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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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 404 (Acute Dermal 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: less than 10 degrees C under N2 atmosphere

Test animals

Species:

rabbit

Strain:

other: little white Russian, Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH
- Weight at study initiation: 2.1-2.6 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 day

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 17, 1986 To: October 2, 1986

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cc
- Concentration (if solution): 98.8%

Duration of treatment / exposure:

4 hrs

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Gauze covered by a polyethylene film, which was then covered by a plastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hrs

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1, 24, 48, 72 hrs
6, 9, 12, 14 days
SCORING SYSTEM:
- Method of calculation: Edema and eschar were evaluated on a scale of 0-4 (0 no erythema, 4 severe erythema and eschar). Edema was also evaluated on a scale of 0-4 (0 no edema, 4 severe edema).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hrs

Score:

4.25

Max. score:

8

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 9 days

Irritant / corrosive response data:

All animals exhibited redness and swelling at the first oberservation (1 hr) which per persisted through Day 6. Scabbing and cracking was still seen in all animals at Day 14.

Any other information on results incl. tables

 

	Animal 19781	Animal 19801	Animal 30003
Redness – 1 hour	2	1	2
Swelling -1 hour	1	1	2
Redness – 24 hours	2	2	2
Swelling -24 hours	2	1	2
Redness – 48 hours	3 (slight yellowing)	3	3
Swelling -48 hours	3	2	2
Redness – 72 hours	3 (slight yellowing)	3	3
Swelling - 72 hours	2	2	2
Redness – 6 days	3 (scabbing, cracking, yellow-brown)	3 (scabbing, cracking)	3 (scabbing, cracking, yellow-brown)
Swelling – 6 days	2	1	2
Redness – 9 days	Scabbing, cracking	Scabbing, cracking	Scabbing, cracking
Swelling – 9 days	--	--	--
Redness – 12 days	Scabbing, cracking	Scabbing, cracking	Scabbing, cracking
Swelling – 12 days	--	--	--
Redness – 14 days	Scabbing, cracking	Scabbing, cracking	Scabbing, cracking
Swelling – 14 days	--	--	--

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance is moderately irritating to skin.

Executive summary:

The skin irritation potential of the test substance was determined in an OECD Guideline 404 study. 3 male rabbits were exposed to 0.5 cc of test substance for 4 hrs. The test substance was then removed, and observations made at 1, 24, 48, and 72 hrs after removal, and also at 6, 9, 12, and 14 days after removal. All animals showed evidence of irritation that was not fully resolved by Day 14. The test substance is moderately irritating to skin.