Millions of animals suffer and die each year in the testing of cosmetic, personal care, and household products. Companies poison them to death. They shave the animals' skin and expose it to corrosive substances. They place powerful chemicals in animals' eyes. All of this is done just for a "new and improved" cologne, dish-washing detergent, or toothpaste.
While thousands of animals are killed every year in the United States in product tests, there is no law that requires these tests to be done. Many large and small companies have announced moratoriums or an outright end to product tests. However, there are still a few companies that refuse to end the practice. This is surprising because most scientists have come to the conclusion that animal testing is totally inadequate for protecting humans from harmful products.
In the history of biomedical experiments with animals no single subject has created more controversy than that of product testing. The use of animals to test shampoos, soaps, hair sprays, oven cleaners, and laundry detergents has been the focal point of protest from consumers and criticism from the scientific community. Rightly so, as the tests used to "determine safety" are extremely cruel and wildly inaccurate, leaving the public with no assurance that a product is safe and the scientific community with loads of useless data.
The primary tests used to test products for safety are the Lethal Dose 50 (LD50) test and the Draize eye and skin irritancy tests. These methods have comprised the standard set of safety tests for consumer products for more than six decades. In that time little has been achieved in refining the tests or replacing them with appropriate alternatives. This is not because refinements have not been suggested nor alternatives developed. It is because there has been complacency on the part of the scientific community-other than when they have been pressed by those interested in animal protection to make changes.
This article will explain each test and outline a brief history of their development, the development of refinements and alternatives to their use, and some major events in the history of protest against these tests.
The LD50 Test
The LD50 test consists of giving a group of animals a particular substance until half of the group dies. The animals are forced to ingest a substance either by being tube fed, being placed in an inhalation chamber where they must breathe it in, or by having the substance applied to their skin. The procedure can cause severe distress including convulsions, shock, paralysis, and bleeding from their mouths, noses, and anuses.
Originally developed in 1927 by J.W. Trevan the LD50 test was used to determine the potency of digitalis extracts, insulin, and diphtheria antitoxin. Scientists soon developed other methods for determining potency but the LD50 caught on as a "scientific" measure of toxicity. The ease of performing an LD50, as well as the appeal of getting concrete numbers quickly, has made results of the test a standard in toxicology studies. Governments also liked the numerical results that the LD50's provided and quickly mandated the test for assessing the toxic effects of products ranging from pesticides to industrial solvents.
However, the down side to the LD50 test (outside of its extreme cruelty) is that it was considered inadequate for assessing toxicity by a large body of the toxicology community.
Major criticisms of the LD50 test appeared within a decade of its development (both on scientific and ethical grounds), and alternatives to the test were suggested within 5 years of that.
Although there was great displeasure with LD50 test results by the scientific community, no significant changes were made to the tests until the early 1990s. Refinements to LD50 tests, which used fewer animals, were suggested as early as the 1940s. More significant suggestions for change came in the 1950s and 70s. However, little was done, as the scientific community was not significantly challenged to make necessary changes to the test.
While the animal welfare community first criticized the LD50 in the 1960s, few coordinated activities against it were undertaken until the 1980s. In 1980, an activist named Henry Spira coordinated a coalition of more than 400 animal protection groups to call for an end to product testing on animals. The campaign, which first focused on Revlon, created a firestorm of public outcry. It was shortly after this period of action against product tests that the scientific community started to seriously look at methods of improving, and possibly eliminating, the LD50.
Probably the most exciting breakthrough in the development of alternatives to the LD50 test occurred just last month when the results of the Multi-Center Evaluation of In Vitro Cytotocity (MEIC) project were released, and validated alternatives to the LD50 were presented to government regulators and scientists. The alternatives identified by this major project, paid for primarily through government grants and animal welfare organization contributions, hold the possibility that the LD50 may soon become a memory.
The Draize Tests
The Draize tests consist of placing a substance into the eyes or onto the skin of animals (usually a rabbit or rodent). In the eye test, the animals eyes are examined at varying intervals for signs of opacity, hemorrhage, ulceration, redness, swelling, and discharge for up to 7 days. The skin irritancy test consists of placing a product on the shaved or abraded skin of an animal and examining the area for signs of allergic reaction for up to 3 days. Tests may result in anything from minor irritation to severe burning and ulceration.
In the early 1940s the U.S. Food and Drug Administration (FDA) commissioned a scientist named John Draize and a number of his colleagues to develop tests to determine dermal (skin) and ocular (eye) irritancy of products. The FDA liked the tests Draize developed because, as in the case of the LD50, numerical scores could be given to products tested. As a result, the Draize tests were accepted as the standard testing method for irritancy under the authority provided by the U.S. Food, Drug, and Cosmetic Act of 1938.
Just as the LD50 test had been criticized for its crude methodology and inaccurate results, the Draize tests suffered the same fate.
From the 1940s until today the Draize tests have been repeatedly criticized by the scientific community. Refinements to the tests have been promoted for decades and alternatives to the test have been suggested for the last 15 years. One of the most comprehensive critiques of the Draize eye irritancy test came from scientists at Proctor & Gamble in 1979. The scientists criticized government regulators for being unresponsive to the great displeasure with the Draize that was held by the scientific community.
Despite all the criticism, very little occurred until the animal advocacy community started pressing for change. As was the case with the LD50, even though a large body of scientists thought the Draize tests were inadequate, those at corporations and in government who determined what tests should be used to safeguard against irritancy maintained the status quo until they were pressured into making change.
The campaign that aimed to end product testing on animals (mentioned earlier in this article) was kicked off with a full-page ad in the New York Times depicting a rabbit who was subjected to the Draize eye irritancy test. The rabbit, half lying on her side and looking miserable, had band-aids covering her eyes. The headline that accompanied the picture read, "How many rabbits does Revlon blind for Beauty's sake?" As stated earlier, this campaign made companies (and eventually regulators) get the massage that the time for alternatives had come.
In the subsequent 17 years since the launch of the campaign, which marked the beginning of the end for the Draize test, dozens of companies and hundreds of scientists have been working on alternatives. Many feel that current test systems adequately address irritancy in a more accurate fashion than the Draize. Others, however, feel that more needs to be done before validated alternatives to the Draize tests become a reality. Either way, we are not far away from the day when these cruel tests get relegated to the dustbin of history.
The story of the Draize and LD50 tests is important for animal activists to know and understand. Even though there were voices in the scientific community that complained about the inaccuracy of the tests for decades, it wasn't until those concerned with animal welfare/rights garnered public support to end the tests that alternatives were given the consideration they deserved. Today, we are on the threshold of having viable alternatives for laboratory procedures that kill millions of animals each year. It is up to us to keep the pressure on, and to get government regulators and the public to support the alternatives, which in reality is support for not only humane but better science.
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