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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

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:

Each 0.75 mL of the undiluted test item were applied to three bovine corneas.

Duration of treatment / exposure:

The corneas were exposed to the undiluted test item for 10 minutes.

Details on study design:

Three corneas were exposed to each 0.75 mL of the neat item to 10 minutes. After the treatment the test item was rinsed off the corneas and they were incubated for further 2 hours. After the 2 hours incubation the corneas' opacity was determined. In a second step the permeability of the corneas was determined. In a second step the permeability of the corneas was determined photometrically after 90 minutes treatment with fluorescen solution.

Results and discussion

In vivo

Irritant / corrosive response data:

Relative to the negative control, the test item Akigalawood did not cause any opacity or permeability of the corneae. The calculated mean in vitro score was 0.00. In conclusion, according to the current study and under the experimental conditions reported, the test item Akigalawood is not corrosive to the eye (CLP/EPA/GHS).

Any other information on results incl. tables

In vitro test

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Remarks:

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, according to the CLP/EPA/GHS classification the test itema Akigalawood is not considered to be corrosive to the eye. According to the INVITTOX (UK) protocol No. 98 the test item is classified as non eye irritant.

Executive summary:

The test item was tested undiluted. The positive control 2 -Ethoxyethanol was tested neat. Saline was used as negative control item.

After a first opacity measurement of the fresh bovine coreneae (t0), the neat test item Akigalawood, the positive, and the negative controls were applied to the corneae and incubated for 10 minutes at 32 ± 1°C in complete medium. After the incuvbation phase the test item, the positive and the negative controls were each rinsed from the corneae. Further, the corneae were incubated for another 120 minutes at 32 ± 1°C in completed medium, and opacity was measured a second time ( t130).

After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of fluorescein after incubation in a horizontal position for 90 minutes at 32± 1°C.

With the negative control (saline) neither an increase of opacity and distinctive permeability of the corneae (mean in vitro score 69.29) corresponding to a classification as corrosive to the eye (CLP/EPA/GHS (classI)).

Relative to the negative control, the test item Akigalawood did not cause an increase of the corneal opacity and permeability. The calculated mean in vitro score was 0.00.