Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

skin sensitisation: in vitro
Type of information:
other: Read-Across approach
Adequacy of study:
weight of evidence
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Read-Across approach

Data source

Referenceopen allclose all

Reference Type:
study report
Report date:
Reference Type:
Report date:

Materials and methods

Test guideline
according to guideline
other: BIO-HC internal procedures
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:
Molecular formula:
Unknown (Substance of Unknown or Variable Composition)
Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride
Test material form:
solid: particulate/powder

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

Key result
Run / experiment:
other: Viability of epidermis by MTT test
other: Tissue viability
Vehicle controls validity:
Negative controls validity:
Positive controls validity:
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
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.