Gadobutrol Monohydrate — Safety Data Sheet — Cleanchem PAGE 1 MATERIAL SAFETY DATA SHEETS GADOBUTROL MONOHYDRATE 1.IDENTIFICATION 1.1 GHS PRODUCT IDENTIFIER Product Name Gadobutrol Monohydrate 1.2 OTHER MEANS OF IDENTIFICATION Product Name Gadobutrol Monohydrate Gadolinium 2,2?,2?-[10-[(1RS,2SR)-2,3-dihydroxy-1-(hydroxymethyl)propyl]-1,4,7,10- Other names tetraazacyclododecane-1,4,7-triyl]triacetate hydrate 1.3 RECOMMENDED USE OF THE CHEMICAL AND RESTRICTIONS ON USE Identified uses Industrial and scientific research uses Uses advised against No data available 1.4 SUPPLIER'S DETAILS Company Cleanchem Laboratories LLP Plot No.R-80, 2nd Floor, Prama Instruments,TTC Industrial area, Rabale, Navi Address Mumbai, Maharashtra- 400 701 Telephone 022-27601987 2. HAZARD IDENTIFICATION 2.1 CLASSIFICATION OF THE SUBSTANCE OR MIXTURE NO DATA AVAILABLE 2.2 GHS LABEL ELEMENTS, INCLUDING PRECAUTIONARY STATEMENTS Pictogram(s) No data available Signal word No data available Hazard statement(s) No data available Precautionary statement(s) Prevention No data available Response No data available Storage No data available Disposal No data available Hazard(s) not otherwise None known classified (HNOC) Pharmaceutical related compound of unknown potency. Supplemental information PAGE 2 3. COMPOSITION/INFORMATION ON INGREDIENTS 3.1 SUBSTANCES NO DATA AVAILABLE MOLECULAR FORMULA: C18H31GDN4O9 : H2O MOLECULAR WEIGHT: 604.7 : 18.0 Chemical name Common names and synonyms CAS number Gadolinium 2,2?,2?-[10-[(1RS,2SR)-2,3- dihydroxy-1- NA 198637-52-4 (hydroxymethyl)propyl]-1,4,7,10- tetraazacyclododecane-1,4,7- triyl]triacetate hydrate 4. FIRST-AID MEASURES 4.1 DESCRIPTION OF NECESSARY FIRST-AID MEASURES General advice Medical attention is required. Consult a doctor. Show this safety data sheet (SDS) to the doctor in attendance Inhalation If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for breathing. Call a physician if symptoms develop or persist. Following skin contact Take off contaminated clothing immediately. Wash off with soap and plenty of water. Consult a doctor. Following eye contact Rinse with pure water for at least 15 minutes. Consult a doctor. Following ingestion Rinse mouth with water. Do not induce vomiting. Never give anything by mouth to an unconscious person. Call a doctor or Poison Control Center immediately. 4.2 MOST IMPORTANT SYMPTOMS/EFFECTS, ACUTE AND DELAYED may cause physiological effects PAGE 3 4.3 INDICATION OF IMMEDIATE MEDICAL ATTENTION AND SPECIAL TREATMENT NEEDED, IF NECESSARY Treat symptomatically 5. FIRE-FIGHTING MEASURES 5.1 EXTINGUISHING MEDIA Suitable extinguishing media Water, use dry chemical, carbon dioxide or alcohol-resistant foam. 5.2 SPECIFIC HAZARDS ARISING FROM THE CHEMICAL Carbon oxides, Nitrogen oxides, Hydrogen fluoride, Sulphur oxides 5.3 SPECIAL PROTECTIVE ACTIONS FOR FIRE-FIGHTERS Wear self-contained breathing apparatus for fire fighting if necessary. 6. ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions, protective equipment and emergency procedures Keep unnecessary personnel away. Wear appropriate personal protective equipment. Avoid Inhalation of dust from the spilled material. Do not touch damaged containers or spilled material Unless wearing appropriate protective clothing. Ensure adequate ventilation. 6.2 ENVIRONMENTAL PRECAUTIONS Avoid discharge into drains, water courses or onto the ground. 6.3 METHODS AND MATERIALS FOR CONTAINMENT AND CLEANING UP Avoid the generation of dusts during clean-up. Sweep up or vacuum up spillage and collect in Suitable container for disposal. Clean surface thoroughly to remove residual contamination. For Waste disposal 7. HANDLING AND STORAGE 7.1 Precautions for safe handling Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed PAGE 4 7.2 CONDITIONS FOR SAFE STORAGE, INCLUDING ANY INCOMPATIBILITIES Keep container tightly closed in a dry and well-ventilated place Keep in a dry place. Storage conditions: Refrigernator 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parametersg Occupational Exposure limit values No exposure limits noted for ingredient 8.2 Appropriate engineering controls A laboratory fume hood or other appropriate form of local exhaust ventilations 8.3 Individual protection measures, such as personal protective equipment (PPE) Eye/face protection Wear tightly fitting safety goggles with side-shields conforming to EN 166(EU) or NIOSH (US). Skin protection Wear fire/flame resistant and impervious clothing. Handle with gloves. Gloves must be inspected prior to use. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it. Respiratory protection Recommended respirators are NIOSH-approved N100 or CEN-approved FFP3 particulate respirators. These are to be only used as a backup to local exhaust ventilation or other engineering controls. If the respirator is the only means of protection, a full-face supplied air respirator must be used Thermal hazards Wear appropriate thermal protective clothing, when necessary 9. PHYSICAL AND CHEMICAL PROPERTIES Physical state Colour PAGE 5 Odour Melting point/ freezing point Boiling point or initial boiling point and boiling range Flammability Lower and upper explosion limit / flammability limit Flash point NA Auto-ignition temperature NA Decomposition NA temperature pH Kinematic viscosity Solubility Partition coefficient n- octanol/water Vapour pressure NA Density and/or relative NA density Relative vapour density NA Particle characteristics NA 10. STABILITY AND REACTIVITY 10.1 Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport 10.2 Chemical stability Material is stable under normal conditions 10.3 Possibility of hazardous reactions No dangerous reaction known under conditions of normal use 10.4 Conditions to avoid Contact with incompatible materials 10.5 Incompatible materials Strong oxidizing agents 10.6 Hazardous decomposition products Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions. PAGE 6 11. TOXICOLOGICAL INFORMATION Acute toxicity ORAL LD50: NO DATA AVAILABLE INHALATION: NO DATA AVAILABLE DERMAL: NO DATA AVAILABLE Skin corrosion/irritation No data available Serious eye damage/irritation No data available Respiratory or skin sensitization No data available Germ cell mutagenicity No data available Carcinogenicity No data available Reproductive toxicity No data available STOT-single exposure No data available STOT-repeated exposure No data available Aspiration hazard Based on available data, the classification criteria are not met PAGE 7 12. ECOLOGICAL INFORMATION 12.1 Ecotoxicity There are no data on the ecotoxicity of this product. 12.2 Persistence and degradability No data available 12.3 Bioaccumulative potential No data available 12.4 Mobility in soil No data available 12.5 Other adverse effects No data available 13. DISPOSAL CONSIDERATIONS 13.1 Disposal methods Product Product may be burned in an incinerator equipped with afterburner and scrubber. Excess and expired materials are to be offered to a licensed hazardous material disposal company. Ensure that all Federal and Local regulations regarding the disposal and destruction of this material are followed. Contaminated packaging Dispose of as above. 14. TRANSPORT INFORMATION 14.1 DOT: Not regulated as dangerous goods IATA: Not regulated as dangerous goods 14.2 UN Proper Shipping Name ADR/RID: No data available IMDG: No data available IATA: No data available 14.2 UN Proper Shipping Name ADR/RID: No data available IMDG: No data available IATA: No data available 14.3 Transport hazard class(es) ADR/RID: No data available IMDG: No data available IATA: No data available PAGE 8 14.4 Packing group, if applicable ADR/RID: No data available IMDG: No data available IATA: No data available 14.5 Environmental hazards ADR/RID: No IMDG: No IATA: No 14.6 Special precautions for user No data available 14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code It is the shipper's responsibility to determine the correct transport classification at the time of shipment 15. Regulatory information This product is not known to be a "Hazardous Chemical" as defined by the US federal regulations OSHA Hazard Communication Standard, 29 CFR 1910.1200. TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D) Not regulated. European Union Not regulated. OSHA Specifically Regulated Substances (29 CFR 1910.1001-1052) Not regulated. 16. OTHER INFORMATION Abbreviations and acronyms CAS: CHEMICAL ABSTRACTS SERVICE IATA: INTERNATIONAL AIR TRANSPORTATION ASSOCIATION LD50: LETHAL DOSE 50% Disclaimer: 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. We as supplier shall not be held liable for any damage resulting from handling or from contact with the above product