5-vinylnorborn-2-ene

Acute Toxicity: dermal

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:

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

. Only two doses given.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

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

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazelton Research Products Inc, Denver, PA
- Weight at study initiation: between 2-3 kg
- Housing: singly in wire mesh cages.
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped dorsal trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no. Excess wiped away after occlusive dressings removed.

Duration of exposure:

24 hr

Doses:

8.0, 16 mL/kg

No. of animals per sex per dose:

High dose group 4, low dose group 5.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations. Weighing at 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Mortality:

One male died in the high dose group on day 4.

Clinical signs:

other: Signs of possible systemic effects were few and included almost immediate vocalization on applying the dose, persisting for about 5-15 min. Sluggishness and laboured breathing were seen with a few males. On removal of the occlusive dressing there was som

Gross pathology:

No gross pathology was observed at necropsy in most survivors, although a few had dark or bright red lungs. The one deceased animal showed mottled liver and multiple black foci in the stomach wall.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Undiluted VNB 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 >16ml/kg (13.8g/kg) for vinyl norbornene in rabbits.