Registration Dossier
Registration Dossier
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EC number: 203-696-6 | CAS number: 109-69-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan. 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 1987-02-24
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-chlorobutane
- EC Number:
- 203-696-6
- EC Name:
- 1-chlorobutane
- Cas Number:
- 109-69-3
- Molecular formula:
- C4H9Cl
- IUPAC Name:
- 1-chlorobutane
- Details on test material:
- - Name of test material (as cited in study report): n-Butylchlorid
- Storage condition of test material: ambient conditions
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Spain S.p.A (Como) and bred by P.O.A.D.A Mandello Lario (CO), Italy
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually housing in stainless steel cages (69x45x51cm) with grid floors
- Diet: ad libitum anti-biotic free pelleted laboratory diet (Altromin MSK)
- Water: ad libitum drinking water via water bottles
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% (w/w) - Duration of treatment / exposure:
- single treatment (right eye),
eye not rinsed - Observation period (in vivo):
- 1, 24, 48, 72 hours and 7 days after treatment
- Number of animals or in vitro replicates:
- 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: average 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
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