oYc U*"t«d St»t«i Otllci of Panicidai and Toxic Subtuneai Environmental Protection Offlot of P«tidd« Program* (TS-7MCI A«tncy Wvhington, DC 20460 vvEPA Pesticide Fact Sheet Name of Chemical: dichlorvos Reason for Issuance: registration standard Date Issued: io/87 Fact Sheet Number: 1. DESCRIPTION OF CHEMICAL Generic Name: 2,2-dichlorovinyl dimethyl phosphate (Chemical) hexahydro-4,7-methanoindene Common Name: Dichlorvos Trade and Other Names: 2,2-dichloroetheny1 dimethyl phosphate; DDVP (USA); DDVF (USSR). Nogos; Vapona; Dedevap; Matu; Oko; Atgard; No-pest; Herkol; Ciovap; Ravap; Vaponite; Canogard; Equigard; Task and Riton. EPA Shaughnessy Code: 084001 Chemical Abstracts Service (CAS) Number: 62-73-7 Year of Initial Registration: 1948 Pesticide Type: Insecticide Chemical Family: Organophosphate U.S. and Foreign Producers: Amvac Chemical Corp.; SDS Biotech Corp.; Prentiss Drug and Chemical Co.; Dow Chemical Corp; Kaw Valley; MGK Co.; Denka Chemia B.V.; Kenco Chemical and Mfg. Corp.; Wesley Industries. Inc; Fermenta Animal Health; and E.I. du Pont de Nemours and Company ------- 2 2* USE PATTERNS AND FORMULATIONS Application Sites: Dichlorvos is used in areas where flies, mosquitoes, gnats, cockroaches and other nuisance insect pests occur. Use sites include the following: in and around domestic dwellings (contract, crack and crevice, bait, resin strip, and space spray); direct application to domestic food animals (spray, pour-on, dip, back rubber, face oiler, and pa int and impregnated material); direct application to domestic animals (spray, flea collar, and tag); in and around premises housing animals (food and nonfood) (space spray, bait, resin strip, and contact); ornamental and food crop greenhouse use (contact and space spray); mushroom houses (contact and space spray); tobacco warehouses (contact and space spray); postharvest tomato treatment (dust applied to fruit in containers); sewage plants/sewage systems (resin strips and direct applica- tion to sewage); aircraft, buses and other commercial transportation vehicles (space spray); nonperishable bulk-stored raw agricultural commodities (RACs) (including animal feed, beans [dried type], cocoa beans, coffee beans, grain crops such as corn, nut crops, peanuts, peas [field], soybeans, and tobacco) (resin strip and space spray); nonperishable packaged or bagged RACs (including beans (dried type], cocoa beans, coffee beans, grain crops such as corn, nut crops, peanuts, peas, and soybeans) (space spray); non- perishable packaged or bagged processed agricultura1 commodities (including cereals, crackers, flour, packaged cookies, and sugar); lawns (foliar application); ornamental turf (foliar application); ornamental plants (foliar and bark application); noncrop aquatic areas (ground or air equipment and resin strip); ------- 3 eating establishments, and food processing and storage areas (space spray, contact, bait, and resin strip); other commercial, institutional and industrial areas (space spray, contact bait, and resin strip); enclosed outdoor utility equipment (space treatment); gypsy moth traps and malaise (tent) traps (resin strip); figs (EPA SLN No. CA-830045) (ground and air equip- ment); urban and rural outdoor areas (food and nonfood); including screwworm adult suppression (EPA SLN Nos. TX-780056, AZ-8003100, NM-790003, CA-810040) and recreational areas (spray, bait, and resin strip); and miscellaneous sites including epcot display crops (EPA SLN Nos. FL-8 20051, FL-820054, FL-820055), rat receptacle bags, refuse and solid waste containers and sites (spray, bait, and resin strip). Formulation Types: Emulsifiable concentrates, soluble concentrate liquids, granulars, pressurized liquids and dusts, impregnated materials, pellets/tablets, liquids (ready to use), wettable powders and dusts. 3. SCIENCE FINDINGS Summary Science Statement Dichlorvos is an organophosphate insecticide with moderate to high acute toxicity. Dichlorvos is classified as a B2 "Probable Human Carcinogen", is a potent cholinesterase inhibitor, and may cause liver effects from subchronic and chronic exposure. Dichlorvos is potentially highly to very highly toxic to fish and other wildlife. It may have the capacity under various use patterns, i.e., fig and mosquito larvicide use, to cause adverse effects to aquatic invertebrates, fish, and birds. Dichlorvos degrades fairly rapidly in soil and water and is therefore not expected to reach groundwater. However, the environmental fate is largely uncharacterized, and additional data are needed before definitive conclusions are reached. A tolerance reassessment of dichlorvos is not possible because of gaps in the toxicology data base and because many of the tolerances are not adequately supported. ------- 4 Chemical/Physical Characteristics of the Technical Material Physical State: Liquid Color: Colorless to light amber Molecular Weight and Formula: 221.0 - C4H7CI2O4P Boiling Point: 117" C at 10 mm Hg Specific Gravity: 1.42 at 25* C Density: 1,65-1.67 g/ml Vapor Pressure: 0.032 mm Hg at 32 "C Solubility in Various Solvents: Slightly soluble in water and kerosene; readily solu- ble in most organic solvents Stability: Stable in the presence of hydrocarbon solvents; undergoes hydrolysis in the presence of water and is readily decomposed by strong acids and bases Miscibility: Miscible with most organic solvents and aerosol propellants Corrosion Characteristics: Corrosive to steel,* noncorrosive to stainless steel, aluminum, nickel, Hostelloz 13, Teflon Chemical Relationships5 Trichlorfon and naled are chemically related to dichlorvos. Naled degrades to dichlorvos in plants, animals, and soi1. In cattle and poultry, naled is debrominated to dichlorvos which furth' degrades to dichlorodesmethyl-dichlors (major pathway) or desmethyl-dichlorvob (minor pathway). Trichlorfon degrades to dichlorvos in soil and alkaline pond water, and possibly in plants and animals. Toxicology Characteristics Acute Oral: Toxicity Category II (56 and 80 rag/kg in female and male Sherman rats, respectively). Acute Dermal: Toxicity Category I (75 and 107 mg/kg in female and male Sherman rats, respectively). Primary Dermal Irritation: Toxicity Category IV based on mild dermal irritation reported in a rabbit study. Primary Eye Irritation: Toxicity Category III based on a lack of corneal injury and only mild redness and chemosis at 24 hours postapplication of 1.67 mg/kg technical dichlorvos in rabbits' eyes. Skin Sensitization: Data Gap ------- 5 Acute Inhalation: Toxicity Category I based on a toxicity value of >193 mg/m3 in rats. Delayed Neurotoxicity: Data Gap Subchronic Oral (rodent) Testing: Data Gap Oncogenicity: Classified as a B2 "probable human carcinogen" This determination for oncogenicity is based on a draft report of a review of two rodent studies sponsored by the National Toxicology Program in which there were significantly increased incidences of forestomach squamous cell carcinoma/papillomas in female mice and pancreatic acinar adenomas, mononuclear cell leukemia and lung adenomas in male rats ana mammary gland fibroadenomas in female rats. The potency or is 2.9 x 10-1 (mg/kg/day). Chronic Feeding: Based on a dog chronic feeding study with increased relative liver weights in males at 32 ppm and above, and enlargement of liver cells in both sexes at 32 ppm and above, the no-observable-effect level (NOEL) is 0.0b mg/kg/day (3.2 ppm). A rodent feeding study is required. Metabolism: Data Gap Teratogenicity: Rodent teratology study is a data gap,- based on an acceptable rabbit teratology study by inhalation, the NOEL for embyro/fetotoxicity is 2 ug/L based on decreased fetal weights. Data Gap Dichlorvos is a direct-acting (gene) mutagen, in bacteria, fungi, and mammalian cells in vitro. Dichlorvos was shown to be negative in micronucleus and sister-chroraatid exchange assays conducted in mice, and was also negative in repeated dominant lethal assays. Major Routes of Exposure: Dermal and respiratory exposure to mixers, loaders, applicators, reentry workers and occupants of treated buildings. Reproduction: Mutagenicity: ------- 6 Environmental Characteristics Numerous data gaps exist for environmental fate. Data reviewed by the Agency indicate that dichlorvos degrades fairly rapidly with half-lives of 2 to 8 hours in soils ranging in texture from sand to silt. The mobility of dichlorvos is inversely correlated with soil organic matter content. Preliminary data also suggest that dichlorvos is intermediately to very mobile in a variety of soils ranging in texture from sandy loam to clay. Groundwater contamination may not be a problem because of dichlorvos's rapid degradation. However, acceptable data are lacking, and are needed before the Agency can assess the potential for dichlorvos to contaminate groundwater. Ecological Characteristics (technical grade) Avian oral toxicity: Data Gap Avian dietary toxicity: Acute toxicity values greater (8-day) than 1317 and 5000 ppm for mallard ducks at 5 and 16 days of age, respectively; for phea- sants the acute toxicity value is 568 ppm. Freshwater fish acute toxicity: 0.1 ppm for rainbow (96-hr. LC50) trout; 0.23 ppm for striped mullet. Estuarine/marine fish acute toxicity: 0.23 for striped mullet Freshwater invertebrate toxicity: 0.00007 ppm for Daphnia (48-hr. or 96 hr. EC50) pulex; 0.004 ppm for sand shrimp. Estuarine/marine invertebrate toxicity: 0.0004 ppm for sand shrimp Tolerance Reassessment Analytical methodology for determining the levels of residues of dichlorvos in plants and animals is adequate for data collection of residues in plant commodities and in animal tissues and milk. Storage stability data demonstrate that residues of dichlorvos in or on frozen plant samples are stable up to 90 days after application. Residues in or on frozen animal tissues are stable up to 8 weeks after application. Additional storage data (length of time and conditions under which samples were stored) are required ------- 7 in order to evaluate the adequacy of the dichlorvos tolerances. If previously submitted samples or newly generated samples were/are stored frozen for greater than 90 days (plants) or 8 weeks (animals), additional storage stability data will also be needed. Data on the magnitude and levels of residues of dichlorvos in radishes, lettuce, tomatoes, cucumbers, milk, eggs, and the meat, fat, and meat byproducts of cattle, goats, hogs, horses, sheep, and poultry are insufficient to determine the adequacy of the established tolerances. Tolerances for residues of dichlorvos in or on figs, dried figs, and mushrooms are adequately supported. Data are required to support use of dichlorvos products in food areas of food handling establishments. Processing and cooking studies are required. Data reflecting the use of ~ dichlorvos on stored, unfinished tobacco are required. The established tolerances for residues of dichlorvos in or on bulk-stored nonperishable RACs are not adequately supported, and data are required. The established tolerances are adequate to cover residues of dichlorvos in or on packaged or bagged nonperishable RACs and processed food resulting from the application of dichlorvos vapors. However, the data indicate that residues following use of aerosol treatments will result in toleranceexceeding residues. Therefore, residue data and an accompanying tolerance revision must be submitted. Also, insufficient data are available regarding residues of dichlorvos in the meat, fat, and meat byproducts of cattle, goats, horses, sheep, and poultry and milk and eggs. This constitutes a data gap. Based on a 2-year dog feeding study with a NOEL of 0.08 mg/kg/day (3.2 ppm) for changes in liver weight and enlarged liver cells, a provisional acceptable daily intake (PADI) of 0.0008 mg/kg/day has been calculated using a one hundred-fold uncertainty factor. The calculated estimate is provisional because the existing data base for dichlorvos is lacking a chronic rat feeding study, a reproduction study and a rat teratology study. The Anticipated Residue Contribution (ARC) for dichlorvos for the U.S. population average is 0.000416 mg/kg/day based on current tolerance levels, cooking data for small grains, and an estimate of percent crop treated. The ARC occupies 52% of the PADI. For children 1 to 6 years of age, the ARC occupies 122% of the PADI. 4. SUMMARY OF REGULATORY POSITIONS AND RATIONALES * The Agency is considering further regulatory act ion for all registered uses of dichlorvos because of concerns about the risks of oncogenicitv, cholinesterase inhibition, and liver effects. The risks of concern are for the public from consumption ------- 8 risks ot oncogenicity, cholinesterase inhibition, and liver effects. The risks of concern are for the public from consumption ot foods containing residues ot dichlorvos, for those involved in the application ot dichlorvos, for workers reentering treated areas, tor residents/occupants of treated areas (including areas treated with resin pest strips or other dichlorvos products), for people exposed to pets treated with dichlorvos, and tor pets treated with dichlorvos. 0 In order to meet the statutory standard tor continued registration, the Agency has determined that all dichlorvos products (excluding domestic uses [household sprays containing 0.5% or less active ingredient], resin strips and pet uses) must be restricted for retail sale to and use by Certified Applicators or persons under their direct supervision. In view ot the potential health hazards associated with exposure to dichlorvos, the Agency is concerned about exposure to dichlorvos which may result from improper application or use ot dichlorvos products, and so is restricting use ot the pesticide. ° In order to meet the statutory standard tor continued registration, the Agency has determined that all products must contain a cancer hazard warning. The Agency believes that incorporation of this statement attords the product user with important information about the potential oncogenic hazard associated with the use of the product. ° The Agency has determined that in order to meet the statutory standard for continued registration, all dichlorvos product labels must bear protective clothing statments. ° An interim 48-hour reentry interval is imposed tor the agricultural and commercial uses ot dichlorvos until such time as appropriate reentry data have been submitted and evaluated. Exposure data are required to support registration ot total release foggers and aerosol products intended tor use in domestic dwellings. 0 Pesticide spray dritt data requirements are imposed for the fig use and outdoor aerosol and fogging mosquito use. Data required include droplet size spectrum studies and tield evaluation ot pesticide spray drift. ° The Agency is requiring a special environmental monitoring study in order to evaluate whether or not the tig and mosquito control uses ot dichlorvos may result in exposure ot certain terrestrial and aquatic organisms to potentially hazardous levels ot the pesticide. o The Agency has determined that endangered species label ------- 9 o In order to remain in compliance with FIFRA, the Agency has determined that endangered species label restrictions are necessary to protect endangered threatened species in aquatic areas. Labeling which prohibits the mosquito larvicide use of dichlorvos in the range of endangered and threatened species is required through PR Notice 87-4, which was issued in May, 1987. Additional endangered species labeling require- ments are reserved pending the results of a consultation with the Office of Endangered Species regarding use of dichlorvos on figs. * The Agency is deferring decisions concerning dichlorvos and groundwater contamination until such time as the information required by the Standard have been submitted and reviewed. No new tolerances for raw agricultural commodities or new food uses will be granted until data gaps for residue chemistry and chronic toxicology have been t ilied. All products must bear appropriate labeling as specified in 40 CFR 162.10, PR Notices 83-2, 83-3, and 87-4, precautions and warnings listed in the Dichlorvos Use Index, and as indicated in the Registration Standard. 6. SUMMARY OF OUTSTANDING DATA REQUIREMENTS Toxicology Dermal sensitization Dermal absorption 21-day dermal toxicity Neurotoxicity Subchronic oral toxicity Chronic feeding - rodent Teratogenicity - species - rodent species species other than the rabbit Reproductive effects Metabolism rats (2-generation) Time Frame 9 Months 6 " 9 " 9 " 12 " 50 " 15 " 39 " 24 " Environmental Fate/Exposure Hydrolysis study 9 Months Aerobic soil metabolism study 27 Aerobic and anaerobic aquatic metabolism study 27 " Leaching and adsorption/desorption study 12 Terrestrial field dissipation study 27 ------- 10 Aquatic (sediment) - field study 27 Photodegradation in water, soil and air 9 Volatility (lab) studies 12 Accumulation - irrigated crops 39 Reentry data 18 Dermal and inhalation Exposure 18 Spray drift data 18 Residue Chemistry Livestock metabolism (direct animal treatment) 18 Months Storage stability data 18 " Residue analytical Method 15 " Residue data {except 18 " for figs, dried figs, and mushrooms) 18 Processing and cooking studies 18 Residue data on stored, unfinished tobacco 18 " Residue data -food handling establishements 12 Product Chemistry 9-15 Months Fish and Wildlife Acute avian toxicity 9 Months Acute toxicity to fish 9 Acute toxicity to freshwater invertebrates 9 " Acute toxicity to estuarine and marine organisms 9 Fish early life stage and aquatic invertebrate life-cycle 15 " Special environmental residue monitoring study 24 " Avian reproduction 24 " Fish life cycle study 27 Honeybee - toxicity of residues on foliage 15 7. CONTACT PERSON AT EPA George LaRocca Product Manager (15) Insecticide-Rodenticide Branch Registration Division (TS-767C) Office of Pesticide Programs Environmental Protection Agency 401 M Street SW. Washington, DC 20460 Office location and telephone number: Room 204, Crystal Mall #2 1921 Jefferson Davis Highway Arlington, VA 22202 (703) 557-2400 ------- 11 DISCLAIMER: The information presented in this Chemical Information Fact Sheet is for informational purposes only and may not be used to fulfill data requirements for pesticide registration and reregistration. ------- |