Registration Dossier

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.