Oxacycloheptadecan-2-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2016

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oxacycloheptadecan-2-one

EC Number:

203-662-0

EC Name:

Oxacycloheptadecan-2-one

Cas Number:

109-29-5

Molecular formula:

C16H30O2

IUPAC Name:

oxacycloheptadecan-2-one

Test material form:

solid

Specific details on test material used for the study:

The test item was equilibrated to 38.0 °C for 20 minutes.

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 750 ul per cornea

NEGATIVE CONTROL
- Amount applied: 750 µl of physiological saline per cornea

POSITIVE CONTROL
Amount applied: 750 µl per cornea

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

3

Details on study design:

TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing: yes (with MEM with phenol red (Eagle’s Minimum Essential Medium, Invitrogen Corporation) and thereafter with cMEM)
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- After exposure the cornea was thoroughly rinsed to remove the test substance followed by incubation for 120 ± 10 minutes in cMEM. Then, corneas were incubated in sodium-fluorescein solution for 90 ± 5 minutes (both incubations at 32 ± 1°C).

- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).

TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces an IVIS > 55 is defined as a corrosive or severe irritan (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≥ 55, no prediction on irritant potency can be made.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Remarks:

mean of 3

Run / experiment:

Single run

Value:

-0.7

Negative controls validity:

valid

Remarks:

-0.8

Positive controls validity:

valid

Remarks:

61.8

Other effects / acceptance of results:

The individual in vitro irritancy scores for the negative controls ranged from -1.3 to -0.4. One of the negative control eyes was excluded since it was slightly translucent resulting in an opacity value which was outside the normal range. Since the other two eyes met the criteria and the test item results were not influenced by this exclusion, this was considered not to affect the study outcome. The individual positive control in vitro irritancy scores ranged from 53 to 73 for Ethanol. The corneas treated with the positive control item were turbid after the 10 minutes of treatment. The corneas treated with Oxacycloheptadecan-2-one showed opacity values ranging from -0.9 to 0.0 and permeability values ranging from -0.014 to -0.007. The corneas were clear after the 10 minutes of treatment with the test substance. The in vitro irritancy scores ranged from -1.1 to -0.1 after 10 minutes of treatment with Oxacycloheptadecan-2-one.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of a Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD gudieline and GLP principles, it is concluded that Oxacycloheptadecan-2-one is not irritant or corrosive for the eye.

Executive summary:

A Bovine Corneal Opacity and Permeability test (BCOP) was performed with oxacycloheptadecan-2-one according to OECD guideline 437 and GLP principles. Oxacycloheptadecan-2-one was applied undiluted (750 ul/ cornea, n=3). The mean in vitro irritancy score of the positive control (ethanol) was 61.8, and the mean in vitro irritancy score of the negative control (physiological saline) was -0.8. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Oxacycloheptadecan-2-one did not induce ocular irritation through opacity or permeability, resulting in a mean in vitro irritancy score of -0.7 after 10 minutes of treatment. Since oxacycloheptadecan-2-one induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.