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Diss Factsheets
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EC number: 235-111-5 | CAS number: 12069-32-8
- 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
Endpoint summary
Administrative data
Description of key information
No studies are available for the Sensitisation endpoint with boron carbide. Due to the inherent physical-chemical properties of boron carbide (practically insoluble in water, not bioavailable, no structural alerts) and long-term experience in manufacturing, handling and use, no skin sensitisation is to be expected from boron carbide and further testing for sensitisation is considered scientifically unnecessary.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
A sensitizer is an agent that is able to cause an allergic response in susceptible individuals. Following exposure via the skin by the allergen, the characteristic adverse health effects of allergic contact dermatitis or atopic dermatitis may be provoked. According to ECHA Guidance on information requirements and chemical safety assessment, the skin sensitisation potential of a chemical is related to its ability to react with skin proteins to form covalently linked conjugates and recognition of these by the immune system. In the vast majority of cases, this is dependent on electrophilic reactivity of the skin sensitizer or a derivative produced (usually by oxidation) in vivo or abiotically. Among the key steps required for a chemical to induce sensitisation via skin contact are gaining access to the viable epidermis, protein binding, metabolic activation (if required), internalization and processing by Langerhans cells (LC), transport of antigen by LC to draining lymph nodes, and presentation to and recognition by T lymphocytes. Epidermal bioavailability and chemical reactivity are key factors which may indicate the sensitising effect of a substance. Skin penetration is a prerequisite for skin sensitisation.
Boron Carbide („Black Diamond“), a covalent non-metallic carbide, is an inorganic solid with a high chemical inertness. With a hardness of 9.3 on the mohs scale, it is one of the hardest materials known, behind cubic boron nitride and diamond. It does not noticeably react with chlorine or oxygen below 1,000 °C, is completely inert against hydrogen fluoride and hot nitric acid and is practically insoluble in water (see section 4.8 of the IUCLID dossier) and organic solvents [1]. Due to its inherent properties (insoluble, no lipophilic characteristics), boron carbide does not cross biological membranes, is not bioavailable and does not have skin penetration properties. Therefore, boron carbide does not have any potential of being a skin sensitizer. The majority of chemical allergens is electrophilic and reacts with nucleophilic amino acids. Boron carbide does not contain any electrophilic structural elements or electrophilic reactive groups being able to react with amino acids or to build covalently linked conjugates. B2O3 is the only Boron containing impurity of B4C soluble in water (see section 4.8 of the IUCLID dossier). B2O3 forms boric acid when getting in contact with water. However, boric acid itself is neither a skin nor a respiratory sensitizer [2]. Furthermore, companies involved in the elaboration of the registration dossier confirmed by certificates of their company doctors that in up to 23 years of manufacturing, handling and use of B4C no cases of skin sensitisation or respiratory sensitisation occurred due to exposure of workers to B4C. For details see attached company declarations on observations of skin and eye irritation/corrosion and sensitising effects related to handling and use of boron carbide.
Conclusion: Due to the inherent physical-chemical properties of boron carbide (practically insoluble in water, not bioavailable, no structural alerts) and long-term experience in manufacturing, handling and use, no skin sensitisation is to be expected from boron carbide. Against this background and in conformity with ECHAs principle of avoiding unnecessary animal testing, it is considered unnecessary to perform a skin sensitisation study.
Literature:
[1] Hollemann A.F., Wiberg E., Lehrbuch der anorganischen Chemie, 101. Auflage, Walter de Gruyter, New York 1995.
[2] Transitional annex XV dossier on boric acid submitted by Austria. http://echa.europa.eu/chem_data/transit_measures/annex_xv_trans_reports_en.asp
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on data describing the inherent physical-chemical properties of Boron Carbide (sand-like, granulated, solid particles insoluble in water, showing no acidity) and long-term experience in manufacture, handling and use of the substance, it is not considered likely that boron carbide will cause sensitisation to the skin and respiratory tract.
Therefore, classification according to the criteria set out in Annex I of Regulation (EC) No. 1272/2008 (CLP criteria) is not warranted.
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.
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