Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
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 403 (Acute Inhalation 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 (CASNo.16219-75-3)
- Purity: >99% as measured flame ionization gas chromatography.
- Source: Union Carbide Corporation, Institute, West Virginia.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: between 194-262 grams (males) and 137-206 grams (females)

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
2206, 2813, or 3431 ppm of ENB vapor in air
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
2 717 ppm
95% CL:
2 318 - 3 184
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
3 015 ppm
95% CL:
2 404 - 3 780
Exp. duration:
4 h
Mortality:
7 of 10 rats died during exposure to 3431 ppm ENB.
Clinical signs:
All 7 rats that died during the period after exposure to ENB developed hindlimb parsalysis, and also showed urogenital area wetness, hypothermia, and absent surface righting and toe and tail pinch reflexes.
Body weight:
Body weights were unaffected for all survivors.
Gross pathology:
No gross pathology was seen in survivors at nescropsy.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The 4-hr LC50 value indicates a moderate degree of vapor toxicity. At these high vapor concentration, signs are predominantly those of a central excitatory nature, particularly hypereactivity, tremors, and convulsions.
Executive summary:

In a reliable study, Ballantyne et al (1997) published acute 4 -hr LC50 values of 2717 ppm (13.5 mg/l) (males) and 3015 ppm (15.1 mg/l) (females) for ENB vapor in rats.