Adverse Effects
Prosulfuron
CAS No. 94125-34-5
 
 

Return to Prosulfuron Index Page

Activity: Herbicide (sulfonylurea)
Structure:



Adverse Effects:
Blood
Body Weight Decrease
Bone
Endocrine: Breast
Endocrine: Testicular
Endocrine
: Uterus
Heart
Liver

• Over the years the US EPA has granted temporary pesticide tolerances for resiudes of Prosulfuron on raw agricultural commodities: corn (forage, fodder, grain and fresh [including sweet kernels], milk, and meat, fat and meat by-products, of cattle, goats, hogs, horses, and sheep.

• Syngenta petitioned the US EPA in December 2002 for permanent residue tolerances for these same food groups. See petition in Federal Register at
http://www.fluorideaction.org/pesticides/prosulfuron.fr.dec.31.2002.htm

• See toxicological studies submitted to US EPA by Ciba-Geigy at bottom of page


Blood (click on for all fluorinated pesticides)

-- Short term toxicity Target / critical effect: Liver (hepatocyte hypertrophy), heart (myocardial degeneration), hematopoietic system (red blood cells decreased) Lowest relevant oral NOAEL / NOEL: NOAEL = 6 mg/kg b.w./day (90-day, dog)
Ref: July 2, 2002 - Review report for the active substance prosulfuron. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 26 February 2002 in view of the inclusion of prosulfuron in Annex I of Directive 91/414/EEC.European Commission Health & Consumer Protection Directorate-General.

http://www.fluoridealert.org/pesticides/Prosulfuron.EU.July.2002.pdf

Chronic toxicity. In the 1-year dog chronic dosing study, the NOAEL was 1.84 mg/kg/day based on hematologic and clinical chemistry effects and incidence of lipofuscin accumulation in the liver at 18.6 mg/kg/day.
Ref: Federal Register: December 31, 2002. Prosulfuron; Notice of Filing Pesticide Petitions to Establish Tolerances for a Certain Pesticide Chemical in or on Food.

http://www.fluorideaction.org/pesticides/prosulfuron.fr.dec.31.2002.htm

-- A 2-year chronic feeding/carcinogenicity study in rats fed dosages of 0, 0.4, 7.9, 79.9 or 160.9 (males), and 0, 0.5, 9.2, 95.7 or 205.8 mg/kg/day (females) was conducted. There was uncertain evidence of carcinogenicity with slight increases in the incidence of mammary gland adenocarcinomas in females at 95.7 and 205.8 mg/kg/day, slight increase in incidence of benign testicular interstitial cell tumors at 79.9 and 160.9 mg/kg/day (significant trend only). A systemic NOAEL of 7.9 mg/kg/day was based on decreased body weight and body weight gain, hematopoietic effects (males), and possibly increased serum GGT and decreased liver, kidney and adrenal weights (females) at 79.9 mg/kg/ day.
Ref: Federal Register: August 25, 1999. [PF-882; FRL-6093-7]. Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food.

http://www.fluorideaction.org/pesticides/prosulfuron.fr.aug.25.1999.htm

Body Weight Decrease (click on for all fluorinated pesticides)

-- A 2-year chronic feeding/carcinogenicity study in rats fed dosages of 0, 0.4, 7.9, 79.9 or 160.9 (males), and 0, 0.5, 9.2, 95.7 or 205.8 mg/kg/day (females) was conducted. There was uncertain evidence of carcinogenicity with slight increases in the incidence of mammary gland adenocarcinomas in females at 95.7 and 205.8 mg/kg/day, slight increase in incidence of benign testicular interstitial cell tumors at 79.9 and 160.9 mg/kg/day (significant trend only). A systemic NOAEL of 7.9 mg/kg/day was based on decreased body weight and body weight gain, hematopoietic effects (males), and possibly increased serum GGT and decreased liver, kidney and adrenal weights (females) at 79.9 mg/kg/ day.
Ref: Federal Register: August 25, 1999. [PF-882; FRL-6093-7]. Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food.

http://www.fluorideaction.org/pesticides/prosulfuron.fr.aug.25.1999.htm

Bone (click on for all fluorinated pesticides)

-- Reproductive toxicity. Developmental toxicity: Skeletal variations (rat) and resorptions (rabbit) at maternal toxic doses. Lowest relevant developmental NOAEL / NOEL: NOAEL = 10 mg/kg b.w./day (rabbit)
Ref: July 2, 2002 - Review report for the active substance prosulfuron. European Commission Health & Consumer Protection Directorate-General.

Endocrine: Breast (click on for all fluorinated pesticides)

-- Long term toxicity and carcinogenicity Target / critical effect: Liver (hepatocellular hypertrophy in mice), indication of hormonal disruption (uterus and mammalian gland in rats) at high dose levels. Lowest relevant NOAEL: NOAEL = 1,7 mg/kg bw/day (18-month, mouse) Carcinogenicity: No carcinogenic potential
Ref: July 2, 2002 - Review report for the active substance prosulfuron. European Commission Health & Consumer Protection Directorate-General.

-- A 2-year chronic feeding/carcinogenicity study in rats fed dosages of 0, 0.4, 7.9, 79.9 or 160.9 (males), and 0, 0.5, 9.2, 95.7 or 205.8 mg/kg/day (females) was conducted. There was uncertain evidence of carcinogenicity with slight increases in the incidence of mammary gland adenocarcinomas in females at 95.7 and 205.8 mg/kg/day, slight increase in incidence of benign testicular interstitial cell tumors at 79.9 and 160.9 mg/kg/day (significant trend only). A systemic NOAEL of 7.9 mg/kg/day was based on decreased body weight and body weight gain, hematopoietic effects (males), and possibly increased serum GGT and decreased liver, kidney and adrenal weights (females) at 79.9 mg/kg/ day.
-- Carcinogenicity. The HED RfD/Peer Review Committee (PRC) classified this chemical as a Class D oncogen based on the conclusion that there was uncertain evidence of carcinogenicity. No relevant treatment-related oncogenic potential was observed in rats and mice. The slightly increased incidence of testicular interstitial cell tumors in male rats at 79.9 mg/kg/day and the slightly increased incidence of mammary gland adenocarcinoma in females at 95.7 mg/kg/day was not significant when the increased survival in these groups was considered. Furthermore, the overall incidence of mammary tumors was essentially identical in all groups including the control. There was no evidence of carcinogenicity in mice and dosages in both studies were sufficient for identifying a cancer risk. In the absence of carcinogenicity, it is appropriate that a RfD approach be used for quantitation of human risks.
Ref: Federal Register: August 25, 1999. [PF-882; FRL-6093-7]. Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food.
http://www.fluorideaction.org/pesticides/prosulfuron.fr.aug.25.1999.htm

Endocrine: Testicular (click on for all fluorinated pesticides)

-- A 2-year chronic feeding/carcinogenicity study in rats fed dosages of 0, 0.4, 7.9, 79.9 or 160.9 (males), and 0, 0.5, 9.2, 95.7 or 205.8 mg/kg/day (females) was conducted. There was uncertain evidence of carcinogenicity with slight increases in the incidence of mammary gland adenocarcinomas in females at 95.7 and 205.8 mg/kg/day, slight increase in incidence of benign testicular interstitial cell tumors at 79.9 and 160.9 mg/kg/day (significant trend only). A systemic NOAEL of 7.9 mg/kg/day was based on decreased body weight and body weight gain, hematopoietic effects (males), and possibly increased serum GGT and decreased liver, kidney and adrenal weights (females) at 79.9 mg/kg/ day.
-- Carcinogenicity. The HED RfD/Peer Review Committee (PRC) classified this chemical as a Class D oncogen based on the conclusion that there was uncertain evidence of carcinogenicity. No relevant treatment-related oncogenic potential was observed in rats and mice. The slightly increased incidence of testicular interstitial cell tumors in male rats at 79.9 mg/kg/day and the slightly increased incidence of mammary gland adenocarcinoma in females at 95.7 mg/kg/day was not significant when the increased survival in these groups was considered. Furthermore, the overall incidence of mammary tumors was essentially identical in all groups including the control. There was no evidence of carcinogenicity in mice and dosages in both studies were sufficient for identifying a cancer risk. In the absence of carcinogenicity, it is appropriate that a RfD approach be used for quantitation of human risks.
Ref: Federal Register: August 25, 1999. [PF-882; FRL-6093-7]. Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food.

http://www.fluorideaction.org/pesticides/prosulfuron.fr.aug.25.1999.htm

Endocrine: Uterus (click on for all fluorinated pesticides)

-- Long term toxicity and carcinogenicity Target / critical effect: Liver (hepatocellular hypertrophy in mice), indication of hormonal disruption (uterus and mammalian gland in rats) at high dose levels. Lowest relevant NOAEL: NOAEL = 1,7 mg/kg bw/day (18-month, mouse) Carcinogenicity: No carcinogenic potential
Ref: July 2, 2002 - Review report for the active substance prosulfuron. European Commission Health & Consumer Protection Directorate-General.

Heart (click on for all fluorinated pesticides)

-- Short term toxicity Target / critical effect: Liver (hepatocyte hypertrophy), heart (myocardial degeneration), hematopoietic system (red blood cells decreased) Lowest relevant oral NOAEL / NOEL: NOAEL = 6 mg/kg b.w./day (90-day, dog)
Ref: July 2, 2002 - Review report for the active substance prosulfuron. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 26 February 2002 in view of the inclusion of prosulfuron in Annex I of Directive 91/414/EEC.European Commission Health & Consumer Protection Directorate-General.

http://www.fluoridealert.org/pesticides/Prosulfuron.EU.July.2002.pdf

Liver (click on for all fluorinated pesticides)

-- Short term toxicity Target / critical effect: Liver (hepatocyte hypertrophy), heart (myocardial degeneration), hematopoietic system (red blood cells decreased) Lowest relevant oral NOAEL / NOEL: NOAEL = 6 mg/kg b.w./day (90-day, dog)
-- Long term toxicity and carcinogenicity Target / critical effect: Liver (hepatocellular hypertrophy in mice), indication of hormonal disruption (uterus and mammalian gland in rats) at high dose levels Lowest relevant NOAEL: NOAEL = 1,7 mg/kg bw/day (18-month, mouse) Carcinogenicity: No carcinogenic potential
Ref: July 2, 2002 - Review report for the active substance prosulfuron. European Commission Health & Consumer Protection Directorate-General.

http://www.fluoridealert.org/pesticides/Prosulfuron.EU.July.2002.pdf

-- In an 18-month mouse carcinogenicity study, prosulfuron was administered at dose levels of 0, 1.71, 81.4, 410 or 832 mg/kg/day (males), and 0, 2.11, 100, 508 or 1,062 mg/kg/day (females). There was no evidence of carcinogenic effects up to 1,062 mg/kg/day, the HDT. The NOAEL was 1.71 mg/kg/day in males, and 100 mg/kg/day in females based on increased incidence/severity of centrilobular hepatocellular hypertrophy.
-- Chronic toxicity. Prosulfuron was fed to dogs at dosages of 0, 0.33, 1.95, 18.6 or 41.0 mg/kg/day (males) and 0, 0.31, 1.84, 20.2, or 48.8 mg/kg/day (females) for 1-year. The NOAEL was 1.84 mg/kg/day based on hematologic and clinical chemistry effects and incidence of lipofuscin accumulation in the liver at 18.6 mg/kg/day.
Ref: Federal Register: August 25, 1999. [PF-882; FRL-6093-7]. Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food.

http://www.fluorideaction.org/pesticides/prosulfuron.fr.aug.25.1999.htm

Environmental (click on for all fluorinated pesticides)

Particular conditions to be taken into account on short term basis by Member States in relation to the granting of authorisations of plant protection products containing prosulfuron On the basis of the proposed and supported uses [herbicide on maize, sorghum and sweet corn], the following particular issues have been identified as requiring particular and short term (within 12 months at the latest) attention from the Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate:

- Aquatic organisms: Member states must carefully consider the risk to aquatic plants if the active substance is applied adjacent to surface waters. The exposure input from drain flow with respect to local conditions should also be considered. Risk mitigation measures (e.g. buffer zones) should be applied where appropriate.

- Leaching to groundwater: Particular attention should be given to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.

Ref: July 2, 2002 - Review report for the active substance prosulfuron. European Commission Health & Consumer Protection Directorate-General.
http://www.fluoridealert.org/pesticides/Prosulfuron.EU.July.2002.pdf


Ref: Toxline at Toxnet as of October 14, 2003.
Note: If anyone has copies of the following studies would they please share them with FAN's Pesticide Project. Thanks- EC.

SUPPORT: LETTER FROM CIBA GEIGY CORP TO USEPA REGARDING TOXICOLOGICAL STUDIES OF CGA-152005 WITH ATTACHMENTS DATED 02-02-95

Source: EPA/OTS; Doc #89-950000124

Keywords:
CIBA GEIGY CORP
CGA-152005
HEALTH EFFECTS
SUBCHRONIC TOXICITY
MAMMALS
DOGS
ORAL
DIET
REPRODUCTION/FERTILITY EFFECTS
TERATOGENICITY
RABBITS
GAVAGE
MICE
NEUROTOXICITY
RATS

CAS No: 94125-34-5
Order Number: NTIS/OTS0529902-3

SUPPORT: LETTER FROM CIBA GEIGY CORP TO USEPA RE: TWO-YEAR DIETARY CHRONIC TOXICITY/ONCOGENICITY STUDY WITH CGA-152005 TECHNICAL IN RATS WITH ATTACHMENTS DATED 04-08-94

Source: EPA/OTS; Doc #8EHQ-0494-1104

Keywords:
CIBA GEIGY CORP
CGA-152005
HEALTH EFFECTS
CHRONIC TOXICITY
CARCINOGENICITY
MAMMALS
RATS
ORAL
DIET

CAS No: 94125-34-5
Order Number: NTIS/OTS0529902-3

SUPPORT: LETTER FROM CIBA-GEIGY CORP TO USEPA RE: 1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPROPYL)PHENYLSULFONYL]UREA, DATED 09/21/1992 (DECLASSIFIED)

Source: EPA/OTS; Doc #89920000360D

Keywords:
CIBA-GEIGY CORP
1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPRO*
HEALTH EFFECTS
CHRONIC TOXICITY
COMBINED CHRONIC TOXICITY/CARCINOGENICITY
MAMMALS
RATS
ORAL
DIET

CAS No: 94125-34-5
Order Number: NTIS/OTS0529902-4

SUPPORT: LETTER FROM CIBA-GEIGY CORP TO USEPA RE: 1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPROPYL)PHENYLSULFONYL]UREA, DATED 05/30/1991 (DECLASSIFIED)

Source: EPA/OTS; Doc #89910000154D

Keywords:
CIBA-GEIGY CORP
1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPRO*
HEALTH EFFECTS
SUBCHRONIC TOXICITY
MAMMALS
MICE
ORAL
DIET

CAS No: 94125-34-5
Order Number: NTIS/OTS0529902-4

SUPPORT: LETTER FROM CIBA-GEIGY CORP TO USEPA RE: 1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPROPYL)PHENYLSULFONYL]UREA, DATED 01/02/1991 (DECLASSIFIED)

Source: EPA/OTS; Doc #89910000026D

Keywords:
CIBA-GEIGY CORP
1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPRO*
HEALTH EFFECTS
REPRODUCTION/FERTILITY EFFECTS
TERATOGENICITY
MAMMALS
RABBITS
ORAL CAS

CAS No: 94125-34-5
Order Number: NTIS/OTS0529902-4

SUPPORT: LETTER FROM CIBA-GEIGY CORP TO USEPA RE: 1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPROPYL)PHENYLSUFONYL]UREA, DATED 09/03/1991 (DECLASSIFIED)

Source: EPA/OTS; Doc #89910000273D

Keywords:
CIBA-GEIGY CORP
1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPRO*
HEALTH EFFECTS
SUBCHRONIC TOXICITY
MAMMALS
DOGS
ORAL
DIET

CAS No: 94125-34-5
Order Number: NTIS/OTS0529902-4

INITIAL SUBMISSION: LETTER FROM CIBA-GEIGY CORP TO USEPA RE: 1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPROPYL)PHENYLSULFONYL]UREA, DATED 10/19/1990 (DECLASSIFIED)

Source: EPA/OTS; Doc #88910000017D

Keywords:
CIBA-GEIGY CORP
1-(4-METHOXY-6-METHYLTRIAZIN-2-YL)-3-[2-(3,3,3-TRIFLUOROPRO*
HEALTH EFFECTS
REPRODUCTION/FERTILITY EFFECTS
TERATOGENICITY
MAMMALS
RABBITS
ORAL
SUBCHRONIC TOXICITY
DOGS
DIET

CAS No: 94125-34-5
Order Number: NTIS/OTS0529902-4

Ref: Toxline at Toxnet as of October 14, 2003.

 
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