Fatty acids, essential, Et esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

June 14th, 2010 - June 24th, 2010 (in life phase)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance ethyl linoleate (CAS No. 544-35-4). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Single samples of 0.1 mL of test substance were instilled into one eye of each of three rabbits.
Observations were made 1, 24, 48 and 72 hours after instillation.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl linoleate

EC Number:

208-868-4

EC Name:

Ethyl linoleate

Cas Number:

544-35-4

Molecular formula:

C20H36O2

IUPAC Name:

ethyl octadeca-9,12-dienoate

Details on test material:

- Name of test material (as cited in study report): ethyl linoleate
- CAS No. of test material (as cited in study report): 544-35-4
- Physical state: hazy yellow liquid
- Purity: 75% ethyl linoleate
- Impurities: 11% Octadecenoic acid ethylester (Ethyl Oleate), 6% Hexadecanoic acid ethylester, 3% Octadecanoic acid ethylester, 3% Octadecadienoic acid glycerol monoester
- Storage: at room temperature in the dark
- Stability under storage conditions: stable

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 1.0 kg
- Housing: individually in labelled cages with perforated floors
- Diet: Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC (actual range: 19.1 - 23.4ºC)
- Humidity (%): 40-70% (actual range: 38 - 81 %)
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
The test substance was instilled as delivered by the sponsor.
Prior to weighing the amount of test substance, the test substance was heated to 39.5°C for 10 minutes

Duration of treatment / exposure:

single eye instillation

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: Draize system, the eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.

TOOL USED TO ASSESS SCORE:
Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.

The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner one week later, after considering the degree of eye irritation observed in the first animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 tested animals and mean of readings at

Time point:

other: 24,48 and 72 h

Score:

0

Max. score:

3

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 tested animals and mean of readings at

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 tested animals and mean of readings at

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 tested animals and mean of readings at

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Instillation of 0.1 mL test substance into one eye of each of three rabbits resulted in redness of the conjunctivae. 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.No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU