Select Agents and Toxins Exclusions

Excluded Toxins Modified to be Less Potent or Toxic,
Section 73.3 (e)


TETRODOTOXIN
  • Anhydrotetrodotoxin, a derivative of wild-type tetrodotoxin (effective May 15, 2015)
    Experimental evidence suggests that anhydrotetrodotoxin does not possess sufficient acute toxicity to pose a significant public health threat. Anhydrotetrodotoxin has been shown to have a significantly higher LD50 value than tetrodotoxin in a mouse model [Anhydrotetrodotoxin - LD50 (Oral, mouse) = 16.9 mg/kg compared to tetrodotoxin - LDSO (Oral, mouse) = 0.334 mg/kg]

    Reference(s):
      1. Deguchi T. Structure and activity of tetrodotoxin derivaties. Jpn J Pharmacol. 1967 Jun;17(2):267-78.
      2. Kawasaki H, Nagata T, Kanoh S. An Experience on the Biological Assay of the Toxicity of Imported Fugu (Tetrodon). Food Hygiene Journal. 1973. 14, 186.
      3. Halfmann P, Ebihara H, Marzi A, Hatta Y, Watanabe S, Suresh M, Neumann G, Feldmann H, Kawaoka Y. Replication-deficient ebolavirus as a vaccine candidate. J Virol. 2009 Apr;83(8):3810-5.