Final Study Report on the Developmental Toxicity Research Evaluation for Berberine Chloride Dihydrate (CAS No. 5956-60-5) Administered by Gavage to Swiss (CD (Trade Name)) Mice on Gestational Days 6 through 16

摘要

The National Toxicology Program (NTP) develops, evaluates, and disseminates scientific information about potentially toxic and hazardous chemicals. This knowledge is used for protecting the health of the American people and for the primary prevention of disease. Berberine, and its salts (e.g. berberine chloride dehydrate, BCD) are yellow crystalline materials that are used in Chinese herbal medicine, and in the United States as a dietary supplement. In addition, berberine is a component of goldenseal, another popular herbal dietary supplement. The study was performed as a follow-up research study to a previously conducted developmental toxicity evaluation of berberine chloride dehydrate, administered in the feed (0, 3500, 5250, or 7000 ppm) to Swiss (CD-1(Trade Name)) mice on gestational days (gd) 6 through 17 (NTP, 2001a). The present study sought to further define the maternal and developmental effects of 1000 mg/kg/day BCD when administered by gavage (a more accurate oral route of exposure) on gd 6 through 16. Administration by gavage was also chosen to eliminate changes in feel/water consumption observed in the previous study that may have been due to altered palatability of the dosed feed.