United States Office of Pesticides and Toxic Substances Environmental Protection Office of Pesticide Programs (TS-766C) Agency Washington. DC 20460 Pesticide Fact Sheet Name of Chemical: LACTIC ACID Reason for Issuance: NEW CHFMICAL REGISTRATION Date Issued: APR 2 9 1988 Fact Sheet Number: 163 Description of Chemical Common Name: Lactic acid Chemical Name: 2-Hydroxypropanoic acid Trade Names: propel, SY-83 OPP (Shaughnessy) Number: 128929 Chemical Abstracts Service (CAS) Number: 79-33-4 * Empirical Formula: C3Hg03 Molecular Weight: 90.08 Year of Initial Registration: 1988 Pesticide Type: Plant growth regulator U.S. Producer: Purac Inc. Use Patterns and Formulations Types of Effects: Lactic acid hastens ripening, increases fruit, seed and pod set and increases shoot and root initiation. « Application Sites: Almonds, apples, beans (green and dry), broccoli, cabbage, cauliflower, cherries, citrus, corn (sweet and field), cotton, grapes, lettuce, peppers (green and chil^), pineapples, prunes, strawberries, sugarcane, tomatoes and walnuts. Types and Methods of Application: Applied by conventional aerial or ground equipment to foliage. Application Rates: Rates range from 1 to 4 pounds active ingredient (ai)/acre. A-100&-2000 parts per million (ppm) solution will be used for pineapple and sugarcane planting materials. ------- —2 Type of Formulation: 80% ai solution Usual Carriers: Water 3. Science Findings Summary Science Statement: Available acute toxicity data indicate Toxicity Category I for lactic acid, based on pH. Lactic acid is a severe dermal and eye irritant. However, acute dermal data indicate no systemic toxicity. Protective clothing and eye protection statements are required on the label to minimize exposure during mixing, loading and application operations. Subchronic/chronic toxicity, mutagenici ty and environmental fate data requirements are waived. The use of lactic acid is not expected to cause adverse effects to nontarget organisms including endangered species. The chemical is exempted from the requirement of a tolerance when used as a plant growth regulator in or on all raw agricultural commodities (RAC). Chemical Characteristics Physical State: Nonvolatile liquid Color: Colorless Odor: Odorless to weakly acid Boiling Point: 190 C (760 mm Hg) Density: 1.195 (at 85.3% purity) grams/ml Solubility (25 C): Water — infinite Ether — infinite Ethanol — infinite Vapor Pressure: 1.3 mm Hg at 90 C Dissociation Constant: pKa = 3.87 pH: 0.6 Stability: Material is stable at normal temperatures. Toxicological Characteristics: Acute toxicity results Acute oral toxicity (rat): 4,936 mg/kg (male), 3,543 mg/kg (female), Toxicity Category III ------- —3— Acute dermal toxicity (rabbit) : greater than 2,000 mg/kg, Toxicity Category III Acute inhalation toxicity (rat) : greater than 5.0 mg/i (analytical concentration) and 7.94 mg/i (nominal concentration) for each sex separately or combined. Toxicity Category III Primary dermal irritation (rabbit): Lactic acid is a severe dermal irritant. Toxicity Category I Primary eye irritation: This data requirement was not required since the pH of the chemical is less than 2. Toxicity Category I is assigned because of the low pH. Dermal sensitization (guinea pig): Lactic acid is not a dermal sensitizer. Subchronic, chronic toxicity and mutagenicity data requirements are waived. These waivers are based on the following, (1) the natural occurrence of lactic acid; (2) residues resulting from the registered uses will not be higher than is presently allowed in food production and (3) such residues will not exceed normal physiological lactic acid levels in raw agricultural commodities (RACs) Major Routes of Exposure: Mixers, loaders and applicators would receive the most exposure via skin/eye contact and inhalation. Physiological and Biochemical Behavioral Characteristics: Mechanism of pesticidal action: Preliminary research indicates that lactic acid causes temporary stimulation of the Krebs cycle after glycolysis. Metabolism and persistence in plants and animals: Lactic acid is a normally occurring compound in both plants and animals. It is formed and metabolized from/to pyruvic acid in glycolysis. Environmental Characteristics: Lactic acid is naturally occurring and is rapidly formed and degraded in soil. The chemical is found in root exudates of common vegetables. It is a product of aerobic and anaerobic soil metabolism of glucose and plant matter. Because of the volume of data available on this compound and its natural occurrence in the environment, the environmental fate data requirements are waived. ------- -4- Ecological Characteristics: Avian acute oral toxicity (bobwhite quail): greater than 2,250 mg/kg Avian dietary toxicity (bobwhite quail): greater than 5,620 ppm Avian dietary toxicity (mallard duck): greater than 5,620 ppm Fish acute toxicity (bluegill) : 130 ppm Fish acute toxicity (rainbow trout) : 130 ppm Aquatic invertebrate toxicity ( Daphnia magna ) : 750 ppm potential problems related to endangered species: Minimal hazard to endangered species is expected from the proposed use of lactic acid due to the chemical’s natural occurrence in the environment and living organisms and its low toxicity. Tolerance Assessment: Lactic acid (2—Hydroxypropanoic acid) is exempted from the requirement of a tolerance when used as a plant growth regulator in or on all raw agricultural commodities (RAC). Lactic acid is approved for use as an inert ingredient for application to plants (40 CFR 180.1001 (c)). The Food and Drug Administration approved the use of lactic acid as a generally recognized as safe (GRAS) ingredient in human foods. No Mexican or Canadian tolerances or Codex Alimentarius maximum residue limits have been established for residues of lactic acid in any RAC. 4. Summary of Regulatory Positions The following Agency positions are summarized from the Lactic Acid Registration Standard. None of the risk criteria listed in 40 CFR 154.7 for initiating a Special Review has been exceeded. The Agency is requiring protective clothing and eye protection. The Agency has waived the subchronic, chronic and mutagenicity data requirements. The Agency has waived environmental fate data requirements for lactic acid. ------- —5— Use, Formulation or Geographic Restrictions: None Unique Label Warning Statements: protective clothing and eye protection are required. 5. Summary of Major Data Gaps None 6. Contact person at EPA Robert 3’. Taylor U.S. Environmental Protection Agency Registration Division (TS—767C) 401 M Street., S.W. Washington, D.C. 20460 (703) 557—1800 DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational purposes only and may not be used to fulfill data requirements for pesticide registration and reregistration. ------- |