Registration Dossier
Registration Dossier
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EC number: 203-860-7 | CAS number: 111-34-2
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: Guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- adopted 1987
- GLP compliance:
- yes
- Remarks:
- (BASF AG, Department of Toxicology)
Test material
- Reference substance name:
- Butyl vinyl ether
- EC Number:
- 203-860-7
- EC Name:
- Butyl vinyl ether
- Cas Number:
- 111-34-2
- Molecular formula:
- C6H12O
- IUPAC Name:
- 1-(ethenyloxy)butane
- Details on test material:
- N-butyl vinyl ether
SUBSTANCE NUMBER: 94/78
LOT NUMBER: LJ 2694/93 VERS. 56, 93
DATE OF MANUFACTURING: 04-NOV-1993
PHYSICAL STATE/APPEARANCE: LIQUID, ACHROMATIC
STORAGE CONDITIONS: ROOM TEMPERATURE
The test substance was stable over the study period.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: GAUKLER ; OFFENBACH (FRG)
- Age at study initiation: young adults (no further details)
- body weight range at study initiation: 2.76-3.58 kg
- Housing: singly
- certified diet and tap water ad libitum
- Acclimation period: 7 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)
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- no washing
- Observation period (in vivo):
- Eye reactions were examined after 1, 24, 48, and 72 h after application
- Number of animals or in vitro replicates:
- 3 (1 male and 2 female)
- Details on study design:
- 0.1 mL of undiluted TS was placed into the conjunctival sack of the rabbit's eye. The substance was not washed out. Effects were scored according to the table of Draize contained in the OECD TG 405. Additionally measured parameters: area of cornea involved and discharge.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: no effects 48 h after application; no effects on iris and cornea at any reading
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: discharge score 1 (max. 3), no effects after 24 h
- Irritant / corrosive response data:
- No corneal opacity was noted in any of the animals at any reading, i.e. the mean score = 0 for all readings in all animals.
Iritis: no effect in any animal at any time, therefore mean score = 0.
Conjunctivae: mild to moderate reddening, discharge and swelling were noted 1 hour after application but no effects were detected 24 h after application except redness score 1 in one rabbit. No effect was noted at 48 and 72 hrs post treatment (study termination). - Other effects:
- no clinical symptoms
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In three White Vienna rabbits the instillation of 0.1 mL of the undiluted test substance into the conjunctival sac of one eye caused reddening (grade 1 - 2) and slight swelling (grade 1) 1 hour after application (no washing). In two rabbits the findings cleared up 24 hours after application or within 48 h in the third rabbit. No effects were noted on cornea or iris.
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