Untt«J Stftm Offic* of Pvttekta and Toxic Emironimntal Protection Offic* of PtMtddt Programs (TS-766C) Agency Wadiington. DC 20460 vvEPA Pesticide Fact Sheet Name of Chemical: Reason for Issuance: Date Issued: Septanber 30, 1983 Fact Sheet Number: n 1. DESCRIPTION Or CHEMICAL Generic Name: N,N-dimethyl-N'-(3-[I(methylamino)carbonyl) oxyjphenyl] methanimidamide nonohydrochloride Common Name: Pormetanate hydrochloride(HCl) Trade Name: Carzol EPA Shaughnessy Code: 097301 Chemical Abstracts Service (CAS) Number: 23422-53-9 Year of Initial Registration: 1969 Pesticide Type: Acaricide/Insecticide Chemical Family: methylcarbamate hydrochloride U.S. and Foreign Producers: Imported into the U.S. from West Germany where it is manufactured by Schering A.G. Chemical Company. In the U.S., the sole importer and distributor of the chemical is Nor-Am Chemical Company. 2. USE PATTERNS AND FORMULATIONS Application Sites: Citrus, pc*e and stone fruits and alfalfa grown-for-seed. Types of Formulations: 92% soluble powder Types of Methods of Application: Ground and aerial Application Rates: Range from 0.0575 Ibs. a.i./A to 1.38 Ibs. a. i./A Usual Carriers: Hater ------- 3. SCIENCE FINDINGS Su ary Science Statement Formetanate D cl is highly toxic from an oral route of exposure. It demonstrates low toxicity from the dermal route of exposure and moderate toxicity from the inhalation route of exposure. it is considered to be an eye irritant. The chronic studies ar ’s data gaps. Formetanate HC1 appears to leach in soil and therefore has a potential for contamination of groundwater. However, avail- able data are insufficient to fully assess the environmental fate of this chemical. A 24—hour reentry interval has been established. This chemical is highly toxic to birds. It is slightly toxic to fish and moderately toxic to estuarine and marine organisms. A tolerance reassessment cannot be made until the studies re- quired to fill the toxicology data gaps have been submitted and validated. A petition for a tolerance for residues in or on alfalfa hay and alfalfa forage must be submitted. A food additive petition must be submitted for apple pomace. Chemical Characteristics Physical State: Crystalline solid Color: White Odor: Essentially odorless Nelting point: 200—202 C Toxicology Char çteristice Acute Oral LD 50 : 26.4 ag/kg (rat), Toxicity Category I Acute Dermal LD 50 : > 10,000 mg/kg (rabbit), Toxicity Category 111 Primary Dermal Irritation: No irritation (rabbit), Toxicity Category IV Primary Eye Irritation: One—fifth of the animals (rabbit) showed irritation at a 7—day observation period. The effect was considered to be presumptively not reversible in 21 days. Acute Inhalation LC : 0.29 mg/liter (rat), Toxicity Category II The chronic studies are data gaps. The original studies were conducted by IBT and have been determined to be in- valid. No replacement studies have been submitted. A ------- 3 commitment has been made by Nor-Am Chemical Company to replace the IBT studies. A risk assessment cannot be completed at this time due to gaps in the data base. Physiological and Biochemical Behavioral Ctraracteristjcs Mechanism of Pesticidal Action: A contact insecticide which causes reversible carbamylation of the acetylcholinesterage enzyme. Poisoning also impairs the central nervous system function. Metabolism and Persistence in Plants and Animals: In plants, formetanate HC1 is absorbed into the leaves but is not translocated to untreated areas. On the fruit, weathering and growth dilution appear to be the primary cause of the dissipation of formetanate Rd. In animals, formetanate is eliminated in the urine and feces. The major metabolic pathway involves hydrolysis to metabolites and subsequent formation of the glucuronide and ethereal sulfate con)ugates of m—acetamidophenol. Environmental Characteristics Available data are insufficient to fully assess the environ- mental fate of formetanate Rd. It appears to rapidly degrade in soil under aerobic conditions. This chemical appears to leach in soil and, therefore has a potential for groundwater contamination. A 24—hour reentry interval has been established for this chemical on orchard crops. Ecological Characteristics Avian oral LD 50 - Mallard duck: 11.7 mg/kg Bobwhite quail: 43.1 mg/kg The avian dietary LC 50 studies, freshwater fish LC 50 studies and acute LCso freshwater invertebrate studies are data gaps. Formetanate HC1 is characterized as highly toxic to birds. It is slightly toxic to warawater fish and moderately toxic to eatuarine and marine organisms. It is moderately toxic ------- 4 to honey bees with direct contact spray, but it has very low toxicity to bees when they are exposed to residues on plants. Tolerance Assessments A full tolerance reassessment cannot be completed because of certain residue chemistry and toxicology data gaps. The current values for the acceptable daily intake intake(ADI) of 0.025 mg/kg/day and the maximum permissible intake(MpI) of 1.5 mg/kg/day are provisional. This Is because a number of multiple dose toxicity studies submitted to establish the ADI/MPI were conducted by IBT and have been determined to be invalid. Another reassessment and recalculation will be made when the studies required to fill the toxicology data gaps are submitted and reviewed. A petition for tolerance for residues in or on alfalfa forage and alfalfa hay must be submitted to support the alfalfa grown-for—seed use. No residue data are available. A petition for a food additive tolerace for apple pomace must be submitted. Tolerances: Commodity Parts Per Million Peaches 5 Grapefruit 4 Lemons 4 Limes 4 Nectarjnes 4 Oranges 4 Tangerines 4 Apples 3 Pears 3 Plums(fresh prunes) 2 4. SUMMARY OF REGULATORY POSITION AND RATIONALE The Agency has determined that it should continue to allow the registration of tormetanate HC1. Adequate studies are available to assess the acute toxicological effects of formetanate HC1 to humans. None of the criteria for unrea- sonable adverse effects listed in 40 CFR S162.1l(a) have been met or exceeded. However, because of gaps in the data ------- S base a full risk assessment of formetanate MCi cannot be made at this time. A full tolerance reassessment cannot be completed because of residue chemistry and tozicology data gaps. Available data are insufficient to fully assess the environ- mental fate of carbaryl. A 24—hour reentry interval has been established for tormetanate MC ].. This chemical appears to have the potential to contaminate groundwater. 5 • SUMMARY OF MAJOR DATA GAPS Residue data on alfalfa Chronic feeding studies — 2 species Oncogenicity studies — 2 species Teratogenicity studies — 2 species Reproduction studies — 2 species Hydrolysis study Nobility studies Photodegradation studies Dissipation studies Avian dietary LC 50 studies Aquatic organism testing 6. CONTACT PERSON AT EPA Jay S. Ellenberger Product Manager (12) Insecticide—Rodenticide Branch Regiatra on Divis ion (TS—767C) Office of Pesticide Programs Environmental Protection Agency 401 N Street, S. W. Washington, D. C. 20460 Office location and telephone number: Room 202, Crystal Mall 02 1921 Jefferson Davis Highway Arlington, VA 22202 (703) 557—2386 DISCLAIMER: The information presented in this Chemical Information Pact Sheet is for informational purposes only and may not be used to fulfill data requirements for pesticide registration and reregistration. ------- |