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Diss Factsheets
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EC number: 230-743-8 | CAS number: 7299-99-2
- 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 available information
- Adequacy of study:
- key study
- Study period:
- August 2010
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
- Objective of study:
- other: toxicokinetic assessment
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Assessment of all available data
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
- EC Number:
- 230-743-8
- EC Name:
- 2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
- Cas Number:
- 7299-99-2
- Molecular formula:
- C37H68O8
- IUPAC Name:
- 3-[(2-ethylhexanoyl)oxy]-2,2-bis({[(2-ethylhexanoyl)oxy]methyl})propyl 2-ethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): 2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate) (BEBE)
- Physical state: Clear colourless oily liquid
- Analytical purity: >80%
Constituent 1
Test animals
- Species:
- other: none
- Strain:
- other: none
Administration / exposure
- Route of administration:
- other: oral, dermal, inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- see assessment
Results and discussion
Any other information on results incl. tables
The water solubility of BEBE is very low («1 mg/L). Since in general a compound needs to be dissolved before it can be taken up from the gastro-intestinal tract, it seems unlikely that BEBE will show a high systemic exposure after oral administration (1). However, its highly lipophilic character (log Po/w > 6) indicates that uptake by micellular solubilisation may be of particular importance. For risk assessment purposes oral absorption is set at 100%. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.
Once absorbed, distribution of BEBE throughout the body will be limited by low water solubility. Intracellularcentration of BEBE is expected to be higher than extracellular concentration, based on its lipophilic character. The concentration in breast milk may be higher than in blood/plasma. As a lipophilic substance, BEBE may concentrate in adipose tissue and depending on the conditions of exposure may accumulate. Daily exposure to BEBE may result in a build up in the body. Once exposure stops, the concentration in the body will decline at a rate determined by the half-life of the substance. BEBE may be conjugated and excreted via the bile and may also undergo enterohepatic recycling (circulation of bile from the liver, where it is produced, to the small intestine, where it aids in digestion of fats and other substances, back to the liver) which will prolong its biological half-life (2).
BEBE has low volatility, i.e., very low vapour pressure (3.06´10-7Pa) and a high boiling point (415°C), and is therefore unlikely to be available for inhalation as a vapour. However, any BEBE reaching the respiratory epithelium may be taken up by micellular solubilisation, because of its highly lipophilic character (log Po/w > 6) and low water solubility. For risk assessment purposes the inhalation absorption of BEBE is set at 100%.
In view of its highly lipophilic character (log Po/w > 6),and the low water solubility («1 mg/L), the rate of transfer of BEBE between the stratum corneum and the epidermis will be slow, and uptake into the stratum corneum itself may be slow. Any substance persisting in the stratum corneum may eventually be cleared as the stratum corneum is sloughed off. A dermal absorption of 10% is proposed for risk assessment purposes.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study resultsFor riskassessment purposes the oral absorption is set at 100%For riskassessment purposes the inhalation absorption is set at 100%For riskassessment purposes the dermal absorption is set at 10%
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