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EC number: 215-664-9 | CAS number: 1338-41-6
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992-09-28 until 1992-10-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given (analytical purity of test substance not specified, only 30% test substance evaluated, repeated application).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- Six emulsifiers were tested for their irritancy potential in a test panel of 25 healthy volunteer subjects in a repeat insult patch test.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sorbitan stearate
- EC Number:
- 215-664-9
- EC Name:
- Sorbitan stearate
- Cas Number:
- 1338-41-6
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- 1,4-anhydro-6-O-stearoyl-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): sorbitan stearate
Constituent 1
Method
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- The test substance was applied in a test panel of 25 normal healthy volunteer subjects (24 women, 1 men). The mean age was 44, ranging from 23 to 65. The study design was that of a repeat insult patch test consisting of six applications over a 15 day period under occlusive conditions. All subjects had been given a medical examination including blood pressure reading, pulse rate determination, medical history and full examination of the skin before joining the test panel and each subjects medical history was updated and recorded immediately prior to participation in the study. The nature of the study was explained to the subjects and they were informed that they were able to withdraw the study at any stage without obligation and without being required to state a reason. No subject had taken part in a study involving the test site during the previous 20 weeks and had not taken part in any study involving any other part of the back during the previous 8 weeks. Each subject received approximately 0.1 g of the respective six test materials (formulated in 30 % w/w in olive oil), among these the test substance, on the designated test sites on the back under occlusive conditions using 12 mm aluminium Finn chambers on Scanpor tape. Re-applications were made to the same test sites. At each assessment time the sites were graded using an arbitrary 8 scale, as follows: 0 = no reaction, 1 = slight, patchy erythema, 2 = moderate uniform erythema, 3 = strong erythema, 4 = strong erythema, spreading outside site of application, 5 = strong erythema, spreading outside site of application with either swelling or vesiculation, 6 = severe reaction with erosion. Re-applications were not made to any site which showed a reaction at any time that was graded as 2 (moderate erythema) or more.
Results and discussion
- Results:
- All subjects attended on all occasions and were considered to have completed the study. There were no grade 1 or grade 2 or higher reactions recorded during the 15 day application period. Therefore, the test substance was considered as non-irritant und the conditions of the test.
Applicant's summary and conclusion
- Conclusions:
- Repeated application of the test substance to human skin induced no irritating effects.
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