Registration Dossier
Registration Dossier
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EC number: 236-752-3 | CAS number: 13474-25-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-01-28 and 1985-03-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: according to OECD guideline, but not GLP conform
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-methyl-1-vinyl-1H-imidazolium chloride
- EC Number:
- 236-752-3
- EC Name:
- 3-methyl-1-vinyl-1H-imidazolium chloride
- Cas Number:
- 13474-25-4
- Molecular formula:
- C6H9N2.Cl
- IUPAC Name:
- 1-ethenyl-3-methyl-2,3-dihydro-1H-imidazol-1-ium chloride
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main
- Age at study initiation: no data
- Weight at study initiation: 2.92 kg (male), 3.04 kg (female)
- Housing: individually in cage made of stainless steel with wire mesh walk floors (floor area: 40 cm x 51 cm)
- Diet: about 130 g per animal per day (Kliba 341, 4 MM, Klingeltalmuehle AG, CH-4303 Kaiseraugust)
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- Single application to the conjunctival sac of the right eyelid.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2 males, 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: none
SCORING SYSTEM: according to OECD scoring system
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
All animals showed redness and sweling at 1 hour after application.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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