Registration Dossier
Registration Dossier
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EC number: 223-054-9 | CAS number: 3710-30-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2012
- Deviations:
- yes
- Remarks:
- no pretreatment with topical anesthetics and systemic analgesics; 6 animals
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
Test material
- Reference substance name:
- Octa-1,7-diene
- EC Number:
- 223-054-9
- EC Name:
- Octa-1,7-diene
- Cas Number:
- 3710-30-3
- Molecular formula:
- C8H14
- IUPAC Name:
- octa-1,7-diene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: H. Fortkamp, Lengerich, Germany
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 2.45 - 2.94 kg
- Housing: individually in steel grid floor cages
- Diet: Ssniff K Alleindiaet fuer Kaninchen (Ssniff Versuchstier GmbH, Soest, Germany); ad libitum
- Water: mains water; ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated right eye of each animal served as control.
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 1 h and 1, 2, 3, 4 and 7 days after application - Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS EYES: fluorescein (before treatment)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 1-h reading: score = 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of 4 animals (#2-#5)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 1-h reading: score = 1 in 2/4 animals; score = 2 in 2/4 animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1-h reading: score = 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 1-h reading: score = 1 in 4/6 animals; score = 2 in 2/6 animals
- Irritant / corrosive response data:
- One hour after instillation of the test substance moderate chemosis (grade 2) associated with moderate reddening (grade 2) were observed in 2/6 animals. In the remaining 4 animals slight chemosis (grade 1) and slight reddening (grade 1) were noted. One day after treatment chemosis was no longer apparent in any animal and eye reaction was limited to slight reddening (grade 1) in the majority of animals. Two days after treatment only one animal showed slight reddening (grade 1) and 3 days after treatment no longer any effects were observed.
- Other effects:
- Initial pain reaction on instillation varied from practically no initial pain (a few blinks only; normal within one or two minutes) to slight initial pain (rabbit blinks and tries to open eye, but the reflexes close it).
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Slight eye irritating effects (conjunctivae redness and swelling) were observed in all animals after instillation of the test substance. Almost all effects were reversible within 24 h and not later than 48 h. Thus, classification for eye irritation is not warranted.
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