Medicine, Health Care Collaborative Effort Aims to Replace…
Published: August 21, 2017.
Released by Institute for In Vitro Sciences
Washington, D.C. — August 21, 2017 — A first-of-its kind collaborative project is underway to find a non-animal test method to replace the rabbit vaginal irritation test for personal lubricants. The U.S. Food and Drug Administration (FDA) gave the project a green light as part of the agency’s program aimed at modernizing the tests used to develop and evaluate medical devices.
The work of the lubricant industry, the Institute for In Vitro Sciences (IIVS), the PETA International Science Consortium Ltd., and the Consumer Healthcare Products Association (CHPA) follows efforts to show that animal testing for lubricants can and should be replaced by non-animal methods, in part because rabbits and humans have very different physiologies.
Regulatory authorities commonly require that personal lubricants, defined by FDA as Class II medical devices, undergo a series of safety tests before they can be marketed and sold. The Rabbit Vaginal Irritation (RVI) test is the most commonly used method to assess the irritation potential of personal lubricants, during which rabbits are vaginally exposed to lubricants for at least five days before being euthanized and dissected for tissue examination.
Human in vitro tissue models are now available that may replace RVI. The project will collect existing data and conduct targeted in vitro testing as necessary to determine if these animal-free methods can be used in place of RVI for personal lubricant products. The results of the study will be submitted to FDA and, following successful evaluation, the in vitro tissue model methods will be usable for personal lubricants. The project will be presented at the 10th World Congress on Alternatives and Animal Use in the Life Sciences in Seattle, Washington, August 20-24, in a poster titled, “Non-animal testing approach to address biocompatibility testing of medical devices required by the United States Food and Drug Administration.”
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