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EC number: 946-014-9 | 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
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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: GLP guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- not reported
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson’s Mill Farms, South Brunswick, NJ.
- Age at study initiation: Young adult
- Weight at study initiation: Males: 314 -411 g; females: 256-441 g - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.4 g 95 % w/w substance.
- Route:
- other: Not specified
- Vehicle:
- water
- Concentration / amount:
- 0.4 g 95 % w/w substance.
- No. of animals per dose:
- Test group: 20 animals
Naive control: 10 animals
Positive control: 20 animals
Positive naive control: 10 animals - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Day 0, Day 7 and Day 21
- Test groups: 0.4 g 95 % w/w substance moistened with distilled water to enhance skin contact.
- Frequency of applications: Day 0, Day 7 and Day 21
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: After 6 hours test substance wiped off with water
- Concentrations: 95 % w/w substance moistened with distilled water to enhance skin contact
- Evaluation: 24h & 48 h - Challenge controls:
- No data
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 g 95 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None specified
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4 g 95 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None specified.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 g 95 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None specified
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4 g 95 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None specified.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None specified
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None specified.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None specified
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None specified.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not specified
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: Not specified. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: Not specified.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not specified
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: Not specified. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: Not specified.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- A study was performed according to OECD Guideline 406 "Skin Sensitisation" method (Buehler test ) using 95 % w/w disodium tetraborate pentahydrate moistened with distilled water to enhance skin contact. No irritation was observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- 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 skin sensitisation:
Skin sensitisation studies specifically with brazing fluxes are not available. However, data on borate substances indicate that these are not skin sensitisers: disodium tetraborate decahydrate and disodium tetraborate pentahydrate were tested in a Buehler method skin sensitisation test (Wnorowski, 1994) applied at a concentration of 95% (powder moistened with water) during both the induction and challenge phase of the test.
Migrated from Short description of key information:
No skin sensitization studies with the brazing fluxes or dipotassium tetraborates were available however the data indicate that these borates are not sensitizers. Skin sensitisation tests on disodium tetraborate decahydrate and disodium tetraborate pentahydrate were performed according to OECD Guideline 406 (Buehler method).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Migrated from Short description of key information:
There is no evidence on specific respiratory hypersensitivity in test animals following acute inhalation exposure with borates.
Justification for classification or non-classification
Skin Sensitisation:
In studies performed with the substances disodium tetraborate decahydrate and disodium tetraborate pentahydrate according to OECD Guideline 406 "Skin Sensitisation" method (Buehler test), no skin sensitisation was observed.
According to the criteria specified by Directive 67/548/EEC borates are correspondingly considered not to require classification for skin sensitisation; the same conclusion is derived also according to the criteria set forth by EC Regulation No. 1272/2008 and subsequent regulations,
Respiratory sensitisation:
There is no evidence on specific respiratory hypersensitivity in test animals following acute inhalationexposure with borates.
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.
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