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EC number: 271-985-4 | CAS number: 68648-28-2
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Etude sur les huiles chauffées. II: Etude toxicologique et nutritionelle chez le rat des huiles d'arachide, palme, soja et tournesol
- Author:
- Coquet B, Guyot D, Fouillet X and Rouard JL
- Year:
- 1 977
- Bibliographic source:
- Revue Française des Corps Gras 10:483-488
Materials and methods
- Principles of method if other than guideline:
- A 13 week (90 d) oral combined repeated dose and reproduction / developmental screening study was conducted in Sprague Dawley rat to evaluate the reproductive parameters. After 10 weeks of treatment with 15% crude palm oil, 10 males and 20 females (15 - 16 weeks of age) were mated for 18 days. The females were then allowed to produce young. Maternal bodyweight and reproductive parameters (e.g. % implantation, % surviving young, % embryo loss, ...) were recorded. At 5 weeks of age, the young were sacrificed. One male and 2 females of each litter was autopsied. Liver and kidneys were weighed. For 5 males and 5 females selected randomly, these organs were examined microscopically.
- GLP compliance:
- no
- Limit test:
- no
Test material
- 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 (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.’
- Substance type: Triglycerides of vegetable origin
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Own breeding
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 150 g
- Housing: 5 per sex per cage
- Diet (e.g. ad libitum): 40% wheat, 20% maize, 12% fish meal, 7% blood powder, 15% oil and 6%vitamin/minerals complement
- Water (e.g. ad libitum): yes
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): every 4 - 5 days
- Storage temperature of food: 4°C - Details on mating procedure:
- After 10 weeks of treatment, 10 males and 20 females (15 - 16 weeks of age) were mated for 18 days. The females were then allowed to produce young.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- 90 d
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
15%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10 males, 20 females for the reproduction screening
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Parental animals: Observations and examinations:
- See section 7.5.1 for details on 13 WEEK FEEDING STUDY
REPRODUCTION SCREENING:
Maternal bodyweight and reproductive parameters (e.g. % implantation, %surviving young, % embryo loss, ...) were recorded. At 5 weeks of age, the young were sacrificed. One male and 2 females of each litter was autopsied. Liver and kidneys were weighed. For 5 males and 5 females selected randomly, these organs were examined microscopically. - Postmortem examinations (offspring):
- Microscopic pathology of liver and kidney of young rats were performed from the reproduction screening at 35 days of age.
- Statistics:
- No data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 15 other: % in diet equivalent to 17 - 7 g/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant toxicity on maternal rats or pups
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
Target system / organ toxicity (P1)
- Key result
- Critical effects observed:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 15 other: % in diet equivalent to 7000 - 17000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects on maternal and pups
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- not specified
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
Target system / organ toxicity (F2)
- Key result
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the NOAEL was considered to be 15% in diet, equivalent to 7000 - 17000 mg/kg bw/day, as no significant toxicity were observed on maternal rats and pups.
- Executive summary:
A combined repeated and reproductive screening study was conducted to determine the effect of glycerides, C16-18 and C18-unsatd. (in the form of crude palm oil) on rats when administered for 13 weeks at 15% in diet. Results were compared to those obtained with heated palm oil, crude/heated soy oil, crude/heated peanut oil or crude/heated sunflower oil at the same concentration. Clinical signs and bodyweight were recorded throughout the study. After 13 weeks, hematology, clinical chemistry and urinalysis parameters were assessed, as well as gross and microscopic pathology. After 10 weeks of treatment, 10 males and 20 females were mated for 18 days. Maternal bodyweight and reproductive parameters were recorded. At 5 weeks of age, the young were sacrificed. Liver and kidneys weights were recorded and these organs were examined microscopically. The test substance did not show any adverse effects on male and female rats compared to other crude or heated vegetable oils. Furthermore, no signs of toxicity were observed on maternal rats or pups in the follow-up reproductive screening trial. Under the study conditions, the NOAEL was considered to be 15% in diet, equivalent to 7000 - 17000 mg/kg bw/day, as no significant toxicity were observed on maternal rats and pups (Coquet, 1977).
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