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Mancozeb - Chemical Profile 4/87

Name of Chemical:  MANCOZEB
Reason for issuance:  REGISTRATION STANDARD
Date Issued:  APRIL,1987
Fact Sheet Number:
                      1.  DESCRIPTION OF CHEMICAL
Generic Name:  Manganese ethylene bisdithiocarbamte
Common Name:  Mancozeb
Trade Name.  Dithane M-45, Manzate 200, Fore
EPA Shaughnessy Code:  014504
Chemical Abstracts Service (CAS) Number:  8018-01-7
Year Of Initial Registration:  1967
Pesticide Type:  Fungicide (with minor insecticide use)
Chemical Family:  Ethylene bisdithiocarbamate (EBDC)
U.S. and Foreign Producers:  Rohm and Haas produces a
                             formulating intermediate;
                             E.I. Dupont deNemours Co.
                             produces mancozeb or its
                             own end-use products
                       2.  USE PATTERNS AND FORMULATIONS
Application Site:  Terrestrial rood and nonfood crops;
     aquatic (food); greenhouse (nonfood); forestry;
     outdoor domestic.
Major Crops Treated:  Apple, potatoes, and tomatoes.  Mancozeb
     is also used on approximately 80 percent of the onion acreage
     in the United States.
Formulation Types Registered:  80 percent active ingredient (ai)
     formulating intermediate; dust, wettable powder, flowable
     concentrate, and granular end-use products.
Methods of Application:  Foliar applications by aerial or
     ground equipment.  For ground equipment, mancozeb
     suspensions typically are made from a wettable powder or
     flowable concentrate that is applied by means of air
     blast sprayers or tractor-mounted boom sprayers.  Dust
     formulations are typically applied by means of truck - or
     tractor-drawn duster or aerial equipment.
    Treatment of the seeds may be accomplished by commercial
    seed treatment equipment by seed companies or by addition
    to the planter box at the farm site.  Mancozeb may be used
    as a spray furrow treatment of soil at planting of onion
    sets.  For treatment of surfaces of potato cut seed pieces
    or whole tuber seed pieces, mancozeb is applied by means
    of dip tanks or dusting equipment mounted over the seed
    pieces on a conveyor belt.
Application Rates:  Rates range from 0.4-3.3 lb/100 gal. or
    0.6-19.06 lb ai/A for foliar application (high rates are
    for turf use rather than food crops); 0.04-4.32 lb/100
    lb. of seed; 0.78-27 lb/100 gal for preplant dip treatments
    and 2.4 lb/A for soil applications.  Multiple applications
    may be made during the growing season.
Usual Carrier:  Water
                             3.  SCIENCE FINDINGS
Summary Science Statement:  The major toxicological concern
    from exposure to mancozeb is the hazard to the human
    thyroid from presence of ethylenethiourea (ETU), a con-
    taminant, degradation product, and metabolite present in
    mancozeb and other EDC products.  ETU is an acknowledged
    goitrogen, teratogen and oncogen.  Additional chronic
    studies of mancozeb are required for further evaluation.
    Available data indicate that mancozeb itself is not a
    primary developmental toxicant or teratogen, however, an
    additional teratology study with mancozeb is required
    before its teratogenicity can be fully realized.
    Available data are not adequate to assess the environ-
    mental fate of mancozeb.  However, studies do indicate
    that ETU has the potential to leach.  A complete assessment
    of the environmental rate, including the potential for
    groundwater contamination, from the use of mancozeb
    product will be undertaken when data are available.
    Available data are insufficient to completely evaluate
    the ecological effects of mancozeb.  Based on available
    data, mancozeb is no more than slightly toxic to avian
    wildlife on an acute bais; is highly toxic to warmwater
    fish; and appears to be at least moderately toxic to
    coldwater fish.
Chemical Characteristics:  Only limited product chemistry
    information is available, as follows:
    Physical state:  Solid at room temperature, decomposes
                     when heated.
    Empirical Formula:  (C4H6MnN2S4) x (Zn)y
    Molecular Weight:   (265.3) x +(65.4)y
Toxicology Characteristics:
    Acute Toxicity (Toxicity Categories are discussed in 40 CFR 162.10).
      Oral Toxicity:                    4500 mg/kg, Category III
      Dermal o%Toxicity:                > 5000 mg/kg, Category III
      Inhalation Toxicity:              > 5.14 mg/L, Category IV
      Eye Irritation:                   Primary Irritation Score (PIS) -
                                          2.3, Category III
      Skin Irritation:                  PIS - 0.5, Category I
      Dermal Sensitization:             Study required
    Subchronic Toxicity:
      Oral (rats):             No observed erect level (NOEL) for
                               kidney effects - 60 ppm (3.5 mg/kg/day,
                               males; 4.4 mg/kg/day females)
                               NOEL for thyroid effects - 125 ppm (7.9
                               mg/kg/day, males; 9.2 mg/kg/day, females)
      Oral (dogs):             NOEL for systemic effects - 100 ppm (3.0
                               mg/kg/day, males; 3.4 mg/kg/day, female)
                               NOEL for thyroid.d effects - 1000 ppm
                               (29 mg/kg/day for both sexes)
      Dermal:                  Studies required
      Inhalation:              NOEL for systemic erects - 20 mg/m3
                               NOEL for thyroid 80 mg/m3
      Major Routes of Exposure:  Dermal and Inhalation
Chronic Toxicity:
      Chronic Toxicity:  Studies required
      Oncogenicity:      Studies required
      Teratology:        Maternal toxicity: NOEL - 32 mg/kg/ay;
                           Lowest effects level (LEL) - 128
                           mg/kg/ay (decreased body weight)
                         Fetal toxicity: NOEL - 128 mg/kg/day;
                           LEL - 512 mg/kg/day ( Increased
                           resorptions)
                         Teratogenic effects: NOEL - 128
                           mg/kg/lay; LEL - 512 mg/kg/day
                           (dilated ventricles spinal cord
                           hemorrhage, delayed//incomplete
                           ossification of skull and ribs);
                           A/D Ratio: 32/128 = 0.25 (An A/D Ratio of
                           less than 1 indicates that developmental
                           toxicity may be ascribed to secondary affects
                           of maternal toxicity.
      Reproduction:       Study required
    Mutagenicity:  Negative - bacterial and in vitro mammalian
                              cell systems, chromosome damage
                              in vivo and in mammalian cell
                              transformation
                   Positive - sister-chromatid exchange in CHO
                              cells in vitro
Physiological and Behavioral Characteristics
    Mechanism Of Pesticide Action:  Mancozeb inhibits enzyme
      activity by complexing with metal-containing enzymes
      including those involved with the production of adenosine
      triphosphate (ATP).
    Metabolism:  Mancozeb appears to be rapidly absorbed from
      the gastrointestinal tract, distributed to target organs
      and excreted almost totally by 96 hours.  The major
      metabolite is ETU, comprising almost 24% of the bio-
      available dose in urine and bile.  ETU residues in
      the thyroid and the liver were less than 1 ppm and
      were non-detectable after 24 hours.
Environmental Characteristics:
  Hydrolysis:  Mancozeb degrades with a half-life of 1 to 2
    days at pH 5, 7, and 9.  ETU is table to hydrolysis at
    pH 5 and 7 and is very slowly hydrolyzed at pH 9.
  Anaerobic Aquatic Metabolism:  Mancozeb and ETU declined
    with half-lives of 92 days and 29 to 35 days, respectively.
  Environmental Fate/Groundwater Concerns:  Available studies
    indicate that ETU has the potential to leach.  A complete
    assessment of the environmental fate, including the
    potential for groundwater contamination, from the use of
    mancozeb products will be undertaken when data are available.
  Exposure During Reentry Operations:  Mancozeb is registered
    for use on crops which may involve substantial exposure
    to residue of the pesticide.  Because ETU has demonstrated
    evidence of oncogenicity, mutagenicity, teratogenicity and
    thyroid effect and mancozeb has caused thyroid effects,
    reentry data are required.  Until these data are received
    and evaluated, a 24-hour reentry interval is imposed.
Ecological Characteristics:
    Avian Oral Toxicity:
      Japanese Quail                 -  > 6400 mg/kg/day
      European Sparrow               -  3000-6000 mg/kg/day
      English House Sparrow          -  1500 mg/kg/day
      Mallard Duck                   - > 6400 mg/kg/day
    Freshwater Fish Toxicity:
      Bluegill sunfish               - 1.54 ppm
      Rainbow trout                  - 0.46 ppm
      Daphnia magna                  - 0.58 ppm
Tolerance Assessment:
     *****************************************************************
      SEE EBDC PROFILE FOR REGULATORY AND TOLERANCE ASSESSMENT UPDATE
     *****************************************************************
    Tolerances Established:  Tolerances, expressed as zinc
      ethylene bisdithiocarbamate, have been established for
      residues of mancozeb in a variety of raw agricultural
      commodities and meat byproduct (40 CFR 180.176 and
      40 CFR 180.319), and in processed food (21 CFR 193.460)
      and feed (21 CFR 561.410).
    Results of Tolerance Assessment:  The toxicology data for
      mancozeb are insufficient to determine an Acceptable
      Daily Intake (ADI) or whether the toxicity observed in
      the studies is due to mancozeb or ETU.
      There are no acceptable chronic studies on which to
      calculate an ADI, therefore, a subchronic study has been
      used to calculate a Provisional ADI (PADI).  Because a
      subchronic study was used, an uncertainty factor of 1000
      (rather than 100 used with chronic studies) was employed.
      The PADI for mancozeb is 0.003 mg/kg/day baed on the
      90-day dog feeding study with a NOEL of 3 mg/kg/day.
      The theoretical maximum residue contribution (TMRC),
      based on the assumption that 100 percent of each crop
      is treated and contains residue at the tolerance levels,
      is 0.028 mg/kg/day or approximately 900 percent of the PADI.
      Based on a more realistic d.dietary assessment, using average
      field trial residue and theoretical percent of crop teated,
      the estimated average consumption for the U.S. population
      is 0.00097 mg/kg/day or 32.2 percent of the PADI.
         4.  SUMMARY OF REGULATORY POSITION AND RATIONALE
     *****************************************************************
      SEE EBDC PROFILE FOR REGULATORY AND TOLERANCE ASSESSMENT UPDATE
     *****************************************************************
Summary of Agency Position:  The Agency is currently evaluating
    the potential human health risks resulting from the use of
    mancozeb to determine whether additional regulatory action
    is warranted on mancozeb and the other EBDC pesticides
    containing the common contaminant, degradation product,
    and metabolite, ETU.  At this time, the Agency will not
    establish any new food use tolerances or register any
    significant new uses.  The Agency is also specifying
    precautionary labeling as set forth below.
Unique Warning Statements Required on Label:
Manufacturing-Use Products
    "This pesticide is toxic to fish.  Do not discharge
    effluent containing this product into lake, streams,
    pond, estuaries, ocean, or public water unless this
    product is specifically identified and addressed in an
    NPDES permit.  Do not discharge effluent containing this
    product to sewer systems without previously notifying the
    sewage treatment plant authority.  For guidance, contact
    your State Water Board or Regional Office or the EPA."
End-Use Products
Outdoor Use Products (other than aquatic rood and seed
treatment)
    "This pesticide is toxic to fish.  Drift and runoff from
    treated area may be hazardous to aquatic organisms in
    neighboring area.  Do not apply directly to water or
    wetlands (swamps, bogs, marshes, and pothole).  Do not
    contaminate water by cleaning of equipment or disposal
    of wastes."
Seed Treatment Product
    "This pesticide is toxic to fish.  Cover or incorporate
    spilled treated seed.  Do not contaminate water by
    cleaning of equipment or disposal of wastes."
Aquatic Food Use Products (cranberry, wild rice, taro)
    "This pesticide is toxic to fish.  Drift and runoff
    from treated areas may be hazardous to aquatic
    organisms in neighboring areas.  Do not contaminate
    water by cleaning of equipment or disposal of wastes.".
All Home Use Products
    "PROTECTIVE MEASURES: Always spray with your back to
    the wind.  Wear long-sleeve shirt, long pants, 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 Food Uses
    "Preharvest intervals on this label are specified so
    that pesticide residues will be at an acceptable level
    when the crop is harvested."
All Agricultural Products
    "After (sprays have dried/dusts have settled/vapors
    have dispersed, as applicable) do not enter or allow
    entry into treated areas until the 24-hour reentry
    interval has expired unless wearing the personal pro-
    tective equipment listed on the label.
    "WORKER SAFETY RULES
    "Keep all unprotected persons, children, livestock, and
    pets away from treated area or where there is danger of
    drift.
    "Do not rub eye or mouth with hands.  See First Aid
    (Practical Treatment Section).
    "PERSONAL PROTECTIVE EQUIPMENT - For Mixers, Loaders,
    Applicator and Early Reentry Workers.
    "HANDLE THIS PRODUCT ONLY WHEN WEARING THE FOLLOWING
    PROTECTIVE CLOTHING AND EQUIPMENT: a long-sleeve
    shirt and long pants 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 application from a tractor with a completely
     enclosed cab with positive pressure filtration, or
     aerially with an enclosed cockpit, a long-sleeve
     shirt and long pants may be worn in place of the
     above protective clothing.  Chemical resistant gloves
     must be available in the cab or cockpit and worn
     while exiting.
     "IMPORTANT!  Before removing gloves, wash them with
     soap and water.  Always wash hands, face, and arm
     with soap and water before eating, smoking or drinking.
     Always wash hands and arms with soap 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 mancozeb must be destroyed according
     to state and local regulations.
     "HEAVILY CONTAMINATED OR DRENCHED CLOTHING CANNOT BE
     ADEQUATELY DECONTAMINATED.
     "During aerial application, human flaggers are
     prohibited unless in totally enclosed vehicles."
                      5.  SUMMARY OF MAJOR DATA GAPS
                                 Due Date - From Issuance
     Study                             of Standard
Product Chemistry                      6-15 months
Residue Chemistry:                    18-24 months (Dates are determined
  Plant and animal metabolism                     based on beginning of
  Residue studies                                 planting season
                                                  after issuance of
                                                  Standard.)
Toxicology:                            9-50 months
  Dermal sensitization
  Subchronic dermal
  Chronic toxicity (rodent and
    nonrodent) (mancozeb and ETU)
  Oncogenicity (rat and mouse)
  Teratology (rabbit)
  Reproduction (rat) (mancozeb and ETU)
  Mutagenicity (mancozeb and ETU)
  Dermal (percutaneous) absorption
    (mancozeb and ETU)
Ecological Effects:                    9-18 months
  Avian dietary
  Avian reproduction
  Estuarine and marine organism
  Fish early life stage
  Aquatic invertebrate life cycle
Environmental Fate:                    9-50 months
  Hydrolysis (mancozeb and ETU)
  Photodegradation (mancozeb and ETU)
  Soil metabolism (mancozeb and ETU)
  Aquatic metabolism (mancozeb and ETU)
  Leaching-and adsorption/desorption (mancozeb and ETU)
  Volatility
  Degradation (mancozeb and ETU)
  Rotational crops
  Irrigated crops
  Fish accumulation
Reentry                                27 months
                         6.  CONTACT PERSON AT EPA
Ms. Lois Rossi
Product Manager (Team 21)
Fungicide-Herbicide Branch
Registration Division (TS-767C)
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
FULFILL DATA REQUIREMENTS FOR PESTICIDE REGISTRATION AND
REREGISTRATION.