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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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.