Final Guidance on Waiving Acute Dermal Toxicity Testing on Animals Released By EPA

In March 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of a final guidance document aimed at providing information on the potential for increased data waiver issuance for acute dermal toxicity studies. This follows and builds upon the Agency's issuance of guidance in 2016 supporting the EPA's goal of decreasing the amount of animal testing being conducted. Here we take a look at the new guidance and review findings of the retrospective analysis underlying it.

Animal Testing

Animal testing involves the use of animal (non-human) subjects in research to establish how they are affected by the control of certain variables. Long utilized for a variety of reasons, some of the more common applications have included the testing of cosmetics and personal care products, assessing the safety of household products, evaluating potential treatments for diseases, and researching the toxicological effects of other chemical substances. Although it has seen widespread use, the employing of animal models for chemical testing can be a costly and time-consuming process. Moreover, its many ethical implications have made animal testing an increasingly controversial practice.

About the New Guidance

The new guidance was supported by an analysis conducted to assess the usefulness of acute dermal toxicity testing for single technical active ingredients in the labelling of pesticides.

249 technical chemicals were evaluated, and findings showed that:

  • Oral and dermal toxicity studies were encompassed by the same toxicity category for 167 (67%) of the chemical substances
  • Oral toxicity studies were in a lower toxicity category than dermal studies for 80 (32%) of the chemicals
  • For 1% of the chemicals (i.e., just 2 of them), it was determined that acute dermal toxicity does not significantly impact requirements for labelling

Collectively, the findings of the evaluation suggest that acute dermal toxicity testing may not contribute significant additional value for decision support.

According to the EPA, the assertion that waivers be granted for acute dermal toxicity testing of pesticidal chemicals is supported by the evaluation findings. Exceptions to this include rodenticides and fumigants, which were not initially assessed. It is suggested that the granting of waivers be considered for these exceptional chemicals on an individual basis.

Accessing More Information

The availability of EPA guidance information can be an invaluable resource for researchers and chemical safety professionals of all types. More information on the recently released final guidance document may be found on the EPA website. Additionally, you can visit the ToxPlanet website and our blog regularly for new and developing information. Also, be sure to contact us and register for a Free Trial to learn how our authoritative solutions can help address your chemical hazard information needs.