Registration Dossier
Registration Dossier
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EC number: 216-544-9 | CAS number: 1609-86-5
Eye irritation
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:
- 1 980
- 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
- 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:
- 2-isocyanato-2-methylpropane
- Details on test material:
- Test substance: tert-butyl isocyanate
Constituent 1
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
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
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