ethyl 2-acetyl-4-methyltridec-2-enoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 November 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

conducted under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

2013

Deviations:

yes

Remarks:

One of the negative control eyes was excluded since the final opacity value of 4.2 was slightly outside the historical data range. Since the other two eyes met the criteria and the test item results were not influenced, no affect on the study outcome.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ethyl 2-acetyl-4-methyltridec-2-enoate

EC Number:

816-455-0

Cas Number:

960253-23-0

Molecular formula:

C18H32O3

IUPAC Name:

ethyl 2-acetyl-4-methyltridec-2-enoate

Test material form:

liquid

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

The test item was applied as it is (750 μl) directly on top of the corneas

Duration of treatment / exposure:

Corneas were incubated in a horizontal position for 10+/- 1 minutes at 32 +/- 1°C

Duration of post- treatment incubation (in vitro):

Subsequently the corneas were incubated for 120 +/- 10 minutes at 32 +/- 1°C.

Number of animals or in vitro replicates:

Triplicate for each group (test item, negative and positive control)

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

10 minutes of treatment

Value:

-0.2

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 45 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
GR-86-6599 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.2 after 10 minutes of treatment. Since GR-86-6599 induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

GR-86-6599 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.2 after 10 minutes of treatment. Since GR-86-6599 induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.

Executive summary:

Evaluation of the eye hazard potential of GR-86-6599 using the Bovine Corneal Opacity and Permeability test (BCOP test).

This report describes the potency of chemicals to induce serious eye damage using isolated

bovine corneas. The eye damage of GR-86-6599 was tested through topical application for

10 minutes.

The study procedures described in this report were based on the most recent OECD guideline.

Batch 43 of GR-86-6599 was a yellow liquid with a purity of 96.5%. The test item was applied as it is (750 μl) directly on top of the corneas.

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 45 and

was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

GR-86-6599 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.2 after 10 minutes of treatment.

Since GR-86-6599 induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.