Registration Dossier
Registration Dossier
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EC number: 911-369-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09-05-1977 - 31-05-1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- different scoring system
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Modified Federal Hazardous Substances Labelling Act Method
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- tricyclo[5.2.1.0²,⁶]dec-3-en-8-yl acetate; tricyclo[5.2.1.0²,⁶]dec-4-en-8-yl acetate
- EC Number:
- 911-369-0
- Molecular formula:
- C12H16O2
- IUPAC Name:
- tricyclo[5.2.1.0²,⁶]dec-3-en-8-yl acetate; tricyclo[5.2.1.0²,⁶]dec-4-en-8-yl acetate
- Test material form:
- liquid
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 weeks
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- at 15 min., 1, 2, and 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
-
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- 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:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal: 2, 3
- 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:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test substance caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not an eye irritant
- Remarks:
- according to EU CLP (EC 1272/2008 and its amendments)
- Conclusions:
- The test substance is not eye irritating.
- Executive summary:
The primary eye irritation potential of Cyclacet was investigated in a study similar to OECD Test Guideline 405 (Acute Eye Irritation / Corrosion). A single administration of Cyclacet in the eye of 3 rabbits caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated. Mean chemosis, conjunctivae and iris scores at the 24, 48, and 72 hour time point were 0.33 in 1 animals and 0 in the other two animals. The effects seen in the one animal was reversible within one day. Corneal opacity scores were 0.67, 0.33, and 0 for the three animals respectively. The corneal opacity was absent within three days. It is concluded that Cyclacet is not an eye iritant.
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