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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material: 2-methoxyethyl cyanoacetate

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hour exposure
Observation period:
4, 24 and 48 hours
Number of animals:
Total of six animals
Details on study design:
TEST SITE
- Area of exposure: 1.5 x 1.5 inch
- % coverage: 100
- Type of wrap if used: Areas of exposure were covered by ply gauze squares. The patches were secured to the area by thin bands of adhesive tape. The entire trunks of the animals were then wrapped in clear plastic trunk bands.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following this initial reading, all test sites were washed with appropriate solvent to prevent further exposure.
- Time after start of exposure: 4h

SCORING SYSTEM: Draize, 1944

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4, 24, 48
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4, 24, 48
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4, 24, 48
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4, 24, 48
Score:
0
Max. score:
0
Reversibility:
other: not applicable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A primary skin irritation and corrosivity study was performed in the albino rabbit on the test item. No skin irritation was noted in any of the six animals at any of the observations at 4, 24 and 48 h. A primary irritation index of 0.0 was obtained. The test article was therefore regarded as a non-irritant.
Executive summary:

A study similar or equivalent to EU Method B.4 and OECD Guideline 404 (Acute Dermal Irritation / Corrosion) was carried out. A group of six albino rabbits was treated with the test item (occlusive with 4 h exposure). No skin irritation was noted in any of the six animals at any of the observations at 4, 24 and 48 h. A primary irritation index of 0.0 was obtained. The test article was therefore regarded as a non-irritant.

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