New EPA Guidance Focuses on Decreasing the Need for Animal Dermal Toxicity Testing

• November 4, 2020

In late 2019, the U.S. Environmental Protection Agency (EPA) put forth a directive with the goal of substantially reducing the use of animal testing. The Agency recently made additional progress in these efforts by making new draft guidance available with a focus on preventing the need for dermal toxicity testing in animals. In this blog post, we review this guidance information and discuss its significance.

Animal Testing

Animal testing is the utilization of animal (non-human) subjects in research to establish how the manipulation of certain variables affects them. The purposes of animal testing may vary depending on the experimental or research situation. Some of the more common examples have included cosmetics testing, evaluating disease treatments, and researching the toxicological effects of chemical substances. Despite its use, the employing of animal models for chemical testing can be costly, time consuming, and fraught with ethical implications.

About the Guidance

To support and help inform its recent draft guidance development, the EPA conducted an evaluation of oral and dermal LD50 studies in rats, with a focus on 249 chemicals. A principal goal of the analysis was to assess the usefulness of acute dermal toxicity testing of chemicals for pesticide labelling.

Key findings of this evaluation indicated that:

• For 32% of the chemicals, a lower toxicity category encompassed oral study results
• For 67% of the chemicals, a single toxicity category encompassed both oral and dermal study results

The Agency’s findings suggested that its requirements for acute dermal toxicity studies may not be valuable in terms of providing decision support information.

The EPA’s guidance will permit applicants to waive chemical testing on animal skin (in select situations) in efforts to evaluate the potential harmful effects of pesticides. Waiver requests should be included as part of the applicant’s registration process.

The EPA estimates that an annual savings of at least 750 animals is expected to result from this guidance. Agency Administrator Andrew Wheeler recently commented on its significance, noting it “puts EPA on a path of eliminating the need for all mammal testing by 2035”. He further stated that it is “a great example of how we can continue to protect human health and the environment and make science-based decisions about pesticide registrations without needing to conduct unnecessary tests on the skin of animals”.

Accessing More Information

EPA guidance information can be an invaluable resource for a wide range of professionals, including chemical safety professionals of all types. More information regarding the recently released guidance may be found on the EPA website as it becomes available. Additionally, you can visit the ToxPlanet website and blog regularly for information on new developments. Also, be sure to contact us and register for a Free Trial to learn how our robust suite of solutions can help address your chemical hazard information needs.