Risk to human and animal health related to the presence of 4,15-diacetoxyscirpenol in food and feed

H.K. Knutsen; J. Alexander; L. Barregård; M. Bignami; B. Brüschweiler; S. Ceccatelli; B. Cottrill; M. Dinovi; B. Grasl-Kraupp; C. Hogstrand; L.R. Hoogenboom; C.S. Nebbia; I.P. Oswald; A. Petersen; M. Rose; A.-C. Roudot; T. Schwerdtle; C. Vleminckx; G. Vollmer; H. Wallace; S. De Saeger; G.S. Eriksen; P. Farmer; J.-M. Fremy; Y.Y. Gong; K. Meyer; D. Parent-Massin; H. van Egmond; A. Altieri; P. Colombo; Z. Horváth; S. Levorato; L. Edler; EFSA Panelon Contaminants in the Food Chain (contam)

doi:10.2903/j.efsa.2018.5367

Risk to human and animal health related to the presence of 4,15-diacetoxyscirpenol in food and feed

H.K. Knutsen, J. Alexander, L. Barregård, M. Bignami, B. Brüschweiler, S. Ceccatelli, B. Cottrill, M. Dinovi, B. Grasl-Kraupp, C. Hogstrand, L.R. Hoogenboom, C.S. Nebbia, I.P. Oswald, A. Petersen, M. Rose, A.-C. Roudot, T. Schwerdtle, C. Vleminckx, G. Vollmer, H. WallaceS. De Saeger, G.S. Eriksen, P. Farmer, J.-M. Fremy, Y.Y. Gong, K. Meyer, D. Parent-Massin, H. van Egmond, A. Altieri, P. Colombo, Z. Horváth, S. Levorato, L. Edler, EFSA Panelon Contaminants in the Food Chain (contam)

Research output: Contribution to journal › Article › peer-review

34 Citations (Scopus)

Abstract

4,15-Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the available data set, human acute and chronic health-based guidance values (HBGV) were established based on data obtained in clinical trials of DAS as an anticancer agent (anguidine) after intravenous administration to cancer patients. The CONTAM Panel considered these data as informative for the hazard characterisation of DAS after oral exposure. The main adverse effects after acute and repeated exposure were emesis, with a no-observed-adverse-effect level (NOAEL) of 32 μg DAS/kg body weight (bw), and haematotoxicity, with a NOAEL of 65 μg DAS/kg bw, respectively. An acute reference dose (ARfD) of 3.2 μg DAS/kg bw and a tolerable daily intake (TDI) of 0.65 μg DAS/kg bw were established. Based on over 15,000 occurrence data, the highest acute and chronic dietary exposures were estimated to be 0.8 and 0.49 μg DAS/kg bw per day, respectively, and were not of health concern for humans. The limited information for poultry, pigs and dogs indicated a low risk for these animals at the estimated DAS exposure levels under current feeding practices, with the possible exception of fattening chicken. Assuming similar or lower sensitivity than for poultry, the risk was considered overall low for other farm and companion animal species for which no toxicity data were available. In consideration of the similarities of several trichothecenes and the likelihood of co-exposure via food and feed, it could be appropriate to perform a cumulative risk assessment for this group of substances. © 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Original language	English
Journal	EFSA J.
Volume	16
Issue number	8
DOIs	https://doi.org/10.2903/j.efsa.2018.5367
Publication status	Published - 16 Aug 2018

Keywords

4,15 - diacetoxyscirpenol
anguidine
DAS
exposure
human and animal risk assessment
MAS
toxicity

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.2903/j.efsa.2018.5367

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Knutsen, H. K., Alexander, J., Barregård, L., Bignami, M., Brüschweiler, B., Ceccatelli, S., Cottrill, B., Dinovi, M., Grasl-Kraupp, B., Hogstrand, C., Hoogenboom, L. R., Nebbia, C. S., Oswald, I. P., Petersen, A., Rose, M., Roudot, A.-C., Schwerdtle, T., Vleminckx, C., Vollmer, G., ... (contam), EFSA. P. C. I. T. F. C. (2018). Risk to human and animal health related to the presence of 4,15-diacetoxyscirpenol in food and feed. EFSA J., 16(8). https://doi.org/10.2903/j.efsa.2018.5367

@article{bd3ebaf9df38438c9914aefc01fac77e,

title = "Risk to human and animal health related to the presence of 4,15-diacetoxyscirpenol in food and feed",

abstract = "4,15-Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the available data set, human acute and chronic health-based guidance values (HBGV) were established based on data obtained in clinical trials of DAS as an anticancer agent (anguidine) after intravenous administration to cancer patients. The CONTAM Panel considered these data as informative for the hazard characterisation of DAS after oral exposure. The main adverse effects after acute and repeated exposure were emesis, with a no-observed-adverse-effect level (NOAEL) of 32 μg DAS/kg body weight (bw), and haematotoxicity, with a NOAEL of 65 μg DAS/kg bw, respectively. An acute reference dose (ARfD) of 3.2 μg DAS/kg bw and a tolerable daily intake (TDI) of 0.65 μg DAS/kg bw were established. Based on over 15,000 occurrence data, the highest acute and chronic dietary exposures were estimated to be 0.8 and 0.49 μg DAS/kg bw per day, respectively, and were not of health concern for humans. The limited information for poultry, pigs and dogs indicated a low risk for these animals at the estimated DAS exposure levels under current feeding practices, with the possible exception of fattening chicken. Assuming similar or lower sensitivity than for poultry, the risk was considered overall low for other farm and companion animal species for which no toxicity data were available. In consideration of the similarities of several trichothecenes and the likelihood of co-exposure via food and feed, it could be appropriate to perform a cumulative risk assessment for this group of substances. {\textcopyright} 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.",

keywords = "4,15 - diacetoxyscirpenol, anguidine, DAS, exposure, human and animal risk assessment, MAS, toxicity",

author = "H.K. Knutsen and J. Alexander and L. Barreg{\aa}rd and M. Bignami and B. Br{\"u}schweiler and S. Ceccatelli and B. Cottrill and M. Dinovi and B. Grasl-Kraupp and C. Hogstrand and L.R. Hoogenboom and C.S. Nebbia and I.P. Oswald and A. Petersen and M. Rose and A.-C. Roudot and T. Schwerdtle and C. Vleminckx and G. Vollmer and H. Wallace and {De Saeger}, S. and G.S. Eriksen and P. Farmer and J.-M. Fremy and Y.Y. Gong and K. Meyer and D. Parent-Massin and {van Egmond}, H. and A. Altieri and P. Colombo and Z. Horv{\'a}th and S. Levorato and L. Edler and (contam), {EFSA Panelon Contaminants in the Food Chain}",

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doi = "10.2903/j.efsa.2018.5367",

language = "English",

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journal = "EFSA J.",

issn = "1831-4732",

publisher = "Wiley-Blackwell Publishing Ltd.",

number = "8",

}

Knutsen, HK, Alexander, J, Barregård, L, Bignami, M, Brüschweiler, B, Ceccatelli, S, Cottrill, B, Dinovi, M, Grasl-Kraupp, B, Hogstrand, C, Hoogenboom, LR, Nebbia, CS, Oswald, IP, Petersen, A, Rose, M, Roudot, A-C, Schwerdtle, T, Vleminckx, C, Vollmer, G, Wallace, H, De Saeger, S, Eriksen, GS, Farmer, P, Fremy, J-M, Gong, YY, Meyer, K, Parent-Massin, D, van Egmond, H, Altieri, A, Colombo, P, Horváth, Z, Levorato, S, Edler, L & (contam), EFSAPCITFC 2018, 'Risk to human and animal health related to the presence of 4,15-diacetoxyscirpenol in food and feed', EFSA J., vol. 16, no. 8. https://doi.org/10.2903/j.efsa.2018.5367

TY - JOUR

T1 - Risk to human and animal health related to the presence of 4,15-diacetoxyscirpenol in food and feed

AU - Knutsen, H.K.

AU - Alexander, J.

AU - Barregård, L.

AU - Bignami, M.

AU - Brüschweiler, B.

AU - Ceccatelli, S.

AU - Cottrill, B.

AU - Dinovi, M.

AU - Grasl-Kraupp, B.

AU - Hogstrand, C.

AU - Hoogenboom, L.R.

AU - Nebbia, C.S.

AU - Oswald, I.P.

AU - Petersen, A.

AU - Rose, M.

AU - Roudot, A.-C.

AU - Schwerdtle, T.

AU - Vleminckx, C.

AU - Vollmer, G.

AU - Wallace, H.

AU - De Saeger, S.

AU - Eriksen, G.S.

AU - Farmer, P.

AU - Fremy, J.-M.

AU - Gong, Y.Y.

AU - Meyer, K.

AU - Parent-Massin, D.

AU - van Egmond, H.

AU - Altieri, A.

AU - Colombo, P.

AU - Horváth, Z.

AU - Levorato, S.

AU - Edler, L.

AU - (contam), EFSA Panelon Contaminants in the Food Chain

PY - 2018/8/16

Y1 - 2018/8/16

N2 - 4,15-Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the available data set, human acute and chronic health-based guidance values (HBGV) were established based on data obtained in clinical trials of DAS as an anticancer agent (anguidine) after intravenous administration to cancer patients. The CONTAM Panel considered these data as informative for the hazard characterisation of DAS after oral exposure. The main adverse effects after acute and repeated exposure were emesis, with a no-observed-adverse-effect level (NOAEL) of 32 μg DAS/kg body weight (bw), and haematotoxicity, with a NOAEL of 65 μg DAS/kg bw, respectively. An acute reference dose (ARfD) of 3.2 μg DAS/kg bw and a tolerable daily intake (TDI) of 0.65 μg DAS/kg bw were established. Based on over 15,000 occurrence data, the highest acute and chronic dietary exposures were estimated to be 0.8 and 0.49 μg DAS/kg bw per day, respectively, and were not of health concern for humans. The limited information for poultry, pigs and dogs indicated a low risk for these animals at the estimated DAS exposure levels under current feeding practices, with the possible exception of fattening chicken. Assuming similar or lower sensitivity than for poultry, the risk was considered overall low for other farm and companion animal species for which no toxicity data were available. In consideration of the similarities of several trichothecenes and the likelihood of co-exposure via food and feed, it could be appropriate to perform a cumulative risk assessment for this group of substances. © 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

AB - 4,15-Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the available data set, human acute and chronic health-based guidance values (HBGV) were established based on data obtained in clinical trials of DAS as an anticancer agent (anguidine) after intravenous administration to cancer patients. The CONTAM Panel considered these data as informative for the hazard characterisation of DAS after oral exposure. The main adverse effects after acute and repeated exposure were emesis, with a no-observed-adverse-effect level (NOAEL) of 32 μg DAS/kg body weight (bw), and haematotoxicity, with a NOAEL of 65 μg DAS/kg bw, respectively. An acute reference dose (ARfD) of 3.2 μg DAS/kg bw and a tolerable daily intake (TDI) of 0.65 μg DAS/kg bw were established. Based on over 15,000 occurrence data, the highest acute and chronic dietary exposures were estimated to be 0.8 and 0.49 μg DAS/kg bw per day, respectively, and were not of health concern for humans. The limited information for poultry, pigs and dogs indicated a low risk for these animals at the estimated DAS exposure levels under current feeding practices, with the possible exception of fattening chicken. Assuming similar or lower sensitivity than for poultry, the risk was considered overall low for other farm and companion animal species for which no toxicity data were available. In consideration of the similarities of several trichothecenes and the likelihood of co-exposure via food and feed, it could be appropriate to perform a cumulative risk assessment for this group of substances. © 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

KW - 4,15 - diacetoxyscirpenol

KW - anguidine

KW - DAS

KW - exposure

KW - human and animal risk assessment

KW - MAS

KW - toxicity

U2 - 10.2903/j.efsa.2018.5367

DO - 10.2903/j.efsa.2018.5367

M3 - Article

SN - 1831-4732

VL - 16

JO - EFSA J.

JF - EFSA J.

IS - 8

ER -

Risk to human and animal health related to the presence of 4,15-diacetoxyscirpenol in food and feed

Abstract

Keywords

UN SDGs

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