Product Testing

AV magazine issue 2, 2010 2010 Issue #2 Consumer Power for Animals Product Testing:
Beginning to an End?

Crystal Schaeffer MA ED., MA IPCR, is the Outreach Director for AAVS.

Most of us have a nightly routine before we go to bed. We may brush our teeth, for example, and not give this task a second thought. We close our eyes, fall asleep, and dream, thinking nothing of the nightmare that any number of animals might have endured to enhance our lives.

IT IS AN UNFORTUNATE REALITY: animals, including rabbits and guinea pigs, who are the same as our pets at home in nearly every way except for their circumstances, still suffer needlessly in the production of personal care and household products. Their use in testing the safety of products like toothpaste, dish soap, and floor cleaner is based in part on an outdated theory that animal responses in a lab will accurately predict what will happen when humans are exposed to the same substances. However, this is a flawed model because physiology varies among different animal species, including humans. Therefore, reactions may be quite different from one species to another. And importantly, purposefully exposing animals to substances that can potentially harm them, especially when information resources and non-animal testing methods exist, is not only wasteful science but ethically problematic.

Prior to the 1930s, little regulation existed for the sale of personal care products. Companies were not required to vouch for the safety or reliability of their manufactured goods, giving opportunity for instances of not only quackery, but also serious human injury and even death. For example, more than a dozen women were blinded after applying a permanent mascara called Lash Lure, which contained p-phenylenediamine, a derivative of coal tar, that caused terrible blisters on their faces, eyelids, and eyes. In one case, abscesses were so severe that a woman contracted an infection and died.[1] In another case, a hair dye called Inecto Rapid Notox created a painfully itchy, scaly scalp for 37 people who used it.[2]

As similar cases emerged, the federal government moved to scrutinize the industry more readily, and in 1938, the Food, Drug, and Cosmetic (FD&C) Act became law, giving the Food and Drug Administration (FDA) regulatory authority over the cosmetics industry, formally authorizing factory inspections, and requiring drugs to be shown safe before they are marketed.[3] Some years later, the FDA was instrumental in initiating the development of animal testing techniques, and in 1944, assigned agency researcher John Draize to craft a standardized method for testing the irritancy of substances. Named after its creator, the Draize test involves placing a substance in the eyes or on the skin of often unanaesthetized animals, usually rabbits, over a specific period of time (hours, days, or weeks). Lab workers assess the condition of the animals and assign a subjective numerical score to indicate the severity of manifesting injury, which can include inflammation, discharge, hemorrhage, and ulceration.[4] Animals are commonly killed at the end of the tests.

Over several decades, the use of Draize tests, as well as other animal-based tests, became widely accepted within the science, regulatory, and industry communities. However, the unnecessary cruelty of these tests was exposed in the 1980s, and outraged consumers began coordinated efforts to protest animal testing. Led by Henry Spira, a highly adept social activist, a campaign against cosmetic giant Revlon was developed to combat its use of the Draize. The campaign focused on consumer demand and a push for the development and use of alternative testing methods. As a result, Revlon agreed to donate a large sum of money to support non-animal safety research at Rockefeller University,[5] and a wave of alternatives development began to emerge.

For the most part, cosmetic finished products and mild household cleaners are no longer tested on animals. However, their individual ingredients and/or formulations often are. Nonetheless, whether lipstick or floor cleaner, the testing methods remain virtually the same (especially in countries with emerging economies) and they are just as invasive, painful, and cruel.

Below is a list of some of the tests most commonly used today by the cosmetic ingredient and household product industries.

Eye Irritancy and Corrosivity
The Draize eye test uses restrained rabbits who have a substance placed in one eye, with the other eye serving as a control. Animals are evaluated after one hour and then at 24-hour intervals for up to 14 days, and redness, bleeding, ulcers, and even blindness can occur.

Skin Irritancy and Corrosivity
The Draize skin test assesses the potential of a substance to cause irreversible damage to the skin, itching, swelling, and inflammation, and is typically performed on rabbits. It involves placing a chemical on a shaved patch of skin and using another shaved patch as a control. Alternatives have been validated to replace the majority of these tests.

For years the primary choice to measure acute toxicity was the Lethal Dose 50 (LD50), which determined the dose at which at least 50 percent of test animals died. However, especially for cosmetic and household products, the LD50 has been replaced by several new, but still lethal, options. Among them, the acute toxic class method and the up-and-down procedure, both of which involve a smaller number of animals but can cause excruciating pain, convulsions, loss of motor function, and/or uncontrollable seizures. In the fixed dose method, death is not used as an endpoint and signs of suffering will usually terminate the test. In repeated dose toxicity testing, chronic toxic effects are analyzed, with a focus on organ systems, and doses that do not cause an observed effect are measured. Toxicity tests typically use rats and mice, as well as rabbits.

Skin Sensitization
The most common skin sensitization test used now is the Local Lymph Node Assay, which involves the application of test chemicals on the surface of the ears of mice, and is considered a validated alternative to traditional methods using guinea pigs because it reduces the number of animals used and limits pain and distress. However, mice are still killed when testing is complete.

Dermal Penetration
This analyzes the movement of a chemical through the skin and into the bloodstream. Rats are most often used, and killed to determine the amount of test substance absorbed.

These tests are utilized to determine the negative effects of chemicals entering the environment. Acute toxicity is determined using fish in the 96-hour LC50 (lethal concentration 50), which measures the chemical concentration that will kill 50 percent of animals in a 96 hour period. Chronic toxicity tests last seven to more than 200 days, and fish are evaluated for growth, hatching and spawning success, and mortality.

Carcinogenicity & Mutagenicity
In carcinogenicity testing, a chemical is administered orally, topically, or inhaled during a two-year duration, and animal health is monitored throughout the study, but most information is obtained after the animals are killed and their tissues and organs are examined for evidence of cancer. To test for mutagenicity, a substance is administered to animals, who are later killed, and their bone marrow is evaluated to determine the presence of mutation, which can cause cancer. Rats and mice are typically used in these tests.

Although their historical acceptance has been widespread, no existing animal-based toxicity tests have undergone rigorous validation procedures that might justify the extreme suffering they cause for millions of animals. However, we know that there are problems with applying the test results to people. For example, rabbits, who are often used in irritancy tests, have thinner skin than humans and their eyes do not readily tear like humans. Because of issues like these, animal data cannot routinely demonstrate the important research principles of reliability, relevance, and reproducibility.[6]

Furthermore, while the FDA, which has played a substantial role in developing animal tests, does require manufacturers to be able to demonstrate that their cosmetic products and ingredients are safe, it does not require animal tests to do this.[7] The agency states on its website that scientists should first consider the use of non-animal alternatives, and if animal testing is utilized, research methods should derive "the maximum amount of useful scientific information from the minimum number of animals and employ the most humane methods available…."[8] Additionally, as a member of the Inter-Agency Coordinating Committee for the Validation of Alternative Methods (ICCVAM), FDA also advises that "consideration should be given to the use of scientifically valid alternative methods to whole-animal testing."[9]

In an effort to further the alternatives field, in 1981, the Johns Hopkins Center for Alternatives to Animal Testing was established with a mission to develop the scientific knowledge necessary to create non-animal methods of assessing the safety of cosmetic and household products. Several years later, government supported agencies, ECVAM (European Centre for the Validation of Alternative Methods) in the EU and ICCVAM in the U.S, were created specifically to validate non-animal alternatives that would eventually be formally accepted to replace correlating animal tests. The first in the EU was EPISKIN® and the first in the U.S. was Corrositex®, both replacements for Draize skin irritancy tests.[10]

Consumer demand for cruelty-free products grew in parallel to alternatives development, and resulted in a new niche market in the personal care industry, while also motivating countless companies to end their animal testing. Unfortunately, with this trend came much confusion as to what exactly "cruelty-free" means. To help consumers make informed cruelty-free choices, a group of prominent animal advocacy organizations, including AAVS, launched the Coalition for Consumer Information on Cosmetics (CCIC) in 1996. Its aim is to certify personal care and household product companies that conduct no animal testing at any stage of product development as cruelty-free, and provides consumers the highest level of assurance regarding their compassionate shopping choices.

Another brick in the road to a hopeful end of product testing is the 7th Amendment to the Cosmetic Directive (76/768/EEC), EU legislation that prohibits the sale of finished cosmetic products and ingredients tested on animals, except for products requiring certain selected types of tests. (For more information, see "Product Testing: The Struggle in Europe," page 20.) This prohibition applies to all cosmetic companies selling in the EU, no matter where their country of origin, making the 7th Amendment a truly global initiative that benefits animals and helps to end cosmetic animal testing.

However, within the past decade, government led efforts to test chemicals sold in high volumes may threaten some of this progress. REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) in the EU, and the proposed Safe Chemicals Act in the U.S., are comprehensive efforts to evaluate the safety and environmental impacts of chemicals through a massive battery of new testing. While most of these substances are not ingredients for personal care and household products, some may be, and there is concern that these efforts could negatively impact CCIC-certified and other truly cruelty-free companies that have not tested on animals for several years. It is difficult to predict the number of animals who may be used in these evaluation tests, although estimates for REACH have been as high as 54 million.[11]

Product testing first emerged following a history of fraud and poor safety standards that left consumers misled if not seriously harmed. In an effort to protect the public, use of animals in testing quickly became the status quo, leading to tremendous animal suffering. However, after unmasking the cruelty involved in product testing, outraged consumers demanded change and soon cruelty-free shopping became a quickly growing trend, along with the growth of alternatives development. Today, global regulatory and legislative action have furthered these efforts to eliminate the use of animals in product testing, while consumer safety remains intact.

Fortunately, there is ample opportunity to purchase cruelty-free products like cosmetics, cleaners, and toothpaste. So now, our compassionate nightly routine allows us to sleep with peace of mind, knowing that we have played a role in giving peace to animals.

Sources Cited

[1] United States Food and Drug Administration. (June 18, 2009). History of the FDA: Regulating Cosmetics, Devices, and Veterinary Medicine After 1938. Retrieved April 9, 2008, from
[2] Institute for Laboratory Animal Research (2004). Safety Testing. Science, Medicine, and Animals. Pg. 21. Retrieved April 9, 2008, from
[3] United States Food and Drug Administration. (June 18, 2009). History of FDA: The 1938 Food, Drug, and Cosmetic Act. Retrieved April 9, 2008, from
[4] Curren, Rodger D., & Harbell, John W. (1998). In vitro alternatives for ocular irritation. Environmental Health Perspectives, 109, 486-7.
[5] Feder, Barnaby J. (September 15, 1988). Henry Spira, 71, Animal Rights Crusader. New York Times.
[6] McArdle, John, Ph.D. (Summer 2002). Mantras, Politics, and Regulatory Inertia: the Search for Alternatives to Animal Testing. AV Magazine. Pgs. 2-5.
[7] United States Food and Drug Administration. (April, 5, 2006). Cosmetics. Animal Testing. Retrieved June 1, 2010, from
[8] Ibid.
[9] Ibid.
[10] (May 4, 2010). Table of Validated and Accepted Alternative Methods. Retrieved on June 18, 2010, from
[11] Hartung, Thomas, & Rovida, Costanza. (August, 2009). Chemical regulators have overreached. Nature, 460, 1080-1.

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