Evaluating the Functional Equivalency of Test Organism Performance in Negative and Solvent Controls During Chronic Sediment Ecotoxicity Studies Based on US Environmental Protection Agency Guidance

Author:

Valenti Theodore1,Kabler Kent1,Dreier David1,Henry Kevin2,Jones Alan3ORCID,McCoole Matt4,Cafarella Mark5,Collins Jennifer6ORCID,Bradley Michael7,Samel Alan8,Basu Manoit9

Affiliation:

1. Syngenta, Greensboro North Carolina USA

2. Tessenderlo Kerley, Phoenix Arizona USA

3. ADAMA, Raleigh North Carolina USA

4. Bayer, Monheim Nordrhein‐Westfalen Germany

5. Three Points Ecotox Consulting, Marion, Massachusetts USA

6. Waterborne Environmental, Leesburg Virginia USA

7. Smithers, Wareham Massachusetts USA

8. FMC, Newark Delaware USA

9. CropLife America, Washington DC USA

Abstract

AbstractThe US Environmental Protection Agency (USEPA) considers sediment toxicity tests as conditional registration requirements for pesticides with soil Kd ≥50 L/kg‐solid, Koc ≥1000 L/kg‐organic carbon, or log Kow ≥3. The hydrophobicity of these compounds often necessitates use of solvents to ensure accurate and homogeneous dosing of spiked‐sediment studies. For sediment tests, a volatile solvent (e.g., acetone) is generally used as a transient carrier. Due to low water solubility, test material is dissolved in a volatile solvent to create stock solutions. A measured aliquot of stock solution is then mixed with sand substrate, after which the solvent is evaporated. This spiking process results in negligible solvent exposure to organisms. In 2016, USEPA released final ecotoxicity test guidelines for subchronic freshwater (850.1735) and marine (850.1740) sediment test. These methods provide an option for conducting experiments with only a solvent control and no negative control. To adopt this testing strategy, functional equivalency between the negative and solvent control must be demonstrated. These test guidelines describe specific factors that should be considered for evaluating functional equivalency, including (a) the concentration of solvent in the test sediment after evaporation, (b) the levels of solvent that are known to affect organism health, (c) the known impurities in the solvent and their potential impact on organism health, and (d) the historical organism performance of solvent versus negative controls. Our analysis considers these factors and overall supports the elimination of the negative control requirement because this change is unlikely to impact the robustness or interpretability of spiked‐sediment toxicity tests. Environ Toxicol Chem 2023;00:1–7. © 2023 CropLife America. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

Publisher

Wiley

Subject

Health, Toxicology and Mutagenesis,Environmental Chemistry

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