Benzyl 2-methoxy-4-prop-1-enylphenyl ether

Eye irritation

Administrative data

Endpoint:

eye 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:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl 2-methoxy-4-prop-1-enylphenyl ether

EC Number:

204-370-6

EC Name:

Benzyl 2-methoxy-4-prop-1-enylphenyl ether

Cas Number:

120-11-6

Molecular formula:

C17H18O2

IUPAC Name:

benzyl 2-methoxy-4-prop-1-enylphenyl ether

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Approximately 50 mg of solid test item are evenly applied over the 0.6 cm2 of the tissue surface (approximately 83.3 mg/cm2 application).

Duration of treatment / exposure:

Tissues treated with solid test items and with control substances tested concurrently to solid test items are incubated for 6 ± 0.25 hours at standard culture conditions.

Duration of post- treatment incubation (in vitro):

At the end of the exposure period, the test item and control substances should be carefully removed from the tissue surface by extensive rinsing with Ca2+/Mg2+-free DPBS at room temperature. This rinsing step is followed by a 25 ± 2 minutes post-exposure immersion in fresh medium at room temperature and an 18 ± 0.25 hours post-exposure incubation in fresh medium at standard culture conditions, prior to performing the MTT assay.

Number of animals or in vitro replicates:

Two tissue replicates are used for each test item and each control substance.

Details on study design:

37°C, 5% CO2, 95% humidity (standard culture conditions)

Results and discussion

In vitro

Results

Irritation parameter:

other: tissue viability percent

Value:

154.12

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item BENZYL ISO EUGENOL does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category.

Executive summary:

The aim of the study was to evaluate the eye hazard potential of the test item BENZYL ISO EUGENOL after topical administration on in vitro reconstructed human cornea-like epithelium tissues (EpiOcularTM tissue model).

The test item BENZYL ISO EUGENOL was applied, as supplied, at the dose of 50 mg to 2 DPBS pre-treated RhCE (EpiOcularTM tissue model) during 6 hours at 37°C, 5% CO2, 95% humidity (standard culture conditions). The exposure period was followed by extensive rinsing with DPBS at room temperature, a 25 minutes post-exposure immersion period at room temperature and 18 hours and 00 minute post-exposure incubation at standard culture conditions. The tissue viability was measured by performing an MTT assay. The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 492 adopted 09 October 2017.

The mean percent tissue viability of the RhCE replicates treated with the test item BENZYL ISO EUGENOL was 154.12% (considered as 100%), versus 44.64% in the positive control (Methyl acetate).

In conclusion, under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item BENZYL ISO EUGENOL does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category.