Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: published result, well documented study

Data source

Reference
Reference Type:
publication
Title:
Nephrotoxicty of Pravadoline Maeleate (WIN 48098-6) in Dogs: Evidence of Maleic Acid-Induced Acute Tubular Necrosis
Author:
Everett RM, Descotes G, Rollin M, Greener Y, Bradford JC, Benzinger DP, Ward SJ
Year:
1993
Bibliographic source:
Fundam. Appl. Toxicol. 21: 59-65

Materials and methods

Type of study / information:
Type: other: nephrotoxicity
Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity greater than 99.5%

Results and discussion

Any other information on results incl. tables

No mortality occurred during the 24-h post observation
period. Acute tubular necrosis, characterized by necrosis
of contiguous epithelial cells of the S1, S2, and S3 segments
of the proximal tubules, was observed in all treated
groups. In the lowest dose group, incidence of acute tubular
necrosis was given in 1/3 males and 3/3 females.

Applicant's summary and conclusion