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“The Dose Makes the Poison”: Rethinking Traditional Toxicity Testing

drops into test tubesStory Highlights
  • “The dose makes the poison” is a core assumption underlying traditional toxicity testing.
  • It assumes that the greater the dose, the greater the effect.
  • Research on hormone disrupting chemicals shows that repeated low exposures to chemicals leads to adverse affects on human health.

At some point we have all heard the argument “the dose makes the poison” in support of the safety of including small amounts of dangerous ingredients such as formaldehyde, phenol, sodium borate, aluminum, etc., in vaccines, but it is not that simple.

Research on the safety of vaccine ingredients, for example, largely ignores contemporary toxicological perspectives on the long-term effects of repeated periodic exposures to low concentrations of dangerous substances. Understanding the basics of chemical-safety testing methods is the first step to understanding how the toxicity of a substance is measured.

“The Dose Makes the Poison”: A Core Assumption of Traditional Toxicology

Toxicology is the study of adverse effects in living organisms following exposure to chemicals.1 Toxicity is essentially the degree to which a substance is considered to be poisonous to living beings.2 Toxicology involves safety testing of environmental agents found in nature and chemical agents used in food, drinking water and synthetic pharmaceutical products.1

Traditionally, the idea that “the dose makes the poison” has been the core assumption on which toxicology testing has been based.1 Swiss German physician, Paracelsus (14931541), sometimes known as the father of toxicology theorized that,3 “All things are poison and nothing (is) without poison; the dose alone makes a thing not poison.”4 The implication underlying this assumption is that exposure to larger doses of any particular chemical will result in a greater risk of toxic effects.5

In other words, low exposures to chemicals are considered to be insignificant.6 For example, a small amount of caffeine in a normal human diet does not necessarily cause illness but consuming 50 times this amount could be poisonous.2

Given that this core assumption makes logical sense, it is therefore used as a basis for regulatory toxicity testing to identify maximum acceptable concentrations of contaminants in food, water, the environment, drugs, etc.2 John Peterson Myers, PhD, co-founder, CEO and chief scientist at Environmental Health Sciences and an author of Our Stolen Future explains how toxicology tests are used to develop health standards:

Government agencies identify and regulate dangerous substances assuming that ‘the dose makes the poison’. To set exposure limits, three to five doses of a substance are tested in the laboratory. Toxicologists start at the highest dose chosen and continue to lower doses until they find the point where effects are no longer detectable, that is, the dose at which experimental animals no longer differ from controls. This safe dose—the lowest amount that poses an acceptable risk—is called the ‘no observed adverse effect level,’ or NOAEL. Traditional toxicology guiding health regulations rarely tests doses lower than NOAEL due to the ‘dose makes the poison’ assumption.5

In essence, traditional toxicity testing only assesses acute, short-term toxicity of a substance through experiments that expose laboratory animals to various doses of the chemical being tested. It does not measure whether periodic exposure to a chemical is safe over a period of several years.2

Research on Endocrine Disruptors Challenges Toxicology’s Core Assumption

Although a linear relationship between dose and toxicity is widely accepted in that, as the dose increases, so does the effect, research on endocrine disrupting compounds challenges this assumption.1 4 5 For many decades, low exposures to endocrine disrupting chemicals have been shown to result in detrimental health effects. 7 8

A 2012 report based on a review of 800 scientific studies published in the journal Endocrine Reviews provides clear evidence indicating that exposure to very to small amounts of hormone disrupting chemicals has profound, adverse effects on human health at all stages of life.7 The authors state:

Whether low doses of endocrine disrupting chemicals influence certain human disorders is no longer conjecture, because epidemiological studies show that environmental exposures to EDCs are associated with human diseases and disabilities.7

The report discusses exposures to chemicals such as bisphenol A (used in plastics, can liners, receipt paper), common pesticides such as atrazine, methyl paraben (used in cosmetics) and triclosan (antibacterial used in toothpaste.9

Findings from this paper challenge the traditional dogma in toxicology—the dose makes the poison.7 8 They authors argue:

Current testing paradigms are missing important, sensitive endpoints… they cannot make appropriate predictions about what effects are occurring at low doses. At this time, it is not possible to quantify the total costs of low-dose exposures to endocrine disrupting chemicals.”7

This concept is no different when applied to vaccine ingredients. While small concentrations of particular chemicals used in vaccines may not necessarily lead to acute short-term health effects, chronic long-term effects of repeated exposure (49 doses of 14 vaccines by the age of 6) to small amounts of the ingredients have not been thoroughly studied.

Measuring the toxicity of a chemical is much more complex than simply arguing “the dose makes the poison.” It depends on several factors, including the avenue through which it enters the body, how it may get metabolized through biological processes into other chemical forms, whether it gets excreted from the body or stored in the body’s organs and its overall cumulative effects over a period of time.2 Director of the National Institute of Environmental Health Sciences, Linda Birnbaum puts it this way:

Industry is still asking ‘old questions’ about chemical safety even though science has moved on.8


1 Smith Y. What is Toxicology? News Medical June 4, 2015
Trautmann N. The Does Makes The Poison–Or Does It? ActionBioscience.org January 2005.
Borzelleca J. Paracelsus: Herald of Modern Toxicology. Toxicological Sciences 2000; 53: 2-4.
Fagin D. Toxicology: The Learning Curve. Nature 2012; 490: 462-465.
5 Meyers P, Hessler W. Does “the dose make the poison?”–Extensive Results Challenge A Core Assumption in Toxicology OurStolenFuture.org May 25, 2007.
Colburn T, Dumanoski D, Myers JP. Does “the Dose Make the Poison”? OurStolenFuture.org.
Vandenberg L, Colborn T, Hayes T, Heindel J, Jacobs D, Lee D, Shioda T, Soto A, Vom Saal F, Welshons W, Zoeller T, Myers JP. Hormone and Endocrine Disrupting Chemicals: Lose Dose Effects and Nonmonotonic Dose Responses. Endocrine Reviews 2012; 33 (3): 378 -455.
Cone M. Low doses, big effects: Scientists seek ‘fundamental changes’ in testing, regulation of hormone-like chemicals. Environmental Health News Mar. 15, 2012.
Grossman E. Scientists Warn of Low-Dose Risks of Chemical Exposure. Yale Environment 360 Mar. 19, 2012.

6 Responses to “The Dose Makes the Poison”: Rethinking Traditional Toxicity Testing

  1. Mostafa Reply

    May 10, 2016 at 5:49 am

    Are repeating of flu vaccine yearly yield toxicity results of accumulating of added ingredients ?

  2. Thomas A Braun RPh Reply

    May 10, 2016 at 7:36 am

    Thank you for the affirmation! I have been expressing this view for years. The FDA is not looking at the cumulative effect of trace toxins on the human body. Disease states are expanding due to the ever increasing accumulation of trace toxins from our processed food supply, the environment and drugs we consume. Our liver has limited capacity to detoxify when inundated.
    My motto is N2E+ for Life. Good nutrition without toxins, nutrient supplementation for deficiencies, exercise PLUS a stress free life style. We have to recognize we are a chemical society and must start rejecting the over exposure. I’m particular concerned about mothers to be and their prenatal care or lack of it. That’s why I support “Protect our Kids NOW! initiative by http://www.grassrootshealth.net Come and join us!

  3. Nancy Reply

    May 10, 2016 at 10:41 am

    The whole thing is so convoluted. Even testing substances on animals is crazy. Using a living being for testing of toxic substances is cruel and many animals respond differently to these substances then humans. Imagine if they had tested chocolate on dogs first, we would not be eating it.

  4. D. Smith Reply

    May 10, 2016 at 12:55 pm

    The only place the dose should be an issue is in the work of homeopathy. The medical industry uses dose as a crutch on which to lean when they need an excuse for the atrocities they’ve been perpetrating on the public for decades. When the medical industry comes to terms with the fact that we do not all fit into just one box (read: we are not all the same and will not react the same) we may make progress in the doling out of less pills and potions, which would truly be progress. The fact that this is effecting the entire citizenry from birth to death (however it comes about) should be a clue to them, but they are obviously more interested in money than health, thus calling it “healthcare” is the biggest oxymoron on earth.

  5. Alix Fano Reply

    May 10, 2016 at 7:54 pm

    I wrote about this issue in my 1997 book, Lethal Laws: Animal Testing, Human Health and Environmental Policy. I devote an entire Chapter (Chapter 3) to discussing the biological differences between test animals used in toxicology tests (largely rodents) and humans. I describe the complex mathematical formulas used to extrapolate controversial animal-based “safety doses” to humans. I expose the antiquated regulatory system that has failed to keep up with technological advances. I show how animal data have yielded erroneous results that have allowed dangerous chemicals to stay on the market, to the benefit of the chemical industry. And I devote an entire Chapter (Chapter 5) to an exploration of the many cheap, reliable testing methods that exist which could replace animal tests, and which are being used in many progressive toxicology labs today.

  6. APV Reply

    May 10, 2016 at 8:18 pm

    Vaccines cause the development of food allergies: the latest evidence

    Drs. Commins and Platts-Mills were the first to describe tick bites causing red meat allergy.[1⁠]

    A case of a naturally injected allergen causing the development of allergy.

    Vaccines of course are artificial injections of food allergens, causing the development of food allergies.[2]⁠

    The same team above, now describes their findings regarding food allergy and vaccination.

    Changes in IgE Levels Following One-Year Immunizations in Two Children with Food Allergy


    Case 1 in the above study

    “Case 1: At 8 months-old, her serum IgE values (in IU/mL) were total 61.4, peanut 13.6, almond 4.04, milk 3.84, egg 2.01, soy 1.6, and wheat 0.98, compared to total 44.1, peanut 11.2, almond 1.54, milk 2, egg 1.71, soy 1.62, and wheat 2.2 at 12 months-old. After the 12 month-old labs were drawn, she received the vaccines Prevnar13, hepatitis A, MMR, and Varicella. 3 weeks later, at 12.7 months-old, her IgE values were total 75.6, peanut 16.5, almond 2.18, milk 5.06, egg 3.4, soy 3.64, and wheat 3.75.”

    The vaccines caused increases in peanut, almond, milk, egg, soy and wheat IgE.

    Let’s look at the food proteins contaminating the vaccines the patient received.[3⁠]

    Prevnar 13 contains casamino acids (cow’s milk derived) and soy peptone broth.

    Polysorbate 80 from EMD Millipore may contain wheat proteins.

    Polysorbate 80 is present in many vaccines including Prevnar 13.



    “The following materials are used as raw material but are not present in the final product: Maize, Wheat

    We point out that we do not perform any testing on allergens in the above-mentioned product.”

    Polysorbate and other excipients derived from vegetable sources are present in many other vaccines and most suppliers do not have allergen information. So polysorbate and other excipients could also be a source of peanut and almond protein contamination of vaccines.

    MMR contains chick embryo culture proteins and the vaccine package insert [4]⁠ has a warning for patients with egg allergy. Some egg proteins may be common to or cross react with chick embryo proteins.

    Case 2 in the above study

    “Case 2: At 12 months-old, the boy’s IgE values were total 21.1, egg 1.16, and peanut, milk, wheat, soy, cod, and shrimp <0.1. A week later, he received Prevnar13, MMR, and Varicella. 3 weeks later, at 13 months-old, his IgE values were total 23.8, egg 4.02, and peanut, milk, wheat, soy, cod, and shrimp <0.35 “

    For case 2, again, MMR could have been the cause of the increase in egg IgE.

    Clear evidence that food proteins in vaccines turn them into food allergy booster shots that boost the severity of food allergies. Children are taking longer to outgrow allergies. [5⁠] How can they outgrow their food allergies, if we insist on giving them food allergy booster shots?

    This latest evidence adds to the solid body of scientific evidence,[2⁠] demonstrating a causal relationship between food protein contaminated vaccines and the development of food allergies.


    1. Commins SP, Platts-Mills T a E. Allergenicity of carbohydrates and their role in anaphylactic events. Curr Allergy Asthma Rep. 2010;10(1):29–33.

    2. Arumugham V. Evidence that Food Proteins in Vaccines Cause the Development of Food Allergies and Its Implications for Vaccine Policy. J Dev Drugs. 2015;4(137):2.

    3. Vaccine Excipient & Media Summary [Internet]. 2015 [cited 2016 Jan 16]. Available from: http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

    4. MMR II Vaccine Package Insert [Internet]. [cited 2016 May 3]. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM123789.pdf

    5. Wang J. Management of the patient with multiple food allergies. Curr Allergy Asthma Rep. 2010;10(4):271–7.

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