 24.3 | 2.3 | 0.8 | 27, 23, 23 | ||
50 µg | 32.3 | 5.1 | 1.1 | 28, 31, 38 | ||
150 µg | 28.3 | 2.5 | 0.9 | 31, 28, 26 | ||
500 µg | 29.0 | 9.2 | 0.9 | 39, 21, 27 | ||
1500 µg | 29.0 | 3.5 | 0.9 | 27, 27, 33 | ||
5000 µg | 25.7 | 2.5 | 0.8 | 26, 28, 23 | ||
WP2 uvrA | Water | 144.3 | 19.7 | 152, 122, 159 | ||
(pKM101) | Boron Trifluoride Dihydrate | 5 µg | 153.0 | 17.8 | 1.1 | 159, 133, 167 |
15 µg | 147.0 | 14.2 | 1.0 | 131, 152, 158 | ||
50 µg | 144.0 | 21.7 | 1.0 | 131, 132, 169 | ||
150 µg | 141.0 | 9.5 | 1.0 | 142, 150, 131 | ||
500 µg | 147.7 | 13.3 | 1.0 | 163, 141, 139 | ||
1500 µg | 149.7 | 6.8 | 1.0 | 152, 142, 155 | ||
5000 µg | 137.3 | 5.1 | 1.0 | 136, 143, 133 | ||
TA98 | B[a]P | 5 µg | 225.0 | 43.9 | 5.3 | 273, 187, 215 |
TA100 | AAN | 5 µg | 2877.3 | 645.7 | 14.6 | 3324, 3171, 2137 |
TA1535 | AAN | 5 µg | 410.0 | 45.1 | 17.3 | 453, 414, 363 |
TA1537 | B[a]P | 5 µg | 148.3 | 8.1 | 4.8 | 154, 152, 139 |
WP2 uvrA (pKM101) | AAN | 10 µg | 465.7 | 3.5 | 3.2 | 469, 462, 466 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that Boron Trifluoride Dihydrate showed no evidence of mutagenic activity in this bacterial system under the test conditions employed. - Executive summary:
In this in vitro assessment of the mutagenic potential of Boron Trifluoride Dihydrate (OECD 473, GLP) histidine-dependent auxotrophic mutants ofSalmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, and a tryptophan-dependent mutant ofEscherichia coli, strain WP2 uvrA (pKM101), were exposed to Boron Trifluoride Dihydrate diluted in water. Water was also used as a negative control.
Two independent mutation tests were performed in the presence and absence of liver preparations (S9 mix) from rats treated with phenobarbital and 5,6-benzoflavone. The first test was a standard plate incorporation assay; the second included a pre-incubation stage.
Concentrations of Boron Trifluoride Dihydrate up to 5000 µg/plate were tested.
No signs of toxicity were observed towards the tester strains in the first mutation test. Toxicity (observed as slight thinning of the background lawn of non-revertant colonies, together with a reduction in revertant colony numbers) was seen in all strains following exposure to Boron Trifluoride Dihydrate at 5000 µg/plate in the second mutation test.
No evidence of mutagenic activity was seen at any concentration of Boron Trifluoride Dihydrate in either mutation test.
The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. The mean revertant colony counts for the vehicle controls were within or close to the 99% confidence limits of the current historical control range of the laboratory.
In conclusion Boron Trifluoride Dihydrate showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.
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