Return to Adverse
Effects
ACTIVITY:
Fungicide (azole)
CAS Name:
1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H-1,2,4-triazole
Structure:
Adverse
Effects:
Amyloidosis
Blood
Body Weight Decrease
Bone
Brain
Cancer: Likely
to be Carcinogenic to Humans - LIVER
Cholesterol
Endocrine:
Ovary
Endocrine: Pituitary
Endocrine: Prostate
Endocrine: Testicular
Endocrine:
Thymus
Endocrine:
Thyroid
Endocrine: Uterus
Endocrine:
Vaginal
Kidney
Liver
Lung
Reproductive/Developmental |
Environmental:
Persistent
in soil and water sediment
Moderately toxic to birds
Highly toxic to fish, aquatic invertebrates, algae/aquatic
plants and sediment dwelling organisms
Hazardous to bees
Moderately toxic to earthworms |
Regulatory
Information
(only comprehensive for the US) |
US
EPA Registered: |
Yes |
US
EPA PC Code: |
120603 |
US
Tolerances: |
CFR
180.557 |
Registered
use in
(includes only a limited list of countries)
|
Brazil,
Greece, Hungary, Itally, Japan, Portugal, South Africa, Spain,
Taiwan, UK, US |
Japan's
Maximum Residue Levels (MRLs) |
Apple, Apricot, Artichoke,
Barley, Cherry, Cucumber,
Grape, Loquat, Makuwauri,
Melons, Nectarine,
Oriental pickling melon,
Other cereal grains,
Other cucurbitaceous vegs,
Peach, Pear, Plum,
Pumpkin (inc Squash),
Quince, Strawberry,
Sugar beet, Tomato,
Watermelon, Tea, Wheat |
US
Maximum Residue Levels permitted
in food commodities
|
Permitted
in or on 10 food commodities, including:
Cattle, Milk, Sugarbeets,
Sugarbeet-related commodities |
Other
Information |
Molecular
Formula: |
C13H11Cl2
F4 N3O |
Entry
Year: |
1993 |
Manufacturers: |
Isagro-Ricerca |
Other
Names: |
Arpege
Buongiorno
Domark
Eminent
Hokugard
Lospel
M 14360
TMF-931 |
Of
special interest: |
PAN
BAD ACTOR - Carcinogen |
January
26, 2007 - Tetraconazole:
Human-Health Risk Assessment for Proposed Uses on Soybean,
Sugar Beet, Peanut, Pecan, and Turf.
Federal Register Docket
#: EPA-HQ-OPP-2006-0576-0010. - 105 pages.
|
July
2007 - Summary
of toxicology data. California EPA, Department of Pesticide
Regulation, Medical Toxicology Branch. |
August
2005 - Evaluation
of Tetraconazole in the product Domark 40ME Fungicide.
Australian Pesticides and Veterinary Medicines Authority.
Detectable
residues are likely to occur in table grapes.
There are no import tolerances for tetraconazole residues
in/on table grapes in the major export markets (ie Hong
Kong, Singapore and Malaysia). In contrast to the wine industry,
the table grape industry does not have the same QA programs
in place to manage chemical residues in exported produce.
The table grape industry should be made aware that residues
of tetraconazole may present a risk to Australia’s
export trade in this commodity. (page 14)
|
April
2005 - EPA Pesticide
Fact Sheet: Tetraconazole.
The end-use product,
Eminent 125SL, contains 11.6% tetraconazole by weight
and is a liquid fungicide for control of Cercospora leafspot
and powdery mildew on sugar beets. The proposed application
method is ground and aerial application as a foliar spray
or by chemigation. The applications must by alternated with
non-triazole fungicides. Applications should begin when
disease conditions are favorable and be repeated at 21-28
day intervals. A maximum of two applications per growing
season may be made using 13 fluid ounces of a 1pound per
gallon product per acre. The preharvest interval is 14 days.
The product is for agricultural use only. The pesticide's
use is proposed in seven U.S. states: CO,
MI, MN, MT, ND, NE, and WY.
|
April
27, 2005 - U.S. Congressman David Price (D-NC) introduced
a bill "to suspend temporarily the duty on Tetraconazole"
up to December 31, 2009. The bill was referred to the House
Committee on Ways and Means. |
March
24, 2005 - Tetraconazole, which will be sold as Domark in the
United States ... contains the triazole class of chemistry that
is currently used on 75 percent of all soybean acres treated
in Brazil...
.......Valent recently acquired
the rights to sell Domark fungicide in the U.S. soybean market
from Isagro SpA...
.......Domark is now available
for use in Alabama, Arkansas, Delaware, Georgia, Illinois, Indiana,
Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota,
Mississippi, Missouri, Nebraska, New York, North Carolina, North
Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South
Dakota, Texas, Virginia, West Virginia and Wisconsin for the
control of Asian soybean rust under a Section 18.
Delta Farm Press. |
April
2002 -
Beer in the UK: 23 organofluorine
pesticides approved for use on malting barley. Published
by the British Beer and Pubs Association and Brewing Research
International. |
August
2001 - IR-4
New Products/Transitional Solution List This
list contains brief descriptions of numerous new pest control
materials that have been introduced over the last several years.
Additionally, it contains information on some "older"
crop protection chemicals that are believed to have room for
new uses. This List includes:
Tetraconazole |
October
2001 -
Glossary
of Pesticide Chemicals. A listing
of pesticides subject to analysis of residues in foods and feeds
by the US Food and Drug Administration. |
Hazard Characterization (Page
13)
1,2,4-triazole (free triazole)
is a metabolite common to a number of triazole-derivative
pesticides, and is found in both mammalian (rat) and plant
metabolism studies. Although for most
pesticides, mammals convert only a small proportion to free
triazole (less than 25%), two
compounds (tetraconazole and flusilazole)
demonstrate relatively high conversion (68-77%) in rat metabolism
studies. ...(Ref:
Human
Health Aggregate Risk Assessment for Triazole-derivative
Fungicide Compounds (1,2,4-Triazole, Triazole Alanine,
Triazole Acetic Acid). US EPA, February 7, 2006.)
Tetraconazole Metabolites
EPA "has determined that three toxicologically different
groups of compounds are of concern following application
of tetraconazole. The implications
for risk assessment of these groups are discussed below.
Free triazole metabolites (includes 1,2,4-triazole (T),
triazolyl alanine (TA), triazolyl acetic acid (TAA), triazolyl
hydroxypropionic acid (THP), and/or all labile conjugates
of these compounds): HED has previously addressed the toxicity
of T, TA and TAA in D322215 (HED
Risk Assessment Document; M. Doherty et al., 7-Feb-2006).
Please refer to this document for information concerning
the toxicity of these free triazole metabolites. The free
triazole risk assessment mentioned above pertains to exposure
to T, TA, and TAA from the conazole/triazole fungicides.
Tetraconazole results in the formation
of these compounds as well as THP. THP is a residue
of concern in rotational crops and livestock (included as
a residue of concern in livestock based on the identification
in rotational crops and therefore as a potential residue
in feed). Based on the proposed application rates and the
results of the confined rotational crop studies, HED has
concluded that residues in rotational crops will be negligible;
therefore, residue of THP will be negligible and the previous
free-triazole risk assessment is acceptable.
(Ref: Tetraconazole:
Human-Health Risk Assessment for Proposed Uses on Soybean,
Sugar Beet, Peanut, Pecan, and Turf.
January 26, 2007 - 105 pages
Docket #: EPA-HQ-OPP-2006-0576-0010)
|
US
Federal Register
••
Note: Due to length, the following is a partial
list. Click here
to see full list of FR entries.
|
Published
date |
Docket
Identification Number |
Details |
April 11, 2007 |
EPA-HQ-OPP-2006-0576 |
Sipcam Agro USA,
Inc. and Isagro S.p.A. Pesticide
Tolerance. FINAL RULE.
• Human
Health Aggregate Risk Assessment for Triazole-derivative Fungicide
Compounds (1,2,4-Triazole, Triazole Alanine, Triazole
Acetic Acid). US EPA, February 7, 2006.
Hazard Characterization
(Page 13)
1,2,4-triazole (free triazole) is a metabolite common to
a number of triazole-derivative pesticides, and is found
in both mammalian (rat) and plant metabolism studies. Although
for most pesticides, mammals convert only a small proportion
to free triazole (less than 25%), two compounds
(tetraconazole and flusilazole) demonstrate relatively high
conversion (68-77%) in rat metabolism studies.
As a plant metabolite, and given the wide use of triazole-derivative
pesticides (used as fungicides on many crops as well as
on turf) free triazole is found in a variety of food commodities,
including animal byproducts. 1,2,4-triazole appears to be
relatively stable in the environment, and may be found in
rotational crops as well as in water. ...
Documents in the Federal Register
Docket:
Tetraconazole:
Human-Health Risk Assessment for Proposed Uses on Soybean,
Sugar Beet, Peanut, Pecan, and Turf.
January 26, 2007 - 105 pages
Docket #: EPA-HQ-OPP-2006-0576-0010
Tetraconazole.
Dietary Exposure and Risk Assessment. Application of Tetraconazole
to Pecan, Sugar Beet, and Soybean.
January
23, 2007 - 39 pages
Docket #: EPA-HQ-OPP-2006-0576-0011
Notice
of Filing Sipcam Agro USA (PP#9F6023 and PP#6F7084)
Undated - 9 pages
Docket #: EPA-HQ-OPP-2006-0576-0004
Notice
of Filing Sipcam Agro USA (PP#9F5066)
- Undated - 6
pages
Docket #: EPA-HQ-OPP-2006-0576-0005
Notice
of Filing PP#576971 Isagro -
Undated - 6 pages
Docket #: EPA-HQ-OPP-2006-0576-0007
Projected
Percent Crop Treated for the Fungicide Tetraconazole
- November 29,
2006 - 9 pages
Docket #:
EPA-HQ-OPP-2006-0576-0009
Commodity |
PPM |
Aspirated grain fractions |
1.0 |
Beet sugar, dried pulp |
0.15 |
Beet sugar, molasses |
0.15 |
Beet sugar, root |
0.05 |
Cattle, fat |
0.02 |
Cattle, liver |
0.20 |
Cattle, meat |
0.01 |
Cattle, meat byproducts (except liver) |
0.01 |
Eggs |
0.02 |
Goat, fat |
0.02 |
Goat, liver |
0.20 |
Goat, meat |
0.01 |
Goat, meat byproducts (except liver) |
0.01 |
Hog, fat |
0.01 |
Hog, liver |
0.05 |
Hog, meat |
0.01 |
Hog, meat byproducts (except liver) |
0.01 |
Horse, fat. |
0.02 |
Horse, liver |
0.20 |
Horse, meat |
0.01 |
Horse, meat byproducts (except liver) |
0.01 |
Milk |
0.01 |
Milk, fat |
0.25 |
Peanut |
0.03 |
Peanut, oil |
0.10 |
Pecan |
0.04 |
Poultry, fat |
0.05 |
Poultry, meat |
0.01 |
Poultry meat byproducts |
0.01 |
Sheep, fat |
0.02 |
Sheep, liver |
0.20 |
Sheep, meat |
0.01 |
Sheep, meat byproducts (except liver) |
0.01 |
Soybean, refined oil |
0.80 |
Soybean, seed |
0.15 |
|
December 20, 2006 |
EPA-HQ-OPP-2006-0576 |
Sipcam Agro
USA, Inc. Pesticide
petitions.
Pesticide Petition PP 6F7084.
in or on the food commodity
-- pecan at 0.05 ppm.
Pesticide Petition PP 9F6023.
in or on the food commodity
-- peanut, nutmeat at 0.05 ppm
-- peanut, refined oil at 0.15 ppm.
Pesticide Petition PP 9F5066.
in or on the food commodities
-- sugarbeet roots at 0.05 ppm
-- sugarbeet top at 3.0
-- sugarbeet dried pulp at 0.15 ppm
-- sugarbeet molasses at 0.15 ppm
-- meat of cattle, goat, horse and sheep at 0.05 ppm
-- liver of cattle, goat, horse and sheep at 4.0 ppm
-- fat of cattle, goat, horse and sheep at 0.30 ppm
-- meat byproducts, except liver, of cattle, goat, horse and
sheep at 0.10 ppm
-- milk at 0.05 ppm. |
July 26, 2006 |
EPA-HQ-OPP-2006-0576 |
Isagro S.p.A.
Pesticide
petition: PP 5F6971.
To establish a new tolerance for residues of the fungicide tetraconazole
in or on food commodities
-- soybean, aspirated grain fractions/refined oil at 0.5 parts
ppm
-- soybean, seed at 0.1 ppm
-- poultry, fat at 0.05 ppm
-- poultry, egg/ liver/meat/meat byproducts at 0.01 ppm.
|
Dec
21, 2005 |
EPA-HQ-OPP-2004-0388 |
Pesticide
Product Registrations; Conditional Approval. Notice.
This notice
announces Agency approval of applications submitted by Sipcam
Agro, USA Inc. to conditionally register the pesticide products,
Tetraconazole Technical, EPA Registration Number 60063-11
and Eminent 125 SL Fungicide, EPA Registration Number 60063-12,
containing a new active ingredient not included in any previously
registered products pursuant to the provisions of section
3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended.
EPA issued
a notice, published in the Federal
Register of October 20, 1999 which announced that Sipcam
Agro, USA Inc., 70 Mansell Court, Suite 230, Roswell, GA 30076
submitted an application to register the following two pesticide
products:
1. Tetraconazole Technical, (EPA File Symbol:
60063-RR). Active ingredient: Tetraconazole: at 97.0%. The
application for the product Tetraconazole Technical was approved
for manufacturing or formulating purposes on April 14, 2005,
to use for formulation into end-use products for
use on sugar beets (EPA Registration Number 60063-11).
2. Eminent 125SL Fungicide, (EPA File Symbol:
60063-RE). Active ingredient: Tetraconazole: at 11.6%. The
application for the product Eminent 125SL was approved on
April 14, 2005 for the control of Cercospora leaf spot and
powdery mildew disease of sugar beets
(EPA Registration Number 60063-12).
The Agency
has considered the available data on the risks associated
with the proposed use of tetraconazole, and information on
social, economic, and environmental benefits to be derived
from such use. Specifically, the Agency has considered the
nature and its pattern of use, application methods and rates,
and level and extent of potential exposure. Based on these
reviews, the Agency was able to make basic health and safety
determinations which show that use of tetraconazole during
the period of conditional registration will not cause any
unreasonable adverse effect on the environment, and
that use of the pesticide is, in the public interest.
A
paper copy of the fact sheet, which provides more detail on
this registration, may be obtained from the National Technical
Information Service (NTIS), 5285 Port Royal Rd., Springfield,
VA 22161. [See
EPA's April 2005 Fact Sheet - note that tetraconazole
is classified as "likely to be carcinogenic to humans“
based on the occurrence of liver tumors in male and female
mice.] In accordance with section 3(c)(2) of FIFRA,
a copy of the approved label, the list of data references,
the data and other scientific information used to support
registration, except for material specifically protected by
section 10 of FIFRA, are also available for public inspection.
Requests for data must be made in accordance with the provisions
of the Freedom of Information Act and must be addressed to
the Freedom of Information Office (A-101), 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001. The request should:
Identify the product name and registration number and specify
the data or information desired.
••
Comments
submitted to US EPA on this Notice from FAN Pesticide Project.
••
FOIA
Request for documents on tetraconazole. |
August
31, 2005 |
OPP-2005-0223 |
Pesticide
Emergency Exemptions:
•
New Jersey. EPA authorized the use of
tetraconazole on soybeans to
control soybean rust; April 25, 2005 to November 10, 2007.
Contact: (Andrew Ertman)
• Tennessee. EPA authorized
the use of tetraconazole on soybeans
to control soybean
rust; April 25, 2005 to November 10, 2007. Contact: (Andrew
Ertman).
• Vermont. EPA authorized
the use of tetraconazole on soybeans
to control soybean
rust; June 23, 2005 to November 10, 2007. Contact: (Andrew
Ertman) |
July
13, 2005 |
OPP-2005-0188 |
Pesticide
Emergency Exemptions:
Minnesota: Crisis: EPA authorized
the use of tetraconazole on soybeans
to control soybean rust; March 2, 2005, to March 1, 2008.
South Dakota: Quarantine: EPA authorized
the use of tetraconazole on soybeans
to control soybean rust; March 2, 2005, to March 1, 2008. |
June
1, 2005 |
OPP-2005-0078 |
Pesticide
Tolerances for Emergency Exemptions. Final Rule.
This regulation establishes time-limited
tolerances for residues of tetraconazole in or on
Commodity |
Parts
per million |
Expiration/
revocation date |
Egg |
0.03 |
12/31/09 |
Poultry,
fat |
0.004 |
12/31/09 |
Poultry,
liver |
0.03 |
12/31/09 |
Poultry,
meat |
0.0003 |
12/31/09 |
Poultry,
meat byproduct, except liver |
0.002 |
12/31/09 |
Soybean,
seed |
0.05 |
12/31/09 |
The
States of Minnesota and South Dakota, as lead state agencies
in what is essentially a ``national'' section 18 request for
all soybean growing States... Soybean
rust has been designated as a biosecurity threat and
therefore, it is important that control measures be available
for the disease.
For
purposes of this section 18 petition, parent tetraconazole
is being considered. The Agency does have concern about potential
toxicity of 1,2,4-triazole and two conjugates, triazolylalanine
and triazolyl acetic acid. These three compounds are metabolites
to most of the triazole-containing fungicides. To
support the extension of existing parent triazole-derivative
fungicide tolerances, EPA conducted an interim human health
assessment for aggregate exposure to 1,2,4-triazole. The exposure
and risk estimates presented in this assessment are overestimates
of actual likely exposures and therefore, should be considered
to be highly conservative. Based on this assessment EPA concluded
that for all exposure durations and population subgroups,
aggregate exposures to 1,2,4-triazole are not expected to
exceed its level of concern. This
assessment should be considered interim due to the ongoing
series of studies being conducted by the U.S.
Triazole Task Force (USTTF). Those
studies are designed to provide the Agency with more complete
toxicological and residue information for free triazole and
are expected to be submitted to the Agency in late 2004.
Upon
completion of the review of these data, EPA will prepare a
more sophisticated assessment based on the revised toxicological
and exposure databases.
The most recent estimated aggregate
risks resulting from the use of tetraconazole, are discussed
in the Federal Register of April 22, 2005 final rule (see
below) establishing tolerances
for residues of tetraconazole in/on sugarbeet and livestock
commodities. In
that prior action, risk was estimated assuming tolerance level
residues in all commodities for established and proposed tolerances,
including the tolerances for soybean and animal commodities
discussed in this document. |
••
Note: Due to length, the above is a partial list.
Click here
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