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EC number: 202-338-6 | CAS number: 94-49-5
- 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
- Remarks:
- expert QSAR report
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a (Q)SAR model, with limited documentation / justification, but validity of model and reliability of prediction considered adequate based on a generally acknowledged source
- Executive summary:
Incentive
Evaluation of the toxicokinetic properties (i.e. absorption, metabolism, distribution and elimination) of the substance is a requirement. The information can contribute in the understanding of the toxicological profile and assist in testing
strategy and study design.
Objective
The purpose of this study was to assess the toxicokinetic properties of ethylene dibenzoate (EGDB, CAS 94-49-5).
Methods
The toxicokinetic properties of EGDB are evaluated using free and commercially available computerized models as well as available study information on the substance itself.
Conclusions
EGDB is a mono-constituent of at least 99.4% purity and has a molecular weight of 270.28 g/mole. It is a solid at room temperature. Based on information from property profiling as well on information on studies on EGDB, the following statements can be made:
- Oral absorption: the bioavailability of EGDB, following dissociation of the salt in the Gastro- Intestinal tract, is considered to be high via oral route. A provisional absorption rate of 100% is set for the oral route.
- Dermal absorption: Dermal absorption of EGDB is expected to be high. A provisional absorption rate of 100% is set for the dermal route.
- Respiratory absorption: Likelihood of exposure via inhalation is low considering the very low vapor pressure. Exposures are only possibly to aerosols that will deposit mainly in upper airways, and will be subsequently swallowed after mucociliary transportation to pharynx. No principal difference is therefore expected in absorption between exposures via inhalation route and oral route as high in respiratory tract. Absorption via inhalation therefore also set to 100%.
- It is predicted that EGDB is rapidly absorbed, distributed over the whole body and excreted again
- EGDB has no bioaccumulation potential (LogPow 3.75 (just above 3) and readily biodegradable).
Reference
Description of key information
Due to lack of quantitative data, absorption rates of 100% are indicated for all three routes. This basically indicates that, although the absorption is probably low, there is likely no significant difference expected in absorption between oral, dermal and inhalation route. Available studies (readily biodegradable, low log kow) do not indicate a concern for bioaccumulation.
EGDB is a mono-constituent of at least 99.4% purity and has a molecular weight of 270.28 g/mole. It is a solid at room temperature.
Based on information from property profiling as well on information on studies on EGDB, the following statements can be made:
- Oral absorption: the bioavailability of EGDB, following dissociation of the salt in the Gastro- Intestinal tract, is considered to be high via oral route. A provisional absorption rate of 100% is set for the oral route.
- Dermal absorption: Dermal absorption of EGDB is expected to be high. A provisional absorption rate of 100% is set for the dermal route.
- Respiratory absorption: Likelihood of exposure via inhalation is low considering the very low vapor pressure. Exposures are only possibly to aerosols that will deposit mainly in upper airways, and will be subsequently swallowed after mucociliary transportation to pharynx. No principal difference is therefore expected in absorption between exposures via inhalation route and oral route as high in respiratory tract. Absorption via inhalation therefore also set to 100%.
- It is predicted that EGDB is rapidly absorbed, distributed over the whole body and excreted again
- EGDB has no bioaccumulation potential (LogPow 3.75 (just above 3) and readily biodegradable).
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
From a combined OECD 422/408 study, there were some concerns raised of possible effects on thyroid function, based on a decreased T4 at 1000 mg/kg. Further studies (OECD 414 and neurodevelopmental toxicity OECD 426) did not confirm the concerns raised and confirmed a NOAEL of 1000 mg/kg bw.
Ethyleen glycol dibenzoate (EGDB) is expected to be metabolized relative quickly over the two ester bonds in analogy of the comparable substance DEGDB (Oxydiethylene dibenzoate, CAS 120-55-8).
In an OECD 417 study, virtually all DEGDB was absorbed, metabolized and excreted in urine with 24 hours of administration. Metabolism involved hydrolysis of the ester bonds to benzoic acid, which was conjugated with either glycine (major pathway) or glucuronic acid (minor pathway) prior to excretion.
The same can be expected for EGDB.
All three substances, benzoic acid, EGDB and DEGDB show a NOAEL of 1000 mg/kg bw/day from repeated dose toxicity testing.
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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