United States Environmental Protection Agency Office of Paitictda and Toxic Subttanca* Office of Pestiade Programs (TS-766CI Washington. DC 20460 vvEPA Pesticide Fact Sheet Name of Chemical: Pronamide Reason for Issuance: Registration Standard Date Issued: April 1986 Fact Sheet Number: 70 DESCRIPTION OP CHEMICAL Generic Name: Common Name: Trade Name: EPA Shaughnessy Code: Chemical Abstracts Service (CAS) Number: Year of Initial Registration: Pesticide Type: Chemical Family: U.S. and Foreign Producers: 3,5-dlchloro-N(l,l-dimethyl-2- propynyl) benzamlde - or - [N-(l,l-dlmethylpropynyl)-3,5- dlchlorobenzamlde] Pronamlde (WSSA), RH-315 Kerb® 101701 23950-58-5 1972 Herbicide Substituted benzamlde Rohm and Haas USE PATTERNS AND FORMULATIONS Application sites: alfalfa, apples, globe artichokes, birds- foot trefoil, blackberries, blueberries, cherries, clover, crown vetch, endive, grapes, lettuce, nectarines, peaches, pears, plums, raspberries, sainfoin, azalea, Douglas fir, fir, forsythia, holly, Juniper, pine, rhododendron, yew, Christmas tree plantations, bermudagrass, centipede- grass, St. Augustinegrass, and zoysiagrass. Types of formulations: 9*4/6 active ingredient technical grade; 50* formulation intermediate; and 50? wettable powder, <_!% granular and <1% granular formulations mixed with fertilizer end-use products. ------- —2— Types and methods of application End-use product is applied preplant, preemergence or early postemergence by ground spray, incorporation, or aerial application. Hand spray application is limited to ornamentals and nursery stock. Application rates: 0.5 to 1 1.0 lbs. active ingredient per acre, depending on crop and weed problem. Usual carrier: Water 3. SCIENCE FINDINGS Summary science statement Pronamide has been found to be oncogenic in male mice and has been tentatively classified as a Group C oncogen (Possible Human Carcinogen), pending consideration of additional data. Acute toxicity studies indicate Toxicity Category iii.!! Pronamide is practically nontoxic to birds, mammals, and fish, and possibly as much as moderately toxic to aquatic invertebrates. Available data are insufficient to fully assess the environmental fate of pronamide. Chemical characteristics: Physical state: Crystalline solid Color: White Melting point: 155—156° C Specific gravity: 0.118 gm/cc Solubility: Solvent ppm at 25° C Dimethyl sulfoxide 33 Dimethyl formamide 33 Mesityl oxide 20 Isophorone 20 Methyl ethyl ketone 20 Cyclohexanone 20 Methanol 15 Isopropanol 15 Ch lorobenzene 12 Butyl cellosolve 10 Xy lene 10 Acetonitrile 10 Kerosene 10 Nitrobenzene 5 Ethylene dichioride 5 - Water 15 Chemicals classified as Toxicity Category III are those which are harmful if swallowed, inhaled or absorbed through the skin. Contact with skin, eyes or clothing requires immediate first-aid and may require medical attention. ------- —3 Vapor pressure 8.50 x i@—5 Torr at 25° C Stability : considered relatively stable Toxicological characteristics Acute effects. /: Acute oral toxicity (rat) — 16,000 (10,666—214,000) mg/kg Toxicity Category IV Acute dermal toxicity — greater than 10 g/kg (rabbit) Toxicity Category III Acute inhalation toxicity - greater than 3.2 mg/L (rat) Toxicity Category III Primary eye irritation — slight eye irritant (rabbit) Toxicity Category III Primary skin irritation — not a primary dermal Irritant (rabbit) Toxicity Category IV Dermal Sensitization — technical material Is not a (guinea pig) skin sensitizer Toxicity Category IV Subchronlc efCects: Feeding study (dog) - Lowest effect level (LEL) is 14050 ppm (approximately 90 mg/kg/day) NOEL is 1350 ppm (approximately 3fl mg/kg/day) Chronic effects Chronic feeding (rat) — NOEL Is 300 ppm (highest dose tested) (15 mg/kg) Chronic feeding (dog) — IOEL Is 7.5 mg/kg Teratology (rabbits) — Maternal NOEL 5 mg/kg/day LOEL 20 mg/kg/day Developmental LOEL 80 mg/kg/day NOEL 20 mg/kg/day Oncogeniclty (mice) — Positive 1’ Toxicity Category III = Harmful if swallowed, inhaled or absorbed through the skin. Contact with skin, eyes or clothing requires immediate first aid and may required medical attention. Toxicity Category IV = No precautions are required. ------- —L I Major route of exposure Mixers and applicators would be expected to receive the most exposure via skIn contact. Physiological and biochemical behavorial characteristics Poliar absorption: To obtain activity, pronamide must move into the root zone of the weeds. Little activity is obtained from foliar contact alone. Trarislocation: Pronamide is readily absorbed by plants through the root system, translocated upward, and distributed into the entire plant. The degree of translocation from leaf absorption is not appreciable. Mechanism of pesticidal action: Pronamide appears to act as a cell division inhibitor. Its main acttvity Is against root development in germinating seeds or young seedlings, or, in the case of perennial grasses, against both root and vegetative bud development. Pronamide is taken up by the roots and needs to be carried into the root zone by rainfall, irrigation or incorporation. Environmental characteristics: Available data are insuffic— lent to fully assess the environmental fate of’ pronamide. Pronamlde is stable to hydrolysis at pH 1 1.7—8.8. Ecological characteristics: Results or studies indicate that pronainide is practically nontoxic to birds, mammals, and fish, and possibly as much as moderately toxic to aquatic invertebrates. These results are: Aquatic invertebrate - Greater than 5.6 ppmi/ toxicity ( Daphnia magna ) Avian acute toxicity — 8,700 mg/kg ! (Japanese quail) Avian acute toxicity — 20,000 mg/kgV (mallard duck) Avian 8—day dietary toxicity — greater than 10,000 ppm.?./ (mallard duck) Avian 8—day dietary toxicity — greater than 10,000 ppm.?! (bobwhite quail) .1/ No more than moderately toxic to aquatic invertebrates. V Practically nontoxic to birds. ------- —5— Avian dietary toxicity — greater than 14,000 pp&I (bobwhite quail) Avian subacute toxicity — greater than 30 ppmV (bobwhite quail) 96-hour acute fish toxicity. ./ bluegill — greater than 100 ppm rainbow trout — 72 (147—110) ppm goldfish — 350 (312—392) ppm guppy — 150 (113—200) ppm catfish - less than 500 ppm but greater than 200 ppm Tolerance assessment List of crops and tolerances (110 CFR 180.317): Comrnodity Tolerance (ppm) Alfalfa, fresh 10.0 Alfalfa, forage 10.0 Alfalfa, hay 10.0 Apples 0.1 Artichokes 0.1 Blackberries 0.05 Blueberries 0.05 Boysenberries 0.05 Cattle, fat 0.02 Cattle, kidney 0.2 Cattle, liver 0.2 Cattle, Meat Byproducts (MBYP)(exc. kidney and liver) 0.02 Cattle, meat 0.02 Cherries 0.1 Clover 5.0 Crown vetch 5.0 Eggs 0.02 Endive (escarole) 2.0 Goats, fat 0.02 Goats, kidney 0.2 Goats, liver 0.2 Goats, MBYP (exc. kidney and liver) 0.02 I’ Practically nontoxic to birds. V 300 ppm was highest dose tested: no deaths occurred, therefore, no toxicity level could be determined. . ./ Practically nontoxic to warmwater fish; slightly toxic to coldwater fish. ------- —6— Commodity Tolerance (ppm ) Goats, meat 0.02 Grapes 0.1 Hogs, fat 0.02 Hogs, kidney 0.2 Hogs, liver 0.2 Hogs, MBYP (exc. kidney and liver) 0.02 Hogs, meat 0.02 Horses, fat 0.02 Horses, kidney 0.2 Horses, liver 0.2 Horses, MBYP (exc. kidney and liver) 0.02 Horses, meat 0.02 Lettuce 1.0 Milk 0.02 Nectarines 0.1 Peaches 0.1 Pears 0.1 Plume 0.1 Poultry, fat 0.02 Poultry, kidney 0.2 Poultry, liver 0.2 Poultry, MBYP (exc. kidney and liver) 0.02 Poultry, meat 0.02 Raspberries 0.05 Sainfoin 5.0 Sheep, fat 0.02 Sheep, kidney 0.2 Sheep, liver 0.2 Sheep, MBYP (exc. kidney and liver) 0.02 Sheep, meat 0.02 Trefoil 5.0 Results of tolerance assessment The provisional acceptable daily intake (PADI) for pronamide was based on the NOEL of 7.50 mg/kg in the 2—year dog study. It should be noted that this PADI is based on systemic toxicity (nononcogenic). The current PADI Is 0.0750 mg/kg/day and the current published tolerance for pronarnide has a calculated Total Maximum Residue Concentration (TM1 C) of 0.01109 mg/day (1.5 kg diet). The percentage of PADI utilized is 0.91%. ------- —7— I L SUMMARY OF REGULATORY POSITION AND RATIONALE Use classification: Wettable powder end—use products are being classified as restricted—use pesticides. Wettable powder formulations of pronamide pose risks, through dermal exposure, to mixers and applicators which can be reduced to an acceptable level by requir- ing that pronamide only be applied by certified applicators. Unique label warning statements Manufacturing Use Products: “CAUTION — Harmful if absorbed through the skin or inhaled. Causes moderate eye irritation. Avoid contact with the skin, eyes, or clothing. Avoid breathing dust. Wash thoroughly with soap and water after handling. Remove contaminated clothing and wash before reuse.” “Do not discharge effluent containing this product into lakes, streams, ponds, estuaries. 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 treat- ment plant authority. For guidance contact your State Water Board or Regional Office of the EPA.” All End—Use Products “GENERAL PRECAUTIONS: Avoid contact with eyes, skin or clothing.” “PROTECTIVE CLOTHING: When mixing, loading or applying this product, wear mldforearm waterproof gloves, long-sleeved shirts and long pants, preferably one piece (coveralls). Hand-spray or hand—spreaders also require the use of waterproof boots or shoe coverings. Wash non— disposable gloves, boots and shoe coverings thoroughly with soap and water before removing.” “If water—soluble packaging is used, mixers and loaders are exempted from protective clothing requirements.” ------- -8- “Protective clothing/equipment is not needed during application if an enclosed tractor cab with filtered air supply or enclosed cockpit is used.” “Any article of clothing worn while handling product must be cleaned before reusing. Clothing should be laundered separately from household articles. Cloth- ing which has been drenched or heavily contaminated should be disposed of in accordance with state or local regulations.” “Do not apply directly to water. Do not contaminate water by cleaning of equipment or disposal of wastes.” “Crops other than those on which pronamide may be applied may not be planted in pronamide-treated soil.” “Hand-spray applications of pronamide can be made only to ornainentals and nursery stock.” All % ettable Powder End-Use Products. These products must be packaged in water-soluble packaging and bear the following statements: “RESTRICTED USE PESTICIDE: Because pronamide has produced tumors in laboratory animals, this product is for retail sale to and use only by Certified Applicators or persons under their direct super- vision, and only for those uses covered by the Certified Applicator’s certification.” “Dilution Instructions” “The enclosed pouches of this product are water soluble. Do not allow pouches to become wet before adding them to the spray tank. Do not handle the pouches with wet hands or gloves. Always reseal overwrap bag to protect remaining unused pouches. Do not remove water soluble pouches from overwrap except to add directly to the spray tank.” “Add the required number of unopened pouches as determined by the dosage recommendations into the spray tank with agitation. Depending on the water temperature and the degree of agitation, the pouches should dissolve completely within approximately five minutes from the time they are added to the water.” All Granular End-Use Products “Site treated with this product must be thoroughly watered after application.” ------- —9— 5. SUMMARY OF MAJOR DATA GAPS Data required: Due date (or after issuance of Standard):- Toxicology: Chronic toxicity (rodent) 50 months Oncogenicity (rat) 50 months Teratogenicity (rat) 15 months Reproduction (rat) 39 months Mutagenicity - gene mutation 9 months Mutagenicity — structural 12 months chromosommal aberration Mutagenicity — other 12 months genotoxic effects Special testing — general 2 I months metabolism Special testing — dermal 12 months penetration Environmental fate 9-39 months Residue Chemistry January 1988 6. CONTACT PERSON AT EPA Robert J. Taylor U.S. Environmental Protection Agency TS—767C 401 M Street SW. Washington, DC 20460 (703) 557—1800 DISCLAIMER: The information presented in this Pesticide Pact Sheet is for informational purposes only and may not be used to fulfill data requirements for pesticide registration and reregistration. ------- |