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Diss Factsheets
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EC number: 947-474-3 | CAS number: -
- 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
- Study period:
- 2004-06-30 to 2004-08-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study report which meets basic scientific principles, guideline study, no GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline E6
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids
- EC Number:
- 947-474-3
- Molecular formula:
- not available
- IUPAC Name:
- Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids
- Test material form:
- solid: pellets
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 112 (male and females) were selected. 104 subjects remained in the study and completed it.
- Sex: Male and female
- Age: From 16 to 78 years. - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: Repeated Insult Patch test
ADMINISTRATION
- Type of application: occlusive
- Treatment area: Upper back between the scapulae served as the treatment area.
- Description of patch: 0.2 mL of test material, or an amount sufficient to cover the contact surface, was applied to the 3/4" x 3/4" absorbent pad portion of an adhesive dressing.
- Vehicle: Cetiol CC
- Removal of test substance: Participants were instructed to remove all induction patches at home, 24 hours after application.
- Concentrations: The test material was prepared as a 50 % dilution, using the supplied diluent, Cetiol CC.
- Induction phase: Patches were applied 3 times per week for a total of nine applications.
- Challenge phase: Approximately two weeks after final Induction patch application, a Challenge patch was applied to a virgin test site adjacent to the original Induction patch site.
EXAMINATIONS
- Grading/Scoring system: 0 = No visible skin reaction
+ = Barely perceptible or spotty erythema
1 = Mild erythema covering most of the test site
2 = Moderate erythema, possible presence of mild edema
3 = Marked erythema, possible edema
4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 103
- Number of subjects with equivocal reactions: 1
- Number of subjects with irritating reactions: 1
Conclusion
With one exception, observation remained negative. Under the conditions of this study, the test material did not indicate a clinically significant potential for dermal irritation or induced allergic contact sensitization.
Applicant's summary and conclusion
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.
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