Registration Dossier

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: scientific acceptable and sufficient documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Small cellulose lobes (2.5 x 2.5 cm²) with 500 µl of tert-butylisocyanate was applied to the inner surface of one ear per animal; exposure time was 1hour. The test-substance was fixed by a plaster. The post exposure observation time was 7 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl isocyanate
EC Number:
216-544-9
EC Name:
tert-butyl isocyanate
Cas Number:
1609-86-5
Molecular formula:
C5H9NO
IUPAC Name:
tert-butyl isocyanate
Details on test material:
Test substance: tert-butyl isocyanate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
1 hour(s)
Observation period:
7 days
Number of animals:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 5, 6, 7 days
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 5, 6, 7 days
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Other effects:
Scurf was observed at the reading after at 1 and 24 hours

Any other information on results incl. tables

A strong erythema and edema was observed until the end of the post-exposure period. Tert-butylisocyanate is strong irritating/corrosive at the inside of a rabbit ear after an application time of 1 hour

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Executive summary:

Small cellulose lobes (2.5 x 2.5 cm²) with 500 µl of tert-butylisocyanate was applied to the inner surface of one ear per animal; exposure time was 1hour. The test-substance was fixed by a plaster. The post exposure observation time was 7 days.

Scurf was observed at the reading after at 1 and 24 hours. A strong erythema and edema was observed until the end of the post-exposure period. Tert-butylisocyanate is strong irritating/corrosive at the inside of a rabbit ear after an application time of 1 hour.