Hexanedioic acid, mixed benzyl and 2-(2-methoxyethoxy)ethyl diesters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19-22 April 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data is based on GLP compliant data accordingly to internationally recognised and EU guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of benzyl 2-(2-methoxyethoxy)ethyl adipate and bis[2-(2-methoxyethoxy)ethyl] adipate and dibenzyl adipate

EC Number:

940-202-4

Cas Number:

1175612-76-6

Molecular formula:

Cannot be assigned to the reaction mass

IUPAC Name:

Reaction mass of benzyl 2-(2-methoxyethoxy)ethyl adipate and bis[2-(2-methoxyethoxy)ethyl] adipate and dibenzyl adipate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for several seconds to prevent the loss of the test item.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after treatment.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Any other information on results incl. tables

The eyes were examined at 1, 24, 48 and 72 hours after the application.

 

Initial Pain Reaction (IPR) (score 1) was observed in two animals.

 

One hour after the application, conjunctival redness (score 1) was observed in two animals.

At 24 hours after treatment, fully recovery was noted.

At 48 hours after treatment, there were no clinical signs observed.

At 72 hours after treatment, there were no clinical signs observed.

 

As there were no clinical signs observed, the study was terminated after the 72 hour observation.

During the study, the control eye of all animals was symptom-free. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

chemosis :                  0.00, 0.00, 0.00

discharge :                 0.00, 0.00, 0.00

redness :                    0.00, 0.00, 0.00

cornea opacity :         0.00, 0.00, 0.00

iris :                           0.00, 0.00, 0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is not irritating to eyes

Executive summary:

The primary eye irritation of the neat substance has been assessed in the eyes of New Zealand white rabbits according to the OECD 405 test guideline. The substance initially caused cunjunctival redness of score 1 in two animals at 1 hour. No effects were observed at 24 hours or at any remaining observation point.