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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral Toxicity)
Deviations:
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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: between 200-300 grams

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Animals were dosed orally by gavage (liquid).
Doses:
1.0, 2.0, 2.83, 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 276 mg/kg bw
95% CL:
1 944 - 2 670
Sex:
female
Dose descriptor:
LD50
Effect level:
5 071 mg/kg bw
95% CL:
2 876 - 8 915
Clinical signs:
Clinical signs of toxicity were observed in dose groups of 2.0 mL/kg and greater and include sluggishness, lacrimation, kyphosis, unsteady gait and diarrhea, which appeared within 30-45 min postdosing, The days following dosing, some rats showed piloerection, intermitant tremors and perinasal/periocular encrustaion. Survivors recovered from these effects between 1 and 6 days postdosing. 1.0 mL/kg was a no-effect dose. 
Body weight:
Body weights were unaffected for survivors.
Gross pathology:
The only consistent finding at necropsy of rats that died was mottled dark pink or red lungs. No gross pathology was seen in survivors at necropsy. 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 values indicate a moderate degree of toxicity. Females had a LD50 value numerically about twice that for males. The marginally significant difference in LD50 values between males and females were due mainly to the greater variability of females to the peroral toxicity of ENB.
Executive summary:

Ballantyne et al (1997) published acute oral LD50 values of 2276 mg/kg (males) and 5071 mg/kg (females) for ENB in rats.