MATERIAL SAFETY DATA SHEET SECTION 1 - IDENTIFICATION OF PRODUCT AND COMPANY Phibro Animal Health 65 Challenger Road Ridgefield Park, NJ 07660 Emergency telephone: Hours of operation: Product Information: Hours of operation 1-800-345-4735 24 Hours 1-888-475-7355 M-F 9 a.m. - 5 p.m. Eastern Time Trade names STAFAC 500; STAFAC 50; STAFAC 20; STAFAC 10, STAFAC 150, V-Max, STAFAC 22, STAFAC 44, STAFAC 2.2% Therapeutic use Description Antibiotic agent Brown granulated powder with characteristic fermentation odor and very bitter taste SECTION 2 - COMPOSITION Ingredient CAS Number Amount Virginiamycin 11006-76-1 <50% Inert Material Proprietary SECTION 3 - HAZARDS IDENTIFICATION Signal word Statements of hazard Eye effects Skin effects Inhalation effects Ingestion effects Known clinical effects Dust may cause irritation. Dust may cause irritation. Dust may cause irritation. See 'Known clinical effects', below. May cause effects similar to those generally seen in clinical use of antibiotics including gastrointestinal irritation, vomiting, transient diarrhea, nausea, and abdominal pain. Revision date: 03/14/06, Printed: 3/14/06 Page 1 of 6
SECTION 4 - FIRST AID MEASURES Skin Eyes Inhalation Ingestion Wash skin with soap and water. Remove contaminated clothing and shoes. Wash clothing and thoroughly clean shoes before reuse. If irritation occurs or persists, get medical attention. Immediately flush eyes with water for at least 15 minutes. If irritation occurs or persists, get medical attention. Remove to fresh air. If not breathing, give artificial respiration. Get medical attention immediately. Get medical attention immediately. Do not induce vomiting unless directed by medical personnel. Never give anything by mouth to an unconscious person. SECTION 5 - FIRE FIGHTING MEASURES Fire fighting instructions Extinguishing media Flash point Hazardous combustion products Wear approved positive pressure, self-contained breathing apparatus and full protective turn out gear. Evacuate area and fight fire from a safe distance. Use carbon dioxide, dry chemical, or water spray. Emits toxic fumes of carbon monoxide, carbon dioxide and oxides of nitrogen SECTION 6 - ACCIDENTAL RELEASE MEASURES General Small spill Large spill Review Sections 3, 8 and 12 before proceeding with clean up. Vacuum or sweep material into appropriate recovery container. Clean spill area thoroughly. Vacuum or sweep material into appropriate recovery container. Close container and move it to a secure holding area. SECTION 7 - HANDLING AND STORAGE General handling Storage conditions Minimize dust generation and accumulation. Use only in a well-ventilated area. Avoid contact with eyes, skin and clothing. Avoid breathing dust. Store out of direct sunlight in a cool, well ventilated dry area. Protect from light. Keep container tightly closed when not in use. Revision date: 03/14/06, Printed: 3/14/06 Page 2 of 6
SECTION 8 - EXPOSURE CONTROLS/PERSONAL PROTECTION Exposure limits Compound Issuer Type OEL Virginiamycin Phibro TWA-8 HR 3 mg/m³ Liquid paraffin ACGIH Ceiling 10 mg/m³ (oil mist) ACGIH TWA-8 HR 5 mg/m³ OSHA TWA-8 HR 5 mg/m³ Croscarmellose sodium ACGIH TWA-8 HR 10 mg/m³ (total dust) OSHA TWA-8 HR 5 mg/m³ (respirable dust) OSHA TWA-8 HR 15 mg/m³ (total dust) Calcium carbonate ACGIH TWA-8 HR 10 mg/m³ (particulate) Ventilation Respiratory protection Eye protection Skin protection Hand protection Engineering controls should be used as the primary means to control exposures. Good general ventilation should be sufficient to control airborne levels. For laboratory use, handle in a lab hood. In dusty conditions use an approved dust mask or more protection as needed. If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL. Wear safety glasses with sideshields if airborne dust is present. If dust is created wear long sleeves and pants to protect skin. Rubber gloves SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES Physical form Color Odor Taste Molecular weight Molecular formula ph Boiling point Melting point Density Vapor pressure Water solubility Solvent solubility Powder Brown granulated powder Fermentation odor Bitter Mixture Mixture Insoluble Revision date: 03/14/06, Printed: 3/14/06 Page 3 of 6
SECTION 10 - STABILITY AND REACTIVITY Reactivity Conditions to avoid Incompatibilities Hazardous decomposition products Hazardous polymerization Stable at temperatures below 93 C (200 F) High temperatures None known Will not occur SECTION 11 - TOXICOLOGY INFORMATION Toxicology summary The information included in this section describes the potential hazards of the active ingredient. Acute toxicity Compound Type Route Species Dosage Virginiamycin LD 50 Oral Dog > 4,000 mg/kg LD 50 Oral Mouse > 5,000 mg/kg LD 50 Oral Rat 10,000 mg/kg Eye Skin Inhalation Ingestion Mutagenicity Subchronic effects Chronic effects/ carcinogenicity Carcinogen status See table above Virginiamycin was not mutagenic in microbial cells, but was weakly positive in in vitro mammalian cells. Overall, it is unlikely to be a true genotoxin. Virginiamycin was evaluated in rats for three months and in dogs for 3 to six months at doses up to 100mg/kg/day. No significant drug-related effects were seen at any dose level in either species. In a six month study of dogs at higher dose levels the NOEL was established at 200 mg/kg/day. In a long-term oral toxicity study mice were fed doses up to 100 mg/kg/day and no drug related effects were observed. The NOEL for toxicity and carcinogenicity in this study were determined to be 1000 mg/kg/day. In a long-term oral toxicity study rats were fed doses up to 300 mg/kg/day. At dose levels greater than 50 mg/kg/day reduced body weight and increased food consumption was noted. Some changes in clinical chemistry parameters were observed in males, but not females. The toxicity NOEL for this study was established at 50 mg/kg/day and the carcinogenicity for this study was determined to be 300 mg/kg/day. Not listed as a carcinogen by IARC, NTP or US OSHA. Revision date: 03/14/06, Printed: 3/14/06 Page 4 of 6
SECTION 11 - TOXICOLOGY INFORMATION...continued Reproductive effects Teratogenicity At increased risk from exposure In a two-generation study in rats, no treatment-related reproductive effects were observed at doses up to 100 mg/kg/day. No treatment-related teratogenic effects were observed in rats or mice at doses up to 200 or 1000 mg/kg/day, respectively. Individuals with a known history of hypersensitivity to this material or other materials in its chemical class may be more susceptible to toxicity in cases of overexposure. SECTION 12 - ECOLOGICAL INFORMATION Environmental overview Mobility, persistence, and degradability: Bioaccumulation and toxicity: Log P (octanol/water partition coefficient) In the environment, this substance can be expected to bind to soil and sediment and degrade rapidly. No harmful effects to aquatic organisms are expected. This substance binds to soil and sediment,degrades rapidly, and does not persist. Low acute toxicity to aquatic organisms is expected. This material has low potential to bioaccumulate (based on animal data) and long-term adverse effects to aquatic organisms are not expected. >7.35@25 C, ph 7 (virginiamycin) SECTION 13 - DISPOSAL INFORMATION Disposal procedure Incineration is the recommended method of disposal for this material. Observe all local and national regulations when disposing of this material. SECTION 14 - TRANSPORTATION INFORMATION General shipping instructions Not regulated SECTION 15 - REGULATORY INFORMATION TSCA status SARA section 302 SARA section 313 Not listed No No Revision date: 03/14/06, Printed: 3/14/06 Page 5 of 6
SECTION 15 - REGULATORY INFORMATION continued California Proposition 65 Canadian WHMIS Not listed This product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the information required by the CPR. SECTION 16 - OTHER Disclaimer Phibro Animal Health believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without a warranty of any kind, expressed or implied. Revision date: 03/14/06, Printed: 3/14/06 Page 6 of 6