The 12-week oral toxicity of a new synthesised biliary acid derivative
, N-methyl glyco-hyodeoxycholic acid (NMGHDCA), was investigated in do
gs. NMGHDCA was administered orally at dose levels of 100 to 220 and 5
00 mg/kg/day. No deviations from normal were observed in the physical
appearance and general behaviour of the treated animals. Food and wate
r consumption and bodyweight gain of treated groups did not differ fro
m those of control animals. No treatment-related changes were observed
in haematology, serum biochemistry, urinalysis, organ weights and pos
tmortem macroscopic or histopathological examinations. No dose- or gen
der-related differences were observed. The no-effect dose level was es
timated to be 500 mg/kg/day.