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EC number: 946-013-3 | CAS number: -
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study. This study is conducted on an analogue substance. Read-across is justified on the following basis: 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. At about pH 10 the metaborate anion (B(OH)4-) becomes the main species in solution (WHO, 1998). This leads to the conclusion that the main species in the plasma of mammals and in the environment is un-dissociated boric acid. Since other borates dissociate to form boric acid in aqueous solutions, they too can be considered to exist as un-dissociated boric acid under the same conditions. For comparative purposes, exposures to borates are often expressed in terms of boron (B) equivalents based on the fraction of boron in the source substance on a molecular weight basis. Some studies express dose in terms of B, whereas other studies express the dose in units of boric acid. Since the systemic effects and some of the local effects can be traced back to boric acid, results from one substance can be transferred to also evaluate the another substance on the basis of boron equivalents. Therefore data obtained from studies with these borates can be read across in the human health assessment for each individual substance. Conversion factors are given in the table below. Conversion factor for equivalent dose of B Boric acid H3BO3 0.175 Boric Oxide B2O3 0.311 Disodium tetraborate anhydrous Na2B4O7 0.215 Disodium tetraborate pentahydrate Na2B4O7•5H2O 0.148 Disodium tetraborate decahydrate Na2B4O7•10H2O 0.113 Disodium octaborate tetrahydrate Na2B8O13•4H2O 0.210 Sodium metaborate (anhydrous) NaBO2 0.1643 Sodium metaborate (dihydrate) NaBO2•2H2O 0.1062 Sodium metaborate (tetrahydrate) NaBO2•4H2O 0.0784 Sodium pentaborate (anhydrous) NaB5O8 0.2636 Sodium pentaborate (pentahydrate) NaB5O8∙5H2O 0.1832 References: WHO. Guidelines for drinking-water quality, Addendum to Volume 1, 1998.
- Qualifier:
- according to guideline
- Guideline:
- other: Galloway et.al., 1985; NTP protocol
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- sister chromatid exchange assay in mammalian cells
- Target gene:
- No data
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat (Sprague-Dawley) liver S9 fraction
- Test concentrations with justification for top dose:
- With S-9; 200,300,400,and 500 µg/mL
Without S-9; 250, 500, 1600, 2000 µg/mL - Vehicle / solvent:
- Water
- Positive controls:
- yes
- Positive control substance:
- other: Mitomycin
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- Induction of SCEs in Chinese Hamster Ovary Cells
- Evaluation criteria:
- Induction of SCEs in Chinese Hamster Ovary Cells
- Statistics:
- No data
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Additional information on results:
- No data
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
This method generally complies with OECD 482 (DNA damage and repair, unscheduled DNA synthesis in mammalian cells in vitro). Negative result obtained for induction of sister chromatid exchange.
Read-across is justified on the basis detailed in the rationale for reliability above. This study is therefore considered to be of sufficient adequacy and reliability to be used as a supporting study and no further testing is justified. - Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study. This study is conducted on an analogue substance. Read-across is justified on the following basis: 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. At about pH 10 the metaborate anion (B(OH)4-) becomes the main species in solution (WHO, 1998). This leads to the conclusion that the main species in the plasma of mammals and in the environment is un-dissociated boric acid. Since other borates dissociate to form boric acid in aqueous solutions, they too can be considered to exist as un-dissociated boric acid under the same conditions. For comparative purposes, exposures to borates are often expressed in terms of boron (B) equivalents based on the fraction of boron in the source substance on a molecular weight basis. Some studies express dose in terms of B, whereas other studies express the dose in units of boric acid. Since the systemic effects and some of the local effects can be traced back to boric acid, results from one substance can be transferred to also evaluate the another substance on the basis of boron equivalents. Therefore data obtained from studies with these borates can be read across in the human health assessment for each individual substance. Conversion factors are given in the table below. Conversion factor for equivalent dose of B Boric acid H3BO3 0.175 Boric Oxide B2O3 0.311 Disodium tetraborate anhydrous Na2B4O7 0.215 Disodium tetraborate pentahydrate Na2B4O7•5H2O 0.148 Disodium tetraborate decahydrate Na2B4O7•10H2O 0.113 Disodium octaborate tetrahydrate Na2B8O13•4H2O 0.210 Sodium metaborate (anhydrous) NaBO2 0.1643 Sodium metaborate (dihydrate) NaBO2•2H2O 0.1062 Sodium metaborate (tetrahydrate) NaBO2•4H2O 0.0784 Sodium pentaborate (anhydrous) NaB5O8 0.2636 Sodium pentaborate (pentahydrate) NaB5O8∙5H2O 0.1832 References: WHO. Guidelines for drinking-water quality, Addendum to Volume 1, 1998.
- Qualifier:
- according to guideline
- Guideline:
- other: 40 CFR Part 158 US-EPA-FIFRA, Section 156.340
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine kinase, TK locus of the L5178Y mouse lymphoma cell line
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- No data
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix or other (Aroclor 1254 induced rat (Fischer 344) liver S9 fraction used at 1 %).
- Test concentrations with justification for top dose:
- 0, 1.2, 1.7, 2.45, 3.5 and 5.0 mg/mL boric acid.
- Vehicle / solvent:
- No data
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Positive controls:
- yes
- Positive control substance:
- other: Hycanthone methylsulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: ROP plus 5 % heat treated horse serum
NUMBER OF CELLS EVALUATED: Approximately 600/dose - Evaluation criteria:
- Mutations at the TK locus
- Statistics:
- No data
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Concentration related cytoxicity (60 % reduction over controls at 5 mg/mL)
- Additional information on results:
- Concentration related cytotoxicity (60 % reduction over controls at 5 mg/mL).
Increase in ouabain resistance seen (not significant). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance was not mutagenic but cytotoxicity observed at 5 mg/mL (maximum dose level).
Read-across is justified on the basis detailed in the rationale for reliability above. This study is therefore considered to be of sufficient adequacy and reliability to be used as a supporting study and no further testing is justified. - 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:
- 14-05-91 to 12-08-91
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevent results. This study is conducted on an analogue substance. Read-across is justified on the following basis: 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. At about pH 10 the metaborate anion (B(OH)4-) becomes the main species in solution (WHO, 1998). This leads to the conclusion that the main species in the plasma of mammals and in the environment is un-dissociated boric acid. Since other borates dissociate to form boric acid in aqueous solutions, they too can be considered to exist as un-dissociated boric acid under the same conditions. For comparative purposes, exposures to borates are often expressed in terms of boron (B) equivalents based on the fraction of boron in the source substance on a molecular weight basis. Some studies express dose in terms of B, whereas other studies express the dose in units of boric acid. Since the systemic effects and some of the local effects can be traced back to boric acid, results from one substance can be transferred to also evaluate the another substance on the basis of boron equivalents. Therefore data obtained from studies with these borates can be read across in the human health assessment for each individual substance. Conversion factors are given in the table below. Conversion factor for equivalent dose of B Boric acid H3BO3 0.175 Boric Oxide B2O3 0.311 Disodium tetraborate anhydrous Na2B4O7 0.215 Disodium tetraborate pentahydrate Na2B4O7•5H2O 0.148 Disodium tetraborate decahydrate Na2B4O7•10H2O 0.113 Disodium octaborate tetrahydrate Na2B8O13•4H2O 0.210 Sodium metaborate (anhydrous) NaBO2 0.1643 Sodium metaborate (dihydrate) NaBO2•2H2O 0.1062 Sodium metaborate (tetrahydrate) NaBO2•4H2O 0.0784 Sodium pentaborate (anhydrous) NaB5O8 0.2636 Sodium pentaborate (pentahydrate) NaB5O8∙5H2O 0.1832 References: WHO. Guidelines for drinking-water quality, Addendum to Volume 1, 1998.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- There is a failure to justify the maximum concentration of 2500 ug/plate
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA 40 CFR Part 158; FIFRA, Section 158.340
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9 at 4 % and 10 %
- Test concentrations with justification for top dose:
- 10; 50; 100; 1000; 2500 μg/plate
- Vehicle / solvent:
- Water
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Positive controls:
- yes
- Positive control substance:
- other: 2-Anthramine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In water
DURATION
- Preincubation period: None - Evaluation criteria:
- No data
- Statistics:
- No data
- 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 specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Additional information on results:
- No data
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The study was performed according to Guideline 84-2 and is comparable to OECD 471. The test substance was not mutagenic in any of the strains tested with or without metabolic activation.
Read-across is justified on the basis detailed in the rationale for reliability above. This study is therefore considered to be of sufficient adequacy and reliability to be used as a supporting study and no further testing is justified.
Referenceopen allclose all
Gene mutation assay results:
Concentration mg/mL |
Number of mutant cells per 106cells ± SD |
Comments give information on cytotoxicity or other |
|||
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
||
-S9 |
-S9 |
+S9 |
+S9 |
||
0 |
54 ± 10 |
42 ± 1 |
29 ± 10 |
36 ± 7 |
|
1.2 |
46 ± 28 |
38 ± 15 |
34 ± 0 |
36 ± 7 |
|
1.7 |
39 ± 17 |
31 ± 9 |
41 ± 7 |
49 ± 4 |
|
2.45 |
27 ± 3 |
32 ± 9 |
40 ± 16 |
36 ± 6 |
Minor cytotoxicity seen |
3.5 |
31 ± 18 |
46 ± 1 |
41 ± 13 |
41 ± 6 |
Cytotoxicity seen |
5 |
50 ± 22 |
41 ± 5 |
53 ± 2 |
47 ± 3 |
Cytotoxicity seen. Increase in + S9 in first study not reproduced. |
Additional information
Assessment entity approach
"Brazing fluxes" are mixtures of boron-containing constituents (potassium(fluoro)borates), which undergo chemical exchanges (anion exchange) and condensation reactions (e.g. formation of oligoborates, polyborates) upon mixing and further manufacturing. This results in a complex mixture of potassium borates, which cannot be fully chemically characterised for substance identity. Thus, according to the definition under REACH, such brazing fluxes must be described as a UVCB substance.
Data specifically on the UVCB substance to be registered are not available. An assessment entity approach is followed based on the transformation products of this UVCB uppon dissolution in aqueous media. The substance is highly soluble and forms complex boron, potassium and fluoride constituents. The quantitatively predominant transformation product of this UVCB is represented by boric acid, which is assumed to be the determinant of human health effects because of its classification and its toxicity. For this reason, the assessment is based on information for “borates” (including potassium borate, boric acid and other borate substances).
Based on the information provided below, it may safely be assumed that under physiological conditions the chemical speciation of most of the unknown potassium boron compounds corresponds to boric acid. Thus, from a chemical point of view, there is no reason to assume that brazing fluxes would behave differently than boric acid and/or borates under physiological conditions.
The basis of this assessment entity approach is further justified by the following reasoning:
In aqueous solutions at physiological and acidic pH, low concentrations of simple inorganic borates such as boric acid B(OH)3, potassium pentaborate (K2B10O16*8H2O), potassium tetraborate (K2B4O7*4H2O), disodium tetraborate decahydrate (Na2B4O7.10H2O; borax), disodium tetraborate pentahydrate (Na2B4O7*5H2O; borax pentahydrate), boric oxide (B2O3) and disodium octaborate tetrahydrate (Na2B8O13*4H2O) will predominantly exist as undissociated boric acid. Above pH 9 the metaborate anion (B(OH)4-) becomes the main species in solution (WHO, 1998). This leads to the conclusion that the main species in the plasma of mammals and in the environment is undissociated boric acid. Since other borates dissociate to form boric acid in aqueous solutions, they too can be considered to exist as undissociated boric acid under the same conditions.
For comparative purposes, exposures to borates are often expressed in terms of boron (B) equivalents based on the fraction of boron in the source substance on a molecular weight basis. Some studies express dose in terms of B, whereas other studies express the dose in units of boric acid. Since the systemic effects and some of the local effects can be traced back to boric acid, results from one substance can be transferred to also evaluate the another substance on the basis of boron equivalents. Therefore data obtained from studies with these borates can be read across in the human health assessment for each individual substance. Conversion factors are given in the table below.
Substance |
Formula |
Conversion factor for equivalent dose of B (multiply by) |
|||
Boric acid |
H3BO3 |
0.1748 |
|||
Boric Oxide |
B2O3 |
0.311 |
|||
Disodium tetraborate anhydrous |
Na2B4O7 |
0.2149 |
|||
Disodium tetraborate pentahydrate |
Na2B4O7•5H2O |
0.1484 |
|||
Disodium tetraborate decahydrate |
Na2B4O7•10H2O |
0.1134 |
|||
Disodium octaborate tetrahydrate |
Na2B8O13·4H2O |
0.2096 |
|||
Sodium metaborate (anhydrous) |
NaBO2 |
0.1643 |
|||
Sodium metaborate (dihydrate) |
NaBO2·2H2O |
0.1062 |
|||
Sodium metaborate (tetrahydrate) |
NaBO2·4H2O |
0.0784 |
|||
Sodium pentaborate (anhydrous) |
NaB5O8 |
0.2636 |
|||
Sodium pentaborate (pentahydrate) |
NaB5O8∙5H2O |
0.1832 |
|||
Dipotassium tetraborate (anhydrous) |
|
K2B4O7 |
|
0.185 |
|
Dipotassium tetraborate (tetrahydrate) |
|
K2B4O7.4H2O |
|
0.1415 |
|
Potassium pentaborate (anhydrous) |
|
B5KO8 |
|
0.244 |
|
Potassium pentaborate (tetrahydrate) |
|
B5KO8.4H2O |
|
0.1843 |
|
Reference: WHO. Guidelines for drinking-water quality, Addendum to Volume 1, 1998
Conclusions on genetic toxicity of brazing flux:
In the absence of substance-specific information on genetic toxicity for the test item brazing fluxes, and because borates are considered the transformation product driving the human health effects for brazing fluxes, the results for borates are also applicable for brazing fluxes.
A number of in vitro mutagenicity studies, including bacterial mutation assays in Salmonella typhimurium and Escherichia coli, gene mutation in mammalian cells (L5178Y mouse lymphoma, V79 Chinese hamster cells, C3H/10T1/2 cells), bacterial DNA-damage assay, unscheduled DNA synthesis (hepatocytes), chromosomal aberration and sister chromatid exchange in mammalian cells (Chinese hamster ovary, CHO cells) have been carried out on boric acid and one study on disodium tetraborate decahydrate.
In conclusion, no evidence of mutagenic activity whatsoever was observed in vitro. In addition, one in vivo study on boric acid also indicated no mutagenic activity.
Short description of key
information:
No substance specific information on genetic toxicity of the test
item brazing fluxes is available. In vitro gene mutation studies in
bacteria (Stewart, 1991) in vitro gene mutation studies in mammalian
cells (Rudd, 1991) and in vitro cytogenicity studies (NTP, 1987)
concluded that boric acid is not genotoxic under the conditions of the
studies. In addition the results of an in vivo bone marrow cytogenetic
assay (chromosome aberration assay, O’Loughlin 1991) also showed boric
acid to be non genotoxic.
Because borates are considered the transformation product driving the human health effects for brazing fluxes (see 'discussion`), this result is also applicable to the brazing fluxes.
Cytotoxicity observed at 5 mg/mL in
the in vitro gene mutation studies in mammalian cells (Rudd, 1991).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Justification for classification or non-classification:
Genetic toxicity
None of the in vitro and in vivo studies for boric acid and disodium tetraborate decahydrate (all rated as reliable) showed any indications of genotoxicity whatsoever, rendering the group of borates void of genotoxicity. The classification criteria according to Regulation (EC) 1272/2008 as germ cell mutagen are also not met.
The above described results are considered to apply to the brazing fluxes substances without restriction because borates are considered the transformation product driving the human health effects for brazing fluxes (see 'discussion`).
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.