Product Safety

Product Safety

What are Product Safety Tests?

Product Safety Tests are tests conducted in animals to assure the safety of drugs, and personal or household products. These tests include controlled studies in laboratory animals.

Why are products tested for safety?

Consumers have the right to expect that the products they depend upon are safe when used properly. Physicians and veterinarians also need to know how to treat victims of accidental poisoning or exposure to harmful materials.

Who requires toxicity tests?

In the United States, the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Consumer Product Safety Commission (CPSC) assume responsibility for ensuring consumer safety. The FDA requires information about the effects of new chemicals before testing in humans. FDA regulations do not specify the tests that must be done, but they will not allow human testing if animal safety testing is inadequate or incomplete. The Code of Federal Regulations governing a New Drug Application (NDA) specifically mentions reporting acute, subacute, and chronic toxicity test results before a new medicine may be sold. The EPA administers the Toxic Substances Control Act and the Federal Insecticide, Fungicide, and Rodenticide Act. These laws regulate most other chemicals not covered by the FDA. Animal safety tests are conducted to determine if a substance poses an unreasonable risk to human health or to the environment. The CPSC administers the Federal Hazardous Substances Labeling Act. This law details toxicity tests that are required to determine how a material must be labeled, marketed, or handled in the workplace.

How are safety tests conducted?

Exposure to chemicals may have immediate or long-term consequences. Chemicals may cause skin or eye irritation or severe allergic reactions. Carefully controlled studies in laboratory animals, usually rodents, are conducted under conditions that simulate those under which humans may be exposed to the product. If a non-rodent animal is required to confirm a risk of human toxicity, the first animal of choice is the purpose-bred dog. These studies are always conducted in laboratories that are closely regulated by federal and state agencies. Acute Toxicity Tests: Acute Toxicity Tests in a small number of rodents measure the immediate consequences of chemical exposure. This information is needed by regulators, emergency medical personnel, and poison control centers. Skin and Eye Irritancy Tests (Draize): These tests are especially relevant to establishing the safety of products that may come in contact with the eye or skin, or cause skin sensitization. It is important to establish through controlled tests that materials such as medications or cosmetics can be applied safely without fear of adverse effects. It is equally important to develop appropriate label warnings for certain household products, such as cleaning supplies, polishes, etc. that may be accidentally splashed on the skin or eye. Subchronic and Chronic Toxicity Tests: These tests measure the consequences of long-term exposure to materials used where repeated human exposure is anticipated. These tests involve exposure of animals, usually rodents, via the route (ingestion, skin contact, or inhalation) that simulates exposure for humans. These studies are used by regulatory officials to define a level of repeated exposure that is safe for humans. Tests for genetic toxicity, birth defects, and cancer potential: The potential for causing these types of adverse effects is best determined through the use of carefully controlled studies in whole animals (usually rodents). Non-animal methods are also used where appropriate, but these studies are adjuncts because there are no reliable non-animal replacements for assessing dangers of birth defects or cancer potential.

Are “cruelty-free” products safe?

Most products that are labeled “cruelty-free” have been tested in animals at some time. Distributors often purchase previously tested ingredients, or a standard lotion or cream, and package them as “cruelty-free” because they did not conduct the necessary animal testing themselves. The safety of all of these products is assured by previous animal testing. If a product is sold and its safety is not known, specific labeling is required by federal regulation. The cosmetic product must then carry the following statement: WARNING: The safety of this product has not been determined.

Can we avoid using animals for toxicity testing?

Scientists have made significant efforts to reduce the number of animals used in testing and to replace animals wherever possible. With a cost of around $600,000 to conduct just one chronic toxicity test, industry scientists have been working on cheaper and faster safety tests that do not require animals. Mathematical models, computer simulations, and tissue cultures are used in preliminary testing. These non-whole animal tests have helped to reduce the number of animals needed for safety testing. However, these tests alone cannot reliably predict the effect of a chemical on the combined organ systems of the human body. The health and safety of the American public must always be of primary concern.

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