Select Agents and Toxins Exclusions:
Excluded Toxins Modified to be Less Potent or Toxic, Section 73.3 (e)
- 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 – LD50 (Oral, mouse) = 0.334 mg/kg]Reference(s):
- Deguchi T. Structure and activity of tetrodotoxin derivatiesexternal icon. Jpn J Pharmacol. 1967 Jun;17(2):267-78.
- 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.
- Halfmann P, Ebihara H, Marzi A, Hatta Y, Watanabe S, Suresh M, Neumann G, Feldmann H, Kawaoka Y. Replication-deficient ebolavirus as a vaccine candidateexternal icon. J Virol. 2009 Apr;83(8):3810-5.
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Content source: Division of Regulatory Science and Compliance