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EC number: 234-514-3 | CAS number: 12007-60-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Oct 2017 until the 22 Nov 2017.
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dilithium tetraborate
- EC Number:
- 234-514-3
- EC Name:
- Dilithium tetraborate
- Cas Number:
- 12007-60-2
- Molecular formula:
- B4Li2O7
- IUPAC Name:
- dilithium tetraborate
- Test material form:
- solid: bulk
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 MIX
- Test concentrations with justification for top dose:
- In the dose range finding test eight concentrations,
1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 µg/plate were tested in triplicate using TA100 and the WP2uvrA, both with and without S9-mix.
The highest concentration of Dilithium tetraborate used in the subsequent mutation assay was 5000 µg/plate. At least five different doses (increasing with approximately half-log steps) of the test item were tested in triplicate in each strain in the absence and presence of S9-mix. The first experiment was a direct plate assay and the second experiment was a pre-incubation assay. - Vehicle / solvent:
- Milli-Q water
Controls
- Untreated negative controls:
- yes
- Remarks:
- Milli-Q water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
METHOD OF APPLICATION: Agar plates
DURATION
- Preincubation period: 30 ± 2 minutes
- Exposure duration: 48 ± 4 h
- Fixation time (start of exposure up to fixation or harvest of cells):
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
Cytotoxicity, as evidenced by a decrease in the number of revertants and/or a reduction of the bacterial background lawn was observed in tester strains TA1535 and TA1537 (absence of S9-mix). No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed in the other tester strains.
METABOLIC ACTIVATION SYSTEM
Rat liver microsomal enzymes (S9 homogenate) were prepared from male Sprague Dawley rats that had been injected intraperitoneally with Aroclor 1254 (500 mg/kg body weight). Each S9 batch was characterized with the mutagens benzo-(a)-pyrene (Sigma) and
2-aminoanthracene, which require metabolic activation, in tester strain TA100 at concentrations of 5 µg/plate and 2.5 µg/plate, respectively.
The negative control (vehicle) and relevant positive controls were concurrently tested in each strain in the presence and absence of S9-mix.- Evaluation criteria:
- A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The bacterial lawn was slightly reduced
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The bacterial lawn was slightly reduced
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- 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:
- valid
- Positive controls validity:
- valid
- Key result
- 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:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- 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:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the first mutation experiment, the test item was tested up to concentrations of 5000 µg/plate in the strains TA1535, TA1537 and TA98. Dilithium tetraborate did not precipitate on the plates at this dose level. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed. In all tester strains, no increase in the number of revertants was observed.Precipitation of Dilithium tetraborate on the plates was not observed at the start or at the end of the incubation period in any tester strain.
In the second mutation experiment, the test item was tested up to concentrations of 5000 µg/plate in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA in the pre-incubation assay. Dilithium tetraborate did not precipitate on the plates at this dose level. Cytotoxicity, as evidenced by a decrease in the number of revertants and/or a reduction of the bacterial background lawn was observed in tester strains TA1535 and TA1537 (absence of S9-mix).
In tester strain TA100, the test item induced up to 2.3-fold increases in the number of revertant colonies compared to the solvent control in the presence of S9-mix. In all other tester strains, no increase in the number of revertants was observed. The results in TA100 are therefore considered equivocal.
The negative control values were within the laboratory historical control data ranges. The strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly, except the response for WP2uvrA, absence of S9-mix in the second experiment. The results in TA100 are therefore considered equivocal. - Remarks on result:
- other:
- Remarks:
- Note: The number of revertant colonies was within the historical control data for all concentrations
Any other information on results incl. tables
Table1
Experiment 1: Mutagenic Response of Dilithium tetraborate in theSalmonella
typhimuriumReverse Mutation Assay
(µg/plate) |
|
||
|
|
|
|
Without S9-mix
Positive control |
838 |
± |
27 |
|
1028 |
± |
50 |
|
1001 |
± |
37 |
|
Solvent control |
8 |
± |
3 |
|
3 |
± |
3 |
|
11 |
± |
3 |
|
188 |
11 |
± |
3 |
|
6 |
± |
2 |
|
16 |
± |
6 |
|
375 |
11 |
± |
4 |
|
4 |
± |
4 |
|
11 |
± |
4 |
|
750 |
11 |
± |
3 |
|
6 |
± |
2 |
|
13 |
± |
7 |
|
1500 |
7 |
± |
3 |
|
4 |
± |
1 |
|
14 |
± |
5 |
|
3000 |
5 |
± |
5 |
|
3 |
± |
2 |
n |
12 |
± |
5 |
|
5000 |
6 |
± |
5 |
NP n |
0 |
± |
0 |
NP a |
17 |
± |
4 |
NP n |
|
|
|
|
|
|
|
|
|
|
|
|
|
With S9-mix1
Positive control |
277 |
± |
21 |
|
421 |
± |
22 |
|
1043 |
± |
21 |
|
Solvent control |
8 |
± |
2 |
|
4 |
± |
1 |
|
16 |
± |
5 |
|
188 |
9 |
± |
4 |
|
6 |
± |
2 |
|
15 |
± |
1 |
|
375 |
11 |
± |
2 |
|
4 |
± |
4 |
|
17 |
± |
2 |
|
750 |
15 |
± |
5 |
|
4 |
± |
1 |
|
14 |
± |
5 |
|
1500 |
14 |
± |
2 |
|
5 |
± |
3 |
|
18 |
± |
6 |
|
3000 |
10 |
± |
3 |
|
3 |
± |
0 |
n |
16 |
± |
7 |
|
5000 |
8 |
± |
2 |
NP n |
0 |
± |
0 |
NP a |
18 |
± |
2 |
NP n |
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
Plate incorporation assay (5% S9) |
NP |
No precipitate |
a |
Bacterial background lawn absent |
n |
Normal bacterial background lawn |
Table2
Experiment 1A: Mutagenic Response of Dilithium tetraborate in theSalmonella
typhimuriumReverse Mutation Assay
(µg/plate) |
|
||
|
|
|
|
Without S9-mix
Positive control |
566 |
± |
35 |
|
|
|
|
|
|
|
|
|
Solvent control |
5 |
± |
4 |
|
|
|
|
|
|
|
|
|
188 |
6 |
± |
2 |
|
|
|
|
|
|
|
|
|
375 |
5 |
± |
3 |
|
|
|
|
|
|
|
|
|
750 |
6 |
± |
3 |
|
|
|
|
|
|
|
|
|
1500 |
0 |
± |
0 |
a |
|
|
|
|
|
|
|
|
3000 |
6 |
± |
3 |
|
|
|
|
|
|
|
|
|
5000 |
4 |
± |
4 |
n NP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
With S9-mix1
Positive control |
378 |
± |
21 |
|
|
|
|
|
|
|
|
|
Milli-Q water |
6 |
± |
2 |
|
|
|
|
|
|
|
|
|
188 |
4 |
± |
5 |
|
|
|
|
|
|
|
|
|
375 |
8 |
± |
4 |
|
|
|
|
|
|
|
|
|
750 |
9 |
± |
6 |
|
|
|
|
|
|
|
|
|
1500 |
0 |
± |
0 |
a |
|
|
|
|
|
|
|
|
3000 |
4 |
± |
3 |
|
|
|
|
|
|
|
|
|
5000 |
3 |
± |
3 |
n NP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
Plate incorporation assay (5% S9) |
NP |
No precipitate |
a |
Bacterial background lawn absent |
n |
Normal bacterial background lawn |
Table 3
Experiment 2: Mutagenic Response of Dilithium tetraborate in theSalmonella
typhimuriumReverse Mutation Assay and in theEscherichia coliReverse
Mutation Assay
(µg/plate) |
|
||||
|
|
|
|
|
|
Without S9-mix
Positive control |
1019 |
± |
61 |
|
190 |
± |
55 |
|
1356 |
± |
31 |
|
602 |
± |
111 |
|
75 |
± |
18 |
|
Solvent control |
9 |
± |
1 |
|
4 |
± |
4 |
13 |
± |
7 |
|
103 |
± |
14 |
|
22 |
± |
10 |
|
|
188 |
12 |
± |
2 |
|
4 |
± |
1 |
|
10 |
± |
1 |
|
104 |
± |
24 |
|
26 |
± |
11 |
|
375 |
8 |
± |
4 |
|
5 |
± |
2 |
|
15 |
± |
4 |
|
112 |
± |
12 |
|
22 |
± |
6 |
|
750 |
9 |
± |
6 |
|
6 |
± |
5 |
|
14 |
± |
3 |
|
111 |
± |
25 |
|
29 |
± |
7 |
|
1500 |
12 |
± |
4 |
|
4 |
± |
1 |
|
14 |
± |
5 |
|
117 |
± |
20 |
|
38 |
± |
6 |
|
3000 |
5 |
± |
2 |
n |
4 |
± |
1 |
n |
10 |
± |
5 |
|
165 |
± |
8 |
|
23 |
± |
4 |
|
5000 |
7 |
± |
2 |
s NP |
2 |
± |
1 |
s NP |
12 |
± |
4 |
n NP |
178 |
± |
22 |
n NP |
22 |
± |
8 |
n NP |
With S9-mix1
Positive control |
171 |
± |
16 |
|
108 |
± |
22 |
|
651 |
± |
67 |
|
1359 |
± |
383 |
|
597 |
± |
21 |
|
Solvent control |
12 |
± |
9 |
|
5 |
± |
1 |
|
15 |
± |
3 |
|
69 |
± |
13 |
|
29 |
± |
4 |
|
188 |
12 |
± |
10 |
|
3 |
± |
2 |
|
24 |
± |
8 |
|
69 |
± |
2 |
|
30 |
± |
1 |
|
375 |
8 |
± |
2 |
|
5 |
± |
2 |
|
14 |
± |
2 |
|
83 |
± |
11 |
|
31 |
± |
10 |
|
750 |
7 |
± |
0 |
|
4 |
± |
1 |
|
17 |
± |
2 |
|
99 |
± |
3 |
|
32 |
± |
4 |
|
1500 |
10 |
± |
4 |
|
5 |
± |
2 |
|
9 |
± |
1 |
|
108 |
± |
10 |
|
32 |
± |
4 |
|
3000 |
5 |
± |
2 |
|
3 |
± |
1 |
|
16 |
± |
3 |
|
142 |
± |
18 |
|
42 |
± |
10 |
|
5000 |
7 |
± |
4 |
n NP |
3 |
± |
2 |
n NP |
12 |
± |
2 |
n NP |
161 |
± |
21 |
n NP |
36 |
± |
7 |
n NP |
1 |
Pre-incubation assay (5% S9) |
NP |
No precipitate |
n |
Normal bacterial background lawn |
s |
Bacterial background lawn slightly reduced |
Applicant's summary and conclusion
- Conclusions:
- In an OECD TG 471 study dilithium tetraborate induced dose related increases in tester strain TA100 in the absence and presence of S9-mix in two independent experiments (2.0 and 2.3-fold), respectively. The number of revertant colonies was within the historical control data range for all concentrations, with the exception of the highest concentration in the presence of S9-mix which was just above the historical control data range.
The test result was equivocal in tester strain TA100 of the Salmonella typhimurium reverse mutation assay. However, the test item was not mutagenic in the other Salmonella typhimurium tester strains (TA1535, TA1537 or TA98) or the Escherichia coli reverse mutation assay using strain WP2uvrA. - Executive summary:
This OECD TG 471 in vitro study was used determine the potential of Dilithium tetraborate and/or its metabolites upto concentrations of 5000 µg/plate to induce reverse mutations at the histidine locus in several strains of Salmonella typhimurium (S. typhimurium; TA98, TA100, TA1535, and TA1537), and at the tryptophan locus ofEscherichiacoli(E. coli) strain WP2uvrA in the presence or absence of an exogenous mammalian metabolic activation system (S9).
The test result was equivocal in tester strain TA100 of the Salmonella typhimurium reverse mutation assay. However, the test item was not mutagenic in the other Salmonella typhimurium tester strains (TA1535, TA1537 or TA98) or the Escherichia coli reverse mutation assay using strain WP2uvrA.
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