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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions (report not available for the submitter, no further details available; occlusive dressing [worst case]). Presumably rapid evaporation; discussion of reliability see also overall remarks.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
methyl vinyl ether (MVE)
no further data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animals were kept in rooms designed to maintain adequate environmental conditions, and were given a commercial diet and municipal water ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin
Amount / concentration applied:
undiluted, 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
Observations for skin reactions were made at one hour, and after 1, 2, 3, 7, 10, and 14 days per the Draize scoring method.
Number of animals:
Six male and female New Zealand White Rabbits were used for the study.
Details on study design:
Rabbits were subjected to 4 hours of contact with 0.5 ml of the undiluted, cold test material (not specified further), retained under occlusive dressings on clipped, intact skin of the animals' trunk. The animal was returned to the home cage for the 4 hour contact period. Excess test material was removed after the contact period to diminish ingestion.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: one hour, and after 1, 2, 3, 7, 10, and 14 days after exposure
Score:
0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
other: occlusive exposure to cold liquid
Irritation parameter:
edema score
Basis:
mean
Time point:
other: one hour, and after 1, 2, 3, 7, 10, and 14 days after exposure
Score:
0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
other: occlusive exposure to cold liquid
Irritant / corrosive response data:
There was no erythema, edema, or other irritation on any of 6 rabbits from 0.5 ml of undiluted sample.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
There was no erythema, edema, or other irritation in any of 6 New Zealand White rabbits one hour, and 1, 2, 3, 7, 10, or 14 days after exposure (occlusive for 4 h) to 0.5 mL of undiluted, cold liquid test substance.