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EC number: 234-541-0 | CAS number: 12008-41-2
- 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
Skin sensitisation
Disodium octaborate tetrahydrate was tested in a Buehler method skin sensitisation test (Wnorowski, 1994) according to OECD 406 applied at a concentration of 95 % (powder moistened with water) during both the induction and challenge phase of the test. No signs of skin sensitisation were observed. No evidence of skin sensitisation in humans exposed occupationally to borates has been reported (Bruze et al., 1995).
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- OECD Guideline 406 "Skin Sensitisation" method (Buehler test) was performed before the LLNA was set as preferred test method.
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- albino
- Sex:
- not specified
- 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: 282 - 411 grams - Route:
- other: Topical
- Vehicle:
- water
- Remarks:
- moistened
- Concentration / amount:
- 0.4 g of 95 % w/w DOT
- No.:
- #1
- Route:
- other: Topical
- Vehicle:
- water
- Remarks:
- moistened
- Concentration / amount:
- 0.4 g of 95 % w/w DOT
- No. of animals per dose:
- 20
- Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: Three
- Test groups: Test substance moistened with distilled water to enhance skin contact.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Test groups: Test substance moistened with distilled water to enhance skin contact.
- Concentrations: 95 % w/w/boric acid
- Evaluation (hr after challenge): 24 h and 48 h after challenge
OTHER:
- Removal of the test substance: After 6 h the test substance was wiped off with water. - Challenge controls:
- No data
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene
- Positive control results:
- At 24 h 10 /20 animals in the positive control group had a score greater than 0.5 with a severity score of 0.80. At 48 h this number was reduced to 7/20 with a severity score of 0.53.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 g of 95 % DOT (moistened with distilled water)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 g of 95 % DOT (moistened with distilled water)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.03 % DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.03 % DNCB
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.4 g of 95 % DOT (moistened with distilled water)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.4 g of 95 % DOT (moistened with distilled water)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.03 % DNCB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.03 % DNCB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Disodium octaborate tetrahydrate was determined to be not sensitising in guinea pigs according to OECD Guideline 406.
- Executive summary:
The test item disodium octaborate tetrahydrate has been evaluated for its sensitising potenial to skin in an OECD Guideline 406 "Skin Sensitisation" Buehler test according to GLP in guinea pigs. The test item has been applied at a concentration of 95 % (powder moistened with water) during both the induction and challenge phase of the test to 20 guinea pigs. No signs of skin sensitisation were observed.
Reference
Very faint erythema (0.5) was noted at three test sites 24 hours after first induction dose.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are no data to suggest that disodium octaborate tetrahydrate is a respiratory sensitiser.
Justification for classification or non-classification
Disodium octaborate tetrahydrate is not a skin or respiratory sensitiser. In accordance with the criteria of Regulation (EC) No 1272/2008 (CLP Regulation) disodium octaborate tetrahydrate does not need to be classified and labelled as a skin or respiratory sensitiser.
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