Publications by authors named "A Sacchi"

667 Publications

An Extract from Cell Cultures Works as an Anti-Stress Ingredient for the Skin.

Antioxidants (Basel) 2021 Mar 25;10(4). Epub 2021 Mar 25.

Arterra Bioscience SpA, Via Benedetto Brin 69, 80142 Napoli, Italy.

Psychological stress activates catecholamine production, determines oxidation processes, and alters the lipid barrier functions in the skin. Scientific evidence associated with the detoxifying effect of fruits and vegetables, the growing awareness of the long-term issues related to the use of chemical-filled cosmetics, the aging of the population, and the increase in living standards are the factors responsible for the growth of food-derived ingredients in the cosmetics market. A cell suspension culture extract (FcHEx) was tested in vitro (on keratinocytes cells) and in vivo to evaluate its ability to manage the stress-hormone-induced damage in skin. The FcHEx reduced the epinephrine (-43% and -24% at the concentrations of 0.002% and 0.006%, respectively), interleukin 6 (-38% and -36% at the concentrations of 0.002% and 0.006%, respectively), lipid peroxide (-25%), and protein carbonylation (-50%) productions; FcHEx also induced ceramide synthesis (+150%) and ameliorated the lipid barrier performance. The in vivo experiments confirmed the in vitro test results. Transepidermal water loss (TEWL; -12.2%), sebum flow (-46.6% after two weeks and -73.8% after four weeks; on the forehead -56.4% after two weeks and -80.1% after four weeks), and skin lightness (+1.9% after two weeks and +2.7% after four weeks) defined the extract's effects on the skin barrier. The extract of the cell suspension cultures reduced the transepidermal water loss, the sebum production, the desquamation, and facial skin turning to a pale color from acute stress, suggesting its role as an ingredient to fight the signs of psychological stress in the skin.
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http://dx.doi.org/10.3390/antiox10040515DOI Listing
March 2021

Elevated P-Selectin in Severe Covid-19: Considerations for Therapeutic Options.

Mediterr J Hematol Infect Dis 2021 1;13(1):e2021016. Epub 2021 Mar 1.

National Institute for Infectious Diseases, "Lazzaro Spallanzani" Rome, Italy.

Background: Coronavirus disease 2019 (COVID-19) is mainly a respiratory tract disease and acute respiratory failure with diffuse microvascular pulmonary thrombosis are critical aspects of the morbidity and mortality of this new syndrome.

Purpose: The aim of our study was to investigate, in severe COVID-19 hospitalized patients, the P-selectin plasma concentration as a biomarker of endothelial dysfunction and platelet activation.

Methods: 46 patients with severe or critical SARS-CoV-2 infection were included in the study. Age-matched patients then were divided in those requiring admission to the intensive care unit (ICU, ICU cases) vs those not requiring ICU hospitalization (non-ICU cases). Blood samples of severe COVID-19 patients were collected at the time of hospital admission. The quantification of soluble P-selectin was performed by ELI, assay.

Results: Our study showed a higher P-selectin plasma concentration in patients with Covid-19, regardless of ICU admission, compared to the normal reference values and compared to ten contextually sampled healthy donors (HD); (COVID-19): median 65.2 (IQRs: 45.1-81.1) vs. HD: 40.3 (IQRs: 24.3-48.7), p=0023. Moreover, results showed a significant reduction of P-sele din after platelets removal in HD, in contrast, both ICU and non-ICU COVID-19 patients showed similar high levels of P-selectin with and without platelets.

Conclusion: Elevation of P-selectin suggests a central role of platelet endothelium interaction as part of the multifaced pathogenic mechanism of COVID-19 leading to the local activation of hemostatic system forming pulmonary thrombi. Further work is necessary to determine the therapeutic role of antiplatelets agents or of the anti P-selectin antibody Crizanlizumab.
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http://dx.doi.org/10.4084/MJHID.2021.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938922PMC
March 2021

Setting of import tolerance for azoxystrobin in sugar beet roots.

EFSA J 2021 Feb 18;19(2):e06401. Epub 2021 Feb 18.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Austria to set an import tolerance for the active substance azoxystrobin in sugar beet roots. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for sugar beet roots. However, robust processing factors for Annex VI in view of monitoring of residues in processed commodities could not be derived. Adequate analytical methods for enforcement are available to control the residues of azoxystrobin in plant and animal matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of azoxystrobin according to the reported agricultural practice is unlikely to present a risk to consumer health.
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http://dx.doi.org/10.2903/j.efsa.2021.6401DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7890444PMC
February 2021

Modification of the existing maximum residue levels for acibenzolar-S-methyl in beans with pods and peas with pods.

EFSA J 2021 Feb 26;19(2):e06430. Epub 2021 Feb 26.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to amend the residue definition for risk assessment and to modify the existing maximum residue levels (MRLs) for the active substance acibenzolar-S-methyl in beans (with pods) and peas (with pods). The toxicological data submitted in support of this MRL application were found to be sufficient to conclude that the plant metabolite 4-OH acibenzolar acid is not genotoxic in vitro, however lacking investigation of the general toxicity, a definitive conclusion cannot be derived whether 4-OH acibenzolar acid (free and conjugated) should be included or excluded from the residue definition for risk assessment for all commodities belonging to the groups of leafy crops and pulses/oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals on the basis of the current residue definition (sum of acibenzolar-S-methyl and acibenzolar acid (free and conjugated), expressed as acibenzolar-S-methyl) for the intended uses on lettuces and salad plants, beans (with pods) and peas (with pods). The available residue trials are sufficient to derive MRL proposals of 1 mg/kg for beans with pods and peas with pods. The submitted information did not provide evidence that the existing MRL has to be changed for the intended uses on lettuces and other salad plants. For herbs and edible flowers, data gaps were identified which precluded the derivation of MRL proposals. The consumer risk assessment for the current residue definition did not identify an unacceptable risk for consumers. The indicative exposure calculations performed for the metabolite 4-OH acibenzolar indicate that exposure to this metabolite is lower than the exposure to acibenzolar-S-methyl and acibenzolar acid (free and conjugated). However, considering the data gaps identified, a definitive conclusion cannot be derived by EFSA on the risk for consumers related to the intake of residues of 4-OH acibenzolar acid. The reliable end points appropriate for use in regulatory risk assessment are presented.
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http://dx.doi.org/10.2903/j.efsa.2021.6430DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7908853PMC
February 2021

Molecular and serological detection of arthropod-borne pathogens in carnivorous birds from Brazil.

Vet Parasitol Reg Stud Reports 2021 Jan 23;23:100539. Epub 2021 Jan 23.

Laboratório de Imunoparasitologia, Departamento de Patologia, Reproducao e Saude Unica, Veterinária, Faculdade de Ciências Agrárias e Veterinárias/Universidade Estadual Paulista, UNESP, Jaboticabal, São Paulo, Brazil. Electronic address:

Rickettsiales, Haemosporida and Rhizobiales agents can cause diseases that affect various animal species, including humans. Due to predation behaviour, carnivorous birds may play an important role in spreading these etiological agentes across geographically distant areas, specially if they are migratory. The aim of this study was to investigate the occurrence and to access the phylogenetic relations among Anaplasmataceae (Ehrlichia, Anaplasma, Neorickettsia), Bartonellaceae (Bartonella spp.), and Haemosporida (Plasmodium, Haemoproteus and Leucocytozoon) agents in blood samples from 121 carnivorous birds sampled in the states of São Paulo and Rio de Janeiro, Brazil. Inclusions resembling hemoparasites were not observed in Giemsa-stained preparations. While three animals were seropositive for E. chaffeensis (3.41% [3/88]; 95% CI:1.17-9.55%), five showed antibodies to A. phagocytophilum (5.68% [5/88]; 95% CI: 2.45-12.62%). Despite the detection of rrs gene fragments closely related to E. chaffeensis (4.13% [5/121]; 95% CI: 1.78-9.31%), no positivity was observed in the qPCR based on the genes vlpt for the organism. Similarly, 12 (9.91% [12/121]; 95% CI: 5.76-16.74%) samples were positive in the qPCR for Anaplasma spp. based on groEL gene, but negative in the qPCR for A. phagocytophilum based on msp-2 gene. Three samples were positive in the nPCR for E. canis based on rrs gene. Three samples were positive for Haemoproteus spp. and one for Plasmodium spp. in the nPCR based on cytB gene. Four birds (3.3% [4/121]; 95% CI: 1.29-8.19%) presented co-positivity by Ehrlichia sp. and Anaplasma sp. in molecular assays. One (0.82% [1/121]; 95% CI:0.15-4.53%) bird showed to be seropositive for E. chaffeensis and and positive in PCR for Haemoproteus sp. All birds were negative in the qPCR assay for Bartonella spp. (nuoG). The present work showed the occurrence of Anaplasmataceae agents and hemosporidians in carnivorous birds from southeastern Brazil. The role of these animals in the dispersion of Anaplasmataceae agents should be further investigated.
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http://dx.doi.org/10.1016/j.vprsr.2021.100539DOI Listing
January 2021

Risk and predictive factors of prolonged viral RNA shedding in upper respiratory specimens in a large cohort of COVID-19 patients admitted to an Italian reference hospital.

Authors:
Annalisa Mondi Patrizia Lorenzini Concetta Castilletti Roberta Gagliardini Eleonora Lalle Angela Corpolongo Maria Beatrice Valli Fabrizio Taglietti Stefania Cicalini Laura Loiacono Francesco Di Gennaro Gianpiero D'Offizi Fabrizio Palmieri Emanuele Nicastri Chiara Agrati Nicola Petrosillo Giuseppe Ippolito Francesco Vaia Enrico Girardi Maria Rosaria Capobianchi Andrea Antinori Sara Zito Maria Alessandra Abbonizio Amina Abdeddaim Elisabetta Agostini Chiara Agrati Fabrizio Albarello Gioia Amadei Alessandra Amendola Andrea Antinori Maria Assunta Antonica Mario Antonini Tommaso Ascoli Bartoli Francesco Baldini Raffaella Barbaro Barbara Bartolini Rita Bellagamba Martina Benigni Nazario Bevilacqua Gianluigi Biava Michele Bibas Licia Bordi Veronica Bordoni Evangelo Boumis Marta Branca Rosanna Buonomo Donatella Busso Marta Camici Paolo Campioni Flaminia Canichella Maria Rosaria Capobianchi Alessandro Capone Cinzia Caporale Emanuela Caraffa Ilaria Caravella Fabrizio Carletti Concetta Castilletti Adriana Cataldo Stefano Cerilli Carlotta Cerva Roberta Chiappini Pierangelo Chinello Maria Assunta Cianfarani Carmine Ciaralli Claudia Cimaglia Nicola Cinicola Veronica Ciotti Stefania Cicalini Francesca Colavita Angela Corpolongo Massimo Cristofaro Salvatore Curiale Alessandra D'Abramo Cristina Dantimi Alessia De Angelis Giada De Angelis Maria Grazia De Palo Federico De Zottis Virginia Di Bari Rachele Di Lorenzo Federica Di Stefano Gianpiero D'Offizi Davide Donno Francesca Evangelista Francesca Faraglia Anna Farina Federica Ferraro Lorena Fiorentini Andrea Frustaci Matteo Fusetti Vincenzo Galati Roberta Gagliardini Paola Gallì Gabriele Garotto Ilaria Gaviano Saba Gebremeskel Tekle Maria Letizia Giancola Filippo Giansante Emanuela Giombini Guido Granata Maria Cristina Greci Elisabetta Grilli Susanna Grisetti Gina Gualano Fabio Iacomi Marta Iaconi Giuseppina Iannicelli Carlo Inversi Giuseppe Ippolito Eleonora Lalle Maria Elena Lamanna Simone Lanini Daniele Lapa Luciana Lepore Raffaella Libertone Raffaella Lionetti Giuseppina Liuzzi Laura Loiacono Andrea Lucia Franco Lufrani Manuela Macchione Gaetano Maffongelli Alessandra Marani Luisa Marchioni Andrea Mariano Maria Cristina Marini Micaela Maritti Alessandra Mastrobattista Ilaria Mastrorosa Giulia Matusali Valentina Mazzotta Paola Mencarini Silvia Meschi Francesco Messina Sibiana Micarelli Giulia Mogavero Annalisa Mondi Marzia Montalbano Chiara Montaldo Silvia Mosti Silvia Murachelli Maria Musso Michela Nardi Assunta Navarra Emanuele Nicastri Martina Nocioni Pasquale Noto Roberto Noto Alessandra Oliva Ilaria Onnis Sandrine Ottou Claudia Palazzolo Emanuele Pallini Fabrizio Palmieri Giulio Palombi Carlo Pareo Virgilio Passeri Federico Pelliccioni Giovanna Penna Antonella Petrecchia Ada Petrone Nicola Petrosillo Elisa Pianura Carmela Pinnetti Maria Pisciotta Pierluca Piselli Silvia Pittalis Agostina Pontarelli Costanza Proietti Vincenzo Puro Paolo Migliorisi Ramazzini Alessia Rianda Gabriele Rinonapoli Silvia Rosati Dorotea Rubino Martina Rueca Alberto Ruggeri Alessandra Sacchi Alessandro Sampaolesi Francesco Sanasi Carmen Santagata Alessandra Scarabello Silvana Scarcia Vincenzo Schininà Paola Scognamiglio Laura Scorzolini Giulia Stazi Giacomo Strano Fabrizio Taglietti Chiara Taibi Giorgia Taloni Tetaj Nardi Roberto Tonnarini Simone Topino Martina Tozzi Francesco Vaia Francesco Vairo Maria Beatrice Valli Alessandra Vergori Laura Vincenzi Ubaldo Visco-Comandini Serena Vita Pietro Vittozzi Mauro Zaccarelli Antonella Zanetti Sara Zito

Int J Infect Dis 2021 Mar 3;105:532-539. Epub 2021 Mar 3.

National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.

Background: Limited data are available about the predictors and outcomes associated with prolonged SARS-CoV-2 RNA shedding (VS).

Methods: A retrospective study including COVID-19 patients admitted to an Italian hospital between March 1 and July 1, 2020. Predictors of viral clearance (VC) and prolonged VS from the upper respiratory tract were assessed by Poisson regression and logistic regression analyses. The causal relation between VS and clinical outcomes was evaluated through an inverse probability weighted Cox model.

Results: The study included 536 subjects. The median duration of VS from symptoms onset was 18 days. The estimated 30-day probability of VC was 70.2%. Patients with comorbidities, lymphopenia at hospital admission, or moderate/severe respiratory disease had a lower chance of VC. The development of moderate/severe respiratory failure, delayed hospital admission after symptoms onset, baseline comorbidities, or D-dimer >1000ng/mL at admission independently predicted prolonged VS. The achievement of VC doubled the chance of clinical recovery and reduced the probability of death/mechanical ventilation.

Conclusions: Respiratory disease severity, comorbidities, delayed hospital admission and inflammatory markers negatively predicted VC, which resulted to be associated with better clinical outcomes. These findings highlight the importance of prompt hospitalization of symptomatic patients, especially where signs of severity or comorbidities are present.
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http://dx.doi.org/10.1016/j.ijid.2021.02.117DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927669PMC
March 2021

Modification of the existing maximum residue levels for cyflumetofen in various crops.

EFSA J 2021 Feb 24;19(2):e06373. Epub 2021 Feb 24.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants BASF Agro B.V. (represented by OAT Agrio Co. Ltd.) and Certis Europe B.V. submitted separate requests to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance cyflumetofen in various crops. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for citrus fruits, apricots, peaches, tomatoes, aubergines, cucumbers and hops. Adequate analytical methods for enforcement are available to control the residues of cyflumetofen on the fruit commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and on hops at the LOQ of 0.1 mg/kg. Based on the risk assessment results, EFSA concluded that the long-term intake of residues resulting from the use of cyflumetofen according to the reported agricultural practices is unlikely to present a risk to consumer health.
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http://dx.doi.org/10.2903/j.efsa.2021.6373DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903988PMC
February 2021

Focussed assessment of certain existing MRLs of concern for Spinosad.

EFSA J 2021 Feb 15;19(2):e06404. Epub 2021 Feb 15.

In compliance with Article 43 of Regulation (EC) No 396/2005, the EFSA received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for spinosad which might lead to consumers intake concerns on the basis of a new toxicological reference value established during the peer review and of the data currently available to EFSA. In order to identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for spinosad considering the new toxicological reference values and an acute risk could not be excluded for six commodities. Fall-back MRLs for all six commodities were proposed on the basis of the data received under the present assessment.
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http://dx.doi.org/10.2903/j.efsa.2021.6404DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883687PMC
February 2021

Modification of the existing maximum residue levels for difenoconazole in leafy brassica.

EFSA J 2021 Feb 9;19(2):e06407. Epub 2021 Feb 9.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to the group of leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for leafy brassica. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated LOQ of 0.01 mg/kg and for difenoconazole and metabolite CGA205375 in animal matrices at the validated LOQ of 0.01 mg/kg for meat muscle, fat, liver, kidney and eggs and at the validated LOQ of 0.005 mg/kg for milk. Based on the risk assessment results, EFSA concluded that for the crops assessed in this application the short-term intake of residues resulting from the use of difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. Long-term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. Overall, this risk assessment is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and has to be re-considered when the missing data become available. Additionally, this assessment does not take into consideration triazole derivative metabolites (TDMs) which may be generated by several pesticides belonging to the group of triazole fungicides as this application was submitted before September 2019 which is the date of application of the new strategy endorsed by the risk managers for the assessment of TDMs.
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http://dx.doi.org/10.2903/j.efsa.2021.6407DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7871204PMC
February 2021

Evaluation of confirmatory data following the Article 12 MRL review for propiconazole.

EFSA J 2021 Feb 5;19(2):e06405. Epub 2021 Feb 5.

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for propiconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. Following the decision on the non-renewal of the approval of propiconazole and the decision to lower the maximum residue levels (MRLs) for propiconazole to the limit of quantification (LOQ) for all commodities, the data gaps identified in the MRL review are no longer relevant. EFSA summarised some new studies on the toxicological profile of propiconazole metabolites CGA91305, SYN547889 and NOA436613, which were assessed by the rapporteur Member State. Overall, the available information is not sufficient to characterise the toxicological profile of metabolites convertible to 2,4-dichlorobenzoic acid as data gaps still exist for SYN547889, NOA436613, CGA118244, CGA118245, CGA91304 and CGA91305.
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http://dx.doi.org/10.2903/j.efsa.2021.6405DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863007PMC
February 2021

The unbalanced p53/SIRT1 axis may impact lymphocyte homeostasis in COVID-19 patients.

Int J Infect Dis 2021 Feb 10;105:49-53. Epub 2021 Feb 10.

INMI Lazzaro Spallanzani-IRCCS, Via Portuense, 292, 00149 Rome, Italy. Electronic address:

Background/objectives: A dysregulated inflammatory profile plays an important role in coronavirus disease-2019 (COVID-19) pathogenesis. Moreover, the depletion of lymphocytes is typically associated with an unfavourable disease course. We studied the role and impact of p53 and deacetylase Sirtuin 1 (SIRT1) on lymph-monocyte homeostasis and their possible effect on T and B cell signalling.

Methods: Gene expression analysis and flow cytometry were performed on peripheral blood mononuclear cells (PBMC) of 35 COVID-19 patients and 10 healthy donors (HD). Inflammatory cytokines, the frequency of Annexin+ cells among CD3+ T cells and CD19+ B cell subsets were quantified.

Results: PBMC from COVID-19 patients had a higher p53 expression, and higher concentrations of plasma proinflammatory cytokines (IL1β, TNF-α, IL8, and IL6) than HD. Deacetylase Sirtuin 1 (SIRT1) expression was significantly decreased in COVID-19 patients and was negatively correlated with p53 (p = 0.003 and r = -0.48). A lower expression of IL-7R and B Cell linker (BLNK), key genes for lymphocyte homeostasis and function, was observed in COVID-19 than in HD. The reduction of IgK and IgL chains was seen in lymphopenic COVID-19 patients. A significant increase in both apoptotic B and T cells were observed. Inflammatory cytokines correlated positively with p53 (IL-1β: r = 0.5 and p = 0.05; IL-8: r = 0.5 and p = 0.05) and negatively with SIRT1 (IL1-β: r = -0.5 and p = 0.04; TNF-α: r = -0.4 and p = 0.04).

Conclusions: Collectively, our data indicate that the inflammatory environment, the dysregulated p53/SIRT1 axis and low expression of IL7R and BLNK may impact cell survival, B cell signalling and antibody production in COVID-19 patients. Further studies are required to define the functional impact of low BLNK/IL7R expression during severe acute respiratory syndrome coronavirus-2 infection.
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http://dx.doi.org/10.1016/j.ijid.2021.02.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7872850PMC
February 2021

Review of the existing maximum residue levels for sulfuryl fluoride according to Article 12 of Regulation (EC) No 396/2005.

EFSA J 2021 Jan 28;19(1):e06390. Epub 2021 Jan 28.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sulfuryl fluoride. To assess the occurrence of sulfuryl fluoride and fluoride ion residues in plants, processed commodities and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRLs were calculated, but a consumer risk assessment could be carried out for sulfuryl fluoride only. Although no apparent risk to consumers was identified for sulfuryl fluoride, a standard consumer risk assessment to fluoride ion could not be performed, lacking information on the toxicological reference values for fluoride. Hence, an 'overall' consumer risk assessment could not be performed, only tentative MRLs proposal could be derived and measures for reduction of the consumer exposure should also be considered. Nevertheless, considering that fluoride ion is naturally occurring in food of plant and animal origin, EFSA performed an indicative calculation of the consumer exposure to estimate whether the uses currently authorised will contribute significantly to the overall consumer exposure to fluoride.
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http://dx.doi.org/10.2903/j.efsa.2021.6390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7842128PMC
January 2021

Modification of the existing maximum residue levels for tebufenozide in apricots and peaches.

EFSA J 2021 Jan 29;19(1):e06400. Epub 2021 Jan 29.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nisso Chemical Europe GmbH submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tebufenozide in apricots and peaches. The data submitted in support of the request were found to be sufficient to derive MRL proposals for apricots and peaches. Adequate analytical methods for enforcement are available to control the residues of tebufenozide on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of tebufenozide according to the reported agricultural practice is unlikely to present a risk to consumer health.
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http://dx.doi.org/10.2903/j.efsa.2021.6400DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845506PMC
January 2021

Review of the existing maximum residue levels for thiram according to Article 12 of Regulation (EC) No 396/2005.

EFSA J 2021 Jan 29;19(1):e06391. Epub 2021 Jan 29.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance thiram. Although this active substance is no longer authorised within the European Union, MRLs based on the use of thiram were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the existing import tolerances, and a consumer risk assessment was carried out for thiram only. Although no apparent risk to consumers was identified, the import tolerances were not fully supported by data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed.
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http://dx.doi.org/10.2903/j.efsa.2021.6391DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845507PMC
January 2021

Modification of the existing maximum residue levels and setting of import tolerances for metiram in various crops.

EFSA J 2021 Jan 22;19(1):e06342. Epub 2021 Jan 22.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Italia Srl submitted a request to the competent national authority in Italy to set import tolerances for the active substance metiram in passion fruits/maracujas, bananas, pineapples and to modify the existing maximum residue level (MRL) in celeriacs on the basis of intended northern Europe (NEU) use. The data submitted in support of the request were found sufficient to derive MRL proposals for pineapples and passion fruits/maracujas; according to the data provided, the existing EU MRL in bananas did not require modification and the data were not sufficient to derive an MRL proposal for celeriacs. A consumer exposure calculation, which considered only metiram uses, indicated no long-term consumer intake concerns, but is affected by several uncertainties related to the lack of residue data reflecting the existing uses of metiram. A second exposure scenario in which the lack of information was overcome by conservative assumptions indicated potential chronic exposure concerns for a number of diets. The contribution of residues in the crops under consideration to the long-term consumer exposure is low. The consumer exposure to ethylenethiourea (ETU) residues from the existing and intended metiram uses indicated no consumer intake concerns. However, the risk assessment is affected by a number of uncertainties that could not be addressed with the currently available data. EFSA therefore proposed that a comprehensive consumer exposure to ETU residues is performed in the framework of Article 12 MRL review, considering the existing uses of dithiocarbamates that are known to degrade to ETU in processed products. Considering the inconclusive results and overall uncertainties in the risk assessment, EFSA is of the opinion that further risk management discussions are required whether a modification of existing dithiocarbamate MRLs is justified prior to the finalisation of the MRL review on metiram and other dithiocarbamates.
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http://dx.doi.org/10.2903/j.efsa.2021.6342DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821744PMC
January 2021

Modification of the existing maximum residue levels for clopyralid in various commodities.

EFSA J 2021 Jan 22;19(1):e06389. Epub 2021 Jan 22.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva submitted a request to the competent national authority in Finland to modify the existing maximum residue levels (MRLs) for the active substance clopyralid in various commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for wheat, oat and for animal commodities. An adequate analytical method for enforcement is available to control the residues of clopyralid in the plant commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. The analytical methods for animal commodities are validated at LOQ of 0.01 mg/kg, but demonstration of extraction efficiency is lacking. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of clopyralid according to the reported agricultural practices is unlikely to present a risk to consumer health provided that risk mitigation measures are in place to avoid clopyralid residues in rotational and/or succeeding crops.
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http://dx.doi.org/10.2903/j.efsa.2021.6389DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821602PMC
January 2021

Reasoned opinion on the toxicological properties and maximum residue levels for propoxur.

EFSA J 2021 Jan 18;19(1):e06374. Epub 2021 Jan 18.

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to prepare a reasoned opinion on the toxicological properties and the existing maximum residue levels (MRLs) set for propoxur. EFSA was requested to assess the toxicological properties of propoxur and derive toxicological reference values, based on the toxicological assessment performed by Health Canada. EFSA was also requested to review the information provided by Member States and the UK on the metabolism of propoxur in plants and animals and on the current MRLs, as well as the limit of quantification (LOQ) that can be achieved with analytical methods used in MRL enforcement. Based on the information available to EFSA, toxicological reference values could not be derived for propoxur. No evidence was provided by Member States and UK that the existing EU MRLs need to be maintained as import tolerances. Information to support the current MRLs or alternative MRLs have not been provided by Member States and the UK. Codex MRLs are not in place. EFSA therefore recommended lowering of all existing EU MRLs for propoxur to the LOQ. According to the EU Reference Laboratories, sufficiently validated analytical methods are available to analyse for propoxur residues in all plant and animal commodities. Lacking toxicological reference values derived at EU level, a conclusion cannot be derived whether the setting of MRLs at the LOQs is sufficiently protective for the European consumers.
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http://dx.doi.org/10.2903/j.efsa.2021.6374DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7812492PMC
January 2021

Modification of the existing maximum residue levels for bentazone in beans and peas with and without pods.

EFSA J 2021 Jan 11;19(1):e06376. Epub 2021 Jan 11.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for bentazone in beans and peas with and without pods. The data submitted in support of the request were found to be sufficient to derive MRL proposals for peas with pods. Results from the residue trials indicated that there is no need to modify the existing MRLs for beans with pods, beans without pods and peas without pods. Adequate analytical methods for enforcement are available to control the residues of bentazone and its metabolites in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. EFSA concluded that the proposed use of bentazone on peas with pods will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health for parent bentazone. The risk assessment however is indicative and affected by additional, non-standard uncertainties resulting from the insufficient information related to the toxicological properties for 6-hydroxy-bentazone in the wheat metabolism study.
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http://dx.doi.org/10.2903/j.efsa.2021.6376DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7797947PMC
January 2021

Tunable Valley Splitting and Bipolar Operation in Graphene Quantum Dots.

Nano Lett 2021 Jan 15;21(2):1068-1073. Epub 2021 Jan 15.

Solid State Physics Laboratory, ETH Zurich, CH-8093 Zurich, Switzerland.

Quantum states in graphene are 2-fold degenerate in spins, and 2-fold in valleys. Both degrees of freedom can be utilized for qubit preparations. In our bilayer graphene quantum dots, we demonstrate that the valley g-factor , defined analogously to the spin g-factor for valley splitting in a perpendicular magnetic field, is tunable by over a factor of 4 from 20 to 90, by gate voltage adjustments only. Larger results from larger electronic dot sizes, determined from the charging energy. On our versatile device, bipolar operation, charging our quantum dot with charge carriers of the same or the opposite polarity as the leads, can be performed. Dots of both polarities are tunable to the first charge carrier, such that the transition from an electron to a hole dot by the action of the plunger gate can be observed. Addition of gates easily extends the system to host tunable double dots.
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http://dx.doi.org/10.1021/acs.nanolett.0c04343DOI Listing
January 2021

Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances for bifenthrin in maize grain and sweet corn.

EFSA J 2020 Dec 23;18(12):e06361. Epub 2020 Dec 23.

The applicant FMC Agricultural Solutions A/S submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new storage stability study was submitted and information on an analytical method for determination of bifenthrin in eggs was made available. The data gaps were sufficiently addressed. The new information provided, did not require a revision of the existing MRLs. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to set import tolerances for bifenthrin in sweet corn and maize grain. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for maize grain only. For sweet corn, data gaps were identified which precluded the derivation of an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of bifenthrin (sum of isomers) in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices. EFSA concluded that the short-term and long-term intake of residues resulting from the uses of bifenthrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment is affected by additional non-standard uncertainty related to the expiry of EU authorisation for a number of crops for which previously EU MRLs were established, and which are still included in the risk assessment.
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http://dx.doi.org/10.2903/j.efsa.2020.6361DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757675PMC
December 2020

Focussed assessment of certain existing MRLs of concern for methoxyfenozide.

EFSA J 2020 Dec 15;18(12):e06330. Epub 2020 Dec 15.

In compliance with Article 43 of Regulation (EC) No 396/2005, the EFSA received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for methoxyfenozide which might lead to consumers intake concerns on the basis of the new toxicological reference values agreed upon by Member States (MSs) on 13 December 2018. In order to identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for methoxyfenozide, considering the new toxicological reference values and an acute risk could not be excluded for eight commodities. A fall-back MRL was proposed for tomatoes and the MRL for citrus fruit could be confirmed considering the use of a peeling factor. No other fall-back good agricultural practices (GAPs) were received, and thus, a lowering of the MRLs for peaches, apples, pears and broccoli is proposed.
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http://dx.doi.org/10.2903/j.efsa.2020.6330DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737513PMC
December 2020

Evaluation of confirmatory data following the Article 12 MRL review and setting of an import tolerance for flutriafol in cucurbits (inedible peel).

EFSA J 2020 Dec 7;18(12):e06315. Epub 2020 Dec 7.

The applicant Cheminova A/S submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data for the active substance flutriafol that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005. The applicant provided residue trials on rice representative for an adjusted Good Agricultural Practice (GAP), metabolism studies in goats and storage stability data in tissues of animal origin addressing the data gaps identified in the MRL review. For the nature of residues in processed commodities, relevant to confirm the MRLs on pome fruits and wine grapes, the applicant referred to the information provided in a previous MRL application and already assessed by EFSA. The data gaps on the authorised uses on beetroots, melons and watermelons assessed in the MRL review were not addressed. At the same time, the applicant submitted a request to the United Kingdom to modify the existing maximum residue level (MRL) for flutriafol in cucurbits with inedible peel according to Article 6 of Regulation (EC) No 396/2005. The data submitted were found to be sufficient to derive an MRL proposal for these crops. EFSA concluded that the proposed use of flutriafol on the crops under assessment will not result in a consumer exposure exceeding the toxicological reference values for flutriafol and therefore is unlikely to pose a risk to consumers' health. Regarding the triazole derivative metabolites (TDMs), the conclusions reached in a previously issued assessment for another triazole fungicide are still valid. An update of the indicative consumer risk assessment for each individual metabolite is not necessary since the residues expected in the concerned commodities are covered.
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http://dx.doi.org/10.2903/j.efsa.2020.6315DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7720798PMC
December 2020

Review of the existing maximum residue levels for quinoxyfen according to Article 12 of Regulation (EC) No 396/2005.

EFSA J 2020 Dec 4;18(12):e06316. Epub 2020 Dec 4.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance quinoxyfen. Although this active substance is no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and an import tolerance was reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerance requested, and a consumer risk assessment was carried out considering the toxicological reference value established for the first inclusion under Directive 91/414/EEC. All CXLs and import tolerance were found to be adequately supported by data and no risk to consumers was identified.
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http://dx.doi.org/10.2903/j.efsa.2020.6316DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716242PMC
December 2020

Modification of the existing maximum residue levels for sodium 5-nitroguaiacolate, sodium -nitrophenolate and sodium -nitrophenolate (sodium nitrocompounds) in table olives and olives for oil production.

EFSA J 2020 Nov 24;18(11):e06313. Epub 2020 Nov 24.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Asahi Chemical Europe s.r.o. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substances sodium 5-nitroguaiacolate (Na 5-NG), sodium o-nitrophenolate (Na -NP) and sodium p-nitrophenolate (Na -NP) in table olives and olives for oil production in support of the intended SEU use. The data submitted in support of this MRL application were sufficient to derive an MRL of 0.12 mg/kg (at the combined limit of quantification (LOQ) of the three sodium nitrocompounds as validated in the framework of the residue trials). This higher MRL does not reflect residues in olives from the intended use but refers to occurrence of p-nitrophenolate (-NP) from unidentified source. As -NP was present in all untreated olive samples regardless of the country of origin and the year of the treatment, in some cases at levels above the enforcement LOQ of 0.01 mg/kg, the applicant analysed residue trial samples using a method with a higher validated LOQ of 0.1 mg/kg for Na -NP. The competent authorities shall be aware that residues of -NP at levels < 0.1 mg/kg in olives are not related to the use of sodium nitrocompounds on the crop but to other sources of unknown origin. The current analytical methods for enforcement control residues of sodium nitrocompounds in high oil content matrices at the validated LOQ of 0.01 mg/kg per substance (combined LOQ of 0.03 mg/kg). Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of sodium nitrocompounds according to the reported agricultural practice and occurrence of -NP from unidentified source is unlikely to present a risk to consumer health.
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http://dx.doi.org/10.2903/j.efsa.2020.6313DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7684972PMC
November 2020

Setting of import tolerances for chlorantraniliprole in strawberries and pulses.

EFSA J 2020 Nov 16;18(11):e06300. Epub 2020 Nov 16.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant FMC Agro Limited submitted a request to the competent national authority in the UK to set import tolerances for the active substance chlorantraniliprole in strawberries and the whole category pulses (beans, lentils, peas and lupins/lupini beans). The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal for the whole category pulses. The available data are not sufficient to derive an import tolerance for strawberries and no modification of the current EU MRL is required. Adequate analytical methods for enforcement are available to control the residues of chlorantraniliprole in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long-term intake of residues resulting from the use of chlorantraniliprole according to the reported agricultural practice is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented.
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http://dx.doi.org/10.2903/j.efsa.2020.6300DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7667575PMC
November 2020

Modification of the existing maximum residue levels for flupyradifurone and DFA in rapeseeds/canola seeds and mustard seeds.

EFSA J 2020 Nov 3;18(11):e06298. Epub 2020 Nov 3.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS - Crop Science Division submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRL) for the active substance flupyradifurone and its metabolite DFA in rapeseeds/canola seeds and mustard seeds. The data submitted in support of the request were found sufficient to derive MRL proposals for both compounds in rapeseeds and mustard seeds. Adequate analytical methods for enforcement are available to control the relevant residues in plant matrices under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues of flupyradifurone and of its metabolite DFA resulting from the use of flupyradifurone is unlikely to present a risk to consumer health.
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http://dx.doi.org/10.2903/j.efsa.2020.6298DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607416PMC
November 2020

Modification of the existing maximum residue level for deltamethrin in carobs/Saint John's breads.

EFSA J 2020 Oct 27;18(10):e06271. Epub 2020 Oct 27.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS - Crop Science Division submitted a request to the competent national authority in Spain to modify the existing maximum residue level (MRL) for the active substance deltamethrin in carobs/Saint John's breads. The data submitted in support of the request were found to suffice to derive an MRL proposal for carobs. An adequate analytical method for enforcement is available to control the residues of deltamethrin in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results using the PRIMo rev. 3.1 model, EFSA concluded that the short-term consumer exposure for the intended post-harvest use on carobs did not exceed the toxicological reference value. The long-term intake of residues of deltamethrin indicated a consumer risk. Although residues in carobs are minor contributors to the overall chronic consumer exposure, a risk management consideration is required to decide whether the MRL proposal for carobs is acceptable. The risk assessment shall be regarded as indicative and affected by non-standard uncertainties.
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http://dx.doi.org/10.2903/j.efsa.2020.6271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590993PMC
October 2020

Modification of the existing maximum residue levels for fluroxypyr in chives, celery leaves, parsley, thyme and basil and edible flowers.

EFSA J 2020 Oct 22;18(10):e06273. Epub 2020 Oct 22.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt für Landwirtschaftund Gartenbau (LLG) submitted two applications to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance fluroxypyr in chives, celery leaves, parsley, thyme and basil and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under consideration, except for thyme for which a tentative MRL proposal was derived for further risk management considerations. Adequate analytical methods for enforcement are available to control the residues of fluroxypyr in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the use of fluroxypyr according to the reported agricultural practices is unlikely to present a risk to consumer health.
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http://dx.doi.org/10.2903/j.efsa.2020.6273DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7579707PMC
October 2020

Modification of the existing maximum residue level for picloram in flowering brassica.

EFSA J 2020 Oct 22;18(10):e06272. Epub 2020 Oct 22.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, Dienstleistungszentrum Ländlicher Raum Rheinpfalz, submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance picloram in flowering brassica. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli, cauliflowers and other flowering brassica. Adequate analytical methods for enforcement are available to control the residues of picloram and its conjugates in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of picloram according to the reported agricultural practices is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment, are presented.
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http://dx.doi.org/10.2903/j.efsa.2020.6272DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7579682PMC
October 2020

Early expansion of myeloid-derived suppressor cells inhibits SARS-CoV-2 specific T-cell response and may predict fatal COVID-19 outcome.

Cell Death Dis 2020 10 27;11(10):921. Epub 2020 Oct 27.

National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS- Via Portuense, 292- 00149, Rome, Italy.

The immunological mechanisms underlying the clinical presentation of SARS-CoV-2 infection and those influencing the disease outcome remain to be defined. Myeloid-derived suppressor cells (MDSC) have been described to be highly increased during COVID-19, however, their role remains elusive. We performed an in depth analysis of MDSC in 128 SARS-CoV-2 infected patients. Polymorphonuclear (PMN)-MDSC expanded during COVID-19, in particular in patients who required intensive care treatments, and correlated with IL-1β, IL-6, IL-8, and TNF-α plasma levels. PMN-MDSC inhibited T-cells IFN-γ production upon SARS-CoV-2 peptides stimulation, through TGF-β- and iNOS-mediated mechanisms, possibly contrasting virus elimination. Accordingly, a multivariate regression analysis found a strong association between PMN-MDSC percentage and fatal outcome of the disease. The PMN-MDSC frequency was higher in non-survivors than survivors at the admission time, followed by a decreasing trend. Interestingly, this trend was associated with IL-6 increase in non-survivors but not in survivors. In conclusion, this study indicates PMN-MDSC as a novel factor in the pathogenesis of SARS-CoV2 infection, and open up to new therapeutic options.
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http://dx.doi.org/10.1038/s41419-020-03125-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590570PMC
October 2020