Registration Dossier

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.