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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 25 - April 22, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: Two animals are dosed at 5.0 g/kg dermally. If either of these animals die, then three additional groups are given various doses to determine the LD50. If neither animal in the initial dose group die, then an additional eight animals are dosed at 5.0 g/kg.
- Short description of test conditions: Dermal exposure for 24 hrs with occlusive covering.
- Parameters analysed / observed: mortality, toxicity, pharmacological effect, body weight, gross pathology

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

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

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 2.1-2.4 kg
- Fasting period before study: no
- Housing: 2 per cage in suspended wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled

Administration / exposure

Type of coverage:

occlusive

Details on dermal exposure:

TEST SITE
- Area of exposure: abdomen
- % coverage: 10
- Type of wrap if used: gauze covered with plastic

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 11.7-13.3 cc

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped
- Time after start of exposure: 24 hrs

Duration of exposure:

24 hrs

Doses:

5.0 g/kg

No. of animals per sex per dose:

1 Female
9 Male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (observations), pretest and prior to sacrifice (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology, dermal irritation

Dermal irritation scoring:
Erythema
0 - no erythema
1 - very slight erythema (barely perceptible)
2 - well defined erythema
3 - moderate to severe erythema
4 - very severe erythema (beet redness) to slight eschar formation (injuries in depth)

Edema
0 - no edema
1 - very slight edema (barely perceptible)
2 - slight edema (edges of area well defined by definate raising)
3 - moderate edema (raised approximately 1 mm)
4 - severe edema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Yellow nasal discharge (2 animals) Few feces (2 animals) Ptosis (1 animal)

Gross pathology:

Lungs congested (4 animals)
Intestinal contents fluid (1 animal)
Treated skin eschar (4 animals)

Other findings:

40% of the test substance remained on the animals, gauze, and occlusive binding after the binding was removed. All but one animals showed severe erythema with flaking by the day 7 observation. In four of the animals, the severe erythema and flaking was still present on day 14. The remaining animal showed well defined erythema on day 7 with flaking, and still showed slight erythema with flaking on day 14. All animals showed very slight to slight edema by day 1, and four animals still showed very slight edema on day 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 > 5 g/kg.

Executive summary:

The acute dermal toxicity of ethyl decedienoate was determined. Two animals were dosed at 5.0 g/kg dermally.  If either of these animals die, then three additional groups are given various doses to determine the LD50.  If neither animal in the initial dose group die, then an additional eight animals are dosed at 5.0 g/kg. As the two initial animals did not die, an additional 8 animals were dosed at 5.0 g/kg. Dermal exposure was for 24 hrs with occlusive covering. Animals were observed for mortality, toxicity, pharmacological effect, body weight, dermal irriation and gross pathology. No animals died during the study. The acute dermal LD50 in rabbits is > 5 g/kg.