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Safety and Toxicity Evaluation of Nutraceuticals in Animal Models

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Nutraceuticals in Veterinary Medicine

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.

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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

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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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Authors and Affiliations

  1. Research Institute of Hygiene, Occupational Pathology and Human Ecology, Leningrad Region, Russia

    Nikolay Goncharov & Vladislav Sobolev

  2. Sechenov Institute of Evolutionary Physiology and Biochemistry, St. Petersburg, Russia

    Nikolay Goncharov, Maxim Terpilowski & Ekaterina Korf

  3. School of Allied Health Sciences, De Montfort University, Leicester, UK

    Richard Jenkins

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  1. Nikolay Goncharov
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Editors and Affiliations

  1. Department of Toxicology, Breathitt Veterinary Center, Murray State University, Hopkinsville, KY, USA

    Ramesh C. Gupta

  2. Vets Plus Inc., University of Wisconsin–Stout, Menonomie, WI, USA

    Ajay Srivastava

  3. Vets Plus Inc., Menomonie, WI, USA

    Rajiv Lall

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Goncharov, N., Sobolev, V., Terpilowski, M., Korf, E., Jenkins, R. (2019). Safety and Toxicity Evaluation of Nutraceuticals in Animal Models. In: Gupta, R., Srivastava, A., Lall, R. (eds) Nutraceuticals in Veterinary Medicine. Springer, Cham. https://doi.org/10.1007/978-3-030-04624-8_48

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