Ethyl linoleate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2010-06-14 - 2010-06-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP and guideline compliant study. This endpoint is covered by data on eye irritation from the read-across substance (CAS: 91051-53-5). As the major component of the test item is ethyl linoleate, the data are considered valid for assessment of ethyl linoleate (CAS: 544-35-4).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, safflower-oil, Et esters

EC Number:

293-106-3

EC Name:

Fatty acids, safflower-oil, Et esters

Cas Number:

91051-53-5

IUPAC Name:

91051-53-5

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan, Belton, Leics, England
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: individually
- Diet: ad libitum (Global Diet 2030 from Harian Tekiad®, Mucedola, Milanese, Italy)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days prior to treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.1 -23.4
- Humidity (%): 38 - 81
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:

CORNEAL IRRITATION
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity (may include slight dulling of normal luster) 0
Scattered or diffuse areas of opacity, details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea. iris not discernible through the opacity 4

Area of cornea involved:
No ulceration or opacity 0
One quarter or less but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4

IRIS
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2

CONJUNCTIVAL IRRITATION
Redness (refers to palpebrae and sclera, excluding cornea and iris):
Blood vessels normal 0
Some blood vessels definitely hyperaemic {injected) 1
Diffuse, crimson color, individual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis (refers to lids and/or nictitating membranes):
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids half closed 3
Swelling with lids more than half dosed 4

Discharge
No discharge (may include small amounts observed in inner canthus of normal animals) 0
Any amount different from normal and/or lacrimation 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs (considerable area around the eye) 3

TOOL USED TO ASSESS SCORE: Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp and fluorescin.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The installation of the test substance resulted in redness of the conjunctivae after 1hour. The irritation had completely resolved within 24 hours in all animals. No iridial irritation or corneal opacity was observed and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the test results the test item has not to be classified.

Executive summary:

The acute eye irritation study was carried out based on the OECD guideline No. 405.

Single samples of 0.1 ml of the test item were instilled into one eye of each of th three rabbits. Observations were made after 1, 24, 48 and 72 h after instillation. The instillation of the test item resulted in slight redness of the conjunctivae. The irritation had completely resolved within 24 h in all animals. Based on these results the test item has not to be classified as eye irritant.