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EC number: 282-486-6 | CAS number: 84238-17-5
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A two generation reproductive toxicity study was conducted in gerbils to assess the effects of dietary exposure to 8.75% w/w palm kernel oil (PO).
Adult Mongolian gerbils (highly resistant to atherosclerosis) and their sucklings (first generation) were randomly assigned to two groups of 5 couples each (group 1: basal diet; group 2: 8.75% w/w PO in diet). In the second generation parameters such as frequency of litters, number of pups, mean litter size, mean weight, postnatal mortality were observed. - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Glycerides, C8-18, C18-unsatd.
- IUPAC Name:
- Glycerides, C8-18, C18-unsatd.
- Reference substance name:
- Glycerides, C8-18 and C18-unsatd.
- EC Number:
- 266-946-3
- EC Name:
- Glycerides, C8-18 and C18-unsatd.
- Cas Number:
- 67701-28-4
- IUPAC Name:
- Glycerides, C8-18 and C18-unsatd.
- Details on test material:
- - Name of test material (as cited in study report): Palm kernel oil (CAS N° 8023-79-8, EC N° 232-425-4). Under the SDA nomenclature, the name of this substance is Glycerides, C8-18 and C18-unsatd.
Constituent 1
Constituent 2
Test animals
- Species:
- other: gerbil
- Strain:
- other: Mongolian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Adult gerbils and their sucklings (F1) were used at the initiation
- Housing: Housed in couples in standard laboratory cages with a wire mesh lid with food hopper. The bedding consisted of wood shavings.
- Diet (e.g. ad libitum): Diets manufactured by Hope Farms BV (Woerden, The Netherlands) were used. The test diet contained increased protein (26 %), biotin, choline, inositol and vitamin E (50 %) and, cellulose (1 %).
- Water (e.g. ad libitum): Water acidified with HCI (pH 3), ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C
- Humidity: 50 %
- Photoperiod: 10 hrs light/14 hrs dark
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- No data
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Not applicable
- Details on mating procedure:
- No data
- Duration of treatment / exposure:
- 2 generations (specific period not mentioned)
- Frequency of treatment:
- Daily
- Duration of test:
- Up to 6 months of F2 generation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
8.75% w/w
Basis:
nominal in diet
- No. of animals per sex per dose:
- 5 couples per group
- Control animals:
- yes, plain diet
- Details on study design:
- No data
Examinations
- Maternal examinations:
- No data
- Ovaries and uterine content:
- Not examined
- Fetal examinations:
- The following parameters were examined in [F2] offspring: Frequency of litters, number of pups, mean litter size, mean weight at 6 months of age andpostnatal mortality
- Statistics:
- The Student-t test for unpaired samples was used to compare the variables of the different groups. For large differences in variance between the samples, the Wilcoxon test for unpaired samples was used. p < 0.05 was considered significant.
- Indices:
- Litter frequency: calculated by dividing the total number of weeks during which the couples of gerbils within one dietary group were able to breed by the number of litters
- Historical control data:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data
Details on maternal toxic effects:
Not applicable
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- > 8.75 other: % w/w
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:not examined
Details on embryotoxic / teratogenic effects:
Not applicable
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
OFFSPRING PARAMETERS:
FREQUENCY OF LITTERS (F2): No significant effects were observed.
NUMBER OF PUPS (F2): No significant difference was observed (PO: 116 and basal diet (control): 146).
MEAN LITTER SIZE (F2): No significant difference was observed (PO: 4.7±1.7 and basal diet (control): 4.9±1.6).
POSTNATAL MORTALITY (F2): No significant mortality was observed in comparison to basal diet group ( PO: 4 % and basal diet (control): 3 %)
Applicant's summary and conclusion
- Conclusions:
- Based on the results, a NOAEC of 8.57% w/w can be considered for F2 generation (developmental effects) for the test substance.
- Executive summary:
A two generation reproductive toxicity study was conducted in Mongolian gerbils to assess the effect of the ‘glycerides, C8-18 and C18-unsatd.’ (as palm kernel oil).
Adult Mongolian gerbils (highly resistant to atherosclerosis) and their sucklings (first generation) were randomly assigned to two groups of 5 couples each (group 1: basal diet; group 2: 8.75% w/w test substance in diet). In the second generation parameters such as frequency of litters, number of pups, mean litter size, mean weight, postnatal mortality were observed.
No significant effect on frequency of litters, mean litter size, total no. of newborns, mean body weight and no postnatal mortality were found in the second generation of the test substance fed group compared to the basal dietary group.
Based on the results, a NOAEC of 8.57% w/w can be considered for F2 generation (developmental effects) for the test substance.
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