Nonanoic acid, esters with adipic acid and trimethylolpropane

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate

EC Number:

204-793-6

EC Name:

2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate

Cas Number:

126-57-8

Molecular formula:

C33H62O6

IUPAC Name:

2,2-bis[(nonanoyloxy)methyl]butyl nonanoate (non-preferred name)

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The eye of each animal treated with the anaesthetic but not with the test item served as control.

Duration of treatment / exposure:

Animals were dosed once only on the day of dosing (Day 1). Each animal was treated with 0.1 mL aliquot of the test item onto the right eye.

Observation period (in vivo):

The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after the end of dosing.

Number of animals or in vitro replicates:

3 animals/group

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 h post-dose observation.

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24 h

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

The read-across application is justified in the analogue justification. Based on the available data, the target and source substances are considered to be unlikely to show differences in eye irritancy potential. These results indicate that the test item, Trimethylolpropane Tripelargonate, has no relevant irritating effect on the eye of the rabbit.

Executive summary:

The acute eye irritation of Trimethylolpropane Tripelargonate was investigated in rabbits. A 0.1 mL aliquot of the test item was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed approximately 1, 24, 48, and 72 hours after dosing. No significant irritation at either the conjunctivae, iris or cornea was recorded in any treated animal during the study. There were no signs of pain/distress after dosing. Changes in body weight were not remarkable. There was no indication of a systemic effect related to treatment. These results indicate that the test item, Trimethylolpropane Tripelargonate, has no relevant effect on the eye of the rabbit.