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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
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Skin sensitisation
Administrative data
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- 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 - 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:
- 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.
- 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.
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
- 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.
Test material
- Reference substance name:
- Sodium peroxometaborate
- EC Number:
- 231-556-4
- EC Name:
- Sodium peroxometaborate
- Cas Number:
- 10332-33-9
- Molecular formula:
- NaBO3*H2O
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5ml of the solid
- Adequacy of induction:
- not specified
Challenge
- 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
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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