Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 215-355-9 | CAS number: 1323-42-8
- 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)
Some information in this page has been claimed confidential.
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:
- secondary source
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- case report
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Human Patch test
- Principles of method if other than guideline:
- Human volunteers are patched with test material, and the results in the skin are evaluated after 24-48 hours by a trained expert and reported.
- GLP compliance:
- not specified
Test material
- Test material form:
- solid
- Details on test material:
- As per the 2007 CIR Final Report on Ricinus communis, Hydrogenated Castor Oil consists primarily of glyceryl-tri-hydroxystearate (Nikitis and McEwen, 1990). The National Formulary (Committee of Revision of the United States Pharmacopeial Convention 2004b) has published the following requirements for Hydrogenated Castor Oil: free fatty acids (free fatty acids in 20 g require for neutralization not more than 11.0 ml of 0.1 N sodium hydroxide), heavy metals (0.001%), hydroxyl value (between 154 and 162), iodine value (not more than 5), and saponification value (between 176 and 182).
Constituent 1
- Specific details on test material used for the study:
- no data
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- Test subjects were three human patients who had occupational sensitivity to castor bean extract.
- Controls:
- Seven laboratory personnel
- Route of administration:
- dermal
- Details on study design:
- Lehrer et al. (1980) evaluated the sensitivity of three human subjects (with occupational hypersensitivity to castor allergens) to castor bean extract and four Castor Wax extracts (solvent = SLS, PBS, urea-NaCl, or Triton X-100). Seven normal laboratory personnel served as controls. The test substances were applied to the skin using both patch and prick tests. Only the castor bean extract and the SLS extract of Castor Wax were evaluated in the prick test; the four Castor Wax extracts were evaluated in the patch test.
In the prick test (to detect IgE-mediated hypersensitivity), a drop of allergen extract was applied to the skin. Following application to the skin, the underlying superficial layer of the skin was pricked with a 25-gauge needle. Reactions were scored 15 min after application of the allergen. A positive prick test reaction was defined as a wheal and flare reaction with edema >5 mm. Castor bean extract was tested at concentrations up to 1000 µg/ml and, SLS Castor Wax extract, at concentrations up to 22,000 µg/ml. Results from the prick test indicated no immediate skin reactivity to castor bean extract or the SLS Castor Wax extract.
In patch tests (to detect cell-mediated hypersensitivity), a semiocclusive patch containing either of the four Castor Wax extracts (concentration not stated) or paraffin (control) was applied to the skin for 24 and 48 h. Reactions were scored at 24 and 48 h post removal.
Results and discussion
- Results of examinations:
- The three patients were highly sensitive to castor allergen in the prick test (positive skin reaction to 1.0 or 0.1 µg/ml castor bean extract). The patients also had a positive skin reaction to the SLS Castor Wax extract, where the level of sensitivity was 100- to 100,000-fold less than that induced by castor bean extract. None of the seven normal subjects had a delayed reaction to any of the four Castor Wax extracts that were tested. Prick test results (normal subjects) indicated no immediate skin reactivity to castor bean extract or the SLS Castor Wax extract.
Because immediate hypersensitivity to Castor Wax was observed in the three patients who were sensitive to castor bean, additional tests (prick tests) were performed to determine whether Castor Wax solubilized in different organic solvents or an underarm deodorant stick containing Castor Wax would induce irritation and elicit a positive immediate hypersensitivity reaction in these three patients. Positive skin reactions to Castor Wax (in different solvents or in a deodorant stick) were not detected.
The four Castor Wax extracts and paraffin (control) were evaluated in patch tests for cell-mediated hypersensitivity. None of the three patients had a delayed reaction to any of the four Castor Wax extracts (test concentration not stated).
Applicant's summary and conclusion
- Conclusions:
- In three patients with documented occupational sensitivity to castor bean, all patients showed positive skin prick test reactions to 0.1 to 1.0 µg/ml castor allergen. In addition, there were positive skin prick tests to the SLS Castor Wax extract, but at a level of sensitivity 100- to 100,000-fold less than that induced by castor bean extract. There were no positive results reported for the patch tests in patients or in controls.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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