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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: BIO-HC Company internal procedures
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:
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
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:
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:

Results and discussion

In vitro

Irritation / corrosion parameter:
% tissue viability
ca. 99
Negative controls validity:
Viability: 100%
Positive controls validity:
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
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%


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.