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Animal Testing and Alternatives
How many animals are involved?
Each year, an estimated 27 million animals in the United States are
used in research, testing, and education. About half (14 million
estimated) are used for testing, including drugs. Why "estimated"? Data
are incomplete on numbers of animals used in each of the three areas.
Further, the Animal Welfare Act requires facilities to report the usage of
only primates, dogs, cats, guinea pigs, rabbits, and certain other
species. Since rats, mice, and birds, which comprise nearly 90% of all
laboratory animals, are not included in the annual figures, one must
extrapolate to determine overall usage in testing.
What are some of the most common tests that use animals?
- Draize -- The test substance is placed in the eyes of conscious
albino rabbits, usually without anesthesia. The resulting damage to the
eyes is observed. The intent of the test is to predict irritation in
humans due to an accidental exposure. Cost: Up to $1,000 per test. Time:
Up to 21 days.
- Skin irritancy -- The test substance is applied to the shaved areas
of animals' skins to determine sensitivity. Cost: Varies. Time: Up to 30
- Acute toxicity -- The Lethal Dose 50 (LD50), which "determines the
amount of a substance that kills 50% of a group of test animals," falls
into this category and involves animals inhaling or being fed the test
substances. Acute toxicity tests always end in the test animals' deaths.
Do Federal Regulations require animal tests?
The Food and Drug Administration (FDA) strongly urges cosmetic and
household product manufacturers to conduct tests that substantiate the
safety of their products, and actually encourages the use of alternatives.
However, "if a product is marketed without tests, its producer can be held
liable for mislabeling if the product turns out to be hazardous. Even this
liability can be removed if the product has the label 'Warning -- the
safety of this product has not been determined.'" The FDA has recently
taken two positive steps by not mandating the use of the LD50 test and by
designing procedures that minimize the number of animals used. Similarly,
the Consumer Product Safety Commission (CPSC), which has jurisdiction over
household products, issued the following statement: "Neither the [Federal
Hazardous Substances Act] nor the commission's regulations require any
firm to perform animal tests."
Why does testing on animals persist?
There is no simple answer. Major reasons include:
- Lack of a validation process -- No nationally agreed-upon process
exists to evaluate the reliability and relevance of a test system.
(Update: As of March 21, 2000, the Interagency Coordinating
Committee on the Validation of Alternative Methods, an organization
established in 1997 to foster alternative and improved test methods, has
now validated two such tests. See www.niehs.nih.gov/oc/news/corros2.htm.)
- Absence of a regulatory approval method -- No uniform standards
exist for regulatory approval of in vitro (in test tube or glass)
- Public safety concerns -- The public has been led to believe that
testing using animals assures the safety of a product.
- Liability issues -- Manufacturers and suppliers claim they must test
on animals to protect themselves in the event of lawsuits. This simply
is not accurate since "product liability law in most jurisdictions
follows the 'strict liability' standard." No matter how much testing is
done, the manufacturer or supplier is still "liable for injuries caused"
by its products.
- Opposition from the medical community -- Many medical professionals
fear a "slippery slope" effect. That is, if animal tests are replaced
with in vitro tests for cosmetic and household products, doctors
are concerned that soon this will lead to limitations in the use of
animals for biomedical research.
- Difficulty of changing the status quo -- Results from animal tests
have been used for more than 50 years and, to a great extent, are
- Funding discrepancies -- Funding for tests involving animals is at
enormously higher levels than funding for alternatives. For every
$30,000 in sales, private organizations spend only 25 cents (on average)
for alternative tests.
Today, many product manufacturers and governmental agencies are
developing and using more humane testing methods. These institutions are
reducing, and in some instances eliminating, the use of animals in various
tests. Among those manufacturers who still test their products on live
animals, there are reports of substantial reductions in both the number of
tests being performed and in the number of animals being used in those
tests. Increasingly, manufacturers and government agencies are realizing
that eliminating testing on animals usually saves both time and money.
What is meant by an "alternative test"?
An alternative test falls into one of three categories:
replacement using non-animal methods; reduction in the
number of animals used; or refinement of the experimental design
and methods to reduce pain and distress to animals. It is important to
understand that a test can still use animals and be considered an
What are some examples of alternative tests?
The following replacement alternatives use no animals:
- Eytex (In Vitro International, Irvine, CA) -- Eytex tests for
irritancy in the human eye using "a protein derived from the jack bean
... [which] becomes opaque when test materials are added." Time: 8
hours. Cost: Less than $100. Correlation with Draize test: Up to 100%.
- Corrositex (In Vitro International) -- Corrositex determines the
corrosivity of chemical products by the length of time it takes for a
color change within the test material. Corrositex has been approved for
use by the Department of Transportation and the Occupational Safety and
Health Administration. Time: Up to 4 hours. Cost: Approximately $175.
Correlation with animal tests: Up to 93%.
- Skin2 (Advanced Tissue Sciences, La Jolla, CA) --
Skin2 is "derived from neonatal foreskin tissue obtained
during routine infant circumcision" and can be used in place of the skin
irritancy test. Time: 8-24 hours. Cost: approximately $500. Correlation
with animal tests: Up to 94%.
- Agarose diffusion (In Vitro International) -- In agarose diffusion,
which uses a derivative of a sea plant, irritants cause cells to die.
Agarose diffusion determines the toxicity of detergent and cosmetics.
Time: less than 24 hours. Cost: $50-100. Correlation with Draize test:
Up to 100%.
With the public's outspoken and growing concern for animals, the
limited reliability of animal test results, and the time, cost, and labor
of animal tests, research into alternatives makes both scientific and
humane sense. Continuous public pressure must be maintained to ensure
increasing use of alternatives, especially in vitro tests, in
product testing. The speed at which industry, government, and universities
work toward the greater use and acceptance of alternatives is affected by
public pressure. You can help make a difference by:
- using your purchasing power to buy products whose ingredients and/or
final product were not tested on animals;
- calling company toll-free numbers to express your interest in
minimizing the numbers of animals used;
- supporting legislators who introduce legislation or regulations that
would encourage the use and acceptance of in vitro tests.