609
Views
2
CrossRef citations to date
0
Altmetric
Comprehensive Review

Non-clinical toxicity studies on bioactive compounds within the framework of nutritional and health claims

, &
Pages S13-S21 | Received 05 Dec 2014, Accepted 16 Apr 2015, Published online: 01 Aug 2015

References

  • Abraham SK, Khandelwal N. 2013. Ascorbic acid and dietary polyphenol combinations protect against genotoxic damage induced in mice by endogenous nitrosation. Mutat Res 757:167–172
  • Allred CD, Allred KF, Ju YH, Virant SM, Helferich WG. 2001. Soy diets containing varying amounts of genistein stimulate growth of estrogen-dependent (MCF-7) tumors in a dose-dependent manner. Cancer Res 61:5045–5050
  • American Dietetic Association (ADA). 2009. Position of the American Dietetic Association. Functional foods. American Dietetic Association. J Am Diet Assoc 109:1–2
  • Archibeque-Engle SL, Tessari JD, Winn DT, Keefe TJ, Nett TM, Zheng T. 1997. Comparison of organochlorine pesticide and polychlorinated biphenyl residues in human breast adipose tissue and serum. J Toxicol Environ Health 52:285–293
  • Ashwell M. 2004. ILSI Europe Concise Monograph Series. Conceptos sobre alimentos funcionales. ILSI CM Func Foods [Informe] p. 7–10
  • Bouayed J, Bohn T. 2010. Exogenous antioxidants – double-edged swords in cellular redox state: health beneficial effects at physiologic doses versus deleterious effects at high doses. Oxid Med Cell Longev 3:228–237
  • Burton K. 1956. A study of the conditions and mechanism of the diphenylamine reaction for the colorimetric estimation of deoxyribonucleic acid. Biochem J 62:315–323
  • Cameán AM, Repetto M. 2012. Toxicología alimentaria. Madrid España: Ediciones Díaz de Santos
  • Chrzan BG1, Bradford PG. 2007. Phytoestrogens activate estrogen receptor beta1 and estrogenic responses in human breast and bone cancer cell lines. Mol Nutr Food Res 51:171–177
  • Dees C, Foster JS, Ahamed S, Wimalasena J. 1997. Dietary estrogens stimulate human breast cells to enter the cell cycle. Environ Health Perspect 105:633–636
  • Demma J, El-Seedi H, Engidawork E, Aboye TL, Göransson U, Hellman B. 2013. An in vitro study on the DNA damaging effects of phytochemicals partially isolated from an extract of Glinus lotoides. Phytother Res 27:507–514
  • Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. OJ L 276, 20.10.2010, p. 33–79
  • Ekeanyanwu RC, Njoku OU. 2014. Acute and subacute oral toxicity study on the flavonoid rich fraction of Monodora tenuifolia seed in albino rats. Asian Pac J Trop Biomed 4:194–202
  • EUR ECVAM – Scientific and Technical Research Series–. 2013. Raffaella Corvi, Federica Madia, Andrew Worth and Maurice Whelan. Strategy to Avoid and Reduce Animal Use in Genotoxicity Testing. ISSN 1018-5593 (print) ISSN 1831-9424 (online)
  • European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA Panel). 2011. Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. December 2011
  • European Food Safety Authority (EFSA) Scientific Committee. 2011a. Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment. EFSA J 9:2379
  • European Food Safety Authority (EFSA) Scientific Committee. 2011b. Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed. EFSA J 9:2438
  • European Food Safety Authority (EFSA) Scientific Committee. 2013. Scientific opinion on the hazard assessment of endocrine disruptors: scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment. EFSA J 11:3132
  • European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA). 2014. Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes. EFSA J 12:3894
  • Farsi E, Shafaei A, Hor SY, Ahamed MB, Yam MF, Asmawi MZ, Ismail Z. 2013. Genotoxicity and acute and subchronic toxicity studies of a standardized methanolic extract of Ficus deltoidea leaves. Clinics (Sao Paulo) 68:865–875
  • Gafrikova M, Galova E, Sevcovicova A, Imreova A, Imreova P, Mucaji P, Miadokova E. 2014. Extract from Armoracia rusticana and its flavonoid components protect human lymphocytes against oxidative damage induced by hydrogen peroxide. Molecules 19:3160–3172
  • Ganesan A. 2008. The impact of natural products upon modern drug discovery. Curr Opin Chem Biol 12:306–317
  • Harvey AL. 2008. Natural products in drug discovery. Drug Discov Today 13:894–901
  • Health Canada. Policy paper-Nutraceuticals/functional foods and health claims on foods Available at: http://www.hc-sc.gc.ca/fn-an/labeletiquet/claims-reclam/nutra funct foods nutrafonctalimeneng.php. Accessed on 24 June 2013
  • Hernández-Abreu O, Torres-Piedra M, García-Jiménez S, Ibarra-Barajas M, Villalobos-Molina R, Montes S, Rembao D, Estrada-Soto S. 2013. Dose-dependent antihypertensive determination and toxicological studies of tilianin isolated from Agastache mexicana. J Ethnopharmacol 146:187–191
  • Hsieh CY, Santell RC, Haslam SZ, Helferich WG. 1998. Estrogenic effects of genistein on the growth of estrogen receptor-positive human breast cancer (MCF-7) cells in vitro and in vivo. Cancer Res 58:3833–3838
  • Huang MQ, Xu W, Wu SS, Lu JJ, Chen XP. 2013. A 90-day subchronic oral toxicity study of triterpene-enriched extract from Alismatis Rhizoma in rats. Food Chem Toxicol 58:318–323
  • International Conference on Harmonization (ICH). ICH M3(R2): guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization. Current Step 4 version dated 11 June 2009
  • International Conference on Harmonization (ICH). ICH S2(R1): guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use Current Step 4 version dated 9 November 2011
  • International Conference on Harmonization (ICH). ICH S7A: safety pharmacology studies for human pharmaceuticals. Current Step 4 version dated 8 November 2000
  • International Conference on Harmonization (ICH). ICH S7B: guidance for repeated dose tissue distribution studies. Current Step 4 version dated 27 October 1994
  • Japanese Ministry of Health, Labour and Welfare. Available at: http://www.mhlw.go.jp/english/index.html. Accessed on 26 November 2014
  • Jones PJ. 2002. Clinical nutrition: 7. Functional foods more than just nutrition. Can Med Assoc J 166:1555–1563
  • Ju YH, Carlson KE, Sun J, Pathak D, Katzenellenbogen BS, Katzenellenbogen JA, Helferich WG. 2000. Estrogenic effects of extracts from cabbage, fermented cabbage, and acidified brussels sprouts on growth and gene expression of estrogen-dependent human breast cancer (MCF-7) cells. J Agric Food Chem 48:4628–4634
  • Ju YH, Doerge DR, Woodling KA, Hartman JA, Kwak J, Helferich WG. 2008. Dietary genistein negates the inhibitory effect of letrozole on the growth of aromatase-expressing estrogen-dependent human breast cancer cells (MCF-7Ca) in vivo. Carcinogenesis 29:2162–2168
  • Ju YH, Fultz J, Allred KF, Doerge DR, Helferich WG. 2006. Effects of dietary daidzein and its metabolite, equol, at physiological concentrations on the growth of estrogen-dependent human breast cancer (MCF-7) tumors implanted in ovariectomized athymic mice. Carcinogenesis 27:856–863
  • Katchy A, Pinto C, Jonsson P, Nguyen-Vu T, Pandelova M, Riu A, Schramm KW, et al. 2014. Coexposure to phytoestrogens and bisphenol a mimics estrogenic effects in an additive manner. Toxicol Sci 138:21–35
  • Kim J1, Um SJ, Woo J, Kim JY, Kim HA, Jang KH, Kang SA, et al. 2005. Comparative effect of seeds of Rhynchosia volubilis and soybean on MG-63 human osteoblastic cell proliferation and estrogenicity. Life Sci 78:30–40
  • Kingston DG, Newman DJ. 2005. Natural products as drug leads: an old process or the new hope for drug discovery? Idrugs 8:990–992
  • Kothari SC, Shivarudraiah P, Venkataramaiah SB, Gavara S, Arumugam SN, Soni MG. 2014. Toxicologic evaluation of Dichrostachys glomerata extract: subchronic study in rats and genotoxicity tests. Food Chem Toxicol 69:120–131
  • Kothari SC1, Shivarudraiah P, Venkataramaiah SB, Gavara S, Soni MG. 2012. Subchronic toxicity and mutagenicity/genotoxicity studies of Irvingia gabonensis extract (IGOB131). Food Chem Toxicol 50:1468–1479
  • Kothari SC1, Shivarudraiah P, Venkataramaiah SB, Koppolu KP, Gavara S, Jairam R, Krishna S, et al. 2011. Safety assessment of Cissus quadrangularis extract (CQR-300): subchronic toxicity and mutagenicity studies. Food Chem Toxicol 49:3343–3357
  • Kris-Etherton PM, Harris WS, Appel LJ; American Heart Association. Nutrition Committee. 2002. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation 106:2747–2757
  • Lee HS, Park EJ, Oh JH, Moon G, Hwang MS, Kim SY, Shin MK, et al. 2014. Bisphenol A exerts estrogenic effects by modulating CDK1/2 and p38 MAP kinase activity. Biosci Biotechnol Biochem 78:1371–1375
  • Lomnitski L, Padilla-Banks E, Jefferson WN, Nyska A, Grossman S, Newbold RR. 2003. A natural antioxidant mixture from spinach does not have estrogenic or antiestrogenic activity in immature CD-1 mice. J Nutr 133:3584–3587
  • Lu L, Fan Y, Yao W, Xie W, Guo J, Yan Y, Yang F, Xu L. 2014. Safety assessment of the fermented Phylloporia ribis (Lonicera japonica Thunb.) mycelia by oral acute toxicity study in mice and 90-day feeding study in rats. Food Chem Toxicol 69:18–24
  • Lynch B1, Lau A, Baldwin N, Bauter MR, Marone PA. 2013. Subchronic and reproductive toxicity of whole dried Hoodia parviflora aerial parts in the rat. Food Chem Toxicol 56:313–324
  • Monção NB, Costa LM, Arcanjo DD, Araújo BQ, Lustosa Mdo C, Rodrigues KA, Carvalho FA, et al. 2014. Chemical constituents and toxicological studies of leaves from Mimosa caesalpiniifolia Benth., a Brazilian honey plant. Pharmacogn Mag 10(suppl 3):S456–S462
  • Natarajan R, Lanting L, Xu L, Nadler J. 1994. Role of specific isoforms of protein kinase C in angiotensin II and lipoxygenase action in rat adrenal glomerulosa cells. Mol Cell Endocrinol 101:59–66
  • National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). 2012. Draft Validation Study Report MCF-7 Cell Proliferation test Method. June 18, 2012
  • Nielsen TS, Nørgaard JV, Purup S, Fretté XC, Bonefeld-Jørgensen EC. 2009. Estrogenic activity of bovine milk high or low in equol using immature mouse uterotrophic responses and anestrogen receptor transactivation assay. Cancer Epidemiol 33:61–68
  • Nunes Rda S, Kahl VF, Sarmento Mda S, Richter MF, Abin-Carriquiry JA, Martinez MM, Ferraz Ade B, Da Silva J. 2013. Genotoxic and antigenotoxic activity of acerola (Malpighia glabra L.) extract in relation to the geographic origin. Phytother Res 27:1495–1501
  • Okazaki K, Okazaki S, Nakamura H, Kitamura Y, Hatayama K, Wakabayashi S, Tsuda T, et al. 2002. A repeated 28-day oral dose toxicity study of genistein in rats, based on the ‘Enhanced OECD Test Guideline 407’ for screening endocrine-disrupting chemicals. Arch Toxicol 76:553–559
  • Okubo T, Suzuki T, Yokoyama Y, Kano K, Kano I. 2003. Estimation of estrogenic and anti-estrogenic activities of some phthalate diesters and monoesters by MCF-7 Cell Proliferation Assay in vitro. Biol Pharm Bull 26:1219–1224
  • Organisation for Economic Cooperation & Development (OECD). 1998. Series on Principles of Good Laboratory Practice and Compliance Monitoring. Number 1: OECD Principles on Good Laboratory Practice. ENV/MC/CHEM (98) 17
  • Organisation for Economic Cooperation & Development (OECD), 2012. Test No. 457. BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and Antagonists. October 2012
  • Petrakis NL, Barnes S, King EB, Lowenstein J, Wiencke J, Lee MM, Miike R, et al. 1996. Stimulatory influence of soy protein isolate on breast secretion in pre- and postmenopausal women. Cancer Epidemiol Biomarkers Prev 10:785–794
  • Programa de Cumplimiento de las Buenas Prácticas de Laboratorio. Elaborado por: Grupo de Buenas Prácticas de Laboratorio (BPL). Aprobado por: Comité Técnico de Inspección (CTI). 17 de junio de 2014 Código: CTI/BPL/026/03/14 Fecha publicación en web www.aemps.gob.es: 30 de junio de 2014
  • Punt A, Brand W, Murk AJ, van Wezel AP, Schriks M, Heringa MB. 2013. Effect of combining in vitro estrogenicity data with kinetic characteristics of estrogenic compounds on the in vivo predictive value. Toxicol In Vitro 27:44–51
  • Real Decreto 53/2013, de 1 de febrero, por el que se establecen las normas básicas aplicables para la protección de los animales utilizados en experimentación y otros fines científicos, incluyendo la docencia. Boletín Oficial del Estado, No. 34. Sec. I, 08.02.2013, p. 11370–11421
  • Regulation (CE) No. 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. OJ L 404, 30.12.2001, p. 9–25
  • Sabini MC, Cariddi LN, Escobar FM, Mañas F, Comini L, Reinoso E, Sutil SB, et al. 2013. Evaluation of the cytotoxicity, genotoxicity and apoptotic induction of an aqueous extract of Achyrocline satureioides (Lam.) DC. Food Chem Toxicol 60:463–470
  • The European Medicines Agency (EMA). Available at: http://www.ema.europa.eu/ema/. Accessed on 27 November 2014
  • The Organisation for Economic Co-operation and Development (OECD). Available at: http://www.oecd.org/. Accessed on 27 November 2014
  • The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Available at: http://www.ich.org/. Accessed on 27 November 2014
  • US Food and Drug Administration (FDA). Available at: http://www.fda.gov/. Accessed on 27 November 2014
  • Van Duursen MB, Smeets EE, Rijk JC, Nijmeijer SM, van den Berg M. 2013. Phytoestrogens in menopausal supplements induce ER-dependent cell proliferation and overcome breast cancer treatment in an in vitro breast cancer model. Toxicol Appl Pharmacol 269:132–140
  • Visser K1, Mortimer M, Louw A. 2013. Cyclopia extracts act as ERα antagonists and ERβ agonists, in vitro and in vivo. PLoS One 8:e79223
  • Wang S, Zhu F, Meckling KA, Marcone MF. 2013. Antioxidant capacity of food mixtures is not correlated with their antiproliferative activity against MCF-7 breast cancer cells. J Med Food 16:1138–1145
  • WHO/IPCS. 2002. Global assessment of the state of the science of endocrine disruptors. International Programme on Chemical Safety. Geneva: WHO. Available at: http://www.who.int/ipcs/publications/en/toc.pdf. Accessed on 01 December 2014
  • Zan MA, Ferraz AB, Richter MF, Picada JN, de Andrade HH, Lehmann M, Dihl RR, et al. 2013. In vivo genotoxicity evaluation of an artichoke (Cynara scolymus L.) aqueous extract. J Food Sci 78:T367–T371
  • Zou S, He X, Liu Y, Chen D, Luo Y, Huang K, Zhang W, Xu W. 2014. Toxicological evaluation of lactase derived from recombinant Pichia pastoris. PLoS One 9:e106470

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.