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Diss Factsheets
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EC number: 921-548-5 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: NEUTRAL RED RELEASE METHOD
- Principles of method if other than guideline:
- PREDISAFE is a cell kit based on the use of a rabbit fibroblastic tell line (SIRC line)6 using cytotoxicity as endpoint. The test product is applied, for a short time, on the confluent monolayer of cells already preloaded with neutral red. Then, the variation in the viability between control cells and treated tells is measured according to the neutral red release (NRR) assay described by Borenfreund et al. (1984)
Different concentrations of the test product are used in the assay in order to determine the
amount inducing a 50% réduction in the NRR (IC50, inhibition concentration 50).
An in vitro/in vivo correlation matrix between the IC50 determined in the PREDISAFE assay
and the Draize irritation data, allows the assessment of the ocular tolerance of the test product (Guyomard et al., 1994) - GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydrogenated Stearyl Olive Oil Esters
- Molecular formula:
- not available
- IUPAC Name:
- Hydrogenated Stearyl Olive Oil Esters
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Tested: at the use concentration of 100% and at 3 lowers (10%, 30% and 50%) prepared from the use concentration (all dilutions were prepared in lipophilic solvent).
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- Confluent monolayer fibroblast cells isolated from rabbit cornea, and seeded in 24-well plates. Cells were receipt in an appropriate culture medium (called
shipping medium) to limit cellular metabolism during shipping.
Test system
- Vehicle:
- other: paraffin oil
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 4 concentrations were tested : 100% and at 3 lowers (10%, 30% and 50%)
- Duration of treatment / exposure:
- 1 minute
- Number of animals or in vitro replicates:
- 24-well plate
- Details on study design:
- Four hundred microlitres of fresh culture medium containing neutral red was added into each well
Fibroblasts were then incubated for 3 hours at 37°C in absence of CO2.
Following neutral red incorporation, cells were rinsed and test product was applied for 1 minute precisely.
In parallel, quality controls (the three reference products) and control (cells treated with the solvent hydrophilic and/or lipophilic) were performed.
After the short contact period, test product was removed and the cells were washed several times with the rinsing medium.
Five hundred microlitres of the lysis solution were added into each well and allowed shaking for few minutes.
After making the blank correction with the lysis solution, optical density was measured at 540 mn using a microplate reader.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Predisafe IC50
- Remarks:
- The concentration of test product inducing a 50% reduction of neutral red release (IC50) was determined graphically from the dose-response curve.
- Value:
- >= 50
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
DRAIZE MAS |
CLASSIFICATION |
PREDISAFETMIC50 |
<15 |
Class I, slightly irritating |
>50% |
15 -30 |
Class II, moderately irritating |
25%-50% |
30 -50 |
Class III, irritation |
3 %-25% |
>50 |
Class IV, very irritating |
<3% |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Executive summary:
The test substance was slightly irritating for the eye.
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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