4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone

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:

2016

Report date:

2016

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone

EC Number:

252-961-2

EC Name:

4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone

Cas Number:

36306-87-3

Molecular formula:

C14H24O2

IUPAC Name:

4-(1-ethoxyethenyl)-3,3,5,5-tetramethylcyclohexan-1-one

impurity 1

Reference substance name:

(3E,6E)-8-ethoxy-4,6,8-trimethylnona-3,6-dien-2-one

Molecular formula:

C14H24O2

IUPAC Name:

(3E,6E)-8-ethoxy-4,6,8-trimethylnona-3,6-dien-2-one

impurity 2

Reference substance name:

(E)-6-ethoxy-4,6,8-trimethylnona-3,7-dien-2-one

IUPAC Name:

(E)-6-ethoxy-4,6,8-trimethylnona-3,7-dien-2-one

impurity 3

Reference substance name:

(3E,6Z)-8-ethoxy-4,6,8-trimethylnona-3,6-dien-2-one

IUPAC Name:

(3E,6Z)-8-ethoxy-4,6,8-trimethylnona-3,6-dien-2-one

impurity 4

Reference substance name:

1,3-diethoxy-5,7,7-trimethylbicyclo[3.3.1]non-2-ene

IUPAC Name:

1,3-diethoxy-5,7,7-trimethylbicyclo[3.3.1]non-2-ene

impurity 5

Reference substance name:

3,5-diethoxy-1,7,7-trimethylbicyclo[3.3.1]non-2-ene

IUPAC Name:

3,5-diethoxy-1,7,7-trimethylbicyclo[3.3.1]non-2-ene

Test material form:

liquid

Specific details on test material used for the study:

Identification: Kephalis
Appearance: Pale yellow liquid
Batch: PE00134258
Purity/Composition: See Certificate of Analysis
Test item storage: At room temperature protected from light
Stable under storage conditions until: 08 July 2016 (expiry date)

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

Test System: Bovine eyes were used as soon as possible after slaughter.
Rationale: In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing (1-6). As a consequence a validated and accepted in vitro test for eye irritation should be performed before in vivo tests are conducted. One of the proposed validated in vitro eye irritation tests is the Bovine Corneal Opacity and Permeability (BCOP) test.
Source: 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.
Transport: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

1.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

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 35 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.
Kephalis did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.1 after 10 minutes of treatment.
Since Kephalis 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:

Evaluation of the eye hazard potential of Kephalis 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 Kephalis was tested through topical application for 10 minutes.
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 35 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.
Kephalis did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.1 after 10 minutes of treatment.
Since Kephalis induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.