Adverse Effects
Trifloxystrobin
CAS No.
141517-21-7
 
 

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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

As of February 16, 2005, this fungicide is permitted in or on 262 food commodities in the United States - see list at
http://www.fluorideaction.org/pesticides/mrls.trifloxystrobin.htm


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 trifloxystrobin Groundwater 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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