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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:
20 June 2005 - 12 July 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with OECD guideline and GLP regulations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl acrylate
EC Number:
205-438-8
EC Name:
Ethyl acrylate
Cas Number:
140-88-5
Molecular formula:
C5H8O2
IUPAC Name:
ethyl acrylate
Details on test material:
- Name of test material (as cited in study report): Ethyl acrylate (EA)
- Substance type: Pure Active Substance
- Physical state: Liquid
- Analytical purity: 99.95 % (according to Analytical report No.: 0003820104-081104-22_1)
- Lot/batch No.: 13671724UO
- Stability under test conditions: Stable
- Test substance No.: 04/0651-1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 7 months
- Weight at study initiation: 3.60 kg - 3.87 kg
- Housing: Single housing
- Diet: Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day )
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h darkness


Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Clipping of the fur
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the undiluted test substance



Duration of treatment / exposure:
1 hour and 4 hours
Observation period:
14 days
Number of animals:
1 animal for 1 h exposure
3 animals for 4 h exposure
Details on study design:
TEST SITE
- Area of exposure: Right Flank for exposure of 1 h and Left flank for exposure of 4 h
- % coverage: 2.5 cm x 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol / water (1 : 1)
- Time after start of exposure: 1h and 4 h


SCORING SYSTEM: According to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables


The exposure period of 1 hour, performed with one animal, caused slight or moderate erythema during the observation period. The cutaneous reactions were reversible within 14 days after removal of the patch. The average score (24 to 72 hours) for irritation was calculated to be 2.0 for erythema and 0.0 for edema. After the exposure period of 4 hours, slight to marked erythema was observed in the animals during the course of the study. The cutaneous reactions were reversible in all animals within 14 days after removal of the patch. The average score (24 to 72 hours) for irritation was calculated to be 2.2 for erythema and 0.0 for edema.

Considering the described cutaneous reactions as well as the average score for irritation, ethyl acrylate showed a skin irritation potential under the test conditions chosen.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU