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EC number: 271-880-3 | CAS number: 68610-90-2
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Reference Type:
- secondary source
- Title:
- Diesters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)
- Author:
- US-EPA (American Chemistry Council's Aliphatic Esters Panel)
- Year:
- 2 010
- Bibliographic source:
- High Production Volume (HPV) Chemical Challenge Program (201-16837A and 201-16837B)
- Reference Type:
- secondary source
- Title:
- Bis(2-ethylhexyl)adipate (DEHA) CAS N°: 103-23-1
- Author:
- OECD
- Year:
- 2 000
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 10; Tokyo, Japan, 15-17 March 2000
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 haematology and clinical chemistry
- 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
- Physical state: clear, colorless liquid
- Analytical purity: 100.5 % for Lot. No. 0-62-494 and 101.4 % for No. GC-2-27-76 (determined by ester titration)
- Lot/batch No.: GC-2-27-76
- Storage condition of test material: at 4°C
Constituent 1
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 Research Center, Frederick, Maryland.
- Age at study initiation: 4 weeks old.
- Housing: 5 per cage in solid bottom suspended polycarbonate cages equipped with disposable nonwoven fiber filter sheets and Aspen-bed hardwood chips as bedding.
- Diet: powdered Wayne Lab Blox diet, ad libitum.
- Water: available via an Edstrom automatic watering system, ad libitum.
- Acclimation period: 2 weeks.
ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 31 °C.
- Humidity: 10 - 88 %.
- Air changes: 10 per hr.
- Photoperiod12 hrs dark /12 hrs light.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): at least every 14 days.
- Mixing appropriate amounts with (Type of food): chemical was mixed with aliquot of powdered Wayne Lab Blox animal feed, placing the mixture in a Petterson-Kelly twin-shell intensifier bar V-blender with the remainder of the feed and mix for 10 minutes.
- Storage temperature of food: 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 the test substance in 12500 and 25000 ppm samples were determined by vapour phase chromatography. One-gram samples of each of the above mixtures were triturated twice with 50-mL portions of methanol. The supernatant solutions were combined and diluted to a volume of 100 ml and analyzed. The mean of the analytical concentration was usually within 10 % of the theoretical.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1600, 3100, 6300, 12500, 25000 ppm
Basis: nominal in diet
- Remarks:
- Doses / Concentrations:
200, 387, 787, 1562, and 3125 mg/kg bw
Basis: actual ingested (recalculated based on food consumption). Only the corresponding value to 1600 ppm were given in the study report. The other doses were calculated with the mean food consumption used to calculate this given value.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: doses used are based on an acute study and a 14-day study (groups of five mice per sex were treated with five dose levels of the test substance in feed -up to 25000 ppm- for 14 days, followed by 1 day of observation with control diet. 1 group per sex were maintained as untreated controls. All surviving animals were killed after 15 days).
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE & CLINICAL OBSERVATIONS: yes
- Time schedule: twice daily
BODY WEIGHT: yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- no specifics given on how feed consumption was observed - Sacrifice and pathology:
- GROSS PATHOLOGY: yes
HISTOPATHOLOGY: yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 1 female died (12500 ppm)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- body weight depression in males (from 3100 ppm) and females (from 6300 ppm)
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
One mouse died as a result of an accident.
BODY WEIGHT AND WEIGHT GAIN
Weight gain depression was 10 % or more for male mice fed 3100 ppm or more. Weight gain depression was 10 % or more for female mice fed 6300 or 25000 ppm.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
No compound-related reduction in feed consumption was observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
No compound-related histopathological effects were observed.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decreased body weight gain at 387 mg/kg bw/day
- Dose descriptor:
- NOAEL
- Effect level:
- 1 600 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decreased body weight gain at 3100 ppm
- Dose descriptor:
- LOAEL
- Effect level:
- 387 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decreased body weight gain
- Dose descriptor:
- LOAEL
- Effect level:
- 3 100 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decreased body weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- 387 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: decreased body weight gain at 787 mg/kg bw/day
- Dose descriptor:
- NOAEL
- Effect level:
- 3 100 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: decreased body weight gain at 6300 ppm
- Dose descriptor:
- LOAEL
- Effect level:
- 787 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: decreased body weight gain
- Dose descriptor:
- LOAEL
- Effect level:
- 6 300 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: decreased body weight gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL (males, mice) = 200 mg/kg bw/day
LOAEL (males, mice) = 387 mg/kg bw/day
NOAEL (females, mice) = 387 mg/kg bw/day
LOAEL (females, mice) = 787 mg/kg bw/day - Executive summary:
A subchronic oral toxicity study similar to OECD 408 was performed with the structurally analogue substance in B6C3F1 mice at dose levels of 1600, 3100, 6300, 12500 and 25000 ppm for a period of 90 days. Ten animals per sex and dose received the test substance daily via diet, whereas a similar constituted control group was administered the plain diet.
No signs of toxic effects and no mortality were observed in any of the animals during the study period. An adverse decrease in body weight gain compared to controls was noted starting at 3100 ppm in males and at 6300 or 25000 ppm in females, respectively. Average food consumption was not altered between treated and control groups of both genders. No adverse effects were noted at histopathological examination while clinical chemistry and haematological parameters were not reported in this study.
Based on these results, a NOAEL of 1600 ppm was derived for male B6C3F1 mice, corresponding to an actual ingested dose of 200 mg/kg bw/day. NOAEL for female mice was found to be 387 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.
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