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EC number: 272-211-8 | CAS number: 68783-88-0 Complex combination obtained by steam distillation of soybean oil 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- 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:
- other: The study is well documented, meets generally accepted scientific principles
- 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:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A study was conducted to evaluate the allergenic potential of ingestion of soybean oil in soybean-sensitive individuals. Seven soybean sensitive patients were enrolled in a double-blind cross-over study. On four separate days, patients were challenged with the individual soybean oils and olive oil in random sequence. At 30 min intervals, under constant observation, patients ingested 2, 5 and 8 mL of one of the soybean oils or olive oil contained in 1 mL capsules.
- GLP compliance:
- not specified
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.
- Reference substance name:
- 6701-30-8
- IUPAC Name:
- 6701-30-8
- Details on test material:
- - Name of test material (as cited in study report): Partially hydrogenated (CAS N° 8016-70-4, EC N° 232-410-2), unhydrogenated (CAS N° 8001-22-7, EC N° 232-274-4) and cold-pressed soybean oils; under the SDA nomenclature, the name of these substances is ‘Glycerides, C16-18 and C18-unsatd.’
- Storage condition of test material: Individual oils were placed in separate gelatin capsules (1 ml per capsule), were packaged in coded plastic bags so that neither of the patient nor the physician would know which material was being administrated, and were frozen.
Constituent 1
Constituent 2
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- 7 patients (3 males and 4 females) and with a history of an immediate hypersensitivity reaction after ingestion of soybeans were recruited from the allergy clinics at the University of Wisconsin, Madison.
- Clinical history:
- Clinical summary of patients
No Age Sex Atopic history* Age Last exposure Reaction after Other legume sensitivity***
on set (in years) ingestion**
1 32 M - 8 3 RD, U GB, L, P, PN
2 63 F - 56 2 AE, LE, W -
3 18 F A, AR, E Infancy 6 AP, LE, U, W LB, P. PN
4 21 M A 8 3 AE, U, W GB, P, PN
5 50 M HS 30 <1 AE, U.W KB, L
6 38 F A, AR Infancy 10 R, U, W LB, KB, PN
7 21 F A, AR 20 <1 RD, W PN
*Atopic disease: A = asthma: AR = allergic rhinitis; E = eczema; HS = Hymenoptera sensitivity.
**Reaction: AE = angioedema; AP = abdominal pain; LE = laryngeal edema: R = rhinitis; RD = respiratory distress: U = urticaria:
W = wheezing.
***Legumes: GB = garbanzo bean; KB = kidney bean: L = lentil; LB = lima bean; P = pea; PN = peanut nut. - Controls:
- Olive oil
- Route of administration:
- oral
- Details on study design:
- Seven soybean sensitive patients were enrolled in a double-blind cross-over study. All patients had elevated levels of serum IgE antibodies to the crude soybean extract; binding values ranged from 2.3 to 28.1 times that of a negative control serum. Before the oral challenges, all the patients demonstratednegative puncture skin tests to three commercially available soybean oils and olive oil (control). On four separate days, patients were challenged with the individual soybean oils and olive oil in random sequence. At 30 min intervals, under constant observation, patients ingested 2, 5 and 8 mL of one of the soybean oils or olive oil contained in 1 mL capsules.
Results and discussion
- Results of examinations:
- No untoward reactions were observed with either the commercially available soybean oils or olive oil.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- The test substance ingestion does not appear to pose any risk of allergenicity in soybean-sensitive individuals.
- Executive summary:
A study was conducted to evaluate the allergenic potential of ingestion of ‘glycerides, C16-18 and C18-unsatd.’ (as soybean oil) in soybean-sensitive individuals.
Seven soybean sensitive patients were enrolled in a double-blind cross-over study. All patients had elevated levels of serum IgE antibodies to the crude soybean extract. Before the oral challenges, all the patients demonstrated negative puncture skin tests to three commercially available the test substance and olive oil (control). On four separate days, patients were challenged with the individual test substances and olive oil in random sequence. At 30 min intervals, under constant observation, patients ingested 2, 5 and 8 mL of one of the test substance or olive oil contained in 1 mL capsules.
No untoward reactions were observed with either the test substance or olive oil.
The test substance ingestion does not appear to pose any risk of allergenicity in soybean-sensitive individuals.
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