Nonclinical toxicology studies with sodium taurodeoxycholate: acute and subacute toxicity in dogs

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Nonclinical toxicology studies with sodium taurodeoxycholate: acute and subacute toxicity in dogs
H J Choi; J W Yun; Y H Kim; E Kwon; M K Hyon; J Y Kim; J H Che; J S Park; Hyoung-Chin Kim; W H Kim; S Y Seong; B C Kang
Bibliographic Citation
Drug and Chemical Toxicology, vol. 44, no. 2, pp. 161-169
Publication Year
Sodium taurodeoxycholate (TDCA) has been investigated for various inflammatory disorders such as sepsis. We recently evaluated nonclinical safety profile of TDCA using rats infused intravenously. As a series of preclinical safety investigations, we further conducted toxicity studies with TDCA delivered to dogs via intravenous administration under Good Laboratory Practice regulation in this study. In dose range-finding study (dose escalation study), dogs given with TDCA at a dose of 150 mg/kg showed marked changes in clinical signs, hematology, and serum biochemistry. And biochemical markers of liver damage and local skin lesions were observed following intravenous infusion of 100mg/kg TDCA, suggesting that 100mg/kg was chosen as the highest dose of TDCA for 4-week repeated-dose toxicity study using dogs. Despite no treatment-related significant changes in body weight, food consumption, ophthalmoscopy, and urinalysis, skin lesions were observed at the injection site of animals administered with higher than 50mg/kg of TDCA along with biochemical and histopathological changes associated with liver injury. However, most of off-target effects were found to be reversible since these were recovered after stopping TDCA infusion. These findings indicate that the no-observed-adverse-effect-level (NOAEL) for TDCA in dogs was considered to be 5mg/kg/d. Taken together, our results provide important toxicological profiles regarding the safe dose of TDCA for drug development or clinical application.
TaurodeoxycholateAcute toxicityBile acidDogSepsisSubacute toxicity
T&F (Taylor & Francis)
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Ochang Branch Institute > Division of Bioinfrastructure > 1. Journal Articles
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