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EC number: 240-347-7 | CAS number: 16219-75-3
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to guideline study. Well documented study which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative acute toxicity and primary irritancy of the ethylidene and vinyl isomers of norbornene.
- Author:
- Ballantyne B, Myers R and Klonne D.
- Year:
- 1 997
- Bibliographic source:
- J. Applied Toxicology 17, 211-221.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Method not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 5-ethylidene-8,9,10-trinorborn-2-ene
- EC Number:
- 240-347-7
- EC Name:
- 5-ethylidene-8,9,10-trinorborn-2-ene
- Cas Number:
- 16219-75-3
- Molecular formula:
- C9H12
- IUPAC Name:
- 5-ethylidenebicyclo[2.2.1]hept-2-ene
- Details on test material:
- - Test substance: 5-Ethylidene-2-norbornene (CAS No. 16219-75-3)
- Purity: >99% as measured flame ionization gas chromatography
- Source: Union Carbide Corporation, Institute, West Virginia.
.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- A volume of 0.1 or 0.01 ml undiluted ENB was applied to the conjunctival sac of one eye of each rabbit.
- Observation period (in vivo):
- Eyes were examined for signs of ocular and periocular inflammation and injury at 1, 4, and 24hr and 2,3,7 days postinstillation.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Iritis and conjunctival irritation were scored according to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 hour observations
- Score:
- 0.23
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 hour observations
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 hour observations
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour observations
- Score:
- 0.07
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 hours
- Irritant / corrosive response data:
- Iritis or corneal injury were not observed. At 0.1 mL, there was slight conjunctival hyperemia, which began to resolve after 24 hr, was minimal by 2 days and all eyes normal by 7 days. Slight chemosis was at a maximum at 1-4 hr and resolved by 2 days. At 0.01 mL the only findings were mild conjunctival hyperemia and discharge of less than 4 hr duration
Any other information on results incl. tables
Mean and range of scores for eye irritation
produced by ENB instilled in the rabbit eye
Mean (and range) of scores
Conjunctiva
Norbornene Observation Hyperemia Chemosis
(volume) time
ENB 1 h 1.0 (All l) 0.2 (0-1)
(0.1 ml) 4 h 1.0 (All 1) 0.7 (0-2)
24 h 0.3 (0-1) 0.2 (0-1)
2 days 0.2 (0-1) 0.0
3 days 0.2 (0-1) 0.0
7 days 0.0 0.0
ENB 1 h 0.7 (0-1) 0.0
(0.01 ml) 4 h 0.0 0.0
24 h 0.0 0.0
2 days 0.0 0.0
3 days 0.0 0.0
7 days 0.0 0.0
Conjunctiva
Norbornene Observation Discharge Iritis
(volume) time
ENB 1 h 0.5 (0-1) 0.0
(0.1 ml) 4 h 0.8 (0-2) 0.0
24 h 0.2 (0-1) 0.0
2 days 0.0 0.0
3 days 0.0 0.0
7 days 0.0 0.0
ENB 1 h 0.3 (0-1) 0.0
(0.01 ml) 4 h 0.0 0.0
24 h 0.0 0.0
2 days 0.0 0.0
3 days 0.0 0.0
7 days 0.0 0.0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Based on EU implementation
- Conclusions:
- ENB is a slight transient irritant to the rabbit eye.
- Executive summary:
Ballantyne et al (1997) published results showing that ENB is slightly irritating to the rabbit eye.
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