Registration Dossier
Registration Dossier
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EC number: 201-740-9 | CAS number: 87-33-2
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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 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
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- dose level:
- Effect level:
- > 750 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: Generation not specified (migrated information)
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: Generation not specified (migrated information)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
No effects were shown on fertility of isosorbide dinitrate apart from a slightly decreasing in perinatal survival, a reduction of weight and the inhibition of lactation, judged as not statistically nor biologically relevant.
The read-across approach is applied in order to transfer the isosorbide mononitrate information to isosorbide dinitrate.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
