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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 215-575-5 | CAS number: 1332-77-0
- 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
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- 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:
- OECD Guideline 406 "Skin Sensitisation" method (Buehler test ) was performed before the LLNA was set as preferred test method.
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 601-808-1
- Cas Number:
- 12179-04-3
- Molecular formula:
- Na2B4O7.5H2O
- Details on test material:
- - Name of test material: Sodium tetraborate pentahydrate
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: 4ho2-2471
- Stability under test conditions: Stable
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.4 g 95 % w/w substance.
Challenge
- 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- 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:
- positive indication of skin sensitisation
- 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:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- 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.
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.
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