EnmrorwiMnlal Protwa.cn OH** 0( Pvt«cMt« Program (TS-766C) Washington. DC 2O460 v>EPA Pesticide Fact Sheet Name of Chemical: NABA;I Reason for Issuance: KI:CIS>|IHA-!ION SIAMVHI Date Issued: APRIL> 1987 Fact Sheet Number: 124 DESCRIPTION OF CHEMICAL Generic Name: Disodium ethylene bisdithiocarbamate Common Name: Nabam Trade Names: Chem Barn*; Dithane* D-14; Dithane* A-40; DSE»; Nabasan*; Parzate*; Spring Bak*. EPA Shaughnessy Code: 014503 Chemical Abstracts Service (CAS) Number: 142-59-6 Pesticide Type: Fungicide Chemical Family: Ethylene bisdithiocarbamate (EBDC) U. S. and Foreign Producers: Alco Chemical Corporation; Vinnings Chemical Company; Rohm and Haas USE PATTERNS AND FORMULATIONS Registered Uses: Industrial sites (cooling towers, evaporative condensers, air washer systems, secondary oil recovery water and drilling fluids, pulp and paper mills, cane sugar mills, beet sugar mills). All registered food (except £01 u»e in sugar mill flume water) and ornamental uses of nabam, a total of 35, are currently suspended. t Major Uses: Domestic usage of nabam as a pesticide (Typical current year basis (1983-1985)): t Sector IDS, x 1,000 Percent Cooling Water 475 40 Sugar 425 37 Paper 275 23 Totals 1175 100 Formulation Types Registered: Ready-to-use 3.75 to 22% nabam, Formulation Intermediates - 22.5 to 30% nabam, and Soluble Concentrates - 22% or 93% nabam. ------- —2— Methods of Application: In most industrial uses, nabam is added directly to water either by a single dose or continuous feed. Application Rates: Rates range from .09 to 3.0 parts per million (ppm) in sugar processing; 30 to 120 ppm in pulp and paper processing; 2.6 to 60 ppm in water cooling towers. General industrial preservative uses are in the range of 30 to 120 ppm. Usual Carrier: Water SCIENCE FINDINGS Summary Science Statement : A major toxicological concern from exposure to nabam is the hazard to the human thyroid from presence of ethylenethiourea (ETIJ), a contaminant, degradation product, and metabolite present in nabam and other EBDC fungi- cides. Additional chronic studies on riabarn are required for further evaluation. Moreover, ETU has caused developmentally toxic/teratogenic effects in rats and hamsters. There are no adequate teratology studies on nabam. Teratology studies with nabam are required before its teratogenicity can be fully assessed. ETU has been classified as a Group B2 carcinogen in accordance with the Agency’s Guidelines for Carcinogen Risk Assessment (September 26, 1986, 51 CFR 33992), based on studies which show that it induced an increased incidence of thyroid adenomas and adenocarciriomas in rats and hepatomas in mice. Because of the presence of ETU in nabam, the Agency is considering whether further regulatory considerations are warranted. Available data are not adequate to assess the environmental fate of riabam. However, etudieB do indicate that ETU, the major degradate of nabam, has leaching potential in certain soil types. A complete assessment of the environmental fate, including the potential for groundwater contamination, from the use of nabam products will be undertaken when data are available. Available data are insufficient to completely evaluate the ecological effects of nabam. Based on available data, nabam is moderately toxic to freshwater fish; moderately to highly toxic to certain estuarine organisms. ------- —3— Physical/Chemical Characteristics : Physical state: Liquid at 25° C Empirical Formula: C 4 H 6 N 2 Na 2 S 4 Molecular weight: 256.3 Toxicology Charateristics : Major Route of Exposure: Dermal Acute Toxicity: Oral Toxicity: Toxicity category II Dermal Sensitization: Skin sensitizer Mutagenicity: Additional studies required Negative — Host—mediated assay in mice in Salmonella typhimuriuin. Positive — Sister-chromatid exchanges in CHO cells Negative — In Vivo bone marrow cytogenetic assay Physiological and Behavioral Characteristics Mechanism of Pesticidal Action: Nabain inhibits enzyme activity by complexing with metal—containing enzymes including those involved with the production of adenosine triphosphate (ATP). Metabolism: Nabam appears to be rapidly absorbed from the gastrointestinal tract, distributed to target organs and excreted almost totally within 96 hours. Environmental Characteristics: Photodecomposition and/or Volatility: Studies required Hydrolysis: Studies required Anaerobic Aquatic Metabolism: Studies required Leaching and adsorption/desorption studies: Nabam is slightly mobile in certain soil types. Additional studies required. Ecological Characteristics: Freshwater Fish Toxicity: Moderately toxic. Studies required. Effects on Non—target Insects: Relatively nontoxic to honey bees. ------- —4— Tolerance Assessment There are no established tolerances for residues of nabam se on any food or feed items. All food crop uses of nabam are rrently suspended. When used on food crops nabam is tank mixed with zinc sulfate leading to the formation of zineb. Nabam is not mixed with zinc sulfate when used on onions to control smut. Therefore, for this use registrants are required to submit residue data on nabam. For the other food crop uses, application actually consists of a solution of zineb instead of nabam. Therefore, residues in agricultural commodities treated with nabam are expected to be zineb. The use of nabam as an industrial biocide to treat flume water in sugar beet mills is considered to be a treatment of a raw agricultural commodity. Regulations have been established by the Food and Drug Administration under 21 CFR 173.320(b)(3) for nabam residues following application to sugar mill grinding, crusher and/or diffuser systems. The treatment of flume water, transporting and washing systems are under EPA’s jurisdiction. Residue data are required in this Standard to determine if the residues concentrate in any of the processed sugar commodi- ties. SUMMARY OF REGULATORY POSITION AND RATIONALE EPA is currently evaluating the potential human health risks resulting from the food, field and food crops and terrestrial non—food uses of nabam to determine whether additional regulatory action is warranted on nabam and the other EBDC pesticides containing the common contaminant, degradation product, and metabolite, ETU. ETU is mutagenic, oncogenic and teratogenic, and the Agency has classified it as a Group B2 oncogen (Probable Human Carcinogen). After considering exposure to ETU from the industrial, non-food uses of nabam, the Agency has concluded that the risks from exposure to ETU from use of nabam are not a concern for most industrial uses at this time because applicator exposure, based on available information, appears negligible. The Agency lacks data to assess exposure to nabam from the metalworking fluid and tanning uses. Additional information is being required for all industrial uses. The Agency does not believe that further regulatory action on nabam products registered for industrial non-food uses is warranted at this time. The Agency will not consider any new food use tolerances for nabam at this time. The Agency will consider the need for establishment of tolerances for ETU and any intermediate metabolitea when data are sufficient to permit such decisions. While data gaps are being filled, currently registered manu- facturing—use products (MP’s) and end-use products (EP’s) containing nabam as the sole active ingredient may be sold ------- —5— distributed, formulated, and used, subject to the terms and conditions of the naham recjistration standard. Mowever, significant new uses will not be registered. Registrants must provide or agree to develop and provide additional data in order to maintain existing registrations. The Agency has determined that all, data will be immediatel.v reviewed as they are submitted. Precautionary Statements Required on Labels: Manufacturing—Use Products “This pesticide is toxic to fish. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water unless this oroduct is specifically identified and addressed in an NPDFS nermit. Pb not discharge effluent containing this nroduct to sewer systems without previously notifying the sewage treatment plant authority. For auidance, con- tact your State Water Roard or Pegional Office of the EPP.” End—Use Products gricultural Tise Products “This nesticide is toxic to fish. flrift and runoff from treated areas may he hazardous to acuatic organ- isms in neighboring areas. Do not anplv directl.v to water or wetlands (swamps, hogs, marshes, and notholes). P0 not contaminate water by cleaning of equipment or disposal of wastes.” All Home Use Products “PWOTFC’rIV M ’kSflR S: Always spray with your hack to the wind. Wear long—sleeve shirt, long nants, and rubber gloves. Wash gloves thoroughly with soap and water before removing, Change your clothes immediately after using this product and launder separately from other laundry items before reuse. Shower immediately after use.” Home Use Products with rood rises “Preharvest intervals on this label are specified so that nesticide residues will he at an acceptable level when the cron Is harvested.” All Aaricultural Products “After (snravs have dried/dusts have settled/vanors have dispersed, as applicable) do not enter or allow ------- —6— entry into treated areas until the 7 4 —hour reentry interval has expired unless wearing the nersonal protective eguinment listed on the label.”. “ WORKER SAFETY RULES J(een all unprotected nersons, children, livestock, and pets away from treated area or where there is danger of drift. “no not rub eves or mouth with hands, See First Aid (Practical Treatment Section).” “ PERSONAL PROTECTIVE EOUIPMENT HANDLERS (MIXERS, LOADERS, AMP APPLICATORS) AND EARLV REENTRV WORKERS MUST WEAR THE FOLLOWING PROTECTIVF CLOTHING ANP EOUIPMENT: a long—sleeve shirt and long Dants or a coverall that covers all parts of the body except the head, hands, and feet; chemical resistant gloves; shoes, socks, and goggles or a face shield. During mixing and loading, a chemical resistant apron must also be worn. During annlication from a tractor with a completely enclosed cab with positive nressure filtration, or aerially with an enclosed cocknit, a long—sleeve shirt and long pants may he worn in place of the above nrotective clothing. Chemical resistant gloves must he available in the cab or cockpit and worn while exiting. IMPORTANT! Refore removing gloves, wash them with soan and water. Always wash hands, face, and arms with soap and water before eating, smoking or drinking. Always wash hands and arms with soan and water before using the toilet. After work take off all clothes and shoes. Shower using soap and water. Wear only clean clothes. Do not use contaminated clothing. Wash protective clothing and protective equipment with soap and water after each use. Personal clothing worn during use must be laundered separately from household articles. Clothing and protective equipment heavily contaminated or drenched with naham must be destroyed according to state and local regulations. HEAVILY CONTAMINATED OR DRENCHED CLOTHING CANNOT RE ADF.OUATELV DECONTAMINATED. During aerial application, human ftaggers are nrohibited unless in totally enclosed vehicles.” ------- —7— Industria 1 rise Products “This nesticirle is toxic to fish. Snil.ls, snravs, and runoff From use site may he hazardous to aquatic organ- isms in neighboring areas. fl not apply rlirectlv to water or wetlands (swarnos, hogs, marshes, and notholes i. no not contaminate water by cleaning of equipment or disposal of wastes.” “HANDLE (rN LunIMG MIXING, LOAfING, OR APPLYING) ‘ HIS PRO )UC’ ONLY WHEN WEARING THE FOLLOWING PROTECTIVE CLOTHING AMP FOUIDMFP’IT: A long—sleeve shirt and long nants or a coverall that covers all parts of the body except the head, hands, and feet: chemical resistant gloves; and goggles or a face shield. flurinq mixing and loading, a chemical resistant apron must also be worn.” SUMMARY OF MAJOR DATA GAPS Product Chevnjstrv — All Residue Chemistry — Plant and animal metabolism Residue studies Toxicology — Acute dermal. and inhalation toxicity Primary eye and dermal irritation 21—day suhchronic derrnaI Chronic toxicity (rodent and nonrodent) (food uses) flncoqenicitv (rat and rnouse)(Food uses) Teratology (rabbit and rat) Peproductjon (rat) Mutacienicity (gene mutation, cell transformation, unscheduled DNA synthesis) Percutaneous dermal absorption Ecological Effects — Avian oral toxicity Avian dietary toxicity Freshwater fish toxicity Freshwater invertebrate toxicity Estuarine and marine organism toxicity Aquatic organism accumulation Simulated or actual field testing—aquatic organisms Nontarget area phytotoxicity—aquatic plant growth Environmental Fate — Hydrolysis Photodegradatlon (water, soil) Aerobic and anaerobic soil metabolism Aerobic and anaerobic aquatic metabolism Leaching and adsorntion/desorntiOn ------- —8— Volatility (laboratory) Field dissipation (terrestrial,aquatic) Rotational crops (confined) Fish accumulation Reentry — Reentry protection studies - Ethylenethiourea (ETU ) — Toxicology — Chronic (rodent and nonrodent) Reproduction Dermal (percutaneous) absorption Mutagenicity (promotion) Environmental Fate - Hydrolysis Photodegradation (soil and water) Aerobic and anaerobic soil metabolism Leaching and adaorption/desorption Degradation (soil) CONTACT PERSON AT EPA Ms. Lois Rossi Acting Product Manager (Team 2’) Fungicide-Herbicide Branch Registration Division (TS767C) Office of Pesticide Programs, EPA Washington, D.C. 20460 Telephone: 703—557—1900 DISCLAIMER : The information presented in this Pesticide Fact Sheet is for Information purposes only and may not be used to fulfil data requirements for pesticide registration and reregis- tration. ------- |