[Single dose toxicity studies of lactitol (NS-4) in mice and rats].
The single dose toxicity studies of lactitol, a hepatic encephalopathy drug, were performed in ddY mice and SD rats of both sexes by administering the drug orally, intravenously or subcutaneously. The drug was administered as a single dose followed by a 14-day observation. Oral LD50 values of lactitol were estimated to be between 23 and 30 g/kg in male mice, approximately 30 g/kg in female mice, and more than 30 g/kg in male and female rats. Lethal dose was more than 10 g/kg intravenously and subcutaneously in mice and rats of both sexes. The signs of toxicity in mice and rats observed following the administration of this drug included the following: decreased spontaneous movement [p.o., i.v., s.c.]; diarrhea, oligopnea or prone position, transient decreased body weight [p.o]. There were no treatment-related changes in gross examination. Based on these results, it was found that lactitol had a very low acute toxicity when administered by a single dose method in mice and rats.
Okazaki
S
S
Gotemba Laboratory, Bozo Research Center Inc., Shizuoka-ken, Japan.
Suwa
K
K
Hamasu
Y
Y
Sumi
N
N
D000284:Administration, Oral; D000818:Animals; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007928:Lethal Dose 50; D008297:Male; D051379:Mice; D008815:Mice, Inbred Strains; D009043:Motor Activity / Q000187:drug effects; D051381:Rats; D017207:Rats, Sprague-Dawley; D013402:Sugar Alcohols / Q000008:administration & dosage / Q000633:toxicity*; D015431:Weight Loss / Q000187:drug effects
D013402:Sugar Alcohols; C014635:lactitol