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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- other: Read-Across approach
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Read-Across approach
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: BIO-HC internal procedures
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: In vitro assessment of skin irritating potential
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
In vitro test system
- Details on the study design:
- The study was performed on human reconstituted epidermis EPISKIN samples of 1.07 cm².
The tissues were incubated for 4-5 hours in EPISKIN maintenace medium.
53.5 mg of the test material were applied on the epidermis previously moistened with distilled water during 15 minutes.
Viability of epidermis was assessed by a MTT test.
Results and discussion
In vitro / in chemico
Results
- Key result
- Run / experiment:
- other: Viability of epidermis by MTT test
- Parameter:
- other: Tissue viability
- Value:
- 50
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The tissue viability > 50%
Applicant's summary and conclusion
- Interpretation of results:
- other: PALMITOYL GRAPE SEED EXTRACT is not a skin sensitizer
- Conclusions:
- According to the final report for public distribution, « Safety Assessment of Vitis Vinifera (Grape)-Derived Ingredients as Used in Cosmetics », published the 5th of october 2012 by the expert panel members of the Cosmetic Ingredient Review (USA).
The Expert Panel assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients are most frequently reported to function in cosmetics as skin conditioning agents. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients; others are compounds that have been discussed in previous CIR safety assessments.
Most of the irritation and sensitization testing performed on the Vitis vinifera-derived ingredients included in this report demonstrated that these ingredients are not dermal irritants or sensitizers, with the exception of one 4-h semi-occlusive study of Vitis
Vinifera (Grape) Seed Extract that reported moderate irritation using rabbits when the test substance was applied neat.
Because all the other irritation and sensitization tests were negative, including a human study using up to 10% Vitis Vinifera (Grape) Fruit Extract in a product, the CIR Expert Panel was of the opinion that the one study was an outlier and that the weight of evidence supports the view that these ingredients are not irritants or sensitizers.
Our substance PALMITOYL GRAPE SEED EXTRACT is a grape seed extract of Vitis vinifera L. (Vitaceae), acylated with hexadecanoyl chloride.
The manufacturing process involves two steps : preparation of procyanidin oligomers extract from grape seed and its acylation with hexadecanoyl chloride (palmitoyl chloride).
The extraction/preparation of Vitis Vinifera (Grape) Seed Extract described in this report is similar to the manufacturing process of our substance PALMITOYL GRAPE SEED EXTRACT.
Moreover, an in-vitro assessment of skin irritating potential, based on a « Reconstituted Human Epidermis » model, conducted on our subtance PALMITOYL GRAPE SEED EXTRACT, (report IC-CHEM 09.508, done by the research laboratory BIO-HC), concluded that our substance must be classified as not irritant for skin.
Thus the content and the conclusion of this report is reliable and robust to demonstrate that the substance PALMITOYL GRAPE SEED EXTRACT is not a skin sensitizer. - Executive summary:
Refer to attached documents and study report.
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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