Registration Dossier
Registration Dossier
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EC number: 608-554-0 | CAS number: 3090-56-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo study already available
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1967-09-26 to 1967-10-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Please refer to "Principles of method"
- Principles of method if other than guideline:
- No guideline was available while the study was conducted. Therefore BASF-internal standard was used.
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethanol, 2-(ethenylthio)-
- EC Number:
- 608-554-0
- Cas Number:
- 3090-56-0
- Molecular formula:
- C4H8OS
- IUPAC Name:
- Ethanol, 2-(ethenylthio)-
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- No specific details for test material were provided.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- No details were provided.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 0.05 mL
- Duration of treatment / exposure:
- Eyes were not rinsed.
- Observation period (in vivo):
- 9 days
- Number of animals or in vitro replicates:
- 2 animals
- Details on study design:
- SCORING SYSTEM:
Company internal grading was used during study performance. After guidelines were implemented this internal scoring was translated into the Draize scheme.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Other effects:
- - Lesions and clinical observations: Secretion was obsereved for up to 48 h. Both animals developed remaining scar tissue on the eye lid of the treated eye after 72 h. After 72 h blood was detected in the eye of animal 2.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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