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EC number: 222-884-9 | CAS number: 3648-20-2
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March 1984 and February 1985
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Description of the method is not provided.
Data source
Reference
- Reference Type:
- publication
- Title:
- Peroxisome induction studies on seven phthalate esters
- Author:
- Barber E D
- Year:
- 1 987
- Bibliographic source:
- Toxicology and Industrial Health, vol. 3, nº 2:7-24
Materials and methods
- Principles of method if other than guideline:
- - Principle of test:
DUP was tested for its ability to produce peroxisome proliferation in the Fischer 344 rat.
- Short description of test conditions: Samples were taken from the liver of sacrificed animals and prepared for both light and electron microscopy. No details of the test method were provided.
- Parameters analysed / observed: Serum samples were assayed for both triglyceride and cholesterol. The remaining portion of the liver was homogenized and assayed for cyanide-insensitive palmitoyl-CoA oxidation, lauric acid 11-hydroxylase and lauric acid 12-hydroxylase. - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Diundecyl phthalate
- EC Number:
- 222-884-9
- EC Name:
- Diundecyl phthalate
- Cas Number:
- 3648-20-2
- Molecular formula:
- C30H50O4
- IUPAC Name:
- 1,2-diundecyl benzene-1,2-dicarboxylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): Once for the 21d treatment period - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- Continuously
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 0.3 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 1.2 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 2.5 other: %
- Remarks:
- nominal in diet
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on previous studies with DEHP performed at BIBRA.
- Positive control:
- di(2-ethylhexyl)phthalate (DEHP) at dietary concentration of 1.2% was used as internal study control.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at necropsy
- Animals fasted: Yes
- How many animals: all
- Parameters examined. serum triglycerides & total cholesterol - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Biochemical analysis of the liver:
Transmission electron microscopy
Cyanide-insensitive palmitoyl-CoA oxidation was measured by the method of Gray et al. (1983). Lauric acid 11- and 12-hydroxylases were measured in washed microsomal preparations (Lake et al., 1984).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs attributed to treatment.
- Mortality:
- no mortality observed
- Description (incidence):
- No deaths occurred during the study.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduction in body weight gains was observed compared to the controls.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Serum triglyceride & cholesterol levels in DUP treated male rats were lower than the controls.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver weight (absolute & relative) in rats given DUP were significantly higher than those of controls.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Hepatic enzyme levels: There was a significant increase in cyanide insensitive palmitoyl-CoA oxidation and significant increases of lauric acid 11 and 12 hydroxylase activities.
Electron microscopy: there was a moderate increase in peroxisomes.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The substance caused a moderate proliferation of peroxisomes in the liver of rats following repeated exposure over 21 days. This is in agreement with effects described with other phthalate esters.
- Executive summary:
DUP was tested for its ability to produce peroxisome proliferation in Fischer 344 rats. DUP was administered in the diet of 5 females and 5 males per group for a period of 21 days at levels of 2.5%, 1.2% and 0.3%. DEHP at dose of 1.2% was used as a study control group as well as a negative (undosed) control group. The rats given DEHP responded as expected to a known peroxisome proliferator therefore the results obtained with DUP were regarded as valid. The electron microscopic examination of samples of liver from rats showed it to cause a moderate proliferation of peroxisomes. This was accompanied to various extents at all dose levels by, changes in other measurements that have been associated with peroxisome stimulation. These measurements were liver weight increases (absolute and relative to bodyweight), greater activities of palmitoyl CoA oxidation and lauric acid hydroxylation and, in males, lower concentrations of serum triglycerides and cholesterol.
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