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Diss Factsheets
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EC number: 924-579-2 | 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
- Remarks:
- clinical data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: patch test
- Principles of method if other than guideline:
- The raw material was applied, once, to the skin under patch. It was tested concurrently with other 6 raw materials. The panel of volunteers was representatibve of a large population. The monocentric study was performed in open. The subject was used as own control.
The skin compatibility of the raw material was checked, after patch removal and visual examination of the experimental area by the investigator or the responsible technician.
The skin compatibility of the raw material, after application under normal conditions of used, was assessed by extrapolation of the results obtained under these specific experimental conditions.
The results were mainly expressed as descriptibve data and did not require a statistical treatment. If the test raw material - GLP compliance:
- not specified
Test material
- Reference substance name:
- hydrogenated decyl olive oil esters
- Molecular formula:
- not applicable
- IUPAC Name:
- hydrogenated decyl olive oil esters
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- other: Human
- Strain:
- other: Not Applicable
- Details on test animals or test system and environmental conditions:
- The number of volunteers whose data had to be exploitable at the end of the study was 10. 10 volunteers were included in the study.
The specific inclusion criteria, defined in the protocol, were the following ones:
-age : 18 to 70
-sex : male and female
-phototype (Fitzpatrick) : I to V
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Not Applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 160µL (approximately 160mg), kept in position by a non woven medical adhesive (surface : 400mm2)
- Duration of treatment / exposure:
- 48h +/-5 hours
- Observation period:
- The patch removal had to be performed by the investigator or the responsible technician.
One deviation from the protocol concerning the contact time was noticed by the investigator and is the following one : one volunteer (reference 10) kept the patch for 41 hours 30.
This deviation was judged without effect on the results of the study by the Investigator. - Number of animals:
- 10 humans volunteers
- Details on study design:
- The experimental area was the back.
The site of application of the raw material was chosen by the investigator or by the technician in charge of the study. Skin appearance was taken into account and the areas of friction with clothes were avoided.
Many other raw materials were tested concurrently, so the concerned raw material was applied by the investigator or the responsible technician, to one of the sites localized by a clockwise distribution, altering of one rank from a subject to another.
This examination had to be performed visually under standard "daylight" source, approximateiy 15 minutes (or more if some redness appeared after patch removal), after patch removal.
The expression of the results of the skin examination and questioning was that defined for this type of study in accordance with the corresponding procedure.
In case of reactivity :
— the main visible signs were noted, i.e.
Erythema, Oederna, Vesicle, Bulla, Papule, Scab, Dryness, Coloration, Soap effect.
The intensity of the erythema and oedema was assessed according ta an ordinal scale : slight, moderate, severe.
The appearance of the erythema was specified : diffuse, punctuated, peripheral (around the application site).
The importance of the number of vesicles and papules was assessed according_to an ordinal scale : 1 to 2 vesicles or papules, more than 2 vesicles or papules.
Bullae, scab, dryness, coloration and soap effect were described.
The importance of the dryness and coloration was assessed according to an ordinal scale : slight, moderate, severe.
— the main sensations of discomfort were described, i.e. : Heating, Stinging, Pruritus (itching).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Control time after |
Number of reactive |
Types of reaction |
Meandally irritation |
% of reactive |
T 15 minutes |
0 |
None |
0 |
0% |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Under the experimental conditions adopted, the raw material hydrogenated decyl olive oil esters diluted at 10% with Squalane, has a very good skin compatibility and is safe for human health when applied under normal or foreseeable conditions of use.
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