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Toxicological information

Developmental toxicity / teratogenicity

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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:
2011
Bibliographic source:
HSDB - Hazardous Substances Data Bank
Reference Type:
secondary source
Title:
No information
Year:
2011
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

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

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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