: Ciprofloxacin Tablets USP 100, 500, 750mg

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1 Date of issue: 04/29/2014 Version: 1.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form Product name. : Mixture : Ciprofloxacin Tablets USP 100, 500, 750mg 1.2. 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 Dr. Reddy's Laboratories Ltd Road No. 3, Banjara Hills Hyderabad , - India T F Emergency telephone number Emergency number : CHEMTREC (24 hrs., 7 days per week): United States: (800) CCN SECTION 2: Hazards identification 2.1. Classification of the substance or mixture GHS-US classification Not classified 2.2. Label elements GHS-US labelling No labelling applicable 2.3. Other hazards 2.4. Unknown acute toxicity (GHS-US) No data available SECTION 3: Composition/information on ingredients 3.1. Substances Not applicable 3.2. Mixture Only the main constituent and those with a health hazard present above the applicable thresholds are present. Specific composition withheld as trade secret. Full text of H-phrases: see section 16 Name Product identifier % GHS-US classification ciprofloxacin hydrochloride (Main constituent) (CAS No) Not classified sodium starch glycolate (CAS No) Eye Irrit. 2A, H319 STOT SE 3, H335 SECTION 4: First aid measures 4.1. Description of first aid measures First-aid measures general First-aid measures after inhalation First-aid measures after skin contact First-aid measures after eye contact First-aid measures after ingestion : Never give anything by mouth to an unconscious person. IF exposed or concerned: Get medical advice/attention. : If inhaled and if breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. : Wash with plenty of soap and water. : If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. : Do NOT induce vomiting unless directed to do so by medical personnel. Call a POISON CENTER/doctor/physician if you feel unwell Most important symptoms and effects, both acute and delayed Symptoms/injuries : Not expected to present a significant hazard under anticipated conditions of normal use. 04/29/2014 EN (English) SDS ID: DrR_ Page 1

2 4.3. Indication of any immediate medical attention and special treatment needed All treatments should be based on observed signs and symptoms of distress in the patient. SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media : Carbon dioxide. Dry powder. Sand. Water fog. Foam. : Do not use a heavy water stream Special hazards arising from the substance or mixture Fire hazard Explosion hazard Reactivity : No specific fire or explosion hazard. : Product is not explosive. : Normally stable, even under fire exposure conditions, and not reactive with water. No dangerous reactions known Advice for firefighters Firefighting instructions Protection during firefighting : Exercise caution when fighting any chemical fire. Use extinguishing media appropriate for surrounding fire. : Do not enter fire area without proper protective equipment, including respiratory protection. Wear fire/flame resistant/retardant clothing. Wear a self contained breathing apparatus. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures General measures : Avoid contact with skin and eyes. Avoid creating or spreading dust For non-emergency personnel Protective equipment Emergency procedures For emergency responders Protective equipment Emergency procedures : Wear suitable gloves. Dust impervious gloves. : Evacuate unnecessary personnel. : Wear suitable gloves. Dust impervious gloves. : Ventilate area Environmental precautions Contains no substances known to be hazardous to the environment Methods and material for containment and cleaning up For containment Methods for cleaning up 6.4. Reference to other sections : Absorb and/or contain spill with inert material, then place in suitable container. Avoid generating dust. : On land, sweep or shovel into suitable containers. Minimize generation of dust. Section 13: disposal information. Section 7: safe handling. Section 8: personal protective equipment. SECTION 7: Handling and storage 7.1. Precautions for safe handling Precautions for safe handling Hygiene measures : Does not necessitate any specific/particular technical measures, other than those concerning the handling of powders. Provide good ventilation in process area to prevent formation of dust. : Wash hands and other exposed areas with mild soap and water before eating, drinking or smoking and when leaving work Conditions for safe storage, including any incompatibilities Storage conditions Incompatible materials 7.3. Specific end use(s) Pharmaceuticals. : Keep only in the original container in a cool well ventilated place. Keep container closed when not in use. : Strong acids. Oxidizer. Bases. SECTION 8: Exposure controls/personal protection 8.1. Control parameters sodium starch glycolate ( ) USA OSHA OSHA PEL (TWA) (mg/m3) 15 mg/m³ total dust USA OSHA OSHA PEL (STEL) (mg/m3) 5 mg/m³ respirable fraction 04/29/2014 EN (English) SDS ID: DrR_ /6

3 ciprofloxacin hydrochloride ( ) OEL = 1000 μg/m3 (8-hr TWA) 8.2. Exposure controls Appropriate engineering controls Hand protection Eye protection Respiratory protection : Avoid dispersal of dust in the air (ie, clearing dust surfaces with compressed air). Either local exhaust or general room ventilation is usually required. : It is a good industrial hygiene practice to minimize skin contact. Wear dust impervious gloves. : In case of dust production: protective goggles. : In case of insufficient ventilation, wear suitable respiratory equipment. Use air-purifying respirator equipped with particulate filtering cartridges. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Solid Appearance : Tablets. Colour : White. Odour : Odourless. Odour threshold ph Relative evaporation rate (butylacetate=1) Melting point Freezing point Boiling point Flash point Self ignition temperature Decomposition temperature Flammability (solid, gas) Vapour pressure Relative vapour density at 20 C Relative density Solubility Log Pow Log Kow Viscosity, kinematic Viscosity, dynamic Explosive properties : Product is not explosive. Oxidising properties : No oxidizing properties. Explosive limits 9.2. Other information SECTION 10: Stability and reactivity Reactivity Normally stable, even under fire exposure conditions, and not reactive with water. No dangerous reactions known Chemical stability Stable under normal conditions Possibility of hazardous reactions Hazardous polymerization will not occur Conditions to avoid Extremely high or low temperatures Incompatible materials Strong acids. Strong bases. Strong oxidizers. 04/29/2014 EN (English) SDS ID: DrR_ /6

4 10.6. Hazardous decomposition products No dangerous decomposition products known. SECTION 11: Toxicological information Information on toxicological effects Acute toxicity ciprofloxacin hydrochloride ( ) LD50 oral rat LD50 oral mouse Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity (single exposure) Specific target organ toxicity (repeated exposure) Aspiration hazard > 2000 mg/kg 5000 mg/kg Ciprofloxacin hydrochloride - Negative in microbial mutagenicity assays, V79 mammalian cell mutation assay, the mouse micronucleus assay and the dominant lethal assay. Positive in a mouse lymphoma assay and an in vitro rat hepatocyte DNA repair test. Ciprofloxacin hydrochloride - Long term tests in rats and mice at daily oral doses up to 250 and 750 mg/kg, respectively, resulted in no carcinogenic or tumorigenic effects Ciprofloxacin hydrochloride - Oral reproductive and developmental toxicity studies in mice, rats, monkeys and rabbits revealed no evidence of harm. No effects on fertility were seen with oral doses up to 100 mg/kg/day. SECTION 12: Ecological information Toxicity Persistence and degradability Bioaccumulative potential Mobility in soil Other adverse effects SECTION 13: Disposal considerations Waste treatment methods Waste disposal recommendations : Dispose in a safe manner in accordance with local/national regulations. SECTION 14: Transport information In accordance with DOT Not considered a dangerous good for transport regulations Additional information Other information : No supplementary information available. ADR Transport document description : Not applicable Transport by sea 04/29/2014 EN (English) SDS ID: DrR_ /6

5 Air transport SECTION 15: Regulatory information US Federal regulations International regulations CANADA Ciprofloxacin Tablets USP 100, 500, 750mg WHMIS Classification Uncontrolled product according to WHMIS classification criteria EU-Regulations Classification according to Regulation (EC) No. 1272/2008 [CLP] Not classified Classification according to Directive 67/548/EEC or 1999/45/EC Xn; R National regulations US State regulations Not listed on any state Right-to-Know Hazardous Chemicals lists. SECTION 16: Other information Indication of changes : Original Document. Data sources : ACGIH Abbreviations and acronyms European Chemicals Agency (ECHA) Registered Substances list. Accessed at Krister Forsberg and S.Z. Mansdorf, "Quick Selection Guide to Chemical Protective Clothing", Fifth Edition. National Fire Protection Association; Fire Protection Guide to Hazardous Materials; 10th edition. OSHA 29CFR Hazard Communication Standard. TSCA Chemical Substance Inventory. Accessed at : ACGIH (American Conference of Governement Industrial Hygienists). ATE: Acute Toxicity Estimate. CAS (Chemical Abstracts Service) number. CLP: Classification, Labelling, Packaging. EC50: Environmental Concentration associated with a response by 50% of the test population. GHS: Globally Harmonized System (of Classification and Labeling of Chemicals). LD50: Lethal Dose for 50% of the test population. OSHA: Occupational Safety & Health Administration. STEL: Short Term Exposure Limits. TSCA: Toxic Substances Control Act. TWA: Time Weight Average. Full text of H-phrases: see section 16: Eye Irrit. 2A Serious eye damage/eye irritation Category 2A STOT SE 3 Specific target organ toxicity (single exposure) Category H319 Causes serious eye irritation H335 May cause respiratory irritation 04/29/2014 EN (English) SDS ID: DrR_ /6

6 NFPA health hazard NFPA fire hazard NFPA reactivity : 0 - Exposure under fire conditions would offer no hazard beyond that of ordinary combustible materials. : 1 - Must be preheated before ignition can occur. : 0 - Normally stable, even under fire exposure conditions, and not reactive with water. SDS US (GHS HazCom 2012) SDS prepared by: The Redstone Group, LLC Emerald Pkwy Suite 200 Dublin, Ohio, USA Dr. Reddy s Laboratories provides the information contained herein in good faith but makes no representation as to its comprehensiveness or accuracy. This document is intended only as a brief summary and general guide to the appropriate precautionary handling of this material by a properly trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for any particular purpose. DR. REDDY S LABORATORIES MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT TO WHICH THE INFORMATION REFERS. ACCORDINGLY, DR. REDDY S LABORATORIES WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS INFORMATION. 04/29/2014 EN (English) SDS ID: DrR_ /6