Registration Dossier
Registration Dossier
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: 248-299-9 | CAS number: 27178-16-1
- 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

Carcinogenicity
Administrative data
Description of key information
In a 103-week carcinogenicity study, the read-across substance, bis(2 -ethylhexyl) adipate, was administered to F344 rats and B6C3F1 mice in the diet at 12000 or 25000 ppm.
Under the conditions of this bioassay, di(2-ethylhexyl)adipate was not carcinogenic for F344 rats.
Hepatocellular carcinomas or ademomas occurred in mice of both sexes in a dose-related fashion at incidences that were significantly higherfor high dose males and for low dose and high dose females than those in the controls. When compared with the incidence in historical laboratory control mice, however, the liver tumours in male mice could not be clearly related to the compound administration.
The test substance is not considered to be carcinogenic for the following reasons:
These tumours are very common in B6C3F1 mice.
There was no dose-response in female mice.
Time to first occurrence of the tumours was not altered by the test substance.
Observed incidences in male and female mice were well within NTP historical control data for this mouse strain.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1977- May 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- Urinalysis, haematological and clinical biochemistry measurements were not reported
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: NCI Frederick cancer Research Center, Maryland
- Age at study initiation: 3 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 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- 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 concentration 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 dietaryconcentration, the mean of the analytical concentration was usually within +/-10% of the theoretical.
- Duration of treatment / exposure:
- 103 weeks
- Frequency of treatment:
- Ad libitum
- Post exposure period:
- Week 104-107
- Dose / conc.:
- 12 000 ppm
- Dose / conc.:
- 25 000 ppm
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, plain diet
- Details on study design:
- Dose selection rationale: based on results of a subchronic pre-study (14-week study)
- Positive control:
- None
- Observations and examinations performed and frequency:
- Body weight: yes, every 4 weeks.
Clinical observations: twice daily. - Sacrifice and pathology:
- Necropsy: Carbon dioxide inhalation.
GROSS PATHOLOGY and HISTOPATHOLOGY: Yes
Gross and microscopic examinations were performed on major tissues, major organs, and all gross lesions from killed animals and from animals found dead. Tissues were preserved in 10% neutral buffered formalin, embedded in paraffin, sectioned, and stained with hematoxylin and eosin . The following tissues were examined microscopically : skin, lungs and bronchi, trachea , bone and bone marrow, spleen, lymph nodes, heart, salivary gland, liver, pancreas, stomach, small intestine, large intestine, kidneys, urinary bladder, pituitary, adrenal, thyroid, parathyroid, mammary gland, prostate and seminal vesicles or uterus, testis or ovary, brain, thymus, larynx, and esophagus. Necropsies were performed on all animals found dead unless precluded in whole or in part by autolysis or cannibalization . - Statistics:
- Probabilities of survival were estimated by the product-limit procedure of Kaplan and Meier (1958). Animals were statistically censored as of the time that they died of other than natural causes or were found to be missing ; animals dying from natural causes were not statistically censored .
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
The incidence of neoplastic or non-neoplastic lesions has been given as the ratio of the number of animals bearing such lesions at a specific anatomic site (numerator) to the number of animals in which that site is examined (denominator).
The one-tailed Fisher exact test (Cox, 1970) was used to compare the tumor incidence of a control group with that of a group of dosed animals at each dose level.
The Cochran-Armitage test for linear trend in proportions, with continuity correction (Armitage, 1971), was also used. Life table methods were used to analyze the incidence of tumors. Curves of the proportions surviving without an observed tumor were computed as in Saffiotti et al . (1972).
The approximate 95% confidence interval for the relative risk of each dose group compared with its control was calculated from the exact interval on the odds ratio (Gart, 1971). - Clinical signs:
- no effects observed
- Description (incidence and severity):
- No compound- related clinical signs were observed.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean body weights of high-dose rats of either sex were lower than those of the controls throughout the study.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Several non-neoplastic lesions were seen in control and dosed rats. None appeared to be related to the test substance.
A variery of neoplasms were seen in both controil and dosed rats. Tumours noted were those routinely seen in this strain of rat and they occurred in comparable numbers in control and dosed rats. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Several non-neoplastic lesions were seen in control and dosed rats. None appeared to be related to the test substance.
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A variery of neoplasms were seen in both controil and dosed rats. Tumours noted were those routinely seen in this strain of rat and they occurred in comparable numbers in control and dosed rats.
- Relevance of carcinogenic effects / potential:
- Under the conditions of this bioassay, di(2-ethylhexyl)adipate was not carcinogenic for F344 rats.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 12 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: 25000 ppm is considered to be equivalent to 600 mg/kg bw
- Conclusions:
- Under the conditions of this bioassay, di(2-ethylhexyl)adipate was not carcinogenic for F344 rats.
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- Please see Section 13 below.
- Reason / purpose for cross-reference:
- read-across source
- Relevance of carcinogenic effects / potential:
- Under the conditions of this bioassay, di(2-ethylhexyl)adipate was not carcinogenic for F344 rats.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 12 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Conclusions:
- Under the conditions of this bioassay, di(2-ethylhexyl)adipate was not carcinogenic for F344 rats.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 600 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Klimisch 2 study
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the above mentioned result, classification of diisodecyl adipate according to the CLP Regulation (EC) 1272/2008 is not necessary.
Additional information
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.