vvEPA Unitad Statat Environmental Pronction Agency Office of Pacticidai and Toxic Subctancas Office of Pertiada Program (TS-766C) W**nington. DC 20460 Pesticide Fact Sheet Name of Chemical: Reason for Issuance: Date Issued: Fact Sheet Number: " 30, 1. DESCRIPTION OF CHEMICAL Generic Name: Conunon Name: Trade Names: EPA Shaughnessy Code: Chemical Abstracts Service (CAS) Number: Pesticide Type: Year of Initial Registration: Chemical Family: U.S. Producer: 2-(p-tert-butylphenoxy)cyclo- hexyl 2-propynyl sulfite Propargite Omite®, Comite® and Uniroyal D014 097601 2312-35-8 Acaricide 1966 Organosulfite Uniroyal Chemical Company 2. USE PATTERNS AND FORMULATION Application Sites; Terrestrial food crops (field, vegetable, and orchard crops); terrestrial nonfood crops (ornamentals), aquatic food crop (cranberry); and greenhouse nonfood crops (ornamentals). Types of Formulations: Single active ingredient (a.i.) formu- lations consist of 4% dust; 3% and 30% wettable powders; 5, 6 and 6.55 pounds per gallon emulsifiable concentrates; The technical formulation is 85% a.i., and the formulation intermediate is 25% ct.i. Types and Methods of Application: End-use product is applied foliarly using air and/or ground equipment (including air blast) . ------- —2— Application Rates : Application rate ranges from 0.75 to 6.75 lb active ingredient per acre. Usual Carrier : Water 3. SCIENCE FINDINGS Summary Science Statement : Propargite is not considered at this time to be oncogenic. Propargite has a low acute (Category III) oral, dermal, inhalation toxicity. It is in toxicity category I however, for primary eye and primary skin irritation, and cases of severe dermatitis afflicting workers reentering treated sites have been reported. Chronic testing reveals that propargite appears to have little effect on laboratory animals except at higher dosage levels; effects reported include depressed body weights and rates of weight gain. Oral subchronic test results appear to parallel those for chronic testing. Propargite is not teratogenic in rabbits and rats. Insuf- ficient data exist to fully assess the dermal sensiti- zation, subchronic dermal toxicity, subchronic inhalation toxicity, and mutagenicity of propargite. Additional metabolism testing is also necessary. Propargite is relatively nontoxic to honey bees and avian species. It is very highly toxic to freshwater fish. The actual threat to aquatic organisms at this time cannot be accurately assessed due to the insufficiency of environmental fate data. Field monitoring data to determine propargite residues in water from terrestrial applications is needed as is additional testing to determine the effects of end—use products on coldwater and warmwater species of fish, aquatic invertebrates, and estuarine and marine organisms. The metabolism of propargite in both plants and animals is not sufficiently understood; additional metabolism data are necessary. Storage stability data are also necessary, as well as additional crop residue data and processing studies for certain crops registered for propàrgite use. CHEMICAL CHARACTERISTICS Physical State: Viscous liquid. Color: Dark amber Odor: Faint solvent odor to very faint solvent odor. Density: Specific gravity = 1.085 — 1.115 at 25°C; Bulk density = 40.92 lb/ft. ------- —3— Solubility: In water, about 0.5 ppm at 25°C, miscible with organic solvents such as acetone, benzene, and ethanol. Stability: No evidence of breakdown in one year. Flash Point: At least 38.5°C TOXICOLOGICAL CHARACTERISTICS Acute Effects Adequate data are not available to fully assess the toxi- city of Propargite. While, in general, propargite is not highly toxic (Category III oral, derrnal and inhalation), it is in toxicity Category I for primary eye and skin irri- tation. Available data present only supplementary informa- tion (as set forth below), and additional data must be submitted. Acute Oral Toxicity (Rat): 2.2 g/kg Acute Dermal Toxicity (Rabbit): 3.16(1.63—6.15) mi/kg Acute Inhalation: > 2.5 mg/i Primary Eye Irritation: Corneal effects that were not reversible after 14 days were observed in four of six rabbits. Dermal Sensitization: Inconclusive Subchronic Dermal Toxicity: Inconclusive Chronic Effects Teratogenicity (Rabbit): Maternal NOEL = 2 mg/kg/day Maternal LEL = 6 mg/kg/day (reduced body weight gain) Developmental Toxicity NOEL= 2 mg/kg/day; Developmental (increased resorption, reduced body weight, and delayed ossification). A/D ratio = maternal LEL/Develop- mental = 2/2 = 1 3—Gen. Reproduction (Rat): NOEL > 300 ppm. Additional data is required. Only one dose used throughout the study. ------- —4— Mutagenicity: Inconclusive. Additional cate- gories of mutageniCity testing are required. Chronic Feeding! Oncogenicity (Dog): NOEL = 900 ppm (HDT). No adverse effects were observed by the hematology, blood chemistry determinations or urine examinations. Feeding/Oncogenicity: Inconclusive. The study is classified as Supplementary because too few animals were examined histologically at 900 and 2000 ppm. This study needs to be repeated. Metabolism: Inconclusive. Additional data is required. OTHER TOXICOLOGICAL EFFECTS Propargite is not an organophosphate chemical; therefore, it does not have a neurotoxic potential, and a neurotoxicity study is not required. MAJOR ROUTES OF EXPOSURE There is a potential for dermal, ocular and inhalation expo- sure from mixing concentrates and applying spray mixtures. PHYSIOLOGICAL AND BIOCHEMICAL BEHAVIOR CHARACTERISTICS Foliar bsorption: Data are not available to eval- uate the effects of propargite - in plants. Translocation: Data are not available to evaluate the translocation in plants. Mechanism of Pesticidal Actions: Mode of activity involves residual killing action ENVIRONMENTAL CHARACTERISTICS Available data are insufficient to fully assess the environ- mental fate of propargite. From the data that exists, however, there seems to be no reason for concern about the leaching of the parent chemical into groundwater. ------- —5— ECOLOGICAL CHARACTERISTICS Avian Oral Toxicity: Avian Dietary Toxicity: Avian Reproduction: Freshwater Fish Toxicity: Aquatic Invertebrates (freshwater): Mallard duck — > 4640 ppm •Bobwhite quail 3401 ppm Mallard duck — > 4640 ppm Data are inconclusive to deter- mine the effects on avian reproduction. Additional data are required. Bluegill Sunfish — 0.167 ppm Rainbow trout — 0.118 ppm Daphnia rnagna — 0.092 ppm Aquatic Invertebrates (lifecycle) Daphia rnagna — 0.009 — 0.014 ppm Available data indicate that propargite is practically nontoxic to avian species. Propargite is highly toxic to fish. TOLERANCE ASSESSMENT Tolerances have been established in raw agricultural commodities, and meat by—products (40 CFR 180. Commodity Almonds Almonds, hulls Apples Apricots Beans, dry Beans, succulent CattreT fat Cattle, MBYP Cattle, meat Corn, fodder Corn, forage Corn, fresh (md. sweet) (K+CWHR) Corn, grain Cottonseed Cranberries Eggs Figs (fresh) for residues of propargite milk, eggs, meat, fat 259) 0.1 55.0 3.0 7.0 0.2 20.0 0.1 0.1 0.1 10.0 10.0 0.1 0.1 0.1 10.1 0.1 3.0 Parts Per Million (ppm ) ------- —6— Comniodity Parts Per Million (ppm ) Goats, fats 0.1 Goats, meat 0.1 Grapefruit 5.0 Grapes 10.0 Hogs, fat 0.1 Hogs, meat 0.1 Hops 15.0 Horses, fat 0.1 Horses, MBYP 0.1 Horses, meat 0.1 Lemons 5.0 Milkfat (0.08 in whole milk) 2.0 Mint 50.0 Nectarines 4.0 Oranges 5.0 Peaches 7.0 Peanuts 0.1 Peanuts, forage 10.0 Peanuts, hay 10.0 Peanuts, hulls 10.0 Pears 3.0 Plums (fresh prunes) 7.0 Potatoes 0.1 Poultry, fat 0.1 Poultry, MBYP 0.1 Poultry meat 0.1 Sheep, fat 0.1 Sheep, MBYP 0.1 Sheep, meat 0.1 Sorghum, fodder 10.0 Sorghum, forage 10.0 Strawberries 7.0 Tea (dry) 10.0 Walnuts 0.1 Results of the Tolerance Assessment : Because chronic feeding! oncogenieity and reproduction studies are needed, the current PADI is set on a 2—year dog feeding study a systemic NOEL at the highest dose tested (900 ppm). At the highest dose tested, there were no effects observed. With a safety factor of 1000, the TMRC is currently 112% of the PADI. The TMRC, however, is based on the assumption that 100% of the crop for which a tolerance is established is treated with propargite, which is not the case. If the TMRC is adjusted to reflect the actual percentage of crop treated, the TMRC would be reduced to a percentage level of the PADI signif i— cantly lower than 112%. Therefore, the public should be in no danger from dietary exposure while the Agency awaits data. ------- —7— SUMMARY OF REGULATORY POSITIONS AND RATIONALES The following are warning statements that must be included on propargite pesticide labels. MANUFACTURING USE PRODUCTS Under the Environmental Hazard Statement, add the following precaution: “This pesticide is toxic to fish. Do not discharge effluent containing this product into lakes, streams, ponds, estu- aries, oceans, or public water unless this product is specifically identified and addressed in an NPDES permit. Do not discharge effluent containing this product into sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office of the EPA.” Protective Clothing Statement “Mixer/loaders must wear goggles or a face shield, chemical— resistant apron, long-sleeved shirt and long pants or coveralls, and mid—forearm to elbow length chemical—resist- ant gloves when mixing, loading, or otherwise handling the concentrate.” END-USE PRODUCTS Products with Aquatic Use(s) : Under the Environmental Hazard Statement, add the following precaution: “This pesticide is toxic to fish. Do not apply directly to watet except as specified on this label. Drift and runoff from treated areas may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water by cleaning of equipment or disposal of wastes.” Products zith Terrestrial Use(s) : Under the Environmental Hazard Statement, add the following precaution: “This pesticide is toxic to fish. Do not apply directly to water or wetlands (swamps, bogs, marshes, and potholes). Drift and runoff from treated areas may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water by cleaning of equipment or disposal of wastes.” Reentry Statement (For All Products with Crop Uses ) “Do not allow worker reentry into treated fields within 3 days of application, for strawberries, and within 7 days, for all other agricultural uses of propargite, unless ------- —8— appropriate protective clothing is worn. Protective cloth- ing means at least a hat or other suitable head covering, a long—sleeved shirt and long—legged trousers or a coverall— type garment (closely woven fabric covering .the body, including the arms and legs), chemical—resistant gloves, socks, and shoes.” Crop Rotation Statement “Do not plant any food or feed crop in rotation within 6 months after last application of propargite unless the crop is a registered use for propargite.” Irrigated Crops Statement “Do not use water leaving propargite treated fields to irri- gate crops used for food or feed that are not registered for use with propargite.” Protective Clothing Statement “Mixer/loaders must wear goggles or a face shield, chemical— resistant apron, long—sleeve shirt, long pants, and mid—forearm to elbow length chemical—resistant gloves. Applicators must wear a long—sleeve shirt and long pants, and chemical—resistant gloves while applying this pesticide. Applicators must also wear a wide—brimned hat during upward directed spraying. Any article of clothing worn while applying product must be cleaned before re—use. Clothing should be laundered separ- ately from household articles. Clothing that has been drenched or has otherwise absorbed concentrated pesticide must be disposed of in a sanitary landfill, incinerated, or burned if allowed by State and local authorities.” - Endangered Species Statement (For Products with Use on Terrestrial and Aquatic Food Crops, by February 1988 ) “The use.of any pesticide in a manner that may kill or otherwise harm an endangered or threatened species or ad- versely modify their habitat is a violation of Federal laws. The use of this product is controlled to prevent death or harm to endangered or threatened species that occur in the following counties or elsewhere in their range. Before using this pesticide in the following counties, you must obtain the EPA Cropland Endangered Species Bulletin. The use of this pesticide is prohibited in these counties unless specified otherwise in the Bulletin. The EPA Bulletin is available from either your local pesticide distributor, your County Agricultural Extension Agent, the Endangered ------- —9— Species Specialist in your State Wildlife Agency Head- quarters, or the appropriate Regional Office of the U.S. Fish and Wildlife Service (FWS). THIS BULLETIN MUST BE REVIEWED PRIOR TO PESTICIDE USE. ” 5. SUMMARY OF MAJOR DATA GAPS The following list presents data required and the due date for submission of this data: Product Chemistry Due Dates Product Chemistry Feb 1987 Residue Chemistry Plant/Livestock Metabolism Feb 1988 Plant/Animal Residues Feb 1988 Storage Stability Feb 1988 Toxicology Sensitization Study July 1987 Subchronic Dermal Toxicity (21 days) May 1987 Subchronic Inhalation Toxicity (90 days) May 1987 Metabolism Sept 1988 Mutagenicity Sept 1987 Chronic Feeding/oncogencity Dec 1990 Two-Gen. Reproduction Dec 1989 Environmental Fate Soil Dissipation (Field) Dec 1988 Aquatic (Sediment) Dec 1988 Rotational Crops (Confined) DeC 1989 Rotational Crops (Field) Nov 1990 Irrigated Crops Dec 1989 Fish (Accumulation Studies) Sept 1987 HydrolysTh/PhOtOdegradatiOrl July 1987 Aerobic Soil Metabolism Dec 1988 Anaerobic Soil Metabolism Dec 1988 Anaerobic Aquatic Dec 1988 Aerobic Aquatic Dec 1988 Leaching and Adsorption/DesorptiOfl July 1987 Volatility (Lab) July 1987 Foliar dissipation (Reentry) Nov 1987 Soil Dissipation (Reentry) Nov 1987 Glove Permeability Nov 1987 ------- —10— Summary of major data gaps (continued) Ecological Effects Residue Level Monitoring (Aquatic) Feb 1988 Avian Reproduction Sept 1988 Freshwater Fish (Warmwater) July 1987 Freshwater Fish (Coidwater) July 1987 Acute LC 50 Freshwater (Invertebrates) July 1987 Acute LC 50 Estuarine & Marine Organisms (Shrimps) July 1987 (Fish) July 1987 (Mollusk) July 1987 6. CONTACT PERSON AT EPA George T. LaRocca U.S. Environmental Protection Agency TS—767C 401 M Street, S.W. Washington, D.C. 20460 (703) 557—2400 DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational purposes only and may not be used to fulfill data requirements for pesticide registration and reregistration. ------- |