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fluometuron (Cotoran, Lanex) Herbicide Profile 12/85

                           CHEMICAL FACT SHEET FOR:
                                  FLUOMETURON
--  FACT SHEET NUMBER: 88
  DATE ISSUED: DECEMBER , 1985
                      1.  DESCRIPTION OF CHEMICAL
- Generic Name:  fluometuron (ANSI, WSSA, BSI, ISO)
- Trade Name:  Cotoran, Lanex
- EPA Shaughnessy Code:  035503
- Chemical Abstracts Service (CAS) Number:  2164-17-2
- Year of Initial Registration:  1960
- Pesticide Type:  herbicide
- Chemical Family:  substituted urea
- U.S. and Foreign Producers:  Ciba-Geigy, FBC Chemicals
                     2. USE PATTERNS AND FORMULATIONS
- Application sites:  To selectively control certain annual grasses
  and broadleaf weeds in cotton and sugarcane.
- Formulations:  Flowable liquid concentrate and wettable powder.
- Types and methods of application:  Postemergent directed or over-
  the-top spray, preplant soil incorporated, preemergent broadcast or
  banded spray, a directed layby treatment, and aerial application.
- Application rates:  Cotton 1.0 to 2 .0 lb. a.i./A with one to three
  applications per season, sugarcane 2.0 to 4.0 lb. a.i./A with one
  to two applications per season.
                            3 . SCIENCE FINDINGS
Chemical Characteristics
- Physical state:  Powder or crystals
- Color:  White to tan
- Odor:  Amine-like
- Melting point:  163 to 164.5
- Specific gravity or density:  1.40 g/cu. cm at 20 C
- Solubility (at 20 C):  In water, 105 ppm; acetone, 15%; chloroform,
  2%; methanol, 14%; and hexane, < 4%.
- Vapor pressure:  5 x 10 mmHg at 20 C
- Octanol/water partition coefficient:  PK = 3.2 at 20 C
- Stability:  Hydrolyzed by acid or base.  Stable at room
  temperature.
Toxicological Characteristics
- Acute effects:
  - Acute oral toxicity:  8.9 gm/kg in male rats, 7.8 gm/kg in female
    rats.Toxicity Category IV
  - Acute dermal toxicity:  3.03 gm/kg in rabbits, Toxicity Category III
  - Acute inhalation:  > 2.07 mg/l, Toxicity Category III
  - Primary eye irritation:  Induces corneal opacity, Toxicity
    Category I
  - Major routes of exposure:  Dermal and inhalation.
- Subchronic effects:
  - The NOEL for rats is 7.5 mg/kg.
  - The NOEL for dogs is 400 ppm.
- Chronic effects:
  - No adequate feeding studies are available to establish the
    chronic toxicity potential of technical fluometuron.
  - Oncogenicity:  data gap
  - Teratogenicity:  The compound is not teratogenic up to 500
    mg/kg.  No LEL can be established based on current data.
  - 2-generation reproduction:  data gap
  - Mutagenicity:  data gap
Physiological and Biochemical Behavioral Characteristics
- Metabolism:  data gap
Environmental Characteristics
- Preliminary adsorption and leaching characteristics:  Fluometuron
  is moderately to very mobile in a variety of soils ranging in
  texture from sand to silty clay loam.  These characteristics are
  not adequately understood.
- Resultant average persistence:  Fluometuron dissipates in sandy
  clay loam with a half-life of < 30 days (Europe).
Ecological Characteristics
- Hazards to birds:  Data are sufficient to characterize fluometuron
  as slightly to practically nontoxic to birds.
- Hazards to fish:  data gap
Tolerance Assessment
- List of crops and tolerances (CFR 40 180.229):  cottonseed at 0.1
  ppm, and sugarcane at 0.1 ppm.
- Results of tolerance assessment:  Tolerances cannot be adequately
  assessed until data gaps have been filled.
Summary Science Statement
- Fluometuron has been found to have many data gaps and to be a
  potential groundwater contaminant.
- Fluometuron is not acutely toxic in general.  However, it does
  produce some skin irritation and does induce corneal opacity.
          4.  SUMMARY OF REGULATORY POSITION AND RATIONALE
- Based on review and evaluation of all available data and other
  relevant information on fluometuron, the Agency has made the
  following determinations:
  - The available data are insufficient to indicate that any of the
    risk criteria listed in, Section 162.11(a) of Title 40 of the U.S.
    Code of Federal Regulations have been met or exceeded for the uses
    of fluometuron at the present time.
  - Fluometuron is a Toxicity Category I chemical regarding corneal
    opacity.  Skin irritation places fluometuron in Toxicity Category
    II.  However, the Agency has determined that the protective
    clothing required by this Standard will sufficiently reduce the
    risk associated with its use.
  - The absence of other toxicological data prevents the Agency from
    determining the subacute and chronic effects of fluometuron.
    Given the lack of data, the most appropriate action is to move
    quickly to fill the data gaps.  When data are submitted and
    reviewed, the Agency will determine the registerability of the
    affected use pattern.
  - Fluometuron tolerances for cotton and sugarcane will be reevaluated
    when the requested data in the Standard are received and reviewed.
    The data base supporting these tolerances is inadequate.  The data
    required to fill these data gaps are listed under number 5, Summary
    of Major Data Gaps, on this fact sheet.
  - Tolerances for fluometuron on meat, milk, poultry, and eggs have
    not been established; therefore, the label restrictions on feeding
    crop material to livestock will remain on product labeling.
  - Fluometuron has been placed on the list of possible groundwater
    contaminants, and the Agency has requested groundwater data on an
    accelerated basis under the data call-in program.
  - Use, formulation, or geographic restrictions:  Manufacturing-use
    products may only be formulated into end-use products intended for
    use as a herbicide on cotton and sugarcane.
  - Unique label warning statements:
    - Labels of all MP's must bear the statements:
      - Use pattern statement:  For formulation into end-use herbicide
        products intended for use on cotton and sugarcane.
      - Precautionary statements:  Do not contaminate water by cleaning
        of equipment or disposal of wastes.  Do not discharge effluent
        containing this product into lakes, streams, ponds, estuaries,
        oceans, or public waters unless this product is specifically
        identified and addressed in an NPDES permit.  Do not discharge
        effluent containing this product into sewer systems without
        previously notifying the sewage treatment plant authority.  For
        guidance, contact your State Water Board or Regional Office of
        the EPA.
      - Labels of EP's must bear the statements:
        - Hazards to humans statement:  Mixer/leader/applicators must
          wear protective clothing consisting of coveralls, a long-
          sleeved shirt, shoes, impermeable gloves, and eye protection
          when handling this product.
        - Environmental hazard statement:  The labels of EP's intended
          for outdoor use must bear one of the following statements.
          depending on the formulation of the product:
        - Granular products must bear the statement:  Do not apply
          directly to water or wetlands.  In case of spills, collect
          for use or properly dispose of the granules.  Do not
          contaminate water by cleaning of equipment or disposal of
          wastes.
        - Nongranular products must bear the statement:  Do not apply
          directly to water or wetlands.  Do not contaminate water by
          cleaning of equipment or disposal of wastes.
    - All products registered for use on:
      - Cotton:  Do not feed foliage from treated cotton plants or gin
        trash to livestock.  Do not apply within 60 days of cotton
        harvest.
      - Sugarcane:  Do not apply within 180 days of harvest.  Do not
        graze treated fields with livestock.
    - All products phytotoxicity warning:  Do not plant crops other
      than sugarcane or cotton within one year after the last
      application, or crop injury may result.
                     5.  SUMMARY OF MAJOR DATA GAPS
Data Requested                              Due Date (after issuance
                                            of Standard)
Product chemistry                           7 months
Magnitude of the residues, sugarcane        19 months
Magnitude of the residues cotton            19 months
Nature of residue (metabolism)              25 months
Hydrolysis                                  Study under review
Photodegradation, water and soil            Study under review
Metabolism - lab, aerobic soil and          Study under review
  anaerobic soil
Leaching and adsorption/desorption          Study under review
Soil dissipation, field                     Study under review
Accumulation, rotational crops              Study under review
21-day dermal                               13 months
Chronic toxicity                            50 months
Oncogenicity study                          50 months
Teratogenicity                              15 months
Reproduction                                39 months
Gene mutation                               9 months
Chromosomal aberration                      12 months
Other mechanisms of mutagenicity            12 months
General metabolism                          24 months
Freshwater fish, warmwater                  9 months
Foliar dissipation                          25 months
Soil dissipation                            25 months
Dermal exposure                             25 months
Inhalation exposure                         25 months
Analytical methods to verify                13 months
  certified limits
Submittal of samples                        7 months
Dermal sensitization and                    9 months
  photosensitization
                   6.  CONTACT PERSON AT EPA
Robert U. Taylor, PM-25
U.S. EPA
TS-767-C
401 M Street S.W.
Washington, DC  20460
709/557-1800
DISCLAIMER:
THE INFORMATION PRESENTED IN THIS CHEMICAL INFORMATION FACT SHEET
IS FOR INFORMATIONAL PURPOSES ONLY AND NOT TO BE USED TO FULFILL
DATA REQUIREMENTS FOR PESTICIDE REGISTRATION AND REREGISTRATION.