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Toxicological information

Skin irritation / corrosion

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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-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 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

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)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
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.