: Ibandronate Sodium Injection 3 mg/3 ml

Transcription

1 SECTION 1: Identification 1.1. Identification Product name : Ibandronate Sodium Injection 3 mg/3 ml Other means of identification : 1 mg/ml, 3 ml PFS NDC Relevant identified uses of the substance or mixture and uses advised against Use of the substance/mixture : Pharmaceutical 1.3. Details of the supplier of the safety data sheet AuroMedics 6 Wheelling Road Dayton, NJ T Emergency telephone number Emergency number : , option 2 SECTION 2: Hazard(s) identification 2.1. Classification of the substance or mixture Classification (GHS-US) Not classified 2.2. Label elements GHS-US labeling No labeling applicable 2.3. Other hazards 2.4. Unknown acute toxicity (GHS US) Not applicable SECTION 3: Composition/information on ingredients 3.1. Substance Not applicable 3.2. Mixture Name Product identifier % Classification (GHS-US) Water (CAS No) > 98 Not classified Ibandronate (as ibandronate sodium monohydrate) (CAS No) Not classified Acetic acid (CAS No) < 0.1 Flam. Liq. 3, H226 Acute Tox. 4 (Dermal), H312 Sodium chloride (CAS No) < 1 Not classified Sodium acetate trihydrate (CAS No) < 0.1 Not classified Full text of H-phrases: see section 16 SECTION 4: First aid measures 4.1. Description of first aid measures First-aid measures after inhalation First-aid measures after skin contact First-aid measures after eye contact First-aid measures after ingestion : If not breathing, give artificial respiration. : Drench affected area with water. : Rinse immediately with tap water for 10 minutes - open eyelids forcibly. : Seek immediate medical attention Most important symptoms and effects, both acute and delayed Symptoms/injuries after inhalation : May cause irritation to mucous membranes. Symptoms/injuries after skin contact : May cause skin irritation. Symptoms/injuries after eye contact : May causes eye irritation. Symptoms/injuries after ingestion : May be harmful if swallowed. 09/09/2015 EN (English US) Page 1

2 4.3. Indication of any immediate medical attention and special treatment needed SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media : Use extinguishing media appropriate for surrounding fire. : None Special hazards arising from the substance or mixture Fire hazard : None known Advice for firefighters Protection during firefighting : Firefighters should wear full protective gear. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures General measures For non-emergency personnel For emergency responders 6.2. Environmental precautions Prevent entry to sewers and public waters. : No special measures required Methods and material for containment and cleaning up For containment : Stop the flow of material, if this is without risk. Methods for cleaning up : Confine spill and soak up with absorbent. Place in an approved container and dispose in accordance with local, state and federal regulations Reference to other sections SECTION 7: Handling and storage 7.1. Precautions for safe handling Precautions for safe handling : Avoid contact with eyes, skin or clothing. Wash after handling Conditions for safe storage, including any incompatibilities Storage conditions : Store at 20 to 25 C (68 to 77 F). SECTION 8: Exposure controls/personal protection 8.1. Control parameters ACGIH ACGIH TWA (ppm) 10 ppm ACGIH ACGIH STEL (ppm) 15 ppm OSHA OSHA PEL (TWA) (mg/m³) 25 mg/m³ OSHA OSHA PEL (TWA) (ppm) 10 ppm 8.2. Exposure controls Appropriate engineering controls Hand protection Eye protection Skin and body protection Respiratory protection : Local exhaust and general ventilation must be adequate to meet exposure standards. : Use neoprene or rubber gloves. : Safety glasses. : Wear suitable working clothes. : None nececessary during normal operations. 09/09/2015 EN (English US) 2/5

3 SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Liquid Appearance : Clear. Color : Colorless Odor : Odorless Odor threshold ph : Melting point Freezing point Boiling point Flash point Relative evaporation rate (butyl acetate=1) Flammability (solid, gas) Explosion limits Explosive properties Oxidizing properties Vapor pressure Relative density Relative vapor density at 20 C Solubility : Completely soluble. Log Pow Auto-ignition temperature Decomposition temperature Viscosity Viscosity, kinematic Viscosity, dynamic 9.2. Other information SECTION 10: Stability and reactivity Reactivity Chemical stability The product is stable at normal handling and storage conditions Possibility of hazardous reactions Will not occur Conditions to avoid Temperatures above 25 C Incompatible materials None known Hazardous decomposition products None known. SECTION 11: Toxicological information Information on toxicological effects Acute toxicity LD50 dermal rabbit 3310 mg/kg 1060 mg/kg 09/09/2015 EN (English US) 3/5

4 LC50 inhalation rat (mg/l) ATE US (oral) ATE US (dermal) 11.4 mg/l/4h mg/kg mg/kg 3 g/kg LC50 inhalation rat (mg/l) > 42 g/m³ (Exposure time: 1 h) ATE US (oral) mg/kg Water ( ) Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity > 90 ml/kg ph: ph: Reproductive toxicity Specific target organ toxicity (single exposure) Specific target organ toxicity (repeated exposure) Aspiration hazard SECTION 12: Ecological information Toxicity LC50 fish 1 EC50 Daphnia 1 LC50 fish 2 LC50 fish 1 EC50 Daphnia 1 LC50 fish 2 EC50 Daphnia 2 79 mg/l (Exposure time: 96 h - Species: Pimephales promelas [static]) 65 mg/l (Exposure time: 48 h - Species: Daphnia magna [Static]) 75 mg/l (Exposure time: 96 h - Species: Lepomis macrochirus [static]) mg/l (Exposure time: 96 h - Species: Lepomis macrochirus [flow-through]) 1000 mg/l (Exposure time: 48 h - Species: Daphnia magna) mg/l (Exposure time: 96 h - Species: Lepomis macrochirus [static]) mg/l (Exposure time: 48 h - Species: Daphnia magna [Static]) Persistence and degradability Bioaccumulative potential Log Pow BCF fish (at 20 C) (no bioaccumulation) Mobility in soil Other adverse effects 09/09/2015 EN (English US) 4/5

5 Effect on the global warming : No known ecological damage caused by this product. SECTION 13: Disposal considerations Waste treatment methods Waste disposal recommendations SECTION 14: Transport information Department of Transportation (DOT) In accordance with DOT Not regulated for transport SECTION 15: Regulatory information US Federal regulations Water ( ) US State regulations : Dispose of contents/container in accordance with local/regional/national/international regulations. U.S. - Massachusetts - Right To Know List U.S. - Minnesota - Hazardous Substance List U.S. - New Jersey - Right to Know Hazardous Substance List U.S. - Pennsylvania - RTK (Right to Know) List SECTION 16: Other information Full text of H-phrases: Acute Tox. 4 (Dermal) Acute toxicity (dermal) Category Flam. Liq. 3 Flammable liquids Category H226 Flammable liquid and vapor H312 Harmful in contact with skin This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product 09/09/2015 EN (English US) 5/5