Ethyl 3-ethoxypropionate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 404.

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 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Male or female New Zealand White rabbits are dosed with 0.5 ml (or 0.5 g for solids, moistened with water or other suitable vehicle). The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. Smaller amounts are given if 0.5 ml (or 0.5 g) is lethal. The test material is applied to each of 6 rabbits , which are restrained for the 4-hr contact period. Excess sample i s removed after contact. Skin reaction is scored, by the method of Draize (given below), at one hour, one day, 2 days, 3 days, 7 days, and, depending on the local skin reaction, possibly 10 and 14 days after dosing.

GLP compliance:

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)

Test animals

Species:

rabbit

Strain:

New Zealand White

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:
- Housing: no data
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:


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

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied:0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: guaze patch and loosely covered with impervious sheeting.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data. However, excess is removed after contact.
- Time after start of exposure: 4 hour


SCORING SYSTEM: Draize: one hour; one day; 2 days; 3 days; 7 days;

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Reversibility:

fully reversible within: 2 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Reversibility:

fully reversible within: 2 days

Irritant / corrosive response data:

A 4 hour application of 0.5 ml of Ethyl 3-Ethoxypropionate to occluded rabbit skin resulted in minor transient erythema and edema on only one of 6 rabbits. The skin of all 6 rabbits had a normal appearance after 2 days.

Other effects:

One rabbit died after 2 days from unknown causes. There was no indication that this death was related to the dose.

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a rabbit (4-hr occluded) irritation test, minor transient erythema and edema on one of 6 rabbits from 0.5 ml; irritation subsided after 2 days. The mean scores for both edema and erythema were 0.1.

Executive summary:

A 4-hour application of 0.5 ml of UCAR® Ester EEP to occluded rabbit skin resulted in minor transient erythema and edema on only one of 6 rabbits. The skin of all 6 rabbits had a normal appearance after 2 days. One rabbit died after 2 days from unknown causes. There was no indication that this death was related to the dose. The mean scores for both edema and erythema were 0.1.