Uni ed i itas C doo >f Pi tiocej ana oxic Subranci. Environments. Protec ion C fica of Pe-tia'da Progri m« (TS-7G6C) Agency Washington. DC 20460 &EPA Pesticide Fact Sheet Name of Chemical: Reason for Issuance: REGISTRATION STANDARD Date Issued: DEC 23 1987 Fact Sheet Number: 1. Description of Chemical Common Name: Propanil Chanical Name: 3',4'-dichloropropionanilide Other Names: Surcopur, Supur, Propanex, Propanilo, Supernox, FW-734, Stam, Stampede, DPA, Herbax, Riselect, Erban, Chem Rice, Rogue, S-10165, Strel, Bay 30130 OPP (Shaughnessy) Number: 028201 Chemical Abstracts Service (CAS) Number: 709-98-8 Empirical Formula: CgHgC^NO Molecular Weight: 218.1 Year of Initial Registration: 1962 Pesticide Type: Herbicide U.S. and Foreign Producers: Rohm & Haas Company, Bayer AG, CIFA Laboratory Chemici, C.I.K. Australia Pty., Ltd., Crystal Chemical Inter-America, Cumberland International Corporation, Sintesul, Tifa, Ltd., Visplant-Chimiren S.r.l. 2. Use Patterns and Formulations Application Sites: Rice, spring barley, oats and durum wheat. Percent of Crop Treated With the Pesticide: Rice, 70 to 80 percent-of total U.S. rice crop. Percent of Pesticide Applied to Crop: (1) Rice, approximately 95 percent [9,000,000 to 11,000,000 pounds of active ineredient (ai)] of total domestic usage of propanil, (2) Ubeat, barley oats, approximately 2 to 5 percent (less than 1,000,000 pounds ai) of total domestic usage of propanil. ------- —2- T ypes arid Methods of Application: Applied by conventional aerial or ground equipment as a postaiiergence application. Pest Controlled: Grasses, broadleaf and aquatic weeds. Application Rates: Rates range from 1.13 to 6 lb at/A. Types of Formulations: Manufacturing-Use Products: 85, 90, and 96% ai. End-Use Products: 33, 33.8, 35, and 35.9% ai (3 lb ai/gal) nulsifiable concentrate; 43.48, 43.5, 44.5, 45, and 45.4% ai (4 lb ai/gal) eriulsifiahie concentrate; 35% ai (3 Lb at/gal) soluble concentrate/liquid. Usual Carriers: Water 3. Science Findings Summary Science Stat nent: There are no acceptable data to assess acute toxicity. However, t invalid acute oral studies indicate Toxicity Category III for propanil. The chronic toxicity data were developed from testing three technicals of varying purity. Pending review of the impurity profiles of these technicals, certain studies may need to be repeated. Maternal and developmental toxicity no-observable-effect levels (NOEL) were established at 20 mg/kg/day in separate rat and rabbit teratology studies. In a rat reproduction study, a reproductive and systenic NOEL was established at 300 parts per million (ppm). Results of these three studies do not indicate any toxicological concerns. A suppl nentary mouse oncogenicity study conducted with 85.4% and 98% ai propanil was negative for oncogenic potential at 180 ppm (highest dose tested). E se-related histologic findings were observed in the male liver and the NOEL for this lesion was 30 ppm for the 98% technical and the LEL was 180 ppm for both technicals. Bilateral retinal degeneration in male and f nale mice and thyroiditis in fe nale mice were observed at 180 ppm with the 85.4% ai technical only. NOELs for these effects were not established and the mouse oncogenicity study did not iploy the maximum tolerated dose. Therefore, this study is classified as suppl nentary data and further information, or a new mouse oncogenicity study is necessary. Propanil is not acutely toxic to birds on a dietary basis. The ch nical is slightly to moderately toxic to estuarine and marine organisms and freshwater invertebrates. Propanil is moderately to very highly toxic to freshwater fish. The chemical may pose a risk to same endangered species. The environmental fate of propanil is not adequately understood. Available data indicate that propanil is stable to hydrolysis at pH 7 and 9. ------- -3- Leaching studies indicate that the chenical is mobile to very mobile on sand loam, silt loam, cia’- loam, clay and sand soils. A ground water monitoring study may be required pending the results of mobility and soil field dissipation studies. Chenical Characteristics: Physical State: Solid Color: Medium to dark grey ior: Mildly acrid Melting Point: 89-92 °C Density: 1.25 g/ml at 25 °C Solubility: 0.002 g/ml in water, readily soluble in ketones, alcohols and chlorinated solvents. Vapor Pressure: Less than 0.001 mml-Jg at 50 °C (97% ai), 9.1 x torr at 25 °C (85% ai). Octanol/Water Partition Coefficient: 193 (analytical grade, 99% ai) Stability: Stable at room tanperature. Strong acid or alkali will hydrolyze propanil to 3’ ,4’-dichloroaniline and propionic acid. Toxicological Characteristics: The chronic toxicity data base was developed fran testing three technicals ranging in purity from 85 to 98% ai. Pending review of the thipuricy profile of these technicals certain studies may need to be repeated. o Teratology - Rat: Maternal and developmental toxicity NOEL is 20 mg/kg/day (85.4% ai) o Teratology - Rabbit: Maternal and developmental toxicity NOEL is 20 mg/kg/day (85.4% ai) o Reproduction - Rat: Reproductive and systenic NOEL is 300 ppm. There were no compound-related effects on fertility, gestation, pup viability and lactation, or sex ratios for each generation. o M.itagenicity: Propanil s not mutagenic in gene mutation and chranosomal aberration assays, and in all but one direct DNA damage assay. ------- -4- ?lajor Routes of Exposure Mixers, loaders, and applicators uld receive the most exposure via skin/eye contact and inhalation. Physiological and Biocha nical Behavioral Characteristics: Foliar Absorption: Propanil is absorbed through the leaves. Translocation: The ch nical is translocated to the growing point and back to other leaves. flechanism of Action: Propanil inhibits a number of bioch ical reactions, especially photosynthesis. Environmental Characteristics: Available data are insufficient to fully assess the environmental characteristics of propanil. Leaching studies indicate that the chamical is mobile to very mobile on sandy loam, silt loam, clay loam, clay and sand soils. Propanil is stable to hydrolysis at pH 7 and 9. Pending the results of anaerobic/ aerobic soil metabolism, aquatic metabolism, and field dissipation studies, a ground water monitoring study may be r uired. Ecological Characteristics: o Avian Dietary Toxicity: 1924 ppm (bobwhite quail), greater than 5000 ppm (mallard duck) o Freshwater Fish Acute Toxicity: Less than 3.7 to 5.36 ppm (bluegill sunfish), 2.3 ppm (rainbow trout) o Aquatic Invertebrate Acute Toxicity: 6.7 ppm ( Daphnia magna ) Potential probl ns related to endangered species: The use of propanil on rice may pose a hazard to endangered aquatic species. The Agency is consulting with the U.S. Fish and Wildlife Service to determine whether the fat pocketbook pearly mussel ( Potamilus capax ) may be at jeopardy fr ii the use of propanil on rice. After U.S. Fish and Wildlife Service review, the Agency may impose labeling re uirei ents to protect endangered species. ------- —5.- Tolerance Assessment: Tolerances have been established for residues of propanil in or on the following raw agricultural commodities (RACs): Conunodity Tolerance (ppm ) Barley, grain 0.2 Barley, straw 0.75 Cattle, fat 0.1 (N) 1 ! Cattle, mbyp 2 / 0;1 (N) Cattle, meat 0.1 (N) Eggs 0.05 (N) Coats, fat 0.1 (N) Goats, mbyp 0.1 (N) Coats, meat 0. 1 (N) Hogs, fat 0.1 (N) Hogs, mbyp 0.1 (N) Hogs, meat 0.1 (N) Horses, fat 0.1 (N) Horses, mbyp 0.1 (N) Horses, meat 0. 1 (N) Milk 0.05 (N) Oats, grain 0.2 Oats, straw 0.75 Poultry, fat 0.1 (N) Poultry, mbyp 0.1 (N) Poultry, meat 0.1 (N) Rice 2 Rice, straw 75 (N) Sheep, fat 0.1 (N) Sheep, mbyp 0.1 (N) Sheep, meat 0.1 (N) Wheat, grain 0.2 heat, straw 0.75 A feed additive tolerance of 10 ppn is established for propanil in or on rice bran, rice hulls, rice polishings and other milling fractions resulting from application of the herbicide to the growing RAC rice. 1/ The designation “(N)”, standing for negligible residues, will be deleted fr ii this entry since it is no longer used by the Agency. 2/ Neat byproducts ------- -6- Dietary Assessment: The provisional acceptable daily intake (PADI) was based on a 2-year rat feeding study. The NOEL for the rat study was 5 mg/kg/day. An uncertainty factor of 1001) was used to account for the inter- and intraspecies differences and the toxicology data gaps. The PADI was obtained by dividing the NOEL by the uncertainty factor of 1000. The resultant PADI was 0.005 mg/kg/day. The theoretical maximum residue contribution (ThRC) of propanil to the daily diet of the U.S. population is 0.0015 mg/kg/day, based on the existing tolerances, with 29% of the PADI being utilized. Reported Pesticide Incidents: A well documented drift incident occurred in California where propanil was applied to extensive acreage of rice in the Sacramento Valley and resulted in phytotoxicity to plum trees up to 40 miles away. California has disallowed use of propanil in specified geographic areas, requires permits for application in other areas, and has imposed application equipment requirenents and meteorological conditions for application. Propanil is considered a “restricted herbicide” in California State Regulations. 4. Summary of Regulatory Positions The following Agency positions are summarized fran the Propanil Registration Standard. o The Agency is not initiating a Special Review of propanil at this time. o The Agency will not establish significant new food uses until residue and chronic health effects data are submitted and reviewed. o The Agency is not imposing reentry requirenents at this time. 0 Tolerances for residues in catfish and crayfish must he proposed and supporting data submitted. In lieu of proposing tolerances for catfish and crayfish, label restrictions may be ünplenented. o The Agency has determined that label restrictions on rice drainage water must be implenented. o If available rice processing studies are determined to be adequate, then the registrant must propose a method to make consistent, the feed additive tolerance and the expected residues in rice bran. o The registrant must propose a method to make consistent, the tolerance for residues in or on barley, oats and wheat straw and the expected residues for these canrnodities if available straw data for these canmodities are determined to be adequate. ------- —7— o The Agency will initiate steps to delete the designation “(N)” fran the tolerances listed in 40 CFR 180.274. o The Agency is requiring product chemistry data on each technical grade propanil product. o The Agency has determined that product chemistry and metabolism data will be immediately reviewed upon receipt. Use, Formulation or Geographic Restrictions: No significant new food or feed uses of propanil will be permitted until residue chemistry and chronic toxicology data are available to assess existing uses. Unique Label Warning Statements: End-use products shall bear the following statements as applicable: a. End-use products with aquatic uses: (1) This pesticide is toxic to fish. Drift and runoff fran treated areas may be hazardous to aquatic organisms in neighboring areas. Do not apply directly to water except as specified on this label. Do not contaminate ter by cleaning of equipment or disposal of stes. (2) Water drained fran treated rice fields must not be used to irrigate other crops or released within 1/2 mile upstream of a potable water intake in flowing water (i.e., river, stream, etc.) or within 1/2 mile of a potable water intake in a standing body of water such as a lake, pond, or reservoir. b. The following statements must appear on end-use products labeled for aquatic uses, if the registrant of the product chooses not to conduct tests and propose tolerances for catfish and crayfish: (1) Do not drain water fran treated fields into areas where catfish farming is practiced. (2) Do not apply to fields where commercial crayfish farming is practiced and do not drain water from treated fields into areas where crayfish farming is practiced. ------- -8- c. End-use products with nonaquatic uses: This pesticide is toxic to fish. Drift and runoff fr ii treated areas may be hazardous to aquatic organisms in neighboring areas. Eb not apply directly to water or wetlands (swamps, bogs, marshes, and potholes). Eb not contaminate water by cleaning of equipment or disposal of wastes. 5. Summary of Maj or Data Gaps Product thønistry All Product Cheriistry data. Residue Ehei istry Metabolism Studies (plant, livestock) Residue Analytical Method (plant and animal residues) Storage Stability Residue Studies Toxicology Acute Oral Acute Dermal Acute Inhalation Eye Irritation Dermal Irritation Dermal Sensitization 21-Day Dermal Chronic Toxicity (rodent and nonrodent) Oncogenicity (rat and mouse) General Metabolism Environmental Fate Hydrolysis Photodegradation (water and soil) Aerobic Soil Metabolism Anaerobic Soil Metabolism Anaerobic Aquatic Metabolism Aerobic Aquatic Metabolism Leaching, Adsorption/Desorpt ion Soil Dissipation ------- —9— Aquatic (Sedthient) Dissipation Rotational Crop (Confined) Acciinulat ion Irrigated Crops Accumulation Fish Accumulation Fish and Wildlife Avian Acute Oral Avian Subacute Dietary (upland game bird and waterfowl) Freshwater Fish Toxicity [ TEP] (coldwater fish and warmwater fish) Freshwater Invertebrates Acute Toxicity [ TEP] Estuarine and Marine Organisms Acute Toxicity Fish Early Life Stage and Aquatic Invertebrate Life Cycle Fish Life Cycle Plant Protection Seed Germination/Seedling Emergence Vegetative Vigor Aquatic Plant Grx.ith 6. Contact Person at EPA Robert J. Taylor U.S. &iviror nental Protection Agency Registration Division (TS-767C) 401 M Street, S.W. Washington, DC 20460 (703) 557—1800 DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational purposes only and may not be used to fulfill data requirEnents for pesticide registration and reregistration. ------- |