Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 413-390-6 | CAS number: 149144-85-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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: Peer reviewed near guideline study; a study report on acute and (sub)chronic studies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no data on heamatology and clinical chemistry
- GLP compliance:
- no
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Supplier: W.R. Grace Co.(Fords, NJ)
- Name of test material (as cited in study report): di(2-ethylhexyl)adipate
- Substance type: a clear colourless liquid
- Analytical purity: 100.4% (ester titration)
- Lot/batch No.: GC-2-27-76
- Storage condition of test material: at 4 degrees Celcius
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: NCI Frederick cancer institute
- Age at study initiation: 4 weeks
- Housing: 5 per cage
- Diet :e.g. ad libitum
- Water :e.g. ad libitum
- Acclimatisation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-31
- Humidity (%): 10-88
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Dietary preparation:
Test diets were prepared by mixing the chemical with an aliquot of powdered
Wayne® Lab Blox animal feed (Allied Mills, Chicago, IL), placing the
mixture in a Patterson-Kelly twin-shell intensifier bar V-blender with the
remainder of the feed, and mixing for 10 minutes . Test diets were sealed in
labelled plastic bags and stored at 4°C for no longer than 14 days. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The amounts of di(2-ethylhexyl)adipate in selected batches of feed were measured by vapor-phase chromatography of 50-ml methanol extracts of 2-g samples. At each dietary concentration, the mean of the analytical concentration was usually within +/-10% of the theoretical.
- Duration of treatment / exposure:
- Duration of treatment: 91 days
- Frequency of treatment:
- Frequency of treatment: daily (ad libitum)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1600, 3100, 6300, 12500, 25000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1600 ppm = approx. 200 mg/kg bw/day
Basis:
other: recalculated based on REACH guidance
- No. of animals per sex per dose:
- 10 male and 10 female mice per dose.
- Control animals:
- yes, plain diet
- Details on study design:
- No further details were described.
- Positive control:
- No positive control was used.
Examinations
- Observations and examinations performed and frequency:
- Survival, body weight, histopathologic analysis and and feed consumption were assessed.
Clinical observations were
made twice daily and animals were weighed weekly. - Sacrifice and pathology:
- At the end of the 91-day
study, survivors were killed, necropsies were performed on all animals, and
tissues were taken for histopathologic analysis . - Other examinations:
- No other examinations were performed.
- Statistics:
- Statistical analyses for a possible dose-related effect on survival used the method of Cox (1972) for testing two groups for equality and Tarone's (1975) extension of Cox's methods for testing for a dose-related trend . One-tailed P values have been reported for all tests except the departure from linearity test, which is reported only when its two-tailed P value is less than 0 .05.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- One female mouse died as a result of an accident . Weight gain
depression was 10% or more for male mice fed 3,100 ppm or more . Weight gain
depression was 10% or more for females fed 6,000 or 25,000 ppm . No compound-related
histopathologic effects or reduction in feed consumption were observed.
High and low doses selected for the chronic study with mice were 12,000
ppm and 25,000 ppm di(2-ethylhexyl)adipate in feed .
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 600 ppm
- Sex:
- male/female
- Basis for effect level:
- other: Decreased body weight gain. Recalculated to be approx. 200 mg/kg bw/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
The read-across substance DEHA was investigated in an oral subchronic study on rats. The NOAEL is 1600 ppm (converted to ca. 200 mg/kg bw/day).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.