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EC number: 946-420-6 | CAS number: -
- 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:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Subacute Oral Toxicity of Polyglaycerol Ester
- Author:
- King, W.R., Michael, W.R., Coots, R.H.
- Year:
- 1 971
- Bibliographic source:
- Toxicology and Applied Pharmacology, 20, 327-333
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:
- missing details on test material, no ophthalmologic or neurobehavioral examinations
- GLP compliance:
- no
Test material
- Reference substance name:
- Decaoleic acid, decaester with decaglycerol
- EC Number:
- 234-316-7
- EC Name:
- Decaoleic acid, decaester with decaglycerol
- Cas Number:
- 11094-60-3
- Molecular formula:
- C210H382O31
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: 72 g (males), 69 g (females)
- Housing: individually
- Diet (e.g. ad libitum): ad libitum (except for periods of urine collection)
- Water (e.g. ad libitum): ad libitum (except for periods of urine collection)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- continuously (except during urine collection)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2.5 other: % in diet
- Remarks:
- approx. 950 mg/kg bw/d in males and 1300 mg/kg bw/d in females
- Dose / conc.:
- 5 other: % in diet
- Remarks:
- approx. 1900 mg/kg bw/d in males and 2900 mg/kg bw/d in females
- Dose / conc.:
- 10 other: % in diet
- Remarks:
- approx. 4100 mg/kg bw/d in males and 5200 mg/kg bw/d in females
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: not specified
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: not specified
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time
-weighted averages from the consumption and body weight gain data: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: during fifth and eleventh week and from severed neck vessels at necropsy
- Anaesthetic used for blood collection: No data
- Animals fasted: No
- How many animals: all animals
- Parameters: Hemoglobin, Hematocrit, RBC count, WBC count, lymphocytes, neutrophils, monocytes, eosinophils
URINALYSIS: Yes
- Time schedule for collection of urine: during third and ninth week of the study
- Metabolism cages used for collection of urine: No data
- Animals fasted: Yes
- Parameters examined: total nitrogen, specific gravity and pH
NEUROBEHAVIOURAL EXAMINATION: Yes
- Dose groups that were examined: not specified
OTHER:
- collection of feces during fourth and tenth week for determination of total fatty acid (TFA) absorption - Sacrifice and pathology:
- At the end of the 90-day period, each animal was killed by decapitation, a gross autopsy was performed and the testes or ovaries, adrenals, kidneys, spleen, liver, lung, heart, and brain were removed and weighed. Sections from these organs along with portions of the stomach, small intestine, urinary bladder, pancreas, esophagus, trachea, thyroid, mesenteric lymph node, and perirenal and epididymal fat were fixed in Bouin solution, mounted in paraffin, and stained with hematoxylin and eosin (H & E) for histologic examination.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Males fed PGE at the high dietary level (10 %) consumed more food and had a poorer feed efficiency value than did male control animals. However, these animals consumed enough food to maintain normal growth in spite of the decreased feed efficiency.
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- Males fed PGE at the high dietary level (10 %) consumed more food and had a poorer feed efficiency value than did male control animals. However, these animals consumed enough food to maintain normal growth in spite of the decreased feed efficiency.
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Values from each sampling period generally fell within normal ranges (Burns and DeLannoy, 1966, Altman and Ditmer, 1964), and there were no indications of any blood disorder. Some values were significantly different from the SBO controls (P < 0.05); however, the differences were usually quite small and in no case established any trend or pattern indicative of a dose-related effect. As in the previous study (King et al., 1971), total
leukocyte counts obtained from tail blood in all groups were appreciably higher than corresponding values obtained from blood taken at necropsy. These data confirm those of Quimby and Goff (1952) that peripheral blood contains an increased number of luekocytes as compared to heart blood of rats. - Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- higher nitrogen excretion in females fed 10 % PGE, but no changes during the histologic examination of the urinary tract were found
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Organ weights (both absolute and as a percentage of the body weight) were not remarkable, and there were no statistically significant differences (P > 0.05) between the SBO control and experimental groups
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- At necropsy, the only gross observation of significance was what appeared to be very mild, chronic murine pneumonia in 18 ‘4 of the animals. The affected animals were scattered throughout all groups and the condition was not related to the feeding of PGE.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Microscopic examination of the various organs and tissues confirmed the pneumonitis observed grossly but did not reveal any histopathologic changes interpreted as evidence of toxicity.
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- It may be seen that the percentage of dietary fatty acids absorbed decreased as the level of PGE in the diet was increased. In all cases, fat absorption by animals fed PGE at the 5 and 10% dietary levels was significantly less than corresponding SBO control values. Absorption in animals fed the lowest level of the test material (2.5 %) was also less than that observed in the soybean oil-fed controls, but the differences were not uniformly significant. Values from animals in the group fed free oleic acid and glycerol fell between those of the 5 % PGE and SBO control groups.
Gas-liquid chromatographic (GLC) analyses of fecal fatty acids showed that excretion of oleic acid increased in a dose-related fashion : the oleic acid content of fecal fatty acids from animals fed the SBO control diet was 23 % compared to 32,41, and 51% when PGE was fed at levels of 2.5, 5.0, and lo%, respectively. It should be remembered that oleic acid (C,,l=) was the major fatty acid constituent (56 %) of the PGE product (Table 1). The increased excretion of fatty acids in general, and oleic acid in particular, shows that absorption of dietary PGE was not complete. The fecal oleic acid may have resulted from the excretion of intact PGE or from hydrolyzed or partially hydrolyzed but unabsorbed material. The oleic acid content of fecal fatty acids from animals fed free oleic and glycerol was 41x, corresponding exactly to the 5 % PGE group.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- ca. 950 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: decreased total fat absorption at 5 and 10%
- Remarks on result:
- other: 2.5% in diet
- Dose descriptor:
- NOEL
- Effect level:
- 1 300 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: decreased total fat absorption at 5 and 10%
- Remarks on result:
- other: 2.5% in diet
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Polyglycerol ester (deca-glycerol deca-oleate) was fed to rats at dietary levels of 2.5, 5.0, and 10 % for 90 days. All animals appeared to be in excellent health throughout the study, and no adverse effects were found
upon survival, growth, organ weights, organ : body weight ratios, and hematologic values. There were no significant gross or microscopic tissue changesw hich could be attributed to dietary treatment.
Total fat absorption, as measured by fecal fatty acids, decreasedin a dose-related response. This resulted in a decreased utilization of feed by males fed PGE at the 10 % dietary level. These data show that absorption of
PGE was not complete.
Excretion of nitrogen in the urine by females fed PGE at the 10% dietary level was significantly greater than the control value during both the third and ninth collection periods. The reason for this difference is not understood
at the time of this study.
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