Section 1 - Chemical Product and Company

Transcription

1 1 of 7 Distributor: Sagent Pharmaceuticals, Inc N. Roselle Rd, Suite 700 Schaumburg, IL Section 1 - Chemical Product and Company Emergency Telephone: Product Identifier: Product Code: Common/Trade Name: Leucovorin Calcium, Folinic Acid, Citrovorum Factor Chemical Name: Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4- hydroxy-6-pteridinyl]methyl]amino]benzoyl]-l-glutamate (1:1) Chemical Family: Antianemic; antidote for folic acid antagonists Product Use: Pharmaceutical Product Type: Regulated Prescription Drug Container Information: Vials Section 2 - Composition / Information on Ingredients Ingredient Weight % CAS No. Leucovorin Calcium Sodium chloride < Water for Injection q.s Section 3 - Hazards Identification Primary Physical and Health Hazards: Routes of Entry: Signs & Symptoms of Exposure: Primary health effects anticipated in an occupational setting include irritation or eyes and skin as well as redness and local swelling after accidental injection. In case of over-exposure by injection, effects such as inflammation of the mouth and diarrhea may occur. Eye and skin contact, inhalation, ingestion and injection. Redness, irritation and allergy symptoms.

2 2 of 7 Chemical Listed as Carcinogen: Medical Conditions Generally Aggravated by Exposure: NTP: No IARC: No OSHA: No None currently known. Section 4 - First Aid Measures Eye Exposure: Skin Exposure: Ingestion: Injection: Inhalation: Notes to Physician: Contact may cause irritation. Effects may include stinging, watering and redness of the eyes. Flush eyes with large volumes of water for 15 minutes. Contact may cause irritation, redness, itching and a burning sensation on the skin. May cause allergic skin reaction. Wash skin with cool, soapy water. If ingestion occurs, flush mouth with water and seek medical attention immediately. If person is conscious and medical assistance is not available, induce vomiting. Never induce vomiting on an unconscious person. Local redness and pain are the primary symptoms of accidental injection in an occupational setting. Medical personnel are not anticipated to experience over-exposure to the therapeutic doses of this product. However, effects including inflammation of the mouth and diarrhea may occur. See package insert for other adverse reactions associate with therapeutic doses of this product. If difficulty breathing, administer oxygen. Seek attention of a physician immediately. If necessary, provide artificial respiration. See patient package insert in shipping carton for complete information. Section 5 - Fire Fighting Measures Flash Point: Auto-ignition Temperature: Flammable Limits in Air: Flammable Limits: Not established Not established Lower %: Not established Upper %: Not established Not established

3 3 of 7 Extinguishing Media: Special Fire Fighting Procedures: Unusual Fire/Explosion Hazards: Use water or an ABC multi-purpose extinguisher. As with all fires, evacuate persons to a safe area. Fire fighters should wear self-contained breathing apparatus to avoid smoke inhalation. None. Section 6 - Accidental Release Measures Spill: Release to Air: Release to Water: Lightly wet Leucovorin Calcium with water and absorb in absorbent materials. Dispose of according to local, state and federal guidelines. If dust is generated, reduce exposure by ventilating area; clean up spills immediately to prevent dusting. Refer to local water authority. Drain disposal is not recommended; refer to local, state, and federal disposal guidelines. Section 7 - Handling and Storage General Handling: Waste Disposal Method: Storage Conditions: Wear latex or nitrile gloves and safety glasses when cleaning up spills. A dust/mist respirator (N95) may be necessary if airborne dust is generated. Incineration in an approved incinerator is recommended. Refer to local, state and federal guidelines. Store dry product and reconstituted solution at C (68-77 F). Excursions permitted between C (59-86 F) [See USP Controlled Room Temperature.] Protect from light, store in carton until time of use. Follow instructions provided in packaging. Section 8 - Exposure Controls / Personal Protection Respiratory Protection: Eye Protection: Ventilation: Under normal use, respirators are not required. If dusts are generated, a disposable dust/mist respirator (N95) may be used. Personnel wearing respirators should be fit tested and approved for respirator use under the OSHA Respiratory Protection Standards 29 CFR Safety glasses or goggles Handle product in a well-ventilated area.

4 4 of 7 Skin Protection: Other Protective Equipment: Additional Exposure Precautions: Latex or nitrile gloves None Wash hands following use. No eating, drinking or smoking while handling this product. Exposure Limits Compound Issuer Type OEL Leucovorin Calcium OSHA ACGIH PEL TLV Sodium Chloride OSHA ACGIH PEL TLV Water for Injection OSHA ACGIH PEL TLV Section 9 - Physical and Chemical Properties Physical State: Lyophilized powder Specific Gravity: 1 Appearance and Odor: Yellow-white Evaporation Rate: Not applicable powder, odorless Boiling Point: Not applicable Melting Point: Not applicable Vapor Pressure: Not applicable Solubility in Water: Very soluble Vapor Density: Not applicable ph: 6.5 and 8.5 Molecular Weight:

5 5 of 7 Section 10 - Stability and Reactivity Stability: Incompatibility (Materials to avoid): Hazardous Decomposition: Hazardous Polymerization: Conditions to Avoid: Stable Strong oxidizers When heated, decomposition products of this chemical may include potentially hazardous by products of nitrogen oxides, carbon monoxide, and carbon dioxide. Will not occur Contact with strong oxidizers Section 11 - Toxicological Information Signs & Symptoms of Exposure: Redness, irritation and allergy symptoms. Acute Toxicity Component Type Route Species Dosage Leucovorin Calcium LD 50 Intravenous Mouse 732 mg/kg Leucovorin Calcium LD 50 Oral Rat >8 gm/kg Leucovorin Calcium LD 50 Oral Mouse >7 gm/kg Leucovorin Calcium LD 50 Intraperitoneal Mouse 1036 mg/kg Leucovorin Calcium LD 50 Intraperitoneal Rat 1063 mg/kg No applicable ecological information found. Section 12 - Ecological Information

6 6 of 7 Section 13 - Disposal Considerations Waste Disposal: Dispose of by incineration at an approved/permitted incinerator. Review local, state and federal regulations for your regulatory area. Regulatory Organizations: DOT: Not Regulated ICAO/IATA: Not Regulated IMO: Not Regulated Section 14 - Transport Information Section 15 - Regulatory Information Below is selected regulatory information chosen primarily for possible Sagent usage. This section is not a complete analysis or reference to all applicable regulatory information. Please consider all applicable laws and regulations for your country/state. U.S. Regulations RCRA - No CERCLA - Not on this list SARA Not on this list SARA 302 Not on this list TSCA - No Section 16 - Other Information As of the date of issuance, we are providing available information relevant to the handling of this material in the workplace. All information contained herein is offered with the good faith belief that it is accurate. THIS MATERIAL SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE ANY WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY OR FITSS FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this material, this safety data sheet is not intended to be a substitute for consultation with appropriately trained personnel. Nor is this safety data sheet intended to be a substitute for product literature which may accompany the finished product. For additional information contact: Sagent Pharmaceuticals, Inc N. Roselle Rd, Suite 700 Schaumburg, IL

7 7 of 7 Glossary: This glossary contains definitions of general terms used in MSDSs. Not all of these Glossary Terms will apply to this MSDS. ACGIH American Conference of Governmental Industrial Hygienists AIHA American Industrial Hygiene Association CAS Chemical Abstract Service Registry Number Number CERCLA Comprehensive Environmental Response Compensation and Liability Act (of 1980) CHAN Chemical Hazard Alert Notice CHEMTREC Chemical Transportation Emergency Center DOT Department of Transportation EPA Environmental Protection Agency HEPA High Efficiency Particulate Air (Filter) IARC International Agency for Research on Cancer ICAO/IATA International Civil Aviation Organization/International Air Transport Association IMO International Maritime Organization KOW Octanol/Water Partition Coefficient LEL Lower Explosive Limit MSDS Material Safety Data Sheet MSHA Mine Safety and Health Administration NA Not Applicable, except in Section 14 where NA = North America Not Established NADA New Animal Drug Application NAIF No Applicable Information Found NCI National Cancer Institute NIOSH National Institute for Occupational Safety and Health NOS Not Otherwise Specified NTP National Toxicology Program OSHA Occupational Safety and Health Administration OEL Occupational Exposure Limit PEL Permissible Exposure Limit (OSHA) RCRA Resource Conservation and Recovery Act RQ Reportable Quantity RTECS Registry of Toxic Effects of Chemical Substances SARA Superfund Amendments and Reauthorization Act Short Term Exposure Limit TLV Threshold Limit Value (ACGIH) TPQ Threshold Planning Quantity TSCA Toxic Substances Control Act TWA Time Weighted Average/8 Hours Unless Otherwise Noted UEL Upper Explosive Limit UN United Nations USP United States Pharmacopeia WEEL Workplace Environmental Exposure Level (AIHA)