Ethyl 3-phenyloxirane-2-carboxylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 March 2000 - 01 April 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Information is used for read across to Ethylphenylglycidate

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

February 1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2,3-epoxy-3-phenylbutyrate

EC Number:

201-061-8

EC Name:

Ethyl 2,3-epoxy-3-phenylbutyrate

Cas Number:

77-83-8

Molecular formula:

C12H14O3

Test animals / tissue source

Species:

rabbit

Strain:

other: Chbb:HM(SPF)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Littlerussian from BI Pharma KG, 88397 Biberach
- Age at study initiation: No data.
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: Individually in PPO cages with perforated floor.
- Diet: Free access to pelleted complete rabbit diet (Altromin 2123" from Altromin, D-32791 Lage, Lippe)
- Water: Free access to quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: No data.

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated and served as control.

Amount / concentration applied:

Amount applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Single instillation on Day 1

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

4 females

Details on study design:

STUDY DESIGN
The test material was applied undiluted in 4 animals.

TREATMENT
In accordance with OECD 405. The test substance is placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids are then gently held together for about one second. The other eye serves at control.

REMOVAL OF TEST SUBSTANCE
-Washing: Yes, 24 hours after instillation of the test substance.

OBSERVATIONS
- Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.

SCORING SYSTEM:
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405.

TOOL USED TO ASSESS SCORE: 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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: animal #1, #2, #3 and #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

other: animal #1, #2, #3 and #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

other: animal #1, #2, #3 and #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

other: animal #1, #2 and #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after application of the test article animal #1 showed a diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal. In animal #2 were observed some conjunctival vessels definitely injected, a swelling above normal and a discharge with moistening of the lids and hairs just adjacent to lids. The animal #3 showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal. In animal #4 were observed a diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge with moistening of the lids and hairs just adjacent to lids.
24 hours after application of the test article in animals #1, #2 and #4 were observed some conjunctival vessels definitely injected and a swelling above normal. Animal #3 showed some conjunctival vessels definitely injected.
48 hours after application of the test article all four animals were free of any signs of eye irritation.
72 hours after application of the test article all four animals were free of any signs of eye irritation, too.

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant.

Remarks:

According to EU CLP Regulation (EC) No. 1272/2008 and its amendments

Conclusions:

In an eye irritation study with 4 rabbits, performed according to OECD 405 guideline and GLP principles, all rabbits had slight reddening of the conjuctivae observed at 24 hours only. Three rabbits showed also showed slight chemosis at 24 hours only. All signs of irritation were reversible within 48 hours, the substance is not an eye irritant.

Executive summary:

The substance was tested in an eye irritation test in 4 rabbits according to OECD TG 405 test guideline and GLP principles. All rabbits had slight reddening of the conjuctivae observed at 24 hours only. Three rabbits also showed slight chemosis at 24 hours only. All signs of irritation were reversible within 48 hours, the substance is not an eye irritant.