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EC number: 237-262-2 | CAS number: 13709-94-9
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Remarks:
- reported in a publication
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- review article
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
see target record
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Remarks:
- reported in a publication
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- review article
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Review of literature data
- GLP compliance:
- no
- Analytical monitoring:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna Straus - Test type:
- semi-static
- Water media type:
- freshwater
- Total exposure duration:
- 21 d
- Hardness:
- 150 resp. 166 mg/L
- Test temperature:
- 20 resp. 19.2 °C
- pH:
- 6.7 - 8.1 resp. 7.1 - 8.7
- Details on test conditions:
- TEST SYSTEM
- Renewal rate of test solution (frequency/flow rate): 3 times weekly
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Lake Huron water resp. Carbon-filtered well water - Reference substance (positive control):
- not specified
- Duration:
- 21 d
- Dose descriptor:
- LC50
- Effect conc.:
- 52.2 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 395.5 mg/L BHO2.K
- Remarks:
- Lake Huron water, 20°C, pH 6.7 - 8.1, Hardness 150 mg/l
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 6.4 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 48.5 mg/L BHO2.K
- Remarks:
- Lake Huron water, 20°C, pH 6.7 - 8.1, Hardness 150 mg/l
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 13.6 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 103 mg/L BHO2.K
- Remarks:
- Lake Huron water, 20°C, pH 6.7 - 8.1, Hardness 150 mg/l
- Duration:
- 21 d
- Dose descriptor:
- LC50
- Effect conc.:
- 53.2 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 403.1 mg/L BHO2.K
- Remarks:
- Carbon-filtered well water, 19.2°C, pH 7.1 - 8.7, hardness 166 mg/L
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 6 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 45.5 mg/L BHO2.K
- Remarks:
- Carbon-filtered well water, 19.2°C, pH 7.1 - 8.7, hardness 166 mg/L / lowest available value
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 13 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 98.5 mg/L BHO2.K
- Remarks:
- Carbon-filtered well water, 19.2°C, pH 7.1 - 8.7, hardness 166 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The present information was based on a literature review of various suitable read-across substances all belonging to the group of borates, the relevant information on short term toxicity in daphnia magna was taken from boric acid. The lowest available chronic NOEC was 6 mg/L, which corresponds to 45.5 mg/l BHO2.K. So the available data shows that neither boron nor potassium metaborate needs to be classified as chronic aquatic toxic acc. Regulation 1272/2008, as all NOECs were above the limit value for classification of 1 mg/l for Non-rapidly degradable substances for which there are adequate chronic toxicity data available.
- Executive summary:
A literature review of showed that boron / potassium metaborate gave consistently NOECs > 1 mg/l.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Remarks:
- reported in a publication
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Review of literature data
- GLP compliance:
- no
- Analytical monitoring:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- other: Mosquito fish and Coho salmon, among others
- Details on test organisms:
- Mosquito fish (Gambusia affinis), adult females
Coho salmon (0. kisutch), under yearlings, 1.8-3.8 g - Test type:
- other: static & static renewal
- Water media type:
- other: freshwater and seawater
- Total exposure duration:
- 96 h
- Test temperature:
- 20-23°C or 22-26°C or 8°C
- pH:
- 5.4-7.3 or 8.6-9.1 (freshwater fish)
- Salinity:
- 28 promiile (seawater fish)
- Reference substance (positive control):
- not required
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Remarks:
- Mosquito fish, boric acid (TLm)
- Effect conc.:
- 978 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: corresponding to 7409.7 mg/L BHO2.K
- Remarks:
- 20-23°C; pH 5.4-7.3; turbidity 210-250 mg / liter, static
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Remarks:
- Mosquito fish, sodium tetraborate (TLm)
- Effect conc.:
- 408 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: corresponding to 3091.2 mg/L BHO2.K
- Remarks:
- 22-26°C; pH 8.6-9.1; turbidity 410-650 mg / liter, static
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Remarks:
- Coho Salmon, sodium metaborate
- Effect conc.:
- 40 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: corresponding to 303.1 mg/L BHO2.K
- Remarks:
- Seawater; 8°C; salinity 28 promille, static renewal (daily)
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The present information was based on a literature review of various suitable read-across substances all belonging to the group of borates. The lowest available LC50 value was 40 mg/L in an seawater organism, which corresponds to 303 mg/l BHO2.K, the other values were a magnitude higher. So the available data shows that potassium metaborate does not need to be classified as aquatic toxic acc. Regulation 1272/2008, as all LC50 values for potassium metaborate were calculated to be above the limit value for classification of 100 mg/l.
- Executive summary:
A literature review of showed that potassium metaborate gave consistently LC50 values > 100 mg/l.
- Reason / purpose for cross-reference:
- read-across source
- Remarks:
- target record
Reference
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- reported in a publication
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- review article, read-across substance
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Borates in general dissociate immediately upon contact with water and are converted rapidly into i.a. boric acid. This includes salts of boric acid (borates), metaboric acid (metaborates), hydrated borates (hydroborates) or borax. Boron compounds are highly soluble in water, and upon dissolving form essentially two species, undissociated boric acid (H3BO3) and borate anion (B(OH)4- [Soucek, Environmental Toxicology and Chemistry, Vol. 30, No. 8, pp. 1906–1914, 2011]. Orthoboric acid (Short: Boric acid, H3BO3) is a weak monobasic acid, which does not act as a proton donator but OH- acceptor (Lewis base) according to the following equilibrium:
B(OH)3 + 2 H2O ↔ B(OH)4- + H3O+ pKs = 9.2
Metaboric acid ((HBO2)n is formed during heating >90°C via intermolecular condensation while releasing a water molecule. Upon solubilisation in water, orthoboric acid is formed again. In diluted solutions practically only the monomeric H3BO3 are present [Riedel, Anorganische Chemie, de Gruyter, 1999]. A study by Zhu et al. [Zhu FY, Journal of Molecular Structure, Volume 1070, 24 July 2014, Pages 80-85] shows that the main borate species in aqueous KB(OH)4 solutions is B(OH)4−. This ion is in an equilibrium with H3BO3.
So in aqueous solutions at physiological and acidic pH, low concentrations of simple inorganic borates such as boric acid, disodium tetraborate decahydrate, disodium tetraborate pentahydrate, boric oxide and disodium octaborate tetrahydrate will predominantly exist as undissociated boric acid [WHO, Environmental Health Criteria 204, boron, World Health Organization, Geneva, 1998]. Also borax readily dissolves in water to form undissociated boric acid (H3BO3) and borate anion (B(OH)4-) [Soucek, 2011]. Most of the simple inorganic borates exist predominantly as undissociated boric acid in dilute aqueous solution at physiological pH [Hubbard SA, Biological Trace Element Research Vol. 66, 1998]. In aqueous solution, the metaborate ion is rapidly converted to the borate anion and the weakly dissociated boric acid by the sequential reactions shown by the following equations [Antia NJ, 1975, J. Fish. Res. Board Can. 32: 2487-2494]:
BO2- + 2 H2O → B(OH)4-
B(OH)4- + H3O+ ↔ B(OH)3 + 2 H2O
So if metaboric acid (resp. borates) is dissolved in water, orthoboric acid is formed [Riedel, 1999].
So summarizing, upon contact with water, potassium metaborate dissociates immediately into potassium and metaborate ions, whereas the latter is converted rapidly into boric acid.
As stated above, in diluted solutions and biologically relevant pH values, only undissociated boric acid is present, irrespective of which borate was dissolved in water, which so also applies to potassium metaborate. This is applicable for both ecotoxicity tests (usual limit concentration: 100 mg/l) as well as toxicological studies. Borates are readily absorbed orally in humans and animals [Hubbard, 1998], so the expected plasma levels are maximally as high as the applied dose, which still indicates that the boron species dissolved in plasma is H3BO3.
In consequence, data from boric acid and also all types of borates mentioned above, may be used to cover data gaps for potassium metaborate via read-across.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Target: Potassium metaborate, CAS 13709-94-9, EC 237-262-2, BKO2, MW = 81.9081 g/mol, SMILES [K+].[O-]B=O
Source: Boric acid / Orthoboric acid, CAS 10043-35-3, EC 233-139-2, H3BO3, MW = 61.83 g/mol, SMILES OB(O)O
Source: Borax / di-Sodium tetraborate decahydrate / sodium borate, CAS 1303-96-4, EC 603-411-9, Na2B4O7 *10H2O, MW = 381.365, SMILES (anhydrous) [Na+].[Na+].[O-]B(OB=O)OB([O-])OB=O
Source: Sodium tetraborate pentahydrate / Boron sodium oxide, pentahydrate, CAS 12179-04-3, EC 601-808-1, B4-O7.2Na.5H2-O, MW = 291.291 g/mol, SMILES B(=O)OB([O-])OB([O-])OB=O.O.O.O.O.O.[Na+].[Na+]
Source: Disodium octaborate tetrahydrate / Boron sodium oxide, tetrahydrate, CAS 12280-03-4, EC 602-894-3, B8Na2O13
Source: Sodium metaborate tetrahydrate / Boric acid, sodium salt, tetrahydrate, CAS 10555-76-7, EC 600-663-1
Source: Dipotassium tetraborate / boron potassium oxide, CAS 1332-77-0, EC 215-575-5, B4K2O7, MW = 233.4358, SMILES [K+].[K+].[O-]B([O-])[O-].[O-]B([O-])[O-].[O-]B([O-])[O-].[O-]B([O-])[O-]
Source: Diammonium tetraborate tetrahydrate / azane;2-hydroxy-4-[(4-hydroxy-1,3,2,4-dioxadiboretan-2-yl)oxy]-1,3,2,4-dioxadiboretane;tetrahydrate, CAS 10135-84-9; 12228-87-4, B4H16N2O11, MW = 263.371, SMILES B1(OB(O1)OB2OB(O2)O)O.N.N.O.O.O.O
Source: Zinc borate, hydrate / dodecaboron tetrazinc docosaoxide heptahydrate / Boron zinc hydroxide oxide / hexaboron dizinc undecaoxide, CAS 138265-88-0, EC 235-804-2, B12Zn4(OH)14O15, MW = 425.7 g/mol
There are no impurities known in neither target nor source chemical(s) which may affect the feasibility of the read-across approach.
3. ANALOGUE APPROACH JUSTIFICATION
As obvious in detail from the available data matrix, all borates exhibit similar (eco-)toxicological properties.
With regard to ecotoxicity, all available studies on various borates on fish, invertebrates, and algae, both short and long term, consistently indicate that, recalculated from the molecular weight, Potassium metaborate does not need to be classified as aquatic toxic (acute and chronic) according to Regulation 1272/2008 and amendments.
Similarly, with regard to human-relevant endpoints, Potassium metaborate does not need to be classified as acutely toxic, as consistently indicated by various borates in also various species.
Both boric acid and borax do not trigger classification as skin sensitizing, no further study data is available, However, Sodium Borate and Boric Acid are used in cosmetics in various functions, and no sensitizing reactions induced by these cosmetic products have been reported.
Borax and Boric acid were similarly non-mutagenic in the Ames Test, and the non-genotoxic potential is further supported by a negative chromosome aberration test. Both Borax and Boric however gave in different species, although via partially species-specific mode of actions, indication that they interfere via a certain threshold with reproduction. Proof via human data is however not available.
Further, all borates chosen for read-across, incl. the registered substance itself, are highly soluble in water, and upon dissolving form essentially two species, undissociated boric acid (H3BO3) and borate anion (B(OH)4-. Hence, read-across is further based on common breakdown products.
So summarizing, read-across is justified via similar (eco-)toxicological effects and common breakdown products.
4. DATA MATRIX
See attachment - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Review of literature data
- GLP compliance:
- no
- Analytical monitoring:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna Straus - Test type:
- static
- Water media type:
- freshwater
- Total exposure duration:
- 48 h
- Hardness:
- 150 resp. 166 mg/L
- Test temperature:
- 20 resp. 19.2 °C
- pH:
- 6.7 - 8.1 resp. 7.1 - 8.7
- Details on test conditions:
- TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Lake Huron water resp. Carbon-filtered well water - Reference substance (positive control):
- not specified
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 133 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 1007.7 mg/L BHO2.K
- Remarks:
- Lake Huron water, 20°C, pH 6.7 - 8.1, Hardness 150 mg/l
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 226 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 1712.3 mg/L BHO2.K
- Remarks:
- Carbon-filtered well water, 19.2°C, pH 7.1 - 8.7, hardness 166 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The present information was based on a literature review of various suitable read-across substances all belonging to the group of borates, the relevant information on short term toxicity in daphnia magna was taken from boric acid. The lowest available LC50 value was 133 mg/L, which corresponds to 1007 mg/l BHO2.K. So the available data shows that neither boron nor potassium metaborate needs to be classified as aquatic toxic acc. Regulation 1272/2008, as all LC50 values were above the limit value for classification of 100 mg/l.
- Executive summary:
A literature review of showed that boron / potassium metaborate gave consistently LC50 values > 100 mg/l.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Safety Assessment of Boron in Aquatic and Terrestrial Environments
- Author:
- Butterwick L, De Oude N, Raymond K
- Year:
- 1 989
- Bibliographic source:
- ECOTOXICOLOGY AND ENVIRONMENTAL SAFETY 17, 339-371 (1989)
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Review of literature data
- GLP compliance:
- no
Test material
- Reference substance name:
- Boric acid
- EC Number:
- 233-139-2
- EC Name:
- Boric acid
- Cas Number:
- 10043-35-3
- Molecular formula:
- H3BO3
- IUPAC Name:
- Boric acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- White odourless crystalline powder
Melting point: 168 - 171 °C
Water solubility: 49.5 g/l
pH-value: 3.8 - 4.8
Decomposition temperature: ca. 100 - 130 °C
Formation of metaboric acid by loss of water. At 160 deg C a glassy melt of boron trioxide is formed by further loss of water.
LD50 oral rat: 2660 mg/kg
Constituent 1
Sampling and analysis
- Analytical monitoring:
- not specified
Test solutions
- Vehicle:
- not specified
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna Straus
Study design
- Test type:
- static
- Water media type:
- freshwater
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 150 resp. 166 mg/L
- Test temperature:
- 20 resp. 19.2 °C
- pH:
- 6.7 - 8.1 resp. 7.1 - 8.7
- Details on test conditions:
- TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Lake Huron water resp. Carbon-filtered well water - Reference substance (positive control):
- not specified
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 133 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 1007.7 mg/L BHO2.K
- Remarks:
- Lake Huron water, 20°C, pH 6.7 - 8.1, Hardness 150 mg/l
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 226 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- not specified
- Remarks on result:
- other: corresponding to 1712.3 mg/L BHO2.K
- Remarks:
- Carbon-filtered well water, 19.2°C, pH 7.1 - 8.7, hardness 166 mg/L
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The present information was based on a literature review of various suitable read-across substances all belonging to the group of borates, the relevant information on short term toxicity in daphnia magna was taken from boric acid. The lowest available LC50 value was 133 mg/L, which corresponds to 1007 mg/l BHO2.K. So the available data shows that neither boron nor potassium metaborate needs to be classified as aquatic toxic acc. Regulation 1272/2008, as all LC50 values were above the limit value for classification of 100 mg/l.
- Executive summary:
A literature review of showed that boron / potassium metaborate gave consistently LC50 values > 100 mg/l.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.