Fatty acids, C18-(unsaturated) dimers and their monoesters and diesters with 2-ethylhexanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-10-04 to 2011-12-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD guideline No. 437 in a GLP certified testing facility.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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

Test material form:

other: liquid

Details on test material:

Name: 400160
Batch no.: KL-11-038
Appearance: yellow, clear viscous liquid
Composition: UVCB, 2-Ethylhexyl esters of dimerised fatty acids, C18-unsaturated
Purity: 100% (GPC)
Production date: 24 March 2011
Expiry date: 24 March 2016
Storage: room temperature (20 ± 5 °C)

Test system

Vehicle:

other: olive oil

Amount / concentration applied:

750 µL of a 10% (w/v) test item solution in olive oil

Duration of treatment / exposure:

10 min at 32 °C

Details on study design:

For the BCOP test withBYK-400160 bovine corneas from freshly slaughtered cattle aged 12 to 60 months were used. The dissected corneas were transferred to a cornea holder and incubated with complete minimum essential medium (cMEM) at 32 ± 1°C for 1 h. After the initial incubation, the medium was changed and the baseline opacity was determined.
The test item is a surface-active liquid. It was tested diluted at a concentration of 10 % in olive oil. The solution was freshly prepared on the day of the assay. Olive oil was tested non-corrosive in previous tests. According to the guideline, the "closed chamber method" for surface-active substances was performed.
For each treatment group (negative control, positive control, solvent control, test itemsolution) three replicates were used and 750 µL of the respective solution was applied by pipetting through the refill hole in the holder on the cornea.
The exposition time on the corneas was 10 min at 32 °C. After thorough rinsing with cMEM a post-incubation time of 2 h at 32 °C followed. Then the opacity value of each cornea was determined and the permeability with sodium fluorescein was measured.
Opacity of the corneas is measured at 570 nm, using a spectral photometer.
Permeability is determined by the amount of sodium fluorescein dye that penetrates all corneal cell layers. The fluorescein permeability values are measured as optical density at 490 nm using a spectral photometer.

Results and discussion

In vivo

Results

Irritation parameter:

other: in vitro irritancy score

Basis:

mean

Score:

0.68

Max. score:

1.16

Remarks on result:

other: non-irritant

Other effects:

No other effects were observed.

Any other information on results incl. tables

Calculated IVIS

The calculated IVIS for each replicate and the corresponding means are presented in the following table:

Table 1: IVIS

Test Group	IVIS	Mean IVIS	Relative Standard Deviation IVIS
Negative Control 0.9 % NaCl	1.0860	0.8110	33.2%
	0.7972
	0.5487
Positive Control 10 % NaOH	191.8111	166.6690	12.8%
	156.8862
	151.9153
Solvent Control (olive oil )	0.7650	1.4140	40.7
	1.8602
	1.6182
400160	0.2008	0.6790	70.6%
	0.6758
	1.1599

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It can be stated that in this study and under the experimental conditions reported, 400160 possesses no eye irritation potential.

Executive summary:

The BCOP test was performed to assess the corneal irritation and damage potential of 400160 by quantitative measurements of changes in opacity and permeability in a bovine cornea. The test was performed according to OECD 437 and under GLP compliance. The test item solution in olive oil (10% w/v) was brought onto the cornea of a bovine eye which previously had been incubated with cMEM ( = complete Minimum essential medium) without Phenol red at 32±1°C for 1 h and whose opacity had been determined. The test item was incubated on the cornea for 10 min at 32±1°C. After removal of the test item solution, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control, olive oil was used as solvent control. The negative control and the solvent control showed no irritating effect on the corneas.10% sodium hydroxide solution was used as positive control. The positive control induced severe irritation on the cornea, mean IVIS was 166.67. The negative control showed no irritation, mean IVIS was 0.81. For the test item solution, a mean IVIS of 0.6790 was calculated, corresponding to a classification as no eye irritant.