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Diss Factsheets
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EC number: 205-471-8 | CAS number: 141-23-1
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Glyceryl Ricinoleate, Glyceryl Ricinoleate SE, Ricinoleic Acid, Potassium Ricinoleate, Sodium Ricinoleate, Zinc Ricinoleate, Cetyl Ricinoleate, Ethyl
- Author:
- Johnson Jr., W.
- Year:
- 2 007
- Bibliographic source:
- International Journal of Toxicology, 26 (Suppl. 3): 31–77, 2007
Materials and methods
- Type of sensitisation studied:
- skin
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Human clinical Maximization test
- Principles of method if other than guideline:
- Skin sensitisation study (Maximization HRIPT) in human volunteers
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethyl (R)-12-hydroxyoleate
- EC Number:
- 259-462-9
- EC Name:
- Ethyl (R)-12-hydroxyoleate
- Cas Number:
- 55066-53-0
- Molecular formula:
- C20H38O3
- IUPAC Name:
- ethyl (9Z,12R)-12-hydroxyoctadec-9-enoate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Remarks:
- informed consent likely obtained
- Subjects:
- 32 healthy male volunteers
- Route of administration:
- dermal
- Details on study design:
- Test sites of both forearms of the subjects were pretreated with a 5% aqueous sodium laural sufate (SLS) solution, under occlusive bandage, for 24 hours preceded the application of test substance. The test material (20% in petrolatum) was applied under occlusion to the same site of each subject, remaining in place 48-hour and appplication repeated at 2-day intervals for a total of 5 inductions. At the end of the 10-14 day rest period (non-treatment) period, new challenge sites (under occlusion) were treated with test substance. Prior to challenge, on the left forearm, the sites were retreated with SLS for 30 minutes preceeding application of the test substance; on the right forearm, no pretreatment with SLS took place. A fifth site (patch with petrolatum vehicle) served as a vehicle control.
Results and discussion
- Results of examinations:
- No significantly irritating or allergic reactions were observed.
Applicant's summary and conclusion
- Conclusions:
- In a clinical Maximization HRIP test in 32 human volunteers, the test substance was applied under occlusion to SLS-treated skin, over 5 48-hour induction periods. New skin sites were challenged (with and without SLS). No skin irritation or sensitisation was reported.
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