MATERIAL SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Greenstone LLC Emergency telephone number: 100 Route 206 North CHEMTREC (24 hours): 1-800-424-9300 Peapack, NJ 07977 800-435-7095 Material Name: Metformin Hydrochloride Tablets (Greenstone LLC) Trade Name: Synonyms: Chemical Family: Intended Use:
Pharmaceutical product used as, antidiabetic agent
2. HAZARDS IDENTIFICATION Appearance: Signal Word: Statement of Hazard: Additional Hazard Information: Long Term:
Repeated or prolonged exposure may cause effects similar to those seen in clinical use. Known Clinical Effects:
Adverse effects most commonly reported in clinical use include diarrhea, nausea, vomiting,gastrointestinal disturbances, and headache. EU Indication of danger: EU Hazard Symbols: EU Risk Phrases: Australian Hazard Classification
Hazardous Substance. Non-Dangerous Goods. (NOHSC):
This document has been prepared in accordance with standards for workplace safety, whichrequire the inclusion of all known hazards of the active substance or its intermediatesregardless of the potential risk. The precautionary statements and warnings included may notapply in all cases. Your needs may vary depending upon the potential for exposure in yourworkplace. 3. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous Ingredient CAS Number EU EINECS/ELINCS List EU Classification _______________________________________________________________________________________________________ MATERIAL SAFETY DATA SHEET Material Name: Metformin Hydrochloride Tablets (Greenstone Page 2 of 6 LLC) Revision date: 08-Nov-2012 Version: 1.3 _______________________________________________________________________________________________________ 3. COMPOSITION/INFORMATION ON INGREDIENTS Magnesium stearate Ingredient CAS Number EU EINECS/ELINCS List EU Classification Additional Information:
* Proprietary*** per tablet/capsule/lozenge/suppositoryIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety. For the full text of the R phrases mentioned in this Section, see Section 16 4. FIRST AID MEASURES Eye Contact:
Flush with water while holding eyelids open for at least 15 minutes. Seek medical attentionimmediately. Skin Contact:
Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical attention. Ingestion:
Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention immediately. Inhalation:
Remove to fresh air and keep patient at rest. Seek medical attention immediately. Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - Hazards
Identification and/or Section 11 - Toxicological Information. 5. FIRE FIGHTING MEASURES Extinguishing Media:
Use carbon dioxide, dry chemical, or water spray. Hazardous Combustion Products:
Formation of toxic gases is possible during heating or fire. Fire Fighting Procedures:
During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus. Fire / Explosion Hazards:
Fine particles (such as dust and mists) may fuel fires/explosions. 6. ACCIDENTAL RELEASE MEASURES Health and Safety Precautions:
Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8). Minimize exposure. Measures for Cleaning / Collecting:
Contain the source of spill if it is safe to do so. Collect spilled material by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area thoroughly. Measures for Environmental
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to
Protections: _______________________________________________________________________________________________________ MATERIAL SAFETY DATA SHEET Material Name: Metformin Hydrochloride Tablets (Greenstone Page 3 of 6 LLC) Revision date: 08-Nov-2012 Version: 1.3 _______________________________________________________________________________________________________ Additional Consideration for Large
Non-essential personnel should be evacuated from affected area. Report emergency
situations immediately. Clean up operations should only be undertaken by trained personnel. 7. HANDLING AND STORAGE General Handling:
Minimize dust generation and accumulation. If tablets or capsules are crushed and/or broken,avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, useappropriate personal protective equipment (see Section 8). Wash hands and any exposed skinafter removal of PPE. Review and implement appropriate technical and procedural waste waterand waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphere should be controlledwith dust collectors, HEPA filtration systems or other equivalent controls. Storage Conditions:
Store as directed by product packaging. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Refer to available public information for specific member state Occupational Exposure Limits. Magnesium stearate ACGIH Threshold Limit Value (TWA) Lithuania OEL - TWA Sweden OEL - TWAs Manufacturer OEB Statement:
The purpose of the Occupational Exposure Band (OEB) classification system is to separatesubstances into different Hazard categories when the available data are sufficient to do so, butinadequate to establish an Occupational Exposure Limit (OEL). The OEB given is based uponan analysis of all currently available data; as such, this value may be subject to revision whennew information becomes available. Metformin Hydrochloride Manufacturer OEB:
OEB1 (control exposure to the range of >1000ug/m3 to < 3000ug/m3)
Engineering Controls:
Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this section. Personal Protective Equipment:
Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).
Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing operations.
Wear safety glasses or goggles if eye contact is possible.
Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing operations. Respiratory protection:
If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the OEL. 9. PHYSICAL AND CHEMICAL PROPERTIES Physical State: Molecular Formula: Molecular Weight: _______________________________________________________________________________________________________ MATERIAL SAFETY DATA SHEET Material Name: Metformin Hydrochloride Tablets (Greenstone Page 4 of 6 LLC) Revision date: 08-Nov-2012 Version: 1.3 _______________________________________________________________________________________________________ 9. PHYSICAL AND CHEMICAL PROPERTIES 10. STABILITY AND REACTIVITY Chemical Stability:
Stable under normal conditions of use. Conditions to Avoid:
Fine particles (such as dust and mists) may fuel fires/explosions. Incompatible Materials:
As a precautionary measure, keep away from strong oxidizers
11. TOXICOLOGICAL INFORMATION General Information:
The information included in this section describes the potential hazards of the individualingredients. Acute Toxicity: (Species, Route, End Point, Dose) Metformin Hydrochloride Rat Oral LD50 1000 mg/kg Mouse Oral LD50 1450 mg/kg Rat Subcutaneous LD50 300 mg/kg Povidone Rat Oral LD50 100 g/kg Magnesium stearate Rat Oral LD50 > 2000 mg/kg Rat Inhalation LC50 > 2000 mg/m3 Irritation / Sensitization: (Study Type, Species, Severity) Metformin Hydrochloride Eye Irritation Rabbit Mild Skin Irritation Rabbit Mild Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) Metformin Hydrochloride 78 Week(s) Rat Oral 300 mg/kg/day LOAEL Female reproductive system Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Metformin Hydrochloride Fertility and Embryonic Development Rat No route specified 600 mg/kg/day NOAEL Not teratogenic Fertility and Embryonic Development Rabbit No route specified 600 mg/kg/day NOAEL Not Teratogenic Genetic Toxicity: (Study Type, Cell Type/Organism, Result) Metformin Hydrochloride In Vitro Bacterial Mutagenicity (Ames) Not specified Negative In Vitro Chromosome Aberration Not specified Negative In Vivo Mammalian Cell Mutagenicity Micronucleus Mouse Negative _______________________________________________________________________________________________________ MATERIAL SAFETY DATA SHEET Material Name: Metformin Hydrochloride Tablets (Greenstone Page 5 of 6 LLC) Revision date: 08-Nov-2012 Version: 1.3 _______________________________________________________________________________________________________ 11. TOXICOLOGICAL INFORMATION Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Metformin Hydrochloride 91 Week(s) Mouse No route specified 1500 mg/kg/day NOAEL Not carcinogenic 104 Week(s) Rat No route specified Not carcinogenic Carcinogen Status:
None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. Povidone 12. ECOLOGICAL INFORMATION Environmental Overview:
Environmental properties have not been thoroughly investigated. Releases to the environmentshould be avoided. Aquatic Toxicity: (Species, Method, End Point, Duration, Result) Metformin Hydrochloride Lepomis macrochirus (Bluegill Sunfish) LC50 96 Hours > 982 mg/L Daphnia magna (Water Flea) EC50 48 Hours 130 mg/L 13. DISPOSAL CONSIDERATIONS Waste Treatment Methods:
Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the material, review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and wastewater. 14. TRANSPORT INFORMATION The following refers to all modes of transportation unless specified below.
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. 15. REGULATORY INFORMATION EU Indication of danger: EU Risk Phrases: EU Safety Phrases: _______________________________________________________________________________________________________ MATERIAL SAFETY DATA SHEET Material Name: Metformin Hydrochloride Tablets (Greenstone Page 6 of 6 LLC) Revision date: 08-Nov-2012 Version: 1.3 _______________________________________________________________________________________________________ 15. REGULATORY INFORMATION OSHA Label: WARNING Harmful if swallowed. Canada - WHMIS: Classifications WHMIS hazard class: None required Metformin Hydrochloride Australia (AICS): EU EINECS/ELINCS List Magnesium stearate Inventory - United States TSCA - Sect. 8(b) Australia (AICS): EU EINECS/ELINCS List Povidone Inventory - United States TSCA - Sect. 8(b) Australia (AICS): 16. OTHER INFORMATION Text of R phrases mentioned in Section 3
R22 - Harmful if swallowed. Data Sources:
The data contained in this MSDS may have been gathered from confidential internal sources,raw material suppliers, or from the published literature. Reasons for Revision:
Updated Section 2 - Hazard Identification. Updated Section 9 - Physical and ChemicalProperties. Updated Section 1 - Identification of the Substance/Preparation and theCompany/Undertaking. Prepared by:
Global Environment, Health, and Safety Operations
It is believed that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it iswithout a warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no knowninformation at this time
End of Safety Data Sheet _______________________________________________________________________________________________________
Fogli di gel al silicone per la prevenzione e il trattamento delle cicatrici ipertrofiche e cheloidali. Articolo originale: Silicon gel sheeting for preventing and treating hypertrophic and keloid scars Lisa O'Brien1, Abhay Pandit2 1Occupational Therapy, Monash University, Frankston, Australia. 2National University of Ireland, Galway, Ireland Contact address: Lisa O'Brien, Occupational Ther
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MATERIAL SAFETY DATA SHEET