PMID- 16634078
OWN - NLM
STAT- MEDLINE
DCOM- 20070612
LR  - 20131121
IS  - 1542-9733 (Print)
IS  - 1542-9733 (Linking)
VI  - 77
IP  - 3
DP  - 2006 Jun
TI  - Developmental toxicity evaluation of berberine in rats and mice.
PG  - 195-206
AB  - BACKGROUND: Berberine, a plant alkaloid, is found in some herbal teas and 
      health-related products. It is a component of goldenseal, an herbal supplement. 
      Berberine chloride dihydrate (BCD) was evaluated for developmental toxicity in 
      rats and mice. METHODS: Berberine chloride dihydrate was administered in the feed 
      to timed-mated Sprague-Dawley (CD) rats (0, 3,625, 7,250, or 14,500 ppm; on 
      gestational days [GD] 6-20), and Swiss Albino (CD-1) mice (0, 3,500, 5,250, or 
      7,000 ppm; on GD 6-17). Ingested doses were 0, 282, 531, and 1,313 mg/kg/day 
      (rats) and 0, 569, 841, and 1,155 mg/kg/day (mice). RESULTS: There were no 
      maternal deaths. The rat maternal lowest observed adverse effect level (LOAEL), 
      based on reduced maternal weight gain, was 7,250 ppm. The rat developmental 
      toxicity LOAEL, based on reduced fetal body weight per litter, was 14,500 ppm. In 
      the mouse study, equivocal maternal and developmental toxicity LOAELs were 5,250 
      ppm. Due to scattering of feed in the high dose groups, a gavage study at 1,000 
      mg/kg/day was conducted in both species. CONCLUSIONS: In rats, maternal, but not 
      fetal adverse effects were noted. The maternal toxicity LOAEL remained at 7,250 
      ppm (531 mg/kg/day) based on the feed study and the developmental toxicity NOAEL 
      was raised to 1,000 mg/kg/day BCD based on the gavage study. In the mouse, 33% of 
      the treated females died. Surviving animals had increased relative water intake, 
      and average fetal body weight per litter decreased 5-6% with no change in live 
      litter size. The maternal toxicity LOAEL remained at 5,250 ppm (841 mg/kg/day) 
      BCD, based on increased water consumption. The developmental toxicity LOAEL was 
      raised to 1,000 mg/kg/day BCD based on decreased fetal body weight.
FAU - Jahnke, Gloria D
AU  - Jahnke GD
AD  - Sciences International Inc., Research Triangle Park, North Carolina 27709, USA. 
      Janke@niehs.nih.gov
FAU - Price, Catherine J
AU  - Price CJ
FAU - Marr, Melissa C
AU  - Marr MC
FAU - Myers, Christina B
AU  - Myers CB
FAU - George, Julia D
AU  - George JD
LA  - eng
GR  - N01-ES-65405/ES/NIEHS NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - Birth Defects Res B Dev Reprod Toxicol
JT  - Birth defects research. Part B, Developmental and reproductive toxicology
JID - 101155115
RN  - 0I8Y3P32UF (Berberine)
SB  - IM
MH  - Animals
MH  - Animals, Outbred Strains
MH  - Berberine/*toxicity
MH  - Embryonic Development/*drug effects
MH  - Feeding Behavior
MH  - Female
MH  - Fetal Weight/drug effects
MH  - Fetus/drug effects/embryology
MH  - Mice
MH  - No-Observed-Adverse-Effect Level
MH  - Pregnancy
MH  - Rats
EDAT- 2006/04/25 09:00
MHDA- 2007/06/15 09:00
CRDT- 2006/04/25 09:00
PHST- 2006/04/25 09:00 [pubmed]
PHST- 2007/06/15 09:00 [medline]
PHST- 2006/04/25 09:00 [entrez]
AID - 10.1002/bdrb.20075 [doi]
PST - ppublish
SO  - Birth Defects Res B Dev Reprod Toxicol. 2006 Jun;77(3):195-206. doi: 
      10.1002/bdrb.20075.