Open AccessAppropriateness to set a group health based guidance value for nivalenol and its modified forms
Author(s) -
Knutsen Helle Katrine,
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,
Petersen Annette,
Rose Martin,
Roudot AlainClaude,
Schwerdtle Tanja,
Vleminckx Christiane,
Vollmer Günter,
Wallace Heather,
Dall'Asta Chiara,
Gutleb Arno C,
Metzler Manfred,
ParentMassin Dominique,
Binaglia Marco,
Steinkellner Hans,
Alexander Jan
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.2017.4751
Subject(s) - tolerable daily intake , metabolite , mink , toxicology , chemistry , physiology , body weight , medicine , biology , biochemistry , ecology
The EFSA Panel on Contaminants in the Food Chain ( CONTAM ) reviewed new studies on nivalenol since the previous opinion on nivalenol published in 2013, but as no new relevant data were identified the tolerable daily intake ( TDI ) for nivalenol ( NIV ) of 1.2 μg/kg body weight (bw) established on bases of immuno‐ and haematotoxicity in rats was retained. An acute reference dose ( AR fD) of 14 μg/kg bw was established based on acute emetic events in mink. The only phase I metabolite of NIV identified is de‐epoxy‐nivalenol ( DE ‐ NIV ) and the only phase II metabolite is nivalenol‐3‐glucoside ( NIV 3Glc). DE ‐ NIV is devoid of toxic activity and was thus not further considered. NIV 3Glc can occur in cereals amounting up to about 50% of NIV . There are no toxicity data on NIV 3Glc, but as it can be assumed that it is hydrolysed to NIV in the intestinal tract it should be included in a group TDI and in a group AR fD with NIV . The uncertainty associated with the present assessment is considered as high and it would rather overestimate than underestimate any risk.