Non-animal tests

The following is a brief overview of some new test methods that should be used in the HPV program to reduce or eliminate animal use:

Acute toxicity can be studied using cell culture (in vitro) systems, since the actions of toxic chemicals are often focused at the cellular level. For example, a series of four cell culture tests can predict toxicity in humans with nearly 85 percent accuracy (compared to 65 percent in acute toxicity studies using animals). This method should, within several years, be able to replace the horrendously cruel use of animals in acute lethal poisoning testing.

Repeated dose toxicity can be studied using cells cultured from different body tissues to estimate the effects of a chemical on different organ systems. For example, human liver cells in culture could be exposed to repeated, low doses of a chemical in order to study how it is broken down (metabolized) by the body and to identify any toxic by-products (metabolites) that may be produced in the process. Stable human cell cultures have been produced for kidney, nervous, immune, reproductive, and other essential organ systems. A tiered testing strategy that combines several of these tissues in culture with the use of computer and mathematical modelling, has the potential to do away with animal use in repeated-dose toxicity studies.

Reproductive toxicity and aspects of male and female reproductive function can be modeled to some extent in vitro, and several cellular components of reproductive organs can be maintained in cell culture. Although no test method has yet been used or validated for routine use in reproductive toxicity studies, it is possible that a battery of such systems may in the future be able to model a large proportion of the male and female reproductive cycles, thereby reducing or replacing animal use in reproductive toxicity testing.

Developmental toxicity (teratogenicity) can be studied in cell culture using an embryonic stem cell test, which is currently being validated as a screen for birth defects. Preliminary reports indicate that the in vitro embryonic stem cell test can predict toxicity in humans with over 80 percent accuracy. It is hoped that within several years, this method will be able to eliminate animal use in developmental toxicity testing.

Genetic toxicity can be studied entirely without the use of animals. Three methods in particular (the Bacterial Reverse Mutation Test, In Vitro Cell Gene Mutation Test and In Vitro Chromosomal Aberration Test) have been accepted by government regulators worldwide as valid alternatives to using animals. As such, genetic toxicity testing in animals should be discontinued immediately.

More generally, the following computer-based modeling approaches have shown great promise in contributing to the replacement of animals in toxicity testing:

Structure-activity relationship (SAR) analyses use computers to seek to predict adverse biological effects of chemicals based on their molecular structure, weight and electronic charge. SAR data can be used to estimate whether a specific chemical produces a particular biological response, including toxicity, without recourse to animals. Such approaches have shown 85 to 97 percent accuracy in predicting dermal sensitization, teratogenicity and carcinogenicity for related groups of chemicals.

Computer-based mathematical modelling involves the use of computers to model living biological systems, such as the human circulatory and respiratory systems. For example, physiologically based bio-kinetic models (PBBKs) use computers to study the absorption, distribution, metabolism and excretion of a chemical by the body. They can also be used to determine the relationship between the dose of a chemical and a particular metabolic effect. One such model, the ED01, studies tumor production in response to chemical exposure. It can detect an increased tumor activity of 1 percent, and at doses of a chemical much lower than those customarily used in rodent studies.

U.S. Environmental Protection Agency (EPA)

Wasted Money, Wasted Lives

High Production Volume (HPV) Chemical-Testing Program

Questions and Answers

Animal Tests

Scientific Problems

Non-Animal Tests

Animal Welfare Agreement

Chemical Test Plans

Congressional Testimony

What You Can Do

The Endocrine Disruptor Screening Program (EDSP)

EPA Pesticide Program

Developmental Neurotoxicity (DNT) Testing

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World Wildlife Fund and Animal Testing
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