Registration Dossier
Registration Dossier
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EC number: 222-598-4 | CAS number: 3547-33-9
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: No information on test procedures provided, except for a reference to Sponsor Approved Protocol. However, thorough results and scoring system used were provided.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-(octylthio)ethanol
- EC Number:
- 222-598-4
- EC Name:
- 2-(octylthio)ethanol
- Cas Number:
- 3547-33-9
- Molecular formula:
- C10H22OS
- IUPAC Name:
- 2-(octylsulfanyl)ethan-1-ol
- Reference substance name:
- Ethanol, 2-(octylthio)-
- IUPAC Name:
- Ethanol, 2-(octylthio)-
- Reference substance name:
- 2-hydroxyethyl-n-octyl sulfide
- IUPAC Name:
- 2-hydroxyethyl-n-octyl sulfide
- Details on test material:
- - Name of test material (as cited in study report): 2-hydroxyethyl-n-octyl sulfide
- Stability under test conditions: Stable under all usual conditions of storage and use. Avoid highly alkaline emulsifiers in emulsion concentrates.
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2627-3360 grams
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- The test substance was applied to the eyes (unwashed) and the animals were observed for 7 days.
- Observation period (in vivo):
- Animals were observed for 7 days (at 1h, 24h, 48h, 72h, 4 days and 7 days).
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize Scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 10
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 5
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4.2
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 4.2
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.8
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 9.3
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 5.7
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 4
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0.3
- Max. score:
- 20
Any other information on results incl. tables
Overall irritation score: ca. 8 of max. 110 (mean) (Time point: 1 hour)
Overall irritation score: ca. 23.5 of max. 110 (mean) (Time point: 24 hours)
Overall irritation score: ca. 10.7 of max. 110 (mean) (Time point: 48 hours)
Overall irritation score: ca. 9 of max. 110 (mean) (Time point: 72 hours)
Overall irritation score: ca. 4 of max. 110 (mean) (Time point: 4 days)
Overall irritation score: ca. 0.3 of max. 110 (mean) (Time point: 7 days; not fully reversible within: 7 days)
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (irritating to eyes)
- Remarks:
- Criteria used for interpretation of results: other: EU CLP
- Conclusions:
- The test substance was considered irritating to the eyes based on the above listed adverse effects, which were all reversible within 7 days, except for conjunctival redness in 1 rabbit.
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