THEOPHYLLINE, USP (ANHYDROUS) 2.5KG by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name THEOPHYLLINE ANHYDROUS Supplier Information Letco Medical, LLC 1316 Commerce Drive NW Decatur, AL 35601 1 (800) 239-5288 +1 (734) 843-4693 IN CASE OF EMERGENCY: Chemtrec 1 (800) 424-9300 (24 hours) Product Synonym(s) N/A Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Acute toxicity, Oral (Category 3) Signal Word Danger Hazard Statement(s) H301 Toxic if swallowed Pictogram(s) Precautionary Statement(s) P264 Wash hands thoroughly af ter handling. P301+P310 IF SWALLOWED Immediately call a POISON CENTER or doctor/physician. P330 Rinse mouth. P405 Store locked up. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified None Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name 1-H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethylCommon Name Theophylline Anhydrous CAS Number 58-55-9 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from an occupational health physician or other licensed health-care provider f amiliar with workplace chemical exposures. In the United States, the national poison control center phone number is 1-800-222-1222. If person is not breathing, give artif icial respiration. If breathing is dif f icult, give oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention. If Inhaled If dust from the material is inhaled, remove the af f ected person immediately to fresh air. Call a physician if symptoms develop or persist. In Case of Skin Contact Rinse skin with water/shower.Get medical attention if irritation develops and persists. In Case of Eye Contact Rinse with water. Get medical attention if irritation develops and persists. If Swallowed Call a physician or poison control center immediately. Rinse mouth. Do not induce vomiting without advice from poison control center. If vomiting occurs, keep head low so that stomach content doesn't get into the lungs. Do not use mouth-to-mouth method if victim ingested the substance. Induce artif icial respiration with the aid of a pocket mask equipped with a one-way valve or other proper respiratory medical device. Most Important Symptoms and Effects Treatment of overdose should be symptomatic and supportive and may include the f ollowing: DO NOT induce vomiting. Administer activated charcoal as a slurry. Perf orm gastric lavage soon af ter ingestion (within one hour). Protect airway by placement in the Trendelenburg and lef t lateral decubitus position or by endotracheal intubation. In severely poisoned patients, consider multi-dose activated charcoal. Carthartics are NOT recommended. Persistent vomiting may interf ere with activated charcoal administration. Treat with ranitidine, ondansetron, or metoclopramide. In patients with high risk f or seizures, perf orm seizure prophylaxis with phenobarbital. For seizures, administer intravenous diazepam or lorazepam. Monitor f or hypotension, respiratory depression, and need f or endotracheal intubation. For hypotension, administer saline and place in Trendelenburg position. For severe tachycardia with hemodynamic compromise or ischemia, treat with beta blocking agents until hemodialysis or hemoperf usion can be perf ormed. A short-acting cardioselective agent, such as esmolol, is pref erred. Use CAUTION in patients with asthma or COPD. Begin intravenous hydration and replace electrolytes as needed. Obtain serial theophylline levels, f ollow serum electrolytes, Obtain an ECG, and institute continuous cardiac monitoring. For lif e threatening toxicity (signif icant dysrhythmias, hypotension, seizures), treat with hemoperf usion or hemodialysis. [Meditext] Page 1 of 5 Section 5: Fire Fighting Measures Suitable Extinguishing Media Suitable extinguishing media Use f ire-extinguishing media appropriate f or surrounding materials. Water. Foam. Dry chemical or CO2. Unsuitable extinguishing media None known. Special Hazards Arising From the Substance/Mixture No unusual f ire or explosion hazards noted. Special PPE and/or Precautions for Firefighters Wear suitable protective equipment. Use water spray to cool unopened containers. As with all f ires, evacuate personnel to a saf e area. Firef ighters should use self-contained breathing equipment and protective clothing. Use standard f iref ighting procedures and consider the hazards of other involved materials. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Ensure adequate ventilation. Avoid inhalation of dust from the spilled material. Wear appropriate personal protective equipment. Methods and Materials Used for Containment Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surf ace thoroughly to remove residual contamination. Cleanup Procedures Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surf ace thoroughly to remove residual contamination. Section 7: Handling and Storage Precautions for Safe Handling As a general rule, when handling chemicals, avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Clean equipment and work surf aces with suitable detergent or solvent af ter use. Af ter removing gloves, wash hands and other exposed skin thoroughly. Conditions for Safe Storage Store in tight container as def ined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters No biological exposure limits noted f or the ingredient(s). No exposure standards allocated. Appropriate Engineering Controls Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally pref erred to general exhaust because it can control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the ef f ectiveness of engineering controls. Ef f ectiveness of engineering controls intended f or use with highly potent materials should be assessed by use of nontoxic surrogate materials. Local exhaust ventilation such as a laboratory f ume hood or other vented enclosure is recommended, particularly f or grinding, crushing, weighing, or other dust-generating procedures. Handle in accordance with good industrial hygiene and saf ety practice. PPE - Eye/Face Protection Saf ety glasses with sideshields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is pref erred. Maintain eyewash f acilities in the work area. PPE - Skin Protection Chemically compatible gloves. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlatex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy. PPE - Body Protection For handling of laboratory scale quantities, a cloth lab coat is recommended. Where signif icant quantities are handled, work clothing may be necessary to prevent take-home contamination. PPE - Respiratory Protection Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an ef f ective respirator program in place (applicable U.S. regulation OSHA 29 CFR 1910.134). Page 2 of 5 Section 9: Physical and Chemical Properties Appearance White crystalline powder. Upper/Lower Flammability or Explosive Limits No data available Odor Odorless Vapor Pressure < 0.0000001 kPa at 25 °C Odor Threshold Not available. Vapor Density Not available. pH 4 - 6 (2% aqueous solution) Relative Density Not available Melting Point/Freezing Point Melting point/freezing point 518 - 525.2 °F (270 - 274 °C) Solubility Solubility in water Slightly soluble. Solubility (other) Freely soluble in solutions of alkali hydroxides and in ammonia; sparingly soluble in alcohol, in chlorof orm, and in ether. Initial Boiling Point and Boiling Range Not available. Flash Point Not available. Evaporation Rate Not available. Flammability (Solid, Gas) Not applicable. Partition Coefficient Partition coef f icient (n-octanol/water) -0.02 also reported as -0.0076 Auto-Ignition Temperature Not available. Decomposition Temperature Not available. Viscosity Not available. Section 10: Stability and Reactivity Reactivity Not available. Chemical Stability Material is stable under normal conditions. Possibility of Hazardous Reactions No dangerous reaction known under conditions of normal use. Conditions to Avoid None known. Incompatible Materials Alkaline metals. Peroxides. Hazardous Decomposition Products Irritating and/or toxic f umes or gases. Emits toxic f umes under f ire conditions. NOx. Page 3 of 5 Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Mouse 332 mg/kg Acute Toxicity - Inhalation Due to lack of data the classif ication is not possible. Acute Toxicity - Dermal Due to lack of data the classif ication is not possible. Acute Toxicity - Eye Based on available data, the classif ication criteria are not met. Skin Corrosion/Irritation Based on available data, the classif ication criteria are not met. Serious Eye Damage/Irritation Based on available data, the classif ication criteria are not met. Respiratory or Skin Sensitazation Due to lack of data the classif ication is not possible. Germ Cell Mutagenicity Due to lack of data the classif ication is not possible. Data from germ cell mutagenicity tests were not f ound. Carcinogenicity IARC Based on available data, the classif ication criteria are not met. IARC: Group 3; this material is not classif iable as to its carcinogenicity in humans. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Carcinogenicity ACGIH Based on available data, the classif ication criteria are not met. IARC: Group 3; this material is not classif iable as to its carcinogenicity in humans. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Carcinogenicity NTP Based on available data, the classif ication criteria are not met. IARC: Group 3; this material is not classif iable as to its carcinogenicity in humans. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Carcinogenicity OSHA Based on available data, the classif ication criteria are not met. IARC: Group 3; this material is not classif iable as to its carcinogenicity in humans. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Reproductive Toxicity Based on available data, the classif ication criteria are not met. Several large studies of inf ants born to women treated with theophylline during pregnancy showed no increase in birth def ects. 15 mg/kg/day Reproductive study Result: Doserelated increase in birth def ects (clef t palate, skeletal anomalies) in of f spring. Species: Rabbit 259 mg/kg/day Reproductive study Result: No signif icant increase in birth def ects. Species: Rat 396 mg/kg/day Reproductive study Result: No signif icant increase in birth def ects. Species: Mouse Reproductive study (6 to 25 times the human dose) Result: Dose-related increase in birth def ects (clef t palate, skeletal anomalies) observed in of f spring treated at high doses. Species: Rat Specific Target Organ Toxicity - Single Exposure Due to lack of data the classif ication is not possible Specific Target Organ Toxicity - Repeated Exposure Due to lack of data the classif ication is not possible Aspiration Hazard Based on available data, the classif ication criteria are not met. Section 12: Ecological Information Toxicity No ecotoxicity data noted f or the ingredient(s). Persistence and Degradability No data is available on the degradability of this product. Bio-accumulative Potential Not available. Mobility in Soil Not available. Other Adverse Effects Not available. Section 13: Disposal Considerations Waste Treatment Methods Product Dispose in accordance with all applicable regulations. Under RCRA, it is the responsibility of the user of the product to determine, at the time of disposal, whether the product meets RCRA criteria f or hazardous waste. Waste Treatment Methods Packaging Not available. Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a saf e manner (see: Disposal instructions). Contaminated packaging Empty containers should be taken to an approved waste handling site f or recycling or disposal. Since emptied containers may retain product residue, f ollow label warnings even af ter container is emptied. Special Precautions Landfill or Incinerations No data available Other Information No data available Section 14: Transport Information UN Number UN2811 UN Proper Shipping Name Toxic solid, organic, n.o.s. (Theophylline) Transport Hazard Class(es) 6.1 Packaging Group III Environmental Hazards No data available. Page 4 of 5 Section 15: Regulatory Information US f ederal regulations CERCLA/SARA Hazardous Substances - Not applicable. All components are on the U.S. EPA TSCA Inventory List. Superf und Amendments and Reauthorization Act of 1986 (SARA) Hazard categories Immediate Hazard - Yes Delayed Hazard - No Fire Hazard - No Pressure Hazard - No Reactivity Hazard - No SARA 302 Extremely hazardous substance Not listed. SARA 311/312 Hazardous chemical Yes SARA 313 (TRI reporting) Not regulated. Other f ederal regulations Saf e Drinking Water Act (SDWA) Not regulated. Food and Drug Administration (FDA) Not regulated. US state regulations Calif ornia Saf e Drinking Water and Toxic Enf orcement Act of 1986 (Proposition 65): This material is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. US. Calif ornia Proposition 65 Not Listed. International Inventories Country(s) or region Inventory name On inventory (yes/no)* Australia Australian Inventory of Chemical Substances (AICS) Yes Canada Domestic Substances List (DSL) Yes Canada Non-Domestic Substances List (NDSL) No China Inventory of Existing Chemical Substances in China (IECSC) Yes Europe European Inventory of Existing Commercial Chemical Yes Substances (EINECS) Europe European List of Notif ied Chemical Substances (ELINCS) No Japan Inventory of Existing and New Chemical Substances (ENCS) Yes Korea Existing Chemicals List (ECL) Yes New Zealand New Zealand Inventory Yes Country(s) or region Inventory name On inventory (yes/no)* Philippines Philippine Inventory of Chemicals and Chemical Substances Yes (PICCS) United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory Yes *A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s) A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing country(s). Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/09/2019 16:17 Disclaimer Letco Medical, LLC believes that the above information is 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. If the product is used as a component in another product, this information may not be applicable. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED ABOVE. Letco Medical shall not be held liable for any loss or damage resulting from handling, storage, use or from contact with the above product. Page 5 of 5
