Registration Dossier
Registration Dossier
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EC number: 211-063-0 | CAS number: 628-96-6
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Metabolism of ethylene glycol dinitrate and its influence on the blood pressure of the rat
- Author:
- Clark, D.G. and Litchfield, M.H.
- Year:
- 1 967
- Bibliographic source:
- British Journal of Industrial Medicine, 24:320-325
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A group of rats was subcutaneously injected with EGDN and another with EGMN (ethylene glycol mononitrate); blood pressure and blood concentrations of the parent compounds and inorganic nitrate/nitrite were measured at various time points up to 96 hours after injection.
- GLP compliance:
- no
- Remarks:
- Study predates USFDA GLPs
Test material
- Reference substance name:
- Ethylene dinitrate
- EC Number:
- 211-063-0
- EC Name:
- Ethylene dinitrate
- Cas Number:
- 628-96-6
- Molecular formula:
- C2H4N2O6
- IUPAC Name:
- ethane-1,2-diyl dinitrate
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- other: Alderley Park (albino)
- Sex:
- female
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- corn oil
- Duration and frequency of treatment / exposure:
- 96 hours (rats were injected with either EGDN or EGMN and observed for 96 hours)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
65 mg/kg EGDN; 46 mg/kg EGMN
- No. of animals per sex per dose / concentration:
- 75 rats in the EGDN group; 40 rats in the EGMN group
- Control animals:
- no
- Details on dosing and sampling:
- After subcutaneous injection, blood from five rats from each group was taken and analyzed for EGDN, EGMN and inorganic nitrate and nitrite.
- Statistics:
- Statistical methods were not used. Results were provided as means ± standard deviation. Coefficients of variation were calculated for the points on the curves showing the rise and fall of the compounds in blood at the various time points.
Results and discussion
Main ADME results
- Type:
- metabolism
- Results:
- EGDN concentrations peaked at 0.5 hours post-injection, and EGMN concentrations peaked at 3 hours post-injection. Concentrations of EGDN, EGMN and nitrite reached baseline within 12 hours, while nitrate reached baseline after 12 hours.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- EGDN rapidly metabolizes to EGMN (ethylene glycol mononitrate) and then to inorganic nitrate and nitrite
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: bioaccumulation potential cannot be judged based on study results
Study design focused on measuring blood levels of EGDN and metabolites following a single subcutaneous injection.
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