Registration Dossier
Registration Dossier
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EC number: 203-862-8 | CAS number: 111-36-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only 2 animals tested and different observation times for both animals
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- TEST ANIMALS: strain: New Zealand albino sex: no data ADMINISTRATION/EXPOSURE: The undiluted compound was placed in the conjunctival sac of one eye EXAMINATION: observations were made after 1 hour, 24, 48, 120, 144, and 168 hours (one animal) observations were made after 1 hour, 24, 48, 72, 96, and 168 hours (second animal) Both animals were killed after 7 days
- GLP compliance:
- no
Test material
- Reference substance name:
- Butyl isocyanate
- EC Number:
- 203-862-8
- EC Name:
- Butyl isocyanate
- Cas Number:
- 111-36-4
- Molecular formula:
- C5H9NO
- IUPAC Name:
- 1-isocyanatobutane
- Details on test material:
- n-butyl isocyanate, purity: techn. pure
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: 0.1 ml - Duration of treatment / exposure:
- 7 days
- 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:
- animal #1
- Time point:
- other: 1, 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72, 96 h, 7 d
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1, 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 48, 72, 96 h, 7 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 120, 144 h, 7 d
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 120, 144 h, 7 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
Any other information on results incl. tables
SCORE:
Due to distinct swelling and redness of the conjunctiva
immediately after the instillation the determination of
findings of cornea and iris was not possible during the entire
observation period.
Animal 1
Cornea (observation time): 1, 1 (1h 24h)
Iris (observation time): 0, 0 (1h, 2h)
Conjunctiva
redness (observation time): 3, 3, 3, 3, 3, 3 (1h, 24h, 48h,
72h, 96h, 7d)
chemosis (observation time): 3, 3, 4, 4, 4, 4 (1h, 24h, 48h,
72h, 96h, 7d)
Discharge (incl. ichor): 2, 2, 2, 2, 2, 2 (1h, 24h, 48h,
72h, 96h, 7d)
Animal 2
Cornea (observation time): 0 (1h)
Iris (observation time): 0 (1h)
Conjunctiva
redness (observation time): 3, 3, 3, 3, 3, 3 (1h, 24h, 48h,
120h, 144h, 7d)
chemosis (observation time): 4, 4, 4, 4, 4, 4 (1h, 24h, 48h,
120h, 144h, 7d)
Discharge (incl. ichor): 2, 2, 2, 2, 2, 2 (1h, 24h, 48h,
120h, 144h, 7d)
Applicant's summary and conclusion
- Interpretation of results:
- highly corrosive
- Remarks:
- Migrated information
- Executive summary:
TEST ANIMALS: strain: New Zealand albino sex: no data
ADMINISTRATION/EXPOSURE: The undiluted compound was placed in the conjunctival
sac of one eye
EXAMINATION: observations were made after 1 hour, 24, 48, 120, 144, and 168 hours
(one animal) observations were made after 1 hour, 24, 48, 72, 96, and 168 hours
(second animal) Both animals were killed after 7 days
RESULT: highly corrosive
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