Registration Dossier
Registration Dossier
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EC number: 203-509-8 | CAS number: 107-66-4
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: scientifically acceptable and sufficient documented
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:
- 100 µl test substance was applied into the conjunctival sac of 2 rabbits. Post exposure time was 7 days. Eyes were examined after application of test substance up to 7 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Dibutyl hydrogen phosphate
- EC Number:
- 203-509-8
- EC Name:
- Dibutyl hydrogen phosphate
- Cas Number:
- 107-66-4
- Molecular formula:
- C8H19O4P
- IUPAC Name:
- dibutyl hydrogen phosphate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not reversible
Any other information on results incl. tables
The test substance causes corrosion to the cornea.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Executive summary:
The test substance was (100 µl) 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.
Effects on the cornea, iris, conjunctiva and chemosis were persistent up to the end of the observation period (7 days).
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