Registration Dossier

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. 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:
1997
Bibliographic source:
J. Applied Toxicology 17, 211-221.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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.
.

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:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
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.