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Diss Factsheets
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EC number: 228-845-2 | CAS number: 6362-79-4
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: expert opinion
- Adequacy of study:
- supporting study
- Study period:
- 22 January 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- other: toxicokinetic assessment
- Principles of method if other than guideline:
- Expert judgement in the assessment of toxicokinetic parameters based on available data.
- GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- other: none
- Strain:
- other: none
- Route of administration:
- other: oral, dermal and inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- see assessment
- Type:
- absorption
- Results:
- assumed 100% by inhalation; 50% by oral/dermal
- Conclusions:
- A toxicokinetic assessment based on the measured and known physical chemical properties of the material and on all available toxicological data was performed. It is concluded that once absorbed from the gastrointestinal tract, the subject material should be rapidly eliminated from the body though the urine. For the purposes of risk assessment, 50% absorption following oral or dermal exposures and 100% absorption following inhalation exposures is assumed. This represents a most conservative estimate.
Reference
ASSESSMENT
Oral Bioavailability:
The subject material is a water soluble and ionizable material with a measured octanol/water partition coefficient (log) of -1.7 and a moderate molecular weight (MW=268). Such a material should readily dissolve in the gastro-intestinal fluid. However, the presence of ionizable groups will reduce the absorption potential. Given some measured systemic effects in experimental animals following oral exposures, absorption from the gastrointestinal tract cannot be precluded. Once absorbed, the highly ionized nature of the material suggests rapid elimination primarily through the urine. The material should not accumulate or bioconcentrate in tissues. However, to provide a most conservative estimate and for risk assessment purposes, a 50% absorption of the subject material by the oral route is assumed.
Dermal Bioavailability
Compounds most readily absorbed through the relatively impervious stratum corneum skin layer are those of moderate lipophilicity and having both some water and fat solubility. The subject material is highly water soluble but is of a low lipophilicity, as evidenced by a low octanol/wate partition coefficient. Such a material should not be readily absorbed through the skin. However, to provide a most conservative estimate and for risk assessment purposes, a 50% absorption of the subject material by the dermal route is assumed.
Inhalation Bioavailability
Based on the particle size distribution measured for the subject material, inhalation exposure should result primarily in deposition of material in the upper nasopharyngeal reagion of the repiratory tract and with little or no exposure of the alveolar region. However, due to subsequent uptake of the water soluble material into the mucous coating of the respiratory tract with subsequent oral exposure due to swallowing, the material should be considered to be bioavailable by the inhalation route. However, to provide a most conservative estimate and for risk assessment purposes, a 100% absorption by the inhalation route is assumed.
Description of key information
A review based on expert judgement has been performed on the subject material. For the purposes of risk assessment, 50% absorption following oral or dermal exposures and 100% absorption following inhalation exposures is assumed.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
Oral Bioavailability:
The subject material is a water soluble and ionizable material with a measured octanol/water partition coefficient (log) of -1.7 and a moderate molecular weight (MW=268). Such a material should readily dissolve in the gastro-intestinal fluid. However, the presence of ionizable groups will reduce the absorption potential. Given some measured systemic effects in experimental animals following oral exposures, absorption from the gastrointestinal tract cannot be precluded. Once absorbed, the highly ionized nature of the material suggests rapid elimination primarily through the urine. The material should not accumulate or bioconcentrate in tissues. However, to provide a most conservative estimate and for risk assessment purposes, a 50% absorption of the subject material by the oral route is assumed.
Dermal Bioavailability:
Compounds most readily absorbed through the relatively impervious stratum corneum skin layer are those of moderate lipophilicity and having both some water and fat solubility. The subject material is highly water soluble but is of a low lipophilicity, as evidenced by a low octanol/wate partition coefficient. Such a material should not be readily absorbed through the skin. However, to provide a most conservative estimate and for risk assessment purposes, a 50% absorption of the subject material by the dermal route is assumed.
Inhalation Bioavailability:
Based on the particle size distribution measured for the subject material, inhalation exposure should result primarily in deposition of material in the upper nasopharyngeal region of the respiratory tract and with little or no exposure of the alveolar region. However, due to subsequent uptake of the water soluble material into the mucous coating of the respiratory tract with subsequent oral exposure due to swallowing, the material should be considered to be bioavailable by the inhalation route. However, to provide a most conservative estimate and for risk assessment purposes, a 100% absorption by the inhalation route is assumed.
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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