Registration Dossier
Registration Dossier
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EC number: 201-740-9 | CAS number: 87-33-2
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A reliable secondary source, summarising ISDN pharmaco-toxicological properties, was used. However, the primary sources were not revisited in order to verify their contents; for this reason reliability score 2 was used. The used secondary source has been updated on January, 2011; therefore it covers the most updated literature on the substance.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- No information
- Year:
- 1 999
- Bibliographic source:
- Physicians' desk reference
- Reference Type:
- secondary source
- Title:
- No information
- Year:
- 2 011
- Bibliographic source:
- Drugdex Drug Evaluation: DRUGDEX® System. Thomson Reuters, Greenwood Village, Colorado.
Materials and methods
- Study type:
- poisoning incident
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No detailed information is available.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerol trinitrate
- EC Number:
- 200-240-8
- EC Name:
- Glycerol trinitrate
- Cas Number:
- 55-63-0
- Molecular formula:
- C3H5N3O9
- IUPAC Name:
- 1,3-dinitrooxypropan-2-yl nitrate
Constituent 1
Method
- Type of population:
- general
- Reason of exposure:
- other: therapeutic
Results and discussion
Any other information on results incl. tables
The average methemoglobin level measured was 0.2%; these results were comparable to those observed in parallel patients who received placebo.
Applicant's summary and conclusion
- Conclusions:
- Nitrate ions liberated during metabolism of isosorbide dinitrate can oxidize hemoglobin into methemoglobin. When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1 to 2 mg/kg intravenously.
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