Comparison Assessment for Acute Oral and Dermal Toxicity of Plant Protection Products and Active Ingredients

A. Acute Oral Toxicity…………………………………….…………….…….4 B. Acute Dermal Toxicity…………………………………………….………4 C. Acute Inhalation Toxicity…………………………………………………5 D. Primary Eye Irritation……………………………………………………..8 E. Primary Dermal Irritation……………………...………………………….8F. Dermal Sensitization………………………………………………………..9 G. Granular Pesticides………………………………………………….…….10 1.Granular Pesticide Products……………………………………..……..10 2.Granular Fertilizer Pesticide Products…………………………………11 3.Rodenticide Baits…………………………………………………..….…12 III.Use Dilutions……………………………………………………………………12 IV.Mixtures…………………………………………………………………………13 V. Bridging of Data for Acute Toxicity Waivers/Endpoints……………...….…13 A. Bridging of End-Use Product Data……………………………………….14 B. Bridging of Toxicologically Similar Products……………………………15 VI. References………………………………………………………………………16Criteria for waiving or bridging acute toxicity data appear in:• Memoranda from OPP's Registration Division (US EPA, 1992) and Health Effects Division (U.S. EPA, 1993); these memoranda describe considerations that will generally support a waiver request for each type of mammalian acute toxicity test.• 40 CFR 158.500, 40 CFR 161.340, 40 CFR 158.2050, and 40 CFR 158.2083, which contain footnotes to the acute toxicity testing data requirements that describe when acute toxicity tests are not required for conventional, antimicrobial, biochemical, and microbial pesticides, respectively.• Office of Chemical Safety and Pollution Prevention (OSCPP) guidance (harmonized guideline 870.1000), which contains several Agency recommendations for reducing the number of animals used in acute toxicity testing.One significant recommendation made in this document is the concept of bridging toxicity data from one chemical or product formulation to another instead of conducting additional tests.• Pesticide Registration Notice 2001-02, which discusses acute toxicity data requirements for granular pesticide products, and includes criteria that would support a waiver for acute toxicity testing of granular pesticide products.• Chapter 2 of the OCSPP Pesticide Registration Manual (http://www.epa.gov/opprd001/registrationmanual/chapter2.html), which discusses bridging of toxicologically similar products.The purpose of this document is to consolidate information from these sources and provide a single source for consultation on the use of waiver and bridging criteria for acute toxicity testing.This current document supersedes all existing OPP guidance documents on waiver and bridging criteria for mammalian acute toxicity tests.While every effort has been made to make this guidance document as comprehensive and updated as possible, it is expected that there will also be cases where requests for waivers or bridging will fall outside the scope of this document and that will require separate review and/or consultation with the Agency.Note that as the science advances, new and/or alternative approaches to waiver and/or bridging requests may be developed, and this guidance will be updated to reflect these approaches.