Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: information from secondary source
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, summaring 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

Reference
Reference Type:
secondary source
Title:
No information
Year:
2011
Bibliographic source:
RTECS - Registry of Toxic Effects of Chemical Substances

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

Test animals

Species:
rabbit

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours

Results and discussion

In vivo

Results
Irritation parameter:
other: not stated
Basis:
other: not stated
Remarks on result:
other: No detailed information is available.
Irritant / corrosive response data:
The dosed used on rabbits may cause a mild skin irritation.

Applicant's summary and conclusion

Conclusions:
Available information suggest a possible mild skin irritation. However, information is not available in detail and conclusions can not be drawn.