Ethyl enantate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30.08 - 03.09.1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl enantate

EC Number:

203-382-9

EC Name:

Ethyl enantate

Cas Number:

106-30-9

Molecular formula:

C9H18O2

IUPAC Name:

ethyl heptanoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.3 - 2.4 kg bw.
- Housing: individually in PPO cages (floor arca: 2576 cm2) with perforated floor.
- Diet: ad libitum; pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe
- Water: ad libitum; domestic quality drinking water acidified with hydrochloric acid to pH 2.5 (to prevent microbial growth)
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): cycle of 12 hours light and 12 hours darlaiess. Light was on from 06 to 18 h.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

single administration, no rinsing

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 (if done): no

EXAMINATION
- after 1, 24, 48 and 72 hours
- after the first 24h reading, Fluorescein was instilled. The eye was subsequently rinsed with 20 ml 0.9% sodium chloride solution, and examined again using UV-light to detect possible corneal damage.

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:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

One hour alter application of the test article all animals showed some conjunctival vessels definitely injected.
After 24 hours some conjunctival vessels definitely injected were observed in animals No.1590, No.1591 and No. 1592. Animal No. 1589 was free of any signs of eye irritation. After 48 hours only animal No. 1592 showed some conjunctival vessels definitely injected. Animal No.1589, No.1590 and. No. 1591 were free of any signs of eye irritation. After 72 hours animal No. 1592 was free of any signs of eye irritation.

Any other information on results incl. tables

Individual scores

Animal/weight per kg	Cornea	Iris	Conjuctival redness	Chemosis
1589 / 2.3	0.0	0.0	0.0	0.0
1590 / 2.4	0.0	0.0	0.33	0.0
1591 / 2.4	0.0	0.0	0.33	0.0
1592 / 2.4	0.0	0.0	0.67	0.0
Mean	0.0	0.0	0.33	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not eye irritant.

Executive summary:

In the current study the eye irritant effect of the test item was investigated according to the method recommended in the OECD Guideline 405 and the EEC Guideline B.5.

Four female albino rabbits were exposed to 0.1 ml of the test item in the left eye. The right eye remained untreated and served as control.

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 with 20 ml 0.9% sodium chloride solution 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.

Changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing.

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:

Animal	Cornea	Iris	Conjuctival redness	Chemosis
1	0.0	0.0	0.0	0.0
2	0.0	0.0	0.33	0.0
3	0.0	0.0	0.33	0.0
4	0.0	0.0	0.67	0.0
Mean	0.0	0.0	0.33	0.0

According to the CLP regulation the test item should not be classified as an eye irritant.