Registration Dossier
Registration Dossier
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EC number: 240-347-7 | CAS number: 16219-75-3
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:
- 1 997
- 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)
- 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 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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system 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:
- other: 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 mark
- Gross pathology:
- No gross pathology was observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- 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.
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