Fluazinam
CAS No. 79622-59-6
 
 

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Adverse Effects
Abstracts

ACTIVITY: Fungicide (2,6-Dinitroaniline)

CAS Name: 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-2-pyridinamine

Structure:

Adverse Effects:

Body Weight Decrease
Bone (including Cleft Palate)
Brain
Cancer- Suggestive evidence: THYROID, LIVER
Cholesterol
Dermal
Endocrine: Testicular
Endocrine: Thymus
Endocrine: Thyroid
Endocrine: Uterus
Eye
Liver
Lung
Pancreas
Spinal Cord
Stomach

Environmental Effects:

Fluazinam is of very high toxic risk to freshwater aquatic organisms, of high toxic risk to marine aquatic organisms, and of high dietary and reproductive risk to wild mammals.

Moderately persistent in soil with significant carryover of residues to the next season

Suggestive chronic effects (reduced growth in young) in birds

Regulatory Information
(only comprehensive for the US)
US EPA Registered: Yes 
US EPA PC Code: 129098 
California Chemical Code 3898 
US Tolerances: CFR 180.574  
FDA LMS Code: B54
Registered use in
(includes only a limited list of countries)

Australia, Canada, Denmark, Finland, Germany, Hungary, Japan, Netherlands, New Zealand, Philippines, Portugal, UK, US

Canada: potato

Japan: Maximum Residue Levels (MRLS) Apple • Asparagus • Beans (dry) • Broccoli • Brussels sprouts • Burdock • Cabbage • Cauliflower • Cherry • Grape • Grapefruit • Japanese pear • Japanese persimon • Kiwifruit • Lemon • Lettuce (Cos lettuce, Leaf lettuce) • Lime • Loquat • Mume plum • NATSUDAIDAI (whole) • Onion • Orange (including Navel) • Other Citrus fruits • Other Cruciferous vegetables • Other Liliaceous vegetables • Peach • Pear • Pineapple • Potato • Sugar beet • Tea • Turnip • Welsh (including Leek) • UNSHU orange • Yam  
US Maximum Residue Levels permitted in food commodities

Peanut, Potato, Grape (wine) 

On April 18, 2002, US EPA established an import tolerance for residues of fluazinam and its metabolite AMGT3 in or on wine grapes at 3.0 ppm.

Other Information
Molecular Formula: C13H4Cl2 F6 N4O4
Entry Year: 1990  
Manufacturers: Syngenta, ISK 
Other Names: B-1216,
IKF-1216
Manufacture site: FRANCE:
SNPE, Paris
 
Of special interest:
PAN Data 
• new - Fluazinam: Material Safety Data Sheets and Labels
July 19, 2005 - Canada. Reduced-Risk Update. Report: RR2005-02. Canada Pest Management Regulatory Agency (PMRA).
See excerpted list of fluorinated pesticides.
October 27, 2003. - Canada: Regulatory Note REG2003-12. Fluazinam. Pest Management Regulatory Agency. Health Canada. Ottawa.
http://www.fluorideaction.org/pesticides/fluazinam.canada.report2003.pdf
August 10, 2001 - Pesticide Fact Sheet. US EPA 
Abstracts 
Material Safety Data Sheet for Shirlan® Fungicide 
October 2001- Glossary of Pesticide Chemicals. A listing of pesticides subject to analysis of residues in foods and feeds by the US Food and Drug Administration. 
August 2001 - IR-4: New Products/Transitional Solution List - This list contains brief descriptions of numerous new pest control materials that have been introduced over the last several years. Additionally, it contains information on some "older" crop protection chemicals that are believed to have room for new uses. This List includes Fluazinam  
2002 - NIPON SODA ANNUAL REPORT 2002 - cites the following organofluorine pesticides and their product names: Chlorfenapyr * Fluacrypyrim * Fluazinam * Fluvalinate * Triflumizole 

In subchronic and chronic toxicity studies, fluazinam targeted the following organs: liver, lung, uterus, testes, pancreas, thymus, thyroid, stomach, eyes and brain. Generalized toxicity was observed in rats, mice and dogs as decreases in body weight, body-weight gain, food consumption and/or food efficiency. Liver toxicity was evident in most studies including increased size and weight, fatty changes, pallor, as well as hepatocyte hypertrophy, necrosis and apoptosis. Thyroid toxicity was less common, but included follicular hyperplasia and cystic thyroid follicles. Endocrine-related effects included small and/or flaccid testes, testicular tubular atrophy, pancreatic exocrine atrophy and thymic hyperplasia.
Ref: Canada: Regulatory Note REG2003-12. Fluazinam. Pest Management Regulatory Agency. Health Canada. Ottawa. October 27, 2003.
http://www.fluorideaction.org/pesticides/fluazinam.canada.report2003.pdf


US Federal Register

•• Note: Due to length, the following is a partial list. Click here to see full list of FR entries.

Date Published Docket Identification Number Details
October 24, 2007 EPA-HQ-OPP-2007-0234

IR-4 and ISK Biosciences. Pesticide tolerance. FINAL RULE for PP 6E7137. Documents available in the docket are:

Fluazinam: Human Health Risk Assessment for Proposed Use on Edible-Podded beams. Shelled and Succulent and Dried Beans, Bassica Lafy Vegetables, Bushberriews, and Gingseng. August 22,2007. EPA Office of Pesticides. Docket No. EPA-HQ-OPP-2007-0234-0004.

Fluazinam Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Secion 3 Registration Action on Gingseng, Brassica Vegetables, Legume Vegetables, and Bushberries. August 1, 2007. US EPA Office of Pesticides. Docket No. EPA-HQ-OPP-2007-0234-0005.

Tier I Estimated Drinking Waters Concentrations of Fluazinam and Total Residues for the Use in the Human Health Risk Assessment; IR4 Petition for the Use of Fluazinam on Edible-Podded Legume Vegetables (except peas), Bushberry (crop subgroup 13B), Brassica (Cole) Leafy Vegetables, Ginseng, and Dry, and Succulent Bean Crop Subgroup 6B (except peas) 10/24/2007. February 7, 2007. Docket No. EPA-HQ-OPP-2007-0234-0007.

Fluazinam. Tolerance Petitions Requesting the Establishment of Permanent Tolerances (Associated with Section 3 Registration) for Food Use of the Herbicide on Edible-Podded Beans (Subgroup 6-A, Except Peas), Shelled Succulent Beans (Subgroup 6-B, Except Peas), Shelled Dried Beans (Subgroup 6-C, Except Peas), Brassica (Cole) Vegetables (Group 5), Bushberries (Subgroup 13-B), and Ginseng. Summary of Analytical Chemistry and Residue Data. August 22, 2007. US EPA Office of Pesticides. Docket No. EPA-HQ-OPP-2007-0234-0006.

Fluazinam: Company Notice of Filing. January 1, 2006. Docket No. EPA-HQ-OPP-2007-0234-0002.

Commodity

PPM

FINAL RULE:

PPM:

PETITIONED:

EPA's rationale for increasing tolerance:

Aronia berry
7.0
4.5
Note 1
Buffalo currant
7.0
4.5
Note 1

Bushberry subgroup 13B. This subgroup includes 5 commodities:

blueberry • currant • elderberry • gooseberry • huckleberry

7.0
4.5
Note 1
Chilean guava
7.0
4.5
Note 1
European barberry
7.0
4.5
Note 1
Ginseng
4.5
3.0
Note 5
Highbush cranberry
7.0
4.5
Note 1
Honeysuckle, edible
7.0
4.5
Note 1
Jostaberry
7.0
4.5
Note 1
Juneberry
7.0
4.5
Note 1
Lingonberry
7.0
4.5
Note 1
Native currant
7.0
4.5
Note 1
Pea and bean, dried shelled, except soybean, subgroup 6C, except pea. This subgroup includes 27 commodities.

bean, adzuki • bean, broad dry • bean, dry • bean, kidney • bean, lablab • bean, lima dry • bean, moth • bean, mung • bean, navy • bean, pink • bean, pinto • bean, rice • bean, tepary • bean, urd • catjang • chickpea • cowpea • guar • lentil • lupin, grain • lupin, sweet • pea, blackeyed • pea, crowder • pea, field • pea, field seed • pea, pigeon • pea, southern

0.02
0.01
Note 2

Pea and bean, succulent shelled, subgroup 6B, except pea. This subgroup includes 10 commodities:

bean, broad succulent • bean, lima succulent • cowpea • cowpea seed • pea, blackeyed • pea, english • pea, garden • pea, green • pea, pigeon • pea, southern

0.04
0.02
Note 2
Salal
7.0
4.5
Note 1
Sea buckthorn
7.0
4.5
Note 1
Turnip, greens
0.01
0.02
Note 4
Vegetable, Brassica leafy, group 5. This group includes 16 commodities.

broccoli • broccoli raab • broccoli, chinese • brussels sprouts • cabbage • cabbage, chinese, bok choy • cabbage, chinese, mustard • cabbage, chinese, napa • cauliflower • collards • kale • kohlrabi • mustard greens • mustard spinach • rape greens • vegetable, brassica, leafy, group

0.01
0.02
Note 4

Vegetable, legume, edible-podded, subgroup 6A, except pea. This subgroup includes14 commodities.

bean, moth • bean, runner • bean, snap • bean, wax • bean, yardlong • jackbean • longbean, chinese • pea, dwarf • pea, edible podded • pea, pigeon • pea, snow • pea, sugar snap • soybean immature seed • swordbean

0.10
0.15
Note 3

Note 1: The tolerances for Bushberry subgroup 13B and related berries were increased from 4.5 ppm to 7.0 ppm based on analyses of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data. Although IR-4 proposed tolerances for combined residues of fluazinam and AMGT on these commodities, EPA determined, based on the low levels of AMGT seen in the field trials, that only parent fluazinam should be included in the tolerance expression.

Note 2: The commodity terms for dry beans and succulent shelled legumes were revised to read ``Pea and bean, dried shelled, except soybean, subgroup 6C, except pea'' and ``Pea and bean, succulent shelled, subgroup 6B, except pea'' to agree with recommended commodity terms in the Office of Pesticide Program's Food and Feed Commodity Vocabulary. Tolerances for these commodities were increased from 0.01 ppm to 0.02 ppm (dried) and from 0.02 ppm to 0.04 ppm (succulent) to account for the 50% dissipation of residues observed in the storage stability study.

Note 3: The commodity term for edible-podded legume vegetables was revised to read ``Vegetable, legume, edible-podded, subgroup 6A, except pea'' to agree with the Food and Feed Commodity Vocabulary. The tolerance level was decreased from 0.15 ppm to 0.10 ppm based on maximum residues seen in the field trials, since 80% of the residues were non-detectable and, therefore, not appropriate for analysis using the Tolerance Spreadsheet.

Note 4: IR-4 proposed separate tolerances of 0.02 ppm and 0.01 ppm for ``Leafy Brassica greens subgroup'' and ``Head and stem Brassica subgroup'', respectively. EPA determined that a single tolerance of 0.01 ppm covering the entire crop group ``Vegetable, Brassica leafy, group 5'' would be appropriate, based on the results of field trials showing no residues above the method limit of quantitation (LOQ) in any of the representative commodities (broccoli, cabbage and mustard greens). The tolerance for turnip greens was revised from 0.02 to 0.01 ppm on the same basis.

Note 5: The tolerance for ginseng was increased from 3.00 ppm to 4.5 ppm to account for dissipation of residues observed in the storage stability study.

Cancer. In accordance with the 2005 Guidelines for Carcinogen Risk Assessment, for fluazinam there is ``Suggestive evidence of carcinogenic potential.'' This determination is based on weight of evidence considerations where a concern for potential carcinogenic effects in humans is raised, but the animal data are judged not sufficient for a stronger conclusion. Carcinogenicity studies were conducted in rats and mice . In mice, there were conflicting results with regard to hepatocarcinogenicity. In the second study, carcinogenic response was equivocal and tumors did not occur in a dose-related manner. In males, the dose that induced liver tumors in the first study failed to induce liver tumors in the same strain of mice in the second study. In the second study, in females, liver tumors were seen only at an excessive toxic dose. There was no evidence of mutagenicity either in in vivo or in vitro assays. No chemicals structurally related to fluazinam were identified as carcinogens. Since the evidence for carcinogenicity is not sufficient to indicate anything greater than a suggestion of a carcinogenic potential, EPA concludes that quantification of cancer risk would not be scientifically appropriate, as it attaches greater significance to the positive cancer findings than the entire dataset warrants. Further, due to the equivocal and inconsistent nature of the cancer response in the rat and mouse studies (in rats, effects seen only in males; in mice, one study showed effects only in males but even these effects were not reproducible), EPA finds that when judged qualitatively the data indicate no greater than a negligible risk of cancer. Additionally, it is noted that the point of departure (1.1 mg/kg/day) selected for deriving the chronic reference dose will adequately account for all chronic effects determined to result from exposure to fluazinam in chronic animal studies, including the equivocal cancer effects.

there was evidence of increased qualitative susceptibility of fetuses to fluazinam in the developmental toxicity study in rats. In this study, increased incidences of facial/palate clefts and other rare deformities in the fetuses were observed in the presence of minimal maternal toxicity. In a developmental neurotoxicity study, decreases in body weight and body weight gain and a delay in completion of balano-preputial separation were observed in pups. These effects were seen in the absence of maternal effects, suggesting increased quantitative susceptibility of the offspring.

Quantitative evidence of increased susceptibility was also observed in a developmental neurotoxicity study in rats. In pups, there were decreases in body weight and body weight gain during lactation, and delayed preputial separation observed at 10 mg/kg/day (NOAEL=2 mg/kg/ day). Although the NOAEL of 2 mg/kg/day is lower than that used for the acute RfD for females 13-49 (7 mg/kg/day), the effects noted in the developmental neurotoxicity study are attributable to multiple doses and are considered postnatal effects. Therefore, the study endpoint is not appropriate either for acute dietary exposures or for use with the population subgroup females 13-49 (with this subgroup the concern is for prenatal exposures). The chronic RfD of 0.011 mg/kg/day is based on a lower NOAEL of 1.1 mg/kg/day and is considered protective of potential developmental effects.

EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X.

April 30, 2007 EPA-HQ-OPP-2007-0234

IR-4. Petition for New Tolerances. PPs 6E7137 and PP 6E7139. Proposal to establish a tolerance for residues of the fungicide fluazinam in or on food commodities in: ; ; and . IR-4 also proposes to establish a tolerance for residues of fluazinam and its metabolite AMGT in or on the following food commodities:An analytical method using gas chromatography with electron capture detection (GC-ECD) for the determination of fluazinam residues on beans (snap, lima, and dry), Brassica crops (broccoli, cabbage and mustard greens), ginseng and blueberry has been developed and validated.

Petition PP 6E7137 for residues of fluazinam PPM

Vegetable, legume, edible podded, subgroup 6A, except pea

This subgroup includes 14 commodities.
bean, moth • bean, runner • bean, snap • bean, wax • bean, yardlong • jackbean • longbean, chinese • pea, dwarf • pea, edible podded • pea, pigeon • pea, snow • pea, sugar snap • soybean immature seed • swordbean

0.15

Brassica, head and stem, subgroup 5A

This subgroup includes 10 commodities.
broccoli • broccoli, cavalo • broccoli, chinese • brussels sprout • cabbage • cabbage, chinese mustard • cabbage, chinese napa • cauliflower • cavalo broccolo • kohlrabi

0.01

Brassica, leafy greens, subgroup 5B

This subgroup includes 8 commodities.
broccoli raab • cabbage, chinese bok choy • collards • kale • mizuna • mustard greens • mustard spinach • rape greens

0.02
turnip, tops 0.02
Petition PP 6E7137 for residues of fluazinam and its metabolite AMGT

Bushberry subgroup 13B

This subgroup includes 5 commodities.
blueberry • currant • elderberry • gooseberry • huckleberry

4.5
berry, aronia 4.5
blueberry, lowbush 4.5
currant, buffalo 4.5
guava, chilean 4.5
barberry, European 4.5
cranberry, highbush 4.5
honeysuckle 4.5
jostaberry 4.5
Juneberry 4.5
lingonberry 4.5
currant, native 4.5
salal 4.5
buckthorn, sea 4.5
Petition PP 6E7139 for residues of fluazinam
Ginseng 3.0
bean, dry 0.01

Pea and bean, succulent shelled, subgroup 6B, except pea

This subgroup includes 10 commodities.
bean, broad succulent • bean, lima succulent • cowpea • cowpea seed • pea, blackeyed • pea, english • pea, garden • pea, green • pea, pigeon • pea, southern

0.02
April 18, 2002 OPP-2002-0003

ISK - Establishment of an import tolerance for residues of fluazinam and its metabolite in or on wine grapes at 3.0 ppm. FINAL RULE.

  • 90-day oral toxicity rats: increased liver weights and liver histopathology in males, and increased lung and uterus weights in females.
  • 90-day oral toxiciity dogs: retinal effects, increased relative liver weight, liver histopathology and possible increased serum alkaline phosphatase in females and possible marginal vacuolation of the cerebral white matter (equivocal).
  • 21-Dermal toxicity rats: increased AST and cholesterol levels in clinical chemistry determinations (males)... erythema, acanthosis, and dermatitis.
  • Prenatal developmental toxicity rats: increased facial/ cleft palates, diaphragmatic hernia, and delayed ossification in several bone types, greenish amniotic fluid and possible increased late resorptions and postimplantation loss.
  • Prenatal developmental toxicity rabbits: increased liver histopathology... possible fetal skeletal abnormalities.
  • Reproductive and Fertility effects rats: liver pathology in F1 males.
  • Chronic toxicity rats: increased testicular atrophy in males
  • Chronic toxicity dogs: gastric lymphoid hyperplasia in both sexes
  • Carcinogenicitty mice: Clear evidence of carcinogenicity (hepatocellular tumors) in male mice, but not in females.
  • Combined chronic toxicity/carcinogenicity rats: liver toxicity in both sexes, pancreatic exocrine atrophy in females and testicular atrophy in males. Some evidence of carcinogenicity (thyroid gland follicular cell tumors) in male rats, but not in females.
  • Metabolism and pharmacokinetics rats: considerable enterohepatic circulation. According to Stedman's medical dictionary: circulation such as bile salts which are absorbed from the intestine and carried to the liver where they are secreted into the bile and again enter the intestine.
  • Special Study, 4-Week dietary (range-finding) rats: increased serum phospholipids, increased total cholesterol, increased relative liver weights, and liver histopathology.
  • Special Study, 4-Week dietary (range-finding) mice: increased serum glucose, increased kidney weights.
  • Special Study, 4-Week dietary (range-finding) mice: vacuolation of white matter in brain, increased liver weights, histopathology in liver.
  • Special Study, 90-Day (Special liver study) rats: increased relative liver weights and liver histopathology.
  • Special Study, 7-Day inhalation toxicity rats with Frowncide WP: increased testes weight (males) and increased liver weight (females).
  • 8 Special mechanistic studies to assess the CNS white matter vaculation: White matter vaculation in the CNS of mice, rats and dogs was found to be due to Impurity 5.
 
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