Dimension® system LIP Flex® reagent cartridge Lipase Flex® reagent cartridge Dimension® clinical chemistry system Flex® reagent cartridge LIP DF55A Pharmaceutical industry: Diagnostic agents. Material Safety Data Sheet Product name Synonym Material uses Manufactured/supplied Code Product and company identification Dimension® system LIP Flex® reagent cartridge : : : : : 1 . Product type : Liquid. Dade Behring Inc. Corporate Headquarters 1717 Deerfield Road Deerfield, IL 60015-0778 1-847-267-5300 Dade Behring Canada Inc. 1200 Courtneypark Drive East Mississauga, Ontario, Canada L5T-1P2 (905) 564-7333 (800) 264-0083 Transportation: (800) 424-9300 (CHEMTREC) Medical: (800) 228-5635 ext. 284 (Prosar) MSDS no. DEDM0013 Absorbed through skin. Eye contact. Inhalation. Emergency overview Hazards identification Routes of entry Potential acute health effects Severely irritating to the respiratory system. Corrosive to eyes. Harmful if swallowed. May cause burns to mouth, throat and stomach. Corrosive to the skin. Eyes Skin Inhalation Ingestion Physical state Solid Danger! CAUSES EYE AND SKIN BURNS. CAUSES SEVERE RESPIRATORY TRACT IRRITATION. CONTAINS MATERIAL WHICH CAUSES DAMAGE TO THE FOLLOWING ORGANS: LUNGS, RESPIRATORY TRACT, SKIN, EYE, LENS OR CORNEA. MAY BE HARMFUL IF SWALLOWED. Corrosive to eyes and skin. Causes burns. Severely irritating to the respiratory system. Avoid exposure - obtain special instructions before use. Do not breathe vapor or mist. Do not get in eyes or on skin or clothing. Contains material that can cause target organ damage. Use only with adequate ventilation. Keep container tightly closed and sealed until ready for use. Wash thoroughly after handling. : : : : : : : OSHA/HCS status : This material is considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200). 2 . Potential chronic health effects Carcinogenicity : No known significant effects or critical hazards. Mutagenicity : No known significant effects or critical hazards. Teratogenicity : No known significant effects or critical hazards. Developmental effects : No known significant effects or critical hazards. Chronic effects : Contains material that can cause target organ damage. Fertility effects : No known significant effects or critical hazards. Over-exposure signs/symptoms 1/8 DF55A 8/29/2007. Dimension® system LIP Flex® reagent cartridge Hazards identification 2 . See toxicological information (section 11) Ingestion : Adverse symptoms may include the following: stomach pains Skin : Adverse symptoms may include the following: pain or irritation redness blistering may occur Eyes : Adverse symptoms may include the following: pain watering redness Inhalation : Adverse symptoms may include the following: respiratory tract irritation coughing sucrose 57-50-1 93.08 1,3-propanediol, 2-amino-2-(hydroxymethyl)- 77-86-1 21.1 1,3-propanediol, 2-amino-2-(hydroxymethyl)-, hydrochloride 1185-53-1 14.3 poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy- 25322-68-3 5 sodium hydroxide 1310-73-2 4 Composition/information on ingredients Name CAS number % sucrose 57-50-1 93.08 1,3-propanediol, 2-amino-2-(hydroxymethyl)- 77-86-1 21.1 sodium hydroxide 1310-73-2 4 Name CAS number % United States Canada 3 . There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section. Move exposed person to fresh air. Loosen tight clothing such as a collar, tie, belt or waistband. Do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Get medical attention immediately. Get medical attention immediately. Immediately flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Wash clothing before reuse. Get medical attention immediately. Move exposed person to fresh air. Loosen tight clothing such as a collar, tie, belt or waistband. If not breathing, if breathing is irregular or if respiratory arrest occurs, provide artificial respiration or oxygen by trained personnel. The exposed person may need to be kept under medical surveillance for 48 hours. First aid measures Eye contact Skin contact Inhalation Ingestion : : : : 4 . Fire-fighting measures Extinguishing media Non-flammable. 5 . None known. Not suitable : Flammability of the product : In case of fire, use water spray (fog), foam or dry chemical. 2/8 DF55A 8/29/2007. Dimension® system LIP Flex® reagent cartridge Fire-fighting measures 5 . Special protective equipment for fire-fighters Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode. : Hazardous combustion products : Decomposition products may include the following materials: carbon oxides nitrogen oxides sulfur oxides halogenated compounds metal oxide/oxides No action shall be taken involving any personal risk or without suitable training. Evacuate surrounding areas. Keep unnecessary and unprotected personnel from entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist. Provide adequate ventilation. Put on appropriate personal protective equipment (see section 8). Environmental precautions Accidental release measures : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers. Personal precautions : 6 . Stop leak if without risk. Move containers from spill area. Dilute with water and mop up if water-soluble or absorb with an inert dry material and place in an appropriate waste disposal container. Dispose of via a licensed waste disposal contractor. Small spill : Keep container tightly closed. Keep container in a cool, well-ventilated area. Do not ingest. Do not get in eyes or on skin or clothing. Keep container closed. Use only with adequate ventilation. Avoid breathing vapor or mist. Wash thoroughly after handling. Handling and storage Handling Storage : : 7 . sucrose ACGIH (United States, 1996). TWA: 10 mg/m3 ACGIH TLV (United States, 1/2006). Notes: 1996 Adoption Refers to Appendix A -- Carcinogens. TWA: 10 mg/m3 8 hour(s). sodium hydroxide ACGIH TLV (United States, 1/2006). CEIL: 2 mg/m3 Exposure controls/personal protection Product name Exposure limits Consult local authorities for acceptable exposure limits. sucrose ACGIH (United States, 1996). TWA: 10 mg/m³ ACGIH TLV (United States, 1/2007). TWA: 10 mg/m³ 8 hour(s). sodium hydroxide ACGIH TLV (United States, 1/2007). C: 2 mg/m³ United States Canada 8 . Engineering measures : Use only with adequate ventilation. If user operations generate dust, fumes, gas, vapor or mist, use process enclosures, local exhaust ventilation or other engineering controls to keep worker exposure to airborne contaminants below any recommended or statutory limits. Recommended monitoring procedures : If this product contains ingredients with exposure limits, personal, workplace atmosphere or biological monitoring may be required to determine the effectiveness of the ventilation or other control measures and/or the necessity to use respiratory protective equipment. 3/8 DF55A 8/29/2007. Dimension® system LIP Flex® reagent cartridge Exposure controls/personal protection 8 . Use a properly fitted, air-purifying or air-fed respirator complying with an approved standard if a risk assessment indicates this is necessary. Respirator selection must be based on known or anticipated exposure levels, the hazards of the product and the safe working limits of the selected respirator. Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists, gases or dusts. Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product. Personal protection Eyes Skin Respiratory : : : Chemical-resistant, impervious gloves complying with an approved standard should be worn at all times when handling chemical products if a risk assessment indicates this is necessary. Hands : Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before eating, smoking and using the lavatory and at the end of the working period. Appropriate techniques should be used to remove potentially contaminated clothing. Wash contaminated clothing before reusing. Ensure that eyewash stations and safety showers are close to the workstation location. Environmental exposure controls : Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation. In some cases, fume scrubbers, filters or engineering modifications to the process equipment will be necessary to reduce emissions to acceptable levels. Solid Basic. May start to solidify at the following temperature: 0°C (32°F) This is based on data for the following ingredient: water. Weighted average: 1.23 (Water = 1) Highest known value: 2.4 kPa (18 mm Hg) (at 20°C) (water). Amphoteric. (water). Easily soluble in the following materials: cold water. Melting/freezing point Physical and chemical properties Physical state pH Relative density Vapor pressure Ionicity (in water) Solubility : : : : : : : 9 . The product is stable. Under normal conditions of storage and use, hazardous polymerization will not occur. No specific data. Will not occur. Under normal conditions of storage and use, hazardous decomposition products should not be produced. No specific data. Stability and reactivity Stability Conditions to avoid Materials to avoid Hazardous decomposition products Hazardous polymerization : : : : : 10 . Slightly flammable in the presence of the following materials or conditions: oxidizing materials. Non-flammable in the presence of the following materials or conditions: open flames, sparks and static discharge and heat. Slightly explosive in the presence of the following materials or conditions: oxidizing materials. Non-explosive in the presence of the following materials or conditions: open flames, sparks and static discharge. Conditions of reactivity : Flammability Explosibility : 4/8 DF55A 8/29/2007. Dimension® system LIP Flex® reagent cartridge Toxicological information United States Canada 11 . Acute toxicity sucrose LD50 Oral Rat 29700 mg/kg - 1,3-propanediol, 2-amino-2- (hydroxymethyl)- LD50 Intravenous Rat 1800 mg/kg - LD50 Oral Rat 5900 mg/kg - Product/ingredient name Result Species Dose Exposure Acute toxicity 1,3-propanediol, 2-amino-2- (hydroxymethyl)- LD50 Intravenous Rat 1800 mg/kg - LD50 Oral Rat 5900 mg/kg - sucrose LD50 Oral Rat 29700 mg/kg - Product/ingredient name Result Species Dose Exposure Chronic toxicity Not available. Carcinogenicity Not available. Mutagenicity Not available. Teratogenicity Not available. Reproductive toxicity Not available. Chronic toxicity Not available. Carcinogenicity Not available. Mutagenicity Not available. Teratogenicity Not available. Reproductive toxicity Not available. Classification sucrose A4 - - None. - - Product/ingredient name ACGIH EPA NIOSH NTP IARC OSHA Classification sucrose A4 - - None. - - Product/ingredient name ACGIH EPA NIOSH NTP IARC OSHA 5/8 DF55A 8/29/2007. Dimension® system LIP Flex® reagent cartridge Ecological information United States Canada Environmental effects : No known significant effects or critical hazards. 12 . Aquatic ecotoxicity poly(oxy-1,2-ethanediyl), a-hydro-?- hydroxy- - Acute LC50 >20000000 ug/L Fresh water Fish - Carassius carassius 96 hours - Acute LC50 >20000000 ug/L Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 >1000000 ug/L Fresh water Fish - Salmo salar 96 hours sodium hydroxide - Acute EC50 40.38 to 47.13 mg/L Fresh water Daphnia - Ceriodaphnia dubia 48 hours - Acute LC50 125000 ug/L Fresh water Fish - Gambusia affinis 96 hours Product/ingredient name Test Species Result Exposure Biodegradability Not available. Aquatic ecotoxicity sodium hydroxide - Acute EC50 40.38 to 47.13 mg/L Fresh water Daphnia - Ceriodaphnia dubia 48 hours - Acute LC50 125000 ug/L Fresh water Fish - Gambusia affinis 96 hours Product/ingredient name Test Species Result Exposure Biodegradability Not available. The generation of waste should be avoided or minimized wherever possible. Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers. Disposal of this product, solutions and any by-products should at all times comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Waste disposal Disposal considerations Disposal should be in accordance with applicable regional, national and local laws and regulations. : 13 . Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION for additional handling information and protection of employees. Transport information 8 - DOT Classification sodium hydroxide solution (sodium hydroxide) III Regulatory information UN number Proper shipping name Classes PG* Label Additional information 1824 14 . 6/8 DF55A 8/29/2007. Dimension® system LIP Flex® reagent cartridge Transport information 14 . TDG Classification 8 1824 SODIUM HYDROXIDE, SOLUTION (sodium hydroxide) III ADR/RID Class Sodium hydroxide solution (sodium hydroxide) 8 III IMDG Class Sodium hydroxide solution (sodium hydroxide) 8 III Sodium hydroxide solution (sodium hydroxide) 1824 IATA-DGR Class 8 III 1824 1824 - - - - PG* : Packing group Corrosive material Target organ effects HCS Classification Regulatory information U.S. Federal regulations Rhode Island Hazardous Substances: sucrose Pennsylvania RTK Hazardous Substances: sucrose: (generic environmental hazard); sodium hydroxide: (environmental hazard, generic environmental hazard) Minnesota: sucrose; poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy- Massachusetts Substances: sucrose; sodium hydroxide New Jersey: sodium hydroxide United States inventory (TSCA 8b): Not determined. Clean Water Act (CWA) 307: No products were found. Clean Water Act (CWA) 311: sodium hydroxide Clean Air Act (CAA) 112 accidental release prevention: No products were found. Clean Air Act (CAA) 112 regulated flammable substances: No products were found. Clean Air Act (CAA) 112 regulated toxic substances: No products were found. State regulations CEPA DSL: water; sucrose; 1,3-propanediol, 2-amino-2-(hydroxymethyl)-; 1,3- propanediol, 2-amino-2-(hydroxymethyl)-, hydrochloride; poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-; sodium hydroxide WHMIS (Canada) Not a WHMIS controlled material. SARA 302/304/311/312 extremely hazardous substances: No products were found. SARA 302/304 emergency planning and notification: No products were found. SARA 302/304/311/312 hazardous chemicals: sucrose; sodium hydroxide SARA 311/312 MSDS distribution - chemical inventory - hazard identification: sucrose: Delayed (chronic) health hazard; sodium hydroxide: Immediate (acute) health hazard : : : : Canada United States 15 . This product has been classified according to the hazard criteria of the CPR and the MSDS contains all the information required by the CPR. Canadian lists : United States inventory (TSCA 8b) : United States inventory (TSCA 8b): Not determined. Canada inventory : Canada inventory: Not determined. 7/8 DF55A 8/29/2007. Dimension® system LIP Flex® reagent cartridge Other information CAUSES EYE AND SKIN BURNS. CAUSES SEVERE RESPIRATORY TRACT IRRITATION. CONTAINS MATERIAL WHICH CAUSES DAMAGE TO THE FOLLOWING ORGANS: LUNGS, RESPIRATORY TRACT, SKIN, EYE, LENS OR CORNEA. MAY BE HARMFUL IF SWALLOWED. Label requirements : Notice to reader To the best of our knowledge, the information contained herein is accurate. However, neither the above-named supplier, nor any of its subsidiaries, assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist. Date of printing Date of issue Version 8/29/2007. 8/29/2007. 1.05 : : : 16 . The customer is responsible for determining the PPE code for this material. Australia inventory (AICS): All components are listed or exempted. China inventory (IECSC): Not determined. Korea inventory (KECI): Not determined. Philippines inventory (PICCS): Not determined. Japan inventory (ENCS): Not determined. International regulations International lists : S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37/39- Wear suitable protective clothing, gloves and eye/face protection. S45- In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). R34- Causes burns. Risk phrases EU regulations Safety phrases : : Hazard symbol or symbols : 8/8 DF55A 8/29/2007.