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Diss Factsheets
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EC number: 445-760-8 | CAS number: 122886-55-9
- 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)
Description of key information
A toxicokinetic assessment was performed based on the available data of the substance. Based on the physical/chemical properties of the substance, absorption factors for this substance are derived to be 10% (oral), 10% (inhalation) and 10% (dermal) for risk assessment purposes. The bioaccumulation potential is expected to be low.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 10
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 10
Additional information
A toxicant can enter the body after oral exposure, by inhalation or after dermal exposure. To
determine the absorption rate, the different routes are assessed individually. In general, a
compound needs to be dissolved before it can be taken up from the gastrointestinal tract after
oral exposure. KY-EU has a low water solubility (4.38 μg/L) and therefore uptake by
passive diffusion is expected to be limited. KY-EU is a reaction mass with multiple constituents.
Based on its three main components, its weighted average molecular weight is 632.8 g/mole. This high molecular weight does not favor absorption. KY-EU has a high partition coefficient (log Pow ≥6 at 26°C), which indicates that the compound is very hydrophobic. This
characteristic allows micellular solubilisation by bile salts in the gastro-intestinal tract which
enables the substance to some extent to cross lipid biomembranes.
For risk assessment purposes oral absorption of KY-EU is set at 10%, based on its high
log Pow, low water solubility and its high molecular weight. The results of the toxicity studies do
not provide reasons to deviate from this proposed oral absorption factor.
Once absorbed, wide distribution of the test substance throughout the body is not expected
based on its low water solubility and its high molecular weight. Based on its high partition
coefficient (log Pow ≥6 at 26°C), it can generally be assumed that KY-EU will distribute into cells
and accumulate in adipose tissue. However, for highly hydrophobic substances, experimental
data demonstrate that both the bioconcentration factor and the bioaccumulation factor tend to
decrease with increasing log Pow (above 6 and above 7.5 resp.).Therefore, based on these
data, distribution and accumulation is expected to be low.
Excretion of KY-EU and its metabolites will occur via the bile (high molecular weight) or the
urine (low molecular weight; 2). The low vapour pressure of the substance (<0.00026 Pa at
25°C) indicates that KY-EU is not expected to evaporate and reach the nasopharyncheal
region or subsequently the tracheo/bronchial/pulmonary region via inhalation. Furthermore, it
has been shown that all KY-EU particles were >17 μm and approximately 92% of all particles
were >100 μm. This indicates that the presence of inhalable and/ or respirable particles will be
limited. If any particles reach the respiratory tract, particles above 50 μm are expected not to
penetrate the lower regions. If KY-EU reaches the tracheobronchial region, it is not likely to
dissolve within the mucus lining of the respiratory tract due to its low water solubility. However, if it
dissolves into the mucus lining, based on its high log Pow, it is likely that micellular solubilisation
will occur which will enable uptake of the substance by crossing of biomembranes. Based on
the above data, for risk assessment purposes the inhalation absorption of KY-EU is set at 10%.
KY-EU is a solid, thus when it comes in contact with the skin, absorption is not very likely. Due
to its very low water solubility, KY-EU will only dissolve to a limited extent in body fluids.
Furthermore, the first layer of the skin, the stratum corneum, forms a barrier for hydrophilic
compounds. KY-EU has a log Pow ≥6, suggesting that the substance is not hydrophilic and can be taken up in the stratum corneum. However, due to its low water solubility, the transfer
between the stratum corneum and the epidermis will be limited. According to the criteria given in
the REACH Guidance, 10% dermal absorption will be considered in case MW >500 and log
Pow <-1 or >4, otherwise 100% dermal absorption should be used. As the physical/chemical
properties of KY-EU meet the criteria for limited dermal absorption (MW = 632.8 g/mole (based on the
weighted average MWs of the main components) and log Pow ≥6), for risk assessment
purposes dermal absorption is set at 10%. The results of the toxicity studies do not provide
reasons to deviate from this proposed dermal absorption factor.
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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