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US EPA granted data waivers for acute dermal toxicity studies for formulated pesticide products
Dec. 6, 2016
The US EPA has issued "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations and Supporting Retrospective Analysis" in November 2016, to expand data waivers for acute dermal studies for formulated pesticide products.
The EPA says that several published studies have investigated comparability between oral and dermal acute hazard classifications to assess whether tests for both routes are needed. Together, these studies suggest that dermal and oral acute studies generally classify chemicals into similar categories, but none suit the needs of the Office of Pesticide Programs (OPP) since they did not evaluate the EPA OPP categorization scheme and primarily evaluated single agents.
OPP and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) have conducted a retrospective analysis of oral and dermal acute lethality studies that fit the regulatory context relevant for OPP. This analysis focuses on formulated pesticide products and considers the EPA pesticide categorization scheme which uses acute study results. The OPP/NICEATM analysis is designed to evaluate the relative consistency of the findings of oral and dermal studies. The agency has used this analysis to support a policy statement to waive all acute lethality dermal studies for formulated pesticide products.
The agency believes the retrospective analysis fully supports the conclusion that waivers may be granted for acute dermal toxicity studies for formulated pesticide products. Applicants should submit formal waiver requests as part of their registration application through existing processes. Waiver requests should contain all relevant information to support the waiver (e.g., acute oral LD50 and dermal irritation study data) and cite this guidance.
Source: U.S. EPA
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