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EC number: 270-700-0 | CAS number: 68476-80-2 Complex combination obtained by steam distillation of mixed vegetable oils 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final report on the safety assessment of Elaeis Guineensis (palm) oil, Elaeis Guineensis (palm) kernel oil, hydrogenated palm oil and hydrogenated palm kernel oil
- Author:
- Cosmetics Ingredients Review (CIR) Panel
- Year:
- 2 000
- Bibliographic source:
- Int. J. Toxicol. 19(2):7-28
Materials and methods
- Principles of method if other than guideline:
- The skin sensitization potential of the constituent palm oil was evaluated in the Magnusson-Kligman maximization test. The induction phase consisted of intradermal injection of 5% palm oil followed by epicutaneous application of 100% palm oil as booster. All the groups were challenged with 0.5 mL 5% palm oil. Reactions were observed 24 and 48 h after patch removal.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Conducted prior to the mandate of in vitro test requirement
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): 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
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- No. of animals per dose:
- 10 animals in both control and test groups
- Details on study design:
- INDUCTION:
During the induction, 3 pairs of sites per animals in the test group were injected with following materials:
5% palm oil in propylene glycol
5% palm oil in 50% aqueous Freund's Complete Adjuvant
50% Freund's Complete Adjuvant
Each material (0.5 mL) was injected intradermally.
In the booster phase, initiated 1 wk after induction, an occlusive dressing pad containing full strength palm oil (0.5 mL) was applied on the induction injection sites on each animal in the test group.
CHALLENGE:
2 wks after the booster phase, animals in first and second test groups were challenged with 0.5 mL 5% palm oil. Patches were applied to previously untreated sites and remained in place for 24 h. Reactions were observed 24 and 48 h after patch removal.
SCORING:
Following scale was used during the observation of skin sensitization:
0 (no evidence of any effects) to 4 (severe, deep red erythema with vesiculation or weeping with or without edema). - Challenge controls:
- The three pairs of sites on each control animal were injected intradermally with undiluted propylene glycol, 1:1 propylene glycol: 50% aqueous Freund's Complete Adjuvant, 50% aqueous Freund's Complete Adjuvant respectively, during induction. 1 wk after induction, a full strength petrolatum (booster) was applied according to the same procedure as in the test group.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- No details given
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No details given
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- No details given
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No details given
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the test conditions, 5% of the substance was found to be non-sensitizing to guinea pigs.
- Executive summary:
A study was conducted to determine the skin sensitization potential of the constituent ‘glycerides, C16 -18 and C18 -unsatd.’ (as palm oil) according to the Magnusson-Kligman maximization test, using three groups of 10 female guinea pigs of the Hartley strain. In the induction phase, the test group was injected with: 5% substance in propylene glycol, 5% substance in 50% aqueous Freund's Complete Adjuvant and 50% Freund's Complete Adjuvant. In the booster phase, the undiluted substance (0.5 mL) was applied occlusively. Two of the groups served as controls. All the groups were challenged with 0.5 mL of 5% substance. Reactions were observed 24 and 48 h after patch removal. No reactions were observed in any of the tested group. Under the test conditions, 5% substance was found to be non-sensitizing to guinea pigs (CTFA, 1978).
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