Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-740-9 | CAS number: 87-33-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- genetic toxicity in vitro
- 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:
- 2 002
- Bibliographic source:
- Physicians' desk reference - 56th ed p.3527
- Reference Type:
- secondary source
- Title:
- No information
- Year:
- 2 011
- Bibliographic source:
- HSDB - Hazardous Substances Data Bank
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No detailed information is available. Performed tests include Ames, mouse lymphoma, human lymphocyte, mouse micronucleus assay/test.
- GLP compliance:
- not specified
- Type of assay:
- other: available information refers to the overall assessment of results from several type of studies not described in detail
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
Results and discussion
- Remarks on result:
- other: (migrated information): negative
Any other information on results incl. tables
Isosorbide mononitrate did not produce gene mutations or chromosome aberrations. The read-across approach is applied in order to transfer the isosorbide mononitrate information to isosorbide dinitrate.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for mutagenicity.
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.
