TY - JOUR
T1 - Risks for public health related to the presence of tetrodotoxin (TTX) and TTX analogues in marine bivalves and gastropods
AU - EFSA Panel on Contaminants in the Food Chain (CONTAM)
AU - Knutsen, Helle Katrine
AU - Alexander, Jan
AU - Barregård, Lars
AU - Bignami, Margherita
AU - Brüschweiler, Beat
AU - Ceccatelli, Sandra
AU - Cottrill, Bruce
AU - Dinovi, Michael
AU - Edler, Lutz
AU - Grasl-Kraupp, Bettina
AU - Hogstrand, Christer
AU - Hoogenboom, Laurentius (Ron)
AU - Nebbia, Carlo Stefano
AU - Oswald, Isabelle P.
AU - Rose, Martin
AU - Roudot, Alain-Claude
AU - Schwerdtle, Tanja
AU - Vleminckx, Christiane
AU - Vollmer, Günter
AU - Wallace, Heather
AU - Arnich, Nathalie
AU - Benford, Diane
AU - Botana, Luis
AU - Viviani, Barbara
AU - Arcella, Davide
AU - Binaglia, Marco
AU - Horvath, Zsuzsanna
AU - Steinkellner, Hans
AU - van Manen, Mathijs
AU - Petersen, Annette
PY - 2017/4/20
Y1 - 2017/4/20
N2 - 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 0.1 and 25 μg/kg.
AB - 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 0.1 and 25 μg/kg.
KW - tetrodotoxin
KW - marine bivalves
KW - marine gastropods
KW - human health risk
U2 - 10.2903/j.efsa.2017.4752
DO - 10.2903/j.efsa.2017.4752
M3 - Article
SN - 1831-4732
VL - 15
JO - EFSA Journal
JF - EFSA Journal
IS - 4
M1 - e04752
ER -