United States Office of Pesticides and Toxic Substances Environmental Protection Office of Pestiade Programs (TS-766C) Agency Washington. DC 2O460 Pesticide Fact Sheet Name of Chemical: Ethalfluralin Reason for Issuance: Date Issued: June 30, 1935 Fact Sheet Number: 58 1) Description of Chemical Generic Name: N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4- (trifluoromethyl) benzenamine Common Same; ethalfluralin Chemical Abstracts Service (CAS) number: Year of initial registration! 1983 Pesticide type: herbicide D»S. producer! Elanco Products Co., Division of Eli Lilly £ Co. 2) Use Patterns and Formulations Emulsifiable concentrate: pre-plant incorporated (PPI) to dry peas, dry beans, soybeans surface applied, cucurbits direct seeded: cantaloupe, cucumber, pumpkin, watermelon 3) Summary of Science Findings Chemical Characteristics (From Elanco General Summary 161/ZGSUm1/AlVl) Ethafluralin is a yellow crystalline solid with a faint amine odor. It has a molecular weight of 333.3, a specific gravity of 1.32/ml, a melting range of 57 to 59»C, an n-octanol-to-water partition coefficient of 5-11, a vapor pressure of 8.2 x 10~5 mnfig at 25°C, and is susceptible to decomposition by ultraviolet light. Ethalfluralin is readily soluble in organic solvents; its solubility in water is 0.3 ppm at 25*C. Toxicological characterisiticsi Ethalfluralin is considered a skin sensitizer. E.G. formulation is irritating to the eyes and skin. E.G. formulation is toxic to fish. Toxicology studies on ethalfluralin are as follows: Oral U>5o, rat: greater than 10g/kg Oral LD5Q, mouse: " " 10g/kg Oral LD5Q, dog: greater than 200 mg/kg Oral U>50f cat: " " 200 mg/kg ------- —2— Acute dermal LE) 50 ., rabbit: greater than 2 gm/kg Primary eye irritation, rabbit: conjunctivitis, no corneal irritation Acute inhalation LC , rat: greater than 0.028 mg/L/hour Toxicology studies on E.C. formulation are as foll is: Oral LD 50 , rat: greater than 2mL/kg A ute dermal LD 50 , rabbit: greater than 2mL/kg Primary dermal irritation, rabbit: alight to moderate irritation Primary eye irritation, rabbit: alight iritis & conjunctivitis; corneal dulling reversible in 21 days Acute inhalation LC , rat: greater than 74.4 uL/L/hour Ethalfiuralin is oncogenic in the rat: m*mm ry gland fibroadenQnas (benign) in females at mid (250) and high (750) ppn dose levels. Using a on.—hit model, the worst—case dietary oncogenic risk is calculated to be 3.77 incidences in one million. Ethalfiuralin is considered a teratQgen in the rabbit: teratogenic No—observed—effect level (NCEL) is 75mg/kg Environmental Characteristics Ethaifluralin binds readily to soil particles and is, thus, not prone to leaching. It is volatile and readily photodegraded. Ethaifluralin concentrations in water would be expected to decline rapidly with a half— life of 1—2 days. Ethalfiuralin residues may transport to aquatic environments via soil erosion. Label warnings include: Do not apply directly to any body of water ox wetlands. Thinoff or erosion fra rt treated areas may be hazardous to fish in neighboring areas. Ecological characteristics: Avian acute oral LD ): Bobihite quail > 2000 mg/kg Avian dietary LC 50 : Boh hite quail > 5000 p mi Avian dietary LC 50 : Mallard duck > 5000 p Fish acute LC 50 : Bluegills: 0.032 pj i (highly toxic) Rainbc trout: 0.037 ppn (highly toxic) Aquatic invertebrate acute LC 50 : Daphnia: 0.365 p n (highly toxic) mallard and bobihite one—generation reproduction: supplementary dietary levels up to 1000 p did not affect reproduction. Tolerance assessment: Tolerance levels of 0.05 p established for parent c pound ethalfluralin in ca modities: dry beans, dry peas, soybeans and cucurbit vegetable group. Real residues of ethalfiuralin detectable in forage items, thus label restriction: Do not graze or forage crop grown in treated soil or cut for hay or silage. ------- “3— Snmmary of Regulatory Position and Rationale Ethaifluralin is regulated as an oncogen and teratqgen. Benefits associated with registered crop uses are considered to outweigh on ogenic risks. There are adequate margins of safety for teratogenic effects. Analysis of benefits and risks is provided in an Agency position document accanpanying the tolerance regulation publiahed December 21, 1983, in the PR for this pesticide. Summary of major data gaps chronic non-rodent feeding (dog) Teratology: second species ------- |