Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Method not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

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:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: between 2-3 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Duration of exposure:
24 hr
Doses:
2.0, 4.0, or 8.0 mL/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 and 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 mL/kg bw
95% CL:
> 7 168
Remarks on result:
other: 95% CL measured in mg/kg
Mortality:
No rabbits died. 
Clinical signs:
Signs of possible systemic effects were few and included almost immediate vocalization on applying the dose, persisting for about 5-15 min. 2 animals showed emaciation, abdominal distension and diarrhea. On removal of the occlusive dressing there was marked erythema and edema in all groups, with the edema persisting for about 1 week. Desquamation, fissuring, ulceration and alopecia were seen at 7 and 14 days in all groups, with scab formation at 7 days. 
Body weight:
Male and female rabbits in the 8.0 mL/kg dose group lost weight during the first week with some regain during the second week. The 4.0 mL/kg males lost weight over the whole post-dosing period. All 2.0 mL/kg animals gained weight.
Gross pathology:
No gross pathology was observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Undiluted ENB produced slight acute percutaneous systemic toxicity and severe irritancy by single 24-hr contact with skin.
Executive summary:

Ballantyne et al (1997) published an acute (24 -hr occlusive exposure) dermal LD50 value of >7168 mg/kg for ENB in rabbits since no rabbits died up to the maximum tested dose.