National Toxicology Program

Testing Status of Goldenseal root powder - M980070

CASRN: GOLDENSEALRT

Related: BERBERINE, GOLDEN SEAL, HYDRASTINE

Synonyms/Common Names

• Powdered root of goldenseal

Known Uses

A natural herbal remedy

Nomination Background

Short-Term Toxicity

• 2 weeks (Dosed-Feed)  (C99007)  Completed 
  • Rats: F344/N; Mice: B6C3F1/N
  • Dose: R&M: 0, 1560, 3121, 6250, 12500, 25000 OR 50000 PPM; 5/SEX/SPECIES.
• 13 weeks (Dosed-Feed)  (C99007B)  Completed 
  • Rats: F344/N; Mice: B6C3F1/N
  • Dose: R&M: 0, 3125, 6250, 12500, 25000, OR 50000 PPM; 10/SEX/SPECIES.

Long-Term Carcinogenicity

• 2 years (Dosed-Feed)  (C99007B)  Completed 
  • TR-562 (NIH Number: 10-5903)  (Peer Review Approval 02/25/2009A )
    Toxicology and Carcinogenesis Studies of Goldenseal Root Powder (HYDRASTIS CANADENSIS) in F344/N Rats and B6C3F1 Mice (Feed studies)
  • Rats: F344/N; Mice: B6C3F1/N
  • Carcinogenesis Results
  • Male Rats Clear Evidence 
  • Female Rats Clear Evidence 
  • Male Mice Some Evidence 
  • Female Mice No Evidence 
  • Dose: R&M: 0, 3000, 9000, OR 25, 000 PPM.

Special Studies

• Absorption Disposition Metabolism Elimination (in-vitro)  (S0856)  Completed 
  • Citation: Etheridge AS, Black SR, Patel PR, So J, Mathews JM. An in vitro evaluation of cytochrome P450 inhibition and P-glycoprotein interaction with goldenseal, Ginkgo biloba, grape seed, milk thistle, and ginseng extracts and their constituents. Planta Med. 2007 Jul;73(8):731-41. Epub 2007 Jul 5. PubMed PMID: 17611934.Pubmed Abstract
  • Citation: Final Study Report. Goldensealrt: Interaction of Extracts with Cytochrome P450 Enzymes and P-glycoprotein. Studies of Chemical Disposition in Mammals. 10/14/2002 - 02/28/2006.
  • Human (Cell Lines)
  • Dose: 0, 1, 10, 100 uM..

Genetic Toxicology

• Micronucleus  (A21831)  Completed 
  • Mice: B6C3F1
  • Male Negative 
  • Female Negative 
• Salmonella  (A83314)  Completed 
  •  Negative 

Organ Systems Toxicity

• 6 to 20 GD Conventional Teratology (Dosed-Feed)  (TER98007)  Completed 
  • Citation: FINAL STUDY REPORT DEVELOPMENTAL TOXICITY EVALUTATION FOR GOLDENSEAL ROOT POWDER (HYDRASTIS CANADENSIS) ADMINISTERED IN THE FEED TO SPRAGUE-DAWLWY (CD(r)) RATS ON GESTATIONAL DAYS 6 TO 20
  • Citation: Final Study Report Developmental Toxicity Evaluation for Goldenseal Root Powder (Hydrastis Canadensis) Administered in the Feed to Sprague-Dawley (CD®) Rats on Gestational Days 6 to 20
  • Female Rats: Sprague Dawley
  • Dose: 0, 3125, 6250, 12, 500 OR 18, 400 PPM.
• 6 to 17 GD Conventional Teratology (Dosed-Feed)  (TER99004)  Completed 
  • Citation: Final Study Report Developmental Toxicity Evaluation for Goldenseal (Hydrastis canadensis) root powder Administered in the Feed to Swiss (CD-1®) Mice on Gestational Days 6-17
  • Citation: Final Study Report?Developmental Toxicity Evaluation for Goldenseal (Hydrastis canadensis) root powder Administered in the Feed to Swiss (CD-1®) Mice on Gestational Days 6-17
  • Female Mice: Swiss CD-1
  • Dose: 0, 3125, 12, 500, OR 50, 000 PPM.
• 6 to 20 GD Teratology Pilot Studies (Dosed-Feed)  (TRP98007)  Completed 
  • Rats: Sprague Dawley
  • Dose: 0, 3125, 6250, 12, 500, 25, 000, OR 50, 000 PPM.
• 6 to 17 GD Teratology Pilot Studies (Dosed-Feed)  (TRP99007)  Completed 
  • Female Mice: Swiss CD-1
  • Dose: 0, 3125, 6250, 12, 500, 25, 000 OR 50, 000 PPM.