United Stata Office of Perticidei «nd Toxic Sutntanca
Environmental Protection Office of Pettiade Programs (TS-766C)
Agency Washington, DC 20460
v>EPA Pesticide
Fact Sheet
Name of Chemical: MANCOZEB
Reason for Issuance: REGISTRATION STANDARD
Date Issued: APRIL^S?
Fact Sheet Number: 125
DESCRIPTION OF CHEMICAL
Generic Name: Manganese ethylene bisdithiocarbamate
Common Name: Mancozeb
Trade Name: Dithane« M-45, Manzate* 200, Pore*
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 for its
own end-use products
USE PATTERNS AND FORMULATIONS
Application Sites: Terrestrial food and nonfood crops;
aquatic (food); greenhouse (nonfood); forestry;
outdoor domestic.
Major Crops Treated: Apples, 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 (al)
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
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suspensions typically are made from a wettable powder or
flowable concentrate tI at 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 companle8 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/l00 gal. or
0.6—19.06 lb al/A for follar’ application (high rates are
for turf use rather than food crops); 0.04—4.32 lb/lOO
lb. of seed; 0.78—27 lb/l00 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
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 EBDC products. ETU is an acknowledged
goltrogen, 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 18 required
before its teratogenicity can be fully assessed.
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 fate, including the potential for
groundwater contamination, from the use of mancozeb
products 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 ba8i.s; is highly toxic to warmwater
fish; and appears to be at least moderately toxic to
co].dwater fish.
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Empirical Formula:
Molecular Weight:
Toxicology Characteristics ;
Acute Toxicity’!:
Oral Toxicity:
Dermal Toxicity:
Inhalation Toxicity:
Eye Irritation:
Skin Irritation:
Dermal Sensitization:
Subchronic Toxicity:
Oral (rats):
Dermal:
Inhalation:
Major Route8 of Exposure:
4500 mg/kg, Category III
> 5000 mg/kg, Category III
> 5.14 mg/L, Category IV
Primary Irritation Score (PIS) -
2.3, Category III
P13 — 0.5, Category IV
Study required
Chemical Characteristics : Only limited product chemistry
information is available, as follows:
Physical state: SolId at room temperature, decomposes
when heated.
(C 4 H 6 MnN 2 S 4 ) x (Zn)y
(265.3) x
Oral (dogs):
No observed effect 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)
NOEL for systemic effects — 100 ppm (3.0
mg/kg/day, males; 3 .1 mg/kg/day, females)
NOEL for thyroid effects — 1000 ppm
(29 mg/kg/day for both sexes)
Studies required
NOEL for systemic effects - 20 mg/rn 3
NOEL for thyroid 80 mg/rn 3
Dermal and Inhalation
1 /Toxlclty Categories are discussed in 40 CFR 162.10.
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Chronic Toxicity:
Chronic Toxicity: Studies required
Oncogenicity: StudIes required
Teratology: Maternal toxicity: NOEL — 32 mg/kg/day;
Lowest effects level (LEL) — 128
mg/kg/day (decreased body weight)
Petal toxicity: NOEL - 128 mg/kg/day;
LEL - 512 mg/kg/day (increased
resorptlons)
Teratogenic effects: NOEL — 128
mg/kg/day; LEL - 512 mg/kg/day
(dilated ventricles, spinal cord
hemorrhage, delayei/ incomplete
ossification of skull and ribs);
A/D Ratio: 32/128 = 0.252/
Reproduction: Study required
Mutagenicity: Negative - bacterial and in vitro mammalian
cell 8ystems, Hromosome damage
in vivo and in mammalian cell
t ans to rmat ion
Positive — sister—chromatid exchanges in CHO
cells in vitro
Physiological and Behavioral Characteristics
Mechanism of Pesticide Action: Mancozeb inhibits enzyme
activity by complexing with metal—containing enzymes
including tho8e 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
metabo]ite 18 ETU, cor prising almost 211% 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 214 hours.
Environmental Characteristics :
H ro1ys1s: Mancozeb degrades with a half—life of 1 to 2
days at pH 5, 7, and 9. ETU is stable to hydrolysis at
pH 5 and 7 and IS very slowly hydrolyzed at pH 9.
Anaerobic Aquatic Metaboli8m: Mancozeb and ETU declined
with half—lives of 92 days and 29 to 35 days, respectively.
rA AID Ratio of less than 1 indicates that developmental
toxicity may be ascribed to secondary affects of maternal
tgsy I v I I u -
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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
f or use on crops which may involve substantial exposure
to residues of the pesticide. Because ETU has demonstrated
evidence of oncogenicity, mutagenicity, teratogenicity and
thyroid effects and inancozeb has caused thyroid effects,
reentry data are required. Until these data are received
and evaluated, a 24—hour reentry interval is imposed.
Ecological Characteristics :
Aviari 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 :
Tolerances Established: Tolerances, expressed as zinc
ethylene bisdithiocarbamate, have been established for
residues of mancozeb in a variety of raw agricultural
commodities and meat byproducts (40 CFR 180.176 and
40 CFR 180.319), and in processed food (21 CYR 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 (AD!) 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 AD!, therefore, a subchronlc study has been
used to calculate a Provisional AD! (PADI). Because a
subchronic study was used 1 an uncertainty factor of 1000
(rather than 100 used with chronic studies) was employed.
The PAD! f or mancozeb is 0.003 mg/kg/day based 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 residues at the tolerance levels,
is 0.028 mg/kg/day or approximately 900 percent of the PAD!.
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Based on a more realistic dietary assessment, using average
field trial residues and theoretical percent of crop treated,
the estimated average consumption ror the U.S. population
is 0.00097 mg/kg/day or 32.2 percent of the PADI.
SUMMARY OF REGULATORY POSITION AND RATIONALE
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 Statement8 Required on Label8:
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
product 18 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 of the EPA.”
End—Use Products
Outdoor Use Products (other than aquatic food and seed
treatment)
“This pesticide is toxic to fi8h. Drift and runoff from
treated areas may be hazardous to aquatic organisms in
neighboring areas. Do not apply directly to water or
wetlands (swamps, bogs, marshes, and potholes). Do not
contaminate water by cleaning of equipment or disposal
of wastes.”
Seed Treatment Products
“This pesticide is toxic to fish. Cover or incorporate
spilled treated seed. Do not contaminate water by
cleaning of equipment or disposal of wastes.”
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Aquatic Food Use Products (cranberry, wild rice, taro)
“This pesticide 18 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 18 danger of’
drift.
“Do not rub eyes or mouth with hands. See First Aid
(Practical Treatment Section).
“ PERSONAL PROTECTIVE EQUIPMENT - For Mixers, Loaders,
Applicators 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, ani goggles
or a face 8hield. During mixing and loading, a
chemical resistant apron must also be worn.
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“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 ifl 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 arms
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.”
SUMMARY OF MAJOR DATA GAPS
Due Date - From Issuance
Study of Standard
Product Chemistry 6—15 months
Residue Chemistry: 18—214 months 3 !
Plant and animal metabolism
Residue studies
Toxicology: 9—50 months
Dermal sensitization
Subchronic dermal
Chronic toxicity (rodent and
nonrodent) (rnancozeb and ETU)
Oricogenicity (rat end mouse)
Teratology (rabbit)
Reproduction (rat) (mancozeb and ETU)
Mutagenicity (mancozeb and ETU)
Dermal (percutaneous) absorption
(mancozeb and ETU)
3 /Dates are determined based on beginning of planting season
— after issuance of Starilard.
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Due Date — From Issuance
Study of Standard
EcologIcal Effects: 9—18 months
Avlan dietary
Avian reproduction
Estuarine and marine organism
Fish early life stage
Aquatic invertebrate life cycle
Environmental Fate: 9—50 months
Hydr’olysi.s (mancozeb and ETU)
Photoclegradation (mancozeb and ETU)
Soil metabolism (mancozeb and ETU)
Aquatic metabolism (mancozeb and ETU)
Leaching and adsorption/desorptlon (mancozeb and ETU)
Vol at 11 It y
Degradation (mancozeb and ETU)
Rotational crops
Irrigated crops
Fish accumulation
Reentry 27 months
CONTACT PERSON AT EPA
MB. 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 pre8ented in this Pesticide Fact
Sheet Is for information purposes only and may not be used to
fulfill data requirements for pesticide registration and
reregistration.
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