BACLOFEN, USP 500GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name BACLOFEN USP 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) C10-H12-Cl-N-O2, "benzenepropanoic acid, beta-(aminomethyl)-4-chloro-", "beta-(aminomethyl)-4- chlorobenzenepropanoic acid", "hydrocinnamic acid, beta-(aminomethyl)-p-chloro-", "beta-(aminomethyl)- pchlorohydrocinnamic acid", "gamma-amino-beta-(p-chlorophenyl)butyric acid", "beta-(pchlorophenylgammaaminobutyric acid", beta-(4-chlorophenyl)GABA, "4-amino-3-(3-4-chlorophenyl)butanoic acid", BA34647, C-34647BA, "Ciba Ba 34647", Lioresal, Baclon, "muscle relaxant" Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Acute Toxicity Category 3, Eye Irritation Category 2A, Reproductive Toxicity Category 1B, Respiratory Sensitizer Category 1, Skin Corrosion/Irritation Category 2, Skin Sensitizer Category 1, STOT - SE Category 3 Signal Word Danger Hazard Statement(s) H301 Toxic if swallowed H315 Causes skin irritation H317 May cause an allergic skin reaction H319 Causes serious eye irritation H334 May cause allergy or asthma symptoms or breathing dif f iculties if inhaled H335 May cause respiratory irritation H360 May damage f ertility or the unborn child Pictogram(s) Precautionary Statement(s) P201 Obtain special instructions bef ore use. P202 Do not handle until all saf ety precautions have been read and understood. P261 Avoid breathing dust/f ume/gas/mist/vapours/spray. P264 Wash hands thoroughly af ter handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P272 Contaminated work clothing should not be allowed out of the workplace. P280 Wear protective gloves/protective clothing/eye protection/f ace protection. P281 Use personal protective equipment as required. P285 In case of inadequate ventilation wear respiratory protection. P301+P310 IF SWALLOWED Immediately call a POISON CENTER or doctor/physician. P302+P352 IF ON SKIN Wash with soap and water. P304+P340 IF INHALED Remove victim to fresh air and keep at rest in a position comf ortable f or breathing. P304+P341 IF INHALED If breathing is dif f icult, remove victim to fresh air and keep at rest in a position comf ortable f or breathing. P305+P351+P338 IF IN EYES Rinse cautiously with water f or several minutes. Remove contact lenses if present and easy to do. continue rinsing. P308+P313 IF exposed or concerned Get medical advice/attention. P312 Call a POISON CENTER or doctor/physician if you f eel unwell. P330 Rinse mouth. P333+P313 If skin irritation or a rash occurs Get medical advice/attention. P337+P313 If eye irritation persists Get medical advice/attention. P342+P311 If experiencing respiratory symptoms Call a POISON CENTER or doctor/physician. P363 Wash contaminated clothing bef ore reuse. P403+P233 Store in a well ventilated place. Keep container tightly closed. P405 Store locked up. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified No data Available Ingredient(s) with Unknown Toxicity No data Available Page 1 of 7 Section 3: Composition/Information on Ingredients Chemical Name Baclof en Common Name Baclof en CAS Number 1134-47-0 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice NOTES TO PHYSICIAN Treat symptomatically. For poisons (where specif ic treatment regime is absent):Basic Treatment: Establish a patent airway with suction where necessary. �????�???�??�?· Watch f or signs of respiratory insuf f iciency and assist ventilation as necessary. �????�???�??�?· Administer oxygen by non-rebreather mask at 10 to 15 L/min. �????�???�??�?· Monitor and treat, where necessary, f or pulmonary oedema. Baclof en is rapidly absorbed from the gastrointestinal tract and is primarily excreted unchanged in the urine. If Inhaled If f umes or combustion products are inhaled remove from contaminated area. Lay patient down. Keep warm and rested. Prostheses such as f alse teeth, which may block airway, should be removed, where possible, prior to initiating f irst aid procedures. Apply artif icial respiration if not breathing, pref erably with a demand valve resuscitator, bag-valve mask device, or pocket mask as trained. Perf orm CPR if necessary. In Case of Skin Contact If skin contact occurs: Immediately remove all contaminated clothing, including f ootwear. Flush skin and hair with running water (and soap if available). Seek medical attention in event of irritation. In Case of Eye Contact If this product comes in contact with the eyes: Immediately hold eyelids apart and f lush the eye continuously with running water. Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally lif ting the upper and lower lids. Continue f lushing until advised to stop by the Poisons Inf ormation Centre or a doctor, or f or at least 15 minutes. Transport to hospital or doctor without delay. If Swallowed Give slurry of activated charcoal in water to drink. NEVER GIVE AN UNCONSCIOUS PATIENT WATER TO DRINK. At least 3 tablespoons in a glass of water should be given. Although induction of vomiting may be recommended (IN CONSCIOUS PERSONS ONLY), such a f irst aid measure is dissuaded due to the risk of aspiration of stomach contents. (i) It is better to take the patient to a doctor who can decide on the necessity and method of emptying the stomach. (ii) Special circumstances may however exist; these include non- availability of charcoal and the ready availability of the doctor. NOTE: If vomiting is induced, lean patient f orward or place on lef t side (head-down position, if possible) to maintain open airway and prevent aspiration. Most Important Symptoms and Effects Inhaled: Evidence shows, or practical experience predicts, that the material produces irritation of the respiratory system, in a substantial number of individuals, f ollowing inhalation. Ingestion: Toxic ef f ects may result from the accidental ingestion of the material; animal experiments indicate that ingestion of less than 40 gram may be f atal or may produce serious damage to the health of the individual. Side ef f ect of skeletal muscle relaxants may include: Sedation, drowsiness, Blurred or double vision, constipation or diarrhea, Impairment of mental and physical abilities required f or driving or operating hazardous machinery. Skin Contact: Skin contact is not thought to have harmf ul health ef f ects (as classif ied under EC Directives); the material may still produce health damage f ollowing entry through wounds, lesions or abrasions. the material may cause eye irritation in a substantial number of individuals and/or may produce signif icant ocular lesions which are present twentyf our hours or more af ter instillation into the eye(s) of experimental animals. Repeated or prolonged eye contact may cause inf lammation characterised by temporary redness (similar to windburn) of the conjunctiva (conjunctivitis); temporary impairment of vision and/or other transient eye damage/ulceration may occur. Chronic: �?????�????�???�??�?· Long-term exposure to respiratory irritants may result in disease of the airways involving dif f icult breathing and related systemic problems. There is suf f icient evidence to provide a strong presumption that human exposure to the material may result in developmental toxicity. Section 5: Fire Fighting Measures Suitable Extinguishing Media Foam, Dry chemical powder, BCF (where regulations permit). Carbon dioxide. Special Hazards Arising From the Substance/Mixture Combustible solid which burns but propagates f lame with dif f iculty; it is estimated that most organic dusts are combustible (circa 70%) - according to the circumstances under which the combustion process occurs, such materials may cause f ires and / or dust explosions. Avoid generating dust, particularly clouds of dust in a conf ined or unventilated space as dusts may f orm an explosive mixture with air, and any source of ignition, i.e. f lame or spark, will cause f ire or explosion. Dust clouds generated by the f ine grinding of the solid are a particular hazard; accumulations of f ine dust (420 micron or less) may burn rapidly and f iercely if ignited - particles exceeding this limit will generally not f orm f lammable dust clouds; once initiated, however, larger particles up to 1400 microns diameter will contribute to the propagation of an explosion. In the same way as gases and vapours, dusts in the f orm of a cloud are only ignitable over a range of concentrations; in principle, the concepts of lower explosive limit (LEL) and upper explosive limit (UEL).are applicable to dust clouds but only the LEL is of practical use; - this is because of the inherent dif f iculty of achieving homogeneous dust clouds at high temperatures (f or dusts the LEL is of ten called the "Minimum Explosible Concentration", MEC). Combustion products include: carbon monoxide (CO) carbon dioxide (CO2) hydrogen chloride phosgene nitrogen oxides (NOx) other pyrolysis products typical of burning organic material May emit poisonous f umes. FIRE INCOMPATIBILITY Avoid contamination with oxidising agents i.e. nitrates, oxidising acids, chlorine bleaches, pool chlorine etc. as ignition may result Special PPE and/or Precautions for Firefighters FIRE FIGHTING Alert Fire Brigade and tell them location and nature of hazard. Wear breathing apparatus plus protective gloves f or f ire only. Prevent, by any means available, spillage from entering drains or water courses. Use f ire f ighting procedures suitable f or surrounding area. Page 2 of 7 Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Wear f ull body protective clothing with breathing apparatus. Methods and Materials Used for Containment MINOR SPILLS Clean up all spills immediately. Avoid contact with skin and eyes. Wear protective clothing, gloves, saf ety glasses and dust respirator. Use dry clean up procedures and avoid generating dust. MAJOR SPILLS Clear area of personnel and move upwind. Alert Fire Brigade and tell them location and nature of hazard. Prevent, by any means available, spillage from entering drains or water course. Wear f ull body protective clothing with breathing apparatus. Cleanup Procedures MINOR SPILLS Clean up all spills immediately. Avoid contact with skin and eyes. Wear protective clothing, gloves, saf ety glasses and dust respirator. Use dry clean up procedures and avoid generating dust. MAJOR SPILLS Clear area of personnel and move upwind. Alert Fire Brigade and tell them location and nature of hazard. Prevent, by any means available, spillage from entering drains or water course. Wear f ull body protective clothing with breathing apparatus. Section 7: Handling and Storage Precautions for Safe Handling Avoid all personal contact, including inhalation. Wear protective clothing when risk of exposure occurs. Use in a wellventilated area. Prevent concentration in hollows and sumps. Organic powders when f inely divided over a range of concentrations regardless of particulate size or shape and suspended in air or some other oxidizing medium may f orm explosive dust-air mixtures and result in a f ire or dust explosion (including secondary explosions) Minimise airborne dust and eliminate all ignition sources. Keep away from heat, hot surf aces, sparks, and f lame. Establish good housekeeping practices. Remove dust accumulations on a regular basis by vacuuming or gentle sweeping to avoid creating dust clouds. Conditions for Safe Storage Avoid reaction with oxidising agents. Store in original containers. Keep containers securely sealed. Store in a cool, dry, well-ventilated area. Store away from incompatible materials and f oodstuf f containers. Page 3 of 7 Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Baclof en: CAS: 1134-47-0 (No OEL data Available at present). Appropriate Engineering Controls To prevent contamination and overexposure, no open handling of powder should be allowed. Powder handling operations are to be done in a powders weighing hood, a glove box, or other equivalent ventilated containment system. In situations where these ventilated containment hoods have not been installed, a non-ventilated enclosed containment hood should be used. Pending changes resulting from additional air monitoring data, up to 300 mg can be handled outside of an enclosure provided that no grinding, crushing or other dust-generating process occurs. An air-purif ying respirator should be worn by all personnel in the immediate area in cases where nonventilated containment is used, where signif icant amounts of material (e.g., more than 2 grams) are used, or where the material may become airborne (as through grinding, etc.). Enclosed local exhaust ventilation is required at points of dust, f ume or vapour generation. HEPA terminated local exhaust ventilation should be considered at point of generation of dust, f umes or vapours. When handling quantities up to 500 gram in either a standard laboratory with general dilution ventilation (e.g. 6-12 air changes per hour) is pref erred. Quantities up to 1 kilogram may require a designated laboratory using f ume hood, biological saf ety cabinet, or approved vented enclosures. Quantities exceeding 1 kilogram should be handled in a designated laboratory or containment laboratory using appropriate barrier/ containment technology. PPE - Eye/Face Protection For laboratory, larger scale or bulk handling or where regular exposure in an occupational setting occurs: Chemical goggles Face shield. Full f ace shield may be required f or supplementary but never f or primary protection of eyes Contact lenses may pose a special hazard; sof t contact lenses may absorb and concentrate irritants. A written policy document, describing the wearing of lens or restrictions on use, should be created f or each workplace or task. This should include a review of lens absorption and adsorption f or the class of chemicals in use and an account of injury experience. Medical and f irst-aid personnel should be trained in their removal and suitable equipment should be readily available. In the event of chemical exposure, begin eye irrigation immediately and remove contact lens as soon as practicable. Lens should be removed at the f irst signs of eye redness or irritation - lens should be removed in a clean environment only af ter workers have washed hands thoroughly. [CDC NIOSH Current Intelligence Bulletin 59], [AS/NZS 1336 or national equivalent]. PPE - Skin Protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching gloves outer surf ace) to avoid skin contact with this product. Dispose of contaminated gloves af ter use in accordance with applicable laws and good laboratory practices. Wash and dry hands. Complete suit protecting against chemicals, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specif ic workplace. PPE - Body Protection HANDS/FEET The material may produce skin sensitisation in predisposed individuals. Care must be taken, when removing gloves and other protective equipment, to avoid all possible skin contact. Contaminated leather items, such as shoes, belts and watch-bands should be removed and destroyed. Select gloves tested to a relevant standard (e.g. Europe EN 374, US F739, AS/NZS 2161.1 or national equivalent). When prolonged or frequently repeated contact may occur, a glove with a protection class of 5 or higher (breakthrough time greater than 240 minutes according to EN 374, AS/NZS 2161.10.1 or national equivalent) is recommended. When only brief contact is expected, a glove with a protection class of 3 or higher (breakthrough time greater than 60 minutes according to EN 374, AS/NZS 2161.10.1 or national equivalent) is recommended. Contaminated gloves should be replaced. Suitability and durability of glove type is dependent on usage. Important f actors in the selection of gloves include: such as: Frequency and duration of contact, Chemical resistance of glove material, Glove thickness and Dexterity. Rubber gloves (nitrile or low-protein, powder-free latex). Employees allergic to latex gloves should use nitrile gloves in pref erence. Double gloving should be considered. PVC gloves. Protective shoe covers [AS/NZS 2210]. Change gloves frequently and when contaminated, punctured or torn. BODY/OTHER MEANS OF PROTECTION For quantities up to 500 grams a laboratory coat may be suitable. For quantities up to 1 kilogram a disposable laboratory coat or coverall of low permeability is recommended. Coveralls should be buttoned at collar and cuf f s. For quantities over 1 kilogram and manuf acturing operations, wear disposable coverall of low permeability and disposable shoe covers. For manuf acturing operations, air-supplied f ull body suits may be required f or the provision of advanced respiratory protection. PPE - Respiratory Protection Particulate. (AS/NZS 1716 & 1715, EN 143:2000 & 149:2001, ANSI Z88 or national equivalent). Respirators may be necessary when engineering and administrative controls do not adequately prevent exposures. The decision to use respiratory protection should be based on prof essional judgment that takes into account toxicity inf ormation, exposure measurement data, and frequency and likelihood of the worker's exposure - ensure users are not subject to high thermal loads which may result in heat stress or distress due to personal protective equipment (powered, positive f low, f ull f ace apparatus may be an option). Published occupational exposure limits, where they exist, will assist in determining the adequacy of the selected respiratory. These may be government mandated or vendor recommended. Certif ied respirators will be usef ul f or protecting workers from inhalation of particulates when properly selected and f it tested as part of a complete respiratory protection program. Page 4 of 7 Section 9: Physical and Chemical Properties Appearance White or creamy-white, odourless, crystalline powder Upper/Lower Flammability or Explosive Limits Not Available Odor No data available Vapor Pressure Negligible Odor Threshold No data available Vapor Density No data available pH Not Applicable Relative Density Not Applicable Melting Point/Freezing Point Melting/freezing range (�C) 206-208 Solubility Does not mix well with water. Soluble in dilute mineral acids and alkali hydroxides. Solubility in water (g/L) Partly miscible Initial Boiling Point and Boiling Range Not applicable Flash Point Not available Evaporation Rate Not applicable Flammability (Solid, Gas) No data available Partition Coefficient No data available Auto-Ignition Temperature Not Available Decomposition Temperature Not Available Viscosity Not Applicable Section 10: Stability and Reactivity Reactivity Stable under normal conditions. Chemical Stability Stable under normal conditions. Possibility of Hazardous Reactions None under normal conditions. Conditions to Avoid Moisture. Heat. Incompatible Materials Strong oxidizers. Nitric acid Hazardous Decomposition Products When heated to decomposition, emits dangerous f umes. Carbon monoxide. Chlorides. Carbon dioxide. Nitrogen oxides. Hazardous polymerization : Will not occur. Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Oral - rat- 145 mg/kg Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation No data available Serious Eye Damage/Irritation No data available Respiratory or Skin Sensitazation May cause sensitization by inhalation and skin contact. Germ Cell Mutagenicity No data available Carcinogenicity IARC No data available. Carcinogenicity ACGIH No data available. Carcinogenicity NTP No data available. Carcinogenicity OSHA No data available. Reproductive Toxicity Toxic f or reproduction : unborn child: Category 3: Substances which cause concern f or humans owing to possible developmental toxic ef f ects. Specific Target Organ Toxicity - Single Exposure No data available. Specific Target Organ Toxicity - Repeated Exposure No data available Aspiration Hazard No data available Page 5 of 7 Section 12: Ecological Information Toxicity No data available Persistence and Degradability No data available Bio-accumulative Potential No data available Mobility in Soil No data available Other Adverse Effects No data available Section 13: Disposal Considerations Waste Treatment Methods Product Containers may still present a chemical hazard/ danger when empty. Return to supplier f or reuse/ recycling if possible. Otherwise: If container can not be cleaned suf f iciently well to ensure that residuals do not remain or if the container cannot be used to store the same product, and then puncture containers, to prevent re-use, and bury at an authorized landf ill. Where possible retain label warnings and MSDS and observe all notices pertaining to the product. Legislation addressing waste disposal requirements may dif f er by country, state and/ or territory. Each user must ref er to laws operating in their area. A Hierarchy of Controls seems to be common - the user should investigate: Reduction. DO NOT allow wash water from cleaning or process equipment to enter drains. It may be necessary to collect all wash water f or treatment bef ore disposal. In all cases disposal to sewer may be subject to local laws and regulations and these should be considered f irst. Where in doubt contact the responsible authority. Recycle wherever possible. Consult manuf acturer f or recycling options or consult local or regional waste management authority f or disposal if no suitable treatment or disposal f acility can be identif ied. Dispose of by: burial in a land-f ill specif ically licenced to accept chemical and / or pharmaceutical wastes or Incineration in a licenced apparatus (af ter admixture with suitable combustible material) Decontaminate empty containers. Observe all label saf eguards until containers are cleaned and destroyed. According to the European Waste Catalogue, Waste Codes are not product specif ic but application specif ic. Waste Codes should be assigned by the User based on the application in which the product is used. Waste Treatment Methods Packaging Containers may still present a chemical hazard/ danger when empty. Return to supplier f or reuse/ recycling if possible. Otherwise: If container can not be cleaned suf f iciently well to ensure that residuals do not remain or if the container cannot be used to store the same product, and then puncture containers, to prevent re-use, and bury at an authorized landf ill. Where possible retain label warnings and MSDS and observe all notices pertaining to the product. Legislation addressing waste disposal requirements may dif f er by country, state and/ or territory. Each user must ref er to laws operating in their area. A Hierarchy of Controls seems to be common - the user should investigate: Reduction. DO NOT allow wash water from cleaning or process equipment to enter drains. It may be necessary to collect all wash water f or treatment bef ore disposal. In all cases disposal to sewer may be subject to local laws and regulations and these should be considered f irst. Where in doubt contact the responsible authority. Recycle wherever possible. Consult manuf acturer f or recycling options or consult local or regional waste management authority f or Disposal if no suitable treatment or disposal f acility can be identif ied. Dispose of by: burial in a land-f ill specif ically licenced to accept chemical and / or pharmaceutical wastes or Incineration in a licenced apparatus (af ter admixture with suitable combustible material) Decontaminate empty containers. Observe all label saf eguards until containers are cleaned and destroyed. According to the European Waste Catalogue, Waste Codes are not product specif ic but application specif ic. Waste Codes should be assigned by the User based on the application in which the product is used. Special Precautions Landfill or Incinerations No data available Other Information No data available Section 14: Transport Information UN Number 2811 UN Proper Shipping Name TOXIC SOLID, ORGANIC N.O.S. (Contains Baclof en). Transport Hazard Class(es) 6.1 Packaging Group III Environmental Hazards No data available. Section 15: Regulatory Information BACLOFEN (CAS: 106266-06-2) is f ound on the f ollowing regulatory lists; "European Customs Inventory of Chemical Substances (English)" This saf ety data sheet is in compliance with the f ollowing EU legislation and its adaptations as f ar as applicable - : 1907/2006/EC, (EC) No 1272/2008, 67/548/EEC, 1999/45/EC, 76/769/EEC, 98/24/EC, 92/85/EEC, 94/33/EC, 91/689/EEC, 1999/13/EC, OSHA 29 CFR 1910.1200 as well as the f ollowing British legislation: - The Control of Substances Hazardous to Health Regulations (COSHH) 2002 - COSHH Essentials - The Management of Health and Saf ety at Work Regulations 1999 Page 6 of 7 Section 16: Other Information Additional Information Unless otherwise specif ied data extracted from RTECS - Register of Toxic Ef f ects of Chemical Substances Asthmalike symptoms may continue f or months or even years af ter exposure to the material ceases. This may be due to a non-allergenic condition known as reactive airways dysf unction syndrome (RADS) which can occur f ollowing exposure to high levels of highly irritating compound. Allergic reactions which develop in the respiratory passages as bronchial asthma or rhinoconjunctivitis, are mostly the result of reactions of the allergen with specif ic antibodies of the IgE class and belong in their reaction rates to the manif estation of the immediate type. In addition to the allergen-specif ic potential f or causing respiratory sensitisation, the amount of the allergen, the exposure period and the genetically determined disposition of the exposed person are likely to be decisive. Particular attention is drawn to so-called atopic diathesis which is characterised by an increased susceptibility to allergic rhinitis, allergic bronchial asthma and atopic eczema (neurodermatitis) which is associated with increased IgE synthesis. Exogenous allergic alveolitis is induced essentially by allergen specif ic immune-complexes of the IgG type; cell-mediated reactions (T lymphocytes) may be involved. Such allergy is of the delayed type with onset up to f our hours f ollowing exposure. Contact allergies quickly manif est themselves as contact eczema, more rarely as urticaria or Quincke's oedema. The pathogenesis of contact eczema involves a cell-mediated (T lymphocytes) immune reaction of the delayed type. Exposure to the material f or prolonged periods may cause physical def ects in the developing embryo (teratogenesis). Prepared By Lisa Russell Revision Date 01/15/2019 14:52 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 7 of 7
