Toxicology testing, also known as safety assessment, or toxicity testing, is the process of determining the degree to which a substance of interest negatively impacts the normal biological functions of an organism, given a certain exposure duration, route of exposure, and substance concentration. Toxicology testing is often conducted by researchers who follow established toxicology test protocol for a certain substance, mode of exposure, exposure environment, duration of exposure, or for a particular organism of interest, or for a particular developmental stage of interest. Toxicology testing is commonly conducted during

preclinical development In drug development, preclinical development, also termed preclinical studies or nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and dru ...

for a substance intended for human exposure. Stages of ''in silico'', ''in vitro'' and ''in vivo'' research are conducted to determine safe exposure doses in model organisms. If necessary, the next phase of research involves human toxicology testing during a

first-in-man study The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phas ...

. Toxicology testing may be conducted by the

pharmaceutical industry The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. ...

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used ...

companies,

contract research organizations In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may prov ...

, or environmental scientists.

History

Europe

Around one million animals, primate and non–primate, are used every year in Europe in toxicology tests. In the UK, one-fifth of animal experiments are toxicology tests.Select Committee on Animals in Scientific Procedures Report
House of Lords, Chapter 3: The purpose and nature of animal experiments. Animal testing for cosmetic purposes is currently banned all across the

European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are located primarily in Europe, Europe. The union has a total area of ...

Methodology

Toxicity tests examine finished products such as

pesticide Pesticides are substances that are meant to control pests. This includes herbicide, insecticide, nematicide, molluscicide, piscicide, avicide, rodenticide, bactericide, insect repellent, animal repellent, microbicide, fungicide, and ...

medication A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...

cosmetics Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin care can be used to cleanse or protec ...

food additives Food additives are substances added to food to preserve flavor or enhance taste, appearance, or other sensory qualities. Some additives have been used for centuries as part of an effort to preserve food, for example vinegar (pickling), salt (sal ...

such as

artificial sweetener A sugar substitute is a food additive that provides a sweetness like that of sugar while containing significantly less food energy than sugar-based sweeteners, making it a zero-calorie () or low-calorie sweetener. Artificial sweeteners may b ...

s, packing materials, and

air freshener Air fresheners are consumer products that typically emit fragrance and are used in homes or commercial interiors such as restrooms, foyers, hallways, vestibules and other smaller indoor areas, as well as larger areas such as hotel lobbies, auto d ...

, or their chemical ingredients. The substances are tested using a variety of methods including dermal application, respiratation, orally, injected or in water sources. They are applied to the skin or eyes; injected

intravenous Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein. The intravenous route of administration is commonly used for rehydration or to provide nutrie ...

ly,

intramuscular Intramuscular injection, often abbreviated IM, is the injection of a substance into a muscle. In medicine, it is one of several methods for parenteral administration of medications. Intramuscular injection may be preferred because muscles ha ...

ly, or subcutaneously; inhaled either by placing a mask over the animals, or by placing them in an inhalation chamber; or administered orally, placing them in the animals' food or through a tube into the stomach. Doses may be given once, repeated regularly for many months, or for the lifespan of the animal. Toxicity tests can also be conducted on materials need to be disposed such as sediment to be disposed in marine environment. Initial toxicity tests often involve computer modelling (in silico) to predict toxicokenetic pathways or to predict potential exposure points by modelling weather and water currents to determine which animals or regions that will be most affected. Other less intensive and more common tests involve microtox assay's to observe bacteria growth and productivity. This can be adapted to plant life measure photosynthesis levels and growth of exposed plants.

Contract research organizations

A contract research organization (CRO) is an organization that provides support to the

pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...

, chemical, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide toxicity testing services, along with others such as assay development, preclinical research,

clinical research Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treat ...

, clinical trials management, and pharmacovigilance. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH,

EMEA EMEA is a shorthand designation meaning Europe, the Middle East and Africa. The acronym is used by institutions and governments, as well as in marketing and business when referring to this region: it is a shorthand way of referencing the two ...

, etc.)."The CRO Market"
Association of Clinical Research Organizations.

Regulation

United States

In the United States, toxicology tests are subject to

Good Laboratory Practice In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality ...

guidelines and other

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

laws.

References

External links

What is aquatic toxicity testing?

Safety Assessment, Animal Research Laboratories Agency.
emka TECHNOLOGIES
Physiological data acquisition & analysis for preclinical research {{Authority control Animal testing Tests Toxicology