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Index Page
Abstracts
Activity:
Herbicide
(pyridine)
Structure:
Adverse
Effects:
Ataxia
Body
Weight Decrease
Bone
Endocrine: Adrenal
Endocrine: Testicular
Kidney
Mesenteric Lymph Node
Environmental
As
of February 5, 2005, Fluroxypyr, a metabolite
of Fluroxypyr
1-Methylheptyl ester, is
permitted in or on 54
food commodities in the United States -
- see list at bottom of page.
As
to the following Table, we assume "Fluroxypyr" refers
also to Fluroxypyr
1-Methylheptyl ester.
Fluroxypyr
ranked number 9 for "Most
Widely used pesticides in the UK (by Area Treated)"
Rank
|
Formulation |
Method |
Area
treated (ha) |
Weight
applied (kg ai) |
9 |
Fluroxypyr |
Spray |
842,392 |
104,821 |
Ref:
April 29, 2000. UK Department for Environment, Food
& Rural Affairs in the online report, "Design
of a Tax or Charge Scheme for Pesticides. " Annex
C3: Overview of Pesticide Industry
http://www.fluorideaction.org/pesticides/pesticides.ranks.uk.2000.htm
|
|
Ataxia
(click on for all fluorinated pesticides)
A 28-day feeding study
in Beagle dogs administered Fluroxypyr 98.0% a.i. in the diet
at levels of 0, 50, 150 or 450 mg/kg/day for 28 days. Dogs at
500 mg/kg/day exhibited ataxia and
hind limb weakness as well as decreases in body weight and food
consumption and were sacrificed on days 16/17 of the study. Histopathology
showed moderate acute tubular nephrosis and a slight to moderate
acute gastroenteritis. Some early signs of acute tubular nephrosis
were also seen in both sexes of dogs at 150 mg/kg/day. The NOAEL
for the study was 50 mg/kg/ day, the LOEL was 150 mg/kg/day based
on histopathological lesions in the kidneys, decreased testes
weights, and increased adrenal weights in both sexes.
Ref: Federal Register: September 30, 1998.
Fluroxypyr; Pesticide Tolerance. Final Rule.
http://www.fluoridealert.org/pesticides/Fluroxypyr.FR.Sept.30.1998.htm
Body
Weight Decrease (click
on for all fluorinated pesticides)
-- In a range finding
feeding study in dogs, dogs at 500 mg/kg/day exhibited ataxia
and hind limb weakness as well as decreases
in body weight and food consumption.
Histopathology showed moderate acute tubular
nephrosis and a slight to moderate acute gastroenteritis. Some
early signs of acute tubular nephrosis were also seen in both
sexes of dogs at 150 mg/kg/day. The NOEL for the study was 50
mg/kg/day, the LOAEL was 150 mg/kg/day based on histopathological
lesions in the kidneys, decreased testes weights, and increased
adrenal weights in both sexes.
-- In a developmental toxicity study in rats, fluroxypyr administration
resulted in 8 deaths at the high-dose level, and decreased
body-weight gain and food consumption
during the dosing period at this dose level also. Clinical
signs observed in those dying on test included staining of the
skin/fur in the ano-genital area, lethargy, hypothermia, labored
breathing, irregular gait, pale appearance. There were no treatment-related
effects on gross pathologic alterations or absolute and relative
liver and kidney weights at any dose level. The maternal NOEL
is 300 mg/kg/day, the LOAEL is 600 mg/kg/day, based on deaths
and decreased body-weight gain and
food consumption. The
developmental toxicity NOEL is 300 mg/kg/day, and the LOAEL is
600 mg/kg/day, based on an increase in two ossification variations
(incompletely ossified cervical vertebral transverse processes
and pubes).
Ref: US
EPA. Pesticide Fact Sheet. Fluroxypyr. Reason for Issuance: Conditional
Registration Date Issued: September 30, 1998.
http://www.epa.gov/opprd001/factsheets/fluroxypyr.pdf
Bone
(click
on for all fluorinated pesticides)
The developmental NOAEL
is 250 mg/kg/day, the LOEL is 500 mg/kg/day based on
reduced ossification... The
developmental toxicity NOAEL is 300 mg/kg/day, and the LOEL is
600 mg/ kg/day, based on an increase in two ossification
variations incompletely ossified cervical
vertebral transverse processes and pubes.
Ref: Federal
Register. September 30, 1998. Fluroxypyr; Pesticide Tolerance.
Final Rule.
http://www.fluoridealert.org/pesticides/Fluroxypyr.FR.Sept.30.1998.htm
Endocrine:
Adrenal
(click
on for all fluorinated pesticides)
-- Chronic toxicity.
EPA has established the RfD for fluroxypyr at 0.5 mg/kg/day. This
RfD is based on histopathological lesions in the kidneys, decreased
testes weights, and increased adrenal
weights in both sexes observed in a 4-week range-finding
feeding study in the dog with a NOAEL of 50 mg/kg/day. An uncertainty
factor of 100 was used in calculating the RfD to account for both
inter- and intra-species variations.
-- A 90-day feeding study in Wistar rats (10/sex/group) administered
fluroxypyr (98.5% a.i.) in the diet at 0, 80, 750, 1,000 or 1,500
milligrams/kilogram/day (mg/kg/day) for 13 weeks. Significant
nephrotoxicity and deaths were observed at 1,000 and 1,500 mg/kg/day
in both sexes, and in males at 750 mg/kg/day. Death was due to
renal papillary necrosis. Also observed were signs of ill health,
emaciation, decreased food intake, increased kidney weight, histopathological
lesions and decreased renal function. Histological changes were
observed in the adrenals in both
sexes at 1,000 and 1,500 mg/kg/day. In males the NOAEL for this
study is 80 mg/kg/day, and the LOEL is 750 mg/ kg/day based on
kidney effects and death. In females the NOAEL is 750 mg/kg/day,
with the LOEL at 1,000 mg/kg/day based on kidney effects and death.
-- A 28-day feeding study in Beagle dogs administered Fluroxypyr
98.0% a.i. in the diet at levels of 0, 50, 150 or 450 mg/kg/day
for 28 days. Dogs at 500 mg/kg/day exhibited ataxia and hind limb
weakness as well as decreases in body weight and food consumption
and were sacrificed on days 16/17 of the study. Histopathology
showed moderate acute tubular nephrosis and a slight to moderate
acute gastroenteritis. Some early signs of acute tubular nephrosis
were also seen in both sexes of dogs at 150 mg/kg/day. The NOAEL
for the study was 50 mg/kg/ day, the LOEL was 150 mg/kg/day based
on histopathological lesions in the kidneys,
decreased testes weights, and increased
adrenal weights in both sexes.
Ref: Federal Register: September 30, 1998.
Fluroxypyr; Pesticide Tolerance. Final Rule.
http://www.fluoridealert.org/pesticides/Fluroxypyr.FR.Sept.30.1998.htm
Endocrine:
Testicular (click
on for all fluorinated pesticides)
-- Chronic toxicity.
EPA has established the RfD for fluroxypyr at 0.5 mg/kg/day. This
RfD is based on histopathological lesions in the kidneys, decreased
testes weights, and increased adrenal
weights in both sexes observed in a 4-week range-finding
feeding study in the dog with a NOAEL of 50 mg/kg/day. An uncertainty
factor of 100 was used in calculating the RfD to account for both
inter- and intra-species variations.
-- A 28-day feeding study in Beagle dogs administered Fluroxypyr
98.0% a.i. in the diet at levels of 0, 50, 150 or 450 mg/kg/day
for 28 days. Dogs at 500 mg/kg/day exhibited ataxia and hind limb
weakness as well as decreases in body weight and food consumption
and were sacrificed on days 16/17 of the study. Histopathology
showed moderate acute tubular nephrosis and a slight to moderate
acute gastroenteritis. Some early signs of acute tubular nephrosis
were also seen in both sexes of dogs at 150 mg/kg/day. The NOAEL
for the study was 50 mg/kg/ day, the LOEL was 150 mg/kg/day based
on histopathological lesions in the kidneys, decreased
testes weights, and increased adrenal
weights in both sexes.
Ref: Federal Register: September 30, 1998.
Fluroxypyr; Pesticide Tolerance. Final Rule.
http://www.fluoridealert.org/pesticides/Fluroxypyr.FR.Sept.30.1998.htm
Kidney
(click
on for all fluorinated pesticides)
-- Chronic toxicity.
EPA has established the RfD for fluroxypyr at 0.5 mg/kg/day. This
RfD is based on histopathological lesions in the kidneys,
decreased testes weights, and increased
adrenal weights in both sexes observed in a 4-week range-finding
feeding study in the dog with a NOAEL of 50 mg/kg/day. An uncertainty
factor of 100 was used in calculating the RfD to account for both
inter- and intra-species variations.
Ref: Federal Register: September 30, 1998.
Fluroxypyr; Pesticide Tolerance. Final Rule.
http://www.fluoridealert.org/pesticides/Fluroxypyr.FR.Sept.30.1998.htm
-- In a range finding feeding study in dogs, dogs at 500 mg/kg/day
exhibited ataxia and hind limb weakness as well as
decreases in body weight and food consumption. Histopathology
showed moderate acute tubular nephrosis
and a slight to moderate acute gastroenteritis. Some early signs
of acute tubular nephrosis were also
seen in both sexes of dogs at 150 mg/kg/day. The NOEL for the
study was 50 mg/kg/day, the LOAEL was 150 mg/kg/day based on histopathological
lesions in the kidneys, decreased testes weights, and increased
adrenal weights in both sexes.
-- In the carcinogenicity study in mice, there were no adverse
effects on survival or clinical signs in either sex. There was
no apparent treatment-related increase in the incidence of any
tumor type in either sex. The LOAEL is 1000 mg/kg/day, based on
decreased body weight/gain in males and an increased
incidence of kidney lesions in females. The NOEL is 300
mg/kg/day.
-- In a developmental toxicity study in rats, fluroxypyr administration
resulted in 8 deaths at the high-dose level, and
decreased body-weight gain and food consumption during the dosing
period at this dose level also. Clinical signs observed in those
dying on test included staining of the skin/fur in the ano-genital
area, lethargy, hypothermia, labored breathing, irregular gait,
pale appearance. There were no treatment-related effects on gross
pathologic alterations or absolute and relative liver and kidney
weights at any dose level. The maternal NOEL is 300 mg/kg/day,
the LOAEL is 600 mg/kg/day, based on deaths and decreased body-weight
gain and food consumption. The developmental toxicity NOEL is
300 mg/kg/day, and the LOAEL is 600 mg/kg/day, based on an increase
in two ossification variations (incompletely ossified cervical
vertebral transverse processes and pubes).
Ref: US EPA. Pesticide Fact Sheet. Fluroxypyr.
Reason for Issuance: Conditional Registration Date Issued: September
30, 1998.
http://www.epa.gov/opprd001/factsheets/fluroxypyr.pdf
870.4300 Carcinogenicity--Rats
NOAEL = 100 mg/kg/day. LOAEL = 500 mg/kg/day based on chronic
progressive kidney glomerulonephropathy (M&F).(no)
evidence of carcinogenicity.
Ref:
Federal Register. December 31, 2003. Fluroxypyr; Pesticide Tolerance.
Final Rule.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/December/Day-31/p32007.htm
Mesenteric
Lymph Node (click
on for all fluorinated pesticides)
In the combined chronic toxicity/carcinogenicity study in rats,
fluroxypyr 99.0% a.i. was administered to 50 Fischer 344 rats/sex/dose
via the diet at dose levels of 0, 100, 500, and 1,000, females
only,
mg/kg/day for 24 months 10 rats/sex/dose for 12 months. There
was no apparent increase in the incidence of kidney tumors in
either sex. With the exception of an increased incidence of parafollicular
cell adenomas, single only, in males at 500 mg/kg/day, at the
doses tested, there was no apparent treatment-related increase
in any tumor type in either sex. The LOEL is 500 mg/kg/day, based
on increased kidney weight in both sexes, increased incidence
of atrophy, adipose tissue mesenteric tissues
in males and an increase in the severity of chronic progressive
glomerulonephropathy in the kidney in both sexes. The NOAEL is
100 mg/kg/day. Deaths occurred at 1,000 mg/kg/day in males within
the first 90 days on test 2 by day 28 and 3 more by day 56.
Ref: Federal Register. Fluroxypyr (Dow Agro).
September 30, 1998. Pesticide Tolerance. Final Rule.
http://www.fluoridealert.org/pesticides/fluroxypyr.fr.sept.30.1998.htm
Environmental
(click
on for all fluorinated pesticides)
--
The data available at this time indicate that fluroxypyr
is highly phytotoxic.
-- Aquatic - Estuarine/Marine Fluroxypyr is slightly toxic
to the silverside (96-hour LC 50 = 40 mg/L). Fluroxypyr
acid is highly toxic to the eastern oyster (96-hour
LC 50 /EC 50 = 0.068 mg/L); fluroxypyr 1-methylheptyl ester
is slightly toxic to the eastern oyster (96-hour LC 50 /EC
50 = 51 mg/L). It is practically non-toxic to the grass
shrimp (96-hour LC 50 /EC 50 > 120 mg/L). Fluroxypyr
is highly toxic terrestrial plants. Seedling emergence
studies identified the most sensitive species to fluroxypyr
methylheptyl ester being the cucumber (EC 25 = 0.075 pounds
active ingredient/acre). Since fluroxypyr methylheptyl ester
may degrade to fluroxypyr acid before reaching non-target
plants, seedling emergence studies were performed on fluroxypyr
acid and identified cotton as the most sensitive species
(EC 25 = 0.025 pounds active ingredient/acre). Vegetative
vigor studies with fluroxypyr methlyheptyl ester also identified
cotton as the most sensitive species (EC 25 = 0.0012 pounds
active ingredient/acre).
Ref: US EPA. Pesticide Fact
Sheet. Fluroxypyr. Reason for Issuance: Conditional Registration
Date Issued: September 30, 1998.
http://www.epa.gov/opprd001/factsheets/fluroxypyr.pdf
|
A
February 5, 2005, check at the Code
of Federal Regulations for Fluroxypyr 1-Methylheptyl ester
and its metabolite Fluroxypyr: they are permitted
in or on 54
food commodities in the United
States. The
following list identifies these commodities 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: 40CFR180.535]
[Page 494-495]
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. 180.535 Fluroxypyr 1-methylheptyl ester; tolerances for
residues.
(a) General. Tolerances are established for
combined residues of
fluroxypyr 1-methylheptyl ester [1-methylheptyl ((4-amino-3,5-dichloro-
6-fluoro-2-pyridinyl)oxy)acetate] and
its metabolite fluroxypyr [((4-
amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] in
or on the
following raw agricultural commodities. |
Commodity |
Parts
per Million
PPM |
US
Code of Federal Regulations
CFR |
Barley,
grain |
0.5 |
180.535
|
Barley,
forage |
12.0 |
180.535
|
Barley,
hay |
20.0 |
180.535
|
Barley,
straw |
12.0 |
180.535
|
Cattle,
fat |
0.1 |
180.535
|
Cattle,
kidney |
1.5 |
180.535
|
Cattle,
meat |
0.1 |
180.535
|
Cattle,
meat byproducts |
0.1 |
180.535
|
Corn,
field, forage |
1.0 |
180.535
|
Corn,
field, grain |
0.02 |
180.535
|
Corn,
field, stover |
0.5 |
180.535
|
Corn,
sweet, forage |
1.0 |
180.535
|
Corn,
sweet, kernel plus cob with husks removed |
0.02 |
180.535
|
Corn,
sweet, stover |
2.0 |
180.535
|
Goat,
fat |
0.1 |
180.535
|
Goat,
kidney |
1.5 |
180.535
|
Goat,
meat |
0.1 |
180.535
|
Goat,
meat byproducts |
0.1 |
180.535
|
Grain,
aspirated fractions |
0.6 |
180.535
|
Grass,
forage |
120 |
180.535
|
Grass,
hay |
160 |
180.535
|
Hog,
fat |
0.1 |
180.535
|
Hog,
kidney |
1.5 |
180.535
|
Hog,
meat |
0.1 |
180.535
|
Hog,
meat byproducts |
0.1 |
180.535
|
Horse,
fat |
0.1 |
180.535
|
Horse,
kidney |
1.5 |
180.535
|
Horse,
meat |
0.1 |
180.535
|
Horse,
meat byproducts |
0.1 |
180.535
|
Milk |
0.3 |
180.535
|
Oat,
forage |
12.0 |
180.535
|
Oat,
grain |
0.5 |
180.535
|
Oat,
hay |
20.0 |
180.535
|
Oat,
straw |
12.0 |
180.535
|
Sheep,
fat |
0.1 |
180.535
|
Sheep,
kidney |
1.5 |
180.535
|
Sheep,
meat |
0.1 |
180.535
|
Sheep,
meat byproducts |
0.1 |
180.535
|
Sorghum,
grain, forage |
2.0 |
180.535
|
Sorghum,
grain, grain |
0.02 |
180.535
|
Sorghum,
grain, stover |
4.0 |
180.535
|
Wheat,
forage |
12.0 |
180.535
|
Wheat,
grain |
0.5 |
180.535
|
Wheat,
hay |
20.0 |
180.535
|
Wheat,
straw |
12.0 |
180.535
|
(b)
Section 18 emergency exemptions. Time-limited
tolerances are
established for the combined residues
of fluroxypyr 1-methylheptyl ester
and its metabolite fluroxypyr, in connection with use
of the pesticide
under section 18 emergency exemptions granted by EPA. The
tolerances
will expire and are revoked on the dates specified in the
following table. |
Commodity |
PPM |
Expiration/Revocation
Date |
Corn, field,
forage |
2.0
|
12/31/06 |
Corn, field,
grain |
0.05
|
12/31/06 |
Corn, field,
stover |
2.5
|
12/31/06 |
Corn, sweet,
forage |
2.0
|
12/31/06 |
Corn, sweet,
kernel plus cob with husks removed |
0.05
|
12/31/06 |
Corn, sweet,
stover |
2.5
|
12/31/06 |
Onion |
0.02 |
6/30/07 |
Sorghum,
grain, forage |
2.0
|
12/31/05 |
Sorghum,
grain, grain |
0.035 |
12/31/05 |
Sorghum,
grain, stover |
4.0 |
12/31/05 |
Cattle,
kidney |
1.5 |
12/31/04 |
Goat,
kidney |
1.5 |
12/31/04 |
Grass,
forage |
120 |
12/31/04 |
Grass,
hay |
160 |
12/31/04 |
Hog,
kidney |
1.5 |
12/31/04 |
Horse,
kidney |
1.5 |
12/31/04 |
Milk |
0.30 |
12/31/04 |
Sheep,
kidney |
1.5 |
12/31/04 |
(c)
Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved] |
|