SIGMA-ALDRICH MATERIAL SAFETY DATA SHEET Date Printed: 03/18/2008 Date Updated: 02/04/2006 Version 1.1 Section 1 - Product and Company Information Product Name AMIODARONE HYDROCHLORIDE Product Number A8423 Brand SIGMA Company Sigma-Aldrich Canada, Ltd Address 2149 Winston Park Drive Oakville ON L6H 6J8 CA Technical Phone: 9058299500 Fax: 9058299292 Emergency Phone: 800-424-9300 Section 2 - Composition/Information on Ingredient Substance Name CAS # SARA 313 AMIODARONE HYDROCHLORIDE 19774-82-4 No Formula C25H29I2NO3 · HCl Synonyms Amiodarone hydrochloride * Amiodaronum hydrochloride * 2-Butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone hydrochloride * Cordarone * L 3428 * L 3428 labaz * Methanone, (2-butyl-3-benzofuranyl)(4-(2-(diethylamino)ethoxy )-3,5-diiodophenyl)-, HCl * SKF 33134 A * Trangorex RTECS Number: OB1361000 Section 3 - Hazards Identification EMERGENCY OVERVIEW Harmful.
Harmful by inhalation, in contact with skin and if swallowed.
Photosensitizer. Target organ(s): Lungs. Liver. Calif. Prop. 65 developmental hazard.
HMIS RATING HEALTH: 5 FLAMMABILITY: 0 REACTIVITY: 0 NFPA RATING HEALTH: 1 FLAMMABILITY: 0 REACTIVITY: 0 *additional chronic hazards present.
For additional information on toxicity, please refer to Section 11.
Section 4 - First Aid Measures
ORAL EXPOSURE If swallowed, wash out mouth with water provided person is conscious. Call a physician.
INHALATION EXPOSURE If inhaled, remove to fresh air. If breathing becomes difficult, call a physician.
DERMAL EXPOSURE In case of skin contact, flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing and shoes.
Call a physician.
EYE EXPOSURE In case of contact with eyes, flush with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating the eyelids with fingers. Call a physician.
Section 5 - Fire Fighting Measures FLASH POINT N/A AUTOIGNITION TEMP N/A FLAMMABILITY N/A EXTINGUISHING MEDIA Suitable: Water spray. Carbon dioxide, dry chemical powder, or appropriate foam.
FIREFIGHTING Protective Equipment: Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
Section 6 - Accidental Release Measures PROCEDURE(S) OF PERSONAL PRECAUTION(S) Wear respirator, chemical safety goggles, rubber boots, and heavy rubber gloves.
METHODS FOR CLEANING UP Sweep up, place in a bag and hold for waste disposal. Ventilate area and wash spill site after material pickup is complete.
Section 7 - Handling and Storage HANDLING User Exposure: Do not breathe dust. Avoid contact with eyes, skin, and clothing.
STORAGE Suitable: Keep tightly closed. Store in a cool dry place.
Store at 2-8˚C Section 8 - Exposure Controls / PPE ENGINEERING CONTROLS Mechanical exhaust required.
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PERSONAL PROTECTIVE EQUIPMENT Other: Wear appropriate government approved respirator, chemical-resistant gloves, safety goggles, other protective clothing.
Section 9 - Physical/Chemical Properties Appearance Physical State: Solid Property Value At Temperature or Pressure Molecular Weight 681.8 AMU pH N/A BP/BP Range N/A MP/MP Range N/A Freezing Point N/A Vapor Pressure N/A Vapor Density N/A Saturated Vapor Conc. N/A SG/Density N/A Bulk Density N/A Odor Threshold N/A Volatile% N/A VOC Content N/A Water Content N/A Solvent Content N/A Evaporation Rate N/A Viscosity N/A Surface Tension N/A Partition Coefficient N/A Decomposition Temp. N/A Flash Point N/A Explosion Limits N/A Flammability N/A Autoignition Temp N/A Refractive Index N/A Optical Rotation N/A Miscellaneous Data N/A Solubility N/A N/A = not available Section 10 - Stability and Reactivity STABILITY Stable: Stable.
Materials to Avoid: Strong oxidizing agents.
HAZARDOUS DECOMPOSITION PRODUCTS Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, and nitrogen oxides.
HAZARDOUS POLYMERIZATION Hazardous Polymerization: Will not occur Section 11 - Toxicological Information ROUTE OF EXPOSURE Multiple Routes: May cause irritation. Harmful if swallowed, inhaled, or absorbed through skin.
SENSITIZATION SIGMA - A8423 www.sigma-aldrich.com Page 3
TARGET ORGAN(S) OR SYSTEM(S) Damage to the liver. Damage to the lungs.
SIGNS AND SYMPTOMS OF EXPOSURE Prolonged exposure can cause: Damage to the lungs. Damage to the liver. Significant heart block or sinus bradycardia.
TOXICITY DATA Oral Oral Man Man 3129 mg/kg 3129 mg/kg LDLO LDLO Remarks: Lungs, Thorax, or Respiration:Other changes. Lungs, Thorax, or Respiration:Pleural thickening. Lungs, Thorax, or Respiration:Pleural thickening. Lungs, Thorax, or Respiration:Other changes.
Oral Oral Rat Rat > 3000 mg/kg > 3000 mg/kg LD50 LD50 Intraperitoneal Intraperitoneal Rat Rat 610 MG/KG 610 MG/KG LD50 LD50 Intravenous Intravenous Rat Rat 170 MG/KG 170 MG/KG LD50 LD50 Oral Oral Mouse Mouse > 3000 mg/kg > 3000 mg/kg LD50 LD50 Intraperitoneal Intraperitoneal Mouse Mouse 450 MG/KG 450 MG/KG LD50 LD50 Oral Oral Dog Dog > 5000 mg/kg > 5000 mg/kg LD50 LD50 Intravenous Intravenous Dog Dog 5 GM/KG 5 GM/KG LD50 LD50 CHRONIC EXPOSURE - REPRODUCTIVE HAZARD Species: Rat Rat Dose: 245 MG/KG 245 MG/KG Route of Application: Oral Oral Exposure Time: (16-22D PREG) (16-22D PREG) Result: Effects on Newborn: Physical. Effects on Newborn: SIGMA - A8423 www.sigma-aldrich.com Page 4
Species: Rat Rat Dose: 900 MG/KG 900 MG/KG Route of Application: Oral Oral Exposure Time: (6-15D PREG) (6-15D PREG) Result: Effects on Fertility: Other measures of fertility Effects on Fertility: Pre-implantation mortality (e.g., reduction in number of implants per female; total number of implants per corpora lutea). Effects on Newborn: Growth statistics (e.g., reduced weight gain). Effects on Newborn: Growth statistics (e.g., reduced weight gain). Effects on Fertility: Other measures of fertility Effects on Fertility: Pre-implantation mortality (e.g., reduction in number of implants per female; total number of implants per corpora lutea).
Species: Rat Rat Dose: 300 MG/KG 300 MG/KG Route of Application: Oral Oral Exposure Time: (6-15D PREG) (6-15D PREG) Result: Effects on Fertility: Litter size (e.g.; # fetuses per litter; measured before birth). Effects on Fertility: Litter size (e.g.; # fetuses per litter; measured before birth).
Species: Rat Rat Dose: 1 GM/KG 1 GM/KG Route of Application: Oral Oral Exposure Time: (6-15D PREG) (6-15D PREG) Result: Effects on Newborn: Physical. Effects on Newborn: Physical.
Section 12 - Ecological Information No data available.
Section 13 - Disposal Considerations APPROPRIATE METHOD OF DISPOSAL OF SUBSTANCE OR PREPARATION Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state, and local environmental regulations.
Section 14 - Transport Information DOT Proper Shipping Name: None Non-Hazardous for Transport: This substance is considered to be non-hazardous for transport.
IATA Non-Hazardous for Air Transport: Non-hazardous for air transport.
Section 15 - Regulatory Information EU ADDITIONAL CLASSIFICATION Symbol of Danger: Xn Indication of Danger: Harmful.
R: 20/21/22 Risk Statements: Harmful by inhalation, in contact with skin and if swallowed.
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S: 36 Safety Statements: Wear suitable protective clothing.
US CLASSIFICATION AND LABEL TEXT Indication of Danger: Harmful.
Risk Statements: Harmful by inhalation, in contact with skin and if swallowed.
Safety Statements: Wear suitable protective clothing.
US Statements: Photosensitizer. Target organ(s): Lungs. Liver.
Calif. Prop. 65 developmental hazard.
UNITED STATES REGULATORY INFORMATION SARA LISTED: No UNITED STATES - STATE REGULATORY INFORMATION CALIFORNIA PROP - 65 California Prop - 65: This product is or contains chemical(s) known to the state of California to cause developmental toxicity.
CANADA REGULATORY INFORMATION WHMIS Classification: This product has been classified in accordance with the hazard criteria of the CPR, and the MSDS contains all the information required by the CPR.
DSL: No NDSL: No Section 16 - Other Information DISCLAIMER For R&D use only. Not for drug, household or other uses.
WARRANTY The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Sigma-Aldrich Inc., shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale.
Copyright 2008 Sigma-Aldrich Co. License granted to make unlimited paper copies for internal use only.
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November 25, 2008 Dear Provider: The following changes will go into effect December 1, 2008, regarding our Formulary coverage. Please take a moment to familiarize yourself and staff to the amendments. Additions: none Deletions: Beta-blockers —Blocarden (timolol) Alpha-blockers —Wytensin (guanabenz) Ophthalmics —Iopidine (apraclonidine), Isopto-Carbachol (carbachol), Pho
Data Sheet Teicoplanin 400 mg lyophilised powder for injection with water for injections ampoule. PRESENTATION Teicoplanin lyophilised powder for injections is an off-white, odourless powder contained in a vial of 20 mL (400 mg) together with ampoules of water for injections. Teicoplanin is a complex mixture of 6 major components with molecular weights ranging from 1564 - 1894.