MATERIAL SAFETY DATA SHEET

Transcription

1 MATERIAL SAFETY DATA SHEET Emergency number: IDENTIFICATION OF PRODUCT This Material Safety Data Sheet applies to: Product Name Part No. HemosIL Factor V Leiden (APC Resistance V) CaCl 2 APTT Reagent APC/CaCl 2 Factor V Reagent Plasma APC Control Plasma Level 1 APC Control Plasma Level 2 2. COMPOSITION INGREDIENT NAME Calcium Chloride: CONCENTRATION PERCENT BY WEIGHT Calcium Chloride dihydrate 0.36 CAS No.: EINECS No.: Risk Code: R36 Tris-hydroxymethyl-aminomethane 0.03 CAS No.: EINECS No Risk Code: R R37: irritating to respiratory system R38: irritating to skin Tris-hydroxymethyl-aminomethane hydrochloride 0.16 CAS No.: EINECS No Risk Code: R R37: irritating to respiratory system R38: irritating to skin Bovine Albumin 0.5 CO Sheet 1 of 5 Part No Rev. 02

2 2. COMPOSITION (CONTINUED) INGREDIENT NAME CONCENTRATION PERCENT BY WEIGHT APTT Reagent: Ciprofloxacin hydrochloride CAS No.: APC/CaCl 2 : Human Activated Protein C Bovine Albumin 0.5 Calcium Chloride Dihydrate 0.36 CAS No.: EINECS No.: Risk Code: R36 R36: irritating to eye Tris-hydroxymethyl-aminomethane (Same as for Calcium Chloride) Tris-hydroxymethyl-aminomethane hydrochloride 0.16 (Same as for Calcium Chloride) Factor V Reagent Plasma: Human Plasma (Lyophilized) APC Control Plasma Level 1: Treated Human Plasma (Lyophilized) APC Control Plasma Level 2: Treated Human Plasma (Lyophilized) 3. HAZARD IDENTIFICATION POTENTIAL HEALTH EFFECTS EYES CaCl 2 / APTT reagent / APC- CaCl 2 : May cause irritation. SKIN CaCl 2 / APTT reagent / APC- CaCl 2 : May cause irritation. INGESTION CaCl 2 / APTT reagent / APC- CaCl 2 : May be harmful if swallowed. INHALATION APTT reagent / APC- CaCl 2 : May cause irritation to the mucous membranes and upper respiratory tract. CO Sheet 2 of 5 Part No Rev. 02

3 4. FIRST AID MEASURES EYES In case of eye contact, flush eyes with plenty of water for at least 15 minutes. Obtain medical attention if irritation develops. SKIN Wash well with soap and water. Remove contaminated clothing and launder before use. Obtain medical attention if irritation develops. INGESTION Flush mouth with water, without swallowing. Obtain medical attention or contact the local Poison Control Center. INHALATION CaCl 2 / APTT reagent / APC- CaCl 2 : Remove the individual to fresh air. If breathing is difficult give oxygen. Obtain medical attention. Factor V Rgt Plasma / APC Control Plasma Level 1-2: None normally required. 5. FIRE FIGHTING MEASURES FLAMMABLE PROPERTIES FLASH POINT LOWER EXPLOSIVE LIMIT (%): Not Applicable UPPER EXPLOSIVE LIMIT (%): Not Applicable FIRE AND EXPLOSION HAZARDS: None known. EXTINGUISHING MEDIA Use any extinguishing agent that is suitable for the surrounding fire. FIRE FIGHTING INSTRUCTIONS Wear self-contained breathing apparatus and protective clothing that is appropriate for fighting a typical fire involving chemical materials. 6. ACCIDENTAL RELEASE MEASURES Wear appropriate personal protective equipment as specified in Section 8. Clean up spills in a manner that does not disperse dust into the air or create aerosols of prepared solutions. Dry spills should be moistened with water or an EPA approved disinfectant. Contain spill and decontaminate the area. Pick up material and dispose in biohazard/sharps container as appropriate. 7. HANDLING AND STORAGE HANDLING AND STORAGE PRECAUTIONS Reference the product labeling for handling and storage instructions. APC- CaCl 2 / Factor V Rgt Plasma / APC Control Plasma Level 1-2 CAUTION: All blood products should be treated as potentially infectious. The human source material was found negative for the presence of the antibody to HIV, HBSAg and HCV when tested in accordance with FDA approved tests. No known test method can offer assurance that products derived from human blood will not transmit infectious agents. Handle as potentially infectious. Wear personal protective equipment. Calcium Chloride / APC- CaCl 2 CAUTION: All blood products should be treated as potentially infectious. The animal serum was tested for the presence of pathologies and found negative. The animal serum was treated during the production processes to inactive viruses. No known test method can offer assurance that products derived from animal blood will not transmit infectious agents. Handle as potentially infectious. Wear personal protective equipment. WORK/HYGIENIC PRACTICES Wash hands with soap and water after use. CO Sheet 3 of 5 Part No Rev. 02

4 8. EXPOSURE CONTROLS/PERSONAL PROTECTION ENGINEERING CONTROLS None normally required. EYE/FACE PROTECTION Safety glasses or splash goggles are recommended. SKIN PROTECTION Wear protective (latex/non-latex) gloves and laboratory coat as required to prevent skin contact. RESPIRATORY PROTECTION None normally required with adequate ventilation. OTHER/GENERAL PROTECTION None normally required. 9. PHYSICAL AND CHEMICAL PROPERTIES APC Control Calcium Chloride APTT Reagent APC/CaCl 2 Plasma Level 1-2 Factor V Rgt Plasma Appearance: liquid liquid lyophilized powder lyophilized powder lyophilized powder Color colorless colorless white white - yellowish yellowish Odor: odorless odorless odorless odorless odorless Density: not applicable not applicable not applicable not applicable not applicable ph: 7.5 at 25 C 7.4 at 25 C 7.5 at 25 C 7.5 at 25 C 7.5 at 25 C BASIC PHYSICAL PROPERTIES VAPOR PRESSURE: Not determined SPECIFIC GRAVITY: Not determined SOLUBILITY (H20): Not determined 10. STABILITY AND REACTIVITY STABILITY: Stable CONDITIONS TO ALLOW (STABILITY): See Insert Sheet. INCOMPATIBLE MATERIALS -Calcium Chloride: methyl vinyl ether, zinc -Tris-hydroxymethyl-aminomethane: copper, brass, aluminum and oxidizing materials. -Ciprofloxacin hydrochloride: oxidizing materials. HAZARDOUS DECOMPOSITION PRODUCTS -Calcium Chloride: oxides of carbon, nitrogen and toxic chlorine fumes may be formed during thermal decomposition. -APTT reagent: oxides of carbon, nitrogen may be formed during thermal decomposition. -APC/CaCl 2 : oxides of carbon, nitrogen and toxic chlorine fumes may be formed during thermal decomposition. -Factor V Rgt Plasma, APC Control Plasma Level 1-2: none known. HAZARDOUS POLYMERIZATION: Will not occur 11. TOXICOLOGICAL INFORMATION MISCELLANEOUS TOXICOLOGICAL INFORMATION -Tris-hydroxymethyl-aminomethane: orl-rat LD mg/kg. No toxic effected noted. (NIOSH). -Calcium Chloride: ipr-musld mg /Kg; orl-rat LD mg/kg (anhydrous form); mutagenic and tumorogenic data (anhydrous form) (NIOSH). The health effects noted above are based on the extrapolation of data on the pure product ingredients. To the best of our knowledge, no health effects have been identified for the product mixture under normal conditions of use, although the health effects of the product have not been thoroughly investigated. CO Sheet 4 of 5 Part No Rev. 02

5 12. ECOLOGICAL INFORMATION OTHER ENVIRONMENTAL INFORMATION Calcium Chloride dry: effect toxic to fish (5100 mg/l) and crustacean (990 mg/l). Use in accordance with good laboratory practice. Do not waste in the environment. 13. DISPOSAL CONSIDERATIONS Based on EEC Directive No. 75/442 and 78/319 and following modifications, the product waste is classified as non-toxic and non-harmful. Dispose of waste product, unused product and contaminated packaging in compliance with federal, state and local regulations. If unsure of the applicable requirements, contact the authorities for information. It is up to the user to classify the waste correctly prior to disposal. 14. TRANSPORT INFORMATION Not regulated. 15. REGULATORY INFORMATION This product is classified and labeled in accordance with EEC Directive 88/379 and EEC Directive 91/155 and following modifications. The health hazard classification has been determined based on composition and hazard data of each ingredient. Physical and health hazard information on the reagent mixture has not been determined. Any physical and health hazard information noted is based on a) evaluation of data of the pure ingredient and b) concentration of each ingredient. Kit Hazard Classification EEC Symbol: Not Applicable Risk Code: Not Applicable. Safety Code: S24/ S24/25: avoid contact with skin and eyes. S29: do not empty into drains. S36: wear suitable protective clothing. 16. OTHER INFORMATION REFERENCE DOCUMENTATION Primary references used in the preparation of this document: 1. Product Specification. 2. Product Insert. NOTE The information supplied in this Material Safety Data Sheet represents the data and best information available at the date of preparation. It is provided with the aim of allowing proper and safe use, storage, transport and disposal of the product. It is not to be considered as a warranty or specification of product quality. It is related to the materials specifically indicated and does not apply if these are used in combination with other materials or during processes not specifically indicated in the text of this Material Safety Data Sheet. CO Sheet 5 of 5 Part No Rev. 02