• Journal of Food Hygiene and Safety
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• v.39 no.5
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• pp.404-411
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• 2024

Paralytic Shellfish Poisoning (PSP) occurs when humans consume shellfish contaminated with saxitoxin (STX) and its derivatives. It causes symptoms ranging from numbness and nausea to severe muscle paralysis and respiratory failure. Toxic equivalency factors (TEFs) are used to standardize the toxic effects of various PSP toxins for risk assessment. Traditional detection methods, such as mouse bioassays, have been used to set the TEFs, but ethical concerns over in vivo studies have shifted the focus toward analytical methods, such as high-performance liquid chromatography. However, in vivo data are essential for establishing TEFs, particularly for emerging marine biotoxins. This study employed a three-level response surface pathway (RSP) design, which reduced the number of animals used to evaluate the median lethal dose (LD₅₀) of STX and its derivatives. The LD₅₀ and TEF values for STX dihydrochloride, neosaxitoxin, decarbamoylsaxitoxin, gonyautoxins 1 & 4 (GTX1&4), GTX2&3, and dcGTX2&3 were 451.3 (1.00), 306.5 (1.47), 860.9 (0.52), 644.5 (0.70), 915.3 (0.49), and 2409.3 (0.19) ㎍/kg, respectively. These TEFs closely aligned with the WHO recommendations and prior oral LD₅₀ values, with Pearson correlation coefficients of 0.969 and 0.994, respectively. This study highlights the need for accurate TEF assignments for PSP toxins and new marine biotoxins, demonstrating that the three-level RSP design balances ethical concerns and provides reliable toxicity data.