2-ethylhexyl 12-(acetoxy)octadecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 Mar 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2103

Report date:

2013

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

hydrogenation products of (esterification products of 2-ethylhexan-1-ol with (Estolide formation products of oleic acid and Fatty acids, C8-18 and C18-unsatd. (branched or linear))

IUPAC Name:

hydrogenation products of (esterification products of 2-ethylhexan-1-ol with (Estolide formation products of oleic acid and Fatty acids, C8-18 and C18-unsatd. (branched or linear))

Test material form:

liquid

Test animals / tissue source

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Not applicable as this is an in vitro study. However the bovine eyes were received from JW. Treuth & Sons, Inc. on 06 Mar 2013 and transported overnight to MB Research in Hank's Balanced Salt Solution with Pennstrep in a refrigerated container.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Liquids were tested undiluted. Following the pretest observations, the MEM solution was removed from the anterior chamber. A volume of 0.75 ml of the ethanol, MEM or liquid test article was applied to the epithelium of each of the three (3) positive controls, three (3) negative controls, or three (3) test articletreated corneas in a manner, which ensured the entire cornea was covered.

Duration of treatment / exposure:

10 minutes

Observation period (in vivo):

2 hours

Details on study design:

All holders and corneas were placed in a horizontal position (anterior side up) in the 32°C (± 1°C) incubator. After 10.:!:. 1 minute, the test article, ethanol or MEM solution in the controls were removed from the epithelium of the cornea and anterior chamber of the holder by washing with MEM solution containing phenol red. The anterior and posterior chambers of the holders were refilled with fresh MEM solution. Opacity measurements were made following the 10-minute exposure and MEM solution refill.

All corneas were incubated at 32°C (± 1°C) for an additional two hours at which time the MEM solution in the anterior and posterior chambers was removed and the holders refilled with fresh MEM solution. A measurement of opacity was taken with each treated cornea compared to the blank supplied with the OPKIT. This is the reading that was used in the final in-vitro calculations.

Immediately following the 2-hour opacity measurement, the MEM solution was removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium fluorescein solution (in Dulbecco's Phosphate Buffered Saline) for liquid test articles and corresponding controls. Each holder was returned to the 32°C (± 1°C) incubator in a horizontal position (anterior side up) ensuring contact of the fluorescein with the cornea.

After 90 minutes, the fluid from the posterior chamber was removed and the amount of dye, which passed through the cornea, was measured as the optical density at 490 nm by a plate reader or spectrophotometer.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Remarks:

Calculated in vitro score

Run / experiment:

Mean

Value:

1.43

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

Irritant / corrosive response data:
Test material - In vitro Score: 1.43
Negative Control (MEM) - In vitro score: 0.71
Positive control (ethanol) - In vitro score: 43.27

The corrected mean opacity score was 1.34. The corrected mean optical density (permeability) score was 0.006.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The in vitro score was calculated as 1.43. The substance is not irritating

Executive summary:

Objective: To determine the potential for ocular irritation using an alternative to the Draize methodology. This protocol is based on the methodology described in the OECD Guideline for the Testing of Chemicals #437, adopted September 7,2009.

Method Synopsis: Three corneas were dosed with 0.75 ml of CAS# 1365345-64-7 (SE7B Batch 2137-0). Opacity measurements and sodium fluorescein permeability were determined.

Summary: The corrected mean opacity score was 1.34. Controls were within normal limits. The corrected mean optical density (permeability) score was 0.006.

Conclusion: The in vitro score was calculated as 1.43.