Adverse Effects


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Activity: Herbicide (triazolopyrimidine)

Adverse Effects:

• Very little toxicological data available up to September 24, 2004, when EPA released the following documents. EPA lists Flumetsulam as a "low-risk" pesticide, however, several studies have not been done, eg:
-- A neurotoxicity study was not conducted,
-- A 90-day inhalation study and a subchronic dog study were not conducted
-- A developmental neurotoxicity study is not required since there was no evidence of neurotoxicity or neuropathy from the available studies.
-- Due to the lack of repeated dose inhalation toxicity study, oral studies were selected for the appropriate duration of exposure. Absorption via inhalation is assumed to be equivalent to oral absorption.

TRED (Tolerance Reassessment Decision) (TRED) documents:
Sept 9, 2004

Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED) for Flumetsulam

5 pages

Signed by:
Debra Edwards,
Director, Special Review and Reregistration Div.

Mika J. Hunter - contact for questions regarding this decision.

EPA OPPT (7508C)
Aug 31, 2004

Flumetsulam: HED Risk Assessment for the Tolerance Reassessment Eligibility Document (TRED).

23 pages

Memorandum From:

Elissa Reaves, Toxicologist Reregistration Branch II, Health Effects Div. (7509C)

EPA OPPT (7509C)
Aug 30, 2004

Flumetsulam. Chronic Dietary Exposure Assessment for the TRED document.

8 pages

Memorandum From:

Samuel Ary, Chemist, Reregistration Branch II, Health Effects Div. (7509C)

EPA OPPT (7509C)

DP Barcode: D306279

PC Code: 129016

Aug 31, 2004

Flumetsulam. Summary of Analytical Chemistry and Residue Data for the Tolerance Reassessment Eligibility Decision (TRED) Document.

32 pages

Memorandum From:

Samuel Ary, Chemist
Reregistration Branch II, Health Effects Div. (7509C)

This summary of analytical chemistry and residue data document was originally prepared under contract by Versar, Inc. (Springfield, VA 22151; submitted June 11, 2004).

EPA OPPT (7509C)

DP Barcode: D306242

PC Code: 129016

May 19, 2004

Drinking Water Assessment for Flumetsulam for Uses on Field Corn and Soybeans

15 pages

Memorandum From:

James Lin, Environmental Engineer,
Stephanie Syslo, RAPL
Environmental Risk Branch III Environmental Fate and Effects Div. (7507C)

EPA OPP (7507C)

PC Code: 129016

DPBarcode: 301361

• As of February 16, 2005, this herbicide is permitted in or on the food commodities corn and soybean in the United States - see list at the bottom of page.

Kidney (click on for all fluorinated pesticides)

-- 90-Day oral toxicity, Rat - NOAEL (M/F) 250 mg/kg/day. LOAEL (M/F) 1000 mg/kg/day based on severe bilateral tubular-interstitial nephritis.
-- -- The kidney appears to be the primary target organ of rats and dogs following subchronic to chronic exposures.
Ref: August 31, 2004: Flumetsulam: HED Risk Assessment for the Tolerance Reassessment Eligibility Document (TRED).

Chronic toxicity. In a 1-year dietary study in dogs, the NOEL was 100 mg/kg/day and the LOEL was 500 mg/kg/day. The animals were administered feed containing 0, 20, 100, and 500 mg/kg/day. Reduced body weights and inflammatory and atrophic changes in the kidneys occurred in the 500 mg/kg/day dose groups. In a combined feeding carcinogenicity/chronic study in mice there were no treatment-related effects and there was no evidence of a carcinogenic response. Systemic NOEL was greater than or equal to 1,000 mg/kg/day (limit dose); a LOEL was not established. In a combined feeding carcinogenicity/chronic study in rats, renal pathological alterations were seen in males. No treatment-related effects were seen in females at the highest dose (1,000 mg/kg/day) which is the limit dose. There was no carcinogenic response. The NOELs were 500 mg/kg/day in males and 1,000mg/kg/day in females. The LOEL was 1,000 mg/kg/day in males; a LOEL was not established in females. Based on the chronic toxicity data, EPA has established the RfD for flumetsulam at 1.0 milligram (mg)/kilogram (kg)/day. The RfD for flumetsulam is based on the 1-year chronic study in dogs with a NOEL of 100 mg/kg/day and an uncertainty (or safety) factor of 100. Thus, it would not be necessary to require the application of an additional uncertainty factor above the 100-fold factor already applied to the NOEL.
Ref: Federal Register: September 17, 1997 [Notices] [Page 48842-48848]. Notice of Filing of Pesticide Petitions.

Environmental (click on for all fluorinated pesticides)

Abstract: ... To obtain information on the occurrence of SU, SA, and IMI herbicides in the Midwestern United States, 212 water samples were collected from 75 surface-water and 25 ground-water sites in 1998. These samples were analyzed for 16 SU, SA and IMI herbicides by USGS Methods Research and Development Program staff using high-performance liquid chromatography/mass spectrometry. Samples were also analyzed for 47 pesticides or pesticide degradation products. At least one of the 16 SUs, SAs or IMIs was detected above the method reporting limit (MRL) of 0.01 microg/l in 83% of 130 stream samples. Imazethapyr was detected most frequently (71% of samples) followed by flumetsulam (63% of samples) and nicosulfuron (52% of samples)...
Ref: Battaglin WA et al (2000). Occurrence of sulfonylurea, sulfonamide, imidazolinone, and other herbicides in rivers, reservoirs and ground water in the Midwestern United States, 1998. Sci Total Environ. Apr 5;248(2-3):123-33.

Flumetsulam. Data from Pesticide Action Network
Common Name Scientific Name Avg Species LC50 (ug/L) Number of Studies Avg Species Rating
Bluegill Lepomis macrochirus 300.0 1 Highly Toxic
Atlantic silverside Menidia menidia 380.0 1 Highly Toxic
Rainbow trout,donaldson trout Oncorhynchus mykiss 300.0 1 Highly Toxic
Fathead minnow Pimephales promelas 293.0 1 Highly Toxic
Marsh grass shrimp Palaemonetes vulgaris 349.0 1 Highly Toxic

A  February 16, 2005, check at the Code of Federal Regulations for Flumetsulam: this herbicide is permitted in or on 4 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: 40CFR180.468]
[Page 465]



IN FOOD--Table of Contents

Subpart C_Specific Tolerances

Sec. 180.468 Flumetsulam; tolerances for residues.
Tolerances are established for residues of the herbicide
flumetsulam, N-(2,6-difluorophenyl)-5-methyl-(1,2,4)-triazolo-[1,5a]-
pyrimidine-2-sulfonamide, in or on the following raw agricultural
Commodity Parts per million
Corn, field, grain 0.05
Corn, field, forage 0.05
Corn, field, stover 0.05
Soybean 0.05

[58 FR 57967, Oct. 28, 1993]

[[Page 466]]

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