Registration Dossier
Registration Dossier
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EC number: 201-740-9 | CAS number: 87-33-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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:
- 2 011
- Bibliographic source:
- HSDB - Hazardous Substances Data Bank
- Reference Type:
- secondary source
- Title:
- No information
- Year:
- 2 011
- Bibliographic source:
- REPROTOX®
Materials and methods
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:
- Isosorbide dinitrate
- EC Number:
- 201-740-9
- EC Name:
- Isosorbide dinitrate
- Cas Number:
- 87-33-2
- Molecular formula:
- C6H8N2O8
- IUPAC Name:
- isosorbide dinitrate
- Reference substance name:
- Isosorbide mononitrate
- EC Number:
- 240-197-2
- EC Name:
- Isosorbide mononitrate
- Cas Number:
- 16051-77-7
- Molecular formula:
- C6H9NO6
- IUPAC Name:
- (3R,3aS,6S,6aR)-6-hydroxyhexahydrofuro[3,2-b]furan-3-yl nitrate
Constituent 1
Constituent 2
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: unspecified
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data
Effect levels (maternal animals)
- Dose descriptor:
- dose level:
- Effect level:
- > 240 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- other: These doses are about 100 times the recommended human dose on a weight basis and up to 38 times the human dose on a surface area basis
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Remarks on result:
- other: No detailed information is available
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No increase in malformation is observed in this study. The read-across approach is applied in order to transfer the isosorbide mononitrate information to isosorbide dinitrate.
Applicant's summary and conclusion
- Conclusions:
- Available information do not suggest any possible effects on developmental toxicity and teratogenicity.
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