TY - JOUR
T1 - Hazard identification of pyrogenic synthetic amorphous silica (NM-203) after sub-chronic oral exposure in rat
T2 - A multitarget approach
AU - Tassinari, Roberta
AU - Di Felice, Gabriella
AU - Butteroni, Cinzia
AU - Barletta, Bianca
AU - Corinti, Silvia
AU - Cubadda, Francesco
AU - Aureli, Federica
AU - Raggi, Andrea
AU - Narciso, Laura
AU - Tait, Sabrina
AU - Valeri, Mauro
AU - Martinelli, Andrea
AU - Di Virgilio, Antonio
AU - Pacchierotti, Francesca
AU - Cordelli, Eugenia
AU - Eleuteri, Patrizia
AU - Villani, Paola
AU - Fessard, Valerie
AU - Maranghi, Francesca
N1 - Funding Information:
The study was financially supported by the European Union FP7 Project NANoREG (grant 310584).
Funding Information:
The study was financially supported by the European Union FP7 Project NANoREG (grant 310584 ).
Publisher Copyright:
© 2020 Elsevier Ltd
PY - 2020/3
Y1 - 2020/3
N2 - Food additive E551 consists of synthetic amorphous silica (SAS), comprising agglomerates and aggregates of primary particles in the nanorange (<100 nm), which potential nanospecific risks for humans associated to dietary exposure are not yet completely assessed. In NANoREG project, aim of the study was to identify potential hazards of pyrogenic SAS nanomaterial NM-203 by a 90-day oral toxicity study (OECD test guideline 408). Adult Sprague-Dawley rats of both sexes were orally treated with 0, 2, 5, 10, 20 and 50 mg SAS/kg bw per day; dose levels were selected to be as close as possible to E551 dietary exposure. Several endpoints were investigated, the whole integrative study is presented here along with the results of dispersion characterization, tissue distribution, general toxicity, blood/serum biomarkers, histopathological and immunotoxicity endpoints. No mortality, general toxicity and limited deposition in target tissues were observed. NM-203 affected liver and spleen in both sexes. Proposed NOAEL 5 mg/kg bw per day in male rats for enlarged sinusoids in liver. In female rats, TSH and creatinine levels were affected, proposed LOAEL 2 mg/kg bw per day. Overall, these data provide new insight for a comprehensive risk assessment of SAS exposure by the oral route.
AB - Food additive E551 consists of synthetic amorphous silica (SAS), comprising agglomerates and aggregates of primary particles in the nanorange (<100 nm), which potential nanospecific risks for humans associated to dietary exposure are not yet completely assessed. In NANoREG project, aim of the study was to identify potential hazards of pyrogenic SAS nanomaterial NM-203 by a 90-day oral toxicity study (OECD test guideline 408). Adult Sprague-Dawley rats of both sexes were orally treated with 0, 2, 5, 10, 20 and 50 mg SAS/kg bw per day; dose levels were selected to be as close as possible to E551 dietary exposure. Several endpoints were investigated, the whole integrative study is presented here along with the results of dispersion characterization, tissue distribution, general toxicity, blood/serum biomarkers, histopathological and immunotoxicity endpoints. No mortality, general toxicity and limited deposition in target tissues were observed. NM-203 affected liver and spleen in both sexes. Proposed NOAEL 5 mg/kg bw per day in male rats for enlarged sinusoids in liver. In female rats, TSH and creatinine levels were affected, proposed LOAEL 2 mg/kg bw per day. Overall, these data provide new insight for a comprehensive risk assessment of SAS exposure by the oral route.
KW - Food additive
KW - Hazard characterization
KW - Nanomaterials
KW - No observed adverse effect level
KW - Sex-related effects
KW - Sub-chronic toxicity
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U2 - 10.1016/j.fct.2020.111168
DO - 10.1016/j.fct.2020.111168
M3 - Article
C2 - 32007467
AN - SCOPUS:85079011971
VL - 137
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
SN - 0278-6915
M1 - 111168
ER -