Registration Dossier
Registration Dossier
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EC number: 222-037-3 | CAS number: 3323-53-3
- 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 in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- In vivo and in vitro metabolism of di-(2-ethylhexyl) adipate a peroxisome proliferator, in the rat
- Author:
- Cornu MC et al
- Year:
- 1 988
- Bibliographic source:
- Arch Toxicol Suppl 12: 265-268.
Materials and methods
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- In Vivo Studies: Different doses of DEHA were administered by gavage to Wistar male rats for 5 days. Urine was collected each morning and metabolites were extracted.
In Vitro Studies: Hepatocytes were isolated by a two step in situ perfusion technique. The test substance dissolved in dimethyl formamide was added to the cultivated monolayers 24 h after seeding and added at each 24 h medium change. Medium metabolites were extracted.
Methods of Analysis of Biological Extracts: Glucuronides as their methyl and trimethylsilyl derivatives were identified by gas chromatography/mass spectrometry. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- - Name of test material (as cited in study report): Di(2-ethylhexyl)adipate (DEHA)
No further data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration and frequency of treatment / exposure:
- single dose
Doses / concentrationsopen allclose all
- Dose / conc.:
- 665 mg/kg bw (total dose)
- Dose / conc.:
- 1 500 mg/kg bw (total dose)
- Details on dosing and sampling:
- Different doses of DEHA were administered by gavage to Wistar male rats for 5 days. Control animals received the vehicle alone (0.5 ml corn oil). Urine was collected each morning and extracted.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- After 24 h, no DEHA is recovered in rat urine.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Adipic acid is the main metabolite of DEHA. Only the EH metabolic pathway shows further metabolites, mainly EHA, which is either conjugated or submitted to omega and omega-1 pathways, giving respectively 2-ethyl hexanedioic acid and 2-ethyl-5-hydroxyhexanoic acid. The identification of all metabolites was in agreement with those in previous EH metabolism study. According to the authors, it appears that EHA glucuronidation is dose and time dependent but that EH glucuronidation is more stable.
See also attached file.
Applicant's summary and conclusion
- Executive summary:
After oral administration of 665 or 1500 mg di(2-ethylhexyl) adipate/kg bw to male rats up to 95 % of the theoretical amount from Di(2 -ethylhexyl)adipate (DEHA) was found as adipic acid in urine on day 1 after dosing. The urinary recovery was about 50%. Carbon dioxide (CO2) exhalation was not studied. Other metabolites were oxidized and conjugated forms of 2-ethyl hexanoic acid.
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