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Activity: Fungicide
(Strobin)
Structure:
Adverse Effects:
Body
Weight Decrease
Bone
Endocrine: Pituitary
Endocrine: Thymus
Eye
Kidney
Liver
Mesenteric Lymph Node
Pancreas
Spleen
Environmental
Body
Weight Decrease
(click
on for all fluorinated pesticides)
-- 2-generation reproduction study-Rat LOAEL = 55.3 mg/kg/day,
based upon decreases in body
weight, body weight gains, reduced food consumption and
histopathological lesions in the liver, kidneys and spleen
-- 2-Generation reproduction study-Rat LOAEL = 55.3 mg/kg/day,
based upon reduced pup body weights
during lactation
Ref: Federal Register: September 10, 2003
(Volume 68, Number 175). Trifloxystrobin; Pesticide Tolerance.
Final Rule.
http://www.fluorideaction.org/pesticides/trifloxystrobin.fr.sept.03.htm
-- Chronic toxicity.
The liver appears to be the major
primary target organ based on the chronic studies conducted in
mice, rats, and dogs. It was identified as a target organ in both
the mouse and the dog studies with trifloxystrobin. However, no
liver effect was seen in the chronic rat study which produced
the lowest NOAEL of 2.5 mg/kg based on reduced
body weight gain and food consumption seen
at higher dose levels.
Ref: Federal Register. November 14, 2001.
[PF-1048; FRL-6806-6]
http://www.fluoridealert.org/pesticides/Trifloxystrobin.FR.Nov14.01.htm
Bone
(click
on for all fluorinated pesticides)
Subchronic
toxicity. In
subchronic studies, several mortality related changes were reported
for the top dose in dogs (500 mg/kg)
and rats (800 mg/kg). At these dose
levels, excessive toxicity has resulted in body weight loss and
mortality with the associated and non-specific changes in several
organs (such as atrophy in the thymus, pancreas, bone
marrow,
lymph node, and spleen) which are not considered specific target
organs for the test compound... In the rabbit teratology study,
body weight loss and dramatically reduced food consumption were
observed in the dam at 250 mg/ kg. No teratogenic effects or any
other effects were seen on pregnancy or fetal parameters except
for the increase in skeletal anomaly of
fused sternebrae-3 and sternebrae-4
at the top dose level of 500 mg/kg. This finding is regarded as
a marginal effect on skeletal development
that could have resulted from the 40-65% lower food intake during
treatment at this dose level. The developmental NOAEL was 250
mg/kg.
Ref: Federal Register. November 14, 2001.
[PF-1048; FRL-6806-6]
http://www.fluoridealert.org/pesticides/Trifloxystrobin.FR.Nov14.01.htm
Reproductive toxicity Target
/ critical effect - Reproduction: Decreased bodyweight
gain of pups and delayed eye opening at parental toxic doses.
Lowest relevant reproductive NOAEL / NOEL: 50 ppm(2.3 mg/kg bw/day).
Target / critical effect - Developmental toxicity: Enlarged thymus
(rat) and skeletal effects (rabbit)
at maternally toxic dose levels. Lowest relevant developmental
NOAEL / NOEL: 50 mg/kg bw/day (rabbit)
Ref: Review report for the active substance
trifloxystrobin. Trifloxystrobin. SANCO/4339/2000-Final. 7 April
2003. Finalised in the [European Commission] Standing Committee
on the Food Chain and Animal Health at its meeting on 15 April
2003 in view of the inclusion of trifloxystrobin in Annex I of
Directive 91/414/EEC.
http://www.fluorideaction.org/pesticides/trifloxystrobin.eu.april.03.pdf
Endocrine:
Pituitary (click
on for all fluorinated pesticides)
In the rat chronic/carcinogenicity study, the NOAEL of 11.0 mg/kg
bw/day was set based on the reduction in body-weight gain in both
sexes, decreased food consumption and slightly
increased incidence of developmental cyst in pituitary gland and
angiomatous hyperplasia of the mesenteric
node in males. An effect on the liver (increased relative
weight) was seen only in females at the highest dose level of
73 mg/kg bw/day.
Ref: January 30, 2004 - Regulatory
Note REG2004-03. Canada Pest Management Regulatory Agency.
Also available at:
http://www.hc-sc.gc.ca/pmra-arla/english/pdf/reg/reg2004-03-e.pdf
Endocrine:
Thymus
(click
on for all fluorinated pesticides)
Reproductive toxicity.
Target / critical effect - Developmental toxicity: Enlarged
thymus (rat) and skeletal effects (rabbit) at maternally
toxic dose levels. Lowest relevant developmental NOAEL / NOEL:
50 mg/kg bw/day (rabbit)
Ref: Review report for the active substance
trifloxystrobin. Trifloxystrobin. SANCO/4339/2000-Final. 7 April
2003. Finalised in the [European Commission] Standing Committee
on the Food Chain and Animal Health at its meeting on 15 April
2003 in view of the inclusion of trifloxystrobin in Annex I of
Directive 91/414/EEC.
http://www.fluorideaction.org/pesticides/trifloxystrobin.eu.april.03.pdf
Subchronic
toxicity. In
subchronic studies, several mortality related changes were reported
for the top dose in dogs (500 mg/kg) and rats (800 mg/kg). At
these dose levels, excessive toxicity has resulted in body weight
loss and mortality with the associated and non-specific changes
in several organs (such as atrophy in the
thymus, pancreas, bone marrow, lymph node, and spleen)
which are not considered specific target organs for the test compound.
Ref: Federal Register: November 14, 2001
[Page 57074-57079]. Notice of Filing a Pesticide Petition to Establish
a Tolerance for a Certain Pesticide Chemical in or on Food.
http://www.fluoridealert.org/pesticides/Trifloxystrobin.FR.Nov14.01.htm
Eye
(click
on for all fluorinated pesticides)
-- Reproductive toxicity. Target
/ critical effect - Reproduction: Decreased bodyweight
gain of pups and delayed eye opening at
parental toxic doses. Lowest relevant reproductive NOAEL
/ NOEL: 50 ppm(2.3 mg/kg bw/day)...
-- Medical data New active substance.
Limited data. Some evidence of skin and
eye irritation in 3 people during field trials (but 120
people without effects).
Ref: Review report for the active substance
trifloxystrobin. Trifloxystrobin. SANCO/4339/2000-Final. 7 April
2003. Finalised in the [European Commission] Standing Committee
on the Food Chain and Animal Health at its meeting on 15 April
2003 in view of the inclusion of trifloxystrobin in Annex I of
Directive 91/414/EEC.
http://www.fluorideaction.org/pesticides/trifloxystrobin.eu.april.03.pdf
Kidney
(click
on for all fluorinated pesticides)
-- Short term toxicity. Target
/ critical effect: Decreased bodyweight & food consumption.
Liver: increased weight, hepatocellular hypertrophy and necrosis.
Kidney: increased weight and acute tubular
lesions. Pancreas: atrophy. Lowest relevant oral NOAEL
/ NOEL: 90-day rat: 100 ppm (6.4 mg/kg bw/day) Lowest relevant
dermal NOAEL / NOEL: 28-day rat: 100 mg/kg bw/day Lowest relevant
inhalation NOAEL / NOEL: No study - not required
-- Long term toxicity and carcinogenicity.
Target / critical effect: Decreased
bodyweight & food consumption. Liver: increased weight, hepatocellular
hypertrophy, fatty change and necrosis. Kidney:
increased weight. Lowest relevant NOAEL: 2-yr rat: 250
ppm (9.8 mg/kg bw/day) Carcinogenicity: No carcinogenic potential
Ref: Review report for the active substance
trifloxystrobin. Trifloxystrobin. SANCO/4339/2000-Final. 7 April
2003. Finalised in the [European Commission] Standing Committee
on the Food Chain and Animal Health at its meeting on 15 April
2003 in view of the inclusion of trifloxystrobin in Annex I of
Directive 91/414/EEC.
http://www.fluorideaction.org/pesticides/trifloxystrobin.eu.april.03.pdf
Liver
(click
on for all fluorinated pesticides)
-- Subchronic toxicity.
In subchronic studies, several mortality related changes were
reported for the top dose in dogs (500 mg/kg) and rats (800 mg/kg).
At these dose levels, excessive toxicity has resulted in body
weight loss and mortality with the associated and non-specific
changes in several organs (such as atrophy in the thymus, pancreas,
bone marrow, lymph node, and spleen) which are not considered
specific target organs for the test compound. In the dog, specific
effects were limited to hepatocellular hypertrophy
at 150 mg/kg and hyperplasia of the epithelium of the gall bladder
at 500 mg/kg. Target organ effects in the rat were noted as
hepatocellular hypertrophy (200 mg/kg) and the related
liver weight increase (50 mg/kg).
In the mouse, target organ effects included single cell necrosis
(300 mg/kg) and hypertrophy (1,050
mg/ kg) in the liver and extramedullary
hematopoiesis (300 mg/ kg) and hemosiderosis in the spleen (1,050
mg/kg). In general, definitive target organ toxicity, mostly in
the liver, was seen at high feeding
levels of over 100 mg/kg for an extended treatment period. At
the lowest observed adverse effect level (LOAEL), no serious toxicity
was observed other than mostly non-specific effects including
a reduction in body weight and food consumption or liver
hypertrophy.
-- Chronic toxicity. The liver appears
to be the major primary target organ based on the chronic studies
conducted in mice, rats, and dogs. It was identified as a target
organ in both the mouse and the dog studies with trifloxystrobin.
However, no liver effect was seen
in the chronic rat study which produced the lowest NOAEL of 2.5
mg/kg based on reduced body weight gain and food consumption seen
at higher dose levels.
Ref: Federal Register. November 14, 2001.
[PF-1048; FRL-6806-6]
http://www.fluoridealert.org/pesticides/Trifloxystrobin.FR.Nov14.01.htm
-- Other toxicological studies.
Investigations into replicative DNA synthesis: No evidence of
replicative DNA synthesis in rat or mouse heptocytes following
3-months administration in diet. Investigations
into mitochondrial function: In vitro studies
in isolated rat liver mitochondria indicated trifloxystrobin
caused a significant concentration dependant inhibition of mitochondrial
respiration....
Ref: Review report for the active substance
trifloxystrobin. Trifloxystrobin. SANCO/4339/2000-Final. 7 April
2003. Finalised in the [European Commission] Standing Committee
on the Food Chain and Animal Health at its meeting on 15 April
2003 in view of the inclusion of trifloxystrobin in Annex I of
Directive 91/414/EEC.
http://www.fluorideaction.org/pesticides/trifloxystrobin.eu.april.03.pdf
Mesenteric
Lymph
Node (click
on for all fluorinated pesticides)
In the rat chronic/carcinogenicity study, the NOAEL of 11.0 mg/kg
bw/day was set based on the reduction in body-weight gain in both
sexes, decreased food consumption and slightly increased incidence
of developmental cyst in pituitary gland and angiomatous hyperplasia
of the mesenteric node in males.
An effect on the liver (increased relative weight) was seen only
in females at the highest dose level of 73 mg/kg bw/day.
Ref: January 30, 2004 - Regulatory
Note REG2004-03. Canada Pest Management Regulatory Agency.
Also available at:
http://www.hc-sc.gc.ca/pmra-arla/english/pdf/reg/reg2004-03-e.pdf
Pancreas
(click
on for all fluorinated pesticides)
-- Subchronic
toxicity. In subchronic studies, several mortality related
changes were reported for the top dose in dogs (500 mg/kg) and
rats (800 mg/kg). At these dose levels, excessive toxicity has
resulted in body weight loss and mortality with the associated
and non-specific changes in several organs (such as
atrophy in the thymus, pancreas,
bone marrow, lymph node, and spleen) which are not considered
specific target organs for the test compound. In the dog, specific
effects were limited to hepatocellular hypertrophy
at 150 mg/kg and hyperplasia of the epithelium of the gall bladder
at 500 mg/kg. Target organ effects in the rat were noted as hepatocellular
hypertrophy (200 mg/kg) and the related liver weight increase
(50 mg/kg). In the mouse, target organ effects included single
cell necrosis (300 mg/kg) and hypertrophy (1,050 mg/ kg) in the
liver and extramedullary hematopoiesis (300 mg/ kg) and hemosiderosis
in the spleen (1,050 mg/kg). In general, definitive target organ
toxicity, mostly in the liver, was seen at high feeding levels
of over 100 mg/kg for an extended treatment period. At the lowest
observed adverse effect level (LOAEL), no serious toxicity was
observed other than mostly non-specific effects including a reduction
in body weight and food consumption or liver hypertrophy.
Ref: Federal Register. November 14, 2001.
[PF-1048; FRL-6806-6]
http://www.fluoridealert.org/pesticides/Trifloxystrobin.FR.Nov14.01.htm
Short term toxicity. Target
/ critical effect: Decreased bodyweight & food consumption.
Liver: increased weight, hepatocellular hypertrophy and necrosis.
Kidney: increased weight and acute tubular lesions. Pancreas:
atrophy. Lowest relevant oral NOAEL / NOEL: 90-day rat:
100 ppm (6.4 mg/kg bw/day). Lowest relevant dermal NOAEL / NOEL:
28-day rat: 100 mg/kg bw/day. Lowest relevant inhalation NOAEL
/ NOEL: No study - not required
Ref: Review report for the active substance
trifloxystrobin. Trifloxystrobin. SANCO/4339/2000-Final. 7 April
2003. Finalised in the [European Commission] Standing Committee
on the Food Chain and Animal Health at its meeting on 15 April
2003 in view of the inclusion of trifloxystrobin in Annex I of
Directive 91/414/EEC.
http://www.fluorideaction.org/pesticides/trifloxystrobin.eu.april.03.pdf
Spleen
(click on for all fluorinated pesticides)
4. Subchronic toxicity.
In subchronic studies, several mortality related changes were
reported for the top dose in dogs (500 mg/kg) and rats (800 mg/kg).
At these dose levels, excessive toxicity has resulted in body
weight loss and mortality with the associated and non-specific
changes in several organs (such as atrophy in the thymus, pancreas,
bone marrow, lymph node, and spleen)
which are not considered specific target organs for the test compound.
In the dog, specific effects were limited to hepatocellular hypertrophy
at 150 mg/kg and hyperplasia of the epithelium of the gall bladder
at 500 mg/kg. Target organ effects in the rat were noted as hepatocellular
hypertrophy (200 mg/kg) and the related liver weight increase
(50 mg/kg). In the mouse, target organ effects included single
cell necrosis (300 mg/kg) and hypertrophy (1,050 mg/ kg) in the
liver and extramedullary hematopoiesis (300 mg/ kg) and hemosiderosis
in the spleen (1,050 mg/kg). In general,
definitive target organ toxicity, mostly in the liver, was seen
at high feeding levels of over 100 mg/kg for an extended treatment
period. At the lowest observed adverse effect level (LOAEL), no
serious toxicity was observed other than mostly non-specific effects
including a reduction in body weight and food consumption or liver
hypertrophy. 5. Chronic toxicity. The liver appears to be the
major primary target organ based on the chronic studies conducted
in mice, rats, and dogs. It was identified as a target organ in
both the mouse and the dog studies with trifloxystrobin. However,
no liver effect was seen in the chronic rat study which produced
the lowest NOAEL of 2.5 mg/kg based on reduced body weight gain
and food consumption seen at higher dose levels.
Ref: Federal Register. November 14, 2001.
[PF-1048; FRL-6806-6]
http://www.fluoridealert.org/pesticides/Trifloxystrobin.FR.Nov14.01.htm
Environmental
(click on for all fluorinated
pesticides)
Freshwater
Fish and Invertebrate Acute Toxicity
-- Rainbow trout 0.014 ppm (LC50) very
highly
toxic;
-- Bluegill sunfish 0.054 ppm (LC50)
very
highly toxic;
-- Water flea 0.025 ppm (LC50)
very highly toxic;
Estuarine/Marine Fish and Invertebrate Acute Toxicity Under
Flow-through Condition LC50 or EC50 (ppb):
---- Sheepshead minnow 78 (ppb) very
highly toxic; ---- Mysid shrimp 8.62 (ppb) very
highly toxic;
---- Eastern oyster (shell deposition) 29.3 (ppb) very
highly toxic
Ref: US EPA Pesticide Fact
Sheet. Trifloxystrobin. Reason for Issuance: New Chemical
Registration. Date Issued: September 20, 1999.
http://www.epa.gov/opprd001/factsheets/trifloxystrobin.pdf
...
Trifloxystrobin's major isomer, CGA-321113, forms at the
average rate of 80% of the applied parent,
is persistent, (half life is about 301 days), and
soluble, 30.9 ppm and is also mobile. The major degradate
minimum Koc is 49, the median Koc is 127 and is also stable
to hydrolysis. The major degradate,
CGA-321113 is persistent and mobile and has a potential
to leach into groundwater. CGA-321113 has been found in
the soil profile at the 36 inch depth.
Ref: Federal Register: May
22, 2002 (Volume 67, Number 99)] [Rules and Regulations]
[Page 35915-35924]. Trifloxystrobin; Pesticide Tolerance.
Final Rule.
http://www.fluorideaction.org/pesticides/trifloxystrobin.fr.may22.02.htm
--
Accumulation in water and/or sediment: Trifloxystrobin will
not accumulate. CGA 321113 may accumulate
in sediment (see DT50 above).
-- Remarks: Residue relevant for environmental monitoring
in water: Surface water Ð trifloxystrobin Groundwater Ð
trifloxystrobin. Member states may wish to monitor for NOA
413161 in vulnerable groundwater situations
as it could approach the 10g/l drinking water limit for
chlorinated aliphatic compounds compounds even though it
is considered not relevant.
Ref:
Review report for the active substance trifloxystrobin.
Trifloxystrobin. SANCO/4339/2000-Final. 7 April 2003. Finalised
in the [European Commission] Standing Committee on the Food
Chain and Animal Health at its meeting on 15 April 2003
in view of the inclusion of trifloxystrobin in Annex I of
Directive 91/414/EEC.
http://www.fluorideaction.org/pesticides/trifloxystrobin.eu.april.03.pdf
Summary of the risk to aquatic
organisms: An assessment of the environmental
safety associated with the use of trifloxystrobin and its
associated end-use products has
identified risks to all aquatic species. The
risk was determined to be moderate to high to freshwater
and marine/estuarine invertebrates on an acute and chronic
basis and a high to freshwater
algae on an acute basis. A moderate to high risk
to coldwater fish was determined on an acute and chronic
basis, a low to moderate risk to warmwater fish was determined
on an acute basis and a low to moderate risk was determined
for marine and
estuarine fish on an acute basis. The risk to vascular plants
was determined to be negligible to low... No chronic fish
study conducted with CGA-321113 was submitted. Due
to its persistence and its environmental relevance, a chronic
freshwater fish toxicity study should be conducted with
CGA-321113.
Ref: January 30, 2004
- Regulatory Note
REG2004-03. Canada Pest Management Regulatory Agency.
Also available at: http://www.hc-sc.gc.ca/pmra-arla/english/pdf/reg/reg2004-03-e.pdf
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