Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study already available
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; restrictions: no details about the test substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl vinyl ether
EC Number:
203-718-4
EC Name:
Ethyl vinyl ether
Cas Number:
109-92-2
Molecular formula:
C4H8O
IUPAC Name:
ethyl vinyl ether
Details on test material:
ethyl vinyl ether (EVE), no further data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: GAUKLER ; OFFENBACH (FRG)
- Age at study initiation: no data
- mean weight at study initiation: 2.8 (males) and 2.6 kg (female)
- Housing: singly
- certified diet and tap water ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL undiluted TS
Duration of treatment / exposure:
4 hour(s)
Observation period:
30-60 minutes after removal of the patches as well as 24, 48 and 72 hours after the beginning of exposure
Number of animals:
3
Details on study design:
The fur was clipped at least 15 hrs before treatment.
Application: A pad (2.5 x 2.5 cm) soaked with 0.5 ml of undiluted TS was placed to the shaved, intact rabbit's dorsal skin (secured by porous dressing). At the end of the contact period excess test substance was washed off.
Observations, examinations: Skin reactions were examined at 1, 24, 48, and 72 hours after patch removal.
Data evaluation: Skin reactions were scored according to the table of Draize contained in the OECD TG 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: no skin reaction
Irritation parameter:
edema score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: no skin reaction
Irritant / corrosive response data:
No skin reaction was noted in any of the animals at any reading, i.e. the score for erythema and edema was 0 at all readings in all animals. Therefore, the mean score was 0 for both erythema and edema.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
No skin reaction was noted at any reading 1, 24, 48, or 82 h after semiocclusive dermal exposure to 0.5 mL undiluted test substance for 4 h in any of 3 White Vienna rabbits.