United Statej Office of Pertleidei and Toxic Substances Environmental ProMction Office of Pesticide Programs (TS-766C) Agency Washington, DC 20460 &EPA Pesticide Fact Sheet Name of Chemical: HEPTACHLOR Reason for Issuance: REGISTRATION STANDARD Date Issued: DECEMBER 1986 Fact Sheet Number: 1. DESCRIPTION OF CHEMICAL Generic Name: 1,4,5,6,7,8,8-heptachloro-3a,4 ,7,7a-tetra- (Chemical) hydro-4,7-methano-lH indene Common Name: Heptachlor Trade and Other Names: 1,4,5,6,7,8,8-heptachloro-3a,4,7 , 7a- tetrahydro-4,7-methanoindene; E-3314; Velsicol 104; Hep- tagran; Heptalube; heptachlore; Drinox H-34; Gold Crest H-60; Heptamul; and Heptox EPA Shaughnessy Code: 044801 Chemical Abstracts Service (CAS) Number: 76-44-8 Year of Initial Registration: 1952 Pesticide Type: Insecticide Chemical Family: Chlorinated cyclodiene U.S. and Foreign Producers: Velsicol Chemical Corporation 2. USE PATTERNS AND FORMULATIONS Application Sites: Soil surrounding wooden structures for termite control; control of fire ants in buried cable closures; above-ground structural application for control of termites and Bother wood-destroying insects. Types of Formulations: Emulsifiable concentrates; granular. Types and Methods of Application: Trenching, rodding, subslab injection, and low-pressure spray for subsurface termite control; caulking gun, trowel, or brush for applying to s tr uc t ur a1 wood. Application Rates: 0.06 to 1.0% emulsion for termite control; 0.2 oz/buried cable closure size 1 sq ft. 3. SCIENCE FINDINGS Summary Science Statement: Heptachlor is a chlorinated cyclodiene with moderate acute toxicity. The chemical has demonstrated adverse chronic effects in mice (causing liver tumors). Heptachlor may pose a significant health risk of ------- 2 chronic liver effects to occupants of structures treated with heptachior for termite control. This risk may be determined to be of regulatory concern, pending further evaluation. Heptachior is extremely toxic to aquatic organisms and birds. Heptachlor is persistent and bioaccum- ulates. Heptachlor may have a potential for contaminating surface water; thus, a special study is required to delineate this potential. Applicator exposure studies are required to determine whether exposure to applicators may be posing health risks. Special prociuct—specific subacute inhalation testing is required to evaluate the short—term respiratory hazards to humans in structures treated with heptachlor. An inhalation study of one (1) year duration using rats is required to assess potential hazards to humans in treated residences from this route of exposure. The Agency has been apprised of reported cases of optic neuritis associated with termiticide treatment of homes with a related cyclodiene, chiordane. To determine whether this is a significant health effect, and whether heptachior plays a role, the registrant must have eye tissue from the required 2—year rat oncogenicity study analyzed by neuropathologists specializing in optic tissue pathology. Data available to the Agency show an occur- rence of misuse and misapplication of heptachlor. The Agency is requiring restricted use classification of all end—use products (EPs) containing heptachior. Application must be made either in the actual physical presence of a Certified Applicator or if the Certified Applicator is not physically present at the site, each Uncertified Applicator must have completed a State—approved training course for termiticide application meeting minimal EPA training requirements and be registered in the State in which the Uncertified Applicator is working. Chemical/Physical Characteristics of the Technical Material Physical State: Crystalline solid Color: White Odor: Mild camphor-like odor Molecular Weight and ormula: 373.3 — C 10 H 5 C 1 7 Melting Point: 95 to 96 °C Boiling Point: 135—145 °C at 1—1.5 nunflg Density: 1.65—1.67 g/mL at 65° C Vapor Pressure: 0.0003 mmHg at 25 °C Solubility in Various Solvents: Soluble in ethanol, xylene, carbon tetrachloride, acetone, and benzene; practically insoluble in water. Stability: Stable in daylight, air, moisture, and moderate heat. ------- 3 Toxicology Characteristics Acute Oral: Data gap (except for a 74% technical formulation which showed the oral LD 50 value for male and female rats to be 208 mg/kg and 158 mg/kg, respectively. This places the 74% technical into Toxicity Category II). Acute Dermal: Data gap Primary Dermal Irritation: Data gap Primary Eye Irritation: Data gap Skin Sensitization: Not a sensitizer Acute Inhalation: Data gap Subacute Inhalation (2—week product—specific test using rats or guinea piqs): Data gap Chronic Inhalation (1 year using rats): Data gap Major Routes of Exposure: Inhalation exposure to occupants of treated structures; dermal and respiratory exposure to termiticide applicators. Delayed Neurotoxicity: Does not cause delayed neurotoxic effects. Oncogenicity: This chemical is classified as a Group B 2 oncogen (probable human oncogen). There are three long—term carcinoqenesis bioassays of heptachior in mice, which were independently conducted by investigators affiliated with the National Cancer Institute, the International Research and Development Corporation, and the Food and Drug Administra- tion. Reported in these studies were significant tumor responses in three different strains of mice (C 3 H, CF 1 , and B6C3F 1 ) in males and females with a dose—related increase in the proportion of tumors that were malignant. Available data from five existing carcinoqenicity bioassays in rats are inadequate and inconclusive and a well—designed study in rats for heptachior epoxide is needed to determine the carcinogenic potential of heptachior in this species. ------- 4 Chronic Feeding: Based on a dog chronic feeding study with heptachior epoxide, a lowest, effect level (LEL) of 0.0125 mg/kg/day for liver effects has been calculated. Data gaps exist for rodents and nonrodents for heptachlor epoxide and for heptachlor in nonrodents. Metabolism: In biological systems, heptachior is readily epoxidized to heptachior epoxide. Teratogenicity: Data gap Reproduction: A NOEL of 1.0 ppm has been set for repro- ductive effects to the young; the liver is - the target organ of effect. Mutagenicity: Sufficient evidence exists to conclude that neither heptachior nor heptachior epoxide possesses mutagenic activity in bacteria. Further testing is required to fulfill mutagenicity testing requirements in all three categories (gene mutation, structural chromosome aberrations, and other genotoxic effects). Physiological and Biochemical Characteristics The precise mode of action in biological systems is not known. In humans, signs of acute intoxication are primar- ily related to the central nervous system, including hyperexcitabilty, convulsions, depression, and death. Environmental Characteristics Data gaps exist for all applicable studies. However, available supplementary data indicate general trends of heptachior behavio in the environment. Heptachior is persistent and bioaccumulates. Heptachior is not expected to leach, since it is insoluble in water and should adsorb to the soil surface. Thus, it should not reach underground aquifers. However, additional data are necessary to fully assess the potential for ground water contamination as a result of heptachior’s termiticide use. Ecological Characteristics (technical grade) Avian Oral Toxicity: Data gap Avian Dietary Toxicity: 92, 224, and 480 ppm in bobwhite (8 days) . quail, pheasant, and mallard duck, respectively. ------- 5 Freshwater Fish Acute Toxicity: 13 ug/L for bluegill; (96—hr LC 50 ) 7.4 ug/L for rainbow trout. Freshwater Invertebrate Toxicity: 42 ug/L for Daphnia pulex ; (48—hr or 96—hr EC5O) 1.1 ug/L for Pteronarcys . 4. Required Unique Labeling and Regulatory Position Summary o EPA is currently evaluating the potential human health risks of 1) nononcogenic chronic liver effects, and 2) oncogenic effects to determine whether additional action on heptachlor may be warranted. o In order to meet the statutory standard for continued registration, retail sale and use of all EP5 containing heptachior must be restricted to Certified Applicators or persons under their direct supervision. For purposes of heptachlor use, direct supervision by a Certified Applicator means 1) the actual physical presence of a Certified Applicator at the application site during application, or 2) if the Certified Applicator is not physically present at the site, each Uncertified Applicator must have completed a State—approved training course in termiticide application meeting minimal EPA training requirements and be registered in the State in which the Uncertified Applicator is working. The Certified Applicator must be available if and when needed. o In order to meet the statutory standard for continued registration, heptachior product labels must be revised to provide specific disposal procedures and provide fish and wildlife toxicity warnings. o The Agency is requiring a special monitoring study to evaluate whether and to what extent surface water contam- ination may be resulting from the use of heptachlor as a termiticide. c o A new 2—year rat oncogenicity study is needed to determine the carcinogenic potential of heptachior epoxide. o Special product—specific subacute inhalation testing is required to evaluate the respiratory hazards to humans in structures treated with termiticide products containing heptachior. o Evaluation of eye tissue from the required 2—year rat oncogenicity study is required to determine whether hepta— chlor’s termiticide use may be causing optic neuritis in humans. ------- 6 o The Agency is requiring the submission of applicator exposure data from dermal and respiratory routes of exposure. o While data gaps are being filled, currently registered manufacturing—use products and EPs containing heptachlor may be sold, distributed, formulated, and used, subject to the terms and conditions specified in the Registration Standard for heptachlor , and any additional regulatory action taken by the Agency. Registrants must provide or agree to develop additional data in order to maintain existing registrations. 5. TOLERANCE REASSESSMENT No tolerance reassessment for heptachior is necessary, since there are no longer any food or feed uses. EPA is proceeding to revoke existing heptachlor tolerances and replace them with action levels. A Final Rule is scheduled for publication in the FEDERAL REGISTER in early 1987. 6. SUMMARY OF MAJOR DATA GAPS o Hydrolysis o Photodegradation in water o Aerobic soil metabolism o Anaerobic soil metabolism o Leaching and adsorption/desorptiofl o Aerobic aquatic metabolism o Soil dissipation o Chronic feeding — nonrodents and rats (heptachior epoxide) non—rodents (heptachior) o Oncogenicity — rats (heptachior epoxide) o Teratogenicity o Rat oncogenicity study o Mutagenicity studies o Acute toxicity studies o Optic tissue pathology ------- 7 o Special surface water monitoring stuales o Applicator exposure studies o Indoor air exposure studies o Special product—specific subchronic inhalation study (2—week duration using rats or guinea pigs) o Subchronic inhalation study (1—year duration using rats) o Avian acute oral toxicity o All product chemistry studies 7. CONTACT PERSON AT EPA George LaRocca Product Manager (15) Insecticide—Rodenticide Branch Registration Division (TS—767C) Office of Pesticide Programs Environmental Protection Agency’ 401 M Street SW. Washington, DC 20460 Office location and telephone number: Room 204, Crystal Mall #2 1921 Jefferson Davis Highway Arlington, VA 22202 (703) 557—2386 DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational purposes only and may not be used to fulfill data requirements for pesticide registration and reregistration. ------- |