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EC number: 268-083-8 | CAS number: 68002-70-0 This substance is identified by SDA Substance Name: C16-C22 trialkyl glyceride and SDA Reporting Number: 21-001-00.
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A 13 wks (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 soy 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
Test material
- Reference substance name:
- Glycerides, C16-18 and C18-unsatd.
- IUPAC Name:
- Glycerides, C16-18 and C18-unsatd.
- Reference substance name:
- 67701-30-8
- Cas Number:
- 67701-30-8
- IUPAC Name:
- 67701-30-8
- Reference substance name:
- Glycerides, C16-18 and C18-unsatd.
- EC Number:
- 266-948-4
- EC Name:
- Glycerides, C16-18 and C18-unsatd.
- IUPAC Name:
- 266-948-4
- Details on test material:
- - Name of test material (as cited in study report): Crude soy oil (CAS N° 8001-22-7, EC N° 232-274-4). Under the SDA nomenclature, the name of this substance is ‘Glycerides, C16-18 and C18-unsatd.’
- Substance type: Triglycerides of vegetable origin
Constituent 1
Constituent 2
Constituent 3
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:
- acetone
- Details on exposure:
- 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:
- 13 wks (90 d)
- Frequency of treatment:
- Daily
Doses / concentrations
- Dose / conc.:
- 15 other: %
- Remarks:
- 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 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
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 15 other: % in diet (equivalent to 7-17 g/kg bw/d)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no significant toxicity were observed on maternal rats or pups
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the NOAEL can be considered to be 15% in diet, equivalent to 17 - 7 g/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 crude soy 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.
Crude soy oil did not show any adverse effects on male and female rats compared to other crude or heated vegetable oils when administered for 13 weeks at 15% in diet. Furthermore, no signs of toxicity were observed on maternal rats or pups in the follow-up reproductive screening trial.
The NOAEL can be considered to be 15% in diet, equivalent to 17 - 7 g/kg bw/day, as no significant toxicity were observed on maternal rats and pups.
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