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EC number: 272-211-8 | CAS number: 68783-88-0 Complex combination obtained by steam distillation of soybean oil followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
- 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
- Study period:
- Not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
- Principles of method if other than guideline:
- Groups of 30 (15 male and 15 female) weanling rats were fed diets containing 10% of either crude palm oil, groundnut oil or refined palm olein oil and adequate amounts of all other nutrients for 90 days. Food intake and bodyweight were monitored weekly. At the end of the experiment, cholesterol and triglycerides of serumm, liver and heart of all animals were analysed and compared statistically.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Glycerides, C16-18 and C18 unsatd.
- IUPAC Name:
- Glycerides, C16-18 and C18 unsatd.
- Reference substance name:
- Glycerides, C16-18 and C18-unsatd.
- EC Number:
- 266-948-4
- EC Name:
- Glycerides, C16-18 and C18-unsatd.
- Cas Number:
- 67701-30-8
- IUPAC Name:
- Glycerides, C16-18 and C18-unsatd.
- Details on test material:
- - Name of test material (as cited in study report): Crude palm oil (obtained from the Regional Research Laboratories, CSIR, at Trivandrum) (CAS N° 8002-75-3, EC N° 232-316-1); under the SDA nomenclature the name of this substance is 'Glycerides, C16-18 and C18 unsatd.'
- Other: Refined groundnut oil (control) (purchased from a local market (imported from Malaysia).
Refined palm olein oil (control) (purchased from a local market (imported from Malaysia)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The National Research Council's guide for the care and use of laboratory animals was followed.
Diet and water were given ad libitum.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- 90 days exposure and the rats were divided as followed:
Group 1: Protein free group
Group 2: 20% casein protein with 10% groundnut oil
Group 3: 20% casein protein with 10% crude palm oil
Group 4: 20% casein protein with 10% refined palm olein oil - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15
- Control animals:
- yes
- Details on study design:
- No
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- Body weights and food intake were recorded weekly
- Sacrifice and pathology:
- Cholesterol and triglycerides of serum, liver and heart of the animals were analyzed and statistically compared amongst groups.
- Other examinations:
- None
- Statistics:
- No data
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):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- The crude palm oil and refined palm oil-fed animals showed higher concentrations of cholesterol than did the groundnut oil-fed animals, though these difference were not found to be statistically significant. The triglyceride concentrations of the crude palm oil and refined groups remained higher, whereas all other parameters had comparable values among different groups.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 10 other: % in diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effect on growth rate, feed efficiency ratio, net protein utilization, digetstibility, fat absorption, nitrogen balance, phosphosour and calcium retention, lipid profiles, serum enzymes and hematology)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Groundnut oil, gain in body weight in 28 days (n=10): 215.6 ± 14.8
Crude palm oil, gain in body weight in 28 days (n=10): 196.5 ± 14.8
Palm-olein oil, gain in body weight in 28 days (n=10): 196.2 ± 13.8
Groundnut oil, feed efficiency ratio: 19.8
Crude palm oil, feed efficiency ratio: 18.5
Refined palm-olein oil, feed efficiency ratio: 18.9
Serum, Cholesterol (mmol/L)
Groundnut oil: 2.39 ± 0.18
Crude palm oil: 2.38 ± 0.46
Refined palm oil: 2.15 ± 0.53
Serum, Triglycerides (mmol/L)
Groundnut oil: 1.08 ± 0.18
Crude palm oil: 1.43 ± 0.23
Refined palm oil: 1.39 ± 0.24
Liver, Cholesterol (mmol/L of total lipid)
Groundnut oil: 114.8 ± 2.84*
Crude palm oil: 132.4 ± 5.17*
Refined palm oil: 173.8 ± 2.84
Liver, Triglycerides (mmol/L of total lipid)
Groundnut oil: 19.8 ± 2.03
Crude palm oil: 20.8 ± 2.60
Refined palm oil: 20.8 ± 2.82
Heart, Cholesterol (mmol/L of total lipid)
Groundnut oil: 60.3 ± 0.78*
Crude palm oil: 68.0 ± 0.52*
Refined palm oil: 44.9 ± 0.26
Heart, Triglycerides (mmol/L of total lipid)
Groundnut oil: 25.4 ± 1.02
Crude palm oil: 29.0 ± 0.90
Refined palm oil: 25.5 ± 0.79
* Significantly different from refined palm oil value, P < 0.05.
Applicant's summary and conclusion
- Conclusions:
- The study suggests that the test substance has adequate nutritional value compared to groundnut and palm olein oil. A NOAEL of 10 palm oil in diet was established.
- Executive summary:
A study was conducted to evaluate the nutritional effects and safety of crude ‘glycerides, C16-18 and C18-unsatd.’ (as palm oil) in rat.
The test substance was administered through the diet to groups of fifteen male and female rats for up to 90 consecutive days at dose levels of 10%.
No adverse effects compared to controls were observed as judged by growth rate, feed efficiency ratio, protein efficiency ratio, net protein utilization, digestibility, fat absorption, nitrogen balance, phosphorous and calciul retention, serum enzymes and hematology. There was also no difference in lipid concentrations compared to controls.
The study suggests that the test substance has adequate nutritional value compared to groundnut and palm olein oil.
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