Morphological studies on the subchronic toxicity of a standardized liver- and spleen-extract
Leder, G.H.; Leder, O.
Arzneimittel-Forschung 40(2 Part 1): 187-189
1990
ISSN/ISBN: 0004-4172 PMID: 2334459 Document Number: 4350
A short-term safety study on the liver- and spleen-extract Factor AF2 has been carried out. Daily injections of 4 or 33.3 mg/kg body weight for six weeks were not followed by drug-induced changes. Daily doses of AF2 equivalent to normal clinical administration - 250 mg or 2 g/patient - produced no adverse drug-related effects in rats. In particular, no local fibrinous inflammation or diffuse adhesive peritonitis were found. Furthermore, there were no changes in the vessels or other organs such as would have suggested a hypersensitivity reaction. Damage was observed in hearts and livers of all groups. While granulomas within the liver after the injection of corynebacterium parvum are common, the cause of the histological changes in this study remains unknown. It may be supposed that the daily injections were followed by infection, or that subclinical infection occurred from non pathogen-free housing conditions. Likewise, injuries due to the injection method chosen are possible. In conclusion, it can be claimed that this short-term study of AF2 did not reveal any characteristic changes in the drug-treated groups.
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