Ethyl octanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11.09.2000 - 15.09.2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl octanoate

EC Number:

203-385-5

EC Name:

Ethyl octanoate

Cas Number:

106-32-1

Molecular formula:

C10H20O2

IUPAC Name:

ethyl octanoate

Test animals / tissue source

Species:

rabbit

Strain:

other: SPF albino rabbits of the stock Chbb:HM(SPF) - Littlerussian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.3 - 2.8 kg b.w.
- Housing: During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123", ad libitum
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% + 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): Light was on from 6 a.m. to 6 p.m..

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48, and 72 hours

Number of animals or in vitro replicates:

4

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing : 20 ml 0.9% sodium chloride solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: See 'Any other information on materials and methods'

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.3

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

One hour after application of the test article animal No. 1884 showed a diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal. In animal No. 1885 a diffuse, crimson red conjunctiva with individual vessels not easily discernible were observed as well as a swelling above normal. Animal No. 1886 showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal. In animal No. 1887 some conjunctival vessels definitely injected and a swelling above normal were observed.
24 hours after application of the test article animals No. 1884, No. 1885, No. 1886 and No. 1887 showed some conjunctival vessels definitely injected and a swelling above normal.
48 and 72 hours after application of the test article all four animals were free of any signs of eye irritation.

ASSESSMENT
According to the CLP Regulation (EC) No 1272/2008 the substance is considered to have irreversible effects on the eye (category 1) if, when applied to the eye of an animal, a substance produces:
1. at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or
2. at least in 2 of 3 tested animals, a positive response of: corneal opacity >= 3 and/or iritis > 1.5
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

The substance is considered to be irritant to the eyes (category 2) if, when applied to the eye of an animal, a substance produces:
1. at least in 2 of 3 animals, a positive response of: corneal opacity >= 1 and/or iritis >= 1 and/or conjunctival redness >= 2 and/or conjunctival oedema (chemosis) >= 2
2. calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not eye irritating.

Executive summary:

In the current study the potential eye irritant effect of the test item was assessed according to the OECD 405 and EEC Guideline B.5 and in compliance to GLP. The day before testing both eyes of the animals were examined to ensure there were no defects or irritation.

In this test only one eye was treated while the other eye remains untreated and serves as control.

0.1 ml of the test article was placed in one eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The lids were then gently held together for 1 second.

The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. After the first 24 hour reading Fluorescein was instilled. After rinsing the eyes were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours after the treatment.

The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal another three rabbits were included in the study.

Therefore, in total 4 female albino rabbits were exposed to the test article. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing.

No or only slight signs of irritation were observed on the treated eyes.

The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated: Cornea opacity 0.0; Iris lesion 0.0; Redness of conjunctiva 0.3 and Oedema of conjunctiva 0.3. All findings were reversible within 48h.

Based on these results, the test item shall not be classified as eye irritating.

According to the CLP regulation the test item shall not be classified as eye irritating