Adverse Effects
Primisulfuron-methyl
CAS No. 86209-51-0
 
 

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Activity: Fungicide, Herbicide (sulfonylurea)
Structure:


Adverse Effects:
Anemia
Blood
Body Weight Decrease
Bone

Endocrine: Testicular
Endocrine: Thyroid
Kidney
Liver
Spleen
Environmental

As of February 15, 2005, this herbicide is permitted in or on 24 food commodities in the United States - see list at bottom of page.


Anemia (click on for all fluorinated pesticides)

In a 90-day dog feeding study, reduced thyroid weights accompanied by colloid depletion and parafollicular hyperplasia and anemia were observed at the LOEL of 25 mg/kg/day. The NOEL was 0.625 mg/kg/day. In a 1-year dog study, dietary administration of 250/125 mg/kg/day (LOEL: the dose was changed after week 10 in the study) produced thyroid hyperplasia, anemia, increased platelet levels, vacuolar changes, and increased absolute and relative liver weights. The NOEL was 25 mg/kg/day. In an 18-month study in mice, dietary administration of 1.7 mg/kg/day produced increased absolute and relative liver weights in females. No NOEL was established...
Ref: USEPA/OPP. Support Document for the Addition of Chemicals from Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) Active Ingredients to EPCRA Section 313. U. S. Environmental Protection Agency, Washington, DC (1993). As cited by US EPA in: Federal Register: January 12, 1994. Part IV. 40 CFR Part 372. Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Proposed Rule.

Blood (click on for all fluorinated pesticides)

In a 90-day dog feeding study, reduced thyroid weights accompanied by colloid depletion and parafollicular hyperplasia and anemia were observed at the LOEL of 25 mg/kg/day. The NOEL was 0.625 mg/kg/day. In a 1-year dog study, dietary administration of 250/125 mg/kg/day (LOEL: the dose was changed after week 10 in the study) produced thyroid hyperplasia, anemia, increased platelet levels, vacuolar changes, and increased absolute and relative liver weights. The NOEL was 25 mg/kg/day. In an 18-month study in mice, dietary administration of 1.7 mg/kg/day produced increased absolute and relative liver weights in females. No NOEL was established...
Ref: USEPA/OPP. Support Document for the Addition of Chemicals from Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) Active Ingredients to EPCRA Section 313. U. S. Environmental Protection Agency, Washington, DC (1993). As cited by US EPA in: Federal Register: January 12, 1994. Part IV. 40 CFR Part 372. Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Proposed Rule.

Body Weight Decrease (click on for all fluorinated pesticides)

-- Chronic toxicity: Doses of 125 mg/kg/day administered in the diet to dogs over a 1-year period produced decreased body weight gain, anemia, increased liver weight, and thyroid hyperplasia (abnormal growth) [15]. Rats fed dietary doses of about 180 mg/kg/day over 90 days showed effects similar to those noted in dogs, as well as spleen weight increases [24]. In another study, doses of 480 mg/kg/day in rats over 18 months produced increased incidence of tooth disorders, chronic nephritis (kidney damage), and testicular atrophy [4]. In two 18-month studies in mice, testicular atrophy, chronic nephritis, and increased tooth and bone disorders were seen at doses of 180 mg/kg/day and 360 mg/kg/day, respectively [4].
-- Reproductive effects: Changes in the function of the testes were noted in rats fed high doses (250 mg/kg/day) of primisulfuron-methyl over two generations. There was also a decrease in the body weight of the offspring. No compound-related effects on reproduction were noted at doses below 50 mg/kg/day [15]. Testicular atrophy was seen in rats in chronic studies (see above), which could result in reproductive effects. The available data suggest that reproductive effects in humans due to primisulfuron are not likely under normal circumstances.
Ref: E X T O X N E T Extension Toxicology Network Pesticide Information Profiles.
Revised June 1996.
http://ace.ace.orst.edu/info/extoxnet/pips/primisul.htm

Bone (click on for all fluorinated pesticides)

-- Chronic toxicity: Doses of 125 mg/kg/day administered in the diet to dogs over a 1-year period produced decreased body weight gain, anemia, increased liver weight, and thyroid hyperplasia (abnormal growth) [15]. Rats fed dietary doses of about 180 mg/kg/day over 90 days showed effects similar to those noted in dogs, as well as spleen weight increases [24]. In another study, doses of 480 mg/kg/day in rats over 18 months produced increased incidence of tooth disorders, chronic nephritis (kidney damage), and testicular atrophy [4]. In two 18-month studies in mice, testicular atrophy, chronic nephritis, and increased tooth and bone disorders were seen at doses of 180 mg/kg/day and 360 mg/kg/day, respectively [4].
-- Teratogenic effects: No teratological effects were seen in offspring of rabbits given doses of up to 600 mg/kg/day. In one study of rats, delayed skeletal development and lack of ossification was seen in offspring of pregnant rats given doses of 500 mg/kg/day, while in another, 100 mg/kg/day produced incomplete ossification of the pubic bone [15]. The available evidence suggests that primisulfuron-methyl is not teratogenic except at very high doses.
-- Organ toxicity: Target organs identified in animal studies include the liver, kidneys, spleen, and testes, as well as the skeleton.
Ref: E X T O X N E T Extension Toxicology Network Pesticide Information Profiles. Revised June 1996.

http://ace.ace.orst.edu/info/extoxnet/pips/primisul.htm

-- Acute toxicity. For acute dietary risk assessment, the Agency used a NOEL of 100 mg/kg/day, based on delayed or absent ossification effects in fetuses at the LEL of 500 mg/kg/day, from the oral developmental study in rats. This risk assessment will evaluate acute dietary risk to the population subgroup of concern, females 13+ years of age... Acute risk. The finding of developmental effects in the rat study absent ossification required that an acute dietary risk assessment be performed for females 13+ years of age. The calculated MOE of 71,000 demonstrated that acute pre-natal developmental risks were below EPA's level of concern.
Ref: Federal Register: December 17, 1997.Primisulfuron-methyl; Pesticide Tolerances for Emergency Exemptions. Final Rule.

http://www.fluoridealert.org/pesticides/Primisulfuron-methyl.FR.97.htm

Endocrine: Testicular (click on for all fluorinated pesticides)

-- Chronic toxicity: Doses of 125 mg/kg/day administered in the diet to dogs over a 1-year period produced decreased body weight gain, anemia, increased liver weight, and thyroid hyperplasia (abnormal growth) [15]. Rats fed dietary doses of about 180 mg/kg/day over 90 days showed effects similar to those noted in dogs, as well as spleen weight increases [24]. In another study, doses of 480 mg/kg/day in rats over 18 months produced increased incidence of tooth disorders, chronic nephritis (kidney damage), and testicular atrophy [4]. In two 18-month studies in mice, testicular atrophy, chronic nephritis, and increased tooth and bone disorders were seen at doses of 180 mg/kg/day and 360 mg/kg/day, respectively [4].
-- Reproductive effects: Changes in the function of the testes were noted in rats fed high doses (250 mg/kg/day) of primisulfuron-methyl over two generations. There was also a decrease in the body weight of the offspring. No compound-related effects on reproduction were noted at doses below 50 mg/kg/day [15]. Testicular atrophy was seen in rats in chronic studies (see above), which could result in reproductive effects. The available data suggest that reproductive effects in humans due to primisulfuron are not likely under normal circumstances.
-- Organ toxicity: Target organs identified in animal studies include the liver, kidneys, spleen, and
testes, as well as the skeleton.
Ref: E X T O X N E T Extension Toxicology Network Pesticide Information Profiles. Revised June 1996.

http://ace.ace.orst.edu/info/extoxnet/pips/primisul.htm

Endocrine: Thyroid (click on for all fluorinated pesticides)

-- Chronic toxicity: Doses of 125 mg/kg/day administered in the diet to dogs over a 1-year period produced decreased body weight gain, anemia, increased liver weight, and thyroid hyperplasia (abnormal growth) [15]. Rats fed dietary doses of about 180 mg/kg/day over 90 days showed effects similar to those noted in dogs, as well as spleen weight increases [24]. In another study, doses of 480 mg/kg/day in rats over 18 months produced increased incidence of tooth disorders, chronic nephritis (kidney damage), and testicular atrophy [4]. In two 18-month studies in mice, testicular atrophy, chronic nephritis, and increased tooth and bone disorders were seen at doses of 180 mg/kg/day and 360 mg/kg/day, respectively [4].
Ref: E X T O X N E T Extension Toxicology Network Pesticide Information Profiles. Revised June 1996.

http://ace.ace.orst.edu/info/extoxnet/pips/primisul.htm

In a 90-day dog feeding study, reduced thyroid weights accompanied by colloid depletion and parafollicular hyperplasia and anemia were observed at the LOEL of 25 mg/kg/day. The NOEL was 0.625 mg/kg/day. In a 1-year dog study, dietary administration of 250/125 mg/kg/day (LOEL: the dose was changed after week 10 in the study) produced thyroid hyperplasia, anemia, increased platelet levels, vacuolar changes, and increased absolute and relative liver weights. The NOEL was 25 mg/kg/day. In an 18-month study in mice, dietary administration of 1.7 mg/kg/day produced increased absolute and relative liver weights in females. No NOEL was established. Based on this study, an oral RfD of 0.006 mg/kg/day was derived. In a 2-year mouse study, increases in absolute and relative liver weights were observed at 408 mg/kg/day in males and 1.7 mg/kg/day in females. The systemic LOEL and NOEL in males was 408 mg/kg/day and 40.2 mg/kg/day, respectively. The systemic LOEL in females was 1.7 mg/kg/day and a NOEL could not be established. EPA believes that there is sufficient evidence for listing primisulfuron on EPCRA section 313 pursuant to EPCRA section 313(d)(2)(B) based on the available thyroid and liver toxicity data for this chemical.
Ref: USEPA/OPP. Support Document for the Addition of Chemicals from Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) Active Ingredients to EPCRA Section 313. U. S. Environmental Protection Agency, Washington, DC (1993). As cited by US EPA in: Federal Register: January 12, 1994. Part IV. 40 CFR Part 372. Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Proposed Rule.

Kidney (click on for all fluorinated pesticides)

-- Chronic toxicity: Doses of 125 mg/kg/day administered in the diet to dogs over a 1-year period produced decreased body weight gain, anemia, increased liver weight, and thyroid hyperplasia (abnormal growth) [15]. Rats fed dietary doses of about 180 mg/kg/day over 90 days showed effects similar to those noted in dogs, as well as spleen weight increases [24]. In another study, doses of 480 mg/kg/day in rats over 18 months produced increased incidence of tooth disorders, chronic nephritis (kidney damage), and testicular atrophy [4]. In two 18-month studies in mice, testicular atrophy, chronic nephritis, and increased tooth and bone disorders were seen at doses of 180 mg/kg/day and 360 mg/kg/day, respectively [4].
-- Organ toxicity: Target organs identified in animal studies include the liver,
kidneys, spleen, and testes, as well as the skeleton.
Ref: E X T O X N E T Extension Toxicology Network Pesticide Information Profiles. Revised June 1996.

http://ace.ace.orst.edu/info/extoxnet/pips/primisul.htm

Liver (click on for all fluorinated pesticides)

-- Chronic toxicity: Doses of 125 mg/kg/day administered in the diet to dogs over a 1-year period produced decreased body weight gain, anemia, increased liver weight, and thyroid hyperplasia (abnormal growth) [15]...
-- Reproductive effects: Changes in the function of the testes were noted in rats fed high doses (250 mg/kg/day) of primisulfuron-methyl over two generations. There was also a decrease in the body weight of the offspring. No compound-related effects on reproduction were noted at doses below 50 mg/kg/day [15]. Testicular atrophy was seen in rats in chronic studies (see above),
which could result in reproductive effects. The available data suggest that reproductive effects in humans due to primisulfuron are not likely under normal circumstances.
-- Organ toxicity: Target organs identified in animal studies include the liver, kidneys, spleen, and testes
, as well as the skeleton.
Ref: E X T O X N E T Extension Toxicology Network Pesticide Information Profiles. Revised June 1996.

http://ace.ace.orst.edu/info/extoxnet/pips/primisul.htm

-- Chronic toxicity. EPA has established the RfD for primisulfuron- methyl at 0.006 milligrams/kilogram/day (mg/kg/day). This RfD is based on an 80-week mouse feeding study with a LOEL of 1.7 mg/kg/day based on increased absolute and relative liver weights. An uncertainty factor of 300 was used because a NOEL was not achieved.Carcinogenicity. Primisulfuron-methyl has been classified as a Group D chemical incomplete evidence based on liver tumors in mice.
Ref: Federal Register: December 17, 1997.Primisulfuron-methyl; Pesticide Tolerances for Emergency Exemptions. Final Rule.
http://www.fluoridealert.org/pesticides/Primisulfuron-methyl.FR.97.htm


In a 1-year dog study, dietary administration of 250/125 mg/kg/day (LOEL: the dose was changed after week 10 in the study) produced thyroid hyperplasia, anemia, increased platelet levels, vacuolar changes, and increased absolute and relative liver weights. The NOEL was 25 mg/kg/day. In an 18-month study in mice, dietary administration of 1.7 mg/kg/day produced increased absolute and relative liver weights in females. No NOEL was established. Based on this study, an oral RfD of 0.006 mg/kg/day was derived. In a 2-year mouse study, increases in absolute and relative liver weights were observed at 408 mg/kg/day in males and 1.7 mg/kg/day in females. The systemic LOEL and NOEL in males was 408 mg/kg/day and 40.2 mg/kg/day, respectively. The systemic LOEL in females was 1.7 mg/kg/day and a NOEL could not be established. EPA believes that there is sufficient evidence for listing primisulfuron on EPCRA section 313 pursuant to EPCRA section 313(d)(2)(B) based on the available thyroid and liver toxicity data for this chemical.
Ref: USEPA/OPP. Support Document for the Addition of Chemicals from Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) Active Ingredients to EPCRA Section 313. U. S. Environmental Protection Agency, Washington, DC (1993). As cited by US EPA in: Federal Register: January 12, 1994. Part IV. 40 CFR Part 372. Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Proposed Rule.

Spleen (click on for all fluorinated pesticides)

Organ toxicity: Target organs identified in animal studies include the liver, kidneys, spleen, and testes, as well as the skeleton.
Ref: E X T O X N E T Extension Toxicology Network Pesticide Information Profiles. Revised June 1996.

http://ace.ace.orst.edu/info/extoxnet/pips/primisul.htm

Environmental (click on for all fluorinated pesticides)

Plant toxicity values include a duckweed 14-day EC 50 of 0.27 ppb and an algae 7-day EC 50 of 24 ppb. EPA believes that there is sufficient evidence for listing primisulfuron on EPCRA section 313 pursuant to EPCRA section 313(d)(2)(C) based on the available environmental toxicity data for this chemical.
Ref: USEPA/OPP. Support Document for the Addition of Chemicals from Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) Active Ingredients to EPCRA Section 313. U. S. Environmental Protection Agency, Washington, DC (1993). As cited by US EPA in: Federal Register: January 12, 1994. Part IV. 40 CFR Part 372. Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Proposed Rule.


A February 15, 2005, check at the Code of Federal Regulations for Primisulfuron-methyl: this herbicide is permitted in or on 24 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: 40CFR180.452]
[Page 460]

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. 180.452 Primisulfuron-methyl; tolerances for residues.
(a) General. Tolerances are established for residues of
primisulfuron-methyl (3-[4,6-bis-(difluoromethoxy)-pyrimidin-2-yl]-1-(2-
methoxycarbonylphenylsulfonyl) urea) in or on the following raw
agricultural commodities.
Crop

As of October 8, 2003

PPM

As of
February 15,
2005

PPM

Cattle, fat 0.1 0.10
Cattle, meat 0.1 0.10
Cattle, meat byproducts 0.1 0.10
Corn, forage 0.1 0.10
Corn, fresh (including sweet kernels plus cobs with husks removed) 0.1 0.10
Corn, grain 0.02 0.02
Corn, stover Not listed 0.10
Egg 0.1 0.10
Goat, fat 0.1 0.10
Goat, meat 0.1 0.10
Goat, meat byproducts 0.1 0.10
Hog, fat 0.1 0.10
Hog, meat 0.1 0.10
Hog, meat byproducts 0.1 0.10
Horse, fat 0.1 0.10
Horse, meat 0.1 0.10
Horse, meat byproducts 0.1 0.10
Milk 0.02 0.02
Poultry, fat 0.1 0.10
Poultry, meat 0.1 0.10
Poultry, meat byproducts 0.1 0.10
Sheep, fat 0.1 0.10
Sheep, meat 0.1 0.10
Sheep, meat byproducts 0.1 0.10
CATTLE, FAT 0.1 metabolites not listed
CATTLE, MEAT 0.1 metabolites not listed
CATTLE, MEAT BYPRODUCTS 0.1 metabolites not listed
CORN, FODDER 0.1 Not listed
CORN, FODDER 0.1 metabolites not listed
CORN, FORAGE 0.1 metabolites not listed
CORN, FRESH (INC. SWEET)(K+CWHR) 0.1 metabolites not listed
CORN, GRAIN 0.02 metabolites not listed
EGG 0.1 metabolites not listed
GOAT, FAT 0.1 metabolites not listed
GOAT, MEAT 0.1 metabolites not listed
GOAT, MEAT BYPRODUCTS 0.1 metabolites not listed
HOG, FAT 0.1 metabolites not listed
HOG, MEAT 0.1 metabolites not listed
HOG, MEAT BYPRODUCTS 0.1 metabolites not listed
HORSE, FAT 0.1 metabolites not listed
HORSE, MEAT 0.1 metabolites not listed
HORSE, MEAT BYPRODUCTS 0.1 metabolites not listed
MILK 0.02 metabolites not listed
POULTRY, FAT 0.1 metabolites not listed
POULTRY, MEAT 0.1 metabolites not listed
POULTRY, MEAT BYPRODUCTS 0.1 metabolites not listed
SHEEP, FAT 0.1 metabolites not listed
SHEEP, MEAT 0.1 metabolites not listed
SHEEP, MEAT BYPRODUCTS 0.1 metabolites not listed
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
 
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