Data Evaluation Report on the Toxicity of Carboxin Sulfoxide to Fathead Minnows (Pimephales Promelas), Early Life Cycle EPA MRID Number 50341504
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Data Evaluation Report on the Toxicity of Carboxin Sulfoxide to Fathead Minnows (Pimephales promelas), Early Life Cycle EPA MRID Number 50341504 Data Requirement: EPA DP Barcode 442513 EPA MRID 50341504; 50341509 analytical EPA Guideline 850.1400 Test Material: Carboxin Sulfoxide Purity (%): 99.6% Common name: Carboxin Sulfoxide Chemical name: IUPAC: Not reported CAS name: Not reported CAS No.: 17757-70-9 Synonyms: Not reported Primary Reviewer: Rebecca L. Bryan Signature: Staff Scientist, CDM/CSS-Dynamac JV Date: 8/28/2018 Secondary Reviewer: Elizabeth Krupka Signature: Senior Scientist, CDM/CSS-Dynamac JV Date: 11/7/2018 Primary Reviewer: D. Ethan Harwood, M.S. Signature: Biologist, EPA, OCSPP, EFED, ERB4 Date: 12/27/18 EPA PC Code 090201 Date Evaluation Completed: 12-27-2018 CITATION: Milligan, A., Keller, K., and Gallagher, S. 2017. Carboxin Sulfoxide: An Early Life-Stage Toxicity Test with the Fathead Minnow, (Pimephales promelas). Unpublished study performed by EAG Laboratories (formerly Wildlife International Ltd.), Easton, Maryland. Laboratory Study No. 443A-151. Study sponsored by MacDermid Agricultural Solutions, Inc., Waterbury, Connecticut. Study initiated February 22, 2017 and completed August 11, 2017. This Data Evaluation Record may have been altered by the Environmental Fate and Effects Division subsequent to signing by CDM/CSS-Dynamac JV personnel. The CDM/CSS-Dynamac Joint Venture role does not include establishing Agency policies. Page 1 of 18 Data Evaluation Report on the Toxicity of Carboxin Sulfoxide to Fathead Minnows (Pimephales promelas), Early Life Cycle EPA MRID Number 50341504 EXECUTIVE SUMMARY: The 33-day chronic toxicity of the carboxin degradate, carboxin sulfoxide (99.6% purity) to the early life-stage of the freshwater fathead minnow (Pimephales promelas) was studied under flow-through conditions. Fertilized eggs/embryos (80/level, <24 hours old) were exposed to carboxin sulfoxide at nominal concentrations of 0 (negative and solvent [dimethylformamide (DMF); 0.1 mL/L] controls), 0.63, 1.3, 2.5, 5.0, and 10 mg ai/L. The mean- measured concentrations <0.01 (<LOQ, controls), 0.64, 1.3, 2.5, 5.1, and 11 mg ai/L, respectively. The test system was maintained at 24.4 to 25.5°C and a pH of 8.0 to 8.3. No significant treatment-related effects were observed, relative to controls, for hatching success, time to hatch, larval survival, post-hatch survival, or growth (length, wet weight, and dry weight) endpoints up to the highest concentration tested (i.e., 11 mg ai/L). The 33-day NOAEC and LOAEC values were 11 and >11 mg ai/L, respectively. This study is scientifically sound and is classified as acceptable. Results Synopsis Test Organism Size/Age: Embryos, <24 hours old Test Type (Flow-through, Static, Static Renewal): Flow-through NOAEC: 11 mg ai/L LOAEC: >11 mg ai/L Endpoint(s) affected: None I. MATERIALS AND METHODS GUIDELINE FOLLOWED: This study was conducted following guidelines outlined in the U.S. EPA Ecological Effects Test Guidelines OPPTS 850.1400. No deviations from OCSPP 850.1400 were observed. COMPLIANCE: Signed and dated GLP, Quality Assurance, and Data Confidentiality claims statements were provided. This study was conducted in accordance with U.S. EPA GLP Standards as published in 40 CFR Parts 160 and 792 with the following exception: periodic analyses of the water for potential contaminants were not performed according to GLP, but were performed using a certified laboratory and standard US EPA analytical methods. A. MATERIALS: 1. Test Material: Carboxin sulfoxide Description: solid Lot No./Batch No.: 2756-75-RRG Purity: 99.6% Stability of compound Page 2 of 18 Data Evaluation Report on the Toxicity of Carboxin Sulfoxide to Fathead Minnows (Pimephales promelas), Early Life Cycle EPA MRID Number 50341504 under test conditions: The mean measured concentrations were 100-110% of nominal (%CV=2.45-3.78%). Storage conditions of test chemicals: Frozen Physicochemical Values Comments properties of Carboxin. Parameter Water solubility at 20°C 195 mg/L USEPA 20151 -7 Vapor pressure at 25°C 1.8 x 10 torr Structure Kow Log Kow=2.17 4.82 (carboxin sulfoxide) 1USEPA 2015. Registration Review – Preliminary Problem Formulation for the Drinking Water and Ecological Risk Assessments of Carboxin and Oxycarboxin. DP Barcode D423826. 2. Test organism: Species: Fathead Minnow (Pimephales promelas) EPA recommends rainbow trout (Oncorhynchus mykiss), bluegill sunfish (Lepomis macrochirus) or fathead minnow (Pimephales promelas) for freshwater, and sheepshead minnow (Cyprinodon variegatus) for estuarine/marine. OECD recommends rainbow trout, fathead minnows, zebra fish, and ricefish but does not exclude the use of other species. Age /embryonic stage at test initiation: Embryos, <24 hours old EPA recommends fish embryo age at test initiation is as soon as possible after the eggs have been fertilized. Method of collection of the fertilized eggs: Not reported Source: Chesapeake Cultures, Inc. (Hayes, Virginia) B. STUDY DESIGN: 1. Experimental Conditions a. Range-finding study: The concentrations for the definitive study were selected in consultation with the study sponsor and were based on a range-finding toxicity test. The 19-day range-finding study indicated there were no effects on hatching success, larval survival, or wet weight up to a concentration of 10 mg ai/L. Therefore, the definitive test was conducted at concentrations up to the maximum guideline recommended concentration (10 mg ai/L). b. Definitive study: Page 3 of 18 Data Evaluation Report on the Toxicity of Carboxin Sulfoxide to Fathead Minnows (Pimephales promelas), Early Life Cycle EPA MRID Number 50341504 Table 1: Experimental Parameters Remarks Parameter Details Criteria Parental acclimation, if any At receipt, the embryos were Period: removed from the spawning EPA recommends embryos be immersed in the test solutions before cleavage of substrates and examined under a the blastodisc commences, or as close as Conditions (same as test or not): dissecting microscope to select possible after this stage. healthy, viable specimens at Feeding (type, source, amount given, approximately the same stage of frequency): development. Embryos used in the test were from 10 individual Health: (any mortality observed) spawns. Number of fertilized eggs/embryos in 80 embryos/treatment level, each treatment at test initiation divided into 20 embryos/chamber, and 4 Each treatment should include a minimum of 60 embryos, divided equally replicate chambers/treatment between at least 2 replicate test chambers. OECD also recommends at least 60 eggs, divided between at least 2 replicates. Concentration of test material nominal: 0 (negative and solvent controls), A minimum of 5 concentrations, spaced 0.63, 1.3, 2.5, 5.0, and 10 mg by a constant factor not exceeding 3.2, ai/L and a control, all replicated, plus solvent measured: control if appropriate should be used. <0.01 (<LOQ, controls), 0.64, - Toxicant concentration should be 1.3, 2.5, 5.1, and 11 mg ai/L measured at least 5 times at regular intervals, and at least once per week for studies longer than one month. - Concentrations of test substance in solution should be within ± 20% of the mean measured values during study. - One concentration should adversely affect a life stage and one concentration should not affect any life stage. OECD also recommends that 5 concentrations be spaced by a constant factor not exceeding 3.2 and concentrations be within ± 20% of the mean measured values. Solvent (type, percentage, if used) HPLC-grade dimethylformamide (DMF), 0.1 mL/L The solvent should not exceed 0.1 ml/L in a flow-through system. Recommended solvents include dimethylformamide, triethylene glycol, methanol, acetone, and ethanol. OECD recommends that the solvent not have an effect on survival nor produce any other adverse effects; concentration should not be greater than 0.1 ml/L. Number of replicates Page 4 of 18 Data Evaluation Report on the Toxicity of Carboxin Sulfoxide to Fathead Minnows (Pimephales promelas), Early Life Cycle EPA MRID Number 50341504 Remarks Parameter Details Criteria At least 2 replicates per test Negative control: 4 concentration and control. Solvent control: 4 Treatments: 4/level A solvent control should be used in conjunction with a solubilizing agent. Test condition Flow splitting accuracy was within ±10%. Delivery of the test solutions to static renewal/flow-through: Flow-through the test chambers was initiated seven days prior to test initiation in order to achieve equilibrium of the test substance. type of dilution system for flow through method: Continuous-flow diluter Flow-through systems are generally recommended, including a system which flow rate: ca. 10 volume additions per day continually dispenses and dilutes a stock solution of the test substance (e.g. renewal rate for static renewal: N/A metering pump, proportional diluter, or saturator system). EPA recommends that flow rate equal at least 5 test chamber volumes per 24 hours, and not vary by more than 10% throughout the test (OECD also recommends 5 test chamber volumes/24 hours). For flow through tests, biomass loading rate should not exceed 0.5 g/L/24 h and 5 g/L solution at any time. For static-renewal, EPA recommends 2 renewal procedures; either transfer eggs and larvae to new, clean vessels or retain organisms in vessels and change at least 2/3 test water. Aeration, if any No aeration was reported. Aeration is not recommended. Duration of the test 33 days: 5-day hatching period and 28-day post-hatch period EPA recommended test duration is 32 days (or 28 days post-hatch) for fathead minnow and sheepshead minnow; 30 days post-hatch for zebra fish and ricefish; 2 weeks after controls are free- feeding (or 60 days post-hatch) for rainbow trout; and 28 to 60 days for other species. OECD recommendations for test duration are species specific and range from 28-60 days. Embryo cups, if used Embryo cups were oscillated vertically via a rocker arm at 2 rpm.