Long-term toxicity study of 13-methyltetradecanoic acid in Beagle dogs

OBJECTIVE To monitor toxic reactions and seriousness due to long-term accumulation of drug in the body of Beagle dogs after twelve-week oral administration of 13-methyltetradecanoic acid(13-MTD),for reference in clinical trials.METHODS Twelve Beagle dogs were randomly divided into 3 groups of 4 with 2 in each gender.The dogs in two test groups were orally administered with 13-MTD at 0.4 g·kg-1 and 0.8 g·kg-1 daily for twelve weeks,respectively.RESULTS No significant anomalies were found in the animals in test groups,comparing to those in the control group,including electrocardiogram, hemogram,hepatorenal functions,routine examination of urine,and pathological biopsy.Another 2-week observation after the end of treatment also showed no delayed abnormal reactions.CONCLUSION Oral administration of 13-MTD 0.8 g·kg-1(40 times clinically recommended dose) daily for twelve weeks in beagle dogs was safe.