5-vinylnorborn-2-ene

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:

1997

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

Test material information

Constituent 1

Reference substance name:

5-vinylnorborn-2-ene

EC Number:

221-259-8

EC Name:

5-vinylnorborn-2-ene

Cas Number:

3048-64-4

Molecular formula:

C9H12

IUPAC Name:

5-ethenylbicyclo[2.2.1]hept-2-ene

Constituent 2

Reference substance name:

5-ethylidene-2-trinorbornene

IUPAC Name:

5-ethylidene-2-trinorbornene

Details on test material:

- Test substance: 5-vinyl-2-norbornene (CAS 3048-64-4)
- Purity: >99%
- Source: Union Carbide Corporation, South Charleston, West Virginia
.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

A volume of 0.1 ml undiluted substance 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:

3 males, 3 females

Details on study design:

SCORING SYSTEM: Iritis and conjunctival irritation were scored according to Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48, 72 hour observations

Score:

0.53

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Max score seen 1

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48, 72 hour observations

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hour observations

Score:

0.07

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Corneal effects were not observed and therefore not reported in the results above.  Ther was slight  conjunctival hyperemia, which began to resolve after 24 hr, was minimal  by 2 days and all eyes normal by 7 days. A marked chemosis was at a maximum  at 1-4 hr but quickly resolved. Mild transient iritis was seen but resolved within 24hrs.

Any other information on results incl. tables

Mean and range of scores for eye irritation produced by ENB instilled in the rabbit eye. Range shown in brackets.

Observation time	Redness	Chemosis	Iritis
1 hr	1.0 (all 1)	1.2 (1 -3)	0.3 (0 -1)
4 hr	1.0 (all 1)	1.0 (1 -2)	0.2 (0 -1)
24 hr	1.0 (all 1)	0.2 (0 -1)	0
2 days	0.3 (0 -1)	0	0
3 days	0.1 (0 -1)	0	0
7 days	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 vinyl norbornene is slightly irritating to the rabbit eye.