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Diss Factsheets
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EC number: 939-179-3 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-12-05 to 2009-02-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octanoic acid, esters with anhydrosorbitol and dianhydrosorbitol
- EC Number:
- 939-179-3
- Molecular formula:
- not applicable
- IUPAC Name:
- Octanoic acid, esters with anhydrosorbitol and dianhydrosorbitol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: approximately 100 cm² (10 cm x 10 cm)
- Type of wrap if used: The dressing was wrapped around the abdomen and anchored with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure, the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.
SCORING SYSTEM:
Data are summarized in tabular form, showing the irritation scores according to Commission Regulation (EC) No 440/2008 of 30 May 2008 for erythema and oedema for each individual animal at all observation intervals after patch removal, any lesions, a description of the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24hours
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0.67
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0
- Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining produced by the test item of the treated skin was observed. No alterations of the treated skin were observed and no corrosive effects were evident on the skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Sorbitan caprylate is considered to be “not irritating” to rabbit skin.
- Executive summary:
The primary skin irritation potential of sorbitan caprylate was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7 days after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00, 0.67 and 1.00, respectively, and the mean oedema score was 0.00 for all animals.
The application of sorbitan caprylate to the skin resulted in mild signs of irritation (erythema). These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the skin. sorbitan caprylate is considered to be “not irritating” to rabbit skin.
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