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Diss Factsheets
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EC number: 251-646-7 | CAS number: 33703-08-1
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- endocrine system modulation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- 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:
- Unnamed
- Year:
- 2 007
Materials and methods
- Type of method:
- in vivo
- Endpoint addressed:
- toxicity to reproduction / fertility
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
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Di-(2-ethylhexyl) adipate (DEHA)
- Physical state: colorless liquid
- Analytical purity: 99%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory Animal Resources, Korea Food and Drug Administration, National Institute of Toxicological Research
- Age at study initiation: 20 days
- Weight at study initiation:
- Body weight differences was less than 5g between all rats
- Diet (e.g. ad libitum): pelletized soy-bean oil-free feed AIN-76A ad lib.
- Water (e.g. ad libitum): distilled water ad lib.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- 3 days (animals were killed on day 4 of the experiment)
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 40 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- 100mg/kg BrdU was administered 1h prior to necropsy
Examinations
- Examinations:
- Serum FSH and LH levels
Organ weights (Kidney, Liver, Ovary, Vagina, Uterus) + Body weight
Histopathology of all organs relating to the endocrine system (such as uterus, liver, thyroid, pituitary, adrenals)
BrDU labelling to investigate cell proliferation in the reproductive organs including liver. - Positive control:
- 1µg/kg/day estradiol-3-benzoate in corn oil
Results and discussion
- Details on results:
- DEHA did not influence the levels of serum FSH and LH, and uterine morphological changes such as luminal epithelial height, myometrial thickness and numbers of uterine gland. Histopathology revealed no differences compared to the control group. There were no hints for increased cell proliferation in the reproductive organs including liver and uterus as determined by BrdU.
Absolute organ weights were comparable to the control group. The slightly reduced body weight in the high dose group led to a slight increase in relative kidney and ovary weight.
The positive control substance estradiol-3-benzoate led to the expected increase in uterine luminal height, uterine cell proliferation and uterus weight.
Applicant's summary and conclusion
- Conclusions:
- In this uterotrophic assay in immature rats, there was no significant variation by DEHA treatment, suggesting that DEHA appears not to be an endocrine disrupter. There were no hints for estrogenic activity after exposure for up to a dose of 1000mg/kg for 3 days.
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