Material Safety Data Sheet - Cardinal Health

1 Material Safety Data Sheet MSDS Number:1087957 Revision date:09/02/2003 Print date:09/02/2003 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION MSDS Number:1087957 Product name:Nitroglycerin in 5% Dextrose InjectionProduct code:1A0692, 1A0694, 1A0696, JA0694, NDC 0338-1047-02, NDC 0338-1049-02, NDC 0038-1051-02 Synonyms:NoneChemical Family:Cardiovascular drugProduct Type:Regulated Prescription DrugContainer Information:250 ml glass containerProduct Use:Pharmaceutical Supplier:BAXTER HEALTHCARE CORPORATION DEERFIELD, ILLINOIS 60015 (800) 422-9837 or (847) 948-4770 Emergency telephone number:PROSAR: USA (888) 990-0996 OUTSIDE USA (615)917-6114 CHEMTREC: USA (800) 424-9300 OUTSIDE USA (743)741-6089 2. COMPOSITION/INFORMATION ON INGREDIENTS ComponentWeight %UN Number:Classification:Nitroglycerin (desensitized); UN0144 (solution in alcohol with more than 1 percent but not more than 10 percent nitroglycerin); UN1204 (solution in alcohol with not more than 1 percent nitroglycerin); UN3064 (solution in alcohol with more than 1 percent but not more than 5 percent nitroglycerin); UN3319 (desensitized, solid); UN3343 (mixture, desensitized, liquid, flammable)E;R3 N;R51-53 R33 T+;R26/27/28 Dextrose 5996-10-15 NoneNoneEthyl Alcohol 64-17-5<1UN1170F;R11 Citric Acid Anhydrous 77-92-9<1 NoneXi; R38 Water 7732-18-5>94 NoneNone 3.

2 HAZARDS IDENTIFICATION Emergency overview:Product contains no specific hazards other than therapeutic effects. Principle routes of exposure:Absorbed through skin. Eye contact. id: 1087957_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Product name: Nitroglycerin in 5% Dextrose Injection Inhalation:Inhalation not likely under normal use conditions. Ingestion:Nervous system effects (headache, dizziness, light headedness). Cardiovascular effects (may include fluctuations in heart rate, changes in blood pressure, chest pain). Skin contact:Nervous system effects (headache, dizziness, light headedness). Cardiovascular effects (may include fluctuations in heart rate, changes in blood pressure, chest pain).

3 Eye contact:No known effect according to our database. 4. FIRST AID MEASURES Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention if symptoms appear. Skin contact:Wash contaminated skin with soap and water. Get medical attention if irritation develops. Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this Material are swallowed, call a physician immediately. Eye contact:In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation develops. Notes to physician:See patient package insert in shipping carton for complete information.

4 5. FIRE FIGHTING MEASURES Suitable extinguishing media:Use foam or all purpose dry chemicals to extinguish. Special protective equipment for firefighters:Fire fighters should wear positive pressure self-contained breathing apparatus (SCBA) and full turnout gear. Specific methods:No information availableFlash point:Not determinedAutoignition temperature:Not applicableFlammable limits in air-lower (%):Not applicableFlammable limits in air-upper (%):Not applicable 6. ACCIDENTAL RELEASE MEASURES Personal precautions:Use suitable protective equipment (Section 8). Follow all fire fighting procedures (Section 5). Environmental precautions:No information available. Methods for cleaning up:If emergency personnel are unavailable, contain spilled Material . For small spills add absorbent (soil may be used in the absence of other suitable materials) scoop up Material and place in a sealed, liquid-proof container for disposal.

5 For large spills dike spilled Material or otherwise contain Material to ensure runoff does not reach a waterway. Place spilled Material in an appropriate container for disposal. Product id: 1087957_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Product name: Nitroglycerin in 5% Dextrose Injection 7. HANDLING AND STORAGE Handling: Technical measures/precautions:Do not ingest. Wash thoroughly after handling. Storage: Technical measures/storage conditions:Keep containers tightly closed in a cool, well-ventilated place. Store at room temperature 25 C (77 F). Protect from freezing. Avoid excessive heat. Incompatible products:No special restrictions on storage with other products. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Occupational Exposure Limits ComponentOSHA- Time Weighted Average:OSHA- Short Term Exposure Limit:OSHA- Ceiling LimitsACGIH- Time Weighted Average:ACGIH- Short Term Exposure Limit:ACGIH- Ceiling Limit Value:Nitroglycerin ppm Ceiling; 2 mg/m ppm TWANoneNoneDextrose 5996-10-1 NoneNoneNoneNoneNoneNoneEthyl Alcohol 64-17-51000 ppm TWA; 1900 mg/m TWANoneNone1000 ppm TWANoneNoneCitric Acid Anhydrous 77-92-9 NoneNoneNoneNoneNoneNoneWater 7732-18-5 NoneNoneNoneNoneNoneNone Engineering measures:No special containment is required.

6 Provide general or local exhaust ventilation. Personal protective equipment: Respiratory protection:Perform exposure monitoring for this product and its components to ensure that employees are not exposed to levels greater than applicable regulatory limits. If exposure levels exceed regulatory limits, implement a respiratory protection program including respiratory protection that is in compliance with OSHA 29 (in the US) or equivalent regulation in other regions. Fire fighting requires the use of a self-contained breathing apparatus with full face piece and positive pressure mode. Hand protection:Use chemical resistant, impervious gloves. Skin and body protection:Work uniform or laboratory coat. Additional body garments should be used based upon the task being performed ( , sleevelets, apron, gauntlets, disposable suits).

7 Eye protection: Safety glasses. Goggles, face shield, or other full-face protection if potential exists for direct exposure to aerosols or splashes. 9. PHYSICAL AND CHEMICAL PROPERTIES Product id: 1087957_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Product name: Nitroglycerin in 5% Dextrose Injection Physical state:LiquidAppearance:Aqueous solutionColor:ClearOdor:Not - weight:Not point/range:Not point/range:Not :Not pressure:Not rate:Not :Not coefficient (n-octanol/water):Not :Not Volatile by Volume:Not available. 10. STABILITY AND REACTIVITY Stability:Stable under recommended storage conditions. Polymerization:Not applicable Hazardous decomposition products:Not available.

8 Materials to avoid:Not available. 11. TOXICOLOGICAL INFORMATION ComponentLD50s and LC50s Nitroglycerin 55-63-0 Oral LD50 Rat = 105 mg/kgOral LD50 Mouse = 115 mg/kgDermal LD50 Rabbit >280 mg/kgIntravenous LD50 Rat = mg/kg Dextrose 5996-10-1 NoneEthyl Alcohol 64-17-5 Inhalation LC50 Rat = 20000 ppm/10 HInhalation LC50 Mouse = 39 gm/m3/4 HOral LD50 Rat = 7060 mg/kgOral LD50 Mouse = 3450 mg/kgCitric Acid Anhydrous 77-92-9 Oral LD50 Rat = 3 gm/kgOral LD50 Mouse = 5040 mg/kgWater 7732-18-5 Oral LD50 Rat: >50000 mg/kgProduct id: 1087957_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Product name: Nitroglycerin in 5% Dextrose Injection Acute toxicity:Nervous system effects (headache, dizziness, light headedness).

9 Cardiovascular effects (may include fluctuations in heart rate, changes in blood pressure, chest pain). Chronic toxicity:Target organs: heart. Carcinogenic effects:Not classified or listed by IARC, NTP, OSHA, EU and ACGIH. Potential increased incidence of neoplasm based on chronic animal administration. See patient package insert for additional information. Mutagenic effects:May be mutagenic. However, data too limited to be conclusive. See patient package insert for additional information. Reproductive toxicity:May impair fertility at high doses based on animal data. Not considered fetotoxic based on animal data. FDA Pregnancy Catagory C 12. ECOLOGICAL INFORMATION Environmental properties: ComponentEcotoxicity - Water Flea DataFish Species EcotoxicityEcotoxicity - Freshwater Algae DataMicrotox Etoxicity Data Nitroglycerin Alcohol (96 hr) rainbow trout (30 days old):12900-15300 mg/L:Flow-through, C, pH , mg/L CaCO3.

10 ;LC50 (24 hr) fingerling trout:11200 mg/L.:;LC50 (96 hr) fathead minnow:14200 mg/ min EC50 Photobacterium phosphoreum: 35470 mg/L; 30 min EC50 Photobacterium phosphoreum: 34634 mg/LCitric Acid Anhydrous min EC50 Photobacterium phosphoreum: 14 mg/LWater effects:No data available Bioaccumulation:No data available Product id: 1087957_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Product name: Nitroglycerin in 5% Dextrose Injection 13. DISPOSAL CONSIDERATIONS Waste Classification:Waste Classification must be determined by user. Waste from residues / unused products:Waste disposal must be in accordance with appropriate Federal, State, and local regulations. 14. TRANSPORT INFORMATION DOT: DOT shipping name:None UN Number:None DOT Packing Group:None DOT Hazard class:None TDG (Canada): TDG Proper shipping name:None TDG UN/NA Number:None TDG Packing Group:None TDG Hazard class:None ADR/RID: ADR Official Transport Name:None ADR Proper shipping name:None ADR UN/NA number:None ADR Hazard Class:None ICAO / IATA: IATA Proper shipping name:None IATA UN NUMBERNone IATA Primary HazardNone IATA Packing group:None ICAO ERG Code:None IMO / IMDG: IMDG Proper Shipping Name:None IMDG Hazard Class and Division:None IMDG Packing Group:None IMDG Subsidiary Risks:None 15.