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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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 Company internal procedures
- Deviations:
- no
- Principles of method if other than guideline:
- The essay is based on the aplication of the product to be tested on the surface of reconstructed human epidermis for a definite period time. After a post-treatment incubation, the tissue viability is evaluated by a colorimetric MTT assay.
- 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).
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The essay is performed on reconstructed human epidermis model EPISKIN.
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours at 37°C in a 5% CO2 humidified atmosphere.
- Number of replicates:
- 12
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 99
- Negative controls validity:
- valid
- Remarks:
- Viability: 100%
- Positive controls validity:
- valid
- Remarks:
- Viability: 14%
- Other effects / acceptance of results:
- No significant cytotoxicity was recorded. Taking into account the results obtained (viability more than 50%)the test article can be classed as Not irritant.
Applicant's summary and conclusion
- Interpretation of results:
- other: The test item is not irritant for skin
- Conclusions:
- The skin irritating potential of BERKEMYOL PEPIN DE RAISIN was assessed by measurement of its cytotoxic effect on a 3-dimensional reconstituted haman epidermis model (EpiSkin TM Model). The test material was applied as supplied, topically to the epidermis units for 15 minutes. After 42h post-treatment incubation, the viability of tissues was evaluated by MTT test. No significant cytotoxic effect was observed in the experimental conditions described. The results of the MTT assay indicate : cell Viability > 50 %. So the test article is classified as NOT IRRITANT for skin.
- Executive summary:
The assay was performed on human reconstituted epidermis EPISKIN samples of 1.07 cm².
53.5mg of the test material as supplied were applied on the epidermis previously moistened with distilled water during 15 minutes.
Viability of epidermis was assessed by a MTT test. Results of tissue viability are summarised in the following table:
Nagative control (PBS) Positive control Test article Tissue viability 100% 14% 99%
No significant cytotoxicity was recorded.
Taking into account that the obtained viability is more than 50%, the test article can be classified as Not irritant.
Under the same experimental conditions, 5% SDS solution induced an important cytotoxic effect (viability = 14%). This result (viability < 30 %) validates the assay.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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