4,032
Views
14
CrossRef citations to date
0
Altmetric
Original Articles

Risk assessment of plant food supplements and other herbal products containing aristolochic acids using the margin of exposure (MOE) approach

ORCID Icon, , &
Pages 135-144 | Received 12 Oct 2016, Accepted 13 Nov 2016, Published online: 16 Dec 2016

References

  • Abdullah R, Alhusainy W, Woutersen J, Rietjens IMCM, Punt A. 2016. Predicting points of departure for risk assessment based on in vitro cytotoxicity data and physiologically based kinetic (PBK) modeling: the case of kidney toxicity induced by aristolochic acid I. Food Chem Toxicol. 92:104–116.
  • Arlt VM, Stiborova M, Schmeiser HH. 2002. Aristolochic acid as a probable human cancer hazard in herbal remedies: a review. Mutagenesis. 17:265–277.
  • Barlow S, Renwick A, Kleiner J, Bridges J, Busk L, Dybing E, Edler L, Eisenbrand G, Fink-Gremmels J, Knaap A, et al. 2006. Risk assessment of substances that are both genotoxic and carcinogenic: report of an international conference organized by EFSA and WHO with support of ILSI Europe. Food Chem Toxicol. 44:1636–1650.
  • Bieler CA, Stiborova M, Wiessler M, Cosyns J-P, De Strihou CVY, Schmeiser HH. 1997. 32p-post-labelling analysis of DNA adducts formed by aristolochic acid in tissues from patients with Chinese herbs nephropathy. Carcinogenesis. 18:1063–1067.
  • Chan W, Lee KC, Liu N, Cai Z. 2007. A sensitivity enhanced high-performance liquid chromatography fluorescence method for the detection of nephrotoxic and carcinogenic aristolochic acid in herbal medicines. J Chromatogr. 1164:113–119.
  • Chan W, Yue H, Poon WT, Chan Y-W, Schmitz OJ, Kwong DW, Wong RN, Cai Z. 2008. Quantification of aristolochic acid-derived DNA adducts in rat kidney and liver by using liquid chromatography–electrospray ionization mass spectrometry. Mutat Res/Fund Mol Mech Muta. 646:17–24.
  • Cheung TP, Xue C, Leung K, Chan K, Li CG. 2006. Aristolochic acids detected in some raw Chinese medicinal herbs and manufactured herbal products–a consequence of inappropriate nomenclature and imprecise labelling? Clin Toxicol. 44:371–378.
  • Debelle FD, Vanherweghem J-L, Nortier JL. 2008. Aristolochic acid nephropathy: a worldwide problem. Kidney Int. 74:158–169.
  • Dong H, Suzuki N, Torres MC, Bonala RR, Johnson F, Grollman AP, Shibutani S. 2006. Quantitative determination of aristolochic acid-derived DNA adducts in rats using 32p-postlabeling/polyacrylamide gel electrophoresis analysis. Drug Metab Dispos. 34:1122–1127.
  • EFSA. 2005. European Food Safety Authority. opinion of the scientific committee on a request from EFSA related to a harmonised approach for risk assessment of substances which are both genotoxic and carcinogenic. EFSA J. 282:1–31.
  • EFSA. 2009. EFSA compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other substances of concern. EFSA J. 7:281.
  • EFSA. 2012. Guidance on selected default values to be used by the EFSA scientific committee, scientific panels and units in the absence of actual measured data. EFSA J. 10:2579.
  • EMEA. 2000. The European Agency for the evaluation of medicinal products, position paper on the risks associated with the use of herbal products containing aristolochia species. Document EMEA/HMPWP/23/00. London; p. 1–10.
  • Felter SP, Conolly RB, Bercu JP, Bolger PM, Boobis AR, Bos PM, Carthew P, Doerrer NG, Goodman JI, Harrouk WA. 2011. A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens. Crit Rev Toxicol. 41:507–544.
  • Grollman AP, Scarborough J, Jelakovic B. 2009. Aristolochic acid nephropathy: an environmental and iatrogenic disease. Adv Mol Toxicol. 3:211–227.
  • Hashimoto K, Higuchi M, Makino B, Sakakibara I, Kubo M, Komatsu Y, Maruno M, Okada M. 1999. Quantitative analysis of aristolochic acids, toxic compounds, contained in some medicinal plants. J Ethnopharmacol. 64:185–189.
  • Hsieh S-C, Huang M-F, Lin B-S, Chang H-T. 2006. Determination of aristolochic acid in Chinese herbal medicine by capillary electrophoresis with laser-induced fluorescence detection. J Chromatogr. 1105:127–134.
  • Huang C-Y, Tseng M-C, Lin J-H. 2005. Analyzing aristolochic acids in Chinese herbal preparations using LC/MS/MS. J Food Drug Anal. 13:125–131.
  • IARC. 2002. IARC monographs on the evaluation of carcinogenic risks to humans. Lyon: World Health Organization; p. 68–128.
  • Ioset J-R, Raoelison G, Hostettmann K. 2003. Detection of aristolochic acid in Chinese phytomedicines and dietary supplements used as slimming regimens. Food Chem Toxicol. 41:29–36.
  • Koh H, Wang H, Zhou S, Chan E, Woo S. 2006. Detection of aristolochic acid I, tetrandrine and fangchinoline in medicinal plants by high performance liquid chromatography and liquid chromatography/mass spectrometry. J Pharm Biomed Anal. 40:653–661.
  • Kuo C-H, Lee C-W, Lin S-C, Tsai I-L, Lee -S-S, Tseng YJ, Kang -J-J, Peng F-C, Wei-Chu L. 2010. Rapid determination of aristolochic acids I and II in herbal products and biological samples by ultra-high-pressure liquid chromatography–tandem mass spectrometry. Talanta. 80:1672–1680.
  • Lai M-N, Lai J-N, Chen P-C, Hsieh S-C, Hu F-C, Wang J-D. 2010. Risks of kidney failure associated with consumption of herbal products containing Mu Tong or Fangchi: a population-based case-control study. Am J Kidney Dis. 55:507–518.
  • Lee T-Y, Wu M-L, Deng J-F, Hwang D-F. 2002. High-performance liquid chromatographic determination for aristolochic acid in medicinal plants and slimming products. J Chromatogr B. 766:169–174.
  • Martena MJ, van der Wielen JC, van de Laak LF, Konings EJ, de Groot HN, Rietjens IMCM. 2007. Enforcement of the ban on aristolochic acids in Chinese traditional herbal preparations on the Dutch market. Anal Bioanal Chem. 389:263–275.
  • Medsafe. 2003. Herbal, traditional and complementary medicines. Wellington: New Zealand Medicines and Medical Devices Safety Authority.
  • Mei N, Arlt VM, Phillips DH, Heflich RH, Chen T. 2006. DNA adduct formation and mutation induction by Aristolochic acid in rat kidney and liver. Mutat Res/Fund Mol Mech Muta. 602:83–91.
  • Mengs U, Lang W, Poch J-A. 1982. The carcinogenic action of aristolochic acid in rats. Arch Toxicol. 51:107–119.
  • Paini A, Scholz G, Marin-Kuan M, Schilter B, O’Brien J, van Bladeren PJ, Rietjens IMCM. 2011. Quantitative comparison between in vivo DNA adduct formation from exposure to selected DNA-reactive carcinogens, natural background levels of DNA adduct formation and tumour incidence in rodent bioassays. Mutagenesis. 26:605–618.
  • Pfau W, Schmeiser HH, Wiessler M. 1990. 32p-postlabelling analysis of the DNA adducts formed by aristolochic acid I and II. Carcinogenesis. 11:1627–1633.
  • Schaneberg B, Khan I. 2004. Analysis of products suspected of containing Aristolochia or Asarum species. J Ethnopharmacol. 94:245–249.
  • Schilter B, Andersson C, Anton R, Constable A, Kleiner J, O’Brien J, Renwick A, Korver O, Smit F, Walker R. 2003. Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements. Food Chem Toxicol. 41:1625–1649.
  • Schmeiser HH, Bieler CA, Wiessler M, De Strihou CVY, Cosyns J-P. 1996. Detection of DNA adducts formed by aristolochic acid in renal tissue from patients with Chinese herbs nephropathy. Cancer Res. 56:2025–2028.
  • Speijers G, Bottex B, Dusemund B, Lugasi A, Tóth J, Amberg‐Müller J, Galli CL, Silano V, Rietjens IMCM. 2010. Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an European Food Safety authority‐tiered approach. Mol Nutr Food Res. 54:175–185.
  • Stiborová M, Frei E, Arlt VM, Schmeiser HH. 2008. Metabolic activation of carcinogenic aristolochic acid, a risk factor for Balkan endemic nephropathy. Mutat Res/Rev Mutat Res. 658:55–67.
  • Stiborová M, Frei E, Sopko B, Sopková K, Marková V, Laňková M, Kumstýřová T, Wiessler M, Schmeiser HH. 2003. Human cytosolic enzymes involved in the metabolic activation of carcinogenic aristolochic acid: evidence for reductive activation by human NAD(P)H: quinone oxidoreductase. Carcinogenesis. 24:1695–1703.
  • USFDA. 2001. Aristolochic acid: FDA warns consumers to discontinue use of botanical products that contain aristolochic acid. US Food and Drug Administration; 2001 April 11; Silver Spring (MD).
  • Vaclavik L, Krynitsky AJ, Rader JI. 2014. Quantification of aristolochic acids I and II in herbal dietary supplements by ultra-high-performance liquid chromatography–multistage fragmentation mass spectrometry. Food Addit Contam. 31:784–791.
  • Van den Berg SJPL, Restani P, Boersma MG, Delmulle L, Rietjens IMCM. 2011. Levels of genotoxic and carcinogenic compounds in plant food supplements and associated risk assessment. Food Nutr Sci. 2:989–1010.
  • Vanhaelen M, Vanhaelen-Fastre R, But P, Vanherweghem J-L. 1994. Identification of aristolochic acid in Chinese herbs. Lancet. 343:174.
  • Vanherweghem J-L, Tielemans C, Abramowicz D, Depierreux M, Vanhaelen-Fastre R, Vanhaelen M, Dratwa M, Richard C, Vandervelde D, Verbeelen D, Jadoul M. 1993. Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet. 341:387–391.
  • Wang Y, Chan W. 2014. Determination of aristolochic acids by high-performance liquid chromatography with fluorescence detection. J Agric Food Chem. 62:5859–5864.
  • Wei F, Cheng XL, Ma LY, Jin WT, Schaneberg BT, Khan IA, Lin RC. 2005. Analysis of aristolochic acids and analogues in medicinal plants and their commercial products by Hplc‐Pad‐Esi/Ms. Phytochem Anal. 16:222–230.
  • Xu Y-Q, Li X-W, Liu G-X, Wang X, Shang M-Y, Li X-M, Cai S-Q. 2013. Comparative study of the contents of analogues of aristolochic acid in two kinds of aristolochiae fructus by high-performance liquid chromatography. J Nat Med. 67:113–122.
  • Zhang H, Cifone M, Murli H, Erexson G, Mecchi M, Lawlor T. 2004. Application of simplified in vitro screening tests to detect genotoxicity of aristolochic acid. Food Chem Toxicol. 42:2021–2028.
  • Zhao Z-Z, Liang Z-T, Jiang Z-H, Leung KS-Y, Chan C-L, Chan H-Y, Sin J, Man T-O, Law K-W. 2008. Comparative study on the aristolochic acid I content of Herba Asari for safe use. Phytomedicine. 15:741–748.
  • Zhou X, Zheng C, Sun J, You T. 2006. Analysis of nephroloxic and carcinogenic aristolochic acids in aristolochia plants by capillary electrophoresis with electrochemical detection at a carbon fiber microdisk electrode. J Chromatogr. 1109:152–159.