Registration Dossier
Registration Dossier
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EC number: 223-437-0 | CAS number: 3891-33-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973-12-18 to 1975-03-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable, method equivalent or similar to guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- method applied according to BASF-internal standard
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,4-bis(vinyloxy)butane
- EC Number:
- 223-437-0
- EC Name:
- 1,4-bis(vinyloxy)butane
- Cas Number:
- 3891-33-6
- Molecular formula:
- C8H14O2
- IUPAC Name:
- 1,4-bis(ethenyloxy)butane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.11 - 3.32 kg
- Housing: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: 1973-12-18 To: 1973-12-27
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 0.05 mL of a NaCl solution was applied into the other eye of the same animal
- Amount / concentration applied:
- 0.05 mL
- Duration of treatment / exposure:
- Single instillation into the conjunctival sac of the right eyelid
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was not washed out
SCORING SYSTEM: observed were the parameters redness conjunctivae, chemosis, cornea opacity, and necrosis
Grading system for cornea and chemosis:
"reizlos" Ø: considered as equivalent to Grade 0 according to OECD Guideline 405
"fraglich" (+): considered as equivalent to Grade 1 according to OECD Guideline 405
"leicht" +: considered as equivalent to Grade 2 according to OECD Guideline 405
"stark" ++: considered as equivalent to Grade 3 effect according to OECD Guideline 405
"sehr stark" +++: considered as equivalent to Grade 4 according to OECD Guideline 405
Grading system for conjunctivae:
"reizlos" Ø: considered as equivalent to Grade 0 according to OECD Guideline 405
"leicht" +: considered as equivalent to Grade 1 according to OECD Guideline 405
"stark" ++: considered as equivalent to Grade 2 effect according to OECD Guideline 405
"sehr stark" +++: considered as equivalent to Grade 3 according to OECD Guideline 405
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritating effects observed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritating effects observed
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritating effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritating effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritating effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritating effects observed
- Irritant / corrosive response data:
- After 1 h the treated eye was covered by a smeary layer (reversible after 8 days)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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