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Alternatives to Testing

While the federal validation of non-animal alternative test methods continues to be a slow and frustrating process, new laws and public concerns about safety, have pushed the need for better and cheaper alternative methods. In February 2008, three federal agencies, the National Human Genome Research Institute, the National Toxicology Program, and the Environmental Protection Agency, announced the establishment of a five-year plan to investigate new technologies that would allow for the rapid testing of large numbers of chemicals while also providing results more applicable to humans. The agencies predict that success of these high throughput mechanisms would result in a “reduction or replacement of animals in regulatory testing.” Never before has science, public policy, and consumer demand all been pushing toward the same goal of more effective testing methods without the use of animals.
Accepted Alternatives
In the U.S., the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) validates alternative methods, and recommends them for use to the scientific and federal regulators. They cooperate with other international bodies to evaluate the accuracy and applicability of new alternative methods. The following are some of the validated alternatives approved by ICCVAM. Click here to view a complete list of accepted alternatives in use worldwide.

Using rodent cells to estimate starting doses for in vivo acute oral toxicity tests, this 3T3 basal cytotoxicity test is a reduction method that minimizes the number of animals used in each procedure.

This NHK basal cytotoxicity method uses human cells to estimate starting doses for in vivo acute oral toxicity tests, reducing the number of animals used for each test.

An in vitro test for detecting eye irritants, the BCOP test method uses tissues obtained from slaughterhouses to replace the use of live animals. Federal agencies have accepted ICCVAM’s recommendation to use this test for identification of products that may cause severe or  permanent eye damage. However, live animals must still be used to confirm negative results.

The ICE test method uses tissue obtained from slaughterhouses, which would otherwise be discarded, to detect eye irritants. Federal agencies have accepted ICCVAM’s recommendation to use this test for identification of products that may cause severe or permanent eye damage. Live animals, however, must still be used to confirm negative results.

An in vitro test to determine skin corrosion, Corrositex® uses a biomembrane and chemical detection system that changes color when in contact with corrosive substances. In some cases, this could replace the use of rabbits in corrosivity research; however, ICCVAM concluded that in certain cases Corrositex® should be used in conjunction with animal tests.

A model of reconstructed human epithelium, developed to test skin corrosion. This method was first validated by the European Coalition on the Validation of Alternative Methods (ECVAM) as a complete replacement for animal tests. In contrast, ICCVAM has validated EPISKINTM for reduction purposes, suggesting that some substances may need to be tested on animals after using this method.

Used in the study of skin corrosion and toxicology, EpiDermTM is a layered model of human-derived epidermal keratinocytes. This method was first approved by ECVAM for use as a stand-alone assay. However, ICCVAM recommended that EpiDermTM be used only as part of a tiered assessment strategy, which may or may not involve animals.

Replacing the use of rabbits in skin corrosivity tests, the Rat Skin TER Assay utilizes rat skin samples instead. Despite the fact that ECVAM recommended the Rat Skin TER Assay for use in all corrosivity tests, ICCVAM deemed this method unreliable in testing certain classes of  chemicals, and suggested that traditional animal studies still be used.

The Murine LLNA is used as an alternative to guinea pig tests that screen for allergic reactions on the skin. Unfortunately, the Murine LLNA uses mice as a substitute to test substances topically.

Used to estimate acute oral toxicity, the UDP is an in vivo test that reduces the number of rodents used.

This test has been used for years prior to the passage of ICCVAM. Uses specific strains of common bacteria to detect genetic changes caused by test substances.

These alternatives have already been approved by the European Coalition on the Validation of Alternative Methods (ECVAM) and are awaiting action by ICCVAM. Five in vitro alternatives to the rabbit pyrogen test use cytokine released from human blood cells. These methods have been reviewed by ICCVAM and are now awaiting final approval by federal agencies. ICCVAM recommends these alternatives on a case-by-case basis for certain types of drugs, reducing the use of animals in pyrogenicity testing.

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