Open AccessRisks for public health related to the presence of tetrodotoxin ( TTX ) and TTX analogues in marine bivalves and gastropods
Author(s) -
Knutsen Helle Katrine,
Alexander Jan,
Barregård Lars,
Bignami Margherita,
Brüschweiler Beat,
Ceccatelli Sandra,
Cottrill Bruce,
Dinovi Michael,
Edler Lutz,
GraslKraupp Bettina,
Hogstrand Christer,
Hoogenboom Laurentius Ron,
Nebbia Carlo Stefano,
Oswald Isabelle P.,
Rose Martin,
Roudot AlainClaude,
Schwerdtle Tanja,
Vleminckx Christiane,
Vollmer Günter,
Wallace Heather,
Arnich Nathalie,
Benford Diane,
Botana Luis,
Viviani Barbara,
Arcella Davide,
Binaglia Marco,
Horvath Zsuzsanna,
Steinkellner Hans,
Manen Mathijs,
Petersen Annette
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.4752
Subject(s) - tetrodotoxin , european commission , toxicology , biology , fishery , ecotoxicology , chemistry , zoology , european union , endocrinology , business , economic policy
Tetrodotoxin (TTX) and its analogues are produced by marine bacteria and have been detected in marine bivalves and gastropods from European waters. The European Commission asked EFSA for a scientific opinion on the risks to public health related to the presence of TTX and TTX analogues in marine bivalves and gastropods. The Panel on Contaminants in the Food Chain reviewed the available literature but did not find support for the minimum lethal dose for humans of 2 mg, mentioned in various reviews. Some human case reports describe serious effects at a dose of 0.2 mg, corresponding to 4 μg/kg body weight (bw). However, the uncertainties on the actual exposure in the studies preclude their use for derivation of an acute reference dose (ARfD). Instead, a group ARfD of 0.25 μg/kg bw, applying to TTX and its analogues, was derived based on a TTX dose of 25 μg/kg bw at which no apathy was observed in an acute oral study with mice, applying a standard uncertainty factor of 100. Estimated relative potencies for analogues are lower than that of TTX but are associated with a high degree of uncertainty. Based on the occurrence data submitted to EFSA and reported consumption days only, average and P95 exposures of 0.00–0.09 and 0.00–0.03 μg/kg bw, respectively, were calculated. Using a large portion size of 400 g bivalves and P95 occurrence levels of TTX, with exception of oysters, the exposure was below the group ARfD in all consumer groups. A concentration below 44 μg TTX equivalents/kg shellfish meat, based on a large portion size of 400 g, was considered not to result in adverse effects in humans. Liquid chromatography with tandem mass spectroscopy (LC–MS/MS) methods are the most suitable for identification and quantification of TTX and its analogues, with LOQs between 1 and 25 μg/kg.