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Safety and Toxicity Evaluation of Nutraceuticals in Animal Models

  • Nikolay Goncharov
  • Vladislav Sobolev
  • Maxim Terpilowski
  • Ekaterina Korf
  • Richard Jenkins
Chapter

Abstract

Nutraceuticals are derived from various natural sources such as medicinal plants, marine organisms, vegetables, and fruits. Most of them possess antioxidant or anti-inflammatory properties and are claimed to provide protection against many diseases if taken regularly. At the same time, toxicological studies of nutraceuticals have been limited, so the safety of many of them cannot be guaranteed. Animals share many genetic, anatomical, and physiological similarities with humans, and they continue to be widely used in preclinical studies of drugs, in spite of a lack of their validity which is due to the great phenotypic differences. The absence of toxicity in animals provides little probability that adverse reactions will also be absent in humans. There are currently thousands of researchers involved in the development of alternatives to animal use in the life sciences. Statistical machine-learning tools, once developed, might become a powerful means to explain the complex physiological effects of nutraceuticals. The use of different models and algorithms can provide a more scientific basis for risk assessment of nutraceuticals for humans.

Keywords

Preclinical studies Biomarkers System analysis Alternative models Cytotoxic power 

Abbreviations

ADI

Acceptable daily intake

ADRs

Adverse drug reactions

ALA

α-linolenic acid

ARRIVE

Animals in Research: Reporting In Vivo Experiments

BMD

Benchmark dose

BMDL

Benchmark dose lower bound

CDDs

Chlorinated dibenzo-p-dioxins

DHA

Docosahexaenoic acid

DNEL

Derived no-effect level

DSHEA

Dietary Supplement Health and Education Act

EDI

Estimated daily intake

EGCG

(−)-epigallocatechin-3-gallate

EPA

Eicosapentaenoic acid

ETs

Ellagitannins

GRAS

Generally recognized as safe

GTE

Green tea extract

HBA

Harm-benefit analysis

LOAEL

Lowest-observed-adverse-effect level

LRs

Likelihood ratios

MOA

Mode of action

MOE

Margin of exposure

NHPs

Nonhuman primates

NOAEL

No-observed-adverse-effect level

OSC

Organosulfur compounds

PARNUTS

Particular nutritional uses

PAs

Pyrrolizidine alkaloids

PFS

Plant food supplement

PODs

Points of departure

RfC

Reference concentration

RfD

Reference dose

ROS

Reactive oxygen species

RPF

Relative potency factors

RYR

Red yeast rice

TEFs

Toxic equivalency factors

TTC

Threshold of toxicological concern

Notes

Acknowledgment

This work has been supported by the Russian Foundation for Basic Research Grant 18-015-00304 and by the Russian FASO Programme АААА-А18-118012290142-9.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Nikolay Goncharov
    • 1
    • 2
  • Vladislav Sobolev
    • 1
  • Maxim Terpilowski
    • 2
  • Ekaterina Korf
    • 2
  • Richard Jenkins
    • 3
  1. 1.Research Institute of Hygiene, Occupational Pathology and Human EcologyLeningrad RegionRussia
  2. 2.Sechenov Institute of Evolutionary Physiology and BiochemistrySt. PetersburgRussia
  3. 3.School of Allied Health SciencesDe Montfort UniversityLeicesterUK

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