Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

To investigate the ulcerogenic properties of TVX 3934, it was administered two times orally by gavage (5 ml/kg) to male Wistar rats at doses of 5, 10, 20, and 40 mg/kg (10 animals/dose). TVX 3934 was formulated in Lutrol-water-mixture (8+2). At the third day animals were sacrificed and the mucosa of the gastrointestinal tract was examined macroscopically.
[Troponwerke, Scientific Report No. 51430, 1990-02-20]

Additional information

TVX 3934 (equivalent to Acemetacin-tert.-butylester) has antiphlogistic properties and might therefore, as other antiphlogistics, adversely affect the mucosa of the gastrointestinal tract.

In the above described study TVX 3934 dose-dependently affected the mucosa of the gastrointestinal tract.The ulcerogenic potency (ED50) of TVX 3934 has been determined as 17.4 mg/kg. 1/10 animals of the highest dose group had an ulcus of the duodenal mucosa.

The study was not conducted according to GLP or Guidelines and the report has some deficiencies. Therefore, the results can not be used for a possible classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP).