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EC number: 236-337-7 | CAS number: 13308-51-5
- 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:
- 25 Feb - 01 Jun 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- Boron orthophosphate
- EC Number:
- 236-337-7
- EC Name:
- Boron orthophosphate
- Cas Number:
- 13308-51-5
- Molecular formula:
- BPO4
- IUPAC Name:
- boron(+3) cation phosphate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- his/trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Preliminary toxicity test:
- 156, 313, 625, 1250, 2500 and 5000 µg/plate (TA 98 and TA 1535 with and without metabolic activation)
Experiment I+II:
- 313, 625, 1250, 2500 and 5000 µg/plate (with and without metabolic activation) - Vehicle / solvent:
- - Vehicle/solvent used: distilled water
- Justification for choice of solvent: Distilled water was used as solvent, since this medium is not suspected of chemical reaction with the test substance and is compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9-mix: daunomycin (DM), sodium azide (NaN), ICR 191 acridine (ICR), 4-nitroquinoline-1-oxide (4-NQO); +S9-mix: 2-aminoanthracene (2-AA), benzo(a)pyrene (BaP)
- Remarks:
- DM (6 µg/plate: TA 98); NaN (1.5 µg/plate: TA 100, TA 1535); ICR (1 µg/plate: TA 1537); 4-NQO (2 µg/plate: E.coli WP2 uvrA); 2-AA (10 µg/plate: TA 98, TA 100, TA 1535, TA 1537; 50 µg/plate: E.coli WP2 uvrA); BaP (20 µg/plate: TA 98, TA 100)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 - 72 h
NUMBER OF REPLICATIONS: 3 plates for each test concentration and control
DETERMINATION OF CYTOTOXICITY
- A preliminary experiment was conducted with the test material in tester strains TA 98 and TA 1535 either in the presence or in the absence of metabolic activation to determine cytotoxicity and solubility of the test substance using concentrations of 156, 313, 625, 1250, 2500 and 5000 µg/plate.
- Method: Cytotoxicity is detected by reduction in the number of revertant colonies - Evaluation criteria:
- Means of individual plate counts (triplicates) were calculated for test solutions and controls. In general, a 2 or 2.5-fold increase in the number of revertant colonies per plate over the background (spontaneous revertant frequency) is used as a criterion to distinguish active mutagens from non-mutagenic materials. The presence of dose-response is a further criterion for mutagenic materials.
- Statistics:
- Mean values and standard deviation were calculated for each test and control concentration.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: 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
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Slight precipitations were seen in all test material concentrations which did not influence the results of the assay.
RANGE-FINDING/SCREENING STUDIES
As no relevant cytotoxicity was observed in the preliminary test (data not shown), the highest test concentration used in the main test was 5000 µg/plate.
ADDITIONAL INFORMATION ON CYTOTOXICITY
No signs of cytotoxicity are reported.
COMPARISON WITH HISTORICAL CONTROL DATA
The colony counts of negative and positive controls were in the dimensions of historical and literature data.
Any other information on results incl. tables
Table 1: Test results - Experiment I - Preincubation method
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
– |
0 |
79 ± 2 |
8 ± 0 |
13 ± 2 |
13 ± 4 |
8 ± 2 |
– |
313 |
87 ± 7 |
11 ± 2 |
10 ± 2 |
12 ± 1 |
6 ± 1 |
– |
625 |
69 ± 8 |
8 ± 2 |
13 ± 6 |
11 ± 4 |
6 ± 3 |
– |
1250 |
74 ± 6 |
7 ± 3 |
15 ± 2 |
11 ± 4 |
3 ± 1 |
– |
2500 |
89 ± 13 |
7 ± 5 |
11 ± 3 |
12 ± 5 |
4 ± 2 |
– |
5000 |
85 ± 8 |
8 ± 1 |
11 ± 4 |
15 ± 6 |
7 ± 3 |
Positive controls, –S9 |
Name |
NaN |
NaN |
4-NQO |
DM |
ICR |
Concentrations (μg/plate) |
1.5 |
1.5 |
2 |
6 |
1 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
499 ± 31 |
431 ± 26 |
839 ± 67 |
435 ± 95 |
2040 ± 59 |
|
+ |
0 |
68 ± 11 |
7 ± 2 |
10 ± 5 |
13 ± 3 |
4 ± 1 |
+ |
313 |
63 ± 6 |
6 ± 0 |
12 ± 2 |
17 ± 3 |
6 ± 1 |
+ |
625 |
59 ± 16 |
7 ± 1 |
12 ± 4 |
18 ± 4 |
4 ± 2 |
+ |
1250 |
68 ± 20 |
8 ± 4 |
11 ± 2 |
20 ± 5 |
5 ± 3 |
+ |
2500 |
70 ± 15 |
6 ± 2 |
11 ± 6 |
16 ± 2 |
4 ± 2 |
+ |
5000 |
72 ± 10 |
6 ± 4 |
10 ± 3 |
18 ± 2 |
4 ± 2 |
Positive controls, +S9 (10%) |
Name |
2-AA / BaP |
2-AA |
2-AA |
2-AA / BaP |
2-AA |
Concentrations (μg/plate) |
10 / 20 |
10 |
50 |
10 / 20 |
10 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1807 ± 11 / 584 ± 19 |
56 ± 7 |
316 ± 62 |
2068 ± 60 / 290 ± 79 |
182 ± 25 |
DM: daunomycin
NaN: sodium azide
ICR: ICR 191 acridine
4-NQO: 4-nitroquinoline-1-oxide
2-AA: 2-aminoanthracene
BaP: benzo(a)pyrene
Table 2: Test results - Experiment II - Plate incorporation method
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
– |
0 |
70 ± 12 |
8 ± 3 |
10 ± 5 |
29 ± 4 |
4 ± 1 |
– |
313 |
81 ± 6 |
6 ± 3 |
12 ± 6 |
18 ± 8 |
4 ± 3 |
– |
625 |
88 ± 13 |
8 ± 3 |
11 ± 1 |
17 ± 3 |
5 ± 1 |
– |
1250 |
81 ± 9 |
7 ± 2 |
13 ± 2 |
10 ± 3 |
6 ± 1 |
– |
2500 |
97 ± 12 |
6 ± 3 |
12 ± 3 |
17 ± 5 |
5 ± 2 |
– |
5000 |
79 ± 7 |
6 ± 3 |
14 ± 2 |
16 ± 4 |
4 ± 2 |
Positive controls, –S9 |
Name |
NaN |
NaN |
4-NQO |
DM |
ICR |
Concentrations (μg/plate) |
1.5 |
1.5 |
2 |
6 |
1 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
468 ± 37 |
385 ± 12 |
1185 ± 291 |
576 ± 99 |
82 ± 13 |
|
+ |
0 |
86 ± 12 |
4 ± 0 |
12 ± 6 |
12 ± 4 |
5 ± 2 |
+ |
313 |
72 ± 3 |
6 ± 3 |
12 ± 5 |
11 ± 6 |
4 ± 1 |
+ |
625 |
77 ± 4 |
7 ± 2 |
8 ± 3 |
22 ± 8 |
5 ± 2 |
+ |
1250 |
73 ± 10 |
5 ± 2 |
11 ± 2 |
19 ± 3 |
5 ± 1 |
+ |
2500 |
73 ± 16 |
7 ± 3 |
13 ± 2 |
14 ± 3 |
4 ± 2 |
+ |
5000 |
70 ± 5 |
5 ± 2 |
14 ± 1 |
12 ± 7 |
4 ± 2 |
Positive controls, +S9 (10%) |
Name |
2-AA / BaP |
2-AA |
2-AA |
2-AA / BaP |
2-AA |
Concentrations (μg/plate) |
10 / 20 |
10 |
50 |
10 / 20 |
10 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
856 ± 154 / 383 ± 9 |
45 ± 2 |
378 ± 48 |
1782 ± 201 / 136 ± 23 |
175 ± 49 |
DM: daunomycin
NaN: sodium azide
ICR: ICR 191 acridine
4-NQO: 4-nitroquinoline-1-oxide
2-AA: 2-aminoanthracene
BaP: benzo(a)pyrene
Table 3: Historical control data (negative control)
Strain |
MIN |
MAX |
MEAN |
SD |
N |
|||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
TA 98 |
13 |
21 |
54 |
65 |
29 |
38 |
16 |
19 |
5 |
5 |
TA 100 |
62 |
63 |
246 |
232 |
112 |
108 |
78 |
70 |
5 |
5 |
TA 1535 |
7 |
8 |
28 |
20 |
14 |
11 |
8 |
5 |
5 |
5 |
TA 1537 |
3 |
3 |
4 |
6 |
4 |
5 |
n.a. |
n.a. |
2 |
2 |
WP2 uvrA |
13 |
13 |
17 |
20 |
15 |
18 |
2 |
3 |
4 |
4 |
SD: standard deviation
n.a.: not applicable
N: number of studies
Table 4: Historical control data (positive control)
Strain |
Chemical |
MIN |
MAX |
N |
TA 98 |
2-Aminoanthracene |
135 |
>1000 |
5 |
Daunomycin |
198 |
>500 |
5 |
|
TA 100 |
2-Aminoanthracene |
326 |
>500 |
5 |
Sodium azide |
274 |
>500 |
5 |
|
TA 1535 |
2-Aminoanthracene |
67 |
>300 |
5 |
Sodium azide |
83 |
>300 |
5 |
|
TA 1537 |
2-Aminoanthracene |
107 |
210 |
2 |
ICR 191 Acridine |
126 |
283 |
2 |
|
WP2 uvrA |
2-Aminoanthracene |
251 |
407 |
4 |
4-Nitroquinoline-1-oxide |
756 |
1532 |
4 |
N: number of studies
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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