5-vinylnorborn-2-ene

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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

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 404 (Acute Dermal Irritation / Corrosion)

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-vinyl-2-norbornene

IUPAC Name:

5-vinyl-2-norbornene

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

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

undiluted 0.5 ml

Duration of treatment / exposure:

4 hour(s)

Observation period:

Sites of application were inspected for signs of inflammation and injury at 1 hr and 1,2,3,7,and 10 days.

Number of animals:

3 males, 3 females

Details on study design:

TEST SITE
- Area of exposure: dorsal trunk
- Type of wrap if used: gauze loosely covered with polythene sheeting.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, but excess material removed with water moistened gauze.
- Time after start of exposure: 4 hr

SCORING SYSTEM: Erythema and edema were scored and recorded on a 5 point scale (0= no reaction, 4= severe reaction).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hour observations

Score:

1.46

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hour observations

Score:

0.43

Max. score:

4

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

There was marked erythema and edema at 1-2 days and thereafter slowly resolving, completely resolved by 10 days. Desquamation was observed in all animals from day 7. Necrosis was not seen.

Any other information on results incl. tables

Inspection time after removed of wrap	Erythema score. Average (range)	Edema score. Average (range)
1 hour	0.7 (0 -1)	1.2 (1 -2)
1 day	2.0 (1 -3)	0.7 (0 -1)
2 days	1.2 (0 -2)	0.3 (0 -1)
3 days	1.2 (0 -2)	0.3 (0 -1)
7 days	0.2 (0 -1)	0.3 (0 -1)
10 days	0	0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

VNB is a mild to moderate irritant to rabbit skin.

Executive summary:

Ballantyne et al (1997) published results showing that the substance ethylidene norbornene is a mild to moderate irritant to rabbit skin (4 -hr occlusive exposure). All symptoms reversed within 10 days.