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Diss Factsheets
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EC number: - | CAS number: -
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: assessment based on information available
- Adequacy of study:
- key study
- Study period:
- July 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP assessment report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
- Objective of study:
- other: toxicokinetic assessment
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An expert assessment was made based on all data available.
- GLP compliance:
- no
Test material
- Reference substance name:
- B508
- IUPAC Name:
- B508
- Details on test material:
- - Name of test material (as cited in study report: B508
- Physical state: powder
- Analytical purity: 100%
Constituent 1
Test animals
- Species:
- other: none
Administration / exposure
- Route of administration:
- other: oral, dermal and inhalation
- Vehicle:
- other: not applicable
- Details on study design:
- A toxicokinetic assessment has been performed based on available physico-chemical properties and toxicological data of the substance.
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- For risk assessment purposes, oral absorption is set at 50%, inhalation absorption is set at 100% and dermal absorption is set at 10%.
Any other information on results incl. tables
As no partition coefficient could be determined, this parameter cannot be used in the prediction of toxicokinetics of B508.
Generally, a solid has to be dissolved before it can be absorbed. The relatively high molecular weight (>500 g/mol) and the low water solubility (<0.967 mg/L) of B508 predict absorption in the gastro-intestinal tract by passive diffusion to be unlikely. In the 28-day study urine was not discoloured due to the test substance, but faeces were. Therefore, for risk assessment purposes, the oral absorption of B508 is set at 50% (1). The results of the toxicity studies do not provide reason to deviate from this proposed oral absorption percentage.
Based on the relatively high molecular weight and low water solubility B508 is expected to have a limited distribution once absorbed. Accumulation in the lungs may occur as was demonstrated in the acute inhalation study by blue foci in the lungs. As no partition coefficient could be determined no further prediction of bioaccumulation can be made. Absorbed B508 may be metabolised and/or conjugated (2). The conjugates are expected to be excreted via the faeces as they are relatively high molecular weight compounds.
The low vapour pressure (<8.40´10-7Pa) indicates that B508 is not available for inhalation as a vapour. At least 50% of particles is small enough to be inhaled and more than 10% is expected to reach the alveolar region of the respiratory tract. The low water solubility (<0.967 mg/L) enhances penetration to the lower parts of the respiratory tract where B508 might be taken up by micellular solubilisation. For risk assessment purposes the inhalation absorption of B508 is set at 100%. The result of the acute inhalation study does not provide reason to deviate from this proposed inhalation absorption percentage.
A solid has to dissolve into the surface moisture of the skin before uptake can occur. The high molecular weight and the low water solubility indicate a low expected dermal absorption of B508. According to the criteria given in the REACh guidance (1): 10% dermal absorption will be considered in case MW >500 and log Pow <-1 and >4, otherwise 100% dermal absorption should be used. Therefore, for risk assessment purposes, 10% dermal absorption of B508 is proposed.
Based on the present data, no additional conclusions can be drawn on the distribution, metabolism and excretion of B508 after dermal and inhalatory absorption.
1. Guidance for the implementation of REACH. Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance. European Chemical Agency, May 2008.
2. A. Parkinson. In: Casarett and Doull’s Toxicology, The basic science of poisons. Sixth edition. Ed. C.D. Klaassen. Chapter 6: Biotransformation of xenobiotics.,, 2001.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
For risk assessment purposes, oral absorption is set at 50%, inhalation absorption is set at 100% and dermal absorption is set at 10%.
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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