2-ethylhexyl 3,5,5-trimethylhexanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: guideline test wihout GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 3,5,5-trimethylhexanoate

EC Number:

275-073-7

EC Name:

2-ethylhexyl 3,5,5-trimethylhexanoate

Cas Number:

70969-70-9

Molecular formula:

C17H34O2

IUPAC Name:

2-ethylhexyl 3,5,5-trimethylhexanoate

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harveys Lake, Pemnsylvania.
- Housing: Individually housed in stainless steel wire bottomed cages in an environmentally controlled room
- Diet (e.g. ad libitum): Purina rabbit pellets ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle.

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml of test material

Duration of treatment / exposure:

The upper and lower lids of one eye were gently held together for one second, before releasing; the eyes were not rinsed/washed afterwards.

Number of animals or in vitro replicates:

six healthy young, adult rabbits

Details on study design:

Six healthy young adult albino rabbits exhibiting no ocular defects or corneal defects were selected for testing. The test animals were each uniquely identified. One-tenth of a milliliter of the test material was placed on the everted lower lid of one eye of each rabbit. The upper and lower lids were gently held together for one second before releasing, to prevent loss of the test material. The contra lateral eye of each rabbit remained untreated and served as a control. Ocular lesions were evaluated by the method of Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

110

Remarks on result:

other: Individual scores not available from report

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

from all animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

110

Remarks on result:

other: Individual scores not available from report

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test material is considered to be non-irritating to the eyes of rabbits.

Executive summary:

Primary eye irritation was performed to assess the irritating potential of test substance 2-ethylhexyl 3,5,5-trimethylhexanoate. Six healthy young adult albino rabbits exhibiting no ocular defects or corneal defects were selected for testing. One-tenth of a milliliter of the test material was placed on the everted lower lid of one eye of each rabbit. The upper and lower lids were gently held together for one second before releasing, to prevent loss of the test material. 2-ethylhexyl 3,5,5-trimethylhexanoate was found to cause a Maximum Mean Total Score of 0.0. at 24, 48 and 72 hours after application, and thus is considered non-irritant to eyes.