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Testing Status of Black Cohosh M000058

CASRN: 84776-26-1

Synonyms/Common Names

  • Black snake root
  • Cimicifuga racemosa
  • Remifemin

Short-Term Toxicity

  • 14 days (Gavage)  (C00058B)  Report in Preparation 
    • Rats: Harlan Sprague-Dawley
    • Dose: 38 dams/dose group; 0, 100, 300, or 1000 mg/kg/day.
  • 14-Day  (C00058D)  Completed 
    • Evaluation of Genotoxicity and Epigenetic Modification of Black Cohosh
    • Citation: Seo JE, Guo X, Petibone DM, Shelton SD, Chen Y, Li X, Tryndyak V, Smith-Roe SL, Witt KL, Mei N, Manjanatha MG. Mechanistic evaluation of black cohosh extract-induced genotoxicity in human cells. Toxicol Sci. 2021 Jul 16;182(1):96-106. doi: https://doi.org/10.1093/toxsci/kfab044
    • Human (Cell Lines): TK6 and HepG2 Cells
  • 90 days (Gavage)  (C00058)  Completed 
    • Citation: Mercado-Feliciano M, Cora MC, Witt KL, Granville CA, Hejtmancik MR, Fomby L, Knostman KA, Ryan MJ, Newbold R, Smith C, Foster PM, Vallant MK, Stout MD. Anethanolic extract of black cohosh causes hematological changes but not estrogenic effects in female rodents. Toxicol Appl Pharmacol. 2012 Sep 1;263(2):138-47. doi:10.1016/j.taap.2012.05.022. Epub 2012 Jun 9.Pubmed Abstract
    • Mice: B6C3F1
    • Dose: Females: 0, 62.5, 125, 250, 500 or 1000 mg/kg.
  • 90 days (Gavage)  (C00058C)  Completed 
    • Subchronic Macrocytic Non-regenerative Anemia (megaloblastic disorder)
    • Mice: B6C3F1
    • Dose: 0, 1000 mg/kg; 32/per dose.
  • 13 weeks (Gavage)  (C20112)  Completed 
    • Citation: Mercado-Feliciano M, Cora MC, Witt KL, Granville CA, Hejtmancik MR, Fomby L, Knostman KA, Ryan MJ, Newbold R, Smith C, Foster PM, Vallant MK, Stout MD. Anethanolic extract of black cohosh causes hematological changes but not estrogenic effects in female rodents. Toxicol Appl Pharmacol. 2012 Sep 1;263(2):138-47. doi:10.1016/j.taap.2012.05.022. Epub 2012 Jun 9.Pubmed Abstract
    • Rats: Wistar Han
    • Dose: 0, 15, 125, 250, 500, or 1000 mg/kg.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C00058B)  Report in Preparation 
    • Rats: Harlan Sprague-Dawley; Mice: B6C3F1
    • Dose: Rats: 0, 75, 250, or 750 mg/kg/day; 50/sex/dose Female mice: 0, 30, 100, 300, or 1000 mg/kg/day; 70/dose.

Genetic Toxicology

  • Micronucleus  (G00058)  Completed 
    • Citation: Mercado-Feliciano M, Cora MC, Witt KL, Granville CA, Hejtmancik MR, Fomby L, Knostman KA, Ryan MJ, Newbold R, Smith C, Foster PM, Vallant MK, Stout MD. Anethanolic extract of black cohosh causes hematological changes but not estrogenic effects in female rodents. Toxicol Appl Pharmacol. 2012 Sep 1;263(2):138-47. doi:10.1016/j.taap.2012.05.022. Epub 2012 Jun 9.Pubmed Abstract
    • Rats: Wistar Han
    • Female Positive 
  • Micronucleus  (G00058B)  Completed 
    • Citation: Mercado-Feliciano M, Cora MC, Witt KL, Granville CA, Hejtmancik MR, Fomby L, Knostman KA, Ryan MJ, Newbold R, Smith C, Foster PM, Vallant MK, Stout MD. Anethanolic extract of black cohosh causes hematological changes but not estrogenic effects in female rodents. Toxicol Appl Pharmacol. 2012 Sep 1;263(2):138-47. doi:10.1016/j.taap.2012.05.022. Epub 2012 Jun 9.Pubmed Abstract
    • Mice: B6C3F1
    • Female Positive 
  • Micronucleus  (G00058C)  Completed 
    • Mice: B6C3F1
    • Female Positive 
  • 365 days Micronucleus  (G00058E)  Completed 
    • Mice: B6C3F1
    • Female Positive 
  • 24 hours Micronucleus (in-vitro)  (G00058F)  Completed 
    • Lot/Batch: 3012782
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058G)  Completed 
    • Lot/Batch: 3012782 (2 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058H)  Completed 
    • Lot/Batch: 3012782 (3 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058I)  Completed 
    • Lot/Batch: 3012782 (4 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058J)  Completed 
    • Lot/Batch: 3012782 (5 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058K)  Completed 
    • Lot/Batch: 3012782 (6 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058L)  Completed 
    • Lot/Batch: 3012782 (7 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058M)  Completed 
    • Lot/Batch: 3012782 (8 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058N)  Completed 
    • Lot/Batch: 3012782 (9 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058O)  Completed 
    • Lot/Batch: 3012782 (10 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058P)  Completed 
    • Lot/Batch: 3012782 (11 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058Q)  Completed 
    • Lot/Batch: 3012782 (12 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058R)  Completed 
    • Lot/Batch: 3012782 (13 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058S)  Completed 
    • Lot/Batch: 3012782 (14 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058T)  Completed 
    • Lot/Batch: 3012782 (15 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058U)  Completed 
    • Lot/Batch: 3012782 (16 of 16)
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058_D1-01)  Completed 
    • Extract Serial Extraction Whole Extract DMSO
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058_EA2-01)  Completed 
    • Extract Serial Extraction 2: Ethyl Acetate Extract
    • Human (Cell Lines)
  • 24 hours Micronucleus (in-vitro)  (G00058_M4-01)  Completed 
    • Extract Serial Extraction 4: Methanol Extract
    • Human (Cell Lines)
  • Salmonella  (A13815)  Completed 
    •  Negative 
  • Salmonella  (G00058D)  Completed 
    •  Equivocal 
  • 48 hours Salmonella (in-vitro)  (G00058V)  Completed 
    • 48 hours Salmonella (in-vitro)  (G00058W)  Completed 
      • 48 hours Salmonella (in-vitro)  (G00058X)  Completed 
        • 48 hours Salmonella (in-vitro)  (G00058Y)  Completed 
          • 48 hours Salmonella (in-vitro)  (G00058Z)  Completed 

            Organ Systems Toxicity

            • Continuous Breeding (Gavage)  (R00058)  Report in Preparation 
              • Dose range finding
              • Male and Female Rats: Harlan Sprague-Dawley
              • Dose: 0, 100, 300, or 1000 mg/kg.
            • Continuous Breeding (Gavage)  (R00058B)  Completed 
              • Male and Female Rats: Harlan Sprague-Dawley
              • Dose: 0, 250, 500, or 100 mg/kg/day.
            • 28 days Immunotoxicity (Gavage)  (I00058)  Completed 
              • Citation: Smith MJ, Germolec DR, Frawley RP, White KL Jr. Immunomodulatory effects of black cohosh (Actaea racemosa) extract in female B6C3F1/N mice. Toxicology. 2013 Jun 7;308:146-57. doi: 10.1016/j.tox.2013.03.017. Epub 2013 Apr 6.Pubmed Abstract
              • Female Mice: B6C3F1
              • Dose: 0, 62.5, 125, 250, 500 or 1000 mg/kg.

            Toxicogenomics

            • 13 weeks Microarray Analysis (Gavage)  (T00058)  Completed 
              • Subchronic Macrocytic Non-regenerative Anemia (megaloblastic disorder)
              • Mice: B6C3F1
              • Dose: 0 or 1000 mg/kg; 32 mice/group.