Registration Dossier

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:
other: Comparable to guideline study.

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 404 (Acute Dermal Irritation / Corrosion)
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

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
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:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test site was wiped moist gauze to remove excess ENB.
- Time after start of exposure: 4 hrs

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hour observations
Score:
2.03
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hour observations
Score:
1.63
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
There was mild to moderate erythema and edema, most marked at 1-2 days and thereafter slowly resolving, completely resolved by 14 days. Desquamation was observed in all animals from day 7. Necrosis was not seen.

Any other information on results incl. tables

                   Average (and range) of scores
Inspection Time      Erythema        Edema

1 hour               1.2 (0-2)       1.5 (1-2)
1 day                2.3 (2-3)       2.2 (1-3)
2 days               2.3 (2-3)       1.7 (1-2)
3 days               1.5 (1-2)       1.0 (0-2)
7 days               1.2 (1-2)       1.0 (1-3)
10 days              0.2 (0-1)       0.0
14 days              0.0             0.0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
ENB is a moderate irritant to rabbit skin.
Executive summary:

Ballantyne et al (1997) published results showing that ENB is a moderate irritant to rabbit skin (4 -hr occlusive exposure). All symptoms reversed within 14 days.