Ethyl (2E,4Z)-2,4-decadienoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 15-22, 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl (2E,4Z)-2,4-decadienoate

EC Number:

221-178-8

EC Name:

Ethyl (2E,4Z)-2,4-decadienoate

Cas Number:

3025-30-7

Molecular formula:

C12H20O2

IUPAC Name:

ethyl deca-2,4-dienoate

Test material form:

not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3426-04699

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the dark below 10 degrees C under N2 atmosphere.

Test animals / tissue source

Species:

rabbit

Strain:

other: little white Russian, Chbb-SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH
- Weight at study initiation: 2.2-2.6 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): K4 Alleindiat fur Kaninchen , ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 degree C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15 x per hour
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

IN-LIFE DATES: From: September 15, 1986 To: September 22, 1986

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cc
- Concentration (if solution): 98.8%

Duration of treatment / exposure:

72 hrs

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein, hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1.83

Max. score:

110

Reversibility:

fully reversible within: 48 hrs

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Redness of the conjunctiva (maximum score of 2), and discharge (maximum score of 2) were seen in all three animals at the 1 hr observation. Redness (maximum score of 1) was seen in two of the animals at the 24 hr observation. No other signs of irritation were observed. There were no signs of irritation in any animal at the 48 and 72 hr observations, and at the Day 7 observation.

Any other information on results incl. tables

	Animal 17966	Animal 18070	Animal 18322
Cornea – 1 hour	0	0	0
Iris -1 hour	0	0	0
Conjunctiva (Redness) – 1 hour	1	2	2
Conjunctiva (Swelling) – 1 hour	0	0	0
Conjunctiva (Discharge) – 1 hour	1	2	1
Cornea – 24 hours	0	0	0
Iris -24 hours	0	0	0
Conjunctiva (Redness) – 24 hours	0	1	1
Conjunctiva (Swelling) – 24 hours	0	0	0
Conjunctiva (Discharge) – 24 hours	0	0	0
Cornea – 48 hours	0	0	0
Iris -48 hours	0	0	0
Conjunctiva (Redness) – 48 hours	0	0	0
Conjunctiva (Swelling) – 48 hours	0	0	0
Conjunctiva (Discharge) – 48 hours	0	0	0
Cornea – 72 hours & 7 days	0	0	0
Iris -72 hours & 7 days	0	0	0
Conjunctiva (Redness) – 72 hours & 7 days	0	0	0
Conjunctiva (Swelling) – 72 hours & 7 days	0	0	0
Conjunctiva (Discharge) – 72 hours & 7 days	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not irritating to the eye.

Executive summary:

The eye irritation potential of the test substance was determined in an OECD Guideline 405 study. Three rabbits were exposed to 0.1 cc of test substance. The other eye remained untreated as a control. Some redness and discharge was seen at the 1 hr and 24 hr observations, but there were no signs of irritation at the 48 hr observation. The irritation index was 1.83/110. The test substance is therefore not irritating to the eye.