Test Methods

Selected Chinese herbal medicines

Medicine NameClinical DoseAnimal DoseDevelopmental ToxicitySpecies
Three-wing-nut0.5-1.5g(8-25mg/kg)stillbirth, dysosteogenesismice
Leech1.5~3g(25-50mg/kg)fetal resorption, growth retardation, still birth, tongue, palate, limb defectsmice
Trichosanthes Root9-15g(150-250mg/kg)stillbirth, exencephalymice
Figwort flower1.5-20g(20-300mg/kg)low birth weight, small for gestational agehuman
Milkvetch Root9-30g(150-500mg/kg)slightly skeleton defectrat
White Peony Root6-15g(100-250mg/kg)low fetal and placental weightrat
Baical Skullcap Root3-10g(50-150mg/kg)no malformation & adverse outcomesrat
Sanchi3-10g(50-150mg/kg)no malformation& adverse outcomesmice
Safflower0.5-2g(8-30mg/kg)no malformation& adverse outcomesrat
Salvia root6-15g(100-250mg/kg)no malformation& adverse outcomesrat
Selection of test Chinese herbal medicines for this evaluation study was based on the guidelines of European Centre for the Validation of Alternative Methods (ECVAM, Brown NA., 2002). Only well characterized Chinese herbal medicines with sufficiently high quality in vivo developmental toxicity data or teratogenicity reports from human and/or animals were selected. The initial part of the study was to select 15 candidate test medicines for the study. Embryo toxicity classifications of the selected test medicines were defined according to the available teratogenic effects in vivo in offspring of at least one or more mammalian species (Curren et al., 1995). The candidates were divided into 3 categories. Class 1, non-embryotoxic medicines included the medicines of no developmentally toxic, which are usually most frequently used in clinical practices during pregnancy and have no developmental toxicity at maternally exposures, nor any minor embryo/fetal toxicity which could not be separated from maternal toxicity. Class 2, weakly embryotoxic medicines included the medicines of intermediate embryotoxicity, which are also commonly used in clinical practice but only minor fetal weight or skeleton changes have been identified. Class 3, strongly embryotoxic medicines included the medicines of developmentally toxic induced multiple developmental effects, such as fetal/neonatal death, congenital malformations and/or severe growth retardation. At least 3 out of 5 listed test medicines for each embryotoxic potential were evaluated and tested. References: Brown N, Spielmann H, Bechter R, Flint OP, Freeman SJ, Jelinek RJ, Koch E, Nau H, Newall DR, Palmer AK, Renault JY, Repetto M, Vogel R, Wiger R. 1995. Screening chemicals for reproductive toxicity: The current alternatives. The report and recommendations of an ECVAM/ETS workshop (ECVAM workshop 12). Altern Lab Anim 23: 868-882 Curren RD, Southee JA, Spielmann H, Liebesch M, Fentem J, Balls M. 1995. The role of prevalidation in the development, validation and acceptance of alternative methods. Altern Lab Anim 23: 211-217