[Toxicity study of cefmatilen hydrochloride hydrate (S-1090) (6)--Six-month repeated oral dose toxicity study in dogs].
A six-month repeated oral dose toxicity study of Cefmatilen hydrochloride hydrate (S-1090) at dose levels of 40, 100 and 250 mg potency/kg/day was conducted in male and female beagle dogs. No toxicologically significant changes were observed in general conditions of all animals. Reddish-brown feces (due to chelated products of S-1090 or its decomposition products with Fe3+ in the diet) were observed in all treated groups. Plasma irons showed a tendency to increase in the males and females of the 250 mg potency/kg group. However, as no changes suggesting anemia or hepatic injury were observed in this group, the change of plasma iron was considered to have no toxicological significance. No toxicologically significant changes were observed in other examination items. The plasma S-1090 concentrations increased in a manner less than dose-proportional. Based on the above results, the NOAEL of S-1090 was assessed to be 250 mg potency/kg/day.
Sameshima
H
H
Shin Nippon Biomedical Laboratories, Ltd., 2438 Miyanoura, Yoshida, Kagoshima 891-1394, Japan.
Ueda
T
T
Haruyama
E
E
Chihaya
Y
Y
Mizushima
Y
Y
Ueno
M
M
Moriyama
T
T
Kii
Y
Y
Kato
I
I
D000284:Administration, Oral; D000818:Animals; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D002511:Cephalosporins / Q000097:blood / Q000633:toxicity*; D004285:Dogs; D004334:Drug Administration Schedule; D004435:Eating / Q000187:drug effects; D005260:Female; D006309:Hearing / Q000187:drug effects; D007501:Iron / Q000097:blood; D008297:Male; D009780:Occult Blood; D009929:Organ Size / Q000187:drug effects; D016482:Urinalysis
D002511:Cephalosporins; D007501:Iron; C419864:cefmatilen