United Sutai o«ic» of P*nieid« and TOKIC Sutatincw Invironmannl Prottawn Qtl.w of Pwiadi Prognmt (TS-766CI Agency Mtohington. DC 20460 Pesticide Fact Sheet Name of Chemical: , , , A, J—1 Reason for Issuance: Registration Standard Date Issued: September 1986 Fact Sheet Number: 95 1. Description of the chemical Generic name: 1,3-dichloropropene (C3H4C12) Oonncn name: None Trade names: Telone II«, Dow Telone®, Chemical Abstracts Service (CAS) Registry Number: 542-75-6 Office of Pesticides Program Number: 029001 Year of initial registration: 1966 Pesticide type: Broad spectrum soil fumigant Chemical family: Chlorinated hydrocarbon U.S. producer: Dow Chemical Ctnpany 2. Use patterns and formulations; Application sites: A soil fumigant with nematicidal, fungicidal, insecticidal and herbicidal properties, for use on cotton, potatoes, tobacco, sugar beets, vegetables, grains, citrus fruit tree planting sites, deciduous fruit and nut-tree planting sites, bush and vine planting sites, floral/turf and ornamental tree sites. Types of formulations: 94% liquid concentrate formulations. Types and methods of applications: Chisel injection into the soil, using row (banded) or overall (broadcast) treatment. Application rates: 43 to 968 Ibs ai/acre. One application per year. Usual carriers: None ------- —2— 3. Science F1nd1ri Science s mnary : The Agency has categorized 1 ,3-dlchloropropene as a probable human carcinogen. Chronic toxicity data show that the ch nical Is oncogenic at multiple sites In both sexes or rats arxl mice. Other data supporting the oncogenic finding of 1, 3-dIchloroprope e are: (1) a subcutaneous ir,.j ection study In mice which showed Increased incidence of flbroearcanas at the site of Injection, (2) studies showing that the cal3pound Is a direct acting mutagen, and (3) the structural similarity between 1,3-dlchloropropene and 1o owi human oncogens (I.e. vinyl chloride). The ch nical has not been shown to cause teratogenic effects in rats or rabbits. 1, 3—dichioropropene is acutely toxic by the oral and lnhalatlcn c te! of exposure. 1,3—dichioropropene has low to moderate toxicity to birds and moderate toxicity to fish and aq tic Invertebrates. Limited data indicate that 1,3-dichioropropene has the potential to leach ground water in sensitive erivirorments. Available data are insufficient to more canpletely assess the envirorinental fate of the pesticide. Available data are also insufficient to assess the residues in raw agricultural canim dities. 1,2—Dichioropropane, an Impurity In 1,3-dlchioropropene, Is oncogenic in rats and mice. However, Its oncogenic potency is lower than for 1,3—dichioropropene. t ta indicate that 1,2-dichloropropane has the potential to leach to ground water. Ch nIcal characteristics : Color: Pale yellow liquid at roan t nperature. ! b1ecular eIgbt: 110.98. Miscible in hydrocarbon solvents. Toxicological Characteristics : Acute oral toxicity — i170 to 713 mgJkg, Toxicity Category II Acute oral toxicity — 6Z 0 mg/kg, Toxicity Category III, Skin irritation — Moderate irritant, Toxicity Category III Eye irritation — Corneal opacity reversible within seven days, Toxicity Category II. Subchronlc toxicity Subchronic inhalation (rat and mouse) - NOEl, 30 ppii ------- —3— Chronic toxicity . A two-year rat oral gavage study had a NOEL of 25 mg/kg/day. Effects noted were an increased incidence of basal hyperplasia in treated males ard f nales, increased kidney nephropathy in treated f ru 1 es, and urinary bladder edana at high dosages In males and fanales. In a two year mouse feeding study, the effects noted were reduced fenale survival rate at the high dose and increased incidences of urinary bladder epithelial cell hyperplasla in both males and fariales in the mid-and high-dose levels. A NOEL was not determined in this 8tUdy. C icogenIcity : I ,3-dichloropropene has been classified as a probable hunan c .rcInogen based on studies In rats and mice. Oral studies in rats showed that it produced squamous cell papillanas and carcinanas of the forestanach in males at the high dose. In the liver, there were increases of neoplastic nodules In treated males at both dosage levels canpared to the controls. In fanale rats, squamous cell papi1lc ’ras of the f’orestcinach, marrunary gland adenanas/flbroadenanas and thyroid follicular cell adenanas/ carcincsnas were observed. In mice, 1 ,3-dichloroproperie produced an increased incidence of urinary bladder transitional cell carcincinas, squamous cell papillcznas of the forestanach, and lung adencr as and carcincinas (ccznbined) in f’enales at the mid and high dosage levels. There was an increase In hepatocellular adenanas and carcinanas in the fenales at the mid dosage level. In male mice, there was an increased incidence of hepatocellular adenanas In canbinatlon with carcincinas, lung adenanas In canbination with carcinaras, and squamous cell papillcxnas of the forestanach at the mid and high dosage levels. Urinary bladder carcinanas were also observed in the male8 at the high dosage level. Studies also indicate that 1,2-dichioropropane, an Impurity in 1,3- dichloropropene, Is an oncogen In rats and mice, but the Agency believes it i a less potent oncogen than 1,3-dichoropropene. Mutagen.lcity : 1, 3-dichioropropene has been determined to be a direct acting mutagen. 1,3—dichloropropene has produced positive gene mutation in microbial aystans. In addition, 1,3-dichioropropene produced positive results for DNIt damage/repair in microbial strains. I ta on structural chranoscinal aberration are not available. These studies are required. Reproductive effects : ! data are available on reproductive effects. A two-generation reproduction study Is required. Develoixnental effects : In two inhalation studies, 1,3-dichioropropene was found to cause develoj nental effects In rats and rabbits. In the rat study, no teratogenic effects’ were observed, but maternal toxicity occurred at all dose levels. Developnental toxicity (delayed ossifi- cation of vertebral centra) occurred at the highest dose (120 ppn). In the rabbit study maternal toxicity occurred at the 2 highest dose levels (60 ppn and 120 ppn), but no evidence of developnental toxicity was apparent. ------- Exposure : The average inhalation exposure of applicators engaged in various work activities Is estimated to range fran 0.15 to 23.99 mg/kg/year. Dietary exposure to 1 ,3-dichloropropene has not been estimated. Residue data for this assessment are required. Risks to workers and applicators : The upper bound Inhalation oncogenic risks to workers handling 1,3-dichioropropene during distribution and storage are estimated to be in the range of 10—2 to 10-5. Risks to applicators during and immediately post-treath ent are estimated to be in the range of io3 to io5. Physiological and biochemical behavioral characteristics : Mechanism of’ pesticidal action: 1,3—dichioropropene acts as a sterilant on contact with the pest. Metabolism in plants : Metabolism of 1 ,3-dichloropropene in plants is not adequately understood. Envirorinental characteristics : t ta indicate that 1 ,2-dichloropropane, an impurity of’ technical 1,3-dichioropropene has the potential to leach to ground water. Additional studies on the env1roi ental fate of 1,3-dichioropropene, its Impurities and metabolites are required. 1 ta indicate that 1,3-dichioropropene itself leaches to ground water ,then it Is present in the most sensitive envlrornent (shallow ground water and sandy soils of low percentage organic matter in areas of high rainfall or irrigation). Ecological characteristics : Avian acute oral toxicity: Bobwhite quail - 152 mg/kg Avian dietary toxicity: Mallard duck — >10,000 ppn Bobwhite quail - >10,000 ppn Aquatic invertebrate toxicity: t phriia magna — 6.2 ppn Freshwater fish toxicity: Bluegill sunfish — 7.09 ppn Rainbow trout — 3.9z1 ppn sed on these data, the Agency characterizes 1, 3-dichloropropene as low to moderately toxic to waterfowl and upland game birds. 1,3-dichioro- propene Is moderately toxic to coidwater fish, warmwater fish, and freshwater invertebrates. Endangered species : 1,3-dichioropropene has low to moderate toxicity to birds and aquatic species. Available data do not Indicate a potential hazard to endangered species. Tolerance assessment : No tolerances or exemptions fran the requirement of tolerances for residues of’ 1,3—dichioropropene in or on food/feed casnodities have been established in the United States, Mexico, Canada or by the Codex Al 1n ntarius. ------- -5- Current data are inadequate to determine if residues of 1 ,3-dlchloropropene, its matabolites, or manufacturing impurities will result in food or feed fran use of 1 ,3-dichloropropene. 1 ta on the metabollmii of 1 ,3—dichloropropene in crops grown In treated soils are required. The additional data will be used to assess possible residues in food and feed crops and may lead to additional data requir iients In residue ch nistry. !I lerances in food crops may be necessary If residues are found In crops, and may be necessary In an1inaL if’ residues are found In animal feed 1t iis. Reported pesticide incidents : The Agency’s Pesticide Incidence Monitoring Systen does not report any Incidents during the perIod 1966—1981. However, information fran the State of’ California indicates that physicians treated an average of 2.20 1,3-dichloropropene incidents annually fran 1981 through 1985. An additional 3.80 occupational cases were reported annually as de rma.l (1.80) or eye (2.00) Injuries. LI. S mTn ry of regulatory positions and rationale : The Agency has placed 1,3-dlchloropropene in Special Review because of oncogenic effects • 1, 3-dlchloropropene has been categorized as a probable human carcinogen, with effects d ronstrated at multiple sites in both sexes of rats and mice. The Agency Is classifying the 1,3—dichloropropene products for Restricted Use by certified applicators only, based upon acute toxicity and onccgenicity. Restricted use will help ensure that mixer/loaders and applicators observe use precautions intended to protect a inst inhalation exposure. The Agency is continuing on an Interim basis the current reentry Interval of 72 hours for 1,3—dichioropropene products. The Agency is continuing to require protective clothing and equ1 nent during mixing, loading, application, and If spillage occurs. Protective clothing and equip ent include coveralls, gloves, heavy-duty footwear, safety goggles, and a mask or respirator approved for use with 1,3— dichioropropene. —— Available residue data are inadequate to determine if’ residues of 1 ,3—dlchloropropene, Its metabolites, or manufacturing Impurities will occur In food or feed as a result of soil ftznigatlon. Although such fizn1 tIori use has in the past been considered non-food, the Agency may require the establis nent of tolerances in food, feed, or animals If residues are found. The Agency is requiring enviromental fate data including ground ter nonitoring studies on 1,3—dichloropropene, its impurities, and metabolites to determine whether there Is a potential for groundvater contamination. ------- —6— —- The Agency will require a cancer hazard warning statement on 1, 3-dichloropropene products, to provide the opportunity for informed consent by users, and to encourage canpilance with protective measures that will reduce exposure. E dangered species labeling statements are not warranted at this tune, based upon available data. Il ’ envirormental fate or other data indicate a potential hazard to endangered species, the Agency will request a consultation Iran the Office of F idangered Species, t parthient of the Interior. 5. La lir,Z tater1ents . a. Manufacturing-Use Products Precautionary Statements: “DANGER. Causes severe eye damage. May be fatal if inhaled, absorbed throu skin, or swallowed. Do not get in eyes, on skin or on clothing. Wear chemical worker goggles, face shield or safety glasses. Wash tIx)roughly with soap and water after handling, and before eating and amoking”. Effluent discharge statement: “Do not discharge effluent containing this product directly into lakes, streams, ponds, estuaries, oceans or public waters unless this product is specifically identified and addressed In a National Pollutant Discharge Elimination System (NPDES) permit. Do not discharge effluent containing this product into sewer systems without previously notifying the sewage trea nent plant autbority. Pbr guidance, contact your State Water Board or Regional Office of the Dwirorinental Protection Agency”. Cancer Hazard Warning Statement: “ The use of this product may be hazardous to your health. This product contains 1 ,3-dichloropropene • which has been determined to cause ttmrs In laboratory animals. Risks can be reduced by closely following the use directions and precautions, and by wearing protective clothing specified elsewhere on this label”. b. & d Use Products . Precautionary statements: “DANGER. Causes severe eye damage. May be fatal If inhaled, absorbed throu skin, or swallowed. Do not get in eyes, on skin or on clothing. Wear chemical worker goggles, face shield or safety glasses. Wash thoroughly with soap and water after handling, and before eating and amoking.” Restricted use statement: “Por retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator’s certification.” ------- —7— Cancer Hazard Warning Statement: “ The use of this product ma.y be hazardous to your health. This product contains 1,3-dichioropropene which has been deter nined to cause t ziors in laboratory animals. Risks can be reduced by closely following the use directions and precautions, and by bearing protective clothing and equipnent specified elsewhere on this label.” E ivircn ntal hazard statement: “I not contaminate water by cleaning of equipnent or disposal of wastes. In case of spills, properly dispose of contaminated materials.” Protective clothing statements: “Required clothing and equipnent for mixing/loading and applying 1., 3-dichioropropene”: “ e—piece coveralls which have long sleeves and long pants constructed of laminated fabric as specified in the USDA/EPA Guide for Camerclal Applicators”. “Liquid-proof hat such as a plastic hard hat with a plastic sweat band”. “Heavy-duty liquid proof (neoprene/synthetic) work gloves and boots”. “Any article worn while handling 1 ,3-dichloropropene must be washed before reusing. Imedlately remove all clothing which has been drenched or has otherwise absorbed 1 ,3-dichloropropene Iran any spill. Dispose of contaminated clothing in a sanitary landfill, or by incineration if allowed by state and local authorities. If burned, stay out of smoke.” Reentry statement: “Workers entering the treated area for 72 hours after application of l,3—dichloropropene nn.ist ar protective clothing.” Storage And Disposal Statements: “Pesticide wastes are hazardous. Improper disposal of excess pesticide is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or E viromental Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for Guidance.” 5. Swinary of major data gaps : Residue chemistry data Nature of residue (plant metabolian) May 30, 1987 Storage stability May 30, 1987 Crop field Trials April 30, 1988. ¶Ibxicology data Acute dermal toxicity June 30, 1987 Acute inhalation toxicity June 30, 1987 Dennal sensitization June 30, 1987 ------- —8- 21 day dermal Chronic toxicity - dog cogenicity - rat and mouse Reproduction Structural chrcinoscinal aberration General metaboliam Envirornental fate data Photodegradation in air Aerobic soil metaboliam Anaerobic aquatic metabolism Aerobic aquatic metabollam Mobility of degradates (leaching, adsorption/desorptlon) Soil dissipation Aquatic sediment Soil dissipation (long-term) Accunulatlon in rotational crops (confined) Monitoring ground water & well water (protocol) Reentry protection data Soil dissipation t rmal exposure Inhalation exposure October 30, 1987 I c nber 30, 1990 July 30, 1988 July 30 1987 October 30, October 30, June 30, 1987 January 30, 1989 January 3C, 1999 Janaury 30, 1989 October 30, 1987 January 30, 1989 January 30, 1989 I ceiiber 30, 1990 January 30, 1990 April 30, 1988. Ecological effects data are not required for this Standard. Product chenistry data are required durIng 1987. 6. Contact Person at EPA : Lois Rossi, Office of Pesticide Programs, EPA, Registration Division (TS-767C) Fungicide—Herbicide Branch 1 M Street., S.W. Washington, DC 20 l60. Ptx ne (703) 557—1900 DISCLAIMER: The information presented in this Chanical Information Fact ieet is for Informational purposes only and may not be used to fulfill data requiranents for pesticide registration and reregistration. 1987 1988 January January January 30, 1989 30, 1989 30, 1989 ------- |