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EC number: 231-151-2 | CAS number: 7440-42-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-02-27 to 2001-03-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1992-07-17
- Deviations:
- yes
- Remarks:
- deviation from the guideline occurred, with no effect on the results of the study: individual body weights of the animals were not given
- GLP compliance:
- yes
Test material
- Reference substance name:
- Boron
- EC Number:
- 231-151-2
- EC Name:
- Boron
- Cas Number:
- 7440-42-8
- Molecular formula:
- B
- IUPAC Name:
- borane
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Boron amorphous
- Physical state: powder
- Storage condition of test material: room temperature
- Average particle size: 0.9 µm
- Specific surface area: 11.1 m^2/g
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England
- Age at study initiation: at least 12 weeks of age
- Weight at study initiation: 2.6 to 2.8 kg
- Housing: animals were housed individually in stainless steel cages with perforated floors.
- Diet (ad libitum): a standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet); the animals were fed hay on arrival and subsequently three times a week.
- Water (ad libitum): drinking water
- Acclimation period: five days prior to start of study
During the acclimatisation and study period the animals were given small (approximately 5 cm x 2 cm x 2 cm) soft white untreated wood blocks for environmental enrichment.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2°C
- Relative humidity: 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 0.5 g of the test substance moistened with distilled water.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- approximately 60 minutes after removal of the dressings and approximately 24, 48 and 72 hours after exposure
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumber region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
The test substance was applied under a 2-ply 25 mm x 25 mm porous gauze pad, which had been moistened with distilled water, to one intact skin site on each animal.
- Type of wrap: each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
REMOVAL OF TEST SUBSTANCE
- Washing: the dressing and gauze pad were removed and the treatment site was washed with warm water (37°C) to remove any residual test substance. The treated area was blotted dry with absorbant paper.
- Time after start of exposure: at the end of the exposure period
SCORING SYSTEM: according to the Draize scoring system
Any other reaction not covered by this scoring system was described.
OBSERVATIONS:
- Clinical sings: all animals were observed daily for signs of ill health or toxicity.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Brown residual test substance staining (assessment of erythema not impaired) was observed at the approximately 60 minutes and 24 hour observations.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Brown residual test substance staining (assessment of erythema not impaired) was observed at the approximately 60 minutes and 24 hour observations.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Brown residual test substance staining (assessment of erythema not impaired) was observed at the approximately 60 minutes and 24 hour observations.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No dermal irritation was observed following a single semi-occlusive application of boron amorphous to intact rabbit skin for four hours. Brown residual test substance staining (which did not impair assessment of erythema) was noted for all animals during the study.
- Other effects:
- - Clinical signs: there were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- A single semi-occlusive application of boron amorphous to intact rabbit skin for four hours elicited no dermal irritation.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as skin irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
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