Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride

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:

2009

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

Test material information

1

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

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.