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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- publication / peer-reviewed report
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- peer-reviewed
- 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:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- publication / peer-reviewed report
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- peer-reviewed
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
see target record - Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across source
- Remarks:
- target record
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Review of literature data
- GLP compliance:
- no
- Species:
- other: mostly rabbits, also guinea pigs, rats, dogs
- Strain:
- not specified
- Type of coverage:
- other: various
- Preparation of test site:
- other: various
- Vehicle:
- other: various
- Details on study design:
- a) The procedure for testing and evaluating the primary skin irritation of borax, Na2B4O7.10H2O, (10 ml, 5% in water (w/v)) or boric acid (5ml, 10% in water (w/v)) on rabbit skin was identical to that described in the U.S. Regulations (21 CFR 191.11), except that the rabbits were not immobilised, and the 1-inch square cellulose pads were used instead of surgical gauze. The substance was applied to 6 rabbits with intact and 6 with abraded skin. A similar test procedure in the guinea pig included application of the aqueous solutions of the materials on cellulose pads held in contact with the skin under an appropriate sleeve. Six guinea pigs with clipped, depilated, intact abdomens and 6 with clipped, depilated, abraded backs were used with each material.
b) The primary dermal irritation of disodium tetraborate pentahydrate, Na2O4O7 * 5H2O, was determined by applying 0.5 g moistened with saline on two clipped sites on the backs of 6 rabbits. The contact time was 4 hours under an occlusive dressing, with observation for up to 76 hours.
c) The detailed toxicological properties of boric oxide (B2O3) in rats, rabbits and dogs have been published. boric oxide dust (1g/25cm2) was topically applied to the clipped wetted backs of four rabbits.
d) Sodium perborate tetrahydrate was tested for skin irritation on six male rabbits. An area on the right flank of each animal was clipped and about 500 mg perborate, moistened to a paste with water, was applied to the test site (25x25 mm) under an occlusive dressing for 4 hours. The Draize scale was used to assess the degree of erythema and oedema at the site 1 hour and 1, 2 and 3 days after the removal of the dressing.
e) Sodium perborate tetrahydrate was applied as a paste in oil, for a 4 hour exposure.
f) A study investigating the irritant effects of repeated exposures of sodium perborate tetrahydrate to rat skin was performed over a course of 12 consecutive daily applications. - Time point:
- other: 24&72h
- Remarks on result:
- other: Mild irritant after 24 and 72 h in primary irritation test
- Remarks:
- H3BO3, rabbit, 5ml, 10% in water (w/v), intact and abraded skin
- Time point:
- other: 24&72h
- Remarks on result:
- other: Moderate irritant after 24 and 72 h in primary irritation test
- Remarks:
- H3BO3, guinea pig, 5ml, 10% in water (w/v), intact and abraded skin
- Time point:
- other: 24&72h
- Remarks on result:
- other: Mild irritant after 24 and 72 h in primary irritation test
- Remarks:
- Na2B4O7.10H2O, rabbit, 10ml, 5% in water (w/v), intact and abraded skin
- Time point:
- other: 24&72h
- Remarks on result:
- other: Mild irritant after 24 and 72 h in primary irritation test
- Remarks:
- Na2B4O7.10H2O, guinea pig, 10ml, 5% in water (w/v), intact and abraded skin
- Remarks on result:
- no indication of irritation
- Remarks:
- Na2B4O7.5H2O, rabbit, 0.5 g, clipped back, 4h, Non-irritant
- Remarks on result:
- no indication of irritation
- Remarks:
- NaBO3.4H2O, rabbit, 500 mg, paste with 0.2 ml water, on intact skin, 4h, Classified as non-irritant
- Remarks on result:
- no indication of irritation
- Remarks:
- NaBO3.4H2O, guinea pig, in vegetable oil ointment, 4h, Non-irritant
- Remarks on result:
- other: Moderately to severely irritant, but 1% solution non-irritating after 12d
- Remarks:
- NaBO3.4H2O, rat, solid applied to skin, 12 daily
- Remarks on result:
- other: Slightly irritating
- Remarks:
- NaBO3.H2O, rabbit, 0.5 g on skin, 4h
- Remarks on result:
- no indication of irritation
- Remarks:
- NaBO3.H2O, rabbit, 500 mg, paste with 0.2 ml water, on intact skin, 4h, Non-irritant
- Remarks on result:
- other: Produced erythema, that persisted for 2-3 d
- Remarks:
- B2O3, rabbit, 1 g/25cm2 dust applied to clipped wetted back
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The present information was based on a literature review (peer-reviewed) of borate studies, which gave inconsistent results ranging from not irritating to irritating. Edema and erythema scores as indicated in Regulation 1272/2008, which are required for classification, are not given. Further, due to inconsistent results, no conclusion based on expert judgement can be drawn.
- Executive summary:
A literature review of borate studies showed that these borates induced none to irritating responses, no conclusion on classification can be drawn.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Remarks:
- publication / peer-reviewed report
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- peer-reviewed
- 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
- Type of study:
- other: "skin sensitization test"
- Justification for non-LLNA method:
- The present review was published in 1995 and takes into account all information available at that time. The LLNA method was not adopted as guideline at that time yet.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5ml of the solid
- Adequacy of induction:
- not specified
- Vehicle:
- water
- Concentration / amount:
- 5% dilution in distilled water
- Day(s)/duration:
- after 14 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5
- Details on study design:
- A skin sensitization test on sodium perborate monohydrate was carried out on 5 male and 5 female Hartley albino guinea pigs. Another similar group served as controls. Twenty four hours prior to each induction, an area of 5 x 5 cm on the left flank of each animal was clipped free of hair, 0.5 ml of the solid was applied to the depilated area and covered with an occlusive dressing. The challenge (5% dilution in distilled water) was applied to the depilated right flank 14 days after the induction.
- Positive control substance(s):
- not specified
- Key result
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Reason / purpose for cross-reference:
- read-across source
- Remarks:
- target record
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- publication / peer-reviewed report
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- peer-reviewed, read-across
- 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
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- various, see free-text field below
- Duration of treatment / exposure:
- various, see free-text field below
- Observation period (in vivo):
- various, see free-text field below
- Duration of post- treatment incubation (in vitro):
- various, see free-text field below
- Number of animals or in vitro replicates:
- various, see free-text field below
- Details on study design:
- a) Six young rabbits had 100 mg of boric acid applied to one eye of each rabbit. The eyes were rinsed after 24 hours and irritation scores in individual animals ranged from 0 to 18.
b) Six young rabbits had 77 mg of borax, Na2B4O7.10H2O, applied to one eye of each rabbit. The eyes were rinsed after 24 hours and irritation scores in individual animals ranged from 0 to 39.
c) Six young rabbits had 100 mg of disodium tetraborate pentahydrate, Na2B4O7.5H2O, applied to one eye of each rabbit. The eyes were not rinsed, and the ocular reaction was recorded after 1, 24, and 72 hours and up to 10 days after treatment.
d) About 50 mg of boric oxide was placed in the left eye of four rabbits.
e) Sodium perborate tetrahydrate was tested for eye irritation on two female rabbits and the Draize scale was used for assessment of irritation. The test substance (approximately 100 mg) was applied to the conjunctival sac of the left eye of each rabbit, the other eye was untreated. The eyes were examined after 1 to 2 hours, and up to 3 or 21 days after application for each of the animals, respectively.
f) 50 mg of sodium perborate tetrahydrate was introduced into the rabbit eye.
g) The irritation of a small volume of sodium perborate tetrahydrate was assessed in three rabbits. The methods used were similar to those described above except that the amount of test material used was less, in this case a volume of 0.01 ml was used (approximating to 6 mg).
h) A 1% solution of sodium perborate tetrahydrate was instilled to the rabbit eye.
i) A test in rabbits investigated the effect of an eye washing procedure on the irritant effect of sodium perborate tetrahydrate. After instilling 100 mg of the test material into the left eye, groups of 3 rabbits received either no further treatment or the eye was washed 4 or 30 seconds later. - Reversibility:
- fully reversible within: 7 days
- Remarks:
- or less
- Remarks on result:
- other: irritating
- Remarks:
- 100 mg H3BO3 in one eye
- Reversibility:
- fully reversible within: 8-21 days
- Remarks on result:
- other: corneal irritation
- Remarks:
- 77 mg Borax in one eye
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: severe irritation
- Remarks:
- 100 mg Na2B4O7 * 5H2O in one eye
- Remarks on result:
- other: Severe irritant to the rabbit eye
- Remarks:
- Observed up to 21d; 100 mg NaBO3 * 4H2O in one eye.
- Remarks on result:
- other: Serious damage to unwashed left eye, but slight damage when rinsed after 4 or 30 seconds
- Remarks:
- 100 mg NaBO3 * 4H2O in one eye
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Acute conjunctivitis, corneal irritation at 48 hours
- Remarks:
- 50 mg NaBO3 * 4H2O in one eye
- Remarks on result:
- other: moderate irritant
- Remarks:
- observed up to 21 d; 6 mg (0.01ml) NaBO3 * 4H2O in one eye
- Remarks on result:
- other: non-irritant
- Remarks:
- 1% NaBO3 * 4H2O solution in one eye
- Remarks on result:
- other: severe irritant
- Remarks:
- Observed up to 21 days; 50 mg NaBO3 * H2O in one eye
- Remarks on result:
- other: corrosive to unwashed eye
- Remarks:
- Observed up to 21 days; 0.1 mg NaBO3 * H2O in one eye
- Remarks on result:
- other: Immediate conjunctivitis, caused by exothermic hydrolysis to boric acid
- Remarks:
- 50 mg B2O3 in one eye
- Irritation parameter:
- cornea opacity score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The present information was based on a literature review (peer-reviewed) of various borates studies, which gave inconsistent results ranging from not irritating to irritating. The scores as indicated in Regulation 1272/2008, which are required for classification, are not given. Further, due to inconsistent results, no conclusion based on expert judgement can be drawn.
- Executive summary:
A literature review of borates showed that these borates induced none to irritating responses, no conclusion on classification can be drawn.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Technical Report No 63, Reproductive and General Toxicology of some Inorganic Borates and Risk Assessment for Human Beings
- Author:
- ECETOC
- Year:
- 1 995
- Bibliographic source:
- ISSN-0773-8072-63
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
- Reference substance name:
- Diboron trioxide
- EC Number:
- 215-125-8
- EC Name:
- Diboron trioxide
- Cas Number:
- 1303-86-2
- Molecular formula:
- B2O3
- IUPAC Name:
- oxo(oxoboranyloxy)borane
- Reference substance name:
- 1303-96-4
- EC Number:
- 603-411-9
- Cas Number:
- 1303-96-4
- IUPAC Name:
- 1303-96-4
- Reference substance name:
- Reference substance 002
- EC Number:
- 601-808-1
- Cas Number:
- 12179-04-3
- Molecular formula:
- B4-O7.2Na.5H2-O
- Reference substance name:
- Disodium tetraborate, anhydrous
- EC Number:
- 215-540-4
- EC Name:
- Disodium tetraborate, anhydrous
- Cas Number:
- 1330-43-4
- Molecular formula:
- B4Na2O7
- IUPAC Name:
- Disodium tetraborate
- Reference substance name:
- Reference substance 001
- EC Number:
- 602-894-3
- Cas Number:
- 12280-03-4
- Reference substance name:
- Sodium metaborate dihydrate
- Cas Number:
- 16800-11-6
- IUPAC Name:
- Sodium metaborate dihydrate
- Reference substance name:
- Sodium metaborate tetrahydrate
- EC Number:
- 600-663-1
- Cas Number:
- 10555-76-7
- IUPAC Name:
- Sodium metaborate tetrahydrate
- Reference substance name:
- Sodium perborate
- EC Number:
- 239-172-9
- EC Name:
- Sodium perborate
- Cas Number:
- 10486-00-7
- Molecular formula:
- BH3O4.Na
- Reference substance name:
- azane;2-hydroxy-4-[(4-hydroxy-1,3,2,4-dioxadiboretan-2-yl)oxy]-1,3,2,4-dioxadiboretane;tetrahydrate
- Cas Number:
- 10135-84-9; 12228-87-4
- Molecular formula:
- B4H16N2O11
- IUPAC Name:
- azane;2-hydroxy-4-[(4-hydroxy-1,3,2,4-dioxadiboretan-2-yl)oxy]-1,3,2,4-dioxadiboretane;tetrahydrate
- Reference substance name:
- 12046-04-7
- EC Number:
- 601-709-3
- Cas Number:
- 12046-04-7
- IUPAC Name:
- 12046-04-7
- Reference substance name:
- Dipotassium tetraborate
- EC Number:
- 215-575-5
- EC Name:
- Dipotassium tetraborate
- Cas Number:
- 1332-77-0
- Molecular formula:
- B4K2O7
- IUPAC Name:
- dipotassium tetraborate
- Reference substance name:
- Hexaboron dizinc undecaoxide
- EC Number:
- 235-804-2
- EC Name:
- Hexaboron dizinc undecaoxide
- Cas Number:
- 138265-88-0
- Molecular formula:
- 2ZnO·3B2O3·3H2O [ZnB3O4(OH)3]
- IUPAC Name:
- dodecaboron tetrazinc docosaoxide heptahydrate
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Constituent 13
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- various, see free-text field below
- Duration of treatment / exposure:
- various, see free-text field below
- Observation period (in vivo):
- various, see free-text field below
- Duration of post- treatment incubation (in vitro):
- various, see free-text field below
- Number of animals or in vitro replicates:
- various, see free-text field below
- Details on study design:
- a) Six young rabbits had 100 mg of boric acid applied to one eye of each rabbit. The eyes were rinsed after 24 hours and irritation scores in individual animals ranged from 0 to 18.
b) Six young rabbits had 77 mg of borax, Na2B4O7.10H2O, applied to one eye of each rabbit. The eyes were rinsed after 24 hours and irritation scores in individual animals ranged from 0 to 39.
c) Six young rabbits had 100 mg of disodium tetraborate pentahydrate, Na2B4O7.5H2O, applied to one eye of each rabbit. The eyes were not rinsed, and the ocular reaction was recorded after 1, 24, and 72 hours and up to 10 days after treatment.
d) About 50 mg of boric oxide was placed in the left eye of four rabbits.
e) Sodium perborate tetrahydrate was tested for eye irritation on two female rabbits and the Draize scale was used for assessment of irritation. The test substance (approximately 100 mg) was applied to the conjunctival sac of the left eye of each rabbit, the other eye was untreated. The eyes were examined after 1 to 2 hours, and up to 3 or 21 days after application for each of the animals, respectively.
f) 50 mg of sodium perborate tetrahydrate was introduced into the rabbit eye.
g) The irritation of a small volume of sodium perborate tetrahydrate was assessed in three rabbits. The methods used were similar to those described above except that the amount of test material used was less, in this case a volume of 0.01 ml was used (approximating to 6 mg).
h) A 1% solution of sodium perborate tetrahydrate was instilled to the rabbit eye.
i) A test in rabbits investigated the effect of an eye washing procedure on the irritant effect of sodium perborate tetrahydrate. After instilling 100 mg of the test material into the left eye, groups of 3 rabbits received either no further treatment or the eye was washed 4 or 30 seconds later.
Results and discussion
In vivo
Resultsopen allclose all
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- or less
- Remarks on result:
- other: irritating
- Remarks:
- 100 mg H3BO3 in one eye
- Reversibility:
- fully reversible within: 8-21 days
- Remarks on result:
- other: corneal irritation
- Remarks:
- 77 mg Borax in one eye
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: severe irritation
- Remarks:
- 100 mg Na2B4O7 * 5H2O in one eye
- Remarks on result:
- other: Severe irritant to the rabbit eye
- Remarks:
- Observed up to 21d; 100 mg NaBO3 * 4H2O in one eye.
- Remarks on result:
- other: Serious damage to unwashed left eye, but slight damage when rinsed after 4 or 30 seconds
- Remarks:
- 100 mg NaBO3 * 4H2O in one eye
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Acute conjunctivitis, corneal irritation at 48 hours
- Remarks:
- 50 mg NaBO3 * 4H2O in one eye
- Remarks on result:
- other: moderate irritant
- Remarks:
- observed up to 21 d; 6 mg (0.01ml) NaBO3 * 4H2O in one eye
- Remarks on result:
- other: non-irritant
- Remarks:
- 1% NaBO3 * 4H2O solution in one eye
- Remarks on result:
- other: severe irritant
- Remarks:
- Observed up to 21 days; 50 mg NaBO3 * H2O in one eye
- Remarks on result:
- other: corrosive to unwashed eye
- Remarks:
- Observed up to 21 days; 0.1 mg NaBO3 * H2O in one eye
- Remarks on result:
- other: Immediate conjunctivitis, caused by exothermic hydrolysis to boric acid
- Remarks:
- 50 mg B2O3 in one eye
- Irritation parameter:
- cornea opacity score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not available
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The present information was based on a literature review (peer-reviewed) of various borates studies, which gave inconsistent results ranging from not irritating to irritating. The scores as indicated in Regulation 1272/2008, which are required for classification, are not given. Further, due to inconsistent results, no conclusion based on expert judgement can be drawn.
- Executive summary:
A literature review of borates showed that these borates induced none to irritating responses, no conclusion on classification can be drawn.
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