United Statet office of Pettictdes ind Toxic Sufaaanc** Environmental Protection OHica of Pestidde Programs (TS-766C) Agency Washington. DC 20460 &EPA Pesticide Fact Sheet Name of Chemical: 0^^^ (Alar) Reason for Issuance: Date Issued: June 30, 1984 Fact Sheet Number: 26 Description of Chemical Common Name: Daninozide Chemical Name: Butanedioic acid mono(2,2-dimethylhydrazine), Succinic acid 2,2-dimethylhydrazide Trade Name: 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 Chemical Family: Amino Acid Derivative U.S. and Foreign Producers: Dniroyal and Aceto Chemical Dse 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 aaminozide that is applied as a field spray ranges firoic C.9 to 6.8 pounds active ingredient per acre per year, depending of tne 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. Scientific Findings o Summary Science Statement 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 UDMB contaminant cause oncogenic effects. A tolerance reassessment cannot be performed at this time. Daminozide leacnes from soil, but is not persistent. Daisinozide is net an acute toxicant to fish and wildlife. ------- o Chemical Characteristics Daminozide is a white, crystalline solid with slight to no odor. Daminozide is soluble in water, methanol and aceto- nitrile, but insoluble in zylene and aliphatic nydrocarbon3. DaminOzide has a melting point range from 154 to 156°:. Technical daminozide contains at least 99 percent active ingredient. o Toxicological Characteristics The LD5O and Toxicity Categor s for daminozide are: acute oral C 8.4 g/k;, IV ), acute dermal ( >16 g/kg, III), acute inhalation (>l4 mg/kg, IV), primary eye irritation (mild, none at this time), derma] irritation (mild, IV). Daminozide does not produce mutagenic or teratogenic effects. Data are insufficient to )udge the effects of daminozide on reproduction. Daminozide causes oncogenic effects in laboratory animals. o 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 UDPIH metabolite down to 1 ppb must be validated to confirm the presence of UDMB 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. o Environmental Characteristics Degrades in water to unsymmetrical 1,l—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 ground water contamination is small. Daminozide does not bioconcentrate in fish nor does it accumulate in rotational crops. o 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. o Tolerance Assessment A final reassessment of all tolerances cannot be made at this time until the data gaps specified by the Standard are filled. ------- o Problems with Use Extended storage of solutions of daminozide result in excessive hydrolysis of the active ingredient to UDMH. Regu].atov Position & Rationale o Use C].asiification Daminozide is classified as a General Us.. pesticide. o Use Restrictior.s None. o Unique Warning Statements Solutions of daminozide must be used within 24 hours after preparation. o 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 tne 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. o Risk Analysis Significant exposure to darninozide and UDMB can occur via consumptior of raw and processed agricultural commodities treated witn 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. o Special Review Registrants of daminozide products are notified, via the Guidance Document, that daminozide meets the oricogenicity 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. 3 ------- Summary of Major Data Gaps Data gaps and time (in months) allowed to perform studies: toxicology (cnronic testing [ 48], teratology [ 12], reproduction [ 24], generil metabolism [ 12] and rnutagenicity (6]), product chemistry (product identity, analysis and certification of product ingredients, physical and chemical characteristics) 16], environmental fate (degradation [ 6], photodegradation [ 6], metabolism [ 24], mobility [ 6], dissipation (24], accumulation (24] and reentry 124], residue chemistry (metabolism in plants and animals 12], analytical methods and residue data (12], residue data [ 1’2)), and.ecblogical effects (avian and mammalian testing and aquatic organism testing) (48]. 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 may not be used to fulfill data requirements for pesticide registration and reregistration. ------- |