Registration Dossier
Registration Dossier
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EC number: 224-167-6 | CAS number: 4221-98-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-02-22 to 2000-05-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Feb. 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Jan. 1997
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (R)-5-isopropyl-2-methylcyclohexa-1,3-diene
- EC Number:
- 224-167-6
- EC Name:
- (R)-5-isopropyl-2-methylcyclohexa-1,3-diene
- Cas Number:
- 4221-98-1
- Molecular formula:
- C10H16
- IUPAC Name:
- (5R)-2-methyl-5-(propan-2-yl)cyclohexa-1,3-diene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 2.7 - 3.3 kg
- Housing: Individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 20°C +/- 3°C
- Humidity: 55% +/- 15%
- Air changes: 10 times/hour
- Photoperiod: 12 hours light/12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hours (Fluorescein was instilled)
SCORING SYSTEM:
Cornea
Opacity-degree of density (area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffuse area of opacity (other than slight dulling of normal luster), details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Complete corneal opacity, iris not discernible: 4
Iris
Normal: 0
Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any thereof)
iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal: 0
Some vessels definitely injected: 1
More diffuse, deeper crimson red, individual vessels not easily discernible: 2
Diffuse beefy red: 3
Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4
TOOL USED TO ASSESS SCORE: hand-slit lamp with white and UV-light/ magnifying glass with 2 x magnification (biomicroscope) / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritating to the eye of rabbit.
- Executive summary:
The acute eye irritation/corrosion study was conducted according to OECD guideline no. 405 and GLP.
The test substance was applied in one eye of four female albino rabbits. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as 7 days after dosing.
Slight to well-defined signs of irritation were observed on the treated eyes.
All effects were fully reversible within 7 days.
For the four animals the mean scores after 24/48 and 72 hours was for cornea opacity: 0, 0, 0, 0; iris:0, 0, 0, 0; conjunctival redness: 1.0, 0.67, 0.67, 1.0; chemosis: 0.67, 0.33, 0.33, 0.33, all signs were fully reversible at 7 days.
Based on these results the test substance is not irritating to the eye of rabbit.
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