Octadecyl acrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-05-31 to 2012-03-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Version / remarks:

September 07, 2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Version / remarks:

Commission Regulation (EU) No. 1152/2010 of 8 December 2010

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

BASF SE

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, C16-18-alkyl esters

EC Number:

292-060-1

EC Name:

2-Propenoic acid, C16-18-alkyl esters

Cas Number:

90530-21-5

IUPAC Name:

2-Propenoic acid, C16-18-alkyl esters

Test material form:

other: solid

Test animals / tissue source

Species:

other: in vitro (bovine eyes)

Strain:

other: in vitro

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Isolated bovine cornea: The test system (target tissue) is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle (age of the animals: minimum 12 months, maximum 60 months).
- Source: Schlachthof Bensheim, Am Schlachthof 7-9, 64625 Bensheim
- Age at study initiation: minimum 12 months, maximum 60 months

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 750 µL undiluted test substance (after heating at ca. 30 °C)

Duration of treatment / exposure:

10 min

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

3 corneas

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

mean

Value:

1.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

other: permeability value

Run / experiment:

mean

Value:

0.002

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

in vitro irritation score

Run / experiment:

mean

Value:

1.2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Test Substance	Mean Opacity Value	Mean Permeability Value	In Vitro Irritation Score
12/0073-1	1.1	0.002	1.2
NC	2.8	-0.010	2.6
PC	121.7	3.204	169.7

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

No predicition can be made for eye irritation according to GHS criteria.

Conclusions:

Based on the observed results and applying the evaluation criteria it was concluded, that the test substance does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.
The test method according to the regulatory accepted protocol at the time of reporting does not allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed.

Executive summary:

The potential of the test substance to cause serious damage to the eyes was assessed by a single topical application of 750 µL of the undiluted test substance to the epithelial surface of isolated bovine corneas.

Three corneas were treated with the test substance for 10 minutes followed by a 2 -hours post-incubation period.

Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance relative to the control corneas.

The BCOP test showed the following results:

Test substance	Mean Opacity Value	Mean Permeability Value	In Vitro Irritancy Score
Test item	1.1	0.002	1.2
NC	2.8	- 0.010	2.6
PC	121.7	3.204	169.7

Based on the observed results and applying the evaluation criteria it was concluded, that the test substance does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.

The test method according to the regulatory accepted protocol at the time of reporting does not allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed.