Material Safety Data Sheet ANSI Format

Transcription

1 Material Safety Data Sheet ANSI Format Preparation Date 12-Feb-2007 Revision Date 01-Apr PRODUCT AND COMPANY IDENTIFICATION Revision Number 4 Product Name Common Name Chemical Name Synonyms Product Use Classification Supplier Centrum, Centrum Performance, Centrum Silver, Centrum Millennium, Centrum Ultra, Centrum Silver Millennium, Centrum Silver Ultra Dietary Supplement Vitamin Wyeth P.O. Box 8299 Philadelphia, PA USA. Telephone: Emergency Telephone Number Chemtrec USA, Puerto Rico, Canada Chemtrec International HAZARDS IDENTIFICATION Emergency Overview This product contains no substances which at their given concentration, are considered to be hazardous to health. Appearance Tablet Physical State Solid Odor Potential Physical Hazards Powders and solids are presumed to be combustible. Potential Health Effects Eyes Skin Inhalation Ingestion Therapeutic Target Organ(s) May cause mechanical eye irritation. Long-term intake of high levels of Vitamin A, other than from beta-carotene, may increase the risk of osteoporosis in postmenopausal women. None. Not listed by OSHA, NTP or IARC. Potential Environmental Effects There is no known ecological information for this product. 3. COMPOSITION/INFORMATION ON INGREDIENTS Common Name CAS-No Composition Inactive Ingredients Remainder Page 1

2 Common Name CAS-No Composition Magnesium (Magnesium Oxide) mg/tablet Pantothenic acid (Calcium Pantothenate) mg/tablet Boron mcg/tablet Calcium (Calcium Carbonate) mg/tablet Vitamin B1 (Thiamine Mononitrate) mg/tablet Biotin mcg/tablet Vitamin B6 (Pyridoxine Hydrochloride) mg/tablet Vitamin E (acetate) IU/tablet Folic Acid mcg/tablet Vitamin B12 (Cyanocobalamin) mcg/tablet Potassium mg/tablet Molybdenum (Sodium Molybdate) mcg/tablet Iodine (Potassium Iodide) mcg/tablet Phosphorus mg/tablet Vitamin B2 (Riboflavin) mg/tablet Vitamin K mcg/tablet Vitamin A IU/tablet Vitamin C (Ascorbic Acid) mg/tablet Ginkgo Biloba mg/tablet Silicon mg/tablet Tin mcg/tablet Lutein mcg/tablet Ginseng Root Not Applicable 0-50 mg/tablet Vitamin D IU/tablet Ferrous Fumarate mg/tablet Niacin mg/tablet Zinc Oxide mg/tablet Copper (Cupric Oxide) mg/tablet Manganese Sulfate mg/tablet Chromic Chloride mcg/tablet Chloride None Assigned 0-72 mg/tablet Selenium (Sodium Selenate) mcg/tablet Nickelous Sulfate mcg/tablet Vanadium (Sodium Metavanadate) mcg/tablet Dibasic Calcium Phosphate mg/tablet Potassium Chloride mg/tablet Magnesium Stearate mg/tablet Cupric Sulfate mg/tablet 4. FIRST AID MEASURES Eye Contact Skin Contact Inhalation Ingestion In case of contact with eyes, rinse immediately with plenty of water for 15 mintues and seek medical advice Wash off immediately with soap and plenty of water Artificial respiration and/or oxygen may be necessary Immediate medical attention is not required 5. FIRE-FIGHTING MEASURES Flammable Properties Presumed to be a combustible particulate solid. Extinguishing Media Page 2

3 Suitable Extinguishing Media Unsuitable Extinguishing Media Fire Fighting Hazardous Combustion Products Protective Equipment and Precautions for Firefighters Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide Do not use a solid water stream as it may scatter and spread fire Evacuate area and fight fire from a safe distance Hazardous Combustion Products As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear 6. ACCIDENTAL RELEASE MEASURES Personal Precautions Environmental Precautions Methods for Containment Methods for Cleaning up Safety glasses or goggles when splash potential exists Local authorities should be advised if a significant spill cannot be contained Take up mechanically and collect in suitable container for disposal 7. HANDLING AND STORAGE Handling Storage Handle in accordance with good industrial hygiene and safety practice Keep container tightly closed 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Engineering Controls Personal Protective Equipment Eye/face Protection Skin Protection Respiratory Protection General Hygiene Considerations Other No special precautions required. Avoid contact with skin and eyes. For prolonged or repeated exposure use protective gloves No personal respiratory protective equipment normally required. Limit access to only personnel trained in the safe handling of this material 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance Color Odor Threshold Tablet Various Physical State Odor Solid ph Page 3

4 Specific Gravity Solubility Partition Coefficient (n-octanol/water) Water Solubility Evaporation Rate Vapor Pressure Boiling Point Flash Point Melting Point Flammability Limits in Air Upper Upper Lower Autoignition Temperature Method Lower None 10. STABILITY AND REACTIVITY Chemical Stability Conditions to Avoid Materials to Avoid Hazardous Decomposition Products Possibility of Hazardous Reactions Stable at room temperature. No materials to be especially mentioned. None under normal use. None under normal use. 11. TOXICOLOGICAL INFORMATION Acute Toxicity Inactive Ingredients Magnesium (Magnesium Oxide) Pantothenic acid (Calcium Pantothenate) Boron Page 4

5 Calcium (Calcium Carbonate) Vitamin B1 (Thiamine Mononitrate) Biotin 6450 mg/kg rats Vitamin B6 (Pyridoxine Hydrochloride) Vitamin E (acetate) Folic Acid Vitamin B12 (Cyanocobalamin) Potassium Molybdenum (Sodium Molybdate) > 1900 mg/kg rats Page 5

6 Iodine (Potassium Iodide) Phosphorus Vitamin B2 (Riboflavin) Vitamin K Vitamin A Vitamin C (Ascorbic Acid) Ginkgo Biloba Silicon >11 gm/kg rats Tin Page 6

7 Lutein Ginseng Root Vitamin D2 Ferrous Fumarate Niacin Zinc Oxide Copper (Cupric Oxide) Manganese Sulfate Chromic Chloride 3850 mg/kg rats 1570 mg/kg mice 7000 mg/kg rats 3720 mg/kg mice 4550 mg/kg rabbits >5000 mg/kg rats Page 7

8 Chloride Selenium (Sodium Selenate) Nickelous Sulfate Vanadium (Sodium Metavanadate) Dibasic Calcium Phosphate Potassium Chloride Magnesium Stearate Cupric Sulfate Multiple Dose Toxicity Inactive Ingredients Page 8

9 Magnesium (Magnesium Oxide) Pantothenic acid (Calcium Pantothenate) Boron Calcium (Calcium Carbonate) Vitamin B1 (Thiamine Mononitrate) Biotin Vitamin B6 (Pyridoxine Hydrochloride) Vitamin E (acetate) Folic Acid Vitamin B12 (Cyanocobalamin) Potassium Molybdenum (Sodium Molybdate) Iodine (Potassium Iodide) Phosphorus Page 9

10 Vitamin B2 (Riboflavin) Vitamin K Vitamin A Vitamin C (Ascorbic Acid) Ginkgo Biloba Silicon Tin Lutein Ginseng Root Vitamin D2 Ferrous Fumarate Niacin Zinc Oxide Copper (Cupric Oxide) Page 10

11 Manganese Sulfate Chromic Chloride Chloride Selenium (Sodium Selenate) Nickelous Sulfate Vanadium (Sodium Metavanadate) Dibasic Calcium Phosphate Potassium Chloride Magnesium Stearate Cupric Sulfate Maximum Tolerated Dose (MTD), Oral Inactive Ingredients Magnesium (Magnesium Oxide) Not mutagenic in AMES Test. Page 11

12 Pantothenic acid (Calcium Pantothenate) Boron Calcium (Calcium Carbonate) Vitamin B1 (Thiamine Mononitrate) Biotin Vitamin B6 (Pyridoxine Hydrochloride) Vitamin E (acetate) Folic Acid Vitamin B12 (Cyanocobalamin) Page 12

13 Potassium Molybdenum (Sodium Molybdate) Iodine (Potassium Iodide) Phosphorus Vitamin B2 (Riboflavin) Vitamin K Vitamin A Vitamin C (Ascorbic Acid) Ginkgo Biloba Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of activity in male or female rats or mice. No studies to assess the mutagenic potential have been performed. Studies to evaluate the teratogenic potential have not been performed. Page 13

14 Silicon Tin Lutein Ginseng Root Vitamin D2 Ferrous Fumarate Niacin Zinc Oxide Copper (Cupric Oxide) Page 14

15 Manganese Sulfate Chromic Chloride Chloride Selenium (Sodium Selenate) Nickelous Sulfate Vanadium (Sodium Metavanadate) Dibasic Calcium Phosphate Potassium Chloride Magnesium Stearate Page 15

16 Cupric Sulfate Inactive Ingredients Magnesium (Magnesium Oxide) Pantothenic acid (Calcium Pantothenate) Boron Calcium (Calcium Carbonate) Vitamin B1 (Thiamine Mononitrate) Biotin Vitamin B6 (Pyridoxine Hydrochloride) Vitamin E (acetate) Folic Acid Vitamin B12 (Cyanocobalamin) Potassium Molybdenum (Sodium Molybdate) Iodine (Potassium Iodide) Phosphorus Vitamin B2 (Riboflavin) Page 16

17 Vitamin K Vitamin A Vitamin C (Ascorbic Acid) Ginkgo Biloba Silicon Tin Lutein Ginseng Root Vitamin D2 Ferrous Fumarate Niacin Zinc Oxide Copper (Cupric Oxide) Manganese Sulfate Chromic Chloride Chloride Selenium (Sodium Selenate) Nickelous Sulfate Page 17

18 Vanadium (Sodium Metavanadate) Dibasic Calcium Phosphate Potassium Chloride Magnesium Stearate Cupric Sulfate 12. ECOLOGICAL INFORMATION Chemical Fate Information Ecotoxicity 13. DISPOSAL CONSIDERATIONS Waste Disposal Method Dispose of unused product as hazardous waste 14. TRANSPORT INFORMATION Transport Information This material is not classified as hazardous for transport. U.S. Department of Transport (DOT) Canadian Transport of Dangerous Goods (TDG) International Civil Aviation Organization (ICAO) International Air Transport Association (IATA) International Maritime Dangerous Goods (IMDG)/International Maritime Organization (IMO) Transport of Dangerous Goods by Rail (RID) Transport of Dangerous Goods by Road (ADR) Transportation of Dangerous Goods via Inland Waterways (ADN) Not regulated Not regulated Not regulated Not regulated Not regulated Not regulated Not regulated Not regulated 15. REGULATORY INFORMATION USA Federal Regulations Page 18

19 OSHA Regulatory Status This material is not considered hazardous by the OSHA Hazard Communication Standard (29 CFR ) SARA 313 Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product contains a chemical or chemicals which are subject to the reporting requirements of the Act and Title 40 of the Code of Federal Regulations, Part 372: Common Name CAS-No Concentration Chromic Chloride <1% Zinc Oxide <1% Copper (Cupric Oxide) <1% Manganese Sulfate <1% Vanadium (Sodium Metavanadate) <1% Selenium (Sodium Selenate) <1% Nickelous Sulfate <1% SARA 311/312 Hazardous Categorization Acute Health Hazard Chronic Health Hazard Fire Hazard Sudden Release of Pressure Hazard Reactive Hazard No No No No No This product contains the following HAPs: Compounds of Selenium, Chromium, Nickel and Manganese. State Regulations California Proposition 65 This product contains the following Proposition 65 chemicals: Retinol/Retinyl esters, when in daily doses in excess of 10,000 IU or 3,000 retional equivalents. Listed on Proposition 65 as Developmental. Canada Not Determined WHMIS Hazard Class Not determined European Union Not Determined Page 19

20 16. OTHER INFORMATION Prepared By Wyeth Department of Environment, Health & Safety Format This MSDS was prepared in accordance with ANSI Z List of References See Patient Package Insert for more information. Revision Summary Addition to synonyms (Section 1). Disclaimer: The information, data, recommendations, and suggestions appearing in this material safety data sheet (MSDS) and/or in materials regarding our active pharmaceutical ingredients (APIs) or products are based upon tests and data believed to be reliable as of the date of publication. NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER WARRANTY IS MADE WITH REGARD TO THE INFORMATION PROVIDED IN THE MSDS, REGARDING THE API, OR THE PRODUCT TO WHICH THE INFORMATION PERTAINS. Accordingly, Wyeth will not be responsible for any damages resulting from use of, or reliance upon, this information as conditions of use are beyond our control. Users are responsible for assuring the safety of their workers and safe operating conditions, and for determining whether the API or product is suitable for their particular purposes. Users shall assume all risks of their use, handling, and disposal of the API and/or product in accordance with all appropriate and applicable regulations. This information relates only to the API or product designated herein, and does not relate to its use in combination with any other API, material, product, or process. No permission is granted for the use of any API or product in a manner that might infringe on existing patents. End of MSDS Page 20