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   Viscosity:

   Miscibility:

   Corrosion
   Characteristics:

   Dielectric
   Breakdown Voltage:
            END USE PRODUCT
               (Sumagic)

            12.0 CPS @ 20 C

            N.R.


            Not corrosive


            N.A.
           TECHNICAL
         (Uniconazole)

             N.A.

             N.R.


           Not corrosive


             N.A.
Toxicology Characteristics
Acute Testing
Acute Oral:
   END USE PRODUCT
      (Sumagic)

LD50 > 5000 mg/kg
Toxicity Category-IV
  TECHNICAL
(Uniconazole)

LD5Q > 460-M,430-F mg/kg
Toxicity Category-II
Acute Dermal:  LDCQ > 5000 mg/kg
               Toxicity Category-Ill

Acute Inhala-  LC_Q > 5.9 mg/L
tion:          Toxicity Category-IV
Primary Dermal
Irritation:

Primary Eye
Irritation:
   Non-irritant
   Toxicity Category-IV

Slightly Irritating
Toxicity Category-Ill
   Q > 2000 mg/kg
Toxicity Category-Ill

LC50 > 2.75 mg/L
Toxicity Category-Ill

   Non-irritant
   Toxicity Category-IV

 Minimally irritating
 Toxicity Category-Ill
Dermal Sensitization:  Non-sensitizer  Non-sensitizer

Oncogen i c i ty

    In an 18-month mouse oncogenicity study, administration of
Uniconazole to Crl:CD-l mice at doses of 0, 10, 40, 200, or 1500
ppm (0, 1.5, 6, 30, and 225 mg/kg/day) resulted in a systemic
NOEL of 30 mg/kg/day, and a LOEL of 225 mg/kg/day.  These were
based on increased absolute and relative liver weights in males,
and increased relative liver weights in females, accompanied by
focal chronic inflammation, necrosis, and pigmented macrophages.
The HED Carcinogenicity Peer Review Committee evaluated the
compound and classified Uniconazole as a Group C, possible human
carcinogen.  The classification was based upon an increased
incidence of hepatocellular adenomas, carcinomas and adenomas/
carcinomas combined in high dose male CD-l^mice.  Quantification
using the low dose extrapolation model (Ql  ) was not recommended
because the tumor induced was primarily of benign nature,
occurred only at the highest dose tested, and occurred in only

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one sex of one species.  Therefore, the Reference Dose  (RFD)
approach will be used  for the estimation of potential human risk
for future registrations involving food/feed uses.

     A 2-year rat chronic/carcinogenicity study with rats fed
doses of 0, 10, 40, 200 or 1000 ppm yielded a systemic NOEL of
200 ppm and an LOEL of 1000 ppm, respectively, and was based
upon reduced body weight gain, increased centrilobular hepato-
cellular enlargement and vacuolization in males and females;
increased relative liver weights and total cholesterol values.
There was no evidence of carcinogenicity in the rat.

Subchronic Toxicity

     A 90 day oral toxicity study with dogs fed doses of
0, 5, 20, 80, or 320 mg/kg/day yielded a systemic NOEL of
5 mg/kg/day and a LOEL of 20 mg/kg, respectively.  These were
based on decreased food consumption and body weight, increased
SGPT and BSP retention, increased liver weights, heptocellular
enlargement and cytoplasmic vacuolation of hepatocytes  in
animals administered 20 mg/kg/day and above.

     A 90 day oral toxicity study with rats fed doses of
0, 30, 100, 1000, or 3000 ppm (approximate doses of male-
0, 2.25, 7.48, 73.0, 73.0, 228.0; female- 0, 2.24, 8.36, 79.0,
229.0 mg/kg/day) yielded a systemic NOEL of 100 ppm (10 mg/kg/
day) and a LOAEL of 1000 ppm  (100 mg/kg/day), respectively.
These were based on increased liver weights in males and females,
cloudy swelling of the liver  (M,F), decreases in several hema-
tology parameters (M,F), increased cholesterol and and phospho-
lipid (F).  In addition, at 3000 ppm, thyroid weights were
increased (M), with increased incidence of small follicles and
cytoplasmic vacuolation of the thyroid gland  (M).

Chronic Toxicity

     The requirement for a chronic oral dog study has been
satisfied.  The no-observed-effect-level (NOEL) is 2 mg/kg/day
and was based upon increased liver weights in male dogs.  Liver
weight also was increased in male and female dogs at 20 mg/kg/day
and correlated with hepatocellular enlargement, increased
cytoplasmic homogeneity and increased bile pigment.  The LOEL
is 20 mg/kg/day and was based on increased liver weight.

Chronic Toxicity- Rodent (Refer to rat chronic/oncogenicity study
above).

Developmental Toxicity

     A rat developmental study using doses of 0, 1, 5,  25, and
50 mg/kg/day showed incidence of 14th rib increases at  doses
of 25 mg/kg/day and above.  The incidence of cervical ribs
increased in the 5, 25, and 50 mg/kg/day dose groups.  The
historical control data showed the cervical ribs to be an un-
common skeletal abnormality.  This study was classified core-

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supplementary because of the following: a.  Inadequate
historical control data concerning the cervical ribs  b.              |
Inadequate description of mating procedures including the
method and rationale used to select the animals and the
method employed for "culling" these animals and c.  The term
"tubercle of the liver" is unclear and needs to be defined.
For purposes of risk characterization, a tentative NOEL of
of 1 mg/kg/day for developmental toxicity will be used to
determine the margin of exposure for potential human risk.
A tentative LOEL of 5 mg/kg/day for developmental toxicity
will be used based on increased evidence of cervical ribs
development at 5 mg/kg/day.  The NOEL for maternal toxicity
is 5 mg/kg/day, while the LOEL for maternal toxicity is
25 mg/kg/day.

     A rabbit developmental study using doses of 1, 3, 10,
and 20 mg/kg/day of Uniconazole yielded a maternal NOEL of 10
mg/kg/day based on reduced food consumption and body weight gain
during dosing.  The developmental NOEL was 20 mg/kg/day (HOT).
There were no treatment related increases in gross, visceral or
skeletal abnormalities.

Reproduction

     In a two generation reproduction study, rats were fed doses
of 0, 15, 150, or 1500 ppm (daily doses of approximately 0,
0.72, 7.5, and 75 mg/kg/day).  The NOEL for systemic toxicity
is 7.5 mg/kg/day, based on increased liver weight, liver hyper-       (
trophy and vacuolization.  The reproductive toxicity NOEL is 7.5
mg/kg/day, based on reduced pup weight during lactation.  The
LOEL was 75 mg/kg/day based on reduced pup body weight during
lactatation.  There was no other evidence of reproductive
toxicity.

Mutagenicity Testing

     No mutagenic activity was observed when tested in five
strains (TA1535, TA1537, TA1538, TA98 and TA100) of Salmonella
typhimurium or in E. coli with and without metabolic activation.
The in vitro chromosomal aberration test indicated negative
responses without activation at several concentrations of up to
and including 2x10   M, but was positive when tested with
activation at up to 3xlO~  M.  Iri vitro testing in Chinese
hamster ovary (CHO) cells was positive when tested with S-9
activation.  Uniconazole tested slightly positive  in DNA damage/
repair assay and mouse activation micronucleus tests; however,
these were graded unacceptable but upgradeable.

Environmental Characteristics

     Hydrolysis - Hydrolysis studies of the (S)-(E)-isomer
conducted at pH 5, 7 and 9 showed no degradation over a
30-day period.                                                         4

     Aerobic Soil Metabolism - Biodegradation is not an important
degradation mechanism for Uniconazole.  The half-life of Unicona-
zole in sandy loam soils is 390 days.

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     Mobility in soil - Uniconazole  is very mobile in sandy
loam and sand soils.

     Volatility from soil - Uniconazole  is not likely to
volatilize from soil.

     The Environmental Fate and Ground Water Branch  (EFGWB)
has determined that all the data requirements for green-
house non-food use have been satisfied:  hydrolysis, aerobic
soil metabolism and mobility in soil  (adsorption/desorption,
column leaching).  In summary, Uniconazole is characterized
by the tendency of the compound to persist in aqueous media
and in soils and for its leaching potential in soils of low
organic matter content.
Ecological Characteristics

Avian acute toxicity:
   Bobwhite Quail
   Mallard Duck

Avian dietary toxicity:
   Bobwhite Quail
   Mallard Duck
                          LD,-n 1461 mg/kg
                          LD^J: > 2315 mg/kg
'    >  5782 mg/kg
:5Q  3442 mg/kg
Freshwater fish acute
toxicity:
   Bluegill Sunfish  LC
   Rainbow Trout     LC
                       50
                       50
  6.80 ppm
  14.8 ppm
                                             Classification
                   Practically
                    Non-toxic
                                                Slightly Toxic
                                                Slightly Toxic
Slightly Toxic
Slightly Toxic
     Available data indicate that the risk to avian and aquatic
species will be minimal.  Uniconazole is slightly toxic to birds
on both an acute and dietary basis.

     The Agency does not believe that conditional registration
of this chemical will cause substantially greater adverse
effects to the environment than other triazole products.  Also,
the labelled use pattern, greenhouse, lathhouse and shadehouses
precludes environmental exposure.

                                                        No hazards
     Potential problems related to Endangered Species;
are expected to endangered species.

     Summary of Regulatory Positions

     As conditions of registration, the registrant must submit
additional information as listed below to upgrade the rat de-
velopmental study:

     1.  Historical control data concerning the phenomenon
         of 14th and cervical rib development.

     2.  A description of mating procedures including the method
         and rationale used to select the animals; and also
         the method employed for "culling" these animals.
     3.   A definition of the term "tubercle of the liver".

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                              8
    The registrant must submit also additional information to
upgrade the rat unscheduled DNA synthesis and the mouse In vivo
Micronucleus mutagenicity studies.

Required Unique Labeling

    To protect against leaching and runoff, the following label-
statements are being required:

    "This product has the potential to leach into groundwater or
to run off into surface water.  In Greenhouses, Lathhouses or
Shadehouses with soil flooring of high porosity and low organic
content, do not apply directly to soil or to plants/pots in
direct contact with soil"

    For worker protection, the following labeling is required?

    "Do not reenter treated areas until sprays have dried"

    "Wear protective clothing, long sleeved shirt, and rubber
gloves.  Remove contaminated clothing and wash before reuse."

Summary of Major Data Gaps

     The rat developmental study needs to be upgraded.
     Two mutagenicity studies need upgraded.

CONTACT PERSON AT EPA

   Robert J. Taylor
   Product Manager  (25)
   Fungicide-Herbicide Branch
   Registration Division  (H7505C)
   Office of Pesticide Programs
   Environmental Protection Agency
   401 M Street, S. W.
   Washington, D. C.  20460

   Office location  and telephone number:

   Room 245, Crystal Mall #2
   1921 Jefferson Davis Highway
   Arlington, VA  22202
   (703) 557-1800

DISCLAIMER:    The  information in this Pesticide  Fact Sheet
is a summary only and is  not  to be used to  satisfy data  require-
ments  for pesticide registration  and  reregistration.  The
complete Registration Standard for the pesticide  may be  obtained
from the contact person listed above.

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