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EC number: 220-836-1 | CAS number: 2915-57-3
- 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
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:
- weight of evidence
- Study period:
- April 1977 to May 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study conducted to sound scientific principles with the read across substance, bis(2-ethylhexyl) adipate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
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:
- (environmental paprmeters were outside guideline ranges, the chronic toxicity studies were not long enough in duration, only two dose levels were used in the main study and heamotology and blood parameters were not analysed)
- GLP compliance:
- no
- Limit test:
- no
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
- Appearance: clear, colourless liquid
- Storage condition of test material: stored at 4 °C in original container
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, USA
- Age at study initiation: 4 weeks
- Housing: 5 animals per cage in solid bottom suspended polycarbonate cages
- Diet: powdered Wayne® Lab Blox diet, ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 31 °C
- Humidity (%): 10 - 88 %
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
Test diets were prepared by mixing the test material with an aliquot of diet, the mixture was then placed into a Patterson-Kelly® twin-shell intennsifier bar V-blender with the remainder of the feed, and mixed for 10 minutes.
- Storage temperature of food: Test diets were dealed in labelled plastic bags and stored at 4 °C for no longer than 14 days.
Stability of test material in feed was determined by analysing sample diet mixtures containing 100,000 ppm test material that had been stored at -20, 5, 25 or 45 °C for 2 weeks. The amounts of test material found to be present by vapour-phase chromatography indicate that the test material was stable in feed for 2 weeks at temperatures as high as 45 °C. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The amounts of test material in selected batches of feed were measured by vapour-phase chromatography. 2 g samples of feed were extracted with 50 mL portions of methanol. The supernatant solutions were combined and diluted to a volume of 100 mL and analysed by vapour-phase chromatography using the following system:
- Instrument: Bendix 2500
- Column: 3 % OV-17 on 80/100 Supelcoport, glass, 1.8 m x 4 mm ID
- Oven temperature: 250 °C
- Retention time of test material: 1.9 minutes
- Inlet temperature: 235 °C
- Detctor temerature: 250 °C - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1600, 3100, 6300, 12500, 25000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10 males and 10 females per dose
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: dose selection for the 13 week repeated dose toxicity study was based on findings of the preceding acute and 14 day repeated dose toxicity studies (see below)
ACUTE TOXICITY STUDY
The estimated LD50 for male and female rats was 15.0 and 24.6 g/kg, respectively.
14 DAY REPEATED DOSE TOXICITY STUDY
All female mice fed 100,000 ppm died. Weight loss occurred among male mice fed 50,000 ppm and females fed 25,000 ppm or more. Feed consumption was reduced in females fed 100,000 ppm..
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes
FOOD EFFICIENCY: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- SACRIFICE
At the end of the 91 day study, survivors were sacrificed. Necropsies were performed on all animals, and tissues were taken for histopathological analysis.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- 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 specified
- Histopathological findings: non-neoplastic:
- no effects observed
- 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 6,300 or 25,000 ppm. No treatement-related histopathologic effects or reduction in feed consumption were observed.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 600 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Decreased body weight gain.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Dosage, Survival, and Mean Body Weight Data
Sex |
Males |
Females |
||||||||
Dose (ppm) |
Survival |
Mean body weight (g) |
Weight change relative to controls (%) |
Survival |
Mean body weight (g) |
Weight change relative to controls (%) |
||||
Initial |
Final |
Gain |
Initial |
Final |
Gain |
|||||
0 |
10/10 |
20.2 |
33.3 |
13.1 |
10/10 |
16.8 |
25.3 |
8.5 |
||
1,600 |
10/10 |
20.7 |
33.5 |
13.5 |
3.1 |
10/10 |
16.8 |
25.0 |
8.2 |
-3.5 |
3,100 |
10/10 |
20.7 |
30.7 |
10.0 |
-24 |
10/10 |
16.8 |
25.6 |
8.8 |
3.5 |
6,300 |
10/10 |
20.7 |
32.4 |
11.7 |
-10.7 |
10/10 |
16.8 |
21.5 |
4.7 |
-45 |
12,500 |
10/10 |
20.7 |
31.8 |
11.1 |
-15.3 |
9/10 * |
16.8 |
25.8 |
9.0 |
5.6 |
25,000 |
10/10 |
20.7 |
30.5 |
9.8 |
-25.2 |
10/10 |
16.8 |
24.2 |
7.4 |
-13 |
* accidental death
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the No Observed Adverse Effect Level was determined to be 1,600 ppm, based on decreased body weight gain, which is equivalent to approximately 200 mg/kg bw/day for male and female mice.
- Executive summary:
The repeated dose toxixcity of the test material was determined in a non-GLP study. During the test, groups of 10 male and 10 female mice were administered with test material in the diet at dose levels of 0 (plain diet), 1,600, 3,100, 6,300, 12,500 and 25,000 ppm, for a period of 13 weeks. Clinical observations were performed twice daily and body weights were recorded weekly. At the end of the 91 day study, survivors were sacrificed. Necropsies were performed on all animals, and tissues were taken for histopathological analysis.
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 6,300 or 25,000 ppm. No treatement-related histopathologic effects or reduction in feed consumption were observed. Under the conditions of the study, the No Observed Adverse Effect Level was determined to be 1,600 ppm, based on decreased body weight gain, which is equivalent to approximately 200 mg/kg bw/day for male and female mice.
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