[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.
AuthorsS Okazaki, K Suwa, Y Hamasu, N Sumi
JournalThe Journal of toxicological sciences (J Toxicol Sci) Vol. 19 Suppl 3 Pg. 295-9 (Nov 1994) ISSN: 0388-1350 [Print] JAPAN
PMID7837291 (Publication Type: English Abstract, Journal Article)
Chemical References
  • Sugar Alcohols
  • lactitol
  • Administration, Oral
  • Animals
  • Diarrhea (chemically induced)
  • Female
  • Injections, Intravenous
  • Injections, Subcutaneous
  • Lethal Dose 50
  • Male
  • Mice
  • Mice, Inbred Strains
  • Motor Activity (drug effects)
  • Rats
  • Rats, Sprague-Dawley
  • Sugar Alcohols (administration & dosage, toxicity)
  • Weight Loss (drug effects)

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