Registration Dossier
Registration Dossier
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EC number: 444-140-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 444-140-4
- EC Name:
- -
- Cas Number:
- 18934-00-4
- Molecular formula:
- C12H22O3
- IUPAC Name:
- 3-ethyl-3-{[(3-ethyloxetan-3-yl)methoxy]methyl}oxetane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Nature of substance: undiluted liquid
Test animals / tissue source
- Species:
- other: Rabbit (New Zealand White)
Test system
- Amount / concentration applied:
- 1 mL
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.67
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.33
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.33
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- Scattered or diffuse corneal opacity was noted in two
treated eyes at the 24 and 48-hour observations and
persisted in one treated eye at the 72-hour observation.
Iridial inflammation was noted in all treated eyes one hour
after treatment, in two treated eyes at the 24-hour
observation and persisted in one treated eye at the 48-hour
observation.
Moderate conjunctival irritation was noted in all treated
eyes one and 24 hours after treatment.
Moderate conjunctival irritation was noted in two treated
eyes with minimal conjunctival irritation in one treated eye
at the 48-hour observation. Moderate conjunctival
irritation was noted in one treated eye with minimal
conjunctival redness in two treated eyes at the 72-hour
observation.
All treated eyes appeared normal at the 7-day observation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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