Return to Flucarbazone-sodium
Index Page
Activity: Herbicide
(Triazolone)
Structure:
Adverse
Effects:
Body
Weight Decrease
Bone
Endocrine: Thyroid
Endocrine: Uterus
Immunological effects
Liver
Stomach
Environmental
As
of February 14, 2005, this herbicide is permitted in
or on 20 food commodities
in the United States - see list at bottom of page.
|
Body
Weight Decrease
(click on for all fluorinated
pesticides)
SUBCHRONIC/CHRONIC
TOXICITY
-- Study # 870.3150. 28-Day oral toxicity in nonrodents (dogs)
NOAEL = 164 mg/kg/day in males and 171 mg/kg/day in females. LOAEL
= 1,614 mg/kg/day in males and 1,319 mg/kg/day in females based
on decreased body weight gain, decreased
food consumption, decreased
T4 levels and increased thyroxine-binding capacity, induction
of microsomal enzymes, increased liver weight and liver histopathology
in both sexes.
-- Study # 870.3700b. Prenatal developmental toxicity in rabbits
Maternal NOAEL = 100 mg/kg/day LOAEL = 300 mg /kg/day based on
decreased food consumption and increased
clinical signs Developmental NOAEL = 300 mg/kg/day LOAEL = 500
mg/kg/day based on decreased fetal weight
and increased incidence of delayed fetal
ossification
-- Study # 870.3800. Reproduction and fertility effects in rats
Parental/Systemic NOAEL = 287 mg/kg/day for males and 340 mg/kg/day
for females with a slight, increased incidence of moderate cecal
enlargement occurring as an adaptive response to treatment. LOAEL
= 800 mg/kg/day for males based decreased
liver weight and 991 mg/kg/day for females based on decreased
uterine weight and increased incidence of severe cecal enlargement.
Reproductive/Offspring NOAEL = 287 mg/kg/day for males
and 340 mg/kg/day for females LOAEL = 800 mg/kg/day for males
and 991 mg/kg/day for females based on reduced
pup weights, decreased liver weight
in male pups, marbled liver, air filled stomach
-- Study # 870.4100b. Chronic toxicity in dogs NOAEL = 35.9 mg/kg/day
in males and 37.1 mg/kg/day in females. LOAEL = 183 mg/kg/day
in males and 187 mg/kg/day in females based upon body
weight gain depression and increased N-demethylase levels
in both sexes, decreased T4 levels and marginally increased
liver weight in females.
-- Study # 870.4300. 2-Year Chronic toxicity/carcinogenicity in
rats NOAEL = 125 mg/kg/day in males and females LOAEL = 1,000
mg/kg/day in males and females based on
decreased body weight and increased food
consumption in females,
thickened mucosa of the glandular stomach
in both sexes, inflammatory infiltrates (males), vacuolation of
the squamous epithelium in the fore-stomach (females) and immunological
effects in males. no evidence of carcinogenicity
-- Aquatic:
Flucarbazone-sodium is practically non-toxic to freshwater fish
on an acute basis (96- hour LC50 > 96.7 ppm).
With chronic exposure, flucarbazone-sodium
reduces fish growth at 2.75 ppm, with a
No Observable Adverse Effects Concentration (NOAEC) established
at 1.25 ppm (1250 ppb). It is practically non-toxic
to freshwater invertebrates on an acute basis (EC50 > 109 ppm)
and does not reduce reproduction of aquatic invertebrates at the
NOAEC of 115 ppm (115,000 ppb). The NOAECs for fish and aquatic
invertebrates are well above the peak estimated environmental
concentration (EEC) in water of 1.42 ppb.
Ref: US EPA Pesticide Fact Sheet for Flucarbazone-sodium.
September 29, 2000.
Ref: US EPA Pesticide Fact Sheet for Flucarbazone-sodium.
September 29, 2000.
http://www.epa.gov/opprd001/factsheets/flucarbazone.pdf
Bone
(click on for all fluorinated pesticides)
Prenatal development:
LOAEL = 500 mg/kg/ day based on decreased fetal weight and increased
incidence of delayed fetal ossification...
Ref: Federal Register. September 29, 2000.
Flucarbazone-sodium; Time-Limited Pesticide Tolerances. Final
Rule.
http://www.fluoridealert.org/pesticides/Flucarbazone_Na.FR.Sept2000.htm
Endocrine:
Thyroid
(click on for all fluorinated pesticides)
-- 90-Day oral toxicity
in nonrodents (dogs). NOAEL = 33.8 mg/kg/day in males and 35.2
mg/kg/day in females with the occurrence of slight, adaptive induction
of hepatic microsomal enzymes LOAEL = 162 mg/kg/ day in males
and 170 mg/kg/day in females based on decreased
T4 levels, increased thyroxine-binding capacity, induction
of microsomal enzymes, gross pathology and histopathology in the
stomach, and histopathology in the liver in both sexes.
-- One year dog feeding LOAEL = 183 mg/kg/day based on decreased
body weight gain, decreased thyroxine,
increased N- demethylase, and increased liver weight.
-- 28-Day oral toxicity in nonrodents (dogs). NOAEL = 164 mg/kg/
day in males and 171 mg/kg/day in females LOAEL = 1,614 mg/kg/
day in males and 1,319 mg/kg/day in females based on decreased
body weight gain, decreased food consumption, decreased
T4 levels and increased thyroxine-binding capacity, induction
of microsomal enzymes, increased liver weight and liver histopathology
in both sexes.
Ref: Federal Register. September 29, 2000.
Flucarbazone-sodium; Time-Limited Pesticide Tolerances. Final
Rule. http://www.fluoridealert.org/pesticides/Flucarbazone_Na.FR.Sept2000.htm
SUBCHRONIC/CHRONIC
TOXICITY
-- Study # 870.3100. 28-Day oral toxicity in rodents (rats) NOAEL
= 27 mg/kg/day in males and 25 mg/kg/day in females. LOAEL = 266
mg/kg/day in males and 251 mg/kg/day in females based on
immunological changes in both sexes.
-- Study # 870.3150. 90-Day oral toxicity in nonrodents (dogs)
NOAEL = 33.8 mg/kg/day in males and 35.2 mg/kg/day in females
with the occurrence of slight, adaptive induction of hepatic microsomal
enzymes. LOAEL = 162 mg/kg/day in males and 170 mg/kg/day in females
based on decreased T4 levels,
increased thyroxine-binding capacity, induction of microsomal
enzymes, gross pathology and histopathology in the
stomach, and histopathology in the liver
in both sexes.
-- Study # 870.3100. 90-Day oral toxicity in rodents (rats) NOAEL
= 73.5 mg/kg/day in males and 102 mg/kg/day in females LOAEL =
287 mg/kg/day in males and 358 mg/kg/day in females based on immunological
findings in both sexes
-- Study # 870.4300. 2-Year Chronic toxicity/carcinogenicity in
rats NOAEL = 125 mg/kg/day in males and females LOAEL = 1,000
mg/kg/day in males and females based on
decreased body weight and increased food consumption in females,
thickened mucosa of the glandular stomach in both sexes, inflammatory
infiltrates (males), vacuolation of the squamous epithelium in
the fore-stomach (females) and immunological
effects in males. no evidence of carcinogenicity
-- Study # 870.4100b. Chronic toxicity in dogs NOAEL = 35.9 mg/kg/day
in males and 37.1 mg/kg/day in females. LOAEL = 183 mg/kg/day
in males and 187 mg/kg/day in females based upon body
weight gain depression and increased N-demethylase levels
in both sexes, decreased T4 levels
and marginally increased liver weight
in females.
-- Study # 870.3150. 28-Day oral toxicity in nonrodents (dogs)
NOAEL = 164 mg/kg/day in males and 171 mg/kg/day in females. LOAEL
= 1,614 mg/kg/day in males and 1,319 mg/kg/day in females based
on decreased body weight gain, decreased
food consumption, decreased T4 levels and
increased thyroxine-binding capacity, induction of microsomal
enzymes, increased
liver weight and liver histopathology in both sexes.
Ref: US EPA Pesticide Fact Sheet for Flucarbazone-sodium.
September 29, 2000. http://www.epa.gov/opprd001/factsheets/flucarbazone.pdf
Endocrine:
Uterus (click
on for all fluorinated pesticides)
-- Study # 870.3800.
Reproduction and fertility effects in rats Parental/Systemic NOAEL
= 287 mg/kg/day for males and 340 mg/kg/day for females with a
slight, increased incidence of moderate cecal enlargement occurring
as an adaptive response to treatment. LOAEL = 800 mg/kg/day for
males based decreased liver weight
and 991 mg/kg/day for females based on decreased
uterine weight and increased incidence of severe
cecal enlargement. Reproductive/Offspring NOAEL = 287 mg/kg/day
for males and 340 mg/kg/day for females LOAEL = 800 mg/kg/day
for males and 991 mg/kg/day for females based on reduced pup weights,
decreased liver weight
in male pups, marbled liver, air filled stomach
Ref: US EPA Pesticide Fact Sheet for Flucarbazone-sodium.
September 29, 2000. http://www.epa.gov/opprd001/factsheets/flucarbazone.pdf
Immunological
effects
(click
on for all fluorinated pesticides)
SUBCHRONIC/CHRONIC
TOXICITY
-- Study # 870.3100. 28-Day oral toxicity in rodents (rats) NOAEL
= 27 mg/kg/day in males and 25 mg/kg/day in females. LOAEL = 266
mg/kg/day in males and 251 mg/kg/day in females based on
immunological changes in both sexes.
-- Study # 870.3100. 90-Day oral toxicity in rodents (rats) NOAEL
= 73.5 mg/kg/day in males and 102 mg/kg/day in females LOAEL =
287 mg/kg/day in males and 358 mg/kg/day in females based on immunological
findings in both sexes
-- Study # 870.4300. 2-Year Chronic toxicity/carcinogenicity in
rats NOAEL = 125 mg/kg/day in males and females LOAEL = 1,000
mg/kg/day in males and females based on
decreased body weight and increased food consumption in females,
thickened mucosa of the glandular stomach in both sexes, inflammatory
infiltrates (males), vacuolation of the squamous epithelium in
the fore-stomach (females) and immunological
effects in males. no evidence of carcinogenicity
Ref: US EPA Pesticide Fact Sheet for Flucarbazone-sodium.
September 29, 2000.
http://www.epa.gov/opprd001/factsheets/flucarbazone.pdf
Liver
(click
on for all fluorinated pesticides)
SUBCHRONIC/CHRONIC
TOXICITY
-- Study # 870.3150. 90-Day oral toxicity in nonrodents (dogs)
NOAEL = 33.8 mg/kg/day in males and 35.2 mg/kg/day in females
with the occurrence of slight, adaptive induction of hepatic microsomal
enzymes. LOAEL = 162 mg/kg/day in males and 170 mg/kg/day in females
based on decreased T4 levels, increased thyroxine-binding capacity,
induction of microsomal enzymes, gross pathology and histopathology
in the stomach, and histopathology
in the liver in both sexes.
-- Study # 870.3800. Reproduction and fertility effects in rats
Parental/Systemic NOAEL = 287 mg/kg/day for males and 340 mg/kg/day
for females with a slight, increased incidence of moderate cecal
enlargement occurring as an adaptive response to treatment. LOAEL
= 800 mg/kg/day for males based decreased
liver weight and 991 mg/kg/day for females based on decreased
uterine weight and increased incidence of severe
cecal enlargement. Reproductive/Offspring NOAEL = 287 mg/kg/day
for males and 340 mg/kg/day for females LOAEL = 800 mg/kg/day
for males and 991 mg/kg/day for females based on reduced pup weights,
decreased liver weight in male pups,
marbled liver, air filled stomach
-- Study # 870.4100b. Chronic toxicity in dogs NOAEL = 35.9 mg/kg/day
in males and 37.1 mg/kg/day in females. LOAEL = 183 mg/kg/day
in males and 187 mg/kg/day in females based upon body
weight gain depression and increased N-demethylase levels
in both sexes, decreased T4 levels and marginally increased
liver weight in females.
-- Study # 870.3150. 28-Day oral toxicity in nonrodents (dogs)
NOAEL = 164 mg/kg/day in males and 171 mg/kg/day in females. LOAEL
= 1,614 mg/kg/day in males and 1,319 mg/kg/day in females based
on decreased body weight gain, decreased
food consumption, decreased T4 levels and increased thyroxine-binding
capacity, induction of microsomal enzymes, increased
liver weight and liver histopathology in both sexes.
Ref: US EPA Pesticide Fact Sheet for Flucarbazone-sodium.
September 29, 2000.
http://www.epa.gov/opprd001/factsheets/flucarbazone.pdf
Stomach
(click on for all fluorinated
pesticides)
SUBCHRONIC/CHRONIC
TOXICITY
-- Study # 870.3150. 90-Day oral toxicity in nonrodents (dogs)
NOAEL = 33.8 mg/kg/day in males and 35.2 mg/kg/day in females
with the occurrence of slight, adaptive induction of hepatic microsomal
enzymes. LOAEL = 162 mg/kg/day in males and 170 mg/kg/day in females
based on decreased T4 levels, increased thyroxine-binding capacity,
induction of microsomal enzymes, gross pathology
and histopathology in the stomach, and histopathology in
the liver in both sexes.
-- Study # 870.3800. Reproduction and fertility effects in rats
Parental/Systemic NOAEL = 287 mg/kg/day for males and 340 mg/kg/day
for females with a slight, increased incidence of moderate cecal
enlargement occurring as an adaptive response to treatment. LOAEL
= 800 mg/kg/day for males based decreased
liver weight and 991 mg/kg/day for females based on decreased
uterine weight and increased incidence of severe cecal enlargement.
Reproductive/Offspring NOAEL = 287 mg/kg/day for males and 340
mg/kg/day for females LOAEL
= 800 mg/kg/day for males and 991 mg/kg/day for females based
on reduced pup weights, decreased liver
weight in male pups, marbled liver, air
filled stomach
-- Study # 870.4300. 2-Year Chronic toxicity/carcinogenicity in
rats NOAEL = 125 mg/kg/day in males and females LOAEL = 1,000
mg/kg/day in males and females based on
decreased body weight and increased food
consumption in females,
thickened
mucosa of the glandular stomach
in both sexes, inflammatory infiltrates (males), vacuolation
of the squamous epithelium in the fore-stomach (females)
and immunological effects in males. no
evidence of carcinogenicity
Ref: US EPA Pesticide Fact Sheet for Flucarbazone-sodium.
September 29, 2000.
http://www.epa.gov/opprd001/factsheets/flucarbazone.pdf
Environmental
(click
on for all fluorinated pesticides)
Potential
to Contaminate Drinking Water.
Because of the high solubility and mobility of flucarbazone-sodium
and the high mobility and persistence of its sulfonamide
and sulfonic acid degradates, both
surface and ground water contamination are likely to occur.
Aquatic:
Flucarbazone-sodium is practically non-toxic to freshwater
fish on an acute basis (96- hour LC50 > 96.7 ppm).
With chronic exposure, flucarbazone-sodium reduces fish
growth at 2.75 ppm, with a No Observable Adverse Effects
Concentration (NOAEC) established at 1.25 ppm (1250 ppb).
It is practically non-toxic to freshwater invertebrates
on an acute basis (EC50 > 109 ppm) and does not reduce reproduction
of aquatic invertebrates at the NOAEC of 115 ppm (115,000
ppb). The NOAECs for fish and aquatic invertebrates are
well above the peak estimated environmental concentration
(EEC) in water of 1.42 ppb.
Use,
Formulation, Manufacturing Process or Geographic Restrictions
Restrictions
for Use on Wheat:
1.
Do not apply by air.
2. Do not apply through any type of
irrigation system.
3. Do not mix, load or clean spray
equipment within 33 feet of well-heads or aquatic systems,
including marshes, ponds, ditches, streams, lakes, etc.
4. Do not apply within 50 feet of
well-heads or aquatic systems.
5. Do not apply when rain is expected
within the next hour.
6. Make only one application per growing season at a maximum
rate of 0.61 ou
nces of product per acre (0.027 pounds of the active ingredient,
flucarbazone-sodium). 7. Observe a minimum interval to harvest
of 60 days after treatment, after which wheat grain and
straw from treated fields may be fed to livestock.
SUMMARY
OF DATA GAPS
--Toxicology
(28-day rat inhalation study)
-- Residue Chemistry (Revised plant enforcement method which
measures all residues of concern and additional field trial
and processing data on metabolites of concern in wheat commodities;
additional storage stability data on turnip tops and kale)
-- Ecotoxicity (Seedling emergence and vegetative vigor
testing of metabolites)
-- Environmental Fate (Field dissipation
data and an aerobic aquatic metabolism study)
Ref:
US EPA Pesticide Fact Sheet for Flucarbazone-sodium. September
29, 2000. http://www.epa.gov/opprd001/factsheets/flucarbazone.pdf
|
A
February 14, 2005, check at the Code
of Federal Regulations for Flucarbazone-sodium (and
its N-desmethyl metabolite): this herbicide is permitted
in or on
20 food commodities
in the United States. The
following list identifies these crops for which EPA has
set pesticide tolerances.
|
[Code
of Federal Regulations]
[Title 40, Volume 22]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR180.562]
[Page 504-505]
TITLE 40--PROTECTION OF ENVIRONMENT
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
PART 180_TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE
CHEMICALS
IN FOOD--Table of Contents
Subpart C_Specific Tolerances
Sec. 180.562 Flucarbazone-sodium; tolerances for residues.
(a) General. (1) Time-limited tolerances
are established for
combined residues of the herbicide flucarbazone-sodium,
4,5-dihydro-3-
methoxy-4-methyl-5-oxo-N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-
1,2,4-triazole 1-carboxamide, sodium salt) and
its N-desmethyl
metabolite in or on the following food commodities: |
Commodity |
As
of
October 2,
2003
PPM |
As
of
February 14,
2005
PPM |
Expiration/
Revocation Date |
Wheat,
forage |
0.30 |
0.30 |
11/01/05
|
Wheat,
grain |
0.01 |
0.01 |
11/01/05
|
Wheat,
hay |
0.10 |
0.10
|
11/01/05
|
Wheat,
straw |
0.05 |
0.05 |
11/01/05
|
(2)
Time-limited tolerances are established
for combined residues of
the herbicide flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-
N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole
1-
carboxamide, sodium salt) and its metabolites
converted to 2-
(trifluoromethoxy)benzene sulfonamide and calculated
as flucarbazone-
sodium in or on the following food commodities:
[[Page 505]] |
Cattle,
liver |
1.50 |
1.50 |
11/01/05
|
Cattle,
meat |
0.01 |
0.01 |
11/01/05
|
Cattle,
meat byproducts except liver |
0.01 |
0.01 |
11/01/05
|
Goat,
liver |
1.50 |
1.50 |
11/01/05
|
Goat,
meat |
0.01 |
0.01 |
11/01/05
|
Goat,
meat byproducts except liver |
0.01 |
0.01 |
11/01/05
|
Hog,
liver |
1.50 |
1.50 |
11/01/05 |
Hog,
meat |
0.01 |
0.01 |
11/01/05
|
Hog,
meat byproducts except liver |
0.01 |
0.01 |
11/01/05
|
Horse,
liver |
1.50 |
1.50 |
11/01/05
|
Horse,
meat |
0.01 |
0.01 |
11/01/05 |
Horse,
meat byproducts except liver |
0.01 |
0.01 |
11/01/05
|
Milk |
0.005 |
0.005 |
11/01/05
|
Sheep,
liver |
1.50 |
1.50 |
11/01/05
|
Sheep,
meat |
0.01 |
0.01 |
11/01/05 |
Sheep,
meat byproducts except liver |
0.01 |
0.01 |
11/01/05 |
(b)
Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved] |
|