Registration Dossier
Registration Dossier
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EC number: 240-347-7 | CAS number: 16219-75-3
Acute Toxicity: oral
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:
- 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:
- 1 997
- Bibliographic source:
- J. Applied Toxicology 17, 211-221.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- 5-ethylidene-8,9,10-trinorborn-2-ene
- EC Number:
- 240-347-7
- EC Name:
- 5-ethylidene-8,9,10-trinorborn-2-ene
- Cas Number:
- 16219-75-3
- Molecular formula:
- C9H12
- IUPAC Name:
- 5-ethylidenebicyclo[2.2.1]hept-2-ene
- 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.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system 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:
- other: 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 piloerect
- 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:
- GHS criteria not met
- Remarks:
- Based on EU implementation
- 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.
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