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EC number: 416-740-6 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability rating was 2 because study was conducted in accordance with generally accepted scientific principles for ADME radiolabel studies. Results from study published in peer-reviewed journal, Xenobiotica 24: 441-450 (1994).
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- other: followed generally accepted radioactivity ADME techniques
- Principles of method if other than guideline:
- General ADME study was carried out using radiolabelled chemical to investigate ADME as well as hydrolysis of the ester groups in the parent chemical.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Bis(2-ethylhexyl) terephthalate
- EC Number:
- 229-176-9
- EC Name:
- Bis(2-ethylhexyl) terephthalate
- Cas Number:
- 6422-86-2
- Molecular formula:
- C24H38O4
- IUPAC Name:
- bis(2-ethylhexyl) terephthalate
- Reference substance name:
- Di-2-ethylhexyl terephthalate
- IUPAC Name:
- Di-2-ethylhexyl terephthalate
Constituent 1
Constituent 2
- Radiolabelling:
- yes
- Remarks:
- C14 labelled in 2-ethylhexyl portion
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- [14C-ethylhexyl labelled] DEHT in corn oil by oral gavage (100 mg/kg) to 10 adult male SD rats
- Duration and frequency of treatment / exposure:
- 144 hrs
Doses / concentrations
- Dose / conc.:
- 100 other: mg/kg
- Remarks:
- Doses / Concentrations:
single oral dose (100 mg/kg) with radiolabelled [14C-ethylhexyl labelled] DEHT
- No. of animals per sex per dose / concentration:
- 10 male rats
- Control animals:
- no
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- DEHT is rapidly absorbed orally to the extent of about 36.9% based on radioactivity recovery in urine, residual carcass, expired CO2
- Details on distribution in tissues:
- Low bioaccumulation potential expected since only 1.4% radioactivity found in residual carcass
- Details on excretion:
- Radioactivity was excreted in the urine (31.9%) as terephthalic acid and other conjugated metabolites. The remainder of the radioactivity was found in the feces (56.5%) or as CO2 (3.6%) in expired air.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Metabolic hydrolysis of DEHT occurs extensively with both ester groups to yield 2-ethylhexyl alcohol and terephthalic acid and their glucuronide or sulfate conjugates. Unchanged DEHT material was found unabsorbed and unchanged in the feces (56.5%). Mono-2-ethylhexyl terephthalate was estimated to be no more than 9.3% of the radiolabelled dose.
In vitro rat intestinal homogenate study (Barber et al, 1994):
In addition, the in vitro metabolic hydrolysis rate of DEHT to free 2-ethylhexanol (2-EH) was determined using rat intestinal homogenates (Barber et al., 1994). The half-life for disappearance of the di-ester parent molecule (i.e., DEHT) was 53.3 minutes. More importantly, the stoichiometry of the reaction at termination showed that 1.97 moles of 2-EH were formed per mole of DEHT, indicating complete hydrolysis to terephthalic acid (TPA). In contrast, the stoichiometry of the reaction with DEHP (the ortho-phthalate analog) was one mole of 2-EH formed per mole of DEHP, indicating incomplete hydrolysis to mono-(2-ethylhexyl) phthalate (MEHP).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
Main findings of this ADME study indicate that both ester groups DEHT was extensively hydrolyzed to terephthalic acid and very little (ca 9.3 %) of the mono ester metabolite detected. This differs from di-2-ethylhexyl phthalate in which one only of its two diester group is hydrolyzed to the monoester phthalate metabolite, which is predominant metabolite detected. Hence, the terephthalate material undergoes complete hydrolysis of both ester groups in the gut which limits absorption of the parent material. - Executive summary:
In summary, DEHT was rapidly absorbed orally to the extent of about 36.9%. Distribution or retention in the tissues was determined to be about 1.4% at study termination. Metabolism occurred primarily via initial hydrolysis of both alkyl esters group to terephthalic acid and 2-ethylhexyl alcohol and further metabolism, conjugation and excretion of metabolites in the urine. The remainder of the radioactive dose passed through the GI tract as unabsorbed, unchanged DEHT and was recovered in the feces (56.5%) or was eliminated as14CO2in expired air.
In addition, the in vitro metabolic hydrolysis rate of DEHT to free 2-ethylhexanol (2-EH) was determined using rat intestinal homogenates (Barber et al., 1994). The half-life for disappearance of the di-ester parent molecule (i.e., DEHT) was 53.3 minutes. More importantly, the stoichiometry of the reaction at termination showed that 1.97 moles of 2-EH were formed per mole of DEHT, indicating complete hydrolysis to terephthalic acid (TPA). In contrast, the stoichiometry of the reaction with DEHP (the ortho-phthalate analog) was one mole of 2-EH formed per mole of DEHP, indicating incomplete hydrolysis to mono-(2-ethylhexyl) phthalate (MEHP).
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