Registration Dossier

Administrative data

Endpoint:
eye 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:
100 µl test substance was applied into the conjuctival sac of 2 rabbits. Post exposure time was 7 days. Eyes were examinated after application of test substance up to 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 / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Amount applied: 100 other: µl
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.8
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days

Any other information on results incl. tables

Immediately after application a moderate/strong redness and a moderate/very strong swelling were observed. Cornea was clouded and cauterized. All  findings persist up to end of observation period

Applicant's summary and conclusion

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

100 µl test substance was applied into the conjuctival sac of 2 rabbits. Post exposure time was 7 days. Eyes were examinated after application of test substance up to 7 days.

Immediately after application a moderate/strong redness and a moderate/very strong swelling were observed. Cornea was clouded and cauterized. All  findings persist up to end of observation period. Tert-butyl isocyanate is strong irritant and corrosive to the cornea