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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
- Principles of method if other than guideline:
- Three groups of Balb/C female mice were dosed with red palm oil supernatant and red palm oil sediment and a mixture of two, respectively, for 5 consecutive d. A negative group was dosed with corn oil and the positive control group was injected intraperitoneally with cyclophosphamide. 24 h after the last treatment each animal were killed by cervical dislocation. The femurs from each animal were dissected and stripped clean of muscles, for cytological preparations from bone marrow. For each animal 100 bone marrow metaphase cells were analysed for evaluation of chromosome aberration and 1000 cells for determination of mitotic index. The types of chromosomal aberrations considered were chromatid and chromosome gaps, breaks, fragments and exchanges. The mitotic index was statistically analysed by the x^2 test and the frequency of chromosome aberration was analysed using a conditional test based on approximation to the Poissin distribution.
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
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): Red 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:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-10 wk
- Weight at study initiation: 25-30 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ̊C
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Not applicable
- Details on exposure:
- Not applicable
- Duration of treatment / exposure:
- 5 d
- Frequency of treatment:
- daily
- Post exposure period:
- None
Doses / concentrations
- Dose / conc.:
- 4 500 mg/kg bw/day
- Remarks:
- Basis:
nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Positive control(s):
- cyclophosphamide
- Route of administration: injection intraperitoneally
- Doses / concentrations: 20 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow metaphase cells
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION: The slides were stained in 10% aqueous Giemsa solution
- Evaluation criteria:
- The types of chromosomal aberrations considered were chromatid and chromosome gaps, breaks, fragments and exchanges
- Statistics:
- The mitotic index was statistically analysed by the chi square test and the frequency of chromosome aberration was analysed using a conditional test based on an approximation to the Poisson distribution.
Results and discussion
Test results
- Key result
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, test substance did not induce chromosomal aberrations in mouse bone marrow cells, in vivo, after daily expositions of 4500 mg/kg bw/d. Furthermore, this dose did not promote any alteration in the mitotic index, suggesting that test substance had no cytotoxic effects.
- Executive summary:
A study was conducted to evaluate possible clastogenic and cytotoxic activity of glycerides, C16-18 and C18-unsatd. (in the form of red palm oil) in mouse bone marrow cells in vivo. Three groups of Balb/C female mice, 10 per group, were dosed with test substance supernatant, test substance sediment or a mixture of the two at a dose level of 4500 mg/kg bw/d by gavage for 5 consecutive days. A negative group was dosed (by gavage) with corn oil and the positive control group was injected intraperitoneally with cyclophosphamide. 24 h after the last treatment each animal were killed by cervical dislocation. The femurs from each animal were dissected and stripped clean of muscles, for cytological preparations from bone marrow. For each animal 100 bone marrow metaphase cells were analysed for evaluation of chromosome aberration and 1000 cells for determination of mitotic index. No statistically significant differences were observed in the frequency of chromosomal aberrations and the mitotic index in bone marrow samples in any of the three groups. Under the study conditions, test substance did not induce chromosomal aberrations in mouse bone marrow cells, in vivo, after daily expositions of 4500 mg/kg bw/d. Furthermore, this dose did not promote any alteration in the mitotic index, suggesting that test substance had no cytotoxic effects (Oliveria, 1994).
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