romurtide and Abnormalities--Drug-Induced

The reproductive toxicity of the anomeric mixture of N2-[(N-acetylmuramoyl)-L-alanyl-D-isoglutaminyl]-N6-stearoyl-L-lysine (MDP-Lys(L18), muroctasin), a new immunomodulator, was investigated in mice and rabbits after subcutaneous injection. Neither the male or female fertility nor the reproductive performance of the mice was affected by doses of up to 1 x 10(4) micrograms/kg. MDP-Lys(L18) elicited no evidence of teratogenicity when injected subcutaneous during the period of organogenesis to pregnant mice at doses of up to 3 x 10(4) micrograms/kg, or to pregnant rabbits at doses of up to 25 micrograms/kg. However, the female mice receiving 3 x 10(4) micrograms/kg showed induration and scabbing of the injection sites. Decrease of maternal body weight and food intake was seen in rabbits at doses of 5 and 25 micrograms/kg. Lacrimation, bloodshot eyes and swelling of eyelid were observed in does at a dose of 25 micrograms/kg. In perinatal and postnatal toxicity study in mice using doses of up to 2 x 10(4) micrograms/kg, a decrease in body weight of dams was seen at a dose of 2 x 10(4) micrograms/kg. Decrease in body weight of pups at birth was observed at a dose of 2 x 10(4) micrograms/kg.

Topics: Abnormalities, Drug-Induced; Acetylmuramyl-Alanyl-Isoglutamine; Adjuvants, Immunologic; Animals; Body Weight; Female; Fertility; Male; Mice; Pregnancy; Pregnancy, Animal; Rabbits