TOBR Flex reagent cartridge Tobramycin Flex reagent cartridge Dimension clinical chemistry system Flex reagent cartridge TOBR DF14 Pharmaceutical industry: Diagnostic agents. Material Safety Data Sheet Product name Synonym Material uses Manufactured/supplied Code Product and company identification TOBR 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. DEDM0017 Dermal contact. Eye contact. Inhalation. Emergency overview Hazards identification Routes of entry Potential acute health effects Irritating to respiratory system. Irritating to eyes. Harmful if swallowed. Irritating to skin. May cause sensitization by skin contact. Eyes Skin Inhalation Ingestion Physical state Liquid. Warning! CAUSES RESPIRATORY TRACT, EYE AND SKIN IRRITATION. MAY CAUSE ALLERGIC SKIN REACTION. CONTAINS MATERIAL WHICH CAUSES DAMAGE TO THE FOLLOWING ORGANS: KIDNEYS, LUNGS, NERVOUS SYSTEM, GASTROINTESTINAL TRACT, RESPIRATORY TRACT, SKIN, EYE, LENS OR CORNEA, STOMACH. MAY BE HARMFUL IF SWALLOWED. Harmful if swallowed. Irritating to eyes, respiratory system and skin. May cause sensitization by skin contact. Do not breathe vapor or mist. Do not ingest. Do not get on skin or clothing. Avoid contact with eyes. May cause target organ damage, based on animal data. 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 : May cause target organ damage, based on animal data. Fertility effects : No known significant effects or critical hazards. 1/10 DF14 8/29/2007. TOBR Flex reagent cartridge Hazards identification 2 . See toxicological information (section 11) Over-exposure signs/symptoms Ingestion : No specific data. Skin : Adverse symptoms may include the following: irritation redness Eyes : Adverse symptoms may include the following: pain or irritation watering redness Inhalation : Adverse symptoms may include the following: respiratory tract irritation coughing sodium chloride 7647-14-5 6 sodium hydroxide 1310-73-2 2 boric acid 10043-35-3 1 mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one [ec no. 247-500-7] and 2-methyl-2h- isothiazol-3-one [ec no. 220-239-6] (3:1) 55965-84-9 <0.1 neomycin sulfate 1405-10-3 <0.01 Composition/information on ingredients Name CAS number % sodium hydroxide 1310-73-2 1.34 boric acid 10043-35-3 1.06 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 flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Get medical attention. Flush contaminated skin with plenty of water. Continue to rinse for at least 10 minutes. Remove contaminated clothing and shoes. Wash clothing before reuse. Get medical attention if symptoms appear. 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. Get medical attention. First aid measures Eye contact Skin contact Inhalation Ingestion : : : : 4 . Fire-fighting measures Extinguishing media Aqueous solutions are non-flammable. 5 . None known. Not suitable : Hazardous combustion products : Decomposition products may include the following materials: carbon oxides phosphorus oxides halogenated compounds metal oxide/oxides Flammability of the product : In case of fire, use water spray (fog), foam or dry chemical. 2/10 DF14 8/29/2007. TOBR 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. : 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. Avoid contact with eyes, skin and clothing. Keep container closed. Use only with adequate ventilation. Avoid breathing vapor or mist. Wash thoroughly after handling. Handling and storage Handling Storage : : 7 . sodium hydroxide ACGIH TLV (United States, 1/2006). CEIL: 2 mg/m3 boric acid ACGIH TLV (United States, 1/2006). Notes: Refers to Appendix A -- Carcinogens. Inhalable fraction. See Appendix C, paragraph A. Inhalable Particulate Mass TLVs (IPMTLVs) for those materials that are hazardous when deposited anywhere in the respiratory tract. ACGIH 2005 Adoption STEL: 6 mg/m3 15 minute(s). TWA: 2 mg/m3 8 hour(s). Exposure controls/personal protection Product name Exposure limits Personal protection Consult local authorities for acceptable exposure limits. sodium hydroxide ACGIH TLV (United States, 1/2007). C: 2 mg/m boric acid ACGIH TLV (United States, 1/2007). STEL: 6 mg/m 15 minute(s). TWA: 2 mg/m 8 hour(s). 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. 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. 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. 3/10 DF14 8/29/2007. TOBR 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. 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 : 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. Liquid. Neutral. or Basic. May start to solidify at the following temperature: 0C (32F) This is based on data for the following ingredient: water. Weighted average: 1.8 (Water = 1) Amphoteric. (water). Easily soluble in the following materials: cold water. Melting/freezing point Physical and chemical properties Physical state pH Relative density 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 . Non-flammable in the presence of the following materials or conditions: open flames, sparks and static discharge and heat. Conditions of reactivity : Flammability : Toxicological information United States 11 . Acute toxicity sodium chloride LD50 Dermal Rabbit >10 g/kg - LD50 Intraperitoneal Rat 2600 mg/kg - LD50 Oral Rat 3000 mg/kg - LDLo Intraperitoneal Rat 3.72 g/kg - LDLo Subcutaneous Rat 3500 mg/kg - neomycin sulfate (internal use) LD50 Rat 200 mg/kg - Product/ingredient name Result Species Dose Exposure 4/10 DF14 8/29/2007. TOBR Flex reagent cartridge Toxicological information 11 . Canada Subcutaneous TDLo Intracerebral Rat 714.3 ug/kg - TDLo Intraspinal Rat 36.88 ug/kg - mixture of: 5-chloro-2-methyl-4-isothiazolin- 3-one [EC no. 247-500-7] and 2-methyl- 2H-isothiazol-3-one [EC no. 220-239-6] (3:1) LD50 Oral Rat 53 mg/kg - Acute toxicity Not available. 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 sodium chloride - - - None. - - boric acid A4 - - None. - - Product/ingredient name ACGIH EPA NIOSH NTP IARC OSHA Classification sodium chloride - - - None. - - boric acid A4 - - None. - - Product/ingredient name ACGIH EPA NIOSH NTP IARC OSHA Ecological information United States Environmental effects : No known significant effects or critical hazards. 12 . Aquatic ecotoxicity Product/ingredient name Test Species Result Exposure 5/10 DF14 8/29/2007. TOBR Flex reagent cartridge Ecological information 12 . sodium chloride - Acute EC50 2122.55 to 2644 mg/L Fresh water Daphnia - Ceriodaphnia dubia 48 hours - Acute EC50 402600 to 469200 ug/L Fresh water Daphnia - Daphnia magna 48 hours - Acute LC50 4571 mg/L Fresh water Daphnia - Daphnia magna 48 hours - Acute LC50 6.57 to 6.7 g/L Fresh water Fish - Pimephales promelas 96 hours - Acute LC50 2000 to 2500 mg/L Fresh water Daphnia - Ceriodaphnia dubia 48 hours - Acute LC50 1661 mg/L Fresh water Daphnia - Daphnia magna 48 hours - Acute LC50 5.84 to 6.08 g/L Fresh water Fish - Lepomis macrochirus 96 hours - Acute LC50 3318000 ug/L Fresh water Daphnia - Daphnia magna 48 hours - Acute LC50 3310000 ug/L Fresh water Daphnia - Daphnia magna 48 hours - Acute LC50 1960000 to 2330000 ug/L Fresh water Daphnia - Ceriodaphnia dubia 48 hours - Acute LC50 1294600 ug/L Fresh water Fish - Lepomis macrochirus 96 hours - Acute LC50 1000000 ug/L Fresh water Fish - Morone saxatilis 96 hours - Acute LC50 3.05 to 5.91 g/L Fresh water Daphnia - Daphnia pulex 48 hours - Acute LC50 6094000 to 7824000 ug/L Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 1.47 to 1.57 g/L Fresh water Daphnia - Daphnia pulex 48 hours - Acute LC50 7461 to 9108 mg/L Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 5000000 ug/L Fresh water Fish - Morone saxatilis 96 hours - Acute LC50 6094 to 7824 mg/L Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 6180000 ug/L Fresh water Fish - Goldfish - Carassius auratus 96 hours - Acute LC50 6170000 ug/L Fresh water Fish - Goldfish - Carassius auratus 96 hours 6/10 DF14 8/29/2007. TOBR Flex reagent cartridge Ecological information 12 . Canada 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 boric acid - Acute EC50 777 to 932 ppm Fresh water Daphnia - Daphnia magna 48 hours - Acute EC50 226 to 246 ppm Fresh water Daphnia - Daphnia magna 48 hours - Acute EC50 133 to 153 ppm Fresh water Daphnia - Daphnia magna 48 hours - Acute LC50 >1100 ppm Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 >1021 ppm Fresh water Fish - Lepomis macrochirus 96 hours - Acute LC50 >800 ppm Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 5600 ppm Fresh water Fish - Gambusia affinis 96 hours - Acute LC50 50 to 100 ppm Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 >100000 ug/L Fresh water Fish - Gila elegans 96 hours - Acute LC50 >100000 ug/L Fresh water Fish - Ptychocheilus lucius 96 hours - Acute LC50 233000 to 293000 ug/L Fresh water Fish - Xyrauchen texanus 96 hours - Acute LC50 125000 to 162000 ug/L Fresh water Fish - Catostomus latipinnis 96 hours - Acute LC50 >100000 ug/L Fresh water Fish - Xyrauchen texanus 96 hours Biodegradability Not available. Aquatic ecotoxicity Product/ingredient name Test Species Result Exposure 7/10 DF14 8/29/2007. TOBR Flex reagent cartridge Ecological information 12 . 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 boric acid - Acute EC50 777 to 932 ppm Fresh water Daphnia - Daphnia magna 48 hours - Acute EC50 226 to 246 ppm Fresh water Daphnia - Daphnia magna 48 hours - Acute EC50 133 to 153 ppm Fresh water Daphnia - Daphnia magna 48 hours - Acute LC50 >1100 ppm Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 >1021 ppm Fresh water Fish - Lepomis macrochirus 96 hours - Acute LC50 >800 ppm Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 5600 ppm Fresh water Fish - Gambusia affinis 96 hours - Acute LC50 50 to 100 ppm Fresh water Fish - Oncorhynchus mykiss 96 hours - Acute LC50 >100000 ug/L Fresh water Fish - Gila elegans 96 hours - Acute LC50 >100000 ug/L Fresh water Fish - Xyrauchen texanus 96 hours - Acute LC50 233000 to 293000 ug/L Fresh water Fish - Xyrauchen texanus 96 hours - Acute LC50 125000 to 162000 ug/L Fresh water Fish - Catostomus latipinnis 96 hours - Acute LC50 >100000 ug/L Fresh water Fish - Ptychocheilus lucius 96 hours 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. 8/10 DF14 8/29/2007. TOBR Flex reagent cartridge Transport information 8 - No additional remark. DOT Classification TDG Classification 8 Sodium hydroxide solution (sodium hydroxide) III 1824 Sodium hydroxide solution (sodium hydroxide) III ADR/RID Class Sodium hyroxide solution (sodium hydroxide) 8 III IMDG Class Sodium hydroxide solution (sodium hydroxide) 8 III Sodium hydroxide solution (sodium hydroxide) 1824 IATA-DGR Class 8 Regulatory information UN number Proper shipping name Classes PG* Label Additional information III 1824 1824 - - - 1824 - 14 . PG* : Packing group Irritating material Sensitizing material Target organ effects HCS Classification Regulatory information U.S. Federal regulations Rhode Island Hazardous Substances: borates, tetra, sodium salts- decahydrate Pennsylvania RTK Hazardous Substances: sodium hydroxide: (environmental hazard, generic environmental hazard); borates, tetra, sodium salts- decahydrate: (generic environmental hazard), generic environmental hazard) Florida: borates, tetra, sodium salts- decahydrate Minnesota: borates, tetra, sodium salts- decahydrate Massachusetts Substances: sodium hydroxide; borates, tetra, sodium salts- decahydrat Massachusetts SpillNew Jersey: sodium hydroxide; borates, tetra, sodium salts- decahydrate TSCA 8(b) inventory: water; sodium chloride; sodium hydroxide; boric acid; neomycin sulfate 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 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: sodium chloride; sodium hydroxide; boric acid SARA 311/312 MSDS distribution - chemical inventory - hazard identification: sodium chloride: Immediate (acute) health hazard, Delayed (chronic) health hazard; sodium hydroxide: Immediate (acute) health hazard; boric acid: Immediate (acute) health hazard, Delayed (chronic) health hazard : : : United States 15 . California Prop. 65 9/10 DF14 8/29/2007. TOBR Flex reagent cartridge Regulatory information 15 . WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm. CEPA DSL: water; sodium chloride; sodium hydroxide; boric acid WHMIS (Canada) Not a WHMIS controlled material. : Canada neomycin sulfate No. Yes. No. No. Ingredient name Cancer Reproductive No significant risk level Maximum acceptable dosage level 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. Other information CAUSES RESPIRATORY TRACT, EYE AND SKIN IRRITATION. MAY CAUSE ALLERGIC SKIN REACTION. CONTAINS MATERIAL WHICH CAUSES DAMAGE TO THE FOLLOWING ORGANS: KIDNEYS, LUNGS, NERVOUS SYSTEM, GASTROINTESTINAL TRACT, RESPIRATORY TRACT, SKIN, EYE, LENS OR CORNEA, STOMACH. 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. 1.03 : : : 16 . The customer is responsible for determining the PPE code for this material. Australia inventory (AICS): Not determined. China inventory (IECSC): Not determined. Korea inventory (KECI): Not determined. Philippines inventory (PICCS): Not determined. Japan inventory (ENCS): Not determined. International regulations International lists : S24- Avoid contact with skin. S37- Wear suitable gloves. R36/38- Irritating to eyes and skin. R43- May cause sensitization by skin contact. Risk phrases EU regulations Safety phrases : : Hazard symbol or symbols : 10/10 DF14 8/29/2007.