Major Medical News: U.S. Government Announces Plan to Stop Using Animals in Laboratory Toxicity Testing!

http://www.aavs.org/site/c.bkLTKfOSLhK6E/b.6457299/k.82D0/Types_of_Animal_Testin...

AAVS...

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TYPES OF ANIMAL TESTING...

Irritancy

John H. Draize, Ph.D., a scientist at the United States Food and Drug Administration (FDA), developed the Draize eye test in 1944 to assess eye irritation caused by various chemicals. In the test, a substance is placed in one eye, with the other eye serving as a control. The rabbits are restrained, preventing them from responding naturally to the irritation, and their eyes are evaluated after one hour and then at 24-hour intervals for up to 14 days. Some continue to be evaluated up to three weeks later. The level of irritation to the eyes is scored numerically by observation of the three major tissues of the eye (cornea, conjunctiva, and iris). Rabbits suffer from redness, bleeding, ulcers, and even blindness, and are likely killed upon completion of the experiment.

The Draize eye test has been criticized for several reasons. The structure of the cornea of the eye of a rabbit differs significantly from that of a human. Rabbits also produce a smaller volume of tears than humans, allowing chemicals and other irritants placed in rabbit eyes to linger longer and cause more irritation. Not only does this make the Draize eye test unreliable, but it also adds to the immense suffering caused by this test. Finally, evaluated damage caused to the eye is highly subjective leading to a great deal of variation in results. While no non-animal alternative has yet been approved as a replacement for the Draize eye test, two alternatives have been created to allow for partial replacement of animal tests in a tiered testing scheme.

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PHOTO: L'Oreal Bunny Testing

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CONTINUED...

PART TWO...

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ANOTHER CHALLENGE is the unacceptability of false negative results in environmental toxicology. Screening in the pharmaceutical industry can tolerate a small percentage of false negatives-instances in which a compound is deemed safe when it is actually toxic-so long as safe compounds also are identified for further development. But such false negatives are unacceptable for environmental toxicology. If false negatives create an illusion of safety that diverts toxic chemicals from further testing, those misleading results could become "problematic," Kavlock says.

There are also practical issues involved with adapting pharmaceutical methods for environmental toxicology. High-throughput screening protocols in the pharmaceutical industry have been optimized in dimethyl sulfoxide (DMSO). Unfortunately, many chemicals of environmental interest aren't soluble in DMSO. What's more, DMSO is unattractive as a solvent for toxicity testing because it is itself toxic at high enough concentrations.

Although the pharmaceutical industry uses its high-throughput methods to screen for compounds that have some sort of biomedically interesting activity, it's better to think of environmental toxiciologists using such methods to "profile" the biological activity of compounds, says Christopher Austin, director of the National Institutes of Health Chemical Genomics Center (NCGC) in Bethesda, Md. NCGC is teaming up with EPA and NTP to adapt its high-throughput methods to screen chemical libraries for environmental applications. "Profiling means you characterize and document the biological activity or lack thereof for every compound in your collection," he explains.

Such profiles are more useful if they include measurements at multiple concentrations. Pharmaceutical screening is typically performed at a single concentration, but environmental toxicologists want a dose-response curve. NCGC has developed a method in which they use 15 concentrations over a broad range, resulting in a dose-response curve for every compound (Proc. Natl. Acad. Sci. USA 2006, 103, 11473).

EPA is evaluating this and other new approaches to environmental toxicology through its ToxCast program. The agency has awarded nine contracts to test a broad range of assays. Organizers are sending an initial set of more than 300 compounds to each of the companies involved. The compounds selected for this first round are ones for which a rich supply of traditional toxicology data already exists.

The companies involved in ToxCast are using cell-based and biochemical assays to generate toxicity signatures for compounds of interest and see whether they correlate with known toxicity information. One of the companies is Burlingame, Calif.-based BioSeek. Each of BioSeek's assays contains different cell types that represent different tissues and disease states. They measure the levels of a variety of biological molecules that are related to known effects. "We're looking for the ability to detect and distinguish different toxicity mechanisms," says Ellen Berg, the company's chief scientific officer.

EPA plans to use the assay results from BioSeek and the other companies that received contracts to construct predictive signatures of toxicity. In the next phase of ToxCast, the program's managers will validate the approach using additional chemicals. Eventually, the goal is to use the signatures to predict toxicity in newly introduced commercial chemicals.

AUSTIN ESTIMATES that about half of the compounds in the first set to be tested are nondruglike. He confesses that in the initial stages of the program, his center avoided analyzing some of the more challenging compounds.

"Ill-behaved" compounds could produce data artifacts that would obscure whether such an approach works at all, Austin says. "You want to use relatively well-behaved compounds; then the use of nasty compounds becomes an experiment in itself."

The NRC report calls for increased emphasis on assays that incorporate human cells rather than whole animals. Berg calls the use of human cells a "first big step." She hopes that assays using human cells will at least correlate with existing animal data.

Austin doubts that cell-based assays will eliminate animal testing entirely. "My guess is that we will end up with panels of assays that will be in vivo proxies for each of the major types of toxicities." Most types of toxicity are studied in a distinct animal model. If cell-based assays can predict how a compound is likely to act, then toxicity testing can be limited to certain animal models.

Even if in vitro tests reduce rather than eliminate animal tests, they will be a success. Further animal testing might be unnecessary for those compounds that cause obvious toxicity in many cell lines.

"We hope we will provide EPA a science-based system that's capable of prioritizing chemicals for animal testing," Kavlock says. "If we're exceptionally good, we'll be able to pinpoint what animal tests should be done."

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http://pubs.acs.org/cen/science/85/8532sci1.html

C&EN...

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August 6, 2007
Volume 85, Number 32
pp: 34-35

Toxicity Testing Without Animals

High-throughput methods could reduce need for animals when assessing toxicity of chemicals in environment

Celia Henry Arnaud

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PART ONE...

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ANIMAL TESTING has long been considered the gold standard for environmental toxicology, the determination of the toxicity of chemicals found in the environment. But animal testing takes a long time and entails the deaths of animals to acquire data. Even more, the results can't always be extrapolated to humans. Environmental toxicologists are turning to high-throughput methods developed in the pharmaceutical industry as alternatives to the traditional methods and as ways to prioritize chemicals for more in-depth testing.
Shutterstock.com
reduction High-throughput assays may decrease the number of rodent toxicity tests that are needed.

The rat cancer bioassays used by the National Toxicology Program (NTP) take two years. NTP is an interagency program charged with evaluating the toxicity of commercial chemicals and is housed within the National Institute of Environmental Health Sciences in Research Triangle Park, N.C. Because such tests are so time-consuming, only a handful of commercial chemicals have gone through the entire battery of NTP tests.

The pharmaceutical industry uses high-throughput screening methods to identify compounds that can be starting points for drugs. But for drug toxicity testing, the industry still turns to the old standby of rodent tests. Several government organizations are working to adapt high-throughput methods for toxicity testing, with the goal of developing in vitro assays that can predict toxicity.

A recent report from the National Research Council (NRC) recommends the development of cell-based screening methods as a replacement for animal testing (C&EN, June 18, page 13). Although toxicologists share the vision that cell-based assays will eliminate the need for animal testing, they suspect it will take many years to become a reality. In the shorter term, high-throughput methods could help prioritize chemicals for current time-consuming methods of toxicity testing, says Robert Kavlock, director of the Environmental Protection Agency's National Center for Computational Toxicology in Research Triangle Park.

Environmental toxicologists face a formidable challenge. They must put together batteries of tests, and they need to understand how the patterns of results from those tests correlate with toxicity, first in animals (because that's what the bulk of current data relates to) and then in humans. From the patterns of data and responses, toxicologists hope to categorize chemicals in classes and make assumptions about the safety of particular chemicals. "It's an enormously difficult undertaking," says John Bucher, associate director of NTP.

The foremost challenge derives from the broad range of compounds found in the environment. Pharmaceutical methods are optimized for compounds with "druglike" properties, such as low molecular weight, solubility, and bioavailability. Although some environmental compounds share these druglike properties, many do not.

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CONTINUED...

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http://www.thenazareneway.com/vegetarian/animal_testing_toxic__tragic.htm

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The Nazarene Way of Essenic Studies
Animal Testing: Toxic & Tragic

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Every year, millions of animals suffer and die in painful tests to determine the "safety" of cosmetics and household products. Substances ranging from eye shadow and soap to furniture polish and oven cleaner are tested on rabbits, rats, guinea pigs, dogs, and other animals, despite the fact that test results do not help prevent or treat human illness or injury.

Eye Irritancy Tests

In these tests, a liquid, flake, granule, or powdered substance is dropped into the eyes of a group of albino rabbits. The animals are often immobilized in stocks from which only their heads protrude. They usually receive no anesthesia during the tests.
After placing the substance in the rabbits' eyes, laboratory technicians record the damage to the eye tissue at specific intervals over an average period of 72 hours, with tests sometimes lasting 7 to 18 days. Reactions to the substances include swollen eyelids, inflamed irises, ulceration, bleeding, massive deterioration, and blindness. During the tests, the rabbits' eyelids are held open with clips. Many animals break their necks as they struggle to escape.
The results of eye irritancy tests are questionable, as they vary from laboratory to laboratory-and even from rabbit to rabbit.

Acute Toxicity Tests

Acute toxicity tests, commonly called lethal dose or poisoning tests, determine the amount of a substance that will kill a percentage, even up to 100 percent, of a group of test animals.
In these tests, a substance is forced by tube into the animals' stomachs or through holes cut into their throats. It may also be injected under the skin, into a vein, or into the lining of the abdomen; mixed into lab chow; inhaled through a gas mask; or introduced into the eyes, rectum, or vagina. Experimenters observe the animals' reactions, which can include convulsions, labored breathing, diarrhea, constipation, emaciation, skin eruptions, abnormal posture, and bleeding from the eyes, nose, or mouth.(1)

The widely used lethal dose 50 (LD50) test was developed in 1927. The LD50 testing period continues until at least 50 percent of the animals die, usually in two to four weeks.

Like eye irritancy tests, lethal dose tests are unreliable at best. Says Microbiological Associates' Rodger D. Curren, researchers looking for non-animal alternatives must prove that these in vitro models perform "at least as well as animal tests. But as we conduct these validation exercises, it's become more apparent that the animal tests themselves are highly variable."(2) The European Center for the Validation of Alternative Methods' Dr. Michael Ball puts it more strongly: "The scientific basis" for animal safety tests is "weak."(3)

Lethal But Legal

No law requires animal testing for cosmetics and household products. The Food and Drug Administration (FDA) requires only that each ingredient in a cosmetics product be "adequately substantiated for safety" prior to marketing or that the product carry a warning label indicating that its safety has not been determined. The FDA does not have the authority to require any particular product test. Likewise, household products, which are regulated by the Consumer Product Safety Commission (CPSC) the agency that administers the Federal Hazardous Substances Act (FHSA) do not have to be tested on animals. A summary of the CPSC's animal-testing policy, printed in the Federal Register, states, "[I]t is important to keep in mind that neither the FHSA nor the Commission's regulations require any firm to perform animal tests. The statute and its implementing regulations only require that a product be labeled to reflect the hazards associated with that product."(4)

Testing methods, therefore, are determined by manufacturers. The very unreliability of animal tests may make them appealing to some companies, since these tests allow manufacturers to put virtually any product on the market. Companies can also use the fact that their products were tested to help defend themselves against consumer lawsuits. Others believe that testing on animals helps them compete in the marketplace: Consumers demand products with exciting new ingredients, such as alpha-hydroxy acids, and animal tests are often considered the easiest and cheapest way to "prove" that new ingredients are "safe."

Alternatives to Animal Tests

Such arguments carry little weight with the more than 500 manufacturers of cosmetics and household products that have shunned animal tests. These companies take advantage of the many alternatives available today, including cell cultures, tissue cultures, corneas from eye banks, and sophisticated computer and mathematical models. Companies can also formulate products using ingredients already determined to be safe by the FDA. Most cruelty-free companies use a combination of methods to ensure safety, such as maintaining extensive databases of ingredient and formula information and employing in vitro tests and human clinical studies.

Tom's of Maine went one step further. For seven years, the cruelty-free company petitioned the American Dental Association (ADA) to grant its seal of approval to Tom's of Maine toothpastes. Other toothpaste companies unquestioningly conducted lethal tests on rats in order to be eligible for the ADA seal (researchers brush rats' teeth for more than a month, then kill the animals and examine their teeth under a microscope). But Tom's of Maine worked with researchers to develop fluoride tests that could safely be conducted on human volunteers. The ADA finally accepted the results of these tests and granted its seal to several of the company's toothpastes in 1995.(5) The groundbreaking effort by Tom's of Maine to find a humane alternative to accepted-but cruel-practices sets a precedent that other manufacturers can follow in the future.

Compassion in Action

Caring consumers also play a vital role in eliminating cruel test methods. Spurred by public outrage, the European Union (EU) proposed banning cosmetics tests on animals by 1998; unfortunately, the EU has indefinitely delayed this ban because of complaints by animal-testing companies. But other organizations in Europe have stepped in. For example, after conducting surveys showing that four out of five of its customers are against testing cosmetics and household products on animals, the Co-op, Britain's largest retailer, launched its own campaign urging companies to end such tests.

In the United States, a survey by the American Medical Association found that 75 percent of Americans are against using animals to test cosmetics.(6) Hundreds of companies have responded by switching to animal-friendly test methods. To help consumers identify products that are truly cruelty-free, a coalition of national animal protection groups has developed the Corporate Standard of Compassion for Animals, which clarifies the non-animal- testing terminology and procedures used by manufacturers and makes available a cruelty-free logo for companies that are in compliance with the standard. Shoppers can support this initiative by purchasing products that comply with the corporate standard and boycotting those that don't and by asking local stores to carry cruelty-free items.

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References

Rowan, A.N. Of Mice, Models, & Men: A Critical Evaluation of Animal Research (Albany: State University of New York Press, 1984).
Branna, Tom, "Animal Testing Alternatives: Moving Closer to Validation?" happi, February 1995.
Ibid.
Federal Register, Vol. 49, No. 105.
Ahrens, Frank, "Why Is This Rat Smiling?" The Washington Post, August 17, 1995.
Branna.

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http://www.gan.ca/lifestyle/animal+testing/index.en.html

Global Action Network...

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Animal Testing
What's Wrong With Testing on Animals?

Every year, millions of animals are poisoned, blinded, and killed in crude tests to evaluate the toxicity of consumer products and their ingredients. Rats, mice, guinea pigs, rabbits, and other animals are forced to swallow or inhale huge quantities of a test substance or endure the pain of a chemical eating away at their sensitive eyes and skin .

But the suffering and death of these animals is entirely unnecessary in the making of products like your shampoo, eye shadow, and toilet cleaner. No law requires animal testing of cosmetics or personal care and household cleaning products, so manufacturers of these products have no excuse for inflicting suffering on animals. Companies that test these types of products on animals should be boycotted until they change to a non-animal-testing policy.

You may think companies that test on animals do so for your safety, but these tests usually aren’t reliable in determining a chemical’s effect on humans. Reactions can vary greatly from species to species so it is quite difficult to come to any conclusions about what a substance will do to humans by testing it on a rabbit. In fact, a product that made a test animal go blind could still be sold to you. In addition to being cruel and unreliable, animal tests also tend to be more expensive than alternative methods, making them both unkind and inefficient.

Many of the companies that manufacture cosmetics and household-products have turned their backs on animal testing in favour of the various non-animal test methods available today. These include human cell cultures and tissue studies (in vitro tests) and artificial human “skin” and “eyes” that mimic the body’s natural properties, and a number of computer virtual organs that serve as accurate models of human body parts. One example are EPISKIN™ and EpiDerm™, multi-layered skin models made up of cultures of human skin cells, which have been scientifically validated and accepted around the world as total replacements for rabbit skin corrosion studies.1

The best ways to pressure companies to give up animal testing is to boycott their products. Let the lists of Companies That Do Test on Animals and Companies That Don’t Test on Animals be your guide and start shopping kindly.

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References
1. National Toxicology Program, “Episkin™, EpiDerm™, and Rat Skin Transcutaneous Electrical Resistance (TER), In Vitro Test Methods for Assessing the Dermal Corrosivity Potential of Chemicals,” National Institute of Environmental Health Sciences, Aug. 2001

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We're also getting closer to stopping research on chimps. I wish I felt like l could celebrate, but I want to SEE IT first.

http://www.washingtonpost.com/national/health-science/report-research-on-chimps-...

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Tens of thousands of animals' lives could be saved every single year.

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