Distillate of aerobic enzymatic oxidation products of patchouli oil alpha-guaiene rich fraction

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Distillate of aerobic enzymatic oxidation products of patchouli oil alpha-guaiene rich fraction

EC Number:

700-880-2

IUPAC Name:

Distillate of aerobic enzymatic oxidation products of patchouli oil alpha-guaiene rich fraction

Test system

Amount / concentration applied:

10 microL of the undiluted test item were applied to each triplicate EPISKIN (Skinethic) tissues

Duration of treatment / exposure:

The skin equivalents were exposed to the test item for 15 minutes. After completion of the treatment the test item was rinsed off and the skin equivalents were incubated for further 42 hours.

Details on study design:

10 microL of the undiluted test item were applied to each triplicate EPISKIN (Skinethic) tissues. The test item was rinsed off skin equivalents after 15 minutes treatment. After further 42 hours incubation the tissues were treated with the MTT solution for 3 hours following approximately 70 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at a wavelenght of 570nm.

Results and discussion

In vivo

Irritant / corrosive response data:

After treatment with the test item Akigalawood the relative absorbance values were decreased to 14.2%.é This value is well below the threshold for irritancy of <= 50%. Therefore, the test item is considered to possess an irritant potential.

Any other information on results incl. tables

In vitro test

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item akigalawood is irritating to skin.

Executive summary:

This in vitro study was performed to assess the irritation potential of Akigalawood by means of the Human Skin Model Test.

Three tissues of the human skin model EpiSkin were treated with the test item, the negative or the positive control for 15 minutes.

10 microL of the test item were applied to each tissue, spread to match the tissue size.

The test item and the positive and negative controls were washed off the skin tissue after 15 minutes treatment. After further incubation for about 42 hours the tissues were treated with the MTT solution for 3 hours following approximately 70 hours extraction of the colorant from cells.

The amount of extracted colorant was determined photometrically at 570 nm.

10microL of either the negative control (deoinised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue.

After treatment with trhe negative control the absorbance values were well within the required acceptability criterion of mean OD 0.6 until 1.5 for the 15 minutes treatment interval thus showing the quality of the tissues.

treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 13.7% thus ensuring the validity of the test system.

The standard deviations between the % variabilities of the test item, the positive and negative controls were below 4% (threshold for irritancy of <= 50%. Therefore, the test item is considered to possess an irritant potential.