***MATERIAL SAFETY DATA SHEET***

Transcription

1 ***MATERIAL SAFETY DATA SHEET*** SECTION 1: PRODUCT AND COMPANY IDENTIFICATION PRODUCT NAME: CONSULT hcg Pregnancy Test REORDER #: 5000 (Dipstick); 5001 (Cassette); 5002 (Combo Cassette) DISTRIBUTED BY: McKesson Medical-Surgical Inc Landmark Road Richmond, VA LINE: EMERGENCY PHONE: (CHEMTREC) PRODUCT DESCRIPTION: In vitro diagnostic medical device. Test strip impregnated with dried chemical / biochemical reagents. For professional use only. SECTION 2: COMPOSITION/ OF INGREDIENTS INGREDIENT CAS NO. EINECS NO. CLASSIFICATION CONCENTRATION % Tris (hydroxymethyl) aminomethane Xi, R 36/37/38 2 5% Sodium Carbonate Xi, R % Triton X Xn (Xi), R % SECTION 2 NOTES: Preparation not classified as dangerous according to Directive 1999/45/EC. This device does not contain reportable quantities of hazardous chemicals. Each device is packaged in a foil pouch. ROUTES OF ENTRY: POTENTIAL HEALTH EFFECTS EYES: SKIN: INGESTION: INHALATION: ACUTE HEALTH HAZARDS: CHRONIC HEALTH HAZARDS: SECTION 3: HAZARDS IDENTIFICATION MEDICAL CONDITIONS GENERALLY AGGRAVATED BY EXPOSURE: CARCINOGENICITY OSHA: ACGIH: NTP: IARC: OTHER: SECTION 3 NOTES: SECTION 4: FIRST-AID MEASURES The following first aid measures are only relevant in the event of serious misuse, whereby the device is disassembled and there is exposure to the chemicals in the test stip. EYES: Rinse opened eye for several minutes under running water. SKIN: Wash with soap and water and rinse thoroughly. INGESTION: If desiccant or other components are swallowed seek medical attention. Page 1

2 INHALATION: NOTES TO PHYSICIANS OR FIRST AID PROVIDERS: SECTION 4 NOTES: FLAMMABLE LIMITS IN AIR, UPPER: (% BY VOLUME) LOWER: FLASH POINT: METHOD USED: AUTOIGNITION TEMPERATURE: Not self-igniting SECTION 5: FIRE-FIGHTING MEASURES NFPA HAZARD CLASSIFICATION HEALTH: FLAMMABILITY: REACTIVITY: OTHER: HMIS HAZARD CLASSIFICATION HEALTH: FLAMMABILITY: REACTIVITY: PROTECTION: EXTINGUISHING MEDIA: CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam. Use fireextinguishing methods suitable to surrounding conditions. SPECIAL FIRE FIGHTING PROCEDURES: Wear full protective suit and self-contained breathing respiratory device when extinguishing fires. UNUSUAL FIRE AND EXPLOSION HAZARDS: The device contains combustible materials. This product does not present an explosion hazard. HAZARDOUS DECOMPOSITION PRODUCTS: In case of fire, the following can be released: hazardous fumes and vapors, Carbon oxides (COx), Nitrogen oxides (NOx) SECTION 5 NOTES: SECTION 6: ACCIDENTAL RELEASE MEASURES ACCIDENTAL RELEASE MEASURES: Collect materials and dispose of as waste according to Section 13 SECTION 6 NOTES: Avoid release to the environment. Refer to Section 8 for protective measures when handling the spillage. HANDLING: STORAGE: Store in the original container at 2 30 C OTHER PRECAUTIONS: Keep out of reach of children SECTION 7 NOTES: ENGINEERING CONTROLS: VENTILATION: RESPIRATORY PROTECTION: Not required SECTION 7: HANDLING AND STORAGE SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION Page 2

3 EYE PROTECTION: Not required SKIN PROTECTION: Latex/natural rubber disposable gloves (for sample handling); Lab coat. NOTE: Glove resistance is not critical as the gloves are intended to provide protection against the sample material. OTHER PROTECTIVE CLOTHING OR EQUIPMENT: WORK HYGIENIC PRACTICES: Adhere to good laboratory practices (GLP). Wash hands before breaks and at the end of work. EXPOSURE GUIDELINES: The product does not contain any relevant quantities of materials with critical values that have to be monitored in the workplace. SECTION 8 NOTES: SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES APPEARANCE & ODOR: Laminated test strip, which may be housed in a plastic holder; odorless PHYSICAL STATE: The device is an article containing solid components ph AS SUPPLIED: ph (Other: BOILING POINT: MELTING POINT: FREEZING POINT: VAPOR PRESSURE (mmhg): VAPOR DENSITY (AIR = 1): SPECIFIC GRAVITY (H2O = 1): EVAPORATION RATE: BASIS (=1): SOLUBILITY IN WATER: PERCENT SOLIDS BY WEIGHT: PERCENT VOLATILE: BY WT/ BY VOL VOLATILE ORGANIC COMPOUNDS (VOC): WITH WATER: LBS/GAL WITHOUT WATER: LBS/GAL MOLECULAR WEIGHT: N/ A SECTION 9 NOTES: SECTION 10: STABILITY AND REACTIVITY STABLE UNSTABLE STABILITY: X Page 3

4 CONDITIONS TO AVOID (STABILITY): INCOMPATIBILITY (MATERIAL TO AVOID): None HAZARDOUS DECOMPOSITION OR BY-PRODUCTS: No dangerous decomposition products known HAZARDOUS POLYMERIZATION: CONDITIONS TO AVOID (POLYMERIZATION): SECTION 10 NOTES: SECTION 11: TOXICOLOGICAL TOXICOLOGICAL : No irritating effects anticipated after skin or eye contact; No sensitizing effects known SECTION 11 NOTES: SECTION 12: ECOLOGICAL ECOLOGICAL : Quantitative data on the toxic effects of this product is not available. The device contains plastic and other components that are not readily degradable. SECTION 12 NOTES: SECTION 13: DISPOSAL CONSIDERATIONS WASTE DISPOSAL METHOD: Used devices and other contaminated materials should be disposed of as potentially bio-hazardous waste. To ensure compliance with anti-pollution and other laws of the country concerned, we recommend that you contact the relevant (local) authorities and/or an approved waste-disposal company for information. Disposal must be made in accordance with local waste management regulations. Non-contaminated packaging materials may be recycled. Contact your local service providers for further information. RCRA HAZARD CLASS: SECTION 13 NOTES: U.S. DEPARTMENT OF TRANSPORTATION PROPER SHIPPING NAME: HAZARD CLASS: DOT SHIPPING ID NUMBER: DOT PACKING GROUP: DOT LABEL STATEMENT: WATER TRANSPORTATION PROPER SHIPPING NAME: HAZARD CLASS: ID NUMBER: PACKING GROUP: LABEL STATEMENTS: SECTION 14: TRANSPORT AIR TRANSPORTATION PROPER SHIPPING NAME: HAZARD CLASS: ID NUMBER: Page 4

5 PACKING GROUP: LABEL STATEMENTS: SECTION 14 NOTES: Not regulated for transport. U.S. FEDERAL REGULATIONS TSCA (TOXIC SUBSTANCE CONTROL ACT): SECTION 15: REGULATORY SARA SECTION 355 (EXTREMELY HAZARDOUS SUBSTANCES): Sodium azide SARA SECTION 313 (SPECIFIC TOXIC CHEMICAL LISTINGS): Sodium azide CERCLA (COMPREHENSIVE RESPONSE COMPENSATION, AND LIABILITY ACT): 311/312 HAZARD CATEGORIES: 313 REPORTABLE INGREDIENTS: STATE REGULATIONS: INTERNATIONAL REGULATIONS: SECTION 15 NOTES: OTHER : PREPARATION : SECTION 16: OTHER DISCLAIMER: This information relates onto to the specific material designated and may not be valid for such material used in combination with any other materials or in any process. The information and recommendations contained herein are to the best of the manufacturer s knowledge and belief accurate and reliable as of the date indicated. No representation warranty or guarantee, however, is made with regards to accuracy, reliability or completeness. Conditions of use of the material are under the control of the user; therefore, it is the user s responsibility to satisfy itself as to the suitability and completeness of such information for its own particular use. Appropriate warnings and safe-handling procedures should be provided to handlers and users. Page 5