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Toxicological information

Acute Toxicity: dermal

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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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
4.29 mL/kg bw
95% CL:
2.66 - 6.91
Sex:
female
Dose descriptor:
LD50
Effect level:
4.92 mL/kg bw
95% CL:
3.05 - 7.94
Sex:
male
Dose descriptor:
LD50
Effect level:
4 080 mg/kg bw
95% CL:
2 530 - 6 570
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:
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 of toxicity observed.
Body weight:
Recorder on Test days 0, 7 and 14. The lower doses, 2.0 and 4.0 ml/kg gain weight through the duration of the test. When compared to Test day 0, dose group 8.0 ml/kg had decreased body weight on test days 7 and 14.
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).