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Diss Factsheets

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:
2002
Bibliographic source:
Physicians' desk reference - 56th ed p.3527
Reference Type:
secondary source
Title:
No information
Year:
2011
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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

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.

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