Registration Dossier
Registration Dossier
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EC number: 200-751-6 | CAS number: 71-36-3
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Butan-1-ol
- EC Number:
- 200-751-6
- EC Name:
- Butan-1-ol
- Cas Number:
- 71-36-3
- Molecular formula:
- C4H10O
- IUPAC Name:
- butan-1-ol
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, own breeding facilities
- Age at study initiation: ca. 3-5 months
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 50 +- 20
- Air changes (per hr): fully air conditioned room
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological sodium chloride solution
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to OECD guideline 405
TOOL USED TO ASSESS SCORE: fluorescein (not at all readings)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 2.11
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 2.89
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
Any other information on results incl. tables
| Time p.a. | 1 h | 24 h | 48 h | 72 h | 7 d | ||||||||||
| Animal No. | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
| Conjunctival swelling | 3 | 3 | 3 | 3 | 3 | 3 | 4 | 3 | 3 | 3 | 3 | 2 | 3 | 3 | 1 |
| Conjunctival reddening | 2 | 2 | 1 | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 2 |
| Iris | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | + | 1 | 1 | + | 1 | 0 |
| Corneal opacity | 1 | 1 | 1 | 2 | 1 | 1 | 4 | 2 | 1 | 4 | 2 | 2 | 4 | 2 | 2 |
| Eye discharge: clear, uncoloured | x | x | x | ||||||||||||
| Eye discharge: white, smeary | x | x | x | x | x | x | x | x | x | x | x | x | |||
| Conjunctiva: white-coloured | x | ||||||||||||||
| Conjunctiva: with bleeding | x | x | x | x | |||||||||||
| Iris: reddened | x | x | x | x | x | x | x | x | x | x | x | x | |||
| Iris: due to intense clouding not readable | x | x | x | ||||||||||||
| Cornea: vascularization - weak distinct | x | ||||||||||||||
| Cornea: vascularization - clearly distinct | x | x | |||||||||||||
| Cornea: rough | x |
+ could not be assesst due to severe opacity
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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