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Diss Factsheets
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EC number: 941-319-3 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- 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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: BIO-HC internal procedures
- Deviations:
- no
- Principles of method if other than guideline:
- The eye irritant potential of the test material is assessed by measurement of its cytotoxic effect on a 3-dimensional reconstituted human corneal epithelial model (HCE SkinEthic Model).
The test material is applied as supplied, topically to the tissues for 60 minutes. After a 16h post-treatment incubation, the viability of tissues is evaluated by a MTT test. The results of the MTT assay allows to classify the test material. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride
- EC Number:
- 941-319-3
- Molecular formula:
- Unknown (Substance of Unknown or Variable Composition)
- IUPAC Name:
- Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- Palmitoyl grape seed extract is the chemical name of BERKEMYOL PEPIN DE RAISIN (the trade name).
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The study is performed on the reconstituted human corneal epithelial model from SkinEthic laboratories (HCE model). This model consists of an epithelium derived from immortalized human corneal epithelial cells (HCE) cultured in a defined medium at the air-liquid interface.
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg of the test material
- Duration of treatment / exposure:
- 60 minutes
- Duration of post- treatment incubation (in vitro):
- 16 hours
- Number of animals or in vitro replicates:
- 0.5 cm² of the tissue surface
- Details on study design:
- Test material application:
Prior to the application of the test substance, epithelia are transferred into 24-well plates filled with SkinEthic maintenance medium.
30mg of the test material are topically applied on the 0.5cm² of the tissue surface. The treated tissues are incubated at room temperature for 60 minutes.
In parallel, 3 untreated tissues (nagative control) and 3 tissues treated with ethanol (positive control) are placed in cluster plates containing maintenance medium and incubated for 60 minutes.
Post treatment incubation:
After 60 minutes exposure with the test material, the treated tissues are rinsed thoroughly with PBS to remove all residual test material from the surface. After rinsing, the tissue units are incubated with new maintenace medium at 37°C in 5% CO2 humidified atmosphere for additional 16 hour post-treatment incubation period.
Tissue viability - MTT test:
At the end of the assay, tissues are transferred in a 24-wel culture dish containing MTT solution. After 3hr incubation at 37°C, the epithelia are transferred in a 24-wel culture dish containing acidified isopropanol. The plates are stored 2 hours at room temperature, under gentle shaking, protected from light. At the end of the extraction period, 3 x 200 µl aliquots of extracts are transferred to a 96-well flat bottom plate before measuring optical density (O.D.) at 570 nm with isopropanol as a blank, using a microtiter plate reader.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Tissue viability
- Vehicle controls validity:
- valid
- Remarks:
- Viability : 106%
- Negative controls validity:
- valid
- Remarks:
- Viability : 100%
- Positive controls validity:
- valid
- Remarks:
- Viability : 2%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The viability of 2% for the positive control validates the assay.
No deviation to the experimental protocol was reported and not any amendment was made on the protocol.
Applicant's summary and conclusion
- Interpretation of results:
- other: No significant cytotoxicity was recorded. The test material is not irritant
- Conclusions:
- No significant cyototoxic effect was observed in the experimental conditions described in attached study report.
The results of the MTT assay indicate: Tissue Viability > 50%. So the test material is not irritant to eyes - Executive summary:
The assay was performed on reconstituted human corneal epithelia SkinEthic (RHC / S /5 batch 09 022D 0703) of 0.5 cm² surface.
30 mg of the test material as supplied were applied on the epithelia surface. Viability of epidermis was assessed by a MTT test.
Tissue viability results are summarized in the following table:
Negative control (PBS) Positive control Test article Tissue viability 100% 2% 106% No significant cyototoxicity was recorded. Taking into account the results obtained (viability more than 50%) the test article can be classed as Not irritant.
Under the same experimental conditions, ethanol induced an important cyototoxic effect (Viability = 2%). This result (viability<50%) validates the assay.
No deviation to the experimental protocol was reported.
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