Ethyl 3-ethoxypropionate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study equivalent to OECD guideline 402.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 3-ethoxypropionate

EC Number:

212-112-9

EC Name:

Ethyl 3-ethoxypropionate

Cas Number:

763-69-9

Molecular formula:

C7H14O3

IUPAC Name:

ethyl 3-ethoxypropanoate

Details on test material:

- Name of test material (as cited in study report): UCAR® Ester EEP (Ethyl 3-Ethoxypropionate)
- Physical state: liquid
- Analytical purity: 99% (GC)

- Storage condition of test material: Room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.0 to 3.0 kg
- Fasting period before study: no
- Housing:no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped, intact skin of the trunk
- % coverage: no data
- Type of wrap if used: impervious sheeting. As necessary for larger doses, gauze is wrapped around the trunk over the sample to prevent leakage . Vet rap® Bandaging Tape is wrapped over the impervious sheeting and the animal is returned to its cage for the contact period .

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data. After the contact period, excess fluid is removed.
- Time after start of exposure:24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Doses are varied by adjusting the volume or weight of the test material .
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2.0, 4.0, 8.0, 16.0 ml/kg

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 24 hours
- Frequency of observations and weighing:
- Gross necropsy of survivors performed: yes(At death or sacrifice, each animal i s subjected to gross pathologic evaluation.)
- Other examinations performed: clinical signs, body weight. Observations for skin reaction are made at one hour, 7 days and 14 days after the contact period.

Dosage levels for the toxicity tests normally differ by a factor of 2 in a geometric series, but may differ by other constant factors if required. The maximum dosage for the percutaneous ests is 16 ml/kg. Dosages are reduced until significant signs of toxicity are not observed.

Statistics:

LD50's and the estimated LD50 slopes are calculated by the moving average method (Thompson, 1947; Weil, 1983) and are based on a 14-day observation period.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

4.29 mL/kg bw

95% CL:

2.66 - 6.91

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

4.92 mL/kg bw

95% CL:

3.05 - 7.94

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

4 080 mg/kg bw

95% CL:

2 530 - 6 570

Effect levels 4

Sex:

female

Dose descriptor:

LD50

Effect level:

4 680 mg/kg bw

95% CL:

2 900 - 7 550

Mortality:

16.0 ml/kg: 5/5 males and 5/5 females died
8.0 ml/kg: 3/5 males and 4/5 females died
4.0 ml/kg: 4/5 males and 2/5 females died
2.0 ml/kg: 0/5 males and 0/5 females died

Clinical signs:

other: Local dermal effect s included erythema, edema, necrosis , desquamation (on one), ecchymosis and scabs (on one). Sluggishness, salivation (in 2), unsteady gait (in 2), lacrimation (in one), nasal discharge (in one) and prostration were among the signs

Gross pathology:

Gross pathologic findings included red and mottled lungs, lungs of one with tan areas, red tracheas, red thymuses and red or white foci on the kidneys (of 2).

Other findings:

Not applicable

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of Ethyl 3-Ethoxypropionate following single dermal application to male and female rabbits is 4080 and 4680 mg/kg bw respectively.

Executive summary:

By the percutaneous route, the LD50 for male rabbits was 4.29 ml/kg. The LD₅₀ for females was 4.92 ml/kg. Local dermal effects included erythema, edema, necrosis, desquamation (on one), ecchymosis and scabs (on one). Sluggishness, salivation (in 2), unsteady gait (in 2), lacrimation (in one), nasal discharge (in one) and prostration were among the signs of toxicity observed. Time to death ranged from one to 6 days. Gross pathologic findings included red and mottled lungs, lungs of one with tan areas, red tracheas, red thymuses and red or white foci on the kidneys (of 2).