Registration Dossier
Registration Dossier
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EC number: 266-380-7 | CAS number: 66492-51-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (5-ethyl-1,3-dioxan-5-yl)methyl acrylate
- EC Number:
- 266-380-7
- EC Name:
- (5-ethyl-1,3-dioxan-5-yl)methyl acrylate
- Cas Number:
- 66492-51-1
- Molecular formula:
- C10H16O4
- IUPAC Name:
- (5-ethyl-1,3-dioxan-5-yl)methyl acrylate
- Details on test material:
- - Name of test material (as cited in study report): SR 349
- Physical state: Viscous liquid
- Analytical purity: no data
- Lot/batch No.: HYJ1628
- Expiration date of the lot/batch: Jan 1994
- Storage condition of test material: room temperature in the dard
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 2.3 - 3.1kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): SDS Stanrab (P) ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: all rabbits were acclimatised
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light):12h/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1ml
- Duration of treatment / exposure:
- substance was not washed out
- Observation period (in vivo):
- 7 days
1h, 1, 2, 3, 4, 7 days after instillation - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Day 1-7
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Day1-7
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: Day 1-7
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Day 1-7
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2,3
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1day
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2,3
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Other effects:
- No signs of toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test substance was not irritating to the eyes of three rabbits.
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