United Statai Office of Pwtlctdat end Toxic Sutatances Environmental Protection Office of Pesticide Programs (TS-766CI Agency Washington, DC 20460 v>EPA Pesticide Fact Sheet Name of Chemical: CHLORPYRIFOS Reason for Issuance: Date Issued: September 30, 1984 Fact Sheet Number: 37 DESCRIPTION OF CHEMICAL Generic Name: 0,0-diethyl 0-(3,5,6-trichloro-2-pyridyl) phosphorothioate Common Name: Chlorpyrifos Trade Name: Dursban for household products, Lorsban for agricultural products EPA Shaughnessy Code: 059101 Chemical Abstracts Service (CAS) Number: 2921-88-2 Year of Initial Registration: 1965 Pesticide Type: Insecticide Chemical Family: Organophosphate U.S. and Foreign Producers: Dow Chemical U.S.A. Makhteshim-Beer Shviva All India Medical Corp Planters Products, Inc. USE PATTERNS AND FORMULATIONS Application Sites: Grain crops, nut crops, bananas, cole crops, citrus, pome and strawberry fruits, forage, field and vegetable crops, lawns and ornamental plants, poultry, beef cattle, sheep and dogs, livestock premise treatment, domestic dwellings, terrestrial structures, and direct ap- lication to stagnant water etc. Types of Formulations: Baits, dusts, granules, wettable powders, flowables, impregnated plastics and pressurized liquids. Types of Methods of Application: Ground and aerial, sprays and dust applications Application Rates: Range from 0.5 Ibs. a.i./A to 3 Ibs. a.i./A and crack and crevice treatment to broadcast treatment for indoor uses. ------- 2 Usual Carriers: Synthetic clays, talc, various solvents 3. SCIENCEYINDINGS Summary Science Statement Chiorpyrifos has moderate mammalian toxicity. It is not considered to be oncogenic, mutagenic or teratogenic. However, the oncogenicity and mutagenicity studies used to draw these conclusions are not up to current Agency standards. Additional information from these studies is required. The Agency is imposing a 24—hour reentry restriction for crop uses until appropriate reentry studies are submitted and evaluated and a decision is reached whether a different time interval is more appropriate. The 24—hour interval also coincides with the requirements of California. Data are insufficient to fully assess the environmental fate of chlorpyrifos. The Agency is requesting necessary data to make this assessment and also to specifically assess whether or not chlorpyrifos has a potential to leach into groundwater. Data are also insufficient to measure human exposure in outdoor and indoor applications. Chlorpyrifos is extremely toxic to tish, birds and other wildlife. It is highly toxic to honey bees. Use precautions and restrictions are being imposed to reduce potential hazards. A full tolerance reassessment cannot be completed. The previous ADI (at 94% of the TMRC) was established based on a 2—year rat feeding study. The present ADI (313% of the TMRC) was calculated using a human study. Chronic feeding studies are required as well as metabolism and residue data on numerous commodities. Chemical Characteristics Physical State: Crystalline solid Color: White to tan Odor: Mild mercaptan Melting point: 41.5—43.5 °C Vapor Pressure: 1.87 x lO mm Hg at 20°C Flash Point: None ------- 3 Toxicology Characteristics Acute Oral: 163 mg/kg, Toxicity Category II Acute Dermal: 1505 mg/kg, Toxicity Category II Primary Dermal Irritation: No irritation, Toxicity Category III Primary Eye Irritation: Conjunctival irritation at 24 hours. Cleared at 48 hours. Toxicity Category III Acute Inhalation: Data gap Neurotoxicity: Not an acute delayed rieurotoxic agent at doses up to 100 mg/kg (highest dose tested). Oncogenicity: Two studies submitted but neither meet Agency standards. Neither suggest oncogenicity potential. Teratogenicity: Three studies have been evaluated to deter- mine the teratogenic potential of chlorpyrifos. The Agency has determined that this chemical is not teratogenic at levels up to 25 mg/kg/day. Reproduction—2 generation: Two studies adequately demon- strate that chlorpyrifos does not produce reproductive effects. No effects were demonstrated at dose levels up to 1.2 mg/kg/day. Metabolism: The submitted studies suggest that chlorpyrifos is rapidly absorbed and metabolized to 3,5,6—trichloro—2—pyri= dinal (TCP). The parent compound and metabolite are rapidly excreated in the urine. The submitted studies do not meet Agency standards. Mutagenicity: Data Gap Physiological and Biochemical Behavioral Characteristics Mechanism of Pesticidal Action: An insecticide which is active by contact, ingestion, and vapor action and almost irreversibly causes phosphorylation of the acetylcholin— esterase enzyme of tissues, allowing accumulation of acetyl— chloline at cholinergic neuroeffector junctions (muscarinic effects), and at skeletal muscle myoneural junctions and autonomic ganglia. Poisoning also impairs the central nervous system function. Symptoms of poisoning include: headache, dizziness, extreme weakness, ataxia, tiny pupils, twitching, tremor, nausea, slow heatbeat, pulmonary edema, and sweating. Continual ------- 4 absorbtion at intermediate dosages may cause influenza—like illness which includes symptoms like weakness, anorexia, and malaise. Metabolism and Persistence in Plants and Animals : The metabolism of chiorpyrifos in plants and animals is not adequately understood. The major metabolite is 3,5,6— trichloro—2—pyridinol (TCP). The Agency does not have adequate data on TCP to determine if this metabolite should continue to be a part of the tolerance expression. Environmental Characteristics Available data are insufficient to fully assess the environ- mental fate of chiorpyrifos. Data gaps exist on all required studies except for aerobic and anaerobic soil studies. Adsorption and Leaching in Basic Soil Types: The Agency is requesting data to determine if chlorpyrifos will contaminate groundwater. Microbial Breakdown: Depending on the soil type, microbial metabolism of chlorpyrifos may have a half—life of up to 279 days. Ecological Characteristics Avian oral: Mallard duck——76.6 mg/kg Ring necked pheasarit——17.7 mg/kg Avian dietary: Mallard duck——136 ppm Bobwhite quail——721 ppm Freshwater Fish: Coldwater fish (rainbow trout)——3.O ppm Warmwater fish (bluegill sunfish)——2.4 ppm Acute Freshwater Invertebrates: Daphnia——O.176 ppb Acute Estuarine and Marine Organisms: Oyster——O.27 ppm Grass shrimp——l.5 ppm Killifish——3.2 ppm Precautionary language is being required for hazards to birds, fish, and aquatic organisms. Chronic effects to non—target aquatic invertebrate species are not adequately characterized and therefore appropriate studies are required. ------- 5 Tolerance Assessment The Agency is unable to complete a full tolerance reassess- ment because of certain residue chemistry and toxicology data gaps. Tolerances: Commodity Parts Per Million Alfalfa, green forage 4.0 Alfalfa, hay 15.5 Almonds 0.05 Almonds, hull 0.05 Apples 1.5 Bananas (whole) 0.25 Bananas, pulp with peel removed 0.05 Bean forage 1.0 Beans, lima 0.05 Beans, lima, forage 1 Beans, snap 0.05 Beans, snap, forage 1 Beets, sugar, roots 1.0 Beets, sugar, tops 8.0 Broccoli 2 Brussels sprouts 2 Cabbage 2 Cattle, fat 2.0 Cattle, meat by—products (mbyp) 2.0 Cattle, meat 2.0 Cauliflower 2 Cherries 2.0 Citrus fruits 1.0 Corn, field, grain 0.1 Corn, fresh (inc. sweet corn; kernel 0.1 plus cob with husk removed) Corn, fodder 10.0 Corn, forage 10.0 Cottonseed 0.5 Cranberries 1.0 Cucumbers 0.1 Eggs 0.1 Figs 0.1 Goats, fat 1.0 Goats, mbyp 1.0 Goats, meat 1.0 Grapes 0.5 Hogs, fat 0.5 Hogs, mbyp 0.5 Hogs, meat 0.5 Horses, fat 1.0 Horses, mbyp 1.0 ------- 6 Tolerances (con’t) Commodity Parts Per Million Horses, meat 1.0 Milk, fat (reflecting 0.02 ppm 0.5 in whole milk) Mint, hay 1.0 Nectarines 0.05 Onions (dry bulb) 0.5 Pea forage 1.0 Peaches 0.05 Peanuts 0.5 Peanut hulls 15 Pears 0.05 Peppers 1.0 Plums (fresh prunes) 0.05 Poultry, fat (inc turkeys) 0.5 Poultry, mbyp (inc turkeys) 0.5 Poultry, meat (inc turkeys) 0.5 Pumpkins 0.1 Radishes 3 Seed and pod vegetables 0.1 Sheep, fat 1.0 Sheep, mbyp 1.0 Sheep, meat 1.0 Sorghum, fodder 6 Sorghum, forage 1.5 Sorghum, grain 0.75 Soybeans 0.5 Soybeans, forage 8.0 Soybeans, straw 15.0 Strawberries 0.5 Sunflower, seeds 0.25 Sweet potatoes 0.1 Tomatoes 0.5 Turnips (roots) 3 Turnips (greens) 1 Based on established tolerances the theoretical maximum residue contribution (TMRC) for chiorpyrifos residues in the human diet is calculated to be 0.5637 mg/day. The acceptable daily intake (ADI) of chiorpyrifos is 0.003 mg/kg/day. The maximum permissible intake (MPI) is 0.18 mg/day. The percent utilized ADI is 313%. To provide for conformity between U.S. tolerances for chiorpyrifos and tolerances established by the Codex Alimentarius , Canada and Mexico, the expres- sion of the U.S. tolerances for chiorpyrifos would have to exclude the major metabolite TCP, but the Agency is not recommending this now. ------- 7 U.S. tolerances for most raw agricultural commodities are supported by current residue chemistry data. In some cases however, more data are required. 4. SUMMARY OF REGULATORY POSITION AND RATIONALE The Agency has determined that it should continue to allow the registration of chiorpyrifos. Adequate studies are available to assess the acute toxicological effects of chiorpyrifos to humans. None of the criteria for unreason- able adverse effects listed in section 162.11(a) of Title 40 of the U.S. Code of Federal Regulations have been met or exceeded. However, because of certain gaps in the data base a full risk assessment of chlorpyrifos cannot be completed. Also, a full tolerance reassessment cannot be completed because of certain residue chemistry and toxicology data gaps. The Agency is concerned whether or not the potential total human exposure to chiorpyrifos and its metabolites, from its widespread use and its ADI being exceeded three—fold, poses any unacceptable hazards. To resolve this concern, additional residue, metabolism and exposure data are required, and until it is resolved no significant new tolerances or uses will be granted. A federal 24—hour reentry interval is established for treated crop areas until reentry data are submitted, as required, and the Agency decides on the most appropriate time interval. Available data are insufficient to fully assess the environ- mental fate of chlorpyrifos. The Agency is requesting data to determine if chlorpyrifos will contaminate groundwater. 5. SUMMARY OF MAJOR DATA GAPS Additional residue data on various processed commodities are being required. Also, additional chronic toxicity, oncogen— icity and mutagenicity testing is needed to better define the long term effects of this chemical. Plant, animal and exposure data are required to better qualify and quantify human exposure to residues from dietary and nondietary sources. Other requirements: Acute inhalation General metabolism Hydrolysis study Photodegradat ion studies Soil metabolism studies Mobility studies Dissipation studies ------- 8 Other Requirements (con’t) Accumulation studies Fish embryo—larvae study Large scale field testing Monitoring for crop runoff Phytotoxic effects on algae and other aquatic plants Indoor monitoring 6. CONTACT PERSON AT EPA Jay S. Ellenberger Product Manager (12) Insecticide—Rodenticide Branch Registration Division (TS—767C) Office of Pesticide Programs Environmental Protection Agency 401 M Street, S. W. Washington, D. C. 20460 Office location and telephone number: Room 202, Crystal Mall #2 1921 Jefferson Davis Highway Arlington, VA 22202 (703) 557—2386 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 rereg istrat ion. ------- |