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daminozide (Alar, B-Nine) Growth Regulator Profile 6/86

                         CHEMICAL FACT SHEET FOR:
                               DAMINOZIDE
FACT SHEET NUMBER: 26
DATE ISSUED: JUNE 30, 1986
                     1.  DESCRIPTION OF CHEMICAL
- Common Name:  daminozide
- Chemical Name:  Butanedioic acid mono(2,2-dimethylhydrazine),
  Succinic acid 2,2-dimethylhydrazide
- Trade Names:  Alar, Kylar, SADH, B-nine, B-995, aminozide
- EPA Shaughnessy Code:  035101
- Chemical Abstracts Service (CAS) Number:  1596-84-5
- Pesticide Type:  Plant growth regulator
- Pesticide Family:  Amino acid derivative
- U.S. and Foreign Producers:  Uniroyal and Aceto Chemical
                   2.  USE PATTERNS AND FORMULATIONS
- Daminozide is a plant growth regulator registered as a 5 percent water
  soluble liquid or 85 percent water soluble dry concentrate
  formulation.  The amount of daminozide that is applied as a field
  spray ranges from 0.9 to 6.9 pounds active ingredient per acre per
  year, depending on the crop, time of application, and desired effects.
  Daminozide controls the vegetative and reproductive growth of orchard
  crops such as apples, cherries, nectarines, peaches, prunes, and
  pears.  In addition, daminozide use enhances shorter and more erect
  peanut vines or modifies the stem length and shape of ornamental
  plants.  Other minor uses of daminozide include:  Brussels sprouts
  (California), cantaloupes (California and Arizona), grapes, and
  tomatoes.
                      3.  SCIENTIFIC FINDINGS
Chemical Characteristics
- Daminozide is a white, crystalline solid with slight to no odor.
- Daminozide is soluble in water, methanol, and acetonitrile, but
  insoluble in xylene and aliphatic hydrocarbons.  Daminozide has a
  melting point range from 154 to 156 degrees C.  Technical daminozide
  contains at least 99 percent active ingredient.
Toxicological Characteristics
- The LD50 and Toxicity Categories for daminozide are:  acute oral (8.4
  g/kg, IV), acute dermal (>16 g/kg, III), acute inhalation (>147 mg/kg,
  IV), primary eye irritation (mild, none at this time), dermal
  irritation (mild, IV).  Daminozide does not produce mutagenic or
  teratogenic effects.  Data are insufficient to judge the effects of
  daminozide on reproduction.  Daminozide causes oncogenic effects in
  laboratory animals.
Physiological and Biochemical Behavioral Characteristics
- Data indicate that daminozide is rapidly absorbed through the leaves,
  roots, and stems.  Daminozide is translocated in plants and can
  accumulate in roots, fruit, etc.  Adequate methods are available to
  detect daminozide.  A method to detect the UDMH metabolite down to 1
  ppb must be validated to confirm the presence of UDMH residues in
  plants.  Components of the final residues have not been adequately
  identified or quantified.  The majority of daminozide residues
  ingested by milk animals is rapidly excreted in the urine and feces.
Environmental Characteristics
- Degrades in water to unsymmetrical 1,1-dimethylhydrazine (UDMH), a
  known oncogen.  Daminozide appears to resist photodegradation, but is
  degraded by soil microorganisms.  Daminozide appears to leach, but
  since it does not persist in soil, the potential for groundwater
  contamination is small.  Daminozide does not bioconcentrate in fish,
  nor does it accumulate in rotational crops.
Ecological Characteristics
- Daminozide has low acute toxicity to fish and terrestrial wildlife.
  No data are available to assess the ecological hazard from the UDMH
  hydrolysis product/contaminant.  Problems with Endangered Species:
  None known at this time.
Tolerance Assessment
- A final reassessment of all tolerances cannot be made at this time
  until the data gaps specified by the Standard are filled.
Problems With Use
- Extended storage of solutions of daminozide result in excessive
  hydrolysis of the active ingredient to UDMH.
Science Summary Record
- Daminozide is a white, water soluble solid.  Data indicate that
  daminozide has low acute toxicity, low dermal irritation potential,
  and is neither teratogenic nor mutagenic.  Daminozide and its UDMH
  contaminant cause oncogenic effects.  A tolerance reassessment cannot
  be performed at this time.  Daminozide leaches from soil, but is not
  persistent.  Daminozide is not an acute toxicant to fish and wildlife.
               4.  REGULATORY POSITION AND RATIONALE
- Use Classification:  Daminozide is classified as a General Use
  Pesticide.
- Use Restrictions:  None.
- Unique Warning Statements: Solutions of daminozide must be used
  within 24 hours after preparation.
- Benefit Analysis: Approximately 825,000 pounds of daminozide are
  produced annually, with apples and peanuts accounting for 600,000
  pounds and 225,000 pounds of the annual usage, respectively.  Without
  daminozide, short-term revenue losses are projected to range up to $30
  million annually for apples and from $4.3 to $10.7 million annually
  for peanuts.
- Risk Analysis: Significant exposure to daminozide and UDMH can occur
  via consumption of raw and processed agricultural commodities treated
  with daminozide.  The Agency's preliminary estimate of oncogenic
  dietary risk for daminozide is high.  There are insufficient data to
  quantify the oncogenic dietary risk of UDMH at this time.  The
  oncogenic nondietary risk for daminozide and UDMH may not be
  significant.
- Special Review: Registrants of daminozide products are notified, via
  the Guidance Document, that daminozide meets the oncogenicity risk
  criterion in 40 CFR 162.11(a) and will undergo a Special Review.  The
  Agency will not reregister any current products, and it will not
  register any new products containing daminozide until Special Review
  is completed and the Agency has received commitment to fulfill data
  requirements.
                    5.  SUMMARY OF MAJOR DATA GAPS
- Data gaps and time in months allowed to perform studies: toxicology
  (chronic testing - 48, teratology - 12, reproduction - 24, general
  metabolism - 12, and mutagenicity - 6), product chemistry (product
  identity, analysis and certification of product ingredients, physical
  and chemical characteristics) - 6, environmental fate (degradation -
  6, photodegradation - 6, metabolism - 24, mobility - 6, dissipation -
  24, accumulation - 24, and reentry - 24, residue chemistry (metabolism
  in plants and animals - 12, analytical methods and residue data - 12,
  residue data - 12), and ecological effects (avian and mammalian
  testing and aquatic organism testing - 48).
                        6.  CONTACT PERSON
Robert Taylor, PM 25
Registration Division (TS-767C)
Environmental Protection Agency
401 M Street, SW
Washington, D.C. 20460
(703) 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.
 

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